79C3C34C52B45572883A05D425EB0F82

Public Health Service Act

https://legcounsel.house.gov/Comps/PHSA-merged.pdf

http://leaux.net/URLS/ConvertAPI Text Files/1796CD71B2F8033DC80FFAA2124D16BA.en.txt

Examining the file media/Synopses/1796CD71B2F8033DC80FFAA2124D16BA.html:

This file was generated: 2020-12-01 05:19:38

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Captive/Exiled Population	captive	1
Political	Criminal Convictions	prisoners	5
Political	Illegal Activity	crime	9
Political	Illegal Activity	illegal	7
Political	Illegal Activity	unlawful	7
Political	Indigenous	indigenous	1
Political	Indigenous	native	55
Political	Refugee Status	refugee	1
Political	criminal	criminal	41
Political	migrant	migrant	11
Political	person in detention center	detained	5
Political	person under arrest	arrest	14
Political	political affiliation	party	97
Political	political affiliation	political	187
Political	stateless persons	nation	39
Political	vulnerable	vulnerable	15
Political	vulnerable	vulnerability	1
Health	Cognitive Impairment	cognitive	15
Health	Cognitive Impairment	impaired	6
Health	Cognitive Impairment	impairment	15
Health	Drug Dependence	dependence	7
Health	Drug Dependence	dependency	8
Health	Drug Usage	drug	577
Health	Drug Usage	influence	3
Health	Drug Usage	substance	471
Health	Drug Usage	usage	4
Health	HIV/AIDS	HIV	408
Health	HIV/AIDS	hiv/aids	0
Health	Healthy People	volunteers	10
Health	Mentally Disabled	disabled	12
Health	Mentally Disabled	mentally	8
Health	Mentally Disabled	disability	92
Health	Motherhood/Family	family	304
Health	Motherhood/Family	motherhood	3
Health	Physically Disabled	illness	139
Health	Physically Disabled	physically	5
Health	Physically Ill	sick	2
Health	Pregnant	pregnant	94
Health	Terminally Ill	terminal	1
Health	addiction	addicts	2
Health	alcoholism	alcoholic	5
Health	alcoholism	alcoholism	37
Health	degenerative conditions	degenerative	2
Health	ill	ill	34
Health	injured	injured	11
Health	patients in emergency situations	emergencies	76
Health	sexually transmitted disases	sexually transmitted	16
Health	sexually transmitted disases	std	1
Health	sexually transmitted disases	sti	4
Health	substance use	substance use	146
Health	visual impairment	blind	2
Social	Access to Social Goods	access	343
Social	Access to information	foia	1
Social	Age	age	189
Social	Child	child	314
Social	Child	children	498
Social	Elderly	elderly	26
Social	Ethnicity	ethnic	60
Social	Ethnicity	ethnicity	17
Social	Fetus/Neonate	fetus	11
Social	Fetus/Neonate	fetuses	5
Social	Homeless Persons	homeless	60
Social	Incarcerated	incarcerated	3
Social	Incarcerated	jail	3
Social	Incarcerated	liberty	3
Social	Incarcerated	prison	2
Social	Incarcerated	restricted	12
Social	Infant	infant	58
Social	Institutionalized	institutionalized	1
Social	LGBTQ+ Status	homosexual	4
Social	Linguistic Proficiency	language	44
Social	Linguistic Proficiency	linguistic	15
Social	Literacy	literacy	11
Social	Marital Status	married	1
Social	Marital Status	single	91
Social	Marital Status	unmarried	6
Social	Mothers	mothers	13
Social	Occupation	job	9
Social	Occupation	occupation	1
Social	Police Officer	officer	329
Social	Police Officer	police	7
Social	Property Ownership	home	158
Social	Property Ownership	property	87
Social	Racial Minority	minority	177
Social	Racial Minority	race	20
Social	Racial Minority	racial	71
Social	Religion	faith	18
Social	Religion	belief	8
Social	Religion	conviction	4
Social	Religion	religion	7
Social	Religion	religious	53
Social	Soldier	armed forces	9
Social	Soldier	army	14
Social	Soldier	military	64
Social	Student	student	192
Social	Threat of Stigma	stigma	7
Social	Threat of Stigma	threat	51
Social	Threat of Violence	violence	100
Social	Trade Union Membership	union	1
Social	Unemployment	unemployment	1
Social	Victim of Abuse	trauma	297
Social	Victim of Abuse	victim	36
Social	Victim of Abuse	abuse	445
Social	Women	women	339
Social	Youth/Minors	minor	61
Social	Youth/Minors	youth	119
Social	education	education	859
Social	education	educational	193
Social	education	schooling	1
Social	embryo	embryo	5
Social	employees	employees	224
Social	ethnic minority	ethnic minority	11
Social	gender	gender	12
Social	in child protective services	child protective services	1
Social	orphan	orphan	6
Social	parents	parent	47
Social	parents	parents	82
Social	persons with care obligations	caretaker	2
Social	philosophical differences/differences of opinion	opinion	12
Economic	Economic/Poverty	poor	6
Economic	Economic/Poverty	poverty	56
Economic	Economic/Poverty	low-income	32
Economic	investors/intellectual rights	investors	1
General/Other	Dependent	dependent	60
General/Other	Developing Country	underdeveloped	1
General/Other	Diminished Autonomy	diminished	2
General/Other	Incapacitated	incapacitated	2
General/Other	Natural Hazards	hazard	6
General/Other	Other Country	foreign country	2
General/Other	Other Country	other country	2
General/Other	Public Emergency	emergency	559
General/Other	Relationship to Authority	authority	302
General/Other	cultural difference	culturally	34
General/Other	remote/rural communities	rural area	7
General/Other	whistleblower	whistleblower	3

Political / Captive/Exiled Population

Searching for indicator captive:

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p.000651: (3) and is satisfactory to the Secretary.
p.000651: (B) The terms of service for members of such board are in accordance with paragraph (3).
p.000651: (C) The members of the board serve without com- pensation. The members may be reimbursed for travel,
p.000651: subsistence, and other necessary expenses incurred in car- rying out the duties of the board.
p.000651: (D) The entity has an executive director meeting such requirements as the Secretary determines to be appro-
p.000651: priate.
p.000651: (E) The entity makes the agreement described in para- graph (4) (relating to non-Federal contributions).
p.000651: (F) The entity agrees to comply with standards under subsection (d).
p.000651: (G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a
p.000651: rea- sonable basis to persons who conduct biomedical or behav- ioral research, with priority given to such persons who
p.000651: are Federal employees or who receive financial support from the Federal Government for research.
p.000651: (H) Such other requirements as the Secretary deter- mines to be appropriate.
p.000651: (3) BOARD OF DIRECTORS.—For purposes of subparagraphs
p.000651: (A) and (B) of paragraph (2):
p.000651: (A) The governing board of directors of the nonprofit private entity involved is composed and appointed
p.000651: in ac- cordance with this paragraph if the following conditions are met:
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p.000651: January 30, 2020
p.000651: (i) Such board is composed of not more than 13 voting members.
p.000651: (ii) Such members include individuals with exper- tise and experience in the science of managing captive chimpanzees
p.000651: (including primate veterinary care), ap- pointed from among individuals endorsed by organiza- tions that represent
p.000651: individuals in such field.
p.000651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000653: 653
p.000653: PUBLIC HEALTH SERVICE ACT
p.000653: Sec. 404K
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p.000653: (iii) Such members include individuals with exper- tise and experience in the field of animal protection,
p.000653: appointed from among individuals endorsed by organi- zations that represent individuals in such field.
p.000653: (iv) Such members include individuals with exper- tise and experience in the zoological field (including
p.000653: behavioral primatology), appointed from among indi- viduals endorsed by organizations that represent indi- viduals
p.000653: in such field.
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Political / Criminal Convictions

Searching for indicator prisoners:

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p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 237 PUBLIC HEALTH SERVICE ACT 52
p.000017:
p.000017: AVAILABILITY OF APPROPRIATIONS
p.000017: SEC. 237. ø238f¿ Appropriations for carrying out the purposes of this Act shall be available for
p.000017: expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and
p.000017: exhibits; printing and binding; transporting in Government- owned automotive equipment, to and from school,
p.000017: children of per- sonnel who have quarters for themselves and their families at sta- tions determined by the
p.000017: Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who
p.000017: escape from any hospital, institution, or station of the Service or from the custody of any officer or employee
p.000017: of the Service, in- cluding rewards for the capture of such prisoners; furnishing, re- pairing, and
p.000017: cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the
p.000017: performance of their official duties; reimbursing officers and employees, subject to regulations of the
p.000017: Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients
p.000017: while such officers or employees are engaged in the performance of their official duties; and maintenance of
p.000017: buildings of the National Institutes of Health.
p.000017: UNAUTHORIZED WEARING OF UNIFORMS
p.000017: SEC. 238. ø238g¿ Except as may be authorized by regulations of the President, the insignia and uniform of
p.000017: commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia
p.000017: or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of
p.000017: such regulations, by any person other than a commissioned officer of the Service.
p.000017: BIANNUAL REPORT
p.000017: SEC. 239. ø238h¿ The Surgeon General shall transmit to the Secretary, for submission to the Congress, on
p.000017: January 1, 1995, and on January 1, every 2 years thereafter, a full report of the adminis- tration of the functions
p.000017: of the Service under this Act, including a detailed statement of receipts and disbursements.
p.000017: MEMORIALS AND OTHER ACKNOWLEDGMENTS
p.000017: SEC. 240. ø238i¿ The Secretary may provide for suitably ac- knowledging, within the Department (whether
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p.000253: January 30, 2020
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p.000253: CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN OTHER PERSONS
p.000253: SEC. 322. ø249¿ (a) Any person when detained in accordance with quarantine laws, or, at the request of
p.000253: the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for
p.000253: by the Public Health Service.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000255: 255
p.000255: PUBLIC HEALTH SERVICE ACT
p.000255: Sec. 324
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p.000255: (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in
p.000255: accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in
p.000255: case of emergency.
p.000255: (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with
p.000255: regulations, receive such care and treatment at the expense of the Service from public or private medical or
p.000255: hospital facilities other than those of the Service, when authorized by the officer in charge of the station
p.000255: at which the ap- plication is made.
p.000255: CARE AND TREATMENT OF FEDERAL PRISONERS 27
p.000255: SEC. 323. ø250¿ The Service shall supervise and furnish med- ical treatment and other necessary medical,
p.000255: psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended
p.000255: (U.S.C., 1940 edition, title 18, secs. 751, 752), 28 in penal and correctional institutions of the United
p.000255: States.
p.000255: EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES
p.000255: SEC. 324. ø251¿ (a) The Surgeon General is authorized to pro- vide at institutions, hospitals, and stations of
p.000255: the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under
p.000255: the United States Employees’ Compensation Act 29 and extensions thereof. The Surgeon General may also provide
p.000255: for making medical examinations of—
p.000255: (1) employees of the Federal Government for retirement purposes;
p.000255: (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service
p.000255: Commission for the purpose of promoting health and efficiency;
p.000255: (3) seamen for purposes of qualifying for certificates of service; and
p.000255: (4) employees eligible for benefits under the Longshore- men’s and Harbor Workers’ Compensation Act, as
p.000255: amended (U.S.C. 1940 edition, title 33, chapter 18), 30 as requested by any deputy commissioner thereunder.
p.000255: (b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and
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p.000305: by a city or county health de- partment, and community health center and which is not rea- sonably
p.000305: accessible to an adequately served area;
p.000305: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000307: PUBLIC HEALTH SERVICE ACT
p.000307: Sec. 332
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p.000307: January 30, 2020
p.000307: (B) such a facility of a State correctional institution or of the Indian Health Service, and a health program
p.000307: or facility op- erated by a tribe or tribal organization under the Indian Self- Determination Act;
p.000307: (C) such a facility used in connection with the delivery of health services under section 321 (relating
p.000307: to hospitals), 322 (relating to care and treatment of persons under quarantine and others), 323 (relating
p.000307: to care and treatment of Federal prisoners), 324 (relating to examination and treatment of cer- tain
p.000307: Federal employees), 325 (relating to examination of aliens), 326 (relating to services to certain Federal
p.000307: employees), 320 (relating to services for persons with Hansen’s disease), or 330(h) (relating to the provision of
p.000307: health services to homeless individuals); and
p.000307: (D) a Federal medical facility.
p.000307: (3) Homeless individuals (as defined in section 330(h)(5)), sea- sonal agricultural workers (as defined in
p.000307: section 330(g)(3)) and mi- gratory agricultural workers (as so defined)), and residents of pub- lic housing (as defined
p.000307: in section 3(b)(1) of the United States Hous- ing Act of 1937 (42 U.S.C. 1437a(b)(1))) may be population
p.000307: groups under paragraph (1).
p.000307: (b) The Secretary shall establish by regulation criteria for the designation of areas, population
p.000307: groups, medical facilities, and other public facilities, in the States, as health professional shortage areas.
p.000307: In establishing such criteria, the Secretary shall take into consideration the following:
p.000307: (1) The ratio of available health manpower to the number of individuals in an area or population group, or
p.000307: served by a medical facility or other public facility under consideration for designation.
p.000307: (2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the
p.000307: individuals in an area or population group or served by a medical facility or other public facility under
p.000307: consideration for designation.
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p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
p.001443: (A) IN GENERAL.—In providing for a council for pur- poses of paragraph (1), a chief elected official
p.001443: receiving a grant under section 2601(a) may establish the council di- rectly or designate an existing entity
p.001443: to serve as the coun- cil, subject to subparagraph (B).
p.001443: (B) CONSIDERATION REGARDING DESIGNATION OF COUN- CIL.—In making a determination of whether to establish or
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: PUBLIC HEALTH SERVICE ACT
p.001445: Sec. 2602
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Political / Illegal Activity

Searching for indicator crime:

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p.000017: 65 PUBLIC HEALTH SERVICE ACT Sec. 266
p.000017:
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B), an eligible individual shall not be provided compensa- tion
p.000017: under this section for the first 5 work days of loss of employment income.
p.000017: (B) EXCEPTION.—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi-
p.000017: vidual is 10 or more work days.
p.000017: (5) TERMINATION OF BENEFITS.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employment income once the eligible individual involves reaches the age of 65.
p.000017: (d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) shall be in addition to
p.000017: any amounts received by an eligible individual under section 264.
p.000017: SEC. 266. ø239e¿ PAYMENT FOR DEATH.
p.000017: (a) DEATH BENEFIT.—
p.000017: (1) IN GENERAL.—The Secretary shall pay, in the case of an eligible individual whose death is determined to have
p.000017: resulted from a covered injury or injuries, a death benefit in the amount determined under
p.000017: paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public
p.000017: Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control
p.000017: and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the
p.000017: case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the
p.000017: survivor in the place of the parent).
p.000017: (2) BENEFIT AMOUNT.—
p.000017: (A) IN GENERAL.—The amount of the death benefit under paragraph (1) in a fiscal year shall equal
p.000017: the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under
p.000017: subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
p.000017: seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but
p.000017: subject to subparagraph (B).
p.000017: (B) REDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT INCOME.—The amount of the benefit as determined under
p.000017: subparagraph (A) shall be reduced by the total amount of any benefits paid under section 265 with
p.000017: respect to lost employment income.
p.000017: (3) LIMITATIONS.—
p.000017: (A) IN GENERAL.—No benefit is payable under para- graph (1) with respect to the death of an eligible individual
p.000017: if—
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: (i) a disability benefit is paid with respect to such individual under the Public Safety Officers’ Benefits
p.000017: Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of
p.000017: 1968 (42 U.S.C. 3796 et seq.); or
p.000017: (ii) a death benefit is paid or payable with respect to such individual under the Public Safety Officers’
p.000017: Benefits Program under subpart 1 of part L of title I
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017: Sec. 266 PUBLIC HEALTH SERVICE ACT 66
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p.000017:
p.000017: January 30, 2020
p.000017:
p.000017: of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.).
p.000017: (B) EXCEPTION IN THE CASE OF A LIMITATION ON AP- PROPRIATIONS FOR DISABILITY BENEFITS UNDER PSOB.—In
p.000017: the event that disability benefits available to an eligible individual under the Public Safety Officers’
p.000017: Benefits Pro- gram under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets
p.000017: Act of 1968 (42 U.S.C. 3796 et seq.) are reduced because of a limitation on appro- priations, and such reduction
p.000017: would affect the amount that would be payable under subparagraph (A) without regard to this subparagraph,
p.000017: benefits shall be available under paragraph (1) to the extent necessary to ensure that the survivor or
p.000017: survivors of such individual receives a total amount equal to the amount described in paragraph (2).
p.000017: (b) ELECTION IN CASE OF DEPENDENTS.—
p.000017: (1) IN GENERAL.—In the case of an eligible individual whose death is determined to have resulted from a
p.000017: covered in- jury or injuries, if the individual had one or more dependents under the age of 18, the legal
p.000017: guardian of the dependents may, in lieu of the death benefit under subsection (a), elect to re- ceive on
p.000017: behalf of the aggregate of such dependents payments in accordance with this subsection. An election under
p.000017: the pre- ceding sentence is effective in lieu of a request under sub- section (a) by an individual who
p.000017: is not the legal guardian of such dependents.
p.000017: (2) AMOUNT OF PAYMENTS.—Payments under paragraph (1) with respect to an eligible individual described in such
p.000017: para- graph shall be made as if such individual were an eligible indi- vidual to whom compensation would be paid
p.000017: under subsection
p.000017: (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such
p.000017: individual con- sidered to be an eligible individual described in subsection (c)(3)(B) of such section.
p.000017: (3) LIMITATIONS.—
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p.000403: thereafter while the individuals have such access, not less frequently than once every five years;
p.000403: (C) deny access to such agents and toxins by individ- uals whom the Attorney General has identified as
p.000403: re- stricted persons; and
p.000403: (D) limit or deny access to such agents and toxins by individuals whom the Attorney General has
p.000403: identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the
p.000403: individuals involved is deter- mined appropriate by the Secretary, in consultation with the Attorney General.
p.000403: (3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.—
p.000403: (A) IN GENERAL.—Upon the receipt of names and other identifying information under paragraph (2)(B), the Attor-
p.000403: ney General shall, for the sole purpose of identifying whether the individuals involved are within any
p.000403: of the cat- egories specified in subparagraph (B), promptly use crimi- nal, immigration, national security, and
p.000403: other electronic databases that are available to the Federal Government and are appropriate for such purpose.
p.000403: (B) CERTAIN INDIVIDUALS.—For purposes of subpara- graph (A), the categories specified in this subparagraph re-
p.000403: garding an individual are that—
p.000403: (i) the individual is a restricted person; or
p.000403: (ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
p.000403: (I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;
p.000403: (II) knowing involvement with an organiza- tion that engages in domestic or international ter- rorism (as defined
p.000403: in section 2331 of such title 18) or with any other organization that engages in in- tentional crimes of violence; or
p.000403: (III) being an agent of a foreign power (as de- fined in section 1801 of title 50, United States Code).
p.000403: (C) NOTIFICATION BY ATTORNEY GENERAL REGARDING SUBMITTED NAMES.—After the receipt of a name and other
p.000403: identifying information under paragraph (2)(B), the Attor- ney General shall promptly notify the Secretary
p.000403: whether the individual is within any of the categories specified in subparagraph (B).
p.000403: (4) NOTIFICATIONS BY SECRETARY.—The Secretary, after re- ceiving notice under paragraph (3) regarding an
p.000403: individual, shall promptly notify the registered person involved of whether the individual is granted or denied access
p.000403: under paragraph (2).
p.000403: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000405: 405
p.000405: PUBLIC HEALTH SERVICE ACT
p.000405: Sec. 351A
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p.001127: (B) Disclosure of nonidentifiable patient safety work product.
p.001127: (C) Disclosure of patient safety work product to grant- ees, contractors, or other entities carrying out
p.001127: research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by
p.001127: rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of
p.001127: protected health information would be allowed for such purpose under the HIPAA con- fidentiality
p.001127: regulations.
p.001127: (D) Disclosure by a provider to the Food and Drug Ad- ministration with respect to a product or activity regulated by
p.001127: the Food and Drug Administration.
p.001127: (E) Voluntary disclosure of patient safety work prod- uct by a provider to an accrediting body that accredits
p.001127: that provider.
p.001127: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001127:
p.001127:
p.001127:
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p.001127:
p.001129: 1129
p.001129: PUBLIC HEALTH SERVICE ACT
p.001129: Sec. 922
p.001129:
p.001129: (F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations
p.001129: and are consistent with the goals of this part.
p.001129: (G) Disclosure of patient safety work product to law enforcement authorities relating to the commission
p.001129: of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes,
p.001129: reasonably under the circumstances, that the patient safety work product that is disclosed is necessary
p.001129: for criminal law en- forcement purposes.
p.001129: (H) With respect to a person other than a patient safe- ty organization, the disclosure of patient safety work prod-
p.001129: uct that does not include materials that—
p.001129: (i) assess the quality of care of an identifiable pro- vider; or
p.001129: (ii) describe or pertain to one or more actions or failures to act by an identifiable provider.
p.001129: (3) EXCEPTION FROM PRIVILEGE.—Subsection (a) shall not apply to (and shall not be construed to prohibit)
p.001129: voluntary dis- closure of nonidentifiable patient safety work product.
p.001129: (d) CONTINUED PROTECTION OF INFORMATION AFTER DISCLO-
p.001129: SURE.—
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p.001129: January 30, 2020
p.001129: (1) IN GENERAL.—Patient safety work product that is dis-
p.001129: closed under subsection (c) shall continue to be privileged and confidential as provided for in subsections
p.001129: (a) and (b), and such disclosure shall not be treated as a waiver of privilege or con- fidentiality, and the
p.001129: privileged and confidential nature of such work product shall also apply to such work product in the pos- session or
p.001129: control of a person to whom such work product was disclosed.
...

p.001641: (B) any identified measures to address such shortage.
p.001641: (4) CERTAIN APPOINTMENTS.—
p.001641: (A) IN GENERAL.—If the Secretary determines that the number of intermittent disaster response personnel within the
p.001641: National Disaster Medical System under this section is insufficient to address a public health emergency or poten- tial
p.001641: public health emergency, the Secretary may appoint candidates directly to personnel positions for
p.001641: intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant
p.001641: or unfilled posi- tions within such system to the congressional committees
p.001641: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001641:
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p.001641: Sec. 2812 PUBLIC HEALTH SERVICE ACT 1642
p.001641:
p.001641: of jurisdiction each quarter for which this authority is in effect.
p.001641: (B) SUNSET.—The authority under this paragraph shall expire on September 30, 2021.
p.001641: (5) 1 SERVICE BENEFIT.—Individuals appointed to serve under this subsection shall be considered
p.001641: eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The
p.001641: Secretary shall provide notification to any eligible individual of any effect such designation may have on other
p.001641: benefits for which such individual is eligible, includ- ing benefits from private entities.
p.001641: (d) CERTAIN EMPLOYMENT ISSUES REGARDING INTERMITTENT APPOINTMENTS.—
p.001641: (1) INTERMITTENT DISASTER-RESPONSE APPOINTEE.—For purposes of this subsection, the term ‘‘intermittent
p.001641: disaster-re- sponse appointee’’ means an individual appointed by the Sec- retary under subsection (c).
p.001641: (2) COMPENSATION FOR WORK INJURIES.—
p.001641: (A) IN GENERAL.—An intermittent disaster-response appointee shall, while acting in the scope of such appoint-
p.001641: ment, be considered to be an employee of the Public Health Service performing medical, surgical,
p.001641: dental, or re- lated functions, and an injury sustained by such an indi- vidual shall be deemed ‘‘in the
p.001641: performance of duty’’, for purposes of chapter 81 of title 5, United States Code, per- taining to compensation for
p.001641: work injuries.
p.001641: (B) APPLICATION TO TRAINING PROGRAMS.—With re- spect to the participation of individuals appointed under
p.001641: subsection (c) in training programs authorized by the As- sistant Secretary for Preparedness and Response or a
p.001641: com- parable official of any Federal agency specified in sub- section (a)(2)(B), injuries sustained by
p.001641: such an individual, while acting within the scope of such participation, also shall be deemed ‘‘in the
p.001641: performance of duty’’ for purposes of chapter 81 of title 5, United States Code (regardless of whether the
p.001641: individuals receive compensation for such par- ticipation).
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p.000001: (A) IN GENERAL.—A covered person shall cooperate with the United States in the processing and defense of
p.000001: a claim or action under this subsection based upon alleged acts or omissions of such person.
p.000001: (B) CONSEQUENCES OF FAILURE TO COOPERATE.—Upon the motion of the United States or any other party and
p.000001: upon finding that such person has failed to so cooperate—
p.000001: (i) the court shall substitute such person as the party defendant in place of the United States and,
p.000001: upon motion, shall remand any such suit to the court in which it was instituted if it appears that
p.000001: the court lacks subject matter jurisdiction;
p.000001: (ii) the United States shall not be liable based on the acts or omissions of such person; and
p.000001: (iii) the Attorney General shall not be obligated to defend such action.
p.000001: (6) RECOURSE AGAINST COVERED PERSON IN CASE OF GROSS MISCONDUCT OR CONTRACT VIOLATION.—
p.000001: (A) IN GENERAL.—Should payment be made by the United States to any claimant bringing a claim under this
p.000001: subsection, either by way of administrative determination, settlement, or court judgment, the United States
p.000001: shall have, notwithstanding any provision of State law, the right to recover for that portion of the damages so
p.000001: awarded or paid, as well as interest and any costs of litigation, result- ing from the failure of any covered person
p.000001: to carry out any obligation or responsibility assumed by such person under a contract with the United States or from
p.000001: any grossly neg- ligent, reckless, or illegal conduct or willful misconduct on the part of such person.
p.000001: (B) VENUE.—The United States may maintain an ac- tion under this paragraph against such person in the
p.000001: dis- trict court of the United States in which such person re- sides or has its principal place of business.
p.000001: (7) DEFINITIONS.—As used in this subsection, terms have the following meanings:
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 40
p.000001:
p.000001: (A) COVERED COUNTERMEASURE.—The term ‘‘covered countermeasure’’ or ‘‘covered countermeasure against
p.000001: smallpox’’, means a substance that is—
p.000001: (i)(I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or
p.000001: (II) 12 used to control or treat the adverse ef- fects of vaccinia inoculation or of administration of another
p.000001: covered countermeasure; and
p.000001: (ii) specified in a declaration under paragraph (2).
p.000001: (B) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration of a covered
p.000001: countermeasure, means a person who is—
p.000001: (i) a manufacturer or distributor of such counter- measure;
p.000001: (ii) a health care entity under whose auspices 13—
p.000001: (I) such countermeasure was administered;
...

p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
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p.000865:
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p.000865:
p.000865: (VI) Evidence-based best practices to prevent and reduce underage drinking and provide treat- ment services
p.000865: to those youth who need them.
p.000865: (2) ANNUAL REPORT ON STATE UNDERAGE DRINKING PRE- VENTION AND ENFORCEMENT ACTIVITIES.—
p.000865: (A) IN GENERAL.—The Secretary shall, with input and collaboration from other appropriate Federal agencies,
p.000865: States, Indian tribes, territories, and public health, con- sumer, and alcohol beverage industry groups,
p.000865: annually issue a report on each State’s performance in enacting, en- forcing, and creating laws, regulations, and
p.000865: programs to prevent or reduce underage drinking.
p.000865: (B) STATE PERFORMANCE MEASURES.—
p.000865: (i) IN GENERAL.—The Secretary shall develop, in consultation with the Committee, a set of measures to be used in
p.000865: preparing the report on best practices.
p.000865: (ii) CATEGORIES.—In developing these measures, the Secretary shall consider categories including, but not
p.000865: limited to:
p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
...

p.001313: $4,000 and each such loan is repaid to the revolving fund by the residents of the housing involved not
p.001313: later than 2 years after the date on which the loan is made.
p.001313: (5) Each such loan is repaid by such residents through monthly installments, and a reasonable penalty is
p.001313: assessed for each failure to pay such periodic installments by the date spec- ified in the loan agreement involved.
p.001313: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001313:
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p.001313: Sec. 1926 PUBLIC HEALTH SERVICE ACT 1314
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p.001313:
p.001313:
p.001313: January 30, 2020
p.001313:
p.001313: (6) Such loans are made only to nonprofit private entities agreeing that, in the operation of the program
p.001313: established pur- suant to the loan—
p.001313: (A) the use of alcohol or any illegal drug in the hous- ing provided by the program will be prohibited;
p.001313: (B) any resident of the housing who violates such pro- hibition will be expelled from the housing;
p.001313: (C) the costs of the housing, including fees for rent and utilities, will be paid by the residents of the
p.001313: housing; and
p.001313: (D) the residents of the housing will, through a major- ity vote of the residents, otherwise establish policies
p.001313: gov- erning residence in the housing, including the manner in which applications for residence in the
p.001313: housing are ap- proved.
p.001313: (b) ISSUANCE BY SECRETARY OF GUIDELINES.—The Secretary shall ensure that there are in effect
p.001313: guidelines under this subpart for the operation of programs described in subsection (a).
p.001313: (c) APPLICABILITY TO TERRITORIES.—The requirements estab- lished in subsection (a) shall not apply to any
p.001313: territory of the United States other than the Commonwealth of Puerto Rico.
p.001313: SEC. 1926. ø300x–26¿ SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 21.
p.001313: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved will—
p.001313: (1) annually conduct random, unannounced inspections to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21; and
p.001313: (2) annually submit to the Secretary a report describing—
p.001313: (A) the activities carried out by the State to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21;
...

p.001381: (d) PUNITIVE DAMAGES.—
p.001381: (1) If sought by the plaintiff, the third stage of such an ac- tion shall be held to determine the amount of
p.001381: punitive dam-
p.001381:
p.001381:
p.001381:
p.001381: January 30, 2020
p.001381: 24 Effective October 1, 1988.
p.001381:
p.001381: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001381:
p.001381:
p.001381:
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p.001381:
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p.001381:
p.001381: Sec. 2125 PUBLIC HEALTH SERVICE ACT 1382
p.001381:
p.001381: ages a vaccine manufacturer found to be liable under section 2122 shall be required to pay.
p.001381: (2) If in such an action the manufacturer shows that it complied, in all material respects, with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act applicable to
p.001381: the vaccine and related to the vaccine injury or death with respect to which the action was brought, the
p.001381: manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
p.001381: (A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a pro-
p.001381: ceeding for approval of the vaccine under section 351,
p.001381: (B) intentional and wrongful withholding of informa- tion relating to the safety or efficacy of the
p.001381: vaccine after its approval, or
p.001381: (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
p.001381: which activity related to the vaccine-related injury or death for which the civil action was brought.
p.001381: (e) EVIDENCE.—In any stage of a civil action, the Vaccine In- jury Table, any finding of fact or
p.001381: conclusion of law of the United States Claims Court or a special master in a proceeding on a peti- tion filed
p.001381: under section 2111 and the final judgment of the United States Claims Court and subsequent appellate review on such a
p.001381: pe- tition shall not be admissible.
p.001381: PART C—ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES
p.001381:
p.001381:
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p.001381:
p.001381:
p.001381: January 30, 2020
p.001381:
p.001381: RECORDING AND REPORTING OF INFORMATION
p.001381: SEC. 2125. ø300aa–25¿ (a) GENERAL RULE.—Each health care provider who administers a vaccine set forth in the
p.001381: Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person’s permanent
p.001381: medical record (or in a permanent of- fice log or file to which a legal representative shall have
p.001381: access upon request) with respect to each such vaccine—
p.001381: (1) the date of administration of the vaccine,
p.001381: (2) the vaccine manufacturer and lot number of the vac- cine,
p.001381: (3) the name and address and, if appropriate, the title of the health care provider administering the
p.001381: vaccine, and
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p.000317: the extent that such utilization will not impair the delivery of health services and treatment
p.000317: through such hospital or facility to individuals who are entitled to health services and treatment through such
p.000317: hospital or facility.
p.000317: (c) The Secretary may make one loan to any entity with an ap- proved application under section 333 to assist such
p.000317: entity in meet- ing the costs of (1) establishing medical, dental, or other health profession practices,
p.000317: including the development of medical practice management systems; (2) acquiring equipment for use in providing health
p.000317: services; and (3) renovating buildings to establish health fa- cilities. No loan may be made under this
p.000317: subsection unless an ap- plication therefor is submitted to, and approved by, the Secretary. The amount of
p.000317: any such loan shall be determined by the Secretary, except that no such loan may exceed $50,000.
p.000317: (d) Upon the expiration of the assignment of all Corps mem- bers to a health professional shortage area, the
p.000317: Secretary may (not- withstanding any other provision of law) sell, to any appropriate local entity, equipment
p.000317: and other property of the United States uti- lized by such members in providing health services. Sales made
p.000317: under this subsection shall be made at the fair market value (as determined by the Secretary) of the
p.000317: equipment or such other prop- erty; except that the Secretary may make such sales for a lesser value to an
p.000317: appropriate local entity, if he determines that the enti- ty is financially unable to pay the full market value.
p.000317: (e)(1)(A) It shall be unlawful for any hospital to deny an au- thorized Corps member admitting
p.000317: privileges when such Corps member otherwise meets the professional qualifications established by the hospital for
p.000317: granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws,
p.000317: rules, and regulations of its medical staff.
p.000317: (B) Any hospital which is found by the Secretary, after notice and an opportunity for a hearing on the
p.000317: record, to have violated this subsection shall upon such finding cease, for a period to be de- termined by the
p.000317: Secretary, to receive and to be eligible to receive any Federal funds under this Act or under titles XVIII,
p.000317: XIX, or XXI of the Social Security Act.
p.000317: (2) For purposes of this subsection, the term ‘‘hospital’’ includes a State or local public hospital, a private
p.000317: profit hospital, a private nonprofit hospital, a general or special hospital, and any other type of hospital
p.000317: (excluding a hospital owned or operated by an agency of the Federal Government), and any related facilities.
p.000317: SEC. 336. ø254h–1¿ FACILITATION OF EFFECTIVE PROVISION OF CORPS SERVICES.
p.000317: (a) CONSIDERATION OF INDIVIDUAL CHARACTERISTICS OF MEM- BERS IN MAKING ASSIGNMENTS.—In making an
p.000317: assignment of a Corps member to an entity that has had an application approved under section 333, the
p.000317: Secretary shall, subject to making the as- signment in accordance with section 333A, seek to assign to the en-
p.000317: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000317:
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...

p.000443: shall be estab- lished by regulation.
p.000443: (b) Original bills of health shall be delivered to the collectors
p.000443: of customs at the port of entry. Duplicate copies of such bills of health shall be delivered at the time of
p.000443: inspection to quarantine of- ficers at such port. The bills of health herein prescribed shall be considered
p.000443: as part of the ship’s papers, and when duly certified to by the proper consular or other officer of the United
p.000443: States, over his official signature and seal, shall be accepted as evidence of the statements therein contained in
p.000443: any court of the United States.
p.000443: (c) The Surgeon General shall from time to time prescribe reg- ulations, applicable to vessels referred to in
p.000443: subsection (a) of this section for the purpose of preventing the introduction into the States or
p.000443: possessions of the United States of any communicable dis- ease by securing the best sanitary condition of such
p.000443: vessels, their cargoes, passengers, and crews. Such regulations shall be observed by such vessels prior to departure,
p.000443: during the course of the voyage, and also during inspection, disinfection, or other quarantine proce- dure upon arrival
p.000443: at any United States quarantine station.
p.000443: (d) The provisions of subsections (a) and (b) of this section shall not apply to vessels plying between such
p.000443: foreign ports on or near the frontiers of the United States and ports of the United States as are
p.000443: designated by treaty.
p.000443: (e) It shall be unlawful for any vessel to enter any port in any State or possession of the United States to
p.000443: discharge its cargo, or land its passengers, except upon a certificate of the quarantine offi- cer that regulations
p.000443: prescribed under subsection (c) have in all re- spects been complied with by such officer, the vessel, and its mas-
p.000443: ter. The master of every such vessel shall deliver such certificate to the collector of customs at the
p.000443: port of entry, together with the original bill of health and other papers of the vessel. The certificate required
p.000443: by this subsection shall be procurable from the quarantine officer, upon arrival of the vessel at the quarantine
p.000443: station and sat- isfactory inspection thereof, at any time within which quarantine services are performed at
p.000443: such station.
p.000443: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000443:
p.000443:
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p.000443:
p.000445: 445
p.000445: PUBLIC HEALTH SERVICE ACT
p.000445: Sec. 371
p.000445:
p.000445: CIVIL AIR NAVIGATION AND CIVIL AIRCRAFT
p.000445: SEC. 367. ø270¿ The Surgeon General is authorized to provide by regulations for the application to air
p.000445: navigation and aircraft of any of the provisions of sections 364, 365, and 366 and regulations prescribed thereunder
p.000445: (including penalties and forfeitures for viola- tions of such sections and regulations), to such extent and
...

p.000445: organization which, as determined by the Secretary, will carry out the functions de- scribed in paragraph (2)
p.000445: 77 and—
p.000445: (A) is a nonprofit entity,
p.000445: (B) has accounting and other fiscal procedures (as specified by the Secretary) necessary to assure the fiscal stability
p.000445: of the organization,
p.000445: (C) has an agreement with the Secretary to be reimbursed under title XVIII of the Social Security Act for the
p.000445: procurement of kidneys,
p.000445: (D) notwithstanding any other provision of law, has met the other requirements of this section and has been
p.000445: certified or recertified by the Secretary within the previous 4-year period as meeting the performance
p.000445: standards to be a qualified organ procurement organization through a process that either—
p.000445: (i) granted certification or recertification within such 4-year period with such certification or recertification
p.000445: in ef- fect as of January 1, 2000, and remaining in effect through the earlier of—
p.000445: (I) January 1, 2002; or
p.000445: (II) the completion of recertification under the re- quirements of clause (ii); or
p.000445: (ii) is defined through regulations that are promul- gated by the Secretary by not later than January 1, 2002,
p.000445: that—
p.000445: (I) require recertifications of qualified organ pro- curement organizations not more frequently than once every 4
p.000445: years;
p.000445:
p.000445:
p.000445:
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p.000445:
p.000445:
p.000445: January 30, 2020
p.000445: SEC. 301. (a) It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer
p.000445: any human organ for valuable consideration for use in human transplantaion if the transfer affects
p.000445: interstate commerce.
p.000445: (b) Any person who violates subsection (a) shall be fined not more than $50,000 or imprisoned not more than five years,
p.000445: or both.
p.000445: (c) For purposes of subsection (a):
p.000445: (1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow,
p.000445: cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof,
p.000445: including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
p.000445: (2) The term ‘‘valuable consideration’’ does not include the reasonable payments associ- ated with the
p.000445: removal, transportation, implantation, processing, preservation, quality con- trol, and storage of a human
p.000445: organ or the expenses of travel, housing, and lost wages in- curred by the donor of a human organ in
p.000445: connection with the donation of the organ.
p.000445: (3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 201(b) of the Federal
p.000445: Food, Drug and Cosmetic Act.
p.000445: 76 So in law. Subparagraphs (D) and (E) have the same text, and there are two subparagraphs (H). This results from the
p.000445: same set of amendments to section 371(b)(1) being enacted twice. The first set of amendments was made by section
p.000445: 701(c) of Public Law 106–505 (114 Stat. 2347). These amendments redesignated subparagraphs (D) through (G) as
...

p.000535: (2) the consultation of the PDMP by each prescribing prac- titioner, or their designee, in the State or
p.000535: locality before initi- ating treatment with a controlled substance, or any substance as required by the State
p.000535: to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event;
p.000535: (3) the consultation of the PDMP before dispensing a con- trolled substance, or any substance as required by the State
p.000535: to be reported to the PDMP;
p.000535: (4) the proactive notification to a practitioner when pat- terns indicative of controlled substance misuse by a
p.000535: patient, in- cluding opioid misuse, are detected;
p.000535: (5) the availability of data in the PDMP to other States, as allowable under State law; and
p.000535: (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for
p.000535: surveillance, epidemiology, statistical research, or educational purposes.
p.000535: (c) DRUG MISUSE AND ABUSE.—In consultation with practi- tioners, dispensers, and other relevant and interested
p.000535: stakeholders, a State receiving support under this section—
p.000535: (1) shall establish a program to notify practitioners and dispensers of information that will help to identify
p.000535: and prevent the unlawful diversion or misuse of controlled substances;
p.000535: (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for
p.000535: carrying out drug diversion investigations if the State determines that informa- tion in the PDMP maintained
p.000535: by the State indicates an unlaw- ful diversion or abuse of a controlled substance;
p.000535: (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State
p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000535:
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p.000535:
p.000535: Sec. 399O PUBLIC HEALTH SERVICE ACT 536
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p.000813: dead human em- bryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000813:
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p.000813: Sec. 498B PUBLIC HEALTH SERVICE ACT 814
p.000813:
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p.000813: January 30, 2020
p.000813:
p.000813: PROHIBITIONS REGARDING HUMAN FETAL TISSUE
p.000813: SEC. 498B. ø289g–2¿ (a) PURCHASE OF TISSUE.—It shall be un-
p.000813: lawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for
p.000813: valuable consideration if the transfer affects interstate commerce.
p.000813: (b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DO- NATION FOR USE IN TRANSPLANTATION.—It shall
p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
p.000813: (3) The term ‘‘valuable consideration’’ does not include rea- sonable payments associated with the transportation,
p.000813: implan- tation, processing, preservation, quality control, or storage of human fetal tissue.
...

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p.001307:
p.001307:
p.001309: 1309
p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
p.001309: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
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p.001273: receive, and eliminating racial and ethnic disparities. In carrying out this subsection, the Secretary, acting
p.001273: through the Deputy Assistant Sec- retary, shall award grants, contracts, enter into memoranda of un- derstanding,
p.001273: cooperative, interagency, intra-agency and other agreements with public and nonprofit private entities,
p.001273: agencies, as well as Departmental and Cabinet agencies and organizations, and
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001273:
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p.001273: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1274
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p.001273: January 30, 2020
p.001273:
p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
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p.000111: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall,
p.000111: for the payment of ex- penses incurred in complying with such request, expend the amounts withheld.
p.000111: (3) APPLICATION FOR AWARD.—The Secretary may make an award of a grant or contract under paragraph (1) only if an ap-
p.000111: plication for the award is submitted to the Secretary and the application is in such form, is made in such
p.000111: manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to
p.000111: carry out the purposes for which the award is to be made.
p.000111: (c) BIENNIAL REPORT.—Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the
p.000111: Secretary shall submit to the Committee on Commerce of the House of Representa- tives, and the Committee on Labor
p.000111: and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
p.000111: (1) contains information regarding the incidence and prev- alence of birth defects, developmental
p.000111: disabilities, and the health status of individuals with disabilities and the extent to which these conditions
p.000111: have contributed to the incidence and prevalence of infant mortality and affected quality of life;
p.000111: (2) contains information under paragraph (1) that is spe- cific to various racial and ethnic groups
p.000111: (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
p.000111: (3) contains an assessment of the extent to which various approaches of preventing birth defects,
p.000111: developmental disabil- ities, and secondary health conditions among individuals with disabilities have been
p.000111: effective;
p.000111: (4) describes the activities carried out under this section;
p.000111: (5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or
p.000111: develop- mental disabilities, information on the health status of individ- uals with disabilities, information on any
p.000111: health disparities ex- perienced by such individuals, and recommendations for im- proving the health and
p.000111: wellness and quality of life of such indi- viduals;
p.000111: (6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Dis-
p.000111: ease Control and Prevention, including conferences related to spina bifida; and
p.000111: (7) contains any recommendations of the Secretary regard- ing this section.
p.000111: (d) APPLICABILITY OF PRIVACY LAWS.—The provisions of this section shall be subject to the requirements of
p.000111: section 552a of title 5, United States Code. All Federal laws relating to the privacy of information shall
p.000111: apply to the data and information that is col- lected under this section.
p.000111: (e) ADVISORY COMMITTEE.—Notwithstanding any other provi- sion of law, the members of the advisory
p.000111: committee appointed by
p.000111: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000133: erators and other Indian Health Service personnel working directly with fluoridation projects.
p.000133: (ii) LIAISON.—A fluoridation specialist shall serve as the principal technical liaison between the Indian
p.000133: Health Service and the Centers for Disease Control and Prevention with respect to engineering and fluori- dation
p.000133: issues.
p.000133: (iii) CDC.—The Director of the Centers for Dis- ease Control and Prevention shall appoint individuals to
p.000133: serve as the fluoridation specialists.
p.000133: (D) IMPLEMENTATION.—The project established under this subsection shall be planned, implemented and evalu-
p.000133: ated over the 5-year period beginning on the date on which funds are appropriated under this section and shall be de-
p.000133: signed to serve as a model for improving the effectiveness of water fluoridation systems of small rural
p.000133: communities.
p.000133: (3) EVALUATION.—In conducting the ongoing evaluation as provided for in paragraph (2)(D), the Secretary shall
p.000133: ensure that such evaluation includes—
p.000133: (A) the measurement of changes in water fluoridation compliance levels resulting from assistance provided under
p.000133: this section;
p.000133: (B) the identification of the administrative, technical and operational challenges that are unique to the
p.000133: fluorida- tion of small water systems;
p.000133: (C) the development of a practical model that may be easily utilized by other tribal, State, county or
p.000133: local gov- ernments in improving the quality of water fluoridation with emphasis on small water systems; and
p.000133: (D) the measurement of any increased percentage of Native Americans or Alaskan Natives who receive the ben-
p.000133: efits of optimally fluoridated water.
p.000133: (c) SCHOOL-BASED DENTAL SEALANT PROGRAM.—
p.000133: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention
p.000133: and in collaboration with the Administrator of the Health Resources and Services Administration, shall
p.000133: award a grant to each of the 50 States and territories and to Indians, Indian tribes, trib- al organizations
p.000133: and urban Indian organizations (as such
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000133: Sec. 317M PUBLIC HEALTH SERVICE ACT 134
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p.000133: terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development
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p.000345: agrees—
p.000345: (1) to submit to the Secretary reports or performance data containing such information as the Secretary may
p.000345: require re- garding activities carried out under this section; and
p.000345: (2) to submit such a report or performance data not later than September 30 of each fiscal year
p.000345: immediately following any fiscal year for which the State office of rural health has received such a grant.
p.000345: (g) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.000345: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.000345: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.000345: be nec- essary to carry out such subsection.
p.000345: (h) NONCOMPLIANCE.—The Secretary may not make payments under subsection (a) to a State office of rural
p.000345: health for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines
p.000345: that, for the immediately preceding fiscal year, the State office of rural health has complied with each of the
p.000345: agreements made by the State office of rural health under this sec- tion.
p.000345: (i) AUTHORIZATION OF APPROPRIATIONS.—
p.000345: (1) IN GENERAL.—For the purpose of making grants under subsection (a), there are authorized to be
p.000345: appropriated
p.000345: $12,500,000 for each of fiscal years 2018 through 2022.
p.000345: (2) AVAILABILITY.—Amounts appropriated under paragraph
p.000345: (1) shall remain available until expended.
p.000345: SEC. 338K. ø254s¿ NATIVE HAWAIIAN HEALTH SCHOLARSHIPS.
p.000345: (a) Subject to the availability of funds appropriated under the authority of subsection (d), the Secretary
p.000345: shall provide scholarship
p.000345: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000345:
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p.000345: Sec. 338L PUBLIC HEALTH SERVICE ACT 346
p.000345:
p.000345: assistance, pursuant to a contract with the Papa Ola Lokahi, to students who—
p.000345: (1) meet the requirements of section 338A(b), and
p.000345: (2) are Native Hawaiians.
p.000345: (b)(1) The scholarship assistance provided under subsection (a) shall be provided under the same terms and
p.000345: subject to the same conditions, regulations, and rules that apply to scholarship assist- ance provided under
p.000345: section 338A.
p.000345: (2) The Native Hawaiian Health Scholarship program shall not be administered by or through the Indian Health Service.
p.000345: (c) For purposes of this section, the term ‘‘Native Hawaiian’’ means any individual who is—
p.000345: (1) a citizen of the United States,
p.000345: (2) a resident of the State of Hawaii, and
p.000345: (3) a descendant of the aboriginal people, who prior to 1778, occupied and exercised sovereignty in the area
p.000345: that now constitutes the State of Hawaii, as evidenced by—
p.000345: (A) genealogical records,
p.000345: (B) Kupuna (elders) or Kama’aina (long-term commu- nity residents) verification, or
p.000345: (C) birth records of the State of Hawaii.
p.000345: (d) There are authorized to be appropriated $1,800,000 for each of the fiscal years 1990, 1991, and 1992 for the
p.000345: purpose of funding the scholarship assistance provided under subsection (a).
p.000345: SEC. 338L. ø254t¿ DEMONSTRATION PROJECT.
p.000345: (a) PROGRAM AUTHORIZED.—The Secretary shall establish a demonstration project to provide for the participation of
p.000345: individuals who are chiropractic doctors or pharmacists in the Loan Repay- ment Program described in section
p.000345: 338B.
p.000345: (b) PROCEDURE.—An individual that receives assistance under this section with regard to the program
p.000345: described in section 338B shall comply with all rules and requirements described in such sec- tion (other than
p.000345: subparagraphs (A) and (B) of section 338B(b)(1)) in order to receive assistance under this section.
p.000345: (c) LIMITATIONS.—
p.000345: (1) IN GENERAL.—The demonstration project described in this section shall provide for the participation of
p.000345: individuals who shall provide services in rural and urban areas.
p.000345: (2) AVAILABILITY OF OTHER HEALTH PROFESSIONALS.—The Secretary may not assign an individual receiving
p.000345: assistance under this section to provide obligated service at a site un- less—
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p.000359: scription and which is prescribed by a physician (or other persons authorized to prescribe such drug under
p.000359: State law).
p.000359: (3) DRUGS PROVIDED UNDER STATE MEDICAID PLANS.— Drugs described in this paragraph are drugs purchased
p.000359: by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the
p.000359: Social Secu- rity Act.
p.000359: (4) COVERED ENTITY DEFINED.—In this section, the term ‘‘covered entity’’ means an entity that meets the
p.000359: requirements described in paragraph (5) and is one of the following:
p.000359: (A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act).
p.000359: (B) An entity receiving a grant under section 340A 46.
p.000359: (C) A family planning project receiving a grant or con- tract under section 1001.
p.000359: (D) An entity receiving a grant under subpart II of part C of title XXVI (relating to categorical grants for
p.000359: out- patient early intervention services for HIV disease).
p.000359: (E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under title XXVI.
p.000359: (F) A black lung clinic receiving funds under section 427(a) of the Black Lung Benefits Act.
p.000359: (G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the So-
p.000359: cial Security Act.
p.000359: (H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
p.000359: (I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act.
p.000359:
p.000359:
p.000359:
p.000359: January 30, 2020
p.000359: 46 See footnote on preceding page. See also footnote for section 217(a).
p.000359: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000361: 361
p.000361: PUBLIC HEALTH SERVICE ACT
p.000361: Sec. 340B
p.000361:
p.000361: (J) Any entity receiving assistance under title XXVI (other than a State or unit of local government or an
p.000361: entity described in subparagraph (D)), but only if the entity is certified by the Secretary pursuant to
p.000361: paragraph (7).
p.000361: (K) An entity receiving funds under section 318 (relat- ing to treatment of sexually transmitted diseases) or
p.000361: sec- tion 317(j)(2) (relating to treatment of tuberculosis) through a State or unit of local government,
p.000361: but only if the entity is certified by the Secretary pursuant to paragraph (7).
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p.000489: Sec. 399
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p.000489: January 30, 2020
p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
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p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000491:
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p.000493: 493
p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
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p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
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p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
p.000507: Control, may make grants to States, or may make grants or enter into con- tracts with academic or
p.000507: nonprofit organizations designated by the State to operate the State’s cancer registry in lieu of mak- ing a grant
...

p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
p.000591:
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000591:
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p.000593: 593
p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
p.000593:
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p.000593: January 30, 2020
p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
p.000593: (1) IN GENERAL.—The Secretary, in consultation with the Director of the Centers for Disease Control and
p.000593: Prevention and the Administrator of the Health Resources and Services Ad- ministration, may award grants,
...

p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000829:
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p.000829: Sec. 501 PUBLIC HEALTH SERVICE ACT 830
p.000829:
p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
p.000829: ferred to in paragraph (3)), and report biannually to the Assistant Secretary regarding the extent to which
...

p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
p.000845: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000845: shall give priority to applicants that—
p.000845: (1) propose to provide alcohol and drug prevention or treat- ment services on reservations;
p.000845: (2) propose to employ culturally-appropriate approaches, as determined by the Secretary, in providing such services;
p.000845: and
p.000845: (3) have provided prevention or treatment services to Na- tive Alaskan entities and Indian tribes and tribal
p.000845: organizations for at least 1 year prior to applying for a grant under this sec- tion.
p.000845: (c) DURATION.—The Secretary shall award grants, contracts, or cooperative agreements under subsection (a) for a period
p.000845: not to ex- ceed 5 years.
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 5 Section 3307 of Public Law 106–310 (114 Stat. 1216) establishes a Commission on Indian and Native
p.000845: Alaskan Health Care and provides that the Commission ‘‘shall examine the health concerns of Indians and
p.000845: Native Alaskans who reside on reservations and tribal lands’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
p.000847: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000847: submit, in the ap- plication for such grant, a plan for the evaluation of any project un- dertaken with funds provided
p.000847: under this section. Such entity shall provide the Secretary with periodic evaluations of the progress of such
p.000847: project and such evaluation at the completion of such project as the Secretary determines to be appropriate.
p.000847: The final evaluation submitted by such entity shall include a recommendation as to whether such project shall
p.000847: continue.
p.000847: (f) REPORT.—Not later than 3 years after the date of the enact- ment of this section and annually thereafter,
p.000847: the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of
p.000847: the Senate, a report describing the services provided pursuant to this section.
...

p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: 925
p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
p.000925: Disorder Education for purposes of im- proving health professional training resources with respect to sub- stance
p.000925: use disorder prevention, treatment, and recovery.
p.000925: (b) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under subsection (a), an entity shall—
p.000925: (1) be an accredited entity that offers education to students in various health professions, which may include—
p.000925: (A) a teaching hospital;
p.000925: (B) a medical school;
p.000925: (C) a certified behavioral health clinic; or
p.000925: (D) any other health professions school, school of pub- lic health, or Cooperative Extension Program at institu-
p.000925: tions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in
...

p.001011: 1 or more public or nonprofit community based His- panic serving organizations, or public or nonprofit pri-
p.001011: vate institutions of higher education, including schools of nursing, whose enrollment of students has tradi-
p.001011: tionally included a significant number of Hispanic in- dividuals, the purposes of which will be to carry out a
p.001011: program—
p.001011: (I) to identify Hispanic students who are in- terested in a career in the health profession in- volved;
p.001011: and
p.001011:
p.001011:
p.001011:
p.001011: January 30, 2020
p.001011: 7 So in law. Probably should read ‘‘paragraph (2) or (5)’’.
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001011:
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p.001011: Sec. 736 PUBLIC HEALTH SERVICE ACT 1012
p.001011:
p.001011: (II) to facilitate the educational preparation of such students to enter the health professions school; and
p.001011: (ii) the school will make efforts to recruit Hispanic students, including students who have participated in the
p.001011: undergraduate or other matriculation program carried out under arrangements established by the school
p.001011: pursuant to clause (i)(II) and will assist His- panic students regarding the completion of the edu-
p.001011: cational requirements for a degree from the school.
p.001011: (4) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Subject to subsection (e), the conditions specified in this
p.001011: paragraph are that—
p.001011: (A) with respect to Native Americans, each of clauses
p.001011: (i) through (iv) of paragraph (1)(B) applies to the des- ignated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Native Americans; and
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p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit private institutions of higher education, including schools of nursing,
p.001011: whose enrollment of students has traditionally included a significant number of Native Americans, the
p.001011: purpose of which arrangement will be to carry out a program—
p.001011: (I) to identify Native American students, from the institutions of higher education referred to in clause (i),
p.001011: who are interested in health professions careers; and
p.001011: (II) to facilitate the educational preparation of such students to enter the designated health pro- fessions
p.001011: school; and
p.001011: (ii) the designated health professions school will make efforts to recruit Native American students, in-
p.001011: cluding students who have participated in the under- graduate program carried out under arrangements es-
p.001011: tablished by the school pursuant to clause (i) and will assist Native American students regarding the comple- tion of
p.001011: the educational requirements for a degree from the designated health professions school.
p.001011: (5) OTHER CENTERS OF EXCELLENCE.—The conditions speci- fied in this paragraph are—
p.001011: (A) with respect to other centers of excellence, the con- ditions described in clauses (i) through (iv) of
p.001011: paragraph (1)(B); and
p.001011: (B) that the health professions school involved has an enrollment of under-represented minorities above the na-
p.001011: tional average for such enrollments of health professions schools.
p.001011: (d) DESIGNATION AS CENTER OF EXCELLENCE.—
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001013: 1013
p.001013: PUBLIC HEALTH SERVICE ACT
p.001013: Sec. 736
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p.001013: January 30, 2020
p.001013: (1) IN GENERAL.—Any designated health professions school receiving a grant under subsection (a) and meeting the
p.001013: condi- tions described in paragraph (2) or (5) of subsection (c) shall, for purposes of this section, be
p.001013: designated by the Secretary as a Center of Excellence in Under-Represented Minority Health Professions
p.001013: Education.
p.001013: (2) HISPANIC CENTERS OF EXCELLENCE.—Any designated health professions school receiving a grant under subsection
p.001013: (a) and meeting the conditions described in subsection (c)(3) shall, for purposes of this section, be designated by the
p.001013: Secretary as a Hispanic Center of Excellence in Health Professions Edu- cation.
p.001013: (3) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Any des- ignated health professions school receiving a grant under
p.001013: sub- section (a) and meeting the conditions described in subsection (c)(4) shall, for purposes of this
p.001013: section, be designated by the Secretary as a Native American Center of Excellence in Health Professions Education.
p.001013: Any consortium receiving such a grant pursuant to subsection (e) shall, for purposes of this section, be so
p.001013: designated.
p.001013: (e) AUTHORITY REGARDING NATIVE AMERICAN CENTERS OF EX- CELLENCE.—With respect to meeting the conditions
p.001013: specified in subsection (c)(4), the Secretary may make a grant under subsection
p.001013: (a) to a designated health professions school that does not meet such conditions if—
p.001013: (1) the school has formed a consortium in accordance with subsection (d)(1); and
p.001013: (2) the schools of the consortium collectively meet such conditions, without regard to whether the
p.001013: schools individually meet such conditions.
p.001013: (f) DURATION OF GRANT.—The period during which payments are made under a grant under subsection (a) may
p.001013: not exceed 5 years. Such payments shall be subject to annual approval by the Secretary and to the
p.001013: availability of appropriations for the fiscal year involved to make the payments.
p.001013: (g) DEFINITIONS.—In this section:
p.001013: (1) DESIGNATED HEALTH PROFESSIONS SCHOOL.—
p.001013: (A) IN GENERAL.—The term ‘‘health professions school’’ means, except as provided in subparagraph (B), a school of
p.001013: medicine, a school of osteopathic medicine, a school of den- tistry, a school of pharmacy, or a graduate program in be-
p.001013: havioral or mental health.
p.001013: (B) EXCEPTION.—The definition established in sub- paragraph (A) shall not apply to the use of the term ‘‘des-
p.001013: ignated health professions school’’ for purposes of sub- section (c)(2).
p.001013: (2) PROGRAM OF EXCELLENCE.—The term ‘‘program of ex- cellence’’ means any program carried out by a
p.001013: designated health professions school with a grant made under subsection (a), if the program is for purposes
p.001013: for which the school involved is authorized in subsection (b) or (c) to expend the grant.
p.001013: (3) NATIVE AMERICANS.—The term ‘‘Native Americans’’ means American Indians, Alaskan Natives, Aleuts, and
p.001013: Native Hawaiians.
p.001013: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001013:
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p.001013: Sec. 736 PUBLIC HEALTH SERVICE ACT 1014
p.001013:
p.001013: (h) FORMULA FOR ALLOCATIONS.—
p.001013: (1) ALLOCATIONS.—Based on the amount appropriated under subsection (i) for a fiscal year, the
p.001013: following subpara- graphs shall apply as appropriate:
p.001013: (A) IN GENERAL.—If the amounts appropriated under subsection (i) for a fiscal year are $24,000,000 or less—
p.001013: (i) the Secretary shall make available $12,000,000 for grants under subsection (a) to health professions schools
p.001013: that meet the conditions described in sub- section (c)(2)(A); and
p.001013: (ii) and available after grants are made with funds under clause (i), the Secretary shall make avail-
p.001013: able—
p.001013: (I) 60 percent of such amount for grants under subsection (a) to health professions schools that
p.001013: meet the conditions described in paragraph
p.001013: (3) or (4) of subsection (c) (including meeting the conditions under subsection (e)); and
p.001013: (II) 40 percent of such amount for grants under subsection (a) to health professions schools that
p.001013: meet the conditions described in subsection (c)(5).
p.001013: (B) FUNDING IN EXCESS OF $24,000,000.—If amounts ap- propriated under subsection (i) for a fiscal year
p.001013: exceed
p.001013: $24,000,000 but are less than $30,000,000—
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p.001043: under subsection (a) for administrative expenses.
p.001043: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: PUBLIC HEALTH SERVICE ACT
p.001045: Sec. 755
p.001045:
p.001045: (B) TRAINING.—Not more than 10 percent of the indi- viduals receiving training with funds made available to an
p.001045: applicant under subsection (a) shall be trained as doctors of medicine or doctors of osteopathy.
p.001045: (C) LIMITATION.—An institution that receives a grant under this section shall use amounts received under
p.001045: such grant to supplement, not supplant, amounts made avail- able by such institution for activities of the type
p.001045: described in subsection (b)(1) in the fiscal year preceding the year for which the grant is received.
p.001045: (c) APPLICATIONS.—Applications submitted for assistance under this section shall—
p.001045: (1) be jointly submitted by at least two eligible applicants with the express purpose of assisting
p.001045: individuals in academic institutions in establishing long-term collaborative relation- ships with health care
p.001045: providers in rural areas; and
p.001045: (2) designate a rural health care agency or agencies for clinical treatment or training, including
p.001045: hospitals, community health centers, migrant health centers, rural health clinics, community behavioral and
p.001045: mental health centers, long-term care facilities, Native Hawaiian health centers, or facilities op- erated by the
p.001045: Indian Health Service or an Indian tribe or tribal organization or Indian organization under a contract with
p.001045: the Indian Health Service under the Indian Self-Determination Act.
p.001045: (d) DEFINITIONS.—For the purposes of this section, the term ‘‘rural’’ means geographic areas that are located
p.001045: outside of standard metropolitan statistical areas.
p.001045: SEC. 755. ø294e¿ ALLIED HEALTH AND OTHER DISCIPLINES.
p.001045: (a) IN GENERAL.—The Secretary may make grants or contracts under this section to help entities fund activities
p.001045: of the type de- scribed in subsection (b).
p.001045: (b) ACTIVITIES.—Activities of the type described in this sub- section include the following:
p.001045: (1) Assisting entities in meeting the costs associated with expanding or establishing programs that
p.001045: will increase the number of individuals trained in allied health professions. Pro- grams and activities funded
p.001045: under this paragraph may in- clude—
p.001045:
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p.001045: (A) those that expand enrollments in allied health pro- fessions with the greatest shortages or whose services
p.001045: are most needed by the elderly;
p.001045: (B) those that provide rapid transition training pro- grams in allied health fields to individuals who
p.001045: have bac- calaureate degrees in health-related sciences;
p.001045: (C) those that establish community-based allied health training programs that link academic centers to rural clin- ical
p.001045: settings;
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p.001053:
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p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
...

p.001085: January 30, 2020
p.001085: a recognized body or bodies or State agency, shall be deemed accredited for purposes of this title if the
p.001085: Secretary of Education finds, after consultation with the appropriate accreditation body or bodies, that there is
p.001085: reasonable as- surance that the program will meet the accreditation standards of such body or bodies
p.001085: prior to the beginning of the academic year following the normal graduation date of students of the first entering
p.001085: class in such a program.
p.001085: (7) NONPROFIT.—The term ‘‘nonprofit’’ as applied to any school, agency, organization, or institution means one
p.001085: which is a corporation or association, or is owned and operated by one or more corporations or
p.001085: associations, no part of the net earn- ings of which inures, or may lawfully inure, to the benefit of
p.001085: any private shareholder or individual.
p.001085: (8) STATE.—The term ‘‘State’’ means a State, the Common- wealth of Puerto Rico, the District of Columbia, the
p.001085: Common- wealth of the Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, or the Trust Territory
p.001085: of the Pacific Islands.
p.001085: (9) AMBULATORY SURGICAL CENTER.—The term ‘‘ambula- tory surgical center’’ has the meaning applicable to
p.001085: such term under title XVIII of the Social Security Act.
p.001085: (10) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001085: given such term under section 1861(aa)(4) of the Social Security Act.
p.001085: (11) HEALTH CARE FACILITY.—The term ‘‘health care facil- ity’’ means an Indian Health Service health
p.001085: center, a Native Hawaiian health center, a hospital, a Federally qualified health center, a rural
p.001085: health clinic, a nursing home, a home health agency, a hospice program, a public health clinic, a State
p.001085: or local department of public health, a skilled nursing fa- cility, an ambulatory surgical center, or any other
p.001085: facility des- ignated by the Secretary.
p.001085: (12) HOME HEALTH AGENCY.—The term ‘‘home health agen- cy’’ has the meaning given such term in section 1861(o) of the
p.001085: Social Security Act.
p.001085: (13) HOSPICE PROGRAM.—The term ‘‘hospice program’’ has the meaning given such term in section 1861(dd)(2)
p.001085: of the So- cial Security Act.
p.001085: (14) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given such term in section 1861(aa)(2) of
p.001085: the Social Security Act.
p.001085: (15) SKILLED NURSING FACILITY.—The term ‘‘skilled nurs- ing facility’’ has the meaning given
p.001085: such term in section 1819(a) of the Social Security Act.
p.001085: (16) ACCELERATED NURSING DEGREE PROGRAM.—The term ‘‘accelerated nursing degree program’’ means a program of edu-
p.001085: cation in professional nursing offered by an accredited school of nursing in which an individual holding
p.001085: a bachelors degree in another discipline receives a BSN or MSN degree in an ac- celerated time frame as
p.001085: determined by the accredited school of nursing.
p.001085: (17) BRIDGE OR DEGREE COMPLETION PROGRAM.—The term ‘‘bridge or degree completion program’’ means a program
p.001085: of
...

p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
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p.001089:
p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: 1091
p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
p.001091: Islander Nurses, the Native American Indian and Alas- kan Nurses Association, and the National Council of State
p.001091: Boards of Nursing, and other organizations determined appropriate by the Secretary.
p.001091: (c) REQUIRED INFORMATION AND CONDITIONS FOR AWARD RE-
p.001091: CIPIENTS.—
p.001091: (1) IN GENERAL.—Recipients of awards under this section may be required, where requested, to report to
p.001091: the Secretary concerning the annual admission, retention, and graduation rates for individuals from
p.001091: disadvantaged backgrounds and eth- nic and racial minorities in the school or schools involved in the
p.001091: projects.
p.001091: (2) FALLING RATES.—If any of the rates reported under paragraph (1) fall below the average of the two previous
p.001091: years, the grant or contract recipient shall provide the Secretary with plans for immediately improving such rates.
p.001091: (3) INELIGIBILITY.—A recipient described in paragraph (2) shall be ineligible for continued funding under
p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
p.001091:
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p.001091:
p.001091:
p.001091: January 30, 2020
p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
...

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p.001277: 1277
p.001277: PUBLIC HEALTH SERVICE ACT
p.001277: Sec. 1707A
p.001277:
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p.001277: January 30, 2020
p.001277: ice agencies shall submit to the Deputy Assistant Secretary a report summarizing the minority health
p.001277: activities of each of the respective agencies.
p.001277: (g) DEFINITION.—For purposes of this section:
p.001277: (1) The term ‘‘racial and ethnic minority group’’ means American Indians (including Alaska Natives,
p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
p.001277: Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administra-
p.001277: tion, and the Centers for Medicare & Medicaid Services.
...

p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
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p.001333:
p.001333: Sec. 1951 PUBLIC HEALTH SERVICE ACT 1334
p.001333:
p.001333: delegate to the States the primary responsibility for interpreting the governing provisions of this part.
p.001333: SEC. 1951. ø300x–61¿ SOLICITATION OF VIEWS OF CERTAIN ENTITIES.
p.001333: In carrying out this part, the Secretary, as appropriate, shall solicit the views of the States and other
p.001333: appropriate entities.
p.001333: SEC. 1952. 17 ø300x–62¿ AVAILABILITY TO STATES OF GRANT PAYMENTS.
p.001333: Any amounts paid to a State for a fiscal year under section 1911 or 1921 shall be available for obligation
p.001333: and expenditure until the end of the fiscal year following the fiscal year for which the amounts were paid.
p.001333: SEC. 1953. ø300x–63¿ CONTINUATION OF CERTAIN PROGRAMS.
p.001333: (a) IN GENERAL.—Of the amount allotted to the State of Ha- waii under section 1911, and the amount
p.001333: allotted to such State under section 1921, an amount equal to the proportion of Native Hawaiians residing
p.001333: in the State to the total population of the State shall be available, respectively, for carrying out the
p.001333: program in- volved for Native Hawaiians.
p.001333: (b) EXPENDITURE OF AMOUNTS.—The amount made available under subsection (a) may be expended only through
p.001333: contracts en- tered into by the State of Hawaii with public and private nonprofit organizations to enable such
p.001333: organizations to plan, conduct, and administer comprehensive substance use disorder and treatment programs
p.001333: for the benefit of Native Hawaiians. In entering into con- tracts under this section, the State of Hawaii shall give
p.001333: preference to Native Hawaiian organizations and Native Hawaiian health cen- ters.
p.001333: (c) DEFINITIONS.—For the purposes of this subsection 18, the terms ‘‘Native Hawaiian’’, ‘‘Native Hawaiian
p.001333: organization’’, and ‘‘Native Hawaiian health center’’ have the meaning given such terms in section 2308 of
p.001333: subtitle D of title II of the Anti-Drug Abuse Act of 1988.
p.001333: SEC. 1954. ø300x–64¿ DEFINITIONS.
p.001333: (a) DEFINITIONS FOR SUBPART III.—For purposes of this sub- part:
p.001333: (1) The term ‘‘program involved’’ means the program of grants established in section 1911 or 1921, or
p.001333: both, as indi- cated by whether the State involved is receiving or is applying to receive a grant under section 1911
p.001333: or 1921, or both.
p.001333: (2)(A) The term ‘‘funding agreement’’, with respect to a grant under section 1911, has the meaning given such
p.001333: term in section 1919.
p.001333: (B) The term ‘‘funding agreement’’, with respect to a grant under section 1921, has the meaning given such term
p.001333: in sec- tion 1934.
p.001333: (b) DEFINITIONS FOR PART B.—For purposes of this part:
p.001333: (1) The term ‘‘Comptroller General’’ means the Comptroller General of the United States.
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 17 Section 1952 appears according to the probable intent of the Congress. Section 3403(b) of Public Law
p.001333: 106–310 (114 Stat. 1220) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1952 ‘‘is amended to read as follows:’’.
p.001333: 18 So in law. See section 203 of Public Law 102–321 (106 Stat. 409). Probably should be ‘‘sec- tion’’.
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
p.001333:
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p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
...

p.001527: trans- mission of the disease, including measures for the preven- tion and treatment of opportunistic infections, and
p.001527: includ- ing (as applicable to the type of health professional in- volved), prenatal and other
p.001527: gynecological care for women with HIV/AIDS;
p.001527: (B) to train the faculty of schools of, and graduate de- partments or programs of, medicine, nursing, osteopathic
p.001527: medicine, dentistry, public health, allied health, and men- tal health practice to teach health professions
p.001527: students to provide for the health care needs of individuals with HIV/ AIDS;
p.001527: (C) to develop and disseminate curricula and resource materials relating to the care and treatment of individuals with
p.001527: such disease and the prevention of the disease among individuals who are at risk of contracting the disease; and
p.001527: (D) to develop protocols for the medical care of women with HIV/AIDS, including prenatal and other gynecological care
p.001527: for such women.
p.001527: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.001527: preference to qualified projects which will—
p.001527: (A) train, or result in the training of, health profes- sionals who will provide treatment for minority
p.001527: individuals and Native Americans with HIV/AIDS and other individ- uals who are at high risk of contracting such
p.001527: disease;
p.001527: (B) train, or result in the training of, minority health professionals and minority allied health
p.001527: professionals to provide treatment for individuals with such disease; and
p.001527: (C) train or result in the training of health profes- sionals and allied health professionals to provide
p.001527: treat- ment for hepatitis B or C co-infected individuals.
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001527:
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p.001527: Sec. 2692 PUBLIC HEALTH SERVICE ACT 1528
p.001527:
p.001527: (3) APPLICATION.—No grant or contract may be made under paragraph (1) unless an application is
p.001527: submitted to the Secretary in such form, at such time, and containing such in- formation, as the Secretary
p.001527: may prescribe.
p.001527: (b) DENTAL SCHOOLS.—
p.001527: (1) IN GENERAL.—
p.001527: (A) GRANTS.—The Secretary may make grants to den- tal schools and programs described in subparagraph (B) to assist
p.001527: such schools and programs with respect to oral health care to patients with HIV/AIDS.
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p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
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p.001601: 1601
p.001601: PUBLIC HEALTH SERVICE ACT
p.001601: Sec. 2744
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p.001601: January 30, 2020
p.001601: (i) a model act described in subsection (c)(1),
p.001601: (ii) a qualified high risk pool described in sub- section (c)(2), or
p.001601: (iii) a mechanism described in subsection (c)(3).
p.001601: (2) PERMISSIBLE FORMS OF MECHANISMS.—A private or public individual health insurance mechanism
p.001601: (such as a health insurance coverage pool or programs, mandatory group conversion policies, guaranteed
p.001601: issue of one or more plans of individual health insurance coverage, or open enrollment by one or more
p.001601: health insurance issuers), or combination of such mechanisms, that is designed to provide access to health bene-
p.001601: fits for individuals in the individual market in the State in ac- cordance with this section may constitute an
p.001601: acceptable alter- native mechanism.
p.001601: (b) APPLICATION OF ACCEPTABLE ALTERNATIVE MECHANISMS.—
p.001601: (1) PRESUMPTION.—
p.001601: (A) IN GENERAL.—Subject to the succeeding provisions of this subsection, a State is presumed to be implementing an
p.001601: acceptable alternative mechanism in accordance with this section as of July 1, 1997, if, by not later
p.001601: than April 1, 1997, the chief executive officer of a State—
p.001601: (i) notifies the Secretary that the State has en- acted or intends to enact (by not later than January
p.001601: 1, 1998, or July 1, 1998, in the case of a State de- scribed in subparagraph (B)(ii)) any necessary
p.001601: legisla- tion to provide for the implementation of a mechanism reasonably designed to be an acceptable
p.001601: alternative mechanism as of January 1, 1998, (or, in the case of a State described in subparagraph
p.001601: (B)(ii), July 1, 1998); and
p.001601: (ii) provides the Secretary with such information as the Secretary may require to review the mechanism and its
p.001601: implementation (or proposed implementation) under this subsection.
p.001601: (B) DELAY PERMITTED FOR CERTAIN STATES.—
p.001601: (i) EFFECT OF DELAY.—In the case of a State de- scribed in clause (ii) that provides notice under sub-
p.001601: paragraph (A)(i), for the presumption to continue on and after July 1, 1998, the chief executive officer
p.001601: of the State by April 1, 1998—
p.001601: (I) must notify the Secretary that the State has enacted any necessary legislation to provide for the
p.001601: implementation of a mechanism reason- ably designed to be an acceptable alternative mechanism as of
p.001601: July 1, 1998; and
p.001601: (II) must provide the Secretary with such in- formation as the Secretary may require to review the
p.001601: mechanism and its implementation (or pro- posed implementation) under this subsection.
p.001601: (ii) STATES DESCRIBED.—A State described in this clause is a State that has a legislature that does not
p.001601: meet within the 12-month period beginning on the date of enactment of this Act.
p.001601: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001601:
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p.001601:
p.001601: Sec. 2744 PUBLIC HEALTH SERVICE ACT 1602
p.001601: (C) CONTINUED APPLICATION.—In order for a mecha- nism to continue to be presumed to be an acceptable alter-
p.001601: native mechanism, the State shall provide the Secretary every 3 years with information described in subparagraph
p.001601: (A)(ii) or (B)(i)(II) (as the case may be).
p.001601: (2) NOTICE.—If the Secretary finds, after review of infor- mation provided under paragraph (1) and in
p.001601: consultation with the chief executive officer of the State and the insurance com- missioner or chief insurance
p.001601: regulatory official of the State, that such a mechanism is not an acceptable alternative mecha- nism or is not
p.001601: (or no longer) being implemented, the Sec- retary—
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p.001601: January 30, 2020
p.001601: (A) shall notify the State of—
p.001601: (i) such preliminary determination, and
p.001601: (ii) the consequences under paragraph (3) of a fail- ure to implement such a mechanism; and
p.001601: (B) shall permit the State a reasonable opportunity in which to modify the mechanism (or to adopt another mech- anism)
p.001601: in a manner so that may be an acceptable alter- native mechanism or to provide for implementation of such a
p.001601: mechanism.
p.001601: (3) FINAL DETERMINATION.—If, after providing notice and opportunity under paragraph (2), the Secretary
p.001601: finds that the mechanism is not an acceptable alternative mechanism or the State is not implementing such
p.001601: a mechanism, the Secretary shall notify the State that the State is no longer considered to be implementing an
p.001601: acceptable alternative mechanism and that the requirements of section 2741 shall apply to health in- surance
p.001601: coverage offered in the individual market in the State, effective as of a date specified in the notice.
p.001601: (4) LIMITATION ON SECRETARIAL AUTHORITY.—The Sec- retary shall not make a determination under paragraph
p.001601: (2) or
p.001601: (3) on any basis other than the basis that a mechanism is not an acceptable alternative mechanism or is not
p.001601: being imple- mented.
p.001601: (5) FUTURE ADOPTION OF MECHANISMS.—If a State, after January 1, 1997, submits the notice and information
p.001601: described in paragraph (1), unless the Secretary makes a finding de- scribed in paragraph (3) within the
p.001601: 90-day period beginning on the date of submission of the notice and information, the mech- anism shall be
p.001601: considered to be an acceptable alternative mechanism for purposes of this section, effective 90 days after
p.001601: the end of such period, subject to the second sentence of para- graph (1).
p.001601: (c) PROVISION RELATED TO RISK.—
p.001601: (1) ADOPTION OF NAIC MODELS.—The model act referred to in subsection (a)(1)(D)(i) is the Small Employer and
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p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
p.001275: (1) RECOMMENDATIONS REGARDING LANGUAGE.—
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001275:
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p.001275:
p.001275: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1276
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p.001275: January 30, 2020
p.001275:
p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
p.001275: the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other
p.001275: appro- priate departmental entities regarding recommendations for carrying out activities under subsection (b)(9).
p.001275: (B) HEALTH PROFESSIONS EDUCATION REGARDING HEALTH DISPARITIES.—The Deputy Assistant Secretary
p.001275: shall carry out the duties under subsection (b)(10) in col- laboration with appropriate personnel of the
p.001275: Department of Health and Human Services, other Federal agencies, and other offices, centers, and institutions,
p.001275: as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and
p.001275: Education Act of 2000.
p.001275: (2) EQUITABLE ALLOCATION REGARDING ACTIVITIES.—In car- rying out subsection (b), the Secretary shall ensure
p.001275: that serv- ices provided under such subsection are equitably allocated among all groups served under this
p.001275: section by the Secretary.
p.001275: (3) CULTURAL COMPETENCY OF SERVICES.—The Secretary shall ensure that information and services provided
p.001275: pursuant to subsection (b) are provided in the language, educational, and cultural context that is most appropriate for
p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
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p.000017: the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device—
p.000017: (1) to notify local emergency response personnel or other appropriate entities of the most recent placement of
p.000017: the device within a reasonable period of time after the device was placed;
p.000017: (2) to properly maintain and test the device; or
p.000017: (3) to provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee
p.000017: or agent was the person who used the device on the victim, except that such requirement of training does not apply if—
p.000017: (A) the employee or agent was not an employee or agent who would have been reasonably expected to use the
p.000017: device; or
p.000017: (B) the period of time elapsing between the engage- ment of the person as an employee or agent and the occur-
p.000017: rence of the harm (or between the acquisition of the device and the occurrence of the harm, in any case in
p.000017: which the device was acquired after such engagement of the person) was not a reasonably sufficient period in
p.000017: which to provide the training.
p.000017: (b) INAPPLICABILITY OF IMMUNITY.—Immunity under subsection
p.000017: (a) does not apply to a person if—
p.000017: (1) the harm involved was caused by willful or criminal misconduct, gross negligence, reckless misconduct,
p.000017: or a con- scious, flagrant indifference to the rights or safety of the victim who was harmed;
p.000017: (2) the person is a licensed or certified health professional who used the automated external defibrillator device
p.000017: while act- ing within the scope of the license or certification of the profes-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: Sec. 248 PUBLIC HEALTH SERVICE ACT 58
p.000017:
p.000017: sional and within the scope of the employment or agency of the professional;
p.000017: (3) the person is a hospital, clinic, or other entity whose purpose is providing health care directly
p.000017: to patients, and the harm was caused by an employee or agent of the entity who used the device while
p.000017: acting within the scope of the employ- ment or agency of the employee or agent; or
p.000017: (4) the person is an acquirer of the device who leased the device to a health care entity (or who
p.000017: otherwise provided the device to such entity for compensation without selling the de- vice to the
p.000017: entity), and the harm was caused by an employee or agent of the entity who used the device while acting within
p.000017: the scope of the employment or agency of the employee or agent.
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p.000221: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 222
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p.000221: January 30, 2020
p.000221:
p.000221: metic Act, such act or omission shall not constitute ‘‘willful misconduct’’ for purposes of subsection (d) if—
p.000221: (i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act
p.000221: or omission; or
p.000221: (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a
p.000221: covered remedy.
p.000221: Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement
p.000221: action.
p.000221: (B) DEFINITIONS.—For purposes of this paragraph, the following terms have the following meanings:
p.000221: (i) ENFORCEMENT ACTION.—The term ‘‘enforcement action’’ means a criminal prosecution, an action seek- ing an
p.000221: injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall
p.000221: of a product because voluntary recall was re- fused, a proceeding to compel repair or replacement of a product,
p.000221: a termination of an exemption under sec- tion 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic
p.000221: Act, a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or
p.000221: agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of
p.000221: such Act, or a suspension or withdrawal, based on willful misconduct, of an approval or clear- ance under
p.000221: chapter V of such Act or of a licensure under section 351 of this Act.
p.000221: (ii) COVERED REMEDY.—The term ‘‘covered rem- edy’’ means an outcome—
p.000221: (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product
p.000221: recall, a repair or replacement of a prod- uct, a termination of an exemption under section 505(i) or
p.000221: 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment, an investigator dis- qualification, a
p.000221: revocation of an authorization under section 564 of such Act, or a suspension or withdrawal of an
p.000221: approval or clearance under chapter 5 of such Act or of a licensure under sec- tion 351 of this Act;
p.000221: and
p.000221: (II) that results from a final determination by a court or from a final agency action.
p.000221: (iii) FINAL.—The terms ‘‘final’’ and ‘‘finally’’—
p.000221: (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court
p.000221: determination, mean a judgment from which an appeal of right cannot be taken or a vol- untary or stipulated
p.000221: dismissal; and
p.000221: (II) with respect to an agency action, or to a final resolution of an enforcement action that is an
p.000221: agency action, mean an order that is not sub- ject to further review within the agency and that has not
p.000221: been reversed, vacated, enjoined, or other-
p.000221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000223: 223
p.000223: PUBLIC HEALTH SERVICE ACT
p.000223: Sec. 319F–3
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p.000223: January 30, 2020
p.000223: (C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or
p.000223: se- rious physical injury.
p.000223: (4) VERIFICATION, CERTIFICATION, AND MEDICAL RECORDS.—
p.000223: (A) IN GENERAL.—In an action under subsection (d), the plaintiff shall verify the complaint in the manner stat-
p.000223: ed in subparagraph (B) and shall file with the complaint the materials described in subparagraph (C). A
p.000223: complaint that does not substantially comply with subparagraphs (B) and (C) shall not be accepted for filing
p.000223: and shall not stop the running of the statute of limitations.
p.000223: (B) VERIFICATION REQUIREMENT.—
p.000223: (i) IN GENERAL.—The complaint shall include a verification, made by affidavit of the plaintiff under oath,
p.000223: stating that the pleading is true to the knowl- edge of the deponent, except as to matters specifically
p.000223: identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to
p.000223: be true.
p.000223: (ii) IDENTIFICATION OF MATTERS ALLEGED UPON IN- FORMATION AND BELIEF.—Any matter that is not spe- cifically
p.000223: identified as being alleged upon the informa- tion and belief of the plaintiff, shall be regarded for all
p.000223: purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
p.000223: (C) MATERIALS REQUIRED.—In an action under sub- section (d), the plaintiff shall file with the complaint—
p.000223: (i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed,
p.000223: certifying, and explaining the basis for such physi- cian’s belief, that such person suffered the serious
p.000223: physical injury or death alleged in the complaint and that such injury or death was proximately caused
p.000223: by the administration or use of a covered counter- measure; and
p.000223: (ii) certified medical records documenting such in- jury or death and such proximate causal connection.
p.000223: (5) THREE-JUDGE COURT.—Any action under subsection (d) shall be assigned initially to a panel of three judges.
p.000223: Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss,
p.000223: motions for summary judg- ment, and matters related thereto. If such panel has denied such motions, or if
p.000223: the time for filing such motions has expired, such panel shall refer the action to the chief judge for
p.000223: assign- ment for further proceedings, including any trial. Section 1253 of title 28, United States Code, and paragraph
p.000223: (3) of subsection
p.000223: (b) of section 2284 of title 28, United States Code, shall not apply to actions under subsection (d).
p.000223: (6) CIVIL DISCOVERY.—
p.000223: (A) TIMING.—In an action under subsection (d), no dis- covery shall be allowed—
p.000223: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000223:
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p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
p.000401: Subtitle C of such title (section 221 et seq.; 116 Stat. 657) relates to interagency coordination of the two
p.000401: programs.
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p.000403: PUBLIC HEALTH SERVICE ACT
p.000403: Sec. 351A
p.000403:
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p.000403: (B) proper laboratory facilities to contain and dispose of such agents and toxins;
p.000403: (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and
p.000403: toxins for use in domestic or international terrorism or for any other criminal purpose;
p.000403: (3) the establishment of procedures to protect the public safety in the event of a transfer or
p.000403: potential transfer of such an agent or toxin in violation of the safety procedures estab- lished under
p.000403: paragraph (1) or the safeguard and security meas- ures established under paragraph (2); and
p.000403: (4) appropriate availability of biological agents and toxins for research, education, and other legitimate
p.000403: purposes.
p.000403: (c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—The Secretary shall by regulation provide for the
p.000403: establishment and en- forcement of standards and procedures governing the possession and use of listed
p.000403: agents and toxins, including the provisions de- scribed in paragraphs (1) through (4) of subsection (b),
p.000403: in order to protect the public health and safety.
p.000403: (d) REGISTRATION; IDENTIFICATION; DATABASE.—
p.000403: (1) REGISTRATION.—Regulations under subsections (b) and
p.000403: (c) shall require registration with the Secretary of the posses- sion, use, and transfer of listed agents and
p.000403: toxins, and shall in- clude provisions to ensure that persons seeking to register under such regulations
p.000403: have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in ac-
p.000403: cordance with subsection (e)(6).
p.000403: (2) IDENTIFICATION; DATABASE.—Regulations under sub- sections (b) and (c) shall require that
p.000403: registration include (if available to the person registering) information regarding the characterization of
...

p.000405:
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p.000405: If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.
p.000405: (5) EXPEDITED REVIEW.—Regulations under subsections (b) and (c) shall provide for a procedure through which,
p.000405: upon re- quest to the Secretary by a registered person who submits names and other identifying
p.000405: information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by
p.000405: the Secretary—
p.000405: (A) request the Attorney General to expedite the proc- ess of identification under paragraph (3)(A) and
p.000405: notifica- tion of the Secretary under paragraph (3)(C); and
p.000405: (B) expedite the notification of the registered person by the Secretary under paragraph (4).
p.000405: (6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
p.000405: (A) INDIVIDUALS.—Regulations under subsections (b) and (c) shall provide that an individual who seeks to
p.000405: reg- ister under either of such subsections is subject to the same processes described in paragraphs (2)
p.000405: through (4) as apply to names and other identifying information sub- mitted to the Attorney General under
p.000405: paragraph (2)(B). Paragraph (5) does not apply for purposes of this subpara- graph.
p.000405: (B) OTHER PERSONS.—Regulations under subsections
p.000405: (b) and (c) shall provide that, in determining whether to deny or revoke registration by a person other than
p.000405: an indi- vidual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal,
p.000405: immigra- tion, national security, and other electronic databases available to the Federal Government,
p.000405: as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the
p.000405: individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law
p.000405: enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied
p.000405: to persons, including individuals). Such regulations shall provide that a person who seeks to register under
p.000405: either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply
p.000405: to names and other identifying information sub- mitted to the Attorney General under paragraph (2)(B).
p.000405: Paragraph (5) does not apply for purposes of this subpara- graph. The Secretary may exempt Federal, State, or
p.000405: local governmental agencies from the requirements of this sub- paragraph.
p.000405: (7) REVIEW.—
p.000405: (A) ADMINISTRATIVE REVIEW.—
p.000405: (i) IN GENERAL.—Regulations under subsections
p.000405: (b) and (c) shall provide for an opportunity for a re- view by the Secretary—
p.000405: (I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual
p.000405: access to listed agents and toxins; and
p.000405: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000409: facility of the reg- istered person. Upon receipt of such notification and a finding by the Secretary
p.000409: that the release poses a threat to public health or safety, the Secretary shall take appropriate action
p.000409: to notify rel- evant State and local public health authorities, other relevant Fed- eral authorities, and, if
p.000409: necessary, other appropriate persons (in- cluding the public). If the released listed agent or toxin is an over-
p.000409: lap agent or toxin (as defined in subsection (l)), the Secretary shall promptly notify the Secretary of
p.000409: Agriculture upon notification by the registered person.
p.000409: (k) REPORTS.—
p.000409: (1) IN GENERAL.—The Secretary shall report to the Con- gress annually on the number and nature of
p.000409: notifications re- ceived under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to
p.000409: releases).
p.000409: (2) IMPLEMENTATION OF RECOMMENDATIONS OF THE FED- ERAL EXPERTS SECURITY ADVISORY PANEL AND THE FAST
p.000409: TRACK ACTION COMMITTEE ON SELECT AGENT REGULATIONS.—
p.000409: (A) IN GENERAL.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Pre-
p.000409: paredness and Advancing Innovation Act of 2019, the Sec- retary shall report to the congressional committees of
p.000409: ju- risdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel
p.000409: concerning the select agent program.
p.000409:
p.000409:
p.000409:
p.000409:
p.000409:
p.000409: January 30, 2020
p.000409: 61 Section 175b of title 18, United States Code, establishes criminal penalties relating to bio- logical
p.000409: agents or toxins that are listed as select agents in Appendix A of part 72 of title 42, Code of
p.000409: Federal Regulations, pursuant to section 351A above, and are not exempted under sub- section (h) of section 72.6,
p.000409: or Appendix A of part 72, of title 42, Code of Federal Regulations.
p.000409: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000409:
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p.000411: PUBLIC HEALTH SERVICE ACT
p.000411: Sec. 353
p.000411:
p.000411: (B) CONTINUED UPDATES.—The Secretary shall report to the congressional committees of jurisdiction
p.000411: annually following the submission of the report under subparagraph
p.000411: (A) until the recommendations described in such subpara- graph are fully implemented, or a justification is
p.000411: provided for the delay in, or lack of, implementation.
p.000411: (l) DEFINITIONS.—For purposes of this section:
p.000411: (1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the meanings given such terms in section
p.000411: 178 of title 18, United States Code.
p.000411: (2) The term ‘‘listed agents and toxins’’ means biological agents and toxins listed pursuant to subsection
p.000411: (a)(1).
p.000411: (3) The term ‘‘listed agents or toxins’’ means biological agents or toxins listed pursuant to subsection
p.000411: (a)(1).
p.000411: (4) The term ‘‘overlap agents and toxins’’ means biological agents and toxins that—
p.000411: (A) are listed pursuant to subsection (a)(1); and
...

p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
p.000501: (ii) the entity will identify children who may be eli- gible for medical assistance under a State program under
p.000501: title XIX or XXI of the Social Security Act.
p.000501: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision
...

p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
...

p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.000585: participating in their community.
p.000585: (b) REPORT ON THE HEALTH AND WELL-BEING OF INDIVIDUALS WITH AUTISM SPECTRUM DISORDER ACROSS THEIR
p.000585: LIFESPAN.—
p.000585: (1) IN GENERAL.—Not later than 2 years after the date of enactment of the Autism CARES Act of 2019,
p.000585: the Secretary shall prepare and submit, to the Committee on Health, Edu- cation, Labor, and Pensions of
p.000585: the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning
p.000585: the health and well-being of individuals with autism spectrum disorder.
p.000585: (2) CONTENTS.—The report submitted under paragraph (1) shall contain—
p.000585: (A) demographic factors associated with the health and well-being of individuals with autism spectrum dis-
p.000585: order;
p.000585: (B) an overview of policies and programs relevant to the health and well-being of individuals with autism spec-
p.000585: trum disorder, including an identification of existing Fed- eral laws, regulations, policies, research, and
p.000585: programs;
p.000585: (C) recommendations on establishing best practices guidelines to ensure interdisciplinary coordination between all
p.000585: relevant service providers receiving Federal funding;
p.000585: (D) comprehensive approaches to improving health outcomes and well-being for individuals with autism spec-
p.000585: trum disorder, including—
p.000585: (i) community-based behavioral supports and interventions;
p.000585: (ii) nutrition, recreational, and social activities;
p.000585: and
p.000585: (iii) personal safety services related to public safe-
p.000585:
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p.000585: ty agencies or the criminal justice system for such in- dividuals; and
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000587: PUBLIC HEALTH SERVICE ACT
p.000587: Sec. 399HH
p.000587:
p.000587: (E) recommendations that seek to improve health out- comes for such individuals, including across their lifespan, by
p.000587: addressing—
p.000587: (i) screening and diagnosis of children and adults;
p.000587: (ii) behavioral and other therapeutic approaches;
p.000587: (iii) primary and preventative care;
p.000587: (iv) communication challenges;
p.000587: (v) aggression, self-injury, elopement, and other behavioral issues;
p.000587: (vi) emergency room visits and acute care hos- pitalization;
p.000587: (vii) treatment for co-occurring physical and men- tal health conditions;
p.000587: (viii) premature mortality;
p.000587: (ix) medical practitioner training; and
p.000587: (x) caregiver mental health.
p.000587: SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000587: (a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RE- SEARCH PROGRAM.—To carry out section 399AA, there is
p.000587: authorized to be appropriated $23,100,000 for each of fiscal years 2020 through 2024.
p.000587: (b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVEN- TION.—To carry out section 399BB, there is authorized
...

p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
p.000813: (3) The term ‘‘valuable consideration’’ does not include rea- sonable payments associated with the transportation,
p.000813: implan- tation, processing, preservation, quality control, or storage of human fetal tissue.
p.000813: SEC. 498C. ø289g–3¿ BREAST IMPLANT RESEARCH.
p.000813: (a) IN GENERAL.—The Director of NIH may conduct or support research to examine the long-term health implications
p.000813: of silicone
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000815: PUBLIC HEALTH SERVICE ACT
p.000815: Sec. 498D
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p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
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p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
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p.000893: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000893: $4,269,000 for each of fiscal years 2018 through 2022.
p.000893: øSection 520H was repealed by section 9017 of Public Law 114–255.¿
p.000893: SEC. 520I. ø290bb–40¿ GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS MENTAL ILLNESS AND CO-OCCURRING
p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
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p.000899: including assistance with se- lection and implementation of evidence-based interventions and frameworks
p.000899: to prevent suicide.
p.000899: (c) DURATION.—A grant under this section shall be for a period of not more than 5 years.
p.000899: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $30,000,000
p.000899: for the pe- riod of fiscal years 2018 through 2022.
p.000899: SEC. 520M. ø290bb–44¿ ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
p.000899: (D) patient and family satisfaction with program par- ticipation; and
p.000899: (2) provide appropriate information, training, and technical assistance to grant recipients under this section
p.000899: to help such
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: Sec. 521 PUBLIC HEALTH SERVICE ACT 900
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p.000899: recipients to establish, maintain, or expand their assertive community treatment programs.
p.000899: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.000899: (1) IN GENERAL.—To carry out this section, there is author- ized to be appropriated $5,000,000 for the period of fiscal
p.000899: years 2018 through 2022.
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p.000905: payments under subsection (b)(1), the Secretary shall provide to the State an oppor- tunity for a hearing.
p.000905: (d) RULE OF CONSTRUCTION.—Notwithstanding any other pro- vision of this part, a State receiving payments
p.000905: under section 521 may not, with respect to any agreements required to be contained in the application
p.000905: submitted under section 529, be considered to be in violation of any such agreements by reason of the fact
p.000905: that the State, in the regular course of providing services under section 522(b) to eligible homeless
p.000905: individuals, incidentally provides serv- ices to homeless individuals who are not eligible homeless individ- uals.
p.000905: SEC. 532. ø290cc–32¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.000905: (a) IN GENERAL.—
p.000905: (1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in
p.000905: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.000905: payments received by the State under section 521.
p.000905: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
p.000905: amount in an amount greater than the amount the person is authorized to receive.
p.000905: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.000905: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.000905: for not more than 5 years, or both.
p.000905: SEC. 533. ø290cc–33¿ NONDISCRIMINATION.
p.000905: (a) IN GENERAL.—
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000907: PUBLIC HEALTH SERVICE ACT
p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.000907: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.000907: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.000907: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.000907: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section
p.000907: 521 shall be considered to be programs and activities receiving Federal fi- nancial assistance.
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p.000909: good cause therefor, including the need to avert a substan- tial risk of death or serious bodily harm. In assessing
p.000909: good cause the court shall weigh the public interest and the need for disclosure against the injury to the
p.000909: patient, to the physician-patient relationship, and to the treatment serv- ices. Upon the granting of such
p.000909: order, the court, in deter-
p.000909: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: PUBLIC HEALTH SERVICE ACT
p.000911: Sec. 543A
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p.000911: January 30, 2020
p.000911: mining the extent to which any disclosure of all or any part of any record is necessary, shall impose
p.000911: appropriate safeguards against unauthorized disclosure.
p.000911: (c) USE OF RECORDS IN CRIMINAL PROCEEDINGS.—Except as au- thorized by a court order granted under
p.000911: subsection (b)(2)(C), no record referred to in subsection (a) may be used to initiate or sub- stantiate any criminal
p.000911: charges against a patient or to conduct any investigation of a patient.
p.000911: (d) APPLICATION.—The prohibitions of this section continue to apply to records concerning any individual who has
p.000911: been a patient, irrespective of whether or when such individual ceases to be a pa- tient.
p.000911: (e) NONAPPLICABILITY.—The prohibitions of this section do not apply to any interchange of records—
p.000911: (1) within the Uniformed Services or within those compo- nents of the Department of Veterans Affairs furnishing
p.000911: health care to veterans; or
p.000911: (2) between such components and the Uniformed Services. The prohibitions of this section do not apply to the reporting
p.000911: under State law of incidents of suspected child abuse and neglect to the appropriate State or local
p.000911: authorities.
p.000911: (f) PENALTIES.—Any person who violates any provision of this section or any regulation issued pursuant to
p.000911: this section shall be fined in accordance with title 18, United States Code.
p.000911: (g) REGULATIONS.—Except as provided in subsection (h), the Secretary shall prescribe regulations to carry
p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
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p.000921: Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (ii) submits to the Secretary a certification by the at- torney general of the State that the attorney general
p.000921: has—
p.000921: (I) reviewed any applicable civil liability protec- tion law to determine the applicability of the law with
p.000921: respect to first responders, health care professionals, family members, and other individuals who—
p.000921: (aa) have received appropriate training in ad- ministering a drug or device approved or cleared under the
p.000921: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (bb) may administer a drug or device ap- proved or cleared under the Federal Food, Drug, and
p.000921: Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (II) concluded that the law described in subclause
p.000921: (I) provides adequate civil liability protection applica- ble to such persons;
p.000921: (B) has a process for enrollment in services and bene- fits necessary by criminal justice agencies to initiate
p.000921: or continue treatment in the community, under which an in- dividual who is incarcerated may, while
p.000921: incarcerated, en- roll in services and benefits that are necessary for the indi- vidual to continue treatment upon
p.000921: release from incarcer- ation;
p.000921: (C) ensures the capability of data sharing with other States, where applicable, such as by making data
p.000921: available to a prescription monitoring hub;
p.000921: (D) ensures that data recorded in the prescription drug monitoring program database of the State are
p.000921: regu- larly updated, to the extent possible;
p.000921: (E) ensures that the prescription drug monitoring pro- gram of the State notifies prescribers and dispensers of
p.000921: schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients
p.000921: is sus- pected; and
p.000921: (F) has in effect one or more statutes or implements policies that maximize use of prescription drug
p.000921: monitoring programs by individuals authorized by the State to pre- scribe schedule II, III, or IV controlled
p.000921: substances.
p.000921: (6) EVALUATION.—In conducting an evaluation of the pro- gram under this section pursuant to section 701
p.000921: of the Com- prehensive Addiction and Recovery Act of 2016, with respect to a State, the Secretary shall report on
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p.001125: pursu- ant to, a patient safety evaluation system.
p.001125: (B) CLARIFICATION.—
p.001125: (i) Information described in subparagraph (A) does not include a patient’s medical record, billing and dis-
p.001125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001127: PUBLIC HEALTH SERVICE ACT
p.001127: Sec. 922
p.001127:
p.001127: charge information, or any other original patient or provider record.
p.001127: (ii) Information described in subparagraph (A) does not include information that is collected, main-
p.001127: tained, or developed separately, or exists separately, from a patient safety evaluation system. Such sepa-
p.001127: rate information or a copy thereof reported to a pa- tient safety organization shall not by reason of
p.001127: its re- porting be considered patient safety work product.
p.001127: (iii) Nothing in this part shall be construed to limit—
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p.001127: January 30, 2020
p.001127: (I) the discovery of or admissibility of informa- tion described in this subparagraph in a criminal, civil, or
p.001127: administrative proceeding;
p.001127: (II) the reporting of information described in this subparagraph to a Federal, State, or local
p.001127: governmental agency for public health surveil- lance, investigation, or other public health pur- poses
p.001127: or health oversight purposes; or
p.001127: (III) a provider’s recordkeeping obligation with respect to information described in this sub- paragraph
p.001127: under Federal, State, or local law.
p.001127: (8) PROVIDER.—The term ‘‘provider’’ means—
p.001127: (A) an individual or entity licensed or otherwise au- thorized under State law to provide health care
p.001127: services, including—
p.001127: (i) a hospital, nursing facility, comprehensive out- patient rehabilitation facility, home health agency,
p.001127: hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care
p.001127: practitioner’s office, long term care facility, behavior health residential treatment facility, clinical
p.001127: labora- tory, or health center; or
p.001127: (ii) a physician, physician assistant, nurse practi- tioner, clinical nurse specialist, certified
p.001127: registered nurse anesthetist, certified nurse midwife, psycholo- gist, certified social worker, registered
p.001127: dietitian or nu- trition professional, physical or occupational therapist, pharmacist, or other individual
p.001127: health care practi- tioner; or
p.001127: (B) any other individual or entity specified in regula- tions promulgated by the Secretary.
p.001127: SEC. 922. ø299b–22¿ PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
p.001127: (a) PRIVILEGE.—Notwithstanding any other provision of Fed- eral, State, or local law, and subject to subsection
p.001127: (c), patient safety work product shall be privileged and shall not be—
p.001127: (1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order,
p.001127: including in a Federal, State, or local civil or administrative disciplinary proceeding against a
p.001127: provider;
p.001127: (2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative
p.001127: proceeding, including
p.001127: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001127:
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p.001127:
p.001127: Sec. 922 PUBLIC HEALTH SERVICE ACT 1128
p.001127:
p.001127: in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
p.001127: (3) subject to disclosure pursuant to section 552 of title 5, United States Code (commonly known as the
p.001127: Freedom of Infor- mation Act) or any other similar Federal, State, or local law;
p.001127: (4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal
p.001127: proceeding, adminis- trative rulemaking proceeding, or administrative adjudicatory proceeding, including any
p.001127: such proceeding against a provider; or
p.001127:
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p.001127: January 30, 2020
p.001127: (5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or
p.001127: specifically au- thorized under State law.
p.001127: (b) CONFIDENTIALITY OF PATIENT SAFETY WORK PRODUCT.— Notwithstanding any other provision of Federal, State,
p.001127: or local law, and subject to subsection (c), patient safety work product shall be confidential and shall not
p.001127: be disclosed.
p.001127: (c) EXCEPTIONS.—Except as provided in subsection (g)(3)—
p.001127: (1) EXCEPTIONS FROM PRIVILEGE AND CONFIDENTIALITY.— Subsections (a) and (b) shall not apply to (and shall not
p.001127: be con- strued to prohibit) one or more of the following disclosures:
p.001127: (A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after
p.001127: a court makes an in camera determination that such patient safe- ty work product contains evidence of a
p.001127: criminal act and that such patient safety work product is material to the proceeding and not reasonably
p.001127: available from any other source.
p.001127: (B) Disclosure of patient safety work product to the ex- tent required to carry out subsection (f)(4)(A).
p.001127: (C) Disclosure of identifiable patient safety work prod- uct if authorized by each provider identified in such
p.001127: work product.
p.001127: (2) EXCEPTIONS FROM CONFIDENTIALITY.—Subsection (b) shall not apply to (and shall not be construed
p.001127: to prohibit) one or more of the following disclosures:
p.001127: (A) Disclosure of patient safety work product to carry out patient safety activities.
p.001127: (B) Disclosure of nonidentifiable patient safety work product.
p.001127: (C) Disclosure of patient safety work product to grant- ees, contractors, or other entities carrying out
p.001127: research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by
p.001127: rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of
p.001127: protected health information would be allowed for such purpose under the HIPAA con- fidentiality
p.001127: regulations.
p.001127: (D) Disclosure by a provider to the Food and Drug Ad- ministration with respect to a product or activity regulated by
p.001127: the Food and Drug Administration.
p.001127: (E) Voluntary disclosure of patient safety work prod- uct by a provider to an accrediting body that accredits
p.001127: that provider.
p.001127: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001127:
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p.001129: 1129
p.001129: PUBLIC HEALTH SERVICE ACT
p.001129: Sec. 922
p.001129:
p.001129: (F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations
p.001129: and are consistent with the goals of this part.
p.001129: (G) Disclosure of patient safety work product to law enforcement authorities relating to the commission
p.001129: of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes,
p.001129: reasonably under the circumstances, that the patient safety work product that is disclosed is necessary
p.001129: for criminal law en- forcement purposes.
p.001129: (H) With respect to a person other than a patient safe- ty organization, the disclosure of patient safety work prod-
p.001129: uct that does not include materials that—
p.001129: (i) assess the quality of care of an identifiable pro- vider; or
p.001129: (ii) describe or pertain to one or more actions or failures to act by an identifiable provider.
p.001129: (3) EXCEPTION FROM PRIVILEGE.—Subsection (a) shall not apply to (and shall not be construed to prohibit)
p.001129: voluntary dis- closure of nonidentifiable patient safety work product.
p.001129: (d) CONTINUED PROTECTION OF INFORMATION AFTER DISCLO-
p.001129: SURE.—
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p.001129: January 30, 2020
p.001129: (1) IN GENERAL.—Patient safety work product that is dis-
p.001129: closed under subsection (c) shall continue to be privileged and confidential as provided for in subsections
p.001129: (a) and (b), and such disclosure shall not be treated as a waiver of privilege or con- fidentiality, and the
p.001129: privileged and confidential nature of such work product shall also apply to such work product in the pos- session or
p.001129: control of a person to whom such work product was disclosed.
p.001129: (2) EXCEPTION.—Notwithstanding paragraph (1), and sub- ject to paragraph (3)—
p.001129: (A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections
p.001129: pro- vided for in subsection (b) shall no longer apply to the work product so disclosed; and
p.001129: (B) if patient safety work product is disclosed as pro- vided for in subsection (c)(2)(B) (relating to
p.001129: disclosure of nonidentifiable patient safety work product), the privilege and confidentiality protections
p.001129: provided for in subsections
p.001129: (a) and (b) shall no longer apply to such work product.
p.001129: (3) CONSTRUCTION.—Paragraph (2) shall not be construed as terminating or limiting the privilege or
p.001129: confidentiality pro- tections provided for in subsection (a) or (b) with respect to pa- tient safety work product
p.001129: other than the specific patient safety work product disclosed as provided for in subsection (c).
p.001129: (4) LIMITATIONS ON ACTIONS.—
p.001129: (A) PATIENT SAFETY ORGANIZATIONS.—
p.001129: (i) IN GENERAL.—A patient safety organization shall not be compelled to disclose information collected or
p.001129: developed under this part whether or not such in- formation is patient safety work product unless such
p.001129: information is identified, is not patient safety work
p.001129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001129:
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p.001129: Sec. 922 PUBLIC HEALTH SERVICE ACT 1130
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p.001189: SEC. 1219. ø300d–19¿ FAILURE TO COMPLY WITH AGREEMENTS.
p.001189: (a) REPAYMENT OF PAYMENTS.—
p.001189: (1) REQUIREMENT.—The Secretary may, in accordance with subsection (b), require a State to repay any payments received
p.001189: by the State pursuant to section 1211(a) that the Secretary de- termines were not expended by the State in
p.001189: accordance with the agreements required to be made by the State as a condi- tion of the receipt of payments
p.001189: under such section.
p.001189: (2) OFFSET OF AMOUNTS.—If a State fails to make a repay- ment required in paragraph (1), the Secretary may
p.001189: offset the amount of the repayment against any amount due to be paid to the State under section 1211(a).
p.001189: (b) OPPORTUNITY FOR A HEARING.—Before requiring repayment of payments under subsection (a)(1), the Secretary
p.001189: shall provide to the State an opportunity for a hearing.
p.001189: SEC. 1220. ø300d–20¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.001189: (a) IN GENERAL.—
p.001189: (1) FALSE STATEMENTS OR REPRESENTATIONS.—A person may not knowingly and willfully make or cause to be made any
p.001189: false statement or representation of a material fact in connec- tion with the furnishing of items or
p.001189: services for which pay- ments may be made by a State from amounts paid to the State under section 1211(a).
p.001189: (2) CONCEALING OR FAILING TO DISCLOSE INFORMATION.—A person with knowledge of the occurrence of any event
p.001189: affecting the right of the person to receive any payments from amounts paid to the State under section 1211(a) may not
p.001189: conceal or fail to disclose any such event with the intent of fraudulently se- curing such amount.
p.001189: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.001189: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001189: for not more than 5 years, or both.
p.001189: SEC. 1221. ø300d–21¿ TECHNICAL ASSISTANCE AND PROVISION BY SEC- RETARY OF SUPPLIES AND SERVICES IN LIEU OF
p.001189: GRANT FUNDS.
p.001189: (a) TECHNICAL ASSISTANCE.—The Secretary shall, without charge to a State receiving payments under
p.001189: section 1211(a), pro- vide to the State (or to any public or nonprofit private entity des- ignated by the
p.001189: State) technical assistance with respect to the plan- ning, development, and operation of any program carried
p.001189: out pur- suant to section 1211(b). The Secretary may provide such technical assistance directly, through contract, or
p.001189: through grants.
p.001189: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001189: LIEU OF GRANT FUNDS.—
p.001189: (1) IN GENERAL.—Upon the request of a State receiving payments under section 1211(a), the Secretary may,
p.001189: subject to paragraph (2), provide supplies, equipment, and services for
p.001189: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001189:
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p.001191: PUBLIC HEALTH SERVICE ACT
p.001191: Sec. 1231
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p.001293: compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer
p.001293: fails or refuses to secure compliance, the Secretary may—
p.001293: (1) refer the matter to the Attorney General with a rec- ommendation that an appropriate civil action be
p.001293: instituted,
p.001293: (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964, the Age
p.001293: Discrimination Act of 1975, or section 504 of the Rehabilitation Act of 1973, as may be applicable, or
p.001293: (3) take such other action as may be provided by law.
p.001293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001293:
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p.001295: 1295
p.001295: PUBLIC HEALTH SERVICE ACT
p.001295: Sec. 1910
p.001295:
p.001295: (c) When a matter is referred to the Attorney General pursuant to subsection (b)(1), or whenever he has reason
p.001295: to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of
p.001295: law referred to in subsection (a)(1) or in violation of subsection (a)(2), the Attorney General may bring a
p.001295: civil action in any appropriate district court of the United States for such relief as may be appropriate, including
p.001295: injunctive relief.
p.001295: CRIMINAL PENALTY FOR FALSE STATEMENTS
p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
p.001295: fact in con- nection with the furnishing of items or services for which pay- ment may be made by a State from funds
p.001295: allotted to the State under this part, or
p.001295: (2) having knowledge of the occurrence of any event affect- ing his initial or continued right to any such payment
p.001295: conceals or fails to disclose such event with an intent fraudulently to se- cure such payment either in a greater
p.001295: amount than is due or when no such payment is authorized,
p.001295: shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
p.001295:
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p.001295: January 30, 2020
p.001295: EMERGENCY MEDICAL SERVICES FOR CHILDREN
p.001295: SEC. 1910. ø300w–9¿ (a) For activities in addition to the activi- ties which may be carried out by States under section
p.001295: 1904(a)(1)(F), the Secretary may make grants to States or accredited schools of medicine in States to support
p.001295: a program of demonstration projects for the expansion and improvement of emergency medical services for
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p.001301: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will
p.001301: establish and maintain a State mental health planning council in accordance with the condi- tions described in this
p.001301: section.
p.001301: (b) DUTIES.—A condition under subsection (a) for a Council is that the duties of the Council are—
p.001301: (1) to review plans provided to the Council pursuant to section 1915(a) by the State involved and to
p.001301: submit to the State any recommendations of the Council for modifications to the plans;
p.001301: (2) to serve as an advocate for adults with a serious men- tal illness, children with a severe emotional
p.001301: disturbance, and other individuals with mental illnesses or emotional problems; and
p.001301:
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p.001301: January 30, 2020
p.001301: (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of
p.001301: mental health serv- ices within the State.
p.001301: (c) MEMBERSHIP.—
p.001301: (1) IN GENERAL.—A condition under subsection (a) for a Council is that the Council be composed of
p.001301: residents of the State, including representatives of—
p.001301: (A) the principal State agencies with respect to—
p.001301: (i) mental health, education, vocational rehabilita- tion, criminal justice, housing, and social services; and
p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
p.001301: (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional
p.001301: dis- turbance to other members of the Council is sufficient to
p.001301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001301:
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p.001301: Sec. 1915 PUBLIC HEALTH SERVICE ACT 1302
p.001301:
p.001301: provide adequate representation of such children in the de- liberations of the Council; and
p.001301: (B) not less than 50 percent of the members of the Council are individuals who are not State employees
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p.001317: seeking treatment services, a funding agreement for a grant under section 1921 is that the State involved
p.001317: will improve the process in the State for re- ferring the individuals to treatment facilities that can provide
p.001317: to the individuals the treatment modality that is most appropriate for the individuals.
p.001317: (b) PROFESSIONAL DEVELOPMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001317: will ensure that prevention, treatment, and recovery personnel operating in the State’s substance use disorder
p.001317: prevention, treatment, and recovery systems have an opportunity to receive training, on an ongoing basis,
p.001317: concerning—
p.001317: (1) recent trends in substance use disorders in the State;
p.001317: (2) improved methods and evidence-based practices for pro- viding substance use disorder prevention and treatment
p.001317: serv- ices;
p.001317: (3) performance-based accountability;
p.001317: (4) data collection and reporting requirements; and
p.001317: (5) any other matters that would serve to further improve the delivery of substance use disorder prevention and
p.001317: treat- ment services within the State.
p.001317: (c) COORDINATION OF VARIOUS ACTIVITIES AND SERVICES.—A funding agreement for a grant under section 1921 is
p.001317: that the State involved will coordinate prevention and treatment activities with the provision of other
p.001317: appropriate services (including health, social, correctional and criminal justice, educational, vocational rehabilita-
p.001317: tion, and employment services).
p.001317:
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p.001317: January 30, 2020
p.001317: 6 So in law. See section 202 of Public Law 102–321 (106 Stat. 396). Probably should be ‘‘woman’’.
p.001317: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: Sec. 1930 PUBLIC HEALTH SERVICE ACT 1318
p.001317:
p.001317: (d) 8 WAIVER OF REQUIREMENT.—
p.001317: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may provide to a State a waiver of any or all of
p.001317: the re- quirements established in this section if the Secretary deter- mines that, with respect to
p.001317: services for the prevention and treatment of substance use disorders, the requirement involved is unnecessary for
p.001317: maintaining quality in the provision of such services in the State.
p.001317: (2) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001317: under para- graph (1) not later than 120 days after the date on which the request is made.
p.001317: (3) APPLICABILITY OF WAIVER.—Any waiver provided by the Secretary under paragraph (1) shall be applicable only
p.001317: to the fiscal year involved.
p.001317: øSection 1929 was repealed by section 8002(f) of Public Law 114–255.¿
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p.001331: records available to the Sec- retary or the Comptroller General, or any of their duly author- ized
p.001331: representatives, for examination, copying, or mechanical reproduction on or off the premises of the
p.001331: appropriate entity upon a reasonable request therefor.
p.001331: (3) LIMITATIONS ON AUTHORITY.—The Secretary may not institute proceedings under subsection (c) unless the
p.001331: Secretary has conducted an investigation concerning whether the State has expended payments under the program
p.001331: involved in accord- ance with the agreements required under the program. Any such investigation shall be
p.001331: conducted within the State by qualified investigators.
p.001331: SEC. 1946. ø300x–56¿ PROHIBITIONS REGARDING RECEIPT OF FUNDS.
p.001331: (a) ESTABLISHMENT.—
p.001331: (1) CERTAIN FALSE STATEMENTS AND REPRESENTATIONS.—A person shall not knowingly and willfully make or cause
p.001331: to be made any false statement or representation of a material fact in connection with the furnishing of
p.001331: items or services for which payments may be made by a State from a grant made to the State under section
p.001331: 1911 or 1921.
p.001331: (2) CONCEALING OR FAILING TO DISCLOSE CERTAIN EVENTS.—A person with knowledge of the
p.001331: occurrence of any event affecting the initial or continued right of the person to receive any payments from
p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
p.001331: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.001331: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.001331: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.001331: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
p.001331:
p.001331:
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p.001381: pay.
p.001381: (d) PUNITIVE DAMAGES.—
p.001381: (1) If sought by the plaintiff, the third stage of such an ac- tion shall be held to determine the amount of
p.001381: punitive dam-
p.001381:
p.001381:
p.001381:
p.001381: January 30, 2020
p.001381: 24 Effective October 1, 1988.
p.001381:
p.001381: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001381:
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p.001381:
p.001381: Sec. 2125 PUBLIC HEALTH SERVICE ACT 1382
p.001381:
p.001381: ages a vaccine manufacturer found to be liable under section 2122 shall be required to pay.
p.001381: (2) If in such an action the manufacturer shows that it complied, in all material respects, with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act applicable to
p.001381: the vaccine and related to the vaccine injury or death with respect to which the action was brought, the
p.001381: manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
p.001381: (A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a pro-
p.001381: ceeding for approval of the vaccine under section 351,
p.001381: (B) intentional and wrongful withholding of informa- tion relating to the safety or efficacy of the
p.001381: vaccine after its approval, or
p.001381: (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
p.001381: which activity related to the vaccine-related injury or death for which the civil action was brought.
p.001381: (e) EVIDENCE.—In any stage of a civil action, the Vaccine In- jury Table, any finding of fact or
p.001381: conclusion of law of the United States Claims Court or a special master in a proceeding on a peti- tion filed
p.001381: under section 2111 and the final judgment of the United States Claims Court and subsequent appellate review on such a
p.001381: pe- tition shall not be admissible.
p.001381: PART C—ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES
p.001381:
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p.001381:
p.001381: January 30, 2020
p.001381:
p.001381: RECORDING AND REPORTING OF INFORMATION
p.001381: SEC. 2125. ø300aa–25¿ (a) GENERAL RULE.—Each health care provider who administers a vaccine set forth in the
p.001381: Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person’s permanent
p.001381: medical record (or in a permanent of- fice log or file to which a legal representative shall have
p.001381: access upon request) with respect to each such vaccine—
p.001381: (1) the date of administration of the vaccine,
p.001381: (2) the vaccine manufacturer and lot number of the vac- cine,
p.001381: (3) the name and address and, if appropriate, the title of the health care provider administering the
p.001381: vaccine, and
...

p.001425:
p.001425:
p.001425:
p.001425:
p.001425:
p.001425:
p.001425: January 30, 2020
p.001425: compliance with the agreements required to be contained in the applications submitted to the Secretary pursuant
p.001425: to section 2407.
p.001425: (2) Each State, and each entity receiving funds from pay- ments made to a State under section 2401(a),
p.001425: shall make ap- propriate books, documents, papers, and records available to the Secretary and the
p.001425: Comptroller General of the United States, or any of their duly authorized representatives, for ex- amination,
p.001425: copying, or mechanical reproduction on or off the premises of the appropriate entity upon a reasonable
p.001425: request therefor.
p.001425: (3)(A) In conducting any investigation in a State, the Sec- retary and the Comptroller General of the
p.001425: United States may not make a request for any information not readily available to the State, or to an
p.001425: entity receiving funds from payments made to the State under section 2401(a), or make an unreason- able request for
p.001425: information to be compiled, collected, or trans- mitted in any form not readily available.
p.001425: (B) Subparagraph (A) shall not apply to the collection, compilation, or transmittal of data in the
p.001425: course of a judicial proceeding.
p.001425: SEC. 2410. ø300dd–9¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.001425: (a) IN GENERAL.—A person may not knowingly make or cause to be made any false statement or representation of a
p.001425: material fact in connection with the furnishing of items or services for which amounts may be paid by a
p.001425: State from payments received by the State under section 2401(a).
p.001425: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.001425: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001425: for not more than 5 years, or both.
p.001425: SEC. 2411. ø300dd–10¿ TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001425: LIEU OF GRANT FUNDS.
p.001425: (a) TECHNICAL ASSISTANCE.—Upon the request of a State re- ceiving payments under section 2401(a), the
p.001425: Secretary may, with- out charge to the State, provide to the State (or to any public or private entity
p.001425: designated by the State) technical assistance with re- spect to the planning, development, and operation of any
p.001425: program or service carried out pursuant to this part. The Secretary may pro- vide such technical assistance
p.001425: directly, through contract, or through grants.
p.001425: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001425: LIEU OF GRANT FUNDS.—
p.001425: (1) Upon the request of a State receiving payments under section 2401(a), the Secretary may, subject to
p.001425: paragraph (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying
p.001425: out this part and, for such pur- pose, may detail to the State any officer or employee of the De- partment of
p.001425: Health and Human Services.
p.001425: (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments
p.001425: under sec- tion 2401(a) to the State by an amount equal to the costs of
p.001425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001425:
p.001425:
p.001425:
p.001425:
p.001425:
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p.001439: January 30, 2020
p.001439: premises of the appropriate entity upon a reasonable request therefor.
p.001439: (4)(A) In conducting any investigation in a State, the Sec- retary and the Comptroller General of the
p.001439: United States may not make a request for any information not readily available to the State, or to an
p.001439: entity receiving funds from payments made to the State under section 2501(a), or make an unreason- able request for
p.001439: information to be compiled, collected, or trans- mitted in any form not readily available.
p.001439: (B) Subparagraph (A) shall not apply to the collection, compilation, or transmittal of data in the
p.001439: course of a judicial proceeding.
p.001439: SEC. 2509. ø300ee–19¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.001439: (a) IN GENERAL.—
p.001439: (1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in
p.001439: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.001439: payments received by the State under section 2501(a).
p.001439: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.001439: amounts from payments made to the State under section 2501(a) may not conceal or fail to disclose any
p.001439: such event with the intent of fraudulently securing such amounts.
p.001439: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.001439: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001439: for not more than 5 years, or both.
p.001439: SEC. 2510. ø300ee–20¿ TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY OF SUPPLIES AND SERVICES
p.001439: IN LIEU OF GRANT FUNDS.
p.001439: (a) TECHNICAL ASSISTANCE.—The Secretary may provide train- ing and technical assistance to States with respect to
p.001439: the planning, development, and operation of any program or service carried out pursuant to this part. The
p.001439: Secretary may provide such technical as- sistance directly or through grants or contracts.
p.001439: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001439: LIEU OF GRANT FUNDS.—
p.001439: (1) Upon the request of a State receiving payments under this part, the Secretary may, subject to paragraph
p.001439: (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying out such part and, for
p.001439: such purpose, may de- tail to the State any officer or employee of the Department of Health and Human
p.001439: Services.
p.001439: (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments
p.001439: under sec- tion 2501(a) to the State by an amount equal to the costs of detailing personnel and the
p.001439: fair market value of any supplies, equipment, or services provided by the Secretary. The Sec- retary
p.001439: shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.001439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001439:
p.001439:
...

p.001505: the program. This subparagraph may not be con- strued as affecting the requirement of subparagraph (A)
p.001505: with respect to a health entity that treats an individual for HIV/ AIDS.
p.001505: (3) The program under paragraph (1) is carried out in ac- cordance with the following:
p.001505: (A) Partners are provided with an appropriate oppor- tunity to learn that the partners have been exposed
p.001505: to HIV/AIDS, subject to subparagraph (B).
p.001505: (B) The State does not inform partners of the identity of the infected individuals involved.
p.001505: (C) Counseling and testing for HIV/AIDS are made available to the partners and to infected individuals,
p.001505: and such counseling includes information on modes of trans- mission for the disease, including information
p.001505: on prenatal and perinatal transmission and preventing transmission.
p.001505: (D) Counseling of infected individuals and their part- ners includes the provision of information regarding
p.001505: thera- peutic measures for preventing and treating the deteriora- tion of the immune system and conditions arising from
p.001505: the disease, and the provision of other prevention-related in- formation.
p.001505: (E) Referrals for appropriate services are provided to partners and infected individuals, including
p.001505: referrals for support services and legal aid.
p.001505: (F) Notifications under subparagraph (A) are provided in person, unless doing so is an unreasonable burden on
p.001505: the State.
p.001505: (G) There is no criminal or civil penalty on, or civil li- ability for, an infected individual if the individual
p.001505: chooses not to identify the partners of the individual, or the indi- vidual does not otherwise cooperate
p.001505: with such program.
p.001505: (H) The failure of the State to notify partners is not a basis for the civil liability of any health entity
p.001505: who under the program reported to the State the identity of the in- fected individual involved.
p.001505: (I) The State provides that the provisions of the pro- gram may not be construed as prohibiting the
p.001505: State from providing a notification under subparagraph (A) without the consent of the infected individual
p.001505: involved.
p.001505: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001505:
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p.001505:
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p.001505:
p.001505: Sec. 2651 PUBLIC HEALTH SERVICE ACT 1506
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Political / migrant

Searching for indicator migrant:

(return to top)
p.000001: extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency
p.000001: involving the national defense pro-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 217 PUBLIC HEALTH SERVICE ACT 22
p.000001:
p.000001: claimed by the President, he may by Executive order declare the commissioned corps of the Service to be
p.000001: a military service. Upon such declaration, and during the period of such war or such emer- gency or such part
p.000001: thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the
p.000001: land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President,
p.000001: be subject to the Uniform Code of Military Justice, and (c) shall continue to operate as part of the
p.000001: Service except to the extent that the President may direct as Com- mander in Chief.
p.000001:
p.000001: NATIONAL ADVISORY COUNCILS
p.000001: SEC. 217. ø218¿ (a) Within 120 days of the date of the enact- ment of this subsection, the Secretary
p.000001: shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred
p.000001: to as the Council) which shall advise, consult with, and make recommendations to, the Secretary on matters con-
p.000001: cerning the organization, operation, selection, and funding of mi- grant health centers and other entities
p.000001: under grants and contracts under section 329. 8
p.000001: (b) The Council shall consist of fifteen members, at least twelve of whom shall be members of the governing
p.000001: boards of migrant health centers or other entities assisted under section 329. 8 Of such twelve members
p.000001: who are members of such governing boards, at least nine shall be chosen from among those members of
p.000001: such governing boards who are being served by such centers or grantees and who are familiar with the delivery of health
p.000001: care to migratory agricultural workers and seasonal agricultural workers. The re- maining three Council
p.000001: members shall be individuals qualified by training and experience in the medical sciences or in the adminis-
p.000001: tration of health programs.
p.000001: (c) Each member of the Council shall hold office for a term of four years, except that (1) any member
p.000001: appointed to fill a vacancy occurring prior to the expiration of the term for which his prede- cessor was
p.000001: appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after
p.000001: the date of enactment of this subsection shall expire as follows: four shall expire four years after such
p.000001: date, four shall expire three years after such date, four shall expire two years after such date, and three
p.000001: shall expire one year after such date, as designated by the Secretary at the time of appointment.
p.000001: (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
p.000001: TRAINING OF OFFICERS
p.000001: SEC. 218. ø218a¿ (a) Appropriations available for the pay and allowances of commissioned officers of the
p.000001: Service shall also be available for the pay and allowances of any such officer on active
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
...

p.000285: (A) The term ‘‘adoption organization’’ means a na- tional, regional, or local organization—
p.000285: (i) among whose primary purposes are adoption;
p.000285: (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa-
p.000285: tion and referrals to pregnant women; and
p.000285: (iii) that is a nonprofit private entity.
p.000285: (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who
p.000285: provide pregnancy or adoption information and referrals (or will provide such information and referrals
p.000285: after receiving training under a grant under paragraph (1)).
p.000285: (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health
p.000285: services to pregnant women.
p.000285: (5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A condition for the receipt of a grant under paragraph (1) is
p.000285: that the adoption organization involved agree to make reasonable efforts to ensure that the eligible
p.000285: health centers with respect to which training under the grant is provided include—
p.000285: (A) eligible health centers that receive grants under section 1001 (relating to voluntary family
p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000285: adoption informa- tion and referral, upon request, are provided by eligible
p.000285:
p.000285:
p.000285:
p.000285: January 30, 2020
p.000285: 36 Public Law 106–310, enacted October 17, 2000.
...

p.000291: a non- profit entity.
p.000291: (B) TELEHEALTH NETWORKS.—
p.000291: (i) IN GENERAL.—To be eligible to receive a grant under subsection (d)(1), an entity shall demonstrate
p.000291: that the entity will provide services through a tele- health network.
p.000291: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000291:
p.000291:
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p.000291:
p.000291: Sec. 330I PUBLIC HEALTH SERVICE ACT 292
p.000291:
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p.000291: January 30, 2020
p.000291:
p.000291: (ii) NATURE OF ENTITIES.—Each entity partici- pating in the telehealth network may be a nonprofit or
p.000291: for-profit entity.
p.000291: (iii) COMPOSITION OF NETWORK.—The telehealth network shall include at least 2 of the following enti- ties
p.000291: (at least 1 of which shall be a community-based health care provider):
p.000291: (I) Community or migrant health centers or other Federally qualified health centers.
p.000291: (II) Health care providers, including phar- macists, in private practice.
p.000291: (III) Entities operating clinics, including rural health clinics.
p.000291: (IV) Local health departments.
p.000291: (V) Nonprofit hospitals, including community access hospitals.
p.000291: (VI) Other publicly funded health or social service agencies.
p.000291: (VII) Long-term care providers.
p.000291: (VIII) Providers of health care services in the home.
p.000291: (IX) Providers of outpatient mental health services and entities operating outpatient mental health
p.000291: facilities.
p.000291: (X) Local or regional emergency health care providers.
p.000291: (XI) Institutions of higher education.
p.000291: (XII) Entities operating dental clinics.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—To be eligi- ble to receive a grant under subsection (d)(2), an
p.000291: entity shall be a nonprofit entity.
p.000291: (g) APPLICATIONS.—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation
p.000291: with the appropriate State office of rural health or another appropriate State entity, shall prepare and
p.000291: submit to the Secretary an application, at such time, in such manner, and containing such information as the
p.000291: Sec- retary may require, including—
p.000291: (1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000291: (2) a description of the manner in which the project funded under the grant will meet the health care needs of
...

p.000305: which is a rational area for the deliv- ery of health services) which the Secretary determines has a health manpower
p.000305: shortage, (B) a population group which the Secretary de- termines has such a shortage, or (C) a public or
p.000305: nonprofit private medical facility or other public facility which the Secretary deter- mines has such a
p.000305: shortage. All Federally qualified health centers and rural health clinics, as defined in section 1861(aa) of the
p.000305: Social Security Act (42 U.S.C. 1395x(aa)), that meet the requirements of section 334 shall be
p.000305: automatically designated as having such a shortage. The Secretary shall not remove an area from the
p.000305: areas determined to be health professional shortage areas under subpara- graph (A) of the preceding sentence
p.000305: until the Secretary has af- forded interested persons and groups in such area an opportunity to provide
p.000305: data and information in support of the designation as a health professional shortage area or a population group
p.000305: described in subparagraph (B) of such sentence or a facility described in sub- paragraph (C) of such sentence, and has
p.000305: made a determination on the basis of the data and information submitted by such persons and groups and
p.000305: other data and information available to the Sec- retary.
p.000305: (2) For purposes of this subsection, the term ‘‘medical facility’’ means a facility for the delivery of
p.000305: health services and includes—
p.000305: (A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility,
p.000305: facility for long-term care, community mental health center, migrant health center, facility operated
p.000305: by a city or county health de- partment, and community health center and which is not rea- sonably
p.000305: accessible to an adequately served area;
p.000305: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000305:
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p.000305:
p.000307: 307
p.000307: PUBLIC HEALTH SERVICE ACT
p.000307: Sec. 332
p.000307:
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p.000307: January 30, 2020
p.000307: (B) such a facility of a State correctional institution or of the Indian Health Service, and a health program
p.000307: or facility op- erated by a tribe or tribal organization under the Indian Self- Determination Act;
p.000307: (C) such a facility used in connection with the delivery of health services under section 321 (relating
p.000307: to hospitals), 322 (relating to care and treatment of persons under quarantine and others), 323 (relating
...

p.000369: supply of vaccines provided by the State to any of the entities described in subsection (a)(2).
p.000369: BREAST AND CERVICAL CANCER INFORMATION
p.000369: SEC. 340D. ø256d¿ (a) IN GENERAL.—As a condition of receiv- ing grants, cooperative agreements, or
p.000369: contracts under this Act, each of the entities specified in subsection (c) shall, to the extent
p.000369: determined to be appropriate by the Secretary, make available in- formation concerning breast and cervical
p.000369: cancer.
p.000369: (b) CERTAIN AUTHORITIES.—In carrying out subsection (a), an entity specified in subsection (c)—
p.000369: (1) may make the information involved available to such individuals as the entity determines appropriate;
p.000369: (2) may, as appropriate, provide information under sub- section (a) on the need for self-examination of the
p.000369: breasts and on the skills for such self-examinations;
p.000369: (3) shall provide information under subsection (a) in the language and cultural context most appropriate to the
p.000369: individ- uals to whom the information is provided; and
p.000369: (4) shall refer such clients as the entities determine appro- priate for breast and cervical cancer screening,
p.000369: treatment, or other appropriate services.
p.000369: (c) RELEVANT ENTITIES.—The entities specified in this sub- section are the following:
p.000369: (1) Entities receiving assistance under section 317F (relat- ing to tuberculosis) 53.
p.000369: (2) Entities receiving assistance under section 318 (relat- ing to sexually transmitted diseases).
p.000369: (3) Migrant health centers receiving assistance under sec- tion 329 54.
p.000369: (4) Community health centers receiving assistance under section 330 54.
p.000369: (5) Entities receiving assistance under section 330(h) (re- lating to homeless individuals).
p.000369: (6) Entities receiving assistance under section 340A 54 (re- lating to health services for residents of public
p.000369: housing).
p.000369: (7) Entities providing services with assistance under title V or title XIX.
p.000369: (8) Entities receiving assistance under section 1001 (relat- ing to family planning).
p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
p.000369:
p.000369:
p.000369:
p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000369:
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.001043: (3) ADMINISTRATION.—
p.001043: (A) IN GENERAL.—An applicant shall not use more than 10 percent of the funds made available to such appli- cant
p.001043: under subsection (a) for administrative expenses.
p.001043: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001043:
p.001043:
p.001043:
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p.001043:
p.001045: 1045
p.001045: PUBLIC HEALTH SERVICE ACT
p.001045: Sec. 755
p.001045:
p.001045: (B) TRAINING.—Not more than 10 percent of the indi- viduals receiving training with funds made available to an
p.001045: applicant under subsection (a) shall be trained as doctors of medicine or doctors of osteopathy.
p.001045: (C) LIMITATION.—An institution that receives a grant under this section shall use amounts received under
p.001045: such grant to supplement, not supplant, amounts made avail- able by such institution for activities of the type
p.001045: described in subsection (b)(1) in the fiscal year preceding the year for which the grant is received.
p.001045: (c) APPLICATIONS.—Applications submitted for assistance under this section shall—
p.001045: (1) be jointly submitted by at least two eligible applicants with the express purpose of assisting
p.001045: individuals in academic institutions in establishing long-term collaborative relation- ships with health care
p.001045: providers in rural areas; and
p.001045: (2) designate a rural health care agency or agencies for clinical treatment or training, including
p.001045: hospitals, community health centers, migrant health centers, rural health clinics, community behavioral and
p.001045: mental health centers, long-term care facilities, Native Hawaiian health centers, or facilities op- erated by the
p.001045: Indian Health Service or an Indian tribe or tribal organization or Indian organization under a contract with
p.001045: the Indian Health Service under the Indian Self-Determination Act.
p.001045: (d) DEFINITIONS.—For the purposes of this section, the term ‘‘rural’’ means geographic areas that are located
p.001045: outside of standard metropolitan statistical areas.
p.001045: SEC. 755. ø294e¿ ALLIED HEALTH AND OTHER DISCIPLINES.
p.001045: (a) IN GENERAL.—The Secretary may make grants or contracts under this section to help entities fund activities
p.001045: of the type de- scribed in subsection (b).
p.001045: (b) ACTIVITIES.—Activities of the type described in this sub- section include the following:
p.001045: (1) Assisting entities in meeting the costs associated with expanding or establishing programs that
p.001045: will increase the number of individuals trained in allied health professions. Pro- grams and activities funded
p.001045: under this paragraph may in- clude—
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045:
p.001045: January 30, 2020
p.001045: (A) those that expand enrollments in allied health pro- fessions with the greatest shortages or whose services
p.001045: are most needed by the elderly;
p.001045: (B) those that provide rapid transition training pro- grams in allied health fields to individuals who
...

p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001069:
p.001069:
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p.001069:
p.001071: 1071
p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
p.001071: center-affili- ated treatment program), correctional facility or program, youth detention center or program,
p.001071: inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or
p.001071: other specialty community be- havioral health center, recovery center, school, community- based organization,
p.001071: telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal
p.001071: organization, Federal medical facility, or any other facility as determined appropriate for purposes of this
p.001071: section by the Secretary.
p.001071: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $25,000,000
p.001071: for each of fiscal years 2019 through 2023.
p.001071: PART G—GENERAL PROVISIONS
p.001071:
p.001071:
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p.001071:
p.001071: January 30, 2020
p.001071: SEC. 791. ø295j¿ PREFERENCES AND REQUIRED INFORMATION IN CER- TAIN PROGRAMS.
p.001071: (a) PREFERENCES IN MAKING AWARDS.—
p.001071: (1) IN GENERAL.—Subject to paragraph (2), in making awards of grants or contracts under any of
p.001071: sections 747 and 750, the Secretary shall give preference to any qualified appli- cant that—
p.001071: (A) has a high rate for placing graduates in practice settings having the principal focus of serving
p.001071: residents of medically underserved communities;
p.001071: (B) during the 2-year period preceding the fiscal year for which such an award is sought, has achieved a
p.001071: signifi- cant increase in the rate of placing graduates in such set- tings; or
p.001071: (C) utilizes a longitudinal evaluation (as described in section 761(d)(2)) and reports data from such system to
p.001071: the national workforce database (as established under section 761(b)(2)(E)).
...

p.001079: (v) health systems management services; and
p.001079: (C) who has not received a degree of doctor of medi- cine, a degree of doctor of osteopathy, a degree
p.001079: of doctor of dentistry or an equivalent degree, a degree of doctor of veterinary medicine or an
p.001079: equivalent degree, a degree of
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001079:
p.001079:
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p.001079:
p.001081: 1081
p.001081: PUBLIC HEALTH SERVICE ACT
p.001081: Sec. 799B
p.001081:
p.001081: doctor of optometry or an equivalent degree, a degree of doctor of podiatric medicine or an equivalent degree,
p.001081: a de- gree of bachelor of science in pharmacy or an equivalent degree, a degree of doctor of pharmacy or an
p.001081: equivalent de- gree, a graduate degree in public health or an equivalent degree, a degree of doctor of
p.001081: chiropractic or an equivalent degree, a graduate degree in health administration or an equivalent degree,
p.001081: a doctoral degree in clinical psychology or an equivalent degree, or a degree in social work or an
p.001081: equivalent degree or a degree in counseling or an equiva- lent degree.
p.001081: (6) The term ‘‘medically underserved community’’ means an urban or rural area or population that—
p.001081: (A) is eligible for designation under section 332 as a health professional shortage area;
p.001081: (B) is eligible to be served by a migrant health center under section 329 25, a community health center under sec- tion
p.001081: 330 25, a grantee under section 330(h) (relating to homeless individuals), or a grantee under section
p.001081: 340A 25 (relating to residents of public housing);
p.001081: (C) has a shortage of personal health services, as de- termined under criteria issued by the Secretary under
p.001081: sec- tion 1861(aa)(2) of the Social Security Act (relating to rural health clinics); or
p.001081: (D) is designated by a State Governor (in consultation with the medical community) as a shortage area or medi-
p.001081: cally underserved community.
p.001081: (7) The term ‘‘Department’’ means the Department of Health and Human Services.
p.001081: (8) The term ‘‘nonprofit’’ refers to the status of an entity owned and operated by one or more
p.001081: corporations or associa- tions no part of the net earnings of which inures, or may law- fully inure, to the
p.001081: benefit of any private shareholder or indi- vidual.
p.001081: (9) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.001081: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.001081: American Samoa, and the Trust Territory of the Pacific Islands.
p.001081: (10)(A) Subject to subparagraph (B), the term ‘‘underrep- resented minorities’’ means, with respect to a
p.001081: health profes- sion, racial and ethnic populations that are underrepresented in the health profession
p.001081: relative to the number of individuals who are members of the population involved.
...

p.001433: for a fiscal year unless the State involved agrees that—
p.001433: (1) all programs conducted or supported by the State with such payments will establish objectives for the
p.001433: program and will determine the extent to which the objectives are met;
p.001433: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001433:
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p.001433:
p.001433:
p.001435: 1435
p.001435: PUBLIC HEALTH SERVICE ACT
p.001435: Sec. 2506
p.001435:
p.001435: (2) information provided under this part will be scientif- ically accurate and factually correct;
p.001435: (3) in carrying out section 2501(b), the State will give pri- ority to programs described in section 2502(10) for
p.001435: individuals described in such section;
p.001435: (4) with respect to a State in which there is a substantial number of individuals who are intravenous substance
p.001435: abusers, the State will place priority on activities under this part di- rected at such substance abusers;
p.001435: (5) with respect to a State in which there is a significant incidence of reported cases of acquired immune
p.001435: deficiency syn- drome, the State will—
p.001435: (A) for the purpose described in subsection (b) of sec- tion 2501, expend not less than 50 percent of payments
p.001435: re- ceived under subsection (a) of such section for a fiscal year—
p.001435: (i) to make grants to public entities, to migrant health centers (as defined in section 329(a)), to
p.001435: com- munity health centers (as defined in section 330(a)) 3, and to nonprofit private entities concerned
p.001435: with ac- quired immune deficiency syndrome; or
p.001435: (ii) to enter into contracts with public and private entities; and
p.001435: (B) of the amounts reserved for a fiscal year by the State for expenditures required in subparagraph
p.001435: (A), ex- pend not less than 50 percent to carry out section 2502(10) through grants to nonprofit private
p.001435: entities, including mi- nority entities, concerned with acquired immune deficiency syndrome located in and
p.001435: representative of communities and subpopulations reflecting the local incidence of such syndrome;
p.001435: (6) with respect to programs carried out pursuant to sec- tion 2502(10), the State will ensure that any
p.001435: applicant for a grant under such section agrees—
p.001435: (A) that any educational or informational materials developed with a grant pursuant to such section will
p.001435: con- tain material, and be presented in a manner, that is spe- cifically directed toward the group for
p.001435: which such mate- rials are intended;
p.001435: (B) to provide a description of the manner in which the applicant has planned the program in
p.001435: consultation with, and of the manner in which such applicant will con- sult during the conduct of the program with—
p.001435: (i) appropriate local officials and community groups for the area to be served by the program;
p.001435: (ii) organizations comprised of, and representing, the specific population to which the education or pre-
p.001435: vention effort is to be directed; and
...

p.001441: of toll-free telephone communications to provide information to, and respond to queries from, the public
p.001441: concerning acquired immune deficiency syndrome. Such communications shall be available on a 24-hour basis.
p.001441: SEC. 2522. ø300ee–32¿ PUBLIC INFORMATION CAMPAIGNS.
p.001441: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.001441: grants to public entities, and to nonprofit private entities concerned with acquired immune deficiency
p.001441: syndrome, and shall enter into con- tracts with public and private entities, for the development and de- livery
p.001441: of public service announcements and paid advertising mes- sages that warn individuals about activities
p.001441: which place them at risk of infection with the etiologic agent for such syndrome.
p.001441: (b) REQUIREMENT OF APPLICATION.—The Secretary may not provide financial assistance under subsection (a) unless—
p.001441: (1) an application for such assistance is submitted to the Secretary;
p.001441: (2) with respect to carrying out the purpose for which the assistance is to be provided, the
p.001441: application provides assur- ances of compliance satisfactory to the Secretary; and
p.001441: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001441: assurances, and information as the Secretary determines to be necessary to carry out this section.
p.001441: SEC. 2523. ø300ee–33¿ PROVISION OF INFORMATION TO UNDERSERVED POPULATIONS.
p.001441: (a) IN GENERAL.—The Secretary may make grants to public en- tities, to migrant health centers (as defined in
p.001441: section 329(a) 5), to community health centers (as defined in section 330(a)) 5, and to nonprofit private
p.001441: entities concerned with acquired immune defi- ciency syndrome, for the purpose of assisting grantees in providing
p.001441: services to populations of individuals that are underserved with re- spect to programs providing information on the
p.001441: prevention of expo- sure to, and the transmission of, the etiologic agent for acquired immune deficiency
p.001441: syndrome.
p.001441: (b) PREFERENCES IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give
p.001441: preference to any ap- plicant for such a grant that has the ability to disseminate rapidly the information described in
p.001441: subsection (a) (including any national organization with such ability).
p.001441:
p.001441:
p.001441:
p.001441:
p.001441: January 30, 2020
p.001441: 4 So in law. The word ‘‘the’’ appears twice.
p.001441: 5 See footnote for section 217(a).
p.001441:
p.001441:
p.001441: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001441:
p.001441:
p.001441:
p.001441:
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p.001441:
p.001441: Sec. 2524 PUBLIC HEALTH SERVICE ACT 1442
p.001441:
p.001441: SEC. 2524. ø300ee–34¿ AUTHORIZATION OF APPROPRIATIONS.
p.001441: (a) IN GENERAL.—For the purpose of carrying out sections 2521 through 2523, there are authorized to
p.001441: be appropriated
p.001441: $105,000,000 for fiscal year 1989 and such sums as may be nec- essary for each of the fiscal years 1990 and
p.001441: 1991.
...

Political / person in detention center

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p.000001: with the Secretary of the Treasury, whenever in his judg- ment the purposes of the gifts will be served
p.000001: thereby.
p.000001:
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p.000001: January 30, 2020
p.000001: USE OF IMMIGRATION STATION HOSPITALS
p.000001:
p.000001: SEC. 232. ø238a¿ The Immigration and Naturalization Service may, by agreement of the heads of the departments
p.000001: concerned, per- mit the Public Health Service to use hospitals at immigration sta- tions for the care of Public
p.000001: Health Service patients. The Surgeon General shall reimburse the Immigration and Naturalization Serv- ice for the
p.000001: actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which
p.000001: reimbursement shall be covered into the proper Immigration and Naturalization Service ap- propriation, or such
p.000001: costs may be paid from working funds estab- lished as provided by law, but no charge shall be made for the ex-
p.000001: pense of physical upkeep of the hospitals. The Immigration and Naturalization Service shall reimburse the
p.000001: Surgeon General for the
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 51 PUBLIC HEALTH SERVICE ACT Sec. 236
p.000001:
p.000001: care and treatment of persons detained in hospitals of the Public Health Service at the request of the
p.000001: Immigration and Naturaliza- tion Service unless such persons are entitled to care and treatment under section 322(a).
p.000017: 17
p.000017: MONEY COLLECTED FOR CARE OF PATIENTS
p.000017: SEC. 233. ø238b¿ Money collected as provided by law for ex- penses incurred in the care and treatment
p.000017: of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts
p.000017: received from any executive department on ac- count of care and treatment of pay patients, shall be
p.000017: covered into the appropriation from which the expenses of such care and treat- ment were paid.
p.000017: TRANSPORTATION OF REMAINS OF OFFICERS
p.000017: SEC. 234. ø238c¿ Appropriations available for traveling ex- penses of the Service shall be available for
p.000017: meeting the cost of preparation for burial and of transportation to the place of burial of remains of
p.000017: commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations
p.000017: available for carrying out the provisions of this Act shall also be available for the payment of such
p.000017: expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may
p.000017: be authorized under other provisions of law.
p.000017: GRANTS TO FEDERAL INSTITUTIONS
p.000017: SEC. 235. ø238d¿ Appropriations to the Public Health Service available under this Act for research,
p.000017: training, or demonstration project grants or for grants to expand existing treatment and re- search
...

p.000253: President, select suitable sites for and establish such addi- tional institutions, hospitals, and stations in the
p.000253: States and possessions of the United States as in his judgment are nec- essary to enable the Service to
p.000253: discharge its functions and du- ties;
p.000253: (b) Provide for the transfer of Public Health Service pa- tients, in the care of attendants where necessary,
p.000253: between hos- pitals and stations operated by the Service or between such hospitals and stations and other
p.000253: hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such
p.000253: transfer;
p.000253: (c) Provide for the disposal of articles produced by patients in the course of their curative treatment, either by
p.000253: allowing the patient to retain such articles or by selling them and depos- iting the money received therefor
p.000253: to the credit of the appropria- tion from which the materials for making the articles were purchased;
p.000253: (d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of
p.000253: deceased patients; and
p.000253: (e) Provide, to the extent the Surgeon General determines that other public or private funds are not available
p.000253: therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable
p.000253: burial expenses for, any patient dying in a hospital or station.
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253: January 30, 2020
p.000253:
p.000253: CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN OTHER PERSONS
p.000253: SEC. 322. ø249¿ (a) Any person when detained in accordance with quarantine laws, or, at the request of
p.000253: the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for
p.000253: by the Public Health Service.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
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p.000253:
p.000253:
p.000255: 255
p.000255: PUBLIC HEALTH SERVICE ACT
p.000255: Sec. 324
p.000255:
p.000255: (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in
p.000255: accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in
p.000255: case of emergency.
p.000255: (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with
p.000255: regulations, receive such care and treatment at the expense of the Service from public or private medical or
p.000255: hospital facilities other than those of the Service, when authorized by the officer in charge of the station
p.000255: at which the ap- plication is made.
p.000255: CARE AND TREATMENT OF FEDERAL PRISONERS 27
p.000255: SEC. 323. ø250¿ The Service shall supervise and furnish med- ical treatment and other necessary medical,
p.000255: psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended
p.000255: (U.S.C., 1940 edition, title 18, secs. 751, 752), 28 in penal and correctional institutions of the United
p.000255: States.
...

p.000439: the recommendation of the Secretary, in consultation with the Sur- geon General, 72.
p.000439: (c) Except as provided in subsection (d), regulations prescribed under this section, insofar as they provide for the
p.000439: apprehension, de- tention, examination, or conditional release of individuals, shall be
p.000439:
p.000439:
p.000439:
p.000439:
p.000439: January 30, 2020
p.000439: 72 The comma is so in law. See the amendment made by section 142(a)(1) of Public Law 107– 188 (116 Stat. 626).
p.000439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000439:
p.000439:
p.000439:
p.000439:
p.000439:
p.000439:
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p.000439:
p.000439: C:\XML\SSA-MERGED.XML
p.000439:
p.000439:
p.000441: 441
p.000441: PUBLIC HEALTH SERVICE ACT
p.000441: Sec. 363
p.000441:
p.000441: applicable only to individuals coming into a State or possession from a foreign country or a possession.
p.000441: (d)(1) Regulations prescribed under this section may provide for the apprehension and examination of any
p.000441: individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be
p.000441: moving or about to move from a State to an- other State; or (B) to be a probable source of infection
p.000441: to individ- uals who, while infected with such disease in a qualifying stage, will be moving from a State
p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
...

p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
p.000441: prehension and examination, in time of war, of any individual rea- sonably believed (1) to be infected with such
p.000441: disease and (2) to be a probable source of infection to members of the armed forces of the
p.000441:
p.000441:
p.000441:
p.000441:
p.000441: January 30, 2020
p.000441: 73 Under section 3 of Public Law 239, 80th Congress, the date of July 25, 1947, is deemed, for purposes
p.000441: of this section, to be the date of termination of ‘‘any state of war heretofore declared by the Congress’’.
p.000441: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000441:
p.000441:
p.000441:
p.000441:
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p.000441:
p.000441:
p.000441: C:\XML\SSA-MERGED.XML
p.000441:
p.000441: Sec. 364 PUBLIC HEALTH SERVICE ACT 442
p.000441:
p.000441: United States or to individuals engaged in the production or trans- portation of arms, munitions, ships, food,
p.000441: clothing, or other supplies for the armed forces. Such regulations may provide that if upon ex- amination any such
p.000441: individual is found to be so infected, he may be detained for such time and in such manner as may be
p.000441: reason- ably necessary.
p.000441: QUARANTINE STATIONS
p.000441: SEC. 364. ø267¿ (a) Except as provided in title II of the Act of June 15, 1917, as amended (U.S.C., 1940
p.000441: edition, title 50, secs. 191–194), 74 the Surgeon General shall control, direct, and manage all United States
p.000441: quarantine stations, grounds, and anchorages, designate their boundaries, and designate the quarantine
p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
p.000441: darkness. No vessel shall be required to undergo quar- antine inspection during the hours of darkness,
...

Political / person under arrest

Searching for indicator arrest:

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p.000017: persons, the typical number of employees and visitors in the buildings, the extent of the need for
p.000017: security measures re- garding the buildings, buildings or portions of buildings in which there are special
p.000017: circumstances such as high electrical voltage or extreme heat or cold, and such other factors as the Secretary
p.000017: deter- mines to be appropriate.
p.000017: (b) RELATED RECOMMENDATIONS.—The Secretary shall publish in the Federal Register the recommendations
p.000017: of the Secretary on the appropriate implementation of the placement of automated ex- ternal defibrillator devices
p.000017: under subsection (a), including proce- dures for the following:
p.000017: (1) Implementing appropriate training courses in the use of such devices, including the role of
p.000017: cardiopulmonary resus- citation.
p.000017: (2) Proper maintenance and testing of the devices.
p.000017: (3) Ensuring coordination with appropriate licensed profes- sionals in the oversight of training of the devices.
p.000017: (4) Ensuring coordination with local emergency medical systems regarding the placement and incidents of
p.000017: use of the devices.
p.000017: (c) CONSULTATIONS; CONSIDERATION OF CERTAIN RECOMMENDA-
p.000017: TIONS.—In carrying out this section, the Secretary shall—
p.000017: (1) consult with appropriate public and private entities;
p.000017: (2) consider the recommendations of national and local public-health organizations for improving the
p.000017: survival rates of individuals who experience cardiac arrest in nonhospital set- tings by minimizing the
p.000017: time elapsing between the onset of
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 20 Public Law 105–12 (111 Stat. 23).
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 57 PUBLIC HEALTH SERVICE ACT Sec. 248
p.000017:
p.000017: cardiac arrest and the initial medical response, including defibrillation as necessary; and
p.000017: (3) consult with and counsel other Federal agencies where such devices are to be used.
p.000017: (d) DATE CERTAIN FOR ESTABLISHING GUIDELINES AND REC- OMMENDATIONS.—The Secretary shall comply with
p.000017: this section not later than 180 days after the date of the enactment of the Cardiac Arrest Survival Act of 2000.
p.000017: (e) DEFINITIONS.—For purposes of this section:
p.000017: (1) The term ‘‘automated external defibrillator device’’ has the meaning given such term in section 248.
p.000017: (2) The term ‘‘Federal building’’ includes a building or por- tion of a building leased or rented by a Federal agency,
p.000017: and in- cludes buildings on military installations of the United States.
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017: LIABILITY REGARDING EMERGENCY USE OF AUTOMATED EXTERNAL DEFIBRILLATORS
p.000017: SEC. 248. ø238q¿ (a) GOOD SAMARITAN PROTECTIONS REGARD-
p.000017: ING AEDS.—Except as provided in subsection (b), any person who uses or attempts to use an automated
p.000017: external defibrillator device on a victim of a perceived medical emergency is immune from civil liability for any
p.000017: harm resulting from the use or attempted use of such device; and in addition, any person who acquired
p.000017: the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device—
...

p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
p.000017:
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p.000017: January 30, 2020
p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
p.000017: (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the
p.000017: manufac- turers of the devices;
p.000017: (4) by providing training to members of the public in cardiopulmonary resuscitation and automated
p.000017: external defibrillation;
p.000017: (5) by integrating the emergency medical services system with the public access defibrillation programs so
p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
...

p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) shall—
p.000017: (A) describe the comprehensive public access defibrillation program to be funded with the
p.000017: grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to
p.000017: cardiac ar- rest victims in the community;
p.000017: (B) contain procedures for implementing appropriate nationally recognized training courses in
p.000017: performing cardiopulmonary resuscitation and the use of automated external defibrillators;
p.000017: (C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with
p.000017: the local emergency medical services system in the over- sight of training and notification of incidents of the
p.000017: use of the automated external defibrillators;
p.000017: (D) contain procedures for proper maintenance and testing of the automated external defibrillators,
p.000017: according to the labeling of the manufacturer;
p.000017: (E) contain procedures for ensuring notification of local emergency medical services system personnel, including
p.000017: dispatchers, of the location and type of devices used in the public access defibrillation program; and
p.000017: (F) provide for the collection of data regarding the ef- fectiveness of the public access defibrillation
p.000017: program to be funded with the grant in affecting the out-of-hospital car- diac arrest survival rate.
p.000017: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated
p.000017: $25,000,000 for for 6 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts
p.000017: received under a grant awarded under this section may be used for administrative expenses.
p.000017: SEC. 313. ø245¿ PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal
p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
p.000017:
p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
p.000017: providing pub- lic access to automated external defibrillation; and
p.000017: (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded
p.000017: with the grant in—
p.000017: (i) providing emergency cardiopulmonary resus- citation and automated external defibrillation to car- diac
p.000017: arrest victims in the setting served by the dem- onstration project; and
p.000017: (ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000017: $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received
p.000017: under a grant awarded under this section may be used for administrative expenses.
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: Sec. 314 PUBLIC HEALTH SERVICE ACT 94
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p.000017: January 30, 2020
p.000017:
p.000017: GRANTS FOR COMPREHENSIVE HEALTH PLANNING AND PUBLIC HEALTH SERVICES
p.000017: Grants to States for Comprehensive State Health Planning SEC. 314. ø246¿ (a)(1) AUTHORIZATION.—In order to assist
p.000017: the
...

p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
p.000833:
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p.000833: January 30, 2020
p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000833:
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p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
p.000891: (2) create or expand community-based mental health and co-occurring mental illness and substance use disorder
p.000891: services to accommodate the diversion program;
p.000891: (3) train professionals involved in the system of care, and law enforcement officers, attorneys, and judges;
p.000891: (4) provide community outreach and crisis intervention;
p.000891: and
p.000891: (5) develop programs to divert individuals prior to booking
p.000891:
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p.000891: January 30, 2020
p.000891: or arrest.
p.000891: (f) FEDERAL SHARE.—
p.000891: (1) IN GENERAL.—The Secretary shall pay to a State, polit- ical subdivision of a State, Indian tribe, or tribal
p.000891: organization receiving a grant under subsection (a) the Federal share of the cost of activities described in the
p.000891: application.
p.000891: (2) FEDERAL SHARE.—The Federal share of a grant made under this section shall not exceed 75 percent of the
p.000891: total cost of the program carried out by the State, political subdivision of a State, Indian tribe, or tribal
p.000891: organization. Such share shall be used for new expenses of the program carried out by such State, political
p.000891: subdivision of a State, Indian tribe, or tribal or- ganization.
p.000891: (3) NON-FEDERAL SHARE.—The non-Federal share of pay- ments made under this section may be made in cash or in kind
p.000891: fairly evaluated, including planned equipment or services. The Secretary may waive the requirement of matching
p.000891: contribu- tions.
p.000891: (g) GEOGRAPHIC DISTRIBUTION.—The Secretary shall ensure that such grants awarded under subsection (a) are
p.000891: equitably dis-
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: 893
p.000893: PUBLIC HEALTH SERVICE ACT
p.000893: Sec. 520I
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p.001203: (2) shall ensure that the activities of the Program are co- ordinated among such agencies; and
p.001203: (3) shall, as appropriate, provide for collaboration among such agencies in carrying out such activities.
p.001203: (d) CERTAIN ACTIVITIES OF PROGRAM.—The Program shall in- clude—
p.001203: (1) studies with respect to all phases of trauma care, in- cluding prehospital, resuscitation, surgical
p.001203: intervention, critical care, infection control, wound healing, nutritional care and support, and medical
p.001203: rehabilitation care;
p.001203: (2) basic and clinical research regarding the response of the body to trauma and the acute treatment and
p.001203: medical reha- bilitation of individuals who are the victims of trauma;
p.001203: (3) basic and clinical research regarding trauma care for pediatric and geriatric patients; and
p.001203: (4) the authority to make awards of grants or contracts to public or nonprofit private entities for the conduct of
p.001203: basic and applied research regarding traumatic brain injury, which re- search may include—
p.001203: (A) the development of new methods and modalities for the more effective diagnosis, measurement of degree of
p.001203: brain injury, post-injury monitoring and prognostic assess- ment of head injury for acute, subacute and later
p.001203: phases of care;
p.001203: (B) the development, modification and evaluation of therapies that retard, prevent or reverse brain damage
p.001203: after acute head injury 3, that arrest further deterioration following injury and that provide the
p.001203: restitution of func- tion for individuals with long-term injuries;
p.001203: (C) the development of research on a continuum of care from acute care through rehabilitation, designed,
p.001203: to the extent practicable, to integrate rehabilitation and long- term outcome evaluation with acute care research;
p.001203: (D) the development of programs that increase the participation of academic centers of excellence in brain in-
p.001203:
p.001203:
p.001203:
p.001203:
p.001203:
p.001203: January 30, 2020
p.001203: 3 Section 1303(a)(2) of Public Law 106–310 (114 Stat. 1138) provides that subparagraph (B) is amended by
p.001203: striking ‘‘acute injury’’ and inserting ‘‘acute brain injury’’. The amendment cannot be executed because the term
p.001203: to be struck does not appear in subparagraph (B). (Compare ‘‘acute injury’’ and ‘‘acute head injury’’.)
p.001203: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001203:
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p.001205: 1205
p.001205: PUBLIC HEALTH SERVICE ACT
p.001205: Sec. 1261
p.001205:
p.001205: jury treatment and rehabilitation research and training; and
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p.001369: A. Anaphylaxis or anaphylactic
p.001369: shock 24 hours
p.001369: B. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: (b) QUALIFICATIONS AND AIDS TO INTERPRETATION.—The fol- lowing qualifications and aids to interpretation
p.001369: shall apply to the Vaccine Injury Table in subsection (a):
p.001369: (1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as
p.001369: decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning
p.001369: pale white or blue, un- responsiveness to environmental stimuli, depression of con-
p.001369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001369:
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p.001369:
p.001369: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1370
p.001369: sciousness, loss of consciousness, prolonged sleeping with dif- ficulty arousing, or cardiovascular or
p.001369: respiratory arrest.
p.001369: (2) A petitioner may be considered to have suffered a resid- ual seizure disorder if the petitioner did not suffer a
p.001369: seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit
p.001369: before the first seizure or convulsion after the administration of the vaccine involved and if—
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p.001369: January 30, 2020
p.001369: (A) in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure
p.001369: or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions
p.001369: occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a
p.001369: fever of less than 102 degrees Fahrenheit, and
p.001369: (B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after
p.001369: administration of the vaccine and 2 or more seizures or convulsions oc- curred within 1 year after the
p.001369: administration of the vac- cine which were unaccompanied by fever or accompanied by a fever of less than 102
p.001369: degrees Fahrenheit.
p.001369: (3)(A) The term ‘‘encephalopathy’’ means any significant acquired abnormality of, or injury to, or impairment of
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p.000001: (2) In providing a health service to an individual, a health care practitioner shall for purposes of this
p.000001: subsection be considered to
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 34
p.000001: be a free clinic health professional if the following conditions are met:
p.000001:
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p.000001: January 30, 2020
p.000001: (A) The service is provided to the individual at a free clin- ic, or through offsite programs or events carried out by
p.000001: the free clinic.
p.000001: (B) The free clinic is sponsoring the health care practi- tioner pursuant to paragraph (5)(C).
p.000001: (C) The service is a qualifying health service (as defined in paragraph (4)).
p.000001: (D) Neither the health care practitioner nor the free clinic receives any compensation for the service from the
p.000001: individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or
p.000001: under any Federal or State health benefits program). With respect to compliance with such condition:
p.000001: (i) The health care practitioner may receive repayment from the free clinic for reasonable expenses incurred by
p.000001: the health care practitioner in the provision of the service to the individual.
p.000001: (ii) The free clinic may accept voluntary donations for the provision of the service by the health care practitioner to
p.000001: the individual.
p.000001: (E) Before the service is provided, the health care practi- tioner or the free clinic provides written
p.000001: notice to the indi- vidual of the extent to which the legal liability of the health care practitioner
p.000001: is limited pursuant to this subsection (or in the case of an emergency, the written notice is provided to the
p.000001: individual as soon after the emergency as is practicable). If the individual is a minor or is otherwise legally
p.000001: incompetent, the condition under this subparagraph is that the written notice be provided to a legal guardian or other
p.000001: person with legal respon- sibility for the care of the individual.
p.000001: (F) At the time the service is provided, the health care practitioner is licensed or certified in accordance
p.000001: with applica- ble law regarding the provision of the service.
p.000001: (3)(A) For purposes of this subsection, the term ‘‘free clinic’’ means a health care facility operated by a
p.000001: nonprofit private entity meeting the following requirements:
p.000001: (i) The entity does not, in providing health services through the facility, accept reimbursement
p.000001: from any third- party payor (including reimbursement under any insurance policy or health plan, or under
p.000001: any Federal or State health benefits program).
p.000001: (ii) The entity, in providing health services through the fa- cility, either does not impose charges on the
p.000001: individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved
p.000001: to pay the charge.
p.000001: (iii) The entity is licensed or certified in accordance with applicable law regarding the provision of health
p.000001: services.
p.000001: (B) With respect to compliance with the conditions under sub- paragraph (A), the entity involved may accept voluntary
p.000001: donations for the provision of services.
p.000001: (4) For purposes of this subsection, the term ‘‘qualifying health service’’ means any medical assistance required or
p.000001: authorized to be
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 35 PUBLIC HEALTH SERVICE ACT Sec. 224
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p.000001: January 30, 2020
p.000001: (4) CERTIFICATION OF ACTION BY ATTORNEY GENERAL.— Subsection (c) applies to actions under this subsection,
p.000001: subject to the following provisions:
p.000001: (A) NATURE OF CERTIFICATION.—The certification by the Attorney General that is the basis for deeming
p.000001: an ac- tion or proceeding to be against the United States, and for removing an action or proceeding from a
p.000001: State court, is a certification that the action or proceeding is against a cov- ered person and is based upon
p.000001: a claim alleging personal injury or death arising out of the administration of a cov- ered countermeasure.
p.000001: (B) CERTIFICATION OF ATTORNEY GENERAL CONCLU- SIVE.—The certification of the Attorney General of
p.000001: the facts specified in subparagraph (A) shall conclusively es- tablish such facts for purposes of
p.000001: jurisdiction pursuant to this subsection.
p.000001: (5) COVERED PERSON TO COOPERATE WITH UNITED STATES.—
p.000001: (A) IN GENERAL.—A covered person shall cooperate with the United States in the processing and defense of
p.000001: a claim or action under this subsection based upon alleged acts or omissions of such person.
p.000001: (B) CONSEQUENCES OF FAILURE TO COOPERATE.—Upon the motion of the United States or any other party and
p.000001: upon finding that such person has failed to so cooperate—
p.000001: (i) the court shall substitute such person as the party defendant in place of the United States and,
p.000001: upon motion, shall remand any such suit to the court in which it was instituted if it appears that
p.000001: the court lacks subject matter jurisdiction;
p.000001: (ii) the United States shall not be liable based on the acts or omissions of such person; and
p.000001: (iii) the Attorney General shall not be obligated to defend such action.
p.000001: (6) RECOURSE AGAINST COVERED PERSON IN CASE OF GROSS MISCONDUCT OR CONTRACT VIOLATION.—
p.000001: (A) IN GENERAL.—Should payment be made by the United States to any claimant bringing a claim under this
p.000001: subsection, either by way of administrative determination, settlement, or court judgment, the United States
p.000001: shall have, notwithstanding any provision of State law, the right to recover for that portion of the damages so
p.000001: awarded or paid, as well as interest and any costs of litigation, result- ing from the failure of any covered person
p.000001: to carry out any obligation or responsibility assumed by such person under a contract with the United States or from
p.000001: any grossly neg- ligent, reckless, or illegal conduct or willful misconduct on the part of such person.
p.000001: (B) VENUE.—The United States may maintain an ac- tion under this paragraph against such person in the
p.000001: dis- trict court of the United States in which such person re- sides or has its principal place of business.
p.000001: (7) DEFINITIONS.—As used in this subsection, terms have the following meanings:
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: subsection be considered to be a health professional volunteer at an entity described in sub- section
p.000001: (g)(4) if the following conditions are met:
p.000001: (A) The service is provided to the individual at the facili- ties of an entity described in subsection
p.000001: (g)(4), or through off- site programs or events carried out by the entity.
p.000001:
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p.000001: January 30, 2020
p.000001: 14 Subparagraph (C) is shown according to the probable intent of the Congress. In amending the
p.000001: subparagraph to create a clause (i), section 3(g) of Public Law 108–20 (117 Stat. 648) pro- vided that
p.000001: the subparagraph is amended by redesignating certain words ‘‘as clause (i) and in- denting accordingly’’.
p.000001: The use in the amendatory instructions of the word ‘‘accordingly’’ requires the exercise of editorial judgment.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 42
p.000001:
p.000001: (B) The entity is sponsoring the health care practitioner pursuant to paragraph (3)(B).
p.000001: (C) The health care practitioner does not receive any com- pensation for the service from the individual, the
p.000001: entity de- scribed in subsection (g)(4), or any third-party payer (including reimbursement under any insurance
p.000001: policy or health plan, or under any Federal or State health benefits program), except that the health
p.000001: care practitioner may receive repayment from the entity described in subsection (g)(4) for reasonable ex-
p.000001: penses incurred by the health care practitioner in the provision of the service to the individual, which may
p.000001: include travel ex- penses to or from the site of services.
p.000001: (D) Before the service is provided, the health care practi- tioner or the entity described in subsection
p.000001: (g)(4) posts a clear and conspicuous notice at the site where the service is provided of the extent to which the
p.000001: legal liability of the health care practitioner is limited pursuant to this subsection.
p.000001: (E) At the time the service is provided, the health care practitioner is licensed or certified in accordance
p.000001: with applica- ble Federal and State laws regarding the provision of the serv- ice.
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p.000001: (F) At the time the service is provided, the entity described in subsection (g)(4) maintains relevant
p.000001: documentation certi- fying that the health care practitioner meets the requirements of this subsection.
p.000001: (3) Subsection (g) (other than paragraphs (3) and (5)) and sub- sections (h), (i), and (l) apply to a health care
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p.000017: respect to the injury involved an eligible in- dividual under the table as in effect before the amendment but who with
p.000017: respect to such injury is an eligible individual under the table as amended. With respect to a request for benefits or
p.000017: compensation under this part by an individual who becomes an eligible individual as described in the preceding
p.000017: sentence, the Secretary may not provide such benefits or compensation un- less the request (or amendment
p.000017: to a request, as applicable) is filed before the expiration of one year after the effective date of the
p.000017: amendment to the table in the case of an individual to whom the vaccine was administered and before
p.000017: the expiration of two years after such effective date in the case of a request based on accidental
p.000017: vaccinia inoculation.
p.000017: SEC. 264. ø239c¿ MEDICAL BENEFITS.
p.000017: (a) IN GENERAL.—Subject to the succeeding provisions of this section, the Secretary shall make payment or
p.000017: reimbursement for medical items and services as reasonable and necessary to treat a covered injury of an
p.000017: eligible individual, including the services, ap- pliances, and supplies prescribed or recommended by a
p.000017: qualified physician, which the Secretary considers likely to cure, give relief, reduce the degree or the
p.000017: period of disability, or aid in lessening the amount of monthly compensation.
p.000017: (b) BENEFITS SECONDARY TO OTHER COVERAGE.—Payment or reimbursement for services or benefits under subsection
p.000017: (a) shall be secondary to any obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insur- ance carrier, or employer) under any other provision of law or con- tractual
p.000017: agreement, to pay for or provide such services or benefits.
p.000017: SEC. 265. ø239d¿ COMPENSATION FOR LOST EMPLOYMENT INCOME.
p.000017: (a) IN GENERAL.—Subject to the succeeding provisions of this section, the Secretary shall provide compensation
p.000017: to an eligible in- dividual for loss of employment income (based on such income at the time of injury)
p.000017: incurred as a result of a covered injury, at the rate specified in subsection (b).
p.000017: (b) AMOUNT OF COMPENSATION.—
p.000017: (1) IN GENERAL.—Compensation under subsection (a) shall be at the rate of 662⁄3 percent of the relevant pay period
p.000017: (week- ly, monthly, or otherwise), except as provided in paragraph (2).
p.000017: (2) AUGMENTED COMPENSATION FOR DEPENDENTS.—If an el- igible individual has one or more dependents, the basic
p.000017: com- pensation for loss of employment income as described in para- graph (1) shall be augmented at the rate of 81⁄3
p.000017: percent.
p.000017: (3) CONSIDERATION OF OTHER PROGRAMS.—
p.000017: (A) IN GENERAL.—The Secretary may consider the pro- visions of sections 8114, 8115, and 8146a of title 5, United States
p.000017: Code, and any implementing regulations, in deter- mining the amount of payment under subsection (a) and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 265 PUBLIC HEALTH SERVICE ACT 64
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p.000017: the circumstances under which such payments are reason- able and necessary.
p.000017: (B) MINORS.—With respect to an eligible individual who is a minor, the Secretary may consider the provisions of
p.000017: section 8113 of title 5, United States Code, and any im- plementing regulations, in determining the amount of pay- ment
p.000017: under subsection (a) and the circumstances under which such payments are reasonable and necessary.
p.000017: (4) TREATMENT OF SELF-EMPLOYMENT INCOME.—For pur- poses of this section, the term ‘‘employment income’’
p.000017: includes income from self-employment.
p.000017: (c) LIMITATIONS.—
p.000017: (1) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (A) IN GENERAL.—Any compensation under subsection
p.000017: (a) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: gov- ernmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to
p.000017: pay com- pensation for loss of employment income or to provide dis- ability or retirement benefits.
p.000017: (B) RELATION TO OTHER OBLIGATIONS.—Compensation under subsection (a) shall not be made to an eligible indi- vidual
p.000017: to the extent that the total of amounts paid to the individual under such subsection and under the other
p.000017: obli- gations referred to in subparagraph (A) is an amount that exceeds the rate specified in subsection (b)(1). If
p.000017: under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this
p.000017: paragraph, be deemed to be received over multiple years rather than received in a single year. The
p.000017: Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple
p.000017: years.
p.000017: (2) NO BENEFITS IN CASE OF DEATH.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employ- ment income subsequent to the receipt, by the survivor or sur- vivors of an eligible individual, of
p.000017: benefits under section 266 for death.
p.000017: (3) LIMIT ON TOTAL BENEFITS.—
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B)—
p.000017: (i) total compensation paid to an individual under subsection (a) shall not exceed $50,000 for any year; and
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p.000017: (ii) the lifetime total of such compensation for the individual may not exceed an amount equal to the amount
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p.000017: (b) ELECTION IN CASE OF DEPENDENTS.—
p.000017: (1) IN GENERAL.—In the case of an eligible individual whose death is determined to have resulted from a
p.000017: covered in- jury or injuries, if the individual had one or more dependents under the age of 18, the legal
p.000017: guardian of the dependents may, in lieu of the death benefit under subsection (a), elect to re- ceive on
p.000017: behalf of the aggregate of such dependents payments in accordance with this subsection. An election under
p.000017: the pre- ceding sentence is effective in lieu of a request under sub- section (a) by an individual who
p.000017: is not the legal guardian of such dependents.
p.000017: (2) AMOUNT OF PAYMENTS.—Payments under paragraph (1) with respect to an eligible individual described in such
p.000017: para- graph shall be made as if such individual were an eligible indi- vidual to whom compensation would be paid
p.000017: under subsection
p.000017: (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such
p.000017: individual con- sidered to be an eligible individual described in subsection (c)(3)(B) of such section.
p.000017: (3) LIMITATIONS.—
p.000017: (A) AGE OF DEPENDENTS.—No payments may be made under paragraph (1) once the youngest of the dependents involved
p.000017: reaches the age of 18.
p.000017: (B) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (i) IN GENERAL.—Any payment under paragraph
p.000017: (1) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insurance carrier, or em- ployer), under any other law or contractual agreement, to pay
p.000017: compensation for loss of employment income or to provide disability benefits, retirement benefits, life insurance
p.000017: benefits on behalf of dependents under the age of 18, or death benefits.
p.000017: (ii) RELATION TO OTHER OBLIGATIONS.—Payments under paragraph (1) shall not be made to with respect to an eligible
p.000017: individual to the extent that the total of amounts paid with respect to the individual under such paragraph
p.000017: and under the other obligations re- ferred to in clause (i) is an amount that exceeds the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 67 PUBLIC HEALTH SERVICE ACT Sec. 271
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p.000017: rate of payment that applies under paragraph (2). If under any such other obligation a lump-sum payment is
p.000017: made, such payment shall, for purposes of this sub- paragraph, be deemed to be received over multiple years
p.000017: rather than received in a single year. The Sec- retary may, in the discretion of the Secretary, deter-
p.000017: mine how to apportion such payment over multiple years.
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p.000105: activities in the area.
p.000105: (3) PROVISION OF ALL SERVICES AND ACTIVITIES THROUGH EACH GRANTEE.—In making grants under paragraph (1),
p.000105: the Secretary shall ensure that each of the activities described in such paragraph is provided through
p.000105: each grantee under such paragraph. The Secretary may authorize such a grantee to pro- vide the services and
p.000105: activities directly, or through arrange- ments with other providers.
p.000105: (b) STATUS AS MEDICAID PROVIDER.—
p.000105: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless, in the
p.000105: case of any service described in such subsection that is made avail- able pursuant to the State plan approved under
p.000105: title XIX of the Social Security Act for the State involved—
p.000105: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.000105: agreement under the State plan and is qualified to receive payments under such plan; or
p.000105: (B) the applicant will enter into an agreement with a provider under which the provider will provide the
p.000105: service, and the provider has entered into such a participation agreement and is qualified to receive such
p.000105: payments.
p.000105: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.000105: (A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision
p.000105: of services, the requirement established in such paragraph regarding a participation agreement shall be waived by
p.000105: the Secretary if the provider does not, in providing health care services, impose a charge or accept
p.000105: reimbursement avail- able from any third-party payor, including reimbursement under any insurance policy or
p.000105: under any Federal or State health benefits plan.
p.000105: (B) A determination by the Secretary of whether a pro- vider referred to in subparagraph (A) meets the criteria for a
p.000105: waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary dona-
p.000105: tions regarding the provision of services to the public.
p.000105: (c) PRIORITY IN MAKING GRANTS.—In making grants under sub- section (a), the Secretary shall give priority to
p.000105: applications for pro- grams that will serve areas with a high incidence of elevated blood lead levels in infants and
p.000105: children.
p.000105: (d) GRANT APPLICATION.—No grant may be made under sub- section (a), unless an application therefor has
p.000105: been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be
p.000105: submitted in such manner as the Secretary shall prescribe and shall include each of the following:
p.000105: (1) A complete description of the program which is to be provided by or through the applicant.
p.000105: (2) Assurances satisfactory to the Secretary that the pro- gram to be provided under the grant applied
p.000105: for will include educational programs designed to—
p.000105: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000225: PUBLIC HEALTH SERVICE ACT
p.000225: Sec. 319F–3
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p.000225: (i) before each covered person sued has had a rea- sonable opportunity to file a motion to dismiss;
p.000225: (ii) in the event such a motion is filed, before the court has ruled on such motion; and
p.000225: (iii) in the event a covered person files an inter- locutory appeal from the denial of such a motion,
p.000225: be- fore the court of appeals has ruled on such appeal.
p.000225: (B) STANDARD.—Notwithstanding any other provision of law, the court in an action under subsection (d)
p.000225: shall permit discovery only with respect to matters directly re- lated to material issues contested in
p.000225: such action, and the court shall compel a response to a discovery request (in- cluding a request for
p.000225: admission, an interrogatory, a re- quest for production of documents, or any other form of discovery
p.000225: request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party
p.000225: needs the information sought to prove or defend as to a material issue contested in such action and that the
p.000225: likely benefits of a response to such request equal or exceed the burden or cost for the responding party of
p.000225: providing such response.
p.000225: (7) REDUCTION IN AWARD OF DAMAGES FOR COLLATERAL SOURCE BENEFITS.—
p.000225: (A) IN GENERAL.—In an action under subsection (d), the amount of an award of damages that would otherwise be
p.000225: made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff.
p.000225: (B) PROVIDER OF COLLATERAL SOURCE BENEFITS NOT TO HAVE LIEN OR SUBROGATION.—No provider of collateral
p.000225: source benefits shall recover any amount against the plain- tiff or receive any lien or credit against the
p.000225: plaintiff’s re- covery or be equitably or legally subrogated to the right of the plaintiff in an action under
p.000225: subsection (d).
p.000225: (C) COLLATERAL SOURCE BENEFIT DEFINED.—For pur- poses of this paragraph, the term ‘‘collateral source ben-
p.000225: efit’’ means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any
p.000225: service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as
p.000225: a result of the injury or wrongful death, pursuant to—
p.000225: (i) any State or Federal health, sickness, income- disability, accident, or workers’ compensation law;
p.000225: (ii) any health, sickness, income-disability, or acci- dent insurance that provides health benefits or in-
p.000225: come-disability coverage;
p.000225: (iii) any contract or agreement of any group, orga- nization, partnership, or corporation to provide, pay for,
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p.000225: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 226
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p.000225:
p.000225: bility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term ‘‘noneconomic
p.000225: damages’’ means damages for losses for physical and emotional pain, suffering, inconvenience, physical
p.000225: impairment, mental anguish, disfigure- ment, loss of enjoyment of life, loss of society and companion- ship,
p.000225: loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
p.000225: (9) RULE 11 SANCTIONS.—Whenever a district court of the United States determines that there has been a
p.000225: violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court
p.000225: shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are respon- sible for
p.000225: the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the
p.000225: reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that
p.000225: is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter
p.000225: repetition of such conduct or comparable conduct by others similarly situated, and to compensate the
p.000225: party or parties injured by such conduct.
p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
p.000225: right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law
p.000225: or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United
p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
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p.000263: PUBLIC HEALTH SERVICE ACT
p.000263: Sec. 330
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p.000263: (3) CONSTRUCTION.—The Secretary may award grants which may be used to pay the costs associated with expanding
p.000263: and modernizing existing buildings or constructing new build- ings (including the costs of amortizing the
p.000263: principal of, and paying the interest on, loans) for projects approved prior to Oc- tober 1, 1996.
p.000263: (4) LIMITATION.—Not more than two grants may be made under subparagraph (B) of paragraph (1) for the
p.000263: same entity.
p.000263: (5) AMOUNT.—
p.000263: (A) IN GENERAL.—The amount of any grant made in any fiscal year under subparagraphs (A) and (B) of
p.000263: para- graph (1) to a health center shall be determined by the Secretary, but may not exceed the amount
p.000263: by which the costs of operation of the center in such fiscal year exceed the total of—
p.000263: (i) State, local, and other operational funding pro- vided to the center; and
p.000263: (ii) the fees, premiums, and third-party reimburse- ments, which the center may reasonably be expected to
p.000263: receive for its operations in such fiscal year.
p.000263: (B) NETWORKS.—The total amount of grant funds made available for any fiscal year under paragraph
p.000263: (1)(C) to a health center or to a network shall be determined by the Secretary, but may not exceed 2 percent of
p.000263: the total amount appropriated under this section for such fiscal year.
p.000263: (C) PAYMENTS.—Payments under grants under sub- paragraph (A) or (B) of paragraph (1) shall be made in ad- vance
p.000263: or by way of reimbursement and in such install- ments as the Secretary finds necessary and adjustments
p.000263: may be made for overpayments or underpayments.
p.000263: (D) USE OF NONGRANT FUNDS.—Nongrant funds de- scribed in clauses (i) and (ii) of subparagraph (A),
p.000263: includ- ing any such funds in excess of those originally expected, shall be used as permitted under this
p.000263: section, and may be used for such other purposes as are not specifically prohib- ited under this section if such
p.000263: use furthers the objectives of the project.
p.000263: (6) NEW ACCESS POINTS AND EXPANDED SERVICES.—
p.000263: (A) APPROVAL OF NEW ACCESS POINTS.—
p.000263: (i) IN GENERAL.—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph
p.000263: (1) to establish new delivery sites.
p.000263: (ii) SPECIAL CONSIDERATION.—In carrying out clause (i), the Secretary may give special consideration to
p.000263: applicants that have demonstrated the new delivery site will be located within a sparsely populated area, or
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p.000295: PUBLIC HEALTH SERVICE ACT
p.000295: Sec. 330I
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p.000295: tier communities, or medically underserved areas, or for medically underserved populations; or
p.000295: (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro-
p.000295: viders, in a manner that enhances access to care in the areas and communities, or for the populations,
p.000295: described in clause (i);
p.000295: (D) developing and acquiring instructional program- ming;
p.000295: (E)(i) providing for transmission of medical data, and maintenance of equipment; and
p.000295: (ii) providing for compensation (including travel ex- penses) of specialists, and referring health care
p.000295: providers, who are providing telehealth services through the tele- health network, if no third party
p.000295: payment is available for the telehealth services delivered through the telehealth network;
p.000295: (F) developing projects to use telehealth technology to facilitate collaboration between health care providers;
p.000295: (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the
p.000295: telehealth serv- ices; and
p.000295: (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined
p.000295: by the Secretary.
p.000295: (2) TELEHEALTH RESOURCE CENTERS.—The recipient of a grant under subsection (d)(2) may use funds received
p.000295: through such grant for salaries, equipment, and operating or other costs for—
p.000295: (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care
p.000295: pro- viders and a range of health care entities that provide or will provide telehealth services;
p.000295: (B) disseminating information and research findings related to telehealth services;
p.000295: (C) promoting effective collaboration among telehealth resource centers and the Office;
p.000295: (D) conducting evaluations to determine the best utili- zation of telehealth technologies to meet health care needs;
p.000295: (E) promoting the integration of the technologies used in clinical information systems with other telehealth tech-
p.000295: nologies;
p.000295: (F) fostering the use of telehealth technologies to pro- vide health care information and education for health
p.000295: care providers and consumers in a more effective manner; and
...

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p.000309:
p.000309: Sec. 333 PUBLIC HEALTH SERVICE ACT 310
p.000309:
p.000309: (A) a public or private entity, which is located or has a demonstrated interest in such area, makes
p.000309: application to the Secretary for such assignment;
p.000309: (B) such application has been approved by the Secretary;
p.000309: (C) the entity agrees to comply with the requirements of section 334; and
p.000309: (D) the Secretary has (i) conducted an evaluation of the need and demand for health professional shortage
p.000309: area, the in- tended use of Corps members to be assigned to the area, com- munity support for the assignment of
p.000309: Corps members to the area, the area’s efforts to secure health professional shortage area, and the fiscal
p.000309: management capability of the entity to which Corps members would be assigned and (ii) on the basis of
p.000309: such evaluation has determined that—
p.000309:
p.000309: (I) there is a need and demand for health manpower for the area;
p.000309: (II) there has been appropriate and efficient use of any Corps members previously assigned to the entity for
p.000309: the area;
p.000309: (III) there is general community support for the as- signment of Corps members to the entity;
p.000309: (IV) the area has made unsuccessful efforts to secure health manpower for the area;
p.000309: (V) there is a reasonable prospect of sound fiscal man- agement, including efficient collection of
p.000309: fee-for-service, third-party, and other appropriate funds, by the entity with respect to Corps members
p.000309: assigned to such entity; and
p.000309: (VI) 39 the entity demonstrates willingness to support or facilitate mentorship, professional de- velopment,
p.000309: and training opportunities for Corps members.
p.000309: An application for assignment of a Corps member to a health pro- fessional shortage area shall include a demonstration
p.000309: by the appli- cant that the area or population group to be served by the appli- cant has a shortage of
p.000309: personal health services and that the Corps member will be located so that the member will provide services to the
p.000309: greatest number of persons residing in such area or included in such population group. Such a
p.000309: demonstration shall be made on the basis of the criteria prescribed by the Secretary under section 332(b)
p.000309: and on additional criteria which the Secretary shall pre- scribe to determine if the area or population group
p.000309: to be served by the applicant has a shortage of personal health services.
p.000309: (2) Corps members may be assigned to a Federal health care facility, but only upon the request of the
p.000309: head of the department or agency of which such facility is a part.
p.000309: (3) In approving applications for assignment of members of the Corps the Secretary shall not discriminate against
p.000309: applications from entities which are not receiving Federal financial assistance under this Act. In approving
p.000309: such applications, the Secretary shall give preference to applications in which a nonprofit entity or public
p.000309:
p.000309:
p.000309:
p.000309: January 30, 2020
p.000309: 39 Margin so in law.
p.000309:
p.000309: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000309:
p.000309:
...

p.000315: C:\XML\PHSA.BEL HOUSEP
p.000315:
p.000315:
p.000315: C:\XML\SSA-MERGED.XML
p.000315:
p.000315: Sec. 335 PUBLIC HEALTH SERVICE ACT 316
p.000315:
p.000315: (C) USE OF SCHEDULES.—The entity shall make every reasonable effort to secure from patients fees and
p.000315: pay- ments for services in accordance with such schedules, and fees or payments shall be sufficiently discounted in
p.000315: accord- ance with the schedule described in subparagraph (B).
p.000315: (2) SERVICES TO BENEFICIARIES OF FEDERAL AND FEDER- ALLY ASSISTED PROGRAMS.—In the case of health
p.000315: care services furnished to an individual who is a beneficiary of a program listed in subsection (a)(2), the
p.000315: entity—
p.000315: (A) shall accept an assignment pursuant to section 1842(b)(3)(B)(ii) of the Social Security Act (42
p.000315: U.S.C. 1395u(b)(3)(B)(ii)) with respect to an individual who is a beneficiary under the medicare program; and
p.000315: (B) shall enter into an appropriate agreement with—
p.000315: (i) the State agency administering the program under title XIX of such Act with respect to an indi-
p.000315: vidual who is a beneficiary under the medicaid pro- gram; and
p.000315: (ii) the State agency administering the program under title XXI of such Act with respect to an indi-
p.000315: vidual who is a beneficiary under the State children’s health insurance program.
p.000315: (3) COLLECTION OF PAYMENTS.—The entity shall take rea- sonable and appropriate steps to collect all
p.000315: payments due for health care services provided by the entity, including payments from any third party (including
p.000315: a Federal, State, or local gov- ernment agency and any other third party) that is responsible for part or all of
p.000315: the charge for such services.
p.000315:
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p.000315:
p.000315: January 30, 2020
p.000315: PROVISION OF HEALTH SERVICES BY CORPS MEMBERS
p.000315: SEC. 335. ø254h¿ (a) In providing health services in a health professional shortage area, Corps members
p.000315: shall utilize the tech- niques, facilities, and organizational forms most appropriate for the area, population
p.000315: group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1)
p.000315: to all individuals in, or served by, such health professional shortage area regardless of their ability
p.000315: to pay for the services, and (2) in a manner which is cooperative with other health care providers
p.000315: serving such health professional shortage area.
p.000315: (b)(1) Notwithstanding any other provision of law, the Sec- retary may (A) to the maximum extent feasible make
p.000315: such arrange- ments as he determines necessary to enable Corps members to uti- lize the health facilities in or serving
p.000315: the health professional short- age area in providing health services; (B) make such arrangements as he determines
p.000315: are necessary for the use of equipment and sup- plies of the Service and for the lease or acquisition of other
p.000315: equip- ment and supplies; and (C) secure the permanent or temporary services of physicians, dentists,
...

p.000441: C:\XML\PHSA.BEL HOUSEP
p.000441:
p.000441:
p.000441: C:\XML\SSA-MERGED.XML
p.000441:
p.000441: Sec. 364 PUBLIC HEALTH SERVICE ACT 442
p.000441:
p.000441: United States or to individuals engaged in the production or trans- portation of arms, munitions, ships, food,
p.000441: clothing, or other supplies for the armed forces. Such regulations may provide that if upon ex- amination any such
p.000441: individual is found to be so infected, he may be detained for such time and in such manner as may be
p.000441: reason- ably necessary.
p.000441: QUARANTINE STATIONS
p.000441: SEC. 364. ø267¿ (a) Except as provided in title II of the Act of June 15, 1917, as amended (U.S.C., 1940
p.000441: edition, title 50, secs. 191–194), 74 the Surgeon General shall control, direct, and manage all United States
p.000441: quarantine stations, grounds, and anchorages, designate their boundaries, and designate the quarantine
p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
p.000441: darkness. No vessel shall be required to undergo quar- antine inspection during the hours of darkness,
p.000441: unless the quar- antine officer at such quarantine station shall deem an immediate inspection necessary to protect
p.000441: the public health. Uniformity shall not be required in the hours during which quarantine inspection may
p.000441: be obtained at the various ports of the United States.
p.000441: (c) The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of
p.000441: employees of the United States Public Health Service, Foreign Quarantine Division, per- forming overtime
p.000441: duties including the operation of vessels, in con- nection with the inspection or quarantine treatment of
p.000441: persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or
p.000441: any place subject to the juris- diction thereof, hereinafter referred to as ‘‘employees of the Public Health
p.000441: Service’’, when required to be on duty between the hours of 6 o’clock postmeridian and 6 o’clock antemeridian
...

p.000465: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000465: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000465: subsection (d)(2).
p.000465: (h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE MARROW AND CORD BLOOD.—
p.000465: (1) IN GENERAL.—The Secretary shall establish and main- tain, through a contract or other means
p.000465: determined appro- priate by the Secretary, an office of patient advocacy (in this subsection referred to as
p.000465: the ‘‘Office’’).
p.000465: (2) GENERAL FUNCTIONS.—The Office shall meet the fol- lowing requirements:
p.000465: (A) The Office shall be headed by a director.
p.000465: (B) The Office shall be staffed by individuals with ex- pertise in bone marrow and cord blood therapy covered
p.000465: under the Program.
p.000465: (C) The Office shall operate a system for patient advo- cacy, which shall be separate from mechanisms for donor
p.000465: advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to
p.000465: conduct, a search for a bone marrow donor or cord blood unit.
p.000465: (D) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the
p.000465: patient (or family members, physicians, or other individ- uals acting on behalf of the patient) individualized
p.000465: services with respect to efficiently utilizing the system under para- graphs (1) and (2) of subsection (d) to
p.000465: conduct an ongoing search for a bone marrow donor or cord blood unit and as- sist with information regarding third
p.000465: party payor matters.
p.000465: (E) In carrying out subparagraph (D), the Office shall monitor the system under paragraphs (1) and (2) of sub-
p.000465: section (d) to determine whether the search needs of the patient involved are being met, including with
p.000465: respect to the following:
p.000465: (i) Periodically providing to the patient (or an in- dividual acting on behalf of the patient)
p.000465: information regarding bone marrow donors or cord blood units that are suitably matched to the patient, and other
p.000465: infor-
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000465:
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p.000465:
p.000467: 467
p.000467: PUBLIC HEALTH SERVICE ACT
p.000467: Sec. 379
p.000467:
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p.000467: January 30, 2020
p.000467: mation regarding the progress being made in the search.
p.000467: (ii) Informing the patient (or such other indi- vidual) if the search has been interrupted or
p.000467: discon- tinued.
...

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p.000487:
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p.000487:
p.000487: Sec. 399 PUBLIC HEALTH SERVICE ACT 488
p.000487:
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p.000487: January 30, 2020
p.000487:
p.000487: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000487: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000487: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000487: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
...

p.000493: and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted
p.000493: regarding the pro- mulgation of program guidelines and funding priorities under this section.
p.000493: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000493: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000493: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000493: Social Security Act for the State involved—
p.000493: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000493: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000493: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000493: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000493: such payments.
p.000493: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000493: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000493: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000493: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000493: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000493: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000493: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000493: garding the provision of services to the public.
p.000493: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000493: the appli- cant involved agrees to make available (directly or through agree- ments with other entities) to
p.000493: children of substance abusers each of the following services:
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000493:
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p.000495: 495
p.000495: PUBLIC HEALTH SERVICE ACT
p.000495: Sec. 399A
p.000495:
p.000495: (1) Periodic evaluation of children for developmental, psy- chological, and medical problems.
p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
...

p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
p.000501: (ii) the entity will identify children who may be eli- gible for medical assistance under a State program under
p.000501: title XIX or XXI of the Social Security Act.
p.000501: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision
p.000501: of services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000501: agreement shall be waived by the Secretary if the organization does not, in providing health or mental
p.000501: health services, impose a charge or accept reimbursement available from any third- party payor, including
p.000501: reimbursement under any insurance policy or under any Federal or State health benefits pro- gram.
p.000501: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria
p.000501: for a waiver under such clause shall be made without regard to whether the organization accepts
p.000501: voluntary donations re- garding the provision of services to the public.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000501:
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p.000501: Sec. 399A PUBLIC HEALTH SERVICE ACT 502
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
...

p.000531: Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the
p.000531: National Institutes of Health shall collaborate and consult with—
p.000531: (A) other Federal agencies;
p.000531: (B) State and local agencies, including agencies re- sponsible for early intervention services pursuant to
p.000531: title XIX of the Social Security Act (Medicaid Early and Peri- odic Screening, Diagnosis and Treatment
p.000531: Program); title XXI of the Social Security Act (State Children’s Health In- surance Program); title V of the
p.000531: Social Security Act (Ma- ternal and Child Health Block Grant Program); and part C of the Individuals with
p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
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p.000611: trial to test prototype devices where the primary outcome measure relates to feasibility and not to health
p.000611: outcomes); and
p.000611: (II) a pediatric postmarket surveillance as re- quired under section 522 of the Federal Food, Drug, and Cosmetic
p.000611: Act.
p.000611: (iii) APPLICABLE DRUG CLINICAL TRIAL.—
p.000611: (I) IN GENERAL.—The term ‘‘applicable drug clinical trial’’ means a controlled clinical investiga- tion, other
p.000611: than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act
p.000611: or to section 351 of this Act.
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p.000611: (II) CLINICAL INVESTIGATION.—For purposes of subclause (I), the term ‘‘clinical investigation’’ has the meaning
p.000611: given that term in section 312.3 of title 21, Code of Federal Regulations (or any suc- cessor
p.000611: regulation).
p.000611: (III) PHASE I.—For purposes of subclause (I), the term ‘‘phase I’’ has the meaning given that term in
p.000611: section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
p.000611: (iv) CLINICAL TRIAL INFORMATION.—The term ‘‘clinical trial information’’ means, with respect to an
p.000611: applicable clinical trial, those data elements that the responsible party is required to submit under
p.000611: para- graph (2) or under paragraph (3).
p.000611: (v) COMPLETION DATE.—The term ‘‘completion date’’ means, with respect to an applicable clinical trial,
p.000611: the date that the final subject was examined or
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000611: Sec. 402 PUBLIC HEALTH SERVICE ACT 612
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p.000611: received an intervention for the purposes of final col- lection of data for the primary outcome, whether
p.000611: the clinical trial concluded according to the prespecified protocol or was terminated.
p.000611: (vi) DEVICE.—The term ‘‘device’’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.000611: Cosmetic Act.
p.000611: (vii) DRUG.—The term ‘‘drug’’ means a drug as de- fined in section 201(g) of the Federal Food, Drug, and Cosmetic Act
p.000611: or a biological product as defined in sec- tion 351 of this Act.
p.000611: (viii) ONGOING.—The term ‘‘ongoing’’ means, with respect to a clinical trial of a drug or a device and
p.000611: to a date, that—
p.000611: (I) 1 or more patients is enrolled in the clin- ical trial; and
p.000611: (II) the date is before the completion date of the clinical trial.
p.000611: (ix) RESPONSIBLE PARTY.—The term ‘‘responsible party’’, with respect to a clinical trial of a drug or de- vice,
p.000611: means—
p.000611: (I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.000611: successor regulation)); or
p.000611: (II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con-
p.000611: tractor, or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to
p.000611: and control over the data from the clin- ical trial, has the right to publish the results of the trial,
p.000611: and has the ability to meet all of the re- quirements under this subsection for the submis- sion of clinical
p.000611: trial information.
p.000611: (B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for each
p.000611: appli- cable clinical trial shall submit the identity and contact in- formation of such responsible party to the
p.000611: Secretary at the time of submission of clinical trial information under para- graph (2).
p.000611: (2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.000611: (A) IN GENERAL.—
p.000611: (i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.000611: progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.000611: ance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (re-
p.000611: ferred to in this subsection as the ‘‘registry data bank’’). The Director of NIH shall ensure that the
p.000611: reg- istry data bank is made publicly available through the Internet.
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000611:
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p.000613: 613
p.000613: PUBLIC HEALTH SERVICE ACT
p.000613: Sec. 402
p.000613:
p.000613: (ii) CONTENT.—The clinical trial information re- quired to be submitted under this paragraph for an
p.000613: applicable clinical trial shall include—
p.000613: (I) descriptive information, including—
p.000613: (aa) a brief title, intended for the lay pub-
p.000613: lic;
p.000613: (bb) a brief summary, intended for the lay
p.000613: public;
p.000613: (cc) the primary purpose; (dd) the study design;
p.000613: (ee) for an applicable drug clinical trial, the study phase;
p.000613: (ff) study type;
p.000613: (gg) the primary disease or condition being studied, or the focus of the study;
p.000613: (hh) the intervention name and interven- tion type;
p.000613: (ii) the study start date;
p.000613: (jj) the expected completion date;
p.000613: (kk) the target number of subjects; and (ll) outcomes, including primary and sec-
p.000613: ondary outcome measures;
p.000613: (II) recruitment information, including— (aa) eligibility criteria;
p.000613: (bb) gender; (cc) age limits;
p.000613: (dd) whether the trial accepts healthy vol- unteers;
p.000613: (ee) overall recruitment status; (ff) individual site status; and
p.000613: (gg) in the case of an applicable drug clin- ical trial, if the drug is not approved under section 505 of
p.000613: the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.000613: there is ex- panded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act
p.000613: for those who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such
p.000613: access;
p.000613: (III) location and contact information, includ- ing—
p.000613:
p.000613:
p.000613: and
p.000613: (aa) the name of the sponsor;
p.000613: (bb) the responsible party, by official title;
p.000613: (cc) the facility name and facility contact
p.000613:
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p.000613: January 30, 2020
p.000613: information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.000613: through which such location in- formation may be accessed); and
p.000613: (IV) administrative data (which the Secretary may make publicly available as necessary), includ- ing—
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: (aa) the unique protocol identification number;
p.000613: (bb) other protocol identification numbers, if any; and
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p.000613: descriptors.
p.000613: (II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.000613: (III) The location of the clinical trial.
p.000613: (IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.000613: (V) The study phase of the clinical trial.
p.000613: (VI) The sponsor of the clinical trial, which may be the National Institutes of Health or an- other
p.000613: Federal agency, a private industry source, or a university or other organization.
p.000613: (VII) The recruitment status of the clinical trial.
p.000613: (VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.000613: (ii) ADDITIONAL SEARCHABLE CATEGORY.—Not later than 18 months after the date of the enactment of the Food and Drug
p.000613: Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries
p.000613: of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary
p.000613: or secondary outcome.
p.000613: (iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.000613: registry data bank by such other elements as the Director deems necessary on an ongoing basis.
p.000613: (iv) FORMAT.—The Director of the NIH shall en- sure that the registry data bank is easily used by the public,
p.000613: and that entries are easily compared.
p.000613: (C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.000613: clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
p.000613: ongoing on the date that is 90 days after, the date of the enactment of the Food and
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000615: PUBLIC HEALTH SERVICE ACT
p.000615: Sec. 402
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p.000615: January 30, 2020
p.000615: Drug Administration Amendments Act of 2007, shall sub- mit to the Director of NIH for inclusion in the
p.000615: registry data bank the clinical trial information described in of sub- paragraph (A)(ii) not later than the later of—
p.000615: (i) 90 days after such date of enactment;
p.000615: (ii) 21 days after the first patient is enrolled in such clinical trial; or
p.000615: (iii) in the case of a clinical trial that is not for a serious or life-threatening disease or
p.000615: condition and that is ongoing on such date of enactment, 1 year after such date of enactment.
p.000615: (D) POSTING OF DATA.—
p.000615: (i) APPLICABLE DRUG CLINICAL TRIAL.—The Direc- tor of NIH shall ensure that clinical trial information for
p.000615: an applicable drug clinical trial submitted in ac- cordance with this paragraph is posted in the registry data
p.000615: bank not later than 30 days after such submis- sion.
p.000615: (ii) APPLICABLE DEVICE CLINICAL TRIAL.—The Di- rector of NIH shall ensure that clinical trial informa-
p.000615: tion for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in
p.000615: the registry data bank—
p.000615: (I) not earlier than the date of clearance under section 510(k) of the Federal Food, Drug, and
p.000615: Cosmetic Act, or approval under section 515 or 520(m) of such Act, as applicable, for a device that was
p.000615: not previously cleared or approved, and not later than 30 days after such date, unless the responsible party
p.000615: affirmatively requests that the Director of the National Institutes of Health pub- licly post such clinical
p.000615: trial information for an ap- plicable device clinical trial prior to such date of clearance or approval; or
p.000615: (II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information
p.000615: under paragraph (3)(C) is re- quired to be posted by the Secretary.
p.000615: (iii) OPTION TO MAKE CERTAIN CLINICAL TRIAL IN- FORMATION AVAILABLE EARLIER.—The Director of the National
p.000615: Institutes of Health shall inform responsible parties of the option to request that clinical trial infor- mation
p.000615: for an applicable device clinical trial be pub- licly posted prior to the date of clearance or approval, in
p.000615: accordance with clause (ii)(I).
p.000615: (iv) COMBINATION PRODUCTS.—An applicable clin- ical trial for a product that is a combination of drug,
p.000615: device, or biological product shall be considered—
p.000615: (I) an applicable drug clinical trial, if the Sec- retary determines under section 503(g) of the Fed- eral Food,
p.000615: Drug, and Cosmetic Act that the pri- mary mode of action of such product is that of a drug or
p.000615: biological product; or
p.000615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000619: (5)(C), procedures for quality control, in- cluding using representative samples, with respect to completeness
p.000619: and content of clinical trial infor- mation under this subsection, to help ensure that data elements are not
p.000619: false or misleading and are non-promotional;
p.000619: (IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.000619: if so, how such updates should be tracked;
p.000619: (V) a statement to accompany the entry for an applicable clinical trial when the primary and sec- ondary outcome
p.000619: measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.000619: submission of such informa- tion in paragraph (2)(C); and
p.000619: (VI) additions or modifications to the manner of reporting of the data elements established under
p.000619: subparagraph (C).
p.000619: (vi) CONSIDERATION OF WORLD HEALTH ORGANIZA- TION DATA SET.—The Secretary shall consider the sta- tus of the
p.000619: consensus data elements set for reporting clinical trial results of the World Health Organization when issuing
p.000619: the regulations under this subpara- graph.
p.000619: (vii) PUBLIC MEETING.—The Secretary shall hold a public meeting no later than 18 months after the date of the enactment
p.000619: of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties
p.000619: with regard to the regu- lations to be issued under this subparagraph.
p.000619: (E) SUBMISSION OF RESULTS INFORMATION.—
p.000619: (i) IN GENERAL.—Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an
p.000619: ap- plicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion
p.000619: in the registry and results data bank the clinical trial infor- mation described in subparagraph (C) not later
p.000619: than 1 year, or such other period as may be provided by regu- lation under subparagraph (D), after the earlier of—
p.000619: (I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or
p.000619: (II) the actual date of completion.
p.000619: (ii) CLINICAL TRIALS DESCRIBED.—An applicable clinical trial described in this clause is an
p.000619: applicable clinical trial subject to—
p.000619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000621: PUBLIC HEALTH SERVICE ACT
p.000621: Sec. 402
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p.000621: (I) paragraph (2)(C); and (II)(aa) subparagraph (C); or
p.000621: (bb) the regulations issued under subpara- graph (D).
p.000621: (iii) DELAYED SUBMISSION OF RESULTS WITH CER- TIFICATION.—If the responsible party for an applicable clinical
p.000621: trial submits a certification that clause (iv) or
p.000621: (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in
p.000621: the registry and results data bank the clinical trial infor- mation described in subparagraphs (C) and
p.000621: (D) as re- quired under the applicable clause.
p.000621: (iv) SEEKING INITIAL APPROVAL OF A DRUG OR DE- VICE.—With respect to an applicable clinical trial that is
p.000621: completed before the drug is initially approved under section 505 of the Federal Food, Drug, and Cos- metic
p.000621: Act or initially licensed under section 351 of this Act, or the device is initially cleared under section
p.000621: 510(k) or initially approved under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic
p.000621: Act, the responsible party shall submit to the Director of NIH for inclusion in the registry and results
p.000621: data bank the clinical trial information described in sub- paragraphs (C) and (D) not later than 30
p.000621: days after the drug or device is approved under such section 505, licensed under such section 351, cleared under
p.000621: such section 510(k), or approved under such section 515 or 520(m), as applicable.
p.000621: (v) SEEKING APPROVAL OF A NEW USE FOR THE DRUG OR DEVICE.—
p.000621: (I) IN GENERAL.—With respect to an applica- ble clinical trial where the manufacturer of the drug or
p.000621: device is the sponsor of an applicable clin- ical trial, and such manufacturer has filed, or will file within 1 year,
p.000621: an application seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act, licensing
p.000621: under section 351 of this Act, or clearance under section 510(k), or approval under section 515 or 520(m), of the
p.000621: Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial (which use is not included in
p.000621: the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for
p.000621: inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C)
p.000621: and (D) on the earlier of the date that is 30 days after the date—
p.000621: (aa) the new use of the drug or device is approved under such section 505, licensed under such
p.000621: section 351, cleared under such section 510(k), or approved under such section 515 or 520(m);
p.000621: (bb) the Secretary issues a letter, such as a complete response letter, not approving the
p.000621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000621: Sec. 402 PUBLIC HEALTH SERVICE ACT 622
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p.000621: submission or not clearing the submission, a not approvable letter, or a not substantially equivalent
p.000621: letter for the new use of the drug or device under such section 505, 351, 510(k), 515, or 520(m); or
p.000621: (cc) except as provided in subclause (III), the application or premarket notification under such
p.000621: section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days.
p.000621: (II) REQUIREMENT THAT EACH CLINICAL TRIAL IN APPLICATION BE TREATED THE SAME.—If a man- ufacturer makes a
p.000621: certification under clause (iii) that this clause applies with respect to a clinical trial, the
p.000621: manufacturer shall make such a certifi- cation with respect to each applicable clinical trial that is required to
p.000621: be submitted in an application or report for licensure, approval, or clearance (under section 351 of
p.000621: this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as
p.000621: applicable) of the use stud- ied in the clinical trial.
p.000621: (III) TWO-YEAR LIMITATION.—The responsible party shall submit to the Director of NIH for in- clusion in
p.000621: the registry and results data bank the clinical trial information subject to subclause (I) on the date that
p.000621: is 2 years after the date a certifi- cation under clause (iii) was made to the Director of NIH, if an action
p.000621: referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
p.000621: (vi) EXTENSIONS.—The Director of NIH may pro- vide an extension of the deadline for submission of
p.000621: clinical trial information under clause (i) if the respon- sible party for the trial submits to the Director a writ-
p.000621: ten request that demonstrates good cause for the ex- tension and provides an estimate of the date on which the
p.000621: information will be submitted. The Director of NIH may grant more than one such extension for a clinical
p.000621: trial.
p.000621: (F) NOTICE TO DIRECTOR OF NIH.—The Commissioner of Food and Drugs shall notify the Director of
p.000621: NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of
p.000621: subparagraph (E)(v)(I) with re- spect to an application or a report that includes a certifi- cation
p.000621: required under paragraph (5)(B) of such action not later than 30 days after such action.
p.000621: (G) POSTING OF DATA.—The Director of NIH shall en- sure that the clinical trial information described in
p.000621: sub- paragraphs (C) and (D) for an applicable clinical trial sub- mitted in accordance with this paragraph is
p.000621: posted pub- licly in the registry and results database not later than 30 days after such submission.
p.000621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000623: 623
p.000623: PUBLIC HEALTH SERVICE ACT
p.000623: Sec. 402
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p.000623: January 30, 2020
p.000623: (H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL RE- SULTS.—The Secretary may waive any applicable require-
p.000623: ments of this paragraph for an applicable clinical trial, upon a written request from the responsible
p.000623: party, if the Secretary determines that extraordinary circumstances justify the waiver and that
p.000623: providing the waiver is con- sistent with the protection of public health, or in the inter- est of national
p.000623: security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in
p.000623: writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was
p.000623: granted.
p.000623: (I) ADVERSE EVENTS.—
p.000623: (i) REGULATIONS.—Not later than 18 months after the date of the enactment of the Food and Drug Ad-
p.000623: ministration Amendments Act of 2007, the Secretary shall by regulation determine the best method for in-
p.000623: cluding in the registry and results data bank appro- priate results information on serious adverse and
p.000623: fre- quent adverse events for applicable clinical trials de- scribed in subparagraph (C) in a manner and
p.000623: form that is useful and not misleading to patients, physi- cians, and scientists.
p.000623: (ii) DEFAULT.—If the Secretary fails to issue the regulation required by clause (i) by the date that is 24
p.000623: months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.000623: clause (iii) shall take effect.
p.000623: (iii) ADDITIONAL ELEMENTS.—Upon the application of clause (ii), the Secretary shall include in the reg-
p.000623: istry and results data bank for applicable clinical trials described in subparagraph (C), in addition to
...

p.000623: (iv) POSTING OF OTHER INFORMATION.—In carrying out clause (iii), the Secretary shall, in consultation with
p.000623: experts in risk communication, post with the ta- bles information to enhance patient understanding and
p.000623: to ensure such tables do not mislead patients or the lay public.
p.000623: (v) RELATION TO SUBPARAGRAPH (C).—Clinical trial information included in the registry and results data
p.000623: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000623:
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p.000623: Sec. 402 PUBLIC HEALTH SERVICE ACT 624
p.000623: bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank
p.000623: pursuant to subparagraph (C).
p.000623: (4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA- TION.—
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p.000623: January 30, 2020
p.000623: (A) VOLUNTARY SUBMISSIONS.—A responsible party for a clinical trial that is not an applicable clinical
p.000623: trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete
p.000623: clinical trial infor- mation described in paragraph (2) or paragraph (3) pro- vided the responsible party
p.000623: submits clinical trial informa- tion for each applicable clinical trial that is required to be submitted under
p.000623: section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act in
p.000623: an application or report for licensure, approval, or clearance of the drug or device for the use
p.000623: studied in the clinical trial.
p.000623: (B) REQUIRED SUBMISSIONS.—
p.000623: (i) IN GENERAL.—Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the
p.000623: Secretary determines for a specific clinical trial de- scribed in clause (ii) that posting in the registry and
p.000623: results data bank of clinical trial information for such clinical trial is necessary to protect the public health—
p.000623: (I) the Secretary may require by notification that such information be submitted to the Sec- retary in
p.000623: accordance with paragraphs (2) and (3) except with regard to timing of submission;
p.000623: (II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such in- formation
p.000623: shall be submitted not later than 30 days after the date specified by the Secretary in the notification;
p.000623: and
p.000623: (III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of
p.000623: the corresponding requirement of such paragraphs.
p.000623: (ii) CLINICAL TRIALS DESCRIBED.—A clinical trial described in this clause is—
p.000623: (I) an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and
p.000623: Cosmetic Act or licensed under section
p.000623: 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and
p.000623: Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on
p.000623: or after the date 10 years before the date of the enactment of the Food and Drug Ad- ministration
p.000623: Amendments Act of 2007; or
p.000623: (II) an applicable clinical trial that is de- scribed by both by paragraph (2)(C) and para- graph
p.000623: (3)(D)(ii)(II)).
p.000623: (C) UPDATES TO CLINICAL TRIAL DATA BANK.—
p.000623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000625: 625
p.000625: PUBLIC HEALTH SERVICE ACT
p.000625: Sec. 402
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p.000625: January 30, 2020
p.000625: (i) SUBMISSION OF UPDATES.—The responsible party for an applicable clinical trial shall submit to the
p.000625: Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the
p.000625: clinical trial information submitted under paragraph (2). Such updates—
p.000625: (I) shall be provided not less than once every
p.000625: 12 months, unless there were no changes to the clinical trial information during the preceding 12- month
p.000625: period;
p.000625: (II) shall include identification of the dates of any such changes;
p.000625: (III) not later than 30 days after the recruit- ment status of such clinical trial changes, shall in- clude an
p.000625: update of the recruitment status; and
p.000625: (IV) not later than 30 days after the comple- tion date of the clinical trial, shall include notifi-
p.000625: cation to the Director that such clinical trial is complete.
p.000625: (ii) PUBLIC AVAILABILITY OF UPDATES.—The Direc- tor of NIH shall make updates submitted under clause
p.000625: (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual
p.000625: site status, location, and contact information, the Di- rector of NIH shall ensure that updates to
p.000625: elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal
p.000625: of any informa- tion from the original submissions or any preceding updates, and information in such
p.000625: databases is pre- sented in a manner that enables users to readily ac- cess each original element submission
p.000625: and to track the changes made by the updates. The Director of NIH shall provide a link from the table of
p.000625: primary and sec- ondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this
p.000625: clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).
p.000625: (5) COORDINATION AND COMPLIANCE.—
p.000625: (A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED- ERAL AGENCIES.—
p.000625: (i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—If an applicable clinical trial is funded in whole or in part
p.000625: by a grant from any agency of the Department of Health and Human Services, including the Food and Drug
p.000625: Administration, the National Institutes of Health, or the Agency for Healthcare Research and
p.000625: Quality, any grant or progress report forms required under such grant shall include a certification that the
p.000625: responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).
p.000625: (ii) VERIFICATION BY FEDERAL AGENCIES.—The heads of the agencies referred to in clause (i), as appli- cable,
p.000625: shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the
p.000625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000625: Sec. 402 PUBLIC HEALTH SERVICE ACT 626
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p.000625: January 30, 2020
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p.000625: responsible party has been submitted under para- graphs (2) and (3) before releasing any
p.000625: remaining funding for a grant or funding for a future grant to such grantee.
p.000625: (iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the head of an agency referred to in clause (i), as applica- ble,
p.000625: verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agen- cy
p.000625: head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to cor- rect
p.000625: such non-compliance and submit the required clinical trial information.
p.000625: (iv) CONSULTATION WITH OTHER FEDERAL AGEN- CIES.—The Secretary shall—
p.000625: (I) consult with other agencies that conduct research involving human subjects in accordance with any
p.000625: section of part 46 of title 45, Code of Federal Regulations (or any successor regula- tions), to
p.000625: determine if any such research is an ap- plicable clinical trial; and
p.000625: (II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and
p.000625: (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under
p.000625: paragraphs (2) and (3).
p.000625: (B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUBMISSIONS.—At the time of sub-
p.000625: mission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, sec-
p.000625: tion 520(m) of such Act, or section 351 of this Act, or sub- mission of a report under section 510(k) of such
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p.000625: appropriate National Clinical Trial con- trol numbers.
p.000625: (C) QUALITY CONTROL.—
p.000625: (i) PILOT QUALITY CONTROL PROJECT.—Until the effective date of the regulations issued under para- graph
p.000625: (3)(D), the Secretary, acting through the Direc- tor of NIH and the Commissioner of Food and Drugs,
p.000625: shall conduct a pilot project to determine the optimal method of verification to help to ensure that
p.000625: the clin- ical trial information submitted under paragraph (3)(C) is non-promotional and is not
p.000625: false or mis- leading in any particular under subparagraph (D). The Secretary shall use the publicly available
p.000625: information described in paragraph (3)(A) and any other informa- tion available to the Secretary about
p.000625: applicable clinical trials to verify the accuracy of the clinical trial infor- mation submitted under
p.000625: paragraph (3)(C).
p.000625: (ii) NOTICE OF COMPLIANCE.—If the Secretary de- termines that any clinical trial information was not
p.000625: submitted as required under this subsection, or was
p.000625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000627: 627
p.000627: PUBLIC HEALTH SERVICE ACT
p.000627: Sec. 402
p.000627:
p.000627: submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and
p.000627: give such party an opportunity to remedy such non- compliance by submitting the required revised clinical trial
p.000627: information not later than 30 days after such no- tification.
p.000627: (D) TRUTHFUL CLINICAL TRIAL INFORMATION.—
p.000627: (i) IN GENERAL.—The clinical trial information submitted by a responsible party under this subsection shall
p.000627: not be false or misleading in any particular.
p.000627: (ii) EFFECT.—Clause (i) shall not have the effect
p.000627:
p.000627: of—
p.000627:
p.000627: (I) requiring clinical trial information with re- spect to an applicable clinical trial to include in-
p.000627: formation from any source other than such clinical trial involved; or
p.000627: (II) requiring clinical trial information de- scribed in paragraph (3)(D) to be submitted for purposes
p.000627: of paragraph (3)(C).
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p.000627: January 30, 2020
p.000627: (E) PUBLIC NOTICES.—
p.000627: (i) NOTICE OF VIOLATIONS.—If the responsible party for an applicable clinical trial fails to submit
p.000627: clinical trial information for such clinical trial as re- quired under paragraphs (2) or (3), the
p.000627: Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—
p.000627: (I) that the responsible party is not in compli- ance with this Act by—
p.000627: (aa) failing to submit required clinical trial information; or
p.000627: (bb) submitting false or misleading clin- ical trial information;
p.000627: (II) of the penalties imposed for the violation, if any; and
p.000627: (III) whether the responsible party has cor- rected the clinical trial information in the registry and results
p.000627: data bank.
p.000627: (ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND SECONDARY OUTCOMES.—If the responsible party for an
p.000627: applicable clinical trial fails to submit the primary and secondary outcomes as required under section
p.000627: 2(A)(ii)(I)(ll), the Director of NIH shall include in the registry and results data bank entry for such
p.000627: clinical trial a notice that the responsible party is not in com- pliance by failing to register the primary and
p.000627: sec- ondary outcomes in accordance with this act, and that the primary and secondary outcomes were not publicly
p.000627: disclosed in the database before conducting the clinical trial.
p.000627: (iii) FAILURE TO SUBMIT STATEMENT.—The notice under clause (i) for a violation described in clause
p.000627: (i)(I)(aa) shall include the following statement: ‘‘The entry for this clinical trial was not complete at
p.000627: the time of submission, as required by law. This may or
p.000627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000627: Sec. 402 PUBLIC HEALTH SERVICE ACT 628
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p.000627: may not have any bearing on the accuracy of the infor- mation in the entry.’’.
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p.000821: prescribe.
p.000821: (2) COMPENSATION.—The rate of compensation of the Exec- utive Director shall be fixed by the Board.
p.000821: (h) POWERS.—In carrying out subsection (b), the Foundation may—
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p.000821: January 30, 2020
p.000821: (1) operate under the direction of its Board;
p.000821: (2) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.000821: (3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties,
p.000821: and require surety bonds or make other provisions against losses occasioned by acts of such persons;
p.000821: (4) hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of
p.000821: the offi- cers and employees;
p.000821: (5) with the consent of any executive department or inde- pendent agency, use the information, services,
p.000821: staff, and facili- ties of such in carrying out this section;
p.000821: (6) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.000821: (7) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an
p.000821: interest under this part;
p.000821: (8) establish a process for the selection of candidates for positions under subsection (c);
p.000821: (9) enter into contracts with public and private organiza- tions for the writing, editing, printing, and
p.000821: publishing of books and other material;
p.000821: (10) take such action as may be necessary to obtain pat- ents and licenses for devices and procedures
p.000821: developed by the Foundation and its employees;
p.000821: (11) solicit, accept, hold, administer, invest, and spend any gift, devise, or bequest of real or personal property
p.000821: made to the Foundation;
p.000821: (12) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion;
p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
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p.000821: Sec. 499 PUBLIC HEALTH SERVICE ACT 822
p.000821:
p.000821: (13) appoint other groups of advisors as may be deter- mined necessary from time to time to carry out
p.000821: the functions of the Foundation;
p.000821: (14) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion; and
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p.000851: 851
p.000851: PUBLIC HEALTH SERVICE ACT
p.000851: Sec. 508
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p.000851: January 30, 2020
p.000851: (ii) the applicant will enter into an agreement with a public or nonprofit private entity under which
p.000851: the entity will provide the service, and the entity has entered into such a participation agreement plan
p.000851: and is qualified to receive such payments.
p.000851: (B) WAIVER OF PARTICIPATION AGREEMENTS.—
p.000851: (i) IN GENERAL.—In the case of an entity making an agreement pursuant to subparagraph (A)(ii) regard- ing the
p.000851: provision of services, the requirement estab- lished in such subparagraph regarding a participation agreement
p.000851: shall be waived by the Director if the entity does not, in providing health care services, impose a charge or
p.000851: accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or
p.000851: under any Federal or State health benefits plan.
p.000851: (ii) DONATIONS.—A determination by the Director of whether an entity referred to in clause (i) meets the criteria
p.000851: for a waiver under such clause shall be made without regard to whether the entity accepts voluntary donations
p.000851: regarding the provision of services to the public.
p.000851: (C) NONAPPLICATION OF CERTAIN REQUIREMENTS.— With respect to any authorized service that is
p.000851: available pursuant to the State plan described in subparagraph (A), the requirements established in such
p.000851: subparagraph shall not apply to the provision of any such service by an insti- tution for mental diseases to an
p.000851: individual who has at- tained 21 years of age and who has not attained 65 years of age. For purposes of the
p.000851: preceding sentence, the term ‘‘institution for mental diseases’’ has the meaning given such term in section
p.000851: 1905(i) of the Social Security Act.
p.000851: (f) REQUIREMENT OF MATCHING FUNDS.—
p.000851: (1) IN GENERAL.—With respect to the costs of the program to be carried out by an applicant pursuant to subsection (a),
p.000851: a funding agreement for an award under such subsection is that the applicant will make available (directly or
p.000851: through dona- tions from public or private entities) non-Federal contributions toward such costs in an amount that—
p.000851: (A) for the first fiscal year for which the applicant re- ceives payments under an award under such subsection, is not
p.000851: less than $1 for each $9 of Federal funds provided in the award;
...

p.000865: (2) ANNUAL REPORT ON STATE UNDERAGE DRINKING PRE- VENTION AND ENFORCEMENT ACTIVITIES.—
p.000865: (A) IN GENERAL.—The Secretary shall, with input and collaboration from other appropriate Federal agencies,
p.000865: States, Indian tribes, territories, and public health, con- sumer, and alcohol beverage industry groups,
p.000865: annually issue a report on each State’s performance in enacting, en- forcing, and creating laws, regulations, and
p.000865: programs to prevent or reduce underage drinking.
p.000865: (B) STATE PERFORMANCE MEASURES.—
p.000865: (i) IN GENERAL.—The Secretary shall develop, in consultation with the Committee, a set of measures to be used in
p.000865: preparing the report on best practices.
p.000865: (ii) CATEGORIES.—In developing these measures, the Secretary shall consider categories including, but not
p.000865: limited to:
p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: 867
p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
...

p.000881: (A) State and local agencies, including agencies re- sponsible for early intervention and prevention
p.000881: services under title XIX of the Social Security Act, the State Chil- dren’s Health Insurance Program
p.000881: under title XXI of the Social Security Act, and programs funded by grants under title V of the Social Security Act;
p.000881: (B) local and national organizations that serve youth at risk for suicide and their families;
p.000881: (C) relevant national medical and other health and education specialty organizations;
p.000881: (D) youth who are at risk for suicide, who have sur- vived suicide attempts, or who are currently receiving
p.000881: care from early intervention services;
p.000881: (E) families and friends of youth who are at risk for suicide, who have survived suicide attempts, who
p.000881: are cur- rently receiving care from early intervention and preven- tion services, or who have completed
p.000881: suicide;
p.000881: (F) qualified professionals who possess the specialized knowledge, skills, experience, and relevant
p.000881: attributes needed to serve youth at risk for suicide and their families; and
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p.000881: January 30, 2020
p.000881: (G) third-party payers, managed care organizations, and related commercial industries.
p.000881: (3) POLICY DEVELOPMENT.—In carrying out this section, the Secretary shall—
p.000881: (A) coordinate and collaborate on policy development at the Federal level with the relevant
p.000881: Department of
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: Sec. 520E PUBLIC HEALTH SERVICE ACT 882
p.000881:
p.000881: Health and Human Services agencies and suicide working groups; and
p.000881: (B) consult on policy development at the Federal level with the private sector, including consumer, medical,
p.000881: sui- cide prevention advocacy groups, and other health and education professional-based organizations, with
p.000881: respect to State-sponsored statewide or tribal youth suicide early intervention and prevention strategies.
p.000881: (f) RULE OF CONSTRUCTION; RELIGIOUS AND MORAL ACCOMMO- DATION.—Nothing in this section shall be construed to
p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
...

p.000929: (2) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000929: (A) Subject to subparagraph (B), the Secretary may make a grant under subsection (a) only if, in the
p.000929: case of any service under such subsection that is covered in the State plan approved under title XIX of the
p.000929: Social Security Act for the State involved—
p.000929: (i) the public entity involved will provide the serv- ice directly, and the entity has entered into a partici-
p.000929: pation agreement under the State plan and is quali- fied to receive payments under such plan; or
p.000929: (ii) the public entity will enter into an agreement with an organization under which the organization
p.000929: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000929: Sec. 561 PUBLIC HEALTH SERVICE ACT 930
p.000929:
p.000929: will provide the service, and the organization has en- tered into such a participation agreement and is quali-
p.000929: fied to receive such payments.
p.000929: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000929: services under subsection (a), the requirement established in such subparagraph regarding a participation
p.000929: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000929: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000929: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000929: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000929: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000929: garding the provision of services to the public.
p.000929: (3) CERTAIN CONSIDERATIONS.—In making grants under subsection (a), the Secretary shall—
p.000929: (A) equitably allocate such assistance among the prin- cipal geographic regions of the United States;
p.000929: (B) consider the extent to which the public entity in- volved has a need for the grant; and
p.000929: (C) in the case of any public entity that is a political subdivision of a State or that is an Indian
p.000929: tribe or tribal organization—
p.000929: (i) shall consider any comments regarding the ap- plication of the entity for such a grant that are re-
p.000929: ceived by the Secretary from the State in which the entity is located; and
p.000929: (ii) shall give special consideration to the entity if the State agrees to provide a portion of the non-Fed-
p.000929: eral contributions required in subsection (c) regarding such a grant.
p.000929: (c) MATCHING FUNDS.—
p.000929: (1) IN GENERAL.—A funding agreement for a grant under subsection (a) is that the public entity involved
p.000929: will, with re- spect to the costs to be incurred by the entity in carrying out the purpose described
p.000929: in such subsection, make available (di- rectly or through donations from public or private entities)
...

p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
p.000935: provided access to systems of care operated pursuant to the grant, the demographic
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: PUBLIC HEALTH SERVICE ACT
p.000937: Sec. 565
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p.000937: January 30, 2020
p.000937: characteristics of the children, the types and costs of services pro- vided pursuant to the grant, the
p.000937: availability and use of third-party reimbursements, estimates of the unmet need for such services in the
p.000937: jurisdiction of the entity, and the manner in which the grant has been expended toward the establishment of a
p.000937: jurisdiction-wide system of care for children with a serious emotional disturbance, and such other
p.000937: information as the Secretary may require with re- spect to the grant.
p.000937: (g) DESCRIPTION OF INTENDED USES OF GRANT.—The Secretary may make a grant under section 561(a) only if—
p.000937: (1) the public entity involved submits to the Secretary a description of the purposes for which the
p.000937: entity intends to ex- pend the grant;
p.000937: (2) the description identifies the populations, areas, and lo- calities in the jurisdiction of the entity with a need
p.000937: for services under this section; and
p.000937: (3) the description provides information relating to the services and activities to be provided, including
p.000937: a description of the manner in which the services and activities will be co- ordinated with any similar
p.000937: services or activities of public or nonprofit entities.
p.000937: (h) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under section 561(a) only if an
p.000937: application for the grant is submitted to the Secretary, the application contains the description of intended uses
p.000937: required in subsection (g), and the application is in such form, is made in such manner, and contains
p.000937: such agree- ments, assurances, and information as the Secretary determines to be necessary to carry out this section.
p.000937: SEC. 565. ø290ff–4¿ GENERAL PROVISIONS.
...

p.000989:
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p.000989: Sec. 709 PUBLIC HEALTH SERVICE ACT 990
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p.000989: January 30, 2020
p.000989:
p.000989: (ii) such institution shall be assessed a risk-based premium in an amount equal to 10 percent of the prin- cipal amount
p.000989: of the loan.
p.000989: (B) DEFAULT MANAGEMENT PLAN.—An institution of the type described in subparagraph (A) shall prepare
p.000989: and submit to the Secretary for approval a plan that meets the requirements of paragraph (2)(B).
p.000989: (4) INELIGIBILITY.—An individual shall not be eligible to obtain a loan under this subpart for attendance
p.000989: at an institu- tion that has a default rate in excess of 20 percent.
p.000989: (c) REDUCTION OF RISK-BASED PREMIUM.—Lenders shall reduce by 50 percent the risk-based premium to
p.000989: eligible borrowers if a credit worthy parent or other responsible party co-signs the loan note.
p.000989: (d) ADMINISTRATIVE WAIVERS.—
p.000989: (1) HEARING.—The Secretary shall afford an institution not less than one hearing, and may consider
p.000989: mitigating cir- cumstances, prior to making such institution ineligible for par- ticipation in the program under this
p.000989: subpart.
p.000989: (2) EXCEPTIONS.—In carrying out this section with respect to an institution, the Secretary may grant an
p.000989: institution a waiver of requirements of paragraphs (2) through (4) of sub- section (b) if the Secretary
p.000989: determines that the default rate for such institution is not an accurate indicator because the vol- ume of
p.000989: the loans under this subpart made by such institution has been insufficient.
p.000989: (3) TRANSITION FOR CERTAIN INSTITUTIONS.—During the 3- year period beginning on the effective date of the
p.000989: Health Pro- fessions Education Extension Amendments of 1992—
p.000989: (A) subsection (b)(4) shall not apply with respect to any eligible institution that is a Historically Black
p.000989: College or University; and
p.000989: (B) any such institution that has a default rate in ex- cess of 20 percent, and any eligible borrower seeking
p.000989: a loan for attendance at the institution, shall be subject to subsection (b)(3) to the same extent and in the
p.000989: same man- ner as eligible institutions and borrowers described in such subsection.
p.000989: (e) PAYOFF TO REDUCE RISK CATEGORY.—An institution may pay off the outstanding principal and interest
p.000989: owed by the bor- rowers of such institution who have defaulted on loans made under this subpart in order to reduce
...

p.001123: other private and public entities.
p.001123: (3) METHODOLOGY.—The Director shall, in developing the methods used under paragraph (1), consider—
p.001123: (A) safety, efficacy, and effectiveness;
p.001123: (B) legal, social, and ethical implications;
p.001123: (C) costs, benefits, and cost-effectiveness;
p.001123: (D) comparisons to alternate health care practices and technologies; and
p.001123: (E) requirements of Food and Drug Administration ap- proval to avoid duplication.
p.001123: (c) SPECIFIC ASSESSMENTS.—
p.001123: (1) IN GENERAL.—The Director shall conduct or support specific assessments of health care technologies and
p.001123: practices.
p.001123: (2) REQUESTS FOR ASSESSMENTS.—The Director is author- ized to conduct or support assessments, on a
p.001123: reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the
p.001123: Department of Veterans Affairs, the Office of Personnel Management, and other public or pri- vate entities.
p.001123: (3) GRANTS AND CONTRACTS.—In addition to conducting as- sessments, the Director may make grants to, or enter
p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001123:
p.001123:
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p.001161: a fiscal year beginning after June 30, 1975, may be made for less than 90 per centum of its costs
p.001161: (as determined under regulations of the Secretary) unless the grant is to be made for a program or
p.001161: project for which a grant was made (under the same section) for the fiscal year ending June 30, 1975,
p.001161: for less than 90 per centum of its costs (as so determined), in which case a grant under such section
p.001161: for that program or project for a fiscal year beginning after that date may be made for a percentage which
p.001161: shall not be less than the percentage of its costs for which the fiscal year 1975 grant was made.
p.001161: (b) Grants under this title shall be payable in such install- ments and subject to such conditions as
p.001161: the Secretary may deter- mine to be appropriate to assure that such grants will be effectively utilized for the
p.001161: purposes for which made.
p.001161: (c) A grant may be made or contract entered into under section 1001 or 1002 for a family planning service project or
p.001161: program only upon assurances satisfactory to the Secretary that—
p.001161: (1) priority will be given in such project or program to the furnishing of such services to persons from
p.001161: low-income fami- lies; and
p.001161: (2) no charge will be made in such project or program for services provided to any person from a
p.001161: low-income family ex- cept to the extent that payment will be made by a third party
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001161:
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p.001161: Sec. 1007 PUBLIC HEALTH SERVICE ACT 1162
p.001161:
p.001161: (including a government agency) which is authorized or is under legal obligation to pay such charge.
p.001161: For purposes of this subsection, the term ‘‘low-income family’’ shall be defined by the Secretary in accordance with
p.001161: such criteria as he may prescribe so as to insure that economic status shall not be a deterrent to
p.001161: participation in the programs assisted under this title. (d)(1) A grant may be made or a contract entered
p.001161: into under section 1001 or 1005 only upon assurances satisfactory to the Sec- retary that informational or
p.001161: educational materials developed or made available under the grant or contract will be suitable for the purposes of
p.001161: this title and for the population or community to which they are to be made available, taking into account the
p.001161: educational and cultural background of the individuals to whom such materials are addressed and the standards of such
p.001161: population or community
p.001161: with respect to such materials.
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p.001197: support, peer mentoring, and parent to parent programs.
p.001197: (D) To develop individual and family service coordina- tion or case management systems.
p.001197: (E) To support other needs identified by the advisory board under subsection (b) for the State or
p.001197: American In- dian consortium involved.
p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
p.001197: (D) develop best practices in areas such as family or consumer support, return to work, housing or
p.001197: supportive living personal assistance services, assistive technology and devices, behavioral health
p.001197: services, substance abuse services, and traumatic brain injury treatment and reha- bilitation;
p.001197: (E) tailor existing State or American Indian consor- tium systems to provide accommodations to the needs
p.001197: of individuals with traumatic brain injury (including systems administered by the State or American Indian
p.001197: consortium departments responsible for health, mental health, labor/ employment, education, intellectual
p.001197: disabilities or develop- mental disorders, transportation, and correctional sys- tems);
p.001197: (F) improve data sets coordinated across systems and other needs identified by a State or American
p.001197: Indian con- sortium plan supported by its advisory council; and
p.001197: (G) develop capacity within targeted communities.
p.001197: (f) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.001197: coordinated as appropriate
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001197:
p.001197:
p.001197:
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p.001231: proposes to become a health maintenance organization and which the Secretary determines will when it be-
p.001231: comes operational provide basic and supplemental health services to its members in the manner prescribed
p.001231: by section 1301(b) and will be organized and operated in the manner prescribed by section 1301(c).
p.001231: (d)(1) Any employer who knowingly does not comply with one or more of the requirements of paragraph (1)
p.001231: or (2) of subsection
p.001231: (b) shall be subject to a civil penalty of not more than $10,000. If such noncompliance continues, a civil
p.001231: penalty may be assessed and collected under this subsection for each thirty-day period such non- compliance continues.
p.001231: Such penalty may be assessed by the Sec- retary and collected in a civil action brought by the United
p.001231: States in a United States district court.
p.001231: (2) In any proceeding by the Secretary to assess a civil penalty under this subsection, no penalty shall be
p.001231: assessed until the em- ployer charged shall have been given notice and an opportunity to present its views on such
p.001231: charge. In determining the amount of the penalty, or the amount agreed upon in compromise, the Secretary shall
p.001231: consider the gravity of the noncompliance and the dem- onstrated good faith of the employer charged in
p.001231: attempting to achieve rapid compliance after notification by the Secretary of a noncompliance.
p.001231: (3) In any civil action brought to review the assessment of a civil penalty assessed under this subsection,
p.001231: the court shall, at the request of any party to such action, hold a trial de novo on the as- sessment of such civil
p.001231: penalty and in any civil action to collect such a civil penalty, the court shall, at the request of any party to such
p.001231: action, hold a trial de novo on the assessment of such civil penalty unless in a prior civil action to review the
p.001231: assessment of such pen- alty the court held a trial de novo on such assessment.
p.001231: (e) For purposes of this section, the term ‘‘employer’’ does not include (1) the Government of the
p.001231: United States, the government of the District of Columbia or any territory or possession of the United
p.001231: States, a State or any political subdivision thereof, or any agency or instrumentality (including the United
p.001231: States Postal Serv- ice and Postal Rate Commission) of any of the foregoing, except that such term includes
p.001231: nonappropriated fund instrumentalities of the Government of the United States; or (2) a church, convention or
p.001231: association of churches, or any organization operated, supervised or controlled by a church, convention or
p.001231: association of churches which organization (A) is an organization described in section 501(c)(3) of the
p.001231: Internal Revenue Code of 1986, and (B) does not discriminate (i) in the employment, compensation,
p.001231: promotion, or termination of employment of any personnel, or (ii) in the extension of staff or other privileges
p.001231: to any physician or other health per- sonnel, because such persons seek to obtain or obtained health
p.001231: care, or participate in providing health care, through a health maintenance organization.
p.001231: (f) If the Secretary, after reasonable notice and opportunity for a hearing to a State, finds that it or any of its
...

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p.001235: Sec. 1318 PUBLIC HEALTH SERVICE ACT 1236
p.001235:
p.001235: tenance organizations. The Secretary may provide such technical assistance through grants to public and
p.001235: nonprofit private entities and contracts with public and private entities.
p.001235: (c) The authority of the Secretary to enter into contracts under subsections (a) and (b) shall be effective for any
p.001235: fiscal year only to such extent or in such amounts as are provided in advance by ap- propriation Acts.
p.001235: FINANCIAL DISCLOSURE
p.001235: SEC. 1318. ø300e–17¿ (a) Each health maintenance organiza- tion shall, in accordance with regulations of
p.001235: the Secretary, report to the Secretary financial information which shall include the fol- lowing:
p.001235: (1) Such information as the Secretary may require dem- onstrating that the health maintenance organization has
p.001235: a fis- cally sound operation.
p.001235: (2) A copy of the report, if any, filed with the Centers for Medicare & Medicaid Services containing
p.001235: the information re- quired to be reported under section 1124 of the Social Security Act by disclosing entities
p.001235: and the information required to be supplied under section 1902(a)(38) of such Act.
p.001235: (3) A description of transactions, as specified by the Sec- retary, between the health maintenance
p.001235: organization and a party in interest. Such transactions shall include—
p.001235: (A) any sale or exchange, or leasing of any property between the health maintenance organization and a party
p.001235: in interest;
p.001235: (B) any furnishing for consideration of goods, services (including management services), or facilities
p.001235: between the health maintenance organization and a party in interest, but not including salaries paid to
p.001235: employees for services provided in the normal course of their employment and health services provided
p.001235: to members by hospitals and other providers and by staff, medical group (or groups), in- dividual practice
p.001235: association (or associations), or any com- bination thereof; and
p.001235: (C) any lending of money or other extension of credit between a health maintenance organization and a party in
p.001235: interest.
p.001235: The Secretary may require that information reported respecting a health maintenance organization which
p.001235: controls, is controlled by, or is under common control with, another entity be in the form of a
p.001235: consolidated financial statement for the organization and such entity.
p.001235: (b) For the purposes of this section the term ‘‘party in interest’’ means:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235: January 30, 2020
p.001235: (1) any director, officer, partner, or employee responsible for management or administration of a health
p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
p.001235: centum of the equity of the or- ganization, any person who is the beneficial owner of a mort- gage, deed of
p.001235: trust, note, or other interest secured by, and val- uing more than 5 per centum of the health maintenance orga-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001235:
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p.001235:
p.001235:
p.001237: 1237
p.001237: PUBLIC HEALTH SERVICE ACT
p.001237: Sec. 1318
p.001237:
p.001237: nization, and, in the case of a health maintenance organization organized as a nonprofit corporation, an
p.001237: incorporator or mem- ber of such corporation under applicable State corporation law;
p.001237: (2) any entity in which a person described in paragraph (1)—
p.001237: (A) is an officer or director;
p.001237: (B) is a partner (if such entity is organized as a part- nership);
p.001237: (C) has directly or indirectly a beneficial interest of more than 5 per centum of the equity; or
p.001237: (D) has a mortgage, deed of trust, note, or other inter- est valuing more than 5 per centum of the assets of
p.001237: such entity;
...

p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
p.001295: health services to adults with a serious mental illness and to children with a se- rious emotional disturbance;
p.001295: (2) the plan meets the criteria specified in subsection (b);
p.001295: and
p.001295: (3) the plan is approved by the Secretary.
p.001295:
p.001295:
p.001295:
p.001295:
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p.001295:
p.001295: January 30, 2020
p.001295: (b) CRITERIA FOR PLAN.—In accordance with subsection (a), a State shall submit to the Secretary a plan every
p.001295: two years that, at a minimum, includes each of the following:
p.001295: (1) SYSTEM OF CARE.—A description of the State’s system of care that contains the following:
p.001295: (A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYS- TEMS.—The plan shall—
p.001295: (i) identify the single State agency to be respon- sible for the administration of the program under
p.001295: the grant, including any third party who administers men- tal health services and is responsible for complying
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001295:
p.001295:
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p.001295:
p.001297: 1297
p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
p.001297:
p.001297:
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p.001297: January 30, 2020
p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
...

p.001321: (other than any such agreement that is not applicable to the State);
p.001321: (3) the agreements are made through certification from the chief executive officer of the State;
p.001321: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001321: Secretary;
p.001321: (5) the application contains the report required in section 1942(a);
p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
p.001321:
p.001321:
p.001321:
p.001321:
p.001321:
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p.001337:
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p.001337:
p.001337: January 30, 2020
p.001337: religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in
p.001337: a religious practice.
p.001337: (g) FISCAL ACCOUNTABILITY.—
p.001337: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization providing services under any
p.001337: substance abuse program under this title or title V shall be subject to the same regulations as other
p.001337: nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such
p.001337: funds provided under such program.
p.001337: (2) LIMITED AUDIT.—Such organization shall segregate gov- ernment funds provided under such substance abuse
p.001337: program into a separate account. Only the government funds shall be subject to audit by the government.
p.001337: (h) COMPLIANCE.—Any party that seeks to enforce such party’s rights under this section may assert a civil action for
p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
p.001337: religious organiza- tion to provide services under any substance abuse program under this title or title V shall be
p.001337: expended for sectarian worship, instruc- tion, or proselytization.
p.001337: (j) EFFECT ON STATE AND LOCAL FUNDS.—If a State or local government contributes State or local funds to
p.001337: carry out any sub- stance abuse program under this title or title V, the State or local government may segregate
p.001337: the State or local funds from the Fed- eral funds provided to carry out the program or may commingle the State
p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
...

p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
p.001347: geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for
p.001347: pregnant adolescents and adolescent parents in such area.
p.001347: (2) In making grants for demonstration projects for services under this title, the Secretary shall
p.001347: consider the special needs of
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001347:
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p.001359: under section 2112(d)(1).
p.001359: (2)(A) No person may bring a civil action for damages in an amount greater than $1,000 or in an
p.001359: unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising
p.001359: from a vaccine-related injury or death associated with the administration of a vaccine after the effective
p.001359: date of this part, and no such court may award damages in an amount greater than $1,000 in a civil action for
p.001359: damages for such a vaccine-related injury or death,
p.001359: unless a petition has been filed, in accordance with section 2116, for compensation under the Program
p.001359: for such injury or death and—
p.001359: (i)(I) the United States Claims Court has issued a judgment under section 2112 on such petition, and
p.001359: (II) such person elects under section 2121(a) to file such an action, or
p.001359: (ii) such person elects to withdraw such petition under section 2121(b) or such petition is considered withdrawn
p.001359: under such section.
p.001359: (B) If a civil action which is barred under subparagraph
p.001359: (A) is filed in a State or Federal court, the court shall dismiss the action. If a petition is filed under this section
p.001359: with respect to the injury or death for which such civil action was brought, the date such dismissed action was filed
p.001359: shall, for purposes of the limitations of actions prescribed by section 2116, be consid- ered the date the petition
p.001359: was filed if the petition was filed within one year of the date of the dismissal of the civil action.
p.001359: (3) No vaccine administrator or manufacturer may be made a party to a civil action (other than a
p.001359: civil action which may be brought under paragraph (2)) for damages for a vac- cine-related injury or death
p.001359: associated with the administration of a vaccine after the effective date of this part. 2
p.001359: (4) If in a civil action brought against a vaccine adminis- trator or manufacturer before the effective
p.001359: date of this part 2 damages were denied for a vaccine-related injury or death or if such civil action
p.001359: was dismissed with prejudice, the person who brought such action may file a petition under subsection
p.001359: (b) for such injury or death.
p.001359: (5)(A) A plaintiff who on the effective date of this part 2
p.001359: has pending a civil action for damages for a vaccine-related in-
p.001359:
p.001359:
p.001359:
p.001359: January 30, 2020
p.001359: 2 Effective October 1, 1988.
p.001359:
p.001359: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001359:
p.001359:
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p.001359: Sec. 2111 PUBLIC HEALTH SERVICE ACT 1360
p.001359:
p.001359: jury or death may, at any time within 2 years after the effec- tive date of this part 2 or before
p.001359: judgment, whichever occurs first, petition to have such action dismissed without prejudice or costs and file
p.001359: a petition under subsection (b) for such injury or death.
p.001359: (B) If a plaintiff has pending a civil action for damages for a vaccine-related injury or death, such person may
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p.001365: 1365
p.001365: PUBLIC HEALTH SERVICE ACT
p.001365: Sec. 2112
p.001365:
p.001365: (i) include findings of fact and conclusions of law, and
p.001365: (ii) be issued as expeditiously as practicable but not later than 240 days, exclusive of suspended time
p.001365: under subparagraph (C), after the date the petition was filed.
p.001365: The decision of the special master may be reviewed by the United States Claims Court in accordance with
p.001365: subsection (e).
p.001365: (B) In conducting a proceeding on a petition a special mas- ter—
p.001365: (i) may require such evidence as may be reasonable and necessary,
p.001365: (ii) may require the submission of such information as may be reasonable and necessary,
p.001365: (iii) may require the testimony of any person and the production of any documents as may be reasonable
p.001365: and necessary,
p.001365: (iv) shall afford all interested persons an opportunity to submit relevant written information—
p.001365: (I) relating to the existence of the evidence de- scribed in section 2113(a)(1)(B), or
p.001365: (II) relating to any allegation in a petition with re- spect to the matters described in
p.001365: section 2111(c)(1)(C)(ii), and
p.001365: (v) may conduct such hearings as may be reasonable and necessary.
p.001365: There may be no discovery in a proceeding on a petition other than the discovery required by the special master.
p.001365: (C) In conducting a proceeding on a petition a special mas- ter shall suspend the proceedings one time for 30
p.001365: days on the motion of either party. After a motion for suspension is grant- ed, further motions for suspension
p.001365: by either party may be granted by the special master, if the special master determines the suspension is
p.001365: reasonable and necessary, for an aggregate period not to exceed 150 days.
p.001365: (D) If, in reviewing proceedings on petitions for vaccine-re- lated injuries or deaths associated with the
p.001365: administration of vaccines before the effective date of this part, the chief special master determines that the
p.001365: number of filings and resultant workload place an undue burden on the parties or the special master
p.001365: involved in such proceedings, the chief special master may, in the interest of justice, suspend proceedings on
p.001365: any pe- tition for up to 30 months (but for not more than 6 months at a time) in addition to the suspension time under
p.001365: subparagraph (C).
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365: January 30, 2020
p.001365: (4)(A) Except as provided in subparagraph (B), information submitted to a special master or the court in a
p.001365: proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the
p.001365: express written consent of the person who submitted the information.
p.001365: (B) A decision of a special master or the court in a pro- ceeding shall be disclosed, except that if
p.001365: the decision is to in- clude information—
p.001365: (i) which is trade secret or commercial or financial in- formation which is privileged and confidential, or
p.001365: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
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p.001365:
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p.001365:
p.001365: Sec. 2112 PUBLIC HEALTH SERVICE ACT 1366
p.001365:
p.001365: (ii) which are medical files and similar files the disclo- sure of which would constitute a clearly unwarranted inva-
p.001365: sion of privacy,
p.001365: and if the person who submitted such information objects to the inclusion of such information in the
p.001365: decision, the decision shall be disclosed without such information.
p.001365: (e) ACTION BY THE UNITED STATES CLAIMS COURT.—
p.001365: (1) Upon issuance of the special master’s decision, the par- ties shall have 30 days to file with the clerk
p.001365: of the United States Claims Court a motion to have the court review the de- cision. If such a motion is filed, the
p.001365: other party shall file a re- sponse with the clerk of the United States Claims Court no later than 30 days
p.001365: after the filing of such motion.
p.001365: (2) Upon the filing of a motion under paragraph (1) with respect to a petition, the United States
p.001365: Claims Court shall have jurisdiction to undertake a review of the record of the proceedings and may
p.001365: thereafter—
p.001365: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s
p.001365: deci- sion,
p.001365: (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary,
p.001365: capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings
p.001365: of fact and conclusions of law, or
p.001365: (C) remand the petition to the special master for fur- ther action in accordance with the court’s direction.
p.001365: The court shall complete its action on a petition within 120 days of the filing of a response under
p.001365: paragraph (1) excluding any days the petition is before a special master as a result of a remand under
p.001365: subparagraph (C). The court may allow not more than 90 days for remands under subparagraph (C).
p.001365: (3) In the absence of a motion under paragraph (1) respect- ing the special master’s decision or if the United States
p.001365: Claims Court takes the action described in paragraph (2)(A) with re- spect to the special master’s
p.001365: decision, the clerk of the United States Claims Court shall immediately enter judgment in ac- cordance
p.001365: with the special master’s decision.
...

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p.001379:
p.001379:
p.001381: 1381
p.001381: PUBLIC HEALTH SERVICE ACT
p.001381: Sec. 2123
p.001381:
p.001381: erly prepared and was accompanied by proper directions and warnings.
p.001381: (2) For purposes of paragraph (1), a vaccine shall be pre- sumed to be accompanied by proper directions and
p.001381: warnings if the vaccine manufacturer shows that it complied in all mate- rial respects with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service
p.001381: Act (including regulations issued under such provi- sions) applicable to the vaccine and related to
p.001381: vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
p.001381: (A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section
p.001381: 2123(d)(2), or
p.001381: (B) by clear and convincing evidence that the manufac- turer failed to exercise due care notwithstanding its
p.001381: com- pliance with such Act and section (and regulations issued under such provisions).
p.001381: (c) DIRECT WARNINGS.—No vaccine manufacturer shall be lia- ble in a civil action for damages arising
p.001381: from a vaccine-related in- jury or death associated with the administration of a vaccine after the effective date
p.001381: of this part 24 solely due to the manufacturer’s failure to provide direct warnings to the injured
p.001381: party (or the in- jured party’s legal representative) of the potential dangers result- ing from the
p.001381: administration of the vaccine manufactured by the manufacturer.
p.001381: (d) CONSTRUCTION.—The standards of responsibility prescribed by this section are not to be construed as authorizing a
p.001381: person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in
p.001381: which damages were denied or which was dismissed with prejudice to bring a new civil action against such
p.001381: manufacturer for such injury or death.
p.001381: (e) PREEMPTION.—No State may establish or enforce a law which prohibits an individual from bringing a
p.001381: civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is
p.001381: not barred by this subtitle.
p.001381: TRIAL
p.001381: SEC. 2123. ø300aa–23¿ (a) GENERAL RULE.—A civil action against a vaccine manufacturer for damages
p.001381: for a vaccine-related injury or death associated with the administration of a vaccine after the effective
p.001381: date of this part 24 which is not barred by section 2111(a)(2) shall be tried in three stages.
p.001381: (b) LIABILITY.—The first stage of such a civil action shall be held to determine if a vaccine manufacturer is
p.001381: liable under section 2122.
p.001381: (c) GENERAL DAMAGES.—The second stage of such a civil action shall be held to determine the amount of damages (other
p.001381: than pu- nitive damages) a vaccine manufacturer found to be liable under section 2122 shall be required to
p.001381: pay.
p.001381: (d) PUNITIVE DAMAGES.—
p.001381: (1) If sought by the plaintiff, the third stage of such an ac- tion shall be held to determine the amount of
p.001381: punitive dam-
p.001381:
p.001381:
p.001381:
p.001381: January 30, 2020
...

p.001461: which the entity will provide the service, and the entity has en- tered into such a participation
p.001461: agreement and is qualified to receive such payments.
p.001461: (2) WAIVER.—
p.001461: (A) IN GENERAL.—In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the pro-
p.001461: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001461:
p.001461:
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p.001461:
p.001461: Sec. 2604 PUBLIC HEALTH SERVICE ACT 1462
p.001461:
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p.001461:
p.001461: January 30, 2020
p.001461:
p.001461: vision of services, the requirement established in such paragraph shall be waived by the HIV health
p.001461: services planning council for the eligible area if the entity does not, in providing health care services, impose
p.001461: a charge or ac- cept reimbursement available from any third-party payor, including reimbursement under any
p.001461: insurance policy or under any Federal or State health benefits program.
p.001461: (B) DETERMINATION.—A determination by the HIV health services planning council of whether an entity
p.001461: re- ferred to in subparagraph (A) meets the criteria for a waiv- er under such subparagraph shall be made without
p.001461: regard to whether the entity accepts voluntary donations for the purpose of providing services to the public.
p.001461: (h) ADMINISTRATION.—
p.001461: (1) LIMITATION.—The chief elected official of an eligible area shall not use in excess of 10 percent of amounts
p.001461: received under a grant under this subpart for administrative expenses.
p.001461: (2) ALLOCATIONS BY CHIEF ELECTED OFFICIAL.—In the case of entities and subcontractors to which the chief elected
p.001461: official of an eligible area allocates amounts received by the official under a grant under this subpart, the
p.001461: official shall ensure that, of the aggregate amount so allocated, the total of the expendi- tures by such entities for
p.001461: administrative expenses does not ex- ceed 10 percent (without regard to whether particular entities expend more
p.001461: than 10 percent for such expenses).
p.001461: (3) ADMINISTRATIVE ACTIVITIES.—For purposes of para- graph (1), amounts may be used for
p.001461: administrative activities that include—
p.001461: (A) routine grant administration and monitoring ac- tivities, including the development of applications for part
p.001461: A funds, the receipt and disbursal of program funds, the development and establishment of reimbursement
p.001461: and ac- counting systems, the development of a clinical quality management program as described in
...

p.001465: (9) that the eligible area has procedures in place to ensure that services provided with funds received under
p.001465: this subpart meet the criteria specified in section 2604(b)(1); and
p.001465: (10) that the chief elected official will submit to the lead State agency under section 2617(b)(4),
p.001465: audits, consistent with Office of Management and Budget circular A133, regarding funds expended in
p.001465: accordance with this subpart every 2 years and shall include necessary client-based data to compile unmet need
p.001465: calculations and Statewide coordinated statements of need process.
p.001465: (b) APPLICATION.—An eligible area that desires to receive a grant under section 2603(b) shall prepare and
p.001465: submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001465: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001465: shall require, in- cluding the information required under such subsection and infor- mation concerning—
p.001465: (1) the number of individuals to be served within the eligi- ble area with assistance provided under the grant,
p.001465: including the identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of section
p.001465: 2603(b)(2)(A);
p.001465: (2) demographic data on the population of such individ- uals;
p.001465: (3) the average cost of providing each category of HIV-re- lated health services and the extent to which such
p.001465: cost is paid by third-party payors;
p.001465: (4) the aggregate amounts expended for each such category of services;
p.001465: (5) the manner in which the expected expenditures are re- lated to the planning process for States that receive
p.001465: funding under part B (including the planning process described in sec- tion 2617(b)); and
p.001465: (6) the expected expenditures and how those expenditures will improve overall client outcomes, as
p.001465: described under the State plan under section 2617(b), and through additional out- comes measures as
p.001465: identified by the HIV health services plan- ning council under section 2602(b).
p.001465: (c) SINGLE APPLICATION AND GRANT AWARD.—
p.001465: (1) APPLICATION.—The Secretary may phase in the use of a single application that meets the requirements of
p.001465: subsections
p.001465: (a) and (b) of section 2603 with respect to an eligible area that desires to receive grants under section 2603
p.001465: for a fiscal year.
p.001465: (2) GRANT AWARD.—The Secretary may phase in the awarding of a single grant to an eligible area that
p.001465: submits an approved application under paragraph (1) for a fiscal year.
p.001465: (d) DATE CERTAIN FOR SUBMISSION.—
p.001465: (1) REQUIREMENT.—Except as provided in paragraph (2), to be eligible to receive a grant under section 2601(a) for a
p.001465: fiscal year, an application under subsection (a) shall be submitted
p.001465: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001465:
p.001465:
p.001465:
p.001465:
p.001465:
p.001465:
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p.001479:
p.001479:
p.001481: 1481
p.001481: PUBLIC HEALTH SERVICE ACT
p.001481: Sec. 2617
p.001481:
p.001481:
p.001481:
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p.001481:
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p.001481:
p.001481:
p.001481: January 30, 2020
p.001481: quested, and the number of individuals and families receiving such services, that shall include—
p.001481: (A) a description of the types of programs operated or funded by the State for the provision of HIV-related
p.001481: serv- ices during the year preceding the year for which the grant is requested and the methods utilized by the
p.001481: State to fi- nance such programs;
p.001481: (B) an accounting of the amount of funds that the State has expended for such services and programs during the
p.001481: year preceding the year for which the grant is re- quested; and
p.001481: (C) information concerning—
p.001481: (i) the number of individuals to be served with as- sistance provided under the grant;
p.001481: (ii) demographic data on the population of the in- dividuals to be served;
p.001481: (iii) the average cost of providing each category of HIV-related health services and the extent to which such
p.001481: cost is paid by third-party payors; and
p.001481: (iv) the aggregate amounts expended for each such category of services;
p.001481: (2) a determination of the size and demographics of the population of individuals with HIV/AIDS in the State;
p.001481: (3) a determination of the needs of such population, with particular attention to—
p.001481: (A) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services; and
p.001481: (B) disparities in access and services among affected subpopulations and historically underserved
p.001481: communities;
p.001481: (4) the designation of a lead State agency that shall—
p.001481: (A) administer all assistance received under section 2611;
p.001481: (B) conduct the needs assessment and prepare the State plan under paragraph (3);
p.001481: (C) prepare all applications for assistance under sec- tion 2611;
p.001481: (D) receive notices with respect to programs under this title;
p.001481: (E) every 2 years, collect and submit to the Secretary all audits, consistent with Office of
p.001481: Management and Budget circular A133, from grantees within the State, in- cluding audits regarding funds
p.001481: expended in accordance with section 2611; and
p.001481: (F) carry out any other duties determined appropriate by the Secretary to facilitate the coordination of programs under
p.001481: this title.
p.001481: (5) a comprehensive plan that describes the organization and delivery of HIV health care and support
...

p.001485: and (E) of paragraph (1) re- garding the imposition of charges for services applies to the an- nual aggregate of
p.001485: charges imposed for such services, without regard to whether they are characterized as enrollment fees,
p.001485: premiums, deductibles, cost sharing, copayments, coinsurance, or other charges.
p.001485: (4) WAIVER.—
p.001485: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001485:
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p.001485: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1486
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p.001485: January 30, 2020
p.001485:
p.001485: (A) IN GENERAL.—The State shall waive the require- ments established in paragraphs (1) through (3) in
p.001485: the case of an entity that does not, in providing health care services, impose a charge or accept
p.001485: reimbursement from any third-party payor, including reimbursement under any insurance policy or under any Federal or
p.001485: State health ben- efits program.
p.001485: (B) DETERMINATION.—A determination by the State of whether an entity referred to in subparagraph (A) meets the
p.001485: criteria for a waiver under such subparagraph shall be made without regard to whether the entity accepts vol-
p.001485: untary donations regarding the provision of services to the public.
p.001485: (d) REQUIREMENT OF MATCHING FUNDS REGARDING STATE AL-
p.001485: LOTMENTS.—
p.001485: (1) IN GENERAL.—In the case of any State to which the cri- terion described in paragraph (3) applies, the
p.001485: Secretary may not make a grant under section 2611 unless the State agrees that, with respect to the
p.001485: costs to be incurred by the State in carrying out the program for which the grant was awarded, the State will,
p.001485: subject to subsection (b)(2), make available (directly or through donations from public or private entities)
p.001485: non-Fed- eral contributions toward such costs in an amount equal to—
p.001485: (A) for the first fiscal year of payments under the grant, not less than 162⁄3 percent of such costs ($1 for
p.001485: each
p.001485: $5 of Federal funds provided in the grant);
p.001485: (B) for any second fiscal year of such payments, not less than 20 percent of such costs ($1 for each
p.001485: $4 of Fed- eral funds provided in the grant);
p.001485: (C) for any third fiscal year of such payments, not less than 25 percent of such costs ($1 for each $3 of
p.001485: Federal funds provided in the grant);
p.001485: (D) for any fourth fiscal year of such payments, not less than 331⁄3 percent of such costs ($1 for each $2 of
p.001485: Fed- eral funds provided in the grant); and
...

p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
p.001509: accept reimbursement avail- able from any third-party payor, including reimbursement under any insurance
p.001509: policy or under any Federal or State health benefits program.
p.001509:
p.001509:
p.001509:
p.001509: January 30, 2020
p.001509: 13 See footnote for section 217(a).
p.001509:
p.001509: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001509:
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p.001509: Sec. 2653 PUBLIC HEALTH SERVICE ACT 1510
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p.001509: January 30, 2020
p.001509:
p.001509: (B) A determination by the Secretary of whether an entity referred to in subparagraph (A) meets the
p.001509: criteria for a waiver under such subparagraph shall be made with- out regard to whether the entity accepts
p.001509: voluntary dona- tions regarding the provision of services to the public.
p.001509: SEC. 2653. ø300ff–53¿ PREFERENCES IN MAKING GRANTS.
p.001509: (a) IN GENERAL.—In making grants under section 2651, the Secretary shall give preference to any qualified
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p.001513:
p.001513:
p.001513:
p.001513: January 30, 2020
p.001513:
p.001513: appropriated through this Act will be carried out in accordance with conditions described in sections 2661 and
p.001513: 2662.
p.001513: SEC. 2664. ø300ff–64¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001513: (a) REPORTS TO SECRETARY.—The Secretary may not make a grant under this part unless—
p.001513: (1) the applicant submits to the Secretary—
p.001513: (A) a specification of the expenditures made by the ap- plicant for early intervention services for the fiscal
p.001513: year preceding the fiscal year for which the applicant is apply- ing to receive the grant;
p.001513: (B) an estimate of the number of individuals to whom the applicant has provided such services for such fiscal
p.001513: year;
p.001513: (C) information regarding how the expected expendi- tures of the grant are related to the planning
p.001513: process for localities funded under part A (including the planning process described in section 2602) and
p.001513: for States funded under part B (including the planning process described in section 2617(b)); and
p.001513: (D) a specification of the expected expenditures and how those expenditures will improve overall client
p.001513: out- comes, as described in the State plan under section 2617(b);
p.001513: (2) the applicant agrees to submit to the Secretary a report providing—
p.001513: (A) the number of individuals to whom the applicant provides early intervention services pursuant to the grant;
p.001513: (B) epidemiological and demographic data on the pop- ulation of such individuals;
p.001513: (C) the extent to which the costs of HIV-related health care for such individuals are paid by third-party payors;
p.001513: (D) the average costs of providing each category of early intervention service; and
p.001513: (E) the aggregate amounts expended for each such cat- egory;
p.001513: (3) the applicant agrees to provide additional documenta- tion to the Secretary regarding the process used to
p.001513: obtain com- munity input into the design and implementation of activities related to such grant; and
p.001513: (4) the applicant agrees to submit, every 2 years, to the lead State agency under section 2617(b)(4)
p.001513: audits, consistent with Office of Management and Budget circular A133, regard- ing funds expended in
p.001513: accordance with this title and shall in- clude necessary client level data to complete unmet need cal-
p.001513: culations and Statewide coordinated statements of need proc- ess.
p.001513: (b) PROVISION OF OPPORTUNITIES FOR ANONYMOUS COUNSELING AND TESTING.—The Secretary may not make a grant
p.001513: under this part unless the applicant for the grant agrees that, to the extent permitted under State law,
p.001513: regulation or rule, the applicant will offer substantial opportunities for an individual—
p.001513: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001513:
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p.001515: 1515
p.001515: PUBLIC HEALTH SERVICE ACT
p.001515: Sec. 2664
p.001515:
p.001515: (1) to undergo counseling and testing regarding HIV/AIDS without being required to provide any information
p.001515: relating to the identity of the individual; and
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p.001669: shall be ap- pointed only for the remainder of that term. A member may serve after the expiration of that
p.001669: member’s term until a successor has been appointed. A vacancy in the HIT Ad- visory Committee shall be filled in
p.001669: the manner in which the original appointment was made.
p.001669: (C) LIMITS.—Members of the HIT Advisory Committee shall be limited to two 3-year terms, for a total of not
p.001669: to exceed 6 years of service on the Committee.
p.001669: (5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee shall ensure an opportunity for the participation in
p.001669: activities of the Committee of outside advisors, including individuals with expertise in the development of
p.001669: policies and standards for the electronic exchange and use of health information, includ- ing in the areas of
p.001669: health information privacy and security.
p.001669: (6) QUORUM.—A majority of the members of the HIT Advi- sory Committee shall constitute a quorum for purposes of vot-
p.001669: ing, but a lesser number of members may meet and hold hear- ings.
p.001669: (7) CONSIDERATION.—The National Coordinator shall en- sure that the relevant and available recommendations
p.001669: and comments from the National Committee on Vital and Health Statistics are considered in the development of
p.001669: policies.
p.001669: (8) ASSISTANCE.—For the purposes of carrying out this sec- tion, the Secretary may provide or ensure that financial
p.001669: assist- ance is provided by the HIT Advisory Committee to defray in whole or in part any membership fees or
p.001669: dues charged by such Committee to those consumer advocacy groups and not-for- profit entities that work in
p.001669: the public interest as a party of their mission.
p.001669: (e) APPLICATION OF FACA.—The Federal Advisory Committee Act (5 U.S.C. App.), other than section 14 of
p.001669: such Act, shall apply to the HIT Advisory Committee.
p.001669: (f) PUBLICATION.—The Secretary shall provide for publication in the Federal Register and the posting on the
p.001669: Internet website of the Office of the National Coordinator for Health Information Tech- nology of all policy
p.001669: recommendations made by the HIT Advisory Committee under this section.
p.001669: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001669:
p.001669:
p.001669:
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p.001669:
p.001669: Sec. 3003 PUBLIC HEALTH SERVICE ACT 1670
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p.001669: January 30, 2020
p.001669:
p.001669: SEC. 3003. ø300jj–13¿ SETTING PRIORITIES FOR STANDARDS ADOP- TION.
p.001669: (a) IDENTIFYING PRIORITIES.—
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p.001675:
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p.001675: January 30, 2020
p.001675: (d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.— The National Coordinator and the Office for Civil Rights
p.001675: of the De- partment of Health and Human Services shall jointly promote pa- tient access to health
p.001675: information in a manner that would ensure that such information is available in a form convenient for the pa-
p.001675: tient, in a reasonable manner, without burdening the health care provider involved.
p.001675: (e) ACCESSIBILITY OF PATIENT RECORDS.—
p.001675: (1) ACCESSIBILITY AND UPDATING OF INFORMATION.—
p.001675: (A) IN GENERAL.—The Secretary, in consultation with the National Coordinator, shall promote policies that
p.001675: en- sure that a patient’s electronic health information is acces- sible to that patient and the patient’s designees, in
p.001675: a man- ner that facilitates communication with the patient’s health care providers and other
p.001675: individuals, including re- searchers, consistent with such patient’s consent.
p.001675: (B) UPDATING EDUCATION ON ACCESSING AND EX- CHANGING PERSONAL HEALTH INFORMATION.—To promote
p.001675: awareness that an individual has a right of access to in- spect, obtain a copy of, and transmit to a
p.001675: third party a copy of such individual’s protected health information pur- suant to the Health Information
p.001675: Portability and Account- ability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations),
p.001675: the Director of the Office for Civil Rights, in consultation with the National Coordi- nator, shall assist
p.001675: individuals and health care providers in understanding a patient’s rights to access and protect per- sonal health
p.001675: information under the Health Insurance Port- ability and Accountability Act of 1996 (Public Law 104– 191),
p.001675: including providing best practices for requesting per- sonal health information in a computable format, including using
p.001675: patient portals or third-party applications and com- mon cases when a provider is permitted to exchange
p.001675: and provide access to health information.
p.001675: (2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the
p.001675: National Coordinator may require that—
p.001675: (A) the certification criteria support—
p.001675: (i) patient access to their electronic health infor- mation, including in a single longitudinal format
p.001675: that is easy to understand, secure, and may be updated automatically;
p.001675: (ii) the patient’s ability to electronically commu- nicate patient-reported information (such as family
p.001675: history and medical history); and
p.001675: (iii) patient access to their personal electronic health information for research at the option of the pa-
p.001675: tient; and
p.001675: (B) the HIT Advisory Committee develop and prioritize standards, implementation specifications,
p.001675: and certification criteria required to help support patient ac- cess to electronic health information, patient
p.001675: usability, and support for technologies that offer patients access to their electronic health information in
p.001675: a single, longitudinal for-
p.001675: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001675:
p.001675:
p.001675:
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p.001719:
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p.001719: January 30, 2020
p.001719:
p.001719: (C) FINAL REGULATIONS.—Based on all the available evidence in the rulemaking record, the WTC Program Ad-
p.001719: ministrator shall make a final determination of whether cancer or a certain type of cancer should be added to
p.001719: such list of WTC-related health conditions. If such a determina- tion is made to make such an addition, the WTC Program
p.001719: Administrator shall by regulation add cancer or the certain type of cancer to such list.
p.001719: (D) DETERMINATIONS NOT TO ADD CANCER OR CERTAIN TYPES OF CANCER.—In the case that the WTC Program Ad-
p.001719: ministrator determines under subparagraph (B) or (C) that cancer or a certain type of cancer should not be
p.001719: added to such list of WTC-related health conditions, the WTC Pro- gram Administrator shall publish an
p.001719: explanation for such determination in the Federal Register. Any such deter- mination to not make such an
p.001719: addition shall not preclude the addition of cancer or the certain type of cancer to such list at a later date.
p.001719: (6) ADDITION OF HEALTH CONDITIONS TO LIST FOR WTC RE- SPONDERS.—
p.001719: (A) IN GENERAL.—Whenever the WTC Program Ad- ministrator determines that a proposed rule should be pro- mulgated
p.001719: to add a health condition to the list of health conditions in paragraph (3), the Administrator may re-
p.001719: quest a recommendation of the Advisory Committee or may publish such a proposed rule in the Federal
p.001719: Register in accordance with subparagraph (D).
p.001719: (B) ADMINISTRATOR’S OPTIONS AFTER RECEIPT OF PETI- TION.—In the case that the WTC Program Administrator
p.001719: receives a written petition by an interested party to add a health condition to the list of health conditions
p.001719: in para- graph (3), not later than 90 days after the date of receipt of such petition the Administrator
p.001719: shall—
p.001719: (i) request a recommendation of the Advisory Committee;
p.001719: (ii) publish a proposed rule in the Federal Register to add such health condition, in accordance with sub-
p.001719: paragraph (D);
p.001719: (iii) publish in the Federal Register the Adminis- trator’s determination not to publish such a proposed
p.001719: rule and the basis for such determination; or
p.001719: (iv) publish in the Federal Register a determina- tion that insufficient evidence exists to take action
p.001719: under clauses (i) through (iii).
p.001719: (C) ACTION BY ADVISORY COMMITTEE.—In the case that the Administrator requests a recommendation of the Advi- sory
p.001719: Committee under this paragraph, with respect to add- ing a health condition to the list in paragraph (3), the Ad-
p.001719: visory Committee shall submit to the Administrator such recommendation not later than 90 days after the
p.001719: date of such request or by such date (not to exceed 180 days after such date of request) as specified by the
p.001719: Administrator. Not later than 90 days after the date of receipt of such rec- ommendation, the Administrator shall, in
p.001719: accordance with
p.001719: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001719:
p.001719:
p.001719:
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p.001719:
p.001719:
p.001721: 1721
p.001721: PUBLIC HEALTH SERVICE ACT
p.001721: Sec. 3312
p.001721:
p.001721: subparagraph (D), publish in the Federal Register a pro- posed rule with respect to such recommendation
p.001721: or a de- termination not to propose such a proposed rule and the basis for such determination.
p.001721: (D) PUBLICATION.—The WTC Program Administrator shall, with respect to any proposed rule under this para-
p.001721: graph—
p.001721: (i) publish such proposed rule in accordance with section 553 of title 5, United States Code; and
p.001721: (ii) provide interested parties a period of 30 days after such publication to submit written comments on
p.001721: the proposed rule.
p.001721: The WTC Program Administrator may extend the period described in clause (ii) upon a finding of good cause. In
p.001721: the case of such an extension, the Administrator shall publish such extension in the Federal Register.
p.001721: (E) INTERESTED PARTY DEFINED.—For purposes of this paragraph, the term ‘‘interested party’’ includes a
p.001721: rep- resentative of any organization representing WTC respond- ers, a nationally recognized medical association, a
p.001721: Clinical or Data Center, a State or political subdivision, or any other interested person.
p.001721: (F) INDEPENDENT PEER REVIEWS.—Prior to issuing a final rule to add a health condition to the list in paragraph
p.001721: (3), the WTC Program Administrator shall provide for an independent peer review of the scientific and technical
p.001721: evi- dence that would be the basis for issuing such final rule.
p.001721: (G) ADDITIONAL ADVISORY COMMITTEE RECOMMENDA- TIONS.—
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p.001721: January 30, 2020
p.001721: (i) PROGRAM POLICIES.—
p.001721: (I) EXISTING POLICIES.—Not later than 1 year after the date of enactment of the James Zadroga 9/11 Health and
p.001721: Compensation Reauthorization Act, the WTC Program Administrator shall re- quest the Advisory Committee
p.001721: to review and evaluate the policies and procedures, in effect at the time of the review and
p.001721: evaluation, that are used to determine whether sufficient evidence ex- ists to support adding a health
p.001721: condition to the list in paragraph (3).
p.001721: (II) SUBSEQUENT POLICIES.—Prior to estab- lishing any substantive new policy or procedure used to make
p.001721: the determination described in sub- clause (I) or prior to making any substantive amendment to any
...

p.001733: law or plan, including line of duty compensation, to which New York City is obligated to make payments,
p.001733: if, in accordance with terms specified under the contract under subsection (d)(1)(A), New York City has made
p.001733: the full payment required under such contract for such quarter.
p.001733: (3) RULES OF CONSTRUCTION.—Nothing in this title shall be construed to affect, modify, or relieve any
p.001733: obligations under a worker’s compensation law or plan, other work-related injury or illness benefit plan of an
p.001733: employer, or any health insurance plan.
p.001733: (c) HEALTH INSURANCE COVERAGE.—
p.001733: (1) IN GENERAL.—In the case of an individual who has a WTC-related health condition that is not work-related
p.001733: and has health coverage for such condition through any public or pri- vate health plan (including health
p.001733: benefits under title XVIII, XIX, or XXI of the Social Security Act) the provisions of section 1862(b) of the Social
p.001733: Security Act shall apply to such a health plan and such individual in the same manner as they apply to group health
p.001733: plan and an individual entitled to benefits under title XVIII of such Act pursuant to section 226(a) of such
p.001733: Act. Any costs for items and services covered under such plan that are not reimbursed by such health plan, due to the
p.001733: application of deductibles, copayments, coinsurance, other cost sharing, or otherwise, are reimbursable under
p.001733: this title to the extent that they are covered under the WTC Program. The program under this title shall not be treated
p.001733: as a legally liable party for pur- poses of applying section 1902(a)(25) of the Social Security Act.
p.001733: (2) RECOVERY BY INDIVIDUAL PROVIDERS.—Nothing in para- graph (1) shall be construed as requiring an entity
p.001733: providing monitoring and treatment under this title to seek reimburse- ment under a health plan with
p.001733: which the entity has no con- tract for reimbursement.
p.001733: (3) MAINTENANCE OF REQUIRED MINIMUM ESSENTIAL COV- ERAGE.—No payment may be made for monitoring and
p.001733: treat- ment under this title for an individual for a month (beginning with July 2014) if with respect to such month the
p.001733: individual—
p.001733: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001733:
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p.001733: Sec. 3331 PUBLIC HEALTH SERVICE ACT 1734
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p.001733:
p.001733: (A) is an applicable individual (as defined in sub- section (d) of section 5000A of Internal Revenue
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p.001735: (B) bill such amount directly to New York City; and
p.001735: (C) certify periodically, for purposes of this subsection, whether or not New York City has paid the amount
p.001735: so billed.
p.001735: Such amount shall initially be estimated by the WTC Program Administrator and shall be subject to adjustment and
p.001735: reconcili- ation based upon actual expenditures in carrying out this title.
p.001735: (3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed as authorizing the WTC Administrator,
p.001735: with respect to a fiscal year, to reduce the numerical limitation under section 3311(a)(4) or 3321(a)(3)
p.001735: for such fiscal year if New York City fails to comply with paragraph (1) for a cal- endar quarter in
p.001735: such fiscal year.
p.001735: (e) WORK-RELATED DESCRIBED.—For the purposes of this sec- tion, a WTC-related health condition shall be treated
p.001735: as a condition that is work-related if—
p.001735: (1) the condition is diagnosed in an enrolled WTC re- sponder, or in an individual who qualifies as a
p.001735: certified-eligible WTC survivor on the basis of being a rescue, recovery, or cleanup worker; or
p.001735: (2) with respect to the condition the individual has filed and had established a claim under a workers’
p.001735: compensation law or plan of the United States or a State, or other work-re- lated injury or illness
p.001735: benefit plan of the employer of such indi- vidual.
p.001735: SEC. 3332. ø42 U.S.C. 300mm–42¿ ADMINISTRATIVE ARRANGEMENT AU- THORITY.
p.001735: The WTC Program Administrator may enter into arrange- ments with other government agencies, insurance
p.001735: companies, or other third-party administrators to provide for timely and accurate processing of claims under sections
p.001735: 3312, 3313, 3322, and 3323.
p.001735:
p.001735:
p.001735: January 30, 2020 As Amended Through P.L. 116-94,
p.001735: Enacted December 20, 2019
p.001735:
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p.001735: Sec. 3341 PUBLIC HEALTH SERVICE ACT
p.001735:
p.001735: Subtitle C—Research Into Conditions
p.001736: 1736
p.001736:
p.001736: SEC. 3341. ø42 U.S.C. 300mm–51¿ RESEARCH REGARDING CERTAIN HEALTH CONDITIONS RELATED TO SEPTEMBER 11
p.001736: TER- RORIST ATTACKS.
p.001736: (a) IN GENERAL.—With respect to individuals, including en- rolled WTC responders and certified-eligible WTC
p.001736: survivors, receiv- ing monitoring or treatment under subtitle B, the WTC Program Administrator shall conduct
p.001736: or support—
p.001736: (1) research on physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;
p.001736: (2) research on diagnosing WTC-related health conditions of such individuals, in the case of conditions
p.001736: for which there has been diagnostic uncertainty; and
p.001736: (3) research on treating WTC-related health conditions of such individuals, in the case of conditions for which
p.001736: there has been treatment uncertainty.
p.001736: The Administrator may provide such support through continuation and expansion of research that was initiated before the
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p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
p.000001: applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive
p.000001: depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for
p.000001: the government of the service to which detailed.
p.000001: (b) Upon the request of any State health authority or, in the case of work relating to mental health, any
p.000001: State mental health au-
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 7 Former section 213 was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Section 415(c) of title 37, United
p.000001: States Code, now applies to the matter with which former section 213 was concerned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 21 PUBLIC HEALTH SERVICE ACT Sec. 216
p.000001:
p.000001: thority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such
p.000001: State or political subdivi- sion thereof in work related to the functions of the Service.
p.000001: (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to
p.000001: nonprofit edu- cational research or other institutions engaged in health activities for special studies of
p.000001: scientific problems and for the dissemination of information relating to public health.
p.000001: (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the
p.000001: Service except that, in accordance with regulations such personnel may be placed on leave without pay and paid
p.000001: by the State, subdivision, or institution to which they are detailed. In the case of detail of
p.000001: personnel under subsections (b) or (c) to be paid from applicable Service appropria- tions, the Secretary may
p.000001: condition such detail on an agreement by the State, subdivision, or institution concerned that such State,
p.000001: subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by
p.000001: the Service. The services of personnel while detailed pursuant to this section shall be considered as having
p.000001: been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa-
p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
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p.000001: section.
p.000001: (d) The Attorney General may compromise or settle any claim asserted in such civil action or proceeding in the
p.000001: manner provided in section 2677 of title 28 and with the same effect.
p.000001: (e) For purposes of this section, the provisions of section 2680(h) of title 28 shall not apply to
p.000001: assault or battery arising out of negligence in the performance of medical, surgical, dental, or re-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 27 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: lated functions, including the conduct of clinical studies or inves- tigations.
p.000001: (f) The Secretary or his designee may, to the extent that he deems appropriate, hold harmless or provide
p.000001: liability insurance for any officer or employee of the Public Health Service for damage for personal injury, including
p.000001: death, negligently caused by such officer or employee while acting within the scope of his office or employ-
p.000001: ment and as a result of the performance of medical, surgical, den- tal, or related functions, including the conduct of
p.000001: clinical studies or investigations, if such employee is assigned to a foreign country or detailed to a State or
p.000001: political subdivision thereof or to a non-profit institution, and if the circumstances are such as are likely
p.000001: to pre- clude the remedies of third persons against the United States de- scribed in section 2679(b) of
p.000001: title 28, for such damage or injury.
p.000001: (g)(1)(A) For purposes of this section and subject to the ap- proval by the Secretary of an application under
p.000001: subparagraph (D), an entity described in paragraph (4), and any officer, governing board member, or
p.000001: employee of such an entity, and any contractor of such an entity who is a physician or other licensed
p.000001: or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the Public
p.000001: Health Service for a calendar year that begins during a fiscal year for which a transfer was made under
p.000001: subsection (k)(3) (subject to paragraph (3)). The remedy against the United States for an entity
p.000001: described in paragraph (4) and any officer, governing board member, employee, or contractor (subject to
p.000001: paragraph (5)) of such an entity who is deemed to be an employee of the Public Health Service pursuant
p.000001: to this para- graph shall be exclusive of any other civil action or proceeding to the same extent as the
p.000001: remedy against the United States is exclu- sive pursuant to subsection (a).
p.000001: (B) The deeming of any entity or officer, governing board mem- ber, employee, or contractor of the entity to be an
p.000001: employee of the Public Health Service for purposes of this section shall apply with respect to services provided—
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p.000001:
p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 40
p.000001:
p.000001: (A) COVERED COUNTERMEASURE.—The term ‘‘covered countermeasure’’ or ‘‘covered countermeasure against
p.000001: smallpox’’, means a substance that is—
p.000001: (i)(I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or
p.000001: (II) 12 used to control or treat the adverse ef- fects of vaccinia inoculation or of administration of another
p.000001: covered countermeasure; and
p.000001: (ii) specified in a declaration under paragraph (2).
p.000001: (B) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration of a covered
p.000001: countermeasure, means a person who is—
p.000001: (i) a manufacturer or distributor of such counter- measure;
p.000001: (ii) a health care entity under whose auspices 13—
p.000001: (I) such countermeasure was administered;
p.000001: (II) a determination was made as to whether, or under what circumstances, an individual should receive a
p.000001: covered countermeasure;
p.000001: (III) the immediate site of administration on the body of a covered countermeasure was mon- itored,
p.000001: managed, or cared for; or
p.000001: (IV) an evaluation was made of whether the administration of a countermeasure was effective;
p.000001: (iii) a qualified person who administered such countermeasure;
p.000001: (iv) a State, a political subdivision of a State, or an agency or official of a State or of such a
p.000001: political subdivision, if such State, subdivision, agency, or offi- cial has established requirements,
p.000001: provided policy guidance, supplied technical or scientific advice or as- sistance, or otherwise supervised
p.000001: or administered a program with respect to administration of such coun- termeasures;
p.000001: (v) in the case of a claim arising out of alleged transmission of vaccinia from an individual—
p.000001: (I) the individual who allegedly transmitted the vaccinia, if vaccinia vaccine was administered to such individual
p.000001: as provided by paragraph (2)(B) and such individual was within a category of indi- viduals covered by a declaration
p.000001: under paragraph (2)(A)(i); or
p.000001: (II) an entity that employs an individual de- scribed by clause (I) or where such individual has privileges or
p.000001: is otherwise authorized to provide health care;
p.000001: (vi) an official, agent, or employee of a person de- scribed in clause (i), (ii), (iii), or (iv);
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 12 Indentation is so in law. See section 3(e) of Public Law 108–20 (117 Stat. 647).
p.000001: 13 Clause (ii) is shown according to the probable intent of the Congress. In amending the clause to
p.000001: create a subclause (I), section 3(f)(2)(B) of Public Law 108–20 (117 Stat. 647) provided that the clause is amended by
p.000001: redesignating certain words ‘‘as clause (I) and indenting accord- ingly’’. The reference in the amendatory instructions
p.000001: to ‘‘clause (I)’’ probably should be to ‘‘sub- clause (I)’’, and the use in the instructions of the word
p.000001: ‘‘accordingly’’ requires the exercise of editorial judgment.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
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p.000017: (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and
p.000017: (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there
p.000017: is rea- sonable evidence that indicates that such factors or types may be different for women.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 311 PUBLIC HEALTH SERVICE ACT 90
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000017: PART B—FEDERAL-STATE COOPERATION
p.000017: IN GENERAL
p.000017: SEC. 311. ø243¿ (a) The Secretary is authorized to accept from State and local authorities any assistance in the
p.000017: enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and
p.000017: willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and
p.000017: suppression of communicable diseases and with respect to other public health matters, shall cooperate with and
p.000017: aid State and local authorities in the enforcement of their quarantine and other health regulations, and
p.000017: shall advise the several States on matters relating to the preservation and improvement of the public health.
p.000017: (b) The Secretary shall encourage cooperative activities be- tween the States with respect to
p.000017: comprehensive and continuing planning as to their current and future health needs, the establish- ment and
p.000017: maintenance of adequate public health services, and oth- erwise carrying out the public health activities. The
p.000017: Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private
p.000017: entities reasonable fees for the training of their personnel under the preceding sentence.
p.000017: (c)(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a
p.000017: plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies
p.000017: under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or con- dition
p.000017: and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the
p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
p.000017:
p.000017:
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p.000017: January 30, 2020
p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
p.000017: (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the
p.000017: manufac- turers of the devices;
p.000017: (4) by providing training to members of the public in cardiopulmonary resuscitation and automated
p.000017: external defibrillation;
p.000017: (5) by integrating the emergency medical services system with the public access defibrillation programs so
p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
p.000017:
p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
p.000017: (7) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (d) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a State, political subdivision
p.000017: of a State, Indian tribe, or tribal organization shall prepare and submit an appli- cation to the Secretary at such
p.000017: time, in such manner, and con- taining such information as the Secretary may reasonably re- quire.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) shall—
p.000017: (A) describe the comprehensive public access defibrillation program to be funded with the
p.000017: grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to
p.000017: cardiac ar- rest victims in the community;
p.000017: (B) contain procedures for implementing appropriate nationally recognized training courses in
p.000017: performing cardiopulmonary resuscitation and the use of automated external defibrillators;
p.000017: (C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with
p.000017: the local emergency medical services system in the over- sight of training and notification of incidents of the
p.000017: use of the automated external defibrillators;
p.000017: (D) contain procedures for proper maintenance and testing of the automated external defibrillators,
p.000017: according to the labeling of the manufacturer;
p.000017: (E) contain procedures for ensuring notification of local emergency medical services system personnel, including
p.000017: dispatchers, of the location and type of devices used in the public access defibrillation program; and
p.000017: (F) provide for the collection of data regarding the ef- fectiveness of the public access defibrillation
p.000017: program to be funded with the grant in affecting the out-of-hospital car- diac arrest survival rate.
p.000017: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated
p.000017: $25,000,000 for for 6 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts
p.000017: received under a grant awarded under this section may be used for administrative expenses.
p.000017: SEC. 313. ø245¿ PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal
p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
p.000017:
p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
p.000017: providing pub- lic access to automated external defibrillation; and
p.000017: (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded
p.000017: with the grant in—
p.000017: (i) providing emergency cardiopulmonary resus- citation and automated external defibrillation to car- diac
p.000017: arrest victims in the setting served by the dem- onstration project; and
p.000017: (ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000017: $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received
p.000017: under a grant awarded under this section may be used for administrative expenses.
p.000017:
p.000017:
p.000017:
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p.000017: (e) SUNSET.—The demonstration program under this section shall not exceed 5 years.
p.000017: FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
p.000017: SEC. 316. 8 ø247a¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute
p.000017: of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the
p.000017: establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to
p.000017: assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of
p.000017: such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
p.000017: (1) university medical centers and other appropriate health care facilities which receive Federal funds from the
p.000017: Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such
p.000017: disease; and
p.000017: (2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
p.000017: (b) The Secretary shall promote the establishment of a national network to coordinate the family support groups
p.000017: described in sub- section (a).
p.000017: PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES
p.000017: SEC. 317. ø247b¿ (a) The Secretary may make grants to States, and in consultation with State health authorities,
p.000017: to political sub- divisions of States and to other public entities to assist them in
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 8 With respect to section 315, subsection (d) of such section provided as follows: ‘‘This section shall cease to exist
p.000017: on March 31, 1989.’’. See section 1 of Public Law 100–471 (102 Stat. 2284).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: Sec. 317 PUBLIC HEALTH SERVICE ACT 100
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017:
p.000017: meeting the costs of establishing and maintaining preventive health service programs.
p.000017: (b) No grant may be made under subsection (a) unless an ap- plication therefor has been submitted to, and
p.000017: approved by, the Sec- retary. Such an application shall be in such form and be submitted in such manner as the
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p.000101: of and at the re- quest of such grant recipient and for the purpose of carrying out a program with
p.000101: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall
p.000101: be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in
p.000101: detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of
p.000101: the grant and shall be deemed to have been paid to the grant recipient.
p.000101: (f)(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation
p.000101: prescribe, includ- ing records which fully disclose the amount and disposition by such recipient of the proceeds of
p.000101: such grant, the total cost of the under- taking in connection with which such grant was made, and the amount
p.000101: of that portion of the cost of the undertaking supplied by other sources, and such other records as will
p.000101: facilitate an effective audit.
p.000101: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000101: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000101: records of the recipient of grants under sub- section (a) that are pertinent to such grants.
p.000101: (g)(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to
p.000101: a State or to an agency or a political subdivision of a State under provisions of Federal law (other
p.000101: than this section) and which are available for the conduct of
p.000101: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000101: Sec. 317 PUBLIC HEALTH SERVICE ACT 102
p.000101:
p.000101: preventive health service programs from being used on connection with programs assisted through grants under
p.000101: subsection (a).
p.000101: (2) Nothing in this section shall be construed to require any State or any agency or political
p.000101: subdivision of a State to have a preventive health service program which would require any person, who objects to
p.000101: any treatment provided under such a program, to be treated or to have any child or ward treated under such
p.000101: program.
p.000101: (h) The Secretary shall include, as part of the report required by section 1705, a report on the
p.000101: extent of the problems presented by the diseases and conditions referred to in subsection (j) on the
p.000101: amount of funds obligated under grants under subsection (a) in the preceding fiscal year for each of the
p.000101: programs listed in subsection (j); and on the effectiveness of the activities assisted under grants under
p.000101: subsection (a) in controlling such diseases and conditions.
p.000101: (i) The Secretary may provide technical assistance to States, State health authorities, and other public
p.000101: entities in connection with the operation of their preventive health service programs.
p.000101: (j)(1) Except for grants for immunization programs the author- ization of appropriations for which are
p.000101: established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to
p.000101: immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are
p.000101: author- ized to be appropriated such sums as may be necessary. Not more than 10 percent ot the total amount
p.000101: appropriated under the pre- ceding sentence for any fiscal year shall be available for grants under
p.000101: subsection (k)(1) for such fiscal year.
p.000101: (2) For grants under subsection (a) for preventive health serv- ice programs for the provision without charge of
p.000101: immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be
p.000101: appropriated such sums as may be nec- essary.
p.000101: (k)(1) The Secretary may make grants to States, political sub- divisions of States, and other public and
p.000101: nonprofit private entities for—
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p.000101: (A) research into the prevention and control of diseases that may be prevented through vaccination;
p.000101: (B) demonstration projects for the prevention and control of such diseases;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000101: diseases for health professionals (including allied health personnel).
p.000101: (2) The Secretary may make grants to States, political subdivi- sions of States, and other public and nonprofit private
p.000101: entities for—
p.000101: (A) research into the prevention and control of diseases and conditions;
p.000101: (B) demonstration projects for the prevention and control of such diseases and conditions;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases and conditions; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases
p.000101: and con-
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p.000103: PUBLIC HEALTH SERVICE ACT
p.000103: Sec. 317
p.000103:
p.000103: ditions for health professionals (including allied health per- sonnel).
p.000103: (3) No grant may be made under this subsection unless an ap- plication therefor is submitted to the Secretary in
p.000103: such form, at such time, and containing such information as the Secretary may by regulation prescribe.
p.000103: (4) Subsections (d), (e), and (f) shall apply to grants under this subsection in the same manner as such subsections
p.000103: apply to grants under subsection (a).
p.000103: (l) AUTHORITY TO PURCHASE RECOMMENDED VACCINES FOR
p.000103: ADULTS.—
p.000103: (1) IN GENERAL.—The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the
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p.000103: (H) any combination of one or more interventions de- scribed in this paragraph; or
p.000103: (I) immunization information systems to allow all States to have electronic databases for
p.000103: immunization records.
p.000103: (4) CONSIDERATION.—In awarding grants under this sub- section, the Secretary shall consider any
p.000103: reviews or rec- ommendations of the Task Force on Community Preventive Services.
p.000103: (5) EVALUATION.—Not later than 3 years after the date on which a State receives a grant under this subsection, the
p.000103: State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage
p.000103: rates among high- risk populations within the State.
p.000103: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Affordable Health Choices
p.000103: Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program
p.000103: established under this subsection together with recommendations on whether to continue and expand such program.
p.000103: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection, such
p.000103: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000103: SCREENINGS, REFERRALS, AND EDUCATION REGARDING LEAD POISONING
p.000103: SEC. 317A. ø247b–1¿ (a) AUTHORITY FOR GRANTS.—
p.000103: (1) IN GENERAL.—Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease
p.000103: Control and Prevention, may make grants to States and political sub- divisions of States for the
p.000103: initiation and expansion of commu- nity programs designed—
p.000103: (A) to provide, for infants and children—
p.000103: (i) screening for elevated blood lead levels;
p.000103: (ii) referral for treatment of such levels; and
p.000103: (iii) referral for environmental intervention associ- ated with such levels; and
p.000103: (B) to provide education about childhood lead poi- soning.
p.000103: (2) AUTHORITY REGARDING CERTAIN ENTITIES.—With re- spect to a geographic area with a need for activities
p.000103: authorized in paragraph (1), in any case in which neither the State nor the political subdivision in
p.000103: which such area is located has ap- plied for a grant under paragraph (1), the Secretary may make
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: 105
p.000105: PUBLIC HEALTH SERVICE ACT
p.000105: Sec. 317A
p.000105:
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p.000105: a grant under such paragraph to any grantee under section 329, 330, or 340A for carrying out such
p.000105: activities in the area.
p.000105: (3) PROVISION OF ALL SERVICES AND ACTIVITIES THROUGH EACH GRANTEE.—In making grants under paragraph (1),
p.000105: the Secretary shall ensure that each of the activities described in such paragraph is provided through
p.000105: each grantee under such paragraph. The Secretary may authorize such a grantee to pro- vide the services and
p.000105: activities directly, or through arrange- ments with other providers.
p.000105: (b) STATUS AS MEDICAID PROVIDER.—
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p.000117: Department of Health and Human Services.
p.000117: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000117: pay- ments under the grant under subsection (a) to the appli- cant involved by an amount equal to the costs
p.000117: of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any
p.000117: supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses
p.000117: incurred in complying with such request, expend the amounts withheld.
p.000117: (k) DEFINITION.—For purposes of this section, the term ‘‘units of local government’’ includes Indian tribes.
p.000117: (l) AUTHORIZATION OF APPROPRIATIONS.—
p.000117: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000117: $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.
p.000117: (2) ALLOCATION FOR TECHNICAL ASSISTANCE.—Of the amounts appropriated under paragraph (1) for a
p.000117: fiscal year, the Secretary shall reserve not more than 20 percent for car- rying out subsection (j)(1).
p.000117:
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p.000117: January 30, 2020
p.000117: NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS
p.000117: SEC. 317E. ø247b–6¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000117: Control and Pre- vention, may make grants to States, political subdivisions, and other public entities for
p.000117: preventive health service programs for the prevention, control, and elimination of tuberculosis.
p.000117: (b) RESEARCH AND DEVELOPMENT; DEMONSTRATION PROJECTS; EDUCATION AND TRAINING.—With respect to the
p.000117: prevention, treat- ment, control, and elimination of tuberculosis, the Secretary may, directly or through
p.000117: grants to public or nonprofit private entities, carry out the following:
p.000117: (1) Research, with priority given to research and develop- ment concerning latent tuberculosis infection,
p.000117: strains of tuber- culosis resistant to drugs, and research concerning cases of tu- berculosis that affect certain
p.000117: populations at risk for tuber- culosis.
p.000117: (2) Research and development and related activities to de- velop new tools for the elimination of tuberculosis,
p.000117: including
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000117: Sec. 317E PUBLIC HEALTH SERVICE ACT 118
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p.000121: elimination;
p.000121: (D) members from the general public who are knowl- edgeable with respect to tuberculosis including individuals
p.000121: who have or have had tuberculosis; and
p.000121: (E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign
p.000121: country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and
p.000121: disciplines relevant to the research under consideration.
p.000121: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000121:
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p.000121: Sec. 317F PUBLIC HEALTH SERVICE ACT 122
p.000121:
p.000121: (1) GENERAL PROGRAM.—
p.000121: (A) IN GENERAL.—For the purpose of carrying out this section, there are authorized to be appropriated
p.000121: $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011,
p.000121: $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013.
p.000121: (B) RESERVATION FOR EMERGENCY GRANTS.—Of the amounts appropriated under subparagraph (A) for a fiscal year,
p.000121: the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geo-
p.000121: graphic area, State, political subdivision of a State, or other public entity in which there is,
p.000121: relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant
p.000121: tuberculosis, or extensively drug re- sistant tuberculosis or a substantial rate of increase in such cases.
p.000121: (C) PRIORITY.—In allocating amounts appropriated under subparagraph (A), the Secretary shall give
p.000121: priority to allocating such amounts for grants under subsection (a).
p.000121: (D) ALLOCATION OF FUNDS.—
p.000121: (i) REQUIREMENT OF FORMULA.—Of the amounts appropriated under subparagraph (A), not reserved under
p.000121: subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall
p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
p.000121:
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p.000139: not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every
p.000139: 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied
p.000139: with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the
p.000139: month for which the report is being submitted to bring the Secretary into compliance with such sentence, and
p.000139: the anticipated date the Secretary expects to be in full compliance with such sentence.
p.000139: (4) CONSULTATION WITH NONPROFIT GYNECOLOGIC CANCER ORGANIZATIONS.—In carrying out the national campaign under this
p.000139: subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a
p.000139: mission both to con- quer ovarian or other gynecologic cancer and to provide out- reach to State and local
p.000139: governments and communities, for the purpose of determining the best practices for providing gynecologic
p.000139: cancer information and outreach services to varied populations.
p.000139: (6) 14 AUTHORIZATION OF APPROPRIATIONS.—For the pur- pose of carrying out this subsection, there is
p.000139: authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000
p.000139: for the period of fiscal years 2012 through 2014.
p.000139: SEC. 317Q. ø247b–18¿ SURVEILLANCE AND RESEARCH REGARDING MUSCULAR DYSTROPHY.
p.000139: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award
p.000139: grants and cooperative agreements to public or nonprofit private entities (including health departments of
p.000139: States and political subdivisions of States, and including universities and other educational entities) for the
p.000139: collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In making such
p.000139: awards, the Secretary may provide direct technical assistance in lieu of cash.
p.000139: (b) NATIONAL MUSCULAR DYSTROPHY EPIDEMIOLOGY PRO- GRAM.—The Secretary, acting through the Director
p.000139: of the Centers for Disease Control and Prevention, may award grants to public or nonprofit private entities
p.000139: (including health departments of States and political subdivisions of States, and including universities and other
p.000139: educational entities) for the purpose of carrying out epidemio- logical activities regarding Duchenne and other
p.000139: forms of muscular dystrophies, including collecting and analyzing information on the number, incidence,
p.000139: correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary shall provide
p.000139: for a na- tional surveillance program and, to the extent possible, ensure that data be representative of all
p.000139: affected populations and shared in a timely manner. In making awards under this subsection, the Sec-
p.000139: retary may provide direct technical assistance in lieu of cash.
p.000139: (c) COORDINATION WITH CENTERS OF EXCELLENCE.—The Sec- retary shall ensure that epidemiological
p.000139: information under sub- sections (a) and (b) is made available to centers of excellence sup- ported under
p.000139: section 404E(b) by the Director of the National Insti- tutes of Health.
p.000139:
p.000139:
p.000139:
p.000139: January 30, 2020
p.000139: 14 So in law. There is no paragraph (5).
p.000139:
p.000139: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000141: 141
p.000141: PUBLIC HEALTH SERVICE ACT
p.000141: Sec. 317S
p.000141:
p.000141: (d) DATA.—In carrying out this section, the Secretary may en- sure that any data on patients that is collected
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p.000141: year for which the report is prepared;
p.000141: (B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as
p.000141: funded under a grant under this section during fiscal years 2008 through 2012); and
p.000141: (C) that every 2 years outlines prospective data collec- tion objectives and strategies.
p.000141: (2) TRACKING HEALTH OUTCOMES.—The Secretary may pro- vide health outcome data on the health and survival of people
p.000141: with muscular dystrophy.
p.000141: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary to
p.000141: carry out this section.
p.000141: SEC. 317R. ø247b–20¿ FOOD SAFETY GRANTS.
p.000141: (a) IN GENERAL.—The Secretary may award grants to States and Indian tribes (as defined in section 4(e) of the
p.000141: Indian Self-De- termination and Education Assistance Act (25 U.S.C. 450b(e))) to expand participation in
p.000141: networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and
p.000141: maintaining the food safety surveillance, technical, and labora- tory capacity needed for such participation.
p.000141: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000141: to be appropriated
p.000141: $19,500,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011
p.000141: through 2015.
p.000141: SEC. 317S. ø247b–21¿ MOSQUITO-BORNE DISEASES; COORDINATION GRANTS TO STATES; ASSESSMENT AND CONTROL GRANTS TO
p.000141: POLITICAL SUBDIVISIONS.
p.000141: (a) COORDINATION GRANTS TO STATES; ASSESSMENT GRANTS TO
p.000141: POLITICAL SUBDIVISIONS.—
p.000141: (1) IN GENERAL.—With respect to mosquito control pro- grams to prevent and control mosquito-borne diseases
p.000141: (referred to in this section as ‘‘control programs’’), the Secretary, acting through the Director of the
p.000141: Centers for Disease Control and Prevention, may make grants to States for the purpose of—
p.000141: (A) coordinating control programs in the State in- volved; and
p.000141: (B) assisting such State in making grants to political subdivisions of the State to conduct assessments
p.000141: to deter-
p.000141:
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p.000141: January 30, 2020
p.000141: 15 So in law. The term ‘‘site’’ probably should be ‘‘sites’’.
p.000141: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000141: Sec. 317S PUBLIC HEALTH SERVICE ACT 142
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p.000141: mine the immediate needs in such subdivisions for control programs, including programs to address emerging infec-
p.000141: tious mosquito-borne diseases, and to develop, on the basis of such assessments, plans for carrying out control
p.000141: pro- grams in the subdivisions or improving existing control programs.
p.000141: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.000141: preference to States that have one or more political subdivisions with an in- cidence, prevalence, or high risk
p.000141: of mosquito-borne disease, or a population of infected mosquitoes, that is substantial relative to political
p.000141: subdivisions in other States.
p.000141: (3) CERTAIN REQUIREMENTS.—A grant may be made under paragraph (1) only if—
p.000141: (A) the State involved has developed, or agrees to de- velop, a plan for coordinating control programs
p.000141: in the State, and the plan takes into account any assessments or plans described in subsection (b)(3) that have
p.000141: been con- ducted or developed, respectively, by political subdivisions in the State;
p.000141: (B) in developing such plan, the State consulted or will consult (as the case may be under subparagraph (A)) with
p.000141: political subdivisions in the State that are carrying out or planning to carry out control programs;
p.000141: (C) the State agrees to monitor control programs in the State in order to ensure that the programs are carried
p.000141: out in accordance with such plan, with priority given to co- ordination of control programs in political subdivisions
p.000141: de- scribed in paragraph (2) that are contiguous;
p.000141: (D) the State agrees that the State will make grants to political subdivisions as described in paragraph
p.000141: (1)(B), and that such a grant will not exceed $10,000; and
p.000141: (E) the State agrees that the grant will be used to sup- plement, and not supplant, State and local funds available for
p.000141: the purpose described in paragraph (1).
p.000141: (4) REPORTS TO SECRETARY.—A grant may be made under paragraph (1) only if the State involved agrees
p.000141: that, promptly after the end of the fiscal year for which the grant is made, the State will submit to the Secretary a
p.000141: report that—
p.000141: (A) describes the activities of the State under the grant; and
p.000141: (B) contains an evaluation of whether the control pro- grams of political subdivisions in the State were effectively
p.000141: coordinated with each other, which evaluation takes into account any reports that the State received
p.000141: under sub- section (b)(5) from such subdivisions.
p.000141: (5) NUMBER OF GRANTS.—A State may not receive more than one grant under paragraph (1).
p.000141: (b) PREVENTION AND CONTROL GRANTS TO POLITICAL SUBDIVI-
p.000141: SIONS.—
p.000141:
p.000141:
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p.000141: January 30, 2020
p.000141: (1) IN GENERAL.—The Secretary, acting through the Direc-
p.000141: tor of the Centers for Disease Control and Prevention, may make grants to political subdivisions of
p.000141: States or consortia of
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p.000143: PUBLIC HEALTH SERVICE ACT
p.000143: Sec. 317S
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p.000143: political subdivisions of States, for the operation, including im- provement, of control programs.
p.000143: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.000143: preference to a political subdivision or consortium of political subdivisions that—
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p.000143: (A) has—
p.000143: (i) a history of elevated incidence or prevalence of mosquito-borne disease;
p.000143: (ii) a population of infected mosquitoes;
p.000143: (iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence
p.000143: or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-
p.000143: borne disease that presents a serious public health threat; or
p.000143: (iv) a public health emergency due to the inci- dence or prevalence of a mosquito-borne disease that
p.000143: presents a serious public health threat;
p.000143: (B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions
p.000143: will, if appropriate to the mosquito circumstances involved, effec- tively coordinate the activities of the
p.000143: control programs with contiguous political subdivisions;
p.000143: (C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political sub-
p.000143: division or consortium of political subdivisions is located has identified or will identify geographic
p.000143: areas in such State that have a significant need for control programs and will effectively coordinate
p.000143: such programs in such areas; and
p.000143: (D)(i) is located in a State that has received a grant under subsection (a); or
p.000143: (ii) that demonstrates to the Secretary that the control program is consistent with existing State mosquito control
p.000143: plans or policies, or other applicable State preparedness plans.
p.000143: (3) REQUIREMENT OF ASSESSMENT AND PLAN.—A grant may be made under paragraph (1) only if the political
p.000143: subdivision or consortium of political subdivisions involved—
p.000143: (A) has conducted an assessment to determine the im- mediate needs in such subdivision or consortium for a con- trol
p.000143: program, including an entomological survey of poten- tial mosquito breeding areas; and
p.000143: (B) has, on the basis of such assessment, developed a plan for carrying out such a program.
p.000143: (4) REQUIREMENT OF MATCHING FUNDS.—
p.000143: (A) IN GENERAL.—With respect to the costs of a control program to be carried out under paragraph (1) by a
p.000143: polit- ical subdivision or consortium of political subdivisions, a grant under such paragraph may be made only
p.000143: if the sub- division or consortium agrees to make available (directly or through donations from public or
p.000143: private entities) non- Federal contributions toward such costs in an amount that
p.000143: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000143: Sec. 317S PUBLIC HEALTH SERVICE ACT 144
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p.000143: is not less than 1⁄3 of such costs ($1 for each $2 of Federal funds provided in the grant).
p.000143: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions required in subparagraph (A) may be in cash
p.000143: or in kind, fairly evaluated, including plant, equip- ment, or services. Amounts provided by the Federal Gov-
p.000143: ernment, or services assisted or subsidized to any signifi- cant extent by the Federal Government, may
p.000143: not be in- cluded in determining the amount of such non-Federal con- tributions.
p.000143: (C) WAIVER.—The Secretary may waive the require- ment established in subparagraph (A) if the Secretary
p.000143: de- termines that—
p.000143: (i) extraordinary economic conditions in the polit- ical subdivision or consortium of political
p.000143: subdivisions involved justify the waiver; or
p.000143: (ii) the geographical area covered by a political subdivision or consortium for a grant under paragraph
p.000143: (1) has an extreme mosquito control need due to—
p.000143: (I) the size or density of the potentially im- pacted human population;
p.000143: (II) the size or density of a mosquito popu- lation that requires heightened control; or
p.000143: (III) the severity of the mosquito-borne dis- ease, such that expected serious adverse health outcomes for
p.000143: the human population justify the waiver.
p.000143: (5) REPORTS TO SECRETARY.—A grant may be made under paragraph (1) only if the political subdivision or
p.000143: consortium of political subdivisions involved agrees that, promptly after the end of the fiscal year for which
p.000143: the grant is made, the subdivi- sion or consortium will submit to the Secretary, and to the State within
p.000143: which the subdivision or consortium is located, a report that describes the control program and contains an
p.000143: eval- uation of whether the program was effective.
p.000143: (6) NUMBER OF GRANTS.—A political subdivision or a con- sortium of political subdivisions may not receive more
p.000143: than one grant under paragraph (1).
p.000143: (c) APPLICATIONS FOR GRANTS.—A grant may be made under subsection (a) or (b) only if an application for
p.000143: the grant is sub- mitted to the Secretary and the application is in such form, is made in such
p.000143: manner, and contains such agreements, assurances, and information as the Secretary determines to be
p.000143: necessary to carry out this section.
p.000143: (d) TECHNICAL ASSISTANCE.—Amounts appropriated under sub- section (f) may be used by the Secretary to provide
p.000143: training and technical assistance with respect to the planning, development, and operation of assessments and
p.000143: plans under subsection (a) and con- trol programs under subsection (b). The Secretary may provide such
p.000143: technical assistance directly or through awards of grants or contracts to public and private entities.
p.000143: (e) DEFINITION OF POLITICAL SUBDIVISION.—In this section, the term ‘‘political subdivision’’ means the local
p.000143: political jurisdiction immediately below the level of State government, including coun-
p.000143: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000145: PUBLIC HEALTH SERVICE ACT
p.000145: Sec. 317U
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p.000145: January 30, 2020
p.000145: ties, parishes, and boroughs. If State law recognizes an entity of general government that functions in
p.000145: lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the
p.000145: jurisdiction of such other entities of general government as a political subdivision for purposes of this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000145: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000145: $100,000,000 for each of fiscal years 2019 through 2023.
p.000145: (2) PUBLIC HEALTH EMERGENCIES.—In the case of control programs carried out in response to a
p.000145: mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under
p.000145: paragraph (1) is in addition to applica- ble authorizations of appropriations under this Act and other medical
p.000145: and public health preparedness and response laws.
p.000145: (3) FISCAL YEAR 2019 APPROPRIATIONS.—For fiscal year 2019, 50 percent or more of the funds appropriated
p.000145: under para- graph (1) shall be used to award grants to political subdivi- sions or consortia of political
p.000145: subdivisions under subsection (b).
p.000145: SEC. 317T. ø247b–22¿ MICROBICIDE RESEARCH.
p.000145: (a) IN GENERAL.—The Director of the Centers for Disease Con- trol and Prevention is strongly encouraged to fully
p.000145: implement the Centers’ microbicide agenda to support research and development of microbicides for use to
p.000145: prevent the transmission of the human immunodeficiency virus.
p.000145: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for each
p.000145: of fiscal years 2009 through 2013 to carry out this section.
p.000145: SEC. 317U. ø???¿ NATIONAL STRATEGY AND REGIONAL CENTERS OF EXCELLENCE IN VECTOR-BORNE DISEASES.
p.000145: (a) IN GENERAL.—The Secretary shall—
p.000145: (1)(A) ensure the development and implementation of a na- tional strategy to address vector-borne diseases, including
p.000145: tick- borne diseases, that—
p.000145: (i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
p.000145: (ii) identifies strategic goals to address such diseases and appropriate benchmarks to measure progress
p.000145: toward achieving such goals; and
p.000145: (B) update such strategy, as appropriate; and
p.000145: (2) coordinate programs and activities, including related to data collection, research, and the development of
p.000145: diagnostics, treatments, vaccines, and other related activities, to address vector-borne diseases, including
p.000145: tick-borne diseases, across the Department of Health and Human Services and with other Federal agencies or
p.000145: departments, as appropriate.
p.000145: (b) CONSULTATION.—In carrying out subsection (a)(1), the Sec- retary shall consult with the Tick-Borne
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p.000145: receiv- ing such award, and annually thereafter, submit to the Sec- retary a summary of programs and
p.000145: activities funded under the award.
p.000145: (2) PROGRESS REPORT.—Not later than 4 years after the date of enactment of this section, the Secretary shall
p.000145: submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.000145: Commerce of the House of Representatives, a report on the progress made in ad- dressing vector-borne diseases,
p.000145: including tick-borne diseases, through activities carried out under this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000145: to be appropriated
p.000145: $10,000,000 for each of fiscal years 2021 through 2025.
p.000145: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000147: PUBLIC HEALTH SERVICE ACT
p.000147: Sec. 318
p.000147:
p.000147: PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF SEXUALLY TRANSMITTED DISEASES 16
p.000147: SEC. 318. ø247c¿ (a) The Secretary may provide technical as- sistance to appropriate public and non-profit
p.000147: private entities and to scientific institutions for their research in, and training and public health programs for
p.000147: the prevention and control of sexually trans- mitted diseases.
p.000147: (b) The Secretary may make grants to States, political subdivi- sions of States, and any other public and
p.000147: nonprofit private entity for—
p.000147: (1) research into the prevention and control of sexually transmitted diseases;
p.000147: (2) demonstration projects for the prevention and control of sexually transmitted diseases;
p.000147: (3) public information and education programs for the pre- vention and control of such diseases; and
p.000147: (4) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000147: diseases for health professionals (including allied health personnel).
p.000147: (c) The Secretary is also authorized to make project grants to States and, in consultation with the
p.000147: State health authority, to po- litical subdivisions of States, for—
p.000147: (1) sexually transmitted diseases surveillance activities, in- cluding the reporting, screening, and followup of
p.000147: diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
p.000147: (2) casefinding and case followup activities respecting sex- ually transmitted diseases, including contact tracing
p.000147: of infec- tious cases of sexually transmitted diseases and routine test- ing, including laboratory tests and
p.000147: followup systems;
p.000147: (3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
p.000147: (4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and
p.000147: control strat- egies and activities as may be prescribed by the Secretary.
p.000147: (d) The Secretary may make grants to States and political sub- divisions of States for the development,
p.000147: implementation, and eval- uation of innovative, interdisciplinary approaches to the prevention and control of
p.000147: sexually transmitted diseases.
p.000147: (e)(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be
p.000147: appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal
p.000147: years 1995 through 1998.
p.000147: (2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe
p.000147: including records which fully disclose the amount and disposition by such recipient of the
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p.000147: January 30, 2020
p.000147: 16 Title II of Public Law 103–333, an appropriations Act, provides (under the heading relating to the Centers for
p.000147: Disease Control and Prevention; see 108 Stat. 2550) in part as follows: ‘‘That funds appropriated under this heading
p.000147: for fiscal year 1995 and subsequent fiscal years shall be available for payment of the costs of medical care,
p.000147: related expenses, and burial expenses here- after incurred by or on behalf of any person who had
p.000147: participated in the study of untreated syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts
p.000147: and subject to such terms and conditions as prescribed by the Secretary of Health and Human Services and for
p.000147: payment, in such amounts and subject to such terms and conditions, of such costs and expenses hereafter incurred by or
p.000147: on behalf of such person’s wife or offspring determined by the Secretary to have suffered injury or disease from
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p.000147: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000147: records of the recipients of grants under this section that are pertinent to such grants.
p.000147: (4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair
p.000147: market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances,
p.000147: travel expenses, and any other costs in connection with the detail of an officer or employee of the United
p.000147: States to the recipient when the furnishing of such supplies or equipment or the detail of such an
p.000147: officer or employee is for the convenience of and at the request of such recipient and for the pur- pose of
p.000147: carrying out the program with respect to which the grant under this section is made. The amount by
p.000147: which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in
p.000147: furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
p.000147: (5) All information obtained in connection with the examina- tion, care, or treatment of any individual under
p.000147: any program which is being carried out with a grant made under this section shall not, without such individual’s
p.000147: consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a
p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
p.000147: (A) in summary, statistical, or other form; or
p.000147: (B) for clinical or research purposes;
p.000147: but only if the identity of the individuals diagnosed or provided care or treatment under such program is not
p.000147: disclosed.
p.000147: (f) Nothing in this section shall be construed to require any State or any political subdivision of a
p.000147: State to have a sexually transmitted diseases program which would require any person, who objects to any
p.000147: treatment provided under such a program, to be treated under such a program.
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p.000147: January 30, 2020
p.000147: INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
p.000147:
p.000147: SEC. 318A. ø247c–1¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000147: Control and Pre- vention, may make grants to States, political subdivisions of States, and other
p.000147: public or nonprofit private entities for the pur- pose of carrying out the activities described in
p.000147: subsection (c) re- garding any treatable sexually transmitted disease that can cause infertility in women if
p.000147: treatment is not received for the disease.
p.000147: (b) AUTHORITY REGARDING INDIVIDUAL DISEASES.—With re- spect to diseases described in subsection (a), the
p.000147: Secretary shall, in making a grant under such subsection, specify the particular dis- ease or diseases with
p.000147: respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000149: PUBLIC HEALTH SERVICE ACT
p.000149: Sec. 318A
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p.000149: agrees to carry out this section only with respect to the disease or diseases so specified.
p.000149: (c) AUTHORIZED ACTIVITIES.—With respect to any sexually transmitted disease described in subsection
p.000149: (a), the activities re- ferred to in such subsection are—
p.000149: (1) screening women for the disease and for secondary con- ditions resulting from the disease, subject to
p.000149: compliance with criteria issued under subsection (f);
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p.000159: of the in- formation contained in the systems involved may be used to pro- vide proprietary advantage within
p.000159: the vaccine market, while allow- ing State, local, and tribal health officials access to such informa- tion
p.000159: to maximize the delivery and availability of vaccines to high priority populations, during times of
p.000159: influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufac- turers,
p.000159: distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a)
p.000159: and (b).
p.000159: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000159: $30,800,000 for each of fiscal years 2019 through 2023.
p.000159: (f) REPORT TO CONGRESS.—As part of the National Health Se- curity Strategy described in section 2802,
p.000159: the Secretary shall pro- vide an update on the implementation of subsections (a) through (d).
p.000159: SEC. 319C–1. ø247d–3a¿ IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. 17
p.000159: (a) IN GENERAL.—To enhance the security of the United States with respect to public health emergencies, the
p.000159: Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, shall award
p.000159: cooperative agreements to eligible entities to enable such entities to conduct the activities described in
p.000159: sub- section (d).
p.000159: (b) ELIGIBLE ENTITIES.—To be eligible to receive an award under subsection (a), an entity shall—
p.000159: (1)(A) be a State;
p.000159: (B) be a political subdivision determined by the Secretary to be eligible for an award under this section
p.000159: (based on criteria described in subsection (h)(4)); or
p.000159: (C) be a consortium of States; and
p.000159: (2) prepare and submit to the Secretary an application at such time, and in such manner, and containing
p.000159: such informa- tion as the Secretary may require, including—
p.000159: (A) an All-Hazards Public Health Emergency Pre- paredness and Response Plan which shall include—
p.000159: (i) a description of the activities such entity will carry out under the agreement to meet the goals iden-
p.000159: tified under section 2802, including with respect to chemical, biological, radiological, or nuclear
p.000159: threats, whether naturally occurring, unintentional, or delib- erate;
p.000159: (ii) a description of the activities such entity will carry out with respect to pandemic influenza, as
p.000159: a component of the activities carried out under clause (i), and consistent with the requirements of
p.000159: para- graphs (2) and (5) of subsection (g);
p.000159: (iii) preparedness and response strategies and ca- pabilities that take into account the medical and pub-
p.000159:
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p.000159: January 30, 2020
p.000159: 17 Former sections 319B and 319C were repealed by section 204(b)(1) of Public Law 109–417 (120 Stat.
p.000159: 2951).
p.000159: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000167: January 30, 2020
p.000167: sum of all base amounts determined for the States under subparagraph (B), and less the amount, if any,
p.000167: reserved by the Secretary under paragraphs (4) and (5); and
p.000167: (ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the pop- ulation
p.000167: of the State over an amount equal to the total population of the States (as indicated by the most re- cent
p.000167: data collected by the Bureau of the Census).
p.000167: (D) MINIMUM AMOUNT.—Subject to the amount appro- priated under paragraph (1)(A), an award pursuant to sub-
p.000167: paragraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or
p.000167: the min- imum amount under this subparagraph. The minimum amount under this subparagraph is—
p.000167: (i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puer- to
p.000167: Rico, an amount equal to the lesser of—
p.000167: (I) $5,000,000; or
p.000167: (II) if the amount appropriated under para- graph (1)(A) is less than $667,000,000, an amount equal to 0.75
p.000167: percent of the amount appropriated under such paragraph, less the amount, if any, re- served by the Secretary under
p.000167: paragraphs (4) and (5); or
p.000167: (ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the
p.000167: Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not
p.000167: exceed the amount determined under clause (i).
p.000167: (4) CERTAIN POLITICAL SUBDIVISIONS.—
p.000167: (A) IN GENERAL.—For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such
p.000167: year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec-
p.000167: essary by the Secretary to make awards under subsection
p.000167: (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for
p.000167: re- sponding to public health emergencies, and face a high de- gree of risk from bioterrorist attacks or other public
p.000167: health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.
p.000167: (B) COORDINATION WITH STATEWIDE PLANS.—An award pursuant to subparagraph (A) may not be made unless the application
p.000167: of the political subdivision involved is in co- ordination with, and consistent with, applicable Statewide plans
p.000167: described in subsection (b).
p.000167: (C) RELATIONSHIP TO FORMULA GRANTS.—In the case of a State that will receive an award pursuant to paragraph
p.000167: (3), and in which there is located a political subdivision that will receive an award pursuant to
p.000167: subparagraph (A), the Secretary shall, in determining the amount under paragraph (3)(C) for the
p.000167: State, subtract from the popu-
p.000167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000167: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 168
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p.000167: lation of the State an amount equal to the population of such political subdivision.
p.000167: (D) CONTINUITY OF FUNDING.—In determining whether to make an award pursuant to subparagraph (A) to a polit- ical
p.000167: subdivision, the Secretary may consider, as a factor in- dicating that the award should be made, that the political
p.000167: subdivision received public health funding from the Sec- retary for fiscal year 2006.
p.000167: (5) SIGNIFICANT UNMET NEEDS; DEGREE OF RISK.—
p.000167: (A) IN GENERAL.—For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such
p.000167: year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec-
p.000167: essary by the Secretary to make awards under subsection
p.000167: (a) to eligible entities that—
p.000167: (i) have a significant need for funds to build ca- pacity to identify, detect, monitor, and respond to
p.000167: a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3);
p.000167: and
p.000167: (ii) face a particularly high degree of risk of such a threat.
p.000167: (B) RECIPIENTS OF GRANTS.—Awards pursuant to sub- paragraph (A) may be supplemental awards to States that receive
p.000167: awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection
p.000167: (b)(1)(B) within such States.
p.000167: (C) FINDING WITH RESPECT TO DISTRICT OF COLUM- BIA.—The Secretary shall consider the District of Columbia
p.000167: to have a significant unmet need for purposes of subpara- graph (A), and to face a particularly high degree of risk for
p.000167: such purposes, on the basis of the concentration of entities of national significance located within the District.
p.000167: (6) FUNDING OF LOCAL ENTITIES.—The Secretary shall, in making awards under this section, ensure that with
p.000167: respect to the cooperative agreement awarded, the entity make available appropriate portions of such award to
p.000167: political subdivisions and local departments of public health through a process in- volving the consensus,
p.000167: approval or concurrence with such local entities.
p.000167: (7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
p.000167: (A) IN GENERAL.—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for
p.000167: a fiscal year and remaining unobligated at the end of such year shall remain available to such entity
p.000167: for the next fiscal year for the purposes for which such funds were provided.
p.000167: (B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— The continued availability of funds under subparagraph
p.000167: (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the
p.000167: pan- demic influenza plan as described in subsection (g).
p.000167: (i) ADMINISTRATIVE AND FISCAL RESPONSIBILITY.—
p.000167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000169: 169
p.000169: PUBLIC HEALTH SERVICE ACT
p.000169: Sec. 319C–1
p.000169:
p.000169: (1) ANNUAL REPORTING REQUIREMENTS.—Each entity shall prepare and submit to the Secretary annual reports on
p.000169: its ac- tivities under this section and section 319C–2. Each such re- port shall be prepared by, or in
p.000169: consultation with, the health department. In order to properly evaluate and compare the performance of
p.000169: different entities assisted under this section and section 319C–2 and to assure the proper expenditure of
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p.000169: ITY.
p.000169: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award
p.000169: competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity
p.000169: and enhance community and hospital preparedness for, and response to, public health emer- gencies in
p.000169: accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of
p.000169: children and other at-risk individuals.
p.000169: (b) ELIGIBILITY.—To be eligible for an award under subsection (a), an entity shall—
p.000169: (1)(A) be a coalition that includes—
p.000169: (i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with
p.000169: section 1213(c);
p.000169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000171: PUBLIC HEALTH SERVICE ACT
p.000171: Sec. 319C–2
p.000171:
p.000171: (ii) one or more other local health care facilities, in- cluding clinics, health centers, community
p.000171: health centers, primary care facilities, mental health centers, mobile med- ical assets, or nursing homes;
p.000171: (iii)(I) one or more political subdivisions;
p.000171: (II) one or more States; or
p.000171: (III) one or more States and one or more political sub- divisions; and
p.000171: (iv) one or more emergency medical service organiza- tions or emergency management organizations; and
p.000171: (B) prepare, in consultation with the Chief Executive Offi- cer and the lead health officials of the State, District,
p.000171: or terri- tory in which the hospital and health care facilities described in subparagraph (A) are located,
p.000171: and submit to the Secretary, an application at such time, in such manner, and containing such information
p.000171: as the Secretary may require; or
p.000171: (2)(A) be an entity described in section 319C–1(b)(1); and
p.000171: (B) submit an application at such time, in such manner, and containing such information as the Secretary may
p.000171: require, including the information or assurances required under section 319C–1(b)(2) and an assurance that the
p.000171: State will adhere to any applicable guidelines established by the Secretary.
p.000171: (c) USE OF FUNDS.—An award under subsection (a) shall be ex- pended for activities to achieve the preparedness
p.000171: goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to
p.000171: all-hazards, including chemical, biological, radiological, or nuclear threats.
p.000171: (d) PREFERENCES.—
p.000171: (1) REGIONAL COORDINATION.—In making awards under subsection (a), the Secretary shall give preference to
p.000171: eligible entities that submit applications that, in the determination of the Secretary—
p.000171: (A) will enhance coordination—
p.000171: (i) among the entities described in subsection (b)(1)(A)(i);
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p.000171: Sec. 319C–2 PUBLIC HEALTH SERVICE ACT 172
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p.000171: (C) have a significant need for funds to achieve the preparedness and response goals described in
p.000171: section 2802(b)(3).
p.000171: (e) CONSISTENCY OF PLANNED ACTIVITIES.—The Secretary may not award a cooperative agreement to an eligible
p.000171: entity described in subsection (b)(1) unless the application submitted by the entity is coordinated and
p.000171: consistent with an applicable State All-Hazards Public Health Emergency Preparedness and Response Plan and rel- evant
p.000171: local plans, as determined by the Secretary in consultation with relevant State health officials.
p.000171: (f) LIMITATION ON AWARDS.—A political subdivision shall not participate in more than one coalition
p.000171: described in subsection (b)(1).
p.000171: (g) COORDINATION.—
p.000171: (1) LOCAL RESPONSE CAPABILITIES.—An eligible entity shall, to the extent practicable, ensure that
p.000171: activities carried out under an award under subsection (a) are coordinated with activities of relevant local
p.000171: Metropolitan Medical Response Sys- tems, local Medical Reserve Corps, the local Cities Readiness Initiative,
p.000171: and local emergency plans.
p.000171: (2) NATIONAL COLLABORATION.—Coalitions consisting of one or more eligible entities under this section may,
p.000171: to the ex- tent practicable, collaborate with other coalitions consisting of one or more eligible entities under
p.000171: this section for purposes of national coordination and collaboration with respect to activi- ties to achieve
p.000171: the preparedness and response goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).
p.000171: (h) MAINTENANCE OF FUNDING.—
p.000171: (1) IN GENERAL.—An entity that receives an award under this section shall maintain expenditures for
p.000171: health care pre- paredness at a level that is not less than the average level of such expenditures
p.000171: maintained by the entity for the preceding 2 year period.
p.000171: (2) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prohibit the use of awards under
p.000171: this section to pay salary and related expenses of public health and other professionals employed by
p.000171: State, local, or tribal agencies who are carrying out activities supported by such awards (regard- less of
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p.000173: January 30, 2020
p.000173: (i) IN GENERAL.—Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fis- cal
p.000173: year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 319C–3.
p.000173: (ii) RESERVATION CONTINGENT ON CONTINUED AP- PROPRIATIONS FOR THIS SECTION.—If for fiscal year 2019 or
p.000173: a subsequent fiscal year, the amount appro- priated under subparagraph (A) is such that, after ap- plication of
p.000173: clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount
p.000173: available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i)
p.000173: shall be reduced such that the amount re- maining for the purpose of carrying out this section is not less
p.000173: than the amount available for such purpose for the previous fiscal year.
p.000173: (iii) SUNSET.—The authority to reserve amounts under clause (i) shall expire on September 30, 2023.
p.000173: (2) RESERVATION OF AMOUNTS FOR PARTNERSHIPS.—Prior to making awards described in paragraph (3), the
p.000173: Secretary may reserve from the amount appropriated under paragraph (1)(A) for a fiscal year and not reserved
p.000173: for the purpose described in paragraph (1)(B)(i), an amount determined appropriate by the Secretary for making
p.000173: awards to entities described in subsection (b)(1)(A).
p.000173: (3) AWARDS TO STATES AND POLITICAL SUBDIVISIONS.—
p.000173: (A) IN GENERAL.—From amounts appropriated for a fiscal year under paragraph (1)(A) and not reserved under
p.000173: paragraph (1)(B)(i) or (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have
p.000173: com- pleted an application as described in subsection (b)(2)(B).
p.000173: (B) AMOUNT.—The Secretary shall determine the amount of an award to each entity described in
p.000173: subpara- graph (A) in the same manner as such amounts are deter- mined under section 319C–1(h).
p.000173: (4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
p.000173: (A) IN GENERAL.—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for
p.000173: a fiscal year and remaining unobligated at the end of such year shall remain available to such entity
p.000173: for the next fiscal year for the purposes for which such funds were provided.
p.000173: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000173:
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p.000173: Sec. 319C–3 PUBLIC HEALTH SERVICE ACT 174
p.000173:
p.000173: (B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— The continued availability of funds under subparagraph
p.000173: (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the
p.000173: pan- demic influenza plan as required under subsection (i).
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p.000219: January 30, 2020
p.000219:
p.000219: (5) CERTAIN DISCLOSURES.—In publishing a declaration under paragraph (1) in the Federal Register, the
p.000219: Secretary is not required to disclose any matter described in section 552(b) of title 5, United States Code.
p.000219: (6) FACTORS TO BE CONSIDERED.—In deciding whether and under what circumstances or conditions to issue a
p.000219: declaration under paragraph (1) with respect to a covered countermeasure, the Secretary shall consider the desirability
p.000219: of encouraging the design, development, clinical testing or investigation, manufac- ture, labeling, distribution,
p.000219: formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration,
p.000219: licensing, and use of such countermeasure.
p.000219: (7) JUDICIAL REVIEW.—No court of the United States, or of any State, shall have subject matter jurisdiction to
p.000219: review, whether by mandamus or otherwise, any action by the Sec- retary under this subsection.
p.000219: (8) PREEMPTION OF STATE LAW.—During the effective pe- riod of a declaration under subsection (b), or at any
p.000219: time with respect to conduct undertaken in accordance with such declara- tion, no State or political subdivision of a
p.000219: State may establish, enforce, or continue in effect with respect to a covered counter- measure any provision of law or
p.000219: legal requirement that—
p.000219: (A) is different from, or is in conflict with, any require- ment applicable under this section; and
p.000219: (B) relates to the design, development, clinical testing or investigation, formulation, manufacture,
p.000219: distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other
p.000219: aspect of safety or effi- cacy, or the prescribing, dispensing, or administration by qualified persons of
p.000219: the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under
p.000219: this section or any other provision of this Act, or under the Federal Food, Drug, and Cosmetic Act.
p.000219: (9) REPORT TO CONGRESS.—Within 30 days after making a declaration under paragraph (1), the Secretary shall submit to
p.000219: the appropriate committees of the Congress a report that pro- vides an explanation of the reasons for issuing
p.000219: the declaration and the reasons underlying the determinations of the Sec- retary with respect to paragraph
p.000219: (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such
p.000219: committees a report that provides the rea- sons underlying the determination of the Secretary to make the
p.000219: amendment.
p.000219: (c) DEFINITION OF WILLFUL MISCONDUCT.—
p.000219: (1) DEFINITION.—
p.000219: (A) IN GENERAL.—Except as the meaning of such term is further restricted pursuant to paragraph (2), the term
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p.000231: (A) who is in a population specified in such declara- tion, and with respect to whom the administration
p.000231: or use of the covered countermeasure satisfies the other specifica- tions of such declaration; or
p.000231: (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith
p.000231: belief that the individual is in the category described by subparagraph (A).
p.000231: (3) COVERED INJURY.—The term ‘‘covered injury’’ means se- rious physical injury or death.
p.000231: (4) DECLARATION.—The term ‘‘declaration’’ means a dec- laration under section 319F–3(b).
p.000231: (5) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who is determined, in
p.000231: accordance with subsection (b), to be a covered individual who sustains a cov- ered injury.
p.000231: SEC. 319G. ø247d–7¿ DEMONSTRATION PROGRAM TO ENHANCE BIO- TERRORISM TRAINING, COORDINATION, AND READINESS.
p.000231: (a) IN GENERAL.—The Secretary shall make grants to not more than three eligible entities to carry out demonstration
p.000231: programs to improve the detection of pathogens likely to be used in a bioter- rorist attack, the development
p.000231: of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various
p.000231: responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population.
p.000231: Such awards shall be made on a competitive basis and pursuant to scientific and tech- nical review.
p.000231: (b) ELIGIBLE ENTITIES.—Eligible entities for grants under sub- section (a) are States, political subdivisions of
p.000231: States, and public or private non-profit organizations.
p.000231: (c) SPECIFIC CRITERIA.—In making grants under subsection (a), the Secretary shall take into account the following
p.000231: factors:
p.000231: (1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university
p.000231: with exper- tise in scientific training, identification of biological agents, medicine, and life sciences.
p.000231: (2) Whether the entity is proximate to, and collaborates with, a laboratory that has expertise in the
p.000231: identification of bi- ological agents.
p.000231: (3) Whether the entity demonstrates, in the application for the program, support and participation of State and local
p.000231: gov- ernments and research institutions in the conduct of the pro- gram.
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000231: Sec. 319H PUBLIC HEALTH SERVICE ACT 232
p.000231:
p.000231: (4) Whether the entity is proximate to, and collaborates with, or is, an academic medical center that
p.000231: has the capacity to serve an uninsured or underserved population, and is equipped to educate medical
p.000231: personnel.
p.000231: (5) Such other factors as the Secretary determines to be appropriate.
p.000231: (d) DURATION OF AWARD.—The period during which payments are made under a grant under subsection (a) may
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p.000271: governing board of a public center (as defined in the second sen- tence of this paragraph), establishes general
p.000271: policies for the center; and
p.000271: (iii) in the case of an application for a second or subsequent grant for a public center, has approved the
p.000271: application or if the governing body has not approved the application, the failure of the governing body
p.000271: to approve the application was unreasonable;
p.000271: except that, upon a showing of good cause the Secretary shall waive, for the length of the project period, all
p.000271: or part of the requirements of this subparagraph in the case of a health center that receives a grant
p.000271: pursuant to subsection (g), (h), (i), or (p);
p.000271: (I) the center has developed—
p.000271: (i) an overall plan and budget that meets the re- quirements of the Secretary; and
p.000271: (ii) an effective procedure for compiling and re- porting to the Secretary such statistics and other in-
p.000271: formation as the Secretary may require relating to—
p.000271: (I) the costs of its operations;
p.000271: (II) the patterns of use of its services;
p.000271: (III) the availability, accessibility, and accept- ability of its services; and
p.000271: (IV) such other matters relating to operations of the applicant as the Secretary may require;
p.000271: (J) the center will review periodically its catchment area to—
p.000271: (i) ensure that the size of such area is such that the services to be provided through the center (includ-
p.000271: ing any satellite) are available and accessible to the residents of the area promptly and as appropriate;
p.000271: (ii) ensure that the boundaries of such area con- form, to the extent practicable, to relevant boundaries of
p.000271: political subdivisions, school districts, and Federal and State health and social service programs; and
p.000271: (iii) ensure that the boundaries of such area elimi- nate, to the extent possible, barriers to access to the
p.000271: services of the center, including barriers resulting from the area’s physical characteristics, its
p.000271: residential patterns, its economic and social grouping, and avail- able transportation;
p.000271: (K) in the case of a center which serves a population including a substantial proportion of individuals of
p.000271: limited English-speaking ability, the center has—
p.000271: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000271:
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p.000271: Sec. 330 PUBLIC HEALTH SERVICE ACT 272
p.000271: (i) developed a plan and made arrangements re- sponsive to the needs of such population for providing services
p.000271: to the extent practicable in the language and cultural context most appropriate to such individuals; and
p.000271:
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p.000299: (e) APPLICATION.—An entity that desires a grant under this section shall submit an application to the
p.000299: Secretary at such time, in such manner, and containing such information as the Secretary determines to be
p.000299: reasonable.
p.000299: (f) REPORT.—Not later than 4 years after the date of enactment of the Health Care Safety Net Amendments of 2002, the
p.000299: Secretary shall prepare and submit to the appropriate committees of Con- gress a report that shall
p.000299: evaluate activities funded with grants under this section.
p.000299: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000299: $20,000,000 for fiscal year 2002 and such sums as may be necessary for fiscal years 2003 through 2006.
p.000299: SEC. 330L. ø254c–18¿ TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG STATES.
p.000299: (a) IN GENERAL.—The Secretary may make grants to State pro- fessional licensing boards to carry out programs under
p.000299: which such licensing boards of various States cooperate to develop and imple- ment State policies that
p.000299: will reduce statutory and regulatory bar- riers to telemedicine.
p.000299: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out subsection (a), there are authorized to be
p.000299: appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.
p.000299: SEC. 330M 37 ø254c–19¿ PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
p.000299: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000299: Administration and in coordination with other relevant Federal agencies, shall award grants to States, political
p.000299: subdivisions of States, and Indian tribes and tribal organizations (for purposes of this section, as such terms are
p.000299: defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act (25 U.S.C. 450b)) to
p.000299: promote behavioral health integration in pediatric primary care by—
p.000299: (1) supporting the development of statewide or regional pe- diatric mental health care telehealth access programs; and
p.000299: (2) supporting the improvement of existing statewide or re- gional pediatric mental health care telehealth access
p.000299: programs.
p.000299: (b) PROGRAM REQUIREMENTS.—
p.000299: (1) IN GENERAL.—A pediatric mental health care telehealth access program referred to in subsection (a), with
p.000299: respect to which a grant under such subsection may be used, shall—
p.000299:
p.000299:
p.000299:
p.000299: January 30, 2020
p.000299: 37 So in original. There probably should be a period after ‘‘330M’’.
p.000299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000299:
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p.000299:
p.000299:
p.000301: 301
p.000301: PUBLIC HEALTH SERVICE ACT
p.000301: Sec. 330M
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
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p.000301: (F) conduct training and provide technical assistance to pediatric primary care providers to support the
p.000301: early identification, diagnosis, treatment, and referral of chil- dren with behavioral health conditions;
p.000301: (G) provide information to pediatric providers about, and assist pediatric providers in accessing,
p.000301: pediatric men- tal health care providers, including child and adolescent psychiatrists, and licensed
p.000301: mental health professionals, such as psychologists, social workers, or mental health counselors and in
p.000301: scheduling and conducting technical as- sistance;
p.000301: (H) assist with referrals to specialty care and commu- nity or behavioral health resources; and
p.000301: (I) establish mechanisms for measuring and moni- toring increased access to pediatric mental health
p.000301: care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to
p.000301: identify, treat, and refer children with mental health problems.
p.000301: (2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, the term ‘‘pediatric mental health team’’ means a
p.000301: team con- sisting of at least one case coordinator, at least one child and adolescent psychiatrist, and at
p.000301: least one licensed clinical men- tal health professional, such as a psychologist, social worker, or mental
p.000301: health counselor. Such a team may be regionally based.
p.000301: (c) APPLICATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization seeking a
p.000301: grant under this section shall submit an application to the Secretary at such time, in such manner, and
p.000301: containing such information as the Secretary may re- quire, including a plan for the comprehensive evaluation
p.000301: of activi- ties that are carried out with funds received under such grant.
p.000301: (d) EVALUATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization that
p.000301: receives a grant under this section shall prepare and submit an evaluation of activities that are carried
p.000301: out with funds received under such grant to the Sec- retary at such time, in such manner, and containing such
p.000301: informa-
p.000301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
p.000301:
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p.000301:
p.000301: Sec. 331 PUBLIC HEALTH SERVICE ACT 302
p.000301:
p.000301: tion as the Secretary may reasonably require, including a process and outcome evaluation.
p.000301: (e) ACCESS TO BROADBAND.—In administering grants under this section, the Secretary may coordinate with
p.000301: other agencies to ensure that funding opportunities are available to support access to reliable, high-speed
p.000301: Internet for providers.
p.000301: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section unless the State, political
p.000301: subdivision of a State, Indian tribe, or tribal organization involved agrees, with re- spect to the costs to be
p.000301: incurred by the State, political subdivision of a State, Indian tribe, or tribal organization in carrying out
p.000301: the purpose described in this section, to make available non-Federal contributions (in cash or in kind)
p.000301: toward such costs in an amount that is not less than 20 percent of Federal funds provided in the
p.000301: grant.
p.000301: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated, $9,000,000
p.000301: for the pe- riod of fiscal years 2018 through 2022.
p.000301: Subpart II—National Health Service Corps Program
p.000301: NATIONAL HEALTH SERVICE CORPS
p.000301: SEC. 331. ø254d¿ (a)(1) For the purpose of eliminating health manpower 38 shortages in health professional
p.000301: shortage areas, there is established, within the Service, the National Health Service Corps, which shall
p.000301: consist of—
p.000301: (A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
p.000301: (B) such civilian employees of the United States as the Secretary may appoint, and
p.000301: (C) such other individuals who are not employees of the United States.
p.000301: (2) The Corps shall be utilized by the Secretary to provide pri- mary health services in health professional shortage
p.000301: areas.
p.000301: (3) For purposes of this subpart and subpart III:
p.000301: (A) The term ‘‘Corps’’ means the National Health Service Corps.
p.000301: (B) The term ‘‘Corps member’’ means each of the officers, employees, and individuals of which the Corps
p.000301: consists pursu- ant to paragraph (1).
...

p.000305: (2) The term ‘‘Loan Repayment Program’’ means the Na- tional Health Service Corps Loan Repayment Program
p.000305: estab- lished under section 338B.
p.000305: (3) The term ‘‘Scholarship Program’’ means the National Health Service Corps Scholarship Program
p.000305: established under section 338A.
p.000305: (4) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.000305: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.000305: American Samoa, and the Trust Territory of the Pacific Islands.
p.000305: (5) The terms ‘‘full time’’ and ‘‘full-time’’ mean a minimum of 40 hours per week in a clinical practice, for
p.000305: a minimum of 45 weeks per year.
p.000305: (6) The terms ‘‘half time’’ and ‘‘half-time’’ mean a min- imum of 20 hours per week (not to exceed 39 hours
p.000305: per week) in a clinical practice, for a minimum of 45 weeks per year.
p.000305:
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p.000305: January 30, 2020
p.000305: DESIGNATION OF HEALTH PROFESSIONAL SHORTAGE AREAS
p.000305: SEC. 332. ø254e¿ (a)(1) For purposes of this subpart the term ‘‘health professional shortage area’’ means (A)
p.000305: an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision and
p.000305: which is a rational area for the deliv- ery of health services) which the Secretary determines has a health manpower
p.000305: shortage, (B) a population group which the Secretary de- termines has such a shortage, or (C) a public or
p.000305: nonprofit private medical facility or other public facility which the Secretary deter- mines has such a
p.000305: shortage. All Federally qualified health centers and rural health clinics, as defined in section 1861(aa) of the
p.000305: Social Security Act (42 U.S.C. 1395x(aa)), that meet the requirements of section 334 shall be
p.000305: automatically designated as having such a shortage. The Secretary shall not remove an area from the
p.000305: areas determined to be health professional shortage areas under subpara- graph (A) of the preceding sentence
p.000305: until the Secretary has af- forded interested persons and groups in such area an opportunity to provide
p.000305: data and information in support of the designation as a health professional shortage area or a population group
p.000305: described in subparagraph (B) of such sentence or a facility described in sub- paragraph (C) of such sentence, and has
p.000305: made a determination on the basis of the data and information submitted by such persons and groups and
p.000305: other data and information available to the Sec- retary.
p.000305: (2) For purposes of this subsection, the term ‘‘medical facility’’ means a facility for the delivery of
p.000305: health services and includes—
p.000305: (A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility,
...

p.000311: this paragraph to communicate with other commu- nities, State Offices of Rural Health, State Primary
p.000311: Care Associa- tions and Offices, and other entities concerned with site develop- ment and community needs
p.000311: assessment.
p.000311: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000311:
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p.000311: Sec. 333 PUBLIC HEALTH SERVICE ACT 312
p.000311:
p.000311: (2) The Secretary may provide, to public and private entities which are located in a health professional
p.000311: shortage area to which area a Corps member has been assigned, technical assistance to as- sist in the retention of
p.000311: such member in such area after the comple- tion of such member’s assignment to the area.
p.000311: (3) The Secretary may provide, to health professional shortage areas to which no Corps member has been
p.000311: assigned, (A) technical assistance to assist in the recruitment of health manpower for such areas, and (B) current
p.000311: information on public and private programs which provide assistance in the securing of health manpower.
p.000311: (4)(A) The Secretary shall undertake to demonstrate the im- provements that can be made in the assignment of
p.000311: members of the Corps to health professional shortage areas and in the delivery of health care by Corps
p.000311: members in such areas through coordination with States, political subdivisions of States, agencies of States and
p.000311: political subdivisions, and other public and private entities which have expertise in the planning,
p.000311: development, and operation of cen- ters for the delivery of primary health care. In carrying out this
p.000311: subparagraph, the Secretary shall enter into agreements with qualified entities which provide that if—
p.000311: (i) the entity places in effect a program for the planning, development, and operation of centers for
p.000311: the delivery of pri- mary health care in health professional shortage areas which reasonably addresses the
p.000311: need for such care in such areas, and
p.000311: (ii) under the program the entity will perform the func- tions described in subparagraph (B),
p.000311: the Secretary will assign under this section members of the Corps in accordance with the program.
p.000311: (B) For purposes of subparagraph (A), the term ‘‘qualified enti- ty’’ means a State, political subdivision of a
p.000311: State, an agency of a State or political subdivision, or other public or private entity oper- ating solely within
p.000311: one State, which the Secretary determines is able—
p.000311:
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p.000311: January 30, 2020
p.000311: (i) to analyze the potential use of health professions per-
p.000311: sonnel in defined health services delivery areas by the resi- dents of such areas;
p.000311: (ii) to determine the need for such personnel in such areas and to recruit, select, and retain health
p.000311: professions personnel (including members of the National Health Service Corps) to meet such need;
p.000311: (iii) to determine the extent to which such areas will have a financial base to support the practice of such
p.000311: personnel and the extent to which additional financial resources are needed to adequately support the
p.000311: practice;
p.000311: (iv) to determine the types of inpatient and other health services that should be provided by such
p.000311: personnel in such areas;
p.000311: (v) to assist such personnel in the development of their clinical practice and fee schedules and in the
p.000311: management of their practice;
p.000311: (vi) to assist in the planning and development of facilities for the delivery of primary health care; and
p.000311: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000311:
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p.000441: PUBLIC HEALTH SERVICE ACT
p.000441: Sec. 363
p.000441:
p.000441: applicable only to individuals coming into a State or possession from a foreign country or a possession.
p.000441: (d)(1) Regulations prescribed under this section may provide for the apprehension and examination of any
p.000441: individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be
p.000441: moving or about to move from a State to an- other State; or (B) to be a probable source of infection
p.000441: to individ- uals who, while infected with such disease in a qualifying stage, will be moving from a State
p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
p.000441: SEC. 363. 73 ø266¿ To protect the military and naval forces and war workers of the United States, in time of war,
p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
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p.000469: $30,000,000 for each of fiscal years 2016 through 2020.
p.000469: PART J—PREVENTION AND CONTROL OF INJURIES
p.000469: RESEARCH
p.000469: SEC. 391. ø280b¿ (a) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall—
p.000469: (1) conduct, and give assistance to public and nonprofit private entities, scientific institutions, and
p.000469: individuals engaged in the conduct of, research relating to the causes, mechanisms, prevention, diagnosis, treatment
p.000469: 87 of injuries, and rehabilita- tion from injuries;
p.000469: (2) make grants to, or enter into cooperative agreements or contracts with, public and nonprofit private entities
p.000469: (including academic institutions, hospitals, and laboratories) and individ- uals for the conduct of such research; and
p.000469: (3) make grants to, or enter into cooperative agreements or contracts with, academic institutions for the purpose
p.000469: of pro- viding training on the causes, mechanisms, prevention, diag- nosis, treatment of injuries, and
p.000469: rehabilitation from injuries.
p.000469: (b) The Secretary, through the Director of the Centers for Dis- ease Control and Prevention, shall collect and
p.000469: disseminate, through publications and other appropriate means, information concerning the practical
p.000469: applications of research conducted or assisted under subsection (a). In carrying out the preceding
p.000469: sentence, the Sec- retary shall disseminate such information to the public, including through elementary and
p.000469: secondary schools.
p.000469: PREVENTION AND CONTROL ACTIVITIES
p.000469: SEC. 392. ø280b–0¿ (a) The Secretary, through the Director of the Centers for Disease Control and Prevention,
p.000469: shall—
p.000469: (1) assist States and political subdivisions of States in ac- tivities for the prevention and control of
p.000469: injuries; and
p.000469:
p.000469:
p.000469:
p.000469: January 30, 2020
p.000469: 87 So in law. Probably should read ‘‘...diagnosis, and treatment...’’.
p.000469: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000469:
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p.000469:
p.000469: Sec. 392A PUBLIC HEALTH SERVICE ACT 470
p.000469:
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p.000469: January 30, 2020
p.000469:
p.000469: (2) encourage regional activities between States designed to reduce injury rates.
p.000469: (b) The Secretary, through the Director of the Centers for Dis- ease Control and Prevention, may—
p.000469: (1) enter into agreements between the Service and public and private community health agencies which provide
p.000469: for coop- erative planning of activities to deal with problems relating to the prevention and control of injuries;
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p.000481: (3) otherwise be in such form, be made in such manner, and contain such information and agreements as the
p.000481: Secretary determines to be necessary to carry out this subpart.
p.000481: (d) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary shall—
p.000481: (1) provide for an evaluation of each demonstration project for which a grant is made under section 395(a); and
p.000481: (2) not later than 6 months after the completion of such evaluations, submit to the Congress a report
p.000481: describing the findings made as a result of the evaluations.
p.000481: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000481: to be appropriated
p.000481: $5,000,000 for each of the fiscal years 1988 through 1990,
p.000481: $7,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
p.000481:
p.000481: Subpart II—Programs With Respect to Alzheimer’s Disease and Related Dementias
p.000481:
p.000481:
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p.000481: January 30, 2020
p.000481: SEC. 398. ø280c–3¿ COOPERATIVE AGREEMENTS TO STATES AND PUB- LIC HEALTH DEPARTMENTS FOR ALZHEIMER’S
p.000481: DISEASE AND RELATED DEMENTIAS.
p.000481: (a) IN GENERAL.—The Secretary, in coordination with the Di- rector of the Centers for Disease Control
p.000481: and Prevention and the heads of other agencies, as appropriate, shall award cooperative agreements to
p.000481: health departments of States, political subdivisions of States, and Indian tribes and tribal organizations,
p.000481: to address Alzheimer’s disease and related dementias, including by reducing cognitive decline, helping meet
p.000481: the needs of caregivers, and ad- dressing unique aspects of Alzheimer’s disease and related demen- tias to
p.000481: support the development and implementation of evidence- based interventions with respect to—
p.000481: (1) educating and informing the public, based on evidence- based public health research and data, about
p.000481: Alzheimer’s dis- ease and related dementias;
p.000481: (2) supporting early detection and diagnosis;
p.000481: (3) reducing the risk of potentially avoidable hospitaliza- tions for individuals with Alzheimer’s disease
p.000481: and related de- mentias;
p.000481: (4) reducing the risk of cognitive decline and cognitive im- pairment associated with Alzheimer’s disease and
p.000481: related de- mentias;
p.000481: (5) improving support to meet the needs of caregivers of in- dividuals with Alzheimer’s disease and related dementias;
p.000481: (6) supporting care planning and management for individ- uals with Alzheimer’s disease and related dementias.
p.000481: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000481:
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p.000483: 483
p.000483: PUBLIC HEALTH SERVICE ACT
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p.000483: in such manner, and containing such information as the Secretary may require, including a plan that describes—
p.000483: (1) how the applicant proposes to develop or expand, pro- grams to educate individuals through partnership
p.000483: engagement, workforce development, guidance and support for pro- grammatic efforts, and evaluation
p.000483: with respect to Alzheimer’s disease and related dementias, and in the case of a cooperative agreement under this
p.000483: section, how the applicant proposes to support other relevant activities identified by the Secretary or Director
p.000483: of the Centers for Disease Control and Prevention, as appropriate.
p.000483: (2) the manner in which the applicant will coordinate with Federal, tribal, and State programs related to Alzheimer’s
p.000483: dis- ease and related dementias, and appropriate State, tribal, and local agencies, as well as other relevant public
p.000483: and private or- ganizations or agencies; and
p.000483: (3) the manner in which the applicant will evaluate the ef- fectiveness of any program carried out under the
p.000483: cooperative agreement.
p.000483: (d) MATCHING REQUIREMENT.—Each health department that is awarded a cooperative agreement under subsection (a)
p.000483: shall pro- vide, from non-Federal sources, an amount equal to 30 percent of the amount provided under
p.000483: such agreement (which may be pro- vided in cash or in-kind) to carry out the activities supported by
p.000483: the cooperative agreement.
p.000483: (e) WAIVER AUTHORITY.—The Secretary may waive all or part of the matching requirement described in
p.000483: subsection (d) for any fis- cal year for a health department of a State, political subdivision of a State, or Indian
p.000483: tribe and tribal organization (including those lo- cated in a rural area or frontier area), if the Secretary determines
p.000483: that applying such matching requirement would result in serious hardship or an inability to carry out
p.000483: the purposes of the coopera- tive agreement awarded to such health department of a State, po- litical
p.000483: subdivision of a State, or Indian tribe and tribal organiza- tion.
p.000483: (g) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a
p.000483: grant 92 under subsection (a) for any item or service to the extent that payment
p.000483:
p.000483:
p.000483:
p.000483:
p.000483: January 30, 2020
p.000483: 92 Section 3(6) of Public Law 115–406 provides as follows: ‘‘(6) in subsection (f) (as so redesig- nated), by striking
p.000483: ‘grant’ and inserting ‘cooperative agreement’ ’’. The amendment was not car- ried out because it probably should have
p.000483: been made to subsection (g) (as so redesignated).
p.000483: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000483:
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p.000483: Sec. 398A PUBLIC HEALTH SERVICE ACT 484
p.000483:
p.000483: has been made, or can reasonably be expected to be made, with re- spect to such item or service—
p.000483: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000483: health benefits program; or
...

p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
p.000525: or high rate of hos- pitalization or emergency room visits for asthma (relative to the average
p.000525: asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate
p.000525: a high prevalence of childhood asthma or high asthma-related mortality may include data from Fed- eral, State, or
p.000525: local vital statistics, claims data under title XIX or XXI of the Social Security Act, other public health
p.000525: statistics or surveys, or other data that the Secretary, in consultation with the Director of the
p.000525: Centers for Disease Control and Prevention, deems appropriate.
p.000525: (3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a
p.000525: public or nonprofit private entity (including a State or political subdivision of a State), or a consortium
p.000525: of any of such entities.
p.000525: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—An el- igible entity shall identify in the plan submitted
p.000525: as part of an ap- plication for a grant under this section how the entity will coordi- nate operations
p.000525: and activities under the grant with—
p.000525:
p.000525:
p.000525:
p.000525:
p.000525: January 30, 2020
p.000525: 103 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and paragraph
p.000525: (3) probably should be redesignated as paragraphs (3) and (4), respectively. See sec- tion 501 of Public Law 106–310
p.000525: (114 Stat. 1113).
p.000525: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000525:
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p.000525: Sec. 399L PUBLIC HEALTH SERVICE ACT 526
p.000525:
p.000525: (1) other programs operated in the State that serve chil- dren with asthma, including any such
p.000525: programs operated under title V, XIX, or XXI of the Social Security Act; and
p.000525: (2) one or more of the following—
p.000525: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000525: such Act;
p.000525: (B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);
...

p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
p.000551: (2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ means—
p.000551: (A) a State or a political subdivision of a State;
p.000551: (B) a consortium of 2 or more States or political sub- divisions of States;
p.000551: (C) a territory;
p.000551: (D) a health facility or program operated by or pursu- ant to a contract with or grant from the Indian Health
p.000551: Service; or
p.000551: (E) any other entity with appropriate expertise in pre- natally and postnatally diagnosed conditions (including na-
p.000551: tionally recognized disability groups), as determined by the Secretary.
p.000551: (3) DISTRIBUTION.—In distributing funds under this sub- section, the Secretary shall place an emphasis on funding
p.000551: part- nerships between health care professional groups and dis- ability advocacy organizations.
p.000551:
p.000551:
p.000551:
p.000551: January 30, 2020
p.000551: 107 So in law. Probably should read ‘‘section 2(1)’’.
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000569: existing programs, such as the Epi-Aids program of the Centers for Dis- ease Control and Prevention and the Assessments
p.000569: of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry.
p.000569:
p.000569:
p.000569:
p.000569:
p.000569: January 30, 2020 As Amended Through P.L. 116-94,
p.000569: Enacted December 20, 2019
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p.000569:
p.000569: Sec. 399W PUBLIC HEALTH SERVICE ACT
p.000569:
p.000569: PART Q—PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
p.000570: 570
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p.000570: January 30, 2020
p.000570: SEC. 399W. ø280h¿ GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL ACTIVITY.
p.000570: (a) IN GENERAL.—The Secretary, acting though the Director of the Centers for Disease Control and Prevention,
p.000570: shall award com- petitive grants to States and political subdivisions of States for the development and
p.000570: implementation of State and community-based intervention programs to promote good nutrition and physical
p.000570: ac- tivity in children and adolescents.
p.000570: (b) ELIGIBILITY.—To be eligible to receive a grant under this section a State or political subdivision of a
p.000570: State shall prepare and submit to the Secretary an application at such time, in such man- ner, and containing such
p.000570: information as the Secretary may require, including a plan that describes—
p.000570: (1) how the applicant proposes to develop a comprehensive program of school- and community-based approaches to encour-
p.000570: age and promote good nutrition and appropriate levels of phys- ical activity with respect to children or
p.000570: adolescents in local communities;
p.000570: (2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as
p.000570: State and local school departments, State departments of health, chronic disease directors, State directors of programs
p.000570: under section 17 of the Child Nutrition Act of 1966, 5-a-day coordinators, gov- ernors councils for
p.000570: physical activity and good nutrition, and State and local parks and recreation departments; and
p.000570: (3) the manner in which the applicant will evaluate the ef- fectiveness of the program carried out under this section.
p.000570: (c) USE OF FUNDS.—A State or political subdivision of a State shall use amount received under a grant under
p.000570: this section to—
p.000570: (1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to
p.000570: reduce inactivity and improve dietary choices among children and adolescents;
p.000570: (2) expand opportunities for physical activity programs in school- and community-based settings; and
p.000570: (3) develop, implement, and evaluate programs that pro- mote good eating habits and physical activity including
p.000570: oppor- tunities for children with cognitive and physical disabilities.
p.000570: (d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an amount not to exceed 10 percent of the amount
p.000570: appropriated for a fiscal year under subsection (h) to permit the Director of the Cen- ters for Disease
p.000570: Control and Prevention to—
p.000570: (1) provide States and political subdivisions of States with technical support in the development and
p.000570: implementation of programs under this section; and
p.000570: (2) disseminate information about effective strategies and interventions in preventing and treating obesity
p.000570: through the promotion of good nutrition and physical activity.
p.000570: (e) LIMITATION ON ADMINISTRATIVE COSTS.—Not to exceed 10 percent of the amount of a grant awarded to
p.000570: the State or political subdivision under subsection (a) for a fiscal year may be used by the State or
p.000570: political subdivision for administrative expenses.
p.000570: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000570:
p.000570:
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p.000571: 571
p.000571: PUBLIC HEALTH SERVICE ACT
p.000571: Sec. 399Y
p.000571:
p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
...

p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
p.000577: State epidemiological data for children and adults with autism spectrum disorder and other developmental
p.000577: disabilities. An eligible entity shall assist with the development and coordination of State autism
p.000577: spectrum disorder and other developmental disability surveil- lance efforts within a region. In making such
p.000577: awards, the Sec- retary may provide direct technical assistance in lieu of cash.
p.000577: (2) DATA STANDARDS.—In submitting epidemiological data to the Secretary pursuant to paragraph (1), an
p.000577: eligible entity shall report data according to guidelines prescribed by the Di- rector of the Centers for Disease
p.000577: Control and Prevention, after consultation with relevant State, local, and Tribal public health
p.000577: officials, private sector developmental disability re- searchers, and advocates for individuals with autism
p.000577: spectrum disorder and other developmental disabilities.
p.000577: (3) ELIGIBILITY.—To be eligible to receive an award under paragraph (1), an entity shall be a public or
p.000577: nonprofit private entity (including a health department of a State or a political subdivision of a
p.000577: State, a university, any other educational in- stitution, an Indian tribe, or a tribal organization), and submit
p.000577: to the Secretary an application at such time, in such manner, and containing such information as the
p.000577: Secretary may require.
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000577:
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p.000577: Sec. 399AA PUBLIC HEALTH SERVICE ACT 578
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p.000577: January 30, 2020
p.000577:
p.000577: (b) CENTERS OF EXCELLENCE IN AUTISM SPECTRUM DISORDER EPIDEMIOLOGY.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: shall, subject to the availability of appropriations, award grants or cooperative agreements for the
...

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p.000827: January 30, 2020
p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
...

p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000855:
p.000855: mination and Education Assistance Act) to focus on emerging trends in substance abuse and co-occurrence
p.000855: of substance use disorders with mental illness or other conditions.
p.000855: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000855: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000855: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000855: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000855: public or nonprofit private entities.
p.000855: (b) PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS.—
p.000855: (1) IN GENERAL.—Priority substance use disorder treat- ment needs of regional and national significance shall be
p.000855: deter- mined by the Secretary after consultation with States and other interested groups. The Secretary
p.000855: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000855: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000855: con- sideration to promoting the integration of substance use dis- order treatment services into primary health
p.000855: care systems.
p.000855: (c) REQUIREMENTS.—
p.000855: (1) IN GENERAL.—Recipients of grants, contracts, or cooper- ative agreements under this section shall comply with
p.000855: informa- tion and application requirements determined appropriate by the Secretary.
p.000855: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
...

p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: 861
p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: January 30, 2020
p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
...

p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: Sec. 516 PUBLIC HEALTH SERVICE ACT 862
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p.000861:
p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
p.000861: (B) promoting the integration of substance use dis- order prevention information and activities into
p.000861: primary health care systems; and
p.000861: (C) substance use disorder prevention among high-risk groups.
p.000861: (c) REQUIREMENTS.—
...

p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
p.000875: (11) conduct services-related assessments, including eval- uations of the organization and financing of care,
p.000875: self-help and consumer-run programs, mental health economics, mental health service systems, rural mental
p.000875: health and tele-mental health, and improve the capacity of State to conduct evalua- tions of publicly
p.000875: funded mental health programs;
p.000875: (12) disseminate mental health information, including evi- dence-based practices, to States, political
p.000875: subdivisions, edu- cational agencies and institutions, treatment and prevention service providers, and the
p.000875: general public, including information concerning the practical application of research supported by the
p.000875: National Institute of Mental Health that is applicable to improving the delivery of services;
p.000875: (13) provide technical assistance to public and private enti- ties that are providers of mental health services;
p.000875: (14) monitor and enforce obligations incurred by commu- nity mental health centers pursuant to the Community
p.000875: Mental Health Centers Act (as in effect prior to the repeal of such Act on August 13, 1981, by section
p.000875: 902(e)(2)(B) of Public Law 97– 35 (95 Stat. 560));
p.000875: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000875: Sec. 520A PUBLIC HEALTH SERVICE ACT 876
p.000875:
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p.000875: January 30, 2020
p.000875:
p.000875: (15) conduct surveys with respect to mental health, such as the National Reporting Program;
p.000875: (16) assist States in improving their mental health data collection; and
p.000875: (17) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000875: of grantees after such grants are awarded.
p.000875: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000875: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000875: SEC. 520A. ø290bb–32¿ PRIORITY MENTAL HEALTH NEEDS OF RE- GIONAL AND NATIONAL SIGNIFICANCE.
p.000875: (a) PROJECTS.—The Secretary shall address priority mental health needs of regional and national
p.000875: significance (as determined under subsection (b)) through the provision of or through assist- ance for—
p.000875: (1) knowledge development and application projects for prevention, treatment, and rehabilitation, and the
p.000875: conduct or support of evaluations of such projects;
p.000875: (2) training and technical assistance programs;
p.000875: (3) targeted capacity response programs; and
p.000875: (4) systems change grants including statewide family net- work grants and client-oriented and consumer run
p.000875: self-help ac- tivities, which may include technical assistance centers.
p.000875: The Secretary may carry out the activities described in this sub- section directly or through grants,
p.000875: contracts, or cooperative agree- ments with States, political subdivisions of States, Indian tribes or tribal
p.000875: organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education
p.000875: Assistance Act), health facilities, or programs operated by or in accordance with a contract or grant with the Indian
p.000875: Health Service, or, other public or private nonprofit entities.
p.000875: (b) PRIORITY MENTAL HEALTH NEEDS.—
p.000875: (1) DETERMINATION OF NEEDS.—Priority mental health needs of regional and national significance shall be
p.000875: determined by the Secretary in consultation with States and other inter- ested groups. The Secretary shall
p.000875: meet with the States and in- terested groups on an annual basis to discuss program prior- ities.
p.000875: (2) SPECIAL CONSIDERATION.—In developing program prior- ities described in paragraph (1), the Secretary shall
p.000875: give spe- cial consideration to promoting the integration of mental health services into primary health
p.000875: care systems.
p.000875: (c) REQUIREMENTS.—
p.000875: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000875: infor- mation and application requirements determined appropriate by the Secretary.
p.000875: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000875: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000875: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000875:
p.000875:
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p.000877: $394,550,000 for each of fiscal years 2018 through 2022.
p.000877: øSection 520B was repealed by section 9017 of Public Law 114–255.¿
p.000877:
p.000877: January 30, 2020 As Amended Through P.L. 116-94,
p.000877: Enacted December 20, 2019
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p.000877: Sec. 520C PUBLIC HEALTH SERVICE ACT 878
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p.000877: January 30, 2020
p.000877:
p.000877: SEC. 520C. ø290bb–34¿ SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.
p.000877: (a) PROGRAM AUTHORIZED.—The Secretary, acting through the Assistant Secretary, shall establish a research,
p.000877: training, and tech- nical assistance resource center to provide appropriate information, training, and technical
p.000877: assistance to States, political subdivisions of States, federally recognized Indian tribes, tribal organizations,
p.000877: in- stitutions of higher education, public organizations, or private non- profit organizations regarding the
p.000877: prevention of suicide among all ages, particularly among groups that are at a high risk for suicide.
p.000877: (b) RESPONSIBILITIES OF THE CENTER.—The center established under subsection (a) shall conduct activities for
p.000877: the purpose of—
p.000877: (1) developing and continuing statewide or tribal suicide early intervention and prevention strategies for
p.000877: all ages, par- ticularly among groups that are at a high risk for suicide;
p.000877: (2) ensuring the surveillance of suicide early intervention and prevention strategies for all ages,
p.000877: particularly among groups that are at a high risk for suicide;
p.000877: (3) studying the costs and effectiveness of statewide and tribalsuicide early intervention and prevention
p.000877: strategies in order to provide information concerning relevant issues of im- portance to State, tribal, and
p.000877: national policymakers;
p.000877: (4) further identifying and understanding causes and asso- ciated risk factors for suicide;
p.000877: (5) analyzing the efficacy of new and existing suicide early intervention and prevention techniques and technology;
p.000877: (6) ensuring the surveillance of suicidal behaviors and nonfatal suicidal attempts;
...

p.000879: suicide early intervention and pre- vention strategy.
p.000879: (2) LIMITATION.—In carrying out this section, the Secretary shall ensure that a State does not receive more
p.000879: than 1 grant or cooperative agreement under this section at any 1 time. For purposes of the preceding sentence, a
p.000879: State shall be considered to have received a grant or cooperative agreement if the eligi- ble entity
p.000879: involved is the State or an entity designated by the State under paragraph (1)(B). Nothing in this paragraph
p.000879: shall be construed to apply to entities described in paragraph (1)(C).
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: Sec. 520E PUBLIC HEALTH SERVICE ACT 880
p.000879: (3) CONSIDERATION.—In awarding grants under this sec- tion, the Secretary shall take into consideration
p.000879: the extent of the need of the applicant, including the incidence and preva- lence of suicide in the
p.000879: State and among the populations of focus, including rates of suicide determined by the Centers for Disease
p.000879: Control and Prevention for the State or population of focus.
p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: January 30, 2020
p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
...

p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
p.000883: private nonprofit organizations, political subdivisions, consortia of political subdivi- sions, consortia of
p.000883: States, or Federally recognized Indian tribes or tribal organizations to design early intervention and
p.000883: prevention strategies that will complement the State-sponsored statewide or tribal youth suicide early
p.000883: intervention and prevention strategies developed pursuant to section 520E.
p.000883: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall ensure that activities under this
p.000883: section are coordi- nated with the relevant Department of Health and Human Services agencies and suicide working
p.000883: groups.
p.000883: (c) REQUIREMENTS.—A public organization, private nonprofit organization, political subdivision, consortium of
p.000883: political subdivi- sions, consortium of States, or federally recognized Indian tribe or tribal organization
p.000883: desiring a grant, contract, or cooperative agree- ment under this section shall demonstrate that the suicide preven-
p.000883: tion program such entity proposes will—
p.000883:
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p.000883: January 30, 2020
p.000883: 10 The probable intent of the Congress is that the heading be ‘‘SUICIDE PREVENTION FOR YOUTH’’. See the amendment
p.000883: described in section 3(b)(1)(A) of Public Law 108–355 (118 Stat. 1407). The amendment cannot be executed
p.000883: because the matter in the heading to be struck does not appear, as the amendatory instruction used the wrong
p.000883: font. The amendment referred to ‘‘CHILDREN AND ADOLESCENTS’’ rather than ‘‘CHILDREN AND ADOLESCENTS’’. (The
p.000883: amendment is directed to section ‘‘520E’’. Section 520E–1 above formerly was section 520E, and was redesignated by
p.000883: section 3(b)(2) of such Public Law.)
p.000883: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000883:
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p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
p.000883:
p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
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p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
p.000883: (e) CONDITION.—An applicant for a grant or cooperative agree- ment under subsection (a) shall demonstrate to the
p.000883: Secretary that the application complies with the State-sponsored statewide early intervention and prevention
p.000883: strategy as developed under section 520E and the applicant has the support of the local community and relevant
p.000883: public health officials.
p.000883: (f) SPECIAL POPULATIONS.—In awarding grants and cooperative agreements under subsection (a), the Secretary shall
p.000883: ensure that such awards are made in a manner that will focus on the needs of communities or groups
p.000883: that experience high or rapidly rising rates of suicide.
p.000883:
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p.000883: January 30, 2020
p.000883: 11 So in law. Probably should include ‘‘and’’ after the semicolon at the end of paragraph (9). See
p.000883: section 3(b)(1)(D)(ix) of Public Law 108–355 (118 Stat. 1408).
p.000883: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885: PUBLIC HEALTH SERVICE ACT
p.000885: Sec. 520E–1
p.000885:
p.000885: (g) APPLICATION.—A public organization, private nonprofit or- ganization, political subdivision, consortium
p.000885: of political subdivi- sions, consortium of States, or Federally recognized Indian tribe or tribal organization
p.000885: receiving a grant or cooperative agreement under subsection (a) shall prepare and submit an application to
p.000885: the Secretary at such time, in such manner, and containing such infor- mation as the Secretary may reasonably
p.000885: require. Such application shall include a plan for the rigorous evaluation of activities funded under the grant or
p.000885: cooperative agreement, including a process and outcome evaluation.
p.000885: (h) DISTRIBUTION OF AWARDS.—In awarding grants and cooper- ative agreements under subsection (a), the Secretary
p.000885: shall ensure that such awards are distributed among the geographical regions of the United States and between
p.000885: urban and rural settings.
p.000885: (i) EVALUATION.—A public organization, private nonprofit orga- nization, political subdivision, consortium of
p.000885: political subdivisions, consortium of States, or Federally recognized Indian tribe or tribal organization receiving a
p.000885: grant or cooperative agreement under sub- section (a) shall prepare and submit to the Secretary at the end of the
p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
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p.000889: evaluation of the effect of such grant on—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: 891
p.000891: PUBLIC HEALTH SERVICE ACT
p.000891: Sec. 520G
p.000891:
p.000891: (1) local crisis response services and measures for individ- uals receiving crisis planning and early
p.000891: intervention supports;
p.000891: (2) individuals reporting improved functional outcomes;
p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000891:
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
p.000891: (2) create or expand community-based mental health and co-occurring mental illness and substance use disorder
p.000891: services to accommodate the diversion program;
p.000891: (3) train professionals involved in the system of care, and law enforcement officers, attorneys, and judges;
p.000891: (4) provide community outreach and crisis intervention;
p.000891: and
p.000891: (5) develop programs to divert individuals prior to booking
p.000891:
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p.000891: January 30, 2020
p.000891: or arrest.
p.000891: (f) FEDERAL SHARE.—
p.000891: (1) IN GENERAL.—The Secretary shall pay to a State, polit- ical subdivision of a State, Indian tribe, or tribal
p.000891: organization receiving a grant under subsection (a) the Federal share of the cost of activities described in the
p.000891: application.
p.000891: (2) FEDERAL SHARE.—The Federal share of a grant made under this section shall not exceed 75 percent of the
p.000891: total cost of the program carried out by the State, political subdivision of a State, Indian tribe, or tribal
p.000891: organization. Such share shall be used for new expenses of the program carried out by such State, political
p.000891: subdivision of a State, Indian tribe, or tribal or- ganization.
p.000891: (3) NON-FEDERAL SHARE.—The non-Federal share of pay- ments made under this section may be made in cash or in kind
p.000891: fairly evaluated, including planned equipment or services. The Secretary may waive the requirement of matching
p.000891: contribu- tions.
p.000891: (g) GEOGRAPHIC DISTRIBUTION.—The Secretary shall ensure that such grants awarded under subsection (a) are
p.000891: equitably dis-
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: 893
p.000893: PUBLIC HEALTH SERVICE ACT
p.000893: Sec. 520I
p.000893:
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p.000893: January 30, 2020
p.000893: tributed among the geographical regions of the United States and between urban and rural populations.
p.000893: (h) TRAINING AND TECHNICAL ASSISTANCE.—Training and tech- nical assistance may be provided by the Secretary to
p.000893: assist a State, political subdivision of a State, Indian tribe, or tribal organization receiving a grant under
p.000893: subsection (a) in establishing and operating a diversion program.
p.000893: (i) EVALUATIONS.—The programs described in subsection (a) shall be evaluated not less than one time in every
p.000893: 12-month period using the methodology and outcome measures identified in the grant application.
p.000893: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000893: $4,269,000 for each of fiscal years 2018 through 2022.
p.000893: øSection 520H was repealed by section 9017 of Public Law 114–255.¿
p.000893: SEC. 520I. ø290bb–40¿ GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS MENTAL ILLNESS AND CO-OCCURRING
p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: Sec. 520J PUBLIC HEALTH SERVICE ACT 894
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p.000893: January 30, 2020
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p.000893: previously provided only mental health services or only sub- stance abuse services; and
p.000893: (6) to provide services in coordination with other existing public and private community programs.
p.000893: (d) CONDITION.—The Secretary shall ensure that a State, polit- ical subdivision of a State, Indian tribe, tribal
p.000893: organization, or pri- vate nonprofit organization that receives a grant, contract, or coop- erative agreement under
p.000893: subsection (a) maintains the level of effort necessary to sustain existing mental health and substance abuse
p.000893: programs for other populations served by mental health systems in the community.
p.000893: (e) DISTRIBUTION OF AWARDS.—The Secretary shall ensure that grants, contracts, or cooperative agreements awarded
p.000893: under sub- section (a) are equitably distributed among the geographical re- gions of the United States
p.000893: and between urban and rural popu- lations.
p.000893: (f) DURATION.—The Secretary shall award grants, contract, or cooperative agreements under this subsection
p.000893: for a period of not more than 5 years.
p.000893: (g) APPLICATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or
p.000893: private nonprofit organization that desires a grant, contract, or cooperative agreement under this subsection shall
p.000893: prepare and submit an application to the Secretary at such time, in such manner, and containing such
p.000893: information as the Secretary may require. Such application shall include a plan for the rigorous
p.000893: evaluation of activities funded with an award under such subsection, including a process and outcomes
p.000893: evalua- tion.
p.000893: (h) EVALUATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
p.000893: (i) AUTHORIZATION OF APPROPRIATION.—There is authorized to be appropriated to carry out this subsection
p.000893: $40,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 through 2003.
p.000893: SEC. 520J. ø290bb–41¿ MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.000893: (a) IN GENERAL.—The Secretary shall award grants in accord- ance with the provisions of this section.
p.000893: (b) MENTAL HEALTH AWARENESS TRAINING GRANTS.—
p.000893: (1) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian tribes,
p.000893: tribal or- ganizations, and nonprofit private entities to train teachers and other relevant school personnel
p.000893: to recognize symptoms of childhood and adolescent mental disorders, to refer family members to the
p.000893: appropriate mental health services if nec- essary, to train emergency services personnel veterans, law en-
p.000893: forcement, and other categories of individuals, as determined by the Secretary, to identify and appropriately
p.000893: respond to per- sons with a mental illness, and to provide education to such
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: 895
p.000895: PUBLIC HEALTH SERVICE ACT
p.000895: Sec. 520K
p.000895:
p.000895: teachers and personnel regarding resources that are available in the community for individuals with a mental
p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
p.000895: (4) APPLICATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that desires a grant under this subsection shall submit an ap- plication to the Secretary at such
p.000895: time, in such manner, and containing such information as the Secretary may require, in- cluding a plan for
p.000895: the rigorous evaluation of activities that are carried out with funds received under a grant under this sub-
p.000895: section.
p.000895: (5) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private en- tity receiving a grant under this subsection shall use funds from such grant for
p.000895: evidence-based programs that provide training and education in accordance with paragraph (1) on matters
p.000895: including—
p.000895: (A) recognizing the signs and symptoms of mental ill- ness; and
p.000895: (B)(i) resources available in the community for individ- uals with a mental illness and other relevant resources; or
p.000895: (ii) safely de-escalating crisis situations involving indi- viduals with a mental illness.
p.000895: (6) EVALUATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that receives a grant under this subsection shall prepare and submit an evaluation to the
p.000895: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require,
p.000895: including an evaluation of activities carried out with funds received under the grant under this subsection and a
p.000895: process and outcome evaluation.
p.000895: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this
p.000895: subsection$14,693,000 for each of fiscal years 2018 through 2022.
p.000895: SEC. 520K. ø290bb–42¿ INTEGRATION INCENTIVE GRANTS AND COOP- ERATIVE AGREEMENTS.
p.000895: (a) DEFINITIONS.—In this section:
p.000895: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, or other appropriate State agency, in
p.000895: collaboration with 1 or more qualified community programs as described in sec- tion 1913(b)(1) or 1 or
p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
p.000895: and physical
p.000895:
p.000895:
p.000895:
p.000895:
p.000895: January 30, 2020
p.000895: 13 So in law. Words in the heading (except the first) probably should be all small caps. See section
p.000895: 3213 of Public Law 106–310 (114 Stat. 1206).
p.000895: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000895:
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p.000897: ical health conditions and chronic diseases, attendance at scheduled medical and mental health
p.000897: appointments, com- pliance with prescribed medication regimes, and participa- tion in learning opportunities at school
p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
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p.000897: Sec. 520L PUBLIC HEALTH SERVICE ACT 898
p.000897:
p.000897: els;
p.000897: (A) development and selection of integrated care mod-
p.000897: (B) dissemination of evidence-based interventions in
p.000897: integrated care;
p.000897: (C) establishment of organizational practices to sup- port operational and administrative success; and
p.000897: (D) other activities, as the Secretary determines ap- propriate.
p.000897: (2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA- TION.—The information and resources provided by the
p.000897: Sec- retary under paragraph (1) shall, as appropriate, be made available to States, political
p.000897: subdivisions of States, Indian tribes or tribal organizations (as defined in section 4 of the In- dian
p.000897: Self-Determination and Education Assistance Act), out- patient mental health and addiction treatment
p.000897: centers, com- munity mental health centers that meet the criteria under sec- tion 1913(c), certified community
p.000897: behavioral health clinics de- scribed in section 223 of the Protecting Access to Medicare Act of 2014, primary care
p.000897: organizations such as Federally qualified health centers or rural health clinics as defined in section
p.000897: 1861(aa) of the Social Security Act, other community-based or- ganizations, or other entities engaging in
p.000897: integrated care ac- tivities, as the Secretary determines appropriate.
p.000897: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
p.000897: tion, there are authorized to be appropriated $51,878,000 for each of fiscal years 2018 through 2022.
p.000897: SEC. 520L. ø290bb–43¿ ADULT SUICIDE PREVENTION.
p.000897: (a) GRANTS.—
p.000897: (1) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities described in
p.000897: paragraph (2) to imple- ment suicide prevention and intervention programs, for indi- viduals who are 25
p.000897: years of age or older, that are designed to raise awareness of suicide, establish referral processes, and im-
p.000897: prove care and outcomes for such individuals who are at risk of suicide.
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p.000899: January 30, 2020
p.000899: (B) Implementing evidence-based practices to provide treatment for individuals at risk for suicide,
p.000899: including ap- propriate followup services.
p.000899: (C) Raising awareness and reducing stigma of suicide.
p.000899: (b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant Secretary shall—
p.000899: (1) evaluate the activities supported by grants awarded under subsection (a), and disseminate, as appropriate,
p.000899: the find- ings from the evaluation; and
p.000899: (2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities
p.000899: that receive a grant under this section, in order to help such entities to meet the requirements of this section,
p.000899: including assistance with se- lection and implementation of evidence-based interventions and frameworks
p.000899: to prevent suicide.
p.000899: (c) DURATION.—A grant under this section shall be for a period of not more than 5 years.
p.000899: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $30,000,000
p.000899: for the pe- riod of fiscal years 2018 through 2022.
p.000899: SEC. 520M. ø290bb–44¿ ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
p.000899: (D) patient and family satisfaction with program par- ticipation; and
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p.000899: recipients to establish, maintain, or expand their assertive community treatment programs.
p.000899: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.000899: (1) IN GENERAL.—To carry out this section, there is author- ized to be appropriated $5,000,000 for the period of fiscal
p.000899: years 2018 through 2022.
p.000899: (2) USE OF CERTAIN FUNDS.—Of the funds appropriated to carry out this section in any fiscal year, not
p.000899: more than 5 per- cent shall be available to the Assistant Secretary for carrying out subsection (d).
p.000899: PART C—PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS
p.000899: SEC. 521. ø290cc–21¿ FORMULA GRANTS TO STATES.
p.000899: For the purpose of carrying out section 522, the Secretary, act- ing through the Director of the Center for Mental
p.000899: Health Services, shall for each of the fiscal years 2018 through 2022 make an allot- ment for each State in an
p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
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p.000929: (3) the retention rate of program participants; and
p.000929: (4) any other information that the Secretary may require for the purpose of—ensuring that the Center is
p.000929: complying with all the requirements of the grant, including providing the full continuum of services described
p.000929: in subsection (g)(1)(B).
p.000929: (i) PRIVACY.—The provisions of this section, including with re- spect to data reporting and program
p.000929: oversight, shall be subject to all applicable Federal and State privacy laws.
p.000929: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $10,000,000 for each of fiscal
p.000929: years 2019 through 2023 for purposes of carrying out this section.
p.000929: PART E—CHILDREN WITH SERIOUS EMOTIONAL DISTURBANCES
p.000929: SEC. 561. ø290ff¿ COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CHILDREN WITH SERIOUS
p.000929: EMOTIONAL DISTURBANCES.
p.000929: (a) GRANTS TO CERTAIN PUBLIC ENTITIES.—
p.000929: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Center for Mental Health Services,
p.000929: shall make grants to public entities for the purpose of providing com- prehensive community mental health
p.000929: services to children with a serious emotional disturbance, which may include efforts to identify and serve
p.000929: children at risk.
p.000929: (2) DEFINITION OF PUBLIC ENTITY.—For purposes of this part, the term ‘‘public entity’’ means any
p.000929: State, any political subdivision of a State, and any Indian tribe or tribal organiza- tion (as defined in section
p.000929: 4(b) and section 4(c) of the Indian Self-Determination and Education Assistance Act).
p.000929: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000929: (1) REQUIREMENT OF STATUS AS GRANTEE UNDER PART B OF TITLE XIX.—The Secretary may make a grant under
p.000929: subsection
p.000929: (a) to a public entity only if—
p.000929: (A) in the case of a public entity that is a State, the State is such a grantee under section 1911;
p.000929: (B) in the case of a public entity that is a political sub- division of a State, the State in which the political
p.000929: subdivi- sion is located is such a grantee; and
p.000929: (C) in the case of a public entity that is an Indian tribe or tribal organization, the State in which the
p.000929: tribe or tribal organization is located is such a grantee.
p.000929: (2) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000929: (A) Subject to subparagraph (B), the Secretary may make a grant under subsection (a) only if, in the
p.000929: case of any service under such subsection that is covered in the State plan approved under title XIX of the
p.000929: Social Security Act for the State involved—
p.000929: (i) the public entity involved will provide the serv- ice directly, and the entity has entered into a partici-
p.000929: pation agreement under the State plan and is quali- fied to receive payments under such plan; or
p.000929: (ii) the public entity will enter into an agreement with an organization under which the organization
p.000929: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000929: Sec. 561 PUBLIC HEALTH SERVICE ACT 930
p.000929:
p.000929: will provide the service, and the organization has en- tered into such a participation agreement and is quali-
p.000929: fied to receive such payments.
p.000929: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000929: services under subsection (a), the requirement established in such subparagraph regarding a participation
p.000929: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000929: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000929: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000929: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000929: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000929: garding the provision of services to the public.
p.000929: (3) CERTAIN CONSIDERATIONS.—In making grants under subsection (a), the Secretary shall—
p.000929: (A) equitably allocate such assistance among the prin- cipal geographic regions of the United States;
p.000929: (B) consider the extent to which the public entity in- volved has a need for the grant; and
p.000929: (C) in the case of any public entity that is a political subdivision of a State or that is an Indian
p.000929: tribe or tribal organization—
p.000929: (i) shall consider any comments regarding the ap- plication of the entity for such a grant that are re-
p.000929: ceived by the Secretary from the State in which the entity is located; and
p.000929: (ii) shall give special consideration to the entity if the State agrees to provide a portion of the non-Fed-
p.000929: eral contributions required in subsection (c) regarding such a grant.
p.000929: (c) MATCHING FUNDS.—
p.000929: (1) IN GENERAL.—A funding agreement for a grant under subsection (a) is that the public entity involved
p.000929: will, with re- spect to the costs to be incurred by the entity in carrying out the purpose described
p.000929: in such subsection, make available (di- rectly or through donations from public or private entities)
p.000929: non-Federal contributions toward such costs in an amount that—
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p.000929: (A) for the first fiscal year for which the entity re- ceives payments from a grant under such subsection, is
p.000929: not less than $1 for each $3 of Federal funds provided in the grant;
p.000929: (B) for any second or third such fiscal year, is not less than $1 for each $3 of Federal funds provided in the grant;
p.000929: (C) for any fourth such fiscal year, is not less than $1 for each $1 of Federal funds provided in the grant; and
p.000929: (D) for any fifth and sixth such fiscal year, is not less than $2 for each $1 of Federal funds provided in the grant.
p.000929: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—
p.000929: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000957: have in effect transfer agreements with such hospital; except that the Secretary may, at the re- quest of the
p.000957: State agency, waive compliance with clause (A) or (B), or both such clauses, as the case may be, in the
p.000957: case of any project if the State agency has determined that compliance with such clause or clauses in such case would
p.000957: be inadvisable.
p.000957: (b) The Surgeon General shall approve any State plan and any modification thereof which complies with the
p.000957: provisions of sub- section (a). If any such plan or modification thereof shall have been disapproved by the Surgeon
p.000957: General for failure to comply with sub- section (a), the Federal Hospital Council shall, upon request of the
p.000957: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000959: 959
p.000959: PUBLIC HEALTH SERVICE ACT
p.000959: Sec. 605
p.000959:
p.000959: State agency, afford it an opportunity for hearing. If such Council determines that the plan or
p.000959: modification complies with the provi- sions of such subsection, the Surgeon General shall thereupon ap-
p.000959: prove such plan or modification.
p.000959: APPROVAL OF PROJECTS FOR CONSTRUCTION OR MODERNIZATION
p.000959: SEC. 605. ø291e¿ (a) For each project pursuant to a State plan approved under this part, there shall be submitted to
p.000959: the Surgeon General, through the State agency, an application by the State or a political subdivision
p.000959: thereof or by a public or other nonprofit agency. If two or more such agencies join in the project, the appli-
p.000959: cation may be filed by one or more of such agencies. Such applica- tion shall set forth—
p.000959: (1) a description of the site for such project;
p.000959: (2) plans and specifications therefor, in accordance with regulations prescribed under section 603;
p.000959: (3) reasonable assurance that title to such site is or will be vested on one or more of the agencies filing the
p.000959: application or in a public or other nonprofit agency which is to operate the facility on completion of the
p.000959: project;
p.000959: (4) reasonable assurance that adequate financial support will be available for the completion of the
p.000959: project and for its maintenance and operation when completed;
p.000959: (5) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the
p.000959: performance of construction or modernization on the project will be paid wages at rates not less than
p.000959: those prevailing on similar work in the locality as determined by the Secretary of Labor in ac- cordance
p.000959: with the Davis-Bacon Act, as amended (40 U.S.C. 276a—276a–5); and the Secretary of Labor shall have with re-
p.000959: spect to the labor standards specified in this paragraph the au- thority and functions set forth in
p.000959: Reorganization Plan Num- bered 14 of 1950 (15 F.R. 3176; 5 U.S.C. 133z–15) and section 2 of the Act of June 13,
p.000959: 1934, as amended (40 U.S.C. 276c); and
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p.000959: Sec. 606 PUBLIC HEALTH SERVICE ACT 960
p.000959:
p.000959: the comprehensive regional, metropolitan area, or other local area plan or plans referred to in section
p.000959: 314(b) covering the area in which such project is to be located or, if there is no such agency or
p.000959: organization, by the State agency administering or supervising the administration of the State plan approved
p.000959: under section 314(a), and the application is for a project which is entitled to priority over other projects within
p.000959: the State in accordance with the regulations prescribed pursuant to section 603(a). Notwithstanding the
p.000959: pre- ceding sentence, the Surgeon General may approve such an appli- cation for a project for construction or
p.000959: modernization of a rehabili- tation facility only if it is also approved by the Secretary of Health, Education, and
p.000959: Welfare.
p.000959: (c) No application shall be disapproved until the Surgeon Gen- eral has afforded the State agency an opportunity for a
p.000959: hearing.
p.000959: (d) Amendment of any approved application shall be subject to approval in the same manner as an original application.
p.000959: (e) Notwithstanding any other provision of this title, no appli- cation for an outpatient facility shall
p.000959: be approved under this sec- tion unless the applicant is (1) a State, political subdivision, or public
p.000959: agency, or (2) a corporation or association which owns and operates a nonprofit hospital (as defined in
p.000959: section 645) or which provides reasonable assurance that the services of a general hos- pital will be
p.000959: available to patients of such facility who are in need of hospital care.
p.000959:
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p.000959: PAYMENTS FOR CONSTRUCTION OR MODERNIZATION
p.000959: SEC. 606. ø291f¿ (a) Upon certification to the Surgeon General by the State agency, based upon inspection by
p.000959: it, that work has been performed upon a project, or purchases have been made, in accordance with the
p.000959: approved plans and specifications, and that payment of an installment is due to the applicant, such installment
p.000959: shall be paid to the State, from the applicable allotment of such State, except that (1) if the State is not
p.000959: authorized by law to make payments to the applicant, or if the State so requests, the payment shall be made directly to
p.000959: the applicant, (2) if the Surgeon General, after investigation or otherwise, has reason to believe that any act (or
p.000959: failure to act) has occurred requiring action pursuant to section 607, payment may, after he has given the
p.000959: State agency notice of opportunity for hearing pursuant to such section, be withheld, in whole or in part,
p.000959: pending corrective action or action based on such hearing, and (3) the total of payments under this subsection
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p.001073: to any per- son other than the individual who is the subject of such data unless (i) such person requires
p.001073: such data for purposes of this section, or (ii) in response to a demand for such data made by means of
p.001073: compulsory legal process. Any indi- vidual who is the subject of personal data made available or disclosed
p.001073: under clause (ii) shall be notified of the de- mand for such data.
p.001073: (B) Subject to all applicable laws regarding confiden- tiality, only the data collected by the Secretary under
p.001073: this section which is not personal data shall be made available to bona fide researchers and policy analysts (including
p.001073: the Congress) for the purposes of assisting in the conduct of studies respecting health professions personnel.
p.001073:
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p.001073: 18 So in law. Probably should be redesignated as (d).
p.001073: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001075: PUBLIC HEALTH SERVICE ACT
p.001075: Sec. 794
p.001075:
p.001075: (4) DEFINITION.—For purposes of this subsection, the term ‘‘program entity’’ means any public or private entity which
p.001075: col- lects, compiles, or analyzes health professions data under a grant, contract, or other arrangement with
p.001075: the Secretary under this section.
p.001075: (g) 19 TECHNICAL ASSISTANCE.—The Secretary shall provide technical assistance to the States and political
p.001075: subdivisions thereof in the development of systems (including model laws) concerning confidentiality and
p.001075: comparability of data collected pursuant to this section.
p.001075: (h) 20 GRANTS AND CONTRACTS REGARDING NONPROFIT ENTI-
p.001075: TIES.—
p.001075: (1) IN GENERAL.—In carrying out subsection (a), the Sec- retary may make grants, or enter into contracts
p.001075: and coopera- tive agreements with, and provide technical assistance to, any nonprofit entity in order to
p.001075: establish a uniform allied health professions data reporting system to collect, compile, and ana- lyze data on the
p.001075: allied health professions personnel.
p.001075: (2) REPORTS.—With respect to reports required in sub- section (d), each such report made on or after October 1,
p.001075: 1991, shall include a description and analysis of data collected pursu- ant to paragraph (1).
p.001075: SEC. 794. 21 ø295m¿ PROHIBITION AGAINST DISCRIMINATION ON BASIS OF SEX.
p.001075: The Secretary may not make a grant, loan guarantee, or inter- est subsidy payment under this title to, or for
p.001075: the benefit of, any school of medicine, osteopathic medicine, dentistry, veterinary med- icine, optometry, pharmacy,
p.001075: podiatric medicine, or public health or any training center for allied health personnel, or graduate pro- gram
p.001075: in clinical psychology, unless the application for the grant, loan guarantee, or interest subsidy payment
p.001075: contains assurances satisfactory to the Secretary that the school or training center will not discriminate on the
p.001075: basis of sex in the admission of individuals to its training programs. The Secretary may not enter into a
p.001075: con- tract under this title with any such school or training center unless the school, training center, or
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p.001121: to coordinate its work with the Community Preventive Services Task Force and the Advisory Committee on
p.001121: Immunization Practices, including the examination of how each task force’s recommendations interact at the
p.001121: nexus of clinic and commu- nity.
p.001121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001121: Sec. 916 PUBLIC HEALTH SERVICE ACT 1122
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p.001121: January 30, 2020
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p.001121: (5) OPERATION.—Operation. In carrying out the duties under paragraph (2), the Task Force is not subject to
p.001121: the provi- sions of Appendix 2 of title 5, United States Code.
p.001121: (6) INDEPENDENCE.—All members of the Task Force con- vened under this subsection, and any recommendations
p.001121: made by such members, shall be independent and, to the extent prac- ticable, not subject to political pressure.
p.001121: (7) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated such sums as may be necessary
p.001121: for each fiscal year to carry out the activities of the Task Force.
p.001121: (b) PRIMARY CARE RESEARCH.—
p.001121: (1) IN GENERAL.—There is established within the Agency a Center for Primary Care Research (referred to in this
p.001121: sub- section as the ‘‘Center’’) that shall serve as the principal source of funding for primary care practice
p.001121: research in the Depart- ment of Health and Human Services. For purposes of this paragraph, primary care
p.001121: research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral
p.001121: to specialty care, preventive care, and the relation- ship between the clinician and the patient in the context
p.001121: of the family and community.
p.001121: (2) RESEARCH.—In carrying out this section, the Center shall conduct and support research concerning—
p.001121: (A) the nature and characteristics of primary care practice;
p.001121: (B) the management of commonly occurring clinical problems;
p.001121: (C) the management of undifferentiated clinical prob- lems; and
p.001121: (D) the continuity and coordination of health services.
p.001121: SEC. 916. ø299b–5¿ HEALTH CARE PRACTICE AND TECHNOLOGY INNO- VATION.
p.001121: (a) IN GENERAL.—The Director shall promote innovation in evi- dence-based health care practices and technologies by—
p.001121: (1) conducting and supporting research on the develop- ment, diffusion, and use of health care technology;
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p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: PUBLIC HEALTH SERVICE ACT
p.001169: Sec. 1109
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p.001169: (A) the collection, delivery, receipt, and screening of specimens; and
p.001169: (B) the diagnosis of heritable disorders in newborns.
p.001169: (b) ELIGIBLE ENTITY.—In this section, the term ‘‘eligible entity’’ means—
p.001169: (1) a State or a political subdivision of a State;
p.001169: (2) a consortium of 2 or more States or political subdivi- sions of States;
p.001169: (3) a territory;
p.001169: (4) a health facility or program operated by or pursuant to a contract with or grant from the Indian Health Service; or
p.001169: (5) any other entity with appropriate expertise in newborn screening, as determined by the Secretary.
p.001169: (c) APPROVAL FACTORS.—An application for a grant under this section shall not be approved by the Secretary
p.001169: unless the applica- tion contains assurances that the eligible entity has adopted and implemented, is in
p.001169: the process of adopting and implementing, or will use amounts received under such grant to adopt and
p.001169: imple- ment the guidelines and recommendations of the Advisory Com- mittee that are adopted by the Secretary
p.001169: and in effect at the time the grant is awarded or renewed under this section, which shall in- clude the screening of
p.001169: each newborn for the heritable disorders rec- ommended by the Advisory Committee and adopted by the Sec-
p.001169: retary.
p.001169: (d) COORDINATION.—The Secretary shall take all necessary
p.001169: steps to coordinate programs funded with grants received under this section and to coordinate with
p.001169: existing newborn screening ac- tivities.
p.001169: (e) LIMITATION.—An eligible entity may not use amounts re- ceived under this section to—
p.001169: (1) provide cash payments to or on behalf of affected indi- viduals;
p.001169: (2) provide inpatient services;
p.001169: (3) purchase land or make capital improvements to prop- erty; or
p.001169: (4) provide for proprietary research or training.
p.001169: (f) VOLUNTARY PARTICIPATION.—The participation by any indi- vidual in any program or portion thereof
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p.001169: designed to evaluate and assess, within the jurisdiction of the entity receiving such grant—
p.001169: (1) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services for
p.001169: newborns and chil- dren at risk for heritable disorders in reducing the morbidity and mortality associated
p.001169: with such disorders, including, as ap- propriate, through the assessment of health and development outcomes for
p.001169: such children through adolescence;
p.001169: (2) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services in
p.001169: accurately and reli- ably diagnosing heritable disorders in newborns and children in a timely manner;
p.001169: (3) the availability of screening, counseling, testing or spe- cialty services for newborns and children at risk
p.001169: for heritable disorders;
p.001169: (4) methods that may be identified to improve quality in the diagnosis, treatment, and disease management of
p.001169: heritable disorders based on gaps in services or care; or
p.001169: (5) methods or best practices by which the eligible entities described in section 1109 can achieve in a timely manner—
p.001169: (A) collection, delivery, receipt, and screening of new- born screening specimens; and
p.001169: (B) diagnosis of heritable disorders in newborns.
p.001169: (c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under subsection (a) an entity shall be a State or
p.001169: political subdivision of a State, or a consortium of two or more States or political subdivi- sions of States.
p.001169: SEC. 1111. ø300b–10¿ ADVISORY COMMITTEE ON HERITABLE DIS- ORDERS IN NEWBORNS AND CHILDREN.
p.001169: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the ‘‘Advisory Committee
p.001169: on Heritable Disorders in Newborns and Children’’ (referred to in this section as the ‘‘Advisory Committee’’).
p.001169: (b) DUTIES.—The Advisory Committee shall—
p.001169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001171: 1171
p.001171: PUBLIC HEALTH SERVICE ACT
p.001171: Sec. 1111
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p.001171: (1) provide advice and recommendations to the Secretary concerning grants and projects awarded or funded
p.001171: under sec- tion 1109;
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p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
p.001179: (6) by increasing communication and coordination with State trauma systems.
p.001179: (b) SPECIAL CONSIDERATION FOR CERTAIN RURAL AREAS.—In making grants under subsection (a), the
p.001179: Secretary shall give spe- cial consideration to any applicant for the grant that will provide services
p.001179: under the grant in any rural area identified by a State under section 1214(d)(1).
p.001179: (c) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.001179: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001179: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: 1181
p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001221: method and data used in calculating the rates of pay- ment.
p.001221: (D) The following differentials in rates of payments may be es- tablished under the systems described in
p.001221: subparagraphs (B) and (C):
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p.001221: January 30, 2020
p.001221: (i) Nominal differentials in such rates may be established to reflect differences in marketing costs and
p.001221: the different ad- ministrative costs of collecting payments from the following categories of members:
p.001221: (I) Individual members (including their families).
p.001221: (II) Small groups of members (as determined under regulations of the Secretary).
p.001221: (III) Large groups of members (as determined under regulations of the Secretary).
p.001221: (ii) Nominal differentials in such rates may be established to reflect the compositing of the rates of payment in a
p.001221: system- atic manner to accommodate group purchasing practices of the various employers.
p.001221: (iii) Differentials in such rates may be established for members enrolled in a health maintenance organization
p.001221: pursu- ant to a contract with a governmental authority under section 1079 or 1086 of title 10, United States
p.001221: Code, or under any other governmental program (other than the health benefits program authorized by
p.001221: chapter 89 of title 5, United States Code) or any health benefits program for employees of States,
p.001221: political subdivision of States, and other public entities.
p.001221: (9) The term ‘‘non-metropolitan area’’ means an area no part of which is within an area designated as
p.001221: a standard metropolitan
p.001221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001223: 1223
p.001223: PUBLIC HEALTH SERVICE ACT
p.001223: Sec. 1305
p.001223:
p.001223: statistical area by the Office of Management and Budget and which does not contain a city whose population exceeds
p.001223: fifty thousand in- dividuals.
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p.001223: January 30, 2020
p.001223: LOANS AND LOAN GUARANTEES FOR INITIAL COSTS OF OPERATION
p.001223: SEC. 1305. ø300e–4¿ (a) The Secretary may—
p.001223: (1) make loans to public or private health maintenance or- ganizations to assist them in meeting the amount by
p.001223: which their costs of operation during a period not to exceed the first sixty months of their operation
p.001223: exceed their revenues in that period;
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p.001229: SEC. 1310. 3 ø300e–9¿ (a) In accordance with regulations which the Secretary shall prescribe—
p.001229:
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p.001229: January 30, 2020
p.001229: 3 Section 1310 as shown above was added by section 7(b) of Public Law 100–517. Such section provided in part as
p.001229: follows: ‘‘Effective 7 years after the date of the enactment of this Act øOcto- ber 24, 1988¿, section 1310 (42 U.S.C.
p.001229: 300e–9) is amended to read as follows’’.
p.001229: Section 7(a)(3) of such Public Law provides that nothing in section 1310 shall be construed to supersede
p.001229: any provision of a collective bargaining agreement in effect on øOctober 24, 1988¿.
p.001229: Continued
p.001229: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001229: Sec. 1310 PUBLIC HEALTH SERVICE ACT 1230
p.001229:
p.001229: (1) each employer—
p.001229: (A) which is required during any calendar quarter to pay its employees the minimum wage prescribed by section 6
p.001229: of the Fair Labor Standards Act of 1938 (or would be re- quired to pay its employees such wage but for section 13(a) of
p.001229: such Act), and
p.001229: (B) which during such calendar quarter employed an average number of employees of not less than 25, and
p.001229: (2) any State and each political subdivision thereof which during any calendar quarter employed an
p.001229: average number of employees of not less than 25, as a condition of payment to the State of funds under section 317,
p.001229: 318, or 1002,
p.001229: which offers to its employees in the calendar year beginning after such calendar quarter the option of
p.001229: membership in a qualified health maintenance organization which is engaged in the provision of basic health services
p.001229: in a health maintenance organization serv- ice area in which at least 25 of such employees reside shall
p.001229: meet the requirements of subsection (b) with respect to any qualified health maintenance organization
p.001229: offered by the employer or State or political subdivision.
p.001229: (b)(1) If a health benefits plan offered by an employer or a State or political subdivision includes
p.001229: contributions for services of- fered under the plan, the employer or State or political subdivision shall make a
p.001229: contribution under the plan for services offered by a qualified health maintenance organization in an
p.001229: amount which does not financially discriminate against an employee who enrolls in such organization. For
p.001229: purposes of the preceding sentence, an employer’s or a State’s or political subdivision’s contribution
p.001229: does not financially discriminate if the employer’s or State’s or political subdivision’s method of
p.001229: determining the contributions on behalf of all employees is reasonable and is designed to assure
p.001229: employees a fair choice among health benefits plans.
p.001229: (2) Each employer or State or political subdivision which pro- vides payroll deductions as a means of paying
p.001229: employees’ contribu- tions for health benefits or which provides a health benefits plan to which an
p.001229: employee contribution is not required shall, with the consent of an employee who exercises option of
p.001229: membership in a qualified health maintenance organization, arrange for the employ- ee’s contribution for
p.001229: membership in the organization to be paid through payroll deductions.
p.001229: (3) No employer or State or political subdivision shall be re- quired to pay more for health benefits as a
p.001229: result of the application of this subsection than would otherwise be required by any pre- vailing collective
p.001229: bargaining agreement or other legally enforceable contract for the provision of health benefits between the
p.001229: employer or State or political subdivision and its employees.
p.001229: (c) For purposes of this section, the term ‘‘qualified health maintenance organization’’ means (1) a health
p.001229: maintenance organi- zation which has provided assurances satisfactory to the Secretary
p.001229:
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p.001229: January 30, 2020
p.001229: Section 9 of such Public Law provides as follows: ‘‘With respect to abortion services, the Sec- retary of Health and
p.001229: Human Services shall not promulgate or issue any regulations, policy statements, or interpretations or
p.001229: develop any practices concerning the performance of medically necessary procedures if such regulations, policy
p.001229: statements, interpretations, or practices would be inconsistent with those in effect on øOctober 24, 1988¿.’’.
p.001229: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001231: PUBLIC HEALTH SERVICE ACT
p.001231: Sec. 1310
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p.001231: States in a United States district court.
p.001231: (2) In any proceeding by the Secretary to assess a civil penalty under this subsection, no penalty shall be
p.001231: assessed until the em- ployer charged shall have been given notice and an opportunity to present its views on such
p.001231: charge. In determining the amount of the penalty, or the amount agreed upon in compromise, the Secretary shall
p.001231: consider the gravity of the noncompliance and the dem- onstrated good faith of the employer charged in
p.001231: attempting to achieve rapid compliance after notification by the Secretary of a noncompliance.
p.001231: (3) In any civil action brought to review the assessment of a civil penalty assessed under this subsection,
p.001231: the court shall, at the request of any party to such action, hold a trial de novo on the as- sessment of such civil
p.001231: penalty and in any civil action to collect such a civil penalty, the court shall, at the request of any party to such
p.001231: action, hold a trial de novo on the assessment of such civil penalty unless in a prior civil action to review the
p.001231: assessment of such pen- alty the court held a trial de novo on such assessment.
p.001231: (e) For purposes of this section, the term ‘‘employer’’ does not include (1) the Government of the
p.001231: United States, the government of the District of Columbia or any territory or possession of the United
p.001231: States, a State or any political subdivision thereof, or any agency or instrumentality (including the United
p.001231: States Postal Serv- ice and Postal Rate Commission) of any of the foregoing, except that such term includes
p.001231: nonappropriated fund instrumentalities of the Government of the United States; or (2) a church, convention or
p.001231: association of churches, or any organization operated, supervised or controlled by a church, convention or
p.001231: association of churches which organization (A) is an organization described in section 501(c)(3) of the
p.001231: Internal Revenue Code of 1986, and (B) does not discriminate (i) in the employment, compensation,
p.001231: promotion, or termination of employment of any personnel, or (ii) in the extension of staff or other privileges
p.001231: to any physician or other health per- sonnel, because such persons seek to obtain or obtained health
p.001231: care, or participate in providing health care, through a health maintenance organization.
p.001231: (f) If the Secretary, after reasonable notice and opportunity for a hearing to a State, finds that it or any of its
p.001231: political subdivisions
p.001231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001231: Sec. 1311 PUBLIC HEALTH SERVICE ACT 1232
p.001231: has failed to comply with paragraph (1) or (2) of subsection (b), the Secretary shall terminate payments to such
p.001231: State under sections 317, 318, and 1002 and notify the Governor of such State that fur- ther payments under such
p.001231: sections will not be made to the State until the Secretary is satisfied that there will no longer be
p.001231: any such failure to comply.
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p.001231: January 30, 2020
p.001231:
p.001231: RESTRICTIVE STATE LAWS AND PRACTICES
p.001231: SEC. 1311. ø300e–10¿ (a) In the case of any entity—
p.001231: (1) which cannot do business as a health maintenance or- ganization in a State in which it proposes to furnish
p.001231: basic and supplemental health services because that State by law, regu- lation, or otherwise—
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p.001251: (2) The Secretary may take such action, consistent with State law respecting foreclosure procedures, as
p.001251: he deems appropriate to protect the interest of the United States in the event of a default on a loan
p.001251: made or guaranteed under this part or under title VI, in- cluding selling real property pledged as security for such a
p.001251: loan or loan guarantee and for a reasonable period of time taking posses- sion of, holding, and using
p.001251: real property pledged as security for such a loan or loan guarantee.
p.001251: PART B—PROJECT GRANTS
p.001251:
p.001251:
p.001251:
p.001251:
p.001251:
p.001251: January 30, 2020
p.001251: PROJECT GRANTS
p.001251: SEC. 1610. ø300r¿ (a)(1)(A) The Secretary may make grants for construction or modernization projects designed to—
p.001251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001251:
p.001253: 1253
p.001253: PUBLIC HEALTH SERVICE ACT
p.001253: Sec. 1610
p.001253:
p.001253: (i) eliminate or prevent in medical facilities imminent safe- ty hazards as defined by Federal, State, or local fire,
p.001253: building, or life safety codes or regulations, or
p.001253: (ii) avoid noncompliance by medical facilities with State or voluntary licensure or accreditation standards.
p.001253: (B) A grant under subparagraph (A) may only be made to—
p.001253: (i) a State or political subdivision of a State, including any city, town, county, borough, hospital district
p.001253: authority, or pub- lic or quasi-public corporation, for any medical facility owned or operated by the State or
p.001253: political subdivision; and
p.001253: (ii) a nonprofit private entity for any medical facility owned or operated by the entity but only if
p.001253: the Secretary deter- mines—
p.001253:
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p.001253: January 30, 2020
p.001253: (I) the level of community service provided by the fa- cility and the proportion of its patients who are
p.001253: unable to pay for services rendered in the facility is similar to such level and proportion in a medical
p.001253: facility of a State or po- litical subdivision, and
p.001253: (II) that without a grant under subparagraph (A) there would be a disruption of the provision of health
p.001253: care to low-income individuals.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 75 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
p.001253: rural poverty area, in which case the grant may cover up to 100 per centum of such costs.
p.001253: (3) There are authorized to be appropriated for grants under paragraph (1) $40,000,000 for the fiscal year
p.001253: ending September 30, 1980, $50,000,000 for the fiscal year ending September 30, 1981, and $50,000,000 for
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p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
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p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
p.001333:
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p.001387: 16th through the 18th month after such date ............................. 225
p.001387: 19th through the 21st month after such date .............................. 263
p.001387: 22nd through the 24th month after such date ............................. 300
p.001387: 25th through the 27th month after such date ............................. 338
p.001387: 28th through the 30th month after such date ............................. 375
p.001387: 31st through the 33rd month after such date .............................. 413
p.001387: 34th through the 36th month after such date ............................. 450
p.001387: 37th through the 39th month after such date ............................. 488
p.001387: 40th through the 42nd month after such date ............................. 525
p.001387: 43rd through the 45th month after such date ............................. 563
p.001387: 46th through the 48th month after such date ............................. 600.
p.001387:
p.001387: TITLE XXII—REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EM- PLOYEES
p.001387: SEC. 2201. ø300bb–1¿ STATE AND LOCAL GOVERNMENTAL GROUP HEALTH PLANS MUST PROVIDE CONTINUATION
p.001387: COV- ERAGE TO CERTAIN INDIVIDUALS.
p.001387: (a) IN GENERAL.—In accordance with regulations which the Secretary shall prescribe, each group health plan
p.001387: that is main- tained by any State that receives funds under this Act, by any po- litical subdivision of such a
p.001387: State, or by any agency or instrumen- tality of such a State or political subdivision, shall provide,
p.001387: in ac- cordance with this title, that each qualified beneficiary who would lose coverage under the plan as a
p.001387: result of a qualifying event is en- titled, under the plan, to elect, within the election period, continu- ation
p.001387: coverage under the plan.
p.001387: (b) EXCEPTION FOR CERTAIN PLANS.—Subsection (a) shall not apply to—
p.001387: (1) any group health plan for any calendar year if all em- ployers maintaining such plan normally
p.001387: employed fewer than 20 employees on a typical business day during the preceding calendar year, or
p.001387: (2) any group health plan maintained for employees by the government of the District of Columbia or any territory or
p.001387: pos- session of the United States or any agency or instrumentality.
p.001387: SEC. 2202. ø300bb–2¿ CONTINUATION COVERAGE.
p.001387: For purposes of section 2201, the term ‘‘continuation coverage’’ means coverage under the plan which meets the
p.001387: following require- ments:
p.001387:
p.001387:
p.001387:
p.001387:
p.001387:
p.001387: January 30, 2020
p.001387: (1) TYPE OF BENEFIT COVERAGE.—The coverage must con- sist of coverage which, as of the time the coverage is
p.001387: being pro- vided, is identical to the coverage provided under the plan to similarly situated beneficiaries
p.001387: under the plan with respect to whom a qualifying event has not occurred. If coverage is modi-
p.001387: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001387:
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p.001443: Cen- ters for Disease Control and Prevention) as of December 31 of the most recent calendar year for which such data is
p.001443: available.
p.001443: (c) BOUNDARIES.—For purposes of determining eligibility under this subpart—
p.001443: (1) with respect to a metropolitan area that received fund- ing under this subpart in fiscal year 2006, the
p.001443: boundaries of such metropolitan area shall be the boundaries that were in ef- fect for such area for fiscal year 1994;
p.001443: or
p.001443: (2) with respect to a metropolitan area that becomes eligi- ble to receive funding under this subpart in any
p.001443: fiscal year after fiscal year 2006, the boundaries of such metropolitan area shall be the boundaries that are in
p.001443: effect for such area when such area initially receives funding under this subpart.
p.001443: SEC. 2602. ø300ff–12¿ ADMINISTRATION AND PLANNING COUNCIL.
p.001443: (a) ADMINISTRATION.—
p.001443: (1) IN GENERAL.—Assistance made available under grants awarded under this subpart shall be directed to the chief
p.001443: elect- ed official of the city or urban county that administers the pub- lic health agency that provides
p.001443: outpatient and ambulatory services to the greatest number of individuals with AIDS, as reported to and
p.001443: confirmed by the Centers for Disease Control and Prevention, in the eligible area that is awarded such
p.001443: a grant.
p.001443: (2) REQUIREMENTS.—
p.001443: (A) IN GENERAL.—To receive assistance under section 2601(a), the chief elected official of the eligible
p.001443: area in- volved shall—
p.001443: (i) establish, through intergovernmental agree- ments with the chief elected officials of the political
p.001443: subdivisions described in subparagraph (B), an admin- istrative mechanism to allocate funds and services based
p.001443: on—
p.001443: (I) the number of AIDS cases in such subdivi- sions;
p.001443: (II) the severity of need for outpatient and ambulatory care services in such subdivisions; and
p.001443: (III) the health and support services per- sonnel needs of such subdivisions; and
p.001443: (ii) establish an HIV health services planning council in accordance with subsection (b).
p.001443: (B) LOCAL POLITICAL SUBDIVISION.—The political sub- divisions referred to in subparagraph (A) are those
p.001443: polit- ical subdivisions in the eligible area—
p.001443: (i) that provide HIV-related health services; and
p.001443: (ii) for which the number of cases reported for purposes of section 2601(a) constitutes not less than
p.001443: 10 percent of the number of such cases reported for the eligible area.
p.001443: (b) HIV HEALTH SERVICES PLANNING COUNCIL.—
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001443:
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p.001443: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1444
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p.001443: January 30, 2020
p.001443:
p.001443: (1) ESTABLISHMENT.—To be eligible for assistance under this subpart, the chief elected official described
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p.001451: area in order to ad- just for duplicative reporting in and among sys- tems that use code-based reporting.
p.001451: (II) ADJUSTMENT RATE.—The adjustment rate under subclause (I) for an eligible area shall be a reduction of 5
p.001451: percent for fiscal years before fiscal year 2012 (and 6 percent for fiscal year 2012) in the number of
p.001451: living non-AIDS cases of HIV re- ported for the area.
p.001451: (III) INCREASED ADJUSTMENT FOR CERTAIN AREAS PREVIOUSLY USING CODE-BASED REPORT- ING.—For
p.001451: purposes of this subparagraph for each of fiscal years 2010 through 2012, the Secretary shall deem the
p.001451: applicable number of living cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for
p.001451: Disease Control and Prevention to be 3 percent higher than the actual number if—
p.001451: (aa) for fiscal year 2007, such area was a transitional area;
p.001451: (bb) fiscal year 2007 was the first year in which the count of living non-AIDS cases of HIV in such area, for
p.001451: purposes of this section, was based on a names-based reporting sys- tem; and
p.001451: (cc) the amount of funding that such area received under this part for fiscal year 2007 was less than 70
p.001451: percent of the amount of funding (exclusive of funds that were identi- fied as being for purposes of
p.001451: the Minority AIDS Initiative) that such area received under such part for fiscal year 2006.
p.001451: (vii) MULTIPLE POLITICAL JURISDICTIONS.—With respect to living non-AIDS cases of HIV, if an eligible area is
p.001451: not entirely within one political jurisdiction and as a result is subject to more than one reporting
p.001451: system for purposes of this subparagraph:
p.001451: (I) Names-based reporting under clause (i) ap- plies in a jurisdictional portion of the area, or an exemption
p.001451: under clause (ii) applies in such portion (subject to applicable provisions of this subpara- graph), according
p.001451: to whether names-based report- ing or code-based reporting is used in such por- tion.
p.001451: (II) If under subclause (I) both names-based reporting and code-based reporting apply in the area, the
p.001451: number of code-based cases shall be re- duced under clause (vi).
p.001451: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001451:
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p.001451: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1452
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p.001451: January 30, 2020
p.001451:
p.001451: (viii) LIST OF ELIGIBLE AREAS MEETING STANDARD REGARDING DECEMBER 31, 2005.—
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p.001457: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of subsection (a)(4);
p.001457: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001457:
p.001459: 1459
p.001459: PUBLIC HEALTH SERVICE ACT
p.001459: Sec. 2604
p.001459:
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p.001459: January 30, 2020
p.001459: (3) the amount of supplemental funds disbursed pursuant to subsection (b)(2)(C);
p.001459: (4) the disbursement of the remainder of the supplemental funds after taking into account the uses described in
p.001459: para- graphs (2) and (3); and
p.001459: (5) the rationale used for the amount of funds disbursed as described under paragraphs (2), (3), and (4).
p.001459: SEC. 2604. ø300ff–14¿ USE OF AMOUNTS.
p.001459: (a) REQUIREMENTS.—The Secretary may not make a grant under section 2601(a) to the chief elected official
p.001459: of an eligible area unless such political subdivision agrees that—
p.001459: (1) subject to paragraph (2), the allocation of funds and services within the eligible area will be
p.001459: made in accordance with the priorities established, pursuant to section 2602(b)(4)(C), by the
p.001459: HIV health services planning council that serves such eligible area;
p.001459: (2) funds provided under section 2601 will be expended only for—
p.001459: (A) core medical services described in subsection (c);
p.001459: (B) support services described in subsection (d); and
p.001459: (C) administrative expenses described in subsection (h); and
p.001459: (3) the use of such funds will comply with the require- ments of this section.
p.001459: (b) DIRECT FINANCIAL ASSISTANCE TO APPROPRIATE ENTITIES.—
p.001459: (1) IN GENERAL.—The chief elected official of an eligible area shall use amounts from a grant under section
p.001459: 2601 to pro- vide direct financial assistance to entities described in para- graph (2) for the purpose of
p.001459: providing core medical services and support services.
p.001459: (2) APPROPRIATE ENTITIES.—Direct financial assistance may be provided under paragraph (1) to public or
p.001459: nonprofit pri- vate entities, or private for-profit entities if such entities are the only available provider
p.001459: of quality HIV care in the area.
p.001459: (c) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001459: (1) IN GENERAL.—With respect to a grant under section 2601 for an eligible area for a grant year, the chief
p.001459: elected offi- cial of the area shall, of the portion of the grant remaining after reserving amounts for
...

p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
p.001461: involved (infants, chil- dren, youth, or women in such area) with HIV/AIDS to the general population in
p.001461: such area of individuals with HIV/AIDS.
p.001461: (2) WAIVER.—With respect to the population involved, the Secretary may provide to the chief elected official of
p.001461: an eligible area a waiver of the requirement of paragraph (1) if such offi- cial demonstrates to the satisfaction
p.001461: of the Secretary that the population is receiving HIV-related health services through the State medicaid program
p.001461: under title XIX of the Social Security Act, the State children’s health insurance program under title XXI
p.001461: of such Act, or other Federal or State programs.
p.001461: (g) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.001461: (1) PROVISION OF SERVICE.—Subject to paragraph (2), the Secretary may not make a grant under section 2601(a) for
p.001461: the provision of services under this section in a State unless, in the case of any such service that is available
p.001461: pursuant to the State plan approved under title XIX of the Social Security Act for the State—
p.001461:
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p.001461: January 30, 2020
p.001461: (A) the political subdivision involved will provide the service directly, and the political subdivision
p.001461: has entered into a participation agreement under the State plan and is qualified to receive payments under such plan;
p.001461: or
p.001461: (B) the political subdivision will enter into an agree- ment with a public or nonprofit private entity under
p.001461: which the entity will provide the service, and the entity has en- tered into such a participation
p.001461: agreement and is qualified to receive such payments.
p.001461: (2) WAIVER.—
p.001461: (A) IN GENERAL.—In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the pro-
p.001461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: Sec. 2604 PUBLIC HEALTH SERVICE ACT 1462
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p.001461: January 30, 2020
p.001461:
p.001461: vision of services, the requirement established in such paragraph shall be waived by the HIV health
p.001461: services planning council for the eligible area if the entity does not, in providing health care services, impose
...

p.001463: program required in subparagraph (A) not to ex- ceed the lesser of—
p.001463: (I) 5 percent of amounts received under the grant; or
p.001463: (II) $3,000,000.
p.001463: (ii) RELATION TO LIMITATION ON ADMINISTRATIVE EXPENSES.—The costs of a clinical quality manage- ment
p.001463: program under subparagraph (A) may not be considered administrative expenses for purposes of the limitation
p.001463: established in paragraph (1).
p.001463: (i) CONSTRUCTION.—A chief elected official may not use amounts received under a grant awarded under
p.001463: this subpart to purchase or improve land, or to purchase, construct, or perma- nently improve (other
p.001463: than minor remodeling) any building or other facility, or to make cash payments to intended recipients
p.001463: of services.
p.001463: SEC. 2605. ø300ff–15¿ APPLICATION.
p.001463: (a) IN GENERAL.—To be eligible to receive a grant under sec- tion 2601, an eligible area shall prepare
p.001463: and submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001463: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001463: shall require, in- cluding assurances adequate to ensure—
p.001463: (1)(A) that funds received under a grant awarded under this subpart will be utilized to supplement not
p.001463: supplant State funds made available in the year for which the grant is award- ed to provide HIV-related
p.001463: services as described in section 2604(b)(1);
p.001463: (B) that the political subdivisions within the eligible area will maintain the level of expenditures by
p.001463: such political sub- divisions for HIV-related services as described in section 2604(b)(1) at a level
p.001463: that is equal to the level of such expendi- tures by such political subdivisions for the preceding fiscal year;
p.001463: and
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001463:
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p.001463: Sec. 2605 PUBLIC HEALTH SERVICE ACT 1464
p.001463:
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p.001463: January 30, 2020
p.001463:
p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
...

p.001521: section, including a description of Federal bar- riers to HIV program integration and a strategy for
p.001521: eliminating such barriers and enhancing the continuity of care and prevention services for individuals with HIV/AIDS or
p.001521: those at risk of such dis- ease.
p.001521: (c) INTEGRATION BY STATE.—As a condition of receipt of funds under this title, a State shall provide
p.001521: assurances to the Secretary that health support services funded under this title will be inte- grated with
p.001521: other such services, that programs will be coordinated with other available programs (including Medicaid), and
p.001521: that the continuity of care and prevention services of individuals with HIV/ AIDS is enhanced.
p.001521: (d) INTEGRATION BY LOCAL OR PRIVATE ENTITIES.—As a condi- tion of receipt of funds under this title, a
p.001521: local government or pri- vate nonprofit entity shall provide assurances to the Secretary that services funded
p.001521: under this title will be integrated with other such services, that programs will be coordinated with
p.001521: other available programs (including Medicaid), and that the continuity of care and prevention services of individuals
p.001521: with HIV is enhanced.
p.001521: SEC. 2682. ø300ff–82¿ AUDITS.
p.001521: (a) IN GENERAL.—For fiscal year 2009, and each subsequent fiscal year, the Secretary may reduce the amounts of
p.001521: grants under this title to a State or political subdivision of a State for a fiscal year if, with
p.001521: respect to such grants for the second preceding fiscal year, the State or subdivision fails to prepare audits
p.001521: in accordance with the procedures of section 7502 of title 31, United States Code. The Secretary shall annually select
p.001521: representative samples of such audits, prepare summaries of the selected audits, and submit the summaries to
p.001521: the Congress.
p.001521: (b) POSTING ON THE INTERNET.—All audits that the Secretary receives from the State lead agency under
p.001521: section 2617(b)(4) shall be posted, in their entirety, on the Internet website of the Health Resources and
p.001521: Services Administration.
p.001521: SEC. 2683. ø300ff–83¿ PUBLIC HEALTH EMERGENCY.
p.001521: (a) IN GENERAL.—In an emergency area and during an emer- gency period, the Secretary shall have the authority
p.001521: to waive such requirements of this title to improve the health and safety of those receiving care under this title
p.001521: and the general public, except that the Secretary may not expend more than 5 percent of the funds al- located
p.001521: under this title for sections 2620 and section 2603(b).
p.001521: (b) EMERGENCY AREA AND EMERGENCY PERIOD.—In this sec- tion:
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001593:
p.001593: (i) 19 substitutes for the reference to ‘‘6-month period’’ in section 2701(a)(1) a reference to any
p.001593: shorter period of time;
p.001593: (ii) 19 substitutes for the reference to ‘‘12 months’’ and ‘‘18 months’’ in section 2701(a)(2) a reference to any
p.001593: short- er period of time;
p.001593: (iii) 19 substitutes for the references to ‘‘63’’ days in sections 2701(c)(2)(A) and 2701(d)(4)(A) a
p.001593: reference to any greater number of days;
p.001593: (iv) 19 substitutes for the reference to ‘‘30-day period’’ in sections 2701(b)(2) and 2701(d)(1) a
p.001593: reference to any greater period;
p.001593: (v) 19 prohibits the imposition of any preexisting condi- tion exclusion in cases not described in section
p.001593: 2701(d) or expands the exceptions described in such section;
p.001593: (vi) 19 requires special enrollment periods in addition to those required under section 2701(f); or
p.001593: (vii) 19 reduces the maximum period permitted in an affiliation period under section 2701(g)(1)(B).
p.001593: (c) RULES OF CONSTRUCTION.—Nothing in this part (other than section 2704) shall be construed as requiring a
p.001593: group health plan or health insurance coverage to provide specific benefits under the terms of such plan or coverage.
p.001593: (d) DEFINITIONS.—For purposes of this section—
p.001593: (1) STATE LAW.—The term ‘‘State law’’ includes all laws, decisions, rules, regulations, or other State
p.001593: action having the effect of law, of any State. A law of the United States applica- ble only to the District of
p.001593: Columbia shall be treated as a State law rather than a law of the United States.
p.001593: (2) STATE.—The term ‘‘State’’ includes a State (including the Northern Mariana Islands), any political
p.001593: subdivisions of a
p.001593:
p.001593:
p.001593:
p.001593:
p.001593: January 30, 2020
p.001593: 19 Clauses (i) through (vii) probably should be redesignated as subparagraphs (A) through (G). See section 102(a) of
p.001593: Public Law 104–191 (110 Stat. 1971).
p.001593: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001593:
p.001593:
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p.001593:
p.001595: 1595
p.001595: PUBLIC HEALTH SERVICE ACT
p.001595: Sec. 2741
p.001595:
p.001595: State or such Islands, or any agency or instrumentality of ei- ther. 20
p.001595: PART B—INDIVIDUAL MARKET RULES 21
p.001595: Subpart 1—Portability, Access, and Renewability Requirements
p.001595: SEC. 2741. ø300gg–41¿ GUARANTEED AVAILABILITY OF INDIVIDUAL HEALTH INSURANCE COVERAGE TO CERTAIN
p.001595: INDIVID- UALS WITH PRIOR GROUP COVERAGE.
p.001595: (a) GUARANTEED AVAILABILITY.—
p.001595: (1) IN GENERAL.—Subject to the succeeding subsections of this section and section 2744, each health
p.001595: insurance issuer that offers health insurance coverage (as defined in section 2791(b)(1)) in the individual
p.001595: market in a State may not, with respect to an eligible individual (as defined in subsection (b))
p.001595: desiring to enroll in individual health insurance coverage—
p.001595: (A) decline to offer such coverage to, or deny enroll- ment of, such individual; or
p.001595: (B) impose any preexisting condition exclusion (as de- fined in section 2701(b)(1)(A)) with respect to
p.001595: such cov- erage.
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p.001647: (1) strengthening epidemiologic capacity to identify and monitor the occurrence of infectious diseases,
p.001647: including mos- quito and other vector-borne diseases, and other conditions of public health importance;
p.001647: (2) enhancing laboratory practice as well as systems to re- port test orders and results electronically;
p.001647: (3) improving information systems including developing and maintaining an information exchange using
p.001647: national guidelines and complying with capacities and functions deter- mined by an advisory council established
p.001647: and appointed by the Director; and
p.001647: (4) developing and implementing prevention and control strategies.
p.001647: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001647: $190,000,000 for each of fiscal years 2019 through 2023, of which—
p.001647: (1) not less than $95,000,000 shall be made available each such fiscal year for activities under paragraphs (1)
p.001647: and (4) of subsection (a);
p.001647: (2) not less than $60,000,000 shall be made available each such fiscal year for activities under subsection (a)(3); and
p.001647: (3) not less than $32,000,000 shall be made available each such fiscal year for activities under subsection (a)(2).
p.001647: SEC. 2822. ø42 U.S.C. ???¿ ENHANCED SUPPORT TO ASSIST HEALTH DE- PARTMENTS IN ADDRESSING VECTOR-BORNE DISEASES.
p.001647: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may enter
p.001647: into co- operative agreements with health departments of States, political subdivisions of States, and
p.001647: Indian Tribes and Tribal organizations in areas at high risk of vector-borne diseases in order to
p.001647: increase capacity to identify, report, prevent, and respond to such diseases and related outbreaks.
p.001647: (b) ELIGIBILITY.—To be eligible to enter into a cooperative agreement under this section, an entity described
p.001647: in subsection (a) shall prepare and submit to the Secretary an application at such
p.001647: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001647:
p.001647:
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p.001647:
p.001647: Sec. 2901 PUBLIC HEALTH SERVICE ACT 1648
p.001647:
p.001647: time, in such manner, and containing such information as the Sec- retary may require, including a plan that describes—
p.001647: (1) how the applicant proposes to develop or expand pro- grams to address vector-borne disease
p.001647: risks, including through—
p.001647: (A) related training and workforce development;
p.001647: (B) programmatic efforts to improve capacity to iden- tify, report, prevent, and respond to such disease
p.001647: and re- lated outbreaks; and
p.001647: (C) other relevant activities identified by the Director of the Centers for Disease Control and
p.001647: Prevention, as ap- propriate;
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p.001692: (6) Notification of eligibility, recertification, and other needed communication regarding eligibility,
p.001692: which may include communication via email and cellular phones.
p.001692: (7) Other functionalities necessary to provide eligibles with streamlined enrollment process.
p.001692: (c) APPROVAL AND NOTIFICATION.—With respect to any stand- ard or protocol developed under subsection
p.001692: (a) that has been ap- proved by the HIT Advisory Committee, the Secretary—
p.001692: (1) shall notify States of such standards or protocols; and
p.001692: (2) may require, as a condition of receiving Federal funds for the health information technology investments,
p.001692: that States or other entities incorporate such standards and protocols into such investments.
p.001692: (d) GRANTS FOR IMPLEMENTATION OF APPROPRIATE ENROLL-
p.001692: MENT HIT.—
p.001692: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001692:
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p.001692:
p.001693: 1693
p.001693: PUBLIC HEALTH SERVICE ACT
p.001693: Sec. 3022
p.001693:
p.001693: (1) IN GENERAL.—The Secretary shall award grant to eligi- ble entities to develop new, and adapt existing, technology
p.001693: sys- tems to implement the HIT enrollment standards and protocols developed under subsection (a) (referred to in
p.001693: this subsection as ‘‘appropriate HIT technology’’).
p.001693: (2) ELIGIBLE ENTITIES.—To be eligible for a grant under this subsection, an entity shall—
p.001693: (A) be a State, political subdivision of a State, or a local governmental entity; and
p.001693: (B) submit to the Secretary an application at such time, in such manner, and containing—
p.001693: (i) a plan to adopt and implement appropriate en- rollment technology that includes—
p.001693: (I) proposed reduction in maintenance costs of technology systems;
p.001693: (II) elimination or updating of legacy systems;
p.001693: and
p.001693: (III) demonstrated collaboration with other
p.001693: entities that may receive a grant under this sec- tion that are located in the same State, political
p.001693: subdivision, or locality;
p.001693: (ii) an assurance that the entity will share such appropriate enrollment technology in accordance with
p.001693: paragraph (4); and
p.001693: (iii) such other information as the Secretary may require.
p.001693: (3) SHARING.—
p.001693: (A) IN GENERAL.—The Secretary shall ensure that ap- propriate enrollment HIT adopted under grants under this
p.001693: subsection is made available to other qualified State, qualified political subdivisions of a State,
p.001693: or other appro- priate qualified entities (as described in subparagraph (B)) at no cost.
p.001693: (B) QUALIFIED ENTITIES.—The Secretary shall deter- mine what entities are qualified to receive enrollment HIT
p.001693: under subparagraph (A), taking into consideration the rec- ommendations of the HIT Advisory Committee.
p.001693: SEC. 3022. ø300jj–52¿ INFORMATION BLOCKING.
p.001693: (a) DEFINITION.—
p.001693: (1) IN GENERAL.—In this section, the term ‘‘information blocking’’ means a practice that—
p.001693: (A) except as required by law or specified by the Sec- retary pursuant to rulemaking under paragraph
p.001693: (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic
p.001693: health information; and
p.001693:
p.001693:
p.001693:
p.001693:
p.001693:
p.001693:
p.001693: January 30, 2020
p.001693: (B)(i) if conducted by a health information technology developer, exchange, or network, such developer,
p.001693: exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or
p.001693: materially discourage the access, exchange, or use of electronic health informa- tion; or
p.001693: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001693:
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p.001693: Sec. 3022 PUBLIC HEALTH SERVICE ACT 1694
p.001693:
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p.001719: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001719:
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p.001719:
p.001719:
p.001721: 1721
p.001721: PUBLIC HEALTH SERVICE ACT
p.001721: Sec. 3312
p.001721:
p.001721: subparagraph (D), publish in the Federal Register a pro- posed rule with respect to such recommendation
p.001721: or a de- termination not to propose such a proposed rule and the basis for such determination.
p.001721: (D) PUBLICATION.—The WTC Program Administrator shall, with respect to any proposed rule under this para-
p.001721: graph—
p.001721: (i) publish such proposed rule in accordance with section 553 of title 5, United States Code; and
p.001721: (ii) provide interested parties a period of 30 days after such publication to submit written comments on
p.001721: the proposed rule.
p.001721: The WTC Program Administrator may extend the period described in clause (ii) upon a finding of good cause. In
p.001721: the case of such an extension, the Administrator shall publish such extension in the Federal Register.
p.001721: (E) INTERESTED PARTY DEFINED.—For purposes of this paragraph, the term ‘‘interested party’’ includes a
p.001721: rep- resentative of any organization representing WTC respond- ers, a nationally recognized medical association, a
p.001721: Clinical or Data Center, a State or political subdivision, or any other interested person.
p.001721: (F) INDEPENDENT PEER REVIEWS.—Prior to issuing a final rule to add a health condition to the list in paragraph
p.001721: (3), the WTC Program Administrator shall provide for an independent peer review of the scientific and technical
p.001721: evi- dence that would be the basis for issuing such final rule.
p.001721: (G) ADDITIONAL ADVISORY COMMITTEE RECOMMENDA- TIONS.—
p.001721:
p.001721:
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p.001721:
p.001721:
p.001721: January 30, 2020
p.001721: (i) PROGRAM POLICIES.—
p.001721: (I) EXISTING POLICIES.—Not later than 1 year after the date of enactment of the James Zadroga 9/11 Health and
p.001721: Compensation Reauthorization Act, the WTC Program Administrator shall re- quest the Advisory Committee
p.001721: to review and evaluate the policies and procedures, in effect at the time of the review and
p.001721: evaluation, that are used to determine whether sufficient evidence ex- ists to support adding a health
p.001721: condition to the list in paragraph (3).
p.001721: (II) SUBSEQUENT POLICIES.—Prior to estab- lishing any substantive new policy or procedure used to make
p.001721: the determination described in sub- clause (I) or prior to making any substantive amendment to any
p.001721: policy or procedure described in such subclause, the WTC Program Adminis- trator shall request the Advisory
p.001721: Committee to re- view and evaluate such substantive policy, proce- dure, or amendment.
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p.000017: performance of their official duties; reimbursing officers and employees, subject to regulations of the
p.000017: Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients
p.000017: while such officers or employees are engaged in the performance of their official duties; and maintenance of
p.000017: buildings of the National Institutes of Health.
p.000017: UNAUTHORIZED WEARING OF UNIFORMS
p.000017: SEC. 238. ø238g¿ Except as may be authorized by regulations of the President, the insignia and uniform of
p.000017: commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia
p.000017: or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of
p.000017: such regulations, by any person other than a commissioned officer of the Service.
p.000017: BIANNUAL REPORT
p.000017: SEC. 239. ø238h¿ The Surgeon General shall transmit to the Secretary, for submission to the Congress, on
p.000017: January 1, 1995, and on January 1, every 2 years thereafter, a full report of the adminis- tration of the functions
p.000017: of the Service under this Act, including a detailed statement of receipts and disbursements.
p.000017: MEMORIALS AND OTHER ACKNOWLEDGMENTS
p.000017: SEC. 240. ø238i¿ The Secretary may provide for suitably ac- knowledging, within the Department (whether
p.000017: by memorials, des- ignations, or other suitable acknowledgments), (1) efforts of persons who have contributed
p.000017: substantially to the health of the Nation and
p.000017: (2) gifts for use in activities of the Department related to health.
p.000017:
p.000017:
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p.000017: January 30, 2020
p.000017:
p.000017: EVALUATION OF PROGRAMS
p.000017: SEC. 241. ø238j¿ (a) IN GENERAL.—Such portion as the Sec- retary shall determine, but not less than 0.2
p.000017: percent nor more than
p.000017: 1 percent, of any amounts appropriated for programs authorized under this Act shall be made available for the
p.000017: evaluation (directly, or by grants of contracts) of the implementation and effectiveness of such programs.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 53 PUBLIC HEALTH SERVICE ACT Sec. 243
p.000017:
p.000017: (b) REPORT ON EVALUATIONS.—Not later than February 1 of each year, the Secretary shall prepare and
p.000017: submit to the Com- mittee on Labor and Human Resources of the Senate and the Com- mittee on Energy and Commerce
p.000017: of the House of Representatives a report summarizing the findings of the evaluations conducted under
p.000017: subsection (a).
p.000017: CONTRACT AUTHORITY
p.000017: SEC. 242. ø238k¿ The authority of the Secretary to enter into contracts under this Act shall be
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p.000017: qualifications.
p.000017: (4) Acquire, construct, improve, repair, operate, and main- tain laboratory, research, and other necessary
p.000017: facilities and equipment, and such other real or personal property (including patents) as the Secretary deems
p.000017: necessary; and acquire, with- out regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise,
p.000017: through the Administrator of General Services, buildings or parts of buildings in the District of
p.000017: Columbia or communities located adjacent to the District of Columbia.
p.000017:
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p.000017: January 30, 2020
p.000017: 1 Former section 303 was repealed by section 3201(b)(1) of Public Law 106–310 (114 Stat. 1190).
p.000017: 2 See footnote for section 306.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 79 PUBLIC HEALTH SERVICE ACT Sec. 306
p.000017:
p.000017: (c)(1) The Secretary shall coordinate all health services re- search, evaluations, and demonstrations, all
p.000017: health statistical and epidemiological activities, and all research, evaluations, and dem- onstrations
p.000017: respecting the assessment of health care technology un- dertaken and supported through units of the Department of
p.000017: Health and Human Services. To the maximum extent feasible such coordi- nation shall be carried out through the Agency
p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
p.000017: statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and
p.000017: demonstrations respecting the assessment of health care technology authorized by this Act through the Agency
p.000017: for Health Care Policy and Research and the National Center for Health Sta- tistics.
p.000017:
p.000017: NATIONAL CENTER FOR HEALTH STATISTICS
p.000017: SEC. 306. 3 ø242k¿ (a) There is established in the Department of Health and Human Services the National Center
p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
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p.000017: 87 PUBLIC HEALTH SERVICE ACT Sec. 308
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p.000017: January 30, 2020
p.000017: GENERAL PROVISIONS RESPECTING EFFECTIVENESS, EFFICIENCY, AND QUALITY OF HEALTH SERVICES
p.000017: SEC. 308. ø242m¿ (a)(1) Not later than March 15 of each year, the Secretary shall submit to the President and
p.000017: Congress the fol- lowing reports:
p.000017: (A) A report on health care costs and financing. Such re- port shall include a description and analysis
p.000017: of the statistics collected under section 306(b)(1)(G).
p.000017: (B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the
p.000017: statis- tics collected under section 306(b)(1)(E).
p.000017: (C) A report on the utilization of health resources. Such re- port shall include a description and analysis, by
p.000017: age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(F).
p.000017: (D) A report on the health of the Nation’s people. Such re- port shall include a description and analysis, by
p.000017: age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(A).
p.000017: (2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics.
p.000017: (3) The Office of Management and Budget may review any re- port required by paragraph (1) of this subsection before its
p.000017: submis- sion to Congress, but the Office may not revise any such report or delay its submission beyond the date
p.000017: prescribed for its submission, and may submit to Congress its comments respecting any such re- port.
p.000017: (b)(1) No grant or contract may be made under section 304, 306, or 307 unless an application therefor
p.000017: has been submitted to the Secretary in such form and manner, and containing such infor- mation, as the Secretary may
p.000017: by regulation prescribe and unless a peer review group referred to in paragraph (2) has recommended the
p.000017: application for approval.
p.000017: (2)(A) Each application submitted for a grant or contract under section 306 in an amount exceeding $50,000 of direct
p.000017: costs and for a health services research, evaluation, or demonstration project, or for a grant under section
p.000017: 306(m), shall be submitted to a peer re- view group for an evaluation of the technical and scientific
p.000017: merits of the proposals made in each such application. The Director of the National Center for Health Statistics
p.000017: shall establish such peer re- view groups as may be necessary to provide for such an evaluation of each such
p.000017: application.
p.000017: (B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report
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p.000017: the State and the area for health care facilities, equipment, and services without duplication and otherwise in
p.000017: the most efficient and economical manner.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 315 PUBLIC HEALTH SERVICE ACT 98
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p.000017: January 30, 2020
p.000017:
p.000017: Project Grants for Training, Studies, and Demonstrations
p.000017: (c) The Secretary is also authorized, during the period begin- ning July 1, 1966, and ending June 30, 1974, to
p.000017: make grants to any public or nonprofit private agency, institution, or other organiza- tion to cover all or
p.000017: any part of the cost of projects for training, studies, or demonstrations looking toward the development
p.000017: of im- proved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out
p.000017: this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June
p.000017: 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30,
p.000017: 1969,
p.000017: $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000
p.000017: for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and
p.000017: $4,700,000 for the fiscal year ending June 30, 1974.
p.000017: SEC. 315. ø42 U.S.C. 247¿ ASSISTING VETERANS WITH MILITARY EMER- GENCY MEDICAL TRAINING TO MEET REQUIREMENTS
p.000017: FOR BECOMING CIVILIAN HEALTH CARE PROFES- SIONALS.
p.000017: (a) PROGRAM.—
p.000017: (1) IN GENERAL.—The Secretary may establish a program, in consultation with the Secretary of Labor,
p.000017: consisting of awarding demonstration grants to States to streamline State requirements and procedures in
p.000017: order to assist veterans who held certain military occupational specialties related to medical care or who have
p.000017: completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification,
p.000017: licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni-
p.000017: cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician
p.000017: assistant professions) in the State.
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p.000109: section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease
p.000109: Control and Prevention.
p.000109: (2) GENERAL DUTIES.—The Secretary shall carry out pro- grams—
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p.000109: January 30, 2020
p.000109: (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and
p.000109: disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the
p.000109: causes of such de- fects and disabilities and on the incidence and prevalence of such defects and disabilities;
p.000109: (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention
p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000109:
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p.000111: PUBLIC HEALTH SERVICE ACT
p.000111: Sec. 317C
p.000111:
p.000111: (C) to provide information and education to the public on the prevention of such defects and disabilities;
p.000111: (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary
p.000111: health conditions among individuals with disabilities; and
p.000111: (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common
p.000111: permanently disabling birth defect.
p.000111: (3) FOLIC ACID.—The Secretary shall carry out section 317J through the Center.
p.000111: (4) CERTAIN PROGRAMS.—
p.000111: (A) TRANSFERS.—All programs and functions described in subparagraph (B) are transferred to the Center, effec-
p.000111: tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health
p.000111: Act of 2000 10.
p.000111: (B) RELEVANT PROGRAMS.—The programs and func- tions described in this subparagraph are all programs and functions
p.000111: that—
p.000111: (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn
p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
p.000111: sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the
p.000111: Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act
p.000111: referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of
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p.000119: directly or through do- nations from public or private entities and may be in cash or in kind, including equipment or
p.000119: services.
p.000119: (B) FEDERAL AMOUNTS NOT TO BE INCLUDED AS CON- TRIBUTIONS.—Amounts provided by the Federal Govern- ment,
p.000119: or services assisted or subsidized to any significant extent by the Federal Government, may not be included in
p.000119: determining the amount of non-Federal contributions as described in subparagraph (A).
p.000119: (e) SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
p.000119: (1) IN GENERAL.—Upon the request of a grantee under sub- section (a) or (b), the Secretary may, subject to
p.000119: paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out
p.000119: the subsection involved and, for such purpose, may detail to the State any officer or em- ployee of the
p.000119: Department of Health and Human Services.
p.000119: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.000119: Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing
p.000119: personnel and the fair market value of any supplies, equipment, or services pro- vided by the Secretary.
p.000119: The Secretary shall, for the payment of expenses incurred in complying with such request, expend the
p.000119: amounts withheld.
p.000119: (f) ADVISORY COUNCIL.—
p.000119: (1) IN GENERAL.—The Secretary shall establish an advisory council to be known as the Advisory Council for the
p.000119: Elimi- nation of Tuberculosis (in this subsection referred to as the ‘‘Council’’).
p.000119: (2) DUTIES.—The Council shall provide advice and rec- ommendations regarding the elimination of tuberculosis to
p.000119: the Secretary. In addition, the Council shall, with respect to elimi- nating such disease, provide to the Secretary and
p.000119: other appro- priate Federal officials advice on—
p.000119: (A) coordinating the activities of the Department of Health and Human Services and other Federal agencies
p.000119: that relate to the disease, including activities under sub- section (b);
p.000119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000119: Sec. 317E PUBLIC HEALTH SERVICE ACT 120
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p.000119: (B) responding rapidly and effectively to emerging issues in tuberculosis; and
p.000119: (C) efficiently utilizing the Federal resources involved.
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p.000121: PUBLIC HEALTH SERVICE ACT
p.000121: Sec. 317E
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p.000121: January 30, 2020
p.000121: (5) COMPOSITION.—The Council shall be composed of—
p.000121: (A) ex officio representatives from the Centers for Dis- ease Control and Prevention, the National Institutes of
p.000121: Health, the United States Agency for International Devel- opment, the Agency for Healthcare Research and
p.000121: Quality, the Health Resources and Services Administration, the United States-Mexico Border Health
p.000121: Commission, and other Federal departments and agencies that carry out sig- nificant activities related to
p.000121: tuberculosis;
p.000121: (B) State and local tuberculosis control and public health officials;
p.000121: (C) individuals who are scientists, physicians, laboratorians, and other health professionals
p.000121: who rep- resent disciplines relevant to tuberculosis elimination; and
p.000121: (D) members of national and international nongovern- mental organizations established to address the elimi-
p.000121: nation of tuberculosis.
p.000121: (6) STAFF, INFORMATION, AND OTHER ASSISTANCE.—The Secretary shall provide to the Council such staff,
p.000121: information, and other assistance as may be necessary to carry out the du- ties of the Council.
p.000121: (g) FEDERAL TUBERCULOSIS TASK FORCE.—
p.000121: (1) DUTIES.—The Federal Tuberculosis Task Force (in this subsection referred to as the ‘‘Task Force’’) shall provide to
p.000121: the Secretary and other appropriate Federal officials advice on re- search into new tools under subsection (b)(2),
p.000121: including advice regarding the efficient utilization of the Federal resources in- volved.
p.000121: (2) COMPREHENSIVE PLAN FOR NEW TOOLS DEVELOPMENT.— In carrying out paragraph (1), the Task Force shall
p.000121: make rec- ommendations on the development of a comprehensive plan for the creation of new tools for the elimination of
p.000121: tuberculosis, in- cluding drugs, diagnostics, and vaccines.
p.000121: (3) CONSULTATION.—In developing the comprehensive plan under paragraph (1), the Task Force shall consult with
p.000121: exter- nal parties including representatives from groups such as—
p.000121: (A) scientists, physicians, laboratorians, and other health professionals who represent the specialties and
p.000121: dis- ciplines relevant to the research under consideration;
p.000121: (B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities
p.000121: rel- evant to research under consideration;
p.000121: (C) members of national and international nongovern- mental organizations established to address tuberculosis
p.000121: elimination;
p.000121: (D) members from the general public who are knowl- edgeable with respect to tuberculosis including individuals
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p.000209: below, may) include the following terms:
p.000209: (I) PAYMENT CONDITIONED ON DELIVERY.—The contract shall provide that no payment may be made until delivery of
p.000209: a portion, acceptable to the Secretary, of the total number of units contracted for, except that, notwithstanding
p.000209: any other provi- sion of law, the contract may provide that, if the Secretary determines (in the
p.000209: Secretary’s discre- tion) that an advance payment, partial payment for significant milestones, or payment
p.000209: to increase manufacturing capacity is necessary to ensure success of a project, the Secretary shall
p.000209: pay an amount, not to exceed 10 percent of the contract amount, in advance of delivery. The
p.000209: Secretary shall, to the extent practicable, make the deter- mination of advance payment at the same time as the
p.000209: issuance of a solicitation. The contract shall provide that such advance payment is required to be repaid if
p.000209: there is a failure to perform by the vendor under the contract. The contract may also provide for
p.000209: additional advance payments of 5 per- cent each for meeting the milestones specified in such contract, except
p.000209: that such payments shall not exceed 50 percent of the total contract amount. If the specified milestones are reached,
p.000209: the advanced payments of 5 percent shall not be required to be repaid. Nothing in this subclause shall be con-
p.000209: strued as affecting the rights of vendors under provisions of law or regulation (including the Fed- eral
p.000209: Acquisition Regulation) relating to the termi- nation of contracts for the convenience of the Gov- ernment.
p.000209: (II) DISCOUNTED PAYMENT.—The contract may
p.000209: provide for a discounted price per unit of a prod- uct that is not licensed, cleared, or approved as
p.000209: described in paragraph (1)(B)(i)(III)(aa) at the time of delivery, and may provide for payment of an
p.000209: additional amount per unit if the product be- comes so licensed, cleared, or approved before the expiration date
p.000209: of the contract (including an addi- tional amount per unit of product delivered before the effective date of such
p.000209: licensing, clearance, or approval).
p.000209: (III) CONTRACT DURATION.—The contract shall be for a period not to exceed five years, except that, in
p.000209: first awarding the contract, the Secretary may provide for a longer duration, not exceeding
p.000209: 10 years, if the Secretary determines that com- plexities or other difficulties in performance under
p.000209: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000209:
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p.000211: PUBLIC HEALTH SERVICE ACT
p.000211: Sec. 319F–2
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p.000249: covered activities) of a product, process, or service if such information is not reasonably necessary to
p.000249: carry out such covered activities.
p.000249: (v) Entering into any agreement or engaging in any other conduct restricting, requiring, or otherwise
p.000249: involving the production of a product, process, or serv- ice that is not expressly exempted from the antitrust
p.000249: laws under subsection (a)(4).
p.000249: (vi) Except as otherwise provided in this sub- section, entering into any agreement or engaging in
p.000249: any other conduct to restrict or require participation by any person participating in such covered activities,
p.000249: in any unilateral or joint activity that is not reason- ably necessary to carry out such covered activities.
p.000249: (vii) Entering into any agreement or engaging in any other conduct restricting or setting the price at
p.000249: which a countermeasure or product is offered for sale, whether by bid or otherwise.
p.000249: SEC. 319M. ø247d–f¿ NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING GROUPS.
p.000249: (a) IN GENERAL.—
p.000249: (1) ESTABLISHMENT AND FUNCTION.—The Secretary shall establish the National Biodefense Science Board (referred to
p.000249: in this section as the ‘‘Board’’) to provide expert advice and guid- ance to the Secretary on scientific, technical and
p.000249: other matters of special interest to the Department of Health and Human Services regarding current and future
p.000249: chemical, biological, nu- clear, and radiological agents, whether naturally occurring, ac- cidental, or deliberate.
p.000249: (2) MEMBERSHIP.—The membership of the Board shall be comprised of individuals who represent the
p.000249: Nation’s pre- eminent scientific, public health, and medical experts, as fol- lows—
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p.000249: January 30, 2020
p.000249: (A) such Federal officials as the Secretary may deter- mine are necessary to support the functions of
p.000249: the Board;
p.000249: (B) four individuals representing the pharmaceutical, biotechnology, and device industries;
p.000249: (C) four individuals representing academia; and
p.000249: (D) five other members as determined appropriate by the Secretary, of whom—
p.000249: (i) one such member shall be a practicing healthcare professional;
p.000249: (ii) one such member shall be an individual from an organization representing healthcare consumers;
p.000249: (iii) one such member shall be an individual with pediatric subject matter expertise; and
p.000249: (iv) one such member shall be a State, tribal, ter- ritorial, or local public health official.
p.000249: Nothing in this paragraph shall preclude a member of the Board from satisfying two or more of the
p.000249: requirements de- scribed in subparagraph (D).
p.000249: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000251: PUBLIC HEALTH SERVICE ACT
p.000251: Sec. 319M
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p.000355: historically black health professions schools and such providers, whose goal is to improve the health status of
p.000355: medically underserved popu- lations; or
p.000355: (3) supporting the research-related costs of patient care, data collection, and academic training resulting
p.000355: from such af- filiations.
p.000355: (k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000355: sums as may be necessary for each of fiscal years 2002 through 2006.
p.000355: (l) DATE CERTAIN FOR TERMINATION OF PROGRAM.—Funds may not be appropriated to carry out this section after
p.000355: September 30, 2006.
p.000355: SEC. 340A. ø256a¿ PATIENT NAVIGATOR GRANTS.
p.000355: (a) GRANTS.—The Secretary, acting through the Administrator of the Health Resources and Services
p.000355: Administration, may make grants to eligible entities for the development and operation of demonstration
p.000355: programs to provide patient navigator services to improve health care outcomes. The Secretary shall coordinate
p.000355: with, and ensure the participation of, the Indian Health Service, the Na- tional Cancer Institute, the Office of Rural
p.000355: Health Policy, and such other offices and agencies as deemed appropriate by the Secretary, regarding the design and
p.000355: evaluation of the demonstration pro- grams.
p.000355: (b) USE OF FUNDS.—The Secretary shall require each recipient of a grant under this section to use the grant
p.000355: to recruit, assign, train, and employ patient navigators who have direct knowledge of the communities they serve to
p.000355: facilitate the care of individuals, in- cluding by performing each of the following duties:
p.000355: (1) Acting as contacts, including by assisting in the coordi- nation of health care services and provider
p.000355: referrals, for indi- viduals who are seeking prevention or early detection services for, or who following a
p.000355: screening or early detection service are found to have a symptom, abnormal finding, or diagnosis of, cancer or
p.000355: other chronic disease.
p.000355: (2) Facilitating the involvement of community organiza- tions in assisting individuals who are at risk
p.000355: for or who have
p.000355: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000357: PUBLIC HEALTH SERVICE ACT
p.000357: Sec. 340A
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p.000357: cancer or other chronic diseases to receive better access to high-quality health care services (such as by
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p.000363: (A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improve-
p.000363: ments in compliance by manufacturers with the require- ments of this section in order to prevent
p.000363: overcharges and other violations of the discounted pricing requirements specified in this section.
p.000363: (B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:
p.000363: (i) The development of a system to enable the Sec- retary to verify the accuracy of ceiling prices cal-
p.000363: culated by manufacturers under subsection (a)(1) and charged to covered entities, which shall include the
p.000363: following:
p.000363: (I) Developing and publishing through an ap- propriate policy or regulatory issuance, precisely defined
p.000363: standards and methodology for the cal- culation of ceiling prices under such subsection.
p.000363: (II) Comparing regularly the ceiling prices cal- culated by the Secretary with the quarterly pric- ing data that
p.000363: is reported by manufacturers to the Secretary.
p.000363: (III) Performing spot checks of sales trans- actions by covered entities.
p.000363: (IV) Inquiring into the cause of any pricing discrepancies that may be identified and either taking, or
p.000363: requiring manufacturers to take, such corrective action as is appropriate in response to such price
p.000363: discrepancies.
p.000363: (ii) The establishment of procedures for manufac- turers to issue refunds to covered entities in the event that
p.000363: there is an overcharge by the manufacturers, in- cluding the following:
p.000363: (I) Providing the Secretary with an expla- nation of why and how the overcharge occurred,
p.000363:
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p.000363: January 30, 2020
p.000363: 49 There are no references to the term ‘‘covered drug’’ in this section.
p.000363: 50 In law, there is no subsection (c) in section 340B of the Public Health Service Act. Sub- section
p.000363: (d) of section 340B of the Public Health Service, as in effect before the enactment of Pub- lic Law 111–148, was
p.000363: redesignated as subsection (c) by section 2501(f)(1)(C) of Public Law 111– 148, amended to read by section 7101(d) of
p.000363: Public Law 111–148, and stricken by section 2302(2) of Public Law 111–152. Subsection (d) of section 340B of the Public
p.000363: Health Service, as currently in effect, is shown according to the probable intent of the Congress. Section
p.000363: 7102(a) of Public Law 111–148 does not execute because it amends to read a nonexistent subsection (d). Notably,
p.000363: section 2302(3) of Public Law 111–152 assumes that section 7102(a) of Public Law 111–148 exe- cuted properly and makes
p.000363: amendments to subsection (d).
p.000363: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000365: PUBLIC HEALTH SERVICE ACT
p.000365: Sec. 340B
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p.000449: (B) have a board of directors—
p.000449: (i) that includes representatives of organ procurement organizations (including organizations that have received
p.000449: grants under section 371), transplant centers, voluntary health associations, and the general public; and
p.000449: (ii) that shall establish an executive committee and other committees, whose chairpersons shall be
p.000449: selected to ensure continuity of leadership for the board.
p.000449: (2) The Organ Procurement and Transplantation Network shall—
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p.000449: (A) establish in one location or through regional centers—
p.000449: (i) a national list of individuals who need organs, and
p.000449: (ii) a national system, through the use of computers and in accordance with established medical criteria,
p.000449: to match organs and individuals included in the list, espe- cially individuals whose immune system makes it
p.000449: difficult for them to receive organs,
p.000449: (B) establish membership criteria and medical criteria for allocating organs and provide to members of the
p.000449: public an op- portunity to comment with respect to such criteria,
p.000449: (C) maintain a twenty-four-hour telephone service to facili- tate matching organs with individuals included in the
p.000449: list,
p.000449: (D) assist organ procurement organizations in the nation- wide distribution of organs equitably among
p.000449: transplant pa- tients,
p.000449: (E) adopt and use standards of quality for the acquisition and transportation of donated organs,
p.000449: (F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions or on a
p.000449: national basis), samples of blood sera from individuals who are included on the list and whose immune system
p.000449: makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such
p.000449: individuals with organ donors,
p.000449: (G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant
p.000449: centers,
p.000449: (H) provide information to physicians and other health professionals regarding organ donation,
p.000449: (I) collect, analyze, and publish data concerning organ do- nation and transplants,
p.000449: (J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement
p.000449: and al- location,
p.000449: (K) work actively to increase the supply of donated organs,
p.000449: (L) submit to the Secretary an annual report containing in- formation on the comparative costs and patient
p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
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p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
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p.000451:
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p.000451: January 30, 2020
p.000451: 82 Clauses (i) and (ii) probably should be redesignated as subparagraphs (A) and (B). See sec- tion 204(b)(2) of Public
p.000451: Law 101–616 (104 Stat. 3285).
p.000451: 83 So in law. There probably should be a comma after ‘‘Senate’’ rather than a period. See sec- tion 205 of Public Law
p.000451: 101–616.
p.000451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000453: PUBLIC HEALTH SERVICE ACT
p.000453: Sec. 377A
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p.000453: (1) the term ‘‘donating individuals’’ as including individ- uals who in good faith incur qualifying expenses
p.000453: toward the in- tended donation of an organ but with respect to whom, for such reasons as the Secretary determines
p.000453: to be appropriate, no do- nation of the organ occurs; and
p.000453: (2) the term ‘‘qualifying expenses’’ as including the ex- penses of having relatives or other
p.000453: individuals, not to exceed 2, accompany or assist the donating individual for purposes of subsection (a) (subject to
p.000453: making payment for only those types of expenses that are paid for a donating individual).
p.000453: (d) RELATIONSHIP TO PAYMENTS UNDER OTHER PROGRAMS.—An award may be made under subsection (a) only if the
p.000453: applicant in- volved agrees that the award will not be expended to pay the quali- fying expenses of a donating
p.000453: individual to the extent that payment has been made, or can reasonably be expected to be made, with re- spect to such
p.000453: expenses—
p.000453: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000453: health benefits program;
p.000453: (2) by an entity that provides health services on a prepaid basis; or
p.000453: (3) by the recipient of the organ.
p.000453: (e) DEFINITIONS.—For purposes of this section:
p.000453: (1) The term ‘‘donating individuals’’ has the meaning indi- cated for such term in subsection (a)(1), subject
p.000453: to subsection (c)(1).
p.000453: (2) The term ‘‘qualifying expenses’’ means the expenses au- thorized for purposes of subsection (a), subject to
p.000453: subsection (c)(2).
p.000453: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000453: to be appropriated
p.000453: $5,000,000 for each of the fiscal years 2005 through 2009.
p.000453: SEC. 377A. ø274f–1¿ PUBLIC AWARENESS; STUDIES AND DEMONSTRA- TIONS.
p.000453: (a) ORGAN DONATION PUBLIC AWARENESS PROGRAM.—The Sec- retary shall, directly or through grants or contracts,
p.000453: establish a public education program in cooperation with existing national public awareness campaigns to
p.000453: increase awareness about organ do- nation and the need to provide for an adequate rate of such dona- tions.
p.000453: (b) STUDIES AND DEMONSTRATIONS.—The Secretary may make peer-reviewed grants to, or enter into peer-reviewed
p.000453: contracts with, public and nonprofit private entities for the purpose of carrying out studies and demonstration
p.000453: projects to increase organ donation and recovery rates, including living donation.
p.000453: (c) GRANTS TO STATES.—
p.000453: (1) IN GENERAL.—The Secretary may make grants to States for the purpose of assisting States in carrying
p.000453: out organ donor awareness, public education, and outreach activities and programs designed to increase the number
p.000453: of organ donors within the State, including living donors.
p.000453: (2) ELIGIBILITY.—To be eligible to receive a grant under this subsection, a State shall—
p.000453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499:
p.000499: January 30, 2020
p.000499:
p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
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p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
...

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p.000553: January 30, 2020
p.000553:
p.000553: areas, including new or improved techniques to assess the health effects of interventions, including health
p.000553: impact assess- ment and population health modeling;
p.000553: (3) improved integration with Federal Government health objectives and related target setting for health
p.000553: improvement;
p.000553: (4) the enhanced dissemination of recommendations;
p.000553: (5) the provision of technical assistance to those health care professionals, agencies, and organizations
p.000553: that request help in implementing the Guide recommendations; and
p.000553: (6) providing yearly reports to Congress and related agen- cies identifying gaps in research and recommending
p.000553: priority areas that deserve further examination, including areas re- lated to populations and age groups
p.000553: not adequately addressed by current recommendations.
p.000553: (c) ROLE OF AGENCY.—The Director shall provide ongoing ad- ministrative, research, and technical support
p.000553: for the operations of the Task Force, including coordinating and supporting the dissemi- nation of the
p.000553: recommendations of the Task Force, ensuring ade- quate staff resources, and assistance to those
p.000553: organizations re- questing it for implementation of Guide recommendations.
p.000553: (d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE.— The Task Force shall take appropriate steps to coordinate
p.000553: its work with the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices,
p.000553: including the examination of how each task force’s recommendations interact at the nexus of clinic and
p.000553: community.
p.000553: (e) OPERATION.—In carrying out the duties under subsection (b), the Task Force shall not be subject to the
p.000553: provisions of Appen- dix 2 of title 5, United States Code.
p.000553: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary
p.000553: for each fiscal year to carry out the activities of the Task Force.
p.000553: SEC. 399V. ø280g–11¿ GRANTS TO PROMOTE POSITIVE HEALTH BEHAV- IORS AND OUTCOMES.
p.000553: (a) GRANTS AUTHORIZED.—The Director of the Centers for Dis- ease Control and Prevention, in collaboration with
p.000553: the Secretary, shall award grants to eligible entities to promote positive health behaviors and outcomes
p.000553: for populations in medically underserved communities through the use of community health workers.
p.000553: (b) USE OF FUNDS.—Grants awarded under subsection (a) shall be used to support community health workers—
p.000553: (1) to educate, guide, and provide outreach in a community setting regarding health problems prevalent in
p.000553: medically un- derserved communities, particularly racial and ethnic minority populations;
...

p.000629: collaboration across the institutes and centers, to leverage scientific opportunity, and to advance
p.000629: biomedicine.
p.000629: (2) REQUIREMENTS.—The strategy under paragraph (1) shall—
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p.000629:
p.000629:
p.000629: January 30, 2020
p.000629: (A) identify strategic research priorities and objectives across biomedical research, including—
p.000629: (i) an assessment of the state of biomedical and behavioral research, including areas of opportunity
p.000629: with respect to basic, clinical, and translational re- search;
p.000629: (ii) priorities and objectives to advance the treat- ment, cure, and prevention of health conditions;
p.000629: (iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and
p.000629: (iv) the identification of near-, mid-, and long-term scientific needs;
p.000629: (B) consider, in carrying out subparagraph (A)—
p.000629: (i) disease burden in the United States and the potential for return on investment to the United
p.000629: States;
p.000629: (ii) rare diseases and conditions;
p.000629: (iii) biological, social, and other determinants of health that contribute to health disparities; and
p.000629: (iv) other factors the Director of National Insti- tutes of Health determines appropriate;
p.000629: (C) include multi-institute priorities, including coordi- nation of research among institutes and centers;
p.000629: (D) include strategic priorities for funding research through the Common Fund, in accordance with section
p.000629: 402A(c)(1)(C);
p.000629: (E) address the National Institutes of Health’s pro- posed and ongoing activities related to training and
p.000629: the biomedical workforce; and
p.000629: (F) describe opportunities for collaboration with other agencies and departments, as appropriate.
p.000629: (3) USE OF PLANS.—Strategic plans developed and updated by the national research institutes and national centers of the
p.000629: National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed
p.000629: by the stra- tegic plans developed and updated under this subsection. Such plans developed by and updated by the
p.000629: national research insti- tutes and national centers shall have a common template.
p.000629: (4) CONSULTATION.—The Director of National Institutes of Health shall develop the strategic plan under paragraph
p.000629: (1) in
p.000629: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000631: PUBLIC HEALTH SERVICE ACT
p.000631: Sec. 402A
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p.000737: PURPOSE OF THE INSTITUTE
p.000737:
p.000737: SEC. 457. ø285j¿ The general purpose of the National Institute of Neurological Disorders and Stroke (hereafter in this
p.000737: subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of research, training, health information
p.000737: dissemination, and other programs with respect to neurological disease and disorder and stroke.
p.000737: SPINAL CORD REGENERATION RESEARCH
p.000737: SEC. 458. ø285j–1¿ The Director of the Institute shall conduct and support research into spinal cord
p.000737: regeneration.
p.000737: BIOENGINEERING RESEARCH
p.000737: SEC. 459. ø285j–2¿ The Director of the Institute shall make grants or enter into contracts for research
p.000737: on the means to over- come paralysis of the extremities through electrical stimulation and the use of computers.
p.000737:
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p.000737: January 30, 2020
p.000737: RESEARCH ON MULTIPLE SCLEROSIS
p.000737: SEC. 460. ø285j–3¿ The Director of the Institute shall conduct and support research on multiple sclerosis,
p.000737: especially research on effects of genetics and hormonal changes on the progress of the dis- ease.
p.000737: Subpart 11—National Institute of General Medical Sciences
p.000737: SEC. 461. ø285k¿ NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES.
p.000737: (a) GENERAL PURPOSE.—The general purpose of the National Institute of General Medical Sciences is the conduct
p.000737: and support of research, training, and, as appropriate, health information dissemi- nation, and other programs with
p.000737: respect to general or basic medical sciences and related natural or behavioral sciences which have sig- nificance for
p.000737: two or more other national research institutes or are outside the general area of responsibility of any
p.000737: other national re- search institute.
p.000737: (b) INSTITUTIONAL DEVELOPMENT AWARD PROGRAM.—
p.000737: (1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director
p.000737: of the Na- tional Institute of General Medical Sciences, shall establish a program to enhance the
p.000737: competitiveness of such entities in ob- taining funds from the national research institutes for con- ducting
p.000737: biomedical and behavioral research.
p.000737: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000739: 739
p.000739: PUBLIC HEALTH SERVICE ACT
p.000739: Sec. 463A
p.000739:
p.000739: (B) The entities referred to in subparagraph (A) are enti- ties that conduct biomedical and behavioral
p.000739: research and are located in a State in which the aggregate success rate for ap- plications to the
p.000739: national research institutes for assistance for such research by the entities in the State has historically con-
p.000739: stituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States.
p.000739: (C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in
...

p.000753:
p.000753:
p.000753:
p.000753:
p.000753: January 30, 2020
p.000753: OFFICE OF RURAL MENTAL HEALTH RESEARCH
p.000753: SEC. 464T. ø285p–2¿ (a) IN GENERAL.—There is established within the Institute an office to be known as
p.000753: the Office of Rural
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: Sec. 464U PUBLIC HEALTH SERVICE ACT 754
p.000753:
p.000753: Mental Health Research (hereafter in this section referred to as the ‘‘Office’’). The Office shall be headed by a
p.000753: director, who shall be ap- pointed by the Director of such Institute from among individuals experienced or
p.000753: knowledgeable in the provision of mental health services in rural areas. The Secretary shall carry out
p.000753: the authori- ties established in this section acting through the Director of the Office.
p.000753: (b) COORDINATION OF ACTIVITIES.—The Director of the Office, in consultation with the Director of
p.000753: the Institute and with the Di- rector of the Office of Rural Health Policy, shall—
p.000753: (1) coordinate the research activities of the Department of Health and Human Services as such activities relate
p.000753: to the mental health of residents of rural areas; and
p.000753: (2) coordinate the activities of the Office with similar ac- tivities of public and nonprofit private
p.000753: entities.
p.000753: (c) RESEARCH, DEMONSTRATIONS, EVALUATIONS, AND DISSEMI- NATION.—The Director of the Office may, with respect to
p.000753: the men- tal health of adults and children residing in rural areas—
p.000753: (1) conduct research on conditions that are unique to the residents of rural areas, or more serious or
p.000753: prevalent in such residents;
p.000753: (2) conduct research on improving the delivery of services in such areas; and
p.000753: (3) disseminate information to appropriate public and non- profit private entities.
p.000753: (d) AUTHORITY REGARDING GRANTS AND CONTRACTS.—The Di- rector of the Office may carry out the authorities
p.000753: established in subsection (c) directly and through grants, cooperative agreements, or contracts with public or
p.000753: nonprofit private entities.
p.000753: OFFICE ON AIDS
p.000753: SEC. 464U. ø285p–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000753: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000753: with respect to AIDS research related to—
p.000753: (1) primary prevention of the spread of HIV, including transmission via sexual behavior;
p.000753: (2) mental health services research; and
p.000753: (3) other matters determined appropriate by the Director.
p.000753: Subpart 17—National Institute of Nursing Research
p.000753: PURPOSE OF THE INSTITUTE
p.000753: SEC. 464V. ø285q¿ The general purpose of the National Insti- tute of Nursing Research (in this subpart referred
p.000753: to as the ‘‘Insti- tute’’) is the conduct and support of, and dissemination of informa- tion respecting, basic and
...

p.000783: (f) ENSURING HIGH QUALITY, RIGOROUS SCIENTIFIC REVIEW.— In order to ensure high quality, rigorous
p.000783: scientific review of com- plementary and alternative, diagnostic and prevention modalities,
p.000783: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000785: 785
p.000785: PUBLIC HEALTH SERVICE ACT
p.000785: Sec. 485D
p.000785:
p.000785: disciplines and systems, the Director of the Center shall conduct or support the following activities:
p.000785: (1) Outcomes research and investigations.
p.000785: (2) Epidemiological studies.
p.000785: (3) Health services research.
p.000785: (4) Basic science research.
p.000785: (5) Clinical trials.
p.000785: (6) Other appropriate research and investigational activi-
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p.000785: January 30, 2020
p.000785: ties.
p.000785: The Director of NIH, in coordination with the Director of the Cen- ter, shall designate specific personnel in each
p.000785: Institute to serve as full-time liaisons with the Center in facilitating appropriate coordi- nation and scientific
p.000785: input.
p.000785: (g) DATA SYSTEM; INFORMATION CLEARINGHOUSE.—
p.000785: (1) DATA SYSTEM.—The Director of the Center shall estab- lish a bibliographic system for the collection,
p.000785: storage, and re- trieval of worldwide research relating to complementary and integrative health, diagnostic
p.000785: and prevention modalities, dis- ciplines and systems. Such a system shall be regularly updated and publicly
p.000785: accessible.
p.000785: (2) CLEARINGHOUSE.—The Director of the Center shall es- tablish an information clearinghouse to facilitate and
p.000785: enhance, through the effective dissemination of information, knowledge and understanding of integrative
p.000785: health treatment, diagnostic and prevention practices by health professionals, patients, in- dustry, and the
p.000785: public.
p.000785: (h) RESEARCH CENTERS.—The Director of the Center, after con- sultation with the advisory council for the Center,
p.000785: shall provide support for the development and operation of multipurpose centers to conduct research and other
p.000785: activities described in subsection (a) with respect to complementary and integrative health, diagnostic and
p.000785: prevention modalities, disciplines and systems. The provision of support for the development and operation of
p.000785: such centers shall include accredited complementary and integrative health research and education facilities.
p.000785: (i) AVAILABILITY OF RESOURCES.—After consultation with the Director of the Center, the Director of NIH
p.000785: shall ensure that re- sources of the National Institutes of Health, including laboratory and clinical
p.000785: facilities, fellowships (including research training fel- lowship and junior and senior clinical
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p.000789: January 30, 2020
p.000789:
p.000789: (iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake
p.000789: bio- medical and behavioral research;
p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
p.000789: (C) provide contracts for scholarships and loan repayments in accordance with sections 487D and 487E, subject
p.000789: to pro- viding not more than an aggregate 50 such contracts during the fiscal years 1994 through 1996.
p.000789: A reference in this subsection to the National Institutes of Health shall be considered to include the
p.000789: institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the
p.000789: Administration, 53 as the case may be.
p.000789: (2) Ruth L. Kirschstein National Research Service Awards may not be used to support residency training of
p.000789: physicians and other health professionals.
p.000789: (3) In awarding Ruth L. Kirschstein National Research Service Awards under this section, the Secretary shall take
p.000789: account of the Nation’s overall need for biomedical research personnel by giving special consideration to
p.000789: physicians who agree to undertake a min- imum of two years of biomedical research.
p.000789: (4) The Secretary shall carry out paragraph (1) in a manner that will result in the recruitment of women, and
p.000789: individuals from disadvantaged backgrounds (including racial and ethnic minori- ties), into fields of
p.000789: biomedical or behavioral research and in the provision of research training to women and such individuals.
p.000789: (b)(1) No Ruth L. Kirschstein National Research Service Award may be made by the Secretary to any individual unless—
p.000789: (A) the individual has submitted to the Secretary an appli- cation therefor and the Secretary has approved the
p.000789: application;
p.000789: (B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe,
p.000789: assurances satis- factory to the Secretary that the individual will meet the serv- ice requirement of subsection (c);
p.000789: and
p.000789: (C) in the case of a Ruth L. Kirschstein National Research Service Award for a purpose described in
p.000789: subsection (a)(1)(A)(iii), the individual has been sponsored (in such man- ner as the Secretary may by
p.000789: regulation require) by the institu- tion at which the research or training under the award will be conducted.
p.000789: An application for an award shall be in such form, submitted in such manner, and contain such
p.000789: information, as the Secretary may by regulation prescribe.
...

p.000797: which have significant en- rollments of disadvantaged students. Visiting Scientist Awards shall be made
p.000797: by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of
p.000797: scientists from other institutions for the purpose of receiving guidance, ad- vice, and instruction with
p.000797: regard to research, teaching, and cur- riculum development in the biomedical and behavioral sciences and such
p.000797: other aspects of these sciences as the Secretary shall deem ap- propriate.
p.000797: (b) The amount of each Visiting Scientist Award shall include such sum as shall be commensurate with
p.000797: the salary or remunera- tion which the individual receiving the award would have been en- titled to receive from the
p.000797: institution with which the individual has, or had, a permanent or immediately prior affiliation. Eligibility for and
p.000797: terms of Visiting Scientist Awards shall be determined in ac- cordance with regulations the Secretary shall
p.000797: prescribe.
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p.000797: January 30, 2020
p.000797: STUDIES RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH PERSONNEL
p.000797: SEC. 489. ø288b¿ (a) The Secretary shall, in accordance with subsection (b), arrange for the conduct of
p.000797: a continuing study to—
p.000797: (1) establish (A) the Nation’s overall need for biomedical and behavioral research personnel, (B) the
p.000797: subject areas in which such personnel are needed and the number of such per- sonnel needed in each such area, and (C)
p.000797: the kinds and extent of training which should be provided such personnel;
p.000797: (2) assess (A) current training programs available for the training of biomedical and behavioral research
p.000797: personnel which are conducted under this Act, at or through national research institutes under the National
p.000797: Institutes of Health, and (B) other current training programs available for the training of such
p.000797: personnel;
p.000797: (3) identify the kinds of research positions available to and held by individuals completing such programs;
p.000797: (4) determine, to the extent feasible, whether the programs referred to in clause (B) of paragraph (2) would be
p.000797: adequate to meet the needs established under paragraph (1) if the pro- grams referred to in clause (A)
p.000797: of paragraph (2) were termi- nated; and
p.000797: (5) determine what modifications in the programs referred to in paragraph (2) are required to meet the needs
p.000797: established under paragraph (1).
p.000797: (b)(1) The Secretary shall request the National Academy of Sciences to conduct the study required by
p.000797: subsection (a) under an arrangement under which the actual expenses incurred by such Academy in conducting
p.000797: such study will be paid by the Secretary. If the National Academy of Sciences is willing to do so,
p.000797: the Sec- retary shall enter into such an arrangement with such Academy for the conduct of such study.
p.000797: (2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the
...

p.000813: (g) DEFINITION.—For purposes of this section, the term ‘‘human fetal tissue’’ means tissue or cells obtained from a
p.000813: dead human em- bryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000813:
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p.000813: Sec. 498B PUBLIC HEALTH SERVICE ACT 814
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p.000813: January 30, 2020
p.000813:
p.000813: PROHIBITIONS REGARDING HUMAN FETAL TISSUE
p.000813: SEC. 498B. ø289g–2¿ (a) PURCHASE OF TISSUE.—It shall be un-
p.000813: lawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for
p.000813: valuable consideration if the transfer affects interstate commerce.
p.000813: (b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DO- NATION FOR USE IN TRANSPLANTATION.—It shall
p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
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p.000909: January 30, 2020
p.000909: (1) PROHIBITION.—No person may be denied or deprived of Federal civilian employment or a Federal professional or other
p.000909: license or right solely on the grounds of prior substance abuse.
p.000909: (2) APPLICATION.—This subsection shall not apply to em- ployment in—
p.000909: (A) the Central Intelligence Agency;
p.000909: (B) the Federal Bureau of Investigation;
p.000909: (C) the National Security Agency;
p.000909: (D) any other department or agency of the Federal Government designated for purposes of national security
p.000909: by the President; or
p.000909: (E) in any position in any department or agency of the Federal Government, not referred to in subparagraphs (A) through
p.000909: (D), which position is determined pursuant to reg- ulations prescribed by the head of such agency or depart-
p.000909: ment to be a sensitive position.
p.000909: (3) REHABILITATION ACT.—The inapplicability of the prohi- bition described in paragraph (1) to the employment described
p.000909: in paragraph (2) shall not be construed to reflect on the appli- cability of the Rehabilitation Act of 1973 or other
p.000909: anti-discrimi- nation laws to such employment.
p.000909: (c) CONSTRUCTION.—This section shall not be construed to pro- hibit the dismissal from employment of a Federal civilian
p.000909: employee who cannot properly function in his employment.
p.000909: SEC. 542. ø290dd–1¿ ADMISSION OF SUBSTANCE ABUSERS TO PRIVATE AND PUBLIC HOSPITALS AND OUTPATIENT FACILITIES.
p.000909: (a) NONDISCRIMINATION.—Substance abusers who are suffering from medical conditions shall not be discriminated
p.000909: against in ad- mission or treatment, solely because of their substance abuse, by any private or public
p.000909: general hospital, or outpatient facility (as de- fined in section 1624(4)) which receives support in any form
p.000909: from any program supported in whole or in part by funds appropriated to any Federal department or agency.
p.000909: (b) REGULATIONS.—
p.000909: (1) IN GENERAL.—The Secretary shall issue regulations for the enforcement of the policy of subsection (a) with
p.000909: respect to the admission and treatment of substance abusers in hospitals and outpatient facilities which receive
p.000909: support of any kind from any program administered by the Secretary. Such regula- tions shall include procedures
p.000909: for determining (after oppor- tunity for a hearing if requested) if a violation of subsection (a) has occurred,
p.000909: notification of failure to comply with such sub- section, and opportunity for a violator to comply with such
p.000909: sub- section. If the Secretary determines that a hospital or out- patient facility subject to such
...

p.001081: has received an award under sub- section (a)(1) or (a)(2) of section 751, satisfies the requirements in section
p.001081: 751(d)(1), and has as one of its principal functions the operation of an area health education center.
p.001081: Appropriate organizations may include hospitals, health organizations with accredited primary care training
p.001081: programs, accredited physi- cian assistant educational programs associated with a college or university,
p.001081: and universities or colleges not operating a school of medicine or osteopathic medicine.
p.001081: (13) AREA HEALTH EDUCATION CENTER PROGRAM.—The term ‘‘area health education center program’’ means
p.001081: coopera- tive program consisting of an entity that has received an award under subsection (a)(1) or
p.001081: (a)(2) of section 751 for the purpose of planning, developing, operating, and evaluating an area health
p.001081: education center program and one or more area health education centers, which carries out the required activi-
p.001081: ties described in section 751(c), satisfies the program require- ments in such section, has as one of
p.001081: its principal functions identifying and implementing strategies and activities that ad- dress health care workforce
p.001081: needs in its service area, in coordi- nation with the local workforce investment boards.
p.001081: (14) CLINICAL SOCIAL WORKER.—The term ‘‘clinical social worker’’ has the meaning given the term in section
p.001081: 1861(hh)(1) of the Social Security Act (42 U.S.C. 1395x(hh)(1)).
p.001081: (15) CULTURAL COMPETENCY.—The term ‘‘cultural com- petency’’ shall be defined by the Secretary in a
p.001081: manner con- sistent with section 1707(d)(3).
p.001081: (16) DIRECT CARE WORKER.—The term ‘‘direct care worker’’ has the meaning given that term in the 2010
p.001081: Standard Occu- pational Classifications of the Department of Labor for Home Health Aides [31–1011],
p.001081: Psychiatric Aides [31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
p.001081: (17) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001081: given that term in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
p.001081: (18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.— The term ‘‘frontier health professional shortage area’’
p.001081: means an area—
p.001081:
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p.001081: January 30, 2020
p.001081: (A) with a population density less than 6 persons per square mile within the service area; and
p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001099: capital contributions and from funds deposited therein pursuant to section 835(b)(2)(B).
p.001099: (2) The remainder of such balance shall be paid to the school.
p.001099: (b) If a capital distribution is made under subsection (a), the school involved shall, after such capital
p.001099: distribution, pay to the Sec- retary, not less often than quarterly, the same proportionate share of amounts received
p.001099: by the school in payment of principal or inter- est on loans made from the loan fund established under
p.001099: section 835(b) as determined by the Secretary under subsection (a).
p.001099: (c)(1) Within 90 days after the termination of any agreement with a school under section 835 or the
p.001099: termination in any other manner of a school’s participation in the loan program under this subpart 7,
p.001099: such school shall pay to the Secretary from the balance of the loan fund of such school established
p.001099: under section 835, an amount which bears the same ratio to the balance in such fund on the date of such
p.001099: termination as the total amount of the Federal capital contributions to such fund by the Secretary pursuant to
p.001099: sec- tion 835(b)(2)(A) bears to the total amount in such fund on such date derived from such Federal
p.001099: capital contributions and from funds deposited in the fund pursuant to section 835(b)(2)(B). The remainder
p.001099: of such balance shall be paid to the school.
p.001099: (2) A school to which paragraph (1) applies shall pay to the Secretary after the date on which payment
p.001099: is made under such paragraph and not less than quarterly, the same proportionate share of amounts
p.001099: received by the school after the date of termi- nation referred to in paragraph (1) in payment of principal or
p.001099: inter- est on loans made from the loan fund as was determined for the Secretary under such paragraph.
p.001099: ADMINISTRATIVE PROVISIONS
p.001099: SEC. 840. ø297g¿ The Secretary may agree to modifications of agreements made under this part, and may
p.001099: compromise, waive, or release any right, title, claim, or demand of the United States aris- ing or acquired under this
p.001099: part.
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p.001099: January 30, 2020
p.001099: 7 So in law. Probably should read ‘‘part’’.
p.001099:
p.001099: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001101: PUBLIC HEALTH SERVICE ACT
p.001101: Sec. 846
p.001101:
p.001101: PROCEDURES FOR APPEAL OF TERMINATIONS
p.001101: SEC. 842. 8 ø297i¿ In any case in which the Secretary intends to terminate an agreement with a school
p.001101: of nursing under this part, the Secretary shall provide the school with a written notice specifying such
p.001101: intention and stating that the school may request a formal hearing with respect to such termination. If the
p.001101: school re- quests such a hearing within 30 days after the receipt of such no- tice, the Secretary shall provide
p.001101: such school with a hearing con- ducted by an administrative law judge.
p.001101: LOAN REPAYMENT AND SCHOLARSHIP PROGRAMS
p.001101: SEC. 846. 9 ø297n¿ (a) IN GENERAL.—In the case of any indi- vidual—
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p.001205: radioactive.
p.001205: (4) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001205: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001205: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001205: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001205: private entities.
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001205:
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p.001205: Sec. 1271 PUBLIC HEALTH SERVICE ACT 1206
p.001205:
p.001205: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001205: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005, and such
p.001205: sums as may be necessary for each of the fiscal years 2009 through 2012.
p.001205: PART G—POISON CONTROL
p.001205: SEC. 1271. ø300d–71¿ MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER AND OTHER COMMUNICATION CAPABILITIES.
p.001205: (a) IN GENERAL.—The Secretary—
p.001205: (1) shall provide coordination and assistance to poison con- trol centers for the establishment and maintenance of a
p.001205: nation- wide toll-free phone number, to be used to access such centers; and
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p.001205: (2) may provide coordination and assistance to poison con- trol centers and consult with professional organizations for
p.001205: the establishment, implementation, and maintenance of other com- munication technologies to be used to access such
p.001205: centers.
p.001205: (b) ROUTING CONTACTS WITH POISON CONTROL CENTERS.—Not later than 18 months after the date of enactment of this
p.001205: subsection, the Secretary shall coordinate with the Chairman of the Federal Communications Commission, to
p.001205: the extent technically and eco- nomically feasible, to ensure that communications with the na- tional
p.001205: toll-free number are routed to the appropriate poison control center based on the physical location of the contact
p.001205: rather than the area code of the contact device.
p.001205: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001205: $700,000 for each of fiscal years 2020 through 2024 for the establishment, implementa- tion, and maintenance
p.001205: activities carried out under subsections (a) and (b).
p.001205: SEC. 1272. ø300d–72¿ PROMOTING POISON CONTROL CENTER UTILIZA- TION.
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p.001207: (a) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to poison control centers accredited under
p.001207: subsection (c) (or granted a waiver under subsection (d)) and professional organiza- tions in the field of
p.001207: poison control for the purposes of preventing, and providing treatment recommendations for, poisonings and toxic
p.001207: exposures and complying with the operational requirements needed to sustain the accreditation of the center under
p.001207: subsection (c).
p.001207: (b) ADDITIONAL USES OF FUNDS.—In addition to the purposes described in subsection (a), a poison center
p.001207: or professional organi- zation awarded a grant, contract, or cooperative agreement under such subsection
p.001207: may also use amounts received under such grant, contract, or cooperative agreement—
p.001207: (1) to research, establish, implement, and evaluate best practices in the United States for poisoning and toxic
p.001207: exposure prevention, poison control center outreach, and emergency pre- paredness and response programs;
p.001207: (2) to research, develop, implement, revise, and commu- nicate standard patient management guidelines for
p.001207: commonly encountered toxic exposures;
p.001207: (3) to improve national toxic exposure surveillance by en- hancing cooperative activities between poison
p.001207: control centers in the United States, the Centers for Disease Control and Preven- tion, and other government
p.001207: agencies as determined to be ap- propriate and nonduplicative by the Secretary;
p.001207: (4) to research, improve, and enhance the communications and response capability and capacity of the nation’s network
p.001207: of poison control centers to facilitate increased access to the cen- ters through the integration and
p.001207: modernization of the current poison control centers communications and data system, in- cluding enhancing the
p.001207: network’s telephony, Internet, data and social networking technologies;
p.001207: (5) to develop, support, and enhance technology and capa- bilities of professional organizations in the
p.001207: field of poison con- trol to collect national poisoning, toxic occurrence, and related public health data;
p.001207: (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected
p.001207: by organiza- tions described in paragraph (5);
p.001207: (7) to support and expand the toxicologic expertise within poison control centers; and
p.001207: (8) to improve the capacity of poison control centers to an- swer high volumes of contacts and Internet
p.001207: communications, and to sustain and enhance the poison control center’s network capability to respond during times
p.001207: of national crisis or other public health emergencies.
p.001207: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001207: Sec. 1273 PUBLIC HEALTH SERVICE ACT 1208
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p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
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p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001297:
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p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
p.001299: (2) STANDARDIZED METHODS.—The Secretary shall estab- lish standardized methods for making the estimates
p.001299: required in subsection (b)(11) with respect to a State. A funding agree- ment for a grant under section
p.001299: 1911 for the State is that the State will utilize such methods in making the estimates.
p.001299: (3) DATE CERTAIN FOR COMPLIANCE BY SECRETARY.—Not later than 90 days after the date of the
p.001299: enactment of the ADAMHA Reorganization Act 1, the Secretary shall establish the definitions described in
p.001299: paragraph (1), shall begin dissemi- nation of the definitions to the States, and shall establish the
p.001299: standardized methods described in paragraph (2).
p.001299: (d) REQUIREMENT OF IMPLEMENTATION OF PLAN.—
p.001299: (1) COMPLETE IMPLEMENTATION.—Except as provided in paragraph (2), in making a grant under section 1911 to a State
p.001299: for a fiscal year, the Secretary shall make a determination of the extent to which the State has
p.001299: implemented the plan re- quired in subsection (a). If the Secretary determines that a State has not
p.001299: completely implemented the plan, the Secretary shall reduce the amount of the allotment under section
p.001299: 1911 for the State for the fiscal year involved by an amount equal to 10 percent of the amount determined
p.001299: under section 1918 for the State for the fiscal year.
p.001299: (2) SUBSTANTIAL IMPLEMENTATION AND GOOD FAITH EFFORT REGARDING FISCAL YEAR 1993.—
p.001299: (A) In making a grant under section 1911 to a State for fiscal year 1993, the Secretary shall make a
p.001299: determina- tion of the extent to which the State has implemented the plan required in subsection (a). If the Secretary
p.001299: determines that the State has not substantially implemented the plan, the Secretary shall, subject to subparagraph
p.001299: (B), reduce the amount of the allotment under section 1911 for the State for such fiscal year by an amount
p.001299: equal to 10 percent of the amount determined under section 1918 for the State for the fiscal year.
p.001299: (B) In carrying out subparagraph (A), if the Secretary determines that the State is making a good faith effort to
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p.001617: (C) PREDECESSORS.—Any reference in this subsection to an employer shall include a reference to any predecessor
p.001617: of such employer.
p.001617: (7) STATE OPTION TO EXTEND DEFINITION OF SMALL EM- PLOYER.—Notwithstanding paragraphs (2) and (4),
p.001617: nothing in this section shall prevent a State from applying this subsection by treating as a small employer,
p.001617: with respect to a calendar year and a plan year, an employer who employed an average of at least 1 but
p.001617: not more than 100 employees on business days during the preceding calendar year and who employs at least 1
p.001617: employee on the first day of the plan year.
p.001617: SEC. 2792. ø300gg–92¿ REGULATIONS.
p.001617: The Secretary, consistent with section 104 of the Health Care Portability and Accountability Act of 1996,
p.001617: may promulgate such regulations as may be necessary or appropriate to carry out the provisions of this
p.001617: title. The Secretary may promulgate any interim final rules as the Secretary determines are appropriate to carry out
p.001617: this title.
p.001617: SEC. 2793. ø300gg–93¿ HEALTH INSURANCE CONSUMER INFORMATION.
p.001617: (a) IN GENERAL.—The Secretary shall award grants to States to enable such States (or the Exchanges
p.001617: operating in such States) to establish, expand, or provide support for—
p.001617: (1) offices of health insurance consumer assistance; or
p.001617: (2) health insurance ombudsman programs.
p.001617: (b) ELIGIBILITY.—
p.001617: (1) IN GENERAL.—To be eligible to receive a grant, a State shall designate an independent office of health
p.001617: insurance con- sumer assistance, or an ombudsman, that, directly or in coordi- nation with State health insurance
p.001617: regulators and consumer assistance organizations, receives and responds to inquiries and complaints
p.001617: concerning health insurance coverage with re- spect to Federal health insurance requirements and under
p.001617: State law.
p.001617: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001617:
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p.001617: Sec. 2794 PUBLIC HEALTH SERVICE ACT 1618
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p.001617: January 30, 2020
p.001617:
p.001617: (2) CRITERIA.—A State that receives a grant under this section shall comply with criteria established by the
p.001617: Secretary for carrying out activities under such grant.
p.001617: (c) DUTIES.—The office of health insurance consumer assist- ance or health insurance ombudsman shall—
p.001617: (1) assist with the filing of complaints and appeals, includ- ing filing appeals with the internal appeal or grievance
...

p.001627: needed for the proper functioning of the health care and public health sectors that need to be maintained
p.001627: through any emergency or disaster, in- cluding entities capable of assisting with, responding to, and
p.001627: mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary
p.001627: pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T. Stafford
p.001627: Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods
p.001627: to exchange critical informa- tion and deliver products consumed or used to preserve, pro- tect, or sustain
p.001627: life, health, or safety, and sharing of specialized expertise.
p.001627: (6) LEADERSHIP.—Provide leadership in international pro- grams, initiatives, and policies that deal with public
p.001627: health and medical emergency preparedness and response.
p.001627: (7) COUNTERMEASURES BUDGET PLAN.—Develop, and up- date not later than March 15 of each year, a coordinated
p.001627: 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with
p.001627: respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the
p.001627: Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to
p.001627: develop qualified countermeasures (as defined in sec- tion 319F–1), security countermeasures (as defined in
p.001627: section 319F–2), and qualified pandemic or epidemic products (as de-
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001627:
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p.001627:
p.001627: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1628
p.001627: fined in section 319F–3) for each such threat. Each such plan shall—
p.001627:
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p.001627: January 30, 2020
p.001627: (A) include consideration of the entire medical coun- termeasures enterprise, including—
p.001627: (i) basic research and advanced research and de- velopment;
p.001627: (ii) approval, clearance, licensure, and authorized uses of products;
p.001627: (iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing ca-
...

p.001629: (3) exercise the responsibilities and authorities of the Sec- retary with respect to the coordination of—
p.001629: (A) the Public Health Emergency Preparedness Coop- erative Agreement Program pursuant to section 319C–1;
p.001629: (B) the Strategic National Stockpile pursuant to sec- tion 319F–2; and
p.001629: (C) the Cities Readiness Initiative; and
p.001629: (4) assume other duties as determined appropriate by the Secretary.
p.001629: (d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
p.001629: (1) IN GENERAL.—Not later than March 15, 2020, and bien- nially thereafter, the Assistant Secretary for Preparedness
p.001629: and Response shall develop and submit to the appropriate commit- tees of Congress a coordinated strategy and
p.001629: accompanying im- plementation plan for medical countermeasures to address chemical, biological,
p.001629: radiological, and nuclear threats. In devel- oping such a plan, the Assistant Secretary for Preparedness and
p.001629: Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section
p.001629: 2811–1. Such strategy and plan shall be known as the ‘‘Public Health Emergency Medical Countermeasures Enterprise
p.001629: Strat- egy and Implementation Plan’’.
p.001629: (2) REQUIREMENTS.—The plan under paragraph (1) shall—
p.001629: (A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a
p.001629: threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in
p.001629: section 319F–1), security countermeasures (as defined in section 319F–2), or quali- fied pandemic or
p.001629: epidemic products (as defined in section 319F–3) for each threat;
p.001629: (B) evaluate the progress of all activities with respect to such countermeasures or products, including
p.001629: research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
p.001629: (C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or
p.001629: products, and ancillary medical supplies to assist with the utiliza- tion of such countermeasures or
p.001629: products, to address a
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001629:
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p.001629: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1630
p.001629: chemical, biological, radiological, and nuclear threat or threats;
p.001629: (D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced
p.001629: research and development and procurement, that in- cludes—
p.001629: (i) the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudica-
...

p.001639: Secretary shall modify the policies of the National Disaster Medical Sys- tem as necessary.
p.001639: (2) JOINT REVIEW AND MEDICAL SURGE CAPACITY STRATEGIC PLAN.—
p.001639:
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p.001639: January 30, 2020
p.001639: (A) REVIEW.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.001639: Advancing Innovation Act of 2019, the Secretary, in coordination with the Secretary of Homeland Security, the
p.001639: Secretary of Defense, and the Secretary of Veterans Af- fairs, shall conduct a joint review of the National
p.001639: Disaster Medical System. Such review shall include—
p.001639: (i) an evaluation of medical surge capacity, as de- scribed in section 2803(a);
p.001639: (ii) an assessment of the available workforce of the intermittent disaster response personnel described in
p.001639: subsection (c);
p.001639: (iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to
p.001639: simultaneously respond to multiple public health emergencies and the capacity to respond to a nation- wide
p.001639: public health emergency;
p.001639: (iv) the effectiveness of efforts to recruit, retain, and train such workforce; and
p.001639: (v) gaps that may exist in such workforce and rec- ommendations for addressing such gaps.
p.001639: (B) UPDATES.—As part of the National Health Security Strategy under section 2802, the Secretary shall update the
p.001639: findings from the review under subparagraph (A) and provide recommendations to modify the policies of the Na-
p.001639: tional Disaster Medical System as necessary.
p.001639: (3) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI- TIES.—In carrying out paragraph (1), the Secretary shall
p.001639: estab- lish criteria regarding the participation of States and private entities in the National Disaster
p.001639: Medical System, including cri- teria regarding agreements for such participation. The criteria shall include the
p.001639: following:
p.001639: (A) Provisions relating to the custody and use of Fed- eral personal property by such entities, which
p.001639: may in the
p.001639: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001639:
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p.001641: PUBLIC HEALTH SERVICE ACT
p.001641: Sec. 2812
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p.001649: such family caregivers in making informed deci- sions about respite care services will be provided using grant or
p.001649: cooperative agreement funds;
p.001649: (vi) a plan for administration, collaboration, and coordination of the proposed respite care
p.001649: activities with other related services or programs offered by public or private, nonprofit entities,
p.001649: including area agencies on aging;
p.001649: (vii) how the population, including family care- givers, care recipients, and relevant public or private
p.001649: agencies, will participate in the planning and imple- mentation of the proposed respite care activities;
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001649:
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p.001651: 1651
p.001651: PUBLIC HEALTH SERVICE ACT
p.001651: Sec. 2902
p.001651:
p.001651: (viii) how the proposed respite care activities will make use, to the maximum extent feasible, of other
p.001651: Federal, State, and local funds, programs, contribu- tions, other forms of reimbursements, personnel, and
p.001651: facilities;
p.001651: (ix) respite care services available to family care- givers in the eligible State agency’s State or
p.001651: locality, including unmet needs and how the eligible State agency’s plan for use of funds will improve
p.001651: the coordi- nation and distribution of respite care services for family caregivers of children and adults
p.001651: with special needs;
p.001651: (x) the criteria used to identify family caregivers eligible for respite care services;
p.001651: (xi) how the quality and safety of any respite care services provided will be monitored, including methods to ensure
p.001651: that respite care workers and volunteers are appropriately screened and possess the necessary skills to care
p.001651: for the needs of the care recipient in the absence of the family caregiver; and
p.001651: (xii) the results expected from proposed respite care activities and the procedures to be used for evalu- ating
p.001651: those results;
p.001651: (C) assurances that, where appropriate, the eligible State agency will have a system for maintaining the
p.001651: con- fidentiality of care recipient and family caregiver records; and
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p.001651: January 30, 2020
p.001651: (D) a memorandum of agreement regarding the joint responsibility for the eligible State agency’s lifespan
p.001651: res- pite program between—
p.001651: (i) the eligible State agency; and
p.001651: (ii) a public or private nonprofit statewide respite coalition or organization.
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p.001683: (9) promoting the use of electronic health records for qual- ity improvement including through quality measures
p.001683: reporting; and
p.001683:
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p.001683: January 30, 2020
p.001683: (10) such other activities as the Secretary may specify.
p.001683: (e) PLAN.—
p.001683: (1) IN GENERAL.—A plan described in this subsection is a plan that describes the activities to be
p.001683: carried out by a State or by the qualified State-designated entity within such State to
p.001683: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001683:
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p.001685: PUBLIC HEALTH SERVICE ACT
p.001685: Sec. 3013
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p.001685: January 30, 2020
p.001685: facilitate and expand the electronic movement and use of health information among organizations
p.001685: according to nation- ally recognized standards and implementation specifications.
p.001685: (2) REQUIRED ELEMENTS.—A plan described in paragraph
p.001685: (1) shall—
p.001685: (A) be pursued in the public interest;
p.001685: (B) be consistent with the strategic plan developed by the National Coordinator, (and, as available) under section
p.001685: 3001;
p.001685: (C) include a description of the ways the State or qualified State-designated entity will carry out the
p.001685: activi- ties described in subsection (b); and
p.001685: (D) contain such elements as the Secretary may re- quire.
p.001685: (f) QUALIFIED STATE-DESIGNATED ENTITY.—For purposes of this section, to be a qualified State-designated
p.001685: entity, with respect to a State, an entity shall—
p.001685: (1) be designated by the State as eligible to receive awards under this section;
p.001685: (2) be a not-for-profit entity with broad stakeholder rep- resentation on its governing board;
p.001685: (3) demonstrate that one of its principal goals is to use in- formation technology to improve health care quality
p.001685: and effi- ciency through the authorized and secure electronic exchange and use of health information;
p.001685: (4) adopt nondiscrimination and conflict of interest policies that demonstrate a commitment to open, fair, and
p.001685: nondiscrim- inatory participation by stakeholders; and
p.001685: (5) conform to such other requirements as the Secretary may establish.
p.001685: (g) REQUIRED CONSULTATION.—In carrying out activities de- scribed in subsections (b) and (c), a State or
p.001685: qualified State-des- ignated entity shall consult with and consider the recommenda- tions of—
p.001685: (1) health care providers (including providers that provide services to low income and underserved populations);
p.001685: (2) health plans;
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p.000133: shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws.
p.000133: (3) ELIGIBILITY.—To be eligible to receive funds under paragraph (1), an entity shall—
p.000133: (A) prepare and submit to the State an application at such time, in such manner and containing such informa-
p.000133: tion as the State may require; and
p.000133: (B) be a public elementary or secondary school—
p.000133: (i) that is located in an urban area in which and more than 50 percent of the student population is par-
p.000133: ticipating in Federal or State free or reduced meal pro- grams; or
p.000133: (ii) that is located in a rural area and, with re- spect to the school district in which the school
p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
p.000133: interpretation, (including determinants of poor oral health among vulnerable populations), a
p.000133: multi-dimensional delivery system for oral health, and to implement science-based programs (including
p.000133: dental sealants and community water fluoridation) to improve oral health.
p.000133: (2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
p.000133: ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through
p.000133: 2014.
p.000133: (e) DEFINITIONS.—For purposes of this section, the term ‘‘In- dian tribe’’ means an Indian tribe or tribal
p.000133: organization as defined in section 4(b) and section 4(c) of the Indian Self-Determination and Education
p.000133: Assistance Act.
p.000133: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000133: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000133:
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p.000135: 135
p.000135: PUBLIC HEALTH SERVICE ACT
p.000135: Sec. 317O
p.000135:
p.000135: SEC. 317N. ø247b–15¿ SURVEILLANCE AND EDUCATION REGARDING IN- FECTIONS ASSOCIATED WITH ILLICIT DRUG USE AND
p.000135: OTHER RISK FACTORS.
...

p.000201: in para- graph (9) or (10) of section 2302(b) of such title; and
p.000201: (E) accords a preference, among equally qualified per- sons, to persons who are preference eligibles (as defined in
p.000201: section 2108(3) of such title).
p.000201: (3) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for
p.000201: appointments under this subsection.
p.000201: (f) ACTIONS COMMITTED TO AGENCY DISCRETION.—Actions by the Secretary under the authority of this section are
p.000201: committed to agency discretion.
p.000201: SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECU-
p.000201: RITY COUNTERMEASURE PROCUREMENTS. 22
p.000201: (a) STRATEGIC NATIONAL STOCKPILE.—
p.000201: (1) IN GENERAL.—The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and
p.000201: the Di- rector of the Centers for Disease Control and Prevention, and in coordination with the Secretary
p.000201: of Homeland Security (re- ferred to in this section as the ‘‘Homeland Security Secretary’’), shall maintain a
p.000201: stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other
p.000201: supplies in such numbers, types, and amounts as are determined con- sistent with section 2811 by the
p.000201: Secretary to be appropriate and practicable, taking into account other available sources, to provide for and
p.000201: optimize the emergency health security of the United States, including the emergency health security of chil-
p.000201: dren and other vulnerable populations, in the event of a bioter- rorist attack or other public health emergency and, as
p.000201: informed by existing recommendations of, or consultations with, the Public Health Emergency Medical
p.000201: Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the
p.000201: contents of such stockpile or stockpiles based on the review conducted under paragraph (2).
p.000201: (2) THREAT-BASED REVIEW.—
p.000201:
p.000201:
p.000201:
p.000201:
p.000201: January 30, 2020
p.000201: 22 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–2 and related
p.000201: provisions of law. Section 5 is included in the appendix to this compilation.
p.000201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 202
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p.000251: (C) TRAVEL EXPENSES.—Each member of the Board shall receive travel expenses, including per diem in lieu of
p.000251: subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5,
p.000251: United States Code.
p.000251: (D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board with the
p.000251: approval for the contributing agency without reim- bursement, and such detail shall be without
p.000251: interruption or loss of civil service status or privilege.
p.000251: (b) OTHER WORKING GROUPS.—The Secretary may establish a working group of experts, or may use an existing working
p.000251: group or advisory committee, to—
p.000251: (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified
p.000251: pandemic or epidemic product;
p.000251: (2) identify accepted animal models for particular diseases and conditions associated with any biological,
p.000251: chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify
p.000251: strategies to accelerate animal model and research tool development and validation; and
p.000251: (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified
p.000251: counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective
p.000251: with respect to children, pregnant women, and other vulnerable populations, and other issues regarding
p.000251: activities under this section that affect such populations.
p.000251: (c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same
p.000251: meaning in this section as such term is given in section 319L.
p.000251: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $1,000,000 to carry out this
p.000251: section for fiscal year 2007 and each fiscal year thereafter.
p.000251: HANSEN’S DISEASE PROGRAM
p.000251: SEC. 320. ø247e¿ (a)(1) At or through the National Hansen’s Disease Programs Center (located in the
p.000251: State of Louisiana), the Secretary shall without charge provide short-term care and treat- ment, including
p.000251: outpatient care, for Hansen’s disease and related complications to any person determined by the Secretary
p.000251: to be in need of such care and treatment. The Secretary may not at or through such Center provide
p.000251: long-term care for any such disease or complication.
p.000251: (2) The Center referred to in paragraph (1) shall conduct train- ing in the diagnosis and management of Hansen’s
p.000251: disease and re- lated complications, and shall conduct and promote the coordina-
p.000251: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000251:
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p.000253: PUBLIC HEALTH SERVICE ACT
p.000253: Sec. 320A
p.000253:
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p.000279: programs described in this section, to the extent practicable, with Fed- eral and State agencies and
p.000279: nonprofit organizations that are operating similar grant programs, to maximize the effect of public dollars
p.000279: in funding meritorious proposals.
p.000279: (3) PREFERENCE.—In awarding grants under this section, the Secretary shall give preference to entities that—
p.000279: (A) are located in health professional shortage areas or medically underserved communities, or serve medically un-
p.000279: derserved populations; or
p.000279: (B) propose to develop projects with a focus on primary care, and wellness and prevention strategies.
p.000279: (i) REPORT.—Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate
p.000279: committees of Con- gress a report on the progress and accomplishments of the grant programs described in
p.000279: subsections (e), (f), and (g).
p.000279: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $45,000,000
p.000279: for each of fiscal years 2008 through 2012.
p.000279: SEC. 330A–1. ø254c–1a¿ GRANTS TO NURSE–MANAGED HEALTH CLINICS.
p.000279: (a) DEFINITIONS.—
p.000279: (1) COMPREHENSIVE PRIMARY HEALTH CARE SERVICES.—In this section, the term ‘‘comprehensive primary health
p.000279: care services’’ means the primary health services described in sec- tion 330(b)(1).
p.000279: (2) NURSE-MANAGED HEALTH CLINIC.—The term ‘‘nurse- managed health clinic’’ means a nurse-practice
p.000279: arrangement, managed by advanced practice nurses, that provides primary care or wellness services to
p.000279: underserved or vulnerable popu- lations and that is associated with a school, college, university or department of
p.000279: nursing, federally qualified health center, or independent nonprofit health or social services agency.
p.000279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000279:
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p.000281: 281
p.000281: PUBLIC HEALTH SERVICE ACT
p.000281: Sec. 330B
p.000281:
p.000281: (b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants for the cost of the operation of nurse-managed health
p.000281: clinics that meet the requirements of this section.
p.000281: (c) APPLICATIONS.—To be eligible to receive a grant under this section, an entity shall—
p.000281: (1) be an NMHC; and
p.000281: (2) submit to the Secretary an application at such time, in such manner, and containing—
p.000281: (A) assurances that nurses are the major providers of services at the NMHC and that at least 1
p.000281: advanced prac- tice nurse holds an executive management position within the organizational structure of the NMHC;
p.000281: (B) an assurance that the NMHC will continue pro- viding comprehensive primary health care services
p.000281: or wellness services without regard to income or insurance status of the patient for the duration of the
p.000281: grant period; and
p.000281: (C) an assurance that, not later than 90 days of receiv-
p.000281: ing a grant under this section, the NMHC will establish a community advisory committee, for which a majority of the
...

p.000383: subject to administrative and judicial review under that section in the same manner as the amount of
p.000383: payment under section 1186(d) of such Act is subject to review under such section.
p.000383: (g) FUNDING.—
p.000383: (1) IN GENERAL.—To carry out this section, there are ap- propriated such sums as may be necessary, not
p.000383: to exceed
p.000383: $230,000,000, for the period of fiscal years 2011 through 2015,
p.000383: $60,000,000 for each of fiscal years 2016 and 2017,
p.000383: $126,500,000 for each of fiscal years 2018 and 2019, and
p.000383: $81,445,205 for the period beginning on October 1, 2019, and ending on May 22, 2020, to remain
p.000383: available until expended.
p.000383: (2) ADMINISTRATIVE EXPENSES.—Of the amount made available to carry out this section for any fiscal
p.000383: year, the Sec- retary may not use more than 5 percent of such amount for the expenses of administering this section.
p.000383: (h) ANNUAL REPORTING REQUIRED.—
p.000383: (1) ANNUAL REPORT.—The report required under this para- graph for a qualified teaching health center for a fiscal year
p.000383: is a report that includes (in a form and manner specified by the Secretary) the following information for
p.000383: the residency academic year completed immediately prior to such fiscal year:
p.000383: (A) The types of primary care resident approved train- ing programs that the qualified teaching health center pro-
p.000383: vided for residents.
p.000383: (B) The number of approved training positions for resi- dents described in paragraph (4).
p.000383: (C) The number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year and care for vulnerable
p.000383: pop- ulations living in underserved areas.
p.000383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000383:
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p.000383: Sec. 340H PUBLIC HEALTH SERVICE ACT 384
p.000383:
p.000383: (D) The number of patients treated by residents de- scribed in paragraph (4).
p.000383: (E) The number of visits by patients treated by resi- dents described in paragraph (4).
p.000383: (F) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents entering primary care practice (meaning any of the areas of practice listed in the
p.000383: definition of a pri- mary care residency program in section 749A).
p.000383: (G) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents who entered practice at a health care fa- cility—
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p.000401:
p.000401: (2) DATE OF APPROVAL.—For purposes of this section, with respect to an application described in paragraph (1),
p.000401: references to the date of approval of such application, or licensure of the product subject to such
p.000401: application, shall mean the later of—
p.000401: (A) the date an application is approved under sub- section (a); or
p.000401: (B) the date of issuance of the interim final rule con- trolling the biological product.
p.000401: SEC. 351A. ø262a¿ ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS. 60
p.000401: (a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (A) IN GENERAL.—The Secretary shall by regulation establish and maintain a list of each biological agent
p.000401: and each toxin that has the potential to pose a severe threat to public health and safety.
p.000401: (B) CRITERIA.—In determining whether to include an agent or toxin on the list under subparagraph (A), the Sec-
p.000401: retary shall—
p.000401: (i) consider—
p.000401: (I) the effect on human health of exposure to the agent or toxin;
p.000401: (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is
p.000401: transferred to humans;
p.000401: (III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent
p.000401: any illness resulting from infection by the agent or toxin; and
p.000401: (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary
p.000401: considers appropriate; and
p.000401: (ii) consult with appropriate Federal departments and agencies and with scientific experts representing
p.000401: appropriate professional groups, including groups with pediatric expertise.
p.000401: (2) BIENNIAL REVIEW.—The Secretary shall review and re- publish the list under paragraph (1) biennially,
p.000401: or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
p.000401: (b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX-
p.000401: INS.—The Secretary shall by regulation provide for—
p.000401: (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including
p.000401: measures to ensure—
p.000401: (A) proper training and appropriate skills to handle such agents and toxins; and
p.000401:
p.000401:
p.000401:
p.000401:
p.000401:
p.000401:
p.000401: January 30, 2020
p.000401: 60 A program is carried out by the Secretary of Agriculture with respect to each biological agent and
p.000401: each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant
p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
p.000401: Subtitle C of such title (section 221 et seq.; 116 Stat. 657) relates to interagency coordination of the two
p.000401: programs.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000401:
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p.000587: to be appro- priated $50,599,000 for each of fiscal years 2020 through 2024.
p.000587: (c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN OTHER PROGRAMS.—To carry out sections 399CC and
p.000587: 409C, there are authorized to be appropriated $296,000,000 for each of fiscal years 2020 through 2024.
p.000587: PART S—HEALTH CARE QUALITY PROGRAMS
p.000587: Subpart I—National Strategy for Quality Improvement in Health Care
p.000587:
p.000587:
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p.000587: January 30, 2020
p.000587: SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
p.000587: (a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
p.000587: (1) NATIONAL STRATEGY.—The Secretary, through a trans- parent collaborative process, shall establish a national
p.000587: strategy to improve the delivery of health care services, patient health outcomes, and population health.
p.000587: (2) IDENTIFICATION OF PRIORITIES.—
p.000587: (A) IN GENERAL.—The Secretary shall identify national priorities for improvement in developing the strategy
p.000587: under paragraph (1).
p.000587: (B) REQUIREMENTS.—The Secretary shall ensure that priorities identified under subparagraph (A) will—
p.000587: (i) have the greatest potential for improving the health outcomes, efficiency, and patient-centeredness of
p.000587: health care for all populations, including children and vulnerable populations;
p.000587: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000587:
p.000587:
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p.000587: Sec. 399HH PUBLIC HEALTH SERVICE ACT 588
p.000587:
p.000587:
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p.000587:
p.000587: (ii) identify areas in the delivery of health care services that have the potential for rapid improvement in
p.000587: the quality and efficiency of patient care;
p.000587: (iii) address gaps in quality, efficiency, compara- tive effectiveness information (taking into consider-
p.000587: ation the limitations set forth in subsections (c) and
p.000587: (d) of section 1182 of the Social Security Act), and health outcomes measures and data aggregation tech-
p.000587: niques;
p.000587: (iv) improve Federal payment policy to emphasize quality and efficiency;
p.000587: (v) enhance the use of health care data to improve quality, efficiency, transparency, and outcomes;
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p.001023:
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p.001023: January 30, 2020
p.001023:
p.001023: (2) PREFERENCE IN MAKING AWARDS UNDER THIS SUB- SECTION.—In making awards of grants and
p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
...

p.001027: pediatric, or public health dentistry shall include entities that have programs in dental or dental hygiene schools,
p.001027: or approved residency or advanced edu- cation programs in the practice of general, pediatric, or public
p.001027: health dentistry. Eligible entities may partner with schools of pub- lic health to permit the education of dental
p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001027:
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
p.001027: contract under subsection (a) shall be 5 years. The provision of such payments shall be subject to annual
p.001027: approval by the Secretary and subject to the availability of appropriations for the fiscal year involved to
p.001027: make the payments.
p.001027: (f) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out subsections (a) and (b), there is
p.001027: authorized to be ap- propriated $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of
p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
p.001027: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
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p.001053:
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p.001053: January 30, 2020
p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
...

p.001141: through multiple media and appropriate formats to reflect the varying needs of health care providers and
p.001141: consumers and diverse lev- els of health literacy.
p.001141: (2) LINKAGE TO HEALTH INFORMATION TECHNOLOGY.—The Secretary shall ensure that research findings and
p.001141: results gen- erated by the Center are shared with the Office of the National
p.001141: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001141:
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p.001141: Sec. 934 PUBLIC HEALTH SERVICE ACT 1142
p.001141:
p.001141: Coordinator of Health Information Technology and used to in- form the activities of the health information
p.001141: technology exten- sion program under section 3012, as well as any relevant standards, certification
p.001141: criteria, or implementation specifica- tions.
p.001141: (e) PRIORITIZATION.—The Director shall identify and regularly update a list of processes or systems on
p.001141: which to focus research and dissemination activities of the Center, taking into account—
p.001141: (1) the cost to Federal health programs;
p.001141: (2) consumer assessment of health care experience;
p.001141: (3) provider assessment of such processes or systems and opportunities to minimize distress and injury to
p.001141: the health care workforce;
p.001141: (4) the potential impact of such processes or systems on health status and function of patients,
p.001141: including vulnerable populations including children;
p.001141: (5) the areas of insufficient evidence identified under sub- section (c)(2)(B); and
p.001141: (6) the evolution of meaningful use of health information technology, as defined in section 3000.
p.001141: (f) COORDINATION.—The Center shall coordinate its activities with activities conducted by the Center for Medicare
p.001141: and Medicaid Innovation established under section 1115A of the Social Security Act.
p.001141:
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p.001141: January 30, 2020
p.001141: (g) FUNDING.—There is authorized to be appropriated to carry out this section $20,000,000 for fiscal years 2010
p.001141: through 2014.
p.001141: SEC. 934. ø299b–34¿ QUALITY IMPROVEMENT TECHNICAL ASSISTANCE AND IMPLEMENTATION.
p.001141: (a) IN GENERAL.—The Director, through the Center for Quality Improvement and Patient Safety of the Agency for
p.001141: Healthcare Re- search and Quality (referred to in this section as the ‘‘Center’’), shall award—
p.001141: (1) technical assistance grants or contracts to eligible enti- ties to provide technical support to institutions
p.001141: that deliver health care and health care providers (including rural and urban providers of services and
p.001141: suppliers with limited infra- structure and financial resources to implement and support quality improvement
...

p.001147: of treatment or, where appropriate, palliative care options;
p.001147: (B) to test such materials to ensure such materials are balanced and evidence based in aiding health care pro-
p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and
p.001147: (C) to educate providers on the use of such materials, including through academic curricula.
p.001147: (2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient decision aids developed and produced pursuant to a
p.001147: grant or contract under paragraph (1)—
p.001147: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed
p.001147: decision- making with health care providers;
p.001147: (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and man- ner
p.001147: that is age-appropriate and can be adapted for pa- tients, caregivers, and authorized representatives
p.001147: from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and
p.001147: diverse levels of health literacy;
p.001147: (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option
p.001147: over an- other; and
p.001147: (D) shall address health care decisions across the age span, including those affecting vulnerable
p.001147: populations in- cluding children.
p.001147: (3) DISTRIBUTION.—The Director shall ensure that patient decision aids produced with grants or contracts under
p.001147: this sec- tion are available to the public.
p.001147: (4) NONDUPLICATION OF EFFORTS.—The Director shall en- sure that the activities under this section of
p.001147: the Agency and other agencies, including the Centers for Disease Control and
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001147:
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p.001149: 1149
p.001149: PUBLIC HEALTH SERVICE ACT
p.001149: Sec. 937
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p.001149: January 30, 2020
p.001149: Prevention and the National Institutes of Health, are free of unnecessary duplication of effort.
p.001149: (e) GRANTS TO SUPPORT SHARED DECISIONMAKING IMPLEMEN-
p.001149: TATION.—
p.001149: (1) IN GENERAL.—The Secretary shall establish a program to provide for the phased-in development,
...

p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
...

p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001665:
p.001665:
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p.000245: January 30, 2020
p.000245: $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended.
p.000245: (e) INAPPLICABILITY OF CERTAIN PROVISIONS.—
p.000245: (1) DISCLOSURE.—
p.000245: (A) NONDISCLOSURE OF INFORMATION.—
p.000245: (i) IN GENERAL.—Information described in clause
p.000245: (ii) shall be deemed to be information described in sec- tion 552(b)(3) of title 5, United States Code.
p.000245: (ii) INFORMATION DESCRIBED.—The information de- scribed in this clause is information relevant to pro- grams of
p.000245: the Department of Health and Human Serv- ices that could compromise national security and re- veal significant
p.000245: and not otherwise publicly known vulnerabilities of existing medical or public health de- fenses against
p.000245: chemical, biological, radiological, or nu- clear threats, and is comprised of—
p.000245: (I) specific technical data or scientific informa- tion that is created or obtained during the coun- termeasure
p.000245: and product advanced research and development carried out under subsection (c);
p.000245: (II) information pertaining to the location se- curity, personnel, and research materials and methods
p.000245: of high-containment laboratories con- ducting research with select agents, toxins, or other agents
p.000245: with a material threat determination under section 319F–2(c)(2); or
p.000245: (III) security and vulnerability assessments.
p.000245: (B) REVIEW.—Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary
p.000245: every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or
p.000245: necessity of continued nondisclosure.
p.000245: (C) REPORTING.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Ad-
p.000245: vancing Innovation Act of 2019, and annually thereafter, the Secretary shall report to the Committee on
p.000245: Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
p.000245: Rep- resentatives on the number of instances in which the Sec- retary has used the authority under this
p.000245: subsection to withhold information from disclosure, as well as the na- ture of any request under section
p.000245: 552 of title 5, United States Code that was denied using such authority.
p.000245: (D) SUNSET.—This paragraph shall cease to have force or effect on the date that is 17 years after the date of en-
p.000245: actment of the Pandemic and All-Hazards Preparedness Act.
p.000245: (2) REVIEW.—Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA
p.000245: under this section and the National Biodefense Science Board under section 319M shall each terminate on
p.000245: the date that is 5 years after the date on which each such group or Board, as applica- ble, was established.
p.000245: Such 5-year period may be extended by
p.000245: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000245:
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Health / Cognitive Impairment

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p.000481: (1) provide for an evaluation of each demonstration project for which a grant is made under section 395(a); and
p.000481: (2) not later than 6 months after the completion of such evaluations, submit to the Congress a report
p.000481: describing the findings made as a result of the evaluations.
p.000481: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000481: to be appropriated
p.000481: $5,000,000 for each of the fiscal years 1988 through 1990,
p.000481: $7,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
p.000481:
p.000481: Subpart II—Programs With Respect to Alzheimer’s Disease and Related Dementias
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p.000481: January 30, 2020
p.000481: SEC. 398. ø280c–3¿ COOPERATIVE AGREEMENTS TO STATES AND PUB- LIC HEALTH DEPARTMENTS FOR ALZHEIMER’S
p.000481: DISEASE AND RELATED DEMENTIAS.
p.000481: (a) IN GENERAL.—The Secretary, in coordination with the Di- rector of the Centers for Disease Control
p.000481: and Prevention and the heads of other agencies, as appropriate, shall award cooperative agreements to
p.000481: health departments of States, political subdivisions of States, and Indian tribes and tribal organizations,
p.000481: to address Alzheimer’s disease and related dementias, including by reducing cognitive decline, helping meet
p.000481: the needs of caregivers, and ad- dressing unique aspects of Alzheimer’s disease and related demen- tias to
p.000481: support the development and implementation of evidence- based interventions with respect to—
p.000481: (1) educating and informing the public, based on evidence- based public health research and data, about
p.000481: Alzheimer’s dis- ease and related dementias;
p.000481: (2) supporting early detection and diagnosis;
p.000481: (3) reducing the risk of potentially avoidable hospitaliza- tions for individuals with Alzheimer’s disease
p.000481: and related de- mentias;
p.000481: (4) reducing the risk of cognitive decline and cognitive im- pairment associated with Alzheimer’s disease and
p.000481: related de- mentias;
p.000481: (5) improving support to meet the needs of caregivers of in- dividuals with Alzheimer’s disease and related dementias;
p.000481: (6) supporting care planning and management for individ- uals with Alzheimer’s disease and related dementias.
p.000481: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000483: 483
p.000483: PUBLIC HEALTH SERVICE ACT
p.000483: Sec. 398
p.000483:
p.000483: (7) supporting other relevant activities identified by the Secretary or the Director of the Centers for
p.000483: Disease Control and Prevention, as appropriate
p.000483: (b) PREFERENCE.—In awarding cooperative agreements under this section, the Secretary shall give preference to
p.000483: applications that focus on addressing health disparities, including populations and geographic areas that
p.000483: have the highest prevalence of Alzheimer’s disease and related dementias.
p.000483: (c) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under this section, an eligible
p.000483: entity (pursuant to subsection (a)) shall prepare and submit to the Secretary an application at such time,
p.000483: in such manner, and containing such information as the Secretary may require, including a plan that describes—
p.000483: (1) how the applicant proposes to develop or expand, pro- grams to educate individuals through partnership
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p.000483: (2) by an entity that provides health services on a prepaid basis.
p.000483: (f) 93 NON-DUPLICATION OF EFFORT.—The Secretary shall en- sure that activities under any
p.000483: cooperative agreement awarded under this subpart do not unnecessarily duplicate efforts of other agencies
p.000483: and offices within the Department of Health and Human Services related to—
p.000483: (1) activities of centers of excellence with respect to Alz- heimer’s disease and related dementias
p.000483: described in section 398A; and
p.000483: (2) activities of public health departments with respect to Alzheimer’s disease and related dementias
p.000483: described in this section.
p.000483: SEC. 398A. ø280c–4¿ PROMOTION OF PUBLIC HEALTH KNOWLEDGE AND AWARENESS OF ALZHEIMER’S DISEASE AND RELATED DE- MENTIAS.
p.000483: (a) ALZHEIMER’S DISEASE AND RELATED DEMENTIAS PUBLIC HEALTH CENTERS OF EXCELLENCE.—
p.000483: (1) IN GENERAL.—The Secretary, in coordination with the Director of the Centers for Disease Control and
p.000483: Prevention and the heads of other agencies as appropriate, shall award grants, contracts, or cooperative agreements
p.000483: to eligible entities, such as institutions of higher education, State, tribal, and local health
p.000483: departments, Indian tribes, tribal organizations, asso- ciations, or other appropriate entities for the
p.000483: establishment or support of regional centers to address Alzheimer’s disease and related dementias by—
p.000483: (A) advancing the awareness of public health officials, health care professionals, and the public, on the most cur-
p.000483: rent information and research related to Alzheimer’s dis- ease and related dementias, including cognitive
p.000483: decline, brain health, and associated health disparities;
p.000483: (B) identifying and translating promising research findings, such as findings from research and activities
p.000483: con- ducted or supported by the National Institutes of Health, including Alzheimer’s Disease Research
p.000483: Centers author- ized by section 445, into evidence-based programmatic interventions for populations with
p.000483: Alzheimer’s disease and related dementias and caregivers for such populations; and
p.000483: (C) expanding activities, including through public-pri- vate partnerships related to Alzheimer’s disease and
p.000483: re- lated dementias and associated health disparities.
p.000483: (2) REQUIREMENTS.—To be eligible to receive a grant, con- tract, or cooperative agreement under this subsection, an
p.000483: enti- ty shall submit to the Secretary an application containing such
p.000483:
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p.000483: January 30, 2020
p.000483: 93 The placement of subsection (f) (as added to the end of the section by section 3(7) of Public Law 115–406) is so in
p.000483: law. The amendment probably should have been made to insert this new subsection before subsection (g) (as
p.000483: redesignated).
p.000483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000485: PUBLIC HEALTH SERVICE ACT
p.000485: Sec. 398A
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p.000485: January 30, 2020
p.000485: agreements and information as the Secretary may require, in- cluding a description of how the entity will—
p.000485: (A) coordinate, as applicable, with existing Federal, State, and tribal programs related to Alzheimer’s
p.000485: disease and related dementias;
p.000485: (B) examine, evaluate, and promote evidence-based interventions for individuals with Alzheimer’s disease
p.000485: and related dementias, including underserved populations with such conditions, and those who provide care for such
p.000485: indi- viduals; and
p.000485: (C) prioritize activities relating to—
p.000485: (i) expanding efforts, as appropriate, to implement evidence-based practices to address Alzheimer’s dis- ease and
p.000485: related dementias, including through the training of State, local, and tribal public health offi- cials
p.000485: and other health professionals on such practices;
p.000485: (ii) supporting early detection and diagnosis of Alzheimer’s disease and related dementias;
p.000485: (iii) reducing the risk of potentially avoidable hos- pitalizations of individuals with Alzheimer’s disease and
p.000485: related dementias;
p.000485: (iv) reducing the risk of cognitive decline and cog- nitive impairment associated with Alzheimer’s disease and related
p.000485: dementias;
p.000485: (v) enhancing support to meet the needs of care- givers of individuals with Alzheimer’s disease and re-
p.000485: lated dementias;
p.000485: (vi) reducing health disparities related to the care and support of individuals with Alzheimer’s disease and
p.000485: related dementias;
p.000485: (vii) supporting care planning and management for individuals with Alzheimer’s disease and related
p.000485: dementias; and
p.000485: (viii) supporting other relevant activities identified by the Secretary or the Director of the Centers for Dis- ease
p.000485: Control and Prevention, as appropriate.
p.000485: (3) CONSIDERATIONS.—In awarding grants, contracts, and cooperative agreements under this subsection, the
p.000485: Secretary shall consider, among other factors, whether the entity—
p.000485: (A) provides services to rural areas or other under- served populations;
p.000485: (B) is able to build on an existing infrastructure of services and public health research; and
p.000485: (C) has experience with providing care or caregiver support, or has experience conducting research related
p.000485: to Alzheimer’s disease and related dementias.
p.000485: (4) DISTRIBUTION OF AWARDS.—In awarding grants, con- tracts, or cooperative agreements under this
p.000485: subsection, the Secretary, to the extent practicable, shall ensure equitable dis- tribution of awards based on
p.000485: geographic area, including consid- eration of rural areas, and the burden of the disease within
p.000485: sub-populations.
p.000485: (5) DATA REPORTING AND PROGRAM OVERSIGHT.—With re- spect to a grant, contract, or cooperative agreement
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p.000485: Sec. 398B PUBLIC HEALTH SERVICE ACT 486
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p.000485: under this subsection, not later than 90 days after the end of the first year of the period of
p.000485: assistance, and annually there- after for the duration of the grant, contract, or agreement (in- cluding the
p.000485: duration of any renewal period as provided for under paragraph (5)), the entity shall submit data, as
p.000485: appro- priate, to the Secretary regarding—
p.000485: (A) the programs and activities funded under the grant, contract, or agreement; and
p.000485: (B) outcomes related to such programs and activities.
p.000485: (b) IMPROVING DATA ON STATE AND NATIONAL PREVALENCE OF
p.000485: ALZHEIMER’S DISEASE AND RELATED DEMENTIAS.—
p.000485: (1) IN GENERAL.—The Secretary shall, as appropriate, im- prove the analysis and timely reporting of data
p.000485: on the inci- dence and prevalence of Alzheimer’s disease and related de- mentias. Such data may include,
p.000485: as appropriate, information on cognitive decline, caregiving, and health disparities experi- enced by
p.000485: individuals with cognitive decline and their care- givers. The Secretary may award grants, contracts, or coopera-
p.000485: tive agreements to eligible entities for activities under this paragraph.
p.000485: (2) ELIGIBILITY.—To be eligible to receive a grant, contract, or cooperative agreement under this subsection, an entity
p.000485: shall be a public or nonprofit private entity, including institutions of higher education, State, local, and
p.000485: tribal health departments, and Indian tribes and tribal organizations, and submit to the Secretary an
p.000485: application at such time, in such manner, and containing such information as the Secretary may require.
p.000485: (3) DATA SOURCES.—The analysis, timely public reporting, and dissemination of data under this subsection may be
p.000485: carried out using data sources such as the following:
p.000485: (A) The Behavioral Risk Factor Surveillance System.
p.000485: (B) The National Health and Nutrition Examination Survey.
p.000485: (C) The National Health Interview Survey.
p.000485: (c) IMPROVED COORDINATION.—The Secretary shall ensure that activities and programs related to dementia under
p.000485: this section do not unnecessarily duplicate activities and programs of other agen- cies and offices within
p.000485: the Department of Health and Human Serv- ices.
p.000485: SEC. 398B. ø280c–5¿ GENERAL PROVISIONS.
p.000485: (a) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make a grant or cooperative agreement under
p.000485: sections 398 or 398A to an entity unless the entity agrees that not more than 5 percent of the grant
p.000485: or cooperative agreement will be expended for administrative expenses with respect to the grant or cooperative
p.000485: agreement.
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p.000529:
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p.000529: January 30, 2020
p.000529: (iv) to support newborn, infant, and young child hearing screening, evaluation, and intervention pro-
p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
p.000529: screening, evaluation, and intervention programs and systems;
p.000529: (iii) to collect data and report on newborn, infant, and young child hearing screening, evaluation, diag- nosis,
p.000529: and intervention programs and systems for ap- plied research, program evaluation, and policy im-
p.000529: provement;
p.000529: (iv) to identify the causes and risk factors for con- genital hearing loss;
p.000529: (v) to study the effectiveness of newborn, infant, and young child hearing screening, audiologic and
p.000529: medical evaluations and intervention programs and systems by assessing the health, intellectual and so-
p.000529: cial developmental, cognitive, and hearing status of these children at school age; and
p.000529: (vi) to promote the integration and interoper- ability of data regarding early hearing loss across mul-
p.000529: tiple sources to increase the flow of information be- tween clinical care and public health settings,
p.000529: includ- ing the ability of States and territories to exchange and share data.
p.000529: (2) NATIONAL INSTITUTES OF HEALTH.—The Director of the National Institutes of Health, acting through the
p.000529: Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
p.000529: this section, continue a pro- gram of research and development on the efficacy of new screening techniques
p.000529: and technology, including clinical studies of screening methods, studies on efficacy of intervention, and
p.000529: related research.
p.000529: (c) COORDINATION AND COLLABORATION.—
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
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p.000570: age and promote good nutrition and appropriate levels of phys- ical activity with respect to children or
p.000570: adolescents in local communities;
p.000570: (2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as
p.000570: State and local school departments, State departments of health, chronic disease directors, State directors of programs
p.000570: under section 17 of the Child Nutrition Act of 1966, 5-a-day coordinators, gov- ernors councils for
p.000570: physical activity and good nutrition, and State and local parks and recreation departments; and
p.000570: (3) the manner in which the applicant will evaluate the ef- fectiveness of the program carried out under this section.
p.000570: (c) USE OF FUNDS.—A State or political subdivision of a State shall use amount received under a grant under
p.000570: this section to—
p.000570: (1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to
p.000570: reduce inactivity and improve dietary choices among children and adolescents;
p.000570: (2) expand opportunities for physical activity programs in school- and community-based settings; and
p.000570: (3) develop, implement, and evaluate programs that pro- mote good eating habits and physical activity including
p.000570: oppor- tunities for children with cognitive and physical disabilities.
p.000570: (d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an amount not to exceed 10 percent of the amount
p.000570: appropriated for a fiscal year under subsection (h) to permit the Director of the Cen- ters for Disease
p.000570: Control and Prevention to—
p.000570: (1) provide States and political subdivisions of States with technical support in the development and
p.000570: implementation of programs under this section; and
p.000570: (2) disseminate information about effective strategies and interventions in preventing and treating obesity
p.000570: through the promotion of good nutrition and physical activity.
p.000570: (e) LIMITATION ON ADMINISTRATIVE COSTS.—Not to exceed 10 percent of the amount of a grant awarded to
p.000570: the State or political subdivision under subsection (a) for a fiscal year may be used by the State or
p.000570: political subdivision for administrative expenses.
p.000570: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000571: PUBLIC HEALTH SERVICE ACT
p.000571: Sec. 399Y
p.000571:
p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
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p.000663: payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38,
p.000663: United States Code, for nurses of the Department of Veterans Affairs.
p.000663: DEFINITIONS
p.000663: SEC. 409. ø284d¿ (a) HEALTH SERVICE RESEARCH.—For pur-
p.000663: poses of this title, the term ‘‘health services research’’ means re- search endeavors that study the impact
p.000663: of the organization, financ- ing and management of health services on the quality, cost, access to and outcomes of
p.000663: care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical
p.000663: condi- tions.
p.000663: (b) CLINICAL RESEARCH.—As used in this title, the term ‘‘clin- ical research’’ means patient oriented
p.000663: clinical research conducted with human subjects, or research on the causes and consequences
p.000663:
p.000663:
p.000663:
p.000663:
p.000663: January 30, 2020
p.000663: 10 Section 407 of the Public Health Service Act was repealed by section 104(b)(1)(C) of Public Law 109–482 (120 Stat.
p.000663: 3693).
p.000663: 11 See footnote 2 for section 403(5).
p.000663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000663: Sec. 409A PUBLIC HEALTH SERVICE ACT 664
p.000663:
p.000663: of disease in human populations involving material of human ori- gin (such as tissue specimens and cognitive
p.000663: phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient
p.000663: setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behav- ioral
p.000663: studies, outcomes research or health services research, or de- veloping new technologies, therapeutic
p.000663: interventions, or clinical trials.
p.000663: RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND RELATED BONE DISORDERS
p.000663: SEC. 409A. ø284e¿ (a) ESTABLISHMENT.—The Directors of the National Institute of Arthritis and
p.000663: Musculoskeletal and Skin Dis- eases, the National Institute on Aging, the National Institute of Dental
p.000663: Research, 12 and the National Institute of Diabetes and Di- gestive and Kidney Diseases, shall expand and
p.000663: intensify the pro- grams of such Institutes with respect to research and related ac- tivities concerning
p.000663: osteoporosis, Paget’s disease, and related bone disorders.
p.000663: (b) COORDINATION.—The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such
p.000663: subsection and consult with the Arthritis and Musculoskeletal Diseases Inter- agency Coordinating Committee and the
p.000663: Interagency Task Force on Aging Research.
p.000663: (c) INFORMATION CLEARINGHOUSE.—
p.000663: (1) IN GENERAL.—In order to assist in carrying out the pur- pose described in subsection (a), the Director of NIH shall
p.000663: pro- vide for the establishment of an information clearinghouse on osteoporosis and related bone disorders
p.000663: to facilitate and en- hance knowledge and understanding on the part of health pro- fessionals, patients, and the
p.000663: public through the effective dis- semination of information.
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p.001203: (D) the development of programs that increase the participation of academic centers of excellence in brain in-
p.001203:
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p.001203: January 30, 2020
p.001203: 3 Section 1303(a)(2) of Public Law 106–310 (114 Stat. 1138) provides that subparagraph (B) is amended by
p.001203: striking ‘‘acute injury’’ and inserting ‘‘acute brain injury’’. The amendment cannot be executed because the term
p.001203: to be struck does not appear in subparagraph (B). (Compare ‘‘acute injury’’ and ‘‘acute head injury’’.)
p.001203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001205: PUBLIC HEALTH SERVICE ACT
p.001205: Sec. 1261
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p.001205: jury treatment and rehabilitation research and training; and
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p.001205: (E) carrying out subparagraphs (A) through (D) with respect to cognitive disorders and neurobehavioral
p.001205: con- sequences arising from traumatic brain injury, including the development, modification, and evaluation of
p.001205: therapies and programs of rehabilitation toward reaching or restor- ing normal capabilities in areas such
p.001205: as reading, com- prehension, speech, reasoning, and deduction.
p.001205: (e) MECHANISMS OF SUPPORT.—In carrying out the Program, the Director, acting through the Directors of
p.001205: the agencies referred to in subsection (c)(1), may make grants to public and nonprofit en- tities, including
p.001205: designated trauma centers.
p.001205: (f) RESOURCES.—The Director shall assure the availability of appropriate resources to carry out the Program,
p.001205: including the plan established under subsection (b) (including the activities described in subsection (d)).
p.001205: (g) COORDINATING COMMITTEE.—
p.001205: (1) IN GENERAL.—There shall be established a Trauma Re- search Interagency Coordinating Committee (in this section re-
p.001205: ferred to as the ‘‘Coordinating Committee’’).
p.001205: (2) DUTIES.—The Coordinating Committee shall make rec- ommendations regarding—
p.001205: (A) the activities of the Program to be carried out by each of the agencies represented on the Committee and
p.001205: the amount of funds needed by each of the agencies for such activities; and
p.001205: (B) effective collaboration among the agencies in car- rying out the activities.
p.001205: (3) COMPOSITION.—The Coordinating Committee shall be composed of the Directors of each of the agencies
p.001205: that, under subsection (c), have responsibilities under the Program, and any other individuals who are
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p.001417: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001417: fiscal years 1989 and 1990 make an allotment for each State in an amount deter- mined in accordance with
p.001417: section 2408. The Secretary shall make payments each such fiscal year to each State from the allotment for the
p.001417: State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant
p.001417: to section 2407.
p.001417: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001417: unless the State in- volved agrees to expend the payments only for the purpose of pro- viding services in accordance
p.001417: with section 2402.
p.001417: (c) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this part:
p.001417: (1) The term ‘‘eligible individual’’ means an individual in- fected with the etiologic agent for acquired
p.001417: immune deficiency syndrome who either is medically dependent or chronically de- pendent.
p.001417: (2) The term ‘‘medically dependent’’ means, with respect to an individual, that the individual has been certified by a
p.001417: physi- cian as—
p.001417: (A) requiring the routine use of appropriate medical services (which may include home intravenous drug
p.001417: ther- apy) to prevent or compensate for the individual’s serious deterioration, arising from infection
p.001417: with the etiologic agent for acquired immune deficiency syndrome, of phys- ical health or cognitive
p.001417: function, and
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p.001417: January 30, 2020
p.001417: 1 See footnote at beginning of title XXIII.
p.001417:
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
p.001417: (3) The term ‘‘chronically dependent’’ means, with respect to an individual, that the individual has been
p.001417: certified by a physician as—
p.001417: (A) being unable to perform, because of physical or cognitive impairment (without substantial assistance
p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
p.001417: (C) day treatment or other partial hospitalization serv- ices,
p.001417: (D) home intravenous drug therapy (including pre- scription drugs administered intravenously as part of such
p.001417: therapy), and
p.001417: (E) routine diagnostic tests administered in the indi- vidual’s home,
p.001417: furnished pursuant to such plan of care; but
p.001417: (3) does not include, except as specifically provided in paragraph (2)—
p.001417: (A) diagnostic tests,
p.001417: (B) inpatient hospital services,
p.001417: (C) nursing facility services, and
p.001417: (D) prescription drugs.
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p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
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p.000197: the examination of contractor records).
p.000197: (iv) Section 3131 of title 40, United States Code (relating to bonds of contractors of public buildings or
p.000197: works).
p.000197: (v) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41
p.000197: U.S.C. 254(a)) (relating to contingent fees to middle- men).
p.000197: (vi) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962).
p.000197: (vii) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000197: appropriated funds for contracts with entities not meeting veterans employment reporting requirements).
p.000197: (C) INTERNAL CONTROLS TO BE INSTITUTED.—The Sec- retary shall institute appropriate internal controls for pro-
p.000197: curements that are under this paragraph, including re- quirements with regard to documenting the
p.000197: justification for use of the authority in this paragraph with respect to the procurement involved.
p.000197: (D) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this paragraph, the Secretary may not
p.000197: use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and
p.000197: open competition unless the Secretary determines that the mission of the BioShield Program under the Project
p.000197: Bio- Shield Act of 2004 would be seriously impaired without such a limitation.
p.000197: (2) PROCEDURES OTHER THAN FULL AND OPEN COMPETI- TION.—
p.000197:
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p.000197:
p.000197:
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p.000197:
p.000197:
p.000197: January 30, 2020
p.000197: (A) IN GENERAL.—In using the authority provided in section 303(c)(1) of title III of the Federal Property and
p.000197: Ad- ministrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive
p.000197: procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase
p.000197: ‘‘available from only one responsible source’’ in such section 303(c)(1) shall be deemed to mean ‘‘available
p.000197: from only one responsible source or only from a limited number of responsible sources’’.
p.000197: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000197:
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p.000197: Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 198
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p.000213: January 30, 2020
p.000213: U.S.C. 254d) (relating to the examination of contractor records).
p.000213: (dd) Section 3131 of title 40, United States Code (relating to bonds of contractors of public
p.000213: buildings or works).
p.000213: (ee) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000213: 254(a)) (relating to con- tingent fees to middlemen).
p.000213: (ff) Section 6002 of the Solid Waste Dis- posal Act (42 U.S.C. 6962).
p.000213: (gg) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000213: appropriated funds for contracts with entities not meeting veterans employment re- porting requirements).
p.000213: (III) INTERNAL CONTROLS TO BE ESTAB- LISHED.—The Secretary shall establish appro- priate
p.000213: internal controls for procurements made under this clause, including requirements with re- spect to documentation
p.000213: of the justification for the use of the authority provided under this para- graph with respect to the
p.000213: procurement involved.
p.000213: (IV) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this subpara- graph, the
p.000213: Secretary may not use the authority provided for under subclause (I) to conduct a pro- curement on a basis other
p.000213: than full and open com- petition unless the Secretary determines that the mission of the BioShield
p.000213: Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
p.000213: (iv) PROCEDURES OTHER THAN FULL AND OPEN COMPETITION.—
p.000213: (I) IN GENERAL.—In using the authority pro- vided in section 303(c)(1) of title III of the Federal Property and
p.000213: Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in
p.000213: the case of a procure- ment under this subsection, the phrase ‘‘available from only one responsible source’’
p.000213: in such section 303(c)(1) shall be deemed to mean ‘‘available from only one responsible source or only from a limited
p.000213: number of responsible sources’’.
p.000213: (II) RELATION TO OTHER AUTHORITIES.—The authority under subclause (I) is in addition to any other authority to
p.000213: use procedures other than com- petitive procedures.
p.000213: (III) APPLICABLE GOVERNMENT-WIDE REGULA- TIONS.—The Secretary shall implement this clause in accordance with
p.000213: government-wide regulations implementing such section 303(c)(1) (including re- quirements that offers be solicited
p.000213: from as many potential sources as is practicable under the cir-
p.000213: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000213:
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p.000213: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 214
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p.000743:
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p.000743:
p.000743: January 30, 2020
p.000743: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY BOARD
p.000743: SEC. 464D. ø285m–4¿ (a) The Secretary shall establish in the Institute the National Deafness and Other
p.000743: Communications Dis- orders Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000743: (b) The Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000743: follows:
p.000743: (1) The Secretary shall appoint—
p.000743: (A) twelve members from individuals who are sci- entists, physicians, and other health and rehabilitation
p.000743: professionals, who are not officers or employees of the United States, and who represent the specialties
p.000743: and dis- ciplines relevant to deafness and other communication dis- orders, including not less than two persons with a
p.000743: commu- nication disorder; and
p.000743: (B) six members from the general public who are knowledgeable with respect to such disorders, including
p.000743: not less than one person with a communication disorder and not less than one person who is a parent
p.000743: of an indi- vidual with such a disorder.
p.000743: Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in
p.000743: diagnoses and re- habilitation of communication disorders, education of the hear- ing, speech, or language
p.000743: impaired, public health, public infor- mation, community program development, occupational haz- ards to
p.000743: communications senses, or the aging process.
p.000743: (2) The following shall be ex officio members of each Advi- sory Board:
p.000743: (A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness
p.000743: and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the
p.000743: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000743: Health Affairs (or the designees of such officers).
p.000743: (B) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000743: sory Board to carry out its functions.
p.000743: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000743: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000743: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000743: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000743: engaged in the per- formance of their duties as members of the Board.
p.000743: (d) The term of office of an appointed member of the Advisory Board is four years, except that no term of
p.000743: office may extend be- yond the expiration of the Advisory Board. Any member appointed
p.000743: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000743:
p.000743:
p.000743:
p.000743:
p.000743:
p.000743:
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p.001371: determined to be reasonably nec- essary.
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 8 Effective October 1, 1988.
p.001371:
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
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p.001373: 1373
p.001373: PUBLIC HEALTH SERVICE ACT
p.001373: Sec. 2115
p.001373:
p.001373: (B) Subject to section 2116(a)(2), actual unreimbursable ex- penses incurred before the date of the judgment awarding
p.001373: such expenses which—
p.001373: (i) resulted from the vaccine-related injury for which the petitioner seeks compensation,
p.001373: (ii) were incurred by or on behalf of the person who suffered such injury, and
p.001373: (iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special
p.001373: edu- cation, vocational training and placement, case manage- ment services, counseling, emotional or behavioral
p.001373: therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and
p.001373: facilities deter- mined to be reasonably necessary.
p.001373: (2) In the event of a vaccine-related death, an award of
p.001373: $250,000 for the estate of the deceased.
p.001373: (3)(A) In the case of any person who has sustained a vac- cine-related injury after attaining the age
p.001373: of 18 and whose earning capacity is or has been impaired by reason of such per- son’s vaccine-related injury for
p.001373: which compensation is to be awarded, compensation for actual and anticipated loss of earn- ings determined in
p.001373: accordance with generally recognized actu- arial principles and projections.
p.001373: (B) In the case of any person who has sustained a vaccine- related injury before attaining the age of 18 and whose
p.001373: earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which
p.001373: compensation is to be awarded and whose vaccine-related injury is of sufficient severity to per- mit reasonable
p.001373: anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after
p.001373: attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of
p.001373: workers in the private, non-farm sector, less appropriate taxes and the av- erage cost of a health insurance
p.001373: policy, as determined by the Secretary.
p.001373: (4) For actual and projected pain and suffering and emo-
p.001373: tional distress from the vaccine-related injury, an award not to exceed $250,000.
p.001373: (b) VACCINES ADMINISTERED BEFORE THE EFFECTIVE DATE.— Compensation awarded under the Program to a
p.001373: petitioner under section 2111 for a vaccine-related injury or death associated with the administration of
p.001373: a vaccine before the effective date of this part 9 may include the compensation described in paragraphs (1)(A)
p.001373: and (2) of subsection (a) and may also include an amount, not to exceed a combined total of $30,000, for—
p.001373: (1) lost earnings (as provided in paragraph (3) of sub- section (a)),
p.001373: (2) pain and suffering (as provided in paragraph (4) of subsection (a)), and
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 9 Effective October 1, 1988.
p.001373:
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
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p.000001: section 319I or the Medical Reserve Corps established under section 2813, to provide health care
p.000001: services,
p.000001: shall be subject only to the State liability laws of the State in which such act or omission occurred,
p.000001: in the same manner and to the same extent as a similar health care professional who is a resi- dent of such State
p.000001: would be subject to such State laws, except with respect to the licensure, registration, and certification of such
p.000001: indi- vidual.
p.000001: (b) VOLUNTEER PROTECTION ACT.—Nothing in this section shall be construed to affect an individual’s right to
p.000001: protections under the Volunteer Protection Act of 1997.
p.000001: (c) PREEMPTION.—This section shall supersede the laws of any State that would subject a health care professional
p.000001: described in subsection (a) to the liability laws of any State other than the State liability laws to which such
p.000001: individual is subject pursuant to such subsection.
p.000001: (d) DEFINITIONS.—In this section:
p.000001: (1) The term ‘‘health care professional’’ means an indi- vidual licensed, registered, or certified under
p.000001: Federal or State laws or regulations to provide health care services.
p.000001: (2) The term ‘‘health care services’’ means any services provided by a health care professional, or by
p.000001: any individual working under the supervision of a health care professional, that relate to—
p.000001: (A) the diagnosis, prevention, or treatment of any human disease or impairment; or
p.000001: (B) the assessment or care of the health of human beings.
p.000001: (e) EFFECTIVE DATE.—
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 45 PUBLIC HEALTH SERVICE ACT Sec. 227
p.000001:
p.000001: (1) IN GENERAL.—This section shall take effect 90 days after the date of the enactment of the Pandemic
p.000001: and All-Haz- ards Preparedness and Advancing Innovation Act of 2019.
p.000001: (2) APPLICATION.—This section shall apply to a claim for harm only if the act or omission that caused
p.000001: such harm oc- curred on or after the effective date described in paragraph (1).
p.000001: ADMINISTRATION OF GRANTS IN CERTAIN MULTIGRANT PROJECTS
p.000001: SEC. 226. ø235¿ For the purpose of facilitating the administra- tion of, and expediting the carrying out of the
p.000001: purposes of, the pro- grams established by titles VII, VIII, and IX, and sections 304, 314(a), 314(b),
p.000001: 314(c), 314(d), and 314(e) of this Act in situations in which grants are sought or made under two or more of
p.000001: such pro- grams with respect to a single project, the Secretary is authorized to promulgate regulations—
p.000001: (1) under which the administrative functions under such programs with respect to such project will be
...

p.000017: or other cardiopulmonary functioning of the individual.
p.000017: (2) OTHER DEFINITIONS.—For purposes of this section:
p.000017: (A) The term ‘‘automated external defibrillator device’’ means a defibrillator device that—
p.000017: (i) is commercially distributed in accordance with the Federal Food, Drug, and Cosmetic Act;
p.000017: (ii) is capable of recognizing the presence or ab- sence of ventricular fibrillation, and is capable of
p.000017: de- termining without intervention by the user of the de- vice whether defibrillation should be performed;
p.000017: (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an
p.000017: individual; and
p.000017: (iv) in the case of a defibrillator device that may be operated in either an automated or a manual mode, is
p.000017: set to operate in the automated mode.
p.000017: (B)(i) The term ‘‘harm’’ includes physical, nonphysical, economic, and noneconomic losses.
p.000017: (ii) The term ‘‘economic loss’’ means any pecuniary loss resulting from harm (including the loss of earnings or
p.000017: other benefits related to employment, medical expense loss, replacement services loss, loss due to
p.000017: death, burial costs, and loss of business or employment opportunities) to the extent recovery for such loss is allowed
p.000017: under applica- ble State law.
p.000017: (iii) The term ‘‘noneconomic losses’’ means losses for physical and emotional pain, suffering,
p.000017: inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and
p.000017: companionship, loss of consortium (other than loss of domestic service), hedonic damages, injury to reputation and
p.000017: all other nonpecuniary losses of any kind or nature.
p.000017: PART C—SMALLPOX EMERGENCY PERSONNEL PROTECTION
p.000017: SEC. 261. ø239¿ GENERAL PROVISIONS.
p.000017: (a) DEFINITIONS.—For purposes of this part:
p.000017: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means a covered countermeasure as specified in a
p.000017: Declaration made pursuant to section 224(p).
p.000017: (2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’ means an individual—
p.000017: (A) who is a health care worker, law enforcement offi- cer, firefighter, security personnel, emergency medical per-
p.000017: sonnel, other public safety personnel, or support personnel for such occupational specialities;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
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p.000017:
p.000017: Sec. 261 PUBLIC HEALTH SERVICE ACT 60
p.000017:
p.000017: (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human
p.000017: Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary;
...

p.000225: (iv) any other publicly or privately funded pro- gram.
p.000225: (8) NONECONOMIC DAMAGES.—In an action under sub- section (d), any noneconomic damages may be awarded only
p.000225: in an amount directly proportional to the percentage of responsi-
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000225:
p.000225:
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p.000225:
p.000225: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 226
p.000225:
p.000225:
p.000225:
p.000225:
p.000225:
p.000225:
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p.000225:
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p.000225: January 30, 2020
p.000225:
p.000225: bility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term ‘‘noneconomic
p.000225: damages’’ means damages for losses for physical and emotional pain, suffering, inconvenience, physical
p.000225: impairment, mental anguish, disfigure- ment, loss of enjoyment of life, loss of society and companion- ship,
p.000225: loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
p.000225: (9) RULE 11 SANCTIONS.—Whenever a district court of the United States determines that there has been a
p.000225: violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court
p.000225: shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are respon- sible for
p.000225: the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the
p.000225: reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that
p.000225: is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter
p.000225: repetition of such conduct or comparable conduct by others similarly situated, and to compensate the
p.000225: party or parties injured by such conduct.
p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
...

p.000227: described in clause (i) or (ii); and
p.000227: (B)(i) approved or cleared under chapter V of the Fed- eral Food, Drug, and Cosmetic Act or licensed under
p.000227: sec- tion 351 of this Act;
p.000227: (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an
p.000227: exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; or
p.000227: (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and
p.000227: Cosmetic Act.
p.000227: (8) QUALIFIED PERSON.—The term ‘‘qualified person’’, when used with respect to the administration or use of a
p.000227: covered countermeasure, means—
p.000227: (A) a licensed health professional or other individual who is authorized to prescribe, administer, or
p.000227: dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered,
p.000227: or dis- pensed; or
p.000227: (B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
p.000227: (9) SECURITY COUNTERMEASURE.—The term ‘‘security coun- termeasure’’ has the meaning given such term in section 319F–
p.000227: 2(c)(1)(B).
p.000227: (10) SERIOUS PHYSICAL INJURY.—The term ‘‘serious phys- ical injury’’ means an injury that—
p.000227: (A) is life threatening;
p.000227: (B) results in permanent impairment of a body func- tion or permanent damage to a body structure; or
p.000227: (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or per-
p.000227: manent damage to a body structure.
p.000227: SEC. 319F–4. ø247d–6e¿ COVERED COUNTERMEASURE PROCESS.
p.000227: (a) ESTABLISHMENT OF FUND.—Upon the issuance by the Sec- retary of a declaration under section 319F–3(b), there
p.000227: is hereby es- tablished in the Treasury an emergency fund designated as the
p.000227:
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p.000227: January 30, 2020
p.000227: 23 Margin of clause (iii) so in law.
p.000227:
p.000227: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000229: PUBLIC HEALTH SERVICE ACT
p.000229: Sec. 319F–4
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p.000229: January 30, 2020
p.000229: ‘‘Covered Countermeasure Process Fund’’ for purposes of providing timely, uniform, and adequate compensation to
p.000229: eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure
...

p.000411: PREPARATION OF BIOLOGICAL PRODUCTS
p.000411: SEC. 352. ø263¿ (a) The Service may prepare for its own use any product described in section 351 and any
p.000411: product necessary to carrying out any of the purposes of section 301.
p.000411: (b) The Service may prepare any product described in section 351 for the use of other Federal departments or
p.000411: agencies, and pub- lic or private agencies and individuals engaged in work in the field of medicine when such product
p.000411: is not available from establishments licensed under such section.
p.000411: Subpart 2—Clinical Laboratories
p.000411:
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p.000411: January 30, 2020
p.000411:
p.000411: CERTIFICATION OF LABORATORIES
p.000411: SEC. 353. ø263a¿ (a) DEFINITION.—As used in this section, the term ‘‘laboratory’’ or ‘‘clinical laboratory’’ means a
p.000411: facility for the bi- ological, microbiological, serological, chemical, immuno- hematological,
p.000411: hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body
p.000411: for
p.000411: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000411:
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p.000411: Sec. 353 PUBLIC HEALTH SERVICE ACT 412
p.000411:
p.000411: the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or
p.000411: the assessment of the health of, human beings.
p.000411: (b) CERTIFICATE REQUIREMENT.—No person may solicit or ac- cept materials derived from the human body
p.000411: for laboratory exam- ination or other procedure unless there is in effect for the labora- tory a
p.000411: certificate issued by the Secretary under this section applica- ble to the category of examinations or
p.000411: procedures which includes such examination or procedure.
p.000411: (c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
p.000411: (1) IN GENERAL.—The Secretary may issue or renew a cer- tificate for a laboratory only if the laboratory meets
p.000411: the re- quirements of subsection (d).
p.000411: (2) TERM.—A certificate issued under this section shall be valid for a period of 2 years or such shorter period
p.000411: as the Sec- retary may establish.
p.000411: (d) REQUIREMENTS FOR CERTIFICATES.—
p.000411: (1) IN GENERAL.—A laboratory may be issued a certificate or have its certificate renewed if—
p.000411: (A) the laboratory submits (or if the laboratory is ac- credited under subsection (e), the accreditation body
p.000411: which accredited the laboratory submits), an application—
p.000411: (i) in such form and manner as the Secretary shall prescribe,
p.000411: (ii) that describes the characteristics of the labora- tory examinations and other procedures performed by the
p.000411: laboratory including—
p.000411: (I) the number and types of laboratory exami- nations and other procedures performed,
p.000411: (II) the methodologies for laboratory examina- tions and other procedures employed, and
p.000411: (III) the qualifications (educational back- ground, training, and experience) of the personnel directing
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p.000485: January 30, 2020
p.000485: agreements and information as the Secretary may require, in- cluding a description of how the entity will—
p.000485: (A) coordinate, as applicable, with existing Federal, State, and tribal programs related to Alzheimer’s
p.000485: disease and related dementias;
p.000485: (B) examine, evaluate, and promote evidence-based interventions for individuals with Alzheimer’s disease
p.000485: and related dementias, including underserved populations with such conditions, and those who provide care for such
p.000485: indi- viduals; and
p.000485: (C) prioritize activities relating to—
p.000485: (i) expanding efforts, as appropriate, to implement evidence-based practices to address Alzheimer’s dis- ease and
p.000485: related dementias, including through the training of State, local, and tribal public health offi- cials
p.000485: and other health professionals on such practices;
p.000485: (ii) supporting early detection and diagnosis of Alzheimer’s disease and related dementias;
p.000485: (iii) reducing the risk of potentially avoidable hos- pitalizations of individuals with Alzheimer’s disease and
p.000485: related dementias;
p.000485: (iv) reducing the risk of cognitive decline and cog- nitive impairment associated with Alzheimer’s disease and related
p.000485: dementias;
p.000485: (v) enhancing support to meet the needs of care- givers of individuals with Alzheimer’s disease and re-
p.000485: lated dementias;
p.000485: (vi) reducing health disparities related to the care and support of individuals with Alzheimer’s disease and
p.000485: related dementias;
p.000485: (vii) supporting care planning and management for individuals with Alzheimer’s disease and related
p.000485: dementias; and
p.000485: (viii) supporting other relevant activities identified by the Secretary or the Director of the Centers for Dis- ease
p.000485: Control and Prevention, as appropriate.
p.000485: (3) CONSIDERATIONS.—In awarding grants, contracts, and cooperative agreements under this subsection, the
p.000485: Secretary shall consider, among other factors, whether the entity—
p.000485: (A) provides services to rural areas or other under- served populations;
p.000485: (B) is able to build on an existing infrastructure of services and public health research; and
p.000485: (C) has experience with providing care or caregiver support, or has experience conducting research related
p.000485: to Alzheimer’s disease and related dementias.
p.000485: (4) DISTRIBUTION OF AWARDS.—In awarding grants, con- tracts, or cooperative agreements under this
p.000485: subsection, the Secretary, to the extent practicable, shall ensure equitable dis- tribution of awards based on
p.000485: geographic area, including consid- eration of rural areas, and the burden of the disease within
p.000485: sub-populations.
p.000485: (5) DATA REPORTING AND PROGRAM OVERSIGHT.—With re- spect to a grant, contract, or cooperative agreement
p.000485: awarded
p.000485: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000485:
p.000485:
p.000485:
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p.000565: recommenda-
p.000565: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000565: Sec. 399V–5 PUBLIC HEALTH SERVICE ACT 566
p.000565:
p.000565: tions of each respective Commission based on independent re- views conducted under paragraphs (1) and
p.000565: (2), including an analysis of the impact of the alternatives reviewed on the effi- ciency and effectiveness of the
p.000565: respective programs.
p.000565: (i) OPTION TO PROVIDE FOR INITIAL PLANNING GRANTS.—Of the funds appropriated pursuant to subsection (k),
p.000565: the Secretary may use a portion not to exceed $500,000 per State to provide planning grants to such States for the
p.000565: development of demonstration project applications meeting the criteria described in subsection (c). In se- lecting
p.000565: States to receive such planning grants, the Secretary shall give preference to those States in which
p.000565: State law at the time of the application would not prohibit the adoption of an alternative to current tort
p.000565: litigation.
p.000565: (j) DEFINITIONS.—In this section:
p.000565: (1) HEALTH CARE SERVICES.—The term ‘‘health care serv- ices’’ means any services provided by a health care
p.000565: provider, or by any individual working under the supervision of a health care provider, that relate to—
p.000565: (A) the diagnosis, prevention, or treatment of any human disease or impairment; or
p.000565: (B) the assessment of the health of human beings.
p.000565: (2) HEALTH CARE ORGANIZATION.—The term ‘‘health care organization’’ means any individual or entity which is
p.000565: obligated to provide, pay for, or administer health benefits under any health plan.
p.000565: (3) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any individual or entity—
p.000565: (A) licensed, registered, or certified under Federal or State laws or regulations to provide health care
p.000565: services; or
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p.000565: (B) required to be so licensed, registered, or certified but that is exempted by other statute or regulation.
p.000565: (k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $50,000,000
p.000565: for the 5- fiscal year period beginning with fiscal year 2011.
p.000565: (l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO TORT LITIGATION.—Nothing in this section shall
p.000565: be construed to limit any prior, current, or future efforts of any State to establish any alternative to
p.000565: tort litigation.
p.000565: (m) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as limiting states’ authority over or
p.000565: responsibility for their state justice systems.
p.000565: SEC. 399V–5. ø280g–16¿ FOOD SAFETY INTEGRATED CENTERS OF EX- CELLENCE.
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p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
p.001027: contract under subsection (a) shall be 5 years. The provision of such payments shall be subject to annual
p.001027: approval by the Secretary and subject to the availability of appropriations for the fiscal year involved to
p.001027: make the payments.
p.001027: (f) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out subsections (a) and (b), there is
p.001027: authorized to be ap- propriated $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of
p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
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p.001095: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001095: Sec. 836 PUBLIC HEALTH SERVICE ACT 1096
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p.001095: January 30, 2020
p.001095:
p.001095: 2011. After fiscal year 2011, such amounts shall be adjusted to pro- vide for a cost-of-attendance increase for
p.001095: the yearly loan rate and the aggregate of the loans.
p.001095: (b) Loans from any such student loan fund by any school shall be made on such terms and conditions as the
p.001095: school may deter- mine; subject, however, to such conditions, limitations, and require- ments as the Secretary
p.001095: may prescribe (by regulation or in the agreement with the school) with a view to preventing impairment
p.001095: of the capital of such fund to the maximum extent practicable in the light of the objective of
p.001095: enabling the student to complete his course of study; and except that—
p.001095: (1) such a loan may be made only to a student who (A) is in need of the amount of the loan to pursue a full-time or
p.001095: half- time course of study at the school leading to a baccalaureate or associate degree in nursing or an
p.001095: equivalent degree, or a di- ploma in nursing, or a graduate degree in nursing, (B) is capa- ble, in the opinion of the
p.001095: school, of maintaining good standing in such course of study, and (C) with respect to any student en- rolling in the
p.001095: school after June 30, 2000, is of financial need (as defined in regulations issued by the Secretary);
p.001095: (2) such a loan shall be repayable in equal or graduated periodic installments (with the right of the
p.001095: borrower to accel- erate repayment) over the ten-year period which begins nine months after the student
p.001095: ceases to pursue a full-time or half- time course of study at a school of nursing, excluding from such
p.001095: 10-year period all (A) periods (up to three years) of (i) ac- tive duty performed by the borrower as a member
p.001095: of a uni- formed service, or (ii) service as a volunteer under the Peace Corps Act, (B) periods (up to ten
p.001095: years) during which the bor- rower is pursuing a full-time or half-time course of study at a collegiate school of
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p.001369: (2) A petitioner may be considered to have suffered a resid- ual seizure disorder if the petitioner did not suffer a
p.001369: seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit
p.001369: before the first seizure or convulsion after the administration of the vaccine involved and if—
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p.001369: (A) in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure
p.001369: or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions
p.001369: occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a
p.001369: fever of less than 102 degrees Fahrenheit, and
p.001369: (B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after
p.001369: administration of the vaccine and 2 or more seizures or convulsions oc- curred within 1 year after the
p.001369: administration of the vac- cine which were unaccompanied by fever or accompanied by a fever of less than 102
p.001369: degrees Fahrenheit.
p.001369: (3)(A) The term ‘‘encephalopathy’’ means any significant acquired abnormality of, or injury to, or impairment of
p.001369: function of the brain. Among the frequent manifestations of encephalopathy are focal and
p.001369: diffuse neurologic signs, in- creased intracranial pressure, or changes lasting at least 6 hours in
p.001369: level of consciousness, with or without convulsions. The neurological signs and symptoms of encephalopathy
p.001369: may be temporary with complete recovery, or may result in various degrees of permanent impairment. Signs and
p.001369: symptoms such as high pitched and unusual screaming, persistent unconsolable crying, and
p.001369: bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of
p.001369: encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram.
p.001369: (B) If in a proceeding on a petition it is shown by a prepon- derance of the evidence that an encephalopathy was caused
p.001369: by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be
p.001369: considered to be a condition set forth in the table. If at the time a judgment is entered on a
p.001369: petition filed under section 2111 for a vaccine-related injury or death it is not possible to determine the cause, by a
p.001369: preponder- ance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition
p.001369: set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the
p.001369: table, the court shall consider the entire med- ical record.
p.001369: (4) For purposes of paragraphs (2) and (3), the terms ‘‘sei- zure’’ and ‘‘convulsion’’ include grand mal, petit
p.001369: mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a provision of the table to
p.001369: which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d), such paragraph
p.001369: shall not apply to such provision after the effective date of the
p.001369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
p.001417: (3) The term ‘‘chronically dependent’’ means, with respect to an individual, that the individual has been
p.001417: certified by a physician as—
p.001417: (A) being unable to perform, because of physical or cognitive impairment (without substantial assistance
p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
p.001417: (C) day treatment or other partial hospitalization serv- ices,
p.001417: (D) home intravenous drug therapy (including pre- scription drugs administered intravenously as part of such
p.001417: therapy), and
p.001417: (E) routine diagnostic tests administered in the indi- vidual’s home,
p.001417: furnished pursuant to such plan of care; but
p.001417: (3) does not include, except as specifically provided in paragraph (2)—
p.001417: (A) diagnostic tests,
p.001417: (B) inpatient hospital services,
p.001417: (C) nursing facility services, and
p.001417: (D) prescription drugs.
p.001417: SEC. 2402. ø300dd–1¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
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p.001665: 1665
p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: January 30, 2020
p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
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Health / Drug Dependence

Searching for indicator dependence:

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p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
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p.000001: January 30, 2020
p.000001: 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were
p.000001: all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan
p.000001: abolished the National Institutes of Health as an agency, it did not abolish the individual research
p.000001: institutes.
p.000001: In 1985, Public Law 99–158 added title IV of this Act, which provides that the National Insti- tutes of Health is an
p.000001: agency of the Public Health Service. See section 401(a).
p.000001: Other laws have established additional agencies within the Service. Section 501(a) of this Act provides that the
p.000001: Substance Abuse and Mental Health Services Administration is an agency of the Service. Section 901(a) establishes
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p.000017: MONEY COLLECTED FOR CARE OF PATIENTS
p.000017: SEC. 233. ø238b¿ Money collected as provided by law for ex- penses incurred in the care and treatment
p.000017: of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts
p.000017: received from any executive department on ac- count of care and treatment of pay patients, shall be
p.000017: covered into the appropriation from which the expenses of such care and treat- ment were paid.
p.000017: TRANSPORTATION OF REMAINS OF OFFICERS
p.000017: SEC. 234. ø238c¿ Appropriations available for traveling ex- penses of the Service shall be available for
p.000017: meeting the cost of preparation for burial and of transportation to the place of burial of remains of
p.000017: commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations
p.000017: available for carrying out the provisions of this Act shall also be available for the payment of such
p.000017: expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may
p.000017: be authorized under other provisions of law.
p.000017: GRANTS TO FEDERAL INSTITUTIONS
p.000017: SEC. 235. ø238d¿ Appropriations to the Public Health Service available under this Act for research,
p.000017: training, or demonstration project grants or for grants to expand existing treatment and re- search
p.000017: programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations
p.000017: under title VI of the Mental Health Systems Act shall also be available, on the same terms and conditions as
p.000017: apply to non-Federal institutions, for grants for the same purpose to Federal institutions, except that grants
p.000017: to such Federal institutions may be funded at 100 per cen- tum of the costs.
p.000017: TRANSFER OF FUNDS
p.000017: SEC. 236. ø238e¿ For the purpose of any reorganization under section 202, the Secretary, with the approval of the
p.000017: Director of the Bureau of the Budget, 18 is authorized to make such transfers of funds between
p.000017: appropriations as may be necessary for the continu- ance of transferred functions.
p.000017:
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p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 237 PUBLIC HEALTH SERVICE ACT 52
p.000017:
p.000017: AVAILABILITY OF APPROPRIATIONS
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p.001337: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001337: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001337: not be included in determining the amount of such contributions.
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001339: 1339
p.001339: PUBLIC HEALTH SERVICE ACT
p.001339: Sec. 1976
p.001339:
p.001339: (e) DURATION OF SUPPORT.—The period during which payments may be made for a project under subsection (a) may
p.001339: be not less than 3 years nor more than 5 years.
p.001339: (f) AUTHORIZATION OF APPROPRIATION.—
p.001339: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated such
p.001339: sums as may be necessary for each of the fiscal years 2001, 2002 and 2003.
p.001339: (2) ALLOCATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall
p.001339: be expended to support data infrastructure development for mental health and 50 percent shall be expended
p.001339: to support data infrastruc- ture development for substance abuse.
p.001339:
p.001339: Subpart II—Interim Maintenance Treatment of Narcotics Dependence
p.001339:
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p.001339: January 30, 2020
p.001339: SEC. 1976. ø300y–11¿ INTERIM MAINTENANCE TREATMENT.
p.001339: (a) REQUIREMENT REGARDING SECRETARY.—Subject to the fol- lowing subsections of this section, for the
p.001339: purpose of reducing the incidence of the transmission of HIV disease pursuant to the intra- venous abuse of heroin
p.001339: or other morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or
p.001339: nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs—
p.001339: (1) to dispense methadone for treatment purposes to indi- viduals who—
p.001339: (A) meet the conditions for admission to such pro- grams that dispense methadone as part of
p.001339: comprehensive treatment for such dependence; and
p.001339: (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity
p.001339: of the programs, will not gain such admission until 14 or more days after seeking admission to the programs;
p.001339: and
p.001339: (2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in
p.001339: which the individuals are waiting for admission to programs of com- prehensive treatment.
p.001339: (b) INAPPLICABILITY OF REQUIREMENT IN CERTAIN CIR-
p.001339: CUMSTANCES.—
p.001339: (1) IN GENERAL.—The requirement established in sub- section (a) for the Secretary does not apply if any or
p.001339: all of the following conditions are met:
p.001339: (A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease
p.001339: pursuant to the intravenous abuse of drugs is minimal.
p.001339: (B) The preponderance of scientific research indicates that the medically supervised dispensing of
p.001339: methadone is not an effective method of reducing the extent of depend- ence on heroin and other morphine-like
p.001339: drugs.
p.001339: (C) The preponderance of available data indicates that, of treatment programs that dispense methadone
p.001339: as part of comprehensive treatment, a substantial majority
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001339:
p.001339:
p.001339:
p.001339:
p.001339:
p.001339:
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p.001339: expiration of the 180- day period beginning on the date of the enactment of the ADAMHA Reorganization Act
p.001339: 20. If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued
p.001339: on March 2, 1989, with respect to part 291 of title 21, Code of Federal Regulations (docket numbered
p.001339: 88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and
p.001339: the provisions of para- graph (3) of this subsection are deemed to be incorporated into such rule.
p.001339: (d) DEFINITIONS.—For purposes of this section:
p.001339:
p.001339:
p.001339:
p.001339: January 30, 2020
p.001339: 20 Enacted July 10, 1992.
p.001339:
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: 1341
p.001341: PUBLIC HEALTH SERVICE ACT
p.001341: Sec. 2001
p.001341:
p.001341: (1) The term ‘‘interim maintenance services’’ means the provision of methadone in a treatment program under the
p.001341: cir- cumstances described in paragraphs (1) and (2) of subsection (a).
p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
p.001341: (3) The term ‘‘treatment program’’ means a public or non- profit private program of treatment for
p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
p.001341:
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
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Searching for indicator dependency:

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p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
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p.000017: January 30, 2020
p.000017: NARCOTICS
p.000017: SEC. 302. ø242¿ (a) In carrying out the purposes of section 301 with respect to drugs the use or misuse of
p.000017: which might result in drug abuse or dependency, the studies and investigations author- ized therein shall
p.000017: include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further
p.000017: include the quantities of crude opium, coca leaves, and their salts, deriva- tives, and preparations, and
p.000017: other drugs subject to control under the Controlled Substances Act and Controlled Substances Import and
p.000017: Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific
p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000753: (3) other matters determined appropriate by the Director.
p.000753: Subpart 17—National Institute of Nursing Research
p.000753: PURPOSE OF THE INSTITUTE
p.000753: SEC. 464V. ø285q¿ The general purpose of the National Insti- tute of Nursing Research (in this subpart referred
p.000753: to as the ‘‘Insti- tute’’) is the conduct and support of, and dissemination of informa- tion respecting, basic and
p.000753: clinical nursing research, training, and other programs in patient care research.
p.000753:
p.000753:
p.000753:
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p.000753:
p.000753: January 30, 2020
p.000753: SPECIFIC AUTHORITIES
p.000753: SEC. 464W. ø285q–1¿ To carry out section 464V, the Director of the Institute may provide research training and
p.000753: instruction and establish, in the Institute and other nonprofit institutions, research
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000753:
p.000753:
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p.000753:
p.000755: 755
p.000755: PUBLIC HEALTH SERVICE ACT
p.000755: Sec. 464X
p.000755:
p.000755: traineeships and fellowships in the study and investigation of the prevention of disease, health promotion,
p.000755: and the nursing care of in- dividuals with and the families of individuals with acute and chronic illnesses.
p.000755: The Director of the Institute may provide individ- uals receiving such training and instruction or such traineeships or
p.000755: fellowships with such stipends and allowances (including amounts for travel and subsistence and dependency
p.000755: allowances) as the Di- rector determines necessary. The Director may make grants to non- profit institutions to
p.000755: provide such training and instruction and traineeships and fellowships.
p.000755: ADVISORY COUNCIL
p.000755: SEC. 464X. ø285q–2¿ (a)(1) The Secretary shall appoint an ad- visory council for the Institute which shall
p.000755: advise, assist, consult with, and make recommendations to the Secretary and the Director of the Institute on
p.000755: matters related to the activities carried out by and through the Institute and the policies respecting
p.000755: such activi- ties.
p.000755: (2) The advisory council for the Institute may recommend to the Secretary acceptance, in accordance with
p.000755: section 2701, 45 of con- ditional gifts for study, investigations, and research and for the ac- quisition of grounds
p.000755: or construction, equipping, or maintenance of facilities for the Institute.
p.000755: (3) The advisory council for the Institute—
p.000755: (A)(i) may make recommendations to the Director of the Institute respecting research conducted at the
p.000755: Institute,
p.000755: (ii) may review applications for grants and cooperative agreements for research or training and recommend
p.000755: for ap- proval applications for projects which show promise of making valuable contributions to human knowledge, and
p.000755: (iii) may review any grant, contract, or cooperative agree- ment proposed to be made or entered into by the
p.000755: Institute;
p.000755: (B) may collect, by correspondence or by personal inves- tigation, information as to studies which are
p.000755: being carried on in the United States or any other country as to the diseases, disorders, or other
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p.000789:
p.000789:
p.000791: 791
p.000791: PUBLIC HEALTH SERVICE ACT
p.000791: Sec. 487
p.000791:
p.000791: (3) No grant may be made under subsection (a)(1)(B) unless an application therefor has been submitted to and
p.000791: approved by the Secretary. Such application shall be in such form, submitted in such manner, and contain
p.000791: such information, as the Secretary may by regulation prescribe. Subject to the provisions of this section
p.000791: (other than paragraph (1)), Ruth L. Kirschstein National Research Service Awards made under a grant under
p.000791: subsection (a)(1)(B) shall be made in accordance with such regulations as the Secretary shall prescribe.
p.000791: (4) The period of any Ruth L. Kirschstein National Research Service Award made to any individual under
p.000791: subsection (a) may not exceed—
p.000791: (A) five years in the aggregate for pre-doctoral training;
p.000791: and
p.000791: (B) three years in the aggregate for post-doctoral training;
p.000791:
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p.000791: January 30, 2020
p.000791: unless the Secretary for good cause shown waives the application of such limit to such individual.
p.000791: (5) Ruth L. Kirschstein National Research Service Awards shall provide for such stipends, tuition, fees,
p.000791: and allowances (in- cluding travel and subsistence expenses and dependency allow- ances), adjusted
p.000791: periodically to reflect increases in the cost of liv- ing, for the recipients of the awards as the
p.000791: Secretary may deem necessary. A Ruth L. Kirschstein National Research Service Award made to an individual for
p.000791: research or research training at a non- Federal public or nonprofit private institution shall also provide for
p.000791: payments to be made to the institution for the cost of support serv- ices (including the cost of faculty
p.000791: salaries, supplies, equipment, general research support, and related items) provided such indi- vidual by
p.000791: such institution. The amount of any such payments to any institution shall be determined by the Secretary and
p.000791: shall bear a direct relationship to the reasonable costs of the institution for establishing and
p.000791: maintaining the quality of its biomedical and be- havioral research and training programs.
p.000791: (c)(1) Each individual who is awarded a Ruth L. Kirschstein National Research Service Award for postdoctoral
p.000791: research training shall, in accordance with paragraph (3), engage in research train- ing, research, or
p.000791: teaching that is health-related (or any combina- tion thereof) for the period specified in paragraph (2).
p.000791: Such period shall be served in accordance with the usual patterns of scientific employment.
p.000791: (2)(A) The period referred to in paragraph (1) is 12 months, or one month for each month for which the
p.000791: individual involved re- ceives a Ruth L. Kirschstein National Research Service Award for postdoctoral
p.000791: research training, whichever is less.
p.000791: (B) With respect to postdoctoral research training, in any case in which an individual receives a Ruth L. Kirschstein
...

p.000889: for each of fiscal years 2018 through 2022.
p.000889: SEC. 520E–4. ø290bb-36d¿ TREATMENT REFERRAL ROUTING SERVICE.
p.000889: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Treatment
p.000889: Referral Routing Service (referred to in this section as the ‘‘Routing Service’’) to as- sist individuals and
p.000889: families in locating mental and substance use disorders treatment providers.
p.000889: (b) ACTIVITIES OF THE SECRETARY.—To maintain the Routing Service, the activities of the Assistant
p.000889: Secretary shall include ad- ministering—
p.000889: (1) a nationwide, telephone number providing year-round access to information that is updated on a
p.000889: regular basis re- garding local behavioral health providers and community- based organizations in a
p.000889: manner that is confidential, without requiring individuals to identify themselves, is in languages that
p.000889: include at least English and Spanish, and is at no cost to the individual using the Routing Service; and
p.000889: (2) an Internet website to provide a searchable, online treatment services locator of behavioral health
p.000889: treatment pro- viders and community-based organizations, which shall include information on the name, location,
p.000889: contact information, and basic services provided by such providers and organizations.
p.000889: (c) REMOVING PRACTITIONER CONTACT INFORMATION.—In the event that the Internet website described in
p.000889: subsection (b)(2) con- tains information on any qualified practitioner that is certified to prescribe
p.000889: medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act, the
p.000889: Assistant Sec- retary—
p.000889:
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p.000889: January 30, 2020
p.000889: (1) shall provide an opportunity to such practitioner to have the contact information of the practitioner
p.000889: removed from the website at the request of the practitioner; and
p.000889: (2) may evaluate other methods to periodically update the information displayed on such website.
p.000889: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prevent the Assistant Secretary from
p.000889: using any unob- ligated amounts otherwise made available to the Administration to maintain the Routing Service.
p.000889: SEC. 520F. ø290bb–37¿ STRENGTHENING COMMUNITY CRISIS RE- SPONSE SYSTEMS.
p.000889: (a) IN GENERAL.—The Secretary shall award competitive grants to—
p.000889: (1) State and local governments and Indian tribes and trib- al organizations, to enhance community-based crisis
p.000889: response systems; or
p.000889: (2) States to develop, maintain, or enhance a database of beds at inpatient psychiatric facilities, crisis
p.000889: stabilization units, and residential community mental health and residential sub- stance use disorder treatment
p.000889: facilities, for adults with a seri- ous mental illness, children with a serious emotional disturb- ance, or
p.000889: individuals with a substance use disorder.
p.000889: (b) APPLICATIONS.—
...

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p.001061: January 30, 2020
p.001061:
p.001061: teaching facility of the school that is participating in the pro- gram with such center; and
p.001061: (4) will assess the health personnel needs of the area to be served by the center and assist in the planning
p.001061: and develop- ment of training programs to meet such needs.
p.001061: SEC. 767. ø295b¿ PUBLIC HEALTH TRAINEESHIPS.
p.001061: (a) IN GENERAL.—The Secretary may make grants to accred- ited schools of public health, and to other
p.001061: public or nonprofit pri- vate institutions accredited for the provision of graduate or special- ized training in
p.001061: public health, for the purpose of assisting such schools and institutions in providing traineeships to
p.001061: individuals de- scribed in subsection (b)(3).
p.001061: (b) CERTAIN REQUIREMENTS.—
p.001061: (1) AMOUNT.—The amount of any grant under this section shall be determined by the Secretary.
p.001061: (2) USE OF GRANT.—Traineeships awarded under grants made under subsection (a) shall provide for tuition
p.001061: and fees and such stipends and allowances (including travel and sub- sistence expenses and dependency
p.001061: allowances) for the trainees as the Secretary may deem necessary.
p.001061: (3) ELIGIBLE INDIVIDUALS.—The individuals referred to in subsection (a) are individuals who are pursuing a
p.001061: course of study in a health professions field in which there is a severe shortage of health professionals
p.001061: (which fields include the fields of epidemiology, environmental health, biostatistics, toxicology, nutrition, and
p.001061: maternal and child health).
p.001061: SEC. 768. ø295c¿ PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAIN- ING GRANT PROGRAM.
p.001061: (a) GRANTS.—The Secretary, acting through the Administrator of the Health Resources and Services
p.001061: Administration and in con- sultation with the Director of the Centers for Disease Control and Prevention,
p.001061: shall award grants to, or enter into contracts with, eli- gible entities to provide training to graduate medical
p.001061: residents in preventive medicine specialties.
p.001061: (b) ELIGIBILITY.—To be eligible for a grant or contract under subsection (a), an entity shall be—
p.001061: (1) an accredited school of public health or school of medi- cine or osteopathic medicine;
p.001061: (2) an accredited public or private nonprofit hospital;
p.001061: (3) a State, local, or tribal health department; or
p.001061: (4) a consortium of 2 or more entities described in para- graphs (1) through (3).
p.001061: (c) USE OF FUNDS.—Amounts received under a grant or con- tract under this section shall be used to—
p.001061: (1) plan, develop (including the development of curricula), operate, or participate in an accredited residency
p.001061: or internship program in preventive medicine or public health;
p.001061: (2) defray the costs of practicum experiences, as required in such a program; and
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p.001063: (2) to assist accredited programs health administration in the development or improvement of programs to
p.001063: prepare stu- dents for employment with public or nonprofit private entities.
p.001063: (b) RELEVANT PROGRAMS.—The program referred to in sub- section (a) is an accredited program in health
p.001063: administration, hos- pital administration, or health policy analysis and planning, which program is accredited by a
p.001063: body or bodies approved for such pur- pose by the Secretary of Education and which meets such other
p.001063: quality standards as the Secretary of Health and Human Services by regulation may prescribe.
p.001063: (c) PREFERENCE IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give preference to
p.001063: qualified ap- plicants that meet the following conditions:
p.001063: (1) Not less than 25 percent of the graduates of the appli- cant are engaged in full-time practice settings in
p.001063: medically un- derserved communities.
p.001063: (2) The applicant recruits and admits students from medi- cally underserved communities.
p.001063: (3) For the purpose of training students, the applicant has established relationships with public and nonprofit
p.001063: providers of health care in the community involved.
p.001063: (4) In training students, the applicant emphasizes employ- ment with public or nonprofit private entities.
p.001063: (d) CERTAIN PROVISIONS REGARDING TRAINEESHIPS.—
p.001063: (1) USE OF GRANT.—Traineeships awarded under grants made under subsection (a) shall provide for tuition
p.001063: and fees and such stipends and allowances (including travel and sub- sistence expenses and dependency
p.001063: allowances) for the trainees as the Secretary may deem necessary.
p.001063: (2) PREFERENCE FOR CERTAIN STUDENTS.—Each entity ap- plying for a grant under subsection (a) for
p.001063: traineeships shall assure to the satisfaction of the Secretary that the entity will give priority to
p.001063: awarding the traineeships to students who demonstrate a commitment to employment with public or non- profit
p.001063: private entities in the fields with respect to which the traineeships are awarded.
p.001063: SEC. 770. ø295e¿ AUTHORIZATION OF APPROPRIATIONS.
p.001063: (a) IN GENERAL.—For the purpose of carrying out this subpart, there is authorized to be appropriated $43,000,000
p.001063: for fiscal year
p.001063: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001063:
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p.001063:
p.001063: Sec. 775 PUBLIC HEALTH SERVICE ACT 1064
p.001063:
p.001063: 2011, and such sums as may be necessary for each of the fiscal years 2012 through 2015.
p.001063: (b) LIMITATION REGARDING CERTAIN PROGRAM.—In obligating amounts appropriated under subsection (a), the
p.001063: Secretary may not obligate more than 30 percent for carrying out section 767.
p.001063: Subpart 3—Recruitment and Retention Programs
p.001063:
p.001063: SEC. 775. ø295f¿ INVESTMENT IN TOMORROW’S PEDIATRIC HEALTH CARE WORKFORCE.
p.001063: (a) ESTABLISHMENT.—The Secretary shall establish and carry out a pediatric specialty loan repayment program under
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p.001235: January 30, 2020
p.001235: TRAINING AND TECHNICAL ASSISTANCE
p.001235: SEC. 1317. ø300e–16¿ (a)(1) The Secretary shall establish a National Health Maintenance Organization Intern
p.001235: Program (here- inafter in this subsection referred to as the ‘‘Program’’) for the pur- pose of providing training
p.001235: to individuals to become administrators and medical directors of health maintenance organizations or to as- sume
p.001235: other managerial positions with health maintenance organi- zations. Under the Program the Secretary may directly
p.001235: provide in- ternships for such training and may make grants to or enter into contracts with health
p.001235: maintenance organizations and other entities to provide such internships.
p.001235: (2) No internship may be provided by the Secretary and no grant may be made or contract entered into
p.001235: by the Secretary for the provision of internships unless an application therefor has been submitted to and
p.001235: approved by the Secretary. Such an application shall be in such form and contain such information, and
p.001235: be sub- mitted to the Secretary in such manner, as the Secretary shall pre- scribe. Section 1306 does not apply
p.001235: to an application submitted under this section.
p.001235: (3) Internships under the Program shall provide for such sti- pends and allowances (including travel and
p.001235: subsistence expenses and dependency allowances) for the recipients of the internships as the Secretary deems
p.001235: necessary. An internship provided an indi- vidual for training at a health maintenance organization or
p.001235: any other entity shall also provide for payments to be made to the orga- nization or other entity for the cost
p.001235: of support services (including the cost of salaries, supplies, equipment, and related items) pro- vided
p.001235: such individual by such organization or other entity. The amount of any such payments to any
p.001235: organization or other entity shall be determined by the Secretary and shall bear a direct rela- tionship
p.001235: to the reasonable costs of the organization or other entity for establishing and maintaining its training programs.
p.001235: (4) Payments under grants under the Program may be made in advance or by way of reimbursement, and at such
p.001235: intervals and on such conditions, as the Secretary finds necessary.
p.001235: (b) The Secretary shall provide technical assistance (1) to enti- ties intending to become a qualified health
p.001235: maintenance organiza- tion within the meaning of section 1310(d), and (2) to health main-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001235: Sec. 1318 PUBLIC HEALTH SERVICE ACT 1236
p.001235:
p.001235: tenance organizations. The Secretary may provide such technical assistance through grants to public and
p.001235: nonprofit private entities and contracts with public and private entities.
...

p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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Health / Drug Usage

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p.000001: January 30, 2020
p.000001: DEFINITIONS
p.000001: SEC. 2. ø201¿ When used in this Act—
p.000001: (a) The term ‘‘Service’’ means the Public Health Service;
p.000001: (b) The term ‘‘Surgeon General’’ means the Surgeon General of the Public Health Service;
p.000001: (c) Unless the context otherwise requires, the term ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.000001: (d) The term ‘‘regulations’’, except when otherwise specified, means rules and regulations made by the
p.000001: Surgeon General with the approval of the Secretary;
p.000001: (e) The term ‘‘executive department’’ means any executive de- partment, agency, or independent
p.000001: establishment of the United States or any corporation wholly owned by the United States;
p.000001: (f) Except as provided in sections 314(g)(4)(B), 318(c)(1), 331(h)(3), 335(5), 361(d), 701(9),
p.000001: 1002(c), 1401(13), 1531(1), and 1633(1), the term ‘‘State’’ includes, in addition to the several
p.000001: States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the
p.000001: Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.
p.000001: (g) The term ‘‘possession’’ includes, among other possessions, Puerto Rico and the Virgin Islands;
p.000001: (h) øRepealed.¿
p.000001: (i) The term ‘‘vessel’’ includes every description of watercraft or other artificial contrivance used, or capable
p.000001: of being used, as a means of transportation on water, exclusive of aircraft and amphib- ious contrivances;
p.000001: (j) The term ‘‘habit-forming narcotic drug’’ or ‘‘narcotic’’ means opium and coca leaves and the several alkaloids
p.000001: derived therefrom, the best known of these alkaloids being morphia, heroin, and co- deine, obtained from
p.000001: opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives
p.000001: ob- tained either from the raw material or from the various alkaloids; Indian hemp and its various
p.000001: derivatives, compounds, and prepara- tions, and peyote in its various forms; isonipecaine and its deriva-
p.000001: 1
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 201 PUBLIC HEALTH SERVICE ACT 2
p.000001:
p.000001: tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code);
p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
p.000001:
p.000001:
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p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were
p.000001: all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan
p.000001: abolished the National Institutes of Health as an agency, it did not abolish the individual research
p.000001: institutes.
p.000001: In 1985, Public Law 99–158 added title IV of this Act, which provides that the National Insti- tutes of Health is an
p.000001: agency of the Public Health Service. See section 401(a).
p.000001: Other laws have established additional agencies within the Service. Section 501(a) of this Act provides that the
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p.000001: as amended.
p.000001: (3) APPOINTMENT.—Commissioned officers of the Ready Re- serve Corps shall be appointed by the President and
p.000001: commis- sioned officers of the Regular Corps shall be appointed by the President.
p.000001: (4) ACTIVE DUTY.—Commissioned officers of the Ready Re- serve Corps shall at all times be subject to call to
p.000001: active duty by the Surgeon General, including active duty for the purpose of training.
p.000001: (5) WARRANT OFFICERS.—Warrant officers may be ap- pointed to the Service for the purpose of
p.000001: providing support to the health and delivery systems maintained by the Service and any warrant officer appointed
p.000001: to the Service shall be consid- ered for purposes of this Act and title 37, United States Code, to be a
p.000001: commissioned officer within the Commissioned Corps of the Service.
p.000001: (b) ASSIMILATING RESERVE CORP OFFICERS INTO THE REGULAR CORPS.—Effective on the date of enactment of the
p.000001: Patient Protec- tion and Affordable Care Act, all individuals classified as officers in the Reserve Corps
p.000001: under this section (as such section existed on the day before the date of enactment of such Act) and serving
p.000001: on
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p.000001: January 30, 2020
p.000001: Although not established in this Act, the Centers for Disease Control and Prevention, the Health
p.000001: Resources and Services Administration, and the Agency for Toxic Substances and Dis- ease Registry are
p.000001: agencies of the Service.
p.000001: The Food and Drug Administration is also an agency of the Service.
p.000001: 2 So in law. See section 2008(g)(2) of Public Law 103–43 (107 Stat. 212). The term ‘‘the Agen- cy’’ probably should
p.000001: be preceded by ‘‘(5)’’, and the ‘‘and’’ before ‘‘(4)’’ probably should be struck. Further, Public Law
p.000001: 106–129 redesignated the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality
p.000001: (see 113 Stat. 1653).
p.000001: 3 Civil service and classification laws are now codified to title 5, United States Code.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 203A PUBLIC HEALTH SERVICE ACT 4
p.000001:
p.000001: active duty shall be deemed to be commissioned officers of the Reg- ular Corps.
p.000001: (c) PURPOSE AND USE OF READY RESEARCH.—
p.000001: (1) PURPOSE.—The purpose of the Ready Reserve Corps is to fulfill the need to have additional Commissioned
p.000001: Corps per- sonnel available on short notice (similar to the uniformed serv- ice’s reserve program) to assist
p.000001: regular Commissioned Corps personnel to meet both routine public health and emergency response missions.
p.000001: (2) USES.—The Ready Reserve Corps shall—
p.000001: (A) participate in routine training to meet the general and specific needs of the Commissioned Corps;
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p.000001: (2) designed to reduce the number of applications, reports, and other materials required under such programs to
p.000001: be sub- mitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the extent
p.000001: feasible), the data and information required to be contained in such applications, reports, and other materials; and
p.000001: (3) under which inconsistent or duplicative requirements imposed by such programs will be revised and
p.000001: made uniform with respect to such project;
p.000001: except that nothing in this section shall be construed to authorize the Secretary to waive or suspend, with
p.000001: respect to any such project, any requirement with respect to any of such programs if such re- quirement is
p.000001: imposed by law or by any regulation required by law.
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p.000001: January 30, 2020
p.000001: ORPHAN PRODUCTS BOARD
p.000001: SEC. 227. ø236¿ (a) There is established in the Department of Health and Human Services a board for the
p.000001: development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or
p.000001: conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for
p.000001: Health of the Department of Health and Human Services and rep- resentatives, selected by the Secretary, of the
p.000001: Food and Drug Ad- ministration, the National Institutes of Health, the Centers for Dis- ease Control and Prevention,
p.000001: and any other Federal department or agency which the Secretary determines has activities relating to drugs and
p.000001: devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board.
p.000001: (b) The function of the Board shall be to promote the develop- ment of drugs and devices for rare diseases or
p.000001: conditions and the coordination among Federal, other public, and private agencies in carrying out their
p.000001: respective functions relating to the development of such articles, such diseases or conditions.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 227 PUBLIC HEALTH SERVICE ACT 46
p.000001:
p.000001: (c) In the case of drugs for rare diseases or conditions the Board shall—
p.000001: (1) evaluate—
p.000001: (A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act on the development of such drugs,
p.000001: and
p.000001: (B) the implementation of such subchapter; 15
p.000001: (2) evaluate the activities of the National Institutes of Health for the development of drugs for such diseases
p.000001: or condi- tions,
p.000001: (3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health
p.000001: and the Centers for Disease Control and Prevention in the carrying out of their respective functions relating to
p.000001: the development of drugs for such diseases or conditions to assure that the activi- ties of each agency are
p.000001: complementary.
p.000001: (4) assure appropriate coordination among all interested Federal agencies, manufacturers, and
p.000001: organizations rep- resenting patients, in their activities relating to such drugs,
p.000001: (5) with the consent of the sponsor of a drug for a rare dis- ease or condition exempt under section 505(i) of
p.000001: the Federal Food, Drug, and Cosmetic Act or regulations issued under such section, inform physicians and the
p.000001: public respecting the avail- ability of such drug for such disease or condition and inform physicians and
p.000001: the public respecting the availability of drugs approved under section 505(c) of such Act or licensed
p.000001: under section 351 of this Act for rare diseases or conditions,
p.000001: (6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions,
p.000001: seek inves- tigators to facilitate the development of such drugs, and seek business entities to participate
p.000001: in the distribution of such drugs, and
p.000001: (7) recognize the efforts of public and private entities and individuals in seeking the development of
p.000001: drugs for rare dis- eases or conditions and in developing such drugs.
p.000001: (d) The Board shall consult with interested persons respecting the activities of the Board under this section
p.000001: and as part of such consultation shall provide the opportunity for the submission of oral views.
p.000001: (e) The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on
p.000001: Energy and Commerce of the House of Representatives an annual report—
p.000001: (1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and
p.000001: Cosmetic Act for a rare disease or condition,
p.000001: (2) describing the activities of the Board, and
p.000001: (3) containing the results of the evaluations carried out by the Board.
p.000001: The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual
p.000001: report a report on the rare disease and condition research activities of the Institutes of the Na- tional
p.000001: Institutes of Health; the Secretary of the Treasury shall sub-
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 15 So in law. The semicolon probably should be a comma.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 47 PUBLIC HEALTH SERVICE ACT Sec. 228
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p.000001: January 30, 2020
p.000001: mit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by
p.000001: section 44H of the Inter- nal Revenue Code of 1954; and the Secretary of Health and Human Services shall submit
p.000001: to the Board for inclusion in the annual re- port a report on the program of assistance under section
p.000001: 5 of the Orphan Drug Act for the development of drugs for rare diseases and conditions. Each annual
p.000001: report shall be submitted by June 1 of each year for the preceding calendar year.
p.000001: SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE
p.000001: SEC. 228. ø237¿ (a)(1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical
p.000001: Research and Bio- medical Product Assessment Service (in this section referred to as the ‘‘Service’’), not
p.000001: to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified
p.000001: scientific and technical experts in the fields of biomedical research, clinical re- search evaluation, and
p.000001: biomedical product assessment.
p.000001: (2) The authority established in paragraph (1) may not be con- strued to require the Secretary to reduce the number of
p.000001: employees serving under any other employment system in order to offset the number of members serving in the
p.000001: Service.
p.000001: (3) The Secretary shall assign experts under this section to agencies within the Department of Health
p.000001: and Human Services taking into account the need for the expertise of such expert.
p.000001: (b) The Service shall be appointed by the Secretary without re- gard to the provisions of title 5, United States Code,
p.000001: regarding ap- pointment, and shall consist of individuals outstanding in the field of biomedical research, clinical
p.000001: research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such
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p.000001: span;
p.000001: (2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues
p.000001: relating to women’s health;
p.000001: (3) monitor the Department of Health and Human Serv- ices’ offices, agencies, and regional activities
p.000001: regarding wom- en’s health and identify needs regarding the coordination of ac- tivities, including intramural and
p.000001: extramural multidisciplinary activities;
p.000001: (4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be
p.000001: chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from
p.000001: each of the agencies and offices of the Department of Health and Human Services;
p.000001: (5) establish a National Women’s Health Information Cen- ter to—
p.000001:
p.000001:
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p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 16 Section 3509 of the Patient Protection and Affordable Care Act (Public Law 111–148, en- acted March 23,
p.000001: 2010) established offices of womens health in the Office of the Secretary of HHS (this section), the Centers for
p.000001: Disease Control and Prevention (section 310A of this Act), the Agency for Healthcare Research and Quality
p.000001: (section 925 of this Act), the Health Resources and Services Administration (section 713 of the Social Security Act),
p.000001: and the Food and Drug Admin- istration (section 1011 of the Federal Food, Drug, and Cosmetic Act).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 49 PUBLIC HEALTH SERVICE ACT Sec. 231
p.000001:
p.000001: (A) facilitate the exchange of information regarding matters relating to health information, health
p.000001: promotion, preventive health services, research advances, and edu- cation in the appropriate use of health care;
p.000001: (B) facilitate access to such information;
p.000001: (C) assist in the analysis of issues and problems relat- ing to the matters described in this paragraph; and
p.000001: (D) provide technical assistance with respect to the ex- change of information (including facilitating the
p.000001: develop- ment of materials for such technical assistance);
p.000001: (6) coordinate efforts to promote women’s health programs and policies with the private sector; and
p.000001: (7) through publications and any other means appropriate, provide for the exchange of information between the Office
p.000001: and recipients of grants, contracts, and agreements under sub- section (c), and between the Office and
p.000001: health professionals and the general public.
p.000001: (c) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.000001: (1) AUTHORITY.—In carrying out subsection (b), the Sec- retary may make grants to, and enter into
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p.000001: Immigration and Naturaliza- tion Service unless such persons are entitled to care and treatment under section 322(a).
p.000017: 17
p.000017: MONEY COLLECTED FOR CARE OF PATIENTS
p.000017: SEC. 233. ø238b¿ Money collected as provided by law for ex- penses incurred in the care and treatment
p.000017: of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts
p.000017: received from any executive department on ac- count of care and treatment of pay patients, shall be
p.000017: covered into the appropriation from which the expenses of such care and treat- ment were paid.
p.000017: TRANSPORTATION OF REMAINS OF OFFICERS
p.000017: SEC. 234. ø238c¿ Appropriations available for traveling ex- penses of the Service shall be available for
p.000017: meeting the cost of preparation for burial and of transportation to the place of burial of remains of
p.000017: commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations
p.000017: available for carrying out the provisions of this Act shall also be available for the payment of such
p.000017: expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may
p.000017: be authorized under other provisions of law.
p.000017: GRANTS TO FEDERAL INSTITUTIONS
p.000017: SEC. 235. ø238d¿ Appropriations to the Public Health Service available under this Act for research,
p.000017: training, or demonstration project grants or for grants to expand existing treatment and re- search
p.000017: programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations
p.000017: under title VI of the Mental Health Systems Act shall also be available, on the same terms and conditions as
p.000017: apply to non-Federal institutions, for grants for the same purpose to Federal institutions, except that grants
p.000017: to such Federal institutions may be funded at 100 per cen- tum of the costs.
p.000017: TRANSFER OF FUNDS
p.000017: SEC. 236. ø238e¿ For the purpose of any reorganization under section 202, the Secretary, with the approval of the
p.000017: Director of the Bureau of the Budget, 18 is authorized to make such transfers of funds between
p.000017: appropriations as may be necessary for the continu- ance of transferred functions.
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 59 PUBLIC HEALTH SERVICE ACT Sec. 261
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p.000017: January 30, 2020
p.000017: (e) DEFINITIONS.—
p.000017: (1) PERCEIVED MEDICAL EMERGENCY.—For purposes of this section, the term ‘‘perceived medical emergency’’ means
p.000017: cir- cumstances in which the behavior of an individual leads a rea- sonable person to believe that the individual is
p.000017: experiencing a life-threatening medical condition that requires an immediate medical response regarding the heart
p.000017: or other cardiopulmonary functioning of the individual.
p.000017: (2) OTHER DEFINITIONS.—For purposes of this section:
p.000017: (A) The term ‘‘automated external defibrillator device’’ means a defibrillator device that—
p.000017: (i) is commercially distributed in accordance with the Federal Food, Drug, and Cosmetic Act;
p.000017: (ii) is capable of recognizing the presence or ab- sence of ventricular fibrillation, and is capable of
p.000017: de- termining without intervention by the user of the de- vice whether defibrillation should be performed;
p.000017: (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an
p.000017: individual; and
p.000017: (iv) in the case of a defibrillator device that may be operated in either an automated or a manual mode, is
p.000017: set to operate in the automated mode.
p.000017: (B)(i) The term ‘‘harm’’ includes physical, nonphysical, economic, and noneconomic losses.
p.000017: (ii) The term ‘‘economic loss’’ means any pecuniary loss resulting from harm (including the loss of earnings or
p.000017: other benefits related to employment, medical expense loss, replacement services loss, loss due to
p.000017: death, burial costs, and loss of business or employment opportunities) to the extent recovery for such loss is allowed
p.000017: under applica- ble State law.
p.000017: (iii) The term ‘‘noneconomic losses’’ means losses for physical and emotional pain, suffering,
p.000017: inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and
p.000017: companionship, loss of consortium (other than loss of domestic service), hedonic damages, injury to reputation and
p.000017: all other nonpecuniary losses of any kind or nature.
p.000017: PART C—SMALLPOX EMERGENCY PERSONNEL PROTECTION
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p.000017: (g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of
p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
p.000017:
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p.000017: January 30, 2020
p.000017: NARCOTICS
p.000017: SEC. 302. ø242¿ (a) In carrying out the purposes of section 301 with respect to drugs the use or misuse of
p.000017: which might result in drug abuse or dependency, the studies and investigations author- ized therein shall
p.000017: include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further
p.000017: include the quantities of crude opium, coca leaves, and their salts, deriva- tives, and preparations, and
p.000017: other drugs subject to control under the Controlled Substances Act and Controlled Substances Import and
p.000017: Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific
p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 304 PUBLIC HEALTH SERVICE ACT 78
p.000017:
p.000017: experience in the care, treatment, and rehabilitation of narcotic ad- dicts to the end that each State may be
p.000017: encouraged to provide ade- quate facilities and methods for the care and treatment of its nar- cotic addicts.
p.000017: GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND DEMONSTRATIONS IN HEALTH STATISTICS, HEALTH
p.000017: SERVICES, AND HEALTH CARE TECHNOLOGY ASSESSMENT
p.000017: SEC. 304. 1 ø242b¿ (a) The Secretary may, through the Agency for Health Care Policy and Research or the
p.000017: National Center for Health Statistics or using National Research Service Awards or other appropriate
p.000017: authorities, undertake and support training pro- grams to provide for an expanded and continuing supply of individ-
p.000017: uals qualified to perform the research, evaluation, and demonstra- tion projects set forth in section 306 and in title
p.000017: IX.
p.000017: (b) To implement subsection (a) and section 306, the Secretary may, in addition to any other authority which
p.000017: under other provi- sions of this Act or any other law may be used by him to imple- ment such
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p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
p.000017:
p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
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p.000017: (a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal
p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
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p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
...

p.000117: including
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000117: Sec. 317E PUBLIC HEALTH SERVICE ACT 118
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p.000117: January 30, 2020
p.000117:
p.000117: drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and
p.000117: non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis,
p.000117: including multidrug resistant tu- berculosis. The Secretary is encouraged to give priority to pro- grammatically
p.000117: relevant research so that new tools can be uti- lized in public health practice.
p.000117: (3) Demonstration projects for—
p.000117: (A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent
p.000117: multidrug resistant and extensively drug resistant strains of tuber- culosis;
p.000117: (B) the intensification of efforts to reduce health dis- parities in the incidence of tuberculosis;
p.000117: (C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among
p.000117: United States-Mexico binational populations, including through expansion of the scope and number of programs
p.000117: that—
p.000117: (i) detect and treat binational cases of tuber- culosis; and
p.000117: (ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
p.000117: (D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are
p.000117: in the United States;
p.000117: (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings
p.000117: docu- mented as having a high risk for tuberculosis; and
p.000117: (F) tuberculosis detection, control, and prevention.
p.000117: (4) Public information and education activities.
p.000117: (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention
p.000117: for health profes- sionals, including allied health personnel and emergency re- sponse employees.
p.000117: (6) Support of Centers to carry out activities under para- graphs (1) through (4).
p.000117: (7) Collaboration with international organizations and for- eign countries in carrying out such activities.
...

p.000121: country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and
p.000121: disciplines relevant to the research under consideration.
p.000121: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000121:
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p.000121: Sec. 317F PUBLIC HEALTH SERVICE ACT 122
p.000121:
p.000121: (1) GENERAL PROGRAM.—
p.000121: (A) IN GENERAL.—For the purpose of carrying out this section, there are authorized to be appropriated
p.000121: $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011,
p.000121: $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013.
p.000121: (B) RESERVATION FOR EMERGENCY GRANTS.—Of the amounts appropriated under subparagraph (A) for a fiscal year,
p.000121: the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geo-
p.000121: graphic area, State, political subdivision of a State, or other public entity in which there is,
p.000121: relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant
p.000121: tuberculosis, or extensively drug re- sistant tuberculosis or a substantial rate of increase in such cases.
p.000121: (C) PRIORITY.—In allocating amounts appropriated under subparagraph (A), the Secretary shall give
p.000121: priority to allocating such amounts for grants under subsection (a).
p.000121: (D) ALLOCATION OF FUNDS.—
p.000121: (i) REQUIREMENT OF FORMULA.—Of the amounts appropriated under subparagraph (A), not reserved under
p.000121: subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall
p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
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p.000121: January 30, 2020
p.000121: LOAN REPAYMENT PROGRAM
p.000121: SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
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p.000133: multi-dimensional delivery system for oral health, and to implement science-based programs (including
p.000133: dental sealants and community water fluoridation) to improve oral health.
p.000133: (2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
p.000133: ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through
p.000133: 2014.
p.000133: (e) DEFINITIONS.—For purposes of this section, the term ‘‘In- dian tribe’’ means an Indian tribe or tribal
p.000133: organization as defined in section 4(b) and section 4(c) of the Indian Self-Determination and Education
p.000133: Assistance Act.
p.000133: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000133: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: PUBLIC HEALTH SERVICE ACT
p.000135: Sec. 317O
p.000135:
p.000135: SEC. 317N. ø247b–15¿ SURVEILLANCE AND EDUCATION REGARDING IN- FECTIONS ASSOCIATED WITH ILLICIT DRUG USE AND
p.000135: OTHER RISK FACTORS.
p.000135: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000135: may (directly or through grants to public and nonprofit private entities) provide for programs for the following:
p.000135: (1) To cooperate with States and Indian tribes in imple- menting or maintaining a national system to determine
p.000135: the in- cidence of infections commonly associated with illicit drug use, such as viral hepatitis, human
p.000135: immunodeficiency virus, and in- fective endocarditis, and to assist the States in determining the prevalence of such
p.000135: infections, which may include the reporting of cases of such infections.
p.000135: (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph
p.000135: (1) result- ing from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
p.000135: (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified
p.000135: under para- graph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
p.000135: (4) To develop and disseminate public information and education programs for the detection and control of
p.000135: infections described in paragraph (1), with priority given to high-risk populations as determined by the
p.000135: Secretary.
p.000135: (5) To improve the education, training, and skills of health professionals in the detection and control of
p.000135: infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use
p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
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p.000137: Sec. 317P PUBLIC HEALTH SERVICE ACT 138
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p.000137: January 30, 2020
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p.000137: (C) the available scientific evidence on the effective- ness or lack of effectiveness of condoms in
p.000137: preventing in- fection with HPV; and
p.000137: (D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of
p.000137: cer- vical cancer purposes in preventing cervical cancer.
p.000137: (2) MEDICALLY ACCURATE INFORMATION.—Educational ma- terial under paragraph (1), and all other relevant
p.000137: educational and prevention materials prepared and printed from this date forward for the public and health
p.000137: care providers by the Sec- retary (including materials prepared through the Food and Drug Administration,
p.000137: the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or
p.000137: by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV
p.000137: shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in
p.000137: preventing the STD the materials are designed to address. Such requirement only applies to materials mass
p.000137: produced for the public and health care providers, and not to routine communications.
p.000137: (d) JOHANNA’S LAW.—
p.000137: (1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
p.000137: (A) IN GENERAL.—The Secretary shall carry out a na- tional campaign to increase the awareness and knowledge of
p.000137: health care providers and women with respect to gynecologic cancers.
p.000137: (B) WRITTEN MATERIALS.—Activities under the na- tional campaign under subparagraph (A) shall include—
p.000137: (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers;
p.000137: and
p.000137: (ii) distributing the materials to members of the public upon request.
p.000137: (C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities under the national campaign under subparagraph
p.000137: (A) shall, in accordance with applicable law and regulations, include developing and placing, in
p.000137: telecommunications media, public service announcements intended to encour- age women to discuss with their
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p.000139: years.
p.000139: (II) The background and history of such activ- ity, including—
p.000139: (aa) the goals of such activity;
p.000139: (bb) the communications objectives of such activity;
p.000139: (cc) the identity of each agency within the Department of Health and Human Services responsible for any aspect of
p.000139: the activity; and (dd) how such activity is or was expected
p.000139: to result in change.
p.000139: (III) How long the activity lasted or is ex- pected to last.
p.000139: (IV) The outcomes observed and the evalua- tion methods, if any, that have been, are being, or will be used with
p.000139: respect to such activity.
p.000139: (V) For each such outcome or evaluation method, a description of the associated results, analyses,
p.000139: and conclusions.
p.000139: (B) STRATEGY.—
p.000139: (i) DEVELOPMENT; SUBMISSION TO CONGRESS.—Not later than 3 months after submitting the report re- quired by
p.000139: subparagraph (A), the Secretary shall de- velop and submit to the Congress a strategy for im- proving
p.000139: efforts to increase awareness and knowledge of the public and health care providers with respect to different
p.000139: types of cancer, including gynecological can- cers.
p.000139: (ii) CONSULTATION.—In developing the strategy under clause (i), the Secretary should consult with
p.000139: qualified private sector groups, including nonprofit or- ganizations.
p.000139: (3) FULL COMPLIANCE.—
p.000139: (A) IN GENERAL.—Not later than March 1, 2008, the Secretary shall ensure that all provisions of this
p.000139: section, including activities directed to be carried out by the Cen- ters for Disease Control and Prevention
p.000139: and the Food and Drug Administration, are fully implemented and being complied with. Not later than April 30,
p.000139: 2008, the Secretary shall submit to Congress a report that certifies compliance with the preceding sentence and
p.000139: that contains a descrip- tion of all activities undertaken to achieve such compli- ance.
p.000139: (B) If the Secretary fails to submit the certification as provided for under subparagraph (A), the Secretary
p.000139: shall,
p.000139: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000139: Sec. 317Q PUBLIC HEALTH SERVICE ACT 140
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p.000139: not later than 3 months after the date on which the report is to be submitted under subparagraph (A), and every
p.000139: 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied
p.000139: with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the
p.000139: month for which the report is being submitted to bring the Secretary into compliance with such sentence, and
p.000139: the anticipated date the Secretary expects to be in full compliance with such sentence.
p.000139: (4) CONSULTATION WITH NONPROFIT GYNECOLOGIC CANCER ORGANIZATIONS.—In carrying out the national campaign under this
p.000139: subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a
p.000139: mission both to con- quer ovarian or other gynecologic cancer and to provide out- reach to State and local
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p.000187: fections can be shared rapidly among relevant national, State, and local health agencies and health care
p.000187: providers; and
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p.000187: January 30, 2020
p.000187: (C) develop and implement policies to control the spread of antimicrobial resistance.
p.000187: (e) GRANTS FOR DEMONSTRATION PROGRAMS.—
p.000187: (1) IN GENERAL.—The Secretary shall award competitive grants to eligible entities to establish demonstration
p.000187: programs
p.000187: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000189: PUBLIC HEALTH SERVICE ACT
p.000189: Sec. 319E
p.000189:
p.000189: to promote judicious use of antimicrobial drugs or control the spread of antimicrobial-resistant pathogens.
p.000189: (2) ELIGIBLE ENTITIES.—Eligible entities for grants under paragraph (1) may include hospitals, clinics,
p.000189: institutions of long-term care, professional medical societies, schools or pro- grams that train medical
p.000189: laboratory personnel, or other public or private nonprofit entities.
p.000189: (3) TECHNICAL ASSISTANCE.—The Secretary shall provide appropriate technical assistance to eligible entities that
p.000189: receive grants under paragraph (1).
p.000189: (f) MONITORING AT FEDERAL HEALTH CARE FACILITIES.—The Secretary shall encourage reporting on
p.000189: aggregate antimicrobial drug use and antimicrobial resistance to antimicrobial drugs and the implementation
p.000189: of antimicrobial stewardship programs by health care facilities of the Department of Defense, the Department
p.000189: of Veterans Affairs, and the Indian Health Service and shall pro- vide technical assistance to the
p.000189: Secretary of Defense and the Sec- retary of Veterans Affairs, as appropriate and upon request.
p.000189: (g) REPORT ON ANTIMICROBIAL RESISTANCE IN HUMANS AND USE OF ANTIMICROBIAL DRUGS.—Not later than 1
p.000189: year after the date of enactment of the 21st Century Cures Act, and annually thereafter, the Secretary
p.000189: shall prepare and make publicly available data and information concerning—
p.000189: (1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs,
p.000189: including such drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act;
p.000189: (2) antimicrobial stewardship, which may include sum- maries of State efforts to address antimicrobial
p.000189: resistance in humans to antimicrobial drugs and antimicrobial stewardship; and
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p.000189: (3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of
p.000189: Food and Drugs with respect to the monitoring of—
p.000189: (A) any applicable resistance under paragraph (1); and
p.000189: (B) drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act.
p.000189: (h) INFORMATION RELATED TO ANTIMICROBIAL STEWARDSHIP PROGRAMS.—The Secretary shall, as appropriate,
p.000189: disseminate guid- ance, educational materials, or other appropriate materials related to the development and
p.000189: implementation of evidence-based anti- microbial stewardship programs or practices at health care facili-
p.000189: ties, such as nursing homes and other long-term care facilities, am- bulatory surgical centers, dialysis centers,
p.000189: outpatient clinics, and hospitals, including community and rural hospitals.
p.000189: (i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTI- MICROBIAL RESISTANCE.—The Secretary shall
p.000189: continue to work with State and local public health departments on statewide or regional programs related to
p.000189: antimicrobial resistance. Such efforts may in- clude activities to related to—
p.000189: (1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;
p.000189: (2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and
p.000189: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000189: Sec. 319F PUBLIC HEALTH SERVICE ACT 190
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p.000189: January 30, 2020
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p.000189: (3) promoting antimicrobial stewardship.
p.000189: (j) ANTIMICROBIAL RESISTANCE AND STEWARDSHIP ACTIVITIES.—
p.000189: (1) IN GENERAL.—For the purposes of supporting steward- ship activities, examining changes in antimicrobial
p.000189: resistance, and evaluating the effectiveness of section 506(h) of the Fed- eral Food, Drug, and Cosmetic Act,
p.000189: the Secretary shall—
p.000189: (A) provide a mechanism for facilities to report data related to their antimicrobial stewardship
p.000189: activities (in- cluding analyzing the outcomes of such activities); and
p.000189: (B) evaluate—
p.000189: (i) antimicrobial resistance data using a standard- ized approach; and
p.000189: (ii) trends in the utilization of drugs approved under such section 506(h) with respect to patient pop-
p.000189: ulations.
p.000189: (2) USE OF SYSTEMS.—The Secretary shall use available systems, including the National Healthcare Safety Network
p.000189: or other systems identified by the Secretary, to fulfill the require- ments or conduct activities under this section.
p.000189: (k) ANTIMICROBIAL.—For purposes of subsections (f) through (j), the term ‘‘antimicrobial’’ includes any
p.000189: antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other
p.000189: microorganisms, as appropriate.
p.000189: (l) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this section shall be used to supplement and not
p.000189: supplant other Federal, State, and local public funds provided for activities under this section.
p.000189: (m) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000189: $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may
p.000189: be necessary for each of the fiscal years 2004 through 2006.
p.000189: SEC. 319F. ø247d–6¿ PUBLIC HEALTH COUNTERMEASURES TO A BIO- TERRORIST ATTACK.
p.000189: (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE CURRICULA AND TRAINING.—
p.000189: (1) IN GENERAL.—The Secretary, in collaboration with the Secretary of Defense, and in consultation with
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p.000193: (A) the epidemiology and pathogenesis of such patho- gens;
p.000193: (B) the sequencing of the genomes, or other DNA anal- ysis, or other comparative analysis, of priority pathogens
p.000193: (as determined by the Director of the National Institutes of Health in consultation with the working
p.000193: group estab- lished in subsection (a)), in collaboration and coordination with the activities of the
p.000193: Department of Defense and the Joint Genome Institute of the Department of Energy;
p.000193: (C) the development of priority countermeasures; and
p.000193: (D) other relevant areas of research;
p.000193: with consideration given to the needs of children and other vul- nerable populations.
p.000193: (2) PRIORITY.—The Secretary shall give priority under this section to the funding of research and other studies related
p.000193: to priority countermeasures.
p.000193: (3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In car- rying out paragraph (1), the Secretary shall consider using
p.000193: the biomedical research and development capabilities of the De- partment of Veterans Affairs, in conjunction
p.000193: with that Depart- ment’s affiliations with health-professions universities. When advantageous to the Government
p.000193: in furtherance of the pur- poses of such paragraph, the Secretary may enter into coopera- tive agreements with
p.000193: the Secretary of Veterans Affairs to achieve such purposes.
p.000193: (4) PRIORITY COUNTERMEASURES.—For purposes of this sec- tion, the term ‘‘priority countermeasure’’ means a drug,
p.000193: biologi- cal product, device, vaccine, vaccine adjuvant, antiviral, or di- agnostic test that the Secretary
p.000193: determines to be—
p.000193: (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to
p.000193: section 351A(a)(1), or harm from any other agent that may cause a public health emergency; or
p.000193: (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences
p.000193: or death
p.000193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000195: PUBLIC HEALTH SERVICE ACT
p.000195: Sec. 319F–1
p.000195:
p.000195: and may be caused by the administering of a drug, biologi- cal product, device, vaccine, vaccine adjuvant, antiviral,
p.000195: or diagnostic test that is a priority under subparagraph (A).
p.000195: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000195: (1) FISCAL YEAR 2007.—There are authorized to be appro- priated to carry out this section for fiscal year 2007—
p.000195: (A) to carry out subsection (a)—
p.000195: (i) $5,000,000 to carry out paragraphs (1) through (4); and
p.000195: (ii) $7,000,000 to carry out paragraph (5);
p.000195: (B) to carry out subsection (c), $3,000,000; and
p.000195: (C) to carry out subsection (d), $31,000,000, of which
p.000195: $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection.
p.000195: (2) SUBSEQUENT FISCAL YEARS.—There are authorized to be appropriated such sums as may be necessary to carry out this
p.000195: section for fiscal year 2008 and each subsequent fiscal year.
p.000195: SEC. 319F–1. ø247d–6a¿ AUTHORITY FOR USE OF CERTAIN PROCE- DURES REGARDING QUALIFIED COUNTERMEASURE
p.000195: RE- SEARCH AND DEVELOPMENT ACTIVITIES. 21
p.000195: (a) IN GENERAL.—
p.000195: (1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures
p.000195: under section 319F(e), the Secretary may conduct and support such activities in accordance with this
p.000195: section and, in consultation with the Director of the National Institutes of Health, as part of the program under
p.000195: section 446, if the activities concern qualified countermeasures.
p.000195: (2) DEFINITIONS.—In this section:
p.000195: (A) QUALIFIED COUNTERMEASURE.—The term ‘‘quali- fied countermeasure’’ means a drug (as that term is de-
p.000195: fined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological
p.000195: product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is
p.000195: defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the
p.000195: Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Home- land
p.000195: Security Act of 2002)—
p.000195: (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that
p.000195: cause an infectious disease) or toxin, chemical, radio- logical, or nuclear agent that may cause a
p.000195: public health emergency affecting national security;
p.000195: (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health
p.000195: consequences or death and may be caused by admin- istering a drug, biological product, or device that
p.000195: is used as described in this subparagraph; or
p.000195:
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p.000195:
p.000195: January 30, 2020
p.000195: 21 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–1 and related
p.000195: provisions of law. Section 5 is included in the appendix to this compilation.
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000195: (iii) is a product or technology intended to en- hance the use or effect of a drug, biological product, or
p.000195: device described in clause (i) or (ii).
p.000195: (B) INFECTIOUS DISEASE.—The term ‘‘infectious dis- ease’’ means a disease potentially caused by a
p.000195: pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and
p.000195: that reproduces in that person.
p.000195: (3) INTERAGENCY COOPERATION.—
p.000195: (A) IN GENERAL.—In carrying out activities under this section, the Secretary is authorized, subject to subpara-
p.000195: graph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of
p.000195: the United States Government.
p.000195: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000195: the authorities provided by this section.
p.000195: (4) AVAILABILITY OF FACILITIES TO THE SECRETARY.—In any grant, contract, or cooperative agreement entered
p.000195: into under the authority provided in this section with respect to a bio- containment laboratory or other
p.000195: related or ancillary specialized research facility that the Secretary determines necessary for the purpose of
p.000195: performing, administering, or supporting quali- fied countermeasure research and development, the Secretary
p.000195: may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be
p.000195: available as needed to the Secretary to respond to public health emergencies affect- ing national security.
p.000195: (5) TRANSFERS OF QUALIFIED COUNTERMEASURES.—Each agreement for an award of a grant, contract, or
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p.000205: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 206
p.000205:
p.000205: (1) IN GENERAL.—The Secretary shall award contracts, enter into cooperative agreements, or carry out
p.000205: such other ac- tivities as may reasonably be required in order to ensure that the stockpile under
p.000205: subsection (a) includes an amount of vac- cine against smallpox as determined by such Secretary to be
p.000205: sufficient to meet the health security needs of the United States.
p.000205: (2) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to limit the private distribution, purchase,
p.000205: or sale of vaccines from sources other than the stockpile described in subsection (a).
p.000205: (c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CER- TAIN COUNTERMEASURES; AVAILABILITY OF
p.000205: SPECIAL RESERVE FUND.—
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p.000205: (1) IN GENERAL.—
p.000205: (A) USE OF FUND.—A security countermeasure may, in accordance with this subsection, be procured with amounts in the
p.000205: special reserve fund as defined in subsection (h).
p.000205: (B) SECURITY COUNTERMEASURE.—For purposes of this subsection, the term ‘‘security countermeasure’’ means a drug
p.000205: (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42
p.000205: U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(h))) that—
p.000205: (i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of
p.000205: the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical,
p.000205: radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, miti-
p.000205: gate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may
p.000205: be caused by administering a drug, biological product, or device against such an agent;
p.000205: (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and
p.000205: (III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under
p.000205: section 351 of this Act; or
p.000205: (bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical ex-
p.000205: perience or research data (including data, if available, from pre-clinical and clinical trials) support a
p.000205: reason- able conclusion that the countermeasure will qualify for approval or licensing within 10 years after the
p.000205: date of a determination under paragraph (5); or
p.000205: (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.
p.000205: (2) DETERMINATION OF MATERIAL THREATS.—
p.000205: (A) MATERIAL THREAT.—The Homeland Security Sec- retary, in consultation with the Secretary and the heads of other
p.000205: agencies as appropriate, shall on an ongoing basis—
p.000205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000207: PUBLIC HEALTH SERVICE ACT
p.000207: Sec. 319F–2
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p.000207: (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and
p.000207: (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to
p.000207: affect national security.
p.000207: (B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER- MEASURES.—The Secretary shall on an ongoing basis—
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p.000219: declaration under paragraph (1) with respect to a covered countermeasure, the Secretary shall consider the desirability
p.000219: of encouraging the design, development, clinical testing or investigation, manufac- ture, labeling, distribution,
p.000219: formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration,
p.000219: licensing, and use of such countermeasure.
p.000219: (7) JUDICIAL REVIEW.—No court of the United States, or of any State, shall have subject matter jurisdiction to
p.000219: review, whether by mandamus or otherwise, any action by the Sec- retary under this subsection.
p.000219: (8) PREEMPTION OF STATE LAW.—During the effective pe- riod of a declaration under subsection (b), or at any
p.000219: time with respect to conduct undertaken in accordance with such declara- tion, no State or political subdivision of a
p.000219: State may establish, enforce, or continue in effect with respect to a covered counter- measure any provision of law or
p.000219: legal requirement that—
p.000219: (A) is different from, or is in conflict with, any require- ment applicable under this section; and
p.000219: (B) relates to the design, development, clinical testing or investigation, formulation, manufacture,
p.000219: distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other
p.000219: aspect of safety or effi- cacy, or the prescribing, dispensing, or administration by qualified persons of
p.000219: the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under
p.000219: this section or any other provision of this Act, or under the Federal Food, Drug, and Cosmetic Act.
p.000219: (9) REPORT TO CONGRESS.—Within 30 days after making a declaration under paragraph (1), the Secretary shall submit to
p.000219: the appropriate committees of the Congress a report that pro- vides an explanation of the reasons for issuing
p.000219: the declaration and the reasons underlying the determinations of the Sec- retary with respect to paragraph
p.000219: (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such
p.000219: committees a report that provides the rea- sons underlying the determination of the Secretary to make the
p.000219: amendment.
p.000219: (c) DEFINITION OF WILLFUL MISCONDUCT.—
p.000219: (1) DEFINITION.—
p.000219: (A) IN GENERAL.—Except as the meaning of such term is further restricted pursuant to paragraph (2), the term
p.000219: ‘‘willful misconduct’’ shall, for purposes of subsection (d), denote an act or omission that is taken—
p.000219: (i) intentionally to achieve a wrongful purpose;
p.000219: (ii) knowingly without legal or factual justifica- tion; and
p.000219: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000221: PUBLIC HEALTH SERVICE ACT
p.000221: Sec. 319F–3
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p.000221: initial rulemaking process under this paragraph.
p.000221: (3) PROOF OF WILLFUL MISCONDUCT.—In an action under subsection (d), the plaintiff shall have the burden of
p.000221: proving by clear and convincing evidence willful misconduct by each cov- ered person sued and that such
p.000221: willful misconduct caused death or serious physical injury.
p.000221: (4) DEFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO SECRETARY’S DECLARATION.—Notwithstanding any other
p.000221: provi- sion of law, a program planner or qualified person shall not have engaged in ‘‘willful misconduct’’ as
p.000221: a matter of law where such program planner or qualified person acted consistent with applicable directions,
p.000221: guidelines, or recommendations by the Secretary regarding the administration or use of a covered
p.000221: countermeasure that is specified in the declaration under sub- section (b), provided either the Secretary, or a
p.000221: State or local health authority, was provided with notice of information re- garding serious physical
p.000221: injury or death from the administra- tion or use of a covered countermeasure that is material to the plaintiff’s
p.000221: alleged loss within 7 days of the actual discovery of such information by such program planner or qualified
p.000221: person.
p.000221: (5) EXCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER OR DISTRIBUTOR.—
p.000221: (A) IN GENERAL.—If an act or omission by a manufac- turer or distributor with respect to a covered counter-
p.000221: measure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to
p.000221: regu- lation by this Act or by the Federal Food, Drug, and Cos-
p.000221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000221: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 222
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p.000221: metic Act, such act or omission shall not constitute ‘‘willful misconduct’’ for purposes of subsection (d) if—
p.000221: (i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act
p.000221: or omission; or
p.000221: (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a
p.000221: covered remedy.
p.000221: Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement
p.000221: action.
p.000221: (B) DEFINITIONS.—For purposes of this paragraph, the following terms have the following meanings:
p.000221: (i) ENFORCEMENT ACTION.—The term ‘‘enforcement action’’ means a criminal prosecution, an action seek- ing an
p.000221: injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall
p.000221: of a product because voluntary recall was re- fused, a proceeding to compel repair or replacement of a product,
p.000221: a termination of an exemption under sec- tion 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic
p.000221: Act, a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or
p.000221: agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of
p.000221: such Act, or a suspension or withdrawal, based on willful misconduct, of an approval or clear- ance under
p.000221: chapter V of such Act or of a licensure under section 351 of this Act.
p.000221: (ii) COVERED REMEDY.—The term ‘‘covered rem- edy’’ means an outcome—
p.000221: (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product
p.000221: recall, a repair or replacement of a prod- uct, a termination of an exemption under section 505(i) or
p.000221: 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment, an investigator dis- qualification, a
p.000221: revocation of an authorization under section 564 of such Act, or a suspension or withdrawal of an
p.000221: approval or clearance under chapter 5 of such Act or of a licensure under sec- tion 351 of this Act;
p.000221: and
p.000221: (II) that results from a final determination by a court or from a final agency action.
p.000221: (iii) FINAL.—The terms ‘‘final’’ and ‘‘finally’’—
p.000221: (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court
p.000221: determination, mean a judgment from which an appeal of right cannot be taken or a vol- untary or stipulated
p.000221: dismissal; and
p.000221: (II) with respect to an agency action, or to a final resolution of an enforcement action that is an
p.000221: agency action, mean an order that is not sub- ject to further review within the agency and that has not
p.000221: been reversed, vacated, enjoined, or other-
p.000221: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000221:
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p.000223: PUBLIC HEALTH SERVICE ACT
p.000223: Sec. 319F–3
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p.000223: January 30, 2020
p.000223: wise nullified by a final court determination or a voluntary or stipulated dismissal.
p.000223: (C) RULES OF CONSTRUCTION.—
p.000223: (i) IN GENERAL.—Nothing in this paragraph shall be construed—
p.000223: (I) to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act, of this Act, or
p.000223: of any other applicable statute or reg- ulation; or
p.000223: (II) to impair, delay, alter, or affect the au- thority, including the enforcement discretion, of the
p.000223: United States, of the Secretary, of the Attor- ney General, or of any other official with respect to
p.000223: any administrative or court proceeding under this Act, under the Federal Food, Drug, and Cos- metic Act,
p.000223: under title 18 of the United States Code, or under any other applicable statute or regulation.
p.000223: (ii) MANDATORY RECALLS.—A mandatory recall called for in the declaration is not a Food and Drug
p.000223: Administration enforcement action.
p.000223: (d) EXCEPTION TO IMMUNITY OF COVERED PERSONS.—
p.000223: (1) IN GENERAL.—Subject to subsection (f), the sole excep- tion to the immunity from suit and liability of
p.000223: covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a
p.000223: covered person for death or serious physical injury proximately caused by willful misconduct, as defined
p.000223: pursuant to subsection (c), by such covered person. For purposes of section 2679(b)(2)(B) of title 28, United
p.000223: States Code, such a cause of action is not an action brought for viola- tion of a statute of the United States
p.000223: under which an action against an individual is otherwise authorized.
p.000223: (2) PERSONS WHO CAN SUE.—An action under this sub- section may be brought for wrongful death or serious
p.000223: physical injury by any person who suffers such injury or by any rep- resentative of such a person.
p.000223: (e) PROCEDURES FOR SUIT.—
p.000223: (1) EXCLUSIVE FEDERAL JURISDICTION.—Any action under subsection (d) shall be filed and maintained only in the
p.000223: United States District Court for the District of Columbia.
p.000223: (2) GOVERNING LAW.—The substantive law for decision in an action under subsection (d) shall be derived
p.000223: from the law, including choice of law principles, of the State in which the al- leged willful misconduct occurred,
p.000223: unless such law is incon- sistent with or preempted by Federal law, including provisions of this section.
p.000223: (3) PLEADING WITH PARTICULARITY.—In an action under subsection (d), the complaint shall plead with
p.000223: particularity each element of the plaintiff’s claim, including—
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p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
p.000225: section, or any amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed
p.000225: to affect the National Vaccine In- jury Compensation Program under title XXI of this Act.
p.000225: (i) DEFINITIONS.—In this section:
p.000225: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means—
p.000225: (A) a qualified pandemic or epidemic product (as de- fined in paragraph (7));
p.000225: (B) a security countermeasure (as defined in section 319F–2(c)(1)(B)); or
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000227: 227
p.000227: PUBLIC HEALTH SERVICE ACT
p.000227: Sec. 319F–3
p.000227:
p.000227: (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21
p.000227: U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or device
p.000227: (as such term is de- fined by section 201(h) of the Federal Food, Drug and Cos- metic Act (21 U.S.C. 321(h))
p.000227: that is authorized for emer- gency use in accordance with section 564, 564A, or 564B of the Federal Food,
p.000227: Drug, and Cosmetic Act.
p.000227: (2) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration or use of
p.000227: a covered countermeasure, means—
p.000227: (A) the United States; or
p.000227: (B) a person or entity that is—
p.000227: (i) a manufacturer of such countermeasure;
p.000227: (ii) a distributor of such countermeasure;
p.000227: (iii) a program planner of such countermeasure;
p.000227: (iv) a qualified person who prescribed, adminis- tered, or dispensed such countermeasure; or
p.000227: (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
p.000227: (3) DISTRIBUTOR.—The term ‘‘distributor’’ means a person or entity engaged in the distribution of drugs,
p.000227: biologics, or de- vices, including but not limited to manufacturers; repackers; common carriers; contract
p.000227: carriers; air carriers; own-label dis- tributors; private-label distributors; jobbers; brokers; ware-
p.000227: houses, and wholesale drug warehouses; independent whole- sale drug traders; and retail pharmacies.
p.000227: (4) MANUFACTURER.—The term ‘‘manufacturer’’ includes—
p.000227: (A) a contractor or subcontractor of a manufacturer;
p.000227: (B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other
p.000227: arti- cle used in the design, development, clinical testing, inves- tigation, or manufacturing of a covered
p.000227: countermeasure; and
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p.000227: January 30, 2020
p.000227: (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
p.000227: (5) PERSON.—The term ‘‘person’’ includes an individual, partnership, corporation, association, entity, or
p.000227: public or pri- vate corporation, including a Federal, State, or local govern- ment agency or department.
p.000227: (6) PROGRAM PLANNER.—The term ‘‘program planner’’ means a State or local government, including an
p.000227: Indian tribe, a person employed by the State or local government, or other person who supervised or
p.000227: administered a program with respect to the administration, dispensing, distribution, provision, or use of a
p.000227: security countermeasure or a qualified pandemic or epidemic product, including a person who has
p.000227: established re- quirements, provided policy guidance, or supplied technical or scientific advice or
p.000227: assistance or provides a facility to admin- ister or use a covered countermeasure in accordance with a
p.000227: declaration under subsection (b).
p.000227: (7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘‘qualified pandemic or epidemic product’’ means a drug
p.000227: (as such term is defined in section 201(g)(1) of the Federal Food,
p.000227: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000227: Sec. 319F–4 PUBLIC HEALTH SERVICE ACT 228
p.000227:
p.000227: Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological prod- uct (as such term is defined by section
p.000227: 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic
p.000227: Act (21 U.S.C. 321(h)) that is—
p.000227: (A)(i) a product manufactured, used, designed, devel- oped, modified, licensed, or procured—
p.000227: (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
p.000227: (II) to limit the harm such pandemic or epidemic might otherwise cause;
p.000227: (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate,
p.000227: pre- vent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause
p.000227: (i); or
p.000227: (iii) 23 a product or technology intended to enhance the use or effect of a drug, biological product, or device
p.000227: described in clause (i) or (ii); and
p.000227: (B)(i) approved or cleared under chapter V of the Fed- eral Food, Drug, and Cosmetic Act or licensed under
p.000227: sec- tion 351 of this Act;
p.000227: (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an
p.000227: exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; or
p.000227: (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and
p.000227: Cosmetic Act.
p.000227: (8) QUALIFIED PERSON.—The term ‘‘qualified person’’, when used with respect to the administration or use of a
p.000227: covered countermeasure, means—
p.000227: (A) a licensed health professional or other individual who is authorized to prescribe, administer, or
p.000227: dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered,
p.000227: or dis- pensed; or
p.000227: (B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
p.000227: (9) SECURITY COUNTERMEASURE.—The term ‘‘security coun- termeasure’’ has the meaning given such term in section 319F–
p.000227: 2(c)(1)(B).
p.000227: (10) SERIOUS PHYSICAL INJURY.—The term ‘‘serious phys- ical injury’’ means an injury that—
p.000227: (A) is life threatening;
p.000227: (B) results in permanent impairment of a body func- tion or permanent damage to a body structure; or
p.000227: (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or per-
p.000227: manent damage to a body structure.
p.000227: SEC. 319F–4. ø247d–6e¿ COVERED COUNTERMEASURE PROCESS.
p.000227: (a) ESTABLISHMENT OF FUND.—Upon the issuance by the Sec- retary of a declaration under section 319F–3(b), there
p.000227: is hereby es- tablished in the Treasury an emergency fund designated as the
p.000227:
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p.000227: January 30, 2020
p.000227: 23 Margin of clause (iii) so in law.
p.000227:
p.000227: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000235: PUBLIC HEALTH SERVICE ACT
p.000235: Sec. 319L
p.000235:
p.000235: SEC. 319L. ø247d–7e¿ BIOMEDICAL ADVANCED RESEARCH AND DEVEL- OPMENT AUTHORITY.
p.000235: (a) DEFINITIONS.—In this section:
p.000235: (1) BARDA.—The term ‘‘BARDA’’ means the Biomedical Advanced Research and Development Authority.
p.000235: (2) FUND.—The term ‘‘Fund’’ means the Biodefense Med- ical Countermeasure Development Fund established
p.000235: under subsection (d).
p.000235: (3) OTHER TRANSACTIONS.—The term ‘‘other transactions’’ means transactions, other than procurement contracts,
p.000235: grants, and cooperative agreements.
p.000235: (4) QUALIFIED COUNTERMEASURE.—The term ‘‘qualified countermeasure’’ has the meaning given such term in
p.000235: section 319F–1.
p.000235: (5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘‘qualified pandemic or epidemic product’’ has the
p.000235: meaning given the term in section 319F–3.
p.000235: (6) ADVANCED RESEARCH AND DEVELOPMENT.—
p.000235: (A) IN GENERAL.—The term ‘‘advanced research and development’’ means, with respect to a product that is
p.000235: or may become a qualified countermeasure or a qualified pan- demic or epidemic product, activities that predominantly—
p.000235: (i) are conducted after basic research and pre- clinical development of the product; and
p.000235: (ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regu- latory
p.000235: requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act.
p.000235: (B) ACTIVITIES INCLUDED.—The term under subpara- graph (A) includes—
p.000235: (i) testing of the product to determine whether the product may be approved, cleared, or licensed under the
p.000235: Federal Food, Drug, and Cosmetic Act or under section 351 of this Act for a use that is or may be the basis for
p.000235: such product becoming a qualified counter- measure or qualified pandemic or epidemic product, or to help obtain
p.000235: such approval, clearance, or license;
p.000235: (ii) design and development of tests or models, in- cluding animal models, for such testing;
p.000235: (iii) activities to facilitate manufacture of the product on a commercial scale with consistently
p.000235: high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity;
p.000235: (iv) activities to improve the shelf-life of the prod- uct or technologies for administering the product; and
p.000235: (v) such other activities as are part of the ad- vanced stages of testing, refinement, improvement, or
p.000235: preparation of the product for such use and as are specified by the Secretary.
p.000235: (7) SECURITY COUNTERMEASURE.—The term ‘‘security coun- termeasure’’ has the meaning given such term in section 319F– 2.
p.000235:
p.000235:
p.000235:
p.000235: January 30, 2020
p.000235: (8) RESEARCH TOOL.—The term ‘‘research tool’’ means a de- vice, technology, biological material (including a cell line
p.000235: or an
p.000235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000235: the accelera- tion of countermeasure and product advanced research and de- velopment by—
p.000235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000237: PUBLIC HEALTH SERVICE ACT
p.000237: Sec. 319L
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p.000237: January 30, 2020
p.000237: (A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies,
p.000237: relevant industries, academia, and other persons, with re- spect to such advanced research and development;
p.000237: (B) promoting countermeasure and product advanced research and development;
p.000237: (C) facilitating contacts between interested persons and the offices or employees authorized by the
p.000237: Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and
p.000237: under section 351 of this Act; and
p.000237: (D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and de-
p.000237: velopment.
p.000237: (3) DIRECTOR.—The BARDA shall be headed by a Director (referred to in this section as the ‘‘Director’’) who
p.000237: shall be ap- pointed by the Secretary and to whom the Secretary shall dele- gate such functions and authorities as
p.000237: necessary to implement this section, including the execution of procurement contracts, grants, and cooperative
p.000237: agreements pursuant to this section.
p.000237: (4) DUTIES.—
p.000237: (A) COLLABORATION.—To carry out the purpose de- scribed in paragraph (2)(A), the Secretary shall—
p.000237: (i) facilitate and increase the expeditious and di- rect communication between the Department of
p.000237: Health and Human Services and relevant persons with respect to countermeasure and product advanced research
p.000237: and development, including by—
p.000237: (I) facilitating such communication regarding the processes for procuring such advanced re- search and
p.000237: development with respect to qualified countermeasures and qualified pandemic or epi- demic products of
p.000237: interest; and
p.000237: (II) soliciting information about and data from research on potential qualified countermeasures and qualified
p.000237: pandemic or epidemic products and related technologies;
p.000237: (ii) at least annually—
p.000237: (I) convene meetings with representatives from relevant industries, academia, other Federal agencies,
p.000237: international agencies as appropriate, and other interested persons;
p.000237: (II) sponsor opportunities to demonstrate the operation and effectiveness of relevant biodefense
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p.000237: (2)(B), the Secretary shall—
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p.000237: January 30, 2020
p.000237:
p.000237: (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified
p.000237: pandemic or epidemic products;
p.000237: (ii) direct and coordinate the countermeasure and product advanced research and development activities of
p.000237: the Department of Health and Human Services;
p.000237: (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and
p.000237: development (which may include advanced research and development for purposes of fulfilling require-
p.000237: ments under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as
p.000237: the Secretary may identify as priority unmet need areas; and
p.000237: (iv) award contracts, grants, cooperative agree- ments, and enter into other transactions, for counter-
p.000237: measure and product advanced research and develop- ment.
p.000237: (C) FACILITATING ADVICE.—To carry out the purpose described in paragraph (2)(C) the Secretary shall—
p.000237: (i) connect interested persons with the offices or employees authorized by the Secretary to advise such
p.000237: persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act and under
p.000237: section 351 of this Act related to the approval, clear- ance, or licensure of qualified
p.000237: countermeasures or qualified pandemic or epidemic products; and
p.000237: (ii) with respect to persons performing counter- measure and product advanced research and develop- ment
p.000237: funded under this section, enable such offices or employees to provide to the extent practicable such ad- vice in a
p.000237: manner that is ongoing and that is otherwise designed to facilitate expeditious development of quali- fied
p.000237: countermeasures and qualified pandemic or epi- demic products that may achieve such approval, clear- ance, or
p.000237: licensure.
p.000237: (D) SUPPORTING INNOVATION.—To carry out the pur- pose described in paragraph (2)(D), the Secretary may
p.000237: award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize
p.000237: payments, to promote—
p.000237: (i) innovation in technologies that may assist countermeasure and product advanced research and
p.000237: development;
p.000237: (ii) research on and development of research tools and other devices and technologies; and
p.000237: (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials,
p.000237: vaccine-manufacturing technologies, dose-sparing tech- nologies, efficacy-increasing technologies, platform
p.000237: technologies, technologies to administer counter- measures, and technologies to improve storage and
p.000237: transportation of countermeasures.
p.000237: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000237:
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p.000349: providing good nutrition (by the purchasing and prepara- tion of food).
p.000349: (3) In making grants and entering into contracts under this subsection, special consideration shall be given
p.000349: to entities which es- tablish or will establish programs to provide training for persons fifty years of age
p.000349: and older who wish to become paraprofessionals (including homemaker home health aides) to provide home
p.000349: health services.
p.000349: (4) Applications for grants and contracts under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and con- tracts under this subsection $2,000,000 for each of the
p.000349: fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and
p.000349: September 30, 1987.
p.000349: (c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee
p.000349: on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
p.000349: (1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such
p.000349: subsections were in ef- fect prior to October 1, 1981);
p.000349: (2) the need to continue grants and loans under sub- sections (a) and (b) (as such subsections are in
p.000349: effect on the day after the date of enactment of the Orphan Drug Act); and
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000349:
p.000349:
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p.000351: 351
p.000351: PUBLIC HEALTH SERVICE ACT
p.000351: Sec. 340
p.000351:
p.000351: (3) the extent to which standards have been applied to the training of personnel who provide home health services.
p.000351: (d) For purposes of this section, the term ‘‘home health serv- ices’’ has the meaning prescribed for
p.000351: the term by section 1861(m) of the Social Security Act.
p.000351: Subpart V—Healthy Communities Access Program
p.000351:
p.000351:
p.000351:
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p.000351: January 30, 2020
p.000351: SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFI- CIENCY, AND COORDINATION OF SERVICES FOR THE
p.000351: UN- INSURED AND UNDERINSURED.
p.000351: (a) IN GENERAL.—The Secretary may award grants to eligible entities to assist in the development of integrated
...

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p.000359: 359
p.000359: PUBLIC HEALTH SERVICE ACT
p.000359: Sec. 340B
p.000359:
p.000359: center (as that term is defined in section 1861(aa)(4) of the So- cial Security Act)), a health facility operated by or
p.000359: pursuant to a contract with the Indian Health Service, a hospital, a cancer center, a rural health clinic, an
p.000359: academic health center, or a nonprofit entity that enters into a partnership or coordinates referrals with
p.000359: such a center, clinic, facility, or hospital to pro- vide patient navigator services.
p.000359: (2) The term ‘‘health disparity population’’ means a popu- lation that, as determined by the Secretary,
p.000359: has a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or
p.000359: survival rates as compared to the health status of the general population.
p.000359: (3) The term ‘‘patient navigator’’ means an individual who has completed a training program approved by the
p.000359: Secretary to perform the duties listed in subsection (b).
p.000359: (m) AUTHORIZATION OF APPROPRIATIONS.—
p.000359: (1) IN GENERAL.—To carry out this section, there are au- thorized to be appropriated $2,000,000 for
p.000359: fiscal year 2006,
p.000359: $5,000,000 for fiscal year 2007, $8,000,000 for fiscal year 2008,
p.000359: $6,500,000 for fiscal year 2009, $3,500,000 for fiscal year 2010, and such sums as may be necessary for each
p.000359: of fiscal years 2011 through 2015.
p.000359: (2) AVAILABILITY.—The amounts appropriated pursuant to paragraph (1) shall remain available for obligation through
p.000359: the end of fiscal year 2015.
p.000359: Subpart VII—Drug Pricing Agreements 45
p.000359: LIMITATION ON PRICES OF DRUGS PURCHASED BY COVERED ENTITIES
p.000359: SEC. 340B. ø256b¿ (a) REQUIREMENTS FOR AGREEMENT WITH SECRETARY.—
p.000359: (1) IN GENERAL.—The Secretary shall enter into an agree- ment with each manufacturer of covered
p.000359: outpatient drugs under which the amount required to be paid (taking into ac- count any rebate or discount,
p.000359: as provided by the Secretary) to the manufacturer for covered outpatient drugs (other than drugs described in
p.000359: paragraph (3)) purchased by a covered enti- ty on or after the first day of the first month that begins after the date
p.000359: of the enactment of this section, does not exceed an amount equal to the average manufacturer price
p.000359: for the drug under title XIX of the Social Security Act in the preceding cal- endar quarter, reduced by the
p.000359: rebate percentage described in paragraph (2). Each such agreement shall require that the manufacturer
p.000359: furnish the Secretary with reports, on a quar- terly basis, of the price for each covered outpatient
p.000359: drug sub- ject to the agreement that, according to the manufacturer, rep- resents the maximum price that covered
p.000359: entities may permis- sibly be required to pay for the drug (referred to in this section as the ‘‘ceiling price’’),
p.000359: and shall require that the manufacturer offer each covered entity covered outpatient drugs for purchase
p.000359:
p.000359:
p.000359:
p.000359:
p.000359: January 30, 2020
p.000359: 45 So in law. Former subpart VI was repealed by section 4(a)(3) of Public Law 104–299 (110 Stat. 3645).
p.000359: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000359:
p.000359:
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p.000359: Sec. 340B PUBLIC HEALTH SERVICE ACT 360
p.000359:
p.000359: at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.
p.000359: (2) REBATE PERCENTAGE DEFINED.—
p.000359: (A) IN GENERAL.—For a covered outpatient drug pur- chased in a calendar quarter, the ‘‘rebate
p.000359: percentage’’ is the amount (expressed as a percentage) equal to—
p.000359: (i) the average total rebate required under section 1927(c) of the Social Security Act with respect to the
p.000359: drug (for a unit of the dosage form and strength in- volved) during the preceding calendar quarter; divided
p.000359: by
p.000359: (ii) the average manufacturer price for such a unit of the drug during such quarter.
p.000359: (B) OVER THE COUNTER DRUGS.—
p.000359: (i) IN GENERAL.—For purposes of subparagraph (A), in the case of over the counter drugs, the ‘‘rebate percentage’’
p.000359: shall be determined as if the rebate re- quired under section 1927(c) of the Social Security Act is based on
p.000359: the applicable percentage provided under section 1927(c)(3) of such Act.
p.000359: (ii) DEFINITION.—The term ‘‘over the counter drug’’ means a drug that may be sold without a pre-
p.000359: scription and which is prescribed by a physician (or other persons authorized to prescribe such drug under
p.000359: State law).
p.000359: (3) DRUGS PROVIDED UNDER STATE MEDICAID PLANS.— Drugs described in this paragraph are drugs purchased
p.000359: by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the
p.000359: Social Secu- rity Act.
p.000359: (4) COVERED ENTITY DEFINED.—In this section, the term ‘‘covered entity’’ means an entity that meets the
p.000359: requirements described in paragraph (5) and is one of the following:
p.000359: (A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act).
p.000359: (B) An entity receiving a grant under section 340A 46.
p.000359: (C) A family planning project receiving a grant or con- tract under section 1001.
p.000359: (D) An entity receiving a grant under subpart II of part C of title XXVI (relating to categorical grants for
p.000359: out- patient early intervention services for HIV disease).
p.000359: (E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under title XXVI.
p.000359: (F) A black lung clinic receiving funds under section 427(a) of the Black Lung Benefits Act.
p.000359: (G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the So-
p.000359: cial Security Act.
p.000359: (H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
p.000359: (I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act.
p.000359:
p.000359:
p.000359:
p.000359: January 30, 2020
p.000359: 46 See footnote on preceding page. See also footnote for section 217(a).
p.000359: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000359:
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p.000361: 361
p.000361: PUBLIC HEALTH SERVICE ACT
p.000361: Sec. 340B
p.000361:
p.000361: (J) Any entity receiving assistance under title XXVI (other than a State or unit of local government or an
p.000361: entity described in subparagraph (D)), but only if the entity is certified by the Secretary pursuant to
p.000361: paragraph (7).
p.000361: (K) An entity receiving funds under section 318 (relat- ing to treatment of sexually transmitted diseases) or
p.000361: sec- tion 317(j)(2) (relating to treatment of tuberculosis) through a State or unit of local government,
p.000361: but only if the entity is certified by the Secretary pursuant to paragraph (7).
p.000361:
...

p.000361: requirements of subparagraph (L), including the disproportionate share ad- justment percentage requirement under
p.000361: clause (ii) of such subparagraph, if the hospital were a subsection (d) hos- pital as defined by section
p.000361: 1886(d)(1)(B) of the Social Secu- rity Act.
p.000361: (N) An entity that is a critical access hospital (as de- termined under section 1820(c)(2) of the
p.000361: Social Security Act), and that meets the requirements of subparagraph (L)(i).
p.000361: (O) An entity that is a rural referral center, as defined by section 1886(d)(5)(C)(i) of the Social Security
p.000361: Act, or a sole community hospital, as defined by section 1886(d)(5)(C)(iii) of such Act,
p.000361: and that both meets the re- quirements of subparagraph (L)(i) and has a dispropor- tionate share
p.000361: adjustment percentage equal to or greater than 8 percent.
p.000361: (5) REQUIREMENTS FOR COVERED ENTITIES.—
p.000361: (A) PROHIBITING DUPLICATE DISCOUNTS OR REBATES.—
p.000361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000361:
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p.000361: Sec. 340B PUBLIC HEALTH SERVICE ACT 362
p.000361:
p.000361: (i) IN GENERAL.—A covered entity shall not re- quest payment under title XIX of the Social Security Act
p.000361: for medical assistance described in section 1905(a)(12) of such Act with respect to a drug
p.000361: that is subject to an agreement under this section if the drug is subject to the payment of a rebate to the
p.000361: State under section 1927 of such Act.
p.000361: (ii) ESTABLISHMENT OF MECHANISM.—The Sec- retary shall establish a mechanism to ensure that cov- ered
p.000361: entities comply with clause (i). If the Secretary does not establish a mechanism within 12 months under
p.000361: the previous sentence, the requirements of sec- tion 1927(a)(5)(C) of the Social Security Act shall
p.000361: apply.
p.000361: (B) PROHIBITING RESALE OF DRUGS.—With respect to any covered outpatient drug that is subject to an
p.000361: agree- ment under this subsection, a covered entity shall not re- sell or otherwise transfer the drug to
p.000361: a person who is not a patient of the entity.
p.000361: (C) AUDITING.—A covered entity shall permit the Sec- retary and the manufacturer of a covered outpatient
p.000361: drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures
p.000361: estab- lished by the Secretary relating to the number, duration, and scope of audits) to audit at the
p.000361: Secretary’s or the man- ufacturer’s expense the records of the entity that directly pertain to the entity’s
p.000361: compliance with the requirements described in subparagraphs (A) or (B) with respect to drugs of the
p.000361: manufacturer.
p.000361: (D) ADDITIONAL SANCTION FOR NONCOMPLIANCE.—If the Secretary finds, after audit as described in
p.000361: subpara- graph (C) and after notice and hearing, that a covered en- tity is in violation of a requirement
p.000361: described in subpara- graphs 47 (A) or (B), the covered entity shall be liable to the manufacturer of
p.000361: the covered outpatient drug that is the subject of the violation in an amount equal to the re- duction
p.000361: in the price of the drug (as described in subpara- graph (A)) provided under the agreement between the enti-
p.000361: ty and the manufacturer under this paragraph.
p.000361: (6) TREATMENT OF DISTINCT UNITS OF HOSPITALS.—In the case of a covered entity that is a distinct part of a
p.000361: hospital, the hospital shall not be considered a covered entity under this paragraph unless the hospital
p.000361: is otherwise a covered entity under this subsection.
p.000361: (7) CERTIFICATION OF CERTAIN COVERED ENTITIES.—
p.000361: (A) DEVELOPMENT OF PROCESS.—Not later than 60 days after the date of enactment of this subsection, the
p.000361: Secretary shall develop and implement a process for the certification of entities described in subparagraphs
p.000361: (J) and
p.000361: (K) of paragraph (4).
p.000361:
p.000361:
p.000361:
p.000361:
p.000361: January 30, 2020
p.000361: 47 So in law. See section 602(a) of Public Law 102–585 (106 Stat. 4967). Probably should be
p.000361: ‘‘subparagraph’’.
p.000361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000361:
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p.000363: 363
p.000363: PUBLIC HEALTH SERVICE ACT
p.000363: Sec. 340B
p.000363:
p.000363: (B) INCLUSION OF PURCHASE INFORMATION.—The proc- ess developed under subparagraph (A) shall include a re-
p.000363: quirement that an entity applying for certification under this paragraph submit information to the
p.000363: Secretary con- cerning the amount such entity expended for covered out- patient drugs in the preceding year so
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p.000363: of the descriptions under subparagraph (C), prepare and submit a report to the Secretary that contains a list of
p.000363: entities de- scribed in subparagraphs (J) and (K) of paragraph (4) that are located in the State.
p.000363: (E) RECERTIFICATION.—The Secretary shall require the recertification of entities certified pursuant to this
p.000363: para- graph on a not more frequent than annual basis, and shall require that such entities submit information to
p.000363: the Sec- retary to permit the Secretary to evaluate the validity of subsequent purchases by such entities in
p.000363: the same manner as that required under subparagraph (B).
p.000363: (8) DEVELOPMENT OF PRIME VENDOR PROGRAM.—The Sec- retary shall establish a prime vendor program under
p.000363: which covered entities may enter into contracts with prime vendors for the distribution of covered
p.000363: outpatient drugs. If a covered entity obtains drugs directly from a manufacturer, the manu- facturer shall
p.000363: be responsible for the costs of distribution.
p.000363: (9) NOTICE TO MANUFACTURERS.—The Secretary shall no- tify manufacturers of covered outpatient drugs and
p.000363: single State agencies under section 1902(a)(5) of the Social Security Act of the identities of covered
p.000363: entities under this paragraph, and of entities that no longer meet the requirements of paragraph (5) or that are
p.000363: no longer certified pursuant to paragraph (7).
p.000363: (10) NO PROHIBITION ON LARGER DISCOUNT.—Nothing in this subsection shall prohibit a manufacturer from
p.000363: charging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).
p.000363: (b) OTHER DEFINITIONS 48.—
p.000363: (1) IN GENERAL.—In this section, the terms ‘‘average man- ufacturer price’’, ‘‘covered outpatient drug’’, and
p.000363: ‘‘manufac- turer’’ have the meaning given such terms in section 1927(k) of the Social Security Act.
p.000363:
p.000363:
p.000363:
p.000363:
p.000363:
p.000363:
p.000363: January 30, 2020
p.000363: 48 The amendment made by section 7101(b)(2)(A) of Public Law 111–148 strikes ‘‘OTHER DEFI-
p.000363: NITION’’ and all that follows through ‘‘In this section’’ and inserts ‘‘OTHER DEFINITIONS.—
p.000363: (1) IN GENERAL.—In this section’’.
p.000363: The heading of such amendment should have been to strike ‘‘OTHER DEFINITIONS’’. The amendment made by
p.000363: such section has been carried out to reflect the probable intent of Con- gress.
p.000363: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000363:
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p.000363: Sec. 340B PUBLIC HEALTH SERVICE ACT 364
p.000363: (2) 49 COVERED DRUG.—In this section, the term ‘‘covered drug’’—
p.000363: (A) means a covered outpatient drug (as defined in section 1927(k)(2) of the Social Security Act); and
p.000363: (B) includes, notwithstanding paragraph (3)(A) of sec- tion 1927(k) of such Act, a drug used in
p.000363: connection with an inpatient or outpatient service provided by a hospital described in subparagraph (L),
p.000363: (M), (N), or (O) of sub- section (a)(4) that is enrolled to participate in the drug dis- count program under this
p.000363: section.
p.000363: (d) 50 IMPROVEMENTS IN PROGRAM INTEGRITY.—
p.000363: (1) MANUFACTURER COMPLIANCE.—
p.000363: (A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improve-
p.000363: ments in compliance by manufacturers with the require- ments of this section in order to prevent
p.000363: overcharges and other violations of the discounted pricing requirements specified in this section.
p.000363: (B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:
p.000363: (i) The development of a system to enable the Sec- retary to verify the accuracy of ceiling prices cal-
p.000363: culated by manufacturers under subsection (a)(1) and charged to covered entities, which shall include the
p.000363: following:
p.000363: (I) Developing and publishing through an ap- propriate policy or regulatory issuance, precisely defined
p.000363: standards and methodology for the cal- culation of ceiling prices under such subsection.
p.000363: (II) Comparing regularly the ceiling prices cal- culated by the Secretary with the quarterly pric- ing data that
p.000363: is reported by manufacturers to the Secretary.
p.000363: (III) Performing spot checks of sales trans- actions by covered entities.
p.000363: (IV) Inquiring into the cause of any pricing discrepancies that may be identified and either taking, or
p.000363: requiring manufacturers to take, such corrective action as is appropriate in response to such price
p.000363: discrepancies.
p.000363: (ii) The establishment of procedures for manufac- turers to issue refunds to covered entities in the event that
p.000363: there is an overcharge by the manufacturers, in- cluding the following:
p.000363: (I) Providing the Secretary with an expla- nation of why and how the overcharge occurred,
p.000363:
p.000363:
p.000363:
p.000363:
p.000363:
p.000363:
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p.000363:
p.000363:
p.000363: January 30, 2020
p.000363: 49 There are no references to the term ‘‘covered drug’’ in this section.
p.000363: 50 In law, there is no subsection (c) in section 340B of the Public Health Service Act. Sub- section
p.000363: (d) of section 340B of the Public Health Service, as in effect before the enactment of Pub- lic Law 111–148, was
p.000363: redesignated as subsection (c) by section 2501(f)(1)(C) of Public Law 111– 148, amended to read by section 7101(d) of
p.000363: Public Law 111–148, and stricken by section 2302(2) of Public Law 111–152. Subsection (d) of section 340B of the Public
p.000363: Health Service, as currently in effect, is shown according to the probable intent of the Congress. Section
p.000363: 7102(a) of Public Law 111–148 does not execute because it amends to read a nonexistent subsection (d). Notably,
p.000363: section 2302(3) of Public Law 111–152 assumes that section 7102(a) of Public Law 111–148 exe- cuted properly and makes
p.000363: amendments to subsection (d).
p.000363: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000363:
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p.000365: PUBLIC HEALTH SERVICE ACT
p.000365: Sec. 340B
p.000365:
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p.000365: how the refunds will be calculated, and to whom the refunds will be issued.
p.000365: (II) Oversight by the Secretary to ensure that the refunds are issued accurately and within a reasonable
p.000365: period of time, both in routine in- stances of retroactive adjustment to relevant pric- ing data and
p.000365: exceptional circumstances such as erroneous or intentional overcharging for covered outpatient drugs.
p.000365: (iii) The provision of access through the Internet website of the Department of Health and Human
p.000365: Services to the applicable ceiling prices for covered outpatient drugs as calculated and verified by the Sec-
p.000365: retary in accordance with this section, in a manner (such as through the use of password protection)
p.000365: that limits such access to covered entities and adequately assures security and protection of privileged
p.000365: pricing data from unauthorized re-disclosure.
p.000365: (iv) The development of a mechanism by which—
p.000365: (I) rebates and other discounts provided by manufacturers to other purchasers subsequent to the sale of
p.000365: covered outpatient drugs to covered en- tities are reported to the Secretary; and
p.000365: (II) appropriate credits and refunds are issued to covered entities if such discounts or rebates have the
p.000365: effect of lowering the applicable ceiling price for the relevant quarter for the drugs in- volved.
p.000365: (v) Selective auditing of manufacturers and whole- salers to ensure the integrity of the drug discount pro- gram under
p.000365: this section.
p.000365: (vi) The imposition of sanctions in the form of civil monetary penalties, which—
p.000365: (I) shall be assessed according to standards established in regulations to be promulgated by the Secretary
p.000365: not later than 180 days after the date of enactment of the Patient Protection and Affordable Care Act;
p.000365: (II) shall not exceed $5,000 for each instance of overcharging a covered entity that may have oc- curred; and
p.000365: (III) shall apply to any manufacturer with an agreement under this section that knowingly and intentionally
p.000365: charges a covered entity a price for purchase of a drug that exceeds the maximum ap- plicable price under
p.000365: subsection (a)(1).
p.000365: (2) COVERED ENTITY COMPLIANCE.—
p.000365: (A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improve-
p.000365: ments in compliance by covered entities with the require- ments of this section in order to prevent diversion
p.000365: and vio- lations of the duplicate discount provision and other re- quirements specified under subsection
p.000365: (a)(5).
p.000365: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000365: Sec. 340B PUBLIC HEALTH SERVICE ACT 366
p.000365:
p.000365: (B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:
p.000365: (i) The development of procedures to enable and require covered entities to regularly update (at least
p.000365: annually) the information on the Internet website of the Department of Health and Human Services relat-
p.000365: ing to this section.
p.000365: (ii) The development of a system for the Secretary to verify the accuracy of information regarding covered entities
p.000365: that is listed on the website described in clause (i).
p.000365: (iii) The development of more detailed guidance describing methodologies and options available to cov- ered
p.000365: entities for billing covered outpatient drugs to State Medicaid agencies in a manner that avoids du-
p.000365: plicate discounts pursuant to subsection (a)(5)(A).
p.000365: (iv) The establishment of a single, universal, and standardized identification system by which each cov-
p.000365: ered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for
p.000365: purposes of facilitating the ordering, purchasing, and delivery of covered outpatient drugs under this
p.000365: sec- tion, including the processing of chargebacks for such drugs.
p.000365: (v) The imposition of sanctions, in appropriate cases as determined by the Secretary, additional to those
p.000365: to which covered entities are subject under sub- section (a)(5)(D), through one or more of the following actions:
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p.000365: (I) Where a covered entity knowingly and in- tentionally violates subsection (a)(5)(B), the cov- ered
p.000365: entity shall be required to pay a monetary penalty to a manufacturer or manufacturers in the form of
p.000365: interest on sums for which the covered entity is found liable under subsection (a)(5)(D), such interest to
p.000365: be compounded monthly and equal to the current short term interest rate as determined by the Federal
p.000365: Reserve for the time period for which the covered entity is liable.
p.000365: (II) Where the Secretary determines a viola- tion of subsection (a)(5)(B) was systematic and egregious as
p.000365: well as knowing and intentional, re- moving the covered entity from the drug discount program under this
p.000365: section and disqualifying the entity from re-entry into such program for a rea- sonable period of time
p.000365: to be determined by the Secretary.
p.000365: (III) Referring matters to appropriate Federal authorities within the Food and Drug Administra- tion, the Office of
p.000365: Inspector General of Depart- ment of Health and Human Services, or other Federal agencies for
p.000365: consideration of appropriate action under other Federal statutes, such as the Prescription Drug Marketing
p.000365: Act (21 U.S.C. 353).
p.000365: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000367: 367
p.000367: PUBLIC HEALTH SERVICE ACT
p.000367: Sec. 340B
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p.000367: January 30, 2020
p.000367: (3) ADMINISTRATIVE DISPUTE RESOLUTION PROCESS.—
p.000367: (A) IN GENERAL.—Not later than 180 days after the date of enactment of the Patient Protection and Affordable
p.000367: Care Act, the Secretary shall promulgate regulations to es- tablish and implement an administrative process for
p.000367: the resolution of claims by covered entities that they have been overcharged for drugs purchased under
p.000367: this section, and claims by manufacturers, after the conduct of audits as authorized by subsection
p.000367: (a)(5)(C), of violations of sub- sections (a)(5)(A) or (a)(5)(B), including appropriate proce- dures for the
...

p.000367: that they have been charged prices for covered outpatient drugs in excess of the ceiling price de-
p.000367: scribed in subsection (a)(1), and claims by manufactur- ers that violations of subsection (a)(5)(A) or (a)(5)(B)
p.000367: have occurred;
p.000367: (ii) establish such deadlines and procedures as may be necessary to ensure that claims shall be re-
p.000367: solved fairly, efficiently, and expeditiously;
p.000367: (iii) establish procedures by which a covered entity may discover and obtain such information and docu- ments
p.000367: from manufacturers and third parties as may be relevant to demonstrate the merits of a claim that
p.000367: charges for a manufacturer’s product have exceeded the applicable ceiling price under this section, and
p.000367: may submit such documents and information to the administrative official or body responsible for adjudi-
p.000367: cating such claim;
p.000367: (iv) require that a manufacturer conduct an audit of a covered entity pursuant to subsection (a)(5)(C) as a
p.000367: prerequisite to initiating administrative dispute res- olution proceedings against a covered entity;
p.000367: (v) permit the official or body designated under clause (i), at the request of a manufacturer or manu-
p.000367: facturers, to consolidate claims brought by more than one manufacturer against the same covered
p.000367: entity where, in the judgment of such official or body, con- solidation is appropriate and consistent with the
p.000367: goals of fairness and economy of resources; and
p.000367: (vi) include provisions and procedures to permit multiple covered entities to jointly assert claims of
p.000367: overcharges by the same manufacturer for the same drug or drugs in one administrative proceeding, and
p.000367: permit such claims to be asserted on behalf of covered entities by associations or organizations representing
p.000367: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000367: Sec. 340C PUBLIC HEALTH SERVICE ACT 368
p.000367:
p.000367: the interests of such covered entities and of which the covered entities are members.
p.000367: (C) FINALITY OF ADMINISTRATIVE RESOLUTION.—The administrative resolution of a claim or claims under
p.000367: the regulations promulgated under subparagraph (A) shall be a final agency decision and shall be binding upon the
p.000367: par- ties involved, unless invalidated by an order of a court of competent jurisdiction.
p.000367: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000367: sums as may be necessary for fiscal year 2010 and each succeeding fiscal year.
p.000367: (e) 51 EXCLUSION OF ORPHAN DRUGS FOR CERTAIN COVERED EN- TITIES.—For covered entities described in
p.000367: subparagraph (M) (other than a children’s hospital described in subparagraph (M)), (N), or
p.000367: (O) of subsection (a)(4), the term ‘‘covered outpatient drug’’ shall not include a drug designated by
p.000367: the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or
p.000367: condition.
p.000367: Subpart VIII—Bulk Purchases of Vaccines for Certain Programs
p.000367: BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS
p.000367: SEC. 340C. ø256c¿ (a) AGREEMENTS FOR PURCHASES.—
p.000367: (1) IN GENERAL.—Not later than 180 days after the date of the enactment of the Preventive Health Amendments
p.000367: of 1992 52, the Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention and
p.000367: in consultation with the Administrator of the Health Resources and Services Administration, shall enter into
p.000367: negotiations with manufactur- ers of vaccines for the purpose of establishing and maintaining agreements under which
p.000367: entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in
p.000367: the agreements.
p.000367: (2) RELEVANT ENTITIES.—The entities referred to in para- graph (1) are entities that provide immunizations
p.000367: against vac- cine-preventable diseases with assistance provided under sec- tion 330.
p.000367: (b) NEGOTIATION OF PRICES.—In carrying out subsection (a), the Secretary shall, to the extent practicable,
p.000367: ensure that the prices provided for in agreements under such subsection are comparable to the prices
p.000367: provided for in agreements negotiated by the Sec- retary on behalf of grantees under section 317(j)(1).
p.000367: (c) AUTHORITY OF SECRETARY.—In carrying out subsection (a), the Secretary, in the discretion of the
p.000367: Secretary, may enter into the agreements described in such subsection (and may decline to enter
p.000367:
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p.000367: January 30, 2020
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p.000387: 387
p.000387: PUBLIC HEALTH SERVICE ACT
p.000387: Sec. 351
p.000387:
p.000387: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000387: sums as may be necessary for each of fiscal years 2011 through 2015.
p.000387: øPart E (secs. 341–347) repealed by section 3405(a) of Public Law 106–310 (as amended by section 110(b)
p.000387: of Public Law 114– 198).¿
p.000387:
p.000387: PART F—LICENSING—BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES 56
p.000387: Subpart 1—Biological Products
p.000387: REGULATION OF BIOLOGICAL PRODUCTS 57
p.000387: SEC. 351. ø262¿ (a)(1) No person shall introduce or deliver for introduction into interstate commerce any
p.000387: biological product un- less—
p.000387: (A) a biologics license under this subsection or subsection
p.000387: (k) is in effect for the biological product; and
p.000387: (B) each package of the biological product is plainly marked with—
p.000387: (i) the proper name of the biological product contained in the package;
p.000387: (ii) the name, address, and applicable license number of the manufacturer of the biological product; and
p.000387: (iii) the expiration date of the biological product.
p.000387: (2)(A) The Secretary shall establish, by regulation, require- ments for the approval, suspension, and
p.000387: revocation of biologics li- censes.
p.000387: (B) PEDIATRIC STUDIES.—A person that submits an ap- plication for a license under this paragraph shall submit
p.000387: to the Secretary as part of the application any assessments required under section 505B of the Federal Food,
p.000387: Drug, and Cosmetic Act.
p.000387: (C) The Secretary shall approve a biologics license applica- tion—
p.000387: (i) on the basis of a demonstration that—
p.000387: (I) the biological product that is the subject of the ap- plication is safe, pure, and potent; and
p.000387: (II) the facility in which the biological product is man- ufactured, processed, packed, or held meets standards
p.000387: de- signed to assure that the biological product continues to be safe, pure, and potent; and
p.000387: (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the
p.000387: subject of the appli- cation, in accordance with subsection (c).
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p.000387: January 30, 2020
p.000387: 56 Section 511(d) of Public Law 104–132 (110 Stat. 1284) relates to the regulatory control of biological
p.000387: agents and includes a requirement that the Secretary ‘‘establish and maintain a list of each biological
p.000387: agent that has the potential to pose a severe threat to public health and safe- ty’’.
p.000387: 57 Section 123(f) of Public Law 105–115 (111 Stat. 2324) provides as follows:
p.000387: ‘‘(f) SPECIAL RULE.—The Secretary of Health and Human Services shall take measures to min- imize differences in the
p.000387: review and approval of products required to have approved biologics li- cense applications under section 351 of the
p.000387: Public Health Service Act (42 U.S.C. 262) and prod- ucts required to have approved new drug applications under
p.000387: section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).’’.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000387: Sec. 351 PUBLIC HEALTH SERVICE ACT 388
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p.000387:
p.000387: (D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person
p.000387: that sub- mits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1
p.000387: of the Federal Food, Drug, and Cosmetic Act.
p.000387: (E)(i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental
p.000387: application, with respect to a qualified indication for a drug, submitted under this sub- section, if such
p.000387: supplemental application complies with the require- ments of subparagraph (B) of section 505(c)(5) of the Federal Food,
p.000387: Drug, and Cosmetic Act.
p.000387: (ii) In this subparagraph, the terms ‘‘qualified indication’’ and ‘‘qualified data summary’’ have the
p.000387: meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.
p.000387: (3) The Secretary shall prescribe requirements under which a biological product undergoing investigation
p.000387: shall be exempt from the requirements of paragraph (1).
p.000387: (b) No person shall falsely label or mark any package or con- tainer of any biological product or
p.000387: alter any label or mark on the package or container of the biological product so as to falsify the
p.000387: label or mark.
p.000387: (c) Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the
p.000387: purpose, may during all reasonable hours enter and inspect any establish- ment for the propagation or
p.000387: manufacture and preparation of any biological product.
p.000387: (d)(1) Upon a determination that a batch, lot, or other quantity of a product licensed under this section
p.000387: presents an imminent or substantial hazard to the public health, the Secretary shall issue an order
p.000387: immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this
p.000387: paragraph shall be issued in accordance with section 554 of title 5, United States Code.
p.000387: (2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per
p.000387: day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year
p.000387: beginning 1 year after the effective date of this para- graph, be increased by the percent change in the
p.000387: Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base
p.000387: quarter of the preceding year, adjusted to the nearest 1⁄10 of 1 percent. For purposes of this paragraph, the
p.000387: term ‘‘base quarter’’, as used with respect to a year, means the calendar quarter ending on September 30 of such
p.000387: year and the price index for a base quarter is the arithmetical mean of such index for the 3 months
p.000387: comprising such quarter.
p.000387: (e) No person shall interfere with any officer, agent, or em- ployee of the Service in the performance of any
p.000387: duty imposed upon him by this section or by regulations made by authority thereof.
p.000387: (f) Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be
p.000387: punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such
p.000387: fine and imprisonment, in the discretion of the court.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000389: 389
p.000389: PUBLIC HEALTH SERVICE ACT
p.000389: Sec. 351
p.000389:
p.000389: (g) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding
p.000389: the provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 1940 edition, title 21, ch. 9). 58
p.000389: (h) 59 A partially processed biological product which—
p.000389: (1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
p.000389: (2) is not intended for sale in the United States; and
p.000389: (3) is intended for further manufacture into final dosage form outside the United States,
p.000389: shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and
p.000389: Cosmetic Act (21 U.S.C. 321 et. seq.) if the product is manufactured, processed, packaged, and held in
p.000389: conformity with current good manufacturing practice requirements or meets international manufacturing
p.000389: standards as certified by an international standards organization recognized by the Secretary and meets the
p.000389: requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).
p.000389: (i) In this section:
p.000389: (1) The term ‘‘biological product’’ means a virus, thera- peutic serum, toxin, antitoxin, vaccine, blood, blood
p.000389: component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of
p.000389: arsphenamine (or any other trivalent organic arsenic compound), applicable to the preven- tion, treatment,
p.000389: or cure of a disease or condition of human beings.
p.000389: (2) The term ‘‘biosimilar’’ or ‘‘biosimilarity’’, in reference to a biological product that is the subject of an
p.000389: application under subsection (k), means—
p.000389: (A) that the biological product is highly similar to the reference product notwithstanding minor differences
p.000389: in clinically inactive components; and
p.000389: (B) there are no clinically meaningful differences be- tween the biological product and the reference
p.000389: product in terms of the safety, purity, and potency of the product.
p.000389: (3) The term ‘‘interchangeable’’ or ‘‘interchangeability’’, in reference to a biological product that is
p.000389: shown to meet the standards described in subsection (k)(4), means that the bio- logical product may be
p.000389: substituted for the reference product without the intervention of the health care provider who pre-
p.000389: scribed the reference product.
p.000389: (4) The term ‘‘reference product’’ means the single biologi- cal product licensed under subsection (a) against
p.000389: which a bio- logical product is evaluated in an application submitted under subsection (k).
p.000389: (j) The Federal Food, Drug, and Cosmetic Act, including the re- quirements under sections 505(o), 505(p), and
p.000389: 505–1 of such Act, applies to a biological product subject to regulation under this sec- tion, except that a
p.000389: product for which a license has been approved
p.000389:
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p.000389: January 30, 2020
p.000389: 58 Codification remains chapter 9 of title 21, United States Code (§ 301 et seq.).
p.000389: 59 Section 2102(d)(2) of title II of Public Law 104–134 (110 Stat. 1321-319) amended certain provisions in
p.000389: subsection (h). Subsequently, section 2104 of such Public Law (110 Stat. 1321-320) amended subsection (h) in its
p.000389: entirety. The above reflects only the latter amendment.
p.000389: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000389:
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p.000389: Sec. 351 PUBLIC HEALTH SERVICE ACT 390
p.000389:
p.000389: under subsection (a) shall not be required to have an approved ap- plication under section 505 of such Act.
p.000389: (k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
p.000389: INTERCHANGEABLE.—
p.000389: (1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this
p.000389: subsection.
p.000389: (2) CONTENT.—
p.000389: (A) IN GENERAL.—
p.000389: (i) REQUIRED INFORMATION.—An application sub- mitted under this subsection shall include information demonstrating
p.000389: that—
p.000389: (I) the biological product is biosimilar to a ref- erence product based upon data derived from—
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p.000391: (B) the applicant (or other appropriate person) con- sents to the inspection of the facility that is the subject
p.000391: of the application, in accordance with subsection (c).
p.000391: (4) SAFETY STANDARDS FOR DETERMINING INTERCHANGE- ABILITY.—Upon review of an application submitted under
p.000391: this subsection or any supplement to such application, the Sec- retary shall determine the biological product
p.000391: to be interchange- able with the reference product if the Secretary determines that the information submitted
p.000391: in the application (or a supple- ment to such application) is sufficient to show that—
p.000391: (A) the biological product—
p.000391: (i) is biosimilar to the reference product; and
p.000391: (ii) can be expected to produce the same clinical result as the reference product in any given patient;
p.000391: and
p.000391: (B) for a biological product that is administered more than once to an individual, the risk in terms
p.000391: of safety or diminished efficacy of alternating or switching between use of the biological product and
p.000391: the reference product is not greater than the risk of using the reference product without such alternation
p.000391: or switch.
p.000391: (5) GENERAL RULES.—
p.000391: (A) ONE REFERENCE PRODUCT PER APPLICATION.—A bi- ological product, in an application submitted under this
p.000391: subsection, may not be evaluated against more than 1 ref- erence product.
p.000391: (B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within
p.000391: the Food and Drug Administration that is responsible for the review and approval of the application under
p.000391: which the reference product is licensed.
p.000391: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000391: Sec. 351 PUBLIC HEALTH SERVICE ACT 392
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p.000391: January 30, 2020
p.000391:
p.000391: (C) RISK EVALUATION AND MITIGATION STRATEGIES.— The authority of the Secretary with respect to risk evalua-
p.000391: tion and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological
p.000391: products licensed under this subsection in the same manner as such authority applies to biological products licensed
p.000391: under sub- section (a).
p.000391: (6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.—Upon review of an application submitted under this
p.000391: subsection relying on the same reference product for which a prior biological product has received a
p.000391: determination of inter- changeability for any condition of use, the Secretary shall not make a
p.000391: determination under paragraph (4) that the second or subsequent biological product is interchangeable for any
p.000391: condi- tion of use until the earlier of—
p.000391: (A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be ap-
p.000391: proved as interchangeable for that reference product;
p.000391: (B) 18 months after—
p.000391: (i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the
p.000391: applicant that submitted the application for the first approved interchangeable biosimilar biological prod-
p.000391: uct; or
p.000391: (ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the
p.000391: applicant that submitted the application for the first approved interchangeable biosimilar biological prod-
p.000391: uct; or
p.000391: (C)(i) 42 months after approval of the first inter- changeable biosimilar biological product if
p.000391: the applicant that submitted such application has been sued under sub- section (l)(6) and such litigation is
p.000391: still ongoing within such 42-month period; or
...

p.000393:
p.000393:
p.000393:
p.000393:
p.000393: January 30, 2020
p.000393: (i) a supplement for the biological product that is the reference product; or
p.000393: (ii) a subsequent application filed by the same sponsor or manufacturer of the biological product that is the
p.000393: reference product (or a licensor, predecessor in interest, or other related entity) for—
p.000393: (I) a change (not including a modification to the structure of the biological product) that results in a new
p.000393: indication, route of administration, dos- ing schedule, dosage form, delivery system, deliv- ery device, or
p.000393: strength; or
p.000393: (II) a modification to the structure of the bio- logical product that does not result in a change in safety, purity, or
p.000393: potency.
p.000393: (D) DEEMED LICENSES.—
p.000393: (i) NO ADDITIONAL EXCLUSIVITY THROUGH DEEM- ING.—An approved application that is deemed to be a
p.000393: license for a biological product under this section pur- suant to section 7002(e)(4) of the Biologics Price Com-
p.000393: petition and Innovation Act of 2009 shall not be treat- ed as having been first licensed under subsection (a)
p.000393: for purposes of subparagraphs (A) and (B).
p.000393: (ii) APPLICATION OF LIMITATIONS ON EXCLU- SIVITY.—Subparagraph (C) shall apply with respect to
p.000393: a reference product referred to in such subparagraph that was the subject of an approved application
p.000393: that was deemed to be a license pursuant to section 7002(e)(4) of the Biologics Price Competition and
p.000393: Inno- vation Act of 2009.
p.000393: (iii) APPLICABILITY.—The exclusivity periods de- scribed in section 527, section 505A(b)(1)(A)(ii), and
p.000393: section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act shall continue to apply to a biological
p.000393: product after an approved application for the biological product is deemed to be a license for the biological
p.000393: product under subsection (a) pursuant to section 7002(e)(4) of the Biologics Price Competition and Inno-
p.000393: vation Act of 2009.
p.000393: (8) GUIDANCE DOCUMENTS.—
p.000393: (A) IN GENERAL.—The Secretary may, after oppor- tunity for public comment, issue guidance in
p.000393: accordance, except as provided in subparagraph (B)(i), with section 701(h) of the Federal Food, Drug, and
p.000393: Cosmetic Act with respect to the licensure of a biological product under this subsection. Any such
p.000393: guidance may be general or specific.
p.000393: (B) PUBLIC COMMENT.—
p.000393: (i) IN GENERAL.—The Secretary shall provide the public an opportunity to comment on any proposed guidance
p.000393: issued under subparagraph (A) before issuing final guidance.
p.000393: (ii) INPUT REGARDING MOST VALUABLE GUIDANCE.— The Secretary shall establish a process through which the public
p.000393: may provide the Secretary with input re- garding priorities for issuing guidance.
p.000393: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000393:
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p.000393: Sec. 351 PUBLIC HEALTH SERVICE ACT 394
p.000393:
p.000393: (C) NO REQUIREMENT FOR APPLICATION CONSIDER- ATION.—The issuance (or non-issuance) of guidance
p.000393: under subparagraph (A) shall not preclude the review of, or ac- tion on, an application submitted under this
p.000393: subsection.
p.000393: (D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUID- ANCE.—If the Secretary issues product class-specific guid-
p.000393: ance under subparagraph (A), such guidance shall include a description of—
p.000393: (i) the criteria that the Secretary will use to deter- mine whether a biological product is highly similar to a
p.000393: reference product in such product class; and
p.000393: (ii) the criteria, if available, that the Secretary will use to determine whether a biological product
...

p.000399: tion required under paragraph (2)(A), neither the reference product sponsor nor the subsection (k) applicant may, prior
p.000399: to the date notice is received under paragraph (8)(A), bring any action under section 2201 of title 28, United
p.000399: States Code, for a declaration of infringement, validity, or en- forceability of any patent that is
p.000399: described in clauses (i) and (ii) of paragraph (8)(B).
p.000399: (B) SUBSEQUENT FAILURE TO ACT BY SUBSECTION (k) APPLICANT.—If a subsection (k) applicant fails to
p.000399: complete an action required of the subsection (k) applicant under paragraph (3)(B)(ii), paragraph (5),
p.000399: paragraph (6)(C)(i), paragraph (7), or paragraph (8)(A), the reference product sponsor, but not the subsection
p.000399: (k) applicant, may bring an action under section 2201 of title 28, United States Code, for a declaration of
p.000399: infringement, validity, or enforceability of any patent included in the list described in paragraph (3)(A),
p.000399: including as provided under paragraph (7).
p.000399: (C) SUBSECTION (k) APPLICATION NOT PROVIDED.—If a subsection (k) applicant fails to provide the application and
p.000399: information required under paragraph (2)(A), the reference product sponsor, but not the subsection (k) applicant, may
p.000399: bring an action under section 2201 of title 28, United States Code, for a declaration of infringement,
p.000399: validity, or enforceability of any patent that claims the biological prod- uct or a use of the biological product.
p.000399: (m) PEDIATRIC STUDIES.—
p.000399: (1) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (h), (i), (j), (k),
p.000399: (l), (n), and (p) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the
p.000399: extension of a period under para- graphs (2) and (3) to the same extent and in the same manner as such provisions
p.000399: apply with respect to the extension of a pe- riod under subsection (b) or (c) of section 505A of the Federal
p.000399: Food, Drug, and Cosmetic Act.
p.000399: (2) MARKET EXCLUSIVITY FOR NEW BIOLOGICAL PRODUCTS.— If, prior to approval of an application that is
p.000399: submitted under
p.000399: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000401: 401
p.000401: PUBLIC HEALTH SERVICE ACT
p.000401: Sec. 351
p.000401:
p.000401: subsection (a), the Secretary determines that information relat- ing to the use of a new biological product in the
p.000401: pediatric popu- lation may produce health benefits in that population, the Sec- retary makes a written request for
p.000401: pediatric studies (which shall include a timeframe for completing such studies), the ap- plicant agrees to the
p.000401: request, such studies are completed using appropriate formulations for each age group for which the study is
p.000401: requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section
p.000401: 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act—
p.000401: (A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6
p.000401: months rather than 4 years and 12 years and 6 months rather than 12 years; and
p.000401: (B) if the biological product is designated under sec- tion 526 for a rare disease or condition, the period for
p.000401: such biological product referred to in section 527(a) is deemed to be 7 years and 6 months rather than 7 years.
p.000401: (3) MARKET EXCLUSIVITY FOR ALREADY-MARKETED BIOLOGI- CAL PRODUCTS.—If the Secretary determines that
p.000401: information relating to the use of a licensed biological product in the pedi- atric population may produce health
p.000401: benefits in that popu- lation and makes a written request to the holder of an ap- proved application
p.000401: under subsection (a) for pediatric studies (which shall include a timeframe for completing such studies), the
p.000401: holder agrees to the request, such studies are completed using appropriate formulations for each age
p.000401: group for which the study is requested within any such timeframe, and the re- ports thereof are submitted and
p.000401: accepted in accordance with section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act—
p.000401:
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p.000401: January 30, 2020
p.000401: (A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6
p.000401: months rather than 4 years and 12 years and 6 months rather than 12 years; and
p.000401: (B) if the biological product is designated under sec- tion 526 for a rare disease or condition, the period for
p.000401: such biological product referred to in section 527(a) is deemed to be 7 years and 6 months rather than 7 years.
p.000401: (4) EXCEPTION.—The Secretary shall not extend a period referred to in paragraph (2)(A), (2)(B), (3)(A),
p.000401: or (3)(B) if the determination under section 505A(d)(4) is made later than 9 months prior to the expiration
p.000401: of such period.
p.000401: (n) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON-
p.000401: TROLS UNDER THE CSA.—
p.000401: (1) IN GENERAL.—In the case of an application under sub- section (a) with respect to a biological
p.000401: product for which the Secretary provides notice to the sponsor that the Secretary in- tends to issue a
p.000401: scientific and medical evaluation and rec- ommend controls under the Controlled Substances Act, ap- proval
p.000401: of such application shall not take effect until the in- terim final rule controlling the biological
p.000401: product is issued in accordance with section 201(j) of the Controlled Substances Act.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000401:
p.000401:
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p.000407: (g) EXEMPTIONS.—
p.000407: (1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations under subsections (b) and (c) shall exempt clinical or
p.000407: diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are
p.000407: contained in specimens pre- sented for diagnosis, verification, or proficiency testing, pro- vided that—
p.000407: (A) the identification of such agents or toxins is re- ported to the Secretary, and when required under
p.000407: Federal,
p.000407: State, or local law, to other appropriate authorities; and
p.000407: (B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.
p.000407: (2) PRODUCTS.—
p.000407: (A) IN GENERAL.—Regulations under subsections (b) and (c) shall exempt products that are, bear, or
p.000407: contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts
p.000407: specified in subpara- graph (B), unless the Secretary by order determines that applying additional
p.000407: regulation under subsection (b) or (c) to a specific product is necessary to protect public health and
p.000407: safety.
p.000407: (B) RELEVANT LAWS.—For purposes of subparagraph (A), the Acts specified in this subparagraph are the fol-
p.000407: lowing:
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p.000407:
p.000407: January 30, 2020
p.000407: (i) The Federal Food, Drug, and Cosmetic Act.
p.000407: (ii) Section 351 of this Act.
p.000407: (iii) The Act commonly known as the Virus- Serum-Toxin Act (the eighth paragraph under the
p.000407: heading ‘‘Bureau of Animal Industry’’ in the Act of March 4, 1913; 21 U.S.C. 151–159).
p.000407: (iv) The Federal Insecticide, Fungicide, and Rodenticide Act.
p.000407: (C) INVESTIGATIONAL USE.—
p.000407: (i) IN GENERAL.—The Secretary may exempt an in- vestigational product that is, bears, or contains a list- ed agent or
p.000407: toxin from the applicability of provisions of regulations under subsection (b) or (c) when such product
p.000407: is being used in an investigation authorized under any Federal Act and the Secretary determines that
p.000407: applying additional regulation under subsection
p.000407: (b) or (c) to such product is not necessary to protect public health and safety.
p.000407: (ii) CERTAIN PROCESSES.—Regulations under sub- sections (b) and (c) shall set forth the procedures for
p.000407: applying for an exemption under clause (i). In the case of investigational products authorized under any of the
p.000407: Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption
p.000407: not later than 14 days after the first date
p.000407: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000407:
p.000407:
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p.000407: Sec. 351A PUBLIC HEALTH SERVICE ACT 408
p.000407:
...

p.000413: laboratory, including the number and types of laboratory examinations and other procedures performed, the
p.000413: methodologies for lab- oratory examinations and other procedures em- ployed, and the qualifications
p.000413: (educational back- ground, training, and experience) of the personnel directing and supervising the laboratory
p.000413: and per- forming the laboratory examinations and other procedures, and
p.000413: (III) that contains such other information as the Secretary may reasonably require to deter- mine
p.000413: compliance with this section, and
p.000413: (ii) the laboratory agrees to make records avail- able and submit reports to the Secretary as the Sec-
p.000413: retary may require.
p.000413: (B) CHANGES.—If a laboratory makes changes in the examinations and other procedures performed by it only
p.000413: with respect to examinations and procedures which are de- scribed in paragraph (3), the laboratory shall report
p.000413: such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory
p.000413: proposes to make changes in the examinations and procedures per- formed by it such that the laboratory
p.000413: will perform an ex- amination or procedure not described in paragraph (3), the laboratory shall report such change
p.000413: to the Secretary before the change takes effect.
p.000413: (C) EFFECT.—Subsections (f) and (g) shall not apply to a laboratory to which has been issued a certificate of waiv- er.
p.000413: (3) EXAMINATIONS AND PROCEDURES.—The examinations and procedures identified in paragraph (2) are
p.000413: laboratory ex- aminations and procedures that have been approved by the Food and Drug Administration for home
p.000413: use or that, as deter- mined by the Secretary, are simple laboratory examinations
p.000413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000413:
p.000413:
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p.000413:
p.000413: Sec. 353 PUBLIC HEALTH SERVICE ACT 414
p.000413:
p.000413: and procedures that have an insignificant risk of an erroneous result, including those that—
p.000413: (A) employ methodologies that are so simple and accu- rate as to render the likelihood of erroneous results by the user
p.000413: negligible, or
p.000413: (B) the Secretary has determined pose no unreason- able risk of harm to the patient if performed
p.000413: incorrectly.
p.000413: (4) DEFINITION.—As used in this section, the term ‘‘certifi- cate’’ includes a certificate of waiver issued
p.000413: under paragraph (2).
p.000413: (e) ACCREDITATION.—
p.000413: (1) IN GENERAL.—A laboratory may be accredited for pur- poses of obtaining a certificate if the laboratory—
p.000413: (A) meets the standards of an approved accreditation body, and
p.000413: (B) authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may des-
p.000413: ignate) such records or other information as the Secretary may require.
p.000413: (2) APPROVAL OF ACCREDITATION BODIES.—
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p.000445: years;
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p.000445: January 30, 2020
p.000445: SEC. 301. (a) It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer
p.000445: any human organ for valuable consideration for use in human transplantaion if the transfer affects
p.000445: interstate commerce.
p.000445: (b) Any person who violates subsection (a) shall be fined not more than $50,000 or imprisoned not more than five years,
p.000445: or both.
p.000445: (c) For purposes of subsection (a):
p.000445: (1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow,
p.000445: cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof,
p.000445: including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
p.000445: (2) The term ‘‘valuable consideration’’ does not include the reasonable payments associ- ated with the
p.000445: removal, transportation, implantation, processing, preservation, quality con- trol, and storage of a human
p.000445: organ or the expenses of travel, housing, and lost wages in- curred by the donor of a human organ in
p.000445: connection with the donation of the organ.
p.000445: (3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 201(b) of the Federal
p.000445: Food, Drug and Cosmetic Act.
p.000445: 76 So in law. Subparagraphs (D) and (E) have the same text, and there are two subparagraphs (H). This results from the
p.000445: same set of amendments to section 371(b)(1) being enacted twice. The first set of amendments was made by section
p.000445: 701(c) of Public Law 106–505 (114 Stat. 2347). These amendments redesignated subparagraphs (D) through (G) as
p.000445: subparagraphs (E) through (H), respectively, and then added a new subparagraph (D). The second set was made by section
p.000445: 219(b) of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000445: Appropriations Act, 2001 (as enacted into law by section 1(a)(1) of Public Law 106– 554; 114 Stat.
p.000445: 2763A–29). Per the second set of amendments, the subparagraph (D) added by the first set was
p.000445: redesignated as (E), and the same text was again added as a subparagraph (D). Per the second set,
p.000445: subparagraphs (F) and (G), as redesignated by the first set, were redes- ignated as (G) and (H), which resulted in
p.000445: there being two subparagraphs (H).
p.000445: 77 So in law. Probably should be ‘‘paragraph (3)’’.
p.000445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000445:
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p.000447: 447
p.000447: PUBLIC HEALTH SERVICE ACT
p.000447: Sec. 371
p.000447:
p.000447: (II) rely on outcome and process performance measures that are based on empirical evidence, ob-
...

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p.000451:
p.000451: Sec. 376 PUBLIC HEALTH SERVICE ACT 452
p.000451:
p.000451: (1) administer this part and coordinate with the organ pro- curement activities under title XVIII of the Social
p.000451: Security Act,
p.000451: (2) conduct a program of public information to inform the public of the need for organ donations,
p.000451: (3) provide technical assistance to organ procurement orga- nizations, the Organ Procurement and Transplantation
p.000451: Net- work established under section 372, and other entities in the health care system involved in organ
p.000451: donations, procurement, and transplants, and
p.000451: (4) provide information—
p.000451:
p.000451: (i) 82 to patients, their families, and their physicians about transplantation; and
p.000451: (ii) 82 to patients and their families about the re- sources available nationally and in each
p.000451: State, and the comparative costs and patient outcomes at each transplant center affiliated with the organ
p.000451: procurement and trans- plantation network, in order to assist the patients and families with the costs
p.000451: associated with transplantation.
p.000451: REPORT
p.000451: SEC. 376. ø274d¿ Not later than February 10 of 1991 and of each second year thereafter, the Secretary
p.000451: shall publish, and sub- mit to the Committee on Energy and Commerce of the House of Representatives and
p.000451: the Committee on Labor and Human Re- sources of the Senate. 83 a report on the scientific and clinical
p.000451: sta- tus of organ transplantation. The Secretary shall consult with the Director of the National Institutes of
p.000451: Health and the Commissioner of the Food and Drug Administration in the preparation of the re- port.
p.000451: SEC. 377. ø274f¿ REIMBURSEMENT OF TRAVEL AND SUBSISTENCE EX- PENSES INCURRED TOWARD LIVING ORGAN DONATION.
p.000451: (a) IN GENERAL.—The Secretary may award grants to States, transplant centers, qualified organ
p.000451: procurement organizations under section 371, or other public or private entities for the pur- pose of—
p.000451: (1) providing for the reimbursement of travel and subsist- ence expenses incurred by individuals toward
p.000451: making living donations of their organs (in this section referred to as ‘‘donat- ing individuals’’); and
p.000451: (2) providing for the reimbursement of such incidental non- medical expenses that are so incurred as the
p.000451: Secretary deter- mines by regulation to be appropriate.
p.000451: (b) PREFERENCE.—The Secretary shall, in carrying out sub- section (a), give preference to those
p.000451: individuals that the Secretary determines are more likely to be otherwise unable to meet such ex- penses.
p.000451: (c) CERTAIN CIRCUMSTANCES.—The Secretary may, in carrying out subsection (a), consider—
p.000451:
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p.000451: January 30, 2020
p.000451: 82 Clauses (i) and (ii) probably should be redesignated as subparagraphs (A) and (B). See sec- tion 204(b)(2) of Public
p.000451: Law 101–616 (104 Stat. 3285).
p.000451: 83 So in law. There probably should be a comma after ‘‘Senate’’ rather than a period. See sec- tion 205 of Public Law
p.000451: 101–616.
p.000451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000459:
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p.000459: January 30, 2020
p.000459: the terms of approximately one-third of the members of the Advisory Council expire.
p.000459: (4) The membership of the Advisory Council—
p.000459: (A) shall include as voting members a balanced num- ber of representatives including representatives of marrow
p.000459: donor centers and marrow transplant centers, representa- tives of cord blood banks and participating
p.000459: birthing hos- pitals, recipients of a bone marrow transplant, recipients of a cord blood transplant, persons
p.000459: who require such trans- plants, family members of such a recipient or family mem- bers of a patient who has
p.000459: requested the assistance of the Program in searching for an unrelated donor of bone mar- row or cord blood,
p.000459: persons with expertise in bone marrow and cord blood transplantation, persons with expertise in typing,
p.000459: matching, and transplant outcome data analysis, persons with expertise in the social sciences, basic sci-
p.000459: entists with expertise in the biology of adult stem cells, and members of the general public; and
p.000459: (B) shall include as nonvoting members representa- tives from the Department of Defense Marrow Donor Re-
p.000459: cruitment and Research Program operated by the Depart- ment of the Navy, the Division of Transplantation
p.000459: of the Health Resources and Services Administration, the Food and Drug Administration, and the National
p.000459: Institutes of Health.
p.000459: (5) Members of the Advisory Council shall be chosen so as to ensure objectivity and balance and reduce the
p.000459: potential for conflicts of interest. The Secretary shall establish bylaws and procedures—
p.000459: (A) to prohibit any member of the Advisory Council who has an employment, governance, or financial
p.000459: affili- ation with a donor center, recruitment organization, trans- plant center, or cord blood bank from participating
p.000459: in any decision that materially affects the center, recruitment or- ganization, transplant center, or cord blood bank;
p.000459: and
p.000459: (B) to limit the number of members of the Advisory Council with any such affiliation.
p.000459: (6) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit
p.000459: to Congress an annual report on the activities carried out under this section.
p.000459: (b) ACCREDITATION.—The Secretary shall, through a public process, recognize one or more accreditation
p.000459: entities for the accredi- tation of cord blood banks.
p.000459: (c) INFORMED CONSENT.—The Secretary shall, through a public process, examine issues of informed consent, including—
p.000459: (1) the appropriate timing of such consent; and
p.000459: (2) the information provided to the maternal donor regard- ing all of her medically appropriate cord blood options.
p.000459: Based on such examination, the Secretary shall require that the standards used by the accreditation entities
...

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p.000461: 461
p.000461: PUBLIC HEALTH SERVICE ACT
p.000461: Sec. 379
p.000461:
p.000461: matched to a particular patient through the office estab- lished under subsection (h);
p.000461: (I) with respect to searches for unrelated donors of bone marrow that are conducted through the system under
p.000461: subparagraph (A), collect, analyze, and publish data in a standardized electronic format on the number and
p.000461: percent- age of patients at each of the various stages of the search process, including data regarding the
p.000461: furthest stage reached, the number and percentage of patients who are unable to complete the search process,
p.000461: and the reasons un- derlying such circumstances;
p.000461: (J) support studies and demonstration and outreach projects for the purpose of increasing the number of
p.000461: indi- viduals who are willing to be marrow donors to ensure a genetically diverse donor pool; and
p.000461: (K) facilitate research with the appropriate Federal agencies to improve the availability, efficiency, safety,
p.000461: and cost of transplants from unrelated donors and the effec- tiveness of Program operations.
p.000461: (2) CORD BLOOD FUNCTIONS.—
p.000461: (A) IN GENERAL.—With respect to cord blood, the Pro- gram shall—
p.000461: (i) 85 operate a system for identifying, matching, and facilitating the distribution of donated cord
p.000461: blood units that are suitably matched to candidate patients and meet all applicable Federal and State
p.000461: regulations (including in- formed consent and Food and Drug Administration regula- tions) from a qualified cord blood
p.000461: bank;
p.000461: (ii) 85 consistent with paragraph (3), allow transplant physicians, other appropriate health care
p.000461: professionals, and patients to search by means of electronic access all available cord blood units made
p.000461: available through the Pro- gram;
p.000461: (iii) 85 allow transplant physicians and other appro- priate health care professionals to reserve, as
p.000461: defined by the Secretary, a cord blood unit for transplantation;
p.000461: (iv) support and expand new and existing studies and demonstration and outreach projects for the pur-
p.000461: pose of increasing cord blood unit donation and collec- tion from a genetically diverse population and expand- ing
p.000461: the number of cord blood unit collection sites partnering with cord blood banks receiving a
p.000461: contract under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and
p.000461: Re- search Act of 2005, including such studies and projects that focus on—
p.000461: (I) remote collection of cord blood units, con- sistent with the requirements under the Program and the
p.000461: National Cord Blood Inventory program
p.000461:
p.000461:
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p.000461:
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p.000461: 85 Margin so in law. The amendment by section 2(b)(2)(A)(ii) of Public Law 111–264 redesig- nates
p.000461: subpargraphs (A)–(H) as clauses (i)–(viii); however, the amendment did not move the mar- gins of such clauses to the
p.000461: right so that it appears indented 6 ems from the left margin (except for clause (iv) which was amended in its
...

p.000463: (C) DEFINITION.—In this paragraph, the term ‘‘remote collection’’ means the collection of cord blood units at
p.000463: loca- tions that do not have written contracts with cord blood banks for collection support.
p.000463: (3) SINGLE POINT OF ACCESS; STANDARD DATA.—
p.000463: (A) SINGLE POINT OF ACCESS.—The Secretary shall en- sure that health care professionals and patients are able
p.000463: to search electronically for and facilitate access to, in the manner and to the extent defined by the
p.000463: Secretary and consistent with the functions described in paragraphs (1)(A) and (2)(A)(i), cells from
p.000463: bone marrow donors and cord blood units through a single point of access.
p.000463: (B) STANDARD DATA.—The Secretary shall require all recipients of contracts under this section to make available a
p.000463: standard dataset for purposes of subparagraph (A) in a standardized electronic format that enables
p.000463: transplant physicians to compare among and between bone marrow donors and cord blood units to ensure the
p.000463: best possible match for the patient.
p.000463: (4) DEFINITION.—The term ‘‘qualified cord blood bank’’ means a cord blood bank that—
p.000463: (A) has obtained all applicable Federal and State li- censes, certifications, registrations (including
p.000463: pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate
p.000463: and maintain a cord blood bank;
p.000463: (B) has implemented donor screening, cord blood col- lection practices, and processing methods intended to
p.000463: pro- tect the health and safety of donors and transplant recipi- ents to improve transplant outcomes, including
p.000463: with re- spect to the transmission of potentially harmful infections and other diseases;
p.000463: (C) is accredited by an accreditation entity recognized by the Secretary under subsection (b);
p.000463: (D) has established a system of strict confidentiality to protect the identity and privacy of patients and
p.000463: donors in accordance with existing Federal and State law;
p.000463: (E) has established a system for encouraging donation by a genetically diverse group of donors; and
p.000463: (F) has established a system to confidentially maintain linkage between a cord blood unit and a maternal
p.000463: donor.
p.000463: (e) BONE MARROW RECRUITMENT; PRIORITIES; INFORMATION AND EDUCATION.—
p.000463: (1) RECRUITMENT; PRIORITIES.—The Program shall carry out activities for the recruitment of bone marrow donors.
p.000463: Such recruitment program shall identify populations that are under- represented among potential donors enrolled
p.000463: with the Pro- gram. In the case of populations that are identified under the preceding sentence:
p.000463: (A) The Program shall give priority to carrying out ac- tivities under this part to increase representation for such
p.000463: populations in order to enable a member of such a popu-
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000463:
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p.000469: (1) enter into agreements between the Service and public and private community health agencies which provide
p.000469: for coop- erative planning of activities to deal with problems relating to the prevention and control of injuries;
p.000469: (2) work in cooperation with other Federal agencies, and with public and nonprofit private entities, to promote
p.000469: activities regarding the prevention and control of injuries; and
p.000469: (3) make grants to States and, after consultation with State health agencies, to other public or nonprofit
p.000469: private enti- ties for the purpose of carrying out demonstration projects for the prevention and control of
p.000469: injuries at sites that are not sub- ject to the Occupational Safety and Health Act of 1970, includ- ing homes,
p.000469: elementary and secondary schools, and public build- ings.
p.000469: SEC. 392A. ø280b–1¿ PREVENTING OVERDOSES OF CONTROLLED SUB- STANCES.
p.000469: (a) EVIDENCE-BASED PREVENTION GRANTS.—
p.000469: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000469: (A) to the extent practicable, carry out and expand any evidence-based prevention activities described in
p.000469: para- graph (2);
p.000469: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000469: out such activity; and
p.000469: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity.
p.000469: (2) EVIDENCE-BASED PREVENTION ACTIVITIES.—An evidence- based prevention activity described in this paragraph is any
p.000469: of the following activities:
p.000469: (A) Improving the efficiency and use of a new or cur- rently operating prescription drug monitoring program,
p.000469: in- cluding by—
p.000469: (i) encouraging all authorized users (as specified by the State or other entity) to register with and
p.000469: use the program;
p.000469: (ii) enabling such users to access any updates to information collected by the program in as close to
p.000469: real-time as possible;
p.000469: (iii) improving the ease of use of such program;
p.000469: (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of
p.000469: controlled substances and any detection of in- appropriate prescribing or dispensing practices relat- ing to such
p.000469: substances;
p.000469: (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identi-
p.000469: fied, aggregate reports based on such analysis to State public health agencies, State substance abuse agen- cies,
p.000469: State licensing boards, and other appropriate
p.000469: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: 471
p.000471: PUBLIC HEALTH SERVICE ACT
p.000471: Sec. 392A
p.000471:
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p.000471: State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug
p.000471: monitoring program and not containing any protected health information, to prevent inappropriate pre-
p.000471: scribing, drug diversion, or abuse and misuse of con- trolled substances, and to facilitate better coordination
p.000471: among agencies;
p.000471: (vi) enhancing interoperability between the pro- gram and any health information technology (includ- ing
p.000471: certified health information technology), including by integrating program data into such technology;
p.000471: (vii) updating program capabilities to respond to technological innovation for purposes of appropriately
p.000471: addressing the occurrence and evolution of controlled substance overdoses;
p.000471: (viii) facilitating and encouraging data exchange between the program and the prescription drug moni- toring
p.000471: programs of other States;
p.000471: (ix) enhancing data collection and quality, includ- ing improving patient matching and proactively moni- toring
p.000471: data quality;
p.000471: (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports
p.000471: for practitioners to review their prescribing patterns in comparison to such patterns of other
p.000471: practitioners in the specialty; and
p.000471: (xi) meeting the purpose of the program estab- lished under section 399O, as described in section
p.000471: 399O(a).
p.000471: (B) Promoting community or health system interven- tions.
p.000471: (C) Evaluating interventions to prevent controlled sub- stance overdoses.
p.000471: (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging
p.000471: public health crises and opportunities to address such cri- ses, such as enhancing public education and awareness on
p.000471: the risks associated with opioids.
p.000471: (3) ADDITIONAL GRANTS.—The Director may award grants to States, localities, and Indian Tribes—
p.000471: (A) to carry out innovative projects for grantees to rap- idly respond to controlled substance misuse, abuse,
p.000471: and overdoses, including changes in patterns of controlled sub- stance use; and
p.000471: (B) for any other evidence-based activity for pre- venting controlled substance misuse, abuse, and
...

p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
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p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
p.000491: drug treatment services, and the utilization of such services provided by the grantee; and
p.000491: (9) the incidence of developmental disabilities.
p.000491: (n) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under subsection (a) only if—
p.000491: (1) an application for the grant is submitted to the Sec- retary;
p.000491: (2) the application contains the agreements and assur- ances required in this section, and the information
p.000491: required in subsection (j);
p.000491: (3) the application contains evidence that the preparation of the application has been coordinated with the
p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
...

p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
...

p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: Sec. 399A PUBLIC HEALTH SERVICE ACT 498
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
...

p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: 499
p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
...

p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: Sec. 399A PUBLIC HEALTH SERVICE ACT 500
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p.000501: Sec. 399A PUBLIC HEALTH SERVICE ACT 502
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
...

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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
...

p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
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p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: 505
p.000505: PUBLIC HEALTH SERVICE ACT
p.000505: Sec. 399A
p.000505:
p.000505: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for health,
p.000505: including maternal and child health 95 mental health, child welfare, edu- cation, juvenile justice, developmental
p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
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p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
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p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
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p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
p.000527: INFANTS, AND YOUNG CHILDREN.
p.000527: (a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND
p.000527: SYS-
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p.000533: of per- sons who experience childhood cancers in order to prevent or minimize the disabling nature of these
p.000533: cancers.
p.000533: (c) COORDINATION OF ACTIVITIES.—The Secretary shall assure that activities under this section are
p.000533: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities focused on
p.000533: childhood cancers and limb loss.
p.000533: (d) DEFINITION.—For purposes of this section, the term ‘‘child- hood cancer’’ refers to a spectrum of
p.000533: different malignancies that
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: Sec. 399O PUBLIC HEALTH SERVICE ACT 534
p.000533:
p.000533: vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this
p.000533: section revise the definition of such term to the extent determined by the Secretary to be appro-
p.000533: priate.
p.000533: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000533: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000533: SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
p.000533: (a) PROGRAM.—
p.000533: (1) IN GENERAL.—Each fiscal year, the Secretary, acting through the Director of the Centers for Disease
p.000533: Control and Prevention, in coordination with the heads of other depart- ments and agencies as appropriate,
p.000533: shall support States or lo- calities for the purpose of improving the efficiency and use of PDMPs, including—
p.000533: (A) establishment and implementation of a PDMP;
p.000533: (B) maintenance of a PDMP;
p.000533: (C) improvements to a PDMP by—
p.000533: (i) enhancing functional components to work to- ward—
p.000533: (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow;
p.000533: (II) more timely inclusion of data within a PDMP;
p.000533: (III) active management of the PDMP, in part by sending proactive or unsolicited reports to pro- viders to inform
p.000533: prescribing; and
p.000533: (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates,
p.000533: to the extent that State laws allow;
p.000533: (ii) in consultation with the Office of the National Coordinator for Health Information Technology, im- proving
p.000533: the intrastate interoperability of PDMPs by—
p.000533: (I) making PDMPs more actionable by inte- grating PDMPs within electronic health records and health
p.000533: information technology infrastructure; and
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p.000533: (II) linking PDMP data to other data systems
p.000533: within the State, including—
...

p.000535: reporting oc- curs not later than 24 hours after the dispensing event;
p.000535: (2) the consultation of the PDMP by each prescribing prac- titioner, or their designee, in the State or
p.000535: locality before initi- ating treatment with a controlled substance, or any substance as required by the State
p.000535: to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event;
p.000535: (3) the consultation of the PDMP before dispensing a con- trolled substance, or any substance as required by the State
p.000535: to be reported to the PDMP;
p.000535: (4) the proactive notification to a practitioner when pat- terns indicative of controlled substance misuse by a
p.000535: patient, in- cluding opioid misuse, are detected;
p.000535: (5) the availability of data in the PDMP to other States, as allowable under State law; and
p.000535: (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for
p.000535: surveillance, epidemiology, statistical research, or educational purposes.
p.000535: (c) DRUG MISUSE AND ABUSE.—In consultation with practi- tioners, dispensers, and other relevant and interested
p.000535: stakeholders, a State receiving support under this section—
p.000535: (1) shall establish a program to notify practitioners and dispensers of information that will help to identify
p.000535: and prevent the unlawful diversion or misuse of controlled substances;
p.000535: (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for
p.000535: carrying out drug diversion investigations if the State determines that informa- tion in the PDMP maintained
p.000535: by the State indicates an unlaw- ful diversion or abuse of a controlled substance;
p.000535: (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State
p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000537: delivery.
p.000537: (3) The term ‘‘dispenser’’ means a physician, pharmacist, or other person that dispenses a controlled substance
p.000537: to an ul- timate user.
p.000537: (4) The term ‘‘interstate interoperability’’ with respect to a PDMP means the ability of the PDMP to
p.000537: electronically share reported information with another State if the information con- cerns either the dispensing of a
p.000537: controlled substance to an ulti- mate user who resides in such other State, or the dispensing of a
p.000537: controlled substance prescribed by a practitioner whose principal place of business is located in such other
p.000537: State.
p.000537: (5) The term ‘‘intrastate interoperability’’ with respect to a PDMP means the integration of PDMP data within
p.000537: electronic health records and health information technology infrastruc- ture or linking of a PDMP to other
p.000537: data systems within the State, including the State’s Medicaid program, workers’ com- pensation programs, and
p.000537: medical examiners or coroners.
p.000537: (6) The term ‘‘nonidentifiable information’’ means informa- tion that does not identify a practitioner, dispenser, or
p.000537: an ulti- mate user and with respect to which there is no reasonable basis to believe that the
p.000537: information can be used to identify a practitioner, dispenser, or an ultimate user.
p.000537: (7) The term ‘‘PDMP’’ means a prescription drug moni- toring program that is State-controlled.
p.000537: (8) The term ‘‘practitioner’’ means a physician, dentist, vet- erinarian, scientific investigator, pharmacy,
p.000537: hospital, or other person licensed, registered, or otherwise permitted, by the United States or the
p.000537: jurisdiction in which the individual prac- tices or does research, to distribute, dispense, conduct research with
p.000537: respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of
p.000537: professional practice or research.
p.000537: (9) The term ‘‘State’’ means each of the 50 States, the Dis- trict of Columbia, and any commonwealth or
p.000537: territory of the United States.
p.000537: (10) The term ‘‘ultimate user’’ means a person who has ob- tained from a dispenser, and who possesses, a
p.000537: controlled sub- stance for the person’s own use, for the use of a member of the person’s household, or for the
p.000537: use of an animal owned by the person or by a member of the person’s household.
p.000537: (11) The term ‘‘clinical workflow’’ means the integration of automated queries for prescription drug monitoring
p.000537: programs
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000537:
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p.000539: 539
p.000539: PUBLIC HEALTH SERVICE ACT
p.000539: Sec. 399P
p.000539:
p.000539: data and analytics into health information technologies such as electronic health record systems, health information
p.000539: exchanges, and/or pharmacy dispensing software systems, thus stream- lining provider access through automated
p.000539: queries.
p.000539: SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYS- TEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING
p.000539: VIO- LENCE, SEXUAL ASSAULT, AND STALKING.
p.000539: (a) IN GENERAL.—The Secretary shall award grants for—
p.000539: (1) the development or enhancement and implementation of interdisciplinary training for health
p.000539: professionals, public health staff, and allied health professionals;
p.000539: (2) the development or enhancement and implementation of education programs for medical, nursing, dental,
p.000539: and other health profession students and residents to prevent and re- spond to domestic violence, dating
p.000539: violence, sexual assault, and stalking; and
p.000539: (3) the development or enhancement and implementation of comprehensive statewide strategies to improve the
...

p.000583: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000583: Sec. 399CC PUBLIC HEALTH SERVICE ACT 584
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p.000583: January 30, 2020
p.000583:
p.000583: (A) the Director of the Centers for Disease Control and Prevention;
p.000583: (B) the Director of the National Institutes of Health, and the Directors of such national research
p.000583: institutes of the National Institutes of Health as the Secretary deter- mines appropriate;
p.000583: (C) the heads of such other agencies as the Secretary determines appropriate, such as the Administration
p.000583: for Community Living, Administration for Children and Fami- lies, the Centers for Medicare & Medicaid Services,
p.000583: the Food and Drug Administration, and the Health Resources and Services Administration; and
p.000583: (D) representatives of other Federal Governmental agencies that serve individuals with autism spectrum
p.000583: dis- order such as the Department of Education, the Depart- ment of Labor, the Department of Justice, the
p.000583: Department of Veterans Affairs, the Department of Housing and Urban Development, and the Department of Defense.
p.000583: (2) NON-FEDERAL MEMBERS.—Not more than 1⁄2, but not fewer than 1⁄3, of the total membership of the Committee,
p.000583: shall be composed of non-Federal public members to be appointed by the Secretary, of which—
p.000583: (A) at least three such members shall be individuals with a diagnosis of autism spectrum disorder;
p.000583: (B) at least three such members shall be parents or legal guardians of an individual with an autism
p.000583: spectrum disorder; and
p.000583: (C) at least three such members shall be representa- tives of leading research, advocacy, and service
p.000583: organiza- tions for individuals with autism spectrum disorder.
p.000583: (3) PERIOD OF APPOINTMENT; VACANCIES.—
p.000583: (A) PERIOD OF APPOINTMENT FOR NON-FEDERAL MEM- BERS.—Non-Federal members shall serve for a term of 4
p.000583: years, and may be reappointed for one additional 4-year term.
p.000583: (B) VACANCIES.—A vacancy on the Committee shall be filled in the manner in which the original appointment was
p.000583: made and shall not affect the powers or duties of the Committee. Any member appointed to fill a vacancy for an
...

p.000597:
p.000597: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out sub- sections (a), (b), (c)(1), and (d), there are
p.000597: authorized to be appro- priated $4,900,000 for each of fiscal years 2015 through 2019.
p.000597: TITLE IV—NATIONAL RESEARCH INSTITUTES PART A—NATIONAL INSTITUTES OF HEALTH
p.000597: SEC. 401. ø281¿ ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
p.000597: (a) RELATION TO PUBLIC HEALTH SERVICE.—The National Insti- tutes of Health is an agency of the Service. 1
p.000597: (b) NATIONAL RESEARCH INSTITUTES AND NATIONAL CENTERS.— The following agencies of the National Institutes of
p.000597: Health are na- tional research institutes or national centers:
p.000597: (1) The National Cancer Institute.
p.000597: (2) The National Heart, Lung, and Blood Institute.
p.000597: (3) The National Institute of Diabetes and Digestive and Kidney Diseases.
p.000597: (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
p.000597: (9) The National Eye Institute.
p.000597: (10) The National Institute of Neurological Disorders and Stroke.
p.000597: (11) The National Institute on Deafness and Other Com- munication Disorders.
p.000597: (12) The National Institute on Alcohol Abuse and Alco- holism.
p.000597: (13) The National Institute on Drug Abuse.
p.000597: (14) The National Institute of Mental Health.
p.000597: (15) The National Institute of General Medical Sciences.
p.000597: (16) The National Institute of Environmental Health Sciences.
p.000597: (17) The National Institute of Nursing Research.
p.000597: (18) The National Institute of Biomedical Imaging and Bio- engineering.
p.000597: (19) The National Human Genome Research Institute.
p.000597: (20) The National Library of Medicine.
p.000597: (21) The National Center for Advancing Translational Sciences.
p.000597: (22) The John E. Fogarty International Center for Ad- vanced Study in the Health Sciences.
p.000597:
p.000597:
p.000597:
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p.000597:
p.000597:
p.000597: January 30, 2020
p.000597: 1 See footnote for section 202.
p.000597: 2 Section 212 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000597: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–359)
p.000597: amended subparagraph (H) to read as provided above, there- by indicating the intent of the Congress to change the
p.000597: designation of the Institute. (The former designation was the National Institute of Dental Research.) Conforming
p.000597: changes were not, how- ever, made to section 453 or the related subpart heading, or to the reference in section
p.000597: 409A(a).
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000609: Sec. 402 PUBLIC HEALTH SERVICE ACT 610
p.000609:
p.000609: and conditions (in this subsection referred to as the ‘‘data bank’’). The activities of the data bank shall
p.000609: be integrated and coordinated with related activities of other agencies of the Department of Health and Human
p.000609: Services, and to the extent practicable, coordi- nated with other data banks containing similar information.
p.000609: (B) The Secretary shall establish the data bank after consulta- tion with the Commissioner of Food and Drugs, the
p.000609: directors of the appropriate agencies of the National Institutes of Health (including the National Library of
p.000609: Medicine), and the Director of the Centers for Disease Control and Prevention.
p.000609: (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the
p.000609: information described in such paragraph. The Secretary shall disseminate such information through
p.000609: information systems, which shall include toll-free tele- phone communications, available to individuals with
p.000609: serious or life- threatening diseases and conditions, to other members of the pub- lic, to health care
p.000609: providers, and to researchers.
p.000609: (3) The data bank shall include the following:
p.000609: (A) A registry of clinical trials (whether federally or pri- vately funded) of experimental treatments
p.000609: for serious or life- threatening diseases and conditions under regulations promul- gated pursuant to section 505(i)
p.000609: of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each experimental
p.000609: drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Informa-
p.000609: tion provided shall consist of eligibility criteria for participa- tion in the clinical trials, a
p.000609: description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and
p.000609: shall be in a form that can be readily understood by members of the public. 4 Such information shall be
p.000609: forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the
p.000609: protocol.
p.000609: (B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions
p.000609: that may be available—
p.000609: (i) under a treatment investigational new drug appli- cation that has been submitted to the Secretary under sec-
p.000609: tion 561(c) of the Federal Food, Drug, and Cosmetic Act; or
p.000609: (ii) as a Group C cancer drug (as defined by the Na- tional Cancer Institute).
p.000609: The data bank may also include information pertaining to the results of clinical trials of such treatments, with the
p.000609: consent of the sponsor, including information concerning potential toxicities or adverse effects
p.000609: associated with the use or adminis- tration of such experimental treatments.
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p.000609: January 30, 2020
p.000609: 4 Section 15(c)(2) of Public Law 107–109 (115 Stat. 1420) attempted to make amendments to the first
p.000609: sentence of subparagraph (A), but the amendments cannot be executed because the terms to be amended appear
p.000609: in the second sentence, not the first. The following shows the sec- ond sentence as it would appear if the amendments
p.000609: were executed to the second sentence: ‘‘In- formation provided shall consist of eligibility criteria for participation
p.000609: in the clinical trials, a de- scription of the location of trial sites, a point of contact for those wanting to enroll
p.000609: in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the
p.000609: investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards,
p.000609: for single-patient and expanded protocol use of the new drug, particularly in chil- dren, and shall be in a
p.000609: form that can be readily understood by members of the public.’’.
p.000609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000611: 611
p.000611: PUBLIC HEALTH SERVICE ACT
p.000611: Sec. 402
p.000611:
p.000611: (4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed
p.000611: certification to the Secretary that disclosure of such information would substan- tially interfere with the
p.000611: timely enrollment of subjects in the inves- tigation, unless the Secretary, after the receipt of the certification,
p.000611: provides the sponsor with a detailed written determination that such disclosure would not substantially
p.000611: interfere with such enroll- ment.
p.000611: (5) Fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act shall not be used in carrying out this
p.000611: subsection.
p.000611: (j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.—
p.000611: (1) DEFINITIONS; REQUIREMENT.—
p.000611: (A) DEFINITIONS.—In this subsection:
p.000611: (i) APPLICABLE CLINICAL TRIAL.—The term ‘‘appli- cable clinical trial’’ means an applicable device clinical trial
p.000611: or an applicable drug clinical trial.
p.000611: (ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term ‘‘applicable device clinical trial’’ means—
p.000611: (I) a prospective clinical study of health out- comes comparing an intervention with a device subject to
p.000611: section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human
p.000611: subjects (other than a small clinical trial to determine the feasibility of a de- vice, or a clinical
p.000611: trial to test prototype devices where the primary outcome measure relates to feasibility and not to health
p.000611: outcomes); and
p.000611: (II) a pediatric postmarket surveillance as re- quired under section 522 of the Federal Food, Drug, and Cosmetic
p.000611: Act.
p.000611: (iii) APPLICABLE DRUG CLINICAL TRIAL.—
p.000611: (I) IN GENERAL.—The term ‘‘applicable drug clinical trial’’ means a controlled clinical investiga- tion, other
p.000611: than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act
p.000611: or to section 351 of this Act.
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p.000611: (II) CLINICAL INVESTIGATION.—For purposes of subclause (I), the term ‘‘clinical investigation’’ has the meaning
p.000611: given that term in section 312.3 of title 21, Code of Federal Regulations (or any suc- cessor
p.000611: regulation).
p.000611: (III) PHASE I.—For purposes of subclause (I), the term ‘‘phase I’’ has the meaning given that term in
p.000611: section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
p.000611: (iv) CLINICAL TRIAL INFORMATION.—The term ‘‘clinical trial information’’ means, with respect to an
p.000611: applicable clinical trial, those data elements that the responsible party is required to submit under
p.000611: para- graph (2) or under paragraph (3).
p.000611: (v) COMPLETION DATE.—The term ‘‘completion date’’ means, with respect to an applicable clinical trial,
p.000611: the date that the final subject was examined or
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000611: Sec. 402 PUBLIC HEALTH SERVICE ACT 612
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p.000611: received an intervention for the purposes of final col- lection of data for the primary outcome, whether
p.000611: the clinical trial concluded according to the prespecified protocol or was terminated.
p.000611: (vi) DEVICE.—The term ‘‘device’’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.000611: Cosmetic Act.
p.000611: (vii) DRUG.—The term ‘‘drug’’ means a drug as de- fined in section 201(g) of the Federal Food, Drug, and Cosmetic Act
p.000611: or a biological product as defined in sec- tion 351 of this Act.
p.000611: (viii) ONGOING.—The term ‘‘ongoing’’ means, with respect to a clinical trial of a drug or a device and
p.000611: to a date, that—
p.000611: (I) 1 or more patients is enrolled in the clin- ical trial; and
p.000611: (II) the date is before the completion date of the clinical trial.
p.000611: (ix) RESPONSIBLE PARTY.—The term ‘‘responsible party’’, with respect to a clinical trial of a drug or de- vice,
p.000611: means—
p.000611: (I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.000611: successor regulation)); or
p.000611: (II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con-
p.000611: tractor, or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to
p.000611: and control over the data from the clin- ical trial, has the right to publish the results of the trial,
p.000611: and has the ability to meet all of the re- quirements under this subsection for the submis- sion of clinical
p.000611: trial information.
p.000611: (B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for each
p.000611: appli- cable clinical trial shall submit the identity and contact in- formation of such responsible party to the
p.000611: Secretary at the time of submission of clinical trial information under para- graph (2).
p.000611: (2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.000611: (A) IN GENERAL.—
p.000611: (i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.000611: progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.000611: ance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (re-
p.000611: ferred to in this subsection as the ‘‘registry data bank’’). The Director of NIH shall ensure that the
p.000611: reg- istry data bank is made publicly available through the Internet.
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: 613
p.000613: PUBLIC HEALTH SERVICE ACT
p.000613: Sec. 402
p.000613:
p.000613: (ii) CONTENT.—The clinical trial information re- quired to be submitted under this paragraph for an
p.000613: applicable clinical trial shall include—
p.000613: (I) descriptive information, including—
p.000613: (aa) a brief title, intended for the lay pub-
p.000613: lic;
p.000613: (bb) a brief summary, intended for the lay
p.000613: public;
p.000613: (cc) the primary purpose; (dd) the study design;
p.000613: (ee) for an applicable drug clinical trial, the study phase;
p.000613: (ff) study type;
p.000613: (gg) the primary disease or condition being studied, or the focus of the study;
p.000613: (hh) the intervention name and interven- tion type;
p.000613: (ii) the study start date;
p.000613: (jj) the expected completion date;
p.000613: (kk) the target number of subjects; and (ll) outcomes, including primary and sec-
p.000613: ondary outcome measures;
p.000613: (II) recruitment information, including— (aa) eligibility criteria;
p.000613: (bb) gender; (cc) age limits;
p.000613: (dd) whether the trial accepts healthy vol- unteers;
p.000613: (ee) overall recruitment status; (ff) individual site status; and
p.000613: (gg) in the case of an applicable drug clin- ical trial, if the drug is not approved under section 505 of
p.000613: the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.000613: there is ex- panded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act
p.000613: for those who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such
p.000613: access;
p.000613: (III) location and contact information, includ- ing—
p.000613:
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p.000613: and
p.000613: (aa) the name of the sponsor;
p.000613: (bb) the responsible party, by official title;
p.000613: (cc) the facility name and facility contact
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p.000613: January 30, 2020
p.000613: information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.000613: through which such location in- formation may be accessed); and
p.000613: (IV) administrative data (which the Secretary may make publicly available as necessary), includ- ing—
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: Sec. 402 PUBLIC HEALTH SERVICE ACT 614
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p.000613: (aa) the unique protocol identification number;
p.000613: (bb) other protocol identification numbers, if any; and
p.000613: (cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.000613: (iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial infor- mation
p.000613: under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not
p.000613: reduce such clinical trial information.
p.000613: (B) FORMAT AND STRUCTURE.—
p.000613: (i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to key- word
p.000613: searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.000613: (I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.000613: descriptors.
p.000613: (II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.000613: (III) The location of the clinical trial.
p.000613: (IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.000613: (V) The study phase of the clinical trial.
p.000613: (VI) The sponsor of the clinical trial, which may be the National Institutes of Health or an- other
p.000613: Federal agency, a private industry source, or a university or other organization.
p.000613: (VII) The recruitment status of the clinical trial.
p.000613: (VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.000613: (ii) ADDITIONAL SEARCHABLE CATEGORY.—Not later than 18 months after the date of the enactment of the Food and Drug
p.000613: Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries
p.000613: of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary
p.000613: or secondary outcome.
p.000613: (iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.000613: registry data bank by such other elements as the Director deems necessary on an ongoing basis.
p.000613: (iv) FORMAT.—The Director of the NIH shall en- sure that the registry data bank is easily used by the public,
p.000613: and that entries are easily compared.
p.000613: (C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.000613: clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
p.000613: ongoing on the date that is 90 days after, the date of the enactment of the Food and
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000615: 615
p.000615: PUBLIC HEALTH SERVICE ACT
p.000615: Sec. 402
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p.000615: January 30, 2020
p.000615: Drug Administration Amendments Act of 2007, shall sub- mit to the Director of NIH for inclusion in the
p.000615: registry data bank the clinical trial information described in of sub- paragraph (A)(ii) not later than the later of—
p.000615: (i) 90 days after such date of enactment;
p.000615: (ii) 21 days after the first patient is enrolled in such clinical trial; or
p.000615: (iii) in the case of a clinical trial that is not for a serious or life-threatening disease or
p.000615: condition and that is ongoing on such date of enactment, 1 year after such date of enactment.
p.000615: (D) POSTING OF DATA.—
p.000615: (i) APPLICABLE DRUG CLINICAL TRIAL.—The Direc- tor of NIH shall ensure that clinical trial information for
p.000615: an applicable drug clinical trial submitted in ac- cordance with this paragraph is posted in the registry data
p.000615: bank not later than 30 days after such submis- sion.
p.000615: (ii) APPLICABLE DEVICE CLINICAL TRIAL.—The Di- rector of NIH shall ensure that clinical trial informa-
p.000615: tion for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in
p.000615: the registry data bank—
p.000615: (I) not earlier than the date of clearance under section 510(k) of the Federal Food, Drug, and
p.000615: Cosmetic Act, or approval under section 515 or 520(m) of such Act, as applicable, for a device that was
p.000615: not previously cleared or approved, and not later than 30 days after such date, unless the responsible party
p.000615: affirmatively requests that the Director of the National Institutes of Health pub- licly post such clinical
p.000615: trial information for an ap- plicable device clinical trial prior to such date of clearance or approval; or
p.000615: (II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information
p.000615: under paragraph (3)(C) is re- quired to be posted by the Secretary.
p.000615: (iii) OPTION TO MAKE CERTAIN CLINICAL TRIAL IN- FORMATION AVAILABLE EARLIER.—The Director of the National
p.000615: Institutes of Health shall inform responsible parties of the option to request that clinical trial infor- mation
p.000615: for an applicable device clinical trial be pub- licly posted prior to the date of clearance or approval, in
p.000615: accordance with clause (ii)(I).
p.000615: (iv) COMBINATION PRODUCTS.—An applicable clin- ical trial for a product that is a combination of drug,
p.000615: device, or biological product shall be considered—
p.000615: (I) an applicable drug clinical trial, if the Sec- retary determines under section 503(g) of the Fed- eral Food,
p.000615: Drug, and Cosmetic Act that the pri- mary mode of action of such product is that of a drug or
p.000615: biological product; or
p.000615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000615: Sec. 402 PUBLIC HEALTH SERVICE ACT 616
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p.000615: (II) an applicable device clinical trial, if the Secretary determines under such section that the primary
p.000615: mode of action of such product is that of a device.
p.000615: (3) EXPANSION OF REGISTRY DATA BANK TO INCLUDE RE- SULTS OF CLINICAL TRIALS.—
p.000615: (A) LINKING REGISTRY DATA BANK TO EXISTING RE- SULTS.—
p.000615: (i) IN GENERAL.—Beginning not later than 90 days after the date of the enactment of the Food and Drug Administration
p.000615: Amendments Act of 2007, for those clinical trials that form the primary basis of an effi- cacy claim or
p.000615: are conducted after the drug involved is approved or after the device involved is cleared or ap- proved, the
p.000615: Secretary shall ensure that the registry data bank includes links to results information as de- scribed in clause
p.000615: (ii) for such clinical trial—
p.000615: (I) not earlier than 30 days after the date of the approval of the drug involved or clearance or
p.000615: approval of the device involved; or
p.000615: (II) not later than 30 days after the results in- formation described in clause (ii) becomes publicly available.
p.000615: (ii) REQUIRED INFORMATION.—
p.000615: (I) FDA INFORMATION.—The Secretary shall ensure that the registry data bank includes links to the following
p.000615: information:
p.000615: (aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and
p.000615: Drug Administration sum- mary document regarding such applicable clinical trial.
p.000615: (bb) If an applicable drug clinical trial was conducted under section 505A or 505B of the Federal Food, Drug,
p.000615: and Cosmetic Act, a link to the posted Food and Drug Administra- tion assessment of the results of such trial.
p.000615: (cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the
p.000615: applicable clinical trial, if any.
p.000615: (dd) For an applicable drug clinical trial, the Food and Drug Administration action package for
p.000615: approval document required under section 505(l)(2) of the Federal Food, Drug, and Cosmetic Act.
p.000615: (ee) For an applicable device clinical trial, in the case of a premarket application under section 515 of the
p.000615: Federal Food, Drug, and Cosmetic Act, the detailed summary of infor- mation respecting the safety and
p.000615: effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of a report
p.000615: under section 510(k) of such Act, the section 510(k)
p.000615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000617: PUBLIC HEALTH SERVICE ACT
p.000617: Sec. 402
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p.000617: summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal
p.000617: Regulations (or any successor regulation).
p.000617: (II) NIH INFORMATION.—The Secretary shall ensure that the registry data bank includes links to the following
p.000617: information:
p.000617: (aa) Medline citations to any publications focused on the results of an applicable clinical trial.
p.000617: (bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National
p.000617: Library of Medicine database of structured product labels, if available.
p.000617: (iii) RESULTS FOR EXISTING DATA BANK ENTRIES.— The Secretary may include the links described in
p.000617: clause (ii) for data bank entries for clinical trials sub- mitted to the data bank prior to enactment of the Food and
p.000617: Drug Administration Amendments Act of 2007, as available.
p.000617: (B) INCLUSION OF RESULTS.—The Secretary, acting through the Director of NIH, shall—
p.000617: (i) expand the registry data bank to include the results of applicable clinical trials (referred to in
p.000617: this subsection as the ‘‘registry and results data bank’’);
p.000617: (ii) ensure that such results are made publicly available through the Internet;
p.000617: (iii) post publicly a glossary for the lay public ex- plaining technical terms related to the results
p.000617: of clin- ical trials; and
p.000617: (iv) in consultation with experts on risk commu- nication, provide information with the information in-
p.000617: cluded under subparagraph (C) in the registry and re- sults data bank to help ensure that such information does
p.000617: not mislead the patients or the public.
p.000617: (C) BASIC RESULTS.—Not later than 1 year after the date of the enactment of the Food and Drug
p.000617: Administra- tion Amendments Act of 2007, the Secretary shall include in the registry and results data
p.000617: bank for each applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug,
p.000617: and Cosmetic Act or licensed under section 351 of this Act or a device that is cleared under section
p.000617: 510(k) of the Federal Food, Drug, and Cos- metic Act or approved under section 515 or 520(m) of such Act, the
p.000617: following elements:
p.000617: (i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—A table of the demographic and baseline data
p.000617: collected overall and for each arm of the clinical trial to describe the patients who participated in the
p.000617: clinical trial, including the number of patients who dropped out of the clinical trial and the number of
p.000617: patients excluded from the analysis, if any.
p.000617: (ii) PRIMARY AND SECONDARY OUTCOMES.—The pri- mary and secondary outcome measures as submitted
p.000617: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000617: under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome
p.000617: meas- ures for each arm of the clinical trial, including the re- sults of scientifically appropriate tests of the
p.000617: statistical significance of such outcome measures.
p.000617: (iii) POINT OF CONTACT.—A point of contact for sci- entific information about the clinical trial results.
p.000617: (iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to com- ply with
p.000617: applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and
p.000617: the principal investigator (unless the spon- sor is an employer of the principal investigator) that
p.000617: restricts in any manner the ability of the principal in- vestigator, after the completion date of the trial, to
p.000617: discuss the results of the trial at a scientific meeting or any other public or private forum, or to
p.000617: publish in a scientific or academic journal information concerning the results of the trial.
p.000617: (D) EXPANDED REGISTRY AND RESULTS DATA BANK.—
p.000617: (i) EXPANSION BY RULEMAKING.—To provide more complete results information and to enhance patient access to
p.000617: and understanding of the results of clinical trials, not later than 3 years after the date of the en-
p.000617: actment of the Food and Drug Administration Amend- ments Act of 2007, the Secretary shall by regulation expand
p.000617: the registry and results data bank as provided under this subparagraph.
p.000617: (ii) CLINICAL TRIALS.—
p.000617: (I) APPROVED PRODUCTS.—The regulations under this subparagraph shall require the inclu- sion of the
p.000617: results information described in clause
p.000617: (iii) for—
p.000617: (aa) each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food,
p.000617: Drug, and Cosmetic Act or licensed under section 351 of this Act; and
p.000617: (bb) each applicable device clinical trial for a device that is cleared under section 510(k) of
p.000617: the Federal Food, Drug, and Cos- metic Act or approved under section 515 or 520(m) of such Act.
p.000617: (II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.000617: information described in clause
p.000617: (iii) shall be required for—
p.000617: (aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal Food, Drug, and
p.000617: Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure was sought or
p.000617: not); and
p.000617: (bb) an applicable device clinical trial for a device that is not cleared under section
p.000617: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000619: 619
p.000619: PUBLIC HEALTH SERVICE ACT
p.000619: Sec. 402
p.000619:
p.000619: 510(k) of the Federal Food, Drug, and Cos- metic Act and not approved under section 515 or section 520(m) of
p.000619: such Act (whether clear- ance or approval was sought or not).
p.000619: (iii) REQUIRED ELEMENTS.—The regulations under this subparagraph shall require, in addition to the ele- ments
p.000619: described in subparagraph (C), information within each of the following categories:
p.000619: (I) A summary of the clinical trial and its re- sults that is written in non-technical, understand- able
p.000619: language for patients, if the Secretary deter- mines that such types of summary can be included without being
p.000619: misleading or promotional.
p.000619: (II) A summary of the clinical trial and its re- sults that is technical in nature, if the Secretary determines
p.000619: that such types of summary can be in- cluded without being misleading or promotional.
p.000619: (III) The full protocol or such information on the protocol for the trial as may be necessary to help
p.000619: to evaluate the results of the trial.
p.000619: (IV) Such other categories as the Secretary determines appropriate.
p.000619: (iv) RESULTS SUBMISSION.—The results informa- tion described in clause (iii) shall be submitted to the
p.000619: Director of NIH for inclusion in the registry and re- sults data bank as provided by subparagraph (E),
p.000619: ex- cept that the Secretary shall by regulation deter- mine—
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p.000619: registry and results data bank;
p.000619: (II) additional information on clinical trials and results that is written in nontechnical, under- standable
p.000619: language for patients;
p.000619: (III) considering the experience under the pilot quality control project described in para- graph
p.000619: (5)(C), procedures for quality control, in- cluding using representative samples, with respect to completeness
p.000619: and content of clinical trial infor- mation under this subsection, to help ensure that data elements are not
p.000619: false or misleading and are non-promotional;
p.000619: (IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.000619: if so, how such updates should be tracked;
p.000619: (V) a statement to accompany the entry for an applicable clinical trial when the primary and sec- ondary outcome
p.000619: measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.000619: submission of such informa- tion in paragraph (2)(C); and
p.000619: (VI) additions or modifications to the manner of reporting of the data elements established under
p.000619: subparagraph (C).
p.000619: (vi) CONSIDERATION OF WORLD HEALTH ORGANIZA- TION DATA SET.—The Secretary shall consider the sta- tus of the
p.000619: consensus data elements set for reporting clinical trial results of the World Health Organization when issuing
p.000619: the regulations under this subpara- graph.
p.000619: (vii) PUBLIC MEETING.—The Secretary shall hold a public meeting no later than 18 months after the date of the enactment
p.000619: of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties
p.000619: with regard to the regu- lations to be issued under this subparagraph.
p.000619: (E) SUBMISSION OF RESULTS INFORMATION.—
p.000619: (i) IN GENERAL.—Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an
p.000619: ap- plicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion
p.000619: in the registry and results data bank the clinical trial infor- mation described in subparagraph (C) not later
p.000619: than 1 year, or such other period as may be provided by regu- lation under subparagraph (D), after the earlier of—
p.000619: (I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); or
p.000619: (II) the actual date of completion.
p.000619: (ii) CLINICAL TRIALS DESCRIBED.—An applicable clinical trial described in this clause is an
p.000619: applicable clinical trial subject to—
p.000619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000621: 621
p.000621: PUBLIC HEALTH SERVICE ACT
p.000621: Sec. 402
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p.000621: (I) paragraph (2)(C); and (II)(aa) subparagraph (C); or
p.000621: (bb) the regulations issued under subpara- graph (D).
p.000621: (iii) DELAYED SUBMISSION OF RESULTS WITH CER- TIFICATION.—If the responsible party for an applicable clinical
p.000621: trial submits a certification that clause (iv) or
p.000621: (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in
p.000621: the registry and results data bank the clinical trial infor- mation described in subparagraphs (C) and
p.000621: (D) as re- quired under the applicable clause.
p.000621: (iv) SEEKING INITIAL APPROVAL OF A DRUG OR DE- VICE.—With respect to an applicable clinical trial that is
p.000621: completed before the drug is initially approved under section 505 of the Federal Food, Drug, and Cos- metic
p.000621: Act or initially licensed under section 351 of this Act, or the device is initially cleared under section
p.000621: 510(k) or initially approved under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic
p.000621: Act, the responsible party shall submit to the Director of NIH for inclusion in the registry and results
p.000621: data bank the clinical trial information described in sub- paragraphs (C) and (D) not later than 30
p.000621: days after the drug or device is approved under such section 505, licensed under such section 351, cleared under
p.000621: such section 510(k), or approved under such section 515 or 520(m), as applicable.
p.000621: (v) SEEKING APPROVAL OF A NEW USE FOR THE DRUG OR DEVICE.—
p.000621: (I) IN GENERAL.—With respect to an applica- ble clinical trial where the manufacturer of the drug or
p.000621: device is the sponsor of an applicable clin- ical trial, and such manufacturer has filed, or will file within 1 year,
p.000621: an application seeking approval under section 505 of the Federal Food, Drug, and Cosmetic Act, licensing
p.000621: under section 351 of this Act, or clearance under section 510(k), or approval under section 515 or 520(m), of the
p.000621: Federal Food, Drug, and Cosmetic Act for the use studied in such clinical trial (which use is not included in
p.000621: the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for
p.000621: inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C)
p.000621: and (D) on the earlier of the date that is 30 days after the date—
p.000621: (aa) the new use of the drug or device is approved under such section 505, licensed under such
p.000621: section 351, cleared under such section 510(k), or approved under such section 515 or 520(m);
p.000621: (bb) the Secretary issues a letter, such as a complete response letter, not approving the
p.000621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000621: Sec. 402 PUBLIC HEALTH SERVICE ACT 622
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p.000621: January 30, 2020
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p.000621: submission or not clearing the submission, a not approvable letter, or a not substantially equivalent
p.000621: letter for the new use of the drug or device under such section 505, 351, 510(k), 515, or 520(m); or
p.000621: (cc) except as provided in subclause (III), the application or premarket notification under such
p.000621: section 505, 351, 510(k), 515, or 520(m) is withdrawn without resubmission for no less than 210 days.
p.000621: (II) REQUIREMENT THAT EACH CLINICAL TRIAL IN APPLICATION BE TREATED THE SAME.—If a man- ufacturer makes a
p.000621: certification under clause (iii) that this clause applies with respect to a clinical trial, the
p.000621: manufacturer shall make such a certifi- cation with respect to each applicable clinical trial that is required to
p.000621: be submitted in an application or report for licensure, approval, or clearance (under section 351 of
p.000621: this Act or section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, as
p.000621: applicable) of the use stud- ied in the clinical trial.
p.000621: (III) TWO-YEAR LIMITATION.—The responsible party shall submit to the Director of NIH for in- clusion in
p.000621: the registry and results data bank the clinical trial information subject to subclause (I) on the date that
p.000621: is 2 years after the date a certifi- cation under clause (iii) was made to the Director of NIH, if an action
p.000621: referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
p.000621: (vi) EXTENSIONS.—The Director of NIH may pro- vide an extension of the deadline for submission of
p.000621: clinical trial information under clause (i) if the respon- sible party for the trial submits to the Director a writ-
p.000621: ten request that demonstrates good cause for the ex- tension and provides an estimate of the date on which the
p.000621: information will be submitted. The Director of NIH may grant more than one such extension for a clinical
p.000621: trial.
p.000621: (F) NOTICE TO DIRECTOR OF NIH.—The Commissioner of Food and Drugs shall notify the Director of
p.000621: NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of
p.000621: subparagraph (E)(v)(I) with re- spect to an application or a report that includes a certifi- cation
p.000621: required under paragraph (5)(B) of such action not later than 30 days after such action.
p.000621: (G) POSTING OF DATA.—The Director of NIH shall en- sure that the clinical trial information described in
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p.000623: 623
p.000623: PUBLIC HEALTH SERVICE ACT
p.000623: Sec. 402
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p.000623: January 30, 2020
p.000623: (H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL RE- SULTS.—The Secretary may waive any applicable require-
p.000623: ments of this paragraph for an applicable clinical trial, upon a written request from the responsible
p.000623: party, if the Secretary determines that extraordinary circumstances justify the waiver and that
p.000623: providing the waiver is con- sistent with the protection of public health, or in the inter- est of national
p.000623: security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in
p.000623: writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was
p.000623: granted.
p.000623: (I) ADVERSE EVENTS.—
p.000623: (i) REGULATIONS.—Not later than 18 months after the date of the enactment of the Food and Drug Ad-
p.000623: ministration Amendments Act of 2007, the Secretary shall by regulation determine the best method for in-
p.000623: cluding in the registry and results data bank appro- priate results information on serious adverse and
p.000623: fre- quent adverse events for applicable clinical trials de- scribed in subparagraph (C) in a manner and
p.000623: form that is useful and not misleading to patients, physi- cians, and scientists.
p.000623: (ii) DEFAULT.—If the Secretary fails to issue the regulation required by clause (i) by the date that is 24
p.000623: months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007,
p.000623: clause (iii) shall take effect.
p.000623: (iii) ADDITIONAL ELEMENTS.—Upon the application of clause (ii), the Secretary shall include in the reg-
p.000623: istry and results data bank for applicable clinical trials described in subparagraph (C), in addition to
p.000623: the clinical trial information described in subparagraph (C), the following elements:
p.000623: (I) SERIOUS ADVERSE EVENTS.—A table of an- ticipated and unanticipated serious adverse events grouped by organ
p.000623: system, with number and fre- quency of such event in each arm of the clinical trial.
p.000623: (II) FREQUENT ADVERSE EVENTS.—A table of anticipated and unanticipated adverse events that are not included
p.000623: in the table described in sub- clause (I) that exceed a frequency of 5 percent within any arm of the
p.000623: clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.
p.000623: (iv) POSTING OF OTHER INFORMATION.—In carrying out clause (iii), the Secretary shall, in consultation with
p.000623: experts in risk communication, post with the ta- bles information to enhance patient understanding and
p.000623: to ensure such tables do not mislead patients or the lay public.
p.000623: (v) RELATION TO SUBPARAGRAPH (C).—Clinical trial information included in the registry and results data
p.000623: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000623:
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p.000623: Sec. 402 PUBLIC HEALTH SERVICE ACT 624
p.000623: bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank
p.000623: pursuant to subparagraph (C).
p.000623: (4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMA- TION.—
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p.000623: January 30, 2020
p.000623: (A) VOLUNTARY SUBMISSIONS.—A responsible party for a clinical trial that is not an applicable clinical
p.000623: trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete
p.000623: clinical trial infor- mation described in paragraph (2) or paragraph (3) pro- vided the responsible party
p.000623: submits clinical trial informa- tion for each applicable clinical trial that is required to be submitted under
p.000623: section 351 or under section 505, 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act in
p.000623: an application or report for licensure, approval, or clearance of the drug or device for the use
p.000623: studied in the clinical trial.
p.000623: (B) REQUIRED SUBMISSIONS.—
p.000623: (i) IN GENERAL.—Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the
p.000623: Secretary determines for a specific clinical trial de- scribed in clause (ii) that posting in the registry and
p.000623: results data bank of clinical trial information for such clinical trial is necessary to protect the public health—
p.000623: (I) the Secretary may require by notification that such information be submitted to the Sec- retary in
p.000623: accordance with paragraphs (2) and (3) except with regard to timing of submission;
p.000623: (II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such in- formation
p.000623: shall be submitted not later than 30 days after the date specified by the Secretary in the notification;
p.000623: and
p.000623: (III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of
p.000623: the corresponding requirement of such paragraphs.
p.000623: (ii) CLINICAL TRIALS DESCRIBED.—A clinical trial described in this clause is—
p.000623: (I) an applicable clinical trial for a drug that is approved under section 505 of the Federal Food, Drug, and
p.000623: Cosmetic Act or licensed under section
p.000623: 351 of this Act or for a device that is cleared under section 510(k) of the Federal Food, Drug, and
p.000623: Cosmetic Act or approved under section 515 or section 520(m) of such Act, whose completion date is on
p.000623: or after the date 10 years before the date of the enactment of the Food and Drug Ad- ministration
p.000623: Amendments Act of 2007; or
p.000623: (II) an applicable clinical trial that is de- scribed by both by paragraph (2)(C) and para- graph
p.000623: (3)(D)(ii)(II)).
p.000623: (C) UPDATES TO CLINICAL TRIAL DATA BANK.—
p.000623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000625: PUBLIC HEALTH SERVICE ACT
p.000625: Sec. 402
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p.000625: (i) SUBMISSION OF UPDATES.—The responsible party for an applicable clinical trial shall submit to the
p.000625: Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the
p.000625: clinical trial information submitted under paragraph (2). Such updates—
p.000625: (I) shall be provided not less than once every
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p.000625: (III) not later than 30 days after the recruit- ment status of such clinical trial changes, shall in- clude an
p.000625: update of the recruitment status; and
p.000625: (IV) not later than 30 days after the comple- tion date of the clinical trial, shall include notifi-
p.000625: cation to the Director that such clinical trial is complete.
p.000625: (ii) PUBLIC AVAILABILITY OF UPDATES.—The Direc- tor of NIH shall make updates submitted under clause
p.000625: (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual
p.000625: site status, location, and contact information, the Di- rector of NIH shall ensure that updates to
p.000625: elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal
p.000625: of any informa- tion from the original submissions or any preceding updates, and information in such
p.000625: databases is pre- sented in a manner that enables users to readily ac- cess each original element submission
p.000625: and to track the changes made by the updates. The Director of NIH shall provide a link from the table of
p.000625: primary and sec- ondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this
p.000625: clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).
p.000625: (5) COORDINATION AND COMPLIANCE.—
p.000625: (A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FED- ERAL AGENCIES.—
p.000625: (i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—If an applicable clinical trial is funded in whole or in part
p.000625: by a grant from any agency of the Department of Health and Human Services, including the Food and Drug
p.000625: Administration, the National Institutes of Health, or the Agency for Healthcare Research and
p.000625: Quality, any grant or progress report forms required under such grant shall include a certification that the
p.000625: responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).
p.000625: (ii) VERIFICATION BY FEDERAL AGENCIES.—The heads of the agencies referred to in clause (i), as appli- cable,
p.000625: shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the
p.000625: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000625:
p.000625:
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p.000625: Sec. 402 PUBLIC HEALTH SERVICE ACT 626
p.000625:
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p.000625: January 30, 2020
p.000625:
p.000625: responsible party has been submitted under para- graphs (2) and (3) before releasing any
p.000625: remaining funding for a grant or funding for a future grant to such grantee.
p.000625: (iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the head of an agency referred to in clause (i), as applica- ble,
p.000625: verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agen- cy
p.000625: head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to cor- rect
p.000625: such non-compliance and submit the required clinical trial information.
p.000625: (iv) CONSULTATION WITH OTHER FEDERAL AGEN- CIES.—The Secretary shall—
p.000625: (I) consult with other agencies that conduct research involving human subjects in accordance with any
p.000625: section of part 46 of title 45, Code of Federal Regulations (or any successor regula- tions), to
p.000625: determine if any such research is an ap- plicable clinical trial; and
p.000625: (II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and
p.000625: (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under
p.000625: paragraphs (2) and (3).
p.000625: (B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL PRODUCT, AND DEVICE SUBMISSIONS.—At the time of sub-
p.000625: mission of an application under section 505 of the Federal Food, Drug, and Cosmetic Act, section 515 of such Act, sec-
p.000625: tion 520(m) of such Act, or section 351 of this Act, or sub- mission of a report under section 510(k) of such
p.000625: Act, such application or submission shall be accompanied by a cer- tification that all applicable
p.000625: requirements of this sub- section have been met. Where available, such certification shall include the
p.000625: appropriate National Clinical Trial con- trol numbers.
p.000625: (C) QUALITY CONTROL.—
p.000625: (i) PILOT QUALITY CONTROL PROJECT.—Until the effective date of the regulations issued under para- graph
p.000625: (3)(D), the Secretary, acting through the Direc- tor of NIH and the Commissioner of Food and Drugs,
p.000625: shall conduct a pilot project to determine the optimal method of verification to help to ensure that
p.000625: the clin- ical trial information submitted under paragraph (3)(C) is non-promotional and is not
p.000625: false or mis- leading in any particular under subparagraph (D). The Secretary shall use the publicly available
p.000625: information described in paragraph (3)(A) and any other informa- tion available to the Secretary about
p.000625: applicable clinical trials to verify the accuracy of the clinical trial infor- mation submitted under
p.000625: paragraph (3)(C).
p.000625: (ii) NOTICE OF COMPLIANCE.—If the Secretary de- termines that any clinical trial information was not
p.000625: submitted as required under this subsection, or was
p.000625: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000625:
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p.000637: (B) The status of the complaint.
p.000637: (C) The resolution of the complaint to date.
p.000637: (b) FIRST REPORT.—The first report under subsection (a) shall be submitted not later than 1 year after the date
p.000637: of the enactment of the National Institutes of Health Reform Act of 2006.
p.000637: SEC. 403C. ø283a–2¿ ANNUAL REPORTING REGARDING TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES.
p.000637: (a) IN GENERAL.—Each institution receiving an award under this title for the training of graduate students for
p.000637: doctoral degrees shall annually report to the Director of NIH, with respect to grad- uate students supported by the
p.000637: National Institutes of Health at such institution—
p.000637: (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
p.000637: (2) for students described in paragraph (1), the average time between the beginning of graduate study
p.000637: and the receipt of a doctoral degree.
p.000637: (3) 5 PROVISION OF INFORMATION TO APPLICANTS.—Each in- stitution described in subsection (a) shall provide
p.000637: to each stu- dent submitting an application for a program of graduate study at such institution the information
p.000637: described in paragraphs (1) and (2) of such subsection with respect to the program or pro- grams to which such student
p.000637: has applied.
p.000637: DES
p.000637: SEC. 403D. ø283a–3¿ (a) The Director of NIH shall establish a program for the conduct and support of research and
p.000637: training, the dissemination of health information, and other programs with re- spect to the diagnosis and
p.000637: treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred
p.000637: to as ‘‘DES’’).
p.000637: (b) In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private
p.000637: entities representing individ- uals who have been exposed to DES, shall conduct or support pro- grams to educate
p.000637: health professionals and the public on the drug, including the importance of identifying and treating
p.000637: individuals who have been exposed to the drug.
p.000637: (c) After consultation with the Office of Research on Women’s Health, the Director of NIH, acting
p.000637: through the appropriate na- tional research institutes, shall in carrying out subsection (a) con- duct or
p.000637: support one or more longitudinal studies to determine the incidence of the following diseases or
p.000637: disorders in the indicated populations and the relationship of DES to the diseases or dis- orders:
p.000637: (1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant,
p.000637:
p.000637:
p.000637:
p.000637: January 30, 2020
p.000637: 5 So in law. Paragraph (3) probably should be subsection (b).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000637:
p.000637:
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p.000637: Sec. 404A PUBLIC HEALTH SERVICE ACT 638
p.000637:
p.000637: the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of
p.000637: the immune system, including autoimmune disease).
p.000637: (2) In the case of women exposed to DES in utero, the inci- dence of clear cell cancer (including recurrences), the
p.000637: long-term health effects of such cancer, and the effects of treatments for such cancer.
...

p.000639: (c) The Director of NIH shall periodically review, and as appro- priate, make revisions in the plan required under
p.000639: subsection (a). A description of any revision made in the plan shall be included in the first biennial
p.000639: report under section 403 that is submitted after the revision is made.
p.000639: (d) The Director of NIH shall take such actions as may be ap- propriate to convey to scientists and others who use
p.000639: animals in bio- medical or behavioral research or experimentation information re- specting the methods found
p.000639: to be valid and reliable under sub- section (a)(2).
p.000639: (e)(1) The Director of NIH shall establish within the National Institutes of Health a committee to be
p.000639: known as the Interagency Coordinating Committee on the Use of Animals in Research (in this subsection referred to as
p.000639: the ‘‘Committee’’).
p.000639: (2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection
p.000639: (a).
p.000639: (3) The Committee shall be composed of—
p.000639: (A) the Directors of each of the national research institutes (or the designees of such Directors); and
p.000639: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000639:
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p.000639: Sec. 404D PUBLIC HEALTH SERVICE ACT 640
p.000639:
p.000639: (B) representatives of the Environmental Protection Agen- cy, the Food and Drug Administration, the Consumer
p.000639: Product Safety Commission, the National Science Foundation, and such additional agencies as the Director of NIH
p.000639: determines to be ap- propriate, which representatives shall include not less than one veterinarian with
p.000639: expertise in laboratory-animal medicine.
p.000639: REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR
p.000639: SEC. 404D. ø283f¿ With respect to any survey of human sexual behavior proposed to be conducted or supported
p.000639: through the Na- tional Institutes of Health, the survey may not be carried out un- less—
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p.000639: January 30, 2020
p.000639: (1) the proposal has undergone review in accordance with any applicable requirements of sections 491 and 492;
p.000639: and
p.000639: (2) the Secretary, in accordance with section 492A, makes a determination that the information expected
p.000639: to be obtained through the survey will assist—
p.000639: (A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human
p.000639: im- munodeficiency virus, or the incidence of any other infec- tious disease; or
p.000639: (B) in improving reproductive health or other condi- tions of health.
p.000639: SEC. 404E. ø283g¿ MUSCULAR DYSTROPHY; INITIATIVE THROUGH DI- RECTOR OF NATIONAL INSTITUTES OF HEALTH.
...

p.000641: dystrophy.
p.000641: (2) COMPOSITION.—The Coordinating Committee shall con- sist of not more than 18 members to be appointed by the Sec-
p.000641: retary, of which—
p.000641: (A) 2⁄3 of such members shall represent governmental agencies, including the directors or their designees of
p.000641: each of the national research institutes involved in research with respect to muscular dystrophy and
p.000641: representatives of all other Federal departments and agencies whose pro- grams involve health functions or
p.000641: responsibilities relevant to such diseases, including the Centers for Disease Control
p.000641: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000641:
p.000641:
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p.000641: Sec. 404E PUBLIC HEALTH SERVICE ACT 642
p.000641:
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p.000641: January 30, 2020
p.000641:
p.000641: and Prevention, the Health Resources and Services Admin- istration, the Food and Drug Administration, and the
p.000641: Ad- ministration for Community Living and representatives of other governmental agencies that serve
p.000641: children and adults with muscular dystrophy, including the Department of Education and the Social Security
p.000641: Administration; and
p.000641: (B) 1⁄3 of such members shall be public members, in- cluding a broad cross section of persons affected with
p.000641: mus- cular dystrophies including parents or legal guardians, af- fected individuals, researchers, and clinicians.
p.000641: Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an
p.000641: unlimited number of terms if reappointed.
p.000641: (3) CHAIR.—
p.000641: (A) IN GENERAL.—With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the
p.000641: principal advisor to the Secretary, the Assistant Sec- retary for Health, and the Director of NIH, and shall
p.000641: pro- vide advice to the Director of the Centers for Disease Con- trol and Prevention, the Commissioner of Food and
p.000641: Drugs, and to the heads of other relevant agencies. The Coordi- nating Committee shall select the Chair
p.000641: for a term not to exceed 2 years.
p.000641: (B) APPOINTMENT.—The Chair of the Committee shall be appointed by and be directly responsible to the
p.000641: Sec- retary.
p.000641: (4) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PROVISIONS.—The following shall apply with respect to the
p.000641: Co- ordinating Committee:
p.000641: (A) The Coordinating Committee shall receive nec- essary and appropriate administrative support from the
...

p.000649: Sec. 404K
p.000649:
p.000649: CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH ON PRIMATES
p.000649: SEC. 404J. ø283l¿ (a) With respect to activities carried out by the Director of NIH, acting through the
p.000649: Office of the Director of NIH, to support regional centers for research on primates, the Di- rector of
p.000649: NIH may, for each of the fiscal years 1994 through 1996 8, reserve from the amounts appropriated to carry out section
p.000649: 404I up to $2,500,000 for the purpose of making awards of grants and con- tracts to public or nonprofit private
p.000649: entities to construct, renovate, or otherwise improve such regional centers. The reservation of such amounts for any
p.000649: fiscal year is subject to the availability of qualified applicants for such awards.
p.000649: (b) The Director of NIH may not make a grant or enter into a contract under subsection (a) unless the
p.000649: applicant for such assist- ance agrees, with respect to the costs to be incurred by the appli- cant in
p.000649: carrying out the purpose described in such subsection, to make available (directly or through donations
p.000649: from public or pri- vate entities) non-Federal contributions in cash toward such costs in an amount equal to
p.000649: not less than $1 for each $4 of Federal funds provided in such assistance.
p.000649: SEC. 404K. ø283m¿ SANCTUARY SYSTEM FOR SURPLUS CHIMPANZEES.
p.000649: (a) IN GENERAL.—The Secretary shall provide for the establish- ment and operation in accordance with this
p.000649: section of a system to provide for the lifetime care of chimpanzees that have been used, or were bred
p.000649: or purchased for use, in research conducted or sup- ported by the National Institutes of Health, the Food and
p.000649: Drug Ad- ministration, or other agencies of the Federal Government, and with respect to which it has been
p.000649: determined by the Secretary that the chimpanzees are not needed for such research (in this section referred
p.000649: to as ‘‘surplus chimpanzees’’).
p.000649: (b) ADMINISTRATION OF SANCTUARY SYSTEM.—The Secretary shall carry out this section, including the
p.000649: establishment of regula- tions under subsection (d), in consultation with the board of direc- tors of the nonprofit
p.000649: private entity that receives the contract under subsection (e) (relating to the operation of the sanctuary
p.000649: system).
p.000649: (c) ACCEPTANCE OF CHIMPANZEES INTO SYSTEM.—All surplus chimpanzees owned by the Federal Government
p.000649: shall be accepted into the sanctuary system. Subject to standards under subsection (d)(4), any chimpanzee
p.000649: that is not owned by the Federal Govern- ment can be accepted into the system if the owner transfers to the
p.000649: sanctuary system title to the chimpanzee.
p.000649: (d) STANDARDS FOR PERMANENT RETIREMENT OF SURPLUS CHIMPANZEES.—
p.000649: (1) IN GENERAL.—Not later than 180 days after the date of the enactment of this section, the Secretary shall by
p.000649: regulation establish standards for operating the sanctuary system to pro- vide for the permanent retirement of
p.000649: surplus chimpanzees. In establishing the standards, the Secretary shall consider the
p.000649:
p.000649:
p.000649:
p.000649:
p.000649:
p.000649:
p.000649:
p.000649: January 30, 2020
p.000649: 8 The probable intent of the Congress is that the authorization of appropriations be for fiscals year 2000 through
p.000649: 2002. Section 304 of Public Law 106–505 (114 Stat. 2335) provided that sec- tion 481B(a) ‘‘is amended by striking
...

p.000661: (i) appointments to such Board shall be made by the Presi- dent;
p.000661: (ii) the term of office of an appointed member shall be 6 years;
p.000661: (iii) of the members appointed to the Board—
p.000661: (I) not less than 5 members shall be individuals knowledgeable in environmental carcinogenesis
p.000661: (including carcinogenesis involving occupational and dietary factors); and
p.000661:
p.000661:
p.000661:
p.000661:
p.000661:
p.000661:
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p.000661:
p.000661: January 30, 2020
p.000661: (II) not less than one member shall be an individual knowledgeable in pediatric oncology;
p.000661: (iv) the chairman of the Board shall be selected by the President from the appointed members and shall
p.000661: serve as chairman for a term of two years;
p.000661: (v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the
p.000661: Office of Science and Technology Policy, the Director of NIH, the
p.000661: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000661:
p.000661:
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p.000661:
p.000663: 663
p.000663: PUBLIC HEALTH SERVICE ACT
p.000663: Sec. 409
p.000663:
p.000663: Chief Medical Director of the Department of Veterans Affairs, the Director of the National Institute for
p.000663: Occupational Safety and Health, the Director of the National Institute of Environ- mental Health Sciences,
p.000663: the Secretary of Labor, the Commis- sioner of the Food and Drug Administration, the Administrator of the
p.000663: Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary
p.000663: of Defense for Health Affairs, and the Director of the Office of Science of the Department of Energy (or the designees
p.000663: of such officers); and
p.000663: (vi) the Board shall meet at least four times each fiscal year.
p.000663: (B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that
p.000663: the advisory council shall meet at least four times each fiscal year. 10
p.000663: CERTAIN USES OF FUNDS
p.000663: SEC. 408. ø284c¿ (a)(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal
p.000663: year for administra- tive expenses of the National Institutes of Health may not exceed an amount which is
p.000663: 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
p.000663: (2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing
p.000663: Research, 11 the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G.
p.000663: Magnuson Clinical Center, and the Office of Medical Applications of Research.
p.000663: (3) For purposes of paragraph (1), the term ‘‘administrative ex- penses’’ means expenses incurred for the support
p.000663: of activities rel- evant to the award of grants, contracts, and cooperative agree- ments and expenses
p.000663: incurred for general administration of the sci- entific programs and activities of the National Institutes of Health.
p.000663: (b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of
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p.000667:
p.000667:
p.000667:
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p.000667: Sec. 409D PUBLIC HEALTH SERVICE ACT 668
p.000667:
p.000667: on the existing and planned programs and activities of the Na- tional Institutes of Health with respect
p.000667: to autism spectrum dis- order and through which the Director can receive comments from the public regarding
p.000667: such programs and activities.
p.000667: PEDIATRIC RESEARCH INITIATIVE
p.000667: SEC. 409D. ø284h¿ (a) ESTABLISHMENT.—The Secretary shall establish within the Office of the Director of
p.000667: NIH a Pediatric Re- search Initiative (referred to in this section as the ‘‘Initiative’’) to conduct and
p.000667: support research that is directly related to diseases, disorders, and other conditions in children. The
p.000667: Initiative shall be headed by the Director of NIH.
p.000667: (b) PURPOSE.—The purpose of the Initiative is to provide funds to enable the Director of NIH—
p.000667: (1) to increase support for pediatric biomedical research within the National Institutes of Health to realize
p.000667: the expand- ing opportunities for advancement in scientific investigations and care for children;
p.000667: (2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in
p.000667: the areas that the Director deems most promising; and
p.000667: (3) in coordination with the Food and Drug Administra- tion, to increase the development of adequate pediatric
p.000667: clinical trials and pediatric use information to promote the safer and more effective use of prescription
p.000667: drugs in the pediatric popu- lation.
p.000667: (c) DUTIES.—In carrying out subsection (b), the Director of NIH shall—
p.000667: (1) consult with the Director of the Eunice Kennedy Shriv-
p.000667: er National Institute of Child Health and Human Development and the other national research institutes, in considering
p.000667: their requests for new or expanded pediatric research efforts, and consult with the Administrator of the
p.000667: Health Resources and Services Administration and other advisors as the Director de- termines to be appropriate;
p.000667: (2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of
p.000667: grants, and between basic and clinical research so long as the assistance is directly related to the
p.000667: illnesses and conditions of children; and
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p.000667: (3) be responsible for the oversight of any newly appro- priated Initiative funds and annually report to
p.000667: Congress and the public on the extent of the total funds obligated to conduct or support pediatric research
p.000667: across the National Institutes of Health, including the specific support and research awards al- located through
p.000667: the Initiative.
p.000667: (d) NATIONAL PEDIATRIC RESEARCH NETWORK.—
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p.000669: other mechanisms, to public or private nonprofit entities for pro- viding support for pediatric research
p.000669: consortia, including with respect to—
p.000669: (i) basic, clinical, behavioral, or translational re- search to meet unmet needs for pediatric research;
p.000669: and
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p.000669: (ii) training researchers in pediatric research tech- niques in order to address unmet pediatric research needs.
p.000669: (B) RESEARCH.—The Director of NIH shall, as appro- priate, ensure that—
p.000669: (i) each consortium receiving an award under sub- paragraph (A) conducts or supports at least one cat- egory of
p.000669: research described in subparagraph (A)(i) and collectively such consortia conduct or support such cat- egories of
p.000669: research; and
p.000669: (ii) one or more such consortia provide training de- scribed in subparagraph (A)(ii).
p.000669: (C) ORGANIZATION OF CONSORTIUM.—Each consortium receiving an award under subparagraph (A) shall—
p.000669: (i) be formed from a collaboration of cooperating institutions;
p.000669: (ii) be coordinated by a lead institution or institu- tions;
p.000669: (iii) agree to disseminate scientific findings, in- cluding from clinical trials, rapidly and efficiently,
p.000669: as appropriate, to—
p.000669: (I) other consortia;
p.000669: (II) the National Institutes of Health;
p.000669: (III) the Food and Drug Administration;
p.000669: (IV) and other relevant agencies; and
p.000669: (iv) meet such requirements as may be prescribed by the Director of NIH.
p.000669: (D) SUPPLEMENT, NOT SUPPLANT.—Any support re- ceived by a consortium under subparagraph (A) shall be
p.000669: used to supplement, and not supplant, other public or pri- vate support for activities authorized to be
p.000669: supported under this paragraph.
p.000669: (E) DURATION OF SUPPORT.—Support of a consortium under subparagraph (A) shall be for a period of not to ex- ceed
p.000669: 5 years. Such period may be extended at the discre- tion of the Director of NIH.
p.000669: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000669:
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p.000669:
p.000669: Sec. 409E PUBLIC HEALTH SERVICE ACT 670
p.000669:
p.000669: (3) COORDINATION OF CONSORTIA ACTIVITIES.—The Director of NIH shall, as appropriate—
p.000669: (A) provide for the coordination of activities (including the exchange of information and regular communication)
p.000669: among the consortia established pursuant to paragraph (2); and
p.000669: (B) require the periodic preparation and submission to the Director of reports on the activities of each such
p.000669: con- sortium.
p.000669: (4) ASSISTANCE WITH REGISTRIES.—Each consortium receiv- ing an award under paragraph (2)(A) may provide
p.000669: assistance, as appropriate, to the Centers for Disease Control and Preven- tion for activities related to patient
...

p.000669: (referred to in this section as the ‘‘Coordinating Committee’’) coordinates ac- tivities across the
p.000669: National Institutes and with other Federal health programs and activities relating to such diseases.
p.000669: (2) COMPOSITION.—The Coordinating Committee shall be composed of the directors or their designees of each of the
p.000669: na-
p.000669: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000671: PUBLIC HEALTH SERVICE ACT
p.000671: Sec. 409E
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p.000671: January 30, 2020
p.000671: tional research institutes involved in research with respect to autoimmune diseases and representatives of
p.000671: all other Federal departments and agencies whose programs involve health func- tions or responsibilities relevant to
p.000671: such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.
p.000671: (3) CHAIR.—
p.000671: (A) IN GENERAL.—With respect to autoimmune dis- eases, the Chair of the Committee shall serve as the prin- cipal
p.000671: advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice
p.000671: to the Director of the Centers for Disease Control and Pre- vention, the Commissioner of Food and Drugs, and
p.000671: other relevant agencies.
p.000671: (B) DIRECTOR OF NIH.—The Chair of the Committee shall be directly responsible to the Director of NIH.
p.000671: (c) PLAN FOR NIH ACTIVITIES.—
p.000671: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Coordinating
p.000671: Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases
p.000671: through the national research institutes and shall periodically review and revise the plan. The plan shall—
p.000671: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000671: psychosocial, and rehabilitative issues, including studies of the dispropor- tionate impact of such diseases on
p.000671: women;
p.000671: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000671: regarding such diseases; and
p.000671: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000671: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to autoimmune diseases,
p.000671: provide for the following as appropriate:
p.000671: (A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
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p.000673:
p.000673: (B) Principles of clinical pharmacology and pharmaco- kinetics.
p.000673: (C) Clinical epidemiology.
p.000673: (D) Computer data management and medical informatics.
p.000673: (E) Ethical and regulatory issues.
p.000673: (F) Biomedical writing.
p.000673: (2) APPLICATIONS.—An application for a grant under this subsection shall be submitted by an individual
p.000673: institution or a consortium of institutions at such time as the Director may re- quire. An institution may submit only
p.000673: one such application.
p.000673: (3) LIMITATIONS.—Grants under this subsection shall be for terms of up to 5 years and may be renewable.
p.000673: SEC. 409I. ø284m¿ PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 14
p.000673: (a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.—
p.000673: (1) IN GENERAL.—Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of
p.000673: 2007, the Secretary, acting through the Director of the Na- tional Institutes of Health and in
p.000673: consultation with the Com- missioner of Food and Drugs and experts in pediatric research, shall develop and
p.000673: publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or
p.000673: indica- tions that require study. The list shall be revised every three years.
p.000673: (2) CONSIDERATION OF AVAILABLE INFORMATION.—In devel- oping and prioritizing the list under paragraph (1),
p.000673: the Sec- retary—
p.000673: (A) shall consider—
p.000673: (i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic deter- minants of
p.000673: drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
p.000673: (ii) particular pediatric diseases, disorders or con- ditions where more complete knowledge and testing of
p.000673: therapeutics, including drugs and biologics, and identi- fication of biomarkers for such diseases, disorders, or
p.000673: conditions, may be beneficial in pediatric populations; and
p.000673: (iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including
p.000673: research networks and trained pediatric investigators; and
p.000673: (B) may consider the availability of qualified counter- measures (as defined in section 319F–1), security
p.000673: counter- measures (as defined in section 319F–2), and qualified pandemic or epidemic products (as
p.000673: defined in section 319F–3) to address the needs of pediatric populations, in consultation with the
p.000673: Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.
p.000673:
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p.000673: January 30, 2020
p.000673: 14 Section 16 of Public Law 107–109 (115 Stat. 1421) requires the Comptroller General of the United States, in
p.000673: consultation with the Secretary of Health and Human Services, to submit to Congress a report that
p.000673: relates to section 409I and to section 505A of the Federal Food, Drug, and Cosmetic Act. The report is
p.000673: required to be submitted not later than October 1, 2006.
p.000673: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000675: PUBLIC HEALTH SERVICE ACT
p.000675: Sec. 409I
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p.000675: (b) PEDIATRIC STUDIES AND RESEARCH.—The Secretary, acting through the National Institutes of Health, shall award
p.000675: funds to en- tities that have the expertise to conduct pediatric clinical trials or other research
p.000675: (including qualified universities, hospitals, labora- tories, contract research organizations, practice
p.000675: groups, federally funded programs such as pediatric pharmacology research units, other public or private
p.000675: institutions, or individuals) to enable the en- tities to conduct the drug studies or other research on the
p.000675: issues described in paragraphs (1) and (2)(A) of subsection (a). The Sec- retary may use contracts,
p.000675: grants, or other appropriate funding mechanisms to award funds under this subsection.
p.000675: (c) PROCESS FOR PROPOSED PEDIATRIC STUDY REQUESTS AND
p.000675: LABELING CHANGES.—
p.000675: (1) SUBMISSION OF PROPOSED PEDIATRIC STUDY REQUEST.— The Director of the National Institutes of Health
p.000675: shall, as ap- propriate, submit proposed pediatric study requests for consid- eration by the Commissioner of
p.000675: Food and Drugs for pediatric studies of a specific pediatric indication identified under sub- section (a).
p.000675: Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under
p.000675: subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act, or section 351(m) of this Act,
p.000675: including with respect to the information provided on the pediatric studies to be conducted pursuant to the request.
p.000675: The Director of the Na- tional Institutes of Health may submit a proposed pediatric study request for a drug
p.000675: for which—
p.000675: (A)(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or sec-
p.000675: tion 351(k) of this Act; or
p.000675: (ii) there is a submitted application that could be ap- proved under the criteria of such section; and
p.000675: (B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and every
p.000675: three-year and five-year period referred to in sub- section (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv),
p.000675: (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic
p.000675: Act, or applicable twelve-year period referred to in section 351(k)(7) of this Act, and any seven-year period
p.000675: referred to in section 527 of the Federal Food, Drug, and Cosmetic Act has ended for at least one form of the
p.000675: drug; and
p.000675: (C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the
p.000675: pediatric population.
p.000675: (2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS.—The Commissioner of Food and Drugs, in
p.000675: consultation with the Director of the National Institutes of Health, may issue a written request based on
p.000675: the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which
p.000675: shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug iden- tified under
p.000675: subsection (a) to all holders of an approved appli- cation for the drug. Such a written request shall be made
p.000675: in a manner equivalent to the manner in which a written request
p.000675: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000675: Sec. 409I PUBLIC HEALTH SERVICE ACT 676
p.000675:
p.000675: is made under subsection (b) or (c) of section 505A of the Fed- eral Food, Drug, and Cosmetic Act or section
p.000675: 351(m) of this Act, including with respect to information provided on the pe- diatric studies to be
p.000675: conducted pursuant to the request and using appropriate formulations for each age group for which the
p.000675: study is requested.
p.000675: (3) REQUESTS FOR PROPOSALS.—If the Commissioner of Food and Drugs does not receive a response to
p.000675: a written re- quest issued under paragraph (2) not later than 30 days after the date on which a
p.000675: request was issued, the Secretary, acting through the Director of the National Institutes of Health and
p.000675: in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to
p.000675: conduct the pediatric studies described in the written request in accordance with subsection (b).
p.000675: (4) DISQUALIFICATION.—A holder that receives a first right of refusal shall not be entitled to respond to a request
p.000675: for pro- posals under paragraph (3).
p.000675: (5) CONTRACTS, GRANTS, OR OTHER FUNDING MECHA- NISMS.—A contract, grant, or other funding may be
p.000675: awarded under this section only if a proposal is submitted to the Sec- retary in such form and manner,
p.000675: and containing such agree- ments, assurances, and information as the Secretary deter- mines to be necessary
p.000675: to carry out this section.
p.000675: (6) REPORTING OF STUDIES.—
p.000675: (A) IN GENERAL.—On completion of a pediatric study in accordance with an award under this section, a
p.000675: report concerning the study shall be submitted to the Director of the National Institutes of Health and the
p.000675: Commissioner of Food and Drugs. The report shall include all data gen- erated in connection with the
p.000675: study, including a written request if issued.
p.000675: (B) AVAILABILITY OF REPORTS.—
p.000675: (i) IN GENERAL.—Each report submitted under subparagraph (A) shall be considered to be in the pub- lic domain
p.000675: (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after
p.000675: submission of such report, shall be—
p.000675: (I) posted on the internet website of the Na- tional Institutes of Health in a manner that is ac- cessible and
p.000675: consistent with all applicable Federal laws and regulations, including such laws and regulations for the
p.000675: protection of—
p.000675: (aa) human research participants, includ- ing with respect to privacy, security, informed consent, and
p.000675: protected health information; and
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p.000675: (bb) proprietary interests, confidential commercial information, and intellectual prop- erty rights; and
p.000675: (II) assigned a docket number by the Commis- sioner of Food and Drugs and made available for the submission of
p.000675: public comments.
p.000675: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000677: PUBLIC HEALTH SERVICE ACT
p.000677: Sec. 409I
p.000677:
p.000677: (ii) SUBMISSION OF COMMENTS.—An interested per- son may submit written comments concerning such pe- diatric
p.000677: studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket
p.000677: file with respect to each of the drugs.
p.000677: (C) ACTION BY COMMISSIONER.—The Commissioner of Food and Drugs shall take action in a timely and appro-
p.000677: priate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of
p.000677: the report under subparagraph (A), in accordance with paragraph (7).
p.000677: (7) REQUESTS FOR LABELING CHANGE.—Within the 180-day period after the date on which a report is submitted
p.000677: under paragraph (6)(A), the Commissioner of Food and Drugs shall—
p.000677: (A) review the report and such other data as are avail- able concerning the safe and effective use in the
p.000677: pediatric population of the drug studied;
p.000677: (B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the
p.000677: Commissioner of Food and Drugs determines to be appro- priate and requests the holders to make; and
p.000677: (C)(i) include in the public docket file a reference to the location of the report on the internet
p.000677: website of the National Institutes of Health and a copy of any requested labeling changes; and
p.000677: (ii) publish through a posting on the Web site of the Food and Drug Administration a summary of the
p.000677: report and a copy of any requested labeling changes.
p.000677: (8) DISPUTE RESOLUTION.—
p.000677: (A) REFERRAL TO PEDIATRIC ADVISORY COMMITTEE.—If, not later than the end of the 180-day period specified
p.000677: in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling
p.000677: change re- quested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and
p.000677: Drugs shall refer the request to the Pediatric Advisory Committee.
p.000677: (B) ACTION BY THE PEDIATRIC ADVISORY COMMITTEE.— Not later than 90 days after receiving a referral under
p.000677: subparagraph (A), the Pediatric Advisory Committee shall—
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p.000677: (i) review the available information on the safe and effective use of the drug in the pediatric popu-
p.000677: lation, including study reports submitted under this section; and
p.000677: (ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
p.000677: (9) FDA DETERMINATION.—Not later than 30 days after re- ceiving a recommendation from the Pediatric Advisory
p.000677: Com- mittee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs
p.000677: shall consider the rec- ommendation and, if appropriate, make a request to the hold- ers of approved
p.000677: applications for the drug to make any labeling
p.000677: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000677:
p.000677: change that the Commissioner of Food and Drugs determines to be appropriate.
p.000677: (10) FAILURE TO AGREE.—If a holder of an approved appli- cation for a drug, within 30 days after receiving a
p.000677: request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the
p.000677: Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and
p.000677: Cosmetic Act.
p.000677: (11) NO EFFECT ON AUTHORITY.—Nothing in this subsection limits the authority of the United States to bring an
p.000677: enforce- ment action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate
p.000677: pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement
p.000677: action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the
p.000677: other course of action.
p.000677: (d) AUTHORIZATION OF APPROPRIATIONS.—
p.000677: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section, $25,000,000 for each
p.000677: of fiscal years 2018 through 2022.
p.000677: (2) AVAILABILITY.—Any amount appropriated under para- graph (1) shall remain available to carry out this section
p.000677: until expended.
p.000677: SEC. 409J. ø284q¿ PAIN RESEARCH.
p.000677: (a) RESEARCH INITIATIVES.—
p.000677: (1) IN GENERAL.—The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an
p.000677: aggres- sive program of basic and clinical research on the causes of and potential treatments for pain.
p.000677: (2) ANNUAL RECOMMENDATIONS.—Not less than annually, the Pain Consortium, in consultation with the Division of
p.000677: Pro- gram Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of
p.000677: NIH recommendations on appropriate pain research initiatives that could be under- taken with funds reserved
p.000677: under section 402A(c)(1) for the Common Fund or otherwise available for such initiatives.
p.000677: (3) DEFINITION.—In this subsection, the term ‘‘Pain Con- sortium’’ means the Pain Consortium of the National
p.000677: Institutes of Health or a similar trans-National Institutes of Health co- ordinating entity designated by
p.000677: the Secretary for purposes of this subsection.
p.000677: (b) INTERAGENCY PAIN RESEARCH COORDINATING COMMITTEE.—
...

p.000679: research and treatment.
p.000679: (ii) 12 additional voting members appointed under subparagraph (B).
p.000679: (B) ADDITIONAL MEMBERS.—The Committee shall in- clude additional voting members appointed by the Sec-
p.000679: retary as follows:
p.000679: (i) 6 non-Federal members shall be appointed from among scientists, physicians, and other health profes- sionals.
p.000679: (ii) 6 members shall be appointed from members of the general public, who are representatives of lead- ing
p.000679: research, advocacy, and service organizations for individuals with pain-related conditions.
p.000679: (C) NONVOTING MEMBERS.—The Committee shall in- clude such nonvoting members as the Secretary deter- mines
p.000679: to be appropriate.
p.000679: (3) CHAIRPERSON.—The voting members of the Committee shall select a chairperson from among such members.
p.000679: The se- lection of a chairperson shall be subject to the approval of the Director of NIH.
p.000679: (4) MEETINGS.—The Committee shall meet at the call of the chairperson of the Committee or upon the
p.000679: request of the Director of NIH, but in no case less often than once each year.
p.000679: (5) DUTIES.—The Committee shall—
p.000679: (A) develop a summary of advances in pain care re- search supported or conducted by the Federal agencies rel-
p.000679: evant to the diagnosis, prevention, treatment, and man- agement of pain and diseases and disorders
p.000679: associated with pain, including information on best practices for the utilization of non-pharmacologic
p.000679: treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and
p.000679: Drug Administration;
p.000679: (B) identify critical gaps in basic and clinical research on—
p.000679:
p.000679:
p.000679:
p.000679:
p.000679:
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p.000679:
p.000679: January 30, 2020
p.000679: (i) the symptoms and causes of pain, including the
p.000679: identification of relevant biomarkers and screening models and the epidemiology of acute and chronic
p.000679: pain;
p.000679: (ii) the diagnosis, prevention, treatment, and man- agement of acute and chronic pain, including with re- spect
p.000679: to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared
p.000679: by the Food and Drug Administration; and
p.000679: (iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and
p.000679: chronic pain; and
p.000679: (C) make recommendations to the Director of NIH—
p.000679: (i) to ensure that the activities of the National In- stitutes of Health and other Federal agencies are free of
p.000679: unnecessary duplication of effort;
p.000679: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000679:
p.000679:
p.000679:
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p.000679:
p.000679: Sec. 410 PUBLIC HEALTH SERVICE ACT 680
p.000679:
p.000679: (ii) on how best to disseminate information on pain care and epidemiological data related to acute and
p.000679: chronic pain; and
p.000679: (iii) on how to expand partnerships between public entities and private entities to expand collaborative,
p.000679: cross-cutting research.
p.000679: (6) REPORT.—The Secretary shall ensure that rec- ommendations and actions taken by the Director
p.000679: with respect to the topics discussed at the meetings described in paragraph
p.000679: (4) are included in appropriate reports to Congress.
p.000679: (7) REVIEW.—The Secretary shall review the necessity of the Committee at least once every 2 years.
p.000679: PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000679: Subpart 1—National Cancer Institute
p.000679: PURPOSE OF INSTITUTE
...

p.000705: information and education on health-related behaviors that can improve such important risk factors as
p.000705: smoking, obesity, high blood cholesterol, and lack of exercise.
p.000705: COORDINATION OF FEDERAL ASTHMA ACTIVITIES
p.000705: SEC. 424B 22 ø285b–7b¿ (a) IN GENERAL.—The Director of In- stitute shall, through the National Asthma
p.000705: Education Prevention Program Coordinating Committee—
p.000705: (1) identify all Federal programs that carry out asthma-re- lated activities; and
p.000705: (2) develop, in consultation with appropriate Federal agen- cies and professional and voluntary health
p.000705: organizations, a Federal plan for responding to asthma.
p.000705: (b) REPRESENTATION OF THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT.—A representative of the
p.000705: Department of Housing and Urban Development shall be included on the National Asthma Education Prevention Program
p.000705: Coordinating Committee for the purpose of performing the tasks described in subsection (a). 23
p.000705: SEC. 424C. ø285b–7c¿ TUBERCULOSIS.
p.000705: (a) IN GENERAL.—The Director of the National Institutes of Health may expand, intensify, and coordinate
p.000705: research and devel- opment and related activities of the Institutes with respect to tu- berculosis
p.000705: including activities toward the goal of eliminating such disease.
p.000705: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000705: (1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis;
p.000705: (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and
p.000705: (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods
p.000705: to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.
p.000705: SEC. 425. ø285b–8¿ CONGENITAL HEART DISEASE.
p.000705: (a) IN GENERAL.—The Director of the Institute may expand, in- tensify, and coordinate research and related activities
p.000705: of the Insti- tute with respect to congenital heart disease, which may include congenital heart disease
p.000705: research with respect to—
p.000705: (1) causation of congenital heart disease, including genetic causes;
p.000705: (2) long-term outcomes in individuals with congenital heart disease, including infants, children,
p.000705: teenagers, adults, and elderly individuals;
p.000705: (3) diagnosis, treatment, and prevention;
p.000705:
p.000705:
p.000705:
p.000705:
p.000705: January 30, 2020
p.000705: 22 So in law. The section designation lacks a period. See section 521 of Public Law 106–310 (114 Stat.
p.000705: 1116).
p.000705: 23 Section 425 was repealed by section 103(b)(20) of Public Law 109–482 (120 Stat. 3688).
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
p.000705:
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p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
p.000745: (6) conduct an intramural program of biomedical, behav- ioral, epidemiological, and social research,
p.000745: including research into the most effective means of treatment and service deliv- ery, and including
p.000745: research involving human subjects, which is—
p.000745: (A) located in an institution capable of providing all necessary medical care for such human subjects,
p.000745: including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and
p.000745: intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is
p.000745: determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
p.000745:
p.000745:
p.000745:
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p.000745:
p.000745: January 30, 2020
p.000745: (B) associated with an accredited medical or research training institution;
p.000745: (7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health
p.000745: Service, persons not otherwise eligible for such treatment;
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p.000747: alco- holism and other alcohol problems;
p.000747: (E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol
p.000747: problems for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other
p.000747: specialized grad- uate students; and
p.000747: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000747: social service fields as the Secretary may require. 40
p.000747: (2) the application contains a detailed five-year plan for re- search relating to alcoholism and other alcohol
p.000747: problems.
p.000747: (b) The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to
p.000747: Centers which have been designated under this section. No funds provided under a grant under this subsection may be
p.000747: used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For
p.000747: the purposes of the preceding sentence, the term ‘‘con- struction’’ has the meaning given that term by section
p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000747: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of drug
p.000747: abuse. In carrying out the program, the Director of the Institute shall give special consider- ation to
p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
p.000747:
p.000747:
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p.000747:
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p.000747:
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p.000747: January 30, 2020
p.000747: 40 So in law. See section 16(a)(5) of Public Law 96–180 (93 Stat. 1305). The period probably should be
p.000747: ‘‘; and’’. (Section 464J formerly was section 504 of another law. The amendment made by Public Law 96–180 was directed
p.000747: to section 504 of that other law, which was Public Law 91– 616.)
p.000747: 41 So in law. See section 2(a) of Public Law 102–352 (106 Stat. 938). Section 701(1) does not provide
p.000747: a definition for the term ‘‘construction’’, but former section 701(1) did provide such a definition.
p.000747: Public Law 102–408 amended title VII generally; definitions for the title are now pro- vided in section 799, and that
p.000747: section does not define the term ‘‘construction’’.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000747:
p.000747:
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p.000749: 749
p.000749: PUBLIC HEALTH SERVICE ACT
p.000749: Sec. 464N
p.000749:
p.000749: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Substance Abuse and Mental Health
p.000749: Services Ad- ministration in focusing the services research activities of the Insti- tute and in disseminating the
p.000749: results of such research to health professionals and the general public.
p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
p.000749: SEC. 464M. ø285o–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000749: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000749: concerning the prevention of drug abuse. The Asso- ciate Director shall be appointed by the Director of the
p.000749: Institute from individuals who because of their professional training or ex- pertise are experts in drug abuse
p.000749: and the prevention of such abuse.
p.000749: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000749: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000749: and resources allocated to those activities.
p.000749:
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p.000749: January 30, 2020
p.000749:
p.000749: DRUG ABUSE RESEARCH CENTERS
p.000749: SEC. 464N. ø285o–2¿ (a) AUTHORITY.—The Director of the In- stitute may designate National Drug Abuse
p.000749: Research Centers for the purpose of interdisciplinary research relating to drug abuse and other biomedical,
p.000749: behavioral, and social issues related to drug abuse. No entity may be designated as a Center unless an applica-
p.000749: tion therefore has been submitted to, and approved by, the Sec- retary. Such an application shall be
p.000749: submitted in such manner and contain such information as the Secretary may reasonably require. The Secretary may not
p.000749: approve such an application unless—
p.000749: (1) the application contains or is supported by reasonable assurances that—
p.000749: (A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social,
p.000749: and re- lated disciplines, long-term research on drug abuse and to provide coordination of such research among
p.000749: such dis- ciplines;
p.000749: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000749: facili- ties) to carry out the research plan contained in the appli- cation;
p.000749: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000749: drug abuse;
p.000749: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000749: drug abuse;
p.000749: (E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse
p.000749: for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other specialized
p.000749: grad- uate students; and
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000749:
p.000749:
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p.000749: Sec. 464N PUBLIC HEALTH SERVICE ACT 750
p.000749:
p.000749: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000749: social service fields as the Secretary may require. 42
p.000749: (2) the application contains a detailed five-year plan for re- search relating to drug abuse.
p.000749: (b) GRANTS.—The Director of the Institute shall, under such conditions as the Secretary may reasonably
p.000749: require, make annual grants to Centers which have been designated under this section. No funds provided
p.000749: under a grant under this subsection may be used for the purchase of any land or the purchase,
p.000749: construction, preservation, or repair of any building. For the purposes of the pre- ceding sentence, the term
p.000749: ‘‘construction’’ has the meaning given that term by section 701(1). 43
p.000749: (c) DRUG ABUSE AND ADDITION 44 RESEARCH.—
p.000749: (1) GRANTS OR COOPERATIVE AGREEMENTS.—The Director of the Institute may make grants or enter into cooperative agree-
p.000749: ments to expand the current and ongoing interdisciplinary re- search and clinical trials with treatment
p.000749: centers of the Na- tional Drug Abuse Treatment Clinical Trials Network relating to drug abuse and addiction,
p.000749: including related biomedical, be- havioral, and social issues.
p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
p.000749: for drug abuse and addiction may be used for research and clinical trials relating to—
p.000749: (A) the effects of drug abuse on the human body, in- cluding the brain;
p.000749: (B) the addictive nature of drugs and how such effects differ with respect to different individuals;
p.000749: (C) the connection between drug abuse and mental health;
p.000749: (D) the identification and evaluation of the most effec- tive methods of prevention of drug abuse and addiction;
p.000749: (E) the identification and development of the most ef- fective methods of treatment of drug addiction,
p.000749: including pharmacological treatments;
p.000749: (F) risk factors for drug abuse;
p.000749: (G) effects of drug abuse and addiction on pregnant women and their fetuses; and
p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
p.000749:
p.000749:
p.000749:
p.000749:
p.000749:
p.000749:
p.000749: January 30, 2020
p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000749:
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p.000751: 751
p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000751: with respect to AIDS research related to—
p.000751: (1) primary prevention of the spread of HIV, including transmission via drug abuse;
p.000751: (2) drug abuse services research; and
p.000751: (3) other matters determined appropriate by the Director.
p.000751:
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p.000751: January 30, 2020
p.000751:
p.000751: MEDICATION DEVELOPMENT PROGRAM
p.000751: SEC. 464P. ø285o–4¿ (a) ESTABLISHMENT.—There is established in the Institute a Medication Development Program
p.000751: through which the Director of such Institute shall—
p.000751: (1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate
p.000751: the ap- proval process of drug abuse treatments;
p.000751: (2) encourage and promote (through grants, contracts, international collaboration, or otherwise)
p.000751: expanded research programs, investigations, experiments, community trials, and studies, into the development
p.000751: and use of medications to treat drug addiction;
p.000751: (3) establish or provide for the establishment of research facilities;
p.000751: (4) report on the activities of other relevant agencies relat- ing to the development and use of
p.000751: pharmacotherapeutic treat- ments for drug addiction;
p.000751: (5) collect, analyze, and disseminate data useful in the de- velopment and use of pharmacotherapeutic treatments for
p.000751: drug addiction and collect, catalog, analyze, and disseminate through international channels, the
p.000751: results of such research;
p.000751: ctly or through grants, contracts, or cooperative agree- ments, support training in the fundamental
p.000751: sciences and clin- ical disciplines related to the pharmacotherapeutic treatment of drug abuse, including
p.000751: the use of training stipends, fellow- ships, and awards where appropriate; and
p.000751: (7) coordinate the activities conducted under this section with related activities conducted within the National
p.000751: Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate
p.000751: institutes and shall con- sult with the Directors of such Institutes.
p.000751: (b) DUTIES.—In carrying out the activities described in sub- section (a), the Director of the Institute—
p.000751: (1) shall collect and disseminate through publications and other appropriate means, information pertaining
p.000751: to the re- search and other activities under this section;
p.000751: (2) shall make grants to or enter into contracts and cooper- ative agreements with individuals and public and private
p.000751: enti- ties to further the goals of the program;
p.000751: (3) may, in accordance with section 496, and in consulta- tion with the National Advisory Council on
p.000751: Drug Abuse, ac- quire, construct, improve, repair, operate, and maintain pharmacotherapeutic research
p.000751: centers, laboratories, and other
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000751:
p.000751:
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p.000751: Sec. 464R PUBLIC HEALTH SERVICE ACT 752
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p.000751: necessary facilities and equipment, and such other real or per- sonal property as the Director determines necessary,
p.000751: and may, in consultation with such Advisory Council, make grants for the construction or renovation of
p.000751: facilities to carry out the pur- poses of this section;
p.000751: (4) may accept voluntary and uncompensated services;
p.000751: (5) may accept gifts, or donations of services, money, or property, real, personal, or mixed, tangible
p.000751: or intangible; and
p.000751: (6) shall take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge
p.000751: and information are maintained between the Institute and the other scientific, medical, and biomedical
p.000751: disciplines and organi- zations nationally and internationally.
p.000751: (c) REPORT.—
p.000751: (1) IN GENERAL.—Not later than December 31, 1992, and each December 31 thereafter, the Director of the
p.000751: Institute shall submit to the Office of National Drug Control Policy estab- lished under section 1002 of
p.000751: the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1501) a report, in accordance with paragraph (3), that
p.000751: describes the objectives and activities of the program as- sisted under this section.
p.000751: (2) NATIONAL DRUG CONTROL STRATEGY.—The Director of National Drug Control Policy shall incorporate, by
p.000751: reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy
p.000751: submitted the following Feb- ruary 1 under section 1005 of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
p.000751: (d) DEFINITION.—For purposes of this section, the term ‘‘pharmacotherapeutics’’ means medications used to
p.000751: treat the symp- toms and disease of drug abuse, including medications to—
p.000751: (1) block the effects of abused drugs;
p.000751: (2) reduce the craving for abused drugs;
p.000751: (3) moderate or eliminate withdrawal symptoms;
p.000751: (4) block or reverse the toxic effect of abused drugs; or
p.000751: (5) prevent relapse in persons who have been detoxified from drugs of abuse.
p.000751: Subpart 16—National Institute of Mental Health
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p.000751: January 30, 2020
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p.000751: PURPOSE OF INSTITUTE
p.000751: SEC. 464R. ø285p¿ (a) IN GENERAL.—The general purpose of the National Institute of Mental Health
p.000751: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of bio- medical
p.000751: and behavioral research, health services research, research training, and health information dissemination with respect
p.000751: to the cause, diagnosis, treatment, control and prevention of mental ill- ness.
p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000773: section through the Center with related activities of the Administrator for Health Care Policy and
p.000773: Research.
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p.000773: January 30, 2020
p.000773: PART E—OTHER AGENCIES OF NIH
p.000773: Subpart 1—National Center for Advancing Translational Sciences
p.000773: SEC. 479. ø287¿ NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.
p.000773: (a) PURPOSE.—The purpose of the National Center for Advanc- ing Translational Sciences (in this subpart referred to as
p.000773: the ‘‘Cen- ter’’) is to advance translational sciences, including by—
p.000773: (1) coordinating and developing resources that leverage basic research in support of translational science; and
p.000773: (2) developing partnerships and working cooperatively to foster synergy in ways that do not create
p.000773: duplication, redun- dancy, and competition with industry activities.
p.000773: (b) CLINICAL TRIAL ACTIVITIES.—
p.000773: (1) IN GENERAL.—The Center may develop and provide in- frastructure and resources for all phases of clinical
p.000773: trials re- search. Except as provided in paragraph (2), the Center may support clinical trials only through
p.000773: the end of phase IIB.
p.000773: (2) EXCEPTION.—The Center may support clinical trial ac- tivities through the end of phase III for a treatment
p.000773: for a rare disease or condition (as defined in section 526 of the Federal Food, Drug, and Cosmetic Act) so
p.000773: long as—
p.000773: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000773: Sec. 480 PUBLIC HEALTH SERVICE ACT 774
p.000773: (A) the Center gives public notice for a period of at least 120 days of the Center’s intention to support the
p.000773: clin- ical trial activities in phase III;
p.000773: (B) no public or private organization provides credible written intent to the Center that the organization has
p.000773: timely plans to further the clinical trial activities or con- duct clinical trials of a similar nature
p.000773: beyond phase IIB; and
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p.000773: (C) the Center ensures that support of the clinical trial activities in phase III will not increase the Federal
p.000773: Gov- ernment’s liability beyond the award value of the Center’s support.
p.000773: (c) BIENNIAL REPORT.—The Center shall publish a report on a biennial basis that, with respect to all research
p.000773: supported by the Center, includes a complete list of—
p.000773: (1) the molecules being studied;
p.000773: (2) clinical trial activities being conducted;
p.000773: (3) the methods and tools in development;
p.000773: (4) ongoing partnerships, including—
p.000773: (A) the rationale for each partnership;
p.000773: (B) the status of each partnership;
p.000773: (C) the funding provided by the Center to other enti- ties pursuant to each partnership, and
p.000773: (D) the activities which have been transferred to in- dustry pursuant to each partnership;
p.000773: (5) known research activity of other entities that is or will expand upon research activity of the Center;
p.000773: (6) the methods and tools, if any, that have been developed since the last biennial report was prepared; and
p.000773: (7) the methods and tools, if any, that have been developed and are being utilized by the Food and Drug Administration
p.000773: to support medical product reviews.
p.000773: (d) INCLUSION OF LIST.—The first biennial report submitted under this section after the date of enactment of the
p.000773: 21st Century Cures Act shall include a complete list of all of the methods and tools, if any, which
p.000773: have been developed by research supported by the Center.
p.000773: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as authorizing the Secretary to disclose
p.000773: any information that is a trade secret, or other privileged or confidential informa- tion subject to
p.000773: section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
p.000773: SEC. 480. ø287a¿ CURES ACCELERATION NETWORK.
p.000773: (a) DEFINITIONS.—In this section:
p.000773: (1) BIOLOGICAL PRODUCT.—The term ‘‘biological product’’ has the meaning given such term in section 351
p.000773: of the Public Health Service Act.
p.000773: (2) DRUG; DEVICE.—The terms ‘‘drug’’ and ‘‘device’’ have the meanings given such terms in section 201 of
p.000773: the Federal Food, Drug, and Cosmetic Act.
p.000773: (3) HIGH NEED CURE.—The term ‘‘high need cure’’ means a drug (as that term is defined by section 201(g)(1)
p.000773: of the Fed- eral Food, Drug, and Cosmetic Act, biological product (as that
p.000773: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000775: 775
p.000775: PUBLIC HEALTH SERVICE ACT
p.000775: Sec. 480
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p.000775: term is defined by section 262(i)), or device (as that term is de- fined by section 201(h) of the Federal Food,
p.000775: Drug, and Cos- metic Act) that, in the determination of the Director of the Center—
p.000775: (A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and
p.000775: (B) for which the incentives of the commercial market are unlikely to result in its adequate or timely
p.000775: develop- ment.
p.000775: (4) MEDICAL PRODUCT.—The term ‘‘medical product’’ means a drug, device, biological product, or product that is a
p.000775: combina- tion of drugs, devices, and biological products.
p.000775: (b) ESTABLISHMENT OF THE CURES ACCELERATION NETWORK.— Subject to the appropriation of funds as described in
p.000775: subsection (g), there is established within the Center a program to be known as the Cures Acceleration
p.000775: Network (referred to in this section as ‘‘CAN’’), which shall—
p.000775: (1) be under the direction of the Director of the Center, taking into account the recommendations of a
p.000775: CAN Review Board (referred to in this section as the ‘‘Board’’), described in subsection (d); and
p.000775: (2) award grants and contracts to eligible entities, as de- scribed in subsection (e), to accelerate the
p.000775: development of high need cures, including through the development of medical products and behavioral
p.000775: therapies.
p.000775: (c) FUNCTIONS.—The functions of the CAN are to—
p.000775: (1) conduct and support revolutionary advances in basic re- search, translating scientific discoveries from bench to
p.000775: bedside;
p.000775: (2) award grants and contracts to eligible entities to accel- erate the development of high need cures;
p.000775: (3) provide the resources necessary for government agen- cies, independent investigators, research
p.000775: organizations, bio- technology companies, academic research institutions, and other entities to develop
p.000775: high need cures;
p.000775: (4) reduce the barriers between laboratory discoveries and clinical trials for new therapies; and
p.000775: (5) facilitate review in the Food and Drug Administration for the high need cures funded by the CAN, through
p.000775: activities that may include—
p.000775: (A) the facilitation of regular and ongoing communica- tion with the Food and Drug Administration regarding the status
p.000775: of activities conducted under this section;
p.000775: (B) ensuring that such activities are coordinated with the approval requirements of the Food and Drug Adminis-
p.000775: tration, with the goal of expediting the development and approval of countermeasures and products; and
p.000775: (C) connecting interested persons with additional tech- nical assistance made available under section 565 of
p.000775: the Federal Food, Drug, and Cosmetic Act.
p.000775: (d) CAN BOARD.—
p.000775: (1) ESTABLISHMENT.—There is established a Cures Accel- eration Network Review Board (referred to in this
p.000775: section as the ‘‘Board’’), which shall advise the Director of the Center on the conduct of the activities of
p.000775: the Cures Acceleration Network.
p.000775: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000775: Sec. 480 PUBLIC HEALTH SERVICE ACT 776
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p.000775: January 30, 2020
p.000775:
p.000775: (2) MEMBERSHIP.—
p.000775: (A) IN GENERAL.—
p.000775: (i) APPOINTMENT.—The Board shall be comprised of 24 members who are appointed by the Secretary and who
p.000775: serve at the pleasure of the Secretary.
p.000775: (ii) CHAIRPERSON AND VICE CHAIRPERSON.—The Secretary shall designate, from among the 24 mem- bers
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p.000777: PUBLIC HEALTH SERVICE ACT
p.000777: Sec. 480
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p.000777: (i) a representative of the National Institutes of Health, recommended by the Secretary of the Depart-
p.000777: ment of Health and Human Services;
p.000777: (ii) a representative of the Office of the Assistant Secretary of Defense for Health Affairs, recommended by
p.000777: the Secretary of Defense;
p.000777: (iii) a representative of the Office of the Under Secretary for Health for the Veterans Health Adminis-
p.000777: tration, recommended by the Secretary of Veterans Af- fairs;
p.000777: (iv) a representative of the National Science Foun- dation, recommended by the Chair of the National Science
p.000777: Board; and
p.000777: (v) a representative of the Food and Drug Admin- istration, recommended by the Commissioner of Food and Drugs.
p.000777: (B) TERMS.—Each ex-officio member shall serve a 3- year term on the Board, except that the Chairperson may
p.000777: adjust the terms of the initial ex-officio members in order to provide for a staggered term of appointment for
p.000777: all such members.
p.000777: (4) RESPONSIBILITIES OF THE BOARD AND THE DIRECTOR OF THE CENTER.—
p.000777: (A) RESPONSIBILITIES OF THE BOARD.—
p.000777: (i) IN GENERAL.—The Board shall advise, and pro- vide recommendations to, the Director of the Center with
p.000777: respect to—
p.000777: (I) policies, programs, and procedures for car- rying out the duties of the Director of the Center under this
p.000777: section; and
p.000777: (II) significant barriers to successful trans- lation of basic science into clinical application (in- cluding
p.000777: issues under the purview of other agencies and departments).
p.000777: (ii) REPORT.—In the case that the Board identifies a significant barrier, as described in clause (i)(II), the
p.000777: Board shall submit to the Secretary a report regarding such barrier.
p.000777: (B) RESPONSIBILITIES OF THE DIRECTOR OF THE CEN- TER.—With respect to each recommendation provided
p.000777: by the Board under subparagraph (A)(i), the Director of the Center shall respond in writing to the
p.000777: Board, indicating whether such Director will implement such recommenda- tion. In the case that the
p.000777: Director of the Center indicates a recommendation of the Board will not be implemented, such Director
p.000777: shall provide an explanation of the reasons for not implementing such recommendation.
p.000777: (5) MEETINGS.—
p.000777: (A) IN GENERAL.—The Board shall meet 4 times per calendar year, at the call of the Chairperson.
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p.000777: under section 5315 of title 5, United States Code, for each day (including travel time) during which the
p.000777: member is engaged in the performance of the duties of the Board. All members of the Board who are officers or
p.000777: employees of the United States shall serve without compensation in ad- dition to that received for their services
p.000777: as officers or em- ployees of the United States.
p.000777: (B) TRAVEL EXPENSES.—Members of the Board shall be allowed travel expenses, including per diem in lieu of sub-
p.000777: sistence, at rates authorized for persons employed inter- mittently by the Federal Government under
p.000777: section 5703(b) of title 5, United States Code, while away from their homes or regular places of
p.000777: business in the perform- ance of services for the Board.
p.000777: (e) GRANT PROGRAM.—
p.000777: (1) SUPPORTING INNOVATION.—To carry out the purposes described in this section, the Director of the
p.000777: Center shall award contracts, grants, or cooperative agreements to the enti- ties described in paragraph (2), to—
p.000777: (A) promote innovation in technologies supporting the advanced research and development and production
p.000777: of high need cures, including through the development of medical products and behavioral therapies.
p.000777: (B) accelerate the development of high need cures, in- cluding through the development of medical products, be-
p.000777: havioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or
p.000777: (C) help the award recipient establish protocols that comply with Food and Drug Administration standards and
p.000777: otherwise permit the recipient to meet regulatory require- ments at all stages of development, manufacturing, review,
p.000777: approval, and safety surveillance of a medical product.
p.000777: (2) ELIGIBLE ENTITIES.—To receive assistance under para- graph (1), an entity shall—
p.000777: (A) be a public or private entity, which may include a private or public research institution, an institution of
p.000777: higher education, a medical center, a biotechnology com- pany, a pharmaceutical company, a disease advocacy
p.000777: orga-
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p.000779: PUBLIC HEALTH SERVICE ACT
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p.000779: nization, a patient advocacy organization, or an academic research institution;
p.000779: (B) submit an application containing—
p.000779: (i) a detailed description of the project for which the entity seeks such grant or contract;
p.000779: (ii) a timetable for such project;
p.000779: (iii) an assurance that the entity will submit—
p.000779: (I) interim reports describing the entity’s— (aa) progress in carrying out the project;
p.000779: and
p.000779: (bb) compliance with all provisions of this
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p.000779: section and conditions of receipt of such grant or contract; and
p.000779: (II) a final report at the conclusion of the grant period, describing the outcomes of the project;
p.000779: and
p.000779: (iv) a description of the protocols the entity will follow to comply with Food and Drug Administration
p.000779: standards and regulatory requirements at all stages of development, manufacturing, review, approval, and safety
p.000779: surveillance of a medical product; and
p.000779: (C) provide such additional information as the Director of the Center may require.
p.000779: (3) AWARDS.—
p.000779: (A) THE CURES ACCELERATION PARTNERSHIP AWARDS.—
p.000779: (i) INITIAL AWARD AMOUNT.—Each award under this subparagraph shall be not more than $15,000,000 per project
p.000779: for the first fiscal year for which the project is funded, which shall be payable in one pay-
p.000779: ment.
p.000779: (ii) FUNDING IN SUBSEQUENT FISCAL YEARS.—An eligible entity receiving an award under clause (i) may apply for
p.000779: additional funding for such project by sub- mitting to the Director of the Center the information
p.000779: required under subparagraphs (B) and (C) of para- graph (2). The Director may fund a project of such eli- gible
p.000779: entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award under clause
p.000779: (i).
p.000779: (iii) MATCHING FUNDS.—As a condition for receiv- ing an award under this subsection, an eligible entity
p.000779: shall contribute to the project non-Federal funds in the amount of $1 for every $3 awarded under
p.000779: clauses
p.000779: (i) and (ii), except that the Director of the Center may waive or modify such matching requirement in any case
p.000779: where the Director determines that the goals and objectives of this section cannot adequately be carried out
p.000779: unless such requirement is waived.
p.000779: (B) THE CURES ACCELERATION GRANT AWARDS.—
p.000779: (i) INITIAL AWARD AMOUNT.—Each award under this subparagraph shall be not more than $15,000,000 per project
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p.000779: entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award
p.000779: under clause (i).
p.000779: (C) THE CURES ACCELERATION FLEXIBLE RESEARCH AWARDS.—If the Director of the Center determines that the
p.000779: goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative
p.000779: agree- ment, the Director of the Center shall have flexible re- search authority to use other transactions to
p.000779: fund projects in accordance with the terms and conditions of this sec- tion. Awards made under such
p.000779: flexible research authority for a fiscal year shall not exceed 20 percent of the total funds appropriated
p.000779: under subsection (g)(1) for such fiscal year.
p.000779: (4) SUSPENSION OF AWARDS FOR DEFAULTS, NONCOMPLI-
p.000779: ANCE WITH PROVISIONS AND PLANS, AND DIVERSION OF FUNDS;
p.000779: REPAYMENT OF FUNDS.—The Director of the Center may sus- pend the award to any entity upon noncompliance by such
p.000779: en- tity with provisions and plans under this section or diversion of funds.
p.000779: (5) AUDITS.—The Director of the Center may enter into agreements with other entities to conduct periodic audits
p.000779: of the projects funded by grants or contracts awarded under this sub- section.
p.000779: (6) CLOSEOUT PROCEDURES.—At the end of a grant or con- tract period, a recipient shall follow the closeout
p.000779: procedures under section 74.71 of title 45, Code of Federal Regulations (or any successor regulation).
p.000779: (7) REVIEW.—A determination by the Director of the Cen- ter as to whether a drug, device, or biological product
p.000779: is a high need cure (for purposes of subsection (a)(3)) shall not be subject to judicial review.
p.000779: (f) COMPETITIVE BASIS OF AWARDS.—Any grant, cooperative agreement, or contract awarded under this section shall
p.000779: be award- ed on a competitive basis.
p.000779: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000779: (1) IN GENERAL.—For purposes of carrying out this section, there are authorized to be appropriated $500,000,000 for
p.000779: fiscal year 2010, and such sums as may be necessary for subsequent fiscal years. Funds appropriated under this
p.000779: section shall be available until expended.
p.000779: (2) LIMITATION ON USE OF FUNDS OTHERWISE APPRO- PRIATED.—No funds appropriated under this Act,
p.000779: other than funds appropriated under paragraph (1), may be allocated to the Cures Acceleration Network.
p.000779: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000781: 781
p.000781: PUBLIC HEALTH SERVICE ACT
p.000781: Sec. 481A
p.000781:
p.000781: OFFICE OF RARE DISEASES
p.000781: SEC. 481. ø287a–1¿ (a) ESTABLISHMENT.—There is established within the Center an office to be known as the Office
p.000781: of Rare Dis- eases (in this section referred to as the ‘‘Office’’), which shall be headed by a Director (in
p.000781: this section referred to as the ‘‘Director’’), appointed by the Director of the Center.
p.000781: (b) DUTIES.—
p.000781: (1) IN GENERAL.—The Director of the Office shall carry out the following:
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p.000781: RARE DISEASE REGIONAL CENTERS OF EXCELLENCE
p.000781: SEC. 481A. ø287a–2¿ (a) COOPERATIVE AGREEMENTS AND
p.000781: GRANTS.—
p.000781: (1) IN GENERAL.—The Director of the Office of Rare Dis- eases (in this section referred to as the
p.000781: ‘‘Director’’), in collabo- ration with the directors of the other relevant institutes and centers of the
p.000781: National Institutes of Health, may enter into co- operative agreements with and make grants to public or pri-
p.000781: vate nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing
p.000781: basic operating support for regional centers of excellence for clinical research
p.000781: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000781:
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p.000781: Sec. 481B PUBLIC HEALTH SERVICE ACT 782
p.000781:
p.000781: into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for rare
p.000781: diseases.
p.000781: (2) POLICIES.—A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with
p.000781: policies established by the Director of NIH.
p.000781: (b) COORDINATION WITH OTHER INSTITUTES.—The Director shall coordinate the activities under this section
p.000781: with similar activi- ties conducted by other national research institutes, centers and agencies of the
p.000781: National Institutes of Health and by the Food and Drug Administration to the extent that such institutes,
p.000781: centers and agencies have responsibilities that are related to rare diseases.
p.000781: (c) USES FOR FEDERAL PAYMENTS UNDER COOPERATIVE AGREE- MENTS OR GRANTS.—Federal payments made under a
p.000781: cooperative agreement or grant under subsection (a) may be used for—
p.000781: (1) staffing, administrative, and other basic operating costs, including such patient care costs as
p.000781: are required for re- search;
p.000781: (2) clinical training, including training for allied health professionals, continuing education for health
p.000781: professionals and allied health professions personnel, and information programs for the public with respect to
p.000781: rare diseases; and
p.000781: (3) clinical research and demonstration programs.
p.000781: (d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—Support of a center under subsection (a) may be for a
p.000781: period of not to exceed 5 years. Such period may be extended by the Director for additional periods of
p.000781: not more than 5 years if the operations of such center have been reviewed by an appropriate technical and
p.000781: scientific peer review group established by the Director and if such group has rec- ommended to the Director that such
p.000781: period should be extended.
p.000781: SEC. 481B. ø287a–3¿ GENERAL CLINICAL RESEARCH CENTERS.
p.000781: (a) GRANTS.—The Director of the Center shall award grants for the establishment of general clinical research centers to
p.000781: provide the infrastructure for clinical research including clinical research train- ing and career enhancement.
p.000781: Such centers shall support clinical studies and career development in all settings of the hospital or
p.000781: academic medical center involved.
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p.000783: (D) scientific issues arising in connection with the la- beling and composition of dietary supplements;
p.000783: (4) compile a database of scientific research on dietary sup- plements and individual nutrients; and
p.000783:
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p.000783: January 30, 2020
p.000783: 50 Subpart 3 of this part was transferred and redesignated as subpart 19 of part C by section 101(c) of Public Law
p.000783: 109–482.
p.000783: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000783:
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p.000783: Sec. 485D PUBLIC HEALTH SERVICE ACT 784
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p.000783: January 30, 2020
p.000783:
p.000783: (5) coordinate funding relating to dietary supplements for the National Institutes of Health.
p.000783: (d) DEFINITION.—As used in this section, the term ‘‘dietary sup- plement’’ has the meaning given the term in
p.000783: section 201(ff) of the Federal Food, Drug, and Cosmetic Act.
p.000783: Subpart 5—National Center for Complementary and Integrative Health
p.000783: SEC. 485D. ø287c–21¿ PURPOSE OF CENTER.
p.000783: (a) IN GENERAL.—The general purposes of the National Center for Complementary and Integrative Health (in this
p.000783: subpart re- ferred to as the ‘‘Center’’) are the conduct and support of basic and applied research (including both
p.000783: intramural and extramural re- search), research training, the dissemination of health information, and other
p.000783: programs with respect to identifying, investigating, and validating complementary and integrative health,
p.000783: diagnostic and prevention modalities, disciplines and systems. The Center shall be headed by a director, who shall be
p.000783: appointed by the Secretary. The Director of the Center shall report directly to the Director of NIH.
p.000783: (b) ADVISORY COUNCIL.—The Secretary shall establish an advi- sory council for the Center in accordance with
p.000783: section 406, except that at least half of the members of the advisory council who are not ex officio
p.000783: members shall include practitioners licensed in one or more of the major systems with which the Center is concerned,
p.000783: and at least 3 individuals representing the interests of individual con- sumers of complementary and
p.000783: integrative health.
p.000783: (c) In carrying out subsection (a), the Director of the Center shall, as appropriate, study the
p.000783: integration of new and non-tradi- tional approaches to health care treatment and consumption, in- cluding
p.000783: but not limited to non-traditional treatment, diagnostic and prevention systems, modalities, and disciplines.
p.000783: (d) APPROPRIATE SCIENTIFIC EXPERTISE AND COORDINATION WITH INSTITUTES AND FEDERAL AGENCIES.—The
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p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
p.000787: Advi- sory Committee on Research on Women’s Health (in this sub- section referred to as the ‘‘Advisory
p.000787: Committee’’).
p.000787: (2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not
p.000787: officers or employees of the Federal Government. The Director of NIH shall make appointments to the Advisory
p.000787: Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical
p.000787: practice, research specialization, or professional expertise includes a significant focus on re- search on
p.000787: women’s health. A majority of the members of the Advisory Committee shall be women.
p.000787: (3) The Director of the Office shall serve as the chair of the Advisory Committee.
p.000787: (4) The Advisory Committee shall—
p.000787: (A) advise the Director of the Office on appropriate re- search activities to be undertaken by the national research
p.000787: institutes with respect to—
p.000787: (i) research on women’s health;
p.000787: (ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
p.000787: (iii) research on gender differences in disease eti- ology, course, and treatment;
p.000787: (iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and
p.000787: (v) research on women’s health conditions which require a multidisciplinary approach;
p.000787: (B) report to the Director of the Office on such re- search;
p.000787: (C) provide recommendations to such Director regard- ing activities of the Office (including
p.000787: recommendations on the development of the methodologies described in sub- section (c)(4)(C) and recommendations
p.000787: on priorities in car- rying out research described in subparagraph (A)); and
p.000787: (D) assist in monitoring compliance with section 492B regarding the inclusion of women in clinical research. (5)(A) The
p.000787: Advisory Committee shall prepare a biennial re-
p.000787: port describing the activities of the Committee, including find- ings made by the Committee regarding—
p.000787: (i) compliance with section 492B;
p.000787: (ii) the extent of expenditures made for research on women’s health by the agencies of the National
p.000787: Institutes of Health; and
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000789: President and the Congress under section 403.
p.000789: PART G—AWARDS AND TRAINING
p.000789: RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS 51
p.000789: SEC. 487. ø288¿ (a)(1) The Secretary shall—
p.000789: (A) provide Ruth L. Kirschstein National Research Service Awards 52 for—
p.000789: (i) biomedical and behavioral research at the National Institutes of Health in matters relating to the cause, diag-
p.000789: nosis, prevention, and treatment of the diseases or other health problems to which the activities of the
p.000789: National In- stitutes of Health and Administration 53 are directed;
p.000789: (ii) training at the National Institutes of Health and at the Administration 53 of individuals to
p.000789: undertake such research;
p.000789: (iii) biomedical and behavioral research and health services research (including research in primary
p.000789: medical care) at public and nonprofit private entities; and
p.000789:
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p.000789: January 30, 2020
p.000789: 51 The typeface is so in law. See section 804(b) of Public Law 107–206 (116 Stat. 874).
p.000789: 52 Section 804(c) of Public Law 107–206 (116 Stat. 874) provides as follows:
p.000789: ‘‘(c) Any reference in any law (other than this Act), regulation, document, record, map, or other paper
p.000789: of the United States to ‘National Research Service Awards’ shall be considered to be a reference to ‘Ruth
p.000789: L. Kirschstein National Research Service Awards’ ’’.
p.000789: 53 So in law. Section 163(b)(4)(B) of Public Law 102–321 (106 Stat. 376) struck a reference in paragraph
p.000789: (1) to the former Alcohol, Drug Abuse, and Mental Health Administration, but failed to conform related
p.000789: references.
p.000789: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000789:
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p.000789: Sec. 487 PUBLIC HEALTH SERVICE ACT 790
p.000789:
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p.000789: January 30, 2020
p.000789:
p.000789: (iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake
p.000789: bio- medical and behavioral research;
p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
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p.000807: January 30, 2020
p.000807: PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST IN CERTAIN PROJECTS OF RESEARCH
p.000807: SEC. 493A. ø289b–1¿ (a) ISSUANCE OF REGULATIONS.—The Sec-
p.000807: retary shall by regulation define the specific circumstances that constitute the existence of a financial
p.000807: interest in a project on the part of an entity or individual that will, or may be reasonably ex-
p.000807: pected to, create a bias in favor of obtaining results in such project that are consistent with such financial
p.000807: interest. Such definition shall apply uniformly to each entity or individual conducting a re- search project under
p.000807: this Act. In the case of any entity or indi- vidual receiving assistance from the Secretary for a
p.000807: project of re- search described in subsection (b), the Secretary shall by regulation establish standards for
p.000807: responding to, including managing, reduc- ing, or eliminating, the existence of such a financial interest.
p.000807: The entity may adopt individualized procedures for implementing the standards.
p.000807: (b) RELEVANT PROJECTS.—A project of research referred to in subsection (a) is a project of clinical
p.000807: research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment
p.000807: and for which such entity is receiving assistance from the Secretary.
p.000807: (c) IDENTIFYING AND REPORTING TO SECRETARY.—The Secretary shall by regulation require that each entity described in
p.000807: subsection
p.000807: (a) that applies for assistance under this Act for any project de- scribed in subsection (b) submit in
p.000807: or with its application for such assistance—
p.000807: (1) assurances satisfactory to the Secretary that such enti- ty has established and has in effect an
p.000807: administrative process under subsection (a) to identify financial interests (as defined under subsection (a))
p.000807: that exist regarding the project; and
p.000807: (2) an agreement that the entity will report to the Sec- retary such interests identified by the entity and
p.000807: how any such interests identified by the entity will be managed or eliminated in order that the project in question
p.000807: will be protected from bias that may stem from such interests; and
p.000807: (3) an agreement that the entity will comply with regula- tions issued under this section.
p.000807: (d) MONITORING OF PROCESS.—The Secretary shall monitor the establishment and conduct of the administrative
p.000807: process estab- lished by an entity pursuant to subsection (a).
p.000807: (e) RESPONSE.—In any case in which the Secretary determines that an entity has failed to comply with subsection (c)
p.000807: regarding a project of research described in subsection (b), the Secretary—
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000807: Sec. 494 PUBLIC HEALTH SERVICE ACT 808
p.000807:
p.000807: (1) shall require that, as a condition of receiving assist- ance, the entity disclose the existence of a
p.000807: financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and
p.000807: (2) may take such other actions as the Secretary deter- mines to be appropriate.
p.000807: (f) DEFINITIONS.—For purposes of this section:
p.000807: (1) The term ‘‘financial interest’’ includes the receipt of consulting fees or honoraria and the ownership of
p.000807: stock or eq- uity.
p.000807: (2) The term ‘‘assistance’’, with respect to conducting a project of research, means a grant, contract,
p.000807: or cooperative agreement.
p.000807: RESEARCH ON PUBLIC HEALTH EMERGENCIES
p.000807: SEC. 494. ø289c¿ If the Secretary determines, after consulta- tion with the Director of NIH, the
p.000807: Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and
p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
p.000807: part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental
p.000807: health be used collaboratively, as appropriate, and in consultation with the Agency for Health Care
p.000807: Policy Re- search.
p.000807:
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p.000807: January 30, 2020
p.000807: ANIMALS IN RESEARCH
p.000807: SEC. 495. ø289d¿ (a) The Secretary, acting through the Direc- tor of NIH, shall establish guidelines for the
p.000807: following:
p.000807: (1) The proper care of animals to be used in biomedical and behavioral research.
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000809: PUBLIC HEALTH SERVICE ACT
p.000809: Sec. 495
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p.000809: (2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall
p.000809: require—
...

p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
p.000813: (3) The term ‘‘valuable consideration’’ does not include rea- sonable payments associated with the transportation,
p.000813: implan- tation, processing, preservation, quality control, or storage of human fetal tissue.
p.000813: SEC. 498C. ø289g–3¿ BREAST IMPLANT RESEARCH.
p.000813: (a) IN GENERAL.—The Director of NIH may conduct or support research to examine the long-term health implications
p.000813: of silicone
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000815: 815
p.000815: PUBLIC HEALTH SERVICE ACT
p.000815: Sec. 498D
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p.000815: January 30, 2020
p.000815: breast implants, both gel and saline filled. Such research studies may include the following:
p.000815: (1) Developing and examining techniques to measure con- centrations of silicone in body fluids and tissues.
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p.000815: Medicine Ini- tiative’’ (in this section referred to as the ‘‘Initiative’’), to augment efforts to address
p.000815: disease prevention, diagnosis, and treatment.
p.000815: (b) COMPONENTS.—The Initiative described under subsection
p.000815: (a) may include—
p.000815: (1) developing a network of scientists to assist in carrying out the purposes of the Initiative;
p.000815: (2) developing new approaches for addressing scientific, medical, public health, and regulatory science issues;
p.000815: (3) applying genomic technologies, such as whole genomic sequencing, to provide data on the molecular
p.000815: basis of disease;
p.000815: (4) collecting information voluntarily provided by a diverse cohort of individuals that can be used to better
p.000815: understand health and disease; and
p.000815: (5) other activities to advance the goals of the Initiative, as the Secretary determines appropriate.
p.000815: (c) AUTHORITY OF THE SECRETARY.—In carrying out this sec- tion, the Secretary may—
p.000815: (1) coordinate with the Secretary of Energy, private indus- try, and others, as the Secretary determines
p.000815: appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the
p.000815: Initiative;
p.000815: (2) develop and utilize public-private partnerships; and
p.000815: (3) leverage existing data sources.
p.000815: (d) REQUIREMENTS.—In the implementation of the Initiative under subsection (a), the Secretary shall—
p.000815: (1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, the
p.000815: Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of
p.000815: the Department of Health and Human Services;
p.000815: (2) comply with existing laws and regulations for the pro- tection of human subjects involved in
p.000815: research, including the protection of participant privacy;
p.000815: (3) implement policies and mechanisms for appropriate se- cure data sharing across systems that include
p.000815: protections for privacy and security of data;
p.000815: (4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration
p.000815: of bio- logical, social, and other determinants of health that contribute to health disparities;
p.000815: (5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological
p.000815: material and as- sociated information collected or stored in connection with the Initiative; and
p.000815: (6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities
p.000815: with ac- cess to such information and provide information with respect to the purpose of such access, a
p.000815: summary of the research project for which such access is granted, as applicable, and a description of
p.000815: the biological material and associated informa- tion to which the entity has access.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000825:
p.000825: opment of national mental health and substance use disorder goals and model programs;
p.000825: (6) in cooperation with the National Institutes of Health, the Centers for Disease Control and
p.000825: Prevention, and the Health Resources and Services Administration, develop edu- cational materials and
p.000825: intervention strategies to reduce the risks of HIV, hepatitis, tuberculosis, and other communicable diseases
p.000825: among individuals with mental or substance use dis- orders, and to develop appropriate mental health
p.000825: services for individuals with such diseases or disorders;
p.000825: (7) coordinate Federal policy with respect to the provision of treatment services for substance use
p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
p.000825: delivery and effectiveness of prevention, treat- ment, and recovery support services and are appropriately
p.000825: in- corporated into programs carried out by the Administration;
p.000825: (10) encourage public and private entities that provide health insurance to provide benefits for substance use
p.000825: disorder and mental health services;
p.000825: (11) work with relevant agencies of the Department of Health and Human Services on integrating mental health
p.000825: pro- motion and substance use disorder prevention with general health promotion and disease prevention and
p.000825: integrating men- tal and substance use disorders treatment services with phys- ical health treatment services;
p.000825: (12) monitor compliance by hospitals and other facilities with the requirements of sections 542 and 543;
p.000825: (13) with respect to grant programs authorized under this title or part B of title XIX, or grant programs otherwise
p.000825: funded by the Administration—
p.000825: (A) require that all grants that are awarded for the provision of services are subject to performance
p.000825: and out- come evaluations;
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p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
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p.000837:
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p.000837: January 30, 2020
p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
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p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000839: 839
p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
p.000839: (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.
p.000839: ADVISORY COUNCILS
p.000839: SEC. 502. ø290aa–1¿ (a) APPOINTMENT.—
p.000839: (1) IN GENERAL.—The Secretary shall appoint an advisory council for—
p.000839: (A) the Substance Abuse and Mental Health Services Administration;
p.000839: (B) the Center for Substance Abuse Treatment;
p.000839: (C) the Center for Substance Abuse Prevention; and
p.000839: (D) the Center for Mental Health Services.
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p.000839: Sec. 502 PUBLIC HEALTH SERVICE ACT 840
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p.000839:
p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
p.000839: members to be appointed by the Secretary under paragraph (3).
p.000839: (2) EX OFFICIO MEMBERS.—The ex officio members of an advisory council shall consist of—
p.000839: (A) the Secretary;
p.000839: (B) the Assistant Secretary;
p.000839: (C) the Director of the Center for which the council is established;
p.000839: (D) the Under Secretary for Health of the Department of Veterans Affairs;
p.000839: (E) the Assistant Secretary for Defense for Health Af- fairs (or the designates of such officers);
p.000839: (F) the Chief Medical Officer, appointed under section 501(g);
p.000839: (G) the Director of the National Institute of Mental Health for the advisory councils appointed
p.000839: under sub- sections (a)(1)(A) and (a)(1)(D);
p.000839: (H) the Director of the National Institute on Drug Abuse for the advisory councils appointed under
p.000839: sub- sections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.000839: (I) the Director of the National Institute on Alcohol Abuse and Alcoholism for the advisory councils
p.000839: appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and
p.000839: (J) such additional officers or employees of the United States as the Secretary determines necessary for the advi- sory
p.000839: council to effectively carry out its functions.
p.000839: (3) APPOINTED MEMBERS.—Individuals shall be appointed to an advisory council under paragraph (1) as follows:
p.000839: (A) Nine of the members shall be appointed by the Secretary from among the leading representatives of
p.000839: the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
p.000839: the Admin- istration or Center for which the advisory council is estab- lished.
p.000839: (B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders
p.000839: in fields of public policy, public relations, law, health policy economics, or management.
p.000839: (C) Not less than half of the members of the advisory council appointed under subsection (a)(1)(D)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree in psychology; or
p.000839: (III) have an advanced degree in nursing or social work from an accredited graduate school or be a certified
p.000839: physician assistant; and
p.000839: (ii) shall specialize in the mental health field.
...

p.000841: advisory council. The Assistant Secretary or Director shall make available to the advisory council such staff,
p.000841: information, and other assistance
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000841: Sec. 503 PUBLIC HEALTH SERVICE ACT 842
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p.000841: as it may require to carry out its functions. The Assistant Sec- retary or Director shall provide
p.000841: orientation and training for new members of the advisory council to provide for their effective par-
p.000841: ticipation in the functions of the advisory council.
p.000841: REPORTS ON ALCOHOLISM, ALCOHOL ABUSE, AND DRUG ABUSE
p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
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p.000843: characteristics of individuals receiving such treatment, the percentage of individ-
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p.000843: ‘‘The Secretary of Health and Human Services shall develop a public health monitoring pro- gram to monitor
p.000843: methamphetamine abuse in the United States. The program shall include the collection and dissemination of data
p.000843: related to methamphetamine abuse which can be used by public health officials in policy development.’’.
p.000843: 3 So in law. The period at the end of subparagraph (B) probably should be a semicolon.
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p.000845: PUBLIC HEALTH SERVICE ACT
p.000845: Sec. 506
p.000845:
p.000845: uals who complete such programs, and, with respect to individ- uals receiving such treatment, the length of time
p.000845: between an individual’s request for treatment and the commencement of treatment;
p.000845: (E) the number of such individuals who return for treat- ment after the completion of a prior treatment
p.000845: in such pro- grams and the method of treatment utilized during the prior treatment;
p.000845: (F) the number of individuals receiving public assistance for such treatment programs;
p.000845: (G) the costs of the different types of treatment modalities for drug and alcohol abuse and the aggregate
p.000845: relative costs of each such treatment modality provided within a State in each fiscal year;
p.000845: (H) to the extent of available information, the number of individuals receiving treatment for alcohol or
p.000845: drug abuse who have private insurance coverage for the costs of such treat- ment;
p.000845: (I) the extent of alcohol and drug abuse among high school students and among the general population; and
p.000845: (J) the number of alcohol and drug abuse counselors and other substance abuse treatment personnel employed in
p.000845: public and private treatment facilities.
p.000845: (2) ANNUAL SURVEYS; PUBLIC AVAILABILITY OF DATA.—Annual survey 4s shall be carried out in the
p.000845: collection of data under this subsection. Summaries and analyses of the data collected shall be made
p.000845: available to the public.
p.000845: (e) CONSULTATION.—After consultation with the States and with appropriate national organizations, the
p.000845: Assistant Secretary shall use existing standards and best practices to develop uniform criteria for the
p.000845: collection of data, using the best available tech- nology, pursuant to this section.
p.000845: SEC. 506. ø290aa–5¿ GRANTS FOR THE BENEFIT OF HOMELESS INDIVID- UALS.
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts and cooperative agreements to community-based public
p.000845: and private nonprofit entities for the purposes of providing mental health and substance use disorder
p.000845: services for homeless individuals. In car- rying out this section, the Secretary shall consult with the
p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
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p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
p.000845: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000845: shall give priority to applicants that—
p.000845: (1) propose to provide alcohol and drug prevention or treat- ment services on reservations;
p.000845: (2) propose to employ culturally-appropriate approaches, as determined by the Secretary, in providing such services;
p.000845: and
p.000845: (3) have provided prevention or treatment services to Na- tive Alaskan entities and Indian tribes and tribal
p.000845: organizations for at least 1 year prior to applying for a grant under this sec- tion.
p.000845: (c) DURATION.—The Secretary shall award grants, contracts, or cooperative agreements under subsection (a) for a period
p.000845: not to ex- ceed 5 years.
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p.000845: January 30, 2020
p.000845: 5 Section 3307 of Public Law 106–310 (114 Stat. 1216) establishes a Commission on Indian and Native
p.000845: Alaskan Health Care and provides that the Commission ‘‘shall examine the health concerns of Indians and
p.000845: Native Alaskans who reside on reservations and tribal lands’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
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p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
p.000847: (5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the
p.000847: National Institute on Alcohol Abuse and Alcoholism, and with the States to promote the study, dissemination, and
p.000847: implementation of research find- ings that will improve the delivery and effectiveness of treat- ment
p.000847: services;
p.000847: (6) collaborate with the Administrator of the Health Re- sources and Services Administration and the
p.000847: Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into
p.000847: the mainstream of the health care system of the United States of programs for providing treat- ment
p.000847: services;
p.000847: (7) evaluate plans submitted by the States pursuant to sec- tion 1932(a)(6) in order to determine whether the
p.000847: plans ade- quately provide for the availability, allocation, and effective- ness of treatment services;
p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
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p.000855: PUBLIC HEALTH SERVICE ACT
p.000855: Sec. 509
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p.000855: January 30, 2020
p.000855: (B) REPORT.—The Director of the Center for Behav- ioral Health Statistics and Quality, in coordination
p.000855: with the Director of the Center for Substance Abuse Treatment shall submit to the relevant committees of
p.000855: jurisdiction of the House of Representatives and the Senate a report on the evaluation under subparagraph
p.000855: (A). The report shall include, at a minimum—
p.000855: (i) outcomes information from the pilot program, including any resulting reductions in the use of alcohol and
p.000855: other drugs;
p.000855: (ii) engagement in treatment services;
p.000855: (iii) retention in the appropriate level and dura- tion of services;
p.000855: (iv) increased access to the use of medications ap- proved by the Food and Drug Administration for the
p.000855: treatment of substance use disorders in combination with counseling; and
p.000855: (v) other appropriate measures.
p.000855: (C) RECOMMENDATION.—The report under subpara- graph (B) shall include a recommendation by the Director
p.000855: of the Center for Substance Abuse Treatment as to wheth- er the pilot program under this subsection should be
p.000855: ex- tended.
p.000855: (6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For pur- poses of this subsection, the term ‘‘State substance abuse
p.000855: agen- cy’’ means, with respect to a State, the agency in such State that manages the Substance Abuse
p.000855: Prevention and Treatment Block Grant under part B of title XIX.
p.000855: (s) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000855: to be appropriated
p.000855: $29,931,000 for each of fiscal years 2019 through 2023. Of the amounts made available for a year
p.000855: pursuant to theprevious sen- tence to carry out this section, not more than25 percent of such amounts
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p.000855: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: 857
p.000857: PUBLIC HEALTH SERVICE ACT
p.000857: Sec. 513
p.000857:
p.000857: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000857: programs to dissemi- nate and apply the findings of the knowledge development and ap- plication, training and technical
p.000857: assistance programs, and targeted capacity response programs under this section to the general pub- lic, to
p.000857: health professionals and other interested groups. The Sec- retary shall make every effort to provide linkages
p.000857: between the find- ings of supported projects and State agencies responsible for car- rying out substance
p.000857: use disorder prevention and treatment pro- grams.
p.000857: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000857: $333,806,000 for each of fiscal years 2018 through 2022.
p.000857: ACTION BY NATIONAL INSTITUTE ON DRUG ABUSE AND STATES CONCERNING MILITARY FACILITIES
p.000857: SEC. 513. 7 ø290bb–6¿ (a) CENTER FOR SUBSTANCE ABUSE
p.000857: TREATMENT.—The Director of the Center for Substance Abuse Treatment shall—
p.000857: (1) coordinate with the agencies represented on the Com- mission on Alternative Utilization of Military
p.000857: Facilities the uti- lization of military facilities or parts thereof, as identified by such Commission,
p.000857: established under the National Defense Au- thorization Act of 1989, that could be utilized or renovated to
p.000857: house nonviolent persons for drug treatment purposes;
p.000857: (2) notify State agencies responsible for the oversight of drug abuse treatment entities and programs of the
p.000857: availability of space at the installations identified in paragraph (1); and
p.000857: (3) assist State agencies responsible for the oversight of drug abuse treatment entities and programs in
p.000857: developing methods for adapting the installations described in paragraph
p.000857: (1) into residential treatment centers.
p.000857: (b) STATES.—With regard to military facilities or parts thereof, as identified by the Commission on Alternative
p.000857: Utilization of Mili- tary Facilities established under section 3042 of the Comprehensive Alcohol Abuse, Drug Abuse,
p.000857: and Mental Health Amendments Act of 1988, that could be utilized or renovated to house nonviolent per- sons for
p.000857: drug treatment purposes, State agencies responsible for the oversight of drug abuse treatment
p.000857: entities and programs shall—
p.000857: (1) establish eligibility criteria for the treatment of individ- uals at such facilities;
p.000857: (2) select treatment providers to provide drug abuse treat- ment at such facilities;
p.000857: (3) provide assistance to treatment providers selected under paragraph (2) to assist such providers
p.000857: in securing fi- nancing to fund the cost of the programs at such facilities; and
p.000857: (4) establish, regulate, and coordinate with the military of- ficial in charge of the facility, work programs
p.000857: for individuals receiving treatment at such facilities.
p.000857:
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p.000857: January 30, 2020
p.000857: 7 Sections 510 through 512 were repealed by section 3301(c) of Public Law 106–310 (114 Stat.
p.000857: 1209).
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: Sec. 514 PUBLIC HEALTH SERVICE ACT 858
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p.000859: connection with the provision of treatment of problems related to heroin and other opioids; and
p.000859: (4) fund only those applications that specifically support recovery services as a critical component of
p.000859: the program in- volved.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000859: $25,000,000 for each of fiscal years 2017 through 2021.
p.000859: Subpart 2—Center for Substance Abuse Prevention
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p.000859: January 30, 2020
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p.000859: CENTER FOR SUBSTANCE ABUSE PREVENTION
p.000859: SEC. 515. ø290bb–21¿ (a) There is established in the Adminis- tration a Center for Substance Abuse Prevention
p.000859: (hereafter re- ferred to in this part as the ‘‘Prevention Center’’). The Prevention Center shall be
p.000859: headed by a Director appointed by the Secretary from individuals with extensive experience or academic
p.000859: qualifica- tions in the prevention of drug or alcohol abuse.
p.000859: (b) The Director of the Prevention Center shall—
p.000859: (1) sponsor regional workshops on the prevention of drug and alcohol abuse through the reduction of risk
p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
p.000861: under the Drug Free Schools and Communities Act of 1986;
p.000861: (9) support the development of model, innovative, commu- nity-based programs that reduce the risk of
p.000861: alcohol and drug abuse among young people and promote resiliency;
p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
...

p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
p.000865: foundations, and alcohol bev- erage industry trade associations and companies.
p.000865: (F) ANNUAL REPORT.—
p.000865: (i) IN GENERAL.—The Secretary, on behalf of the Committee, shall annually submit to the Congress a report
p.000865: that summarizes—
p.000865: (I) all programs and policies of Federal agen- cies designed to prevent and reduce underage
p.000865: drinking;
p.000865: (II) the extent of progress in preventing and reducing underage drinking nationally;
p.000865: (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
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p.000865: (IV) such other information regarding under- age drinking as the Secretary determines to be ap- propriate.
p.000865: (ii) CERTAIN INFORMATION.—The report under clause (i) shall include information on the following:
p.000865: (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not
p.000865: limited to Monitoring the Future, Youth Risk Behavior Surveillance System, the Na- tional Survey on Drug
p.000865: Use and Health, and the Fatality Analysis Reporting System.
p.000865: (II) Measures of the availability of alcohol from commercial and non-commercial sources to underage
p.000865: populations.
p.000865: (III) Measures of the exposure of underage populations to messages regarding alcohol in ad- vertising and
p.000865: the entertainment media as re- ported by the Federal Trade Commission.
p.000865: (IV) Surveillance data, including information on the onset and prevalence of underage drinking, consumption
p.000865: patterns and the means of underage access. The Secretary shall develop a plan to im- prove the collection,
p.000865: measurement and consistency of reporting Federal underage alcohol data.
p.000865: (V) Any additional findings resulting from re- search conducted or supported under subsection (f).
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: Sec. 519B PUBLIC HEALTH SERVICE ACT 866
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p.000867: adult-oriented media campaign, and the feasi- bility and the likely effectiveness of a national
p.000867: youth-focused media campaign to combat underage drinking.
p.000867: (3) CONSULTATION REQUIREMENT.—In carrying out the media campaign, the Secretary shall direct the entity
p.000867: carrying out the national adult-oriented media public service campaign to consult with interested parties
p.000867: including both the alcohol beverage industry and public health and consumer groups. The progress of this
p.000867: consultative process is to be covered in the re- port under paragraph (2).
p.000867: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection,
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (e) INTERVENTIONS.—
p.000867: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000867:
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p.000867: Sec. 519B PUBLIC HEALTH SERVICE ACT 868
p.000867:
p.000867: (1) COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO PREVENT UNDERAGE DRINKING.—
p.000867: (A) AUTHORIZATION OF PROGRAM.—The Assistant Sec- retary for Mental Health and Substance Use, in consulta-
p.000867: tion with the Director of the Office of National Drug Con- trol Policy, shall award, if the Assistant Secretary
p.000867: deter- mines that the Department of Health and Human Services is not currently conducting activities that duplicate
p.000867: activi- ties of the type described in this subsection, ‘‘enhancement grants’’ to eligible entities to design, test,
p.000867: evaluate and dis- seminate effective strategies to maximize the effectiveness of community-wide approaches to
p.000867: preventing and reducing underage drinking. This subsection is subject to the avail- ability of appropriations.
p.000867: (B) PURPOSES.—The purposes of this paragraph are
p.000867: to—
p.000867: (i) prevent and reduce alcohol use among youth in communities throughout the United States;
p.000867: (ii) strengthen collaboration among communities, the Federal Government, and State, local, and tribal
p.000867: governments;
p.000867: (iii) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;
p.000867: (iv) serve as a catalyst for increased citizen par- ticipation and greater collaboration among all
p.000867: sectors and organizations of a community that first dem- onstrates a long-term commitment to reducing
p.000867: alcohol use among youth;
p.000867: (v) disseminate to communities timely information regarding state-of-the-art practices and initiatives that have proven
p.000867: to be effective in preventing and reducing alcohol use among youth; and
p.000867: (vi) enhance, not supplant, effective local commu- nity initiatives for preventing and reducing alcohol use among
p.000867: youth.
...

p.000867: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph
p.000867: (C). Grants
p.000867: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000869: PUBLIC HEALTH SERVICE ACT
p.000869: Sec. 519B
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p.000869: under this paragraph shall not exceed $50,000 per year and may not exceed four years.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: not supplant, Federal and non-Federal funds available for carrying out the activities described in this
p.000869: paragraph.
p.000869: (F) EVALUATION.—Grants under this paragraph shall be subject to the same evaluation requirements and proce- dures
p.000869: as the evaluation requirements and procedures im- posed on recipients of drug free community grants.
p.000869: (G) DEFINITIONS.—For purposes of this paragraph, the term ‘‘eligible entity’’ means an organization that is
p.000869: cur- rently receiving or has received grant funds under the Drug-Free Communities Act of 1997 (21 U.S.C.
p.000869: 1521 et seq.).
p.000869: (H) ADMINISTRATIVE EXPENSES.—Not more than 6 per- cent of a grant under this paragraph may be expended for
p.000869: administrative expenses.
p.000869: (I) AUTHORIZATION OF APPROPRIATIONS.—There are au- thorized to be appropriated to carry out this paragraph
p.000869: $5,000,000 for each of the fiscal years 2018 through 2022.
p.000869: (2) GRANTS DIRECTED AT PREVENTING AND REDUCING ALCO- HOL ABUSE AT INSTITUTIONS OF HIGHER EDUCATION.—
p.000869: (A) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to eligible entities to enable the entities to
p.000869: prevent and reduce the rate of underage alcohol consump- tion including binge drinking among students at
p.000869: institu- tions of higher education.
p.000869: (B) APPLICATIONS.—An eligible entity that desires to receive a grant under this paragraph shall submit an
p.000869: ap- plication to the Secretary at such time, in such manner, and accompanied by such information as the
p.000869: Secretary may require. Each application shall include—
p.000869: (i) a description of how the eligible entity will work to enhance an existing, or where none exists to
p.000869: build a, statewide coalition;
p.000869: (ii) a description of how the eligible entity will tar- get underage students in the State;
p.000869: (iii) a description of how the eligible entity intends to ensure that the statewide coalition is actually im-
p.000869: plementing the purpose of this section and moving to- ward indicators described in subparagraph (D);
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p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
p.000899: (B) providing assistance in obtaining and coordinating social and maintenance services for the eligible homeless
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
p.000901: transportation serv- ices, and habilitation and rehabilitation services, prevocational and
p.000901: vocational services, and housing serv- ices;
p.000901: (C) providing assistance to the eligible homeless indi- vidual in obtaining income support services,
p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
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p.000911: recommendations under section 6021 of the Helping Families in Mental Health Crisis Reform Act of 2016 or
p.000911: priorities identified in the stra- tegic plan under section 501(l).
p.000911: (c) REQUIREMENTS.—The Assistant Secretary may establish minimum requirements for the applications
p.000911: submitted under sub- section (b), including applications related to the submission of re- search and
p.000911: evaluation.
p.000911: (d) REVIEW AND RATING.—
p.000911: (1) IN GENERAL.—The Assistant Secretary shall review ap- plications prior to public posting in accordance with
p.000911: subsection (a), and may prioritize the review of applications for evidence- based programs and practices that are
p.000911: related to topics in- cluded in the notice provided under subsection (b)(2).
p.000911: (2) SYSTEM.—In carrying out paragraph (1), the Assistant Secretary may utilize a rating and review
p.000911: system, which may include information on the strength of evidence associated with the evidence-based programs and
p.000911: practices and a rating of the methodological rigor of the research supporting the applica- tions.
p.000911: (3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant Secretary shall make the metrics used to evaluate
p.000911: applications under this section, and any resulting ratings of such applica- tions, publicly available.
p.000911: SEC. 544. ø290dd–3¿ GRANTS FOR REDUCING OVERDOSE DEATHS.
p.000911: (a) ESTABLISHMENT.—
p.000911: (1) IN GENERAL.—The Secretary shall award grants to eli- gible entities to expand access to drugs or devices
p.000911: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000911: suspected opioid overdose.
p.000911: (2) MAXIMUM GRANT AMOUNT.—A grant awarded under this section may not be for more than $200,000 per grant year.
p.000911: (3) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a Federally qualified
p.000911: health center (as defined in section 1861(aa) of the Social Security Act), an
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000913: PUBLIC HEALTH SERVICE ACT
p.000913: Sec. 544
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p.000913: opioid treatment program under part 8 of title 42, Code of Fed- eral Regulations, any practitioner dispensing
p.000913: narcotic drugs pursuant to section 303(g) of the Controlled Substances Act, or any other entity that the Secretary
p.000913: deems appropriate.
p.000913: (4) PRESCRIBING.—For purposes of this section, the term ‘‘prescribing’’ means, with respect to a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000913: opioid overdose, the practice of prescribing such drug or device—
p.000913: (A) in conjunction with an opioid prescription for pa- tients at an elevated risk of overdose;
p.000913: (B) in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act
p.000913: for the treatment of opioid use disorder;
p.000913: (C) to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or
p.000913: (D) in other circumstances in which a provider identi- fies a patient is at an elevated risk for an
p.000913: intentional or unintentional drug overdose from heroin or prescription opioid therapies.
p.000913: (b) APPLICATION.—To be eligible to receive a grant under this section, an eligible entity shall submit
p.000913: to the Secretary, in such form and manner as specified by the Secretary, an application that describes—
p.000913: (1) the extent to which the area to which the entity will furnish services through use of the grant
p.000913: is experiencing sig- nificant morbidity and mortality caused by opioid abuse;
p.000913: (2) the criteria that will be used to identify eligible pa- tients to participate in such program; and
p.000913: (3) a plan for sustaining the program after Federal support for the program has ended.
p.000913: (c) USE OF FUNDS.—An eligible entity receiving a grant under this section may use amounts under the
p.000913: grant for any of the fol- lowing activities, but may use not more than 20 percent of the grant funds
p.000913: for activities described in paragraphs (3) and (4):
p.000913: (1) To establish a program for prescribing a drug or device approved or cleared under the Federal Food, Drug,
p.000913: and Cos- metic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (2) To train and provide resources for health care providers and pharmacists on the prescribing of drugs or
p.000913: devices ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose.
p.000913: (3) To purchase drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000913: treat- ment of known or suspected opioid overdose, for distribution under the program described in paragraph
p.000913: (1).
p.000913: (4) To offset the co-payments and other cost sharing associ- ated with drugs or devices approved or cleared under the
p.000913: Fed- eral Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (5) To establish protocols to connect patients who have ex- perienced a drug overdose with appropriate treatment,
p.000913: includ-
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p.000913: Sec. 545 PUBLIC HEALTH SERVICE ACT 914
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p.000913: ing medication-assisted treatment and appropriate counseling and behavioral therapies.
p.000913: (d) EVALUATIONS BY RECIPIENTS.—As a condition of receipt of a grant under this section, an eligible
p.000913: entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities
p.000913: funded by the grant which contains such information as the Secretary may reasonably require.
p.000913: (e) REPORTS BY THE SECRETARY.—Not later than 5 years after the date on which the first grant under this
p.000913: section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of
p.000913: the Senate a report aggregating the in- formation received from the grant recipients for such year under
p.000913: subsection (d) and evaluating the outcomes achieved by the pro- grams funded by grants awarded under this
p.000913: section.
p.000913: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section, $5,000,000 for
p.000913: the period of fiscal years 2017 through 2021.
p.000913: SEC. 545. ø290ee¿ OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION GRANT PROGRAMS.
p.000913: (a) GRANTS TO STATES.—The Secretary shall make grants to States to—
p.000913: (1) implement strategies for pharmacists to dispense a drug or device approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, as
p.000913: appropriate, pursuant to a stand- ing order;
p.000913: (2) encourage pharmacies to dispense opioid overdose re- versal medication pursuant to a standing order;
p.000913: (3) develop or provide training materials that persons au- thorized to prescribe or dispense a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose may use to educate the public concerning—
p.000913: (A) when and how to safely administer such drug or device; and
p.000913: (B) steps to be taken after administering such drug or device; and
p.000913: (4) educate the public concerning the availability of drugs or devices approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose without
p.000913: a person-specific prescription.
p.000913: (b) CERTAIN REQUIREMENT.—A grant may be made under this section only if the State involved has authorized
p.000913: standing orders to be issued for drugs or devices approved or cleared under the Fed- eral Food, Drug, and
p.000913: Cosmetic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (c) PREFERENCE IN MAKING GRANTS.—In making grants under this section, the Secretary may give preference to States
p.000913: that have a significantly higher rate of opioid overdoses than the national av- erage, and that—
p.000913: (1) have not implemented standing orders regarding drugs or devices approved or cleared under the Federal Food,
p.000913: Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose;
p.000913: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: 915
p.000915: PUBLIC HEALTH SERVICE ACT
p.000915: Sec. 546
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p.000915: (2) authorize standing orders to be issued that permit com- munity-based organizations, substance abuse
p.000915: programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved or
p.000915: cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000915: opioid overdose; or
p.000915: (3) authorize standing orders to be issued that permit po- lice, fire, or emergency medical services
p.000915: agencies to acquire and administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose.
p.000915: (d) GRANT TERMS.—
p.000915: (1) NUMBER.—A State may not receive more than one grant under this section at a time.
p.000915: (2) PERIOD.—A grant under this section shall be for a pe- riod of 3 years.
p.000915: (3) LIMITATION.—A State may use not more than 20 per- cent of a grant under this section for educating the
p.000915: public pur- suant to subsection (a)(4).
p.000915: (e) APPLICATIONS.—To be eligible to receive a grant under this section, a State shall submit an application to
p.000915: the Secretary in such form and manner and containing such information as the Sec- retary may reasonably require,
p.000915: including detailed proposed expend- itures of grant funds.
p.000915: (f) REPORTING.—A State that receives a grant under this sec- tion shall, at least annually for the
p.000915: duration of the grant, submit a report to the Secretary evaluating the progress of the activities
p.000915: supported through the grant. Such reports shall include informa- tion on the number of pharmacies in the State
p.000915: that dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for
p.000915: emergency treatment of known or suspected opioid overdose under a standing order, and other
p.000915: information as the Secretary determines appropriate to evaluate the use of grant funds.
p.000915: (g) DEFINITIONS.—In this section the term ‘‘standing order’’ means a document prepared by a person
p.000915: authorized to prescribe medication that permits another person to acquire, dispense, or ad- minister medication
p.000915: without a person-specific prescription.
p.000915: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000915: (1) IN GENERAL.—To carry out this section, there are au- thorized to be appropriated $5,000,000 for the
p.000915: period of fiscal years 2017 through 2019.
p.000915: (2) ADMINISTRATIVE COSTS.—Not more than 3 percent of the amounts made available to carry out this
p.000915: section may be used by the Secretary for administrative expenses of carrying out this section.
p.000915: SEC. 546. ø290ee–1¿ FIRST RESPONDER TRAINING.
p.000915: (a) PROGRAM AUTHORIZED.—The Secretary shall make grants to States, local governmental entities, and Indian
p.000915: tribes and tribal organizations (as defined in section 4 of the Indian Self-Determina- tion and Education Assistance
p.000915: Act) to allow first responders and members of other key community sectors to administer a drug or
p.000915: device approved or cleared under the Federal Food, Drug, and Cos-
p.000915: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: Sec. 546 PUBLIC HEALTH SERVICE ACT 916
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p.000915:
p.000915: metic Act for emergency treatment of known or suspected opioid overdose.
p.000915: (b) APPLICATION.—
p.000915: (1) IN GENERAL.—An entity seeking a grant under this sec- tion shall submit an application to the Secretary—
p.000915: (A) that meets the criteria under paragraph (2); and
p.000915: (B) at such time, in such manner, and accompanied by such information as the Secretary may require.
p.000915: (2) CRITERIA.—An entity, in submitting an application under paragraph (1), shall—
p.000915: (A) describe the evidence-based methodology and out- come measurements that will be used to evaluate the pro-
p.000915: gram funded with a grant under this section, and specifi- cally explain how such measurements will
p.000915: provide valid measures of the impact of the program;
p.000915: (B) describe how the program could be broadly rep- licated if demonstrated to be effective;
p.000915: (C) identify the governmental and community agencies with which the entity will coordinate to implement the
p.000915: program; and
p.000915: (D) describe how the entity will ensure that law en- forcement agencies will coordinate with
p.000915: their cor- responding State substance abuse and mental health agen- cies to identify protocols and resources
p.000915: that are available to overdose victims and families, including information on treatment and recovery
p.000915: resources.
p.000915: (c) USE OF FUNDS.—An entity shall use a grant received under this section to—
p.000915: (1) make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000915: treatment of known or suspected opioid overdose available to be carried and administered by first
p.000915: responders and members of other key community sectors;
p.000915: (2) train and provide resources for first responders and members of other key community sectors on
p.000915: carrying and ad- ministering a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose;
p.000915: (3) establish processes, protocols, and mechanisms for re- ferral to appropriate treatment, which may
p.000915: include an out- reach coordinator or team to connect individuals receiving opioid overdose reversal
p.000915: drugs to followup services; and
p.000915: (4) train and provide resources for first responders and members of other key community sectors on
p.000915: safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure
p.000915: to such drugs and respond appropriately when exposure occurs.
p.000915: (d) TECHNICAL ASSISTANCE GRANTS.—The Secretary shall make a grant for the purpose of providing technical
p.000915: assistance and train- ing on the use of a drug or device approved or cleared under the Federal Food,
p.000915: Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, mechanisms for referral to
p.000915: ap- propriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000915: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000917: PUBLIC HEALTH SERVICE ACT
p.000917: Sec. 547
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p.000917: (e) GEOGRAPHIC DISTRIBUTION.—In making grants under this section, the Secretary shall ensure that not less than
p.000917: 20 percent of grant funds are awarded to eligible entities that are not located in metropolitan statistical areas
p.000917: (as defined by the Office of Manage- ment and Budget). The Secretary shall take into account
p.000917: the unique needs of rural communities, including communities with an incidence of individuals with opioid use
p.000917: disorder that is above the national average and communities with a shortage of prevention and treatment
p.000917: services.
p.000917: (f) EVALUATION.—The Secretary shall conduct an evaluation of grants made under this section to determine—
p.000917: (1) the number of first responders and members of other key community sectors equipped with a drug or
p.000917: device ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000917: suspected opioid overdose;
p.000917: (2) the number of opioid and heroin overdoses reversed by first responders and members of other key community
p.000917: sectors receiving training and supplies of a drug or device approved or cleared under the Federal Food, Drug, and
p.000917: Cosmetic Act for emergency treatment of known or suspected opioid overdose, through a grant received under
p.000917: this section;
p.000917: (3) the number of responses to requests for services by the entity or subgrantee, to opioid and heroin overdose;
p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
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p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
p.000917: each of fis- cal years 2019 through 2023.
p.000917: SEC. 547A. ø290ee–2a¿ PEER SUPPORT TECHNICAL ASSISTANCE CEN- TER.
p.000917: (a) ESTABLISHMENT.—The Secretary, acting through the Assist- ant Secretary, shall establish or operate a
p.000917: National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this
p.000917: section as the ‘‘Center’’).
p.000917: (b) FUNCTIONS.—The Center established under subsection (a) shall provide technical assistance and support
p.000917: to recovery commu- nity organizations and peer support networks, including such as- sistance and support
p.000917: related to—
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: 919
p.000919: PUBLIC HEALTH SERVICE ACT
p.000919: Sec. 548
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p.000919: (1) training on identifying—
p.000919: (A) signs of substance use disorder;
p.000919: (B) resources to assist individuals with a substance use disorder, or resources for families of an individual
p.000919: with a substance use disorder; and
p.000919: (C) best practices for the delivery of recovery support services;
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p.000919: January 30, 2020
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p.000919: (2) PURPOSES.—A State receiving a grant under this sec- tion shall establish a comprehensive response
p.000919: plan to opioid abuse, which may include—
p.000919: (A) education efforts around opioid use, treatment, and addiction recovery, including education of residents,
p.000919: med- ical students, and physicians and other prescribers of schedule II, III, or IV controlled
p.000919: substances on relevant prescribing guidelines, the prescription drug monitoring program of the State
p.000919: described in subparagraph (B), and overdose prevention methods;
p.000919: (B) establishing, maintaining, or improving a com- prehensive prescription drug monitoring program to track
p.000919: dispensing of schedule II, III, or IV controlled substances, which may—
p.000919: (i) provide for data sharing with other States; and
p.000919: (ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled
p.000919: substances to access the prescription drug monitoring program of the State;
p.000919: (C) developing, implementing, or expanding prescrip- tion drug and opioid addiction treatment programs by—
p.000919: (i) expanding the availability of treatment for pre- scription drug and opioid addiction, including medica-
p.000919: tion-assisted treatment and behavioral health therapy, as appropriate;
p.000919: (ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug
p.000919: and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically ap-
p.000919: propriate; or
p.000919: (iii) developing, implementing, or expanding recov- ery support services and programs at high schools or
p.000919: institutions of higher education;
p.000919: (D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to
p.000919: prescription medications and opioids; and
p.000919: (E) advancing the education and awareness of the pub- lic, providers, patients, consumers, and other appropriate
p.000919: entities regarding the dangers of opioid abuse, safe dis- posal of prescription medications, and detection
p.000919: of early warning signs of opioid use disorders.
p.000919: (3) APPLICATION.—A State seeking a grant under this sec- tion shall submit to the Secretary an application in such
p.000919: form, and containing such information, as the Secretary may reason- ably require.
p.000919: (4) USE OF FUNDS.—A State that receives a grant under this section shall use the grant for the cost, including
p.000919: the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid
p.000919: abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established
p.000919: under paragraph (2).
p.000919: (5) PRIORITY CONSIDERATIONS.—In awarding grants under this section, the Secretary shall, as appropriate,
p.000919: give priority to a State that—
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p.000921: (A)(i) provides civil liability protection for first re- sponders, health professionals, and family members
p.000921: who have received appropriate training in administering a drug or device approved or cleared under the Federal
p.000921: Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (ii) submits to the Secretary a certification by the at- torney general of the State that the attorney general
p.000921: has—
p.000921: (I) reviewed any applicable civil liability protec- tion law to determine the applicability of the law with
p.000921: respect to first responders, health care professionals, family members, and other individuals who—
p.000921: (aa) have received appropriate training in ad- ministering a drug or device approved or cleared under the
p.000921: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (bb) may administer a drug or device ap- proved or cleared under the Federal Food, Drug, and
p.000921: Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (II) concluded that the law described in subclause
p.000921: (I) provides adequate civil liability protection applica- ble to such persons;
p.000921: (B) has a process for enrollment in services and bene- fits necessary by criminal justice agencies to initiate
p.000921: or continue treatment in the community, under which an in- dividual who is incarcerated may, while
p.000921: incarcerated, en- roll in services and benefits that are necessary for the indi- vidual to continue treatment upon
p.000921: release from incarcer- ation;
p.000921: (C) ensures the capability of data sharing with other States, where applicable, such as by making data
p.000921: available to a prescription monitoring hub;
p.000921: (D) ensures that data recorded in the prescription drug monitoring program database of the State are
p.000921: regu- larly updated, to the extent possible;
p.000921: (E) ensures that the prescription drug monitoring pro- gram of the State notifies prescribers and dispensers of
p.000921: schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients
p.000921: is sus- pected; and
p.000921: (F) has in effect one or more statutes or implements policies that maximize use of prescription drug
p.000921: monitoring programs by individuals authorized by the State to pre- scribe schedule II, III, or IV controlled
p.000921: substances.
p.000921: (6) EVALUATION.—In conducting an evaluation of the pro- gram under this section pursuant to section 701
p.000921: of the Com- prehensive Addiction and Recovery Act of 2016, with respect to a State, the Secretary shall report on
p.000921: State legislation or poli- cies related to maximizing the use of prescription drug moni- toring programs and
p.000921: the incidence of opioid use disorders and overdose deaths in such State.
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000921: Sec. 549 PUBLIC HEALTH SERVICE ACT 922
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p.000921: January 30, 2020
p.000921:
p.000921: (7) STATES WITH LOCAL PRESCRIPTION DRUG MONITORING PROGRAMS.—
p.000921: (A) IN GENERAL.—In the case of a State that does not have a prescription drug monitoring program, a county or
p.000921: other unit of local government within the State that has a prescription drug monitoring program shall be
p.000921: treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1).
p.000921: (B) PLAN FOR INTEROPERABILITY.—In submitting an application to the Secretary under paragraph (3), a county or
p.000921: other unit of local government shall submit a plan out- lining the methods such county or unit of local government
p.000921: shall use to ensure the capability of data sharing with other counties and units of local government
p.000921: within the state and with other States, as applicable.
p.000921: (c) AUTHORIZATION OF FUNDING.—For the purpose of carrying out this section, there are authorized to be
p.000921: appropriated $5,000,000 for each of fiscal years 2017 through 2021.
p.000921: SEC. 549. ø290ee–4¿ MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON COLLEGE CAMPUSES.
p.000921: (a) PURPOSE.—It is the purpose of this section to increase ac- cess to, and reduce the stigma associated
p.000921: with, mental health serv- ices to ensure that students at institutions of higher education have the support
p.000921: necessary to successfully complete their studies.
p.000921: (b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary, acting through the Assistant Secretary and in
p.000921: collaboration with the Director of the Centers for Disease Control and Prevention, shall convene an
p.000921: interagency, public-private sector working group to plan, establish, and begin coordinating and evaluating
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p.000923: January 30, 2020
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p.000923: designated housing entities that provide recovery housing services, as applicable;
p.000923: (F) individuals with a history of substance use dis- order; and
p.000923: (G) other stakeholders identified by the Secretary.
p.000923: (b) IDENTIFICATION OF FRAUDULENT RECOVERY HOUSING OPER-
p.000923: ATORS.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities described in paragraph (2),
p.000923: shall iden- tify or facilitate the development of common indicators that could be used to identify potentially
p.000923: fraudulent recovery hous- ing operators.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate, the individuals and entities specified in subsection (a)(2) and the Attorney General of
p.000923: the United States.
p.000923: (3) REQUIREMENTS.—
p.000923: (A) PRACTICES FOR IDENTIFICATION AND REPORTING.— In carrying out the activities described in paragraph
p.000923: (1), the Secretary shall consider how law enforcement, public and private payers, and the public can best
p.000923: identify and report fraudulent recovery housing operators.
p.000923: (B) FACTORS TO BE CONSIDERED.—In carrying out the activities described in paragraph (1), the Secretary
p.000923: shall identify or develop indicators, which may include indica- tors related to—
p.000923: (i) unusual billing practices;
p.000923: (ii) average lengths of stays;
p.000923: (iii) excessive levels of drug testing (in terms of cost or frequency); and
p.000923: (iv) unusually high levels of recidivism.
p.000923: (c) DISSEMINATION.—The Secretary shall, as appropriate, dis- seminate the best practices identified or
p.000923: developed under sub- section (a) and the common indicators identified or developed under subsection (b) to—
p.000923: (1) State agencies, which may include the provision of technical assistance to State agencies seeking to
p.000923: adopt or im- plement such best practices;
p.000923: (2) Indian tribes, tribal organizations, and tribally des- ignated housing entities;
p.000923: (3) the Attorney General of the United States;
p.000923: (4) the Secretary of Labor;
p.000923: (5) the Secretary of Housing and Urban Development;
p.000923: (6) State and local law enforcement agencies;
p.000923: (7) health insurance issuers;
p.000923: (8) recovery housing entities; and
p.000923: (9) the public.
p.000923: (d) REQUIREMENTS.—In carrying out the activities described in subsections (a) and (b), the Secretary, in
p.000923: consultation with appro- priate individuals and entities described in subsections (a)(2) and (b)(2), shall
p.000923: consider how recovery housing is able to support recov- ery and prevent relapse, recidivism, or overdose (including
p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: 925
p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
p.000925: Disorder Education for purposes of im- proving health professional training resources with respect to sub- stance
p.000925: use disorder prevention, treatment, and recovery.
p.000925: (b) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under subsection (a), an entity shall—
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p.000925: such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a
p.000925: single State for any one period.
p.000925: (d) APPLICATION.—
p.000925: (1) ELIGIBLE ENTITY.—An entity is eligible for a grant under this section if the entity offers treatment and
p.000925: other serv- ices for individuals with a substance use disorder.
p.000925: (2) SUBMISSION OF APPLICATION.—In order to be eligible for a grant under subsection (a), an entity shall
p.000925: submit an applica- tion to the Secretary at such time and in such manner as the Secretary may require. Such
p.000925: application shall include—
p.000925: (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activi-
p.000925: ties described in subsection (g); and
p.000925: (B) such other information as the Secretary may re- quire.
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: 927
p.000927: PUBLIC HEALTH SERVICE ACT
p.000927: Sec. 552
p.000927:
p.000927: (e) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to eligible entities—
p.000927: (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national
p.000927: overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or
p.000927: (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education
p.000927: Assistance Act) with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate,
p.000927: as determined through appro- priate mechanisms determined by the Secretary in consultation with Indian Tribes.
p.000927: (f) PREFERENCE.—In awarding grants under subsection (a), the Secretary may give preference to eligible entities
p.000927: utilizing tech- nology-enabled collaborative learning and capacity building models, including such models as defined
p.000927: in section 2 of the Expanding Ca- pacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to
p.000927: conduct the activities described in this section.
p.000927: (g) CENTER ACTIVITIES.—Each Center shall, at a minimum, carry out the following activities directly,
p.000927: through referral, or through contractual arrangements, which may include carrying out such activities through
p.000927: technology-enabled collaborative learning and capacity building models described in subsection (f):
p.000927: (1) TREATMENT AND RECOVERY SERVICES.—Each Center shall—
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p.000927: (A) Ensure that intake, evaluations, and periodic pa- tient assessments meet the individualized clinical needs
p.000927: of patients, including by reviewing patient placement in treatment settings to support meaningful recovery.
p.000927: (B) Provide the full continuum of treatment services, including—
p.000927: (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all bio- logical
p.000927: products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant
p.000927: to Federal and State law;
p.000927: (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and
p.000927: readiness for and entry into treatment;
p.000927: (iii) counseling provided by a program counselor or other certified professional who is licensed and quali- fied
p.000927: by education, training, or experience to assess the psychological and sociological background of patients, to
p.000927: contribute to the appropriate treatment plan for the patient, and to monitor patient progress;
p.000927: (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders;
p.000927: (v) testing, as appropriate, for infections com- monly associated with illicit drug use;
p.000927: (vi) residential rehabilitation, and outpatient and intensive outpatient programs;
p.000927: (vii) recovery housing;
p.000927: (viii) community-based and peer recovery support services;
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
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p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
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p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
p.000939:
p.000939: January 30, 2020
p.000939: 19 There is another part G in this title, which also begins with a section 581. See page 677. That
p.000939: part G relates to services provided through religious organizations.
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000941: member, or others; and
p.000941: (2) the restraints or seclusion are imposed only upon the written order of a physician, or other licensed
p.000941: practitioner per- mitted by the State and the facility to order such restraint or seclusion, that specifies
p.000941: the duration and circumstances under which the restraints are to be used (except in emergency cir- cumstances
p.000941: specified by the Secretary until such an order could reasonably be obtained).
p.000941: (c) CURRENT LAW.—This part shall not be construed to affect or impede any Federal or State law or
p.000941: regulations that provide greater protections than this part regarding seclusion and re- straint.
p.000941: (d) DEFINITIONS.—In this section:
p.000941: (1) RESTRAINTS.—The term ‘‘restraints’’ means—
p.000941: (A) any physical restraint that is a mechanical or per- sonal restriction that immobilizes or reduces the ability of an
p.000941: individual to move his or her arms, legs, or head freely, not including devices, such as orthopedically prescribed de-
p.000941: vices, surgical dressings or bandages, protective helmets, or any other methods that involves the physical
p.000941: holding of a resident for the purpose of conducting routine physical examinations or tests or to protect
p.000941: the resident from fall- ing out of bed or to permit the resident to participate in activities without the
p.000941: risk of physical harm to the resident (such term does not include a physical escort); and
p.000941: (B) a drug or medication that is used as a restraint to control behavior or restrict the resident’s freedom of move-
p.000941: ment that is not a standard treatment for the resident’s medical or psychiatric condition.
p.000941: (2) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000941: term does not include a time out.
p.000941: (3) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000941: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000941: (4) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000941: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000941: for the purpose of calming. Time out is not seclusion.
p.000941: SEC. 592. ø290ii–1¿ REPORTING REQUIREMENT.
p.000941: (a) IN GENERAL.—Each facility to which the Protection and Ad- vocacy for Mentally Ill Individuals Act of 1986 20
p.000941: applies shall no- tify the appropriate agency, as determined by the Secretary, of each death that occurs
p.000941: at each such facility while a patient is re- strained or in seclusion, of each death occurring within
p.000941: 24 hours after the patient has been removed from restraints and seclusion,
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p.000945: 945
p.000945: PUBLIC HEALTH SERVICE ACT
p.000945: Sec. 595
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p.000945: (i) ensure that a supervisory or senior staff person with training in restraint and seclusion who is com-
p.000945: petent to conduct a face-to-face assessment (as defined in regulations promulgated by the Secretary), will as-
p.000945: sess the mental and physical well-being of the child or youth being restrained or secluded and assure that the
p.000945: restraint or seclusion is being done in a safe manner;
p.000945: (ii) ensure that the assessment required under clause (i) take place as soon as practicable, but in no
p.000945: case later than 1 hour after the initiation of the re- straint or seclusion; and
p.000945: (iii) ensure that the supervisory or senior staff person continues to monitor the situation for the dura- tion
p.000945: of the restraint and seclusion.
p.000945: (3) LIMITATIONS.—
p.000945: (A) IN GENERAL.—The use of a drug or medication that is used as a restraint to control behavior or restrict
p.000945: the resident’s freedom of movement that is not a standard treatment for the resident’s medical or
p.000945: psychiatric condi- tion in nonmedical community-based facilities for children and youth described in subsection
p.000945: (a)(1) is prohibited.
p.000945: (B) PROHIBITION.—The use of mechanical restraints in non-medical, community-based facilities for children and
p.000945: youth described in subsection (a)(1) is prohibited.
p.000945: (C) LIMITATION.—A non-medical, community-based fa- cility for children and youth described in subsection
p.000945: (a)(1) may only use seclusion when a staff member is continu- ously face-to-face monitoring the resident and
p.000945: when strong licensing or accreditation and internal controls are in place.
p.000945: (c) RULE OF CONSTRUCTION.—
p.000945: (1) IN GENERAL.—Nothing in this section shall be con- strued as prohibiting the use of restraints for
p.000945: medical immo- bilization, adaptive support, or medical protection.
p.000945: (2) CURRENT LAW.—This part shall not be construed to af- fect or impede any Federal or State law or
p.000945: regulations that provide greater protections than this part regarding seclusion and restraint.
p.000945: (d) DEFINITIONS.—In this section:
p.000945: (1) MECHANICAL RESTRAINT.—The term ‘‘mechanical re- straint’’ means the use of devices as a means of
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p.000949: shall be subject to the same regulations as other recipients of awards of Federal financial assistance to
p.000949: account, in accordance with generally accepted auditing principles, for the use of the funds provided under such
p.000949: awards.
p.000949: (2) LIMITED AUDIT.—With respect to the award involved, a religious organization that is a program participant
p.000949: shall seg- regate Federal amounts provided under award into a separate account from non-Federal funds. Only the award
p.000949: funds shall be subject to audit by the government.
p.000949: (h) COMPLIANCE.—With respect to compliance with this section by an agency, a religious organization may obtain
p.000949: judicial review of agency action in accordance with chapter 7 of title 5, United States Code.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000949: Sec. 583 PUBLIC HEALTH SERVICE ACT 950
p.000949:
p.000949: SEC. 583. ø290kk–2¿ LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
p.000949: No funds provided under a designated program shall be ex- pended for sectarian worship, instruction, or
p.000949: proselytization.
p.000949: SEC. 584. ø290kk–3¿ EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG TREATMENT PROGRAMS.
p.000949: (a) FINDINGS.—The Congress finds that—
p.000949: (1) establishing unduly rigid or uniform educational quali- fication for counselors and other personnel in drug
p.000949: treatment programs may undermine the effectiveness of such programs; and
p.000949: (2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug
p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
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p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
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p.001069: (c) ELIGIBLE LOANS.—The loans eligible for repayment under this section are each of the following:
p.001069: (1) Any loan for education or training for a substance use disorder treatment employment.
p.001069: (2) Any loan under part E of title VIII (relating to nursing student loans).
p.001069: (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or
p.001069: Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).
p.001069: (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.
p.001069: (5) Any other Federal loan as determined appropriate by the Secretary.
p.001069: (d) REQUIREMENTS OF SERVICE.—Any individual receiving pay- ments under this program as required by an agreement under
p.001069: sub- section (a) shall agree to an annual commitment to full-time em- ployment, with no more than 1
p.001069: year passing between any 2 years of covered employment, in substance use disorder treatment em- ployment
p.001069: in the United States in—
p.001069: (1) a Mental Health Professional Shortage Area, as des- ignated under section 332; or
p.001069: (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per
p.001069: 100,000 people over the past 3 years for which official data is available from the State, is higher than the
p.001069: most recent available na-
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001069:
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p.001069: Sec. 781 PUBLIC HEALTH SERVICE ACT 1070
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p.001069:
p.001069: tional average overdose death rate per 100,000 people, as re- ported by the Centers for Disease Control and
p.001069: Prevention.
p.001069: (e) INELIGIBILITY FOR DOUBLE BENEFITS.—No borrower may, for the same service, receive a reduction of
p.001069: loan obligations or a loan repayment under both—
p.001069: (1) this section; and
p.001069: (2) any Federally supported loan forgiveness program, in- cluding under section 338B, 338I, or 846 of this Act,
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p.001123: 1123
p.001123: PUBLIC HEALTH SERVICE ACT
p.001123: Sec. 916
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p.001123: January 30, 2020
p.001123: retary for Health, the Administrator of the Centers for Medi- care & Medicaid Services, the Director of
p.001123: the National Insti- tutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested
p.001123: Federal department or agency, and shall seek input, where appropriate, from professional so- cieties and
p.001123: other private and public entities.
p.001123: (3) METHODOLOGY.—The Director shall, in developing the methods used under paragraph (1), consider—
p.001123: (A) safety, efficacy, and effectiveness;
p.001123: (B) legal, social, and ethical implications;
p.001123: (C) costs, benefits, and cost-effectiveness;
p.001123: (D) comparisons to alternate health care practices and technologies; and
p.001123: (E) requirements of Food and Drug Administration ap- proval to avoid duplication.
p.001123: (c) SPECIFIC ASSESSMENTS.—
p.001123: (1) IN GENERAL.—The Director shall conduct or support specific assessments of health care technologies and
p.001123: practices.
p.001123: (2) REQUESTS FOR ASSESSMENTS.—The Director is author- ized to conduct or support assessments, on a
p.001123: reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the
p.001123: Department of Veterans Affairs, the Office of Personnel Management, and other public or pri- vate entities.
p.001123: (3) GRANTS AND CONTRACTS.—In addition to conducting as- sessments, the Director may make grants to, or enter
p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
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p.001127: be con- strued to prohibit) one or more of the following disclosures:
p.001127: (A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after
p.001127: a court makes an in camera determination that such patient safe- ty work product contains evidence of a
p.001127: criminal act and that such patient safety work product is material to the proceeding and not reasonably
p.001127: available from any other source.
p.001127: (B) Disclosure of patient safety work product to the ex- tent required to carry out subsection (f)(4)(A).
p.001127: (C) Disclosure of identifiable patient safety work prod- uct if authorized by each provider identified in such
p.001127: work product.
p.001127: (2) EXCEPTIONS FROM CONFIDENTIALITY.—Subsection (b) shall not apply to (and shall not be construed
p.001127: to prohibit) one or more of the following disclosures:
p.001127: (A) Disclosure of patient safety work product to carry out patient safety activities.
p.001127: (B) Disclosure of nonidentifiable patient safety work product.
p.001127: (C) Disclosure of patient safety work product to grant- ees, contractors, or other entities carrying out
p.001127: research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by
p.001127: rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of
p.001127: protected health information would be allowed for such purpose under the HIPAA con- fidentiality
p.001127: regulations.
p.001127: (D) Disclosure by a provider to the Food and Drug Ad- ministration with respect to a product or activity regulated by
p.001127: the Food and Drug Administration.
p.001127: (E) Voluntary disclosure of patient safety work prod- uct by a provider to an accrediting body that accredits
p.001127: that provider.
p.001127: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001129: 1129
p.001129: PUBLIC HEALTH SERVICE ACT
p.001129: Sec. 922
p.001129:
p.001129: (F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations
p.001129: and are consistent with the goals of this part.
p.001129: (G) Disclosure of patient safety work product to law enforcement authorities relating to the commission
p.001129: of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes,
p.001129: reasonably under the circumstances, that the patient safety work product that is disclosed is necessary
p.001129: for criminal law en- forcement purposes.
p.001129: (H) With respect to a person other than a patient safe- ty organization, the disclosure of patient safety work prod-
p.001129: uct that does not include materials that—
p.001129: (i) assess the quality of care of an identifiable pro- vider; or
p.001129: (ii) describe or pertain to one or more actions or failures to act by an identifiable provider.
p.001129: (3) EXCEPTION FROM PRIVILEGE.—Subsection (a) shall not apply to (and shall not be construed to prohibit)
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p.001131: assert the privilege described in subsection (a) unless before the time of the assertion, the entity or, in the
p.001131: case of and with respect to an agency, the State has consented to be subject to an action described in
p.001131: subparagraph (A), and that con- sent has remained in effect.
p.001131: (g) RULE OF CONSTRUCTION.—Nothing in this section shall be construed—
p.001131: (1) to limit the application of other Federal, State, or local laws that provide greater privilege or
p.001131: confidentiality protec- tions than the privilege and confidentiality protections pro- vided for in this
p.001131: section;
p.001131: (2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to
p.001131: information that is not privi- leged or confidential under this section;
p.001131: (3) except as provided in subsection (i), to alter or affect the implementation of any provision of the
p.001131: HIPAA confiden- tiality regulations or section 1176 of the Social Security Act (or regulations promulgated under such
p.001131: section);
p.001131: (4) to limit the authority of any provider, patient safety or- ganization, or other entity to enter into a
p.001131: contract requiring greater confidentiality or delegating authority to make a disclo- sure or use in accordance with
p.001131: this section;
p.001131: (5) as preempting or otherwise affecting any State law re- quiring a provider to report information that is not
p.001131: patient safety work product; or
p.001131: (6) to limit, alter, or affect any requirement for reporting to the Food and Drug Administration
p.001131: information regarding the safety of a product or activity regulated by the Food and Drug Administration.
p.001131: (h) CLARIFICATION.—Nothing in this part prohibits any person from conducting additional analysis for any
p.001131: purpose regardless of whether such additional analysis involves issues identical to or similar to those for
p.001131: which information was reported to or assessed by a patient safety organization or a patient safety evaluation sys- tem.
p.001131: (i) CLARIFICATION OF APPLICATION OF HIPAA CONFIDENTIALITY REGULATIONS TO PATIENT SAFETY
p.001131: ORGANIZATIONS.—For purposes of applying the HIPAA confidentiality regulations—
p.001131: (1) patient safety organizations shall be treated as busi- ness associates; and
p.001131: (2) patient safety activities of such organizations in rela- tion to a provider are deemed to be health care
p.001131: operations (as defined in such regulations) of the provider.
p.001131: (j) REPORTS ON STRATEGIES TO IMPROVE PATIENT SAFETY.—
p.001131: (1) DRAFT REPORT.—Not later than the date that is 18 months after any network of patient safety
p.001131: databases is oper- ational, the Secretary, in consultation with the Director, shall prepare a draft report on
p.001131: effective strategies for reducing med- ical errors and increasing patient safety. The draft report shall include any
p.001131: measure determined appropriate by the Secretary to encourage the appropriate use of such strategies,
p.001131: including use in any federally funded programs. The Secretary shall
p.001131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001145: or in collaboration with primary care extension programs es- tablished in section 399V–1;
p.001145: (4) submit a plan for meeting the requirements under sub- section (c); and
p.001145: (5) submit to the Secretary such other information as the Secretary may require.
p.001145: (c) MTM SERVICES TO TARGETED INDIVIDUALS.—The MTM services provided with the assistance of a grant or
p.001145: contract award- ed under subsection (a) shall, as allowed by State law including ap- plicable collaborative pharmacy
p.001145: practice agreements, include—
p.001145: (1) performing or obtaining necessary assessments of the health and functional status of each patient
p.001145: receiving such MTM services;
p.001145: (2) formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber
p.001145: and the pa- tient or caregiver or authorized representative of the patient;
p.001145: (3) selecting, initiating, modifying, recommending changes to, or administering medication therapy;
p.001145: (4) monitoring, which may include access to, ordering, or performing laboratory assessments, and
p.001145: evaluating the re- sponse of the patient to therapy, including safety and effective- ness;
p.001145: (5) performing an initial comprehensive medication review to identify, resolve, and prevent medication-related
p.001145: problems, including adverse drug events, quarterly targeted medication reviews for ongoing monitoring, and
p.001145: additional followup inter- ventions on a schedule developed collaboratively with the pre- scriber;
p.001145: (6) documenting the care delivered and communicating es- sential information about such care, including a
p.001145: summary of the medication review, and the recommendations of the phar- macist to other appropriate health care
p.001145: providers of the patient in a timely fashion;
p.001145: (7) providing education and training designed to enhance the understanding and appropriate use of the
p.001145: medications by the patient, caregiver, and other authorized representative;
p.001145: (8) providing information, support services, and resources and strategies designed to enhance patient
p.001145: adherence with therapeutic regimens;
p.001145: (9) coordinating and integrating MTM services within the broader health care management services provided
p.001145: to the pa- tient; and
p.001145: (10) such other patient care services allowed under phar- macist scopes of practice in use in other Federal
p.001145: programs that have implemented MTM services.
p.001145: (d) TARGETED INDIVIDUALS.—MTM services provided by li- censed pharmacists under a grant or contract
p.001145: awarded under sub- section (a) shall be offered to targeted individuals who—
p.001145: (1) take 4 or more prescribed medications (including over- the-counter medications and dietary supplements);
p.001145: (2) take any ‘‘high risk’’ medications;
p.001145: (3) have 2 or more chronic diseases, as identified by the Secretary; or
p.001145: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001151: concerned with, or affected by, activities under this title and under section 1142 of the Social Security
p.001151: Act. Of such members—
p.001151: (A) three shall be individuals distinguished in the con- duct of research, demonstration projects, and
p.001151: evaluations with respect to health care;
p.001151: (B) three shall be individuals distinguished in the fields of health care quality research or health
p.001151: care im- provement;
p.001151: (C) three shall be individuals distinguished in the practice of medicine of which at least one shall be
p.001151: a pri- mary care practitioner;
p.001151: (D) three shall be individuals distinguished in the other health professions;
p.001151: (E) three shall be individuals either representing the private health care sector, including health plans,
p.001151: pro- viders, and purchasers or individuals distinguished as ad- ministrators of health care delivery systems;
p.001151: (F) three shall be individuals distinguished in the fields of health care economics, information systems,
p.001151: law, ethics, business, or public policy; and
p.001151: (G) three shall be individuals representing the inter- ests of patients and consumers of health care.
p.001151: (3) EX OFFICIO MEMBERS.—The Secretary shall designate as ex officio members of the Advisory Council—
p.001151: (A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Cen-
p.001151: ters for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Com-
p.001151: missioner of the Food and Drug Administration, the Direc- tor of the Office of Personnel Management, the
p.001151: Assistant Secretary of Defense (Health Affairs), and the Under Sec- retary for Health of the Department
p.001151: of Veterans Affairs; and
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p.001151: (B) such other Federal officials as the Secretary may consider appropriate.
p.001151: (d) TERMS.—
p.001151: (1) IN GENERAL.—Members of the Advisory Council ap- pointed under subsection (c)(2) shall serve for a
p.001151: term of 3 years.
p.001151: (2) STAGGERED TERMS.—To ensure the staggered rotation of one-third of the members of the Advisory Council
p.001151: each year, the Secretary is authorized to appoint the initial members of the Advisory Council for terms of 1,
p.001151: 2, or 3 years.
p.001151: (3) SERVICE BEYOND TERM.—A member of the Council ap- pointed under subsection (c)(2) may continue to serve
p.001151: after the expiration of the term of the members until a successor is ap- pointed.
p.001151: (e) VACANCIES.—If a member of the Advisory Council appointed under subsection (c)(2) does not serve the full
p.001151: term applicable under subsection (d), the individual appointed to fill the resulting vacancy shall be
p.001151: appointed for the remainder of the term of the predecessor of the individual.
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p.001171: received by the Committee;
p.001171: (6) develop a model decision-matrix for newborn screening expansion, including an evaluation of the
p.001171: potential public health impact, including the cost of such expansion, and peri- odically update the
p.001171: recommended uniform screening panel, as appropriate, based on such decision-matrix;
p.001171: (7) consider ways to ensure that all States attain the ca- pacity to screen for the conditions
p.001171: described in paragraph (3), and include in such consideration the results of grant funding under section
p.001171: 1109; and
p.001171: (8) provide such recommendations, advice or information as may be necessary to enhance, expand or improve the
p.001171: ability of the Secretary to reduce the mortality or morbidity from heri- table disorders, which may include
p.001171: recommendations, advice, or information dealing with—
p.001171: (A) follow-up activities, including those necessary to achieve best practices in rapid diagnosis and
p.001171: appropriate treatment in the short-term, and those that ascertain long- term case management outcomes and appropriate
p.001171: access to related services;
p.001171: (B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis,
p.001171: screen- ing, follow-up, and treatment activities;
p.001171: (C) diagnostic and other technology used in screening;
p.001171: (D) the availability and reporting of testing for condi- tions for which there is no existing treatment,
p.001171: including information on cost and incidence;
p.001171: (E) conditions not included in the recommended uni- form screening panel that are treatable with Food
p.001171: and Drug Administration-approved products or other safe and effective treatments, as determined by
p.001171: scientific evidence and peer review;
p.001171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001171: Sec. 1111 PUBLIC HEALTH SERVICE ACT 1172
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p.001171: (F) minimum standards and related policies and proce- dures used by State newborn screening programs, such as language
p.001171: and terminology used by State newborn screen- ing programs to include standardization of case definitions and
p.001171: names of disorders for which newborn screening tests are performed;
p.001171: (G) quality assurance, oversight, and evaluation of State newborn screening programs, including
p.001171: ensuring that tests and technologies used by each State meet estab- lished standards for detecting and
p.001171: reporting positive screening results;
p.001171: (H) public and provider awareness and education;
p.001171: (I) the cost and effectiveness of newborn screening and medical evaluation systems and intervention programs
p.001171: conducted by State-based programs;
p.001171: (J) identification of the causes of, public health im- pacts of, and risk factors for heritable disorders;
p.001171: (K) coordination of surveillance activities, including standardized data collection and reporting,
p.001171: harmonization of laboratory definitions for heritable disorders and testing results, and confirmatory testing and
p.001171: verification of posi- tive results, in order to assess and enhance monitoring of newborn diseases; and
p.001171: (L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable
p.001171: disorders in newborns in order to ensure rapid diagnosis and fol- lowup.
p.001171: (c) MEMBERSHIP.—
p.001171: (1) IN GENERAL.—The Secretary shall appoint not to exceed
p.001171: 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001171: total member- ship of the Advisory Committee is an odd number.
p.001171: (2) REQUIRED MEMBERS.—The Secretary shall appoint to the Advisory Committee under paragraph (1)—
p.001171: (A) the Administrator of the Health Resources and Services Administration;
p.001171: (B) the Director of the Centers for Disease Control and Prevention;
p.001171: (C) the Director of the National Institutes of Health;
p.001171: (D) the Director of the Agency for Healthcare Research and Quality;
p.001171: (E) the Commissioner of the Food and Drug Adminis- tration;
p.001171: (F) medical, technical, or scientific professionals with special expertise in heritable disorders, or in
p.001171: providing screening, counseling, testing or specialty services for newborns and children at risk for
p.001171: heritable disorders;
p.001171: (G) individuals with expertise in ethics and infectious diseases who have worked and published material
p.001171: in the area of newborn screening;
p.001171: (H) members of the public having special expertise about or concern with heritable disorders; and
p.001171: (I) representatives from such Federal agencies, public health constituencies, and medical professional societies
p.001171: as
p.001171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001173: PUBLIC HEALTH SERVICE ACT
p.001173: Sec. 1111
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p.001191:
p.001191: SEC. 1232. ø300d–32¿ FUNDING.
p.001191: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out parts A and B, subject to subsections (b)
p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
p.001191: appropriated is greater than
p.001191: $1,000,000, 50 percent of such appropriation shall be made avail- able for the purpose of carrying out part A
p.001191: and 50 percent shall be made available for the purpose of carrying out part B.
p.001191: (c) ALLOCATION OF PART A FUNDS.—Of the amounts appro- priated under subsection (a) for a fiscal year to carry
p.001191: out part A—
p.001191: (1) 10 percent of such amounts for such year shall be allo- cated for administrative purposes; and
p.001191: (2) 10 percent of such amounts for such year shall be allo- cated for the purpose of carrying out section 1202.
p.001191: (d) AUTHORITY.—For the purpose of carrying out parts A through C, beginning on the date of enactment of
p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
p.001191: (3) to provide emergency relief to ensure the continued and future availability of trauma services.
p.001191: (b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS.—
p.001191: (1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—Except as
p.001191: pro- vided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a)
...

p.001269: others to support) such activities as may be required to make information respecting health information and
p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
p.001271: dis- eases; and shall be designed to reach populations of different languages and of different social and
p.001271: economic backgrounds.
p.001271: (2) Securing the cooperation of the communication media, providers of health care, schools, and others in
p.001271: activities de- signed to promote and encourage the use of health maintaining information and behavior.
p.001271: (3) The study of health information and promotion in ad- vertising and the making to concerned Federal
p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others of information for use by the public respecting health in- surance policies and prepaid health plans,
p.001271: including informa- tion on the benefits provided by the various types of such poli- cies and plans, the premium
p.001271: charges for such policies and plans, exclusions from coverage or eligibility for coverage, cost sharing
p.001271: requirements, and the ratio of the amounts paid as benefits to the amounts received as premiums and information
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p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
p.001277: Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administra-
p.001277: tion, and the Centers for Medicare & Medicaid Services.
p.001277: (c) DIRECTOR; APPOINTMENT.—Each Office of Minority Health established in an agency listed in subsection (a) shall
p.001277: be headed by a director, with documented experience and expertise in minority health services research and
p.001277: health disparities elimination.
p.001277: (d) REFERENCES.—Except as otherwise specified, any reference in Federal law to an Office of Minority Health (in the
p.001277: Department of Health and Human Services) is deemed to be a reference to the Office of Minority Health in the Office of
p.001277: the Secretary.
p.001277: (e) FUNDING.—
p.001277: (1) ALLOCATIONS.—Of the amounts appropriated for a spec- ified agency for a fiscal year, the Secretary must designate
p.001277: an appropriate amount of funds for the purpose of carrying out ac- tivities under this section through the minority
p.001277: health office of the agency. In reserving an amount under the preceding sen- tence for a minority health
p.001277: office for a fiscal year, the Sec- retary shall reduce, by substantially the same percentage, the amount
p.001277: that otherwise would be available for each of the pro- grams of the designated agency involved.
p.001277: (2) AVAILABILITY OF FUNDS FOR STAFFING.—The purposes for which amounts made available under paragraph may be ex-
p.001277: pended by a minority health office include the costs of employ- ing staff for such office.
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p.001279: (3) with respect to which there has been insufficient clin- ical research involving adolescents as
p.001279: subjects or insufficient clinical data on adolescents.
p.001279: BIENNIAL REPORT REGARDING NUTRITION AND HEALTH
p.001279: SEC. 1709. ø300u–8¿ (a) BIENNIAL REPORT.—The Secretary
p.001279: shall require the Surgeon General of the Public Health Service to prepare biennial reports on the
p.001279: relationship between nutrition and health. Such reports may, with respect to such relationship, include any
p.001279: recommendations of the Secretary and the Surgeon General.
p.001279: (b) SUBMISSION TO CONGRESS.—The Secretary shall ensure that, not later than February 1 of 1995 and
p.001279: of every second year thereafter, a report under subsection (a) is submitted to the Com- mittee on
p.001279: Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the
p.001279: Senate.
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p.001279: January 30, 2020
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p.001279: EDUCATION REGARDING DES
p.001279: SEC. 1710. ø300u–9¿ (a) IN GENERAL.—The Secretary, acting through the heads of the appropriate agencies of the
p.001279: Public Health Service, shall carry out a national program for the education of health professionals and
p.001279: the public with respect to the drug diethylstilbestrol (commonly known as DES). To the extent
p.001279: appro- priate, such national program shall use methodologies developed through the education demonstration
p.001279: program carried out under section 403C. In developing and carrying out the national program, the Secretary shall
p.001279: consult closely with representatives of nonprofit private entities that represent individuals who have been
p.001279: exposed to DES and that have expertise in community-based information campaigns for the public and for health
p.001279: care providers. The imple- mentation of the national program shall begin during fiscal year 1999.
p.001279: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001279: to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The
p.001279: authorization of appropriations established in the preceding sentence is in addition to any other authorization of
p.001279: appropriation that is available for such purpose.
p.001279: SEC. 1711. ø300u–16¿ ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION DASHBOARD.
p.001279: (a) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Secretary of Health
p.001279: and Human Services shall, in consultation with the Director of National Drug Control Policy, establish
p.001279: and periodically update, on the Internet website of the Department of Health and Human Services, a public
p.001279: information dashboard that—
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
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p.001279:
p.001279: Sec. 1801 PUBLIC HEALTH SERVICE ACT 1280
p.001279:
p.001279: (1) provides links to information on programs within the Department of Health and Human Services related
p.001279: to the re- duction of opioid and other substance use disorders;
p.001279: (2) provides access, to the extent practicable and appro- priate, to publicly available data, which may include
p.001279: data from agencies within the Department of Health and Human Serv- ices and—
p.001279: (A) other Federal agencies;
p.001279: (B) State, local, and Tribal governments;
p.001279: (C) nonprofit organizations;
p.001279: (D) law enforcement;
p.001279: (E) medical experts;
p.001279: (F) public health educators; and
p.001279: (G) research institutions regarding prevention, treat- ment, recovery, and other services for opioid and
p.001279: other substance use disorders;
p.001279: (3) provides data on substance use disorder prevention and treatment strategies in different regions of and
p.001279: populations in the United States;
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p.001305: Commerce; divided by
p.001305: (II) the factor determined under paragraph (8) for the District.
p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
p.001305: in clause (ii) for the District of Columbia.
p.001305: (7) DETERMINATION OF TERM ‘‘P%’’.—For purposes of para- graph (4), the term ‘‘P%’’ means the percentage
p.001305: constituted by the ratio of the term ‘‘P’’ determined under paragraph (5) for the State involved to the sum
p.001305: of the respective terms ‘‘P’’ deter- mined for the States.
p.001305: (8) DETERMINATION OF CERTAIN FACTOR.—
p.001305: (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to
p.001305: adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under
p.001305: each of sub- paragraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist
p.001305: between the State and other States in the costs of providing comprehensive community mental health services to
p.001305: adults with a serious mental ill- ness and to children with a serious emotional disturbance.
p.001305: (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year
p.001305: in- volved shall be determined according to the methodology described in the report entitled ‘‘Adjusting
p.001305: the Alcohol, Drug Abuse and Mental Health Services Block Grant Allo- cations for Poverty Populations and Cost of
p.001305: Service’’, dated March 30, 1990, and prepared by Health Economics Re- search, a corporation, pursuant to a
p.001305: contract with the Na- tional Institute on Drug Abuse.
p.001305: (C) The factor determined under this paragraph for the State involved may not for any fiscal year be
p.001305: greater than 1.1 or less than 0.9.
p.001305: (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General,
p.001305: shall in accordance with this section make a determination for each State of the factor that is to be in effect
p.001305: for the State under this paragraph. The factor so determined shall re- main in effect through fiscal year 1994,
p.001305: and shall be recal- culated every third fiscal year thereafter.
p.001305: (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the
p.001305: Federal Register, periodically make such refinements in the meth- odology referred to in subparagraph (B) as are
p.001305: consistent with the purpose described in subparagraph (A).
p.001305: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001307: PUBLIC HEALTH SERVICE ACT
p.001307: Sec. 1919
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p.001309: January 30, 2020
p.001309:
p.001309: graph, as indicated by a comparison of the number of such women seeking the services with the availability in
p.001309: the State of the services.
p.001309: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001309: 120 days after the date on which the request is made.
p.001309: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001309: in- volved.
p.001309: (3) CHILDCARE AND PRENATAL CARE.—A funding agreement for a grant under section 1921 for a State is that
p.001309: each entity providing treatment services with amounts reserved under paragraph (1) by the State will,
p.001309: directly or through arrange- ments with other public or nonprofit private entities, make available
p.001309: prenatal care to women receiving such services and, while the women are receiving the services, childcare.
p.001309: SEC. 1923. ø300x–23¿ INTRAVENOUS SUBSTANCE ABUSE.
p.001309: (a) CAPACITY OF TREATMENT PROGRAMS.—
p.001309: (1) NOTIFICATION OF REACHING CAPACITY.—A funding agreement for a grant under section 1921 is that the
p.001309: State in- volved will, in the case of programs of treatment for intra- venous drug abuse, require that
p.001309: any such program receiving amounts from the grant, upon reaching 90 percent of its capac- ity to admit
p.001309: individuals to the program, provide to the State a notification of such fact.
p.001309: (2) PROVISION OF TREATMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001309: will, with respect to notifications under paragraph (1), ensure that each individual who requests and is
p.001309: in need of treatment for intra- venous drug abuse is admitted to a program of such treatment not later than—
p.001309: (A) 14 days after making the request for admission to such a program; or
p.001309: (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on
p.001309: the date of such request and if interim services are made available to the individual not later than 48
p.001309: hours after such request.
p.001309: (b) OUTREACH TO PERSONS WHO INJECT DRUGS.—A funding agreement for a grant under section 1921 is
p.001309: that the State in- volved, in providing amounts from the grant to any entity for treat- ment services for persons
p.001309: who inject drugs, will require the entity to carry out activities to encourage individuals in need of
p.001309: such treatment to undergo treatment.
p.001309: SEC. 1924. ø300x–24¿ REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN IMMUNODEFICIENCY VIRUS.
p.001309: (a) TUBERCULOSIS.—
p.001309: (1) IN GENERAL.—A funding agreement for a grant under section 1921 is that the State involved will
p.001309: require that any entity receiving amounts from the grant for operating a pro- gram of treatment for
p.001309: substance use disorders—
p.001309: (A) will, directly or through arrangements with other public or nonprofit private entities, routinely make
p.001309: avail-
p.001309: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001309:
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p.001313: agreements re- quired in this section, subject to paragraph (2).
p.001313: (2) LIMITATION.—A funding agreement for a grant under section 1921 for a State is that the grant will not be
p.001313: expended to make payment for any service provided for purposes of com- pliance with this section to the extent
p.001313: that payment has been made, or can reasonably be expected to be made, with respect to such service—
p.001313: (A) under any State compensation program, under any insurance policy, or under any Federal or State health
p.001313: benefits program (including the program established in title XVIII of the Social Security Act and the
p.001313: program es- tablished in title XIX of such Act); or
p.001313: (B) by an entity that provides health services on a pre- paid basis.
p.001313: (d) APPLICABILITY OF CERTAIN PROVISION.—Section 1931 ap- plies to this section (and to each other
p.001313: provision of this subpart).
p.001313: SEC. 1925. ø300x–25¿ GROUP HOMES FOR PERSONS IN RECOVERY FROM SUBSTANCE USE DISORDERS.
p.001313: (a) STATE REVOLVING FUNDS FOR ESTABLISHMENT OF HOMES.— A State, using funds available under section 1921,
p.001313: may establish and maintain the ongoing operation of a revolving fund in accord- ance with this section to
p.001313: support group homes for persons in recov- ery from substance use disorders as follows:
p.001313: (1) The purpose of the fund is to make loans for the costs of establishing programs for the provision of housing in
p.001313: which individuals recovering from alcohol or drug abuse may reside in groups of not less than 6
p.001313: individuals. The fund is estab- lished directly by the State or through the provision of a grant or contract to a
p.001313: nonprofit private entity.
p.001313: (2) The programs are carried out in accordance with guide- lines issued under subsection (b).
p.001313: (3) Not less than $100,000 is available for the fund.
p.001313: (4) Loans made from the revolving fund do not exceed
p.001313: $4,000 and each such loan is repaid to the revolving fund by the residents of the housing involved not
p.001313: later than 2 years after the date on which the loan is made.
p.001313: (5) Each such loan is repaid by such residents through monthly installments, and a reasonable penalty is
p.001313: assessed for each failure to pay such periodic installments by the date spec- ified in the loan agreement involved.
p.001313: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001313:
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p.001313: Sec. 1926 PUBLIC HEALTH SERVICE ACT 1314
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p.001313:
p.001313: January 30, 2020
p.001313:
p.001313: (6) Such loans are made only to nonprofit private entities agreeing that, in the operation of the program
p.001313: established pur- suant to the loan—
p.001313: (A) the use of alcohol or any illegal drug in the hous- ing provided by the program will be prohibited;
p.001313: (B) any resident of the housing who violates such pro- hibition will be expelled from the housing;
p.001313: (C) the costs of the housing, including fees for rent and utilities, will be paid by the residents of the
p.001313: housing; and
p.001313: (D) the residents of the housing will, through a major- ity vote of the residents, otherwise establish policies
p.001313: gov- erning residence in the housing, including the manner in which applications for residence in the
p.001313: housing are ap- proved.
p.001313: (b) ISSUANCE BY SECRETARY OF GUIDELINES.—The Secretary shall ensure that there are in effect
p.001313: guidelines under this subpart for the operation of programs described in subsection (a).
p.001313: (c) APPLICABILITY TO TERRITORIES.—The requirements estab- lished in subsection (a) shall not apply to any
p.001313: territory of the United States other than the Commonwealth of Puerto Rico.
p.001313: SEC. 1926. ø300x–26¿ SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 21.
p.001313: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved will—
p.001313: (1) annually conduct random, unannounced inspections to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21; and
p.001313: (2) annually submit to the Secretary a report describing—
p.001313: (A) the activities carried out by the State to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21;
...

p.001333: (a) IN GENERAL.—Of the amount allotted to the State of Ha- waii under section 1911, and the amount
p.001333: allotted to such State under section 1921, an amount equal to the proportion of Native Hawaiians residing
p.001333: in the State to the total population of the State shall be available, respectively, for carrying out the
p.001333: program in- volved for Native Hawaiians.
p.001333: (b) EXPENDITURE OF AMOUNTS.—The amount made available under subsection (a) may be expended only through
p.001333: contracts en- tered into by the State of Hawaii with public and private nonprofit organizations to enable such
p.001333: organizations to plan, conduct, and administer comprehensive substance use disorder and treatment programs
p.001333: for the benefit of Native Hawaiians. In entering into con- tracts under this section, the State of Hawaii shall give
p.001333: preference to Native Hawaiian organizations and Native Hawaiian health cen- ters.
p.001333: (c) DEFINITIONS.—For the purposes of this subsection 18, the terms ‘‘Native Hawaiian’’, ‘‘Native Hawaiian
p.001333: organization’’, and ‘‘Native Hawaiian health center’’ have the meaning given such terms in section 2308 of
p.001333: subtitle D of title II of the Anti-Drug Abuse Act of 1988.
p.001333: SEC. 1954. ø300x–64¿ DEFINITIONS.
p.001333: (a) DEFINITIONS FOR SUBPART III.—For purposes of this sub- part:
p.001333: (1) The term ‘‘program involved’’ means the program of grants established in section 1911 or 1921, or
p.001333: both, as indi- cated by whether the State involved is receiving or is applying to receive a grant under section 1911
p.001333: or 1921, or both.
p.001333: (2)(A) The term ‘‘funding agreement’’, with respect to a grant under section 1911, has the meaning given such
p.001333: term in section 1919.
p.001333: (B) The term ‘‘funding agreement’’, with respect to a grant under section 1921, has the meaning given such term
p.001333: in sec- tion 1934.
p.001333: (b) DEFINITIONS FOR PART B.—For purposes of this part:
p.001333: (1) The term ‘‘Comptroller General’’ means the Comptroller General of the United States.
p.001333:
p.001333:
p.001333:
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p.001333: January 30, 2020
p.001333: 17 Section 1952 appears according to the probable intent of the Congress. Section 3403(b) of Public Law
p.001333: 106–310 (114 Stat. 1220) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1952 ‘‘is amended to read as follows:’’.
p.001333: 18 So in law. See section 203 of Public Law 102–321 (106 Stat. 409). Probably should be ‘‘sec- tion’’.
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001355: or programs which do not advocate, promote, or encourage abor- tion.
p.001355: (b) The Secretary shall ascertain whether programs or projects comply with subsection (a) and take appropriate action
p.001355: if programs or projects do not comply with such subsection, including with- holding of funds.
p.001355: TITLE XXI—VACCINES
p.001355: Subtitle 1—National Vaccine Program
p.001355: ESTABLISHMENT
p.001355: SEC. 2101. ø300aa–1¿ The Secretary shall establish in the De- partment of Health and Human Services a National
p.001355: Vaccine Pro- gram to achieve optimal prevention of human infectious diseases through immunization and to
p.001355: achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a
p.001355: Director selected by the Secretary.
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p.001355: January 30, 2020
p.001355:
p.001355: PROGRAM RESPONSIBILITIES
p.001355: SEC. 2102. ø300aa–2¿ (a) The Director of the Program shall have the following responsibilities:
p.001355: (1) VACCINE RESEARCH.—The Director of the Program shall, through the plan issued under section 2103,
p.001355: coordinate and provide direction for research carried out in or through the National Institutes of Health, the
p.001355: Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug
p.001355: Administration, the Department of Defense, and the Agency for International Development on means to in- duce human
p.001355: immunity against naturally occurring infectious diseases and to prevent adverse reactions to vaccines.
p.001355: (2) VACCINE DEVELOPMENT.—The Director of the Program shall, through the plan issued under section 2103,
p.001355: coordinate and provide direction for activities carried out in or through the National Institutes of
p.001355: Health, the Office of Biologics Re- search and Review of the Food and Drug Administration, the Department
p.001355: of Defense, and the Agency for International De- velopment to develop the techniques needed to produce
p.001355: safe and effective vaccines.
p.001355: (3) SAFETY AND EFFICACY TESTING OF VACCINES.—The Di- rector of the Program shall, through the plan issued under
p.001355: sec- tion 2103, coordinate and provide direction for safety and effi- cacy testing of vaccines carried out in
p.001355: or through the National Institutes of Health, the Centers for Disease Control and Pre- vention, the Office
p.001355: of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the
p.001355: Agency for International Development.
p.001355: (4) LICENSING OF VACCINE MANUFACTURERS AND VAC- CINES.—The Director of the Program shall,
p.001355: through the plan issued under section 2103, coordinate and provide direction for the allocation of resources in the
p.001355: implementation of the licens- ing program under section 353.
p.001355: (5) PRODUCTION AND PROCUREMENT OF VACCINES.—The Di- rector of the Program shall, through the plan issued under sec-
p.001355: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001357: 1357
p.001357: PUBLIC HEALTH SERVICE ACT
p.001357: Sec. 2103
p.001357:
p.001357: tion 2103, ensure that the governmental and non-governmental production and procurement of safe and effective
p.001357: vaccines by the Public Health Service, the Department of Defense, and the Agency for International Development
p.001357: meet the needs of the United States population and fulfill commitments of the United States to
p.001357: prevent human infectious diseases in other countries.
p.001357: (6) DISTRIBUTION AND USE OF VACCINES.—The Director of the Program shall, through the plan issued under section
p.001357: 2103, coordinate and provide direction to the Centers for Disease Control and Prevention and assistance to
p.001357: States, localities, and health practitioners in the distribution and use of vaccines, in- cluding efforts to
p.001357: encourage public acceptance of immuniza- tions and to make health practitioners and the public aware of potential
p.001357: adverse reactions and contraindications to vaccines.
p.001357: (7) EVALUATING THE NEED FOR AND THE EFFECTIVENESS AND ADVERSE EFFECTS OF VACCINES AND IMMUNIZATION
p.001357: ACTIVI- TIES.—The Director of the Program shall, through the plan issued under section 2103, coordinate
p.001357: and provide direction to the National Institutes of Health, the Centers for Disease Con- trol and Prevention, the
p.001357: Office of Biologics Research and Re- view of the Food and Drug Administration, the National Cen- ter for
p.001357: Health Statistics, the National Center for Health Serv- ices Research and Health Care Technology Assessment, and
p.001357: the Centers for Medicare & Medicaid Services in monitoring the need for and the effectiveness and
p.001357: adverse effects of vac- cines and immunization activities.
p.001357: (8) COORDINATING GOVERNMENTAL AND NON-GOVERN- MENTAL ACTIVITIES.—The Director of the Program
p.001357: shall, through the plan issued under section 2103, provide for the ex- change of information between Federal
p.001357: agencies involved in the implementation of the Program and non-governmental en- tities engaged in the
p.001357: development and production of vaccines and in vaccine research and encourage the investment of non- governmental
p.001357: resources complementary to the governmental activities under the Program.
p.001357: (9) FUNDING OF FEDERAL AGENCIES.—The Director of the Program shall make available to Federal agencies
p.001357: involved in the implementation of the plan issued under section 2103 funds appropriated under section
p.001357: 2106 to supplement the funds otherwise available to such agencies for activities under the plan.
p.001357: (b) In carrying out subsection (a) and in preparing the plan under section 2103, the Director shall
p.001357: consult with all Federal agencies involved in research on and development, testing, licens- ing, production,
p.001357: procurement, distribution, and use of vaccines.
p.001357:
p.001357:
p.001357:
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p.001357:
p.001357:
p.001357:
p.001357:
p.001357: January 30, 2020
p.001357:
p.001357: PLAN
p.001357: SEC. 2103. ø300aa–3¿ The Director of the Program shall pre- pare and issue a plan for the implementation of
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p.001379:
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p.001379: January 30, 2020
p.001379: 20 Effective October 1, 1988.
p.001379: 21 See footnote for section 2112(g).
p.001379: 22 The amendment described in section 201(d)(3)(C) of Public Law 102–168 (105 Stat. 1103) has been executed
p.001379: according to the probable intent of the Congress. After redesignating former subparagraphs (A) and (B) as paragraphs
p.001379: (1) and (2), the amendatory instructions of the section provided that section 2121(b) is amended ‘‘by running
p.001379: the text of paragraph (1) into the sub- section heading and making the margin of the text full measure’’. The
p.001379: instructions were applied to portions of the matter preceding paragraph (1) as redesignated, rather than to
p.001379: the text of paragraph (1). (That is, the instructions were applied to the former paragraph (1).)
p.001379: 23 Effective October 1, 1988.
p.001379: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001379:
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p.001381: 1381
p.001381: PUBLIC HEALTH SERVICE ACT
p.001381: Sec. 2123
p.001381:
p.001381: erly prepared and was accompanied by proper directions and warnings.
p.001381: (2) For purposes of paragraph (1), a vaccine shall be pre- sumed to be accompanied by proper directions and
p.001381: warnings if the vaccine manufacturer shows that it complied in all mate- rial respects with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service
p.001381: Act (including regulations issued under such provi- sions) applicable to the vaccine and related to
p.001381: vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
p.001381: (A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section
p.001381: 2123(d)(2), or
p.001381: (B) by clear and convincing evidence that the manufac- turer failed to exercise due care notwithstanding its
p.001381: com- pliance with such Act and section (and regulations issued under such provisions).
p.001381: (c) DIRECT WARNINGS.—No vaccine manufacturer shall be lia- ble in a civil action for damages arising
p.001381: from a vaccine-related in- jury or death associated with the administration of a vaccine after the effective date
p.001381: of this part 24 solely due to the manufacturer’s failure to provide direct warnings to the injured
p.001381: party (or the in- jured party’s legal representative) of the potential dangers result- ing from the
p.001381: administration of the vaccine manufactured by the manufacturer.
p.001381: (d) CONSTRUCTION.—The standards of responsibility prescribed by this section are not to be construed as authorizing a
p.001381: person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in
p.001381: which damages were denied or which was dismissed with prejudice to bring a new civil action against such
p.001381: manufacturer for such injury or death.
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p.001381: TRIAL
p.001381: SEC. 2123. ø300aa–23¿ (a) GENERAL RULE.—A civil action against a vaccine manufacturer for damages
p.001381: for a vaccine-related injury or death associated with the administration of a vaccine after the effective
p.001381: date of this part 24 which is not barred by section 2111(a)(2) shall be tried in three stages.
p.001381: (b) LIABILITY.—The first stage of such a civil action shall be held to determine if a vaccine manufacturer is
p.001381: liable under section 2122.
p.001381: (c) GENERAL DAMAGES.—The second stage of such a civil action shall be held to determine the amount of damages (other
p.001381: than pu- nitive damages) a vaccine manufacturer found to be liable under section 2122 shall be required to
p.001381: pay.
p.001381: (d) PUNITIVE DAMAGES.—
p.001381: (1) If sought by the plaintiff, the third stage of such an ac- tion shall be held to determine the amount of
p.001381: punitive dam-
p.001381:
p.001381:
p.001381:
p.001381: January 30, 2020
p.001381: 24 Effective October 1, 1988.
p.001381:
p.001381: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001381:
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p.001381: Sec. 2125 PUBLIC HEALTH SERVICE ACT 1382
p.001381:
p.001381: ages a vaccine manufacturer found to be liable under section 2122 shall be required to pay.
p.001381: (2) If in such an action the manufacturer shows that it complied, in all material respects, with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act applicable to
p.001381: the vaccine and related to the vaccine injury or death with respect to which the action was brought, the
p.001381: manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
p.001381: (A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a pro-
p.001381: ceeding for approval of the vaccine under section 351,
p.001381: (B) intentional and wrongful withholding of informa- tion relating to the safety or efficacy of the
p.001381: vaccine after its approval, or
p.001381: (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
p.001381: which activity related to the vaccine-related injury or death for which the civil action was brought.
p.001381: (e) EVIDENCE.—In any stage of a civil action, the Vaccine In- jury Table, any finding of fact or
p.001381: conclusion of law of the United States Claims Court or a special master in a proceeding on a peti- tion filed
p.001381: under section 2111 and the final judgment of the United States Claims Court and subsequent appellate review on such a
p.001381: pe- tition shall not be admissible.
p.001381: PART C—ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES
p.001381:
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p.001381: January 30, 2020
p.001381:
p.001381: RECORDING AND REPORTING OF INFORMATION
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p.001383: administration of the vaccine.
p.001383: (3) Except as provided in paragraph (1), all information re- ported under this section shall be available to the
p.001383: public.
p.001383: VACCINE INFORMATION
p.001383: SEC. 2126. ø300aa–26¿ (a) GENERAL RULE.—Not later than 1 year after the effective date of this part,
p.001383: the Secretary shall de- velop and disseminate vaccine information materials for distribu- tion by health
p.001383: care providers to the legal representatives of any child or to any other individual receiving a vaccine set
p.001383: forth in the Vaccine Injury Table. Such materials shall be published in the Fed- eral Register and may be revised.
p.001383: (b) DEVELOPMENT AND REVISION OF MATERIALS.—Such mate- rials shall be developed or revised—
p.001383:
p.001383:
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p.001383: January 30, 2020
p.001383: 25 Effective December 22, 1987.
p.001383: 26 Effective December 22, 1987.
p.001383:
p.001383:
p.001383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001383:
p.001383:
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p.001383: Sec. 2127 PUBLIC HEALTH SERVICE ACT 1384
p.001383:
p.001383: (1) after notice to the public and 60 days of comment thereon, and
p.001383: (2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers
p.001383: and par- ent organizations, the Centers for Disease Control and Preven- tion, and the Food and Drug Administration.
p.001383: (c) INFORMATION REQUIREMENTS.—The information in such ma- terials shall be based on available data and
p.001383: information, shall be presented in understandable terms and shall include—
p.001383: (1) a concise description of the benefits of the vaccine,
p.001383: (2) a concise description of the risks associated with the vaccine,
p.001383: (3) a statement of the availability of the National Vaccine Injury Compensation Program, and
p.001383: (4) such other relevant information as may be determined by the Secretary.
p.001383: (d) HEALTH CARE PROVIDER DUTIES.—On and after a date de- termined by the Secretary which is—
p.001383: (1) after the Secretary develops the information materials required by subsection (a), and
p.001383: (2) not later than 6 months after the date such materials are published in the Federal Register,
p.001383: each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to
p.001383: the legal representatives of any child or to any other individual to whom such provider in- tends to
p.001383: administer such vaccine a copy of the information mate- rials developed pursuant to subsection (a),
p.001383: supplemented with vis- ual presentations or oral explanations, in appropriate cases. Such materials shall be
p.001383: provided prior to the administration of such vac- cine.
p.001383: MANDATE FOR SAFER CHILDHOOD VACCINES
p.001383: SEC. 2127. ø300aa–27¿ (a) GENERAL RULE.—In the administra- tion of this subtitle and other pertinent laws under the
p.001383: jurisdiction of the Secretary, the Secretary shall—
p.001383: (1) promote the development of childhood vaccines that re- sult in fewer and less serious adverse reactions than those
p.001383: vac- cines on the market on the effective date of this part 27 and promote the refinement of such vaccines,
p.001383: and
p.001383: (2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to,
p.001383: the licensing, manufacturing, processing, testing, labeling, warning, use in- structions, distribution,
p.001383: storage, administration, field surveil- lance, adverse reaction reporting, and recall of reactogenic lots or
p.001383: batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.
p.001383: (b) TASK FORCE.—
p.001383: (1) The Secretary shall establish a task force on safer childhood vaccines which shall consist of the
p.001383: Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and
p.001383: the Director of the Centers for Disease Control.
p.001383:
p.001383:
p.001383:
p.001383: January 30, 2020
p.001383: 27 Effective December 22, 1987.
p.001383:
p.001383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001383:
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p.001385: 1385
p.001385: PUBLIC HEALTH SERVICE ACT
p.001385: Sec. 2128
p.001385:
p.001385: (2) The Director of the National Institutes of Health shall serve as chairman of the task force.
p.001385: (3) In consultation with the Advisory Commission on Childhood Vaccines, the task force shall
p.001385: prepare recommenda- tions to the Secretary concerning implementation of the re- quirements of subsection (a).
p.001385: (c) REPORT.—Within 2 years after the effective date of this part, 27 and periodically thereafter, the
p.001385: Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the
p.001385: Committee on Labor and Human Re- sources of the Senate a report describing the actions taken pursu- ant
p.001385: to subsection (a) during the preceding 2-year period.
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p.001395: beginning on the date on which the solici- tation was issued.
p.001395: (d) ANNUAL REPORTS TO CONGRESS.—Except as provided in subsection (e), the Secretary shall annually
p.001395: prepare, for inclusion in the comprehensive report required in section 2301, a report—
p.001395:
p.001395: (A) 2 summarizing programs for which the Secretary has made a determination described in subsection
p.001395: (b)(2), including a description of the time limitations as adjusted by the deter- mination and including a
p.001395: summary of the solicitation issued by the Secretary for proposals pursuant to the program; and
p.001395: (B) summarizing applications that—
p.001395: (i) were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in
p.001395: para- graph (1) of subsection (b) for which a determination de- scribed in paragraph (2) of such
p.001395: subsection has not been made; and
p.001395: (ii) were not processed in accordance with the time limitations described in such paragraph (1).
p.001395: (e) QUARTERLY REPORTS FOR FISCAL YEAR 1989.—For fiscal year 1989, the report required in subsection (d)
p.001395: shall, not less than quarterly, be prepared and submitted to the Committee on Energy and Commerce of the House of
p.001395: Representatives and the Committee on Labor and Human Resources of the Senate.
p.001395: SEC. 2303. ø300cc–2¿ REQUIREMENTS WITH RESPECT TO PROCESSING OF REQUESTS FOR PERSONNEL AND
p.001395: ADMINISTRATIVE SUPPORT.
p.001395: (a) IN GENERAL.—The Director of the Office of Personnel Man- agement or the Administrator of General Services, as the
p.001395: case may be, shall respond to any priority request made by the Adminis- trator of the Alcohol, Drug Abuse,
p.001395: and Mental Health Administra- tion, the Director of the Centers for Disease Control and Preven- tion, the
p.001395: Commissioner of Food and Drugs, or the Director of the National Institutes of Health, not later than 21 days
p.001395: after the date on which such request is made. If the Director of the Office of Per- sonnel Management or the
p.001395: Administrator of General Services, as
p.001395:
p.001395:
p.001395:
p.001395:
p.001395: January 30, 2020
p.001395: 2 Designations are so in law. Subparagraphs (A) and (B) should probably be designated para- graphs (1) and (2),
p.001395: respectively. Similarly, clauses (i) and (ii) of subparagraph (B) should prob- ably be designated
p.001395: subparagraphs (A) and (B), respectively.
p.001395: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001395:
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p.001397: 1397
p.001397: PUBLIC HEALTH SERVICE ACT
p.001397: Sec. 2304
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p.001397: (3) conduct studies and convene meetings for the purpose of determining the recommendations among physicians in
p.001397: clin- ical practice on clinical treatment of acquired immune defi- ciency syndrome, including treatment with
p.001397: the drugs described in paragraph (1); and
p.001397: (4) conduct a study for the purpose of developing, with re- spect to individuals infected with the etiologic
p.001397: agent for ac- quired immune deficiency syndrome, a consensus among health care professionals on clinical
p.001397: treatments for preventing or minimizing the development of symptoms or conditions arising from infection with
p.001397: such etiologic agent.
p.001397: PART B—RESEARCH AUTHORITY
p.001397: SEC. 2311. ø300cc–11¿ CLINICAL EVALUATION UNITS AT NATIONAL IN- STITUTES OF HEALTH.
p.001397: (a) IN GENERAL.—The Secretary, acting through the Director of the National Cancer Institute and the Director of the
p.001397: National In- stitute of Allergy and Infectious Diseases, shall for each such Insti- tute establish a clinical
p.001397: evaluation unit at the Clinical Center at the National Institutes of Health. Each of the clinical
p.001397: evaluation units—
p.001397:
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p.001397:
p.001397: January 30, 2020
p.001397: (1) shall conduct clinical evaluations of experimental treat- ments for acquired immune deficiency syndrome
p.001397: developed within the preclinical drug development program, including evaluations of methods of diagnosing
p.001397: immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic
p.001397: cancers and infectious diseases; and
p.001397: (2) may conduct clinical evaluations of experimental treat- ments for such syndrome that are developed by any
p.001397: other na- tional research institute of the National Institutes of Health or by any other entity.
p.001397: (b) PERSONNEL AND ADMINISTRATIVE SUPPORT.—
p.001397: (1) For the purposes described in subsection (a), the Sec- retary, acting through the Director of the
p.001397: National Institutes of Health, shall provide each of the clinical evaluation units re- quired in such subsection—
p.001397: (A)(i) with not less than 50 beds; or
p.001397: (ii) with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity,
p.001397: with re- spect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National
p.001397: Institutes of Health on June 1, 1988; and
p.001397: (B) with such personnel, such administrative support, and such other support services as may be necessary.
p.001397: (2) Facilities, personnel, administrative support, and other support services provided pursuant to paragraph (1) shall
p.001397: be in addition to the number or level of facilities, personnel, admin- istrative support, and other support
p.001397: services that otherwise
p.001397: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001397:
p.001397:
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p.001399: 1399
p.001399: PUBLIC HEALTH SERVICE ACT
p.001399: Sec. 2312
p.001399:
p.001399: would be available at the Clinical Center at the National Insti- tutes of Health for the provision of clinical care for
p.001399: individuals with diseases or disorders.
p.001399: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001399: to be appropriated such sums as may be necessary.
p.001399: SEC. 2312. ø300cc–12¿ USE OF INVESTIGATIONAL NEW DRUGS WITH RE- SPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME.
p.001399: (a) ENCOURAGEMENT OF APPLICATIONS WITH RESPECT TO CLIN-
p.001399: ICAL TRIALS.—
p.001399: (1) If, in the determination of the Secretary, there is pre- liminary evidence that a new drug has
p.001399: effectiveness in humans with respect to the prevention or treatment of acquired im- mune deficiency
p.001399: syndrome, the Secretary shall, through state- ments published in the Federal Register—
p.001399: (A) announce the fact of such determination; and
p.001399: (B) with respect to the new drug involved, encourage an application for an exemption for investigational
p.001399: use of the new drug under regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act.
p.001399: (2)(A) The AIDS Research Advisory Committee established pursuant to section 2304 shall make recommendations to
p.001399: the Secretary with respect to new drugs appropriate for determina- tions described in paragraph (1).
p.001399: (B) The Secretary shall, as soon as is practicable, deter- mine the merits of recommendations received by the
p.001399: Secretary pursuant to subparagraph (A).
p.001399: (b) ENCOURAGEMENT OF APPLICATIONS WITH RESPECT TO TREATMENT USE IN CIRCUMSTANCES OTHER
p.001399: THAN CLINICAL TRIALS.—
p.001399: (1) In the case of a new drug with respect to which the Secretary has made a determination described in
p.001399: subsection (a) and with respect to which an exemption is in effect for pur- poses of section 505(i) of the
p.001399: Federal Food, Drug, and Cosmetic Act, the Secretary shall—
p.001399: (A) as appropriate, encourage the sponsor of the inves- tigation of the new drug to submit to the Secretary, in ac-
p.001399: cordance with regulations issued under such section, an application to use the drug in the treatment of
p.001399: individ- uals—
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p.001399: January 30, 2020
p.001399: (i) who are infected with the etiologic agent for ac- quired immune deficiency syndrome; and
p.001399: (ii) who are not participating in the clinical trials conducted pursuant to such exemption; and
p.001399: (B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in
p.001399: ac- cordance with such regulations, the new drug from such sponsor for the purpose of treating such
p.001399: individuals.
p.001399: (2) If the sponsor of the investigation of a new drug de- scribed in paragraph (1) does not submit to
p.001399: the Secretary an application described in such paragraph (relating to treatment use), the Secretary shall, through
p.001399: statements published in the Federal Register, encourage, as appropriate, licensed medical
p.001399: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001399:
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p.001399: Sec. 2313 PUBLIC HEALTH SERVICE ACT 1400
p.001399:
p.001399: practitioners to submit to the Secretary such applications in accordance with regulations described in such
p.001399: paragraph.
p.001399: (c) TECHNICAL ASSISTANCE WITH RESPECT TO TREATMENT USE.—In the case of a new drug with respect
p.001399: to which the Sec- retary has made a determination described in subsection (a), the Secretary may,
p.001399: directly or through grants or contracts, provide technical assistance with respect to the process of—
p.001399: (1) submitting to the Secretary applications for exemptions described in paragraph (1)(B) of such subsection;
p.001399: (2) submitting to the Secretary applications described in subsection (b); and
p.001399: (3) with respect to sponsors of investigations of new drugs, facilitating the transfer of new drugs from such sponsors
p.001399: to li- censed medical practitioners.
p.001399: (d) DEFINITION.—For purposes of this section, the term ‘‘new drug’’ has the meaning given such term in section
p.001399: 201 of the Fed- eral Food, Drug, and Cosmetic Act.
p.001399: SEC. 2313. ø300cc–13¿ TERRY BEIRN COMMUNITY-BASED AIDS RE- SEARCH INITIATIVE.
p.001399: (a) IN GENERAL.—After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of
p.001399: Health, acting through the National Institute 3 of Allergy and Infectious Diseases, may make grants to public
p.001399: entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into
p.001399: contracts with public and private such entities, for the purpose of planning and conducting, in the
p.001399: community in- volved, clinical trials of experimental treatments for infection with the etiologic agent for such
p.001399: syndrome that are approved by the Commissioner of Food and Drugs for investigational use under reg- ulations
p.001399: issued under section 505 of the Federal Food, Drug, and Cosmetic Act.
p.001399: (b) REQUIREMENT OF CERTAIN PROJECTS.—
p.001399: (1) Financial assistance under subsection (a) shall include such assistance to community-based organizations and
p.001399: commu- nity health centers for the purpose of—
p.001399: (A) retaining appropriate medical supervision;
p.001399: (B) assisting with administration, data collection and record management; and
p.001399: (C) conducting training of community physicians, nurse practitioners, physicians’ assistants and other health
p.001399: professionals for the purpose of conducting clinical trials. (2)(A) Financial assistance under subsection
p.001399: (a) shall in- clude such assistance for demonstration projects designed to implement and conduct
p.001399: community-based clinical trials in order to provide access to the entire scope of communities af-
p.001399: fected by infections with the etiologic agent for acquired im- mune deficiency syndrome, including
p.001399: minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and
p.001399: individuals who are asymptomatic with
p.001399: respect to such infection.
p.001399:
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p.001399:
p.001399: January 30, 2020
p.001399: 3 So in law. Probably should be ‘‘acting through the Director of the National Institute’’. (Sec- tion
p.001399: 2617(b)(1) of Public Law 100–690 expressed the intent to so amend the provision; however, the amendment cannot be
p.001399: executed because the amendatory instructions are to strike ‘‘through the National Institutes of Allergy’’, and this
p.001399: term does not appear in subsection (a) (above).)
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p.001405: than the United States.
p.001405: (d) DATA BANK ON CLINICAL TRIALS AND TREATMENTS.—
p.001405: (1) After consultation with the Commissioner of Food and Drugs, the AIDS Research Advisory Committee
p.001405: established under section 2304, and the Director of the Office of AIDS Re- search, the Secretary shall, in
p.001405: carrying out subsection (a), es- tablish a data bank of information on clinical trials and treat- ments with
p.001405: respect to infection with the etiologic agent for ac- quired immune deficiency syndrome (hereafter in this
p.001405: section referred to as the ‘‘Data Bank’’).
p.001405: (2) In carrying out paragraph (1), the Secretary shall col- lect, catalog, store, and disseminate the
p.001405: information described in such paragraph. The Secretary shall disseminate such infor- mation through information
p.001405: systems available to individuals infected with the etiologic agent for acquired immune defi- ciency
p.001405: syndrome, to other members of the public, to health care providers, and to researchers.
p.001405: (e) REQUIREMENTS WITH RESPECT TO DATA BANK ON CLINICAL TRIALS AND TREATMENTS.—The Data Bank shall include
p.001405: the fol- lowing:
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p.001405: (1) A registry of clinical trials of experimental treatments for acquired immune deficiency syndrome and
p.001405: related illnesses conducted under regulations promulgated pursuant to section 505 of the Federal Food, Drug and
p.001405: Cosmetic Act that provides a description of the purpose of each experimental drug protocol either with the consent of
p.001405: the protocol sponsor, or when a trial to test efficacy begins. Information provided shall include eligi- bility
p.001405: criteria and the location of trial sites, and must be for- warded to the Data Bank by the sponsor of
p.001405: the trial not later than 21 days after the approval by the Food and Drug Admin- istration.
p.001405: (2) Information pertaining to experimental treatments for acquired immune deficiency syndrome that may be
p.001405: available under a treatment investigational new drug application that has been submitted to the Food and Drug
p.001405: Administration pur- suant to part 312 of title 21, Code of Federal Regulations. The Data Bank shall also include
p.001405: information pertaining to the re- sults of clinical trials of such treatments, with the consent of the
p.001405: sponsor, of such experimental treatments, including infor- mation concerning potential toxicities or adverse
p.001405: effects associ- ated with the use or administration of such experimental treat- ment.
p.001405: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001405: Sec. 2318 PUBLIC HEALTH SERVICE ACT 1406
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p.001405:
p.001405: SEC. 2318. ø300cc–18¿ DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE OF INFECTED INDIVIDUALS.
p.001405: (a) IN GENERAL.—
p.001405: (1) The Secretary, acting through the Director of the Na- tional Institutes of Health and after consultation
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p.001417: TITLE XXIV—HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001417: PART A—FORMULA GRANTS TO STATES FOR HOME AND COMMUNITY- BASED HEALTH SERVICES
p.001417: SEC. 2401. ø300dd¿ ESTABLISHMENT OF PROGRAM.
p.001417: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001417: fiscal years 1989 and 1990 make an allotment for each State in an amount deter- mined in accordance with
p.001417: section 2408. The Secretary shall make payments each such fiscal year to each State from the allotment for the
p.001417: State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant
p.001417: to section 2407.
p.001417: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001417: unless the State in- volved agrees to expend the payments only for the purpose of pro- viding services in accordance
p.001417: with section 2402.
p.001417: (c) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this part:
p.001417: (1) The term ‘‘eligible individual’’ means an individual in- fected with the etiologic agent for acquired
p.001417: immune deficiency syndrome who either is medically dependent or chronically de- pendent.
p.001417: (2) The term ‘‘medically dependent’’ means, with respect to an individual, that the individual has been certified by a
p.001417: physi- cian as—
p.001417: (A) requiring the routine use of appropriate medical services (which may include home intravenous drug
p.001417: ther- apy) to prevent or compensate for the individual’s serious deterioration, arising from infection
p.001417: with the etiologic agent for acquired immune deficiency syndrome, of phys- ical health or cognitive
p.001417: function, and
p.001417:
p.001417:
p.001417:
p.001417: January 30, 2020
p.001417: 1 See footnote at beginning of title XXIII.
p.001417:
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001417: Sec. 2402 PUBLIC HEALTH SERVICE ACT 1418
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p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
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p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
p.001417: (C) day treatment or other partial hospitalization serv- ices,
p.001417: (D) home intravenous drug therapy (including pre- scription drugs administered intravenously as part of such
p.001417: therapy), and
p.001417: (E) routine diagnostic tests administered in the indi- vidual’s home,
p.001417: furnished pursuant to such plan of care; but
p.001417: (3) does not include, except as specifically provided in paragraph (2)—
p.001417: (A) diagnostic tests,
p.001417: (B) inpatient hospital services,
p.001417: (C) nursing facility services, and
p.001417: (D) prescription drugs.
p.001417: SEC. 2402. ø300dd–1¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.001417: (a) REQUIRED USES OF FUNDS.—The Secretary may not make payments under section 2401(a) unless the State
p.001417: involved agrees that the State will—
p.001417: (1) provide for home and community-based health services for eligible individuals pursuant to written plans of care
p.001417: estab- lished by health care professionals for providing such services to such individuals;
p.001417: (2) provide for the identification, location, and provision of outreach to eligible individuals;
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001417:
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p.001419: 1419
p.001419: PUBLIC HEALTH SERVICE ACT
p.001419: Sec. 2404
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p.001429: individual may have exposed to such etiologic agent; and
p.001429: (6) the availability, if any, of the services of public health authorities with respect to locating and
p.001429: counseling any indi- vidual described in paragraph (5).
p.001429: (d) RULE OF CONSTRUCTION WITH RESPECT TO COUNSELING WITHOUT TESTING.—Agreements entered into
p.001429: pursuant to sub- sections (a) through (c) may not be construed to prohibit any grant- ee under section 2431 from
p.001429: expending the grant for the purpose of providing counseling services described in such subsections to an
p.001429: individual who will not undergo testing described in such section as a result of the grantee or the
p.001429: individual determining that such testing of the individual is not appropriate.
p.001429: (e) USE OF FUNDS.—
p.001429: (1) The purpose of this subpart 4 is to provide for coun- seling and testing services to prevent and
p.001429: reduce exposure to, and transmission of, the etiologic agent for acquired immune deficiency syndrome.
p.001429: (2) All individuals receiving counseling pursuant to this subpart 4 are to be counseled about the harmful
p.001429: effects of pro- miscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such
p.001429: activities.
p.001429: (3) None of the fund appropriated to carry out this sub- part 4 may be used to provide counseling
p.001429: that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous
p.001429: drug abuse.
p.001429: (4) Paragraph (3) may not be construed to prohibit a coun- selor who has already performed the counseling of an
p.001429: indi- vidual required by paragraph (2), to provide accurate informa- tion about means to reduce an individual’s risk
p.001429: of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
p.001429: informational materials used are not obscene.
p.001429: SEC. 2433. ø300dd–33¿ FUNDING.
p.001429: For the purpose of grants under section 2431, there are author- ized to be appropriated $100,000,000 for each of
p.001429: the fiscal years 1989 and 1990.
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429: January 30, 2020
p.001429: 4 Probably should be ‘‘part’’. See section 118(b)(1)(B) of Public Law 102–321 (106 Stat. 348).
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001429:
p.001429:
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p.001431: 1431
p.001431: PUBLIC HEALTH SERVICE ACT
p.001431: Sec. 2502
p.001431:
p.001431: TITLE XXV—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001431: SEC. 2500. ø300ee¿ USE OF FUNDS.
p.001431: (a) IN GENERAL.—The purpose of this title is to provide for the establishment of education and information
p.001431: programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune
p.001431: deficiency syndrome.
...

p.001459: (b) DIRECT FINANCIAL ASSISTANCE TO APPROPRIATE ENTITIES.—
p.001459: (1) IN GENERAL.—The chief elected official of an eligible area shall use amounts from a grant under section
p.001459: 2601 to pro- vide direct financial assistance to entities described in para- graph (2) for the purpose of
p.001459: providing core medical services and support services.
p.001459: (2) APPROPRIATE ENTITIES.—Direct financial assistance may be provided under paragraph (1) to public or
p.001459: nonprofit pri- vate entities, or private for-profit entities if such entities are the only available provider
p.001459: of quality HIV care in the area.
p.001459: (c) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001459: (1) IN GENERAL.—With respect to a grant under section 2601 for an eligible area for a grant year, the chief
p.001459: elected offi- cial of the area shall, of the portion of the grant remaining after reserving amounts for
p.001459: purposes of paragraphs (1) and (5)(B)(i) of subsection (h), use not less than 75 percent to pro- vide
p.001459: core medical services that are needed in the eligible area for individuals with HIV/AIDS who are
p.001459: identified and eligible under this title (including services regarding the co-occurring conditions of the
p.001459: individuals).
p.001459: (2) WAIVER.—
p.001459: (A) IN GENERAL.—The Secretary shall waive the appli- cation of paragraph (1) with respect to a chief elected offi- cial
p.001459: for a grant year if the Secretary determines that, with- in the eligible area involved—
p.001459: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001459:
p.001459:
p.001459:
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p.001459: Sec. 2604 PUBLIC HEALTH SERVICE ACT 1460
p.001459:
p.001459: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001459: this title.
p.001459: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing the chief elected official of an eligible area that a grant
p.001459: under section 2601 is being made for the area for a grant year, the Secretary shall inform the
p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
p.001459:
p.001459:
p.001459:
p.001459:
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p.001459:
p.001459:
p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
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p.001473: 1473
p.001473: PUBLIC HEALTH SERVICE ACT
p.001473: Sec. 2612
p.001473:
p.001473: of the Secretary to provide grants under part B is subject to section 2626(e)(2) (relating to the decrease in
p.001473: perinatal transmission of HIV/AIDS).
p.001473: SEC. 2612. ø300ff–22¿ GENERAL USE OF GRANTS.
p.001473: (a) IN GENERAL.—A State may use amounts provided under grants made under section 2611 for—
p.001473: (1) core medical services described in subsection (b);
p.001473: (2) support services described in subsection (c); and
p.001473: (3) administrative expenses described in section 2618(b)(3).
p.001473: (b) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001473: (1) IN GENERAL.—With respect to a grant under section 2611 for a State for a grant year, the State shall, of
p.001473: the portion of the grant remaining after reserving amounts for purposes of subparagraphs (A) and (E)(ii)(I) of
p.001473: section 2618(b)(3), use not less than 75 percent to provide core medical services that are needed in the
p.001473: State for individuals with HIV/AIDS who are identified and eligible under this title (including services
p.001473: re- garding the co-occurring conditions of the individuals).
p.001473: (2) WAIVER.—
p.001473: (A) IN GENERAL.—The Secretary shall waive the appli- cation of paragraph (1) with respect to a State for a grant year
p.001473: if the Secretary determines that, within the State—
p.001473: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001473: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001473:
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p.001473: Sec. 2612 PUBLIC HEALTH SERVICE ACT 1474
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p.001477: (b) PRIORITY.—In awarding grants under subsection (a), a State shall give priority to entities that
p.001477: provide assurances to the State that—
p.001477: (1) such entities will participate in HIV care consortia if such consortia exist within the State; and
p.001477: (2) such entities will utilize amounts provided under such grants for the provision of home- and
p.001477: community-based serv- ices to low-income individuals with HIV/AIDS.
p.001477: (c) DEFINITION.—As used in section 2611, the term ‘‘home- and community-based health services’’—
p.001477: (1) means, with respect to an individual with HIV/AIDS, skilled health services furnished to the
p.001477: individual in the indi- vidual’s home pursuant to a written plan of care established by a case management team, that
p.001477: shall include appropriate health care professionals, for the provision of such services and items described in
p.001477: paragraph (2);
p.001477: (2) includes—
p.001477: (A) durable medical equipment;
p.001477: (B) home health aide services and personal care serv- ices furnished in the home of the individual;
p.001477: (C) day treatment or other partial hospitalization serv- ices;
p.001477: (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such
p.001477: therapy);
p.001477: (E) routine diagnostic testing administered in the home of the individual; and
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001477:
p.001477:
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p.001477:
p.001479: 1479
p.001479: PUBLIC HEALTH SERVICE ACT
p.001479: Sec. 2616
p.001479:
p.001479: (F) appropriate mental health, developmental, and re- habilitation services; and
p.001479: (3) does not include—
p.001479: (A) inpatient hospital services; and
p.001479: (B) nursing home and other long term care facilities.
p.001479: SEC. 2615. ø300ff–25¿ CONTINUUM OF HEALTH INSURANCE COVERAGE.
p.001479: (a) IN GENERAL.—A State may use amounts received under a grant awarded under section 2611 to establish a
p.001479: program of finan- cial assistance under section 2612(b)(3)(F) to assist eligible low-in- come individuals with
p.001479: HIV/AIDS in—
p.001479: (1) maintaining a continuity of health insurance; or
p.001479: (2) receiving medical benefits under a health insurance program, including risk-pools.
p.001479: (b) LIMITATIONS.—Assistance shall not be utilized under sub- section (a)—
p.001479: (1) to pay any costs associated with the creation, capital- ization, or administration of a liability
...

p.001479: medical monitoring.
p.001479: Of the amount reserved by a State for a fiscal year for use under this section, the State may not
p.001479: use more than 5 percent to carry
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001479:
p.001479:
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p.001479: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1480
p.001479:
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p.001479: January 30, 2020
p.001479:
p.001479: out services under paragraph (6), except that the percentage appli- cable with respect to such paragraph is 10
p.001479: percent if the State demonstrates to the Secretary that such additional services are es- sential and in no way
p.001479: diminish access to the therapeutics described in subsection (a).
p.001479: (d) DUTIES OF THE SECRETARY.—In carrying out this section, the Secretary shall review the current
p.001479: status of State drug reim- bursement programs established under section 2612(2) and assess barriers to the
p.001479: expanded availability of the treatments described in subsection (a). The Secretary shall also examine the
p.001479: extent to which States coordinate with other grantees under this title to re- duce barriers to the expanded
p.001479: availability of the treatments de- scribed in subsection (a).
p.001479: (e) LIST OF CLASSES OF CORE ANTIRETROVIRAL THERA- PEUTICS.—For purposes of subsection (c)(1),
p.001479: the Secretary shall de- velop and maintain a list of classes of core antiretroviral thera- peutics, which
p.001479: list shall be based on the therapeutics included in the guidelines of the Secretary known as the
p.001479: Clinical Practice Guidelines for Use of HIV/AIDS Drugs, relating to drugs needed to manage symptoms associated with
p.001479: HIV. The preceding sentence does not affect the authority of the Secretary to modify such Guide- lines.
p.001479: (f) USE OF HEALTH INSURANCE AND PLANS.—
p.001479: (1) IN GENERAL.—In carrying out subsection (a), a State may expend a grant under section 2611 to
p.001479: provide the thera- peutics described in such subsection by paying on behalf of in- dividuals with HIV/AIDS the
p.001479: costs of purchasing or maintain- ing health insurance or plans whose coverage includes a full range of
p.001479: such therapeutics and appropriate primary care serv- ices.
p.001479: (2) LIMITATION.—The authority established in paragraph
p.001479: (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans
p.001479: to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing
p.001479: therapeutics described in subsection (a).
p.001479: (g) DRUG REBATE PROGRAM.—A State shall ensure that any drug rebates received on drugs purchased from funds
p.001479: provided pur- suant to this section are applied to activities supported under this subpart, with priority given to
p.001479: activities described under this sec- tion.
p.001479: SEC. 2617. ø300ff–27¿ STATE APPLICATION.
p.001479: (a) IN GENERAL.—The Secretary shall not make a grant to a State under section 2611 for a fiscal year unless
p.001479: the State prepares and submits, to the Secretary, an application at such time, in such form, and containing such
p.001479: agreements, assurances, and information as the Secretary determines to be necessary to carry out section
p.001479: 2611.
p.001479: (b) DESCRIPTION OF INTENDED USES AND AGREEMENTS.—The application submitted under subsection (a) shall
p.001479: contain—
p.001479: (1) a detailed description of the HIV-related services pro- vided in the State to individuals and
p.001479: families with HIV/AIDS during the year preceding the year for which the grant is re-
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001479:
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p.001481: 1481
p.001481: PUBLIC HEALTH SERVICE ACT
p.001481: Sec. 2617
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p.001491: (E) CODE-BASED STATES; LIMITATION ON INCREASE IN GRANT.—
p.001491: (i) IN GENERAL.—For each of the fiscal years 2007 through 2012, if code-based reporting (within the meaning
p.001491: of subparagraph (D)(vi)) applies in a State as of the beginning of the fiscal year involved, then not-
p.001491: withstanding any other provision of this paragraph, the amount of the grant pursuant to paragraph (1) for the
p.001491: State may not for the fiscal year involved exceed by more than 5 percent the amount of the grant pur-
p.001491: suant to this paragraph for the State for the preceding fiscal year, except that the limitation under this clause may
p.001491: not result in a grant pursuant to paragraph (1) for a fiscal year that is less than the minimum amount that
p.001491: applies to the State under such paragraph for such fiscal year.
p.001491: (ii) USE OF AMOUNTS INVOLVED.—For each of the fiscal years 2007 through 2012, amounts available as a
p.001491: result of the limitation under clause (i) shall be
p.001491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001491:
p.001491:
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p.001491: Sec. 2618 PUBLIC HEALTH SERVICE ACT 1492
p.001491: made available by the Secretary as additional amounts for grants pursuant to section 2620,
p.001491: subject to subparagraph (H).
p.001491: (F) 9 APPROPRIATIONS FOR TREATMENT DRUG PRO- GRAM.—
p.001491: (i) FORMULA GRANTS.—With respect to the fiscal year involved, if under section 2623 an appropriations Act
p.001491: provides an amount exclusively for carrying out section 2616, the portion of such amount allocated to a
p.001491: State shall be the product of—
p.001491: (I) 10 100 percent of such amount, less the percent- age reserved under clause (ii)(V); and
p.001491: (II) 10 the percentage constituted by the ratio of the State distribution factor for the State (as
p.001491: deter- mined under subparagraph (B)) to the sum of the State distribution factors for all States;
p.001491: which product shall then, as applicable, be increased under subparagraph (H).
p.001491: (ii) SUPPLEMENTAL TREATMENT DRUG GRANTS.—
p.001491: (I) IN GENERAL.—From amounts made avail- able under subclause (V), the Secretary shall award
p.001491: supplemental grants to States described in subclause (II) to enable such States to purchase and distribute to
p.001491: eligible individuals under section 2616(b) pharmaceutical therapeutics described under subsections (c)(2) and
p.001491: (e) of such section.
p.001491: (II) ELIGIBLE STATES.—For purposes of sub- clause (I), a State shall be an eligible State if the State did not
p.001491: have unobligated funds subject to re- allocation under section 2618(d) in the previous fiscal year and, in
p.001491: accordance with criteria estab- lished by the Secretary, demonstrates a severe need for a grant under
p.001491: this clause. For purposes of determining severe need, the Secretary shall consider eligibility standards,
p.001491: formulary composi- tion, the number of eligible individuals to whom a State is unable to provide therapeutics
p.001491: described in section 2616(a), and an unanticipated increase of eligible individuals with HIV/AIDS.
p.001491: (III) STATE REQUIREMENTS.—The Secretary may not make a grant to a State under this clause unless the State
p.001491: agrees that the State will make available (directly or through donations of public or private entities)
p.001491: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to $1
p.001491: for each $4 of Fed- eral funds provided in the grant, except that the Secretary may waive this subclause
p.001491: if the State has otherwise fully complied with section 2617(d)
p.001491:
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p.001491: January 30, 2020
p.001491: 9 The amendments made by section 203(c) of Public Law 109–415 to section 2618(a)(2)(G) have been carried out to
p.001491: subparagraph (F), as redesignated by subsection (b)(4) of such Public Law, in order to reflect the probable
p.001491: intent of Congress.
p.001491: 10 Indentation of subclauses (I) and (II) are so in law. See section 206(e)(1) of Public Law 106– 345 (114 Stat. 1336).
p.001491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001493: 1493
p.001493: PUBLIC HEALTH SERVICE ACT
p.001493: Sec. 2618
p.001493:
p.001493: with respect to the grant year involved. The provi- sions of this subclause shall apply to States that are
p.001493: not required to comply with such section 2617(d).
p.001493: (IV) USE AND COORDINATION.—Amounts made available under a grant under this clause shall only be used by the
p.001493: State to provide HIV/AIDS-re- lated medications. The State shall coordinate the use of such amounts with the
p.001493: amounts otherwise provided under section 2616(a) in order to maxi- mize drug coverage.
p.001493: (V) FUNDING.—For the purpose of making grants under this clause, the Secretary shall each fiscal year
p.001493: reserve 5 percent of the amount re- ferred to in clause (i) with respect to section 2616.
p.001493: (iii) CODE-BASED STATES; LIMITATION ON INCREASE IN FORMULA GRANT.—The limitation under subpara- graph
p.001493: (E)(i) applies to grants pursuant to clause (i) of this subparagraph to the same extent and in the same manner as
p.001493: such limitation applies to grants pursuant to paragraph (1), except that the reference to min- imum
p.001493: grants does not apply for purposes of this clause. Amounts available as a result of the limitation under
p.001493: the preceding sentence shall be made available by the Secretary as additional amounts for grants under
p.001493: clause (ii) of this subparagraph.
p.001493: (H) 11 INCREASE IN FORMULA GRANTS.—
p.001493: (i) ASSURANCE OF AMOUNT.—
p.001493: (I) GENERAL RULE.—For fiscal year 2010, the Secretary shall ensure, subject to clauses (ii) through
p.001493: (iv), that the total for a State of the grant pursuant to paragraph (1) and the grant pursuant to subparagraph (F) is
p.001493: not less than 95 percent of such total for the State for fiscal year 2009.
p.001493: (II) RULE OF CONSTRUCTION.—With respect to the application of subclause (I), the 95 percent re- quirement under
p.001493: such subclause shall apply with respect to each grant awarded under paragraph
p.001493: (1) and with respect to each grant awarded under subparagraph (F).
p.001493: (ii) FISCAL YEARS 2011 AND 2012.—For each of the fiscal years 2011 and 2012, the Secretary shall ensure that
p.001493: the total for a State of the grant pursuant to paragraph (1) and the grant pursuant to subparagraph
...

p.001499: canceled, except that the availability of the funds for such grants is subject to section 2618(a)(2)(H)
p.001499: as applied for such year.
p.001499: (4) CORRESPONDING REDUCTION IN FUTURE GRANT.—
p.001499: (A) IN GENERAL.—In the case of a State for which a balance from a grant award made pursuant to
p.001499: section 2618(a)(1) or 2618(a)(2)(F)(i) is unobligated as of the end of the grant year for the award—
p.001499: (i) the Secretary shall reduce, by the same amount as such unobligated balance (less any amount of such balance
p.001499: that is the subject of a waiver of cancellation under paragraph (1)), the amount of the grant under
p.001499: such section for the first fiscal year beginning after the fiscal year in which the Secretary obtains
p.001499: the in- formation necessary for determining that such balance was unobligated as of the end of the grant year (which
p.001499: requirement for a reduction applies without regard to whether a waiver under paragraph (1) has been ap-
p.001499: proved with respect to such balance); and
p.001499: (ii) the grant funds involved in such reduction shall be made available by the Secretary as additional funds for
p.001499: grants under section 2620 for such first fiscal year, subject to section 2618(a)(2)(H);
p.001499: except that this subparagraph does not apply to the State if the amount of the unobligated balance was 5 percent or
p.001499: less.
p.001499: (B) RELATION TO INCREASES IN GRANT.—A reduction under subparagraph (A) for a State for a fiscal year
p.001499: may not be taken into account in applying section 2618(a)(2)(H) with respect to the State for the subsequent fiscal
p.001499: year.
p.001499: (d) TREATMENT OF DRUG REBATES.—For purposes of this sec- tion, funds that are drug rebates referred to in
p.001499: section 2616(g) may not be considered part of any grant award referred to in subsection (a). If an expenditure of
p.001499: ADAP rebate funds would trigger a pen- alty under this section or a higher penalty than would otherwise
p.001499: have applied, the State may request that for purposes of this sec- tion, the Secretary deem the State’s
p.001499: unobligated balance to be re- duced by the amount of rebate funds in the proposed expenditure.
p.001499: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001499:
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p.001501: 1501
p.001501: PUBLIC HEALTH SERVICE ACT
p.001501: Sec. 2623
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p.001501: January 30, 2020
p.001501: Notwithstanding 2618(a)(2)(F), any unobligated amount under sec- tion 2618(a)(2)(F)(ii)(V) that is returned to
p.001501: the Secretary for re- allocation shall be used by the Secretary for—
...

p.001505: (2) EARLY INTERVENTION SERVICES.—An applicant for a grant under subsection (a) shall expend not less
p.001505: than 50 per- cent of the amount received under the grant for the services described in subparagraphs (B)
p.001505: through (E) of subsection (e)(1) for individuals with HIV/AIDS.
p.001505: (c) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001505: (1) IN GENERAL.—With respect to a grant under subsection
p.001505: (a) to an applicant for a fiscal year, the applicant shall, of the portion of the grant remaining after reserving
p.001505: amounts for pur- poses of paragraphs (3) and (5) of section 2664(g), use not less than 75 percent to provide core
p.001505: medical services that are need- ed in the area involved for individuals with HIV/AIDS who are identified and eligible
p.001505: under this title (including services re- garding the co-occurring conditions of the individuals).
p.001505: (2) WAIVER.—
p.001505: (A) The Secretary shall waive the application of para- graph (1) with respect to an applicant for a grant if
p.001505: the
p.001505: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001505:
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p.001505:
p.001505:
p.001507: 1507
p.001507: PUBLIC HEALTH SERVICE ACT
p.001507: Sec. 2651
p.001507:
p.001507: Secretary determines that, within the service area of the applicant—
p.001507: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001507: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001507: this title.
p.001507: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing an applicant that a grant under subsection (a) is being
p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
p.001507:
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p.001507:
p.001507: January 30, 2020
p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
...

p.001507: (ii) subparagraphs (B) and (C) of section 2652(a)(1) shall ensure the availability of early intervention serv- ices
p.001507: through a system of linkages to community-based primary care providers, and to establish mechanisms for the
p.001507: referrals described in paragraph (1)(C), and for follow-up concerning such referrals.
p.001507: SEC. 2652. ø300ff–52¿ MINIMUM QUALIFICATIONS OF GRANTEES.
p.001507: (a) ELIGIBLE ENTITIES.—
p.001507: (1) IN GENERAL.—The entities referred to in section 2651(a) are public entities and nonprofit private entities that
p.001507: are—
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001507:
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p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
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p.001509:
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p.001509: January 30, 2020
p.001509:
p.001509: (B) A determination by the Secretary of whether an entity referred to in subparagraph (A) meets the
p.001509: criteria for a waiver under such subparagraph shall be made with- out regard to whether the entity accepts
p.001509: voluntary dona- tions regarding the provision of services to the public.
p.001509: SEC. 2653. ø300ff–53¿ PREFERENCES IN MAKING GRANTS.
p.001509: (a) IN GENERAL.—In making grants under section 2651, the Secretary shall give preference to any qualified
p.001509: applicant experi- encing an increase in the burden of providing services regarding HIV/AIDS, as indicated
p.001509: by the factors specified in subsection (b).
p.001509: (b) SPECIFICATION OF FACTORS.—
p.001509: (1) IN GENERAL.—In the case of the geographic area with respect to which the entity involved is
p.001509: applying for a grant under section 2651, the factors referred to in subsection (a), as determined for the period
p.001509: specified in paragraph (2), are—
p.001509: (A) the number of cases of HIV/AIDS;
p.001509: (B) the rate of increase in such cases;
p.001509: (C) the lack of availability of early intervention serv- ices;
p.001509: (D) the number of other cases of sexually transmitted diseases, and the number of cases of tuberculosis
p.001509: and of drug abuse and the number of cases of individuals co-in- fected with HIV/AIDS and hepatitis B or C;
p.001509: (E) the rate of increase in each of the cases specified in subparagraph (D);
p.001509: (F) the lack of availability of primary health services from providers other than such applicant; and
p.001509: (G) the distance between such area and the nearest community that has an adequate level of availability of ap-
p.001509: propriate HIV-related services, and the length of time re- quired to travel such distance.
p.001509: (2) RELEVANT PERIOD OF TIME.—The period referred to in paragraph (1) is the 2-year period preceding the fiscal
p.001509: year for which the entity involved is applying to receive a grant under section 2651.
p.001509: (c) EQUITABLE ALLOCATIONS.—In providing preferences for pur- poses of subsection (b), the Secretary shall
p.001509: equitably allocate the preferences among urban and rural areas.
p.001509: (d) CERTAIN AREAS.—Of the applicants who qualify for pref- erence under this section—
p.001509: (1) the Secretary shall give preference to applicants that will expend the grant under section 2651 to
p.001509: provide early intervention under such section in rural areas; and
p.001509: (2) the Secretary shall give preference to areas that are underserved with respect to such services.
p.001509: SEC. 2654. ø300ff–54¿ MISCELLANEOUS PROVISIONS.
p.001509: (a) SERVICES FOR INDIVIDUALS WITH HEMOPHILIA.—In making grants under section 2651, the Secretary shall
p.001509: ensure that any such grants made regarding the provision of early intervention services to individuals with
...

p.001517: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001517: SEC. 2666. ø300ff–66¿ PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
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p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (2) EMERGENCY PERIOD.—The term ‘‘emergency period’’ means the period in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (c) UNOBLIGATED FUNDS.—If funds under a grant under this section are not expended for an emergency in
p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
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p.001557: cancer or other life-threatening disease or condition and is described in any of the following subpara-
p.001557: graphs:
p.001557: (A) FEDERALLY FUNDED TRIALS.—The study or inves- tigation is approved or funded (which may include funding
p.001557: through in-kind contributions) by one or more of the fol- lowing:
p.001557:
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p.001557: January 30, 2020
p.001557: (i) The National Institutes of Health.
p.001557: (ii) The Centers for Disease Control and Preven- tion.
p.001557: (iii) The Agency for Health Care Research and Quality.
p.001557: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001557:
p.001557:
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p.001557:
p.001559: 1559
p.001559: PUBLIC HEALTH SERVICE ACT
p.001559: Sec. 2709
p.001559:
p.001559: (iv) The Centers for Medicare & Medicaid Serv- ices.
p.001559: (v) cooperative group or center of any of the enti- ties described in clauses (i) through (iv) or the Depart-
p.001559: ment of Defense or the Department of Veterans Af- fairs.
p.001559: (vi) A qualified non-governmental research entity identified in the guidelines issued by the National In- stitutes
p.001559: of Health for center support grants.
p.001559: (vii) Any of the following if the conditions de- scribed in paragraph (2) are met:
p.001559: (I) The Department of Veterans Affairs.
p.001559: (II) The Department of Defense.
p.001559: (III) The Department of Energy.
p.001559: (B) The study or investigation is conducted under an investigational new drug application reviewed by the Food
p.001559: and Drug Administration.
p.001559: (C) The study or investigation is a drug trial that is exempt from having such an investigational new
p.001559: drug ap- plication.
p.001559: (2) CONDITIONS FOR DEPARTMENTS.—The conditions de- scribed in this paragraph, for a study or
p.001559: investigation con- ducted by a Department, are that the study or investigation has been reviewed and
p.001559: approved through a system of peer re- view that the Secretary determines—
p.001559: (A) to be comparable to the system of peer review of studies and investigations used by the National
p.001559: Institutes of Health, and
p.001559: (B) assures unbiased review of the highest scientific standards by qualified individuals who have no interest in
p.001559: the outcome of the review.
p.001559: (e) LIFE-THREATENING CONDITION DEFINED.—In this section, the term ‘‘life-threatening condition’’ means any
p.001559: disease or condi- tion from which the likelihood of death is probable unless the course of the disease or
p.001559: condition is interrupted.
p.001559: (f) CONSTRUCTION.—Nothing in this section shall be construed to limit a plan’s or issuer’s coverage
p.001559: with respect to clinical trials.
p.001559: (g) APPLICATION TO FEHBP.—Notwithstanding any provision of chapter 89 of title 5, United States Code, this
p.001559: section shall apply to health plans offered under the program under such chapter.
p.001559: (h) PREEMPTION.—Notwithstanding any other provision of this Act, nothing in this section shall preempt
p.001559: State laws that require a clinical trials policy for State regulated health insurance plans that is in
p.001559: addition to the policy required under this section.
p.001559: SEC. 2709. ø300gg–9¿ DISCLOSURE OF INFORMATION.
p.001559: (a) DISCLOSURE OF INFORMATION BY HEALTH PLAN ISSUERS.— In connection with the offering of any health insurance
p.001559: coverage to a small employer or an individual, a health insurance issuer—
...

p.001563: co- insurance, co-payment, out-of-pocket limit, preferred provider, non-preferred provider, out-of-network
p.001563: co-payments, UCR (usual, customary and reasonable) fees, excluded services, grievance and appeals,
p.001563: and such other terms as the Secretary determines are important to define so that consumers may compare
p.001563: health insurance coverage and understand the terms of their coverage.
p.001563: (3) MEDICAL TERMS.—The medical terms described in this paragraph are hospitalization, hospital outpatient
p.001563: care, emer-
p.001563: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001563:
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p.001563:
p.001565: 1565
p.001565: PUBLIC HEALTH SERVICE ACT
p.001565: Sec. 2717
p.001565:
p.001565:
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p.001565:
p.001565:
p.001565: January 30, 2020
p.001565: gency room care, physician services, prescription drug cov- erage, durable medical equipment, home health
p.001565: care, skilled nursing care, rehabilitation services, hospice services, emer- gency medical transportation, and
p.001565: such other terms as the Sec- retary determines are important to define so that consumers may compare the
p.001565: medical benefits offered by health insurance and understand the extent of those medical benefits (or excep- tions to
p.001565: those benefits).
p.001565: SEC. 2715A. ø300gg–15a¿ PROVISION OF ADDITIONAL INFORMATION.
p.001565: A group health plan and a health insurance issuer offering group or individual health insurance coverage
p.001565: shall comply with the provisions of section 1311(e)(3) of the Patient Protection and Affordable Care Act,
p.001565: except that a plan or coverage that is not of- fered through an Exchange shall only be required to submit the
p.001565: in- formation required to the Secretary and the State insurance com- missioner, and make such information
p.001565: available to the public.
p.001565: SEC. 2716. ø300gg–16¿ PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY COMPENSATED INDIVIDUALS.
p.001565: (a) IN GENERAL.—A group health plan (other than a self-in- sured plan) shall satisfy the requirements of
p.001565: section 105(h)(2) of the Internal Revenue Code of 1986 (relating to prohibition on dis- crimination in
p.001565: favor of highly compensated individuals).
p.001565: (b) RULES AND DEFINITIONS.—For purposes of this section—
p.001565: (1) CERTAIN RULES TO APPLY.—Rules similar to the rules contained in paragraphs (3), (4), and (8) of
p.001565: section 105(h) of such Code shall apply.
...

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p.001579:
p.001579:
p.001581: 1581
p.001581: PUBLIC HEALTH SERVICE ACT
p.001581: Sec. 2726
p.001581:
p.001581:
p.001581:
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p.001581: January 30, 2020
p.001581: quantitative treatment limitations to ensure compliance with this section, section 712 of the Employee
p.001581: Retirement Income Security Act of 1974, or section 9812 of the Inter- nal Revenue Code of 1986, as
p.001581: applicable, (and any regula- tions promulgated pursuant to such respective section), in- cluding—
p.001581: (i) examples of methods of determining appro- priate types of nonquantitative treatment limitations
p.001581: with respect to both medical and surgical benefits and mental health and substance use disorder benefits, in- cluding
p.001581: nonquantitative treatment limitations per- taining to—
p.001581: (I) medical management standards based on medical necessity or appropriateness, or whether a treatment is
p.001581: experimental or investigative;
p.001581: (II) limitations with respect to prescription drug formulary design; and
p.001581: (III) use of fail-first or step therapy protocols;
p.001581: (ii) examples of methods of determining—
p.001581: (I) network admission standards (such as credentialing); and
p.001581: (II) factors used in provider reimbursement methodologies (such as service type, geographic market, demand
p.001581: for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to
p.001581: network adequacy;
p.001581: (iii) examples of sources of information that may serve as evidentiary standards for the purposes of
p.001581: making determinations regarding the development and application of nonquantitative treatment limita-
p.001581: tions;
p.001581: (iv) examples of specific factors, and the evi- dentiary standards used to evaluate such factors, used by
p.001581: such plans or issuers in performing a nonquantita- tive treatment limitation analysis;
p.001581: (v) examples of how specific evidentiary standards may be used to determine whether treatments are con- sidered
p.001581: experimental or investigative;
p.001581: (vi) examples of how specific evidentiary stand- ards may be applied to each service category or classi- fication
p.001581: of benefits;
p.001581: (vii) examples of methods of reaching appropriate coverage determinations for new mental health or sub- stance
p.001581: use disorder treatments, such as evidence- based early intervention programs for individuals with a serious
p.001581: mental illness and types of medical manage- ment techniques;
p.001581: (viii) examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship
...

p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
p.001585: (a) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health
p.001585: insurance coverage shall—
p.001585:
p.001585:
p.001585:
p.001585:
p.001585:
p.001585: January 30, 2020
p.001585: (1) not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the
p.001585: plan or cov- erage from informing (or penalize such pharmacy for inform- ing) an enrollee of any
p.001585: differential between the enrollee’s out- of-pocket cost under the plan or coverage with respect to acqui-
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001585:
p.001585:
p.001587: 1587
p.001587: PUBLIC HEALTH SERVICE ACT
p.001587: Sec. 2722
p.001587:
p.001587: sition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or
p.001587: health insurance coverage; and
p.001587: (2) ensure that any entity that provides pharmacy benefits management services under a contract with any such
p.001587: health plan or health insurance coverage does not, with respect to such plan or coverage, restrict,
p.001587: directly or indirectly, a phar- macy that dispenses a prescription drug from informing (or pe- nalize such
p.001587: pharmacy for informing) an enrollee of any dif- ferential between the enrollee’s out-of-pocket cost under
p.001587: the plan or coverage with respect to acquisition of the drug and the amount an individual would pay for
p.001587: acquisition of the drug without using any health plan or health insurance coverage.
p.001587: (b) DEFINITION.—For purposes of this section, the term ‘‘out-of- pocket cost’’, with respect to acquisition of a
p.001587: drug, means the amount to be paid by the enrollee under the plan or coverage, in- cluding any
p.001587: cost-sharing (including any deductible, copayment, or coinsurance) and, as determined by the Secretary, any
p.001587: other ex- penditure.
p.001587: Subpart 2—Exclusion of Plans; Enforcement; Preemption 14
p.001587: SEC. 2722. 15 ø300gg–21¿ EXCLUSION OF CERTAIN PLANS.
p.001587: (a) LIMITATION ON APPLICATION OF PROVISIONS RELATING TO
p.001587: GROUP HEALTH PLANS.—
p.001587: (1) IN GENERAL.—The requirements of subparts 1 and 2 16
p.001587: shall apply with respect to group health plans only—
p.001587: (A) subject to paragraph (2), in the case of a plan that is a nonfederal governmental plan, and
p.001587: (B) with respect to health insurance coverage offered in connection with a group health plan (including
p.001587: such a plan that is a church plan or a governmental plan).
p.001587: (2) TREATMENT OF NONFEDERAL GOVERNMENTAL PLANS.—
p.001587: (A) ELECTION TO BE EXCLUDED.—Except as provided in subparagraph (D) or (E), if the plan sponsor of a non-
p.001587: federal governmental plan which is a group health plan to which the provisions of subparts 1 and 2 16 otherwise apply
p.001587: makes an election under this subparagraph (in such form and manner as the Secretary may by regulations
p.001587: pre- scribe), then the requirements of such subparts insofar as they apply directly to group health plans
p.001587: (and not merely to group health insurance coverage) shall not apply to such governmental plans for such period
p.001587: except as provided in this paragraph.
p.001587:
p.001587:
p.001587:
p.001587:
p.001587:
p.001587:
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p.001587:
p.001587: January 30, 2020
p.001587: 14 There is a subpart II (roman II) beginning with section 2711.
...

p.001625: and policies related to all-hazards medical and public health preparedness and response, including exercises
p.001625: based on—
p.001625: (i) identified threats for which countermeasures are available and for which no countermeasures are
p.001625: available; and
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001625:
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p.001627: 1627
p.001627: PUBLIC HEALTH SERVICE ACT
p.001627: Sec. 2811
p.001627:
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p.001627: January 30, 2020
p.001627: (ii) unknown threats for which no counter- measures are available.
p.001627: (H) NATIONAL SECURITY PRIORITY.—On a periodic basis consult with, as applicable and appropriate, the Assistant
p.001627: to the President for National Security Affairs, to provide an update on, and discuss, medical and public health
p.001627: pre- paredness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act,
p.001627: including progress on the development, approval, clearance, and li- censure of medical countermeasures.
p.001627: (I) THREAT AWARENESS.—Coordinate with the Director of the Centers for Disease Control and Prevention, the Di-
p.001627: rector of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Secu-
p.001627: rity Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of
p.001627: Agriculture, to maintain a current assessment of national security threats and inform preparedness and response
p.001627: capabilities based on the range of the threats that have the potential to re- sult in a public health
p.001627: emergency.
p.001627: (5) LOGISTICS.—In coordination with the Secretary of Vet- erans Affairs, the Secretary of Homeland Security, the
p.001627: General Services Administration, and other public and private entities, provide logistical support for medical and
p.001627: public health aspects of Federal responses to public health emergencies. Such logistical support shall
p.001627: include working with other relevant Federal, State, local, Tribal, and territorial public health offi-
p.001627: cials and private sector entities to identify the critical infra- structure assets, systems, and networks
p.001627: needed for the proper functioning of the health care and public health sectors that need to be maintained
p.001627: through any emergency or disaster, in- cluding entities capable of assisting with, responding to, and
...

p.001629: replenishment of the Strategic National Stockpile;
p.001629: (E) be informed by the recommendations of the Na- tional Biodefense Science Board pursuant to section 319M;
p.001629: (F) evaluate progress made in meeting timelines, allo- cations, benchmarks, and milestones identified under sub-
p.001629: paragraph (D)(ii);
p.001629: (G) report on the amount of funds available for pro- curement in the special reserve fund as defined in
p.001629: section 319F–2(h) and the impact this funding will have on meet- ing the requirements under section 319F–2;
p.001629: (H) incorporate input from Federal, State, local, and tribal stakeholders;
p.001629: (I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals
p.001629: (as de- fined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the
p.001629: projected needs for re- lated stockpiling and replenishment of the Strategic Na- tional Stockpile, including
p.001629: by addressing the needs of pedi- atric populations with respect to such countermeasures and products in the
p.001629: Strategic National Stockpile, includ- ing—
p.001629:
p.001629:
p.001629:
p.001629:
p.001629:
p.001629:
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p.001629:
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p.001629:
p.001629:
p.001629:
p.001629:
p.001629:
p.001629:
p.001629: January 30, 2020
p.001629: (i) a list of such countermeasures and products necessary to address the needs of pediatric popu-
p.001629: lations;
p.001629: (ii) a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food
p.001629: and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and
p.001629: products for pediatric populations;
p.001629: (iii) a description of existing gaps in the Strategic National Stockpile and the development of such coun- termeasures
p.001629: and products to address the needs of pe- diatric populations; and
p.001629: (iv) an evaluation of the progress made in ad- dressing priorities identified pursuant to subpara-
p.001629: graph (C);
p.001629: (J) identify the use of authority and activities under- taken pursuant to sections 319F–1(b)(1),
p.001629: 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F– 2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv),
p.001629: and 319F–2(c)(7)(C)(v) of
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001629:
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p.001629:
p.001629:
p.001631: 1631
p.001631: PUBLIC HEALTH SERVICE ACT
p.001631: Sec. 2811
p.001631:
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p.001631: January 30, 2020
p.001631: this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act,
p.001631: by sum- marizing—
p.001631: (i) the particular actions that were taken under the authorities specified, including, as applicable, the
p.001631: identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the
p.001631: authority was used;
p.001631: (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options
p.001631: that were considered and rejected with respect to the use of such authorities;
p.001631: (iii) the number of, nature of, and other informa- tion concerning the persons and entities that
p.001631: received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and
p.001631: en- tities that were considered and rejected for such a grant, cooperative agreement, or contract, except
p.001631: that the report need not disclose the identity of any such person or entity;
p.001631: (iv) whether, with respect to each procurement that is approved by the President under section 319F– 2(c)(6), a
p.001631: contract was entered into within one year after such approval by the President; and
p.001631: (v) with respect to section 319F–1(d), for the 2- year period for which the report is submitted, the
p.001631: number of persons who were paid amounts totaling
p.001631: $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less
p.001631: than $100,000; and
p.001631: (K) be made publicly available.
p.001631: (3) GAO REPORT.—
...

p.001653: from, other health information technology without special effort on the part of the user;
p.001653: (B) allows for complete access, exchange, and use of all electronically accessible health information for
p.001653: authorized use under applicable State or Federal law; and
p.001653: (C) does not constitute information blocking as defined in section 3022(a).
p.001653: (10) 1 LABORATORY.—The term ‘‘laboratory’’ has the mean- ing given such term in section 353(a).
p.001653: (11) 1 NATIONAL COORDINATOR.—The term ‘‘National Coor- dinator’’ means the head of the Office of the
p.001653: National Coordi-
p.001653:
p.001653:
p.001653:
p.001653:
p.001653:
p.001653: January 30, 2020
p.001653: 1 Subsections (a) and (e)(2)(B) of section 4003 of Public Law 114–255 provide for amendments to this section. Certain
p.001653: amendments as it relates to redesignating paragraph ranges were in con- flict with each other. The above list of
p.001653: paragraphs reflects them in the order of sequence in ac- cordance with the probable intent of Congress.
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001653:
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p.001655: 1655
p.001655: PUBLIC HEALTH SERVICE ACT
p.001655: Sec. 3001
p.001655:
p.001655: nator for Health Information Technology established under sec- tion 3001(a).
p.001655: (12) 1 PHARMACIST.—The term ‘‘pharmacist’’ has the mean- ing given such term in section 804(2) of the Federal
p.001655: Food, Drug, and Cosmetic Act.
p.001655: (13) 1 QUALIFIED ELECTRONIC HEALTH RECORD.—The term ‘‘qualified electronic health record’’ means an
p.001655: electronic record of health-related information on an individual that—
p.001655: (A) includes patient demographic and clinical health information, such as medical history and problem
p.001655: lists; and
p.001655: (B) has the capacity—
p.001655: (i) to provide clinical decision support;
p.001655: (ii) to support physician order entry;
p.001655: (iii) to capture and query information relevant to health care quality; and
p.001655: (iv) to exchange electronic health information with, and integrate such information from other
p.001655: sources.
p.001655: (14) 1 STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, Puerto Rico, the
p.001655: Virgin Is- lands, Guam, American Samoa, and the Northern Mariana Is- lands.
p.001655:
p.001655: Subtitle A—Promotion of Health Information Technology
p.001655:
p.001655: SEC. 3001. ø300jj–11¿ OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY.
p.001655: (a) ESTABLISHMENT.—There is established within the Depart- ment of Health and Human Services an Office of the
p.001655: National Co- ordinator for Health Information Technology (referred to in this section as the ‘‘Office’’).
p.001655: The Office shall be headed by a National Coordinator who shall be appointed by the Secretary and shall re- port
p.001655: directly to the Secretary.
p.001655: (b) PURPOSE.—The National Coordinator shall perform the du- ties under subsection (c) in a manner consistent
p.001655: with the develop- ment of a nationwide health information technology infrastructure that allows for the
p.001655: electronic use and exchange of information and that—
...

p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001665:
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p.001665: Sec. 3002 PUBLIC HEALTH SERVICE ACT 1666
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p.000111: C:\XML\PHSA.BEL HOUSEP
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p.000111: C:\XML\SSA-MERGED.XML
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p.000111:
p.000113: 113
p.000113: PUBLIC HEALTH SERVICE ACT
p.000113: Sec. 317D
p.000113:
p.000113: the Director of the National Center for Environmental Health that have expertise in birth defects, developmental
p.000113: disabilities, and dis- abilities and health shall be transferred to and shall advise the Na- tional Center on Birth
p.000113: Defects and Developmental Disabilities ef- fective on the date of enactment of the Birth Defects and Develop-
p.000113: mental Disabilities Prevention Act of 2003.
p.000113: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000113: to be appropriated such sums as may be necessary for each of fiscal years 2003 through 2007.
p.000113:
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p.000113: January 30, 2020
p.000113: PREVENTIVE HEALTH MEASURES WITH RESPECT TO PROSTATE CANCER
p.000113: SEC. 317D. ø247b–5¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000113: Control and Pre- vention, may make grants to States and local health departments for the purpose of
p.000113: enabling such States and departments to carry out programs that may include the following:
p.000113: (1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners
p.000113: regarding screening for prostate cancer.
p.000113: (2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National
p.000113: Institutes of Health, the effectiveness of screening strategies for prostate cancer.
p.000113: (3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the
p.000113: quality of life for men after prostrate cancer screening and followup.
p.000113: (4) To develop and disseminate public information and education programs for prostate cancer, including
p.000113: appropriate messages about the risks and benefits of prostate cancer screening for the general
p.000113: public, health care providers, policy makers and other appropriate individuals.
p.000113: (5) To improve surveillance for prostate cancer.
p.000113: (6) To address the needs of underserved and minority pop- ulations regarding prostate cancer.
p.000113: (7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Pre-
p.000113: ventive Services Task Force and shall seek input, where appro- priate, from professional societies and other private
p.000113: and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
p.000113: (A) to screen men for prostate cancer as a preventive health measure;
p.000113: (B) to provide appropriate referrals for the medical treatment of men who have been screened under subpara-
p.000113: graph (A) and to ensure, to the extent practicable, the pro- vision of appropriate followup services and support
...

p.000733: intramural laboratory and clinical research program in obstetrics and gynecology.
p.000733: CHILD HEALTH RESEARCH CENTERS
p.000733: SEC. 452C. ø285g–7¿ The Director of the Institute shall de- velop and support centers for conducting
p.000733: research with respect to child health. Such centers shall give priority to the expeditious transfer of
p.000733: advances from basic science to clinical applications and improving the care of infants and children.
p.000733:
p.000733:
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p.000733:
p.000733: January 30, 2020
p.000733:
p.000733: PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH
p.000733: SEC. 452D. ø285g–8¿ (a) IN GENERAL.—Not later than October 1, 1993, the Director of the Institute shall
p.000733: commence a study for the purpose of providing information on the general health and well-being of
p.000733: adolescents in the United States, including, with re- spect to such adolescents, information on—
p.000733: (1) the behaviors that promote health and the behaviors that are detrimental to health; and
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000733:
p.000733:
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p.000733:
p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
p.000735: monitor the sub- jects throughout the period of the study to determine the health status of the
p.000735: subjects and any change in such status over time.
p.000735: (2) POPULATION-SPECIFIC ANALYSES.—The study required in subsection (a) shall be conducted with respect to
p.000735: the popu- lation of adolescents who are female, the population of adoles- cents who are male, various
p.000735: socioeconomic populations of ado- lescents, and various racial and ethnic populations of adoles- cents. The
p.000735: study shall be designed and conducted in a manner sufficient to provide for a valid analysis of whether there
p.000735: are significant differences among such populations in health status and whether and to what extent any such
p.000735: differences are due to factors particular to the populations involved.
p.000735: (c) COORDINATION WITH WOMEN’S HEALTH INITIATIVE.—With respect to the national study of women being conducted
p.000735: by the Sec- retary and known as the Women’s Health Initiative, the Secretary shall ensure that such study is
p.000735: coordinated with the component of the study required in subsection (a) that concerns adolescent fe- males,
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p.000741: 741
p.000741: PUBLIC HEALTH SERVICE ACT
p.000741: Sec. 464C
p.000741:
p.000741: contribute important knowledge to the understanding and elimination of disorders of hearing and other
p.000741: communication processes;
p.000741: (2) research into the evaluation of techniques (including surgical, medical, and behavioral approaches) and
p.000741: devices (in- cluding hearing aids, implanted auditory and nonauditory prosthetic devices and other
p.000741: communication aids) used in diag- nosis, treatment, rehabilitation, and prevention of disorders of hearing and other
p.000741: communication processes;
p.000741: (3) research into prevention, and early detection and diag- nosis, of hearing loss and speech and language
p.000741: disturbances (including stuttering) and research into preventing the effects of such disorders on learning and
p.000741: learning disabilities with ex- tension of programs for appropriate referral and rehabilitation;
p.000741: (4) research into the detection, treatment, and prevention of disorders of hearing and other communication
p.000741: processes in the growing elderly population with extension of rehabilitative programs to ensure continued effective
p.000741: communication skills in such population;
p.000741: (5) research to expand knowledge of the effects of environ- mental agents that influence hearing or other
p.000741: communication processes; and
p.000741: (6) developing and facilitating intramural programs on clinical and fundamental aspects of disorders of hearing
p.000741: and all other communication processes.
p.000741: DATA SYSTEM AND INFORMATION CLEARINGHOUSE
p.000741: SEC. 464B. ø285m–2¿ (a) The Director of the Institute shall es- tablish a National Deafness and Other
p.000741: Communication Disorders Data System for the collection, storage, analysis, retrieval, and dis- semination of data
p.000741: derived from patient populations with disorders of hearing or other communication processes, including where pos-
p.000741: sible, data involving general populations for the purpose of identi- fying individuals at risk of developing
p.000741: such disorders.
p.000741: (b) The Director of the Institute shall establish a National Deafness and Other Communication Disorders
p.000741: Information Clear- inghouse to facilitate and enhance, through the effective dissemina- tion of information,
p.000741: knowledge and understanding of disorders of hearing and other communication processes by health
p.000741: profes- sionals, patients, industry, and the public.
p.000741:
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p.000741: January 30, 2020
p.000741: MULTIPURPOSE DEAFNESS AND OTHER COMMUNICATION DISORDERS CENTER
p.000741: SEC. 464C. ø285m–3¿ (a) The Director of the Institute shall, after consultation with the advisory council
p.000741: for the Institute, pro- vide for the development, modernization, and operation (including care required
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p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were
p.000001: all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan
p.000001: abolished the National Institutes of Health as an agency, it did not abolish the individual research
p.000001: institutes.
p.000001: In 1985, Public Law 99–158 added title IV of this Act, which provides that the National Insti- tutes of Health is an
p.000001: agency of the Public Health Service. See section 401(a).
p.000001: Other laws have established additional agencies within the Service. Section 501(a) of this Act provides that the
p.000001: Substance Abuse and Mental Health Services Administration is an agency of the Service. Section 901(a) establishes
p.000001: the Agency for Healthcare Research and Quality within the Service (formerly designated as the Agency for Health
p.000001: Care Policy and Research).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 3 PUBLIC HEALTH SERVICE ACT Sec. 203
p.000001:
p.000001: Bureau of Medical Services, and (4) the Bureau of State Services, and the Agency for Health Care Policy
p.000001: and Research. 2 The Sec- retary is authorized and directed to assign to the Office of the Sec- retary, to the
p.000001: National Institutes of Health, to the Bureau of Med- ical Services, and to the Bureau of State Services, respectively,
p.000001: the several functions of the Service, and to establish within them such divisions, sections and other units as he
p.000001: may find necessary; and from time to time, abolish, transfer, and consolidate divisions, sec- tions, and other
p.000001: units and assign their functions and personnel in such manner as he may find necessary for efficient operation
p.000001: of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated,
p.000001: except with the approval of the Secretary. The National Institutes of Health shall be adminis- tered as a
...

p.000001: (ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of paragraph (6), if an
p.000001: estimate under sub- paragraph (C) of such paragraph has not been made for the cal- endar year beginning
p.000001: in such fiscal year, the transfer under sub- paragraph (D) of such paragraph shall be made
p.000001: notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount
p.000001: of such appropriation.
p.000001: (p) ADMINISTRATION OF SMALLPOX COUNTERMEASURES BY
p.000001: HEALTH PROFESSIONALS.—
p.000001: (1) IN GENERAL.—For purposes of this section, and subject to other provisions of this subsection, a covered person
p.000001: shall be deemed to be an employee of the Public Health Service with respect to liability arising out of
p.000001: administration of a covered countermeasure against smallpox to an individual during the effective period of
p.000001: a declaration by the Secretary under para- graph (2)(A).
p.000001: (2) DECLARATION BY SECRETARY CONCERNING COUNTER- MEASURE AGAINST SMALLPOX.—
p.000001: (A) AUTHORITY TO ISSUE DECLARATION.—
p.000001: (i) IN GENERAL.—The Secretary may issue a dec- laration, pursuant to this paragraph, concluding that an
p.000001: actual or potential bioterrorist incident or other ac- tual or potential public health emergency makes ad-
p.000001: visable the administration of a covered counter- measure to a category or categories of individuals.
p.000001: (ii) COVERED COUNTERMEASURE.—The Secretary shall specify in such declaration the substance or sub- stances
p.000001: that shall be considered covered counter- measures (as defined in paragraph (7)(A)) for purposes of
p.000001: administration to individuals during the effective period of the declaration.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 37 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: (iii) EFFECTIVE PERIOD.—The Secretary shall specify in such declaration the beginning and ending
p.000001: dates of the effective period of the declaration, and may subsequently amend such declaration to shorten
p.000001: or extend such effective period, provided that the new closing date is after the date when the declaration is
p.000001: amended.
p.000001: (iv) PUBLICATION.—The Secretary shall promptly publish each such declaration and amendment in the Federal
p.000001: Register.
p.000001: (B) LIABILITY OF UNITED STATES ONLY FOR ADMINISTRA- TIONS WITHIN SCOPE OF DECLARATION.—Except as provided in
p.000001: paragraph (5)(B)(ii), the United States shall be liable under this subsection with respect to a claim
p.000001: arising out of the administration of a covered countermeasure to an individual only if—
p.000001: (i) the countermeasure was administered by a qualified person, for a purpose stated in paragraph
p.000001: (7)(A)(i), and during the effective period of a declara- tion by the Secretary under subparagraph (A) with re-
p.000001: spect to such countermeasure; and
...

p.000001: (A) IN GENERAL.—Should payment be made by the United States to any claimant bringing a claim under this
p.000001: subsection, either by way of administrative determination, settlement, or court judgment, the United States
p.000001: shall have, notwithstanding any provision of State law, the right to recover for that portion of the damages so
p.000001: awarded or paid, as well as interest and any costs of litigation, result- ing from the failure of any covered person
p.000001: to carry out any obligation or responsibility assumed by such person under a contract with the United States or from
p.000001: any grossly neg- ligent, reckless, or illegal conduct or willful misconduct on the part of such person.
p.000001: (B) VENUE.—The United States may maintain an ac- tion under this paragraph against such person in the
p.000001: dis- trict court of the United States in which such person re- sides or has its principal place of business.
p.000001: (7) DEFINITIONS.—As used in this subsection, terms have the following meanings:
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 40
p.000001:
p.000001: (A) COVERED COUNTERMEASURE.—The term ‘‘covered countermeasure’’ or ‘‘covered countermeasure against
p.000001: smallpox’’, means a substance that is—
p.000001: (i)(I) used to prevent or treat smallpox (including the vaccinia or another vaccine); or
p.000001: (II) 12 used to control or treat the adverse ef- fects of vaccinia inoculation or of administration of another
p.000001: covered countermeasure; and
p.000001: (ii) specified in a declaration under paragraph (2).
p.000001: (B) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration of a covered
p.000001: countermeasure, means a person who is—
p.000001: (i) a manufacturer or distributor of such counter- measure;
p.000001: (ii) a health care entity under whose auspices 13—
p.000001: (I) such countermeasure was administered;
p.000001: (II) a determination was made as to whether, or under what circumstances, an individual should receive a
p.000001: covered countermeasure;
p.000001: (III) the immediate site of administration on the body of a covered countermeasure was mon- itored,
p.000001: managed, or cared for; or
p.000001: (IV) an evaluation was made of whether the administration of a countermeasure was effective;
p.000001: (iii) a qualified person who administered such countermeasure;
p.000001: (iv) a State, a political subdivision of a State, or an agency or official of a State or of such a
p.000001: political subdivision, if such State, subdivision, agency, or offi- cial has established requirements,
p.000001: provided policy guidance, supplied technical or scientific advice or as- sistance, or otherwise supervised
p.000001: or administered a program with respect to administration of such coun- termeasures;
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p.000017: (3) The Secretary shall conduct and may support through grants and contracts research and studies on
p.000017: human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and
p.000017: on the maintenance and promotion of health, and programs for the dissemination of information re- specting
p.000017: human nutrition to health professionals and the public. In carrying out activities under this paragraph, the
p.000017: Secretary shall provide for the coordination of such of these activities as are per- formed by the
p.000017: different divisions within the Department of Health, Education, and Welfare and shall consult with entities of the Fed-
p.000017: eral Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activities. The
p.000017: Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses,
p.000017: may conduct and support such activities for such entity.
p.000017: (4) The Secretary shall publish a biennial report which con- tains—
p.000017: (A) a list of all substances (i) which either are known to
p.000017: be carcinogens or may reasonably be anticipated to be carcino- gens and (ii) to which a significant number of persons
p.000017: residing in the United States are exposed;
p.000017: (B) information concerning the nature of such exposure and the estimated number of persons exposed to
p.000017: such sub- stances;
p.000017: (C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent,
p.000017: ambient, or exposure standard has been established by a Federal agen- cy, and (ii) for each effluent, ambient,
p.000017: or exposure standard es- tablished by a Federal agency with respect to a substance con- tained in the list under
p.000017: subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard,
p.000017: and the implementation of such standard by the agency, decreases the risk to public health from exposure
p.000017: to the substance; and
p.000017: (D) a description of (i) each request received during the year involved—
p.000017:
p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
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p.000017: 75 PUBLIC HEALTH SERVICE ACT Sec. 301
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p.000017: January 30, 2020
p.000017: (I) from a Federal agency outside the Department of Health, Education, and Welfare for the Secretary, or
p.000017: (II) from an entity within the Department of Health, Education, and Welfare to any other entity within the De-
p.000017: partment,
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p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: 127
p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
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p.000129: Sec. 317L PUBLIC HEALTH SERVICE ACT 130
p.000129:
p.000129: (1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the
p.000129: Indian Self- Determination and Education Assistance Act;
p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: January 30, 2020
p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: 131
p.000131: PUBLIC HEALTH SERVICE ACT
p.000131: Sec. 317L–1
p.000131:
p.000131: (C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
p.000131: (b) GRANTS.—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States,
p.000131: local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and
p.000131: other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties.
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p.000131: January 30, 2020
p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
p.000131: (1) provide technical and consultative assistance to entities receiving grants under subsection (b);
p.000131: (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease
p.000131: Control and Pre- vention;
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p.000135: the in- cidence of infections commonly associated with illicit drug use, such as viral hepatitis, human
p.000135: immunodeficiency virus, and in- fective endocarditis, and to assist the States in determining the prevalence of such
p.000135: infections, which may include the reporting of cases of such infections.
p.000135: (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph
p.000135: (1) result- ing from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
p.000135: (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified
p.000135: under para- graph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
p.000135: (4) To develop and disseminate public information and education programs for the detection and control of
p.000135: infections described in paragraph (1), with priority given to high-risk populations as determined by the
p.000135: Secretary.
p.000135: (5) To improve the education, training, and skills of health professionals in the detection and control of
p.000135: infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use
p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
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p.000135: January 30, 2020
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p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000247: (D) TRANSCRIPT.—The Secretary shall maintain a com- plete verbatim transcript of each meeting or consultation
p.000247: conducted under this subsection. Such transcript (or a por- tion thereof) shall not be disclosed under section
p.000247: 552 of title 5, United States Code, to the extent that the Sec- retary, in consultation with the
p.000247: Attorney General and the Secretary of Homeland Security, determines that disclo- sure of such transcript
p.000247: (or portion thereof) would pose a threat to national security. The transcript (or portion thereof)
p.000247: with respect to which the Secretary has made such a determination shall be deemed to be information
p.000247: described in subsection (b)(3) of such section 552.
p.000247: (E) EXEMPTION.—
p.000247: (i) IN GENERAL.—Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to
p.000247: participate in a meeting or consultation conducted in accordance with this paragraph.
p.000247: (ii) LIMITATION.—Clause (i) shall not apply to any agreement or conduct that results from a meeting or
p.000247: consultation and that is not covered by an exemption granted under paragraph (4).
p.000247: (2) SUBMISSION OF WRITTEN AGREEMENTS.—The Secretary shall submit each written agreement regarding covered
p.000247: activi- ties that is made pursuant to meetings or consultations con- ducted under paragraph (1) to the
p.000247: Attorney General and the Chairman for consideration. In addition to the proposed agree- ment itself, any submission
p.000247: shall include—
p.000247: (A) an explanation of the intended purpose of the agreement;
p.000247: (B) a specific statement of the substance of the agree- ment;
p.000247: (C) a description of the methods that will be utilized to achieve the objectives of the agreement;
p.000247: (D) an explanation of the necessity for a cooperative effort among the particular participating
p.000247: persons to achieve the objectives of the agreement; and
p.000247: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000247: Sec. 319L–1 PUBLIC HEALTH SERVICE ACT 248
p.000247:
p.000247: (E) any other relevant information determined nec- essary by the Attorney General, in consultation with
p.000247: the Chairman and the Secretary.
p.000247: (3) EXEMPTION FOR CONDUCT UNDER APPROVED AGREE- MENT.—It shall not be a violation of the antitrust
p.000247: laws for a person to engage in conduct in accordance with a written agreement to the extent that such
p.000247: agreement has been granted an exemption under paragraph (4), during the period for which the exemption is in effect.
p.000247: (4) ACTION ON WRITTEN AGREEMENTS.—
p.000247: (A) IN GENERAL.—The Attorney General, in consulta- tion with the Chairman, shall grant, deny, grant in
p.000247: part and deny in part, or propose modifications to an exemption request regarding a written agreement submitted
p.000247: under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such
p.000247: request. An exemption granted under this paragraph shall take effect immediately.
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p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
p.000259: (B) recuperative care services;
p.000259: (C) environmental health services, including—
p.000259: (i) the detection and alleviation of unhealthful conditions associated with—
p.000259: (I) water supply;
p.000259: (II) chemical and pesticide exposures;
p.000259: (III) air quality; or
p.000259: (IV) exposure to lead;
p.000259: (ii) sewage treatment;
p.000259: (iii) solid waste disposal;
p.000259: (iv) rodent and parasitic infestation;
p.000259: (v) field sanitation;
p.000259: (vi) housing; and
p.000259: (vii) other environmental factors related to health;
p.000259:
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p.000259: January 30, 2020
p.000259: and
p.000259: (D) in the case of health centers receiving grants under subsection (g), special
p.000259: occupation-related health services for migratory and seasonal agricultural workers, including—
p.000259: (i) screening for and control of infectious diseases, including parasitic diseases; and
p.000259: (ii) injury prevention programs, including preven- tion of exposure to unsafe levels of agricultural chemi- cals
p.000259: including pesticides.
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: Sec. 330 PUBLIC HEALTH SERVICE ACT 260
p.000259:
p.000259: (3) MEDICALLY UNDERSERVED POPULATIONS.—
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p.000263: the applicants involved to the medically underserved populations in urban areas which may be expected to
p.000263: use the services provided by the applicants is not less than two to three or greater than three to two.
p.000263: (iv) SERVICE AREA OVERLAP.—If in carrying out clause (i) the applicant proposes to serve an area that is
p.000263: currently served by another health center funded under this section, the Secretary may consider wheth- er the
p.000263: award of funding to an additional health center in the area can be justified based on the unmet need for
p.000263: additional services within the catchment area.
p.000263: (B) APPROVAL OF EXPANDED SERVICE APPLICATIONS.—
p.000263: (i) IN GENERAL.—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph
p.000263: (1) to expand the capacity of the applicant to provide required primary health services described in
p.000263: subsection (b)(1) or additional health services de- scribed in subsection (b)(2).
p.000263: (ii) PRIORITY EXPANSION PROJECTS.—In carrying out clause (i), the Secretary may give special consider- ation to
p.000263: expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health,
p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
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p.000265: (ii) the production, cultivation, growing, and har- vesting of any commodity grown on, in, or as an ad-
p.000265: junct to or part of a commodity grown in or on, the land; and
p.000265: (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to
p.000265: carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an
p.000265: activity described in clause (ii).
p.000265: (h) HOMELESS POPULATION.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of homeless
p.000265: individuals, including grants for innovative programs that provide outreach and com- prehensive primary health
p.000265: services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and
p.000265: veterans at risk of homelessness.
p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
p.000265: (A) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ means an individual who lacks housing (without
p.000265: regard to whether the individual is a member of a family), including an individual whose primary residence during
p.000265: the night is a supervised public or private facility that pro- vides temporary living accommodations and an
p.000265: individual who is a resident in transitional housing.
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000267: PUBLIC HEALTH SERVICE ACT
p.000267: Sec. 330
p.000267:
p.000267: (B) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘substance abuse 31services’’ includes detoxification,
p.000267: risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse 31 provided
p.000267: in settings other than hospitals.
p.000267: (i) RESIDENTS OF PUBLIC HOUSING.—
p.000267: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000267: the plan- ning and delivery of services to a special medically under- served population comprised of
p.000267: residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term
p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
p.000267: (2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under this subsection shall be expended to supplement, and not
p.000267: sup- plant, the expenditures of the health center and the value of in kind contributions for the
p.000267: delivery of services to the popu- lation described in paragraph (1).
p.000267: (3) CONSULTATION WITH RESIDENTS.—The Secretary may not make a grant under paragraph (1) unless, with
p.000267: respect to the residents of the public housing involved, the applicant for the grant—
p.000267: (A) has consulted with the residents in the prepara- tion of the application for the grant; and
p.000267: (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the
p.000267: program carried out with the grant.
p.000267: (j) ACCESS GRANTS.—
p.000267: (1) IN GENERAL.—The Secretary may award grants to eligi- ble health centers with a substantial number of
p.000267: clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services
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p.000351: Sec. 340 PUBLIC HEALTH SERVICE ACT 352
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p.000351: January 30, 2020
p.000351:
p.000351: the medicare, medicaid, and State child health insurance programs and to patients who pay privately for
p.000351: services;
p.000351: (C) describes the activities that the applicant and the consortium propose to perform under the grant to
p.000351: further the objectives of this section;
p.000351: (D) demonstrates the consortium’s ability to build on the current system (as of the date of submission of the
p.000351: ap- plication) for serving a community or geographic area of uninsured and underinsured individuals by
p.000351: involving pro- viders who have traditionally provided a significant vol- ume of care for that community;
p.000351: (E) demonstrates the consortium’s ability to develop coordinated systems of care that either directly provide or
p.000351: ensure the prompt provision of a broad range of high-qual- ity, accessible services, including, as appropriate,
p.000351: primary, secondary, and tertiary services, as well as substance abuse treatment and mental health
p.000351: services in a manner that assures continuity of care in the community or geo- graphic area;
p.000351: (F) provides evidence of community involvement in the development, implementation, and direction of the pro- gram
p.000351: that the entity proposes to operate;
p.000351: (G) demonstrates the consortium’s ability to ensure that individuals participating in the program are
p.000351: enrolled in public insurance programs for which the individuals are eligible or know of private insurance
p.000351: programs where available;
p.000351: (H) presents a plan for leveraging other sources of rev- enue, which may include State and local sources and
p.000351: pri- vate grant funds, and integrating current and proposed new funding sources in a way to assure long-term
p.000351: sustain- ability of the program;
p.000351: (I) describes a plan for evaluation of the activities car- ried out under the grant, including measurement
p.000351: of progress toward the goals and objectives of the program and the use of evaluation findings to improve
p.000351: program per- formance;
p.000351: (J) demonstrates fiscal responsibility through the use of appropriate accounting procedures and
p.000351: appropriate management systems;
p.000351: (K) demonstrates the consortium’s commitment to serve the community without regard to the ability of an in-
p.000351: dividual or family to pay by arranging for or providing free or reduced charge care for the poor; and
p.000351: (L) includes such other information as the Secretary may prescribe.
p.000351: (c) LIMITATIONS.—
p.000351: (1) NUMBER OF AWARDS.—
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p.000353: (i) natural disasters or other major disruptions to the security or health of the community or geographic area
p.000353: served by the eligible entity; or
p.000353: (ii) a significant economic deterioration in the community or geographic area served by such
p.000353: eligible entity, that directly and adversely affects the entity receiving an award under subsection (a).
p.000353: (d) PRIORITIES.—In awarding grants under this section, the Secretary—
p.000353: (1) shall accord priority to applicants that demonstrate the extent of unmet need in the community involved for a more
p.000353: co- ordinated system of care; and
p.000353: (2) may accord priority to applicants that best promote the objectives of this section, taking into consideration
p.000353: the extent to which the application involved—
p.000353: (A) identifies a community whose geographical area has a high or increasing percentage of individuals who are
p.000353: uninsured;
p.000353: (B) demonstrates that the applicant has included in its consortium providers, support systems, and programs that have
p.000353: a tradition of serving uninsured individuals and underinsured individuals in the community;
p.000353: (C) shows evidence that the program would expand utilization of preventive and primary care services for un-
p.000353: insured and underinsured individuals and families in the community, including behavioral and mental health
p.000353: serv- ices, oral health services, or substance abuse services;
p.000353: (D) proposes a program that would improve coordina- tion between health care providers and appropriate
p.000353: social service providers;
p.000353: (E) demonstrates collaboration with State and local governments;
p.000353: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000353: Sec. 340 PUBLIC HEALTH SERVICE ACT 354
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p.000353:
p.000353: (F) demonstrates that the applicant makes use of non-
p.000353: Federal contributions to the greatest extent possible; or
p.000353: (G) demonstrates a likelihood that the proposed pro- gram will continue after support under this section ceases.
p.000353: (e) USE OF FUNDS.—
p.000353: (1) USE BY GRANTEES.—
p.000353: (A) IN GENERAL.—Except as provided in paragraphs
p.000353: (2) and (3), a grantee may use amounts provided under this section only for—
p.000353: (i) direct expenses associated with achieving the greater integration of a health care delivery system so that
p.000353: the system either directly provides or ensures the provision of a broad range of culturally competent services,
p.000353: as appropriate, including primary, secondary, and tertiary services, as well as substance abuse treat- ment and mental
p.000353: health services; and
p.000353: (ii) direct patient care and service expansions to fill identified or documented gaps within an integrated
p.000353: delivery system.
p.000353: (B) SPECIFIC USES.—The following are examples of purposes for which a grantee may use grant funds under
p.000353: this section, when such use meets the conditions stated in subparagraph (A):
p.000353: (i) Increases in outreach activities and closing gaps in health care service.
p.000353: (ii) Improvements to case management.
p.000353: (iii) Improvements to coordination of transpor- tation to health care facilities.
p.000353: (iv) Development of provider networks and other innovative models to engage physicians in voluntary efforts
p.000353: to serve the medically underserved within a community.
p.000353: (v) Recruitment, training, and compensation of necessary personnel.
p.000353: (vi) Acquisition of technology for the purpose of co- ordinating care.
p.000353: (vii) Improvements to provider communication, in- cluding implementation of shared information systems or shared
p.000353: clinical systems.
p.000353: (viii) Development of common processes for deter- mining eligibility for the programs provided through the
p.000353: system, including creating common identification cards and single sliding scale discounts.
p.000353: (ix) Development of specific prevention and dis- ease management tools and processes.
p.000353: (x) Translation services.
p.000353: (xi) Carrying out other activities that may be ap- propriate to a community and that would increase ac- cess
...

p.000469: para- graph (2);
p.000469: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000469: out such activity; and
p.000469: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity.
p.000469: (2) EVIDENCE-BASED PREVENTION ACTIVITIES.—An evidence- based prevention activity described in this paragraph is any
p.000469: of the following activities:
p.000469: (A) Improving the efficiency and use of a new or cur- rently operating prescription drug monitoring program,
p.000469: in- cluding by—
p.000469: (i) encouraging all authorized users (as specified by the State or other entity) to register with and
p.000469: use the program;
p.000469: (ii) enabling such users to access any updates to information collected by the program in as close to
p.000469: real-time as possible;
p.000469: (iii) improving the ease of use of such program;
p.000469: (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of
p.000469: controlled substances and any detection of in- appropriate prescribing or dispensing practices relat- ing to such
p.000469: substances;
p.000469: (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identi-
p.000469: fied, aggregate reports based on such analysis to State public health agencies, State substance abuse agen- cies,
p.000469: State licensing boards, and other appropriate
p.000469: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: 471
p.000471: PUBLIC HEALTH SERVICE ACT
p.000471: Sec. 392A
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p.000471: State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug
p.000471: monitoring program and not containing any protected health information, to prevent inappropriate pre-
p.000471: scribing, drug diversion, or abuse and misuse of con- trolled substances, and to facilitate better coordination
p.000471: among agencies;
p.000471: (vi) enhancing interoperability between the pro- gram and any health information technology (includ- ing
p.000471: certified health information technology), including by integrating program data into such technology;
p.000471: (vii) updating program capabilities to respond to technological innovation for purposes of appropriately
p.000471: addressing the occurrence and evolution of controlled substance overdoses;
p.000471: (viii) facilitating and encouraging data exchange between the program and the prescription drug moni- toring
p.000471: programs of other States;
p.000471: (ix) enhancing data collection and quality, includ- ing improving patient matching and proactively moni- toring
p.000471: data quality;
p.000471: (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports
p.000471: for practitioners to review their prescribing patterns in comparison to such patterns of other
p.000471: practitioners in the specialty; and
p.000471: (xi) meeting the purpose of the program estab- lished under section 399O, as described in section
p.000471: 399O(a).
p.000471: (B) Promoting community or health system interven- tions.
p.000471: (C) Evaluating interventions to prevent controlled sub- stance overdoses.
p.000471: (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging
p.000471: public health crises and opportunities to address such cri- ses, such as enhancing public education and awareness on
p.000471: the risks associated with opioids.
p.000471: (3) ADDITIONAL GRANTS.—The Director may award grants to States, localities, and Indian Tribes—
p.000471: (A) to carry out innovative projects for grantees to rap- idly respond to controlled substance misuse, abuse,
p.000471: and overdoses, including changes in patterns of controlled sub- stance use; and
p.000471: (B) for any other evidence-based activity for pre- venting controlled substance misuse, abuse, and
p.000471: overdoses as the Director determines appropriate.
p.000471: (4) RESEARCH.—The Director, in coordination with the As- sistant Secretary for Mental Health and Substance Use
p.000471: and the National Mental Health and Substance Use Policy Labora- tory established under section 501A, as appropriate and
p.000471: appli- cable, may conduct studies and evaluations to address sub- stance use disorders, including
p.000471: preventing substance use dis-
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: January 30, 2020
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p.000471: orders or other related topics the Director determines appro- priate.
p.000471: (b) ENHANCED CONTROLLED SUBSTANCE OVERDOSE DATA COL-
p.000471: LECTION, ANALYSIS, AND DISSEMINATION GRANTS.—
p.000471: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000471: (A) to the extent practicable, carry out any controlled substance overdose data collection activities
p.000471: described in paragraph (2);
p.000471: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000471: out such activity;
p.000471: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and
p.000471: (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to sec- tion
p.000471: 505(d)(1)(A) (relating to the number of individuals ad- mitted to emergency departments as a result of the abuse of
p.000471: alcohol or other drugs).
p.000471: (2) CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION AND ANALYSIS ACTIVITIES.—A controlled substance
p.000471: overdose data collection, analysis, and dissemination activity described in this paragraph is any of the
p.000471: following activities:
p.000471: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal
p.000471: overdoses of controlled substances.
p.000471: (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on
p.000471: such overdoses from appropriate sources such as toxicology re- ports, autopsy reports, death scene
p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
p.000471: coroners, medical examiners, and public health laboratories to im- prove accurate testing and
p.000471: standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of
p.000471: various opioid analogues to con- trolled substance overdoses.
p.000471: (F) Working to enable and encourage the access, ex- change, and use of information regarding controlled
p.000471: sub- stance overdoses among data sources and entities.
p.000471: (c) DEFINITIONS.—In this section:
p.000471: (1) CONTROLLED SUBSTANCE.—The term ‘‘controlled sub- stance’’ has the meaning given that term in section 102 of
p.000471: the Controlled Substances Act.
p.000471: (2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the mean- ing given that term in section 4 of the Indian
p.000471: Self-Determina- tion and Education Assistance Act.
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: PUBLIC HEALTH SERVICE ACT
p.000473: Sec. 393A
p.000473:
p.000473: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, section 399O of this Act, and
p.000473: section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), there is authorized
p.000473: to be appropriated $496,000,000 for each of fiscal years 2019 through 2023.
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p.000473: January 30, 2020
p.000473: INTERPERSONAL VIOLENCE WITHIN FAMILIES AND AMONG ACQUAINTANCES
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p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
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p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: (2) the application contains the agreements and assur- ances required in this section, and the information
p.000491: required in subsection (j);
p.000491: (3) the application contains evidence that the preparation of the application has been coordinated with the
p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
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p.000493: January 30, 2020
p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
p.000493: reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106 of Public Law 106–310 (114
p.000493: Stat. 1175) attempts to make various amendments to section 399D, but the amendments cannot be executed because section
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p.000493: it would appear if the amendments described in section 3106 of the Public Law were executed to section 399A.
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: SEC. 399A. ø280d¿ GRANTS FOR SERVICES FOR CHILDREN OF SUB-
p.000493: STANCE ABUSERS. 94
p.000493: (a) ESTABLISHMENT.—
p.000493: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000493: Administra- tion, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000493: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000493: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000493: substance abuser; and
p.000493: (C) to identify such children and such families.
p.000493: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000493: and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted
p.000493: regarding the pro- mulgation of program guidelines and funding priorities under this section.
p.000493: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000493: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000493: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000493: Social Security Act for the State involved—
p.000493: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000493: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000493: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000493: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000493: such payments.
p.000493: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000493: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000493: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000493: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000493: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000493: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000493: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000493: garding the provision of services to the public.
p.000493: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000493: the appli- cant involved agrees to make available (directly or through agree- ments with other entities) to
p.000493: children of substance abusers each of the following services:
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: PUBLIC HEALTH SERVICE ACT
p.000495: Sec. 399A
p.000495:
p.000495: (1) Periodic evaluation of children for developmental, psy- chological, and medical problems.
p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
p.000495: (4) Therapeutic intervention services for children, includ- ing provision of therapeutic child care.
p.000495: (5) Preventive counseling services.
p.000495: (6) Counseling related to the witnessing of chronic vio- lence.
p.000495: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000495: (A) education and special education programs;
p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
p.000495: the State Interagency Coordinating Council, under part C of the Individuals with Disabilities Education Act.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: PUBLIC HEALTH SERVICE ACT
p.000497: Sec. 399A
p.000497:
p.000497: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000497: applicant involved agrees that the grant will not be expended—
p.000497: (1) to provide inpatient hospital services;
p.000497: (2) to make cash payments to intended recipients of serv- ices;
p.000497: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000497: build- ing or other facility, or purchase major medical equipment;
p.000497: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000497: of Federal funds; or
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p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
p.000497: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant involved
p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
p.000497: accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
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p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
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p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
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p.000501: health services, impose a charge or accept reimbursement available from any third- party payor, including
p.000501: reimbursement under any insurance policy or under any Federal or State health benefits pro- gram.
p.000501: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria
p.000501: for a waiver under such clause shall be made without regard to whether the organization accepts
p.000501: voluntary donations re- garding the provision of services to the public.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
p.000501: the family member involved:
p.000501: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000501: professional, or by a trained worker from the community who is supervised by a profes- sional, or by an
p.000501: entity, where the professional or entity provides assurances that the professional or entity is licensed or certified
p.000501: by the State if required and is complying with applicable licen- sure or certification requirements:
p.000501: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services
p.000501: and services for children of substance abusers.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
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p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
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p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
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p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
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p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
p.000507: Control, may make grants to States, or may make grants or enter into con- tracts with academic or
p.000507: nonprofit organizations designated by the State to operate the State’s cancer registry in lieu of mak- ing a grant
p.000507: directly to the State, to support the operation of population-based, statewide registries to collect, for each
p.000507: condi- tion specified in paragraph (2)(A), data concerning—
p.000507: (A) demographic information about each case of can-
p.000507:
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p.000507: cer;
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p.000535: PUBLIC HEALTH SERVICE ACT
p.000535: Sec. 399O
p.000535:
p.000535: (I) sharing of dispensing data in near-real time across State lines; and
p.000535: (II) integration of automated queries for multistate PDMP data and analytics into clinical workflow to
p.000535: improve the use of such data and ana- lytics by practitioners and dispensers; or
p.000535: (iv) improving the ability to include treatment availability resources and referral capabilities within the
p.000535: PDMP.
p.000535: (2) LEGISLATION.—As a condition on the receipt of support under this section, the Secretary shall require a State or
p.000535: local- ity to demonstrate that it has enacted legislation or regula- tions—
p.000535:
p.000535: and
p.000535: (A) to provide for the implementation of the PDMP;
p.000535: (B) to permit the imposition of appropriate penalties
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p.000535: for the unauthorized use and disclosure of information maintained by the PDMP.
p.000535: (b) PDMP STRATEGIES.—The Secretary shall encourage a State or locality, in establishing, improving, or
p.000535: maintaining a PDMP, to implement strategies that improve—
p.000535: (1) the reporting of dispensing in the State or locality of a controlled substance to an ultimate user so the
p.000535: reporting oc- curs not later than 24 hours after the dispensing event;
p.000535: (2) the consultation of the PDMP by each prescribing prac- titioner, or their designee, in the State or
p.000535: locality before initi- ating treatment with a controlled substance, or any substance as required by the State
p.000535: to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event;
p.000535: (3) the consultation of the PDMP before dispensing a con- trolled substance, or any substance as required by the State
p.000535: to be reported to the PDMP;
p.000535: (4) the proactive notification to a practitioner when pat- terns indicative of controlled substance misuse by a
p.000535: patient, in- cluding opioid misuse, are detected;
p.000535: (5) the availability of data in the PDMP to other States, as allowable under State law; and
p.000535: (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for
p.000535: surveillance, epidemiology, statistical research, or educational purposes.
p.000535: (c) DRUG MISUSE AND ABUSE.—In consultation with practi- tioners, dispensers, and other relevant and interested
p.000535: stakeholders, a State receiving support under this section—
p.000535: (1) shall establish a program to notify practitioners and dispensers of information that will help to identify
p.000535: and prevent the unlawful diversion or misuse of controlled substances;
p.000535: (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for
p.000535: carrying out drug diversion investigations if the State determines that informa- tion in the PDMP maintained
p.000535: by the State indicates an unlaw- ful diversion or abuse of a controlled substance;
p.000535: (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State
p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse,
p.000535: addiction, over- dose, and other aggregate information, as appropriate and in compliance with applicable
p.000535: Federal and State laws and pro- vided that such reports shall not include protected health in- formation;
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p.000537: PUBLIC HEALTH SERVICE ACT
p.000537: Sec. 399O
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p.000537: confidentiality requirement, including the regulations promul- gated under section 264(c) of the Health Insurance
p.000537: Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 543 of this Act.
p.000537: (4) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in this section shall be construed to create a
p.000537: Federal private cause of action.
p.000537: (i) PROGRESS REPORT.—Not later than 3 years after the date of enactment of this section, the Secretary shall—
p.000537: (1) complete a study that—
p.000537: (A) determines the progress of grantees in establishing and implementing PDMPs consistent with this section;
p.000537: (B) provides an analysis of the extent to which the op- eration of PDMPs has—
p.000537: (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances;
p.000537: (ii) established or strengthened initiatives to en- sure linkages to substance use disorder treatment
p.000537: services; or
p.000537: (iii) affected patient access to appropriate care in States operating PDMPs;
p.000537: (C) determine the progress of grantees in achieving interstate interoperability and intrastate
p.000537: interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress
p.000537: and recommendations for addressing these barriers;
p.000537: (D) determines the progress of grantees in imple- menting near real-time electronic PDMPs;
p.000537: (E) provides an analysis of the privacy protections in place for the information reported to the PDMP
p.000537: in each State or locality receiving support under this section and any recommendations of the Secretary
p.000537: for additional Fed- eral or State requirements for protection of this informa- tion;
p.000537: (F) determines the progress of States or localities in implementing technological alternatives to centralized
p.000537: data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such
p.000537: alternatives to enhance the privacy and security of individually identifi- able data; and
p.000537: (G) evaluates the penalties that States or localities have enacted for the unauthorized use and disclosure of
p.000537: in- formation maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify
p.000537: as appropriate for purposes of subsection (a)(2); and
p.000537: (2) submit a report to the Congress on the results of the study.
p.000537: (j) ADVISORY COUNCIL.—
p.000537: (1) ESTABLISHMENT.—A State or locality may establish an advisory council to assist in the establishment,
p.000537: improvement, or maintenance of a PDMP consistent with this section.
p.000537: (2) LIMITATION.—A State or locality may not use Federal funds for the operations of an advisory council to
p.000537: assist in the establishment, improvement, or maintenance of a PDMP.
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000537: Sec. 399O PUBLIC HEALTH SERVICE ACT 538
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p.000537: (3) SENSE OF CONGRESS.—It is the sense of the Congress that, in establishing an advisory council to assist in
p.000537: the estab- lishment, improvement, or maintenance of a PDMP, a State or locality should consult with appropriate
p.000537: professional boards and other interested parties.
p.000537: (k) DEFINITIONS.—For purposes of this section:
p.000537: (1) The term ‘‘controlled substance’’ means a controlled substance (as defined in section 102 of the
p.000537: Controlled Sub- stances Act) in schedule II, III, or IV of section 202 of such Act.
p.000537: (2) The term ‘‘dispense’’ means to deliver a controlled sub- stance to an ultimate user by, or pursuant to the lawful
p.000537: order of, a practitioner, irrespective of whether the dispenser uses the Internet or other means to effect such
p.000537: delivery.
p.000537: (3) The term ‘‘dispenser’’ means a physician, pharmacist, or other person that dispenses a controlled substance
p.000537: to an ul- timate user.
p.000537: (4) The term ‘‘interstate interoperability’’ with respect to a PDMP means the ability of the PDMP to
p.000537: electronically share reported information with another State if the information con- cerns either the dispensing of a
p.000537: controlled substance to an ulti- mate user who resides in such other State, or the dispensing of a
p.000537: controlled substance prescribed by a practitioner whose principal place of business is located in such other
p.000537: State.
p.000537: (5) The term ‘‘intrastate interoperability’’ with respect to a PDMP means the integration of PDMP data within
p.000537: electronic health records and health information technology infrastruc- ture or linking of a PDMP to other
p.000537: data systems within the State, including the State’s Medicaid program, workers’ com- pensation programs, and
p.000537: medical examiners or coroners.
p.000537: (6) The term ‘‘nonidentifiable information’’ means informa- tion that does not identify a practitioner, dispenser, or
p.000537: an ulti- mate user and with respect to which there is no reasonable basis to believe that the
p.000537: information can be used to identify a practitioner, dispenser, or an ultimate user.
p.000537: (7) The term ‘‘PDMP’’ means a prescription drug moni- toring program that is State-controlled.
p.000537: (8) The term ‘‘practitioner’’ means a physician, dentist, vet- erinarian, scientific investigator, pharmacy,
p.000537: hospital, or other person licensed, registered, or otherwise permitted, by the United States or the
p.000537: jurisdiction in which the individual prac- tices or does research, to distribute, dispense, conduct research with
p.000537: respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of
p.000537: professional practice or research.
p.000537: (9) The term ‘‘State’’ means each of the 50 States, the Dis- trict of Columbia, and any commonwealth or
p.000537: territory of the United States.
p.000537: (10) The term ‘‘ultimate user’’ means a person who has ob- tained from a dispenser, and who possesses, a
p.000537: controlled sub- stance for the person’s own use, for the use of a member of the person’s household, or for the
p.000537: use of an animal owned by the person or by a member of the person’s household.
p.000537: (11) The term ‘‘clinical workflow’’ means the integration of automated queries for prescription drug monitoring
p.000537: programs
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: PUBLIC HEALTH SERVICE ACT
p.000539: Sec. 399P
p.000539:
p.000539: data and analytics into health information technologies such as electronic health record systems, health information
p.000539: exchanges, and/or pharmacy dispensing software systems, thus stream- lining provider access through automated
p.000539: queries.
p.000539: SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYS- TEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING
p.000539: VIO- LENCE, SEXUAL ASSAULT, AND STALKING.
p.000539: (a) IN GENERAL.—The Secretary shall award grants for—
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p.000543: preterm, as appropriate.
p.000543: (b) ACTIVITIES.—Activities to be carried out under subsection
p.000543: (a) may include the establishment of—
p.000543: (1) programs, including those to test and evaluate strate- gies, which, in collaboration with States,
p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: ery;
p.000545: (A) the core risk factors for preterm labor and deliv-
p.000545: (B) evidence-based strategies to prevent preterm birth
p.000545: and associated outcomes;
p.000545: (C) medically indicated deliveries before full term, and the risks of non-medically indicated deliveries before
p.000545: full term;
p.000545: (D) the importance of preconception and prenatal care, including—
p.000545: (i) smoking cessation;
p.000545: (ii) weight maintenance and good nutrition, in- cluding folic acid intake;
p.000545: (iii) the screening for and the treatment of infec- tions;
p.000545: (iv) screening for and treatment of substance use disorders;
p.000545: (v) screening for and treatment of maternal de- pression;
p.000545: (vi) maternal immunization; and
p.000545: (vii) stress management;
p.000545: (E) treatments and outcomes for premature infants, including late preterm infants; and
p.000545: (F) the informational needs of families during the stay of an infant in a neonatal intensive care unit.
p.000545: (2) programs to increase the availability, awareness, and use of pregnancy and post-term information
p.000545: services that pro- vide evidence-based, clinical information through counselors, community outreach efforts,
p.000545: electronic or telephonic commu- nication, or other appropriate means regarding causes associ- ated with
p.000545: prematurity, birth defects, or health risks to a post- term infant, as well as prevention of a future preterm birth;
p.000545: (3) programs to respond to the informational needs of fami- lies during the stay of an infant in a neonatal
p.000545: intensive care unit, during the transition of the infant to the home, and in the event of a newborn death;
p.000545: and
p.000545: (4) such other programs as the Secretary determines ap- propriate to achieve the purpose specified in
p.000545: subsection (a).
p.000545: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000545: $1,900,000 for each of fiscal years 2014 through 2018.
p.000545: SEC. 399R. ø280g–6¿ CHRONIC KIDNEY DISEASE INITIATIVES.
p.000545: (a) IN GENERAL.—The Secretary shall establish pilot projects
p.000545:
p.000545:
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p.000555: nonprofit health and human services programs.
p.000555: (2) COMMUNITY SETTING.—The term ‘‘community setting’’ means a home or a community organization located in
p.000555: the neighborhood in which a participant in the program under this section resides.
p.000555: (3) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private entity (including a
p.000555: State or public subdivision of a State, a public health department, a free health clinic, a hospital, or
p.000555: a Federally-qualified health center (as defined in section 1861(aa) of the Social Security Act)), or a
p.000555: consortium of any such entities.
p.000555: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ means a community
p.000555: iden- tified by a State—
p.000555: (A) that has a substantial number of individuals who are members of a medically underserved population, as de-
p.000555: fined by section 330(b)(3); and
p.000555: (B) a significant portion of which is a health profes- sional shortage area as designated under section 332.
p.000555: SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
p.000555: (a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
p.000555: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Agency for Healthcare Research and Quality,
p.000555: shall establish a Primary Care Extension Program.
p.000555: (2) PURPOSE.—The Primary Care Extension Program shall provide support and assistance to primary care providers
p.000555: to educate providers about preventive medicine, health pro- motion, chronic disease management, mental
p.000555: and behavioral health services (including substance abuse prevention and treatment services), and
p.000555: evidence-based and evidence-informed therapies and techniques, in order to enable providers to incor- porate such
p.000555: matters into their practice and to improve commu- nity health by working with community-based health connec-
p.000555: tors (referred to in this section as ‘‘Health Extension Agents’’).
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000555:
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p.000557: PUBLIC HEALTH SERVICE ACT
p.000557: Sec. 399V–1
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p.000557: January 30, 2020
p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
...

p.000559: for the implementation of a Hub, for a period of 6 years; or
p.000559: (B) planning grants, that are awarded to State or multistate entities with the goal of developing a
p.000559: plan for a Hub, for a period of 2 years.
p.000559: (2) APPLICATIONS.—To be eligible for a grant under sub- section (b), a State or multistate entity shall submit
p.000559: to the Sec- retary an application, at such time, in such manner, and con- taining such information as the
p.000559: Secretary may require.
p.000559: (3) EVALUATION.—A State that receives a grant under sub- section (b) shall be evaluated at the end of the grant period
p.000559: by an evaluation panel appointed by the Secretary.
p.000559: (4) CONTINUING SUPPORT.—After the sixth year in which assistance is provided to a State under a grant awarded
p.000559: under subsection (b), the State may receive additional support under this section if the State program has received
p.000559: satisfactory eval- uations with respect to program performance and the merits of the State sustainability plan, as
p.000559: determined by the Secretary.
p.000559: (5) LIMITATION.—A State shall not use in excess of 10 per- cent of the amount received under a grant to carry out
p.000559: admin- istrative activities under this section. Funds awarded pursuant to this section shall not be used for funding
p.000559: direct patient care.
p.000559: (e) REQUIREMENTS ON THE SECRETARY.—In carrying out this section, the Secretary shall consult with the heads
p.000559: of other Federal agencies with demonstrated experience and expertise in health care and preventive medicine, such
p.000559: as the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Adminis- tration, the
p.000559: Health Resources and Services Administration, the Na- tional Institutes of Health, the Office of the National
p.000559: Coordinator for Health Information Technology, the Indian Health Service, the Agricultural Cooperative Extension
p.000559: Service of the Department of Agriculture, and other entities, as the Secretary determines appro- priate.
p.000559: (f) AUTHORIZATION OF APPROPRIATIONS.—To awards grants as provided in subsection (d), there are authorized to be
p.000559: appropriated
p.000559: $120,000,000 for each of fiscal years 2011 and 2012, and such sums as may be necessary to carry out this
p.000559: section for each of fiscal years 2013 through 2014.
p.000559: SEC. 399V–2. ø280g–13¿ NATIONAL CONGENITAL HEART DISEASE RE- SEARCH, SURVEILLANCE, AND AWARENESS.
p.000559: (a) IN GENERAL.—The Secretary shall, as appropriate—
p.000559: (1) enhance and expand research and data collection ef- forts related to congenital heart disease, including to
p.000559: study and track the epidemiology of congenital heart disease to under- stand health outcomes for
p.000559: individuals with congenital heart disease across all ages;
p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000559:
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p.000565: PUBLIC HEALTH SERVICE ACT
p.000565: Sec. 399V–4
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p.000565: January 30, 2020
p.000565: under subsection (a) and similar States not receiving such grants; and
p.000565: (E) a comparison, with regard to the measures de- scribed in paragraph (3), of—
p.000565: (i) States receiving grants under subsection (a);
p.000565: (ii) States that enacted, prior to the date of enact- ment of the Patient Protection and Affordable Care Act,
p.000565: any cap on non-economic damages; and
p.000565: (iii) States that have enacted, prior to the date of enactment of the Patient Protection and Affordable Care
p.000565: Act, a requirement that the complainant obtain an opinion regarding the merit of the claim, although the
p.000565: substance of such opinion may have no bearing on whether the complainant may proceed with a case.
p.000565: (3) MEASURES.—The evaluations under paragraph (2) shall analyze and make comparisons on the basis of—
p.000565: (A) the nature and number of disputes over injuries al- legedly caused by health care providers or health care
p.000565: or- ganizations;
p.000565: (B) the nature and number of claims in which tort liti- gation was pursued despite the existence of an alternative
p.000565: under subsection (a);
p.000565: (C) the disposition of disputes and claims, including the length of time and estimated costs to all parties;
p.000565: (D) the medical liability environment;
p.000565: (E) health care quality;
p.000565: (F) patient safety in terms of detecting, analyzing, and helping to reduce medical errors and adverse events;
p.000565: (G) patient and health care provider and organization satisfaction with the alternative under subsection (a) and
p.000565: with the medical liability environment; and
p.000565: (H) impact on utilization of medical services, appro- priately adjusted for risk.
p.000565: (4) FUNDING.—The Secretary shall reserve 5 percent of the amount appropriated in each fiscal year under
p.000565: subsection (k) to carry out this subsection.
p.000565: (h) MEDPAC AND MACPAC REPORTS.—
p.000565: (1) MEDPAC.—The Medicare Payment Advisory Commis- sion shall conduct an independent review of the alternatives to
p.000565: current tort litigation that are implemented under grants under subsection (a) to determine the
p.000565: impact of such alter- natives on the Medicare program under title XVIII of the So- cial Security Act, and
p.000565: its beneficiaries.
...

p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
p.000573: school personnel, such as administrators, teachers, nurses, counselors, and support personnel, as well
p.000573: as with other community providers co-located at the school;
p.000573: (v) the SBHC sponsoring facility assumes all re- sponsibility for the SBHC administration, operations, and
p.000573: oversight; and
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000573:
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
p.000573:
p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
p.000573: (A) Communities that have evidenced barriers to pri- mary health care and mental health and substance
p.000573: use disorder prevention services for children and adolescents.
p.000573: (B) Communities with high per capita numbers of chil- dren and adolescents who are uninsured, underinsured, or enrolled
p.000573: in public health insurance programs.
p.000573: (C) Populations of children and adolescents that have historically demonstrated difficulty in accessing health
p.000573: and mental health and substance use disorder prevention serv- ices.
p.000573: (2) The Secretary may give consideration to whether an applicant has received a grant under subsection
p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
p.000573: (2) upon a showing of good cause, waive the requirement that the SBHC provide all required comprehensive
p.000573: primary health services for a designated period of time to be deter- mined by the Secretary.
p.000573: (f) USE OF FUNDS.—
p.000573: (1) FUNDS.—Funds awarded under a grant under this sec- tion—
p.000573:
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p.000573: January 30, 2020
p.000573: (A) may be used for—
p.000573: (i) acquiring and leasing equipment (including the costs of amortizing the principle of, and paying inter- est
p.000573: on, loans for such equipment);
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p.000745:
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p.000745: (B) associated with an accredited medical or research training institution;
p.000745: (7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health
p.000745: Service, persons not otherwise eligible for such treatment;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000747: PUBLIC HEALTH SERVICE ACT
p.000747: Sec. 464J
p.000747:
p.000747: (8) provide to health officials, scientists, and appropriate public and other nonprofit institutions and
p.000747: organizations, tech- nical advice and assistance on the application of statistical and other scientific research
p.000747: methods to experiments, studies, and surveys in health and medical fields;
p.000747: (9) enter into contracts under this title without regard to sections 3648 and 3709 of the Revised
p.000747: Statutes (31 U.S.C. 529; 39 41 U.S.C. 5); and
p.000747: (10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and Alcoholism, such
p.000747: additional means as he deems necessary or appropriate to carry out the purposes of this section.
p.000747: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000747: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000747: Institute and in disseminating the results of such research to health professionals and the general public.
p.000747: ASSOCIATE DIRECTOR FOR PREVENTION
p.000747: SEC. 464I. ø285n–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000747: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000747: concerning the prevention of alcohol abuse and al- coholism. The Associate Director shall be appointed by the Director
p.000747: of the Institute from individuals who because of their professional training or expertise are experts in
p.000747: alcohol abuse and alcoholism or the prevention of such.
p.000747: (b) BIENNIAL REPORT.—The Associate Director for Prevention shall prepare for inclusion in the biennial
p.000747: report made under sec- tion 407 a description of the prevention activities of the Institute, including a
p.000747: description of the staff and resources allocated to those activities.
p.000747: NATIONAL ALCOHOL RESEARCH CENTER
p.000747: SEC. 464J. ø285n–2¿ (a) The Secretary acting through the In- stitute may designate National Alcohol
p.000747: Research Centers for the purpose of interdisciplinary research relating to alcoholism and other biomedical,
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p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
p.000747:
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p.000747: January 30, 2020
p.000747: 40 So in law. See section 16(a)(5) of Public Law 96–180 (93 Stat. 1305). The period probably should be
p.000747: ‘‘; and’’. (Section 464J formerly was section 504 of another law. The amendment made by Public Law 96–180 was directed
p.000747: to section 504 of that other law, which was Public Law 91– 616.)
p.000747: 41 So in law. See section 2(a) of Public Law 102–352 (106 Stat. 938). Section 701(1) does not provide
p.000747: a definition for the term ‘‘construction’’, but former section 701(1) did provide such a definition.
p.000747: Public Law 102–408 amended title VII generally; definitions for the title are now pro- vided in section 799, and that
p.000747: section does not define the term ‘‘construction’’.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000749: PUBLIC HEALTH SERVICE ACT
p.000749: Sec. 464N
p.000749:
p.000749: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Substance Abuse and Mental Health
p.000749: Services Ad- ministration in focusing the services research activities of the Insti- tute and in disseminating the
p.000749: results of such research to health professionals and the general public.
p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
p.000749: SEC. 464M. ø285o–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000749: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000749: concerning the prevention of drug abuse. The Asso- ciate Director shall be appointed by the Director of the
p.000749: Institute from individuals who because of their professional training or ex- pertise are experts in drug abuse
p.000749: and the prevention of such abuse.
p.000749: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000749: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000749: and resources allocated to those activities.
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p.000751: Subpart 16—National Institute of Mental Health
p.000751:
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p.000751: January 30, 2020
p.000751:
p.000751: PURPOSE OF INSTITUTE
p.000751: SEC. 464R. ø285p¿ (a) IN GENERAL.—The general purpose of the National Institute of Mental Health
p.000751: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of bio- medical
p.000751: and behavioral research, health services research, research training, and health information dissemination with respect
p.000751: to the cause, diagnosis, treatment, control and prevention of mental ill- ness.
p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
...

p.000759: ‘‘CENTER’’ appears in small caps.
p.000759: 47 The word ‘‘CENTER’’ in the section heading for section 464z–3 probably should read ‘‘IN- STITUTE’’. See
p.000759: amendment made by section 10334(c)(1)(D)(iii) of Public Law 111–148.
p.000759: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000759: Sec. 464z–3 PUBLIC HEALTH SERVICE ACT 760
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p.000759: (b) PRIORITIES.—The Director of the Institute shall in expend- ing amounts appropriated under this subpart
p.000759: give priority to con- ducting and supporting minority health disparities research.
p.000759: (c) MINORITY HEALTH DISPARITIES RESEARCH.—For purposes of this subpart:
p.000759: (1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral research on minority health
p.000759: con- ditions (as defined in paragraph (2)), including research to pre- vent, diagnose, and treat such conditions.
p.000759: (2) The term ‘‘minority health conditions’’, with respect to individuals who are members of minority
p.000759: groups, means all diseases, disorders, and conditions (including with respect to mental health and substance
p.000759: abuse)—
p.000759: (A) unique to, more serious, or more prevalent in such individuals;
p.000759: (B) for which the factors of medical risk or types of medical intervention may be different for such
p.000759: individuals, or for which it is unknown whether such factors or types are different for such individuals; or
p.000759: (C) with respect to which there has been insufficient research involving such individuals as subjects or
p.000759: insuffi- cient data on such individuals.
p.000759: (3) The term ‘‘minority group’’ has the meaning given the term ‘‘racial and ethnic minority group’’ in section
p.000759: 1707.
p.000759: (4) The terms ‘‘minority’’ and ‘‘minorities’’ refer to individ- uals from a minority group.
p.000759: (d) HEALTH DISPARITY POPULATIONS.—For purposes of this subpart:
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p.000759: (1) A population is a health disparity population if, as de- termined by the Director of the Institute after
p.000759: consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant
p.000759: disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the
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p.000823: Health, as the Director of the National Institutes of Health determines is appropriate.
p.000823: (2) SUPPORT SERVICES.—The Director of the National Insti- tutes of Health may provide facilities, utilities and
p.000823: support services to the Foundation if it is determined by the Director to be advantageous to the
p.000823: research programs of the National Institutes of Health.
p.000823: (l) FUNDING.—From amounts appropriated to the National In- stitutes of Health, for each fiscal year, the
p.000823: Director of NIH shall transfer not less than $500,000 and not more than $1,250,000 to the Foundation.
p.000823: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000825: PUBLIC HEALTH SERVICE ACT
p.000825: Sec. 501
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p.000825: January 30, 2020
p.000825: TITLE V—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
p.000825: PART A—ORGANIZATION AND GENERAL AUTHORITIES
p.000825: SEC. 501. ø290aa¿ SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
p.000825: (a) ESTABLISHMENT.—The Substance Abuse and Mental Health Services Administration (hereafter referred to in this
p.000825: title as the ‘‘Administration’’) is an agency of the Service.
p.000825: (b) CENTERS.—The following Centers are agencies of the Ad- ministration:
p.000825: (1) The Center for Substance Abuse Treatment.
p.000825: (2) The Center for Substance Abuse Prevention.
p.000825: (3) The Center for Mental Health Services.
p.000825: (c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SEC-
p.000825: RETARY.—
p.000825: (1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant
p.000825: Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘‘Assistant
p.000825: Secretary’’) who shall be ap- pointed by the President, by and with the advice and consent of the Senate.
p.000825: (2) DEPUTY ASSISTANT SECRETARY.—The Assistant Sec- retary, with the approval of the Secretary, may appoint
p.000825: a Dep- uty Assistant Secretary and may employ and prescribe the functions of such officers and employees,
p.000825: including attorneys, as are necessary to administer the activities to be carried out through the
p.000825: Administration.
p.000825: (d) AUTHORITIES.—The Secretary, acting through the Assistant Secretary, shall—
p.000825: (1) supervise the functions of the Centers of the Adminis- tration in order to assure that the
p.000825: programs carried out through each such Center receive appropriate and equitable support and that there is
p.000825: cooperation among the Centers in the implementation of such programs;
p.000825: (2) establish and implement, through the respective Cen- ters, a comprehensive program to improve the
p.000825: provision of treatment and related services to individuals with respect to substance use disorders and mental
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p.000825: knowledge dissemination, and public information functions that are re- quired for the implementation of this
p.000825: title;
p.000825: (4) assure that the Administration conduct and coordinate demonstration projects, evaluations, and service system
p.000825: assess- ments and other activities necessary to improve the avail- ability and quality of treatment,
p.000825: prevention and related serv- ices;
p.000825: (5) support activities that will improve the provision of treatment, prevention and related services, including
p.000825: the devel-
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p.000825: opment of national mental health and substance use disorder goals and model programs;
p.000825: (6) in cooperation with the National Institutes of Health, the Centers for Disease Control and
p.000825: Prevention, and the Health Resources and Services Administration, develop edu- cational materials and
p.000825: intervention strategies to reduce the risks of HIV, hepatitis, tuberculosis, and other communicable diseases
p.000825: among individuals with mental or substance use dis- orders, and to develop appropriate mental health
p.000825: services for individuals with such diseases or disorders;
p.000825: (7) coordinate Federal policy with respect to the provision of treatment services for substance use
p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
p.000825: delivery and effectiveness of prevention, treat- ment, and recovery support services and are appropriately
p.000825: in- corporated into programs carried out by the Administration;
p.000825: (10) encourage public and private entities that provide health insurance to provide benefits for substance use
p.000825: disorder and mental health services;
p.000825: (11) work with relevant agencies of the Department of Health and Human Services on integrating mental health
p.000825: pro- motion and substance use disorder prevention with general health promotion and disease prevention and
p.000825: integrating men- tal and substance use disorders treatment services with phys- ical health treatment services;
p.000825: (12) monitor compliance by hospitals and other facilities with the requirements of sections 542 and 543;
p.000825: (13) with respect to grant programs authorized under this title or part B of title XIX, or grant programs otherwise
p.000825: funded by the Administration—
p.000825: (A) require that all grants that are awarded for the provision of services are subject to performance
p.000825: and out- come evaluations;
p.000825: (B) ensure that the director of each Center of the Ad- ministration consistently documents the application of cri-
p.000825: teria when awarding grants and the ongoing oversight of grantees after such grants are awarded;
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: PUBLIC HEALTH SERVICE ACT
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p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
p.000827: evaluating service pro- grams for the prevention and treatment of alcoholism and alco- hol abuse within the
p.000827: Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center for Mental Health
p.000827: Services, and coordinating such programs among the Centers, and among the Centers and other public
p.000827: and private entities. The Associate Administrator also may en- sure that alcohol prevention, education, and
p.000827: policy strategies are integrated into all programs of the Centers that address substance abuse prevention,
p.000827: education, and policy, and that the Center for Substance Abuse Prevention addresses the Healthy
p.000827: People 2010 goals and the National Dietary Guide-
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: lines of the Department of Health and Human Services and the Department of Agriculture related to alcohol
p.000829: consumption.
p.000829: (2) PLAN.—
p.000829: (A) The Assistant Secretary, acting through the Asso- ciate Administrator for Alcohol Prevention and
p.000829: Treatment Policy, shall develop, and periodically review and as appro- priate revise, a plan for programs and policies
p.000829: to treat and prevent alcoholism and alcohol abuse. The plan shall be developed (and reviewed and revised) in
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p.000829: pre- vention and treatment programs undertaken by the Ad- ministration and its agencies, and the report shall
p.000829: include a detailed statement of the expenditures made for the ac- tivities reported on and the personnel
p.000829: used in connection with such activities.
p.000829: (B) Each report under subparagraph (A) shall include a description of any revisions in the plan under paragraph
p.000829: (2) made during the preceding 2 years.
p.000829: (C) Each report under subparagraph (A) shall be sub- mitted to the Assistant Secretary for inclusion in the bien- nial
p.000829: report under subsection (m).
p.000829: (f) ASSOCIATE ADMINISTRATOR FOR WOMEN’S SERVICES.—
p.000829: (1) APPOINTMENT.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint an Associate
p.000829: Adminis- trator for Women’s Services who shall report directly to the As- sistant Secretary.
p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
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p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
p.000829: ferred to in paragraph (3)), and report biannually to the Assistant Secretary regarding the extent to which
p.000829: women are represented among senior personnel, and make recommendations regarding improvement in the participation
p.000829: of women in the workforce of the Admin- istration; and
p.000829: (iii) prepare, for inclusion in the biennial report required pursuant to subsection (m), a description of
p.000829: activities of the Committee, including findings made by the Committee regarding—
p.000829: (I) the extent of expenditures made for wom- en’s substance abuse and mental health services by the
p.000829: agencies of the Administration; and
p.000829: (II) the estimated level of funding needed for substance abuse and mental health services to meet the
p.000829: needs of women;
p.000829: (D) improve the collection of data on women’s health by—
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p.000829: (i) reviewing the current data at the Administra- tion to determine its uniformity and applicability;
p.000829: (ii) developing standards for all programs funded by the Administration so that data are, to the extent
p.000829: practicable, collected and reported using common re- porting formats, linkages and definitions; and
p.000829: (iii) reporting to the Assistant Secretary a plan for incorporating the standards developed under clause
p.000829: (ii) in all Administration programs and a plan to as- sure that the data so collected are accessible to health
p.000829: professionals, providers, researchers, and members of the public; and
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: 831
p.000831: PUBLIC HEALTH SERVICE ACT
p.000831: Sec. 501
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p.000831: January 30, 2020
p.000831: (E) shall establish, maintain, and operate a program to provide information on women’s substance abuse
p.000831: and mental health services.
p.000831: (3) STUDY.—
p.000831: (A) The Secretary, acting through the Assistant Sec- retary for Personnel, shall conduct a study to evaluate the
p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: Sec. 501 PUBLIC HEALTH SERVICE ACT 832
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p.000831: (B) assist the Assistant Secretary in the evaluation, organization, integration, and coordination of programs
p.000831: op- erated by the Administration;
p.000831: (C) promote evidence-based and promising best prac- tices, including culturally and linguistically
p.000831: appropriate practices, as appropriate, for the prevention and treatment of, and recovery from, mental and substance use
p.000831: disorders, including serious mental illness and serious emotional dis- turbances;
...

p.000833: Reform Act of 2016 and the report of the Inter- departmental Serious Mental Illness Coordinating
p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000833: January 30, 2020
p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000833: priate, for individuals with a mental or substance use dis- order;
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p.000833: peer support specialists, licensed professional counselors, or other licensed or certified mental health or
p.000833: substance use disorder professionals, including such profes- sionals specializing in the diagnosis,
p.000833: evaluation, or treatment of adults with a serious mental illness or children with a serious emotional
p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
p.000833: adults with a se- rious mental illness and children with a serious emotional disturbance, and for individuals with
p.000833: a substance use dis- order.
p.000833: (m) BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.—Not later than September 30, 2020,
p.000833: and every 2 years thereafter, the Assistant Secretary shall prepare and submit to the Committee on Energy and Commerce
p.000833: and the Committee on Appro- priations of the House of Representatives and the Committee on Health, Education,
p.000833: Labor, and Pensions and the Committee on Ap- propriations of the Senate, and post on the Internet website of the
p.000833: Administration, a report containing at a minimum—
p.000833: (1) a review of activities conducted or supported by the Ad- ministration, including progress toward strategic
p.000833: priorities, goals, and objectives identified in the strategic plan developed under subsection (l);
p.000833: (2) an assessment of programs and activities carried out by the Assistant Secretary, including the extent to
p.000833: which pro- grams and activities under this title and part B of title XIX meet identified goals and
p.000833: performance measures developed for the respective programs and activities;
p.000833: (3) a description of the progress made in addressing gaps in mental and substance use disorders
p.000833: prevention, treatment, and recovery services and improving outcomes by the Adminis-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: 835
p.000835: PUBLIC HEALTH SERVICE ACT
p.000835: Sec. 501
p.000835:
p.000835: tration, including with respect to serious mental illnesses, seri- ous emotional disturbances, and co-occurring
p.000835: disorders;
p.000835: (4) a description of the manner in which the Administra- tion coordinates and partners with other Federal
p.000835: agencies and departments related to mental and substance use disorders, in- cluding activities related to—
p.000835: (A) the implementation and dissemination of research findings into improved programs, including with respect to
p.000835: how advances in serious mental illness and serious emo- tional disturbance research have been incorporated
p.000835: into programs;
p.000835: (B) the recruitment, training, and retention of a men- tal and substance use disorders workforce;
p.000835: (C) the integration of mental disorder services, sub- stance use disorder services, and physical health
p.000835: services;
p.000835: (D) homelessness; and
p.000835: (E) veterans;
p.000835: (5) a description of the manner in which the Administra- tion promotes coordination by grantees under
p.000835: this title, and part B of title XIX, with State or local agencies; and
p.000835: (6) a description of the activities carried out under section 501A(e), with respect to mental and substance use
p.000835: disorders, including—
p.000835: (A) the number and a description of grants awarded;
p.000835: (B) the total amount of funding for grants awarded;
p.000835: (C) a description of the activities supported through such grants, including outcomes of programs
p.000835: supported; and
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p.000835: (D) information on how the National Mental Health and Substance Use Policy Laboratory is consulting with
p.000835: the Assistant Secretary for Planning and Evaluation and collaborating with the Center for Substance Abuse
p.000835: Treat- ment, the Center for Substance Abuse Prevention, the Center for Behavioral Health Statistics and
p.000835: Quality, and the Center for Mental Health Services to carry out such activities; and
p.000835: (7) recommendations made by the Assistant Secretary for Planning and Evaluation under section 6021 of the
p.000835: Helping Families in Mental Health Crisis Reform Act of 2016 to im- prove programs within the
p.000835: Administration, and actions taken in response to such recommendations to improve programs within the
p.000835: Administration.
p.000835: The Assistant Secretary may meet reporting requirements estab- lished under this title by providing the contents
p.000835: of such reports as an addendum to the biennial report established under this sub- section, notwithstanding
p.000835: the timeline of other reporting require- ments in this title. Nothing in this subsection shall be
p.000835: construed to alter the content requirements of such reports or authorize the Assistant Secretary to alter
p.000835: the timeline of any such reports to be less frequent than biennially, unless as specified in this title.
p.000835: (n) APPLICATIONS FOR GRANTS AND CONTRACTS.—With respect to awards of grants, cooperative agreements, and
p.000835: contracts under this title, the Assistant Secretary, or the Director of the Center in- volved, as the case may be, may
p.000835: not make such an award unless—
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: Sec. 501A PUBLIC HEALTH SERVICE ACT 836
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p.000835: (1) an application for the award is submitted to the official involved;
p.000835: (2) with respect to carrying out the purpose for which the award is to be provided, the application provides
p.000835: assurances of compliance satisfactory to such official; and
p.000835: (3) the application is otherwise in such form, is made in such manner, and contains such agreements,
p.000835: assurances, and information as the official determines to be necessary to carry out the purpose for which the award is
p.000835: to be provided.
p.000835: (o) EMERGENCY RESPONSE.—
p.000835: (1) IN GENERAL.—Notwithstanding section 504 and except as provided in paragraph (2), the Secretary may use not to
p.000835: ex- ceed 2.5 percent of all amounts appropriated under this title for a fiscal year to make
p.000835: noncompetitive grants, contracts or cooperative agreements to public entities to enable such enti- ties to
p.000835: address emergency substance abuse or mental health needs in local communities.
p.000835: (2) EXCEPTIONS.—Amounts appropriated under part C shall not be subject to paragraph (1).
p.000835: (3) EMERGENCIES.—The Secretary shall establish criteria for determining that a substance abuse or mental health
p.000835: emer- gency exists and publish such criteria in the Federal Register prior to providing funds under this
p.000835: subsection.
p.000835: (4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the
p.000835: end of the fiscal year following the fiscal year for which such amounts are appropriated.
p.000835: (p) LIMITATION ON THE USE OF CERTAIN INFORMATION.—No in- formation, if an establishment or person supplying the
p.000835: information or described in it is identifiable, obtained in the course of activities undertaken or supported under
p.000835: section 505 may be used for any purpose other than the purpose for which it was supplied unless such
p.000835: establishment or person has consented (as determined under regulations of the Secretary) to its use for such
p.000835: other purpose. Such information may not be published or released in other form if the person who supplied
p.000835: the information or who is described in it is identifiable unless such person has consented (as determined under
p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
p.000835: SEC. 501A. ø290aa–0¿ NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
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p.000835: Crisis Reform Act of 2016;
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: PUBLIC HEALTH SERVICE ACT
p.000837: Sec. 501A
p.000837:
p.000837: (2) identify, coordinate, and facilitate the implementation of policy changes likely to have a significant
p.000837: effect on mental health, mental illness, recovery supports, and the prevention and treatment of substance use
p.000837: disorder services;
p.000837: (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information
p.000837: from grant- ees under programs operated by the Administration in order to evaluate and disseminate information on
p.000837: evidence-based prac- tices, including culturally and linguistically appropriate serv- ices, as appropriate, and
p.000837: service delivery models;
p.000837: (4) provide leadership in identifying and coordinating poli- cies and programs, including evidence-based programs,
p.000837: related to mental and substance use disorders;
p.000837: (5) periodically review programs and activities operated by the Administration relating to the diagnosis or
p.000837: prevention of, treatment for, and recovery from, mental and substance use disorders to—
p.000837: (A) identify any such programs or activities that are duplicative;
p.000837: (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
p.000837: (C) formulate recommendations for coordinating, elimi- nating, or improving programs or activities
p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
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p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
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p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
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p.000837: January 30, 2020
p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000839: 839
p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
p.000839: (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.
p.000839: ADVISORY COUNCILS
p.000839: SEC. 502. ø290aa–1¿ (a) APPOINTMENT.—
p.000839: (1) IN GENERAL.—The Secretary shall appoint an advisory council for—
p.000839: (A) the Substance Abuse and Mental Health Services Administration;
p.000839: (B) the Center for Substance Abuse Treatment;
p.000839: (C) the Center for Substance Abuse Prevention; and
p.000839: (D) the Center for Mental Health Services.
p.000839: Each such advisory council shall advise, consult with, and make recommendations to the Secretary and the
p.000839: Assistant Sec- retary or Director of the Administration or Center for which the advisory council is
p.000839: established concerning matters relating to the activities carried out by and through the Administration or Center and
p.000839: the policies respecting such activities.
p.000839: (2) FUNCTION AND ACTIVITIES.—An advisory council—
p.000839: (A)(i) may on the basis of the materials provided by the organization respecting activities conducted at
p.000839: the or- ganization, make recommendations to the Assistant Sec- retary or Director of the Administration or
p.000839: Center for which it was established respecting such activities;
p.000839: (ii) shall review applications submitted for grants and cooperative agreements for activities for which advisory
p.000839: council approval is required under section 504(d)(2) and recommend for approval applications for projects that
p.000839: show promise of making valuable contributions to the Adminis- tration’s mission; and
p.000839: (iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the or-
p.000839: ganization;
p.000839: (B) may collect, by correspondence or by personal in- vestigation, information as to studies and services that
p.000839: are being carried on in the United States or any other country as to the diseases, disorders, or other aspects
p.000839: of human health with respect to which the organization was estab- lished and with the approval of the
...

p.000839: physician assistant; and
p.000839: (ii) shall specialize in the mental health field.
p.000839: (D) Not less than half of the members of the advisory councils appointed under subsections (a)(1)(B) and
p.000839: (a)(1)(C)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree; or
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000839:
p.000839:
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p.000839:
p.000841: 841
p.000841: PUBLIC HEALTH SERVICE ACT
p.000841: Sec. 502
p.000841:
p.000841:
p.000841:
p.000841:
p.000841:
p.000841:
p.000841:
p.000841:
p.000841:
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p.000841:
p.000841:
p.000841:
p.000841: January 30, 2020
p.000841: (III) have an advanced degree in nursing, public health, behavioral or social sciences, or so- cial
p.000841: work from an accredited graduate school or be a certified physician assistant; and
p.000841: (ii) shall have experience in the provision of sub- stance use disorder services or the development and
p.000841: implementation of programs to prevent substance mis- use.
p.000841: (4) COMPENSATION.—Members of an advisory council who are officers or employees of the United States shall not
p.000841: receive any compensation for service on the advisory council. The re- maining members of an advisory council
p.000841: shall receive, for each day (including travel time) they are engaged in the perform- ance of the functions
p.000841: of the advisory council, compensation at rates not to exceed the daily equivalent to the annual rate in
p.000841: effect for grade GS–18 of the General Schedule.
p.000841: (c) TERMS OF OFFICE.—
p.000841: (1) IN GENERAL.—The term of office of a member of an ad- visory council appointed under subsection (b) shall be 4
p.000841: years, except that any member appointed to fill a vacancy for an un- expired term shall serve for the remainder
p.000841: of such term. The Secretary shall make appointments to an advisory council in such a manner as to ensure
p.000841: that the terms of the members not all expire in the same year. A member of an advisory council may serve
p.000841: after the expiration of such member’s term until a successor has been appointed and taken office.
p.000841: (2) REAPPOINTMENTS.—A member who has been appointed to an advisory council for a term of 4 years may not
p.000841: be re- appointed to an advisory council during the 2-year period be- ginning on the date on which such 4-year
p.000841: term expired.
p.000841: (3) TIME FOR APPOINTMENT.—If a vacancy occurs in an ad- visory council among the members under subsection (b),
p.000841: the Secretary shall make an appointment to fill such vacancy with- in 90 days from the date the vacancy occurs.
...

p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
p.000841: (1) a summary of the manner in which individuals with co- occurring disorders are receiving treatment, including the
p.000841: most up-to-date information available regarding the number of chil- dren and adults with co-occurring mental illness
p.000841: and substance abuse disorders and the manner in which funds provided under sections 1911 and 1921 are
p.000841: being utilized, including the number of such children and adults served with such funds;
p.000841: (2) a summary of improvements necessary to ensure that individuals with co-occurring mental illness
p.000841: and substance abuse disorders receive the services they need;
p.000841: (3) a summary of practices for preventing substance abuse among individuals who have a mental illness and are
p.000841: at risk of having or acquiring a substance abuse disorder; and
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000841:
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p.000841:
p.000843: 843
p.000843: PUBLIC HEALTH SERVICE ACT
p.000843: Sec. 505
p.000843:
p.000843: (4) a summary of evidenced-based practices for treating in- dividuals with co-occurring mental illness and substance
p.000843: abuse disorders and recommendations for implementing such prac- tices.
p.000843: (c) FUNDS FOR REPORT.—The Secretary may obligate funds to carry out this section with such appropriations as
p.000843: are available.
p.000843: SEC. 504. 1 ø290aa–3¿ PEER REVIEW.
p.000843: (a) IN GENERAL.—The Secretary, after consultation with the Assistant Secretary, shall require
p.000843: appropriate peer review of grants, cooperative agreements, and contracts to be administered through the
p.000843: agency which exceed the simple acquisition threshold as defined in section 4(11) of the Office of Federal
p.000843: Procurement Pol- icy Act.
p.000843: (b) MEMBERS.—The members of any peer review group estab- lished under subsection (a) shall be individuals
p.000843: who by virtue of their training or experience are eminently qualified to perform the review functions of the
p.000843: group. Not more than one-fourth of the members of any such peer review group shall be officers or employ- ees of
p.000843: the United States. In the case of any such peer review group that is reviewing a grant, cooperative agreement,
p.000843: or contract re- lated to mental illness treatment, not less than half of the mem- bers of such peer
p.000843: review group shall be licensed and experienced professionals in the prevention, diagnosis, or treatment of, or
p.000843: recov- ery from, mental illness or co-occurring mental illness and sub- stance use disorders and have a
p.000843: medical degree, a doctoral degree in psychology, or an advanced degree in nursing or social work from an
...

p.000843: Health Statistics
p.000843:
p.000843: 1 Section 504 appears according to the probable intent of the Congress. Section 3401(b) of Pub- lic Law 106–310 (114
p.000843: Stat. 1218) provides that the section ‘‘is amended as follows:’’. No amend- atory instructions were then given, but a
p.000843: substitute text was provided. The amendment probably should have instructed that section 504 ‘‘is amended to read as
p.000843: follows:’’.
p.000843: 2 Section 502 of Public Law 104–237 (110 Stat. 3112) provides as follows:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: Continued
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
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p.000843: Sec. 505 PUBLIC HEALTH SERVICE ACT 844
p.000843:
p.000843: and Quality (in this section referred to as the ‘‘Center’’). The Cen- ter shall be headed by a Director (in
p.000843: this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive
p.000843: experience and academic qualifications in research and analysis in behavioral health care or related fields. (b)
p.000843: The Director shall—
p.000843: (1) coordinate the Administration’s integrated data strategy, including by collecting data each year on——
p.000843: (A) the national incidence and prevalence of the var- ious forms of mental illness and substance abuse; and
p.000843: (B) the incidence and prevalence of such various forms in major metropolitan areas selected by the Director. 3
p.000843: (2) provide statistical and analytical support for activities of the Administration;
p.000843: (3) recommend a core set of performance metrics to evalu- ate activities supported by the Administration; and
p.000843: (4) coordinate with the Assistant Secretary, the Assistant Secretary for Planning and Evaluation, and the
p.000843: Chief Medical Officer appointed under section 501(g), as appropriate, to im- prove the quality of services
p.000843: provided by programs of the Ad- ministration and the evaluation of activities carried out by the Administration.
p.000843: (c) MENTAL HEALTH.—With respect to the activities of the Di- rector under subsection (b)(1) relating to mental
p.000843: health, the Direc- tor shall ensure that such activities include, at a minimum, the col- lection of data on—
p.000843: (1) the number and variety of public and nonprofit private treatment programs;
p.000843: (2) the number and demographic characteristics of individ- uals receiving treatment through such programs;
p.000843: (3) the type of care received by such individuals; and
p.000843: (4) such other data as may be appropriate.
p.000843: (d) SUBSTANCE ABUSE.—
p.000843: (1) IN GENERAL.—With respect to the activities of the Di- rector under subsection (b)(1) relating to
p.000843: substance abuse, the Director shall ensure that such activities include, at a min- imum, the collection of
p.000843: data on—
p.000843: (A) the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of
p.000843: alcohol or other drugs;
p.000843: (B) the number of deaths occurring as a result of substance abuse, as indicated in reports by coroners in coordination
p.000843: with the Centers for Disease Control and Prevention;
p.000843: (C) the number and variety of public and private nonprofit treatment programs, including the number and type of patient
p.000843: slots available;
p.000843: (D) the number of individuals seeking treatment through such programs, the number and demographic
p.000843: characteristics of individuals receiving such treatment, the percentage of individ-
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: ‘‘The Secretary of Health and Human Services shall develop a public health monitoring pro- gram to monitor
p.000843: methamphetamine abuse in the United States. The program shall include the collection and dissemination of data
p.000843: related to methamphetamine abuse which can be used by public health officials in policy development.’’.
p.000843: 3 So in law. The period at the end of subparagraph (B) probably should be a semicolon.
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000845: 845
p.000845: PUBLIC HEALTH SERVICE ACT
p.000845: Sec. 506
p.000845:
p.000845: uals who complete such programs, and, with respect to individ- uals receiving such treatment, the length of time
p.000845: between an individual’s request for treatment and the commencement of treatment;
p.000845: (E) the number of such individuals who return for treat- ment after the completion of a prior treatment
p.000845: in such pro- grams and the method of treatment utilized during the prior treatment;
p.000845: (F) the number of individuals receiving public assistance for such treatment programs;
p.000845: (G) the costs of the different types of treatment modalities for drug and alcohol abuse and the aggregate
p.000845: relative costs of each such treatment modality provided within a State in each fiscal year;
p.000845: (H) to the extent of available information, the number of individuals receiving treatment for alcohol or
p.000845: drug abuse who have private insurance coverage for the costs of such treat- ment;
p.000845: (I) the extent of alcohol and drug abuse among high school students and among the general population; and
p.000845: (J) the number of alcohol and drug abuse counselors and other substance abuse treatment personnel employed in
p.000845: public and private treatment facilities.
p.000845: (2) ANNUAL SURVEYS; PUBLIC AVAILABILITY OF DATA.—Annual survey 4s shall be carried out in the
p.000845: collection of data under this subsection. Summaries and analyses of the data collected shall be made
p.000845: available to the public.
p.000845: (e) CONSULTATION.—After consultation with the States and with appropriate national organizations, the
p.000845: Assistant Secretary shall use existing standards and best practices to develop uniform criteria for the
p.000845: collection of data, using the best available tech- nology, pursuant to this section.
p.000845: SEC. 506. ø290aa–5¿ GRANTS FOR THE BENEFIT OF HOMELESS INDIVID- UALS.
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts and cooperative agreements to community-based public
p.000845: and private nonprofit entities for the purposes of providing mental health and substance use disorder
p.000845: services for homeless individuals. In car- rying out this section, the Secretary shall consult with the
p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
p.000845: (b) PREFERENCES.—In awarding grants, contracts, and coopera- tive agreements under subsection (a), the Secretary
p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
p.000845: homeless in- dividuals;
p.000845: (2) entities that demonstrate effectiveness in serving run- away, homeless, and street youth;
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 4 The heading for paragraph (2) is the result of the amendment made by section 6004(6)(C) of Public Law
p.000845: 114–255. Such amendment probably should not have been made to strike ‘‘AN- NUAL SURVEYS’’ (initial cap and
p.000845: small caps) and instead should have been ‘‘Annual Surveys’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000845:
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p.000845: Sec. 506A PUBLIC HEALTH SERVICE ACT 846
p.000845:
p.000845: (3) entities that have experience in providing substance use disorder and mental health services to
p.000845: homeless individ- uals;
p.000845: (4) entities that demonstrate experience in providing hous- ing for individuals in treatment for or in recovery from
p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
p.000845: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000845: shall give priority to applicants that—
p.000845: (1) propose to provide alcohol and drug prevention or treat- ment services on reservations;
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p.000847: 847
p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
p.000847: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000847: submit, in the ap- plication for such grant, a plan for the evaluation of any project un- dertaken with funds provided
p.000847: under this section. Such entity shall provide the Secretary with periodic evaluations of the progress of such
p.000847: project and such evaluation at the completion of such project as the Secretary determines to be appropriate.
p.000847: The final evaluation submitted by such entity shall include a recommendation as to whether such project shall
p.000847: continue.
p.000847: (f) REPORT.—Not later than 3 years after the date of the enact- ment of this section and annually thereafter,
p.000847: the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of
p.000847: the Senate, a report describing the services provided pursuant to this section.
p.000847: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000847: $15,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 and 2003.
p.000847: PART B—CENTERS AND PROGRAMS
p.000847: Subpart 1—Center for Substance Abuse Treatment
p.000847: CENTER FOR SUBSTANCE ABUSE TREATMENT 6
p.000847: SEC. 507. ø290bb¿ (a) ESTABLISHMENT.—There is established in the Administration a Center for Substance
p.000847: Abuse Treatment (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000847: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000847: individ- uals with extensive experience or academic qualifications in the treatment of substance use
p.000847: disorders or in the evaluation of sub- stance use disorder treatment systems.
p.000847: (b) DUTIES.—The Director of the Center shall—
p.000847: (1) administer the substance use disorder treatment block grant program authorized in section 1921;
p.000847: (2) ensure that emphasis is placed on children and adoles- cents in the development of treatment programs;
p.000847: (3) collaborate with the Attorney General to develop pro- grams to provide substance use disorder
p.000847: treatment services to individuals who have had contact with the Justice system, es- pecially adolescents;
p.000847: (4) collaborate with the Director of the Center for Sub- stance Abuse Prevention in order to provide
p.000847: outreach services to identify individuals in need of treatment services, with em-
p.000847:
p.000847:
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p.000847: January 30, 2020
p.000847: 6 Section 4 of Public Law 108–358 (118 Stat. 1664) authorizes the Secretary of Health and Human Services
p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000847:
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: (15) in cooperation with the Secretary, implement and dis- seminate, as appropriate, the recommendations in the
p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
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p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
p.000851: (3) providing such other information as the Director deter- mines to be appropriate.
p.000851: (l) REQUIREMENT OF APPLICATION.—The Director may make an award under subsection (a) only if an application for
p.000851: the award is submitted to the Director containing such agreements, and the ap- plication is in such form, is
p.000851: made in such manner, and contains such other agreements and such assurances and information as the Director
p.000851: determines to be necessary to carry out this section.
p.000851: (m) ALLOCATION OF AWARDS.—In making awards under sub- section (a), the Director shall give priority to
p.000851: an applicant that agrees to use the award for a program serving an area that is a rural area, an area
p.000851: designated under section 332 by the Secretary as a health professional shortage area, or an area
p.000851: determined by
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000853: 853
p.000853: PUBLIC HEALTH SERVICE ACT
p.000853: Sec. 508
p.000853:
p.000853: the Director to have a shortage of family-based substance use dis- order treatment options.
p.000853: (n) DURATION OF AWARD.—The period during which payments are made to an entity from an award under subsection
p.000853: (a) may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Director of the
p.000853: payments and subject to the availability of appropriations for the fiscal year involved to make the payments.
p.000853: This subsection may not be construed to establish a limitation on the number of awards under such subsection
p.000853: that may be made to an entity.
p.000853: (o) EVALUATIONS; DISSEMINATION OF FINDINGS.—The Director shall, directly or through contract, provide for
p.000853: the conduct of eval- uations of programs carried out pursuant to subsection (a). The Di- rector shall disseminate to
p.000853: the States the findings made as a result of the evaluations.
p.000853: (p) REPORTS TO CONGRESS.—Not later than October 1, 1994, the Director shall submit to the Committee on
p.000853: Energy and Com- merce of the House of Representatives, and to the Committee on Labor and Human Resources
p.000853: of the Senate, a report describing pro- grams carried out pursuant to this section (other than subsection
p.000853: (r)). Every 2 years thereafter, the Director shall prepare a report describing such programs carried out
p.000853: during the preceding 2 years, and shall submit the report to the Assistant Secretary for inclusion in the biennial
p.000853: report under section 501(m). Each report under this subsection shall include a summary of any evaluations
p.000853: conducted under subsection (m) during the period with respect to which the report is prepared.
p.000853: (q) DEFINITIONS.—For purposes of this section:
p.000853: (1) The term ‘‘authorized services’’ means treatment serv- ices and supplemental services.
p.000853: (2) The term ‘‘eligible woman’’ means a woman who has been admitted to a program operated pursuant to
p.000853: subsection (a).
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p.000853: (3) The term ‘‘funding agreement’’, with respect to an award under subsection (a), means that the Director may
p.000853: make the award only if the applicant makes the agreement involved.
p.000853: (4) The term ‘‘treatment services’’ means treatment for a substance use disorder, including the counseling
p.000853: and services described in subsection (c)(2).
p.000853: (5) The term ‘‘supplemental services’’ means the services described in subsection (d).
p.000853: (r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.—
p.000853: (1) IN GENERAL.—From amounts made available under subsection (s), the Director of the Center for
p.000853: Substance Abuse Treatment shall carry out a pilot program under which com- petitive grants are made by
p.000853: the Director to State substance abuse agencies—
p.000853: (A) to enhance flexibility in the use of funds designed to support family-based services for
p.000853: pregnant and postpartum women with a primary diagnosis of a sub- stance use disorder, including opioid use
p.000853: disorders;
p.000853: (B) to help State substance abuse agencies address identified gaps in services furnished to such women
p.000853: along
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000853: Sec. 508 PUBLIC HEALTH SERVICE ACT 854
p.000853:
p.000853: the continuum of care, including services provided to women in nonresidential-based settings; and
p.000853: (C) to promote a coordinated, effective, and efficient State system managed by State substance abuse
p.000853: agencies by encouraging new approaches and models of service de- livery.
p.000853: (2) REQUIREMENTS.—In carrying out the pilot program under this subsection, the Director shall—
p.000853: (A) require State substance abuse agencies to submit to the Director applications, in such form and manner and
p.000853: containing such information as specified by the Director, to be eligible to receive a grant under the program;
p.000853: (B) identify, based on such submitted applications, State substance abuse agencies that are eligible for
p.000853: such grants;
p.000853: (C) require services proposed to be furnished through such a grant to support family-based treatment and
p.000853: other services for pregnant and postpartum women with a pri- mary diagnosis of a substance use
p.000853: disorder, including opioid use disorders;
p.000853: (D) not require that services furnished through such a grant be provided solely to women that reside in facilities;
p.000853: (E) not require that grant recipients under the pro- gram make available through use of the grant all the serv-
p.000853: ices described in subsection (d); and
p.000853: (F) consider not applying the requirements described in paragraphs (1) and (2) of subsection (f) to an applicant,
p.000853: depending on the circumstances of the applicant.
p.000853: (3) REQUIRED SERVICES.—
p.000853: (A) IN GENERAL.—The Director shall specify a min- imum set of services required to be made available to eligi-
p.000853: ble women through a grant awarded under the pilot pro- gram under this subsection. Such minimum set of
p.000853: serv- ices—
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p.000853: (i) shall include the services requirements de- scribed in subsection (c) and be based on the rec-
p.000853: ommendations submitted under subparagraph (B); and
p.000853: (ii) may be selected from among the services de- scribed in subsection (d) and include other services as
p.000853: appropriate.
p.000853: (B) STAKEHOLDER INPUT.—The Director shall convene and solicit recommendations from stakeholders, including
p.000853: State substance abuse agencies, health care providers, per- sons in recovery from substance abuse, and other
p.000853: appro- priate individuals, for the minimum set of services de- scribed in subparagraph (A).
p.000853: (4) DURATION.—The pilot program under this subsection shall not exceed 5 years.
p.000853: (5) EVALUATION AND REPORT TO CONGRESS.—
p.000853: (A) IN GENERAL.—The Director of the Center for Be- havioral Health Statistics and Quality shall evaluate
p.000853: the pilot program at the conclusion of the first grant cycle funded by the pilot program.
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: 855
p.000855: PUBLIC HEALTH SERVICE ACT
p.000855: Sec. 509
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p.000855: (B) REPORT.—The Director of the Center for Behav- ioral Health Statistics and Quality, in coordination
p.000855: with the Director of the Center for Substance Abuse Treatment shall submit to the relevant committees of
p.000855: jurisdiction of the House of Representatives and the Senate a report on the evaluation under subparagraph
p.000855: (A). The report shall include, at a minimum—
p.000855: (i) outcomes information from the pilot program, including any resulting reductions in the use of alcohol and
p.000855: other drugs;
p.000855: (ii) engagement in treatment services;
p.000855: (iii) retention in the appropriate level and dura- tion of services;
p.000855: (iv) increased access to the use of medications ap- proved by the Food and Drug Administration for the
p.000855: treatment of substance use disorders in combination with counseling; and
p.000855: (v) other appropriate measures.
p.000855: (C) RECOMMENDATION.—The report under subpara- graph (B) shall include a recommendation by the Director
p.000855: of the Center for Substance Abuse Treatment as to wheth- er the pilot program under this subsection should be
p.000855: ex- tended.
p.000855: (6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For pur- poses of this subsection, the term ‘‘State substance abuse
p.000855: agen- cy’’ means, with respect to a State, the agency in such State that manages the Substance Abuse
p.000855: Prevention and Treatment Block Grant under part B of title XIX.
p.000855: (s) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000855: to be appropriated
p.000855: $29,931,000 for each of fiscal years 2019 through 2023. Of the amounts made available for a year
p.000855: pursuant to theprevious sen- tence to carry out this section, not more than25 percent of such amounts
p.000855: shall be made available for suchyear to carry out sub- section (r), other than paragraph (5) ofsuch
p.000855: subsection. Notwith- standing the preceding sentence, nofunds shall be made available to carry out subsection
p.000855: (r) fora fiscal year unless the amount made available to carry outthis section for such fiscal year is more
p.000855: than the amount madeavailable to carry out this section for fiscal year 2016.
p.000855: SEC. 509. ø290bb–2¿ PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF REGIONAL AND NATIONAL SIGNIFICANCE.
p.000855: (a) PROJECTS.—The Secretary shall address priority substance use disorder treatment needs of regional and
p.000855: national significance (as determined under subsection (b)) through the provision of or through assistance
p.000855: for—
p.000855: (1) knowledge development and application projects for treatment and rehabilitation and the conduct or
p.000855: support of evaluations of such projects;
p.000855: (2) training and technical assistance; and
p.000855: (3) targeted capacity response programs that permit States, local governments, communities, and Indian
p.000855: tribes and tribal organizations (as the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in
p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000855:
p.000855: mination and Education Assistance Act) to focus on emerging trends in substance abuse and co-occurrence
p.000855: of substance use disorders with mental illness or other conditions.
p.000855: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000855: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000855: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000855: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000855: public or nonprofit private entities.
p.000855: (b) PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS.—
p.000855: (1) IN GENERAL.—Priority substance use disorder treat- ment needs of regional and national significance shall be
p.000855: deter- mined by the Secretary after consultation with States and other interested groups. The Secretary
p.000855: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000855: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000855: con- sideration to promoting the integration of substance use dis- order treatment services into primary health
p.000855: care systems.
p.000855: (c) REQUIREMENTS.—
p.000855: (1) IN GENERAL.—Recipients of grants, contracts, or cooper- ative agreements under this section shall comply with
p.000855: informa- tion and application requirements determined appropriate by the Secretary.
p.000855: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000855: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000855: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000855: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
p.000855: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000855: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
p.000855: matching funds may be provided directly or through donations from public or private entities and may be in
p.000855: cash or in kind, fairly evaluated, including plant, equipment, or services.
p.000855: (4) MAINTENANCE OF EFFORT.—With respect to activities for which a grant, contract, or cooperative agreement
p.000855: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000855: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.000855: less than the level of such expenditures main- tained by the entity for the fiscal year preceding the fiscal year for
p.000855: which the entity receives such a grant, contract, or coopera- tive agreement.
p.000855: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000855: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: 857
p.000857: PUBLIC HEALTH SERVICE ACT
p.000857: Sec. 513
p.000857:
p.000857: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000857: programs to dissemi- nate and apply the findings of the knowledge development and ap- plication, training and technical
p.000857: assistance programs, and targeted capacity response programs under this section to the general pub- lic, to
p.000857: health professionals and other interested groups. The Sec- retary shall make every effort to provide linkages
p.000857: between the find- ings of supported projects and State agencies responsible for car- rying out substance
p.000857: use disorder prevention and treatment pro- grams.
p.000857: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000857: $333,806,000 for each of fiscal years 2018 through 2022.
p.000857: ACTION BY NATIONAL INSTITUTE ON DRUG ABUSE AND STATES CONCERNING MILITARY FACILITIES
p.000857: SEC. 513. 7 ø290bb–6¿ (a) CENTER FOR SUBSTANCE ABUSE
p.000857: TREATMENT.—The Director of the Center for Substance Abuse Treatment shall—
p.000857: (1) coordinate with the agencies represented on the Com- mission on Alternative Utilization of Military
p.000857: Facilities the uti- lization of military facilities or parts thereof, as identified by such Commission,
p.000857: established under the National Defense Au- thorization Act of 1989, that could be utilized or renovated to
p.000857: house nonviolent persons for drug treatment purposes;
p.000857: (2) notify State agencies responsible for the oversight of drug abuse treatment entities and programs of the
p.000857: availability of space at the installations identified in paragraph (1); and
p.000857: (3) assist State agencies responsible for the oversight of drug abuse treatment entities and programs in
p.000857: developing methods for adapting the installations described in paragraph
p.000857: (1) into residential treatment centers.
p.000857: (b) STATES.—With regard to military facilities or parts thereof, as identified by the Commission on Alternative
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p.000857: for individuals receiving treatment at such facilities.
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p.000857: January 30, 2020
p.000857: 7 Sections 510 through 512 were repealed by section 3301(c) of Public Law 106–310 (114 Stat.
p.000857: 1209).
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: Sec. 514 PUBLIC HEALTH SERVICE ACT 858
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p.000857: (c) RESERVATION OF SPACE.—Prior to notifying States of the availability of space at military facilities
p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
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p.000859: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or cooperative agreement, a plan for the evaluation of any
p.000859: project undertaken with funds provided under this section. Such entity shall provide the Secretary with
p.000859: periodic evaluations of the progress of such project and such eval- uation at the completion of such
p.000859: project as the Secretary deter- mines to be appropriate.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000859: $29,605,000 for each of fiscal years 2018 through 2022.
p.000859: øSection 514A was repealed by section 9017 of Public Law 114–255.¿
p.000859: SEC. 514B. ø290bb–10¿ EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND INTERVENTIONS DEMONSTRA-
p.000859: TION.
p.000859: (a) GRANTS TO EXPAND ACCESS.—
p.000859: (1) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements to
p.000859: State substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes and tribal
p.000859: organizations (as defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act) that have
p.000859: a high rate, or have had a rapid increase, in the use of heroin or other opioids, in order to permit
p.000859: such entities to expand activities, including an ex- pansion in the availability of evidence-based
p.000859: medication-as- sisted treatment and other clinically appropriate services, with respect to the treatment of
p.000859: addiction in the specific geo- graphical areas of such entities where there is a high rate or rapid
p.000859: increase in the use of heroin or other opioids, such as in rural areas.
p.000859: (2) NATURE OF ACTIVITIES.—Funds awarded under para- graph (1) shall be used for activities that are based on
p.000859: reliable scientific evidence of efficacy in the treatment of problems re- lated to heroin or other opioids.
p.000859: (b) APPLICATION.—To be eligible for a grant, contract, or coop- erative agreement under subsection (a),
p.000859: an entity shall submit an application to the Secretary at such time, in such manner, and ac- companied by such
p.000859: information as the Secretary may reasonably require.
p.000859: (c) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or agreement a plan for the eval- uation of any project
p.000859: undertaken with funds provided under this section. Such entity shall provide the Secretary with periodic eval-
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p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000859: Sec. 515 PUBLIC HEALTH SERVICE ACT 860
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p.000859: shall take into account the unique needs of rural communities, in- cluding communities with an incidence of
p.000859: individuals with opioid use disorder that is above the national average and communities with a shortage of
p.000859: prevention and treatment services.
p.000859: (e) ADDITIONAL ACTIVITIES.—In administering grants, con- tracts, and cooperative agreements under
p.000859: subsection (a), the Sec- retary shall—
p.000859: (1) evaluate the activities supported under such sub- section;
p.000859: (2) disseminate information, as appropriate, derived from evaluations as the Secretary considers appropriate;
p.000859: (3) provide States, Indian tribes and tribal organizations, and providers with technical assistance in
p.000859: connection with the provision of treatment of problems related to heroin and other opioids; and
p.000859: (4) fund only those applications that specifically support recovery services as a critical component of
p.000859: the program in- volved.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000859: $25,000,000 for each of fiscal years 2017 through 2021.
p.000859: Subpart 2—Center for Substance Abuse Prevention
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p.000859: January 30, 2020
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p.000859: CENTER FOR SUBSTANCE ABUSE PREVENTION
p.000859: SEC. 515. ø290bb–21¿ (a) There is established in the Adminis- tration a Center for Substance Abuse Prevention
p.000859: (hereafter re- ferred to in this part as the ‘‘Prevention Center’’). The Prevention Center shall be
p.000859: headed by a Director appointed by the Secretary from individuals with extensive experience or academic
p.000859: qualifica- tions in the prevention of drug or alcohol abuse.
p.000859: (b) The Director of the Prevention Center shall—
p.000859: (1) sponsor regional workshops on the prevention of drug and alcohol abuse through the reduction of risk
p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
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p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
p.000861: (B) promoting the integration of substance use dis- order prevention information and activities into
p.000861: primary health care systems; and
p.000861: (C) substance use disorder prevention among high-risk groups.
p.000861: (c) REQUIREMENTS.—
p.000861: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000861: infor- mation and application requirements determined appropriate by the Secretary.
p.000861: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000861: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000861: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000861: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
p.000861: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000861: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
p.000861: matching funds may be provided directly or through donations from public or private entities and may be in
p.000861: cash or in kind, fairly evaluated, including plant, equipment, or services.
p.000861: (4) MAINTENANCE OF EFFORT.—With respect to activities for which a grant, contract, or cooperative agreement
p.000861: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000861: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
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p.000863: PUBLIC HEALTH SERVICE ACT
p.000863: Sec. 519B
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p.000863: for which the entity receives such a grant, contract, or coopera- tive agreement.
p.000863: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000863: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000863: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000863: programs to dissemi- nate the findings of the knowledge development and application, training and technical
p.000863: assistance programs, and targeted capacity response programs under this section to the general public and
p.000863: to health professionals. The Secretary shall make every effort to pro- vide linkages between the findings of supported
p.000863: projects and State agencies responsible for carrying out substance use disorder pre- vention and treatment
p.000863: programs.
p.000863: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000863: $211,148,000 for each of fiscal years 2018 through 2022.
p.000863: øSection 517 was repealed by section 9017 of Public Law 114–
p.000863: 255. Section 518 was repealed by section 3202(b) of Public Law 106–310 (114 Stat. 1210). Section 519A
p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
p.000863: (3) The term ‘‘youth’’ means persons under the age of 21.
p.000863: (4) The term ‘‘IOM report’’ means the report released in September 2003 by the National Research Council,
p.000863: Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collec- tive Responsibility’’.
p.000863: (b) SENSE OF CONGRESS.—It is the sense of the Congress that:
p.000863: (1) A multi-faceted effort is needed to more successfully ad- dress the problem of underage drinking in the
p.000863: United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to
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p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
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p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
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p.000867: broadcasting, and evaluation of the campaign referred to in paragraph (1), and to detail in the report the
p.000867: effectiveness of the campaign in reduc- ing underage drinking, the need for and likely effectiveness of an expanded
p.000867: adult-oriented media campaign, and the feasi- bility and the likely effectiveness of a national
p.000867: youth-focused media campaign to combat underage drinking.
p.000867: (3) CONSULTATION REQUIREMENT.—In carrying out the media campaign, the Secretary shall direct the entity
p.000867: carrying out the national adult-oriented media public service campaign to consult with interested parties
p.000867: including both the alcohol beverage industry and public health and consumer groups. The progress of this
p.000867: consultative process is to be covered in the re- port under paragraph (2).
p.000867: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection,
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (e) INTERVENTIONS.—
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p.000867: Sec. 519B PUBLIC HEALTH SERVICE ACT 868
p.000867:
p.000867: (1) COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO PREVENT UNDERAGE DRINKING.—
p.000867: (A) AUTHORIZATION OF PROGRAM.—The Assistant Sec- retary for Mental Health and Substance Use, in consulta-
p.000867: tion with the Director of the Office of National Drug Con- trol Policy, shall award, if the Assistant Secretary
p.000867: deter- mines that the Department of Health and Human Services is not currently conducting activities that duplicate
p.000867: activi- ties of the type described in this subsection, ‘‘enhancement grants’’ to eligible entities to design, test,
p.000867: evaluate and dis- seminate effective strategies to maximize the effectiveness of community-wide approaches to
p.000867: preventing and reducing underage drinking. This subsection is subject to the avail- ability of appropriations.
p.000867: (B) PURPOSES.—The purposes of this paragraph are
p.000867: to—
p.000867: (i) prevent and reduce alcohol use among youth in communities throughout the United States;
p.000867: (ii) strengthen collaboration among communities, the Federal Government, and State, local, and tribal
p.000867: governments;
p.000867: (iii) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;
p.000867: (iv) serve as a catalyst for increased citizen par- ticipation and greater collaboration among all
p.000867: sectors and organizations of a community that first dem- onstrates a long-term commitment to reducing
p.000867: alcohol use among youth;
p.000867: (v) disseminate to communities timely information regarding state-of-the-art practices and initiatives that have proven
p.000867: to be effective in preventing and reducing alcohol use among youth; and
...

p.000869: (I) AUTHORIZATION OF APPROPRIATIONS.—There are au- thorized to be appropriated to carry out this paragraph
p.000869: $5,000,000 for each of the fiscal years 2018 through 2022.
p.000869: (2) GRANTS DIRECTED AT PREVENTING AND REDUCING ALCO- HOL ABUSE AT INSTITUTIONS OF HIGHER EDUCATION.—
p.000869: (A) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to eligible entities to enable the entities to
p.000869: prevent and reduce the rate of underage alcohol consump- tion including binge drinking among students at
p.000869: institu- tions of higher education.
p.000869: (B) APPLICATIONS.—An eligible entity that desires to receive a grant under this paragraph shall submit an
p.000869: ap- plication to the Secretary at such time, in such manner, and accompanied by such information as the
p.000869: Secretary may require. Each application shall include—
p.000869: (i) a description of how the eligible entity will work to enhance an existing, or where none exists to
p.000869: build a, statewide coalition;
p.000869: (ii) a description of how the eligible entity will tar- get underage students in the State;
p.000869: (iii) a description of how the eligible entity intends to ensure that the statewide coalition is actually im-
p.000869: plementing the purpose of this section and moving to- ward indicators described in subparagraph (D);
p.000869: (iv) a list of the members of the statewide coali- tion or interested parties involved in the work of
p.000869: the eligible entity;
p.000869: (v) a description of how the eligible entity intends to work with State agencies on substance abuse pre-
p.000869: vention and education;
p.000869: (vi) the anticipated impact of funds provided under this paragraph in preventing and reducing the
p.000869: rates of underage alcohol use;
p.000869: (vii) outreach strategies, including ways in which the eligible entity proposes to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000869: Sec. 519B PUBLIC HEALTH SERVICE ACT 870
p.000869:
p.000869: (I) reach out to students and community stakeholders;
p.000869: (II) promote the purpose of this paragraph;
p.000869: (III) address the range of needs of the stu- dents and the surrounding communities; and
p.000869: (IV) address community norms for underage students regarding alcohol use; and
p.000869: (viii) such additional information as required by the Secretary.
p.000869: (C) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000869: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph (B).
p.000869: (D) ACCOUNTABILITY.—On the date on which the Sec- retary first publishes a notice in the Federal Register solic-
p.000869: iting applications for grants under this paragraph, the Sec- retary shall include in the notice achievement
p.000869: indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
...

p.000869: (iii) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Education.
p.000869: (iv) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Common- wealth of
p.000869: Puerto Rico.
p.000869: (v) STATEWIDE COALITION.—The term ‘‘statewide coalition’’ means a coalition that—
p.000869: (I) includes, but is not limited to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: 871
p.000871: PUBLIC HEALTH SERVICE ACT
p.000871: Sec. 519B
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p.000871: January 30, 2020
p.000871: (aa) institutions of higher education with- in a State; and
p.000871: (bb) a nonprofit group, a community un- derage drinking prevention coalition, or an- other substance abuse
p.000871: prevention group with- in a State; and
p.000871: (II) works toward lowering the alcohol abuse rate by targeting underage students at institu- tions of
p.000871: higher education throughout the State and in the surrounding communities.
p.000871: (vi) SURROUNDING COMMUNITY.—The term ‘‘sur- rounding community’’ means the community—
p.000871: (I) that surrounds an institution of higher education participating in a statewide coalition;
p.000871: (II) where the students from the institution of higher education take part in the community; and
p.000871: (III) where students from the institution of higher education live in off-campus housing.
p.000871: (G) ADMINISTRATIVE EXPENSES.—Not more than 5 per- cent of a grant under this paragraph may be expended for
p.000871: administrative expenses.
p.000871: (H) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this
p.000871: paragraph
p.000871: $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
p.000871: (f) ADDITIONAL RESEARCH.—
p.000871: (1) ADDITIONAL RESEARCH ON UNDERAGE DRINKING.—
p.000871: (A) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, collect data, and
p.000871: conduct or support research that is not duplicative of research cur- rently being conducted or supported by
p.000871: the Department of Health and Human Services, on underage drinking, with respect to the following:
...

p.000873: or nonprofit private entities for the purposes of establishing not more than four centers of excellence to study
p.000873: techniques for the prevention of fetal alcohol syndrome and alcohol-related birth defects and adaptations of inno-
p.000873: vative clinical interventions and service delivery improvements for the provision of comprehensive services to
p.000873: individuals with fetal al- cohol syndrome or alcohol-related birth defects and their families and for providing
p.000873: training on such conditions.
p.000873: (b) USE OF FUNDS.—An award under subsection (a) may be used to—
p.000873: (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for
p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
p.000873: (3) provide technical assistance to communities who do not have a comprehensive system of care for such
p.000873: individuals and their families;
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000873:
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p.000873: Sec. 520 PUBLIC HEALTH SERVICE ACT 874
p.000873:
p.000873: (4) train community leaders, mental health and substance abuse professionals, families, law enforcement
p.000873: personnel, judges, health professionals, persons working in financial as- sistance programs, social service
p.000873: personnel, child welfare pro- fessionals, and other service providers on the implications of fetal alcohol
p.000873: syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
p.000873: (5) develop innovative techniques for preventing alcohol use by women in child bearing years; 9
p.000873: (6) perform other functions, to the extent authorized by the Secretary after consideration of recommendations made by
p.000873: the National Task Force on Fetal Alcohol Syndrome.
p.000873: (c) REPORT.—
p.000873: (1) IN GENERAL.—A recipient of an award under subsection
p.000873: (a) shall at the end of the period of funding report to the Sec- retary on any innovative techniques that have been
p.000873: discovered for preventing alcohol use among women of child bearing years.
p.000873: (2) DISSEMINATION OF FINDINGS.—The Secretary shall upon receiving a report under paragraph (1) disseminate the
p.000873: find- ings to appropriate public and private entities.
p.000873: (d) DURATION OF AWARDS.—With respect to an award under subsection (a), the period during which
p.000873: payments under such award are made to the recipient may not exceed 5 years.
...

p.000877: all ages, par- ticularly among groups that are at a high risk for suicide;
p.000877: (2) ensuring the surveillance of suicide early intervention and prevention strategies for all ages,
p.000877: particularly among groups that are at a high risk for suicide;
p.000877: (3) studying the costs and effectiveness of statewide and tribalsuicide early intervention and prevention
p.000877: strategies in order to provide information concerning relevant issues of im- portance to State, tribal, and
p.000877: national policymakers;
p.000877: (4) further identifying and understanding causes and asso- ciated risk factors for suicide;
p.000877: (5) analyzing the efficacy of new and existing suicide early intervention and prevention techniques and technology;
p.000877: (6) ensuring the surveillance of suicidal behaviors and nonfatal suicidal attempts;
p.000877: (7) studying the effectiveness of State-sponsored statewide and tribal suicide early intervention and prevention
p.000877: strategies on the overall wellness and health promotion strategies related to suicide attempts;
p.000877: (8) promoting the sharing of data regarding suicide with Federal agencies involved with suicide early
p.000877: intervention and prevention, and State-sponsored statewide or tribal suicide early intervention and prevention
p.000877: strategies for the purpose of identifying previously unknown mental health causes and asso- ciated risk factors for
p.000877: suicide;
p.000877: (9) evaluating and disseminating outcomes and best prac- tices of mental health and substance use
p.000877: disorder services at institutions of higher education; and
p.000877: (10) conducting other activities determined appropriate by the Secretary.
p.000877: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000877: to be appropriated
p.000877: $5,988,000 for each of fiscal years 2018 through 2022.
p.000877: (d) ANNUAL REPORT.—Not later than 2 years after the date of enactment of this subsection, the Secretary
p.000877: shall submit to Con- gress a report on the activities carried out by the center established under subsection (a)
p.000877: during the year involved, including the poten- tial effects of such activities, and the States, organizations, and in-
p.000877: stitutions that have worked with the center.
p.000877: øSection 520D was repealed by section 9017 of Public Law 114–255.¿
p.000877: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: 879
p.000879: PUBLIC HEALTH SERVICE ACT
p.000879: Sec. 520E
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p.000879: January 30, 2020
p.000879: SEC. 520E. ø290bb–36¿ YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
p.000879: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance
p.000879: Use, shall award grants or cooperative agreements to eligible entities to—
p.000879: (1) develop and implement State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention strate- gies in schools, educational institutions, juvenile justice sys- tems, substance use
p.000879: disorder programs, mental health pro- grams, foster care systems, and other child and youth support organizations;
p.000879: (2) support public organizations and private nonprofit or- ganizations actively involved in State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies and in the development
p.000879: and continuation of State-spon- sored statewide youth suicide early intervention and preven- tion strategies;
p.000879: (3) provide grants to institutions of higher education to co- ordinate the implementation of State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies;
p.000879: (4) collect and analyze data on State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention serv- ices that can be used to monitor the effectiveness of such serv- ices and for research, technical
p.000879: assistance, and policy develop- ment; and
p.000879: (5) assist eligible entities, through State-sponsored state- wide or tribal youth suicide early
p.000879: intervention and prevention strategies, in achieving targets for youth suicide reductions under title V of the
p.000879: Social Security Act.
p.000879: (b) ELIGIBLE ENTITY.—
...

p.000879: State and among the populations of focus, including rates of suicide determined by the Centers for Disease
p.000879: Control and Prevention for the State or population of focus.
p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: January 30, 2020
p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
...

p.000883: tion program such entity proposes will—
p.000883:
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p.000883: January 30, 2020
p.000883: 10 The probable intent of the Congress is that the heading be ‘‘SUICIDE PREVENTION FOR YOUTH’’. See the amendment
p.000883: described in section 3(b)(1)(A) of Public Law 108–355 (118 Stat. 1407). The amendment cannot be executed
p.000883: because the matter in the heading to be struck does not appear, as the amendatory instruction used the wrong
p.000883: font. The amendment referred to ‘‘CHILDREN AND ADOLESCENTS’’ rather than ‘‘CHILDREN AND ADOLESCENTS’’. (The
p.000883: amendment is directed to section ‘‘520E’’. Section 520E–1 above formerly was section 520E, and was redesignated by
p.000883: section 3(b)(2) of such Public Law.)
p.000883: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
p.000883:
p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
p.000883: (B) in the case of a consortium of States, receive the sup- port of all States involved;
p.000883: (2) provide for the timely assessment, treatment, or refer- ral for mental health or substance abuse
p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
...

p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
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p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
p.000885: with the Secretary of Education, may award grants on a competitive basis to institutions of higher education
p.000885: to enhance services for students with mental health or substance use disorders that can lead to school
p.000885: failure, such as depression, substance use disorders, and sui- cide attempts, prevent mental and substance use
p.000885: disorders, reduce stigma, and improve the identification and treatment for students at risk, so that students
p.000885: will successfully complete their studies.
p.000885: (b) USE OF FUNDS.—The Secretary may not make a grant to an institution of higher education under this section
p.000885: unless the in- stitution agrees to use the grant only for one or more of the fol- lowing:
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p.000885: (1) Educating students, families, faculty, and staff to in- crease awareness of mental and substance use
p.000885: disorders.
p.000885: (2) The operation of hotlines.
p.000885: (3) Preparing informational material.
p.000885: (4) Providing outreach services to notify students about available mental and substance use disorder services.
p.000885: (5) Administering voluntary mental and substance use dis- order screenings and assessments.
p.000885: (6) Supporting the training of students, faculty, and staff to respond effectively to students with
p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
p.000887: (1) A description of the population to be targeted by the program carried out under the grant, including
p.000887: veterans when- ever possible and appropriate, and of identified mental and substance use disorder needs of
p.000887: students at the institution of higher education.
p.000887: (2) A description of Federal, State, local, private, and insti- tutional resources currently available to address the
p.000887: needs de- scribed in paragraph (1) at the institution of higher education, which may include, as appropriate and in
p.000887: accordance with sub- section (b)(7), a plan to seek input from relevant stakeholders in the community,
p.000887: including appropriate public and private en- tities, in order to carry out the program under the grant.
p.000887: (3) A description of the outreach strategies of the institu- tion of higher education for promoting
p.000887: access to services, in- cluding a proposed plan for reaching those students most in need of mental health
p.000887: services.
p.000887: (4) A plan to evaluate program outcomes, including a de- scription of the proposed use of funds, the
p.000887: program objectives, and how the objectives will be met.
p.000887: (5) An assurance that the institution will submit a report to the Secretary each fiscal year on the
p.000887: activities carried out with the grant and the results achieved through those activi- ties.
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p.000887: in an amount that is not less than $1 for each $1 of Federal funds provided in the grant, toward the costs
p.000887: of activities car- ried out with the grant (as described in subsection (b)) and other activities by the
p.000887: institution to reduce student mental health and substance use disorders.
p.000887: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required under paragraph (1) may be in cash
p.000887: or in kind. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
p.000887: extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.000887: contributions.
p.000887: (3) WAIVER.—The Secretary may waive the requirement established in paragraph (1) with respect to an
p.000887: institution of higher education if the Secretary determines that extraor- dinary need at the institution
p.000887: justifies the waiver.
p.000887: (f) REPORTS.—For each fiscal year that grants are awarded under this section, the Secretary shall conduct
p.000887: a study on the re- sults of the grants and submit to the Congress a report on such re- sults that includes the
p.000887: following:
p.000887: (1) An evaluation of the grant program outcomes, includ- ing a summary of activities carried out with the grant
p.000887: and the results achieved through those activities.
p.000887: (2) Recommendations on how to improve access to mental health and substance use disorder services at
p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
p.000887: (g) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000887: section 101 of the Higher Education Act of 1965.
p.000887: (h) TECHNICAL ASSISTANCE.—The Secretary may provide tech- nical assistance to grantees in carrying out this
p.000887: section.
p.000887: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000887: to be appropriated
p.000887: $7,000,000 for each of fiscal years 2018 through 2022.
p.000887: SEC. 520E–3. ø290bb–36c¿ NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.000887: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Suicide
p.000887: Prevention Lifeline program (referred to in this section as the ‘‘program’’), authorized under section 520A
p.000887: and in effect prior to the date of enactment of the Helping Families in Mental Health Crisis Reform Act of
p.000887: 2016.
p.000887: (b) ACTIVITIES.—In maintaining the program, the activities of the Secretary shall include—
p.000887: (1) coordinating a network of crisis centers across the United States for providing suicide prevention and
p.000887: crisis inter- vention services to individuals seeking help at any time, day or night;
p.000887: (2) maintaining a suicide prevention hotline to link callers to local emergency, mental health, and social
p.000887: services re- sources; and
p.000887: (3) consulting with the Secretary of Veterans Affairs to en- sure that veterans calling the suicide prevention
p.000887: hotline have access to a specialized veterans’ suicide prevention hotline.
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000889: PUBLIC HEALTH SERVICE ACT
p.000889: Sec. 520F
p.000889:
p.000889: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $7,198,000
p.000889: for each of fiscal years 2018 through 2022.
p.000889: SEC. 520E–4. ø290bb-36d¿ TREATMENT REFERRAL ROUTING SERVICE.
p.000889: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Treatment
p.000889: Referral Routing Service (referred to in this section as the ‘‘Routing Service’’) to as- sist individuals and
p.000889: families in locating mental and substance use disorders treatment providers.
p.000889: (b) ACTIVITIES OF THE SECRETARY.—To maintain the Routing Service, the activities of the Assistant
p.000889: Secretary shall include ad- ministering—
p.000889: (1) a nationwide, telephone number providing year-round access to information that is updated on a
p.000889: regular basis re- garding local behavioral health providers and community- based organizations in a
p.000889: manner that is confidential, without requiring individuals to identify themselves, is in languages that
p.000889: include at least English and Spanish, and is at no cost to the individual using the Routing Service; and
p.000889: (2) an Internet website to provide a searchable, online treatment services locator of behavioral health
p.000889: treatment pro- viders and community-based organizations, which shall include information on the name, location,
p.000889: contact information, and basic services provided by such providers and organizations.
p.000889: (c) REMOVING PRACTITIONER CONTACT INFORMATION.—In the event that the Internet website described in
p.000889: subsection (b)(2) con- tains information on any qualified practitioner that is certified to prescribe
p.000889: medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act, the
p.000889: Assistant Sec- retary—
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p.000889: (A) promoting integration and coordination between local public and private entities engaged in crisis response,
p.000889: including first responders, emergency health care pro- viders, primary care providers, law enforcement,
p.000889: court sys- tems, health care payers, social service providers, and be- havioral health providers;
p.000889: (B) developing memoranda of understanding with pub- lic and private entities to implement crisis response serv-
p.000889: ices;
p.000889: (C) addressing gaps in community resources for crisis intervention and prevention; and
p.000889: (D) developing models for minimizing hospital re- admissions, including through appropriate discharge plan-
p.000889: ning.
p.000889: (3) BEDS DATABASE PLAN.—An application for a grant under subsection (a)(2) shall include a plan
p.000889: for developing, maintaining, or enhancing a real-time, Internet-based bed database to collect,
p.000889: aggregate, and display information about beds in inpatient psychiatric facilities and crisis stabilization
p.000889: units, and residential community mental health and residen- tial substance use disorder treatment facilities to
p.000889: facilitate the identification and designation of facilities for the temporary treatment of individuals in
p.000889: mental or substance use disorder crisis.
p.000889: (c) DATABASE REQUIREMENTS.—A bed database described in this section is a database that—
p.000889: (1) includes information on inpatient psychiatric facilities, crisis stabilization units, and residential
p.000889: community mental health and residential substance use disorder facilities in the State involved, including
p.000889: contact information for the facility or unit;
p.000889: (2) provides real-time information about the number of beds available at each facility or unit and, for
p.000889: each available bed, the type of patient that may be admitted, the level of se- curity provided, and any other
p.000889: information that may be nec- essary to allow for the proper identification of appropriate fa- cilities for
p.000889: treatment of individuals in mental or substance use disorder crisis; and
p.000889: (3) enables searches of the database to identify available beds that are appropriate for the treatment
p.000889: of individuals in mental or substance use disorder crisis.
p.000889: (d) EVALUATION.—An entity receiving a grant under subsection (a)(1) shall submit to the Secretary, at such time, in
p.000889: such manner, and containing such information as the Secretary may reasonably require, a report, including an
p.000889: evaluation of the effect of such grant on—
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p.000891: PUBLIC HEALTH SERVICE ACT
p.000891: Sec. 520G
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p.000891: (1) local crisis response services and measures for individ- uals receiving crisis planning and early
p.000891: intervention supports;
p.000891: (2) individuals reporting improved functional outcomes;
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p.000893: tributed among the geographical regions of the United States and between urban and rural populations.
p.000893: (h) TRAINING AND TECHNICAL ASSISTANCE.—Training and tech- nical assistance may be provided by the Secretary to
p.000893: assist a State, political subdivision of a State, Indian tribe, or tribal organization receiving a grant under
p.000893: subsection (a) in establishing and operating a diversion program.
p.000893: (i) EVALUATIONS.—The programs described in subsection (a) shall be evaluated not less than one time in every
p.000893: 12-month period using the methodology and outcome measures identified in the grant application.
p.000893: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000893: $4,269,000 for each of fiscal years 2018 through 2022.
p.000893: øSection 520H was repealed by section 9017 of Public Law 114–255.¿
p.000893: SEC. 520I. ø290bb–40¿ GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS MENTAL ILLNESS AND CO-OCCURRING
p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: Sec. 520J PUBLIC HEALTH SERVICE ACT 894
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p.000893: previously provided only mental health services or only sub- stance abuse services; and
p.000893: (6) to provide services in coordination with other existing public and private community programs.
p.000893: (d) CONDITION.—The Secretary shall ensure that a State, polit- ical subdivision of a State, Indian tribe, tribal
p.000893: organization, or pri- vate nonprofit organization that receives a grant, contract, or coop- erative agreement under
p.000893: subsection (a) maintains the level of effort necessary to sustain existing mental health and substance abuse
p.000893: programs for other populations served by mental health systems in the community.
p.000893: (e) DISTRIBUTION OF AWARDS.—The Secretary shall ensure that grants, contracts, or cooperative agreements awarded
p.000893: under sub- section (a) are equitably distributed among the geographical re- gions of the United States
p.000893: and between urban and rural popu- lations.
p.000893: (f) DURATION.—The Secretary shall award grants, contract, or cooperative agreements under this subsection
p.000893: for a period of not more than 5 years.
p.000893: (g) APPLICATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or
p.000893: private nonprofit organization that desires a grant, contract, or cooperative agreement under this subsection shall
p.000893: prepare and submit an application to the Secretary at such time, in such manner, and containing such
p.000893: information as the Secretary may require. Such application shall include a plan for the rigorous
p.000893: evaluation of activities funded with an award under such subsection, including a process and outcomes
p.000893: evalua- tion.
p.000893: (h) EVALUATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
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p.000895: (3) SPECIAL POPULATION.—The term ‘‘special population’’ means—
p.000895: (A) adults with a mental illness who have co-occurring physical health conditions or chronic diseases;
p.000895: (B) adults with a serious mental illness who have co- occurring physical health conditions or chronic
p.000895: diseases;
p.000895: (C) children and adolescents with a serious emotional disturbance with co-occurring physical health conditions
p.000895: or chronic diseases; or
p.000895: (D) individuals with a substance use disorder.
p.000895: (b) GRANTS AND COOPERATIVE AGREEMENTS.—
p.000895: (1) IN GENERAL.—The Secretary may award grants and co- operative agreements to eligible entities to support the
p.000895: im- provement of integrated care for primary care and behavioral health care in accordance with paragraph (2).
p.000895: (2) PURPOSES.—A grant or cooperative agreement awarded under this section shall be designed to—
p.000895: (A) promote full integration and collaboration in clin- ical practices between primary and behavioral health
p.000895: care;
p.000895: (B) support the improvement of integrated care models for primary care and behavioral health care to improve the
p.000895: overall wellness and physical health status of adults with a serious mental illness or children with a
p.000895: serious emo- tional disturbance; and
p.000895: (C) promote integrated care services related to screen- ing, diagnosis, prevention, and treatment of mental and
p.000895: substance use disorders, and co-occurring physical health conditions and chronic diseases.
p.000895: (c) APPLICATIONS.—
p.000895: (1) IN GENERAL.—An eligible entity seeking a grant or co- operative agreement under this section shall
p.000895: submit an appli- cation to the Secretary at such time, in such manner, and ac- companied by such
p.000895: information as the Secretary may require, including the contents described in paragraph (2).
p.000895: (2) CONTENTS.—The contents described in this paragraph are—
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p.000895: (A) a description of a plan to achieve fully collabo- rative agreements to provide services to
p.000895: special popu- lations;
p.000895: (B) a document that summarizes the policies, if any, that serve as barriers to the provision of
p.000895: integrated care, and the specific steps, if applicable, that will be taken to address such barriers;
p.000895: (C) a description of partnerships or other arrange- ments with local health care providers to provide
p.000895: services to special populations;
p.000895: (D) an agreement and plan to report to the Secretary performance measures necessary to evaluate patient
p.000895: out- comes and facilitate evaluations across participating projects; and
p.000895: (E) a plan for sustainability beyond the grant or coop- erative agreement period under subsection (e).
p.000895: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
p.000899: (D) patient and family satisfaction with program par- ticipation; and
p.000899: (2) provide appropriate information, training, and technical assistance to grant recipients under this section
p.000899: to help such
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: (e) AUTHORIZATION OF APPROPRIATIONS.—
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p.000903: (B) includes documentation that suitable housing for eligible homeless individuals will accompany the provision
p.000903: of services to such individuals;
p.000903: (3) describes the source of the non-Federal contributions described in section 523;
p.000903: (4) contains assurances that the non-Federal contributions described in section 523 will be available at the
p.000903: beginning of the grant period;
p.000903: (5) describe any voucher system that may be used to carry out this part; and
p.000903: (6) contain such other information or assurances as the Secretary may reasonably require.
p.000903: SEC. 527. ø290cc–27¿ DESCRIPTION OF INTENDED EXPENDITURES OF GRANT.
p.000903: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless—
p.000903: (1) as part of the application required in section 529, the State involved submits to the Secretary a
p.000903: description of the in- tended use for the fiscal year of the amounts for which the State is applying
p.000903: pursuant to such section;
p.000903: (2) such description identifies the geographic areas within the State in which the greatest numbers of
p.000903: homeless individ- uals with a need for mental health, substance use disorder, and housing services are
p.000903: located;
p.000903: (3) such description provides information relating to the programs and activities to be supported and services
p.000903: to be pro- vided, including information relating to coordinating such pro- grams and activities with any similar
p.000903: programs and activities of public and private entities; and
p.000903: (4) the State agrees that such description will be revised throughout the year as may be necessary to reflect
p.000903: substantial changes in the programs and activities assisted by the State pursuant to section 522.
p.000903: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 521 unless the
p.000903: State involved agrees that, in developing and carrying out the description required in subsection (a), the State
p.000903: will provide public notice with respect to the description (including any revisions) and such
p.000903: opportunities as may be necessary to provide interested persons, such as family members, consumers, and
p.000903: mental health, substance use disorder, and housing agencies, an opportunity to present comments and rec-
p.000903: ommendations with respect to the description.
p.000903: (c) RELATIONSHIP TO STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLAN.—
p.000903: (1) IN GENERAL.—The Secretary may not make payments under section 521 unless the services to be provided
p.000903: pursuant to the description required in subsection (a) are consistent with the State comprehensive mental health
p.000903: services plan required in subpart 2 of part B of title XIX.
p.000903: (2) SPECIAL RULE.—The Secretary may not make payments under section 521 unless the services to be provided
p.000903: pursuant to the description required in subsection (a) have been consid- ered in the preparation of, have been included
p.000903: in, and are con-
p.000903: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000905: PUBLIC HEALTH SERVICE ACT
p.000905: Sec. 531
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p.000905: sistent with, the State comprehensive mental health services plan referred to in paragraph (1).
p.000905: SEC. 528. ø290cc–28¿ REQUIREMENT OF REPORTS BY STATES.
p.000905: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000905: agrees that, by not later than January 31 of each fiscal year, the State will prepare and submit to
p.000905: the Secretary a report in such form and containing such information as the Secretary determines (after
p.000905: consultation with the Assistant Secretary for Mental Health and Substance Use) to be necessary for—
p.000905: (1) securing a record and a description of the purposes for which amounts received under section 521 were expended dur-
p.000905: ing the preceding fiscal year and of the recipients of such amounts; and
p.000905: (2) determining whether such amounts were expended in accordance with the provisions of this part.
p.000905: (b) AVAILABILITY TO PUBLIC OF REPORTS.—The Secretary may not make payments under section 521 unless the
p.000905: State involved agrees to make copies of the reports described in subsection (a) available for public
p.000905: inspection.
p.000905: (c) EVALUATIONS BY COMPTROLLER GENERAL.—The Assistant Secretary for Mental Health and Substance Use
p.000905: shall evaluate at least once every 3 years the expenditures of grants under this part by eligible entities in
p.000905: order to ensure that expenditures are con- sistent with the provisions of this part, and shall include
p.000905: in such evaluation recommendations regarding changes needed in program design or operations.
p.000905: SEC. 529. ø290cc–29¿ REQUIREMENT OF APPLICATION.
p.000905: The Secretary may not make payments under section 521 un- less the State involved—
p.000905: (1) submits to the Secretary an application for the pay- ments containing agreements and information in
p.000905: accordance with this part;
p.000905: (2) the agreements are made through certification from the chief executive officer of the State; and
p.000905: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.000905: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.000905: SEC. 530. ø290cc–30¿ TECHNICAL ASSISTANCE.
p.000905: The Secretary, acting through the Assistant Secretary, shall provide technical assistance to eligible
p.000905: entities in developing plan- ning and operating programs in accordance with the provisions of this part.
p.000905: SEC. 531. ø290cc–31¿ FAILURE TO COMPLY WITH AGREEMENTS.
p.000905: (a) REPAYMENT OF PAYMENTS.—
p.000905: (1) The Secretary may, subject to subsection (c), require a State to repay any payments received by the
p.000905: State under sec- tion 521 that the Secretary determines were not expended by the State in accordance
p.000905: with the agreements required to be contained in the application submitted by the State pursuant to section
...

p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000907: Sec. 535 PUBLIC HEALTH SERVICE ACT 908
p.000907:
p.000907: (2) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ has the meaning given such term in
p.000907: section 330(h)(5).
p.000907: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000907: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.000907: (4) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘sub- stance use disorder services’’ has the meaning
p.000907: given the term ‘‘substance abuse services’’ in section 330(h)(5)(C).
p.000907: SEC. 535. ø290cc–35¿ FUNDING.
p.000907: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there is authorized to
p.000907: be appropriated
p.000907: $64,635,000 for each of fiscal years 2018 through 2022.
p.000907: (b) EFFECT OF INSUFFICIENT APPROPRIATIONS FOR MINIMUM ALLOTMENTS.—
p.000907: (1) IN GENERAL.—If the amounts made available under subsection (a) for a fiscal year are insufficient
p.000907: for providing each State with an allotment under section 521 of not less than the applicable amount under section
p.000907: 524(a)(1), the Secretary shall, from such amounts as are made available under such subsection, make grants
p.000907: to the States for providing to eligible homeless individuals the services specified in section 522(b).
p.000907: (2) RULE OF CONSTRUCTION.—Paragraph (1) may not be construed to require the Secretary to make a grant under such
p.000907: paragraph to each State.
p.000907: PART D—MISCELLANEOUS PROVISIONS RELATING TO SUBSTANCE ABUSE AND MENTAL HEALTH
p.000907: SEC. 541. ø290dd¿ SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
p.000907: (a) PROGRAMS AND SERVICES.—
p.000907: (1) DEVELOPMENT.—The Secretary, acting through the As- sistant Secretary for Mental Health and Substance
p.000907: Use, shall be responsible for fostering substance abuse prevention and treatment programs and services in
p.000907: State and local govern- ments and in private industry.
p.000907: (2) MODEL PROGRAMS.—
p.000907: (A) IN GENERAL.—Consistent with the responsibilities described in paragraph (1), the Secretary, acting
p.000907: through the Assistant Secretary for Mental Health and Substance Use, shall develop a variety of model programs
p.000907: suitable for replication on a cost-effective basis in different types of business concerns and State and
p.000907: local governmental enti- ties.
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p.000907: January 30, 2020
p.000907: (B) DISSEMINATION OF INFORMATION.—The Secretary, acting through the Assistant Secretary for Mental Health
p.000907: and Substance Use, shall disseminate information and ma- terials relative to such model programs to the State agen-
p.000907: cies responsible for the administration of substance abuse prevention, treatment, and rehabilitation
p.000907: activities and shall, to the extent feasible provide technical assistance to such agencies as requested.
p.000907: (b) DEPRIVATION OF EMPLOYMENT.—
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000909: PUBLIC HEALTH SERVICE ACT
p.000909: Sec. 542
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p.000909: (1) PROHIBITION.—No person may be denied or deprived of Federal civilian employment or a Federal professional or other
p.000909: license or right solely on the grounds of prior substance abuse.
p.000909: (2) APPLICATION.—This subsection shall not apply to em- ployment in—
p.000909: (A) the Central Intelligence Agency;
p.000909: (B) the Federal Bureau of Investigation;
p.000909: (C) the National Security Agency;
p.000909: (D) any other department or agency of the Federal Government designated for purposes of national security
p.000909: by the President; or
p.000909: (E) in any position in any department or agency of the Federal Government, not referred to in subparagraphs (A) through
p.000909: (D), which position is determined pursuant to reg- ulations prescribed by the head of such agency or depart-
p.000909: ment to be a sensitive position.
p.000909: (3) REHABILITATION ACT.—The inapplicability of the prohi- bition described in paragraph (1) to the employment described
p.000909: in paragraph (2) shall not be construed to reflect on the appli- cability of the Rehabilitation Act of 1973 or other
p.000909: anti-discrimi- nation laws to such employment.
p.000909: (c) CONSTRUCTION.—This section shall not be construed to pro- hibit the dismissal from employment of a Federal civilian
p.000909: employee who cannot properly function in his employment.
p.000909: SEC. 542. ø290dd–1¿ ADMISSION OF SUBSTANCE ABUSERS TO PRIVATE AND PUBLIC HOSPITALS AND OUTPATIENT FACILITIES.
p.000909: (a) NONDISCRIMINATION.—Substance abusers who are suffering from medical conditions shall not be discriminated
p.000909: against in ad- mission or treatment, solely because of their substance abuse, by any private or public
p.000909: general hospital, or outpatient facility (as de- fined in section 1624(4)) which receives support in any form
p.000909: from any program supported in whole or in part by funds appropriated to any Federal department or agency.
p.000909: (b) REGULATIONS.—
p.000909: (1) IN GENERAL.—The Secretary shall issue regulations for the enforcement of the policy of subsection (a) with
p.000909: respect to the admission and treatment of substance abusers in hospitals and outpatient facilities which receive
p.000909: support of any kind from any program administered by the Secretary. Such regula- tions shall include procedures
p.000909: for determining (after oppor- tunity for a hearing if requested) if a violation of subsection (a) has occurred,
p.000909: notification of failure to comply with such sub- section, and opportunity for a violator to comply with such
p.000909: sub- section. If the Secretary determines that a hospital or out- patient facility subject to such
p.000909: regulations has violated sub- section (a) and such violation continues after an opportunity has been
p.000909: afforded for compliance, the Secretary may suspend or revoke, after opportunity for a hearing, all or
p.000909: part of any support of any kind received by such hospital from any pro- gram administered by the
p.000909: Secretary. The Secretary may con- sult with the officials responsible for the administration of any other Federal
p.000909: program from which such hospital or outpatient facility receives support of any kind, with respect to the
p.000909: sus-
p.000909: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000909: Sec. 543 PUBLIC HEALTH SERVICE ACT 910
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p.000909: January 30, 2020
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p.000909: pension or revocation of such other Federal support for such hospital or outpatient facility.
p.000909: (2) DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Under
p.000909: Secretary for Health, shall, to the maximum feasible extent consistent with their responsibilities under
p.000909: title 38, United States Code, pre- scribe regulations making applicable the regulations prescribed by the
p.000909: Secretary under paragraph (1) to the provision of hos- pital care, nursing home care, domiciliary care,
p.000909: and medical services under such title 38 to veterans suffering from sub- stance abuse. In prescribing
p.000909: and implementing regulations pursuant to this paragraph, the Secretary shall, from time to time, consult
p.000909: with the Secretary of Health and Human Serv- ices in order to achieve the maximum possible coordination
p.000909: of the regulations, and the implementation thereof, which they each prescribe.
p.000909: SEC. 543. ø290dd–2¿ CONFIDENTIALITY OF RECORDS.
p.000909: (a) REQUIREMENT.—Records of the identity, diagnosis, prog- nosis, or treatment of any patient which are
p.000909: maintained in connec- tion with the performance of any program or activity relating to substance abuse
p.000909: education, prevention, training, treatment, reha- bilitation, or research, which is conducted, regulated, or
p.000909: directly or indirectly assisted by any department or agency of the United States shall, except as provided
p.000909: in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly
p.000909: authorized under subsection (b).
p.000909: (b) PERMITTED DISCLOSURE.—
p.000909: (1) CONSENT.—The content of any record referred to in subsection (a) may be disclosed in accordance with
p.000909: the prior written consent of the patient with respect to whom such record is maintained, but only to
p.000909: such extent, under such cir- cumstances, and for such purposes as may be allowed under regulations
p.000909: prescribed pursuant to subsection (g).
p.000909: (2) METHOD FOR DISCLOSURE.—Whether or not the patient, with respect to whom any given record referred to in
p.000909: sub- section (a) is maintained, gives written consent, the content of such record may be disclosed as follows:
p.000909: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
p.000909: (B) To qualified personnel for the purpose of con- ducting scientific research, management audits,
p.000909: financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any
...

p.000911: under State law of incidents of suspected child abuse and neglect to the appropriate State or local
p.000911: authorities.
p.000911: (f) PENALTIES.—Any person who violates any provision of this section or any regulation issued pursuant to
p.000911: this section shall be fined in accordance with title 18, United States Code.
p.000911: (g) REGULATIONS.—Except as provided in subsection (h), the Secretary shall prescribe regulations to carry
p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
p.000911: to this subsection, the Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of
p.000911: Health and Human Services in order to achieve the maximum possible coordination of the regu- lations, and the
p.000911: implementation thereof, which they each prescribe.
p.000911: SEC. 543A. ø290dd–2a¿ PROMOTING ACCESS TO INFORMATION ON EVI- DENCE-BASED PROGRAMS AND PRACTICES.
p.000911: (a) IN GENERAL.—The Assistant Secretary shall, as appro- priate, improve access to reliable and valid
p.000911: information on evi- dence-based programs and practices, including information on the strength of evidence
p.000911: associated with such programs and practices, related to mental and substance use disorders for States, local com-
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: Sec. 544 PUBLIC HEALTH SERVICE ACT 912
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p.000911: January 30, 2020
p.000911:
p.000911: munities, nonprofit entities, and other stakeholders, by posting on the Internet website of the Administration
p.000911: information on evidence- based programs and practices that have been reviewed by the As- sistant Secretary
p.000911: in accordance with the requirements of this sec- tion.
p.000911: (b) APPLICATIONS.—
p.000911: (1) APPLICATION PERIOD.—In carrying out subsection (a), the Assistant Secretary may establish a period for the
p.000911: submis- sion of applications for evidence-based programs and practices to be posted publicly in accordance with
p.000911: subsection (a).
p.000911: (2) NOTICE.—In establishing the application period under paragraph (1), the Assistant Secretary shall
p.000911: provide for the public notice of such application period in the Federal Register. Such notice may solicit
p.000911: applications for evidence-based pro- grams and practices to address gaps in information identified by the
p.000911: Assistant Secretary, the National Mental Health and Substance Use Policy Laboratory established under
p.000911: section 501A, or the Assistant Secretary for Planning and Evaluation, including pursuant to the evaluation and
p.000911: recommendations under section 6021 of the Helping Families in Mental Health Crisis Reform Act of 2016 or
p.000911: priorities identified in the stra- tegic plan under section 501(l).
p.000911: (c) REQUIREMENTS.—The Assistant Secretary may establish minimum requirements for the applications
p.000911: submitted under sub- section (b), including applications related to the submission of re- search and
p.000911: evaluation.
p.000911: (d) REVIEW AND RATING.—
p.000911: (1) IN GENERAL.—The Assistant Secretary shall review ap- plications prior to public posting in accordance with
p.000911: subsection (a), and may prioritize the review of applications for evidence- based programs and practices that are
p.000911: related to topics in- cluded in the notice provided under subsection (b)(2).
p.000911: (2) SYSTEM.—In carrying out paragraph (1), the Assistant Secretary may utilize a rating and review
p.000911: system, which may include information on the strength of evidence associated with the evidence-based programs and
p.000911: practices and a rating of the methodological rigor of the research supporting the applica- tions.
p.000911: (3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant Secretary shall make the metrics used to evaluate
p.000911: applications under this section, and any resulting ratings of such applica- tions, publicly available.
p.000911: SEC. 544. ø290dd–3¿ GRANTS FOR REDUCING OVERDOSE DEATHS.
p.000911: (a) ESTABLISHMENT.—
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p.000913: (c) PREFERENCE IN MAKING GRANTS.—In making grants under this section, the Secretary may give preference to States
p.000913: that have a significantly higher rate of opioid overdoses than the national av- erage, and that—
p.000913: (1) have not implemented standing orders regarding drugs or devices approved or cleared under the Federal Food,
p.000913: Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose;
p.000913: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: 915
p.000915: PUBLIC HEALTH SERVICE ACT
p.000915: Sec. 546
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p.000915: (2) authorize standing orders to be issued that permit com- munity-based organizations, substance abuse
p.000915: programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved or
p.000915: cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000915: opioid overdose; or
p.000915: (3) authorize standing orders to be issued that permit po- lice, fire, or emergency medical services
p.000915: agencies to acquire and administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose.
p.000915: (d) GRANT TERMS.—
p.000915: (1) NUMBER.—A State may not receive more than one grant under this section at a time.
p.000915: (2) PERIOD.—A grant under this section shall be for a pe- riod of 3 years.
p.000915: (3) LIMITATION.—A State may use not more than 20 per- cent of a grant under this section for educating the
p.000915: public pur- suant to subsection (a)(4).
p.000915: (e) APPLICATIONS.—To be eligible to receive a grant under this section, a State shall submit an application to
p.000915: the Secretary in such form and manner and containing such information as the Sec- retary may reasonably require,
p.000915: including detailed proposed expend- itures of grant funds.
p.000915: (f) REPORTING.—A State that receives a grant under this sec- tion shall, at least annually for the
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p.000915: metic Act for emergency treatment of known or suspected opioid overdose.
p.000915: (b) APPLICATION.—
p.000915: (1) IN GENERAL.—An entity seeking a grant under this sec- tion shall submit an application to the Secretary—
p.000915: (A) that meets the criteria under paragraph (2); and
p.000915: (B) at such time, in such manner, and accompanied by such information as the Secretary may require.
p.000915: (2) CRITERIA.—An entity, in submitting an application under paragraph (1), shall—
p.000915: (A) describe the evidence-based methodology and out- come measurements that will be used to evaluate the pro-
p.000915: gram funded with a grant under this section, and specifi- cally explain how such measurements will
p.000915: provide valid measures of the impact of the program;
p.000915: (B) describe how the program could be broadly rep- licated if demonstrated to be effective;
p.000915: (C) identify the governmental and community agencies with which the entity will coordinate to implement the
p.000915: program; and
p.000915: (D) describe how the entity will ensure that law en- forcement agencies will coordinate with
p.000915: their cor- responding State substance abuse and mental health agen- cies to identify protocols and resources
p.000915: that are available to overdose victims and families, including information on treatment and recovery
p.000915: resources.
p.000915: (c) USE OF FUNDS.—An entity shall use a grant received under this section to—
p.000915: (1) make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000915: treatment of known or suspected opioid overdose available to be carried and administered by first
p.000915: responders and members of other key community sectors;
p.000915: (2) train and provide resources for first responders and members of other key community sectors on
p.000915: carrying and ad- ministering a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose;
p.000915: (3) establish processes, protocols, and mechanisms for re- ferral to appropriate treatment, which may
p.000915: include an out- reach coordinator or team to connect individuals receiving opioid overdose reversal
p.000915: drugs to followup services; and
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p.000917: (1) the number of first responders and members of other key community sectors equipped with a drug or
p.000917: device ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000917: suspected opioid overdose;
p.000917: (2) the number of opioid and heroin overdoses reversed by first responders and members of other key community
p.000917: sectors receiving training and supplies of a drug or device approved or cleared under the Federal Food, Drug, and
p.000917: Cosmetic Act for emergency treatment of known or suspected opioid overdose, through a grant received under
p.000917: this section;
p.000917: (3) the number of responses to requests for services by the entity or subgrantee, to opioid and heroin overdose;
p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
p.000917: organization that—
p.000917: (1) mobilizes resources within and outside of the recovery community, which may include through a peer
p.000917: support net- work, to increase the prevalence and quality of long-term re- covery from substance use
p.000917: disorders; and
p.000917: (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community
p.000917: served.
p.000917: (b) GRANTS AUTHORIZED.—The Secretary shall award grants to recovery community organizations to enable such
p.000917: organizations to develop, expand, and enhance recovery services.
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000917: Sec. 547A PUBLIC HEALTH SERVICE ACT 918
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p.000917: (c) FEDERAL SHARE.—The Federal share of the costs of a pro- gram funded by a grant under this section may not
p.000917: exceed 85 per- cent.
p.000917: (d) USE OF FUNDS.—Grants awarded under subsection (b)—
p.000917: (1) shall be used to develop, expand, and enhance commu- nity and statewide recovery support services; and
p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
p.000917: each of fis- cal years 2019 through 2023.
p.000917: SEC. 547A. ø290ee–2a¿ PEER SUPPORT TECHNICAL ASSISTANCE CEN- TER.
p.000917: (a) ESTABLISHMENT.—The Secretary, acting through the Assist- ant Secretary, shall establish or operate a
p.000917: National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this
p.000917: section as the ‘‘Center’’).
p.000917: (b) FUNCTIONS.—The Center established under subsection (a) shall provide technical assistance and support
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p.000919: with a substance use disorder; and
p.000919: (C) best practices for the delivery of recovery support services;
p.000919: (2) the provision of translation services, interpretation, or other such services for clients with limited
p.000919: English speaking proficiency;
p.000919: (3) data collection to support research, including for translational research;
p.000919: (4) capacity building; and
p.000919: (5) evaluation and improvement, as necessary, of the effec- tiveness of such services provided by recovery community
p.000919: orga- nizations.
p.000919: (c) BEST PRACTICES.—The Center established under subsection
p.000919: (a) shall periodically issue best practices for use by recovery com- munity organizations and peer support
p.000919: networks.
p.000919: (d) RECOVERY COMMUNITY ORGANIZATION.—In this section, the term ‘‘recovery community organization’’ has the
p.000919: meaning given such term in section 547.
p.000919: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000919: $1,000,000 for each of fiscal years 2019 through 2023.
p.000919: SEC. 548. ø290ee–3¿ STATE DEMONSTRATION GRANTS FOR COM- PREHENSIVE OPIOID ABUSE RESPONSE.
p.000919: (a) DEFINITIONS.—In this section:
p.000919: (1) DISPENSER.—The term ‘‘dispenser’’ has the meaning given the term in section 102 of the Controlled Substances
p.000919: Act (21 U.S.C. 802).
p.000919: (2) PRESCRIBER.—The term ‘‘prescriber’’ means a dispenser who prescribes a controlled substance, or the agent
p.000919: of such a dispenser.
p.000919: (3) PRESCRIBER OF A SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘prescriber of a schedule
p.000919: II, III, or IV controlled substance’’ does not include a prescriber of a sched- ule II, III, or IV controlled
p.000919: substance that dispenses the sub- stance—
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p.000919: (A) for use on the premises on which the substance is dispensed;
p.000919: (B) in a hospital emergency room, when the substance is in short supply;
p.000919: (C) for a certified opioid treatment program; or
p.000919: (D) in other situations as the Secretary may reason- ably determine.
p.000919: (4) SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘schedule II, III, or IV controlled substance’’
p.000919: means a con- trolled substance that is listed on schedule II, schedule III, or schedule IV of section 202(c)
p.000919: of the Controlled Substances Act.
p.000919: (b) GRANTS FOR COMPREHENSIVE OPIOID ABUSE RESPONSE.—
p.000919: (1) IN GENERAL.—The Secretary shall award grants to States, and combinations of States, to implement an
p.000919: integrated opioid abuse response initiative.
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: (2) PURPOSES.—A State receiving a grant under this sec- tion shall establish a comprehensive response
p.000919: plan to opioid abuse, which may include—
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p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
p.000923: for the pe- riod of fiscal years 2018 through 2022.
p.000923: SEC. 550. 15 ø290ee–5¿ NATIONAL RECOVERY HOUSING BEST PRAC- TICES.
p.000923: (a) BEST PRACTICES FOR OPERATING RECOVERY HOUSING.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities specified in paragraph
p.000923: (2), shall iden- tify or facilitate the development of best practices, which may include model laws
p.000923: for implementing suggested minimum standards, for operating recovery housing.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate—
p.000923: (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Men- tal
p.000923: Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for
p.000923: Medicare & Medicaid Services;
p.000923: (B) the Secretary of Housing and Urban Development;
p.000923: (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State
p.000923: Med- icaid programs, and State insurance agencies;
p.000923: (D) representatives of health insurance issuers;
p.000923: (E) national accrediting entities and reputable pro- viders of, and analysts of, recovery housing
p.000923: services, in- cluding Indian tribes, tribal organizations, and tribally
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p.000923: 15 A second section 550 (relating to Sobriety Treatment and Recovery Teams) appears at the end of title V
p.000923: as added by section 8214 of Public Law 115–271.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000923: designated housing entities that provide recovery housing services, as applicable;
p.000923: (F) individuals with a history of substance use dis- order; and
p.000923: (G) other stakeholders identified by the Secretary.
p.000923: (b) IDENTIFICATION OF FRAUDULENT RECOVERY HOUSING OPER-
p.000923: ATORS.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities described in paragraph (2),
p.000923: shall iden- tify or facilitate the development of common indicators that could be used to identify potentially
p.000923: fraudulent recovery hous- ing operators.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate, the individuals and entities specified in subsection (a)(2) and the Attorney General of
p.000923: the United States.
p.000923: (3) REQUIREMENTS.—
p.000923: (A) PRACTICES FOR IDENTIFICATION AND REPORTING.— In carrying out the activities described in paragraph
p.000923: (1), the Secretary shall consider how law enforcement, public and private payers, and the public can best
p.000923: identify and report fraudulent recovery housing operators.
p.000923: (B) FACTORS TO BE CONSIDERED.—In carrying out the activities described in paragraph (1), the Secretary
p.000923: shall identify or develop indicators, which may include indica- tors related to—
p.000923: (i) unusual billing practices;
p.000923: (ii) average lengths of stays;
p.000923: (iii) excessive levels of drug testing (in terms of cost or frequency); and
p.000923: (iv) unusually high levels of recidivism.
p.000923: (c) DISSEMINATION.—The Secretary shall, as appropriate, dis- seminate the best practices identified or
p.000923: developed under sub- section (a) and the common indicators identified or developed under subsection (b) to—
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p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
p.000925: Disorder Education for purposes of im- proving health professional training resources with respect to sub- stance
p.000925: use disorder prevention, treatment, and recovery.
p.000925: (b) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under subsection (a), an entity shall—
p.000925: (1) be an accredited entity that offers education to students in various health professions, which may include—
p.000925: (A) a teaching hospital;
p.000925: (B) a medical school;
p.000925: (C) a certified behavioral health clinic; or
p.000925: (D) any other health professions school, school of pub- lic health, or Cooperative Extension Program at institu-
p.000925: tions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in
p.000925: the prevention, treatment, or recovery of substance use disorders;
p.000925: (2) demonstrate community engagement and partnerships with community stakeholders, including entities
p.000925: that train health professionals, mental health counselors, social workers, peer recovery specialists,
p.000925: substance use treatment programs, community health centers, physician offices, certified behav- ioral health
p.000925: clinics, research institutions, and law enforcement; and
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p.000925: (3) submit to the Secretary an application containing such information, at such time, and in such manner, as
p.000925: the Sec- retary may require.
p.000925: (c) ACTIVITIES.—An entity receiving an award under this sec- tion shall develop, evaluate, and
p.000925: distribute evidence-based re- sources regarding the prevention and treatment of, and recovery from,
p.000925: substance use disorders. Such resources may include informa- tion on—
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: Sec. 552 PUBLIC HEALTH SERVICE ACT 926
p.000925:
p.000925: (1) the neurology and pathology of substance use disorders;
p.000925: (2) advancements in the treatment of substance use dis- orders;
p.000925: (3) techniques and best practices to support recovery from substance use disorders;
p.000925: (4) strategies for the prevention and treatment of, and re- covery from substance use disorders across patient
p.000925: populations; and
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p.000925: (5) other topic areas that are relevant to the objectives de- scribed in subsection (a).
p.000925: (d) GEOGRAPHIC DISTRIBUTION.—In awarding cooperative agreements under subsection (a), the Secretary
p.000925: shall take into ac- count regional differences among eligible entities and shall make an effort to ensure
p.000925: geographic distribution.
p.000925: (e) EVALUATION.—The Secretary shall evaluate each project carried out by an entity receiving an award under this
p.000925: section and shall disseminate the findings with respect to each such evaluation to appropriate public and private
p.000925: entities.
p.000925: (f) FUNDING.—There is authorized to be appropriated to carry out this section, $4,000,000 for each of
p.000925: fiscal years 2019 through 2023.
p.000925: SEC. 552. ø290ee–7¿ COMPREHENSIVE OPIOID RECOVERY CENTERS.
p.000925: (a) IN GENERAL.—The Secretary shall award grants on a com- petitive basis to eligible entities to establish or
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p.000927: utilizing tech- nology-enabled collaborative learning and capacity building models, including such models as defined
p.000927: in section 2 of the Expanding Ca- pacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to
p.000927: conduct the activities described in this section.
p.000927: (g) CENTER ACTIVITIES.—Each Center shall, at a minimum, carry out the following activities directly,
p.000927: through referral, or through contractual arrangements, which may include carrying out such activities through
p.000927: technology-enabled collaborative learning and capacity building models described in subsection (f):
p.000927: (1) TREATMENT AND RECOVERY SERVICES.—Each Center shall—
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p.000927: (A) Ensure that intake, evaluations, and periodic pa- tient assessments meet the individualized clinical needs
p.000927: of patients, including by reviewing patient placement in treatment settings to support meaningful recovery.
p.000927: (B) Provide the full continuum of treatment services, including—
p.000927: (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all bio- logical
p.000927: products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant
p.000927: to Federal and State law;
p.000927: (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and
p.000927: readiness for and entry into treatment;
p.000927: (iii) counseling provided by a program counselor or other certified professional who is licensed and quali- fied
p.000927: by education, training, or experience to assess the psychological and sociological background of patients, to
p.000927: contribute to the appropriate treatment plan for the patient, and to monitor patient progress;
p.000927: (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders;
p.000927: (v) testing, as appropriate, for infections com- monly associated with illicit drug use;
p.000927: (vi) residential rehabilitation, and outpatient and intensive outpatient programs;
p.000927: (vii) recovery housing;
p.000927: (viii) community-based and peer recovery support services;
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
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p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
p.000927: (h) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant awarded under subsection (a), not later
p.000927: than 90 days after the end of the first year of the grant period, and annually thereafter for the
p.000927: duration of the grant period (including the dura- tion of any renewal period for such grant), the entity shall submit
p.000927: data, as appropriate, to the Secretary regarding—
p.000927: (1) the programs and activities funded by the grant;
p.000927: (2) health outcomes of the population of individuals with a substance use disorder who received services
p.000927: from the Cen-
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000929: 929
p.000929: PUBLIC HEALTH SERVICE ACT
p.000929: Sec. 561
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p.000929: ter, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the
p.000929: Secretary;
p.000929: (3) the retention rate of program participants; and
p.000929: (4) any other information that the Secretary may require for the purpose of—ensuring that the Center is
p.000929: complying with all the requirements of the grant, including providing the full continuum of services described
p.000929: in subsection (g)(1)(B).
p.000929: (i) PRIVACY.—The provisions of this section, including with re- spect to data reporting and program
p.000929: oversight, shall be subject to all applicable Federal and State privacy laws.
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p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
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p.000937: January 30, 2020
p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
p.000939: SEC. 581. 19 ø290hh¿ CHILDREN AND VIOLENCE.
p.000939: (a) IN GENERAL.—The Secretary, in consultation with the Sec- retary of Education and the Attorney General, shall
p.000939: carry out di- rectly or through grants, contracts or cooperative agreements with public entities a program to assist
p.000939: local communities in developing ways to assist children in dealing with violence.
p.000939: (b) ACTIVITIES.—Under the program under subsection (a), the Secretary may—
p.000939: (1) provide financial support to enable local communities to implement programs to foster the health and
p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
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p.000945: ing medical assistance, legal issues, position asphyxia, escape and evasion techniques, time limits for the use
p.000945: of restraint and
p.000945: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000947: 947
p.000947: PUBLIC HEALTH SERVICE ACT
p.000947: Sec. 581
p.000947:
p.000947: seclusion, the process for obtaining approval for continued re- straints and seclusion, procedures to
p.000947: address problematic re- straints, documentation, processing with children, and follow- up with staff, and
p.000947: investigation of injuries and complaints; and
p.000947: (3) that such facilities provide complete and accurate noti- fication of deaths, as required under section 595A(1).
p.000947: (c) ENFORCEMENT.—A State to which this part applies that fails to comply with any requirement of this part,
p.000947: including a fail- ure to provide appropriate training and certification, shall not be eligible for
p.000947: participation in any program supported in whole or in part by funds appropriated under this Act.
p.000947: PART G 22—SERVICES PROVIDED THROUGH RELIGIOUS ORGANIZATIONS 23
p.000947: SEC. 581. ø290kk¿ APPLICABILITY TO DESIGNATED PROGRAMS.
p.000947: (a) DESIGNATED PROGRAMS.—Subject to subsection (b), this part applies to discretionary and formula grant
p.000947: programs adminis- tered by the Substance Abuse and Mental Health Services Admin- istration that make awards of
p.000947: financial assistance to public or pri- vate entities for the purpose of carrying out activities to prevent or treat
p.000947: substance abuse (in this part referred to as a ‘‘designated pro- gram’’). Designated programs include the program under
p.000947: subpart II of part B of title XIX (relating to formula grants to the States).
p.000947: (b) LIMITATION.—This part does not apply to any award of fi- nancial assistance under a designated program
p.000947: for a purpose other than the purpose specified in subsection (a).
p.000947: (c) DEFINITIONS.—For purposes of this part (and subject to sub- section (b)):
p.000947: (1) The term ‘‘designated program’’ has the meaning given such term in subsection (a).
p.000947: (2) The term ‘‘financial assistance’’ means a grant, coopera- tive agreement, or contract.
p.000947: (3) The term ‘‘program beneficiary’’ means an individual who receives program services.
p.000947: (4) The term ‘‘program participant’’ means a public or pri- vate entity that has received financial assistance under a
p.000947: des- ignated program.
p.000947: (5) The term ‘‘program services’’ means treatment for sub- stance abuse, or preventive services regarding such abuse,
p.000947: pro- vided pursuant to an award of financial assistance under a designated program.
p.000947: (6) The term ‘‘religious organization’’ means a nonprofit re- ligious organization.
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p.000947: January 30, 2020
p.000947: 22 There are two parts G in this title. The first was added by section 3101 of Public Law 106– 310 (114 Stat. 1168) and
p.000947: relates to projects for children and violence; that part also begins with section 581. See page 669. Sections
p.000947: 3207 and 3208 of such Public Law (114 Stat. 1195, 1197) added parts H and I, respectively.
p.000947: Subsequently, part G above was added by section 144 of the Community Renewal Tax Relief Act of 2000 (as enacted
p.000947: into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A– 619), which provides that title V
p.000947: of this Act ‘‘is amended by adding at the end the following part:’’, thereby placing that part G after the
p.000947: part I added by Public Law 106–310.
p.000947: 23 Section 1955 of this Act also relates to religious organizations as providers of substance abuse
p.000947: services. That section was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.000947: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000947:
p.000947: SEC. 582. ø290kk–1¿ RELIGIOUS ORGANIZATIONS AS PROGRAM PAR- TICIPANTS.
p.000947: (a) IN GENERAL.—Notwithstanding any other provision of law, a religious organization, on the same basis
p.000947: as any other nonprofit private provider—
p.000947: (1) may receive financial assistance under a designated program; and
p.000947: (2) may be a provider of services under a designated pro- gram.
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p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
p.000951: National Center on Substance Abuse and Child Welfare.
p.000951: TITLE VI—ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000951: DECLARATION OF PURPOSE
p.000951: SEC. 600. ø291¿ The purpose of this title is—
p.000951: (a) to assist the several States in the carrying out of their programs for the construction and modernization of such
p.000951: public or other nonprofit community hospitals and other medical fa- cilities as may be necessary, in
p.000951: conjunction with existing facili-
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p.000951: January 30, 2020
p.000951: 24 Placement of section 550 is so in law. Section 8214 of Public Law 115-271 inserted a second section 550 at the end
p.000951: of title V.
p.000951: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951:
p.000951: ties, to furnish adequate hospital, clinic, or similar services to all their people;
p.000951: (b) to stimulate the development of new or improved types of physical facilities for medical, diagnostic,
p.000951: preventive, treat- ment, or rehabilitative services; and
p.000951: (c) to promote research, experiments, and demonstrations relating to the effective development and utilization of
p.000951: hospital, clinic, or similar services, facilities, and resources, and to pro- mote the coordination of such
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p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
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p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
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p.001045: other sti- pends as the Secretary may consider necessary; and
p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: 1047
p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
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p.001051: ment), and safe disposal options for prescription medications (including such options provided by law
p.001051: enforcement or other innovative deactivation mechanisms).
p.001051: (c) EVALUATION OF PROGRAMS.—The Secretary shall (directly or through grants or contracts) provide for
p.001051: the evaluation of pro- grams implemented under subsection (a) in order to determine the effect of such programs on
p.001051: knowledge and practice of pain care.
p.001051: (d) PAIN CARE DEFINED.—For purposes of this section the term ‘‘pain care’’ means the assessment, diagnosis,
p.001051: prevention, treat- ment, or management of acute or chronic pain regardless of causa- tion or body location.
p.001051: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001051: such sums as may be necessary for each of the fiscal years 2019 through 2023. Amounts appropriated under this
p.001051: subsection shall remain available until ex- pended.
p.001051: SEC. 760. ø294k¿ TRAINING DEMONSTRATION PROGRAM.
p.001051: (a) IN GENERAL.—The Secretary shall establish a training dem- onstration program to award grants to eligible entities
p.001051: to support—
p.001051: (1) training for medical residents and fellows to practice psychiatry and addiction medicine in underserved,
p.001051: community- based settings that integrate primary care with mental and substance use disorders prevention and
p.001051: treatment services;
p.001051: (2) training for nurse practitioners, physician assistants, health service psychologists, and social workers
p.001051: to provide mental and substance use disorders services in underserved community-based settings that
p.001051: integrate primary care and mental and substance use disorders services; and
p.001051: (3) establishing, maintaining, or improving academic units or programs that—
p.001051: (A) provide training for students or faculty, including through clinical experiences and research, to
p.001051: improve the ability to be able to recognize, diagnose, and treat mental and substance use disorders, with a
p.001051: special focus on addic- tion; or
p.001051: (B) develop evidence-based practices or recommenda- tions for the design of the units or programs
p.001051: described in subparagraph (A), including curriculum content standards.
p.001051: (b) ACTIVITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—A recipient of a grant under subsection (a)(1)—
p.001051: (A) shall use the grant funds—
p.001051: (i)(I) to plan, develop, and operate a training pro- gram for medical psychiatry residents and fellows
p.001051: in addiction medicine practicing in eligible entities de- scribed in subsection (c)(1); or
p.001051: (II) to train new psychiatric residents and fellows in addiction medicine to provide and expand access to
p.001051: integrated mental and substance use disorders serv- ices; and
p.001051: (ii) to provide at least 1 training track that is—
p.001051: (I) a virtual training track that includes an in-person rotation at a teaching health center or
p.001051: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: tinues to support the care of patients at the teach- ing health center or in the community-based set- ting
p.001051: through the use of health information tech- nology and, as appropriate, telehealth services;
p.001051: (II) an in-person training track that includes a rotation, during which the resident or fellow practices
p.001051: at a teaching health center or in a com- munity-based setting; or
p.001051: (III) an in-person training track that includes a rotation during which the resident practices in a
p.001051: community-based setting that specializes in the treatment of infants, children, adolescents, or pregnant
p.001051: or postpartum women; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such training.
p.001051: (2) TRAINING FOR OTHER PROVIDERS.—A recipient of a grant under subsection (a)(2)—
p.001051: (A) shall use the grant funds to plan, develop, or oper- ate a training program to provide mental and substance
p.001051: use disorders services in underserved, community-based settings, as appropriate, that integrate primary care
p.001051: and mental and substance use disorders prevention and treat- ment services; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
p.001051: College Accreditation, the Accreditation Commission for Education in Nursing, the Commission on Col- legiate Nursing
p.001051: Education, the Accreditation Council for Phar- macy Education, the Council on Social Work Education, Amer- ican
p.001051: Psychological Association Commission on Accreditation, or the Accreditation Review Commission on Education for
p.001051: the Physician Assistant) to carry out activities under subsection (a)(3).
p.001051: (c) ELIGIBLE ENTITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—To be eligible to receive a grant under subsection (a)(1), an entity shall—
p.001051: (A) be a consortium consisting of—
p.001051: (i) at least one teaching health center; and
p.001051: (ii) the sponsoring institution (or parent institu- tion of the sponsoring institution) of—
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p.001053: (I) a psychiatry residency program that is ac- credited by the Accreditation Council of Graduate Medical
p.001053: Education (or the parent institution of such a program); or
p.001053: (II) a fellowship in addiction medicine, as de- termined appropriate by the Secretary; or
p.001053: (B) be an entity described in subparagraph (A)(ii) that provides opportunities for residents or fellows to train
p.001053: in community-based settings that integrate primary care with mental and substance use disorders prevention and
p.001053: treat- ment services.
p.001053: (2) TRAINING FOR OTHER PROVIDERS.—To be eligible to re- ceive a grant under subsection (a)(2), an entity shall
p.001053: be—
p.001053: (A) a teaching health center (as defined in section 749A(f));
p.001053: (B) a Federally qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act);
p.001053: (C) a community mental health center (as defined in section 1861(ff)(3)(B) of the Social Security Act);
p.001053: (D) a rural health clinic (as defined in section 1861(aa) of the Social Security Act);
p.001053: (E) a health center operated by the Indian Health Service, an Indian tribe, a tribal organization, or an urban
p.001053: Indian organization (as defined in section 4 of the Indian Health Care Improvement Act); or
p.001053: (F) an entity with a demonstrated record of success in providing training for nurse practitioners, physician assist-
p.001053: ants, health service psychologists, and social workers.
p.001053: (3) ACADEMIC UNITS OR PROGRAMS.—To be eligible to re- ceive a grant under subsection (a)(3), an
p.001053: entity shall be a school of medicine or osteopathic medicine, a nursing school, a physician assistant training
p.001053: program, a school of pharmacy, a school of social work, an accredited public or nonprofit private hospital, an
p.001053: accredited medical residency program, or a public or private nonprofit entity which the Secretary has determined
p.001053: is capable of carrying out such grant.
p.001053: (d) PRIORITY.—
p.001053: (1) IN GENERAL.—In awarding grants under subsection (a)(1) or (a)(2), the Secretary shall give priority to
p.001053: eligible enti- ties that—
p.001053: (A) demonstrate sufficient size, scope, and capacity to undertake the requisite training of an appropriate
p.001053: number of psychiatric residents, fellows, nurse practitioners, physi- cian assistants, or social workers in addiction
p.001053: medicine per year to meet the needs of the area served;
p.001053: (B) demonstrate experience in training providers to practice team-based care that integrates mental and
p.001053: sub- stance use disorder prevention and treatment services with primary care in community-based settings;
p.001053: (C) demonstrate experience in using health informa- tion technology and, as appropriate, telehealth to
p.001053: sup- port—
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p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
p.001053: dis- tribution of mental and substance use disorders services;
p.001053: (B) an analysis of the effect of the demonstration pro- gram on the prevalence of untreated mental and substance
p.001053: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001055: PUBLIC HEALTH SERVICE ACT
p.001055: Sec. 761
p.001055:
p.001055: use disorders in the surrounding communities of health centers participating in the demonstration; and
p.001055: (C) recommendations on whether the demonstration program should be expanded.
p.001055: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $10,000,000
p.001055: for each of fiscal years 2018 through 2022.
p.001055:
p.001055: PART E—HEALTH PROFESSIONS AND PUBLIC HEALTH WORKFORCE
p.001055: Subpart 1—Health Professions Workforce Information and Analysis
p.001055:
p.001055: SEC. 761. ø294n¿ HEALTH PROFESSIONS WORKFORCE INFORMATION AND ANALYSIS.
p.001055: (a) PURPOSE.—It is the purpose of this section to—
p.001055: (1) provide for the development of information describing the health professions workforce and the analysis of
p.001055: workforce related issues; and
p.001055: (2) provide necessary information for decision-making re- garding future directions in health professions
p.001055: and nursing programs in response to societal and professional needs.
p.001055: (b) NATIONAL CENTER FOR HEALTH CARE WORKFORCE ANAL-
p.001055: YSIS.—
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p.001063: private entities in the fields with respect to which the traineeships are awarded.
p.001063: SEC. 770. ø295e¿ AUTHORIZATION OF APPROPRIATIONS.
p.001063: (a) IN GENERAL.—For the purpose of carrying out this subpart, there is authorized to be appropriated $43,000,000
p.001063: for fiscal year
p.001063: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001063: Sec. 775 PUBLIC HEALTH SERVICE ACT 1064
p.001063:
p.001063: 2011, and such sums as may be necessary for each of the fiscal years 2012 through 2015.
p.001063: (b) LIMITATION REGARDING CERTAIN PROGRAM.—In obligating amounts appropriated under subsection (a), the
p.001063: Secretary may not obligate more than 30 percent for carrying out section 767.
p.001063: Subpart 3—Recruitment and Retention Programs
p.001063:
p.001063: SEC. 775. ø295f¿ INVESTMENT IN TOMORROW’S PEDIATRIC HEALTH CARE WORKFORCE.
p.001063: (a) ESTABLISHMENT.—The Secretary shall establish and carry out a pediatric specialty loan repayment program under
p.001063: which the eligible individual agrees to be employed full-time for a specified period (which shall not be less
p.001063: than 2 years) in providing pediatric medical subspecialty, pediatric surgical specialty, or child and ado- lescent
p.001063: mental and behavioral health care, including substance abuse prevention and treatment services.
p.001063: (b) PROGRAM ADMINISTRATION.—Through the program estab- lished under this section, the Secretary shall enter
p.001063: into contracts with qualified health professionals under which—
p.001063: (1) such qualified health professionals will agree to provide pediatric medical subspecialty, pediatric surgical
p.001063: specialty, or child and adolescent mental and behavioral health care in an area with a shortage of the
p.001063: specified pediatric subspecialty that has a sufficient pediatric population to support such pediatric
p.001063: subspecialty, as determined by the Secretary; and
p.001063: (2) the Secretary agrees to make payments on the prin- cipal and interest of undergraduate, graduate, or
p.001063: graduate medical education loans of professionals described in para- graph (1) of not more than $35,000
p.001063: a year for each year of agreed upon service under such paragraph for a period of not more than 3
p.001063: years during the qualified health professional’s—
p.001063: (A) participation in an accredited pediatric medical subspecialty, pediatric surgical specialty, or child and
p.001063: ado- lescent mental health subspecialty residency or fellowship; or
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p.001065: 1065
p.001065: PUBLIC HEALTH SERVICE ACT
p.001065: Sec. 776
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p.001065: (B) CHILD AND ADOLESCENT MENTAL AND BEHAVIORAL HEALTH.—For purposes of contracts with respect to child and
p.001065: adolescent mental and behavioral health care, the term ‘‘qualified health professional’’ means a health
p.001065: care professional who—
p.001065: (i) has received specialized training or clinical ex- perience in child and adolescent mental health in psy-
p.001065: chiatry, psychology, school psychology, behavioral pe- diatrics, psychiatric nursing, social work, school social
p.001065: work, substance abuse disorder prevention and treat- ment, marriage and family therapy, school counseling, or
p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
...

p.001067: (e) GENERAL SUPPORT.—Amounts may be used from grants awarded under this section to expand the
p.001067: Public Health Informatics Fellowship Program at the Centers for Disease Control and Prevention to better
p.001067: support all public health systems at all levels of government.
p.001067: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $39,500,000
p.001067: for each of fiscal years 2010 through 2013, of which—
p.001067: (1) $5,000,000 shall be made available in each such fiscal year for epidemiology fellowship training
p.001067: program activities under subsections (b) and (c);
p.001067: (2) $5,000,000 shall be made available in each such fiscal year for laboratory fellowship training
p.001067: programs under sub- section (b);
p.001067: (3) $5,000,000 shall be made available in each such fiscal year for the Public Health Informatics
p.001067: Fellowship Program under subsection (e); and
p.001067: (4) $24,500,000 shall be made available for expanding the Epidemic Intelligence Service under subsection (a).
p.001067: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001069: 1069
p.001069: PUBLIC HEALTH SERVICE ACT
p.001069:
p.001069: PART F—SUBSTANCE USE DISORDER TREATMENT WORKFORCE
p.001069: Sec. 781
p.001069:
p.001069: SEC. 781. ø295h¿ LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT WORKFORCE.
p.001069: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001069: Administration, shall carry out a program under which—
p.001069: (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection
p.001069: (b) on the principal of and interest on any eligible loan; and
p.001069: (2) the individuals each agree to the requirements of serv- ice in substance use disorder treatment employment,
p.001069: as de- scribed in subsection (d).
p.001069: (b) PAYMENTS.—For each year of obligated service by an indi- vidual pursuant to an agreement under
p.001069: subsection (a), the Sec- retary shall make a payment to such individual as follows:
p.001069: (1) SERVICE IN A SHORTAGE AREA.—The Secretary shall pay—
p.001069:
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p.001069: (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1⁄6 of
p.001069: the principal of and interest on each eligible loan of the indi- vidual which is outstanding on the
p.001069: date the individual began service pursuant to the agreement; and
p.001069: (B) for completion of the sixth and final year of such service, the remainder of such principal and interest.
p.001069: (2) MAXIMUM AMOUNT.—The total amount of payments under this section to any individual shall not exceed $250,000.
p.001069: (c) ELIGIBLE LOANS.—The loans eligible for repayment under this section are each of the following:
p.001069: (1) Any loan for education or training for a substance use disorder treatment employment.
p.001069: (2) Any loan under part E of title VIII (relating to nursing student loans).
p.001069: (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or
p.001069: Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).
p.001069: (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.
p.001069: (5) Any other Federal loan as determined appropriate by the Secretary.
p.001069: (d) REQUIREMENTS OF SERVICE.—Any individual receiving pay- ments under this program as required by an agreement under
p.001069: sub- section (a) shall agree to an annual commitment to full-time em- ployment, with no more than 1
p.001069: year passing between any 2 years of covered employment, in substance use disorder treatment em- ployment
p.001069: in the United States in—
p.001069: (1) a Mental Health Professional Shortage Area, as des- ignated under section 332; or
p.001069: (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per
p.001069: 100,000 people over the past 3 years for which official data is available from the State, is higher than the
p.001069: most recent available na-
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001069: Prevention.
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p.001069: under this section.
p.001069: (g) ADDITIONAL CRITERIA.—The Secretary—
p.001069: (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed
p.001069: and in addition to the criteria and rules specified in this section; and
p.001069: (2) shall give notice to the committees specified in sub- section (h) of any criteria and rules so
p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
p.001071: center-affili- ated treatment program), correctional facility or program, youth detention center or program,
p.001071: inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or
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p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
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p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
p.001091:
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p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001091:
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p.001091: Sec. 831 PUBLIC HEALTH SERVICE ACT 1092
p.001091:
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p.001091: January 30, 2020
p.001091:
p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
p.001091: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to paragraph
p.001091: (1) or (2).
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p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
p.001197: (D) develop best practices in areas such as family or consumer support, return to work, housing or
p.001197: supportive living personal assistance services, assistive technology and devices, behavioral health
p.001197: services, substance abuse services, and traumatic brain injury treatment and reha- bilitation;
p.001197: (E) tailor existing State or American Indian consor- tium systems to provide accommodations to the needs
p.001197: of individuals with traumatic brain injury (including systems administered by the State or American Indian
p.001197: consortium departments responsible for health, mental health, labor/ employment, education, intellectual
p.001197: disabilities or develop- mental disorders, transportation, and correctional sys- tems);
p.001197: (F) improve data sets coordinated across systems and other needs identified by a State or American
p.001197: Indian con- sortium plan supported by its advisory council; and
p.001197: (G) develop capacity within targeted communities.
p.001197: (f) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.001197: coordinated as appropriate
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001197:
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p.001199: 1199
p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
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p.001269: Sec. 1703
p.001269:
p.001269: and preventive measures could be implemented to improve health as it is affected by such factors;
p.001269: (4) develop (A) methods by which the cost and effectiveness of activities respecting health information and
p.001269: health pro- motion, preventive health services, and education in the appro- priate use of health care, can be
p.001269: measured, including methods for evaluating the effectiveness of various settings for such ac- tivities and the various
p.001269: types of persons engaged in such activi- ties, (B) methods for reimbursement or payment for such ac- tivities,
p.001269: and (C) models and standards for the conduct of such activities, including models and standards for the
p.001269: education, by providers of institutional health services, of individuals receiv- ing such services respecting the
p.001269: nature of the institutional health services provided the individuals and the symptoms, signs, or diagnoses
p.001269: which led to provision of such services;
p.001269: (5) develop a method for assessing the cost and effective- ness of specific medical services and procedures
p.001269: under various conditions of use, including the assessment of the sensitivity and specificity of screening and
p.001269: diagnostic procedures; and
p.001269: (6) enumerate and assess, using methods developed under paragraph (5), preventive health measures and services
p.001269: with respect to their cost and effectiveness under various conditions of use (which measures and services may
p.001269: include blood pres- sure screening, cholesterol screening and control, smoking ces- sation programs, substance
p.001269: abuse programs, cancer screening, dietary and nutritional counseling, diabetes screening and edu- cation,
p.001269: intraocular pressure screening, and stress manage- ment).
p.001269: (b) The Secretary shall make a periodic survey of the needs, in- terest, attitudes, knowledge, and behavior of
p.001269: the American public regarding health and health care. The Secretary shall take into consideration the
p.001269: findings of such surveys and the findings of simi- lar surveys conducted by national and community health education
p.001269: organizations, and other organizations and agencies for formulating policy respecting health information and health
p.001269: promotion, preven- tive health services, and education in the appropriate use of health care.
p.001269:
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p.001269:
p.001269: January 30, 2020
p.001269:
p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
...

p.001277: (1) The term ‘‘racial and ethnic minority group’’ means American Indians (including Alaska Natives,
p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
p.001277: Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administra-
p.001277: tion, and the Centers for Medicare & Medicaid Services.
p.001277: (c) DIRECTOR; APPOINTMENT.—Each Office of Minority Health established in an agency listed in subsection (a) shall
p.001277: be headed by a director, with documented experience and expertise in minority health services research and
p.001277: health disparities elimination.
p.001277: (d) REFERENCES.—Except as otherwise specified, any reference in Federal law to an Office of Minority Health (in the
p.001277: Department of Health and Human Services) is deemed to be a reference to the Office of Minority Health in the Office of
p.001277: the Secretary.
p.001277: (e) FUNDING.—
p.001277: (1) ALLOCATIONS.—Of the amounts appropriated for a spec- ified agency for a fiscal year, the Secretary must designate
p.001277: an appropriate amount of funds for the purpose of carrying out ac- tivities under this section through the minority
p.001277: health office of the agency. In reserving an amount under the preceding sen- tence for a minority health
p.001277: office for a fiscal year, the Sec- retary shall reduce, by substantially the same percentage, the amount
p.001277: that otherwise would be available for each of the pro- grams of the designated agency involved.
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p.001279:
p.001279: EDUCATION REGARDING DES
p.001279: SEC. 1710. ø300u–9¿ (a) IN GENERAL.—The Secretary, acting through the heads of the appropriate agencies of the
p.001279: Public Health Service, shall carry out a national program for the education of health professionals and
p.001279: the public with respect to the drug diethylstilbestrol (commonly known as DES). To the extent
p.001279: appro- priate, such national program shall use methodologies developed through the education demonstration
p.001279: program carried out under section 403C. In developing and carrying out the national program, the Secretary shall
p.001279: consult closely with representatives of nonprofit private entities that represent individuals who have been
p.001279: exposed to DES and that have expertise in community-based information campaigns for the public and for health
p.001279: care providers. The imple- mentation of the national program shall begin during fiscal year 1999.
p.001279: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001279: to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The
p.001279: authorization of appropriations established in the preceding sentence is in addition to any other authorization of
p.001279: appropriation that is available for such purpose.
p.001279: SEC. 1711. ø300u–16¿ ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION DASHBOARD.
p.001279: (a) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Secretary of Health
p.001279: and Human Services shall, in consultation with the Director of National Drug Control Policy, establish
p.001279: and periodically update, on the Internet website of the Department of Health and Human Services, a public
p.001279: information dashboard that—
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
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p.001279: Sec. 1801 PUBLIC HEALTH SERVICE ACT 1280
p.001279:
p.001279: (1) provides links to information on programs within the Department of Health and Human Services related
p.001279: to the re- duction of opioid and other substance use disorders;
p.001279: (2) provides access, to the extent practicable and appro- priate, to publicly available data, which may include
p.001279: data from agencies within the Department of Health and Human Serv- ices and—
p.001279: (A) other Federal agencies;
p.001279: (B) State, local, and Tribal governments;
p.001279: (C) nonprofit organizations;
p.001279: (D) law enforcement;
p.001279: (E) medical experts;
p.001279: (F) public health educators; and
p.001279: (G) research institutions regarding prevention, treat- ment, recovery, and other services for opioid and
p.001279: other substance use disorders;
p.001279: (3) provides data on substance use disorder prevention and treatment strategies in different regions of and
p.001279: populations in the United States;
p.001279: (4) identifies information on alternatives to controlled sub- stances for pain management, such as approaches
p.001279: studied by the National Institutes of Health Pain Consortium, the Na- tional Center for Complimentary and
p.001279: Integrative Health, and other institutes and centers at the National Institutes of Health, as
p.001279: appropriate; and
p.001279: (5) identifies guidelines and best practices for health care providers regarding treatment of substance use
p.001279: disorders.
p.001279: (b) CONTROLLED SUBSTANCE DEFINED.—In this section, the term ‘‘controlled substance’’ has the meaning
p.001279: given that term in section 102 of the Controlled Substances Act (21 U.S.C. 802).
p.001279: TITLE XVIII—PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND
p.001279: BEHAVIORAL RESEARCH
p.001279: ESTABLISHMENT OF COMMISSION
p.001279: SEC. 1801. ø300v¿ (a) ESTABLISHMENT.—(1) There is estab-
p.001279: lished the President’s Commission for the Study of Ethical Prob- lems in Medicine and Biomedical and
p.001279: Behavioral Research 1 (here- inafter in this title referred to as the ‘‘Commission’’) which shall be composed of
p.001279: eleven members appointed by the President. The mem- bers of the Commission shall be appointed as follows:
p.001279: (A) Three of the members shall be appointed from individ- uals who are distinguished in biomedical or behavioral
p.001279: re- search.
p.001279: (B) Three of the members shall be appointed from individ- uals who are distinguished in the practice of medicine or
p.001279: other- wise distinguished in the provision of health care.
p.001279: (C) Five of the members shall be appointed from individ- uals who are distinguished in one or more of the
p.001279: fields of eth-
p.001279:
p.001279:
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p.001279:
p.001279: January 30, 2020
p.001279: 1 Such a Commission was established on December 17, 1979, by Executive Order No. 12184 (44 Fed. Reg.
p.001279: 75091). The Executive Order was revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed. Reg.
p.001279: 7237).
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001295: will provide significant benefits through the collection, analysis, and dissemination of information or data
p.001295: which will be useful to States in which grants under such subsection have not been made.
p.001295: (c) For purposes of this section—
p.001295: (1) the term ‘‘school of medicine’’ has the same meaning as in section 701(4); and
p.001295: (2) the term ‘‘accredited’’ has the same meaning as in sec- tion 701(5).
p.001295: (d) To carry out this section, there are authorized to be appro- priated $2,000,000 for fiscal year 1985 and for each
p.001295: of the two suc- ceeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000
p.001295: for each of the fiscal years 1991 and 1992, such sums as may be necessary for each of the fiscal
p.001295: years 1993 through 2005, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
p.001295: for fiscal year 2012, $28,940,625
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001295:
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p.001295: Sec. 1911 PUBLIC HEALTH SERVICE ACT 1296
p.001295:
p.001295: for fiscal year 2013, $30,387,656 for fiscal year 2014, $20,213,000 for each of fiscal years 2015
p.001295: through 2019, and $22,334,000 for each of fiscal years 2020 through 2024.
p.001295: PART B—BLOCK GRANTS REGARDING MENTAL HEALTH AND
p.001295: SUBSTANCE ABUSE
p.001295:
p.001295: Subpart I—Block Grants for Community Mental Health Services
p.001295: SEC. 1911. ø300x¿ FORMULA GRANTS TO STATES.
p.001295: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Director of the
p.001295: Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined
p.001295: in accordance with section 1918. The Secretary shall make a grant to the State of the allotment made
p.001295: for the State for the fiscal year if the State submits to the Secretary an application in accordance with
p.001295: section 1917.
p.001295: (b) PURPOSE OF GRANTS.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001295: 1916, the State in- volved will expend the grant only for the purpose of—
p.001295: (1) providing community mental health services for adults with a serious mental illness and children with a serious
p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
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p.001297: 1297
p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
p.001297: (I) a description of the activities intended to reduce hospitalizations and hospital stays using the block
p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001297:
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p.001297: Sec. 1912 PUBLIC HEALTH SERVICE ACT 1298
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p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
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p.001307: (1) IN GENERAL.—For the purpose of carrying out section 1948(a) with respect to mental health and the
p.001307: purposes speci- fied in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts
p.001307: appropriated under subsection (a) for a fiscal year.
p.001307: (2) DATA COLLECTION.—The purpose specified in this para- graph is carrying out sections 505(c) and 1971 with
p.001307: respect to mental health.
p.001307: (3) PROGRAM EVALUATION.—The purpose specified in this paragraph is the conduct of evaluations of
p.001307: prevention and treatment programs and services with respect to mental health to determine methods for improving
p.001307: the availability and qual- ity of such programs and services.
p.001307: (c) EARLY SERIOUS MENTAL ILLNESS.—
p.001307: (1) IN GENERAL.—Except as provided in paragraph (2), a State shall expend not less than 10 percent of the
p.001307: amount the State receives for carrying out this section for each fiscal year to support evidence-based programs
p.001307: that address the needs of individuals with early serious mental illness, including psy- chotic disorders,
p.001307: regardless of the age of the individual at onset.
p.001307: (2) STATE FLEXIBILITY.—In lieu of expending 10 percent of the amount the State receives under this section for
p.001307: a fiscal year as required under paragraph (1), a State may elect to ex- pend not less than 20 percent of such
p.001307: amount by the end of such succeeding fiscal year.
p.001307:
p.001307: Subpart II—Block Grants for Prevention and Treatment of Substance Abuse
p.001307:
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p.001307: January 30, 2020
p.001307: SEC. 1921. ø300x–21¿ FORMULA GRANTS TO STATES.
p.001307: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Center for
p.001307: Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in
p.001307: accordance with section 1933. The Sec- retary shall make a grant to the State of the allotment made for the
p.001307: State for the fiscal year if the State submits to the Secretary an application in accordance with section
p.001307: 1932.
p.001307: (b) AUTHORIZED ACTIVITIES.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001307: 1931, the State in- volved will expend the grant only for the purpose of carrying out the plan developed
p.001307: in accordance with section 1932(b) and for plan- ning, carrying out, and evaluating activities to prevent and
p.001307: treat substance use disorders and for related activities authorized in sec- tion 1924.
p.001307: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001309: 1309
p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
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p.001309: January 30, 2020
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p.001309: graph, as indicated by a comparison of the number of such women seeking the services with the availability in
p.001309: the State of the services.
p.001309: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001309: 120 days after the date on which the request is made.
p.001309: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001309: in- volved.
p.001309: (3) CHILDCARE AND PRENATAL CARE.—A funding agreement for a grant under section 1921 for a State is that
p.001309: each entity providing treatment services with amounts reserved under paragraph (1) by the State will,
p.001309: directly or through arrange- ments with other public or nonprofit private entities, make available
p.001309: prenatal care to women receiving such services and, while the women are receiving the services, childcare.
p.001309: SEC. 1923. ø300x–23¿ INTRAVENOUS SUBSTANCE ABUSE.
p.001309: (a) CAPACITY OF TREATMENT PROGRAMS.—
p.001309: (1) NOTIFICATION OF REACHING CAPACITY.—A funding agreement for a grant under section 1921 is that the
p.001309: State in- volved will, in the case of programs of treatment for intra- venous drug abuse, require that
p.001309: any such program receiving amounts from the grant, upon reaching 90 percent of its capac- ity to admit
p.001309: individuals to the program, provide to the State a notification of such fact.
p.001309: (2) PROVISION OF TREATMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001309: will, with respect to notifications under paragraph (1), ensure that each individual who requests and is
p.001309: in need of treatment for intra- venous drug abuse is admitted to a program of such treatment not later than—
p.001309: (A) 14 days after making the request for admission to such a program; or
p.001309: (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on
p.001309: the date of such request and if interim services are made available to the individual not later than 48
p.001309: hours after such request.
p.001309: (b) OUTREACH TO PERSONS WHO INJECT DRUGS.—A funding agreement for a grant under section 1921 is
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p.001311: treatment for the disease that is appropriate for the in- dividual; and
p.001311: (C) providing such treatment to the individual.
p.001311: (b) HUMAN IMMUNODEFICIENCY VIRUS.—
p.001311: (1) REQUIREMENT FOR CERTAIN STATES.—In the case of a State described in paragraph (2), a funding
p.001311: agreement for a grant under section 1921 is that—
p.001311: (A) with respect to individuals undergoing treatment for substance use disorders, the State will, subject to
p.001311: para- graph (3), carry out 1 or more projects to make available to the individuals early intervention
p.001311: services for HIV dis- ease at the sites at which the individuals are undergoing such treatment;
p.001311: (B) for the purpose of providing such early interven- tion services through such projects, the State
p.001311: will make available from the grant the percentage that is applicable for the State under paragraph (4); and
p.001311: (C) the State will, subject to paragraph (5), carry out such projects only in geographic areas of the
p.001311: State that have the greatest need for the projects.
p.001311: (2) DESIGNATED STATES.—For purposes of this subsection, a State described in this paragraph is any State
p.001311: whose rate of cases of acquired immune deficiency syndrome is 10 or more such cases per 100,000 individuals
p.001311: (as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control
p.001311: and Prevention for the most recent calendar year for which such data are available).
p.001311: (3) USE OF EXISTING PROGRAMS REGARDING SUBSTANCE USE DISORDERS.—With respect to programs that provide
p.001311: treatment services for substance use disorders, a funding agreement for a grant under section 1921 for a
p.001311: designated State is that each such program participating in a project under paragraph (1) will be a program
p.001311: that began operation prior to the fiscal year for which the State is applying to receive the grant. A program that so
p.001311: began operation may participate in a project under paragraph (1) without regard to whether the program has been
p.001311: providing early intervention services for HIV disease.
p.001311: (4) APPLICABLE PERCENTAGE REGARDING EXPENDITURES FOR SERVICES.—
p.001311: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001311: Sec. 1924 PUBLIC HEALTH SERVICE ACT 1312
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p.001311: January 30, 2020
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p.001311: (A)(i) For purposes of paragraph (1)(B), the percentage that is applicable under this paragraph for a
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p.001315: 1315
p.001315: PUBLIC HEALTH SERVICE ACT
p.001315: Sec. 1926
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p.001315: January 30, 2020
p.001315: (i) certifies to the Secretary by May 1 of the fiscal year for which the funds are appropriated, consistent with
p.001315: subparagraph (B), that the State will commit ad- ditional State funds, in accordance with paragraph (1), to ensure that
p.001315: retailers do not sell tobacco products to individuals under 21 years of age;
p.001315: (ii) agrees to comply with a negotiated agreement for a corrective action plan that is approved by the
p.001315: Secretary and carried out in accordance with guide- lines issued by the Secretary; or
p.001315: (iii) is a territory that receives less than
p.001315: $1,000,000 for a fiscal year under section 1921.
p.001315: (B) CERTIFICATION.—
p.001315: (i) IN GENERAL.—The amount of funds to be com- mitted by a State pursuant to subparagraph (A)(i) shall
p.001315: be equal to 1 percent of such State’s substance abuse allocation determined under section 1933 for each
p.001315: percentage point by which the State misses the retailer compliance rate goal established by the Sec-
p.001315: retary.
p.001315: (ii) STATE EXPENDITURES.—For a fiscal year in which a State commits funds as described in clause (i), such State
p.001315: shall maintain State expenditures for to- bacco prevention programs and for compliance activi- ties at a
p.001315: level that is not less than the level of such expenditures maintained by the State for the pre- ceding
p.001315: fiscal year, plus the additional funds for tobacco compliance activities required under clause (i). The State
p.001315: shall submit a report to the Secretary on all State obligations of funds for such fiscal year and all
p.001315: State expenditures for the preceding fiscal year for to- bacco prevention and compliance activities by program activity
p.001315: by July 31 of such fiscal year.
p.001315: (iii) DISCRETION.—The Secretary shall exercise discretion in enforcing the timing of the State obliga-
p.001315: tion of the additional funds required by the certifi- cation described in subparagraph (A)(i) as late as July
p.001315: 31 of such fiscal year.
p.001315: (C) FAILURE TO CERTIFY.—If a State described in sub- paragraph (A) fails to certify to the Secretary pursuant
p.001315: to subparagraph (A)(i) or enter into, or comply with, a nego- tiated agreement under subparagraph (A)(ii), the
p.001315: Secretary may take action pursuant to paragraph (1).
p.001315: (c) IMPLEMENTATION OF REPORTING REQUIREMENTS.—
p.001315: (1) TRANSITION PERIOD.—The Secretary shall—
p.001315: (A) not withhold amounts under subsection (b) for the 3-year period immediately following the date of enactment of
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p.001315: Sec. 1927 PUBLIC HEALTH SERVICE ACT 1316
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p.001315: January 30, 2020
p.001315:
p.001315: (2) REGULATIONS OR GUIDANCE.—Not later than 180 days after the date of enactment of division N of the
p.001315: Further Con- solidated Appropriations Act, 2020, the Secretary shall update regulations under part 96 of title
p.001315: 45, Code of Federal Regula- tions or guidance on the retailer compliance rate goal under subsection (b),
p.001315: the use of funds provided under section 1921 for purposes of meeting the requirements of this section, and re-
p.001315: porting requirements under subsection (a)(2).
p.001315: (3) COORDINATION.—The Secretary shall ensure the Assist- ant Secretary for Mental Health and Substance Use
p.001315: coordi- nates, as appropriate, with the Commissioner of Food and Drugs to ensure that the technical
p.001315: assistance provided to States under subsection (e) is consistent with applicable regu- lations for
p.001315: retailers issued under part 1140 of title 21, Code of Federal Regulations.
p.001315: (d) TRANSITIONAL GRANTS.—
p.001315: (1) IN GENERAL.—The Secretary shall award grants under this subsection to each State that receives
p.001315: funding under sec- tion 1921 to ensure compliance of each such State with this section.
p.001315: (2) USE OF FUNDS.—A State receiving a grant under this subsection—
p.001315: (A) shall use amounts received under such grant for activities to plan for or ensure compliance in the
p.001315: State with subsection (a); and
p.001315: (B) in the case of a State for which the Secretary has made a determination under subsection (b) that the State
p.001315: is prepared to meet, or has met, the requirements of sub- section (a), may use such funds for tobacco
p.001315: cessation activi- ties, strategies to prevent the use of tobacco products by individuals under the age of
p.001315: 21, or allowable uses under section 1921.
p.001315: (3) SUPPLEMENT NOT SUPPLANT.—Grants under this sub- section shall be used to supplement and not supplant
p.001315: other Federal, State, and local public funds provided for activities under paragraph (2).
p.001315: (4) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there are authorized to be
p.001315: appropriated
p.001315: $18,580,790 for each of fiscal years 2020 through 2024.
p.001315: (5) SUNSET.—This subsection shall have no force or effect after September 30, 2024.
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p.001317: the facility, the facility refer the woman to the State; and
p.001317: (2) the State, in the case of each woman for whom a refer- ral under paragraph (1) is made to the State—
p.001317: (A) will refer the woman to a treatment facility that has the capacity to provide treatment
p.001317: services to the woman; or
p.001317: (B) will, if no treatment facility has the capacity to admit the woman, make interim services available
p.001317: to the woman not later than 48 hours after the women 6 seeks the treatment services.
p.001317: SEC. 1928. ø300x–28¿ ADDITIONAL AGREEMENTS.
p.001317: (a) IMPROVEMENT OF PROCESS FOR APPROPRIATE REFERRALS FOR TREATMENT.—With respect to individuals
p.001317: seeking treatment services, a funding agreement for a grant under section 1921 is that the State involved
p.001317: will improve the process in the State for re- ferring the individuals to treatment facilities that can provide
p.001317: to the individuals the treatment modality that is most appropriate for the individuals.
p.001317: (b) PROFESSIONAL DEVELOPMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001317: will ensure that prevention, treatment, and recovery personnel operating in the State’s substance use disorder
p.001317: prevention, treatment, and recovery systems have an opportunity to receive training, on an ongoing basis,
p.001317: concerning—
p.001317: (1) recent trends in substance use disorders in the State;
p.001317: (2) improved methods and evidence-based practices for pro- viding substance use disorder prevention and treatment
p.001317: serv- ices;
p.001317: (3) performance-based accountability;
p.001317: (4) data collection and reporting requirements; and
p.001317: (5) any other matters that would serve to further improve the delivery of substance use disorder prevention and
p.001317: treat- ment services within the State.
p.001317: (c) COORDINATION OF VARIOUS ACTIVITIES AND SERVICES.—A funding agreement for a grant under section 1921 is
p.001317: that the State involved will coordinate prevention and treatment activities with the provision of other
p.001317: appropriate services (including health, social, correctional and criminal justice, educational, vocational rehabilita-
p.001317: tion, and employment services).
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p.001317: January 30, 2020
p.001317: 6 So in law. See section 202 of Public Law 102–321 (106 Stat. 396). Probably should be ‘‘woman’’.
p.001317: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: Sec. 1930 PUBLIC HEALTH SERVICE ACT 1318
p.001317:
p.001317: (d) 8 WAIVER OF REQUIREMENT.—
p.001317: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may provide to a State a waiver of any or all of
p.001317: the re- quirements established in this section if the Secretary deter- mines that, with respect to
p.001317: services for the prevention and treatment of substance use disorders, the requirement involved is unnecessary for
p.001317: maintaining quality in the provision of such services in the State.
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p.001319: Sec. 1931 PUBLIC HEALTH SERVICE ACT 1320
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p.001319:
p.001319: January 30, 2020
p.001319:
p.001319: pose of providing treatment services in penal or correctional in- stitutions of the State, the State will not expend
p.001319: more than an amount equal to the amount expended for such purpose by the State from the grant made under section
p.001319: 1912A to the State for fiscal year 1991 (as section 1912A was in effect for such fis- cal year).
p.001319: (b) EXCEPTION REGARDING INPATIENT HOSPITAL SERVICES.—
p.001319: (1) MEDICAL NECESSITY AS PRECONDITION.—With respect to compliance with the agreement made under subsection
p.001319: (a), a State may expend a grant under section 1921 to provide inpa- tient hospital services as treatment for substance
p.001319: use disorders only if it has been determined, in accordance with guidelines issued by the Secretary, that
p.001319: such treatment is a medical ne- cessity for the individual involved, and that the individual can- not be
p.001319: effectively treated in a community-based, nonhospital, residential program of treatment.
p.001319: (2) RATE OF PAYMENT.—In the case of an individual for whom a grant under section 1921 is expended to provide
p.001319: inpa- tient hospital services described in paragraph (1), a funding agreement for the grant for the State
p.001319: involved is that the daily rate of payment provided to the hospital for providing the serv- ices to the individual will
p.001319: not exceed the comparable daily rate provided for community-based, nonhospital, residential pro- grams of
p.001319: treatment for substance abuse.
p.001319: (c) WAIVER REGARDING CONSTRUCTION OF FACILITIES.—
p.001319: (1) IN GENERAL.—The Secretary may provide to any State a waiver of the restriction established in
p.001319: subsection (a)(1)(C) for the purpose of authorizing the State to expend a grant under section 1921 for the
p.001319: construction of a new facility or re- habilitation of an existing facility, but not for land acquisition.
p.001319: (2) STANDARD REGARDING NEED FOR WAIVER.—The Sec- retary may approve a waiver under paragraph (1) only
p.001319: if the State demonstrates to the Secretary that adequate treatment cannot be provided through the use of
p.001319: existing facilities and that alternative facilities in existing suitable buildings are not available.
p.001319: (3) AMOUNT.—In granting a waiver under paragraph (1), the Secretary shall allow the use of a specified amount of
p.001319: funds to construct or rehabilitate a specified number of beds for resi- dential treatment and a specified number
p.001319: of slots for out- patient treatment, based on reasonable estimates by the State of the costs of construction or
p.001319: rehabilitation. In considering waiver applications, the Secretary shall ensure that the State has carefully
p.001319: designed a program that will minimize the costs of additional beds.
p.001319: (4) MATCHING FUNDS.—The Secretary may grant a waiver under paragraph (1) only if the State agrees, with
p.001319: respect to the costs to be incurred by the State in carrying out the pur- pose of the waiver, to make
p.001319: available non-Federal contribu- tions in cash toward such costs in an amount equal to not less than $1 for each
p.001319: $1 of Federal funds provided under section 1921.
...

p.001321: (other than any such agreement that is not applicable to the State);
p.001321: (3) the agreements are made through certification from the chief executive officer of the State;
p.001321: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001321: Secretary;
p.001321: (5) the application contains the report required in section 1942(a);
p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
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p.001321:
p.001321: Sec. 1932 PUBLIC HEALTH SERVICE ACT 1322
p.001321:
p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
p.001321: (ix) describes how the State integrates substance use disorder services and primary health care, which in
p.001321: the case of those individuals with co-occurring men- tal health and substance use disorders may include
p.001321: providing both mental health and substance use dis- order services in primary care settings or providing
p.001321: primary and specialty care services in community- based mental health and substance use disorder serv- ice
p.001321: settings.
p.001321: (B) The establishment of goals and objectives for the period of the plan, including targets and
p.001321: milestones that are intended to be met, and the activities that will be un- dertaken to achieve those targets.
p.001321: (C) A description of how the State will comply with each funding agreement for a grant under section
p.001321: 1921 that is applicable to the State, including a description of the manner in which the State intends
p.001321: to expend grant funds.
p.001321: (2) MODIFICATIONS.—
p.001321: (A) AUTHORITY OF SECRETARY.—As a condition; 9 of making a grant under section 1921 to a State for a
p.001321: fiscal year, the Secretary may require that the State modify any provision of the plan submitted by the State
p.001321: under sub- section (a)(6) (including provisions on priorities in carrying out authorized activities). If the
p.001321: Secretary approves the plan and makes the grant to the State for the fiscal year, the Secretary may not
p.001321: during such year require the State to modify the plan.
p.001321: (B) STATE REQUEST FOR MODIFICATION.—If the State determines that a modification to such plan is
p.001321: necessary, the State may request the Secretary to approve the modi- fication. Any such modification shall be
p.001321: in accordance with paragraph (1) and section 1941.
p.001321:
p.001321:
p.001321:
p.001321:
p.001321: January 30, 2020
p.001321: 9 The semicolon after ‘‘a condition’’ in paragraph (2)(A) probably should not appear. See amendment made by
p.001321: section 8002(i)(2)(B)(ii) of Public Law 114–255.
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
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p.001321:
p.001323: 1323
p.001323: PUBLIC HEALTH SERVICE ACT
p.001323: Sec. 1933
p.001323:
p.001323: (3) AUTHORITY OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—With respect to plans submitted by the States
p.001323: under subsection (a)(6), including any modification under paragraph (2), the Secretary, acting through the
p.001323: Director of the Center for Substance Abuse Prevention, shall review and approve or dis- approve the
p.001323: provisions of the plans that relate to prevention activities.
p.001323: (c) WAIVERS REGARDING CERTAIN TERRITORIES.—In the case of any territory of the United States except Puerto Rico, the
p.001323: Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be
p.001323: appropriate, other than the provisions of section 1931.
p.001323: (d) ISSUANCE OF REGULATIONS; PRECONDITION TO MAKING GRANTS.—
p.001323: (1) REGULATIONS.—Not later than August 25, 1992, the Secretary, acting as appropriate through the Director
p.001323: of the Center for Treatment Improvement or the Director of the Cen- ter for Substance Abuse Prevention, shall by
p.001323: regulation estab- lish standards specifying the circumstances in which the Sec- retary will consider an
p.001323: application for a grant under section 1921 to be in accordance with this section.
p.001323: (2) ISSUANCE AS PRECONDITION TO MAKING GRANTS.—The Secretary may not make payments under any grant under
p.001323: sec- tion 1921 for fiscal year 1993 on or after January 1, 1993, un- less the Secretary has issued standards
p.001323: under paragraph (1).
p.001323: (e) WAIVER AUTHORITY FOR CERTAIN REQUIREMENTS.—
p.001323: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may waive the requirements of all or part
p.001323: of the sec- tions described in paragraph (2) using objective criteria estab- lished by the Secretary by
p.001323: regulation after consultation with the States and other interested parties including consumers and providers.
p.001323: (2) SECTIONS.—The sections described in paragraph (1) are sections 1922(b) 10, 1923, 1924 and 1928.
p.001323: (3) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001323: under para- graph (1) and inform the State of that decision not later than 120 days after the date on which
p.001323: the request and all the infor- mation needed to support the request are submitted.
p.001323: (4) ANNUAL REPORTING REQUIREMENT.—The Secretary shall annually report to the general public on the
p.001323: States that receive a waiver under this subsection.
p.001323: SEC. 1933. ø300x–33¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
p.001323: (a) STATES.—
...

p.001325: abuse of alcohol and other drugs bore to the amount of the portion of the allotment under this subpart
p.001325: for the State for such fiscal year that was expended for such ac- tivities.
p.001325: (2) TRIBE OR TRIBAL ORGANIZATION AS GRANTEE.—The amount reserved by the Secretary on the basis of a
p.001325: determina- tion under this paragraph 12 shall be granted to the Indian tribe or tribal organization
p.001325: serving the individuals for whom such a determination has been made.
p.001325: (3) APPLICATION.—In order for an Indian tribe or tribal or- ganization to be eligible for a grant for a fiscal year
p.001325: under this paragraph, it shall submit to the Secretary a plan for such fis- cal year that meets such criteria as
p.001325: the Secretary may pre- scribe.
p.001325: (4) DEFINITION.—The terms ‘‘Indian tribe’’ and ‘‘tribal orga- nization’’ have the same meaning given such terms
p.001325: in sub- sections (b) and (c) of section 4 of the Indian Self-Determina- tion and Education Assistance Act.
p.001325: SEC. 1934. ø300x–34¿ DEFINITIONS.
p.001325: For purposes of this subpart:
p.001325: (1) The term ‘‘authorized activities’’, subject to section 1931, means the activities described in
p.001325: section 1921(b).
p.001325: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1921 to a State, means that the
p.001325: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001325: (3) The term ‘‘prevention activities’’, subject to section 1931, means activities to prevent substance
p.001325: use disorders.
p.001325: (4) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.001325:
p.001325:
p.001325:
p.001325:
p.001325:
p.001325: January 30, 2020
p.001325: 11 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘under this subpart’’.
p.001325: 12 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘sub- section’’.
p.001325: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001325:
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p.001325:
p.001327: 1327
p.001327: PUBLIC HEALTH SERVICE ACT
p.001327: Sec. 1941
p.001327:
p.001327: (5) The term ‘‘treatment activities’’ means treatment serv- ices and, subject to section 1931, authorized activities
p.001327: that are related to treatment services.
p.001327: (6) The term ‘‘treatment facility’’ means an entity that pro- vides treatment services.
p.001327: (7) The term ‘‘treatment services’’, subject to section 1931, means treatment for substance use disorders.
p.001327: SEC. 1935. ø300x–35¿ FUNDING.
p.001327: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, subpart III and
p.001327: section 505(d) with re- spect to substance abuse, and section 515(d), there are authorized to be
p.001327: appropriated $1,858,079,000 for each of fiscal years 2018 through 2022.. 13
p.001327: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, NATIONAL DATA BASE, DATA COLLECTION, AND PROGRAM EVALUATIONS.—
p.001327: (1) IN GENERAL.—
p.001327: (A) For the purpose of carrying out section 1948(a) with respect to substance abuse, section 515(d), and
p.001327: the purposes specified in subparagraphs (B) and (C), the Sec- retary shall obligate 5 percent of
p.001327: the amounts appro- priated under subsection (a) each fiscal year.
p.001327: (B) The purpose specified in this subparagraph is the collection of data in this paragraph 14 is
p.001327: carrying out sec- tions 505(d) and 1971 with respect to substance abuse.
p.001327: (C) The purpose specified in this subparagraph is the conduct of evaluations of authorized activities to
p.001327: determine methods for improving the availability and quality of such activities.
p.001327: (2) ACTIVITIES OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—Of the amounts reserved under paragraph (1) for a
p.001327: fis- cal year, the Secretary, acting through the Director of the Cen- ter for Substance Abuse Prevention, shall
p.001327: obligate 20 percent for carrying out paragraph (1)(C), section 1948(a) with respect to prevention activities, and
p.001327: section 515(d).
p.001327: (3) CORE DATA SET.—A State that receives a new grant, contract, or cooperative agreement from amounts
p.001327: available to the Secretary under paragraph (1), for the purposes of improv- ing the data collection, analysis and
p.001327: reporting capabilities of the State, shall be required, as a condition of receipt of funds, to collect, analyze,
p.001327: and report to the Secretary for each fiscal year subsequent to receiving such funds a core data set to
p.001327: be determined by the Secretary in conjunction with the States.
p.001327: Subpart III—General Provisions
p.001327:
p.001327: SEC. 1941. ø300x–51¿ OPPORTUNITY FOR PUBLIC COMMENT ON STATE PLANS.
p.001327: A funding agreement for a grant under section 1911 or 1921 is that the State involved will make the
p.001327: plan required in section
p.001327:
p.001327:
p.001327:
p.001327:
p.001327:
p.001327: January 30, 2020
p.001327: 13 Two periods at the end of subsection (a) is so in law. See amendment made by section 8002(k)(1)(B)
p.001327: of Public Law 114–255.
p.001327: 14 So in law. See section 202 of Public Law 102–321 (106 Stat. 403). The words ‘‘the collection of data in this
p.001327: paragraph’’ probably should not appear.
p.001327: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001327:
p.001327:
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p.001331:
p.001331:
p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001333:
p.001333: Sec. 1951 PUBLIC HEALTH SERVICE ACT 1334
p.001333:
p.001333: delegate to the States the primary responsibility for interpreting the governing provisions of this part.
p.001333: SEC. 1951. ø300x–61¿ SOLICITATION OF VIEWS OF CERTAIN ENTITIES.
p.001333: In carrying out this part, the Secretary, as appropriate, shall solicit the views of the States and other
p.001333: appropriate entities.
p.001333: SEC. 1952. 17 ø300x–62¿ AVAILABILITY TO STATES OF GRANT PAYMENTS.
p.001333: Any amounts paid to a State for a fiscal year under section 1911 or 1921 shall be available for obligation
p.001333: and expenditure until the end of the fiscal year following the fiscal year for which the amounts were paid.
p.001333: SEC. 1953. ø300x–63¿ CONTINUATION OF CERTAIN PROGRAMS.
p.001333: (a) IN GENERAL.—Of the amount allotted to the State of Ha- waii under section 1911, and the amount
p.001333: allotted to such State under section 1921, an amount equal to the proportion of Native Hawaiians residing
p.001333: in the State to the total population of the State shall be available, respectively, for carrying out the
p.001333: program in- volved for Native Hawaiians.
p.001333: (b) EXPENDITURE OF AMOUNTS.—The amount made available under subsection (a) may be expended only through
p.001333: contracts en- tered into by the State of Hawaii with public and private nonprofit organizations to enable such
p.001333: organizations to plan, conduct, and administer comprehensive substance use disorder and treatment programs
p.001333: for the benefit of Native Hawaiians. In entering into con- tracts under this section, the State of Hawaii shall give
p.001333: preference to Native Hawaiian organizations and Native Hawaiian health cen- ters.
p.001333: (c) DEFINITIONS.—For the purposes of this subsection 18, the terms ‘‘Native Hawaiian’’, ‘‘Native Hawaiian
p.001333: organization’’, and ‘‘Native Hawaiian health center’’ have the meaning given such terms in section 2308 of
p.001333: subtitle D of title II of the Anti-Drug Abuse Act of 1988.
p.001333: SEC. 1954. ø300x–64¿ DEFINITIONS.
p.001333: (a) DEFINITIONS FOR SUBPART III.—For purposes of this sub- part:
p.001333: (1) The term ‘‘program involved’’ means the program of grants established in section 1911 or 1921, or
p.001333: both, as indi- cated by whether the State involved is receiving or is applying to receive a grant under section 1911
p.001333: or 1921, or both.
p.001333: (2)(A) The term ‘‘funding agreement’’, with respect to a grant under section 1911, has the meaning given such
p.001333: term in section 1919.
p.001333: (B) The term ‘‘funding agreement’’, with respect to a grant under section 1921, has the meaning given such term
p.001333: in sec- tion 1934.
p.001333: (b) DEFINITIONS FOR PART B.—For purposes of this part:
p.001333: (1) The term ‘‘Comptroller General’’ means the Comptroller General of the United States.
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 17 Section 1952 appears according to the probable intent of the Congress. Section 3403(b) of Public Law
p.001333: 106–310 (114 Stat. 1220) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1952 ‘‘is amended to read as follows:’’.
p.001333: 18 So in law. See section 203 of Public Law 102–321 (106 Stat. 409). Probably should be ‘‘sec- tion’’.
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
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p.001335: 1335
p.001335: PUBLIC HEALTH SERVICE ACT
p.001335: Sec. 1955
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p.001335: (2) The term ‘‘State’’, except as provided in sections 1918(c)(5) and 1933(c)(5), means each of the
p.001335: several States, the District of Columbia, and each of the territories of the United States.
p.001335: (3) The term ‘‘territories of the United States’’ means each of the Commonwealth of Puerto Rico, American Samoa, Guam,
p.001335: the Commonwealth of the Northern Mariana Islands, the Vir- gin Islands, Palau, the Marshall Islands, and
p.001335: Micronesia.
p.001335: (4) The term ‘‘interim services’’, in the case of an indi- vidual in need of treatment for substance abuse
p.001335: who has been denied admission to a program of such treatment on the basis of the lack of the capacity of the
p.001335: program to admit the indi- vidual, means services for reducing the adverse health effects of such abuse,
p.001335: for promoting the health of the individual, and for reducing the risk of transmission of disease, which services
p.001335: are provided until the individual is admitted to such a pro- gram.
p.001335: SEC. 1955. ø300x–65¿ SERVICES PROVIDED BY NONGOVERNMENTAL OR-
p.001335: GANIZATIONS. 19
p.001335: (a) PURPOSES.—The purposes of this section are—
p.001335: (1) to prohibit discrimination against nongovernmental or- ganizations and certain individuals on the basis of
p.001335: religion in the distribution of government funds to provide substance abuse services under this
p.001335: title and title V, and the receipt of services under such titles; and
p.001335: (2) to allow the organizations to accept the funds to pro- vide the services to the individuals without
p.001335: impairing the reli- gious character of the organizations or the religious freedom of the individuals.
p.001335: (b) RELIGIOUS ORGANIZATIONS INCLUDED AS NONGOVERN-
p.001335: MENTAL PROVIDERS.—
p.001335: (1) IN GENERAL.—A State may administer and provide sub- stance abuse services under any program under this
p.001335: title or title V through grants, contracts, or cooperative agreements to provide assistance to beneficiaries under
p.001335: such titles with non- governmental organizations.
p.001335: (2) REQUIREMENT.—A State that elects to utilize non- governmental organizations as provided for
p.001335: under paragraph
p.001335: (1) shall consider, on the same basis as other nongovernmental organizations, religious organizations to provide
p.001335: services under substance abuse programs under this title or title V, so long as the programs under such
p.001335: titles are implemented in a man- ner consistent with the Establishment Clause of the first
p.001335: amendment to the Constitution. Neither the Federal Govern- ment nor a State or local government receiving
p.001335: funds under such programs shall discriminate against an organization that provides services under, or applies to
p.001335: provide services under, such programs, on the basis that the organization has a reli- gious character.
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p.001335: January 30, 2020
p.001335: 19 Part G of title V of this Act (the second part G; see page 677) also relates to religious orga- nizations as
p.001335: providers of substance abuse services. That part was added by section 144 of the Community Renewal Tax
p.001335: Relief Act of 2000 (as enacted into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A–619). Section
p.001335: 1955 above was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001335: Sec. 1955 PUBLIC HEALTH SERVICE ACT 1336
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p.001335: (c) RELIGIOUS CHARACTER AND INDEPENDENCE.—
p.001335: (1) IN GENERAL.—A religious organization that provides services under any substance abuse program under this
p.001335: title or title V shall retain its independence from Federal, State, and local governments, including such
p.001335: organization’s control over the definition, development, practice, and expression of its reli- gious beliefs.
p.001335: (2) ADDITIONAL SAFEGUARDS.—Neither the Federal Govern- ment nor a State or local government shall require a religious
p.001335: organization—
p.001335: (A) to alter its form of internal governance; or
p.001335: (B) to remove religious art, icons, scripture, or other symbols,
p.001335: in order to be eligible to provide services under any substance abuse program under this title or title V.
p.001335: (d) EMPLOYMENT PRACTICES.—
p.001335: (1) SUBSTANCE ABUSE.—A religious organization that pro- vides services under any substance abuse program
p.001335: under this title or title V may require that its employees providing serv- ices under such program
p.001335: adhere to rules forbidding the use of drugs or alcohol.
p.001335: (2) TITLE VII EXEMPTION.—The exemption of a religious or- ganization provided under section 702 or 703(e)(2) of the
p.001335: Civil Rights Act of 1964 (42 U.S.C. 2000e–1, 2000e–2(e)(2)) regard- ing employment practices shall not be
p.001335: affected by the religious organization’s provision of services under, or receipt of funds from, any substance
p.001335: abuse program under this title or title V.
p.001335: (e) RIGHTS OF BENEFICIARIES OF ASSISTANCE.—
p.001335: (1) IN GENERAL.—If an individual described in paragraph
p.001335: (3) has an objection to the religious character of the organiza- tion from which the individual receives, or
p.001335: would receive, serv- ices funded under any substance abuse program under this title or title V, the appropriate
p.001335: Federal, State, or local govern- mental entity shall provide to such individual (if otherwise eli- gible for such
p.001335: services) within a reasonable period of time after the date of such objection, services that—
p.001335: (A) are from an alternative provider that is accessible to the individual; and
p.001335: (B) have a value that is not less than the value of the services that the individual would have received from such
p.001335: organization.
p.001335: (2) NOTICE.—The appropriate Federal, State, or local gov- ernmental entity shall ensure that notice is
p.001335: provided to indi- viduals described in paragraph (3) of the rights of such individ- uals under this section.
p.001335: (3) INDIVIDUAL DESCRIBED.—An individual described in this paragraph is an individual who receives or
p.001335: applies for services under any substance abuse program under this title or title V.
p.001335: (f) NONDISCRIMINATION AGAINST BENEFICIARIES.—A religious organization providing services through a grant,
p.001335: contract, or coop- erative agreement under any substance abuse program under this title or title V shall not
p.001335: discriminate, in carrying out such program, against an individual described in subsection (e)(3) on the basis of
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: 1337
p.001337: PUBLIC HEALTH SERVICE ACT
p.001337: Sec. 1957
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p.001337: religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in
p.001337: a religious practice.
p.001337: (g) FISCAL ACCOUNTABILITY.—
p.001337: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization providing services under any
p.001337: substance abuse program under this title or title V shall be subject to the same regulations as other
p.001337: nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such
p.001337: funds provided under such program.
p.001337: (2) LIMITED AUDIT.—Such organization shall segregate gov- ernment funds provided under such substance abuse
p.001337: program into a separate account. Only the government funds shall be subject to audit by the government.
p.001337: (h) COMPLIANCE.—Any party that seeks to enforce such party’s rights under this section may assert a civil action for
p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
p.001337: religious organiza- tion to provide services under any substance abuse program under this title or title V shall be
p.001337: expended for sectarian worship, instruc- tion, or proselytization.
p.001337: (j) EFFECT ON STATE AND LOCAL FUNDS.—If a State or local government contributes State or local funds to
p.001337: carry out any sub- stance abuse program under this title or title V, the State or local government may segregate
p.001337: the State or local funds from the Fed- eral funds provided to carry out the program or may commingle the State
p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
p.001337: SEC. 1956. ø300x–66¿ SERVICES FOR INDIVIDUALS WITH CO-OCCUR- RING DISORDERS.
p.001337: States may use funds available for treatment under sections 1911 and 1921 to treat persons with
p.001337: co-occurring substance abuse and mental disorders as long as funds available under such sec- tions are
p.001337: used for the purposes for which they were authorized by law and can be tracked for accounting purposes.
p.001337: SEC. 1957. ø300x-67¿ PUBLIC HEALTH EMERGENCIES.
p.001337: In the case of a public health emergency (as determined under section 319), the Secretary, on a State by State basis,
p.001337: may, as the circumstances of the emergency reasonably require and for the pe-
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: Sec. 1958 PUBLIC HEALTH SERVICE ACT 1338
p.001337:
p.001337: riod of the emergency, grant an extension, or waive application deadlines or compliance with any other
p.001337: requirement, of a grant au- thorized under section 521, 1911, or 1921 or an allotment author- ized under
p.001337: Public Law 99–319 (42 U.S.C. 10801 et seq.).
p.001337: SEC. 1958. ø300x-68¿ JOINT APPLICATIONS.
p.001337: The Secretary, acting through the Assistant Secretary for Men- tal Health and Substance Use, shall permit a
p.001337: joint application to be submitted for grants under subpart I and subpart II upon the request of a
p.001337: State. Such application may be jointly reviewed and approved by the Secretary with respect to such subparts,
p.001337: consistent with the purposes and authorized activities of each such grant pro- gram. A State submitting such a
p.001337: joint application shall otherwise meet the requirements with respect to each such subpart.
p.001337:
p.001337: PART C—CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE
p.001337: Subpart I—Data Infrastructure Development
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p.001337: SEC. 1971. ø300y¿ DATA INFRASTRUCTURE DEVELOPMENT.
p.001337: (a) IN GENERAL.—The Secretary may make grants to, and enter into contracts or cooperative agreements with
p.001337: States for the purpose of developing and operating mental health or substance abuse data collection,
p.001337: analysis, and reporting systems with regard to performance measures including capacity, process, and outcomes
p.001337: measures.
p.001337: (b) PROJECTS.—The Secretary shall establish criteria to ensure that services will be available under this
p.001337: section to States that have a fundamental basis for the collection, analysis, and reporting of mental health and
p.001337: substance abuse performance measures and States that do not have such basis. The Secretary will establish cri-
p.001337: teria for determining whether a State has a fundamental basis for the collection, analysis, and reporting of data.
p.001337: (c) CONDITION OF RECEIPT OF FUNDS.—As a condition of the re- ceipt of an award under this section a State
p.001337: shall agree to collect, analyze, and report to the Secretary within 2 years of the date of the award on
p.001337: a core set of performance measures to be determined by the Secretary in conjunction with the States.
p.001337: (d) MATCHING REQUIREMENT.—
p.001337: (1) IN GENERAL.—With respect to the costs of the program to be carried out under subsection (a) by a State, the
p.001337: Secretary may make an award under such subsection only if the appli- cant agrees to make available
p.001337: (directly or through donations from public or private entities) non-Federal contributions to- ward such costs
p.001337: in an amount that is not less than 50 percent of such costs.
p.001337: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001337: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001337: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001337: not be included in determining the amount of such contributions.
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001339: 1339
p.001339: PUBLIC HEALTH SERVICE ACT
p.001339: Sec. 1976
p.001339:
p.001339: (e) DURATION OF SUPPORT.—The period during which payments may be made for a project under subsection (a) may
p.001339: be not less than 3 years nor more than 5 years.
p.001339: (f) AUTHORIZATION OF APPROPRIATION.—
p.001339: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated such
p.001339: sums as may be necessary for each of the fiscal years 2001, 2002 and 2003.
p.001339: (2) ALLOCATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall
p.001339: be expended to support data infrastructure development for mental health and 50 percent shall be expended
p.001339: to support data infrastruc- ture development for substance abuse.
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p.001339: Subpart II—Interim Maintenance Treatment of Narcotics Dependence
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p.001339: SEC. 1976. ø300y–11¿ INTERIM MAINTENANCE TREATMENT.
p.001339: (a) REQUIREMENT REGARDING SECRETARY.—Subject to the fol- lowing subsections of this section, for the
p.001339: purpose of reducing the incidence of the transmission of HIV disease pursuant to the intra- venous abuse of heroin
p.001339: or other morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or
p.001339: nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs—
p.001339: (1) to dispense methadone for treatment purposes to indi- viduals who—
p.001339: (A) meet the conditions for admission to such pro- grams that dispense methadone as part of
p.001339: comprehensive treatment for such dependence; and
p.001339: (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity
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p.001395: Administrator of General Services, as
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p.001395: 2 Designations are so in law. Subparagraphs (A) and (B) should probably be designated para- graphs (1) and (2),
p.001395: respectively. Similarly, clauses (i) and (ii) of subparagraph (B) should prob- ably be designated
p.001395: subparagraphs (A) and (B), respectively.
p.001395: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001397: the case may be, does not disapprove a priority request during the 21-day period, the request shall be deemed to be
p.001397: approved.
p.001397: (b) NOTICE TO SECRETARY AND TO ASSISTANT SECRETARY FOR HEALTH.—The Administrator of the Substance Abuse
p.001397: and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention,
p.001397: the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall, respectively,
p.001397: transmit to the Secretary and the Assistant Secretary for Health a copy of each priority request made under this
p.001397: section by the agency head involved. The copy shall be transmitted on the date on which the priority request involved
p.001397: is made.
p.001397: (c) DEFINITION OF PRIORITY REQUEST.—For purposes of this section, the term ‘‘priority request’’ means any
p.001397: request that—
p.001397: (1) is designated as a priority request by the Administrator of the Substance Abuse and Mental Health Services
p.001397: Adminis- tration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and
p.001397: Drugs, or the Direc- tor of the National Institutes of Health; and
p.001397: (2)(A) is made to the Director of the Office of Personnel Management for the allocation of personnel to carry
p.001397: out activi- ties with respect to acquired immune deficiency syndrome; or
p.001397: (B) is made to the Administrator of General Services for administrative support or space in carrying out such
p.001397: activities.
p.001397: SEC. 2304. ø300cc–3¿ ESTABLISHMENT OF RESEARCH ADVISORY COM- MITTEE.
p.001397: (a) IN GENERAL.—After consultation with the Commissioner of Food and Drugs, the Secretary, acting through the
p.001397: Director of the National Institute of Allergy and Infectious Diseases, shall estab- lish within such
p.001397: Institute an advisory committee to be known as the AIDS Research Advisory Committee (hereafter in this
p.001397: section referred to as the ‘‘Committee’’).
p.001397: (b) COMPOSITION.—The Committee shall be composed of physi- cians whose clinical practice includes a significant
p.001397: number of pa- tients with acquired immune deficiency syndrome.
p.001397: (c) DUTIES.—The Committee shall—
p.001397: (1) advise the Director of such Institute (and may provide advice to the Directors of other agencies of the
p.001397: National Insti- tutes of Health, as appropriate) on appropriate research activi- ties to be undertaken with respect to
p.001397: clinical treatment of such syndrome, including advice with respect to—
p.001397: (A) research on drugs for preventing or minimizing the development of symptoms or conditions arising from infec- tion
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p.001429: (4) the availability in the geographic area of any appro- priate services with respect to health care,
p.001429: including mental health care and social and support services;
p.001429: (5) the benefits of locating and counseling any individual by whom the infected individual may have been
p.001429: exposed to the etiologic agent for acquired immune deficiency syndrome and any individual whom the infected
p.001429: individual may have exposed to such etiologic agent; and
p.001429: (6) the availability, if any, of the services of public health authorities with respect to locating and
p.001429: counseling any indi- vidual described in paragraph (5).
p.001429: (d) RULE OF CONSTRUCTION WITH RESPECT TO COUNSELING WITHOUT TESTING.—Agreements entered into
p.001429: pursuant to sub- sections (a) through (c) may not be construed to prohibit any grant- ee under section 2431 from
p.001429: expending the grant for the purpose of providing counseling services described in such subsections to an
p.001429: individual who will not undergo testing described in such section as a result of the grantee or the
p.001429: individual determining that such testing of the individual is not appropriate.
p.001429: (e) USE OF FUNDS.—
p.001429: (1) The purpose of this subpart 4 is to provide for coun- seling and testing services to prevent and
p.001429: reduce exposure to, and transmission of, the etiologic agent for acquired immune deficiency syndrome.
p.001429: (2) All individuals receiving counseling pursuant to this subpart 4 are to be counseled about the harmful
p.001429: effects of pro- miscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such
p.001429: activities.
p.001429: (3) None of the fund appropriated to carry out this sub- part 4 may be used to provide counseling
p.001429: that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous
p.001429: drug abuse.
p.001429: (4) Paragraph (3) may not be construed to prohibit a coun- selor who has already performed the counseling of an
p.001429: indi- vidual required by paragraph (2), to provide accurate informa- tion about means to reduce an individual’s risk
p.001429: of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
p.001429: informational materials used are not obscene.
p.001429: SEC. 2433. ø300dd–33¿ FUNDING.
p.001429: For the purpose of grants under section 2431, there are author- ized to be appropriated $100,000,000 for each of
p.001429: the fiscal years 1989 and 1990.
p.001429:
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p.001429:
p.001429: January 30, 2020
p.001429: 4 Probably should be ‘‘part’’. See section 118(b)(1)(B) of Public Law 102–321 (106 Stat. 348).
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001431: 1431
p.001431: PUBLIC HEALTH SERVICE ACT
p.001431: Sec. 2502
p.001431:
p.001431: TITLE XXV—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001431: SEC. 2500. ø300ee¿ USE OF FUNDS.
p.001431: (a) IN GENERAL.—The purpose of this title is to provide for the establishment of education and information
p.001431: programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune
p.001431: deficiency syndrome.
p.001431: (b) CONTENTS OF PROGRAMS.—All programs of education and information receiving funds under this title shall
p.001431: include informa- tion about the harmful effects of promiscuous sexual activity and intravenous substance
p.001431: abuse, and the benefits of abstaining from such activities.
p.001431: (c) LIMITATION.—None of the funds appropriated to carry out this title may be used to provide education or
p.001431: information designed to promote or encourage, directly, homosexual or heterosexual sex- ual activity or intravenous
p.001431: substance abuse.
p.001431: (d) CONSTRUCTION.—Subsection (c) may not be construed to re- strict the ability of an education program that
p.001431: includes the infor- mation required in subsection (b) to provide accurate information about various means
p.001431: to reduce an individual’s risk of exposure to, or the transmission of, the etiologic agent for acquired immune
p.001431: de- ficiency syndrome, provided that any informational materials used are not obscene.
p.001431: PART A—FORMULA GRANTS TO STATES
p.001431: SEC. 2501. ø300ee–11¿ ESTABLISHMENT OF PROGRAM.
p.001431: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001431: fiscal years 1989 through 1991 make an allotment for each State in an amount de- termined in accordance
p.001431: with section 2507. The Secretary shall make payments each such fiscal year to each State from the allot- ment for
p.001431: the State if the Secretary approves for the fiscal year in- volved an application submitted by the State
p.001431: pursuant to section 2503.
p.001431: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001431: unless the State in- volved agrees to expend the payments only for the purpose of car- rying out, in
p.001431: accordance with section 2502, public information ac- tivities with respect to acquired immune deficiency
p.001431: syndrome.
p.001431: SEC. 2502. ø300ee–12¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.001431: A State may expend payments received under section 2501(a)—
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p.001433: unless the State involved agrees to make copies of the reports and audits described in this section available for
p.001433: public inspection.
p.001433: (d) EVALUATIONS BY COMPTROLLER GENERAL.—The Comp- troller General of the United States shall, from time to
p.001433: time, evalu- ate the expenditures by States of payments received under section 2501(a) in order to ensure that
p.001433: expenditures are consistent with the provisions of this part.
p.001433: SEC. 2506. ø300ee–16¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001433: (a) IN GENERAL.—The Secretary may not, except as provided in subsection (b), make payments under section 2501(a)
p.001433: for a fiscal year unless the State involved agrees that—
p.001433: (1) all programs conducted or supported by the State with such payments will establish objectives for the
p.001433: program and will determine the extent to which the objectives are met;
p.001433: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001433:
p.001433:
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p.001433:
p.001435: 1435
p.001435: PUBLIC HEALTH SERVICE ACT
p.001435: Sec. 2506
p.001435:
p.001435: (2) information provided under this part will be scientif- ically accurate and factually correct;
p.001435: (3) in carrying out section 2501(b), the State will give pri- ority to programs described in section 2502(10) for
p.001435: individuals described in such section;
p.001435: (4) with respect to a State in which there is a substantial number of individuals who are intravenous substance
p.001435: abusers, the State will place priority on activities under this part di- rected at such substance abusers;
p.001435: (5) with respect to a State in which there is a significant incidence of reported cases of acquired immune
p.001435: deficiency syn- drome, the State will—
p.001435: (A) for the purpose described in subsection (b) of sec- tion 2501, expend not less than 50 percent of payments
p.001435: re- ceived under subsection (a) of such section for a fiscal year—
p.001435: (i) to make grants to public entities, to migrant health centers (as defined in section 329(a)), to
p.001435: com- munity health centers (as defined in section 330(a)) 3, and to nonprofit private entities concerned
p.001435: with ac- quired immune deficiency syndrome; or
p.001435: (ii) to enter into contracts with public and private entities; and
p.001435: (B) of the amounts reserved for a fiscal year by the State for expenditures required in subparagraph
p.001435: (A), ex- pend not less than 50 percent to carry out section 2502(10) through grants to nonprofit private
p.001435: entities, including mi- nority entities, concerned with acquired immune deficiency syndrome located in and
p.001435: representative of communities and subpopulations reflecting the local incidence of such syndrome;
p.001435: (6) with respect to programs carried out pursuant to sec- tion 2502(10), the State will ensure that any
p.001435: applicant for a grant under such section agrees—
p.001435: (A) that any educational or informational materials developed with a grant pursuant to such section will
p.001435: con- tain material, and be presented in a manner, that is spe- cifically directed toward the group for
p.001435: which such mate- rials are intended;
...

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p.001443: January 30, 2020
p.001443:
p.001443: (1) ESTABLISHMENT.—To be eligible for assistance under this subpart, the chief elected official described
p.001443: in subsection (a)(1) shall establish or designate an HIV health services plan- ning council that shall reflect in
p.001443: its composition the demo- graphics of the population of individuals with HIV/AIDS in the eligible area involved,
p.001443: with particular consideration given to disproportionately affected and historically underserved groups and
p.001443: subpopulations. Nominations for membership on the coun- cil shall be identified through an open process and
p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
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p.001445: (i) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services;
p.001445: (ii) disparities in access and services among af- fected subpopulations and historically underserved
p.001445: communities; and
p.001445: (iii) individuals with HIV/AIDS who do not know their HIV status;
p.001445: (C) establish priorities for the allocation of funds with- in the eligible area, including how best to meet each such
p.001445: priority and additional factors that a grantee should con- sider in allocating funds under a grant based on
p.001445: the—
p.001445: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under subpara- graph (A)) and
p.001445: the needs of such population (as deter- mined under subparagraph (B));
p.001445: (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and
p.001445: interventions, to the extent that data are reasonably available;
p.001445: (iii) priorities of the communities with HIV/AIDS for whom the services are intended;
p.001445: (iv) coordination in the provision of services to such individuals with programs for HIV prevention and
p.001445: for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for
p.001445: such abuse;
p.001445: (v) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001445: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001445: Act to cover health care costs of eligible individuals and families with HIV/AIDS; and
p.001445: (vi) capacity development needs resulting from disparities in the availability of HIV-related services
p.001445: in historically underserved communities;
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001445:
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p.001445: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1446
p.001445:
p.001445: (D) develop a comprehensive plan for the organization and delivery of health and support services described in
p.001445: section 2604 that—
p.001445: (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services
p.001445: and for informing the individuals of and ena- bling the individuals to utilize the services, giving par- ticular
p.001445: attention to eliminating disparities in access and services among affected subpopulations and his- torically
p.001445: underserved communities, and including dis- crete goals, a timetable, and an appropriate allocation of funds;
p.001445: (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (in- cluding
p.001445: outreach and early intervention) and for the prevention and treatment of substance abuse (includ- ing
p.001445: programs that provide comprehensive treatment services for such abuse);
p.001445: (iii) is compatible with any State or local plan for the provision of services to individuals with HIV/AIDS; and
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p.001445: January 30, 2020
p.001445: (iv) includes a strategy, coordinated as appro- priate with other community strategies and efforts, in-
p.001445: cluding discrete goals, a timetable, and appropriate funding, for identifying individuals with HIV/AIDS
p.001445: who do not know their HIV status, making such indi- viduals aware of such status, and enabling such indi-
p.001445: viduals to use the health and support services de- scribed in section 2604, with particular attention to re-
p.001445: ducing barriers to routine testing and disparities in access and services among affected subpopulations and
p.001445: historically underserved communities;
p.001445: (E) assess the efficiency of the administrative mecha- nism in rapidly allocating funds to the areas of
p.001445: greatest need within the eligible area, and at the discretion of the planning council, assess the
...

p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
p.001459:
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p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001459:
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p.001461: 1461
p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
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p.001463: January 30, 2020
p.001463:
p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
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p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
p.001473:
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p.001473:
p.001473:
p.001473:
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p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001473:
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p.001473: Sec. 2612 PUBLIC HEALTH SERVICE ACT 1474
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p.001473: January 30, 2020
p.001473:
p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
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p.001475: title XXI of such Act, or other Federal or State programs.
p.001475: (f) CONSTRUCTION.—A State may not use amounts received under a grant awarded under section 2611 to purchase or
p.001475: improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or
p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
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p.001481: (ii) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001481: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001481: Act to cover health care costs of eligible individuals and families with HIV/AIDS;
p.001481: (iii) capacity development needs resulting from disparities in the availability of HIV-related services
p.001481: in historically underserved communities and rural communities; and
p.001481: (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of
p.001481: greatest need within the State;
p.001481: (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and
p.001481: for informing the individuals of and enabling the indi- viduals to utilize the services, giving particular
p.001481: attention to eliminating disparities in access and services among af- fected subpopulations and historically
p.001481: underserved commu- nities, and including discrete goals, a timetable, and an ap- propriate allocation of funds;
p.001481: (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention
p.001481: (including outreach and early intervention) and for the prevention and treatment of substance abuse
p.001481: (including programs that provide comprehensive treatment services for such abuse);
p.001481: (D) describes the services and activities to be provided and an explanation of the manner in which the
p.001481: elements of the program to be implemented by the State with such assistance will maximize the quality of
p.001481: health and support services available to individuals with HIV/AIDS through- out the State;
p.001481: (E) provides a description of the manner in which services funded with assistance provided under section
p.001481: 2611 will be coordinated with other available related serv- ices for individuals with HIV/AIDS;
p.001481: (F) provides a description of how the allocation and utilization of resources are consistent with the
p.001481: statewide coordinated statement of need (including traditionally un- derserved populations and subpopulations)
p.001481: developed in
p.001481:
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p.001481:
p.001481:
p.001481: January 30, 2020
p.001481: 7 The placement of subparagraphs (A) through (C) is according to the probable intent of the Congress.
p.001481: Section 205(a)(3) of Public Law 106–345 (114 Stat. 1332, 1333) amended paragraph
p.001481: (4) by redesignating subparagraphs (A) through (C) as subparagraphs (D) through (F), and then instructed that new
p.001481: subparagraphs (A) through (C) be inserted before ‘‘subparagraph (C)’’. The amendment probably should have
p.001481: instructed that the new subparagraphs be inserted before sub- paragraph (D), as redesignated.
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p.001483:
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p.001483:
p.001483:
p.001483: January 30, 2020
p.001483:
p.001483: health and support services provided by entities that re- ceive funds from the State under section 2611;
p.001483: (D) the State will permit and cooperate with any Fed- eral investigations undertaken regarding programs con-
p.001483: ducted under section 2611;
p.001483: (E) the State will maintain HIV-related activities at a level that is equal to not less than the level of
p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
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p.001501: January 30, 2020
p.001501:
p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
p.001501: (g) DEFINITIONS.—In this section:
p.001501: (1) The term ‘‘voluntary opt-out testing’’ means HIV/AIDS testing—
p.001501: (A) that is administered to an individual seeking other health care services; and
p.001501: (B) in which—
...

p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
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p.001507: January 30, 2020
p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
p.001507: (A) counseling individuals with respect to HIV/AIDS in accordance with section 2662;
p.001507: (B) testing individuals with respect to HIV/AIDS, in- cluding tests to confirm the presence of the
p.001507: disease, tests to diagnose the extent of the deficiency in the immune sys-
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001507:
p.001507:
p.001507:
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p.001507:
p.001507:
p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001519: 1519
p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
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p.001519: unrelated to services or indirect costs.
p.001519: (2) INDIRECT COSTS.—The term ‘‘indirect costs’’ means costs included in a Federally negotiated indirect rate.
p.001519: (3) SERVICES.—The term ‘‘services’’ means—
p.001519: (A) services that are provided to clients to meet the goals and objectives of the program under this section,
p.001519: in- cluding the provision of professional, diagnostic, and thera- peutic services by a primary care provider or a
p.001519: referral to and provision of specialty care; and
p.001519: (B) services that sustain program activity and con- tribute to or help improve services under
p.001519: subparagraph (A).
p.001519: (i) APPLICATION TO PRIMARY CARE SERVICES.—Nothing in this part shall be construed as requiring funds
p.001519: under this part to be used for primary care services when payments are available for such services from
p.001519: other sources (including under titles XVIII, XIX, and XXI of the Social Security Act).
p.001519: (j) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001519: to be appropriated,
p.001519: $71,800,000 for each of the fiscal years 2007 through 2009,
p.001519: $75,390,000 for fiscal year 2010, $79,160,000 for fiscal year 2011,
p.001519: $83,117,000 for fiscal year 2012, and $87,273,000 for fiscal year 2013.
p.001519:
p.001519: PART E—GENERAL PROVISIONS
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p.001519: January 30, 2020
p.001519: SEC. 2681. ø300ff–81¿ COORDINATION.
p.001519: (a) REQUIREMENT.—The Secretary shall ensure that the Health Resources and Services Administration, the Centers
p.001519: for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the
p.001519: Centers for Medicare & Medicaid Services coordinate the planning, funding, and implementation of Federal HIV
p.001519: programs (including all minority AIDS initiatives of
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001521: PUBLIC HEALTH SERVICE ACT
p.001521: Sec. 2683
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p.001521: January 30, 2020
p.001521: the Public Health Service, including under section 2693) to enhance the continuity of care and prevention
p.001521: services for individuals with HIV/AIDS or those at risk of such disease. The Secretary shall con- sult with other
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p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
p.001521: include a history of program activities within each relevant agency and a description of activi- ties
p.001521: conducted, people served and types of grantees funded, and shall collect and describe best practices in
p.001521: community outreach and capacity-building of community based organizations serving the communities that are
p.001521: disproportionately affected by HIV/AIDS.
p.001521: SEC. 2687. ø300ff–87¿ SEVERITY OF NEED INDEX.
p.001521: (a) DEVELOPMENT OF INDEX.—Not later than September 30, 2008, the Secretary shall develop and submit to
p.001521: the appropriate
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001523: PUBLIC HEALTH SERVICE ACT
p.001523: Sec. 2688
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p.001575: (1) IN GENERAL.—The requirements of this section shall not apply with respect to health insurance coverage if
p.001575: there is a State law (as defined in section 2723(d)(1)) for a State that regulates such coverage that is
p.001575: described in any of the fol- lowing subparagraphs:
p.001575: (A) Such State law requires such coverage to provide for at least a 48-hour hospital length of stay
p.001575: following a normal vaginal delivery and at least a 96-hour hospital length of stay following a cesarean
p.001575: section.
p.001575: (B) Such State law requires such coverage to provide for maternity and pediatric care in accordance with guide-
p.001575: lines established by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or
p.001575: other established professional medical associations.
p.001575: (C) Such State law requires, in connection with such coverage for maternity care, that the hospital
p.001575: length of stay for such care is left to the decision of (or required to be made by) the attending
p.001575: provider in consultation with the mother.
p.001575: (2) CONSTRUCTION.—Section 2723(a)(1) shall not be con- strued as superseding a State law described in
p.001575: paragraph (1).
p.001575: SEC. 2726. ø300gg–26¿ PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS.
p.001575: (a) IN GENERAL.—
p.001575: (1) AGGREGATE LIFETIME LIMITS.—In the case of a group health plan or a health insurance issuer offering group
p.001575: or indi- vidual health insurance coverage that provides both medical and surgical benefits and mental
p.001575: health or substance use dis- order benefits—
p.001575: (A) NO LIFETIME LIMIT.—If the plan or coverage does not include an aggregate lifetime limit on substantially
p.001575: all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on
p.001575: mental health or substance use disorder benefits.
p.001575: (B) LIFETIME LIMIT.—If the plan or coverage includes an aggregate lifetime limit on substantially all
p.001575: medical and surgical benefits (in this paragraph referred to as the ‘‘applicable lifetime limit’’), the plan or
p.001575: coverage shall ei- ther—
p.001575:
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p.001575:
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p.001575: January 30, 2020
p.001575: (i) apply the applicable lifetime limit both to the medical and surgical benefits to which it otherwise
p.001575: would apply and to mental health and substance use
p.001575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001575: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1576
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p.001575: disorder benefits and not distinguish in the applica- tion of such limit between such medical and
p.001575: surgical benefits and mental health and substance use disorder benefits; or
p.001575: (ii) not include any aggregate lifetime limit on mental health or substance use disorder benefits that is
p.001575: less than the applicable lifetime limit.
p.001575: (C) RULE IN CASE OF DIFFERENT LIMITS.—In the case of a plan or coverage that is not described in subparagraph
p.001575: (A) or (B) and that includes no or different aggregate life- time limits on different categories of medical and
p.001575: surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or
p.001575: coverage with respect to mental health and substance use disorder bene- fits by substituting for the applicable
p.001575: lifetime limit an av- erage aggregate lifetime limit that
p.001575: is computed taking into account the weighted average of the aggregate lifetime limits applicable to such
p.001575: categories.
p.001575: (2) ANNUAL LIMITS.—In the case of a group health plan or a health insurance issuer offering group or
p.001575: individual health insurance coverage that provides both medical and surgical benefits and mental health or
p.001575: substance use disorder bene- fits—
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p.001575: January 30, 2020
p.001575: (A) NO ANNUAL LIMIT.—If the plan or coverage does not include an annual limit on substantially all
p.001575: medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health or
p.001575: substance use dis- order benefits.
p.001575: (B) ANNUAL LIMIT.—If the plan or coverage includes an annual limit on substantially all medical and
p.001575: surgical benefits (in this paragraph referred to as the ‘‘applicable annual limit’’), the plan or coverage
p.001575: shall either—
p.001575: (i) apply the applicable annual limit both to med- ical and surgical benefits to which it otherwise would apply
p.001575: and to mental health and substance use disorder benefits and not distinguish in the application of such limit between
p.001575: such medical and surgical benefits and mental health and substance use disorder benefits; or
p.001575: (ii) not include any annual limit on mental health or substance use disorder benefits that is less than the applicable
p.001575: annual limit.
p.001575: (C) RULE IN CASE OF DIFFERENT LIMITS.—In the case of a plan or coverage that is not described in subparagraph
p.001575: (A) or (B) and that includes no or different annual limits on different categories of medical and surgical
p.001575: benefits, the Secretary shall establish rules under which subparagraph
p.001575: (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by
p.001575: sub- stituting for the applicable annual limit an average annual limit that is computed taking into account the
p.001575: weighted average of the annual limits applicable to such categories.
p.001575: (3) FINANCIAL REQUIREMENTS AND TREATMENT LIMITA- TIONS.—
p.001575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001577: 1577
p.001577: PUBLIC HEALTH SERVICE ACT
p.001577: Sec. 2726
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p.001577: January 30, 2020
p.001577: (A) IN GENERAL.—In the case of a group health plan or a health insurance issuer offering group or
p.001577: individual health insurance coverage that provides both medical and surgical benefits and mental health or
p.001577: substance use dis- order benefits, such plan or coverage shall ensure that—
p.001577: (i) the financial requirements applicable to such mental health or substance use disorder benefits are no
p.001577: more restrictive than the predominant financial re- quirements applied to substantially all medical and surgical
p.001577: benefits covered by the plan (or coverage), and there are no separate cost sharing requirements that are
p.001577: applicable only with respect to mental health or substance use disorder benefits; and
p.001577: (ii) the treatment limitations applicable to such mental health or substance use disorder benefits are no
p.001577: more restrictive than the predominant treatment limitations applied to substantially all medical and
p.001577: surgical benefits covered by the plan (or coverage) and there are no separate treatment limitations that are
p.001577: applicable only with respect to mental health or sub- stance use disorder benefits.
p.001577: (B) DEFINITIONS.—In this paragraph:
p.001577: (i) FINANCIAL REQUIREMENT.—The term ‘‘financial requirement’’ includes deductibles, copayments, coin- surance,
p.001577: and out-of-pocket expenses, but excludes an aggregate lifetime limit and an annual limit subject to paragraphs (1)
p.001577: and (2).
p.001577: (ii) PREDOMINANT.—A financial requirement or treatment limit is considered to be predominant if it is
p.001577: the most common or frequent of such type of limit or requirement.
p.001577: (iii) TREATMENT LIMITATION.—The term ‘‘treat- ment limitation’’ includes limits on the frequency of
p.001577: treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment.
p.001577: (4) AVAILABILITY OF PLAN INFORMATION.—The criteria for medical necessity determinations made under the plan with
p.001577: re- spect to mental health or substance use disorder benefits (or the health insurance coverage offered
p.001577: in connection with the plan with respect to such benefits) shall be made available by the plan
p.001577: administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or
p.001577: potential participant, beneficiary, or contracting provider upon request. The reason for any denial under the plan (or
p.001577: coverage) of reimbursement or payment for services with respect to men- tal health or substance use disorder benefits
p.001577: in the case of any participant or beneficiary shall, on request or as otherwise re- quired, be made available by
p.001577: the plan administrator (or the health insurance issuer offering such coverage) to the partici- pant or
p.001577: beneficiary in accordance with regulations.
p.001577: (5) OUT-OF-NETWORK PROVIDERS.—In the case of a plan or coverage that provides both medical and surgical
p.001577: benefits and mental health or substance use disorder benefits, if the plan or coverage provides coverage for medical
p.001577: or surgical benefits pro-
p.001577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001577: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1578
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p.001577: January 30, 2020
p.001577:
p.001577: vided by out-of-network providers, the plan or coverage shall provide coverage for mental health or
p.001577: substance use disorder benefits provided by out-of-network providers in a manner that is consistent with the
p.001577: requirements of this section.
p.001577: (6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—
p.001577: (A) IN GENERAL.—Not later than 12 months after the date of enactment of the Helping Families in
p.001577: Mental Health Crisis Reform Act of 2016, the Secretary, the Sec- retary of Labor, and the Secretary of the
p.001577: Treasury, in con- sultation with the Inspector General of the Department of Health and Human Services, the
p.001577: Inspector General of the Department of Labor, and the Inspector General of the De- partment of the Treasury,
p.001577: shall issue a compliance pro- gram guidance document to help improve compliance with this section, section 712
p.001577: of the Employee Retirement In- come Security Act of 1974, and section 9812 of the Internal Revenue Code of 1986,
p.001577: as applicable. In carrying out this paragraph, the Secretaries may take into consideration the 2016 publication
p.001577: of the Department of Health and Human Services and the Department of Labor, entitled ‘‘Warning Signs - Plan or
p.001577: Policy Non-Quantitative Treatment Limita- tions (NQTLs) that Require Additional Analysis to Deter- mine Mental
p.001577: Health Parity Compliance’’.
p.001577: (B) EXAMPLES ILLUSTRATING COMPLIANCE AND NON- COMPLIANCE.—
p.001577: (i) IN GENERAL.—The compliance program guid- ance document required under this paragraph shall provide
p.001577: illustrative, de-identified examples (that do not disclose any protected health information or indi-
p.001577: vidually identifiable information) of previous findings of compliance and noncompliance with this section,
p.001577: section 712 of the Employee Retirement Income Secu- rity Act of 1974, or section 9812 of the Internal Rev-
p.001577: enue Code of 1986, as applicable, based on investiga- tions of violations of such sections, including—
p.001577: (I) examples illustrating requirements for in- formation disclosures and nonquantitative treat- ment
p.001577: limitations; and
p.001577: (II) descriptions of the violations uncovered during the course of such investigations.
p.001577: (ii) NONQUANTITATIVE TREATMENT LIMITATIONS.— To the extent that any example described in clause (i) involves a
p.001577: finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment
p.001577: limitations, the example shall provide suffi- cient detail to fully explain such finding, including a full
p.001577: description of the criteria involved for approving medical and surgical benefits and the criteria involved for
p.001577: approving mental health and substance use dis- order benefits.
p.001577: (iii) ACCESS TO ADDITIONAL INFORMATION REGARD- ING COMPLIANCE.—In developing and issuing the com- pliance
p.001577: program guidance document required under
p.001577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001579: 1579
p.001579: PUBLIC HEALTH SERVICE ACT
p.001579: Sec. 2726
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p.001579: January 30, 2020
p.001579: this paragraph, the Secretaries specified in subpara- graph (A)—
p.001579: (I) shall enter into interagency agreements with the Inspector General of the Department of Health and
p.001579: Human Services, the Inspector Gen- eral of the Department of Labor, and the Inspec- tor General of the
p.001579: Department of the Treasury to share findings of compliance and noncompliance with this section, section 712 of
p.001579: the Employee Re- tirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as
p.001579: ap- plicable; and
p.001579: (II) shall seek to enter into an agreement with a State to share information on findings of compli- ance and
p.001579: noncompliance with this section, section 712 of the Employee Retirement Income Security Act of 1974, or
p.001579: section 9812 of the Internal Rev- enue Code of 1986, as applicable.
p.001579: (C) RECOMMENDATIONS.—The compliance program guidance document shall include recommendations to ad- vance
p.001579: compliance with this section, section 712 of the Em- ployee Retirement Income Security Act of 1974, or section 9812 of
p.001579: the Internal Revenue Code of 1986, as applicable, and encourage the development and use of internal
p.001579: con- trols to monitor adherence to applicable statutes, regula- tions, and program requirements. Such
p.001579: internal controls may include illustrative examples of nonquantitative treat- ment limitations on mental health
p.001579: and substance use dis- order benefits, which may fail to comply with this section, section 712 of the Employee
p.001579: Retirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, in
p.001579: relation to nonquantitative treat- ment limitations on medical and surgical benefits.
p.001579: (D) UPDATING THE COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—The Secretary, the Secretary of Labor, and the
p.001579: Secretary of the Treasury, in consultation with the In- spector General of the Department of Health and Human
p.001579: Services, the Inspector General of the Department of Labor, and the Inspector General of the Department
p.001579: of the Treasury, shall update the compliance program guidance document every 2 years to include
p.001579: illustrative, de-identi- fied examples (that do not disclose any protected health in- formation or individually
p.001579: identifiable information) of pre- vious findings of compliance and noncompliance with this section, section
p.001579: 712 of the Employee Retirement Income Security Act of 1974, or section 9812 of the Internal Rev- enue
p.001579: Code of 1986, as applicable.
p.001579: (7) ADDITIONAL GUIDANCE.—
p.001579: (A) IN GENERAL.—Not later than 12 months after the date of enactment of the Helping Families in
p.001579: Mental Health Crisis Reform Act of 2016, the Secretary, the Sec- retary of Labor, and the Secretary of
p.001579: the Treasury shall issue guidance to group health plans and health insurance issuers offering group or individual
p.001579: health insurance cov-
p.001579: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001579:
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p.001579: sections, as applicable).
p.001579: (ii) DOCUMENTS FOR PARTICIPANTS, BENEFICIARIES, CONTRACTING PROVIDERS, OR AUTHORIZED REPRESENTA- TIVES.—The
p.001579: guidance issued under this paragraph shall include clarifying information and illustrative ex- amples of
p.001579: methods that group health plans and health insurance issuers offering group or individual health insurance
p.001579: coverage may use to provide any partici- pant, beneficiary, contracting provider, or authorized
p.001579: representative, as applicable, with documents con- taining information that the health plans or
p.001579: issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized
p.001579: representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act
p.001579: of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, compliance with any regulation issued
p.001579: pur- suant to such respective section, or compliance with any other applicable law or regulation. Such guidance
p.001579: shall include information that is comparative in na- ture with respect to—
p.001579: (I) nonquantitative treatment limitations for both medical and surgical benefits and mental health and
p.001579: substance use disorder benefits;
p.001579: (II) the processes, strategies, evidentiary standards, and other factors used to apply the
p.001579: limitations described in subclause (I); and
p.001579: (III) the application of the limitations de- scribed in subclause (I) to ensure that such limita- tions
p.001579: are applied in parity with respect to both medical and surgical benefits and mental health and substance
p.001579: use disorder benefits.
p.001579: (C) NONQUANTITATIVE TREATMENT LIMITATIONS.—The guidance issued under this paragraph shall include clari-
p.001579: fying information and illustrative examples of methods, processes, strategies, evidentiary standards, and other
p.001579: fac- tors that group health plans and health insurance issuers offering group or individual health insurance
p.001579: coverage may use regarding the development and application of non-
p.001579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001581: PUBLIC HEALTH SERVICE ACT
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p.001581: January 30, 2020
p.001581: quantitative treatment limitations to ensure compliance with this section, section 712 of the Employee
p.001581: Retirement Income Security Act of 1974, or section 9812 of the Inter- nal Revenue Code of 1986, as
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p.001581: (III) use of fail-first or step therapy protocols;
p.001581: (ii) examples of methods of determining—
p.001581: (I) network admission standards (such as credentialing); and
p.001581: (II) factors used in provider reimbursement methodologies (such as service type, geographic market, demand
p.001581: for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to
p.001581: network adequacy;
p.001581: (iii) examples of sources of information that may serve as evidentiary standards for the purposes of
p.001581: making determinations regarding the development and application of nonquantitative treatment limita-
p.001581: tions;
p.001581: (iv) examples of specific factors, and the evi- dentiary standards used to evaluate such factors, used by
p.001581: such plans or issuers in performing a nonquantita- tive treatment limitation analysis;
p.001581: (v) examples of how specific evidentiary standards may be used to determine whether treatments are con- sidered
p.001581: experimental or investigative;
p.001581: (vi) examples of how specific evidentiary stand- ards may be applied to each service category or classi- fication
p.001581: of benefits;
p.001581: (vii) examples of methods of reaching appropriate coverage determinations for new mental health or sub- stance
p.001581: use disorder treatments, such as evidence- based early intervention programs for individuals with a serious
p.001581: mental illness and types of medical manage- ment techniques;
p.001581: (viii) examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship
p.001581: between the covered mental health or substance use disorder benefit and a traditional cov- ered
p.001581: medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or
p.001581: involuntary commitment; and
p.001581: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001581:
p.001581:
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p.001581: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1582
p.001581:
p.001581: (ix) additional illustrative examples of methods, processes, strategies, evidentiary standards, and other factors
p.001581: for which the Secretary determines that addi- tional guidance is necessary to improve compliance with this
p.001581: section, section 712 of the Employee Retire- ment Income Security Act of 1974, or section 9812 of the
p.001581: Internal Revenue Code of 1986, as applicable.
p.001581: (D) PUBLIC COMMENT.—Prior to issuing any final guid- ance under this paragraph, the Secretary shall provide a
p.001581: public comment period of not less than 60 days during which any member of the public may provide comments on a
p.001581: draft of the guidance.
p.001581: (b) CONSTRUCTION.—Nothing in this section shall be construed—
p.001581: (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage to provide any mental health or substance use disorder benefits; or
p.001581:
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p.001581: (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions
p.001581: of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a).
p.001581: (c) EXEMPTIONS.—
p.001581: (1) SMALL EMPLOYER EXEMPTION.—This section shall not apply to any group health plan and a health
p.001581: insurance issuer offering group or individual health insurance coverage for any plan year of a small employer
p.001581: (as defined in section 2791(e)(4), except that for purposes of this paragraph such term shall in- clude employers with
p.001581: 1 employee in the case of an employer re- siding in a State that permits small groups to include a single individual).
p.001581: (2) COST EXEMPTION.—
p.001581: (A) IN GENERAL.—With respect to a group health plan or a health insurance issuer offering group or individual
p.001581: health insurance coverage, if the application of this section to such plan (or coverage) results in an increase
p.001581: for the plan year involved of the actual total costs of coverage with respect to medical and surgical
p.001581: benefits and mental health and substance use disorder benefits under the plan (as determined and certified under
p.001581: subparagraph (C)) by an amount that exceeds the applicable percentage de- scribed in subparagraph
p.001581: (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or
p.001581: coverage) during the following plan year, and such ex- emption shall apply to the plan (or coverage)
p.001581: for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder
p.001581: parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any
p.001581: increase in total costs.
p.001581: (B) APPLICABLE PERCENTAGE.—With respect to a plan (or coverage), the applicable percentage described
p.001581: in this subparagraph shall be—
p.001581: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001581:
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p.001581:
p.001581:
p.001583: 1583
p.001583: PUBLIC HEALTH SERVICE ACT
p.001583: Sec. 2726
p.001583:
p.001583: (i) 2 percent in the case of the first plan year in which this section is applied; and
p.001583: (ii) 1 percent in the case of each subsequent plan year.
p.001583: (C) DETERMINATIONS BY ACTUARIES.—Determinations as to increases in actual costs under a plan (or
p.001583: coverage) for purposes of this section shall be made and certified by a qualified and licensed actuary who is a member
p.001583: in good standing of the American Academy of Actuaries. All such determinations shall be in a written
p.001583: report prepared by the actuary. The report, and all underlying documentation relied upon by the actuary, shall
p.001583: be maintained by the group health plan or health insurance issuer for a period of 6 years following the
p.001583: notification made under subpara- graph (E).
p.001583: (D) 6-MONTH DETERMINATIONS.—If a group health plan (or a health insurance issuer offering coverage in
p.001583: connec- tion with a group health plan) 11 seeks an exemption under this paragraph, determinations under
p.001583: subparagraph (A) shall be made after such plan (or coverage) has complied with this section for the first 6
p.001583: months of the plan year in- volved.
p.001583: (E) NOTIFICATION.—
p.001583: (i) IN GENERAL.—A group health plan (or a health insurance issuer offering coverage in connection with a group
p.001583: health plan) 11 that, based upon a certification described under subparagraph (C), qualifies for an ex- emption under
p.001583: this paragraph, and elects to imple- ment the exemption, shall promptly notify the Sec- retary, the
p.001583: appropriate State agencies, and partici- pants and beneficiaries in the plan of such election.
p.001583: (ii) REQUIREMENT.—A notification to the Secretary under clause (i) shall include—
p.001583: (I) a description of the number of covered lives under the plan (or coverage) involved at the time of the
p.001583: notification, and as applicable, at the time of any prior election of the cost-exemption under this
p.001583: paragraph by such plan (or coverage);
p.001583: (II) for both the plan year upon which a cost exemption is sought and the year prior, a descrip- tion of the
p.001583: actual total costs of coverage with re- spect to medical and surgical benefits and mental health and substance
p.001583: use disorder benefits under the plan; and
p.001583: (III) for both the plan year upon which a cost exemption is sought and the year prior, the actual total costs of
p.001583: coverage with respect to mental health and substance use disorder benefits under the plan.
p.001583:
p.001583:
p.001583:
p.001583:
p.001583:
p.001583: January 30, 2020
p.001583: 11 In section 1563 (relating to conforming amendments--originally designated as section 1562 and redesignated
p.001583: as section 1563 by section 10107(b)(1)) of Public Law 111–148, Congress may have intended to replace the parenthetical
p.001583: with a reference to both group and individual health insurance. The Congression intent is unclear.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001583: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1584
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p.001583: January 30, 2020
p.001583:
p.001583: (iii) CONFIDENTIALITY.—A notification to the Sec- retary under clause (i) shall be confidential. The Sec-
p.001583: retary shall make available, upon request and on not more than an annual basis, an anonymous itemization of
p.001583: such notifications, that includes—
...

p.001583: beneficiary two or more benefit package options under the plan, the require- ments of this section shall
p.001583: be applied separately with respect to each such option.
p.001583: (e) DEFINITIONS.—For purposes of this section—
p.001583: (1) AGGREGATE LIFETIME LIMIT.—The term ‘‘aggregate life- time limit’’ means, with respect to benefits under
p.001583: a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with
p.001583: respect to such bene- fits under the plan or health insurance coverage with respect to an individual or
p.001583: other coverage unit.
p.001583: (2) ANNUAL LIMIT.—The term ‘‘annual limit’’ means, with respect to benefits under a group health
p.001583: plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid
p.001583: with respect to such benefits in a 12- month period under the plan or health insurance coverage with respect to an
p.001583: individual or other coverage unit.
p.001583: (3) MEDICAL OR SURGICAL BENEFITS.—The term ‘‘medical or surgical benefits’’ means benefits with
p.001583: respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may
p.001583: be), but does not include mental health or substance use disorder benefits.
p.001583: (4) MENTAL HEALTH BENEFITS.—The term ‘‘mental health benefits’’ means benefits with respect to services
p.001583: for mental health conditions, as defined under the terms of the plan and in accordance with applicable
p.001583: Federal and State law.
p.001583: (5) SUBSTANCE USE DISORDER BENEFITS.—The term ‘‘sub- stance use disorder benefits’’ means benefits with
p.001583: respect to services for substance use disorders, as defined under the terms of the plan and in
p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001583:
p.001583:
p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
...

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p.001635: January 30, 2020
p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
p.001635: more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
p.001635: (e) MEETINGS.—The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be
p.001635: an in-per- son meeting.
p.001635: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001635: accordance with section 2811D.
p.001635: (g) SUNSET.—The Advisory Committee shall terminate on Sep- tember 30, 2023.
p.001635: SEC. 2811B. ø42 U.S.C. 300hh-10c¿ NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.
p.001635: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security and the Secretary
p.001635: of Veterans Af-
p.001635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001635:
p.001635:
p.001635:
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p.001635:
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p.001717: (viii) Chronic rhinosinusitis.
p.001717: (ix) Chronic nasopharyngitis.
p.001717: (x) Chronic laryngitis.
p.001717: (xi) Gastroesophageal reflux disorder (GERD).
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001717:
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p.001719: 1719
p.001719: PUBLIC HEALTH SERVICE ACT
p.001719: Sec. 3312
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p.001719: January 30, 2020
p.001719: (xii) Sleep apnea exacerbated by or related to a condition described in a previous clause.
p.001719: (B) MENTAL HEALTH CONDITIONS.—
p.001719: (i) Posttraumatic stress disorder (PTSD).
p.001719: (ii) Major depressive disorder.
p.001719: (iii) Panic disorder.
p.001719: (iv) Generalized anxiety disorder.
p.001719: (v) Anxiety disorder (not otherwise specified).
p.001719: (vi) Depression (not otherwise specified).
p.001719: (vii) Acute stress disorder.
p.001719: (viii) Dysthymic disorder.
p.001719: (ix) Adjustment disorder.
p.001719: (x) Substance abuse.
p.001719: (C) MUSCULOSKELETAL DISORDERS FOR CERTAIN WTC RESPONDERS.—In the case of a WTC responder described in
p.001719: paragraph (4), a condition described in such paragraph.
p.001719: (D) ADDITIONAL CONDITIONS.—Any cancer (or type of cancer) or other condition added, pursuant to paragraph
p.001719: (5) or (6), to the list under this paragraph.
p.001719: (4) MUSCULOSKELETAL DISORDERS.—
p.001719: (A) IN GENERAL.—For purposes of this title, in the case of a WTC responder who received any treatment for a
p.001719: WTC-related musculoskeletal disorder on or before Sep- tember 11, 2003, the list of health conditions in
p.001719: paragraph
p.001719: (3) shall include:
p.001719: (i) Low back pain.
p.001719: (ii) Carpal tunnel syndrome (CTS).
p.001719: (iii) Other musculoskeletal disorders.
p.001719: (B) DEFINITION.—The term ‘‘WTC-related musculo- skeletal disorder’’ means a chronic or recurrent disorder of
p.001719: the musculoskeletal system caused by heavy lifting or re- petitive strain on the joints or
p.001719: musculoskeletal system oc- curring during rescue or recovery efforts in the New York City disaster area
p.001719: in the aftermath of the September 11, 2001, terrorist attacks.
p.001719: (5) CANCER.—
p.001719: (A) IN GENERAL.—The WTC Program Administrator shall periodically conduct a review of all available sci-
p.001719: entific and medical evidence, including findings and rec- ommendations of Clinical Centers of Excellence,
p.001719: published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of
p.001719: cancer should be added to the applicable list of WTC-related health condi- tions. The WTC Program
...

p.001731: same manner as such provisions apply to the monitoring and treatment of WTC-related health conditions for en- rolled
p.001731: WTC responders.
p.001731: (b) LIST OF WTC-RELATED HEALTH CONDITIONS FOR SUR- VIVORS.—The list of health conditions for
p.001731: screening-eligible WTC survivors and certified-eligible WTC survivors consists of the fol- lowing:
p.001731:
p.001731:
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p.001731: January 30, 2020
p.001731: (1) AERODIGESTIVE DISORDERS.—
p.001731: (A) Interstitial lung diseases.
p.001731: (B) Chronic respiratory disorder—fumes/vapors.
p.001731: (C) Asthma.
p.001731: (D) Reactive airways dysfunction syndrome (RADS).
p.001731: (E) WTC-exacerbated chronic obstructive pulmonary disease (COPD).
p.001731: (F) Chronic cough syndrome.
p.001731: (G) Upper airway hyperreactivity.
p.001731: (H) Chronic rhinosinusitis.
p.001731: (I) Chronic nasopharyngitis.
p.001731: (J) Chronic laryngitis.
p.001731: (K) Gastroesophageal reflux disorder (GERD).
p.001731: (L) Sleep apnea exacerbated by or related to a condi- tion described in a previous clause.
p.001731: (2) MENTAL HEALTH CONDITIONS.—
p.001731: (A) Posttraumatic stress disorder (PTSD).
p.001731: (B) Major depressive disorder.
p.001731: (C) Panic disorder.
p.001731: (D) Generalized anxiety disorder.
p.001731: (E) Anxiety disorder (not otherwise specified).
p.001731: (F) Depression (not otherwise specified).
p.001731: (G) Acute stress disorder.
p.001731: (H) Dysthymic disorder.
p.001731: (I) Adjustment disorder.
p.001731: (J) Substance abuse.
p.001731: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001731:
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p.001731:
p.001731: Sec. 3323 PUBLIC HEALTH SERVICE ACT 1732
p.001731:
p.001731: (3) ADDITIONAL CONDITIONS.—Any cancer (or type of can- cer) or other condition added to the list in
p.001731: section 3312(a)(3) pursuant to paragraph (5) or (6) of section 3312(a), as such pro- visions are applied under
p.001731: subsection (a) with respect to cer- tified-eligible WTC survivors.
p.001731: SEC. 3323. ø42 U.S.C. 300mm–33¿ FOLLOWUP MONITORING AND TREAT- MENT OF OTHER INDIVIDUALS WITH
p.001731: WTC-RELATED HEALTH CONDITIONS.
p.001731: (a) IN GENERAL.—Subject to subsection (c), the provisions of section 3322 shall apply to the followup
p.001731: monitoring and treatment of WTC-related health conditions in the case of individuals de- scribed in
p.001731: subsection (b) in the same manner as such provisions apply to the followup monitoring and treatment of
p.001731: WTC-related health conditions for certified-eligible WTC survivors.
p.001731: (b) INDIVIDUALS DESCRIBED.—An individual described in this subsection is an individual who, regardless of
p.001731: location of resi- dence—
p.001731: (1) is not an enrolled WTC responder or a certified-eligible WTC survivor; and
p.001731: (2) is diagnosed at a Clinical Center of Excellence with a WTC-related health condition for
p.001731: certified-eligible WTC sur- vivors.
p.001731: (c) LIMITATION.—
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p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017:
p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
p.000017:
p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
p.000017: (7) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (d) APPLICATION.—
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p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
p.000017:
p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
p.000017: providing pub- lic access to automated external defibrillation; and
p.000017: (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded
p.000017: with the grant in—
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p.000295: January 30, 2020
p.000295: tier communities, or medically underserved areas, or for medically underserved populations; or
p.000295: (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro-
p.000295: viders, in a manner that enhances access to care in the areas and communities, or for the populations,
p.000295: described in clause (i);
p.000295: (D) developing and acquiring instructional program- ming;
p.000295: (E)(i) providing for transmission of medical data, and maintenance of equipment; and
p.000295: (ii) providing for compensation (including travel ex- penses) of specialists, and referring health care
p.000295: providers, who are providing telehealth services through the tele- health network, if no third party
p.000295: payment is available for the telehealth services delivered through the telehealth network;
p.000295: (F) developing projects to use telehealth technology to facilitate collaboration between health care providers;
p.000295: (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the
p.000295: telehealth serv- ices; and
p.000295: (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined
p.000295: by the Secretary.
p.000295: (2) TELEHEALTH RESOURCE CENTERS.—The recipient of a grant under subsection (d)(2) may use funds received
p.000295: through such grant for salaries, equipment, and operating or other costs for—
p.000295: (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care
p.000295: pro- viders and a range of health care entities that provide or will provide telehealth services;
p.000295: (B) disseminating information and research findings related to telehealth services;
p.000295: (C) promoting effective collaboration among telehealth resource centers and the Office;
p.000295: (D) conducting evaluations to determine the best utili- zation of telehealth technologies to meet health care needs;
p.000295: (E) promoting the integration of the technologies used in clinical information systems with other telehealth tech-
p.000295: nologies;
p.000295: (F) fostering the use of telehealth technologies to pro- vide health care information and education for health
p.000295: care providers and consumers in a more effective manner; and
p.000295: (G) implementing special projects or studies under the direction of the Office.
p.000295: (l) PROHIBITED USES OF FUNDS.—An entity that receives a grant under this section may not use funds made
p.000295: available through the grant—
p.000295: (1) to acquire real property;
p.000295: (2) for expenditures to purchase or lease equipment, to the extent that the expenditures would exceed 40 percent
...

p.000491: (l) RESTRICTIONS ON USE OF GRANT.—To be eligible to receive a grant under this section, an entity must
p.000491: agree that the grant will not be expended—
p.000491: (1) to provide inpatient hospital services;
p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: January 30, 2020
p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000491:
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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Health / HIV/AIDS

Searching for indicator HIV:

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p.000017: (a) through (l), there are authorized to be appropriated such sums as may be necessary for each of the
p.000017: fiscal years 1991 through 2003.
p.000017: (2) For activities authorized in paragraphs (1) through (3) of subsection (m), there are authorized to be
p.000017: appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. Of such amounts, the
p.000017: Secretary shall use not more than 10 percent for administration and for activities described in subsection (m)(2).
p.000017: (3) For activities authorized in subsection (m)(4), there are au- thorized to be appropriated $1,000,000 for
p.000017: fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 through 2002.
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p.000017: January 30, 2020
p.000017:
p.000017: INTERNATIONAL COOPERATION
p.000017: SEC. 307. ø242l¿ (a) The Secretary may participate with other countries in cooperative endeavors in—
p.000017: (1) biomedical research, health care technology, and the health services research and statistical analysis
p.000017: authorized under section 306 and title IX; and
p.000017: (2) biomedical research, health care services, health care research, or other related activities in furtherance
p.000017: of the activi- ties, objectives or goals authorized under the Tom Lantos and Henry J. Hyde United States
p.000017: Global Leadership Against HIV/ AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008.
p.000017: (b) In connection with the cooperative endeavors authorized by subsection (a), the Secretary may—
p.000017: (1) make such use of resources offered by participating for- eign countries as he may find necessary and appropriate;
p.000017: (2) establish and maintain fellowships in the United States and in participating foreign countries;
p.000017: (3) make grants to public institutions or agencies and to nonprofit private institutions or agencies in
p.000017: the United States and in participating foreign countries for the purpose of estab- lishing and maintaining the
p.000017: fellowships authorized by para- graph (2);
p.000017: (4) make grants or loans of equipment and materials, for use by public or nonprofit private institutions
p.000017: or agencies, or by individuals, in participating foreign countries;
p.000017: (5) participate and otherwise cooperate in any inter- national meetings, conferences, or other
p.000017: activities concerned
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 307 PUBLIC HEALTH SERVICE ACT 86
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p.000017: of title 48, Code of Federal Regulations (48 CFR 37.104)) in participating for- eign countries, which
p.000017: individuals may not be deemed employ- ees of the United States for the purpose of any law adminis-
p.000017: tered by the Office of Personnel Management;
p.000017: (9) provide such funds by advance or reimbursement to the Secretary of State, as may be necessary, to pay the costs of
p.000017: ac- quisition, lease, construction, alteration, equipping, furnishing or management of facilities outside of
p.000017: the United States; and
p.000017: (10) in consultation with the Secretary of State, through grant or cooperative agreement, make funds available
p.000017: to public or nonprofit private institutions or agencies in foreign coun- tries in which the Secretary is
p.000017: participating in activities de- scribed under subsection (a) to acquire, lease, construct, alter, or
p.000017: renovate facilities in those countries.
p.000017: (c) The Secretary may provide to personnel appointed or as- signed by the Secretary to serve abroad,
p.000017: allowances and benefits similar to those provided under chapter 9 of title I of the Foreign Service Act
p.000017: of 1980 (22 U.S.C. 4081 et seq.). Leaves of absence for personnel under this subsection shall be on the same basis as
p.000017: that provided under subchapter I of chapter 63 of title 5, United States Code or section 903 of the Foreign
p.000017: Service Act of 1980 (22 U.S.C. 4083), to individuals serving in the Foreign Service.
p.000017: (d) In carrying out immunization programs and other programs in developing countries for the prevention,
p.000017: treatment, and control of infectious diseases, including HIV/AIDS, tuberculosis, and ma- laria, the Director
p.000017: of the Centers for Disease Control and Preven- tion, in coordination with the Coordinator of United States
p.000017: Govern- ment Activities to Combat HIV/AIDS Globally, the National Insti- tutes of Health, national and local
p.000017: government, and other organiza- tions, such as the World Health Organization and the United Na- tions
p.000017: Children’s Fund, shall develop and implement effective strat- egies to improve injection safety, including eliminating
p.000017: unnecessary injections, promoting sterile injection practices and technologies, strengthening the procedures
p.000017: for proper needle and syringe dis- posal, and improving the education and information provided to the public and
p.000017: to health professionals.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 87 PUBLIC HEALTH SERVICE ACT Sec. 308
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p.000135: infections, which may include the reporting of cases of such infections.
p.000135: (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph
p.000135: (1) result- ing from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
p.000135: (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified
p.000135: under para- graph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
p.000135: (4) To develop and disseminate public information and education programs for the detection and control of
p.000135: infections described in paragraph (1), with priority given to high-risk populations as determined by the
p.000135: Secretary.
p.000135: (5) To improve the education, training, and skills of health professionals in the detection and control of
p.000135: infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use
p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135: January 30, 2020
p.000135:
p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000359: (B) OVER THE COUNTER DRUGS.—
p.000359: (i) IN GENERAL.—For purposes of subparagraph (A), in the case of over the counter drugs, the ‘‘rebate percentage’’
p.000359: shall be determined as if the rebate re- quired under section 1927(c) of the Social Security Act is based on
p.000359: the applicable percentage provided under section 1927(c)(3) of such Act.
p.000359: (ii) DEFINITION.—The term ‘‘over the counter drug’’ means a drug that may be sold without a pre-
p.000359: scription and which is prescribed by a physician (or other persons authorized to prescribe such drug under
p.000359: State law).
p.000359: (3) DRUGS PROVIDED UNDER STATE MEDICAID PLANS.— Drugs described in this paragraph are drugs purchased
p.000359: by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the
p.000359: Social Secu- rity Act.
p.000359: (4) COVERED ENTITY DEFINED.—In this section, the term ‘‘covered entity’’ means an entity that meets the
p.000359: requirements described in paragraph (5) and is one of the following:
p.000359: (A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act).
p.000359: (B) An entity receiving a grant under section 340A 46.
p.000359: (C) A family planning project receiving a grant or con- tract under section 1001.
p.000359: (D) An entity receiving a grant under subpart II of part C of title XXVI (relating to categorical grants for
p.000359: out- patient early intervention services for HIV disease).
p.000359: (E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under title XXVI.
p.000359: (F) A black lung clinic receiving funds under section 427(a) of the Black Lung Benefits Act.
p.000359: (G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the So-
p.000359: cial Security Act.
p.000359: (H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
p.000359: (I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act.
p.000359:
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p.000359: January 30, 2020
p.000359: 46 See footnote on preceding page. See also footnote for section 217(a).
p.000359: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000361: 361
p.000361: PUBLIC HEALTH SERVICE ACT
p.000361: Sec. 340B
p.000361:
p.000361: (J) Any entity receiving assistance under title XXVI (other than a State or unit of local government or an
p.000361: entity described in subparagraph (D)), but only if the entity is certified by the Secretary pursuant to
p.000361: paragraph (7).
p.000361: (K) An entity receiving funds under section 318 (relat- ing to treatment of sexually transmitted diseases) or
p.000361: sec- tion 317(j)(2) (relating to treatment of tuberculosis) through a State or unit of local government,
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p.000447: 79 So in law. Probably should be paragraph (3).
p.000447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000447:
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p.000447: Sec. 371A PUBLIC HEALTH SERVICE ACT 448
p.000447:
p.000447: mining whether an entity meets the requirement established in paragraph (1)(E).
p.000447: (B) Not later than 1 year after the date of enactment of this paragraph, 80 the Secretary shall publish in
p.000447: the Federal Register a final rule to establish the criteria described in subparagraph (A).
p.000447: (3) An organ procurement organization shall—
p.000447: (A) have effective agreements, to identify potential organ donors, with a substantial majority of the
p.000447: hospitals and other health care entities in its service area which have facilities for organ donations,
p.000447: (B) conduct and participate in systematic efforts, including professional education, to acquire all usable organs from
p.000447: poten- tial donors,
p.000447: (C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of
p.000447: or- gans which are consistent with the standards adopted by the Organ Procurement and Transplantation
p.000447: Network under sec- tion 372(b)(2)(E), including arranging for testing with respect to identifying organs
p.000447: that are infected with human immuno- deficiency virus (HIV),
p.000447: (D) arrange for the appropriate tissue typing of donated or- gans,
p.000447: (E) have a system to allocate donated organs equitably among transplant patients according to established
p.000447: medical cri- teria,
p.000447: (F) provide or arrange for the transportation of donated or- gans to transplant centers,
p.000447: (G) have arrangements to coordinate its activities with transplant centers in its service area,
p.000447: (H) participate in the Organ Procurement Transplantation Network established under section 372,
p.000447: (I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage,
p.000447: and distribu- tion of tissues as may be appropriate to assure that all usable tissues are obtained from potential
p.000447: donors,
p.000447: (J) evaluate annually the effectiveness of the organization in acquiring potentially available organs, and
p.000447: (K) assist hospitals in establishing and implementing pro- tocols for making routine inquiries about organ
p.000447: donations by potential donors.
p.000447: (c) Pancreata procured by an organ procurement organization and used for islet cell transplantation or research
p.000447: shall be counted for purposes of certification or recertification under subsection (b).
p.000447: SEC. 371A. ø273a¿ NATIONAL LIVING DONOR MECHANISMS.
p.000447: The Secretary may establish and maintain mechanisms to evaluate the long-term effects associated with
p.000447: living organ dona- tions by individuals who have served as living donors.
p.000447:
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p.000447: January 30, 2020
p.000447: ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
p.000447: SEC. 372. ø274¿ (a) The Secretary shall by contract provide for the establishment and operation of an Organ
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p.000449:
p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
p.000449:
p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
p.000449: (1) receiving from interested persons critical comments re- lating to the manner in which the Organ Procurement
p.000449: and Transplantation Network is carrying out the duties of the Net- work under subsection (b); and
p.000449: (2) the consideration by the Secretary of such critical com- ments.
p.000449: SCIENTIFIC REGISTRY
p.000449: SEC. 373. ø274a¿ The Secretary shall, by grant or contract, de- velop and maintain a scientific registry of the
p.000449: recipients of organ transplants. The registry shall include such information respecting patients and transplant
p.000449: procedures as the Secretary deems nec- essary to an ongoing evaluation of the scientific and clinical status of
p.000449: organ transplantation. The Secretary shall prepare for inclusion
p.000449:
p.000449:
p.000449:
p.000449: January 30, 2020
p.000449: 81 Indentation is so in law. See section 2101(a)(3) of Public Law 106–310 (114 Stat. 1156).
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000455: or con-
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p.000457: 457
p.000457: PUBLIC HEALTH SERVICE ACT
p.000457: Sec. 377E
p.000457:
p.000457: ducted basic, clinical, and health services research (includ- ing research on preservation techniques and organ
p.000457: rejec- tion and compatibility); and
p.000457: (B) the coordination of such efforts across relevant agencies within the Department and throughout the
p.000457: Fed- eral Government.
p.000457: (4) An evaluation of the costs and benefits of State donor registries, including the status of existing
p.000457: State donor reg- istries, the effect of State donor registries on organ donation rates, issues relating to
p.000457: consent, and recommendations regard- ing improving the effectiveness of State donor registries in in- creasing overall
p.000457: organ donation rates.
p.000457: (5) A plan to improve federally supported or conducted organ donation and recovery activities, including, when
p.000457: appro- priate, the establishment of baselines and benchmarks to measure overall outcomes of these
p.000457: programs. Such plan shall provide for the ongoing coordination of federally supported or conducted organ
p.000457: donation and research activities.
p.000457: SEC. 377E. ø274f–5¿ CRITERIA, STANDARDS, AND REGULATIONS WITH RESPECT TO ORGANS INFECTED WITH HIV.
p.000457: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of the HIV Organ Policy Equity Act,
p.000457: the Secretary shall develop and publish criteria for the conduct of research relating to transplantation of organs
p.000457: from donors infected with human im- munodeficiency virus (in this section referred to as ‘‘HIV’’) into in-
p.000457: dividuals who are infected with HIV before receiving such organ.
p.000457: (b) CORRESPONDING CHANGES TO STANDARDS AND REGULATIONS APPLICABLE TO RESEARCH.—Not later than 2 years after
p.000457: the date of the enactment of the HIV Organ Policy Equity Act, to the extent determined by the Secretary to
p.000457: be necessary to allow the conduct of research in accordance with the criteria developed under sub-
p.000457: section (a)—
p.000457: (1) the Organ Procurement and Transplantation Network shall revise the standards of quality adopted under
p.000457: section 372(b)(2)(E); and
p.000457: (2) the Secretary shall revise section 121.6 of title 42, Code of Federal Regulations (or any successor regulations).
p.000457: (c) REVISION OF STANDARDS AND REGULATIONS GENERALLY.— Not later than 4 years after the date of the enactment of
p.000457: the HIV Organ Policy Equity Act, and annually thereafter, the Secretary, shall—
p.000457:
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p.000457: January 30, 2020
p.000457: (1) review the results of scientific research in conjunction with the Organ Procurement and
p.000457: Transplantation Network to determine whether the results warrant revision of the stand- ards of quality
p.000457: adopted under section 372(b)(2)(E) with respect to donated organs infected with HIV and with respect to the
p.000457: safety of transplanting an organ with a particular strain of HIV into a recipient with a different strain of
p.000457: HIV;
p.000457: (2) if the Secretary determines under paragraph (1) that such results warrant revision of the standards of
p.000457: quality adopt- ed under section 372(b)(2)(E) with respect to donated organs infected with HIV and with
p.000457: respect to transplanting an organ with a particular strain of HIV into a recipient with a different strain of
p.000457: HIV, direct the Organ Procurement and Transplan-
p.000457: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000457:
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p.000457: Sec. 378 PUBLIC HEALTH SERVICE ACT 458
p.000457:
p.000457: tation Network to revise such standards, consistent with sec- tion 372 and in a way that ensures the changes
p.000457: will not reduce the safety of organ transplantation; and
p.000457: (3) in conjunction with any revision of such standards under paragraph (2), revise section 121.6 of
p.000457: title 42, Code of Federal Regulations (or any successor regulations).
p.000457: SEC. 378. ø274g¿ AUTHORIZATION OF APPROPRIATIONS.
p.000457: For the purpose of carrying out this part, there are authorized to be appropriated $8,000,000 for fiscal year
p.000457: 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
p.000457:
p.000457: PART I—C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM
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p.000457: January 30, 2020
p.000457: SEC. 379. ø274k¿ NATIONAL PROGRAM.
p.000457: (a) ESTABLISHMENT.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
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p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
p.000749:
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p.000749: January 30, 2020
p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000751: 751
p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000751: with respect to AIDS research related to—
p.000751: (1) primary prevention of the spread of HIV, including transmission via drug abuse;
p.000751: (2) drug abuse services research; and
p.000751: (3) other matters determined appropriate by the Director.
p.000751:
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p.000751: January 30, 2020
p.000751:
p.000751: MEDICATION DEVELOPMENT PROGRAM
p.000751: SEC. 464P. ø285o–4¿ (a) ESTABLISHMENT.—There is established in the Institute a Medication Development Program
p.000751: through which the Director of such Institute shall—
p.000751: (1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate
p.000751: the ap- proval process of drug abuse treatments;
p.000751: (2) encourage and promote (through grants, contracts, international collaboration, or otherwise)
p.000751: expanded research programs, investigations, experiments, community trials, and studies, into the development
p.000751: and use of medications to treat drug addiction;
p.000751: (3) establish or provide for the establishment of research facilities;
...

p.000753: the Institute and with the Di- rector of the Office of Rural Health Policy, shall—
p.000753: (1) coordinate the research activities of the Department of Health and Human Services as such activities relate
p.000753: to the mental health of residents of rural areas; and
p.000753: (2) coordinate the activities of the Office with similar ac- tivities of public and nonprofit private
p.000753: entities.
p.000753: (c) RESEARCH, DEMONSTRATIONS, EVALUATIONS, AND DISSEMI- NATION.—The Director of the Office may, with respect to
p.000753: the men- tal health of adults and children residing in rural areas—
p.000753: (1) conduct research on conditions that are unique to the residents of rural areas, or more serious or
p.000753: prevalent in such residents;
p.000753: (2) conduct research on improving the delivery of services in such areas; and
p.000753: (3) disseminate information to appropriate public and non- profit private entities.
p.000753: (d) AUTHORITY REGARDING GRANTS AND CONTRACTS.—The Di- rector of the Office may carry out the authorities
p.000753: established in subsection (c) directly and through grants, cooperative agreements, or contracts with public or
p.000753: nonprofit private entities.
p.000753: OFFICE ON AIDS
p.000753: SEC. 464U. ø285p–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000753: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000753: with respect to AIDS research related to—
p.000753: (1) primary prevention of the spread of HIV, including transmission via sexual behavior;
p.000753: (2) mental health services research; and
p.000753: (3) other matters determined appropriate by the Director.
p.000753: Subpart 17—National Institute of Nursing Research
p.000753: PURPOSE OF THE INSTITUTE
p.000753: SEC. 464V. ø285q¿ The general purpose of the National Insti- tute of Nursing Research (in this subpart referred
p.000753: to as the ‘‘Insti- tute’’) is the conduct and support of, and dissemination of informa- tion respecting, basic and
p.000753: clinical nursing research, training, and other programs in patient care research.
p.000753:
p.000753:
p.000753:
p.000753:
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p.000753:
p.000753: January 30, 2020
p.000753: SPECIFIC AUTHORITIES
p.000753: SEC. 464W. ø285q–1¿ To carry out section 464V, the Director of the Institute may provide research training and
p.000753: instruction and establish, in the Institute and other nonprofit institutions, research
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000753:
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p.000755: PUBLIC HEALTH SERVICE ACT
p.000755: Sec. 464X
p.000755:
p.000755: traineeships and fellowships in the study and investigation of the prevention of disease, health promotion,
p.000755: and the nursing care of in- dividuals with and the families of individuals with acute and chronic illnesses.
p.000755: The Director of the Institute may provide individ- uals receiving such training and instruction or such traineeships or
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p.000825: prevention and related serv- ices;
p.000825: (5) support activities that will improve the provision of treatment, prevention and related services, including
p.000825: the devel-
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000825: Sec. 501 PUBLIC HEALTH SERVICE ACT 826
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p.000825: opment of national mental health and substance use disorder goals and model programs;
p.000825: (6) in cooperation with the National Institutes of Health, the Centers for Disease Control and
p.000825: Prevention, and the Health Resources and Services Administration, develop edu- cational materials and
p.000825: intervention strategies to reduce the risks of HIV, hepatitis, tuberculosis, and other communicable diseases
p.000825: among individuals with mental or substance use dis- orders, and to develop appropriate mental health
p.000825: services for individuals with such diseases or disorders;
p.000825: (7) coordinate Federal policy with respect to the provision of treatment services for substance use
p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
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p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: 861
p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
p.000861:
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
p.000861: under the Drug Free Schools and Communities Act of 1986;
p.000861: (9) support the development of model, innovative, commu- nity-based programs that reduce the risk of
p.000861: alcohol and drug abuse among young people and promote resiliency;
p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
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p.000919: med- ical students, and physicians and other prescribers of schedule II, III, or IV controlled
p.000919: substances on relevant prescribing guidelines, the prescription drug monitoring program of the State
p.000919: described in subparagraph (B), and overdose prevention methods;
p.000919: (B) establishing, maintaining, or improving a com- prehensive prescription drug monitoring program to track
p.000919: dispensing of schedule II, III, or IV controlled substances, which may—
p.000919: (i) provide for data sharing with other States; and
p.000919: (ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled
p.000919: substances to access the prescription drug monitoring program of the State;
p.000919: (C) developing, implementing, or expanding prescrip- tion drug and opioid addiction treatment programs by—
p.000919: (i) expanding the availability of treatment for pre- scription drug and opioid addiction, including medica-
p.000919: tion-assisted treatment and behavioral health therapy, as appropriate;
p.000919: (ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug
p.000919: and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically ap-
p.000919: propriate; or
p.000919: (iii) developing, implementing, or expanding recov- ery support services and programs at high schools or
p.000919: institutions of higher education;
p.000919: (D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to
p.000919: prescription medications and opioids; and
p.000919: (E) advancing the education and awareness of the pub- lic, providers, patients, consumers, and other appropriate
p.000919: entities regarding the dangers of opioid abuse, safe dis- posal of prescription medications, and detection
p.000919: of early warning signs of opioid use disorders.
p.000919: (3) APPLICATION.—A State seeking a grant under this sec- tion shall submit to the Secretary an application in such
p.000919: form, and containing such information, as the Secretary may reason- ably require.
p.000919: (4) USE OF FUNDS.—A State that receives a grant under this section shall use the grant for the cost, including
p.000919: the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid
p.000919: abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established
p.000919: under paragraph (2).
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p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001025: PUBLIC HEALTH SERVICE ACT
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p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
...

p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
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p.001091: January 30, 2020
p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: Sec. 831 PUBLIC HEALTH SERVICE ACT 1092
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
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p.001311: able tuberculosis services to each individual receiving treatment for such disorders; and
p.001311: (B) in the case of an individual in need of such treat- ment who is denied admission to the program on the
p.001311: basis of the lack of the capacity of the program to admit the in- dividual, will refer the individual to another
p.001311: provider of tu- berculosis services.
p.001311: (2) TUBERCULOSIS SERVICES.—For purposes of paragraph (1), the term ‘‘tuberculosis services’’, with
p.001311: respect to an indi- vidual, means—
p.001311: (A) counseling the individual with respect to tuber- culosis;
p.001311: (B) testing to determine whether the individual has contracted such disease and testing to determine the form of
p.001311: treatment for the disease that is appropriate for the in- dividual; and
p.001311: (C) providing such treatment to the individual.
p.001311: (b) HUMAN IMMUNODEFICIENCY VIRUS.—
p.001311: (1) REQUIREMENT FOR CERTAIN STATES.—In the case of a State described in paragraph (2), a funding
p.001311: agreement for a grant under section 1921 is that—
p.001311: (A) with respect to individuals undergoing treatment for substance use disorders, the State will, subject to
p.001311: para- graph (3), carry out 1 or more projects to make available to the individuals early intervention
p.001311: services for HIV dis- ease at the sites at which the individuals are undergoing such treatment;
p.001311: (B) for the purpose of providing such early interven- tion services through such projects, the State
p.001311: will make available from the grant the percentage that is applicable for the State under paragraph (4); and
p.001311: (C) the State will, subject to paragraph (5), carry out such projects only in geographic areas of the
p.001311: State that have the greatest need for the projects.
p.001311: (2) DESIGNATED STATES.—For purposes of this subsection, a State described in this paragraph is any State
p.001311: whose rate of cases of acquired immune deficiency syndrome is 10 or more such cases per 100,000 individuals
p.001311: (as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control
p.001311: and Prevention for the most recent calendar year for which such data are available).
p.001311: (3) USE OF EXISTING PROGRAMS REGARDING SUBSTANCE USE DISORDERS.—With respect to programs that provide
p.001311: treatment services for substance use disorders, a funding agreement for a grant under section 1921 for a
p.001311: designated State is that each such program participating in a project under paragraph (1) will be a program
p.001311: that began operation prior to the fiscal year for which the State is applying to receive the grant. A program that so
p.001311: began operation may participate in a project under paragraph (1) without regard to whether the program has been
p.001311: providing early intervention services for HIV disease.
p.001311: (4) APPLICABLE PERCENTAGE REGARDING EXPENDITURES FOR SERVICES.—
p.001311: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001311: Sec. 1924 PUBLIC HEALTH SERVICE ACT 1312
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p.001311: (A)(i) For purposes of paragraph (1)(B), the percentage that is applicable under this paragraph for a
p.001311: designated State is, subject to subparagraph (B), the percentage by which the amount of the grant under section
p.001311: 1921 for the State for the fiscal year involved is an increase over the amount specified in clause (ii).
p.001311: (ii) The amount specified in this clause is the amount that was reserved by the designated State involved from
p.001311: the allotment of the State under section 1912A for fiscal year 1991 in compliance with section
p.001311: 1916(c)(6)(A)(ii) (as such sections were in effect for such fiscal year).
p.001311: (B) If the percentage determined under subparagraph
p.001311: (A) for a designated State for a fiscal year is less than 2 percent (including a negative percentage,
p.001311: in the case of a State for which there is no increase for purposes of such subparagraph), the percentage
p.001311: applicable under this para- graph for the State is 2 percent. If the percentage so deter- mined is 2 percent or
p.001311: more, the percentage applicable under this paragraph for the State is the percentage deter- mined under subparagraph
p.001311: (A), subject to not exceeding 5 percent.
p.001311: (5) REQUIREMENT REGARDING RURAL AREAS.—
p.001311: (A) A funding agreement for a grant under section 1921 for a designated State is that, if the State will carry
p.001311: out 2 or more projects under paragraph (1), the State will carry out 1 such project in a rural area of the
p.001311: State, sub- ject to subparagraph (B).
p.001311: (B) The Secretary shall waive the requirement estab- lished in subparagraph (A) if the State involved certifies
p.001311: to the Secretary that—
p.001311: (i) there is insufficient demand in the State to carry out a project under paragraph (1) in any rural
p.001311: area of the State; or
p.001311: (ii) there are no rural areas in the State.
p.001311: (6) MANNER OF PROVIDING SERVICES.—With respect to the provision of early intervention services for HIV
p.001311: disease to an individual, a funding agreement for a grant under section 1921 for a designated State is that—
p.001311: (A) such services will be undertaken voluntarily by, and with the informed consent of, the individual; and
p.001311: (B) undergoing such services will not be required as a condition of receiving treatment services for substance use
p.001311: disorders or any other services.
p.001311: (7) DEFINITIONS.—For purposes of this subsection:
p.001311: (A) The term ‘‘designated State’’ means a State de- scribed in paragraph (2).
p.001311: (B) The term ‘‘early intervention services’’, with re- spect to HIV disease, means—
p.001311: (i) appropriate pretest counseling;
p.001311: (ii) testing individuals with respect to such dis- ease, including tests to confirm the presence of the dis-
p.001311: ease, tests to diagnose the extent of the deficiency in the immune system, and tests to provide
p.001311: information on appropriate therapeutic measures for preventing
p.001311: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001313: 1313
p.001313: PUBLIC HEALTH SERVICE ACT
p.001313: Sec. 1925
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p.001313: and treating the deterioration of the immune system and for preventing and treating conditions
p.001313: arising from the disease;
p.001313: (iii) appropriate post-test counseling; and
p.001313: (iv) providing the therapeutic measures described in clause (ii).
p.001313: (C) The term ‘‘HIV disease’’ means infection with the etiologic agent for acquired immune deficiency
p.001313: syndrome.
p.001313: (c) EXPENDITURE OF GRANT FOR COMPLIANCE WITH AGREE-
p.001313: MENTS.—
p.001313: (1) IN GENERAL.—A grant under section 1921 may be ex- pended for purposes of compliance with the
p.001313: agreements re- quired in this section, subject to paragraph (2).
p.001313: (2) LIMITATION.—A funding agreement for a grant under section 1921 for a State is that the grant will not be
p.001313: expended to make payment for any service provided for purposes of com- pliance with this section to the extent
p.001313: that payment has been made, or can reasonably be expected to be made, with respect to such service—
p.001313: (A) under any State compensation program, under any insurance policy, or under any Federal or State health
p.001313: benefits program (including the program established in title XVIII of the Social Security Act and the
p.001313: program es- tablished in title XIX of such Act); or
p.001313: (B) by an entity that provides health services on a pre- paid basis.
p.001313: (d) APPLICABILITY OF CERTAIN PROVISION.—Section 1931 ap- plies to this section (and to each other
p.001313: provision of this subpart).
p.001313: SEC. 1925. ø300x–25¿ GROUP HOMES FOR PERSONS IN RECOVERY FROM SUBSTANCE USE DISORDERS.
p.001313: (a) STATE REVOLVING FUNDS FOR ESTABLISHMENT OF HOMES.— A State, using funds available under section 1921,
p.001313: may establish and maintain the ongoing operation of a revolving fund in accord- ance with this section to
p.001313: support group homes for persons in recov- ery from substance use disorders as follows:
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p.001331: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.001331: Secretary shall reduce the amount of payments under the program in-
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
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p.001339: PUBLIC HEALTH SERVICE ACT
p.001339: Sec. 1976
p.001339:
p.001339: (e) DURATION OF SUPPORT.—The period during which payments may be made for a project under subsection (a) may
p.001339: be not less than 3 years nor more than 5 years.
p.001339: (f) AUTHORIZATION OF APPROPRIATION.—
p.001339: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated such
p.001339: sums as may be necessary for each of the fiscal years 2001, 2002 and 2003.
p.001339: (2) ALLOCATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall
p.001339: be expended to support data infrastructure development for mental health and 50 percent shall be expended
p.001339: to support data infrastruc- ture development for substance abuse.
p.001339:
p.001339: Subpart II—Interim Maintenance Treatment of Narcotics Dependence
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p.001339: SEC. 1976. ø300y–11¿ INTERIM MAINTENANCE TREATMENT.
p.001339: (a) REQUIREMENT REGARDING SECRETARY.—Subject to the fol- lowing subsections of this section, for the
p.001339: purpose of reducing the incidence of the transmission of HIV disease pursuant to the intra- venous abuse of heroin
p.001339: or other morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or
p.001339: nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs—
p.001339: (1) to dispense methadone for treatment purposes to indi- viduals who—
p.001339: (A) meet the conditions for admission to such pro- grams that dispense methadone as part of
p.001339: comprehensive treatment for such dependence; and
p.001339: (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity
p.001339: of the programs, will not gain such admission until 14 or more days after seeking admission to the programs;
p.001339: and
p.001339: (2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in
p.001339: which the individuals are waiting for admission to programs of com- prehensive treatment.
p.001339: (b) INAPPLICABILITY OF REQUIREMENT IN CERTAIN CIR-
p.001339: CUMSTANCES.—
p.001339: (1) IN GENERAL.—The requirement established in sub- section (a) for the Secretary does not apply if any or
p.001339: all of the following conditions are met:
p.001339: (A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease
p.001339: pursuant to the intravenous abuse of drugs is minimal.
p.001339: (B) The preponderance of scientific research indicates that the medically supervised dispensing of
p.001339: methadone is not an effective method of reducing the extent of depend- ence on heroin and other morphine-like
p.001339: drugs.
p.001339: (C) The preponderance of available data indicates that, of treatment programs that dispense methadone
p.001339: as part of comprehensive treatment, a substantial majority
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001339: Sec. 1976 PUBLIC HEALTH SERVICE ACT 1340
p.001339:
p.001339: admit all individuals seeking services to the programs not later than 14 days after the individuals seek admission to
p.001339: the programs.
p.001339: (2) EVALUATION BY SECRETARY.—In evaluating whether any or all of the conditions described in
p.001339: paragraph (1) have been met, the Secretary shall consult with the National Com- mission on Acquired Immune
p.001339: Deficiency Syndrome.
p.001339: (c) CONDITIONS FOR OBTAINING AUTHORIZATION FROM SEC-
p.001339: RETARY.—
p.001339: (1) IN GENERAL.—In carrying out the requirement estab- lished in subsection (a), the Secretary shall, after
p.001339: consultation with the National Commission on Acquired Immune Deficiency Syndrome, by regulation issue such
p.001339: conditions for treatment programs to obtain authorization from the Secretary to provide interim maintenance
p.001339: treatment as may be necessary to carry out the purpose described in such subsection. Such conditions
p.001339: shall include conditions for preventing the unauthorized use of methadone.
p.001339: (2) COUNSELING ON HIV DISEASE.—The regulations issued under paragraph (1) shall provide that an
p.001339: authorization de- scribed in such paragraph may not be issued to a treatment program unless the program
p.001339: provides to recipients of the treat- ment counseling on preventing exposure to and the trans- mission of HIV
p.001339: disease.
p.001339: (3) PERMISSION OF RELEVANT STATE AS CONDITION OF AU- THORIZATION.—The regulations issued under
p.001339: paragraph (1) shall provide that the Secretary may not provide an authoriza- tion described in such paragraph to any
p.001339: treatment program in a State unless the chief public health officer of the State has certified to the
p.001339: Secretary that—
p.001339: (A) such officer does not object to the provision of such authorizations to treatment programs in the State; and
p.001339: (B) the provision of interim maintenance services in the State will not reduce the capacity of
p.001339: comprehensive treatment programs in the State to admit individuals to the programs (relative to the date on
p.001339: which such officer so certifies).
p.001339: (4) DATE CERTAIN FOR ISSUANCE OF REGULATIONS; FAILURE OF SECRETARY.—The Secretary shall issue the final
p.001339: rule for purposes of the regulations required in paragraph (1), and such rule shall be effective, not later than the
p.001339: expiration of the 180- day period beginning on the date of the enactment of the ADAMHA Reorganization Act
p.001339: 20. If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued
p.001339: on March 2, 1989, with respect to part 291 of title 21, Code of Federal Regulations (docket numbered
p.001339: 88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and
p.001339: the provisions of para- graph (3) of this subsection are deemed to be incorporated into such rule.
p.001339: (d) DEFINITIONS.—For purposes of this section:
p.001339:
p.001339:
p.001339:
p.001339: January 30, 2020
p.001339: 20 Enacted July 10, 1992.
p.001339:
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001339:
p.001339:
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p.001339:
p.001339:
p.001341: 1341
p.001341: PUBLIC HEALTH SERVICE ACT
p.001341: Sec. 2001
p.001341:
p.001341: (1) The term ‘‘interim maintenance services’’ means the provision of methadone in a treatment program under the
p.001341: cir- cumstances described in paragraphs (1) and (2) of subsection (a).
p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
p.001341: (3) The term ‘‘treatment program’’ means a public or non- profit private program of treatment for
p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
p.001341:
p.001341:
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p.001341:
p.001341:
p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
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p.001405: effects associ- ated with the use or administration of such experimental treat- ment.
p.001405: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001405: Sec. 2318 PUBLIC HEALTH SERVICE ACT 1406
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p.001405: January 30, 2020
p.001405:
p.001405: SEC. 2318. ø300cc–18¿ DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE OF INFECTED INDIVIDUALS.
p.001405: (a) IN GENERAL.—
p.001405: (1) The Secretary, acting through the Director of the Na- tional Institutes of Health and after consultation
p.001405: with the Ad- ministrator for Health Care Policy and Research, may make grants to public and nonprofit private
p.001405: entities for the establish- ment of projects to develop model protocols for the clinical care of individuals infected
p.001405: with the etiologic agent for acquired im- mune deficiency syndrome, including treatment and prevention of HIV infection
p.001405: and related conditions among women.
p.001405: (2) The Secretary may not make a grant under paragraph
p.001405: (1) unless—
p.001405: (A) the applicant for the grant is a provider of com- prehensive primary care; or
p.001405: (B) the applicant for the grant agrees, with respect to the project carried out pursuant to paragraph (1), to enter
p.001405: into a cooperative arrangement with an entity that is a provider of comprehensive primary care.
p.001405: (b) REQUIREMENT OF PROVISION OF CERTAIN SERVICES.—The Secretary may not make a grant under subsection
p.001405: (a) unless the applicant for the grant agrees that, with respect to patients partici- pating in the project
p.001405: carried out with the grant, services provided pursuant to the grant will include—
p.001405: (1) monitoring, in clinical laboratories, of the condition of such patients;
p.001405: (2) clinical intervention for infection with the etiologic agent for acquired immune deficiency
p.001405: syndrome, including measures for the prevention of conditions arising from the in- fection;
p.001405: (3) information and counseling on the availability of treat- ments for such infection approved by the Commissioner of
p.001405: Food and Drugs, on the availability of treatments for such infection not yet approved by the Commissioner, and
p.001405: on the reports issued by the AIDS Research Advisory Committee under sec- tion 2304(c)(2)(B);
p.001405: (4) support groups; and
p.001405: (5) information on, and referrals to, entities providing ap- propriate social support services.
p.001405: (c) LIMITATION ON IMPOSITION OF CHARGES FOR SERVICES.— The Secretary may not make a grant under
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p.001409: conditions, be- tween these various agencies for dissemination to affected communities and health care providers.
p.001409: SEC. 2351A. ø300cc–40a¿ MICROBICIDE RESEARCH.
p.001409: (a) FEDERAL STRATEGIC PLAN.—The Director of the Office shall—
p.001409:
p.001409:
p.001409:
p.001409:
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p.001409:
p.001409:
p.001409:
p.001409: January 30, 2020
p.001409: (1) expedite the implementation of the Federal strategic plans required by section 403(a) of the Public
p.001409: Health Service Act (42 U.S.C. 283(a)(5)) regarding the conduct and support of research on, and development of, a
p.001409: microbicide to prevent the transmission of the human immunodeficiency virus; and
p.001409: (2) review and, as appropriate, revise such plan to prioritize funding and activities relative to
p.001409: their scientific ur- gency and potential market readiness.
p.001409: (b) COORDINATION.—In implementing, reviewing, and prioritizing elements of the plan described in
p.001409: subsection (a), the Di- rector of the Office shall consult, as appropriate, with—
p.001409: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001409:
p.001409:
p.001409:
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p.001409:
p.001409:
p.001411: 1411
p.001411: PUBLIC HEALTH SERVICE ACT
p.001411: Sec. 2353
p.001411:
p.001411: (1) representatives of other Federal agencies involved in microbicide research, including the
p.001411: Coordinator of United States Government Activities to Combat HIV/AIDS Globally, the Director of the Centers
p.001411: for Disease Control and Prevention, and the Administrator of the United States Agency for Inter- national
p.001411: Development;
p.001411: (2) the microbicide research and development community;
p.001411: and
p.001411: (3) health advocates.
p.001411:
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p.001411: January 30, 2020
p.001411: SEC. 2352. ø300cc–40a¿ ADVISORY COUNCIL; COORDINATING COMMIT- TEES.
p.001411: (a) ADVISORY COUNCIL.—
p.001411: (1) IN GENERAL.—The Secretary shall establish an advisory council for the purpose of providing advice to the
p.001411: Director of the Office on carrying out this part. (Such council is referred to in this subsection as the
p.001411: ‘‘Advisory Council’’.)
p.001411: (2) COMPOSITION, COMPENSATION, TERMS, CHAIR, ETC.— Subsections (b) through (g) of section 406 apply to the
p.001411: Advisory Council to the same extent and in the same manner as such subsections apply to advisory councils
p.001411: for the national research institutes, except that—
p.001411: (A) in addition to the ex officio members specified in section 406(b)(2), there shall serve as such members of
p.001411: the Advisory Council a representative from the advisory coun- cil of each of the National Cancer Institute and
p.001411: the Na- tional Institute on Allergy and Infectious Diseases; and
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p.001441:
p.001441:
p.001441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001441: Sec. 2524 PUBLIC HEALTH SERVICE ACT 1442
p.001441:
p.001441: SEC. 2524. ø300ee–34¿ AUTHORIZATION OF APPROPRIATIONS.
p.001441: (a) IN GENERAL.—For the purpose of carrying out sections 2521 through 2523, there are authorized to
p.001441: be appropriated
p.001441: $105,000,000 for fiscal year 1989 and such sums as may be nec- essary for each of the fiscal years 1990 and
p.001441: 1991.
p.001441: (b) ALLOCATIONS.—
p.001441: (1) Of the amounts appropriated pursuant to subsection (a), the Secretary shall make available $45,000,000 to
p.001441: carry out section 2522 and $30,000,000 to carry out this part through fi- nancial assistance to minority entities for
p.001441: the provision of serv- ices to minority populations.
p.001441: (2) After consultation with the Director of the Office of Mi- nority Health and with the Indian Health Service,
p.001441: the Sec- retary, acting through the Director of the Centers for Disease Control and Prevention, shall, not
p.001441: later than 90 days after the date of the enactment of the AIDS Amendments of 1988, 6 pub- lish guidelines to
p.001441: provide procedures for applications for fund- ing pursuant to paragraph (1) and for public comment.
p.001441:
p.001441: TITLE XXVI—HIV HEALTH CARE SERVICES PROGRAM 1
p.001441: PART A—EMERGENCY RELIEF FOR AREAS WITH SUBSTANTIAL NEED
p.001441: FOR SERVICES 2
p.001441: Subpart I—General Grant Provisions
p.001441: SEC. 2601. ø300ff–11¿ ESTABLISHMENT OF PROGRAM OF GRANTS.
p.001441: (a) ELIGIBLE AREAS.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001441: Administration, shall, subject to subsections (b) through (c), make grants in accord- ance with section 2603 for the
p.001441: purpose of assisting in the provision of the services specified in section 2604 in any metropolitan area for
p.001441: which there has been reported to and confirmed by the Director of the Centers for Disease Control and Prevention
p.001441: a cumulative total of more than 2,000 cases of AIDS during the most recent pe- riod of 5 calendar years for which
p.001441: such data are available.
p.001441: (b) CONTINUED STATUS AS ELIGIBLE AREA.—Notwithstanding any other provision of this section, a
p.001441: metropolitan area that is an eligible area for a fiscal year continues to be an eligible area until the
p.001441: metropolitan area fails, for three consecutive fiscal years—
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p.001441: January 30, 2020
p.001441: 6 Enacted on November 4, 1988.
p.001441: 1 This title was added by Public Law 101–381. Section 2 of that Public Law provides as fol- lows: ‘‘It
p.001441: is the purpose of this Act to provide emergency assistance to localities that are dis- proportionately
p.001441: affected by the Human Immunodeficiency Virus epidemic and to make financial assistance available to States and
p.001441: other public or private nonprofit entities to provide for the development, organization, coordination and
p.001441: operation of more effective and cost efficient sys- tems for the delivery of essential services to individuals
p.001441: and families with HIV disease.’’.
p.001441: 2 Section 502 of Public Law 106–345 (114 Stat. 1353) relates to the development of reliable and
p.001441: affordable tests for HIV disease that can rapidly be administered and whose results can rapidly be
p.001441: obtained.
p.001441: With respect to information for determining formula grants under parts A and B, section 501(a) of Public
p.001441: Law 106–345 (114 Stat. 1352) provides for a study of State surveillance systems regarding cases of infection with
p.001441: the human immunodeficiency virus. Section 501(d)(1) of such Law requires that a report of the findings of the
p.001441: study be submitted not later than 3 years after the date of the enactment of the Law, which was enacted October 20,
p.001441: 2000.
p.001441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001443: PUBLIC HEALTH SERVICE ACT
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p.001443: January 30, 2020
p.001443: (1) to meet the requirements of subsection (a); and
p.001443: (2) to have a cumulative total of 3,000 or more living cases of AIDS (reported to and confirmed by the Director of the
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p.001443: or
p.001443: (2) with respect to a metropolitan area that becomes eligi- ble to receive funding under this subpart in any
p.001443: fiscal year after fiscal year 2006, the boundaries of such metropolitan area shall be the boundaries that are in
p.001443: effect for such area when such area initially receives funding under this subpart.
p.001443: SEC. 2602. ø300ff–12¿ ADMINISTRATION AND PLANNING COUNCIL.
p.001443: (a) ADMINISTRATION.—
p.001443: (1) IN GENERAL.—Assistance made available under grants awarded under this subpart shall be directed to the chief
p.001443: elect- ed official of the city or urban county that administers the pub- lic health agency that provides
p.001443: outpatient and ambulatory services to the greatest number of individuals with AIDS, as reported to and
p.001443: confirmed by the Centers for Disease Control and Prevention, in the eligible area that is awarded such
p.001443: a grant.
p.001443: (2) REQUIREMENTS.—
p.001443: (A) IN GENERAL.—To receive assistance under section 2601(a), the chief elected official of the eligible
p.001443: area in- volved shall—
p.001443: (i) establish, through intergovernmental agree- ments with the chief elected officials of the political
p.001443: subdivisions described in subparagraph (B), an admin- istrative mechanism to allocate funds and services based
p.001443: on—
p.001443: (I) the number of AIDS cases in such subdivi- sions;
p.001443: (II) the severity of need for outpatient and ambulatory care services in such subdivisions; and
p.001443: (III) the health and support services per- sonnel needs of such subdivisions; and
p.001443: (ii) establish an HIV health services planning council in accordance with subsection (b).
p.001443: (B) LOCAL POLITICAL SUBDIVISION.—The political sub- divisions referred to in subparagraph (A) are those
p.001443: polit- ical subdivisions in the eligible area—
p.001443: (i) that provide HIV-related health services; and
p.001443: (ii) for which the number of cases reported for purposes of section 2601(a) constitutes not less than
p.001443: 10 percent of the number of such cases reported for the eligible area.
p.001443: (b) HIV HEALTH SERVICES PLANNING COUNCIL.—
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001443:
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p.001443: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1444
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p.001443: January 30, 2020
p.001443:
p.001443: (1) ESTABLISHMENT.—To be eligible for assistance under this subpart, the chief elected official described
p.001443: in subsection (a)(1) shall establish or designate an HIV health services plan- ning council that shall reflect in
p.001443: its composition the demo- graphics of the population of individuals with HIV/AIDS in the eligible area involved,
p.001443: with particular consideration given to disproportionately affected and historically underserved groups and
p.001443: subpopulations. Nominations for membership on the coun- cil shall be identified through an open process and
p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
p.001443: (A) IN GENERAL.—In providing for a council for pur- poses of paragraph (1), a chief elected official
p.001443: receiving a grant under section 2601(a) may establish the council di- rectly or designate an existing entity
p.001443: to serve as the coun- cil, subject to subparagraph (B).
p.001443: (B) CONSIDERATION REGARDING DESIGNATION OF COUN- CIL.—In making a determination of whether to establish or
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: 1445
p.001445: PUBLIC HEALTH SERVICE ACT
p.001445: Sec. 2602
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p.001445: January 30, 2020
p.001445: designate a council under subparagraph (A), a chief elected official receiving a grant under section 2601(a)
p.001445: shall give priority to the designation of an existing entity that has demonstrated experience in planning
p.001445: for the HIV health care service needs within the eligible area and in the im- plementation of such plans
p.001445: in addressing those needs. Any existing entity so designated shall be expanded to include a broad
p.001445: representation of the full range of entities that provide such services within the geographic area to be
p.001445: served.
p.001445: (4) DUTIES.—The planning council established or des- ignated under paragraph (1) shall—
p.001445: (A) determine the size and demographics of the popu- lation of individuals with HIV/AIDS, as well as
p.001445: the size and demographics of the estimated population of individ- uals with HIV/AIDS who are unaware of their
p.001445: HIV status;
p.001445: (B) determine the needs of such population, with par- ticular attention to—
p.001445: (i) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services;
p.001445: (ii) disparities in access and services among af- fected subpopulations and historically underserved
p.001445: communities; and
p.001445: (iii) individuals with HIV/AIDS who do not know their HIV status;
p.001445: (C) establish priorities for the allocation of funds with- in the eligible area, including how best to meet each such
p.001445: priority and additional factors that a grantee should con- sider in allocating funds under a grant based on
p.001445: the—
p.001445: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under subpara- graph (A)) and
p.001445: the needs of such population (as deter- mined under subparagraph (B));
p.001445: (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and
p.001445: interventions, to the extent that data are reasonably available;
p.001445: (iii) priorities of the communities with HIV/AIDS for whom the services are intended;
p.001445: (iv) coordination in the provision of services to such individuals with programs for HIV prevention and
p.001445: for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for
p.001445: such abuse;
p.001445: (v) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001445: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001445: Act to cover health care costs of eligible individuals and families with HIV/AIDS; and
p.001445: (vi) capacity development needs resulting from disparities in the availability of HIV-related services
p.001445: in historically underserved communities;
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1446
p.001445:
p.001445: (D) develop a comprehensive plan for the organization and delivery of health and support services described in
p.001445: section 2604 that—
p.001445: (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services
p.001445: and for informing the individuals of and ena- bling the individuals to utilize the services, giving par- ticular
p.001445: attention to eliminating disparities in access and services among affected subpopulations and his- torically
p.001445: underserved communities, and including dis- crete goals, a timetable, and an appropriate allocation of funds;
p.001445: (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (in- cluding
p.001445: outreach and early intervention) and for the prevention and treatment of substance abuse (includ- ing
p.001445: programs that provide comprehensive treatment services for such abuse);
p.001445: (iii) is compatible with any State or local plan for the provision of services to individuals with HIV/AIDS; and
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p.001445: (iv) includes a strategy, coordinated as appro- priate with other community strategies and efforts, in-
p.001445: cluding discrete goals, a timetable, and appropriate funding, for identifying individuals with HIV/AIDS
p.001445: who do not know their HIV status, making such indi- viduals aware of such status, and enabling such indi-
p.001445: viduals to use the health and support services de- scribed in section 2604, with particular attention to re-
p.001445: ducing barriers to routine testing and disparities in access and services among affected subpopulations and
p.001445: historically underserved communities;
p.001445: (E) assess the efficiency of the administrative mecha- nism in rapidly allocating funds to the areas of
p.001445: greatest need within the eligible area, and at the discretion of the planning council, assess the
p.001445: effectiveness, either directly or through contractual arrangements, of the services offered in meeting the
p.001445: identified needs;
p.001445: (F) participate in the development of the statewide co- ordinated statement of need initiated by the State
p.001445: public health agency responsible for administering grants under part B;
p.001445: (G) establish methods for obtaining input on commu- nity needs and priorities which may include public
p.001445: meet- ings (in accordance with paragraph (7)), conducting focus groups, and convening ad-hoc panels; and
p.001445: (H) coordinate with Federal grantees that provide HIV-related services within the eligible area.
p.001445: (5) CONFLICTS OF INTEREST.—
p.001445: (A) IN GENERAL.—The planning council under para- graph (1) may not be directly involved in the
p.001445: administra- tion of a grant under section 2601(a). With respect to com- pliance with the preceding sentence, the
p.001445: planning council may not designate (or otherwise be involved in the selec-
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001447: 1447
p.001447: PUBLIC HEALTH SERVICE ACT
p.001447: Sec. 2602
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p.001447: tion of) particular entities as recipients of any of the amounts provided in the grant.
p.001447: (B) REQUIRED AGREEMENTS.—An individual may serve on the planning council under paragraph (1) only if the in-
p.001447: dividual agrees that if the individual has a financial inter- est in an entity, if the individual is an employee of a
p.001447: public or private entity, or if the individual is a member of a pub- lic or private organization, and such entity or
p.001447: organization is seeking amounts from a grant under section 2601(a), the individual will not, with respect to the
p.001447: purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the
p.001447: process of selecting entities to receive such amounts for such purpose.
p.001447: (C) COMPOSITION OF COUNCIL.—The following applies regarding the membership of a planning council under
p.001447: paragraph (1):
p.001447: (i) Not less than 33 percent of the council shall be individuals who are receiving HIV-related services
p.001447: pursuant to a grant under section 2601(a), are not offi- cers, employees, or consultants to any entity that re-
p.001447: ceives amounts from such a grant, and do not rep- resent any such entity, and reflect the demographics of the
p.001447: population of individuals with HIV/AIDS as deter- mined under paragraph (4)(A). For purposes of the preceding
p.001447: sentence, an individual shall be considered to be receiving such services if the individual is a par- ent of, or a
p.001447: caregiver for, a minor child who is receiv- ing such services.
p.001447: (ii) With respect to membership on the planning council, clause (i) may not be construed as having any effect on
p.001447: entities that receive funds from grants under any of parts B through F but do not receive funds from grants
p.001447: under section 2601(a), on officers or em- ployees of such entities, or on individuals who rep- resent
p.001447: such entities.
p.001447: (6) GRIEVANCE PROCEDURES.—A planning council under paragraph (1) shall develop procedures for addressing
p.001447: griev- ances with respect to funding under this subpart, including procedures for submitting grievances that
p.001447: cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning
p.001447: council and be consistent with the re- quirements of subsection (c).
p.001447: (7) PUBLIC DELIBERATIONS.—With respect to a planning council under paragraph (1), the following applies:
p.001447: (A) The council may not be chaired solely by an em- ployee of the grantee under section 2601(a).
p.001447: (B) In accordance with criteria established by the Sec- retary:
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p.001447: (i) The meetings of the council shall be open to the public and shall be held only after adequate notice to
p.001447: the public.
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p.001447: (c) 3 GRIEVANCE PROCEDURES.—
p.001447: (1) FEDERAL RESPONSIBILITY.—
p.001447: (A) MODELS.—The Secretary shall, through a process that includes consultations with grantees under this
p.001447: sub- part and public and private experts in grievance proce- dures, arbitration, and mediation, develop model
p.001447: grievance procedures that may be implemented by the planning council under subsection (b)(1) and
p.001447: grantees under this subpart. Such model procedures shall describe the ele- ments that must be addressed
p.001447: in establishing local griev- ance procedures and provide grantees with flexibility in the design of such
p.001447: local procedures.
p.001447: (B) REVIEW.—The Secretary shall review grievance procedures established by the planning council and
p.001447: grant- ees under this subpart to determine if such procedures are adequate. In making such a determination, the
p.001447: Secretary shall assess whether such procedures permit legitimate grievances to be filed, evaluated, and resolved
p.001447: at the local level.
p.001447: (2) GRANTEES.—To be eligible to receive funds under this subpart, a grantee shall develop grievance procedures
p.001447: that are determined by the Secretary to be consistent with the model procedures developed under paragraph
p.001447: (1)(A). Such procedures shall include a process for submitting grievances to binding ar- bitration.
p.001447: (d) PROCESS FOR ESTABLISHING ALLOCATION PRIORITIES.— Promptly after the date of the submission of the
p.001447: report required in section 501(b) of the Ryan White CARE Act Amendments of 2000 4 (relating to the relationship between
p.001447: epidemiological measures and health care for certain individuals with HIV/AIDS), the Secretary, in
p.001447: consultation with planning councils and entities that receive amounts from grants under section 2601(a) or
p.001447: 2611, shall develop epidemiologic measures—
p.001447: (1) for establishing the number of individuals living with HIV/AIDS who are not receiving HIV-related
p.001447: health services; and
p.001447: (2) for carrying out the duties under subsection (b)(4) and section 2617(b).
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p.001447: January 30, 2020
p.001447: 3 Subsection (c) was added by an amendment to subsection (b). Section 3(b)(1)(F) of Public Law 104–146 (110 Stat.
p.001447: 1348) provided that subsection (b) of section 2602 is amended ‘‘by adding at the end thereof the
p.001447: following:’’, and then added paragraphs (5) and (6) and subsection (c). 4 Public Law 106–345 (114 Stat.
p.001447: 1352). Section 501(d)(2) of such Law requires that the report be submitted not later than 2 years after the date of the
p.001447: enactment of the Law, which was en-
p.001447: acted October 20, 2000.
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p.001449: 1449
p.001449: PUBLIC HEALTH SERVICE ACT
p.001449: Sec. 2603
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p.001449: (e) TRAINING GUIDANCE AND MATERIALS.—The Secretary shall provide to each chief elected official receiving a grant
p.001449: under section 2601(a) guidelines and materials for training members of the plan- ning council under paragraph (1)
p.001449: regarding the duties of the coun- cil.
p.001449: SEC. 2603. ø300ff–13¿ TYPE AND DISTRIBUTION OF GRANTS.
p.001449: (a) GRANTS BASED ON RELATIVE NEED OF AREA.—
p.001449: (1) IN GENERAL.—In carrying out section 2601(a), the Sec- retary shall make a grant for each eligible
p.001449: area for which an application under section 2605(a) has been approved. Each such grant shall be made in an
p.001449: amount determined in accord- ance with paragraph (3).
p.001449: (2) EXPEDITED DISTRIBUTION.—Not later than 60 days after an appropriation becomes available to carry out
p.001449: this subpart for a fiscal year, the Secretary shall, except in the case of waiv- ers granted under section 2605(c),
p.001449: disburse 662⁄3 percent of the amount made available under section 2610(b) for carrying out this subpart for
p.001449: such fiscal year through grants to eligible areas under section 2601(a), in accordance with paragraphs (3) and
p.001449: (4).
p.001449: (3) AMOUNT OF GRANT.—
p.001449: (A) IN GENERAL.—Subject to the extent of amounts made available in appropriations Acts, a grant made for
p.001449: purposes of this paragraph to an eligible area shall be made in an amount equal to the product of—
p.001449: (i) an amount equal to the amount available for distribution under paragraph (2) for the fiscal year in-
p.001449: volved; and
p.001449: (ii) the percentage constituted by the ratio of the distribution factor for the eligible area to the
p.001449: sum of the respective distribution factors for all eligible areas;
p.001449: which product shall then, as applicable, be increased under paragraph (4).
p.001449: (B) DISTRIBUTION FACTOR.—For purposes of subpara- graph (A)(ii), the term ‘‘distribution factor’’
p.001449: means an amount equal to the estimated number of living cases of AIDS 5 in the eligible area involved,
p.001449: as determined under subparagraph (C).
p.001449: (C) LIVING CASES OF HIV/AIDS.—
p.001449: (i) REQUIREMENT OF NAMES-BASED REPORTING.— Except as provided in clause (ii), the number deter- mined
p.001449: under this subparagraph for an eligible area for a fiscal year for purposes of subparagraph (B) is the number
p.001449: of living names-based cases of HIV/AIDS that, as of December 31 of the most recent calendar year for which such data
p.001449: is available, have been reported to and confirmed by the Director of the Centers for Dis- ease Control
p.001449: and Prevention.
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p.001449: January 30, 2020
p.001449: 5 Section 102(b)(1) of Public Law 109–415 provides as follows:
p.001449: (1) in subparagraph (B), by striking ‘‘estimated living cases of acquired immune deficiency syndrome’’ and inserting
p.001449: ‘‘living cases of HIV/AIDS (reported to and confirmed by the Direc- tor of the Centers for Disease Control and
p.001449: Prevention)’’; and
p.001449: Such amendment could not be executed because the words ‘‘number of’’ probably should ap- pear before
p.001449: ‘‘living cases’’ in the matter purported to be struck.
p.001449: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001449: (ii) TRANSITION PERIOD; EXEMPTION REGARDING NON-AIDS CASES.—For each of the fiscal years 2007 through
p.001449: 2012, an eligible area is, subject to clauses
p.001449: (iii) through (v), exempt from the requirement under clause (i) that living names-based non-AIDS cases of
p.001449: HIV be reported unless—
p.001449: (I) a system was in operation as of December 31, 2005, that provides sufficiently accurate and reliable
p.001449: names-based reporting of such cases throughout the State in which the area is located, subject to clause
p.001449: (viii); or
p.001449: (II) no later than the beginning of fiscal year 2008 or a subsequent fiscal year through fiscal year
p.001449: 2012, the Secretary, in consultation with the chief executive of the State in which the area is lo- cated, determines
p.001449: that a system has become oper- ational in the State that provides sufficiently ac- curate and reliable
p.001449: names-based reporting of such cases throughout the State.
p.001449: (iii) REQUIREMENTS FOR EXEMPTION FOR FISCAL YEAR 2007.—For fiscal year 2007, an exemption under clause
p.001449: (ii) for an eligible area applies only if, by Octo- ber 1, 2006—
p.001449: (I)(aa) the State in which the area is located had submitted to the Secretary a plan for making the transition
p.001449: to sufficiently accurate and reliable names-based reporting of living non-AIDS cases of HIV; or
p.001449: (bb) all statutory changes necessary to provide for sufficiently accurate and reliable reporting of such cases
p.001449: had been made; and
p.001449: (II) the State had agreed that, by April 1, 2008, the State will begin accurate and reliable names-based
p.001449: reporting of such cases, except that such agreement is not required to provide that, as of such date, the
p.001449: system for such reporting be fully sufficient with respect to accuracy and reli- ability throughout the
p.001449: area.
p.001449: (iv) REQUIREMENT FOR EXEMPTION AS OF FISCAL YEAR 2008.—For each of the fiscal years 2008 through
p.001449: 2012, an exemption under clause (ii) for an eligible area applies only if, as of April 1, 2008, the
p.001449: State in which the area is located is substantially in compli- ance with the agreement under clause (iii)(II).
p.001449: (v) PROGRESS TOWARD NAMES-BASED REPORTING.— For fiscal year 2009 or a subsequent fiscal year, the Secretary
p.001449: may terminate an exemption under clause
p.001449: (ii) for an eligible area if the State in which the area is located submitted a plan under clause
p.001449: (iii)(I)(aa) and the Secretary determines that the State is not substantially following the plan.
p.001449: (vi) COUNTING OF CASES IN AREAS WITH EXEMP- TIONS.—
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p.001451: (I) IN GENERAL.—With respect to an eligible area that is under a reporting system for living non-AIDS
p.001451: cases of HIV that is not names-based (referred to in this subparagraph as ‘‘code-based reporting’’), the
p.001451: Secretary shall, for purposes of this subparagraph, modify the number of such cases reported for the eligible
p.001451: area in order to ad- just for duplicative reporting in and among sys- tems that use code-based reporting.
p.001451: (II) ADJUSTMENT RATE.—The adjustment rate under subclause (I) for an eligible area shall be a reduction of 5
p.001451: percent for fiscal years before fiscal year 2012 (and 6 percent for fiscal year 2012) in the number of
p.001451: living non-AIDS cases of HIV re- ported for the area.
p.001451: (III) INCREASED ADJUSTMENT FOR CERTAIN AREAS PREVIOUSLY USING CODE-BASED REPORT- ING.—For
p.001451: purposes of this subparagraph for each of fiscal years 2010 through 2012, the Secretary shall deem the
p.001451: applicable number of living cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for
p.001451: Disease Control and Prevention to be 3 percent higher than the actual number if—
p.001451: (aa) for fiscal year 2007, such area was a transitional area;
p.001451: (bb) fiscal year 2007 was the first year in which the count of living non-AIDS cases of HIV in such area, for
p.001451: purposes of this section, was based on a names-based reporting sys- tem; and
p.001451: (cc) the amount of funding that such area received under this part for fiscal year 2007 was less than 70
p.001451: percent of the amount of funding (exclusive of funds that were identi- fied as being for purposes of
p.001451: the Minority AIDS Initiative) that such area received under such part for fiscal year 2006.
p.001451: (vii) MULTIPLE POLITICAL JURISDICTIONS.—With respect to living non-AIDS cases of HIV, if an eligible area is
p.001451: not entirely within one political jurisdiction and as a result is subject to more than one reporting
p.001451: system for purposes of this subparagraph:
p.001451: (I) Names-based reporting under clause (i) ap- plies in a jurisdictional portion of the area, or an exemption
p.001451: under clause (ii) applies in such portion (subject to applicable provisions of this subpara- graph), according
p.001451: to whether names-based report- ing or code-based reporting is used in such por- tion.
p.001451: (II) If under subclause (I) both names-based reporting and code-based reporting apply in the area, the
p.001451: number of code-based cases shall be re- duced under clause (vi).
p.001451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001451: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1452
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p.001451: January 30, 2020
p.001451:
p.001451: (viii) LIST OF ELIGIBLE AREAS MEETING STANDARD REGARDING DECEMBER 31, 2005.—
p.001451: (I) IN GENERAL.—If an eligible area or portion thereof is in a State specified in subclause (II), the eligible area or
p.001451: portion shall be considered to meet the standard described in clause (ii)(I). No other eligible area or portion
p.001451: thereof may be considered to meet such standard.
p.001451: (II) RELEVANT STATES.—For purposes of sub- clause (I), the States specified in this subclause are the
p.001451: following: Alaska, Alabama, Arkansas, Ar- izona, Colorado, Florida, Indiana, Iowa, Idaho, Kansas,
p.001451: Louisiana, Michigan, Minnesota, Mis- souri, Mississippi, North Carolina, North Dakota, Nebraska, New
p.001451: Jersey, New Mexico, New York, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah,
p.001451: Virginia, Wis- consin, West Virginia, Wyoming, Guam, and the Virgin Islands.
p.001451: (ix) RULES OF CONSTRUCTION REGARDING ACCEPT- ANCE OF REPORTS.—
p.001451: (I) CASES OF AIDS.—With respect to an eligible area that is subject to the requirement under clause (i)
p.001451: and is not in compliance with the re- quirement for names-based reporting of living non-AIDS cases
p.001451: of HIV, the Secretary shall, not- withstanding such noncompliance, accept reports of living cases of AIDS that
p.001451: are in accordance with such clause.
p.001451: (II) APPLICABILITY OF EXEMPTION REQUIRE- MENTS.—The provisions of clauses (ii) through
p.001451: (viii) may not be construed as having any legal ef- fect for fiscal year 2013 or any subsequent fiscal year,
p.001451: and accordingly, the status of a State for purposes of such clauses may not be considered after fiscal
p.001451: year 2012.
p.001451: (x) PROGRAM FOR DETECTING INACCURATE OR FRAUDULENT COUNTING.—The Secretary shall carry out a
p.001451: program to monitor the reporting of names- based cases for purposes of this subparagraph and to detect
p.001451: instances of inaccurate reporting, including fraudulent reporting.
p.001451: (xi) FUTURE FISCAL YEARS.—For fiscal years begin- ning with fiscal year 2013, determinations under this
p.001451: paragraph shall be based only on living names-based cases of HIV/AIDS with respect to the area involved.
p.001451: (D) CODE-BASED AREAS; LIMITATION ON INCREASE IN GRANT.—
p.001451: (i) IN GENERAL.—For each of the fiscal years 2007 through 2012, if code-based reporting (within the meaning
p.001451: of subparagraph (C)(vi)) applies in an eligible area or any portion thereof as of the beginning of the fiscal
p.001451: year involved, then notwithstanding any other provision of this paragraph, the amount of the grant
p.001451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001453: 1453
p.001453: PUBLIC HEALTH SERVICE ACT
p.001453: Sec. 2603
p.001453:
p.001453: pursuant to this paragraph for such area for such fis- cal year may not—
p.001453: (I) for fiscal year 2007, exceed by more than
p.001453: 5 percent the amount of the grant for the area that would have been made pursuant to this para- graph and
p.001453: paragraph (4) for fiscal year 2006 (as such paragraphs were in effect for such fiscal year) if
p.001453: paragraph (2) (as so in effect) had been applied by substituting ‘‘662⁄3 percent’’ for ‘‘50 per- cent’’; and
p.001453: (II) for each of the fiscal years 2008 through 2012, exceed by more than 5 percent the amount of the
p.001453: grant pursuant to this paragraph and para- graph (4) for the area for the preceding fiscal year.
p.001453: (ii) USE OF AMOUNTS INVOLVED.—For each of the fiscal years 2007 through 2012, amounts available as a
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p.001453: January 30, 2020
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p.001453: section for the fiscal year, other than grants for eligi- ble areas for which increases under
p.001453: subparagraph (A) apply. A reduction under the preceding sentence may not be made in an amount that would result
p.001453: in the eli- gible area involved becoming eligible for such an in- crease.
p.001453: (C) LIMITATION.—This paragraph may not be con- strued as having any applicability after fiscal year 2013.
p.001453: (b) SUPPLEMENTAL GRANTS.—
p.001453: (1) IN GENERAL.—Subject to subsection (a)(4)(B)(i) and sec- tion 2610(d), the Secretary shall disburse the
p.001453: remainder of amounts not disbursed under section 2603(a)(2) for such fiscal year for the purpose of making grants
p.001453: under section 2601(a) to eligible areas whose application under section 2605(b)—
p.001453: (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) and the
p.001453: plan for utilization of such funds;
p.001453: (B) demonstrates the need in such area, on an objec- tive and quantified basis, for supplemental financial
p.001453: assist- ance to combat the HIV epidemic;
p.001453: (C) demonstrates the existing commitment of local re- sources of the area, both financial and in-kind, to com-
p.001453: bating the HIV epidemic;
p.001453: (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is
p.001453: im- mediately responsive and cost effective;
p.001453: (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of
p.001453: AIDS including appropriate allocations for services for infants, children, youth, women, and families with
p.001453: HIV/AIDS;
p.001453: (F) demonstrates the inclusiveness of affected commu- nities and individuals with HIV/AIDS;
p.001453: (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment
p.001453: and the statewide coordinated statement of need;
p.001453: (H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most
p.001453: recent grant year under subsection (a) for which data is available, more than 5 percent of grant funds under such
p.001453: subsection canceled, offset under subsection (c)(4), or covered by any waivers under subsection (c)(3); and
p.001453: (I) demonstrates success in identifying individuals with HIV/AIDS as described in clauses (i) through
p.001453: (iii) of paragraph (2)(A).
p.001453: (2) AMOUNT OF GRANT.—
p.001453: (A) IN GENERAL.—The amount of each grant made for purposes of this subsection shall be determined by the Sec-
p.001453: retary based on a weighting of factors under paragraph (1), with demonstrated need under subparagraph (B) of
p.001453: such paragraph counting one-third, and demonstrated success in identifying individuals with HIV/AIDS who do not
p.001453: know their HIV status and making them aware of such status counting one-third. In making such
p.001453: determination, the Secretary shall consider—
p.001453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001455: PUBLIC HEALTH SERVICE ACT
p.001455: Sec. 2603
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p.001455: January 30, 2020
p.001455: (i) the number of individuals who have been test- ed for HIV/AIDS;
p.001455: (ii) of those individuals described in clause (i), the number of individuals who tested for HIV/AIDS who are
p.001455: made aware of their status, including the number who test positive; and
p.001455: (iii) of those individuals described in clause (ii), the number who have been referred to appropriate
p.001455: treatment and care.
p.001455: (B) DEMONSTRATED NEED.—The factors considered by the Secretary in determining whether an eligible area has a
p.001455: demonstrated need for purposes of paragraph (1)(B) may include any or all of the following:
p.001455: (i) The unmet need for such services, as deter- mined under section 2602(b)(4) or other community input
p.001455: process as defined under section 2609(d)(1)(A).
p.001455: (ii) An increasing need for HIV/AIDS-related serv- ices, including relative rates of increase in the number of cases of
p.001455: HIV/AIDS.
p.001455: (iii) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging sub-
p.001455: populations.
p.001455: (iv) The current prevalence of HIV/AIDS.
p.001455: (v) Relevant factors related to the cost and com- plexity of delivering health care to individuals with
p.001455: HIV/AIDS in the eligible area.
p.001455: (vi) The impact of co-morbid factors, including co- occurring conditions, determined relevant by the Sec-
p.001455: retary.
p.001455: (vii) The prevalence of homelessness.
p.001455: (viii) The prevalence of individuals described under section 2602(b)(2)(M).
p.001455: (ix) The relevant factors that limit access to health care, including geographic variation, adequacy
p.001455: of health insurance coverage, and language barriers.
p.001455: (x) The impact of a decline in the amount received pursuant to subsection (a) on services available to all
p.001455: individuals with HIV/AIDS identified and eligible under this title.
p.001455: (C) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this subsection to an eligible area to
p.001455: address the decline or disruption of all EMA-provided serv- ices related to the decline in the amounts received
p.001455: pursu- ant to subsection (a) consistent with the grant award for the eligible area for fiscal year 2006, to
p.001455: the extent that the factor under subparagraph (B)(x) (relating to a decline in funding) applies to the eligible
p.001455: area.
p.001455: (D) INCREASED ADJUSTMENT FOR CERTAIN AREAS PRE- VIOUSLY USING CODE-BASED REPORTING.—For purposes of this
p.001455: subsection for each of fiscal years 2010 through 2012, the Secretary shall deem the applicable number of living
p.001455: cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for Disease Control and
p.001455: Preven- tion to be 3 percent higher than the actual number if the
p.001455: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001455: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1456
p.001455: conditions described in items (aa) through (cc) of sub- section (a)(3)(C)(vi)(III) are all satisfied.
p.001455: (3) REMAINDER OF AMOUNTS.—In determining the amount of funds to be obligated under paragraph (1),
p.001455: the Secretary shall include amounts that are not paid to the eligible areas under expedited procedures
p.001455: under section 2603(a)(2) as a re- sult of—
p.001455: (A) the failure of any eligible area to submit an appli- cation under section 2605(c); or
p.001455: (B) any eligible area informing the Secretary that such eligible area does not intend to expend the full
p.001455: amount of its grant under such section.
p.001455: (4) FAILURE TO SUBMIT.—
p.001455: (A) IN GENERAL.—The failure of an eligible area to submit an application for an expedited grant under section
p.001455: 2603(a)(2) shall not result in such area being ineligible for a grant under this subsection.
p.001455: (B) APPLICATION.—The application of an eligible area submitted under section 2605(b) shall contain the
p.001455: assur- ances required under subsection (a) of such section if such eligible area fails to submit an application for an
p.001455: expedited grant under section 2603(a)(2).
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p.001457: was 5 percent or less.
p.001457: (ii) RELATION TO INCREASES IN GRANT.—A reduc- tion under clause (i) for an eligible area for a fiscal
p.001457: year may not be taken into account in applying sub- section (a)(4) with respect to the area for the
p.001457: subse- quent fiscal year.
p.001457: (4) AUTHORITY REGARDING ADMINISTRATION OF PROVI- SIONS.—In administering paragraphs (2) and (3)
p.001457: with respect to the unobligated balance of an eligible area, the Secretary may elect to reduce the
p.001457: amount of future grants to the area under subsection (a) or (b), as applicable, by the amount of any such
p.001457: unobligated balance in lieu of cancelling such amount as provided for in paragraph (2) or (3)(A). In
p.001457: such case, the Sec- retary may permit the area to use such unobligated balance for purposes of any such future
p.001457: grant. An amount equal to such reduction shall be available for use as additional amounts for grants
p.001457: pursuant to subsection (b), subject to subsection (a)(4) and section 2610(d)(2). Nothing in this paragraph shall
p.001457: be con- strued to affect the authority of the Secretary under para- graphs (2) and (3), including the
p.001457: authority to grant waivers under paragraph (3)(A). The reduction in future grants author- ized under this
p.001457: paragraph shall be notwithstanding the pen- alty required under paragraph (3)(D) with respect to unobli-
p.001457: gated funds.
p.001457: (d) COMPLIANCE WITH PRIORITIES OF HIV PLANNING COUN-
p.001457: CIL.—Notwithstanding any other provision of this subpart, the Sec- retary, in carrying out section 2601(a), may
p.001457: not make any grant under subsection (a) or (b) to an eligible area unless the application submitted by such area
p.001457: under section 2605 for the grant involved demonstrates that the grants made under subsections (a) and
p.001457: (b) to the area for the preceding fiscal year (if any) were expended in accordance with the priorities
p.001457: applicable to such year that were es- tablished, pursuant to section 2602(b)(4)(C), by the planning coun- cil serving
p.001457: the area.
p.001457: (e) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001457: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001457: shall include information detail- ing—
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p.001457: January 30, 2020
p.001457: (1) the total amount of supplemental funds available under this section for the year involved;
p.001457: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of subsection (a)(4);
p.001457: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001459: 1459
p.001459: PUBLIC HEALTH SERVICE ACT
p.001459: Sec. 2604
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p.001459: (3) the amount of supplemental funds disbursed pursuant to subsection (b)(2)(C);
p.001459: (4) the disbursement of the remainder of the supplemental funds after taking into account the uses described in
p.001459: para- graphs (2) and (3); and
p.001459: (5) the rationale used for the amount of funds disbursed as described under paragraphs (2), (3), and (4).
p.001459: SEC. 2604. ø300ff–14¿ USE OF AMOUNTS.
p.001459: (a) REQUIREMENTS.—The Secretary may not make a grant under section 2601(a) to the chief elected official
p.001459: of an eligible area unless such political subdivision agrees that—
p.001459: (1) subject to paragraph (2), the allocation of funds and services within the eligible area will be
p.001459: made in accordance with the priorities established, pursuant to section 2602(b)(4)(C), by the
p.001459: HIV health services planning council that serves such eligible area;
p.001459: (2) funds provided under section 2601 will be expended only for—
p.001459: (A) core medical services described in subsection (c);
p.001459: (B) support services described in subsection (d); and
p.001459: (C) administrative expenses described in subsection (h); and
p.001459: (3) the use of such funds will comply with the require- ments of this section.
p.001459: (b) DIRECT FINANCIAL ASSISTANCE TO APPROPRIATE ENTITIES.—
p.001459: (1) IN GENERAL.—The chief elected official of an eligible area shall use amounts from a grant under section
p.001459: 2601 to pro- vide direct financial assistance to entities described in para- graph (2) for the purpose of
p.001459: providing core medical services and support services.
p.001459: (2) APPROPRIATE ENTITIES.—Direct financial assistance may be provided under paragraph (1) to public or
p.001459: nonprofit pri- vate entities, or private for-profit entities if such entities are the only available provider
p.001459: of quality HIV care in the area.
p.001459: (c) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001459: (1) IN GENERAL.—With respect to a grant under section 2601 for an eligible area for a grant year, the chief
p.001459: elected offi- cial of the area shall, of the portion of the grant remaining after reserving amounts for
p.001459: purposes of paragraphs (1) and (5)(B)(i) of subsection (h), use not less than 75 percent to pro- vide
p.001459: core medical services that are needed in the eligible area for individuals with HIV/AIDS who are
p.001459: identified and eligible under this title (including services regarding the co-occurring conditions of the
p.001459: individuals).
p.001459: (2) WAIVER.—
p.001459: (A) IN GENERAL.—The Secretary shall waive the appli- cation of paragraph (1) with respect to a chief elected offi- cial
p.001459: for a grant year if the Secretary determines that, with- in the eligible area involved—
p.001459: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001459: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001459: this title.
p.001459: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing the chief elected official of an eligible area that a grant
p.001459: under section 2601 is being made for the area for a grant year, the Secretary shall inform the
p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
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p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
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p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001461: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001461: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, the
p.001461: chief elected official of an eligible area, in accordance with the established priorities of the planning
p.001461: council, shall for each of such populations in the eligible area use, from the grants made for the area under
p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
p.001461: involved (infants, chil- dren, youth, or women in such area) with HIV/AIDS to the general population in
p.001461: such area of individuals with HIV/AIDS.
p.001461: (2) WAIVER.—With respect to the population involved, the Secretary may provide to the chief elected official of
p.001461: an eligible area a waiver of the requirement of paragraph (1) if such offi- cial demonstrates to the satisfaction
p.001461: of the Secretary that the population is receiving HIV-related health services through the State medicaid program
p.001461: under title XIX of the Social Security Act, the State children’s health insurance program under title XXI
p.001461: of such Act, or other Federal or State programs.
p.001461: (g) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.001461: (1) PROVISION OF SERVICE.—Subject to paragraph (2), the Secretary may not make a grant under section 2601(a) for
p.001461: the provision of services under this section in a State unless, in the case of any such service that is available
p.001461: pursuant to the State plan approved under title XIX of the Social Security Act for the State—
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p.001461: (A) the political subdivision involved will provide the service directly, and the political subdivision
p.001461: has entered into a participation agreement under the State plan and is qualified to receive payments under such plan;
p.001461: or
p.001461: (B) the political subdivision will enter into an agree- ment with a public or nonprofit private entity under
p.001461: which the entity will provide the service, and the entity has en- tered into such a participation
p.001461: agreement and is qualified to receive such payments.
p.001461: (2) WAIVER.—
p.001461: (A) IN GENERAL.—In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the pro-
p.001461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: vision of services, the requirement established in such paragraph shall be waived by the HIV health
p.001461: services planning council for the eligible area if the entity does not, in providing health care services, impose
p.001461: a charge or ac- cept reimbursement available from any third-party payor, including reimbursement under any
p.001461: insurance policy or under any Federal or State health benefits program.
p.001461: (B) DETERMINATION.—A determination by the HIV health services planning council of whether an entity
p.001461: re- ferred to in subparagraph (A) meets the criteria for a waiv- er under such subparagraph shall be made without
p.001461: regard to whether the entity accepts voluntary donations for the purpose of providing services to the public.
p.001461: (h) ADMINISTRATION.—
p.001461: (1) LIMITATION.—The chief elected official of an eligible area shall not use in excess of 10 percent of amounts
p.001461: received under a grant under this subpart for administrative expenses.
p.001461: (2) ALLOCATIONS BY CHIEF ELECTED OFFICIAL.—In the case of entities and subcontractors to which the chief elected
p.001461: official of an eligible area allocates amounts received by the official under a grant under this subpart, the
p.001461: official shall ensure that, of the aggregate amount so allocated, the total of the expendi- tures by such entities for
p.001461: administrative expenses does not ex- ceed 10 percent (without regard to whether particular entities expend more
p.001461: than 10 percent for such expenses).
p.001461: (3) ADMINISTRATIVE ACTIVITIES.—For purposes of para- graph (1), amounts may be used for
p.001461: administrative activities that include—
p.001461: (A) routine grant administration and monitoring ac- tivities, including the development of applications for part
p.001461: A funds, the receipt and disbursal of program funds, the development and establishment of reimbursement
p.001461: and ac- counting systems, the development of a clinical quality management program as described in
p.001461: paragraph (5), the preparation of routine programmatic and financial reports, and compliance with grant
p.001461: conditions and audit require- ments; and
p.001461: (B) all activities associated with the grantee’s contract award procedures, including the activities carried out
p.001461: by the HIV health services planning council as established under section 2602(b), the development of requests
p.001461: for pro- posals, contract proposal review activities, negotiation and awarding of contracts, monitoring of
p.001461: contracts through telephone consultation, written documentation or onsite visits, reporting on contracts,
p.001461: and funding reallocation ac- tivities.
p.001461: (4) SUBCONTRACTOR ADMINISTRATIVE ACTIVITIES.—For the purposes of this subsection, subcontractor
p.001461: administrative ac- tivities include—
p.001461: (A) usual and recognized overhead activities, including established indirect rates for agencies;
p.001461: (B) management oversight of specific programs funded under this title; and
p.001461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001463: 1463
p.001463: PUBLIC HEALTH SERVICE ACT
p.001463: Sec. 2605
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p.001463: (C) other types of program support such as quality as- surance, quality control, and related activities.
p.001463: (5) CLINICAL QUALITY MANAGEMENT.—
p.001463: (A) REQUIREMENT.—The chief elected official of an eli- gible area that receives a grant under this subpart
p.001463: shall provide for the establishment of a clinical quality manage- ment program to assess the extent to which
p.001463: HIV health services provided to patients under the grant are con- sistent with the most recent Public
p.001463: Health Service guide- lines for the treatment of HIV/AIDS and related opportun- istic infection, and as
p.001463: applicable, to develop strategies for ensuring that such services are consistent with the guide- lines for
p.001463: improvement in the access to and quality of HIV health services.
p.001463: (B) USE OF FUNDS.—
p.001463: (i) IN GENERAL.—From amounts received under a grant awarded under this subpart for a fiscal year, the chief
p.001463: elected official of an eligible area may use for ac- tivities associated with the clinical quality manage- ment
p.001463: program required in subparagraph (A) not to ex- ceed the lesser of—
p.001463: (I) 5 percent of amounts received under the grant; or
p.001463: (II) $3,000,000.
p.001463: (ii) RELATION TO LIMITATION ON ADMINISTRATIVE EXPENSES.—The costs of a clinical quality manage- ment
p.001463: program under subparagraph (A) may not be considered administrative expenses for purposes of the limitation
p.001463: established in paragraph (1).
p.001463: (i) CONSTRUCTION.—A chief elected official may not use amounts received under a grant awarded under
p.001463: this subpart to purchase or improve land, or to purchase, construct, or perma- nently improve (other
p.001463: than minor remodeling) any building or other facility, or to make cash payments to intended recipients
p.001463: of services.
p.001463: SEC. 2605. ø300ff–15¿ APPLICATION.
p.001463: (a) IN GENERAL.—To be eligible to receive a grant under sec- tion 2601, an eligible area shall prepare
p.001463: and submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001463: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001463: shall require, in- cluding assurances adequate to ensure—
p.001463: (1)(A) that funds received under a grant awarded under this subpart will be utilized to supplement not
p.001463: supplant State funds made available in the year for which the grant is award- ed to provide HIV-related
p.001463: services as described in section 2604(b)(1);
p.001463: (B) that the political subdivisions within the eligible area will maintain the level of expenditures by
p.001463: such political sub- divisions for HIV-related services as described in section 2604(b)(1) at a level
p.001463: that is equal to the level of such expendi- tures by such political subdivisions for the preceding fiscal year;
p.001463: and
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
p.001463: (B) by an entity that provides health services on a pre- paid basis;
p.001463: (7) to the maximum extent practicable, that—
p.001463: (A) HIV health care and support services provided with assistance made available under this subpart will be
p.001463: provided without regard—
p.001463: (i) to the ability of the individual to pay for such services; and
p.001463: (ii) to the current or past health condition of the individual to be served;
p.001463: (B) such services will be provided in a setting that is accessible to low-income individuals with
p.001463: HIV-disease; and
p.001463: (C) a program of outreach will be provided to low-in- come individuals with HIV-disease to inform such
p.001463: individ- uals of such services;
p.001463: (8) that the applicant has participated, or will agree to participate, in the statewide coordinated
p.001463: statement of need process where it has been initiated by the State public health
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001465: 1465
p.001465: PUBLIC HEALTH SERVICE ACT
p.001465: Sec. 2605
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p.001465: agency responsible for administering grants under part B, and ensure that the services provided under the
p.001465: comprehensive plan are consistent with the statewide coordinated statement of need;
p.001465: (9) that the eligible area has procedures in place to ensure that services provided with funds received under
p.001465: this subpart meet the criteria specified in section 2604(b)(1); and
p.001465: (10) that the chief elected official will submit to the lead State agency under section 2617(b)(4),
p.001465: audits, consistent with Office of Management and Budget circular A133, regarding funds expended in
p.001465: accordance with this subpart every 2 years and shall include necessary client-based data to compile unmet need
p.001465: calculations and Statewide coordinated statements of need process.
p.001465: (b) APPLICATION.—An eligible area that desires to receive a grant under section 2603(b) shall prepare and
p.001465: submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001465: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001465: shall require, in- cluding the information required under such subsection and infor- mation concerning—
p.001465: (1) the number of individuals to be served within the eligi- ble area with assistance provided under the grant,
p.001465: including the identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of section
p.001465: 2603(b)(2)(A);
p.001465: (2) demographic data on the population of such individ- uals;
p.001465: (3) the average cost of providing each category of HIV-re- lated health services and the extent to which such
p.001465: cost is paid by third-party payors;
p.001465: (4) the aggregate amounts expended for each such category of services;
p.001465: (5) the manner in which the expected expenditures are re- lated to the planning process for States that receive
p.001465: funding under part B (including the planning process described in sec- tion 2617(b)); and
p.001465: (6) the expected expenditures and how those expenditures will improve overall client outcomes, as
p.001465: described under the State plan under section 2617(b), and through additional out- comes measures as
p.001465: identified by the HIV health services plan- ning council under section 2602(b).
p.001465: (c) SINGLE APPLICATION AND GRANT AWARD.—
p.001465: (1) APPLICATION.—The Secretary may phase in the use of a single application that meets the requirements of
p.001465: subsections
p.001465: (a) and (b) of section 2603 with respect to an eligible area that desires to receive grants under section 2603
p.001465: for a fiscal year.
p.001465: (2) GRANT AWARD.—The Secretary may phase in the awarding of a single grant to an eligible area that
p.001465: submits an approved application under paragraph (1) for a fiscal year.
p.001465: (d) DATE CERTAIN FOR SUBMISSION.—
p.001465: (1) REQUIREMENT.—Except as provided in paragraph (2), to be eligible to receive a grant under section 2601(a) for a
p.001465: fiscal year, an application under subsection (a) shall be submitted
p.001465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001467: Sec. 2607
p.001467:
p.001467: tity receiving assistance under this subpart may, in the case of individuals subject to a charge for purposes of
p.001467: such para- graph—
p.001467: (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal
p.001467: charge for the provision of services, subject to the provisions of such paragraph regarding public
p.001467: schedules and regarding limitations on the maximum amount of charges; and
p.001467: (B) take into consideration the medical expenses of in- dividuals in assessing the amount of the charge, subject to
p.001467: such provisions.
p.001467: (3) APPLICABILITY OF LIMITATION ON AMOUNT OF CHARGE.— The Secretary may not make a grant under section 2601 to an
p.001467: eligible area unless the eligible area agrees that the limitations established in subparagraphs (C), (D) and (E) of
p.001467: paragraph (1) regarding the imposition of charges for services applies to the annual aggregate of charges
p.001467: imposed for such services, without regard to whether they are characterized as enrollment fees, premiums,
p.001467: deductibles, cost sharing, copayments, coinsurance, or other charges.
p.001467: (4) WAIVER REGARDING SECONDARY AGREEMENTS.—The re- quirements established in paragraphs (1) through (3)
p.001467: shall be waived in accordance with section 2604(d)(2).
p.001467: SEC. 2606. ø300ff–16¿ TECHNICAL ASSISTANCE.
p.001467: The Administrator of the Health Resources and Services Ad- ministration shall, beginning on the date of
p.001467: enactment of this title, provide technical assistance, including assistance from other grant- ees, contractors or
p.001467: subcontractors under this title to assist newly eligible metropolitan areas in the establishment of HIV
p.001467: health services planning councils and, to assist entities in complying with the requirements of this subpart in order
p.001467: to make such entities eli- gible to receive a grant under this subpart. The Administrator may make planning grants
p.001467: available to metropolitan areas, in an amount not to exceed $75,000 for any metropolitan area, projected to
p.001467: be eligible for funding under section 2601 in the following fiscal year. Such grant amounts shall be deducted from the
p.001467: first year for- mula award to eligible areas accepting such grants. Not to exceed 1 percent of the amount
p.001467: appropriated for a fiscal year under section 2677 for grants under part A may be used to carry out this section.
p.001467: SEC. 2607. ø300ff–17¿ DEFINITIONS.
p.001467: For purposes of this subpart:
p.001467: (1) ELIGIBLE AREA.—The term ‘‘eligible area’’ means a met- ropolitan area meeting the requirements of section
p.001467: 2601 that are applicable to the area.
p.001467: (2) METROPOLITAN AREA.—The term ‘‘metropolitan area’’ means an area that is referred to in the HIV/AIDS
p.001467: Surveil- lance Report of the Centers for Disease Control and Prevention as a metropolitan area, and that has a
p.001467: population of 50,000 or more individuals.
p.001467:
p.001467: January 30, 2020 As Amended Through P.L. 116-94,
p.001467: Enacted December 20, 2019
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p.001467: Sec. 2609 PUBLIC HEALTH SERVICE ACT
p.001467:
p.001467: Subpart II—Transitional Grants
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p.001468: January 30, 2020
p.001468: SEC. 2609. ø300ff–19¿ ESTABLISHMENT OF PROGRAM.
p.001468: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001468: Administration, shall make grants for the purpose of providing services described in sec- tion 2604 in transitional
p.001468: areas, subject to the same provisions re- garding the allocation of grant funds as apply under subsection (c) of
p.001468: such section.
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p.001468: calendar year for which such data is available, such area shall be treated as having met the criteria of such
p.001468: subparagraph if not more than 5 percent of the total from grants awarded to such area under this part is
p.001468: unobligated as of the end of the most re- cent fiscal year for which such data is available.
p.001468: (C) EXCEPTION REGARDING STATUS AS ELIGIBLE AREA.— Subparagraphs (A) and (B) do not apply for a fiscal
p.001468: year if the metropolitan area involved qualifies under subpart I as an eligible area.
p.001468: (d) APPLICATION OF CERTAIN PROVISIONS OF SUBPART I.—
p.001468: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001469: PUBLIC HEALTH SERVICE ACT
p.001469: Sec. 2609
p.001469:
p.001469: (1) ADMINISTRATION; PLANNING COUNCIL.—
p.001469: (A) IN GENERAL.—The provisions of section 2602 apply with respect to a grant under subsection (a) for a
p.001469: transi- tional area to the same extent and in the same manner as such provisions apply with respect to a grant
p.001469: under sub- part I for an eligible area, except that, subject to subpara- graph (B), the chief elected official of the
p.001469: transitional area may elect not to comply with the provisions of section 2602(b) if the official provides
p.001469: documentation to the Sec- retary that details the process used to obtain community input (particularly
p.001469: from those with HIV) in the transi- tional area for formulating the overall plan for priority set- ting and
p.001469: allocating funds from the grant under subsection (a).
p.001469: (B) EXCEPTION.—For each of the fiscal years 2007
p.001469: through 2013, the exception described in subparagraph (A) does not apply if the transitional area involved
p.001469: received funding under subpart I for fiscal year 2006.
p.001469: (2) TYPE AND DISTRIBUTION OF GRANTS; TIMEFRAME FOR OB- LIGATION AND EXPENDITURE OF GRANT FUNDS.—
p.001469: (A) FORMULA GRANTS; SUPPLEMENTAL GRANTS.—The provisions of section 2603 apply with respect to grants
p.001469: under subsection (a) to the same extent and in the same manner as such provisions apply with respect
p.001469: to grants under subpart I, subject to subparagraphs (B) and (C).
p.001469: (B) FORMULA GRANTS; INCREASE IN GRANT.—For pur- poses of subparagraph (A), section 2603(a)(4) does
p.001469: not apply.
p.001469: (C) SUPPLEMENTAL GRANTS; SINGLE PROGRAM WITH SUBPART I PROGRAM.—With respect to section 2603(b)
p.001469: as applied for purposes of subparagraph (A):
p.001469: (i) The Secretary shall combine amounts available pursuant to such subparagraph with amounts avail- able for
p.001469: carrying out section 2603(b) and shall admin- ister the two programs as a single program.
p.001469: (ii) In the single program, the Secretary has dis- cretion in allocating amounts between eligible areas
p.001469: under subpart I and transitional areas under this sec- tion, subject to the eligibility criteria that apply under such
p.001469: section, and subject to section 2603(b)(2)(C) (re- lating to priority in making grants).
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p.001471: (2) The reductions shall be made before the amounts re- ferred to in paragraph (1) are used for
p.001471: purposes of section 2603(a)(4).
p.001471: (3) If the amounts referred to in paragraph (1) are not suf- ficient for making all the reductions, the reductions
p.001471: shall be re- duced until the total amount of the reductions equals the total of the amounts referred to in such
p.001471: paragraph.
p.001471: (e) RULES OF CONSTRUCTION REGARDING FIRST SUBSEQUENT FISCAL YEAR.—Paragraphs (1) and (2) of subsection
p.001471: (c) apply with respect to each series of fiscal years during which a metropolitan area is an eligible
p.001471: area under subpart I or a transitional area under section 2609 for a fiscal year and then for a subsequent fis-
p.001471: cal year ceases to be such an area by reason of section 2601(b) or 2609(c)(2), respectively, rather
p.001471: than applying to a single such se- ries. Paragraph (3) of subsection (c) applies with respect to each se- ries
p.001471: of fiscal years during which a metropolitan area is a transi- tional area under section 2609 for a fiscal
p.001471: year and then for a sub- sequent fiscal year becomes an eligible area under subpart I, rather than applying to a single
p.001471: such series.
p.001471: PART B—CARE GRANT PROGRAM 6
p.001471: Subpart I—General Grant Provisions
p.001471: SEC. 2611. ø300ff–21¿ GRANTS.
p.001471: The Secretary shall, subject to the availability of appropria- tions, make grants to States to enable
p.001471: such States to improve the quality, availability and organization of health care and support services for
p.001471: individuals and families with HIV/AIDS. The authority
p.001471:
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p.001471: January 30, 2020
p.001471: 6 See footnote at the beginning of part A.
p.001471: Section 8(a) of Public Law 104–146 (110 Stat. 1372) establishes a condition for the receipt of grants under part B.
p.001471: The condition relates to notification of spouses of HIV-infected patients.
p.001471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: PUBLIC HEALTH SERVICE ACT
p.001473: Sec. 2612
p.001473:
p.001473: of the Secretary to provide grants under part B is subject to section 2626(e)(2) (relating to the decrease in
p.001473: perinatal transmission of HIV/AIDS).
p.001473: SEC. 2612. ø300ff–22¿ GENERAL USE OF GRANTS.
p.001473: (a) IN GENERAL.—A State may use amounts provided under grants made under section 2611 for—
p.001473: (1) core medical services described in subsection (b);
p.001473: (2) support services described in subsection (c); and
p.001473: (3) administrative expenses described in section 2618(b)(3).
p.001473: (b) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001473: (1) IN GENERAL.—With respect to a grant under section 2611 for a State for a grant year, the State shall, of
p.001473: the portion of the grant remaining after reserving amounts for purposes of subparagraphs (A) and (E)(ii)(I) of
p.001473: section 2618(b)(3), use not less than 75 percent to provide core medical services that are needed in the
p.001473: State for individuals with HIV/AIDS who are identified and eligible under this title (including services
p.001473: re- garding the co-occurring conditions of the individuals).
p.001473: (2) WAIVER.—
p.001473: (A) IN GENERAL.—The Secretary shall waive the appli- cation of paragraph (1) with respect to a State for a grant year
p.001473: if the Secretary determines that, within the State—
p.001473: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001473: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
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p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: January 30, 2020
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p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
p.001473: State shall for each of such populations in the eligible area use, from the grants made for the area
p.001473: under section 2601(a) for a fiscal year, not less than the percentage constituted by the ratio of the
p.001473: population in- volved (infants, children, youth, or women in such area) with HIV/AIDS to the general
p.001473: population in such area of individuals with HIV/AIDS.
p.001473: (2) WAIVER.—With respect to the population involved, the Secretary may provide to a State a waiver of
p.001473: the requirement of paragraph (1) if such State demonstrates to the satisfaction
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001475: PUBLIC HEALTH SERVICE ACT
p.001475: Sec. 2613
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p.001475: January 30, 2020
p.001475: of the Secretary that the population is receiving HIV-related health services through the State medicaid
p.001475: program under title XIX of the Social Security Act, the State children’s health in- surance program under
p.001475: title XXI of such Act, or other Federal or State programs.
p.001475: (f) CONSTRUCTION.—A State may not use amounts received under a grant awarded under section 2611 to purchase or
p.001475: improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or
p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001475: access and services and those who reside in historically underserved communities;
p.001475: (B) the service plan established under subsection (c)(2) by such consortium is consistent with the comprehensive
p.001475: plan under section 2617(b)(4) and addresses the special care and service needs of the populations and
p.001475: subpopula- tions identified under subparagraph (A); and
p.001475: (C) except as provided in paragraph (2), the consor- tium will be a single coordinating entity that will
p.001475: integrate the delivery of services among the populations and sub- populations identified under subparagraph
p.001475: (A).
p.001475: (2) EXCEPTION.—Subparagraph (C) of paragraph (1) shall not apply to any applicant consortium that the
p.001475: State deter- mines will operate in a community or locality in which it has been demonstrated by the
p.001475: applicant consortium that—
p.001475: (A) subpopulations exist within the community to be served that have unique service requirements; and
p.001475: (B) such unique service requirements cannot be ade- quately and efficiently addressed by a single
p.001475: consortium serving the entire community or locality.
p.001475: (c) APPLICATION.—
p.001475: (1) IN GENERAL.—To receive assistance from the State under subsection (a), a consortium shall prepare and submit
p.001475: to the State, an application that—
p.001475: (A) demonstrates that the consortium includes agen- cies and community-based organizations—
p.001475: (i) with a record of service to populations and sub- populations with HIV/AIDS requiring care within the
p.001475: community to be served; and
p.001475: (ii) that are representative of populations and sub- populations reflecting the local incidence of HIV and that
p.001475: are located in areas in which such populations re- side;
p.001475: (B) demonstrates that the consortium has carried out an assessment of service needs within the geographic area
p.001475: to be served and, after consultation with the entities de- scribed in paragraph (2), has established a plan to
p.001475: ensure the delivery of services to meet such identified needs that shall include—
p.001475: (i) assurances that service needs will be addressed through the coordination and expansion of existing programs
p.001475: before new programs are created;
p.001475: (ii) assurances that, in metropolitan areas, the ge- ographic area to be served by the consortium cor- responds
p.001475: to the geographic boundaries of local health and support services delivery systems to the extent
p.001475: practicable;
p.001475: (iii) assurances that, in the case of services for in- dividuals residing in rural areas, the applicant consor- tium
p.001475: shall deliver case management services that link available community support services to appropriate specialized
p.001475: medical services; and
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: 1477
p.001477: PUBLIC HEALTH SERVICE ACT
p.001477: Sec. 2613
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p.001477: (iv) assurances that the assessment of service needs and the planning of the delivery of services will
p.001477: include participation by individuals with HIV/AIDS;
p.001477: (C) demonstrates that adequate planning has occurred to meet the special needs of families with HIV/AIDS, in-
p.001477: cluding family centered and youth centered care;
p.001477: (D) demonstrates that the consortium has created a mechanism to evaluate periodically—
p.001477: (i) the success of the consortium in responding to identified needs; and
p.001477: (ii) the cost-effectiveness of the mechanisms em- ployed by the consortium to deliver comprehensive care;
p.001477: (E) demonstrates that the consortium will report to the State the results of the evaluations described
p.001477: in sub- paragraph (D) and shall make available to the State or the Secretary, on request, such data and
p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001477: January 30, 2020
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p.001477: (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for
p.001477: adult and pediatric HIV-related care demonstration projects; and then
p.001477: (2) to any other existing HIV care consortia.
p.001477: (f) ALLOCATION OF FUNDS; TREATMENT AS SUPPORT SERVICES.— For purposes of the requirement of section 2612(b)(1),
p.001477: expenditures of grants under section 2611 for or through consortia under this section are deemed to be
p.001477: support services, not core medical serv- ices. The preceding sentence may not be construed as having any
p.001477: legal effect on the provisions of subsection (a) that relate to author- ized expenditures of the grant.
p.001477: SEC. 2614. ø300ff–24¿ GRANTS FOR HOME- AND COMMUNITY-BASED CARE.
p.001477: (a) USES.—A State may use amounts provided under a grant awarded under section 2611 to make grants
p.001477: under section 2612(b)(3)(J) to entities to—
p.001477: (1) provide home- and community-based health services for individuals with HIV/AIDS pursuant to written plans of
p.001477: care prepared by a case management team, that shall include ap- propriate health care professionals, in such
p.001477: State for providing such services to such individuals;
p.001477: (2) provide outreach services to individuals with HIV/ AIDS, including those individuals in rural areas;
p.001477: and
p.001477: (3) provide for the coordination of the provision of services under this section with the provision of
p.001477: HIV-related health services, including specialty care and vaccinations for hepatitis co-infection, provided by public
p.001477: and private entities.
p.001477: (b) PRIORITY.—In awarding grants under subsection (a), a State shall give priority to entities that
p.001477: provide assurances to the State that—
p.001477: (1) such entities will participate in HIV care consortia if such consortia exist within the State; and
p.001477: (2) such entities will utilize amounts provided under such grants for the provision of home- and
p.001477: community-based serv- ices to low-income individuals with HIV/AIDS.
p.001477: (c) DEFINITION.—As used in section 2611, the term ‘‘home- and community-based health services’’—
p.001477: (1) means, with respect to an individual with HIV/AIDS, skilled health services furnished to the
p.001477: individual in the indi- vidual’s home pursuant to a written plan of care established by a case management team, that
p.001477: shall include appropriate health care professionals, for the provision of such services and items described in
p.001477: paragraph (2);
p.001477: (2) includes—
p.001477: (A) durable medical equipment;
p.001477: (B) home health aide services and personal care serv- ices furnished in the home of the individual;
p.001477: (C) day treatment or other partial hospitalization serv- ices;
p.001477: (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such
p.001477: therapy);
p.001477: (E) routine diagnostic testing administered in the home of the individual; and
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001479: 1479
p.001479: PUBLIC HEALTH SERVICE ACT
p.001479: Sec. 2616
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p.001479: (F) appropriate mental health, developmental, and re- habilitation services; and
p.001479: (3) does not include—
p.001479: (A) inpatient hospital services; and
p.001479: (B) nursing home and other long term care facilities.
p.001479: SEC. 2615. ø300ff–25¿ CONTINUUM OF HEALTH INSURANCE COVERAGE.
p.001479: (a) IN GENERAL.—A State may use amounts received under a grant awarded under section 2611 to establish a
p.001479: program of finan- cial assistance under section 2612(b)(3)(F) to assist eligible low-in- come individuals with
p.001479: HIV/AIDS in—
p.001479: (1) maintaining a continuity of health insurance; or
p.001479: (2) receiving medical benefits under a health insurance program, including risk-pools.
p.001479: (b) LIMITATIONS.—Assistance shall not be utilized under sub- section (a)—
p.001479: (1) to pay any costs associated with the creation, capital- ization, or administration of a liability
p.001479: risk pool (other than those costs paid on behalf of individuals as part of premium contributions to
p.001479: existing liability risk pools); and
p.001479: (2) to pay any amount expended by a State under title XIX of the Social Security Act.
p.001479: SEC. 2616. ø300ff–26¿ PROVISION OF TREATMENTS.
p.001479: (a) IN GENERAL.—A State shall use a portion of the amounts provided under a grant awarded under section 2611
p.001479: to establish a program under section 2612(b)(3)(B) to provide therapeutics to treat HIV/AIDS or prevent the
p.001479: serious deterioration of health aris- ing from HIV/AIDS in eligible individuals, including measures for the
p.001479: prevention and treatment of opportunistic infections.
p.001479: (b) ELIGIBLE INDIVIDUAL.—To be eligible to receive assistance from a State under this section an individual
p.001479: shall—
p.001479: (1) have a medical diagnosis of HIV/AIDS; and
p.001479: (2) be a low-income individual, as defined by the State.
p.001479: (c) STATE DUTIES.—In carrying out this section the State shall—
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p.001479: January 30, 2020
p.001479: (1) ensure that the therapeutics included on the list of classes of core antiretroviral therapeutics
p.001479: established by the Secretary under subsection (e) are, at a minimum, the treat- ments provided by the State
p.001479: pursuant to this section;
p.001479: (2) provide assistance for the purchase of treatments deter- mined to be eligible under paragraph (1), and the
p.001479: provision of such ancillary devices that are essential to administer such treatments;
p.001479: (3) provide outreach to individuals with HIV/AIDS, and as appropriate to the families of such individuals;
p.001479: (4) facilitate access to treatments for such individuals;
p.001479: (5) document the progress made in making therapeutics described in subsection (a) available to individuals
p.001479: eligible for assistance under this section; and
p.001479: (6) encourage, support, and enhance adherence to and com- pliance with treatment regimens, including related
p.001479: medical monitoring.
p.001479: Of the amount reserved by a State for a fiscal year for use under this section, the State may not
p.001479: use more than 5 percent to carry
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001479: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1480
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p.001479: January 30, 2020
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p.001479: out services under paragraph (6), except that the percentage appli- cable with respect to such paragraph is 10
p.001479: percent if the State demonstrates to the Secretary that such additional services are es- sential and in no way
p.001479: diminish access to the therapeutics described in subsection (a).
p.001479: (d) DUTIES OF THE SECRETARY.—In carrying out this section, the Secretary shall review the current
p.001479: status of State drug reim- bursement programs established under section 2612(2) and assess barriers to the
p.001479: expanded availability of the treatments described in subsection (a). The Secretary shall also examine the
p.001479: extent to which States coordinate with other grantees under this title to re- duce barriers to the expanded
p.001479: availability of the treatments de- scribed in subsection (a).
p.001479: (e) LIST OF CLASSES OF CORE ANTIRETROVIRAL THERA- PEUTICS.—For purposes of subsection (c)(1),
p.001479: the Secretary shall de- velop and maintain a list of classes of core antiretroviral thera- peutics, which
p.001479: list shall be based on the therapeutics included in the guidelines of the Secretary known as the
p.001479: Clinical Practice Guidelines for Use of HIV/AIDS Drugs, relating to drugs needed to manage symptoms associated with
p.001479: HIV. The preceding sentence does not affect the authority of the Secretary to modify such Guide- lines.
p.001479: (f) USE OF HEALTH INSURANCE AND PLANS.—
p.001479: (1) IN GENERAL.—In carrying out subsection (a), a State may expend a grant under section 2611 to
p.001479: provide the thera- peutics described in such subsection by paying on behalf of in- dividuals with HIV/AIDS the
p.001479: costs of purchasing or maintain- ing health insurance or plans whose coverage includes a full range of
p.001479: such therapeutics and appropriate primary care serv- ices.
p.001479: (2) LIMITATION.—The authority established in paragraph
p.001479: (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans
p.001479: to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing
p.001479: therapeutics described in subsection (a).
p.001479: (g) DRUG REBATE PROGRAM.—A State shall ensure that any drug rebates received on drugs purchased from funds
p.001479: provided pur- suant to this section are applied to activities supported under this subpart, with priority given to
p.001479: activities described under this sec- tion.
p.001479: SEC. 2617. ø300ff–27¿ STATE APPLICATION.
p.001479: (a) IN GENERAL.—The Secretary shall not make a grant to a State under section 2611 for a fiscal year unless
p.001479: the State prepares and submits, to the Secretary, an application at such time, in such form, and containing such
p.001479: agreements, assurances, and information as the Secretary determines to be necessary to carry out section
p.001479: 2611.
p.001479: (b) DESCRIPTION OF INTENDED USES AND AGREEMENTS.—The application submitted under subsection (a) shall
p.001479: contain—
p.001479: (1) a detailed description of the HIV-related services pro- vided in the State to individuals and
p.001479: families with HIV/AIDS during the year preceding the year for which the grant is re-
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001481: 1481
p.001481: PUBLIC HEALTH SERVICE ACT
p.001481: Sec. 2617
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p.001481: January 30, 2020
p.001481: quested, and the number of individuals and families receiving such services, that shall include—
p.001481: (A) a description of the types of programs operated or funded by the State for the provision of HIV-related
p.001481: serv- ices during the year preceding the year for which the grant is requested and the methods utilized by the
p.001481: State to fi- nance such programs;
p.001481: (B) an accounting of the amount of funds that the State has expended for such services and programs during the
p.001481: year preceding the year for which the grant is re- quested; and
p.001481: (C) information concerning—
p.001481: (i) the number of individuals to be served with as- sistance provided under the grant;
p.001481: (ii) demographic data on the population of the in- dividuals to be served;
p.001481: (iii) the average cost of providing each category of HIV-related health services and the extent to which such
p.001481: cost is paid by third-party payors; and
p.001481: (iv) the aggregate amounts expended for each such category of services;
p.001481: (2) a determination of the size and demographics of the population of individuals with HIV/AIDS in the State;
p.001481: (3) a determination of the needs of such population, with particular attention to—
p.001481: (A) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services; and
p.001481: (B) disparities in access and services among affected subpopulations and historically underserved
p.001481: communities;
p.001481: (4) the designation of a lead State agency that shall—
p.001481: (A) administer all assistance received under section 2611;
p.001481: (B) conduct the needs assessment and prepare the State plan under paragraph (3);
p.001481: (C) prepare all applications for assistance under sec- tion 2611;
p.001481: (D) receive notices with respect to programs under this title;
p.001481: (E) every 2 years, collect and submit to the Secretary all audits, consistent with Office of
p.001481: Management and Budget circular A133, from grantees within the State, in- cluding audits regarding funds
p.001481: expended in accordance with section 2611; and
p.001481: (F) carry out any other duties determined appropriate by the Secretary to facilitate the coordination of programs under
p.001481: this title.
p.001481: (5) a comprehensive plan that describes the organization and delivery of HIV health care and support
p.001481: services to be funded with assistance received under section 2611 that shall include a description of the
p.001481: purposes for which the State in- tends to use such assistance, and that—
p.001481: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001481: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1482
p.001481:
p.001481: (A) 7 establishes priorities for the allocation of funds within the State based on—
p.001481: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under para- graph (2))
p.001481: and the needs of such population (as deter- mined under paragraph (3));
p.001481: (ii) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001481: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001481: Act to cover health care costs of eligible individuals and families with HIV/AIDS;
p.001481: (iii) capacity development needs resulting from disparities in the availability of HIV-related services
p.001481: in historically underserved communities and rural communities; and
p.001481: (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of
p.001481: greatest need within the State;
p.001481: (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and
p.001481: for informing the individuals of and enabling the indi- viduals to utilize the services, giving particular
p.001481: attention to eliminating disparities in access and services among af- fected subpopulations and historically
p.001481: underserved commu- nities, and including discrete goals, a timetable, and an ap- propriate allocation of funds;
p.001481: (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention
p.001481: (including outreach and early intervention) and for the prevention and treatment of substance abuse
p.001481: (including programs that provide comprehensive treatment services for such abuse);
p.001481: (D) describes the services and activities to be provided and an explanation of the manner in which the
p.001481: elements of the program to be implemented by the State with such assistance will maximize the quality of
p.001481: health and support services available to individuals with HIV/AIDS through- out the State;
p.001481: (E) provides a description of the manner in which services funded with assistance provided under section
p.001481: 2611 will be coordinated with other available related serv- ices for individuals with HIV/AIDS;
p.001481: (F) provides a description of how the allocation and utilization of resources are consistent with the
p.001481: statewide coordinated statement of need (including traditionally un- derserved populations and subpopulations)
p.001481: developed in
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p.001481: January 30, 2020
p.001481: 7 The placement of subparagraphs (A) through (C) is according to the probable intent of the Congress.
p.001481: Section 205(a)(3) of Public Law 106–345 (114 Stat. 1332, 1333) amended paragraph
p.001481: (4) by redesignating subparagraphs (A) through (C) as subparagraphs (D) through (F), and then instructed that new
p.001481: subparagraphs (A) through (C) be inserted before ‘‘subparagraph (C)’’. The amendment probably should have
p.001481: instructed that the new subparagraphs be inserted before sub- paragraph (D), as redesignated.
p.001481: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001483: 1483
p.001483: PUBLIC HEALTH SERVICE ACT
p.001483: Sec. 2617
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p.001483: partnership with other grantees in the State that receive funding under this title; and
p.001483: (G) includes key outcomes to be measured by all enti- ties in the State receiving assistance under this title;
p.001483: and
p.001483: (6) an assurance that the public health agency admin- istering the grant for the State will periodically
p.001483: convene a meeting of individuals with HIV/AIDS, members of a Federally recognized Indian tribe as represented in the
p.001483: State, represent- atives of grantees under each part under this title, providers, and public agency
p.001483: representatives for the purpose of developing a statewide coordinated statement of need;
p.001483: (7) an assurance by the State that—
p.001483: (A) the public health agency that is administering the grant for the State engages in a public advisory
p.001483: planning process, including public hearings, that includes the par- ticipants under paragraph (6), and the types
p.001483: of entities de- scribed in section 2602(b)(2), in developing the comprehen- sive plan under paragraph (5) and
p.001483: commenting on the im- plementation of such plan;
p.001483: (B) the State will—
p.001483: (i) to the maximum extent practicable, ensure that HIV-related health care and support services delivered pursuant to
p.001483: a program established with assistance provided under section 2611 will be provided without regard to the
p.001483: ability of the individual to pay for such services and without regard to the current or past health
p.001483: condition of the individual with HIV/AIDS;
p.001483: (ii) ensure that such services will be provided in a setting that is accessible to low-income
p.001483: individuals with HIV/AIDS;
p.001483: (iii) provide outreach to low-income individuals with HIV/AIDS to inform such individuals of the serv- ices
p.001483: available under section 2611; and
p.001483: (iv) in the case of a State that intends to use amounts provided under the grant for purposes de-
p.001483: scribed in 2615 8, submit a plan to the Secretary that demonstrates that the State has established a
p.001483: pro- gram that assures that—
p.001483: (I) such amounts will be targeted to individ- uals who would not otherwise be able to afford health
p.001483: insurance coverage; and
p.001483: (II) income, asset, and medical expense cri- teria will be established and applied by the State to
p.001483: identify those individuals who qualify for assist- ance under such program, and information con- cerning such
p.001483: criteria shall be made available to the public;
p.001483: (C) the State will provide for periodic independent peer review to assess the quality and appropriateness
p.001483: of
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p.001483: January 30, 2020
p.001483: 8 The word ‘‘section’’ probably should appear before ‘‘2615’’. Section 12(c)(3) of Public Law 104– 146 (110 Stat. 1373)
p.001483: provides that subsection (b)(3)(B)(iv) is amended by inserting ‘‘section’’ be- fore ‘‘2615’’, but the amendment
p.001483: cannot be executed because the term ‘‘2615’’ does not appear in paragraph (3)(B)(iv). The term formerly did
p.001483: appear in such paragraph, but former paragraph
p.001483: (3) was redesignated as paragraph (4) by section 3(c)(4)(B) of such Public Law (110 Stat. 1355).
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001483: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1484
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p.001483: January 30, 2020
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p.001483: health and support services provided by entities that re- ceive funds from the State under section 2611;
p.001483: (D) the State will permit and cooperate with any Fed- eral investigations undertaken regarding programs con-
p.001483: ducted under section 2611;
p.001483: (E) the State will maintain HIV-related activities at a level that is equal to not less than the level of
p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
p.001483: (E) describing efforts to remove legal barriers, includ- ing State laws and regulations, to routine testing.
p.001483: (c) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001483: SERVICES.—
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001485: 1485
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p.001485: Sec. 2617
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p.001485: January 30, 2020
p.001485: (1) IN GENERAL.—The Secretary may not make a grant under section 2611 to a State unless the State provides
p.001485: assur- ances that in the provision of services with assistance provided under the grant—
p.001485: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the pro-
p.001485: vider will not impose charges on any such individual for the provision of services under the grant;
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p.001485: non-Fed- eral contributions toward such costs in an amount equal to—
p.001485: (A) for the first fiscal year of payments under the grant, not less than 162⁄3 percent of such costs ($1 for
p.001485: each
p.001485: $5 of Federal funds provided in the grant);
p.001485: (B) for any second fiscal year of such payments, not less than 20 percent of such costs ($1 for each
p.001485: $4 of Fed- eral funds provided in the grant);
p.001485: (C) for any third fiscal year of such payments, not less than 25 percent of such costs ($1 for each $3 of
p.001485: Federal funds provided in the grant);
p.001485: (D) for any fourth fiscal year of such payments, not less than 331⁄3 percent of such costs ($1 for each $2 of
p.001485: Fed- eral funds provided in the grant); and
p.001485: (E) for any subsequent fiscal year of such payments, not less than 331⁄3 percent of such costs ($1 for each $2
p.001485: of Federal funds provided in the grant).
p.001485: (2) DETERMINATION OF AMOUNT OF NON-FEDERAL CON- TRIBUTION.—
p.001485: (A) IN GENERAL.—Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly
p.001485: evalu- ated, including plant, equipment, or services. Amounts provided by the Federal Government, and any
p.001485: portion of any service subsidized by the Federal Government, may not be included in determining the
p.001485: amount of such non- Federal contributions.
p.001485: (B) INCLUSION OF CERTAIN AMOUNTS.—
p.001485: (i) In making a determination of the amount of non-Federal contributions made by a State for pur- poses
p.001485: of paragraph (1), the Secretary shall, subject to clause (ii), include any non-Federal contributions pro-
p.001485: vided by the State for HIV-related services, without
p.001485: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001487: 1487
p.001487: PUBLIC HEALTH SERVICE ACT
p.001487: Sec. 2618
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p.001487: January 30, 2020
p.001487: regard to whether the contributions are made for pro- grams established pursuant to this title;
p.001487: (ii) In making a determination for purposes of clause (i), the Secretary may not include any non-Fed- eral
p.001487: contributions provided by the State as a condition of receiving Federal funds under any program under this title
p.001487: (except for the program established in section 2611) or under other provisions of law.
p.001487: (3) APPLICABILITY OF REQUIREMENT.—
p.001487: (A) NUMBER OF CASES.—A State referred to in para- graph (1) is any State for which the number of
p.001487: cases of HIV/AIDS reported to and confirmed by the Director of the Centers for Disease Control and Prevention
p.001487: for the period described in subparagraph (B) constitutes in excess of 1 percent of the aggregate number of
p.001487: such cases reported to and confirmed by the Director for such period for the United States.
p.001487: (B) PERIOD OF TIME.—The period referred to in sub- paragraph (A) is the 2-year period preceding the fiscal year
p.001487: for which the State involved is applying to receive a grant under subsection (a).
p.001487: (C) PUERTO RICO.—For purposes of paragraph (1), the number of cases of HIV/AIDS reported and confirmed for the
p.001487: Commonwealth of Puerto Rico for any fiscal year shall be deemed to be less than 1 percent.
p.001487: (4) DIMINISHED STATE CONTRIBUTION.—With respect to a State that does not make available the entire
p.001487: amount of the non-Federal contribution referred to in paragraph (1), the State shall continue to be
p.001487: eligible to receive Federal funds under a grant under section 2611, except that the Secretary in providing
p.001487: Federal funds under the grant shall provide such funds (in accordance with the ratios prescribed in
p.001487: paragraph (1)) only with respect to the amount of funds contributed by such State.
p.001487: SEC. 2618. ø300ff–28¿ DISTRIBUTION OF FUNDS.
p.001487: (a) AMOUNT OF GRANT TO STATE.—
p.001487: (1) MINIMUM ALLOTMENT.—Subject to the extent of amounts made available under section 2623, the
p.001487: amount of a grant to be made under section 2611 for—
p.001487: (A) each of the 50 States, the District of Columbia, Guam, and the Virgin Islands (referred to in this
p.001487: para- graph as a ‘‘covered State’’) for a fiscal year shall be the greater of—
p.001487: (i)(I) with respect to a covered State that has less than 90 living cases of AIDS, as determined under
p.001487: paragraph (2)(D), $200,000; or
p.001487: (II) with respect to a covered State that has 90 or more living cases of AIDS, as determined under para- graph (2)(D),
p.001487: $500,000; and
p.001487: (ii) an amount determined under paragraph (2) and then, as applicable, increased under paragraph (2)(H);
p.001487: and
p.001487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001487: deter- mined under paragraph (2).
p.001487: (2) DETERMINATION.—
p.001487: (A) FORMULA.—For purposes of paragraph (1), the amount referred to in this paragraph for a State (including
p.001487: a territory) for a fiscal year is, subject to subparagraphs
p.001487: (E) and (F)—
p.001487: (i) an amount equal to the amount made available under section 2623 for the fiscal year involved for grants
p.001487: pursuant to paragraph (1), subject to subpara- graph (F); and
p.001487: (ii) the percentage constituted by the sum of—
p.001487: (I) the product of 0.75 and the ratio of the State distribution factor for the State or territory (as
p.001487: determined under subsection (B)) to the sum of the respective State distribution factors for all States or
p.001487: territories;
p.001487: (II) the product of .20 and the ratio of the non-EMA distribution factor for the State or terri- tory (as
p.001487: determined under subparagraph (C)) to the sum of the respective non-EMA distribution factors for all States
p.001487: or territories; and
p.001487: (III) if the State does not for such fiscal year contain any area that is an eligible area under
p.001487: subpart I of part A or any area that is a transi- tional area under section 2609 (referred to in this
p.001487: subclause as a ‘‘no-EMA State’’), the product of
p.001487: 0.05 and the ratio of the number of cases that ap- plies for the State under subparagraph (D) to the sum of the
p.001487: respective numbers of cases that so apply for all no-EMA States.
p.001487: (B) STATE DISTRIBUTION FACTOR.—For purposes of sub- paragraph (A)(ii)(I), the term ‘‘State distribution factor’’
p.001487: means an amount equal to the number of living cases of HIV/AIDS in the State involved, as determined under
p.001487: sub- paragraph (D).
p.001487: (C) NON-EMA DISTRIBUTION FACTOR.—For purposes of subparagraph (A)(ii)(II), the term ‘‘non-ema distribution
p.001487: factor’’ means an amount equal to the sum of—
p.001487: (i) the number of living cases of HIV/AIDS in the State involved, as determined under subparagraph
p.001487: (D); less
p.001487: (ii) a number equal to the sum of—
p.001487: (I) the total number of living cases of HIV/ AIDS that are within areas in such State that are eligible areas
p.001487: under subpart I of part A for the fis- cal year involved, which individual number for an area is the number that
p.001487: applies under section 2601 for the area for such fiscal year; and
p.001487: (II) the total number of such cases that are within areas in such State that are transitional areas
p.001487: under section 2609 for such fiscal year, which individual number for an area is the num-
p.001487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001489: 1489
p.001489: PUBLIC HEALTH SERVICE ACT
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p.001489: ber that applies under such section for the fiscal year.
p.001489: (D) LIVING CASES OF HIV/AIDS.—
p.001489: (i) REQUIREMENT OF NAMES-BASED REPORTING.— Except as provided in clause (ii), the number deter- mined
p.001489: under this subparagraph for a State for a fiscal year for purposes of subparagraph (B) is the number of living
p.001489: names-based cases of HIV/AIDS in the State that, as of December 31 of the most recent calendar year
p.001489: for which such data is available, have been re- ported to and confirmed by the Director of the Centers for
p.001489: Disease Control and Prevention.
p.001489: (ii) TRANSITION PERIOD; EXEMPTION REGARDING NON-AIDS CASES.—For each of the fiscal years 2007 through
p.001489: 2012, a State is, subject to clauses (iii) through (v), exempt from the requirement under
p.001489: clause (i) that living non-AIDS names-based cases of HIV be reported unless—
p.001489: (I) a system was in operation as of December 31, 2005, that provides sufficiently accurate and reliable
p.001489: names-based reporting of such cases throughout the State, subject to clause (vii); or
p.001489: (II) no later than the beginning of fiscal year 2008 or a subsequent fiscal year through fiscal year
p.001489: 2012, the Secretary, after consultation with the chief executive of the State, determines that a system has
p.001489: become operational in the State that provides sufficiently accurate and reliable names- based reporting
p.001489: of such cases throughout the State.
p.001489: (iii) REQUIREMENTS FOR EXEMPTION FOR FISCAL YEAR 2007.—For fiscal year 2007, an exemption under clause
p.001489: (ii) for a State applies only if, by October 1, 2006—
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p.001489: (I)(aa) the State had submitted to the Sec- retary a plan for making the transition to suffi- ciently
p.001489: accurate and reliable names-based report- ing of living non-AIDS cases of HIV; or
p.001489: (bb) all statutory changes necessary to provide for sufficiently accurate and reliable reporting of such cases
p.001489: had been made; and
p.001489: (II) the State had agreed that, by April 1, 2008, the State will begin accurate and reliable names-based
p.001489: reporting of such cases, except that such agreement is not required to provide that, as of such date, the
p.001489: system for such reporting be fully sufficient with respect to accuracy and reli- ability throughout the
p.001489: area.
p.001489: (iv) REQUIREMENT FOR EXEMPTION AS OF FISCAL YEAR 2008.—For each of the fiscal years 2008 through
p.001489: 2012, an exemption under clause (ii) for a State ap- plies only if, as of April 1, 2008, the State is substan-
p.001489: tially in compliance with the agreement under clause (iii)(II).
p.001489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001489: Sec. 2618 PUBLIC HEALTH SERVICE ACT 1490
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p.001489: (v) PROGRESS TOWARD NAMES-BASED REPORTING.— For fiscal year 2009 or a subsequent fiscal year, the Secretary
p.001489: may terminate an exemption under clause
p.001489: (ii) for a State if the State submitted a plan under clause (iii)(I)(aa) and the Secretary determines
p.001489: that the State is not substantially following the plan.
p.001489: (vi) COUNTING OF CASES IN AREAS WITH EXEMP- TIONS.—
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p.001489: January 30, 2020
p.001489: (I) IN GENERAL.—With respect to a State that is under a reporting system for living non-AIDS cases of HIV
p.001489: that is not names-based (referred to in this subparagraph as ‘‘code-based reporting’’), the Secretary
p.001489: shall, for purposes of this subpara- graph, modify the number of such cases reported for the State in order
p.001489: to adjust for duplicative re- porting in and among systems that use code-based reporting.
p.001489: (II) ADJUSTMENT RATE.—The adjustment rate under subclause (I) for a State shall be a reduc- tion of 5
p.001489: percent for fiscal years before fiscal year 2012 (and 6 percent for fiscal year 2012) in the number of
p.001489: living non-AIDS cases of HIV reported for the State.
p.001489: (III) INCREASED ADJUSTMENT FOR CERTAIN STATES PREVIOUSLY USING CODE-BASED REPORT- ING.—For
p.001489: purposes of this subparagraph for each of fiscal years 2010 through 2012, the Secretary shall deem the
p.001489: applicable number of living cases of HIV/AIDS in a State that were reported to and confirmed by the Centers for
p.001489: Disease Control and Prevention to be 3 percent higher than the actual number if—
p.001489: (aa) there is an area in such State that satisfies all of the conditions described in items
p.001489: (aa) through (cc) of section 2603(a)(3)(C)(vi)(III); or
p.001489: (bb)(AA) fiscal year 2007 was the first year in which the count of living non-AIDS cases of HIV in such
p.001489: area, for purposes of this part, was based on a names-based reporting system; and
p.001489: (BB) the amount of funding that such State received under this part for fiscal year 2007 was less than
p.001489: 70 percent of the amount of funding that such State received under such part for fiscal year 2006.
p.001489: (vii) LIST OF STATES MEETING STANDARD REGARD- ING DECEMBER 31, 2005.—
p.001489: (I) IN GENERAL.—If a State is specified in sub- clause (II), the State shall be considered to meet the
p.001489: standard described in clause (ii)(I). No other State may be considered to meet such standard.
p.001489: (II) RELEVANT STATES.—For purposes of sub- clause (I), the States specified in this subclause
p.001489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001491: 1491
p.001491: PUBLIC HEALTH SERVICE ACT
p.001491: Sec. 2618
p.001491:
p.001491:
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p.001491:
p.001491: January 30, 2020
p.001491: are the following: Alaska, Alabama, Arkansas, Ar- izona, Colorado, Florida, Indiana, Iowa, Idaho, Kansas,
p.001491: Louisiana, Michigan, Minnesota, Mis- souri, Mississippi, North Carolina, North Dakota, Nebraska, New
p.001491: Jersey, New Mexico, New York, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah,
p.001491: Virginia, Wis- consin, West Virginia, Wyoming, Guam, and the Virgin Islands.
p.001491: (viii) RULES OF CONSTRUCTION REGARDING ACCEPT- ANCE OF REPORTS.—
p.001491: (I) CASES OF AIDS.—With respect to a State that is subject to the requirement under clause (i) and is not in
p.001491: compliance with the requirement for names-based reporting of living non-AIDS cases of HIV, the Secretary shall,
p.001491: notwithstanding such noncompliance, accept reports of living cases of AIDS that are in accordance with such
p.001491: clause.
p.001491: (II) APPLICABILITY OF EXEMPTION REQUIRE- MENTS.—The provisions of clauses (ii) through (vii) may not be
p.001491: construed as having any legal effect for fiscal year 2013 or any subsequent fiscal year, and accordingly, the
p.001491: status of a State for purposes of such clauses may not be considered after fiscal year 2012.
p.001491: (ix) PROGRAM FOR DETECTING INACCURATE OR FRAUDULENT COUNTING.—The Secretary shall carry out a
p.001491: program to monitor the reporting of names- based cases for purposes of this subparagraph and to detect
p.001491: instances of inaccurate reporting, including fraudulent reporting.
p.001491: (x) FUTURE FISCAL YEARS.—For fiscal years begin- ning with fiscal year 2013, determinations under this paragraph
p.001491: shall be based only on living names-based cases of HIV/AIDS with respect to the State involved.
p.001491: (E) CODE-BASED STATES; LIMITATION ON INCREASE IN GRANT.—
p.001491: (i) IN GENERAL.—For each of the fiscal years 2007 through 2012, if code-based reporting (within the meaning
p.001491: of subparagraph (D)(vi)) applies in a State as of the beginning of the fiscal year involved, then not-
p.001491: withstanding any other provision of this paragraph, the amount of the grant pursuant to paragraph (1) for the
p.001491: State may not for the fiscal year involved exceed by more than 5 percent the amount of the grant pur-
p.001491: suant to this paragraph for the State for the preceding fiscal year, except that the limitation under this clause may
p.001491: not result in a grant pursuant to paragraph (1) for a fiscal year that is less than the minimum amount that
p.001491: applies to the State under such paragraph for such fiscal year.
p.001491: (ii) USE OF AMOUNTS INVOLVED.—For each of the fiscal years 2007 through 2012, amounts available as a
p.001491: result of the limitation under clause (i) shall be
p.001491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001491:
p.001491:
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p.001491: Sec. 2618 PUBLIC HEALTH SERVICE ACT 1492
p.001491: made available by the Secretary as additional amounts for grants pursuant to section 2620,
p.001491: subject to subparagraph (H).
p.001491: (F) 9 APPROPRIATIONS FOR TREATMENT DRUG PRO- GRAM.—
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p.001491: State shall be the product of—
p.001491: (I) 10 100 percent of such amount, less the percent- age reserved under clause (ii)(V); and
p.001491: (II) 10 the percentage constituted by the ratio of the State distribution factor for the State (as
p.001491: deter- mined under subparagraph (B)) to the sum of the State distribution factors for all States;
p.001491: which product shall then, as applicable, be increased under subparagraph (H).
p.001491: (ii) SUPPLEMENTAL TREATMENT DRUG GRANTS.—
p.001491: (I) IN GENERAL.—From amounts made avail- able under subclause (V), the Secretary shall award
p.001491: supplemental grants to States described in subclause (II) to enable such States to purchase and distribute to
p.001491: eligible individuals under section 2616(b) pharmaceutical therapeutics described under subsections (c)(2) and
p.001491: (e) of such section.
p.001491: (II) ELIGIBLE STATES.—For purposes of sub- clause (I), a State shall be an eligible State if the State did not
p.001491: have unobligated funds subject to re- allocation under section 2618(d) in the previous fiscal year and, in
p.001491: accordance with criteria estab- lished by the Secretary, demonstrates a severe need for a grant under
p.001491: this clause. For purposes of determining severe need, the Secretary shall consider eligibility standards,
p.001491: formulary composi- tion, the number of eligible individuals to whom a State is unable to provide therapeutics
p.001491: described in section 2616(a), and an unanticipated increase of eligible individuals with HIV/AIDS.
p.001491: (III) STATE REQUIREMENTS.—The Secretary may not make a grant to a State under this clause unless the State
p.001491: agrees that the State will make available (directly or through donations of public or private entities)
p.001491: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to $1
p.001491: for each $4 of Fed- eral funds provided in the grant, except that the Secretary may waive this subclause
p.001491: if the State has otherwise fully complied with section 2617(d)
p.001491:
p.001491:
p.001491:
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p.001491:
p.001491: January 30, 2020
p.001491: 9 The amendments made by section 203(c) of Public Law 109–415 to section 2618(a)(2)(G) have been carried out to
p.001491: subparagraph (F), as redesignated by subsection (b)(4) of such Public Law, in order to reflect the probable
p.001491: intent of Congress.
p.001491: 10 Indentation of subclauses (I) and (II) are so in law. See section 206(e)(1) of Public Law 106– 345 (114 Stat. 1336).
p.001491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001493: 1493
p.001493: PUBLIC HEALTH SERVICE ACT
p.001493: Sec. 2618
p.001493:
p.001493: with respect to the grant year involved. The provi- sions of this subclause shall apply to States that are
p.001493: not required to comply with such section 2617(d).
p.001493: (IV) USE AND COORDINATION.—Amounts made available under a grant under this clause shall only be used by the
p.001493: State to provide HIV/AIDS-re- lated medications. The State shall coordinate the use of such amounts with the
p.001493: amounts otherwise provided under section 2616(a) in order to maxi- mize drug coverage.
p.001493: (V) FUNDING.—For the purpose of making grants under this clause, the Secretary shall each fiscal year
p.001493: reserve 5 percent of the amount re- ferred to in clause (i) with respect to section 2616.
p.001493: (iii) CODE-BASED STATES; LIMITATION ON INCREASE IN FORMULA GRANT.—The limitation under subpara- graph
p.001493: (E)(i) applies to grants pursuant to clause (i) of this subparagraph to the same extent and in the same manner as
p.001493: such limitation applies to grants pursuant to paragraph (1), except that the reference to min- imum
p.001493: grants does not apply for purposes of this clause. Amounts available as a result of the limitation under
p.001493: the preceding sentence shall be made available by the Secretary as additional amounts for grants under
p.001493: clause (ii) of this subparagraph.
p.001493: (H) 11 INCREASE IN FORMULA GRANTS.—
p.001493: (i) ASSURANCE OF AMOUNT.—
p.001493: (I) GENERAL RULE.—For fiscal year 2010, the Secretary shall ensure, subject to clauses (ii) through
p.001493: (iv), that the total for a State of the grant pursuant to paragraph (1) and the grant pursuant to subparagraph (F) is
p.001493: not less than 95 percent of such total for the State for fiscal year 2009.
p.001493: (II) RULE OF CONSTRUCTION.—With respect to the application of subclause (I), the 95 percent re- quirement under
p.001493: such subclause shall apply with respect to each grant awarded under paragraph
p.001493: (1) and with respect to each grant awarded under subparagraph (F).
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p.001493: State under a grant under section 2611, the State shall ensure that, of the aggregate amount so allocated, the total of
p.001493: the expenditures by such entities for administrative ex- penses does not exceed 10 percent (without
p.001493: regard to whether particular entities expend more than 10 percent for such expenses).
p.001493: (C) ADMINISTRATIVE ACTIVITIES.—For the purposes of subparagraph (A), amounts may be used for administrative
p.001493: activities that include routine grant administration and monitoring activities, including a clinical quality
p.001493: manage- ment program under subparagraph (E).
p.001493: (D) SUBCONTRACTOR ADMINISTRATIVE COSTS.—For the purposes of this paragraph, subcontractor administrative
p.001493: activities include—
p.001493: (i) usual and recognized overhead, including estab- lished indirect rates for agencies;
p.001493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001495: 1495
p.001495: PUBLIC HEALTH SERVICE ACT
p.001495: Sec. 2618
p.001495:
p.001495: (ii) management oversight of specific programs funded under this title; and
p.001495: (iii) other types of program support such as qual- ity assurance, quality control, and related activities.
p.001495: (E) CLINICAL QUALITY MANAGEMENT.—
p.001495: (i) REQUIREMENT.—Each State that receives a grant under section 2611 shall provide for the estab-
p.001495: lishment of a clinical quality management program to assess the extent to which HIV health services pro- vided
p.001495: to patients under the grant are consistent with the most recent Public Health Service guidelines for the
p.001495: treatment of HIV/AIDS and related opportunistic infection, and as applicable, to develop strategies for
p.001495: ensuring that such services are consistent with the guidelines for improvement in the access to and qual- ity of
p.001495: HIV health services.
p.001495: (ii) USE OF FUNDS.—
p.001495: (I) IN GENERAL.—From amounts received under a grant awarded under section 2611 for a fiscal year,
p.001495: a State may use for activities associ- ated with the clinical quality management pro- gram required in
p.001495: clause (i) not to exceed the lesser of—
p.001495: (aa) 5 percent of amounts received under the grant; or
p.001495: (bb) $3,000,000.
p.001495: (II) RELATION TO LIMITATION ON ADMINISTRA- TIVE EXPENSES.—The costs of a clinical quality management
p.001495: program under clause (i) may not be considered administrative expenses for purposes of the limitation
p.001495: established in subparagraph (A).
p.001495: (4) LIMITATION ON USE OF FUNDS.—Except as provided in paragraph (5), a State may not use more than a total of
p.001495: 15 per- cent of amounts received under a grant awarded under section 2611 for the purposes described in paragraphs (2)
p.001495: and (3).
p.001495: (5) EXCEPTION.—With respect to a State that receives the minimum allotment under subsection (a)(1) for a
p.001495: fiscal year, such State, from the amounts received under a grant awarded under section 2611 for such fiscal year
p.001495: for the activities de- scribed in paragraphs (2) and (3), may, notwithstanding para- graphs (2) through
p.001495: (4) 12, use not more than that amount re- quired to support one full-time-equivalent employee.
p.001495: (6) CONSTRUCTION.—A State may not use amounts re- ceived under a grant awarded under section 2611 to
p.001495: purchase or improve land, or to purchase, construct, or permanently im- prove (other than minor remodeling) any
p.001495: building or other fa- cility, or to make cash payments to intended recipients of serv- ices.
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p.001495: under section 2623(b)(2).
p.001495: SEC. 2619. ø300ff–29¿ TECHNICAL ASSISTANCE.
p.001495: The Secretary shall provide technical assistance in admin- istering and coordinating the activities
p.001495: authorized under section 2612, including technical assistance for the development and imple- mentation of statewide
p.001495: coordinated statements of need.
p.001495: SEC. 2620. ø300ff–29a¿ SUPPLEMENTAL GRANTS.
p.001495: (a) IN GENERAL.—For the purpose of providing services de- scribed in section 2612(a), the Secretary shall
p.001495: make grants to States—
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p.001495: January 30, 2020
p.001495: (1) whose applications under section 2617 have dem- onstrated the need in the State, on an objective and
p.001495: quantified basis, for supplemental financial assistance to provide such services; and
p.001495: (2) that did not, for the most recent grant year pursuant to section 2618(a)(1) or 2618(a)(2)(F)(i) for which
p.001495: data is avail- able, have more than 5 percent of grant funds under such sec- tions canceled, offset under section
p.001495: 2622(e), or covered by any waivers under section 2622(c).
p.001495: (b) DEMONSTRATED NEED.—The factors considered by the Sec- retary in determining whether an eligible area has a
p.001495: demonstrated need for purposes of subsection (a)(1) may include any or all of the following:
p.001495: (1) The unmet need for such services, as determined under section 2617(b).
p.001495: (2) An increasing need for HIV/AIDS-related services, in- cluding relative rates of increase in the
p.001495: number of cases of HIV/AIDS.
p.001495: (3) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging subpopulations.
p.001495: (4) The current prevalence of HIV/AIDS.
p.001495: (5) Relevant factors related to the cost and complexity of delivering health care to individuals with HIV/AIDS
p.001495: in the eli- gible area.
p.001495: (6) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.
p.001495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001497: 1497
p.001497: PUBLIC HEALTH SERVICE ACT
p.001497: Sec. 2621
p.001497:
p.001497: (7) The prevalence of homelessness.
p.001497: (8) The prevalence of individuals described under section 2602(b)(2)(M).
p.001497: (9) The relevant factors that limit access to health care, in- cluding geographic variation, adequacy of health
p.001497: insurance cov- erage, and language barriers.
p.001497: (10) The impact of a decline in the amount received pursu- ant to section 2618 on services available to all individuals
p.001497: with HIV/AIDS identified and eligible under this title.
p.001497: (c) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this section to a State to
p.001497: address the decline in serv- ices related to the decline in the amounts received pursuant to sec- tion 2618
p.001497: consistent with the grant award to the State for fiscal year 2006, to the extent that the factor under
p.001497: subsection (b)(10) (re- lating to a decline in funding) applies to the State.
p.001497: (d) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001497: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001497: shall include information detail- ing—
p.001497:
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p.001497: January 30, 2020
p.001497: (1) the total amount of supplemental funds available under
p.001497: this section for the year involved;
p.001497: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of section
p.001497: 2618(a)(2);
p.001497: (3) the amount of supplemental funds disbursed pursuant to subsection (c);
p.001497: (4) the disbursement of the remainder of the supplemental funds after taking into account the uses described in
p.001497: para- graphs (2) and (3); and
p.001497: (5) the rationale used for the amount of funds disbursed as described under paragraphs (2), (3), and (4).
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p.001497: Sec. 2621 PUBLIC HEALTH SERVICE ACT 1498
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p.001497: (3) agree that the grant will be used to provide funds di- rectly to emerging communities in the
p.001497: State, separately from other funds under this title that are provided by the State to such communities;
p.001497: and
p.001497: (4) submit the information described in subsection (c).
p.001497: (c) REPORTING REQUIREMENTS.—A State that desires a grant under this section shall, as part of the State
p.001497: application submitted under section 2617, submit a detailed description of the manner in which the State will use
p.001497: amounts received under the grant and of the severity of need. Such description shall include—
p.001497: (1) a report concerning the dissemination of supplemental funds under this section and the plan for the
p.001497: utilization of such funds in the emerging community;
p.001497: (2) a demonstration of the existing commitment of local re- sources, both financial and in-kind;
p.001497: (3) a demonstration that the State will maintain HIV-re- lated activities at a level that is equal to not less
p.001497: than the level of such activities in the State for the 1-year period preceding the fiscal year for which
p.001497: the State is applying to receive a grant under section 2611;
p.001497: (4) a demonstration of the ability of the State to utilize such supplemental financial resources in a manner
p.001497: that is im- mediately responsive and cost effective;
p.001497: (5) a demonstration that the resources will be allocated in accordance with the local demographic incidence of
p.001497: AIDS in- cluding appropriate allocations for services for infants, chil- dren, women, and families with
p.001497: HIV/AIDS;
p.001497: (6) a demonstration of the inclusiveness of the planning process, with particular emphasis on affected
p.001497: communities and individuals with HIV/AIDS; and
p.001497: (7) a demonstration of the manner in which the proposed services are consistent with local needs
p.001497: assessments and the statewide coordinated statement of need.
p.001497: (d) DEFINITIONS OF EMERGING COMMUNITY.—For purposes of this section, the term ‘‘emerging community’’ means a
p.001497: metropolitan area (as defined in section 2607) for which there has been reported to and confirmed by the Director of
p.001497: the Centers for Disease Control and Prevention a cumulative total of at least 500, but fewer than 1,000,
p.001497: cases of AIDS during the most recent period of 5 calendar years for which such data are available.
p.001497: (e) CONTINUED STATUS AS EMERGING COMMUNITY.—Notwith- standing any other provision of this section, a
p.001497: metropolitan area that is an emerging community for a fiscal year continues to be an emerging community until the
p.001497: metropolitan area fails, for three consecutive fiscal years—
p.001497: (1) to meet the requirements of subsection (d); and
p.001497: (2) to have a cumulative total of 750 or more living cases of AIDS (reported to and confirmed by the
p.001497: Director of the Cen- ters for Disease Control and Prevention) as of December 31 of the most recent calendar year for
p.001497: which such data is available.
p.001497: (f) DISTRIBUTION.—The amount of a grant under subsection (a) for a State for a fiscal year shall be an amount equal to
p.001497: the product of—
p.001497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001499: 1499
p.001499: PUBLIC HEALTH SERVICE ACT
p.001499: Sec. 2622
p.001499:
p.001499: (1) the amount available under section 2623(b)(1) for the fiscal year; and
p.001499: (2) a percentage equal to the ratio constituted by the num- ber of living cases of HIV/AIDS in emerging
p.001499: communities in the State to the sum of the respective numbers of such cases in such communities for all
p.001499: States.
p.001499: SEC. 2622. ø300ff–31a¿ TIMEFRAME FOR OBLIGATION AND EXPENDI- TURE OF GRANT FUNDS.
p.001499: (a) OBLIGATION BY END OF GRANT YEAR.—Effective for fiscal year 2007 and subsequent fiscal years,
p.001499: funds from a grant award made to a State for a fiscal year pursuant to section 2618(a)(1) or
p.001499: 2618(a)(2)(F), or under section 2620 or 2621, are available for obli- gation by the State through the end of
p.001499: the one-year period begin- ning on the date in such fiscal year on which funds from the award first become available
p.001499: to the State (referred to in this section as the ‘‘grant year for the award’’), except as provided in subsection
p.001499: (c)(1).
p.001499: (b) SUPPLEMENTAL GRANTS; CANCELLATION OF UNOBLIGATED BALANCE OF GRANT AWARD.—Effective for fiscal year 2007 and
p.001499: sub- sequent fiscal years, if a grant award made to a State for a fiscal year pursuant to section
p.001499: 2618(a)(2)(F)(ii), or under section 2620 or 2621, has an unobligated balance as of the end of the grant
p.001499: year for the award—
p.001499: (1) the Secretary shall cancel that unobligated balance of the award, and shall require the State to return any
p.001499: amounts from such balance that have been disbursed to the State; and
p.001499: (2) the funds involved shall be made available by the Sec- retary as additional amounts for grants pursuant to
p.001499: section 2620 for the first fiscal year beginning after the fiscal year in which the Secretary obtains
p.001499: the information necessary for de- termining that the balance is required under paragraph (1) to be
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p.001501: (1) EMERGING COMMUNITIES.—Of the amount appropriated under subsection (a) for a fiscal year, the Secretary
p.001501: shall re- serve $5,000,000 for grants under section 2621.
p.001501: (2) SUPPLEMENTAL GRANTS.—
p.001501: (A) IN GENERAL.—Of the amount appropriated under subsection (a) for a fiscal year in excess of the 2006
p.001501: ad- justed amount, the Secretary shall reserve 1⁄3 for grants under section 2620, except that the
p.001501: availability of the re- served funds for such grants is subject to section 2618(a)(2)(H) as applied
p.001501: for such year, and except that any amount appropriated exclusively for carrying out section 2616 (and,
p.001501: accordingly, distributed under section 2618(a)(2)(F)) is not subject to this subparagraph.
p.001501: (B) 2006 ADJUSTED AMOUNT.—For purposes of sub- paragraph (A), the term ‘‘2006 adjusted amount’’ means the
p.001501: amount appropriated for fiscal year 2006 under section 2677(b) (as such section was in effect for such fiscal year),
p.001501: excluding any amount appropriated for such year exclu- sively for carrying out section 2616 (and,
p.001501: accordingly, dis- tributed under section 2618(a)(2)(I), as so in effect).
p.001501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001501: Sec. 2625 PUBLIC HEALTH SERVICE ACT 1502
p.001501: Subpart II—Provisions Concerning Pregnancy and Perinatal Transmission of HIV
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p.001501: January 30, 2020
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p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
p.001501: (g) DEFINITIONS.—In this section:
p.001501: (1) The term ‘‘voluntary opt-out testing’’ means HIV/AIDS testing—
p.001501: (A) that is administered to an individual seeking other health care services; and
p.001501: (B) in which—
p.001501: (i) pre-test counseling is not required but the indi- vidual is informed that the individual will receive an
p.001501: HIV/AIDS test and the individual may opt out of such testing; and
p.001501: (ii) for those individuals with a positive test re- sult, post-test counseling (including referrals for
p.001501: care) is provided and confidentiality is protected.
p.001501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001503: 1503
p.001503: PUBLIC HEALTH SERVICE ACT
p.001503: Sec. 2628
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p.001503: (2) The term ‘‘universal testing of newborns’’ means HIV/ AIDS testing that is administered within 48
p.001503: hours of delivery to—
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p.001503: January 30, 2020
p.001503: (A) all infants born in the State; or
p.001503: (B) all infants born in the State whose mother’s HIV/ AIDS status is unknown at the time of delivery.
p.001503: (h) AUTHORIZATION OF APPROPRIATIONS.—Of the funds appro- priated annually to the Centers for Disease Control and
p.001503: Prevention for HIV/AIDS prevention activities, $30,000,000 shall be made available for each of the fiscal
p.001503: years 2007 through 2009 for grants under subsection (a), of which $20,000,000 shall be made available for grants to
p.001503: States with the policies described in subsection (b)(1), and $10,000,000 shall be made available for grants to
p.001503: States with the policies described in subsection (b)(2). Funds provided under this section are available until
p.001503: expended.
p.001503: SEC. 2626. ø300ff–34¿ PERINATAL TRANSMISSION OF HIV DISEASE; CON- TINGENT REQUIREMENT REGARDING STATE
p.001503: GRANTS UNDER THIS PART.
p.001503: (a) ANNUAL DETERMINATION OF REPORTED CASES.—A State shall annually determine the rate of reported
p.001503: cases of AIDS as a result of perinatal transmission among residents of the State.
p.001503: (b) CAUSES OF PERINATAL TRANSMISSION.—In determining the rate under subsection (a), a State shall also determine
p.001503: the possible causes of perinatal transmission. Such causes may include—
p.001503: (1) the inadequate provision within the State of prenatal counseling and testing in accordance with the
p.001503: guidelines issued by the Centers for Disease Control and Prevention;
p.001503: (2) the inadequate provision or utilization within the State of appropriate therapy or failure of such therapy
p.001503: to reduce perinatal transmission of HIV, including—
p.001503: (A) that therapy is not available, accessible or offered to mothers; or
p.001503: (B) that available therapy is offered but not accepted by mothers; or
p.001503: (3) other factors (which may include the lack of prenatal care) determined relevant by the State.
p.001503: (c) CDC REPORTING SYSTEM.—Not later than 4 months after the date of enactment of this subpart, the
p.001503: Director of the Centers for Disease Control and Prevention shall develop and implement a system to be used by
p.001503: States to comply with the requirements of subsections (a) and (b). The Director shall issue guidelines
p.001503: to en- sure that the data collected is statistically valid.
p.001503: SEC. 2627. ø300ff–37¿ STATE HIV TESTING PROGRAMS ESTABLISHED PRIOR TO OR AFTER ENACTMENT.
p.001503: Nothing in this subpart shall be construed to disqualify a State from receiving grants under this title if such State
p.001503: has established at any time prior to or after the date of enactment of this subpart a program of mandatory HIV testing.
p.001503: SEC. 2628. ø300ff–37a¿ RECOMMENDATIONS FOR REDUCING INCIDENCE OF PERINATAL TRANSMISSION.
p.001503: (a) STUDY BY INSTITUTE OF MEDICINE.—
p.001503: (1) IN GENERAL.—The Secretary shall request the Institute of Medicine to enter into an agreement with the
p.001503: Secretary
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001503: Sec. 2631 PUBLIC HEALTH SERVICE ACT 1504
p.001503: under which such Institute conducts a study to provide the fol- lowing:
p.001503: (A) For the most recent fiscal year for which the infor- mation is available, a determination of the number of new-
p.001503: born infants with HIV born in the United States with re- spect to whom the attending obstetrician for the
p.001503: birth did not know the HIV status of the mother.
p.001503: (B) A determination for each State of any barriers, in- cluding legal barriers, that prevent or discourage an obste-
p.001503: trician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn
p.001503: infants for HIV/AIDS in circumstances in which the obste- trician does not know the HIV status of the mother of the
p.001503: infant.
p.001503: (C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, in-
p.001503: cluding recommendations on removing the barriers identi- fied under subparagraph (B).
p.001503: If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another
p.001503: appropriate public or nonprofit private entity to conduct the study.
p.001503: (2) REPORT.—The Secretary shall ensure that, not later than 18 months after the effective date of this
p.001503: section, the study required in paragraph (1) is completed and a report de- scribing the findings made in the
p.001503: study is submitted to the ap- propriate committees of the Congress, the Secretary, and the chief public health
p.001503: official of each of the States.
p.001503: (b) PROGRESS TOWARD RECOMMENDATIONS.—In fiscal year 2004, the Secretary shall collect information
p.001503: from the States de- scribing the actions taken by the States toward meeting the rec- ommendations
p.001503: specified for the States under subsection (a)(1)(C).
p.001503: (c) SUBMISSION OF REPORTS TO CONGRESS.—The Secretary shall submit to the appropriate committees of the
p.001503: Congress reports describing the information collected under subsection (b).
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p.001503: Subpart III—Certain Partner Notification Programs
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p.001503: January 30, 2020
p.001503: SEC. 2631. ø300ff–38¿ GRANTS FOR PARTNER NOTIFICATION PRO- GRAMS.
p.001503: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001503: (b), the Secretary, subject to subsection (c)(2), may make grants to the States for carrying out programs to provide
p.001503: partner counseling and referral services.
p.001503: (b) DESCRIPTION OF COMPLIANT STATE PROGRAMS.—For pur- poses of subsection (a), the laws or regulations of a
p.001503: State are in ac- cordance with this subsection if under such laws or regulations (in- cluding programs carried out
p.001503: pursuant to the discretion of State of- ficials) the following policies are in effect:
p.001503: (1) The State requires that the public health officer of the State carry out a program of partner notification
p.001503: to inform partners of individuals with HIV/AIDS that the partners may have been exposed to the disease.
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001505: 1505
p.001505: PUBLIC HEALTH SERVICE ACT
p.001505: Sec. 2631
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p.001505: (2)(A) In the case of a health entity that provides for the performance on an individual of a test
p.001505: for HIV/AIDS, or that treats the individual for the disease, the State requires, subject to subparagraph (B),
p.001505: that the entity confidentially report the positive test results to the State public health officer in a man- ner
p.001505: recommended and approved by the Director of the Centers for Disease Control and Prevention, together with such
p.001505: addi- tional information as may be necessary for carrying out such program.
p.001505: (B) The State may provide that the requirement of sub- paragraph (A) does not apply to the testing of an
p.001505: individual for HIV/AIDS if the individual underwent the testing through a program designed to perform the
p.001505: test and provide the results to the individual without the individual disclosing his or her identity to
p.001505: the program. This subparagraph may not be con- strued as affecting the requirement of subparagraph (A)
p.001505: with respect to a health entity that treats an individual for HIV/ AIDS.
p.001505: (3) The program under paragraph (1) is carried out in ac- cordance with the following:
p.001505: (A) Partners are provided with an appropriate oppor- tunity to learn that the partners have been exposed
p.001505: to HIV/AIDS, subject to subparagraph (B).
p.001505: (B) The State does not inform partners of the identity of the infected individuals involved.
p.001505: (C) Counseling and testing for HIV/AIDS are made available to the partners and to infected individuals,
p.001505: and such counseling includes information on modes of trans- mission for the disease, including information
p.001505: on prenatal and perinatal transmission and preventing transmission.
p.001505: (D) Counseling of infected individuals and their part- ners includes the provision of information regarding
p.001505: thera- peutic measures for preventing and treating the deteriora- tion of the immune system and conditions arising from
p.001505: the disease, and the provision of other prevention-related in- formation.
p.001505: (E) Referrals for appropriate services are provided to partners and infected individuals, including
p.001505: referrals for support services and legal aid.
p.001505: (F) Notifications under subparagraph (A) are provided in person, unless doing so is an unreasonable burden on
p.001505: the State.
p.001505: (G) There is no criminal or civil penalty on, or civil li- ability for, an infected individual if the individual
p.001505: chooses not to identify the partners of the individual, or the indi- vidual does not otherwise cooperate
p.001505: with such program.
p.001505: (H) The failure of the State to notify partners is not a basis for the civil liability of any health entity
p.001505: who under the program reported to the State the identity of the in- fected individual involved.
p.001505: (I) The State provides that the provisions of the pro- gram may not be construed as prohibiting the
p.001505: State from providing a notification under subparagraph (A) without the consent of the infected individual
p.001505: involved.
p.001505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001505: Sec. 2651 PUBLIC HEALTH SERVICE ACT 1506
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p.001505: (4) The State annually reports to the Director of the Cen- ters for Disease Control and Prevention the number
p.001505: of individ- uals from whom the names of partners have been sought under the program under paragraph (1), the number of
p.001505: such individ- uals who provided the names of partners, and the number of partners so named who were notified
p.001505: under the program.
p.001505: (5) The State cooperates with such Director in carrying out a national program of partner notification, including the
p.001505: shar- ing of information between the public health officers of the States.
p.001505: (c) REPORTING SYSTEM FOR CASES OF HIV DISEASE; PREF- ERENCE IN MAKING GRANTS.—In making grants under
p.001505: subsection (a), the Secretary shall give preference to States whose reporting systems for cases of
p.001505: HIV/AIDS produce data on such cases that is sufficiently accurate and reliable for use for purposes of
p.001505: section 2618(a)(2)(D)(i).
p.001505: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001505: to be appropriated
p.001505: $10,000,000 for each of the fiscal years 2007 through 2009.
p.001505: PART C—EARLY INTERVENTION SERVICES
p.001505: Subpart I—Categorical Grants
p.001505: SEC. 2651. ø300ff–51¿ ESTABLISHMENT OF A PROGRAM.
p.001505: (a) IN GENERAL.—For the purposes described in subsection (b), the Secretary, acting through the Administrator of
p.001505: the Health Re- sources and Services Administration, may make grants to public and nonprofit private entities
p.001505: specified in section 2652(a).
p.001505: (b) REQUIREMENTS.—
p.001505: (1) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the applicant for the
p.001505: grant agrees to expend the grant only for—
p.001505: (A) core medical services described in subsection (c);
p.001505: (B) support services described in subsection (d); and
p.001505: (C) administrative expenses as described in section 2664(g)(3).
p.001505: (2) EARLY INTERVENTION SERVICES.—An applicant for a grant under subsection (a) shall expend not less
p.001505: than 50 per- cent of the amount received under the grant for the services described in subparagraphs (B)
p.001505: through (E) of subsection (e)(1) for individuals with HIV/AIDS.
p.001505: (c) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001505: (1) IN GENERAL.—With respect to a grant under subsection
p.001505: (a) to an applicant for a fiscal year, the applicant shall, of the portion of the grant remaining after reserving
p.001505: amounts for pur- poses of paragraphs (3) and (5) of section 2664(g), use not less than 75 percent to provide core
p.001505: medical services that are need- ed in the area involved for individuals with HIV/AIDS who are identified and eligible
p.001505: under this title (including services re- garding the co-occurring conditions of the individuals).
p.001505: (2) WAIVER.—
p.001505: (A) The Secretary shall waive the application of para- graph (1) with respect to an applicant for a grant if
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p.001507: 1507
p.001507: PUBLIC HEALTH SERVICE ACT
p.001507: Sec. 2651
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p.001507: Secretary determines that, within the service area of the applicant—
p.001507: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001507: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001507: this title.
p.001507: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing an applicant that a grant under subsection (a) is being
p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
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p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
p.001507: (A) counseling individuals with respect to HIV/AIDS in accordance with section 2662;
p.001507: (B) testing individuals with respect to HIV/AIDS, in- cluding tests to confirm the presence of the
p.001507: disease, tests to diagnose the extent of the deficiency in the immune sys-
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001507: Sec. 2652 PUBLIC HEALTH SERVICE ACT 1508
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p.001507: tem, and tests to provide information on appropriate therapeutic measures for preventing and treating the
p.001507: dete- rioration of the immune system and for preventing and treating conditions arising from HIV/AIDS;
p.001507: (C) referrals described in paragraph (2);
p.001507: (D) other clinical and diagnostic services regarding HIV/AIDS, and periodic medical evaluations of individuals
p.001507: with HIV/AIDS; and
p.001507: (E) providing the therapeutic measures described in subparagraph (B).
p.001507: (2) REFERRALS.—The services referred to in paragraph (1)(C) are referrals of individuals with
p.001507: HIV/AIDS to appro- priate providers of health and support services, including, as appropriate—
p.001507: (A) to entities receiving amounts under part A or B for the provision of such services;
p.001507: (B) to biomedical research facilities of institutions of higher education that offer experimental treatment
p.001507: for such disease, or to community-based organizations or other entities that provide such treatment; or
p.001507: (C) to grantees under section 2671, in the case of a pregnant woman.
p.001507: (3) REQUIREMENT OF AVAILABILITY OF ALL EARLY INTERVEN- TION SERVICES THROUGH EACH GRANTEE.—
p.001507: (A) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the applicant for
p.001507: the grant agrees that each of the early intervention services specified in paragraph (2) will be
p.001507: available through the grantee. With respect to compliance with such agreement, such a grantee may expend the grant to
p.001507: provide the early intervention services directly, and may expend the grant to enter into agreements with public or
p.001507: nonprofit private en- tities, or private for-profit entities if such entities are the only available
p.001507: provider of quality HIV care in the area, under which the entities provide the services.
p.001507: (B) OTHER REQUIREMENTS.—Grantees described in—
p.001507: (i) subparagraphs (A), (D), (E), and (F) of section 2652(a)(1) shall use not less than 50 percent of
p.001507: the amount of such a grant to provide the services de- scribed in subparagraphs (A), (B), (D), and (E) of
p.001507: para- graph (1) directly and on-site or at sites where other primary care services are rendered; and
p.001507: (ii) subparagraphs (B) and (C) of section 2652(a)(1) shall ensure the availability of early intervention serv- ices
p.001507: through a system of linkages to community-based primary care providers, and to establish mechanisms for the
p.001507: referrals described in paragraph (1)(C), and for follow-up concerning such referrals.
p.001507: SEC. 2652. ø300ff–52¿ MINIMUM QUALIFICATIONS OF GRANTEES.
p.001507: (a) ELIGIBLE ENTITIES.—
p.001507: (1) IN GENERAL.—The entities referred to in section 2651(a) are public entities and nonprofit private entities that
p.001507: are—
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p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
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p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
p.001509: accept reimbursement avail- able from any third-party payor, including reimbursement under any insurance
p.001509: policy or under any Federal or State health benefits program.
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p.001509: January 30, 2020
p.001509: 13 See footnote for section 217(a).
p.001509:
p.001509: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001509: Sec. 2653 PUBLIC HEALTH SERVICE ACT 1510
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p.001509: (B) A determination by the Secretary of whether an entity referred to in subparagraph (A) meets the
p.001509: criteria for a waiver under such subparagraph shall be made with- out regard to whether the entity accepts
p.001509: voluntary dona- tions regarding the provision of services to the public.
p.001509: SEC. 2653. ø300ff–53¿ PREFERENCES IN MAKING GRANTS.
p.001509: (a) IN GENERAL.—In making grants under section 2651, the Secretary shall give preference to any qualified
p.001509: applicant experi- encing an increase in the burden of providing services regarding HIV/AIDS, as indicated
p.001509: by the factors specified in subsection (b).
p.001509: (b) SPECIFICATION OF FACTORS.—
p.001509: (1) IN GENERAL.—In the case of the geographic area with respect to which the entity involved is
p.001509: applying for a grant under section 2651, the factors referred to in subsection (a), as determined for the period
p.001509: specified in paragraph (2), are—
p.001509: (A) the number of cases of HIV/AIDS;
p.001509: (B) the rate of increase in such cases;
p.001509: (C) the lack of availability of early intervention serv- ices;
p.001509: (D) the number of other cases of sexually transmitted diseases, and the number of cases of tuberculosis
p.001509: and of drug abuse and the number of cases of individuals co-in- fected with HIV/AIDS and hepatitis B or C;
p.001509: (E) the rate of increase in each of the cases specified in subparagraph (D);
p.001509: (F) the lack of availability of primary health services from providers other than such applicant; and
p.001509: (G) the distance between such area and the nearest community that has an adequate level of availability of ap-
p.001509: propriate HIV-related services, and the length of time re- quired to travel such distance.
p.001509: (2) RELEVANT PERIOD OF TIME.—The period referred to in paragraph (1) is the 2-year period preceding the fiscal
p.001509: year for which the entity involved is applying to receive a grant under section 2651.
p.001509: (c) EQUITABLE ALLOCATIONS.—In providing preferences for pur- poses of subsection (b), the Secretary shall
p.001509: equitably allocate the preferences among urban and rural areas.
p.001509: (d) CERTAIN AREAS.—Of the applicants who qualify for pref- erence under this section—
p.001509: (1) the Secretary shall give preference to applicants that will expend the grant under section 2651 to
p.001509: provide early intervention under such section in rural areas; and
p.001509: (2) the Secretary shall give preference to areas that are underserved with respect to such services.
p.001509: SEC. 2654. ø300ff–54¿ MISCELLANEOUS PROVISIONS.
p.001509: (a) SERVICES FOR INDIVIDUALS WITH HEMOPHILIA.—In making grants under section 2651, the Secretary shall
p.001509: ensure that any such grants made regarding the provision of early intervention services to individuals with
p.001509: hemophilia are made through the net- work of comprehensive hemophilia diagnostic and treatment cen- ters.
p.001509: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001511: 1511
p.001511: PUBLIC HEALTH SERVICE ACT
p.001511: Sec. 2655
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p.001511: (b) TECHNICAL ASSISTANCE.—The Secretary may, directly or through grants or contracts, provide technical
p.001511: assistance to non- profit private entities regarding the process of submitting to the Secretary applications
p.001511: for grants under section 2651, and may pro- vide technical assistance with respect to the planning, develop-
p.001511: ment, and operation of any program or service carried out pursuant to such section.
p.001511: (c) PLANNING AND DEVELOPMENT GRANTS.—
p.001511: (1) IN GENERAL.—The Secretary may provide planning grants to public and nonprofit private entities for
p.001511: purposes of—
p.001511: (A) enabling such entities to provide early intervention services; and
p.001511: (B) assisting the entities in expanding their capacity to provide HIV/AIDS-related health services,
p.001511: including early intervention services, in low-income communities and affected subpopulations that are underserved
p.001511: with respect to such services (subject to the condition that a grant pur- suant to this subparagraph may not be
p.001511: expended to pur- chase or improve land, or to purchase, construct, or perma- nently improve, other than minor
p.001511: remodeling, any building or other facility).
p.001511: (2) REQUIREMENT.—The Secretary may only award a grant to an entity under paragraph (1) if the Secretary
p.001511: determines that the entity will use such grant to assist the entity in quali- fying for a grant under section 2651.
p.001511: (3) PREFERENCE.—In awarding grants under paragraph (1), the Secretary shall give preference to entities that
p.001511: provide primary care services in rural areas or to underserved popu- lations.
p.001511: (4) AMOUNT AND DURATION OF GRANTS.—
p.001511: (A) EARLY INTERVENTION SERVICES.—A grant under paragraph (1)(A) may be made in an amount not to exceed
p.001511: $50,000.
p.001511: (B) CAPACITY DEVELOPMENT.—
p.001511: (i) AMOUNT.—A grant under paragraph (1)(B) may be made in an amount not to exceed $150,000.
p.001511: (ii) DURATION.—The total duration of a grant under paragraph (1)(B), including any renewal, may not
p.001511: exceed 3 years.
p.001511: (5) LIMITATION.—Not to exceed 5 percent of the amount appropriated for a fiscal year under section 2655 may be
p.001511: used to carry out this section.
p.001511: SEC. 2655. ø300ff–55¿ AUTHORIZATION OF APPROPRIATIONS.
p.001511: For the purpose of making grants under section 2651, there are authorized to be appropriated,
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p.001511: Subpart II—General Provisions
p.001511: SEC. 2661. ø300ff–61¿ CONFIDENTIALITY AND INFORMED CONSENT.
p.001511: (a) CONFIDENTIALITY.—The Secretary may not make a grant under this part unless, in the case of any
p.001511: entity applying for a grant under section 2651, the entity agrees to ensure that informa- tion regarding the receipt
p.001511: of early intervention services pursuant to the grant is maintained confidentially in a manner not inconsistent with
p.001511: applicable law.
p.001511: (b) INFORMED CONSENT.—The Secretary may not make a grant under this part unless the applicant for the grant
p.001511: agrees that, in testing an individual for HIV/AIDS, the applicant will test an indi- vidual only after the individual
p.001511: confirms that the decision of the in- dividual with respect to undergoing such testing is voluntarily made.
p.001511: SEC. 2662. ø300ff–62¿ PROVISION OF CERTAIN COUNSELING SERVICES.
p.001511: (a) COUNSELING OF INDIVIDUALS WITH NEGATIVE TEST RE- SULTS.—The Secretary may not make a grant
p.001511: under this part un- less the applicant for the grant agrees that, if the results of testing conducted for HIV/AIDS
p.001511: indicate that an individual does not have such condition, the applicant will provide the individual
p.001511: informa- tion, including—
p.001511: (1) measures for prevention of, exposure to, and trans- mission of HIV/AIDS, hepatitis B, hepatitis C, and
p.001511: other sexu- ally transmitted diseases;
p.001511: (2) the accuracy and reliability of results of testing for HIV/AIDS, hepatitis B, and hepatitis C;
p.001511: (3) the significance of the results of such testing, including the potential for developing AIDS, hepatitis B,
p.001511: or hepatitis C;
p.001511: (4) the appropriateness of further counseling, testing, and education of the individual regarding HIV/AIDS and
p.001511: other sex- ually transmitted diseases;
p.001511: (5) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001511: liver dis- ease and its impact on HIV/AIDS; and
p.001511: (6) information regarding the availability of hepatitis B vaccine and information about hepatitis treatments.
p.001511: (b) COUNSELING OF INDIVIDUALS WITH POSITIVE TEST RE- SULTS.—The Secretary may not make a
p.001511: grant under this part un- less the applicant for the grant agrees that, if the results of testing for HIV/AIDS
p.001511: indicate that the individual has such condition, the applicant will provide to the individual appropriate
p.001511: counseling re- garding the condition, including—
p.001511: (1) information regarding—
p.001511: (A) measures for prevention of, exposure to, and trans- mission of HIV/AIDS, hepatitis B, and hepatitis C;
p.001511: (B) the accuracy and reliability of results of testing for HIV/AIDS, hepatitis B, and hepatitis C; and
p.001511: (C) the significance of the results of such testing, in- cluding the potential for developing AIDS,
p.001511: hepatitis B, or hepatitis C;
p.001511: (2) reviewing the appropriateness of further counseling, testing, and education of the individual regarding
p.001511: HIV/AIDS and other sexually transmitted diseases; and
p.001511: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001513: 1513
p.001513: PUBLIC HEALTH SERVICE ACT
p.001513: Sec. 2663
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p.001513: (3) providing counseling—
p.001513: (A) on the availability, through the applicant, of early intervention services;
p.001513: (B) on the availability in the geographic area of appro- priate health care, mental health care, and social and sup-
p.001513: port services, including providing referrals for such serv- ices, as appropriate;
p.001513: (C)(i) that explains the benefits of locating and coun- seling any individual by whom the infected individual
p.001513: may have been exposed to HIV/AIDS, hepatitis B, or hepatitis C and any individual whom the infected
p.001513: individual may have exposed to HIV/AIDS, hepatitis B, or hepatitis C; and
p.001513: (ii) that emphasizes it is the duty of infected individ- uals to disclose their infected status to
p.001513: their sexual part- ners and their partners in the sharing of hypodermic nee- dles; that provides advice to
p.001513: infected individuals on the manner in which such disclosures can be made; and that emphasizes that it is
p.001513: the continuing duty of the individ- uals to avoid any behaviors that will expose others to HIV/ AIDS, hepatitis
p.001513: B, or hepatitis C; and
p.001513: (D) on the availability of the services of public health authorities with respect to locating and counseling
p.001513: any in- dividual described in subparagraph (C);
p.001513: (4) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001513: liver dis- ease and its impact on HIV/AIDS; and
p.001513: (5) information regarding the availability of hepatitis B vaccine.
p.001513: (c) ADDITIONAL REQUIREMENTS REGARDING APPROPRIATE COUN- SELING.—The Secretary may not make a grant under this part
p.001513: un- less the applicant for the grant agrees that, in counseling individ- uals with respect to HIV/AIDS,
p.001513: the applicant will ensure that the counseling is provided under conditions appropriate to the needs of the
p.001513: individuals.
p.001513: (d) COUNSELING OF EMERGENCY RESPONSE EMPLOYEES.—The Secretary may not make a grant under this part to a State
p.001513: unless the State agrees that, in counseling individuals with respect to HIV/AIDS, the State will ensure that,
p.001513: in the case of emergency re- sponse employees, the counseling is provided to such employees under conditions
p.001513: appropriate to the needs of the employees regard- ing the counseling.
p.001513: (e) RULE OF CONSTRUCTION REGARDING COUNSELING WITHOUT TESTING.—Agreements made pursuant to this section may
p.001513: not be construed to prohibit any grantee under this part from expending the grant for the purpose of
p.001513: providing counseling services described in this section to an individual who does not undergo testing for
p.001513: HIV/AIDS as a result of the grantee or the individual determining that such testing of the individual is not
p.001513: appropriate.
p.001513: SEC. 2663. ø300ff–63¿ APPLICABILITY OF REQUIREMENTS REGARDING CONFIDENTIALITY, INFORMED CONSENT, AND
p.001513: COUN- SELING.
p.001513: The Secretary may not make a grant under this part unless the applicant for the grant agrees that,
p.001513: with respect to testing for HIV/AIDS, any such testing carried out by the applicant with funds
p.001513: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001513: Sec. 2664 PUBLIC HEALTH SERVICE ACT 1514
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p.001513: January 30, 2020
p.001513:
p.001513: appropriated through this Act will be carried out in accordance with conditions described in sections 2661 and
p.001513: 2662.
p.001513: SEC. 2664. ø300ff–64¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001513: (a) REPORTS TO SECRETARY.—The Secretary may not make a grant under this part unless—
p.001513: (1) the applicant submits to the Secretary—
p.001513: (A) a specification of the expenditures made by the ap- plicant for early intervention services for the fiscal
p.001513: year preceding the fiscal year for which the applicant is apply- ing to receive the grant;
p.001513: (B) an estimate of the number of individuals to whom the applicant has provided such services for such fiscal
p.001513: year;
p.001513: (C) information regarding how the expected expendi- tures of the grant are related to the planning
p.001513: process for localities funded under part A (including the planning process described in section 2602) and
p.001513: for States funded under part B (including the planning process described in section 2617(b)); and
p.001513: (D) a specification of the expected expenditures and how those expenditures will improve overall client
p.001513: out- comes, as described in the State plan under section 2617(b);
p.001513: (2) the applicant agrees to submit to the Secretary a report providing—
p.001513: (A) the number of individuals to whom the applicant provides early intervention services pursuant to the grant;
p.001513: (B) epidemiological and demographic data on the pop- ulation of such individuals;
p.001513: (C) the extent to which the costs of HIV-related health care for such individuals are paid by third-party payors;
p.001513: (D) the average costs of providing each category of early intervention service; and
p.001513: (E) the aggregate amounts expended for each such cat- egory;
p.001513: (3) the applicant agrees to provide additional documenta- tion to the Secretary regarding the process used to
p.001513: obtain com- munity input into the design and implementation of activities related to such grant; and
p.001513: (4) the applicant agrees to submit, every 2 years, to the lead State agency under section 2617(b)(4)
p.001513: audits, consistent with Office of Management and Budget circular A133, regard- ing funds expended in
p.001513: accordance with this title and shall in- clude necessary client level data to complete unmet need cal-
p.001513: culations and Statewide coordinated statements of need proc- ess.
p.001513: (b) PROVISION OF OPPORTUNITIES FOR ANONYMOUS COUNSELING AND TESTING.—The Secretary may not make a grant
p.001513: under this part unless the applicant for the grant agrees that, to the extent permitted under State law,
p.001513: regulation or rule, the applicant will offer substantial opportunities for an individual—
p.001513: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001515: 1515
p.001515: PUBLIC HEALTH SERVICE ACT
p.001515: Sec. 2664
p.001515:
p.001515: (1) to undergo counseling and testing regarding HIV/AIDS without being required to provide any information
p.001515: relating to the identity of the individual; and
p.001515: (2) to undergo such counseling and testing through the use of a pseudonym.
p.001515: (c) PROHIBITION AGAINST REQUIRING TESTING AS CONDITION OF RECEIVING OTHER HEALTH SERVICES.—The
p.001515: Secretary may not make a grant under this part unless the applicant for the grant agrees that, with
p.001515: respect to an individual seeking health services from the applicant, the applicant will not require the
p.001515: individual to undergo testing for HIV as a condition of receiving any health serv- ices unless such testing is
p.001515: medically indicated in the provision of the health services sought by the individual.
p.001515: (d) MAINTENANCE OF SUPPORT.—The Secretary may not make a grant under this part unless the
p.001515: applicant for the grant agrees to maintain the expenditures of the applicant for early intervention services at a
p.001515: level equal to not less than the level of such expendi- tures maintained by the State for the fiscal year preceding the
p.001515: fis- cal year for which the applicant is applying to receive the grant.
p.001515: (e) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001515: SERVICES.—
p.001515: (1) IN GENERAL.—The Secretary may not make a grant under this part unless, subject to paragraph (5), the
p.001515: applicant for the grant agrees that—
p.001515: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the ap-
p.001515: plicant will not impose a charge on any such individual for the provision of early intervention services
p.001515: under the grant;
p.001515: (B) in the case of individuals with an income greater than 100 percent of the official poverty line,
p.001515: the appli- cant—
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p.001515: January 30, 2020
p.001515: (i) will impose a charge on each such individual for the provision of such services; and
p.001515: (ii) will impose the charge according to a schedule of charges that is made available to the public.
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p.001517: 1517
p.001517: PUBLIC HEALTH SERVICE ACT
p.001517: Sec. 2666
p.001517:
p.001517: (g) ADMINISTRATION OF GRANT.—The Secretary may not make a grant under this part unless the
p.001517: applicant for the grant agrees that—
p.001517: (1) the applicant will not expend amounts received pursu- ant to this part for any purpose other than
p.001517: the purposes de- scribed in the subpart under which the grant involved is made;
p.001517: (2) the applicant will establish such procedures for fiscal control and fund accounting as may be
p.001517: necessary to ensure proper disbursement and accounting with respect to the grant;
p.001517: (3) the applicant will not expend more than 10 percent of the grant for administrative expenses
p.001517: with respect to the grant, including planning and evaluation, except that the costs of a clinical quality
p.001517: management program under paragraph (5) may not be considered administrative expenses for purposes of such limitation;
p.001517: (4) the applicant will submit evidence that the proposed program is consistent with the statewide
p.001517: coordinated state- ment of need and agree to participate in the ongoing revision of such statement of need;
p.001517: and
p.001517: (5) the applicant will provide for the establishment of a clinical quality management program—
p.001517: (A) to assess the extent to which medical services funded under this title that are provided to
p.001517: patients are consistent with the most recent Public Health Service guidelines for the treatment of
p.001517: HIV/AIDS and related op- portunistic infections, and as applicable, to develop strate- gies for ensuring that such
p.001517: services are consistent with the guidelines; and
p.001517: (B) to ensure that improvements in the access to and quality of HIV health services are addressed.
p.001517: SEC. 2665. ø300ff–65¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001517: The Secretary may not make a grant under this part unless—
p.001517: (1) an application for the grant is submitted to the Sec- retary containing agreements and assurances in
p.001517: accordance with this part and containing the information specified in sec- tion 2664(a)(1);
p.001517: (2) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001517: the Secretary; and
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p.001517: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001517: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001517: SEC. 2666. ø300ff–66¿ PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
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p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001519: 1519
p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
p.001519: elimination of risk of HIV/AIDS for youth.
p.001519: (2) The applicant will participate in the statewide coordi- nated statement of need under part B (where it has
p.001519: been initi- ated by the public health agency responsible for administering grants under part B) and in revisions of
p.001519: such statement.
p.001519: (3) The applicant will every 2 years submit to the lead State agency under section 2617(b)(4) audits
p.001519: regarding funds expended in accordance with this title and shall include nec- essary client-level data to
p.001519: complete unmet need calculations and Statewide coordinated statements of need process.
p.001519: (d) ADMINISTRATION; APPLICATION.—A grant may only be awarded to an entity under subsection (a) if an
p.001519: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001519: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001519: be nec- essary to carry out this section. Such application shall include the following:
p.001519: (1) Information regarding how the expected expenditures of the grant are related to the planning process
p.001519: for localities funded under part A (including the planning process outlined in section 2602) and for States
p.001519: funded under part B (including the planning process outlined in section 2617(b)).
p.001519: (2) A specification of the expected expenditures and how those expenditures will improve overall patient
p.001519: outcomes, as outlined as part of the State plan (under section 2617(b)) or through additional outcome
p.001519: measures.
p.001519: (e) ANNUAL REVIEW OF PROGRAMS; EVALUATIONS.—
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p.001519: the development of recommendations, as appropriate, for improvements in the fol- lowing:
p.001519: (A) Procedures used by the entity to allocate opportu- nities and services under subsection (a) among patients
p.001519: of the entity who are women, infants, children, or youth.
p.001519: (B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
p.001519: (2) EVALUATIONS.—— 14The Secretary shall, directly or through contracts with public and private
p.001519: entities, provide for evaluations of programs carried out pursuant to subsection (a).
p.001519: (f) ADMINISTRATIVE EXPENSES.—
p.001519: (1) LIMITATION.—A grantee may not use more than 10 per- cent of amounts received under a grant awarded under
p.001519: this section for administrative expenses.
p.001519:
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p.001519: January 30, 2020
p.001519: 14 Dash so in law.
p.001519:
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001519: Sec. 2681 PUBLIC HEALTH SERVICE ACT 1520
p.001519:
p.001519: (2) CLINICAL QUALITY MANAGEMENT PROGRAM.—A grantee under this section shall implement a clinical quality
p.001519: manage- ment program to assess the extent to which HIV health serv- ices provided to patients under the
p.001519: grant are consistent with the most recent Public Health Service guidelines for the treat- ment of HIV/AIDS and
p.001519: related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are
p.001519: consistent with the guidelines for improvement in the ac- cess to and quality of HIV health services.
p.001519: (g) TRAINING AND TECHNICAL ASSISTANCE.—From the amounts appropriated under subsection (j) for a fiscal year,
p.001519: the Secretary may use not more than 5 percent to provide, directly or through contracts with public
p.001519: and private entities (which may include grantees under subsection (a)), training and technical assistance to
p.001519: assist applicants and grantees under subsection (a) in complying with the requirements of this section.
p.001519: (h) DEFINITIONS.—In this section:
p.001519: (1) ADMINISTRATIVE EXPENSES.—The term ‘‘administrative expenses’’ means funds that are to be used by
p.001519: grantees for grant management and monitoring activities, including costs related to any staff or activity
p.001519: unrelated to services or indirect costs.
p.001519: (2) INDIRECT COSTS.—The term ‘‘indirect costs’’ means costs included in a Federally negotiated indirect rate.
p.001519: (3) SERVICES.—The term ‘‘services’’ means—
p.001519: (A) services that are provided to clients to meet the goals and objectives of the program under this section,
p.001519: in- cluding the provision of professional, diagnostic, and thera- peutic services by a primary care provider or a
p.001519: referral to and provision of specialty care; and
p.001519: (B) services that sustain program activity and con- tribute to or help improve services under
p.001519: subparagraph (A).
p.001519: (i) APPLICATION TO PRIMARY CARE SERVICES.—Nothing in this part shall be construed as requiring funds
p.001519: under this part to be used for primary care services when payments are available for such services from
p.001519: other sources (including under titles XVIII, XIX, and XXI of the Social Security Act).
p.001519: (j) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001519: to be appropriated,
p.001519: $71,800,000 for each of the fiscal years 2007 through 2009,
p.001519: $75,390,000 for fiscal year 2010, $79,160,000 for fiscal year 2011,
p.001519: $83,117,000 for fiscal year 2012, and $87,273,000 for fiscal year 2013.
p.001519:
p.001519: PART E—GENERAL PROVISIONS
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p.001519: SEC. 2681. ø300ff–81¿ COORDINATION.
p.001519: (a) REQUIREMENT.—The Secretary shall ensure that the Health Resources and Services Administration, the Centers
p.001519: for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the
p.001519: Centers for Medicare & Medicaid Services coordinate the planning, funding, and implementation of Federal HIV
p.001519: programs (including all minority AIDS initiatives of
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001521: 1521
p.001521: PUBLIC HEALTH SERVICE ACT
p.001521: Sec. 2683
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p.001521: January 30, 2020
p.001521: the Public Health Service, including under section 2693) to enhance the continuity of care and prevention
p.001521: services for individuals with HIV/AIDS or those at risk of such disease. The Secretary shall con- sult with other
p.001521: Federal agencies, including the Department of Vet- erans Affairs, as needed and utilize planning information
p.001521: sub- mitted to such agencies by the States and entities eligible for as- sistance under this title.
p.001521: (b) REPORT.—The Secretary shall biennially prepare and sub- mit to the appropriate committees of the
p.001521: Congress a report con- cerning the coordination efforts at the Federal, State, and local lev- els described in this
p.001521: section, including a description of Federal bar- riers to HIV program integration and a strategy for
p.001521: eliminating such barriers and enhancing the continuity of care and prevention services for individuals with HIV/AIDS or
p.001521: those at risk of such dis- ease.
p.001521: (c) INTEGRATION BY STATE.—As a condition of receipt of funds under this title, a State shall provide
p.001521: assurances to the Secretary that health support services funded under this title will be inte- grated with
p.001521: other such services, that programs will be coordinated with other available programs (including Medicaid), and
p.001521: that the continuity of care and prevention services of individuals with HIV/ AIDS is enhanced.
p.001521: (d) INTEGRATION BY LOCAL OR PRIVATE ENTITIES.—As a condi- tion of receipt of funds under this title, a
p.001521: local government or pri- vate nonprofit entity shall provide assurances to the Secretary that services funded
p.001521: under this title will be integrated with other such services, that programs will be coordinated with
p.001521: other available programs (including Medicaid), and that the continuity of care and prevention services of individuals
p.001521: with HIV is enhanced.
p.001521: SEC. 2682. ø300ff–82¿ AUDITS.
p.001521: (a) IN GENERAL.—For fiscal year 2009, and each subsequent fiscal year, the Secretary may reduce the amounts of
p.001521: grants under this title to a State or political subdivision of a State for a fiscal year if, with
p.001521: respect to such grants for the second preceding fiscal year, the State or subdivision fails to prepare audits
p.001521: in accordance with the procedures of section 7502 of title 31, United States Code. The Secretary shall annually select
p.001521: representative samples of such audits, prepare summaries of the selected audits, and submit the summaries to
p.001521: the Congress.
p.001521: (b) POSTING ON THE INTERNET.—All audits that the Secretary receives from the State lead agency under
p.001521: section 2617(b)(4) shall be posted, in their entirety, on the Internet website of the Health Resources and
p.001521: Services Administration.
p.001521: SEC. 2683. ø300ff–83¿ PUBLIC HEALTH EMERGENCY.
p.001521: (a) IN GENERAL.—In an emergency area and during an emer- gency period, the Secretary shall have the authority
p.001521: to waive such requirements of this title to improve the health and safety of those receiving care under this title
p.001521: and the general public, except that the Secretary may not expend more than 5 percent of the funds al- located
p.001521: under this title for sections 2620 and section 2603(b).
p.001521: (b) EMERGENCY AREA AND EMERGENCY PERIOD.—In this sec- tion:
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p.001521: (2) EMERGENCY PERIOD.—The term ‘‘emergency period’’ means the period in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (c) UNOBLIGATED FUNDS.—If funds under a grant under this section are not expended for an emergency in
p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
p.001521: include a history of program activities within each relevant agency and a description of activi- ties
p.001521: conducted, people served and types of grantees funded, and shall collect and describe best practices in
p.001521: community outreach and capacity-building of community based organizations serving the communities that are
p.001521: disproportionately affected by HIV/AIDS.
p.001521: SEC. 2687. ø300ff–87¿ SEVERITY OF NEED INDEX.
p.001521: (a) DEVELOPMENT OF INDEX.—Not later than September 30, 2008, the Secretary shall develop and submit to
p.001521: the appropriate
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p.001523: 1523
p.001523: PUBLIC HEALTH SERVICE ACT
p.001523: Sec. 2688
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p.001523: January 30, 2020
p.001523: committees of Congress a severity of need index in accordance with subsection (c).
p.001523: (b) DEFINITION OF SEVERITY OF NEED INDEX.—In this section, the term ‘‘severity of need index’’ means the
p.001523: index of the relative needs of individuals within a State or area, as identified by a num- ber of different
p.001523: factors, and is a factor or set of factors that is mul- tiplied by the number of living HIV/AIDS cases in a State or
p.001523: area, providing different weights to those cases based on needs. Such fac- tors or set of factors may be
p.001523: different for different components of the provisions under this title.
p.001523: (c) REQUIREMENTS FOR SECRETARIAL SUBMISSION.—When the Secretary submits to the appropriate committees of
p.001523: Congress the severity of need index under subsection (a), the Secretary shall pro- vide the following:
p.001523: (1) Methodology for and rationale behind developing the severity of need index, including information
p.001523: related to the field testing of the severity of need index.
p.001523: (2) An independent contractor analysis of activities carried out under paragraph (1).
p.001523: (3) Information regarding the process by which the Sec- retary received community input regarding the
p.001523: application and development of the severity of need index.
p.001523: (d) ANNUAL REPORTS.—If the Secretary fails to submit the se- verity of need index under subsection (a)
p.001523: in either of fiscal years 2007 or 2008, the Secretary shall prepare and submit to the appro- priate committees of
p.001523: Congress a report for such fiscal year—
p.001523: (1) that updates progress toward having client level data;
p.001523: (2) that updates the progress toward having a severity of need index, including information related to
p.001523: the methodology and process for obtaining community input; and
p.001523: (3) that, as applicable, states whether the Secretary could develop a severity of need index before fiscal year
p.001523: 2009.
p.001523: SEC. 2688. ø300ff–87a¿ NATIONAL HIV/AIDS TESTING GOAL.
p.001523: (a) IN GENERAL.—Not later than January 1, 2010, the Sec- retary shall establish a national HIV/AIDS
p.001523: testing goal of 5,000,000 tests for HIV/AIDS annually through federally-supported HIV/AIDS prevention,
p.001523: treatment, and care programs, including programs under this title and other programs administered by the Centers
p.001523: for Disease Control and Prevention.
p.001523: (b) ANNUAL REPORT.—Not later than January 1, 2011, and an- nually thereafter, the Secretary, acting through the
p.001523: Director of the Centers for Disease Control and Prevention, shall submit to Con- gress a report describing,
p.001523: with regard to the preceding 12-month reporting period—
p.001523: (1) whether the testing goal described in subsection (a) has been met;
p.001523: (2) the total number of individuals tested through feder- ally-supported and other HIV/AIDS prevention,
p.001523: treatment, and care programs in each State;
p.001523: (3) the number of individuals who—
p.001523: (A) prior to such 12-month period, were unaware of their HIV status; and
p.001523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001523: Sec. 2689 PUBLIC HEALTH SERVICE ACT 1524
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p.001523: (B) through federally-supported and other HIV/AIDS prevention, treatment, and care programs, were diagnosed and
p.001523: referred into treatment and care during such period;
p.001523: (4) any barriers, including State laws and regulations, that the Secretary determines to be a barrier to meeting the
p.001523: testing goal described in subsection (a);
p.001523: (5) the amount of funding the Secretary determines nec- essary to meet the annual testing goal in the
p.001523: following 12 months and the amount of Federal funding expended to meet the testing goal in the prior 12-month
p.001523: period; and
p.001523: (6) the most cost-effective strategies for identifying and di- agnosing individuals who were unaware of their
p.001523: HIV status, including voluntary testing with pre-test counseling, routine screening including opt-out testing,
p.001523: partner counseling and re- ferral services, and mass media campaigns.
p.001523: (c) REVIEW OF PROGRAM EFFECTIVENESS.—Not later than 1 year after the date of enactment of this
p.001523: section, the Secretary, in consultation with the Director of the Centers for Disease Control and
p.001523: Prevention, shall submit a report to Congress based on a com- prehensive review of each of the programs and activities
p.001523: conducted by the Centers for Disease Control and Prevention as part of the Domestic HIV/AIDS Prevention
p.001523: Activities, including the following:
p.001523: (1) The amount of funding provided for each program or activity.
p.001523: (2) The primary purpose of each program or activity.
p.001523: (3) The annual goals for each program or activity.
p.001523: (4) The relative effectiveness of each program or activity with relation to the other programs and activities
p.001523: conducted by the Centers for Disease Control and Prevention, based on the—
p.001523: (A) number of previously undiagnosed individuals with HIV/AIDS made aware of their status and referred into the
p.001523: appropriate treatment;
p.001523: (B) amount of funding provided for each program or activity compared to the number of undiagnosed
p.001523: individ- uals with HIV/AIDS made aware of their status;
p.001523: (C) program’s contribution to the National HIV/AIDS testing goal; and
p.001523: (D) progress made toward the goals described in para- graph (3).
p.001523: (5) Recommendations if any to Congress on ways to allo- cate funding for domestic HIV/AIDS prevention
p.001523: activities and programs in order to achieve the National HIV/AIDS testing goal.
p.001523: (d) COORDINATION WITH OTHER FEDERAL ACTIVITIES.—In pur- suing the National HIV/AIDS testing goal, the Secretary,
p.001523: where ap- propriate, shall consider and coordinate with other national strate- gies conducted by the Federal
p.001523: Government to address HIV/AIDS.
p.001523: SEC. 2689. ø300ff–88¿ DEFINITIONS.
p.001523: For purposes of this title:
p.001523: (1) AIDS.—The term ‘‘AIDS’’ means acquired immune defi- ciency syndrome.
p.001523: (2) CO-OCCURRING CONDITIONS.—The term ‘‘co-occurring conditions’’ means one or more adverse health conditions
p.001523: in an
p.001523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: 1525
p.001525: PUBLIC HEALTH SERVICE ACT
p.001525: Sec. 2689
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p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
p.001525: (C) NON-AIDS CASES.—The term ‘‘non-AIDS’’, with re- spect to a case of HIV, means that the individual involved
p.001525: has HIV but does not have AIDS.
p.001525: (8) HUMAN IMMUNODEFICIENCY VIRUS.—The term ‘‘human immunodeficiency virus’’ means the etiologic agent for AIDS.
p.001525: (9) OFFICIAL POVERTY LINE.—The term ‘‘official poverty line’’ means the poverty line established by the Director
p.001525: of the Office of Management and Budget and revised by the Secretary in accordance with section 673(2) of the Omnibus
p.001525: Budget Rec- onciliation Act of 1981.
p.001525: (10) PERSON.—The term ‘‘person’’ includes one or more in- dividuals, governments (including the Federal Government and
p.001525: the governments of the States), governmental agencies, polit- ical subdivisions, labor unions, partnerships,
p.001525: associations, cor- porations, legal representatives, mutual companies, joint-stock companies, trusts,
p.001525: unincorporated organizations, receivers, trustees, and trustees in cases under title 11, United States
p.001525: Code.
p.001525: (11) STATE.—
p.001525: (A) IN GENERAL.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and each of the
p.001525: terri- tories.
p.001525: (B) TERRITORIES.—The term ‘‘territory’’ means each of American Samoa, Guam, the Commonwealth of Puerto
p.001525: Rico, the Commonwealth of the Northern Mariana Islands,
p.001525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: Sec. 2691 PUBLIC HEALTH SERVICE ACT 1526
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p.001525: the Virgin Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau.
p.001525: (12) YOUTH WITH HIV.—The term ‘‘youth with HIV’’ means individuals who are 13 through 24 years old and who
p.001525: have HIV/AIDS.
p.001525: PART F—DEMONSTRATION AND TRAINING
p.001525: Subpart I—Special Projects of National Significance
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p.001525: SEC. 2691. ø300ff–101¿ SPECIAL PROJECTS OF NATIONAL SIGNIFI- CANCE.
p.001525: (a) IN GENERAL.—Of the amount appropriated under each of parts A, B, C, and D for each fiscal year,
p.001525: the Secretary shall use the greater of $20,000,000 or an amount equal to 3 percent of such amount appropriated
p.001525: under each such part, but not to exceed
p.001525: $25,000,000, to administer special projects of national significance to—
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p.001525: January 30, 2020
p.001525: (1) quickly respond to emerging needs of individuals re- ceiving assistance under this title; and
p.001525: (2) to fund special programs to develop a standard elec- tronic client information data system to
p.001525: improve the ability of grantees under this title to report client-level data to the Sec- retary.
p.001525: (b) GRANTS.—The Secretary shall award grants under sub- section (a) to entities eligible for funding under parts
p.001525: A, B, C, and D based on—
p.001525: (1) whether the funding will promote obtaining client level data as it relates to the creation of a severity
p.001525: of need index, including funds to facilitate the purchase and enhance the uti- lization of qualified health
p.001525: information technology systems;
p.001525: (2) demonstrated ability to create and maintain a qualified health information technology system;
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p.001525: the system will, at a minimum, comply
p.001525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527: Sec. 2692
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p.001527: with the privacy regulations promulgated under section 264(c) of the Health Insurance Portability and
p.001527: Accountability Act of 1996.
p.001527: (e) REPLICATION.—The Secretary shall make information con- cerning successful models or programs developed
p.001527: under this part available to grantees under this title for the purpose of coordina- tion, replication,
p.001527: and integration. To facilitate efforts under this subsection, the Secretary may provide for peer-based
p.001527: technical as- sistance for grantees funded under this part.
p.001527: Subpart II—AIDS Education and Training Centers
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p.001527: SEC. 2692. ø300ff–111¿ HIV/AIDS COMMUNITIES, SCHOOLS, AND CEN- TERS.
p.001527: (a) SCHOOLS; CENTERS.—
p.001527: (1) IN GENERAL.—The Secretary may make grants and enter into contracts to assist public and nonprofit private
p.001527: enti- ties and schools and academic health science centers in meet- ing the costs of projects—
p.001527: (A) to train health personnel, including practitioners in programs under this title and other community
p.001527: pro- viders, in the diagnosis, treatment, and prevention of HIV/ AIDS, including the prevention of the perinatal
p.001527: trans- mission of the disease, including measures for the preven- tion and treatment of opportunistic infections, and
p.001527: includ- ing (as applicable to the type of health professional in- volved), prenatal and other
p.001527: gynecological care for women with HIV/AIDS;
p.001527: (B) to train the faculty of schools of, and graduate de- partments or programs of, medicine, nursing, osteopathic
p.001527: medicine, dentistry, public health, allied health, and men- tal health practice to teach health professions
p.001527: students to provide for the health care needs of individuals with HIV/ AIDS;
p.001527: (C) to develop and disseminate curricula and resource materials relating to the care and treatment of individuals with
p.001527: such disease and the prevention of the disease among individuals who are at risk of contracting the disease; and
p.001527: (D) to develop protocols for the medical care of women with HIV/AIDS, including prenatal and other gynecological care
p.001527: for such women.
p.001527: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.001527: preference to qualified projects which will—
p.001527: (A) train, or result in the training of, health profes- sionals who will provide treatment for minority
p.001527: individuals and Native Americans with HIV/AIDS and other individ- uals who are at high risk of contracting such
p.001527: disease;
p.001527: (B) train, or result in the training of, minority health professionals and minority allied health
p.001527: professionals to provide treatment for individuals with such disease; and
p.001527: (C) train or result in the training of health profes- sionals and allied health professionals to provide
p.001527: treat- ment for hepatitis B or C co-infected individuals.
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527: Sec. 2692 PUBLIC HEALTH SERVICE ACT 1528
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p.001527: (3) APPLICATION.—No grant or contract may be made under paragraph (1) unless an application is
p.001527: submitted to the Secretary in such form, at such time, and containing such in- formation, as the Secretary
p.001527: may prescribe.
p.001527: (b) DENTAL SCHOOLS.—
p.001527: (1) IN GENERAL.—
p.001527: (A) GRANTS.—The Secretary may make grants to den- tal schools and programs described in subparagraph (B) to assist
p.001527: such schools and programs with respect to oral health care to patients with HIV/AIDS.
p.001527: (B) ELIGIBLE APPLICANTS.—For purposes of this sub- section, the dental schools and programs referred to in this
p.001527: subparagraph are dental schools and programs that were described in section 777(b)(4)(B) as such section was in
p.001527: ef- fect on the day before the date of the enactment of the Health Professions Education Partnerships
p.001527: Act of 1998 (Public Law 105–392) and in addition dental hygiene pro- grams that are accredited by the
p.001527: Commission on Dental Accreditation.
p.001527: (2) APPLICATION.—Each dental school or program described in section 15 the section referred to in paragraph (1)(B)
p.001527: may an- nually submit an application documenting the unreimbursed costs of oral health care provided to
p.001527: patients with HIV/AIDS by that school or hospital during the prior year.
p.001527: (3) DISTRIBUTION.—The Secretary shall distribute the available funds among all eligible applicants,
p.001527: taking into ac- count the number of patients with HIV/AIDS served and the unreimbursed oral health care
p.001527: costs incurred by each institu- tion as compared with the total number of patients served and costs incurred by all
p.001527: eligible applicants.
p.001527: (4) MAINTENANCE OF EFFORT.—The Secretary shall not make a grant under this subsection if doing so would result in
p.001527: any reduction in State funding allotted for such purposes.
p.001527: (5) COMMUNITY-BASED CARE.—The Secretary may make grants to dental schools and programs described in
p.001527: paragraph (1)(B) that partner with community-based dentists to provide oral health care to patients with
p.001527: HIV/AIDS in unserved areas. Such partnerships shall permit the training of dental students and residents and the
p.001527: participation of community dentists as adjunct faculty.
p.001527: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001527: (1) SCHOOLS; CENTERS.—For the purpose of awarding grants under subsection (a), there are authorized
p.001527: to be appro- priated $34,700,000 for each of the fiscal years 2007 through 2009, $36,535,000 for fiscal
p.001527: year 2010, $38,257,000 for fiscal year 2011, $40,170,000 for fiscal year 2012, and $42,178,000 for fiscal
p.001527: year 2013.
p.001527: (2) DENTAL SCHOOLS.—For the purpose of awarding grants under subsection (b), there are authorized to be
p.001527: appropriated
p.001527: $13,000,000 for each of the fiscal years 2007 through 2009,
p.001527: $13,650,000 for fiscal year 2010, $14,333,000 for fiscal year
p.001527:
p.001527:
p.001527:
p.001527: January 30, 2020
p.001527: 15 So in law. See section 402(b)(2) of Public Law 106–345 (114 Stat. 1349).
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001527:
p.001527:
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p.001529: 1529
p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
p.001529:
p.001529:
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001529: Sec. 2693 PUBLIC HEALTH SERVICE ACT 1530
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p.001529:
p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
p.001529:
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p.001531: 1531
p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
p.001531:
p.001531: (1) The schedule for carrying out subsection (b)(1)(A) shall be the same as the schedule applicable to emergency
p.001531: assistance under part A.
p.001531: (2) The schedule for carrying out subsection (b)(1)(B) shall be the same as the schedule applicable to care
p.001531: grants under part B.
p.001531: (3) The schedule for carrying out subsection (b)(1)(C) shall be the same as the schedule applicable to grants
p.001531: for early intervention services under part C.
p.001531: (4) The schedule for carrying out subsection (b)(1)(D) shall be the same as the schedule applicable to grants
p.001531: for services through projects for HIV-related care under part D.
p.001531: (5) The schedule for carrying out subsection (b)(1)(E) shall be the same as the schedule applicable to grants and
p.001531: contracts for activities through education and training centers under sec- tion 2692.
p.001531:
p.001531: PART G—NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES
p.001531:
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p.001531: January 30, 2020
p.001531: SEC. 2695. ø300ff–131¿ INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT TO NOTIFICATION REQUIREMENTS.
p.001531: (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this part, the Secretary shall
p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
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p.000001: 43 PUBLIC HEALTH SERVICE ACT Sec. 225
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p.000001: January 30, 2020
p.000001: (D) Subsection (g)(1)(F) applies to a health care practi- tioner for purposes of this subsection only to
p.000001: the extent that, in providing health services to an individual, each of the condi- tions specified in paragraph (2)
p.000001: is met.
p.000001: (4)(A) Amounts in the fund established under subsection (k)(2) shall be available for transfer under subparagraph (C)
p.000001: for purposes of carrying out this subsection.
p.000001: (B)(i) Not later than May 1 of each fiscal year, the Attorney General, in consultation with the
p.000001: Secretary, shall submit to the Congress a report providing an estimate of the amount of claims (together
p.000001: with related fees and expenses of witnesses) that, by rea- son of the acts or omissions of health professional
p.000001: volunteers, will be paid pursuant to this section during the calendar year that be- gins in the following
p.000001: fiscal year.
p.000001: (ii) Subsection (k)(1)(B) applies to the estimate under clause (i) regarding health professional volunteers to the same
p.000001: extent and in the same manner as such subsection applies to the estimate under such subsection regarding officers,
p.000001: governing board members, em- ployees, and contractors of entities described in subsection (g)(4).
p.000001: (iii) The report shall include a summary of the data relied upon for the estimate in clause (i), including the
p.000001: number of claims filed and paid from the previous calendar year.
p.000001: (C) Not later than December 31 of each fiscal year, the Sec- retary shall transfer from the fund under
p.000001: subsection (k)(2) to the appropriate accounts in the Treasury an amount equal to the esti- mate made under
p.000001: subparagraph (B) for the calendar year begin- ning in such fiscal year, subject to the extent of
p.000001: amounts in the fund.
p.000001: (5)(A) This subsection shall take effect on October 1, 2017, ex- cept as provided in subparagraph (B) and paragraph
p.000001: (6).
p.000001: (B) Effective on the date of the enactment of this subsection—
p.000001: (i) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and
p.000001: consider ap- plications submitted pursuant to paragraph (3)(B); and
p.000001: (ii) reports under paragraph (4)(B) may be submitted to Congress.
p.000001: (6) Beginning on October 1, 2022, this subsection shall cease to have any force or effect.
p.000001: SEC. 225. ø234¿ HEALTH CARE PROFESSIONALS ASSISTING DURING A PUBLIC HEALTH EMERGENCY.
p.000001: (a) LIMITATION ON LIABILITY.—Notwithstanding any other pro- vision of law, a health care professional who is a
p.000001: member of the Medical Reserve Corps under section 2813 or who is included in the Emergency System
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p.001621: Secretary) for activities funded through awards pursuant to sections 319C–1 and 319C–2, and an analysis of any
p.001621: changes to the evidence-based benchmarks and objective standards under sections 319C–1 and 319C–2.
p.001621: (3) PUBLIC HEALTH WORKFORCE.—In 2022, the National Health Security Strategy shall include a national
p.001621: strategy for establishing an effective and prepared public health workforce, including defining the functions,
p.001621: capabilities, and gaps in such workforce (including gaps in the environmental health and ani- mal health workforces,
p.001621: as applicable), describing the status of such workforce, identifying strategies to recruit, retain, and
p.001621: protect such workforce from workplace exposures during public health emergencies, and identifying current
p.001621: capabilities to meet the requirements of section 2803.
p.001621: (b) PREPAREDNESS GOALS.—The National Health Security Strategy shall include provisions in furtherance of the
p.001621: following:
p.001621: (1) INTEGRATION.—Integrating public health and public and private medical capabilities with other first
p.001621: responder sys- tems, including through—
p.001621: (A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities
p.001621: through drills and exercises, including drills and exercises to en- sure medical surge capacity for events
p.001621: without notice; and
p.001621: (B) integrating public and private sector public health and medical donations and volunteers.
p.001621: (2) PUBLIC HEALTH.—Developing and sustaining Federal, State, local, and tribal essential public health security
p.001621: capabili- ties, including the following:
p.001621: (A) Disease situational awareness domestically and abroad, including detection, identification, investigation,
p.001621: and related information technology activities.
p.001621: (B) Disease containment including capabilities for iso- lation, quarantine, social distancing,
p.001621: decontamination, rel- evant health care services and supplies, and transpor- tation and disposal of medical
p.001621: waste.
p.001621: (C) Risk communication and public preparedness.
p.001621: (D) Rapid distribution and administration of medical countermeasures.
p.001621: (E) Response to environmental hazards.
p.001621: (3) MEDICAL.—Increasing the preparedness, response capa- bilities, and surge capacity of hospitals, other health care
p.001621: facili- ties (including pharmacies, mental health facilities, and ambu- latory care facilities and which may
p.001621: include dental health fa- cilities), and trauma care, critical care, and emergency medical service systems, with
p.001621: respect to public health emergencies (in- cluding related availability, accessibility, and coordination),
p.001621: which shall include developing plans for the following:
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001621:
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p.001643: veterinary services, and other services that are determined by the Secretary to be appro- priate with
p.001643: respect to the needs referred to in subsection (a)(3)(A).
p.001643: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing for the Assistant Secretary for
p.001643: Preparedness and Re- sponse and the operations of the National Disaster Medical Sys- tem, other than
p.001643: purposes for which amounts in the Public Health Emergency Fund under section 319 are available, there are
p.001643: author- ized to be appropriated $57,400,000 for each of fiscal years 2019 through 2023.
p.001643: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001643:
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p.001643: Sec. 2813 PUBLIC HEALTH SERVICE ACT 1644
p.001643:
p.001643: SEC. 2813. ø42 U.S.C. 300hh–15¿ VOLUNTEER MEDICAL RESERVE CORPS.
p.001643: (a) IN GENERAL.—Not later than 180 days after the date of en- actment of the Pandemic and All-Hazards
p.001643: Preparedness Act, the Secretary, in collaboration with State, local, and tribal officials, shall build on
p.001643: State, local, and tribal programs in existence on the date of enactment of such Act to establish and maintain a Medical
p.001643: Reserve Corps (referred to in this section as the ‘‘Corps’’) to provide for an adequate supply of volunteers in the
p.001643: case of a Federal, State, local, or tribal public health emergency. The Secretary may appoint a Director to head the
p.001643: Corps and oversee the activities of the Corps chapters that exist at the State, local, Tribal, and territorial levels.
p.001643: (b) STATE, LOCAL, AND TRIBAL COORDINATION.—The Corps shall be established using existing State,
p.001643: local, and tribal teams and shall not alter such teams.
p.001643: (c) COMPOSITION.—The Corps shall be composed of individuals who—
p.001643:
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p.001643: January 30, 2020
p.001643: (1)(A) are health professionals who have appropriate pro- fessional training and expertise as determined
p.001643: appropriate by the Director of the Corps; or
p.001643: (B) are non-health professionals who have an interest in serving in an auxiliary or support capacity to
p.001643: facilitate access to health care services in a public health emergency;
p.001643: (2) are certified in accordance with the certification pro- gram developed under subsection (d);
p.001643: (3) are geographically diverse in residence;
p.001643: (4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
p.001643: (5) indicate whether they are willing to be deployed out- side the area in which they reside in the
p.001643: event of a public health emergency.
p.001643: (d) CERTIFICATION; DRILLS.—
p.001643: (1) CERTIFICATION.—The Director, in collaboration with State, local, and tribal officials, shall establish a
p.001643: process for the periodic certification of individuals who volunteer for the Corps, as determined by the
p.001643: Secretary, which shall include the completion by each individual of the core training programs de- veloped under
p.001643: section 319F, as required by the Director. Such certification shall not supercede State
p.001643: licensing or credentialing requirements.
p.001643: (2) DRILLS.—In conjunction with the core training pro- grams referred to in paragraph (1), and in order
p.001643: to facilitate the integration of trained volunteers into the health care sys- tem at the local level, Corps
p.001643: members shall engage in periodic training exercises to be carried out at the local level. Such training
p.001643: exercises shall, as appropriate and applicable, incor- porate the needs of at-risk individuals in the event of a
p.001643: public health emergency.
p.001643: (e) DEPLOYMENT.—During a public health emergency, the Sec- retary shall have the authority to activate and
p.001643: deploy willing mem- bers of the Corps to areas of need, taking into consideration the public health and
p.001643: medical expertise required, with the concurrence of the State, local, or tribal officials from the area where the mem-
p.001643: bers reside.
p.001643: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001643:
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p.001645: 1645
p.001645: PUBLIC HEALTH SERVICE ACT
p.001645: Sec. 2814
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p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
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p.001645: January 30, 2020
p.001645: 2 So in law. Probably should read ‘‘the Administrator’’.
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645:
p.001647: 1647
p.001647: PUBLIC HEALTH SERVICE ACT
p.001647: Sec. 2822
p.001647:
p.001647: Subtitle C—Strengthening Public Health Surveillance Systems
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p.001647: January 30, 2020
p.001647: SEC. 2821. ø42 U.S.C. 300hh–31¿ EPIDEMIOLOGY-LABORATORY CAPAC- ITY GRANTS.
p.001647: (a) IN GENERAL.—Subject to the availability of appropriations, the Secretary, acting through the Director
p.001647: of the Centers for Dis- ease Control and Prevention, shall establish an Epidemiology and Laboratory
p.001647: Capacity Grant Program to award grants to State health departments as well as local health departments
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p.001649: programs within the Department of Health and Human Services to ensure coordination of respite care
p.001649: services for family caregivers of children and adults with special needs.
p.001649: (d) APPLICATION.—
p.001649: (1) SUBMISSION.—Each Governor desiring the eligible State agency of his or her State to receive a grant or
p.001649: cooperative agreement under this section shall submit an application on behalf of such agency to the
p.001649: Secretary at such time, in such manner, and containing such information as the Secretary shall require.
p.001649: (2) CONTENTS.—Each application submitted under this sec- tion shall include—
p.001649: (A) a description of the eligible State agency’s—
p.001649: (i) ability to work with other State and commu- nity-based agencies;
p.001649: (ii) understanding of respite care and family care- giver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) capacity to ensure meaningful involvement of family members, family caregivers, and care recipi-
p.001649: ents;
p.001649: (B) with respect to the population of family caregivers to whom respite care information or services will be
p.001649: pro- vided or for whom respite care workers and volunteers will be recruited and trained, a description of—
p.001649: (i) the population of family caregivers;
p.001649: (ii) the extent and nature of the respite care needs of that population;
p.001649: (iii) existing respite care services for that popu- lation, including numbers of family caregivers being
p.001649: served and extent of unmet need;
p.001649: (iv) existing methods or systems to coordinate res- pite care information and services to the population at the State
p.001649: and local level and extent of unmet need;
p.001649: (v) how respite care information dissemination and coordination, respite care services, respite care
p.001649: worker and volunteer recruitment and training pro- grams, or training programs for family caregivers that assist
p.001649: such family caregivers in making informed deci- sions about respite care services will be provided using grant or
p.001649: cooperative agreement funds;
p.001649: (vi) a plan for administration, collaboration, and coordination of the proposed respite care
p.001649: activities with other related services or programs offered by public or private, nonprofit entities,
p.001649: including area agencies on aging;
p.001649: (vii) how the population, including family care- givers, care recipients, and relevant public or private
p.001649: agencies, will participate in the planning and imple- mentation of the proposed respite care activities;
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001649:
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p.001649:
p.001651: 1651
p.001651: PUBLIC HEALTH SERVICE ACT
p.001651: Sec. 2902
p.001651:
p.001651: (viii) how the proposed respite care activities will make use, to the maximum extent feasible, of other
p.001651: Federal, State, and local funds, programs, contribu- tions, other forms of reimbursements, personnel, and
p.001651: facilities;
p.001651: (ix) respite care services available to family care- givers in the eligible State agency’s State or
p.001651: locality, including unmet needs and how the eligible State agency’s plan for use of funds will improve
p.001651: the coordi- nation and distribution of respite care services for family caregivers of children and adults
p.001651: with special needs;
p.001651: (x) the criteria used to identify family caregivers eligible for respite care services;
p.001651: (xi) how the quality and safety of any respite care services provided will be monitored, including methods to ensure
p.001651: that respite care workers and volunteers are appropriately screened and possess the necessary skills to care
p.001651: for the needs of the care recipient in the absence of the family caregiver; and
p.001651: (xii) the results expected from proposed respite care activities and the procedures to be used for evalu- ating
p.001651: those results;
p.001651: (C) assurances that, where appropriate, the eligible State agency will have a system for maintaining the
p.001651: con- fidentiality of care recipient and family caregiver records; and
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p.001651: January 30, 2020
p.001651: (D) a memorandum of agreement regarding the joint responsibility for the eligible State agency’s lifespan
p.001651: res- pite program between—
p.001651: (i) the eligible State agency; and
p.001651: (ii) a public or private nonprofit statewide respite coalition or organization.
p.001651: (e) PRIORITY; CONSIDERATIONS.—When awarding grants or co- operative agreements under this section, the Secretary
p.001651: shall—
p.001651: (1) give priority to eligible State agencies that the Sec- retary determines show the greatest
p.001651: likelihood of imple- menting or enhancing lifespan respite care statewide; and
p.001651: (2) give consideration to eligible State agencies that are building or enhancing the capacity of their
p.001651: long-term care sys- tems to respond to the comprehensive needs, including respite care needs, of their residents.
p.001651: (f) USE OF GRANT OR COOPERATIVE AGREEMENT FUNDS.—
p.001651: (1) IN GENERAL.—
p.001651: (A) REQUIRED USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section shall use all or part of the funds—
p.001651: (i) to develop or enhance lifespan respite care at the State and local levels;
p.001651: (ii) to provide respite care services for family care- givers caring for children or adults;
p.001651: (iii) to train and recruit respite care workers and volunteers;
p.001651: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001651:
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p.001651:
p.001651: Sec. 2903 PUBLIC HEALTH SERVICE ACT 1652
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p.001651: January 30, 2020
p.001651:
p.001651: (iv) to provide information to caregivers about available respite and support services; and
p.001651: (v) to assist caregivers in gaining access to such services.
p.001651: (B) OPTIONAL USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section may use part of the funds for—
p.001651: (i) training programs for family caregivers to as- sist such family caregivers in making informed deci-
p.001651: sions about respite care services;
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p.001659: information on whether the technologies and practices developed by such systems may be applicable to and usa-
p.001659: ble in whole or in part by other health care providers.
p.001659: (C) ASSESSMENT OF IMPACT OF HIT ON COMMUNITIES WITH HEALTH DISPARITIES AND UNINSURED, UNDERINSURED,
p.001659: AND MEDICALLY UNDERSERVED AREAS.—The National Coor- dinator shall assess and publish the impact of health infor-
p.001659: mation technology in communities with health disparities and in areas with a high proportion of individuals who
p.001659: are uninsured, underinsured, and medically underserved indi- viduals (including urban and rural areas) and
p.001659: identify practices to increase the adoption of such technology by health care providers in such communities,
p.001659: and the use of health information technology to reduce and better man- age chronic diseases.
p.001659: (D) EVALUATION OF BENEFITS AND COSTS OF THE ELEC- TRONIC USE AND EXCHANGE OF HEALTH INFORMATION.—The
p.001659: National Coordinator shall evaluate and publish evidence on the benefits and costs of the electronic use
p.001659: and ex- change of health information and assess to whom these benefits and costs accrue.
p.001659: (E) RESOURCE REQUIREMENTS.—The National Coordi- nator shall estimate and publish resources required annu- ally to
p.001659: reach the goal of utilization of an electronic health record for each person in the United States by 2014,
p.001659: in- cluding—
p.001659: (i) the required level of Federal funding;
p.001659: (ii) expectations for regional, State, and private in- vestment;
p.001659: (iii) the expected contributions by volunteers to ac- tivities for the utilization of such records; and
p.001659: (iv) the resources needed to establish a health in- formation technology workforce sufficient to support this
p.001659: effort (including education programs in medical informatics and health information management).
p.001659: (7) ASSISTANCE.—The National Coordinator may provide fi- nancial assistance to consumer advocacy groups and
p.001659: not-for- profit entities that work in the public interest for purposes of defraying the cost to such
p.001659: groups and entities to participate under, whether in whole or in part, the National Technology Transfer
p.001659: Act of 1995 (15 U.S.C. 272 note).
p.001659: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001659:
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p.001659:
p.001661: 1661
p.001661: PUBLIC HEALTH SERVICE ACT
p.001661: Sec. 3001
p.001661:
p.001661: (8) GOVERNANCE FOR NATIONWIDE HEALTH INFORMATION NETWORK.—The National Coordinator shall establish a govern-
p.001661: ance mechanism for the nationwide health information net- work.
p.001661: (9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.—
p.001661: (A) IN GENERAL.—The National Coordinator shall, in collaboration with the National Institute of Standards and
p.001661: Technology and other relevant agencies within the Depart- ment of Health and Human Services, for the purpose of en-
p.001661: suring full network-to-network exchange of health infor- mation, convene public-private and public-public
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Health / Mentally Disabled

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p.000349: January 30, 2020
p.000349: HOME HEALTH SERVICES
p.000349: SEC. 339. ø255¿ (a)(1) For the purpose of encouraging the es- tablishment and initial operation of home
p.000349: health programs to pro- vide home health services in areas in which such services are inad- equate or not readily
p.000349: accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and non-
p.000349: profit private entities and loans to proprietary entities to meet the initial costs of establishing and operating
p.000349: such home health pro- grams. Such grants and loans may include funds to provide train- ing for
p.000349: paraprofessionals (including homemaker home health aides) to provide home health services.
p.000349: (2) In making grants and loans under this subsection, the Sec- retary shall—
p.000349: (A) consider the relative needs of the several States for home health services;
p.000349: (B) give preference to areas in which a high percentage of the population proposed to be served is composed of
p.000349: individuals who are elderly, medically indigent, or disabled; and
p.000349: (C) give special consideration to areas with inadequate means of transportation to obtain necessary health
p.000349: services. (3)(A) No loan may be made to a proprietary entity under this
p.000349: section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that—
p.000349: (i) at the time the application is made the entity is fiscally sound;
p.000349: (ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal
p.000349: lenders at the rate of interest prevailing in the area in which the entity is located; and
p.000349: (iii) during the period of the loan, such entity will remain fiscally sound.
p.000349: (B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on
p.000349: the date the loan is made with respect to the marketable obligations of the United States of comparable
p.000349: maturities, adjusted to provide for adminis- trative costs.
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000349:
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p.000349:
p.000349: Sec. 339 PUBLIC HEALTH SERVICE ACT 350
p.000349:
p.000349: (4) Applications for grants and loans under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and loans under this subsection $5,000,000 for
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p.000957: representatives of consumers familiar with the need for the services provided by such facilities, to
p.000957: consult with the State agency in carrying out the plan, and provide, if such council does not include any
p.000957: representatives of nongovernmental orga- nizations or groups, or State agencies, concerned with rehabili- tation, for
p.000957: consultation with organizations, groups, and State agencies so concerned;
p.000957: (4) set forth, in accordance with criteria established in reg- ulations prescribed under section 603 and on the
p.000957: basis of a statewide inventory of existing facilities, a survey of need, and (except to the extent provided by
p.000957: or pursuant to such regula- tions) community, area, or regional plans—
p.000957: (A) the number of general hospital beds and long-term care beds, and the number and types of hospital
p.000957: facilities and facilities for long-term care, needed to provide ade- quate facilities for inpatient care
p.000957: of people residing in the State, and a plan for the distribution of such beds and fa- cilities in service areas
p.000957: throughout the State;
p.000957: (B) the public health centers needed to provide ade- quate public health services for people residing in
p.000957: the State, and a plan for the distribution of such centers throughout the State;
p.000957: (C) the outpatient facilities needed to provide ade- quate diagnostic or treatment services to ambulatory
p.000957: pa- tients residing in the State, and a plan for distribution of such facilities throughout the State;
p.000957: (D) the rehabilitation facilities needed to assure ade- quate rehabilitation services for disabled persons
p.000957: residing in the State, and a plan for distribution of such facilities throughout the State; and
p.000957: (E) effective January 1, 1966, the extent to which ex- isting facilities referred to in section 601 (a)
p.000957: or (b) in the State are in need of modernization;
p.000957: (5) set forth a construction and modernization program conforming to the provisions set forth pursuant to
p.000957: paragraph
p.000957: (4) and regulations prescribed under section 603 and providing for construction or modernization of the hospital
p.000957: or long-term care facilities, public health centers, outpatient facilities and rehabilitation facilities which
p.000957: are needed, as determined under the provisions so set forth pursuant to paragraph (4);
p.000957: (6) set forth, with respect to each of such types of medical facilities, the relative need, determined in accordance
p.000957: with reg- ulations prescribed under section 603, for projects for facilities of that type, and provide for the
p.000957: construction or modernization, insofar as financial resources available therefor and for main-
p.000957: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000957:
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p.000957: Sec. 604 PUBLIC HEALTH SERVICE ACT 958
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p.000973: (e) The term ‘‘nonprofit’’ as applied to any facility means a fa- cility which is owned and operated by one or
p.000973: more nonprofit cor- porations or associations no part of the net earnings of which in- ures, or may
p.000973: lawfully inure, to the benefit of any private share- holder or individual.
p.000973: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000975: 975
p.000975: PUBLIC HEALTH SERVICE ACT
p.000975: Sec. 645
p.000975:
p.000975: (f) The term ‘‘outpatient facility’’ means a facility (located in or apart from a hospital) for the diagnosis or
p.000975: diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
p.000975: (1) which is operated in connection with a hospital, or
p.000975: (2) in which patient care is under the professional super- vision of persons licensed to practice medicine or
p.000975: surgery in the State, or in the case of dental diagnosis or treatment, under the professional supervision of
p.000975: persons licensed to practice den- tistry in the State; or
p.000975: (3) which offers to patients not requiring hospitalization the services of licensed physicians in various
p.000975: medical special- ties, and which provides to its patients a reasonably full-range of diagnostic and treatment
p.000975: services.
p.000975: (g) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of
p.000975: assisting in the rehabilitation of disabled persons through an integrated program of—
p.000975: (1) medical evaluation and services, and
p.000975: (2) psychological, social, or vocational evaluation and serv- ices,
p.000975: under competent professional supervision, and in the case of which—
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p.000975: January 30, 2020
p.000975: (3) the major portion of the required evaluation and serv- ices is furnished within the facility; and
p.000975: (4) either (A) the facility is operated in connection with a hospital, or (B) all medical and related health
p.000975: services are pre- scribed by, or are under the general direction of, persons li- censed to practice medicine
p.000975: or surgery in the State.
p.000975: (h) The term ‘‘facility for long-term care’’ means a facility (in- cluding an extended care facility)
p.000975: providing in-patient care for con- valescent or chronic disease patients who require skilled nursing care and
p.000975: related medical services—
p.000975: (1) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or tuberculous
p.000975: patients) or is operated in connection with a hospital, or
p.000975: (2) in which such nursing care and medical services are prescribed by, or are performed under the general
p.000975: direction of, persons licensed to practice medicine or surgery in the State.
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p.000993: Gov- ernment Corporation Control Act; and
p.000993: (2) maintain with respect to insurance under this subpart an integral set of accounts.
p.000993: SEC. 712. ø292k¿ PARTICIPATION BY FEDERAL CREDIT UNIONS IN FED- ERAL, STATE, AND PRIVATE STUDENT LOAN INSURANCE
p.000993: PROGRAMS.
p.000993: Notwithstanding any other provision of law, Federal credit unions shall, pursuant to regulations of the
p.000993: Administrator of the National Credit Union Administration, have power to make in- sured loans to eligible
p.000993: students in accordance with the provisions of this subpart relating to Federal insured loans.
p.000993: SEC. 713. ø292l¿ DETERMINATION OF ELIGIBLE STUDENTS.
p.000993: For purposes of determining eligible students under this part, in the case of a public school in a State that
p.000993: offers an accelerated, integrated program of study combining undergraduate premedical education and medical
p.000993: education leading to advanced entry, by con- tractual agreement, into an accredited four-year school of medicine which
p.000993: provides the remaining training leading to a degree of doctor of medicine, whenever in this part a provision
p.000993: refers to a student at a school of medicine, such reference shall include only a student enrolled in any of the last
p.000993: four years of such accelerated, integrated program of study.
p.000993: SEC. 714. ø292m¿ REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR DISABLED BORROWERS.
p.000993: If a borrower who has received a loan dies or becomes perma- nently and totally disabled (as determined in accordance
p.000993: with regu- lations of the Secretary), the Secretary shall discharge the bor- rower’s liability on the loan
p.000993: by repaying the amount owed on the loan from the account established under section 710.
p.000993: SEC. 715. ø292n¿ ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.
p.000993: (a) IN GENERAL.—Notwithstanding any other provision of this subpart, the Secretary is authorized to
p.000993: prescribe such regulations as may be necessary to provide for—
p.000993: (1) a fiscal audit of an eligible institution with regard to any funds obtained from a borrower who
p.000993: has received a loan insured under this subpart;
p.000993: (2) the establishment of reasonable standards of financial responsibility and appropriate institutional
p.000993: capability for the administration by an eligible institution of a program of stu- dent financial aid with
p.000993: respect to funds obtained from a stu- dent who has received a loan insured under this subpart;
p.000993:
p.000993:
p.000993:
p.000993:
p.000993: January 30, 2020
p.000993: 2 So in law. See section 102 of Public Law 102–408 (106 Stat. 1994). Probably should be ‘‘right of redemption’’.
p.000993: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000993:
p.000993:
p.000993:
p.000993:
p.000993:
p.000993:
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p.000993:
p.000993:
p.000993: C:\XML\SSA-MERGED.XML
p.000993:
p.000993: Sec. 719 PUBLIC HEALTH SERVICE ACT 994
p.000993:
p.000993: (3) the limitation, suspension, or termination of the eligi- bility under this subpart of any otherwise
...

p.000997: C:\XML\PHSA.BEL HOUSEP
p.000997:
p.000997:
p.000997: C:\XML\SSA-MERGED.XML
p.000997:
p.000997:
p.000999: 999
p.000999: PUBLIC HEALTH SERVICE ACT
p.000999: Sec. 722
p.000999:
p.000999: (A) not in excess of two years during which a borrower who is a full-time student in such a school leaves the
p.000999: school, with the intent to return to such school as a full- time student, in order to engage in a full-time
p.000999: educational activity which is directly related to the health profession for which the borrower is preparing, as
p.000999: determined by the Secretary; or
p.000999: (B) not in excess of two years during which a borrower who is a graduate of such a school is a participant in a fel-
p.000999: lowship training program or a full-time educational activ- ity which—
p.000999: (i) is directly related to the health profession for which such borrower prepared at such school, as deter-
p.000999: mined by the Secretary; and
p.000999: (ii) may be engaged in by the borrower during such a two-year period which begins within twelve months
p.000999: after the completion of the borrower’s partici- pation in advanced professional training described in
p.000999: paragraph (1)(C) or prior to the completion of such borrower’s participation in such training.
p.000999: (d) CANCELLATION OF LIABILITY.—The liability to repay the un- paid balance of such a loan and accrued
p.000999: interest thereon shall be canceled upon the death of the borrower, or if the Secretary deter- mines that he has
p.000999: become permanently, and totally disabled.
p.000999: (e) RATE OF INTEREST.—Such loans shall bear interest, on the unpaid balance of the loan, computed only for
p.000999: periods for which the loan is repayable, at the rate of 5 percent per year.
p.000999: (f) SECURITY OR ENDORSEMENT.—Loans shall be made under this subpart without security or endorsement,
p.000999: except that if the borrower is a minor and the note or other evidence of obligation ex- ecuted by him would not,
p.000999: under the applicable law, create a bind- ing obligation, either security or endorsement may be required.
p.000999: (g) TRANSFERRING AND ASSIGNING LOANS.—No note or other evidence of a loan made under this subpart may be
p.000999: transferred or assigned by the school making the loan except that, if the bor- rowers transfer to another
p.000999: school participating in the program under this subpart, such note or other evidence of a loan may be
p.000999: transferred to such other school.
p.000999: (h) CHARGE WITH RESPECT TO INSURANCE FOR CERTAIN CAN- CELLATIONS.—Subject to regulations of the Secretary, a
p.000999: school may assess a charge with respect to loans made this 4 subpart to cover the costs of insuring
p.000999: against cancellation of liability under sub- section (d).
p.000999: (i) CHARGE WITH RESPECT TO LATE PAYMENTS.—Subject to reg- ulations of the Secretary, and in accordance with
p.000999: this section, a school shall assess a charge with respect to a loan made under this subpart for failure of the
p.000999: borrower to pay all or any part of an in- stallment when it is due and, in the case of a borrower who is enti- tled to
p.000999: deferment of the loan under subsection (c), for any failure to file timely and satisfactory evidence of such
...

p.001095: of a uni- formed service, or (ii) service as a volunteer under the Peace Corps Act, (B) periods (up to ten
p.001095: years) during which the bor- rower is pursuing a full-time or half-time course of study at a collegiate school of
p.001095: nursing leading to baccalaureate degree in nursing or an equivalent degree, or to graduate degree in nurs- ing, or
p.001095: is otherwise pursuing advanced professional training in nursing (or training to be a nurse anesthetist), and
p.001095: (C) such additional periods under the terms of paragraph (8) of this sub- section;
p.001095: (3) in the case of a student who received such a loan before September 29, 1995, an amount up to 85 per centum
p.001095: of any such loan made before such date (plus interest thereon) shall be canceled for full-time
p.001095: employment as a professional nurse (including teaching in any of the fields of nurse training and service
p.001095: as an administrator, supervisor, or consultant in any of the fields of nursing) in any public or nonprofit private
p.001095: agency, institution, or organization (including neighborhood health cen- ters), at the rate of 15 per centum of the
p.001095: amount of such loan (plus interest) unpaid on the first day of such service for each of the first, second, and
p.001095: third complete year of such service, and 20 per centum of such amount (plus interest) for each com- plete fourth
p.001095: and fifth year of such service;
p.001095: (4) the liability to repay the unpaid balance of such loan and accrued interest thereon shall be canceled
p.001095: upon the death of the borrower, or if the Secretary determines that he has be- come permanently and totally disabled;
p.001095: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001095:
p.001095:
p.001095:
p.001095:
p.001095:
p.001095:
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p.001095:
p.001095:
p.001095: C:\XML\SSA-MERGED.XML
p.001095:
p.001095:
p.001097: 1097
p.001097: PUBLIC HEALTH SERVICE ACT
p.001097: Sec. 836
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097:
p.001097: January 30, 2020
p.001097: (5) such a loan shall bear interest on the unpaid balance of the loan, computed only for periods
p.001097: during which the loan is repayable, at the rate of 5 percent per annum;
p.001097: (6) such a loan shall be made without security or endorse- ment, except that if the borrower is a minor and
p.001097: the note or other evidence of obligation executed by him would not, under the applicable law, create a binding
p.001097: obligation, either security or endorsement may be required;
p.001097: (7) no note or other evidence of any such loan may be transferred or assigned by the school making
...

p.001257: one or more non- profit corporations or associations no part of the net earnings of which inures, or
p.001257: may lawfully inure, to the benefit of any private shareholder or individual.
p.001257: (4) The term ‘‘outpatient medical facility’’ means a medical facility (located in or apart from a hospital) for
p.001257: the diagnosis or diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
p.001257: (A) which is operated in connection with a hospital;
p.001257: (B) in which patient care is under the professional su- pervision of persons licensed to practice medicine or
p.001257: sur- gery in the State, or in the case of dental diagnosis or
p.001257:
p.001257:
p.001257:
p.001257: January 30, 2020
p.001257: 1 So in law. Probably should be ‘‘professional’’.
p.001257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001257:
p.001257:
p.001257:
p.001257:
p.001257:
p.001257:
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p.001257:
p.001257:
p.001257: C:\XML\SSA-MERGED.XML
p.001257:
p.001257:
p.001259: 1259
p.001259: PUBLIC HEALTH SERVICE ACT
p.001259: Sec. 1624
p.001259:
p.001259: treatment, under the professional supervision of persons li- censed to practice dentistry in the State; or
p.001259: (C) which offers to patients not requiring hospitaliza- tion the services of licensed physicians in
p.001259: various medical specialties and which provides to its patients a reasonably full range of diagnostic and treatment
p.001259: services.
p.001259: (5) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of assisting in the
p.001259: rehabili- tation of disabled persons through an integrated program of—
p.001259: (A) medical evaluation and services, and
p.001259: (B) psychological, social, or vocational evaluation and services,
p.001259: under competent professional supervision, and in the case of which the major portion of the required
p.001259: evaluation and serv- ices is furnished within the facility; and either the facility is operated in
p.001259: connection with a hospital, or all medical and re- lated health services are prescribed by, or are
p.001259: under the gen- eral direction of, persons licensed to practice medicine or sur- gery in the State.
p.001259: (6) The term ‘‘facility for long-term care’’ means a facility (including a skilled nursing or
p.001259: intermediate care facility) pro- viding in-patient care for convalescent or chronic disease pa- tients who
p.001259: required skilled nursing or intermediate care and related medical services—
p.001259: (A) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or
p.001259: tuberculosis patients) or is operated in connection with a hospital, or
p.001259: (B) in which such care and medical services are pre- scribed by, or are performed under the general direction
p.001259: of, persons licensed to practice medicine or surgery in the State.
p.001259: (7) The term ‘‘construction’’ means construction of new buildings and initial equipment of such buildings
p.001259: and, in any case in which it will help to provide a service not previously provided in the community,
...

p.001359: death associ- ated with the administration of a vaccine before November 15, 1988, such person may not file a petition
p.001359: under subsection (b) for such injury or death.
p.001359: (7) If in a civil action brought against a vaccine adminis- trator or manufacturer for a vaccine-related
p.001359: injury or death damages are awarded under a judgment of a court or a settle- ment of such action, the person
p.001359: who brought such action may not file a petition under subsection (b) for such injury or death.
p.001359: (8) If on the effective date of this part there was pending an appeal or rehearing with respect to a
p.001359: civil action brought against a vaccine administrator or manufacturer and if the outcome of the last
p.001359: appellate review of such action or the last rehearing of such action is the denial of damages for a vaccine-
p.001359: related injury or death, the person who brought such action may file a petition under subsection (b)
p.001359: for such injury or death.
p.001359: (9) This subsection applies only to a person who has sus- tained a vaccine-related injury or death and
p.001359: who is qualified to file a petition for compensation under the Program.
p.001359: (10) The Clerk of the United States Claims Court is au- thorized to continue to receive, and forward,
p.001359: petitions for com- pensation for a vaccine-related injury or death associated with the administration of a vaccine on
p.001359: or after October 1, 1992.
p.001359: (b) PETITIONERS.—
p.001359: (1)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal
p.001359: represent- ative of such person if such person is a minor or is disabled, or the legal representative of
p.001359: any person who died as the result of the administration of a vaccine set forth in the Vaccine In- jury
p.001359: Table may, if the person meets the requirements of sub- section (c)(1), file a petition for compensation
p.001359: under the Pro- gram.
p.001359: (B) No person may file a petition for a vaccine-related in- jury or death associated with a vaccine
p.001359: administered before the effective date of this part if compensation has been paid under this subtitle for 3500
p.001359: petitions for such injuries or deaths.
p.001359: (2) Only one petition may be filed with respect to each ad- ministration of a vaccine. A covered vaccine administered
p.001359: to a pregnant woman shall constitute more than one administra- tion, one to the mother and one to each child (as
p.001359: such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.
p.001359:
p.001359:
p.001359:
p.001359: January 30, 2020
p.001359: 3 So in law. Probably should be followed by a comma.
p.001359: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001359:
p.001359:
p.001359:
p.001359:
p.001359:
p.001359:
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p.001359:
p.001359:
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p.001359:
p.001359:
p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
...

p.001389: employee.
p.001389: (C) FAILURE TO PAY PREMIUM.—The date on which cov- erage ceases under the plan by reason of a failure to make timely
p.001389: payment of any premium required under the plan with respect to the qualified beneficiary. The payment of
p.001389: any premium (other than any payment referred to in the last sentence of paragraph (3)) shall be
p.001389: considered to be timely if made within 30 days after the date due or within such longer period as applies to or under
p.001389: the plan.
p.001389: (D) GROUP HEALTH PLAN COVERAGE OR MEDICARE ENTITLEMEMT.—The date on which the qualified
p.001389: bene- ficiary first becomes, after the date of the election—
p.001389: (i) covered under any other group health plan (as an employee or otherwise) which does not contain any
p.001389: exclusion or limitation with respect to any preexisting condition of such beneficiary (other than such an ex-
p.001389: clusion or limitation which does not apply to (or is sat- isfied by) such beneficiary by reason of chapter 100 of the
p.001389: Internal Revenue Code of 1986, part 7 of subtitle B of title I of the Employee Retirement Income Secu-
p.001389: rity Act of 1974, or title XXVII of this Act), or
p.001389: (ii) entitled to benefits under title XVIII of the So- cial Security Act.
p.001389: (E) TERMINATION OF EXTENDED COVERAGE FOR DIS- ABILITY.—In the case of a qualified beneficiary who is dis-
p.001389: abled at any time during the first 60 days of continuation coverage under this title, the month that begins more than
p.001389: 30 days after the date of the final determination under title II or XVI of the Social Security Act that the
p.001389: qualified beneficiary is no longer disabled.
p.001389: (3) PREMIUM REQUIREMENTS.—The plan may require pay- ment of a premium for any period of continuation coverage,
p.001389: ex- cept that such premium—
p.001389: (A) shall not exceed 102 percent of the applicable pre- mium for such period, and
p.001389: (B) may, at the election of the payor, be made in monthly installments.
p.001389: In no event may the plan require the payment of any premium before the day which is 45 days after the day on
p.001389: which the qualified beneficiary made the initial election for continuation coverage. In the case of an
p.001389: individual described in the last sen- tence of paragraph (2)(A), any reference in subparagraph (A) of this paragraph
p.001389: to ‘‘102 percent’’ is deemed a reference to ‘‘150
p.001389:
p.001389:
p.001389:
p.001389:
p.001389:
p.001389: January 30, 2020
p.001389: 2 Section 421(a)(1)(A)(ii)(III) of Public Law 104–191 (110 Stat. 2087) provides that the last sen- tence of
p.001389: subparagraph (A) is amended by striking ‘‘with respect to such event,’’. The amendment cannot be executed because
p.001389: the term to be struck does not appear. (Compare ‘‘with respect to such event,’’ and ‘‘with respect to such
p.001389: event’’.)
p.001389: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001389:
p.001389:
p.001389:
p.001389:
p.001389:
p.001389:
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p.001389:
p.001389:
p.001391: 1391
p.001391: PUBLIC HEALTH SERVICE ACT
p.001391: Sec. 2204
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
...

p.001393: (i) an eligible TAA recipient (as defined in para- graph (2) of section 35(c) of the Internal Revenue Code of
p.001393: 1986), and
p.001393: (ii) an eligible alternative TAA recipient (as de- fined in paragraph (3) of such section).
p.001393: (C) TAA-RELATED ELECTION PERIOD.—The term ‘‘TAA- related election period’’ means, with respect to a
p.001393: TAA-re- lated loss of coverage, the 60-day election period under this part which is a direct consequence of such loss.
p.001393: (D) TAA-RELATED LOSS OF COVERAGE.—The term ‘‘TAA-related loss of coverage’’ means, with respect to
p.001393: an individual whose separation from employment gives rise to being an TAA-eligible individual, the loss of
p.001393: health bene- fits coverage associated with such separation.
p.001393: SEC. 2206. ø300bb–6¿ NOTICE REQUIREMENTS.
p.001393: In accordance with regulations prescribed by the Secretary—
p.001393: (1) the group health plan shall provide, at the time of com- mencement of coverage under the plan, written
p.001393: notice to each covered employee and spouse of the employee (if any) of the rights provided under this
p.001393: subsection, 3
p.001393: (2) the employer of an employee under a plan must notify the plan administrator of a qualifying event described in
p.001393: para- graph (1), (2), or (4) of section 2203 within 30 days of the date of the qualifying event,
p.001393: (3) each covered employee or qualified beneficiary is re- sponsible for notifying the plan administrator of the
p.001393: occurrence of any qualifying event described in paragraph (3) or (5) of sec- tion 2203 within 60 days after the date of
p.001393: the qualifying event and each qualified beneficiary who is determined, under title II or XVI of the Social
p.001393: Security Act, to have been disabled at
p.001393:
p.001393:
p.001393:
p.001393: January 30, 2020
p.001393: 3 So in law. Probably should be ‘‘this title’’.
p.001393:
p.001393: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001393:
p.001393:
p.001393:
p.001393:
p.001393:
p.001393:
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p.001393:
p.001393:
p.001393: C:\XML\SSA-MERGED.XML
p.001393:
p.001393: Sec. 2207 PUBLIC HEALTH SERVICE ACT 1394
p.001393:
p.001393: any time during the first 60 days of continuation coverage under this title is responsible for notifying
p.001393: the plan adminis- trator of such determination within 60 days after the date of the determination and
p.001393: for notifying the plan administrator within 30 days after the date of any final determination under such title or
p.001393: titles that the qualified beneficiary is no longer disabled, and
p.001393: (4) the plan administrator shall notify—
p.001393: (A) in the case of a qualifying event described in para- graph (1), (2), or (4) of section 2203, any qualified
p.001393: bene- ficiary with respect to such event, and
p.001393: (B) in the case of a qualifying event described in para- graph (3) or (5) of section 2203 where the covered
p.001393: em- ployee notifies the plan administrator under paragraph (3), any qualified beneficiary with respect to such event,
p.001393: of such beneficiary’s rights under this subsection. 4
p.001393: For purposes of paragraph (4), any notification shall be made with- in 14 days of the date on which the plan
p.001393: administrator is notified under paragraph (2) or (3), whichever is applicable, and any such notification
p.001393: to an individual who is a qualified beneficiary as the spouse of the covered employee shall be treated
p.001393: as notification to all other qualified beneficiaries residing with such spouse at the time such notification
p.001393: is made.
p.001393: SEC. 2207. 5 ø300bb–7¿ ENFORCEMENT.
p.001393: Any individual who is aggrieved by the failure of a State, polit- ical subdivision, or agency or instrumentality
p.001393: thereof, to comply with the requirements of this title may bring an action for appro- priate equitable
p.001393: relief.
p.001393: SEC. 2208. ø300bb–8¿ DEFINITIONS.
p.001393: For purposes of this title—
p.001393: (1) GROUP HEALTH PLAN.—The term ‘‘group health plan’’ has the meaning given such term in 5000(b) 6 of
p.001393: the Internal Revenue Code of 1986. Such term shall not include any plan substantially all of the
p.001393: coverage under which is for qualified long-term care services (as defined in section 7702B(c) of such Code). Such
...

Searching for indicator mentally:

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p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
...

p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
p.000875: (11) conduct services-related assessments, including eval- uations of the organization and financing of care,
p.000875: self-help and consumer-run programs, mental health economics, mental health service systems, rural mental
p.000875: health and tele-mental health, and improve the capacity of State to conduct evalua- tions of publicly
p.000875: funded mental health programs;
p.000875: (12) disseminate mental health information, including evi- dence-based practices, to States, political
p.000875: subdivisions, edu- cational agencies and institutions, treatment and prevention service providers, and the
p.000875: general public, including information concerning the practical application of research supported by the
p.000875: National Institute of Mental Health that is applicable to improving the delivery of services;
p.000875: (13) provide technical assistance to public and private enti- ties that are providers of mental health services;
p.000875: (14) monitor and enforce obligations incurred by commu- nity mental health centers pursuant to the Community
p.000875: Mental Health Centers Act (as in effect prior to the repeal of such Act on August 13, 1981, by section
p.000875: 902(e)(2)(B) of Public Law 97– 35 (95 Stat. 560));
p.000875: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000875:
p.000875:
p.000875:
p.000875:
p.000875:
p.000875:
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p.000901: (9) referrals for primary health services, job training, edu- cational services, and relevant housing services;
p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
p.000901:
p.000901:
p.000901:
p.000901:
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p.000901: January 30, 2020
p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
p.000901:
p.000901:
p.000901:
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p.000901:
p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
...

p.000941: vices, surgical dressings or bandages, protective helmets, or any other methods that involves the physical
p.000941: holding of a resident for the purpose of conducting routine physical examinations or tests or to protect
p.000941: the resident from fall- ing out of bed or to permit the resident to participate in activities without the
p.000941: risk of physical harm to the resident (such term does not include a physical escort); and
p.000941: (B) a drug or medication that is used as a restraint to control behavior or restrict the resident’s freedom of move-
p.000941: ment that is not a standard treatment for the resident’s medical or psychiatric condition.
p.000941: (2) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000941: term does not include a time out.
p.000941: (3) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000941: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000941: (4) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000941: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000941: for the purpose of calming. Time out is not seclusion.
p.000941: SEC. 592. ø290ii–1¿ REPORTING REQUIREMENT.
p.000941: (a) IN GENERAL.—Each facility to which the Protection and Ad- vocacy for Mentally Ill Individuals Act of 1986 20
p.000941: applies shall no- tify the appropriate agency, as determined by the Secretary, of each death that occurs
p.000941: at each such facility while a patient is re- strained or in seclusion, of each death occurring within
p.000941: 24 hours after the patient has been removed from restraints and seclusion,
p.000941:
p.000941:
p.000941:
p.000941:
p.000941: January 30, 2020
p.000941: 20 Probably should be Protection and Advocacy for Individuals with Mental Illness Act. See section 3206(a)
p.000941: of Public Law 106–310 (114 Stat. 1193).
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000941:
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p.000941:
p.000941:
p.000943: 943
p.000943: PUBLIC HEALTH SERVICE ACT
p.000943: Sec. 595
p.000943:
p.000943: or where it is reasonable to assume that a patient’s death is a re- sult of such seclusion or restraint. A notification
p.000943: under this section shall include the name of the resident and shall be provided not later than 7 days
p.000943: after the date of the death of the individual in- volved.
p.000943: (b) FACILITY.—In this section, the term ‘‘facility’’ has the mean- ing given the term ‘‘facilities’’ in section
p.000943: 102(3) of the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10802(3)).
p.000943: SEC. 593. 21 ø290ii–3¿ REGULATIONS AND ENFORCEMENT.
p.000943: (a) TRAINING.—Not later than 1 year after the date of the en- actment of this part, the Secretary,
p.000943: after consultation with appro- priate State and local protection and advocacy organizations, physi- cians,
p.000943: facilities, and other health care professionals and patients, shall promulgate regulations that require
p.000943: facilities to which the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10801 et
p.000943: seq.) applies, to meet the requirements of sub- section (b).
p.000943: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require that—
p.000943: (1) facilities described in subsection (a) ensure that there is an adequate number of qualified professional
p.000943: and supportive staff to evaluate patients, formulate written individualized, comprehensive treatment plans,
p.000943: and to provide active treat- ment measures;
p.000943: (2) appropriate training be provided for the staff of such facilities in the use of restraints and any
p.000943: alternatives to the use of restraints; and
p.000943: (3) such facilities provide complete and accurate notifica- tion of deaths, as required under section 592(a).
p.000943: (c) ENFORCEMENT.—A facility to which this part applies that fails to comply with any requirement of this part,
p.000943: including a fail- ure to provide appropriate training, shall not be eligible for partici- pation in any program
p.000943: supported in whole or in part by funds ap- propriated to any Federal department or agency.
p.000943:
p.000943: PART I—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON- MEDICAL, COMMUNITY-BASED
p.000943: FACILITIES FOR CHILDREN AND YOUTH
p.000943:
p.000943: SEC. 595. ø290jj¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN NON-MEDICAL,
p.000943: COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH.
...

p.000975: medical special- ties, and which provides to its patients a reasonably full-range of diagnostic and treatment
p.000975: services.
p.000975: (g) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of
p.000975: assisting in the rehabilitation of disabled persons through an integrated program of—
p.000975: (1) medical evaluation and services, and
p.000975: (2) psychological, social, or vocational evaluation and serv- ices,
p.000975: under competent professional supervision, and in the case of which—
p.000975:
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p.000975: (3) the major portion of the required evaluation and serv- ices is furnished within the facility; and
p.000975: (4) either (A) the facility is operated in connection with a hospital, or (B) all medical and related health
p.000975: services are pre- scribed by, or are under the general direction of, persons li- censed to practice medicine
p.000975: or surgery in the State.
p.000975: (h) The term ‘‘facility for long-term care’’ means a facility (in- cluding an extended care facility)
p.000975: providing in-patient care for con- valescent or chronic disease patients who require skilled nursing care and
p.000975: related medical services—
p.000975: (1) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or tuberculous
p.000975: patients) or is operated in connection with a hospital, or
p.000975: (2) in which such nursing care and medical services are prescribed by, or are performed under the general
p.000975: direction of, persons licensed to practice medicine or surgery in the State.
p.000975: (i) The term ‘‘construction’’ includes construction of new build- ings, expansion, remodeling, and alteration of
p.000975: existing buildings, and initial equipment of any such buildings (including medical transportation facilities)
p.000975: and, in any case in which it will help to provide a service not previously provided in the community, equip-
p.000975: ment of any buildings; including architects’ fees, but excluding the cost of off-site improvements and, except
p.000975: with respect to public health centers, the cost of the acquisition of land.
p.000975: (j) The term ‘‘cost’’ as applied to construction or modernization means the amount found by the Surgeon General
p.000975: to be necessary for construction and modernization respectively, under a project, except that such term, as
p.000975: applied to a project for modernization of a facility for which a grant or loan is to be made from an allotment under
p.000975: section 602(a)(2), does not include any amount found by the Surgeon General to be attributable to expansion of the bed
p.000975: capacity of such facility.
p.000975: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000975:
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p.001257:
p.001257:
p.001259: 1259
p.001259: PUBLIC HEALTH SERVICE ACT
p.001259: Sec. 1624
p.001259:
p.001259: treatment, under the professional supervision of persons li- censed to practice dentistry in the State; or
p.001259: (C) which offers to patients not requiring hospitaliza- tion the services of licensed physicians in
p.001259: various medical specialties and which provides to its patients a reasonably full range of diagnostic and treatment
p.001259: services.
p.001259: (5) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of assisting in the
p.001259: rehabili- tation of disabled persons through an integrated program of—
p.001259: (A) medical evaluation and services, and
p.001259: (B) psychological, social, or vocational evaluation and services,
p.001259: under competent professional supervision, and in the case of which the major portion of the required
p.001259: evaluation and serv- ices is furnished within the facility; and either the facility is operated in
p.001259: connection with a hospital, or all medical and re- lated health services are prescribed by, or are
p.001259: under the gen- eral direction of, persons licensed to practice medicine or sur- gery in the State.
p.001259: (6) The term ‘‘facility for long-term care’’ means a facility (including a skilled nursing or
p.001259: intermediate care facility) pro- viding in-patient care for convalescent or chronic disease pa- tients who
p.001259: required skilled nursing or intermediate care and related medical services—
p.001259: (A) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or
p.001259: tuberculosis patients) or is operated in connection with a hospital, or
p.001259: (B) in which such care and medical services are pre- scribed by, or are performed under the general direction
p.001259: of, persons licensed to practice medicine or surgery in the State.
p.001259: (7) The term ‘‘construction’’ means construction of new buildings and initial equipment of such buildings
p.001259: and, in any case in which it will help to provide a service not previously provided in the community,
p.001259: equipment of any buildings; in- cluding architects’ fees, but excluding the cost of off-site im-
p.001259: provements and, except with respect to public health centers, the cost of the acquisition of land
p.001259: (8) The term ‘‘cost’’ as applied to construction moderniza- tion, or conversion means the amount found
p.001259: by the Secretary to be necessary for construction, modernization, or conversion, respectively, under a
p.001259: project, except that, in the case of a mod- ernization project or a project assisted under part D, such term does not
p.001259: include any amount found by the Secretary to be at- tributable to expansion of the bed capacity of any
p.001259: facility.
p.001259: (9) The term ‘‘modernization’’ includes the alteration, ex- pansion, major repair (to the extent permitted by
p.001259: regulations), remodeling, replacement, and renovation of existing buildings (including initial equipment
p.001259: thereof), and the replacement of obsolete equipment of existing buildings.
p.001259:
p.001259: January 30, 2020 As Amended Through P.L. 116-94,
p.001259: Enacted December 20, 2019
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p.000001: respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State,
p.000001: and local levels:
p.000001: (A) Active duty Regular Corps.
p.000001: (B) Active Reserves.
p.000001: (2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary shall annually determine whether each member of the
p.000001: Corps meets the applicable readiness requirements established under paragraph (1).
p.000001: (3) FAILURE TO MEET REQUIREMENTS.—A member of the Corps who fails to meet or maintain the readiness
p.000001: require- ments established under paragraph (1) or who fails to comply with orders to respond to an urgent or
p.000001: emergency public health care need shall, except as provided in paragraph (4), in accord- ance with procedures
p.000001: established by the Secretary, be subject to disciplinary action as prescribed by the Secretary.
p.000001: (4) WAIVER OF REQUIREMENTS.—
p.000001: (A) IN GENERAL.—The Secretary may waive one or more of the requirements established under paragraph (1)
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
p.000001: 5 PUBLIC HEALTH SERVICE ACT Sec. 203A
p.000001:
p.000001: for an individual who is not able to meet such require- ments because of—
p.000001: (i) a disability;
p.000001: (ii) a temporary medical condition; or
p.000001: (iii) any other extraordinary limitation as deter- mined by the Secretary.
p.000001: (B) REGULATIONS.—The Secretary shall promulgate regulations under which a waiver described in subpara-
p.000001: graph (A) may be granted.
p.000001: (5) URGENT OR EMERGENCY PUBLIC HEALTH CARE NEED.— For purposes of this section and section 214, the term
p.000001: ‘‘urgent or emergency public health care need’’ means a health care need, as determined by the Secretary,
p.000001: arising as the result of—
p.000001: (A) a national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et
p.000001: seq.);
p.000001: (B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and
p.000001: Emergency Assistance Act (42 U.S.C. 5121 et seq.);
p.000001: (C) a public health emergency declared by the Sec- retary under section 319 of this Act; or
p.000001: (D) any emergency that, in the judgment of the Sec- retary, is appropriate for the deployment of
p.000001: members of the Corps.
p.000001: (b) CORPS MANAGEMENT FOR DEPLOYMENT.—The Secretary shall—
p.000001: (1) organize members of the Corps into units for rapid de-
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p.000001:
p.000001: Sec. 204 PUBLIC HEALTH SERVICE ACT 6
p.000001: SURGEON GENERAL
p.000001: SEC. 204. ø205¿ The Surgeon General shall be appointed from the Regular Corps for a four-year term by the
p.000001: President by and with the advice and consent of the Senate. The Surgeon General shall be appointed from
p.000001: individuals who (1) are members of the Regular Corps, and (2) have specialized training or significant
p.000001: ex- perience in public health programs. Upon the expiration of such term, the Surgeon General, unless
p.000001: reappointed, shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he
p.000001: not served as Surgeon General.
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p.000001: January 30, 2020
p.000001:
p.000001: DEPUTY SURGEON GENERAL AND ASSISTANT SURGEONS GENERAL
p.000001: SEC. 205. ø206¿ (a) The Surgeon General shall assign one com- missioned officer from the Regular Corps to
p.000001: administer the Office of the Surgeon General, to act as Surgeon General during the ab- sence or disability
p.000001: of the Surgeon General or in the event of a va- cancy in that office, and to perform such other duties as
p.000001: the Sur- geon General may prescribe, and while so assigned he shall have the title of Deputy Surgeon
p.000001: General.
p.000001: (b) The Surgeon General shall assign eight commissioned offi- cers from the Regular Corps to be, respectively,
p.000001: the Director of the National Institutes of Health, the Chief of the Bureau of State Services, the Chief of
p.000001: the Bureau of Medical Services, the Chief Medical Officer of the United States Coast Guard, the Chief Dental
p.000001: Officer of the Service, the Chief Nurse Officer of the Service, the Chief Pharmacist Officer of the Service,
p.000001: and the Chief Sanitary En- gineering Officer of the Service, and while so serving they shall each have the
p.000001: title of Assistant Surgeon General.
p.000001: (c)(1) The Surgeon General, with the approval of the Secretary, is authorized to create special temporary
p.000001: positions in the grade of Assistant Surgeons General when necessary for the proper staffing of the Service. The
p.000001: Surgeon General may assign officers of either the Regular Corps or the Reserve Corps to any such temporary po-
p.000001: sition, and while so serving they shall each have the title of Assist- ant Surgeon General.
p.000001: (2) Except as provided in this paragraph, the number of special temporary positions created by the Surgeon
p.000001: General under para- graph (1) shall not on any day exceed 1 per centum of the highest number, during the ninety
p.000001: days preceding such day, of officers of the Regular Corps on active duty and officers of the Reserve Corps on
p.000001: active duty for more than thirty days. If on any day the number of such special temporary positions exceeds such 1 per
p.000001: centum limi- tations, for a period of not more than one year after such day, the number of such special temporary
p.000001: positions shall be reduced for purposes of complying with such 1 per centum limitation only by the
p.000001: resignation, retirement, death, or transfer to a position of a lower grade, of any officer holding any such
p.000001: temporary position.
p.000001: (d) The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in
p.000001: case of absence or disability, or vacancy in the offices, of both the Surgeon General and the Deputy
p.000001: Surgeon General.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 7 PUBLIC HEALTH SERVICE ACT Sec. 206
p.000001:
p.000001: GRADES, RANKS, AND TITLES OF THE COMMISSIONED CORPS
p.000001: SEC. 206. ø207¿ (a) The Surgeon General during the period of his appointment as such, shall be of the same grade as the
p.000001: Surgeon General of the army; the Deputy Surgeon General and the Chief Medical Officer of the United
p.000001: States Coast Guard, while assigned as such, shall have the grade corresponding with the grade of major
p.000001: general; and the Chief Dental Officer, while assigned as such, shall have the grade as is prescribed by
p.000001: law for the officer of the Dental Corps selected and appointed as Assistant Surgeon General of the Army.
p.000001: During the period of appointment to the posi- tion of Assistant Secretary for Health, a commissioned officer of the
p.000001: Public Health Service shall have the grade corresponding to the grade of General of the Army. Assistant
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p.000001: 15 PUBLIC HEALTH SERVICE ACT Sec. 210
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p.000001: January 30, 2020
p.000001: twice examined for promotion to such grade) be once reexamined for promotion to such grade. If he is thereupon
p.000001: promoted (otherwise than under subsection (e)), the effective date of such promotion shall be one year later
p.000001: than it would have been but for such failure. Upon the effective date of any permanent promotion of such officer to
p.000001: such grade, he shall be considered as having had only the length of service required for such promotion which he
p.000001: previously failed to receive.
p.000001: (g) If, for reasons other than physical disability, an officer of the Regular Corps in the warrant officer
p.000001: (W–1) grade or junior as- sistant grade is found pursuant to subsection (c) not to be qualified for promotion he shall
p.000001: be separated from the Service. If, for reasons other than physical disability, an officer of the Regular Corps
p.000001: in the chief warrant officer (W–2), chief warrant officer (W–3), assist- ant, senior assistant, or full grade,
p.000001: after having been twice exam- ined for promotion (other than promotion to a restricted grade), fails to be
p.000001: promoted—
p.000001: (1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the Service and paid
p.000001: six months’ basic pay and allowances;
p.000001: (2) if in the chief warrant officer (W–3) or senior assistant grade he shall be separated from the Service and
p.000001: paid one year’s basic pay and allowances;
p.000001: (3) if in the full grade he shall be considered as not in line for promotion and shall, at such time thereafter as the
p.000001: Surgeon General may determine, be retired from the Service with re- tired pay (unless he is entitled to
p.000001: a greater amount by reason of another provision of law)—
p.000001: (A) in the case of an officer who first became a mem- ber of a uniformed service before September 8, 1980,
p.000001: at the rate of 21⁄2 percent of the retired pay base determined under section 1406(h) of title 10, United
p.000001: States Code, for each year, not in excess of 30, of his active commissioned service in the Service; or
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p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
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p.000001: for a period of more than 30 days.
p.000001: (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a).
p.000001: (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401.
p.000001: (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan.
p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
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p.000017: (2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’ means an individual—
p.000017: (A) who is a health care worker, law enforcement offi- cer, firefighter, security personnel, emergency medical per-
p.000017: sonnel, other public safety personnel, or support personnel for such occupational specialities;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 261 PUBLIC HEALTH SERVICE ACT 60
p.000017:
p.000017: (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human
p.000017: Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary;
p.000017: (C) who has volunteered and been selected to be a member of a smallpox emergency response plan
p.000017: described in subparagraph (B) prior to the time at which the Sec- retary publicly announces that an
p.000017: active case of smallpox has been identified either within or outside of the United States; and
p.000017: (D) to whom a smallpox vaccine is administered pur- suant to such approved plan during the effective period of
p.000017: the Declaration (including the portion of such period before the enactment of this part).
p.000017: (3) COVERED INJURY.—The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other
p.000017: than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures
p.000017: established under sec- tion 262, to have been sustained by an individual as the direct result of—
p.000017: (A) administration to the individual of a covered coun- termeasure during the effective period of the
p.000017: Declaration; or
p.000017:
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p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: (B) accidental vaccinia inoculation of the individual in circumstances in which—
p.000017: (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after
p.000017: the end of such period;
p.000017: (ii) smallpox vaccine has not been administered to the individual; and
p.000017: (iii) the individual has been in contact with an in- dividual who is (or who was accidentally inoculated by) a
p.000017: covered individual.
p.000017: (4) DECLARATION.—The term ‘‘Declaration’’ means the Dec- laration Regarding Administration of Smallpox
p.000017: Counter- measures issued by the Secretary on January 24, 2003, and published in the Federal Register on
p.000017: January 28, 2003.
p.000017: (5) EFFECTIVE PERIOD OF THE DECLARATION.—The term ‘‘ef- fective period of the Declaration’’ means the
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p.000017: ment to the table takes effect on the date of the promulgation of the final rule that makes the amendment, and applies
p.000017: to all requests for benefits or compensation under this part that are filed on or after such date or are
p.000017: pending as of such date. In addition, the amendment applies retroactively to an individual who was not with
p.000017: respect to the injury involved an eligible in- dividual under the table as in effect before the amendment but who with
p.000017: respect to such injury is an eligible individual under the table as amended. With respect to a request for benefits or
p.000017: compensation under this part by an individual who becomes an eligible individual as described in the preceding
p.000017: sentence, the Secretary may not provide such benefits or compensation un- less the request (or amendment
p.000017: to a request, as applicable) is filed before the expiration of one year after the effective date of the
p.000017: amendment to the table in the case of an individual to whom the vaccine was administered and before
p.000017: the expiration of two years after such effective date in the case of a request based on accidental
p.000017: vaccinia inoculation.
p.000017: SEC. 264. ø239c¿ MEDICAL BENEFITS.
p.000017: (a) IN GENERAL.—Subject to the succeeding provisions of this section, the Secretary shall make payment or
p.000017: reimbursement for medical items and services as reasonable and necessary to treat a covered injury of an
p.000017: eligible individual, including the services, ap- pliances, and supplies prescribed or recommended by a
p.000017: qualified physician, which the Secretary considers likely to cure, give relief, reduce the degree or the
p.000017: period of disability, or aid in lessening the amount of monthly compensation.
p.000017: (b) BENEFITS SECONDARY TO OTHER COVERAGE.—Payment or reimbursement for services or benefits under subsection
p.000017: (a) shall be secondary to any obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insur- ance carrier, or employer) under any other provision of law or con- tractual
p.000017: agreement, to pay for or provide such services or benefits.
p.000017: SEC. 265. ø239d¿ COMPENSATION FOR LOST EMPLOYMENT INCOME.
p.000017: (a) IN GENERAL.—Subject to the succeeding provisions of this section, the Secretary shall provide compensation
p.000017: to an eligible in- dividual for loss of employment income (based on such income at the time of injury)
p.000017: incurred as a result of a covered injury, at the rate specified in subsection (b).
p.000017: (b) AMOUNT OF COMPENSATION.—
p.000017: (1) IN GENERAL.—Compensation under subsection (a) shall be at the rate of 662⁄3 percent of the relevant pay period
p.000017: (week- ly, monthly, or otherwise), except as provided in paragraph (2).
p.000017: (2) AUGMENTED COMPENSATION FOR DEPENDENTS.—If an el- igible individual has one or more dependents, the basic
p.000017: com- pensation for loss of employment income as described in para- graph (1) shall be augmented at the rate of 81⁄3
p.000017: percent.
p.000017: (3) CONSIDERATION OF OTHER PROGRAMS.—
p.000017: (A) IN GENERAL.—The Secretary may consider the pro- visions of sections 8114, 8115, and 8146a of title 5, United States
p.000017: Code, and any implementing regulations, in deter- mining the amount of payment under subsection (a) and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017: pay com- pensation for loss of employment income or to provide dis- ability or retirement benefits.
p.000017: (B) RELATION TO OTHER OBLIGATIONS.—Compensation under subsection (a) shall not be made to an eligible indi- vidual
p.000017: to the extent that the total of amounts paid to the individual under such subsection and under the other
p.000017: obli- gations referred to in subparagraph (A) is an amount that exceeds the rate specified in subsection (b)(1). If
p.000017: under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this
p.000017: paragraph, be deemed to be received over multiple years rather than received in a single year. The
p.000017: Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple
p.000017: years.
p.000017: (2) NO BENEFITS IN CASE OF DEATH.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employ- ment income subsequent to the receipt, by the survivor or sur- vivors of an eligible individual, of
p.000017: benefits under section 266 for death.
p.000017: (3) LIMIT ON TOTAL BENEFITS.—
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B)—
p.000017: (i) total compensation paid to an individual under subsection (a) shall not exceed $50,000 for any year; and
p.000017:
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p.000017: January 30, 2020
p.000017: (ii) the lifetime total of such compensation for the individual may not exceed an amount equal to the amount
p.000017: authorized to be paid under section 266.
p.000017: (B) PERMANENT AND TOTAL DISABILITY.—The limita- tion under subparagraph (A)(ii) does not apply in the case of
p.000017: an eligible individual who is determined to have a cov- ered injury or injuries meeting the definition
p.000017: of disability in section 216(i) of the Social Security Act (42 U.S.C. 416(i)).
p.000017: (4) WAITING PERIOD.—
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 65 PUBLIC HEALTH SERVICE ACT Sec. 266
p.000017:
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B), an eligible individual shall not be provided compensa- tion
p.000017: under this section for the first 5 work days of loss of employment income.
p.000017: (B) EXCEPTION.—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi-
p.000017: vidual is 10 or more work days.
p.000017: (5) TERMINATION OF BENEFITS.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employment income once the eligible individual involves reaches the age of 65.
p.000017: (d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) shall be in addition to
p.000017: any amounts received by an eligible individual under section 264.
p.000017: SEC. 266. ø239e¿ PAYMENT FOR DEATH.
p.000017: (a) DEATH BENEFIT.—
p.000017: (1) IN GENERAL.—The Secretary shall pay, in the case of an eligible individual whose death is determined to have
p.000017: resulted from a covered injury or injuries, a death benefit in the amount determined under
p.000017: paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public
p.000017: Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control
p.000017: and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the
p.000017: case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the
p.000017: survivor in the place of the parent).
p.000017: (2) BENEFIT AMOUNT.—
p.000017: (A) IN GENERAL.—The amount of the death benefit under paragraph (1) in a fiscal year shall equal
p.000017: the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under
p.000017: subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
p.000017: seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but
p.000017: subject to subparagraph (B).
p.000017: (B) REDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT INCOME.—The amount of the benefit as determined under
p.000017: subparagraph (A) shall be reduced by the total amount of any benefits paid under section 265 with
p.000017: respect to lost employment income.
p.000017: (3) LIMITATIONS.—
p.000017: (A) IN GENERAL.—No benefit is payable under para- graph (1) with respect to the death of an eligible individual
p.000017: if—
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p.000017:
p.000017: January 30, 2020
p.000017: (i) a disability benefit is paid with respect to such individual under the Public Safety Officers’ Benefits
p.000017: Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of
p.000017: 1968 (42 U.S.C. 3796 et seq.); or
p.000017: (ii) a death benefit is paid or payable with respect to such individual under the Public Safety Officers’
p.000017: Benefits Program under subpart 1 of part L of title I
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 266 PUBLIC HEALTH SERVICE ACT 66
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p.000017:
p.000017: of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.).
p.000017: (B) EXCEPTION IN THE CASE OF A LIMITATION ON AP- PROPRIATIONS FOR DISABILITY BENEFITS UNDER PSOB.—In
p.000017: the event that disability benefits available to an eligible individual under the Public Safety Officers’
p.000017: Benefits Pro- gram under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets
p.000017: Act of 1968 (42 U.S.C. 3796 et seq.) are reduced because of a limitation on appro- priations, and such reduction
p.000017: would affect the amount that would be payable under subparagraph (A) without regard to this subparagraph,
p.000017: benefits shall be available under paragraph (1) to the extent necessary to ensure that the survivor or
p.000017: survivors of such individual receives a total amount equal to the amount described in paragraph (2).
p.000017: (b) ELECTION IN CASE OF DEPENDENTS.—
p.000017: (1) IN GENERAL.—In the case of an eligible individual whose death is determined to have resulted from a
p.000017: covered in- jury or injuries, if the individual had one or more dependents under the age of 18, the legal
p.000017: guardian of the dependents may, in lieu of the death benefit under subsection (a), elect to re- ceive on
p.000017: behalf of the aggregate of such dependents payments in accordance with this subsection. An election under
p.000017: the pre- ceding sentence is effective in lieu of a request under sub- section (a) by an individual who
p.000017: is not the legal guardian of such dependents.
p.000017: (2) AMOUNT OF PAYMENTS.—Payments under paragraph (1) with respect to an eligible individual described in such
p.000017: para- graph shall be made as if such individual were an eligible indi- vidual to whom compensation would be paid
p.000017: under subsection
p.000017: (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such
p.000017: individual con- sidered to be an eligible individual described in subsection (c)(3)(B) of such section.
p.000017: (3) LIMITATIONS.—
p.000017: (A) AGE OF DEPENDENTS.—No payments may be made under paragraph (1) once the youngest of the dependents involved
p.000017: reaches the age of 18.
p.000017: (B) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (i) IN GENERAL.—Any payment under paragraph
p.000017: (1) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insurance carrier, or em- ployer), under any other law or contractual agreement, to pay
p.000017: compensation for loss of employment income or to provide disability benefits, retirement benefits, life insurance
p.000017: benefits on behalf of dependents under the age of 18, or death benefits.
p.000017: (ii) RELATION TO OTHER OBLIGATIONS.—Payments under paragraph (1) shall not be made to with respect to an eligible
p.000017: individual to the extent that the total of amounts paid with respect to the individual under such paragraph
p.000017: and under the other obligations re- ferred to in clause (i) is an amount that exceeds the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 67 PUBLIC HEALTH SERVICE ACT Sec. 271
p.000017:
p.000017: rate of payment that applies under paragraph (2). If under any such other obligation a lump-sum payment is
p.000017: made, such payment shall, for purposes of this sub- paragraph, be deemed to be received over multiple years
p.000017: rather than received in a single year. The Sec- retary may, in the discretion of the Secretary, deter-
p.000017: mine how to apportion such payment over multiple years.
p.000017: (c) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) or (b) shall be in addition to
p.000017: any amounts re- ceived by an eligible individual under section 264.
p.000017: SEC. 267. ø239f¿ ADMINISTRATION.
p.000017: (a) ADMINISTRATION BY AGREEMENT WITH OTHER AGENCY OR AGENCIES.—The Secretary may administer any or all of
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p.000017: respecting the assessment of health care technology un- dertaken and supported through units of the Department of
p.000017: Health and Human Services. To the maximum extent feasible such coordi- nation shall be carried out through the Agency
p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
p.000017: statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and
p.000017: demonstrations respecting the assessment of health care technology authorized by this Act through the Agency
p.000017: for Health Care Policy and Research and the National Center for Health Sta- tistics.
p.000017:
p.000017: NATIONAL CENTER FOR HEALTH STATISTICS
p.000017: SEC. 306. 3 ø242k¿ (a) There is established in the Department of Health and Human Services the National Center
p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
p.000017: acute and chronic ill- nesses, and infant and maternal morbidity and mortality,
p.000017: (B) the impact of illness and disability of the popu- lation on the economy of the United States and
p.000017: on other aspects of the well-being of its population (or of such groupings),
p.000017: (C) environmental, social, and other health hazards,
p.000017: (D) determinants of health,
p.000017: (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty
p.000017: and type of practice and the supply of services by hospitals, ex- tended care facilities, home health agencies,
p.000017: and other health institutions,
p.000017: (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types
p.000017: of practice of the health professionals providing such serv- ices, and (ii) services of hospitals,
p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
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p.000017: January 30, 2020
p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 306 PUBLIC HEALTH SERVICE ACT 80
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p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
p.000017: necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data
p.000017: on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific
p.000017: Islanders with significant representation in the State or registration area. Each State or registration area shall
p.000017: be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and
p.000017: transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such
p.000017: data.
p.000017: (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general
p.000017: health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to
p.000017: be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and
p.000017: accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations,
p.000017: and the relationship between de- mographic and socioeconomic characteristics and health character- istics.
p.000017: (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use
p.000017: in such activities of statistics collected or compiled by the Center.
p.000017: (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section,
p.000017: the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and
p.000017: Human Services by—
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 4 So in law. Probably should be capitalized.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111: 111
p.000111: PUBLIC HEALTH SERVICE ACT
p.000111: Sec. 317C
p.000111:
p.000111: (C) to provide information and education to the public on the prevention of such defects and disabilities;
p.000111: (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary
p.000111: health conditions among individuals with disabilities; and
p.000111: (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common
p.000111: permanently disabling birth defect.
p.000111: (3) FOLIC ACID.—The Secretary shall carry out section 317J through the Center.
p.000111: (4) CERTAIN PROGRAMS.—
p.000111: (A) TRANSFERS.—All programs and functions described in subparagraph (B) are transferred to the Center, effec-
p.000111: tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health
p.000111: Act of 2000 10.
p.000111: (B) RELEVANT PROGRAMS.—The programs and func- tions described in this subparagraph are all programs and functions
p.000111: that—
p.000111: (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn
p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
p.000111: sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the
p.000111: Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act
p.000111: referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of
p.000111: the amounts, or the avail- ability of the amounts with respect to the purposes for which the amounts may
p.000111: be expended.
p.000111: (b) GRANTS AND CONTRACTS.—
p.000111: (1) IN GENERAL.—In carrying out subsection (a), the Sec- retary may make grants to and enter into contracts
p.000111: with public and nonprofit private entities.
p.000111: (2) SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.—
p.000111: (A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary
p.000111: may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the
p.000111: recipient in car- rying out the purposes for which the award is made and, for such purposes, may detail
p.000111: to the recipient any officer or employee of the Department of Health and Human Services.
p.000111:
p.000111:
p.000111:
p.000111: January 30, 2020
p.000111: 10 Public Law 106–310, enacted October 17, 2000.
...

p.000215: (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a).
p.000215: (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any
p.000215: appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation
p.000215: made available pur- suant to subsection (g)(1).
p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000215:
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p.000217: 217
p.000217: PUBLIC HEALTH SERVICE ACT
p.000217: Sec. 319F–3
p.000217:
p.000217: (1) IN GENERAL.—Subject to the other provisions of this section, a covered person shall be immune from suit and
p.000217: liabil- ity under Federal and State law with respect to all claims for loss caused by, arising out of,
p.000217: relating to, or resulting from the administration to or the use by an individual of a covered countermeasure
p.000217: if a declaration under subsection (b) has been issued with respect to such countermeasure.
p.000217: (2) SCOPE OF CLAIMS FOR LOSS.—
p.000217: (A) LOSS.—For purposes of this section, the term ‘‘loss’’ means any type of loss, including—
p.000217: (i) death;
p.000217: (ii) physical, mental, or emotional injury, illness, disability, or condition;
p.000217: (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need
p.000217: for medical monitoring; and
p.000217: (iv) loss of or damage to property, including busi- ness interruption loss.
p.000217: Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or
p.000217: discovery of the loss described in the clause.
p.000217: (B) SCOPE.—The immunity under paragraph (1) ap- plies to any claim for loss that has a causal
p.000217: relationship with the administration to or use by an individual of a cov- ered countermeasure, including a causal
p.000217: relationship with the design, development, clinical testing or investigation, manufacture, labeling,
p.000217: distribution, formulation, pack- aging, marketing, promotion, sale, purchase, donation, dis- pensing, prescribing,
p.000217: administration, licensing, or use of such countermeasure.
p.000217: (3) CERTAIN CONDITIONS.—Subject to the other provisions of this section, immunity under paragraph (1)
p.000217: with respect to a covered countermeasure applies only if—
p.000217: (A) the countermeasure was administered or used dur- ing the effective period of the declaration that was
p.000217: issued under subsection (b) with respect to the countermeasure;
p.000217: (B) the countermeasure was administered or used for the category or categories of diseases, health conditions,
p.000217: or threats to health specified in the declaration; and
p.000217: (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to
p.000217: the administration or use of the countermeasure, the counter- measure was administered to or used by an
p.000217: individual who—
p.000217:
p.000217:
p.000217:
p.000217:
p.000217:
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p.000225: request) under Rule 37, Federal Rules of Civil Procedure, only if the court finds that the requesting party
p.000225: needs the information sought to prove or defend as to a material issue contested in such action and that the
p.000225: likely benefits of a response to such request equal or exceed the burden or cost for the responding party of
p.000225: providing such response.
p.000225: (7) REDUCTION IN AWARD OF DAMAGES FOR COLLATERAL SOURCE BENEFITS.—
p.000225: (A) IN GENERAL.—In an action under subsection (d), the amount of an award of damages that would otherwise be
p.000225: made to a plaintiff shall be reduced by the amount of collateral source benefits to such plaintiff.
p.000225: (B) PROVIDER OF COLLATERAL SOURCE BENEFITS NOT TO HAVE LIEN OR SUBROGATION.—No provider of collateral
p.000225: source benefits shall recover any amount against the plain- tiff or receive any lien or credit against the
p.000225: plaintiff’s re- covery or be equitably or legally subrogated to the right of the plaintiff in an action under
p.000225: subsection (d).
p.000225: (C) COLLATERAL SOURCE BENEFIT DEFINED.—For pur- poses of this paragraph, the term ‘‘collateral source ben-
p.000225: efit’’ means any amount paid or to be paid in the future to or on behalf of the plaintiff, or any
p.000225: service, product, or other benefit provided or to be provided in the future to or on behalf of the plaintiff, as
p.000225: a result of the injury or wrongful death, pursuant to—
p.000225: (i) any State or Federal health, sickness, income- disability, accident, or workers’ compensation law;
p.000225: (ii) any health, sickness, income-disability, or acci- dent insurance that provides health benefits or in-
p.000225: come-disability coverage;
p.000225: (iii) any contract or agreement of any group, orga- nization, partnership, or corporation to provide, pay for,
p.000225: or reimburse the cost of medical, hospital, dental, or income disability benefits; or
p.000225: (iv) any other publicly or privately funded pro- gram.
p.000225: (8) NONECONOMIC DAMAGES.—In an action under sub- section (d), any noneconomic damages may be awarded only
p.000225: in an amount directly proportional to the percentage of responsi-
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000225: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 226
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p.000225: January 30, 2020
p.000225:
p.000225: bility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term ‘‘noneconomic
p.000225: damages’’ means damages for losses for physical and emotional pain, suffering, inconvenience, physical
p.000225: impairment, mental anguish, disfigure- ment, loss of enjoyment of life, loss of society and companion- ship,
...

p.000229:
p.000229:
p.000229: January 30, 2020
p.000229: ‘‘Covered Countermeasure Process Fund’’ for purposes of providing timely, uniform, and adequate compensation to
p.000229: eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure
p.000229: pursuant to such declaration, which Fund shall consist of such amounts designated as emergency ap-
p.000229: propriations under section 402 of H. Con. Res. 95 of the 109th Con- gress, this emergency designation shall remain
p.000229: in effect through October 1, 2006.
p.000229: (b) PAYMENT OF COMPENSATION.—
p.000229: (1) IN GENERAL.—If the Secretary issues a declaration under 319F–3(b), the Secretary shall, after amounts
p.000229: have by law been provided for the Fund under subsection (a), provide compensation to an eligible
p.000229: individual for a covered injury di- rectly caused by the administration or use of a covered coun-
p.000229: termeasure pursuant to such declaration.
p.000229: (2) ELEMENTS OF COMPENSATION.—The compensation that shall be provided pursuant to paragraph (1) shall
p.000229: have the same elements, and be in the same amount, as is prescribed by sections 264, 265, and 266 in the
p.000229: case of certain individuals injured as a result of administration of certain counter- measures against
p.000229: smallpox, except that section 266(a)(2)(B) shall not apply.
p.000229: (3) RULE OF CONSTRUCTION.—Neither reasonable and nec- essary medical benefits nor lifetime total benefits
p.000229: for lost em- ployment income due to permanent and total disability shall be limited by section 266.
p.000229: (4) DETERMINATION OF ELIGIBILITY AND COMPENSATION.— Except as provided in this section, the procedures
p.000229: for deter- mining, and for reviewing a determination of, whether an indi- vidual is an eligible individual,
p.000229: whether such individual has sustained a covered injury, whether compensation may be available under
p.000229: this section, and the amount of such com- pensation shall be those stated in section 262 (other than
p.000229: in subsection (d)(2) of such section), in regulations issued pursu- ant to that section, and in such additional
p.000229: or alternate regula- tions as the Secretary may promulgate for purposes of this sec- tion. In making determinations
p.000229: under this section, other than those described in paragraph (5)(A) as to the direct causation of a
p.000229: covered injury, the Secretary may only make such deter- mination based on compelling, reliable, valid, medical
p.000229: and sci- entific evidence.
p.000229: (5) COVERED COUNTERMEASURE INJURY TABLE.—
p.000229: (A) IN GENERAL.—The Secretary shall by regulation establish a table identifying covered injuries that
p.000229: shall be presumed to be directly caused by the administration or use of a covered countermeasure and the
p.000229: time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in
p.000229: order for such pre- sumption to apply. The Secretary may only identify such covered injuries, for purpose
p.000229: of inclusion on the table, where the Secretary determines, based on compelling, reli- able, valid, medical and
p.000229: scientific evidence that adminis- tration or use of the covered countermeasure directly caused such
p.000229: covered injury.
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p.000265:
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p.000265: January 30, 2020
p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
p.000265: (B) such services will be continuous for each such re- cipient;
p.000265: (C) the center will provide follow-up services for indi- viduals who are referred by the center for
p.000265: services de- scribed in paragraph (1);
p.000265: (D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health
p.000265: services (including prenatal care) with respect to the pur- pose described in this subsection; and
p.000265: (E) the center will coordinate the provision of services with other maternal and child health providers
p.000265: operating in the catchment area.
p.000265: (g) MIGRATORY AND SEASONAL AGRICULTURAL WORKERS.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of—
p.000265: (A) migratory agricultural workers, seasonal agricul- tural workers, and members of the families of such migra-
p.000265: tory and seasonal agricultural workers who are within a designated catchment area; and
p.000265: (B) individuals who have previously been migratory agricultural workers but who no longer meet the
p.000265: require- ments of subparagraph (A) of paragraph (3) because of age or disability and members of the families of
p.000265: such individ- uals who are within such catchment area.
p.000265: (2) ENVIRONMENTAL CONCERNS.—The Secretary may enter into grants or contracts under this subsection with
p.000265: public and private entities to—
p.000265: (A) assist the States in the implementation and en- forcement of acceptable environmental health
p.000265: standards, including enforcement of standards for sanitation in mi- gratory agricultural worker and
p.000265: seasonal agricultural worker labor camps, and applicable Federal and State pes- ticide control standards; and
p.000265: (B) conduct projects and studies to assist the several States and entities which have received grants or
p.000265: contracts under this section in the assessment of problems related to camp and field sanitation, exposure to unsafe
p.000265: levels of ag- ricultural chemicals including pesticides, and other envi- ronmental health hazards to which
p.000265: migratory agricultural workers and seasonal agricultural workers, and members of their families, are exposed.
p.000265: (3) DEFINITIONS.—For purposes of this subsection:
p.000265: (A) MIGRATORY AGRICULTURAL WORKER.—The term ‘‘migratory agricultural worker’’ means an individual
p.000265: whose principal employment is in agriculture, who has been so employed within the last 24 months, and
p.000265: who es-
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000265:
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p.000265: Sec. 330 PUBLIC HEALTH SERVICE ACT 266
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p.000475: traumatic brain injury.
p.000475: (d) DEFINITION.—For purposes of this section, the term ‘‘trau- matic brain injury’’ means an acquired
p.000475: injury to the brain. Such term does not include brain dysfunction caused by congenital or de- generative disorders,
p.000475: nor birth trauma, but may include brain inju- ries caused by anoxia due to trauma. The Secretary may revise the
p.000475: definition of such term as the Secretary determines necessary, after consultation with States and other
p.000475: appropriate public or nonprofit private entities.
p.000475:
p.000475:
p.000475:
p.000475: January 30, 2020 As Amended Through P.L. 116-94,
p.000475: Enacted December 20, 2019
p.000475:
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p.000475: Sec. 393C PUBLIC HEALTH SERVICE ACT 476
p.000475:
p.000475: NATIONAL PROGRAM FOR TRAUMATIC BRAIN INJURY SURVEILLANCE AND REGISTRIES
p.000475: SEC. 393C. 88 ø280b–1d¿ (a) IN GENERAL.—The Secretary, act- ing through the Director of the Centers for
p.000475: Disease Control and Prevention, may make grants to States or their designees to de- velop or operate the
p.000475: State’s traumatic brain injury surveillance sys- tem or registry to determine the incidence and prevalence of trau-
p.000475: matic brain injury and related disability, to ensure the uniformity of reporting under such system or
p.000475: registry, to link individuals with traumatic brain injury to services and supports, and to link such
p.000475: individuals with academic institutions to conduct applied research that will support the development of such
p.000475: surveillance systems and registries as may be necessary. A surveillance system or registry under this
p.000475: section shall provide for the collection of data con- cerning—
p.000475: (1) demographic information about each traumatic brain injury;
p.000475: (2) information about the circumstances surrounding the injury event associated with each traumatic brain injury;
p.000475: (3) administrative information about the source of the col- lected information, dates of hospitalization and treatment,
p.000475: and the date of injury; and
p.000475: (4) information characterizing the clinical aspects of the traumatic brain injury, including the severity
p.000475: of the injury, outcomes of the injury, the types of treatments received, and the types of services utilized.
p.000475: (b) Not later than 18 months after the date of enactment of the Traumatic Brain Injury Act of 2008, the Secretary,
p.000475: acting through the Director of the Centers for Disease Control and Prevention and the Director of the National
p.000475: Institutes of Health and in consulta- tion with the Secretary of Defense and the Secretary of Veterans
p.000475: Affairs, shall submit to the relevant committees of Congress a re- port that contains the findings
p.000475: derived from an evaluation con- cerning activities and procedures that can be implemented by the Centers
p.000475: for Disease Control and Prevention to improve the collec- tion and dissemination of compatible epidemiological
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p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
p.000493:
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p.000493: January 30, 2020
p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
p.000493: reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106 of Public Law 106–310 (114
p.000493: Stat. 1175) attempts to make various amendments to section 399D, but the amendments cannot be executed because section
p.000493: 399D was redesignated as section 399A by section 502(1) of such Public Law (114 Stat. 1115). (Section 399D
p.000493: now relates to technical assistance in operations of Statewide cancer registries.)
p.000493: Further, section 3106(m) of the Public Law (114 Stat. 1179) attempts to transfer section 399D to title V of this Act as
...

p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
p.000551: (2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ means—
p.000551: (A) a State or a political subdivision of a State;
p.000551: (B) a consortium of 2 or more States or political sub- divisions of States;
p.000551: (C) a territory;
p.000551: (D) a health facility or program operated by or pursu- ant to a contract with or grant from the Indian Health
p.000551: Service; or
p.000551: (E) any other entity with appropriate expertise in pre- natally and postnatally diagnosed conditions (including na-
p.000551: tionally recognized disability groups), as determined by the Secretary.
p.000551: (3) DISTRIBUTION.—In distributing funds under this sub- section, the Secretary shall place an emphasis on funding
p.000551: part- nerships between health care professional groups and dis- ability advocacy organizations.
p.000551:
p.000551:
p.000551:
p.000551: January 30, 2020
p.000551: 107 So in law. Probably should read ‘‘section 2(1)’’.
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: 553
p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
...

p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
p.000577:
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p.000577: January 30, 2020
p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
p.000577: State epidemiological data for children and adults with autism spectrum disorder and other developmental
p.000577: disabilities. An eligible entity shall assist with the development and coordination of State autism
p.000577: spectrum disorder and other developmental disability surveil- lance efforts within a region. In making such
p.000577: awards, the Sec- retary may provide direct technical assistance in lieu of cash.
p.000577: (2) DATA STANDARDS.—In submitting epidemiological data to the Secretary pursuant to paragraph (1), an
p.000577: eligible entity shall report data according to guidelines prescribed by the Di- rector of the Centers for Disease
p.000577: Control and Prevention, after consultation with relevant State, local, and Tribal public health
p.000577: officials, private sector developmental disability re- searchers, and advocates for individuals with autism
p.000577: spectrum disorder and other developmental disabilities.
p.000577: (3) ELIGIBILITY.—To be eligible to receive an award under paragraph (1), an entity shall be a public or
p.000577: nonprofit private entity (including a health department of a State or a political subdivision of a
p.000577: State, a university, any other educational in- stitution, an Indian tribe, or a tribal organization), and submit
p.000577: to the Secretary an application at such time, in such manner, and containing such information as the
p.000577: Secretary may require.
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000577:
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p.000577: Sec. 399AA PUBLIC HEALTH SERVICE ACT 578
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p.000577: January 30, 2020
p.000577:
p.000577: (b) CENTERS OF EXCELLENCE IN AUTISM SPECTRUM DISORDER EPIDEMIOLOGY.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: shall, subject to the availability of appropriations, award grants or cooperative agreements for the
p.000577: establishment or support of re- gional centers of excellence in autism spectrum disorder and other
p.000577: developmental disabilities epidemiology for the purpose of collecting and analyzing information on the
p.000577: number, inci- dence, correlates, and causes of autism spectrum disorder and other developmental disabilities
p.000577: for children and adults.
p.000577: (2) REQUIREMENTS.—To be eligible to receive a grant or co- operative agreement under paragraph (1), an entity shall
p.000577: sub- mit to the Secretary an application containing such agreements and information as the Secretary may require,
p.000577: including an agreement that the center to be established or supported under the grant or cooperative agreement shall
p.000577: operate in accordance with the following:
p.000577: (A) The center will collect, analyze, and report autism spectrum disorder and other developmental disability data
p.000577: according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention,
p.000577: after con- sultation with State, local, and Tribal public health offi- cials, private sector developmental
p.000577: disability researchers, advocates for individuals with autism spectrum disorder, and advocates for
p.000577: individuals with other developmental disabilities.
p.000577: (B) The center will develop or extend an area of spe- cial research expertise (including genetics,
p.000577: epigenetics, and epidemiological research related to environmental expo- sures), immunology, and other
p.000577: relevant research specialty areas.
p.000577: (C) The center will identify eligible cases and controls through its surveillance system and conduct research
p.000577: into factors which may cause or increase the risk of autism spectrum disorder and other developmental
p.000577: disabilities.
p.000577: (c) FEDERAL RESPONSE.—The Secretary shall coordinate the Federal response to requests for assistance from State
p.000577: health, men- tal health, and education department officials regarding potential or alleged autism spectrum
p.000577: disorder or developmental disability clusters.
p.000577: (d) DEFINITIONS.—In this part:
p.000577: (1) INDIAN TRIBE; TRIBAL ORGANIZATION.—The terms ‘‘In- dian tribe’’ and ‘‘tribal organization’’ have the
p.000577: meanings given such terms in section 4 of the Indian Health Care Improve- ment Act.
p.000577: (2) OTHER DEVELOPMENTAL DISABILITIES.—The term ‘‘other developmental disabilities’’ has the meaning given the
p.000577: term ‘‘developmental disability’’ in section 102(8) of the Develop- mental Disabilities Assistance and Bill
p.000577: of Rights Act of 2000 (42 U.S.C. 15002(8)).
p.000577: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000577: Puerto Rico, American Samoa, Guam, the Commonwealth of the
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: 579
p.000579: PUBLIC HEALTH SERVICE ACT
p.000579: Sec. 399BB
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p.000579: January 30, 2020
p.000579: Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.
p.000579: (e) SUNSET.—This section shall not apply after September 30, 2024.
p.000579: SEC. 399BB. ø280i–1¿ AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION.
p.000579: (a) PURPOSE.—It is the purpose of this section—
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p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
p.000579: autism spectrum disorder or other developmental dis- abilities), and evidence-based interventions.
p.000579: (B) REQUIREMENTS OF AGENCY.—In designating the lead agency under subparagraph (A)(i), the Governor
p.000579: shall—
p.000579:
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p.000579: January 30, 2020
p.000579: (i) select an agency that has demonstrated experi- ence and expertise in—
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: 581
p.000581: PUBLIC HEALTH SERVICE ACT
p.000581: Sec. 399BB
p.000581:
p.000581: (I) autism spectrum disorder and other devel- opmental disability issues; and
p.000581: (II) developing, implementing, conducting, and administering programs and delivering edu- cation,
p.000581: information, and referral services (includ- ing technology-based curriculum-development services) to
p.000581: individuals with autism spectrum dis- order and developmental disabilities and their family members,
p.000581: guardians, advocates or author- ized representatives, providers, and other appro- priate individuals locally
p.000581: and across the State; and
p.000581: (ii) consider input from individuals with autism spectrum disorder and developmental disabilities and their
p.000581: family members, guardians, advocates or author- ized representatives, providers, and other appropriate
p.000581: individuals.
p.000581: (C) INFORMATION.—Information under subparagraph (A)(ii) shall be provided through—
p.000581: (i) toll-free telephone numbers;
p.000581: (ii) Internet websites;
p.000581: (iii) mailings; or
p.000581: (iv) such other means as the Governor may re- quire.
p.000581: (d) TOOLS.—
p.000581: (1) IN GENERAL.—To promote the use of valid and reliable screening tools for autism spectrum disorder and other
p.000581: devel- opmental disabilities, the Secretary shall develop a curriculum for continuing education to assist
p.000581: individuals in recognizing the need for valid and reliable screening tools and the use of such tools.
p.000581: (2) COLLECTION, STORAGE, COORDINATION, AND AVAIL- ABILITY.—The Secretary, in collaboration with the
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p.000731: 18 qualified representatives of the public who are not officers or employees of the Federal Government.
p.000731: Of such members, 12 shall be representatives of health and scientific disciplines with respect to medical
p.000731: rehabilitation and 6 shall be individuals representing the interests of individuals undergoing, or in need of,
p.000731: medical reha- bilitation.
p.000731: (B) The following officials shall serve as ex officio members of the Advisory Board:
p.000731: (i) The Director of the Center.
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p.000731: January 30, 2020
p.000731: 34 See footnote for subsection (d)(3)(A).
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p.000733: 733
p.000733: PUBLIC HEALTH SERVICE ACT
p.000733: Sec. 452A
p.000733:
p.000733: (ii) The Director of the Institute.
p.000733: (iii) The Director of the National Institute on Aging.
p.000733: (iv) The Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000733: (v) The Director of the National Institute on Deafness and Other Communication Disorders.
p.000733: (vi) The Director of the National Heart, Lung, and Blood Institute.
p.000733: (vii) The Director of the National Institute of Neurological Disorders and Stroke.
p.000733: (viii) The Director of the National Institute on Disability and Rehabilitation Research.
p.000733: (ix) The Director of the Division of Program Coordination, Planning, and Strategic Initiatives.
p.000733: (x) The Commissioner for Rehabilitation Services Adminis- tration.
p.000733: (xi) The Assistant Secretary of Defense (Health Affairs).
p.000733: (xii) The Chief Medical Director of the Department of Vet- erans Affairs.
p.000733: (4) The members of the Advisory Board shall, from among the members appointed under paragraph (3)(A), designate
p.000733: an indi- vidual to serve as the chair of the Advisory Board.
p.000733: (g)(1) The Secretary and the heads of other Federal agencies shall jointly review the programs carried out (or
p.000733: proposed to be car- ried out) by each such official with respect to medical rehabilitation research and, as
p.000733: appropriate, enter into agreements preventing du- plication among such programs.
p.000733: (2) The Secretary shall, as appropriate, enter into interagency agreements relating to the coordination of
p.000733: medical rehabilitation research conducted by agencies of the National Institutes of Health and other agencies of the
p.000733: Federal Government.
p.000733: (h) For purposes of this section, the term ‘‘medical rehabilita- tion research’’ means the science of
p.000733: mechanisms and interventions that prevent, improve, restore, or replace lost, underdeveloped, or deteriorating
p.000733: function.
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p.000733: RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND INFERTILITY
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p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
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p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: segregated to the extent appropriate in the treatment of the children involved; or
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p.000991: PUBLIC HEALTH SERVICE ACT
p.000991: Sec. 710
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p.000991: January 30, 2020
p.000991: (2) carry out activities designed to reduce loan defaults;
p.000991: (3) respond to special circumstances that may exist in the financial lending environment that may lead to loan
p.000991: defaults;
p.000991: (4) coordinate with other Federal entities that are involved with student loan programs, including—
p.000991: (A) with respect to the Department of Education, in the development of a single student loan application form,
p.000991: a single student loan deferment form, a single disability form, and a central student loan database; and
p.000991: (B) with respect to the Department of Justice, in the recovery of payments from health professionals who
p.000991: have defaulted on loans guaranteed under this subpart; and
p.000991: (5) provide technical assistance to borrowers, lenders, hold- ers, and institutions concerning deferments and
p.000991: collection ac- tivities.
p.000991: (c) ADDITIONAL DUTIES.—In conjunction with the report sub- mitted under subsection (b), the Office shall—
p.000991: (1) compile, and publish in the Federal Register, a list of the borrowers who are in default under this
p.000991: subpart; and
p.000991: (2) send the report and notices of default with respect to these borrowers to relevant Federal agencies
p.000991: and to schools, school associations, professional and specialty associations, State licensing boards,
p.000991: hospitals with which such borrowers may be associated, and any other relevant organizations.
p.000991: (d) ALLOCATION OF FUNDS FOR OFFICE.—In the case of amounts reserved under section 710(a)(2)(B)
p.000991: for obligation under this subsection, the Secretary may obligate the amounts for the purpose of
p.000991: administering the Office, including 7 full-time equiva- lent employment positions for such Office. With
p.000991: respect to such purpose, amounts made available under the preceding sentence are in addition to amounts made
p.000991: available to the Health Resources and Services Administration for program management for the fiscal year
p.000991: involved. With respect to such employment positions, the posi- tions are in addition to the number of full-time
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p.000995: January 30, 2020
p.000995: Secretary for this purpose, or a nonprofit private entity des- ignated by the State, regulated by the State,
p.000995: and approved by the Secretary.
p.000995: (3) The term ‘‘line of credit’’ means an arrangement or agreement between the lender and the borrower
p.000995: whereby a loan is paid out by the lender to the borrower in annual in- stallments, or whereby the
p.000995: lender agrees to make, in addition to the initial loan, additional loans in subsequent years.
p.000995: (4) The term ‘‘school of allied health’’ means a program in a school of allied health (as defined in section 799) which
p.000995: leads to a masters’ degree or a doctoral degree.
p.000995: (5)(A) The term ‘‘default rate’’, in the case of an eligible en- tity, means the percentage constituted by the ratio
p.000995: of—
p.000995: (i) the principal amount of loans insured under this subpart—
p.000995: (I) that are made with respect to the entity and that enter repayment status after April 7, 1987; and
p.000995: (II) for which amounts have been paid under sec- tion 707(a) to insurance beneficiaries, exclusive of any loan
p.000995: for which amounts have been so paid as a result of the death or total and permanent disability of the
p.000995: borrower; exclusive of any loan for which the borrower begins payments to the Secretary on the loan pursu- ant
p.000995: to section 707(b) and maintains payments for 12 consecutive months in accordance with the agreement
p.000995: involved (with the loan subsequently being included or excluded, as the case may be, as amounts paid under
p.000995: section 707(a) according to whether further defaults occur and whether with respect to the default involved
p.000995: compliance with such requirement regarding 12 con- secutive months occurs); and exclusive of any loan on
p.000995: which payments may not be recovered by reason of the obligation under the loan being discharged in bank- ruptcy
p.000995: under title 11, United States Code; to
p.000995: (ii) the total principal amount of loans insured under this subpart that are made with respect to the
p.000995: entity and that enter repayment status after April 7, 1987.
p.000995: (B) For purposes of subparagraph (A), a loan insured under this subpart shall be considered to
p.000995: have entered repay- ment status if the applicable period described in subparagraph
p.000995: (B) of section 705(a)(2) regarding the loan has expired (without regard to whether any period described in subparagraph
p.000995: (C) of such section is applicable regarding the loan).
p.000995: (C) For purposes of subparagraph (A), the term ‘‘eligible entity’’ means an eligible institution, an
p.000995: eligible lender, or a holder, as the case may be.
p.000995: (D) For purposes of subparagraph (A), a loan is made with respect to an eligible entity if—
p.000995: (i) in the case of an eligible institution, the loan was made to students of the institution;
p.000995: (ii) in the case of an eligible lender, the loan was made by the lender; and
...

p.001021: (b) LOAN REPAYMENTS AND FELLOWSHIPS.—For the purpose of carrying out section 738, there is authorized to
p.001021: be appropriated,
p.001021: $5,000,000 for each of the fiscal years 2010 through 2014.
p.001021: (c) EDUCATIONAL ASSISTANCE IN HEALTH PROFESSIONS REGARD- ING INDIVIDUALS FOR DISADVANTAGED BACKGROUNDS.—For
p.001021: the pur- pose of grants and contracts under section 739(a)(1), there is au- thorized to be appropriated
p.001021: $60,000,000 for fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011
p.001021: through 2014. The Secretary may use not to exceed 20 percent of the amount appropriated for a fiscal
p.001021: year under this subsection to provide scholarships under section 739(a)(2)(F).
p.001021: (d) REPORT.—Not later than 6 months after the date of enact- ment of this part, the Secretary shall
p.001021: prepare and submit to the appropriate committees of Congress a report concerning the efforts of the Secretary to
p.001021: address the need for a representative mix of in- dividuals from historically minority health professions schools,
p.001021: or from institutions or other entities that historically or by geographic location have a demonstrated record
p.001021: of training or educating underrepresented minorities, within various health professions dis- ciplines, on peer
p.001021: review councils.
p.001021: SEC. 741. ø293e¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001021: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—
p.001021: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001021: Administra- tion, may make awards of grants, contracts, or cooperative agreements to public and nonprofit
p.001021: private entities (including tribal entities) for the development, evaluation, and dissemina- tion of research,
p.001021: demonstration projects, and model curricula for cultural competency, prevention, public health proficiency,
p.001021: reducing health disparities, and aptitude for working with indi- viduals with disabilities training for use in
p.001021: health professions schools and continuing education programs, and for other pur- poses determined as appropriate by
p.001021: the Secretary.
p.001021: (2) ELIGIBLE ENTITIES.—Unless specifically required other- wise in this title, the Secretary shall accept
p.001021: applications for grants or contracts under this section from health professions schools, academic health
p.001021: centers, State or local governments, or other appropriate public or private nonprofit entities (or con- sortia of
p.001021: entities, including entities promoting multidisciplinary approaches) for funding and participation in health
p.001021: professions training activities. The Secretary may accept applications from
p.001021: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001021:
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p.001021:
p.001021: Sec. 747 PUBLIC HEALTH SERVICE ACT 1022
p.001021:
p.001021: for-profit private entities as determined appropriate by the Secretary.
p.001021: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with health professional
p.001021: societies, licensing and accreditation entities, health professions schools, and experts in minority health and
p.001021: cultural competency, prevention, and public health and disability groups, community-based organizations, and
p.001021: other organizations as determined appropriate by the Secretary. The Secretary shall coordinate with
p.001021: curricula and research and demonstration projects developed under section 807.
p.001021: (c) DISSEMINATION.—
p.001021: (1) IN GENERAL.—Model curricula developed under this section shall be disseminated through the Internet
p.001021: Clearing- house under section 270 and such other means as determined appropriate by the Secretary.
p.001021: (2) EVALUATION.—The Secretary shall evaluate the adop- tion and the implementation of cultural competency,
p.001021: preven- tion, and public health, and working with individuals with a disability training curricula, and
p.001021: the facilitate inclusion of these competency measures in quality measurement systems as appropriate.
p.001021: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.001021: such sums as may be necessary for each of fiscal years 2010 through 2015.
p.001021:
p.001021: PART C—TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL PEDIATRICS, PHYSICIAN
p.001021: ASSISTANTS, GEN- ERAL DENTISTRY, AND PEDIATRIC DEN- TISTRY
p.001021: Subpart I—Medical Training Generally
p.001021:
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p.001021: January 30, 2020
p.001021: SEC. 747. ø293k¿ PRIMARY CARE TRAINING AND ENHANCEMENT.
p.001021: (a) SUPPORT AND DEVELOPMENT OF PRIMARY CARE TRAINING PROGRAMS.—
p.001021: (1) IN GENERAL.—The Secretary may make grants to, or enter into contracts with, an accredited public or
p.001021: nonprofit pri- vate hospital, school of medicine or osteopathic medicine, aca- demically affiliated physician
p.001021: assistant training program, or a public or private nonprofit entity which the Secretary has de- termined
p.001021: is capable of carrying out such grant or contract—
p.001021: (A) to plan, develop, operate, or participate in an ac- credited professional training program, including
p.001021: an ac- credited residency or internship program in the field of family medicine, general internal
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p.001025: (A) is accredited by a nationally recognized accrediting agency or association listed under section 101(c) of
p.001025: the Higher Education Act of 1965 (20 U.S.C. 1001(c)); and
p.001025: (B) has established a public-private educational part- nership with a nursing home or skilled nursing
p.001025: facility, agency or entity providing home and community based services to individuals with disabilities, or
p.001025: other long-term care provider; and
p.001025: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001025: Sec- retary may require.
p.001025: (c) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant under this section
p.001025: to provide assistance to eligible individuals to offset the cost of tuition and required fees for enrollment in
p.001025: academic programs provided by such entity.
p.001025: (d) ELIGIBLE INDIVIDUAL.—
p.001025: (1) ELIGIBILITY.—To be eligible for assistance under this section, an individual shall be enrolled in
p.001025: courses provided by a grantee under this subsection and maintain satisfactory aca- demic progress in such courses.
p.001025: (2) CONDITION OF ASSISTANCE.—As a condition of receiving assistance under this section, an individual shall
p.001025: agree that, following completion of the assistance period, the individual will work in the field of geriatrics,
p.001025: disability services, long term
p.001025: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001025: Sec. 748 PUBLIC HEALTH SERVICE ACT 1026
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p.001025:
p.001025: services and supports, or chronic care management for a min- imum of 2 years under guidelines set by the
p.001025: Secretary.
p.001025: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001025: $10,000,000 for the pe- riod of fiscal years 2011 through 2013.
p.001025: SEC. 748. ø293k–2¿ TRAINING IN GENERAL, PEDIATRIC, AND PUBLIC HEALTH DENTISTRY.
p.001025: (a) SUPPORT AND DEVELOPMENT OF DENTAL TRAINING PRO-
p.001025: GRAMS.—
p.001025: (1) IN GENERAL.—The Secretary may make grants to, or enter into contracts with, a school of dentistry,
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p.001087: (B) the workforce diversity activities under part C;
p.001087: and
p.001087: (C) basic nursing education and practice activities
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p.001087: under part D.
p.001087: (g) STATE AND REGIONAL PRIORITIES.—Activities under grants or contracts under this title shall, to the
p.001087: extent practicable, be con- sistent with related Federal, State, or regional nursing professions program plans and
p.001087: priorities.
p.001087: (h) FILING OF APPLICATIONS.—
p.001087: (1) IN GENERAL.—Applications for grants or contracts under this title may be submitted by
p.001087: health professions schools, schools of nursing, academic health centers, State or local governments, or
p.001087: other appropriate public or private non- profit entities as determined appropriate by the Secretary in
p.001087: accordance with this title.
p.001087: (2) FOR-PROFIT ENTITIES.—Notwithstanding paragraph (1), a for-profit entity may be eligible for a grant or
p.001087: contract under this title as determined appropriate by the Secretary.
p.001087: SEC. 807. ø296e–1¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001087: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—The Secretary,
p.001087: acting through the Administrator of the Health Resources and Services Administration, may make awards of
p.001087: grants, contracts, or coopera- tive agreements to eligible entities for the development, evaluation, and dissemination
p.001087: of research, demonstration projects, and model curricula for cultural competency, prevention, public health
p.001087: pro- ficiency, reducing health disparities, and aptitude for working with individuals with disabilities training
p.001087: for use in health professions schools and continuing education programs, and for other purposes determined as
p.001087: appropriate by the Secretary. Grants under this sec- tion shall be the same as provided in section 741.
p.001087: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with the entities
p.001087: described in section 741(b). The Secretary shall coordinate with curricula and research and demonstration
p.001087: projects developed under such section 741.
p.001087: (c) DISSEMINATION.—Model curricula developed under this sec- tion shall be disseminated and evaluated in the
p.001087: same manner as
p.001087: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001087:
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p.001089: PUBLIC HEALTH SERVICE ACT
p.001089: Sec. 811
p.001089:
p.001089: model curricula developed under section 741, as described in sub- section (c) of such section.
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p.001191: January 30, 2020
p.001191: the purpose of aiding the State in carrying out section 1211(b) and, for such purpose, may detail to the State
p.001191: any officer or employee of the Department of Health and Human Services.
p.001191: (2) REDUCTION IN PAYMENTS.—With respect to a request described in paragraph (1), the Secretary shall
p.001191: reduce the amount of payments to the State under section 1211(a) by an amount equal to the costs of
p.001191: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001191: Secretary. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001191: expend the amounts withheld.
p.001191: SEC. 1222. ø300d–22¿ REPORT BY SECRETARY.
p.001191: Not later than October 1, 2008, the Secretary shall report to the appropriate committees of Congress on
p.001191: the activities of the States carried out pursuant to section 1211. Such report shall in- clude an
p.001191: assessment of the extent to which Federal and State ef- forts to develop systems of trauma care and to
p.001191: designate trauma centers have reduced the incidence of mortality, and the incidence of permanent
p.001191: disability, resulting from trauma. Such report may include any recommendations of the Secretary for
p.001191: appropriate ad- ministrative and legislative initiatives with respect to trauma care.
p.001191: PART C—GENERAL PROVISIONS REGARDING PARTS A AND B
p.001191: SEC. 1231. ø300d–31¿ DEFINITIONS.
p.001191: For purposes of this part and parts A and B:
p.001191: (1) DESIGNATED TRAUMA CENTER.—The term ‘‘designated trauma center’’ means a trauma center designated in
p.001191: accord- ance with the modifications to the State plan described in sec- tion 1213.
p.001191: (2) STATE PLAN REGARDING EMERGENCY MEDICAL SERV- ICES.—The term ‘‘State plan’’, with respect to the
p.001191: provision of emergency medical services, means a plan for a comprehensive, organized system to provide for the
p.001191: access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and
p.001191: rehabilitation of patients of all ages with respect to emergency medical services.
p.001191: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.001191: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
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p.001195: hearings and other types of community outreach programs. In developing recommendations under this paragraph, such
p.001195: boards shall consult with Federal, State, and local governmental agencies and with citizens groups and other
p.001195: private entities.
p.001195: (3) COMPOSITION.—An advisory board established under paragraph (1) shall be composed of—
p.001195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: PUBLIC HEALTH SERVICE ACT
p.001197: Sec. 1252
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p.001197: January 30, 2020
p.001197: (A) representatives of—
p.001197: (i) the corresponding State or American Indian consortium agencies involved;
p.001197: (ii) public and nonprofit private health related or- ganizations;
p.001197: (iii) other disability advisory or planning groups within the State or American Indian consortium;
p.001197: (iv) members of an organization or foundation rep- resenting individuals with traumatic brain injury in that
p.001197: State or American Indian consortium; and
p.001197: (v) injury control programs at the State or local level if such programs exist; and
p.001197: (B) a substantial number of individuals with traumatic brain injury, or the family members of such individuals.
p.001197: (c) MATCHING FUNDS.—
p.001197: (1) IN GENERAL.—With respect to the costs to be incurred by a State or American Indian consortium in
p.001197: carrying out the purpose described in subsection (a), the Secretary may make a grant under such subsection only
p.001197: if the State or American In- dian consortium agrees to make available non-Federal con- tributions toward
p.001197: such costs in an amount that is not less than
p.001197: $1 for each $2 of Federal funds provided under the grant.
p.001197: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001197: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001197: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001197: not be included in determining the amount of such contributions.
p.001197: (d) APPLICATION FOR GRANT.—The Secretary may make a grant under subsection (a) only if an application for the
p.001197: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.001197: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
...

p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
p.001361: (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a
p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
p.001361: (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table—
p.001361: (I) received the vaccine in the United States or in its trust territories,
p.001361: (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person
p.001361: was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the
p.001361: United States or a dependent of such a citizen, or
p.001361: (III) received the vaccine outside the United States or a trust territory and the vaccine was manu-
p.001361: factured by a vaccine manufacturer located in the United States and such person returned to the United States
p.001361: not later than 6 months after the date of the vaccination,
p.001361: (ii) if such person did not receive such a vaccine but contracted polio from another person who received an
p.001361: oral polio vaccine, was a citizen of the United States or a de- pendent of such a citizen,
p.001361: (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the
p.001361: Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the
p.001361: administration of such vaccine, and the first symptom or manifestation of the onset or of the significant
p.001361: aggravation of any such ill- ness, disability, injury, or condition or the death occurred within the
p.001361: time period after vaccine administration set forth in the Vaccine Injury Table, or
p.001361: (ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or condition not set
p.001361: forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
p.001361: (II) sustained, or had significantly aggravated, any ill- ness, disability, injury, or condition set forth in
p.001361: the Vac- cine Injury Table the first symptom or manifestation of the onset or significant aggravation of which
p.001361: did not occur within the time period set forth in the Table but which was caused by a vaccine referred
p.001361: to in subparagraph (A), (D)(i) suffered the residual effects or complications of such illness, disability,
p.001361: injury, or condition for more than
p.001361: 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine,
p.001361: or (iii) suf- fered such illness, disability, injury, or condition from the
p.001361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
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p.001361:
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p.001361:
p.001361: Sec. 2112 PUBLIC HEALTH SERVICE ACT 1362
p.001361:
p.001361: vaccine which resulted in inpatient hospitalization and surgical intervention, and
p.001361: (E) has not previously collected an award or settle- ment of a civil action for damages for such
p.001361: vaccine-related injury or death,
p.001361: (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records
p.001361: (including all physicians’ and nurses’ notes and test results), vaccination records associated with the
p.001361: vaccine allegedly causing the in- jury, pre- and post-injury physician or clinic records (including all relevant
p.001361: growth charts and test results), all post-injury in- patient and outpatient records (including all
p.001361: provider notes, test results, and medication records), if applicable, a death cer- tificate, and if applicable,
p.001361: autopsy results, and
p.001361: (3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the
p.001361: petitioner and the reasons for their unavailability.
p.001361: (d) ADDITIONAL INFORMATION.—A petition may also include other available relevant medical records relating to the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
...

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p.001361:
p.001361:
p.001363: 1363
p.001363: PUBLIC HEALTH SERVICE ACT
p.001363: Sec. 2112
p.001363:
p.001363: spondent, shall participate, and shall be represented in accord- ance with section 518(a) of title 28, United States
p.001363: Code.
p.001363: (2) Within 30 days after the Secretary receives service of any petition filed under section 2111 the
p.001363: Secretary shall pub- lish notice of such petition in the Federal Register. The special master designated with
p.001363: respect to such petition under sub- section (c) shall afford all interested persons an opportunity to submit
p.001363: relevant, written information—
p.001363: (A) relating to the existence of the evidence described in section 2113(a)(1)(B), or
p.001363: (B) relating to any allegation in a petition with respect to the matters described in section 2111(c)(1)(C)(ii).
p.001363: (c) UNITED STATES CLAIMS COURT SPECIAL MASTERS.—
p.001363: (1) There is established within the United States Claims Court an office of special masters which shall
p.001363: consist of not more than 8 special masters. The judges of the United States Claims Court shall appoint the
p.001363: special masters, 1 of whom, by designation of the judges of the United States Claims Court, shall serve as
p.001363: chief special master. The appointment and re- appointment of the special masters shall be by the concurrence of a
p.001363: majority of the judges of the court.
p.001363: (2) The chief special master and other special masters shall be subject to removal by the judges of the United
p.001363: States Claims Court for incompetency, misconduct, or neglect of duty or for physical or mental disability or for
p.001363: other good cause shown.
p.001363: (3) A special master’s office shall be terminated if the judges of the United States Claims Court determine,
p.001363: upon ad- vice of the chief special master, that the services performed by that office are no longer needed.
p.001363: (4) The appointment of any individual as a special master shall be for a term of 4 years, subject to
p.001363: termination under paragraphs (2) and (3). Individuals serving as special masters upon the date of the
p.001363: enactment of this subsection shall serve for 4 years from the date of their original appointment, subject to
p.001363: termination under paragraphs (2) and (3). The chief special master in office on the date of the enactment of this
p.001363: subsection shall continue to serve as chief special master for the balance of the master’s term, subject to
p.001363: termination under paragraphs
p.001363: (2) and (3).
p.001363: (5) The compensation of the special masters shall be deter- mined by the judges of the United States Claims
p.001363: Court, upon advice of the chief special master. The salary of the chief spe- cial master shall be the
p.001363: annual rate of basic pay for level IV of the Executive Schedule, as prescribed by section 5315, title
p.001363: 5, United States Code. The salaries of the other special mas- ters shall not exceed the annual rate of basic
p.001363: pay of level V of the Executive Schedule, as prescribed by section 5316, title 5, United States Code.
p.001363: (6) The chief special master shall be responsible for the fol- lowing:
p.001363:
p.001363:
p.001363:
p.001363:
p.001363: January 30, 2020
p.001363: (A) Administering the office of special masters and their staff, providing for the efficient, expeditious,
...

p.001367: (e)(2)(C)), or
p.001367: (2) the United States Claims Court fails to enter a judg- ment under this section on a petition within 420
p.001367: days (exclud- ing (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D), and (B) any days the
p.001367: petition is before a special mas- ter as a result of a remand under subsection (e)(2)(C)) after the date on which the
p.001367: petition was filed,
p.001367: the special master or court shall notify the petitioner under such petition that the petitioner may
p.001367: withdraw the petition under sec- tion 2121(b) or the petitioner may choose under section 2121(b) to have
p.001367: the petition remain before the special master or court, as the case may be.
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367: January 30, 2020
p.001367:
p.001367: DETERMINATION OF ELIGIBILITY AND COMPENSATION
p.001367: SEC. 2113. ø300aa–13¿ (a) GENERAL RULE.—
p.001367: (1) Compensation shall be awarded under the Program to a petitioner if the special master or court
p.001367: finds on the record as a whole—
p.001367: (A) that the petitioner has demonstrated by a prepon- derance of the evidence the matters required in the
p.001367: peti- tion by section 2111(c)(1), and
p.001367: (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition,
p.001367: or death de- scribed in the petition is due to factors unrelated to the ad- ministration of the vaccine described in
p.001367: the petition.
p.001367: The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by
p.001367: medical records or by medical opinion.
p.001367: (2) For purposes of paragraph (1), the term ‘‘factors unre- lated to the administration of the vaccine’’—
p.001367: (A) does not include any idiopathic, unexplained, un- known, hypothetical, or undocumentable cause, factor,
p.001367: in- jury, illness, or condition, and
p.001367: (B) may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trau-
p.001367: ma (including birth trauma and related anoxia), or meta- bolic disturbances which have no known relation
p.001367: to the vaccine involved, but which in the particular case are shown to have been the agent or agents
p.001367: principally respon- sible for causing the petitioner’s illness, disability, injury, condition, or death.
p.001367: (b) MATTERS TO BE CONSIDERED.—
p.001367: (1) In determining whether to award compensation to a pe- titioner under the Program, the special master or
p.001367: court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
p.001367: (A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained
p.001367: in the record regarding the nature, causation, and aggravation of
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
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p.001367:
p.001367: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1368
p.001367:
p.001367: the petitioner’s illness, disability, injury, condition, or death, and
p.001367: (B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and
p.001367: conclusions.
p.001367: Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the
p.001367: special master or court. In evaluating the weight to be afforded to any such diag- nosis, conclusion, judgment,
p.001367: test result, report, or summary, the special master or court shall consider the entire record and the course of
p.001367: the injury, disability, illness, or condition until the date of the judgment of the special master or court.
p.001367: (2) The special master or court may find the first symptom or manifestation of onset or significant aggravation
p.001367: of an in- jury, disability, illness, condition, or death described in a peti- tion occurred within the time
p.001367: period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation
p.001367: was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may
p.001367: be made only upon demonstration by a preponderance of the evi- dence that the onset or significant
p.001367: aggravation of the injury, disability, illness, condition, or death described in the petition did in fact
p.001367: occur within the time period described in the Vac- cine Injury Table.
p.001367: (c) RECORD DEFINED.—For purposes of this section, the term ‘‘record’’ means the record established by the
p.001367: special masters of the United States Claims Court in a proceeding on a petition filed under section 2111.
p.001367: VACCINE INJURY TABLE
p.001367: SEC. 2114. ø300aa–14¿ (a) INITIAL TABLE.—The following is a table of vaccines, the injuries, disabilities,
p.001367: illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which
p.001367: the first symptom or manifestation of onset or of the significant aggravation of such injuries,
p.001367: disabilities, ill- nesses, conditions, and deaths is to occur after vaccine administra- tion for purposes of receiving
p.001367: compensation under the Program:
p.001367: VACCINE INJURY TABLE
p.001367: I. DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis
p.001367: Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
p.001367:
p.001367: Illness, disability, injury, or condi- tion covered:
p.001367:
p.001367: A. Anaphylaxis or anaphylactic
p.001367: Time period for first symptom or manifestation of onset or of sig- nificant aggravation after vaccine
p.001367: administration:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367: January 30, 2020
p.001367: shock 24 hours
p.001367: B. Encephalopathy (or encephalitis) 3 days
p.001367: C. Shock-collapse or hypotonic- hyporesponsive collapse 3 days
p.001367: D. Residual seizure disorder in ac-
p.001367: cordance with subsection (b)(2) 3 days
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
p.001367:
p.001367:
p.001367:
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p.001367:
p.001367:
p.001369: 1369
p.001369: PUBLIC HEALTH SERVICE ACT
p.001369: Sec. 2114
p.001369:
p.001369: E. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: II. Measles, mumps, rubella, or any vaccine containing any of the fore- going as a component;
p.001369: DT; Td; or Tetanus Toxoid.
p.001369: A. Anaphylaxis or anaphylactic
p.001369: shock 24 hours
p.001369: B. Encephalopathy (or encephalitis) 15 days (for mumps, rubella, mea-
p.001369: sles, or any vaccine containing any of the foregoing as a compo- nent). 3 days (for DT, Td, or
p.001369: tet- anus toxoid).
p.001369: C. Residual seizure disorder in ac-
p.001369: cordance with subsection (b)(2) .... 15 days (for mumps, rubella, mea-
p.001369: sles, or any vaccine containing any of the foregoing as a compo- nent). 3 days (for DT, Td, or
p.001369: tet- anus toxoid).
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369: January 30, 2020
p.001369: D. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: III. Polio Vaccines (other than Inac- tivated Polio Vaccine).
p.001369: A. Paralytic polio
p.001369: —in a non-immunodeficient re-
p.001369: cipient 30 days
p.001369: —in an immunodeficient recipient 6 months
p.001369: —in a vaccine-associated commu-
p.001369: nity case Not applicable
p.001369: B. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: IV. Inactivated Polio Vaccine.
p.001369: A. Anaphylaxis or anaphylactic
p.001369: shock 24 hours
p.001369: B. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: (b) QUALIFICATIONS AND AIDS TO INTERPRETATION.—The fol- lowing qualifications and aids to interpretation
p.001369: shall apply to the Vaccine Injury Table in subsection (a):
p.001369: (1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as
p.001369: decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning
p.001369: pale white or blue, un- responsiveness to environmental stimuli, depression of con-
p.001369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
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p.001369:
p.001369: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1370
p.001369: sciousness, loss of consciousness, prolonged sleeping with dif- ficulty arousing, or cardiovascular or
p.001369: respiratory arrest.
p.001369: (2) A petitioner may be considered to have suffered a resid- ual seizure disorder if the petitioner did not suffer a
p.001369: seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit
p.001369: before the first seizure or convulsion after the administration of the vaccine involved and if—
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
p.001369:
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p.001369:
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p.001369:
p.001369:
p.001371: 1371
p.001371: PUBLIC HEALTH SERVICE ACT
p.001371: Sec. 2114
p.001371:
p.001371: revision unless the revision specifies that such paragraph is to continue to apply.
p.001371: (c) ADMINISTRATIVE REVISION OF THE TABLE.—
p.001371: (1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury
p.001371: Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a
p.001371: public hearing and at least 180 days of public comment.
p.001371: (2) Any person (including the Advisory Commission on Childhood Vaccines) may petition the Secretary to propose
p.001371: reg- ulations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission,
p.001371: any such petition shall be referred to the Commission for its recommendations. Following—
p.001371: (A) receipt of any recommendation of the Commission,
p.001371: or
p.001371: (B) 180 days after the date of the referral to the Com-
p.001371: mission,
p.001371: whichever occurs first, the Secretary shall conduct a rule- making proceeding on the matters proposed in
p.001371: the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding.
p.001371: (3) A modification of the Vaccine Injury Table under para- graph (1) may add to, or delete from, the list of
p.001371: injuries, dis- abilities, illnesses, conditions, and deaths for which compensa- tion may be provided or may
p.001371: change the time periods for the first symptom or manifestation of the onset or the significant
p.001371: aggravation of any such injury, disability, illness, condition, or death.
p.001371: (4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions
p.001371: for com- pensation under the Program which are filed after the effective date of such regulation.
p.001371: (d) ROLE OF COMMISSION.—Except with respect to a regulation recommended by the Advisory Commission on Childhood
p.001371: Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary
p.001371: has first provided to the Commission a copy of the proposed regulation or revision, re- quested
p.001371: recommendations and comments by the Commission, and afforded the Commission at least 90 days to
p.001371: make such rec- ommendations.
p.001371: (e) 7 ADDITIONAL VACCINES.—
p.001371: (1) VACCINES RECOMMENDED BEFORE AUGUST 1, 1993.—By August 1, 1995, the Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a) to include—
p.001371: (A) vaccines which are recommended to the Secretary by the Centers for Disease Control and Prevention
p.001371: before August 1, 1993, for routine administration to children,
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 7 Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646) provides as follows:
p.001371: ‘‘(3) EFFECTIVE DATE.—A revision by the Secretary under section 2114(e) of the Public Health Service Act
p.001371: (42 U.S.C. 300aa–14(e)) (as amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to
p.001371: provide funds for compensation paid with respect to the vaccine to be added to the vaccine injury table in section
...

p.001383: (2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of
p.001383: such vac- cine within which vaccine-related illnesses, disabilities, inju- ries, or conditions, the
p.001383: symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and
p.001383: the manufacturer and lot number of the vaccine.
p.001383: (3) The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of the effective
p.001383: date of this part. 26
p.001383: (c) RELEASE OF INFORMATION.—
p.001383: (1) Information which is in the possession of the Federal Government and State and local governments
p.001383: under this sec- tion and which may identify an individual shall not be made available under section 552
p.001383: of title 5, United States Code, or otherwise, to any person except—
p.001383: (A) the person who received the vaccine, or
p.001383: (B) the legal representative of such person.
p.001383: (2) For purposes of paragraph (1), the term ‘‘information which may identify an individual’’ shall be limited
p.001383: to the name, street address, and telephone number of the person who re- ceived the vaccine and of that
p.001383: person’s legal representative and the medical records of such person relating to the administra- tion of the
p.001383: vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider
p.001383: who administered the vaccine, the date of the vaccination, or information concerning any reported illness,
p.001383: disability, injury, or condition resulting from the administration of the vaccine, any symptom or
p.001383: manifestation of such illness, disability, in- jury, or condition, or death resulting from the
p.001383: administration of the vaccine.
p.001383: (3) Except as provided in paragraph (1), all information re- ported under this section shall be available to the
p.001383: public.
p.001383: VACCINE INFORMATION
p.001383: SEC. 2126. ø300aa–26¿ (a) GENERAL RULE.—Not later than 1 year after the effective date of this part,
p.001383: the Secretary shall de- velop and disseminate vaccine information materials for distribu- tion by health
p.001383: care providers to the legal representatives of any child or to any other individual receiving a vaccine set
p.001383: forth in the Vaccine Injury Table. Such materials shall be published in the Fed- eral Register and may be revised.
p.001383: (b) DEVELOPMENT AND REVISION OF MATERIALS.—Such mate- rials shall be developed or revised—
p.001383:
p.001383:
p.001383:
p.001383:
p.001383: January 30, 2020
p.001383: 25 Effective December 22, 1987.
p.001383: 26 Effective December 22, 1987.
p.001383:
p.001383:
p.001383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001383:
p.001383:
p.001383:
p.001383:
p.001383:
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p.001383:
p.001383: Sec. 2127 PUBLIC HEALTH SERVICE ACT 1384
p.001383:
p.001383: (1) after notice to the public and 60 days of comment thereon, and
p.001383: (2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers
...

p.001385: law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law
p.001385: 107-296). Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or
p.001385: that Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11,
p.001385: 2002), was incorrectly decided.’’.
p.001385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001385:
p.001385:
p.001385:
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p.001387: 1387
p.001387: PUBLIC HEALTH SERVICE ACT
p.001387: Sec. 2134
p.001387:
p.001387: (2) The term ‘‘legal representative’’ means a parent or an individual who qualifies as a legal guardian
p.001387: under State law.
p.001387: (3) The term ‘‘manufacturer’’ means any corporation, orga- nization, or institution, whether public or private
p.001387: (including Federal, State, and local departments, agencies, and instru- mentalities), which manufactures,
p.001387: imports, processes, or dis- tributes under its label any vaccine set forth in the Vaccine In- jury Table, except
p.001387: that, for purposes of section 2128, such term shall include the manufacturer of any other vaccine covered by that
p.001387: section. The term ‘‘manufacture’’ means to manufacture, import, process, or distribute a vaccine.
p.001387: (4) The term ‘‘significant aggravation’’ means any change for the worse in a preexisting condition which results
p.001387: in mark- edly greater disability, pain, or illness accompanied by sub- stantial deterioration of health.
p.001387: (5) The term ‘‘vaccine-related injury or death’’ means an illness, injury, condition, or death associated with
p.001387: one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include
p.001387: an illness, injury, condition, or death associated with an adulterant or contaminant inten- tionally added
p.001387: to such a vaccine.
p.001387: (6)(A) The term ‘‘Advisory Commission on Childhood Vac- cines’’ means the Commission established under
p.001387: section 2119.
p.001387: (B) The term ‘‘Vaccine Injury Table’’ means the table set out in section 2114.
p.001387: TERMINATION OF PROGRAM
p.001387: SEC. 2134. ø300aa–34¿ (a) REVIEWS.—The Secretary shall re- view the number of awards of compensation made
p.001387: under the pro- gram to petitioners under section 2111 for vaccine-related injuries and deaths associated
p.001387: with the administration of vaccines on or after the effective date of this part 29 as follows:
p.001387: (1) The Secretary shall review the number of such awards made in the 12-month period beginning on the effective
p.001387: date of this part. 29
p.001387: (2) At the end of each 3-month period beginning after the expiration of the 12-month period referred to in
p.001387: paragraph (1) the Secretary shall review the number of such awards made in the 3-month period.
p.001387: (b) REPORT.—
p.001387: (1) If in conducting a review under subsection (a) the Sec- retary determines that at the end of the period
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p.001389: after the date of the qualifying event described in section 2203(2).
p.001389: (iii) GENERAL RULE FOR OTHER QUALIFYING EVENTS.—In the case of a qualifying event not de-
p.001389: scribed in section 2203(2), the date which is 36 months after the date of the qualifying event.
p.001389: (iv) SPECIAL RULE FOR TAA-ELIGIBLE INDIVID- UALS.—In the case of a qualifying event described in
p.001389: section 2203(2) with respect to a covered employee who is (as of the date that the period of coverage
p.001389: would, but for this clause or clause (v), otherwise ter- minate under clause (i) or (ii)) a
p.001389: TAA-eligible indi- vidual (as defined in section 2205(b)(4)(B)), the period of coverage shall not terminate by reason
p.001389: of clause (i) or (ii), as the case may be, before the later of the date specified in such clause or the date on which
p.001389: such in- dividual ceases to be such a TAA-eligible individual. The preceding sentence shall not require any
p.001389: period of coverage to extend beyond January 1, 2014.
p.001389: (v) MEDICARE ENTITLEMENT FOLLOWED BY QUALI- FYING EVENT.—In the case of a qualifying event de- scribed
p.001389: in section 2203(2) that occurs less than 18 months after the date the covered employee became entitled
p.001389: to benefits under title XVIII of the Social Se- curity Act, the period of coverage for qualified bene-
p.001389: ficiaries other than the covered employee shall not ter- minate under this subparagraph before the close of the
p.001389: 36-month period beginning on the date the covered employee became so entitled.
p.001389: (vi) SPECIAL RULE FOR DISABILITY.—In the case of a qualified beneficiary who is determined, under title
p.001389: II or XVI of the Social Security Act, to have been dis- abled at any time during the first 60 days of continu- ation
p.001389: coverage under this title, any reference in clause
p.001389:
p.001389:
p.001389:
p.001389: January 30, 2020
p.001389: 1 So in law. This title is not divided into parts.
p.001389: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001389:
p.001389:
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p.001389:
p.001389: Sec. 2202 PUBLIC HEALTH SERVICE ACT 1390
p.001389:
p.001389: (i) or (ii) to 18 months with respect to such event 2 is deemed a reference to 29 months (with
p.001389: respect to all qualified beneficiaries), but only if the qualified bene- ficiary has provided notice
p.001389: of such determination under section 2206(3) before the end of such 18 months.
p.001389: (B) END OF PLAN.—The date on which the employer ceases to provide any group health plan to any
p.001389: employee.
p.001389: (C) FAILURE TO PAY PREMIUM.—The date on which cov- erage ceases under the plan by reason of a failure to make timely
p.001389: payment of any premium required under the plan with respect to the qualified beneficiary. The payment of
p.001389: any premium (other than any payment referred to in the last sentence of paragraph (3)) shall be
p.001389: considered to be timely if made within 30 days after the date due or within such longer period as applies to or under
p.001389: the plan.
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p.001417: Sec. 2402 PUBLIC HEALTH SERVICE ACT 1418
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p.001417: January 30, 2020
p.001417:
p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
p.001417: (3) The term ‘‘chronically dependent’’ means, with respect to an individual, that the individual has been
p.001417: certified by a physician as—
p.001417: (A) being unable to perform, because of physical or cognitive impairment (without substantial assistance
p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
p.001417: (C) day treatment or other partial hospitalization serv- ices,
p.001417: (D) home intravenous drug therapy (including pre- scription drugs administered intravenously as part of such
p.001417: therapy), and
p.001417: (E) routine diagnostic tests administered in the indi- vidual’s home,
p.001417: furnished pursuant to such plan of care; but
p.001417: (3) does not include, except as specifically provided in paragraph (2)—
p.001417: (A) diagnostic tests,
p.001417: (B) inpatient hospital services,
p.001417: (C) nursing facility services, and
...

p.001549: from those described in such paragraph, to address adverse se- lection as approved by the State insurance commissioner
p.001549: or of- ficial or officials designated by the State to enforce the require- ments of this part for the State
p.001549: involved with respect to such issuer.
p.001549: SEC. 2705. ø300gg–4¿ PROHIBITING DISCRIMINATION AGAINST INDI- VIDUAL PARTICIPANTS AND BENEFICIARIES BASED ON
p.001549: HEALTH STATUS.
p.001549: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001549: coverage may not establish rules for eligibility (including continued eligibility) of any individual to enroll
p.001549: under the terms of the plan or coverage based on any of the following health status-related factors in rela-
p.001549: tion to the individual or a dependent of the individual:
p.001549: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001549:
p.001549:
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p.001549: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1550
p.001549:
p.001549: (1) Health status.
p.001549: (2) Medical condition (including both physical and mental illnesses).
p.001549: (3) Claims experience.
p.001549: (4) Receipt of health care.
p.001549: (5) Medical history.
p.001549: (6) Genetic information.
p.001549: (7) Evidence of insurability (including conditions arising out of acts of domestic violence).
p.001549: (8) Disability.
p.001549: (9) Any other health status-related factor determined ap- propriate by the Secretary.
p.001549: (b) IN PREMIUM CONTRIBUTIONS.—
p.001549: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001549: insurance cov- erage, may not require any individual (as a condition of enroll- ment or continued enrollment under
p.001549: the plan) to pay a pre- mium or contribution which is greater than such premium or contribution for a
p.001549: similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to
p.001549: the individual or to an individual enrolled under the plan as a dependent of the individual.
p.001549: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued—
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p.001549: January 30, 2020
p.001549: (A) to restrict the amount that an employer or indi- vidual may be charged for coverage under a group
p.001549: health plan except as provided in paragraph (3) or individual health coverage, as the case may be; or
p.001549: (B) to prevent a group health plan, and a health insur- ance issuer offering group health insurance coverage, from
p.001549: establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in
p.001549: return for adherence to programs of health promotion and disease prevention.
p.001549: (3) NO GROUP-BASED DISCRIMINATION ON BASIS OF GENETIC INFORMATION.—
...

p.001611: (2) HEALTH INSURANCE ISSUER.—The term ‘‘health insur- ance issuer’’ means an insurance company, insurance
p.001611: service, or insurance organization (including a health maintenance or- ganization, as defined in paragraph (3))
p.001611: which is licensed to en- gage in the business of insurance in a State and which is sub- ject to State law which
p.001611: regulates insurance (within the mean- ing of section 514(b)(2) of the Employee Retirement Income Se- curity Act of
p.001611: 1974). Such term does not include a group health plan.
p.001611: (3) HEALTH MAINTENANCE ORGANIZATION.—The term ‘‘health maintenance organization’’ means—
p.001611: (A) a Federally qualified health maintenance organiza- tion (as defined in section 1301(a)),
p.001611: (B) an organization recognized under State law as a health maintenance organization, or
p.001611: (C) a similar organization regulated under State law for solvency in the same manner and to the same
p.001611: extent as such a health maintenance organization.
p.001611: (4) GROUP HEALTH INSURANCE COVERAGE.—The term ‘‘group health insurance coverage’’ means, in connection
p.001611: with a group health plan, health insurance coverage offered in connec- tion with such plan.
p.001611: (5) INDIVIDUAL HEALTH INSURANCE COVERAGE.—The term ‘‘individual health insurance coverage’’ means health
p.001611: insurance coverage offered to individuals in the individual market, but does not include short-term limited
p.001611: duration insurance.
p.001611: (c) EXCEPTED BENEFITS.—For purposes of this title, the term ‘‘excepted benefits’’ means benefits under one or
p.001611: more (or any com- bination thereof) of the following:
p.001611: (1) BENEFITS NOT SUBJECT TO REQUIREMENTS.—
p.001611: (A) Coverage only for accident, or disability income in- surance, or any combination thereof.
p.001611: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001611:
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p.001613: PUBLIC HEALTH SERVICE ACT
p.001613: Sec. 2791
p.001613:
p.001613: (B) Coverage issued as a supplement to liability insurance.
p.001613: (C) Liability insurance, including general liability in- surance and automobile liability insurance.
p.001613: (D) Workers’ compensation or similar insurance.
p.001613: (E) Automobile medical payment insurance.
p.001613: (F) Credit-only insurance.
p.001613: (G) Coverage for on-site medical clinics.
p.001613: (H) Other similar insurance coverage, specified in reg- ulations, under which benefits for medical care are
p.001613: sec- ondary or incidental to other insurance benefits.
p.001613: (2) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED SEPARATELY.—
p.001613: (A) Limited scope dental or vision benefits.
p.001613: (B) Benefits for long-term care, nursing home care, home health care, community-based care, or any combina- tion
p.001613: thereof.
p.001613: (C) Such other similar, limited benefits as are speci- fied in regulations.
p.001613: (3) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS INDEPENDENT, NONCOORDINATED BENEFITS.—
p.001613: (A) Coverage only for a specified disease or illness.
p.001613: (B) Hospital indemnity or other fixed indemnity insurance.
...

p.001637: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001637: (B) The Administrator of the Administration for Com- munity Living.
p.001637: (C) The Director of the Biomedical Advanced Research and Development Authority.
p.001637: (D) The Director of the Centers for Disease Control and Prevention.
p.001637: (E) The Commissioner of Food and Drugs.
p.001637: (F) The Director of the National Institutes of Health.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001637:
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p.001637: Sec. 2811D PUBLIC HEALTH SERVICE ACT 1638
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p.001637: January 30, 2020
p.001637:
p.001637: (G) The Administrator of the Federal Emergency Man- agement Agency.
p.001637: (H) The Chair of the National Council on Disability.
p.001637: (I) The Chair of the United States Access Board.
p.001637: (J) The Under Secretary for Health of the Department of Veterans Affairs.
p.001637: (K) At least 2 non-Federal health care professionals with expertise in disability accessibility before, during,
p.001637: and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.
p.001637: (L) At least 2 representatives from State, local, Tribal, or territorial agencies with expertise in disaster
p.001637: planning, preparedness, response, or recovery for individuals with disabilities.
p.001637: (M) At least 2 individuals with a disability with exper- tise in disaster planning, preparedness, response, or recov-
p.001637: ery for individuals with disabilities.
p.001637: (d) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (e) DISABILITY DEFINED.—For purposes of this section, the term ‘‘disability’’ has the meaning given such term in
p.001637: section 3 of the Americans with Disabilities Act of 1990.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) RECOMMENDATION.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommendation on whether the Advisory Committee should be extended.
p.001637: SEC. 2811D. ø42 U.S.C. 300hh-10e¿ ADVISORY COMMITTEE COORDINA- TION.
p.001637: (a) IN GENERAL.—The Secretary shall coordinate duties and ac- tivities authorized under sections 2811A, 2811B,
p.001637: and 2811C, and make efforts to reduce unnecessary or duplicative reporting, or un- necessary duplicative meetings
p.001637: and recommendations under such sections, as practicable. Members of the advisory committees au- thorized
p.001637: under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate,
p.001637: that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and
p.001637: individuals with disabilities dur- ing public health emergencies. If such coordination occurs through an in-person
p.001637: meeting, it shall not be considered the required in- person meetings under any of sections
p.001637: 2811A(e), 2811B(e), or 2811C(d).
p.001637: (b) COORDINATION AND ALIGNMENT.—The Secretary, acting through the employee designated pursuant to
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p.001647: and re- lated outbreaks; and
p.001647: (C) other relevant activities identified by the Director of the Centers for Disease Control and
p.001647: Prevention, as ap- propriate;
p.001647: (2) the manner in which the applicant will coordinate with other Federal, Tribal, and State agencies and programs, as
p.001647: ap- plicable, related to vector-borne diseases, as well as other rel- evant public and private organizations
p.001647: or agencies; and
p.001647: (3) the manner in which the applicant will evaluate the ef- fectiveness of any program carried out under the
p.001647: cooperative agreement.
p.001647: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purposes of carrying out this section, there are authorized
p.001647: to be appropriated
p.001647: $20,000,000 for each of fiscal years 2021 through 2025.
p.001647: TITLE XXIX—LIFESPAN RESPITE CARE
p.001647:
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p.001647: January 30, 2020
p.001647: SEC. 2901. ø300ii¿ DEFINITIONS.
p.001647: In this title:
p.001647: (1) ADULT WITH A SPECIAL NEED.—The term ‘‘adult with a special need’’ means a person 18 years of age or older
p.001647: who re- quires care or supervision to—
p.001647: (A) meet the person’s basic needs;
p.001647: (B) prevent physical self-injury or injury to others; or
p.001647: (C) avoid placement in an institutional facility.
p.001647: (2) AGING AND DISABILITY RESOURCE CENTER.—The term ‘‘aging and disability resource center’’ means an
p.001647: entity admin- istering a program established by the State, as part of the State’s system of long-term
p.001647: care, to provide a coordinated sys- tem for providing—
p.001647: (A) comprehensive information on available public and private long-term care programs, options, and resources;
p.001647: (B) personal counseling to assist individuals in assess- ing their existing or anticipated long-term care needs, and
p.001647: developing and implementing a plan for long-term care de- signed to meet their specific needs and circumstances; and
p.001647: (C) consumer access to the range of publicly supported long-term care programs for which consumers may be eli-
p.001647: gible, by serving as a convenient point of entry for such programs.
p.001647: (3) CHILD WITH A SPECIAL NEED.—The term ‘‘child with a special need’’ means an individual less than 18
p.001647: years of age who requires care or supervision beyond that required of chil- dren generally to—
p.001647: (A) meet the child’s basic needs; or
p.001647: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001647:
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p.001649: PUBLIC HEALTH SERVICE ACT
p.001649: Sec. 2902
p.001649:
p.001649: (B) prevent physical injury, self-injury, or injury to others.
p.001649: (4) ELIGIBLE STATE AGENCY.—The term ‘‘eligible State agency’’ means a State agency that—
p.001649: (A) administers the State’s program under the Older Americans Act of 1965, administers the State’s
p.001649: program under title XIX of the Social Security Act, or is designated by the Governor of such State to administer
p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
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p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
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p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
...

p.001697: (a) DATA COLLECTION.—
p.001697: (1) IN GENERAL.—The Secretary shall ensure that, by not later than 2 years after the date of enactment of this
p.001697: title, any federally conducted or supported health care or public health program, activity or survey (including
p.001697: Current Population Sur- veys and American Community Surveys conducted by the Bu-
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
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p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
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p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
p.001699: activity, the Secretary shall analyze data collected under paragraph (a) to detect and monitor trends in
p.001699: health disparities (as defined for purposes of section 485E) at the Federal and State levels.
p.001699: (c) DATA REPORTING AND DISSEMINATION.—
p.001699: (1) IN GENERAL.—The Secretary shall make the analyses described in (b) available to—
p.001699: (A) the Office of Minority Health;
p.001699: (B) the National Center on Minority Health and Health Disparities;
p.001699: (C) the Agency for Healthcare Research and Quality;
p.001699: (D) the Centers for Disease Control and Prevention;
p.001699: (E) the Centers for Medicare & Medicaid Services;
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p.000001: shall be credited with one year for purposes of promotion and se- niority in grade, except that no
p.000001: such credit shall be authorized if the officer has received or will receive similar credit for his intern- ship
p.000001: under other provisions of law. In the case of an officer on ac- tive duty on the effective date of this section who is
p.000001: entitled to the credit authorized herein, the one year shall be added to the pro- motion and
p.000001: seniority-in-grade credits with which he is credited on such date.
p.000001: RIGHTS, PRIVILEGES, ETC. OF OFFICERS AND SURVIVING BENEFICIARIES
p.000001: SEC. 221. ø213a¿ (a) Commissioned officers of the Service or their surviving beneficiaries are entitled to all
p.000001: the rights, benefits, privileges, and immunities now or hereafter provided for commis- sioned officers of
p.000001: the Army or their surviving beneficiaries under the following provisions of title 10, United States Code:
p.000001: (1) Section 1036, Escorts for dependents of members: transportation and travel allowances.
p.000001: (2) Chapter 61, Retirement or Separation for Physical Dis- ability, except that sections 1201, 1202, and 1203 do not
p.000001: apply to commissioned officers of the Public Health Service who have been ordered to active duty for training
p.000001: for a period of more than 30 days.
p.000001: (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a).
p.000001: (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401.
p.000001: (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan.
p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
...

p.000001:
p.000001: clude the Secretary from approving the application (and 10 thereby restoring the applicability of this
p.000001: subsection to the en- tity and each officer, governing board member, employee, and contractor of the entity,
p.000001: subject to the provisions of this sub- section and the subsequent provisions of this section.
p.000001: (2) If, with respect to an entity or person deemed to be an em- ployee for purposes of paragraph (1), a cause of action
p.000001: is instituted against the United States pursuant to this section, any claim of the entity or person for benefits under
p.000001: an insurance policy with respect to medical malpractice relating to such cause of action shall be sub- rogated to the
p.000001: United States.
p.000001: (3) This subsection shall apply with respect to a cause of action arising from an act or omission which occurs
p.000001: on or after January 1, 1993.
p.000001: (4) An entity described in this paragraph is a public or non- profit private entity receiving Federal funds
p.000001: under section 330.
p.000001: (5) For purposes of paragraph (1), an individual may be consid- ered a contractor of an entity described in
p.000001: paragraph (4) only if—
p.000001: (A) the individual normally performs on average at least 321⁄2 hours of service per week for the entity
p.000001: for the period of the contract; or
p.000001: (B) in the case of an individual who normally performs an average of less than 321⁄2 hours of services per week for the
p.000001: en- tity for the period of the contract, the individual is a licensed or certified provider of services in
p.000001: the fields of family practice, general internal medicine, general pediatrics, or obstetrics and gynecology.
p.000001: (h) The Secretary may not approve an application under sub- section (g)(1)(D) unless the Secretary
p.000001: determines that the entity—
p.000001: (1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits
p.000001: arising out of any health or health-related functions performed by the entity;
p.000001: (2) has reviewed and verified the professional credentials, references, claims history, fitness,
p.000001: professional review organi- zation findings, and license status of its physicians and other licensed or
p.000001: certified health care practitioners, and, where nec- essary, has obtained the permission from these
p.000001: individuals to gain access to this information;
p.000001: (3) has no history of claims having been filed against the United States as a result of the
p.000001: application of this section to the entity or its officers, employees, or contractors as provided for under this
p.000001: section, or, if such a history exists, has fully co- operated with the Attorney General in defending against
p.000001: any such claims and either has taken, or will take, any necessary corrective steps to assure against
p.000001: such claims in the future; and
p.000001: (4) will fully cooperate with the Attorney General in pro-
p.000001: viding information relating to an estimate described under sub- section (k).
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p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
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p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 306 PUBLIC HEALTH SERVICE ACT 80
p.000017: ments for health care services, and Federal, State, and local governmental expenditures for health care
p.000017: services, and
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p.000017: (H) family formation, growth, and dissolution;
p.000017: (2) shall undertake and support (by grant or contract) re- search, demonstrations, and evaluations respecting
p.000017: new or im- proved methods for obtaining current data on the matters re- ferred to in paragraph (1);
p.000017: (3) may undertake and support (by grant or contract) epi- demiological research, demonstrations, and
p.000017: evaluations on the matters referred to in paragraph (1); and
p.000017: (4) may collect, furnish, tabulate, and analyze statistics, and prepare studies, on matters referred to
p.000017: in paragraph (1) upon request of public and nonprofit private entities under ar- rangements under which the
p.000017: entities will pay the cost of the service provided.
p.000017: Amounts appropriated to the Secretary from payments made under arrangements made under paragraph (4) shall be
p.000017: available to the Secretary for obligation until expended.
p.000017: (c) The Center shall furnish such special statistical and epide- miological compilations and surveys as the
p.000017: Committee on Labor and Human Resources and the Committee on Appropriations of the Senate and the Committee on Energy
p.000017: and Commerce and the Com- mittee on Appropriations of the House of Representatives may re- quest. Such
p.000017: statistical and epidemiological compilations and sur- veys shall not be made subject to the payment of the actual
p.000017: or esti- mated cost of the preparation of such compilations and surveys.
p.000017: (d) To insure comparability and reliability of health statistics, the Secretary shall, through the Center,
p.000017: provide adequate technical assistance to assist State and local jurisdictions in the development of model laws
p.000017: dealing with issues of confidentiality and com- parability of data.
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p.000017:
p.000017: 99 PUBLIC HEALTH SERVICE ACT Sec. 317
p.000017:
p.000017: related fields while a member of the Armed Forces of the United States; and
p.000017: (B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed
p.000017: Forces of the United States to forgo or meet any such equivalent State requirements; and
p.000017: (2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to
p.000017: meet certification, licensure or other requirements applicable to becoming a civil- ian health care professional
p.000017: (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse,
p.000017: physical therapy assistant, or physician assistant pro- fessions) in the State, develop or expand career pathways
p.000017: at in- stitutions of higher education to support veterans in meeting such requirements.
p.000017: (c) REPORT.—Upon the completion of the demonstration pro- gram under this section, the Secretary shall
p.000017: submit to Congress a report on the program.
p.000017: (d) FUNDING.—No additional funds are authorized to be appro- priated for the purpose of carrying out this
p.000017: section. This section shall be carried out using amounts otherwise available for such purpose.
p.000017: (e) SUNSET.—The demonstration program under this section shall not exceed 5 years.
p.000017: FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
p.000017: SEC. 316. 8 ø247a¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute
p.000017: of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the
p.000017: establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to
p.000017: assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of
p.000017: such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
p.000017: (1) university medical centers and other appropriate health care facilities which receive Federal funds from the
p.000017: Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such
p.000017: disease; and
p.000017: (2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
p.000017: (b) The Secretary shall promote the establishment of a national network to coordinate the family support groups
p.000017: described in sub- section (a).
p.000017: PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES
p.000017: SEC. 317. ø247b¿ (a) The Secretary may make grants to States, and in consultation with State health authorities,
p.000017: to political sub- divisions of States and to other public entities to assist them in
p.000017:
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p.000017: January 30, 2020
p.000017: 8 With respect to section 315, subsection (d) of such section provided as follows: ‘‘This section shall cease to exist
p.000017: on March 31, 1989.’’. See section 1 of Public Law 100–471 (102 Stat. 2284).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 317 PUBLIC HEALTH SERVICE ACT 100
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p.000125: (2) ACTIVITIES.—For the purpose described in paragraph (1), the Secretary, acting through the Director of
p.000125: the Centers for Disease Control and Prevention, may carry out the fol- lowing activities:
p.000125: (A) The Secretary may continue and improve activities related to a national maternal mortality data collection
p.000125: and surveillance program to identify and support the re- view of pregnancy-associated deaths and
p.000125: pregnancy-related deaths that occur during, or within 1 year following, preg- nancy.
p.000125: (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and
p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
...

p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
p.000127: regardless of the outcome of the pregnancy.
p.000127: (2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian tribes, and tribal organizations that participate in the
p.000127: program described in this subsection shall, through the State maternal mortality review committee, develop a
p.000127: process that—
p.000127: (A) provides for confidential case reporting of preg- nancy-associated and pregnancy-related deaths to the
p.000127: ap- propriate State or tribal health agency, including such re- porting by—
p.000127: (i) health care professionals;
p.000127: (ii) health care facilities;
p.000127: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000127:
p.000127:
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p.000127: Sec. 317K PUBLIC HEALTH SERVICE ACT 128
p.000127:
p.000127: (iii) any individual responsible for completing death records, including medical examiners and med-
p.000127: ical coroners; and
p.000127: (iv) other appropriate individuals or entities; and
p.000127: (B) provides for voluntary and confidential case report- ing of pregnancy-associated deaths and pregnancy-related
p.000127: deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate in-
p.000127: dividuals, for purposes of review by the applicable mater- nal mortality review committee; and
p.000127: (C) shall include—
p.000127: (i) making publicly available contact information of the committee for use in such reporting; and
p.000127: (ii) conducting outreach to local professional orga- nizations, community organizations, and social serv- ices
p.000127: agencies regarding the availability of the review committee.
p.000127: (3) DATA COLLECTION AND REVIEW.—States, Indian tribes, and tribal organizations that participate in
p.000127: the program de- scribed in this subsection shall—
p.000127: (A) annually identify pregnancy-associated deaths and pregnancy-related deaths—
p.000127: (i) through the appropriate vital statistics unit by—
p.000127:
p.000127:
p.000127:
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p.000127:
p.000127: January 30, 2020
p.000127: (I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the
p.000127: State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as
p.000127: applicable;
p.000127: (II) to the extent practicable, identifying an underlying or contributing cause of each preg-
p.000127: nancy-associated death and each pregnancy-re- lated death in the State or tribal area in the ap-
p.000127: plicable year; and
p.000127: (III) collecting data from medical examiner and coroner reports, as appropriate;
...

p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
p.000129:
p.000129:
p.000129:
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p.000129: January 30, 2020
p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000129:
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p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
p.000135:
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p.000135:
p.000135:
p.000135:
p.000135:
p.000135:
p.000135: January 30, 2020
p.000135:
p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000135:
p.000135:
p.000135:
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p.000135:
p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
p.000135:
p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
...

p.000151: ceding the fiscal year for which the applicant is applying to receive such a grant.
p.000151: (l) REQUIREMENT OF APPLICATION.—
p.000151: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if an application for the grant is
p.000151: submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such
p.000151: form, is made in such manner, and contains such agreements, assurances, and information as the Secretary
p.000151: determines to be necessary to carry out this section.
p.000151: (2) SUBMISSION OF PLAN FOR PROGRAM OF GRANTEE.—
p.000151: (A) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the applicant involved submits to
p.000151: the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a
p.000151: condition of receiving such a grant, including a specifica- tion of the entities through which activities
p.000151: authorized in subsection (c) will be provided.
p.000151: (B) PARTICIPATION OF CERTAIN ENTITIES.—The Sec- retary may make a grant under subsection (a) only if
p.000151: the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has
p.000151: been prepared in consultation with an appropriate number and variety of—
p.000151: (i) representatives of entities in the geographic area involved that provide services for the prevention
p.000151: and control of sexually transmitted diseases, including programs to provide to the public information and edu- cation
p.000151: regarding such diseases; and
p.000151: (ii) representatives of entities in such area that provide family planning services.
p.000151: (m) DURATION OF GRANT.—The period during which payments are made to an entity from a grant under subsection
p.000151: (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary
p.000151: of the payments and subject to the availability of appropriations for the fiscal year involved to make
p.000151: the payments in such year. The preceding sentence may not be construed to establish a limitation on the number
p.000151: of grants under such subsection that may be made to an entity.
p.000151: (n) TECHNICAL ASSISTANCE, AND SUPPLIES AND SERVICES IN
p.000151: LIEU OF GRANT FUNDS.—
p.000151: (1) TECHNICAL ASSISTANCE.—The Secretary may provide training and technical assistance to grantees under subsection
p.000151: (a) with respect to the planning, development, and operation of any program or service carried out under such
p.000151: subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
p.000151: (2) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The Secretary, at the request of a recipient of a
p.000151: grant under sub- section (a), may reduce the amount of such grant by—
p.000151: (A) the fair market value of any supplies or equipment furnished the grant recipient; and
p.000151: (B) the amount of the pay, allowances, and travel ex- penses of any officer or employee of the Government when
p.000151: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000151:
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p.000257: Sec. 330 PUBLIC HEALTH SERVICE ACT 258
p.000257:
p.000257: is medically underserved, or a special medically underserved population comprised of migratory and seasonal
p.000257: agricultural workers, the homeless, and residents of public housing, by pro- viding, either through the staff and
p.000257: supporting resources of the center or through contracts or cooperative arrangements—
p.000257: (A) required primary health services (as defined in subsection (b)(1)); and
p.000257: (B) as may be appropriate for particular centers, addi- tional health services (as defined in subsection (b)(2)) nec-
p.000257: essary for the adequate support of the primary health services required under subparagraph (A);
p.000257: for all residents of the area served by the center (hereafter re- ferred to in this section as the ‘‘catchment area’’).
p.000257: (2) LIMITATION.—The requirement in paragraph (1) to pro- vide services for all residents within a catchment
p.000257: area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i).
p.000257: (b) DEFINITIONS.—For purposes of this section:
p.000257: (1) REQUIRED PRIMARY HEALTH SERVICES.—
p.000257: (A) IN GENERAL.—The term ‘‘required primary health services’’ means—
p.000257: (i) basic health services which, for purposes of this section, shall consist of—
p.000257: (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology
p.000257: that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse
p.000257: midwives;
p.000257: (II) diagnostic laboratory and radiologic serv- ices;
p.000257: (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening;
p.000257: (cc) well-child services;
p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
p.000257: (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol;
p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
p.000257:
p.000257:
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p.000257: January 30, 2020
p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000257:
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p.000259: 259
p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
...

p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
p.000265: (A) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ means an individual who lacks housing (without
p.000265: regard to whether the individual is a member of a family), including an individual whose primary residence during
p.000265: the night is a supervised public or private facility that pro- vides temporary living accommodations and an
p.000265: individual who is a resident in transitional housing.
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000265:
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p.000267: 267
p.000267: PUBLIC HEALTH SERVICE ACT
p.000267: Sec. 330
p.000267:
p.000267: (B) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘substance abuse 31services’’ includes detoxification,
p.000267: risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse 31 provided
p.000267: in settings other than hospitals.
p.000267: (i) RESIDENTS OF PUBLIC HOUSING.—
p.000267: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000267: the plan- ning and delivery of services to a special medically under- served population comprised of
p.000267: residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term
p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
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p.000285:
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p.000285:
p.000285: Sec. 330F PUBLIC HEALTH SERVICE ACT 286
p.000285:
p.000285: (4) ADOPTION ORGANIZATIONS; ELIGIBLE HEALTH CENTERS; OTHER DEFINITIONS.—For purposes of this section:
p.000285: (A) The term ‘‘adoption organization’’ means a na- tional, regional, or local organization—
p.000285: (i) among whose primary purposes are adoption;
p.000285: (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa-
p.000285: tion and referrals to pregnant women; and
p.000285: (iii) that is a nonprofit private entity.
p.000285: (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who
p.000285: provide pregnancy or adoption information and referrals (or will provide such information and referrals
p.000285: after receiving training under a grant under paragraph (1)).
p.000285: (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health
p.000285: services to pregnant women.
p.000285: (5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A condition for the receipt of a grant under paragraph (1) is
p.000285: that the adoption organization involved agree to make reasonable efforts to ensure that the eligible
p.000285: health centers with respect to which training under the grant is provided include—
p.000285: (A) eligible health centers that receive grants under section 1001 (relating to voluntary family
p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
...

p.000293: (E) CONNECTIVITY.—The eligible entity proposes a project that promotes local connectivity within areas, com-
p.000293: munities, or populations to be served through the project.
p.000293: (F) INTEGRATION.—The eligible entity demonstrates that health care information has been integrated into
p.000293: the project.
p.000293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000293:
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p.000293: Sec. 330I PUBLIC HEALTH SERVICE ACT 294
p.000293:
p.000293: (2) TELEHEALTH RESOURCE CENTERS.—In awarding grants under subsection (d)(2) for projects involving
p.000293: telehealth re- source centers, the Secretary shall give preference to an eligi- ble entity that meets at
p.000293: least 1 of the following requirements:
p.000293: (A) PROVISION OF SERVICES.—The eligible entity has a record of success in the provision of telehealth services
p.000293: to medically underserved areas or medically underserved populations.
p.000293: (B) COLLABORATION AND SHARING OF EXPERTISE.—The eligible entity has a demonstrated record of collaborating
p.000293: and sharing expertise with providers of telehealth services at the national, regional, State, and local levels.
p.000293: (C) BROAD RANGE OF TELEHEALTH SERVICES.—The eli- gible entity has a record of providing a broad range of tele-
p.000293: health services, which may include—
p.000293: (i) a variety of clinical specialty services;
p.000293: (ii) patient or family education;
p.000293: (iii) health care professional education; and
p.000293: (iv) rural residency support programs.
p.000293: (j) DISTRIBUTION OF FUNDS.—
p.000293: (1) IN GENERAL.—In awarding grants under this section, the Director shall ensure, to the greatest extent
p.000293: possible, that such grants are equitably distributed among the geographical regions of the United States.
p.000293: (2) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for a fiscal year, the Director shall
p.000293: ensure that—
p.000293:
p.000293:
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p.000293: January 30, 2020
p.000293: (A) not less than 50 percent of the funds awarded shall be awarded for projects in rural areas; and
p.000293: (B) the total amount of funds awarded for such projects for that fiscal year shall be not less than the
p.000293: total amount of funds awarded for such projects for fiscal year 2001 under section 330A (as in effect on the
p.000293: day before the date of enactment of the Health Care Safety Net Amend- ments of 2002).
p.000293: (k) USE OF FUNDS.—
p.000293: (1) TELEHEALTH NETWORK PROGRAM.—The recipient of a grant under subsection (d)(1) may use funds received
p.000293: through such grant for salaries, equipment, and operating or other costs, including the cost of—
...

p.000301: toward such costs in an amount that is not less than 20 percent of Federal funds provided in the
p.000301: grant.
p.000301: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated, $9,000,000
p.000301: for the pe- riod of fiscal years 2018 through 2022.
p.000301: Subpart II—National Health Service Corps Program
p.000301: NATIONAL HEALTH SERVICE CORPS
p.000301: SEC. 331. ø254d¿ (a)(1) For the purpose of eliminating health manpower 38 shortages in health professional
p.000301: shortage areas, there is established, within the Service, the National Health Service Corps, which shall
p.000301: consist of—
p.000301: (A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
p.000301: (B) such civilian employees of the United States as the Secretary may appoint, and
p.000301: (C) such other individuals who are not employees of the United States.
p.000301: (2) The Corps shall be utilized by the Secretary to provide pri- mary health services in health professional shortage
p.000301: areas.
p.000301: (3) For purposes of this subpart and subpart III:
p.000301: (A) The term ‘‘Corps’’ means the National Health Service Corps.
p.000301: (B) The term ‘‘Corps member’’ means each of the officers, employees, and individuals of which the Corps
p.000301: consists pursu- ant to paragraph (1).
p.000301: (C) The term ‘‘health professional shortage area’’ has the meaning given such term in section 332(a).
p.000301: (D) The term ‘‘primary health services’’ means health serv- ices regarding family medicine, internal medicine,
p.000301: pediatrics, obstetrics and gynecology, dentistry, or mental health, that are provided by physicians or other health
p.000301: professionals.
p.000301: (E)(i) The term ‘‘behavioral and mental health profes- sionals’’ means health service psychologists,
p.000301: licensed clinical social workers, licensed professional counselors, marriage and family therapists,
p.000301: psychiatric nurse specialists, and psychia- trists.
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p.000301: 38 So in law. Probably should be ‘‘health professional shortages’’. See section 401 of Public Law 101–597 (104 Stat.
p.000301: 3035).
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p.000303: PUBLIC HEALTH SERVICE ACT
p.000303: Sec. 331
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p.000303: January 30, 2020
p.000303: (ii) The term ‘‘graduate program of behavioral and mental health’’ means a program that trains behavioral and
p.000303: mental health professionals.
p.000303: (b)(1) The Secretary may conduct at schools of medicine, osteo- pathic medicine, dentistry, and, as appropriate,
p.000303: nursing and other schools of the health professions, including schools at which grad- uate programs of
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p.000303: shall include efforts to recruit individuals who will serve in the Corps other than pursuant to obli- gated
p.000303: service under the Scholarship or Loan Repayment Program.
p.000303: (2) In the case of physicians, dentists, behavioral and mental health professionals, certified nurse midwives,
p.000303: certified nurse prac- titioners, and physician assistants who have an interest and a com- mitment to providing
p.000303: primary health care, the Secretary may es- tablish fellowship programs to enable such health professionals
p.000303: to gain exposure to and expertise in the delivery of primary health services in health professional shortage
p.000303: areas. To the maximum ex- tent practicable, the Secretary shall ensure that any such programs are established in
p.000303: conjunction with accredited residency programs, and other training programs, regarding such health professions.
p.000303: (c)(1) The Secretary may reimburse an applicant for a position in the Corps (including an individual considering
p.000303: entering into a written agreement pursuant to section 338D) for the actual and reasonable expenses
p.000303: incurred in traveling to and from the appli- cant’s place of residence to an eligible site to which
p.000303: the applicant may be assigned under section 333 for the purpose of evaluating such site with regard to being
p.000303: assigned at such site. The Secretary may establish a maximum total amount that may be paid to an in- dividual as
p.000303: reimbursement for such expenses.
p.000303: (2) The Secretary may also reimburse the applicant for the ac- tual and reasonable expenses incurred for the
p.000303: travel of 1 family member to accompany the applicant to such site. The Secretary may establish a maximum
p.000303: total amount that may be paid to an in- dividual as reimbursement for such expenses.
p.000303: (3) In the case of an individual who has entered into a contract for obligated service under the Scholarship
p.000303: Program or under the Loan Repayment Program, the Secretary may reimburse such indi- vidual for all or part of
p.000303: the actual and reasonable expenses in- curred in transporting the individual, the individual’s family, and
p.000303: the family’s possessions to the site of the individual’s assignment under section 333. The Secretary may
p.000303: establish a maximum total amount that may be paid to an individual as reimbursement for such expenses.
p.000303: (d)(1) The Secretary may, under regulations promulgated by the Secretary, adjust the monthly pay of each member
p.000303: of the Corps (other than a member described in subsection (a)(1)(C)) who is di- rectly engaged in the
p.000303: delivery of health services in a health profes- sional shortage area as follows:
p.000303: (A) During the first 36 months in which such a member is so engaged in the delivery of health services, his
p.000303: monthly pay may be increased by an amount which when added to the member’s monthly pay and allowances
p.000303: will provide a monthly
p.000303: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000303: Sec. 331 PUBLIC HEALTH SERVICE ACT 304
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p.000333: 332) selected by the Secretary.
p.000333: (b)(1) The written agreement described in subsection (a) shall—
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p.000333: January 30, 2020
p.000333: (A) provide that, during the period of private practice by an individual pursuant to the agreement, the
p.000333: individual shall comply with the requirements of section 334 that apply to enti- ties; and
p.000333: (B) contain such additional provisions as the Secretary may require to carry out the objectives of this section.
p.000333: (2) The Secretary shall take such action as may be appropriate to ensure that the conditions of the written
p.000333: agreement prescribed by this subsection are adhered to.
p.000333: (c) If an individual breaches the contract entered into under section 338A or 338B by failing (for any reason)
p.000333: to begin his service obligation in accordance with an agreement entered into under sub- section (a) or to complete
p.000333: such service obligation, the Secretary may permit such individual to perform such service obligation as a
p.000333: member of the Corps.
p.000333: (d) The Secretary may pay an individual who has entered into an agreement with the Secretary under subsection
p.000333: (a) an amount to cover all or part of the individual’s expenses reasonably incurred in transporting himself, his
p.000333: family, and his possessions to the loca- tion of his private clinical practice.
p.000333: (e) Upon the expiration of the written agreement under sub- section (a), the Secretary may (notwithstanding
p.000333: any other provision of law) sell to the individual who has entered into an agreement with the Secretary
p.000333: under subsection (a), equipment and other prop- erty of the United States utilized by such individual in
p.000333: providing health services. Sales made under this subsection shall be made at the fair market value (as determined
p.000333: by the Secretary) of the equipment or such other property, except that the Secretary may make such sales
p.000333: for a lesser value to the individual if he deter- mines that the individual is financially unable to pay the
p.000333: full mar- ket value.
p.000333: (f) The Secretary may, out of appropriations authorized under section 338, pay to individuals
p.000333: participating in private practice
p.000333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000333: Sec. 338E PUBLIC HEALTH SERVICE ACT 334
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p.000333: under this section the cost of such individual’s malpractice insur- ance and the lesser of—
p.000333: (1)(A) $10,000 in the first year of obligated service;
p.000333: (B) $7,500 in the second year of obligated service;
p.000333: (C) $5,000 in the third year of obligated service; and
p.000333: (D) $2,500 in the fourth year of obligated service; or
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p.000351: ensure the prompt provision of a broad range of high-qual- ity, accessible services, including, as appropriate,
p.000351: primary, secondary, and tertiary services, as well as substance abuse treatment and mental health
p.000351: services in a manner that assures continuity of care in the community or geo- graphic area;
p.000351: (F) provides evidence of community involvement in the development, implementation, and direction of the pro- gram
p.000351: that the entity proposes to operate;
p.000351: (G) demonstrates the consortium’s ability to ensure that individuals participating in the program are
p.000351: enrolled in public insurance programs for which the individuals are eligible or know of private insurance
p.000351: programs where available;
p.000351: (H) presents a plan for leveraging other sources of rev- enue, which may include State and local sources and
p.000351: pri- vate grant funds, and integrating current and proposed new funding sources in a way to assure long-term
p.000351: sustain- ability of the program;
p.000351: (I) describes a plan for evaluation of the activities car- ried out under the grant, including measurement
p.000351: of progress toward the goals and objectives of the program and the use of evaluation findings to improve
p.000351: program per- formance;
p.000351: (J) demonstrates fiscal responsibility through the use of appropriate accounting procedures and
p.000351: appropriate management systems;
p.000351: (K) demonstrates the consortium’s commitment to serve the community without regard to the ability of an in-
p.000351: dividual or family to pay by arranging for or providing free or reduced charge care for the poor; and
p.000351: (L) includes such other information as the Secretary may prescribe.
p.000351: (c) LIMITATIONS.—
p.000351: (1) NUMBER OF AWARDS.—
p.000351: (A) IN GENERAL.—For each of fiscal years 2003, 2004, 2005, and 2006, the Secretary may not make more than 35
p.000351: new awards under subsection (a) (excluding renewals of such awards).
p.000351: (B) RULE OF CONSTRUCTION.—This paragraph shall not be construed to affect awards made before fiscal year 2003.
p.000351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000353: 353
p.000353: PUBLIC HEALTH SERVICE ACT
p.000353: Sec. 340
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p.000353: (2) IN GENERAL.—An eligible entity may not receive a grant under this section (including with respect to
p.000353: any such grant made before fiscal year 2003) for more than 3 consecu- tive fiscal years, except that
p.000353: such entity may receive such a grant award for not more than 1 additional fiscal year if—
p.000353: (A) the eligible entity submits to the Secretary a re- quest for a grant for such an additional fiscal year;
p.000353: (B) the Secretary determines that extraordinary cir- cumstances (as defined in paragraph (3)) justify the grant-
p.000353: ing of such request; and
p.000353: (C) the Secretary determines that granting such re- quest is necessary to further the objectives
p.000353: described in subsection (a).
p.000353: (3) EXTRAORDINARY CIRCUMSTANCES.—
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p.000359: drug (for a unit of the dosage form and strength in- volved) during the preceding calendar quarter; divided
p.000359: by
p.000359: (ii) the average manufacturer price for such a unit of the drug during such quarter.
p.000359: (B) OVER THE COUNTER DRUGS.—
p.000359: (i) IN GENERAL.—For purposes of subparagraph (A), in the case of over the counter drugs, the ‘‘rebate percentage’’
p.000359: shall be determined as if the rebate re- quired under section 1927(c) of the Social Security Act is based on
p.000359: the applicable percentage provided under section 1927(c)(3) of such Act.
p.000359: (ii) DEFINITION.—The term ‘‘over the counter drug’’ means a drug that may be sold without a pre-
p.000359: scription and which is prescribed by a physician (or other persons authorized to prescribe such drug under
p.000359: State law).
p.000359: (3) DRUGS PROVIDED UNDER STATE MEDICAID PLANS.— Drugs described in this paragraph are drugs purchased
p.000359: by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the
p.000359: Social Secu- rity Act.
p.000359: (4) COVERED ENTITY DEFINED.—In this section, the term ‘‘covered entity’’ means an entity that meets the
p.000359: requirements described in paragraph (5) and is one of the following:
p.000359: (A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act).
p.000359: (B) An entity receiving a grant under section 340A 46.
p.000359: (C) A family planning project receiving a grant or con- tract under section 1001.
p.000359: (D) An entity receiving a grant under subpart II of part C of title XXVI (relating to categorical grants for
p.000359: out- patient early intervention services for HIV disease).
p.000359: (E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under title XXVI.
p.000359: (F) A black lung clinic receiving funds under section 427(a) of the Black Lung Benefits Act.
p.000359: (G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the So-
p.000359: cial Security Act.
p.000359: (H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
p.000359: (I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act.
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p.000359: 46 See footnote on preceding page. See also footnote for section 217(a).
p.000359: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000361: PUBLIC HEALTH SERVICE ACT
p.000361: Sec. 340B
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p.000361: (J) Any entity receiving assistance under title XXVI (other than a State or unit of local government or an
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p.000369: (1) may make the information involved available to such individuals as the entity determines appropriate;
p.000369: (2) may, as appropriate, provide information under sub- section (a) on the need for self-examination of the
p.000369: breasts and on the skills for such self-examinations;
p.000369: (3) shall provide information under subsection (a) in the language and cultural context most appropriate to the
p.000369: individ- uals to whom the information is provided; and
p.000369: (4) shall refer such clients as the entities determine appro- priate for breast and cervical cancer screening,
p.000369: treatment, or other appropriate services.
p.000369: (c) RELEVANT ENTITIES.—The entities specified in this sub- section are the following:
p.000369: (1) Entities receiving assistance under section 317F (relat- ing to tuberculosis) 53.
p.000369: (2) Entities receiving assistance under section 318 (relat- ing to sexually transmitted diseases).
p.000369: (3) Migrant health centers receiving assistance under sec- tion 329 54.
p.000369: (4) Community health centers receiving assistance under section 330 54.
p.000369: (5) Entities receiving assistance under section 330(h) (re- lating to homeless individuals).
p.000369: (6) Entities receiving assistance under section 340A 54 (re- lating to health services for residents of public
p.000369: housing).
p.000369: (7) Entities providing services with assistance under title V or title XIX.
p.000369: (8) Entities receiving assistance under section 1001 (relat- ing to family planning).
p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
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p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.000369: Subpart IX—Support of Graduate Medical Education Programs in Children’s Hospitals
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p.000371: (B) ANNUAL REPORT.—The report required under this subparagraph for a children’s hospital for a fiscal
p.000371: year is a report that includes (in a form and manner specified by the Secretary) the following information for
p.000371: the residency academic year completed immediately prior to such fiscal year:
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p.000371: (i) The types of resident training programs that the hospital provided for residents described in sub-
p.000371: paragraph (C), such as general pediatrics, internal medicine/pediatrics, and pediatric subspecialties, in-
p.000371: cluding both medical subspecialties certified by the American Board of Pediatrics (such as pediatric gas-
p.000371: troenterology) and non-medical subspecialties ap- proved by other medical certification boards (such
p.000371: as pediatric surgery).
p.000371: (ii) The number of training positions for residents described in subparagraph (C), the number of such po- sitions
p.000371: recruited to fill, and the number of such posi- tions filled.
p.000371: (iii) The types of training that the hospital pro- vided for residents described in subparagraph (C) re-
p.000371: lated to the health care needs of different populations, such as children who are underserved for reasons of
p.000371: family income or geographic location, including rural and urban areas.
p.000371: (iv) The changes in residency training for resi- dents described in subparagraph (C) which the hos- pital
p.000371: has made during such residency academic year (except that the first report submitted by the hospital under this
p.000371: subparagraph shall be for such changes since the first year in which the hospital received pay- ment under this
p.000371: section), including—
p.000371: (I) changes in curricula, training experiences, and types of training programs, and benefits that have
p.000371: resulted from such changes; and
p.000371: (II) changes for purposes of training the resi- dents in the measurement and improvement of the quality
p.000371: and safety of patient care.
p.000371: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000457: (3) In order to ensure the continuity of the Advisory Coun- cil, the Advisory Council shall be appointed so
p.000457: that each year
p.000457: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000459: PUBLIC HEALTH SERVICE ACT
p.000459: Sec. 379
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p.000459: the terms of approximately one-third of the members of the Advisory Council expire.
p.000459: (4) The membership of the Advisory Council—
p.000459: (A) shall include as voting members a balanced num- ber of representatives including representatives of marrow
p.000459: donor centers and marrow transplant centers, representa- tives of cord blood banks and participating
p.000459: birthing hos- pitals, recipients of a bone marrow transplant, recipients of a cord blood transplant, persons
p.000459: who require such trans- plants, family members of such a recipient or family mem- bers of a patient who has
p.000459: requested the assistance of the Program in searching for an unrelated donor of bone mar- row or cord blood,
p.000459: persons with expertise in bone marrow and cord blood transplantation, persons with expertise in typing,
p.000459: matching, and transplant outcome data analysis, persons with expertise in the social sciences, basic sci-
p.000459: entists with expertise in the biology of adult stem cells, and members of the general public; and
p.000459: (B) shall include as nonvoting members representa- tives from the Department of Defense Marrow Donor Re-
p.000459: cruitment and Research Program operated by the Depart- ment of the Navy, the Division of Transplantation
p.000459: of the Health Resources and Services Administration, the Food and Drug Administration, and the National
p.000459: Institutes of Health.
p.000459: (5) Members of the Advisory Council shall be chosen so as to ensure objectivity and balance and reduce the
p.000459: potential for conflicts of interest. The Secretary shall establish bylaws and procedures—
p.000459: (A) to prohibit any member of the Advisory Council who has an employment, governance, or financial
p.000459: affili- ation with a donor center, recruitment organization, trans- plant center, or cord blood bank from participating
p.000459: in any decision that materially affects the center, recruitment or- ganization, transplant center, or cord blood bank;
p.000459: and
p.000459: (B) to limit the number of members of the Advisory Council with any such affiliation.
p.000459: (6) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall submit
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p.000465: for popu- lations that are identified under paragraph (1).
p.000465: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000465: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000465: the public regarding cord blood transplants from donors as a treatment option.
p.000465: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000465: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000465: subsection (d)(2).
p.000465: (h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE MARROW AND CORD BLOOD.—
p.000465: (1) IN GENERAL.—The Secretary shall establish and main- tain, through a contract or other means
p.000465: determined appro- priate by the Secretary, an office of patient advocacy (in this subsection referred to as
p.000465: the ‘‘Office’’).
p.000465: (2) GENERAL FUNCTIONS.—The Office shall meet the fol- lowing requirements:
p.000465: (A) The Office shall be headed by a director.
p.000465: (B) The Office shall be staffed by individuals with ex- pertise in bone marrow and cord blood therapy covered
p.000465: under the Program.
p.000465: (C) The Office shall operate a system for patient advo- cacy, which shall be separate from mechanisms for donor
p.000465: advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to
p.000465: conduct, a search for a bone marrow donor or cord blood unit.
p.000465: (D) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the
p.000465: patient (or family members, physicians, or other individ- uals acting on behalf of the patient) individualized
p.000465: services with respect to efficiently utilizing the system under para- graphs (1) and (2) of subsection (d) to
p.000465: conduct an ongoing search for a bone marrow donor or cord blood unit and as- sist with information regarding third
p.000465: party payor matters.
p.000465: (E) In carrying out subparagraph (D), the Office shall monitor the system under paragraphs (1) and (2) of sub-
p.000465: section (d) to determine whether the search needs of the patient involved are being met, including with
p.000465: respect to the following:
p.000465: (i) Periodically providing to the patient (or an in- dividual acting on behalf of the patient)
p.000465: information regarding bone marrow donors or cord blood units that are suitably matched to the patient, and other
p.000465: infor-
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000467: PUBLIC HEALTH SERVICE ACT
p.000467: Sec. 379
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p.000467: mation regarding the progress being made in the search.
p.000467: (ii) Informing the patient (or such other indi- vidual) if the search has been interrupted or
p.000467: discon- tinued.
p.000467: (iii) Identifying and resolving problems in the search, to the extent practicable.
p.000467: (F) The Office shall ensure that the following data are made available to patients:
p.000467: (i) The resources available through the Program.
p.000467: (ii) A comparison of transplant centers regarding search and other costs that prior to transplantation are
p.000467: charged to patients by transplant centers.
p.000467: (iii) The post-transplant outcomes for individual transplant centers.
p.000467: (iv) Information concerning issues that patients may face after a transplant.
p.000467: (v) Such other information as the Program deter- mines to be appropriate.
p.000467: (G) The Office shall conduct surveys of patients (or family members, physicians, or other individuals acting on
p.000467: behalf of patients) to determine the extent of satisfaction with the system for patient advocacy
p.000467: under this sub- section, and to identify ways in which the system can be improved to best meet the needs
p.000467: of patients.
p.000467: (3) CASE MANAGEMENT.—
p.000467: (A) IN GENERAL.—In serving as an advocate for a pa- tient under paragraph (2), the Office shall provide
p.000467: individ- ualized case management services directly to the patient (or family members, physicians, or other
p.000467: individuals acting on behalf of the patient), including—
p.000467: (i) individualized case assessment; and
p.000467: (ii) the functions described in paragraph (2)(D) (relating to progress in the search process).
p.000467: (B) POSTSEARCH FUNCTIONS.—In addition to the case management services described in paragraph (1) for pa-
p.000467: tients, the Office shall, on behalf of patients who have completed the search for a bone marrow donor
p.000467: or cord blood unit, provide information and education on the proc- ess of receiving a transplant, including the
p.000467: post-transplant process.
p.000467: (i) COMMENT PROCEDURES.—The Secretary shall establish and provide information to the public on procedures
p.000467: under which the Secretary shall receive and consider comments from interested per- sons relating to the manner
p.000467: in which the Program is carrying out the duties of the Program. The Secretary may promulgate regula-
p.000467: tions under this section.
p.000467: (j) CONSULTATION.—In developing policies affecting the Pro- gram, the Secretary shall consult with the
p.000467: Advisory Council, the Department of Defense Marrow Donor Recruitment and Research Program operated by the
p.000467: Department of the Navy, and the board of directors of each entity awarded a contract under this
p.000467: section.
p.000467: (k) CONTRACTS.—
p.000467: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000487: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000487: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000487: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: Sec. 399 PUBLIC HEALTH SERVICE ACT 490
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p.000489: (A) the stated objective of the project to be operated with the grant, as determined after considering
p.000489: identified gaps in the current service delivery system; and
p.000489: (B) the nature of the needs of the family to be served, as determined at the initial assessment of the family that is
p.000489: conducted by the case manager, and through follow-up contacts by other providers of home visiting services.
p.000489: (4) FAMILY SERVICE PLAN.—A case manager, in consulta- tion with a team established in accordance with paragraph
p.000489: (5) for the family involved, shall develop a plan for the family fol- lowing the initial visit to the home of
p.000489: the family. Such plan shall reflect—
p.000489: (A) an assessment of the health and related social service needs of the family;
p.000489: (B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
p.000489: (C) the frequency with which such services are to be provided to the family;
p.000489: (D) ongoing revisions made as the needs of family members change; and
p.000489: (E) the continuing voluntary participation of the fam- ily in the plan.
p.000489: (5) HOME VISITING SERVICES TEAM.—The team to be con- sulted under paragraph (4) on behalf of a family shall
p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
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p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: 493
p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
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p.000493: January 30, 2020
p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
p.000493: reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106 of Public Law 106–310 (114
p.000493: Stat. 1175) attempts to make various amendments to section 399D, but the amendments cannot be executed because section
p.000493: 399D was redesignated as section 399A by section 502(1) of such Public Law (114 Stat. 1115). (Section 399D
p.000493: now relates to technical assistance in operations of Statewide cancer registries.)
p.000493: Further, section 3106(m) of the Public Law (114 Stat. 1179) attempts to transfer section 399D to title V of this Act as
p.000493: a section 519, but this transfer has not been executed because it applied to section 399D ‘‘as amended by this
p.000493: section’’ (section 3106), and no amendments described in section 3106 have been made to section 399D.
p.000493: As a conforming amendment, section 3106(n) of the Public Law provided that title III of this Act ‘‘is amended by
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p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
p.000495: (4) Therapeutic intervention services for children, includ- ing provision of therapeutic child care.
p.000495: (5) Preventive counseling services.
p.000495: (6) Counseling related to the witnessing of chronic vio- lence.
p.000495: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000495: (A) education and special education programs;
p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
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p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
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p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: PUBLIC HEALTH SERVICE ACT
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
p.000501: (ii) the entity will identify children who may be eli- gible for medical assistance under a State program under
p.000501: title XIX or XXI of the Social Security Act.
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p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
p.000501: the family member involved:
p.000501: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000501: professional, or by a trained worker from the community who is supervised by a profes- sional, or by an
p.000501: entity, where the professional or entity provides assurances that the professional or entity is licensed or certified
p.000501: by the State if required and is complying with applicable licen- sure or certification requirements:
p.000501: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services
p.000501: and services for children of substance abusers.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
p.000503:
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p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
...

p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: 507
p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
...

p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
p.000507: Control, may make grants to States, or may make grants or enter into con- tracts with academic or
p.000507: nonprofit organizations designated by the State to operate the State’s cancer registry in lieu of mak- ing a grant
p.000507: directly to the State, to support the operation of population-based, statewide registries to collect, for each
p.000507: condi- tion specified in paragraph (2)(A), data concerning—
p.000507: (A) demographic information about each case of can-
p.000507:
p.000507:
p.000507: January 30, 2020
p.000507: cer;
p.000507:
p.000507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: 525
p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
p.000525: families, including patient education regarding asthma management, family education on asthma
p.000525: management, and the distribution of materials, including displays and videos, to reinforce concepts
p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
p.000525: or high rate of hos- pitalization or emergency room visits for asthma (relative to the average
p.000525: asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate
p.000525: a high prevalence of childhood asthma or high asthma-related mortality may include data from Fed- eral, State, or
p.000525: local vital statistics, claims data under title XIX or XXI of the Social Security Act, other public health
p.000525: statistics or surveys, or other data that the Secretary, in consultation with the Director of the
p.000525: Centers for Disease Control and Prevention, deems appropriate.
...

p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: 529
p.000529: PUBLIC HEALTH SERVICE ACT
p.000529: Sec. 399M
p.000529:
p.000529:
p.000529:
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p.000529: January 30, 2020
p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
p.000529: (including medical homes for children), and in programs mandated by part C of the Individuals with Disabilities
p.000529: Education Act, which offer programs specifically designed to meet the unique language and communication
p.000529: needs of deaf and hard-of-hearing children.
p.000529: (B) Information provided to families should be accu- rate, comprehensive, up-to-date, and evidence-based,
p.000529: as appropriate, to allow families to make important decisions for their children in a timely manner, including
p.000529: decisions with respect to the full range of assistive hearing tech- nologies and communications modalities, as
p.000529: appropriate.
p.000529: (C) Programs and systems under this paragraph shall offer mechanisms that foster family-to-family and deaf and
p.000529: hard-of-hearing consumer-to-family supports.
p.000529: (2) To continue to provide technical support to States, through one or more technical resource centers, to
p.000529: assist in fur- ther developing and enhancing State early hearing detection and intervention programs.
p.000529: (3) To identify or develop efficient models (educational and medical) to ensure that children who are identified
p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000529:
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p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000531:
p.000531:
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000531:
p.000531:
p.000531:
p.000531:
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p.000531:
p.000531: January 30, 2020
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p.000541: do- mestic and sexual violence;
p.000541: (ii) the development, expansion, and implementa- tion of sexual assault forensic medical examination or sexual
p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
p.000541: dress issues of confidentiality and patient safety and com- ply with applicable confidentiality and nondisclosure
p.000541: re- quirements under section 40002(b)(2) of the Violence Against Women Act of 1994 and the Family Violence
p.000541: Pre- vention and Services Act, and that faculty and staff associ- ated with delivering educational components
p.000541: are fully trained in procedures that will protect the immediate and ongoing security and confidentiality
p.000541: of the patients, pa- tient records, and staff. Such grantees shall consult enti- ties with demonstrated
p.000541: expertise in the confidentiality and safety needs of victims of domestic violence, dating vio- lence, sexual
p.000541: assault, and stalking on the development and adequacy of confidentially and security procedures, and provide
p.000541: documentation of such consultation.
p.000541: (B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.— Grantees under this section shall provide to patients
p.000541: ad- vance notice about any circumstances under which infor- mation may be disclosed, such as mandatory
p.000541: reporting laws, and shall give patients the option to receive informa- tion and referrals without affirmatively
p.000541: disclosing abuse.
p.000541: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee shall use not more than 10 percent of the amounts
p.000541: received under a grant under this section for administrative expenses.
p.000541: (3) APPLICATION.—
p.000541: (A) PREFERENCE.—In selecting grant recipients under this section, the Secretary shall give preference to
p.000541: appli- cants based on the strength of their evaluation strategies, with priority given to outcome based evaluations.
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
...

p.000545: purpose of carrying out this section.
p.000545: SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
p.000545: (a) ESTABLISHMENT.—
p.000545: (1) IN GENERAL.—Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary,
p.000545: act- ing through the Director of the Centers for Disease Control and Prevention, may, if scientifically
p.000545: advisable—
p.000545: (A) develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as
p.000545: ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some
p.000545: cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the
p.000545: United States; and
p.000545: (B) establish a national registry for the collection and storage of such data to develop a population-based
p.000545: registry of cases in the United States of ALS and other motor neu- ron disorders that can be confused with ALS,
p.000545: misdiagnosed as ALS, and in some cases progress to ALS.
p.000545: (2) PURPOSE.—It is the purpose of the registry established under paragraph (1)(B) to—
p.000545: (A) better describe the incidence and prevalence of ALS in the United States;
p.000545: (B) examine appropriate factors, such as environ- mental and occupational, that may be associated
p.000545: with the disease;
p.000545: (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history
p.000545: of indi- viduals who are diagnosed with the disease) associated with the disease;
p.000545: (D) better examine the connection between ALS and other motor neuron disorders that can be confused with
p.000545: ALS, misdiagnosed as ALS, and in some cases progress to ALS; and
p.000545: (E) other matters as recommended by the Advisory Committee established under subsection (b).
p.000545: (b) ADVISORY COMMITTEE.—
p.000545: (1) ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the
p.000545: Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a
p.000545: committee to be known as the Ad- visory Committee on the National ALS Registry (referred to in
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000547: PUBLIC HEALTH SERVICE ACT
p.000547: Sec. 399S
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p.000547: January 30, 2020
p.000547: this section as the ‘‘Advisory Committee’’). The Advisory Com- mittee shall be composed of not more than
p.000547: 27 members to be appointed by the Secretary, acting through the Centers for Dis- ease Control and Prevention, of
p.000547: which—
p.000547: (A) two-thirds of such members shall represent gov- ernmental agencies—
p.000547: (i) including at least one member representing—
p.000547: (I) the National Institutes of Health, to in- clude, upon the recommendation of the Director of the National
p.000547: Institutes of Health, representatives from the National Institute of Neurological Dis- orders and Stroke
p.000547: and the National Institute of Environmental Health Sciences;
p.000547: (II) the Department of Veterans Affairs;
p.000547: (III) the Agency for Toxic Substances and Dis- ease Registry; and
p.000547: (IV) the Centers for Disease Control and Pre- vention; and
p.000547: (ii) of which at least one such member shall be a clinician with expertise on ALS and related
p.000547: diseases, an epidemiologist with experience in data registries, a statistician, an ethicist, and a privacy expert
p.000547: (relating to the privacy regulations under the Health Insurance Portability and Accountability Act of 1996); and
p.000547: (B) one-third of such members shall be public mem- bers, including at least one member representing—
p.000547: (i) national and voluntary health associations;
p.000547: (ii) patients with ALS or their family members;
p.000547: (iii) clinicians with expertise on ALS and related diseases;
p.000547: (iv) epidemiologists with experience in data reg- istries;
p.000547: (v) geneticists or experts in genetics who have ex- perience with the genetics of ALS or other neurological diseases
p.000547: and
p.000547: (vi) other individuals with an interest in devel- oping and maintaining the National ALS Registry.
p.000547: (2) DUTIES.—The Advisory Committee may review infor- mation and make recommendations to the Secretary
p.000547: con- cerning—
p.000547: (A) the development and maintenance of the National ALS Registry;
p.000547: (B) the type of information to be collected and stored in the Registry;
p.000547: (C) the manner in which such data is to be collected;
p.000547: (D) the use and availability of such data including guidelines for such use; and
p.000547: (E) the collection of information about diseases and disorders that primarily affect motor neurons that are con-
p.000547: sidered essential to furthering the study and cure of ALS.
p.000547: (3) REPORT.—Not later than 270 days after the date on which the Advisory Committee is established, the
p.000547: Advisory Committee may submit a report to the Secretary concerning the review conducted under paragraph
p.000547: (2) that contains the
p.000547: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000547: Sec. 399S PUBLIC HEALTH SERVICE ACT 548
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p.000549: (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and
p.000549: (2) incorporate information obtained through such activi- ties into an integrated surveillance system, which may
p.000549: consist of or include a registry, to be known as the National Neuro- logical Conditions Surveillance System.
p.000549: (b) RESEARCH.—The Secretary shall ensure that the National Neurological Conditions Surveillance System is
p.000549: designed in a man- ner that facilitates further research on neurological diseases.
p.000549: (c) CONTENT.—In carrying out subsection (a), the Secretary—
p.000549: (1) shall provide for the collection and storage of informa- tion on the incidence and prevalence of
p.000549: neurological diseases in the United States;
p.000549: (2) to the extent practicable, shall provide for the collection and storage of other available information on
p.000549: neurological dis- eases, including information related to persons living with neu- rological diseases who choose to
p.000549: participate, such as—
p.000549: (A) demographics, such as age, race, ethnicity, sex, ge- ographic location, family history, and other information, as
p.000549: appropriate;
p.000549: (B) risk factors that may be associated with neuro- logical diseases, such as genetic and environmental
p.000549: risk factors and other information, as appropriate; and
p.000549: (C) diagnosis and progression markers;
p.000549: (3) may provide for the collection and storage of informa- tion relevant to analysis on neurological
p.000549: diseases, such as in- formation concerning—
p.000549: (A) the natural history of the diseases;
p.000549: (B) the prevention of the diseases;
p.000549: (C) the detection, management, and treatment ap- proaches for the diseases; and
p.000549: (D) the development of outcomes measures;
p.000549: (4) may address issues identified during the consultation process under subsection (d); and
p.000549: (5) initially may address a limited number of neurological diseases.
p.000549: (d) CONSULTATION.—In carrying out this section, the Secretary shall consult with individuals with appropriate
p.000549: expertise, which may include—
p.000549: (1) epidemiologists with experience in disease surveillance or registries;
p.000549: (2) representatives of national voluntary health associa- tions that—
p.000549: (A) focus on neurological diseases; and
p.000549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000549: Sec. 399S–1 PUBLIC HEALTH SERVICE ACT 550
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p.000551: (k) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000551: $5,000,000 for each of fiscal years 2018 through 2022.
p.000551: SEC. 399T. ø280g–8¿ SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR
p.000551: POSTNATALLY DIAGNOSED CONDITIONS.
p.000551: (a) DEFINITIONS.—In this section:
p.000551: (1) DOWN SYNDROME.—The term ‘‘Down syndrome’’ refers to a chromosomal disorder caused by an error in
p.000551: cell division that results in the presence of an extra whole or partial copy of chromosome 21.
p.000551: (2) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any person or entity required by State or
p.000551: Federal law or regulation to be licensed, registered, or certified to pro- vide health care services, and who is so
p.000551: licensed, registered, or certified.
p.000551: (3) POSTNATALLY DIAGNOSED CONDITION.—The term ‘‘postnatally diagnosed condition’’ means any health
p.000551: condition identified during the 12-month period beginning at birth.
p.000551: (4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘pre- natally diagnosed condition’’ means any fetal health
p.000551: condition identified by prenatal genetic testing or prenatal screening pro- cedures.
p.000551: (5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diag- nostic or screening tests offered to pregnant women
p.000551: seeking routine prenatal care that are administered on a required or recommended basis by a health care
p.000551: provider based on medical history, family background, ethnic background, previous test results, or other risk
p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
p.000551:
p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
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p.000553: January 30, 2020
p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
p.000553: organizations delivering population-based services, including primary care professionals, health care
p.000553: systems, professional societies, employers, community organizations, non-profit organizations, schools,
p.000553: governmental pub- lic health agencies, Indian tribes, tribal organizations and urban Indian organizations,
p.000553: medical groups, Congress and other policy- makers. Community preventive services include any policies, pro-
p.000553: grams, processes or activities designed to affect or otherwise affect- ing health at the population level.
p.000553: (b) DUTIES.—The duties of the Task Force shall include—
p.000553: (1) the development of additional topic areas for new rec- ommendations and interventions related to
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p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
p.000557: (B) may include entities such as hospital associations, primary care practice-based research networks, health pro-
p.000557: fessional societies, State primary care associations, State licensing boards, organizations with a contract
p.000557: with the Secretary under section 1153 of the Social Security Act, consumer groups, and other appropriate
p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
p.000557: (1) HUB ACTIVITIES.—Hubs established under a grant under subsection (b) shall—
p.000557: (A) submit to the Secretary a plan to coordinate func- tions with quality improvement organizations and area
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p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: Sec. 399V–2 PUBLIC HEALTH SERVICE ACT 560
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p.000559: (b) ACTIVITIES.—
p.000559: (1) IN GENERAL.—The Secretary shall carry out activities, including, as appropriate, through a national cohort
p.000559: study and a nationally-representative, population-based surveillance sys- tem, to improve the understanding of the
p.000559: epidemiology of con- genital heart disease in all age groups, with particular atten- tion to—
p.000559: (A) the incidence and prevalence of congenital heart disease in the United States;
p.000559: (B) causation and risk factors associated with, and natural history of, congenital heart disease;
p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
p.000559: members, and health care providers, on topics such as the prevalence of such disease, the effect of
p.000559: such disease on individuals of all ages, and the importance of long-term, special- ized care for individuals with such
p.000559: disease.
p.000559: (d) PUBLIC ACCESS.—The Secretary shall ensure that, subject to subsection (e), information collected under
p.000559: this section is made available, as appropriate, to the public, including researchers.
p.000559: (e) PATIENT PRIVACY.—The Secretary shall ensure that the data and information collected under this section
p.000559: are made avail- able in a manner that, at a minimum, protects personal privacy to the extent required by applicable
p.000559: Federal and State law.
p.000559: (f) ELIGIBILITY FOR GRANTS.—To be eligible to receive a grant under subsection (a)(3), an entity shall—
p.000559: (1) be a public or private nonprofit entity with specialized experience in congenital heart disease; and
p.000559: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000559: Sec- retary may require.
p.000559: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000559: $10,000,000 for each of fiscal years 2020 through 2024.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000561: PUBLIC HEALTH SERVICE ACT
p.000561: Sec. 399V–4
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p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
p.000579: autism spectrum disorder or other developmental dis- abilities), and evidence-based interventions.
p.000579: (B) REQUIREMENTS OF AGENCY.—In designating the lead agency under subparagraph (A)(i), the Governor
p.000579: shall—
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p.000579: January 30, 2020
p.000579: (i) select an agency that has demonstrated experi- ence and expertise in—
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: PUBLIC HEALTH SERVICE ACT
p.000581: Sec. 399BB
p.000581:
p.000581: (I) autism spectrum disorder and other devel- opmental disability issues; and
p.000581: (II) developing, implementing, conducting, and administering programs and delivering edu- cation,
p.000581: information, and referral services (includ- ing technology-based curriculum-development services) to
p.000581: individuals with autism spectrum dis- order and developmental disabilities and their family members,
p.000581: guardians, advocates or author- ized representatives, providers, and other appro- priate individuals locally
p.000581: and across the State; and
p.000581: (ii) consider input from individuals with autism spectrum disorder and developmental disabilities and their
p.000581: family members, guardians, advocates or author- ized representatives, providers, and other appropriate
p.000581: individuals.
p.000581: (C) INFORMATION.—Information under subparagraph (A)(ii) shall be provided through—
p.000581: (i) toll-free telephone numbers;
p.000581: (ii) Internet websites;
p.000581: (iii) mailings; or
p.000581: (iv) such other means as the Governor may re- quire.
p.000581: (d) TOOLS.—
p.000581: (1) IN GENERAL.—To promote the use of valid and reliable screening tools for autism spectrum disorder and other
p.000581: devel- opmental disabilities, the Secretary shall develop a curriculum for continuing education to assist
p.000581: individuals in recognizing the need for valid and reliable screening tools and the use of such tools.
p.000581: (2) COLLECTION, STORAGE, COORDINATION, AND AVAIL- ABILITY.—The Secretary, in collaboration with the
p.000581: Secretary of Education, shall provide for the collection, storage, coordina- tion, and public availability of
p.000581: tools described in paragraph (1), educational materials and other products that are used by the Federal programs
p.000581: referred to in subsection (c)(1)(A), as well as—
p.000581:
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p.000581:
p.000581:
p.000581: January 30, 2020
p.000581: (A) programs authorized under the Developmental Disabilities Assistance and Bill of Rights Act of 2000;
p.000581: (B) early intervention programs or interagency coordi- nating councils authorized under part C of the Individuals with
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p.000581:
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p.000581: January 30, 2020
p.000581:
p.000581: interdisciplinary training opportunities or opportunities to in- crease the number of sites able to diagnose or
p.000581: rule out individ- uals with autism spectrum disorder or other developmental disabilities across their lifespan
p.000581: and ensure that—
p.000581: (A) competitive grants or cooperative agreements are awarded to public or nonprofit agencies, including
p.000581: institu- tions of higher education, to expand existing or develop new maternal and child health
p.000581: interdisciplinary leadership education in neurodevelopmental and related disabilities programs (similar to the
p.000581: programs developed under section 501(a)(2) of the Social Security Act) in States that do not have such a
p.000581: program;
p.000581: (B) trainees under such training programs—
p.000581: (i) receive an appropriate balance of academic, clinical, and community opportunities;
p.000581: (ii) are culturally competent;
p.000581: (iii) are ethnically diverse;
p.000581: (iv) demonstrate a capacity to evaluate, diagnose or rule out, develop, and provide evidence-based inter-
p.000581: ventions to individuals with autism spectrum disorder and other developmental disabilities across their life-
p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
p.000581: (ii) an urban or rural area designated by the Sec- retary as an area with a shortage of personal health
p.000581: services (as described in section 330(b)(3)(A)).
p.000581: (3) TECHNICAL ASSISTANCE.—The Secretary may award one or more grants under this section to provide
p.000581: technical assist- ance to the network of interdisciplinary training programs.
p.000581: (4) BEST PRACTICES.—The Secretary shall promote re- search into additional valid and reliable tools
p.000581: for shortening the time required to confirm or rule out a diagnosis of autism spectrum disorder or other
p.000581: developmental disabilities and de- tecting individuals with autism spectrum disorder or other de- velopmental
p.000581: disabilities at an earlier age.
p.000581: (f) INTERVENTION.—The Secretary shall promote research, through grants or contracts, which may include grants
...

p.000595: through the Director of the Centers for Disease Control and Prevention, shall establish an advisory
p.000595: committee to assist in creating and conducting the education campaigns under paragraph (1) and subsection (b)(1).
p.000595: (B) MEMBERSHIP.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000595: tion, shall appoint to the advisory committee under sub- paragraph (A) such members as deemed necessary to
p.000595: prop- erly advise the Secretary, and shall include organizations and individuals with expertise in breast
p.000595: cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and
p.000595: counseling, treatment, rehabilitation, palliative care, and survivorship in young women.
p.000595: (b) HEALTH CARE PROFESSIONAL EDUCATION CAMPAIGN.—The Secretary, acting through the Director of the Centers
p.000595: for Disease Control and Prevention, and in consultation with the Administrator of the Health Resources and Services
p.000595: Administration, shall conduct an education campaign among physicians and other health care professionals to
p.000595: increase awareness—
p.000595: (1) of breast health, symptoms, and early diagnosis and treatment of breast cancer in young women,
p.000595: including specific risk factors such as family history of cancer and women that may be at high risk for
p.000595: breast cancer, such as Ashkenazi Jew- ish population;
p.000595: (2) on how to provide counseling to young women about their breast health, including knowledge of their family
p.000595: cancer history and importance of providing regular clinical breast ex- aminations;
p.000595: (3) concerning the importance of discussing healthy behav- iors, and increasing awareness of services and programs
p.000595: avail- able to address overall health and wellness, and making pa- tient referrals to address tobacco
p.000595: cessation, good nutrition, and physical activity;
p.000595: (4) on when to refer patients to a health care provider with genetics expertise;
p.000595: (5) on how to provide counseling that addresses long-term survivorship and health concerns of young women
p.000595: diagnosed with breast cancer; and
p.000595: (6) on when to provide referrals to organizations and insti- tutions that provide credible health information
p.000595: and sub- stantive assistance and support to young women diagnosed with breast cancer.
p.000595: (c) PREVENTION RESEARCH ACTIVITIES.—The Secretary, acting through—
p.000595: (1) the Director of the Centers for Disease Control and Prevention, shall conduct prevention research on
p.000595: breast cancer in younger women, including—
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: PUBLIC HEALTH SERVICE ACT
p.000597: Sec. 399NN
p.000597:
p.000597: (A) behavioral, survivorship studies, and other re- search on the impact of breast cancer diagnosis
...

p.000597: (d) SUPPORT FOR YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.—
p.000597: (1) IN GENERAL.—The Secretary shall award grants to or- ganizations and institutions to provide health
p.000597: information from credible sources and substantive assistance directed to young women diagnosed with breast
p.000597: cancer and pre-neoplastic breast diseases.
p.000597: (2) PRIORITY.—In making grants under paragraph (1), the Secretary shall give priority to applicants that deal
p.000597: specifically with young women diagnosed with breast cancer and pre-neo- plastic breast disease.
p.000597: (e) NO DUPLICATION OF EFFORT.—In conducting an education campaign or other program under subsections (a),
p.000597: (b), (c), or (d), the Secretary shall avoid duplicating other existing Federal breast cancer education efforts.
p.000597: (f) MEASUREMENT; REPORTING.—The Secretary, acting through the Director of the Centers for Disease
p.000597: Control and Prevention, shall—
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p.000597: January 30, 2020
p.000597: (1) measure—
p.000597: (A) young women’s awareness regarding breast health, including knowledge of family cancer history, specific risk
p.000597: factors and early warning signs, and young women’s proactive efforts at early detection;
p.000597: (B) the number or percentage of young women uti- lizing information regarding lifestyle interventions that
p.000597: foster healthy behaviors;
p.000597: (C) the number or percentage of young women receiv- ing regular clinical breast exams; and
p.000597: (D) the number or percentage of young women who perform breast self exams, and the frequency of
p.000597: such exams, before the implementation of this section;
p.000597: (2) not less than every 3 years, measure the impact of such activities; and
p.000597: (3) submit reports to the Congress on the results of such measurements.
p.000597: (g) DEFINITION.—In this section, the term ‘‘young women’’ means women 15 to 44 years of age.
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: Sec. 401 PUBLIC HEALTH SERVICE ACT 598
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p.000725: paragraph (1), and annually thereafter, the Director of the Insti- tute shall prepare and transmit to
p.000725: the Chairman of the Council such revisions of such plan as the Director considers appropriate.
p.000725: (c) In preparing and revising the plan required by subsection (b), the Director of the Institute shall
p.000725: consult with the Chairman of the Council and the heads of agencies within the Department.
p.000725: (d) the 28 Director of the Institute may develop, or make grants to develop—
p.000725: (1) model techniques to—
p.000725: (A) promote greater independence, including enhanced independence in performing activities of daily living and
p.000725:
p.000725:
p.000725:
p.000725: January 30, 2020
p.000725: 28 So in law. See section 9 of Public Law 102–507 (106 Stat. 3287). Probably should be ‘‘The’’.
p.000725: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000725: Sec. 445D PUBLIC HEALTH SERVICE ACT 726
p.000725:
p.000725: instrumental activities of daily living, for persons with Alz- heimer’s disease and related disorders; and
p.000725: (B) prevent or reduce the severity of secondary disabil- ities, including confusional episodes, falls,
p.000725: bladder and bowel incontinence, and adverse effects of prescription and over-the-counter medications, in such
p.000725: persons; and
p.000725: (2) model curricula for health care professionals, health care paraprofessionals, and family caregivers, for
p.000725: training and application in the use of such techniques.
p.000725: (e) For purposes of this section, the term ‘‘Council on Alz- heimer’s Disease’’ means the council established
p.000725: in section 911(a) 29 of Public Law 99–660.
p.000725: DISSEMINATION
p.000725: SEC. 445D. ø285e–6¿ The Director of the Institute shall dis- seminate the results of research conducted under
p.000725: section 445C and this section to appropriate professional entities and to the public.
p.000725: CLEARINGHOUSE ON ALZHEIMER’S DISEASE
p.000725: SEC. 445E. ø285e–7¿ (a) The Director of the Institute shall es- tablish the Clearinghouse on Alzheimer’s Disease
p.000725: (hereinafter re- ferred to as the ‘‘Clearinghouse’’). The purpose of the Clearinghouse is the dissemination of
p.000725: information concerning services available for individuals with Alzheimer’s disease and related dementias and their
p.000725: families. The Clearinghouse shall—
p.000725: (1) compile, archive, and disseminate information con- cerning research, demonstration, evaluation, and
p.000725: training pro- grams and projects concerning Alzheimer’s disease and related dementias; and
p.000725: (2) annually publish a summary of the information com- piled under paragraph (1) during the preceding
p.000725: 12-month pe- riod, and make such information available upon request to ap- propriate individuals and entities,
p.000725: including educational insti- tutions, research entities, and Federal and public agencies.
p.000725: (b) The Clearinghouse may charge an appropriate fee for infor- mation provided through the toll-free telephone
p.000725: line established under subsection (a)(3). 30
...

p.000745: (1) collect and disseminate through publications and other appropriate means (including the development of
p.000745: curriculum materials), information as to, and the practical application of, the research and other activities
p.000745: under the program;
p.000745: (2) make available research facilities of the Public Health Service to appropriate public authorities, and to
p.000745: health officials and scientists engaged in special study;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
p.000745:
p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
...

p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
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p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
p.000841: (1) a summary of the manner in which individuals with co- occurring disorders are receiving treatment, including the
p.000841: most up-to-date information available regarding the number of chil- dren and adults with co-occurring mental illness
p.000841: and substance abuse disorders and the manner in which funds provided under sections 1911 and 1921 are
p.000841: being utilized, including the number of such children and adults served with such funds;
p.000841: (2) a summary of improvements necessary to ensure that individuals with co-occurring mental illness
...

p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
p.000849: consultation with the women, prepare an individualized plan for the provi- sion of services for the woman and
p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
p.000849: (A) individual, group, and family counseling, as appro- priate, regarding substance use disorders; and
p.000849: (B) follow-up services to assist the woman in pre- venting a relapse into such a disorder.
p.000849: (d) REQUIRED SUPPLEMENTAL SERVICES.—In the case of an eli- gible woman, the services referred to in subsection (a)(3)
p.000849: are as fol- lows:
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p.000849: (1) Prenatal and postpartum health care.
p.000849: (2) Referrals for necessary hospital services.
p.000849: (3) For the infants and children of the woman—
p.000849: (A) pediatric health care, including treatment for any perinatal effects of a maternal substance use disorder
p.000849: and including screenings regarding the physical and mental de- velopment of the infants and children;
p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
p.000849: (A) the applicant has the capacity to carry out a pro- gram described in subsection (a);
p.000849: (B) the plans of the applicant for such a program are consistent with the policies of such agency
p.000849: regarding the treatment of substance use disorders; and
p.000849: (C) the applicant, or any entity through which the ap- plicant will provide authorized services, meets all applica- ble
p.000849: State licensure or certification requirements regarding the provision of the services involved.
p.000849: (2) STATUS AS MEDICAID PROVIDER.—
p.000849: (A) IN GENERAL.—Subject to subparagraphs (B) and (C), the Director may make an award under subsection (a) only
p.000849: if, in the case of any authorized service that is avail- able pursuant to the State plan approved under title
p.000849: XIX of the Social Security Act for the State involved—
p.000849: (i) the applicant for the award will provide the service directly, and the applicant has entered into a
p.000849: participation agreement under the State plan and is qualified to receive payments under such plan; or
...

p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
p.000851: (3) providing such other information as the Director deter- mines to be appropriate.
p.000851: (l) REQUIREMENT OF APPLICATION.—The Director may make an award under subsection (a) only if an application for
p.000851: the award is submitted to the Director containing such agreements, and the ap- plication is in such form, is
p.000851: made in such manner, and contains such other agreements and such assurances and information as the Director
p.000851: determines to be necessary to carry out this section.
p.000851: (m) ALLOCATION OF AWARDS.—In making awards under sub- section (a), the Director shall give priority to
p.000851: an applicant that agrees to use the award for a program serving an area that is a rural area, an area
p.000851: designated under section 332 by the Secretary as a health professional shortage area, or an area
p.000851: determined by
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000853: 853
p.000853: PUBLIC HEALTH SERVICE ACT
p.000853: Sec. 508
p.000853:
p.000853: the Director to have a shortage of family-based substance use dis- order treatment options.
p.000853: (n) DURATION OF AWARD.—The period during which payments are made to an entity from an award under subsection
p.000853: (a) may not exceed 5 years. The provision of such payments shall be subject to annual approval by the Director of the
p.000853: payments and subject to the availability of appropriations for the fiscal year involved to make the payments.
p.000853: This subsection may not be construed to establish a limitation on the number of awards under such subsection
p.000853: that may be made to an entity.
p.000853: (o) EVALUATIONS; DISSEMINATION OF FINDINGS.—The Director shall, directly or through contract, provide for
p.000853: the conduct of eval- uations of programs carried out pursuant to subsection (a). The Di- rector shall disseminate to
p.000853: the States the findings made as a result of the evaluations.
p.000853: (p) REPORTS TO CONGRESS.—Not later than October 1, 1994, the Director shall submit to the Committee on
p.000853: Energy and Com- merce of the House of Representatives, and to the Committee on Labor and Human Resources
p.000853: of the Senate, a report describing pro- grams carried out pursuant to this section (other than subsection
p.000853: (r)). Every 2 years thereafter, the Director shall prepare a report describing such programs carried out
p.000853: during the preceding 2 years, and shall submit the report to the Assistant Secretary for inclusion in the biennial
p.000853: report under section 501(m). Each report under this subsection shall include a summary of any evaluations
p.000853: conducted under subsection (m) during the period with respect to which the report is prepared.
p.000853: (q) DEFINITIONS.—For purposes of this section:
p.000853: (1) The term ‘‘authorized services’’ means treatment serv- ices and supplemental services.
p.000853: (2) The term ‘‘eligible woman’’ means a woman who has been admitted to a program operated pursuant to
p.000853: subsection (a).
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p.000853: (3) The term ‘‘funding agreement’’, with respect to an award under subsection (a), means that the Director may
p.000853: make the award only if the applicant makes the agreement involved.
p.000853: (4) The term ‘‘treatment services’’ means treatment for a substance use disorder, including the counseling
p.000853: and services described in subsection (c)(2).
p.000853: (5) The term ‘‘supplemental services’’ means the services described in subsection (d).
p.000853: (r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.—
p.000853: (1) IN GENERAL.—From amounts made available under subsection (s), the Director of the Center for
p.000853: Substance Abuse Treatment shall carry out a pilot program under which com- petitive grants are made by
p.000853: the Director to State substance abuse agencies—
p.000853: (A) to enhance flexibility in the use of funds designed to support family-based services for
p.000853: pregnant and postpartum women with a primary diagnosis of a sub- stance use disorder, including opioid use
p.000853: disorders;
p.000853: (B) to help State substance abuse agencies address identified gaps in services furnished to such women
p.000853: along
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000853:
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p.000853: Sec. 508 PUBLIC HEALTH SERVICE ACT 854
p.000853:
p.000853: the continuum of care, including services provided to women in nonresidential-based settings; and
p.000853: (C) to promote a coordinated, effective, and efficient State system managed by State substance abuse
p.000853: agencies by encouraging new approaches and models of service de- livery.
p.000853: (2) REQUIREMENTS.—In carrying out the pilot program under this subsection, the Director shall—
p.000853: (A) require State substance abuse agencies to submit to the Director applications, in such form and manner and
p.000853: containing such information as specified by the Director, to be eligible to receive a grant under the program;
p.000853: (B) identify, based on such submitted applications, State substance abuse agencies that are eligible for
p.000853: such grants;
p.000853: (C) require services proposed to be furnished through such a grant to support family-based treatment and
p.000853: other services for pregnant and postpartum women with a pri- mary diagnosis of a substance use
p.000853: disorder, including opioid use disorders;
p.000853: (D) not require that services furnished through such a grant be provided solely to women that reside in facilities;
p.000853: (E) not require that grant recipients under the pro- gram make available through use of the grant all the serv-
p.000853: ices described in subsection (d); and
p.000853: (F) consider not applying the requirements described in paragraphs (1) and (2) of subsection (f) to an applicant,
p.000853: depending on the circumstances of the applicant.
p.000853: (3) REQUIRED SERVICES.—
p.000853: (A) IN GENERAL.—The Director shall specify a min- imum set of services required to be made available to eligi-
p.000853: ble women through a grant awarded under the pilot pro- gram under this subsection. Such minimum set of
p.000853: serv- ices—
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p.000853: (i) shall include the services requirements de- scribed in subsection (c) and be based on the rec-
p.000853: ommendations submitted under subparagraph (B); and
p.000853: (ii) may be selected from among the services de- scribed in subsection (d) and include other services as
p.000853: appropriate.
...

p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
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p.000875: (15) conduct surveys with respect to mental health, such as the National Reporting Program;
p.000875: (16) assist States in improving their mental health data collection; and
p.000875: (17) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000875: of grantees after such grants are awarded.
p.000875: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000875: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000875: SEC. 520A. ø290bb–32¿ PRIORITY MENTAL HEALTH NEEDS OF RE- GIONAL AND NATIONAL SIGNIFICANCE.
p.000875: (a) PROJECTS.—The Secretary shall address priority mental health needs of regional and national
p.000875: significance (as determined under subsection (b)) through the provision of or through assist- ance for—
p.000875: (1) knowledge development and application projects for prevention, treatment, and rehabilitation, and the
p.000875: conduct or support of evaluations of such projects;
p.000875: (2) training and technical assistance programs;
p.000875: (3) targeted capacity response programs; and
p.000875: (4) systems change grants including statewide family net- work grants and client-oriented and consumer run
p.000875: self-help ac- tivities, which may include technical assistance centers.
p.000875: The Secretary may carry out the activities described in this sub- section directly or through grants,
p.000875: contracts, or cooperative agree- ments with States, political subdivisions of States, Indian tribes or tribal
p.000875: organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education
p.000875: Assistance Act), health facilities, or programs operated by or in accordance with a contract or grant with the Indian
p.000875: Health Service, or, other public or private nonprofit entities.
p.000875: (b) PRIORITY MENTAL HEALTH NEEDS.—
p.000875: (1) DETERMINATION OF NEEDS.—Priority mental health needs of regional and national significance shall be
p.000875: determined by the Secretary in consultation with States and other inter- ested groups. The Secretary shall
p.000875: meet with the States and in- terested groups on an annual basis to discuss program prior- ities.
p.000875: (2) SPECIAL CONSIDERATION.—In developing program prior- ities described in paragraph (1), the Secretary shall
p.000875: give spe- cial consideration to promoting the integration of mental health services into primary health
p.000875: care systems.
p.000875: (c) REQUIREMENTS.—
p.000875: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000875: infor- mation and application requirements determined appropriate by the Secretary.
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p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
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p.000885: receiving a grant or cooperative agreement under subsection (a) shall prepare and submit an application to
p.000885: the Secretary at such time, in such manner, and containing such infor- mation as the Secretary may reasonably
p.000885: require. Such application shall include a plan for the rigorous evaluation of activities funded under the grant or
p.000885: cooperative agreement, including a process and outcome evaluation.
p.000885: (h) DISTRIBUTION OF AWARDS.—In awarding grants and cooper- ative agreements under subsection (a), the Secretary
p.000885: shall ensure that such awards are distributed among the geographical regions of the United States and between
p.000885: urban and rural settings.
p.000885: (i) EVALUATION.—A public organization, private nonprofit orga- nization, political subdivision, consortium of
p.000885: political subdivisions, consortium of States, or Federally recognized Indian tribe or tribal organization receiving a
p.000885: grant or cooperative agreement under sub- section (a) shall prepare and submit to the Secretary at the end of the
p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
p.000885:
p.000885:
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p.000885: January 30, 2020
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p.000893: information as the Secretary may require. Such application shall include a plan for the rigorous
p.000893: evaluation of activities funded with an award under such subsection, including a process and outcomes
p.000893: evalua- tion.
p.000893: (h) EVALUATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
p.000893: (i) AUTHORIZATION OF APPROPRIATION.—There is authorized to be appropriated to carry out this subsection
p.000893: $40,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 through 2003.
p.000893: SEC. 520J. ø290bb–41¿ MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.000893: (a) IN GENERAL.—The Secretary shall award grants in accord- ance with the provisions of this section.
p.000893: (b) MENTAL HEALTH AWARENESS TRAINING GRANTS.—
p.000893: (1) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian tribes,
p.000893: tribal or- ganizations, and nonprofit private entities to train teachers and other relevant school personnel
p.000893: to recognize symptoms of childhood and adolescent mental disorders, to refer family members to the
p.000893: appropriate mental health services if nec- essary, to train emergency services personnel veterans, law en-
p.000893: forcement, and other categories of individuals, as determined by the Secretary, to identify and appropriately
p.000893: respond to per- sons with a mental illness, and to provide education to such
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: PUBLIC HEALTH SERVICE ACT
p.000895: Sec. 520K
p.000895:
p.000895: teachers and personnel regarding resources that are available in the community for individuals with a mental
p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
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p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
p.000899: (D) patient and family satisfaction with program par- ticipation; and
p.000899: (2) provide appropriate information, training, and technical assistance to grant recipients under this section
p.000899: to help such
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000899:
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p.000899: recipients to establish, maintain, or expand their assertive community treatment programs.
p.000899: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.000899: (1) IN GENERAL.—To carry out this section, there is author- ized to be appropriated $5,000,000 for the period of fiscal
p.000899: years 2018 through 2022.
p.000899: (2) USE OF CERTAIN FUNDS.—Of the funds appropriated to carry out this section in any fiscal year, not
p.000899: more than 5 per- cent shall be available to the Assistant Secretary for carrying out subsection (d).
...

p.000903: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless—
p.000903: (1) as part of the application required in section 529, the State involved submits to the Secretary a
p.000903: description of the in- tended use for the fiscal year of the amounts for which the State is applying
p.000903: pursuant to such section;
p.000903: (2) such description identifies the geographic areas within the State in which the greatest numbers of
p.000903: homeless individ- uals with a need for mental health, substance use disorder, and housing services are
p.000903: located;
p.000903: (3) such description provides information relating to the programs and activities to be supported and services
p.000903: to be pro- vided, including information relating to coordinating such pro- grams and activities with any similar
p.000903: programs and activities of public and private entities; and
p.000903: (4) the State agrees that such description will be revised throughout the year as may be necessary to reflect
p.000903: substantial changes in the programs and activities assisted by the State pursuant to section 522.
p.000903: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 521 unless the
p.000903: State involved agrees that, in developing and carrying out the description required in subsection (a), the State
p.000903: will provide public notice with respect to the description (including any revisions) and such
p.000903: opportunities as may be necessary to provide interested persons, such as family members, consumers, and
p.000903: mental health, substance use disorder, and housing agencies, an opportunity to present comments and rec-
p.000903: ommendations with respect to the description.
p.000903: (c) RELATIONSHIP TO STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLAN.—
p.000903: (1) IN GENERAL.—The Secretary may not make payments under section 521 unless the services to be provided
p.000903: pursuant to the description required in subsection (a) are consistent with the State comprehensive mental health
p.000903: services plan required in subpart 2 of part B of title XIX.
p.000903: (2) SPECIAL RULE.—The Secretary may not make payments under section 521 unless the services to be provided
p.000903: pursuant to the description required in subsection (a) have been consid- ered in the preparation of, have been included
p.000903: in, and are con-
p.000903: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000905: 905
p.000905: PUBLIC HEALTH SERVICE ACT
p.000905: Sec. 531
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p.000919: the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid
p.000919: abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established
p.000919: under paragraph (2).
p.000919: (5) PRIORITY CONSIDERATIONS.—In awarding grants under this section, the Secretary shall, as appropriate,
p.000919: give priority to a State that—
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000919:
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p.000919:
p.000921: 921
p.000921: PUBLIC HEALTH SERVICE ACT
p.000921: Sec. 548
p.000921:
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p.000921: January 30, 2020
p.000921: (A)(i) provides civil liability protection for first re- sponders, health professionals, and family members
p.000921: who have received appropriate training in administering a drug or device approved or cleared under the Federal
p.000921: Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (ii) submits to the Secretary a certification by the at- torney general of the State that the attorney general
p.000921: has—
p.000921: (I) reviewed any applicable civil liability protec- tion law to determine the applicability of the law with
p.000921: respect to first responders, health care professionals, family members, and other individuals who—
p.000921: (aa) have received appropriate training in ad- ministering a drug or device approved or cleared under the
p.000921: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (bb) may administer a drug or device ap- proved or cleared under the Federal Food, Drug, and
p.000921: Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (II) concluded that the law described in subclause
p.000921: (I) provides adequate civil liability protection applica- ble to such persons;
p.000921: (B) has a process for enrollment in services and bene- fits necessary by criminal justice agencies to initiate
p.000921: or continue treatment in the community, under which an in- dividual who is incarcerated may, while
p.000921: incarcerated, en- roll in services and benefits that are necessary for the indi- vidual to continue treatment upon
p.000921: release from incarcer- ation;
p.000921: (C) ensures the capability of data sharing with other States, where applicable, such as by making data
p.000921: available to a prescription monitoring hub;
...

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p.000927: January 30, 2020
p.000927:
p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
...

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p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: January 30, 2020
p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
p.000931: provider involved to each child provided access to the system; and
p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
p.000931: (2) SPECIFICATION OF NON-MENTAL HEALTH SERVICES.—The providers referred to in paragraph (1) are providers of
p.000931: medical services other than mental health services, providers of edu- cational services, providers of
...

p.000931: memorandum of understanding regard- ing facilitation of—
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: 933
p.000933: PUBLIC HEALTH SERVICE ACT
p.000933: Sec. 562
p.000933:
p.000933: (A) services available pursuant to title XIX of the So- cial Security Act, including services regarding
p.000933: early peri- odic screening, diagnosis, and treatment;
p.000933: (B) services available under parts B and C of the Indi- viduals with Disabilities Education Act; and
p.000933: (C) services available under other appropriate pro- grams, as identified by the Secretary.
p.000933: (e) GENERAL PROVISIONS REGARDING SERVICES OF SYSTEM.—
p.000933: (1) CASE MANAGEMENT SERVICES.—A funding agreement for a grant under section 561(a) is that a system of care
p.000933: under subsection (a) will provide for the case management of each child provided access to the system in
p.000933: order to ensure that—
p.000933: (A) the services provided through the system to the child are coordinated and that the need of each such child
p.000933: for the services is periodically reassessed;
p.000933: (B) information is provided to the family of the child on the extent of progress being made toward the
p.000933: objectives established for the child under the plan of services imple- mented for the child pursuant to
p.000933: section 563; and
p.000933: (C) the system provides assistance with respect to—
p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
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p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: the non-Federal contributions made with respect to the grant, will not be ex- pended—
p.000933: (1) to purchase or improve real property (including the construction or renovation of facilities);
p.000933: (2) to provide for room and board in residential programs serving 10 or fewer children;
p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
p.000933: (b) MULTIDISCIPLINARY TEAM.—A funding agreement for a grant under section 561(a) is that the plan
p.000933: required in subsection
p.000933: (a) will be developed, and reviewed and as appropriate revised not less than once each year, by a
p.000933: multidisciplinary team of appro- priately qualified individuals who provide services through the sys- tem,
p.000933: including as appropriate mental health services, other health
p.000933:
p.000933: January 30, 2020 As Amended Through P.L. 116-94,
p.000933: Enacted December 20, 2019
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p.000935: 935
p.000935: PUBLIC HEALTH SERVICE ACT
p.000935: Sec. 564
p.000935:
p.000935: services, educational services, social services, and vocational coun- seling and rehabilitation; 16
p.000935: (c) COORDINATION WITH SERVICES UNDER INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—A funding agreement
p.000935: for a grant under section 561(a) is that, with respect to a plan under sub- section (a) for a child,
p.000935: the multidisciplinary team required in sub- section (b) will—
...

p.000935: (4) such other services as may be appropriate in providing for the comprehensive needs with respect to mental
p.000935: health of children with a serious emotional disturbance.
p.000935: (b) COMPREHENSIVE PLAN.—The Secretary may make a grant under section 561(a) only if, with respect to the
p.000935: jurisdiction of the public entity involved, the entity has submitted to the Secretary, and has had approved
p.000935: by the Secretary, a plan for the development of a jurisdiction-wide system of care for community-based services
p.000935: for children with a serious emotional disturbance that specifies the progress the public entity has made in developing
p.000935: the jurisdiction- wide system, the extent of cooperation across agencies serving chil- dren in the establishment of the
p.000935: system, the Federal and non-Fed- eral resources currently committed to the establishment of the sys- tem, and the
p.000935: current gaps in community services and the manner in which the grant under section 561(a) will be
p.000935: expended to ad- dress such gaps and establish local systems of care.
p.000935: (c) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—A fund- ing agreement for a grant under section 561(a) is
p.000935: that, if a charge is imposed for the provision of services under the grant, such charge—
p.000935: (1) will be made according to a schedule of charges that is made available to the public;
p.000935: (2) will be adjusted to reflect the income of the family of the child involved; and
p.000935: (3) will not be imposed on any child whose family has in- come and resources of equal to or less than 100
p.000935: percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised
p.000935: by the Secretary in ac- cordance with section 673(2) of the Omnibus Budget Reconcili- ation Act of 1981.
p.000935: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A funding agreement for a grant under
p.000935: section 561(a) is that the grant, and the non-Federal contributions made with re- spect to the grant,
p.000935: will not be expended to make payment for any item or service to the extent that payment has been
p.000935: made, or can reasonably be expected to be made, with respect to such item or service—
p.000935: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000935: health benefits program; or
p.000935: (2) by an entity that provides health services on a prepaid basis.
p.000935: (e) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 561(a) is
p.000935: that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
p.000935: grant by the public entity involved.
p.000935: (f) REPORTS TO SECRETARY.—A funding agreement for a grant under section 561(a) is that the public entity
p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
...

p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
p.000937:
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
p.000937:
p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
p.000937: first appro- priated under subsection (c), and annually thereafter, submit to the Congress a report
p.000937: summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year and making such
p.000937: recommendations for administrative and legisla- tive initiatives with respect to this section as the Secretary de-
p.000937: termines to be appropriate.
p.000937: (d) DEFINITIONS.—For purposes of this part:
p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
p.000937: or adop- tive, as the case may be) and any foster parents of the child.
p.000937: (3) The term ‘‘funding agreement’’, with respect to a grant under section 561(a) to a public entity, means that
p.000937: the Sec- retary may make such a grant only if the public entity makes the agreement involved.
p.000937: (4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any child who has a
p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
...

p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000949:
p.000949:
p.000949:
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
...

p.000979: the payment of the costs of insurance premiums, or other default by the borrower, as may be authorized by
p.000979: regulations of the Sec- retary in effect at the time the loan is made;
p.000979: (C) provides that periodic installments of principal and interest need not be paid, but interest shall accrue, during
p.000979: any period (i) during which the borrower is pursuing a full-time course of study at an eligible institution
p.000979: (or at an institution defined by section 102(a) of the Higher Edu- cation Act of 1965); (ii) not in
p.000979: excess of four years during which the borrower is a participant in an accredited in- ternship or
p.000979: residency program (including any period in such a program described in subclause (I) or subclause (II) of
p.000979: subparagraph (B)(i)); (iii) not in excess of three years, during which the borrower is a member of the
p.000979: Armed Forces of the United States; (iv) not in excess of three years during which the borrower is in
p.000979: service as a volun- teer under the Peace Corps Act; (v) not in excess of three years during which the
p.000979: borrower is a member of the Na- tional Health Service Corps; (vi) not in excess of three years during
p.000979: which the borrower is in service as a full-time volunteer under title I of the Domestic Volunteer Service Act
p.000979: of 1973; (vii) not in excess of 3 years, for a borrower who has completed an accredited internship or
p.000979: residency training program in osteopathic general practice, family medicine, general internal medicine,
p.000979: preventive medicine, or general pediatrics and who is practicing primary care;
p.000979: (viii) not in excess of 1 year, for borrowers who are grad- uates of schools of chiropractic; (ix) any
p.000979: period not in ex- cess of two years which is described in subparagraph (B)(ii); (x) not in
p.000979: excess of three years, during which the borrower is providing health care services to Indians
p.000979: through an Indian health program (as defined in section
p.000979: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000979:
p.000979:
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p.000979:
p.000981: 981
p.000981: PUBLIC HEALTH SERVICE ACT
p.000981: Sec. 705
p.000981:
p.000981: 108(a)(2)(A) of the Indian Health Care Improvement Act (25 U.S.C. 1616a(a)(2)(A)) 1; and (xi) in addition to all
p.000981: other deferments for which the borrower is eligible under clauses
p.000981: (i) through (x), any period during which the borrower is a member of the Armed Forces on active duty during
p.000981: the Persian Gulf conflict, and any period described in clauses
p.000981: (i) through (xi) shall not be included in determining the 25-year period described in subparagraph (B);
p.000981: (D) provides for interest on the unpaid principal bal- ance of the loan at a yearly rate, not exceeding the
p.000981: applica- ble maximum rate prescribed and defined by the Secretary (within the limits set forth in subsection (b)) on a
...

p.000999: the day on which such installment or evidence was due, or to make the amount of the charge payable to the school not
p.000999: later than the due date of the next installment after receipt by the borrower of notice of the assessment of
p.000999: the charge.
p.000999: (j) AUTHORITY OF SCHOOLS REGARDING RATE OF PAYMENT.—A school may provide, in accordance with regulations
p.000999: of the Sec- retary, that during the repayment period of a loan from a loan fund established pursuant to an agreement
p.000999: under this subpart payments of principal and interest by the borrower with respect to all the outstanding
p.000999: loans made to him from loan funds so established shall be at a rate equal to not less than $40 per month.
p.000999: (k) AUTHORITY REGARDING REPAYMENTS BY SECRETARY.—Upon application by a person who received, and is under
p.000999: an obligation to repay, any loan made to such person as a health professions stu- dent to enable him to study
p.000999: medicine, osteopathy, dentistry, veteri- nary medicine, optometry, pharmacy, or podiatry, the Secretary may
p.000999: undertake to repay (without liability to the applicant) all or any part of such loan, and any interest
p.000999: or portion thereof out- standing thereon, upon his determination, pursuant to regulations establishing
p.000999: criteria therefor, that the applicant—
p.000999: (1) failed to complete such studies leading to his first pro- fessional degree;
p.000999: (2) is in exceptionally needy circumstances;
p.000999: (3) is from a low-income or disadvantaged family as those terms may be defined by such regulations; and
p.000999: (4) has not resumed, or cannot reasonably be expected to resume, the study of medicine, osteopathy,
p.000999: dentistry, veteri- nary medicine, optometry, pharmacy, or podiatric medicine, within two years following the
p.000999: date upon which he terminated such studies.
p.000999: (l) COLLECTION EFFORTS BY SECRETARY.—The Secretary is au- thorized to attempt to collect any loan which was made
p.000999: under this subpart, which is in default, and which was referred to the Sec- retary by a school with
p.000999: which the Secretary has an agreement under this subpart, on behalf of that school under such terms and conditions
p.000999: as the Secretary may prescribe (including reimburse- ment from the school’s student loan fund for
p.000999: expenses the Sec- retary may reasonably incur in attempting collection), but only if the school has
p.000999: complied with such requirements as the Secretary may specify by regulation with respect to the collection
p.000999: of loans under this subpart. A loan so referred shall be treated as a debt subject to section 5514 of
p.000999: title 5, United States Code. Amounts col- lected shall be deposited in the school’s student loan fund. When-
p.000999: ever the Secretary desires the institution of a civil action regarding any such loan, the Secretary shall refer the
p.000999: matter to the Attorney General for appropriate action.
p.000999: (m) ELIMINATION OF STATUTE OF LIMITATION FOR LOAN COL-
p.000999: LECTIONS.—
p.000999: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000999:
p.000999:
p.000999:
p.000999:
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p.001003: capital contribution if the contribution is made from payments under subparagraph (A). A school contribution
p.001003: under such section may not be construed as being an exempt school contribution if the contribution is made
p.001003: pursuant to a Fed- eral capital contribution from such payments.
p.001003: (6) REPORTS BY SCHOOLS.—Each agreement under section 721 with a school of medicine or osteopathic
p.001003: medicine shall provide that the school will submit to the Secretary a report for each 1-year period
p.001003: under paragraph (1) that provides such information as the Secretary determines to be necessary for
p.001003: carrying out this subsection. Each such report shall include statistics concerning the current training or
p.001003: practice status of all graduates of such school whose date of graduation from the school occurred approximately 4
p.001003: years before the end of the 1- year period involved.
p.001003: (c) DEFINITIONS.—For purposes of this section:
p.001003: (1) The term ‘‘exempt contributions’’ means exempt Fed- eral capital contributions and exempt school
p.001003: contributions.
p.001003: (2) The term ‘‘exempt Federal capital contribution’’ means a Federal capital contribution described in subclause
p.001003: (I) of sub- section (a)(2)(A)(ii).
p.001003: (3) The term ‘‘exempt school contribution’’ means a school contribution described in subclause (II)
p.001003: of subsection (a)(2)(A)(ii).
p.001003: (4) The term ‘‘income’’, with respect to a student fund under section 721, means payments of principal
p.001003: and interest on any loan made from the fund, and any other earnings of the fund.
p.001003: (5) The term ‘‘primary health care’’ means family medicine, general internal medicine, general pediatrics, preventive
p.001003: medi- cine, or osteopathic general practice.
p.001003: (d) SENSE OF CONGRESS.—It is the sense of Congress that funds repaid under the loan program under this section
p.001003: should not be transferred to the Treasury of the United States or otherwise used for any other purpose other
p.001003: than to carry out this section.
p.001003: SEC. 724. ø292t¿ INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.
p.001003: (a) FUND AGREEMENTS REGARDING CERTAIN AMOUNTS.—With respect to amounts appropriated under subsection (f),
p.001003: each agree- ment entered into under section 721 with a school shall provide (in addition to the provisions required in
p.001003: subsection (b) of such section) that—
p.001003: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001003:
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p.001005: 1005
p.001005: PUBLIC HEALTH SERVICE ACT
p.001005: Sec. 724
p.001005:
p.001005: (1) any Federal capital contribution made to the student loan fund of the school from such amounts,
p.001005: together with the school contribution appropriate under subsection (b)(2)(B) of such section to the amount of
p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
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p.001021:
p.001021: for-profit private entities as determined appropriate by the Secretary.
p.001021: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with health professional
p.001021: societies, licensing and accreditation entities, health professions schools, and experts in minority health and
p.001021: cultural competency, prevention, and public health and disability groups, community-based organizations, and
p.001021: other organizations as determined appropriate by the Secretary. The Secretary shall coordinate with
p.001021: curricula and research and demonstration projects developed under section 807.
p.001021: (c) DISSEMINATION.—
p.001021: (1) IN GENERAL.—Model curricula developed under this section shall be disseminated through the Internet
p.001021: Clearing- house under section 270 and such other means as determined appropriate by the Secretary.
p.001021: (2) EVALUATION.—The Secretary shall evaluate the adop- tion and the implementation of cultural competency,
p.001021: preven- tion, and public health, and working with individuals with a disability training curricula, and
p.001021: the facilitate inclusion of these competency measures in quality measurement systems as appropriate.
p.001021: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.001021: such sums as may be necessary for each of fiscal years 2010 through 2015.
p.001021:
p.001021: PART C—TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL PEDIATRICS, PHYSICIAN
p.001021: ASSISTANTS, GEN- ERAL DENTISTRY, AND PEDIATRIC DEN- TISTRY
p.001021: Subpart I—Medical Training Generally
p.001021:
p.001021:
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p.001021: January 30, 2020
p.001021: SEC. 747. ø293k¿ PRIMARY CARE TRAINING AND ENHANCEMENT.
p.001021: (a) SUPPORT AND DEVELOPMENT OF PRIMARY CARE TRAINING PROGRAMS.—
p.001021: (1) IN GENERAL.—The Secretary may make grants to, or enter into contracts with, an accredited public or
p.001021: nonprofit pri- vate hospital, school of medicine or osteopathic medicine, aca- demically affiliated physician
p.001021: assistant training program, or a public or private nonprofit entity which the Secretary has de- termined
p.001021: is capable of carrying out such grant or contract—
p.001021: (A) to plan, develop, operate, or participate in an ac- credited professional training program, including
p.001021: an ac- credited residency or internship program in the field of family medicine, general internal
p.001021: medicine, or general pe- diatrics for medical students, interns, residents, or prac- ticing physicians as
p.001021: defined by the Secretary;
p.001021: (B) to provide need-based financial assistance in the form of traineeships and fellowships to medical
p.001021: students, interns, residents, practicing physicians, or other medical personnel, who are participants in any such
p.001021: program, and
p.001021: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001021:
p.001021:
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p.001021:
p.001023: 1023
p.001023: PUBLIC HEALTH SERVICE ACT
p.001023: Sec. 747
p.001023:
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p.001023: January 30, 2020
p.001023: who plan to specialize or work in the practice of the fields defined in subparagraph (A);
p.001023: (C) to plan, develop, and operate a program for the training of physicians who plan to teach in family
p.001023: medi- cine, general internal medicine, or general pediatrics train- ing programs;
p.001023: (D) to plan, develop, and operate a program for the training of physicians teaching in community-based
p.001023: set- tings;
p.001023: (E) to provide financial assistance in the form of traineeships and fellowships to physicians who are
p.001023: partici- pants in any such programs and who plan to teach or con- duct research in a family medicine, general internal
p.001023: medi- cine, or general pediatrics training program;
p.001023: (F) to plan, develop, and operate a physician assistant education program, and for the training of individuals who will
p.001023: teach in programs to provide such training;
p.001023: (G) to plan, develop, and operate a demonstration pro- gram that provides training in new competencies, as rec-
p.001023: ommended by the Advisory Committee on Training in Pri- mary Care Medicine and Dentistry and the National
p.001023: Health Care Workforce Commission established in section 5101 of the Patient Protection and Affordable Care
p.001023: Act, which may include—
p.001023: (i) providing training to primary care physicians relevant to providing care through patient-centered
p.001023: medical homes (as defined by the Secretary for pur- poses of this section);
p.001023: (ii) developing tools and curricula relevant to pa- tient-centered medical homes; and
p.001023: (iii) providing continuing education to primary care physicians relevant to patient-centered medical
p.001023: homes; and
p.001023: (H) to plan, develop, and operate joint degree pro- grams to provide interdisciplinary and
p.001023: interprofessional graduate training in public health and other health profes- sions to provide training in
p.001023: environmental health, infec- tious disease control, disease prevention and health pro- motion, epidemiological
p.001023: studies and injury control.
p.001023: (2) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
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p.001029: (D) faculty salaries during the development phase; and
p.001029: (2) technical assistance provided by an eligible entity.
p.001029: (d) APPLICATION.—A teaching health center seeking a grant under this section shall submit an application
p.001029: to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
p.001029: (e) PREFERENCE FOR CERTAIN APPLICATIONS.—In selecting re- cipients for grants under this section, the Secretary
p.001029: shall give pref- erence to any such application that documents an existing affili- ation agreement with an
p.001029: area health education center program as defined in sections 751 and 799B.
p.001029: (f) DEFINITIONS.—In this section:
p.001029: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001031: 1031
p.001031: PUBLIC HEALTH SERVICE ACT
p.001031: Sec. 749B
p.001031:
p.001031: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an organization capable of providing technical assistance
p.001031: includ- ing an area health education center program as defined in sec- tions 751 and 799B.
p.001031: (2) PRIMARY CARE RESIDENCY PROGRAM.—The term ‘‘pri- mary care residency program’’ means an approved
p.001031: graduate medical residency training program (as defined in section 340H) in family medicine, internal
p.001031: medicine, pediatrics, inter- nal medicine-pediatrics, obstetrics and gynecology, psychiatry, general dentistry,
p.001031: pediatric dentistry, and geriatrics.
p.001031: (3) TEACHING HEALTH CENTER.—
p.001031: (A) IN GENERAL.—The term ‘‘teaching health center’’ means an entity that—
p.001031: (i) is a community based, ambulatory patient care center; and
p.001031: (ii) operates a primary care residency program.
p.001031: (B) INCLUSION OF CERTAIN ENTITIES.—Such term in- cludes the following:
p.001031: (i) A Federally qualified health center (as defined in section 1905(l)(2)(B), of the Social Security Act).
p.001031: (ii) A community mental health center (as defined in section 1861(ff)(3)(B) of the Social Security Act).
p.001031: (iii) A rural health clinic, as defined in section 1861(aa) of the Social Security Act.
p.001031: (iv) A health center operated by the Indian Health Service, an Indian tribe or tribal organization, or an urban
p.001031: Indian organization (as defined in section 4 of the Indian Health Care Improvement Act).
p.001031: (v) An entity receiving funds under title X of the Public Health Service Act.
p.001031: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated, $25,000,000 for fiscal year
p.001031: 2010, $50,000,000 for fiscal year 2011, $50,000,000 for fiscal year 2012, and such sums as may be
p.001031: necessary for each fiscal year thereafter to carry out this section. Not to exceed $5,000,000 annually may be
p.001031: used for technical assistance program grants.
p.001031:
p.001031: Subpart II—Training in Underserved Communities
p.001031:
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p.001031: January 30, 2020
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p.001039: (1) IN GENERAL.—The Secretary may make grants to, and enter into contracts with, schools of medicine, schools
p.001039: of osteo- pathic medicine, teaching hospitals, and graduate medical edu- cation programs, for the purpose of
p.001039: providing support (includ- ing residencies, traineeships, and fellowships) for geriatric training
p.001039: projects to train physicians, dentists and behavioral and mental health professionals who plan to teach
p.001039: geriatric medicine, geriatric behavioral or mental health, or geriatric dentistry.
p.001039: (2) REQUIREMENTS.—Each project for which a grant or con- tract is made under this subsection shall—
p.001039: (A) be staffed by full-time teaching physicians who have experience or training in geriatric medicine or
p.001039: geri- atric behavioral or mental health;
p.001039: (B) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching dentists
p.001039: who have experience or training in geriatric dentistry;
p.001039: (C) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching
p.001039: behav- ioral mental health professionals who have experience or training in geriatric behavioral or mental
p.001039: health;
p.001039: (D) be based in a graduate medical education program in internal medicine or family medicine or in a department of
p.001039: geriatrics or behavioral or mental health;
p.001039: (E) provide training in geriatrics and exposure to the physical and mental disabilities of elderly
p.001039: individuals through a variety of service rotations, such as geriatric consultation services, acute care
p.001039: services, dental services, geriatric behavioral or mental health units, day and home care programs, rehabilitation
p.001039: services, extended care facili- ties, geriatric ambulatory care and comprehensive evalua- tion units, and
p.001039: community care programs for elderly indi- viduals with intellectual disabilities; and
p.001039: (F) provide training in geriatrics through one or both of the training options described in subparagraphs (A)
p.001039: and
p.001039: (B) of paragraph (3).
p.001039: (3) TRAINING OPTIONS.—The training options referred to in subparagraph (F) of paragraph (2) shall be as follows:
p.001039: (A) A 1-year retraining program in geriatrics for—
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001039: Sec. 753 PUBLIC HEALTH SERVICE ACT 1040
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p.001039: January 30, 2020
p.001039:
p.001039: (i) physicians who are faculty members in depart- ments of internal medicine, family medicine, gyne- cology,
p.001039: geriatrics, and behavioral or mental health at schools of medicine and osteopathic medicine;
p.001039: (ii) dentists who are faculty members at schools of dentistry or at hospital departments of dentistry; and
p.001039: (iii) behavioral or mental health professionals who are faculty members in departments of behavioral or mental
p.001039: health; and
p.001039: (B) A 2-year internal medicine or family medicine fel- lowship program providing emphasis in geriatrics,
p.001039: which shall be designed to provide training in clinical geriatrics and geriatrics research for—
p.001039: (i) physicians who have completed graduate med- ical education programs in internal medicine, family
p.001039: medicine, behavioral or mental health, neurology, gyn- ecology, or rehabilitation medicine;
p.001039: (ii) dentists who have demonstrated a commit- ment to an academic career and who have completed
p.001039: postdoctoral dental training, including postdoctoral dental education programs or who have relevant ad-
p.001039: vanced training or experience; and
p.001039: (iii) behavioral or mental health professionals who have completed graduate medical education programs in
p.001039: behavioral or mental health.
p.001039: (4) DEFINITIONS.—For purposes of this subsection:
p.001039: (A) The term ‘‘graduate medical education program’’ means a program sponsored by a school of medicine, a
p.001039: school of osteopathic medicine, a hospital, or a public or private institution that—
p.001039: (i) offers postgraduate medical training in the spe- cialties and subspecialties of medicine; and
p.001039: (ii) has been accredited by the Accreditation Coun- cil for Graduate Medical Education or the American
p.001039: Osteopathic Association through its Committee on Postdoctoral Training.
p.001039: (B) The term ‘‘post-doctoral dental education program’’ means a program sponsored by a school of dentistry, a hos-
p.001039: pital, or a public or private institution that—
p.001039: (i) offers post-doctoral training in the specialties of dentistry, advanced education in general dentistry, or a
p.001039: dental general practice residency; and
p.001039: (ii) has been accredited by the Commission on Dental Accreditation.
p.001039: (c) GERIATRIC FACULTY FELLOWSHIPS.—
p.001039: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program to provide Geriatric Academic
p.001039: Career Awards to eligible individuals to promote the career develop- ment of such individuals as academic
p.001039: geriatricians.
p.001039: (2) ELIGIBLE INDIVIDUALS.—To be eligible to receive an Award under paragraph (1), an individual shall—
p.001039: (A) be board certified or board eligible in internal med- icine, family practice, psychiatry, or licensed
p.001039: dentistry, or have completed any required training in a discipline and
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001041: 1041
p.001041: PUBLIC HEALTH SERVICE ACT
p.001041: Sec. 753
p.001041:
p.001041: employed in an accredited health professions school that is approved by the Secretary;
p.001041: (B) have completed an approved fellowship program in geriatrics or have completed specialty training in geriatrics as
p.001041: required by the discipline and any addition geriatrics training as required by the Secretary; and
p.001041: (C) have a junior (non-tenured) faculty appointment at an accredited (as determined by the Secretary) school of
p.001041: medicine, osteopathic medicine, nursing, social work, psy- chology, dentistry, pharmacy, or other allied
p.001041: health dis- ciplines in an accredited health professions school that is approved by the Secretary.
p.001041: (3) LIMITATIONS.—No Award under paragraph (1) may be made to an eligible individual unless the individual—
p.001041: (A) has submitted to the Secretary an application, at such time, in such manner, and containing such
p.001041: informa- tion as the Secretary may require, and the Secretary has approved such application;
p.001041: (B) provides, in such form and manner as the Sec- retary may require, assurances that the individual
p.001041: will meet the service requirement described in paragraph (6); and
p.001041:
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p.001041: education cen- ters, or at medical schools, schools of dentistry, schools of nursing, schools of pharmacy,
p.001041: schools of social work, grad- uate programs in psychology, or allied health and other health professions
p.001041: schools approved by the Secretary with which the geriatric education centers are affiliated.
p.001041: (C) CME CREDIT.—Participation in a fellowship under this paragraph shall be accepted with respect to complying
p.001041: with continuing health profession education requirements. As a condition of such acceptance, the recipient shall agree
p.001041: to subsequently provide a minimum of 18 hours of vol- untary instructional support through a geriatric
p.001041: education center that is providing clinical training to students or trainees in long-term care settings.
p.001041: (5) ADDITIONAL REQUIRED ACTIVITIES DESCRIBED.—Pursu- ant to paragraph (3), a geriatric education center that
p.001041: receives an award under this subsection shall use such funds to carry out 1 of the following 2 activities.
p.001041: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001041:
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p.001043: 1043
p.001043: PUBLIC HEALTH SERVICE ACT
p.001043: Sec. 753
p.001043:
p.001043: (A) FAMILY CAREGIVER AND DIRECT CARE PROVIDER TRAINING.—A geriatric education center that receives an
p.001043: award under this subsection shall offer at least 2 courses each year, at no charge or nominal cost, to
p.001043: family care- givers and direct care providers that are designed to pro- vide practical training for
p.001043: supporting frail elders and indi- viduals with disabilities. The Secretary shall require such Centers to work
p.001043: with appropriate community partners to develop training program content and to publicize the
p.001043: availability of training courses in their service areas. All family caregiver and direct care provider
p.001043: training pro- grams shall include instruction on the management of psy- chological and behavioral aspects of dementia,
p.001043: communica- tion techniques for working with individuals who have de- mentia, and the appropriate, safe, and
p.001043: effective use of medications for older adults.
p.001043: (B) INCORPORATION OF BEST PRACTICES.—A geriatric education center that receives an award under this
p.001043: sub- section shall develop and include material on depression and other mental disorders common among
p.001043: older adults, medication safety issues for older adults, and management of the psychological and behavioral
p.001043: aspects of dementia and communication techniques with individuals who have dementia in all training courses,
p.001043: where appropriate.
p.001043: (6) TARGETS.—A geriatric education center that receives an award under this subsection shall meet targets
p.001043: approved by the Secretary for providing geriatric training to a certain num- ber of faculty or practitioners during
p.001043: the term of the award, as well as other parameters established by the Secretary.
p.001043: (7) AMOUNT OF AWARD.—An award under this subsection shall be in an amount of $150,000. Not more than 24
p.001043: geriatric education centers may receive an award under this subsection.
p.001043: (8) MAINTENANCE OF EFFORT.—A geriatric education center that receives an award under this subsection shall provide
...

p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: 1047
p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: January 30, 2020
p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
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p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001047: Sec. 757 PUBLIC HEALTH SERVICE ACT 1048
p.001047:
p.001047: port submitted to Congress under section 501(m) an assessment on the effectiveness of the grants under this section in—
p.001047: (1) providing graduate students support for experiential training (internship or field placement);
p.001047: (2) recruiting students interested in behavioral health practice;
p.001047: (3) recruiting students in accordance with subsection (b)(1);
p.001047: (4) developing and implementing interprofessional training and integration within primary care;
p.001047: (5) developing and implementing accredited field place- ments and internships; and
p.001047: (6) collecting data on the number of students trained in be- havioral health care and the number of available
p.001047: accredited in- ternships and field placements.
p.001047: (f) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal years 2019 through 2023, there are
p.001047: authorized to be appropriated to carry out this section $50,000,000, to be allocated as follows:
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p.001065: 1065
p.001065: PUBLIC HEALTH SERVICE ACT
p.001065: Sec. 776
p.001065:
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p.001065: January 30, 2020
p.001065: (B) CHILD AND ADOLESCENT MENTAL AND BEHAVIORAL HEALTH.—For purposes of contracts with respect to child and
p.001065: adolescent mental and behavioral health care, the term ‘‘qualified health professional’’ means a health
p.001065: care professional who—
p.001065: (i) has received specialized training or clinical ex- perience in child and adolescent mental health in psy-
p.001065: chiatry, psychology, school psychology, behavioral pe- diatrics, psychiatric nursing, social work, school social
p.001065: work, substance abuse disorder prevention and treat- ment, marriage and family therapy, school counseling, or
p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
p.001065: (1) are or will be working in a school or other pre-kinder- garten, elementary, or secondary education
p.001065: setting;
p.001065: (2) have familiarity with evidence-based methods and cul- tural and linguistic competence health care services;
p.001065: and
p.001065: (3) demonstrate financial need.
p.001065: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $30,000,000 for each of
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p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001071: 1071
p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
p.001071: center-affili- ated treatment program), correctional facility or program, youth detention center or program,
p.001071: inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or
p.001071: other specialty community be- havioral health center, recovery center, school, community- based organization,
p.001071: telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal
p.001071: organization, Federal medical facility, or any other facility as determined appropriate for purposes of this
p.001071: section by the Secretary.
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p.001077: January 30, 2020
p.001077: 23 So in law. Probably should read ‘‘section’’.
p.001077: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001079: 1079
p.001079: PUBLIC HEALTH SERVICE ACT
p.001079: Sec. 799B
p.001079:
p.001079: gree of doctor of medicine, a degree of doctor of dentistry or an equivalent degree, a degree of doctor of osteopathy,
p.001079: a degree of bachelor of science in pharmacy or an equivalent degree or a degree of doctor of pharmacy or an
p.001079: equivalent degree, a degree of doctor of optometry or an equivalent degree, a degree of doc- tor of podiatric
p.001079: medicine or an equivalent degree, a degree of doctor of veterinary medicine or an equivalent degree, a
p.001079: grad- uate degree in public health or an equivalent degree, and a de- gree of doctor of chiropractic or an
p.001079: equivalent degree, and in- cluding advanced training related to such training provided by any such school.
p.001079: (B) The terms ‘‘graduate program in health administra- tion’’ and ‘‘graduate program in clinical
p.001079: psychology’’ mean an accredited graduate program in a public or nonprofit private institution in a State
p.001079: that provides training leading, respec- tively, to a graduate degree in health administration or an
p.001079: equivalent degree and a doctoral degree in clinical psychology or an equivalent degree.
p.001079: (C) The terms ‘‘graduate program in clinical social work’’ and ‘‘graduate program in marriage and family
p.001079: therapy’’ and ‘‘graduate program in professional counseling’’ mean an accred- ited graduate program in a public or
p.001079: nonprofit private institu- tion in a State that provides training, respectively, in a con- centration in
p.001079: health or mental health care leading to a grad- uate degree in social work and a concentration leading
p.001079: to a graduate degree in marriage and family therapy and a con- centration leading to a graduate degree in
p.001079: counseling.
p.001079: (D) 24 The term ‘‘graduate program in behavioral health and mental health practice’’ means a graduate program
p.001079: in clin- ical psychology, clinical social work, professional counseling, or marriage and family therapy.
p.001079: (E) The term ‘‘accredited’’, when applied to a school of medicine, osteopathic medicine, dentistry, veterinary
p.001079: medicine, optometry, podiatry, pharmacy, public health, or chiropractic, or a graduate program in health
p.001079: administration, clinical psy- chology, clinical social work, professional counseling, or mar- riage and
p.001079: family therapy, means a school or program that is accredited by a recognized body or bodies approved
p.001079: for such purpose by the Secretary of Education, except that a new school or program that, by reason of
p.001079: an insufficient period of operation, is not, at the time of application for a grant or con- tract under this title,
p.001079: eligible for accreditation by such a recog- nized body or bodies, shall be deemed accredited for purposes of
p.001079: this title, if the Secretary of Education finds, after consulta- tion with the appropriate accreditation body or
p.001079: bodies, that there is reasonable assurance that the school or program will meet the accreditation
p.001079: standards of such body or bodies prior to the beginning of the academic year following the normal
p.001079: graduation date of the first entering class in such school or program.
p.001079:
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p.001079: January 30, 2020
p.001079: 24 Section 108(a)(2) of Public Law 105–392 (112 Stat. 3560) provides that paragraph (1)(D) is amended by inserting
p.001079: ‘‘behavioral health and mental health practice,’’ before ‘‘clinical’’. The amendment cannot be executed
p.001079: because the amendment does not specify to which instance of the term ‘‘clinical’’ the amendment applies.
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001081:
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p.001081:
p.001083: 1083
p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
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p.001121: January 30, 2020
p.001121:
p.001121: (5) OPERATION.—Operation. In carrying out the duties under paragraph (2), the Task Force is not subject to
p.001121: the provi- sions of Appendix 2 of title 5, United States Code.
p.001121: (6) INDEPENDENCE.—All members of the Task Force con- vened under this subsection, and any recommendations
p.001121: made by such members, shall be independent and, to the extent prac- ticable, not subject to political pressure.
p.001121: (7) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated such sums as may be necessary
p.001121: for each fiscal year to carry out the activities of the Task Force.
p.001121: (b) PRIMARY CARE RESEARCH.—
p.001121: (1) IN GENERAL.—There is established within the Agency a Center for Primary Care Research (referred to in this
p.001121: sub- section as the ‘‘Center’’) that shall serve as the principal source of funding for primary care practice
p.001121: research in the Depart- ment of Health and Human Services. For purposes of this paragraph, primary care
p.001121: research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral
p.001121: to specialty care, preventive care, and the relation- ship between the clinician and the patient in the context
p.001121: of the family and community.
p.001121: (2) RESEARCH.—In carrying out this section, the Center shall conduct and support research concerning—
p.001121: (A) the nature and characteristics of primary care practice;
p.001121: (B) the management of commonly occurring clinical problems;
p.001121: (C) the management of undifferentiated clinical prob- lems; and
p.001121: (D) the continuity and coordination of health services.
p.001121: SEC. 916. ø299b–5¿ HEALTH CARE PRACTICE AND TECHNOLOGY INNO- VATION.
p.001121: (a) IN GENERAL.—The Director shall promote innovation in evi- dence-based health care practices and technologies by—
p.001121: (1) conducting and supporting research on the develop- ment, diffusion, and use of health care technology;
p.001121: (2) developing, evaluating, and disseminating methodolo- gies for assessments of health care practices and
p.001121: technologies;
p.001121: (3) conducting intramural and supporting extramural as- sessments of existing and new health care
p.001121: practices and tech- nologies;
p.001121: (4) promoting education and training and providing tech- nical assistance in the use of health care
p.001121: practice and tech- nology assessment methodologies and results; and
p.001121: (5) working with the National Library of Medicine and the public and private sector to develop an electronic
p.001121: clearinghouse of currently available assessments and those in progress.
p.001121: (b) SPECIFICATION OF PROCESS.—
p.001121: (1) IN GENERAL.—Not later than December 31, 2000, the Director shall develop and publish a description of the
p.001121: methods used by the Agency and its contractors for health care practice and technology assessment.
...

p.001157: title, there shall be made available for such purpose, from the amounts made available pur- suant to
p.001157: section 241 (relating to evaluations), an amount equal to 40 percent of the maximum amount authorized in such
p.001157: section 241 to be made available for a fiscal year.
p.001157: (d) HEALTH DISPARITIES RESEARCH.—For the purpose of car- rying out the activities under section 903,
p.001157: there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for
p.001157: each of the fiscal years 2002 through 2005.
p.001157: (e) PATIENT SAFETY AND QUALITY IMPROVEMENT.—For the pur- pose of carrying out part C, there are authorized to be
p.001157: appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.
p.001157: SEC. 948. ø299c–7¿ DEFINITIONS.
p.001157: In this title:
p.001157: (1) ADVISORY COUNCIL.—The term ‘‘Advisory Council’’ means the National Advisory Council on Healthcare
p.001157: Research and Quality established under section 941.
p.001157: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001157:
p.001157:
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p.001157:
p.001157:
p.001159: 1159
p.001159: PUBLIC HEALTH SERVICE ACT
p.001159: Sec. 1001
p.001159:
p.001159: (2) AGENCY.—The term ‘‘Agency’’ means the Agency for Healthcare Research and Quality.
p.001159: (3) DIRECTOR.—The term ‘‘Director’’ means the Director of the Agency for Healthcare Research and Quality.
p.001159: TITLE X—POPULATION RESEARCH AND VOLUNTARY FAMILY PLANNING PROGRAMS
p.001159: PROJECT GRANTS AND CONTRACTS FOR FAMILY PLANNING SERVICES
p.001159: SEC. 1001. ø300¿ (a) The Secretary is authorized to make grants to and enter into contracts with public
p.001159: or nonprofit private entities to assist in the establishment and operation of voluntary family planning
p.001159: projects which shall offer a broad range of accept- able and effective family planning methods and services (including
p.001159: natural family planning methods, infertility services, and services for adolescents). To the extent
p.001159: practicable, entities which receive grants or contracts under this subsection shall encourage familiy 1
p.001159: participation in projects assisted under this subsection.
p.001159: (b) In making grants and contracts under this section the Sec- retary shall take into account the number of patients to
p.001159: be served, the extent to which family planning services are needed locally, the relative need of the applicant,
p.001159: and its capacity to make rapid and effective use of such assistance. Local and regional entities shall be assured
p.001159: the right to apply for direct grants and contracts under this section, and the Secretary shall by regulation
p.001159: fully provide for and protect such right.
p.001159: (c) The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such
p.001159: grant by the fair market value of any supplies or equipment furnished the grant re- cipient by the Secretary.
p.001159: The amount by which any such grant is so reduced shall be available for payment by the Secretary of
p.001159: the costs incurred in furnishing the supplies or equipment on which the reduction of such grant is based. Such
p.001159: amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
p.001159: (d) For the purpose of making grants and contracts under this section, there are authorized to be appropriated
p.001159: $30,000,000 for the fiscal year ending June 30, 1971; $60,000,000 for the fiscal year ending June 30, 1972;
p.001159: $111,500,000 for the fiscal year ending June 30, 1973; $111,500,000 each for the fiscal years ending June 30,
p.001159: 1974, and June 30, 1975; $115,000,000 for fiscal year 1976;
p.001159: $115,000,000 for the fiscal year ending September 30, 1977;
p.001159: $136,400,000 for the fiscal year ending September 30, 1978;
p.001159: $200,000,000 for the fiscal year ending September 30, 1979;
p.001159: $230,000,000 for the fiscal year ending September 30, 1980;
p.001159: $264,500,000 for the fiscal year ending September 30, 1981;
p.001159: $126,510,000 for the fiscal year ending September 30, 1982;
p.001159: $139,200,000 for the fiscal year ending September 30, 1983;
p.001159: $150,030,000 for the fiscal year ending September 30, 1984; and
p.001159: $158,400,000 for the fiscal year ending September 30, 1985.
p.001159:
p.001159:
p.001159:
p.001159:
p.001159: January 30, 2020
p.001159: 1 So in law. See section 931(b)(1) of Public Law 97–35 (95 Stat. 570). Probably should be ‘‘fam- ily’’.
p.001159: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001159:
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p.001159: Sec. 1002 PUBLIC HEALTH SERVICE ACT 1160
p.001159:
p.001159: FORMULA GRANTS TO STATES FOR FAMILY PLANNING SERVICES
p.001159: SEC. 1002. ø300a¿ (a) The Secretary is authorized to make grants, from allotments made under subsection (b),
p.001159: to State health authorities to assist in planning, establishing, maintaining, coordi- nating, and evaluating family
p.001159: planning services. No grant may be made to a State health authority under this section unless such au- thority has
p.001159: submitted, and had approved by the Secretary, a State plan for a coordinated and comprehensive program of
p.001159: family plan- ning services.
p.001159: (b) The sums appropriated to carry out the provisions of this section shall be allotted to the States by the
p.001159: Secretary on the basis of the population and the financial need of the respective States.
p.001159: (c) For the purposes of this section, the term ‘‘State’’ includes the Commonwealth of Puerto Rico, the
p.001159: Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, the District of Colum- bia, and the Trust
p.001159: Territory of the Pacific Islands.
p.001159: (d) For the purpose of making grants under this section, there are authorized to be appropriated $10,000,000 for
p.001159: the fiscal year ending June 30, 1971; $15,000,000 for the fiscal year ending June 30, 1972; and $20,000,000
p.001159: for the fiscal year ending June 30, 1973.
p.001159: TRAINING GRANTS AND CONTRACTS
p.001159: SEC. 1003. ø300a–1¿ (a) The Secretary is authorized to make grants to public or nonprofit private entities and
p.001159: to enter into con- tracts with public or private entities and individuals to provide the training for personnel to
p.001159: carry out family planning service pro- grams described in section 1001 or 1002.
p.001159: (b) For the purpose of making payments pursuant to grants and contracts under this section, there are
p.001159: authorized to be appro- priated $2,000,000 for the fiscal year ending June 30, 1971;
p.001159: $3,000,000 for the fiscal year ending June 30, 1972; $4,000,000 for the fiscal year ending June 30, 1973; and
p.001159: $3,000,000 each for the fiscal years ending June 30, 1974, and June 30, 1975; $4,000,000 for fiscal year
p.001159: 1976; $5,000,000 for the fiscal year ending Sep- tember 30, 1977; $3,000,000 for the fiscal year ending
p.001159: September 30, 1978; $3,100,000 for the fiscal year ending September 30, 1979;
p.001159: $3,600,000 for the fiscal year ending September 30, 1980;
p.001159: $4,100,000 for the fiscal year ending September 30, 1981;
p.001159: $2,920,000 for the fiscal year ending September 30, 1982;
p.001159: $3,200,000 for the fiscal year ending September 30, 1983;
p.001159: $3,500,000 for the fiscal year ending September 30, 1984; and
p.001159: $3,500,000 for the fiscal year ending September 30, 1985.
p.001159:
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p.001159: January 30, 2020
p.001159:
p.001159: RESEARCH
p.001159: SEC. 1004. ø300a–2¿ The Secretary may—
p.001159: (1) conduct, and
p.001159: (2) make grants to public or nonprofit private entities and enter into contracts with public or private entities and
p.001159: individ- uals for projects for,
p.001159: research in the biomedical, contraceptive development, behavioral, and program implementation fields related to
p.001159: family planning and population.
p.001159: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001159:
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p.001161: 1161
p.001161: PUBLIC HEALTH SERVICE ACT
p.001161: Sec. 1006
p.001161:
p.001161: INFORMATIONAL AND EDUCATIONAL MATERIALS
p.001161: SEC. 1005. ø300a–3¿ (a) The Secretary is authorized to make grants to public or nonprofit private entities and
p.001161: to enter into con- tracts with public or private entities and individuals to assist in de- veloping and making
p.001161: available family planning and population growth information (including educational materials) to all persons
p.001161: desiring such information (or materials).
p.001161: (b) For the purpose of making payments pursuant to grants and contracts under this section, there are
p.001161: authorized to be appro- priated $750,000 for the fiscal year ending June 30, 1971;
p.001161: $1,000,000 for the fiscal year ending June 30, 1972; $1,250,000 for the fiscal year ending June 30, 1973;
p.001161: $909,000 each for the fiscal years ending June 30, 1974, and June 30, 1975; $2,000,000 for fis- cal year 1976;
p.001161: $2,500,000 for the fiscal year ending September 30, 1977; $600,000 for the fiscal year ending September
p.001161: 30, 1978;
p.001161: $700,000 for the fiscal year ending September 30, 1979; $805,000 for the fiscal year ending September 30,
p.001161: 1980; $926,000 for the fis- cal year ending September 30, 1981; $570,000 for the fiscal year ending
p.001161: September 30, 1982; $600,000 for the fiscal year ending September 30, 1983; $670,000 for the fiscal year ending
p.001161: September 30, 1984; and $700,000 for the fiscal year ending September 30, 1985.
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p.001161: January 30, 2020
p.001161:
p.001161: REGULATIONS AND PAYMENTS
p.001161:
p.001161: SEC. 1006. ø300a–4¿ (a) Grants and contracts made under this title shall be made in accordance with such regulations as
p.001161: the Sec- retary may promulgate. The amount of any grant under any sec- tion of this title shall be
p.001161: determined by the Secretary; except that no grant under any such section for any program or project for
p.001161: a fiscal year beginning after June 30, 1975, may be made for less than 90 per centum of its costs
p.001161: (as determined under regulations of the Secretary) unless the grant is to be made for a program or
p.001161: project for which a grant was made (under the same section) for the fiscal year ending June 30, 1975,
p.001161: for less than 90 per centum of its costs (as so determined), in which case a grant under such section
p.001161: for that program or project for a fiscal year beginning after that date may be made for a percentage which
p.001161: shall not be less than the percentage of its costs for which the fiscal year 1975 grant was made.
p.001161: (b) Grants under this title shall be payable in such install- ments and subject to such conditions as
p.001161: the Secretary may deter- mine to be appropriate to assure that such grants will be effectively utilized for the
p.001161: purposes for which made.
p.001161: (c) A grant may be made or contract entered into under section 1001 or 1002 for a family planning service project or
p.001161: program only upon assurances satisfactory to the Secretary that—
p.001161: (1) priority will be given in such project or program to the furnishing of such services to persons from
p.001161: low-income fami- lies; and
p.001161: (2) no charge will be made in such project or program for services provided to any person from a
p.001161: low-income family ex- cept to the extent that payment will be made by a third party
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001161:
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p.001161: Sec. 1007 PUBLIC HEALTH SERVICE ACT 1162
p.001161:
p.001161: (including a government agency) which is authorized or is under legal obligation to pay such charge.
p.001161: For purposes of this subsection, the term ‘‘low-income family’’ shall be defined by the Secretary in accordance with
p.001161: such criteria as he may prescribe so as to insure that economic status shall not be a deterrent to
p.001161: participation in the programs assisted under this title. (d)(1) A grant may be made or a contract entered
p.001161: into under section 1001 or 1005 only upon assurances satisfactory to the Sec- retary that informational or
p.001161: educational materials developed or made available under the grant or contract will be suitable for the purposes of
p.001161: this title and for the population or community to which they are to be made available, taking into account the
p.001161: educational and cultural background of the individuals to whom such materials are addressed and the standards of such
p.001161: population or community
p.001161: with respect to such materials.
p.001161: (2) In the case of any grant or contract under section 1001, such assurances shall provide for the
p.001161: review and approval of the suitability of such materials, prior to their distribution, by an advi- sory committee
p.001161: established by the grantee or contractor in accord- ance with the Secretary’s regulations. Such a
p.001161: committee shall in- clude individuals broadly representative of the population or com- munity to which the
p.001161: materials are to be made available.
p.001161: VOLUNTARY PARTICIPATION
p.001161: SEC. 1007. ø300a–5¿ The acceptance by any individual of fam- ily planning services or family planning or population
p.001161: growth infor- mation (including educational materials) provided through finan- cial assistance under this title
p.001161: (whether by grant or contract) shall be voluntary and shall not be a prerequisite to eligibility for or re- ceipt of
p.001161: any other service or assistance from, or to participation in, any other program of the entity or individual
p.001161: that provided such service or information.
p.001161: PROHIBITION OF ABORTION
p.001161: SEC. 1008. 2 ø300a–6¿ None of the funds appropriated under this title shall be used in programs where abortion
p.001161: is a method of family planning.
p.001161: TITLE XI—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME
p.001161: PART A—GENETIC DISEASES
p.001161: RESEARCH PROJECT GRANTS AND CONTRACTS
p.001161: SEC. 1102. ø300b–1¿ In carrying out section 301, the Secretary, may make grants to public and nonprofit private
p.001161: entities, and may enter into contracts with public and private entities and individ- uals, for projects for
p.001161: (1) basic or applied research leading to the un- derstanding, diagnosis, treatment, and control of genetic
p.001161: diseases,
p.001161: (2) planning, establishing, demonstrating, and developing special programs for the training of genetic
p.001161: counselors, social and behav-
p.001161:
p.001161:
p.001161:
p.001161: January 30, 2020
p.001161: 2 Section 1009 was repealed by section 601(a)(1)(G) of Public Law 105–362 (112 Stat. 3285).
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001161:
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p.001163: 1163
p.001163: PUBLIC HEALTH SERVICE ACT
p.001163: Sec. 1104
p.001163:
p.001163: ioral scientists, and other health professionals, (3) the development of programs to educate practicing
p.001163: physicians, other health profes- sionals and the public regarding the nature of genetic processes, the
p.001163: inheritance patterns of genetic diseases, and the means, meth- ods, and facilities available to diagnose, control,
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p.001173: Government under section 9(a) of such Act.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001173:
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p.001173: Sec. 1112 PUBLIC HEALTH SERVICE ACT 1174
p.001173:
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p.001173: January 30, 2020
p.001173:
p.001173: SEC. 1112. ø300b–11¿ CLEARINGHOUSE OF NEWBORN SCREENING IN- FORMATION.
p.001173: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001173: Administration (re- ferred to in this part as the ‘‘Administrator’’), in consultation with the Director of the Centers
p.001173: for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish and
p.001173: maintain a central clearinghouse of current educational and family support and services information,
p.001173: materials, resources, re- search, and data on newborn screening to—
p.001173: (1) enable parents and family members of newborns, health professionals, industry representatives, and
p.001173: other mem- bers of the public to increase their awareness, knowledge, and understanding of newborn screening;
p.001173: (2) increase awareness, knowledge, and understanding of newborn diseases and screening services for expectant
p.001173: individ- uals and families;
p.001173: (3) maintain current information on quality indicators to measure performance of newborn screening, such as
p.001173: false-posi- tive rates and other quality indicators as determined by the Advisory Committee under section
p.001173: 1111;
p.001173: (4) maintain current information on the number of condi- tions for which screening is conducted in each State;
p.001173: and
p.001173: (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect
p.001173: to condi- tions detected by newborn screening.
p.001173: (b) INTERNET AVAILABILITY.—The Secretary, acting through the Administrator, shall ensure that the clearinghouse
p.001173: described under subsection (a)—
p.001173: (1) is available on the Internet;
p.001173: (2) includes an interactive forum;
p.001173: (3) is updated on a regular basis, but not less than quar- terly; and
p.001173: (4) provides—
p.001173: (A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have
p.001173: dem- onstrated expertise in newborn screening that supply re- search-based information on newborn screening
p.001173: tests cur- rently available throughout the United States;
p.001173: (B) information about newborn conditions and screen- ing services available in each State from
p.001173: laboratories cer- tified under subpart 2 of part F of title III, including infor- mation about supplemental screening
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p.001197: PUBLIC HEALTH SERVICE ACT
p.001197: Sec. 1252
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p.001197: January 30, 2020
p.001197: (A) representatives of—
p.001197: (i) the corresponding State or American Indian consortium agencies involved;
p.001197: (ii) public and nonprofit private health related or- ganizations;
p.001197: (iii) other disability advisory or planning groups within the State or American Indian consortium;
p.001197: (iv) members of an organization or foundation rep- resenting individuals with traumatic brain injury in that
p.001197: State or American Indian consortium; and
p.001197: (v) injury control programs at the State or local level if such programs exist; and
p.001197: (B) a substantial number of individuals with traumatic brain injury, or the family members of such individuals.
p.001197: (c) MATCHING FUNDS.—
p.001197: (1) IN GENERAL.—With respect to the costs to be incurred by a State or American Indian consortium in
p.001197: carrying out the purpose described in subsection (a), the Secretary may make a grant under such subsection only
p.001197: if the State or American In- dian consortium agrees to make available non-Federal con- tributions toward
p.001197: such costs in an amount that is not less than
p.001197: $1 for each $2 of Federal funds provided under the grant.
p.001197: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001197: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001197: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001197: not be included in determining the amount of such contributions.
p.001197: (d) APPLICATION FOR GRANT.—The Secretary may make a grant under subsection (a) only if an application for the
p.001197: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.001197: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
p.001197: out this section.
p.001197: (e) USE OF STATE AND AMERICAN INDIAN CONSORTIUM GRANTS.—
p.001197: (1) COMMUNITY SERVICES AND SUPPORTS.—A State or American Indian consortium shall (directly or
p.001197: through awards of contracts to nonprofit private entities) use amounts received under a grant under this section for
p.001197: the following:
...

p.001197: (ii) shall be designed for children, youth, and adults with traumatic brain injury.
p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: Sec. 1252 PUBLIC HEALTH SERVICE ACT 1198
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p.001197: January 30, 2020
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p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
p.001197: support, peer mentoring, and parent to parent programs.
p.001197: (D) To develop individual and family service coordina- tion or case management systems.
p.001197: (E) To support other needs identified by the advisory board under subsection (b) for the State or
p.001197: American In- dian consortium involved.
p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
p.001197: (D) develop best practices in areas such as family or consumer support, return to work, housing or
p.001197: supportive living personal assistance services, assistive technology and devices, behavioral health
p.001197: services, substance abuse services, and traumatic brain injury treatment and reha- bilitation;
p.001197: (E) tailor existing State or American Indian consor- tium systems to provide accommodations to the needs
p.001197: of individuals with traumatic brain injury (including systems administered by the State or American Indian
p.001197: consortium departments responsible for health, mental health, labor/ employment, education, intellectual
p.001197: disabilities or develop- mental disorders, transportation, and correctional sys- tems);
p.001197: (F) improve data sets coordinated across systems and other needs identified by a State or American
p.001197: Indian con- sortium plan supported by its advisory council; and
p.001197: (G) develop capacity within targeted communities.
p.001197: (f) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.001197: coordinated as appropriate
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
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p.001199: (h) DEFINITIONS.—For purposes of this section:
p.001199: (1) The terms ‘‘American Indian consortium’’ and ‘‘State’’ have the meanings given to those terms in section
p.001199: 1253.
p.001199: (2) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001199: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001199: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001199: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001199: private entities.
p.001199: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001199: to be appropriated
p.001199: $7,321,000 for each of fiscal years 2020 through 2024.
p.001199: SEC. 1253. ø300d–53¿ STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.
p.001199: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001199: Living, shall make grants to protection and advocacy systems for the purpose of ena- bling such systems
p.001199: to provide services to individuals with trau- matic brain injury.
p.001199: (b) SERVICES PROVIDED.—Services provided under this section may include the provision of—
p.001199: (1) information, referrals, and advice;
p.001199: (2) individual and family advocacy;
p.001199: (3) legal representation; and
p.001199: (4) specific assistance in self-advocacy.
p.001199: (c) APPLICATION.—To be eligible to receive a grant under this section, a protection and advocacy system shall
p.001199: submit an applica- tion to the Secretary at such time, in such form and manner, and accompanied by such
p.001199: information and assurances as the Secretary may require.
p.001199: (d) APPROPRIATIONS LESS THAN $2,700,000.—
p.001199: (1) IN GENERAL.—With respect to any fiscal year in which the amount appropriated under subsection (l) to carry
p.001199: out this section is less than $2,700,000, the Secretary shall make grants from such amount to
p.001199: individual protection and advocacy systems within States to enable such systems to plan for, de- velop
p.001199: outreach strategies for, and carry out services authorized under this section for individuals with traumatic brain
p.001199: injury.
p.001199: (2) AMOUNT.—The amount of each grant provided under paragraph (1) shall be determined as set forth in
p.001199: paragraphs
p.001199: (2) and (3) of subsection (e).
p.001199: (e) APPROPRIATIONS OF $2,700,000 OR MORE.—
p.001199: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001199: Sec. 1253 PUBLIC HEALTH SERVICE ACT 1200
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p.001219: connection with a group health plan in the small or large group market (as defined in section 2791(e)), an
p.001219: affiliation period consistent with the provisions of section 2701(g).
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001219: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1220
p.001219:
p.001219: service. Such term includes a health service directly associated with an organ transplant only if such
p.001219: organ transplant was re- quired to be included in basic health services on April 15, 1985. For purposes of this
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p.001221: and professional, technical, and administrative staff.
p.001221: (6) The term ‘‘health systems agency’’ means an entity which is designated in accordance with section 1515 of
p.001221: this Act.
p.001221: (7) The term ‘‘medically underserved population’’ means the population of an urban or rural area
p.001221: designated by the Secretary as an area with a shortage of personal health services or a popu- lation
p.001221: group designated by the Secretary as having a shortage of such services. Such a designation may be made
p.001221: by the Secretary only after consideration of the comments (if any) of (A) each State health planning and development
p.001221: agency which covers (in whole or in part) such urban or rural area or the area in which such popu- lation group
p.001221: resides, and (B) each health systems agency des- ignated for a health service area which covers (in whole or in
p.001221: part) such urban or rural area or the area in which such population group resides.
p.001221: (8)(A) The term ‘‘community rating system’’ means the sys- tems, described in subparagraphs (B) and (C),
p.001221: of fixing rates of payments for health services. A health maintenance organization may fix its rates of
p.001221: payments under the system described in sub- paragraph (B) or (C) or under both such systems, but a
p.001221: health maintenance organization may use only one such system for fixing its rates of payments for any one group.
p.001221: (B) A system of fixing rates of payment for health services may provide that the rates shall be fixed on a
p.001221: per-person or per-family basis and may authorize the rates to vary with the number of per- sons in a family, but,
p.001221: except as authorized in subparagraph (D), such rates must be equivalent for all individuals and for all
p.001221: fami- lies of similar composition.
p.001221: (C) A system of fixing rates of payment for health services may provide that the rates shall be fixed for individuals
p.001221: and families by groups. Except as authorized in subparagraph (D), such rates must be equivalent for all individuals in
p.001221: the same group and for all fami- lies of similar composition in the same group. If a health mainte- nance
p.001221: organization is to fix rates of payment for individuals and families by groups, it shall—
p.001221: (i)(I) classify all of the members of the organization into classes based on factors which the health
p.001221: maintenance organization determines predict the differences in the use of health services by the
p.001221: individuals or families in each
p.001221: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001221:
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p.001221: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1222
p.001221:
p.001221: class and which have not been disapproved by the Sec- retary,
p.001221: (II) determine its revenue requirements for providing services to the members of each class established
p.001221: under subclause (I), and
p.001221: (III) fix the rates of payments for the individuals and families of a group on the basis of a composite of the
p.001221: orga- nization’s revenue requirements determined under sub- clause (II) for providing services to them as
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p.001261: Sec. 1640 PUBLIC HEALTH SERVICE ACT 1262
p.001261:
p.001261: by such person with the Secretary and the Secretary has dismissed such complaint or the Attorney General has not
p.001261: brought a civil ac- tion for compliance with such assurance within six months after the date on which the
p.001261: complaint was filed with the Secretary.
p.001261: PART D—AREA HEALTH SERVICES DEVELOPMENT FUNDS
p.001261: DEVELOPMENT GRANTS FOR AREA HEALTH SERVICES DEVELOPMENT FUNDS
p.001261: SEC. 1640. ø300t¿ (a) The Secretary shall make in each fiscal year a grant to each health systems agency—
p.001261: (1) with which there is in effect a designation agreement under section 1515(c),
p.001261: (2) which has in effect an HSP and AIP reviewed by the Statewide Health Coordinating Council, and
p.001261: (3) which, as determined under the review made under section 1535(c), is organized and operated in the
p.001261: manner pre- scribed by section 1512(b) and is performing its functions under section 1513 in a
p.001261: manner satisfactory to the Secretary,
p.001261: to enable the agency to establish and maintain an Area Health Services Development Fund from which it
p.001261: may make grants and enter into contracts in accordance with section 1513(c)(3).
p.001261: (b)(1) Except as provided in paragraph (2), the amount of any grant under subsection (a) shall be
p.001261: determined by the Secretary after taking into consideration the population of the health service area for which
p.001261: the health systems agency is designated, the aver- age family income of the area, and the supply of health
p.001261: services in the area.
p.001261: (2) The amount of any grant under subsection (a) to a health systems agency for any fiscal year may
p.001261: not exceed the product of
p.001261: $1 and the population of the health service area for which such agency is designated.
p.001261: (c) No grant may be made under subsection (a) unless an appli- cation therefor has been submitted to, and
p.001261: approved by, the Sec- retary. Such an application shall be submitted in such form and manner and contain
p.001261: such information as the Secretary may re- quire.
p.001261: (d) For the purpose of making payments pursuant to grants under subsection (a), there are authorized
p.001261: to be appropriated
p.001261: $25,000,000 for the fiscal year ending June 30, 1975, $75,000,000 for the fiscal year ending June 30, 1976,
p.001261: $120,000,000 each for the fiscal years ending September 30, 1977, and September 30, 1978,
p.001261: $20,000,000 for the fiscal year ending September 30, 1981, and
p.001261: $30,000,000 for the fiscal year ending September 30, 1982.
p.001261: PART E—PROGRAM TO ASSIST AND ENCOURAGE THE VOLUNTARY DISCONTINUANCE OF UNNEEDED HOSPITAL SERVICES
p.001261: AND THE CONVERSION OF UNNEEDED HOSPITAL SERVICES TO OTHER HEALTH SERVICES NEEDED BY THE
p.001261: COMMUNITY
p.001261:
p.001261:
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p.001261: January 30, 2020
p.001261: ESTABLISHMENT OF PROGRAM
p.001261: SEC. 1641. ø300t–11¿ The Secretary shall, by April 1, 1980, es- tablish a program under which—
p.001261: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001261:
p.001261:
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p.001269: appropriate use of health care.
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p.001269: January 30, 2020
p.001269: INFORMATION PROGRAMS
p.001269: SEC. 1704. ø300u–3¿ The Secretary is authorized to conduct and support by grant or contract (and encourage
p.001269: others to support) such activities as may be required to make information respecting health information and
p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001269:
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p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
p.001271: dis- eases; and shall be designed to reach populations of different languages and of different social and
p.001271: economic backgrounds.
p.001271: (2) Securing the cooperation of the communication media, providers of health care, schools, and others in
p.001271: activities de- signed to promote and encourage the use of health maintaining information and behavior.
p.001271: (3) The study of health information and promotion in ad- vertising and the making to concerned Federal
p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others of information for use by the public respecting health in- surance policies and prepaid health plans,
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p.001339: 20. If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued
p.001339: on March 2, 1989, with respect to part 291 of title 21, Code of Federal Regulations (docket numbered
p.001339: 88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and
p.001339: the provisions of para- graph (3) of this subsection are deemed to be incorporated into such rule.
p.001339: (d) DEFINITIONS.—For purposes of this section:
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p.001339: January 30, 2020
p.001339: 20 Enacted July 10, 1992.
p.001339:
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: 1341
p.001341: PUBLIC HEALTH SERVICE ACT
p.001341: Sec. 2001
p.001341:
p.001341: (1) The term ‘‘interim maintenance services’’ means the provision of methadone in a treatment program under the
p.001341: cir- cumstances described in paragraphs (1) and (2) of subsection (a).
p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
p.001341: (3) The term ‘‘treatment program’’ means a public or non- profit private program of treatment for
p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
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p.001341:
p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
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p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001341: January 30, 2020
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p.001341: and are frequently associated with or are a cause of other trou- blesome situations in the family; and
p.001341: (B) such problems are best approached through a variety of integrated and essential services provided to
p.001341: adolescents and their families by other family members, religious and chari- table organizations, voluntary
p.001341: associations, and other groups in the private sector as well as services provided by publicly spon- sored initiatives;
p.001341: (9) a wide array of educational, health, and supportive services are not available to adolescents with such
p.001341: problems or to their families, or when available frequently are fragmented and thus are of limited
p.001341: effectiveness in discouraging adolescent premarital sexual relations and the consequences of such rela- tions;
p.001341: (10)(A) prevention of adolescent sexual activity and adoles- cent pregnancy depends primarily upon developing strong
p.001341: fam- ily values and close family ties, and since the family is the basic social unit in which the
p.001341: values and attitudes of adoles- cents concerning sexuality and pregnancy are formed, pro- grams designed to
p.001341: deal with issues of sexuality and pregnancy will be successful to the extent that such programs encourage and
p.001341: sustain the role of the family in dealing with adolescent sexual activity and adolescent pregnancy;
p.001341: (B) Federal policy therefore should encourage the develop- ment of appropriate health, educational, and social
p.001341: services where such services are now lacking or inadequate, and the better coordination of existing
p.001341: services where they are avail- able; and
p.001341: (C) services encouraged by the Federal Government should promote the involvement of parents with their adolescent chil-
p.001341: dren, and should emphasize the provision of support by other family members, religious and charitable
p.001341: organizations, vol- untary associations, and other groups in the private sector in order to help adolescents
p.001341: and their families deal with complex issues of adolescent premarital sexual relations and the con- sequences of
p.001341: such relations; and
p.001341: (11)(A) there has been limited research concerning the so- cietal causes and consequences of adolescent pregnancy;
p.001341: (B) there is limited knowledge concerning which means of intervention are effective in mediating or
p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
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p.001343: January 30, 2020
p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
p.001343: care services in a single setting or the capability of creating a network through which all care services
p.001343: would be provided; or
p.001343: (B) in the case of an organization which will provide prevention services, the capability of providing
p.001343: such serv- ices;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001343: Sec. 2002 PUBLIC HEALTH SERVICE ACT 1344
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p.001343: January 30, 2020
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p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
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p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
p.001345: prevention services in easily accessible locations. Dem- onstration projects shall, as appropriate,
p.001345: provide, supplement, or improve the quality of such services. Demonstration projects shall use such methods
p.001345: as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of
p.001345: adolescents and to make use of support systems such as other family members, friends, religious and charitable
p.001345: organizations, and voluntary asso- ciations.
p.001345: (b) Grants under this title for demonstration projects may be for the provision of—
p.001345: (1) care services;
p.001345: (2) prevention services; or
p.001345: (3) a combination of care services and prevention services.
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p.001345: USES OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2004. ø300z–3¿ (a) Except as provided in subsection (b), funds provided for demonstration projects
p.001345: for services under this title may be used by grantees only to—
p.001345: (1) provide to eligible persons—
p.001345: (A) care services;
p.001345: (B) prevention services; or
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345: (C) care and prevention services (in the case of a grantee who is providing a combination of care and
p.001345: pre- vention services);
p.001345: (2) coordinate, integrate, and provide linkages among pro- viders of care, prevention, and other services
p.001345: for eligible per- sons in furtherance of the purposes of this title;
p.001345: (3) provide supplemental services where such services are not adequate or not available to eligible persons in
p.001345: the commu- nity and which are essential to the care of pregnant adoles- cents and to the prevention of
p.001345: adolescent premarital sexual re- lations and adolescent pregnancy;
p.001345: (4) plan for the administration and coordination of preg- nancy prevention services and programs of care
p.001345: for pregnant adolescents and adolescent parents which will further the ob- jectives of this title; and
p.001345: (5) fulfill assurances required for grant approval by section 2006.
p.001345: (b)(1) No funds provided for a demonstration project for serv- ices under this title may be used for
p.001345: the provision of family plan- ning services (other than counseling and referral services) to ado- lescents
p.001345: unless appropriate family planning services are not other- wise available in the community.
p.001345: (2) Any grantee who receives funds for a demonstration project for services under this title and who, after determining
p.001345: under para- graph (1) that appropriate family planning services are not other- wise available in the
p.001345: community, provides family planning services (other than counseling and referral services) to adolescents may
p.001345: only use funds provided under this title for such family planning services if all funds received by such
p.001345: grantee from all other sources to support such family planning services are insufficient to support such family
p.001345: planning services.
p.001345: (c) Grantees who receive funds for a demonstration project for services under this title shall charge fees for
p.001345: services pursuant to a fee schedule approved by the Secretary as a part of the applica- tion described
p.001345: in section 2006 which bases fees charged by the grantee on the income of the eligible person or the parents or
p.001345: legal guardians of the eligible person and takes into account the dif- ficulty adolescents face in
p.001345: obtaining resources to pay for services. A grantee who receives funds for a demonstration project for serv- ices
p.001345: under this title may not, in any case, discriminate with regard to the provision of services to any individual
p.001345: because of that indi- vidual’s inability to provide payment for such services, except that in determining the
p.001345: ability of an unemancipated minor to provide payment for services, the income of the family of an unemancipated
p.001345: minor shall be considered in determining the ability of such minor to make such payments unless the parents or
p.001345: guardians of the unemancipated minor refuse to make such payments.
p.001345: PRIORITIES, AMOUNTS, AND DURATION OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2005. ø300z–4¿ (a) In approving applications for grants for demonstration projects for services under
p.001345: this title, the Sec- retary shall give priority to applicants who—
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001349: sons entitled to services under parts B and E of title IV and title XX of the Social Security Act;
p.001349: (16)(A) a description of—
p.001349: (i) the schedule of fees to be used in the provision of services, which shall comply with section
p.001349: 2004(c) and which shall be designed to cover all reasonable direct and indirect costs incurred by the applicant
p.001349: in providing serv- ices; and
p.001349: (ii) a corresponding schedule of discounts to be applied to the payment of such fees, which shall comply with
p.001349: sec- tion 2004(c) and which shall be adjusted on the basis of the ability of the eligible person to pay;
p.001349: (B) assurances that the applicant has made and will con- tinue to make every reasonable effort—
p.001349: (i) to secure from eligible persons payment for services in accordance with such schedules;
p.001349: (ii) to collect reimbursement for health or other serv- ices provided to persons who are entitled to have
p.001349: payment made on their behalf for such services under any Federal or other government program or private
p.001349: insurance pro- gram; and
p.001349: (iii) to seek such reimbursement on the basis of the full amount of fees for services without
p.001349: application of any discount; and
p.001349: (C) assurances that the applicant has submitted or will submit to the Secretary such reports as the Secretary
p.001349: may re- quire to determine compliance with this paragraph;
p.001349: (17) assurances that the applicant will make maximum use of funds available under title X of this Act;
p.001349: (18) assurances that the acceptance by any individual of family planning services or family planning
p.001349: information (in- cluding educational materials) provided through financial as- sistance under this title
p.001349: shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service fur-
p.001349: nished by the applicant;
p.001349: (19) assurances that fees collected by the applicant for services rendered in accordance with this title shall
p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
p.001351: (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents
p.001351: or guardians of any unemancipated minor requesting services from the applicant and, except as provided in
p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001425: should be extended beyond fiscal year 1990 and may include any recommendations of the Secretary for
p.001425: appro- priate administrative and legislative initiatives.
p.001425: SEC. 2413. ø300dd–12¿ DEFINITIONS.
p.001425: For purposes of this part:
p.001425: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such terms in sections
p.001425: 4(b) and 4(c) of the Indian Self-Determination and Education Assistance Act.
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p.001425: (2) The term ‘‘infected with the etiologic agent for acquired immune deficiency syndrome’’ includes any condition
p.001425: arising from infection with such etiologic agent.
p.001425: (3)(A) An individual is considered to have low income if the individual’s income does not exceed 200 percent of
p.001425: the official poverty line.
p.001425: (B) The term ‘‘official poverty line’’ refers, with respect to an individual, to the official poverty
p.001425: line defined by the Office of Management and Budget, and revised annually in accord- ance with section
p.001425: 673(2) of the Omnibus Budget Reconciliation Act of 1981, applicable to a family of the size involved.
p.001425: (4)(A) The term ‘‘State’’ means, except as provided in sub- paragraph (B), each of the several States, the
p.001425: District of Co- lumbia, the Commonwealth of Puerto Rico, and each territory of the United States.
p.001425: (B) For purposes of subsections (b) and (d) of section 2408, the term ‘‘State’’ means each of the several States, the
p.001425: District of Columbia, and the Commonwealth of Puerto Rico.
p.001425: (5) The term ‘‘territory of the United States’’ means each of the following: the Virgin Islands, Guam,
p.001425: American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001425: SEC. 2414. ø300dd–13¿ FUNDING.
p.001425: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making allotments under section 2401(a), there
p.001425: are authorized to be appropriated $100,000,000 for each of the fiscal years 1989 and 1990.
p.001425: (b) AVAILABILITY TO STATES.—Any amounts paid to a State or territory under section 2401(a) shall remain
p.001425: available to the State or territory until the expiration of the 1-year period beginning on the date on
p.001425: which the State or territory receives such amounts.
p.001425: SEC. 2415. ø300dd–14¿ SUNSET.
p.001425: Effective with respect to appropriations made for any period after fiscal year 1990, this part is repealed.
p.001425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001425:
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p.001427: 1427
p.001427: PUBLIC HEALTH SERVICE ACT
p.001427: Sec. 2421
p.001427:
p.001427: PART B—SUBACUTE CARE
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p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001475:
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p.001475: Sec. 2613 PUBLIC HEALTH SERVICE ACT 1476
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p.001475: practicable;
p.001475: (iii) assurances that, in the case of services for in- dividuals residing in rural areas, the applicant consor- tium
p.001475: shall deliver case management services that link available community support services to appropriate specialized
p.001475: medical services; and
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: 1477
p.001477: PUBLIC HEALTH SERVICE ACT
p.001477: Sec. 2613
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p.001477: (iv) assurances that the assessment of service needs and the planning of the delivery of services will
p.001477: include participation by individuals with HIV/AIDS;
p.001477: (C) demonstrates that adequate planning has occurred to meet the special needs of families with HIV/AIDS, in-
p.001477: cluding family centered and youth centered care;
p.001477: (D) demonstrates that the consortium has created a mechanism to evaluate periodically—
p.001477: (i) the success of the consortium in responding to identified needs; and
p.001477: (ii) the cost-effectiveness of the mechanisms em- ployed by the consortium to deliver comprehensive care;
p.001477: (E) demonstrates that the consortium will report to the State the results of the evaluations described
p.001477: in sub- paragraph (D) and shall make available to the State or the Secretary, on request, such data and
p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001507: provider of quality HIV care in the area, under which the entities provide the services.
p.001507: (B) OTHER REQUIREMENTS.—Grantees described in—
p.001507: (i) subparagraphs (A), (D), (E), and (F) of section 2652(a)(1) shall use not less than 50 percent of
p.001507: the amount of such a grant to provide the services de- scribed in subparagraphs (A), (B), (D), and (E) of
p.001507: para- graph (1) directly and on-site or at sites where other primary care services are rendered; and
p.001507: (ii) subparagraphs (B) and (C) of section 2652(a)(1) shall ensure the availability of early intervention serv- ices
p.001507: through a system of linkages to community-based primary care providers, and to establish mechanisms for the
p.001507: referrals described in paragraph (1)(C), and for follow-up concerning such referrals.
p.001507: SEC. 2652. ø300ff–52¿ MINIMUM QUALIFICATIONS OF GRANTEES.
p.001507: (a) ELIGIBLE ENTITIES.—
p.001507: (1) IN GENERAL.—The entities referred to in section 2651(a) are public entities and nonprofit private entities that
p.001507: are—
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
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p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
p.001519: elimination of risk of HIV/AIDS for youth.
p.001519: (2) The applicant will participate in the statewide coordi- nated statement of need under part B (where it has
p.001519: been initi- ated by the public health agency responsible for administering grants under part B) and in revisions of
p.001519: such statement.
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p.001523: SEC. 2689. ø300ff–88¿ DEFINITIONS.
p.001523: For purposes of this title:
p.001523: (1) AIDS.—The term ‘‘AIDS’’ means acquired immune defi- ciency syndrome.
p.001523: (2) CO-OCCURRING CONDITIONS.—The term ‘‘co-occurring conditions’’ means one or more adverse health conditions
p.001523: in an
p.001523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: PUBLIC HEALTH SERVICE ACT
p.001525: Sec. 2689
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p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
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p.001537: 1537
p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
p.001537:
p.001537: taining temporary or permanent injunctive relief with respect to any violation of this part.
p.001537: (b) FACILITATION OF INFORMATION ON VIOLATIONS.—The Sec- retary shall establish an administrative process
p.001537: for encouraging emergency response employees to provide information to the Sec- retary regarding violations
p.001537: of this part. As appropriate, the Sec- retary shall investigate alleged such violations and seek appro-
p.001537: priate injunctive relief.
p.001537: SEC. 2695I. ø300ff–140¿ APPLICABILITY OF PART.
p.001537: This part shall not apply in a State if the chief executive officer of the State certifies to the Secretary that
p.001537: the law of the State is substantially consistent with this part.
p.001537: TITLE XXVII—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
p.001537:
p.001537: PART A—INDIVIDUAL AND GROUP MARKET REFORMS
p.001537: Subpart I—General Reform
p.001537: SEC. 2701. ø300gg¿ FAIR HEALTH INSURANCE PREMIUMS.
p.001537: (a) 1 PROHIBITING DISCRIMINATORY PREMIUM RATES.—
p.001537: (1) IN GENERAL.—With respect to the premium rate charged by a health insurance issuer for health
p.001537: insurance cov- erage offered in the individual or small group market—
p.001537: (A) such rate shall vary with respect to the particular plan or coverage involved only by—
p.001537: (i) whether such plan or coverage covers an indi- vidual or family;
p.001537: (ii) rating area, as established in accordance with paragraph (2);
p.001537: (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with
p.001537: section 2707(c)); and
p.001537: (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
p.001537: (B) such rate shall not vary with respect to the par- ticular plan or coverage involved by any other
p.001537: factor not described in subparagraph (A).
p.001537: (2) RATING AREA.—
p.001537: (A) IN GENERAL.—Each State shall establish 1 or more rating areas within that State for purposes of applying the
p.001537: requirements of this title.
p.001537: (B) SECRETARIAL REVIEW.—The Secretary shall review the rating areas established by each State under subpara- graph
p.001537: (A) to ensure the adequacy of such areas for pur- poses of carrying out the requirements of this
p.001537: title. If the Secretary determines a State’s rating areas are not ade- quate, or that a State does not
p.001537: establish such areas, the Secretary may establish rating areas for that State.
p.001537:
p.001537:
p.001537:
p.001537: January 30, 2020
p.001537: 1 There are no subsections following subsection (a) in section 2701.
p.001537: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001537:
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p.001537: Sec. 2702 PUBLIC HEALTH SERVICE ACT 1538
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p.001537: January 30, 2020
p.001537:
p.001537: (3) PERMISSIBLE AGE BANDS.—The Secretary, in consulta- tion with the National Association of
p.001537: Insurance Commis- sioners, shall define the permissible age bands for rating pur- poses under paragraph
p.001537: (1)(A)(iii).
p.001537: (4) APPLICATION OF VARIATIONS BASED ON AGE OR TOBACCO USE.—With respect to family coverage under a group
p.001537: health plan or health insurance coverage, the rating variations per- mitted under clauses (iii) and (iv) of
p.001537: paragraph (1)(A) shall be applied based on the portion of the premium that is attrib- utable to each
p.001537: family member covered under the plan or cov- erage.
p.001537: (5) SPECIAL RULE FOR LARGE GROUP MARKET.—If a State permits health insurance issuers that offer coverage
p.001537: in the large group market in the State to offer such coverage through the State Exchange (as provided for under
p.001537: section 1312(f)(2)(B) of the Patient Protection and Affordable Care Act), the provi- sions of this
p.001537: subsection shall apply to all coverage offered in such market (other than self-insured group health plans
p.001537: of- fered in such market) in the State.
p.001537: SEC. 2702. ø300gg–1¿ GUARANTEED AVAILABILITY OF COVERAGE.
p.001537: (a) GUARANTEED ISSUANCE OF COVERAGE IN THE INDIVIDUAL AND GROUP MARKET.—Subject to subsections (b)
p.001537: through (e), each health insurance issuer that offers health insurance coverage in the individual or group market in
p.001537: a State must accept every employer and individual in the State that applies for such coverage.
p.001537: (b) ENROLLMENT.—
p.001537: (1) RESTRICTION.—A health insurance issuer described in subsection (a) may restrict enrollment in coverage
p.001537: described in such subsection to open or special enrollment periods.
p.001537: (2) ESTABLISHMENT.—A health insurance issuer described in subsection (a) shall, in accordance with the
p.001537: regulations pro- mulgated under paragraph (3), establish special enrollment pe- riods for qualifying events (under
p.001537: section 603 of the Employee Retirement Income Security Act of 1974).
p.001537: (3) REGULATIONS.—The Secretary shall promulgate regula- tions with respect to enrollment periods under
p.001537: paragraphs (1) and (2).
p.001537: (c) SPECIAL RULES FOR NETWORK PLANS.—
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p.001549: (3) NO GROUP-BASED DISCRIMINATION ON BASIS OF GENETIC INFORMATION.—
p.001549: (A) IN GENERAL.—For purposes of this section, a group health plan, and health insurance issuer offering group or
p.001549: individual health insurance coverage, may not adjust pre- mium or contribution amounts for the group covered
p.001549: under such plan on the basis of genetic information.
p.001549: (B) RULE OF CONSTRUCTION.—Nothing in subpara- graph (A) or in paragraphs (1) and (2) of subsection
p.001549: (d) shall be construed to limit the ability of a health insurance issuer offering group or individual health
p.001549: insurance cov- erage to increase the premium for an employer based on the manifestation of a disease or
p.001549: disorder of an individual who is enrolled in the plan. In such case, the manifestation of a disease or disorder in
p.001549: one individual cannot also be used as genetic information about other group members and to further increase
p.001549: the premium for the employer.
p.001549: (c) GENETIC TESTING.—
p.001549: (1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A group health plan, and a health
p.001549: insurance issuer
p.001549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001551: 1551
p.001551: PUBLIC HEALTH SERVICE ACT
p.001551: Sec. 2705
p.001551:
p.001551: offering health insurance coverage in connection with a group health plan, shall not request or require
p.001551: an individual or a family member of such individual to undergo a genetic test.
p.001551: (2) RULE OF CONSTRUCTION.—Paragraph (1) shall not be construed to limit the authority of a health care
p.001551: professional who is providing health care services to an individual to re- quest that such individual undergo
p.001551: a genetic test.
p.001551: (3) RULE OF CONSTRUCTION REGARDING PAYMENT.—
p.001551: (A) IN GENERAL.—Nothing in paragraph (1) shall be construed to preclude a group health plan, or a health in-
p.001551: surance issuer offering health insurance coverage in con- nection with a group health plan, from
p.001551: obtaining and using the results of a genetic test in making a determina- tion regarding payment (as such term is
p.001551: defined for the purposes of applying the regulations promulgated by the Secretary under part C of title
p.001551: XI of the Social Security Act and section 264 of the Health Insurance Portability and Accountability Act
p.001551: of 1996, as may be revised from time to time) consistent with subsection (a).
p.001551: (B) LIMITATION.—For purposes of subparagraph (A), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request only the minimum
p.001551: amount of in- formation necessary to accomplish the intended purpose.
p.001551: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request, but not require, that a
p.001551: participant or bene- ficiary undergo a genetic test if each of the following conditions is met:
p.001551:
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p.001551:
p.001551: with a group health plan, shall not request, require, or pur- chase genetic information for underwriting
p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
p.001551: surance issuer offering health insurance coverage in connection with a group health plan, shall not request,
p.001551: require, or pur- chase genetic information with respect to any individual prior to such individual’s
p.001551: enrollment under the plan or coverage in connection with such enrollment.
p.001551: (3) INCIDENTAL COLLECTION.—If a group health plan, or a health insurance issuer offering health insurance
p.001551: coverage in connection with a group health plan, obtains genetic informa- tion incidental to the
p.001551: requesting, requiring, or purchasing of other information concerning any individual, such request, re-
p.001551: quirement, or purchase shall not be considered a violation of paragraph (2) if such request, requirement, or
p.001551: purchase is not in violation of paragraph (1).
p.001551: (e) APPLICATION TO ALL PLANS.—The provisions of subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1) and
p.001551: section 2704 with respect to genetic information, shall apply to group health plans and health insurance
p.001551: issuers without regard to section 2735(a).
p.001551: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001551: individual or family member of an individual shall—
p.001551: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001551: infor- mation of any fetus carried by such pregnant woman; and
p.001551: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001551: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001551: (j) 5 PROGRAMS OF HEALTH PROMOTION OR DISEASE PREVEN-
p.001551: TION.—
p.001551: (1) GENERAL PROVISIONS.—
p.001551: (A) GENERAL RULE.—For purposes of subsection (b)(2)(B), a program of health promotion or disease preven-
p.001551: tion (referred to in this subsection as a ‘‘wellness pro- gram’’) shall be a program offered by an
p.001551: employer that is designed to promote health or prevent disease that meets the applicable requirements of this
p.001551: subsection.
p.001551: (B) NO CONDITIONS BASED ON HEALTH STATUS FAC- TOR.—If none of the conditions for obtaining a
p.001551: premium discount or rebate or other reward for participation in a wellness program is based on an
p.001551: individual satisfying a standard that is related to a health status factor, such wellness program shall not
p.001551: violate this section if participa- tion in the program is made available to all similarly situ- ated individuals and
p.001551: the requirements of paragraph (2) are complied with.
p.001551: (C) CONDITIONS BASED ON HEALTH STATUS FACTOR.—If any of the conditions for obtaining a premium discount or
p.001551:
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p.001551: January 30, 2020
p.001551: 5 So in law. There are no subsections (g)–(i).
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001607: (C) Such State law requires, in connection with such coverage for maternity care, that the hospital
p.001607: length of stay for such care is left to the decision of (or required to be made by) the attending
p.001607: provider in consultation with the mother.
p.001607: (2) CONSTRUCTION.—Section 2762(a) shall not be construed as superseding a State law described in paragraph (1).
p.001607: SEC. 2752. ø300gg–52¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 23
p.001607: The provisions of section 2706 shall apply to health insurance coverage offered by a health insurance
p.001607: issuer in the individual market in the same manner as they apply to health insurance cov- erage offered by a
p.001607: health insurance issuer in connection with a group health plan in the small or large group market.
p.001607: SEC. 2753. 24 ø300gg–53¿ PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION.
p.001607: (a) PROHIBITION ON GENETIC INFORMATION AS A CONDITION OF
p.001607: ELIGIBILITY.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market may not establish
p.001607: rules for the eligibility (including continued eligibility) of any individual to enroll in individual
p.001607: health insurance coverage based on genetic information.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from establishing rules for eligibility for an
p.001607: individual to enroll in individual health in- surance coverage based on the manifestation of a disease or
p.001607: disorder in that individual, or in a family member of such indi- vidual where such family member is covered
p.001607: under the policy that covers such individual.
p.001607: (b) PROHIBITION ON GENETIC INFORMATION IN SETTING PRE-
p.001607: MIUM RATES.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001607: adjust
p.001607:
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p.001607: January 30, 2020
p.001607: 23 Section 2752 was added by subsection (b) of section 903 of the Departments of Labor, Health and Human
p.001607: Services, and Education, and Related Agencies Appropriations Act, 1999 (as contained in section 101(f) of division A of
p.001607: Public Law 105–277 (112 Stat. 2681–438)). Subsection
p.001607: (c) of such section 903 concerns effective dates, and paragraph (2) of the subsection provides as follows:
p.001607: ‘‘(2) INDIVIDUAL PLANS.—The amendment made by subsection (b) shall apply with respect to health insurance coverage
p.001607: offered, sold, issued, renewed, in effect, or operated in the indi- vidual market on or after the date of enactment of
p.001607: this Act.’’.
p.001607: The Public Law was enacted October 21, 1998.
p.001607: 24 Another section designated as section 2753 appears at the end of part B. There are details in a footnote regarding
p.001607: its placement at the end.
p.001607: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001607: Sec. 2753 PUBLIC HEALTH SERVICE ACT 1608
p.001607:
p.001607: premium or contribution amounts for an individual on the basis of genetic information concerning the individual
p.001607: or a fam- ily member of the individual.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from adjusting premium or contribution amounts for an
p.001607: individual on the basis of a manifestation of a disease or disorder in that individual, or in a family member of
p.001607: such individual where such family member is covered under the policy that covers such individual. In such case, the
p.001607: manifestation of a disease or disorder in one indi- vidual cannot also be used as genetic information
p.001607: about other individuals covered under the policy issued to such individual and to further increase premiums or
p.001607: contribution amounts.
p.001607: (c) PROHIBITION ON GENETIC INFORMATION AS PREEXISTING CONDITION.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market may not,
p.001607: on the basis of genetic information, impose any preexisting condition exclusion (as defined in section
p.001607: 2701(b)(1)(A)) with respect to such coverage.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from imposing any pre- existing condition
p.001607: exclusion for an individual with respect to health insurance coverage on the basis of a manifestation of a
p.001607: disease or disorder in that individual.
p.001607: (d) GENETIC TESTING.—
p.001607: (1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A health insurance issuer offering health
p.001607: insurance coverage in the individual market shall not request or require an individual or a family member of such
p.001607: individual to undergo a genetic test.
p.001607: (2) RULE OF CONSTRUCTION.—Paragraph (1) shall not be construed to limit the authority of a health care
p.001607: professional who is providing health care services to an individual to re- quest that such individual undergo
p.001607: a genetic test.
p.001607: (3) RULE OF CONSTRUCTION REGARDING PAYMENT.—
p.001607: (A) IN GENERAL.—Nothing in paragraph (1) shall be construed to preclude a health insurance issuer
p.001607: offering health insurance coverage in the individual market from obtaining and using the results of a genetic
p.001607: test in making a determination regarding payment (as such term is de- fined for the purposes of applying the
p.001607: regulations promul- gated by the Secretary under part C of title XI of the So- cial Security Act and
p.001607: section 264 of the Health Insurance Portability and Accountability Act of 1996, as may be re- vised from
p.001607: time to time) consistent with subsection (a) and (c).
p.001607:
p.001607:
p.001607:
p.001607:
p.001607:
p.001607: January 30, 2020
p.001607: (B) LIMITATION.—For purposes of subparagraph (A), a health insurance issuer offering health insurance coverage in
p.001607: the individual market may request only the minimum amount of information necessary to accomplish the in-
p.001607: tended purpose.
p.001607: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001607:
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p.001609: 1609
p.001609: PUBLIC HEALTH SERVICE ACT
p.001609: Sec. 2753
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p.001609: January 30, 2020
p.001609: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a health insurance issuer offering health insurance
p.001609: coverage in the individual market may request, but not require, that an in- dividual or a family member of such
p.001609: individual undergo a ge- netic test if each of the following conditions is met:
p.001609: (A) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal
p.001609: Regula- tions, or equivalent Federal regulations, and any applica- ble State or local law or regulations
p.001609: for the protection of human subjects in research.
p.001609: (B) The issuer clearly indicates to each individual, or in the case of a minor child, to the legal guardian of
p.001609: such child, to whom the request is made that—
p.001609: (i) compliance with the request is voluntary; and
p.001609: (ii) non-compliance will have no effect on enroll- ment status or premium or contribution amounts.
p.001609: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001609: (D) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to
p.001609: the excep- tion provided for under this paragraph, including a de- scription of the activities conducted.
p.001609: (E) The issuer complies with such other conditions as the Secretary may by regulation require for activities
p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
p.001609: information concerning any indi- vidual, such request, requirement, or purchase shall not be considered a
p.001609: violation of paragraph (2) if such request, require- ment, or purchase is not in violation of paragraph (1).
p.001609: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001609: individual or family member of an individual shall—
p.001609: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001609: infor- mation of any fetus carried by such pregnant woman; and
p.001609: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001609: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001609: Sec. 2761 PUBLIC HEALTH SERVICE ACT 1610
p.001609:
p.001609: Subpart 3—General Provisions 25
p.001609: SEC. 2761. ø300gg–61¿ ENFORCEMENT.
p.001609: (a) STATE ENFORCEMENT.—
p.001609: (1) STATE AUTHORITY.—Subject to section 2762, each State may require that health insurance issuers that issue,
p.001609: sell, renew, or offer health insurance coverage in the State in the individual market meet the
p.001609: requirements established under this part with respect to such issuers.
p.001609: (2) FAILURE TO IMPLEMENT REQUIREMENTS.—In the case of a State that fails to substantially enforce the requirements
p.001609: set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the
p.001609: requirements of this part under subsection (b) insofar as they relate to the issuance, sale, renewal, and offering of
p.001609: health insurance coverage in the individual market in such State.
p.001609: (b) SECRETARIAL ENFORCEMENT AUTHORITY.—The Secretary shall have the same authority in relation to enforcement
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p.001613: issuer.
p.001613: (11) PARTICIPANT.—The term ‘‘participant’’ has the mean- ing given such term under section 3(7) of the Employee
p.001613: Retire- ment Income Security Act of 1974.
p.001613: (12) PLACED FOR ADOPTION DEFINED.—The term ‘‘place- ment’’, or being ‘‘placed’’, for adoption, in
p.001613: connection with any
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001615: 1615
p.001615: PUBLIC HEALTH SERVICE ACT
p.001615: Sec. 2791
p.001615:
p.001615: placement for adoption of a child with any person, means the assumption and retention by such person of
p.001615: a legal obligation for total or partial support of such child in anticipation of adop- tion of such child. The
p.001615: child’s placement with such person ter- minates upon the termination of such legal obligation.
p.001615: (13) PLAN SPONSOR.—The term ‘‘plan sponsor’’ has the meaning given such term under section 3(16)(B) of
p.001615: the Em- ployee Retirement Income Security Act of 1974.
p.001615: (14) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, Puerto Rico,
p.001615: the Virgin Is- lands, Guam, American Samoa, and the Northern Mariana Is- lands.
p.001615: (15) FAMILY MEMBER.—The term ‘‘family member’’ means, with respect to any individual—
p.001615: (A) a dependent (as such term is used for purposes of section 2701(f)(2)) of such individual; and
p.001615: (B) any other individual who is a first-degree, second- degree, third-degree, or fourth-degree relative of such indi-
p.001615: vidual or of an individual described in subparagraph (A).
p.001615: (16) GENETIC INFORMATION.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic information’’ means, with respect to any individual, information about—
p.001615: (i) such individual’s genetic tests,
p.001615: (ii) the genetic tests of family members of such in- dividual, and
p.001615: (iii) the manifestation of a disease or disorder in family members of such individual.
p.001615: (B) INCLUSION OF GENETIC SERVICES AND PARTICIPA- TION IN GENETIC RESEARCH.—Such term includes, with re-
p.001615: spect to any individual, any request for, or receipt of, ge- netic services, or participation in
p.001615: clinical research which includes genetic services, by such individual or any family member of such individual.
p.001615: (C) EXCLUSIONS.—The term ‘‘genetic information’’ shall not include information about the sex or age
p.001615: of any individual.
p.001615: (17) GENETIC TEST.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic test’’ means an analysis of human DNA, RNA, chromosomes, proteins, or
p.001615: metabolites, that detects genotypes, mutations, or chromo- somal changes.
p.001615: (B) EXCEPTIONS.—The term ‘‘genetic test’’ does not mean—
p.001615:
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p.001615: (i) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes;
p.001615: or
p.001615: (ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder,
p.001615: or pathological condition that could reasonably be de- tected by a health care professional with
p.001615: appropriate training and expertise in the field of medicine in- volved.
p.001615: (18) GENETIC SERVICES.—The term ‘‘genetic services’’ means—
p.001615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001615: Sec. 2791 PUBLIC HEALTH SERVICE ACT 1616
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p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: 1635
p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
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p.001649: 1649
p.001649: PUBLIC HEALTH SERVICE ACT
p.001649: Sec. 2902
p.001649:
p.001649: (B) prevent physical injury, self-injury, or injury to others.
p.001649: (4) ELIGIBLE STATE AGENCY.—The term ‘‘eligible State agency’’ means a State agency that—
p.001649: (A) administers the State’s program under the Older Americans Act of 1965, administers the State’s
p.001649: program under title XIX of the Social Security Act, or is designated by the Governor of such State to administer
p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
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p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
p.001649: thereby reducing family caregiver strain.
p.001649: (b) AUTHORIZATION.—Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for
p.001649: the pur- poses described in subsection (a) to eligible State agencies for which an application is submitted
p.001649: pursuant to subsection (d).
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001649:
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p.001649: Sec. 2902 PUBLIC HEALTH SERVICE ACT 1650
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p.001649: (c) FEDERAL LIFESPAN APPROACH.—In carrying out this section, the Secretary shall work in cooperation with
p.001649: the National Family Caregiver Support Program of the Administration on Aging and other respite care
p.001649: programs within the Department of Health and Human Services to ensure coordination of respite care
p.001649: services for family caregivers of children and adults with special needs.
p.001649: (d) APPLICATION.—
p.001649: (1) SUBMISSION.—Each Governor desiring the eligible State agency of his or her State to receive a grant or
p.001649: cooperative agreement under this section shall submit an application on behalf of such agency to the
p.001649: Secretary at such time, in such manner, and containing such information as the Secretary shall require.
p.001649: (2) CONTENTS.—Each application submitted under this sec- tion shall include—
p.001649: (A) a description of the eligible State agency’s—
p.001649: (i) ability to work with other State and commu- nity-based agencies;
p.001649: (ii) understanding of respite care and family care- giver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) capacity to ensure meaningful involvement of family members, family caregivers, and care recipi-
p.001649: ents;
p.001649: (B) with respect to the population of family caregivers to whom respite care information or services will be
p.001649: pro- vided or for whom respite care workers and volunteers will be recruited and trained, a description of—
p.001649: (i) the population of family caregivers;
p.001649: (ii) the extent and nature of the respite care needs of that population;
p.001649: (iii) existing respite care services for that popu- lation, including numbers of family caregivers being
p.001649: served and extent of unmet need;
p.001649: (iv) existing methods or systems to coordinate res- pite care information and services to the population at the State
p.001649: and local level and extent of unmet need;
p.001649: (v) how respite care information dissemination and coordination, respite care services, respite care
p.001649: worker and volunteer recruitment and training pro- grams, or training programs for family caregivers that assist
p.001649: such family caregivers in making informed deci- sions about respite care services will be provided using grant or
p.001649: cooperative agreement funds;
p.001649: (vi) a plan for administration, collaboration, and coordination of the proposed respite care
p.001649: activities with other related services or programs offered by public or private, nonprofit entities,
p.001649: including area agencies on aging;
p.001649: (vii) how the population, including family care- givers, care recipients, and relevant public or private
p.001649: agencies, will participate in the planning and imple- mentation of the proposed respite care activities;
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001651: PUBLIC HEALTH SERVICE ACT
p.001651: Sec. 2902
p.001651:
p.001651: (viii) how the proposed respite care activities will make use, to the maximum extent feasible, of other
p.001651: Federal, State, and local funds, programs, contribu- tions, other forms of reimbursements, personnel, and
p.001651: facilities;
p.001651: (ix) respite care services available to family care- givers in the eligible State agency’s State or
p.001651: locality, including unmet needs and how the eligible State agency’s plan for use of funds will improve
p.001651: the coordi- nation and distribution of respite care services for family caregivers of children and adults
p.001651: with special needs;
p.001651: (x) the criteria used to identify family caregivers eligible for respite care services;
p.001651: (xi) how the quality and safety of any respite care services provided will be monitored, including methods to ensure
p.001651: that respite care workers and volunteers are appropriately screened and possess the necessary skills to care
p.001651: for the needs of the care recipient in the absence of the family caregiver; and
p.001651: (xii) the results expected from proposed respite care activities and the procedures to be used for evalu- ating
p.001651: those results;
p.001651: (C) assurances that, where appropriate, the eligible State agency will have a system for maintaining the
p.001651: con- fidentiality of care recipient and family caregiver records; and
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p.001651: (D) a memorandum of agreement regarding the joint responsibility for the eligible State agency’s lifespan
p.001651: res- pite program between—
p.001651: (i) the eligible State agency; and
p.001651: (ii) a public or private nonprofit statewide respite coalition or organization.
p.001651: (e) PRIORITY; CONSIDERATIONS.—When awarding grants or co- operative agreements under this section, the Secretary
p.001651: shall—
p.001651: (1) give priority to eligible State agencies that the Sec- retary determines show the greatest
p.001651: likelihood of imple- menting or enhancing lifespan respite care statewide; and
p.001651: (2) give consideration to eligible State agencies that are building or enhancing the capacity of their
p.001651: long-term care sys- tems to respond to the comprehensive needs, including respite care needs, of their residents.
p.001651: (f) USE OF GRANT OR COOPERATIVE AGREEMENT FUNDS.—
p.001651: (1) IN GENERAL.—
p.001651: (A) REQUIRED USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section shall use all or part of the funds—
p.001651: (i) to develop or enhance lifespan respite care at the State and local levels;
p.001651: (ii) to provide respite care services for family care- givers caring for children or adults;
p.001651: (iii) to train and recruit respite care workers and volunteers;
p.001651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001651: (iv) to provide information to caregivers about available respite and support services; and
p.001651: (v) to assist caregivers in gaining access to such services.
p.001651: (B) OPTIONAL USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section may use part of the funds for—
p.001651: (i) training programs for family caregivers to as- sist such family caregivers in making informed deci-
p.001651: sions about respite care services;
p.001651: (ii) other services essential to the provision of res- pite care as the Secretary may specify; or
p.001651: (iii) training and education for new caregivers.
p.001651: (2) SUBCONTRACTS.—Each eligible State agency awarded a grant or cooperative agreement under this section may
p.001651: carry out the activities described in paragraph (1) directly or by grant to, or contract with, public or
p.001651: private entities.
p.001651: (3) MATCHING FUNDS.—
p.001651: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out under paragraph (1), a
p.001651: condition for the receipt of a grant or cooperative agreement under this section is that the eligible
p.001651: State agency agrees to make available (directly or through donations from public or private entities)
p.001651: non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs.
p.001651: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions required by subparagraph (A) may be
p.001651: in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the
p.001651: Federal Government, or services assisted or subsidized to any sig- nificant extent by the Federal Government,
p.001651: may not be in- cluded in determining the amount of such non-Federal con- tributions.
p.001651: (g) TERM OF GRANTS OR COOPERATIVE AGREEMENTS.—
p.001651: (1) IN GENERAL.—The Secretary shall award grants or co- operative agreements under this section for terms
p.001651: that do not exceed 5 years.
...

p.001663: section 264(c) of the Health Insurance Port- ability and Accountability Act of 1996), including for the
p.001663: segmentation and protection from disclosure of
p.001663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
...

p.001675: third party a copy of such individual’s protected health information pur- suant to the Health Information
p.001675: Portability and Account- ability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations),
p.001675: the Director of the Office for Civil Rights, in consultation with the National Coordi- nator, shall assist
p.001675: individuals and health care providers in understanding a patient’s rights to access and protect per- sonal health
p.001675: information under the Health Insurance Port- ability and Accountability Act of 1996 (Public Law 104– 191),
p.001675: including providing best practices for requesting per- sonal health information in a computable format, including using
p.001675: patient portals or third-party applications and com- mon cases when a provider is permitted to exchange
p.001675: and provide access to health information.
p.001675: (2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the
p.001675: National Coordinator may require that—
p.001675: (A) the certification criteria support—
p.001675: (i) patient access to their electronic health infor- mation, including in a single longitudinal format
p.001675: that is easy to understand, secure, and may be updated automatically;
p.001675: (ii) the patient’s ability to electronically commu- nicate patient-reported information (such as family
p.001675: history and medical history); and
p.001675: (iii) patient access to their personal electronic health information for research at the option of the pa-
p.001675: tient; and
p.001675: (B) the HIT Advisory Committee develop and prioritize standards, implementation specifications,
p.001675: and certification criteria required to help support patient ac- cess to electronic health information, patient
p.001675: usability, and support for technologies that offer patients access to their electronic health information in
p.001675: a single, longitudinal for-
p.001675: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001675:
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p.001675: Sec. 3009A PUBLIC HEALTH SERVICE ACT 1676
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p.001675: January 30, 2020
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p.001713: C:\XML\PHSA.BEL HOUSEP
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p.001713: Sec. 3311 PUBLIC HEALTH SERVICE ACT 1714
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p.001713: January 30, 2020
p.001713:
p.001713: (2) CURRENT ELIGIBILITY CRITERIA.—The eligibility criteria described in this paragraph for an individual is
p.001713: that the indi- vidual is described in any of the following categories:
p.001713: (A) FIREFIGHTERS AND RELATED PERSONNEL.—The in- dividual—
p.001713: (i) was a member of the Fire Department of New York City (whether fire or emergency personnel, active or
p.001713: retired) who participated at least one day in the rescue and recovery effort at any of the former
p.001713: World Trade Center sites (including Ground Zero, Staten Is- land Landfill, and the New York City Chief
p.001713: Medical Examiner’s Office) for any time during the period be- ginning on September 11, 2001, and ending
p.001713: on July 31, 2002; or
p.001713: (ii)(I) is a surviving immediate family member of an individual who was a member of the Fire Depart-
p.001713: ment of New York City (whether fire or emergency personnel, active or retired) and was killed at the
p.001713: World Trade site on September 11, 2001; and
p.001713: (II) received any treatment for a WTC-related health condition described in section 3312(a)(1)(A)(ii)
p.001713: (relating to mental health conditions) on or before Sep- tember 1, 2008.
p.001713: (B) LAW ENFORCEMENT OFFICERS AND WTC RESCUE, RE- COVERY, AND CLEANUP WORKERS.—The individual—
p.001713: (i) worked or volunteered onsite in rescue, recov- ery, debris cleanup, or related support services
p.001713: in lower Manhattan (south of Canal St.), the Staten Is- land Landfill, or the barge loading piers, for
p.001713: at least 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001, for at
p.001713: least
p.001713: 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, or for at least
p.001713: 80 hours during the period beginning on Sep- tember 11, 2001, and ending on July 31, 2002;
p.001713: (ii)(I) was a member of the Police Department of New York City (whether active or retired) or a mem-
p.001713: ber of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or
p.001713: re- tired) who participated onsite in rescue, recovery, de- bris cleanup, or related services in lower
...

p.001717: WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to,
p.001717: or causing the condition, as determined under paragraph (2); and
p.001717: (B) is included in the applicable list of WTC-related health conditions or—
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001717:
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p.001717:
p.001717: Sec. 3312 PUBLIC HEALTH SERVICE ACT 1718
p.001717: (i) with respect to a WTC responder, is provided certification of coverage under subsection (b)(2)(B)(iii); or
p.001717:
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p.001717: January 30, 2020
p.001717: (ii) with respect to a screening-eligible WTC sur- vivor or certified-eligible WTC survivor, is provided
p.001717: certification of coverage under subsection (b)(2)(B)(iii), as applied under section 3322(a).
p.001717: In the case of a WTC responder described in section 3311(a)(2)(A)(ii) (relating to a
p.001717: surviving immediate family member of a firefighter), such term does not include an illness or health condition
p.001717: described in subparagraph (A)(i).
p.001717: (2) DETERMINATION.—The determination under paragraph
p.001717: (1) or subsection (b) of whether the September 11, 2001, ter- rorist attacks were substantially likely
p.001717: to be a significant fac- tor in aggravating, contributing to, or causing an individual’s illness or
p.001717: health condition shall be made based on an assess- ment of the following:
p.001717: (A) The individual’s exposure to airborne toxins, any other hazard, or any other adverse condition
p.001717: resulting from the terrorist attacks. Such exposure shall be—
p.001717: (i) evaluated and characterized through the use of a standardized, population-appropriate questionnaire approved by
p.001717: the Director of the National Institute for Occupational Safety and Health; and
p.001717: (ii) assessed and documented by a medical profes- sional with experience in treating or diagnosing health conditions
p.001717: included on the list of WTC-related health conditions.
p.001717: (B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall be—
p.001717: (i) assessed through the use of a standardized, population-appropriate medical questionnaire ap- proved
p.001717: by the Director of the National Institute for Oc- cupational Safety and Health and a medical examina- tion; and
p.001717: (ii) diagnosed and documented by a medical pro- fessional described in subparagraph (A)(ii).
p.001717: (3) LIST OF HEALTH CONDITIONS FOR WTC RESPONDERS.— The list of health conditions for WTC responders
p.001717: consists of the following:
...

p.001737: (5) AMOUNTS TO REMAIN AVAILABLE UNTIL EXPENDED.— Amounts deposited into the Fund under this
p.001737: subsection, in- cluding amounts deposited under paragraph (2) as in effect on the day before the date of
p.001737: enactment of the James Zadroga 9/ 11 Health and Compensation Reauthorization Act, for a fiscal year shall
p.001737: remain available, for the purposes described in this title, until expended for such fiscal year and any
p.001737: subsequent fiscal year through fiscal year 2090.
p.001737: (b) MANDATORY FUNDS FOR MONITORING, INITIAL HEALTH EVALUATIONS, TREATMENT, AND CLAIMS PROCESSING.—
p.001737: (1) IN GENERAL.—The amounts deposited into the Fund under subsection (a)(2) shall be available, without
p.001737: further ap- propriation, consistent with paragraph (2) and subsection (c), to carry out subtitle B and
p.001737: sections 3301(e), 3301(f), 3302(a), 3302(b), 3303, 3304, 3305(a)(1), 3305(a)(2), 3305(c), 3341, and 3342.
p.001737: (2) LIMITATION ON MANDATORY FUNDING.—This title does not establish any Federal obligation for payment of
p.001737: amounts in excess of the amounts available from the Fund for such pur- pose.
p.001737: (3) LIMITATION ON AUTHORIZATION FOR FURTHER APPRO- PRIATIONS.—This title does not establish any
p.001737: authorization for appropriation of amounts in excess of the amounts available from the Fund under paragraph
p.001737: (1).
p.001737: (c) LIMITS ON SPENDING FOR CERTAIN PURPOSES.—Of the amounts made available under subsection
p.001737: (b)(1), not more than each of the following amounts may be available for each of the fol- lowing purposes:
p.001737: (1) SURVIVING IMMEDIATE FAMILY MEMBERS OF FIRE- FIGHTERS.—For the purposes of carrying out subtitle B
p.001737: with re- spect to WTC responders described in section 3311(a)(2)(A)(ii)—
p.001737: (A) for fiscal year 2016, the amount determined for such fiscal year under subparagraph (C) as in effect on the
p.001737: day before the date of enactment of the James Zadroga 9/ 11 Health and Compensation Reauthorization Act; and
p.001737: (B) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001737: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001737: United States city average) as estimated by the Secretary for the 12- month period ending with March of the
p.001737: previous year.
p.001737: (2) WTC HEALTH PROGRAM SCIENTIFIC/TECHNICAL ADVISORY COMMITTEE.—For the purpose of carrying out section 3302(a)—
p.001737: (A) for fiscal year 2016, $200,000; 1
p.001737: (B) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001737: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001737: United States
p.001737:
p.001737:
p.001737:
p.001737: January 30, 2020
p.001737: 1 So in law. Probably should read ‘‘; and’’.
p.001737:
p.001737: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001739: 1739
p.001739: PUBLIC HEALTH SERVICE ACT
p.001739: Sec. 3351
p.001739:
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p.000125: epidemiological activities regarding neural tube defects.
p.000125: (b) CONSULTATIONS WITH STATES AND PRIVATE ENTITIES.—In carrying out subsection (a), the Secretary shall
p.000125: consult with the States and with other appropriate public or private entities, includ- ing national nonprofit
p.000125: private organizations, health professionals, and providers of health insurance and health plans.
p.000125: (c) TECHNICAL ASSISTANCE.—The Secretary may (directly or through grants or contracts) provide technical
p.000125: assistance to public and nonprofit private entities in carrying out the activities de- scribed in subsection
p.000125: (a).
p.000125: (d) EVALUATIONS.—The Secretary shall (directly or through grants or contracts) provide for the evaluation
p.000125: of activities under subsection (a) in order to determine the extent to which such activi- ties have been effective in
p.000125: carrying out the purposes of the program under such subsection, including the effects on various demo-
p.000125: graphic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge
p.000125: and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include
p.000125: complete and timely monitoring of infants who are born with neural tube defects.
p.000125: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000125: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
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p.000125: SAFE MOTHERHOOD
p.000125: SEC. 317K. ø247b–12¿ (a) SURVEILLANCE.—
p.000125: (1) PURPOSE.—The purposes of this subsection are to es- tablish or continue a Federal initiative to
p.000125: support State and tribal maternal mortality review committees, to improve data collection and reporting around
p.000125: maternal mortality, and to de- velop or support surveillance systems at the local, State, and national level
p.000125: to better understand the burden of maternal complications and mortality and to decrease the disparities
p.000125: among populations at risk of death and severe complications from pregnancy.
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000125: (A) The Secretary may continue and improve activities related to a national maternal mortality data collection
p.000125: and surveillance program to identify and support the re- view of pregnancy-associated deaths and
p.000125: pregnancy-related deaths that occur during, or within 1 year following, preg- nancy.
p.000125: (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and
p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
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Health / Physically Disabled

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p.000017: (A) who is a health care worker, law enforcement offi- cer, firefighter, security personnel, emergency medical per-
p.000017: sonnel, other public safety personnel, or support personnel for such occupational specialities;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 261 PUBLIC HEALTH SERVICE ACT 60
p.000017:
p.000017: (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human
p.000017: Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary;
p.000017: (C) who has volunteered and been selected to be a member of a smallpox emergency response plan
p.000017: described in subparagraph (B) prior to the time at which the Sec- retary publicly announces that an
p.000017: active case of smallpox has been identified either within or outside of the United States; and
p.000017: (D) to whom a smallpox vaccine is administered pur- suant to such approved plan during the effective period of
p.000017: the Declaration (including the portion of such period before the enactment of this part).
p.000017: (3) COVERED INJURY.—The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other
p.000017: than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures
p.000017: established under sec- tion 262, to have been sustained by an individual as the direct result of—
p.000017: (A) administration to the individual of a covered coun- termeasure during the effective period of the
p.000017: Declaration; or
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p.000017: January 30, 2020
p.000017: (B) accidental vaccinia inoculation of the individual in circumstances in which—
p.000017: (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after
p.000017: the end of such period;
p.000017: (ii) smallpox vaccine has not been administered to the individual; and
p.000017: (iii) the individual has been in contact with an in- dividual who is (or who was accidentally inoculated by) a
p.000017: covered individual.
p.000017: (4) DECLARATION.—The term ‘‘Declaration’’ means the Dec- laration Regarding Administration of Smallpox
p.000017: Counter- measures issued by the Secretary on January 24, 2003, and published in the Federal Register on
p.000017: January 28, 2003.
p.000017: (5) EFFECTIVE PERIOD OF THE DECLARATION.—The term ‘‘ef- fective period of the Declaration’’ means the
p.000017: effective period specified in the Declaration, unless extended by the Secretary.
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p.000017: health statistical and epidemiological activities, and all research, evaluations, and dem- onstrations
p.000017: respecting the assessment of health care technology un- dertaken and supported through units of the Department of
p.000017: Health and Human Services. To the maximum extent feasible such coordi- nation shall be carried out through the Agency
p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
p.000017: statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and
p.000017: demonstrations respecting the assessment of health care technology authorized by this Act through the Agency
p.000017: for Health Care Policy and Research and the National Center for Health Sta- tistics.
p.000017:
p.000017: NATIONAL CENTER FOR HEALTH STATISTICS
p.000017: SEC. 306. 3 ø242k¿ (a) There is established in the Department of Health and Human Services the National Center
p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
p.000017: acute and chronic ill- nesses, and infant and maternal morbidity and mortality,
p.000017: (B) the impact of illness and disability of the popu- lation on the economy of the United States and
p.000017: on other aspects of the well-being of its population (or of such groupings),
p.000017: (C) environmental, social, and other health hazards,
p.000017: (D) determinants of health,
p.000017: (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty
p.000017: and type of practice and the supply of services by hospitals, ex- tended care facilities, home health agencies,
p.000017: and other health institutions,
p.000017: (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types
p.000017: of practice of the health professionals providing such serv- ices, and (ii) services of hospitals,
p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities
p.000017: shall be made in such amounts as may be provided in such agreement.
p.000017: (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health
p.000017: data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation
p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
p.000017: necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data
p.000017: on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific
p.000017: Islanders with significant representation in the State or registration area. Each State or registration area shall
p.000017: be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and
p.000017: transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such
p.000017: data.
p.000017: (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general
p.000017: health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to
p.000017: be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and
p.000017: accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations,
p.000017: and the relationship between de- mographic and socioeconomic characteristics and health character- istics.
p.000017: (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use
p.000017: in such activities of statistics collected or compiled by the Center.
p.000017: (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section,
p.000017: the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and
p.000017: Human Services by—
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 4 So in law. Probably should be capitalized.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 306 PUBLIC HEALTH SERVICE ACT 82
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p.000215: section 319L.
p.000215: (h) DEFINITIONS.—In this section:
p.000215: (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a).
p.000215: (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any
p.000215: appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation
p.000215: made available pur- suant to subsection (g)(1).
p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000215:
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p.000217: PUBLIC HEALTH SERVICE ACT
p.000217: Sec. 319F–3
p.000217:
p.000217: (1) IN GENERAL.—Subject to the other provisions of this section, a covered person shall be immune from suit and
p.000217: liabil- ity under Federal and State law with respect to all claims for loss caused by, arising out of,
p.000217: relating to, or resulting from the administration to or the use by an individual of a covered countermeasure
p.000217: if a declaration under subsection (b) has been issued with respect to such countermeasure.
p.000217: (2) SCOPE OF CLAIMS FOR LOSS.—
p.000217: (A) LOSS.—For purposes of this section, the term ‘‘loss’’ means any type of loss, including—
p.000217: (i) death;
p.000217: (ii) physical, mental, or emotional injury, illness, disability, or condition;
p.000217: (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need
p.000217: for medical monitoring; and
p.000217: (iv) loss of or damage to property, including busi- ness interruption loss.
p.000217: Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or
p.000217: discovery of the loss described in the clause.
p.000217: (B) SCOPE.—The immunity under paragraph (1) ap- plies to any claim for loss that has a causal
p.000217: relationship with the administration to or use by an individual of a cov- ered countermeasure, including a causal
p.000217: relationship with the design, development, clinical testing or investigation, manufacture, labeling,
p.000217: distribution, formulation, pack- aging, marketing, promotion, sale, purchase, donation, dis- pensing, prescribing,
p.000217: administration, licensing, or use of such countermeasure.
p.000217: (3) CERTAIN CONDITIONS.—Subject to the other provisions of this section, immunity under paragraph (1)
p.000217: with respect to a covered countermeasure applies only if—
p.000217: (A) the countermeasure was administered or used dur- ing the effective period of the declaration that was
p.000217: issued under subsection (b) with respect to the countermeasure;
p.000217: (B) the countermeasure was administered or used for the category or categories of diseases, health conditions,
p.000217: or threats to health specified in the declaration; and
p.000217: (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to
p.000217: the administration or use of the countermeasure, the counter- measure was administered to or used by an
p.000217: individual who—
p.000217:
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p.000297: urban commuting area code as set forth by the Office of Manage- ment and Budget).
p.000297: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section to an entity unless the entity agrees
p.000297: that the entity will make available (directly or through contributions from other public or private entities)
p.000297: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of
p.000297: the amount received under the grant.
p.000297: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000297: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section such sums as may be
p.000297: necessary for each of fiscal years 2019 through 2023.
p.000297: (2) ADMINISTRATIVE COSTS.—The Secretary may use not more than 10 percent of the amount appropriated under para-
p.000297: graph (1) for a fiscal year for the administrative expenses of carrying out this section.
p.000297: SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
p.000297: (a) DEFINITIONS.—In this section:
p.000297: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider
p.000297: network that of- fers services that include mental health services provided by qualified mental health
p.000297: providers.
p.000297: (2) QUALIFIED MENTAL HEALTH PROFESSIONALS.—The term ‘‘qualified mental health professionals’’ refers to
p.000297: providers of mental health services reimbursed under the medicare pro- gram carried out under title XVIII
p.000297: of the Social Security Act (42 U.S.C. 1395 et seq.) who have additional training in the treatment of
p.000297: mental illness in children and adolescents or who have additional training in the treatment of mental illness
p.000297: in the elderly.
p.000297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000297:
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p.000299: PUBLIC HEALTH SERVICE ACT
p.000299: Sec. 330K
p.000299:
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p.000299: January 30, 2020
p.000299: (3) SPECIAL POPULATIONS.—The term ‘‘special populations’’ refers to the following 2 distinct groups:
p.000299: (A) Children and adolescents in mental health under- served rural areas or in mental health underserved urban
p.000299: areas.
p.000299: (B) Elderly individuals located in long-term care facili- ties in mental health underserved rural or urban areas.
p.000299: (4) TELEHEALTH.—The term ‘‘telehealth’’ means the use of electronic information and telecommunications
p.000299: technologies to support long distance clinical health care, patient and profes- sional health-related
p.000299: education, public health, and health ad- ministration.
p.000299: (b) PROGRAM AUTHORIZED.—
p.000299: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Office for the Advancement of Telehealth
p.000299: of the Health Resources and Services Administration, shall award grants to eligible entities to establish
p.000299: demonstration projects for the provision of mental health services to special popu- lations as delivered
p.000299: remotely by qualified mental health profes- sionals using telehealth and for the provision of education re-
p.000299: garding mental illness as delivered remotely by qualified men- tal health professionals using telehealth.
p.000299: (2) POPULATIONS SERVED.—The Secretary shall award the grants under paragraph (1) in a manner that
p.000299: distributes the grants so as to serve equitably the populations described in subparagraphs (A) and (B) of
p.000299: subsection (a)(3).
p.000299: (c) USE OF FUNDS.—
p.000299: (1) IN GENERAL.—An eligible entity that receives a grant under this section shall use the grant funds—
p.000299: (A) for the populations described in subsection (a)(3)(A)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, as delivered
p.000299: remotely by qualified mental health professionals using telehealth; and
p.000299: (ii) to collaborate with local public health entities to provide the mental health services; and
p.000299: (B) for the populations described in subsection (a)(3)(B)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, in long-term care
p.000299: facilities as delivered remotely by qualified men- tal health professionals using telehealth; and
p.000299: (ii) to collaborate with local public health entities to provide the mental health services.
p.000299: (2) OTHER USES.—An eligible entity that receives a grant under this section may also use the grant funds to—
p.000299: (A) pay telecommunications costs; and
p.000299: (B) pay qualified mental health professionals on a rea- sonable cost basis as determined by the Secretary for serv-
p.000299: ices rendered.
p.000299: (3) PROHIBITED USES.—An eligible entity that receives a grant under this section shall not use the grant funds
p.000299: to—
p.000299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000299:
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p.000299: Sec. 330L PUBLIC HEALTH SERVICE ACT 300
p.000299:
p.000299: (A) purchase or install transmission equipment (other than such equipment used by qualified mental health pro-
p.000299: fessionals to deliver mental health services using tele- health under the project involved); or
p.000299: (B) build upon or acquire real property.
p.000299: (d) EQUITABLE DISTRIBUTION.—In awarding grants under this section, the Secretary shall ensure, to the greatest
p.000299: extent possible, that such grants are equitably distributed among geographical re- gions of the United States.
p.000299: (e) APPLICATION.—An entity that desires a grant under this section shall submit an application to the
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p.000341: immediately preceding fiscal year, the State has complied with each of the agreements made by the State under
p.000341: this section.
p.000341: (2) REDUCTION IN GRANT RELATIVE TO NUMBER OF BREACHED CONTRACTS.—
p.000341: (A) Before making a grant under subsection (a) to a State for a fiscal year, the Secretary shall
p.000341: determine the number of contracts provided by the State under para- graph (2) of such subsection with
p.000341: respect to which there has been an initial breach by the health professionals in- volved during the
p.000341: fiscal year preceding the fiscal year for which the State is applying to receive the grant.
p.000341: (B) Subject to paragraph (3), in the case of a State with 1 or more initial breaches for purposes of
p.000341: subpara- graph (A), the Secretary shall reduce the amount of a grant under subsection (a) to the State
p.000341: for the fiscal year involved by an amount equal to the sum of the expendi- tures of Federal funds made
p.000341: regarding the contracts in- volved and an amount representing interest on the amount of such expenditures,
p.000341: determined with respect to each con- tract on the basis of the maximum legal rate prevailing for loans made during the
p.000341: time amounts were paid under the contract, as determined by the Treasurer of the United States.
p.000341: (3) WAIVER REGARDING REDUCTION IN GRANT.—The Sec- retary may waive the requirement established in
p.000341: paragraph (2)(B) with respect to the initial breach of a contract if the Sec- retary determines that such breach
p.000341: by the health professional involved was attributable solely to the professional having a serious illness.
p.000341: (h) DEFINITIONS.—For purposes of this section, the term ‘‘State’’ means each of the 50 States, the
p.000341: District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands,
p.000341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000341:
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p.000343: PUBLIC HEALTH SERVICE ACT
p.000343: Sec. 338J
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p.000343: Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the Northern Mariana Islands.
p.000343: (i) AUTHORIZATION OF APPROPRIATIONS.—
p.000343: (1) IN GENERAL.—For the purpose of making grants under subsection (a), there are authorized to be
p.000343: appropriated
p.000343: $12,000,000 for fiscal year 2008, and such sums as may be nec- essary for each of fiscal years 2009 through 2012.
p.000343: (2) AVAILABILITY.—Amounts appropriated under paragraph
p.000343: (1) shall remain available until expended.
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p.000401: Sec. 351A PUBLIC HEALTH SERVICE ACT 402
p.000401:
p.000401: (2) DATE OF APPROVAL.—For purposes of this section, with respect to an application described in paragraph (1),
p.000401: references to the date of approval of such application, or licensure of the product subject to such
p.000401: application, shall mean the later of—
p.000401: (A) the date an application is approved under sub- section (a); or
p.000401: (B) the date of issuance of the interim final rule con- trolling the biological product.
p.000401: SEC. 351A. ø262a¿ ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS. 60
p.000401: (a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (A) IN GENERAL.—The Secretary shall by regulation establish and maintain a list of each biological agent
p.000401: and each toxin that has the potential to pose a severe threat to public health and safety.
p.000401: (B) CRITERIA.—In determining whether to include an agent or toxin on the list under subparagraph (A), the Sec-
p.000401: retary shall—
p.000401: (i) consider—
p.000401: (I) the effect on human health of exposure to the agent or toxin;
p.000401: (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is
p.000401: transferred to humans;
p.000401: (III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent
p.000401: any illness resulting from infection by the agent or toxin; and
p.000401: (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary
p.000401: considers appropriate; and
p.000401: (ii) consult with appropriate Federal departments and agencies and with scientific experts representing
p.000401: appropriate professional groups, including groups with pediatric expertise.
p.000401: (2) BIENNIAL REVIEW.—The Secretary shall review and re- publish the list under paragraph (1) biennially,
p.000401: or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
p.000401: (b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX-
p.000401: INS.—The Secretary shall by regulation provide for—
p.000401: (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including
p.000401: measures to ensure—
p.000401: (A) proper training and appropriate skills to handle such agents and toxins; and
p.000401:
p.000401:
p.000401:
p.000401:
p.000401:
p.000401:
p.000401: January 30, 2020
p.000401: 60 A program is carried out by the Secretary of Agriculture with respect to each biological agent and
p.000401: each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant
p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
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p.000565: (B) required to be so licensed, registered, or certified but that is exempted by other statute or regulation.
p.000565: (k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $50,000,000
p.000565: for the 5- fiscal year period beginning with fiscal year 2011.
p.000565: (l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO TORT LITIGATION.—Nothing in this section shall
p.000565: be construed to limit any prior, current, or future efforts of any State to establish any alternative to
p.000565: tort litigation.
p.000565: (m) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as limiting states’ authority over or
p.000565: responsibility for their state justice systems.
p.000565: SEC. 399V–5. ø280g–16¿ FOOD SAFETY INTEGRATED CENTERS OF EX- CELLENCE.
p.000565: (a) IN GENERAL.—Not later than 1 year after the date of enact- ment of the FDA Food Safety Modernization Act,
p.000565: the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation
p.000565: with the working group described in subsection (b)(2), shall designate 5 Integrated Food Safety Cen- ters
p.000565: of Excellence (referred to in this section as the ‘‘Centers of Ex- cellence’’) to serve as resources for Federal,
p.000565: State, and local public health professionals to respond to foodborne illness outbreaks. The Centers of Excellence
p.000565: shall be headquartered at selected State health departments.
p.000565: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000565:
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p.000567: PUBLIC HEALTH SERVICE ACT
p.000567: Sec. 399V–5
p.000567:
p.000567: (b) SELECTION OF CENTERS OF EXCELLENCE.—
p.000567: (1) ELIGIBLE ENTITIES.—To be eligible to be designated as a Center of Excellence under subsection
p.000567: (a), an entity shall—
p.000567: (A) be a State health department;
p.000567: (B) partner with 1 or more institutions of higher edu- cation that have demonstrated knowledge, expertise, and
p.000567: meaningful experience with regional or national food pro- duction, processing, and distribution, as well as
p.000567: leadership in the laboratory, epidemiological, and environmental de- tection and investigation of foodborne
p.000567: illness; and
p.000567: (C) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require.
p.000567: (2) WORKING GROUP.—Not later than 180 days after the date of enactment of the FDA Food Safety
p.000567: Modernization Act, the Secretary shall establish a diverse working group of ex- perts and stakeholders from
p.000567: Federal, State, and local food safe- ty and health agencies, the food industry, including food retail- ers and food
p.000567: manufacturers, consumer organizations, and aca- demia to make recommendations to the Secretary regarding
p.000567: designations of the Centers of Excellence.
p.000567: (3) ADDITIONAL CENTERS OF EXCELLENCE.—The Secretary may designate eligible entities to be regional Food Safety
p.000567: Cen- ters of Excellence, in addition to the 5 Centers designated under subsection (a).
p.000567: (c) ACTIVITIES.—Under the leadership of the Director of the Centers for Disease Control and Prevention,
p.000567: each Center of Excel- lence shall be based out of a selected State health department, which shall
p.000567: provide assistance to other regional, State, and local departments of health through activities that include—
p.000567: (1) providing resources, including timely information con- cerning symptoms and tests, for frontline health
p.000567: professionals interviewing individuals as part of routine surveillance and outbreak investigations;
p.000567: (2) providing analysis of the timeliness and effectiveness of foodborne disease surveillance and outbreak response
p.000567: activi- ties;
p.000567: (3) providing training for epidemiological and environ- mental investigation of foodborne illness,
p.000567: including suggestions for streamlining and standardizing the investigation process;
p.000567: (4) establishing fellowships, stipends, and scholarships to train future epidemiological and food-safety leaders
p.000567: and to ad- dress critical workforce shortages;
p.000567: (5) training and coordinating State and local personnel;
p.000567: (6) strengthening capacity to participate in existing or new foodborne illness surveillance and environmental
p.000567: assessment information systems; and
p.000567: (7) conducting research and outreach activities focused on increasing prevention, communication, and
p.000567: education regard- ing food safety.
p.000567: (d) REPORT TO CONGRESS.—Not later than 2 years after the date of enactment of the FDA Food Safety
p.000567: Modernization Act, the Secretary shall submit to Congress a report that—
p.000567: (1) describes the effectiveness of the Centers of Excellence;
p.000567:
p.000567:
p.000567: January 30, 2020
p.000567: and
p.000567:
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000567:
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p.000567:
p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
p.000567: (2) PARTICULAR CANCER.—The term ‘‘particular cancer’’ means one specific type of cancer or a type of cancers
p.000567: scientif- ically proven to have the same cause.
p.000567: (3) POPULATION GROUP.—The term ‘‘population group’’ means a group, for purposes of calculating cancer
p.000567: rates, de- fined by factors such as race, ethnicity, age, or gender.
p.000567: (b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUS-
p.000567: TERS.—
p.000567: (1) DEVELOPMENT OF CRITERIA.—The Secretary shall de- velop criteria for the designation of potential
p.000567: cancer clusters.
p.000567: (2) REQUIREMENTS.—The criteria developed under para- graph (1) shall consider, as appropriate—
p.000567: (A) a standard for cancer cluster identification and re- porting protocols used to determine when cancer incidence is
p.000567: greater than would be typically observed;
p.000567: (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same
p.000567: type of cancer, or types of cancers;
...

p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000575:
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p.000575:
p.000575: Sec. 399Z–2 PUBLIC HEALTH SERVICE ACT 576
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p.000575:
p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
p.000575: (A) is at risk for, shows early signs of, or has been di- agnosed with a mental illness, including a serious
p.000575: emo- tional disturbance; and
p.000575: (B) may benefit from infant and early childhood inter- vention or treatment programs or specialized preschool or
p.000575: elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise
p.000575: but would benefit from further applied development.
p.000575: (2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a human services agency or nonprofit institution that—
p.000575: (A) employs licensed mental health professionals who have specialized training and experience in infant
p.000575: and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the
p.000575: appropriate State agency, as applicable, to provide for children from in- fancy to 12 years of age mental health
p.000575: promotion, inter- vention, or treatment services; and
p.000575: (B) provides services or programs described in sub- section (a) that are evidence-based or that have
p.000575: been sci- entifically demonstrated to show promise but would benefit from further applied development.
p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000575:
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
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p.000577: January 30, 2020
p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
...

p.000751: (d) DEFINITION.—For purposes of this section, the term ‘‘pharmacotherapeutics’’ means medications used to
p.000751: treat the symp- toms and disease of drug abuse, including medications to—
p.000751: (1) block the effects of abused drugs;
p.000751: (2) reduce the craving for abused drugs;
p.000751: (3) moderate or eliminate withdrawal symptoms;
p.000751: (4) block or reverse the toxic effect of abused drugs; or
p.000751: (5) prevent relapse in persons who have been detoxified from drugs of abuse.
p.000751: Subpart 16—National Institute of Mental Health
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p.000751:
p.000751: PURPOSE OF INSTITUTE
p.000751: SEC. 464R. ø285p¿ (a) IN GENERAL.—The general purpose of the National Institute of Mental Health
p.000751: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of bio- medical
p.000751: and behavioral research, health services research, research training, and health information dissemination with respect
p.000751: to the cause, diagnosis, treatment, control and prevention of mental ill- ness.
p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
...

p.000825: (3) The Center for Mental Health Services.
p.000825: (c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SEC-
p.000825: RETARY.—
p.000825: (1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant
p.000825: Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘‘Assistant
p.000825: Secretary’’) who shall be ap- pointed by the President, by and with the advice and consent of the Senate.
p.000825: (2) DEPUTY ASSISTANT SECRETARY.—The Assistant Sec- retary, with the approval of the Secretary, may appoint
p.000825: a Dep- uty Assistant Secretary and may employ and prescribe the functions of such officers and employees,
p.000825: including attorneys, as are necessary to administer the activities to be carried out through the
p.000825: Administration.
p.000825: (d) AUTHORITIES.—The Secretary, acting through the Assistant Secretary, shall—
p.000825: (1) supervise the functions of the Centers of the Adminis- tration in order to assure that the
p.000825: programs carried out through each such Center receive appropriate and equitable support and that there is
p.000825: cooperation among the Centers in the implementation of such programs;
p.000825: (2) establish and implement, through the respective Cen- ters, a comprehensive program to improve the
p.000825: provision of treatment and related services to individuals with respect to substance use disorders and mental
p.000825: illness and to improve pre- vention services, promote mental health and protect the legal rights of individuals
p.000825: with mental illnesses and individuals with substance use disorders;
p.000825: (3) carry out the administrative and financial manage- ment, policy development and planning, evaluation,
p.000825: knowledge dissemination, and public information functions that are re- quired for the implementation of this
p.000825: title;
p.000825: (4) assure that the Administration conduct and coordinate demonstration projects, evaluations, and service system
p.000825: assess- ments and other activities necessary to improve the avail- ability and quality of treatment,
p.000825: prevention and related serv- ices;
p.000825: (5) support activities that will improve the provision of treatment, prevention and related services, including
p.000825: the devel-
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000825:
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p.000825: Sec. 501 PUBLIC HEALTH SERVICE ACT 826
p.000825:
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p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
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p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000831:
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p.000831:
p.000831: Sec. 501 PUBLIC HEALTH SERVICE ACT 832
p.000831:
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p.000831: January 30, 2020
p.000831:
p.000831: (B) assist the Assistant Secretary in the evaluation, organization, integration, and coordination of programs
p.000831: op- erated by the Administration;
p.000831: (C) promote evidence-based and promising best prac- tices, including culturally and linguistically
p.000831: appropriate practices, as appropriate, for the prevention and treatment of, and recovery from, mental and substance use
p.000831: disorders, including serious mental illness and serious emotional dis- turbances;
p.000831: (D) participate in regular strategic planning with the Administration;
p.000831: (E) coordinate with the Assistant Secretary for Plan- ning and Evaluation to assess the use of
p.000831: performance metrics to evaluate activities within the Administration re- lated to mental and substance use disorders;
p.000831: and
p.000831: (F) coordinate with the Assistant Secretary to ensure mental and substance use disorders grant programs within
p.000831: the Administration consistently utilize appropriate per- formance metrics and evaluation designs.
p.000831: (h) SERVICES OF EXPERTS.—
p.000831: (1) IN GENERAL.—The Assistant Secretary may obtain (in accordance with section 3109 of title 5, United States
p.000831: Code, but without regard to the limitation in such section on the number of days or the period of service) the
p.000831: services of not more than 20 experts or consultants who have professional qualifications. Such experts and
p.000831: consultants shall be obtained for the Admin- istration and for each of its agencies.
p.000831: (2) COMPENSATION AND EXPENSES.—
p.000831: (A) Experts and consultants whose services are ob- tained under paragraph (1) shall be paid or reimbursed for
p.000831: their expenses associated with traveling to and from their assignment location in accordance with sections
p.000831: 5724, 5724a(a), 5724a(c), and 5726(c) of title 5, United States Code.
p.000831: (B) Expenses specified in subparagraph (A) may not be allowed in connection with the assignment of an expert or
p.000831: consultant whose services are obtained under paragraph (1), unless and until the expert or consultant
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p.000833: 833
p.000833: PUBLIC HEALTH SERVICE ACT
p.000833: Sec. 501
p.000833:
p.000833: appoint and pay members of such groups, except that officers and employees of the United States shall
p.000833: not receive additional com- pensation for services as members of such groups. The Federal Ad- visory Committee Act
p.000833: shall not apply to the duration of a peer re- view group appointed under this subsection.
p.000833: (j) VOLUNTARY SERVICES.—The Assistant Secretary may accept voluntary and uncompensated services.
p.000833: (k) ADMINISTRATION.—The Assistant Secretary shall ensure that programs and activities assigned under
p.000833: this title to the Ad- ministration are fully administered by the respective Centers to which such programs
p.000833: and activities are assigned.
p.000833: (l) STRATEGIC PLAN.—
p.000833: (1) IN GENERAL.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant Secretary shall
p.000833: develop and carry out a strategic plan in accordance with this sub- section for the planning and operation of
p.000833: activities carried out by the Administration, including evidence-based programs.
p.000833: (2) COORDINATION.—In developing and carrying out the strategic plan under this subsection, the Assistant
p.000833: Secretary shall take into consideration the findings and recommenda- tions of the Assistant Secretary for
p.000833: Planning and Evaluation under section 6021(d) of the Helping Families in Mental Health Crisis
p.000833: Reform Act of 2016 and the report of the Inter- departmental Serious Mental Illness Coordinating
p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000833: January 30, 2020
p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000833: January 30, 2020
p.000833:
p.000833: priate, for individuals with a mental or substance use dis- order;
p.000833: (D) identify opportunities to collaborate with the Health Resources and Services Administration to
p.000833: develop or improve—
p.000833: (i) initiatives to encourage individuals to pursue careers (especially in rural and underserved areas and with
p.000833: rural and underserved populations) as psychia- trists, including child and adolescent psychiatrists,
p.000833: psychologists, psychiatric nurse practitioners, physi- cian assistants, clinical social workers, certified
p.000833: peer support specialists, licensed professional counselors, or other licensed or certified mental health or
p.000833: substance use disorder professionals, including such profes- sionals specializing in the diagnosis,
p.000833: evaluation, or treatment of adults with a serious mental illness or children with a serious emotional
p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
p.000833: adults with a se- rious mental illness and children with a serious emotional disturbance, and for individuals with
p.000833: a substance use dis- order.
p.000833: (m) BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.—Not later than September 30, 2020,
p.000833: and every 2 years thereafter, the Assistant Secretary shall prepare and submit to the Committee on Energy and Commerce
p.000833: and the Committee on Appro- priations of the House of Representatives and the Committee on Health, Education,
p.000833: Labor, and Pensions and the Committee on Ap- propriations of the Senate, and post on the Internet website of the
p.000833: Administration, a report containing at a minimum—
p.000833: (1) a review of activities conducted or supported by the Ad- ministration, including progress toward strategic
p.000833: priorities, goals, and objectives identified in the strategic plan developed under subsection (l);
p.000833: (2) an assessment of programs and activities carried out by the Assistant Secretary, including the extent to
p.000833: which pro- grams and activities under this title and part B of title XIX meet identified goals and
p.000833: performance measures developed for the respective programs and activities;
p.000833: (3) a description of the progress made in addressing gaps in mental and substance use disorders
p.000833: prevention, treatment, and recovery services and improving outcomes by the Adminis-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: 835
p.000835: PUBLIC HEALTH SERVICE ACT
p.000835: Sec. 501
p.000835:
p.000835: tration, including with respect to serious mental illnesses, seri- ous emotional disturbances, and co-occurring
p.000835: disorders;
p.000835: (4) a description of the manner in which the Administra- tion coordinates and partners with other Federal
p.000835: agencies and departments related to mental and substance use disorders, in- cluding activities related to—
p.000835: (A) the implementation and dissemination of research findings into improved programs, including with respect to
p.000835: how advances in serious mental illness and serious emo- tional disturbance research have been incorporated
p.000835: into programs;
p.000835: (B) the recruitment, training, and retention of a men- tal and substance use disorders workforce;
p.000835: (C) the integration of mental disorder services, sub- stance use disorder services, and physical health
p.000835: services;
p.000835: (D) homelessness; and
p.000835: (E) veterans;
p.000835: (5) a description of the manner in which the Administra- tion promotes coordination by grantees under
p.000835: this title, and part B of title XIX, with State or local agencies; and
p.000835: (6) a description of the activities carried out under section 501A(e), with respect to mental and substance use
p.000835: disorders, including—
p.000835: (A) the number and a description of grants awarded;
p.000835: (B) the total amount of funding for grants awarded;
p.000835: (C) a description of the activities supported through such grants, including outcomes of programs
p.000835: supported; and
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p.000835: (D) information on how the National Mental Health and Substance Use Policy Laboratory is consulting with
p.000835: the Assistant Secretary for Planning and Evaluation and collaborating with the Center for Substance Abuse
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p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
p.000835: SEC. 501A. ø290aa–0¿ NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
p.000835: (a) IN GENERAL.—There shall be established within the Admin- istration a National Mental Health and Substance Use
p.000835: Policy Lab- oratory (referred to in this section as the ‘‘Laboratory’’).
p.000835: (b) RESPONSIBILITIES.—The Laboratory shall—
p.000835: (1) continue to carry out the authorities and activities that were in effect for the Office of Policy, Planning, and
p.000835: Innovation as such Office existed prior to the date of enactment of the Helping Families in Mental Health
p.000835: Crisis Reform Act of 2016;
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: 837
p.000837: PUBLIC HEALTH SERVICE ACT
p.000837: Sec. 501A
p.000837:
p.000837: (2) identify, coordinate, and facilitate the implementation of policy changes likely to have a significant
p.000837: effect on mental health, mental illness, recovery supports, and the prevention and treatment of substance use
p.000837: disorder services;
p.000837: (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information
p.000837: from grant- ees under programs operated by the Administration in order to evaluate and disseminate information on
p.000837: evidence-based prac- tices, including culturally and linguistically appropriate serv- ices, as appropriate, and
p.000837: service delivery models;
p.000837: (4) provide leadership in identifying and coordinating poli- cies and programs, including evidence-based programs,
p.000837: related to mental and substance use disorders;
p.000837: (5) periodically review programs and activities operated by the Administration relating to the diagnosis or
p.000837: prevention of, treatment for, and recovery from, mental and substance use disorders to—
p.000837: (A) identify any such programs or activities that are duplicative;
p.000837: (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
p.000837: (C) formulate recommendations for coordinating, elimi- nating, or improving programs or activities
p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
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p.000837: January 30, 2020
p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
p.000837:
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p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
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p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
...

p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
p.000841: (1) a summary of the manner in which individuals with co- occurring disorders are receiving treatment, including the
p.000841: most up-to-date information available regarding the number of chil- dren and adults with co-occurring mental illness
p.000841: and substance abuse disorders and the manner in which funds provided under sections 1911 and 1921 are
p.000841: being utilized, including the number of such children and adults served with such funds;
p.000841: (2) a summary of improvements necessary to ensure that individuals with co-occurring mental illness
p.000841: and substance abuse disorders receive the services they need;
p.000841: (3) a summary of practices for preventing substance abuse among individuals who have a mental illness and are
p.000841: at risk of having or acquiring a substance abuse disorder; and
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000841:
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p.000843: 843
p.000843: PUBLIC HEALTH SERVICE ACT
p.000843: Sec. 505
p.000843:
p.000843: (4) a summary of evidenced-based practices for treating in- dividuals with co-occurring mental illness and substance
p.000843: abuse disorders and recommendations for implementing such prac- tices.
p.000843: (c) FUNDS FOR REPORT.—The Secretary may obligate funds to carry out this section with such appropriations as
p.000843: are available.
p.000843: SEC. 504. 1 ø290aa–3¿ PEER REVIEW.
p.000843: (a) IN GENERAL.—The Secretary, after consultation with the Assistant Secretary, shall require
p.000843: appropriate peer review of grants, cooperative agreements, and contracts to be administered through the
p.000843: agency which exceed the simple acquisition threshold as defined in section 4(11) of the Office of Federal
p.000843: Procurement Pol- icy Act.
p.000843: (b) MEMBERS.—The members of any peer review group estab- lished under subsection (a) shall be individuals
p.000843: who by virtue of their training or experience are eminently qualified to perform the review functions of the
p.000843: group. Not more than one-fourth of the members of any such peer review group shall be officers or employ- ees of
p.000843: the United States. In the case of any such peer review group that is reviewing a grant, cooperative agreement,
p.000843: or contract re- lated to mental illness treatment, not less than half of the mem- bers of such peer
p.000843: review group shall be licensed and experienced professionals in the prevention, diagnosis, or treatment of, or
p.000843: recov- ery from, mental illness or co-occurring mental illness and sub- stance use disorders and have a
p.000843: medical degree, a doctoral degree in psychology, or an advanced degree in nursing or social work from an
p.000843: accredited program, and the Secretary, in consultation with the Assistant Secretary, shall, to the extent
p.000843: possible, ensure such peer review groups include broad geographic representation, including both urban and
p.000843: rural representatives.
p.000843: (c) ADVISORY COUNCIL REVIEW.—If the direct cost of a grant or cooperative agreement (described in subsection (a))
p.000843: exceeds the simple acquisition threshold as defined by section 4(11) of the Of- fice of Federal
p.000843: Procurement Policy Act, the Secretary may make such a grant or cooperative agreement only if such grant or
p.000843: cooper- ative agreement is recommended—
p.000843: (1) after peer review required under subsection (a); and
p.000843: (2) by the appropriate advisory council.
p.000843: (d) CONDITIONS.—The Secretary may establish limited excep- tions to the limitations contained in this
p.000843: section regarding partici- pation of Federal employees and advisory council approval. The cir- cumstances under
p.000843: which the Secretary may make such an excep- tion shall be made public.
p.000843: SEC. 505. ø290aa–4¿ CENTER FOR BEHAVIORAL HEALTH STATISTICS AND QUALITY. 2
p.000843: (a) IN GENERAL.—The Assistant Secretary shall maintain with- in the Administration a Center for Behavioral
p.000843: Health Statistics
p.000843:
p.000843: 1 Section 504 appears according to the probable intent of the Congress. Section 3401(b) of Pub- lic Law 106–310 (114
p.000843: Stat. 1218) provides that the section ‘‘is amended as follows:’’. No amend- atory instructions were then given, but a
p.000843: substitute text was provided. The amendment probably should have instructed that section 504 ‘‘is amended to read as
p.000843: follows:’’.
p.000843: 2 Section 502 of Public Law 104–237 (110 Stat. 3112) provides as follows:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: Continued
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
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p.000843: Sec. 505 PUBLIC HEALTH SERVICE ACT 844
p.000843:
p.000843: and Quality (in this section referred to as the ‘‘Center’’). The Cen- ter shall be headed by a Director (in
p.000843: this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive
p.000843: experience and academic qualifications in research and analysis in behavioral health care or related fields. (b)
p.000843: The Director shall—
p.000843: (1) coordinate the Administration’s integrated data strategy, including by collecting data each year on——
p.000843: (A) the national incidence and prevalence of the var- ious forms of mental illness and substance abuse; and
p.000843: (B) the incidence and prevalence of such various forms in major metropolitan areas selected by the Director. 3
p.000843: (2) provide statistical and analytical support for activities of the Administration;
p.000843: (3) recommend a core set of performance metrics to evalu- ate activities supported by the Administration; and
p.000843: (4) coordinate with the Assistant Secretary, the Assistant Secretary for Planning and Evaluation, and the
p.000843: Chief Medical Officer appointed under section 501(g), as appropriate, to im- prove the quality of services
p.000843: provided by programs of the Ad- ministration and the evaluation of activities carried out by the Administration.
p.000843: (c) MENTAL HEALTH.—With respect to the activities of the Di- rector under subsection (b)(1) relating to mental
p.000843: health, the Direc- tor shall ensure that such activities include, at a minimum, the col- lection of data on—
p.000843: (1) the number and variety of public and nonprofit private treatment programs;
p.000843: (2) the number and demographic characteristics of individ- uals receiving treatment through such programs;
p.000843: (3) the type of care received by such individuals; and
p.000843: (4) such other data as may be appropriate.
p.000843: (d) SUBSTANCE ABUSE.—
p.000843: (1) IN GENERAL.—With respect to the activities of the Di- rector under subsection (b)(1) relating to
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p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
p.000845: homeless in- dividuals;
p.000845: (2) entities that demonstrate effectiveness in serving run- away, homeless, and street youth;
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 4 The heading for paragraph (2) is the result of the amendment made by section 6004(6)(C) of Public Law
p.000845: 114–255. Such amendment probably should not have been made to strike ‘‘AN- NUAL SURVEYS’’ (initial cap and
p.000845: small caps) and instead should have been ‘‘Annual Surveys’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000845: Sec. 506A PUBLIC HEALTH SERVICE ACT 846
p.000845:
p.000845: (3) entities that have experience in providing substance use disorder and mental health services to
p.000845: homeless individ- uals;
p.000845: (4) entities that demonstrate experience in providing hous- ing for individuals in treatment for or in recovery from
p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
p.000845: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000845: shall give priority to applicants that—
p.000845: (1) propose to provide alcohol and drug prevention or treat- ment services on reservations;
p.000845: (2) propose to employ culturally-appropriate approaches, as determined by the Secretary, in providing such services;
p.000845: and
p.000845: (3) have provided prevention or treatment services to Na- tive Alaskan entities and Indian tribes and tribal
p.000845: organizations for at least 1 year prior to applying for a grant under this sec- tion.
...

p.000855: tribes and tribal organizations (as the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in
p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000855: January 30, 2020
p.000855:
p.000855: mination and Education Assistance Act) to focus on emerging trends in substance abuse and co-occurrence
p.000855: of substance use disorders with mental illness or other conditions.
p.000855: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000855: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000855: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000855: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000855: public or nonprofit private entities.
p.000855: (b) PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS.—
p.000855: (1) IN GENERAL.—Priority substance use disorder treat- ment needs of regional and national significance shall be
p.000855: deter- mined by the Secretary after consultation with States and other interested groups. The Secretary
p.000855: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000855: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000855: con- sideration to promoting the integration of substance use dis- order treatment services into primary health
p.000855: care systems.
p.000855: (c) REQUIREMENTS.—
p.000855: (1) IN GENERAL.—Recipients of grants, contracts, or cooper- ative agreements under this section shall comply with
...

p.000857:
p.000857: January 30, 2020
p.000857:
p.000857: (c) RESERVATION OF SPACE.—Prior to notifying States of the availability of space at military facilities
p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000859: 859
p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000873: (2) DISSEMINATION OF FINDINGS.—The Secretary shall upon receiving a report under paragraph (1) disseminate the
p.000873: find- ings to appropriate public and private entities.
p.000873: (d) DURATION OF AWARDS.—With respect to an award under subsection (a), the period during which
p.000873: payments under such award are made to the recipient may not exceed 5 years.
p.000873: (e) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a) and shall disseminate
p.000873: the findings with respect to each such evaluation to appropriate public and pri- vate entities.
p.000873: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000873: to be appropriated
p.000873: $5,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003.
p.000873: Subpart 3—Center for Mental Health Services
p.000873: CENTER FOR MENTAL HEALTH SERVICES
p.000873: SEC. 520. ø290bb–31¿ (a) ESTABLISHMENT.—There is estab- lished in the Administration a Center for Mental
p.000873: Health Services (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000873: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000873: individ- uals with extensive experience or academic qualifications in the provision of mental health
p.000873: services or in the evaluation of mental health service systems.
p.000873: (b) DUTIES.—The Director of the Center shall—
p.000873: (1) design national goals and establish national priorities for—
p.000873: (A) the prevention of mental illness; and
p.000873: (B) the promotion of mental health;
p.000873: (2) encourage and assist local entities and State agencies to achieve the goals and priorities described
p.000873: in paragraph (1);
p.000873:
p.000873:
p.000873:
p.000873:
p.000873: January 30, 2020
p.000873: 9 So in law. Probably should read ‘‘; and’’. See section 3110 of Public Law 106–310 (114 Stat. 1185).
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000875: PUBLIC HEALTH SERVICE ACT
p.000875: Sec. 520
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p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
p.000875: (11) conduct services-related assessments, including eval- uations of the organization and financing of care,
p.000875: self-help and consumer-run programs, mental health economics, mental health service systems, rural mental
p.000875: health and tele-mental health, and improve the capacity of State to conduct evalua- tions of publicly
p.000875: funded mental health programs;
p.000875: (12) disseminate mental health information, including evi- dence-based practices, to States, political
p.000875: subdivisions, edu- cational agencies and institutions, treatment and prevention service providers, and the
p.000875: general public, including information concerning the practical application of research supported by the
p.000875: National Institute of Mental Health that is applicable to improving the delivery of services;
p.000875: (13) provide technical assistance to public and private enti- ties that are providers of mental health services;
p.000875: (14) monitor and enforce obligations incurred by commu- nity mental health centers pursuant to the Community
p.000875: Mental Health Centers Act (as in effect prior to the repeal of such Act on August 13, 1981, by section
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p.000889: subsection (b)(2) con- tains information on any qualified practitioner that is certified to prescribe
p.000889: medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act, the
p.000889: Assistant Sec- retary—
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p.000889: January 30, 2020
p.000889: (1) shall provide an opportunity to such practitioner to have the contact information of the practitioner
p.000889: removed from the website at the request of the practitioner; and
p.000889: (2) may evaluate other methods to periodically update the information displayed on such website.
p.000889: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prevent the Assistant Secretary from
p.000889: using any unob- ligated amounts otherwise made available to the Administration to maintain the Routing Service.
p.000889: SEC. 520F. ø290bb–37¿ STRENGTHENING COMMUNITY CRISIS RE- SPONSE SYSTEMS.
p.000889: (a) IN GENERAL.—The Secretary shall award competitive grants to—
p.000889: (1) State and local governments and Indian tribes and trib- al organizations, to enhance community-based crisis
p.000889: response systems; or
p.000889: (2) States to develop, maintain, or enhance a database of beds at inpatient psychiatric facilities, crisis
p.000889: stabilization units, and residential community mental health and residential sub- stance use disorder treatment
p.000889: facilities, for adults with a seri- ous mental illness, children with a serious emotional disturb- ance, or
p.000889: individuals with a substance use disorder.
p.000889: (b) APPLICATIONS.—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000889: Sec. 520F PUBLIC HEALTH SERVICE ACT 890
p.000889: (1) IN GENERAL.—To receive a grant under subsection (a), an entity shall submit to the Secretary an
p.000889: application, at such time, in such manner, and containing such information as the Secretary may require.
p.000889: (2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An applica- tion for a grant under subsection (a)(1) shall include
p.000889: a plan for—
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p.000889: (A) promoting integration and coordination between local public and private entities engaged in crisis response,
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p.000891: (2) individuals reporting improved functional outcomes;
p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000891:
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
p.000891: (2) create or expand community-based mental health and co-occurring mental illness and substance use disorder
p.000891: services to accommodate the diversion program;
p.000891: (3) train professionals involved in the system of care, and law enforcement officers, attorneys, and judges;
p.000891: (4) provide community outreach and crisis intervention;
p.000891: and
p.000891: (5) develop programs to divert individuals prior to booking
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p.000891: January 30, 2020
p.000891: or arrest.
p.000891: (f) FEDERAL SHARE.—
p.000891: (1) IN GENERAL.—The Secretary shall pay to a State, polit- ical subdivision of a State, Indian tribe, or tribal
p.000891: organization receiving a grant under subsection (a) the Federal share of the cost of activities described in the
p.000891: application.
p.000891: (2) FEDERAL SHARE.—The Federal share of a grant made under this section shall not exceed 75 percent of the
p.000891: total cost of the program carried out by the State, political subdivision of a State, Indian tribe, or tribal
p.000891: organization. Such share shall be used for new expenses of the program carried out by such State, political
p.000891: subdivision of a State, Indian tribe, or tribal or- ganization.
p.000891: (3) NON-FEDERAL SHARE.—The non-Federal share of pay- ments made under this section may be made in cash or in kind
p.000891: fairly evaluated, including planned equipment or services. The Secretary may waive the requirement of matching
p.000891: contribu- tions.
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p.000891:
p.000891:
p.000893: 893
p.000893: PUBLIC HEALTH SERVICE ACT
p.000893: Sec. 520I
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p.000893: January 30, 2020
p.000893: tributed among the geographical regions of the United States and between urban and rural populations.
p.000893: (h) TRAINING AND TECHNICAL ASSISTANCE.—Training and tech- nical assistance may be provided by the Secretary to
p.000893: assist a State, political subdivision of a State, Indian tribe, or tribal organization receiving a grant under
p.000893: subsection (a) in establishing and operating a diversion program.
p.000893: (i) EVALUATIONS.—The programs described in subsection (a) shall be evaluated not less than one time in every
p.000893: 12-month period using the methodology and outcome measures identified in the grant application.
p.000893: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000893: $4,269,000 for each of fiscal years 2018 through 2022.
p.000893: øSection 520H was repealed by section 9017 of Public Law 114–255.¿
p.000893: SEC. 520I. ø290bb–40¿ GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS MENTAL ILLNESS AND CO-OCCURRING
p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: Sec. 520J PUBLIC HEALTH SERVICE ACT 894
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p.000893: previously provided only mental health services or only sub- stance abuse services; and
p.000893: (6) to provide services in coordination with other existing public and private community programs.
p.000893: (d) CONDITION.—The Secretary shall ensure that a State, polit- ical subdivision of a State, Indian tribe, tribal
p.000893: organization, or pri- vate nonprofit organization that receives a grant, contract, or coop- erative agreement under
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p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
p.000893: (i) AUTHORIZATION OF APPROPRIATION.—There is authorized to be appropriated to carry out this subsection
p.000893: $40,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 through 2003.
p.000893: SEC. 520J. ø290bb–41¿ MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.000893: (a) IN GENERAL.—The Secretary shall award grants in accord- ance with the provisions of this section.
p.000893: (b) MENTAL HEALTH AWARENESS TRAINING GRANTS.—
p.000893: (1) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian tribes,
p.000893: tribal or- ganizations, and nonprofit private entities to train teachers and other relevant school personnel
p.000893: to recognize symptoms of childhood and adolescent mental disorders, to refer family members to the
p.000893: appropriate mental health services if nec- essary, to train emergency services personnel veterans, law en-
p.000893: forcement, and other categories of individuals, as determined by the Secretary, to identify and appropriately
p.000893: respond to per- sons with a mental illness, and to provide education to such
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: 895
p.000895: PUBLIC HEALTH SERVICE ACT
p.000895: Sec. 520K
p.000895:
p.000895: teachers and personnel regarding resources that are available in the community for individuals with a mental
p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
p.000895: (4) APPLICATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that desires a grant under this subsection shall submit an ap- plication to the Secretary at such
p.000895: time, in such manner, and containing such information as the Secretary may require, in- cluding a plan for
p.000895: the rigorous evaluation of activities that are carried out with funds received under a grant under this sub-
p.000895: section.
p.000895: (5) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private en- tity receiving a grant under this subsection shall use funds from such grant for
p.000895: evidence-based programs that provide training and education in accordance with paragraph (1) on matters
p.000895: including—
p.000895: (A) recognizing the signs and symptoms of mental ill- ness; and
p.000895: (B)(i) resources available in the community for individ- uals with a mental illness and other relevant resources; or
p.000895: (ii) safely de-escalating crisis situations involving indi- viduals with a mental illness.
p.000895: (6) EVALUATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that receives a grant under this subsection shall prepare and submit an evaluation to the
p.000895: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require,
p.000895: including an evaluation of activities carried out with funds received under the grant under this subsection and a
p.000895: process and outcome evaluation.
p.000895: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this
p.000895: subsection$14,693,000 for each of fiscal years 2018 through 2022.
p.000895: SEC. 520K. ø290bb–42¿ INTEGRATION INCENTIVE GRANTS AND COOP- ERATIVE AGREEMENTS.
p.000895: (a) DEFINITIONS.—In this section:
p.000895: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, or other appropriate State agency, in
p.000895: collaboration with 1 or more qualified community programs as described in sec- tion 1913(b)(1) or 1 or
p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
p.000895: and physical
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p.000895: January 30, 2020
p.000895: 13 So in law. Words in the heading (except the first) probably should be all small caps. See section
p.000895: 3213 of Public Law 106–310 (114 Stat. 1206).
p.000895: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: Sec. 520K PUBLIC HEALTH SERVICE ACT 896
p.000895:
p.000895: health services, which may include practices that share the same space in the same facility.
p.000895: (3) SPECIAL POPULATION.—The term ‘‘special population’’ means—
p.000895: (A) adults with a mental illness who have co-occurring physical health conditions or chronic diseases;
p.000895: (B) adults with a serious mental illness who have co- occurring physical health conditions or chronic
p.000895: diseases;
p.000895: (C) children and adolescents with a serious emotional disturbance with co-occurring physical health conditions
p.000895: or chronic diseases; or
p.000895: (D) individuals with a substance use disorder.
p.000895: (b) GRANTS AND COOPERATIVE AGREEMENTS.—
p.000895: (1) IN GENERAL.—The Secretary may award grants and co- operative agreements to eligible entities to support the
p.000895: im- provement of integrated care for primary care and behavioral health care in accordance with paragraph (2).
p.000895: (2) PURPOSES.—A grant or cooperative agreement awarded under this section shall be designed to—
p.000895: (A) promote full integration and collaboration in clin- ical practices between primary and behavioral health
p.000895: care;
p.000895: (B) support the improvement of integrated care models for primary care and behavioral health care to improve the
p.000895: overall wellness and physical health status of adults with a serious mental illness or children with a
p.000895: serious emo- tional disturbance; and
p.000895: (C) promote integrated care services related to screen- ing, diagnosis, prevention, and treatment of mental and
p.000895: substance use disorders, and co-occurring physical health conditions and chronic diseases.
p.000895: (c) APPLICATIONS.—
p.000895: (1) IN GENERAL.—An eligible entity seeking a grant or co- operative agreement under this section shall
p.000895: submit an appli- cation to the Secretary at such time, in such manner, and ac- companied by such
p.000895: information as the Secretary may require, including the contents described in paragraph (2).
p.000895: (2) CONTENTS.—The contents described in this paragraph are—
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p.000895: (A) a description of a plan to achieve fully collabo- rative agreements to provide services to
p.000895: special popu- lations;
p.000895: (B) a document that summarizes the policies, if any, that serve as barriers to the provision of
p.000895: integrated care, and the specific steps, if applicable, that will be taken to address such barriers;
p.000895: (C) a description of partnerships or other arrange- ments with local health care providers to provide
p.000895: services to special populations;
p.000895: (D) an agreement and plan to report to the Secretary performance measures necessary to evaluate patient
p.000895: out- comes and facilitate evaluations across participating projects; and
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p.000897: of funds awarded under this section to administrative functions, and the remaining amounts shall be
p.000897: allocated to health facilities that provide integrated care.
p.000897: (e) DURATION.—A grant or cooperative agreement under this section shall be for a period not to exceed 5 years.
p.000897: (f) REPORT ON PROGRAM OUTCOMES.—An eligible entity receiv- ing a grant or cooperative agreement under this section
p.000897: shall sub- mit an annual report to the Secretary that includes—
p.000897: (1) the progress made to reduce barriers to integrated care as described in the entity’s application under
p.000897: subsection (c); and
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p.000897: January 30, 2020
p.000897: (2) a description of functional outcomes of special popu- lations, including—
p.000897: (A) with respect to adults with a serious mental ill- ness, participation in supportive housing or
p.000897: independent living programs, attendance in social and rehabilitative programs, participation in job training
p.000897: opportunities, satis- factory performance in work settings, attendance at sched- uled medical and mental health
p.000897: appointments, and compli- ance with prescribed medication regimes;
p.000897: (B) with respect to individuals with co-occurring men- tal illness and physical health conditions and chronic
p.000897: dis- eases, attendance at scheduled medical and mental health appointments, compliance with prescribed medication
p.000897: re- gimes, and participation in learning opportunities related to improved health and lifestyle practices; and
p.000897: (C) with respect to children and adolescents with a se- rious emotional disturbance who have co-occurring phys-
p.000897: ical health conditions and chronic diseases, attendance at scheduled medical and mental health
p.000897: appointments, com- pliance with prescribed medication regimes, and participa- tion in learning opportunities at school
p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
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p.000897: Sec. 520L PUBLIC HEALTH SERVICE ACT 898
p.000897:
p.000897: els;
p.000897: (A) development and selection of integrated care mod-
p.000897: (B) dissemination of evidence-based interventions in
p.000897: integrated care;
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p.000899: (B) Implementing evidence-based practices to provide treatment for individuals at risk for suicide,
p.000899: including ap- propriate followup services.
p.000899: (C) Raising awareness and reducing stigma of suicide.
p.000899: (b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant Secretary shall—
p.000899: (1) evaluate the activities supported by grants awarded under subsection (a), and disseminate, as appropriate,
p.000899: the find- ings from the evaluation; and
p.000899: (2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities
p.000899: that receive a grant under this section, in order to help such entities to meet the requirements of this section,
p.000899: including assistance with se- lection and implementation of evidence-based interventions and frameworks
p.000899: to prevent suicide.
p.000899: (c) DURATION.—A grant under this section shall be for a period of not more than 5 years.
p.000899: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $30,000,000
p.000899: for the pe- riod of fiscal years 2018 through 2022.
p.000899: SEC. 520M. ø290bb–44¿ ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
...

p.000899: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.000899: (1) IN GENERAL.—To carry out this section, there is author- ized to be appropriated $5,000,000 for the period of fiscal
p.000899: years 2018 through 2022.
p.000899: (2) USE OF CERTAIN FUNDS.—Of the funds appropriated to carry out this section in any fiscal year, not
p.000899: more than 5 per- cent shall be available to the Assistant Secretary for carrying out subsection (d).
p.000899: PART C—PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS
p.000899: SEC. 521. ø290cc–21¿ FORMULA GRANTS TO STATES.
p.000899: For the purpose of carrying out section 522, the Secretary, act- ing through the Director of the Center for Mental
p.000899: Health Services, shall for each of the fiscal years 2018 through 2022 make an allot- ment for each State in an
p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
p.000899: (B) providing assistance in obtaining and coordinating social and maintenance services for the eligible homeless
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
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p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that not more than 4 percent of the payments will be expended for ad- ministrative
p.000901: expenses regarding the payments.
p.000901: (g) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that—
p.000901: (1) not more than 20 percent of the payments will be ex- pended for housing services under subsection
p.000901: (b)(10); and
p.000901: (2) the payments will not be expended—
p.000901: (A) to support emergency shelters or construction of housing facilities;
p.000901: (B) for inpatient psychiatric treatment costs or inpa- tient substance use disorder treatment costs; or
p.000901: (C) to make cash payments to intended recipients of mental health or substance use disorder services.
p.000901: (h) WAIVER FOR TERRITORIES.—With respect to the United States Virgin Islands, Guam, American Samoa, Palau,
p.000901: the Mar- shall Islands, and the Commonwealth of the Northern Mariana Is- lands, the Secretary may waive the
p.000901: provisions of this part that the Secretary determines to be appropriate.
...

p.000921: (a) PURPOSE.—It is the purpose of this section to increase ac- cess to, and reduce the stigma associated
p.000921: with, mental health serv- ices to ensure that students at institutions of higher education have the support
p.000921: necessary to successfully complete their studies.
p.000921: (b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary, acting through the Assistant Secretary and in
p.000921: collaboration with the Director of the Centers for Disease Control and Prevention, shall convene an
p.000921: interagency, public-private sector working group to plan, establish, and begin coordinating and evaluating
p.000921: a tar- geted public education campaign that is designed to focus on men- tal and behavioral health on the campuses of
p.000921: institutions of higher education. Such campaign shall be designed to—
p.000921: (1) improve the general understanding of mental health and mental disorders;
p.000921: (2) encourage help-seeking behaviors relating to the pro- motion of mental health, prevention of mental
p.000921: disorders, and treatment of such disorders;
p.000921: (3) make the connection between mental and behavioral health and academic success; and
p.000921: (4) assist the general public in identifying the early warn- ing signs and reducing the stigma of mental illness.
p.000921: (c) COMPOSITION.—The working group convened under sub- section (b) shall include—
p.000921: (1) mental health consumers, including students and fam- ily members;
p.000921: (2) representatives of institutions of higher education;
p.000921: (3) representatives of national mental and behavioral health associations and associations of
p.000921: institutions of higher education;
p.000921: (4) representatives of health promotion and prevention or- ganizations at institutions of higher education;
p.000921: (5) representatives of mental health providers, including community mental health centers; and
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000923: PUBLIC HEALTH SERVICE ACT
p.000923: Sec. 550
p.000923:
p.000923: (6) representatives of private-sector and public-sector groups with experience in the development of
p.000923: effective public health education campaigns.
p.000923: (d) PLAN.—The working group under subsection (b) shall de- velop a plan that—
p.000923: (1) targets promotional and educational efforts to the age population of students at institutions of
...

p.000941: ment that is not a standard treatment for the resident’s medical or psychiatric condition.
p.000941: (2) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000941: term does not include a time out.
p.000941: (3) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000941: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000941: (4) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000941: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000941: for the purpose of calming. Time out is not seclusion.
p.000941: SEC. 592. ø290ii–1¿ REPORTING REQUIREMENT.
p.000941: (a) IN GENERAL.—Each facility to which the Protection and Ad- vocacy for Mentally Ill Individuals Act of 1986 20
p.000941: applies shall no- tify the appropriate agency, as determined by the Secretary, of each death that occurs
p.000941: at each such facility while a patient is re- strained or in seclusion, of each death occurring within
p.000941: 24 hours after the patient has been removed from restraints and seclusion,
p.000941:
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p.000941: January 30, 2020
p.000941: 20 Probably should be Protection and Advocacy for Individuals with Mental Illness Act. See section 3206(a)
p.000941: of Public Law 106–310 (114 Stat. 1193).
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000941:
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p.000943: 943
p.000943: PUBLIC HEALTH SERVICE ACT
p.000943: Sec. 595
p.000943:
p.000943: or where it is reasonable to assume that a patient’s death is a re- sult of such seclusion or restraint. A notification
p.000943: under this section shall include the name of the resident and shall be provided not later than 7 days
p.000943: after the date of the death of the individual in- volved.
p.000943: (b) FACILITY.—In this section, the term ‘‘facility’’ has the mean- ing given the term ‘‘facilities’’ in section
p.000943: 102(3) of the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10802(3)).
p.000943: SEC. 593. 21 ø290ii–3¿ REGULATIONS AND ENFORCEMENT.
p.000943: (a) TRAINING.—Not later than 1 year after the date of the en- actment of this part, the Secretary,
p.000943: after consultation with appro- priate State and local protection and advocacy organizations, physi- cians,
p.000943: facilities, and other health care professionals and patients, shall promulgate regulations that require
...

p.000955: agency as the sole agency for supervising the administration of the plan;
p.000955: (2) contain satisfactory evidence that the State agency des- ignated in accordance with paragraph (1) will have
p.000955: authority to carry out such plan in conformity with this part;
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p.000957: PUBLIC HEALTH SERVICE ACT
p.000957: Sec. 604
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p.000957: January 30, 2020
p.000957: (3) provide for the designation of a State advisory council which shall include (A) representatives of
p.000957: nongovernmental or- ganizations or groups, and of public agencies, concerned with the operation,
p.000957: construction, or utilization of hospital or other facilities for diagnosis, prevention, or treatment of
p.000957: illness or disease, or for provision of rehabilitation services, and rep- resentatives particularly
p.000957: concerned with education or training of health professions personnel, and (B) an equal number of
p.000957: representatives of consumers familiar with the need for the services provided by such facilities, to
p.000957: consult with the State agency in carrying out the plan, and provide, if such council does not include any
p.000957: representatives of nongovernmental orga- nizations or groups, or State agencies, concerned with rehabili- tation, for
p.000957: consultation with organizations, groups, and State agencies so concerned;
p.000957: (4) set forth, in accordance with criteria established in reg- ulations prescribed under section 603 and on the
p.000957: basis of a statewide inventory of existing facilities, a survey of need, and (except to the extent provided by
p.000957: or pursuant to such regula- tions) community, area, or regional plans—
p.000957: (A) the number of general hospital beds and long-term care beds, and the number and types of hospital
p.000957: facilities and facilities for long-term care, needed to provide ade- quate facilities for inpatient care
p.000957: of people residing in the State, and a plan for the distribution of such beds and fa- cilities in service areas
p.000957: throughout the State;
p.000957: (B) the public health centers needed to provide ade- quate public health services for people residing in
p.000957: the State, and a plan for the distribution of such centers throughout the State;
p.000957: (C) the outpatient facilities needed to provide ade- quate diagnostic or treatment services to ambulatory
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p.001121: January 30, 2020
p.001121:
p.001121: (5) OPERATION.—Operation. In carrying out the duties under paragraph (2), the Task Force is not subject to
p.001121: the provi- sions of Appendix 2 of title 5, United States Code.
p.001121: (6) INDEPENDENCE.—All members of the Task Force con- vened under this subsection, and any recommendations
p.001121: made by such members, shall be independent and, to the extent prac- ticable, not subject to political pressure.
p.001121: (7) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated such sums as may be necessary
p.001121: for each fiscal year to carry out the activities of the Task Force.
p.001121: (b) PRIMARY CARE RESEARCH.—
p.001121: (1) IN GENERAL.—There is established within the Agency a Center for Primary Care Research (referred to in this
p.001121: sub- section as the ‘‘Center’’) that shall serve as the principal source of funding for primary care practice
p.001121: research in the Depart- ment of Health and Human Services. For purposes of this paragraph, primary care
p.001121: research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral
p.001121: to specialty care, preventive care, and the relation- ship between the clinician and the patient in the context
p.001121: of the family and community.
p.001121: (2) RESEARCH.—In carrying out this section, the Center shall conduct and support research concerning—
p.001121: (A) the nature and characteristics of primary care practice;
p.001121: (B) the management of commonly occurring clinical problems;
p.001121: (C) the management of undifferentiated clinical prob- lems; and
p.001121: (D) the continuity and coordination of health services.
p.001121: SEC. 916. ø299b–5¿ HEALTH CARE PRACTICE AND TECHNOLOGY INNO- VATION.
p.001121: (a) IN GENERAL.—The Director shall promote innovation in evi- dence-based health care practices and technologies by—
p.001121: (1) conducting and supporting research on the develop- ment, diffusion, and use of health care technology;
p.001121: (2) developing, evaluating, and disseminating methodolo- gies for assessments of health care practices and
p.001121: technologies;
p.001121: (3) conducting intramural and supporting extramural as- sessments of existing and new health care
p.001121: practices and tech- nologies;
p.001121: (4) promoting education and training and providing tech- nical assistance in the use of health care
p.001121: practice and tech- nology assessment methodologies and results; and
p.001121: (5) working with the National Library of Medicine and the public and private sector to develop an electronic
p.001121: clearinghouse of currently available assessments and those in progress.
p.001121: (b) SPECIFICATION OF PROCESS.—
...

p.001215: payments shall be fixed in accordance with the regulations of the Secretary. If a health maintenance organization
p.001215: offers to its members the opportunity to obtain basic health services through a physician not described in sub-
p.001215: section (b)(3)(A), the organization may require, in addition to payments described in clause (D) of this
p.001215: paragraph, a reason- able deductible to be paid by a member when obtaining a basic health service from such a
p.001215: physician. A health maintenance or- ganization may include a health service, defined as a supple- mental
p.001215: health service by section 1302(2), in the basic health services provided its members for a basic health
p.001215: services pay- ment described in the first sentence. In the case of an entity which before it became a
p.001215: qualified health maintenance organi- zation (within the meaning of section 1310(d)) provided com- prehensive
p.001215: health services on a prepaid basis, the requirement of clause (C) shall not apply to such entity until the expiration
p.001215: of the forty-eight month period beginning with the month fol- lowing the month in which the entity became such
p.001215: a qualified health organization. The requirements of this paragraph re- specting the basic health services
p.001215: payment shall not apply to the provision of basic health services to a member for an ill- ness or
p.001215: injury for which the member is entitled to benefits under a workmen’s compensation law or an insurance
p.001215: policy but only to the extent such benefits apply to such services. For the provision of such services for an illness
p.001215: or injury for which a member is entitled to benefits under such a law, the health maintenance organization
p.001215: may, if authorized by such law, charge or authorize the provider of such services to charge, in accordance
p.001215: with the charges allowed under such law, the insur- ance carrier, employer, or other entity which under such
p.001215: law is to pay for the provision of such services or, to the extent that such member has been paid under such law
p.001215: for such services, such member. For the provision of such services for an illness or injury for which
p.001215: a member is entitled to benefits under an insurance policy, a health maintenance organization may
p.001215: charge or authorize the provider of such services to charge the insurance carrier under such policy or, to the extent
p.001215: that such member has been paid under such policy for such services, such member.
p.001215: (2) For such payment or payments (hereinafter in this title
p.001215: referred to as ‘‘supplemental health services payments’’) as the health maintenance organization may require in
p.001215: addition to the basic health services payment, the organization may pro- vide to each of its members any
p.001215: of the health services which
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p.001215: Sec. 1301 PUBLIC HEALTH SERVICE ACT 1216
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p.001217: PUBLIC HEALTH SERVICE ACT
p.001217: Sec. 1301
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p.001217: promptness and in a manner which assures continuity, and when medically necessary be available and
p.001217: accessible twenty- four hours a day and seven days a week, except that a health maintenance organization which has
p.001217: a service area located wholly in a nonmetropolitan area may make a basic health service available outside
p.001217: its service area if that basic health service is not a primary care or emergency health care service and if
p.001217: there is an insufficient number of providers of that basic health service within the service area who will
p.001217: provide such service to members of the health maintenance organization. A member of a health maintenance
p.001217: organization shall be reim- bursed by the organization for his expenses in securing basic and supplemental
p.001217: health services other than through the orga- nization if the services were medically necessary and imme-
p.001217: diately required because of an unforeseen illness, injury, or condition.
p.001217: (5) To the extent that a natural disaster, war, riot, civil in- surrection, or any other similar event not within the
p.001217: control of a health maintenance organization (as determined under regu- lations of the Secretary) results in the
p.001217: facilities, personnel, or financial resources of a health maintenance organization not being available to
p.001217: provide or arrange for the provision of a basic or supplemental health service in accordance with the re-
p.001217: quirements of paragraphs (1) through (4) of this subsection, such requirements only require the
p.001217: organization to make a good-faith effort to provide or arrange for the provision of such service within such
p.001217: limitation on its facilities, personnel, or re- sources.
p.001217: (6) A health maintenance organization that otherwise meets the requirements of this title may offer a
p.001217: high-deductible health plan (as defined in section 220(c)(2) of the Internal Rev- enue Code of 1986).
p.001217: (c) Each health maintenance organization shall— (1)(A) have—
p.001217: (i) a fiscally sound operation, and
p.001217: (ii) adequate provision against the risk of insolvency, which is satisfactory to the Secretary, and (B) have
p.001217: administra- tive and managerial arrangements satisfactory to the Sec- retary;
p.001217: (2) assume full financial risk on a prospective basis for the provision of basic health services, except that a health
p.001217: mainte- nance organization may (A) obtain insurance or make other ar- rangements for the cost of providing to
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p.001269: January 30, 2020
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p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
p.001269: appropriate settings representative of broad cross sections of the population, and include public edu- cation
p.001269: activities of voluntary health agencies, professional med- ical societies, and other private nonprofit health
p.001269: organizations,
p.001269: (B) focus on objectives that are measurable, and (C) emphasize
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001269: Sec. 1704 PUBLIC HEALTH SERVICE ACT 1270
p.001269:
p.001269: the prevention or moderation of illness or accidents that ap- pear controllable through individual
p.001269: knowledge and behavior;
p.001269: (2) provide consultation and technical assistance to organi- zations that request help in planning, operating, or
p.001269: evaluating programs in such matters;
p.001269: (3) develop health information and health promotion mate- rials and teaching programs including (A) model
p.001269: curriculums for the training of educational and health professionals and paraprofessionals in health
p.001269: education by medical, dental, and nursing schools, schools of public health, and other institutions engaged in
p.001269: training of educational or health professionals, (B) model curriculums to be used in elementary and
p.001269: secondary schools and institutions of higher learning, (C) materials and programs for the continuing
p.001269: education of health professionals and paraprofessionals in the health education of their patients,
p.001269: (D) materials for public service use by the printed and broad- cast media, and (E) materials and programs to
p.001269: assist providers of health care in providing health education to their patients; and
p.001269: (4) support demonstration and evaluation programs for in-
p.001269: dividual and group self-help programs designed to assist the participant in using his individual
p.001269: capacities to deal with health problems, including programs concerned with obesity, hypertension, and
p.001269: diabetes.
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p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001295: Sec. 1911 PUBLIC HEALTH SERVICE ACT 1296
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p.001295: for fiscal year 2013, $30,387,656 for fiscal year 2014, $20,213,000 for each of fiscal years 2015
p.001295: through 2019, and $22,334,000 for each of fiscal years 2020 through 2024.
p.001295: PART B—BLOCK GRANTS REGARDING MENTAL HEALTH AND
p.001295: SUBSTANCE ABUSE
p.001295:
p.001295: Subpart I—Block Grants for Community Mental Health Services
p.001295: SEC. 1911. ø300x¿ FORMULA GRANTS TO STATES.
p.001295: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Director of the
p.001295: Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined
p.001295: in accordance with section 1918. The Secretary shall make a grant to the State of the allotment made
p.001295: for the State for the fiscal year if the State submits to the Secretary an application in accordance with
p.001295: section 1917.
p.001295: (b) PURPOSE OF GRANTS.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001295: 1916, the State in- volved will expend the grant only for the purpose of—
p.001295: (1) providing community mental health services for adults with a serious mental illness and children with a serious
p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
p.001295: health services to adults with a serious mental illness and to children with a se- rious emotional disturbance;
p.001295: (2) the plan meets the criteria specified in subsection (b);
p.001295: and
p.001295: (3) the plan is approved by the Secretary.
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p.001295: (b) CRITERIA FOR PLAN.—In accordance with subsection (a), a State shall submit to the Secretary a plan every
p.001295: two years that, at a minimum, includes each of the following:
p.001295: (1) SYSTEM OF CARE.—A description of the State’s system of care that contains the following:
p.001295: (A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYS- TEMS.—The plan shall—
p.001295: (i) identify the single State agency to be respon- sible for the administration of the program under
p.001295: the grant, including any third party who administers men- tal health services and is responsible for complying
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
p.001297: (I) a description of the activities intended to reduce hospitalizations and hospital stays using the block
p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: Sec. 1912 PUBLIC HEALTH SERVICE ACT 1298
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p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
p.001299: (2) STANDARDIZED METHODS.—The Secretary shall estab- lish standardized methods for making the estimates
p.001299: required in subsection (b)(11) with respect to a State. A funding agree- ment for a grant under section
p.001299: 1911 for the State is that the State will utilize such methods in making the estimates.
p.001299: (3) DATE CERTAIN FOR COMPLIANCE BY SECRETARY.—Not later than 90 days after the date of the
p.001299: enactment of the ADAMHA Reorganization Act 1, the Secretary shall establish the definitions described in
p.001299: paragraph (1), shall begin dissemi- nation of the definitions to the States, and shall establish the
p.001299: standardized methods described in paragraph (2).
p.001299: (d) REQUIREMENT OF IMPLEMENTATION OF PLAN.—
p.001299: (1) COMPLETE IMPLEMENTATION.—Except as provided in paragraph (2), in making a grant under section 1911 to a State
p.001299: for a fiscal year, the Secretary shall make a determination of the extent to which the State has
p.001299: implemented the plan re- quired in subsection (a). If the Secretary determines that a State has not
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p.001299: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001299: 120 days after the date on which the request is made.
p.001299: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001299: in- volved.
p.001299: (b) PROVIDERS OF SERVICES.—A funding agreement for a grant under section 1911 for a State is that, with respect to the
p.001299: plan sub- mitted under section 1912(a) for the fiscal year involved—
p.001299: (1) services under the plan will be provided only through appropriate, qualified community programs (which may
p.001299: include community mental health centers, child mental-health pro- grams, psychosocial rehabilitation
p.001299: programs, mental health peer-support programs, and mental-health primary consumer- directed programs); and
p.001299: (2) services under the plan will be provided through com- munity mental health centers only if the centers
p.001299: meet the cri- teria specified in subsection (c).
p.001299: (c) CRITERIA FOR MENTAL HEALTH CENTERS.—The criteria re- ferred to in subsection (b)(2) regarding
p.001299: community mental health centers are as follows:
p.001299: (1) With respect to mental health services, the centers pro- vide services as follows:
p.001299: (A) Services principally to individuals residing in a de- fined geographic area (hereafter in this subsection referred
p.001299: to as a ‘‘service area’’).
p.001299: (B) Outpatient services, including specialized out- patient services for children, the elderly,
p.001299: individuals with a serious mental illness, and residents of the service areas of the centers who have been
p.001299: discharged from inpatient treatment at a mental health facility.
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p.001299: 2 So in law. See section 201 of Public Law 102–321 (106 Stat. 381). Probably should be ‘‘dis-
p.001299: turbance’’.
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p.001301: PUBLIC HEALTH SERVICE ACT
p.001301: Sec. 1914
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p.001301: (C) 24-hour-a-day emergency care services.
p.001301: (D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services.
p.001301: (E) Screening for patients being considered for admis- sion to State mental health facilities to determine the
p.001301: ap- propriateness of such admission.
p.001301: (2) The mental health services of the centers are provided, within the limits of the capacities of the centers,
p.001301: to any indi- vidual residing or employed in the service area of the center regardless of ability to pay
p.001301: for such services.
p.001301: (3) The mental health services of the centers are available and accessible promptly, as appropriate and in a manner
p.001301: which preserves human dignity and assures continuity and high qual- ity care.
p.001301: SEC. 1914. ø300x–3¿ STATE MENTAL HEALTH PLANNING COUNCIL.
p.001301: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will
p.001301: establish and maintain a State mental health planning council in accordance with the condi- tions described in this
p.001301: section.
p.001301: (b) DUTIES.—A condition under subsection (a) for a Council is that the duties of the Council are—
p.001301: (1) to review plans provided to the Council pursuant to section 1915(a) by the State involved and to
p.001301: submit to the State any recommendations of the Council for modifications to the plans;
p.001301: (2) to serve as an advocate for adults with a serious men- tal illness, children with a severe emotional
p.001301: disturbance, and other individuals with mental illnesses or emotional problems; and
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
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p.001301:
p.001301: January 30, 2020
p.001301: (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of
p.001301: mental health serv- ices within the State.
p.001301: (c) MEMBERSHIP.—
p.001301: (1) IN GENERAL.—A condition under subsection (a) for a Council is that the Council be composed of
p.001301: residents of the State, including representatives of—
p.001301: (A) the principal State agencies with respect to—
p.001301: (i) mental health, education, vocational rehabilita- tion, criminal justice, housing, and social services; and
p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
...

p.001307: (2) MINIMUM ALLOTMENT FOR TERRITORIES.—The amount of an allotment under section 1911 for a territory of the
p.001307: United States for a fiscal year shall be the greater of—
p.001307: (A) the amount determined under paragraph (1) for the territory for the fiscal year;
p.001307: (B) $50,000; and
p.001307: (C) with respect to fiscal years 1993 and 1994, an amount equal to 20.6 percent of the amount received
p.001307: by the territory from allotments made pursuant to this part for fiscal year 1992.
p.001307: (3) RESERVATION OF AMOUNTS.—The Secretary shall each fiscal year reserve for the territories of the
p.001307: United States 1.5 percent of the amounts appropriated under section 1920(a) for allotments under section 1911 for the
p.001307: fiscal year.
p.001307: (4) AVAILABILITY OF DATA ON POPULATION.—With respect to data on the civilian population of the
p.001307: territories of the United States, if the Secretary determines for a fiscal year that recent such data for
p.001307: purposes of paragraph (1)(B) do not exist regarding a territory, the Secretary shall for such purposes es- timate
p.001307: the civilian population of the territory by modifying the data on the territory to reflect the average extent of change
p.001307: oc- curring during the ensuing period in the population of all terri- tories with respect to which recent such data do
p.001307: exist.
p.001307: (5) APPLICABILITY OF CERTAIN PROVISIONS.—For purposes of subsection (a), the term ‘‘State’’ does not
p.001307: include the terri- tories of the United States.
p.001307: SEC. 1919. ø300x–8¿ DEFINITIONS.
p.001307: For purposes of this subpart:
p.001307: (1) The terms ‘‘adults with a serious mental illness’’ and ‘‘children with a serious emotional
p.001307: disturbance’’ have the meanings given such terms under section 1912(c)(1).
p.001307: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1911 to a State, means that the
p.001307: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001307: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001307:
p.001307:
p.001307:
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p.001307:
p.001307: Sec. 1920 PUBLIC HEALTH SERVICE ACT 1308
p.001307:
p.001307: SEC. 1920. ø300x–9¿ FUNDING.
p.001307: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, and subpart III and
p.001307: section 505(c) with respect to mental health, there are authorized to be appropriated
p.001307: $532,571,000 for each of fiscal years 2018 through 2022.
p.001307: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, DATA COLLEC-
p.001307: TION, AND PROGRAM EVALUATION.—
p.001307: (1) IN GENERAL.—For the purpose of carrying out section 1948(a) with respect to mental health and the
p.001307: purposes speci- fied in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts
p.001307: appropriated under subsection (a) for a fiscal year.
p.001307: (2) DATA COLLECTION.—The purpose specified in this para- graph is carrying out sections 505(c) and 1971 with
p.001307: respect to mental health.
p.001307: (3) PROGRAM EVALUATION.—The purpose specified in this paragraph is the conduct of evaluations of
p.001307: prevention and treatment programs and services with respect to mental health to determine methods for improving
p.001307: the availability and qual- ity of such programs and services.
p.001307: (c) EARLY SERIOUS MENTAL ILLNESS.—
p.001307: (1) IN GENERAL.—Except as provided in paragraph (2), a State shall expend not less than 10 percent of the
p.001307: amount the State receives for carrying out this section for each fiscal year to support evidence-based programs
p.001307: that address the needs of individuals with early serious mental illness, including psy- chotic disorders,
p.001307: regardless of the age of the individual at onset.
p.001307: (2) STATE FLEXIBILITY.—In lieu of expending 10 percent of the amount the State receives under this section for
p.001307: a fiscal year as required under paragraph (1), a State may elect to ex- pend not less than 20 percent of such
p.001307: amount by the end of such succeeding fiscal year.
p.001307:
p.001307: Subpart II—Block Grants for Prevention and Treatment of Substance Abuse
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
p.001307:
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p.001307:
p.001307:
p.001307:
p.001307:
p.001307: January 30, 2020
p.001307: SEC. 1921. ø300x–21¿ FORMULA GRANTS TO STATES.
p.001307: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Center for
p.001307: Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in
p.001307: accordance with section 1933. The Sec- retary shall make a grant to the State of the allotment made for the
p.001307: State for the fiscal year if the State submits to the Secretary an application in accordance with section
p.001307: 1932.
p.001307: (b) AUTHORIZED ACTIVITIES.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001307: 1931, the State in- volved will expend the grant only for the purpose of carrying out the plan developed
...

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p.001331:
p.001331:
p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
...

p.001361:
p.001361:
p.001361:
p.001361:
p.001361: January 30, 2020
p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
p.001361: (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a
p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
p.001361: (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table—
p.001361: (I) received the vaccine in the United States or in its trust territories,
p.001361: (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person
p.001361: was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the
p.001361: United States or a dependent of such a citizen, or
p.001361: (III) received the vaccine outside the United States or a trust territory and the vaccine was manu-
p.001361: factured by a vaccine manufacturer located in the United States and such person returned to the United States
p.001361: not later than 6 months after the date of the vaccination,
p.001361: (ii) if such person did not receive such a vaccine but contracted polio from another person who received an
p.001361: oral polio vaccine, was a citizen of the United States or a de- pendent of such a citizen,
p.001361: (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the
p.001361: Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the
p.001361: administration of such vaccine, and the first symptom or manifestation of the onset or of the significant
p.001361: aggravation of any such ill- ness, disability, injury, or condition or the death occurred within the
p.001361: time period after vaccine administration set forth in the Vaccine Injury Table, or
p.001361: (ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or condition not set
p.001361: forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
p.001361: (II) sustained, or had significantly aggravated, any ill- ness, disability, injury, or condition set forth in
p.001361: the Vac- cine Injury Table the first symptom or manifestation of the onset or significant aggravation of which
p.001361: did not occur within the time period set forth in the Table but which was caused by a vaccine referred
p.001361: to in subparagraph (A), (D)(i) suffered the residual effects or complications of such illness, disability,
p.001361: injury, or condition for more than
p.001361: 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine,
p.001361: or (iii) suf- fered such illness, disability, injury, or condition from the
p.001361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001361:
p.001361:
p.001361:
p.001361:
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p.001361:
p.001361: Sec. 2112 PUBLIC HEALTH SERVICE ACT 1362
p.001361:
p.001361: vaccine which resulted in inpatient hospitalization and surgical intervention, and
p.001361: (E) has not previously collected an award or settle- ment of a civil action for damages for such
p.001361: vaccine-related injury or death,
p.001361: (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records
p.001361: (including all physicians’ and nurses’ notes and test results), vaccination records associated with the
p.001361: vaccine allegedly causing the in- jury, pre- and post-injury physician or clinic records (including all relevant
p.001361: growth charts and test results), all post-injury in- patient and outpatient records (including all
p.001361: provider notes, test results, and medication records), if applicable, a death cer- tificate, and if applicable,
p.001361: autopsy results, and
p.001361: (3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the
p.001361: petitioner and the reasons for their unavailability.
p.001361: (d) ADDITIONAL INFORMATION.—A petition may also include other available relevant medical records relating to the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
...

p.001367: (e)(2)(C)), or
p.001367: (2) the United States Claims Court fails to enter a judg- ment under this section on a petition within 420
p.001367: days (exclud- ing (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D), and (B) any days the
p.001367: petition is before a special mas- ter as a result of a remand under subsection (e)(2)(C)) after the date on which the
p.001367: petition was filed,
p.001367: the special master or court shall notify the petitioner under such petition that the petitioner may
p.001367: withdraw the petition under sec- tion 2121(b) or the petitioner may choose under section 2121(b) to have
p.001367: the petition remain before the special master or court, as the case may be.
p.001367:
p.001367:
p.001367:
p.001367:
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p.001367:
p.001367:
p.001367: January 30, 2020
p.001367:
p.001367: DETERMINATION OF ELIGIBILITY AND COMPENSATION
p.001367: SEC. 2113. ø300aa–13¿ (a) GENERAL RULE.—
p.001367: (1) Compensation shall be awarded under the Program to a petitioner if the special master or court
p.001367: finds on the record as a whole—
p.001367: (A) that the petitioner has demonstrated by a prepon- derance of the evidence the matters required in the
p.001367: peti- tion by section 2111(c)(1), and
p.001367: (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition,
p.001367: or death de- scribed in the petition is due to factors unrelated to the ad- ministration of the vaccine described in
p.001367: the petition.
p.001367: The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by
p.001367: medical records or by medical opinion.
p.001367: (2) For purposes of paragraph (1), the term ‘‘factors unre- lated to the administration of the vaccine’’—
p.001367: (A) does not include any idiopathic, unexplained, un- known, hypothetical, or undocumentable cause, factor,
p.001367: in- jury, illness, or condition, and
p.001367: (B) may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trau-
p.001367: ma (including birth trauma and related anoxia), or meta- bolic disturbances which have no known relation
p.001367: to the vaccine involved, but which in the particular case are shown to have been the agent or agents
p.001367: principally respon- sible for causing the petitioner’s illness, disability, injury, condition, or death.
p.001367: (b) MATTERS TO BE CONSIDERED.—
p.001367: (1) In determining whether to award compensation to a pe- titioner under the Program, the special master or
p.001367: court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
p.001367: (A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained
p.001367: in the record regarding the nature, causation, and aggravation of
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
p.001367:
p.001367:
p.001367:
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p.001367: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1368
p.001367:
p.001367: the petitioner’s illness, disability, injury, condition, or death, and
p.001367: (B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and
p.001367: conclusions.
p.001367: Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the
p.001367: special master or court. In evaluating the weight to be afforded to any such diag- nosis, conclusion, judgment,
p.001367: test result, report, or summary, the special master or court shall consider the entire record and the course of
p.001367: the injury, disability, illness, or condition until the date of the judgment of the special master or court.
p.001367: (2) The special master or court may find the first symptom or manifestation of onset or significant aggravation
p.001367: of an in- jury, disability, illness, condition, or death described in a peti- tion occurred within the time
p.001367: period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation
p.001367: was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may
p.001367: be made only upon demonstration by a preponderance of the evi- dence that the onset or significant
p.001367: aggravation of the injury, disability, illness, condition, or death described in the petition did in fact
p.001367: occur within the time period described in the Vac- cine Injury Table.
p.001367: (c) RECORD DEFINED.—For purposes of this section, the term ‘‘record’’ means the record established by the
p.001367: special masters of the United States Claims Court in a proceeding on a petition filed under section 2111.
p.001367: VACCINE INJURY TABLE
p.001367: SEC. 2114. ø300aa–14¿ (a) INITIAL TABLE.—The following is a table of vaccines, the injuries, disabilities,
p.001367: illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which
p.001367: the first symptom or manifestation of onset or of the significant aggravation of such injuries,
p.001367: disabilities, ill- nesses, conditions, and deaths is to occur after vaccine administra- tion for purposes of receiving
p.001367: compensation under the Program:
p.001367: VACCINE INJURY TABLE
p.001367: I. DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis
p.001367: Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
p.001367:
p.001367: Illness, disability, injury, or condi- tion covered:
p.001367:
p.001367: A. Anaphylaxis or anaphylactic
p.001367: Time period for first symptom or manifestation of onset or of sig- nificant aggravation after vaccine
p.001367: administration:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367: January 30, 2020
p.001367: shock 24 hours
p.001367: B. Encephalopathy (or encephalitis) 3 days
p.001367: C. Shock-collapse or hypotonic- hyporesponsive collapse 3 days
p.001367: D. Residual seizure disorder in ac-
p.001367: cordance with subsection (b)(2) 3 days
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
p.001367:
p.001367:
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p.001367:
p.001367:
p.001369: 1369
p.001369: PUBLIC HEALTH SERVICE ACT
p.001369: Sec. 2114
p.001369:
p.001369: E. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: II. Measles, mumps, rubella, or any vaccine containing any of the fore- going as a component;
...

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p.001369:
p.001371: 1371
p.001371: PUBLIC HEALTH SERVICE ACT
p.001371: Sec. 2114
p.001371:
p.001371: revision unless the revision specifies that such paragraph is to continue to apply.
p.001371: (c) ADMINISTRATIVE REVISION OF THE TABLE.—
p.001371: (1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury
p.001371: Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a
p.001371: public hearing and at least 180 days of public comment.
p.001371: (2) Any person (including the Advisory Commission on Childhood Vaccines) may petition the Secretary to propose
p.001371: reg- ulations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission,
p.001371: any such petition shall be referred to the Commission for its recommendations. Following—
p.001371: (A) receipt of any recommendation of the Commission,
p.001371: or
p.001371: (B) 180 days after the date of the referral to the Com-
p.001371: mission,
p.001371: whichever occurs first, the Secretary shall conduct a rule- making proceeding on the matters proposed in
p.001371: the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding.
p.001371: (3) A modification of the Vaccine Injury Table under para- graph (1) may add to, or delete from, the list of
p.001371: injuries, dis- abilities, illnesses, conditions, and deaths for which compensa- tion may be provided or may
p.001371: change the time periods for the first symptom or manifestation of the onset or the significant
p.001371: aggravation of any such injury, disability, illness, condition, or death.
p.001371: (4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions
p.001371: for com- pensation under the Program which are filed after the effective date of such regulation.
p.001371: (d) ROLE OF COMMISSION.—Except with respect to a regulation recommended by the Advisory Commission on Childhood
p.001371: Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary
p.001371: has first provided to the Commission a copy of the proposed regulation or revision, re- quested
p.001371: recommendations and comments by the Commission, and afforded the Commission at least 90 days to
p.001371: make such rec- ommendations.
p.001371: (e) 7 ADDITIONAL VACCINES.—
p.001371: (1) VACCINES RECOMMENDED BEFORE AUGUST 1, 1993.—By August 1, 1995, the Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a) to include—
p.001371: (A) vaccines which are recommended to the Secretary by the Centers for Disease Control and Prevention
p.001371: before August 1, 1993, for routine administration to children,
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 7 Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646) provides as follows:
p.001371: ‘‘(3) EFFECTIVE DATE.—A revision by the Secretary under section 2114(e) of the Public Health Service Act
p.001371: (42 U.S.C. 300aa–14(e)) (as amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to
p.001371: provide funds for compensation paid with respect to the vaccine to be added to the vaccine injury table in section
p.001371: 2114(a) of the Public Health Service Act (42 U.S.C. 300aa–14(a)).’’.
...

p.001383: Federal Register as soon as practicable after such date a notice of the reporting requirement.
p.001383: (2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of
p.001383: such vac- cine within which vaccine-related illnesses, disabilities, inju- ries, or conditions, the
p.001383: symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and
p.001383: the manufacturer and lot number of the vaccine.
p.001383: (3) The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of the effective
p.001383: date of this part. 26
p.001383: (c) RELEASE OF INFORMATION.—
p.001383: (1) Information which is in the possession of the Federal Government and State and local governments
p.001383: under this sec- tion and which may identify an individual shall not be made available under section 552
p.001383: of title 5, United States Code, or otherwise, to any person except—
p.001383: (A) the person who received the vaccine, or
p.001383: (B) the legal representative of such person.
p.001383: (2) For purposes of paragraph (1), the term ‘‘information which may identify an individual’’ shall be limited
p.001383: to the name, street address, and telephone number of the person who re- ceived the vaccine and of that
p.001383: person’s legal representative and the medical records of such person relating to the administra- tion of the
p.001383: vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider
p.001383: who administered the vaccine, the date of the vaccination, or information concerning any reported illness,
p.001383: disability, injury, or condition resulting from the administration of the vaccine, any symptom or
p.001383: manifestation of such illness, disability, in- jury, or condition, or death resulting from the
p.001383: administration of the vaccine.
p.001383: (3) Except as provided in paragraph (1), all information re- ported under this section shall be available to the
p.001383: public.
p.001383: VACCINE INFORMATION
p.001383: SEC. 2126. ø300aa–26¿ (a) GENERAL RULE.—Not later than 1 year after the effective date of this part,
p.001383: the Secretary shall de- velop and disseminate vaccine information materials for distribu- tion by health
p.001383: care providers to the legal representatives of any child or to any other individual receiving a vaccine set
p.001383: forth in the Vaccine Injury Table. Such materials shall be published in the Fed- eral Register and may be revised.
p.001383: (b) DEVELOPMENT AND REVISION OF MATERIALS.—Such mate- rials shall be developed or revised—
p.001383:
p.001383:
p.001383:
p.001383:
p.001383: January 30, 2020
p.001383: 25 Effective December 22, 1987.
p.001383: 26 Effective December 22, 1987.
p.001383:
p.001383:
p.001383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001383:
p.001383:
p.001383:
p.001383:
p.001383:
p.001383:
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p.001383:
p.001383:
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p.001383:
p.001383: Sec. 2127 PUBLIC HEALTH SERVICE ACT 1384
p.001383:
p.001383: (1) after notice to the public and 60 days of comment thereon, and
p.001383: (2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers
...

p.001385: 107-296). Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or
p.001385: that Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11,
p.001385: 2002), was incorrectly decided.’’.
p.001385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
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p.001385:
p.001385:
p.001387: 1387
p.001387: PUBLIC HEALTH SERVICE ACT
p.001387: Sec. 2134
p.001387:
p.001387: (2) The term ‘‘legal representative’’ means a parent or an individual who qualifies as a legal guardian
p.001387: under State law.
p.001387: (3) The term ‘‘manufacturer’’ means any corporation, orga- nization, or institution, whether public or private
p.001387: (including Federal, State, and local departments, agencies, and instru- mentalities), which manufactures,
p.001387: imports, processes, or dis- tributes under its label any vaccine set forth in the Vaccine In- jury Table, except
p.001387: that, for purposes of section 2128, such term shall include the manufacturer of any other vaccine covered by that
p.001387: section. The term ‘‘manufacture’’ means to manufacture, import, process, or distribute a vaccine.
p.001387: (4) The term ‘‘significant aggravation’’ means any change for the worse in a preexisting condition which results
p.001387: in mark- edly greater disability, pain, or illness accompanied by sub- stantial deterioration of health.
p.001387: (5) The term ‘‘vaccine-related injury or death’’ means an illness, injury, condition, or death associated with
p.001387: one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include
p.001387: an illness, injury, condition, or death associated with an adulterant or contaminant inten- tionally added
p.001387: to such a vaccine.
p.001387: (6)(A) The term ‘‘Advisory Commission on Childhood Vac- cines’’ means the Commission established under
p.001387: section 2119.
p.001387: (B) The term ‘‘Vaccine Injury Table’’ means the table set out in section 2114.
p.001387: TERMINATION OF PROGRAM
p.001387: SEC. 2134. ø300aa–34¿ (a) REVIEWS.—The Secretary shall re- view the number of awards of compensation made
p.001387: under the pro- gram to petitioners under section 2111 for vaccine-related injuries and deaths associated
p.001387: with the administration of vaccines on or after the effective date of this part 29 as follows:
p.001387: (1) The Secretary shall review the number of such awards made in the 12-month period beginning on the effective
p.001387: date of this part. 29
p.001387: (2) At the end of each 3-month period beginning after the expiration of the 12-month period referred to in
p.001387: paragraph (1) the Secretary shall review the number of such awards made in the 3-month period.
p.001387: (b) REPORT.—
p.001387: (1) If in conducting a review under subsection (a) the Sec- retary determines that at the end of the period
p.001387: reviewed the total number of awards made by the end of that period and ac- cepted under section 2121(a) exceeds
p.001387: the number of awards listed next to the period reviewed in the table in paragraph (2)—
p.001387: (A) the Secretary shall notify the Congress of such de- termination, and
p.001387: (B) beginning 180 days after the receipt by Congress of a notification under paragraph (1), no petition for a
p.001387: vac- cine-related injury or death associated with the adminis-
p.001387:
p.001387:
p.001387:
p.001387: January 30, 2020
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p.001507:
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p.001507:
p.001507:
p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
...

p.001581: (I) medical management standards based on medical necessity or appropriateness, or whether a treatment is
p.001581: experimental or investigative;
p.001581: (II) limitations with respect to prescription drug formulary design; and
p.001581: (III) use of fail-first or step therapy protocols;
p.001581: (ii) examples of methods of determining—
p.001581: (I) network admission standards (such as credentialing); and
p.001581: (II) factors used in provider reimbursement methodologies (such as service type, geographic market, demand
p.001581: for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to
p.001581: network adequacy;
p.001581: (iii) examples of sources of information that may serve as evidentiary standards for the purposes of
p.001581: making determinations regarding the development and application of nonquantitative treatment limita-
p.001581: tions;
p.001581: (iv) examples of specific factors, and the evi- dentiary standards used to evaluate such factors, used by
p.001581: such plans or issuers in performing a nonquantita- tive treatment limitation analysis;
p.001581: (v) examples of how specific evidentiary standards may be used to determine whether treatments are con- sidered
p.001581: experimental or investigative;
p.001581: (vi) examples of how specific evidentiary stand- ards may be applied to each service category or classi- fication
p.001581: of benefits;
p.001581: (vii) examples of methods of reaching appropriate coverage determinations for new mental health or sub- stance
p.001581: use disorder treatments, such as evidence- based early intervention programs for individuals with a serious
p.001581: mental illness and types of medical manage- ment techniques;
p.001581: (viii) examples of methods of reaching appropriate coverage determinations for which there is an indirect relationship
p.001581: between the covered mental health or substance use disorder benefit and a traditional cov- ered
p.001581: medical and surgical benefit, such as residential treatment or hospitalizations involving voluntary or
p.001581: involuntary commitment; and
p.001581: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001581:
p.001581:
p.001581:
p.001581:
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p.001581:
p.001581: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1582
p.001581:
p.001581: (ix) additional illustrative examples of methods, processes, strategies, evidentiary standards, and other factors
p.001581: for which the Secretary determines that addi- tional guidance is necessary to improve compliance with this
p.001581: section, section 712 of the Employee Retire- ment Income Security Act of 1974, or section 9812 of the
p.001581: Internal Revenue Code of 1986, as applicable.
p.001581: (D) PUBLIC COMMENT.—Prior to issuing any final guid- ance under this paragraph, the Secretary shall provide a
p.001581: public comment period of not less than 60 days during which any member of the public may provide comments on a
p.001581: draft of the guidance.
p.001581: (b) CONSTRUCTION.—Nothing in this section shall be construed—
p.001581: (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance
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p.001583:
p.001583:
p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
p.001585: (2) DEPENDENT CHILD DESCRIBED.—A dependent child de- scribed in this paragraph is, with respect to a
p.001585: group health plan or individual health insurance coverage, a beneficiary under the plan who—
p.001585: (A) is a dependent child, under the terms of the plan or coverage, of a participant or beneficiary under the
p.001585: plan or coverage; and
p.001585:
...

p.001611: (A) Coverage only for accident, or disability income in- surance, or any combination thereof.
p.001611: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001611:
p.001611:
p.001611:
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p.001611:
p.001611:
p.001613: 1613
p.001613: PUBLIC HEALTH SERVICE ACT
p.001613: Sec. 2791
p.001613:
p.001613: (B) Coverage issued as a supplement to liability insurance.
p.001613: (C) Liability insurance, including general liability in- surance and automobile liability insurance.
p.001613: (D) Workers’ compensation or similar insurance.
p.001613: (E) Automobile medical payment insurance.
p.001613: (F) Credit-only insurance.
p.001613: (G) Coverage for on-site medical clinics.
p.001613: (H) Other similar insurance coverage, specified in reg- ulations, under which benefits for medical care are
p.001613: sec- ondary or incidental to other insurance benefits.
p.001613: (2) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED SEPARATELY.—
p.001613: (A) Limited scope dental or vision benefits.
p.001613: (B) Benefits for long-term care, nursing home care, home health care, community-based care, or any combina- tion
p.001613: thereof.
p.001613: (C) Such other similar, limited benefits as are speci- fied in regulations.
p.001613: (3) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS INDEPENDENT, NONCOORDINATED BENEFITS.—
p.001613: (A) Coverage only for a specified disease or illness.
p.001613: (B) Hospital indemnity or other fixed indemnity insurance.
p.001613: (4) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS SEPARATE INSURANCE POLICY.—Medicare
p.001613: supplemental health insurance (as defined under section 1882(g)(1) of the So- cial Security Act), coverage
p.001613: supplemental to the coverage pro- vided under chapter 55 of title 10, United States Code, and similar
p.001613: supplemental coverage provided to coverage under a group health plan.
p.001613: (d) 29 OTHER DEFINITIONS.—
p.001613: (1) APPLICABLE STATE AUTHORITY.—The term ‘‘applicable State authority’’ means, with respect to a health
p.001613: insurance issuer in a State, the State insurance commissioner or official or officials designated by the State
p.001613: to enforce the requirements of this title for the State involved with respect to such issuer.
p.001613: (2) BENEFICIARY.—The term ‘‘beneficiary’’ has the meaning given such term under section 3(8) of the Employee Retirement
p.001613: Income Security Act of 1974.
p.001613: (3) BONA FIDE ASSOCIATION.—The term ‘‘bona fide associa- tion’’ means, with respect to health insurance coverage
p.001613: offered in a State, an association which—
p.001613: (A) has been actively in existence for at least 5 years;
p.001613: (B) has been formed and maintained in good faith for purposes other than obtaining insurance;
p.001613: (C) does not condition membership in the association on any health status-related factor relating to an
p.001613: indi- vidual (including an employee of an employer or a depend- ent of an employee);
p.001613:
p.001613:
p.001613:
p.001613:
p.001613:
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p.001717: list main- tained by the Department of Homeland Security shall qualify as an eligible WTC responder.
p.001717: Before enrolling any individual as a WTC responder in the WTC Program under paragraph (3), the Administrator, in
p.001717: consultation with the Secretary of Home- land Security, shall determine whether the individual is on such list.
p.001717: (b) MONITORING BENEFITS.—
p.001717: (1) IN GENERAL.—In the case of an enrolled WTC re- sponder (other than one described in subsection
p.001717: (a)(2)(A)(ii)), the WTC Program shall provide for monitoring benefits that include monitoring consistent
p.001717: with protocols approved by the WTC Program Administrator and including clinical examina- tions and
p.001717: long-term health monitoring and analysis. In the case of an enrolled WTC responder who is an active
p.001717: member of the Fire Department of New York City, the responder shall receive such benefits as part of the
p.001717: individual’s periodic com- pany medical exams.
p.001717: (2) PROVISION OF MONITORING BENEFITS.—The monitoring benefits under paragraph (1) shall be provided through
p.001717: the Clinical Center of Excellence for the type of individual involved or, in the case of an individual residing
p.001717: outside the New York metropolitan area, under an arrangement under section 3313.
p.001717: SEC. 3312. ø42 U.S.C. 300mm–22¿ TREATMENT OF ENROLLED WTC RE- SPONDERS FOR WTC-RELATED HEALTH CONDITIONS.
p.001717: (a) WTC-RELATED HEALTH CONDITION DEFINED.—
p.001717: (1) IN GENERAL.—For purposes of this title, the term ‘‘WTC-related health condition’’ means a condition
p.001717: that—
p.001717: (A)(i) is an illness or health condition for which expo- sure to airborne toxins, any other hazard, or any
p.001717: other ad- verse condition resulting from the September 11, 2001, ter- rorist attacks, based on an examination by
p.001717: a medical pro- fessional with experience in treating or diagnosing the health conditions included in the
p.001717: applicable list of WTC-re- lated health conditions, is substantially likely to be a sig- nificant factor in
p.001717: aggravating, contributing to, or causing the illness or health condition, as determined under para- graph (2); or
p.001717: (ii) is a mental health condition for which such at- tacks, based on an examination by a medical
p.001717: professional with experience in treating or diagnosing the health condi- tions included in the applicable list of
p.001717: WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to,
p.001717: or causing the condition, as determined under paragraph (2); and
p.001717: (B) is included in the applicable list of WTC-related health conditions or—
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001717:
p.001717:
p.001717:
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p.001717:
p.001717: Sec. 3312 PUBLIC HEALTH SERVICE ACT 1718
p.001717: (i) with respect to a WTC responder, is provided certification of coverage under subsection (b)(2)(B)(iii); or
p.001717:
p.001717:
p.001717:
p.001717:
p.001717:
p.001717:
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p.001717:
p.001717:
p.001717: January 30, 2020
p.001717: (ii) with respect to a screening-eligible WTC sur- vivor or certified-eligible WTC survivor, is provided
p.001717: certification of coverage under subsection (b)(2)(B)(iii), as applied under section 3322(a).
p.001717: In the case of a WTC responder described in section 3311(a)(2)(A)(ii) (relating to a
p.001717: surviving immediate family member of a firefighter), such term does not include an illness or health condition
p.001717: described in subparagraph (A)(i).
p.001717: (2) DETERMINATION.—The determination under paragraph
p.001717: (1) or subsection (b) of whether the September 11, 2001, ter- rorist attacks were substantially likely
p.001717: to be a significant fac- tor in aggravating, contributing to, or causing an individual’s illness or
p.001717: health condition shall be made based on an assess- ment of the following:
p.001717: (A) The individual’s exposure to airborne toxins, any other hazard, or any other adverse condition
p.001717: resulting from the terrorist attacks. Such exposure shall be—
p.001717: (i) evaluated and characterized through the use of a standardized, population-appropriate questionnaire approved by
p.001717: the Director of the National Institute for Occupational Safety and Health; and
p.001717: (ii) assessed and documented by a medical profes- sional with experience in treating or diagnosing health conditions
p.001717: included on the list of WTC-related health conditions.
p.001717: (B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall be—
p.001717: (i) assessed through the use of a standardized, population-appropriate medical questionnaire ap- proved
p.001717: by the Director of the National Institute for Oc- cupational Safety and Health and a medical examina- tion; and
p.001717: (ii) diagnosed and documented by a medical pro- fessional described in subparagraph (A)(ii).
p.001717: (3) LIST OF HEALTH CONDITIONS FOR WTC RESPONDERS.— The list of health conditions for WTC responders
p.001717: consists of the following:
p.001717: (A) AERODIGESTIVE DISORDERS.—
p.001717: (i) Interstitial lung diseases.
p.001717: (ii) Chronic respiratory disorder—fumes/vapors.
p.001717: (iii) Asthma.
p.001717: (iv) Reactive airways dysfunction syndrome (RADS).
p.001717: (v) WTC-exacerbated chronic obstructive pul- monary disease (COPD).
p.001717: (vi) Chronic cough syndrome.
p.001717: (vii) Upper airway hyperreactivity.
p.001717: (viii) Chronic rhinosinusitis.
p.001717: (ix) Chronic nasopharyngitis.
p.001717: (x) Chronic laryngitis.
...

p.001723:
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p.001723:
p.001723: January 30, 2020
p.001723:
p.001723: (including any prior authorization requirement), and a process for appeal of a determination under
p.001723: subsection (c)(3).
p.001723: (4) SCOPE OF TREATMENT COVERED.—
p.001723: (A) IN GENERAL.—The scope of treatment covered under this subsection includes services of physicians
p.001723: and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and
p.001723: outpatient hospital services, and other medically necessary treatment.
p.001723: (B) PHARMACEUTICAL COVERAGE.—With respect to en- suring coverage of medically necessary outpatient prescrip- tion
p.001723: drugs, such drugs shall be provided, under arrange- ments made by the WTC Program Administrator, directly
p.001723: through participating Clinical Centers of Excellence or through one or more outside vendors.
p.001723: (C) TRANSPORTATION EXPENSES FOR NATIONWIDE NET- WORK.—The WTC Program Administrator may provide for necessary and
p.001723: reasonable transportation and expenses in- cident to the securing of medically necessary treatment through
p.001723: the nationwide network under section 3313 in- volving travel of more than 250 miles and for which pay-
p.001723: ment is made under this section in the same manner in which individuals may be furnished necessary and
p.001723: reason- able transportation and expenses incident to services in- volving travel of more than 250 miles
p.001723: under regulations implementing section 3629(c) of the Energy Employees Oc- cupational Illness Compensation Program Act
p.001723: of 2000 (title XXXVI of Public Law 106–398; 42 U.S.C. 7384t(c)).
p.001723: (5) PROVISION OF TREATMENT PENDING CERTIFICATION.— With respect to an enrolled WTC responder for whom a deter-
p.001723: mination is made by an examining physician under paragraph
p.001723: (1) or (2), but for whom the WTC Program Administrator has not yet determined whether to certify the
p.001723: determination, the WTC Program Administrator may establish by rule a process through which the Administrator
p.001723: may approve the provision of medical treatment under this subsection (and payment under subsection (c)) with
p.001723: respect to such responder and such re- sponder’s WTC-related health condition (under such terms and conditions as
p.001723: the Administrator may provide) until the Admin- istrator makes a decision on whether to certify the determina- tion.
p.001723: (c) PAYMENT FOR INITIAL HEALTH EVALUATION, MONITORING,
p.001723: AND TREATMENT OF WTC-RELATED HEALTH CONDITIONS.—
p.001723: (1) MEDICAL TREATMENT.—
p.001723: (A) USE OF FECA PAYMENT RATES.—
p.001723: (i) IN GENERAL.—Subject to clause (ii):
p.001723: (I) Subject to subparagraphs (B) and (C), the WTC Program Administrator shall reimburse costs for
p.001723: medically necessary treatment under this title for WTC-related health conditions according to the payment rates
p.001723: that would apply to the pro- vision of such treatment and services by the facil- ity under the Federal Employees
p.001723: Compensation Act.
p.001723: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001723:
p.001723:
p.001723:
p.001723:
p.001723:
p.001723:
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p.001731: WTC Program from the World Trade Cen- ter Health Program Fund.
p.001731: (b) WORKERS’ COMPENSATION PAYMENT.—
p.001731: (1) IN GENERAL.—Subject to paragraph (2), payment for treatment under parts 1 and 2 of this subtitle of
p.001731: a WTC-re- lated health condition of an individual that is work-related shall be reduced or recouped to
p.001731: the extent that the WTC Pro- gram Administrator determines that payment has been made, or can reasonably
p.001731: be expected to be made, under a workers’ compensation law or plan of the United States, a State, or a
p.001731: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001731:
p.001731:
p.001731:
p.001731:
p.001731:
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p.001731:
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p.001731:
p.001731:
p.001733: 1733
p.001733: PUBLIC HEALTH SERVICE ACT
p.001733: Sec. 3331
p.001733:
p.001733:
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p.001733:
p.001733:
p.001733:
p.001733: January 30, 2020
p.001733: locality, or other work-related injury or illness benefit plan of the employer of such individual, for such
p.001733: treatment. The provi- sions of clauses (iii), (iv), (v), and (vi) of paragraph (2)(B) of sec- tion 1862(b) of the
p.001733: Social Security Act and paragraphs (3) and
p.001733: (4) of such section shall apply to the recoupment under this subsection of a payment to the WTC Program (with
p.001733: respect to a workers’ compensation law or plan, or other work-related in- jury or illness plan of the employer
p.001733: involved, and such indi- vidual) in the same manner as such provisions apply to the re- imbursement of a payment
p.001733: under section 1862(b)(2) of such Act to the Secretary (with respect to such a law or plan and an in- dividual entitled
p.001733: to benefits under title XVIII of such Act) ex- cept that any reference in such paragraph (4) to payment rates
p.001733: under title XVIII of the Social Security Act shall be deemed a reference to payment rates under this title.
p.001733: (2) EXCEPTION.—Paragraph (1) shall not apply for any quarter, with respect to any workers’ compensation
p.001733: law or plan, including line of duty compensation, to which New York City is obligated to make payments,
p.001733: if, in accordance with terms specified under the contract under subsection (d)(1)(A), New York City has made
p.001733: the full payment required under such contract for such quarter.
p.001733: (3) RULES OF CONSTRUCTION.—Nothing in this title shall be construed to affect, modify, or relieve any
p.001733: obligations under a worker’s compensation law or plan, other work-related injury or illness benefit plan of an
p.001733: employer, or any health insurance plan.
p.001733: (c) HEALTH INSURANCE COVERAGE.—
p.001733: (1) IN GENERAL.—In the case of an individual who has a WTC-related health condition that is not work-related
p.001733: and has health coverage for such condition through any public or pri- vate health plan (including health
p.001733: benefits under title XVIII, XIX, or XXI of the Social Security Act) the provisions of section 1862(b) of the Social
p.001733: Security Act shall apply to such a health plan and such individual in the same manner as they apply to group health
p.001733: plan and an individual entitled to benefits under title XVIII of such Act pursuant to section 226(a) of such
p.001733: Act. Any costs for items and services covered under such plan that are not reimbursed by such health plan, due to the
p.001733: application of deductibles, copayments, coinsurance, other cost sharing, or otherwise, are reimbursable under
p.001733: this title to the extent that they are covered under the WTC Program. The program under this title shall not be treated
p.001733: as a legally liable party for pur- poses of applying section 1902(a)(25) of the Social Security Act.
p.001733: (2) RECOVERY BY INDIVIDUAL PROVIDERS.—Nothing in para- graph (1) shall be construed as requiring an entity
p.001733: providing monitoring and treatment under this title to seek reimburse- ment under a health plan with
p.001733: which the entity has no con- tract for reimbursement.
p.001733: (3) MAINTENANCE OF REQUIRED MINIMUM ESSENTIAL COV- ERAGE.—No payment may be made for monitoring and
p.001733: treat- ment under this title for an individual for a month (beginning with July 2014) if with respect to such month the
p.001733: individual—
...

p.001735: WTC Program Administrator shall—
p.001735: (A) provide New York City with an estimate of such
p.001735: amount of the required contribution at the beginning of such quarter and with an updated estimate
p.001735: of such amount at the beginning of each of the subsequent 2 quar- ters;
p.001735: (B) bill such amount directly to New York City; and
p.001735: (C) certify periodically, for purposes of this subsection, whether or not New York City has paid the amount
p.001735: so billed.
p.001735: Such amount shall initially be estimated by the WTC Program Administrator and shall be subject to adjustment and
p.001735: reconcili- ation based upon actual expenditures in carrying out this title.
p.001735: (3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed as authorizing the WTC Administrator,
p.001735: with respect to a fiscal year, to reduce the numerical limitation under section 3311(a)(4) or 3321(a)(3)
p.001735: for such fiscal year if New York City fails to comply with paragraph (1) for a cal- endar quarter in
p.001735: such fiscal year.
p.001735: (e) WORK-RELATED DESCRIBED.—For the purposes of this sec- tion, a WTC-related health condition shall be treated
p.001735: as a condition that is work-related if—
p.001735: (1) the condition is diagnosed in an enrolled WTC re- sponder, or in an individual who qualifies as a
p.001735: certified-eligible WTC survivor on the basis of being a rescue, recovery, or cleanup worker; or
p.001735: (2) with respect to the condition the individual has filed and had established a claim under a workers’
p.001735: compensation law or plan of the United States or a State, or other work-re- lated injury or illness
p.001735: benefit plan of the employer of such indi- vidual.
p.001735: SEC. 3332. ø42 U.S.C. 300mm–42¿ ADMINISTRATIVE ARRANGEMENT AU- THORITY.
p.001735: The WTC Program Administrator may enter into arrange- ments with other government agencies, insurance
p.001735: companies, or other third-party administrators to provide for timely and accurate processing of claims under sections
p.001735: 3312, 3313, 3322, and 3323.
p.001735:
p.001735:
p.001735: January 30, 2020 As Amended Through P.L. 116-94,
p.001735: Enacted December 20, 2019
p.001735:
p.001735:
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p.001735:
p.001735:
p.001735: Sec. 3341 PUBLIC HEALTH SERVICE ACT
p.001735:
p.001735: Subtitle C—Research Into Conditions
p.001736: 1736
p.001736:
p.001736: SEC. 3341. ø42 U.S.C. 300mm–51¿ RESEARCH REGARDING CERTAIN HEALTH CONDITIONS RELATED TO SEPTEMBER 11
p.001736: TER- RORIST ATTACKS.
p.001736: (a) IN GENERAL.—With respect to individuals, including en- rolled WTC responders and certified-eligible WTC
p.001736: survivors, receiv- ing monitoring or treatment under subtitle B, the WTC Program Administrator shall conduct
p.001736: or support—
p.001736: (1) research on physical and mental health conditions that may be related to the September 11, 2001, terrorist attacks;
p.001736: (2) research on diagnosing WTC-related health conditions of such individuals, in the case of conditions
p.001736: for which there has been diagnostic uncertainty; and
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p.000217: discovery of the loss described in the clause.
p.000217: (B) SCOPE.—The immunity under paragraph (1) ap- plies to any claim for loss that has a causal
p.000217: relationship with the administration to or use by an individual of a cov- ered countermeasure, including a causal
p.000217: relationship with the design, development, clinical testing or investigation, manufacture, labeling,
p.000217: distribution, formulation, pack- aging, marketing, promotion, sale, purchase, donation, dis- pensing, prescribing,
p.000217: administration, licensing, or use of such countermeasure.
p.000217: (3) CERTAIN CONDITIONS.—Subject to the other provisions of this section, immunity under paragraph (1)
p.000217: with respect to a covered countermeasure applies only if—
p.000217: (A) the countermeasure was administered or used dur- ing the effective period of the declaration that was
p.000217: issued under subsection (b) with respect to the countermeasure;
p.000217: (B) the countermeasure was administered or used for the category or categories of diseases, health conditions,
p.000217: or threats to health specified in the declaration; and
p.000217: (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to
p.000217: the administration or use of the countermeasure, the counter- measure was administered to or used by an
p.000217: individual who—
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p.000217: January 30, 2020
p.000217: (i) was in a population specified by the declara- tion; and
p.000217: (ii) was at the time of administration physically present in a geographic area specified by the declara-
p.000217: tion or had a connection to such area specified in the declaration.
p.000217: (4) APPLICABILITY OF CERTAIN CONDITIONS.—With respect to immunity under paragraph (1) and subject to the other
p.000217: pro- visions of this section:
p.000217: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000217:
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p.000217: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 218
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p.000217: January 30, 2020
p.000217:
p.000217: (A) In the case of a covered person who is a manufac- turer or distributor of the covered countermeasure
p.000217: in- volved, the immunity applies without regard to whether such countermeasure was administered to or used
p.000217: by an individual in accordance with the conditions described in paragraph (3)(C).
p.000217: (B) In the case of a covered person who is a program planner or qualified person with respect to the
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p.000219: 219
p.000219: PUBLIC HEALTH SERVICE ACT
p.000219: Sec. 319F–3
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p.000219: January 30, 2020
p.000219: (C) the population or populations of individuals for which subsection (a) is in effect with respect to the
p.000219: admin- istration or use of the countermeasure (which may be a specification that such subsection
p.000219: applies without geo- graphic limitation to all individuals);
p.000219: (D) the geographic area or areas for which subsection
p.000219: (a) is in effect with respect to the administration or use of the countermeasure (which may be a specification
p.000219: that such subsection applies without geographic limitation), in- cluding, with respect to individuals in the
p.000219: populations identified under subparagraph (C), a specification, as de- termined appropriate by the Secretary, of
p.000219: whether the dec- laration applies only to individuals physically present in such areas or whether in
p.000219: addition the declaration applies to individuals who have a connection to such areas, which connection is described
p.000219: in the declaration; and
p.000219: (E) whether subsection (a) is effective only to a par- ticular means of distribution as provided in
p.000219: subsection (a)(5) for obtaining the countermeasure, and if so, the par- ticular means to which such subsection is
p.000219: effective.
p.000219: (3) EFFECTIVE PERIOD OF DECLARATION.—
p.000219: (A) FLEXIBILITY OF PERIOD.—The Secretary may, in de- scribing periods under paragraph (2)(B), have different pe- riods
p.000219: for different covered persons to address different logistical, practical or other differences in
p.000219: responsibilities.
p.000219: (B) ADDITIONAL TIME TO BE SPECIFIED.—In each dec- laration under paragraph (1), the Secretary, after con-
p.000219: sulting, to the extent the Secretary deems appropriate, with the manufacturer of the covered
p.000219: countermeasure, shall also specify a date that is after the ending date speci- fied under paragraph (2)(B) and that
p.000219: allows what the Sec- retary determines is—
p.000219: (i) a reasonable period for the manufacturer to ar- range for disposition of the covered countermeasure,
p.000219: including the return of such product to the manufac- turer; and
p.000219: (ii) a reasonable period for covered persons to take such other actions as may be appropriate to limit ad-
p.000219: ministration or use of the covered countermeasure.
p.000219: (C) ADDITIONAL PERIOD FOR CERTAIN STRATEGIC NA- TIONAL STOCKPILE COUNTERMEASURES.—With respect to a
p.000219: covered countermeasure that is in the stockpile under sec- tion 319F-2, if such countermeasure was the subject
...

p.000425: described in sub- section (d)(1)(A) meets the applicable requirements of sub- section (d)(1) with respect
p.000425: to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years.
p.000425: (2) TEMPORARY RENEWAL CERTIFICATE.—The Secretary may issue a temporary renewal certificate, for a
p.000425: period of not to exceed 45 days, to a facility seeking reaccreditation if the ac- creditation body has issued an
p.000425: accreditation extension, for a period of not to exceed 45 days, for any of the following:
p.000425: (A) The facility has submitted the required materials to the accreditation body within the
p.000425: established time frames for the submission of such materials but the ac- creditation body is unable to
p.000425: complete the reaccreditation process before the certification expires.
p.000425: (B) The facility has acquired additional or replacement equipment, or has had significant personnel changes or
p.000425: other unforeseen situations that have caused the facility to be unable to meet reaccreditation timeframes, but
p.000425: in the opinion of the accreditation body have not compromised the quality of mammography.
p.000425: (3) LIMITED PROVISIONAL CERTIFICATE.—The Secretary may, upon the request of an accreditation body, issue a
p.000425: limited provisional certificate to an entity to enable the entity to con- duct examinations for
p.000425: educational purposes while an onsite visit from an accreditation body is in progress. Such certificate shall be
p.000425: valid only during the time the site visit team from the accreditation body is physically in the facility, and
p.000425: in no case shall be valid for longer than 72 hours. The issuance of a cer- tificate under this paragraph, shall
p.000425: not preclude the entity from qualifying for a provisional certificate under paragraph (4).
p.000425:
p.000425:
p.000425:
p.000425:
p.000425: January 30, 2020
p.000425: 71 So in law. The article ‘‘a’’ appears before both ‘‘temporary renewal certificate’’ and ‘‘limited provisional
p.000425: certificate’’. See section 2(1)(C) of Public Law 108–365 (118 Stat. 1738).
p.000425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000425:
p.000425:
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p.000425:
p.000425: Sec. 354 PUBLIC HEALTH SERVICE ACT 426
p.000425:
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p.000425: January 30, 2020
p.000425:
p.000425: (4) PROVISIONAL CERTIFICATE.—The Secretary may issue a provisional certificate for an entity to enable the entity to
...

p.000957: individual employed in accordance with such methods), as are found by the Surgeon General to be
p.000957: necessary for the proper and efficient operation of the plan;
p.000957: (9) provide for affording to every applicant for a construc- tion or modernization project an opportunity
p.000957: for a hearing be- fore the State agency;
p.000957: (10) provide that the State agency will make such reports, in such form and containing such information, as the Surgeon
p.000957: General may from time to time reasonably require, and will keep such records and afford such access
p.000957: thereto as the Sur- geon General may find necessary to assure the correctness and verification of such reports;
p.000957: (11) provide that the Comptroller General of the United States or his duly authorized representatives shall
p.000957: have access for the purpose of audit and examination to the records speci- fied in paragraph (10);
p.000957: (12) provide that the State agency will from time to time, but not less often than annually, review its State
p.000957: plan and sub- mit to the Surgeon General any modifications thereof which it considers necessary; and
p.000957: (13) effective July 1, 1971, provide that before any project for construction or modernization of any general hospital
p.000957: is ap- proved by the State agency there will be reasonable assurance of adequate provision for extended care services
p.000957: (as determined in accordance with regulations) to patients of such hospital when such services are
p.000957: medically appropriate for them, with such services being provided in facilities which (A) are struc-
p.000957: turally part of, physically connected with, or in immediate proximity to, such hospital, and (B) either (i) are
p.000957: under the su- pervision of the professional staff of such hospital or (ii) have organized medical staffs and
p.000957: have in effect transfer agreements with such hospital; except that the Secretary may, at the re- quest of the
p.000957: State agency, waive compliance with clause (A) or (B), or both such clauses, as the case may be, in the
p.000957: case of any project if the State agency has determined that compliance with such clause or clauses in such case would
p.000957: be inadvisable.
p.000957: (b) The Surgeon General shall approve any State plan and any modification thereof which complies with the
p.000957: provisions of sub- section (a). If any such plan or modification thereof shall have been disapproved by the Surgeon
p.000957: General for failure to comply with sub- section (a), the Federal Hospital Council shall, upon request of the
p.000957: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000957:
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p.000959: PUBLIC HEALTH SERVICE ACT
p.000959: Sec. 605
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p.000959: State agency, afford it an opportunity for hearing. If such Council determines that the plan or
p.000959: modification complies with the provi- sions of such subsection, the Surgeon General shall thereupon ap-
p.000959: prove such plan or modification.
p.000959: APPROVAL OF PROJECTS FOR CONSTRUCTION OR MODERNIZATION
p.000959: SEC. 605. ø291e¿ (a) For each project pursuant to a State plan approved under this part, there shall be submitted to
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p.001071: that meet at least 4 of the criteria described in paragraph (3) shall qualify for a funding preference under
p.001071: this section.
p.001071: (2) DEFINITION.—As used in this subsection, the term ‘‘new program’’ means any program that has graduated less
p.001071: than three classes. Upon graduating at least three classes, a pro- gram shall have the capability to provide
p.001071: the information nec- essary to qualify the program for the general funding pref- erences described in
p.001071: subsection (a).
p.001071: (3) CRITERIA.—The criteria referred to in paragraph (1) are the following:
p.001071: (A) The mission statement of the program identifies a specific purpose of the program as being the preparation of
p.001071: health professionals to serve underserved populations.
p.001071: (B) The curriculum of the program includes content which will help to prepare practitioners to serve
p.001071: under- served populations.
p.001071: (C) Substantial clinical training experience is required under the program in medically underserved communities.
p.001071: (D) A minimum of 20 percent of the clinical faculty of the program spend at least 50 percent of their time
p.001071: pro- viding or supervising care in medically underserved com- munities.
p.001071: (E) The entire program or a substantial portion of the program is physically located in a medically underserved
p.001071: community.
p.001071: (F) Student assistance, which is linked to service in medically underserved communities following
p.001071: graduation, is available to the students in the program.
p.001071: (G) The program provides a placement mechanism for deploying graduates to medically underserved commu-
p.001071: nities.
p.001071: SEC. 792. ø295k¿ HEALTH PROFESSIONS DATA.
p.001071: (a) IN GENERAL.—The Secretary shall establish a program, in- cluding a uniform health professions data reporting
p.001071: system, to col- lect, compile, and analyze data on health professions personnel which program shall initially
p.001071: include data respecting all physicians and dentists in the States. The Secretary is authorized to expand the
p.001071: program to include, whenever he determines it necessary, the collection, compilation, and analysis of
p.001071: data respecting phar- macists, optometrists, podiatrists, veterinarians, public health per- sonnel, audiologists,
p.001071: speech pathologists, health care administra- tion personnel, nurses, allied health personnel, medical
p.001071: tech- nologists, chiropractors, clinical psychologists, professional coun- selors, and any other health personnel
p.001071: in States designated by the Secretary to be included in the program. Such data shall include data respecting
p.001071: the training, licensure status (including perma- nent, temporary, partial, limited, or institutional),
p.001071: place or places of practice, professional specialty, practice characteristics, place and date of birth, sex,
p.001071: and socioeconomic background of health pro- fessions personnel and such other demographic information regard- ing
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Health / Physically Ill

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p.000001: to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the
p.000001: period of such attendance, whichever is greater. Such subsequent period of service shall com- mence upon the
p.000001: cessation of such attendance and of any further continuous period of training duty for which no tuition and fees
p.000001: are paid by the Service and which is part of the officer’s prescribed for- mal training program, whether such
p.000001: further training is at Service facility or otherwise. The Surgeon General may waive, in whole or in part, any
p.000001: payment which may be required by this subsection upon a determination that such payment would be
p.000001: inequitable or would not be in public interest.
p.000001: (c) A commissioned officer may be placed in leave without pay
p.000001: status while attending an educational institution or training pro- gram whenever the Secretary determines that
p.000001: such status is in the best interest of the Service. For purposes of computation of basic pay, promotion,
p.000001: retirement, compensation for injury or death, and the benefits provided by sections 212 and 224, an
p.000001: officer in such status pursuant to the preceding sentence shall be considered as performing service in
p.000001: the Service and shall have an active service obligation as set forth in subsection (b) of this section.
p.000001: ANNUAL AND SICK LEAVE
p.000001: SEC. 219. ø210–1¿ (a) In accordance with regulations of the President, commissioned officers of the
p.000001: Regular Corps and officers of the Reserve Corps on active duty may be granted annual leave and sick
p.000001: leave without any deductions from their pay and allow- ances: Provided, That such regulations shall not
p.000001: authorize annual leave to be accumulated in excess of sixty days.
p.000001: (d) 9 For purposes of this section the term ‘‘accumulated annual leave’’ means unused accrued annual leave
p.000001: carried forward from one leave year into a succeeding leave year, and the term ‘‘accrued annual leave’’ means the
p.000001: annual leave accruing to an officer during one leave year.
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p.000001: 9 Former subsection (b) was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Sec- tion 503(b) of title
p.000001: 37, United States Code, now applies to the matter with which former sub- section (b) was concerned. Former
p.000001: subsection (c) was repealed by section 311 of Public Law 96– 76 (93 Stat. 586).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 220 PUBLIC HEALTH SERVICE ACT 24
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Health / Pregnant

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p.000127: January 30, 2020
p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
p.000127: regardless of the outcome of the pregnancy.
p.000127: (2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian tribes, and tribal organizations that participate in the
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p.000131: January 30, 2020
p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
p.000131: (1) provide technical and consultative assistance to entities receiving grants under subsection (b);
p.000131: (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease
p.000131: Control and Pre- vention;
p.000131: (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy
p.000131: laws; and
p.000131: (4) coordinate with the National Coordinator for Health In- formation Technology, as appropriate, to assist
p.000131: States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such
p.000131: recognized standards are available, in order to facilitate interoperability between such systems and health
p.000131: information technology systems, in- cluding certified health information technology.
p.000131: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000131: to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
p.000131: SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.000131: (a) GRANTS.—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for
p.000131: screening, assessment, and treatment services, including culturally and linguistically ap- propriate services,
p.000131: as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal
p.000131: depression.
p.000131: (b) APPLICATION.—To seek a grant under this section, a State shall submit an application to the
p.000131: Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a
p.000131: minimum, any such application shall include expla- nations of—
p.000131: (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for
p.000131: mater- nal depression in 1 or more communities; and
p.000131: (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for
p.000131: maternal depression.
p.000131: (c) PRIORITY.—In awarding grants under this section, the Sec- retary may give priority to States proposing to
p.000131: improve or enhance access to screening services for maternal depression in primary care settings.
p.000131: (d) USE OF FUNDS.—The activities eligible for funding through a grant under subsection (a)—
p.000131: (1) shall include—
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: Sec. 317M PUBLIC HEALTH SERVICE ACT 132
p.000131:
p.000131: (A) providing appropriate training to health care pro- viders; and
p.000131: (B) providing information to health care providers, in- cluding information on maternal depression screening,
p.000131: treatment, and followup support services, and linkages to community-based resources; and
p.000131: (2) may include—
p.000131: (A) enabling health care providers (including obstetri- cian-gynecologists, pediatricians, psychiatrists,
p.000131: mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric
p.000131: consultation (in- person or remotely) to aid in the treatment of pregnant and parenting women;
p.000131: (B) establishing linkages with and among community- based resources, including mental health resources, pri- mary
p.000131: care resources, and support groups; and
p.000131: (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in
p.000131: section 330I(a)).
p.000131: (e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $5,000,000
p.000131: for each of fiscal years 2018 through 2022.
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p.000131: January 30, 2020
p.000131: ORAL HEALTH PROMOTION AND DISEASE PREVENTION
p.000131: SEC. 317M. ø247b–14¿ (a) GRANTS TO INCREASE RESOURCES FOR COMMUNITY WATER FLUORIDATION.—
p.000131: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000131: may make grants to States and Indian tribes for the purpose of in- creasing the resources available for community
p.000131: water fluorida- tion.
p.000131: (2) USE OF FUNDS.—A State shall use amounts provided under a grant under paragraph (1)—
p.000131: (A) to purchase fluoridation equipment;
p.000131: (B) to train fluoridation engineers;
p.000131: (C) to develop educational materials on the benefits of fluoridation; or
p.000131: (D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
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p.000243: the United States, alone or in collaboration with American participants, when such transactions may inure to
p.000243: the ben- efit of the American people.
p.000243: (F) ESTABLISHMENT OF RESEARCH CENTERS.—The Sec- retary may assess the feasibility and appropriateness of
p.000243: establishing, through contract, grant, cooperative agree- ment, or other transaction, an arrangement with an
p.000243: exist- ing research center in order to achieve the goals of this section. If such an agreement is not
p.000243: feasible and appro- priate, the Secretary may establish one or more federally- funded research and
p.000243: development centers, or university-af- filiated research centers, in accordance with section 303(c)(3) of
p.000243: the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(3)).
p.000243: (G) GOVERNMENT PURPOSE.—In awarding contracts, grants, and cooperative agreements under this section, the
p.000243: Secretary shall provide a clear statement of defined Gov- ernment purpose related to activities
p.000243: included in sub- section (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
p.000243: (6) AT-RISK INDIVIDUALS.—In carrying out the functions under this section, the Secretary may give priority
p.000243: to the ad- vanced research and development of qualified countermeasures and qualified pandemic or epidemic products
p.000243: that are likely to be safe and effective with respect to children, pregnant women,
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000243: Sec. 319L PUBLIC HEALTH SERVICE ACT 244
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p.000243: older adults, and other at-risk individuals with relevant char- acteristics that warrant consideration during
p.000243: the process of re- searching and developing such countermeasures and products.
p.000243: (7) PERSONNEL AUTHORITIES.—
p.000243: (A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFES- SIONAL PERSONNEL.—
p.000243: (i) IN GENERAL.—In addition to any other per- sonnel authorities, the Secretary may—
p.000243: (I) without regard to those provisions of title 5, United States Code, governing appointments in the
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p.000251: time) during which the member is engaged in the actual performance of duties as a member of the Board.
p.000251: (C) TRAVEL EXPENSES.—Each member of the Board shall receive travel expenses, including per diem in lieu of
p.000251: subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5,
p.000251: United States Code.
p.000251: (D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board with the
p.000251: approval for the contributing agency without reim- bursement, and such detail shall be without
p.000251: interruption or loss of civil service status or privilege.
p.000251: (b) OTHER WORKING GROUPS.—The Secretary may establish a working group of experts, or may use an existing working
p.000251: group or advisory committee, to—
p.000251: (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified
p.000251: pandemic or epidemic product;
p.000251: (2) identify accepted animal models for particular diseases and conditions associated with any biological,
p.000251: chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify
p.000251: strategies to accelerate animal model and research tool development and validation; and
p.000251: (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified
p.000251: counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective
p.000251: with respect to children, pregnant women, and other vulnerable populations, and other issues regarding
p.000251: activities under this section that affect such populations.
p.000251: (c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same
p.000251: meaning in this section as such term is given in section 319L.
p.000251: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $1,000,000 to carry out this
p.000251: section for fiscal year 2007 and each fiscal year thereafter.
p.000251: HANSEN’S DISEASE PROGRAM
p.000251: SEC. 320. ø247e¿ (a)(1) At or through the National Hansen’s Disease Programs Center (located in the
p.000251: State of Louisiana), the Secretary shall without charge provide short-term care and treat- ment, including
p.000251: outpatient care, for Hansen’s disease and related complications to any person determined by the Secretary
p.000251: to be in need of such care and treatment. The Secretary may not at or through such Center provide
p.000251: long-term care for any such disease or complication.
p.000251: (2) The Center referred to in paragraph (1) shall conduct train- ing in the diagnosis and management of Hansen’s
p.000251: disease and re- lated complications, and shall conduct and promote the coordina-
p.000251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000253: PUBLIC HEALTH SERVICE ACT
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p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
p.000263: providing serv- ices to any medically underserved population among which there is a substantial incidence
p.000263: of infant mortality or among which there is a significant increase in the incidence of infant mortality.
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
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p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
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p.000283: regarding epilepsy and seizure.
p.000283: (b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDI-
p.000283: CALLY UNDERSERVED AREAS.—
p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000283: Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access
p.000283: to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others
p.000283: residing in medically underserved areas.
p.000283: (2) APPLICATION FOR GRANT.—A grant may not be awarded under paragraph (1) unless an application therefore is
p.000283: sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted
p.000283: in such form and manner and shall contain such information as the Secretary may prescribe.
p.000283: (c) DEFINITIONS.—For purposes of this section:
p.000283: (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive
p.000283: electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may
p.000283: revise the definition of such term to the extent the Secretary determines necessary.
p.000283: (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6).
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000283: SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
p.000283: (a) INFANT ADOPTION AWARENESS.—
p.000283: (1) IN GENERAL.—The Secretary shall make grants to na- tional, regional, or local adoption organizations for
p.000283: the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers
p.000283: in providing adoption in- formation and referrals to pregnant women on an equal basis with all other
p.000283: courses of action included in nondirective coun- seling to pregnant women.
p.000283: (2) BEST-PRACTICES GUIDELINES.—
p.000283: (A) IN GENERAL.—A condition for the receipt of a grant under paragraph (1) is that the adoption organization
p.000283: in- volved agree that, in providing training under such para- graph, the organization will follow the
p.000283: guidelines devel- oped under subparagraph (B).
p.000283: (B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
p.000283: (i) IN GENERAL.—The Secretary shall establish and supervise a process described in clause (ii) in
p.000283: which the participants are—
p.000283: (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise
p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
p.000285: (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing
p.000285: training for the designated staff of eligible health cen- ters, such organization will make reasonable efforts to
p.000285: ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of
p.000285: the adoption process and are experienced in pro- viding adoption information and referrals in the geo-
p.000285: graphic areas in which the eligible health centers are located, and that the designated staff
p.000285: receive the training in such areas.
p.000285: (B) RULE OF CONSTRUCTION REGARDING TRAINING OF TRAINERS.—With respect to individuals who under a grant under
p.000285: paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subpara-
p.000285: graph as ‘‘trainers’’), subparagraph (A)(iii) may not be con- strued as establishing any limitation regarding the
p.000285: geo- graphic area in which the trainers receive instruction in being such trainers. A trainer may receive such
p.000285: instruction in a different geographic area than the area in which the trainer trains (or will train) the
p.000285: designated staff of eligible health centers.
p.000285:
p.000285:
p.000285:
p.000285: January 30, 2020
p.000285: 35 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000285:
p.000285:
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p.000285: Sec. 330F PUBLIC HEALTH SERVICE ACT 286
p.000285:
p.000285: (4) ADOPTION ORGANIZATIONS; ELIGIBLE HEALTH CENTERS; OTHER DEFINITIONS.—For purposes of this section:
p.000285: (A) The term ‘‘adoption organization’’ means a na- tional, regional, or local organization—
p.000285: (i) among whose primary purposes are adoption;
p.000285: (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa-
p.000285: tion and referrals to pregnant women; and
p.000285: (iii) that is a nonprofit private entity.
p.000285: (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who
p.000285: provide pregnancy or adoption information and referrals (or will provide such information and referrals
p.000285: after receiving training under a grant under paragraph (1)).
p.000285: (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health
p.000285: services to pregnant women.
p.000285: (5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A condition for the receipt of a grant under paragraph (1) is
p.000285: that the adoption organization involved agree to make reasonable efforts to ensure that the eligible
p.000285: health centers with respect to which training under the grant is provided include—
p.000285: (A) eligible health centers that receive grants under section 1001 (relating to voluntary family
p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000285: adoption informa- tion and referral, upon request, are provided by eligible
p.000285:
p.000285:
p.000285:
p.000285: January 30, 2020
p.000285: 36 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000285:
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p.000287: PUBLIC HEALTH SERVICE ACT
p.000287: Sec. 330G
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...

p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
p.000465:
p.000465:
p.000465:
p.000465:
p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000465:
p.000465:
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p.000465:
p.000465: Sec. 379 PUBLIC HEALTH SERVICE ACT 466
p.000465:
p.000465:
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p.000465: January 30, 2020
p.000465:
p.000465: (ii) Educating and providing information to preg- nant women who are willing to donate cord blood units.
p.000465: (iii) Training individuals in requesting pregnant women to serve as cord blood donors.
p.000465: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000465: Pro- gram shall give priority to supporting the recruitment of pregnant women to serve as donors of cord blood
p.000465: for popu- lations that are identified under paragraph (1).
p.000465: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000465: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000465: the public regarding cord blood transplants from donors as a treatment option.
p.000465: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000465: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000465: subsection (d)(2).
p.000465: (h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE MARROW AND CORD BLOOD.—
p.000465: (1) IN GENERAL.—The Secretary shall establish and main- tain, through a contract or other means
p.000465: determined appro- priate by the Secretary, an office of patient advocacy (in this subsection referred to as
p.000465: the ‘‘Office’’).
p.000465: (2) GENERAL FUNCTIONS.—The Office shall meet the fol- lowing requirements:
p.000465: (A) The Office shall be headed by a director.
p.000465: (B) The Office shall be staffed by individuals with ex- pertise in bone marrow and cord blood therapy covered
p.000465: under the Program.
p.000465: (C) The Office shall operate a system for patient advo- cacy, which shall be separate from mechanisms for donor
p.000465: advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to
p.000465: conduct, a search for a bone marrow donor or cord blood unit.
p.000465: (D) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the
...

p.000487:
p.000487:
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p.000487:
p.000487:
p.000487: January 30, 2020
p.000487: (1) provide for an evaluation of the activities for which an award is made under sections 398 or 398A; and
p.000487: (2) not later than 1 year after the completion of such eval- uations, submit to the Congress a report describing
p.000487: the find- ings made as a result of the evaluations.
p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000487:
...

p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
...

p.000489: (5) HOME VISITING SERVICES TEAM.—The team to be con- sulted under paragraph (4) on behalf of a family shall
p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
...

p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
p.000495:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: Sec. 399A PUBLIC HEALTH SERVICE ACT 496
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
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p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
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p.000501: and services for children of substance abusers.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
...

p.000521:
p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.000551: nonprofit organization with chapters, other affiliated organizations, or networks in States throughout
p.000551: the United States with experience serving the popu- lation of individuals with neurological disease
p.000551: and have dem- onstrated experience in neurological disease research, care, and pa- tient services.
p.000551: (k) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000551: $5,000,000 for each of fiscal years 2018 through 2022.
p.000551: SEC. 399T. ø280g–8¿ SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR
p.000551: POSTNATALLY DIAGNOSED CONDITIONS.
p.000551: (a) DEFINITIONS.—In this section:
p.000551: (1) DOWN SYNDROME.—The term ‘‘Down syndrome’’ refers to a chromosomal disorder caused by an error in
p.000551: cell division that results in the presence of an extra whole or partial copy of chromosome 21.
p.000551: (2) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any person or entity required by State or
p.000551: Federal law or regulation to be licensed, registered, or certified to pro- vide health care services, and who is so
p.000551: licensed, registered, or certified.
p.000551: (3) POSTNATALLY DIAGNOSED CONDITION.—The term ‘‘postnatally diagnosed condition’’ means any health
p.000551: condition identified during the 12-month period beginning at birth.
p.000551: (4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘pre- natally diagnosed condition’’ means any fetal health
p.000551: condition identified by prenatal genetic testing or prenatal screening pro- cedures.
p.000551: (5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diag- nostic or screening tests offered to pregnant women
p.000551: seeking routine prenatal care that are administered on a required or recommended basis by a health care
p.000551: provider based on medical history, family background, ethnic background, previous test results, or other risk
p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
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p.000591: eligible hos- pitals.
p.000591: (b) REPORT TO THE SECRETARY.—As determined appropriate by the Secretary, eligible hospitals and patient
p.000591: safety organizations working with those hospitals shall report to the Secretary on the processes employed
p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000637: has applied.
p.000637: DES
p.000637: SEC. 403D. ø283a–3¿ (a) The Director of NIH shall establish a program for the conduct and support of research and
p.000637: training, the dissemination of health information, and other programs with re- spect to the diagnosis and
p.000637: treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred
p.000637: to as ‘‘DES’’).
p.000637: (b) In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private
p.000637: entities representing individ- uals who have been exposed to DES, shall conduct or support pro- grams to educate
p.000637: health professionals and the public on the drug, including the importance of identifying and treating
p.000637: individuals who have been exposed to the drug.
p.000637: (c) After consultation with the Office of Research on Women’s Health, the Director of NIH, acting
p.000637: through the appropriate na- tional research institutes, shall in carrying out subsection (a) con- duct or
p.000637: support one or more longitudinal studies to determine the incidence of the following diseases or
p.000637: disorders in the indicated populations and the relationship of DES to the diseases or dis- orders:
p.000637: (1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant,
p.000637:
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p.000637: January 30, 2020
p.000637: 5 So in law. Paragraph (3) probably should be subsection (b).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000637: Sec. 404A PUBLIC HEALTH SERVICE ACT 638
p.000637:
p.000637: the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of
p.000637: the immune system, including autoimmune disease).
p.000637: (2) In the case of women exposed to DES in utero, the inci- dence of clear cell cancer (including recurrences), the
p.000637: long-term health effects of such cancer, and the effects of treatments for such cancer.
p.000637: (3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders
p.000637: (including im- pairments of the reproductive and autoimmune systems).
p.000637: (4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and
p.000637: disorders.
p.000637: (d) For purposes of this section, an individual shall be consid- ered to have been exposed to DES in utero
p.000637: if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938)
p.000637: administered to the biological mother of the indi- vidual.
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p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000747: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of drug
p.000747: abuse. In carrying out the program, the Director of the Institute shall give special consider- ation to
p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
p.000747:
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p.000747: 40 So in law. See section 16(a)(5) of Public Law 96–180 (93 Stat. 1305). The period probably should be
p.000747: ‘‘; and’’. (Section 464J formerly was section 504 of another law. The amendment made by Public Law 96–180 was directed
p.000747: to section 504 of that other law, which was Public Law 91– 616.)
p.000747: 41 So in law. See section 2(a) of Public Law 102–352 (106 Stat. 938). Section 701(1) does not provide
p.000747: a definition for the term ‘‘construction’’, but former section 701(1) did provide such a definition.
p.000747: Public Law 102–408 amended title VII generally; definitions for the title are now pro- vided in section 799, and that
p.000747: section does not define the term ‘‘construction’’.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000749: PUBLIC HEALTH SERVICE ACT
p.000749: Sec. 464N
p.000749:
p.000749: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Substance Abuse and Mental Health
p.000749: Services Ad- ministration in focusing the services research activities of the Insti- tute and in disseminating the
p.000749: results of such research to health professionals and the general public.
p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
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p.000749: including related biomedical, be- havioral, and social issues.
p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
p.000749: for drug abuse and addiction may be used for research and clinical trials relating to—
p.000749: (A) the effects of drug abuse on the human body, in- cluding the brain;
p.000749: (B) the addictive nature of drugs and how such effects differ with respect to different individuals;
p.000749: (C) the connection between drug abuse and mental health;
p.000749: (D) the identification and evaluation of the most effec- tive methods of prevention of drug abuse and addiction;
p.000749: (E) the identification and development of the most ef- fective methods of treatment of drug addiction,
p.000749: including pharmacological treatments;
p.000749: (F) risk factors for drug abuse;
p.000749: (G) effects of drug abuse and addiction on pregnant women and their fetuses; and
p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
p.000749:
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p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
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p.000847: January 30, 2020
p.000847: 6 Section 4 of Public Law 108–358 (118 Stat. 1664) authorizes the Secretary of Health and Human Services
p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: January 30, 2020
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p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
p.000847: (5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the
p.000847: National Institute on Alcohol Abuse and Alcoholism, and with the States to promote the study, dissemination, and
p.000847: implementation of research find- ings that will improve the delivery and effectiveness of treat- ment
p.000847: services;
p.000847: (6) collaborate with the Administrator of the Health Re- sources and Services Administration and the
p.000847: Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into
p.000847: the mainstream of the health care system of the United States of programs for providing treat- ment
p.000847: services;
p.000847: (7) evaluate plans submitted by the States pursuant to sec- tion 1932(a)(6) in order to determine whether the
p.000847: plans ade- quately provide for the availability, allocation, and effective- ness of treatment services;
p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
p.000847: private entities;
p.000847: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000847: of grantees after such grants are awarded;
p.000847: (14) work with States, providers, and individuals in recov- ery, and their families, to promote the expansion
p.000847: of recovery support services and systems of care oriented toward recovery;
p.000847: (15) in cooperation with the Secretary, implement and dis- seminate, as appropriate, the recommendations in the
p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
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p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
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p.000853: (2) The term ‘‘eligible woman’’ means a woman who has been admitted to a program operated pursuant to
p.000853: subsection (a).
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p.000853: (3) The term ‘‘funding agreement’’, with respect to an award under subsection (a), means that the Director may
p.000853: make the award only if the applicant makes the agreement involved.
p.000853: (4) The term ‘‘treatment services’’ means treatment for a substance use disorder, including the counseling
p.000853: and services described in subsection (c)(2).
p.000853: (5) The term ‘‘supplemental services’’ means the services described in subsection (d).
p.000853: (r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.—
p.000853: (1) IN GENERAL.—From amounts made available under subsection (s), the Director of the Center for
p.000853: Substance Abuse Treatment shall carry out a pilot program under which com- petitive grants are made by
p.000853: the Director to State substance abuse agencies—
p.000853: (A) to enhance flexibility in the use of funds designed to support family-based services for
p.000853: pregnant and postpartum women with a primary diagnosis of a sub- stance use disorder, including opioid use
p.000853: disorders;
p.000853: (B) to help State substance abuse agencies address identified gaps in services furnished to such women
p.000853: along
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000853: Sec. 508 PUBLIC HEALTH SERVICE ACT 854
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p.000853: the continuum of care, including services provided to women in nonresidential-based settings; and
p.000853: (C) to promote a coordinated, effective, and efficient State system managed by State substance abuse
p.000853: agencies by encouraging new approaches and models of service de- livery.
p.000853: (2) REQUIREMENTS.—In carrying out the pilot program under this subsection, the Director shall—
p.000853: (A) require State substance abuse agencies to submit to the Director applications, in such form and manner and
p.000853: containing such information as specified by the Director, to be eligible to receive a grant under the program;
p.000853: (B) identify, based on such submitted applications, State substance abuse agencies that are eligible for
p.000853: such grants;
p.000853: (C) require services proposed to be furnished through such a grant to support family-based treatment and
p.000853: other services for pregnant and postpartum women with a pri- mary diagnosis of a substance use
p.000853: disorder, including opioid use disorders;
p.000853: (D) not require that services furnished through such a grant be provided solely to women that reside in facilities;
p.000853: (E) not require that grant recipients under the pro- gram make available through use of the grant all the serv-
p.000853: ices described in subsection (d); and
p.000853: (F) consider not applying the requirements described in paragraphs (1) and (2) of subsection (f) to an applicant,
p.000853: depending on the circumstances of the applicant.
p.000853: (3) REQUIRED SERVICES.—
p.000853: (A) IN GENERAL.—The Director shall specify a min- imum set of services required to be made available to eligi-
p.000853: ble women through a grant awarded under the pilot pro- gram under this subsection. Such minimum set of
p.000853: serv- ices—
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p.000853: (i) shall include the services requirements de- scribed in subsection (c) and be based on the rec-
p.000853: ommendations submitted under subparagraph (B); and
p.000853: (ii) may be selected from among the services de- scribed in subsection (d) and include other services as
p.000853: appropriate.
p.000853: (B) STAKEHOLDER INPUT.—The Director shall convene and solicit recommendations from stakeholders, including
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p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
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p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: Sec. 760 PUBLIC HEALTH SERVICE ACT 1052
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p.001051: in a community-based setting, followed by a vir- tual rotation in which the resident or fellow con-
p.001051: tinues to support the care of patients at the teach- ing health center or in the community-based set- ting
p.001051: through the use of health information tech- nology and, as appropriate, telehealth services;
p.001051: (II) an in-person training track that includes a rotation, during which the resident or fellow practices
p.001051: at a teaching health center or in a com- munity-based setting; or
p.001051: (III) an in-person training track that includes a rotation during which the resident practices in a
p.001051: community-based setting that specializes in the treatment of infants, children, adolescents, or pregnant
p.001051: or postpartum women; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such training.
p.001051: (2) TRAINING FOR OTHER PROVIDERS.—A recipient of a grant under subsection (a)(2)—
p.001051: (A) shall use the grant funds to plan, develop, or oper- ate a training program to provide mental and substance
p.001051: use disorders services in underserved, community-based settings, as appropriate, that integrate primary care
p.001051: and mental and substance use disorders prevention and treat- ment services; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
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p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
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p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
p.001309: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001309: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001309: adequate level of treatments services for women described in such para-
p.001309:
p.001309: 5 Paragraph (2)(A) of section 3303(f) of Public Law 106–310 (114 Stat. 1211) provides as fol- lows:
p.001309: (2) CONFORMING AMENDMENTS.—Effective upon the publication of the regulations devel- oped in accordance with
p.001309: section 1932(e)(1) of the Public Health Service Act (42 U.S.C. 300x– 32(d))—
p.001309: (A) section 1922(c) of the Public Health Service Act (42 U.S.C. 300x–22(c)) is amended by—
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p.001315: retailers issued under part 1140 of title 21, Code of Federal Regulations.
p.001315: (d) TRANSITIONAL GRANTS.—
p.001315: (1) IN GENERAL.—The Secretary shall award grants under this subsection to each State that receives
p.001315: funding under sec- tion 1921 to ensure compliance of each such State with this section.
p.001315: (2) USE OF FUNDS.—A State receiving a grant under this subsection—
p.001315: (A) shall use amounts received under such grant for activities to plan for or ensure compliance in the
p.001315: State with subsection (a); and
p.001315: (B) in the case of a State for which the Secretary has made a determination under subsection (b) that the State
p.001315: is prepared to meet, or has met, the requirements of sub- section (a), may use such funds for tobacco
p.001315: cessation activi- ties, strategies to prevent the use of tobacco products by individuals under the age of
p.001315: 21, or allowable uses under section 1921.
p.001315: (3) SUPPLEMENT NOT SUPPLANT.—Grants under this sub- section shall be used to supplement and not supplant
p.001315: other Federal, State, and local public funds provided for activities under paragraph (2).
p.001315: (4) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there are authorized to be
p.001315: appropriated
p.001315: $18,580,790 for each of fiscal years 2020 through 2024.
p.001315: (5) SUNSET.—This subsection shall have no force or effect after September 30, 2024.
p.001315: (e) TECHNICAL ASSISTANCE.—The Secretary shall provide tech- nical assistance to States related to the
p.001315: activities required under this section.
p.001315: SEC. 1927. ø300x–27¿ TREATMENT SERVICES FOR PREGNANT WOMEN.
p.001315: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved—
p.001315: (1) will ensure that each pregnant woman in the State who seeks or is referred for and would benefit from such
p.001315: services is given preference in admissions to treatment facilities receiv- ing funds pursuant to the grant; and
p.001315: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: 1317
p.001317: PUBLIC HEALTH SERVICE ACT
p.001317: Sec. 1928
p.001317:
p.001317: (2) will, in carrying out paragraph (1), publicize the avail- ability to such women of services from the
p.001317: facilities and the fact that the women receive such preference.
p.001317: (b) REFERRALS REGARDING STATES.—A funding agreement for a grant under section 1921 is that, in
p.001317: carrying out subsection (a)(1)—
p.001317: (1) the State involved will require that, in the event that a treatment facility has insufficient
p.001317: capacity to provide treat- ment services to any woman described in such subsection who seeks the services from
p.001317: the facility, the facility refer the woman to the State; and
p.001317: (2) the State, in the case of each woman for whom a refer- ral under paragraph (1) is made to the State—
p.001317: (A) will refer the woman to a treatment facility that has the capacity to provide treatment
p.001317: services to the woman; or
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p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001321:
p.001321: Sec. 1932 PUBLIC HEALTH SERVICE ACT 1322
p.001321:
p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
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p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
p.001331: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.001331: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.001331: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.001331: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
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p.001331:
p.001331: Sec. 1948 PUBLIC HEALTH SERVICE ACT 1332
p.001331:
p.001331: whole or in part with funds made available under section 1911 or 1921.
p.001331: (b) ENFORCEMENT.—
p.001331: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
p.001331: State and shall request the chief executive officer to secure compliance. If within a reasonable period of
p.001331: time, not to exceed
p.001331: 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
p.001331: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.001331: insti- tuted;
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p.001331: Department of Health and Human Serv- ices.
p.001331: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.001331: Secretary shall reduce the amount of payments under the program in-
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
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p.001339:
p.001341: 1341
p.001341: PUBLIC HEALTH SERVICE ACT
p.001341: Sec. 2001
p.001341:
p.001341: (1) The term ‘‘interim maintenance services’’ means the provision of methadone in a treatment program under the
p.001341: cir- cumstances described in paragraphs (1) and (2) of subsection (a).
p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
p.001341: (3) The term ‘‘treatment program’’ means a public or non- profit private program of treatment for
p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
p.001341:
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
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p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001341: January 30, 2020
p.001341:
p.001341: and are frequently associated with or are a cause of other trou- blesome situations in the family; and
p.001341: (B) such problems are best approached through a variety of integrated and essential services provided to
p.001341: adolescents and their families by other family members, religious and chari- table organizations, voluntary
...

p.001341: (B) there is limited knowledge concerning which means of intervention are effective in mediating or
p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
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p.001343: January 30, 2020
p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
p.001343: care services in a single setting or the capability of creating a network through which all care services
p.001343: would be provided; or
p.001343: (B) in the case of an organization which will provide prevention services, the capability of providing
p.001343: such serv- ices;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001343: Sec. 2002 PUBLIC HEALTH SERVICE ACT 1344
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p.001343: January 30, 2020
p.001343:
p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
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p.001345: (1) provide to eligible persons—
p.001345: (A) care services;
p.001345: (B) prevention services; or
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p.001345: (C) care and prevention services (in the case of a grantee who is providing a combination of care and
p.001345: pre- vention services);
p.001345: (2) coordinate, integrate, and provide linkages among pro- viders of care, prevention, and other services
p.001345: for eligible per- sons in furtherance of the purposes of this title;
p.001345: (3) provide supplemental services where such services are not adequate or not available to eligible persons in
p.001345: the commu- nity and which are essential to the care of pregnant adoles- cents and to the prevention of
p.001345: adolescent premarital sexual re- lations and adolescent pregnancy;
p.001345: (4) plan for the administration and coordination of preg- nancy prevention services and programs of care
p.001345: for pregnant adolescents and adolescent parents which will further the ob- jectives of this title; and
p.001345: (5) fulfill assurances required for grant approval by section 2006.
p.001345: (b)(1) No funds provided for a demonstration project for serv- ices under this title may be used for
p.001345: the provision of family plan- ning services (other than counseling and referral services) to ado- lescents
p.001345: unless appropriate family planning services are not other- wise available in the community.
p.001345: (2) Any grantee who receives funds for a demonstration project for services under this title and who, after determining
p.001345: under para- graph (1) that appropriate family planning services are not other- wise available in the
p.001345: community, provides family planning services (other than counseling and referral services) to adolescents may
p.001345: only use funds provided under this title for such family planning services if all funds received by such
p.001345: grantee from all other sources to support such family planning services are insufficient to support such family
p.001345: planning services.
p.001345: (c) Grantees who receive funds for a demonstration project for services under this title shall charge fees for
p.001345: services pursuant to a fee schedule approved by the Secretary as a part of the applica- tion described
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p.001345: guardians of the unemancipated minor refuse to make such payments.
p.001345: PRIORITIES, AMOUNTS, AND DURATION OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2005. ø300z–4¿ (a) In approving applications for grants for demonstration projects for services under
p.001345: this title, the Sec- retary shall give priority to applicants who—
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: 1347
p.001347: PUBLIC HEALTH SERVICE ACT
p.001347: Sec. 2005
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p.001347: (1) serve an area where there is a high incidence of adoles- cent pregnancy;
p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
p.001347: geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for
p.001347: pregnant adolescents and adolescent parents in such area.
p.001347: (2) In making grants for demonstration projects for services under this title, the Secretary shall
p.001347: consider the special needs of
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: Sec. 2006 PUBLIC HEALTH SERVICE ACT 1348
p.001347:
p.001347: rural areas and, to the maximum extent practicable, shall dis- tribute funds taking into consideration the
p.001347: relative number of ado- lescents in such areas in need of such services.
p.001347: (c)(1) A grantee may not receive funds for a demonstration project for services under this title for a period
p.001347: in excess of 5 years. (2)(A) Subject to paragraph (3), a grant for a demonstration
p.001347: project for services under this title may not exceed—
p.001347: (i) 70 per centum of the costs of the project for the first and second years of the project;
p.001347: (ii) 60 per centum of such costs for the third year of the project;
p.001347: (iii) 50 per centum of such costs for the fourth year of the project; and
p.001347: (iv) 40 per centum of such costs for the fifth year of the project.
p.001347: (B) Non-Federal contributions required by subparagraph (A) may be in cash or in kind, fairly evaluated, including
p.001347: plant, equip- ment, or services.
p.001347: (3) The Secretary may waive the limitation specified in para- graph (2)(A) for any year in accordance with
p.001347: criteria established by regulation.
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p.001347: January 30, 2020
p.001347: REQUIREMENTS FOR APPLICATIONS
p.001347: SEC. 2006. ø300z–5¿ (a) An application for a grant for a dem- onstration project for services under this
p.001347: title shall be in such form and contain such information as the Secretary may require, and shall include—
p.001347: (1) an identification of the incidence of adolescent preg- nancy and related problems;
p.001347: (2) a description of the economic conditions and income levels in the geographic area to be served;
p.001347: (3) a description of existing pregnancy prevention services and programs of care for pregnant adolescents
p.001347: and adolescent parents (including adoption services), and including where, how, by whom, and to which
p.001347: population groups such services are provided, and the extent to which they are coordinated in the
p.001347: geographic area to be served;
p.001347: (4) a description of the major unmet needs for services for adolescents at risk of initial or recurrent
p.001347: pregnancies and an estimate of the number of adolescents not being served in the area;
p.001347: (5)(A) in the case of an applicant who will provide care services, a description of how all core services
p.001347: will be provided in the demonstration project using funds under this title or will otherwise be provided
p.001347: by the grantee in the area to be served, the population to which such services will be provided, how such
p.001347: services will be coordinated, integrated, and linked with other related programs and services and the
p.001347: source or sources of funding of such core services in the public and pri- vate sectors; or
p.001347: (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be
p.001347: provided and how the applicant will provide such services;
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001349: 1349
p.001349: PUBLIC HEALTH SERVICE ACT
p.001349: Sec. 2006
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p.001349: (ii) to collect reimbursement for health or other serv- ices provided to persons who are entitled to have
p.001349: payment made on their behalf for such services under any Federal or other government program or private
p.001349: insurance pro- gram; and
p.001349: (iii) to seek such reimbursement on the basis of the full amount of fees for services without
p.001349: application of any discount; and
p.001349: (C) assurances that the applicant has submitted or will submit to the Secretary such reports as the Secretary
p.001349: may re- quire to determine compliance with this paragraph;
p.001349: (17) assurances that the applicant will make maximum use of funds available under title X of this Act;
p.001349: (18) assurances that the acceptance by any individual of family planning services or family planning
p.001349: information (in- cluding educational materials) provided through financial as- sistance under this title
p.001349: shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service fur-
p.001349: nished by the applicant;
p.001349: (19) assurances that fees collected by the applicant for services rendered in accordance with this title shall
p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: 1351
p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
p.001351: (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents
p.001351: or guardians of any unemancipated minor requesting services from the applicant and, except as provided in
p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001351: (ii) in the case of a pregnant unemancipated minor re- questing services from the applicant, the applicant will no-
p.001351: tify the parents or guardians of such minor under clause
p.001351: (i) within a reasonable period of time;
p.001351: (B) assurances that the applicant will not notify or request the permission of the parents or
p.001351: guardian of any unemancipated minor without the consent of the minor—
p.001351: (i) who solely is requesting from the applicant preg- nancy testing or testing or treatment for venereal
p.001351: disease;
p.001351: (ii) who is the victim of incest involving a parent; or
p.001351: (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor
p.001351: by blood certifies to the grantee that notification of the parents or guardians of such minor would result in
p.001351: physical injury to such minor; and
p.001351: (C) assurances that the applicant will not require, with re- spect to the provision of services, the permission of the
p.001351: parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to
p.001351: compel such minor to have an abortion;
p.001351: (23) assurances that primary emphasis for services sup- ported under this title shall be given to
p.001351: adolescents seventeen and under who are not able to obtain needed assistance through other means;
p.001351: (24) assurances that funds received under this title shall supplement and not supplant funds received
p.001351: from any other Federal, State, or local program or any private sources of funds; and
p.001351: (25) a plan for the conduct of, and assurances that the ap- plicant will conduct, evaluations of the
p.001351: effectiveness of the services supported under this title in accordance with sub- section (b).
p.001351: (b)(1) Each grantee which receives funds for a demonstration project for services under this title shall expend
p.001351: at least 1 per cen- tum but not in excess of 5 per centum of the amounts received under this title for
p.001351: the conduct of evaluations of the services sup- ported under this title. The Secretary may, for a particular
p.001351: grantee upon good cause shown, waive the provisions of the preceding sen- tence with respect to the amounts to
p.001351: be expended on evaluations, but may not waive the requirement that such evaluations be con- ducted.
p.001351: (2) Evaluations required by paragraph (1) shall be conducted by an organization or entity which is
p.001351: independent of the grantee providing services supported under this title. To assist in con- ducting the
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p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: viding monitoring and evaluation of services supported under this title unless no college or university in the
p.001351: grantee’s State is willing or has the capacity to provide or assist in providing such moni- toring and
p.001351: assistance.
p.001351: (3) The Secretary may provide technical assistance with re- spect to the conduct of evaluations required
p.001351: under this subsection to any grantee which is unable to develop a working relationship with a college or
p.001351: university in the applicant’s State for the reasons described in paragraph (2).
p.001351: (c) Each grantee which receives funds for a demonstration project for services under this title shall
p.001351: make such reports con- cerning its use of Federal funds as the Secretary may require. Re- ports shall include, at
p.001351: such times as are considered appropriate by the Secretary, the results of the evaluations of the services
p.001351: sup- ported under this title.
p.001351: (d)(1) A grantee shall periodically notify the Secretary of the exact number of instances in which a
p.001351: grantee does not notify the parents or guardians of a pregnant unemancipated minor under subsection
p.001351: (a)(22)(B)(iii).
p.001351: (2) For purposes of subsection (a)(22)(B)(iii), the term ‘‘adult’’ means an adult as defined by State law.
p.001351: (e) Each applicant shall provide the Governor of the State in which the applicant is located a copy of each
p.001351: application submitted to the Secretary for a grant for a demonstration project for services under this title. The
p.001351: Governor shall submit to the applicant com- ments on any such application within the period of sixty
p.001351: days be- ginning on the day when the Governor receives such copy. The ap- plicant shall include the comments of
p.001351: the Governor with such ap- plication.
p.001351: (f) No application submitted for a grant for a demonstration project for care services under this title
p.001351: may be approved unless the Secretary is satisfied that core services shall be available through the
p.001351: applicant within a reasonable time after such grant is received.
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p.001351: COORDINATION OF FEDERAL AND STATE PROGRAMS
p.001351: SEC. 2007. ø300z–6¿ (a) The Secretary shall coordinate Federal policies and programs providing services relating to the
p.001351: prevention of adolescent sexual relations and initial and recurrent adolescent pregnancies and providing
p.001351: care services for pregnant adolescents. In achieving such coordination, the Secretary shall—
p.001351: (1) require grantees who receive funds for demonstration projects for services under this title to report
p.001351: periodically to the Secretary concerning Federal, State, and local policies and pro- grams that interfere with the
p.001351: delivery of and coordination of pregnancy prevention services and other programs of care for pregnant
p.001351: adolescents and adolescent parents;
p.001351: (2) provide technical assistance to facilitate coordination by State and local recipients of Federal assistance;
p.001351: (3) review all programs administered by the Department of Health and Human Services which provide prevention services
p.001351: or care services to determine if the policies of such programs are consistent with the policies of this
p.001351: title, consult with other
p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001353: PUBLIC HEALTH SERVICE ACT
p.001353: Sec. 2008
p.001353:
p.001353: departments and agencies of the Federal Government who ad- minister programs that provide such services, and
p.001353: encourage such other departments and agencies to make recommenda- tions, as appropriate, for legislation to
p.001353: modify such programs in order to facilitate the use of all Government programs which provide such services as a
p.001353: basis for delivery of more com- prehensive prevention services and more comprehensive pro- grams of care for
p.001353: pregnant adolescents and adolescent parents;
p.001353: (4) give priority in the provision of funds, where appro- priate, to applicants using single or coordinated
p.001353: grant applica- tions for multiple programs; and
p.001353: (5) give priority, where appropriate, to the provision of funds under Federal programs administered by
p.001353: the Secretary (other than the program established by this title) to projects providing comprehensive
p.001353: prevention services and comprehen- sive programs of care for pregnant adolescents and adolescent parents.
p.001353: (b) Any recipient of a grant for a demonstration project for services under this title shall coordinate
p.001353: its activities with any other recipient of such a grant which is located in the same local- ity.
p.001353: RESEARCH
p.001353: SEC. 2008. ø300z–7¿ (a)(1) The Secretary may make grants and enter into contracts with public agencies
p.001353: or private organiza- tions or institutions of higher education to support the research and dissemination
p.001353: activities described in paragraphs (4), (5), and
p.001353: (6) of section 2001(b).
p.001353: (2) The Secretary may make grants or enter into contracts under this section for a period of one year.
p.001353: A grant or contract under this section for a project may be renewed for four additional one-year periods, which
p.001353: need not be consecutive.
p.001353: (3) A grant or contract for any one-year period under this sec- tion may not exceed $100,000 for the direct costs of
p.001353: conducting re- search or disemination 1 activities under this section and may in- clude such additional
p.001353: amounts for the indirect costs of conducting such activities as the Secretary determines appropriate. The
p.001353: Sec- retary may waive the preceding sentence with respect to a specific project if he determines that—
p.001353: (A) exceptional circumstances warrant such waiver and that the project will have national impact; or
p.001353: (B) additional amounts are necessary for the direct costs of conducting limited demonstration projects for the
p.001353: provision of necessary services in order to provide data for research carried out under this title.
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p.001355: carry out the provi- sions of this title shall report directly to the Assistant Secretary for Health with respect to
p.001355: the activities of such officer or employee in carrying out such provisions.
p.001355: AUTHORIZATION OF APPROPRIATIONS
p.001355: SEC. 2010. ø300z–9¿ (a) For the purpose of carrying out this title, there are authorized to be
p.001355: appropriated $30,000,000 for the fiscal year ending September 30, 1982, $30,000,000 for the fiscal year
p.001355: ending September 30, 1983, $30,000,000 for the fiscal year ending September 30, 1984, and $30,000,000 for
p.001355: the fiscal year ending September 30, 1985.
p.001355: (b) At least two-thirds of the amounts appropriated to carry out this title shall be used to make
p.001355: grants for demonstration projects for services.
p.001355: (c) Not more than one-third of the amounts specified under subsection (b) for use for grants for demonstration
p.001355: projects for serv- ices shall be used for grants for demonstration projects for preven- tion services.
p.001355:
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p.001355:
p.001355: January 30, 2020
p.001355: RESTRICTIONS
p.001355: SEC. 2011. ø300z–10¿ (a) Grants or payments may be made only to programs or projects which do not
p.001355: provide abortions or abortion counseling or referral, or which do not subcontract with or make any payment to any
p.001355: person who provides abortions or abor- tion counseling or referral, except that any such program or project may
p.001355: provide referral for abortion counseling to a pregnant adoles- cent if such adolescent and the parents or
p.001355: guardians of such adoles- cent request such referral; and grants may be made only to projects
p.001355: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001355:
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p.001355:
p.001355: Sec. 2101 PUBLIC HEALTH SERVICE ACT 1356
p.001355: or programs which do not advocate, promote, or encourage abor- tion.
p.001355: (b) The Secretary shall ascertain whether programs or projects comply with subsection (a) and take appropriate action
p.001355: if programs or projects do not comply with such subsection, including with- holding of funds.
p.001355: TITLE XXI—VACCINES
p.001355: Subtitle 1—National Vaccine Program
p.001355: ESTABLISHMENT
p.001355: SEC. 2101. ø300aa–1¿ The Secretary shall establish in the De- partment of Health and Human Services a National
p.001355: Vaccine Pro- gram to achieve optimal prevention of human infectious diseases through immunization and to
p.001355: achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a
p.001355: Director selected by the Secretary.
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p.001359: related injury or death, the person who brought such action may file a petition under subsection (b)
p.001359: for such injury or death.
p.001359: (9) This subsection applies only to a person who has sus- tained a vaccine-related injury or death and
p.001359: who is qualified to file a petition for compensation under the Program.
p.001359: (10) The Clerk of the United States Claims Court is au- thorized to continue to receive, and forward,
p.001359: petitions for com- pensation for a vaccine-related injury or death associated with the administration of a vaccine on
p.001359: or after October 1, 1992.
p.001359: (b) PETITIONERS.—
p.001359: (1)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal
p.001359: represent- ative of such person if such person is a minor or is disabled, or the legal representative of
p.001359: any person who died as the result of the administration of a vaccine set forth in the Vaccine In- jury
p.001359: Table may, if the person meets the requirements of sub- section (c)(1), file a petition for compensation
p.001359: under the Pro- gram.
p.001359: (B) No person may file a petition for a vaccine-related in- jury or death associated with a vaccine
p.001359: administered before the effective date of this part if compensation has been paid under this subtitle for 3500
p.001359: petitions for such injuries or deaths.
p.001359: (2) Only one petition may be filed with respect to each ad- ministration of a vaccine. A covered vaccine administered
p.001359: to a pregnant woman shall constitute more than one administra- tion, one to the mother and one to each child (as
p.001359: such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.
p.001359:
p.001359:
p.001359:
p.001359: January 30, 2020
p.001359: 3 So in law. Probably should be followed by a comma.
p.001359: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001359:
p.001359:
p.001359:
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p.001359:
p.001359:
p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
p.001361:
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p.001361: January 30, 2020
p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
...

p.001361: vaccine-related injury or death,
p.001361: (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records
p.001361: (including all physicians’ and nurses’ notes and test results), vaccination records associated with the
p.001361: vaccine allegedly causing the in- jury, pre- and post-injury physician or clinic records (including all relevant
p.001361: growth charts and test results), all post-injury in- patient and outpatient records (including all
p.001361: provider notes, test results, and medication records), if applicable, a death cer- tificate, and if applicable,
p.001361: autopsy results, and
p.001361: (3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the
p.001361: petitioner and the reasons for their unavailability.
p.001361: (d) ADDITIONAL INFORMATION.—A petition may also include other available relevant medical records relating to the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
p.001361: (e) SCHEDULE.—The petitioner shall submit in accordance with a schedule set by the special master assigned to the
p.001361: petition assess- ments, evaluations, and prognoses and such other records and doc- uments as are reasonably
p.001361: necessary for the determination of the amount of compensation to be paid to, or on behalf of, the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
p.001361: (f) MATERNAL IMMUNIZATION.—
p.001361: (1) IN GENERAL.—Notwithstanding any other provision of law, for purposes of this subtitle, both a woman
p.001361: who received a covered vaccine while pregnant and any child who was in utero at the time such woman
p.001361: received the vaccine shall be considered persons to whom the covered vaccine was adminis- tered and persons
p.001361: who received the covered vaccine.
p.001361: (2) DEFINITION.—As used in this subsection, the term ‘‘child’’ shall have the meaning given that term by
p.001361: subsections
p.001361: (a) and (b) of section 8 of title 1, United States Code, except that, for purposes of this subsection, such
p.001361: section 8 shall be ap- plied as if the term ‘‘include’’ in subsection (a) of such section were replaced with
p.001361: the term ‘‘mean’’.
p.001361:
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p.001361:
p.001361:
p.001361: January 30, 2020
p.001361:
p.001361: JURISDICTION
p.001361: SEC. 2112. ø300aa–12¿ (a) GENERAL RULE.—The United States Claims Court and the United States Claims Court special
p.001361: masters shall, in accordance with this section, have jurisdiction over pro- ceedings to determine if a
p.001361: petitioner under section 2111 is entitled to compensation under the Program and the amount of such com-
p.001361: pensation. The United States Claims Court may issue and enforce such orders as the court deems necessary
p.001361: to assure the prompt payment of any compensation awarded.
p.001361: (b) PARTIES.—
p.001361: (1) In all proceedings brought by the filing of a petition under section 2111(b), the Secretary shall be
p.001361: named as the re-
p.001361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
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p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
p.001371:
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p.001371:
p.001371: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1372
p.001371:
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (2) VACCINES RECOMMENDED AFTER AUGUST 1, 1993.—When after August 1, 1993, the Centers for Disease Control and Pre-
p.001371: vention recommends a vaccine to the Secretary for routine ad- ministration to children, the Secretary shall, within 2
p.001371: years of such recommendation, amend the Vaccine Injury Table in- cluded in subsection (a) to include—
p.001371: (A) vaccines which were recommended for routine ad- ministration to children,
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (3) VACCINES RECOMMENDED FOR USE IN PREGNANT WOMEN.—The Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines
p.001371: recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and
p.001371: the information described in subpara- graphs (B) and (C) of paragraph (2) with respect to such vac- cines.
p.001371: COMPENSATION
p.001371: SEC. 2115. ø300aa–15¿ (a) GENERAL RULE.—Compensation awarded under the Program to a petitioner under section
p.001371: 2111 for a vaccine-related injury or death associated with the administra- tion of a vaccine after the
p.001371: effective date of this part 8 shall include the following:
p.001371: (1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and
p.001371: reasonable projected unreimbursable expenses which—
p.001371: (i) result from the vaccine-related injury for which the petitioner seeks compensation,
p.001371: (ii) have been or will be incurred by or on behalf of the person who suffered such injury, and
p.001371: (iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be
p.001371: reasonably nec- essary, or
p.001371: (II) have been or will be for rehabilitation, develop- mental evaluation, special education, vocational
p.001371: training and placement, case management services, counseling, emotional or behavioral therapy,
p.001371: residential and custodial care and service expenses, special equipment, related trav- el expenses, and facilities
p.001371: determined to be reasonably nec- essary.
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 8 Effective October 1, 1988.
p.001371:
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
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p.001501:
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p.001501:
p.001501: Sec. 2625 PUBLIC HEALTH SERVICE ACT 1502
p.001501: Subpart II—Provisions Concerning Pregnancy and Perinatal Transmission of HIV
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p.001501: January 30, 2020
p.001501:
p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
...

p.001503: Nothing in this subpart shall be construed to disqualify a State from receiving grants under this title if such State
p.001503: has established at any time prior to or after the date of enactment of this subpart a program of mandatory HIV testing.
p.001503: SEC. 2628. ø300ff–37a¿ RECOMMENDATIONS FOR REDUCING INCIDENCE OF PERINATAL TRANSMISSION.
p.001503: (a) STUDY BY INSTITUTE OF MEDICINE.—
p.001503: (1) IN GENERAL.—The Secretary shall request the Institute of Medicine to enter into an agreement with the
p.001503: Secretary
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001503:
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p.001503:
p.001503: Sec. 2631 PUBLIC HEALTH SERVICE ACT 1504
p.001503: under which such Institute conducts a study to provide the fol- lowing:
p.001503: (A) For the most recent fiscal year for which the infor- mation is available, a determination of the number of new-
p.001503: born infants with HIV born in the United States with re- spect to whom the attending obstetrician for the
p.001503: birth did not know the HIV status of the mother.
p.001503: (B) A determination for each State of any barriers, in- cluding legal barriers, that prevent or discourage an obste-
p.001503: trician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn
p.001503: infants for HIV/AIDS in circumstances in which the obste- trician does not know the HIV status of the mother of the
p.001503: infant.
p.001503: (C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, in-
p.001503: cluding recommendations on removing the barriers identi- fied under subparagraph (B).
p.001503: If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another
p.001503: appropriate public or nonprofit private entity to conduct the study.
p.001503: (2) REPORT.—The Secretary shall ensure that, not later than 18 months after the effective date of this
p.001503: section, the study required in paragraph (1) is completed and a report de- scribing the findings made in the
p.001503: study is submitted to the ap- propriate committees of the Congress, the Secretary, and the chief public health
p.001503: official of each of the States.
p.001503: (b) PROGRESS TOWARD RECOMMENDATIONS.—In fiscal year 2004, the Secretary shall collect information
p.001503: from the States de- scribing the actions taken by the States toward meeting the rec- ommendations
p.001503: specified for the States under subsection (a)(1)(C).
p.001503: (c) SUBMISSION OF REPORTS TO CONGRESS.—The Secretary shall submit to the appropriate committees of the
p.001503: Congress reports describing the information collected under subsection (b).
p.001503:
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p.001507: January 30, 2020
p.001507:
p.001507: tem, and tests to provide information on appropriate therapeutic measures for preventing and treating the
p.001507: dete- rioration of the immune system and for preventing and treating conditions arising from HIV/AIDS;
p.001507: (C) referrals described in paragraph (2);
p.001507: (D) other clinical and diagnostic services regarding HIV/AIDS, and periodic medical evaluations of individuals
p.001507: with HIV/AIDS; and
p.001507: (E) providing the therapeutic measures described in subparagraph (B).
p.001507: (2) REFERRALS.—The services referred to in paragraph (1)(C) are referrals of individuals with
p.001507: HIV/AIDS to appro- priate providers of health and support services, including, as appropriate—
p.001507: (A) to entities receiving amounts under part A or B for the provision of such services;
p.001507: (B) to biomedical research facilities of institutions of higher education that offer experimental treatment
p.001507: for such disease, or to community-based organizations or other entities that provide such treatment; or
p.001507: (C) to grantees under section 2671, in the case of a pregnant woman.
p.001507: (3) REQUIREMENT OF AVAILABILITY OF ALL EARLY INTERVEN- TION SERVICES THROUGH EACH GRANTEE.—
p.001507: (A) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the applicant for
p.001507: the grant agrees that each of the early intervention services specified in paragraph (2) will be
p.001507: available through the grantee. With respect to compliance with such agreement, such a grantee may expend the grant to
p.001507: provide the early intervention services directly, and may expend the grant to enter into agreements with public or
p.001507: nonprofit private en- tities, or private for-profit entities if such entities are the only available
p.001507: provider of quality HIV care in the area, under which the entities provide the services.
p.001507: (B) OTHER REQUIREMENTS.—Grantees described in—
p.001507: (i) subparagraphs (A), (D), (E), and (F) of section 2652(a)(1) shall use not less than 50 percent of
p.001507: the amount of such a grant to provide the services de- scribed in subparagraphs (A), (B), (D), and (E) of
p.001507: para- graph (1) directly and on-site or at sites where other primary care services are rendered; and
p.001507: (ii) subparagraphs (B) and (C) of section 2652(a)(1) shall ensure the availability of early intervention serv- ices
p.001507: through a system of linkages to community-based primary care providers, and to establish mechanisms for the
p.001507: referrals described in paragraph (1)(C), and for follow-up concerning such referrals.
p.001507: SEC. 2652. ø300ff–52¿ MINIMUM QUALIFICATIONS OF GRANTEES.
p.001507: (a) ELIGIBLE ENTITIES.—
p.001507: (1) IN GENERAL.—The entities referred to in section 2651(a) are public entities and nonprofit private entities that
p.001507: are—
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p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
p.001551: surance issuer offering health insurance coverage in connection with a group health plan, shall not request,
p.001551: require, or pur- chase genetic information with respect to any individual prior to such individual’s
p.001551: enrollment under the plan or coverage in connection with such enrollment.
p.001551: (3) INCIDENTAL COLLECTION.—If a group health plan, or a health insurance issuer offering health insurance
p.001551: coverage in connection with a group health plan, obtains genetic informa- tion incidental to the
p.001551: requesting, requiring, or purchasing of other information concerning any individual, such request, re-
p.001551: quirement, or purchase shall not be considered a violation of paragraph (2) if such request, requirement, or
p.001551: purchase is not in violation of paragraph (1).
p.001551: (e) APPLICATION TO ALL PLANS.—The provisions of subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1) and
p.001551: section 2704 with respect to genetic information, shall apply to group health plans and health insurance
p.001551: issuers without regard to section 2735(a).
p.001551: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001551: individual or family member of an individual shall—
p.001551: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001551: infor- mation of any fetus carried by such pregnant woman; and
p.001551: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001551: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001551: (j) 5 PROGRAMS OF HEALTH PROMOTION OR DISEASE PREVEN-
p.001551: TION.—
p.001551: (1) GENERAL PROVISIONS.—
p.001551: (A) GENERAL RULE.—For purposes of subsection (b)(2)(B), a program of health promotion or disease preven-
p.001551: tion (referred to in this subsection as a ‘‘wellness pro- gram’’) shall be a program offered by an
p.001551: employer that is designed to promote health or prevent disease that meets the applicable requirements of this
p.001551: subsection.
p.001551: (B) NO CONDITIONS BASED ON HEALTH STATUS FAC- TOR.—If none of the conditions for obtaining a
p.001551: premium discount or rebate or other reward for participation in a wellness program is based on an
p.001551: individual satisfying a standard that is related to a health status factor, such wellness program shall not
p.001551: violate this section if participa- tion in the program is made available to all similarly situ- ated individuals and
p.001551: the requirements of paragraph (2) are complied with.
p.001551: (C) CONDITIONS BASED ON HEALTH STATUS FACTOR.—If any of the conditions for obtaining a premium discount or
p.001551:
p.001551:
p.001551:
p.001551: January 30, 2020
p.001551: 5 So in law. There are no subsections (g)–(i).
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001551:
p.001551:
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p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
p.001609: information concerning any indi- vidual, such request, requirement, or purchase shall not be considered a
p.001609: violation of paragraph (2) if such request, require- ment, or purchase is not in violation of paragraph (1).
p.001609: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001609: individual or family member of an individual shall—
p.001609: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001609: infor- mation of any fetus carried by such pregnant woman; and
p.001609: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001609: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001609:
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p.001609:
p.001609: Sec. 2761 PUBLIC HEALTH SERVICE ACT 1610
p.001609:
p.001609: Subpart 3—General Provisions 25
p.001609: SEC. 2761. ø300gg–61¿ ENFORCEMENT.
p.001609: (a) STATE ENFORCEMENT.—
p.001609: (1) STATE AUTHORITY.—Subject to section 2762, each State may require that health insurance issuers that issue,
p.001609: sell, renew, or offer health insurance coverage in the State in the individual market meet the
p.001609: requirements established under this part with respect to such issuers.
p.001609: (2) FAILURE TO IMPLEMENT REQUIREMENTS.—In the case of a State that fails to substantially enforce the requirements
p.001609: set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the
p.001609: requirements of this part under subsection (b) insofar as they relate to the issuance, sale, renewal, and offering of
p.001609: health insurance coverage in the individual market in such State.
...

p.001623: (D) Rapid distribution and administration of medical countermeasures.
p.001623: (E) Effective utilization of any available public and private mobile medical assets (which may include
p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
p.001623: State, local, and tribal operations in the event of a public health emergency.
p.001623: (7) COUNTERMEASURES.—
p.001623: (A) Promoting strategic initiatives to advance counter- measures to diagnose, mitigate, prevent, or treat harm
p.001623: from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally
p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
p.001623: section 319F–3, and ‘‘security countermeasures’’ under section 319F–2.
...

p.001645: described in sec- tion 2802(b)(4)(B);
p.001645: (6) oversee curriculum development for the public health and medical response training program on medical
p.001645: manage- ment of casualties, as it concerns at-risk individuals as de- scribed in subparagraphs (A) through (C)
p.001645: of section 319F(a)(2);
p.001645: (7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk
p.001645: individuals before, during, and following public health emergencies in as timely a manner as is practicable,
p.001645: including from the time a public health threat is identified;
p.001645: (8) ensure that public health and medical information dis- tributed by the Department of Health and Human
p.001645: Services during a public health emergency is delivered in a manner that takes into account the range of communication
p.001645: needs of the in- tended recipients, including at-risk individuals; and
p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
p.001645:
p.001645:
p.001645:
p.001645:
...

Health / Terminally Ill

Searching for indicator terminal:

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p.000293: ensure that—
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p.000293: January 30, 2020
p.000293: (A) not less than 50 percent of the funds awarded shall be awarded for projects in rural areas; and
p.000293: (B) the total amount of funds awarded for such projects for that fiscal year shall be not less than the
p.000293: total amount of funds awarded for such projects for fiscal year 2001 under section 330A (as in effect on the
p.000293: day before the date of enactment of the Health Care Safety Net Amend- ments of 2002).
p.000293: (k) USE OF FUNDS.—
p.000293: (1) TELEHEALTH NETWORK PROGRAM.—The recipient of a grant under subsection (d)(1) may use funds received
p.000293: through such grant for salaries, equipment, and operating or other costs, including the cost of—
p.000293: (A) developing and delivering clinical telehealth serv- ices that enhance access to community-based health
p.000293: care services in rural areas, frontier communities, or medically underserved areas, or for medically
p.000293: underserved popu- lations;
p.000293: (B) developing and acquiring, through lease or pur- chase, computer hardware and software, audio and
p.000293: video equipment, computer network equipment, interactive equipment, data terminal equipment, and other
p.000293: equipment that furthers the objectives of the telehealth network grant program;
p.000293: (C)(i) developing and providing distance education, in a manner that enhances access to care in rural areas,
p.000293: fron-
p.000293: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000295: 295
p.000295: PUBLIC HEALTH SERVICE ACT
p.000295: Sec. 330I
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p.000295: January 30, 2020
p.000295: tier communities, or medically underserved areas, or for medically underserved populations; or
p.000295: (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro-
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Health / addiction

Searching for indicator addicts:

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p.000017: Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific
p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 304 PUBLIC HEALTH SERVICE ACT 78
p.000017:
p.000017: experience in the care, treatment, and rehabilitation of narcotic ad- dicts to the end that each State may be
p.000017: encouraged to provide ade- quate facilities and methods for the care and treatment of its nar- cotic addicts.
p.000017: GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND DEMONSTRATIONS IN HEALTH STATISTICS, HEALTH
p.000017: SERVICES, AND HEALTH CARE TECHNOLOGY ASSESSMENT
p.000017: SEC. 304. 1 ø242b¿ (a) The Secretary may, through the Agency for Health Care Policy and Research or the
p.000017: National Center for Health Statistics or using National Research Service Awards or other appropriate
p.000017: authorities, undertake and support training pro- grams to provide for an expanded and continuing supply of individ-
p.000017: uals qualified to perform the research, evaluation, and demonstra- tion projects set forth in section 306 and in title
p.000017: IX.
p.000017: (b) To implement subsection (a) and section 306, the Secretary may, in addition to any other authority which
p.000017: under other provi- sions of this Act or any other law may be used by him to imple- ment such
p.000017: subsection, do the following:
p.000017: (1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health
p.000017: and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize
p.000017: the physical resources of such Department, provide technical assistance and advice, make grants to
p.000017: public and nonprofit private entities and indi- viduals, and, when appropriate, enter into contracts with pub-
p.000017: lic and private entities and individuals.
p.000017: (2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and
p.000017: treat- ment at such facilities.
...

p.001331: Department of Health and Human Serv- ices.
p.001331: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.001331: Secretary shall reduce the amount of payments under the program in-
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
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p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
...

Health / alcoholism

Searching for indicator alcoholic:

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p.000745:
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p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
p.000745:
p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
...

p.000841: C:\XML\PHSA.BEL HOUSEP
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p.000841: Sec. 503 PUBLIC HEALTH SERVICE ACT 842
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p.000841: January 30, 2020
p.000841:
p.000841: as it may require to carry out its functions. The Assistant Sec- retary or Director shall provide
p.000841: orientation and training for new members of the advisory council to provide for their effective par-
p.000841: ticipation in the functions of the advisory council.
p.000841: REPORTS ON ALCOHOLISM, ALCOHOL ABUSE, AND DRUG ABUSE
p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
...

p.000863: January 30, 2020
p.000863:
p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
...

p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000865:
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p.000867: 867
p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
...

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p.001307:
p.001307:
p.001309: 1309
p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
...

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p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 209 PUBLIC HEALTH SERVICE ACT 12
p.000001:
p.000001: amount of the minimum annual salary rate of the classification grade of the employee.
p.000001: (e) Any civilian employee of the Service who is employed at the Gillis W. Long Hansen’s Disease Center on the
p.000001: date of the enact- ment of the Consolidated Omnibus Budget Reconciliation Act of 1985 shall be entitled
p.000001: to receive, in addition to any compensation to which the employee may otherwise be entitled and for so
p.000001: long as the employee remains employed at the Center, an amount equal to one-fourth of such compensation.
p.000001: (f) Individuals appointed under subsection (g) shall have in- cluded in their fellowships such stipends
p.000001: or allowances, including travel and subsistence expenses, as the Surgeon General may deem necessary to procure
p.000001: qualified fellows.
p.000001: (g) The Secretary is authorized to establish and fix the com- pensation for, within the Public Health
p.000001: Service, not more than one hundred and seventy-nine positions, of which not less than one hundred and fifteen
p.000001: shall be for the National Institutes of Health, not less than five shall be for the National Institute on
p.000001: Alcohol Abuse and Alcoholism for individuals engaged in research on alco- hol and alcoholism, not less than ten shall
p.000001: be for the National Cen- ter for Health Services Research, not less than twelve shall be for the National
p.000001: Center for Health Statistics, and not less than seven shall be for the National Center for Health Care
p.000001: Technology, in the professional, scientific, and executive service, each such position being established to
p.000001: effectuate those research and development ac- tivities of the Public Health Service which require the services
p.000001: of specially qualified scientific, professional, and administrative per- sonnel: Provided, That the rates
p.000001: of compensation for positions es- tablished pursuant to the provisions of this subsection shall not be less than
p.000001: the minimum rate of grade 16 of the General Schedule of the Classification Act of 1949, as amended, 5
p.000001: nor more than (1) the highest rate of grade 18 of the General Schedule of such Act, or (2) in the
p.000001: case of two such positions, the rate specified, at the time the service in the position is performed, for
p.000001: level II of the Ex- ecutive Schedule (5 U.S.C. 5313); and such rates of compensation for all positions
p.000001: included in this proviso shall be subject to the ap- proval of the Civil Service Commission. Positions created pursuant
p.000001: to this subsection shall be included in the classified civil service of the United States, but appointments to
p.000001: such positions shall be made without competitive examination upon approval of the pro- posed appointee’s
p.000001: qualifications by the Civil Service Commission or such officers or agents as it may designate for this purpose.
p.000001:
p.000001: PROFESSIONAL CATEGORIES
...

p.000001: Immigration and Naturaliza- tion Service unless such persons are entitled to care and treatment under section 322(a).
p.000017: 17
p.000017: MONEY COLLECTED FOR CARE OF PATIENTS
p.000017: SEC. 233. ø238b¿ Money collected as provided by law for ex- penses incurred in the care and treatment
p.000017: of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts
p.000017: received from any executive department on ac- count of care and treatment of pay patients, shall be
p.000017: covered into the appropriation from which the expenses of such care and treat- ment were paid.
p.000017: TRANSPORTATION OF REMAINS OF OFFICERS
p.000017: SEC. 234. ø238c¿ Appropriations available for traveling ex- penses of the Service shall be available for
p.000017: meeting the cost of preparation for burial and of transportation to the place of burial of remains of
p.000017: commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations
p.000017: available for carrying out the provisions of this Act shall also be available for the payment of such
p.000017: expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may
p.000017: be authorized under other provisions of law.
p.000017: GRANTS TO FEDERAL INSTITUTIONS
p.000017: SEC. 235. ø238d¿ Appropriations to the Public Health Service available under this Act for research,
p.000017: training, or demonstration project grants or for grants to expand existing treatment and re- search
p.000017: programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations
p.000017: under title VI of the Mental Health Systems Act shall also be available, on the same terms and conditions as
p.000017: apply to non-Federal institutions, for grants for the same purpose to Federal institutions, except that grants
p.000017: to such Federal institutions may be funded at 100 per cen- tum of the costs.
p.000017: TRANSFER OF FUNDS
p.000017: SEC. 236. ø238e¿ For the purpose of any reorganization under section 202, the Secretary, with the approval of the
p.000017: Director of the Bureau of the Budget, 18 is authorized to make such transfers of funds between
p.000017: appropriations as may be necessary for the continu- ance of transferred functions.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
...

p.000523: (c) DISSEMINATION OF CRITERIA.—In carrying out this section, the Secretary shall develop a procedure for
p.000523: disseminating the Fetal Alcohol Syndrome and Fetal Alcohol Effect diagnostic criteria de- veloped pursuant to
p.000523: section 705 of the ADAMHA Reorganization Act (42 U.S.C. 485n note) to health care providers, educators, social
p.000523: workers, child welfare workers, and other individuals.
p.000523: (d) NATIONAL TASK FORCE.—
p.000523: (1) IN GENERAL.—The Secretary shall establish a task force to be known as the National Task Force on Fetal Alcohol
p.000523: Syn- drome and Fetal Alcohol Effect (referred to in this subsection as the ‘‘Task Force’’) to foster
p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
p.000523: hol Effect, including programs and research concerning education and public awareness for relevant service
p.000523: pro- viders, school-age children, women at-risk, and the general public, medical diagnosis, interventions for
p.000523: women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and
p.000523: beneficial services for indi- viduals with Fetal Alcohol Syndrome and Fetal Alcohol Ef- fect and their families;
p.000523: (B) coordinate its efforts with the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the
p.000523: De- partment of Health and Human Services; and
p.000523: (C) report on a biennial basis to the Secretary and rel- evant committees of Congress on the current and planned
p.000523: activities of the participating agencies.
p.000523: (4) TIME FOR APPOINTMENT.—The members of the Task Force shall be appointed by the Secretary not later
p.000523: than 6 months after the date of enactment of this part.
...

p.000745: (1) provide for the coordination of the activities of the na- tional research institutes; and
p.000745: (2) coordinate the aspects of all Federal health programs and activities relating to deafness and other
p.000745: communication disorders in order to assure the adequacy and technical sound- ness of such programs and activities and
p.000745: in order to provide for the full communication and exchange of information necessary to maintain adequate coordination
p.000745: of such programs and activi- ties.
p.000745: (c) The Coordinating Committee shall be composed of the direc- tors of each of the national research institutes
p.000745: and divisions in- volved in research with respect to deafness and other communica- tion disorders and
p.000745: representatives of all other Federal departments and agencies whose programs involve health functions or
p.000745: respon- sibilities relevant to deafness and other communication disorders.
p.000745: (d) The Coordinating Committee shall be chaired by the Direc- tor of NIH (or the designee of the Director).
p.000745: The Committee shall meet at the call of the chair, but not less often than four times a year.
p.000745: LIMITATION ON ADMINISTRATIVE EXPENSES
p.000745: SEC. 464F. ø285m–6¿ With respect to amounts appropriated for a fiscal year for the National Institutes of
p.000745: Health, the limitation established in section 408(a)(1) on the expenditure of such amounts for administrative expenses
p.000745: shall apply to administrative expenses of the National Institute on Deafness and Other Communication Disorders.
p.000745: Subpart 14—National Institute on Alcohol Abuse and Alcoholism
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
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p.000745:
p.000745:
p.000745:
p.000745:
p.000745: January 30, 2020
p.000745:
p.000745: PURPOSE OF INSTITUTE
p.000745: SEC. 464H. ø285n¿ (a) IN GENERAL.—The general purpose of the National Institute on Alcohol Abuse and
p.000745: Alcoholism (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of
p.000745: biomedical and behavioral research, health services re- search, research training, and health information
p.000745: dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism.
p.000745: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000745: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of alcohol
p.000745: abuse and alcoholism. In carrying out the program, the Director of the Institute is author- ized to—
p.000745: (1) collect and disseminate through publications and other appropriate means (including the development of
p.000745: curriculum materials), information as to, and the practical application of, the research and other activities
p.000745: under the program;
p.000745: (2) make available research facilities of the Public Health Service to appropriate public authorities, and to
p.000745: health officials and scientists engaged in special study;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000745:
p.000745:
p.000745:
p.000745:
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p.000745:
p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
p.000745:
p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
p.000745: (6) conduct an intramural program of biomedical, behav- ioral, epidemiological, and social research,
p.000745: including research into the most effective means of treatment and service deliv- ery, and including
p.000745: research involving human subjects, which is—
p.000745: (A) located in an institution capable of providing all necessary medical care for such human subjects,
p.000745: including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and
p.000745: intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is
p.000745: determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
p.000745:
p.000745:
p.000745:
p.000745:
p.000745:
p.000745: January 30, 2020
p.000745: (B) associated with an accredited medical or research training institution;
p.000745: (7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health
p.000745: Service, persons not otherwise eligible for such treatment;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000745:
p.000745:
p.000745:
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p.000745:
p.000745:
p.000747: 747
p.000747: PUBLIC HEALTH SERVICE ACT
p.000747: Sec. 464J
p.000747:
p.000747: (8) provide to health officials, scientists, and appropriate public and other nonprofit institutions and
p.000747: organizations, tech- nical advice and assistance on the application of statistical and other scientific research
p.000747: methods to experiments, studies, and surveys in health and medical fields;
p.000747: (9) enter into contracts under this title without regard to sections 3648 and 3709 of the Revised
p.000747: Statutes (31 U.S.C. 529; 39 41 U.S.C. 5); and
p.000747: (10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and Alcoholism, such
p.000747: additional means as he deems necessary or appropriate to carry out the purposes of this section.
p.000747: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000747: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000747: Institute and in disseminating the results of such research to health professionals and the general public.
p.000747: ASSOCIATE DIRECTOR FOR PREVENTION
p.000747: SEC. 464I. ø285n–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000747: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000747: concerning the prevention of alcohol abuse and al- coholism. The Associate Director shall be appointed by the Director
p.000747: of the Institute from individuals who because of their professional training or expertise are experts in
p.000747: alcohol abuse and alcoholism or the prevention of such.
p.000747: (b) BIENNIAL REPORT.—The Associate Director for Prevention shall prepare for inclusion in the biennial
p.000747: report made under sec- tion 407 a description of the prevention activities of the Institute, including a
p.000747: description of the staff and resources allocated to those activities.
p.000747: NATIONAL ALCOHOL RESEARCH CENTER
p.000747: SEC. 464J. ø285n–2¿ (a) The Secretary acting through the In- stitute may designate National Alcohol
p.000747: Research Centers for the purpose of interdisciplinary research relating to alcoholism and other biomedical,
p.000747: behavioral, and social issues related to alcoholism and alcohol abuse. No entity may be designated as a Center unless
p.000747: an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be
p.000747: submitted in such man- ner and contain such information as the Secretary may reasonably require. The Secretary may
p.000747: not approve such an application un- less—
p.000747: (1) the application contains or is supported by reasonable assurances that—
p.000747: (A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social,
p.000747: and re- lated disciplines, long-term research on alcoholism and other alcohol problems and to provide
p.000747: coordination of such research among such disciplines;
p.000747:
p.000747:
p.000747:
p.000747: January 30, 2020
p.000747: 39 Now codified to section 3324 of title 31, United States Code.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000747:
p.000747:
p.000747:
p.000747:
p.000747:
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p.000747:
p.000747: Sec. 464L PUBLIC HEALTH SERVICE ACT 748
p.000747:
p.000747: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000747: facili- ties) to carry out the research plan contained in the appli- cation,
p.000747: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000747: alco- holism and other alcohol problems;
p.000747: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000747: alco- holism and other alcohol problems;
p.000747: (E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol
p.000747: problems for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other
p.000747: specialized grad- uate students; and
p.000747: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000747: social service fields as the Secretary may require. 40
p.000747: (2) the application contains a detailed five-year plan for re- search relating to alcoholism and other alcohol
p.000747: problems.
p.000747: (b) The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to
p.000747: Centers which have been designated under this section. No funds provided under a grant under this subsection may be
p.000747: used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For
p.000747: the purposes of the preceding sentence, the term ‘‘con- struction’’ has the meaning given that term by section
p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
...

p.000751: (2) encourage and promote (through grants, contracts, international collaboration, or otherwise)
p.000751: expanded research programs, investigations, experiments, community trials, and studies, into the development
p.000751: and use of medications to treat drug addiction;
p.000751: (3) establish or provide for the establishment of research facilities;
p.000751: (4) report on the activities of other relevant agencies relat- ing to the development and use of
p.000751: pharmacotherapeutic treat- ments for drug addiction;
p.000751: (5) collect, analyze, and disseminate data useful in the de- velopment and use of pharmacotherapeutic treatments for
p.000751: drug addiction and collect, catalog, analyze, and disseminate through international channels, the
p.000751: results of such research;
p.000751: ctly or through grants, contracts, or cooperative agree- ments, support training in the fundamental
p.000751: sciences and clin- ical disciplines related to the pharmacotherapeutic treatment of drug abuse, including
p.000751: the use of training stipends, fellow- ships, and awards where appropriate; and
p.000751: (7) coordinate the activities conducted under this section with related activities conducted within the National
p.000751: Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate
p.000751: institutes and shall con- sult with the Directors of such Institutes.
p.000751: (b) DUTIES.—In carrying out the activities described in sub- section (a), the Director of the Institute—
p.000751: (1) shall collect and disseminate through publications and other appropriate means, information pertaining
p.000751: to the re- search and other activities under this section;
p.000751: (2) shall make grants to or enter into contracts and cooper- ative agreements with individuals and public and private
p.000751: enti- ties to further the goals of the program;
p.000751: (3) may, in accordance with section 496, and in consulta- tion with the National Advisory Council on
p.000751: Drug Abuse, ac- quire, construct, improve, repair, operate, and maintain pharmacotherapeutic research
p.000751: centers, laboratories, and other
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000751:
p.000751:
p.000751:
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p.000751: Sec. 464R PUBLIC HEALTH SERVICE ACT 752
p.000751:
p.000751: necessary facilities and equipment, and such other real or per- sonal property as the Director determines necessary,
p.000751: and may, in consultation with such Advisory Council, make grants for the construction or renovation of
p.000751: facilities to carry out the pur- poses of this section;
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p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
p.000807: part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental
p.000807: health be used collaboratively, as appropriate, and in consultation with the Agency for Health Care
p.000807: Policy Re- search.
p.000807:
p.000807:
p.000807:
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p.000807:
p.000807: January 30, 2020
p.000807: ANIMALS IN RESEARCH
p.000807: SEC. 495. ø289d¿ (a) The Secretary, acting through the Direc- tor of NIH, shall establish guidelines for the
p.000807: following:
p.000807: (1) The proper care of animals to be used in biomedical and behavioral research.
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000809: PUBLIC HEALTH SERVICE ACT
p.000809: Sec. 495
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p.000809: (2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall
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p.000825: intervention strategies to reduce the risks of HIV, hepatitis, tuberculosis, and other communicable diseases
p.000825: among individuals with mental or substance use dis- orders, and to develop appropriate mental health
p.000825: services for individuals with such diseases or disorders;
p.000825: (7) coordinate Federal policy with respect to the provision of treatment services for substance use
p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
p.000825: delivery and effectiveness of prevention, treat- ment, and recovery support services and are appropriately
p.000825: in- corporated into programs carried out by the Administration;
p.000825: (10) encourage public and private entities that provide health insurance to provide benefits for substance use
p.000825: disorder and mental health services;
p.000825: (11) work with relevant agencies of the Department of Health and Human Services on integrating mental health
p.000825: pro- motion and substance use disorder prevention with general health promotion and disease prevention and
p.000825: integrating men- tal and substance use disorders treatment services with phys- ical health treatment services;
p.000825: (12) monitor compliance by hospitals and other facilities with the requirements of sections 542 and 543;
p.000825: (13) with respect to grant programs authorized under this title or part B of title XIX, or grant programs otherwise
p.000825: funded by the Administration—
p.000825: (A) require that all grants that are awarded for the provision of services are subject to performance
p.000825: and out- come evaluations;
p.000825: (B) ensure that the director of each Center of the Ad- ministration consistently documents the application of cri-
p.000825: teria when awarding grants and the ongoing oversight of grantees after such grants are awarded;
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000825:
p.000825:
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p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
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p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
p.000827: evaluating service pro- grams for the prevention and treatment of alcoholism and alco- hol abuse within the
p.000827: Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center for Mental Health
p.000827: Services, and coordinating such programs among the Centers, and among the Centers and other public
p.000827: and private entities. The Associate Administrator also may en- sure that alcohol prevention, education, and
p.000827: policy strategies are integrated into all programs of the Centers that address substance abuse prevention,
p.000827: education, and policy, and that the Center for Substance Abuse Prevention addresses the Healthy
p.000827: People 2010 goals and the National Dietary Guide-
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: 829
p.000829: PUBLIC HEALTH SERVICE ACT
p.000829: Sec. 501
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p.000829: January 30, 2020
p.000829: lines of the Department of Health and Human Services and the Department of Agriculture related to alcohol
p.000829: consumption.
p.000829: (2) PLAN.—
p.000829: (A) The Assistant Secretary, acting through the Asso- ciate Administrator for Alcohol Prevention and
p.000829: Treatment Policy, shall develop, and periodically review and as appro- priate revise, a plan for programs and policies
p.000829: to treat and prevent alcoholism and alcohol abuse. The plan shall be developed (and reviewed and revised) in
p.000829: collaboration with the Directors of the Centers of the Administration and in consultation with members of
p.000829: other Federal agencies and public and private entities.
p.000829: (B) Not later than 1 year after the date of the enact- ment of the ADAMHA Reorganization Act, the
p.000829: Assistant Secretary shall submit to the Congress the first plan devel- oped under subparagraph (A).
p.000829: (3) REPORT.—
p.000829: (A) Not less than once during each 2 years, the Assist- ant Secretary, acting through the Associate Administrator for
p.000829: Alcohol Prevention and Treatment Policy, shall prepare a report describing the alcoholism and alcohol abuse
p.000829: pre- vention and treatment programs undertaken by the Ad- ministration and its agencies, and the report shall
p.000829: include a detailed statement of the expenditures made for the ac- tivities reported on and the personnel
p.000829: used in connection with such activities.
p.000829: (B) Each report under subparagraph (A) shall include a description of any revisions in the plan under paragraph
p.000829: (2) made during the preceding 2 years.
p.000829: (C) Each report under subparagraph (A) shall be sub- mitted to the Assistant Secretary for inclusion in the bien- nial
p.000829: report under subsection (m).
p.000829: (f) ASSOCIATE ADMINISTRATOR FOR WOMEN’S SERVICES.—
p.000829: (1) APPOINTMENT.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint an Associate
p.000829: Adminis- trator for Women’s Services who shall report directly to the As- sistant Secretary.
p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
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p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
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p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
p.000839: members to be appointed by the Secretary under paragraph (3).
p.000839: (2) EX OFFICIO MEMBERS.—The ex officio members of an advisory council shall consist of—
p.000839: (A) the Secretary;
p.000839: (B) the Assistant Secretary;
p.000839: (C) the Director of the Center for which the council is established;
p.000839: (D) the Under Secretary for Health of the Department of Veterans Affairs;
p.000839: (E) the Assistant Secretary for Defense for Health Af- fairs (or the designates of such officers);
p.000839: (F) the Chief Medical Officer, appointed under section 501(g);
p.000839: (G) the Director of the National Institute of Mental Health for the advisory councils appointed
p.000839: under sub- sections (a)(1)(A) and (a)(1)(D);
p.000839: (H) the Director of the National Institute on Drug Abuse for the advisory councils appointed under
p.000839: sub- sections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.000839: (I) the Director of the National Institute on Alcohol Abuse and Alcoholism for the advisory councils
p.000839: appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and
p.000839: (J) such additional officers or employees of the United States as the Secretary determines necessary for the advi- sory
p.000839: council to effectively carry out its functions.
p.000839: (3) APPOINTED MEMBERS.—Individuals shall be appointed to an advisory council under paragraph (1) as follows:
p.000839: (A) Nine of the members shall be appointed by the Secretary from among the leading representatives of
p.000839: the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
p.000839: the Admin- istration or Center for which the advisory council is estab- lished.
p.000839: (B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders
p.000839: in fields of public policy, public relations, law, health policy economics, or management.
p.000839: (C) Not less than half of the members of the advisory council appointed under subsection (a)(1)(D)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree in psychology; or
p.000839: (III) have an advanced degree in nursing or social work from an accredited graduate school or be a certified
p.000839: physician assistant; and
p.000839: (ii) shall specialize in the mental health field.
p.000839: (D) Not less than half of the members of the advisory councils appointed under subsections (a)(1)(B) and
p.000839: (a)(1)(C)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree; or
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000841: or Center for which the advisory council is established to serve as the Executive Secretary of the
p.000841: advisory council. The Assistant Secretary or Director shall make available to the advisory council such staff,
p.000841: information, and other assistance
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000841: Sec. 503 PUBLIC HEALTH SERVICE ACT 842
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p.000841: as it may require to carry out its functions. The Assistant Sec- retary or Director shall provide
p.000841: orientation and training for new members of the advisory council to provide for their effective par-
p.000841: ticipation in the functions of the advisory council.
p.000841: REPORTS ON ALCOHOLISM, ALCOHOL ABUSE, AND DRUG ABUSE
p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
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p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847:
p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
p.000847: (5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the
p.000847: National Institute on Alcohol Abuse and Alcoholism, and with the States to promote the study, dissemination, and
p.000847: implementation of research find- ings that will improve the delivery and effectiveness of treat- ment
p.000847: services;
p.000847: (6) collaborate with the Administrator of the Health Re- sources and Services Administration and the
p.000847: Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into
p.000847: the mainstream of the health care system of the United States of programs for providing treat- ment
p.000847: services;
p.000847: (7) evaluate plans submitted by the States pursuant to sec- tion 1932(a)(6) in order to determine whether the
p.000847: plans ade- quately provide for the availability, allocation, and effective- ness of treatment services;
p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
p.000847: private entities;
...

p.000859:
p.000859: January 30, 2020
p.000859:
p.000859: CENTER FOR SUBSTANCE ABUSE PREVENTION
p.000859: SEC. 515. ø290bb–21¿ (a) There is established in the Adminis- tration a Center for Substance Abuse Prevention
p.000859: (hereafter re- ferred to in this part as the ‘‘Prevention Center’’). The Prevention Center shall be
p.000859: headed by a Director appointed by the Secretary from individuals with extensive experience or academic
p.000859: qualifica- tions in the prevention of drug or alcohol abuse.
p.000859: (b) The Director of the Prevention Center shall—
p.000859: (1) sponsor regional workshops on the prevention of drug and alcohol abuse through the reduction of risk
p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000863:
p.000863:
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
...

p.000955: financial re- sources and, at the option of the State, rural communities;
p.000955: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000955:
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p.000955: Sec. 604 PUBLIC HEALTH SERVICE ACT 956
p.000955:
p.000955: (2) in the case of projects for the construction of rehabilita- tion facilities, to facilities operated in connection
p.000955: with a univer- sity teaching hospital which will provide an integrated pro- gram of medical, psychological,
p.000955: social, and vocational evalua- tion and services under competent supervision;
p.000955: (3) in the case of projects for modernization of facilities, to facilities serving densely populated areas;
p.000955: (4) in the case of projects for construction or modernization of outpatient facilities, to any outpatient facility that
p.000955: will be lo- cated in, and provide services for residents of, an area deter- mined by the Secretary to be a
p.000955: rural or urban poverty area;
p.000955: (5) to projects for facilities which, alone or in conjunction with other facilities, will provide
p.000955: comprehensive health care, including outpatient and preventive care as well as hospitaliza- tion;
p.000955: (6) to facilities which will provide training in health or al- lied health professions; and
p.000955: (7) to facilities which will provide to a significant extent, for the treatment of alcoholism;
p.000955: (b) general standards of construction and equipment for facili- ties of different classes and in different
p.000955: types of location, for which assistance is available under this part;
p.000955: (c) criteria for determining needs for general hospital and long- term care beds, and needs for hospitals and
p.000955: other facilities for which aid under this part is available, and for developing plans for the distribution of such
p.000955: beds and facilities;
p.000955: (d) criteria for determining the extent to which existing facili- ties, for which aid under this part is
p.000955: available, are in need of mod- ernization; and
p.000955: (e) that the State plan shall provide for adequate hospitals, and other facilities for which aid under
p.000955: this part is available, for all persons residing in the State, and adequate hospitals (and such other facilities)
p.000955: to furnish needed services for persons unable to pay therefor. Such regulations may also require that before approval
p.000955: of an application for a project is recommended by a State agency to the Surgeon General for approval
p.000955: under this part, assurance shall be received by the State from the applicant that (1) the facility or
p.000955: portion thereof to be constructed or modernized will be made avail- able to all persons residing in the territorial
p.000955: area of the applicant; and (2) there will be made available in the facility or portion there- of to be constructed or
p.000955: modernized a reasonable volume of services to persons unable to pay therefor, but an exception shall be made
p.000955: if such a requirement is not feasible from a financial viewpoint.
p.000955:
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p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001269:
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p.001269:
p.001269:
p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
p.001271: dis- eases; and shall be designed to reach populations of different languages and of different social and
p.001271: economic backgrounds.
p.001271: (2) Securing the cooperation of the communication media, providers of health care, schools, and others in
p.001271: activities de- signed to promote and encourage the use of health maintaining information and behavior.
p.001271: (3) The study of health information and promotion in ad- vertising and the making to concerned Federal
p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others of information for use by the public respecting health in- surance policies and prepaid health plans,
p.001271: including informa- tion on the benefits provided by the various types of such poli- cies and plans, the premium
p.001271: charges for such policies and plans, exclusions from coverage or eligibility for coverage, cost sharing
p.001271: requirements, and the ratio of the amounts paid as benefits to the amounts received as premiums and information
p.001271: to enable the public to make relevant comparisons of the costs and benefits of such policies and plans.
p.001271:
p.001271:
p.001271:
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Health / degenerative conditions

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p.001199: 1199
p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
p.001199:
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p.001199: January 30, 2020
p.001199: with other Federal agencies that carry out activities regarding traumatic brain injury.
p.001199: (g) REPORT.—Not less than biennially, the Secretary shall sub- mit to the Committee on Energy and Commerce of
p.001199: the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions of the
p.001199: Senate, a report describing the findings and results of the programs established under this section and sec- tion
p.001199: 1253, including measures of outcomes and consumer and sur- rogate satisfaction.
p.001199: (h) DEFINITIONS.—For purposes of this section:
p.001199: (1) The terms ‘‘American Indian consortium’’ and ‘‘State’’ have the meanings given to those terms in section
p.001199: 1253.
p.001199: (2) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001199: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001199: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001199: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001199: private entities.
p.001199: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001199: to be appropriated
p.001199: $7,321,000 for each of fiscal years 2020 through 2024.
p.001199: SEC. 1253. ø300d–53¿ STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.
p.001199: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001199: Living, shall make grants to protection and advocacy systems for the purpose of ena- bling such systems
p.001199: to provide services to individuals with trau- matic brain injury.
p.001199: (b) SERVICES PROVIDED.—Services provided under this section may include the provision of—
p.001199: (1) information, referrals, and advice;
p.001199: (2) individual and family advocacy;
p.001199: (3) legal representation; and
p.001199: (4) specific assistance in self-advocacy.
p.001199: (c) APPLICATION.—To be eligible to receive a grant under this section, a protection and advocacy system shall
p.001199: submit an applica- tion to the Secretary at such time, in such form and manner, and accompanied by such
p.001199: information and assurances as the Secretary may require.
...

p.001205: ferred to as the ‘‘Coordinating Committee’’).
p.001205: (2) DUTIES.—The Coordinating Committee shall make rec- ommendations regarding—
p.001205: (A) the activities of the Program to be carried out by each of the agencies represented on the Committee and
p.001205: the amount of funds needed by each of the agencies for such activities; and
p.001205: (B) effective collaboration among the agencies in car- rying out the activities.
p.001205: (3) COMPOSITION.—The Coordinating Committee shall be composed of the Directors of each of the agencies
p.001205: that, under subsection (c), have responsibilities under the Program, and any other individuals who are
p.001205: practitioners in the trauma field as designated by the Director of the National Institutes of Health.
p.001205: (h) DEFINITIONS.—For purposes of this section:
p.001205: (1) The term ‘‘designated trauma center’’ has the meaning given such term in section 1231(1).
p.001205: (2) The term ‘‘Director’’ means the Director of the National Institutes of Health.
p.001205: (3) The term ‘‘trauma’’ means an injury resulting from ex- posure to—
p.001205: (A) a mechanical force; or
p.001205: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001205: radioactive.
p.001205: (4) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001205: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001205: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001205: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001205: private entities.
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001205:
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p.001205: Sec. 1271 PUBLIC HEALTH SERVICE ACT 1206
p.001205:
p.001205: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001205: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005, and such
p.001205: sums as may be necessary for each of the fiscal years 2009 through 2012.
p.001205: PART G—POISON CONTROL
p.001205: SEC. 1271. ø300d–71¿ MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER AND OTHER COMMUNICATION CAPABILITIES.
p.001205: (a) IN GENERAL.—The Secretary—
p.001205: (1) shall provide coordination and assistance to poison con- trol centers for the establishment and maintenance of a
p.001205: nation- wide toll-free phone number, to be used to access such centers; and
p.001205:
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p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
p.000017: statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and
p.000017: demonstrations respecting the assessment of health care technology authorized by this Act through the Agency
p.000017: for Health Care Policy and Research and the National Center for Health Sta- tistics.
p.000017:
p.000017: NATIONAL CENTER FOR HEALTH STATISTICS
p.000017: SEC. 306. 3 ø242k¿ (a) There is established in the Department of Health and Human Services the National Center
p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
p.000017: acute and chronic ill- nesses, and infant and maternal morbidity and mortality,
p.000017: (B) the impact of illness and disability of the popu- lation on the economy of the United States and
p.000017: on other aspects of the well-being of its population (or of such groupings),
p.000017: (C) environmental, social, and other health hazards,
p.000017: (D) determinants of health,
p.000017: (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty
p.000017: and type of practice and the supply of services by hospitals, ex- tended care facilities, home health agencies,
p.000017: and other health institutions,
p.000017: (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types
p.000017: of practice of the health professionals providing such serv- ices, and (ii) services of hospitals,
p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000369: SEC. 340E. ø256e¿ PROGRAM OF PAYMENTS TO CHILDREN’S HOS- PITALS THAT OPERATE GRADUATE MEDICAL EDUCATION
p.000369: PROGRAMS.
p.000369: (a) PAYMENTS.—The Secretary shall make two payments under this section to each children’s hospital for each of fiscal
p.000369: years 2000 through 2005, each of fiscal years 2007 through 2011, each of fiscal years 2014 through 2018, and each
p.000369: of fiscal years 2019 through 2023, one for the direct expenses and the other for indirect ex- penses
p.000369: associated with operating approved graduate medical resi- dency training programs. The Secretary shall
p.000369: promulgate regula- tions pursuant to the rulemaking requirements of title 5, United States Code, which
p.000369: shall govern payments made under this sub- part.
p.000369: (b) AMOUNT OF PAYMENTS.—
p.000369: (1) IN GENERAL.—Subject to paragraphs (2) and (3), the amounts payable under this section to a children’s
p.000369: hospital for an approved graduate medical residency training program for a fiscal year are each of the following
p.000369: amounts:
p.000369: (A) DIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (c) for direct expenses associated
p.000369: with operating approved graduate medical residency train- ing programs.
p.000369: (B) INDIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (d) for indirect expenses associ-
p.000369: ated with the treatment of more severely ill patients and the additional costs relating to teaching
p.000369: residents in such programs.
p.000369: (2) CAPPED AMOUNT.—
p.000369: (A) IN GENERAL.—The total of the payments made to children’s hospitals under paragraph (1)(A) or
p.000369: paragraph (1)(B) in a fiscal year shall not exceed the funds appro- priated under paragraph (1) or (2),
p.000369: respectively, of sub- section (f) for such payments for that fiscal year.
p.000369: (B) PRO RATA REDUCTIONS OF PAYMENTS FOR DIRECT EXPENSES.—If the Secretary determines that the amount of
p.000369: funds appropriated under subsection (f)(1) for a fiscal year is insufficient to provide the total amount of payments
p.000369: oth- erwise due for such periods under paragraph (1)(A), the Secretary shall reduce the amounts so
p.000369: payable on a pro rata basis to reflect such shortfall.
p.000369: (3) ANNUAL REPORTING REQUIRED.—
p.000369: (A) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
p.000369: (i) IN GENERAL.—The amount payable under this section to a children’s hospital for a fiscal year (begin- ning
p.000369: with fiscal year 2008 and after taking into ac- count paragraph (2)) shall be reduced by 25 percent if the
p.000369: Secretary determines that—
p.000369: (I) the hospital has failed to provide the Sec- retary, as an addendum to the hospital’s applica- tion
p.000369: under this section for such fiscal year, the re- port required under subparagraph (B) for the pre- vious fiscal year;
p.000369: or
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000369:
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p.000373: amount equal to the average of the standardized per resi- dent amounts computed under subparagraph (C) for such
p.000373: hospitals, with the amount for each hospital weighted by the average number of full-time equivalent
p.000373: residents at such hospital.
p.000373: (E) APPLICATION TO INDIVIDUAL HOSPITALS.—The Sec- retary shall compute for each such hospital that is a
p.000373: chil- dren’s hospital a per resident amount—
p.000373: (i) by dividing the national average per resident amount computed under subparagraph (D) into a
p.000373: wage-related portion and a non-wage-related portion by applying the proportion determined under subpara- graph
p.000373: (B);
p.000373: (ii) by multiplying the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social Security
p.000373: Act for discharges occurring during the pre- ceding fiscal year for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (F) UPDATING RATE.—The Secretary shall update such per resident amount for each such children’s hospital by the
p.000373: estimated percentage increase in the consumer price index for all urban consumers during the period beginning
p.000373: October 1997 and ending with the midpoint of the Federal fiscal year for which payments are made.
p.000373: (d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
p.000373: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for
p.000373: indirect ex- penses associated with the treatment of more severely ill pa- tients and the additional
p.000373: costs associated with the teaching of residents for a fiscal year is equal to an amount determined
p.000373: appropriate by the Secretary.
p.000373: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000373: Sec. 340E PUBLIC HEALTH SERVICE ACT 374
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p.000373: January 30, 2020
p.000373:
p.000373: (2) FACTORS.—In determining the amount under para- graph (1), the Secretary shall—
p.000373: (A) take into account variations in case mix among children’s hospitals and the ratio of the number of
p.000373: full- time equivalent residents in the hospitals’ approved grad- uate medical residency training programs to
p.000373: beds (but ex- cluding beds or bassinets assigned to healthy newborn in- fants); and
p.000373: (B) assure that the aggregate of the payments for indi- rect expenses associated with the treatment of more se-
p.000373: verely ill patients and the additional costs related to the teaching of residents under this section in a
p.000373: fiscal year are equal to the amount appropriated for such expenses for the fiscal year involved under subsection
p.000373: (f)(2).
p.000373: (e) MAKING OF PAYMENTS.—
p.000373: (1) INTERIM PAYMENTS.—The Secretary shall determine, before the beginning of each fiscal year involved for which
p.000373: pay- ments may be made for a hospital under this section, the amounts of the payments for direct graduate
p.000373: medical education and indirect medical education for such fiscal year and shall (subject to paragraph (2))
p.000373: make the payments of such amounts in 12 equal interim installments during such period. Such in- terim
p.000373: payments to each individual hospital shall be based on the number of residents reported in the
p.000373: hospital’s most re- cently filed Medicare cost report prior to the application date for the Federal
p.000373: fiscal year for which the interim payment amounts are established. In the case of a hospital that does not report
p.000373: residents on a Medicare cost report, such interim pay- ments shall be based on the number of residents
p.000373: trained dur- ing the hospital’s most recently completed Medicare cost report filing period.
p.000373: (2) WITHHOLDING.—The Secretary shall withhold up to 25 percent from each interim installment for direct
p.000373: and indirect graduate medical education paid under paragraph (1) as nec- essary to ensure a hospital will not
p.000373: be overpaid on an interim basis.
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p.000527: January 30, 2020
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p.000527: (G) CIVIL LIABILITY PROTECTION LAW.—The certifi- cation required in subparagraph (F) shall be a
p.000527: certification made by the State attorney general that the State has re- viewed any applicable civil liability
p.000527: protection law to deter- mine the application of such law with regard to elemen- tary and secondary school
p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
...

p.000699: (G) the education (including continuing education) and training of scientists, clinical investigators, and
p.000699: educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs
p.000699: respecting heart, blood vessel, lung, and blood diseases and blood resources;
p.000699: (H) public and professional education relating to all as- pects of such diseases, including the
p.000699: prevention of such dis- eases, and the use of blood and blood products and the man- agement of blood
p.000699: resources;
p.000699: (I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of
p.000699: children (includ- ing cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and
p.000699: Cooley’s anemia, and hemophilic dis- eases) and for the development and demonstration of diag- nostic,
p.000699: treatment, and preventive approaches to such diseases; and
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p.000699: (J) establishment of programs for study, research, develop- ment, demonstrations and evaluation of emergency
p.000699: medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.
p.000699: (2) The Program shall be coordinated with other national re- search institutes to the extent that they
p.000699: have responsibilities re- specting such diseases and shall give special emphasis to the con- tinued
p.000699: development in the Institute of programs related to the causes of stroke and to effective coordination of such
p.000699: programs with related stroke programs in the National Institute of Neurological and Communicative Disorders
p.000699: and Stroke. The Director of the In- stitute, with the advice of the advisory council for the Institute,
p.000699: shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
p.000699: (b) In carrying out the Program, the Director of the Institute, under policies established by the Director of
p.000699: NIH—
p.000699: (1) may, after consultation with the advisory council for the Institute, obtain (in accordance with
p.000699: section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period
p.000699: of such service) the services of not more than one hundred experts or consultants who have sci- entific
p.000699: or professional qualifications;
p.000699: (2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve,
p.000699: repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood
p.000699: resource laboratories, research, train- ing, and other facilities, equipment, and such other real or per- sonal
p.000699: property as the Director determines necessary;
...

p.000751: submitted the following Feb- ruary 1 under section 1005 of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
p.000751: (d) DEFINITION.—For purposes of this section, the term ‘‘pharmacotherapeutics’’ means medications used to
p.000751: treat the symp- toms and disease of drug abuse, including medications to—
p.000751: (1) block the effects of abused drugs;
p.000751: (2) reduce the craving for abused drugs;
p.000751: (3) moderate or eliminate withdrawal symptoms;
p.000751: (4) block or reverse the toxic effect of abused drugs; or
p.000751: (5) prevent relapse in persons who have been detoxified from drugs of abuse.
p.000751: Subpart 16—National Institute of Mental Health
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p.000751: PURPOSE OF INSTITUTE
p.000751: SEC. 464R. ø285p¿ (a) IN GENERAL.—The general purpose of the National Institute of Mental Health
p.000751: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of bio- medical
p.000751: and behavioral research, health services research, research training, and health information dissemination with respect
p.000751: to the cause, diagnosis, treatment, control and prevention of mental ill- ness.
p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: 753
p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
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p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
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p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
p.000837:
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p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
p.000837:
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p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
p.000875: (11) conduct services-related assessments, including eval- uations of the organization and financing of care,
p.000875: self-help and consumer-run programs, mental health economics, mental health service systems, rural mental
p.000875: health and tele-mental health, and improve the capacity of State to conduct evalua- tions of publicly
p.000875: funded mental health programs;
p.000875: (12) disseminate mental health information, including evi- dence-based practices, to States, political
p.000875: subdivisions, edu- cational agencies and institutions, treatment and prevention service providers, and the
p.000875: general public, including information concerning the practical application of research supported by the
p.000875: National Institute of Mental Health that is applicable to improving the delivery of services;
p.000875: (13) provide technical assistance to public and private enti- ties that are providers of mental health services;
p.000875: (14) monitor and enforce obligations incurred by commu- nity mental health centers pursuant to the Community
p.000875: Mental Health Centers Act (as in effect prior to the repeal of such Act on August 13, 1981, by section
p.000875: 902(e)(2)(B) of Public Law 97– 35 (95 Stat. 560));
p.000875: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000875:
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p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
p.000895: (4) APPLICATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that desires a grant under this subsection shall submit an ap- plication to the Secretary at such
p.000895: time, in such manner, and containing such information as the Secretary may require, in- cluding a plan for
p.000895: the rigorous evaluation of activities that are carried out with funds received under a grant under this sub-
p.000895: section.
p.000895: (5) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private en- tity receiving a grant under this subsection shall use funds from such grant for
p.000895: evidence-based programs that provide training and education in accordance with paragraph (1) on matters
p.000895: including—
p.000895: (A) recognizing the signs and symptoms of mental ill- ness; and
p.000895: (B)(i) resources available in the community for individ- uals with a mental illness and other relevant resources; or
p.000895: (ii) safely de-escalating crisis situations involving indi- viduals with a mental illness.
p.000895: (6) EVALUATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that receives a grant under this subsection shall prepare and submit an evaluation to the
p.000895: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require,
p.000895: including an evaluation of activities carried out with funds received under the grant under this subsection and a
p.000895: process and outcome evaluation.
p.000895: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this
p.000895: subsection$14,693,000 for each of fiscal years 2018 through 2022.
p.000895: SEC. 520K. ø290bb–42¿ INTEGRATION INCENTIVE GRANTS AND COOP- ERATIVE AGREEMENTS.
p.000895: (a) DEFINITIONS.—In this section:
p.000895: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, or other appropriate State agency, in
p.000895: collaboration with 1 or more qualified community programs as described in sec- tion 1913(b)(1) or 1 or
p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
p.000895: and physical
p.000895:
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p.000897: (2) ADJUSTMENT PERMITTED.—The Secretary, taking into consideration the quality of the application and the number
p.000897: of eligible entities that received grants under this section prior to the date of enactment of the Helping
p.000897: Families in Mental Health Crisis Reform Act of 2016, may adjust the target amount that an
p.000897: eligible entity may receive for a year through a grant or cooperative agreement under this section.
p.000897: (3) LIMITATION.—An eligible entity receiving funding under this section may not allocate more than 10 percent
p.000897: of funds awarded under this section to administrative functions, and the remaining amounts shall be
p.000897: allocated to health facilities that provide integrated care.
p.000897: (e) DURATION.—A grant or cooperative agreement under this section shall be for a period not to exceed 5 years.
p.000897: (f) REPORT ON PROGRAM OUTCOMES.—An eligible entity receiv- ing a grant or cooperative agreement under this section
p.000897: shall sub- mit an annual report to the Secretary that includes—
p.000897: (1) the progress made to reduce barriers to integrated care as described in the entity’s application under
p.000897: subsection (c); and
p.000897:
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p.000897: (2) a description of functional outcomes of special popu- lations, including—
p.000897: (A) with respect to adults with a serious mental ill- ness, participation in supportive housing or
p.000897: independent living programs, attendance in social and rehabilitative programs, participation in job training
p.000897: opportunities, satis- factory performance in work settings, attendance at sched- uled medical and mental health
p.000897: appointments, and compli- ance with prescribed medication regimes;
p.000897: (B) with respect to individuals with co-occurring men- tal illness and physical health conditions and chronic
p.000897: dis- eases, attendance at scheduled medical and mental health appointments, compliance with prescribed medication
p.000897: re- gimes, and participation in learning opportunities related to improved health and lifestyle practices; and
p.000897: (C) with respect to children and adolescents with a se- rious emotional disturbance who have co-occurring phys-
p.000897: ical health conditions and chronic diseases, attendance at scheduled medical and mental health
p.000897: appointments, com- pliance with prescribed medication regimes, and participa- tion in learning opportunities at school
p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
p.000897:
p.000897:
p.000897:
p.000897:
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p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
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p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
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p.000901:
p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that not more than 4 percent of the payments will be expended for ad- ministrative
...

p.000941: holding of a resident for the purpose of conducting routine physical examinations or tests or to protect
p.000941: the resident from fall- ing out of bed or to permit the resident to participate in activities without the
p.000941: risk of physical harm to the resident (such term does not include a physical escort); and
p.000941: (B) a drug or medication that is used as a restraint to control behavior or restrict the resident’s freedom of move-
p.000941: ment that is not a standard treatment for the resident’s medical or psychiatric condition.
p.000941: (2) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000941: term does not include a time out.
p.000941: (3) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000941: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000941: (4) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000941: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000941: for the purpose of calming. Time out is not seclusion.
p.000941: SEC. 592. ø290ii–1¿ REPORTING REQUIREMENT.
p.000941: (a) IN GENERAL.—Each facility to which the Protection and Ad- vocacy for Mentally Ill Individuals Act of 1986 20
p.000941: applies shall no- tify the appropriate agency, as determined by the Secretary, of each death that occurs
p.000941: at each such facility while a patient is re- strained or in seclusion, of each death occurring within
p.000941: 24 hours after the patient has been removed from restraints and seclusion,
p.000941:
p.000941:
p.000941:
p.000941:
p.000941: January 30, 2020
p.000941: 20 Probably should be Protection and Advocacy for Individuals with Mental Illness Act. See section 3206(a)
p.000941: of Public Law 106–310 (114 Stat. 1193).
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000941:
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p.000941:
p.000943: 943
p.000943: PUBLIC HEALTH SERVICE ACT
p.000943: Sec. 595
p.000943:
p.000943: or where it is reasonable to assume that a patient’s death is a re- sult of such seclusion or restraint. A notification
p.000943: under this section shall include the name of the resident and shall be provided not later than 7 days
p.000943: after the date of the death of the individual in- volved.
p.000943: (b) FACILITY.—In this section, the term ‘‘facility’’ has the mean- ing given the term ‘‘facilities’’ in section
p.000943: 102(3) of the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10802(3)).
p.000943: SEC. 593. 21 ø290ii–3¿ REGULATIONS AND ENFORCEMENT.
p.000943: (a) TRAINING.—Not later than 1 year after the date of the en- actment of this part, the Secretary,
p.000943: after consultation with appro- priate State and local protection and advocacy organizations, physi- cians,
p.000943: facilities, and other health care professionals and patients, shall promulgate regulations that require
p.000943: facilities to which the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10801 et
p.000943: seq.) applies, to meet the requirements of sub- section (b).
p.000943: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require that—
p.000943: (1) facilities described in subsection (a) ensure that there is an adequate number of qualified professional
p.000943: and supportive staff to evaluate patients, formulate written individualized, comprehensive treatment plans,
p.000943: and to provide active treat- ment measures;
p.000943: (2) appropriate training be provided for the staff of such facilities in the use of restraints and any
p.000943: alternatives to the use of restraints; and
p.000943: (3) such facilities provide complete and accurate notifica- tion of deaths, as required under section 592(a).
p.000943: (c) ENFORCEMENT.—A facility to which this part applies that fails to comply with any requirement of this part,
p.000943: including a fail- ure to provide appropriate training, shall not be eligible for partici- pation in any program
p.000943: supported in whole or in part by funds ap- propriated to any Federal department or agency.
p.000943:
p.000943: PART I—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON- MEDICAL, COMMUNITY-BASED
p.000943: FACILITIES FOR CHILDREN AND YOUTH
p.000943:
p.000943: SEC. 595. ø290jj¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN NON-MEDICAL,
p.000943: COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH.
p.000943: (a) PROTECTION OF RIGHTS.—
...

p.000975: services.
p.000975: (g) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of
p.000975: assisting in the rehabilitation of disabled persons through an integrated program of—
p.000975: (1) medical evaluation and services, and
p.000975: (2) psychological, social, or vocational evaluation and serv- ices,
p.000975: under competent professional supervision, and in the case of which—
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p.000975: January 30, 2020
p.000975: (3) the major portion of the required evaluation and serv- ices is furnished within the facility; and
p.000975: (4) either (A) the facility is operated in connection with a hospital, or (B) all medical and related health
p.000975: services are pre- scribed by, or are under the general direction of, persons li- censed to practice medicine
p.000975: or surgery in the State.
p.000975: (h) The term ‘‘facility for long-term care’’ means a facility (in- cluding an extended care facility)
p.000975: providing in-patient care for con- valescent or chronic disease patients who require skilled nursing care and
p.000975: related medical services—
p.000975: (1) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or tuberculous
p.000975: patients) or is operated in connection with a hospital, or
p.000975: (2) in which such nursing care and medical services are prescribed by, or are performed under the general
p.000975: direction of, persons licensed to practice medicine or surgery in the State.
p.000975: (i) The term ‘‘construction’’ includes construction of new build- ings, expansion, remodeling, and alteration of
p.000975: existing buildings, and initial equipment of any such buildings (including medical transportation facilities)
p.000975: and, in any case in which it will help to provide a service not previously provided in the community, equip-
p.000975: ment of any buildings; including architects’ fees, but excluding the cost of off-site improvements and, except
p.000975: with respect to public health centers, the cost of the acquisition of land.
p.000975: (j) The term ‘‘cost’’ as applied to construction or modernization means the amount found by the Surgeon General
p.000975: to be necessary for construction and modernization respectively, under a project, except that such term, as
p.000975: applied to a project for modernization of a facility for which a grant or loan is to be made from an allotment under
p.000975: section 602(a)(2), does not include any amount found by the Surgeon General to be attributable to expansion of the bed
p.000975: capacity of such facility.
p.000975: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000975:
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p.001137: information technologies.
p.001137: (D) Each quality measure is free of charge to users of such measure.
p.001137: (E) Each quality measure is publicly available on an Internet website.
p.001137: (d) OTHER ACTIVITIES BY THE SECRETARY.—The Secretary may use amounts available under this section to update and
p.001137: test, where applicable, quality measures endorsed by the entity with a contract under section 1890(a) of the
p.001137: Social Security Act or adopted by the Secretary.
p.001137: (e) COORDINATION OF GRANTS.—The Secretary shall ensure that grants or contracts awarded under this section are
p.001137: coordinated with grants and contracts awarded under sections 1139A(5) and 1139B(4)(A) of the Social Security
p.001137: Act.
p.001137: (f) DEVELOPMENT OF OUTCOME MEASURES.—
p.001137: (1) IN GENERAL.—The Secretary shall develop, and periodi- cally update (not less than every 3 years),
p.001137: provider-level out- come measures for hospitals and physicians, as well as other providers as determined
p.001137: appropriate by the Secretary.
p.001137: (2) CATEGORIES OF MEASURES.—The measures developed under this subsection shall include, to the extent
p.001137: determined appropriate by the Secretary—
p.001137: (A) outcome measurement for acute and chronic dis- eases, including, to the extent feasible, the 5 most
p.001137: preva- lent and resource-intensive acute and chronic medical con- ditions; and
p.001137: (B) outcome measurement for primary and preventa- tive care, including, to the extent feasible,
p.001137: measurements that cover provision of such care for distinct patient popu- lations (such as healthy children,
p.001137: chronically ill adults, or infirm elderly individuals).
p.001137: (3) GOALS.—In developing such measures, the Secretary shall seek to—
p.001137: (A) address issues regarding risk adjustment, account- ability, and sample size;
p.001137: (B) include the full scope of services that comprise a cycle of care; and
p.001137: (C) include multiple dimensions.
p.001137: (4) TIMEFRAME.—
p.001137: (A) ACUTE AND CHRONIC DISEASES.—Not later than 24 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(A).
p.001137: (B) PRIMARY AND PREVENTIVE CARE.—Not later than 36 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(B).
p.001137:
p.001137:
p.001137: January 30, 2020 As Amended Through P.L. 116-94,
p.001137: Enacted December 20, 2019
p.001137:
p.001137:
p.001137:
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p.001137:
p.001137:
p.001139: 1139
p.001139: PUBLIC HEALTH SERVICE ACT
p.001139: Sec. 933
p.001139:
p.001139: Subpart II—Health Care Quality Improvement Programs
p.001139:
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p.001215: nominal payments which may be required for the provi- sion of specific services (within the basic health
p.001215: services), ex- cept that such payments may not be required where or in such a manner that they serve (as determined
p.001215: under regulations of the Secretary) as a barrier to the delivery of health services. Such additional nominal
p.001215: payments shall be fixed in accordance with the regulations of the Secretary. If a health maintenance organization
p.001215: offers to its members the opportunity to obtain basic health services through a physician not described in sub-
p.001215: section (b)(3)(A), the organization may require, in addition to payments described in clause (D) of this
p.001215: paragraph, a reason- able deductible to be paid by a member when obtaining a basic health service from such a
p.001215: physician. A health maintenance or- ganization may include a health service, defined as a supple- mental
p.001215: health service by section 1302(2), in the basic health services provided its members for a basic health
p.001215: services pay- ment described in the first sentence. In the case of an entity which before it became a
p.001215: qualified health maintenance organi- zation (within the meaning of section 1310(d)) provided com- prehensive
p.001215: health services on a prepaid basis, the requirement of clause (C) shall not apply to such entity until the expiration
p.001215: of the forty-eight month period beginning with the month fol- lowing the month in which the entity became such
p.001215: a qualified health organization. The requirements of this paragraph re- specting the basic health services
p.001215: payment shall not apply to the provision of basic health services to a member for an ill- ness or
p.001215: injury for which the member is entitled to benefits under a workmen’s compensation law or an insurance
p.001215: policy but only to the extent such benefits apply to such services. For the provision of such services for an illness
p.001215: or injury for which a member is entitled to benefits under such a law, the health maintenance organization
p.001215: may, if authorized by such law, charge or authorize the provider of such services to charge, in accordance
p.001215: with the charges allowed under such law, the insur- ance carrier, employer, or other entity which under such
p.001215: law is to pay for the provision of such services or, to the extent that such member has been paid under such law
p.001215: for such services, such member. For the provision of such services for an illness or injury for which
p.001215: a member is entitled to benefits under an insurance policy, a health maintenance organization may
p.001215: charge or authorize the provider of such services to charge the insurance carrier under such policy or, to the extent
p.001215: that such member has been paid under such policy for such services, such member.
p.001215: (2) For such payment or payments (hereinafter in this title
p.001215: referred to as ‘‘supplemental health services payments’’) as the health maintenance organization may require in
p.001215: addition to the basic health services payment, the organization may pro- vide to each of its members any
p.001215: of the health services which
p.001215: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001215:
p.001215:
p.001215:
p.001215:
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p.001257:
p.001259: 1259
p.001259: PUBLIC HEALTH SERVICE ACT
p.001259: Sec. 1624
p.001259:
p.001259: treatment, under the professional supervision of persons li- censed to practice dentistry in the State; or
p.001259: (C) which offers to patients not requiring hospitaliza- tion the services of licensed physicians in
p.001259: various medical specialties and which provides to its patients a reasonably full range of diagnostic and treatment
p.001259: services.
p.001259: (5) The term ‘‘rehabilitation facility’’ means a facility which is operated for the primary purpose of assisting in the
p.001259: rehabili- tation of disabled persons through an integrated program of—
p.001259: (A) medical evaluation and services, and
p.001259: (B) psychological, social, or vocational evaluation and services,
p.001259: under competent professional supervision, and in the case of which the major portion of the required
p.001259: evaluation and serv- ices is furnished within the facility; and either the facility is operated in
p.001259: connection with a hospital, or all medical and re- lated health services are prescribed by, or are
p.001259: under the gen- eral direction of, persons licensed to practice medicine or sur- gery in the State.
p.001259: (6) The term ‘‘facility for long-term care’’ means a facility (including a skilled nursing or
p.001259: intermediate care facility) pro- viding in-patient care for convalescent or chronic disease pa- tients who
p.001259: required skilled nursing or intermediate care and related medical services—
p.001259: (A) which is a hospital (other than a hospital primarily for the care and treatment of mentally ill or
p.001259: tuberculosis patients) or is operated in connection with a hospital, or
p.001259: (B) in which such care and medical services are pre- scribed by, or are performed under the general direction
p.001259: of, persons licensed to practice medicine or surgery in the State.
p.001259: (7) The term ‘‘construction’’ means construction of new buildings and initial equipment of such buildings
p.001259: and, in any case in which it will help to provide a service not previously provided in the community,
p.001259: equipment of any buildings; in- cluding architects’ fees, but excluding the cost of off-site im-
p.001259: provements and, except with respect to public health centers, the cost of the acquisition of land
p.001259: (8) The term ‘‘cost’’ as applied to construction moderniza- tion, or conversion means the amount found
p.001259: by the Secretary to be necessary for construction, modernization, or conversion, respectively, under a
p.001259: project, except that, in the case of a mod- ernization project or a project assisted under part D, such term does not
p.001259: include any amount found by the Secretary to be at- tributable to expansion of the bed capacity of any
p.001259: facility.
p.001259: (9) The term ‘‘modernization’’ includes the alteration, ex- pansion, major repair (to the extent permitted by
p.001259: regulations), remodeling, replacement, and renovation of existing buildings (including initial equipment
p.001259: thereof), and the replacement of obsolete equipment of existing buildings.
p.001259:
p.001259: January 30, 2020 As Amended Through P.L. 116-94,
p.001259: Enacted December 20, 2019
p.001259:
p.001259:
p.001259:
p.001259:
p.001259:
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p.001287:
p.001287:
p.001287:
p.001287:
p.001287:
p.001287: January 30, 2020
p.001287: USE OF ALLOTMENTS
p.001287: SEC. 1904. ø300w–3¿ (a)(1) Except as provided in subsections
p.001287: (b) and (c), payments made to a State under section 1903 may be used for the following:
p.001287: (A) Activities consistent with making progress toward achieving the objectives established by the
p.001287: Secretary for the health status of the population of the United States for the year 2000 (in this part
p.001287: referred to as ‘‘year 2000 health objec- tives’’).
p.001287: (B) Preventive health service programs for the control of rodents and for community and school-based
p.001287: fluoridation pro- grams.
p.001287: (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and
p.001287: im- provement of such systems. Amounts for such systems may not be used for the costs of the operation of the systems
p.001287: or the pur- chase of equipment for the systems, except that such amounts may be used for the payment of not
p.001287: more than 50 percent of the costs of purchasing communications equipment for the sys- tems. Amounts may be expended
p.001287: for feasibility studies or plan- ning for the trauma-care components of such systems only if the studies or
p.001287: planning, respectively, is consistent with the re- quirements of section 1213(a).
p.001287: (D) Providing services to victims of sex offenses and for prevention of sex offenses.
p.001287: (E) The establishment, operation, and coordination of effec- tive and cost-efficient systems to reduce the
p.001287: prevalence of ill- ness due to asthma and asthma-related illnesses, especially among children, by reducing the
p.001287: level of exposure to cockroach allergen or other known asthma triggers through the use of in- tegrated pest
p.001287: management, as applied to cockroaches or other known allergens. Amounts expended for such systems may in- clude
p.001287: the costs of building maintenance and the costs of pro- grams to promote community participation in the
p.001287: carrying out at such sites of integrated pest management, as applied to
p.001287: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001287:
p.001287:
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p.001287:
p.001287: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1288
p.001287:
p.001287: cockroaches or other known allergens. For purposes of this sub- paragraph, the term ‘‘integrated pest management’’
p.001287: means an approach to the management of pests in public facilities that combines biological, cultural,
p.001287: physical, and chemical tools in a way that minimizes economic, health, and environmental risks.
p.001287: (F) With respect to activities described in any of subpara- graphs (A) through (E), related planning,
p.001287: administration, and educational activities.
p.001287: (G) Monitoring and evaluation of activities carried out under any of subparagraphs (A) through (F).
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p.001305:
p.001305:
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p.001305:
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p.001305:
p.001305: January 30, 2020
p.001305:
p.001305: under clause (ii) for such District to the amount deter- mined under clause (iii).
p.001305: (ii) The amount determined under this clause for the District of Columbia is the quotient of—
p.001305: (I) the most recent 3-year arithmetic mean of total personal income in such District, as determined by the Secretary of
p.001305: Commerce; divided by
p.001305: (II) the factor determined under paragraph (8) for the District.
p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
p.001305: in clause (ii) for the District of Columbia.
p.001305: (7) DETERMINATION OF TERM ‘‘P%’’.—For purposes of para- graph (4), the term ‘‘P%’’ means the percentage
p.001305: constituted by the ratio of the term ‘‘P’’ determined under paragraph (5) for the State involved to the sum
p.001305: of the respective terms ‘‘P’’ deter- mined for the States.
p.001305: (8) DETERMINATION OF CERTAIN FACTOR.—
p.001305: (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to
p.001305: adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under
p.001305: each of sub- paragraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist
p.001305: between the State and other States in the costs of providing comprehensive community mental health services to
p.001305: adults with a serious mental ill- ness and to children with a serious emotional disturbance.
p.001305: (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year
p.001305: in- volved shall be determined according to the methodology described in the report entitled ‘‘Adjusting
p.001305: the Alcohol, Drug Abuse and Mental Health Services Block Grant Allo- cations for Poverty Populations and Cost of
p.001305: Service’’, dated March 30, 1990, and prepared by Health Economics Re- search, a corporation, pursuant to a
p.001305: contract with the Na- tional Institute on Drug Abuse.
p.001305: (C) The factor determined under this paragraph for the State involved may not for any fiscal year be
p.001305: greater than 1.1 or less than 0.9.
p.001305: (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General,
p.001305: shall in accordance with this section make a determination for each State of the factor that is to be in effect
p.001305: for the State under this paragraph. The factor so determined shall re- main in effect through fiscal year 1994,
p.001305: and shall be recal- culated every third fiscal year thereafter.
p.001305: (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the
p.001305: Federal Register, periodically make such refinements in the meth- odology referred to in subparagraph (B) as are
p.001305: consistent with the purpose described in subparagraph (A).
...

p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
p.001361: (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table—
p.001361: (I) received the vaccine in the United States or in its trust territories,
p.001361: (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person
p.001361: was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the
p.001361: United States or a dependent of such a citizen, or
p.001361: (III) received the vaccine outside the United States or a trust territory and the vaccine was manu-
p.001361: factured by a vaccine manufacturer located in the United States and such person returned to the United States
p.001361: not later than 6 months after the date of the vaccination,
p.001361: (ii) if such person did not receive such a vaccine but contracted polio from another person who received an
p.001361: oral polio vaccine, was a citizen of the United States or a de- pendent of such a citizen,
p.001361: (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the
p.001361: Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the
p.001361: administration of such vaccine, and the first symptom or manifestation of the onset or of the significant
p.001361: aggravation of any such ill- ness, disability, injury, or condition or the death occurred within the
p.001361: time period after vaccine administration set forth in the Vaccine Injury Table, or
p.001361: (ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or condition not set
p.001361: forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
p.001361: (II) sustained, or had significantly aggravated, any ill- ness, disability, injury, or condition set forth in
p.001361: the Vac- cine Injury Table the first symptom or manifestation of the onset or significant aggravation of which
p.001361: did not occur within the time period set forth in the Table but which was caused by a vaccine referred
p.001361: to in subparagraph (A), (D)(i) suffered the residual effects or complications of such illness, disability,
p.001361: injury, or condition for more than
p.001361: 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine,
p.001361: or (iii) suf- fered such illness, disability, injury, or condition from the
p.001361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001361:
p.001361:
p.001361:
p.001361:
p.001361:
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p.001361:
p.001361: Sec. 2112 PUBLIC HEALTH SERVICE ACT 1362
p.001361:
p.001361: vaccine which resulted in inpatient hospitalization and surgical intervention, and
p.001361: (E) has not previously collected an award or settle- ment of a civil action for damages for such
p.001361: vaccine-related injury or death,
p.001361: (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records
...

p.001367: (2) The special master or court may find the first symptom or manifestation of onset or significant aggravation
p.001367: of an in- jury, disability, illness, condition, or death described in a peti- tion occurred within the time
p.001367: period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation
p.001367: was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may
p.001367: be made only upon demonstration by a preponderance of the evi- dence that the onset or significant
p.001367: aggravation of the injury, disability, illness, condition, or death described in the petition did in fact
p.001367: occur within the time period described in the Vac- cine Injury Table.
p.001367: (c) RECORD DEFINED.—For purposes of this section, the term ‘‘record’’ means the record established by the
p.001367: special masters of the United States Claims Court in a proceeding on a petition filed under section 2111.
p.001367: VACCINE INJURY TABLE
p.001367: SEC. 2114. ø300aa–14¿ (a) INITIAL TABLE.—The following is a table of vaccines, the injuries, disabilities,
p.001367: illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which
p.001367: the first symptom or manifestation of onset or of the significant aggravation of such injuries,
p.001367: disabilities, ill- nesses, conditions, and deaths is to occur after vaccine administra- tion for purposes of receiving
p.001367: compensation under the Program:
p.001367: VACCINE INJURY TABLE
p.001367: I. DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis
p.001367: Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s).
p.001367:
p.001367: Illness, disability, injury, or condi- tion covered:
p.001367:
p.001367: A. Anaphylaxis or anaphylactic
p.001367: Time period for first symptom or manifestation of onset or of sig- nificant aggravation after vaccine
p.001367: administration:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367:
p.001367: January 30, 2020
p.001367: shock 24 hours
p.001367: B. Encephalopathy (or encephalitis) 3 days
p.001367: C. Shock-collapse or hypotonic- hyporesponsive collapse 3 days
p.001367: D. Residual seizure disorder in ac-
p.001367: cordance with subsection (b)(2) 3 days
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
p.001367:
p.001367:
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p.001367:
p.001367:
p.001369: 1369
p.001369: PUBLIC HEALTH SERVICE ACT
p.001369: Sec. 2114
p.001369:
p.001369: E. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: II. Measles, mumps, rubella, or any vaccine containing any of the fore- going as a component;
p.001369: DT; Td; or Tetanus Toxoid.
p.001369: A. Anaphylaxis or anaphylactic
p.001369: shock 24 hours
p.001369: B. Encephalopathy (or encephalitis) 15 days (for mumps, rubella, mea-
p.001369: sles, or any vaccine containing any of the foregoing as a compo- nent). 3 days (for DT, Td, or
p.001369: tet- anus toxoid).
p.001369: C. Residual seizure disorder in ac-
p.001369: cordance with subsection (b)(2) .... 15 days (for mumps, rubella, mea-
p.001369: sles, or any vaccine containing any of the foregoing as a compo- nent). 3 days (for DT, Td, or
p.001369: tet- anus toxoid).
p.001369:
p.001369:
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p.001369:
p.001369:
p.001369: January 30, 2020
p.001369: D. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: III. Polio Vaccines (other than Inac- tivated Polio Vaccine).
p.001369: A. Paralytic polio
p.001369: —in a non-immunodeficient re-
p.001369: cipient 30 days
p.001369: —in an immunodeficient recipient 6 months
p.001369: —in a vaccine-associated commu-
p.001369: nity case Not applicable
p.001369: B. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: IV. Inactivated Polio Vaccine.
p.001369: A. Anaphylaxis or anaphylactic
p.001369: shock 24 hours
p.001369: B. Any acute complication or se- quela (including death) of an ill- ness, disability, injury, or
p.001369: condi- tion referred to above which ill- ness, disability, injury, or condi- tion arose within the time
p.001369: period
p.001369: prescribed Not applicable
p.001369: (b) QUALIFICATIONS AND AIDS TO INTERPRETATION.—The fol- lowing qualifications and aids to interpretation
p.001369: shall apply to the Vaccine Injury Table in subsection (a):
p.001369: (1) A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as
p.001369: decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning
p.001369: pale white or blue, un- responsiveness to environmental stimuli, depression of con-
p.001369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001369:
p.001369:
p.001369:
p.001369:
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p.001369:
p.001369:
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p.001369:
p.001369: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1370
p.001369: sciousness, loss of consciousness, prolonged sleeping with dif- ficulty arousing, or cardiovascular or
p.001369: respiratory arrest.
p.001369: (2) A petitioner may be considered to have suffered a resid- ual seizure disorder if the petitioner did not suffer a
p.001369: seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit
p.001369: before the first seizure or convulsion after the administration of the vaccine involved and if—
p.001369:
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p.001585: representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining
p.001585: agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment
p.001585: made by subsection
p.001585: (a) shall not be treated as a termination of such collective bargaining agreement.’’.
p.001585: The Public Law was enacted October 21, 1998.
p.001585: 13 So in law.
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
p.001585:
p.001585:
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p.001585:
p.001585:
p.001585: C:\XML\SSA-MERGED.XML
p.001585:
p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
p.001585:
p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
...

Health / injured

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p.000225: January 30, 2020
p.000225:
p.000225: bility of a defendant for the harm to the plaintiff. For purposes of this paragraph, the term ‘‘noneconomic
p.000225: damages’’ means damages for losses for physical and emotional pain, suffering, inconvenience, physical
p.000225: impairment, mental anguish, disfigure- ment, loss of enjoyment of life, loss of society and companion- ship,
p.000225: loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
p.000225: (9) RULE 11 SANCTIONS.—Whenever a district court of the United States determines that there has been a
p.000225: violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court
p.000225: shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are respon- sible for
p.000225: the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the
p.000225: reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that
p.000225: is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter
p.000225: repetition of such conduct or comparable conduct by others similarly situated, and to compensate the
p.000225: party or parties injured by such conduct.
p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
p.000225: right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law
p.000225: or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United
p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
p.000225: section, or any amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed
...

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p.000229: January 30, 2020
p.000229: ‘‘Covered Countermeasure Process Fund’’ for purposes of providing timely, uniform, and adequate compensation to
p.000229: eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure
p.000229: pursuant to such declaration, which Fund shall consist of such amounts designated as emergency ap-
p.000229: propriations under section 402 of H. Con. Res. 95 of the 109th Con- gress, this emergency designation shall remain
p.000229: in effect through October 1, 2006.
p.000229: (b) PAYMENT OF COMPENSATION.—
p.000229: (1) IN GENERAL.—If the Secretary issues a declaration under 319F–3(b), the Secretary shall, after amounts
p.000229: have by law been provided for the Fund under subsection (a), provide compensation to an eligible
p.000229: individual for a covered injury di- rectly caused by the administration or use of a covered coun-
p.000229: termeasure pursuant to such declaration.
p.000229: (2) ELEMENTS OF COMPENSATION.—The compensation that shall be provided pursuant to paragraph (1) shall
p.000229: have the same elements, and be in the same amount, as is prescribed by sections 264, 265, and 266 in the
p.000229: case of certain individuals injured as a result of administration of certain counter- measures against
p.000229: smallpox, except that section 266(a)(2)(B) shall not apply.
p.000229: (3) RULE OF CONSTRUCTION.—Neither reasonable and nec- essary medical benefits nor lifetime total benefits
p.000229: for lost em- ployment income due to permanent and total disability shall be limited by section 266.
p.000229: (4) DETERMINATION OF ELIGIBILITY AND COMPENSATION.— Except as provided in this section, the procedures
p.000229: for deter- mining, and for reviewing a determination of, whether an indi- vidual is an eligible individual,
p.000229: whether such individual has sustained a covered injury, whether compensation may be available under
p.000229: this section, and the amount of such com- pensation shall be those stated in section 262 (other than
p.000229: in subsection (d)(2) of such section), in regulations issued pursu- ant to that section, and in such additional
p.000229: or alternate regula- tions as the Secretary may promulgate for purposes of this sec- tion. In making determinations
p.000229: under this section, other than those described in paragraph (5)(A) as to the direct causation of a
p.000229: covered injury, the Secretary may only make such deter- mination based on compelling, reliable, valid, medical
p.000229: and sci- entific evidence.
p.000229: (5) COVERED COUNTERMEASURE INJURY TABLE.—
p.000229: (A) IN GENERAL.—The Secretary shall by regulation establish a table identifying covered injuries that
p.000229: shall be presumed to be directly caused by the administration or use of a covered countermeasure and the
p.000229: time period in which the first symptom or manifestation of onset of each such adverse effect must manifest in
...

p.001179: (b) GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS.—The Secretary may make grants, and enter into cooperative
p.001179: agreements and contracts, for the purpose of carrying out subsection (a).
p.001179: SEC. 1202. ø300d–3¿ ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE IN RURAL AREAS.
p.001179: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001179: of carrying out re- search and demonstration projects with respect to improving the availability and
p.001179: quality of emergency medical services in rural areas—
p.001179:
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p.001179:
p.001179: January 30, 2020
p.001179: (1) by developing innovative uses of communications tech- nologies and the use of new communications technology;
p.001179: (2) by developing model curricula, such as advanced trau- ma life support, for training emergency medical
p.001179: services per- sonnel, including first responders, emergency medical techni- cians, emergency nurses and
p.001179: physicians, and paramedics—
p.001179: (A) in the assessment, stabilization, treatment, prepa- ration for transport, and resuscitation of seriously
p.001179: injured patients, with special attention to problems that arise dur- ing long transports and to methods of
p.001179: minimizing delays in transport to the appropriate facility; and
p.001179: (B) in the management of the operation of the emer- gency medical services system;
p.001179: (3) by making training for original certification, and con- tinuing education, in the provision and
p.001179: management of emer- gency medical services more accessible to emergency medical personnel in rural areas
p.001179: through telecommunications, home studies, providing teachers and training at locations accessible to such personnel,
p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001179:
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: January 30, 2020
p.001179:
p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
p.001179: (6) by increasing communication and coordination with State trauma systems.
p.001179: (b) SPECIAL CONSIDERATION FOR CERTAIN RURAL AREAS.—In making grants under subsection (a), the
p.001179: Secretary shall give spe- cial consideration to any applicant for the grant that will provide services
p.001179: under the grant in any rural area identified by a State under section 1214(d)(1).
p.001179: (c) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.001179: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001179: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
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p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001179:
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p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001181: January 30, 2020
p.001181: (d) PRIORITY.—In making grants under this section, the Sec- retary shall give priority to applicants that
p.001181: will use the grants to focus on improving access to trauma care systems.
p.001181: (e) SPECIAL CONSIDERATION.—In awarding grants under this section, the Secretary shall give special
...

p.001185: PUBLIC HEALTH SERVICE ACT
p.001185: Sec. 1213
p.001185:
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p.001185: January 30, 2020
p.001185: ties and expertise in the care of pediatric trauma patients), by such entity, including standards and requirements for—
p.001185: (A) the number and types of trauma patients for whom such centers must provide care in order to ensure that
p.001185: such centers will have sufficient experience and expertise to be able to provide quality care for victims of
p.001185: injury;
p.001185: (B) the resources and equipment needed by such cen- ters; and
p.001185: (C) the availability of rehabilitation services for trau- ma patients;
p.001185: (4) contains standards and requirements for the implemen- tation of regional trauma care systems, including
p.001185: standards and guidelines (consistent with the provisions of section 1867 of the Social Security Act) for
p.001185: medically directed triage and transportation of trauma patients (including patients injured in rural areas)
p.001185: prior to care in designated trauma centers;
p.001185: (5) subject to subsection (b), contains national standards and requirements, including those of the American
p.001185: Academy of Pediatrics and the American College of Emergency Physicians, for medically directed triage and
p.001185: transport of severely injured children to designated trauma centers with specified capabili- ties and
p.001185: expertise in the care of pediatric trauma patients;
p.001185: (6) utilizes a program with procedures for the evaluation of designated trauma centers (including trauma
p.001185: centers de- scribed in paragraph (5)) and trauma care systems;
p.001185: (7) provides for the establishment and collection of data in accordance with data collection requirements developed in
p.001185: con- sultation with surgical, medical, and nursing specialty groups, State and local emergency medical services
p.001185: directors, and other trained professionals in trauma care, from each designated trauma center in the State
p.001185: of a central data reporting and analysis system—
p.001185: (A) to identify the number of severely injured trauma patients and the number of deaths from trauma
p.001185: within trauma care systems in the State;
p.001185: (B) to identify the cause of the injury and any factors contributing to the injury;
p.001185: (C) to identify the nature and severity of the injury;
p.001185: (D) to monitor trauma patient care (including prehospital care) in each designated trauma center
p.001185: within regional trauma care systems in the State (including rel- evant emergency-department discharges and
p.001185: rehabilitation information) for the purpose of evaluating the diagnosis, treatment, and treatment outcome of
p.001185: such trauma pa- tients;
p.001185: (E) to identify the total amount of uncompensated trauma care expenditures for each fiscal year by each des-
p.001185: ignated trauma center in the State; and
p.001185: (F) to identify patients transferred within a regional trauma system, including reasons for such transfer
p.001185: and the outcomes of such patients;
p.001185: (8) provides for the use of procedures by paramedics and emergency medical technicians to assess the severity
...

p.001185: ferred to designated trauma centers, and to provide periodic re- views of the transfers and the auditing of
p.001185: such transfers that are determined to be appropriate;
p.001185: (10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
p.001185: (11) coordinates planning for trauma systems with State disaster emergency planning and bioterrorism
p.001185: hospital pre- paredness planning; and
p.001185: (12) with respect to the requirements established in this subsection, provides for coordination and
p.001185: cooperation between the State and any other State with which the State shares any standard metropolitan statistical
p.001185: area.
p.001185: (b) CERTAIN STANDARDS WITH RESPECT TO TRAUMA CARE CEN-
p.001185: TERS AND SYSTEMS.—
p.001185: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) for a fiscal year unless the
p.001185: State in- volved agrees that, in carrying out paragraphs (3) through (5) of subsection (a), the State
p.001185: will adopt standards for the des- ignation of trauma centers, and for triage, transfer, and trans- portation
p.001185: policies, and that the State will, in adopting such standards—
p.001185: (A) take into account national standards that outline resources for optimal care of injured patients;
p.001185: (B) consult with medical, surgical, and nursing spe- ciality groups, hospital associations, emergency
p.001185: medical services State and local directors, concerned advocates, and other interested parties;
p.001185: (C) conduct hearings on the proposed standards after providing adequate notice to the public concerning
p.001185: such hearing; and
p.001185: (D) beginning in fiscal year 2008, take into account the model plan described in subsection (c).
p.001185: (2) QUALITY OF TRAUMA CARE.—The highest quality of trauma care shall be the primary goal of State
p.001185: standards adopted under this subsection.
p.001185: (3) APPROVAL BY THE SECRETARY.—The Secretary may not make payments under section 1211(a) to a State if
p.001185: the Sec- retary determines that—
p.001185: (A) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not taken
p.001185: into ac- count national standards, including those of the American College of Surgeons, the American College of
p.001185: Emergency Physicians, and the American Academy of Pediatrics, in adopting standards under this subsection; or
p.001185: (B) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not, in
p.001185: adopting such standards, taken into account the model plan devel- oped under subsection (c).
p.001185: (c) MODEL TRAUMA CARE PLAN.—
p.001185: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001185:
p.001185:
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p.001185:
p.001185:
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p.001191: access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and
p.001191: rehabilitation of patients of all ages with respect to emergency medical services.
p.001191: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.001191: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001191: (4) TRAUMA.—The term ‘‘trauma’’ means an injury result- ing from exposure to—
p.001191: (A) a mechanical force; or
p.001191: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001191: radioactive.
p.001191: (5) TRAUMA CARE COMPONENT OF STATE PLAN.—The term ‘‘trauma care component’’, with respect to components
p.001191: of the State plan for the provision of emergency medical services, means a plan for a comprehensive
p.001191: health care system, within rural and urban areas of the State, for the prompt recognition, prehospital care,
p.001191: emergency medical care, acute surgical and medical care, rehabilitation, and outcome evaluation of seri-
p.001191: ously injured patients.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001191:
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p.001191: Sec. 1232 PUBLIC HEALTH SERVICE ACT 1192
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p.001191: January 30, 2020
p.001191:
p.001191: SEC. 1232. ø300d–32¿ FUNDING.
p.001191: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out parts A and B, subject to subsections (b)
p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
p.001191: appropriated is greater than
p.001191: $1,000,000, 50 percent of such appropriation shall be made avail- able for the purpose of carrying out part A
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p.001381: 1381
p.001381: PUBLIC HEALTH SERVICE ACT
p.001381: Sec. 2123
p.001381:
p.001381: erly prepared and was accompanied by proper directions and warnings.
p.001381: (2) For purposes of paragraph (1), a vaccine shall be pre- sumed to be accompanied by proper directions and
p.001381: warnings if the vaccine manufacturer shows that it complied in all mate- rial respects with all
p.001381: requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service
p.001381: Act (including regulations issued under such provi- sions) applicable to the vaccine and related to
p.001381: vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
p.001381: (A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section
p.001381: 2123(d)(2), or
p.001381: (B) by clear and convincing evidence that the manufac- turer failed to exercise due care notwithstanding its
p.001381: com- pliance with such Act and section (and regulations issued under such provisions).
p.001381: (c) DIRECT WARNINGS.—No vaccine manufacturer shall be lia- ble in a civil action for damages arising
p.001381: from a vaccine-related in- jury or death associated with the administration of a vaccine after the effective date
p.001381: of this part 24 solely due to the manufacturer’s failure to provide direct warnings to the injured
p.001381: party (or the in- jured party’s legal representative) of the potential dangers result- ing from the
p.001381: administration of the vaccine manufactured by the manufacturer.
p.001381: (d) CONSTRUCTION.—The standards of responsibility prescribed by this section are not to be construed as authorizing a
p.001381: person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in
p.001381: which damages were denied or which was dismissed with prejudice to bring a new civil action against such
p.001381: manufacturer for such injury or death.
p.001381: (e) PREEMPTION.—No State may establish or enforce a law which prohibits an individual from bringing a
p.001381: civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is
p.001381: not barred by this subtitle.
p.001381: TRIAL
p.001381: SEC. 2123. ø300aa–23¿ (a) GENERAL RULE.—A civil action against a vaccine manufacturer for damages
p.001381: for a vaccine-related injury or death associated with the administration of a vaccine after the effective
p.001381: date of this part 24 which is not barred by section 2111(a)(2) shall be tried in three stages.
p.001381: (b) LIABILITY.—The first stage of such a civil action shall be held to determine if a vaccine manufacturer is
p.001381: liable under section 2122.
p.001381: (c) GENERAL DAMAGES.—The second stage of such a civil action shall be held to determine the amount of damages (other
p.001381: than pu- nitive damages) a vaccine manufacturer found to be liable under section 2122 shall be required to
p.001381: pay.
p.001381: (d) PUNITIVE DAMAGES.—
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p.000001: 2 So in law. See section 2008(g)(2) of Public Law 103–43 (107 Stat. 212). The term ‘‘the Agen- cy’’ probably should
p.000001: be preceded by ‘‘(5)’’, and the ‘‘and’’ before ‘‘(4)’’ probably should be struck. Further, Public Law
p.000001: 106–129 redesignated the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality
p.000001: (see 113 Stat. 1653).
p.000001: 3 Civil service and classification laws are now codified to title 5, United States Code.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
p.000001: Sec. 203A PUBLIC HEALTH SERVICE ACT 4
p.000001:
p.000001: active duty shall be deemed to be commissioned officers of the Reg- ular Corps.
p.000001: (c) PURPOSE AND USE OF READY RESEARCH.—
p.000001: (1) PURPOSE.—The purpose of the Ready Reserve Corps is to fulfill the need to have additional Commissioned
p.000001: Corps per- sonnel available on short notice (similar to the uniformed serv- ice’s reserve program) to assist
p.000001: regular Commissioned Corps personnel to meet both routine public health and emergency response missions.
p.000001: (2) USES.—The Ready Reserve Corps shall—
p.000001: (A) participate in routine training to meet the general and specific needs of the Commissioned Corps;
p.000001: (B) be available and ready for involuntary calls to ac- tive duty during national emergencies and public
p.000001: health crises, similar to the uniformed service reserve personnel;
p.000001: (C) be available for backfilling critical positions left va- cant during deployment of active duty
p.000001: Commissioned Corps members, as well as for deployment to respond to public health emergencies, both foreign
p.000001: and domestic; and
p.000001: (D) be available for service assignment in isolated, hardship, and medically underserved communities (as
p.000001: de- fined in section 799B) to improve access to health services.
p.000001: (d) FUNDING.—For the purpose of carrying out the duties and responsibilities of the Commissioned Corps
p.000001: under this section, there are authorized to be appropriated $5,000,000 for each of fis- cal years
p.000001: 2010 through 2014 for recruitment and training and
p.000001: $12,500,000 for each of fiscal years 2010 through 2014 for the Ready Reserve Corps.
p.000001: SEC. 203A. ø204a¿ DEPLOYMENT READINESS.
p.000001: (a) READINESS REQUIREMENTS FOR COMMISSIONED CORPS OFFI-
p.000001: CERS.—
p.000001:
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p.000001: January 30, 2020
p.000001: (1) IN GENERAL.—The Secretary, with respect to members of the following Corps components, shall establish
p.000001: require- ments, including training and medical examinations, to ensure the readiness of such components to
p.000001: respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State,
p.000001: and local levels:
p.000001: (A) Active duty Regular Corps.
p.000001: (B) Active Reserves.
p.000001: (2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary shall annually determine whether each member of the
p.000001: Corps meets the applicable readiness requirements established under paragraph (1).
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p.000001: established by the Secretary, be subject to disciplinary action as prescribed by the Secretary.
p.000001: (4) WAIVER OF REQUIREMENTS.—
p.000001: (A) IN GENERAL.—The Secretary may waive one or more of the requirements established under paragraph (1)
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
p.000001: 5 PUBLIC HEALTH SERVICE ACT Sec. 203A
p.000001:
p.000001: for an individual who is not able to meet such require- ments because of—
p.000001: (i) a disability;
p.000001: (ii) a temporary medical condition; or
p.000001: (iii) any other extraordinary limitation as deter- mined by the Secretary.
p.000001: (B) REGULATIONS.—The Secretary shall promulgate regulations under which a waiver described in subpara-
p.000001: graph (A) may be granted.
p.000001: (5) URGENT OR EMERGENCY PUBLIC HEALTH CARE NEED.— For purposes of this section and section 214, the term
p.000001: ‘‘urgent or emergency public health care need’’ means a health care need, as determined by the Secretary,
p.000001: arising as the result of—
p.000001: (A) a national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et
p.000001: seq.);
p.000001: (B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and
p.000001: Emergency Assistance Act (42 U.S.C. 5121 et seq.);
p.000001: (C) a public health emergency declared by the Sec- retary under section 319 of this Act; or
p.000001: (D) any emergency that, in the judgment of the Sec- retary, is appropriate for the deployment of
p.000001: members of the Corps.
p.000001: (b) CORPS MANAGEMENT FOR DEPLOYMENT.—The Secretary shall—
p.000001: (1) organize members of the Corps into units for rapid de-
p.000001: ployment by the Secretary to respond to urgent or emergency public health care needs;
p.000001: (2) establish appropriate procedures for the command and control of units or individual members of the
p.000001: Corps that are deployed at the direction of the President or the Secretary in response to an urgent or
p.000001: emergency public health care need of national, State or local significance;
p.000001: (3) ensure that members of the Corps are trained, equipped and otherwise prepared to fulfill
p.000001: their public health and emergency response roles; and
p.000001: (4) ensure that deployment planning takes into account—
p.000001: (A) any deployment exemptions that may be granted by the Secretary based on the unique requirements of
...

p.000001: than
p.000001: 90 days (as determined by the Secretary) of the public health emergency determination (excluding any period
p.000001: cov- ered by a renewal of such determination); or
p.000001: (B) to a major disaster or an emergency as declared by the President under section 401 of the Robert T.
p.000001: Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 225 PUBLIC HEALTH SERVICE ACT 44
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p.000001: January 30, 2020
p.000001:
p.000001: 5170) or under section 201 of the National Emergencies Act (50 U.S.C. 1621) during the initial period of such
p.000001: dec- laration;
p.000001: (2) is alleged to be liable for an act or omission—
p.000001: (A) during the initial period of a determination or dec- laration described in paragraph (1) and related to the
p.000001: treatment of individuals in need of health care services due to such public health emergency, major
p.000001: disaster, or emergency;
p.000001: (B) in the State or States for which such determina- tion or declaration is made;
p.000001: (C) in the health care professional’s capacity as a member of the Medical Reserve Corps or a professional in-
p.000001: cluded in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I;
p.000001: and
p.000001: (D) in the course of providing services that are within the scope of the license, registration, or certification of the
p.000001: professional, as defined by the State of licensure, registra- tion, or certification; and
p.000001: (3) prior to the rendering of such act or omission, was au- thorized by the State’s authorization of deploying
p.000001: such State’s Emergency System for Advance Registration of Volunteer Health Professionals described in
p.000001: section 319I or the Medical Reserve Corps established under section 2813, to provide health care
p.000001: services,
...

p.000017: IN GENERAL
p.000017: SEC. 311. ø243¿ (a) The Secretary is authorized to accept from State and local authorities any assistance in the
p.000017: enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and
p.000017: willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and
p.000017: suppression of communicable diseases and with respect to other public health matters, shall cooperate with and
p.000017: aid State and local authorities in the enforcement of their quarantine and other health regulations, and
p.000017: shall advise the several States on matters relating to the preservation and improvement of the public health.
p.000017: (b) The Secretary shall encourage cooperative activities be- tween the States with respect to
p.000017: comprehensive and continuing planning as to their current and future health needs, the establish- ment and
p.000017: maintenance of adequate public health services, and oth- erwise carrying out the public health activities. The
p.000017: Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private
p.000017: entities reasonable fees for the training of their personnel under the preceding sentence.
p.000017: (c)(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a
p.000017: plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies
p.000017: under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or con- dition
p.000017: and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the
p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
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p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
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p.000121: subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall
p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
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p.000121: January 30, 2020
p.000121: LOAN REPAYMENT PROGRAM
p.000121: SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
p.000121: (1) AUTHORITY.—Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with
p.000121: appro- priately qualified health professionals under which such health professionals agree to conduct prevention
p.000121: activities or pre- paredness and response activities, including rapid response to public health
p.000121: emergencies and significant public health threats, as employees of the Centers for Disease Control
p.000121: and Prevention and the Agency for Toxic Substances and Disease
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000123: PUBLIC HEALTH SERVICE ACT
p.000123: Sec. 317H
p.000123:
p.000123: Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than
p.000123: $50,000 of the principal and interest of the educational loans of such health professionals.
p.000123: (2) LIMITATION.—The Secretary may not enter into an agreement with a health professional pursuant to
p.000123: paragraph
p.000123: (1) unless such professional—
p.000123: (A) has a substantial amount of educational loans rel- ative to income; and
p.000123: (B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for
p.000123: Toxic Substances and Disease Registry for purposes of para- graph (1) for a period of not less than 2 years.
p.000123: (b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan
p.000123: Repayment Program es- tablished in subpart III of part D of title III of this Act, the provi- sions of such
p.000123: subpart shall, except as inconsistent with subsection (a), apply to the program established in this
...

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p.000145: PUBLIC HEALTH SERVICE ACT
p.000145: Sec. 317U
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p.000145: January 30, 2020
p.000145: ties, parishes, and boroughs. If State law recognizes an entity of general government that functions in
p.000145: lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the
p.000145: jurisdiction of such other entities of general government as a political subdivision for purposes of this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000145: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000145: $100,000,000 for each of fiscal years 2019 through 2023.
p.000145: (2) PUBLIC HEALTH EMERGENCIES.—In the case of control programs carried out in response to a
p.000145: mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under
p.000145: paragraph (1) is in addition to applica- ble authorizations of appropriations under this Act and other medical
p.000145: and public health preparedness and response laws.
p.000145: (3) FISCAL YEAR 2019 APPROPRIATIONS.—For fiscal year 2019, 50 percent or more of the funds appropriated
p.000145: under para- graph (1) shall be used to award grants to political subdivi- sions or consortia of political
p.000145: subdivisions under subsection (b).
p.000145: SEC. 317T. ø247b–22¿ MICROBICIDE RESEARCH.
p.000145: (a) IN GENERAL.—The Director of the Centers for Disease Con- trol and Prevention is strongly encouraged to fully
p.000145: implement the Centers’ microbicide agenda to support research and development of microbicides for use to
p.000145: prevent the transmission of the human immunodeficiency virus.
p.000145: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for each
p.000145: of fiscal years 2009 through 2013 to carry out this section.
p.000145: SEC. 317U. ø???¿ NATIONAL STRATEGY AND REGIONAL CENTERS OF EXCELLENCE IN VECTOR-BORNE DISEASES.
p.000145: (a) IN GENERAL.—The Secretary shall—
p.000145: (1)(A) ensure the development and implementation of a na- tional strategy to address vector-borne diseases, including
p.000145: tick- borne diseases, that—
p.000145: (i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
...

p.000151: appro-
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p.000153: PUBLIC HEALTH SERVICE ACT
p.000153: Sec. 319
p.000153:
p.000153: priated such sums as may be necessary for each of the fiscal years 1993 through 1998.
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p.000153: January 30, 2020
p.000153: DATA COLLECTION REGARDING PROGRAMS UNDER TITLE XXVI
p.000153: SEC. 318B. ø247c–2¿ For the purpose of collecting and pro- viding data for program planning and
p.000153: evaluation activities under title XXVI, there are authorized to be appropriated to the Secretary (acting through the
p.000153: Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the
p.000153: fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of
p.000153: appropriations that are avail- able for such purpose.
p.000153: SEC. 319. ø247d¿ PUBLIC HEALTH EMERGENCIES.
p.000153: (a) EMERGENCIES.—If the Secretary determines, after consulta- tion with such public health officials as may be
p.000153: necessary, that—
p.000153: (1) a disease or disorder presents a public health emer- gency; or
p.000153: (2) a public health emergency, including significant out- breaks of infectious diseases or bioterrorist
p.000153: attacks, otherwise exists,
p.000153: the Secretary may take such action as may be appropriate to re- spond to the public health emergency,
p.000153: including making grants, providing awards for expenses, and entering into contracts and con- ducting and supporting
p.000153: investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs
p.000153: (1) and (2). Any such determination of a public health emergency ter- minates upon the Secretary declaring that the
p.000153: emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the
p.000153: determination is made by the Secretary, which- ever occurs first. Determinations that terminate under the pre-
p.000153: ceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and
p.000153: the preceding sentence applies to each such renewal. Not later than 48 hours after making a de-
p.000153: termination under this subsection of a public health emergency (in- cluding a renewal), the Secretary shall
p.000153: submit to the Congress written notification of the determination.
...

p.000153: provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appro-
p.000153: priations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the
p.000153: House of Representatives on policies to improve such Fund for the uses described in paragraph (2).
p.000153: (5) GAO REPORT.—Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.000153: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000155: PUBLIC HEALTH SERVICE ACT
p.000155: Sec. 319
p.000155:
p.000155: Advancing Innovation Act of 2019, the Comptroller General of the United States shall—
p.000155: (A) conduct a review of the Fund under this section, including its uses and the resources available in the
p.000155: Fund; and
p.000155: (B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee
p.000155: on Energy and Commerce of the House of Representatives a report on such review, including recommendations
p.000155: related to such review, as applicable.
p.000155: (c) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this section shall be used to rapidly respond to public
p.000155: health emer- gencies or potential public health emergencies and supplement and not supplant other Federal, State,
p.000155: and local public funds provided for activities under this Act or funds otherwise provided for emer- gency
p.000155: response.
p.000155: (d) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or partially
p.000155: as a re- sult of a public health emergency that has been determined pursu- ant to subsection (a), individuals or
p.000155: public or private entities are unable to comply with deadlines for the submission to the Sec- retary of
p.000155: data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any
p.000155: other provi- sion of law, grant such extensions of such deadlines as the cir- cumstances reasonably require,
p.000155: and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly
p.000155: after granting such an extension or waiver, the Sec- retary shall notify the Congress of such action
p.000155: and publish in the Federal Register a notice of the extension or waiver.
p.000155: (e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PER-
p.000155: SONNEL DURING A PUBLIC HEALTH EMERGENCY.—
p.000155: (1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PER- SONNEL.—Notwithstanding any other provision of law,
p.000155: and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such
p.000155: Governor or tribal orga- nization’s designee, the Secretary may authorize the requesting State or Indian tribe to
...

p.000157: per- sonnel eligible for reassignment pursuant to an authoriza- tion under paragraph (1) agree to such reassignment.
p.000157: (4) NOTICE TO CONGRESS.—The Secretary shall give notice to the Congress in conjunction with the
p.000157: approval under this subsection of—
p.000157: (A) any initial request for temporary reassignment of personnel; and
p.000157: (B) any request for an extension of such temporary re- assignment.
p.000157: (5) GUIDANCE.—The Secretary shall—
p.000157: (A) not later than 6 months after the enactment of this subsection, issue proposed guidance on the temporary re-
p.000157: assignment of personnel under this subsection; and
p.000157: (B) after providing notice and a 60-day period for pub- lic comment, finalize such guidance.
p.000157: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Prepared-
p.000157: ness Reauthorization Act of 2013, the Comptroller General of the United States shall conduct an
p.000157: independent evaluation, and submit to the appropriate committees of the Congress a re- port, on temporary reassignment
p.000157: under this subsection, includ- ing—
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p.000157: (A) a description of how, and under what cir- cumstances, such temporary reassignment has been
p.000157: used by States and Indian tribes;
p.000157: (B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to pub-
p.000157: lic health emergencies;
p.000157: (C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to pub- lic
p.000157: health emergencies;
p.000157: (D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily re-
p.000157: assigned have been adversely affected by the reassign- ment; and
p.000157: (E) recommendations on how medical surge capacity could be improved in responding to public health emer-
p.000157: gencies and the impact of the reassignment flexibility under this section on such surge capacity.
p.000157: (7) DEFINITIONS.—In this subsection—
p.000157: (A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of
p.000157: the In-
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p.000157: Sec. 319 PUBLIC HEALTH SERVICE ACT 158
p.000157: dian Self-Determination and Education Assistance Act; and
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p.000159: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 160
p.000159:
p.000159: (d) GUIDELINES.—The Secretary, in order to maintain the con- fidentiality of relevant information and ensure that none
p.000159: of the in- formation contained in the systems involved may be used to pro- vide proprietary advantage within
p.000159: the vaccine market, while allow- ing State, local, and tribal health officials access to such informa- tion
p.000159: to maximize the delivery and availability of vaccines to high priority populations, during times of
p.000159: influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufac- turers,
p.000159: distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a)
p.000159: and (b).
p.000159: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000159: $30,800,000 for each of fiscal years 2019 through 2023.
p.000159: (f) REPORT TO CONGRESS.—As part of the National Health Se- curity Strategy described in section 2802,
p.000159: the Secretary shall pro- vide an update on the implementation of subsections (a) through (d).
p.000159: SEC. 319C–1. ø247d–3a¿ IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. 17
p.000159: (a) IN GENERAL.—To enhance the security of the United States with respect to public health emergencies, the
p.000159: Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, shall award
p.000159: cooperative agreements to eligible entities to enable such entities to conduct the activities described in
p.000159: sub- section (d).
p.000159: (b) ELIGIBLE ENTITIES.—To be eligible to receive an award under subsection (a), an entity shall—
p.000159: (1)(A) be a State;
p.000159: (B) be a political subdivision determined by the Secretary to be eligible for an award under this section
p.000159: (based on criteria described in subsection (h)(4)); or
p.000159: (C) be a consortium of States; and
p.000159: (2) prepare and submit to the Secretary an application at such time, and in such manner, and containing
p.000159: such informa- tion as the Secretary may require, including—
p.000159: (A) an All-Hazards Public Health Emergency Pre- paredness and Response Plan which shall include—
p.000159: (i) a description of the activities such entity will carry out under the agreement to meet the goals iden-
p.000159: tified under section 2802, including with respect to chemical, biological, radiological, or nuclear
p.000159: threats, whether naturally occurring, unintentional, or delib- erate;
p.000159: (ii) a description of the activities such entity will carry out with respect to pandemic influenza, as
p.000159: a component of the activities carried out under clause (i), and consistent with the requirements of
p.000159: para- graphs (2) and (5) of subsection (g);
p.000159: (iii) preparedness and response strategies and ca- pabilities that take into account the medical and pub-
p.000159:
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p.000167: data collected by the Bureau of the Census).
p.000167: (D) MINIMUM AMOUNT.—Subject to the amount appro- priated under paragraph (1)(A), an award pursuant to sub-
p.000167: paragraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or
p.000167: the min- imum amount under this subparagraph. The minimum amount under this subparagraph is—
p.000167: (i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puer- to
p.000167: Rico, an amount equal to the lesser of—
p.000167: (I) $5,000,000; or
p.000167: (II) if the amount appropriated under para- graph (1)(A) is less than $667,000,000, an amount equal to 0.75
p.000167: percent of the amount appropriated under such paragraph, less the amount, if any, re- served by the Secretary under
p.000167: paragraphs (4) and (5); or
p.000167: (ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the
p.000167: Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not
p.000167: exceed the amount determined under clause (i).
p.000167: (4) CERTAIN POLITICAL SUBDIVISIONS.—
p.000167: (A) IN GENERAL.—For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such
p.000167: year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec-
p.000167: essary by the Secretary to make awards under subsection
p.000167: (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for
p.000167: re- sponding to public health emergencies, and face a high de- gree of risk from bioterrorist attacks or other public
p.000167: health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.
p.000167: (B) COORDINATION WITH STATEWIDE PLANS.—An award pursuant to subparagraph (A) may not be made unless the application
p.000167: of the political subdivision involved is in co- ordination with, and consistent with, applicable Statewide plans
p.000167: described in subsection (b).
p.000167: (C) RELATIONSHIP TO FORMULA GRANTS.—In the case of a State that will receive an award pursuant to paragraph
p.000167: (3), and in which there is located a political subdivision that will receive an award pursuant to
p.000167: subparagraph (A), the Secretary shall, in determining the amount under paragraph (3)(C) for the
p.000167: State, subtract from the popu-
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p.000175: (1) include input from hospitals and health care facilities (including health care coalitions under
p.000175: section 319C–2), State, local, Tribal, and territorial public health departments, and health care or
p.000175: subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or
p.000175: nu- clear threats, including emerging infectious diseases), as the Assistant Secretary determines
p.000175: appropriate, to meet the goals under section 2802(b)(3);
p.000175: (2) consult and engage with appropriate health care pro- viders and professionals, including physicians,
p.000175: nurses, first re- sponders, health care facilities (including hospitals, primary care clinics, community health
p.000175: centers, mental health facilities, ambulatory care facilities, and dental health facilities), phar- macies,
p.000175: emergency medical providers, trauma care providers, environmental health agencies, public health laboratories,
p.000175: poi- son control centers, blood banks, tissue banks, and other ex- perts that the Assistant Secretary
p.000175: determines appropriate, to meet the goals under section 2802(b)(3);
p.000175: (3) consider feedback related to financial implications for hospitals, health care facilities, public
p.000175: health agencies, labora- tories, blood banks, tissue banks, and other entities engaged in regional preparedness
p.000175: planning to implement and follow such guidelines, as applicable; and
p.000175: (4) consider financial requirements and potential incen- tives for entities to prepare for, and respond
p.000175: to, public health emergencies as part of the regional health care emergency pre- paredness and response system.
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000175: Sec. 319D PUBLIC HEALTH SERVICE ACT 176
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p.000175: (d) TECHNICAL ASSISTANCE.—The Assistant Secretary for Pre- paredness and Response, in consultation with the
p.000175: Director of the Centers for Disease Control and Prevention and the Assistant Sec- retary of Labor for
p.000175: Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guide-
p.000175: lines described in subsection (b).
p.000175: (e) DEMONSTRATION PROJECT FOR REGIONAL HEALTH CARE PREPAREDNESS AND RESPONSE SYSTEMS.—
p.000175: (1) IN GENERAL.—The Assistant Secretary for Prepared- ness and Response may establish a demonstration project
p.000175: pur- suant to the development and implementation of guidelines under subsection (b) to award grants to improve
p.000175: medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve
p.000175: specialty care expertise for all- hazards response, and coordinate medical preparedness and re- sponse across
p.000175: State, local, Tribal, territorial, and regional juris- dictions.
p.000175: (2) SUNSET.—The authority under this subsection shall ex- pire on September 30, 2023.
p.000175: SEC. 319D. ø247d–4¿ FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
p.000175: (a) IN GENERAL.—
p.000175: (1) FINDINGS.—Congress finds that the Centers for Disease Control and Prevention has an essential role in
p.000175: defending against and combatting public health threats domestically and abroad and requires secure and modern
p.000175: facilities, and ex- panded, improved, and appropriately maintained capabilities related to bioterrorism and
p.000175: other public health emergencies, sufficient to enable such Centers to conduct this important mission.
p.000175: (2) FACILITIES.—
p.000175: (A) IN GENERAL.—The Director of the Centers for Dis- ease Control and Prevention may design, construct, and
p.000175: equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings,
p.000175: scientific com- munication facilities, transshipment complexes, secured and isolated parking structures,
p.000175: office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to
p.000175: better conduct the capacities de- scribed in section 319A, and for supporting public health activities.
p.000175: (B) MULTIYEAR CONTRACTING AUTHORITY.—For any project of designing, constructing, equipping, or renovating any
p.000175: facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into
p.000175: a single contract or related contracts that collectively in- clude the full scope of the project, and the
p.000175: solicitation and contract shall contain the clause ‘‘availability of funds’’ found at section 52.232–18 of title
p.000175: 48, Code of Federal Reg- ulations.
p.000175: (3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DIS- EASE CONTROL AND PREVENTION.—The Secretary shall
p.000175: expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control
p.000175: and Prevention relating to
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000177: PUBLIC HEALTH SERVICE ACT
p.000177: Sec. 319D
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p.000177: preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be
p.000177: carried out under the preceding sentence include—
p.000177: (A) expanding or enhancing the training of personnel;
p.000177: (B) improving communications facilities and networks, including delivery of necessary information to rural areas;
p.000177: (C) improving capabilities for public health surveil- lance and reporting activities, taking into account the
p.000177: inte- grated system or systems of public health alert commu- nications and surveillance networks under
p.000177: subsection (b); and
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p.000177: (D) improving laboratory facilities related to bioter- rorism and other public health emergencies,
p.000177: including in- creasing the security of such facilities.
p.000177: (4) STUDY OF RESOURCES FOR FACILITIES AND CAPACITIES.— Not later than June 1, 2022, the Comptroller
p.000177: General of the United States shall conduct a study on Federal spending in fis- cal years 2013 through 2018 for
p.000177: activities authorized under this subsection. Such study shall include a review and assess- ment of
p.000177: obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a
p.000177: specific ac- counting of, and delineation between, obligations and expendi- tures incurred for the construction,
p.000177: renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and
p.000177: the obligations and expenditures incurred to establish and improve the situational awareness and bio-
p.000177: surveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations
p.000177: and expendi- tures.
p.000177: (b) ESTABLISHMENT OF SYSTEMS OF PUBLIC HEALTH COMMU-
p.000177: NICATIONS AND SURVEILLANCE NETWORKS.—
p.000177: (1) IN GENERAL.—The Secretary, directly or through awards of grants, contracts, or cooperative
p.000177: agreements, shall provide for the establishment of an integrated system or sys- tems of public health
p.000177: alert communications and surveillance networks between and among—
p.000177: (A) Federal, State, and local public health officials;
p.000177: (B) public and private health-related laboratories, hos- pitals, poison control centers, immunization information
p.000177: systems, and other health care facilities; and
p.000177: (C) any other entities determined appropriate by the Secretary.
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p.000177: paredness and Advancing Innovation Act of 2019, the Sec- retary, in cooperation with health care providers,
p.000177: State, local, Tribal, and territorial public health officials, and rel- evant Federal agencies (including the
p.000177: Office of the Na- tional Coordinator for Health Information Technology and the National Institute of Standards
p.000177: and Technology), shall, as necessary, adopt technical and reporting standards, in- cluding standards for
p.000177: interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as
p.000177: necessary. Such standards shall be made available on the internet website of the Department of Health and
p.000177: Human Services, in a manner that does not compromise national security.
p.000177: (B) DEFERENCE TO STANDARDS DEVELOPMENT ORGANI- ZATIONS.—In adopting and implementing standards under this
p.000177: subsection and subsection (c), the Secretary shall give deference to standards published by standards develop-
p.000177: ment organizations and voluntary consensus-based stand- ards entities.
p.000177: (c) MODERNIZING PUBLIC HEALTH SITUATIONAL AWARENESS AND BIOSURVEILLANCE.—
p.000177: (1) IN GENERAL.—The Secretary, in collaboration with State, local, and tribal public health
p.000177: officials, shall establish, and improve as applicable and appropriate, a near real-time electronic nationwide
p.000177: public health situational awareness capa- bility through an interoperable network of systems to share data and
p.000177: information to enhance early detection of, rapid re- sponse to, and management of, potentially
p.000177: catastrophic infec- tious disease outbreaks, novel emerging threats, and other public health emergencies
p.000177: that originate domestically or abroad. Such network shall be built on existing State situa- tional
p.000177: awareness systems or enhanced systems that enable such interoperability.
p.000177: (2) COORDINATION AND CONSULTATION.—In establishing
p.000177: and improving the network under paragraph (1), the Secretary shall—
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p.000177: (A) facilitate coordination among agencies within the Department of Health and Human Services that
p.000177: provide, or have the potential to provide, information and data to, and analyses for, the situational
p.000177: awareness and biosurveil- lance network under paragraph (1), including coordination among relevant agencies related
p.000177: to health care services, the facilitation of health information exchange (including the Office of the National
p.000177: Coordinator for Health Informa- tion Technology), and public health emergency prepared- ness and response; and
p.000177: (B) consult with the Secretary of Agriculture, the Sec- retary of Commerce (and the Director of the National
p.000177: In- stitute of Standards and Technology), the Secretary of De- fense, the Secretary of Homeland Security, the
p.000177: Secretary of Veterans Affairs, and the heads of other Federal agen- cies, as the Secretary determines
p.000177: appropriate.
p.000177: (3) ELEMENTS.—
p.000177: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000181: Secretary, and achieve real-time and appropriate data that relate to disease activ- ity, both human and zoonotic;
p.000181: (C) coordinate with applicable existing advisory com- mittees of the Director of the Centers for Disease
p.000181: Control and Prevention, including such advisory committees con- sisting of representatives from State, local, and
p.000181: tribal pub- lic health authorities and appropriate public and private sector health care entities, animal health
p.000181: organizations re- lated to zoonotic disease, and academic institutions, in order to provide guidance on public
p.000181: health surveillance ac- tivities; and
p.000181: (D) provide recommendations to the Secretary on poli- cies and procedures to complete the steps described in this
p.000181: paragraph in a manner that is consistent with section 2802.
p.000181: (8) SITUATIONAL AWARENESS AND BIOSURVEILLANCE AS A NATIONAL SECURITY PRIORITY.—The Secretary, on a
p.000181: periodic basis as applicable and appropriate, shall meet with the Direc- tor of National Intelligence to inform the
p.000181: development and ca- pabilities of the nationwide public health situational awareness and biosurveillance network.
p.000181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000183: PUBLIC HEALTH SERVICE ACT
p.000183: Sec. 319D
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p.000183: (d) STATE AND REGIONAL SYSTEMS TO ENHANCE SITUATIONAL AWARENESS IN PUBLIC HEALTH EMERGENCIES.—
p.000183: (1) IN GENERAL.—To implement the network described in subsection (c), the Secretary may award grants to
p.000183: States or consortia of States to enhance the ability of such States or con- sortia of States to establish or
p.000183: operate a coordinated public health situational awareness system for regional or Statewide early detection
p.000183: of, rapid response to, and management of po- tentially catastrophic infectious disease outbreaks and
p.000183: public health emergencies, in collaboration with appropriate public health agencies, environmental health
p.000183: agencies, sentinel hos- pitals, clinical laboratories, pharmacies, poison control centers, immunization programs,
p.000183: other health care organizations, and animal health organizations within such States.
p.000183: (2) ELIGIBILITY.—To be eligible to receive a grant under paragraph (1), the State or consortium of
p.000183: States shall submit to the Secretary an application at such time, in such manner, and containing such
p.000183: information as the Secretary may require, including an assurance that the State or consortium of States will
p.000183: submit to the Secretary—
p.000183: (A) reports of such data, information, and metrics as the Secretary may require;
p.000183: (B) a report on the effectiveness of the systems funded under the grant;
p.000183: (C) a description of the manner in which grant funds will be used to enhance the timelines and
p.000183: comprehensive- ness of efforts to detect, respond to, and manage poten- tially catastrophic infectious
p.000183: disease outbreaks and public health emergencies; and
p.000183: (D) an implementation plan that may include measur- able steps to achieve the purposes described in paragraph
p.000183: (1).
p.000183: (3) USE OF FUNDS.—A State or consortium of States that receives an award under this subsection—
p.000183: (A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional
p.000183: or Statewide early detection of, rapid response to, and man- agement of potentially catastrophic infectious
p.000183: disease out- breaks and public health emergencies;
p.000183: (B) may award grants or contracts to entities de- scribed in paragraph (1) within or serving such State to as-
p.000183: sist such entities in improving the operation of information technology systems, facilitating the secure
p.000183: exchange of data and information, and training personnel to enhance the operation of the system described in
p.000183: subparagraph (A); and
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p.000183: (C) may conduct a pilot program for the development of multi-State telehealth network test beds that
p.000183: build on, enhance, and securely link existing State and local tele- health programs to prepare for,
p.000183: monitor, respond to, and manage the events of public health emergencies, facilitate coordination and
p.000183: communication among medical, public health, and emergency response agencies, and provide medical
p.000183: services through telehealth initiatives within the
p.000183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000183: States that are involved in such a multi-State telehealth network test bed.
p.000183: (4) LIMITATION.—Information technology systems acquired or implemented using grants awarded under this section must
p.000183: be compliant with—
p.000183: (A) interoperability and other technological standards, as determined by the Secretary; and
p.000183: (B) data collection and reporting requirements for the network described in subsection (c).
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p.000183: subsection regarding interoper- ability and the technical standards set forth by the Secretary.
p.000183: (e) TELEHEALTH ENHANCEMENTS FOR EMERGENCY RESPONSE.—
p.000183: (1) EVALUATION.—The Secretary, in consultation with the Federal Communications Commission and other relevant
p.000183: Fed- eral agencies, shall—
p.000183: (A) conduct an inventory of telehealth initiatives in ex- istence on the date of enactment of the Pandemic and All-
p.000183: Hazards Preparedness Act, including—
p.000183: (i) the specific location of network components;
p.000183: (ii) the medical, technological, and communica- tions capabilities of such components;
p.000183: (iii) the functionality of such components; and
p.000183: (iv) the capacity and ability of such components to handle increased volume during the response to a pub- lic health
p.000183: emergency;
p.000183: (B) identify methods to expand and interconnect the regional health information networks funded by the
p.000183: Sec- retary, the State and regional broadband networks funded through the rural health care support mechanism
p.000183: pilot program funded by the Federal Communications Commis- sion, and other telehealth networks;
p.000183: (C) evaluate ways to prepare for, monitor, respond rapidly to, or manage the events of, a public health emer-
p.000183: gency through the enhanced use of telehealth technologies, including mechanisms for payment or reimbursement for
p.000183: use of such technologies and personnel during public health emergencies;
p.000183: (D) identify methods for reducing legal barriers that deter health care professionals from providing
p.000183: telemedicine services, such as by utilizing State emergency health care professional credentialing
p.000183: verification systems, encour- aging States to establish and implement mechanisms to improve interstate
p.000183: medical licensure cooperation, facili- tating the exchange of information among States regarding investigations and
p.000183: adverse actions, and encouraging States to waive the application of licensing requirements during a public
p.000183: health emergency;
p.000183: (E) evaluate ways to integrate the practice of telemedi- cine within the National Disaster Medical System; and
p.000183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000185: PUBLIC HEALTH SERVICE ACT
p.000185: Sec. 319D
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p.000185: threats to human or animal health, in order to achieve early warn- ing and identification of such health threats,
p.000185: early detection and prompt ongoing tracking of health events, and overall situational awareness of disease
p.000185: activity.
p.000185: SEC. 319D–1. ø247d-4b¿ CHILDREN’S PREPAREDNESS UNIT.
p.000185: (a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.— The Secretary, acting through the Director of the
p.000185: Centers for Dis- ease Control and Prevention (referred to in this subsection as the ‘‘Director’’), shall
p.000185: maintain an internal team of experts, to be known as the Children’s Preparedness Unit (referred to in
p.000185: this sub- section as the ‘‘Unit’’), to work collaboratively to provide guidance on the considerations for, and
p.000185: the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the
p.000185: Director regarding emergency preparedness and response ef- forts pertaining to children at the Centers for
p.000185: Disease Control and Prevention.
p.000185: (b) EXPERTISE.—The team described in subsection (a) shall in- clude one or more pediatricians, which may be a
p.000185: developmental-be- havioral pediatrician, and may also include behavioral scientists, child psychologists,
p.000185: epidemiologists, biostatisticians, health commu- nications staff, and individuals with other areas of expertise, as the
p.000185: Secretary determines appropriate.
p.000185: (c) DUTIES.—The team described in subsection (a) may—
p.000185: (1) assist State, local, Tribal, and territorial emergency planning and response activities related to children,
p.000185: which may include developing, identifying, and sharing best practices;
p.000185: (2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public
p.000185: health of- ficials to improve preparedness and response capabilities with respect to the needs of children,
p.000185: including providing such tech- nical assistance, training, and consultation to eligible entities in order to
p.000185: support the achievement of measurable evidence- based benchmarks and objective standards applicable to sec-
p.000185: tions 319C–1 and 319C–2;
p.000185: (3) improve the utilization of methods to incorporate the needs of children in planning for and
p.000185: responding to a public health emergency, including public awareness of such methods;
p.000185: (4) coordinate with, and improve, public-private partner- ships, such as health care coalitions
p.000185: pursuant to sections 319C–2 and 319C–3, to address gaps and inefficiencies in emergency preparedness and
p.000185: response efforts for children;
p.000185: (5) provide expertise and input during the development of guidance and clinical recommendations to address the
p.000185: needs of children when preparing for, and responding to, public health emergencies, including pursuant to
p.000185: section 319C–3; and
p.000185: (6) carry out other duties related to preparedness and re- sponse activities for children, as the
p.000185: Secretary determines ap- propriate.
p.000185: SEC. 319E. ø247d–5¿ COMBATING ANTIMICROBIAL RESISTANCE.
p.000185: (a) TASK FORCE.—
p.000185: (1) IN GENERAL.—The Secretary shall establish an Anti- microbial Resistance Task Force to provide advice
p.000185: and rec- ommendations to the Secretary and coordinate Federal pro-
p.000185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000187: PUBLIC HEALTH SERVICE ACT
p.000187: Sec. 319E
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p.000187: January 30, 2020
p.000187: grams relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other
...

p.000189: (i) antimicrobial resistance data using a standard- ized approach; and
p.000189: (ii) trends in the utilization of drugs approved under such section 506(h) with respect to patient pop-
p.000189: ulations.
p.000189: (2) USE OF SYSTEMS.—The Secretary shall use available systems, including the National Healthcare Safety Network
p.000189: or other systems identified by the Secretary, to fulfill the require- ments or conduct activities under this section.
p.000189: (k) ANTIMICROBIAL.—For purposes of subsections (f) through (j), the term ‘‘antimicrobial’’ includes any
p.000189: antibacterial or antifungal drugs, and may include drugs that eliminate or inhibit the growth of other
p.000189: microorganisms, as appropriate.
p.000189: (l) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this section shall be used to supplement and not
p.000189: supplant other Federal, State, and local public funds provided for activities under this section.
p.000189: (m) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000189: $40,000,000 for fiscal year 2001, $25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may
p.000189: be necessary for each of the fiscal years 2004 through 2006.
p.000189: SEC. 319F. ø247d–6¿ PUBLIC HEALTH COUNTERMEASURES TO A BIO- TERRORIST ATTACK.
p.000189: (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE CURRICULA AND TRAINING.—
p.000189: (1) IN GENERAL.—The Secretary, in collaboration with the Secretary of Defense, and in consultation with
p.000189: relevant public and private entities, shall develop core health and medical re- sponse curricula and trainings by
p.000189: adapting applicable existing curricula and training programs to improve responses to public health emergencies.
p.000189: (2) CURRICULUM.—The public health and medical response training program may include course work related to—
p.000189: (A) medical management of casualties, taking into ac- count the needs of at-risk individuals;
p.000189: (B) public health aspects of public health emergencies;
p.000189: (C) mental health aspects of public health emer- gencies;
p.000189: (D) national incident management, including coordina- tion among Federal, State, local, tribal, international agen-
p.000189: cies, and other entities; and
p.000189: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000191: PUBLIC HEALTH SERVICE ACT
p.000191: Sec. 319F
p.000191:
p.000191: (E) protecting health care workers and health care first responders from workplace exposures during a public
p.000191: health emergency.
p.000191: (3) PEER REVIEW.—On a periodic basis, products prepared as part of the program shall be rigorously
p.000191: tested and peer-re- viewed by experts in the relevant fields.
p.000191: (4) CREDIT.—The Secretary and the Secretary of Defense shall—
p.000191: (A) take into account continuing professional education requirements of public health and healthcare professions;
p.000191: and
p.000191: (B) cooperate with State, local, and tribal accrediting agencies and with professional associations in
p.000191: arranging for students enrolled in the program to obtain continuing professional education credit for program
p.000191: courses.
p.000191: (5) DISSEMINATION AND TRAINING.—
p.000191: (A) IN GENERAL.—The Secretary may provide for the dissemination and teaching of the materials described
p.000191: in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary.
p.000191: (B) CERTAIN ENTITIES.—The education and training ac- tivities described in subparagraph (A) may be carried out
p.000191: by Federal public health, medical, or dental entities, ap- propriate educational entities, professional
p.000191: organizations and societies, private accrediting organizations, and other nonprofit institutions or entities
p.000191: meeting criteria estab- lished by the Secretary.
p.000191: (C) GRANTS AND CONTRACTS.—In carrying out this sub- section, the Secretary may carry out activities directly or
p.000191: through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
p.000191: (b) ADVICE TO THE FEDERAL GOVERNMENT.—
p.000191: (1) REQUIRED ADVISORY COMMITTEES.—In coordination with the working group under subsection (a), the
p.000191: Secretary shall establish advisory committees in accordance with para- graphs (2) and (3) to provide expert
p.000191: recommendations to assist such working groups in carrying out their respective respon- sibilities under
p.000191: subsections (a) and (b) 19.
p.000191: (2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER- RORISM 20.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the National Advisory Committee on At-Risk In- dividuals and Public Health Emergencies (referred
p.000191: to in this paragraph as the ‘‘Advisory Committee’’).
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p.000191: January 30, 2020
p.000191: 19 Probably should be ‘‘to assist such working group in carrying out its responsibilities under subsection (a)’’.
p.000191: Formerly there were two working groups, one under subsection (a) and one under subsection (b). Now there is
p.000191: only the working group under subsection (a). See the amend- ments made by sections 104(a) and 108 of Public Law 107–188
p.000191: (116 Stat. 605, 609).
p.000191: 20 The heading for subsection (b)(2) probably should read ‘‘NATIONAL ADVISORY COMMITTEE ON AT-RISK INDIVIDUALS AND
p.000191: PUBLIC HEALTH EMERGENCIES’’. The amendment made by section 301(d)(1) of Public Law 109–417 (120 Stat.
p.000191: 2854) to strike ‘‘CHILDREN AND TERRORISM’’ and in- sert ‘‘AT-RISK INDIVIDUALS AND PUBLIC HEALTH
p.000191: EMERGENCIES’’ could not be executed due to incor- rect capitalization of the word ‘‘Children’’ in the matter to be
p.000191: struck. Also the letter ‘‘A’’ in the word ‘‘At-risk’’ in the inserted text probably should be lowercase type.
p.000191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000191: Sec. 319F PUBLIC HEALTH SERVICE ACT 192
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p.000191: January 30, 2020
p.000191:
p.000191: (B) DUTIES.—The Advisory Committee shall provide recommendations regarding—
p.000191: (i) the preparedness of the health care (including mental health care) system to respond to public health
p.000191: emergencies as they relate to at-risk individuals;
p.000191: (ii) needed changes to the health care and emer- gency medical service systems and emergency medical services
p.000191: protocols to meet the special needs of at-risk individuals; and
p.000191: (iii) changes, if necessary, to the national stockpile under section 121 of the Public Health Security and
p.000191: Bioterrorism Preparedness and Response Act of 2002 to meet the emergency health security of at-risk indi-
p.000191: viduals.
p.000191: (C) COMPOSITION.—The Advisory Committee shall be composed of such Federal officials as may be appropriate
p.000191: to address the special needs of the diverse population groups of at-risk populations.
p.000191: (D) TERMINATION.—The Advisory Committee termi- nates six years after the date of the enactment of the Pub- lic
p.000191: Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002.
p.000191: (3) EMERGENCY PUBLIC INFORMATION AND COMMUNICA- TIONS ADVISORY COMMITTEE.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the Emergency Public Information and Commu- nications Advisory Committee (referred to in this
p.000191: para- graph as the ‘‘EPIC Advisory Committee’’).
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p.000195: January 30, 2020
p.000195:
p.000195: (iii) is a product or technology intended to en- hance the use or effect of a drug, biological product, or
p.000195: device described in clause (i) or (ii).
p.000195: (B) INFECTIOUS DISEASE.—The term ‘‘infectious dis- ease’’ means a disease potentially caused by a
p.000195: pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and
p.000195: that reproduces in that person.
p.000195: (3) INTERAGENCY COOPERATION.—
p.000195: (A) IN GENERAL.—In carrying out activities under this section, the Secretary is authorized, subject to subpara-
p.000195: graph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of
p.000195: the United States Government.
p.000195: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000195: the authorities provided by this section.
p.000195: (4) AVAILABILITY OF FACILITIES TO THE SECRETARY.—In any grant, contract, or cooperative agreement entered
p.000195: into under the authority provided in this section with respect to a bio- containment laboratory or other
p.000195: related or ancillary specialized research facility that the Secretary determines necessary for the purpose of
p.000195: performing, administering, or supporting quali- fied countermeasure research and development, the Secretary
p.000195: may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be
p.000195: available as needed to the Secretary to respond to public health emergencies affect- ing national security.
p.000195: (5) TRANSFERS OF QUALIFIED COUNTERMEASURES.—Each agreement for an award of a grant, contract, or
p.000195: cooperative agreement under section 319F(e) for the development of a qualified countermeasure shall provide
p.000195: that the recipient of the award will comply with all applicable export-related controls with respect to such
p.000195: countermeasure.
p.000195: (b) EXPEDITED PROCUREMENT AUTHORITY.—
p.000195: (1) INCREASED SIMPLIFIED ACQUISITION THRESHOLD FOR QUALIFIED COUNTERMEASURE PROCUREMENTS.—
p.000195: (A) IN GENERAL.—For any procurement by the Sec- retary of property or services for use (as determined by the
p.000195: Secretary) in performing, administering, or supporting qualified countermeasure research or development
p.000195: activi- ties under this section that the Secretary determines nec- essary to respond to pressing research
p.000195: and development needs under this section, the amount specified in section 4(11) of the Office of Federal
p.000195: Procurement Policy Act (41
p.000195: U.S.C. 403(11)), as applicable pursuant to section 302A(a) of the Federal Property and Administrative Services
p.000195: Act of 1949 (41 U.S.C. 252a(a)), shall be deemed to be
p.000195: $25,000,000 in the administration, with respect to such procurement, of—
p.000195: (i) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000195: 253(g)(1)(A)) and its implementing regulations; and
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000407: Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption
p.000407: not later than 14 days after the first date
p.000407: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000407: Sec. 351A PUBLIC HEALTH SERVICE ACT 408
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p.000407: on which both of the following conditions have been met by the person requesting the exemption:
p.000407: (I) The person has submitted to the Secretary an application for the exemption meeting the re- quirements
p.000407: established by the Secretary.
p.000407: (II) The person has notified the Secretary that the investigation has been authorized under such an Act.
p.000407: (3) PUBLIC HEALTH EMERGENCIES.—The Secretary may temporarily exempt a person from the applicability
p.000407: of the re- quirements of this section, in whole or in part, if the Secretary determines that such exemption is
p.000407: necessary to provide for the timely participation of the person in a response to a domestic or foreign public
p.000407: health emergency (whether determined under section 319(a) or otherwise) that involves a listed agent or toxin.
p.000407: With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary,
p.000407: after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.
p.000407: (4) AGRICULTURAL EMERGENCIES.—Upon request of the Secretary of Agriculture, after the granting by
p.000407: such Secretary of an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of
p.000407: 2002 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human
p.000407: Services may temporarily exempt a person from the applicability of the requirements of this section, in
p.000407: whole or in part, to provide for the timely participation of the person in a response to the agricultural
p.000407: emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not
p.000407: exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human
p.000407: Services may, after review of whether such exemption remains necessary, provide one extension of an additional
p.000407: 30 days.
p.000407: (h) DISCLOSURE OF INFORMATION.—
p.000407: (1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal agency specified in paragraph (2) shall disclose under
p.000407: section 552 of title 5, United States Code, any of the following:
p.000407: (A) Any registration or transfer documentation sub- mitted under subsections (b) and (c) for the
p.000407: possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that
p.000407: it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses
p.000407: the identity or location of a specific registered person.
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p.000605: the na- tional research institutes;
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p.000607: PUBLIC HEALTH SERVICE ACT
p.000607: Sec. 402
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p.000607: (11)(A) shall oversee research training for all of the na- tional research institutes and National
p.000607: Research Service Awards in accordance with section 487; and
p.000607: (B) may conduct and support research training—
p.000607: (i) for which fellowship support is not provided under section 487; and
p.000607: (ii) that does not consist of residency training of physi- cians or other health professionals;
p.000607: (12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that
p.000607: have not received significant funding relative to other matters, to re- spond to new issues and scientific
p.000607: emergencies, and to act on research opportunities of high priority;
p.000607: (13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray
p.000607: expenses for scientific, educational, and research-related conferences;
p.000607: (14) for the national research institutes and administrative entities within the National Institutes of Health—
p.000607: (A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and
p.000607: entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal
p.000607: property, and
p.000607: (B) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise
p.000607: through the Administrator of General Services, buildings or parts of buildings in the District of Columbia
p.000607: or communities lo- cated adjacent to the District of Columbia for use for a pe- riod not to exceed ten years;
p.000607: (15) may secure resources for research conducted by or through the National Institutes of Health;
p.000607: (16) may, without regard to the provisions of title 5, United States Code, governing appointments in
p.000607: the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such
p.000607: title relating to classifica- tion and General Schedule pay rates, establish such technical and scientific
p.000607: peer review groups and scientific program advi- sory committees as are needed to carry out the
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p.000807: will be protected from bias that may stem from such interests; and
p.000807: (3) an agreement that the entity will comply with regula- tions issued under this section.
p.000807: (d) MONITORING OF PROCESS.—The Secretary shall monitor the establishment and conduct of the administrative
p.000807: process estab- lished by an entity pursuant to subsection (a).
p.000807: (e) RESPONSE.—In any case in which the Secretary determines that an entity has failed to comply with subsection (c)
p.000807: regarding a project of research described in subsection (b), the Secretary—
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000807: Sec. 494 PUBLIC HEALTH SERVICE ACT 808
p.000807:
p.000807: (1) shall require that, as a condition of receiving assist- ance, the entity disclose the existence of a
p.000807: financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and
p.000807: (2) may take such other actions as the Secretary deter- mines to be appropriate.
p.000807: (f) DEFINITIONS.—For purposes of this section:
p.000807: (1) The term ‘‘financial interest’’ includes the receipt of consulting fees or honoraria and the ownership of
p.000807: stock or eq- uity.
p.000807: (2) The term ‘‘assistance’’, with respect to conducting a project of research, means a grant, contract,
p.000807: or cooperative agreement.
p.000807: RESEARCH ON PUBLIC HEALTH EMERGENCIES
p.000807: SEC. 494. ø289c¿ If the Secretary determines, after consulta- tion with the Director of NIH, the
p.000807: Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and
p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
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p.000835: January 30, 2020
p.000835:
p.000835: (1) an application for the award is submitted to the official involved;
p.000835: (2) with respect to carrying out the purpose for which the award is to be provided, the application provides
p.000835: assurances of compliance satisfactory to such official; and
p.000835: (3) the application is otherwise in such form, is made in such manner, and contains such agreements,
p.000835: assurances, and information as the official determines to be necessary to carry out the purpose for which the award is
p.000835: to be provided.
p.000835: (o) EMERGENCY RESPONSE.—
p.000835: (1) IN GENERAL.—Notwithstanding section 504 and except as provided in paragraph (2), the Secretary may use not to
p.000835: ex- ceed 2.5 percent of all amounts appropriated under this title for a fiscal year to make
p.000835: noncompetitive grants, contracts or cooperative agreements to public entities to enable such enti- ties to
p.000835: address emergency substance abuse or mental health needs in local communities.
p.000835: (2) EXCEPTIONS.—Amounts appropriated under part C shall not be subject to paragraph (1).
p.000835: (3) EMERGENCIES.—The Secretary shall establish criteria for determining that a substance abuse or mental health
p.000835: emer- gency exists and publish such criteria in the Federal Register prior to providing funds under this
p.000835: subsection.
p.000835: (4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the
p.000835: end of the fiscal year following the fiscal year for which such amounts are appropriated.
p.000835: (p) LIMITATION ON THE USE OF CERTAIN INFORMATION.—No in- formation, if an establishment or person supplying the
p.000835: information or described in it is identifiable, obtained in the course of activities undertaken or supported under
p.000835: section 505 may be used for any purpose other than the purpose for which it was supplied unless such
p.000835: establishment or person has consented (as determined under regulations of the Secretary) to its use for such
p.000835: other purpose. Such information may not be published or released in other form if the person who supplied
p.000835: the information or who is described in it is identifiable unless such person has consented (as determined under
p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
...

p.000971: (d) The Secretary may, for good cause, waive any right of re- covery which he has against a public agency by
p.000971: reason of the fail- ure of such agency to make payments of principal and interest on a loan made to such
p.000971: agency under this part.
p.000971: (e) After any loan to a public agency under this part has been sold and guaranteed, interest paid on such loan
p.000971: and any interest subsidy paid by the Secretary with respect to such loan which is received by the
p.000971: purchaser thereof (or his successor in interest) shall be included in gross income for the purposes of chapter 1 of the
p.000971: In- ternal Revenue Code of 1954.
p.000971: (f) Amounts received by the Secretary as proceeds from the sale of loans under this section shall be deposited
p.000971: in the loan fund established by section 626, and shall be available to the Secretary for the making of
p.000971: further loans under this part in accordance with the provisions of subsection (a)(2) of such section.
p.000971: (g) There is authorized to be appropriated to the Secretary, for deposit in the loan fund established by section 626,
p.000971: $30,000,000 to provide initial capital for the making of direct loans by the Sec- retary to public
p.000971: agencies for the modernization or construction of facilities referred to in subsection (a)(1).
p.000971: PART C—CONSTRUCTION OR MODERNIZATION OF EMERGENCY ROOMS
p.000971: AUTHORIZATION
p.000971: SEC. 631. ø291j–8¿ In order to assist in the provision of ade- quate emergency room service in various
p.000971: communities of the Na- tion for treatment of accident victims and handling of other med- ical emergencies
p.000971: through special project grants for the construction or modernization of emergency rooms of general hospitals,
p.000971: there are authorized to be appropriated $20,000,000 each for the fiscal year ending June 30, 1971, and the
p.000971: next two fiscal years.
p.000971:
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p.000971:
p.000971: January 30, 2020
p.000971: ELIGIBILITY FOR GRANTS
p.000971: SEC. 632. ø291j–9¿ Funds appropriated pursuant to section 631 shall be available for grants by the Secretary
p.000971: for not to exceed 50 per centum of the cost of construction or modernization of emer- gency rooms of
p.000971: public or nonprofit general hospitals, including pro-
p.000971: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000971:
p.000971:
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p.000971: Sec. 633 PUBLIC HEALTH SERVICE ACT 972
p.000971:
p.000971: vision or replacement of medical transportation facilities. Such grants shall be made by the Secretary only
p.000971: after consultation with the State agency designated in accordance with section 604(a)(1) of the Public Health
p.000971: Service Act. In order to be eligible for a grant under this part, the project, and the applicant therefor,
p.000971: must meet such criteria as may be prescribed by regulations. Such regulations shall be so designed as to provide aid
p.000971: only with respect to projects for which adequate assistance is not readily available from other Federal,
p.000971: State, local, or other sources, and to assist in providing modern, efficient, and effective emergency
p.000971: room service needed to care for victims of highway, industrial, agricultural, or other acci- dents and to
p.000971: handle other medical emergencies, and to assist in providing such service in geographical areas which
p.000971: have special need therefor.
p.000971: PAYMENTS
p.000971: SEC. 633. ø291j–10¿ Grants under this part shall be paid in advance or by way of reimbursement, in such
p.000971: installments and on such conditions, as in the judgment of the Secretary will best carry out the purposes of this part.
p.000971: PART D—GENERAL
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p.000971: January 30, 2020
p.000971:
p.000971: FEDERAL HOSPITAL COUNCIL AND ADVISORY COMMITTEES
p.000971: SEC. 641. ø291k¿ (a) In administering this title, the Surgeon General shall consult with a Federal Hospital
p.000971: Council consisting of the Surgeon General, who shall serve as Chairman ex officio, and twelve members
p.000971: appointed by the Secretary of Health, Education, and Welfare. Six of the twelve appointed members shall be
p.000971: persons who are outstanding in fields pertaining to medical facility and health activities, and three of these
p.000971: six shall be authorities in mat- ters relating to the operation of hospitals or other medical facilities, one of them
p.000971: shall be an authority in matters relating to individuals with intellectual disabilities, and one of them shall be an
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p.001183: PUBLIC HEALTH SERVICE ACT
p.001183: Sec. 1212
p.001183:
p.001183: cant extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.001183: contributions.
p.001183: (f) PRIORITY.—The Secretary shall give priority for the award of the contracts or grants described in
p.001183: subsection (a) to any eligible entity that serves a population in a medically underserved area (as defined in section
p.001183: 330(b)(3)).
p.001183: (g) REPORT.—Not later than 90 days after the completion of a pilot project under subsection (a), the
p.001183: recipient of such contract or grant described in shall submit to the Secretary a report containing the results of
p.001183: an evaluation of the program, including an identifica- tion of—
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p.001183: (1) the impact of the regional, accountable emergency care and trauma system on patient health outcomes for various
p.001183: crit- ical care categories, such as trauma, stroke, cardiac emer- gencies, neurological emergencies, and
p.001183: pediatric emergencies;
p.001183: (2) the system characteristics that contribute to the effec- tiveness and efficiency of the program (or lack
p.001183: thereof);
p.001183: (3) methods of assuring the long-term financial sustain- ability of the emergency care and trauma system;
p.001183: (4) the State and local legislation necessary to implement and to maintain the system;
p.001183: (5) the barriers to developing regionalized, accountable emergency care and trauma systems, as well as
p.001183: the methods to overcome such barriers; and
p.001183: (6) recommendations on the utilization of available funding for future regionalization efforts.
p.001183: (h) DISSEMINATION OF FINDINGS.—The Secretary shall, as ap- propriate, disseminate to the public and to
p.001183: the appropriate Com- mittees of the Congress, the information contained in a report made under subsection
p.001183: (g).
p.001183: PART B—FORMULA GRANTS WITH RESPECT TO MODIFICATIONS OF
p.001183: STATE PLANS
p.001183: SEC. 1211. ø300d–11¿ ESTABLISHMENT OF PROGRAM.
p.001183: (a) REQUIREMENT OF ALLOTMENTS FOR STATES.—The Secretary shall for each fiscal year make an allotment for
p.001183: each State in an amount determined in accordance with section 1218. The Secretary shall make payments, as grants,
p.001183: each fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.001183: year involved an application submitted by the State pursuant to section 1217.
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p.001207: (3) to improve national toxic exposure surveillance by en- hancing cooperative activities between poison
p.001207: control centers in the United States, the Centers for Disease Control and Preven- tion, and other government
p.001207: agencies as determined to be ap- propriate and nonduplicative by the Secretary;
p.001207: (4) to research, improve, and enhance the communications and response capability and capacity of the nation’s network
p.001207: of poison control centers to facilitate increased access to the cen- ters through the integration and
p.001207: modernization of the current poison control centers communications and data system, in- cluding enhancing the
p.001207: network’s telephony, Internet, data and social networking technologies;
p.001207: (5) to develop, support, and enhance technology and capa- bilities of professional organizations in the
p.001207: field of poison con- trol to collect national poisoning, toxic occurrence, and related public health data;
p.001207: (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected
p.001207: by organiza- tions described in paragraph (5);
p.001207: (7) to support and expand the toxicologic expertise within poison control centers; and
p.001207: (8) to improve the capacity of poison control centers to an- swer high volumes of contacts and Internet
p.001207: communications, and to sustain and enhance the poison control center’s network capability to respond during times
p.001207: of national crisis or other public health emergencies.
p.001207: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001207:
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p.001207: Sec. 1273 PUBLIC HEALTH SERVICE ACT 1208
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p.001207: January 30, 2020
p.001207:
p.001207: (c) ACCREDITATION.—Except as provided in subsection (d), the Secretary may award a grant to a poison control
p.001207: center under sub- section (a) only if—
p.001207: (1) the center has been accredited by a professional organi- zation in the field of poison control, and the Secretary
p.001207: has ap- proved the organization as having in effect standards for ac- creditation that reasonably provide
p.001207: for the protection of the public health with respect to poisoning; or
p.001207: (2) the center has been accredited by a State government, and the Secretary has approved the State government as hav-
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p.001211: providers to provide trauma care and related acute care at such trauma centers.
p.001211: (2) LIMITATIONS.—In the case of a grant awarded under paragraph (1) to an eligible trauma center, such grant—
p.001211: (A) shall be for a period of at least 1 year and not more than 3 years (and may be renewed at the end of
p.001211: such period); and
p.001211: (B) shall be in an amount that does not exceed, in a year—
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p.001211: January 30, 2020
p.001211: (i) $100,000 for each military trauma care pro- vider that is a physician at such eligible trauma cen-
p.001211: ter; and
p.001211: (ii) $50,000 for each other military trauma care provider at such eligible trauma center.
p.001211: (c) GRANT REQUIREMENTS.—
p.001211: (1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As a condition of receipt of a grant under this section, a
p.001211: grant re- cipient shall agree to allow military trauma care providers pro- viding care pursuant to such grant to—
p.001211: (A) be deployed by the Secretary of Defense for mili- tary operations, for training, or for response to a mass
p.001211: cas- ualty incident; and
p.001211: (B) be deployed by the Secretary of Defense, in con- sultation with the Secretary of Health and Human
p.001211: Serv- ices, for response to a public health emergency pursuant to section 319.
p.001211: (2) USE OF FUNDS.—Grants awarded under this section to an eligible trauma center may be used to train and
p.001211: incorporate military trauma care providers into such trauma center, in- cluding incorporation into
p.001211: operational exercises and training drills related to public health emergencies, expenditures for malpractice
p.001211: insurance, office space, information technology, specialty education and supervision, trauma
p.001211: programs, re- search, and applicable license fees for such military trauma care providers.
p.001211: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect any other provision of
p.001211: law that preempts State licensing requirements for health care professionals, including with respect to military
p.001211: trauma care providers.
p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
p.001211: and the Secretary of De- fense a report for such year that includes information on—
p.001211: (A) the number and types of trauma cases managed by military trauma teams or military trauma care providers
p.001211: pursuant to such grant during such year;
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p.001213: De- fense, shall submit a report to the congressional committees of jurisdiction that includes information on the
p.001213: effect of placing military trauma care providers in trauma centers awarded grants under this section on—
p.001213: (A) maintaining military trauma care providers’ readi- ness and ability to respond to and treat battlefield injuries;
p.001213: (B) providing health care to civilian trauma patients in urban and rural settings;
p.001213: (C) the capability of trauma centers and military trau- ma care providers to increase medical surge capacity,
p.001213: in- cluding as a result of a large-scale event;
p.001213: (D) the ability of grant recipients to maintain the inte- gration of the military trauma providers or teams of
p.001213: pro- viders as part of the trauma center;
p.001213: (E) efforts to incorporate military trauma care pro- viders into operational exercises and training and drills
p.001213: for public health emergencies; and
p.001213: (F) the capability of military trauma care providers to participate as part of a medical response during or in
p.001213: ad- vance of a public health emergency, as determined by the Secretary, or a mass casualty incident.
p.001213: (f) DEFINITIONS.—For purposes of this part:
p.001213: (1) ELIGIBLE HIGH-ACUITY TRAUMA CENTER.—The term ‘‘eli- gible high-acuity trauma center’’ means a Level I trauma
p.001213: cen- ter that satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams
p.001213: to provide trauma care and related acute care at such trauma center.
p.001213: (B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which
p.001213: data are available are treated for a major trauma at such trauma center.
p.001213: (C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
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p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
p.001337: SEC. 1956. ø300x–66¿ SERVICES FOR INDIVIDUALS WITH CO-OCCUR- RING DISORDERS.
p.001337: States may use funds available for treatment under sections 1911 and 1921 to treat persons with
p.001337: co-occurring substance abuse and mental disorders as long as funds available under such sec- tions are
p.001337: used for the purposes for which they were authorized by law and can be tracked for accounting purposes.
p.001337: SEC. 1957. ø300x-67¿ PUBLIC HEALTH EMERGENCIES.
p.001337: In the case of a public health emergency (as determined under section 319), the Secretary, on a State by State basis,
p.001337: may, as the circumstances of the emergency reasonably require and for the pe-
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001337:
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p.001337: Sec. 1958 PUBLIC HEALTH SERVICE ACT 1338
p.001337:
p.001337: riod of the emergency, grant an extension, or waive application deadlines or compliance with any other
p.001337: requirement, of a grant au- thorized under section 521, 1911, or 1921 or an allotment author- ized under
p.001337: Public Law 99–319 (42 U.S.C. 10801 et seq.).
p.001337: SEC. 1958. ø300x-68¿ JOINT APPLICATIONS.
p.001337: The Secretary, acting through the Assistant Secretary for Men- tal Health and Substance Use, shall permit a
p.001337: joint application to be submitted for grants under subpart I and subpart II upon the request of a
p.001337: State. Such application may be jointly reviewed and approved by the Secretary with respect to such subparts,
p.001337: consistent with the purposes and authorized activities of each such grant pro- gram. A State submitting such a
p.001337: joint application shall otherwise meet the requirements with respect to each such subpart.
p.001337:
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p.001521: under this title for sections 2620 and section 2603(b).
p.001521: (b) EMERGENCY AREA AND EMERGENCY PERIOD.—In this sec- tion:
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001521: January 30, 2020
p.001521:
p.001521: (1) EMERGENCY AREA.—The term ‘‘emergency area’’ means a geographic area in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (2) EMERGENCY PERIOD.—The term ‘‘emergency period’’ means the period in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (c) UNOBLIGATED FUNDS.—If funds under a grant under this section are not expended for an emergency in
p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
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p.001535: The duties established in this part for a medical facility—
p.001535: (1) shall apply only to medical information possessed by the facility during the period in which the
p.001535: facility is treating the victim for conditions arising from the emergency, or during the 60-day period beginning
p.001535: on the date on which the victim is transported by emergency response employees to the facility, whichever period
p.001535: expires first; and
p.001535: (2) shall not apply to any extent after the expiration of the 30-day period beginning on the expiration of the
p.001535: applicable pe- riod referred to in paragraph (1), except that such duties shall apply with respect to any request
p.001535: under section 2695B(c) re- ceived by a medical facility before the expiration of such 30-day period.
p.001535: SEC. 2695G. ø300ff–138¿ MISCELLANEOUS PROVISIONS.
p.001535: (a) LIABILITY OF MEDICAL FACILITIES, DESIGNATED OFFICERS, PUBLIC HEALTH OFFICERS, AND GOVERNING
p.001535: ENTITIES.—This part may not be construed to authorize any cause of action for damages or any civil penalty against any
p.001535: medical facility, any designated of- ficer, any other public health officer, or any governing entity of such
p.001535: facility or officer for failure to comply with the duties estab- lished in this part.
p.001535: (b) TESTING.—This part may not, with respect to victims of emergencies, be construed to authorize or require a
p.001535: medical facility to test any such victim for any infectious disease.
p.001535: (c) CONFIDENTIALITY.—This part may not be construed to au- thorize or require any medical facility, any
p.001535: designated officer of emergency response employees, or any such employee, to disclose identifying information
p.001535: with respect to a victim of an emergency or with respect to an emergency response employee.
p.001535: (d) FAILURE TO PROVIDE EMERGENCY SERVICES.—This part may not be construed to authorize any emergency
p.001535: response em- ployee to fail to respond, or to deny services, to any victim of an emergency.
p.001535: (e) NOTIFICATION AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or
p.001535: partially as a result of a public health emergency that has been determined pursuant to section 319(a),
p.001535: individuals or public or private entities are un- able to comply with the requirements of this part,
p.001535: the Secretary may, notwithstanding any other provision of law, temporarily sus- pend, in whole or in part, the
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p.001619: services based on the center’s analysis of health care costs.
p.001619: (3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to permit a center established
p.001619: under sub- section (c)(1)(C) to compel health insurance issuers to provide data to the center.
p.001619: SEC. 2794. ø300gg–95¿ UNIFORM FRAUD AND ABUSE REFERRAL FOR- MAT. 30
p.001619: The Secretary shall request the National Association of Insur- ance Commissioners to develop a model uniform
p.001619: report form for private health insurance issuer seeking to refer suspected fraud and abuse to State
p.001619: insurance departments or other responsible State agencies for investigation. The Secretary shall request
p.001619: that
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p.001619: January 30, 2020
p.001619: 30 So in law. There are two sections 2794s’. Sections 1003 and 6603 of Public Law 111–148 add new
p.001619: section 2794s’ to the end of part C of title XXVII.
p.001619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001621: PUBLIC HEALTH SERVICE ACT
p.001621: Sec. 2802
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p.001621: the National Association of Insurance Commissioners develop rec- ommendations for uniform reporting
p.001621: standards for such referrals.
p.001621:
p.001621: TITLE XXVIII—NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES
p.001621: Subtitle A—National All-Hazards Pre- paredness and Response Planning, Co- ordinating, and Reporting
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p.001621: January 30, 2020
p.001621: SEC. 2801. ø42 U.S.C. 300hh¿ PUBLIC HEALTH AND MEDICAL PRE- PAREDNESS AND RESPONSE FUNCTIONS.
p.001621: (a) IN GENERAL.—The Secretary of Health and Human Serv- ices shall lead all Federal public health and
p.001621: medical response to public health emergencies and incidents covered by the National Response Plan developed
p.001621: pursuant to section 502(6) of the Home- land Security Act of 2002, or any successor plan.
p.001621: (b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration with the Secretary of Veterans Affairs, the
p.001621: Secretary of Transpor- tation, the Secretary of Defense, the Secretary of Homeland Secu- rity, and the
p.001621: head of any other relevant Federal agency, shall es- tablish an interagency agreement, consistent with the
p.001621: National Re- sponse Plan or any successor plan, under which agreement the Sec- retary of Health and Human Services
p.001621: shall assume operational control of emergency public health and medical response assets, as necessary, in the
p.001621: event of a public health emergency, except that members of the armed forces under the authority of the
p.001621: Secretary of Defense shall remain under the command and control of the Sec- retary of Defense, as shall any associated
p.001621: assets of the Department of Defense.
p.001621: SEC. 2802. ø42 U.S.C. 300hh–1¿ NATIONAL HEALTH SECURITY STRAT- EGY.
p.001621: (a) IN GENERAL.—
p.001621: (1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC HEALTH EMERGENCIES.—Beginning in 2018 and
p.001621: every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a
p.001621: coordinated strategy (to be known as the National Health Security Strategy) and any revi- sions thereof, and an
p.001621: accompanying implementation plan for public health emergency preparedness and response. Such Na- tional Health
p.001621: Security Strategy shall describe potential emer- gency health security threats and identify the
p.001621: process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond
p.001621: to such threats and shall be consistent with the national preparedness goal (as described in section 504(a)(19)
p.001621: of the Homeland Security Act of 2002), the National Incident Management System (as defined in sec- tion
p.001621: 501(7) of such Act), and the National Response Plan devel- oped pursuant to section 504 of such Act, or any
p.001621: successor plan.
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001621: Sec. 2802 PUBLIC HEALTH SERVICE ACT 1622
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p.001621: (2) EVALUATION OF PROGRESS.—The National Health Secu- rity Strategy shall include an evaluation of the progress made
p.001621: by Federal, State, local, and tribal entities, based on the evi- dence-based benchmarks and objective
p.001621: standards that measure levels of preparedness established pursuant to section 319C– 1(g). Such evaluation shall
p.001621: include aggregate and State-specific breakdowns of obligated funding spent by major category (as defined by the
p.001621: Secretary) for activities funded through awards pursuant to sections 319C–1 and 319C–2, and an analysis of any
p.001621: changes to the evidence-based benchmarks and objective standards under sections 319C–1 and 319C–2.
p.001621: (3) PUBLIC HEALTH WORKFORCE.—In 2022, the National Health Security Strategy shall include a national
p.001621: strategy for establishing an effective and prepared public health workforce, including defining the functions,
p.001621: capabilities, and gaps in such workforce (including gaps in the environmental health and ani- mal health workforces,
p.001621: as applicable), describing the status of such workforce, identifying strategies to recruit, retain, and
p.001621: protect such workforce from workplace exposures during public health emergencies, and identifying current
p.001621: capabilities to meet the requirements of section 2803.
p.001621: (b) PREPAREDNESS GOALS.—The National Health Security Strategy shall include provisions in furtherance of the
p.001621: following:
p.001621: (1) INTEGRATION.—Integrating public health and public and private medical capabilities with other first
p.001621: responder sys- tems, including through—
p.001621: (A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities
p.001621: through drills and exercises, including drills and exercises to en- sure medical surge capacity for events
p.001621: without notice; and
p.001621: (B) integrating public and private sector public health and medical donations and volunteers.
p.001621: (2) PUBLIC HEALTH.—Developing and sustaining Federal, State, local, and tribal essential public health security
p.001621: capabili- ties, including the following:
p.001621: (A) Disease situational awareness domestically and abroad, including detection, identification, investigation,
p.001621: and related information technology activities.
p.001621: (B) Disease containment including capabilities for iso- lation, quarantine, social distancing,
p.001621: decontamination, rel- evant health care services and supplies, and transpor- tation and disposal of medical
p.001621: waste.
p.001621: (C) Risk communication and public preparedness.
p.001621: (D) Rapid distribution and administration of medical countermeasures.
p.001621: (E) Response to environmental hazards.
p.001621: (3) MEDICAL.—Increasing the preparedness, response capa- bilities, and surge capacity of hospitals, other health care
p.001621: facili- ties (including pharmacies, mental health facilities, and ambu- latory care facilities and which may
p.001621: include dental health fa- cilities), and trauma care, critical care, and emergency medical service systems, with
p.001621: respect to public health emergencies (in- cluding related availability, accessibility, and coordination),
p.001621: which shall include developing plans for the following:
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001623: Sec. 2802
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p.001623: (A) Strengthening public health emergency medical and trauma management and treatment capabilities.
p.001623: (B) Fatality management.
p.001623: (C) Coordinated medical triage and evacuation to ap- propriate medical institutions based on patient
p.001623: medical need, taking into account regionalized systems of care.
p.001623: (D) Rapid distribution and administration of medical countermeasures.
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p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
p.001623: section 319F–3, and ‘‘security countermeasures’’ under section 319F–2.
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001623: Sec. 2803 PUBLIC HEALTH SERVICE ACT 1624
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p.001623: January 30, 2020
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p.001623: (8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESIL- IENCY.—Strengthening the ability of States, local
p.001623: communities, and tribal communities to prepare for, respond to, and be resil- ient in the event of public health
p.001623: emergencies, whether natu- rally occurring, unintentional, or deliberate by—
p.001623: (A) optimizing alignment and integration of medical and public health preparedness and response planning and
p.001623: capabilities with and into routine daily activities; and
p.001623: (B) promoting familiarity with local medical and public health systems.
p.001623: (9) ZOONOTIC DISEASE, FOOD, AND AGRICULTURE.—Improv- ing coordination among Federal, State, local, Tribal, and
p.001623: terri- torial entities (including through consultation with the Sec- retary of Agriculture) to prevent,
p.001623: detect, and respond to out- breaks of plant or animal disease (including zoonotic disease) that could
p.001623: compromise national security resulting from a delib- erate attack, a naturally occurring threat, the intentional adul-
p.001623: teration of food, or other public health threats, taking into ac- count interactions between animal health, human
p.001623: health, and animals’ and humans’ shared environment as directly related to public health emergency
p.001623: preparedness and response capa- bilities, as applicable.
p.001623: (10) GLOBAL HEALTH SECURITY.—Assessing current or po- tential health security threats from abroad to inform
p.001623: domestic public health preparedness and response capabilities.
p.001623: SEC. 2803. ø42 U.S.C. 300hh–2¿ ENHANCING MEDICAL SURGE CAPACITY.
p.001623: (a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part of the joint review described in section 2812(b), the
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p.001625: 1625
p.001625: PUBLIC HEALTH SERVICE ACT
p.001625: Sec. 2811
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p.001625: (1) ANALYSIS.—The Secretary shall conduct an analysis of whether there are Federal facilities which, in
p.001625: the event of a public health emergency, could practicably be used as facilities in which to provide health care.
p.001625: (2) MEMORANDA OF UNDERSTANDING.—If, based on the analysis conducted under paragraph (1), the
p.001625: Secretary deter- mines that there are Federal facilities which, in the event of a public health emergency,
p.001625: could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility,
p.001625: seek to conclude a memorandum of under- standing with the head of the Department or agency that oper-
p.001625: ates such facility that permits the use of such facility to pro- vide health care in the event of a public
p.001625: health emergency.
p.001625:
p.001625: Subtitle B—All-Hazards Emergency Preparedness and Response
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p.001625: SEC. 2811. ø42 U.S.C. 300hh–10¿ COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS PUBLIC HEALTH
p.001625: EMERGENCIES.
p.001625: (a) IN GENERAL.—There is established within the Department of Health and Human Services the position of
p.001625: the Assistant Sec- retary for Preparedness and Response. The President, with the ad- vice and consent of the Senate,
p.001625: shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Sec-
p.001625: retary.
p.001625: (b) DUTIES.—Subject to the authority of the Secretary, the As- sistant Secretary for Preparedness and Response shall
p.001625: utilize expe- rience related to public health emergency preparedness and re- sponse, biodefense, medical
p.001625: countermeasures, and other relevant topics to carry out the following functions:
p.001625: (1) LEADERSHIP.—Serve as the principal advisor to the Sec- retary on all matters related to Federal public health and
p.001625: med- ical preparedness and response for public health emergencies.
p.001625: (2) PERSONNEL.—Register, credential, organize, train, equip, and have the authority to deploy
p.001625: Federal public health and medical personnel under the authority of the Secretary, in- cluding the National
p.001625: Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emer- gency System
p.001625: for Advance Registration of Volunteer Health Professionals.
p.001625: (3) COUNTERMEASURES.—Oversee advanced research, de- velopment, and procurement of qualified countermeasures
p.001625: (as defined in section 319F–1), security countermeasures (as de- fined in section 319F–2), and qualified
p.001625: pandemic or epidemic products (as defined in section 319F–3).
p.001625: (4) COORDINATION.—
p.001625: (A) FEDERAL INTEGRATION.—Coordinate with relevant Federal officials to ensure integration of Federal prepared- ness
p.001625: and response activities for public health emergencies.
p.001625: (B) STATE, LOCAL, AND TRIBAL INTEGRATION.—Coordi- nate with State, local, and tribal public health officials, the
p.001625: Emergency Management Assistance Compact, health care
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001625: systems, and emergency medical service systems to ensure effective integration of Federal public health and
p.001625: medical assets during a public health emergency.
p.001625: (C) EMERGENCY MEDICAL SERVICES.—Promote im- proved emergency medical services medical direction, sys-
p.001625: tem integration, research, and uniformity of data collec- tion, treatment protocols, and policies with
p.001625: regard to pub- lic health emergencies.
p.001625: (D) POLICY COORDINATION AND STRATEGIC DIREC- TION.—Provide integrated policy coordination and strategic
p.001625: direction, before, during, and following public health emer- gencies, with respect to all matters related to Federal
p.001625: pub- lic health and medical preparedness and execution and de- ployment of the Federal response for public
p.001625: health emer- gencies and incidents covered by the National Response Plan described in section 504(a)(6) of
p.001625: the Homeland Secu- rity Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; and such Federal responses
p.001625: covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the
p.001625: Homeland Security Act of 2002 (6
p.001625: U.S.C. 149(c)), including public health emergencies or inci- dents related to cybersecurity threats that present a
p.001625: threat to national health security.
p.001625: (E) IDENTIFICATION OF INEFFICIENCIES.—Identify and minimize gaps, duplication, and other inefficiencies
p.001625: in medical and public health preparedness and response ac- tivities and the actions necessary to overcome
p.001625: these obsta- cles.
p.001625: (F) COORDINATION OF GRANTS AND AGREEMENTS.— Align and coordinate medical and public health grants and
p.001625: cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the
p.001625: extent possible, including program requirements, timelines, and measurable goals, and in consultation with
p.001625: the Secretary of Homeland Security, to—
p.001625: (i) optimize and streamline medical and public health preparedness and response capabilities and the ability of
p.001625: local communities to respond to public health emergencies; and
p.001625: (ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appro-
p.001625: priate.
p.001625: (G) DRILL AND OPERATIONAL EXERCISES.—Carry out drills and operational exercises, in consultation with
p.001625: the Department of Homeland Security, the Department of De- fense, the Department of Veterans Affairs, and other appli-
p.001625: cable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in
p.001625: and policies related to all-hazards medical and public health preparedness and response, including exercises
p.001625: based on—
p.001625: (i) identified threats for which countermeasures are available and for which no countermeasures are
p.001625: available; and
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001627: 1627
p.001627: PUBLIC HEALTH SERVICE ACT
p.001627: Sec. 2811
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p.001627: (ii) unknown threats for which no counter- measures are available.
p.001627: (H) NATIONAL SECURITY PRIORITY.—On a periodic basis consult with, as applicable and appropriate, the Assistant
p.001627: to the President for National Security Affairs, to provide an update on, and discuss, medical and public health
p.001627: pre- paredness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act,
p.001627: including progress on the development, approval, clearance, and li- censure of medical countermeasures.
p.001627: (I) THREAT AWARENESS.—Coordinate with the Director of the Centers for Disease Control and Prevention, the Di-
p.001627: rector of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Secu-
p.001627: rity Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of
p.001627: Agriculture, to maintain a current assessment of national security threats and inform preparedness and response
p.001627: capabilities based on the range of the threats that have the potential to re- sult in a public health
p.001627: emergency.
p.001627: (5) LOGISTICS.—In coordination with the Secretary of Vet- erans Affairs, the Secretary of Homeland Security, the
p.001627: General Services Administration, and other public and private entities, provide logistical support for medical and
p.001627: public health aspects of Federal responses to public health emergencies. Such logistical support shall
p.001627: include working with other relevant Federal, State, local, Tribal, and territorial public health offi-
p.001627: cials and private sector entities to identify the critical infra- structure assets, systems, and networks
p.001627: needed for the proper functioning of the health care and public health sectors that need to be maintained
p.001627: through any emergency or disaster, in- cluding entities capable of assisting with, responding to, and
p.001627: mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary
p.001627: pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T. Stafford
p.001627: Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods
p.001627: to exchange critical informa- tion and deliver products consumed or used to preserve, pro- tect, or sustain
p.001627: life, health, or safety, and sharing of specialized expertise.
p.001627: (6) LEADERSHIP.—Provide leadership in international pro- grams, initiatives, and policies that deal with public
p.001627: health and medical emergency preparedness and response.
p.001627: (7) COUNTERMEASURES BUDGET PLAN.—Develop, and up- date not later than March 15 of each year, a coordinated
p.001627: 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with
p.001627: respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the
p.001627: Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to
p.001627: develop qualified countermeasures (as defined in sec- tion 319F–1), security countermeasures (as defined in
p.001627: section 319F–2), and qualified pandemic or epidemic products (as de-
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001627: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1628
p.001627: fined in section 319F–3) for each such threat. Each such plan shall—
p.001627:
...

p.001633: an advisory com- mittee to be known as the ‘‘National Advisory Committee on Chil-
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001633: Sec. 2811A PUBLIC HEALTH SERVICE ACT 1634
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p.001633: January 30, 2020
p.001633:
p.001633: dren and Disasters’’ (referred to in this section as the ‘‘Advisory Committee’’).
p.001633: (b) DUTIES.—The Advisory Committee shall—
p.001633: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001633: applicable and appropriate;
p.001633: (2) evaluate and provide input with respect to the medical, mental and behavioral, and public health needs of
p.001633: children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
p.001633: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001633: and children, including related drills and exercises pursuant to the prepared- ness goals under section 2802(b).
p.001633: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001633: respect to chil- dren and the medical and public health grants and cooperative agreements as applicable
p.001633: to preparedness and response activities authorized under this title and title III.
p.001633: (d) MEMBERSHIP.—
p.001633: (1) IN GENERAL.—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint
p.001633: not to exceed 25 members to the Advisory Committee. In appointing such members, the Secretary shall ensure
p.001633: that the total mem- bership of the Advisory Committee is an odd number.
p.001633: (2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as
p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
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p.001635: of Veterans Af-
p.001635: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: Sec. 2811B PUBLIC HEALTH SERVICE ACT 1636
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p.001635: fairs, shall establish an advisory committee to be known as the Na- tional Advisory Committee on Seniors and Disasters
p.001635: (referred to in this section as the ‘‘Advisory Committee’’).
p.001635: (b) DUTIES.—The Advisory Committee shall—
p.001635: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001635: applicable and appropriate;
p.001635: (2) evaluate and provide input with respect to the medical and public health needs of seniors related to
p.001635: preparation for, response to, and recovery from all-hazards emergencies; and
p.001635: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001635: relating to seniors, including related drills and exercises pursuant to the preparedness goals under section
p.001635: 2802(b).
p.001635: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001635: respect to sen- iors and the medical and public health grants and cooperative agreements as applicable to
p.001635: preparedness and response activities under this title and title III.
p.001635: (d) MEMBERSHIP.—
p.001635: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more
p.001635: than 17 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001635: total mem- bership of the Advisory Committee is an odd number.
p.001635: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001635: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Administrator of the Centers for Medicare & Medicaid Services.
p.001635: (G) The Administrator of the Administration for Com- munity Living.
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p.001637: January 30, 2020
p.001637: Homeland Security) as the Secretary determines necessary to fulfill the duties of the Advisory Committee.
p.001637: (e) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) EXTENSION OF COMMITTEE.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommenda- tion on whether the Advisory Committee should be extended.
p.001637: SEC. 2811C. ø42 U.S.C. 300hh-10d¿ NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES AND DISASTERS.
p.001637: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security, shall establish a
p.001637: national advisory committee to be known as the National Advisory Committee on In- dividuals with Disabilities and
p.001637: Disasters (referred to in this section as the ‘‘Advisory Committee’’).
p.001637: (b) DUTIES.—The Advisory Committee shall—
p.001637: (1) provide advice and consultation with respect to activi- ties carried out pursuant to section 2814, as
p.001637: applicable and ap- propriate;
p.001637: (2) evaluate and provide input with respect to the medical, public health, and accessibility needs of individuals
p.001637: with dis- abilities related to preparation for, response to, and recovery from all-hazards emergencies; and
p.001637: (3) provide advice and consultation with respect to State emergency preparedness and response activities,
p.001637: including re- lated drills and exercises pursuant to the preparedness goals under section 2802(b).
p.001637: (c) MEMBERSHIP.—
p.001637: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall
p.001637: appoint not more than 17 members to the Advisory Committee. In appointing such members, the Secretary shall
p.001637: ensure that the total membership of the Advisory Committee is an odd number.
p.001637: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001637: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001637: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001637: (B) The Administrator of the Administration for Com- munity Living.
p.001637: (C) The Director of the Biomedical Advanced Research and Development Authority.
p.001637: (D) The Director of the Centers for Disease Control and Prevention.
p.001637: (E) The Commissioner of Food and Drugs.
p.001637: (F) The Director of the National Institutes of Health.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: ery for individuals with disabilities.
p.001637: (d) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (e) DISABILITY DEFINED.—For purposes of this section, the term ‘‘disability’’ has the meaning given such term in
p.001637: section 3 of the Americans with Disabilities Act of 1990.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) RECOMMENDATION.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommendation on whether the Advisory Committee should be extended.
p.001637: SEC. 2811D. ø42 U.S.C. 300hh-10e¿ ADVISORY COMMITTEE COORDINA- TION.
p.001637: (a) IN GENERAL.—The Secretary shall coordinate duties and ac- tivities authorized under sections 2811A, 2811B,
p.001637: and 2811C, and make efforts to reduce unnecessary or duplicative reporting, or un- necessary duplicative meetings
p.001637: and recommendations under such sections, as practicable. Members of the advisory committees au- thorized
p.001637: under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate,
p.001637: that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and
p.001637: individuals with disabilities dur- ing public health emergencies. If such coordination occurs through an in-person
p.001637: meeting, it shall not be considered the required in- person meetings under any of sections
p.001637: 2811A(e), 2811B(e), or 2811C(d).
p.001637: (b) COORDINATION AND ALIGNMENT.—The Secretary, acting through the employee designated pursuant to
p.001637: section 2814, shall align preparedness and response programs or activities to address similar, dual, or
p.001637: overlapping needs of children, seniors, and individ- uals with disabilities, and any challenges in preparing
p.001637: for and re- sponding to such needs.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001639: (c) NOTIFICATION.—The Secretary shall annually notify the congressional committees of jurisdiction
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p.001639: (b) MODIFICATIONS.—
p.001639: (1) IN GENERAL.—Taking into account the findings from the joint review described under paragraph (2), the
p.001639: Secretary shall modify the policies of the National Disaster Medical Sys- tem as necessary.
p.001639: (2) JOINT REVIEW AND MEDICAL SURGE CAPACITY STRATEGIC PLAN.—
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p.001639: January 30, 2020
p.001639: (A) REVIEW.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.001639: Advancing Innovation Act of 2019, the Secretary, in coordination with the Secretary of Homeland Security, the
p.001639: Secretary of Defense, and the Secretary of Veterans Af- fairs, shall conduct a joint review of the National
p.001639: Disaster Medical System. Such review shall include—
p.001639: (i) an evaluation of medical surge capacity, as de- scribed in section 2803(a);
p.001639: (ii) an assessment of the available workforce of the intermittent disaster response personnel described in
p.001639: subsection (c);
p.001639: (iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to
p.001639: simultaneously respond to multiple public health emergencies and the capacity to respond to a nation- wide
p.001639: public health emergency;
p.001639: (iv) the effectiveness of efforts to recruit, retain, and train such workforce; and
p.001639: (v) gaps that may exist in such workforce and rec- ommendations for addressing such gaps.
p.001639: (B) UPDATES.—As part of the National Health Security Strategy under section 2802, the Secretary shall update the
p.001639: findings from the review under subparagraph (A) and provide recommendations to modify the policies of the Na-
p.001639: tional Disaster Medical System as necessary.
p.001639: (3) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI- TIES.—In carrying out paragraph (1), the Secretary shall
p.001639: estab- lish criteria regarding the participation of States and private entities in the National Disaster
p.001639: Medical System, including cri- teria regarding agreements for such participation. The criteria shall include the
p.001639: following:
p.001639: (A) Provisions relating to the custody and use of Fed- eral personal property by such entities, which
p.001639: may in the
p.001639: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645: (4) provide guidance to and ensure that recipients of State and local public health grants include preparedness
p.001645: and re- sponse strategies and capabilities that take into account the medical and public health needs of
p.001645: at-risk individuals in the event of a public health emergency, as described in section
p.001645: 319C–1(b)(2)(A)(iii);
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001645:
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p.001645: Sec. 2815 PUBLIC HEALTH SERVICE ACT 1646
p.001645:
p.001645: (5) ensure that the contents of the strategic national stock- pile take into account at-risk populations as
p.001645: described in sec- tion 2802(b)(4)(B);
p.001645: (6) oversee curriculum development for the public health and medical response training program on medical
p.001645: manage- ment of casualties, as it concerns at-risk individuals as de- scribed in subparagraphs (A) through (C)
p.001645: of section 319F(a)(2);
p.001645: (7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk
p.001645: individuals before, during, and following public health emergencies in as timely a manner as is practicable,
p.001645: including from the time a public health threat is identified;
p.001645: (8) ensure that public health and medical information dis- tributed by the Department of Health and Human
p.001645: Services during a public health emergency is delivered in a manner that takes into account the range of communication
p.001645: needs of the in- tended recipients, including at-risk individuals; and
p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
p.001645:
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p.001645: January 30, 2020
p.001645: 2 So in law. Probably should read ‘‘the Administrator’’.
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001647: 1647
p.001647: PUBLIC HEALTH SERVICE ACT
p.001647: Sec. 2822
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p.001647: Subtitle C—Strengthening Public Health Surveillance Systems
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p.001655: and incom- plete information;
p.001655: (4) provides appropriate information to help guide medical decisions at the time and place of care;
p.001655: (5) ensures the inclusion of meaningful public input in such development of such infrastructure;
p.001655: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001655: Sec. 3001 PUBLIC HEALTH SERVICE ACT 1656
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p.001655: January 30, 2020
p.001655:
p.001655: (6) improves the coordination of care and information among hospitals, laboratories, physician offices,
p.001655: and other enti- ties through an effective infrastructure for the secure and au- thorized exchange of health
p.001655: care information;
p.001655: (7) improves public health activities and facilitates the early identification and rapid response to public
p.001655: health threats and emergencies, including bioterror events and infectious dis- ease outbreaks;
p.001655: (8) facilitates health and clinical research and health care quality;
p.001655: (9) promotes early detection, prevention, and management of chronic diseases;
p.001655: (10) promotes a more effective marketplace, greater com- petition, greater systems analysis, increased
p.001655: consumer choice, and improved outcomes in health care services; and
p.001655: (11) improves efforts to reduce health disparities.
p.001655: (c) DUTIES OF THE NATIONAL COORDINATOR.—
p.001655: (1) STANDARDS.—The National Coordinator shall—
p.001655: (A) review and determine whether to endorse each standard, implementation specification, and certification
p.001655: criterion for the electronic exchange and use of health in- formation that is recommended by the HIT
p.001655: Standards Committee under section 3002 for purposes of adoption under section 3004;
p.001655: (B) make such determinations under subparagraph (A), and report to the Secretary such determinations, not
p.001655: later than 45 days after the date the recommendation is received by the Coordinator; and
p.001655: (C) review Federal health information technology in- vestments to ensure that Federal health information tech-
p.001655: nology programs are meeting the objectives of the strategic plan published under paragraph (3).
p.001655: (2) HIT POLICY COORDINATION.—
p.001655: (A) IN GENERAL.—The National Coordinator shall co- ordinate health information technology policy and
p.001655: pro- grams of the Department with those of other relevant ex- ecutive branch agencies with a goal of avoiding
p.001655: duplication of efforts and of helping to ensure that each agency under- takes health information technology
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Health / sexually transmitted disases

Searching for indicator sexually transmitted:

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p.000145: submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.000145: Commerce of the House of Representatives, a report on the progress made in ad- dressing vector-borne diseases,
p.000145: including tick-borne diseases, through activities carried out under this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000145: to be appropriated
p.000145: $10,000,000 for each of fiscal years 2021 through 2025.
p.000145: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000145:
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p.000147: 147
p.000147: PUBLIC HEALTH SERVICE ACT
p.000147: Sec. 318
p.000147:
p.000147: PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF SEXUALLY TRANSMITTED DISEASES 16
p.000147: SEC. 318. ø247c¿ (a) The Secretary may provide technical as- sistance to appropriate public and non-profit
p.000147: private entities and to scientific institutions for their research in, and training and public health programs for
p.000147: the prevention and control of sexually trans- mitted diseases.
p.000147: (b) The Secretary may make grants to States, political subdivi- sions of States, and any other public and
p.000147: nonprofit private entity for—
p.000147: (1) research into the prevention and control of sexually transmitted diseases;
p.000147: (2) demonstration projects for the prevention and control of sexually transmitted diseases;
p.000147: (3) public information and education programs for the pre- vention and control of such diseases; and
p.000147: (4) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000147: diseases for health professionals (including allied health personnel).
p.000147: (c) The Secretary is also authorized to make project grants to States and, in consultation with the
p.000147: State health authority, to po- litical subdivisions of States, for—
p.000147: (1) sexually transmitted diseases surveillance activities, in- cluding the reporting, screening, and followup of
p.000147: diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
p.000147: (2) casefinding and case followup activities respecting sex- ually transmitted diseases, including contact tracing
p.000147: of infec- tious cases of sexually transmitted diseases and routine test- ing, including laboratory tests and
p.000147: followup systems;
p.000147: (3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
p.000147: (4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and
p.000147: control strat- egies and activities as may be prescribed by the Secretary.
p.000147: (d) The Secretary may make grants to States and political sub- divisions of States for the development,
p.000147: implementation, and eval- uation of innovative, interdisciplinary approaches to the prevention and control of
p.000147: sexually transmitted diseases.
p.000147: (e)(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be
p.000147: appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal
p.000147: years 1995 through 1998.
p.000147: (2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe
p.000147: including records which fully disclose the amount and disposition by such recipient of the
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p.000147: January 30, 2020
p.000147: 16 Title II of Public Law 103–333, an appropriations Act, provides (under the heading relating to the Centers for
p.000147: Disease Control and Prevention; see 108 Stat. 2550) in part as follows: ‘‘That funds appropriated under this heading
p.000147: for fiscal year 1995 and subsequent fiscal years shall be available for payment of the costs of medical care,
p.000147: related expenses, and burial expenses here- after incurred by or on behalf of any person who had
p.000147: participated in the study of untreated syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts
p.000147: and subject to such terms and conditions as prescribed by the Secretary of Health and Human Services and for
p.000147: payment, in such amounts and subject to such terms and conditions, of such costs and expenses hereafter incurred by or
p.000147: on behalf of such person’s wife or offspring determined by the Secretary to have suffered injury or disease from
p.000147: syphilis contracted from such person’’.
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000147: States to the recipient when the furnishing of such supplies or equipment or the detail of such an
p.000147: officer or employee is for the convenience of and at the request of such recipient and for the pur- pose of
p.000147: carrying out the program with respect to which the grant under this section is made. The amount by
p.000147: which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in
p.000147: furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
p.000147: (5) All information obtained in connection with the examina- tion, care, or treatment of any individual under
p.000147: any program which is being carried out with a grant made under this section shall not, without such individual’s
p.000147: consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a
p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
p.000147: (A) in summary, statistical, or other form; or
p.000147: (B) for clinical or research purposes;
p.000147: but only if the identity of the individuals diagnosed or provided care or treatment under such program is not
p.000147: disclosed.
p.000147: (f) Nothing in this section shall be construed to require any State or any political subdivision of a
p.000147: State to have a sexually transmitted diseases program which would require any person, who objects to any
p.000147: treatment provided under such a program, to be treated under such a program.
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p.000147: January 30, 2020
p.000147: INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
p.000147:
p.000147: SEC. 318A. ø247c–1¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000147: Control and Pre- vention, may make grants to States, political subdivisions of States, and other
p.000147: public or nonprofit private entities for the pur- pose of carrying out the activities described in
p.000147: subsection (c) re- garding any treatable sexually transmitted disease that can cause infertility in women if
p.000147: treatment is not received for the disease.
p.000147: (b) AUTHORITY REGARDING INDIVIDUAL DISEASES.—With re- spect to diseases described in subsection (a), the
p.000147: Secretary shall, in making a grant under such subsection, specify the particular dis- ease or diseases with
p.000147: respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000149: PUBLIC HEALTH SERVICE ACT
p.000149: Sec. 318A
p.000149:
p.000149: agrees to carry out this section only with respect to the disease or diseases so specified.
p.000149: (c) AUTHORIZED ACTIVITIES.—With respect to any sexually transmitted disease described in subsection
p.000149: (a), the activities re- ferred to in such subsection are—
p.000149: (1) screening women for the disease and for secondary con- ditions resulting from the disease, subject to
p.000149: compliance with criteria issued under subsection (f);
p.000149: (2) providing treatment to women for the disease;
p.000149: (3) providing counseling to women on the prevention and control of the disease (including, in the case
p.000149: of a woman with the disease, counseling on the benefits of locating and pro- viding such counseling
p.000149: to any individual from whom the woman may have contracted the disease and any individual whom the
p.000149: woman may have exposed to the disease);
p.000149: (4) providing follow-up services;
p.000149: (5) referrals for necessary medical services for women screened pursuant to paragraph (1), including
p.000149: referrals for evaluation and treatment with respect to acquired immune de- ficiency syndrome and other sexually
p.000149: transmitted diseases;
p.000149: (6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5),
p.000149: providing to the partner of the woman the services described in such paragraphs, as ap- propriate;
p.000149: (7) providing outreach services to inform women of the availability of the services described in paragraphs (1)
p.000149: through (6);
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p.000151: January 30, 2020
p.000151: ceding the fiscal year for which the applicant is applying to receive such a grant.
p.000151: (l) REQUIREMENT OF APPLICATION.—
p.000151: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if an application for the grant is
p.000151: submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such
p.000151: form, is made in such manner, and contains such agreements, assurances, and information as the Secretary
p.000151: determines to be necessary to carry out this section.
p.000151: (2) SUBMISSION OF PLAN FOR PROGRAM OF GRANTEE.—
p.000151: (A) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the applicant involved submits to
p.000151: the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a
p.000151: condition of receiving such a grant, including a specifica- tion of the entities through which activities
p.000151: authorized in subsection (c) will be provided.
p.000151: (B) PARTICIPATION OF CERTAIN ENTITIES.—The Sec- retary may make a grant under subsection (a) only if
p.000151: the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has
p.000151: been prepared in consultation with an appropriate number and variety of—
p.000151: (i) representatives of entities in the geographic area involved that provide services for the prevention
p.000151: and control of sexually transmitted diseases, including programs to provide to the public information and edu- cation
p.000151: regarding such diseases; and
p.000151: (ii) representatives of entities in such area that provide family planning services.
p.000151: (m) DURATION OF GRANT.—The period during which payments are made to an entity from a grant under subsection
p.000151: (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary
p.000151: of the payments and subject to the availability of appropriations for the fiscal year involved to make
p.000151: the payments in such year. The preceding sentence may not be construed to establish a limitation on the number
p.000151: of grants under such subsection that may be made to an entity.
p.000151: (n) TECHNICAL ASSISTANCE, AND SUPPLIES AND SERVICES IN
p.000151: LIEU OF GRANT FUNDS.—
p.000151: (1) TECHNICAL ASSISTANCE.—The Secretary may provide training and technical assistance to grantees under subsection
p.000151: (a) with respect to the planning, development, and operation of any program or service carried out under such
p.000151: subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
p.000151: (2) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The Secretary, at the request of a recipient of a
p.000151: grant under sub- section (a), may reduce the amount of such grant by—
p.000151: (A) the fair market value of any supplies or equipment furnished the grant recipient; and
p.000151: (B) the amount of the pay, allowances, and travel ex- penses of any officer or employee of the Government when
p.000151: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: (d) RULE OF CONSTRUCTION.—This section may not be con- strued as requiring any State to reduce or terminate the
p.000369: supply of vaccines provided by the State to any of the entities described in subsection (a)(2).
p.000369: BREAST AND CERVICAL CANCER INFORMATION
p.000369: SEC. 340D. ø256d¿ (a) IN GENERAL.—As a condition of receiv- ing grants, cooperative agreements, or
p.000369: contracts under this Act, each of the entities specified in subsection (c) shall, to the extent
p.000369: determined to be appropriate by the Secretary, make available in- formation concerning breast and cervical
p.000369: cancer.
p.000369: (b) CERTAIN AUTHORITIES.—In carrying out subsection (a), an entity specified in subsection (c)—
p.000369: (1) may make the information involved available to such individuals as the entity determines appropriate;
p.000369: (2) may, as appropriate, provide information under sub- section (a) on the need for self-examination of the
p.000369: breasts and on the skills for such self-examinations;
p.000369: (3) shall provide information under subsection (a) in the language and cultural context most appropriate to the
p.000369: individ- uals to whom the information is provided; and
p.000369: (4) shall refer such clients as the entities determine appro- priate for breast and cervical cancer screening,
p.000369: treatment, or other appropriate services.
p.000369: (c) RELEVANT ENTITIES.—The entities specified in this sub- section are the following:
p.000369: (1) Entities receiving assistance under section 317F (relat- ing to tuberculosis) 53.
p.000369: (2) Entities receiving assistance under section 318 (relat- ing to sexually transmitted diseases).
p.000369: (3) Migrant health centers receiving assistance under sec- tion 329 54.
p.000369: (4) Community health centers receiving assistance under section 330 54.
p.000369: (5) Entities receiving assistance under section 330(h) (re- lating to homeless individuals).
p.000369: (6) Entities receiving assistance under section 340A 54 (re- lating to health services for residents of public
p.000369: housing).
p.000369: (7) Entities providing services with assistance under title V or title XIX.
p.000369: (8) Entities receiving assistance under section 1001 (relat- ing to family planning).
p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
p.000369:
p.000369:
p.000369:
p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000369:
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.000727: Institute, may make grants to, or enter into contracts with, public or nonprofit private entities for the
p.000727: development and operation of centers to conduct basic and clinical research on chronic fatigue syndrome.
p.000727: (b) Each center assisted under this section shall use the facili- ties of a single institution, or be formed
p.000727: from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000727: Director of the Institute.
p.000727: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000727:
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p.000727:
p.000729: 729
p.000729: PUBLIC HEALTH SERVICE ACT
p.000729: Sec. 448
p.000729:
p.000729: RESEARCH AND RESEARCH TRAINING REGARDING TUBERCULOSIS
p.000729: SEC. 447A. ø285f–2¿ In carrying out section 446, the Director of the Institute shall conduct or support
p.000729: research and research training regarding the cause, diagnosis, early detection, prevention and treatment of
p.000729: tuberculosis.
p.000729: SEC. 447B. ø285f–3¿ SEXUALLY TRANSMITTED DISEASE CLINICAL RE- SEARCH AND TRAINING AWARDS.
p.000729: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
p.000729: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000729: treatment of individuals with sexually transmitted diseases.
p.000729: (b) SUPPORT OF PROMISING CLINICIANS.—In order to foster the application of the most current developments in the
p.000729: etiology, patho- genesis, diagnosis, prevention and treatment of sexually trans- mitted diseases, amounts
p.000729: made available under this section shall be directed to the support of promising clinicians through awards
p.000729: for research, study, and practice at centers of excellence in sexually transmitted disease research and treatment.
p.000729: (c) EXCELLENCE IN CERTAIN FIELDS.—Research shall be carried out under awards made under subsection (b) in
p.000729: environments of demonstrated excellence in the etiology and pathogenesis of sexu- ally transmitted diseases
p.000729: and shall foster innovation and integra- tion of such disciplines or other environments determined
p.000729: suitable by the Director of the Institute.
p.000729: SEC. 447C. ø285f–4¿ MICROBICIDE RESEARCH AND DEVELOPMENT.
p.000729: The Director of the Institute, acting through the head of the Division of AIDS, shall, consistent with
p.000729: the peer-review process of the National Institutes of Health, carry out research on, and devel- opment of, safe and
p.000729: effective methods for use by women to prevent the transmission of the human immunodeficiency virus, which may include
p.000729: microbicides.
p.000729: Subpart 7—Eunice Kennedy Shriver National Institute of Child Health and Human Development 31
p.000729: PURPOSE OF THE INSTITUTE
p.000729: SEC. 448. ø285g¿ The general purpose of the National Institute of Child Health and Human Development 32 (hereafter in
p.000729: this sub- part referred to as the ‘‘Institute’’) is the conduct and support of re- search, training, health
p.000729: information dissemination, and other pro- grams with respect to gynecologic health, maternal health, child
p.000729: health, intellectual disabilities, human growth and development,
p.000729:
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p.001463: January 30, 2020
p.001463:
p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
p.001463: (B) by an entity that provides health services on a pre- paid basis;
p.001463: (7) to the maximum extent practicable, that—
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p.001501: January 30, 2020
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p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
p.001501: (g) DEFINITIONS.—In this section:
p.001501: (1) The term ‘‘voluntary opt-out testing’’ means HIV/AIDS testing—
...

p.001511: other sex- ually transmitted diseases;
p.001511: (5) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001511: liver dis- ease and its impact on HIV/AIDS; and
p.001511: (6) information regarding the availability of hepatitis B vaccine and information about hepatitis treatments.
p.001511: (b) COUNSELING OF INDIVIDUALS WITH POSITIVE TEST RE- SULTS.—The Secretary may not make a
p.001511: grant under this part un- less the applicant for the grant agrees that, if the results of testing for HIV/AIDS
p.001511: indicate that the individual has such condition, the applicant will provide to the individual appropriate
p.001511: counseling re- garding the condition, including—
p.001511: (1) information regarding—
p.001511: (A) measures for prevention of, exposure to, and trans- mission of HIV/AIDS, hepatitis B, and hepatitis C;
p.001511: (B) the accuracy and reliability of results of testing for HIV/AIDS, hepatitis B, and hepatitis C; and
p.001511: (C) the significance of the results of such testing, in- cluding the potential for developing AIDS,
p.001511: hepatitis B, or hepatitis C;
p.001511: (2) reviewing the appropriateness of further counseling, testing, and education of the individual regarding
p.001511: HIV/AIDS and other sexually transmitted diseases; and
p.001511: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001511:
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p.001513: PUBLIC HEALTH SERVICE ACT
p.001513: Sec. 2663
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p.001513: (3) providing counseling—
p.001513: (A) on the availability, through the applicant, of early intervention services;
p.001513: (B) on the availability in the geographic area of appro- priate health care, mental health care, and social and sup-
p.001513: port services, including providing referrals for such serv- ices, as appropriate;
p.001513: (C)(i) that explains the benefits of locating and coun- seling any individual by whom the infected individual
p.001513: may have been exposed to HIV/AIDS, hepatitis B, or hepatitis C and any individual whom the infected
p.001513: individual may have exposed to HIV/AIDS, hepatitis B, or hepatitis C; and
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p.000137: (C) the available scientific evidence on the effective- ness or lack of effectiveness of condoms in
p.000137: preventing in- fection with HPV; and
p.000137: (D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of
p.000137: cer- vical cancer purposes in preventing cervical cancer.
p.000137: (2) MEDICALLY ACCURATE INFORMATION.—Educational ma- terial under paragraph (1), and all other relevant
p.000137: educational and prevention materials prepared and printed from this date forward for the public and health
p.000137: care providers by the Sec- retary (including materials prepared through the Food and Drug Administration,
p.000137: the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or
p.000137: by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV
p.000137: shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in
p.000137: preventing the STD the materials are designed to address. Such requirement only applies to materials mass
p.000137: produced for the public and health care providers, and not to routine communications.
p.000137: (d) JOHANNA’S LAW.—
p.000137: (1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
p.000137: (A) IN GENERAL.—The Secretary shall carry out a na- tional campaign to increase the awareness and knowledge of
p.000137: health care providers and women with respect to gynecologic cancers.
p.000137: (B) WRITTEN MATERIALS.—Activities under the na- tional campaign under subparagraph (A) shall include—
p.000137: (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers;
p.000137: and
p.000137: (ii) distributing the materials to members of the public upon request.
p.000137: (C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities under the national campaign under subparagraph
p.000137: (A) shall, in accordance with applicable law and regulations, include developing and placing, in
p.000137: telecommunications media, public service announcements intended to encour- age women to discuss with their
p.000137: physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in
p.000137: which the written materials re- ferred to in subparagraph (B) can be obtained upon re- quest, and shall
p.000137: call attention to early warning signs and risk factors based on the best available medical informa- tion.
p.000137: (2) REPORT AND STRATEGY.—
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p.000665: (i) use the facilities of a single institution or a con- sortium of cooperating institutions, and meet such
p.000665: qualifications as may be prescribed by the Director of the NIH; and
p.000665: (ii) conduct basic and clinical research.
p.000665: (B) DISCRETIONARY REQUIREMENTS.—With respect to Parkinson’s disease, each center assisted under this sub-
p.000665: section may—
p.000665: (i) conduct training programs for scientists and health professionals;
p.000665: (ii) conduct programs to provide information and continuing education to health professionals;
p.000665: (iii) conduct programs for the dissemination of in- formation to the public;
p.000665: (iv) separately or in collaboration with other cen- ters, establish a nationwide data system derived from
p.000665: patient populations with Parkinson’s disease, and where possible, comparing relevant data involving
p.000665: general populations;
p.000665: (v) separately or in collaboration with other cen- ters, establish a Parkinson’s Disease Information
p.000665: Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson’s disease; and
p.000665: (vi) separately or in collaboration with other cen- ters, establish a national education program that
p.000665: fos- ters a national focus on Parkinson’s disease and the care of those with Parkinson’s disease.
p.000665: (3) STIPENDS REGARDING TRAINING PROGRAMS.—A center may use funds provided under paragraph (1) to
p.000665: provide sti- pends for scientists and health professionals enrolled in train- ing programs under paragraph
p.000665: (2)(B).
p.000665: (4) DURATION OF SUPPORT.—Support of a center under this subsection may be for a period not exceeding five
p.000665: years. Such period may be extended by the Director of NIH for one or more additional periods of not more than five
p.000665: years if the operations of such center have been reviewed by an appropriate technical and scientific peer review
p.000665: group established by the Director
p.000665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000665:
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p.000665: Sec. 409C PUBLIC HEALTH SERVICE ACT 666
p.000665:
p.000665: and if such group has recommended to the Director that such period should be extended.
p.000665: (d) MORRIS K. UDALL AWARDS FOR EXCELLENCE IN PARKIN- SON’S DISEASE RESEARCH.—The Director of NIH is
p.000665: authorized to es- tablish a grant program to support investigators with a proven record of excellence and
p.000665: innovation in Parkinson’s disease research and who demonstrate potential for significant future breakthroughs in the
p.000665: understanding of the pathogensis, diagnosis, and treatment of Parkinson’s disease. Grants under this subsection
p.000665: shall be avail- able for a period of not to exceed 5 years.
p.000665: EXPANSION, INTENSIFICATION, AND COORDINATION OF ACTIVITIES OF NATIONAL INSTITUTES OF HEALTH WITH RESPECT TO
p.000665: RESEARCH ON AUTISM SPECTRUM DISORDER 13
p.000665: SEC. 409C. ø284g¿ (a) IN GENERAL.—
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p.001019: (F) paying such scholarships as the Secretary may de- termine for such individuals for any period of health
p.001019: pro- fessions education at a health professions school;
p.001019: (G) paying such stipends as the Secretary may ap- prove for such individuals for any period of
p.001019: education in
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001019: Sec. 739 PUBLIC HEALTH SERVICE ACT 1020
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p.001019: student-enhancement programs (other than regular courses), except that such a stipend may not be
p.001019: provided to an individual for more than 12 months, and such a sti- pend shall be in an amount determined appropriate by
p.001019: the Secretary (notwithstanding any other provision of law re- garding the amount of stipends);
p.001019: (H) carrying out programs under which such individ- uals gain experience regarding a career in a field
p.001019: of pri- mary health care through working at facilities of public or private nonprofit community-based providers of
p.001019: primary health services; and
p.001019: (I) conducting activities to develop a larger and more competitive applicant pool through partnerships with
p.001019: insti- tutions of higher education, school districts, and other community-based entities.
p.001019: (3) DEFINITION.—In this section, the term ‘‘regular course of education of such a school’’ as used in
p.001019: subparagraph (D) in- cludes a graduate program in behavioral or mental health.
p.001019: (b) REQUIREMENTS FOR AWARDS.—In making awards to eligible entities under subsection (a)(1), the Secretary shall give
p.001019: preference to approved applications for programs that involve a comprehensive approach by several public or
p.001019: nonprofit private health or edu- cational entities to establish, enhance and expand educational pro- grams that
p.001019: will result in the development of a competitive appli- cant pool of individuals from disadvantaged
p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
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p.001045: served or rural communities in order to increase the num- ber of individuals trained;
p.001045: (F) those that develop curriculum that will emphasize knowledge and practice in the areas of prevention and
p.001045: health promotion, geriatrics, long-term care, home health and hospice care, and ethics;
p.001045: (G) those that expand or establish interdisciplinary training programs that promote the effectiveness of
p.001045: allied health practitioners in geriatric assessment and the reha- bilitation of the elderly;
p.001045: (H) those that expand or establish demonstration cen- ters to emphasize innovative models to link allied health
p.001045: clinical practice, education, and research;
p.001045: (I) those that provide financial assistance (in the form of traineeships) to students who are participants in
p.001045: any such program; and
p.001045: (i) who plan to pursue a career in an allied health field that has a demonstrated personnel shortage; and
p.001045: (ii) who agree upon completion of the training pro- gram to practice in a medically underserved commu- nity;
p.001045: that shall be utilized to assist in the payment of all or part of the costs associated with tuition, fees and such
p.001045: other sti- pends as the Secretary may consider necessary; and
p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
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p.001235: January 30, 2020
p.001235: TRAINING AND TECHNICAL ASSISTANCE
p.001235: SEC. 1317. ø300e–16¿ (a)(1) The Secretary shall establish a National Health Maintenance Organization Intern
p.001235: Program (here- inafter in this subsection referred to as the ‘‘Program’’) for the pur- pose of providing training
p.001235: to individuals to become administrators and medical directors of health maintenance organizations or to as- sume
p.001235: other managerial positions with health maintenance organi- zations. Under the Program the Secretary may directly
p.001235: provide in- ternships for such training and may make grants to or enter into contracts with health
p.001235: maintenance organizations and other entities to provide such internships.
p.001235: (2) No internship may be provided by the Secretary and no grant may be made or contract entered into
p.001235: by the Secretary for the provision of internships unless an application therefor has been submitted to and
p.001235: approved by the Secretary. Such an application shall be in such form and contain such information, and
p.001235: be sub- mitted to the Secretary in such manner, as the Secretary shall pre- scribe. Section 1306 does not apply
p.001235: to an application submitted under this section.
p.001235: (3) Internships under the Program shall provide for such sti- pends and allowances (including travel and
p.001235: subsistence expenses and dependency allowances) for the recipients of the internships as the Secretary deems
p.001235: necessary. An internship provided an indi- vidual for training at a health maintenance organization or
p.001235: any other entity shall also provide for payments to be made to the orga- nization or other entity for the cost
p.001235: of support services (including the cost of salaries, supplies, equipment, and related items) pro- vided
p.001235: such individual by such organization or other entity. The amount of any such payments to any
p.001235: organization or other entity shall be determined by the Secretary and shall bear a direct rela- tionship
p.001235: to the reasonable costs of the organization or other entity for establishing and maintaining its training programs.
p.001235: (4) Payments under grants under the Program may be made in advance or by way of reimbursement, and at such
p.001235: intervals and on such conditions, as the Secretary finds necessary.
p.001235: (b) The Secretary shall provide technical assistance (1) to enti- ties intending to become a qualified health
p.001235: maintenance organiza- tion within the meaning of section 1310(d), and (2) to health main-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001235: Sec. 1318 PUBLIC HEALTH SERVICE ACT 1236
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Health / substance use

Searching for indicator substance use:

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p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
p.000127: regardless of the outcome of the pregnancy.
p.000127: (2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian tribes, and tribal organizations that participate in the
p.000127: program described in this subsection shall, through the State maternal mortality review committee, develop a
p.000127: process that—
p.000127: (A) provides for confidential case reporting of preg- nancy-associated and pregnancy-related deaths to the
p.000127: ap- propriate State or tribal health agency, including such re- porting by—
p.000127: (i) health care professionals;
...

p.000257: (1) REQUIRED PRIMARY HEALTH SERVICES.—
p.000257: (A) IN GENERAL.—The term ‘‘required primary health services’’ means—
p.000257: (i) basic health services which, for purposes of this section, shall consist of—
p.000257: (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology
p.000257: that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse
p.000257: midwives;
p.000257: (II) diagnostic laboratory and radiologic serv- ices;
p.000257: (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening;
p.000257: (cc) well-child services;
p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
p.000257: (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol;
p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
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p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
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p.000261: (3) RECOGNITION OF HIGH POVERTY.—
p.000261: (A) IN GENERAL.—In making grants under this sub- section, the Secretary may recognize the unique needs
p.000261: of high poverty areas.
p.000261: (B) HIGH POVERTY AREA DEFINED.—For purposes of subparagraph (A), the term ‘‘high poverty area’’ means
p.000261: a catchment area which is established in a manner that is consistent with the factors in subsection
p.000261: (k)(3)(J), and the poverty rate of which is greater than the national average poverty rate as determined by the
p.000261: Bureau of the Census.
p.000261: (d) IMPROVING QUALITY OF CARE.—
p.000261: (1) SUPPLEMENTAL AWARDS.—The Secretary may award supplemental grant funds to health centers funded under
p.000261: this section to implement evidence-based models for increasing ac- cess to high-quality primary care
p.000261: services, which may include models related to—
p.000261: (A) improving the delivery of care for individuals with multiple chronic conditions;
p.000261: (B) workforce configuration;
p.000261: (C) reducing the cost of care;
p.000261: (D) enhancing care coordination;
p.000261: (E) expanding the use of telehealth and technology-en- abled collaborative learning and capacity building models;
p.000261: (F) care integration, including integration of behav- ioral health, mental health, or substance use disorder
p.000261: serv- ices; and
p.000261: (G) addressing emerging public health or substance use disorder issues to meet the health needs of the
p.000261: popu- lation served by the health center.
p.000261: (2) SUSTAINABILITY.—In making supplemental awards under this subsection, the Secretary may consider whether the
p.000261: health center involved has submitted a plan for continuing the activities funded under this subsection after
p.000261: supplemental funding is expended.
p.000261: (3) SPECIAL CONSIDERATION.—The Secretary may give spe- cial consideration to applications for supplemental
p.000261: funding under this subsection that seek to address significant barriers to access to care in areas with a
p.000261: greater shortage of health care providers and health services relative to the national average.
p.000261: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000261: Sec. 330 PUBLIC HEALTH SERVICE ACT 262
p.000261:
p.000261: (e) OPERATING GRANTS.—
p.000261: (1) AUTHORITY.—
p.000261: (A) IN GENERAL.—The Secretary may make grants for the costs of the operation of public and nonprofit
p.000261: private health centers that provide health services to medically underserved populations.
p.000261: (B) ENTITIES THAT FAIL TO MEET CERTAIN REQUIRE- MENTS.—The Secretary may make grants, for a period
p.000261: of not to exceed 1 year, for the costs of the operation of public and nonprofit private entities which provide
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p.000471: for practitioners to review their prescribing patterns in comparison to such patterns of other
p.000471: practitioners in the specialty; and
p.000471: (xi) meeting the purpose of the program estab- lished under section 399O, as described in section
p.000471: 399O(a).
p.000471: (B) Promoting community or health system interven- tions.
p.000471: (C) Evaluating interventions to prevent controlled sub- stance overdoses.
p.000471: (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging
p.000471: public health crises and opportunities to address such cri- ses, such as enhancing public education and awareness on
p.000471: the risks associated with opioids.
p.000471: (3) ADDITIONAL GRANTS.—The Director may award grants to States, localities, and Indian Tribes—
p.000471: (A) to carry out innovative projects for grantees to rap- idly respond to controlled substance misuse, abuse,
p.000471: and overdoses, including changes in patterns of controlled sub- stance use; and
p.000471: (B) for any other evidence-based activity for pre- venting controlled substance misuse, abuse, and
p.000471: overdoses as the Director determines appropriate.
p.000471: (4) RESEARCH.—The Director, in coordination with the As- sistant Secretary for Mental Health and Substance Use
p.000471: and the National Mental Health and Substance Use Policy Labora- tory established under section 501A, as appropriate and
p.000471: appli- cable, may conduct studies and evaluations to address sub- stance use disorders, including
p.000471: preventing substance use dis-
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: Sec. 392A PUBLIC HEALTH SERVICE ACT 472
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p.000471: orders or other related topics the Director determines appro- priate.
p.000471: (b) ENHANCED CONTROLLED SUBSTANCE OVERDOSE DATA COL-
p.000471: LECTION, ANALYSIS, AND DISSEMINATION GRANTS.—
p.000471: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000471: (A) to the extent practicable, carry out any controlled substance overdose data collection activities
p.000471: described in paragraph (2);
p.000471: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000471: out such activity;
p.000471: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and
p.000471: (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to sec- tion
p.000471: 505(d)(1)(A) (relating to the number of individuals ad- mitted to emergency departments as a result of the abuse of
p.000471: alcohol or other drugs).
p.000471: (2) CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION AND ANALYSIS ACTIVITIES.—A controlled substance
p.000471: overdose data collection, analysis, and dissemination activity described in this paragraph is any of the
p.000471: following activities:
p.000471: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal
p.000471: overdoses of controlled substances.
p.000471: (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on
p.000471: such overdoses from appropriate sources such as toxicology re- ports, autopsy reports, death scene
p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
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p.000571: collaboration with the Administrator of the Health Resources and Services Ad- ministration and the heads
p.000571: of other agencies, and in consultation with appropriate health professional associations, shall develop and carry
p.000571: out a program to educate and train health professionals in effective strategies to—
p.000571: (1) better identify and assess patients with obesity or an eating disorder or patients at-risk of
p.000571: becoming obese or devel- oping an eating disorder;
p.000571: (2) counsel, refer, or treat patients with obesity or an eat- ing disorder; and
p.000571: (3) educate patients and their families about effective strategies to improve dietary habits and
p.000571: establish appropriate levels of physical activity.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
p.000571: (a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
p.000571: (1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘‘comprehensive primary health services’’ means the core
p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
p.000571: (B) MENTAL HEALTH.—Mental health and substance use disorder assessments, crisis intervention, counseling,
p.000571: treatment, and referral to a continuum of services includ- ing emergency psychiatric care, community
p.000571: support pro- grams, inpatient care, and outpatient programs.
p.000571: (2) MEDICALLY UNDERSERVED CHILDREN AND ADOLES- CENTS.—
p.000571: (A) IN GENERAL.—The term ‘‘medically underserved children and adolescents’’ means a population of children
p.000571: and adolescents who are residents of an area designated as a medically underserved area or a health
p.000571: professional shortage area by the Secretary.
p.000571: (B) CRITERIA.—The Secretary shall prescribe criteria for determining the specific shortages of personal
p.000571: health services for medically underserved children and adoles- cents under subparagraph (A) that shall—
p.000571: (i) take into account any comments received by the Secretary from the chief executive officer of a State
p.000571: and local officials in a State; and
p.000571: (ii) include factors indicative of the health status of such children and adolescents of an area, including the
p.000571: ability of the residents of such area to pay for health services, the accessibility of such services,
p.000571: the availability of health professionals to such children
p.000571: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000571:
p.000571:
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
p.000573:
p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
p.000573: (A) Communities that have evidenced barriers to pri- mary health care and mental health and substance
p.000573: use disorder prevention services for children and adolescents.
p.000573: (B) Communities with high per capita numbers of chil- dren and adolescents who are uninsured, underinsured, or enrolled
p.000573: in public health insurance programs.
p.000573: (C) Populations of children and adolescents that have historically demonstrated difficulty in accessing health
p.000573: and mental health and substance use disorder prevention serv- ices.
p.000573: (2) The Secretary may give consideration to whether an applicant has received a grant under subsection
p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
p.000573: (2) upon a showing of good cause, waive the requirement that the SBHC provide all required comprehensive
p.000573: primary health services for a designated period of time to be deter- mined by the Secretary.
p.000573: (f) USE OF FUNDS.—
p.000573: (1) FUNDS.—Funds awarded under a grant under this sec- tion—
p.000573:
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p.000573: (A) may be used for—
p.000573: (i) acquiring and leasing equipment (including the costs of amortizing the principle of, and paying inter- est
p.000573: on, loans for such equipment);
p.000573: (ii) providing training related to the provision of required comprehensive primary health services and
p.000573: additional health services;
p.000573: (iii) the management and operation of health cen- ter programs;
p.000573: (iv) the payment of salaries for physicians, nurses, and other personnel of the SBHC; and
p.000573: (B) may not be used to provide abortions.
p.000573: (2) CONSTRUCTION.—The Secretary may award grants which may be used to pay the costs associated with expanding
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p.000679: (4) MEETINGS.—The Committee shall meet at the call of the chairperson of the Committee or upon the
p.000679: request of the Director of NIH, but in no case less often than once each year.
p.000679: (5) DUTIES.—The Committee shall—
p.000679: (A) develop a summary of advances in pain care re- search supported or conducted by the Federal agencies rel-
p.000679: evant to the diagnosis, prevention, treatment, and man- agement of pain and diseases and disorders
p.000679: associated with pain, including information on best practices for the utilization of non-pharmacologic
p.000679: treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and
p.000679: Drug Administration;
p.000679: (B) identify critical gaps in basic and clinical research on—
p.000679:
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p.000679: (i) the symptoms and causes of pain, including the
p.000679: identification of relevant biomarkers and screening models and the epidemiology of acute and chronic
p.000679: pain;
p.000679: (ii) the diagnosis, prevention, treatment, and man- agement of acute and chronic pain, including with re- spect
p.000679: to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared
p.000679: by the Food and Drug Administration; and
p.000679: (iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and
p.000679: chronic pain; and
p.000679: (C) make recommendations to the Director of NIH—
p.000679: (i) to ensure that the activities of the National In- stitutes of Health and other Federal agencies are free of
p.000679: unnecessary duplication of effort;
p.000679: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000679: Sec. 410 PUBLIC HEALTH SERVICE ACT 680
p.000679:
p.000679: (ii) on how best to disseminate information on pain care and epidemiological data related to acute and
p.000679: chronic pain; and
p.000679: (iii) on how to expand partnerships between public entities and private entities to expand collaborative,
p.000679: cross-cutting research.
p.000679: (6) REPORT.—The Secretary shall ensure that rec- ommendations and actions taken by the Director
p.000679: with respect to the topics discussed at the meetings described in paragraph
p.000679: (4) are included in appropriate reports to Congress.
p.000679: (7) REVIEW.—The Secretary shall review the necessity of the Committee at least once every 2 years.
p.000679: PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000679: Subpart 1—National Cancer Institute
p.000679: PURPOSE OF INSTITUTE
p.000679: SEC. 410. ø285¿ The general purpose of the National Cancer Institute (hereafter in this subpart referred to as
p.000679: the ‘‘Institute’’) is the conduct and support of research, training, health information dissemination, and
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p.000825: January 30, 2020
p.000825: TITLE V—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
p.000825: PART A—ORGANIZATION AND GENERAL AUTHORITIES
p.000825: SEC. 501. ø290aa¿ SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
p.000825: (a) ESTABLISHMENT.—The Substance Abuse and Mental Health Services Administration (hereafter referred to in this
p.000825: title as the ‘‘Administration’’) is an agency of the Service.
p.000825: (b) CENTERS.—The following Centers are agencies of the Ad- ministration:
p.000825: (1) The Center for Substance Abuse Treatment.
p.000825: (2) The Center for Substance Abuse Prevention.
p.000825: (3) The Center for Mental Health Services.
p.000825: (c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SEC-
p.000825: RETARY.—
p.000825: (1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant
p.000825: Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘‘Assistant
p.000825: Secretary’’) who shall be ap- pointed by the President, by and with the advice and consent of the Senate.
p.000825: (2) DEPUTY ASSISTANT SECRETARY.—The Assistant Sec- retary, with the approval of the Secretary, may appoint
p.000825: a Dep- uty Assistant Secretary and may employ and prescribe the functions of such officers and employees,
p.000825: including attorneys, as are necessary to administer the activities to be carried out through the
p.000825: Administration.
p.000825: (d) AUTHORITIES.—The Secretary, acting through the Assistant Secretary, shall—
p.000825: (1) supervise the functions of the Centers of the Adminis- tration in order to assure that the
p.000825: programs carried out through each such Center receive appropriate and equitable support and that there is
p.000825: cooperation among the Centers in the implementation of such programs;
p.000825: (2) establish and implement, through the respective Cen- ters, a comprehensive program to improve the
p.000825: provision of treatment and related services to individuals with respect to substance use disorders and mental
p.000825: illness and to improve pre- vention services, promote mental health and protect the legal rights of individuals
p.000825: with mental illnesses and individuals with substance use disorders;
p.000825: (3) carry out the administrative and financial manage- ment, policy development and planning, evaluation,
p.000825: knowledge dissemination, and public information functions that are re- quired for the implementation of this
p.000825: title;
p.000825: (4) assure that the Administration conduct and coordinate demonstration projects, evaluations, and service system
p.000825: assess- ments and other activities necessary to improve the avail- ability and quality of treatment,
p.000825: prevention and related serv- ices;
p.000825: (5) support activities that will improve the provision of treatment, prevention and related services, including
p.000825: the devel-
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
p.000825: delivery and effectiveness of prevention, treat- ment, and recovery support services and are appropriately
p.000825: in- corporated into programs carried out by the Administration;
p.000825: (10) encourage public and private entities that provide health insurance to provide benefits for substance use
p.000825: disorder and mental health services;
p.000825: (11) work with relevant agencies of the Department of Health and Human Services on integrating mental health
p.000825: pro- motion and substance use disorder prevention with general health promotion and disease prevention and
p.000825: integrating men- tal and substance use disorders treatment services with phys- ical health treatment services;
p.000825: (12) monitor compliance by hospitals and other facilities with the requirements of sections 542 and 543;
p.000825: (13) with respect to grant programs authorized under this title or part B of title XIX, or grant programs otherwise
p.000825: funded by the Administration—
p.000825: (A) require that all grants that are awarded for the provision of services are subject to performance
p.000825: and out- come evaluations;
p.000825: (B) ensure that the director of each Center of the Ad- ministration consistently documents the application of cri-
p.000825: teria when awarding grants and the ongoing oversight of grantees after such grants are awarded;
p.000825: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: PUBLIC HEALTH SERVICE ACT
p.000827: Sec. 501
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p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
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p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
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p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: (B) assist the Assistant Secretary in the evaluation, organization, integration, and coordination of programs
p.000831: op- erated by the Administration;
p.000831: (C) promote evidence-based and promising best prac- tices, including culturally and linguistically
p.000831: appropriate practices, as appropriate, for the prevention and treatment of, and recovery from, mental and substance use
p.000831: disorders, including serious mental illness and serious emotional dis- turbances;
p.000831: (D) participate in regular strategic planning with the Administration;
p.000831: (E) coordinate with the Assistant Secretary for Plan- ning and Evaluation to assess the use of
p.000831: performance metrics to evaluate activities within the Administration re- lated to mental and substance use disorders;
p.000831: and
p.000831: (F) coordinate with the Assistant Secretary to ensure mental and substance use disorders grant programs within
p.000831: the Administration consistently utilize appropriate per- formance metrics and evaluation designs.
p.000831: (h) SERVICES OF EXPERTS.—
p.000831: (1) IN GENERAL.—The Assistant Secretary may obtain (in accordance with section 3109 of title 5, United States
p.000831: Code, but without regard to the limitation in such section on the number of days or the period of service) the
p.000831: services of not more than 20 experts or consultants who have professional qualifications. Such experts and
p.000831: consultants shall be obtained for the Admin- istration and for each of its agencies.
p.000831: (2) COMPENSATION AND EXPENSES.—
p.000831: (A) Experts and consultants whose services are ob- tained under paragraph (1) shall be paid or reimbursed for
p.000831: their expenses associated with traveling to and from their assignment location in accordance with sections
p.000831: 5724, 5724a(a), 5724a(c), and 5726(c) of title 5, United States Code.
p.000831: (B) Expenses specified in subparagraph (A) may not be allowed in connection with the assignment of an expert or
p.000831: consultant whose services are obtained under paragraph (1), unless and until the expert or consultant
p.000831: agrees in writing to complete the entire period of assignment or one year, whichever is shorter, unless separated or
p.000831: reassigned for reasons beyond the control of the expert or consultant that are acceptable to the
p.000831: Secretary. If the expert or con- sultant violates the agreement, the money spent by the United States
p.000831: for the expenses specified in subparagraph
p.000831: (A) is recoverable from the expert or consultant as a debt of the United States. The Secretary may waive in
p.000831: whole or in part a right of recovery under this subparagraph.
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p.000833: (2) COORDINATION.—In developing and carrying out the strategic plan under this subsection, the Assistant
p.000833: Secretary shall take into consideration the findings and recommenda- tions of the Assistant Secretary for
p.000833: Planning and Evaluation under section 6021(d) of the Helping Families in Mental Health Crisis
p.000833: Reform Act of 2016 and the report of the Inter- departmental Serious Mental Illness Coordinating
p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: priate, for individuals with a mental or substance use dis- order;
p.000833: (D) identify opportunities to collaborate with the Health Resources and Services Administration to
p.000833: develop or improve—
p.000833: (i) initiatives to encourage individuals to pursue careers (especially in rural and underserved areas and with
p.000833: rural and underserved populations) as psychia- trists, including child and adolescent psychiatrists,
p.000833: psychologists, psychiatric nurse practitioners, physi- cian assistants, clinical social workers, certified
p.000833: peer support specialists, licensed professional counselors, or other licensed or certified mental health or
p.000833: substance use disorder professionals, including such profes- sionals specializing in the diagnosis,
p.000833: evaluation, or treatment of adults with a serious mental illness or children with a serious emotional
p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
p.000833: adults with a se- rious mental illness and children with a serious emotional disturbance, and for individuals with
p.000833: a substance use dis- order.
p.000833: (m) BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.—Not later than September 30, 2020,
p.000833: and every 2 years thereafter, the Assistant Secretary shall prepare and submit to the Committee on Energy and Commerce
p.000833: and the Committee on Appro- priations of the House of Representatives and the Committee on Health, Education,
p.000833: Labor, and Pensions and the Committee on Ap- propriations of the Senate, and post on the Internet website of the
p.000833: Administration, a report containing at a minimum—
p.000833: (1) a review of activities conducted or supported by the Ad- ministration, including progress toward strategic
p.000833: priorities, goals, and objectives identified in the strategic plan developed under subsection (l);
p.000833: (2) an assessment of programs and activities carried out by the Assistant Secretary, including the extent to
p.000833: which pro- grams and activities under this title and part B of title XIX meet identified goals and
p.000833: performance measures developed for the respective programs and activities;
p.000833: (3) a description of the progress made in addressing gaps in mental and substance use disorders
p.000833: prevention, treatment, and recovery services and improving outcomes by the Adminis-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000833:
p.000833:
p.000833:
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p.000833:
p.000833:
p.000835: 835
p.000835: PUBLIC HEALTH SERVICE ACT
p.000835: Sec. 501
p.000835:
p.000835: tration, including with respect to serious mental illnesses, seri- ous emotional disturbances, and co-occurring
p.000835: disorders;
p.000835: (4) a description of the manner in which the Administra- tion coordinates and partners with other Federal
p.000835: agencies and departments related to mental and substance use disorders, in- cluding activities related to—
p.000835: (A) the implementation and dissemination of research findings into improved programs, including with respect to
p.000835: how advances in serious mental illness and serious emo- tional disturbance research have been incorporated
p.000835: into programs;
p.000835: (B) the recruitment, training, and retention of a men- tal and substance use disorders workforce;
p.000835: (C) the integration of mental disorder services, sub- stance use disorder services, and physical health
p.000835: services;
p.000835: (D) homelessness; and
p.000835: (E) veterans;
p.000835: (5) a description of the manner in which the Administra- tion promotes coordination by grantees under
p.000835: this title, and part B of title XIX, with State or local agencies; and
p.000835: (6) a description of the activities carried out under section 501A(e), with respect to mental and substance use
p.000835: disorders, including—
p.000835: (A) the number and a description of grants awarded;
p.000835: (B) the total amount of funding for grants awarded;
p.000835: (C) a description of the activities supported through such grants, including outcomes of programs
p.000835: supported; and
p.000835:
p.000835:
p.000835:
p.000835:
p.000835:
p.000835:
p.000835:
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p.000835:
p.000835:
p.000835:
p.000835:
p.000835: January 30, 2020
p.000835: (D) information on how the National Mental Health and Substance Use Policy Laboratory is consulting with
p.000835: the Assistant Secretary for Planning and Evaluation and collaborating with the Center for Substance Abuse
p.000835: Treat- ment, the Center for Substance Abuse Prevention, the Center for Behavioral Health Statistics and
...

p.000835: emer- gency exists and publish such criteria in the Federal Register prior to providing funds under this
p.000835: subsection.
p.000835: (4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the
p.000835: end of the fiscal year following the fiscal year for which such amounts are appropriated.
p.000835: (p) LIMITATION ON THE USE OF CERTAIN INFORMATION.—No in- formation, if an establishment or person supplying the
p.000835: information or described in it is identifiable, obtained in the course of activities undertaken or supported under
p.000835: section 505 may be used for any purpose other than the purpose for which it was supplied unless such
p.000835: establishment or person has consented (as determined under regulations of the Secretary) to its use for such
p.000835: other purpose. Such information may not be published or released in other form if the person who supplied
p.000835: the information or who is described in it is identifiable unless such person has consented (as determined under
p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
p.000835: SEC. 501A. ø290aa–0¿ NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
p.000835: (a) IN GENERAL.—There shall be established within the Admin- istration a National Mental Health and Substance Use
p.000835: Policy Lab- oratory (referred to in this section as the ‘‘Laboratory’’).
p.000835: (b) RESPONSIBILITIES.—The Laboratory shall—
p.000835: (1) continue to carry out the authorities and activities that were in effect for the Office of Policy, Planning, and
p.000835: Innovation as such Office existed prior to the date of enactment of the Helping Families in Mental Health
p.000835: Crisis Reform Act of 2016;
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000835:
p.000835:
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p.000835:
p.000837: 837
p.000837: PUBLIC HEALTH SERVICE ACT
p.000837: Sec. 501A
p.000837:
p.000837: (2) identify, coordinate, and facilitate the implementation of policy changes likely to have a significant
p.000837: effect on mental health, mental illness, recovery supports, and the prevention and treatment of substance use
p.000837: disorder services;
p.000837: (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information
p.000837: from grant- ees under programs operated by the Administration in order to evaluate and disseminate information on
p.000837: evidence-based prac- tices, including culturally and linguistically appropriate serv- ices, as appropriate, and
p.000837: service delivery models;
p.000837: (4) provide leadership in identifying and coordinating poli- cies and programs, including evidence-based programs,
p.000837: related to mental and substance use disorders;
p.000837: (5) periodically review programs and activities operated by the Administration relating to the diagnosis or
p.000837: prevention of, treatment for, and recovery from, mental and substance use disorders to—
p.000837: (A) identify any such programs or activities that are duplicative;
p.000837: (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
p.000837: (C) formulate recommendations for coordinating, elimi- nating, or improving programs or activities
p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
p.000837:
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p.000837:
p.000837: January 30, 2020
p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
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p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
p.000837:
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p.000837: January 30, 2020
p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
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p.000839: 839
p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
p.000839: (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.
...

p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
p.000845: (b) PREFERENCES.—In awarding grants, contracts, and coopera- tive agreements under subsection (a), the Secretary
p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
p.000845: homeless in- dividuals;
p.000845: (2) entities that demonstrate effectiveness in serving run- away, homeless, and street youth;
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 4 The heading for paragraph (2) is the result of the amendment made by section 6004(6)(C) of Public Law
p.000845: 114–255. Such amendment probably should not have been made to strike ‘‘AN- NUAL SURVEYS’’ (initial cap and
p.000845: small caps) and instead should have been ‘‘Annual Surveys’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000845:
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p.000845: Sec. 506A PUBLIC HEALTH SERVICE ACT 846
p.000845:
p.000845: (3) entities that have experience in providing substance use disorder and mental health services to
p.000845: homeless individ- uals;
p.000845: (4) entities that demonstrate experience in providing hous- ing for individuals in treatment for or in recovery from
p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
...

p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
p.000847: private entities;
p.000847: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000847: of grantees after such grants are awarded;
p.000847: (14) work with States, providers, and individuals in recov- ery, and their families, to promote the expansion
p.000847: of recovery support services and systems of care oriented toward recovery;
p.000847: (15) in cooperation with the Secretary, implement and dis- seminate, as appropriate, the recommendations in the
p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000847:
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
...

p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
p.000849: consultation with the women, prepare an individualized plan for the provi- sion of services for the woman and
p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
p.000849: (A) individual, group, and family counseling, as appro- priate, regarding substance use disorders; and
p.000849: (B) follow-up services to assist the woman in pre- venting a relapse into such a disorder.
p.000849: (d) REQUIRED SUPPLEMENTAL SERVICES.—In the case of an eli- gible woman, the services referred to in subsection (a)(3)
p.000849: are as fol- lows:
p.000849:
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p.000849: January 30, 2020
p.000849: (1) Prenatal and postpartum health care.
p.000849: (2) Referrals for necessary hospital services.
p.000849: (3) For the infants and children of the woman—
p.000849: (A) pediatric health care, including treatment for any perinatal effects of a maternal substance use disorder
p.000849: and including screenings regarding the physical and mental de- velopment of the infants and children;
p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000849:
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849: (5) Training in parenting.
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p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
p.000849: (A) the applicant has the capacity to carry out a pro- gram described in subsection (a);
p.000849: (B) the plans of the applicant for such a program are consistent with the policies of such agency
p.000849: regarding the treatment of substance use disorders; and
p.000849: (C) the applicant, or any entity through which the ap- plicant will provide authorized services, meets all applica- ble
p.000849: State licensure or certification requirements regarding the provision of the services involved.
p.000849: (2) STATUS AS MEDICAID PROVIDER.—
p.000849: (A) IN GENERAL.—Subject to subparagraphs (B) and (C), the Director may make an award under subsection (a) only
p.000849: if, in the case of any authorized service that is avail- able pursuant to the State plan approved under title
p.000849: XIX of the Social Security Act for the State involved—
p.000849: (i) the applicant for the award will provide the service directly, and the applicant has entered into a
p.000849: participation agreement under the State plan and is qualified to receive payments under such plan; or
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000849:
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p.000851: 851
p.000851: PUBLIC HEALTH SERVICE ACT
p.000851: Sec. 508
p.000851:
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p.000851: in kind, fairly evaluated, including plant, equipment, or serv- ices. Amounts provided by the Federal
p.000851: Government, or services assisted or subsidized to any significant extent by the Federal
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000851: Sec. 508 PUBLIC HEALTH SERVICE ACT 852
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p.000851: Government, may not be included in determining the amount of such non-Federal contributions.
p.000851: (g) OUTREACH.—A funding agreement for an award under sub- section (a) for an applicant is that the applicant
p.000851: will provide out- reach services in the community involved to identify women who have a substance use
p.000851: disorder and to encourage the women to un- dergo treatment for such disorder.
p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
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p.000855: ex- tended.
p.000855: (6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For pur- poses of this subsection, the term ‘‘State substance abuse
p.000855: agen- cy’’ means, with respect to a State, the agency in such State that manages the Substance Abuse
p.000855: Prevention and Treatment Block Grant under part B of title XIX.
p.000855: (s) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000855: to be appropriated
p.000855: $29,931,000 for each of fiscal years 2019 through 2023. Of the amounts made available for a year
p.000855: pursuant to theprevious sen- tence to carry out this section, not more than25 percent of such amounts
p.000855: shall be made available for suchyear to carry out sub- section (r), other than paragraph (5) ofsuch
p.000855: subsection. Notwith- standing the preceding sentence, nofunds shall be made available to carry out subsection
p.000855: (r) fora fiscal year unless the amount made available to carry outthis section for such fiscal year is more
p.000855: than the amount madeavailable to carry out this section for fiscal year 2016.
p.000855: SEC. 509. ø290bb–2¿ PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF REGIONAL AND NATIONAL SIGNIFICANCE.
p.000855: (a) PROJECTS.—The Secretary shall address priority substance use disorder treatment needs of regional and
p.000855: national significance (as determined under subsection (b)) through the provision of or through assistance
p.000855: for—
p.000855: (1) knowledge development and application projects for treatment and rehabilitation and the conduct or
p.000855: support of evaluations of such projects;
p.000855: (2) training and technical assistance; and
p.000855: (3) targeted capacity response programs that permit States, local governments, communities, and Indian
p.000855: tribes and tribal organizations (as the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in
p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000857: (c) RESERVATION OF SPACE.—Prior to notifying States of the availability of space at military facilities
p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
p.000861: under the Drug Free Schools and Communities Act of 1986;
p.000861: (9) support the development of model, innovative, commu- nity-based programs that reduce the risk of
p.000861: alcohol and drug abuse among young people and promote resiliency;
p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: Sec. 516 PUBLIC HEALTH SERVICE ACT 862
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p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
p.000861: (B) promoting the integration of substance use dis- order prevention information and activities into
p.000861: primary health care systems; and
p.000861: (C) substance use disorder prevention among high-risk groups.
p.000861: (c) REQUIREMENTS.—
p.000861: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000861: infor- mation and application requirements determined appropriate by the Secretary.
p.000861: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000861: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000861: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000861: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
p.000861: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000861: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
p.000861: matching funds may be provided directly or through donations from public or private entities and may be in
p.000861: cash or in kind, fairly evaluated, including plant, equipment, or services.
p.000861: (4) MAINTENANCE OF EFFORT.—With respect to activities for which a grant, contract, or cooperative agreement
p.000861: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000861: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.000861: less than the level of such expenditures main- tained by the entity for the fiscal year preceding the fiscal year
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000877: which the entity receives such a grant, contract, or coopera- tive agreement.
p.000877: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000877: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000877: (e) INFORMATION AND EDUCATION.—
p.000877: (1) IN GENERAL.—The Secretary shall establish information and education programs to disseminate and apply the findings
p.000877: of the knowledge development and application, training, and technical assistance programs, and targeted
p.000877: capacity response programs, under this section to the general public, to health care professionals, and to
p.000877: interested groups. The Secretary shall make every effort to provide linkages between the find- ings of
p.000877: supported projects and State agencies responsible for carrying out mental health services.
p.000877: (2) RURAL AND UNDERSERVED AREAS.—In disseminating in- formation on evidence-based practices in the provision of
p.000877: chil- dren’s mental health services under this subsection, the Sec- retary shall ensure that such
p.000877: information is distributed to rural and medically underserved areas.
p.000877: (3) GERIATRIC MENTAL DISORDERS.—The Secretary shall, as appropriate, provide technical assistance to grantees regarding
p.000877: evidence-based practices for the prevention and treatment of geriatric mental disorders and co-occurring
p.000877: mental health and substance use disorders among geriatric populations, as well as disseminate information about such
p.000877: evidence-based practices to States and nongrantees throughout the United States.
p.000877: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000877: $394,550,000 for each of fiscal years 2018 through 2022.
p.000877: øSection 520B was repealed by section 9017 of Public Law 114–255.¿
p.000877:
p.000877: January 30, 2020 As Amended Through P.L. 116-94,
p.000877: Enacted December 20, 2019
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p.000877: Sec. 520C PUBLIC HEALTH SERVICE ACT 878
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p.000877: SEC. 520C. ø290bb–34¿ SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.
p.000877: (a) PROGRAM AUTHORIZED.—The Secretary, acting through the Assistant Secretary, shall establish a research,
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p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
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p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000885:
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p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
p.000885: with the Secretary of Education, may award grants on a competitive basis to institutions of higher education
p.000885: to enhance services for students with mental health or substance use disorders that can lead to school
p.000885: failure, such as depression, substance use disorders, and sui- cide attempts, prevent mental and substance use
p.000885: disorders, reduce stigma, and improve the identification and treatment for students at risk, so that students
p.000885: will successfully complete their studies.
p.000885: (b) USE OF FUNDS.—The Secretary may not make a grant to an institution of higher education under this section
p.000885: unless the in- stitution agrees to use the grant only for one or more of the fol- lowing:
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p.000885: January 30, 2020
p.000885: (1) Educating students, families, faculty, and staff to in- crease awareness of mental and substance use
p.000885: disorders.
p.000885: (2) The operation of hotlines.
p.000885: (3) Preparing informational material.
p.000885: (4) Providing outreach services to notify students about available mental and substance use disorder services.
p.000885: (5) Administering voluntary mental and substance use dis- order screenings and assessments.
p.000885: (6) Supporting the training of students, faculty, and staff to respond effectively to students with
p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: 887
p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
p.000887: (1) A description of the population to be targeted by the program carried out under the grant, including
p.000887: veterans when- ever possible and appropriate, and of identified mental and substance use disorder needs of
p.000887: students at the institution of higher education.
p.000887: (2) A description of Federal, State, local, private, and insti- tutional resources currently available to address the
p.000887: needs de- scribed in paragraph (1) at the institution of higher education, which may include, as appropriate and in
p.000887: accordance with sub- section (b)(7), a plan to seek input from relevant stakeholders in the community,
p.000887: including appropriate public and private en- tities, in order to carry out the program under the grant.
p.000887: (3) A description of the outreach strategies of the institu- tion of higher education for promoting
p.000887: access to services, in- cluding a proposed plan for reaching those students most in need of mental health
p.000887: services.
p.000887: (4) A plan to evaluate program outcomes, including a de- scription of the proposed use of funds, the
...

p.000887: (1) IN GENERAL.—The Secretary may make a grant under this section to an institution of higher education only if
p.000887: the in- stitution agrees to make available (directly or through dona- tions from public or private entities)
p.000887: non-Federal contributions
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000887:
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p.000887: Sec. 520E–3 PUBLIC HEALTH SERVICE ACT 888
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p.000887: January 30, 2020
p.000887:
p.000887: in an amount that is not less than $1 for each $1 of Federal funds provided in the grant, toward the costs
p.000887: of activities car- ried out with the grant (as described in subsection (b)) and other activities by the
p.000887: institution to reduce student mental health and substance use disorders.
p.000887: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required under paragraph (1) may be in cash
p.000887: or in kind. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
p.000887: extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.000887: contributions.
p.000887: (3) WAIVER.—The Secretary may waive the requirement established in paragraph (1) with respect to an
p.000887: institution of higher education if the Secretary determines that extraor- dinary need at the institution
p.000887: justifies the waiver.
p.000887: (f) REPORTS.—For each fiscal year that grants are awarded under this section, the Secretary shall conduct
p.000887: a study on the re- sults of the grants and submit to the Congress a report on such re- sults that includes the
p.000887: following:
p.000887: (1) An evaluation of the grant program outcomes, includ- ing a summary of activities carried out with the grant
p.000887: and the results achieved through those activities.
p.000887: (2) Recommendations on how to improve access to mental health and substance use disorder services at
p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
p.000887: (g) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000887: section 101 of the Higher Education Act of 1965.
p.000887: (h) TECHNICAL ASSISTANCE.—The Secretary may provide tech- nical assistance to grantees in carrying out this
p.000887: section.
p.000887: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000887: to be appropriated
p.000887: $7,000,000 for each of fiscal years 2018 through 2022.
p.000887: SEC. 520E–3. ø290bb–36c¿ NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.000887: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Suicide
p.000887: Prevention Lifeline program (referred to in this section as the ‘‘program’’), authorized under section 520A
p.000887: and in effect prior to the date of enactment of the Helping Families in Mental Health Crisis Reform Act of
p.000887: 2016.
p.000887: (b) ACTIVITIES.—In maintaining the program, the activities of the Secretary shall include—
p.000887: (1) coordinating a network of crisis centers across the United States for providing suicide prevention and
p.000887: crisis inter- vention services to individuals seeking help at any time, day or night;
p.000887: (2) maintaining a suicide prevention hotline to link callers to local emergency, mental health, and social
p.000887: services re- sources; and
p.000887: (3) consulting with the Secretary of Veterans Affairs to en- sure that veterans calling the suicide prevention
...

p.000889: Assistant Sec- retary—
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p.000889: January 30, 2020
p.000889: (1) shall provide an opportunity to such practitioner to have the contact information of the practitioner
p.000889: removed from the website at the request of the practitioner; and
p.000889: (2) may evaluate other methods to periodically update the information displayed on such website.
p.000889: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prevent the Assistant Secretary from
p.000889: using any unob- ligated amounts otherwise made available to the Administration to maintain the Routing Service.
p.000889: SEC. 520F. ø290bb–37¿ STRENGTHENING COMMUNITY CRISIS RE- SPONSE SYSTEMS.
p.000889: (a) IN GENERAL.—The Secretary shall award competitive grants to—
p.000889: (1) State and local governments and Indian tribes and trib- al organizations, to enhance community-based crisis
p.000889: response systems; or
p.000889: (2) States to develop, maintain, or enhance a database of beds at inpatient psychiatric facilities, crisis
p.000889: stabilization units, and residential community mental health and residential sub- stance use disorder treatment
p.000889: facilities, for adults with a seri- ous mental illness, children with a serious emotional disturb- ance, or
p.000889: individuals with a substance use disorder.
p.000889: (b) APPLICATIONS.—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000889:
p.000889:
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p.000889: Sec. 520F PUBLIC HEALTH SERVICE ACT 890
p.000889: (1) IN GENERAL.—To receive a grant under subsection (a), an entity shall submit to the Secretary an
p.000889: application, at such time, in such manner, and containing such information as the Secretary may require.
p.000889: (2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An applica- tion for a grant under subsection (a)(1) shall include
p.000889: a plan for—
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p.000889: January 30, 2020
p.000889: (A) promoting integration and coordination between local public and private entities engaged in crisis response,
p.000889: including first responders, emergency health care pro- viders, primary care providers, law enforcement,
p.000889: court sys- tems, health care payers, social service providers, and be- havioral health providers;
p.000889: (B) developing memoranda of understanding with pub- lic and private entities to implement crisis response serv-
p.000889: ices;
p.000889: (C) addressing gaps in community resources for crisis intervention and prevention; and
p.000889: (D) developing models for minimizing hospital re- admissions, including through appropriate discharge plan-
p.000889: ning.
p.000889: (3) BEDS DATABASE PLAN.—An application for a grant under subsection (a)(2) shall include a plan
p.000889: for developing, maintaining, or enhancing a real-time, Internet-based bed database to collect,
p.000889: aggregate, and display information about beds in inpatient psychiatric facilities and crisis stabilization
p.000889: units, and residential community mental health and residen- tial substance use disorder treatment facilities to
p.000889: facilitate the identification and designation of facilities for the temporary treatment of individuals in
p.000889: mental or substance use disorder crisis.
p.000889: (c) DATABASE REQUIREMENTS.—A bed database described in this section is a database that—
p.000889: (1) includes information on inpatient psychiatric facilities, crisis stabilization units, and residential
p.000889: community mental health and residential substance use disorder facilities in the State involved, including
p.000889: contact information for the facility or unit;
p.000889: (2) provides real-time information about the number of beds available at each facility or unit and, for
p.000889: each available bed, the type of patient that may be admitted, the level of se- curity provided, and any other
p.000889: information that may be nec- essary to allow for the proper identification of appropriate fa- cilities for
p.000889: treatment of individuals in mental or substance use disorder crisis; and
p.000889: (3) enables searches of the database to identify available beds that are appropriate for the treatment
p.000889: of individuals in mental or substance use disorder crisis.
p.000889: (d) EVALUATION.—An entity receiving a grant under subsection (a)(1) shall submit to the Secretary, at such time, in
p.000889: such manner, and containing such information as the Secretary may reasonably require, a report, including an
p.000889: evaluation of the effect of such grant on—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: 891
p.000891: PUBLIC HEALTH SERVICE ACT
p.000891: Sec. 520G
p.000891:
p.000891: (1) local crisis response services and measures for individ- uals receiving crisis planning and early
p.000891: intervention supports;
p.000891: (2) individuals reporting improved functional outcomes;
p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
...

p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000891:
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
p.000891: (2) create or expand community-based mental health and co-occurring mental illness and substance use disorder
p.000891: services to accommodate the diversion program;
p.000891: (3) train professionals involved in the system of care, and law enforcement officers, attorneys, and judges;
p.000891: (4) provide community outreach and crisis intervention;
p.000891: and
p.000891: (5) develop programs to divert individuals prior to booking
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p.000891: January 30, 2020
p.000891: or arrest.
p.000891: (f) FEDERAL SHARE.—
p.000891: (1) IN GENERAL.—The Secretary shall pay to a State, polit- ical subdivision of a State, Indian tribe, or tribal
p.000891: organization receiving a grant under subsection (a) the Federal share of the cost of activities described in the
p.000891: application.
p.000891: (2) FEDERAL SHARE.—The Federal share of a grant made under this section shall not exceed 75 percent of the
p.000891: total cost of the program carried out by the State, political subdivision of a State, Indian tribe, or tribal
p.000891: organization. Such share shall be used for new expenses of the program carried out by such State, political
p.000891: subdivision of a State, Indian tribe, or tribal or- ganization.
p.000891: (3) NON-FEDERAL SHARE.—The non-Federal share of pay- ments made under this section may be made in cash or in kind
p.000891: fairly evaluated, including planned equipment or services. The Secretary may waive the requirement of matching
p.000891: contribu- tions.
...

p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
p.000895: and physical
p.000895:
p.000895:
p.000895:
p.000895:
p.000895: January 30, 2020
p.000895: 13 So in law. Words in the heading (except the first) probably should be all small caps. See section
p.000895: 3213 of Public Law 106–310 (114 Stat. 1206).
p.000895: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000895:
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p.000895: Sec. 520K PUBLIC HEALTH SERVICE ACT 896
p.000895:
p.000895: health services, which may include practices that share the same space in the same facility.
p.000895: (3) SPECIAL POPULATION.—The term ‘‘special population’’ means—
p.000895: (A) adults with a mental illness who have co-occurring physical health conditions or chronic diseases;
p.000895: (B) adults with a serious mental illness who have co- occurring physical health conditions or chronic
p.000895: diseases;
p.000895: (C) children and adolescents with a serious emotional disturbance with co-occurring physical health conditions
p.000895: or chronic diseases; or
p.000895: (D) individuals with a substance use disorder.
p.000895: (b) GRANTS AND COOPERATIVE AGREEMENTS.—
p.000895: (1) IN GENERAL.—The Secretary may award grants and co- operative agreements to eligible entities to support the
p.000895: im- provement of integrated care for primary care and behavioral health care in accordance with paragraph (2).
p.000895: (2) PURPOSES.—A grant or cooperative agreement awarded under this section shall be designed to—
p.000895: (A) promote full integration and collaboration in clin- ical practices between primary and behavioral health
p.000895: care;
p.000895: (B) support the improvement of integrated care models for primary care and behavioral health care to improve the
p.000895: overall wellness and physical health status of adults with a serious mental illness or children with a
p.000895: serious emo- tional disturbance; and
p.000895: (C) promote integrated care services related to screen- ing, diagnosis, prevention, and treatment of mental and
p.000895: substance use disorders, and co-occurring physical health conditions and chronic diseases.
p.000895: (c) APPLICATIONS.—
p.000895: (1) IN GENERAL.—An eligible entity seeking a grant or co- operative agreement under this section shall
p.000895: submit an appli- cation to the Secretary at such time, in such manner, and ac- companied by such
p.000895: information as the Secretary may require, including the contents described in paragraph (2).
p.000895: (2) CONTENTS.—The contents described in this paragraph are—
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p.000899: (2) USE OF CERTAIN FUNDS.—Of the funds appropriated to carry out this section in any fiscal year, not
p.000899: more than 5 per- cent shall be available to the Assistant Secretary for carrying out subsection (d).
p.000899: PART C—PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS
p.000899: SEC. 521. ø290cc–21¿ FORMULA GRANTS TO STATES.
p.000899: For the purpose of carrying out section 522, the Secretary, act- ing through the Director of the Center for Mental
p.000899: Health Services, shall for each of the fiscal years 2018 through 2022 make an allot- ment for each State in an
p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
p.000899: (B) providing assistance in obtaining and coordinating social and maintenance services for the eligible homeless
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000901: 901
p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
p.000901: transportation serv- ices, and habilitation and rehabilitation services, prevocational and
p.000901: vocational services, and housing serv- ices;
p.000901: (C) providing assistance to the eligible homeless indi- vidual in obtaining income support services,
p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
p.000901: benefits;
p.000901: (D) referring the eligible homeless individual for such other services as may be appropriate; and
...

p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
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p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
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p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that not more than 4 percent of the payments will be expended for ad- ministrative
p.000901: expenses regarding the payments.
p.000901: (g) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that—
p.000901: (1) not more than 20 percent of the payments will be ex- pended for housing services under subsection
p.000901: (b)(10); and
p.000901: (2) the payments will not be expended—
p.000901: (A) to support emergency shelters or construction of housing facilities;
p.000901: (B) for inpatient psychiatric treatment costs or inpa- tient substance use disorder treatment costs; or
p.000901: (C) to make cash payments to intended recipients of mental health or substance use disorder services.
p.000901: (h) WAIVER FOR TERRITORIES.—With respect to the United States Virgin Islands, Guam, American Samoa, Palau,
p.000901: the Mar- shall Islands, and the Commonwealth of the Northern Mariana Is- lands, the Secretary may waive the
p.000901: provisions of this part that the Secretary determines to be appropriate.
p.000901: SEC. 523. ø290cc–23¿ REQUIREMENT OF MATCHING FUNDS.
p.000901: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless, with respect to the
p.000901: costs of providing services pursuant to section 522, the State involved agrees to make available, directly or through
p.000901: donations from public or private enti- ties, non-Federal contributions toward such costs in an amount that is
p.000901: not less than $1 for each $3 of Federal funds provided in such payments.
p.000901: (b) DETERMINATION OF AMOUNT.—Non-Federal contributions required in subsection (a) may be in cash or in
p.000901: kind, fairly evalu- ated, including plant, equipment, or services. Amounts provided by the Federal Government, or
p.000901: services assisted or subsidized to any significant extent by the Federal Government, shall not be included in
p.000901: determining the amount of such non-Federal contributions.
p.000901: (c) LIMITATION REGARDING GRANTS BY STATES.—The Secretary may not make payments under section 521 unless the
p.000901: State in- volved agrees that the State will not require the entities to which grants are provided pursuant
p.000901: to section 522(a) to provide non-Fed- eral contributions in excess of the non-Federal contributions de- scribed
p.000901: in subsection (a).
p.000901: SEC. 524. ø290cc–24¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
...

p.000903: in, and are con-
p.000903: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000905: 905
p.000905: PUBLIC HEALTH SERVICE ACT
p.000905: Sec. 531
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p.000905: January 30, 2020
p.000905: sistent with, the State comprehensive mental health services plan referred to in paragraph (1).
p.000905: SEC. 528. ø290cc–28¿ REQUIREMENT OF REPORTS BY STATES.
p.000905: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000905: agrees that, by not later than January 31 of each fiscal year, the State will prepare and submit to
p.000905: the Secretary a report in such form and containing such information as the Secretary determines (after
p.000905: consultation with the Assistant Secretary for Mental Health and Substance Use) to be necessary for—
p.000905: (1) securing a record and a description of the purposes for which amounts received under section 521 were expended dur-
p.000905: ing the preceding fiscal year and of the recipients of such amounts; and
p.000905: (2) determining whether such amounts were expended in accordance with the provisions of this part.
p.000905: (b) AVAILABILITY TO PUBLIC OF REPORTS.—The Secretary may not make payments under section 521 unless the
p.000905: State involved agrees to make copies of the reports described in subsection (a) available for public
p.000905: inspection.
p.000905: (c) EVALUATIONS BY COMPTROLLER GENERAL.—The Assistant Secretary for Mental Health and Substance Use
p.000905: shall evaluate at least once every 3 years the expenditures of grants under this part by eligible entities in
p.000905: order to ensure that expenditures are con- sistent with the provisions of this part, and shall include
p.000905: in such evaluation recommendations regarding changes needed in program design or operations.
p.000905: SEC. 529. ø290cc–29¿ REQUIREMENT OF APPLICATION.
p.000905: The Secretary may not make payments under section 521 un- less the State involved—
p.000905: (1) submits to the Secretary an application for the pay- ments containing agreements and information in
p.000905: accordance with this part;
p.000905: (2) the agreements are made through certification from the chief executive officer of the State; and
p.000905: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.000905: assurances, and information as the Secretary determines to be necessary to carry out this part.
...

p.000907: for providing each State with an allotment under section 521 of not less than the applicable amount under section
p.000907: 524(a)(1), the Secretary shall, from such amounts as are made available under such subsection, make grants
p.000907: to the States for providing to eligible homeless individuals the services specified in section 522(b).
p.000907: (2) RULE OF CONSTRUCTION.—Paragraph (1) may not be construed to require the Secretary to make a grant under such
p.000907: paragraph to each State.
p.000907: PART D—MISCELLANEOUS PROVISIONS RELATING TO SUBSTANCE ABUSE AND MENTAL HEALTH
p.000907: SEC. 541. ø290dd¿ SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
p.000907: (a) PROGRAMS AND SERVICES.—
p.000907: (1) DEVELOPMENT.—The Secretary, acting through the As- sistant Secretary for Mental Health and Substance
p.000907: Use, shall be responsible for fostering substance abuse prevention and treatment programs and services in
p.000907: State and local govern- ments and in private industry.
p.000907: (2) MODEL PROGRAMS.—
p.000907: (A) IN GENERAL.—Consistent with the responsibilities described in paragraph (1), the Secretary, acting
p.000907: through the Assistant Secretary for Mental Health and Substance Use, shall develop a variety of model programs
p.000907: suitable for replication on a cost-effective basis in different types of business concerns and State and
p.000907: local governmental enti- ties.
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p.000907: January 30, 2020
p.000907: (B) DISSEMINATION OF INFORMATION.—The Secretary, acting through the Assistant Secretary for Mental Health
p.000907: and Substance Use, shall disseminate information and ma- terials relative to such model programs to the State agen-
p.000907: cies responsible for the administration of substance abuse prevention, treatment, and rehabilitation
p.000907: activities and shall, to the extent feasible provide technical assistance to such agencies as requested.
p.000907: (b) DEPRIVATION OF EMPLOYMENT.—
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000909: 909
p.000909: PUBLIC HEALTH SERVICE ACT
p.000909: Sec. 542
p.000909:
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p.000909: January 30, 2020
p.000909: (1) PROHIBITION.—No person may be denied or deprived of Federal civilian employment or a Federal professional or other
p.000909: license or right solely on the grounds of prior substance abuse.
...

p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
p.000911: to this subsection, the Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of
p.000911: Health and Human Services in order to achieve the maximum possible coordination of the regu- lations, and the
p.000911: implementation thereof, which they each prescribe.
p.000911: SEC. 543A. ø290dd–2a¿ PROMOTING ACCESS TO INFORMATION ON EVI- DENCE-BASED PROGRAMS AND PRACTICES.
p.000911: (a) IN GENERAL.—The Assistant Secretary shall, as appro- priate, improve access to reliable and valid
p.000911: information on evi- dence-based programs and practices, including information on the strength of evidence
p.000911: associated with such programs and practices, related to mental and substance use disorders for States, local com-
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: Sec. 544 PUBLIC HEALTH SERVICE ACT 912
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p.000911: January 30, 2020
p.000911:
p.000911: munities, nonprofit entities, and other stakeholders, by posting on the Internet website of the Administration
p.000911: information on evidence- based programs and practices that have been reviewed by the As- sistant Secretary
p.000911: in accordance with the requirements of this sec- tion.
p.000911: (b) APPLICATIONS.—
p.000911: (1) APPLICATION PERIOD.—In carrying out subsection (a), the Assistant Secretary may establish a period for the
p.000911: submis- sion of applications for evidence-based programs and practices to be posted publicly in accordance with
p.000911: subsection (a).
p.000911: (2) NOTICE.—In establishing the application period under paragraph (1), the Assistant Secretary shall
...

p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
p.000917: organization that—
p.000917: (1) mobilizes resources within and outside of the recovery community, which may include through a peer
p.000917: support net- work, to increase the prevalence and quality of long-term re- covery from substance use
p.000917: disorders; and
p.000917: (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community
p.000917: served.
p.000917: (b) GRANTS AUTHORIZED.—The Secretary shall award grants to recovery community organizations to enable such
p.000917: organizations to develop, expand, and enhance recovery services.
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000917:
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p.000917: Sec. 547A PUBLIC HEALTH SERVICE ACT 918
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p.000917:
p.000917: (c) FEDERAL SHARE.—The Federal share of the costs of a pro- gram funded by a grant under this section may not
p.000917: exceed 85 per- cent.
p.000917: (d) USE OF FUNDS.—Grants awarded under subsection (b)—
p.000917: (1) shall be used to develop, expand, and enhance commu- nity and statewide recovery support services; and
p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
p.000917: each of fis- cal years 2019 through 2023.
p.000917: SEC. 547A. ø290ee–2a¿ PEER SUPPORT TECHNICAL ASSISTANCE CEN- TER.
p.000917: (a) ESTABLISHMENT.—The Secretary, acting through the Assist- ant Secretary, shall establish or operate a
p.000917: National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this
p.000917: section as the ‘‘Center’’).
p.000917: (b) FUNCTIONS.—The Center established under subsection (a) shall provide technical assistance and support
p.000917: to recovery commu- nity organizations and peer support networks, including such as- sistance and support
p.000917: related to—
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: 919
p.000919: PUBLIC HEALTH SERVICE ACT
p.000919: Sec. 548
p.000919:
p.000919: (1) training on identifying—
p.000919: (A) signs of substance use disorder;
p.000919: (B) resources to assist individuals with a substance use disorder, or resources for families of an individual
p.000919: with a substance use disorder; and
p.000919: (C) best practices for the delivery of recovery support services;
p.000919: (2) the provision of translation services, interpretation, or other such services for clients with limited
p.000919: English speaking proficiency;
p.000919: (3) data collection to support research, including for translational research;
p.000919: (4) capacity building; and
p.000919: (5) evaluation and improvement, as necessary, of the effec- tiveness of such services provided by recovery community
p.000919: orga- nizations.
p.000919: (c) BEST PRACTICES.—The Center established under subsection
p.000919: (a) shall periodically issue best practices for use by recovery com- munity organizations and peer support
p.000919: networks.
p.000919: (d) RECOVERY COMMUNITY ORGANIZATION.—In this section, the term ‘‘recovery community organization’’ has the
p.000919: meaning given such term in section 547.
p.000919: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000919: $1,000,000 for each of fiscal years 2019 through 2023.
p.000919: SEC. 548. ø290ee–3¿ STATE DEMONSTRATION GRANTS FOR COM- PREHENSIVE OPIOID ABUSE RESPONSE.
p.000919: (a) DEFINITIONS.—In this section:
p.000919: (1) DISPENSER.—The term ‘‘dispenser’’ has the meaning given the term in section 102 of the Controlled Substances
p.000919: Act (21 U.S.C. 802).
p.000919: (2) PRESCRIBER.—The term ‘‘prescriber’’ means a dispenser who prescribes a controlled substance, or the agent
p.000919: of such a dispenser.
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p.000923: (6) State and local law enforcement agencies;
p.000923: (7) health insurance issuers;
p.000923: (8) recovery housing entities; and
p.000923: (9) the public.
p.000923: (d) REQUIREMENTS.—In carrying out the activities described in subsections (a) and (b), the Secretary, in
p.000923: consultation with appro- priate individuals and entities described in subsections (a)(2) and (b)(2), shall
p.000923: consider how recovery housing is able to support recov- ery and prevent relapse, recidivism, or overdose (including
p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
p.000925: Disorder Education for purposes of im- proving health professional training resources with respect to sub- stance
p.000925: use disorder prevention, treatment, and recovery.
p.000925: (b) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under subsection (a), an entity shall—
p.000925: (1) be an accredited entity that offers education to students in various health professions, which may include—
p.000925: (A) a teaching hospital;
p.000925: (B) a medical school;
p.000925: (C) a certified behavioral health clinic; or
p.000925: (D) any other health professions school, school of pub- lic health, or Cooperative Extension Program at institu-
p.000925: tions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in
p.000925: the prevention, treatment, or recovery of substance use disorders;
p.000925: (2) demonstrate community engagement and partnerships with community stakeholders, including entities
p.000925: that train health professionals, mental health counselors, social workers, peer recovery specialists,
p.000925: substance use treatment programs, community health centers, physician offices, certified behav- ioral health
p.000925: clinics, research institutions, and law enforcement; and
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p.000925: (3) submit to the Secretary an application containing such information, at such time, and in such manner, as
p.000925: the Sec- retary may require.
p.000925: (c) ACTIVITIES.—An entity receiving an award under this sec- tion shall develop, evaluate, and
p.000925: distribute evidence-based re- sources regarding the prevention and treatment of, and recovery from,
p.000925: substance use disorders. Such resources may include informa- tion on—
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: Sec. 552 PUBLIC HEALTH SERVICE ACT 926
p.000925:
p.000925: (1) the neurology and pathology of substance use disorders;
p.000925: (2) advancements in the treatment of substance use dis- orders;
p.000925: (3) techniques and best practices to support recovery from substance use disorders;
p.000925: (4) strategies for the prevention and treatment of, and re- covery from substance use disorders across patient
p.000925: populations; and
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p.000925: (5) other topic areas that are relevant to the objectives de- scribed in subsection (a).
p.000925: (d) GEOGRAPHIC DISTRIBUTION.—In awarding cooperative agreements under subsection (a), the Secretary
p.000925: shall take into ac- count regional differences among eligible entities and shall make an effort to ensure
p.000925: geographic distribution.
p.000925: (e) EVALUATION.—The Secretary shall evaluate each project carried out by an entity receiving an award under this
p.000925: section and shall disseminate the findings with respect to each such evaluation to appropriate public and private
p.000925: entities.
p.000925: (f) FUNDING.—There is authorized to be appropriated to carry out this section, $4,000,000 for each of
p.000925: fiscal years 2019 through 2023.
p.000925: SEC. 552. ø290ee–7¿ COMPREHENSIVE OPIOID RECOVERY CENTERS.
p.000925: (a) IN GENERAL.—The Secretary shall award grants on a com- petitive basis to eligible entities to establish or
p.000925: operate a com- prehensive opioid recovery center (referred to in this section as a ‘‘Center’’). A Center
p.000925: may be a single entity or an integrated deliv- ery network.
p.000925: (b) GRANT PERIOD.—
p.000925: (1) IN GENERAL.—A grant awarded under subsection (a) shall be for a period of not less than 3 years and not more
p.000925: than 5 years.
p.000925: (2) RENEWAL.—A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional
p.000925: periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph,
p.000925: the Secretary shall consider the data submitted under subsection (h).
p.000925: (c) MINIMUM NUMBER OF CENTERS.—The Secretary shall allo- cate the amounts made available under subsection (j)
p.000925: such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a
p.000925: single State for any one period.
p.000925: (d) APPLICATION.—
p.000925: (1) ELIGIBLE ENTITY.—An entity is eligible for a grant under this section if the entity offers treatment and
p.000925: other serv- ices for individuals with a substance use disorder.
p.000925: (2) SUBMISSION OF APPLICATION.—In order to be eligible for a grant under subsection (a), an entity shall
p.000925: submit an applica- tion to the Secretary at such time and in such manner as the Secretary may require. Such
p.000925: application shall include—
p.000925: (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activi-
p.000925: ties described in subsection (g); and
p.000925: (B) such other information as the Secretary may re- quire.
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: 927
p.000927: PUBLIC HEALTH SERVICE ACT
p.000927: Sec. 552
p.000927:
p.000927: (e) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to eligible entities—
p.000927: (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national
p.000927: overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or
p.000927: (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education
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p.000927: (1) TREATMENT AND RECOVERY SERVICES.—Each Center shall—
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p.000927: (A) Ensure that intake, evaluations, and periodic pa- tient assessments meet the individualized clinical needs
p.000927: of patients, including by reviewing patient placement in treatment settings to support meaningful recovery.
p.000927: (B) Provide the full continuum of treatment services, including—
p.000927: (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all bio- logical
p.000927: products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant
p.000927: to Federal and State law;
p.000927: (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and
p.000927: readiness for and entry into treatment;
p.000927: (iii) counseling provided by a program counselor or other certified professional who is licensed and quali- fied
p.000927: by education, training, or experience to assess the psychological and sociological background of patients, to
p.000927: contribute to the appropriate treatment plan for the patient, and to monitor patient progress;
p.000927: (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders;
p.000927: (v) testing, as appropriate, for infections com- monly associated with illicit drug use;
p.000927: (vi) residential rehabilitation, and outpatient and intensive outpatient programs;
p.000927: (vii) recovery housing;
p.000927: (viii) community-based and peer recovery support services;
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
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p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
p.000927: (h) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant awarded under subsection (a), not later
p.000927: than 90 days after the end of the first year of the grant period, and annually thereafter for the
p.000927: duration of the grant period (including the dura- tion of any renewal period for such grant), the entity shall submit
p.000927: data, as appropriate, to the Secretary regarding—
p.000927: (1) the programs and activities funded by the grant;
p.000927: (2) health outcomes of the population of individuals with a substance use disorder who received services
p.000927: from the Cen-
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000929: 929
p.000929: PUBLIC HEALTH SERVICE ACT
p.000929: Sec. 561
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p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
p.000951: National Center on Substance Abuse and Child Welfare.
p.000951: TITLE VI—ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000951: DECLARATION OF PURPOSE
p.000951: SEC. 600. ø291¿ The purpose of this title is—
p.000951: (a) to assist the several States in the carrying out of their programs for the construction and modernization of such
p.000951: public or other nonprofit community hospitals and other medical fa- cilities as may be necessary, in
p.000951: conjunction with existing facili-
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p.000951: January 30, 2020
p.000951: 24 Placement of section 550 is so in law. Section 8214 of Public Law 115-271 inserted a second section 550 at the end
p.000951: of title V.
p.000951: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: ment), and safe disposal options for prescription medications (including such options provided by law
p.001051: enforcement or other innovative deactivation mechanisms).
p.001051: (c) EVALUATION OF PROGRAMS.—The Secretary shall (directly or through grants or contracts) provide for
p.001051: the evaluation of pro- grams implemented under subsection (a) in order to determine the effect of such programs on
p.001051: knowledge and practice of pain care.
p.001051: (d) PAIN CARE DEFINED.—For purposes of this section the term ‘‘pain care’’ means the assessment, diagnosis,
p.001051: prevention, treat- ment, or management of acute or chronic pain regardless of causa- tion or body location.
p.001051: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001051: such sums as may be necessary for each of the fiscal years 2019 through 2023. Amounts appropriated under this
p.001051: subsection shall remain available until ex- pended.
p.001051: SEC. 760. ø294k¿ TRAINING DEMONSTRATION PROGRAM.
p.001051: (a) IN GENERAL.—The Secretary shall establish a training dem- onstration program to award grants to eligible entities
p.001051: to support—
p.001051: (1) training for medical residents and fellows to practice psychiatry and addiction medicine in underserved,
p.001051: community- based settings that integrate primary care with mental and substance use disorders prevention and
p.001051: treatment services;
p.001051: (2) training for nurse practitioners, physician assistants, health service psychologists, and social workers
p.001051: to provide mental and substance use disorders services in underserved community-based settings that
p.001051: integrate primary care and mental and substance use disorders services; and
p.001051: (3) establishing, maintaining, or improving academic units or programs that—
p.001051: (A) provide training for students or faculty, including through clinical experiences and research, to
p.001051: improve the ability to be able to recognize, diagnose, and treat mental and substance use disorders, with a
p.001051: special focus on addic- tion; or
p.001051: (B) develop evidence-based practices or recommenda- tions for the design of the units or programs
p.001051: described in subparagraph (A), including curriculum content standards.
p.001051: (b) ACTIVITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—A recipient of a grant under subsection (a)(1)—
p.001051: (A) shall use the grant funds—
p.001051: (i)(I) to plan, develop, and operate a training pro- gram for medical psychiatry residents and fellows
p.001051: in addiction medicine practicing in eligible entities de- scribed in subsection (c)(1); or
p.001051: (II) to train new psychiatric residents and fellows in addiction medicine to provide and expand access to
p.001051: integrated mental and substance use disorders serv- ices; and
p.001051: (ii) to provide at least 1 training track that is—
p.001051: (I) a virtual training track that includes an in-person rotation at a teaching health center or
p.001051: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: Sec. 760 PUBLIC HEALTH SERVICE ACT 1052
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p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
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p.001067: (d) WORK OBLIGATION.—Participation in fellowship training programs under this section shall be deemed to be
p.001067: service for pur- poses of satisfying work obligations stipulated in contracts under section 338I(j).
p.001067: (e) GENERAL SUPPORT.—Amounts may be used from grants awarded under this section to expand the
p.001067: Public Health Informatics Fellowship Program at the Centers for Disease Control and Prevention to better
p.001067: support all public health systems at all levels of government.
p.001067: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $39,500,000
p.001067: for each of fiscal years 2010 through 2013, of which—
p.001067: (1) $5,000,000 shall be made available in each such fiscal year for epidemiology fellowship training
p.001067: program activities under subsections (b) and (c);
p.001067: (2) $5,000,000 shall be made available in each such fiscal year for laboratory fellowship training
p.001067: programs under sub- section (b);
p.001067: (3) $5,000,000 shall be made available in each such fiscal year for the Public Health Informatics
p.001067: Fellowship Program under subsection (e); and
p.001067: (4) $24,500,000 shall be made available for expanding the Epidemic Intelligence Service under subsection (a).
p.001067: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001069: 1069
p.001069: PUBLIC HEALTH SERVICE ACT
p.001069:
p.001069: PART F—SUBSTANCE USE DISORDER TREATMENT WORKFORCE
p.001069: Sec. 781
p.001069:
p.001069: SEC. 781. ø295h¿ LOAN REPAYMENT PROGRAM FOR SUBSTANCE USE DISORDER TREATMENT WORKFORCE.
p.001069: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001069: Administration, shall carry out a program under which—
p.001069: (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection
p.001069: (b) on the principal of and interest on any eligible loan; and
p.001069: (2) the individuals each agree to the requirements of serv- ice in substance use disorder treatment employment,
p.001069: as de- scribed in subsection (d).
p.001069: (b) PAYMENTS.—For each year of obligated service by an indi- vidual pursuant to an agreement under
p.001069: subsection (a), the Sec- retary shall make a payment to such individual as follows:
p.001069: (1) SERVICE IN A SHORTAGE AREA.—The Secretary shall pay—
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p.001069: (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1⁄6 of
p.001069: the principal of and interest on each eligible loan of the indi- vidual which is outstanding on the
p.001069: date the individual began service pursuant to the agreement; and
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p.001069: (2) shall give notice to the committees specified in sub- section (h) of any criteria and rules so
p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001071: 1071
p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
p.001071: center-affili- ated treatment program), correctional facility or program, youth detention center or program,
p.001071: inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or
p.001071: other specialty community be- havioral health center, recovery center, school, community- based organization,
p.001071: telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal
p.001071: organization, Federal medical facility, or any other facility as determined appropriate for purposes of this
p.001071: section by the Secretary.
p.001071: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $25,000,000
p.001071: for each of fiscal years 2019 through 2023.
p.001071: PART G—GENERAL PROVISIONS
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p.001071: January 30, 2020
p.001071: SEC. 791. ø295j¿ PREFERENCES AND REQUIRED INFORMATION IN CER- TAIN PROGRAMS.
p.001071: (a) PREFERENCES IN MAKING AWARDS.—
p.001071: (1) IN GENERAL.—Subject to paragraph (2), in making awards of grants or contracts under any of
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p.001279: care providers. The imple- mentation of the national program shall begin during fiscal year 1999.
p.001279: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001279: to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The
p.001279: authorization of appropriations established in the preceding sentence is in addition to any other authorization of
p.001279: appropriation that is available for such purpose.
p.001279: SEC. 1711. ø300u–16¿ ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION DASHBOARD.
p.001279: (a) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Secretary of Health
p.001279: and Human Services shall, in consultation with the Director of National Drug Control Policy, establish
p.001279: and periodically update, on the Internet website of the Department of Health and Human Services, a public
p.001279: information dashboard that—
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001279: Sec. 1801 PUBLIC HEALTH SERVICE ACT 1280
p.001279:
p.001279: (1) provides links to information on programs within the Department of Health and Human Services related
p.001279: to the re- duction of opioid and other substance use disorders;
p.001279: (2) provides access, to the extent practicable and appro- priate, to publicly available data, which may include
p.001279: data from agencies within the Department of Health and Human Serv- ices and—
p.001279: (A) other Federal agencies;
p.001279: (B) State, local, and Tribal governments;
p.001279: (C) nonprofit organizations;
p.001279: (D) law enforcement;
p.001279: (E) medical experts;
p.001279: (F) public health educators; and
p.001279: (G) research institutions regarding prevention, treat- ment, recovery, and other services for opioid and
p.001279: other substance use disorders;
p.001279: (3) provides data on substance use disorder prevention and treatment strategies in different regions of and
p.001279: populations in the United States;
p.001279: (4) identifies information on alternatives to controlled sub- stances for pain management, such as approaches
p.001279: studied by the National Institutes of Health Pain Consortium, the Na- tional Center for Complimentary and
p.001279: Integrative Health, and other institutes and centers at the National Institutes of Health, as
p.001279: appropriate; and
p.001279: (5) identifies guidelines and best practices for health care providers regarding treatment of substance use
p.001279: disorders.
p.001279: (b) CONTROLLED SUBSTANCE DEFINED.—In this section, the term ‘‘controlled substance’’ has the meaning
p.001279: given that term in section 102 of the Controlled Substances Act (21 U.S.C. 802).
p.001279: TITLE XVIII—PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND
p.001279: BEHAVIORAL RESEARCH
p.001279: ESTABLISHMENT OF COMMISSION
p.001279: SEC. 1801. ø300v¿ (a) ESTABLISHMENT.—(1) There is estab-
p.001279: lished the President’s Commission for the Study of Ethical Prob- lems in Medicine and Biomedical and
p.001279: Behavioral Research 1 (here- inafter in this title referred to as the ‘‘Commission’’) which shall be composed of
p.001279: eleven members appointed by the President. The mem- bers of the Commission shall be appointed as follows:
p.001279: (A) Three of the members shall be appointed from individ- uals who are distinguished in biomedical or behavioral
p.001279: re- search.
p.001279: (B) Three of the members shall be appointed from individ- uals who are distinguished in the practice of medicine or
p.001279: other- wise distinguished in the provision of health care.
p.001279: (C) Five of the members shall be appointed from individ- uals who are distinguished in one or more of the
p.001279: fields of eth-
p.001279:
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p.001279: January 30, 2020
p.001279: 1 Such a Commission was established on December 17, 1979, by Executive Order No. 12184 (44 Fed. Reg.
p.001279: 75091). The Executive Order was revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed. Reg.
p.001279: 7237).
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
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p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: Sec. 1912 PUBLIC HEALTH SERVICE ACT 1298
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p.001297:
p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
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p.001307: (2) STATE FLEXIBILITY.—In lieu of expending 10 percent of the amount the State receives under this section for
p.001307: a fiscal year as required under paragraph (1), a State may elect to ex- pend not less than 20 percent of such
p.001307: amount by the end of such succeeding fiscal year.
p.001307:
p.001307: Subpart II—Block Grants for Prevention and Treatment of Substance Abuse
p.001307:
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p.001307: January 30, 2020
p.001307: SEC. 1921. ø300x–21¿ FORMULA GRANTS TO STATES.
p.001307: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Center for
p.001307: Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in
p.001307: accordance with section 1933. The Sec- retary shall make a grant to the State of the allotment made for the
p.001307: State for the fiscal year if the State submits to the Secretary an application in accordance with section
p.001307: 1932.
p.001307: (b) AUTHORIZED ACTIVITIES.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001307: 1931, the State in- volved will expend the grant only for the purpose of carrying out the plan developed
p.001307: in accordance with section 1932(b) and for plan- ning, carrying out, and evaluating activities to prevent and
p.001307: treat substance use disorders and for related activities authorized in sec- tion 1924.
p.001307: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
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p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
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p.001309: individuals to the program, provide to the State a notification of such fact.
p.001309: (2) PROVISION OF TREATMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001309: will, with respect to notifications under paragraph (1), ensure that each individual who requests and is
p.001309: in need of treatment for intra- venous drug abuse is admitted to a program of such treatment not later than—
p.001309: (A) 14 days after making the request for admission to such a program; or
p.001309: (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on
p.001309: the date of such request and if interim services are made available to the individual not later than 48
p.001309: hours after such request.
p.001309: (b) OUTREACH TO PERSONS WHO INJECT DRUGS.—A funding agreement for a grant under section 1921 is
p.001309: that the State in- volved, in providing amounts from the grant to any entity for treat- ment services for persons
p.001309: who inject drugs, will require the entity to carry out activities to encourage individuals in need of
p.001309: such treatment to undergo treatment.
p.001309: SEC. 1924. ø300x–24¿ REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN IMMUNODEFICIENCY VIRUS.
p.001309: (a) TUBERCULOSIS.—
p.001309: (1) IN GENERAL.—A funding agreement for a grant under section 1921 is that the State involved will
p.001309: require that any entity receiving amounts from the grant for operating a pro- gram of treatment for
p.001309: substance use disorders—
p.001309: (A) will, directly or through arrangements with other public or nonprofit private entities, routinely make
p.001309: avail-
p.001309: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001311: 1311
p.001311: PUBLIC HEALTH SERVICE ACT
p.001311: Sec. 1924
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p.001311: able tuberculosis services to each individual receiving treatment for such disorders; and
p.001311: (B) in the case of an individual in need of such treat- ment who is denied admission to the program on the
p.001311: basis of the lack of the capacity of the program to admit the in- dividual, will refer the individual to another
p.001311: provider of tu- berculosis services.
p.001311: (2) TUBERCULOSIS SERVICES.—For purposes of paragraph (1), the term ‘‘tuberculosis services’’, with
p.001311: respect to an indi- vidual, means—
p.001311: (A) counseling the individual with respect to tuber- culosis;
p.001311: (B) testing to determine whether the individual has contracted such disease and testing to determine the form of
p.001311: treatment for the disease that is appropriate for the in- dividual; and
p.001311: (C) providing such treatment to the individual.
p.001311: (b) HUMAN IMMUNODEFICIENCY VIRUS.—
p.001311: (1) REQUIREMENT FOR CERTAIN STATES.—In the case of a State described in paragraph (2), a funding
p.001311: agreement for a grant under section 1921 is that—
p.001311: (A) with respect to individuals undergoing treatment for substance use disorders, the State will, subject to
p.001311: para- graph (3), carry out 1 or more projects to make available to the individuals early intervention
p.001311: services for HIV dis- ease at the sites at which the individuals are undergoing such treatment;
p.001311: (B) for the purpose of providing such early interven- tion services through such projects, the State
p.001311: will make available from the grant the percentage that is applicable for the State under paragraph (4); and
p.001311: (C) the State will, subject to paragraph (5), carry out such projects only in geographic areas of the
p.001311: State that have the greatest need for the projects.
p.001311: (2) DESIGNATED STATES.—For purposes of this subsection, a State described in this paragraph is any State
p.001311: whose rate of cases of acquired immune deficiency syndrome is 10 or more such cases per 100,000 individuals
p.001311: (as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control
p.001311: and Prevention for the most recent calendar year for which such data are available).
p.001311: (3) USE OF EXISTING PROGRAMS REGARDING SUBSTANCE USE DISORDERS.—With respect to programs that provide
p.001311: treatment services for substance use disorders, a funding agreement for a grant under section 1921 for a
p.001311: designated State is that each such program participating in a project under paragraph (1) will be a program
p.001311: that began operation prior to the fiscal year for which the State is applying to receive the grant. A program that so
...

p.001311: (A) for a designated State for a fiscal year is less than 2 percent (including a negative percentage,
p.001311: in the case of a State for which there is no increase for purposes of such subparagraph), the percentage
p.001311: applicable under this para- graph for the State is 2 percent. If the percentage so deter- mined is 2 percent or
p.001311: more, the percentage applicable under this paragraph for the State is the percentage deter- mined under subparagraph
p.001311: (A), subject to not exceeding 5 percent.
p.001311: (5) REQUIREMENT REGARDING RURAL AREAS.—
p.001311: (A) A funding agreement for a grant under section 1921 for a designated State is that, if the State will carry
p.001311: out 2 or more projects under paragraph (1), the State will carry out 1 such project in a rural area of the
p.001311: State, sub- ject to subparagraph (B).
p.001311: (B) The Secretary shall waive the requirement estab- lished in subparagraph (A) if the State involved certifies
p.001311: to the Secretary that—
p.001311: (i) there is insufficient demand in the State to carry out a project under paragraph (1) in any rural
p.001311: area of the State; or
p.001311: (ii) there are no rural areas in the State.
p.001311: (6) MANNER OF PROVIDING SERVICES.—With respect to the provision of early intervention services for HIV
p.001311: disease to an individual, a funding agreement for a grant under section 1921 for a designated State is that—
p.001311: (A) such services will be undertaken voluntarily by, and with the informed consent of, the individual; and
p.001311: (B) undergoing such services will not be required as a condition of receiving treatment services for substance use
p.001311: disorders or any other services.
p.001311: (7) DEFINITIONS.—For purposes of this subsection:
p.001311: (A) The term ‘‘designated State’’ means a State de- scribed in paragraph (2).
p.001311: (B) The term ‘‘early intervention services’’, with re- spect to HIV disease, means—
p.001311: (i) appropriate pretest counseling;
p.001311: (ii) testing individuals with respect to such dis- ease, including tests to confirm the presence of the dis-
p.001311: ease, tests to diagnose the extent of the deficiency in the immune system, and tests to provide
p.001311: information on appropriate therapeutic measures for preventing
p.001311: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001313: 1313
p.001313: PUBLIC HEALTH SERVICE ACT
p.001313: Sec. 1925
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p.001313: and treating the deterioration of the immune system and for preventing and treating conditions
p.001313: arising from the disease;
p.001313: (iii) appropriate post-test counseling; and
p.001313: (iv) providing the therapeutic measures described in clause (ii).
p.001313: (C) The term ‘‘HIV disease’’ means infection with the etiologic agent for acquired immune deficiency
p.001313: syndrome.
p.001313: (c) EXPENDITURE OF GRANT FOR COMPLIANCE WITH AGREE-
p.001313: MENTS.—
p.001313: (1) IN GENERAL.—A grant under section 1921 may be ex- pended for purposes of compliance with the
p.001313: agreements re- quired in this section, subject to paragraph (2).
p.001313: (2) LIMITATION.—A funding agreement for a grant under section 1921 for a State is that the grant will not be
p.001313: expended to make payment for any service provided for purposes of com- pliance with this section to the extent
p.001313: that payment has been made, or can reasonably be expected to be made, with respect to such service—
p.001313: (A) under any State compensation program, under any insurance policy, or under any Federal or State health
p.001313: benefits program (including the program established in title XVIII of the Social Security Act and the
p.001313: program es- tablished in title XIX of such Act); or
p.001313: (B) by an entity that provides health services on a pre- paid basis.
p.001313: (d) APPLICABILITY OF CERTAIN PROVISION.—Section 1931 ap- plies to this section (and to each other
p.001313: provision of this subpart).
p.001313: SEC. 1925. ø300x–25¿ GROUP HOMES FOR PERSONS IN RECOVERY FROM SUBSTANCE USE DISORDERS.
p.001313: (a) STATE REVOLVING FUNDS FOR ESTABLISHMENT OF HOMES.— A State, using funds available under section 1921,
p.001313: may establish and maintain the ongoing operation of a revolving fund in accord- ance with this section to
p.001313: support group homes for persons in recov- ery from substance use disorders as follows:
p.001313: (1) The purpose of the fund is to make loans for the costs of establishing programs for the provision of housing in
p.001313: which individuals recovering from alcohol or drug abuse may reside in groups of not less than 6
p.001313: individuals. The fund is estab- lished directly by the State or through the provision of a grant or contract to a
p.001313: nonprofit private entity.
p.001313: (2) The programs are carried out in accordance with guide- lines issued under subsection (b).
p.001313: (3) Not less than $100,000 is available for the fund.
p.001313: (4) Loans made from the revolving fund do not exceed
p.001313: $4,000 and each such loan is repaid to the revolving fund by the residents of the housing involved not
p.001313: later than 2 years after the date on which the loan is made.
p.001313: (5) Each such loan is repaid by such residents through monthly installments, and a reasonable penalty is
p.001313: assessed for each failure to pay such periodic installments by the date spec- ified in the loan agreement involved.
p.001313: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001313: Sec. 1926 PUBLIC HEALTH SERVICE ACT 1314
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p.001317: carrying out subsection (a)(1)—
p.001317: (1) the State involved will require that, in the event that a treatment facility has insufficient
p.001317: capacity to provide treat- ment services to any woman described in such subsection who seeks the services from
p.001317: the facility, the facility refer the woman to the State; and
p.001317: (2) the State, in the case of each woman for whom a refer- ral under paragraph (1) is made to the State—
p.001317: (A) will refer the woman to a treatment facility that has the capacity to provide treatment
p.001317: services to the woman; or
p.001317: (B) will, if no treatment facility has the capacity to admit the woman, make interim services available
p.001317: to the woman not later than 48 hours after the women 6 seeks the treatment services.
p.001317: SEC. 1928. ø300x–28¿ ADDITIONAL AGREEMENTS.
p.001317: (a) IMPROVEMENT OF PROCESS FOR APPROPRIATE REFERRALS FOR TREATMENT.—With respect to individuals
p.001317: seeking treatment services, a funding agreement for a grant under section 1921 is that the State involved
p.001317: will improve the process in the State for re- ferring the individuals to treatment facilities that can provide
p.001317: to the individuals the treatment modality that is most appropriate for the individuals.
p.001317: (b) PROFESSIONAL DEVELOPMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001317: will ensure that prevention, treatment, and recovery personnel operating in the State’s substance use disorder
p.001317: prevention, treatment, and recovery systems have an opportunity to receive training, on an ongoing basis,
p.001317: concerning—
p.001317: (1) recent trends in substance use disorders in the State;
p.001317: (2) improved methods and evidence-based practices for pro- viding substance use disorder prevention and treatment
p.001317: serv- ices;
p.001317: (3) performance-based accountability;
p.001317: (4) data collection and reporting requirements; and
p.001317: (5) any other matters that would serve to further improve the delivery of substance use disorder prevention and
p.001317: treat- ment services within the State.
p.001317: (c) COORDINATION OF VARIOUS ACTIVITIES AND SERVICES.—A funding agreement for a grant under section 1921 is
p.001317: that the State involved will coordinate prevention and treatment activities with the provision of other
p.001317: appropriate services (including health, social, correctional and criminal justice, educational, vocational rehabilita-
p.001317: tion, and employment services).
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p.001317: January 30, 2020
p.001317: 6 So in law. See section 202 of Public Law 102–321 (106 Stat. 396). Probably should be ‘‘woman’’.
p.001317: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: Sec. 1930 PUBLIC HEALTH SERVICE ACT 1318
p.001317:
p.001317: (d) 8 WAIVER OF REQUIREMENT.—
p.001317: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may provide to a State a waiver of any or all of
p.001317: the re- quirements established in this section if the Secretary deter- mines that, with respect to
p.001317: services for the prevention and treatment of substance use disorders, the requirement involved is unnecessary for
p.001317: maintaining quality in the provision of such services in the State.
p.001317: (2) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001317: under para- graph (1) not later than 120 days after the date on which the request is made.
p.001317: (3) APPLICABILITY OF WAIVER.—Any waiver provided by the Secretary under paragraph (1) shall be applicable only
p.001317: to the fiscal year involved.
p.001317: øSection 1929 was repealed by section 8002(f) of Public Law 114–255.¿
p.001317: SEC. 1930. ø300x–30¿ MAINTENANCE OF EFFORT REGARDING STATE EX- PENDITURES.
p.001317: (a) IN GENERAL.—With respect to the principal agency of a State for carrying out authorized activities,
p.001317: a funding agreement for a grant under section 1921 for the State for a fiscal year is that such agency will for
p.001317: such year maintain aggregate State expendi- tures for authorized activities at a level that is not less
p.001317: than the average level of such expenditures maintained by the State for the 2-year period preceding the fiscal year
p.001317: for which the State is apply- ing for the grant.
p.001317: (b) EXCLUSION OF CERTAIN FUNDS.—The Secretary may ex- clude from the aggregate State expenditures under
p.001317: subsection (a), funds appropriated to the principle agency for authorized activities which are of a non-recurring
p.001317: nature and for a specific purpose.
p.001317: (c) WAIVER.—
p.001317: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may waive all or part of the requirement
p.001317: established in subsection (a) if the Secretary determines that extraordinary economic conditions exist in the
p.001317: State, or any part of the State, to justify the waiver.
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p.001321: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001321: Secretary;
p.001321: (5) the application contains the report required in section 1942(a);
p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
p.001321: (ix) describes how the State integrates substance use disorder services and primary health care, which in
p.001321: the case of those individuals with co-occurring men- tal health and substance use disorders may include
p.001321: providing both mental health and substance use dis- order services in primary care settings or providing
p.001321: primary and specialty care services in community- based mental health and substance use disorder serv- ice
p.001321: settings.
p.001321: (B) The establishment of goals and objectives for the period of the plan, including targets and
p.001321: milestones that are intended to be met, and the activities that will be un- dertaken to achieve those targets.
p.001321: (C) A description of how the State will comply with each funding agreement for a grant under section
p.001321: 1921 that is applicable to the State, including a description of the manner in which the State intends
p.001321: to expend grant funds.
p.001321: (2) MODIFICATIONS.—
p.001321: (A) AUTHORITY OF SECRETARY.—As a condition; 9 of making a grant under section 1921 to a State for a
p.001321: fiscal year, the Secretary may require that the State modify any provision of the plan submitted by the State
p.001321: under sub- section (a)(6) (including provisions on priorities in carrying out authorized activities). If the
p.001321: Secretary approves the plan and makes the grant to the State for the fiscal year, the Secretary may not
p.001321: during such year require the State to modify the plan.
p.001321: (B) STATE REQUEST FOR MODIFICATION.—If the State determines that a modification to such plan is
p.001321: necessary, the State may request the Secretary to approve the modi- fication. Any such modification shall be
p.001321: in accordance with paragraph (1) and section 1941.
p.001321:
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p.001321: 9 The semicolon after ‘‘a condition’’ in paragraph (2)(A) probably should not appear. See amendment made by
p.001321: section 8002(i)(2)(B)(ii) of Public Law 114–255.
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p.001325: section 1921(b).
p.001325: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1921 to a State, means that the
p.001325: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001325: (3) The term ‘‘prevention activities’’, subject to section 1931, means activities to prevent substance
p.001325: use disorders.
p.001325: (4) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.001325:
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p.001325: 11 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘under this subpart’’.
p.001325: 12 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘sub- section’’.
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p.001327: 1327
p.001327: PUBLIC HEALTH SERVICE ACT
p.001327: Sec. 1941
p.001327:
p.001327: (5) The term ‘‘treatment activities’’ means treatment serv- ices and, subject to section 1931, authorized activities
p.001327: that are related to treatment services.
p.001327: (6) The term ‘‘treatment facility’’ means an entity that pro- vides treatment services.
p.001327: (7) The term ‘‘treatment services’’, subject to section 1931, means treatment for substance use disorders.
p.001327: SEC. 1935. ø300x–35¿ FUNDING.
p.001327: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, subpart III and
p.001327: section 505(d) with re- spect to substance abuse, and section 515(d), there are authorized to be
p.001327: appropriated $1,858,079,000 for each of fiscal years 2018 through 2022.. 13
p.001327: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, NATIONAL DATA BASE, DATA COLLECTION, AND PROGRAM EVALUATIONS.—
p.001327: (1) IN GENERAL.—
p.001327: (A) For the purpose of carrying out section 1948(a) with respect to substance abuse, section 515(d), and
p.001327: the purposes specified in subparagraphs (B) and (C), the Sec- retary shall obligate 5 percent of
p.001327: the amounts appro- priated under subsection (a) each fiscal year.
p.001327: (B) The purpose specified in this subparagraph is the collection of data in this paragraph 14 is
p.001327: carrying out sec- tions 505(d) and 1971 with respect to substance abuse.
p.001327: (C) The purpose specified in this subparagraph is the conduct of evaluations of authorized activities to
p.001327: determine methods for improving the availability and quality of such activities.
p.001327: (2) ACTIVITIES OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—Of the amounts reserved under paragraph (1) for a
...

p.001575: health plan or a health insurance issuer offering group or individual health insur- ance coverage from
p.001575: negotiating the level and type of reimburse- ment with a provider for care provided in accordance with this sec-
p.001575: tion.
p.001575: (f) PREEMPTION; EXCEPTION FOR HEALTH INSURANCE COVERAGE IN CERTAIN STATES.—
p.001575: (1) IN GENERAL.—The requirements of this section shall not apply with respect to health insurance coverage if
p.001575: there is a State law (as defined in section 2723(d)(1)) for a State that regulates such coverage that is
p.001575: described in any of the fol- lowing subparagraphs:
p.001575: (A) Such State law requires such coverage to provide for at least a 48-hour hospital length of stay
p.001575: following a normal vaginal delivery and at least a 96-hour hospital length of stay following a cesarean
p.001575: section.
p.001575: (B) Such State law requires such coverage to provide for maternity and pediatric care in accordance with guide-
p.001575: lines established by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or
p.001575: other established professional medical associations.
p.001575: (C) Such State law requires, in connection with such coverage for maternity care, that the hospital
p.001575: length of stay for such care is left to the decision of (or required to be made by) the attending
p.001575: provider in consultation with the mother.
p.001575: (2) CONSTRUCTION.—Section 2723(a)(1) shall not be con- strued as superseding a State law described in
p.001575: paragraph (1).
p.001575: SEC. 2726. ø300gg–26¿ PARITY IN MENTAL HEALTH AND SUBSTANCE USE DISORDER BENEFITS.
p.001575: (a) IN GENERAL.—
p.001575: (1) AGGREGATE LIFETIME LIMITS.—In the case of a group health plan or a health insurance issuer offering group
p.001575: or indi- vidual health insurance coverage that provides both medical and surgical benefits and mental
p.001575: health or substance use dis- order benefits—
p.001575: (A) NO LIFETIME LIMIT.—If the plan or coverage does not include an aggregate lifetime limit on substantially
p.001575: all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on
p.001575: mental health or substance use disorder benefits.
p.001575: (B) LIFETIME LIMIT.—If the plan or coverage includes an aggregate lifetime limit on substantially all
p.001575: medical and surgical benefits (in this paragraph referred to as the ‘‘applicable lifetime limit’’), the plan or
p.001575: coverage shall ei- ther—
p.001575:
p.001575:
p.001575:
p.001575:
p.001575: January 30, 2020
p.001575: (i) apply the applicable lifetime limit both to the medical and surgical benefits to which it otherwise
p.001575: would apply and to mental health and substance use
p.001575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001575:
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p.001575: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1576
p.001575:
p.001575: disorder benefits and not distinguish in the applica- tion of such limit between such medical and
p.001575: surgical benefits and mental health and substance use disorder benefits; or
p.001575: (ii) not include any aggregate lifetime limit on mental health or substance use disorder benefits that is
p.001575: less than the applicable lifetime limit.
p.001575: (C) RULE IN CASE OF DIFFERENT LIMITS.—In the case of a plan or coverage that is not described in subparagraph
p.001575: (A) or (B) and that includes no or different aggregate life- time limits on different categories of medical and
p.001575: surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or
p.001575: coverage with respect to mental health and substance use disorder bene- fits by substituting for the applicable
p.001575: lifetime limit an av- erage aggregate lifetime limit that
p.001575: is computed taking into account the weighted average of the aggregate lifetime limits applicable to such
p.001575: categories.
p.001575: (2) ANNUAL LIMITS.—In the case of a group health plan or a health insurance issuer offering group or
p.001575: individual health insurance coverage that provides both medical and surgical benefits and mental health or
p.001575: substance use disorder bene- fits—
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p.001575: January 30, 2020
p.001575: (A) NO ANNUAL LIMIT.—If the plan or coverage does not include an annual limit on substantially all
p.001575: medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health or
p.001575: substance use dis- order benefits.
p.001575: (B) ANNUAL LIMIT.—If the plan or coverage includes an annual limit on substantially all medical and
p.001575: surgical benefits (in this paragraph referred to as the ‘‘applicable annual limit’’), the plan or coverage
p.001575: shall either—
p.001575: (i) apply the applicable annual limit both to med- ical and surgical benefits to which it otherwise would apply
p.001575: and to mental health and substance use disorder benefits and not distinguish in the application of such limit between
p.001575: such medical and surgical benefits and mental health and substance use disorder benefits; or
p.001575: (ii) not include any annual limit on mental health or substance use disorder benefits that is less than the applicable
p.001575: annual limit.
p.001575: (C) RULE IN CASE OF DIFFERENT LIMITS.—In the case of a plan or coverage that is not described in subparagraph
p.001575: (A) or (B) and that includes no or different annual limits on different categories of medical and surgical
p.001575: benefits, the Secretary shall establish rules under which subparagraph
p.001575: (B) is applied to such plan or coverage with respect to mental health and substance use disorder benefits by
p.001575: sub- stituting for the applicable annual limit an average annual limit that is computed taking into account the
p.001575: weighted average of the annual limits applicable to such categories.
p.001575: (3) FINANCIAL REQUIREMENTS AND TREATMENT LIMITA- TIONS.—
p.001575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001575:
p.001577: 1577
p.001577: PUBLIC HEALTH SERVICE ACT
p.001577: Sec. 2726
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p.001577: January 30, 2020
p.001577: (A) IN GENERAL.—In the case of a group health plan or a health insurance issuer offering group or
p.001577: individual health insurance coverage that provides both medical and surgical benefits and mental health or
p.001577: substance use dis- order benefits, such plan or coverage shall ensure that—
p.001577: (i) the financial requirements applicable to such mental health or substance use disorder benefits are no
p.001577: more restrictive than the predominant financial re- quirements applied to substantially all medical and surgical
p.001577: benefits covered by the plan (or coverage), and there are no separate cost sharing requirements that are
p.001577: applicable only with respect to mental health or substance use disorder benefits; and
p.001577: (ii) the treatment limitations applicable to such mental health or substance use disorder benefits are no
p.001577: more restrictive than the predominant treatment limitations applied to substantially all medical and
p.001577: surgical benefits covered by the plan (or coverage) and there are no separate treatment limitations that are
p.001577: applicable only with respect to mental health or sub- stance use disorder benefits.
p.001577: (B) DEFINITIONS.—In this paragraph:
p.001577: (i) FINANCIAL REQUIREMENT.—The term ‘‘financial requirement’’ includes deductibles, copayments, coin- surance,
p.001577: and out-of-pocket expenses, but excludes an aggregate lifetime limit and an annual limit subject to paragraphs (1)
p.001577: and (2).
p.001577: (ii) PREDOMINANT.—A financial requirement or treatment limit is considered to be predominant if it is
p.001577: the most common or frequent of such type of limit or requirement.
p.001577: (iii) TREATMENT LIMITATION.—The term ‘‘treat- ment limitation’’ includes limits on the frequency of
p.001577: treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment.
p.001577: (4) AVAILABILITY OF PLAN INFORMATION.—The criteria for medical necessity determinations made under the plan with
p.001577: re- spect to mental health or substance use disorder benefits (or the health insurance coverage offered
p.001577: in connection with the plan with respect to such benefits) shall be made available by the plan
p.001577: administrator (or the health insurance issuer offering such coverage) in accordance with regulations to any current or
p.001577: potential participant, beneficiary, or contracting provider upon request. The reason for any denial under the plan (or
p.001577: coverage) of reimbursement or payment for services with respect to men- tal health or substance use disorder benefits
p.001577: in the case of any participant or beneficiary shall, on request or as otherwise re- quired, be made available by
p.001577: the plan administrator (or the health insurance issuer offering such coverage) to the partici- pant or
p.001577: beneficiary in accordance with regulations.
p.001577: (5) OUT-OF-NETWORK PROVIDERS.—In the case of a plan or coverage that provides both medical and surgical
p.001577: benefits and mental health or substance use disorder benefits, if the plan or coverage provides coverage for medical
p.001577: or surgical benefits pro-
p.001577: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001577:
p.001577:
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p.001577:
p.001577: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1578
p.001577:
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p.001577: January 30, 2020
p.001577:
p.001577: vided by out-of-network providers, the plan or coverage shall provide coverage for mental health or
p.001577: substance use disorder benefits provided by out-of-network providers in a manner that is consistent with the
p.001577: requirements of this section.
p.001577: (6) COMPLIANCE PROGRAM GUIDANCE DOCUMENT.—
p.001577: (A) IN GENERAL.—Not later than 12 months after the date of enactment of the Helping Families in
p.001577: Mental Health Crisis Reform Act of 2016, the Secretary, the Sec- retary of Labor, and the Secretary of the
...

p.001579: information and illustrative examples of methods that group health plans and health insurance issuers offering
p.001579: group or individual health insurance coverage may use for disclosing information to ensure compli- ance with the
p.001579: requirements under this section, section 712 of the Employee Retirement Income Security Act of 1974, or section
p.001579: 9812 of the Internal Revenue Code of 1986, as applicable, (and any regulations promul- gated pursuant to such
p.001579: sections, as applicable).
p.001579: (ii) DOCUMENTS FOR PARTICIPANTS, BENEFICIARIES, CONTRACTING PROVIDERS, OR AUTHORIZED REPRESENTA- TIVES.—The
p.001579: guidance issued under this paragraph shall include clarifying information and illustrative ex- amples of
p.001579: methods that group health plans and health insurance issuers offering group or individual health insurance
p.001579: coverage may use to provide any partici- pant, beneficiary, contracting provider, or authorized
p.001579: representative, as applicable, with documents con- taining information that the health plans or
p.001579: issuers are required to disclose to participants, beneficiaries, contracting providers, or authorized
p.001579: representatives to ensure compliance with this section, section 712 of the Employee Retirement Income Security Act
p.001579: of 1974, or section 9812 of the Internal Revenue Code of 1986, as applicable, compliance with any regulation issued
p.001579: pur- suant to such respective section, or compliance with any other applicable law or regulation. Such guidance
p.001579: shall include information that is comparative in na- ture with respect to—
p.001579: (I) nonquantitative treatment limitations for both medical and surgical benefits and mental health and
p.001579: substance use disorder benefits;
p.001579: (II) the processes, strategies, evidentiary standards, and other factors used to apply the
p.001579: limitations described in subclause (I); and
p.001579: (III) the application of the limitations de- scribed in subclause (I) to ensure that such limita- tions
p.001579: are applied in parity with respect to both medical and surgical benefits and mental health and substance
p.001579: use disorder benefits.
p.001579: (C) NONQUANTITATIVE TREATMENT LIMITATIONS.—The guidance issued under this paragraph shall include clari-
p.001579: fying information and illustrative examples of methods, processes, strategies, evidentiary standards, and other
p.001579: fac- tors that group health plans and health insurance issuers offering group or individual health insurance
p.001579: coverage may use regarding the development and application of non-
p.001579: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001579:
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p.001581: 1581
p.001581: PUBLIC HEALTH SERVICE ACT
p.001581: Sec. 2726
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p.001581: January 30, 2020
p.001581: quantitative treatment limitations to ensure compliance with this section, section 712 of the Employee
p.001581: Retirement Income Security Act of 1974, or section 9812 of the Inter- nal Revenue Code of 1986, as
p.001581: applicable, (and any regula- tions promulgated pursuant to such respective section), in- cluding—
p.001581: (i) examples of methods of determining appro- priate types of nonquantitative treatment limitations
p.001581: with respect to both medical and surgical benefits and mental health and substance use disorder benefits, in- cluding
p.001581: nonquantitative treatment limitations per- taining to—
p.001581: (I) medical management standards based on medical necessity or appropriateness, or whether a treatment is
p.001581: experimental or investigative;
p.001581: (II) limitations with respect to prescription drug formulary design; and
p.001581: (III) use of fail-first or step therapy protocols;
p.001581: (ii) examples of methods of determining—
p.001581: (I) network admission standards (such as credentialing); and
p.001581: (II) factors used in provider reimbursement methodologies (such as service type, geographic market, demand
p.001581: for services, and provider supply, practice size, training, experience, and licensure) as such factors apply to
p.001581: network adequacy;
p.001581: (iii) examples of sources of information that may serve as evidentiary standards for the purposes of
p.001581: making determinations regarding the development and application of nonquantitative treatment limita-
p.001581: tions;
p.001581: (iv) examples of specific factors, and the evi- dentiary standards used to evaluate such factors, used by
p.001581: such plans or issuers in performing a nonquantita- tive treatment limitation analysis;
p.001581: (v) examples of how specific evidentiary standards may be used to determine whether treatments are con- sidered
p.001581: experimental or investigative;
p.001581: (vi) examples of how specific evidentiary stand- ards may be applied to each service category or classi- fication
p.001581: of benefits;
p.001581: (vii) examples of methods of reaching appropriate coverage determinations for new mental health or sub- stance
...

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p.001581:
p.001581: Sec. 2726 PUBLIC HEALTH SERVICE ACT 1582
p.001581:
p.001581: (ix) additional illustrative examples of methods, processes, strategies, evidentiary standards, and other factors
p.001581: for which the Secretary determines that addi- tional guidance is necessary to improve compliance with this
p.001581: section, section 712 of the Employee Retire- ment Income Security Act of 1974, or section 9812 of the
p.001581: Internal Revenue Code of 1986, as applicable.
p.001581: (D) PUBLIC COMMENT.—Prior to issuing any final guid- ance under this paragraph, the Secretary shall provide a
p.001581: public comment period of not less than 60 days during which any member of the public may provide comments on a
p.001581: draft of the guidance.
p.001581: (b) CONSTRUCTION.—Nothing in this section shall be construed—
p.001581: (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage to provide any mental health or substance use disorder benefits; or
p.001581:
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p.001581: January 30, 2020
p.001581: (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions
p.001581: of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a).
p.001581: (c) EXEMPTIONS.—
p.001581: (1) SMALL EMPLOYER EXEMPTION.—This section shall not apply to any group health plan and a health
p.001581: insurance issuer offering group or individual health insurance coverage for any plan year of a small employer
p.001581: (as defined in section 2791(e)(4), except that for purposes of this paragraph such term shall in- clude employers with
p.001581: 1 employee in the case of an employer re- siding in a State that permits small groups to include a single individual).
p.001581: (2) COST EXEMPTION.—
p.001581: (A) IN GENERAL.—With respect to a group health plan or a health insurance issuer offering group or individual
p.001581: health insurance coverage, if the application of this section to such plan (or coverage) results in an increase
p.001581: for the plan year involved of the actual total costs of coverage with respect to medical and surgical
p.001581: benefits and mental health and substance use disorder benefits under the plan (as determined and certified under
p.001581: subparagraph (C)) by an amount that exceeds the applicable percentage de- scribed in subparagraph
p.001581: (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or
p.001581: coverage) during the following plan year, and such ex- emption shall apply to the plan (or coverage)
p.001581: for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder
p.001581: parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any
p.001581: increase in total costs.
p.001581: (B) APPLICABLE PERCENTAGE.—With respect to a plan (or coverage), the applicable percentage described
p.001581: in this subparagraph shall be—
p.001581: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001581:
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p.001583: PUBLIC HEALTH SERVICE ACT
p.001583: Sec. 2726
p.001583:
p.001583: (i) 2 percent in the case of the first plan year in which this section is applied; and
p.001583: (ii) 1 percent in the case of each subsequent plan year.
p.001583: (C) DETERMINATIONS BY ACTUARIES.—Determinations as to increases in actual costs under a plan (or
p.001583: coverage) for purposes of this section shall be made and certified by a qualified and licensed actuary who is a member
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p.001583: of such exemption under subparagraph (E). A State agency receiv- ing a notification under subparagraph (E) may
p.001583: also con- duct such an audit with respect to an exemption covered by such notification.
p.001583: (d) SEPARATE APPLICATION TO EACH OPTION OFFERED.—In the case of a group health plan that offers a participant or
p.001583: beneficiary two or more benefit package options under the plan, the require- ments of this section shall
p.001583: be applied separately with respect to each such option.
p.001583: (e) DEFINITIONS.—For purposes of this section—
p.001583: (1) AGGREGATE LIFETIME LIMIT.—The term ‘‘aggregate life- time limit’’ means, with respect to benefits under
p.001583: a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with
p.001583: respect to such bene- fits under the plan or health insurance coverage with respect to an individual or
p.001583: other coverage unit.
p.001583: (2) ANNUAL LIMIT.—The term ‘‘annual limit’’ means, with respect to benefits under a group health
p.001583: plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid
p.001583: with respect to such benefits in a 12- month period under the plan or health insurance coverage with respect to an
p.001583: individual or other coverage unit.
p.001583: (3) MEDICAL OR SURGICAL BENEFITS.—The term ‘‘medical or surgical benefits’’ means benefits with
p.001583: respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may
p.001583: be), but does not include mental health or substance use disorder benefits.
p.001583: (4) MENTAL HEALTH BENEFITS.—The term ‘‘mental health benefits’’ means benefits with respect to services
p.001583: for mental health conditions, as defined under the terms of the plan and in accordance with applicable
p.001583: Federal and State law.
p.001583: (5) SUBSTANCE USE DISORDER BENEFITS.—The term ‘‘sub- stance use disorder benefits’’ means benefits with
p.001583: respect to services for substance use disorders, as defined under the terms of the plan and in
p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
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p.000377: Sec. 340G PUBLIC HEALTH SERVICE ACT 378
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p.000377: January 30, 2020
p.000377:
p.000377: (A) the expansion or establishment of a community- based dental facility, free-standing dental clinic,
p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
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p.000735: research, train- ing, health information dissemination, and other programs with re- spect to the cause, prevention, and
p.000735: methods of diagnosis and treat- ment of dental and oral diseases and conditions.
p.000735:
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p.000735: January 30, 2020
p.000735:
p.000735: 35 So in law. Probably should be ‘‘SEC. 452F.’’. See amendments made by sections 201 and 1002 of Public
p.000735: Law 106–310 (114 Stat. 1109, 1128). (In amending this subpart to add section 452G above, such section
p.000735: 1002 made a reference to this subpart ‘‘as amended by section 921’’ of Public Law 106–310, but no section
p.000735: 921 appeared in the Public Law.)
p.000735: 36 See footnote for section 401(b)(1)(H).
p.000735: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000737: 737
p.000737: PUBLIC HEALTH SERVICE ACT
p.000737:
p.000737: Subpart 9—National Eye Institute
p.000737: Sec. 456
p.000737:
p.000737: PURPOSE OF THE INSTITUTE
p.000737:
p.000737: SEC. 455. ø285i¿ The general purpose of the National Eye In- stitute (hereafter in this subpart referred
p.000737: to as the ‘‘Institute’’) is the conduct and support of research, training, health information
p.000737: dissemination, and other programs with respect to blinding eye dis- eases, visual disorders, mechanisms of visual
p.000737: function, preservation of sight, and the special health problems and requirements of the blind. Subject to
p.000737: section 456, the Director of the Institute may carry out a program of grants for public and private
p.000737: nonprofit vi- sion research facilities.
p.000737:
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p.000737: January 30, 2020
p.000737: CLINICAL RESEARCH ON EYE CARE AND DIABETES
p.000737: SEC. 456. ø285i–1¿ (a) PROGRAM OF GRANTS.—The Director of
p.000737: the Institute, in consultation with the advisory council for the In- stitute, may award research grants
p.000737: to one or more Diabetes Eye Research Institutions for the support of programs in clinical or health
p.000737: services aimed at—
p.000737: (1) providing comprehensive eye care services for people with diabetes, including a full complement of
p.000737: preventive, diag- nostic and treatment procedures;
p.000737: (2) developing new and improved techniques of patient care through basic and clinical research;
p.000737: (3) assisting in translation of the latest research advances into clinical practice; and
p.000737: (4) expanding the knowledge of the eye and diabetes through further research.
p.000737: (b) USE OF FUNDS.—Amounts received under a grant awarded under this section shall be used for the following:
p.000737: (1) Establishing the biochemical, cellular, and genetic mechanisms associated with diabetic eye
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p.000001:
p.000001: Sec. 203A PUBLIC HEALTH SERVICE ACT 4
p.000001:
p.000001: active duty shall be deemed to be commissioned officers of the Reg- ular Corps.
p.000001: (c) PURPOSE AND USE OF READY RESEARCH.—
p.000001: (1) PURPOSE.—The purpose of the Ready Reserve Corps is to fulfill the need to have additional Commissioned
p.000001: Corps per- sonnel available on short notice (similar to the uniformed serv- ice’s reserve program) to assist
p.000001: regular Commissioned Corps personnel to meet both routine public health and emergency response missions.
p.000001: (2) USES.—The Ready Reserve Corps shall—
p.000001: (A) participate in routine training to meet the general and specific needs of the Commissioned Corps;
p.000001: (B) be available and ready for involuntary calls to ac- tive duty during national emergencies and public
p.000001: health crises, similar to the uniformed service reserve personnel;
p.000001: (C) be available for backfilling critical positions left va- cant during deployment of active duty
p.000001: Commissioned Corps members, as well as for deployment to respond to public health emergencies, both foreign
p.000001: and domestic; and
p.000001: (D) be available for service assignment in isolated, hardship, and medically underserved communities (as
p.000001: de- fined in section 799B) to improve access to health services.
p.000001: (d) FUNDING.—For the purpose of carrying out the duties and responsibilities of the Commissioned Corps
p.000001: under this section, there are authorized to be appropriated $5,000,000 for each of fis- cal years
p.000001: 2010 through 2014 for recruitment and training and
p.000001: $12,500,000 for each of fiscal years 2010 through 2014 for the Ready Reserve Corps.
p.000001: SEC. 203A. ø204a¿ DEPLOYMENT READINESS.
p.000001: (a) READINESS REQUIREMENTS FOR COMMISSIONED CORPS OFFI-
p.000001: CERS.—
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p.000001: January 30, 2020
p.000001: (1) IN GENERAL.—The Secretary, with respect to members of the following Corps components, shall establish
p.000001: require- ments, including training and medical examinations, to ensure the readiness of such components to
p.000001: respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State,
p.000001: and local levels:
p.000001: (A) Active duty Regular Corps.
p.000001: (B) Active Reserves.
p.000001: (2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary shall annually determine whether each member of the
p.000001: Corps meets the applicable readiness requirements established under paragraph (1).
p.000001: (3) FAILURE TO MEET REQUIREMENTS.—A member of the Corps who fails to meet or maintain the readiness
p.000001: require- ments established under paragraph (1) or who fails to comply with orders to respond to an urgent or
...

p.000001: appointed to fill a vacancy occurring prior to the expiration of the term for which his prede- cessor was
p.000001: appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after
p.000001: the date of enactment of this subsection shall expire as follows: four shall expire four years after such
p.000001: date, four shall expire three years after such date, four shall expire two years after such date, and three
p.000001: shall expire one year after such date, as designated by the Secretary at the time of appointment.
p.000001: (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
p.000001: TRAINING OF OFFICERS
p.000001: SEC. 218. ø218a¿ (a) Appropriations available for the pay and allowances of commissioned officers of the
p.000001: Service shall also be available for the pay and allowances of any such officer on active
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 8 As a result of the amendments made by Public Law 104–299 (110 Stat. 3626), the Public Health Service
p.000001: Act no longer contained a section 329, 340, or 340A, and section 330 of such Act was substantially revised. Section
p.000001: 330 now includes provisions that relate to medically under- served populations, to migratory and seasonal
p.000001: agricultural workers, to homeless individuals, and to residents of public housing. Section 402 of Public Law 107–251
p.000001: (116 Stat. 1655) added a new section 340 that relates to a healthy communities access program.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 23 PUBLIC HEALTH SERVICE ACT Sec. 219
p.000001:
p.000001: duty while attending any Federal or non-Federal educational insti- tution or training program and, subject to
p.000001: regulations of the Presi- dent and to the limitation prescribed in such appropriations, for payment of his
p.000001: tuition, fees, and other necessary expenses incident to such attendance.
p.000001: (b) Any officer whose tuition, fees, and other necessary ex- penses are paid pursuant to subsection (a) while
p.000001: attending an edu- cational institution or training program for a period in excess of thirty days shall be
p.000001: obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other
p.000001: necessary expenses received by such officer during such period, and two times the total amount of any
p.000001: compensation received by, and any allowance paid to, such officer during such period, if after re- turn
p.000001: to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the
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p.000001: on or after January 1, 1993.
p.000001: (4) An entity described in this paragraph is a public or non- profit private entity receiving Federal funds
p.000001: under section 330.
p.000001: (5) For purposes of paragraph (1), an individual may be consid- ered a contractor of an entity described in
p.000001: paragraph (4) only if—
p.000001: (A) the individual normally performs on average at least 321⁄2 hours of service per week for the entity
p.000001: for the period of the contract; or
p.000001: (B) in the case of an individual who normally performs an average of less than 321⁄2 hours of services per week for the
p.000001: en- tity for the period of the contract, the individual is a licensed or certified provider of services in
p.000001: the fields of family practice, general internal medicine, general pediatrics, or obstetrics and gynecology.
p.000001: (h) The Secretary may not approve an application under sub- section (g)(1)(D) unless the Secretary
p.000001: determines that the entity—
p.000001: (1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits
p.000001: arising out of any health or health-related functions performed by the entity;
p.000001: (2) has reviewed and verified the professional credentials, references, claims history, fitness,
p.000001: professional review organi- zation findings, and license status of its physicians and other licensed or
p.000001: certified health care practitioners, and, where nec- essary, has obtained the permission from these
p.000001: individuals to gain access to this information;
p.000001: (3) has no history of claims having been filed against the United States as a result of the
p.000001: application of this section to the entity or its officers, employees, or contractors as provided for under this
p.000001: section, or, if such a history exists, has fully co- operated with the Attorney General in defending against
p.000001: any such claims and either has taken, or will take, any necessary corrective steps to assure against
p.000001: such claims in the future; and
p.000001: (4) will fully cooperate with the Attorney General in pro-
p.000001: viding information relating to an estimate described under sub- section (k).
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 10 So in law. See section 5(a) of Public Law 104–73 (109 Stat. 779). There is no closing paren- thesis.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 30
p.000001: (i)(1) Notwithstanding subsection (g)(1), the Attorney General, in consultation with the Secretary, may on
p.000001: the record determine, after notice and opportunity for a full and fair hearing, that an in- dividual physician or
p.000001: other licensed or certified health care practi- tioner who is an officer, employee, or contractor of an
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p.000001: each of the agencies and offices of the Department of Health and Human Services;
p.000001: (5) establish a National Women’s Health Information Cen- ter to—
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 16 Section 3509 of the Patient Protection and Affordable Care Act (Public Law 111–148, en- acted March 23,
p.000001: 2010) established offices of womens health in the Office of the Secretary of HHS (this section), the Centers for
p.000001: Disease Control and Prevention (section 310A of this Act), the Agency for Healthcare Research and Quality
p.000001: (section 925 of this Act), the Health Resources and Services Administration (section 713 of the Social Security Act),
p.000001: and the Food and Drug Admin- istration (section 1011 of the Federal Food, Drug, and Cosmetic Act).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 49 PUBLIC HEALTH SERVICE ACT Sec. 231
p.000001:
p.000001: (A) facilitate the exchange of information regarding matters relating to health information, health
p.000001: promotion, preventive health services, research advances, and edu- cation in the appropriate use of health care;
p.000001: (B) facilitate access to such information;
p.000001: (C) assist in the analysis of issues and problems relat- ing to the matters described in this paragraph; and
p.000001: (D) provide technical assistance with respect to the ex- change of information (including facilitating the
p.000001: develop- ment of materials for such technical assistance);
p.000001: (6) coordinate efforts to promote women’s health programs and policies with the private sector; and
p.000001: (7) through publications and any other means appropriate, provide for the exchange of information between the Office
p.000001: and recipients of grants, contracts, and agreements under sub- section (c), and between the Office and
p.000001: health professionals and the general public.
p.000001: (c) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.000001: (1) AUTHORITY.—In carrying out subsection (b), the Sec- retary may make grants to, and enter into
p.000001: cooperative agree- ments, contracts, and interagency agreements with, public and private entities, agencies, and
p.000001: organizations.
p.000001: (2) EVALUATION AND DISSEMINATION.—The Secretary shall directly or through contracts with public and private
p.000001: entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance
p.000001: provided under paragraph
p.000001: (1) and for the dissemination of information developed as a re- sult of such projects.
p.000001: (d) REPORTS.—Not later than 1 year after the date of enact- ment of this section, and every second
p.000001: year thereafter, the Sec- retary shall prepare and submit to the appropriate committees of Congress a
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p.000017: vide the name of such individual or any such information, docu- ment, or biospecimen that contains
p.000017: identifiable, sensitive informa- tion about the individual and that was created or compiled for pur- poses of the
p.000017: research, except in the circumstance described in sub- paragraph (C)(iii).
p.000017: (E) Identifiable, sensitive information protected under subpara- graph (A), and all copies thereof, shall be
p.000017: immune from the legal process, and shall not, without the consent of the individual to whom the
p.000017: information pertains, be admissible as evidence or used for any purpose in any action, suit, or other judicial,
p.000017: legislative, or administrative proceeding.
p.000017: (F) Identifiable, sensitive information collected by a person to whom a certificate has been issued under
p.000017: subparagraph (A), and all copies thereof, shall be subject to the protections afforded by this section for
p.000017: perpetuity.
p.000017: (G) The Secretary shall take steps to minimize the burden to researchers, streamline the process, and
p.000017: reduce the time it takes to comply with the requirements of this subsection.
p.000017: (2) The Secretary shall coordinate with the heads of other ap- plicable Federal agencies to ensure that
p.000017: such departments have policies in place with respect to the issuance of a certificate of con- fidentiality pursuant
p.000017: to paragraph (1) and other requirements of this subsection.
p.000017: (3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of
p.000017: research to information about himself or herself collected during such individual’s partici- pation in the
p.000017: research.
p.000017: (4) For purposes of this subsection, the term ‘‘identifiable, sen- sitive information’’ means information that is
p.000017: about an individual and that is gathered or used during the course of research de- scribed in paragraph
p.000017: (1)(A) and—
p.000017: (A) through which an individual is identified; or
p.000017: (B) for which there is at least a very small risk, as deter- mined by current scientific practices or
p.000017: statistical methods, that some combination of the information, a request for the in- formation, and other available
p.000017: data sources could be used to deduce the identity of an individual.
p.000017: (e) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.000017: expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Pre- vention with
p.000017: respect to preterm labor and delivery and infant mor- tality.
p.000017: (f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical
p.000017: information that is about an individual and that is gathered or used during the course of biomedical
p.000017: research if—
p.000017: (A) an individual is identified; or
p.000017: (B) there is at least a very small risk, as determined by current scientific practices or statistical
p.000017: methods, that some combination of the information, the request, and other avail- able data sources could be
p.000017: used to deduce the identity of an in- dividual.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 77 PUBLIC HEALTH SERVICE ACT Sec. 302
p.000017:
p.000017: (2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in
p.000017: writing and accompanied by a statement of the basis for the determination.
p.000017: (B) Each such determination and statement of basis shall be available to the public, upon request,
p.000017: through the Office of the Chief FOIA Officer of the Department of Health and Human Serv- ices.
p.000017: (3) Nothing in this subsection shall be construed to limit a re- search participant’s access to information about
p.000017: such participant collected during the participant’s participation in the research.
p.000017: (g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of
p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
p.000017:
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p.000017: January 30, 2020
p.000017: NARCOTICS
p.000017: SEC. 302. ø242¿ (a) In carrying out the purposes of section 301 with respect to drugs the use or misuse of
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p.000017: (e) For the purpose of producing comparable and uniform health information and statistics, there is
p.000017: established the Coopera- tive Health Statistics System. The Secretary, acting through the Center, shall—
p.000017: (1) coordinate the activities of Federal agencies involved in the design and implementation of the System;
p.000017: (2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting
p.000017: the System;
p.000017: (3) make grants to and enter into contracts with State and local health agencies to assist them in meeting the
p.000017: costs of data collection and other activities carried out under the Sys- tem; and
p.000017: (4) review the statistical activities of the Department of Health and Human Services to assure that they are
p.000017: consistent with the System.
p.000017: States participating in the System shall designate a State agency to administer or be responsible for the
p.000017: administration of the statis- tical activities within the State under the System. The Secretary, acting
p.000017: through the Center, shall prescribe guidelines to assure that
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 81 PUBLIC HEALTH SERVICE ACT Sec. 306
p.000017:
p.000017: statistical activities within States participating in the system 4 produce uniform and timely data and assure
p.000017: appropriate access to such data.
p.000017: (f) To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate
p.000017: and consult with the Depart- ments of Commerce and Labor and any other interested Federal departments or
p.000017: agencies and with State and local health depart- ments and agencies. For such purpose he shall utilize
p.000017: insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to
p.000017: section 3709 of the Revised Stat- utes (41 U.S.C. 5), of any appropriate State or other public agency, and may,
p.000017: without regard to such section, utilize the services or fa- cilities of any private agency, organization, group, or
p.000017: individual, in accordance with written agreements between the head of such agency, organization, or group
p.000017: and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities
p.000017: shall be made in such amounts as may be provided in such agreement.
p.000017: (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health
p.000017: data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation
p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
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p.000017: Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private
p.000017: entities reasonable fees for the training of their personnel under the preceding sentence.
p.000017: (c)(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a
p.000017: plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies
p.000017: under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or con- dition
p.000017: and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the
p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
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p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
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p.000017: January 30, 2020
p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
p.000017: (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the
p.000017: manufac- turers of the devices;
p.000017: (4) by providing training to members of the public in cardiopulmonary resuscitation and automated
p.000017: external defibrillation;
p.000017: (5) by integrating the emergency medical services system with the public access defibrillation programs so
p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
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p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
p.000017: (7) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (d) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a State, political subdivision
p.000017: of a State, Indian tribe, or tribal organization shall prepare and submit an appli- cation to the Secretary at such
p.000017: time, in such manner, and con- taining such information as the Secretary may reasonably re- quire.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) shall—
p.000017: (A) describe the comprehensive public access defibrillation program to be funded with the
p.000017: grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to
p.000017: cardiac ar- rest victims in the community;
p.000017: (B) contain procedures for implementing appropriate nationally recognized training courses in
p.000017: performing cardiopulmonary resuscitation and the use of automated external defibrillators;
p.000017: (C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with
p.000017: the local emergency medical services system in the over- sight of training and notification of incidents of the
p.000017: use of the automated external defibrillators;
p.000017: (D) contain procedures for proper maintenance and testing of the automated external defibrillators,
p.000017: according to the labeling of the manufacturer;
p.000017: (E) contain procedures for ensuring notification of local emergency medical services system personnel, including
p.000017: dispatchers, of the location and type of devices used in the public access defibrillation program; and
p.000017: (F) provide for the collection of data regarding the ef- fectiveness of the public access defibrillation
p.000017: program to be funded with the grant in affecting the out-of-hospital car- diac arrest survival rate.
p.000017: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated
p.000017: $25,000,000 for for 6 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts
p.000017: received under a grant awarded under this section may be used for administrative expenses.
p.000017: SEC. 313. ø245¿ PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal
p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
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p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
p.000017: providing pub- lic access to automated external defibrillation; and
p.000017: (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded
p.000017: with the grant in—
p.000017: (i) providing emergency cardiopulmonary resus- citation and automated external defibrillation to car- diac
p.000017: arrest victims in the setting served by the dem- onstration project; and
p.000017: (ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000017: $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received
p.000017: under a grant awarded under this section may be used for administrative expenses.
p.000017:
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p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
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p.000017: Sec. 314 PUBLIC HEALTH SERVICE ACT 94
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p.000017: 95 PUBLIC HEALTH SERVICE ACT Sec. 314
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p.000017: tions, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and
p.000017: rehabilitation;
p.000017: (E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this
p.000017: subsection will be used to supplement and, to the extent practicable, to increase the level of funds that
p.000017: would otherwise be made available by the State for the purpose of comprehensive health planning and not to
p.000017: supplant such non-Federal funds;
p.000017: (F) 7 provide such methods of administration (including methods relating to the establishment and maintenance
p.000017: of per- sonnel standards on a merit basis, except that the Secretary shall exercise no authority with respect
p.000017: to the selection, tenure of office, and compensation of any individual employed in ac- cordance with such
p.000017: methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
p.000017: (G) provide that the State agency will make such reports, in such form and containing such information, as the
p.000017: Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as
p.000017: the Secretary finds necessary to assure the correctness and verification of such re- ports;
p.000017: (H) provide that the State agency will from time to time, but not less often than annually, review its
p.000017: State plan ap- proved under this subsection and submit to the Secretary ap- propriate modifications
p.000017: thereof;
p.000017: (I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop
p.000017: a program for cap- ital expenditures for replacement, modernization, and expan- sion which is consistent
p.000017: with an overall State plan developed in accordance with criteria established by the Secretary after
p.000017: consultation with the State which will meet the needs of the State for health care facilities, equipment, and
p.000017: services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State
p.000017: agency furnishing such assistance will periodically review the program (developed pur- suant to clause (i)) of each
p.000017: health care facility in the State and recommended appropriate modification thereof;
p.000017: (J) provide for such fiscal control and fund accounting pro- cedures as may be necessary to assure proper disbursement
p.000017: of and accounting for funds paid to the State under this sub- section; and
p.000017: (K) contain such additional information and assurances as the Secretary may find necessary to carry out the
p.000017: purposes of this subsection.
p.000017: (3)(A) STATE ALLOTMENTS.—From the sums appropriated for such purpose for each fiscal year, the several
p.000017: States shall be enti- tled to allotments determined, in accordance with regulations, on the basis of the
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p.000017: of the services provided by the ap- plicant in such program in such period, (C) the amount of Fed- eral funds
p.000017: needed by the applicant to continue providing such services in such program, and (D) if the applicant
p.000017: proposes changes in the provision of the services in such program, the priorities of such proposed
p.000017: changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such
p.000017: changes;
p.000017: (3) assurances satisfactory to the Secretary that the pro- gram which will be provided with funds under
p.000017: a grant under subsection (a) will be provided in a manner consistent with the State health plan in effect under
p.000017: section 1524(c) and in those cases where the applicant is a State, that such program will be provided,
p.000017: where appropriate, in a manner consistent with any plans in effect under an application approved under
p.000017: sec- tion 315;
p.000017: (4) assurances satisfactory to the Secretary that the appli- cant will provide for such fiscal control and fund
p.000017: accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and
p.000017: accounting for funds received under grants under subsection (a);
p.000017: (5) assurances satisfactory to the Secretary that the appli- cant will provide for periodic evaluation of its program
p.000017: or pro- grams;
p.000017: (6) assurances satisfactory to the Secretary that the appli- cant will make such reports (in such form and containing
p.000017: such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and
p.000017: keep such records and afford such access thereto as the Secretary may find nec- essary to assure the
p.000017: correctness of, and to verify, such reports;
p.000017: (7) assurances satisfactory to the Secretary that the appli- cant will comply with any other conditions imposed by this
p.000017: sec- tion with respect to grants; and
p.000017: (8) such other information as the Secretary may by regula- tion prescribe.
p.000017: (c)(1) The Secretary shall not approve an application submitted under subsection (b) for a grant for a program
p.000017: for which a grant was previously made under subsection (a) unless the Secretary de- termines—
p.000017: (A) the program for which the application was submitted is operating effectively to achieve its stated purpose,
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000101: PUBLIC HEALTH SERVICE ACT
p.000101: Sec. 317
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p.000101: (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed
p.000101: to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or
p.000101: employee.
p.000101: When the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience
p.000101: of and at the re- quest of such grant recipient and for the purpose of carrying out a program with
p.000101: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall
p.000101: be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in
p.000101: detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of
p.000101: the grant and shall be deemed to have been paid to the grant recipient.
p.000101: (f)(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation
p.000101: prescribe, includ- ing records which fully disclose the amount and disposition by such recipient of the proceeds of
p.000101: such grant, the total cost of the under- taking in connection with which such grant was made, and the amount
p.000101: of that portion of the cost of the undertaking supplied by other sources, and such other records as will
p.000101: facilitate an effective audit.
p.000101: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000101: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000101: records of the recipient of grants under sub- section (a) that are pertinent to such grants.
p.000101: (g)(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to
p.000101: a State or to an agency or a political subdivision of a State under provisions of Federal law (other
p.000101: than this section) and which are available for the conduct of
p.000101: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000101: preventive health service programs from being used on connection with programs assisted through grants under
p.000101: subsection (a).
p.000101: (2) Nothing in this section shall be construed to require any State or any agency or political
p.000101: subdivision of a State to have a preventive health service program which would require any person, who objects to
p.000101: any treatment provided under such a program, to be treated or to have any child or ward treated under such
p.000101: program.
p.000101: (h) The Secretary shall include, as part of the report required by section 1705, a report on the
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p.000107: to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or
p.000107: employee;
p.000107: when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience
p.000107: of and at the re- quest of such grant recipient and for the purpose of carrying out a program with
p.000107: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall
p.000107: be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in
p.000107: detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of
p.000107: the grant and shall be deemed to have been paid to the grant recipient.
p.000107: (h) RECORDS.—Each recipient of a grant under subsection (a) shall keep such records as the Secretary
p.000107: shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the
p.000107: proceeds of such grant, the total cost of the under- taking in connection with which such grant was
p.000107: made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such
p.000107: other records as will facilitate an effective audit.
p.000107: (i) AUDIT AND EXAMINATION OF RECORDS.—The Secretary and the Comptroller General of the United States, or any of
p.000107: their duly authorized representatives, shall have access for the purpose of audit and examination to
p.000107: any books, documents, papers, and records of the recipient of a grant under subsection (a), that are
p.000107: pertinent to such grant.
p.000107: (j) ANNUAL REPORT.—
p.000107: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000107: Sec. 317B PUBLIC HEALTH SERVICE ACT 108
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p.000107: January 30, 2020
p.000107:
p.000107: (1) IN GENERAL.—Not later than May 1 of each year, the Secretary shall submit to the Congress a report
p.000107: on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection
p.000107: (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
p.000107: (2) CERTAIN REQUIREMENTS.—Each report under para- graph (1) shall include, in addition to any other
...

p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
p.000127: regardless of the outcome of the pregnancy.
p.000127: (2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian tribes, and tribal organizations that participate in the
p.000127: program described in this subsection shall, through the State maternal mortality review committee, develop a
p.000127: process that—
p.000127: (A) provides for confidential case reporting of preg- nancy-associated and pregnancy-related deaths to the
p.000127: ap- propriate State or tribal health agency, including such re- porting by—
p.000127: (i) health care professionals;
p.000127: (ii) health care facilities;
p.000127: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000127:
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p.000127: Sec. 317K PUBLIC HEALTH SERVICE ACT 128
p.000127:
p.000127: (iii) any individual responsible for completing death records, including medical examiners and med-
p.000127: ical coroners; and
p.000127: (iv) other appropriate individuals or entities; and
p.000127: (B) provides for voluntary and confidential case report- ing of pregnancy-associated deaths and pregnancy-related
...

p.000131: recognized standards are available, in order to facilitate interoperability between such systems and health
p.000131: information technology systems, in- cluding certified health information technology.
p.000131: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000131: to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
p.000131: SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.000131: (a) GRANTS.—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for
p.000131: screening, assessment, and treatment services, including culturally and linguistically ap- propriate services,
p.000131: as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal
p.000131: depression.
p.000131: (b) APPLICATION.—To seek a grant under this section, a State shall submit an application to the
p.000131: Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a
p.000131: minimum, any such application shall include expla- nations of—
p.000131: (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for
p.000131: mater- nal depression in 1 or more communities; and
p.000131: (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for
p.000131: maternal depression.
p.000131: (c) PRIORITY.—In awarding grants under this section, the Sec- retary may give priority to States proposing to
p.000131: improve or enhance access to screening services for maternal depression in primary care settings.
p.000131: (d) USE OF FUNDS.—The activities eligible for funding through a grant under subsection (a)—
p.000131: (1) shall include—
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000131:
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p.000131: Sec. 317M PUBLIC HEALTH SERVICE ACT 132
p.000131:
p.000131: (A) providing appropriate training to health care pro- viders; and
p.000131: (B) providing information to health care providers, in- cluding information on maternal depression screening,
p.000131: treatment, and followup support services, and linkages to community-based resources; and
p.000131: (2) may include—
p.000131: (A) enabling health care providers (including obstetri- cian-gynecologists, pediatricians, psychiatrists,
p.000131: mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric
p.000131: consultation (in- person or remotely) to aid in the treatment of pregnant and parenting women;
p.000131: (B) establishing linkages with and among community- based resources, including mental health resources, pri- mary
p.000131: care resources, and support groups; and
p.000131: (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in
p.000131: section 330I(a)).
...

p.000133: efits of optimally fluoridated water.
p.000133: (c) SCHOOL-BASED DENTAL SEALANT PROGRAM.—
p.000133: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention
p.000133: and in collaboration with the Administrator of the Health Resources and Services Administration, shall
p.000133: award a grant to each of the 50 States and territories and to Indians, Indian tribes, trib- al organizations
p.000133: and urban Indian organizations (as such
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000133:
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p.000133: Sec. 317M PUBLIC HEALTH SERVICE ACT 134
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p.000133: January 30, 2020
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p.000133: terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development
p.000133: of school-based dental sealant programs to improve the access of children to sealants.
p.000133: (2) USE OF FUNDS.—A State shall use amounts received under a grant under paragraph (1) to provide funds to
p.000133: eligible school-based entities or to public elementary or secondary schools to enable such entities
p.000133: or schools to provide children with access to dental care and dental sealant services. Such services
p.000133: shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws.
p.000133: (3) ELIGIBILITY.—To be eligible to receive funds under paragraph (1), an entity shall—
p.000133: (A) prepare and submit to the State an application at such time, in such manner and containing such informa-
p.000133: tion as the State may require; and
p.000133: (B) be a public elementary or secondary school—
p.000133: (i) that is located in an urban area in which and more than 50 percent of the student population is par-
p.000133: ticipating in Federal or State free or reduced meal pro- grams; or
p.000133: (ii) that is located in a rural area and, with re- spect to the school district in which the school
p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
...

p.000145: departments, as appropriate.
p.000145: (b) CONSULTATION.—In carrying out subsection (a)(1), the Sec- retary shall consult with the Tick-Borne
p.000145: Disease Working Group established under section 2062 of the 21st Century Cures Act (42
p.000145: U.S.C. 284s) and other individuals, as appropriate, such as—
p.000145: (1) epidemiologists with experience in vector-borne dis- eases;
p.000145: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000145:
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p.000145: Sec. 317U PUBLIC HEALTH SERVICE ACT 146
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p.000145: January 30, 2020
p.000145:
p.000145: (2) representatives of patient advocacy and research orga- nizations that focus on vector-borne diseases,
p.000145: including such organizations that have demonstrated experience in related re- search, public health, data collection,
p.000145: or patient access to care;
p.000145: (3) health information technology experts or other informa- tion management specialists;
p.000145: (4) clinicians, entomologists, vector management profes- sionals, public health professionals, and others
p.000145: with expertise in vector-borne diseases; and
p.000145: (5) researchers, including researchers with experience con- ducting translational research.
p.000145: (c) CENTERS OF EXCELLENCE.—The Secretary, in coordination with the Director of the Centers for Disease
p.000145: Control and Preven- tion, shall award grants, contracts, or cooperative agreements to in- stitutions of higher
p.000145: education for the establishment or continued support of regional centers of excellence in vector-borne diseases to
p.000145: address vector-borne diseases, including tick-borne diseases, by—
p.000145: (1) facilitating collaboration between academia and public health organizations for public health surveillance,
p.000145: prevention, and response activities related to vector-borne diseases, includ- ing tick-borne diseases;
p.000145: (2) providing training for public health entomologists and other health care professionals, as appropriate, to
p.000145: address vec- tor-borne diseases, including tick-borne diseases;
p.000145: (3) conducting research to develop and validate prevention and control tools and methods, including
p.000145: evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease
p.000145: outbreaks; or
p.000145: (4) preparing for and responding to outbreaks of vector- borne diseases, including tick-borne diseases.
p.000145: (d) ELIGIBILITY.—To be eligible to receive a grant, contract, or cooperative agreement under subsection (c),
...

p.000147: for fiscal year 1995 and subsequent fiscal years shall be available for payment of the costs of medical care,
p.000147: related expenses, and burial expenses here- after incurred by or on behalf of any person who had
p.000147: participated in the study of untreated syphilis initiated in Tuskegee, Alabama, in 1932, in such amounts
p.000147: and subject to such terms and conditions as prescribed by the Secretary of Health and Human Services and for
p.000147: payment, in such amounts and subject to such terms and conditions, of such costs and expenses hereafter incurred by or
p.000147: on behalf of such person’s wife or offspring determined by the Secretary to have suffered injury or disease from
p.000147: syphilis contracted from such person’’.
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000147:
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p.000147: Sec. 318A PUBLIC HEALTH SERVICE ACT 148
p.000147:
p.000147: proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was
p.000147: given or used and the amount of that portion of the cost of the project or undertaking supplied by other
p.000147: sources, and such other records as will facilitate an effective audit.
p.000147: (3) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000147: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000147: records of the recipients of grants under this section that are pertinent to such grants.
p.000147: (4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair
p.000147: market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances,
p.000147: travel expenses, and any other costs in connection with the detail of an officer or employee of the United
p.000147: States to the recipient when the furnishing of such supplies or equipment or the detail of such an
p.000147: officer or employee is for the convenience of and at the request of such recipient and for the pur- pose of
p.000147: carrying out the program with respect to which the grant under this section is made. The amount by
p.000147: which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in
p.000147: furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
p.000147: (5) All information obtained in connection with the examina- tion, care, or treatment of any individual under
p.000147: any program which is being carried out with a grant made under this section shall not, without such individual’s
p.000147: consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a
p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
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p.000159: and information obtained from an individual that is privileged and confidential, as provided for in section
p.000159: 552(b)(4) of title 5, United States Code, and subject to the penalties and exceptions under sections 1832
p.000159: and 1833 of title 18, United States Code, relat- ing to the protection and theft of trade secrets, and subject to pri-
p.000159: vacy protections that are consistent with the regulations promul- gated under section 264(c) of the Health
p.000159: Insurance Portability and Accountability Act of 1996. None of such information provided by a manufacturer,
p.000159: wholesaler, or distributor shall be disclosed with- out its consent to another manufacturer, wholesaler, or
p.000159: distributor, or shall be used in any manner to give a manufacturer, wholesaler, or distributor a proprietary advantage.
p.000159: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000159:
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p.000159: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 160
p.000159:
p.000159: (d) GUIDELINES.—The Secretary, in order to maintain the con- fidentiality of relevant information and ensure that none
p.000159: of the in- formation contained in the systems involved may be used to pro- vide proprietary advantage within
p.000159: the vaccine market, while allow- ing State, local, and tribal health officials access to such informa- tion
p.000159: to maximize the delivery and availability of vaccines to high priority populations, during times of
p.000159: influenza pandemics, vaccine shortages, and supply disruptions, in consultation with manufac- turers,
p.000159: distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a)
p.000159: and (b).
p.000159: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000159: $30,800,000 for each of fiscal years 2019 through 2023.
p.000159: (f) REPORT TO CONGRESS.—As part of the National Health Se- curity Strategy described in section 2802,
p.000159: the Secretary shall pro- vide an update on the implementation of subsections (a) through (d).
p.000159: SEC. 319C–1. ø247d–3a¿ IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. 17
p.000159: (a) IN GENERAL.—To enhance the security of the United States with respect to public health emergencies, the
p.000159: Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, shall award
p.000159: cooperative agreements to eligible entities to enable such entities to conduct the activities described in
p.000159: sub- section (d).
p.000159: (b) ELIGIBLE ENTITIES.—To be eligible to receive an award under subsection (a), an entity shall—
p.000159: (1)(A) be a State;
p.000159: (B) be a political subdivision determined by the Secretary to be eligible for an award under this section
p.000159: (based on criteria described in subsection (h)(4)); or
p.000159: (C) be a consortium of States; and
...

p.000179: and Advancing Innovation Act of 2019, the Secretary shall convene a public meeting for pur- poses of
p.000179: discussing and providing input on the poten- tial goals, functions, and uses of the network described in
p.000179: paragraph (1) and incorporating the elements de- scribed in paragraph (3)(A).
p.000179: (ii) EXPERTS.—The public meeting shall include representatives of relevant Federal agencies (including
p.000179: representatives from the Office of the National Coordi- nator for Health Information Technology and the Na-
p.000179: tional Institute of Standards and Technology); State, local, Tribal, and territorial public health
p.000179: officials; stakeholders with expertise in biosurveillance and sit- uational awareness; stakeholders with expertise in
p.000179: ca- pabilities relevant to biosurveillance and situational awareness, such as experts in informatics and
p.000179: data analytics (including experts in prediction, modeling, or forecasting); and other representatives as the
p.000179: Sec- retary determines appropriate.
p.000179: (iii) TOPICS.—Such public meeting shall include a discussion of—
p.000179: (I) data elements, including minimal or essen- tial data elements, that are voluntarily provided for such
p.000179: network, which may include elements from public health and public and private health care entities, to the
p.000179: extent practicable;
p.000179: (II) standards and implementation specifica- tions that may improve the collection, analysis, and
p.000179: interpretation of data during a public health emergency;
p.000179: (III) strategies to encourage the access, ex- change, and use of information;
p.000179: (IV) considerations for State, local, Tribal, and territorial capabilities and infrastructure related to data
p.000179: exchange and interoperability;
p.000179: (V) privacy and security protections provided at the Federal, State, local, Tribal, and territorial levels, and by
p.000179: nongovernmental stakeholders; and
p.000179: (VI) opportunities for the incorporation of in- novative technologies to improve the network.
p.000179: (6) STRATEGY AND IMPLEMENTATION PLAN.—
p.000179: (A) IN GENERAL.—Not later than 18 months after the date of enactment of the Pandemic and All-Hazards
p.000179: Pre- paredness and Advancing Innovation Act of 2019, the Sec-
p.000179: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000179:
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p.000181: PUBLIC HEALTH SERVICE ACT
p.000181: Sec. 319D
p.000181:
p.000181: retary shall submit to the congressional committees of ju- risdiction a coordinated strategy and an
p.000181: accompanying im- plementation plan that—
p.000181: (i) is informed by the public meeting under para- graph (5)(B);
p.000181: (ii) includes a review and assessment of existing capabilities of the network and related infrastructure,
p.000181: including input provided by the public meeting under paragraph (5)(B);
p.000181: (iii) identifies and demonstrates the measurable steps the Secretary will carry out to—
p.000181: (I) develop, implement, and evaluate the net- work described in paragraph (1), utilizing ele- ments
p.000181: described in paragraph (3)(A);
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p.000207: (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and
p.000207: (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to
p.000207: affect national security.
p.000207: (B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER- MEASURES.—The Secretary shall on an ongoing basis—
p.000207: (i) assess the potential public health consequences for the United States population of exposure to agents identified
p.000207: under subparagraph (A)(ii); and
p.000207: (ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for
p.000207: which countermeasures are necessary to protect the public health.
p.000207: (C) NOTICE TO CONGRESS.—The Secretary and the Sec- retary of Homeland Security shall send to Congress, on an annual
p.000207: basis, all current material threat determinations and shall promptly notify the Committee on Health, Edu-
p.000207: cation, Labor, and Pensions and the Committee on Home- land Security and Governmental Affairs of the Senate and the
p.000207: Committee on Energy and Commerce and the Com- mittee on Homeland Security of the House of Representa-
p.000207: tives that a determination has been made pursuant to sub- paragraph (A) or (B).
p.000207: (D) ASSURING ACCESS TO THREAT INFORMATION.—In making the assessment and determination required under
p.000207: subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is
p.000207: en- titled under section 202 of the Homeland Security Act of 2002, including but not limited to
p.000207: information, regardless of its level of classification, relating to current and emerg- ing threats of chemical,
p.000207: biological, radiological, and nu- clear agents.
p.000207: (3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF COUNTERMEASURES.—
p.000207: (A) IN GENERAL.—The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongo- ing
p.000207: basis the availability and appropriateness of specific countermeasures to address specific threats
p.000207: identified under paragraph (2).
p.000207: (B) INFORMATION.—The Secretary shall institute a process for making publicly available the results of assess-
p.000207: ments under subparagraph (A) while withholding such in- formation as—
p.000207: (i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
p.000207: (ii) would otherwise be exempt from disclosure under section 552 of title 5, United States Code.
p.000207: (4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COM- MITMENT FOR RECOMMENDATION FOR PROCUREMENT.—
p.000207: (A) PROPOSAL TO THE PRESIDENT.—If, pursuant to an assessment under paragraph (3), the Homeland Security
p.000207: Secretary and the Secretary make a determination that a countermeasure would be appropriate but
p.000207: is either
p.000207: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: services during a public health emergency. Such health care professionals may include members of the National
p.000233: Disaster Medical System, members of the Medical Re- serve Corps, and individual health care professionals.
p.000233: (b) REQUIREMENTS.—The interoperable network of systems es- tablished under subsection (a) (referred to in
p.000233: this section as the ‘‘verification network’’) shall include—
p.000233: (1) with respect to each volunteer health professional in- cluded in the verification network—
p.000233: (A) information necessary for the rapid identification of, and communication with, such professionals; and
p.000233: (B) the credentials, certifications, licenses, and rel- evant training of such individuals; and
p.000233: (2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any
p.000233: other relevant federally-sponsored or administered programs deter- mined necessary by the Secretary.
p.000233: (c) OTHER ASSISTANCE.—The Secretary may make grants and provide technical assistance to States and other public
p.000233: or nonprofit private entities for activities relating to the verification network de- veloped under subsection (a).
p.000233: (d) ACCESSIBILITY.—The Secretary shall ensure that the verification network is electronically accessible by
p.000233: State, local, and tribal health departments and can be linked with the identification cards under section 2813.
p.000233: (e) CONFIDENTIALITY.—The Secretary shall establish and re- quire the application of and compliance with
p.000233: measures to ensure the effective security of, integrity of, and access to the data in- cluded in the
p.000233: verification network.
p.000233: (f) COORDINATION.—The Secretary shall coordinate with the Secretary of Veterans Affairs and the Secretary of
p.000233: Homeland Secu- rity to assess the feasibility of integrating the verification network under this section with the
p.000233: VetPro system of the Department of Veterans Affairs and the National Emergency Responder
p.000233: Credentialing System of the Department of Homeland Security. The Secretary shall, if feasible, integrate
p.000233: the verification network under this section with such VetPro system and the National Emergency Responder
p.000233: Credentialing System.
p.000233: (g) UPDATING OF INFORMATION.—The States that are partici- pants in the verification network shall, on at
p.000233: least a quarterly basis, work with the Director to provide for the updating of the in- formation contained in the
p.000233: verification network.
p.000233: (h) CLARIFICATION.—Inclusion of a health professional in the verification network shall not constitute
p.000233: appointment of such indi-
p.000233: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
p.000257: (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol;
p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
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p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
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p.000259: spe- cific shortages of personal health services of an area or population group. Such criteria shall—
p.000259: (i) take into account comments received by the Secretary from the chief executive officer of a State and
p.000259: local officials in a State; and
p.000259: (ii) include factors indicative of the health status of a population group or residents of an area, the abil-
p.000259: ity of the residents of an area or of a population group to pay for health services and their accessibility to
p.000259: them, and the availability of health professionals to residents of an area or to a population group.
p.000259: (C) LIMITATION.—The Secretary may not designate a medically underserved population in a State or terminate
p.000259: the designation of such a population unless, prior to such designation or termination, the Secretary provides
p.000259: reason- able notice and opportunity for comment and consults with—
p.000259: (i) the chief executive officer of such State;
p.000259: (ii) local officials in such State; and
p.000259: (iii) the organization, if any, which represents a majority of health centers in such State.
p.000259: (D) PERMISSIBLE DESIGNATION.—The Secretary may designate a medically underserved population that does
p.000259: not meet the criteria established under subparagraph (B) if the chief executive officer of the State in which
p.000259: such pop- ulation is located and local officials of such State rec- ommend the designation of such
p.000259: population based on un- usual local conditions which are a barrier to access to or the availability of
p.000259: personal health services.
p.000259: (c) PLANNING GRANTS.—
p.000259: (1) CENTERS.—The Secretary may make grants to public and nonprofit private entities for projects to plan
p.000259: and develop health centers which will serve medically underserved popu- lations. A project for which a
p.000259: grant may be made under this subsection may include the cost of the acquisition and lease of buildings and
p.000259: equipment (including the costs of amortizing the principal of, and paying the interest on, loans) and shall
p.000259: in- clude—
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p.000259: (A) an assessment of the need that the population pro- posed to be served by the health center for which the
p.000259: project is undertaken has for required primary health services and additional health services;
p.000259: (B) the design of a health center program for such pop- ulation based on such assessment;
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000261: PUBLIC HEALTH SERVICE ACT
p.000261: Sec. 330
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p.000261: Bureau of the Census.
p.000261: (d) IMPROVING QUALITY OF CARE.—
p.000261: (1) SUPPLEMENTAL AWARDS.—The Secretary may award supplemental grant funds to health centers funded under
p.000261: this section to implement evidence-based models for increasing ac- cess to high-quality primary care
p.000261: services, which may include models related to—
p.000261: (A) improving the delivery of care for individuals with multiple chronic conditions;
p.000261: (B) workforce configuration;
p.000261: (C) reducing the cost of care;
p.000261: (D) enhancing care coordination;
p.000261: (E) expanding the use of telehealth and technology-en- abled collaborative learning and capacity building models;
p.000261: (F) care integration, including integration of behav- ioral health, mental health, or substance use disorder
p.000261: serv- ices; and
p.000261: (G) addressing emerging public health or substance use disorder issues to meet the health needs of the
p.000261: popu- lation served by the health center.
p.000261: (2) SUSTAINABILITY.—In making supplemental awards under this subsection, the Secretary may consider whether the
p.000261: health center involved has submitted a plan for continuing the activities funded under this subsection after
p.000261: supplemental funding is expended.
p.000261: (3) SPECIAL CONSIDERATION.—The Secretary may give spe- cial consideration to applications for supplemental
p.000261: funding under this subsection that seek to address significant barriers to access to care in areas with a
p.000261: greater shortage of health care providers and health services relative to the national average.
p.000261: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000261: Sec. 330 PUBLIC HEALTH SERVICE ACT 262
p.000261:
p.000261: (e) OPERATING GRANTS.—
p.000261: (1) AUTHORITY.—
p.000261: (A) IN GENERAL.—The Secretary may make grants for the costs of the operation of public and nonprofit
p.000261: private health centers that provide health services to medically underserved populations.
p.000261: (B) ENTITIES THAT FAIL TO MEET CERTAIN REQUIRE- MENTS.—The Secretary may make grants, for a period
p.000261: of not to exceed 1 year, for the costs of the operation of public and nonprofit private entities which provide
p.000261: health serv- ices to medically underserved populations but with respect to which the Secretary is unable to make each
p.000261: of the deter- minations required by subsection (k)(3). The Secretary shall not make a grant under
p.000261: this paragraph unless the applicant provides assurances to the Secretary that within 120 days of receiving grant
p.000261: funding for the operation of the health center, the applicant will submit, for approval by the Secretary, an
p.000261: implementation plan to meet the re- quirements of subsection (k)(3). The Secretary may extend such 120-day period
p.000261: for achieving compliance upon a dem- onstration of good cause by the health center.
p.000261: (C) OPERATION OF NETWORKS.—The Secretary may make grants to health centers that receive
p.000261: assistance under this section, or at the request of the health centers, directly to a network that is at least
p.000261: majority controlled and, as applicable, at least majority owned by such health centers receiving assistance under
p.000261: this section, for the costs associated with the operation of such network includ- ing—
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p.000261: (i) the purchase or lease of equipment, which may include data and information systems (including the costs of
p.000261: amortizing the principal of, and paying the in- terest on, loans for equipment);
p.000261: (ii) the provision of training and technical assist- ance; and
p.000261: (iii) other activities that—
p.000261: (I) reduce costs associated with the provision of health services;
p.000261: (II) improve access to, and availability of, health services provided to individuals served by the
p.000261: centers;
p.000261: (III) enhance the quality and coordination of health services; or
p.000261: (IV) improve the health status of commu- nities.
p.000261: (2) USE OF FUNDS.—The costs for which a grant may be made under subparagraph (A) or (B) of paragraph
p.000261: (1) may in- clude the costs of acquiring and leasing buildings and equip- ment (including the costs of
p.000261: amortizing the principal of, and paying interest on, loans), and the costs of providing training related
p.000261: to the provision of required primary health services and additional health services and to the
p.000261: management of health center programs.
p.000261: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000263: PUBLIC HEALTH SERVICE ACT
p.000263: Sec. 330
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p.000263: same entity.
p.000263: (5) AMOUNT.—
p.000263: (A) IN GENERAL.—The amount of any grant made in any fiscal year under subparagraphs (A) and (B) of
p.000263: para- graph (1) to a health center shall be determined by the Secretary, but may not exceed the amount
p.000263: by which the costs of operation of the center in such fiscal year exceed the total of—
p.000263: (i) State, local, and other operational funding pro- vided to the center; and
p.000263: (ii) the fees, premiums, and third-party reimburse- ments, which the center may reasonably be expected to
p.000263: receive for its operations in such fiscal year.
p.000263: (B) NETWORKS.—The total amount of grant funds made available for any fiscal year under paragraph
p.000263: (1)(C) to a health center or to a network shall be determined by the Secretary, but may not exceed 2 percent of
p.000263: the total amount appropriated under this section for such fiscal year.
p.000263: (C) PAYMENTS.—Payments under grants under sub- paragraph (A) or (B) of paragraph (1) shall be made in ad- vance
p.000263: or by way of reimbursement and in such install- ments as the Secretary finds necessary and adjustments
p.000263: may be made for overpayments or underpayments.
p.000263: (D) USE OF NONGRANT FUNDS.—Nongrant funds de- scribed in clauses (i) and (ii) of subparagraph (A),
p.000263: includ- ing any such funds in excess of those originally expected, shall be used as permitted under this
p.000263: section, and may be used for such other purposes as are not specifically prohib- ited under this section if such
p.000263: use furthers the objectives of the project.
p.000263: (6) NEW ACCESS POINTS AND EXPANDED SERVICES.—
p.000263: (A) APPROVAL OF NEW ACCESS POINTS.—
p.000263: (i) IN GENERAL.—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph
p.000263: (1) to establish new delivery sites.
p.000263: (ii) SPECIAL CONSIDERATION.—In carrying out clause (i), the Secretary may give special consideration to
p.000263: applicants that have demonstrated the new delivery site will be located within a sparsely populated area, or
p.000263: an area which has a level of unmet need that is higher relative to other applicants.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000267: risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse 31 provided
p.000267: in settings other than hospitals.
p.000267: (i) RESIDENTS OF PUBLIC HOUSING.—
p.000267: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000267: the plan- ning and delivery of services to a special medically under- served population comprised of
p.000267: residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term
p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
p.000267: (2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under this subsection shall be expended to supplement, and not
p.000267: sup- plant, the expenditures of the health center and the value of in kind contributions for the
p.000267: delivery of services to the popu- lation described in paragraph (1).
p.000267: (3) CONSULTATION WITH RESIDENTS.—The Secretary may not make a grant under paragraph (1) unless, with
p.000267: respect to the residents of the public housing involved, the applicant for the grant—
p.000267: (A) has consulted with the residents in the prepara- tion of the application for the grant; and
p.000267: (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the
p.000267: program carried out with the grant.
p.000267: (j) ACCESS GRANTS.—
p.000267: (1) IN GENERAL.—The Secretary may award grants to eligi- ble health centers with a substantial number of
p.000267: clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services
p.000267: for such clients with lim- ited English speaking proficiency.
p.000267: (2) ELIGIBLE HEALTH CENTER.—In this subsection, the term ‘‘eligible health center’’ means an entity that—
p.000267: (A) is a health center as defined under subsection (a);
p.000267: (B) provides health care services for clients for whom English is a second language; and
p.000267: (C) has exceptional needs with respect to linguistic ac- cess or faces exceptional challenges with respect to
p.000267: lin- guistic access.
p.000267: (3) GRANT AMOUNT.—The amount of a grant awarded to a center under this subsection shall be determined by the
p.000267: Ad- ministrator. Such determination of such amount shall be based on the number of clients for whom English is
p.000267: a second lan- guage that is served by such center, and larger grant amounts shall be awarded to centers serving
p.000267: larger numbers of such cli- ents.
p.000267:
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p.000267: January 30, 2020
p.000267: 31 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amend- ment to
p.000267: strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such, the amendment has not been
p.000267: carried out above.
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000267:
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p.000267: Sec. 330 PUBLIC HEALTH SERVICE ACT 268
p.000267:
p.000267: (4) USE OF FUNDS.—An eligible health center that receives a grant under this subsection may use funds received
p.000267: through such grant to—
p.000267: (A) provide translation, interpretation, and other such services for clients for whom English is a second language,
p.000267: including hiring professional translation and interpreta- tion services; and
p.000267: (B) compensate bilingual or multilingual staff for lan- guage assistance services provided by the staff for such
p.000267: cli- ents.
p.000267: (5) APPLICATION.—An eligible health center desiring a grant under this subsection shall submit an
p.000267: application to the Secretary at such time, in such manner, and containing such information as the Secretary
p.000267: may reasonably require, includ- ing—
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p.000267: (A) an estimate of the number of clients that the cen- ter serves for whom English is a second language;
p.000267: (B) the ratio of the number of clients for whom English is a second language to the total number of
p.000267: clients served by the center;
p.000267: (C) a description of any language assistance services that the center proposes to provide to aid clients for
p.000267: whom English is a second language; and
p.000267: (D) a description of the exceptional needs of such cen- ter with respect to linguistic access or a description of the
p.000267: exceptional challenges faced by such center with respect to linguistic access.
p.000267: (6) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, in
p.000267: addition to any funds authorized to be appropriated or appropriated for health centers under any other subsection of
p.000267: this section, such sums as may be necessary for each of fiscal years 2002 through 2006.
p.000267: (k) APPLICATIONS.—
p.000267: (1) SUBMISSION.—No grant may be made under this sec- tion unless an application therefore is submitted
p.000267: to, and ap- proved by, the Secretary. Such an application shall be sub- mitted in such form and manner and
p.000267: shall contain such infor- mation as the Secretary shall prescribe.
p.000267: (2) DESCRIPTION OF UNMET NEED.—An application for a grant under subparagraph (A) or (B) of subsection (e)(1)
p.000267: or sub- section (e)(6) for a health center shall include—
p.000267: (A) a description of the unmet need for health services in the catchment area of the center;
p.000267: (B) a demonstration by the applicant that the area or the population group to be served by the applicant has
p.000267: a shortage of personal health services;
p.000267: (C) a demonstration that the center will be located so that it will provide services to the greatest number of
p.000267: indi- viduals residing in the catchment area or included in such population group; and
p.000267: (D) in the case of an application for a grant pursuant to subsection (e)(6), a demonstration that the
p.000267: applicant has consulted with appropriate State and local government
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000271: application or if the governing body has not approved the application, the failure of the governing body
p.000271: to approve the application was unreasonable;
p.000271: except that, upon a showing of good cause the Secretary shall waive, for the length of the project period, all
p.000271: or part of the requirements of this subparagraph in the case of a health center that receives a grant
p.000271: pursuant to subsection (g), (h), (i), or (p);
p.000271: (I) the center has developed—
p.000271: (i) an overall plan and budget that meets the re- quirements of the Secretary; and
p.000271: (ii) an effective procedure for compiling and re- porting to the Secretary such statistics and other in-
p.000271: formation as the Secretary may require relating to—
p.000271: (I) the costs of its operations;
p.000271: (II) the patterns of use of its services;
p.000271: (III) the availability, accessibility, and accept- ability of its services; and
p.000271: (IV) such other matters relating to operations of the applicant as the Secretary may require;
p.000271: (J) the center will review periodically its catchment area to—
p.000271: (i) ensure that the size of such area is such that the services to be provided through the center (includ-
p.000271: ing any satellite) are available and accessible to the residents of the area promptly and as appropriate;
p.000271: (ii) ensure that the boundaries of such area con- form, to the extent practicable, to relevant boundaries of
p.000271: political subdivisions, school districts, and Federal and State health and social service programs; and
p.000271: (iii) ensure that the boundaries of such area elimi- nate, to the extent possible, barriers to access to the
p.000271: services of the center, including barriers resulting from the area’s physical characteristics, its
p.000271: residential patterns, its economic and social grouping, and avail- able transportation;
p.000271: (K) in the case of a center which serves a population including a substantial proportion of individuals of
p.000271: limited English-speaking ability, the center has—
p.000271: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000271: Sec. 330 PUBLIC HEALTH SERVICE ACT 272
p.000271: (i) developed a plan and made arrangements re- sponsive to the needs of such population for providing services
p.000271: to the extent practicable in the language and cultural context most appropriate to such individuals; and
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p.000275: (B) DISTRIBUTION OF GRANTS.—For fiscal year 2002 and each of the following fiscal years, the
p.000275: Secretary, in awarding grants under this section, shall ensure that the proportion of the amount made
p.000275: available under each of subsections (g), (h), and (i), relative to the total amount ap- propriated to carry out
p.000275: this section for that fiscal year, is equal to the proportion of the amount made available under that
p.000275: subsection for fiscal year 2001, relative to the total amount appropriated to carry out this section for fis-
p.000275: cal year 2001.
p.000275: (3) FUNDING REPORT.—The Secretary shall annually pre- pare and submit to the Committee on Health,
p.000275: Education, Labor, and Pensions of the Senate, and the Committee on En- ergy and Commerce of the House of
p.000275: Representatives, a report including, at a minimum—
p.000275: (A) the distribution of funds for carrying out this sec- tion that are provided to meet the health
p.000275: care needs of medically underserved populations, including the home- less, residents of public housing, and
p.000275: migratory and sea- sonal agricultural workers, and the appropriateness of the delivery systems involved in
p.000275: responding to the needs of the particular populations;
p.000275: (B) an assessment of the relative health care access needs of the targeted populations;
p.000275: (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban
p.000275: areas;
p.000275: (D) the distribution of awards and funding for estab- lishing new access points, and the number of new
p.000275: access points created;
p.000275: (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI;
p.000275: (F) the rationale for any substantial changes in the distribution of funds;
p.000275: (G) the rate of closures for health centers and access points;
p.000275: (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and
p.000275: (I) the number and reason for any waivers provided pursuant to subsection (q)(4).
p.000275: (4) RULE OF CONSTRUCTION WITH RESPECT TO RURAL HEALTH CLINICS.—
p.000275: (A) IN GENERAL.—Nothing in this section shall be con- strued to prevent a community health center from con-
p.000275: tracting with a Federally certified rural health clinic (as defined in section 1861(aa)(2) of the Social
p.000275: Security Act), a low-volume hospital (as defined for purposes of section 1886 of such Act), a critical access
p.000275: hospital, a sole commu- nity hospital (as defined for purposes of section 1886(d)(5)(D)(iii) of
p.000275: such Act), or a medicare-dependent share hospital (as defined for purposes of section
p.000275: 1886(d)(5)(G)(iv) of such Act) for the delivery of primary health care services that are available at the
p.000275: clinic or hos- pital to individuals who would otherwise be eligible for free or reduced cost care if that
p.000275: individual were able to ob-
p.000275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000275: Sec. 330A PUBLIC HEALTH SERVICE ACT 276
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p.000275: January 30, 2020
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p.000275: tain that care at the community health center. Such serv- ices may be limited in scope to those primary health
p.000275: care services available in that clinic or hospitals.
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p.000275: profes- sional shortage area designated under section 332.
p.000275: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ has the meaning given
p.000275: the term in section 799B(6).
p.000275: (5) MEDICALLY UNDERSERVED POPULATION.—The term ‘‘medically underserved population’’ has the meaning given
p.000275: the term in section 330(b)(3).
p.000275: (c) PROGRAM.—The Secretary shall establish, under section 301, a small health care provider quality
p.000275: improvement grant pro- gram.
p.000275: (d) ADMINISTRATION.—
p.000275: (1) PROGRAMS.—The rural health care services outreach, rural health network development, and small health
p.000275: care pro- vider quality improvement grant programs established under section 301 shall be administered by the
p.000275: Director of the Office
p.000275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000277: 277
p.000277: PUBLIC HEALTH SERVICE ACT
p.000277: Sec. 330A
p.000277:
p.000277: of Rural Health Policy of the Health Resources and Services Administration, in consultation with State
p.000277: offices of rural health or other appropriate State government entities.
p.000277: (2) GRANTS.—
p.000277: (A) IN GENERAL.—In carrying out the programs de- scribed in paragraph (1), the Director may award grants
p.000277: under subsections (e), (f), and (g) to expand access to, co- ordinate, and improve the quality of
p.000277: essential health care services, and enhance the delivery of health care, in rural areas.
p.000277: (B) TYPES OF GRANTS.—The Director may award the grants—
p.000277: (i) to promote expanded delivery of health care services in rural areas under subsection (e);
p.000277: (ii) to provide for the planning and implementa- tion of integrated health care networks in rural areas under
p.000277: subsection (f); and
p.000277: (iii) to provide for the planning and implementa- tion of small health care provider quality improvement
p.000277: activities under subsection (g).
p.000277: (e) RURAL HEALTH CARE SERVICES OUTREACH GRANTS.—
p.000277: (1) GRANTS.—The Director may award grants to eligible entities to promote rural health care services
p.000277: outreach by ex- panding the delivery of health care services to include new and enhanced services in rural areas. The
p.000277: Director may award the grants for periods of not more than 3 years.
p.000277: (2) ELIGIBILITY.—To be eligible to receive a grant under this subsection for a project, an entity—
p.000277: (A) shall be a rural public or rural nonprofit private entity;
p.000277: (B) shall represent a consortium composed of mem- bers—
p.000277:
p.000277: and and
p.000277: (i) that include 3 or more health care providers;
p.000277: (ii) that may be nonprofit or for-profit entities;
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p.000277: (C) shall not previously have received a grant under
p.000277: this subsection for the same or a similar project, unless the entity is proposing to expand the scope of the
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p.000277: require, including—
p.000277: (A) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000277: (B) a description of the manner in which the project funded under the grant will meet the health care needs of
p.000277: rural underserved populations in the local community or region to be served;
p.000277: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000277: Sec. 330A PUBLIC HEALTH SERVICE ACT 278
p.000277:
p.000277: (C) a description of how the local community or region to be served will be involved in the development and ongo- ing
p.000277: operations of the project;
p.000277: (D) a plan for sustaining the project after Federal sup- port for the project has ended;
p.000277: (E) a description of how the project will be evaluated;
p.000277: and
p.000277: (F) other such information as the Secretary deter-
p.000277: mines to be appropriate.
p.000277: (f) RURAL HEALTH NETWORK DEVELOPMENT GRANTS.—
p.000277: (1) GRANTS.—
p.000277: (A) IN GENERAL.—The Director may award rural health network development grants to eligible entities
p.000277: to promote, through planning and implementation, the devel- opment of integrated health care networks that have com-
p.000277: bined the functions of the entities participating in the net- works in order to—
p.000277: (i) achieve efficiencies;
p.000277: (ii) expand access to, coordinate, and improve the quality of essential health care services; and
p.000277: (iii) strengthen the rural health care system as a whole.
p.000277: (B) GRANT PERIODS.—The Director may award such a rural health network development grant for implementa-
p.000277: tion activities for a period of 3 years. The Director may also award such a rural health network development
p.000277: grant for planning activities for a period of 1 year, to assist in the development of an integrated
p.000277: health care network, if the proposed participants in the network do not have a history of collaborative
p.000277: efforts and a 3-year grant would be inappropriate.
p.000277: (2) ELIGIBILITY.—To be eligible to receive a grant under this subsection, an entity—
p.000277: (A) shall be a rural public or rural nonprofit private entity;
p.000277: (B) shall represent a network composed of partici- pants—
p.000277:
p.000277: and and
p.000277: (i) that include 3 or more health care providers;
p.000277: (ii) that may be nonprofit or for-profit entities;
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p.000277: (C) shall not previously have received a grant under this subsection (other than a grant for planning
p.000277: activities) for the same or a similar project.
p.000277: (3) APPLICATIONS.—To be eligible to receive a grant under this subsection, an eligible entity, in consultation with the
p.000277: ap- propriate State office of rural health or another appropriate State entity, shall prepare and submit to the
p.000277: Secretary an ap- plication, at such time, in such manner, and containing such information as the Secretary may
p.000277: require, including—
p.000277: (A) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000277: (B) an explanation of the reasons why Federal assist- ance is required to carry out the project;
p.000277: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000279: PUBLIC HEALTH SERVICE ACT
p.000279: Sec. 330A
p.000279:
p.000279: (C) a description of—
p.000279: (i) the history of collaborative activities carried out by the participants in the network;
p.000279: (ii) the degree to which the participants are ready to integrate their functions; and
p.000279: (iii) how the local community or region to be served will benefit from and be involved in the activi-
p.000279: ties carried out by the network;
p.000279: (D) a description of how the local community or region to be served will experience increased access to quality
p.000279: health care services across the continuum of care as a re- sult of the integration activities carried
p.000279: out by the net- work;
p.000279: (E) a plan for sustaining the project after Federal sup- port for the project has ended;
p.000279: (F) a description of how the project will be evaluated;
p.000279: and
p.000279: (G) other such information as the Secretary deter-
p.000279: mines to be appropriate.
p.000279: (g) SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT GRANTS.—
p.000279: (1) GRANTS.—The Director may award grants to provide for the planning and implementation of small health care
p.000279: pro- vider quality improvement activities. The Director may award the grants for periods of 1 to 3 years.
p.000279: (2) ELIGIBILITY.—To be eligible for a grant under this sub- section, an entity—
p.000279: (A)(i) shall be a rural public or rural nonprofit private health care provider or provider of health care
p.000279: services, such as a critical access hospital or a rural health clinic; or
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p.000279: (ii) shall be another rural provider or network of small rural providers identified by the Secretary as a key source of
p.000279: local care; and
p.000279: (B) shall not previously have received a grant under this subsection for the same or a similar project.
p.000279: (3) APPLICATIONS.—To be eligible to receive a grant under this subsection, an eligible entity, in consultation with the
p.000279: ap- propriate State office of rural health or another appropriate State entity shall prepare and submit
p.000279: to the Secretary an ap- plication, at such time, in such manner, and containing such information as the
p.000279: Secretary may require, including—
p.000279: (A) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000279: (B) an explanation of the reasons why Federal assist- ance is required to carry out the project;
p.000279: (C) a description of the manner in which the project funded under the grant will assure continuous quality im-
p.000279: provement in the provision of services by the entity;
p.000279: (D) a description of how the local community or region to be served will experience increased access to quality
p.000279: health care services across the continuum of care as a re- sult of the activities carried out by the entity;
p.000279: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000279: Sec. 330A–1 PUBLIC HEALTH SERVICE ACT 280
p.000279: (E) a plan for sustaining the project after Federal sup- port for the project has ended;
p.000279: (F) a description of how the project will be evaluated;
p.000279: and
p.000279: (G) other such information as the Secretary deter-
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p.000279: mines to be appropriate.
p.000279: (4) EXPENDITURES FOR SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT GRANTS.—In awarding a grant
p.000279: under this subsection, the Director shall ensure that the funds made available through the grant will be used to
p.000279: provide services to residents of rural areas. The Director shall award not less than 50 percent of the funds made
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p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000283: (3) COORDINATION OF ACTIVITIES.—The Secretary shall en- sure that activities under this subsection are
p.000283: coordinated as appropriate with other agencies of the Public Health Service that carry out activities
p.000283: regarding epilepsy and seizure.
p.000283: (b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDI-
p.000283: CALLY UNDERSERVED AREAS.—
p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000283: Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access
p.000283: to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others
p.000283: residing in medically underserved areas.
p.000283: (2) APPLICATION FOR GRANT.—A grant may not be awarded under paragraph (1) unless an application therefore is
p.000283: sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted
p.000283: in such form and manner and shall contain such information as the Secretary may prescribe.
p.000283: (c) DEFINITIONS.—For purposes of this section:
p.000283: (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive
p.000283: electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may
p.000283: revise the definition of such term to the extent the Secretary determines necessary.
p.000283: (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6).
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000283: SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
p.000283: (a) INFANT ADOPTION AWARENESS.—
p.000283: (1) IN GENERAL.—The Secretary shall make grants to na- tional, regional, or local adoption organizations for
p.000283: the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers
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p.000291: January 30, 2020
p.000291: (7) TELEHEALTH TECHNOLOGIES.—The term ‘‘telehealth technologies’’ means technologies relating to the use
p.000291: of elec- tronic information, and telecommunications technologies, to support and promote, at a
p.000291: distance, health care, patient and professional health-related education, health administration, and public
p.000291: health.
p.000291: (b) PROGRAMS.—The Secretary shall establish, under section 301, telehealth network and telehealth resource
p.000291: centers grant pro- grams.
p.000291: (c) ADMINISTRATION.—
p.000291: (1) ESTABLISHMENT.—There is established in the Health Resources and Services Administration an Office for
p.000291: the Ad- vancement of Telehealth. The Office shall be headed by a Di- rector.
p.000291: (2) DUTIES.—The telehealth network and telehealth re- source centers grant programs established under
p.000291: section 301 shall be administered by the Director, in consultation with the State offices of rural health, State
p.000291: offices concerning primary care, or other appropriate State government entities.
p.000291: (d) GRANTS.—
p.000291: (1) TELEHEALTH NETWORK GRANTS.—The Director may, in carrying out the telehealth network grant program referred to
p.000291: in subsection (b), award grants to eligible entities for projects to demonstrate how telehealth
p.000291: technologies can be used through telehealth networks in rural areas, frontier commu- nities, and medically
p.000291: underserved areas, and for medically un- derserved populations, to—
p.000291: (A) expand access to, coordinate, and improve the quality of health care services;
p.000291: (B) improve and expand the training of health care providers; and
p.000291: (C) expand and improve the quality of health informa- tion available to health care providers, and patients and
p.000291: their families, for decisionmaking.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—The Director may, in carrying out the telehealth resource centers grant pro-
p.000291: gram referred to in subsection (b), award grants to eligible en- tities for projects to demonstrate how
p.000291: telehealth technologies can be used in the areas and communities, and for the popu- lations, described in
p.000291: paragraph (1), to establish telehealth re- source centers.
p.000291: (e) GRANT PERIODS.—The Director may award grants under this section for periods of not more than 4 years.
p.000291: (f) ELIGIBLE ENTITIES.—
p.000291: (1) TELEHEALTH NETWORK GRANTS.—
p.000291: (A) GRANT RECIPIENT.—To be eligible to receive a grant under subsection (d)(1), an entity shall be
p.000291: a non- profit entity.
p.000291: (B) TELEHEALTH NETWORKS.—
p.000291: (i) IN GENERAL.—To be eligible to receive a grant under subsection (d)(1), an entity shall demonstrate
p.000291: that the entity will provide services through a tele- health network.
p.000291: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000291: Sec. 330I PUBLIC HEALTH SERVICE ACT 292
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p.000291: (ii) NATURE OF ENTITIES.—Each entity partici- pating in the telehealth network may be a nonprofit or
p.000291: for-profit entity.
p.000291: (iii) COMPOSITION OF NETWORK.—The telehealth network shall include at least 2 of the following enti- ties
p.000291: (at least 1 of which shall be a community-based health care provider):
p.000291: (I) Community or migrant health centers or other Federally qualified health centers.
p.000291: (II) Health care providers, including phar- macists, in private practice.
p.000291: (III) Entities operating clinics, including rural health clinics.
p.000291: (IV) Local health departments.
p.000291: (V) Nonprofit hospitals, including community access hospitals.
p.000291: (VI) Other publicly funded health or social service agencies.
p.000291: (VII) Long-term care providers.
p.000291: (VIII) Providers of health care services in the home.
p.000291: (IX) Providers of outpatient mental health services and entities operating outpatient mental health
p.000291: facilities.
p.000291: (X) Local or regional emergency health care providers.
p.000291: (XI) Institutions of higher education.
p.000291: (XII) Entities operating dental clinics.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—To be eligi- ble to receive a grant under subsection (d)(2), an
p.000291: entity shall be a nonprofit entity.
p.000291: (g) APPLICATIONS.—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation
p.000291: with the appropriate State office of rural health or another appropriate State entity, shall prepare and
p.000291: submit to the Secretary an application, at such time, in such manner, and containing such information as the
p.000291: Sec- retary may require, including—
p.000291: (1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000291: (2) a description of the manner in which the project funded under the grant will meet the health care needs of
p.000291: rural or other populations to be served through the project, or improve the access to services of, and the
p.000291: quality of the services re- ceived by, those populations;
p.000291: (3) evidence of local support for the project, and a descrip- tion of how the areas, communities, or populations to be
p.000291: served will be involved in the development and ongoing operations of the project;
p.000291: (4) a plan for sustaining the project after Federal support for the project has ended;
p.000291: (5) information on the source and amount of non-Federal funds that the entity will provide for the project;
p.000291: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000293: PUBLIC HEALTH SERVICE ACT
p.000293: Sec. 330I
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p.000293: (6) information demonstrating the long-term viability of the project, and other evidence of institutional
p.000293: commitment of the entity to the project;
p.000293: (7) in the case of an application for a project involving a telehealth network, information demonstrating
p.000293: how the project will promote the integration of telehealth technologies into the operations of health care
p.000293: providers, to avoid redundancy, and improve access to and the quality of care; and
p.000293: (8) other such information as the Secretary determines to be appropriate.
p.000293: (h) TERMS; CONDITIONS; MAXIMUM AMOUNT OF ASSISTANCE.— The Secretary shall establish the terms and
p.000293: conditions of each grant program described in subsection (b) and the maximum amount of a grant to be
p.000293: awarded to an individual recipient for each fiscal year under this section. The Secretary shall publish, in a
p.000293: publication of the Health Resources and Services Administration, notice of the application requirements for
p.000293: each grant program de- scribed in subsection (b) for each fiscal year.
p.000293: (i) PREFERENCES.—
p.000293: (1) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for projects involving telehealth networks,
p.000293: the Secretary shall give preference to an eligible entity that meets at least 1 of the following requirements:
p.000293: (A) ORGANIZATION.—The eligible entity is a rural com- munity-based organization or another community-based or-
p.000293: ganization.
p.000293: (B) SERVICES.—The eligible entity proposes to use Fed- eral funds made available through such a grant to develop plans
p.000293: for, or to establish, telehealth networks that provide mental health, public health, long-term care, home care,
p.000293: preventive, case management services, or prenatal care for high-risk pregnancies.
p.000293: (C) COORDINATION.—The eligible entity demonstrates how the project to be carried out under the grant will
p.000293: be coordinated with other relevant federally funded projects in the areas, communities, and populations to
p.000293: be served through the grant.
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p.000293: (iii) health care professional education; and
p.000293: (iv) rural residency support programs.
p.000293: (j) DISTRIBUTION OF FUNDS.—
p.000293: (1) IN GENERAL.—In awarding grants under this section, the Director shall ensure, to the greatest extent
p.000293: possible, that such grants are equitably distributed among the geographical regions of the United States.
p.000293: (2) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for a fiscal year, the Director shall
p.000293: ensure that—
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p.000293: (A) not less than 50 percent of the funds awarded shall be awarded for projects in rural areas; and
p.000293: (B) the total amount of funds awarded for such projects for that fiscal year shall be not less than the
p.000293: total amount of funds awarded for such projects for fiscal year 2001 under section 330A (as in effect on the
p.000293: day before the date of enactment of the Health Care Safety Net Amend- ments of 2002).
p.000293: (k) USE OF FUNDS.—
p.000293: (1) TELEHEALTH NETWORK PROGRAM.—The recipient of a grant under subsection (d)(1) may use funds received
p.000293: through such grant for salaries, equipment, and operating or other costs, including the cost of—
p.000293: (A) developing and delivering clinical telehealth serv- ices that enhance access to community-based health
p.000293: care services in rural areas, frontier communities, or medically underserved areas, or for medically
p.000293: underserved popu- lations;
p.000293: (B) developing and acquiring, through lease or pur- chase, computer hardware and software, audio and
p.000293: video equipment, computer network equipment, interactive equipment, data terminal equipment, and other
p.000293: equipment that furthers the objectives of the telehealth network grant program;
p.000293: (C)(i) developing and providing distance education, in a manner that enhances access to care in rural areas,
p.000293: fron-
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p.000295: Sec. 330I
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p.000295: tier communities, or medically underserved areas, or for medically underserved populations; or
p.000295: (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro-
p.000295: viders, in a manner that enhances access to care in the areas and communities, or for the populations,
p.000295: described in clause (i);
p.000295: (D) developing and acquiring instructional program- ming;
p.000295: (E)(i) providing for transmission of medical data, and maintenance of equipment; and
p.000295: (ii) providing for compensation (including travel ex- penses) of specialists, and referring health care
p.000295: providers, who are providing telehealth services through the tele- health network, if no third party
p.000295: payment is available for the telehealth services delivered through the telehealth network;
p.000295: (F) developing projects to use telehealth technology to facilitate collaboration between health care providers;
p.000295: (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the
p.000295: telehealth serv- ices; and
p.000295: (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined
p.000295: by the Secretary.
p.000295: (2) TELEHEALTH RESOURCE CENTERS.—The recipient of a grant under subsection (d)(2) may use funds received
p.000295: through such grant for salaries, equipment, and operating or other costs for—
p.000295: (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care
p.000295: pro- viders and a range of health care entities that provide or will provide telehealth services;
p.000295: (B) disseminating information and research findings related to telehealth services;
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p.000299: (d) EQUITABLE DISTRIBUTION.—In awarding grants under this section, the Secretary shall ensure, to the greatest
p.000299: extent possible, that such grants are equitably distributed among geographical re- gions of the United States.
p.000299: (e) APPLICATION.—An entity that desires a grant under this section shall submit an application to the
p.000299: Secretary at such time, in such manner, and containing such information as the Secretary determines to be
p.000299: reasonable.
p.000299: (f) REPORT.—Not later than 4 years after the date of enactment of the Health Care Safety Net Amendments of 2002, the
p.000299: Secretary shall prepare and submit to the appropriate committees of Con- gress a report that shall
p.000299: evaluate activities funded with grants under this section.
p.000299: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000299: $20,000,000 for fiscal year 2002 and such sums as may be necessary for fiscal years 2003 through 2006.
p.000299: SEC. 330L. ø254c–18¿ TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG STATES.
p.000299: (a) IN GENERAL.—The Secretary may make grants to State pro- fessional licensing boards to carry out programs under
p.000299: which such licensing boards of various States cooperate to develop and imple- ment State policies that
p.000299: will reduce statutory and regulatory bar- riers to telemedicine.
p.000299: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out subsection (a), there are authorized to be
p.000299: appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.
p.000299: SEC. 330M 37 ø254c–19¿ PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
p.000299: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000299: Administration and in coordination with other relevant Federal agencies, shall award grants to States, political
p.000299: subdivisions of States, and Indian tribes and tribal organizations (for purposes of this section, as such terms are
p.000299: defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act (25 U.S.C. 450b)) to
p.000299: promote behavioral health integration in pediatric primary care by—
p.000299: (1) supporting the development of statewide or regional pe- diatric mental health care telehealth access programs; and
p.000299: (2) supporting the improvement of existing statewide or re- gional pediatric mental health care telehealth access
p.000299: programs.
p.000299: (b) PROGRAM REQUIREMENTS.—
p.000299: (1) IN GENERAL.—A pediatric mental health care telehealth access program referred to in subsection (a), with
p.000299: respect to which a grant under such subsection may be used, shall—
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p.000301: Sec. 330M
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p.000301: (A) be a statewide or regional network of pediatric mental health teams that provide support to pediatric pri-
p.000301: mary care sites as an integrated team;
p.000301: (B) support and further develop organized State or re- gional networks of pediatric mental health teams to pro-
p.000301: vide consultative support to pediatric primary care sites;
p.000301: (C) conduct an assessment of critical behavioral con- sultation needs among pediatric providers and such
p.000301: pro- viders’ preferred mechanisms for receiving consultation, training, and technical assistance;
p.000301: (D) develop an online database and communication mechanisms, including telehealth, to facilitate consultation
p.000301: support to pediatric practices;
p.000301: (E) provide rapid statewide or regional clinical tele- phone or telehealth consultations when requested between
p.000301: the pediatric mental health teams and pediatric primary care providers;
p.000301: (F) conduct training and provide technical assistance to pediatric primary care providers to support the
p.000301: early identification, diagnosis, treatment, and referral of chil- dren with behavioral health conditions;
p.000301: (G) provide information to pediatric providers about, and assist pediatric providers in accessing,
p.000301: pediatric men- tal health care providers, including child and adolescent psychiatrists, and licensed
p.000301: mental health professionals, such as psychologists, social workers, or mental health counselors and in
p.000301: scheduling and conducting technical as- sistance;
p.000301: (H) assist with referrals to specialty care and commu- nity or behavioral health resources; and
p.000301: (I) establish mechanisms for measuring and moni- toring increased access to pediatric mental health
p.000301: care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to
p.000301: identify, treat, and refer children with mental health problems.
p.000301: (2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, the term ‘‘pediatric mental health team’’ means a
p.000301: team con- sisting of at least one case coordinator, at least one child and adolescent psychiatrist, and at
p.000301: least one licensed clinical men- tal health professional, such as a psychologist, social worker, or mental
p.000301: health counselor. Such a team may be regionally based.
p.000301: (c) APPLICATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization seeking a
p.000301: grant under this section shall submit an application to the Secretary at such time, in such manner, and
p.000301: containing such information as the Secretary may re- quire, including a plan for the comprehensive evaluation
p.000301: of activi- ties that are carried out with funds received under such grant.
p.000301: (d) EVALUATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization that
p.000301: receives a grant under this section shall prepare and submit an evaluation of activities that are carried
p.000301: out with funds received under such grant to the Sec- retary at such time, in such manner, and containing such
p.000301: informa-
p.000301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000301:
p.000301:
p.000301:
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p.000301: Sec. 331 PUBLIC HEALTH SERVICE ACT 302
p.000301:
p.000301: tion as the Secretary may reasonably require, including a process and outcome evaluation.
p.000301: (e) ACCESS TO BROADBAND.—In administering grants under this section, the Secretary may coordinate with
p.000301: other agencies to ensure that funding opportunities are available to support access to reliable, high-speed
p.000301: Internet for providers.
p.000301: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section unless the State, political
p.000301: subdivision of a State, Indian tribe, or tribal organization involved agrees, with re- spect to the costs to be
p.000301: incurred by the State, political subdivision of a State, Indian tribe, or tribal organization in carrying out
p.000301: the purpose described in this section, to make available non-Federal contributions (in cash or in kind)
p.000301: toward such costs in an amount that is not less than 20 percent of Federal funds provided in the
p.000301: grant.
p.000301: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated, $9,000,000
p.000301: for the pe- riod of fiscal years 2018 through 2022.
p.000301: Subpart II—National Health Service Corps Program
p.000301: NATIONAL HEALTH SERVICE CORPS
p.000301: SEC. 331. ø254d¿ (a)(1) For the purpose of eliminating health manpower 38 shortages in health professional
p.000301: shortage areas, there is established, within the Service, the National Health Service Corps, which shall
p.000301: consist of—
p.000301: (A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
p.000301: (B) such civilian employees of the United States as the Secretary may appoint, and
p.000301: (C) such other individuals who are not employees of the United States.
p.000301: (2) The Corps shall be utilized by the Secretary to provide pri- mary health services in health professional shortage
p.000301: areas.
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p.000311: approved by the Secretary. Such an application shall be in such form, submitted in such manner, and
p.000311: contain such informa- tion, as the Secretary shall by regulation prescribe.
p.000311: (c) The Secretary shall assign Corps members to entities in health professional shortage areas without
p.000311: regard to the ability of the individuals in such areas, population groups, medical facilities, or other public
p.000311: facilities to pay for such services.
p.000311: (d)(1) The Secretary may provide technical assistance to a pub- lic or private entity which is located in a health
p.000311: professional short- age area and which desires to make an application under this sec- tion for assignment of a
p.000311: Corps member to such area. Assistance provided under this paragraph may include assistance to an entity in (A)
p.000311: analyzing the potential use of health professions personnel in defined health services delivery areas by
p.000311: the residents of such areas, (B) determining the need for such personnel in such areas,
p.000311: (C) determining the extent to which such areas will have a finan- cial base to support the practice of
p.000311: such personnel and the extent to which additional financial resources are needed to adequately support
p.000311: the practice, (D) determining the types of inpatient and other health services that should be provided by such
p.000311: personnel in such areas, and (E) developing long-term plans for addressing health professional shortages and
p.000311: improving access to health care. The Secretary shall encourage entities that receive technical assist- ance under
p.000311: this paragraph to communicate with other commu- nities, State Offices of Rural Health, State Primary
p.000311: Care Associa- tions and Offices, and other entities concerned with site develop- ment and community needs
p.000311: assessment.
p.000311: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000311:
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p.000311: Sec. 333 PUBLIC HEALTH SERVICE ACT 312
p.000311:
p.000311: (2) The Secretary may provide, to public and private entities which are located in a health professional
p.000311: shortage area to which area a Corps member has been assigned, technical assistance to as- sist in the retention of
p.000311: such member in such area after the comple- tion of such member’s assignment to the area.
p.000311: (3) The Secretary may provide, to health professional shortage areas to which no Corps member has been
p.000311: assigned, (A) technical assistance to assist in the recruitment of health manpower for such areas, and (B) current
p.000311: information on public and private programs which provide assistance in the securing of health manpower.
p.000311: (4)(A) The Secretary shall undertake to demonstrate the im- provements that can be made in the assignment of
p.000311: members of the Corps to health professional shortage areas and in the delivery of health care by Corps
...

p.000347: (B) LICENSURE OF HEALTH PROFESSIONALS.—Nothing in this section shall be construed to supersede State
p.000347: law regarding licensure of health professionals.
p.000347: (d) DESIGNATIONS.—The demonstration project described in this section, and any providers who are
p.000347: selected to participate in such project, shall not be considered by the Secretary in the des- ignation
p.000347: of a health professional shortage area under section 332 during fiscal years 2002 through 2004.
p.000347: (e) RULE OF CONSTRUCTION.—This section shall not be con- strued to require any State to participate in
p.000347: the project described in this section.
p.000347: (f) REPORT.—
p.000347: (1) IN GENERAL.—The Secretary shall evaluate the partici- pation of individuals in the demonstration projects
p.000347: under this section and prepare and submit a report containing the infor- mation described in paragraph (2)
p.000347: to—
p.000347: (A) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.000347: (B) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria-
p.000347: tions of the Senate;
p.000347: (C) the Committee on Energy and Commerce of the House of Representatives; and
p.000347: (D) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria-
p.000347: tions of the House of Representatives.
p.000347: (2) CONTENT.—The report described in paragraph (1) shall detail—
p.000347: (A) the manner in which the demonstration project de- scribed in this section has affected access to primary
p.000347: care services, patient satisfaction, quality of care, and health care services provided for traditionally
p.000347: underserved popu- lations;
p.000347: (B) how the participation of chiropractic doctors and pharmacists in the Loan Repayment Program might affect the
p.000347: designation of health professional shortage areas; and
p.000347: (C) whether adding chiropractic doctors and phar- macists as permanent members of the National
p.000347: Health Service Corps would be feasible and would enhance the ef- fectiveness of the National Health Service Corps.
p.000347: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000347: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section, such sums as may be
p.000347: necessary for fiscal years 2002 through 2004.
p.000347: (2) FISCAL YEAR 2005 44.—If the Secretary determines and certifies to Congress by not later than
p.000347: September 30, 2004,
p.000347:
p.000347:
p.000347:
p.000347:
p.000347: January 30, 2020
p.000347: 44 So in law. The figure in the heading for paragraph (2) was erroneously enacted so that ‘‘2005’’
p.000347: appears in full figures. However, the version represented here in the pdf reflects this
p.000347: Continued
p.000347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000347: Sec. 338M PUBLIC HEALTH SERVICE ACT 348
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p.000349: fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and
p.000349: September 30, 1987.
p.000349: (c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee
p.000349: on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
p.000349: (1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such
p.000349: subsections were in ef- fect prior to October 1, 1981);
p.000349: (2) the need to continue grants and loans under sub- sections (a) and (b) (as such subsections are in
p.000349: effect on the day after the date of enactment of the Orphan Drug Act); and
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000349:
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p.000351: 351
p.000351: PUBLIC HEALTH SERVICE ACT
p.000351: Sec. 340
p.000351:
p.000351: (3) the extent to which standards have been applied to the training of personnel who provide home health services.
p.000351: (d) For purposes of this section, the term ‘‘home health serv- ices’’ has the meaning prescribed for
p.000351: the term by section 1861(m) of the Social Security Act.
p.000351: Subpart V—Healthy Communities Access Program
p.000351:
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p.000351: January 30, 2020
p.000351: SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFI- CIENCY, AND COORDINATION OF SERVICES FOR THE
p.000351: UN- INSURED AND UNDERINSURED.
p.000351: (a) IN GENERAL.—The Secretary may award grants to eligible entities to assist in the development of integrated
p.000351: health care deliv- ery systems to serve communities of individuals who are uninsured and individuals who are
p.000351: underinsured—
p.000351: (1) to improve the efficiency of, and coordination among, the providers providing services through such
p.000351: systems;
p.000351: (2) to assist communities in developing programs targeted toward preventing and managing chronic diseases; and
p.000351: (3) to expand and enhance the services provided through such systems.
p.000351: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be an entity that—
p.000351: (1) represents a consortium—
p.000351: (A) whose principal purpose is to provide a broad range of coordinated health care services for a community
p.000351: defined in the entity’s grant application as described in paragraph (2); and
p.000351: (B) that includes at least one of each of the following providers that serve the community (unless such
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p.000353: health services; and
p.000353: (ii) direct patient care and service expansions to fill identified or documented gaps within an integrated
p.000353: delivery system.
p.000353: (B) SPECIFIC USES.—The following are examples of purposes for which a grantee may use grant funds under
p.000353: this section, when such use meets the conditions stated in subparagraph (A):
p.000353: (i) Increases in outreach activities and closing gaps in health care service.
p.000353: (ii) Improvements to case management.
p.000353: (iii) Improvements to coordination of transpor- tation to health care facilities.
p.000353: (iv) Development of provider networks and other innovative models to engage physicians in voluntary efforts
p.000353: to serve the medically underserved within a community.
p.000353: (v) Recruitment, training, and compensation of necessary personnel.
p.000353: (vi) Acquisition of technology for the purpose of co- ordinating care.
p.000353: (vii) Improvements to provider communication, in- cluding implementation of shared information systems or shared
p.000353: clinical systems.
p.000353: (viii) Development of common processes for deter- mining eligibility for the programs provided through the
p.000353: system, including creating common identification cards and single sliding scale discounts.
p.000353: (ix) Development of specific prevention and dis- ease management tools and processes.
p.000353: (x) Translation services.
p.000353: (xi) Carrying out other activities that may be ap- propriate to a community and that would increase ac- cess
p.000353: by the uninsured to health care, such as access initiatives for which private entities provide non-Fed-
p.000353: eral contributions to supplement the Federal funds provided through the grants for the initiatives.
p.000353: (2) DIRECT PATIENT CARE LIMITATION.—Not more than 15 percent of the funds provided under a grant awarded
p.000353: under
p.000353: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000355: 355
p.000355: PUBLIC HEALTH SERVICE ACT
p.000355: Sec. 340
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p.000355: January 30, 2020
p.000355: this section may be used for providing direct patient care and services.
p.000355: (3) RESERVATION OF FUNDS FOR NATIONAL PROGRAM PUR- POSES.—The Secretary may use not more than 3 percent
p.000355: of funds appropriated to carry out this section for providing tech- nical assistance to grantees, obtaining
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p.000355: (1) Acting as contacts, including by assisting in the coordi- nation of health care services and provider
p.000355: referrals, for indi- viduals who are seeking prevention or early detection services for, or who following a
p.000355: screening or early detection service are found to have a symptom, abnormal finding, or diagnosis of, cancer or
p.000355: other chronic disease.
p.000355: (2) Facilitating the involvement of community organiza- tions in assisting individuals who are at risk
p.000355: for or who have
p.000355: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000357: PUBLIC HEALTH SERVICE ACT
p.000357: Sec. 340A
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p.000357: cancer or other chronic diseases to receive better access to high-quality health care services (such as by
p.000357: creating partner- ships with patient advocacy groups, charities, health care cen- ters, community hospice centers,
p.000357: other health care providers, or other organizations in the targeted community).
p.000357: (3) Notifying individuals of clinical trials and, on request, facilitating enrollment of eligible individuals
p.000357: in these trials.
p.000357: (4) Anticipating, identifying, and helping patients to over- come barriers within the health care system to
p.000357: ensure prompt diagnostic and treatment resolution of an abnormal finding of cancer or other chronic disease.
p.000357: (5) Coordinating with the relevant health insurance om- budsman programs to provide information to
p.000357: individuals who are at risk for or who have cancer or other chronic diseases about health coverage,
p.000357: including private insurance, health care savings accounts, and other publicly funded programs (such as Medicare,
p.000357: Medicaid, health programs operated by the Depart- ment of Veterans Affairs or the Department of Defense,
p.000357: the State children’s health insurance program, and any private or governmental prescription assistance
p.000357: programs).
p.000357: (6) Conducting ongoing outreach to health disparity popu- lations, including the uninsured, rural
p.000357: populations, and other medically underserved populations, in addition to assisting other individuals who are
p.000357: at risk for or who have cancer or other chronic diseases to seek preventative care.
p.000357: (c) PROHIBITIONS.—
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p.000357:
p.000357: (3) MINIMUM CORE PROFICIENCIES.—The Secretary shall not award a grant to an entity under this section
p.000357: unless such entity provides assurances that patient navigators recruited, assigned, trained, or employed
p.000357: using grant funds meet min- imum core proficiencies, as defined by the entity that submits the
p.000357: application, that are tailored for the main focus or inter- vention of the navigator involved.
p.000357: (f) UNIFORM BASELINE MEASURES.—The Secretary shall estab- lish uniform baseline measures in order to
p.000357: properly evaluate the impact of the demonstration projects under this section.
p.000357: (g) PREFERENCE.—In making grants under this section, the Secretary shall give preference to eligible entities
p.000357: that demonstrate in their applications plans to utilize patient navigator services to overcome significant
p.000357: barriers in order to improve health care out- comes in their respective communities.
p.000357: (h) DUPLICATION OF SERVICES.—An eligible entity that is re- ceiving Federal funds for activities described
p.000357: in subsection (b) on the date on which the entity submits an application under sub- section (e) may
p.000357: not receive a grant under this section unless the entity can demonstrate that amounts received under the grant
p.000357: will be utilized to expand services or provide new services to individuals who would not otherwise be served.
p.000357: (i) COORDINATION WITH OTHER PROGRAMS.—The Secretary shall ensure coordination of the
p.000357: demonstration grant program under this section with existing authorized programs in order to fa- cilitate access to
p.000357: high-quality health care services.
p.000357: (j) STUDY; REPORTS.—
p.000357: (1) FINAL REPORT BY SECRETARY.—Not later than 6 months after the completion of the demonstration grant program under
p.000357: this section, the Secretary shall conduct a study of the results of the program and submit to the Congress a
p.000357: report on such results that includes the following:
p.000357: (A) An evaluation of the program outcomes, includ- ing—
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p.000357: (i) quantitative analysis of baseline and bench- mark measures; and
p.000357: (ii) aggregate information about the patients served and program activities.
p.000357: (B) Recommendations on whether patient navigator programs could be used to improve patient outcomes in
p.000357: other public health areas.
p.000357: (2) INTERIM REPORTS BY SECRETARY.—The Secretary may provide interim reports to the Congress on the
p.000357: demonstration grant program under this section at such intervals as the Sec- retary determines to be appropriate.
p.000357: (3) REPORTS BY GRANTEES.—The Secretary may require grant recipients under this section to submit interim and
p.000357: final reports on grant program outcomes.
p.000357: (k) RULE OF CONSTRUCTION.—This section shall not be con- strued to authorize funding for the delivery of health
p.000357: care services (other than the patient navigator duties listed in subsection (b)).
p.000357: (l) DEFINITIONS.—In this section:
p.000357: (1) The term ‘‘eligible entity’’ means a public or nonprofit private health center (including a Federally
p.000357: qualified health
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p.000361: which is formally granted governmental powers by a unit of State or local government, or is a private non-profit
p.000361: hospital which has a contract with a State or local government to provide health care services to low
p.000361: income individuals who are not entitled to benefits under title XVIII of the Social Security Act or eligible for
p.000361: assistance under the State plan under this title;
p.000361: (ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a dis-
p.000361: proportionate share adjustment percentage (as deter- mined under section 1886(d)(5)(F) of the Social Secu-
p.000361: rity Act) greater than 11.75 percent or was described in section 1886(d)(5)(F)(i)(II) of such Act; and
p.000361: (iii) does not obtain covered outpatient drugs through a group purchasing organization or other
p.000361: group purchasing arrangement.
p.000361: (M) A children’s hospital excluded from the Medicare prospective payment system pursuant to
p.000361: section 1886(d)(1)(B)(iii) of the Social Security Act, or a free-stand- ing cancer hospital excluded from the Medicare
p.000361: prospective payment system pursuant to section 1886(d)(1)(B)(v) of the Social Security Act, that would meet the
p.000361: requirements of subparagraph (L), including the disproportionate share ad- justment percentage requirement under
p.000361: clause (ii) of such subparagraph, if the hospital were a subsection (d) hos- pital as defined by section
p.000361: 1886(d)(1)(B) of the Social Secu- rity Act.
p.000361: (N) An entity that is a critical access hospital (as de- termined under section 1820(c)(2) of the
p.000361: Social Security Act), and that meets the requirements of subparagraph (L)(i).
p.000361: (O) An entity that is a rural referral center, as defined by section 1886(d)(5)(C)(i) of the Social Security
p.000361: Act, or a sole community hospital, as defined by section 1886(d)(5)(C)(iii) of such Act,
p.000361: and that both meets the re- quirements of subparagraph (L)(i) and has a dispropor- tionate share
p.000361: adjustment percentage equal to or greater than 8 percent.
p.000361: (5) REQUIREMENTS FOR COVERED ENTITIES.—
p.000361: (A) PROHIBITING DUPLICATE DISCOUNTS OR REBATES.—
p.000361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000361:
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p.000361: Sec. 340B PUBLIC HEALTH SERVICE ACT 362
p.000361:
p.000361: (i) IN GENERAL.—A covered entity shall not re- quest payment under title XIX of the Social Security Act
p.000361: for medical assistance described in section 1905(a)(12) of such Act with respect to a drug
p.000361: that is subject to an agreement under this section if the drug is subject to the payment of a rebate to the
p.000361: State under section 1927 of such Act.
p.000361: (ii) ESTABLISHMENT OF MECHANISM.—The Sec- retary shall establish a mechanism to ensure that cov- ered
...

p.000363: section 2302(3) of Public Law 111–152 assumes that section 7102(a) of Public Law 111–148 exe- cuted properly and makes
p.000363: amendments to subsection (d).
p.000363: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000365: PUBLIC HEALTH SERVICE ACT
p.000365: Sec. 340B
p.000365:
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p.000365: January 30, 2020
p.000365: how the refunds will be calculated, and to whom the refunds will be issued.
p.000365: (II) Oversight by the Secretary to ensure that the refunds are issued accurately and within a reasonable
p.000365: period of time, both in routine in- stances of retroactive adjustment to relevant pric- ing data and
p.000365: exceptional circumstances such as erroneous or intentional overcharging for covered outpatient drugs.
p.000365: (iii) The provision of access through the Internet website of the Department of Health and Human
p.000365: Services to the applicable ceiling prices for covered outpatient drugs as calculated and verified by the Sec-
p.000365: retary in accordance with this section, in a manner (such as through the use of password protection)
p.000365: that limits such access to covered entities and adequately assures security and protection of privileged
p.000365: pricing data from unauthorized re-disclosure.
p.000365: (iv) The development of a mechanism by which—
p.000365: (I) rebates and other discounts provided by manufacturers to other purchasers subsequent to the sale of
p.000365: covered outpatient drugs to covered en- tities are reported to the Secretary; and
p.000365: (II) appropriate credits and refunds are issued to covered entities if such discounts or rebates have the
p.000365: effect of lowering the applicable ceiling price for the relevant quarter for the drugs in- volved.
p.000365: (v) Selective auditing of manufacturers and whole- salers to ensure the integrity of the drug discount pro- gram under
p.000365: this section.
p.000365: (vi) The imposition of sanctions in the form of civil monetary penalties, which—
p.000365: (I) shall be assessed according to standards established in regulations to be promulgated by the Secretary
p.000365: not later than 180 days after the date of enactment of the Patient Protection and Affordable Care Act;
p.000365: (II) shall not exceed $5,000 for each instance of overcharging a covered entity that may have oc- curred; and
p.000365: (III) shall apply to any manufacturer with an agreement under this section that knowingly and intentionally
p.000365: charges a covered entity a price for purchase of a drug that exceeds the maximum ap- plicable price under
p.000365: subsection (a)(1).
p.000365: (2) COVERED ENTITY COMPLIANCE.—
...

p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
p.000377: (2) ASSURANCES.—The application shall include assurances that the State will meet the requirements of subsection (d)
p.000377: and that the State possesses sufficient infrastructure to manage the activities to be funded through the
p.000377: grant and to evaluate and report on the outcomes resulting from such activities.
p.000377: (d) MATCHING REQUIREMENT.—The Secretary may not make a grant to a State under this section unless that
p.000377: State agrees that, with respect to the costs to be incurred by the State in carrying out the activities for which the
p.000377: grant was awarded, the State will pro- vide non-Federal contributions in an amount equal to not less than 40 percent
p.000377: of Federal funds provided under the grant. The State
p.000377: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000379: 379
p.000379: PUBLIC HEALTH SERVICE ACT
p.000379: Sec. 340G–1
p.000379:
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p.000379: January 30, 2020
p.000379: may provide the contributions in cash or in kind, fairly evaluated, including plant, equipment, and services and may
p.000379: provide the con- tributions from State, local, or private sources.
p.000379: (e) REPORT.—Not later than 5 years after the date of enact- ment of the Health Care Safety Net Amendments of
p.000379: 2002, the Sec- retary shall prepare and submit to the appropriate committees of Congress a report
p.000379: containing data relating to whether grants pro- vided under this section have increased access to dental services
p.000379: in designated dental health professional shortage areas.
p.000379: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000379: $13,903,000 for each of fiscal years 2019 through 2023.
p.000379: SEC. 340G–1. ø256g–1¿ DEMONSTRATION PROGRAM.
p.000379: (a) IN GENERAL.—
p.000379: (1) AUTHORIZATION.—The Secretary is authorized to award grants to 15 eligible entities to enable such entities to
p.000379: establish a demonstration program to establish training programs to train, or to employ, alternative dental
p.000379: health care providers in order to increase access to dental health care services in rural and other underserved
p.000379: communities.
p.000379: (2) DEFINITION.—The term ‘‘alternative dental health care providers’’ includes community dental health
p.000379: coordinators, ad- vance practice dental hygienists, independent dental hygien- ists, supervised dental
p.000379: hygienists, primary care physicians, dental therapists, dental health aides, and any other health
p.000379: professional that the Secretary determines appropriate.
p.000379: (b) TIMEFRAME.—The demonstration projects funded under this section shall begin not later than 2 years after
p.000379: the date of enact- ment of this section, and shall conclude not later than 7 years after such date of enactment.
p.000379: (c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under subsection (a), an entity shall—
p.000379: (1) be—
p.000379: (A) an institution of higher education, including a com- munity college;
p.000379: (B) a public-private partnership;
p.000379: (C) a federally qualified health center;
p.000379: (D) an Indian Health Service facility or a tribe or trib- al organization (as such terms are defined in section
p.000379: 4 of the Indian Self-Determination and Education Assistance Act);
p.000379: (E) a State or county public health clinic, a health fa- cility operated by an Indian tribe or tribal organization, or
p.000379: urban Indian organization providing dental services; or
p.000379: (F) a public hospital or health system;
p.000379: (2) be within a program accredited by the Commission on Dental Accreditation or within a dental
p.000379: education program in an accredited institution; and
...

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p.000379: Sec. 340H PUBLIC HEALTH SERVICE ACT 380
p.000379:
p.000379: (1) AMOUNT OF GRANT.—Each grant under this section shall be in an amount that is not less than $4,000,000 for
p.000379: the 5-year period during which the demonstration project being conducted.
p.000379: (2) DISBURSEMENT OF FUNDS.—
p.000379: (A) PRELIMINARY DISBURSEMENTS.—Beginning 1 year after the enactment of this section, the Secretary may dis- perse
p.000379: to any entity receiving a grant under this section not more than 20 percent of the total funding awarded to such entity
p.000379: under such grant, for the purpose of enabling the entity to plan the demonstration project to be
p.000379: conducted under such grant.
p.000379: (B) SUBSEQUENT DISBURSEMENTS.—The remaining amount of grant funds not dispersed under subparagraph
p.000379: (A) shall be dispersed such that not less than 15 percent of such remaining amount is dispersed each
p.000379: subsequent year.
p.000379: (e) COMPLIANCE WITH STATE REQUIREMENTS.—Each entity re- ceiving a grant under this section shall certify that it
p.000379: is in compli- ance with all applicable State licensing requirements.
p.000379: (f) EVALUATION.—The Secretary shall contract with the Direc- tor of the Institute of Medicine to conduct
p.000379: a study of the dem- onstration programs conducted under this section that shall pro- vide analysis, based
p.000379: upon quantitative and qualitative data, re- garding access to dental health care in the United States.
p.000379: (g) CLARIFICATION REGARDING DENTAL HEALTH AIDE PRO- GRAM.—Nothing in this section shall prohibit
p.000379: a dental health aide training program approved by the Indian Health Service from being eligible for a grant
p.000379: under this section.
p.000379: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000379: carry out this section.
p.000379:
p.000379: Subpart XI—Support of Graduate Medical Education in Qualified Teaching Health Centers
p.000379:
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p.000379:
p.000379: January 30, 2020
p.000379: SEC. 340H. ø256h¿ PROGRAM OF PAYMENTS TO TEACHING HEALTH CENTERS THAT OPERATE GRADUATE MEDICAL EDU-
p.000379: CATION PROGRAMS.
p.000379: (a) PAYMENTS.—
p.000379: (1) IN GENERAL.—Subject to subsection (h)(2), the Sec- retary shall make payments under this section for
p.000379: direct ex- penses and indirect expenses to qualified teaching health cen- ters that are listed as
p.000379: sponsoring institutions by the relevant accrediting body for, as appropriate—
p.000379: (A) maintenance of filled positions at existing ap- proved graduate medical residency training programs;
p.000379: (B) expansion of existing approved graduate medical residency training programs; and
p.000379: (C) establishment of new approved graduate medical residency training programs.
p.000379: (2) PER RESIDENT AMOUNT.—In making payments under paragraph (1), the Secretary shall consider the cost of
...

p.000385: (as defined by the Secretary) for low-income popu- lations.
p.000385: (2) REQUIRED INCLUSION.—A network shall include the fol- lowing providers (unless such provider does not exist
p.000385: within the community, declines or refuses to participate, or places un- reasonable conditions on their participation):
p.000385: (A) A hospital that meets the criteria in section 1923(b)(1) of the Social Security Act; and
p.000385: (B) All Federally qualified health centers (as defined in section 1861(aa) of the Social Security Act located in
p.000385: the community.
p.000385: (3) PRIORITY.—In awarding grants, the Secretary shall give priority to networks that include—
p.000385: (A) the capability to provide the broadest range of services to low-income individuals;
p.000385: (B) the broadest range of providers that currently serve a high volume of low-income individuals; and
p.000385: (C) a county or municipal department of health.
p.000385: (c) APPLICATION.—
p.000385: (1) APPLICATION.—A network described in subsection (b) shall submit an application to the Secretary.
p.000385: (2) RENEWAL.—In subsequent years, based on the perform- ance of grantees, the Secretary may provide renewal grants to
p.000385: prior year grant recipients.
p.000385: (d) USE OF FUNDS.—
p.000385: (1) USE BY GRANTEES.—Grant funds may be used for the following activities:
p.000385: (A) Assist low-income individuals to—
p.000385: (i) access and appropriately use health services;
p.000385: (ii) enroll in health coverage programs; and
p.000385: (iii) obtain a regular primary care provider or a medical home.
p.000385: (B) Provide case management and care management.
p.000385: (C) Perform health outreach using neighborhood health workers or through other means.
p.000385: (D) Provide transportation.
p.000385: (E) Expand capacity, including through telehealth, after-hours services or urgent care.
p.000385: (F) Provide direct patient care services.
p.000385: (2) GRANT FUNDS TO HRSA GRANTEES.—The Secretary may limit the percent of grant funding that may be spent on direct
p.000385: care services provided by grantees of programs administered by the Health Resources and Services
p.000385: Administration or im- pose other requirements on such grantees deemed necessary.
p.000385:
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p.000385: January 30, 2020
p.000385: and section 340I, respectively. Such amendment probably should have included a reference to title III in
p.000385: the amendment instruction; however, such amendments were carried out to reflect the probable intent of
p.000385: Congress.
p.000385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000385:
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p.000387: PUBLIC HEALTH SERVICE ACT
p.000387: Sec. 351
p.000387:
p.000387: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
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p.000393: under subparagraph (A) shall not preclude the review of, or ac- tion on, an application submitted under this
p.000393: subsection.
p.000393: (D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUID- ANCE.—If the Secretary issues product class-specific guid-
p.000393: ance under subparagraph (A), such guidance shall include a description of—
p.000393: (i) the criteria that the Secretary will use to deter- mine whether a biological product is highly similar to a
p.000393: reference product in such product class; and
p.000393: (ii) the criteria, if available, that the Secretary will use to determine whether a biological product
p.000393: meets the standards described in paragraph (4).
p.000393: (E) CERTAIN PRODUCT CLASSES.—
p.000393: (i) GUIDANCE.—The Secretary may indicate in a guidance document that the science and experience, as of the date
p.000393: of such guidance, with respect to a product or product class (not including any recombinant pro- tein) does not
p.000393: allow approval of an application for a li- cense as provided under this subsection for such prod- uct or product class.
p.000393: (ii) MODIFICATION OR REVERSAL.—The Secretary may issue a subsequent guidance document under
p.000393: subparagraph (A) to modify or reverse a guidance doc- ument under clause (i).
p.000393: (iii) NO EFFECT ON ABILITY TO DENY LICENSE.— Clause (i) shall not be construed to require the
p.000393: Sec- retary to approve a product with respect to which the Secretary has not indicated in a guidance document
p.000393: that the science and experience, as described in clause (i), does not allow approval of such an application.
p.000393: (l) PATENTS.—
p.000393: (1) CONFIDENTIAL ACCESS TO SUBSECTION (k) APPLICA- TION.—
p.000393:
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p.000393: January 30, 2020
p.000393: (A) APPLICATION OF PARAGRAPH.—Unless otherwise agreed to by a person that submits an application
p.000393: under subsection (k) (referred to in this subsection as the ‘‘sub- section (k) applicant’’) and the
p.000393: sponsor of the application for the reference product (referred to in this subsection as the ‘‘reference product
p.000393: sponsor’’), the provisions of this paragraph shall apply to the exchange of information de- scribed in this
p.000393: subsection.
p.000393: (B) IN GENERAL.—
p.000393: (i) PROVISION OF CONFIDENTIAL INFORMATION.— When a subsection (k) applicant submits an applica- tion
p.000393: under subsection (k), such applicant shall provide to the persons described in clause (ii), subject to the
p.000393: terms of this paragraph, confidential access to the in- formation required to be produced pursuant to
p.000393: para- graph (2) and any other information that the sub- section (k) applicant determines, in its sole
p.000393: discretion, to be appropriate (referred to in this subsection as the ‘‘confidential information’’).
p.000393: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000393:
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p.000395: PUBLIC HEALTH SERVICE ACT
p.000395: Sec. 351
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p.000395: January 30, 2020
p.000395: (ii) RECIPIENTS OF INFORMATION.—The persons de- scribed in this clause are the following:
p.000395: (I) OUTSIDE COUNSEL.—One or more attorneys designated by the reference product sponsor who are employees of an
p.000395: entity other than the ref- erence product sponsor (referred to in this para- graph as the ‘‘outside
p.000395: counsel’’), provided that such attorneys do not engage, formally or infor- mally, in patent prosecution
p.000395: relevant or related to the reference product.
p.000395: (II) IN-HOUSE COUNSEL.—One attorney that represents the reference product sponsor who is an employee of the
p.000395: reference product sponsor, pro- vided that such attorney does not engage, formally or informally, in patent prosecution
p.000395: relevant or re- lated to the reference product.
p.000395: (iii) PATENT OWNER ACCESS.—A representative of the owner of a patent exclusively licensed to a ref-
p.000395: erence product sponsor with respect to the reference product and who has retained a right to assert the
p.000395: patent or participate in litigation concerning the pat- ent may be provided the confidential information, pro-
p.000395: vided that the representative informs the reference product sponsor and the subsection (k) applicant of his or
p.000395: her agreement to be subject to the confidentiality provisions set forth in this paragraph, including those under
p.000395: clause (ii).
p.000395: (C) LIMITATION ON DISCLOSURE.—No person that re- ceives confidential information pursuant to subparagraph
p.000395: (B) shall disclose any confidential information to any other person or entity, including the reference product
p.000395: sponsor employees, outside scientific consultants, or other outside counsel retained by the reference product
p.000395: sponsor, without the prior written consent of the subsection (k) applicant, which shall not be unreasonably
p.000395: withheld.
p.000395: (D) USE OF CONFIDENTIAL INFORMATION.—Confidential information shall be used for the sole and exclusive pur-
p.000395: pose of determining, with respect to each patent assigned to or exclusively licensed by the reference product
p.000395: sponsor, whether a claim of patent infringement could reasonably be asserted if the subsection (k)
p.000395: applicant engaged in the manufacture, use, offering for sale, sale, or importation into the United States of
p.000395: the biological product that is the subject of the application under subsection (k).
...

p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
p.000401: Subtitle C of such title (section 221 et seq.; 116 Stat. 657) relates to interagency coordination of the two
p.000401: programs.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000403: PUBLIC HEALTH SERVICE ACT
p.000403: Sec. 351A
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p.000403: (B) proper laboratory facilities to contain and dispose of such agents and toxins;
p.000403: (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and
p.000403: toxins for use in domestic or international terrorism or for any other criminal purpose;
p.000403: (3) the establishment of procedures to protect the public safety in the event of a transfer or
p.000403: potential transfer of such an agent or toxin in violation of the safety procedures estab- lished under
p.000403: paragraph (1) or the safeguard and security meas- ures established under paragraph (2); and
p.000403: (4) appropriate availability of biological agents and toxins for research, education, and other legitimate
p.000403: purposes.
p.000403: (c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—The Secretary shall by regulation provide for the
p.000403: establishment and en- forcement of standards and procedures governing the possession and use of listed
p.000403: agents and toxins, including the provisions de- scribed in paragraphs (1) through (4) of subsection (b),
p.000403: in order to protect the public health and safety.
p.000403: (d) REGISTRATION; IDENTIFICATION; DATABASE.—
p.000403: (1) REGISTRATION.—Regulations under subsections (b) and
p.000403: (c) shall require registration with the Secretary of the posses- sion, use, and transfer of listed agents and
p.000403: toxins, and shall in- clude provisions to ensure that persons seeking to register under such regulations
p.000403: have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in ac-
p.000403: cordance with subsection (e)(6).
p.000403: (2) IDENTIFICATION; DATABASE.—Regulations under sub- sections (b) and (c) shall require that
p.000403: registration include (if available to the person registering) information regarding the characterization of
p.000403: listed agents and toxins to facilitate their identification, including their source. The Secretary shall main-
p.000403: tain a national database that includes the names and locations of registered persons, the listed agents and toxins such
p.000403: persons are possessing, using, or transferring, and information regard- ing the characterization of such agents and
p.000403: toxins.
p.000403: (e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED PERSONS.—
p.000403: (1) IN GENERAL.—Regulations under subsections (b) and (c) shall include appropriate safeguard and security requirements
p.000403: for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin
p.000403: poses to public health and safety (including the risk of use in domestic or international terrorism). The Secretary
p.000403: shall establish such requirements in collaboration with the Secretary of Homeland Security and the
p.000403: Attorney General, and shall ensure compli- ance with such requirements as part of the registration system under
p.000403: such regulations.
p.000403: (2) LIMITING ACCESS TO LISTED AGENTS AND TOXINS.—Re- quirements under paragraph (1) shall include provisions to
p.000403: en- sure that registered persons—
p.000403: (A) provide access to listed agents and toxins to only those individuals whom the registered person involved
p.000403: de-
p.000403: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000403: Sec. 351A PUBLIC HEALTH SERVICE ACT 404
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p.000403: termines have a legitimate need to handle or use such agents and toxins;
p.000403: (B) submit the names and other identifying informa- tion for such individuals to the Secretary and the Attorney
p.000403: General, promptly after first determining that the individ- uals need access under subparagraph (A), and periodically
p.000403: thereafter while the individuals have such access, not less frequently than once every five years;
p.000403: (C) deny access to such agents and toxins by individ- uals whom the Attorney General has identified as
p.000403: re- stricted persons; and
p.000403: (D) limit or deny access to such agents and toxins by individuals whom the Attorney General has
p.000403: identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the
p.000403: individuals involved is deter- mined appropriate by the Secretary, in consultation with the Attorney General.
p.000403: (3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.—
p.000403: (A) IN GENERAL.—Upon the receipt of names and other identifying information under paragraph (2)(B), the Attor-
p.000403: ney General shall, for the sole purpose of identifying whether the individuals involved are within any
p.000403: of the cat- egories specified in subparagraph (B), promptly use crimi- nal, immigration, national security, and
p.000403: other electronic databases that are available to the Federal Government and are appropriate for such purpose.
p.000403: (B) CERTAIN INDIVIDUALS.—For purposes of subpara- graph (A), the categories specified in this subparagraph re-
p.000403: garding an individual are that—
p.000403: (i) the individual is a restricted person; or
p.000403: (ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
p.000403: (I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;
p.000403: (II) knowing involvement with an organiza- tion that engages in domestic or international ter- rorism (as defined
p.000403: in section 2331 of such title 18) or with any other organization that engages in in- tentional crimes of violence; or
p.000403: (III) being an agent of a foreign power (as de- fined in section 1801 of title 50, United States Code).
p.000403: (C) NOTIFICATION BY ATTORNEY GENERAL REGARDING SUBMITTED NAMES.—After the receipt of a name and other
p.000403: identifying information under paragraph (2)(B), the Attor- ney General shall promptly notify the Secretary
p.000403: whether the individual is within any of the categories specified in subparagraph (B).
p.000403: (4) NOTIFICATIONS BY SECRETARY.—The Secretary, after re- ceiving notice under paragraph (3) regarding an
p.000403: individual, shall promptly notify the registered person involved of whether the individual is granted or denied access
p.000403: under paragraph (2).
p.000403: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000405: PUBLIC HEALTH SERVICE ACT
p.000405: Sec. 351A
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p.000405: If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.
p.000405: (5) EXPEDITED REVIEW.—Regulations under subsections (b) and (c) shall provide for a procedure through which,
p.000405: upon re- quest to the Secretary by a registered person who submits names and other identifying
p.000405: information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by
p.000405: the Secretary—
p.000405: (A) request the Attorney General to expedite the proc- ess of identification under paragraph (3)(A) and
p.000405: notifica- tion of the Secretary under paragraph (3)(C); and
p.000405: (B) expedite the notification of the registered person by the Secretary under paragraph (4).
p.000405: (6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
p.000405: (A) INDIVIDUALS.—Regulations under subsections (b) and (c) shall provide that an individual who seeks to
p.000405: reg- ister under either of such subsections is subject to the same processes described in paragraphs (2)
p.000405: through (4) as apply to names and other identifying information sub- mitted to the Attorney General under
p.000405: paragraph (2)(B). Paragraph (5) does not apply for purposes of this subpara- graph.
p.000405: (B) OTHER PERSONS.—Regulations under subsections
p.000405: (b) and (c) shall provide that, in determining whether to deny or revoke registration by a person other than
p.000405: an indi- vidual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal,
p.000405: immigra- tion, national security, and other electronic databases available to the Federal Government,
p.000405: as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the
p.000405: individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law
p.000405: enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied
p.000405: to persons, including individuals). Such regulations shall provide that a person who seeks to register under
p.000405: either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply
p.000405: to names and other identifying information sub- mitted to the Attorney General under paragraph (2)(B).
p.000405: Paragraph (5) does not apply for purposes of this subpara- graph. The Secretary may exempt Federal, State, or
p.000405: local governmental agencies from the requirements of this sub- paragraph.
p.000405: (7) REVIEW.—
p.000405: (A) ADMINISTRATIVE REVIEW.—
p.000405: (i) IN GENERAL.—Regulations under subsections
p.000405: (b) and (c) shall provide for an opportunity for a re- view by the Secretary—
p.000405: (I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual
p.000405: access to listed agents and toxins; and
p.000405: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000405: (II) when requested by the person involved, of a determination under paragraph (6) to deny or revoke
p.000405: registration for such person.
p.000405: (ii) EX PARTE REVIEW.—During a review under clause (i), the Secretary may consider information rel- evant to the
p.000405: review ex parte to the extent that disclo- sure of the information could compromise national se- curity or an
p.000405: investigation by any law enforcement agency.
p.000405: (iii) FINAL AGENCY ACTION.—The decision of the Secretary in a review under clause (i) constitutes final agency
p.000405: action for purposes of section 702 of title 5, United States Code.
p.000405: (B) CERTAIN PROCEDURES.—
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p.000407: whole or in part, to provide for the timely participation of the person in a response to the agricultural
p.000407: emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not
p.000407: exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human
p.000407: Services may, after review of whether such exemption remains necessary, provide one extension of an additional
p.000407: 30 days.
p.000407: (h) DISCLOSURE OF INFORMATION.—
p.000407: (1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal agency specified in paragraph (2) shall disclose under
p.000407: section 552 of title 5, United States Code, any of the following:
p.000407: (A) Any registration or transfer documentation sub- mitted under subsections (b) and (c) for the
p.000407: possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that
p.000407: it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses
p.000407: the identity or location of a specific registered person.
p.000407: (B) The national database developed pursuant to sub- section (d), or any other compilation of the
p.000407: registration or transfer information submitted under subsections (b) and
p.000407: (c) to the extent that such compilation discloses site-spe- cific registration or transfer information.
p.000407: (C) Any portion of a record that discloses the site-spe- cific or transfer-specific safeguard and security
p.000407: measures used by a registered person to prevent unauthorized access to listed agents and toxins.
p.000407: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000409: PUBLIC HEALTH SERVICE ACT
p.000409: Sec. 351A
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p.000409: (D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c), or any
p.000409: noti- fication of theft or loss submitted under such subsections.
p.000409: (E) Any portion of an evaluation or report of an in- spection of a specific registered person conducted
p.000409: under subsection (f) that identifies the listed agent or toxin pos- sessed by a specific registered person or
p.000409: that discloses the identity or location of a specific registered person if the agency determines that
p.000409: public disclosure of the informa- tion would endanger public health or safety.
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p.000409: (D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving
p.000409: listed agents and toxins to or with a registered person, and to which information specified in paragraph (1)
p.000409: is transferred by any such registered person.
p.000409: (3) OTHER EXEMPTIONS.—This subsection may not be con- strued as altering the application of any
p.000409: exemptions to public disclosure under section 552 of title 5, United States Code, ex- cept as to subsection 552(b)(3)
p.000409: of such title, to any of the infor- mation specified in paragraph (1).
p.000409: (4) RULE OF CONSTRUCTION.—Except as specifically pro- vided in paragraph (1), this subsection may not be
p.000409: construed as altering the authority of any Federal agency to withhold under section 552 of title 5, United
p.000409: States Code, or the obliga- tion of any Federal agency to disclose under section 552 of title 5, United States Code,
p.000409: any information, including information relating to—
p.000409: (A) listed agents and toxins, or individuals seeking ac- cess to such agents and toxins;
p.000409: (B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and
p.000409: toxins;
p.000409: (C) general safeguard and security policies and re- quirements under regulations under subsections (b) and
p.000409: (c); or
p.000409: (D) summary or statistical information concerning reg- istrations, registrants, denials or revocations of
p.000409: registra- tions, listed agents and toxins, inspection evaluations and reports, or individuals seeking access
p.000409: to such agents and toxins.
p.000409: (5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This subsection may not be construed as providing any
p.000409: authority—
p.000409: (A) to withhold information from the Congress or any committee or subcommittee thereof; or
p.000409: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000409: Sec. 351A PUBLIC HEALTH SERVICE ACT 410
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p.000409: (B) to withhold information from any person under any other Federal law or treaty.
p.000409: (i) CIVIL MONEY PENALTY.— 61
p.000409: (1) IN GENERAL.—In addition to any other penalties that may apply under law, any person who violates
p.000409: any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money
p.000409: penalty in an amount not ex- ceeding $250,000 in the case of an individual and $500,000 in the case of
p.000409: any other person.
p.000409: (2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of section 1128A of the Social Security Act (other
p.000409: than sub- sections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of
p.000409: subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such
p.000409: provisions apply to a penalty or proceeding under sec- tion 1128A(a) of such Act. The Secretary may delegate author-
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p.000417: ogy specimens determined to be in the benign cat- egory, (II) focused rescreening of such preparations in high
p.000417: risk groups, and (III) for each abnormal cytological result, rescreening of all prior
p.000417: cytological specimens for the patient, if available,
p.000417: (iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or in-
p.000417: terpreting cytological preparations, including an- nounced and unannounced on-site 67 proficiency
p.000417: test- ing of such individuals, with such testing to take place, to the extent practicable, under normal working
p.000417: conditions,
p.000417: (v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is ren- dered on
p.000417: such slides, and for notifying referring physi- cians of such slides,
p.000417: (vi) requirements that all cytological screening be done on the premises of a laboratory that is
p.000417: certified under this section,
p.000417: (vii) requirements for the retention of cytology slides by laboratories for such periods of time as the
p.000417: Secretary considers appropriate, and
p.000417: (viii) standards requiring periodic inspection of cy- tology services by persons capable of evaluating the
p.000417: quality of cytology services.
p.000417: (g) INSPECTIONS.—
p.000417: (1) IN GENERAL.—The Secretary may, on an announced or unannounced basis, enter and inspect, during regular
p.000417: hours of operation, laboratories which have been issued a certificate under this section. In conducting
p.000417: such inspections the Sec- retary shall have access to all facilities, equipment, materials, records, and
p.000417: information that the Secretary determines have a bearing on whether the laboratory is being operated in accord-
p.000417:
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p.000417: 67 See footnote 1 for paragraph (3)(D).
p.000417:
p.000417: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000419: PUBLIC HEALTH SERVICE ACT
p.000419: Sec. 353
p.000419:
p.000419: ance with this section. As part of such an inspection the Sec- retary may copy any such material or
p.000419: require to it be 68 sub- mitted to the Secretary. An inspection under this paragraph may be made only upon
p.000419: presenting identification to the owner, operator, or agent in charge of the laboratory being inspected.
p.000419: (2) COMPLIANCE WITH REQUIREMENTS AND STANDARDS.— The Secretary shall conduct inspections of laboratories
p.000419: under paragraph (1) to determine their compliance with the require- ments of subsection (d) and the
p.000419: standards issued under sub- section (f). Inspections of laboratories not accredited under sub- section (e) shall be
p.000419: conducted on a biennial basis or with such other frequency as the Secretary determines to be necessary to assure
p.000419: compliance with such requirements and standards. In- spections of laboratories accredited under subsection
p.000419: (e) shall be conducted on such basis as the Secretary determines is nec- essary to assure compliance with such
p.000419: requirements and stand- ards.
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p.000425: Sec. 354 PUBLIC HEALTH SERVICE ACT 426
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p.000425: January 30, 2020
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p.000425: (4) PROVISIONAL CERTIFICATE.—The Secretary may issue a provisional certificate for an entity to enable the entity to
p.000425: qual- ify as a facility. The applicant for a provisional certificate shall meet the requirements of subsection (d)(1),
p.000425: except providing in- formation required by clauses (iii) and (iv) of subsection (d)(1)(A). A
p.000425: provisional certificate may be in effect no longer than 6 months from the date it is issued, except
p.000425: that it may be extended once for a period of not more than 90 days if the owner, lessor, or agent of the
p.000425: facility demonstrates to the Sec- retary that without such extension access to mammography in the geographic area
p.000425: served by the facility would be signifi- cantly reduced and if the owner, lessor, or agent of the facility will
p.000425: describe in a report to the Secretary steps that will be taken to qualify the facility for
p.000425: certification under subsection (b)(1).
p.000425: (d) APPLICATION FOR CERTIFICATE.—
p.000425: (1) SUBMISSION.—The Secretary may issue or renew a cer- tificate for a facility if—
p.000425: (A) the person who owns or leases the facility or an authorized agent of the person, submits to the
p.000425: Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum—
p.000425: (i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and proc-
p.000425: essor operated in the performance of mammography by the facility;
p.000425: (ii) a description of the procedures currently used to provide mammography at the facility, including—
p.000425: (I) the types of procedures performed and the number of such procedures performed in the prior 12 months;
p.000425: (II) the methodologies for mammography; and
p.000425: (III) the names and qualifications (educational background, training, and experience) of the per- sonnel
p.000425: performing mammography and the physi- cians reading and interpreting the results from the procedures;
p.000425: (iii) proof of on-site survey by a qualified medical physicist as described in subsection (f)(1)(E); and
p.000425: (iv) proof of accreditation in such manner as the Secretary shall prescribe; and
p.000425: (B) the person or agent submits to the Secretary—
p.000425: (i) a satisfactory assurance that the facility will be operated in accordance with standards established by the
...

p.000431: Subparagraph (G) shall not be construed to limit a patient’s ac- cess to the patient’s medical records.
p.000431: (2) CERTIFICATION OF PERSONNEL.—The Secretary shall by regulation—
p.000431: (A) specify organizations eligible to certify individuals to perform radiological procedures as required by
p.000431: para- graph (1)(C);
p.000431: (B) specify boards eligible to certify physicians to in- terpret radiological procedures, including
p.000431: mammography, as required by paragraph (1)(D);
p.000431: (C) establish standards for a program to certify physi- cians described in paragraph (1)(D); and
p.000431: (D) specify boards eligible to certify medical physicists who are qualified to survey mammography equipment and to
p.000431: oversee quality assurance practices at mammography facilities.
p.000431: (g) INSPECTIONS.—
p.000431: (1) ANNUAL INSPECTIONS.—
p.000431: (A) IN GENERAL.—The Secretary may enter and in- spect facilities to determine compliance with the
p.000431: certifi- cation requirements under subsection (b) and the stand- ards established under subsection (f). The
p.000431: Secretary shall, if feasible, delegate to a State or local agency the authority to make such inspections.
p.000431: (B) IDENTIFICATION.—The Secretary, or State or local agency acting on behalf of the Secretary, may
p.000431: conduct in- spections only on presenting identification to the owner, operator, or agent in charge of the
p.000431: facility to be inspected.
p.000431: (C) SCOPE OF INSPECTION.—In conducting inspections, the Secretary or State or local agency acting on
p.000431: behalf of the Secretary—
p.000431: (i) shall have access to all equipment, materials, records, and information that the Secretary or State or local
p.000431: agency considers necessary to determine whether the facility is being operated in accordance with this section;
p.000431: and
p.000431: (ii) may copy, or require the facility to submit to the Secretary or the State or local agency, any
p.000431: of the materials, records, or information.
p.000431: (D) QUALIFICATIONS OF INSPECTORS.—Qualified indi- viduals, as determined by the Secretary, shall conduct
p.000431: all inspections. The Secretary may request that a State or local agency acting on behalf of the
p.000431: Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal
p.000431: officer or employee to con- duct inspections. The Secretary shall establish minimum qualifications and
p.000431: appropriate training for inspectors and criteria for certification of inspectors in order to inspect fa- cilities
p.000431: for compliance with subsection (f).
p.000431: (E) FREQUENCY.—The Secretary or State or local agen- cy acting on behalf of the Secretary shall conduct
p.000431: inspec-
p.000431: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000431: Sec. 354 PUBLIC HEALTH SERVICE ACT 432
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p.000437: PUBLIC HEALTH SERVICE ACT
p.000437: Sec. 354
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p.000437: (A) advise the Secretary on appropriate quality stand- ards and regulations for mammography facilities;
p.000437: (B) advise the Secretary on appropriate standards and regulations for accreditation bodies;
p.000437: (C) advise the Secretary in the development of regula- tions with respect to sanctions;
p.000437: (D) assist in developing procedures for monitoring compliance with standards under subsection (f);
p.000437: (E) make recommendations and assist in the establish- ment of a mechanism to investigate consumer complaints;
p.000437: (F) report on new developments concerning breast im- aging that should be considered in the oversight of mam-
p.000437: mography facilities;
p.000437: (G) determine whether there exists a shortage of mammography facilities in rural and health
p.000437: professional shortage areas and determine the effects of personnel or other requirements of subsection (f)
p.000437: on access to the serv- ices of such facilities in such areas;
p.000437: (H) determine whether there will exist a sufficient number of medical physicists after October 1, 1999,
p.000437: to as- sure compliance with the requirements of subsection (f)(1)(E);
p.000437: (I) determine the costs and benefits of compliance with the requirements of this section (including the require-
p.000437: ments of regulations promulgated under this section); and
p.000437: (J) perform other activities that the Secretary may re- quire.
p.000437: The Advisory Committee shall report the findings made under subparagraphs (G) and (I) to the Secretary and the
p.000437: Congress no later than October 1, 1993.
p.000437: (4) MEETINGS.—The Advisory Committee shall meet not less than quarterly for the first 3 years of the
p.000437: program and thereafter, at least annually.
p.000437: (5) CHAIRPERSON.—The Secretary shall appoint a chair- person of the Advisory Committee.
p.000437: (o) CONSULTATIONS.—In carrying out this section, the Sec- retary shall consult with appropriate Federal
p.000437: agencies within the Department of Health and Human Services for the purposes of de- veloping standards,
p.000437: regulations, evaluations, and procedures for compliance and oversight.
p.000437: (p) BREAST CANCER SCREENING SURVEILLANCE RESEARCH GRANTS.—
p.000437: (1) RESEARCH.—
p.000437: (A) GRANTS.—The Secretary shall award grants to such entities as the Secretary may determine to be appro-
p.000437: priate to establish surveillance systems in selected geo- graphic areas to provide data to evaluate the
p.000437: functioning and effectiveness of breast cancer screening programs in the United States, including
p.000437: assessments of participation rates in screening mammography, diagnostic procedures, incidence of breast
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p.000437: Sec. 354 PUBLIC HEALTH SERVICE ACT 438
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p.000437: January 30, 2020
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p.000437: duction in breast cancer mortality. Grants may be awarded for further research on breast cancer surveillance systems
p.000437: upon the Secretary’s review of the evaluation of the pro- gram.
p.000437: (B) USE OF FUNDS.—Grants awarded under subpara- graph (A) may be used—
p.000437: (i) to study—
p.000437: (I) methods to link mammography and clinical breast examination records with population-based cancer registry data;
p.000437: (II) methods to provide diagnostic outcome data, or facilitate the communication of diagnostic outcome data,
p.000437: to radiology facilities for purposes of evaluating patterns of mammography interpre- tation; and
p.000437: (III) mechanisms for limiting access and maintaining confidentiality of all stored data; and
p.000437: (ii) to conduct pilot testing of the methods and mechanisms described in subclauses (I), (II), and (III)
p.000437: of clause (i) on a limited basis.
p.000437: (C) GRANT APPLICATION.—To be eligible to receive funds under this paragraph, an entity shall submit an ap-
p.000437: plication to the Secretary at such time, in such manner, and containing such information as the
p.000437: Secretary may re- quire.
p.000437: (D) REPORT.—A recipient of a grant under this para- graph shall submit a report to the Secretary containing the
p.000437: results of the study and testing conducted under clauses (i) and (ii) of subparagraph (B), along with
p.000437: recommendations for methods of establishing a breast cancer screening sur- veillance system.
p.000437: (2) ESTABLISHMENT.—The Secretary shall establish a breast cancer screening surveillance system based on
p.000437: the rec- ommendations contained in the report described in paragraph (1)(D).
p.000437: (3) STANDARDS AND PROCEDURES.—The Secretary shall es- tablish standards and procedures for the
p.000437: operation of the breast cancer screening surveillance system, including proce- dures to maintain
p.000437: confidentiality of patient records.
p.000437: (4) INFORMATION.—The Secretary shall recruit facilities to provide to the breast cancer screening surveillance
p.000437: system rel- evant data that could help in the research of the causes, char- acteristics, and prevalence of, and
p.000437: potential treatments for, breast cancer and benign breast conditions, if the information may be disclosed
p.000437: under section 552 of title 5, United States Code.
p.000437: (q) STATE PROGRAM.—
p.000437: (1) IN GENERAL.—The Secretary may, upon application, au- thorize a State—
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p.000449: and al- location,
p.000449: (K) work actively to increase the supply of donated organs,
p.000449: (L) submit to the Secretary an annual report containing in- formation on the comparative costs and patient
p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
p.000449:
p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
p.000449: (1) receiving from interested persons critical comments re- lating to the manner in which the Organ Procurement
p.000449: and Transplantation Network is carrying out the duties of the Net- work under subsection (b); and
p.000449: (2) the consideration by the Secretary of such critical com- ments.
p.000449: SCIENTIFIC REGISTRY
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p.000451: scribe.
p.000451: (b)(1) A grant for planning under section 371(a)(1) may be made for one year with respect to any organ
p.000451: procurement organiza- tion and may not exceed $100,000.
p.000451: (2) Grants under section 371(a)(2) may be made for two years. No such grant may exceed $500,000 for any year and no
p.000451: organ pro- curement organization may receive more than $800,000 for initial operation or expansion.
p.000451: (3) Grants or contracts under section 371(a)(3) may be made for not more than 3 years.
p.000451: (c)(1) The Secretary shall determine the amount of a grant or contract made under section 371 or 373.
p.000451: Payments under such grants and contracts may be made in advance on the basis of esti- mates or by the way of
p.000451: reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such install- ments and
p.000451: on such terms and conditions as the Secretary finds nec- essary to carry out the purposes of such grants and contracts.
p.000451: (2)(A) Each recipient of a grant or contract under section 371 or 373 shall keep such records as the
p.000451: Secretary shall prescribe, in- cluding records which fully disclose the amount and disposition by such recipient of
p.000451: the proceeds of such grant or contract, the total cost of the undertaking in connection with which such grant
p.000451: or con- tract was made, and the amount of that portion of the cost of the undertaking supplied by other
p.000451: sources, and such other records as will facilitate an effective audit.
p.000451: (B) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000451: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000451: records of the recipient of a grant or contract under section 371 or 373 that are pertinent to such
p.000451: grant or con- tract.
p.000451: (d) For purposes of this part:
p.000451: (1) The term ‘‘transplant center’’ means a health care facil- ity in which transplants of organs are performed.
p.000451: (2) The term ‘‘organ’’ means the human kidney, liver, heart, lung, pancreas, and any other human organ (other
p.000451: than corneas and eyes) specified by the Secretary by regulation and for purposes of section 373, such term
p.000451: includes bone marrow.
p.000451:
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p.000451: January 30, 2020
p.000451: ADMINISTRATION
p.000451: SEC. 375. ø274c¿ The Secretary shall designate and maintain an identifiable administrative unit in the
p.000451: Public Health Service to—
p.000451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000451: Sec. 376 PUBLIC HEALTH SERVICE ACT 452
p.000451:
p.000451: (1) administer this part and coordinate with the organ pro- curement activities under title XVIII of the Social
p.000451: Security Act,
p.000451: (2) conduct a program of public information to inform the public of the need for organ donations,
p.000451: (3) provide technical assistance to organ procurement orga- nizations, the Organ Procurement and Transplantation
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p.000459: entities for the accredi- tation of cord blood banks.
p.000459: (c) INFORMED CONSENT.—The Secretary shall, through a public process, examine issues of informed consent, including—
p.000459: (1) the appropriate timing of such consent; and
p.000459: (2) the information provided to the maternal donor regard- ing all of her medically appropriate cord blood options.
p.000459: Based on such examination, the Secretary shall require that the standards used by the accreditation entities
p.000459: recognized under sub- section (b) ensure that a cord blood unit is acquired with the in- formed consent of
p.000459: the maternal donor.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000459: Sec. 379 PUBLIC HEALTH SERVICE ACT 460
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p.000459: (d) FUNCTIONS.— 84
p.000459: (1) BONE MARROW FUNCTIONS.—With respect to bone mar- row, the Program shall—
p.000459: (A) operate a system for identifying, matching, and fa- cilitating the distribution of bone marrow that is
p.000459: suitably matched to candidate patients;
p.000459: (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care
p.000459: professionals, and patients to search by means of electronic access all available bone marrow donors listed in
p.000459: the Program;
p.000459: (C) carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including
p.000459: with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed
p.000459: ances- try) in the enrollment of the Program;
p.000459: (D) maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000459: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000461: subparagraph (A), collect, analyze, and publish data in a standardized electronic format on the number and
p.000461: percent- age of patients at each of the various stages of the search process, including data regarding the
p.000461: furthest stage reached, the number and percentage of patients who are unable to complete the search process,
p.000461: and the reasons un- derlying such circumstances;
p.000461: (J) support studies and demonstration and outreach projects for the purpose of increasing the number of
p.000461: indi- viduals who are willing to be marrow donors to ensure a genetically diverse donor pool; and
p.000461: (K) facilitate research with the appropriate Federal agencies to improve the availability, efficiency, safety,
p.000461: and cost of transplants from unrelated donors and the effec- tiveness of Program operations.
p.000461: (2) CORD BLOOD FUNCTIONS.—
p.000461: (A) IN GENERAL.—With respect to cord blood, the Pro- gram shall—
p.000461: (i) 85 operate a system for identifying, matching, and facilitating the distribution of donated cord
p.000461: blood units that are suitably matched to candidate patients and meet all applicable Federal and State
p.000461: regulations (including in- formed consent and Food and Drug Administration regula- tions) from a qualified cord blood
p.000461: bank;
p.000461: (ii) 85 consistent with paragraph (3), allow transplant physicians, other appropriate health care
p.000461: professionals, and patients to search by means of electronic access all available cord blood units made
p.000461: available through the Pro- gram;
p.000461: (iii) 85 allow transplant physicians and other appro- priate health care professionals to reserve, as
p.000461: defined by the Secretary, a cord blood unit for transplantation;
p.000461: (iv) support and expand new and existing studies and demonstration and outreach projects for the pur-
p.000461: pose of increasing cord blood unit donation and collec- tion from a genetically diverse population and expand- ing
p.000461: the number of cord blood unit collection sites partnering with cord blood banks receiving a
p.000461: contract under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and
p.000461: Re- search Act of 2005, including such studies and projects that focus on—
p.000461: (I) remote collection of cord blood units, con- sistent with the requirements under the Program and the
p.000461: National Cord Blood Inventory program
p.000461:
p.000461:
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p.000461:
p.000461: January 30, 2020
p.000461: 85 Margin so in law. The amendment by section 2(b)(2)(A)(ii) of Public Law 111–264 redesig- nates
p.000461: subpargraphs (A)–(H) as clauses (i)–(viii); however, the amendment did not move the mar- gins of such clauses to the
p.000461: right so that it appears indented 6 ems from the left margin (except for clause (iv) which was amended in its
p.000461: entirety by section 2(b)(2)(A)(iii) of such Public Law and as rewritten appears on the correct margin).
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000461: 86 Section 2(a)(2) of Public Law 114-104 amends subparagraph (B) by inserting ‘‘ including re- mote collection,’’ after
p.000461: ‘‘cord blood units,’’. Such amendment did not specify to which occurrence of the phrase ‘‘cord blood units,’’ to insert
p.000461: the new language.
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000463: 463
p.000463: PUBLIC HEALTH SERVICE ACT
p.000463: Sec. 379
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p.000463: the inventory goal. Each such plan shall be made available to the public.
p.000463: (C) DEFINITION.—In this paragraph, the term ‘‘remote collection’’ means the collection of cord blood units at
p.000463: loca- tions that do not have written contracts with cord blood banks for collection support.
p.000463: (3) SINGLE POINT OF ACCESS; STANDARD DATA.—
p.000463: (A) SINGLE POINT OF ACCESS.—The Secretary shall en- sure that health care professionals and patients are able
p.000463: to search electronically for and facilitate access to, in the manner and to the extent defined by the
p.000463: Secretary and consistent with the functions described in paragraphs (1)(A) and (2)(A)(i), cells from
p.000463: bone marrow donors and cord blood units through a single point of access.
p.000463: (B) STANDARD DATA.—The Secretary shall require all recipients of contracts under this section to make available a
p.000463: standard dataset for purposes of subparagraph (A) in a standardized electronic format that enables
p.000463: transplant physicians to compare among and between bone marrow donors and cord blood units to ensure the
p.000463: best possible match for the patient.
p.000463: (4) DEFINITION.—The term ‘‘qualified cord blood bank’’ means a cord blood bank that—
p.000463: (A) has obtained all applicable Federal and State li- censes, certifications, registrations (including
p.000463: pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate
p.000463: and maintain a cord blood bank;
p.000463: (B) has implemented donor screening, cord blood col- lection practices, and processing methods intended to
p.000463: pro- tect the health and safety of donors and transplant recipi- ents to improve transplant outcomes, including
p.000463: with re- spect to the transmission of potentially harmful infections and other diseases;
p.000463: (C) is accredited by an accreditation entity recognized by the Secretary under subsection (b);
p.000463: (D) has established a system of strict confidentiality to protect the identity and privacy of patients and
p.000463: donors in accordance with existing Federal and State law;
p.000463: (E) has established a system for encouraging donation by a genetically diverse group of donors; and
p.000463: (F) has established a system to confidentially maintain linkage between a cord blood unit and a maternal
p.000463: donor.
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p.000467: January 30, 2020
p.000467:
p.000467: (1) APPLICATION.—To be eligible to enter into a contract under this section, an entity shall submit to the
p.000467: Secretary and obtain approval of an application at such time, in such man- ner, and containing such
p.000467: information as the Secretary shall by regulation prescribe.
p.000467: (2) CONSIDERATIONS.—In awarding contracts under this section, the Secretary shall give consideration to the
p.000467: continued safety of donors and patients and other factors deemed appro- priate by the Secretary.
p.000467: (l) ELIGIBILITY.—Entities eligible to receive a contract under this section shall include private nonprofit
p.000467: entities.
p.000467: (m) RECORDS.—
p.000467: (1) RECORDKEEPING.—Each recipient of a contract or sub- contract under subsection (a) shall keep such
p.000467: records as the Secretary shall prescribe, including records that fully disclose the amount and disposition by
p.000467: the recipient of the proceeds of the contract, the total cost of the undertaking in connection with which the
p.000467: contract was made, and the amount of the por- tion of the cost of the undertaking supplied by other sources,
p.000467: and such other records as will facilitate an effective audit.
p.000467: (2) EXAMINATION OF RECORDS.—The Secretary and the Comptroller General of the United States shall
p.000467: have access to any books, documents, papers, and records of the recipient of a contract or subcontract
p.000467: entered into under this section that are pertinent to the contract, for the purpose of conducting au- dits and
p.000467: examinations.
p.000467: (n) PENALTIES FOR DISCLOSURE.—Any person who discloses the content of any record referred to in subsection (d)(4)(D) or
p.000467: (f)(5)(A) without the prior written consent of the donor or potential donor with respect to whom the
p.000467: record is maintained, or in violation of the standards described in subsection (f)(5)(B), shall be imprisoned for
p.000467: not more than 2 years or fined in accordance with title 18, United States Code, or both.
p.000467: SEC. 379A. ø274l¿ STEM CELL THERAPEUTIC OUTCOMES DATABASE.
p.000467: (a) ESTABLISHMENT.—The Secretary shall by contract establish and maintain a scientific database of information
p.000467: relating to pa- tients who have been recipients of a stem cell therapeutics product (including bone marrow, cord
p.000467: blood, or other such product) from a donor.
p.000467: (b) INFORMATION.—The outcomes database shall include infor- mation in a standardized electronic format with
p.000467: respect to patients described in subsection (a), diagnosis, transplant procedures, re- sults, long-term
p.000467: follow-up, and such other information as the Sec- retary determines to be appropriate, to conduct an ongoing
p.000467: evalua- tion of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutics
p.000467: product from a donor.
p.000467: (c) ANNUAL REPORT ON PATIENT OUTCOMES.—The Secretary shall require the entity awarded a contract under
...

p.000469: activities regarding the prevention and control of injuries; and
p.000469: (3) make grants to States and, after consultation with State health agencies, to other public or nonprofit
p.000469: private enti- ties for the purpose of carrying out demonstration projects for the prevention and control of
p.000469: injuries at sites that are not sub- ject to the Occupational Safety and Health Act of 1970, includ- ing homes,
p.000469: elementary and secondary schools, and public build- ings.
p.000469: SEC. 392A. ø280b–1¿ PREVENTING OVERDOSES OF CONTROLLED SUB- STANCES.
p.000469: (a) EVIDENCE-BASED PREVENTION GRANTS.—
p.000469: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000469: (A) to the extent practicable, carry out and expand any evidence-based prevention activities described in
p.000469: para- graph (2);
p.000469: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000469: out such activity; and
p.000469: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity.
p.000469: (2) EVIDENCE-BASED PREVENTION ACTIVITIES.—An evidence- based prevention activity described in this paragraph is any
p.000469: of the following activities:
p.000469: (A) Improving the efficiency and use of a new or cur- rently operating prescription drug monitoring program,
p.000469: in- cluding by—
p.000469: (i) encouraging all authorized users (as specified by the State or other entity) to register with and
p.000469: use the program;
p.000469: (ii) enabling such users to access any updates to information collected by the program in as close to
p.000469: real-time as possible;
p.000469: (iii) improving the ease of use of such program;
p.000469: (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of
p.000469: controlled substances and any detection of in- appropriate prescribing or dispensing practices relat- ing to such
p.000469: substances;
p.000469: (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identi-
p.000469: fied, aggregate reports based on such analysis to State public health agencies, State substance abuse agen- cies,
p.000469: State licensing boards, and other appropriate
p.000469: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: PUBLIC HEALTH SERVICE ACT
p.000471: Sec. 392A
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p.000471: overdose data collection, analysis, and dissemination activity described in this paragraph is any of the
p.000471: following activities:
p.000471: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal
p.000471: overdoses of controlled substances.
p.000471: (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on
p.000471: such overdoses from appropriate sources such as toxicology re- ports, autopsy reports, death scene
p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
p.000471: coroners, medical examiners, and public health laboratories to im- prove accurate testing and
p.000471: standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of
p.000471: various opioid analogues to con- trolled substance overdoses.
p.000471: (F) Working to enable and encourage the access, ex- change, and use of information regarding controlled
p.000471: sub- stance overdoses among data sources and entities.
p.000471: (c) DEFINITIONS.—In this section:
p.000471: (1) CONTROLLED SUBSTANCE.—The term ‘‘controlled sub- stance’’ has the meaning given that term in section 102 of
p.000471: the Controlled Substances Act.
p.000471: (2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the mean- ing given that term in section 4 of the Indian
p.000471: Self-Determina- tion and Education Assistance Act.
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: PUBLIC HEALTH SERVICE ACT
p.000473: Sec. 393A
p.000473:
p.000473: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, section 399O of this Act, and
p.000473: section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), there is authorized
p.000473: to be appropriated $496,000,000 for each of fiscal years 2019 through 2023.
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: January 30, 2020
p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
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p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: Sec. 399A PUBLIC HEALTH SERVICE ACT 498
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
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p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
...

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p.000509: January 30, 2020
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p.000509: (C) provide for the annual publication of reports of cancer data under subsection (a); and
p.000509: (D) provide for the authorization under State law of the statewide cancer registry, including promulgation
p.000509: of regulations providing—
p.000509: (i) a means to assure complete reporting of cancer cases (as described in subsection (a)) to the statewide
p.000509: cancer registry by hospitals or other facilities pro- viding screening, diagnostic or therapeutic services
p.000509: to patients with respect to cancer;
p.000509: (ii) a means to assure the complete reporting of cancer cases (as defined in subsection (a)) to the state- wide
p.000509: cancer registry by physicians, surgeons, and all other health care practitioners diagnosing or providing
p.000509: treatment for cancer patients, except for cases directly referred to or previously admitted to a hospital or
p.000509: other facility providing screening, diagnostic or thera- peutic services to patients in that State and
p.000509: reported by those facilities;
p.000509: (iii) a means for the statewide cancer registry to access all records of physicians and surgeons, hos-
p.000509: pitals, outpatient clinics, nursing homes, and all other facilities, individuals, or agencies providing such serv- ices
p.000509: to patients which would identify cases of cancer or would establish characteristics of the cancer, treat- ment of
p.000509: the cancer, or medical status of any identified patient;
p.000509: (iv) for the reporting of cancer case data to the statewide cancer registry in such a format, with
p.000509: such data elements, and in accordance with such standards of quality timeliness and completeness, as may be es-
p.000509: tablished by the Secretary;
p.000509: (v) for the protection of the confidentiality of all cancer case data reported to the statewide cancer reg-
p.000509: istry, including a prohibition on disclosure to any per- son of information reported to the statewide cancer
p.000509: registry that identifies, or could lead to the identifica- tion of, an individual cancer patient, except for disclo-
p.000509: sure to other State cancer registries and local and State health officers;
p.000509: (vi) for a means by which confidential case data may in accordance with State law be disclosed to can- cer
p.000509: researchers for the purposes of cancer prevention, control and research;
p.000509: (vii) for the authorization or the conduct, by the statewide cancer registry or other persons and organi-
p.000509: zations, of studies utilizing statewide cancer registry data, including studies of the sources and causes
p.000509: of cancer, evaluations of the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic,
p.000509: rehabilita- tive, and preventative services and programs relating to cancer, and any other clinical,
p.000509: epidemiological, or other cancer research; and
p.000509: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000511: 511
p.000511: PUBLIC HEALTH SERVICE ACT
p.000511: Sec. 399C
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p.000511: January 30, 2020
p.000511: (viii) for protection for individuals complying with the law, including provisions specifying that no person shall be
p.000511: held liable in any civil action with respect to a cancer case report provided to the statewide cancer
p.000511: registry, or with respect to access to cancer case infor- mation provided to the statewide cancer registry.
p.000511: (d) RELATIONSHIP TO CERTAIN PROGRAMS.—
p.000511: (1) IN GENERAL.—This section may not be construed to act as a replacement for or diminishment of the program
p.000511: carried out by the Director of the National Cancer Institute and des- ignated by such Director as the
p.000511: Surveillance, Epidemiology, and End Results Program (SEER).
p.000511: (2) SUPPLANTING OF ACTIVITIES.—In areas where both such programs exist, the Secretary shall ensure that SEER support is
p.000511: not supplanted and that any additional activities are con- sistent with the guidelines provided for in
p.000511: subsection (c)(2) (C) and (D) and are appropriately coordinated with the existing SEER program.
p.000511: (3) TRANSFER OF RESPONSIBILITY.—The Secretary may not transfer administration responsibility for such SEER
p.000511: program from such Director.
p.000511: (4) COORDINATION.—To encourage the greatest possible ef- ficiency and effectiveness of Federally supported
p.000511: efforts with respect to the activities described in this subsection, the Sec- retary shall take steps to
p.000511: assure the appropriate coordination of programs supported under this part with existing Federally supported cancer
p.000511: registry programs.
p.000511: (e) REQUIREMENT REGARDING CERTAIN STUDY ON BREAST CAN- CER.—In the case of a grant under subsection (a) to any
p.000511: State spec- ified in subsection (b) of section 399E, the Secretary may establish such conditions regarding the receipt
p.000511: of the grant as the Secretary determines are necessary to facilitate the collection of data for the study carried out
p.000511: under such section.
p.000511: SEC. 399C. ø280e–1¿ PLANNING GRANTS REGARDING REGISTRIES.
p.000511: (a) IN GENERAL.—
...

p.000523: information as the Secretary may prescribe, including a description of the ac- tivities that the entity intends to
p.000523: carry out using amounts re- ceived under this part.
p.000523: SEC. 399J. ø280f–2¿ AUTHORIZATION OF APPROPRIATIONS.
p.000523: (a) IN GENERAL.—There are authorized to be appropriated to carry out this part, $27,000,000 for each of
p.000523: the fiscal years 1999 through 2003.
p.000523: (b) TASK FORCE.—From amounts appropriated for a fiscal year under subsection (a), the Secretary may use
p.000523: not to exceed
p.000523: $2,000,000 of such amounts for the operations of the National Task Force under section 399H(d).
p.000523: SEC. 399K. ø280f–3¿ SUNSET PROVISION.
p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
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p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
p.000525: families, including patient education regarding asthma management, family education on asthma
p.000525: management, and the distribution of materials, including displays and videos, to reinforce concepts
p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
...

p.000527: (iv) the student’s parent or guardian has com- pleted and submitted to the school any written docu-
p.000527: mentation required by the school, including the treat- ment plan formulated under clause (iii) and other doc-
p.000527: uments related to liability.
p.000527: (B) SCOPE.—An authorization granted under subpara- graph (A) must allow the student involved to possess
p.000527: and use his or her medication—
p.000527: (i) while in school;
p.000527: (ii) while at a school-sponsored activity, such as a sporting event; and
p.000527: (iii) in transit to or from school or school-spon- sored activities.
p.000527: (C) DURATION OF AUTHORIZATION.—An authorization granted under subparagraph (A)—
p.000527: (i) must be effective only for the same school and school year for which it is granted; and
p.000527: (ii) must be renewed by the parent or guardian each subsequent school year in accordance with this
p.000527: subsection.
p.000527: (D) BACKUP MEDICATION.—The State must require that backup medication, if provided by a student’s
p.000527: parent or guardian, be kept at a student’s school in a location to which the student has immediate access in
p.000527: the event of an asthma or anaphylaxis emergency.
p.000527: (E) MAINTENANCE OF INFORMATION.—The State must require that information described in subparagraphs
p.000527: (A)(iii) and (A)(iv) be kept on file at the student’s school in a location easily accessible in the event of an
p.000527: asthma or anaphylaxis emergency.
p.000527: (F) SCHOOL PERSONNEL ADMINISTRATION OF EPINEPH- RINE.—In determining the preference (if any) to be
p.000527: given to a State under this subsection, the Secretary shall give additional preference to a State that
p.000527: provides to the Sec- retary the certification described in subparagraph (G) and that requires that each public
p.000527: elementary school and sec- ondary school in the State—
p.000527: (i) permits trained personnel of the school to ad- minister epinephrine to any student of the school rea-
p.000527: sonably believed to be having an anaphylactic reac- tion;
p.000527: (ii) maintains a supply of epinephrine in a secure location that is easily accessible to trained personnel of
p.000527: the school for the purpose of administration to any student of the school reasonably believed to be having an
p.000527: anaphylactic reaction; and
p.000527: (iii) has in place a plan for having on the premises of the school during all operating hours of the school
p.000527: one or more individuals who are trained personnel of the school.
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533:
p.000533: vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this
p.000533: section revise the definition of such term to the extent determined by the Secretary to be appro-
p.000533: priate.
p.000533: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000533: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000533: SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
p.000533: (a) PROGRAM.—
p.000533: (1) IN GENERAL.—Each fiscal year, the Secretary, acting through the Director of the Centers for Disease
p.000533: Control and Prevention, in coordination with the heads of other depart- ments and agencies as appropriate,
p.000533: shall support States or lo- calities for the purpose of improving the efficiency and use of PDMPs, including—
p.000533: (A) establishment and implementation of a PDMP;
p.000533: (B) maintenance of a PDMP;
p.000533: (C) improvements to a PDMP by—
p.000533: (i) enhancing functional components to work to- ward—
p.000533: (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow;
p.000533: (II) more timely inclusion of data within a PDMP;
p.000533: (III) active management of the PDMP, in part by sending proactive or unsolicited reports to pro- viders to inform
p.000533: prescribing; and
p.000533: (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates,
p.000533: to the extent that State laws allow;
p.000533: (ii) in consultation with the Office of the National Coordinator for Health Information Technology, im- proving
p.000533: the intrastate interoperability of PDMPs by—
p.000533: (I) making PDMPs more actionable by inte- grating PDMPs within electronic health records and health
p.000533: information technology infrastructure; and
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p.000533: (II) linking PDMP data to other data systems
p.000533: within the State, including—
p.000533: (aa) the data of pharmacy benefit man- agers, medical examiners and coroners, and the State’s Medicaid
p.000533: program;
p.000533: (bb) worker’s compensation data; and
p.000533: (cc) prescribing data of providers of the Department of Veterans Affairs and the In- dian Health Service
p.000533: within the State;
p.000533: (iii) in consultation with the Office of the National Coordinator for Health Information Technology, im- proving
p.000533: the interstate interoperability of PDMPs through—
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: PUBLIC HEALTH SERVICE ACT
p.000535: Sec. 399O
p.000535:
p.000535: (I) sharing of dispensing data in near-real time across State lines; and
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p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: Sec. 399O PUBLIC HEALTH SERVICE ACT 536
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p.000535: time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse,
p.000535: addiction, over- dose, and other aggregate information, as appropriate and in compliance with applicable
p.000535: Federal and State laws and pro- vided that such reports shall not include protected health in- formation;
p.000535: and
p.000535: (4) may access information about prescriptions, such as claims data, to ensure that such prescribing and
p.000535: dispensing history is updated in as close to real-time as practicable, in compliance with applicable
p.000535: Federal and State laws and pro- vided that such information shall not include protected health information.
p.000535: (d) EVALUATION AND REPORTING.—As a condition on receipt of support under this section, the State shall
p.000535: report on interoper- ability with PDMPs of other States and Federal agencies, where appropriate,
p.000535: intrastate interoperability with health information technology systems such as electronic health records,
p.000535: health infor- mation exchanges, and e-prescribing, where appropriate, and whether or not the State
p.000535: provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a
p.000535: practitioner, where permitted) requests information about such patient.
p.000535: (e) EVALUATION AND REPORTING.—A State receiving support under this section shall provide the Secretary with
p.000535: aggregate non- identifiable information, as permitted by State law, to enable the Secretary—
p.000535: (1) to evaluate the success of the State’s program in achieving the purpose described in subsection
p.000535: (a); or
p.000535: (2) to prepare and submit to the Congress the report re- quired by subsection (i)(2).
p.000535: (f) EDUCATION AND ACCESS TO THE MONITORING SYSTEM.—A State receiving support under this section shall take
p.000535: steps to—
p.000535: (1) facilitate prescribers and dispensers, and their dele- gates, as permitted by State law, to use the PDMP, to
p.000535: the ex- tent practicable; and
p.000535: (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs.
p.000535: (g) ELECTRONIC FORMAT.—The Secretary may issue guidelines specifying a uniform electronic format for the
p.000535: reporting, sharing, and disclosure of information pursuant to PDMPs. To the extent possible, such
p.000535: guidelines shall be consistent with standards recog- nized by the Office of the National Coordinator for Health
p.000535: Informa- tion Technology.
p.000535: (h) RULES OF CONSTRUCTION.—
p.000535: (1) FUNCTIONS OTHERWISE AUTHORIZED BY LAW.—Nothing in this section shall be construed to restrict the
p.000535: ability of any authority, including any local, State, or Federal law enforce- ment, narcotics control,
p.000535: licensure, disciplinary, or program au- thority, to perform functions otherwise authorized by law.
p.000535: (2) ADDITIONAL PRIVACY PROTECTIONS.—Nothing in this section shall be construed as preempting any State
p.000535: from im- posing any additional privacy protections.
p.000535: (3) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this sec- tion shall be construed to supersede any Federal
p.000535: privacy or
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000537: Sec. 399O
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p.000537: confidentiality requirement, including the regulations promul- gated under section 264(c) of the Health Insurance
p.000537: Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 543 of this Act.
p.000537: (4) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in this section shall be construed to create a
p.000537: Federal private cause of action.
p.000537: (i) PROGRESS REPORT.—Not later than 3 years after the date of enactment of this section, the Secretary shall—
p.000537: (1) complete a study that—
p.000537: (A) determines the progress of grantees in establishing and implementing PDMPs consistent with this section;
p.000537: (B) provides an analysis of the extent to which the op- eration of PDMPs has—
p.000537: (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances;
p.000537: (ii) established or strengthened initiatives to en- sure linkages to substance use disorder treatment
p.000537: services; or
p.000537: (iii) affected patient access to appropriate care in States operating PDMPs;
p.000537: (C) determine the progress of grantees in achieving interstate interoperability and intrastate
p.000537: interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress
p.000537: and recommendations for addressing these barriers;
p.000537: (D) determines the progress of grantees in imple- menting near real-time electronic PDMPs;
p.000537: (E) provides an analysis of the privacy protections in place for the information reported to the PDMP
p.000537: in each State or locality receiving support under this section and any recommendations of the Secretary
p.000537: for additional Fed- eral or State requirements for protection of this informa- tion;
p.000537: (F) determines the progress of States or localities in implementing technological alternatives to centralized
p.000537: data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such
p.000537: alternatives to enhance the privacy and security of individually identifi- able data; and
p.000537: (G) evaluates the penalties that States or localities have enacted for the unauthorized use and disclosure of
p.000537: in- formation maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify
p.000537: as appropriate for purposes of subsection (a)(2); and
p.000537: (2) submit a report to the Congress on the results of the study.
p.000537: (j) ADVISORY COUNCIL.—
p.000537: (1) ESTABLISHMENT.—A State or locality may establish an advisory council to assist in the establishment,
p.000537: improvement, or maintenance of a PDMP consistent with this section.
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p.000537: hospital, or other person licensed, registered, or otherwise permitted, by the United States or the
p.000537: jurisdiction in which the individual prac- tices or does research, to distribute, dispense, conduct research with
p.000537: respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of
p.000537: professional practice or research.
p.000537: (9) The term ‘‘State’’ means each of the 50 States, the Dis- trict of Columbia, and any commonwealth or
p.000537: territory of the United States.
p.000537: (10) The term ‘‘ultimate user’’ means a person who has ob- tained from a dispenser, and who possesses, a
p.000537: controlled sub- stance for the person’s own use, for the use of a member of the person’s household, or for the
p.000537: use of an animal owned by the person or by a member of the person’s household.
p.000537: (11) The term ‘‘clinical workflow’’ means the integration of automated queries for prescription drug monitoring
p.000537: programs
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: PUBLIC HEALTH SERVICE ACT
p.000539: Sec. 399P
p.000539:
p.000539: data and analytics into health information technologies such as electronic health record systems, health information
p.000539: exchanges, and/or pharmacy dispensing software systems, thus stream- lining provider access through automated
p.000539: queries.
p.000539: SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYS- TEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING
p.000539: VIO- LENCE, SEXUAL ASSAULT, AND STALKING.
p.000539: (a) IN GENERAL.—The Secretary shall award grants for—
p.000539: (1) the development or enhancement and implementation of interdisciplinary training for health
p.000539: professionals, public health staff, and allied health professionals;
p.000539: (2) the development or enhancement and implementation of education programs for medical, nursing, dental,
p.000539: and other health profession students and residents to prevent and re- spond to domestic violence, dating
p.000539: violence, sexual assault, and stalking; and
p.000539: (3) the development or enhancement and implementation of comprehensive statewide strategies to improve the
p.000539: response of clinics, public health facilities, hospitals, and other health settings (including behavioral
p.000539: and mental health programs) to domestic violence, dating violence, sexual assault, and stalking.
p.000539: (b) USE OF FUNDS.—
p.000539: (1) REQUIRED USES.—Amounts provided under a grant under this section shall be used to—
p.000539: (A) fund interdisciplinary training and education pro- grams under paragraphs (1) and (2) of
p.000539: subsection (a) that—
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p.000539: (i) the implementation, dissemination, and evalua- tion of policies and procedures to guide health profes-
p.000539: sionals and public health staff in identifying and re- sponding to domestic violence, dating violence,
p.000539: sexual assault, and stalking, including strategies to ensure that health information is maintained in a
p.000539: manner that protects the patient’s privacy and safety, and safely uses health information technology to
p.000539: improve documentation, identification, assessment, treatment, and follow-up care;
p.000539: (ii) the development of on-site access to services to address the safety, medical, and mental health needs of
p.000539: patients by increasing the capacity of existing health care professionals and public health staff to ad-
p.000539: dress domestic violence, dating violence, sexual as- sault, and stalking, or by contracting with or
p.000539: hiring domestic or sexual assault advocates to provide such services or to model other services
p.000539: appropriate to the geographic and cultural needs of a site;
p.000539: (iii) the development of measures and methods for the evaluation of the practice of identification, inter-
p.000539: vention, and documentation regarding victims of do- mestic violence, dating violence, sexual assault, and
p.000539: stalking, including the development and testing of quality improvement measurements, in accordance
p.000539: with the multi-stakeholder and quality measurement processes established under paragraphs (7) and (8) of
p.000539: section 1890(b) and section 1890A of the Social Secu- rity Act (42 U.S.C. 1395aaa(b)(7) and (8); 42
p.000539: U.S.C. 1890A); and
p.000539: (iv) the provision of training and follow-up tech- nical assistance to health care professionals, and pub- lic
p.000539: health staff, and allied health professionals to iden- tify, assess, treat, and refer clients who are victims of
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p.000547: grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the
p.000547: collection, analysis, and reporting of data on ALS and other motor neuron disorders that can be con- fused with ALS,
p.000547: misdiagnosed as ALS, and in some cases progress to ALS after receiving the report under subsection (b)(3).
p.000547: (d) COORDINATION WITH STATE, LOCAL, AND FEDERAL REG-
p.000547: ISTRIES.—
p.000547: (1) 106 IN GENERAL.—In establishing the National ALS Reg- istry under subsection (a), the Secretary, acting
p.000547: through the Director of the Centers for Disease Control and Prevention, may—
p.000547: (A) identify, build upon, expand, and coordinate among existing data and surveillance systems, surveys, registries, and
p.000547: other Federal public health and environmental infra- structure wherever possible, which may include—
p.000547: (i) any registry pilot projects previously supported by the Centers for Disease Control and Prevention;
p.000547: (ii) the Department of Veterans Affairs ALS Reg- istry;
p.000547: (iii) the DNA and Cell Line Repository of the Na- tional Institute of Neurological Disorders and Stroke Human
p.000547: Genetics Resource Center at the National In- stitutes of Health;
p.000547: (iv) Agency for Toxic Substances and Disease Reg- istry studies, including studies conducted in Illinois,
p.000547: Missouri, El Paso and San Antonio, Texas, and Massa- chusetts;
p.000547: (v) State-based ALS registries;
p.000547: (vi) the National Vital Statistics System; and
p.000547: (vii) any other existing or relevant databases that collect or maintain information on those motor neuron diseases
p.000547: recommended by the Advisory Committee es- tablished in subsection (b); and
p.000547: (B) provide for research access to ALS data as rec- ommended by the Advisory Committee established in sub-
p.000547: section (b) to the extent permitted by applicable statutes and regulations and in a manner that protects
p.000547: personal privacy consistent with applicable privacy statutes and regulations.
p.000547: (C) COORDINATION WITH NIH AND DEPARTMENT OF VET- ERANS AFFAIRS.—Consistent with applicable privacy stat-
p.000547: utes and regulations, the Secretary may ensure that epide- miological and other types of information obtained
p.000547: under subsection (a) is made available to the National Institutes of Health and the Department of Veterans Affairs.
p.000547: (e) DEFINITION.—For the purposes of this section, the term ‘‘na- tional voluntary health association’’ means a national
p.000547: non-profit or-
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p.000547: 106 So in law. Subsection (d) (as added by section 2 of Public Law 110–373) does not include a
p.000547: paragraph (2).
p.000547: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000549: 549
p.000549: PUBLIC HEALTH SERVICE ACT
p.000549: Sec. 399S–1
p.000549:
p.000549: ganization with chapters or other affiliated organizations in States throughout the United States with experience
p.000549: serving the popu- lation of individuals with ALS and have demonstrated experience in ALS research, care, and
p.000549: patient services.
p.000549: SEC. 399S–1. ø280g–7a¿ SURVEILLANCE OF NEUROLOGICAL DISEASES.
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p.000549:
p.000549: (B) have demonstrated experience in research, care, or patient services;
p.000549: (3) health information technology experts or other informa- tion management specialists;
p.000549: (4) clinicians with expertise in neurological diseases; and
p.000549: (5) research scientists with experience conducting translational research or utilizing surveillance
p.000549: systems for sci- entific research purposes.
p.000549: (e) GRANTS.—The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or
p.000549: private non- profit entities to carry out activities under this section.
p.000549: (f) COORDINATION WITH OTHER FEDERAL, STATE, AND LOCAL AGENCIES.—Subject to subsection (h), the Secretary
p.000549: shall—
p.000549: (1) make information and analysis in the National Neuro- logical Conditions Surveillance System available, as
p.000549: appro- priate—
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p.000549: (A) to Federal departments and agencies, such as the National Institutes of Health and the Department of
p.000549: Vet- erans Affairs; and
p.000549: (B) to State and local agencies; and
p.000549: (2) identify, build upon, leverage, and coordinate among existing data and surveillance systems, surveys,
p.000549: registries, and other Federal public health infrastructure, wherever prac- ticable.
p.000549: (g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary shall ensure that information and analysis in
p.000549: the National Neuro- logical Conditions Surveillance System are available, as appro- priate, to the public,
p.000549: including researchers.
p.000549: (h) PRIVACY.—The Secretary shall ensure that information and analysis in the National Neurological Conditions
p.000549: Surveillance Sys- tem are made available only to the extent permitted by applicable Federal and State law, and in a
p.000549: manner that protects personal pri- vacy, to the extent required by applicable Federal and State pri- vacy
p.000549: law, at a minimum.
p.000549: (i) REPORTS.—
p.000549: (1) REPORT ON INFORMATION AND ANALYSES.—Not later than 1 year after the date on which any system is
p.000549: established under this section, the Secretary shall submit an interim re- port to the Committee on
p.000549: Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Com- merce of the
p.000549: House of Representatives regarding aggregate in- formation collected pursuant to this section and epidemiolog-
p.000549: ical analyses, as appropriate. Such report shall be posted on the Internet website of the Department of Health
p.000549: and Human Services and shall be updated biennially.
p.000549: (2) IMPLEMENTATION REPORT.—Not later than 4 years after the date of the enactment of this section, the
p.000549: Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall
p.000549: include information on—
p.000549: (A) the development and maintenance of the National Neurological Conditions Surveillance System;
p.000549: (B) the type of information collected and stored in the surveillance system;
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p.000551: (3) POSTNATALLY DIAGNOSED CONDITION.—The term ‘‘postnatally diagnosed condition’’ means any health
p.000551: condition identified during the 12-month period beginning at birth.
p.000551: (4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘pre- natally diagnosed condition’’ means any fetal health
p.000551: condition identified by prenatal genetic testing or prenatal screening pro- cedures.
p.000551: (5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diag- nostic or screening tests offered to pregnant women
p.000551: seeking routine prenatal care that are administered on a required or recommended basis by a health care
p.000551: provider based on medical history, family background, ethnic background, previous test results, or other risk
p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
p.000551:
p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
p.000551: (ii) the expansion and further development of the National Dissemination Center for Children with Dis-
p.000551: abilities, so that such Center can more effectively con- duct outreach to new and expecting parents and pro-
p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
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p.000553: (2) to educate and provide guidance regarding effective strategies to promote positive health behaviors and
p.000553: discourage risky health behaviors;
p.000553: (3) to educate and provide outreach regarding enrollment in health insurance including the Children’s Health
p.000553: Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act and
p.000553: Medicaid under title XIX of such Act;
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: PUBLIC HEALTH SERVICE ACT
p.000555: Sec. 399V
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p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
p.000555: organizations in order to increase access to quality healthcare services and to eliminate duplicative care; or
p.000555: (5) to educate, guide, and provide home visitation services regarding maternal health and prenatal care.
p.000555: (c) APPLICATION.—Each eligible entity that desires to receive a grant under subsection (a) shall submit an
p.000555: application to the Sec- retary, at such time, in such manner, and accompanied by such in- formation as the Secretary
p.000555: may require.
p.000555: (d) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to applicants that—
p.000555: (1) propose to target geographic areas—
p.000555: (A) with a high percentage of residents who are eligi- ble for health insurance but are uninsured
p.000555: or under- insured;
p.000555: (B) with a high percentage of residents who suffer from chronic diseases; or
p.000555: (C) with a high infant mortality rate;
p.000555: (2) have experience in providing health or health-related social services to individuals who are underserved
p.000555: with respect to such services; and
p.000555: (3) have documented community activity and experience with community health workers.
p.000555: (e) COLLABORATION WITH ACADEMIC INSTITUTIONS AND THE ONE-STOP DELIVERY SYSTEM.—The Secretary shall
p.000555: encourage com- munity health worker programs receiving funds under this section to collaborate with academic
p.000555: institutions and one-stop delivery sys- tems under section 121(e) of the Workforce Innovation and Oppor- tunity Act.
p.000555: Nothing in this section shall be construed to require such collaboration.
p.000555: (f) EVIDENCE-BASED INTERVENTIONS.—The Secretary shall en- courage community health worker programs
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p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
p.000559: members, and health care providers, on topics such as the prevalence of such disease, the effect of
p.000559: such disease on individuals of all ages, and the importance of long-term, special- ized care for individuals with such
p.000559: disease.
p.000559: (d) PUBLIC ACCESS.—The Secretary shall ensure that, subject to subsection (e), information collected under
p.000559: this section is made available, as appropriate, to the public, including researchers.
p.000559: (e) PATIENT PRIVACY.—The Secretary shall ensure that the data and information collected under this section
p.000559: are made avail- able in a manner that, at a minimum, protects personal privacy to the extent required by applicable
p.000559: Federal and State law.
p.000559: (f) ELIGIBILITY FOR GRANTS.—To be eligible to receive a grant under subsection (a)(3), an entity shall—
p.000559: (1) be a public or private nonprofit entity with specialized experience in congenital heart disease; and
p.000559: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000559: Sec- retary may require.
p.000559: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000559: $10,000,000 for each of fiscal years 2020 through 2024.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000559:
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p.000561: PUBLIC HEALTH SERVICE ACT
p.000561: Sec. 399V–4
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p.000561: safe- ty and the quality of health care.
p.000561: (2) ALTERNATIVE TO CURRENT TORT LITIGATION.—Each State desiring a grant under subsection (a) shall
p.000561: demonstrate how the proposed alternative described in paragraph (1)(A)—
p.000561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000561: Sec. 399V–4 PUBLIC HEALTH SERVICE ACT 562
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p.000561: January 30, 2020
p.000561:
p.000561: (A) makes the medical liability system more reliable by increasing the availability of prompt and fair
p.000561: resolution of disputes;
p.000561: (B) encourages the efficient resolution of disputes;
p.000561: (C) encourages the disclosure of health care errors;
p.000561: (D) enhances patient safety by detecting, analyzing, and helping to reduce medical errors and adverse
p.000561: events;
p.000561: (E) improves access to liability insurance;
p.000561: (F) fully informs patients about the differences in the alternative and current tort litigation;
p.000561: (G) provides patients the ability to opt out of or volun- tarily withdraw from participating in the alternative
p.000561: at any time and to pursue other options, including litigation, outside the alternative;
p.000561: (H) would not conflict with State law at the time of the application in a way that would prohibit the
p.000561: adoption of an alternative to current tort litigation; and
p.000561: (I) would not limit or curtail a patient’s existing legal rights, ability to file a claim in or access
p.000561: a State’s legal system, or otherwise abrogate a patient’s ability to file a medical malpractice claim.
p.000561: (3) SOURCES OF COMPENSATION.—Each State desiring a grant under subsection (a) shall identify the sources
p.000561: from and methods by which compensation would be paid for claims re- solved under the proposed alternative to
p.000561: current tort litigation, which may include public or private funding sources, or a com- bination of such sources.
p.000561: Funding methods shall to the extent practicable provide financial incentives for activities that im- prove
p.000561: patient safety.
p.000561: (4) SCOPE.—
p.000561: (A) IN GENERAL.—Each State desiring a grant under subsection (a) shall establish a scope of jurisdiction
p.000561: (such as Statewide, designated geographic region, a designated area of health care practice, or a
p.000561: designated group of health care providers or health care organizations) for the proposed alternative to current tort
p.000561: litigation that is suffi- cient to evaluate the effects of the alternative. No scope of jurisdiction shall be
p.000561: established under this paragraph that is based on a health care payer or patient population.
p.000561: (B) NOTIFICATION OF PATIENTS.—A State shall dem- onstrate how patients would be notified that they are
p.000561: re- ceiving health care services that fall within such scope, and the process by which they may opt out
p.000561: of or volun- tarily withdraw from participating in the alternative. The decision of the patient whether
p.000561: to participate or continue participating in the alternative process shall be made at any time and shall not
p.000561: be limited in any way.
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p.000565: (D) the medical liability environment;
p.000565: (E) health care quality;
p.000565: (F) patient safety in terms of detecting, analyzing, and helping to reduce medical errors and adverse events;
p.000565: (G) patient and health care provider and organization satisfaction with the alternative under subsection (a) and
p.000565: with the medical liability environment; and
p.000565: (H) impact on utilization of medical services, appro- priately adjusted for risk.
p.000565: (4) FUNDING.—The Secretary shall reserve 5 percent of the amount appropriated in each fiscal year under
p.000565: subsection (k) to carry out this subsection.
p.000565: (h) MEDPAC AND MACPAC REPORTS.—
p.000565: (1) MEDPAC.—The Medicare Payment Advisory Commis- sion shall conduct an independent review of the alternatives to
p.000565: current tort litigation that are implemented under grants under subsection (a) to determine the
p.000565: impact of such alter- natives on the Medicare program under title XVIII of the So- cial Security Act, and
p.000565: its beneficiaries.
p.000565: (2) MACPAC.—The Medicaid and CHIP Payment and Ac- cess Commission shall conduct an independent review of
p.000565: the alternatives to current tort litigation that are implemented under grants under subsection (a) to
p.000565: determine the impact of such alternatives on the Medicaid or CHIP programs under ti- tles XIX and XXI of the
p.000565: Social Security Act, and their bene- ficiaries.
p.000565: (3) REPORTS.—Not later than December 31, 2016, the Medicare Payment Advisory Commission and the Medicaid
p.000565: and CHIP Payment and Access Commission shall each submit to Congress a report that includes the findings and
p.000565: recommenda-
p.000565: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000565: Sec. 399V–5 PUBLIC HEALTH SERVICE ACT 566
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p.000565: tions of each respective Commission based on independent re- views conducted under paragraphs (1) and
p.000565: (2), including an analysis of the impact of the alternatives reviewed on the effi- ciency and effectiveness of the
p.000565: respective programs.
p.000565: (i) OPTION TO PROVIDE FOR INITIAL PLANNING GRANTS.—Of the funds appropriated pursuant to subsection (k),
p.000565: the Secretary may use a portion not to exceed $500,000 per State to provide planning grants to such States for the
p.000565: development of demonstration project applications meeting the criteria described in subsection (c). In se- lecting
p.000565: States to receive such planning grants, the Secretary shall give preference to those States in which
p.000565: State law at the time of the application would not prohibit the adoption of an alternative to current tort
p.000565: litigation.
p.000565: (j) DEFINITIONS.—In this section:
p.000565: (1) HEALTH CARE SERVICES.—The term ‘‘health care serv- ices’’ means any services provided by a health care
p.000565: provider, or by any individual working under the supervision of a health care provider, that relate to—
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p.000573: cents by health professionals in accordance with estab- lished standards, community practice, reporting
p.000573: laws, and other State laws, including parental consent and notifica- tion laws that are not inconsistent
p.000573: with Federal law; and
p.000573: (C) does not perform abortion services.
p.000573: (b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants for the costs of the operation of school-based health
p.000573: centers (referred to in this section as ‘‘SBHCs’’) that meet the requirements of this section.
p.000573: (c) APPLICATIONS.—To be eligible to receive a grant under this section, an entity shall—
p.000573: (1) be an SBHC (as defined in subsection (a)(3)); and
p.000573: (2) submit to the Secretary an application at such time, in such manner, and containing—
p.000573: (A) evidence that the applicant meets all criteria nec- essary to be designated an SBHC;
p.000573: (B) evidence of local need for the services to be pro- vided by the SBHC;
p.000573: (C) an assurance that—
p.000573: (i) SBHC services will be provided to those chil- dren and adolescents for whom parental or guardian
p.000573: consent has been obtained in cooperation with Fed- eral, State, and local laws governing health care serv- ice
p.000573: provision to children and adolescents;
p.000573: (ii) the SBHC has made and will continue to make every reasonable effort to establish and maintain col-
p.000573: laborative relationships with other health care pro- viders in the catchment area of the SBHC;
p.000573: (iii) the SBHC will provide on-site access during the academic day when school is in session and 24-
p.000573: hour coverage through an on-call system and through its backup health providers to ensure access to
p.000573: serv- ices on a year-round basis when the school or the SBHC is closed;
p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
p.000573: school personnel, such as administrators, teachers, nurses, counselors, and support personnel, as well
p.000573: as with other community providers co-located at the school;
p.000573: (v) the SBHC sponsoring facility assumes all re- sponsibility for the SBHC administration, operations, and
p.000573: oversight; and
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
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p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
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p.000583: health of individuals with autism spectrum disorder or other devel- opmental disabilities across the lifespan of
p.000583: such individuals, de- velop guidelines for those interventions, and disseminate informa- tion related to such
p.000583: research and guidelines.
p.000583: (g) SUNSET.—This section shall not apply after September 30, 2024.
p.000583: SEC. 399CC. ø280i–2¿ INTERAGENCY AUTISM COORDINATING COM- MITTEE.
p.000583: (a) ESTABLISHMENT.—The Secretary shall establish a com- mittee, to be known as the ‘‘Interagency Autism
p.000583: Coordinating Com- mittee’’ (in this section referred to as the ‘‘Committee’’), to coordi- nate all efforts
p.000583: within the Department of Health and Human Serv- ices concerning autism spectrum disorder.
p.000583: (b) RESPONSIBILITIES.—In carrying out its duties under this section, the Committee shall—
p.000583: (1) monitor autism spectrum disorder research, and to the extent practicable services and support activities, across
p.000583: all rel- evant Federal departments and agencies, including coordina- tion of Federal activities with respect
p.000583: to autism spectrum dis- order;
p.000583: (2) develop a summary of advances in autism spectrum disorder research related to causes, prevention,
p.000583: treatment, early screening, diagnosis or rule out, interventions, including school and community-based
p.000583: interventions, and access to serv- ices and supports for individuals with autism spectrum dis- order across the
p.000583: lifespan of such individuals;
p.000583: (3) make recommendations to the Secretary regarding any appropriate changes to such activities, including with
p.000583: respect to the strategic plan developed under paragraph (5);
p.000583: (4) make recommendations to the Secretary regarding pub- lic participation in decisions relating to autism
p.000583: spectrum dis- order, and the process by which public feedback can be better integrated into such decisions;
p.000583: (5) develop a strategic plan for the conduct of, and support for, autism spectrum disorder research,
p.000583: including as prac- ticable for services and supports, for individuals with an au- tism spectrum disorder
p.000583: across the lifespan of such individuals and the families of such individuals, which shall include—
p.000583: (A) proposed budgetary requirements; and
p.000583: (B) recommendations to ensure that autism spectrum disorder research, and services and support activities
p.000583: to the extent practicable, of the Department of Health and Human Services and of other Federal
p.000583: departments and agencies are not unnecessarily duplicative; and
p.000583: (6) submit to Congress and the President—
p.000583: (A) an annual update on the summary of advances de- scribed in paragraph (2); and
p.000583: (B) an annual update to the strategic plan described in paragraph (5), including any progress made in achieving
p.000583: the goals outlined in such strategic plan.
p.000583: (c) MEMBERSHIP.—
p.000583: (1) FEDERAL MEMBERSHIP.—The Committee shall be com- posed of the following Federal members—
p.000583: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000611: the clinical trial concluded according to the prespecified protocol or was terminated.
p.000611: (vi) DEVICE.—The term ‘‘device’’ means a device as defined in section 201(h) of the Federal Food, Drug, and
p.000611: Cosmetic Act.
p.000611: (vii) DRUG.—The term ‘‘drug’’ means a drug as de- fined in section 201(g) of the Federal Food, Drug, and Cosmetic Act
p.000611: or a biological product as defined in sec- tion 351 of this Act.
p.000611: (viii) ONGOING.—The term ‘‘ongoing’’ means, with respect to a clinical trial of a drug or a device and
p.000611: to a date, that—
p.000611: (I) 1 or more patients is enrolled in the clin- ical trial; and
p.000611: (II) the date is before the completion date of the clinical trial.
p.000611: (ix) RESPONSIBLE PARTY.—The term ‘‘responsible party’’, with respect to a clinical trial of a drug or de- vice,
p.000611: means—
p.000611: (I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regula- tions (or any
p.000611: successor regulation)); or
p.000611: (II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, con-
p.000611: tractor, or awardee, so long as the principal inves- tigator is responsible for conducting the trial, has access to
p.000611: and control over the data from the clin- ical trial, has the right to publish the results of the trial,
p.000611: and has the ability to meet all of the re- quirements under this subsection for the submis- sion of clinical
p.000611: trial information.
p.000611: (B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for each
p.000611: appli- cable clinical trial shall submit the identity and contact in- formation of such responsible party to the
p.000611: Secretary at the time of submission of clinical trial information under para- graph (2).
p.000611: (2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
p.000611: (A) IN GENERAL.—
p.000611: (i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subse- quent
p.000611: progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accord-
p.000611: ance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (re-
p.000611: ferred to in this subsection as the ‘‘registry data bank’’). The Director of NIH shall ensure that the
p.000611: reg- istry data bank is made publicly available through the Internet.
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: PUBLIC HEALTH SERVICE ACT
p.000613: Sec. 402
p.000613:
p.000613: (ii) CONTENT.—The clinical trial information re- quired to be submitted under this paragraph for an
p.000613: applicable clinical trial shall include—
p.000613: (I) descriptive information, including—
p.000613: (aa) a brief title, intended for the lay pub-
p.000613: lic;
p.000613: (bb) a brief summary, intended for the lay
p.000613: public;
p.000613: (cc) the primary purpose; (dd) the study design;
p.000613: (ee) for an applicable drug clinical trial, the study phase;
p.000613: (ff) study type;
p.000613: (gg) the primary disease or condition being studied, or the focus of the study;
p.000613: (hh) the intervention name and interven- tion type;
p.000613: (ii) the study start date;
p.000613: (jj) the expected completion date;
p.000613: (kk) the target number of subjects; and (ll) outcomes, including primary and sec-
p.000613: ondary outcome measures;
p.000613: (II) recruitment information, including— (aa) eligibility criteria;
p.000613: (bb) gender; (cc) age limits;
p.000613: (dd) whether the trial accepts healthy vol- unteers;
p.000613: (ee) overall recruitment status; (ff) individual site status; and
p.000613: (gg) in the case of an applicable drug clin- ical trial, if the drug is not approved under section 505 of
p.000613: the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.000613: there is ex- panded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act
p.000613: for those who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such
p.000613: access;
p.000613: (III) location and contact information, includ- ing—
p.000613:
p.000613:
p.000613: and
p.000613: (aa) the name of the sponsor;
p.000613: (bb) the responsible party, by official title;
p.000613: (cc) the facility name and facility contact
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p.000613: information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.000613: through which such location in- formation may be accessed); and
p.000613: (IV) administrative data (which the Secretary may make publicly available as necessary), includ- ing—
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: Sec. 402 PUBLIC HEALTH SERVICE ACT 614
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p.000617: under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome
p.000617: meas- ures for each arm of the clinical trial, including the re- sults of scientifically appropriate tests of the
p.000617: statistical significance of such outcome measures.
p.000617: (iii) POINT OF CONTACT.—A point of contact for sci- entific information about the clinical trial results.
p.000617: (iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to com- ply with
p.000617: applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and
p.000617: the principal investigator (unless the spon- sor is an employer of the principal investigator) that
p.000617: restricts in any manner the ability of the principal in- vestigator, after the completion date of the trial, to
p.000617: discuss the results of the trial at a scientific meeting or any other public or private forum, or to
p.000617: publish in a scientific or academic journal information concerning the results of the trial.
p.000617: (D) EXPANDED REGISTRY AND RESULTS DATA BANK.—
p.000617: (i) EXPANSION BY RULEMAKING.—To provide more complete results information and to enhance patient access to
p.000617: and understanding of the results of clinical trials, not later than 3 years after the date of the en-
p.000617: actment of the Food and Drug Administration Amend- ments Act of 2007, the Secretary shall by regulation expand
p.000617: the registry and results data bank as provided under this subparagraph.
p.000617: (ii) CLINICAL TRIALS.—
p.000617: (I) APPROVED PRODUCTS.—The regulations under this subparagraph shall require the inclu- sion of the
p.000617: results information described in clause
p.000617: (iii) for—
p.000617: (aa) each applicable drug clinical trial for a drug that is approved under section 505 of the Federal Food,
p.000617: Drug, and Cosmetic Act or licensed under section 351 of this Act; and
p.000617: (bb) each applicable device clinical trial for a device that is cleared under section 510(k) of
p.000617: the Federal Food, Drug, and Cos- metic Act or approved under section 515 or 520(m) of such Act.
p.000617: (II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.000617: information described in clause
p.000617: (iii) shall be required for—
p.000617: (aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal Food, Drug, and
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p.000663: SEC. 408. ø284c¿ (a)(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal
p.000663: year for administra- tive expenses of the National Institutes of Health may not exceed an amount which is
p.000663: 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
p.000663: (2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing
p.000663: Research, 11 the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G.
p.000663: Magnuson Clinical Center, and the Office of Medical Applications of Research.
p.000663: (3) For purposes of paragraph (1), the term ‘‘administrative ex- penses’’ means expenses incurred for the support
p.000663: of activities rel- evant to the award of grants, contracts, and cooperative agree- ments and expenses
p.000663: incurred for general administration of the sci- entific programs and activities of the National Institutes of Health.
p.000663: (b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of
p.000663: Health shall be avail- able for payment of nurses and allied health professionals in ac- cordance with
p.000663: payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38,
p.000663: United States Code, for nurses of the Department of Veterans Affairs.
p.000663: DEFINITIONS
p.000663: SEC. 409. ø284d¿ (a) HEALTH SERVICE RESEARCH.—For pur-
p.000663: poses of this title, the term ‘‘health services research’’ means re- search endeavors that study the impact
p.000663: of the organization, financ- ing and management of health services on the quality, cost, access to and outcomes of
p.000663: care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical
p.000663: condi- tions.
p.000663: (b) CLINICAL RESEARCH.—As used in this title, the term ‘‘clin- ical research’’ means patient oriented
p.000663: clinical research conducted with human subjects, or research on the causes and consequences
p.000663:
p.000663:
p.000663:
p.000663:
p.000663: January 30, 2020
p.000663: 10 Section 407 of the Public Health Service Act was repealed by section 104(b)(1)(C) of Public Law 109–482 (120 Stat.
p.000663: 3693).
p.000663: 11 See footnote 2 for section 403(5).
p.000663: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000663:
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p.000663:
p.000663: Sec. 409A PUBLIC HEALTH SERVICE ACT 664
p.000663:
p.000663: of disease in human populations involving material of human ori- gin (such as tissue specimens and cognitive
p.000663: phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient
p.000663: setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behav- ioral
p.000663: studies, outcomes research or health services research, or de- veloping new technologies, therapeutic
p.000663: interventions, or clinical trials.
p.000663: RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND RELATED BONE DISORDERS
...

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p.000667: PUBLIC HEALTH SERVICE ACT
p.000667: Sec. 409C
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p.000667:
p.000667: January 30, 2020
p.000667: agnosis, early and ongoing detection, prevention, and treat- ment of autism spectrum disorder across the
p.000667: lifespan. The cen- ters, as a group, shall conduct research including the fields of developmental
p.000667: neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral
p.000667: psychology, and clinical psychology.
p.000667: (3) SERVICES FOR PATIENTS.—
p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
...

p.000689: described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and
p.000689: demographic information of chil- dren, adolescents, and young adults with selected cancer subtypes (and
p.000689: their recurrences) for which current treatments are least effective, in order to achieve a better
p.000689: understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of
p.000689: treatments for such cancers.
p.000689: (2) USE OF FUNDS.—Amounts received under an award under paragraph (1) may be used to carry out the following:
p.000689: (A) Collect and store high-quality, donated biospeci- mens and associated clinical and demographic information on
p.000689: children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children,
p.000689: adoles- cents, and young adults with cancer enrolled in clinical trials for whom current treatments are
p.000689: least effective. Ac- tivities under this subparagraph may include storage of biospecimens and associated
p.000689: clinical and demographic data at existing biorepositories supported by the National Can- cer Institute.
p.000689: (B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated
p.000689: clinical and demographic data from children, adolescents, and young adults with cancer for the
p.000689: purposes of research by scientists and qualified health care professionals.
p.000689: (C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical
p.000689: and demographic data from researchers and other quali- fied health care professionals.
p.000689: (D) Provide access to biospecimens and clinical and de- mographic data from children, adolescents, and
p.000689: young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—
p.000689: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000689:
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p.000689:
p.000691: 691
p.000691: PUBLIC HEALTH SERVICE ACT
p.000691: Sec. 417E
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p.000691: January 30, 2020
p.000691: (i) consistent with the procedures established pur- suant to subparagraph (C);
p.000691: (ii) only to the extent permitted by applicable Fed- eral and State law; and
p.000691: (iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy
p.000691: law, at minimum.
p.000691: (3) NO REQUIREMENT.—No child, adolescent, or young adult with cancer shall be required under this
...

p.000727: for information provided through the toll-free telephone line established under subsection (b)(2), and may
p.000727: make exceptions to such fees for individuals and or- ganizations who are not financially able to pay such fees.
p.000727: (d) In order to receive a grant or contract under this section, an organization shall submit an
p.000727: application to the Director of the Institute. Such application shall contain—
p.000727: (1) information demonstrating that such organization has a network of contacts which will enable such
p.000727: organization to receive information necessary to the operation of the central computerized information system
p.000727: described in subsection (b)(1);
p.000727: (2) information demonstrating that, by the end of fiscal year 1991, such organization will be financially
p.000727: able to, and will, carry out the activities described in subsection (b) without a grant or contract from the Federal
p.000727: Government; and
p.000727: (3) such other information as the Director may prescribe.
p.000727: ALZHEIMER’S DISEASE REGISTRY
p.000727: SEC. 445G. ø285e–9¿ (a) IN GENERAL.—The Director of the In- stitute may make a grant to develop a registry for the
p.000727: collection of epidemiological data about Alzheimer’s disease and its incidence in the United States, to train personnel
p.000727: in the collection of such data, and for other matters respecting such disease.
p.000727: (b) QUALIFICATIONS.—To qualify for a grant under subsection
p.000727: (a) an applicant shall—
p.000727: (1) be an accredited school of medicine or public health which has expertise in the collection of
p.000727: epidemiological data about individuals with Alzheimer’s disease and in the develop- ment of disease registries, and
p.000727: (2) have access to a large patient population, including a patient population representative of
p.000727: diverse ethnic back- grounds.
p.000727:
p.000727: January 30, 2020 As Amended Through P.L. 116-94,
p.000727: Enacted December 20, 2019
p.000727:
p.000727:
p.000727:
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p.000727: Sec. 445H PUBLIC HEALTH SERVICE ACT 728
p.000727:
p.000727: AGING PROCESSES REGARDING WOMEN
p.000727: SEC. 445H. ø285e–10¿ The Director of the Institute, in addition to other special functions specified in section
p.000727: 444 and in coopera- tion with the Directors of the other national research institutes and agencies of the
p.000727: National Institutes of Health, shall conduct re- search into the aging processes of women, with particular
p.000727: emphasis given to the effects of menopause and the physiological and behav- ioral changes occurring during the
p.000727: transition from pre- to post- menopause, and into the diagnosis, disorders, and complications re- lated to aging
p.000727: and loss of ovarian hormones in women.
p.000727: SEC. 445I. ø285e–10a¿ ALZHEIMER’S CLINICAL RESEARCH AND TRAIN- ING AWARDS.
p.000727: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
...

p.000765: and exchange of scientific and other information important to the progress of medicine and to the public
p.000765: health, there is established the National Library of Medicine (hereafter in this part referred to as the
p.000765: ‘‘Li- brary’’).
p.000765: (b) The Secretary, through the Library and subject to sub- section (d), shall—
p.000765: (1) acquire and preserve books, periodicals, prints, films, recordings, and other library materials
p.000765: pertinent to medicine;
p.000765: (2) organize the materials specified in paragraph (1) by ap- propriate cataloging, indexing, and bibliographical
p.000765: listings;
p.000765: (3) publish and disseminate the catalogs, indexes, and bib- liographies referred to in paragraph (2);
p.000765: (4) make available, through loans, photographic or other copying procedures, or otherwise, such materials in the
p.000765: Library as the Secretary determines appropriate;
p.000765: (5) provide reference and research assistance;
p.000765: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000765:
p.000765:
p.000765:
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p.000765: Sec. 465 PUBLIC HEALTH SERVICE ACT 766
p.000765: (6) publicize the availability from the Library of the prod- ucts and services described in any of
p.000765: paragraphs (1) through (5);
p.000765: (7) promote the use of computers and telecommunications by health professionals (including health professionals
p.000765: in rural areas) for the purpose of improving access to biomedical infor- mation for health care delivery and medical
p.000765: research; and
p.000765: (8) engage in such other activities as the Secretary deter- mines appropriate and as the Library’s resources
p.000765: permit.
p.000765: (c) The Secretary may exchange, destroy, or otherwise dispose of any books, periodicals, films, and other
p.000765: library materials not needed for the permanent use of the Library.
p.000765: (d)(1) The Secretary may, after obtaining the advice and rec- ommendations of the Board of Regents, prescribe
p.000765: rules under which the Library will—
p.000765: (A) provide copies of its publications or materials,
p.000765: (B) will make available its facilities for research, or
p.000765: (C) will make available its bibliographic, reference, or other services,
p.000765: to public and private entities and individuals.
p.000765: (2) Rules prescribed under paragraph (1) may provide for mak- ing available such publications, materials, facilities,
p.000765: or services—
p.000765: (A) without charge as a public service,
p.000765: (B) upon a loan, exchange, or charge basis, or
p.000765: (C) in appropriate circumstances, under contract arrange- ments made with a public or other nonprofit entity.
p.000765: (e) Whenever the Secretary, with the advice of the Board of Re- gents, determines that—
p.000765: (1) in any geographic area of the United States there is no regional medical library adequate to serve such area;
p.000765: (2) under criteria prescribed for the administration of sec- tion 475, there is a need for a regional medical
p.000765: library to serve such area; and
p.000765: (3) because there is no medical library located in such area which, with financial assistance under section 475, can
p.000765: feasibly be developed into a regional medical library adequate to serve such area,
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p.000771:
p.000771:
p.000771:
p.000771: January 30, 2020
p.000771:
p.000771: and individual scientists for the purpose of supporting biomedical scientific publications of a nonprofit
p.000771: nature and to procure the com- pilation, writing, editing, and publication of reviews, abstracts, in- dices,
p.000771: handbooks, bibliographies, and related matter pertaining to scientific works and scientific developments.
p.000771: (b) Grants under subsection (a) in support of any single peri- odical publication may not be made for more
p.000771: than three years, ex- cept in those cases in which the Secretary determines that further support is necessary to carry
p.000771: out the purposes of subsection (a).
p.000771: GRANT PAYMENTS, RECORDS, AND AUDIT
p.000771: SEC. 477. ø286b–8¿ (a) Payments under grants made under sections 472, 473, 474, 475, and 476 may be
p.000771: made in advance or by way of reimbursement and in such installments as the Secretary shall prescribe by regulation
p.000771: after consultation with the Board.
p.000771: (b)(1) Each recipient of a grant under this subpart shall keep such records as the Secretary shall
p.000771: prescribe, including records which fully disclose the amount and disposition by such recipient of the
p.000771: proceeds of such grant, the total cost of the project or under- taking in connection with which such grant is
p.000771: given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources,
p.000771: and such other records as will facilitate an effective audit.
p.000771: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000771: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000771: records of such recipients that are pertinent to any grant received under this subpart.
p.000771: Subpart 3—National Center for Biotechnology Information
p.000771: PURPOSE, ESTABLISHMENT, FUNCTIONS, AND FUNDING OF THE NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION
p.000771: SEC. 478. ø286c¿ (a) In order to focus and expand the collec- tion, storage, retrieval, and
p.000771: dissemination of the results of bio- technology research by information systems, and to support and en- hance the
p.000771: development of new information technologies to aid in the understanding of the molecular processes that
p.000771: control health and disease, there is established the National Center for Bio- technology Information
p.000771: (hereinafter in this section referred to as the ‘‘Center’’) in the National Library of Medicine.
p.000771: (b) The Secretary, through the Center and subject to section 465(d), shall—
p.000771: (1) design, develop, implement, and manage automated systems for the collection, storage, retrieval, analysis,
p.000771: and dis- semination of knowledge concerning human molecular biology, biochemistry, and genetics;
p.000771: (2) perform research into advanced methods of computer- based information processing capable of representing and
p.000771: ana- lyzing the vast number of biologically important molecules and compounds;
p.000771: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000771:
p.000771:
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p.000771:
p.000771:
p.000773: 773
p.000773: PUBLIC HEALTH SERVICE ACT
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p.000801: plishments in biomedical or behavioral research.
p.000801: (D) The term of service as a member of an ethics board shall be for the life of the board. If such
p.000801: a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy
p.000801: shall be appointed for the remainder of the term of the predecessor of the in- dividual.
p.000801: (E) A member of an ethics board shall be subject to re- moval from the board by the Secretary for neglect of duty or
p.000801: malfeasance or for other good cause shown.
p.000801: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000801:
p.000801:
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p.000801: Sec. 492B PUBLIC HEALTH SERVICE ACT 802
p.000801:
p.000801: (F) The Secretary shall designate an individual from among the members of an ethics board to serve as
p.000801: the chair of the board.
p.000801: (G) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquir-
p.000801: ies and hold public hearings.
p.000801: (H) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall have
p.000801: access to all relevant information possessed by the Department of Health and Human Services, or available to
p.000801: the Secretary from other agencies.
p.000801: (I) Members of an ethics board shall receive compensa- tion for each day engaged in carrying out the duties of the
p.000801: board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an
p.000801: amount in excess of the maximum rate of basic pay pay- able for GS–18 of the General Schedule.
p.000801: (J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to
p.000801: each ethics board reasonable staff and assistance to carry out the du- ties of the board.
p.000801: (K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph
p.000801: (B)(ii) is submitted to the Secretary and the congressional com- mittees specified in such subparagraph.
p.000801: (6) DEFINITION.—For purposes of this subsection, the term ‘‘ethical considerations’’ means considerations as to
p.000801: whether the nature of the research involved is such that it is unethical to conduct or support the research.
p.000801:
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p.000801:
p.000801: January 30, 2020
p.000801: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH
p.000801: SEC. 492B. ø289a–2¿ (a) REQUIREMENT OF INCLUSION.—
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p.000815: (5) other activities to advance the goals of the Initiative, as the Secretary determines appropriate.
p.000815: (c) AUTHORITY OF THE SECRETARY.—In carrying out this sec- tion, the Secretary may—
p.000815: (1) coordinate with the Secretary of Energy, private indus- try, and others, as the Secretary determines
p.000815: appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the
p.000815: Initiative;
p.000815: (2) develop and utilize public-private partnerships; and
p.000815: (3) leverage existing data sources.
p.000815: (d) REQUIREMENTS.—In the implementation of the Initiative under subsection (a), the Secretary shall—
p.000815: (1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, the
p.000815: Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of
p.000815: the Department of Health and Human Services;
p.000815: (2) comply with existing laws and regulations for the pro- tection of human subjects involved in
p.000815: research, including the protection of participant privacy;
p.000815: (3) implement policies and mechanisms for appropriate se- cure data sharing across systems that include
p.000815: protections for privacy and security of data;
p.000815: (4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration
p.000815: of bio- logical, social, and other determinants of health that contribute to health disparities;
p.000815: (5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological
p.000815: material and as- sociated information collected or stored in connection with the Initiative; and
p.000815: (6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities
p.000815: with ac- cess to such information and provide information with respect to the purpose of such access, a
p.000815: summary of the research project for which such access is granted, as applicable, and a description of
p.000815: the biological material and associated informa- tion to which the entity has access.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000815:
p.000815:
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p.000815:
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p.000817: PUBLIC HEALTH SERVICE ACT
p.000817: Sec. 499
p.000817:
p.000817: (e) REPORT.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall submit
p.000817: a report on the relevant data access policies and procedures to the Com- mittee on Health, Education,
p.000817: Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives.
p.000817: Such report shall include steps the Secretary has taken to consult with experts or other heads of
p.000817: departments or agencies of the Federal Government in the development of such policies.
p.000817:
p.000817: PART I—FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH
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p.000817: January 30, 2020
p.000817: SEC. 499. ø290b¿ ESTABLISHMENT AND DUTIES OF FOUNDATION.
p.000817: (a) IN GENERAL.—The Secretary shall, acting through the Di- rector of NIH, establish a nonprofit corporation to
p.000817: be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the
p.000817: ‘‘Foundation’’). The Foundation shall not be an agency or instrumentality of the United States Government.
p.000817: (b) PURPOSE OF FOUNDATION.—The purpose of the Foundation shall be to support the National Institutes of Health
p.000817: in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with
p.000817: biomedical researchers from uni- versities, industry, and nonprofit organizations.
p.000817: (c) CERTAIN ACTIVITIES OF FOUNDATION.—
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p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
p.000827: evaluating service pro- grams for the prevention and treatment of alcoholism and alco- hol abuse within the
p.000827: Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center for Mental Health
p.000827: Services, and coordinating such programs among the Centers, and among the Centers and other public
p.000827: and private entities. The Associate Administrator also may en- sure that alcohol prevention, education, and
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p.000855: PUBLIC HEALTH SERVICE ACT
p.000855: Sec. 509
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p.000855: January 30, 2020
p.000855: (B) REPORT.—The Director of the Center for Behav- ioral Health Statistics and Quality, in coordination
p.000855: with the Director of the Center for Substance Abuse Treatment shall submit to the relevant committees of
p.000855: jurisdiction of the House of Representatives and the Senate a report on the evaluation under subparagraph
p.000855: (A). The report shall include, at a minimum—
p.000855: (i) outcomes information from the pilot program, including any resulting reductions in the use of alcohol and
p.000855: other drugs;
p.000855: (ii) engagement in treatment services;
p.000855: (iii) retention in the appropriate level and dura- tion of services;
p.000855: (iv) increased access to the use of medications ap- proved by the Food and Drug Administration for the
p.000855: treatment of substance use disorders in combination with counseling; and
p.000855: (v) other appropriate measures.
p.000855: (C) RECOMMENDATION.—The report under subpara- graph (B) shall include a recommendation by the Director
p.000855: of the Center for Substance Abuse Treatment as to wheth- er the pilot program under this subsection should be
p.000855: ex- tended.
p.000855: (6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For pur- poses of this subsection, the term ‘‘State substance abuse
p.000855: agen- cy’’ means, with respect to a State, the agency in such State that manages the Substance Abuse
p.000855: Prevention and Treatment Block Grant under part B of title XIX.
p.000855: (s) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000855: to be appropriated
p.000855: $29,931,000 for each of fiscal years 2019 through 2023. Of the amounts made available for a year
p.000855: pursuant to theprevious sen- tence to carry out this section, not more than25 percent of such amounts
p.000855: shall be made available for suchyear to carry out sub- section (r), other than paragraph (5) ofsuch
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p.000859: 859
p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000859: January 30, 2020
p.000859: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or cooperative agreement, a plan for the evaluation of any
p.000859: project undertaken with funds provided under this section. Such entity shall provide the Secretary with
p.000859: periodic evaluations of the progress of such project and such eval- uation at the completion of such
p.000859: project as the Secretary deter- mines to be appropriate.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000859: $29,605,000 for each of fiscal years 2018 through 2022.
p.000859: øSection 514A was repealed by section 9017 of Public Law 114–255.¿
p.000859: SEC. 514B. ø290bb–10¿ EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND INTERVENTIONS DEMONSTRA-
p.000859: TION.
p.000859: (a) GRANTS TO EXPAND ACCESS.—
p.000859: (1) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements to
p.000859: State substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes and tribal
p.000859: organizations (as defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act) that have
p.000859: a high rate, or have had a rapid increase, in the use of heroin or other opioids, in order to permit
p.000859: such entities to expand activities, including an ex- pansion in the availability of evidence-based
p.000859: medication-as- sisted treatment and other clinically appropriate services, with respect to the treatment of
p.000859: addiction in the specific geo- graphical areas of such entities where there is a high rate or rapid
p.000859: increase in the use of heroin or other opioids, such as in rural areas.
p.000859: (2) NATURE OF ACTIVITIES.—Funds awarded under para- graph (1) shall be used for activities that are based on
p.000859: reliable scientific evidence of efficacy in the treatment of problems re- lated to heroin or other opioids.
p.000859: (b) APPLICATION.—To be eligible for a grant, contract, or coop- erative agreement under subsection (a),
p.000859: an entity shall submit an application to the Secretary at such time, in such manner, and ac- companied by such
p.000859: information as the Secretary may reasonably require.
p.000859: (c) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
...

p.000863: (2) The Secretary of Health and Human Services shall con- tinue to conduct research and collect data on the
p.000863: short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ
p.000863: systems.
p.000863: (3) States and communities, including colleges and univer- sities, are encouraged to adopt comprehensive
p.000863: prevention ap- proaches, including—
p.000863: (A) evidence-based screening, programs and curricula;
p.000863: (B) brief intervention strategies;
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: Sec. 519B PUBLIC HEALTH SERVICE ACT 864
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p.000863: January 30, 2020
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p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
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p.000865: (II) the extent of progress in preventing and reducing underage drinking nationally;
p.000865: (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
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p.000865: January 30, 2020
p.000865: (IV) such other information regarding under- age drinking as the Secretary determines to be ap- propriate.
p.000865: (ii) CERTAIN INFORMATION.—The report under clause (i) shall include information on the following:
p.000865: (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not
p.000865: limited to Monitoring the Future, Youth Risk Behavior Surveillance System, the Na- tional Survey on Drug
p.000865: Use and Health, and the Fatality Analysis Reporting System.
p.000865: (II) Measures of the availability of alcohol from commercial and non-commercial sources to underage
p.000865: populations.
p.000865: (III) Measures of the exposure of underage populations to messages regarding alcohol in ad- vertising and
p.000865: the entertainment media as re- ported by the Federal Trade Commission.
p.000865: (IV) Surveillance data, including information on the onset and prevalence of underage drinking, consumption
p.000865: patterns and the means of underage access. The Secretary shall develop a plan to im- prove the collection,
p.000865: measurement and consistency of reporting Federal underage alcohol data.
p.000865: (V) Any additional findings resulting from re- search conducted or supported under subsection (f).
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: Sec. 519B PUBLIC HEALTH SERVICE ACT 866
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p.000865: January 30, 2020
p.000865:
p.000865: (VI) Evidence-based best practices to prevent and reduce underage drinking and provide treat- ment services
p.000865: to those youth who need them.
p.000865: (2) ANNUAL REPORT ON STATE UNDERAGE DRINKING PRE- VENTION AND ENFORCEMENT ACTIVITIES.—
p.000865: (A) IN GENERAL.—The Secretary shall, with input and collaboration from other appropriate Federal agencies,
p.000865: States, Indian tribes, territories, and public health, con- sumer, and alcohol beverage industry groups,
p.000865: annually issue a report on each State’s performance in enacting, en- forcing, and creating laws, regulations, and
p.000865: programs to prevent or reduce underage drinking.
p.000865: (B) STATE PERFORMANCE MEASURES.—
p.000865: (i) IN GENERAL.—The Secretary shall develop, in consultation with the Committee, a set of measures to be used in
p.000865: preparing the report on best practices.
p.000865: (ii) CATEGORIES.—In developing these measures, the Secretary shall consider categories including, but not
p.000865: limited to:
p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
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p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
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p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
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p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
p.000883: (e) CONDITION.—An applicant for a grant or cooperative agree- ment under subsection (a) shall demonstrate to the
p.000883: Secretary that the application complies with the State-sponsored statewide early intervention and prevention
p.000883: strategy as developed under section 520E and the applicant has the support of the local community and relevant
p.000883: public health officials.
p.000883: (f) SPECIAL POPULATIONS.—In awarding grants and cooperative agreements under subsection (a), the Secretary shall
p.000883: ensure that such awards are made in a manner that will focus on the needs of communities or groups
p.000883: that experience high or rapidly rising rates of suicide.
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p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
p.000887: (1) A description of the population to be targeted by the program carried out under the grant, including
p.000887: veterans when- ever possible and appropriate, and of identified mental and substance use disorder needs of
p.000887: students at the institution of higher education.
p.000887: (2) A description of Federal, State, local, private, and insti- tutional resources currently available to address the
p.000887: needs de- scribed in paragraph (1) at the institution of higher education, which may include, as appropriate and in
p.000887: accordance with sub- section (b)(7), a plan to seek input from relevant stakeholders in the community,
p.000887: including appropriate public and private en- tities, in order to carry out the program under the grant.
p.000887: (3) A description of the outreach strategies of the institu- tion of higher education for promoting
p.000887: access to services, in- cluding a proposed plan for reaching those students most in need of mental health
p.000887: services.
p.000887: (4) A plan to evaluate program outcomes, including a de- scription of the proposed use of funds, the
p.000887: program objectives, and how the objectives will be met.
p.000887: (5) An assurance that the institution will submit a report to the Secretary each fiscal year on the
p.000887: activities carried out with the grant and the results achieved through those activi- ties.
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p.000887: (6) An outline of the objectives of the program carried out under the grant.
p.000887: (7) For an institution of higher education proposing to use the grant for an activity described in paragraph
p.000887: (8) or (9) of subsection (b), a description of the policies and procedures of the institution of higher
p.000887: education that are related to applica- ble laws regarding access to, and sharing of, treatment records of students
p.000887: at any campus-based mental health center or part- ner organization, including the policies and State laws gov-
p.000887: erning when such records can be accessed and shared for non- treatment purposes and a description of the process
p.000887: used by the institution of higher education to notify students of these policies and procedures,
p.000887: including the extent to which written consent is required.
p.000887: (8) An assurance that grant funds will be used to supple- ment and not supplant any other Federal, State, or
p.000887: local funds available to carry out activities of the type carried out under the grant.
p.000887: (e) REQUIREMENT OF MATCHING FUNDS.—
p.000887: (1) IN GENERAL.—The Secretary may make a grant under this section to an institution of higher education only if
p.000887: the in- stitution agrees to make available (directly or through dona- tions from public or private entities)
p.000887: non-Federal contributions
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: Sec. 520E–3 PUBLIC HEALTH SERVICE ACT 888
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p.000887: in an amount that is not less than $1 for each $1 of Federal funds provided in the grant, toward the costs
p.000887: of activities car- ried out with the grant (as described in subsection (b)) and other activities by the
p.000887: institution to reduce student mental health and substance use disorders.
p.000887: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required under paragraph (1) may be in cash
p.000887: or in kind. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
p.000887: extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.000887: contributions.
p.000887: (3) WAIVER.—The Secretary may waive the requirement established in paragraph (1) with respect to an
p.000887: institution of higher education if the Secretary determines that extraor- dinary need at the institution
p.000887: justifies the waiver.
p.000887: (f) REPORTS.—For each fiscal year that grants are awarded under this section, the Secretary shall conduct
p.000887: a study on the re- sults of the grants and submit to the Congress a report on such re- sults that includes the
p.000887: following:
p.000887: (1) An evaluation of the grant program outcomes, includ- ing a summary of activities carried out with the grant
p.000887: and the results achieved through those activities.
p.000887: (2) Recommendations on how to improve access to mental health and substance use disorder services at
p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
p.000887: (g) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000887: section 101 of the Higher Education Act of 1965.
p.000887: (h) TECHNICAL ASSISTANCE.—The Secretary may provide tech- nical assistance to grantees in carrying out this
p.000887: section.
p.000887: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000887: to be appropriated
p.000887: $7,000,000 for each of fiscal years 2018 through 2022.
p.000887: SEC. 520E–3. ø290bb–36c¿ NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.000887: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Suicide
p.000887: Prevention Lifeline program (referred to in this section as the ‘‘program’’), authorized under section 520A
p.000887: and in effect prior to the date of enactment of the Helping Families in Mental Health Crisis Reform Act of
p.000887: 2016.
p.000887: (b) ACTIVITIES.—In maintaining the program, the activities of the Secretary shall include—
p.000887: (1) coordinating a network of crisis centers across the United States for providing suicide prevention and
p.000887: crisis inter- vention services to individuals seeking help at any time, day or night;
p.000887: (2) maintaining a suicide prevention hotline to link callers to local emergency, mental health, and social
p.000887: services re- sources; and
p.000887: (3) consulting with the Secretary of Veterans Affairs to en- sure that veterans calling the suicide prevention
p.000887: hotline have access to a specialized veterans’ suicide prevention hotline.
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000887:
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p.000889: PUBLIC HEALTH SERVICE ACT
p.000889: Sec. 520F
p.000889:
p.000889: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $7,198,000
p.000889: for each of fiscal years 2018 through 2022.
p.000889: SEC. 520E–4. ø290bb-36d¿ TREATMENT REFERRAL ROUTING SERVICE.
p.000889: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Treatment
p.000889: Referral Routing Service (referred to in this section as the ‘‘Routing Service’’) to as- sist individuals and
p.000889: families in locating mental and substance use disorders treatment providers.
p.000889: (b) ACTIVITIES OF THE SECRETARY.—To maintain the Routing Service, the activities of the Assistant
p.000889: Secretary shall include ad- ministering—
p.000889: (1) a nationwide, telephone number providing year-round access to information that is updated on a
p.000889: regular basis re- garding local behavioral health providers and community- based organizations in a
p.000889: manner that is confidential, without requiring individuals to identify themselves, is in languages that
p.000889: include at least English and Spanish, and is at no cost to the individual using the Routing Service; and
p.000889: (2) an Internet website to provide a searchable, online treatment services locator of behavioral health
p.000889: treatment pro- viders and community-based organizations, which shall include information on the name, location,
p.000889: contact information, and basic services provided by such providers and organizations.
p.000889: (c) REMOVING PRACTITIONER CONTACT INFORMATION.—In the event that the Internet website described in
p.000889: subsection (b)(2) con- tains information on any qualified practitioner that is certified to prescribe
p.000889: medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act, the
p.000889: Assistant Sec- retary—
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p.000889: (1) shall provide an opportunity to such practitioner to have the contact information of the practitioner
p.000889: removed from the website at the request of the practitioner; and
p.000889: (2) may evaluate other methods to periodically update the information displayed on such website.
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p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
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p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000897: Sec. 520L PUBLIC HEALTH SERVICE ACT 898
p.000897:
p.000897: els;
p.000897: (A) development and selection of integrated care mod-
p.000897: (B) dissemination of evidence-based interventions in
p.000897: integrated care;
p.000897: (C) establishment of organizational practices to sup- port operational and administrative success; and
p.000897: (D) other activities, as the Secretary determines ap- propriate.
p.000897: (2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA- TION.—The information and resources provided by the
p.000897: Sec- retary under paragraph (1) shall, as appropriate, be made available to States, political
p.000897: subdivisions of States, Indian tribes or tribal organizations (as defined in section 4 of the In- dian
p.000897: Self-Determination and Education Assistance Act), out- patient mental health and addiction treatment
p.000897: centers, com- munity mental health centers that meet the criteria under sec- tion 1913(c), certified community
p.000897: behavioral health clinics de- scribed in section 223 of the Protecting Access to Medicare Act of 2014, primary care
p.000897: organizations such as Federally qualified health centers or rural health clinics as defined in section
p.000897: 1861(aa) of the Social Security Act, other community-based or- ganizations, or other entities engaging in
p.000897: integrated care ac- tivities, as the Secretary determines appropriate.
p.000897: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
p.000897: tion, there are authorized to be appropriated $51,878,000 for each of fiscal years 2018 through 2022.
p.000897: SEC. 520L. ø290bb–43¿ ADULT SUICIDE PREVENTION.
p.000897: (a) GRANTS.—
p.000897: (1) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities described in
p.000897: paragraph (2) to imple- ment suicide prevention and intervention programs, for indi- viduals who are 25
p.000897: years of age or older, that are designed to raise awareness of suicide, establish referral processes, and im-
p.000897: prove care and outcomes for such individuals who are at risk of suicide.
p.000897: (2) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a
p.000897: community-based pri- mary care or behavioral health care setting, an emergency de- partment, a State mental health
p.000897: agency (or State health agen- cy with mental or behavioral health functions), public health agency, a
p.000897: territory of the United States, or an Indian tribe or tribal organization (as the terms ‘‘Indian tribe’’
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p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
p.000911: to this subsection, the Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of
p.000911: Health and Human Services in order to achieve the maximum possible coordination of the regu- lations, and the
p.000911: implementation thereof, which they each prescribe.
p.000911: SEC. 543A. ø290dd–2a¿ PROMOTING ACCESS TO INFORMATION ON EVI- DENCE-BASED PROGRAMS AND PRACTICES.
p.000911: (a) IN GENERAL.—The Assistant Secretary shall, as appro- priate, improve access to reliable and valid
p.000911: information on evi- dence-based programs and practices, including information on the strength of evidence
p.000911: associated with such programs and practices, related to mental and substance use disorders for States, local com-
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: Sec. 544 PUBLIC HEALTH SERVICE ACT 912
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p.000911: munities, nonprofit entities, and other stakeholders, by posting on the Internet website of the Administration
p.000911: information on evidence- based programs and practices that have been reviewed by the As- sistant Secretary
p.000911: in accordance with the requirements of this sec- tion.
p.000911: (b) APPLICATIONS.—
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p.000911: provide for the public notice of such application period in the Federal Register. Such notice may solicit
p.000911: applications for evidence-based pro- grams and practices to address gaps in information identified by the
p.000911: Assistant Secretary, the National Mental Health and Substance Use Policy Laboratory established under
p.000911: section 501A, or the Assistant Secretary for Planning and Evaluation, including pursuant to the evaluation and
p.000911: recommendations under section 6021 of the Helping Families in Mental Health Crisis Reform Act of 2016 or
p.000911: priorities identified in the stra- tegic plan under section 501(l).
p.000911: (c) REQUIREMENTS.—The Assistant Secretary may establish minimum requirements for the applications
p.000911: submitted under sub- section (b), including applications related to the submission of re- search and
p.000911: evaluation.
p.000911: (d) REVIEW AND RATING.—
p.000911: (1) IN GENERAL.—The Assistant Secretary shall review ap- plications prior to public posting in accordance with
p.000911: subsection (a), and may prioritize the review of applications for evidence- based programs and practices that are
p.000911: related to topics in- cluded in the notice provided under subsection (b)(2).
p.000911: (2) SYSTEM.—In carrying out paragraph (1), the Assistant Secretary may utilize a rating and review
p.000911: system, which may include information on the strength of evidence associated with the evidence-based programs and
p.000911: practices and a rating of the methodological rigor of the research supporting the applica- tions.
p.000911: (3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant Secretary shall make the metrics used to evaluate
p.000911: applications under this section, and any resulting ratings of such applica- tions, publicly available.
p.000911: SEC. 544. ø290dd–3¿ GRANTS FOR REDUCING OVERDOSE DEATHS.
p.000911: (a) ESTABLISHMENT.—
p.000911: (1) IN GENERAL.—The Secretary shall award grants to eli- gible entities to expand access to drugs or devices
p.000911: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000911: suspected opioid overdose.
p.000911: (2) MAXIMUM GRANT AMOUNT.—A grant awarded under this section may not be for more than $200,000 per grant year.
p.000911: (3) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a Federally qualified
p.000911: health center (as defined in section 1861(aa) of the Social Security Act), an
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p.000913: PUBLIC HEALTH SERVICE ACT
p.000913: Sec. 544
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p.000913: ing medication-assisted treatment and appropriate counseling and behavioral therapies.
p.000913: (d) EVALUATIONS BY RECIPIENTS.—As a condition of receipt of a grant under this section, an eligible
p.000913: entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities
p.000913: funded by the grant which contains such information as the Secretary may reasonably require.
p.000913: (e) REPORTS BY THE SECRETARY.—Not later than 5 years after the date on which the first grant under this
p.000913: section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of
p.000913: the Senate a report aggregating the in- formation received from the grant recipients for such year under
p.000913: subsection (d) and evaluating the outcomes achieved by the pro- grams funded by grants awarded under this
p.000913: section.
p.000913: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section, $5,000,000 for
p.000913: the period of fiscal years 2017 through 2021.
p.000913: SEC. 545. ø290ee¿ OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION GRANT PROGRAMS.
p.000913: (a) GRANTS TO STATES.—The Secretary shall make grants to States to—
p.000913: (1) implement strategies for pharmacists to dispense a drug or device approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, as
p.000913: appropriate, pursuant to a stand- ing order;
p.000913: (2) encourage pharmacies to dispense opioid overdose re- versal medication pursuant to a standing order;
p.000913: (3) develop or provide training materials that persons au- thorized to prescribe or dispense a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose may use to educate the public concerning—
p.000913: (A) when and how to safely administer such drug or device; and
p.000913: (B) steps to be taken after administering such drug or device; and
p.000913: (4) educate the public concerning the availability of drugs or devices approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose without
...

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p.000919: January 30, 2020
p.000919:
p.000919: (2) PURPOSES.—A State receiving a grant under this sec- tion shall establish a comprehensive response
p.000919: plan to opioid abuse, which may include—
p.000919: (A) education efforts around opioid use, treatment, and addiction recovery, including education of residents,
p.000919: med- ical students, and physicians and other prescribers of schedule II, III, or IV controlled
p.000919: substances on relevant prescribing guidelines, the prescription drug monitoring program of the State
p.000919: described in subparagraph (B), and overdose prevention methods;
p.000919: (B) establishing, maintaining, or improving a com- prehensive prescription drug monitoring program to track
p.000919: dispensing of schedule II, III, or IV controlled substances, which may—
p.000919: (i) provide for data sharing with other States; and
p.000919: (ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled
p.000919: substances to access the prescription drug monitoring program of the State;
p.000919: (C) developing, implementing, or expanding prescrip- tion drug and opioid addiction treatment programs by—
p.000919: (i) expanding the availability of treatment for pre- scription drug and opioid addiction, including medica-
p.000919: tion-assisted treatment and behavioral health therapy, as appropriate;
p.000919: (ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug
p.000919: and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically ap-
p.000919: propriate; or
p.000919: (iii) developing, implementing, or expanding recov- ery support services and programs at high schools or
p.000919: institutions of higher education;
p.000919: (D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to
p.000919: prescription medications and opioids; and
p.000919: (E) advancing the education and awareness of the pub- lic, providers, patients, consumers, and other appropriate
...

p.000923: identify and report fraudulent recovery housing operators.
p.000923: (B) FACTORS TO BE CONSIDERED.—In carrying out the activities described in paragraph (1), the Secretary
p.000923: shall identify or develop indicators, which may include indica- tors related to—
p.000923: (i) unusual billing practices;
p.000923: (ii) average lengths of stays;
p.000923: (iii) excessive levels of drug testing (in terms of cost or frequency); and
p.000923: (iv) unusually high levels of recidivism.
p.000923: (c) DISSEMINATION.—The Secretary shall, as appropriate, dis- seminate the best practices identified or
p.000923: developed under sub- section (a) and the common indicators identified or developed under subsection (b) to—
p.000923: (1) State agencies, which may include the provision of technical assistance to State agencies seeking to
p.000923: adopt or im- plement such best practices;
p.000923: (2) Indian tribes, tribal organizations, and tribally des- ignated housing entities;
p.000923: (3) the Attorney General of the United States;
p.000923: (4) the Secretary of Labor;
p.000923: (5) the Secretary of Housing and Urban Development;
p.000923: (6) State and local law enforcement agencies;
p.000923: (7) health insurance issuers;
p.000923: (8) recovery housing entities; and
p.000923: (9) the public.
p.000923: (d) REQUIREMENTS.—In carrying out the activities described in subsections (a) and (b), the Secretary, in
p.000923: consultation with appro- priate individuals and entities described in subsections (a)(2) and (b)(2), shall
p.000923: consider how recovery housing is able to support recov- ery and prevent relapse, recidivism, or overdose (including
p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000923:
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p.000925: 925
p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
...

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p.000927:
p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
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p.000927: January 30, 2020
p.000927:
p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
...

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p.000931: January 30, 2020
p.000931: (A) Non-Federal contributions required in paragraph
p.000931: (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts
p.000931: provided by the Federal Government, or services assisted or subsidized to any significant extent by the
p.000931: Federal Government, may not be included in determining the amount of such non- Federal contributions.
p.000931: (B) In making a determination of the amount of non- Federal contributions for purposes of subparagraph
p.000931: (A), the Secretary may include only non-Federal contributions in excess of the average amount of
p.000931: non-Federal contribu- tions made by the public entity involved toward the pur- pose described in
p.000931: subsection (a) for the 2-year period pre- ceding the first fiscal year for which the entity receives a
p.000931: grant under such section.
p.000931: SEC. 562. ø290ff–1¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.000931: (a) SYSTEMS OF COMPREHENSIVE CARE.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that, with respect to children
p.000931: with a serious emotional disturbance, the public entity involved will carry out the purpose described in such section
p.000931: only through establishing and operating 1 or more systems of care for making each of the mental health services
p.000931: specified in subsection (c) available to each child provided access to the system. In providing for such a system,
p.000931: the public entity may make grants to, and enter into contracts with, public and nonprofit private entities.
p.000931: (2) STRUCTURE OF SYSTEM.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000931: para- graph (1) will—
p.000931: (A) be established in a community selected by the pub- lic entity involved;
p.000931: (B) consist of such public agencies and nonprofit pri- vate entities in the community as are necessary to
p.000931: ensure that each of the services specified in subsection (c) is avail- able to each child provided access to the
p.000931: system;
p.000931: (C) be established pursuant to agreements that the public entity enters into with the agencies and entities de-
p.000931: scribed in subparagraph (B);
p.000931: (D) coordinate the provision of the services of the sys- tem; and
p.000931: (E) establish an office whose functions are to serve as the location through which children are provided access to the
p.000931: system, to coordinate the provision of services of the system, and to provide information to the public
p.000931: regarding the system.
p.000931: (3) COLLABORATION OF LOCAL PUBLIC ENTITIES.—A funding agreement for a grant under section 561(a) is that,
p.000931: for pur- poses of the establishment and operation of a system of care under paragraph (1), the public
p.000931: entity involved will seek col- laboration among all public agencies that provide human serv- ices in the
p.000931: community in which the system is established, in- cluding but not limited to those providing mental
p.000931: health serv-
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000931:
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p.000931:
p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: January 30, 2020
p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
p.000931: provider involved to each child provided access to the system; and
p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
p.000931: (2) SPECIFICATION OF NON-MENTAL HEALTH SERVICES.—The providers referred to in paragraph (1) are providers of
p.000931: medical services other than mental health services, providers of edu- cational services, providers of
p.000931: vocational counseling and voca- tional rehabilitation services, and providers of protection and advocacy
p.000931: services with respect to mental health.
p.000931: (3) FACILITATION OF SERVICES OF CERTAIN PROGRAMS.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will, for purposes of para- graph (1), enter into a
p.000931: memorandum of understanding regard- ing facilitation of—
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: 933
p.000933: PUBLIC HEALTH SERVICE ACT
p.000933: Sec. 562
p.000933:
p.000933: (A) services available pursuant to title XIX of the So- cial Security Act, including services regarding
p.000933: early peri- odic screening, diagnosis, and treatment;
p.000933: (B) services available under parts B and C of the Indi- viduals with Disabilities Education Act; and
p.000933: (C) services available under other appropriate pro- grams, as identified by the Secretary.
p.000933: (e) GENERAL PROVISIONS REGARDING SERVICES OF SYSTEM.—
p.000933: (1) CASE MANAGEMENT SERVICES.—A funding agreement for a grant under section 561(a) is that a system of care
p.000933: under subsection (a) will provide for the case management of each child provided access to the system in
p.000933: order to ensure that—
p.000933: (A) the services provided through the system to the child are coordinated and that the need of each such child
p.000933: for the services is periodically reassessed;
p.000933: (B) information is provided to the family of the child on the extent of progress being made toward the
p.000933: objectives established for the child under the plan of services imple- mented for the child pursuant to
p.000933: section 563; and
p.000933: (C) the system provides assistance with respect to—
p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
p.000933:
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p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
p.000933: (B) with respect to subparagraph (D) of such para- graph, to authorize the system of care to expend the grant
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p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
p.000933: (b) MULTIDISCIPLINARY TEAM.—A funding agreement for a grant under section 561(a) is that the plan
p.000933: required in subsection
p.000933: (a) will be developed, and reviewed and as appropriate revised not less than once each year, by a
p.000933: multidisciplinary team of appro- priately qualified individuals who provide services through the sys- tem,
p.000933: including as appropriate mental health services, other health
p.000933:
p.000933: January 30, 2020 As Amended Through P.L. 116-94,
p.000933: Enacted December 20, 2019
p.000933:
p.000933:
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p.000933:
p.000935: 935
p.000935: PUBLIC HEALTH SERVICE ACT
p.000935: Sec. 564
p.000935:
p.000935: services, educational services, social services, and vocational coun- seling and rehabilitation; 16
p.000935: (c) COORDINATION WITH SERVICES UNDER INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—A funding agreement
...

p.000935: (2) provide for each of such services that is appropriate to the circumstances of the child, including, except in the
p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
p.000935: day treat- ment under paragraph (5) of such section, and foster care or group homes under paragraph (7)
p.000935: of such section; and
p.000935: (C) the development of individualized plans for pur- poses of section 563;
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p.000935: January 30, 2020
p.000935: 16 So in law. See section 119 of Public Law 102–321 (106 Stat. 349). Probably should be a pe- riod.
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000935: Sec. 564 PUBLIC HEALTH SERVICE ACT 936
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p.000935: (3) recreational activities for children provided access to the system; and
p.000935: (4) such other services as may be appropriate in providing for the comprehensive needs with respect to mental
p.000935: health of children with a serious emotional disturbance.
p.000935: (b) COMPREHENSIVE PLAN.—The Secretary may make a grant under section 561(a) only if, with respect to the
p.000935: jurisdiction of the public entity involved, the entity has submitted to the Secretary, and has had approved
p.000935: by the Secretary, a plan for the development of a jurisdiction-wide system of care for community-based services
p.000935: for children with a serious emotional disturbance that specifies the progress the public entity has made in developing
p.000935: the jurisdiction- wide system, the extent of cooperation across agencies serving chil- dren in the establishment of the
p.000935: system, the Federal and non-Fed- eral resources currently committed to the establishment of the sys- tem, and the
p.000935: current gaps in community services and the manner in which the grant under section 561(a) will be
p.000935: expended to ad- dress such gaps and establish local systems of care.
p.000935: (c) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—A fund- ing agreement for a grant under section 561(a) is
p.000935: that, if a charge is imposed for the provision of services under the grant, such charge—
p.000935: (1) will be made according to a schedule of charges that is made available to the public;
p.000935: (2) will be adjusted to reflect the income of the family of the child involved; and
...

p.000935: percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised
p.000935: by the Secretary in ac- cordance with section 673(2) of the Omnibus Budget Reconcili- ation Act of 1981.
p.000935: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A funding agreement for a grant under
p.000935: section 561(a) is that the grant, and the non-Federal contributions made with re- spect to the grant,
p.000935: will not be expended to make payment for any item or service to the extent that payment has been
p.000935: made, or can reasonably be expected to be made, with respect to such item or service—
p.000935: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000935: health benefits program; or
p.000935: (2) by an entity that provides health services on a prepaid basis.
p.000935: (e) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 561(a) is
p.000935: that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
p.000935: grant by the public entity involved.
p.000935: (f) REPORTS TO SECRETARY.—A funding agreement for a grant under section 561(a) is that the public entity
p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
p.000935: provided access to systems of care operated pursuant to the grant, the demographic
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: 937
p.000937: PUBLIC HEALTH SERVICE ACT
p.000937: Sec. 565
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p.000937: characteristics of the children, the types and costs of services pro- vided pursuant to the grant, the
p.000937: availability and use of third-party reimbursements, estimates of the unmet need for such services in the
p.000937: jurisdiction of the entity, and the manner in which the grant has been expended toward the establishment of a
p.000937: jurisdiction-wide system of care for children with a serious emotional disturbance, and such other
p.000937: information as the Secretary may require with re- spect to the grant.
...

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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
...

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p.000957:
p.000957: tenance and operation make possible, in the order of such rel- ative need;
p.000957: (7) provide minimum standards (to be fixed in the discre- tion of the State) for the maintenance and
p.000957: operation of facili- ties providing inpatient care which receive aid under this part and, effective July 1, 1966,
p.000957: provide for enforcement of such standards with respect to projects approved by the Surgeon General under
p.000957: this part after June 30, 1964;
p.000957: (8) provide such methods of administration of the State plan, including methods relating to the
p.000957: establishment and maintenance of personnel standards on a merit basis (except that the Surgeon General
p.000957: shall exercise no authority with re- spect to the selection, tenure of office, or compensation of any
p.000957: individual employed in accordance with such methods), as are found by the Surgeon General to be
p.000957: necessary for the proper and efficient operation of the plan;
p.000957: (9) provide for affording to every applicant for a construc- tion or modernization project an opportunity
p.000957: for a hearing be- fore the State agency;
p.000957: (10) provide that the State agency will make such reports, in such form and containing such information, as the Surgeon
p.000957: General may from time to time reasonably require, and will keep such records and afford such access
p.000957: thereto as the Sur- geon General may find necessary to assure the correctness and verification of such reports;
p.000957: (11) provide that the Comptroller General of the United States or his duly authorized representatives shall
p.000957: have access for the purpose of audit and examination to the records speci- fied in paragraph (10);
p.000957: (12) provide that the State agency will from time to time, but not less often than annually, review its State
p.000957: plan and sub- mit to the Surgeon General any modifications thereof which it considers necessary; and
p.000957: (13) effective July 1, 1971, provide that before any project for construction or modernization of any general hospital
p.000957: is ap- proved by the State agency there will be reasonable assurance of adequate provision for extended care services
p.000957: (as determined in accordance with regulations) to patients of such hospital when such services are
p.000957: medically appropriate for them, with such services being provided in facilities which (A) are struc-
p.000957: turally part of, physically connected with, or in immediate proximity to, such hospital, and (B) either (i) are
p.000957: under the su- pervision of the professional staff of such hospital or (ii) have organized medical staffs and
p.000957: have in effect transfer agreements with such hospital; except that the Secretary may, at the re- quest of the
p.000957: State agency, waive compliance with clause (A) or (B), or both such clauses, as the case may be, in the
p.000957: case of any project if the State agency has determined that compliance with such clause or clauses in such case would
p.000957: be inadvisable.
p.000957: (b) The Surgeon General shall approve any State plan and any modification thereof which complies with the
p.000957: provisions of sub- section (a). If any such plan or modification thereof shall have been disapproved by the Surgeon
p.000957: General for failure to comply with sub- section (a), the Federal Hospital Council shall, upon request of the
...

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p.000967: of the project and the amount of the loan for which a guarantee is sought under this part, or the
p.000967: amount of the direct loan sought under this part, as the case may be.
p.000967: (b) The Secretary may approve such application only if—
p.000967: (1) there remains sufficient balance in the allotment deter- mined for such State pursuant to section 622 to
p.000967: cover the amount of the loan for which a guarantee is sought, or the amount of the direct loan sought (as
p.000967: the case may be), in such application,
p.000967: (2) he makes each of the findings which are required by clauses (1) through (4) of section 605(b) for the
p.000967: approval of ap- plications for projects thereunder (except that, in the case of the finding required under
p.000967: such clause (4) of entitlement of a project to a priority established under section 603(a), such find- ing shall
p.000967: be made without regard to the provisions of clauses
p.000967: (1) and (3) of such section),
p.000967: (3) he finds that there is compliance with section 605(e),
p.000967: (4) he obtains assurances that the applicant will keep such records, and afford such access thereto, and make such
p.000967: reports, in such form and containing such information, as the Secretary may reasonably require, and
p.000967: (5) he also determines, in the case of a loan for which a guarantee is sought, that the terms, conditions,
p.000967: maturity, secu- rity (if any), and schedule and amounts of repayments with re- spect to the loan are sufficient to
p.000967: protect the financial interests of the United States and are otherwise reasonable and in ac- cord with
p.000967: regulations, including a determination that the rate of interest does not exceed such per centum per annum on the
p.000967: principal obligation outstanding as the Secretary determines to be reasonable, taking into account the range of
p.000967: interest rates prevailing in the private market for similar loans and the risks assumed by the United States.
p.000967: (c) No application under this section shall be disapproved until the Secretary has afforded the State agency an
p.000967: opportunity for a hearing.
p.000967: (d) Amendment of an approved application shall be subject to approval in the same manner as an original
p.000967: application.
p.000967: (e)(1) In the case of any loan to a nonprofit private agency, the United States shall be entitled to recover
p.000967: from the applicant the amount of any payments made pursuant to any guarantee of such loan under this part, unless
p.000967: the Secretary for good cause waives its right of recovery, and, upon making any such payment, the United States shall
p.000967: be subrogated to all of the rights of the recipient of the payments with respect to which the guarantee was made.
p.000967: (2) Guarantees of loans to nonprofit private agencies under this part shall be subject to such further terms
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
p.001011: (A) CONDITIONS.—The conditions specified in this sub- paragraph are that a designated health professions
p.001011: school—
p.001011: (i) is a school described in section 799B(1); and
p.001011: (ii) received a contract under section 788B for fis- cal year 1987, as such section was in effect for such
p.001011: fiscal year.
p.001011: (B) USE OF GRANT.—In addition to the purposes de- scribed in subsection (b), a grant under subsection
p.001011: (a) to a designated health professions school meeting the condi- tions described in subparagraph (A) may be
p.001011: expended—
p.001011: (i) to develop a plan to achieve institutional im- provements, including financial independence, to en-
p.001011: able the school to support programs of excellence in health professions education for under-represented mi-
p.001011: nority individuals; and
p.001011: (ii) to provide improved access to the library and informational resources of the school.
p.001011: (C) EXCEPTION.—The requirements of paragraph (1)(C) shall not apply to a historically black college or university that
p.001011: receives funding under paragraphs (2) or (5) 7.
p.001011: (3) HISPANIC CENTERS OF EXCELLENCE.—The conditions specified in this paragraph are that—
p.001011: (A) with respect to Hispanic individuals, each of clauses (i) through (iv) of paragraph (1)(B)
p.001011: applies to the designated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Hispanic individ- uals; and
p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit community based His- panic serving organizations, or public or nonprofit pri-
p.001011: vate institutions of higher education, including schools of nursing, whose enrollment of students has tradi-
p.001011: tionally included a significant number of Hispanic in- dividuals, the purposes of which will be to carry out a
p.001011: program—
p.001011: (I) to identify Hispanic students who are in- terested in a career in the health profession in- volved;
p.001011: and
p.001011:
p.001011:
p.001011:
p.001011: January 30, 2020
p.001011: 7 So in law. Probably should read ‘‘paragraph (2) or (5)’’.
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001011:
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p.001043: January 30, 2020
p.001043: (B) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001043: Secretary may require.
p.001043: (3) CONDITION OF AWARD.—As a condition of receiving an award under this subsection, an individual shall
p.001043: agree that, following completion of the award period, the individual will teach or practice in the field
p.001043: of geriatrics, long-term care, or chronic care management for a minimum of 5 years under guidelines set by
p.001043: the Secretary.
p.001043: (4) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out
p.001043: this subsection,
p.001043: $10,000,000 for the period of fiscal years 2011 through 2013.
p.001043: SEC. 754. ø294d¿ QUENTIN N. BURDICK PROGRAM FOR RURAL INTER- DISCIPLINARY TRAINING.
p.001043: (a) GRANTS.—The Secretary may make grants or contracts under this section to help entities fund authorized
p.001043: activities under an application approved under subsection (c).
p.001043: (b) USE OF AMOUNTS.—
p.001043: (1) IN GENERAL.—Amounts provided under subsection (a) shall be used by the recipients to fund
p.001043: interdisciplinary train- ing projects designed to—
p.001043: (A) use new and innovative methods to train health care practitioners to provide services in rural areas;
p.001043: (B) demonstrate and evaluate innovative interdiscipli- nary methods and models designed to provide access
p.001043: to cost-effective comprehensive health care;
p.001043: (C) deliver health care services to individuals residing in rural areas;
p.001043: (D) enhance the amount of relevant research con- ducted concerning health care issues in rural areas; and
p.001043: (E) increase the recruitment and retention of health care practitioners from rural areas and make rural
p.001043: prac- tice a more attractive career choice for health care practi- tioners.
p.001043: (2) METHODS.—A recipient of funds under subsection (a) may use various methods in carrying out the projects
p.001043: described in paragraph (1), including—
p.001043: (A) the distribution of stipends to students of eligible applicants;
p.001043: (B) the establishment of a post-doctoral fellowship pro- gram;
p.001043: (C) the training of faculty in the economic and logistical problems confronting rural health care
p.001043: delivery systems; or
p.001043: (D) the purchase or rental of transportation and tele- communication equipment where the need for such
p.001043: equip- ment due to unique characteristics of the rural area is demonstrated by the recipient.
p.001043: (3) ADMINISTRATION.—
p.001043: (A) IN GENERAL.—An applicant shall not use more than 10 percent of the funds made available to such appli- cant
p.001043: under subsection (a) for administrative expenses.
p.001043: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: PUBLIC HEALTH SERVICE ACT
p.001045: Sec. 755
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p.001051: community- based settings that integrate primary care with mental and substance use disorders prevention and
p.001051: treatment services;
p.001051: (2) training for nurse practitioners, physician assistants, health service psychologists, and social workers
p.001051: to provide mental and substance use disorders services in underserved community-based settings that
p.001051: integrate primary care and mental and substance use disorders services; and
p.001051: (3) establishing, maintaining, or improving academic units or programs that—
p.001051: (A) provide training for students or faculty, including through clinical experiences and research, to
p.001051: improve the ability to be able to recognize, diagnose, and treat mental and substance use disorders, with a
p.001051: special focus on addic- tion; or
p.001051: (B) develop evidence-based practices or recommenda- tions for the design of the units or programs
p.001051: described in subparagraph (A), including curriculum content standards.
p.001051: (b) ACTIVITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—A recipient of a grant under subsection (a)(1)—
p.001051: (A) shall use the grant funds—
p.001051: (i)(I) to plan, develop, and operate a training pro- gram for medical psychiatry residents and fellows
p.001051: in addiction medicine practicing in eligible entities de- scribed in subsection (c)(1); or
p.001051: (II) to train new psychiatric residents and fellows in addiction medicine to provide and expand access to
p.001051: integrated mental and substance use disorders serv- ices; and
p.001051: (ii) to provide at least 1 training track that is—
p.001051: (I) a virtual training track that includes an in-person rotation at a teaching health center or
p.001051: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: Sec. 760 PUBLIC HEALTH SERVICE ACT 1052
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p.001051: tinues to support the care of patients at the teach- ing health center or in the community-based set- ting
p.001051: through the use of health information tech- nology and, as appropriate, telehealth services;
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p.001053: (C) demonstrate experience in using health informa- tion technology and, as appropriate, telehealth to
p.001053: sup- port—
p.001053: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001053: Sec. 760 PUBLIC HEALTH SERVICE ACT 1054
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p.001053: January 30, 2020
p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
...

p.001061: or
p.001061: (D) develop educational methods and distance-based approaches or technology that address adult learning re-
p.001061: quirements and increase knowledge and skills related to community-based cultural diversity in public health
p.001061: edu- cation.
p.001061: (2) SEVERE SHORTAGE DISCIPLINES.—Amounts provided under grants or contracts under this section may be
p.001061: used for the operation of programs designed to award traineeships to students in accredited schools of
p.001061: public health who enter edu- cational programs in fields where there is a severe shortage of public health
p.001061: professionals, including epidemiology, biostatis- tics, environmental health, toxicology, public health
p.001061: nursing, nutrition, preventive medicine, maternal and child health, and behavioral and mental health professions.
p.001061: SEC. 766. ø295a¿ PUBLIC HEALTH TRAINING CENTERS.
p.001061: (a) IN GENERAL.—The Secretary may make grants or contracts for the operation of public health training centers.
p.001061: (b) ELIGIBLE ENTITIES.—
p.001061: (1) IN GENERAL.—A public health training center shall be an accredited school of public health, or another
p.001061: public or non- profit private institution accredited for the provision of grad- uate or specialized training in
p.001061: public health, that plans, devel- ops, operates, and evaluates projects that are in furtherance of the goals
p.001061: established by the Secretary for the year 2000 in the areas of preventive medicine, health promotion and disease
p.001061: prevention, or improving access to and quality of health serv- ices in medically underserved communities.
p.001061: (2) PREFERENCE.—In awarding grants or contracts under this section the Secretary shall give preference to
p.001061: accredited schools of public health.
p.001061: (c) CERTAIN REQUIREMENTS.—With respect to a public health training center, an award may not be made
p.001061: under subsection (a) unless the program agrees that it—
p.001061: (1) will establish or strengthen field placements for stu- dents in public or nonprofit private health
p.001061: agencies or organi- zations;
p.001061: (2) will involve faculty members and students in collabo- rative projects to enhance public health
p.001061: services to medically underserved communities;
p.001061: (3) will specifically designate a geographic area or medi- cally underserved population to be served by
p.001061: the center that shall be in a location removed from the main location of the
p.001061: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001061:
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p.001061: Sec. 767 PUBLIC HEALTH SERVICE ACT 1062
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p.001081: its principal functions identifying and implementing strategies and activities that ad- dress health care workforce
p.001081: needs in its service area, in coordi- nation with the local workforce investment boards.
p.001081: (14) CLINICAL SOCIAL WORKER.—The term ‘‘clinical social worker’’ has the meaning given the term in section
p.001081: 1861(hh)(1) of the Social Security Act (42 U.S.C. 1395x(hh)(1)).
p.001081: (15) CULTURAL COMPETENCY.—The term ‘‘cultural com- petency’’ shall be defined by the Secretary in a
p.001081: manner con- sistent with section 1707(d)(3).
p.001081: (16) DIRECT CARE WORKER.—The term ‘‘direct care worker’’ has the meaning given that term in the 2010
p.001081: Standard Occu- pational Classifications of the Department of Labor for Home Health Aides [31–1011],
p.001081: Psychiatric Aides [31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
p.001081: (17) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001081: given that term in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
p.001081: (18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.— The term ‘‘frontier health professional shortage area’’
p.001081: means an area—
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p.001081: (A) with a population density less than 6 persons per square mile within the service area; and
p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: 1083
p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
...

p.001091: years, the grant or contract recipient shall provide the Secretary with plans for immediately improving such rates.
p.001091: (3) INELIGIBILITY.—A recipient described in paragraph (2) shall be ineligible for continued funding under
p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
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p.001091: January 30, 2020
p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: Sec. 831 PUBLIC HEALTH SERVICE ACT 1092
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
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p.001111: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001111: PART I—FUNDING
p.001111: SEC. 871. ø298d¿ AUTHORIZATION OF APPROPRIATIONS.
p.001111: For the purpose of carrying out parts B, C, and D (subject to section 851(g)), there are
p.001111: authorized to be appropriated
p.001111: $338,000,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011
p.001111: through 2016.
p.001111:
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p.001111: January 30, 2020 As Amended Through P.L. 116-94,
p.001111: Enacted December 20, 2019
p.001111:
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p.001111: Sec. 901 PUBLIC HEALTH SERVICE ACT 1112
p.001111: TITLE IX—AGENCY FOR HEALTHCARE RESEARCH AND QUALITY 1
p.001111: PART A—ESTABLISHMENT AND GENERAL DUTIES
p.001111: SEC. 901. ø299¿ MISSION AND DUTIES.
p.001111: (a) IN GENERAL.—There is established within the Public Health Service an agency to be known
p.001111: as the Agency for Healthcare Research and Quality, which shall be headed by a di- rector appointed by
p.001111: the Secretary. The Secretary shall carry out this title acting through the Director.
p.001111: (b) MISSION.—The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of
p.001111: health services, and access to such services, through the establishment of a broad base of scientific research and
p.001111: through the promotion of improvements in clinical and health system practices, including the prevention of
p.001111: diseases and other health conditions. The Agency shall promote health care quality improvement by conducting
p.001111: and supporting—
p.001111: (1) research that develops and presents scientific evidence regarding all aspects of health care, including—
p.001111: (A) the development and assessment of methods for enhancing patient participation in their own care and
p.001111: for facilitating shared patient-physician decision-making;
p.001111: (B) the outcomes, effectiveness, and cost-effectiveness of health care practices, including preventive
p.001111: measures and long-term care;
p.001111: (C) existing and innovative technologies;
p.001111: (D) the costs and utilization of, and access to health care;
p.001111: (E) the ways in which health care services are orga- nized, delivered, and financed and the interaction and
p.001111: im- pact of these factors on the quality of patient care;
p.001111: (F) methods for measuring quality and strategies for improving quality; and
p.001111: (G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best prac-
p.001111: tices and health benefits, the determinants and impact of their use of this information;
p.001111: (2) the synthesis and dissemination of available scientific evidence for use by patients, consumers,
p.001111: practitioners, pro- viders, purchasers, policy makers, and educators; and
p.001111: (3) initiatives to advance private and public efforts to im- prove health care quality.
p.001111: (c) REQUIREMENTS WITH RESPECT TO RURAL AND INNER-CITY AREAS AND PRIORITY POPULATIONS.—
p.001111: (1) RESEARCH, EVALUATIONS AND DEMONSTRATION PROJECTS.—In carrying out this title, the
p.001111: Director shall con-
p.001111:
p.001111:
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p.001111: January 30, 2020
p.001111: 1 Section 2 of Public Law 106–129 (113 Stat. 1653) designated the Agency as the Agency for Healthcare
p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001113: 1113
p.001113: PUBLIC HEALTH SERVICE ACT
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p.001113:
p.001113:
p.001113:
p.001113:
p.001113: January 30, 2020
p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
p.001113: (5) health care technologies, facilities, and equipment;
p.001113: (6) health care costs, productivity, organization, and mar- ket forces;
p.001113: (7) health promotion and disease prevention, including clinical preventive services;
p.001113: (8) health statistics, surveys, database development, and epidemiology; and
p.001113: (9) medical liability.
p.001113: (b) HEALTH SERVICES TRAINING GRANTS.—
p.001113: (1) IN GENERAL.—The Director may provide training grants in the field of health services research related to
p.001113: activities au- thorized under subsection (a), to include pre- and post-doctoral fellowships and training programs,
p.001113: young investigator awards, and other programs and activities as appropriate. In carrying out this subsection,
p.001113: the Director shall make use of funds made available under section 487(d)(3) as well as other appropriated funds.
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001113: Sec. 903 PUBLIC HEALTH SERVICE ACT 1114
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p.001113: services research, demonstration projects, evaluations, training, and policy analysis with respect to the
p.001113: mat- ters referred to in subsection (a).
p.001113: (d) RELATION TO CERTAIN AUTHORITIES REGARDING SOCIAL SE- CURITY.—Activities authorized in this section shall be
p.001113: appropriately coordinated with experiments, demonstration projects, and other related activities authorized by
p.001113: the Social Security Act and the So- cial Security Amendments of 1967. Activities under subsection (a)(2) of
p.001113: this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall
p.001113: be carried out con- sistent with section 1142 of such Act.
p.001113: (e) DISCLAIMER.—The Agency shall not mandate national standards of clinical practice or quality health care
p.001113: standards. Rec- ommendations resulting from projects funded and published by the Agency shall include a corresponding
p.001113: disclaimer.
p.001113: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to imply that the Agency’s role is to
p.001113: mandate a national standard or specific approach to quality measurement and report- ing. In research and
p.001113: quality improvement activities, the Agency shall consider a wide range of choices, providers, health care deliv-
p.001113: ery systems, and individual preferences.
p.001113: SEC. 903. ø299a–1¿ RESEARCH ON HEALTH DISPARITIES.
p.001113: (a) IN GENERAL.—The Director shall—
p.001113: (1) conduct and support research to identify populations for which there is a significant disparity in
p.001113: the quality, out- comes, cost, or use of health care services or access to and sat- isfaction with such services,
p.001113: as compared to the general popu- lation;
p.001113: (2) conduct and support research on the causes of and bar- riers to reducing the health disparities identified in
p.001113: paragraph (1), taking into account such factors as socioeconomic status, attitudes toward health, the language
p.001113: spoken, the extent of for- mal education, the area or community in which the population resides, and other factors the
p.001113: Director determines to be appro- priate;
p.001113: (3) conduct and support research and support demonstra- tion projects to identify, test, and evaluate strategies
p.001113: for reduc- ing or eliminating health disparities, including development or identification of effective service delivery
p.001113: models, and dissemi- nate effective strategies and models;
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001115: 1115
p.001115: PUBLIC HEALTH SERVICE ACT
p.001115: Sec. 903
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p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
p.001115: (5) in carrying out section 902(c), provide support to in- crease the number of researchers who are
p.001115: members of health disparity populations, and the health services research capac- ity of institutions that
p.001115: train such researchers; and
p.001115: (6) beginning with fiscal year 2003, annually submit to the Congress a report regarding prevailing disparities in
p.001115: health care delivery as it relates to racial factors and socioeconomic factors in priority populations.
p.001115: (b) RESEARCH AND DEMONSTRATION PROJECTS.—
p.001115: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor shall conduct and support research and support
p.001115: demonstra- tions to—
p.001115: (A) identify the clinical, cultural, socioeconomic, geo- graphic, and organizational factors that
p.001115: contribute to health disparities, including minority health disparity pop- ulations, which research shall include
p.001115: behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach,
p.001115: and the availability of related support services (such as cultural and linguistic services);
p.001115: (B) identify and evaluate clinical and organizational strategies to improve the quality, outcomes, and
p.001115: access to care for health disparity populations, including minority health disparity populations;
p.001115: (C) test such strategies and widely disseminate those strategies for which there is scientific evidence of
p.001115: effective- ness; and
p.001115: (D) determine the most effective approaches for dis- seminating research findings to health disparity
p.001115: popu- lations, including minority populations.
p.001115: (2) USE OF CERTAIN STRATEGIES.—In carrying out this sec- tion, the Director shall implement research
p.001115: strategies and mechanisms that will enhance the involvement of individuals who are members of minority
p.001115: health disparity populations or other health disparity populations, health services researchers who are such
p.001115: individuals, institutions that train such individ- uals as researchers, members of minority health disparity pop-
p.001115: ulations or other health disparity populations for whom the Agency is attempting to improve the quality
p.001115: and outcomes of care, and representatives of appropriate tribal or other commu- nity-based organizations with respect
p.001115: to health disparity popu- lations. Such research strategies and mechanisms may include the use of—
p.001115: (A) centers of excellence that can demonstrate, either individually or through consortia, a combination of
p.001115: multi- disciplinary expertise in outcomes or quality improvement research, linkages to relevant sites of
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p.001115: (B) provider-based research networks, including health plans, facilities, or delivery system sites of care (especially
p.001115: primary care), that make extensive use of health care pro- viders who are members of health disparity populations or
p.001115: who serve patients in such populations and have the ca- pacity to evaluate and promote quality improvement;
p.001115: (C) service delivery models (such as health centers under section 330 and the Indian Health Service) to reduce
p.001115: health disparities; and
p.001115: (D) innovative mechanisms or strategies that will fa- cilitate the translation of past research
p.001115: investments into clinical practices that can reasonably be expected to ben- efit these populations.
p.001115: (c) QUALITY MEASUREMENT DEVELOPMENT.—
p.001115: (1) IN GENERAL.—To ensure that health disparity popu- lations, including minority health disparity populations,
p.001115: benefit from the progress made in the ability of individuals to measure the quality of health care delivery, the
p.001115: Director shall support the development of quality of health care measures that assess the experience of such
p.001115: populations with health care systems, such as measures that assess the access of such populations to health care,
p.001115: the cultural competence of the care provided, the quality of the care provided, the outcomes of care, or other
p.001115: as- pects of health care practice that the Director determines to be important.
p.001115: (2) EXAMINATION OF CERTAIN PRACTICES.—The Director
p.001115: shall examine the practices of providers that have a record of reducing health disparities or have experience
p.001115: in providing cul- turally competent health services to minority health disparity populations or other health
p.001115: disparity populations. In exam- ining such practices of providers funded under the authorities of this Act,
p.001115: the Director shall consult with the heads of the rel- evant agencies of the Public Health Service.
p.001115: (3) REPORT.—Not later than 36 months after the date of the enactment of this section, the Secretary, acting
p.001115: through the Director, shall prepare and submit to the appropriate commit- tees of Congress a report describing the
p.001115: state-of-the-art of qual- ity measurement for minority and other health disparity popu- lations that will identify
p.001115: critical unmet needs, the current ac- tivities of the Department to address those needs, and a de-
p.001115: scription of related activities in the private sector.
p.001115: (d) DEFINITION.—For purposes of this section:
p.001115: (1) The term ‘‘health disparity population’’ has the mean- ing given such term in section 464z–3, except that
p.001115: in addition to the meaning so given, the Director may determine that such term includes populations for which
p.001115: there is a significant dis- parity in the quality, outcomes, cost, or use of health care serv- ices or access to or
p.001115: satisfaction with such services as compared to the general population.
p.001115: (2) The term ‘‘minority’’, with respect to populations, refers to racial and ethnic minority groups as defined in
p.001115: section 1707.
p.001115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001117: PUBLIC HEALTH SERVICE ACT
p.001117: Sec. 912
p.001117:
p.001117: PART B—HEALTH CARE IMPROVEMENT RESEARCH
p.001117: SEC. 911. ø299b¿ HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
p.001117: (a) EVIDENCE RATING SYSTEMS.—In collaboration with experts from the public and private sector, the Agency
p.001117: shall identify and disseminate methods or systems to assess health care research re- sults, particularly methods
p.001117: or systems to rate the strength of the scientific evidence underlying health care practice, recommenda-
p.001117: tions in the research literature, and technology assessments. The Agency shall make methods or systems
p.001117: for evidence rating widely available. Agency publications containing health care recommenda- tions shall indicate
p.001117: the level of substantiating evidence using such methods or systems.
p.001117: (b) HEALTH CARE IMPROVEMENT RESEARCH CENTERS AND PRO-
p.001117: VIDER-BASED RESEARCH NETWORKS.—
p.001117: (1) IN GENERAL.—In order to address the full continuum of care and outcomes research, to link research to
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p.001119: January 30, 2020
p.001119: (B) The conduct of research on the comparative effec- tiveness, cost-effectiveness, and safety of drugs,
p.001119: biological products, and devices.
p.001119: (C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be
p.001119: ex- pended to assist the Secretary in the review of new drugs, biological products, and devices.
p.001119: (c) REDUCING ERRORS IN MEDICINE.—The Director shall, in ac- cordance with part C, conduct and support research and
p.001119: build pri- vate-public partnerships to—
p.001119: (1) identify the causes of preventable health care errors and patient injury in health care delivery;
p.001119: (2) develop, demonstrate, and evaluate strategies for re- ducing errors and improving patient safety; and
p.001119: (3) disseminate such effective strategies throughout the health care industry.
p.001119: SEC. 913. ø299b–2¿ INFORMATION ON QUALITY AND COST OF CARE.
p.001119: (a) IN GENERAL.—The Director shall—
p.001119: (1) conduct a survey to collect data on a nationally rep- resentative sample of the population on the
p.001119: cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the
p.001119: types of health care services Americans use, their access to health care services, frequency of use, how much
p.001119: is paid for the services used, the source of those pay- ments, the types and costs of private health
p.001119: insurance, access, satisfaction, and quality of care for the general population in- cluding rural residents
p.001119: and also for populations identified in section 901(c); and
p.001119: (2) develop databases and tools that provide information to States on the quality, access, and use of health
p.001119: care services provided to their residents.
p.001119: (b) QUALITY AND OUTCOMES INFORMATION.—
p.001119: (1) IN GENERAL.—Beginning in fiscal year 2001, the Direc- tor shall ensure that the survey conducted under
p.001119: subsection (a)(1) will—
p.001119: (A) identify determinants of health outcomes and func- tional status, including the health care needs of popu-
p.001119: lations identified in section 901(c), provide data to study the relationships between health care quality,
p.001119: outcomes, access, use, and cost, measure changes over time, and monitor the overall national impact of
p.001119: Federal and State policy changes on health care;
p.001119: (B) provide information on the quality of care and pa- tient outcomes for frequently occurring clinical
p.001119: conditions for a nationally representative sample of the population in- cluding rural residents; and
p.001119: (C) provide reliable national estimates for children and persons with special health care needs through the use
p.001119: of supplements or periodic expansions of the survey.
p.001119: In expanding the Medical Expenditure Panel Survey, as in ex- istence on the date of the enactment of this title in
p.001119: fiscal year 2001 to collect information on the quality of care, the Director
p.001119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001119: Sec. 914 PUBLIC HEALTH SERVICE ACT 1120
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p.001119: health informa- tion, the Agency shall conduct and support research, evaluations, and initiatives to advance—
p.001119: (1) the use of information systems for the study of health care quality and outcomes, including the
p.001119: generation of both in- dividual provider and plan-level comparative performance data;
p.001119: (2) training for health care practitioners and researchers in the use of information systems;
p.001119: (3) the creation of effective linkages between various sources of health information, including the
p.001119: development of in- formation networks;
p.001119: (4) the delivery and coordination of evidence-based health care services, including the use of real-time
p.001119: health care deci- sion-support programs;
p.001119: (5) the utility and comparability of health information data and medical vocabularies by addressing issues
p.001119: related to the content, structure, definitions and coding of such information and data in consultation
p.001119: with appropriate Federal, State and private entities;
p.001119: (6) the use of computer-based health records in all settings for the development of personal health records for
p.001119: individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations;
p.001119: and
p.001119: (7) the protection of individually identifiable information in health services research and health care quality
p.001119: improvement.
p.001119: (b) DEMONSTRATION.—The Agency shall support demonstra- tions into the use of new information tools aimed
p.001119: at improving shared decision-making between patients and their care-givers.
p.001119: (c) FACILITATING PUBLIC ACCESS TO INFORMATION.—The Direc- tor shall work with appropriate public and private
p.001119: sector entities to facilitate public access to information regarding the quality of and consumer
p.001119: satisfaction with health care.
p.001119: SEC. 915. ø299b–4¿ RESEARCH SUPPORTING PRIMARY CARE AND AC- CESS IN UNDERSERVED AREAS.
p.001119: (a) PREVENTIVE SERVICES TASK FORCE.—
p.001119: (1) ESTABLISHMENT AND PURPOSE.—The Director shall con- vene an independent Preventive Services Task Force
p.001119: (referred to in this subsection as the ‘‘Task Force’’) to be composed of in- dividuals with appropriate expertise. Such
p.001119: Task Force shall re- view the scientific evidence related to the effectiveness, appro- priateness, and
p.001119: cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health
p.001119: care community, and updating previous clinical preventive rec-
p.001119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001121: 1121
p.001121: PUBLIC HEALTH SERVICE ACT
p.001121: Sec. 915
p.001121:
p.001121: ommendations, to be published in the Guide to Clinical Preven- tive Services (referred to in this section as the
p.001121: ‘‘Guide’’), for in- dividuals and organizations delivering clinical services, includ- ing primary care
p.001121: professionals, health care systems, profes- sional societies, employers, community organizations, non-prof- it
p.001121: organizations, Congress and other policy-makers, govern- mental public health agencies, health care quality
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p.001131: make the draft report available for public comment and submit the draft report to the Institute of Medicine for review.
p.001131: (2) FINAL REPORT.—Not later than 1 year after the date de- scribed in paragraph (1), the Secretary shall submit a final
p.001131: re- port to the Congress.
p.001131: SEC. 923. ø299b–23¿ NETWORK OF PATIENT SAFETY DATABASES.
p.001131: (a) IN GENERAL.—The Secretary shall facilitate the creation of, and maintain, a network of patient safety
p.001131: databases that provides an interactive evidence-based management resource for providers, patient safety
p.001131: organizations, and other entities. The network of databases shall have the capacity to accept, aggregate
p.001131: across the network, and analyze nonidentifiable patient safety work product voluntarily reported by patient
p.001131: safety organizations, providers, or other entities. The Secretary shall assess the feasibility of pro-
p.001131: viding for a single point of access to the network for qualified re- searchers for information
p.001131: aggregated across the network and, if feasible, provide for implementation.
p.001131: (b) DATA STANDARDS.—The Secretary may determine common formats for the reporting to and among the network of
p.001131: patient safe- ty databases maintained under subsection (a) of nonidentifiable pa- tient safety work product,
p.001131: including necessary work product ele- ments, common and consistent definitions, and a standardized com- puter
p.001131: interface for the processing of such work product. To the ex- tent practicable, such standards shall be
p.001131: consistent with the ad- ministrative simplification provisions of part C of title XI of the So- cial Security Act.
p.001131: (c) USE OF INFORMATION.—Information reported to and among the network of patient safety databases under
p.001131: subsection (a) shall be used to analyze national and regional statistics, including trends and patterns of health
p.001131: care errors. The information resulting from such analyses shall be made available to the public and included
p.001131: in the annual quality reports prepared under section 913(b)(2).
p.001131: SEC. 924. ø299b–24¿ PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.
p.001131: (a) CERTIFICATION.—
p.001131: (1) INITIAL CERTIFICATION.—An entity that seeks to be a patient safety organization shall submit an initial
p.001131: certification to the Secretary that the entity—
p.001131: (A) has policies and procedures in place to perform each of the patient safety activities described in
p.001131: section 921(5); and
p.001131: (B) upon being listed under subsection (d), will comply with the criteria described in subsection (b).
p.001131: (2) SUBSEQUENT CERTIFICATIONS.—An entity that is a pa- tient safety organization shall submit every 3
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p.001135: (2) return such work product or data to the entity that submitted the work product or data; or
p.001135: (3) if returning such work product or data to such entity is not practicable, destroy such work product or
p.001135: data.
p.001135: SEC. 925. ø299b–24a¿ ACTIVITIES REGARDING WOMEN’S HEALTH.
p.001135: (a) ESTABLISHMENT.—There is established within the Office of the Director, an Office of Women’s Health
p.001135: and Gender-Based Re- search (referred to in this section as the ‘‘Office’’). The Office shall be headed by a
p.001135: director who shall be appointed by the Director of Healthcare and Research Quality.
p.001135: (b) PURPOSE.—The official designated under subsection (a) shall—
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p.001135: (1) report to the Director on the current Agency level of ac- tivity regarding women’s health, across, where
p.001135: appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the
p.001135: development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes,
p.001135: delivery of health care services, quality of care, and access to health care;
p.001135: (2) establish short-range and long-range goals and objec- tives within the Agency for research important
p.001135: to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within
p.001135: the Agency that relate to health services and medical effectiveness research, for issues of particular concern to
p.001135: women;
p.001135: (3) identify projects in women’s health that should be con- ducted or supported by the Agency;
p.001135: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.001135: profes- sionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
p.001135: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.001135: Health (established under section 229(b)(4)).
p.001135: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001135: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.001135: SEC. 926. ø299b–25¿ TECHNICAL ASSISTANCE.
p.001135: The Secretary, acting through the Director, may provide tech- nical assistance to patient safety
p.001135: organizations, including con-
p.001135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001145: or in collaboration with primary care extension programs es- tablished in section 399V–1;
p.001145: (4) submit a plan for meeting the requirements under sub- section (c); and
p.001145: (5) submit to the Secretary such other information as the Secretary may require.
p.001145: (c) MTM SERVICES TO TARGETED INDIVIDUALS.—The MTM services provided with the assistance of a grant or
p.001145: contract award- ed under subsection (a) shall, as allowed by State law including ap- plicable collaborative pharmacy
p.001145: practice agreements, include—
p.001145: (1) performing or obtaining necessary assessments of the health and functional status of each patient
p.001145: receiving such MTM services;
p.001145: (2) formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber
p.001145: and the pa- tient or caregiver or authorized representative of the patient;
p.001145: (3) selecting, initiating, modifying, recommending changes to, or administering medication therapy;
p.001145: (4) monitoring, which may include access to, ordering, or performing laboratory assessments, and
p.001145: evaluating the re- sponse of the patient to therapy, including safety and effective- ness;
p.001145: (5) performing an initial comprehensive medication review to identify, resolve, and prevent medication-related
p.001145: problems, including adverse drug events, quarterly targeted medication reviews for ongoing monitoring, and
p.001145: additional followup inter- ventions on a schedule developed collaboratively with the pre- scriber;
p.001145: (6) documenting the care delivered and communicating es- sential information about such care, including a
p.001145: summary of the medication review, and the recommendations of the phar- macist to other appropriate health care
p.001145: providers of the patient in a timely fashion;
p.001145: (7) providing education and training designed to enhance the understanding and appropriate use of the
p.001145: medications by the patient, caregiver, and other authorized representative;
p.001145: (8) providing information, support services, and resources and strategies designed to enhance patient
p.001145: adherence with therapeutic regimens;
p.001145: (9) coordinating and integrating MTM services within the broader health care management services provided
p.001145: to the pa- tient; and
p.001145: (10) such other patient care services allowed under phar- macist scopes of practice in use in other Federal
p.001145: programs that have implemented MTM services.
p.001145: (d) TARGETED INDIVIDUALS.—MTM services provided by li- censed pharmacists under a grant or contract
p.001145: awarded under sub- section (a) shall be offered to targeted individuals who—
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p.001151: (g) AUTHORITY TO CONTRACT WITH THE INSTITUTE.—Agencies and instrumentalities of the Federal Government may
p.001151: enter into agreements with the Institute, and accept and retain funds, for the conduct and support of research
p.001151: described in this part, provided that the research to be conducted or supported under such agree- ments
p.001151: is authorized under the governing statutes of such agencies and instrumentalities.
p.001151: PART E—GENERAL PROVISIONS
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p.001151: January 30, 2020
p.001151: SEC. 941. ø299c¿ ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.
p.001151: (a) ESTABLISHMENT.—There is established an advisory council to be known as the National Advisory
p.001151: Council for Healthcare Re- search and Quality.
p.001151: (b) DUTIES.—
p.001151: (1) IN GENERAL.—The Advisory Council shall advise the Secretary and the Director with respect to
p.001151: activities proposed or undertaken to carry out the mission of the Agency under section 901(b).
p.001151: (2) CERTAIN RECOMMENDATIONS.—Activities of the Advi- sory Council under paragraph (1) shall include
p.001151: making rec- ommendations to the Director regarding—
p.001151: (A) priorities regarding health care research, espe- cially studies related to quality, outcomes, cost and the
p.001151: uti- lization of, and access to, health care services;
p.001151: (B) the field of health care research and related dis- ciplines, especially issues related to training
p.001151: needs, and dissemination of information pertaining to health care quality; and
p.001151: (C) the appropriate role of the Agency in each of these areas in light of private sector activity and
p.001151: identification of opportunities for public-private sector partnerships.
p.001151: (c) MEMBERSHIP.—
p.001151: (1) IN GENERAL.—The Advisory Council shall, in accord- ance with this subsection, be composed of
p.001151: appointed members and ex officio members. All members of the Advisory Council shall be voting members other
p.001151: than the individuals designated under paragraph (3)(B) as ex officio members.
p.001151: (2) APPOINTED MEMBERS.—The Secretary shall appoint to the Advisory Council 21 appropriately qualified
p.001151: individuals. At least 17 members of the Advisory Council shall be representa- tives of the public who are not
p.001151: officers or employees of the United States and at least 1 member who shall be a specialist in the rural aspects of
p.001151: 1 or more of the professions or fields de- scribed in subparagraphs (A) through (G). The Secretary shall
p.001151: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001163: testing, diagnosis, coun- seling, and treatment of individuals respecting genetic diseases. Services under
p.001163: such program shall be made available through fa- cilities of the Service to persons requesting such
p.001163: services, and the program shall provide appropriate publicity of the availability and voluntary nature of such
p.001163: services.
p.001163: SEC. 1106. ø300b–5¿ SICKLE CELL DISEASE AND OTHER HERITABLE BLOOD DISORDERS RESEARCH, SURVEILLANCE, PREVEN-
p.001163: TION, AND TREATMENT.
p.001163: (a) GRANTS.—
p.001163: (1) IN GENERAL.—The Secretary may award grants related to heritable blood disorders, including sickle cell
p.001163: disease, for one or more of the following purposes:
p.001163: (A) To collect and maintain data on such diseases and conditions, including subtypes as applicable, and their
p.001163: as- sociated health outcomes and complications, including for the purpose of—
p.001163: (i) improving national incidence and prevalence data;
p.001163: (ii) identifying health disparities, including the ge- ographic distribution, related to such diseases and
p.001163: conditions;
p.001163: (iii) assessing the utilization of therapies and strategies to prevent complications; and
p.001163: (iv) evaluating the effects of genetic, environ- mental, behavioral, and other risk factors that may af-
p.001163: fect such individuals.
p.001163: (B) To conduct public health activities with respect to such conditions, which may include—
p.001163: (i) developing strategies to improve health out- comes and access to quality health care for the screen- ing
p.001163: for, and treatment and management of, such dis- eases and conditions, including through public-private
p.001163: partnerships;
p.001163: (ii) providing support to community-based organi- zations and State and local health departments in con- ducting
p.001163: education and training activities for patients, communities, and health care providers concerning such
p.001163: diseases and conditions;
p.001163: (iii) supporting State health departments and re- gional laboratories, including through training, in test- ing
p.001163: to identify such diseases and conditions, including specific forms of sickle cell disease, in individuals of all ages;
p.001163: and
p.001163: (iv) the identification and evaluation of best prac- tices for treatment of such diseases and conditions, and
p.001163: prevention and management of their related com- plications.
p.001163: (2) POPULATION INCLUDED.—The Secretary shall, to the ex- tent practicable, award grants under this subsection to
p.001163: eligible entities across the United States to improve data on the inci-
p.001163: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001165: PUBLIC HEALTH SERVICE ACT
p.001165: Sec. 1106
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p.001171: (4) provide technical assistance, as appropriate, to individ- uals and organizations regarding the submission of
p.001171: nomina- tions to the uniform screening panel, including prior to the submission of such nominations;
p.001171: (5) take appropriate steps, at its discretion, to prepare for the review of nominations prior to their
p.001171: submission, including for conditions for which a screening method has been validated but other nomination criteria are
p.001171: not yet met, in order to facili- tate timely action by the Advisory Committee once such sub- mission has been
p.001171: received by the Committee;
p.001171: (6) develop a model decision-matrix for newborn screening expansion, including an evaluation of the
p.001171: potential public health impact, including the cost of such expansion, and peri- odically update the
p.001171: recommended uniform screening panel, as appropriate, based on such decision-matrix;
p.001171: (7) consider ways to ensure that all States attain the ca- pacity to screen for the conditions
p.001171: described in paragraph (3), and include in such consideration the results of grant funding under section
p.001171: 1109; and
p.001171: (8) provide such recommendations, advice or information as may be necessary to enhance, expand or improve the
p.001171: ability of the Secretary to reduce the mortality or morbidity from heri- table disorders, which may include
p.001171: recommendations, advice, or information dealing with—
p.001171: (A) follow-up activities, including those necessary to achieve best practices in rapid diagnosis and
p.001171: appropriate treatment in the short-term, and those that ascertain long- term case management outcomes and appropriate
p.001171: access to related services;
p.001171: (B) implementation, monitoring, and evaluation of newborn screening activities, including diagnosis,
p.001171: screen- ing, follow-up, and treatment activities;
p.001171: (C) diagnostic and other technology used in screening;
p.001171: (D) the availability and reporting of testing for condi- tions for which there is no existing treatment,
p.001171: including information on cost and incidence;
p.001171: (E) conditions not included in the recommended uni- form screening panel that are treatable with Food
p.001171: and Drug Administration-approved products or other safe and effective treatments, as determined by
p.001171: scientific evidence and peer review;
p.001171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001171: Sec. 1111 PUBLIC HEALTH SERVICE ACT 1172
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p.001179: (3) by making training for original certification, and con- tinuing education, in the provision and
p.001179: management of emer- gency medical services more accessible to emergency medical personnel in rural areas
p.001179: through telecommunications, home studies, providing teachers and training at locations accessible to such personnel,
p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
p.001179: (6) by increasing communication and coordination with State trauma systems.
p.001179: (b) SPECIAL CONSIDERATION FOR CERTAIN RURAL AREAS.—In making grants under subsection (a), the
p.001179: Secretary shall give spe- cial consideration to any applicant for the grant that will provide services
p.001179: under the grant in any rural area identified by a State under section 1214(d)(1).
p.001179: (c) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.001179: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001179: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001181: (d) PRIORITY.—In making grants under this section, the Sec- retary shall give priority to applicants that
p.001181: will use the grants to focus on improving access to trauma care systems.
p.001181: (e) SPECIAL CONSIDERATION.—In awarding grants under this section, the Secretary shall give special
p.001181: consideration to projects that demonstrate strong State or local support, including avail- ability of
p.001181: non-Federal contributions.
p.001181: SEC. 1204. ø300d–6¿ COMPETITIVE GRANTS FOR REGIONALIZED SYS- TEMS FOR EMERGENCY CARE RESPONSE.
p.001181: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall
p.001181: award not fewer than 4 multiyear contracts or competitive grants to eligible entities to support pilot projects that
p.001181: design, implement, and evaluate inno- vative models of regionalized, comprehensive, and accountable
p.001181: emergency care and trauma systems.
p.001181: (b) ELIGIBLE ENTITY; REGION.—In this section:
p.001181: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means—
p.001181: (A) a State or a partnership of 1 or more States and 1 or more local governments; or
p.001181: (B) an Indian tribe (as defined in section 4 of the In- dian Health Care Improvement Act) or a
p.001181: partnership of 1 or more Indian tribes.
p.001181: (2) REGION.—The term ‘‘region’’ means an area within a State, an area that lies within multiple States,
p.001181: or a similar area (such as a multicounty area), as determined by the Sec- retary.
p.001181: (3) EMERGENCY SERVICES.—The term ‘‘emergency services’’ includes acute, prehospital, and trauma care.
p.001181: (c) PILOT PROJECTS.—The Secretary shall award a contract or grant under subsection (a) to an eligible entity
p.001181: that proposes a pilot project to design, implement, and evaluate an emergency medical and trauma system that—
p.001181: (1) coordinates with public health and safety services, emergency medical services, medical facilities,
p.001181: trauma centers, and other entities in a region to develop an approach to emer- gency medical and trauma system
p.001181: access throughout the re- gion, including 9–1–1 Public Safety Answering Points and emergency medical
p.001181: dispatch;
p.001181: (2) includes a mechanism, such as a regional medical di- rection or transport communications system,
p.001181: that operates throughout the region to ensure that the patient is taken to the medically appropriate
p.001181: facility (whether an initial facility or a higher-level facility) in a timely fashion;
p.001181: (3) allows for the tracking of prehospital and hospital re- sources, including inpatient bed capacity,
p.001181: emergency depart- ment capacity, trauma center capacity, on-call specialist cov- erage, ambulance diversion
p.001181: status, and the coordination of such tracking with regional communications and hospital des- tination
p.001181: decisions; and
p.001181: (4) includes a consistent region-wide prehospital, hospital, and interfacility data management system that—
p.001181: (A) submits data to the National EMS Information System, the National Trauma Data Bank, and others;
p.001181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001183: (B) the costs of improving the quality and availability of emergency medical services in rural areas of the
p.001183: State.
p.001183: (3) INITIAL YEAR OF PAYMENTS.—The Secretary may not re- quire a State to make non-Federal contributions as a condition
p.001183: of receiving payments under section 1211(a) for the first fiscal year of such payments to the State.
p.001183: (b) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBU- TION.—With respect to compliance with subsection
p.001183: (a) as a condi- tion of receiving payments under section 1211(a)—
p.001183: (1) a State may make the non-Federal contributions re- quired in such subsection in cash or in kind,
p.001183: fairly evaluated, including plant, equipment, or services; and
p.001183: (2) the Secretary may not, in making a determination of the amount of non-Federal contributions, include
p.001183: amounts pro- vided by the Federal Government or services assisted or sub- sidized to any significant extent by
p.001183: the Federal Government.
p.001183: SEC. 1213. ø300d–13¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF ALLOTMENTS.
p.001183: (a) TRAUMA CARE MODIFICATIONS TO STATE PLAN FOR EMER- GENCY MEDICAL SERVICES.—With respect to the trauma
p.001183: care com- ponent of a State plan for the provision of emergency medical serv- ices, the modifications referred to in
p.001183: section 1211(b) are such modi- fications to the State plan as may be necessary for the State in- volved to
p.001183: ensure that the plan provides for access to the highest possible quality of trauma care, and that the plan—
p.001183: (1) specifies that the modifications required pursuant to paragraphs (2) through (11) will be implemented
p.001183: by the prin- cipal State agency with respect to emergency medical services or by the designee of such agency;
p.001183: (2) specifies a public or private entity that will designate trauma care regions and trauma centers in the
p.001183: State;
p.001183: (3) subject to subsection (b), contains national standards and requirements of the American College of
p.001183: Surgeons or an- other appropriate entity for the designation of level I and level II trauma centers, and in the case
p.001183: of rural areas level III trau- ma centers (including trauma centers with specified capabili-
p.001183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001185: (9) provides for appropriate transportation and transfer policies to ensure the delivery of patients to
p.001185: designated trauma centers and other facilities within and outside of the jurisdic- tion of such system,
p.001185: including policies to ensure that only indi- viduals appropriately identified as trauma patients are trans-
p.001185: ferred to designated trauma centers, and to provide periodic re- views of the transfers and the auditing of
p.001185: such transfers that are determined to be appropriate;
p.001185: (10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
p.001185: (11) coordinates planning for trauma systems with State disaster emergency planning and bioterrorism
p.001185: hospital pre- paredness planning; and
p.001185: (12) with respect to the requirements established in this subsection, provides for coordination and
p.001185: cooperation between the State and any other State with which the State shares any standard metropolitan statistical
p.001185: area.
p.001185: (b) CERTAIN STANDARDS WITH RESPECT TO TRAUMA CARE CEN-
p.001185: TERS AND SYSTEMS.—
p.001185: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) for a fiscal year unless the
p.001185: State in- volved agrees that, in carrying out paragraphs (3) through (5) of subsection (a), the State
p.001185: will adopt standards for the des- ignation of trauma centers, and for triage, transfer, and trans- portation
p.001185: policies, and that the State will, in adopting such standards—
p.001185: (A) take into account national standards that outline resources for optimal care of injured patients;
p.001185: (B) consult with medical, surgical, and nursing spe- ciality groups, hospital associations, emergency
p.001185: medical services State and local directors, concerned advocates, and other interested parties;
p.001185: (C) conduct hearings on the proposed standards after providing adequate notice to the public concerning
p.001185: such hearing; and
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p.001187: (a) IN GENERAL.—For each fiscal year, the Secretary may not make payments to a State under section 1211(a)
p.001187: unless, subject to subsection (b), the State submits to the Secretary the trauma care component of the State plan for
p.001187: the provision of emergency medical services, including any changes to the trauma care component and any plans to
p.001187: address deficiencies in the trauma care component.
p.001187: (b) INTERIM PLAN OR DESCRIPTION OF EFFORTS.—For each fis- cal year, if a State has not completed the
p.001187: trauma care component of the State plan described in subsection (a), the State may provide, in lieu of such completed
p.001187: component, an interim component or a de- scription of efforts made toward the completion of the component.
p.001187: (c) INFORMATION RECEIVED BY STATE REPORTING AND ANALYSIS SYSTEM.—The Secretary may not make payments to a State
p.001187: under section 1211(a) unless the State agrees that the State will, not less than once each year, provide to the
p.001187: Secretary the information re- ceived by the State pursuant to section 1213(a)(7).
p.001187: (d) AVAILABILITY OF EMERGENCY MEDICAL SERVICES IN RURAL AREAS.—The Secretary may not make payments to a
p.001187: State under section 1211(a) unless—
p.001187: (1) the State identifies any rural area in the State for which—
p.001187:
p.001187:
p.001187:
p.001187: January 30, 2020
p.001187: (A) there is no system of access to emergency medical services through the telephone number 911;
p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001187: Sec. 1215 PUBLIC HEALTH SERVICE ACT 1188
p.001187:
p.001187: (B) there is no basic life-support system; or
p.001187: (C) there is no advanced life-support system; and
p.001187: (2) the State submits to the Secretary a list of rural areas identified pursuant to paragraph (1) or, if there
p.001187: are no such areas, a statement that there are no such areas.
p.001187: SEC. 1215. ø300d–15¿ RESTRICTIONS ON USE OF PAYMENTS.
p.001187: (a) IN GENERAL.—The Secretary may not, except as provided in subsection (b), make payments under section 1211(a)
p.001187: for a fiscal year unless the State involved agrees that the payments will not be expended—
p.001187: (1) for any purpose other than developing, implementing, and monitoring the modifications required by section
p.001187: 1211(b) to be made to the State plan for the provision of emergency med- ical services;
p.001187: (2) to make cash payments to intended recipients of serv- ices provided pursuant to this section;
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p.001191: the activities of the States carried out pursuant to section 1211. Such report shall in- clude an
p.001191: assessment of the extent to which Federal and State ef- forts to develop systems of trauma care and to
p.001191: designate trauma centers have reduced the incidence of mortality, and the incidence of permanent
p.001191: disability, resulting from trauma. Such report may include any recommendations of the Secretary for
p.001191: appropriate ad- ministrative and legislative initiatives with respect to trauma care.
p.001191: PART C—GENERAL PROVISIONS REGARDING PARTS A AND B
p.001191: SEC. 1231. ø300d–31¿ DEFINITIONS.
p.001191: For purposes of this part and parts A and B:
p.001191: (1) DESIGNATED TRAUMA CENTER.—The term ‘‘designated trauma center’’ means a trauma center designated in
p.001191: accord- ance with the modifications to the State plan described in sec- tion 1213.
p.001191: (2) STATE PLAN REGARDING EMERGENCY MEDICAL SERV- ICES.—The term ‘‘State plan’’, with respect to the
p.001191: provision of emergency medical services, means a plan for a comprehensive, organized system to provide for the
p.001191: access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and
p.001191: rehabilitation of patients of all ages with respect to emergency medical services.
p.001191: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.001191: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001191: (4) TRAUMA.—The term ‘‘trauma’’ means an injury result- ing from exposure to—
p.001191: (A) a mechanical force; or
p.001191: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001191: radioactive.
p.001191: (5) TRAUMA CARE COMPONENT OF STATE PLAN.—The term ‘‘trauma care component’’, with respect to components
p.001191: of the State plan for the provision of emergency medical services, means a plan for a comprehensive
p.001191: health care system, within rural and urban areas of the State, for the prompt recognition, prehospital care,
p.001191: emergency medical care, acute surgical and medical care, rehabilitation, and outcome evaluation of seri-
p.001191: ously injured patients.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001191:
p.001191:
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p.001193: demand is exceeding supply;
p.001193: (ii) for which—
p.001193: (I) annual uncompensated care costs exceed
p.001193: $10,000,000; or
p.001193: (II) at least 20 percent of emergency depart- ment visits are charity or self-pay or Medicaid pa- tients; and
p.001193: (iii) that are not eligible for substantial uncompen- sated care awards under section 1241(a)(1).
p.001193: (c) EMERGENCY AWARDS.—In awarding grants under section 1241(a)(3), the Secretary shall—
p.001193: (1) give preference to any application submitted by a trau- ma center that provides trauma care in a geographic
p.001193: area in which the availability of trauma care has significantly de- creased or will significantly
p.001193: decrease if the center is forced to close or downgrade service or growth in demand for trauma services
p.001193: exceeds capacity; and
p.001193: (2) reallocate any emergency awards funds not obligated due to insufficient, or a lack of qualified,
p.001193: applications to the significant uncompensated care award program.
p.001193: SEC. 1243. ø300d–43¿ CERTAIN AGREEMENTS.
p.001193: (a) MAINTENANCE OF FINANCIAL SUPPORT.—The Secretary may require a trauma center receiving a grant under section
p.001193: 1241(a) to maintain access to trauma services at comparable levels to the prior year during the grant period.
p.001193: (b) TRAUMA CARE REGISTRY.—The Secretary may require the trauma center receiving a grant under section
p.001193: 1241(a) to provide data to a national and centralized registry of trauma cases, in ac- cordance with
p.001193: guidelines developed by the American College of Sur- geons, and as the Secretary may otherwise require.
p.001193:
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p.001193:
p.001193: January 30, 2020
p.001193: 1 So in law. Subsection (b) includes a paragraph (1) but does not include subsequent
p.001193: paragaraphs.
p.001193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001195: 1195
p.001195: PUBLIC HEALTH SERVICE ACT
p.001195: Sec. 1245
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p.001195: January 30, 2020
p.001195: SEC. 1251. ø300d–51¿ RESIDENCY TRAINING PROGRAMS IN EMER- GENCY MEDICINE.
p.001195: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001195: of planning and de- veloping approved residency training programs in emergency medi- cine.
p.001195: (b) IDENTIFICATION AND REFERRAL OF DOMESTIC VIOLENCE.— The Secretary may make a grant under subsection
p.001195: (a) only if the applicant involved agrees that the training programs under sub- section (a) will provide
p.001195: education and training in identifying and referring cases of domestic violence.
p.001195: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001195: to be appropriated
p.001195: $400,000 for each of the fiscal years 2008 though 2012.
p.001195: SEC. 1252. ø300d–52¿ STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC BRAIN INJURY.
p.001195: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001195: Living, may make grants to States and American Indian consortia for the purpose of carrying out projects
p.001195: to improve access to rehabilitation and other services regarding traumatic brain injury.
p.001195: (b) STATE ADVISORY BOARD.—
p.001195: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the State or American Indian
p.001195: consortium involved agrees to establish an advisory board within the ap- propriate health department of
p.001195: the State or American Indian consortium or within another department as designated by the chief executive officer
p.001195: of the State or American Indian consor- tium.
p.001195: (2) FUNCTIONS.—An advisory board established under paragraph (1) shall advise and make recommendations
p.001195: to the State or American Indian consortium on ways to improve serv- ices coordination regarding traumatic brain
p.001195: injury. Such advi- sory boards shall encourage citizen participation through the establishment of public
p.001195: hearings and other types of community outreach programs. In developing recommendations under this paragraph, such
p.001195: boards shall consult with Federal, State, and local governmental agencies and with citizens groups and other
p.001195: private entities.
p.001195: (3) COMPOSITION.—An advisory board established under paragraph (1) shall be composed of—
p.001195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: 1197
p.001197: PUBLIC HEALTH SERVICE ACT
p.001197: Sec. 1252
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p.001197: (1) IN GENERAL.—With respect to the costs to be incurred by a State or American Indian consortium in
p.001197: carrying out the purpose described in subsection (a), the Secretary may make a grant under such subsection only
p.001197: if the State or American In- dian consortium agrees to make available non-Federal con- tributions toward
p.001197: such costs in an amount that is not less than
p.001197: $1 for each $2 of Federal funds provided under the grant.
p.001197: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001197: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001197: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001197: not be included in determining the amount of such contributions.
p.001197: (d) APPLICATION FOR GRANT.—The Secretary may make a grant under subsection (a) only if an application for the
p.001197: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.001197: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
p.001197: out this section.
p.001197: (e) USE OF STATE AND AMERICAN INDIAN CONSORTIUM GRANTS.—
p.001197: (1) COMMUNITY SERVICES AND SUPPORTS.—A State or American Indian consortium shall (directly or
p.001197: through awards of contracts to nonprofit private entities) use amounts received under a grant under this section for
p.001197: the following:
p.001197: (A) To develop, change, or enhance community-based service delivery systems that include timely access to com-
p.001197: prehensive appropriate services and supports. Such service and supports—
p.001197: (i) shall promote full participation by individuals with traumatic brain injury and their families in deci- sion
p.001197: making regarding the services and supports; and
p.001197: (ii) shall be designed for children, youth, and adults with traumatic brain injury.
p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: Sec. 1252 PUBLIC HEALTH SERVICE ACT 1198
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p.001197:
p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
p.001197: support, peer mentoring, and parent to parent programs.
p.001197: (D) To develop individual and family service coordina- tion or case management systems.
p.001197: (E) To support other needs identified by the advisory board under subsection (b) for the State or
p.001197: American In- dian consortium involved.
p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
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p.001201: vided to individuals with traumatic brain injury by such sys- tem.
p.001201: (2) REPORT BY SECRETARY.—Not later than 1 year after the date of enactment of the Traumatic Brain Injury Reauthoriza-
p.001201: tion Act of 2014, the Secretary shall prepare and submit to the appropriate committees of Congress a report
p.001201: describing the services and activities carried out under this section during the period for which the report is being
p.001201: prepared.
p.001201: (i) DATA COLLECTION.—The Secretary shall facilitate agree- ments to coordinate the collection of data by
p.001201: agencies within the Department of Health and Human Services regarding protection and advocacy services.
p.001201: (j) TRAINING AND TECHNICAL ASSISTANCE.—
p.001201: (1) GRANTS.—For any fiscal year for which the amount ap- propriated to carry out this section is $6,000,000 or
p.001201: greater, the Secretary shall use 2 percent of such amount to make a grant to an eligible national
p.001201: association for providing for train- ing and technical assistance to protection and advocacy sys- tems.
p.001201: (2) DEFINITION.—In this subsection, the term ‘‘eligible na- tional association’’ means a national
p.001201: association with dem- onstrated experience in providing training and technical assist- ance to protection and
p.001201: advocacy systems.
p.001201: (k) SYSTEM AUTHORITY.—In providing services under this sec- tion, a protection and advocacy system shall
p.001201: have the same au- thorities, including access to records, as such system would have for purposes of
p.001201: providing services under subtitle C of title I of the Developmental Disabilities Assistance and Bill of Rights
p.001201: Act of 2000 (42 U.S.C. 15041 et seq.).
p.001201: (l) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001201: $4,000,000 for each of fiscal years 2020 through 2024.
p.001201: (m) DEFINITIONS.—In this section:
p.001201: (1) AMERICAN INDIAN CONSORTIUM.—The term ‘‘American Indian consortium’’ means a consortium established under
p.001201: sub- title C of title I of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C.
p.001201: 15041 et seq.).
p.001201: (2) PROTECTION AND ADVOCACY SYSTEM.—The term ‘‘protec- tion and advocacy system’’ means a protection and
p.001201: advocacy system established under subtitle C of title I of the Develop- mental Disabilities Assistance and
p.001201: Bill of Rights Act of 2000 (42 U.S.C. 15041 et seq.).
p.001201: (3) STATE.—The term ‘‘State’’, unless otherwise specified, means the several States of the United States,
p.001201: the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam,
p.001201: American Samoa, and the Com- monwealth of the Northern Mariana Islands.
p.001201: SEC. 1254. ø300d–54¿ STOP, OBSERVE, ASK, AND RESPOND TO HEALTH AND WELLNESS TRAINING PROGRAM.
p.001201: (a) IN GENERAL.—The Secretary shall establish a program to be known as the Stop, Observe, Ask, and
p.001201: Respond to Health and Wellness Training Program or the SOAR to Health and Wellness Training Program (in
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p.001205: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001205: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001205: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001205: private entities.
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001205: Sec. 1271 PUBLIC HEALTH SERVICE ACT 1206
p.001205:
p.001205: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001205: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005, and such
p.001205: sums as may be necessary for each of the fiscal years 2009 through 2012.
p.001205: PART G—POISON CONTROL
p.001205: SEC. 1271. ø300d–71¿ MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER AND OTHER COMMUNICATION CAPABILITIES.
p.001205: (a) IN GENERAL.—The Secretary—
p.001205: (1) shall provide coordination and assistance to poison con- trol centers for the establishment and maintenance of a
p.001205: nation- wide toll-free phone number, to be used to access such centers; and
p.001205:
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p.001205: (2) may provide coordination and assistance to poison con- trol centers and consult with professional organizations for
p.001205: the establishment, implementation, and maintenance of other com- munication technologies to be used to access such
p.001205: centers.
p.001205: (b) ROUTING CONTACTS WITH POISON CONTROL CENTERS.—Not later than 18 months after the date of enactment of this
p.001205: subsection, the Secretary shall coordinate with the Chairman of the Federal Communications Commission, to
p.001205: the extent technically and eco- nomically feasible, to ensure that communications with the na- tional
p.001205: toll-free number are routed to the appropriate poison control center based on the physical location of the contact
p.001205: rather than the area code of the contact device.
p.001205: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001205: $700,000 for each of fiscal years 2020 through 2024 for the establishment, implementa- tion, and maintenance
p.001205: activities carried out under subsections (a) and (b).
p.001205: SEC. 1272. ø300d–72¿ PROMOTING POISON CONTROL CENTER UTILIZA- TION.
p.001205: (a) IN GENERAL.—The Secretary shall carry out, and expand upon, a national media campaign to educate and
p.001205: support outreach to the public and health care providers about poisoning and toxic exposure prevention and
p.001205: the availability of poison control center re- sources in local communities and to conduct advertising campaigns
p.001205: concerning the nationwide toll-free number and other available communication technologies established,
p.001205: implemented, or main- tained under section 1271(a).
p.001205: (b) CONTRACT WITH ENTITY.—The Secretary may carry out subsection (a) by entering into contracts with one
p.001205: or more public or private entities, including nationally recognized organizations in the field of poison control and
p.001205: national media firms, for the devel- opment and implementation of a nationwide poisoning and toxic ex- posure
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p.001207: subsection (c) (or granted a waiver under subsection (d)) and professional organiza- tions in the field of
p.001207: poison control for the purposes of preventing, and providing treatment recommendations for, poisonings and toxic
p.001207: exposures and complying with the operational requirements needed to sustain the accreditation of the center under
p.001207: subsection (c).
p.001207: (b) ADDITIONAL USES OF FUNDS.—In addition to the purposes described in subsection (a), a poison center
p.001207: or professional organi- zation awarded a grant, contract, or cooperative agreement under such subsection
p.001207: may also use amounts received under such grant, contract, or cooperative agreement—
p.001207: (1) to research, establish, implement, and evaluate best practices in the United States for poisoning and toxic
p.001207: exposure prevention, poison control center outreach, and emergency pre- paredness and response programs;
p.001207: (2) to research, develop, implement, revise, and commu- nicate standard patient management guidelines for
p.001207: commonly encountered toxic exposures;
p.001207: (3) to improve national toxic exposure surveillance by en- hancing cooperative activities between poison
p.001207: control centers in the United States, the Centers for Disease Control and Preven- tion, and other government
p.001207: agencies as determined to be ap- propriate and nonduplicative by the Secretary;
p.001207: (4) to research, improve, and enhance the communications and response capability and capacity of the nation’s network
p.001207: of poison control centers to facilitate increased access to the cen- ters through the integration and
p.001207: modernization of the current poison control centers communications and data system, in- cluding enhancing the
p.001207: network’s telephony, Internet, data and social networking technologies;
p.001207: (5) to develop, support, and enhance technology and capa- bilities of professional organizations in the
p.001207: field of poison con- trol to collect national poisoning, toxic occurrence, and related public health data;
p.001207: (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected
p.001207: by organiza- tions described in paragraph (5);
p.001207: (7) to support and expand the toxicologic expertise within poison control centers; and
p.001207: (8) to improve the capacity of poison control centers to an- swer high volumes of contacts and Internet
p.001207: communications, and to sustain and enhance the poison control center’s network capability to respond during times
p.001207: of national crisis or other public health emergencies.
p.001207: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001207:
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p.001207: Sec. 1273 PUBLIC HEALTH SERVICE ACT 1208
p.001207:
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p.001209: alignment of such ac- tivities with the purposes provided under subsection (a);
p.001209: (2) a description of trends in volume of contacts to poison control centers;
p.001209: (3) a description of trends in poisonings and toxic expo- sures reported to poison control centers, as
p.001209: applicable and ap- propriate;
p.001209: (4) an assessment of the impact of the public awareness campaign, including any geographic variations;
p.001209: (5) a description of barriers, if any, preventing poison con- trol centers from achieving the purposes and
p.001209: programs under this section and sections 1271 and 1272;
p.001209: (6) a description of the standards for accreditation de- scribed in subsection (c), including any
p.001209: variations in those standards, and any efforts to create and maintain consistent standards across
p.001209: organizations that accredit poison control cen- ters; and
p.001209: (7) the number of and reason for any waivers provided under subsection (d).
p.001209: SEC. 1274. ø300d–74¿ RULE OF CONSTRUCTION.
p.001209: Nothing in this part may be construed to ease any restriction in Federal law applicable to the amount or
p.001209: percentage of funds ap- propriated to carry out this part that may be used to prepare or submit a report.
p.001209: PART H—TRAUMA SERVICE AVAILABILITY
p.001209:
p.001209:
p.001209:
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p.001209:
p.001209: January 30, 2020
p.001209: SEC. 1281. ø300d–81¿ GRANTS TO STATES.
p.001209: (a) ESTABLISHMENT.—To promote universal access to trauma care services provided by trauma centers and
p.001209: trauma-related physi- cian specialties, the Secretary shall provide funding to States to en- able such States to
p.001209: award grants to eligible entities for the pur- poses described in this section.
p.001209: (b) AWARDING OF GRANTS BY STATES.—Each State may award grants to eligible entities within the State for
p.001209: the purposes de- scribed in subparagraph (d).
p.001209: (c) ELIGIBILITY.—
p.001209: (1) IN GENERAL.—To be eligible to receive a grant under subsection (b) an entity shall—
p.001209: (A) be—
p.001209: (i) a public or nonprofit trauma center or consor- tium thereof that meets that requirements of para-
p.001209: graphs (1), (2), and (5) of section 1241(b);
p.001209: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001209:
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p.001209: Sec. 1281 PUBLIC HEALTH SERVICE ACT 1210
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p.001209: (b) shall carry out 1 or more of the following activities consistent with subsection (b):
p.001209: (1) Providing trauma centers with funding to support phy- sician compensation in trauma-related physician
p.001209: specialties where shortages exist in the region involved, with priority pro- vided to safety net trauma centers
p.001209: described in subsection (c)(1)(A)(ii).
p.001209: (2) Providing for individual safety net trauma center fiscal stability and costs related to having service that is
p.001209: available 24 hours a day, 7 days a week, with priority provided to safety net trauma centers described in
p.001209: subsection (c)(1)(A)(ii) located in urban, border, and rural areas.
p.001209: (3) Reducing trauma center overcrowding at specific trau- ma centers related to throughput of trauma patients.
p.001209: (4) Establishing new trauma services in underserved areas as defined by the State.
p.001209: (5) Enhancing collaboration between trauma centers and other hospitals and emergency medical services
p.001209: personnel re- lated to trauma service availability.
p.001209: (6) Making capital improvements to enhance access and expedite trauma care, including providing helipads and
p.001209: associ- ated safety infrastructure.
p.001209: (7) Enhancing trauma surge capacity at specific trauma centers.
p.001209: (8) Ensuring expedient receipt of trauma patients trans- ported by ground or air to the appropriate trauma
p.001209: center.
p.001209: (9) Enhancing interstate trauma center collaboration.
p.001209: (e) LIMITATION.—
p.001209: (1) IN GENERAL.—A State may use not more than 20 per- cent of the amount available to the State under
p.001209: this part for a fiscal year for administrative costs associated with awarding grants and related costs.
p.001209: (2) MAINTENANCE OF EFFORT.—The Secretary may not pro- vide funding to a State under this part unless the State agrees
p.001209: that such funds will be used to supplement and not supplant State funding otherwise available for the
p.001209: activities and costs described in this part.
p.001209: (f) DISTRIBUTION OF FUNDS.—The following shall apply with re- spect to grants provided in this part:
p.001209: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001211: 1211
p.001211: PUBLIC HEALTH SERVICE ACT
p.001211: Sec. 1291
p.001211:
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p.001225: health maintenance organization in such manner and with such frequency as the Secretary may by regulation
p.001225: prescribe. In deter- mining, for purposes of paragraph (2), whether an applicant would be able to complete a project
p.001225: or undertaking without the assistance applied for, the Secretary shall not consider any asset of the appli- cant the
p.001225: obligation of which for such undertaking or project would jeopardize the fiscal soundness of the applicant.
p.001225: (c) The Secretary shall by regulation establish standards and procedures for health systems agencies to
p.001225: follow in reviewing and commenting on applications for loans and loan guarantees under this title.
p.001225:
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p.001225: January 30, 2020
p.001225: ADMINISTRATION OF ASSISTANCE PROGRAMS
p.001225: SEC. 1307. ø300e–6¿ (a)(1) Each recipient of a loan or loan guarantee under this title shall keep such
p.001225: records as the Secretary shall prescribe, including records which fully disclose the amount and disposition
p.001225: by such recipient of the proceeds of the loan (di- rectly made or guaranteed), the total cost of the
p.001225: undertaking in connection with which the loan was given or used, the amount of that portion of the cost
p.001225: of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
p.001225: (2) The Secretary, or any of his duly authorized representa- tives, shall have access for the purpose
p.001225: of audit and examination to any books, documents, papers, and records of the recipients of a loan or
p.001225: loan guarantee under this title which relate to such as- sistance.
p.001225: (b) Upon expiration of the period for which a loan or loan guar- antee was provided an entity under this title,
p.001225: such entity shall make a full and complete report to the Secretary in such manner as he may by regulation
p.001225: prescribe. Each such report shall contain,
p.001225: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001225:
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p.001225: Sec. 1308 PUBLIC HEALTH SERVICE ACT 1226
p.001225: among such other matters as the Secretary may by regulation re- quire, descriptions of plans,
p.001225: developments, and operations relating to the matters referred to in section 1306(b)(3).
p.001225: (d) 2 An entity which provides health services to a defined pop- ulation on a prepaid basis and which has
p.001225: members who are enti- tled to insurance benefits under title XVIII of the Social Security Act or to
p.001225: medical assistance under a State plan approved under title XIX of such Act may be considered as a
p.001225: health maintenance organization for purposes of receiving assistance under this title if—
p.001225: (1) with respect to its members who are entitled to such insurance benefits or to such medical assistance it
p.001225: (A) provides health services in accordance with section 1301(b), except that
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p.001259: State Agency for the State in which the facility is located a statement which shall be in such form,
p.001259: and contain such information, as the Secretary may require to accurately show—
p.001259: (1) the financial operations of the facility, and
p.001259:
p.001259:
p.001259:
p.001259: January 30, 2020
p.001259: 2 So in law. The comma probably should follow the ending quotations.
p.001259: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001259:
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p.001259:
p.001261: 1261
p.001261: PUBLIC HEALTH SERVICE ACT
p.001261: Sec. 1627
p.001261:
p.001261: (2) the costs to the facility of providing health services in the facility and the charges made by the
p.001261: facility for providing such services,
p.001261: during the period with respect to which the statement is filed. (b)(1) Each entity receiving Federal assistance under
p.001261: this title
p.001261: shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount
p.001261: and disposition by such en- tity of the proceeds of such assistance, the total cost of the project in connection with
p.001261: which such assistance is given or used, the amount of that portion of the cost of the project
p.001261: supplied by other sources, and such other records as will facilitate an effective audit.
p.001261: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.001261: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.001261: records of such entities which in the opinion of the Secretary or the Comptroller General may be related or
p.001261: perti- nent to the assistance referred to in paragraph (1).
p.001261: (c) Each such entity shall file at least annually with the Sec- retary a statement which shall be in
p.001261: such form, and contain such information, as the Secretary may require to accurately show—
p.001261: (1) the financial operations of the facility constructed or modernized with such assistance, and
p.001261: (2) the costs to such facility of providing health services in such facility, and the charges made for such
p.001261: services, during the period with respect to which the statement is filed.
p.001261: TECHNICAL ASSISTANCE
p.001261: SEC. 1626. ø300s–5¿ The Secretary shall provide (either through the Department of Health, Education,
p.001261: and Welfare or by contract) all necessary technical and other nonfinancial assistance to any public or
p.001261: other entity which is eligible to apply for assist- ance under this title to assist such entity in developing
p.001261: applications to be submitted to the Secretary under section 1621 or 1642. The Secretary shall make every
p.001261: effort to inform eligible applicants of the availability of assistance under this title.
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p.001263: of the applicant’s application under section 1513(e), determine the need for each service or part pro-
p.001263: posed to be discontinued by the applicant, (ii) in the case of an ap- plication for the conversion of a facility,
p.001263: determine the need for each service which will be provided as a result of a conversion, and
p.001263: (iii) make a recommendation to the State Agency for the State in which the applicant is located respecting
p.001263: approval by the Secretary of the applicant’s application.
p.001263: (B) A State Agency which has received a recommendation from a health systems agency under subparagraph (A) respecting
p.001263: an ap- plication shall, after consideration of such recommendation, make a recommendation to the Secretary
p.001263: respecting the approval by the Secretary of the application. A State Agency’s recommendation under this
p.001263: subparagraph respecting the approval of an application
p.001263: (i) shall be based upon (I) the need for each service or part pro- posed to be discontinued by the
p.001263: applicant, (II) in the case of an ap- plication for the conversion of a facility, the need for each service
p.001263: which will be provided as a result of the conversion, and (III) such other criteria as the Secretary may
p.001263: prescribe, and (ii) shall be ac- companied by the health systems agency’s recommendation made with respect
p.001263: to the approval of the application.
p.001263: (C) In determining, under subparagraphs (A) and (B), the need for the service (or services) or part proposed to
p.001263: be discontinued or converted by an applicant for a grant, a health systems agency and State Agency shall give
p.001263: special consideration to the unmet needs and existing access patterns of urban or rural poverty populations.
p.001263: (3)(A) The Secretary may not approve an application of a hos-
p.001263: pital for a grant—
p.001263: (i) if a State Agency recommended that the application not be approved, or
p.001263: (ii) if the Secretary is unable to determine that the cost of providing inpatient health services in the health
p.001263: service area in which the applicant is located will be less than if the inpa- tient health services proposed to be
p.001263: discontinued were not dis- continued.
p.001263: (B) In considering applications of hospitals for grants the Sec- retary shall consider the recommendations of
p.001263: health systems agen- cies and State Agencies and shall give special consideration to ap- plications (i) which will
p.001263: assist health systems agencies and State Agencies to meet the goals in their health systems plans and State
p.001263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001265: 1265
p.001265: PUBLIC HEALTH SERVICE ACT
p.001265: Sec. 1642
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p.001267: (10) use such other authorities for programs respecting health information and health promotion, preventive
p.001267: health services, and education in the appropriate use of health care as are available and coordinate
p.001267: such use with programs con- ducted under this title; and
p.001267: (11) establish in the Office of the Assistant Secretary for Health an Office of Disease Prevention and Health
p.001267: Promotion, which shall—
p.001267: (A) coordinate all activities within the Department which relate to disease prevention, health promotion,
p.001267: pre- ventive health services, and health information and edu- cation with respect to the appropriate use
p.001267: of health care;
p.001267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001267:
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p.001267: Sec. 1702 PUBLIC HEALTH SERVICE ACT 1268
p.001267:
p.001267: (B) coordinate such activities with similar activities in the private sector;
p.001267: (C) establish a national information clearinghouse to facilitate the exchange of information concerning
p.001267: matters relating to health information and health promotion, pre- ventive health services (which may
p.001267: include information concerning models and standards for insurance coverage of such services), and education in
p.001267: the appropriate use of health care, to facilitate access to such information, and to assist in the analysis of
p.001267: issues and problems relating to such matters; and
p.001267: (D) support projects, conduct research, and dissemi- nate information relating to preventive medicine,
p.001267: health promotion, and physical fitness and sports medicine.
p.001267: The Secretary shall appoint a Director for the Office of Disease Prevention and Health Promotion
p.001267: established pursuant to para- graph (11) of this subsection. The Secretary shall administer this title in
p.001267: cooperation with health care providers, educators, voluntary organizations, businesses, and State and local
p.001267: health agencies in order to encourage the dissemination of health information and health promotion
p.001267: activities.
p.001267: (b) For the purpose of carrying out this section and sections 1702 through 1705, there are
p.001267: authorized to be appropriated
p.001267: $10,000,000 for fiscal year 1992, and such sums as may be nec- essary for each of the fiscal years 1993
p.001267: through 2002.
p.001267: (c) No grant may be made or contract entered into under this title unless an application therefor has
p.001267: been submitted to and ap- proved by the Secretary. Such an application shall be submitted in such form and
p.001267: manner and contain such information as the Sec- retary may prescribe. Contracts may be entered into
p.001267: under this title without regard to sections 3648 and 3709 of the Revised Stat- utes (31 U.S.C. 529; 41 U.S.C. 5).
p.001267:
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p.001267: January 30, 2020
p.001267:
p.001267: RESEARCH PROGRAMS
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p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
p.001273: (9) Carry out programs to improve access to health care services for individuals with limited proficiency in
p.001273: speaking the English language. Activities under the preceding sentence shall include developing and evaluating model
p.001273: projects.
p.001273: (10) Advise in matters related to the development, imple- mentation, and evaluation of health professions
p.001273: education in
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275:
p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
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p.001279: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001279: to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The
p.001279: authorization of appropriations established in the preceding sentence is in addition to any other authorization of
p.001279: appropriation that is available for such purpose.
p.001279: SEC. 1711. ø300u–16¿ ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION DASHBOARD.
p.001279: (a) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Secretary of Health
p.001279: and Human Services shall, in consultation with the Director of National Drug Control Policy, establish
p.001279: and periodically update, on the Internet website of the Department of Health and Human Services, a public
p.001279: information dashboard that—
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
p.001279:
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p.001279: Sec. 1801 PUBLIC HEALTH SERVICE ACT 1280
p.001279:
p.001279: (1) provides links to information on programs within the Department of Health and Human Services related
p.001279: to the re- duction of opioid and other substance use disorders;
p.001279: (2) provides access, to the extent practicable and appro- priate, to publicly available data, which may include
p.001279: data from agencies within the Department of Health and Human Serv- ices and—
p.001279: (A) other Federal agencies;
p.001279: (B) State, local, and Tribal governments;
p.001279: (C) nonprofit organizations;
p.001279: (D) law enforcement;
p.001279: (E) medical experts;
p.001279: (F) public health educators; and
p.001279: (G) research institutions regarding prevention, treat- ment, recovery, and other services for opioid and
p.001279: other substance use disorders;
p.001279: (3) provides data on substance use disorder prevention and treatment strategies in different regions of and
p.001279: populations in the United States;
p.001279: (4) identifies information on alternatives to controlled sub- stances for pain management, such as approaches
p.001279: studied by the National Institutes of Health Pain Consortium, the Na- tional Center for Complimentary and
p.001279: Integrative Health, and other institutes and centers at the National Institutes of Health, as
p.001279: appropriate; and
p.001279: (5) identifies guidelines and best practices for health care providers regarding treatment of substance use
p.001279: disorders.
p.001279: (b) CONTROLLED SUBSTANCE DEFINED.—In this section, the term ‘‘controlled substance’’ has the meaning
p.001279: given that term in section 102 of the Controlled Substances Act (21 U.S.C. 802).
p.001279: TITLE XVIII—PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND
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p.001281:
p.001281:
p.001281:
p.001281:
p.001281: January 30, 2020
p.001281: DUTIES OF THE COMMISSION
p.001281: SEC. 1802. ø300v–1¿ (a) STUDIES.—(1) The Commission shall undertake studies of the ethical and legal
p.001281: implications of—
p.001281: (A) the requirements for informed consent to participation in research projects and to otherwise undergo medical
p.001281: proce- dures;
p.001281: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001281:
p.001281:
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p.001281:
p.001281: Sec. 1802 PUBLIC HEALTH SERVICE ACT 1282
p.001281:
p.001281: (B) the matter of defining death, including the advisability of developing a uniform definition of death;
p.001281: (C) voluntary testing, counseling, and information and education programs with respect to genetic diseases
p.001281: and condi- tions, taking into account the essential equality of all human beings, born and unborn;
p.001281: (D) the differences in the availability of health services as determined by the income or residence of the persons
p.001281: receiving the services;
p.001281: (E) current procedures and mechanisms designed (i) to safeguard the privacy of human subjects of behavioral and
p.001281: bio- medical research, (ii) to ensure the confidentiality of individ- ually identifiable patient records,
p.001281: and (iii) to ensure appro- priate access of patients to information continued 2 in such records, 3 and
p.001281: (F) such other matters relating to medicine or biomedical or behavioral research as the President may
p.001281: designate for study by the Commission.
p.001281: The Commission shall determine the priority and order of the stud- ies required under this paragraph.
p.001281: (2) The Commission may undertake an investigation or study of any other appropriate matter which relates
p.001281: to medicine or bio- medical or behavioral research (including the protection of human subjects of
p.001281: biomedical or behavioral research) and which is con- sistent with the purposes of this title on its own
p.001281: initiative or at the request of the head of the Federal agency.
p.001281: (3) In order to avoid duplication of effort, the Commission may, in lieu of, or as part of, any study or investigation
p.001281: required or oth- erwise conducted under this subsection, use a study or investiga- tion conducted by
p.001281: another entity if the Commission sets forth its reasons for such use.
p.001281: (4) Upon the completion of each investigation or study under- taken by the Commission under this subsection
p.001281: (including a study or investigation which merely uses another study or investigation), it shall report its findings
p.001281: (including any recommendations for leg- islation or administrative action) to the President and the Congress and to
p.001281: each Federal agency to which a recommendation in the re- port applies.
p.001281: (b) RECOMMENDATIONS TO AGENCIES.—(1) Within 60 days of the date a Federal agency receives a
p.001281: recommendation from the Commission that the agency take any action with respect to its rules, policies,
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p.001283: Sec. 1804 PUBLIC HEALTH SERVICE ACT 1284
p.001283:
p.001283: (2) The Commission may procure temporary and intermittent services to the same extent as is authorized
p.001283: by section 3109(b) of title 5 of the United States Code, but at rates for individuals not to exceed
p.001283: the daily equivalent of the annual rate of basis pay in effect for grade GS–18 of the General Schedule.
p.001283: (3) Upon request of the Commission, the head of any Federal agency is authorized to detail, on a reimbursable
p.001283: basis, any of the personnel of such agency to the Commission to assist it in carrying out its duties under this title.
p.001283: (c) CONTRACTS.—The Commission, in performing its duties and functions under this title, may enter into contracts
p.001283: with appro- priate public or nonprofit private entities. The authority of the Commission to enter into
p.001283: such contracts is effective for any fiscal year only to such extent or in such amounts as are provided in ad-
p.001283: vance in appropriation Acts.
p.001283: (d) INFORMATION.—(1) The Commission may secure directly from any Federal agency information necessary to
p.001283: enable it to carry out this title. Upon request of the Chairman of the Commis- sion, the head of such agency shall
p.001283: furnish such information to the Commission.
p.001283: (2) The Commission shall promptly arrange for such security clearances for its members and appropriate
p.001283: staff as are necessary to obtain access to classified information needed to carry out its du- ties under this title.
p.001283: (3) The Commission shall not disclose any information reported to or otherwise obtained by the Commission which is
p.001283: exempt from disclosure under subsection (a) of section 552 of title 5, United States Code, by reason of
p.001283: paragraphs (4) and (6) of subsection (b) of such section.
p.001283: (e) SUPPORT SERVICES.—The Administrator of General Services shall provide to the Commission on a reimbursable
p.001283: basis such ad- ministrative support services as the Commission may request.
p.001283: AUTHORIZATION OF APPROPRIATIONS; TERMINATION OF COMMISSION
p.001283: SEC. 1804. ø300v–3¿ (a) AUTHORIZATIONS.—To carry out this title there are authorized to be appropriated
p.001283: $5,000,000 for the fis- cal year ending September 30, 1979, $5,000,000 for the fiscal year ending September
p.001283: 30, 1980, $5,000,000 for the fiscal year ending September 30, 1981, and $5,000,000 for the fiscal year ending
p.001283: Sep- tember 30, 1982.
p.001283: (b) FEDERAL ADVISORY COMMITTEE ACT; TERMINATION.—The Commission shall be subject to the Federal Advisory
p.001283: Committee Act, except that, under section 14(a)(1)(B) of such Act, the Commis- sion shall terminate on December 31,
p.001283: 1982.
p.001283: TITLE XIX—BLOCK GRANTS
p.001283: PART A—PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANT
p.001283:
p.001283:
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p.001283:
p.001283:
p.001283: January 30, 2020
p.001283: AUTHORIZATION OF APPROPRIATIONS
p.001283: SEC. 1901. ø300w¿ (a) For the purpose of allotments under sec- tion 1902, there are authorized to be appropriated
p.001283: $205,000,000 for
p.001283: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001283:
p.001283:
p.001283:
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p.001347: by the grantee in the area to be served, the population to which such services will be provided, how such
p.001347: services will be coordinated, integrated, and linked with other related programs and services and the
p.001347: source or sources of funding of such core services in the public and pri- vate sectors; or
p.001347: (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be
p.001347: provided and how the applicant will provide such services;
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001349: 1349
p.001349: PUBLIC HEALTH SERVICE ACT
p.001349: Sec. 2006
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p.001349: (6) a description of the manner in which adolescents need- ing services other than the services provided directly by
p.001349: the ap- plicant will be identified and how access and appropriate refer- ral to such other services (such as medicaid;
p.001349: licensed adoption agencies; maternity home services; public assistance; employ- ment services; child care
p.001349: services for adolescent parents; and other city, county, and State programs related to adolescent
p.001349: pregnancy) will be provided, including a description of a plan to coordinate such other services with
p.001349: the services supported under this title;
p.001349: (7) a description of the applicant’s capacity to continue services as Federal funds decrease and in the
p.001349: absence of Fed- eral assistance;
p.001349: (8) a description of the results expected from the provision of services, and the procedures to be used for evaluating
p.001349: those results;
p.001349: (9) a summary of the views of public agencies, providers of services, and the general public in the geographic
p.001349: area to be served, concerning the proposed use of funds provided for a demonstration project for services
p.001349: under this title and a de- scription of procedures used to obtain those views, and, in the case of applicants who
p.001349: propose to coordinate services adminis- tered by a State, the written comments of the appropriate State
p.001349: officials responsible for such services;
p.001349: (10) assurances that the applicant will have an ongoing quality assurance program;
p.001349: (11) assurances that, where appropriate, the applicant shall have a system for maintaining the
p.001349: confidentiality of pa- tient records in accordance with regulations promulgated by the Secretary;
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p.001381: ceeding for approval of the vaccine under section 351,
p.001381: (B) intentional and wrongful withholding of informa- tion relating to the safety or efficacy of the
p.001381: vaccine after its approval, or
p.001381: (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines,
p.001381: which activity related to the vaccine-related injury or death for which the civil action was brought.
p.001381: (e) EVIDENCE.—In any stage of a civil action, the Vaccine In- jury Table, any finding of fact or
p.001381: conclusion of law of the United States Claims Court or a special master in a proceeding on a peti- tion filed
p.001381: under section 2111 and the final judgment of the United States Claims Court and subsequent appellate review on such a
p.001381: pe- tition shall not be admissible.
p.001381: PART C—ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN THE UNITED STATES
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p.001381: January 30, 2020
p.001381:
p.001381: RECORDING AND REPORTING OF INFORMATION
p.001381: SEC. 2125. ø300aa–25¿ (a) GENERAL RULE.—Each health care provider who administers a vaccine set forth in the
p.001381: Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person’s permanent
p.001381: medical record (or in a permanent of- fice log or file to which a legal representative shall have
p.001381: access upon request) with respect to each such vaccine—
p.001381: (1) the date of administration of the vaccine,
p.001381: (2) the vaccine manufacturer and lot number of the vac- cine,
p.001381: (3) the name and address and, if appropriate, the title of the health care provider administering the
p.001381: vaccine, and
p.001381: (4) any other identifying information on the vaccine re- quired pursuant to regulations promulgated by
p.001381: the Secretary.
p.001381: (b) REPORTING.—
p.001381: (1) Each health care provider and vaccine manufacturer shall report to the Secretary—
p.001381: (A) the occurrence of any event set forth in the Vac- cine Injury Table, including the events set forth in
p.001381: section 2114(b) which occur within 7 days of the administration of any vaccine set forth in the Table or within such
p.001381: longer pe- riod as is specified in the Table or section,
p.001381: (B) the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer’s
p.001381: package insert, and
p.001381: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001381:
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p.001383: PUBLIC HEALTH SERVICE ACT
p.001383: Sec. 2126
p.001383:
p.001383: (C) such other matters as the Secretary may by regu- lation require.
p.001383: Reports of the matters referred to in subparagraphs (A) and
p.001383: (B) shall be made beginning 90 days after the effective date of this part. 25 The Secretary shall publish in the
p.001383: Federal Register as soon as practicable after such date a notice of the reporting requirement.
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p.001399: SEC. 2313. ø300cc–13¿ TERRY BEIRN COMMUNITY-BASED AIDS RE- SEARCH INITIATIVE.
p.001399: (a) IN GENERAL.—After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of
p.001399: Health, acting through the National Institute 3 of Allergy and Infectious Diseases, may make grants to public
p.001399: entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into
p.001399: contracts with public and private such entities, for the purpose of planning and conducting, in the
p.001399: community in- volved, clinical trials of experimental treatments for infection with the etiologic agent for such
p.001399: syndrome that are approved by the Commissioner of Food and Drugs for investigational use under reg- ulations
p.001399: issued under section 505 of the Federal Food, Drug, and Cosmetic Act.
p.001399: (b) REQUIREMENT OF CERTAIN PROJECTS.—
p.001399: (1) Financial assistance under subsection (a) shall include such assistance to community-based organizations and
p.001399: commu- nity health centers for the purpose of—
p.001399: (A) retaining appropriate medical supervision;
p.001399: (B) assisting with administration, data collection and record management; and
p.001399: (C) conducting training of community physicians, nurse practitioners, physicians’ assistants and other health
p.001399: professionals for the purpose of conducting clinical trials. (2)(A) Financial assistance under subsection
p.001399: (a) shall in- clude such assistance for demonstration projects designed to implement and conduct
p.001399: community-based clinical trials in order to provide access to the entire scope of communities af-
p.001399: fected by infections with the etiologic agent for acquired im- mune deficiency syndrome, including
p.001399: minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and
p.001399: individuals who are asymptomatic with
p.001399: respect to such infection.
p.001399:
p.001399:
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p.001399:
p.001399: January 30, 2020
p.001399: 3 So in law. Probably should be ‘‘acting through the Director of the National Institute’’. (Sec- tion
p.001399: 2617(b)(1) of Public Law 100–690 expressed the intent to so amend the provision; however, the amendment cannot be
p.001399: executed because the amendatory instructions are to strike ‘‘through the National Institutes of Allergy’’, and this
p.001399: term does not appear in subsection (a) (above).)
p.001399: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001401: PUBLIC HEALTH SERVICE ACT
p.001401: Sec. 2314
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p.001445: January 30, 2020
p.001445: designate a council under subparagraph (A), a chief elected official receiving a grant under section 2601(a)
p.001445: shall give priority to the designation of an existing entity that has demonstrated experience in planning
p.001445: for the HIV health care service needs within the eligible area and in the im- plementation of such plans
p.001445: in addressing those needs. Any existing entity so designated shall be expanded to include a broad
p.001445: representation of the full range of entities that provide such services within the geographic area to be
p.001445: served.
p.001445: (4) DUTIES.—The planning council established or des- ignated under paragraph (1) shall—
p.001445: (A) determine the size and demographics of the popu- lation of individuals with HIV/AIDS, as well as
p.001445: the size and demographics of the estimated population of individ- uals with HIV/AIDS who are unaware of their
p.001445: HIV status;
p.001445: (B) determine the needs of such population, with par- ticular attention to—
p.001445: (i) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services;
p.001445: (ii) disparities in access and services among af- fected subpopulations and historically underserved
p.001445: communities; and
p.001445: (iii) individuals with HIV/AIDS who do not know their HIV status;
p.001445: (C) establish priorities for the allocation of funds with- in the eligible area, including how best to meet each such
p.001445: priority and additional factors that a grantee should con- sider in allocating funds under a grant based on
p.001445: the—
p.001445: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under subpara- graph (A)) and
p.001445: the needs of such population (as deter- mined under subparagraph (B));
p.001445: (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and
p.001445: interventions, to the extent that data are reasonably available;
p.001445: (iii) priorities of the communities with HIV/AIDS for whom the services are intended;
p.001445: (iv) coordination in the provision of services to such individuals with programs for HIV prevention and
p.001445: for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for
p.001445: such abuse;
p.001445: (v) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001445: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001445: Act to cover health care costs of eligible individuals and families with HIV/AIDS; and
p.001445: (vi) capacity development needs resulting from disparities in the availability of HIV-related services
p.001445: in historically underserved communities;
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001445:
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p.001445: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1446
p.001445:
p.001445: (D) develop a comprehensive plan for the organization and delivery of health and support services described in
p.001445: section 2604 that—
p.001445: (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services
p.001445: and for informing the individuals of and ena- bling the individuals to utilize the services, giving par- ticular
p.001445: attention to eliminating disparities in access and services among affected subpopulations and his- torically
p.001445: underserved communities, and including dis- crete goals, a timetable, and an appropriate allocation of funds;
p.001445: (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (in- cluding
p.001445: outreach and early intervention) and for the prevention and treatment of substance abuse (includ- ing
p.001445: programs that provide comprehensive treatment services for such abuse);
p.001445: (iii) is compatible with any State or local plan for the provision of services to individuals with HIV/AIDS; and
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p.001445: January 30, 2020
p.001445: (iv) includes a strategy, coordinated as appro- priate with other community strategies and efforts, in-
p.001445: cluding discrete goals, a timetable, and appropriate funding, for identifying individuals with HIV/AIDS
p.001445: who do not know their HIV status, making such indi- viduals aware of such status, and enabling such indi-
p.001445: viduals to use the health and support services de- scribed in section 2604, with particular attention to re-
p.001445: ducing barriers to routine testing and disparities in access and services among affected subpopulations and
p.001445: historically underserved communities;
p.001445: (E) assess the efficiency of the administrative mecha- nism in rapidly allocating funds to the areas of
p.001445: greatest need within the eligible area, and at the discretion of the planning council, assess the
p.001445: effectiveness, either directly or through contractual arrangements, of the services offered in meeting the
p.001445: identified needs;
p.001445: (F) participate in the development of the statewide co- ordinated statement of need initiated by the State
p.001445: public health agency responsible for administering grants under part B;
p.001445: (G) establish methods for obtaining input on commu- nity needs and priorities which may include public
p.001445: meet- ings (in accordance with paragraph (7)), conducting focus groups, and convening ad-hoc panels; and
p.001445: (H) coordinate with Federal grantees that provide HIV-related services within the eligible area.
p.001445: (5) CONFLICTS OF INTEREST.—
p.001445: (A) IN GENERAL.—The planning council under para- graph (1) may not be directly involved in the
p.001445: administra- tion of a grant under section 2601(a). With respect to com- pliance with the preceding sentence, the
p.001445: planning council may not designate (or otherwise be involved in the selec-
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001447: PUBLIC HEALTH SERVICE ACT
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p.001455: made aware of their status, including the number who test positive; and
p.001455: (iii) of those individuals described in clause (ii), the number who have been referred to appropriate
p.001455: treatment and care.
p.001455: (B) DEMONSTRATED NEED.—The factors considered by the Secretary in determining whether an eligible area has a
p.001455: demonstrated need for purposes of paragraph (1)(B) may include any or all of the following:
p.001455: (i) The unmet need for such services, as deter- mined under section 2602(b)(4) or other community input
p.001455: process as defined under section 2609(d)(1)(A).
p.001455: (ii) An increasing need for HIV/AIDS-related serv- ices, including relative rates of increase in the number of cases of
p.001455: HIV/AIDS.
p.001455: (iii) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging sub-
p.001455: populations.
p.001455: (iv) The current prevalence of HIV/AIDS.
p.001455: (v) Relevant factors related to the cost and com- plexity of delivering health care to individuals with
p.001455: HIV/AIDS in the eligible area.
p.001455: (vi) The impact of co-morbid factors, including co- occurring conditions, determined relevant by the Sec-
p.001455: retary.
p.001455: (vii) The prevalence of homelessness.
p.001455: (viii) The prevalence of individuals described under section 2602(b)(2)(M).
p.001455: (ix) The relevant factors that limit access to health care, including geographic variation, adequacy
p.001455: of health insurance coverage, and language barriers.
p.001455: (x) The impact of a decline in the amount received pursuant to subsection (a) on services available to all
p.001455: individuals with HIV/AIDS identified and eligible under this title.
p.001455: (C) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this subsection to an eligible area to
p.001455: address the decline or disruption of all EMA-provided serv- ices related to the decline in the amounts received
p.001455: pursu- ant to subsection (a) consistent with the grant award for the eligible area for fiscal year 2006, to
p.001455: the extent that the factor under subparagraph (B)(x) (relating to a decline in funding) applies to the eligible
p.001455: area.
p.001455: (D) INCREASED ADJUSTMENT FOR CERTAIN AREAS PRE- VIOUSLY USING CODE-BASED REPORTING.—For purposes of this
p.001455: subsection for each of fiscal years 2010 through 2012, the Secretary shall deem the applicable number of living
p.001455: cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for Disease Control and
p.001455: Preven- tion to be 3 percent higher than the actual number if the
p.001455: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001455:
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p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001461: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001461: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, the
p.001461: chief elected official of an eligible area, in accordance with the established priorities of the planning
p.001461: council, shall for each of such populations in the eligible area use, from the grants made for the area under
p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
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p.001463: PUBLIC HEALTH SERVICE ACT
p.001463: Sec. 2605
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p.001463: January 30, 2020
p.001463: (C) other types of program support such as quality as- surance, quality control, and related activities.
p.001463: (5) CLINICAL QUALITY MANAGEMENT.—
p.001463: (A) REQUIREMENT.—The chief elected official of an eli- gible area that receives a grant under this subpart
p.001463: shall provide for the establishment of a clinical quality manage- ment program to assess the extent to which
p.001463: HIV health services provided to patients under the grant are con- sistent with the most recent Public
p.001463: Health Service guide- lines for the treatment of HIV/AIDS and related opportun- istic infection, and as
p.001463: applicable, to develop strategies for ensuring that such services are consistent with the guide- lines for
p.001463: improvement in the access to and quality of HIV health services.
p.001463: (B) USE OF FUNDS.—
p.001463: (i) IN GENERAL.—From amounts received under a grant awarded under this subpart for a fiscal year, the chief
p.001463: elected official of an eligible area may use for ac- tivities associated with the clinical quality manage- ment
p.001463: program required in subparagraph (A) not to ex- ceed the lesser of—
p.001463: (I) 5 percent of amounts received under the grant; or
p.001463: (II) $3,000,000.
p.001463: (ii) RELATION TO LIMITATION ON ADMINISTRATIVE EXPENSES.—The costs of a clinical quality manage- ment
p.001463: program under subparagraph (A) may not be considered administrative expenses for purposes of the limitation
p.001463: established in paragraph (1).
p.001463: (i) CONSTRUCTION.—A chief elected official may not use amounts received under a grant awarded under
p.001463: this subpart to purchase or improve land, or to purchase, construct, or perma- nently improve (other
p.001463: than minor remodeling) any building or other facility, or to make cash payments to intended recipients
p.001463: of services.
p.001463: SEC. 2605. ø300ff–15¿ APPLICATION.
p.001463: (a) IN GENERAL.—To be eligible to receive a grant under sec- tion 2601, an eligible area shall prepare
p.001463: and submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001463: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001463: shall require, in- cluding assurances adequate to ensure—
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p.001463: Sec. 2605 PUBLIC HEALTH SERVICE ACT 1464
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p.001463: January 30, 2020
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p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
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p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
p.001473: State shall for each of such populations in the eligible area use, from the grants made for the area
p.001473: under section 2601(a) for a fiscal year, not less than the percentage constituted by the ratio of the
...

p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001475:
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p.001475: Sec. 2613 PUBLIC HEALTH SERVICE ACT 1476
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p.001475: access and services and those who reside in historically underserved communities;
p.001475: (B) the service plan established under subsection (c)(2) by such consortium is consistent with the comprehensive
p.001475: plan under section 2617(b)(4) and addresses the special care and service needs of the populations and
p.001475: subpopula- tions identified under subparagraph (A); and
p.001475: (C) except as provided in paragraph (2), the consor- tium will be a single coordinating entity that will
p.001475: integrate the delivery of services among the populations and sub- populations identified under subparagraph
p.001475: (A).
p.001475: (2) EXCEPTION.—Subparagraph (C) of paragraph (1) shall not apply to any applicant consortium that the
p.001475: State deter- mines will operate in a community or locality in which it has been demonstrated by the
p.001475: applicant consortium that—
p.001475: (A) subpopulations exist within the community to be served that have unique service requirements; and
p.001475: (B) such unique service requirements cannot be ade- quately and efficiently addressed by a single
p.001475: consortium serving the entire community or locality.
p.001475: (c) APPLICATION.—
p.001475: (1) IN GENERAL.—To receive assistance from the State under subsection (a), a consortium shall prepare and submit
p.001475: to the State, an application that—
p.001475: (A) demonstrates that the consortium includes agen- cies and community-based organizations—
p.001475: (i) with a record of service to populations and sub- populations with HIV/AIDS requiring care within the
p.001475: community to be served; and
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p.001477: (iv) assurances that the assessment of service needs and the planning of the delivery of services will
p.001477: include participation by individuals with HIV/AIDS;
p.001477: (C) demonstrates that adequate planning has occurred to meet the special needs of families with HIV/AIDS, in-
p.001477: cluding family centered and youth centered care;
p.001477: (D) demonstrates that the consortium has created a mechanism to evaluate periodically—
p.001477: (i) the success of the consortium in responding to identified needs; and
p.001477: (ii) the cost-effectiveness of the mechanisms em- ployed by the consortium to deliver comprehensive care;
p.001477: (E) demonstrates that the consortium will report to the State the results of the evaluations described
p.001477: in sub- paragraph (D) and shall make available to the State or the Secretary, on request, such data and
p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
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p.001479: to establish a program under section 2612(b)(3)(B) to provide therapeutics to treat HIV/AIDS or prevent the
p.001479: serious deterioration of health aris- ing from HIV/AIDS in eligible individuals, including measures for the
p.001479: prevention and treatment of opportunistic infections.
p.001479: (b) ELIGIBLE INDIVIDUAL.—To be eligible to receive assistance from a State under this section an individual
p.001479: shall—
p.001479: (1) have a medical diagnosis of HIV/AIDS; and
p.001479: (2) be a low-income individual, as defined by the State.
p.001479: (c) STATE DUTIES.—In carrying out this section the State shall—
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p.001479: January 30, 2020
p.001479: (1) ensure that the therapeutics included on the list of classes of core antiretroviral therapeutics
p.001479: established by the Secretary under subsection (e) are, at a minimum, the treat- ments provided by the State
p.001479: pursuant to this section;
p.001479: (2) provide assistance for the purchase of treatments deter- mined to be eligible under paragraph (1), and the
p.001479: provision of such ancillary devices that are essential to administer such treatments;
p.001479: (3) provide outreach to individuals with HIV/AIDS, and as appropriate to the families of such individuals;
p.001479: (4) facilitate access to treatments for such individuals;
p.001479: (5) document the progress made in making therapeutics described in subsection (a) available to individuals
p.001479: eligible for assistance under this section; and
p.001479: (6) encourage, support, and enhance adherence to and com- pliance with treatment regimens, including related
p.001479: medical monitoring.
p.001479: Of the amount reserved by a State for a fiscal year for use under this section, the State may not
p.001479: use more than 5 percent to carry
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001479:
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p.001479: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1480
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p.001479: January 30, 2020
p.001479:
p.001479: out services under paragraph (6), except that the percentage appli- cable with respect to such paragraph is 10
p.001479: percent if the State demonstrates to the Secretary that such additional services are es- sential and in no way
p.001479: diminish access to the therapeutics described in subsection (a).
p.001479: (d) DUTIES OF THE SECRETARY.—In carrying out this section, the Secretary shall review the current
p.001479: status of State drug reim- bursement programs established under section 2612(2) and assess barriers to the
p.001479: expanded availability of the treatments described in subsection (a). The Secretary shall also examine the
p.001479: extent to which States coordinate with other grantees under this title to re- duce barriers to the expanded
p.001479: availability of the treatments de- scribed in subsection (a).
p.001479: (e) LIST OF CLASSES OF CORE ANTIRETROVIRAL THERA- PEUTICS.—For purposes of subsection (c)(1),
p.001479: the Secretary shall de- velop and maintain a list of classes of core antiretroviral thera- peutics, which
p.001479: list shall be based on the therapeutics included in the guidelines of the Secretary known as the
p.001479: Clinical Practice Guidelines for Use of HIV/AIDS Drugs, relating to drugs needed to manage symptoms associated with
p.001479: HIV. The preceding sentence does not affect the authority of the Secretary to modify such Guide- lines.
p.001479: (f) USE OF HEALTH INSURANCE AND PLANS.—
p.001479: (1) IN GENERAL.—In carrying out subsection (a), a State may expend a grant under section 2611 to
p.001479: provide the thera- peutics described in such subsection by paying on behalf of in- dividuals with HIV/AIDS the
...

p.001481: quested, and the number of individuals and families receiving such services, that shall include—
p.001481: (A) a description of the types of programs operated or funded by the State for the provision of HIV-related
p.001481: serv- ices during the year preceding the year for which the grant is requested and the methods utilized by the
p.001481: State to fi- nance such programs;
p.001481: (B) an accounting of the amount of funds that the State has expended for such services and programs during the
p.001481: year preceding the year for which the grant is re- quested; and
p.001481: (C) information concerning—
p.001481: (i) the number of individuals to be served with as- sistance provided under the grant;
p.001481: (ii) demographic data on the population of the in- dividuals to be served;
p.001481: (iii) the average cost of providing each category of HIV-related health services and the extent to which such
p.001481: cost is paid by third-party payors; and
p.001481: (iv) the aggregate amounts expended for each such category of services;
p.001481: (2) a determination of the size and demographics of the population of individuals with HIV/AIDS in the State;
p.001481: (3) a determination of the needs of such population, with particular attention to—
p.001481: (A) individuals with HIV/AIDS who know their HIV status and are not receiving HIV-related services; and
p.001481: (B) disparities in access and services among affected subpopulations and historically underserved
p.001481: communities;
p.001481: (4) the designation of a lead State agency that shall—
p.001481: (A) administer all assistance received under section 2611;
p.001481: (B) conduct the needs assessment and prepare the State plan under paragraph (3);
p.001481: (C) prepare all applications for assistance under sec- tion 2611;
p.001481: (D) receive notices with respect to programs under this title;
p.001481: (E) every 2 years, collect and submit to the Secretary all audits, consistent with Office of
p.001481: Management and Budget circular A133, from grantees within the State, in- cluding audits regarding funds
p.001481: expended in accordance with section 2611; and
p.001481: (F) carry out any other duties determined appropriate by the Secretary to facilitate the coordination of programs under
p.001481: this title.
p.001481: (5) a comprehensive plan that describes the organization and delivery of HIV health care and support
p.001481: services to be funded with assistance received under section 2611 that shall include a description of the
p.001481: purposes for which the State in- tends to use such assistance, and that—
p.001481: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001481:
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p.001481: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1482
p.001481:
p.001481: (A) 7 establishes priorities for the allocation of funds within the State based on—
p.001481: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under para- graph (2))
p.001481: and the needs of such population (as deter- mined under paragraph (3));
p.001481: (ii) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001481: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001481: Act to cover health care costs of eligible individuals and families with HIV/AIDS;
p.001481: (iii) capacity development needs resulting from disparities in the availability of HIV-related services
p.001481: in historically underserved communities and rural communities; and
p.001481: (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of
p.001481: greatest need within the State;
p.001481: (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and
p.001481: for informing the individuals of and enabling the indi- viduals to utilize the services, giving particular
p.001481: attention to eliminating disparities in access and services among af- fected subpopulations and historically
p.001481: underserved commu- nities, and including discrete goals, a timetable, and an ap- propriate allocation of funds;
p.001481: (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention
p.001481: (including outreach and early intervention) and for the prevention and treatment of substance abuse
p.001481: (including programs that provide comprehensive treatment services for such abuse);
p.001481: (D) describes the services and activities to be provided and an explanation of the manner in which the
p.001481: elements of the program to be implemented by the State with such assistance will maximize the quality of
p.001481: health and support services available to individuals with HIV/AIDS through- out the State;
p.001481: (E) provides a description of the manner in which services funded with assistance provided under section
p.001481: 2611 will be coordinated with other available related serv- ices for individuals with HIV/AIDS;
p.001481: (F) provides a description of how the allocation and utilization of resources are consistent with the
p.001481: statewide coordinated statement of need (including traditionally un- derserved populations and subpopulations)
p.001481: developed in
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p.001481: January 30, 2020
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p.001483: January 30, 2020
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p.001483: health and support services provided by entities that re- ceive funds from the State under section 2611;
p.001483: (D) the State will permit and cooperate with any Fed- eral investigations undertaken regarding programs con-
p.001483: ducted under section 2611;
p.001483: (E) the State will maintain HIV-related activities at a level that is equal to not less than the level of
p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
p.001483: (E) describing efforts to remove legal barriers, includ- ing State laws and regulations, to routine testing.
p.001483: (c) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001483: SERVICES.—
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001485: 1485
p.001485: PUBLIC HEALTH SERVICE ACT
p.001485: Sec. 2617
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p.001485: January 30, 2020
p.001485: (1) IN GENERAL.—The Secretary may not make a grant under section 2611 to a State unless the State provides
p.001485: assur- ances that in the provision of services with assistance provided under the grant—
p.001485: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the pro-
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p.001493: activities that include routine grant administration and monitoring activities, including a clinical quality
p.001493: manage- ment program under subparagraph (E).
p.001493: (D) SUBCONTRACTOR ADMINISTRATIVE COSTS.—For the purposes of this paragraph, subcontractor administrative
p.001493: activities include—
p.001493: (i) usual and recognized overhead, including estab- lished indirect rates for agencies;
p.001493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001495: 1495
p.001495: PUBLIC HEALTH SERVICE ACT
p.001495: Sec. 2618
p.001495:
p.001495: (ii) management oversight of specific programs funded under this title; and
p.001495: (iii) other types of program support such as qual- ity assurance, quality control, and related activities.
p.001495: (E) CLINICAL QUALITY MANAGEMENT.—
p.001495: (i) REQUIREMENT.—Each State that receives a grant under section 2611 shall provide for the estab-
p.001495: lishment of a clinical quality management program to assess the extent to which HIV health services pro- vided
p.001495: to patients under the grant are consistent with the most recent Public Health Service guidelines for the
p.001495: treatment of HIV/AIDS and related opportunistic infection, and as applicable, to develop strategies for
p.001495: ensuring that such services are consistent with the guidelines for improvement in the access to and qual- ity of
p.001495: HIV health services.
p.001495: (ii) USE OF FUNDS.—
p.001495: (I) IN GENERAL.—From amounts received under a grant awarded under section 2611 for a fiscal year,
p.001495: a State may use for activities associ- ated with the clinical quality management pro- gram required in
p.001495: clause (i) not to exceed the lesser of—
p.001495: (aa) 5 percent of amounts received under the grant; or
p.001495: (bb) $3,000,000.
p.001495: (II) RELATION TO LIMITATION ON ADMINISTRA- TIVE EXPENSES.—The costs of a clinical quality management
p.001495: program under clause (i) may not be considered administrative expenses for purposes of the limitation
p.001495: established in subparagraph (A).
p.001495: (4) LIMITATION ON USE OF FUNDS.—Except as provided in paragraph (5), a State may not use more than a total of
p.001495: 15 per- cent of amounts received under a grant awarded under section 2611 for the purposes described in paragraphs (2)
p.001495: and (3).
p.001495: (5) EXCEPTION.—With respect to a State that receives the minimum allotment under subsection (a)(1) for a
p.001495: fiscal year, such State, from the amounts received under a grant awarded under section 2611 for such fiscal year
p.001495: for the activities de- scribed in paragraphs (2) and (3), may, notwithstanding para- graphs (2) through
p.001495: (4) 12, use not more than that amount re- quired to support one full-time-equivalent employee.
p.001495: (6) CONSTRUCTION.—A State may not use amounts re- ceived under a grant awarded under section 2611 to
p.001495: purchase or improve land, or to purchase, construct, or permanently im- prove (other than minor remodeling) any
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p.001495: (b) DEMONSTRATED NEED.—The factors considered by the Sec- retary in determining whether an eligible area has a
p.001495: demonstrated need for purposes of subsection (a)(1) may include any or all of the following:
p.001495: (1) The unmet need for such services, as determined under section 2617(b).
p.001495: (2) An increasing need for HIV/AIDS-related services, in- cluding relative rates of increase in the
p.001495: number of cases of HIV/AIDS.
p.001495: (3) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging subpopulations.
p.001495: (4) The current prevalence of HIV/AIDS.
p.001495: (5) Relevant factors related to the cost and complexity of delivering health care to individuals with HIV/AIDS
p.001495: in the eli- gible area.
p.001495: (6) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.
p.001495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001497: 1497
p.001497: PUBLIC HEALTH SERVICE ACT
p.001497: Sec. 2621
p.001497:
p.001497: (7) The prevalence of homelessness.
p.001497: (8) The prevalence of individuals described under section 2602(b)(2)(M).
p.001497: (9) The relevant factors that limit access to health care, in- cluding geographic variation, adequacy of health
p.001497: insurance cov- erage, and language barriers.
p.001497: (10) The impact of a decline in the amount received pursu- ant to section 2618 on services available to all individuals
p.001497: with HIV/AIDS identified and eligible under this title.
p.001497: (c) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this section to a State to
p.001497: address the decline in serv- ices related to the decline in the amounts received pursuant to sec- tion 2618
p.001497: consistent with the grant award to the State for fiscal year 2006, to the extent that the factor under
p.001497: subsection (b)(10) (re- lating to a decline in funding) applies to the State.
p.001497: (d) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001497: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001497: shall include information detail- ing—
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p.001497: (1) the total amount of supplemental funds available under
p.001497: this section for the year involved;
p.001497: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of section
p.001497: 2618(a)(2);
p.001497: (3) the amount of supplemental funds disbursed pursuant to subsection (c);
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p.001517: applicant for the grant agrees that—
p.001517: (1) the applicant will not expend amounts received pursu- ant to this part for any purpose other than
p.001517: the purposes de- scribed in the subpart under which the grant involved is made;
p.001517: (2) the applicant will establish such procedures for fiscal control and fund accounting as may be
p.001517: necessary to ensure proper disbursement and accounting with respect to the grant;
p.001517: (3) the applicant will not expend more than 10 percent of the grant for administrative expenses
p.001517: with respect to the grant, including planning and evaluation, except that the costs of a clinical quality
p.001517: management program under paragraph (5) may not be considered administrative expenses for purposes of such limitation;
p.001517: (4) the applicant will submit evidence that the proposed program is consistent with the statewide
p.001517: coordinated state- ment of need and agree to participate in the ongoing revision of such statement of need;
p.001517: and
p.001517: (5) the applicant will provide for the establishment of a clinical quality management program—
p.001517: (A) to assess the extent to which medical services funded under this title that are provided to
p.001517: patients are consistent with the most recent Public Health Service guidelines for the treatment of
p.001517: HIV/AIDS and related op- portunistic infections, and as applicable, to develop strate- gies for ensuring that such
p.001517: services are consistent with the guidelines; and
p.001517: (B) to ensure that improvements in the access to and quality of HIV health services are addressed.
p.001517: SEC. 2665. ø300ff–65¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001517: The Secretary may not make a grant under this part unless—
p.001517: (1) an application for the grant is submitted to the Sec- retary containing agreements and assurances in
p.001517: accordance with this part and containing the information specified in sec- tion 2664(a)(1);
p.001517: (2) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001517: the Secretary; and
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p.001517: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001517: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001517: SEC. 2666. ø300ff–66¿ PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
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p.001519: (2) The applicant will participate in the statewide coordi- nated statement of need under part B (where it has
p.001519: been initi- ated by the public health agency responsible for administering grants under part B) and in revisions of
p.001519: such statement.
p.001519: (3) The applicant will every 2 years submit to the lead State agency under section 2617(b)(4) audits
p.001519: regarding funds expended in accordance with this title and shall include nec- essary client-level data to
p.001519: complete unmet need calculations and Statewide coordinated statements of need process.
p.001519: (d) ADMINISTRATION; APPLICATION.—A grant may only be awarded to an entity under subsection (a) if an
p.001519: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001519: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001519: be nec- essary to carry out this section. Such application shall include the following:
p.001519: (1) Information regarding how the expected expenditures of the grant are related to the planning process
p.001519: for localities funded under part A (including the planning process outlined in section 2602) and for States
p.001519: funded under part B (including the planning process outlined in section 2617(b)).
p.001519: (2) A specification of the expected expenditures and how those expenditures will improve overall patient
p.001519: outcomes, as outlined as part of the State plan (under section 2617(b)) or through additional outcome
p.001519: measures.
p.001519: (e) ANNUAL REVIEW OF PROGRAMS; EVALUATIONS.—
p.001519: (1) REVIEW REGARDING ACCESS TO AND PARTICIPATION IN PROGRAMS.—With respect to a grant under
p.001519: subsection (a) for an entity for a fiscal year, the Secretary shall, not later than 180 days after the
p.001519: end of the fiscal year, provide for the con- duct and completion of a review of the operation during
p.001519: the year of the program carried out under such subsection by the entity. The purpose of such review shall be
p.001519: the development of recommendations, as appropriate, for improvements in the fol- lowing:
p.001519: (A) Procedures used by the entity to allocate opportu- nities and services under subsection (a) among patients
p.001519: of the entity who are women, infants, children, or youth.
p.001519: (B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
p.001519: (2) EVALUATIONS.—— 14The Secretary shall, directly or through contracts with public and private
p.001519: entities, provide for evaluations of programs carried out pursuant to subsection (a).
p.001519: (f) ADMINISTRATIVE EXPENSES.—
p.001519: (1) LIMITATION.—A grantee may not use more than 10 per- cent of amounts received under a grant awarded under
p.001519: this section for administrative expenses.
p.001519:
p.001519:
p.001519:
p.001519: January 30, 2020
p.001519: 14 Dash so in law.
p.001519:
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001519:
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p.001527: $13,650,000 for fiscal year 2010, $14,333,000 for fiscal year
p.001527:
p.001527:
p.001527:
p.001527: January 30, 2020
p.001527: 15 So in law. See section 402(b)(2) of Public Law 106–345 (114 Stat. 1349).
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527:
p.001529: 1529
p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
p.001529:
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001529:
p.001529: Sec. 2693 PUBLIC HEALTH SERVICE ACT 1530
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p.001529:
p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
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p.001555: January 30, 2020
p.001555:
p.001555: wards provided under the project reflect the expected level of participation in the wellness program involved
p.001555: and the anticipated effect the program will have on utilization or medical claim costs.
p.001555: (m) REPORT.—
p.001555: (1) IN GENERAL.—Not later than 3 years after the date of enactment of the Patient Protection and
p.001555: Affordable Care Act, the Secretary, in consultation with the Secretary of the Treas- ury and the Secretary of
p.001555: Labor, shall submit a report to the appropriate committees of Congress concerning—
p.001555: (A) the effectiveness of wellness programs (as defined in subsection (j)) in promoting health and
p.001555: preventing dis- ease;
p.001555: (B) the impact of such wellness programs on the ac- cess to care and affordability of coverage for
p.001555: participants and non-participants of such programs;
p.001555: (C) the impact of premium-based and cost-sharing in- centives on participant behavior and the role of
p.001555: such pro- grams in changing behavior; and
p.001555: (D) the effectiveness of different types of rewards.
p.001555: (2) DATA COLLECTION.—In preparing the report described in paragraph (1), the Secretaries shall gather relevant
p.001555: informa- tion from employers who provide employees with access to wellness programs, including State and
p.001555: Federal agencies.
p.001555: (n) REGULATIONS.—Nothing in this section shall be construed as prohibiting the Secretaries of Labor,
p.001555: Health and Human Serv- ices, or the Treasury from promulgating regulations in connection with this section.
p.001555: SEC. 2706. ø300gg–5¿ NON-DISCRIMINATION IN HEALTH CARE.
p.001555: (a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001555: coverage shall not discriminate with respect to participation under the plan or coverage against any health
p.001555: care provider who is acting within the scope of that provider’s license or certification under applicable State
p.001555: law. This section shall not require that a group health plan or health insurance issuer contract with
p.001555: any health care provider willing to abide by the terms and conditions for participation estab- lished by the plan
p.001555: or issuer. Nothing in this section shall be con- strued as preventing a group health plan, a health
p.001555: insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance
p.001555: measures.
p.001555: (b) INDIVIDUALS.—The provisions of section 1558 of the Patient Protection and Affordable Care Act (relating to
p.001555: non-discrimination) shall apply with respect to a group health plan or health insurance issuer offering group or
p.001555: individual health insurance coverage.
p.001555: SEC. 2707. ø300gg–6¿ COMPREHENSIVE HEALTH INSURANCE COV- ERAGE.
p.001555: (a) COVERAGE FOR ESSENTIAL HEALTH BENEFITS PACKAGE.—A health insurance issuer that offers health insurance
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p.001559: and shall be suf- ficient to reasonably inform employers, or individuals, as appli- cable, of their rights and
p.001559: obligations under the health insur- ance coverage.
p.001559: (3) EXCEPTION.—An issuer is not required under this sec- tion to disclose any information that is
p.001559: proprietary and trade secret information under applicable law.
p.001559: Subpart II—Improving Coverage 8
p.001559: SEC. 2711. ø300gg–11¿ NO LIFETIME OR ANNUAL LIMITS.
p.001559: (a) PROHIBITION.—
p.001559: (1) IN GENERAL.—A group health plan and a health insur- ance issuer offering group or individual health
p.001559: insurance cov- erage may not establish—
p.001559: (A) lifetime limits on the dollar value of benefits for any participant or beneficiary; or
p.001559: (B) except as provided in paragraph (2), annual limits on the dollar value of benefits for any participant or bene-
p.001559: ficiary.
p.001559: (2) ANNUAL LIMITS PRIOR TO 2014.—With respect to plan years beginning prior to January 1, 2014, a group health
p.001559: plan and a health insurance issuer offering group or individual health insurance coverage may only
p.001559: establish a restricted an- nual limit on the dollar value of benefits for any participant or beneficiary with
p.001559: respect to the scope of benefits that are essen- tial health benefits under section 1302(b) of the Patient Protec- tion
p.001559: and Affordable Care Act, as determined by the Secretary. In defining the term ‘‘restricted annual limit’’ for
p.001559: purposes of the preceding sentence, the Secretary shall ensure that access to needed services is made
p.001559: available with a minimal impact on premiums.
p.001559:
p.001559:
p.001559:
p.001559: January 30, 2020
p.001559: 8 There is a subpart 2 (arabic 2) beginning with section 2722.
p.001559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001561: 1561
p.001561: PUBLIC HEALTH SERVICE ACT
p.001561: Sec. 2713
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p.001561: January 30, 2020
p.001561: (b) PER BENEFICIARY LIMITS.—Subsection (a) shall not be con- strued to prevent a group health plan or health
p.001561: insurance coverage from placing annual or lifetime per beneficiary limits on specific covered benefits that
p.001561: are not essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act, to
p.001561: the extent that such limits are otherwise permitted under Federal or State law.
p.001561: SEC. 2712. ø300gg–12¿ PROHIBITION ON RESCISSIONS.
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p.001571: condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent
p.001571: layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of
p.001571: immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section
p.001571: 1867(e)(1)(A) of the Social Security Act.
p.001571: (B) EMERGENCY SERVICES.—The term ‘‘emergency services’’ means, with respect to an emergency medical
p.001571: condition—
p.001571: (i) a medical screening examination (as required under section 1867 of the Social Security Act) that is
p.001571: within the capability of the emergency department of a hospital, including ancillary services routinely avail-
p.001571: able to the emergency department to evaluate such emergency medical condition, and
p.001571: (ii) within the capabilities of the staff and facili- ties available at the hospital, such further medical ex-
p.001571: amination and treatment as are required under sec- tion 1867 of such Act to stabilize the patient.
p.001571: (C) STABILIZE.—The term ‘‘to stabilize’’, with respect to an emergency medical condition (as defined in subpara-
p.001571: graph (A)), has the meaning give in section 1867(e)(3) of the Social Security Act (42 U.S.C. 1395dd(e)(3)).
p.001571: (c) ACCESS TO PEDIATRIC CARE.—
p.001571: (1) PEDIATRIC CARE.—In the case of a person who has a child who is a participant, beneficiary, or
p.001571: enrollee under a group health plan, or health insurance coverage offered by a health insurance issuer in
p.001571: the group or individual market, if the plan or issuer requires or provides for the designation of a
p.001571: participating primary care provider for the child, the plan or issuer shall permit such person to designate
p.001571: a physician (allopathic or osteopathic) who specializes in pediatrics as the child’s primary care
p.001571: provider if such provider participates in the network of the plan or issuer.
p.001571: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued to waive any exclusions of coverage under the
p.001571: terms and conditions of the plan or health insurance coverage with respect to coverage of pediatric care.
p.001571: (d) PATIENT ACCESS TO OBSTETRICAL AND GYNECOLOGICAL CARE.—
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p.001571: (1) GENERAL RIGHTS.—
p.001571: (A) DIRECT ACCESS.—A group health plan, or health insurance issuer offering group or individual health insur-
p.001571: ance coverage, described in paragraph (2) may not require authorization or referral by the plan, issuer, or any person
p.001571: (including a primary care provider described in paragraph (2)(B)) in the case of a female participant,
p.001571: beneficiary, or enrollee who seeks coverage for obstetrical or gynecological care provided by a participating
p.001571: health care professional who specializes in obstetrics or gynecology. Such profes-
p.001571: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001573: 1573
p.001573: PUBLIC HEALTH SERVICE ACT
p.001573: Sec. 2725
p.001573:
p.001573: sional shall agree to otherwise adhere to such plan’s or issuer’s policies and procedures, including
p.001573: procedures re- garding referrals and obtaining prior authorization and providing services pursuant to a
p.001573: treatment plan (if any) approved by the plan or issuer.
p.001573: (B) OBSTETRICAL AND GYNECOLOGICAL CARE.—A group health plan or health insurance issuer described in para-
p.001573: graph (2) shall treat the provision of obstetrical and gyne- cological care, and the ordering of related
p.001573: obstetrical and gynecological items and services, pursuant to the direct ac- cess described under subparagraph
p.001573: (A), by a participating health care professional who specializes in obstetrics or gynecology as the
p.001573: authorization of the primary care pro- vider.
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p.001577: Policy Non-Quantitative Treatment Limita- tions (NQTLs) that Require Additional Analysis to Deter- mine Mental
p.001577: Health Parity Compliance’’.
p.001577: (B) EXAMPLES ILLUSTRATING COMPLIANCE AND NON- COMPLIANCE.—
p.001577: (i) IN GENERAL.—The compliance program guid- ance document required under this paragraph shall provide
p.001577: illustrative, de-identified examples (that do not disclose any protected health information or indi-
p.001577: vidually identifiable information) of previous findings of compliance and noncompliance with this section,
p.001577: section 712 of the Employee Retirement Income Secu- rity Act of 1974, or section 9812 of the Internal Rev-
p.001577: enue Code of 1986, as applicable, based on investiga- tions of violations of such sections, including—
p.001577: (I) examples illustrating requirements for in- formation disclosures and nonquantitative treat- ment
p.001577: limitations; and
p.001577: (II) descriptions of the violations uncovered during the course of such investigations.
p.001577: (ii) NONQUANTITATIVE TREATMENT LIMITATIONS.— To the extent that any example described in clause (i) involves a
p.001577: finding of compliance or noncompliance with regard to any requirement for nonquantitative treatment
p.001577: limitations, the example shall provide suffi- cient detail to fully explain such finding, including a full
p.001577: description of the criteria involved for approving medical and surgical benefits and the criteria involved for
p.001577: approving mental health and substance use dis- order benefits.
p.001577: (iii) ACCESS TO ADDITIONAL INFORMATION REGARD- ING COMPLIANCE.—In developing and issuing the com- pliance
p.001577: program guidance document required under
p.001577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001579: PUBLIC HEALTH SERVICE ACT
p.001579: Sec. 2726
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p.001579: January 30, 2020
p.001579: this paragraph, the Secretaries specified in subpara- graph (A)—
p.001579: (I) shall enter into interagency agreements with the Inspector General of the Department of Health and
p.001579: Human Services, the Inspector Gen- eral of the Department of Labor, and the Inspec- tor General of the
p.001579: Department of the Treasury to share findings of compliance and noncompliance with this section, section 712 of
p.001579: the Employee Re- tirement Income Security Act of 1974, or section 9812 of the Internal Revenue Code of 1986, as
p.001579: ap- plicable; and
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p.001593: (vii) 19 reduces the maximum period permitted in an affiliation period under section 2701(g)(1)(B).
p.001593: (c) RULES OF CONSTRUCTION.—Nothing in this part (other than section 2704) shall be construed as requiring a
p.001593: group health plan or health insurance coverage to provide specific benefits under the terms of such plan or coverage.
p.001593: (d) DEFINITIONS.—For purposes of this section—
p.001593: (1) STATE LAW.—The term ‘‘State law’’ includes all laws, decisions, rules, regulations, or other State
p.001593: action having the effect of law, of any State. A law of the United States applica- ble only to the District of
p.001593: Columbia shall be treated as a State law rather than a law of the United States.
p.001593: (2) STATE.—The term ‘‘State’’ includes a State (including the Northern Mariana Islands), any political
p.001593: subdivisions of a
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p.001593: January 30, 2020
p.001593: 19 Clauses (i) through (vii) probably should be redesignated as subparagraphs (A) through (G). See section 102(a) of
p.001593: Public Law 104–191 (110 Stat. 1971).
p.001593: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001595: PUBLIC HEALTH SERVICE ACT
p.001595: Sec. 2741
p.001595:
p.001595: State or such Islands, or any agency or instrumentality of ei- ther. 20
p.001595: PART B—INDIVIDUAL MARKET RULES 21
p.001595: Subpart 1—Portability, Access, and Renewability Requirements
p.001595: SEC. 2741. ø300gg–41¿ GUARANTEED AVAILABILITY OF INDIVIDUAL HEALTH INSURANCE COVERAGE TO CERTAIN
p.001595: INDIVID- UALS WITH PRIOR GROUP COVERAGE.
p.001595: (a) GUARANTEED AVAILABILITY.—
p.001595: (1) IN GENERAL.—Subject to the succeeding subsections of this section and section 2744, each health
p.001595: insurance issuer that offers health insurance coverage (as defined in section 2791(b)(1)) in the individual
p.001595: market in a State may not, with respect to an eligible individual (as defined in subsection (b))
p.001595: desiring to enroll in individual health insurance coverage—
p.001595: (A) decline to offer such coverage to, or deny enroll- ment of, such individual; or
p.001595: (B) impose any preexisting condition exclusion (as de- fined in section 2701(b)(1)(A)) with respect to
p.001595: such cov- erage.
p.001595: (2) SUBSTITUTION BY STATE OF ACCEPTABLE ALTERNATIVE MECHANISM.—The requirement of paragraph (1) shall not
p.001595: apply to health insurance coverage offered in the individual market in a State in which the State is
p.001595: implementing an acceptable al- ternative mechanism under section 2744.
p.001595: (b) ELIGIBLE INDIVIDUAL DEFINED.—In this part, the term ‘‘eli- gible individual’’ means an individual—
p.001595: (1)(A) for whom, as of the date on which the individual seeks coverage under this section, the aggregate of
p.001595: the periods of creditable coverage (as defined in section 2701(c)) is 18 or more months and (B) whose
p.001595: most recent prior creditable cov- erage was under a group health plan, governmental plan, or church plan
p.001595: (or health insurance coverage offered in connection with any such plan);
...

p.001599: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001601: PUBLIC HEALTH SERVICE ACT
p.001601: Sec. 2744
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p.001601: January 30, 2020
p.001601: (i) a model act described in subsection (c)(1),
p.001601: (ii) a qualified high risk pool described in sub- section (c)(2), or
p.001601: (iii) a mechanism described in subsection (c)(3).
p.001601: (2) PERMISSIBLE FORMS OF MECHANISMS.—A private or public individual health insurance mechanism
p.001601: (such as a health insurance coverage pool or programs, mandatory group conversion policies, guaranteed
p.001601: issue of one or more plans of individual health insurance coverage, or open enrollment by one or more
p.001601: health insurance issuers), or combination of such mechanisms, that is designed to provide access to health bene-
p.001601: fits for individuals in the individual market in the State in ac- cordance with this section may constitute an
p.001601: acceptable alter- native mechanism.
p.001601: (b) APPLICATION OF ACCEPTABLE ALTERNATIVE MECHANISMS.—
p.001601: (1) PRESUMPTION.—
p.001601: (A) IN GENERAL.—Subject to the succeeding provisions of this subsection, a State is presumed to be implementing an
p.001601: acceptable alternative mechanism in accordance with this section as of July 1, 1997, if, by not later
p.001601: than April 1, 1997, the chief executive officer of a State—
p.001601: (i) notifies the Secretary that the State has en- acted or intends to enact (by not later than January
p.001601: 1, 1998, or July 1, 1998, in the case of a State de- scribed in subparagraph (B)(ii)) any necessary
p.001601: legisla- tion to provide for the implementation of a mechanism reasonably designed to be an acceptable
p.001601: alternative mechanism as of January 1, 1998, (or, in the case of a State described in subparagraph
p.001601: (B)(ii), July 1, 1998); and
p.001601: (ii) provides the Secretary with such information as the Secretary may require to review the mechanism and its
p.001601: implementation (or proposed implementation) under this subsection.
p.001601: (B) DELAY PERMITTED FOR CERTAIN STATES.—
p.001601: (i) EFFECT OF DELAY.—In the case of a State de- scribed in clause (ii) that provides notice under sub-
p.001601: paragraph (A)(i), for the presumption to continue on and after July 1, 1998, the chief executive officer
p.001601: of the State by April 1, 1998—
...

p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
p.001623: State, local, and tribal operations in the event of a public health emergency.
p.001623: (7) COUNTERMEASURES.—
p.001623: (A) Promoting strategic initiatives to advance counter- measures to diagnose, mitigate, prevent, or treat harm
p.001623: from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally
p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
p.001623: section 319F–3, and ‘‘security countermeasures’’ under section 319F–2.
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001623:
p.001623:
p.001623:
p.001623:
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p.001637: (B) The Administrator of the Administration for Com- munity Living.
p.001637: (C) The Director of the Biomedical Advanced Research and Development Authority.
p.001637: (D) The Director of the Centers for Disease Control and Prevention.
p.001637: (E) The Commissioner of Food and Drugs.
p.001637: (F) The Director of the National Institutes of Health.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: Sec. 2811D PUBLIC HEALTH SERVICE ACT 1638
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p.001637: January 30, 2020
p.001637:
p.001637: (G) The Administrator of the Federal Emergency Man- agement Agency.
p.001637: (H) The Chair of the National Council on Disability.
p.001637: (I) The Chair of the United States Access Board.
p.001637: (J) The Under Secretary for Health of the Department of Veterans Affairs.
p.001637: (K) At least 2 non-Federal health care professionals with expertise in disability accessibility before, during,
p.001637: and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.
p.001637: (L) At least 2 representatives from State, local, Tribal, or territorial agencies with expertise in disaster
p.001637: planning, preparedness, response, or recovery for individuals with disabilities.
p.001637: (M) At least 2 individuals with a disability with exper- tise in disaster planning, preparedness, response, or recov-
p.001637: ery for individuals with disabilities.
p.001637: (d) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (e) DISABILITY DEFINED.—For purposes of this section, the term ‘‘disability’’ has the meaning given such term in
p.001637: section 3 of the Americans with Disabilities Act of 1990.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) RECOMMENDATION.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommendation on whether the Advisory Committee should be extended.
p.001637: SEC. 2811D. ø42 U.S.C. 300hh-10e¿ ADVISORY COMMITTEE COORDINA- TION.
...

p.001643: Preparedness Act, the Secretary, in collaboration with State, local, and tribal officials, shall build on
p.001643: State, local, and tribal programs in existence on the date of enactment of such Act to establish and maintain a Medical
p.001643: Reserve Corps (referred to in this section as the ‘‘Corps’’) to provide for an adequate supply of volunteers in the
p.001643: case of a Federal, State, local, or tribal public health emergency. The Secretary may appoint a Director to head the
p.001643: Corps and oversee the activities of the Corps chapters that exist at the State, local, Tribal, and territorial levels.
p.001643: (b) STATE, LOCAL, AND TRIBAL COORDINATION.—The Corps shall be established using existing State,
p.001643: local, and tribal teams and shall not alter such teams.
p.001643: (c) COMPOSITION.—The Corps shall be composed of individuals who—
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p.001643: January 30, 2020
p.001643: (1)(A) are health professionals who have appropriate pro- fessional training and expertise as determined
p.001643: appropriate by the Director of the Corps; or
p.001643: (B) are non-health professionals who have an interest in serving in an auxiliary or support capacity to
p.001643: facilitate access to health care services in a public health emergency;
p.001643: (2) are certified in accordance with the certification pro- gram developed under subsection (d);
p.001643: (3) are geographically diverse in residence;
p.001643: (4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
p.001643: (5) indicate whether they are willing to be deployed out- side the area in which they reside in the
p.001643: event of a public health emergency.
p.001643: (d) CERTIFICATION; DRILLS.—
p.001643: (1) CERTIFICATION.—The Director, in collaboration with State, local, and tribal officials, shall establish a
p.001643: process for the periodic certification of individuals who volunteer for the Corps, as determined by the
p.001643: Secretary, which shall include the completion by each individual of the core training programs de- veloped under
p.001643: section 319F, as required by the Director. Such certification shall not supercede State
p.001643: licensing or credentialing requirements.
p.001643: (2) DRILLS.—In conjunction with the core training pro- grams referred to in paragraph (1), and in order
p.001643: to facilitate the integration of trained volunteers into the health care sys- tem at the local level, Corps
p.001643: members shall engage in periodic training exercises to be carried out at the local level. Such training
p.001643: exercises shall, as appropriate and applicable, incor- porate the needs of at-risk individuals in the event of a
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p.001647: to be appropriated
p.001647: $20,000,000 for each of fiscal years 2021 through 2025.
p.001647: TITLE XXIX—LIFESPAN RESPITE CARE
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p.001647: January 30, 2020
p.001647: SEC. 2901. ø300ii¿ DEFINITIONS.
p.001647: In this title:
p.001647: (1) ADULT WITH A SPECIAL NEED.—The term ‘‘adult with a special need’’ means a person 18 years of age or older
p.001647: who re- quires care or supervision to—
p.001647: (A) meet the person’s basic needs;
p.001647: (B) prevent physical self-injury or injury to others; or
p.001647: (C) avoid placement in an institutional facility.
p.001647: (2) AGING AND DISABILITY RESOURCE CENTER.—The term ‘‘aging and disability resource center’’ means an
p.001647: entity admin- istering a program established by the State, as part of the State’s system of long-term
p.001647: care, to provide a coordinated sys- tem for providing—
p.001647: (A) comprehensive information on available public and private long-term care programs, options, and resources;
p.001647: (B) personal counseling to assist individuals in assess- ing their existing or anticipated long-term care needs, and
p.001647: developing and implementing a plan for long-term care de- signed to meet their specific needs and circumstances; and
p.001647: (C) consumer access to the range of publicly supported long-term care programs for which consumers may be eli-
p.001647: gible, by serving as a convenient point of entry for such programs.
p.001647: (3) CHILD WITH A SPECIAL NEED.—The term ‘‘child with a special need’’ means an individual less than 18
p.001647: years of age who requires care or supervision beyond that required of chil- dren generally to—
p.001647: (A) meet the child’s basic needs; or
p.001647: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001647:
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p.001649: PUBLIC HEALTH SERVICE ACT
p.001649: Sec. 2902
p.001649:
p.001649: (B) prevent physical injury, self-injury, or injury to others.
p.001649: (4) ELIGIBLE STATE AGENCY.—The term ‘‘eligible State agency’’ means a State agency that—
p.001649: (A) administers the State’s program under the Older Americans Act of 1965, administers the State’s
p.001649: program under title XIX of the Social Security Act, or is designated by the Governor of such State to administer
p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
p.001649:
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p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
p.001649: thereby reducing family caregiver strain.
p.001649: (b) AUTHORIZATION.—Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for
p.001649: the pur- poses described in subsection (a) to eligible State agencies for which an application is submitted
p.001649: pursuant to subsection (d).
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001649: (c) FEDERAL LIFESPAN APPROACH.—In carrying out this section, the Secretary shall work in cooperation with
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p.001651: section shall use all or part of the funds—
p.001651: (i) to develop or enhance lifespan respite care at the State and local levels;
p.001651: (ii) to provide respite care services for family care- givers caring for children or adults;
p.001651: (iii) to train and recruit respite care workers and volunteers;
p.001651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001651: (iv) to provide information to caregivers about available respite and support services; and
p.001651: (v) to assist caregivers in gaining access to such services.
p.001651: (B) OPTIONAL USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section may use part of the funds for—
p.001651: (i) training programs for family caregivers to as- sist such family caregivers in making informed deci-
p.001651: sions about respite care services;
p.001651: (ii) other services essential to the provision of res- pite care as the Secretary may specify; or
p.001651: (iii) training and education for new caregivers.
p.001651: (2) SUBCONTRACTS.—Each eligible State agency awarded a grant or cooperative agreement under this section may
p.001651: carry out the activities described in paragraph (1) directly or by grant to, or contract with, public or
p.001651: private entities.
p.001651: (3) MATCHING FUNDS.—
p.001651: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out under paragraph (1), a
p.001651: condition for the receipt of a grant or cooperative agreement under this section is that the eligible
p.001651: State agency agrees to make available (directly or through donations from public or private entities)
p.001651: non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs.
p.001651: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions required by subparagraph (A) may be
p.001651: in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the
p.001651: Federal Government, or services assisted or subsidized to any sig- nificant extent by the Federal Government,
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p.001653: Sec. 3000 PUBLIC HEALTH SERVICE ACT 1654
p.001653:
p.001653: 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security
p.001653: Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in
p.001653: the Indian Self-Determina- tion and Education Assistance Act), tribal organization, or urban Indian
p.001653: organization (as defined in section 4 of the In- dian Health Care Improvement Act), a rural health
p.001653: clinic, a covered entity under section 340B, an ambulatory surgical cen- ter described in section 1833(i) of the
p.001653: Social Security Act, a therapist (as defined in section 1848(k)(3)(B)(iii) of the Social Security Act),
p.001653: and any other category of health care facility, entity, practitioner, or clinician determined appropriate by the
p.001653: Secretary.
p.001653: (4) HEALTH INFORMATION.—The term ‘‘health information’’ has the meaning given such term in section 1171(4) of
p.001653: the So- cial Security Act.
p.001653: (5) HEALTH INFORMATION TECHNOLOGY.—The term ‘‘health information technology’’ means hardware, software,
p.001653: integrated technologies or related licenses, intellectual property, up- grades, or packaged solutions
p.001653: sold as services that are de- signed for or support the use by health care entities or patients for the electronic
p.001653: creation, maintenance, access, or exchange of health information
p.001653: (6) HEALTH PLAN.—The term ‘‘health plan’’ has the mean- ing given such term in section 1171(5) of the
p.001653: Social Security Act.
p.001653: (7) HIT ADVISORY COMMITTEE.—The term ‘‘HIT Advisory Committee’’ means such Committee established under
p.001653: section 3002(a).
p.001653: (8) 1 INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION.— The term ‘‘individually identifiable health information’’
p.001653: has the meaning given such term in section 1171(6) of the Social Secu- rity Act.
p.001653: (9) 1 INTEROPERABILITY.—The term ‘‘interoperability’’, with respect to health information technology, means
p.001653: such health information technology that—
p.001653: (A) enables the secure exchange of electronic health information with, and use of electronic health information
p.001653: from, other health information technology without special effort on the part of the user;
p.001653: (B) allows for complete access, exchange, and use of all electronically accessible health information for
p.001653: authorized use under applicable State or Federal law; and
p.001653: (C) does not constitute information blocking as defined in section 3022(a).
p.001653: (10) 1 LABORATORY.—The term ‘‘laboratory’’ has the mean- ing given such term in section 353(a).
p.001653: (11) 1 NATIONAL COORDINATOR.—The term ‘‘National Coor- dinator’’ means the head of the Office of the
p.001653: National Coordi-
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p.001653: January 30, 2020
p.001653: 1 Subsections (a) and (e)(2)(B) of section 4003 of Public Law 114–255 provide for amendments to this section. Certain
p.001653: amendments as it relates to redesignating paragraph ranges were in con- flict with each other. The above list of
p.001653: paragraphs reflects them in the order of sequence in ac- cordance with the probable intent of Congress.
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001655: PUBLIC HEALTH SERVICE ACT
p.001655: Sec. 3001
p.001655:
p.001655: nator for Health Information Technology established under sec- tion 3001(a).
p.001655: (12) 1 PHARMACIST.—The term ‘‘pharmacist’’ has the mean- ing given such term in section 804(2) of the Federal
p.001655: Food, Drug, and Cosmetic Act.
p.001655: (13) 1 QUALIFIED ELECTRONIC HEALTH RECORD.—The term ‘‘qualified electronic health record’’ means an
p.001655: electronic record of health-related information on an individual that—
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p.001657: (iii) HEALTH INFORMATION TECHNOLOGY FOR PEDI- ATRICS.—Not later than 18 months after the date of enactment
p.001657: of the 21st Century Cures Act, the Sec- retary, in consultation with relevant stakeholders, shall
p.001657: make recommendations for the voluntary certifi- cation of health information technology for use by pe- diatric
p.001657: health providers to support the health care of children. Not later than 2 years after the date of en-
p.001657: actment of the 21st Century Cures Act, the Secretary shall adopt certification criteria under section 3004 to
p.001657: support the voluntary certification of health informa- tion technology for use by pediatric health providers to
p.001657: support the health care of children.
p.001657: (D) CONDITIONS OF CERTIFICATION.—Not later than 1 year after the date of enactment of the 21st Century Cures Act,
p.001657: the Secretary, through notice and comment rule- making, shall require, as a condition of
p.001657: certification and maintenance of certification for programs maintained or recognized under this paragraph,
p.001657: consistent with other conditions and requirements under this title, that the health information
p.001657: technology developer or entity—
p.001657: (i) does not take any action that constitutes infor- mation blocking as defined in section 3022(a);
p.001657: (ii) provides assurances satisfactory to the Sec- retary that such developer or entity, unless for
p.001657: legiti- mate purposes specified by the Secretary, will not take any action described in clause (i) or any other
p.001657: action that may inhibit the appropriate exchange, access, and use of electronic health information;
p.001657: (iii) does not prohibit or restrict communication regarding—
p.001657: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001659: PUBLIC HEALTH SERVICE ACT
p.001659: Sec. 3001
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p.001659: (I) the usability of the health information technology;
p.001659: (II) the interoperability of the health informa- tion technology;
p.001659: (III) the security of the health information technology;
p.001659: (IV) relevant information regarding users’ ex- periences when using the health information tech- nology;
p.001659: (V) the business practices of developers of health information technology related to exchang- ing
p.001659: electronic health information; and
p.001659: (VI) the manner in which a user of the health information technology has used such technology;
p.001659: (iv) has published application programming inter- faces and allows health information from such tech-
p.001659: nology to be accessed, exchanged, and used without special effort through the use of application program-
p.001659: ming interfaces or successor technology or standards, as provided for under applicable law, including pro-
p.001659: viding access to all data elements of a patient’s elec- tronic health record to the extent permissible
p.001659: under applicable privacy laws;
p.001659: (v) has successfully tested the real world use of the technology for interoperability (as defined in
p.001659: sec- tion 3000) in the type of setting in which such tech- nology would be marketed;
p.001659: (vi) provides to the Secretary an attestation that the developer or entity—
p.001659: (I) has not engaged in any of the conduct de- scribed in clause (i);
p.001659: (II) has provided assurances satisfactory to the Secretary in accordance with clause (ii);
p.001659: (III) does not prohibit or restrict communica- tion as described in clause (iii);
p.001659: (IV) has published information in accordance with clause (iv);
p.001659: (V) ensures that its technology allows for health information to be exchanged, accessed, and used, in the
p.001659: manner described in clause (iv); and
p.001659: (VI) has undertaken real world testing as de- scribed in clause (v); and
p.001659: (vii) submits reporting criteria in accordance with section 3009A(b).
p.001659: (E) COMPLIANCE WITH CONDITIONS OF CERTIFI- CATION.—The Secretary may encourage compliance
p.001659: with the conditions of certification described in subparagraph
p.001659: (D) and take action to discourage noncompliance, as appro- priate.
p.001659: (6) REPORTS AND PUBLICATIONS.—
p.001659: (A) REPORT ON ADDITIONAL FUNDING OR AUTHORITY NEEDED.—Not later than 12 months after the date of
p.001659: the enactment of this title, the National Coordinator shall sub- mit to the appropriate committees of
p.001659: jurisdiction of the
p.001659: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001659:
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p.001663: personnel from other Federal agencies without regard to whether the agency described under paragraph (1) is
p.001663: reimbursed.
p.001663: (e) CHIEF PRIVACY OFFICER OF THE OFFICE OF THE NATIONAL COORDINATOR.—Not later than 12 months after the date
p.001663: of the en- actment of this title, the Secretary shall appoint a Chief Privacy Officer of the Office of
p.001663: the National Coordinator, whose duty it shall be to advise the National Coordinator on privacy, security,
p.001663: and data stewardship of electronic health information and to co- ordinate with other Federal agencies
p.001663: (and similar privacy officers in such agencies), with State and regional efforts, and with foreign countries with
p.001663: regard to the privacy, security, and data steward- ship of electronic individually identifiable health
p.001663: information.
p.001663: SEC. 3002. ø300jj–12¿ HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.
p.001663: (a) ESTABLISHMENT.—There is established a Health Informa- tion Technology Advisory Committee (referred to in this
p.001663: section as the ‘‘HIT Advisory Committee’’) to recommend to the National Co- ordinator, consistent with the
p.001663: implementation of the strategic plan described in section 3001(c)(3), policies, and, for purposes of adop-
p.001663: tion under section 3004, standards, implementation specifications, and certification criteria, relating to the
p.001663: implementation of a health information technology infrastructure, nationally and locally, that advances the
p.001663: electronic access, exchange, and use of health infor- mation. Such Committee shall serve to unify the
p.001663: roles of, and re- place, the HIT Policy Committee and the HIT Standards Com-
p.001663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001663: Sec. 3002 PUBLIC HEALTH SERVICE ACT 1664
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p.001663: mittee, as in existence before the date of the enactment of the 21st Century Cures Act.
p.001663: (b) DUTIES.—
p.001663: (1) RECOMMENDATIONS ON POLICY FRAMEWORK TO ADVANCE AN INTEROPERABLE HEALTH INFORMATION TECHNOLOGY INFRA-
p.001663: STRUCTURE.—
p.001663: (A) IN GENERAL.—The HIT Advisory Committee shall recommend to the National Coordinator a policy frame-
p.001663: work for adoption by the Secretary consistent with the strategic plan under section 3001(c)(3) for
p.001663: advancing the target areas described in this subsection. Such policy framework shall seek to prioritize
p.001663: achieving advancements in the target areas specified in subparagraph (B) of para- graph (2) and may, to
p.001663: the extent consistent with this sec- tion, incorporate policy recommendations made by the HIT Policy Committee, as
p.001663: in existence before the date of the en- actment of the 21st Century Cures Act.
p.001663: (B) UPDATES.—The HIT Advisory Committee shall pro- pose updates to such recommendations to the policy frame- work and
p.001663: make new recommendations, as appropriate.
p.001663: (2) GENERAL DUTIES AND TARGET AREAS.—
p.001663: (A) IN GENERAL.—The HIT Advisory Committee shall recommend to the National Coordinator for purposes of
p.001663: adoption under section 3004, standards, implementation specifications, and certification criteria and an order of
p.001663: pri- ority for the development, harmonization, and recognition of such standards, specifications, and
p.001663: certification criteria. Such recommendations shall include recommended stand- ards, architectures, and software
p.001663: schemes for access to electronic individually identifiable health information across disparate
p.001663: systems including user vetting, authen- tication, privilege management, and access control.
p.001663: (B) PRIORITY TARGET AREAS.—For purposes of this sec- tion, the HIT Advisory Committee shall make rec-
p.001663: ommendations under subparagraph (A) with respect to at least each of the following target areas:
p.001663: (i) Achieving a health information technology in- frastructure, nationally and locally, that allows for the
p.001663: electronic access, exchange, and use of health informa- tion, including through technology that provides accu- rate
p.001663: patient information for the correct patient, includ- ing exchanging such information, and avoids the du-
p.001663: plication of patient records.
p.001663: (ii) The promotion and protection of privacy and security of health information in health information
p.001663: technology, including technologies that allow for an ac- counting of disclosures and protections against disclo-
p.001663: sures of individually identifiable health information made by a covered entity for purposes of treatment,
p.001663: payment, and health care operations (as such terms are defined for purposes of the regulation promulgated under
p.001663: section 264(c) of the Health Insurance Port- ability and Accountability Act of 1996), including for the
p.001663: segmentation and protection from disclosure of
p.001663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: 1665
p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
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p.001669: SEC. 3003. ø300jj–13¿ SETTING PRIORITIES FOR STANDARDS ADOP- TION.
p.001669: (a) IDENTIFYING PRIORITIES.—
p.001669: (1) IN GENERAL.—Not later than 6 months after the date on which the HIT Advisory Committee first meets,
p.001669: the Na- tional Coordinator shall periodically convene the HIT Advisory Committee to—
p.001669: (A) identify priority uses of health information tech- nology, focusing on priorities—
p.001669: (i) arising from the implementation of the incen- tive programs for the meaningful use of certified EHR
p.001669: technology, the Merit-based Incentive Payment Sys- tem, Alternative Payment Models, the Hospital Value- Based
p.001669: Purchasing Program, and any other value-based payment program determined appropriate by the Sec- retary;
p.001669: (ii) related to the quality of patient care;
p.001669: (iii) related to public health;
p.001669: (iv) related to clinical research;
p.001669: (v) related to the privacy and security of electronic health information;
p.001669: (vi) related to innovation in the field of health in- formation technology;
p.001669: (vii) related to patient safety;
p.001669: (viii) related to the usability of health information technology;
p.001669: (ix) related to individuals’ access to electronic health information; and
p.001669: (x) other priorities determined appropriate by the Secretary;
p.001669: (B) identify existing standards and implementation specifications that support the use and exchange of
p.001669: elec- tronic health information needed to meet the priorities identified in subparagraph (A); and
p.001669: (C) publish a report summarizing the findings of the analysis conducted under subparagraphs (A) and (B)
p.001669: and make appropriate recommendations.
p.001669: (2) PRIORITIZATION.—In identifying such standards and im- plementation specifications under paragraph (1)(B), the
p.001669: HIT Advisory Committee shall prioritize standards and implemen- tation specifications developed by
p.001669: consensus-based standards development organizations.
p.001669: (3) GUIDELINES FOR REVIEW OF EXISTING STANDARDS AND SPECIFICATIONS.—In consultation with the consensus-based en-
p.001669: tity described in section 1890 of the Social Security Act and other appropriate Federal agencies, the
p.001669: analysis of existing standards under paragraph (1)(B) shall include an evaluation of the need for a core set
p.001669: of common data elements and associ- ated value sets to enhance the ability of certified health infor- mation
p.001669: technology to capture, use, and exchange structured electronic health information.
p.001669: (b) REVIEW OF ADOPTED STANDARDS.—
p.001669: (1) IN GENERAL.—Beginning 5 years after the date of en- actment of the 21st Century Cures Act and
p.001669: every 3 years
p.001669: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001673: Sec. 3009 PUBLIC HEALTH SERVICE ACT 1674
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p.001673: (2) DEFINITION.—For purposes of this section, the term ‘‘HIPAA privacy and security law’’ means—
p.001673: (A) the provisions of part C of title XI of the Social Se- curity Act, section 264 of the Health Insurance Portability
p.001673: and Accountability Act of 1996, and subtitle D of title IV of the Health Information Technology for
p.001673: Economic and Clinical Health Act; and
p.001673: (B) regulations under such provisions.
p.001673: (b) FLEXIBILITY.—In administering the provisions of this title, the Secretary shall have flexibility in
p.001673: applying the definition of health care provider under section 3000(3), including the authority to omit certain
p.001673: entities listed in such definition when applying such definition under this title, where appropriate.
p.001673: (c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH IN-
p.001673: FORMATION THROUGH HEALTH INFORMATION EXCHANGES.—
p.001673: (1) IN GENERAL.—The Secretary shall use existing authori- ties to encourage partnerships between health
p.001673: information ex- change organizations and networks and health care providers, health plans, and other
p.001673: appropriate entities with the goal of of- fering patients access to their electronic health information in a
p.001673: single, longitudinal format that is easy to understand, se- cure, and may be updated automatically.
p.001673: (2) EDUCATION OF PROVIDERS.—The Secretary, in coordina- tion with the Office for Civil Rights of the
p.001673: Department of Health and Human Services, shall—
p.001673: (A) educate health care providers on ways of leveraging the capabilities of health information
p.001673: exchanges (or other relevant platforms) to provide patients with ac- cess to their electronic health
p.001673: information;
p.001673: (B) clarify misunderstandings by health care providers about using health information exchanges (or other rel-
p.001673: evant platforms) for patient access to electronic health in- formation; and
p.001673: (C) to the extent practicable, educate providers about health information exchanges (or other relevant
p.001673: platforms) that employ some or all of the capabilities described in paragraph (1).
p.001673: (3) REQUIREMENTS.—In carrying out paragraph (1), the Secretary, in coordination with the Office for Civil Rights,
p.001673: shall issue guidance to health information exchanges related to best practices to ensure that the electronic
p.001673: health information pro- vided to patients is—
p.001673: (A) private and secure;
p.001673: (B) accurate;
p.001673: (C) verifiable; and
p.001673: (D) where a patient’s authorization to exchange infor- mation is required by law, easily exchanged
p.001673: pursuant to such authorization.
p.001673: (4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to preempt State laws applicable to
p.001673: patient consent for the access of information through a health informa- tion exchange (or other relevant platform) that
p.001673: provide protec- tions to patients that are greater than the protections other- wise provided for under
p.001673: applicable Federal law.
p.001673: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001675: Sec. 3009
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p.001675: (d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.— The National Coordinator and the Office for Civil Rights
p.001675: of the De- partment of Health and Human Services shall jointly promote pa- tient access to health
p.001675: information in a manner that would ensure that such information is available in a form convenient for the pa-
p.001675: tient, in a reasonable manner, without burdening the health care provider involved.
p.001675: (e) ACCESSIBILITY OF PATIENT RECORDS.—
p.001675: (1) ACCESSIBILITY AND UPDATING OF INFORMATION.—
p.001675: (A) IN GENERAL.—The Secretary, in consultation with the National Coordinator, shall promote policies that
p.001675: en- sure that a patient’s electronic health information is acces- sible to that patient and the patient’s designees, in
p.001675: a man- ner that facilitates communication with the patient’s health care providers and other
p.001675: individuals, including re- searchers, consistent with such patient’s consent.
p.001675: (B) UPDATING EDUCATION ON ACCESSING AND EX- CHANGING PERSONAL HEALTH INFORMATION.—To promote
p.001675: awareness that an individual has a right of access to in- spect, obtain a copy of, and transmit to a
p.001675: third party a copy of such individual’s protected health information pur- suant to the Health Information
p.001675: Portability and Account- ability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations),
p.001675: the Director of the Office for Civil Rights, in consultation with the National Coordi- nator, shall assist
p.001675: individuals and health care providers in understanding a patient’s rights to access and protect per- sonal health
p.001675: information under the Health Insurance Port- ability and Accountability Act of 1996 (Public Law 104– 191),
p.001675: including providing best practices for requesting per- sonal health information in a computable format, including using
p.001675: patient portals or third-party applications and com- mon cases when a provider is permitted to exchange
p.001675: and provide access to health information.
p.001675: (2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the
p.001675: National Coordinator may require that—
p.001675: (A) the certification criteria support—
p.001675: (i) patient access to their electronic health infor- mation, including in a single longitudinal format
p.001675: that is easy to understand, secure, and may be updated automatically;
p.001675: (ii) the patient’s ability to electronically commu- nicate patient-reported information (such as family
p.001675: history and medical history); and
p.001675: (iii) patient access to their personal electronic health information for research at the option of the pa-
p.001675: tient; and
p.001675: (B) the HIT Advisory Committee develop and prioritize standards, implementation specifications,
p.001675: and certification criteria required to help support patient ac- cess to electronic health information, patient
p.001675: usability, and support for technologies that offer patients access to their electronic health information in
p.001675: a single, longitudinal for-
p.001675: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001675: Sec. 3009A PUBLIC HEALTH SERVICE ACT 1676
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p.001675: mat that is easy to understand, secure, and may be up- dated automatically.
p.001675: SEC. 3009A. ø300jj–19a¿ ELECTRONIC HEALTH RECORD REPORTING PROGRAM.
p.001675: (a) REPORTING CRITERIA.—
p.001675: (1) CONVENING OF STAKEHOLDERS.—Not later than 1 year after the date of enactment of the 21st Century Cures
p.001675: Act, the Secretary shall convene stakeholders, as described in para- graph (2), for the purpose of
p.001675: developing the reporting criteria in accordance with paragraph (3).
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p.001681: information tech- nology through—
p.001681: (A) assistance with the implementation, effective use, upgrading, and ongoing maintenance of health information
p.001681: technology, including electronic health records, to healthcare providers nationwide;
p.001681: (B) broad participation of individuals from industry, universities, and State governments;
p.001681: (C) active dissemination of best practices and research on the implementation, effective use, upgrading, and ongo- ing
p.001681: maintenance of health information technology, includ- ing electronic health records, to health care
p.001681: providers in order to improve the quality of healthcare and protect the privacy and security of health information;
p.001681: (D) participation, to the extent practicable, in health information exchanges;
p.001681: (E) utilization, when appropriate, of the expertise and capability that exists in Federal agencies other than
p.001681: the Department; and
p.001681: (F) integration of health information technology, in- cluding electronic health records, into the initial and
p.001681: ongo- ing training of health professionals and others in the healthcare industry that would be
p.001681: instrumental to improv- ing the quality of healthcare through the smooth and accu- rate electronic use and exchange of
p.001681: health information.
p.001681: (4) REGIONAL ASSISTANCE.—Each regional center shall aim to provide assistance and education to all providers in a
p.001681: region, but shall prioritize any direct assistance first to the following:
p.001681: (A) Public or not-for-profit hospitals or critical access hospitals.
p.001681: (B) Federally qualified health centers (as defined in section 1861(aa)(4) of the Social Security Act).
p.001681: (C) Entities that are located in rural and other areas that serve uninsured, underinsured, and medically
p.001681: under- served individuals (regardless of whether such area is urban or rural).
p.001681: (D) Individual or small group practices (or a consor- tium thereof) that are primarily focused on
p.001681: primary care.
p.001681: (5) FINANCIAL SUPPORT.—The Secretary may provide finan- cial support to any regional center created under this
p.001681: sub-
p.001681: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001683: PUBLIC HEALTH SERVICE ACT
p.001683: Sec. 3012
p.001683:
p.001683: section for a period not to exceed four years. The Secretary may not provide more than 50 percent of
p.001683: the capital and an- nual operating and maintenance funds required to create and maintain such a center,
p.001683: except in an instance of national eco- nomic conditions which would render this cost-share require- ment
p.001683: detrimental to the program and upon notification to Con- gress as to the justification to waive the cost-share
p.001683: require- ment.
p.001683: (6) NOTICE OF PROGRAM DESCRIPTION AND AVAILABILITY OF FUNDS.—The Secretary shall publish in the Federal
p.001683: Register, not later than 90 days after the date of the enactment of this title, a draft description of
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p.001683: (1) has submitted, and the Secretary has approved, a plan described in subsection (e) (regardless of whether
p.001683: such plan was prepared using amounts awarded under subsection (b); and
p.001683: (2) submits an application at such time, in such manner, and containing such information as the Secretary may
p.001683: specify.
p.001683: (d) USE OF FUNDS.—Amounts received under a grant under subsection (c) shall be used to conduct
p.001683: activities to facilitate and expand the electronic movement and use of health information among
p.001683: organizations according to nationally recognized standards through activities that include—
p.001683: (1) enhancing broad and varied participation in the au- thorized and secure nationwide electronic use and
p.001683: exchange of health information;
p.001683: (2) identifying State or local resources available towards a nationwide effort to promote health information
p.001683: technology;
p.001683: (3) complementing other Federal grants, programs, and ef- forts towards the promotion of health information
p.001683: technology;
p.001683: (4) providing technical assistance for the development and dissemination of solutions to barriers to the
p.001683: exchange of elec- tronic health information;
p.001683: (5) promoting effective strategies to adopt and utilize health information technology in medically
p.001683: underserved com- munities;
p.001683: (6) assisting patients in utilizing health information tech- nology;
p.001683: (7) encouraging clinicians to work with Health Information Technology Regional Extension Centers as described in
p.001683: section 3012, to the extent they are available and valuable;
p.001683: (8) supporting public health agencies’ authorized use of and access to electronic health information;
p.001683: (9) promoting the use of electronic health records for qual- ity improvement including through quality measures
p.001683: reporting; and
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p.001683: (10) such other activities as the Secretary may specify.
p.001683: (e) PLAN.—
p.001683: (1) IN GENERAL.—A plan described in this subsection is a plan that describes the activities to be
p.001683: carried out by a State or by the qualified State-designated entity within such State to
p.001683: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001687: reserve and security for leveraged loans, the proceeds of which are deposited in the Loan Fund established under
p.001687: subsection (c). Loans under this section may be used by a health care provider to—
p.001687: (1) facilitate the purchase of certified EHR technology;
p.001687: (2) enhance the utilization of certified EHR technology (which may include costs associated with upgrading
p.001687: health in- formation technology so that it meets criteria necessary to be a certified EHR technology);
p.001687: (3) train personnel in the use of such technology; or
p.001687: (4) improve the secure electronic exchange of health infor- mation.
p.001687: (f) TYPES OF ASSISTANCE.—Except as otherwise limited by ap- plicable State law, amounts deposited into a Loan
p.001687: Fund under this section may only be used for the following:
p.001687: (1) To award loans that comply with the following:
p.001687: (A) The interest rate for each loan shall not exceed the market interest rate.
p.001687: (B) The principal and interest payments on each loan shall commence not later than 1 year after the
p.001687: date the loan was awarded, and each loan shall be fully amortized not later than 10 years after the date of
p.001687: the loan.
p.001687: (C) The Loan Fund shall be credited with all payments of principal and interest on each loan awarded from the
p.001687: Loan Fund.
p.001687: (2) To guarantee, or purchase insurance for, a local obliga- tion (all of the proceeds of which finance a
p.001687: project eligible for assistance under this subsection) if the guarantee or purchase would improve credit market
p.001687: access or reduce the interest rate applicable to the obligation involved.
p.001687: (3) As a source of revenue or security for the payment of principal and interest on revenue or general
p.001687: obligation bonds issued by the eligible entity if the proceeds of the sale of the bonds will be deposited
p.001687: into the Loan Fund.
p.001687: (4) To earn interest on the amounts deposited into the Loan Fund.
p.001687: (5) To make reimbursements described in subsection (g)(4)(A).
p.001687: (g) ADMINISTRATION OF LOAN FUNDS.—
p.001687: (1) COMBINED FINANCIAL ADMINISTRATION.—An eligible en- tity may (as a convenience and to avoid unnecessary
p.001687: adminis- trative costs) combine, in accordance with applicable State law, the financial administration of a Loan Fund
p.001687: established under this subsection with the financial administration of any other revolving fund established
p.001687: by the entity if otherwise not pro- hibited by the law under which the Loan Fund was estab- lished.
p.001687: (2) COST OF ADMINISTERING FUND.—Each eligible entity may annually use not to exceed 4 percent of the funds
p.001687: provided to the entity under a grant under this section to pay the rea- sonable costs of the administration
p.001687: of the programs under this section, including the recovery of reasonable costs expended to establish a Loan Fund which
p.001687: are incurred after the date of the enactment of this title.
p.001687: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001689: Coordinator may not include any amounts provided to the entity by the Federal Government.
p.001689: (i) EFFECTIVE DATE.—The Secretary may not make an award under this section prior to January 1, 2010.
p.001689: SEC. 3015. ø300jj–35¿ DEMONSTRATION PROGRAM TO INTEGRATE IN- FORMATION TECHNOLOGY INTO CLINICAL EDUCATION.
p.001689: (a) IN GENERAL.—The Secretary may award grants under this section to carry out demonstration projects to develop
p.001689: academic curricula integrating certified EHR technology in the clinical edu- cation of health
p.001689: professionals. Such awards shall be made on a competitive basis and pursuant to peer review.
p.001689: (b) ELIGIBILITY.—To be eligible to receive a grant under sub- section (a), an entity shall—
p.001689: (1) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001689: Sec- retary may require;
p.001689: (2) submit to the Secretary a strategic plan for integrating certified EHR technology in the clinical education
p.001689: of health
p.001689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001689: Sec. 3015 PUBLIC HEALTH SERVICE ACT 1690
p.001689: professionals to reduce medical errors, increase access to pre- vention, reduce chronic diseases, and enhance
p.001689: health care qual- ity;
p.001689: (3) be—
p.001689: (A) a school of medicine, osteopathic medicine, den- tistry, or pharmacy, a graduate program in
p.001689: behavioral or mental health, or any other graduate health professions school;
p.001689: (B) a graduate school of nursing or physician assistant studies;
p.001689: (C) a consortium of two or more schools described in subparagraph (A) or (B); or
p.001689: (D) an institution with a graduate medical education program in medicine, osteopathic medicine,
p.001689: dentistry, pharmacy, nursing, or physician assistance studies;
p.001689: (4) provide for the collection of data regarding the effec- tiveness of the demonstration project to be
p.001689: funded under the grant in improving the safety of patients, the efficiency of health care delivery, and in
p.001689: increasing the likelihood that grad- uates of the grantee will adopt and incorporate certified EHR technology,
p.001689: in the delivery of health care services; and
p.001689: (5) provide matching funds in accordance with subsection
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p.001689: (d).
p.001689: (c) USE OF FUNDS.—
p.001689: (1) IN GENERAL.—With respect to a grant under subsection (a), an eligible entity shall—
p.001689: (A) use grant funds in collaboration with 2 or more disciplines; and
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p.001693: (i) a plan to adopt and implement appropriate en- rollment technology that includes—
p.001693: (I) proposed reduction in maintenance costs of technology systems;
p.001693: (II) elimination or updating of legacy systems;
p.001693: and
p.001693: (III) demonstrated collaboration with other
p.001693: entities that may receive a grant under this sec- tion that are located in the same State, political
p.001693: subdivision, or locality;
p.001693: (ii) an assurance that the entity will share such appropriate enrollment technology in accordance with
p.001693: paragraph (4); and
p.001693: (iii) such other information as the Secretary may require.
p.001693: (3) SHARING.—
p.001693: (A) IN GENERAL.—The Secretary shall ensure that ap- propriate enrollment HIT adopted under grants under this
p.001693: subsection is made available to other qualified State, qualified political subdivisions of a State,
p.001693: or other appro- priate qualified entities (as described in subparagraph (B)) at no cost.
p.001693: (B) QUALIFIED ENTITIES.—The Secretary shall deter- mine what entities are qualified to receive enrollment HIT
p.001693: under subparagraph (A), taking into consideration the rec- ommendations of the HIT Advisory Committee.
p.001693: SEC. 3022. ø300jj–52¿ INFORMATION BLOCKING.
p.001693: (a) DEFINITION.—
p.001693: (1) IN GENERAL.—In this section, the term ‘‘information blocking’’ means a practice that—
p.001693: (A) except as required by law or specified by the Sec- retary pursuant to rulemaking under paragraph
p.001693: (3), is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic
p.001693: health information; and
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p.001693: (B)(i) if conducted by a health information technology developer, exchange, or network, such developer,
p.001693: exchange, or network knows, or should know, that such practice is likely to interfere with, prevent, or
p.001693: materially discourage the access, exchange, or use of electronic health informa- tion; or
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p.001693: January 30, 2020
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p.001693: (ii) if conducted by a health care provider, such pro- vider knows that such practice is unreasonable and is
p.001693: like- ly to interfere with, prevent, or materially discourage ac- cess, exchange, or use of electronic health
p.001693: information.
p.001693: (2) PRACTICES DESCRIBED.—The information blocking prac- tices described in paragraph (1) may include—
p.001693: (A) practices that restrict authorized access, exchange, or use under applicable State or Federal law of such infor-
p.001693: mation for treatment and other permitted purposes under such applicable law, including transitions between
p.001693: certified health information technologies;
p.001693: (B) implementing health information technology in nonstandard ways that are likely to substantially increase
p.001693: the complexity or burden of accessing, exchanging, or using electronic health information; and
p.001693: (C) implementing health information technology in ways that are likely to—
p.001693: (i) restrict the access, exchange, or use of elec- tronic health information with respect to exporting
p.001693: complete information sets or in transitioning between health information technology systems; or
p.001693: (ii) lead to fraud, waste, or abuse, or impede inno- vations and advancements in health information ac- cess,
p.001693: exchange, and use, including care delivery en- abled by health information technology.
p.001693: (3) RULEMAKING.—The Secretary, through rulemaking, shall identify reasonable and necessary activities
p.001693: that do not constitute information blocking for purposes of paragraph (1).
p.001693: (4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.—The term ‘‘information blocking’’ does not include any
p.001693: practice or conduct occurring prior to the date that is 30 days after the date of enactment of the 21st
p.001693: Century Cures Act.
p.001693: (5) CONSULTATION.—The Secretary may consult with the Federal Trade Commission in promulgating regulations
p.001693: under this subsection, to the extent that such regulations define prac- tices that are necessary to promote
p.001693: competition and consumer welfare.
p.001693: (6) APPLICATION.—The term ‘‘information blocking’’, with respect to an individual or entity, shall not
p.001693: include an act or practice other than an act or practice committed by such indi- vidual or entity.
p.001693: (7) CLARIFICATION.—In carrying out this section, the Sec- retary shall ensure that health care providers
p.001693: are not penal- ized for the failure of developers of health information tech- nology or other entities
...

p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001697:
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p.001711: (7) The term ‘‘New York City disaster area’’ means the area within New York City that is—
p.001711: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001711: Sec. 3306 PUBLIC HEALTH SERVICE ACT 1712
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p.001711: January 30, 2020
p.001711:
p.001711: (A) the area of Manhattan that is south of Houston Street; and
p.001711: (B) any block in Brooklyn that is wholly or partially contained within a 1.5-mile radius of the former
p.001711: World Trade Center site.
p.001711: (8) The term ‘‘New York metropolitan area’’ means an area, specified by the WTC Program Administrator,
p.001711: within which WTC responders and eligible WTC screening-eligible survivors who reside in such area are reasonably
p.001711: able to access monitoring and treatment benefits and initial health evalua- tion benefits under this title
p.001711: through a Clinical Center of Ex- cellence described in subparagraphs (A), (B), or (C) of section
p.001711: 3305(b)(1).
p.001711: (9) The term ‘‘screening-eligible WTC survivor’’ has the meaning given such term in section 3321(a)(1).
p.001711: (10) Any reference to ‘‘September 11, 2001’’ shall be deemed a reference to the period on such
p.001711: date subsequent to the terrorist attacks at the World Trade Center, Shanksville, Pennsylvania, or the
p.001711: Pentagon, as applicable, on such date.
p.001711: (11) The term ‘‘September 11, 2001, terrorist attacks’’ means the terrorist attacks that occurred
p.001711: on September 11, 2001, in New York City, in Shanksville, Pennsylvania, and at the Pentagon, and includes the
p.001711: aftermath of such attacks.
p.001711: (12) The term ‘‘WTC Health Program Steering Committee’’ means such a Steering Committee established under
p.001711: section 3302(b).
p.001711: (13) The term ‘‘WTC Program’’ means the Word Trade Center Health Program established under section 3301(a).
p.001711: (14)(A) The term ‘‘WTC Program Administrator’’ means—
p.001711: (i) subject to subparagraph (B), with respect to para- graphs (3) and (4) of section 3311(a) (relating to
p.001711: enrollment of WTC responders), section 3312(c) and the corresponding provisions of section 3322 (relating to
p.001711: payment for initial health evaluation, monitoring, and treatment, paragraphs (1)(C), (2)(B), and (3) of
p.001711: section 3321(a) (relating to deter- mination or certification of screening-eligible or certified- eligible
p.001711: WTC responders), and part 3 of subtitle B (relating to payor provisions), an official in the Department
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p.001725:
p.001725: (2) MONITORING AND INITIAL HEALTH EVALUATION.—The WTC Program Administrator shall reimburse the costs of mon-
p.001725: itoring and the costs of an initial health evaluation provided under this title at a rate set by the
p.001725: Administrator by regula- tion.
p.001725: (3) DETERMINATION OF MEDICAL NECESSITY.—
p.001725: (A) REVIEW OF MEDICAL NECESSITY AND PROTOCOLS.— As part of the process for reimbursement or payment under
p.001725: this subsection, the WTC Program Administrator shall provide for the review of claims for reimbursement or
p.001725: payment for the provision of medical treatment to deter- mine if such treatment is medically necessary
p.001725: and in ac- cordance with medical treatment protocols established under subsection (d).
p.001725: (B) WITHHOLDING OF PAYMENT FOR MEDICALLY UNNEC- ESSARY TREATMENT.—The Administrator shall withhold such
p.001725: reimbursement or payment for treatment that the Administrator determines is not medically necessary or is
p.001725: not in accordance with such medical treatment protocols.
p.001725: (d) MEDICAL TREATMENT PROTOCOLS.—
p.001725: (1) DEVELOPMENT.—The Data Centers shall develop med- ical treatment protocols for the treatment of enrolled WTC
p.001725: re- sponders and certified-eligible WTC survivors for health condi- tions included in the applicable list of
p.001725: WTC-related health con- ditions.
p.001725: (2) APPROVAL.—The medical treatment protocols developed under paragraph (1) shall be subject to approval by
p.001725: the WTC Program Administrator.
p.001725: SEC. 3313. ø42 U.S.C. 300mm–23¿ NATIONAL ARRANGEMENT FOR BENE- FITS FOR ELIGIBLE INDIVIDUALS OUTSIDE NEW YORK.
p.001725: (a) IN GENERAL.—In order to ensure reasonable access to bene- fits under this subtitle for individuals who are
p.001725: enrolled WTC re- sponders, screening-eligible WTC survivors, or certified-eligible WTC survivors and who
p.001725: reside in any State, as defined in section 2(f), outside the New York metropolitan area, the WTC
p.001725: Program Administrator shall establish a nationwide network of health care providers to provide monitoring
p.001725: and treatment benefits and initial health evaluations near such individuals’ areas of residence in such States.
p.001725: Nothing in this subsection shall be construed as preventing such individuals from being provided such monitoring
p.001725: and treat- ment benefits or initial health evaluation through any Clinical Center of Excellence.
p.001725: (b) NETWORK REQUIREMENTS.—Any health care provider par- ticipating in the network under subsection (a) shall—
p.001725: (1) meet criteria for credentialing established by the Data Centers;
p.001725: (2) follow the monitoring, initial health evaluation, and treatment protocols developed under section
p.001725: 3305(a)(2)(A)(ii);
p.001725: (3) collect and report data in accordance with section 3304;
p.001725: and
p.001725: (4) meet such fraud, quality assurance, and other require-
p.001725:
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p.001725:
p.001725:
p.001725: January 30, 2020
p.001725: ments as the WTC Program Administrator establishes, includ- ing sections 1128 through 1128E of the Social Security Act,
p.001725: as applied by section 3301(d).
p.001725: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Pre- vention with
p.000017: respect to preterm labor and delivery and infant mor- tality.
p.000017: (f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical
p.000017: information that is about an individual and that is gathered or used during the course of biomedical
p.000017: research if—
p.000017: (A) an individual is identified; or
p.000017: (B) there is at least a very small risk, as determined by current scientific practices or statistical
p.000017: methods, that some combination of the information, the request, and other avail- able data sources could be
p.000017: used to deduce the identity of an in- dividual.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 77 PUBLIC HEALTH SERVICE ACT Sec. 302
p.000017:
p.000017: (2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in
p.000017: writing and accompanied by a statement of the basis for the determination.
p.000017: (B) Each such determination and statement of basis shall be available to the public, upon request,
p.000017: through the Office of the Chief FOIA Officer of the Department of Health and Human Serv- ices.
p.000017: (3) Nothing in this subsection shall be construed to limit a re- search participant’s access to information about
p.000017: such participant collected during the participant’s participation in the research.
p.000017: (g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of
p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
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p.000001: officers who are assigned to duty in the De- partment of Defense.
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p.000001: January 30, 2020
p.000001: APPOINTMENT OF PERSONNEL
p.000001: SEC. 207. ø209¿ (a)(1) Except as provided in subsections (b) and (e) of this section, original appointments to
p.000001: the Regular Corps may be made only in the warrant officer (W–1), chief warrant offi- cer (W–2), chief warrant officer
p.000001: (W–3), chief warrant officer (W–4), junior assistant, assistant, and senior assistant grades and original appointments
p.000001: to a grade above junior assistant shall be made only after passage of an examination, given in accordance with
p.000001: regula- tions of the President, in one or more of the several branches of medicine, dentistry, hygiene,
p.000001: sanitary engineering, pharmacy, psy- chology, nursing, or related scientific specialties in the field of pub- lic
p.000001: health.
p.000001: (2) Original appointments to the Reserve Corps may be made to any grade up to and including the director grade
p.000001: but only after passage of an examination given in accordance with regulations of the President. Reserve commissions
p.000001: shall be for an indefinite pe- riod and may be terminated at any time, as the President may di- rect.
p.000001: (3) No individual who has attained the age of forty-four shall be appointed to the Regular Corps, or
p.000001: called to active duty in the Reserve Corps for a period in excess of one year, unless (A) he has had a number
p.000001: of years of active service (as defined in section 211(d)) equal to the number of years by which his
p.000001: age exceeds forty-four, or (B) the Surgeon General determines that he possesses exceptional qualifications, not
p.000001: readily available elsewhere in the Commissioned Corps of the Public Health Service, for the perform- ance of
p.000001: special duties with the Service, or (C) in the case of an offi-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 9 PUBLIC HEALTH SERVICE ACT Sec. 207
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p.000001: January 30, 2020
p.000001: cer of the Reserve Corps, the Commissioned Corps of the Service has been declared by the President to be a
p.000001: military service.
p.000001: (b)(1) Not more than 10 per centum of the original appoint- ments to the Regular Corps authorized to be made
p.000001: during any fis- cal year may be made to grades above that of senior assistant, but no such appointment (other than
p.000001: an appointment under section
p.000001: 204) may be made to a grade above that of director. For the pur- pose of this subsection the number
p.000001: of original appointments au- thorized to be made during a fiscal year shall be (1) the excess of the
p.000001: number of officers of the Regular Corps authorized by the ap- propriation Act or Acts for such year
p.000001: over the number of officers on active duty in the Regular Corps on the first day of such year, plus
p.000001: (2) the number of such officers of the Regular Corps who, dur- ing such fiscal year, have been or will be
p.000001: retired upon attainment of age sixty-four or have for any other reason ceased to be on active duty. In determining
p.000001: the number of appointments authorized by this subsection an appointment shall be deemed to be made in the fiscal
p.000001: year in which the nomination is transmitted by the President to the Senate.
p.000001: (2) In addition to the number of original appointments to the Regular Corps authorized by paragraph (1)
p.000001: to be made to grades above that of senior assistant, original appointments authorized to be made to the Regular
p.000001: Corps in any year may be made to grades above that of senior assistant, but not above that of director, in the case of
p.000001: any individual who—
p.000001: (A)(i) was on active duty in the Regular Corps on July 1, 1960, (ii) was on such active duty
p.000001: continuously for not less than one year immediately prior to such date, and (iii) applies for appointment to the
p.000001: Regular Corps prior to July 1, 1962; or
p.000001: (B) does not come within clause (A)(i) and (ii) but was on active duty in the Reserve Corps continuously for
p.000001: not less than one year immediately prior to his appointment to the Regular Corps and has not served on active
p.000001: duty continuously for a pe- riod, occurring after June 30, 1960, of more than three and one-half years prior
p.000001: to applying for such appointment.
p.000001: (3) No person shall be appointed pursuant to this subsection unless he meets standards established in
p.000001: accordance with regula- tions of the President.
p.000001: (c) Commissions evidencing the appointment by the President of officers of the Regular or Reserve Corps
...

p.000001: active duty in such grade in such category, if such number is greater than the number fixed under
p.000001: section
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 17 PUBLIC HEALTH SERVICE ACT Sec. 211
p.000001:
p.000001: 209(c)) is insufficient to meet such requirements of the Service, offi- cers of either the Regular Corps or the Reserve
p.000001: Corps may be rec- ommended for temporary promotion to such grade in such category. Any such promotion may be terminated
p.000001: at any time, as may be di- rected by the President.
p.000001: (m) Any officer of the Regular Corps, or any officer of the Re- serve Corps on active duty, who is
p.000001: promoted to a higher grade shall, unless he expressly declines such promotion, be deemed for all purposes
p.000001: to have accepted such promotion; and shall not be re- quired to renew his oath of office, or to execute a new affidavit
p.000001: as required by the Act of December 11, 1926, as amended (5 U.S.C. 21a). 6
p.000001: RETIREMENT OF COMMISSIONED OFFICERS
p.000001: SEC. 211. ø212¿ (a)(1) A commissioned officer of the Service shall, if he applies for retirement, be
p.000001: retired on or after the first day of the month following the month in which he attains the age of sixty-four
p.000001: years. This paragraph does not permit or require the involuntary retirement of any individual because of
p.000001: the age of the individual.
p.000001: (2) A commissioned officer of the Service may be retired by the Secretary, and shall be retired if he applies
p.000001: for retirement, on the first day of any month after completion of thirty years of active service.
p.000001: (3) Any commissioned officer of the Service who has had less than thirty years of active service may be
p.000001: retired by the Secretary, with or without application by the officer, on the first day of any month after
p.000001: completion of twenty or more years of active service of which not less than ten are years of active
p.000001: commissioned service in any of the uniformed services.
p.000001: (4) Except as provided in paragraph (6), a commissioned officer retired pursuant to paragraph (1), (2), or (3)
p.000001: who was (in the case of an officer in the Reserve Corps) on active duty with the Service on the day preceding
p.000001: such retirement shall be entitled to receive retired pay calculated by multiplying the retired pay base
p.000001: deter- mined under section 1406 of title 10, United States Code, by the retired pay multiplier determined
p.000001: under section 1409 of such title for the numbers of years of service credited to the officer under this paragraph
p.000001: and in which, in the case of a temporary promotion to such grade, he has performed active duty for
p.000001: not less than six months, (A) for each year of active service, or (B) if it results in higher retired
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p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
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p.000017: (ii) the lifetime total of such compensation for the individual may not exceed an amount equal to the amount
p.000017: authorized to be paid under section 266.
p.000017: (B) PERMANENT AND TOTAL DISABILITY.—The limita- tion under subparagraph (A)(ii) does not apply in the case of
p.000017: an eligible individual who is determined to have a cov- ered injury or injuries meeting the definition
p.000017: of disability in section 216(i) of the Social Security Act (42 U.S.C. 416(i)).
p.000017: (4) WAITING PERIOD.—
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 65 PUBLIC HEALTH SERVICE ACT Sec. 266
p.000017:
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B), an eligible individual shall not be provided compensa- tion
p.000017: under this section for the first 5 work days of loss of employment income.
p.000017: (B) EXCEPTION.—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi-
p.000017: vidual is 10 or more work days.
p.000017: (5) TERMINATION OF BENEFITS.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employment income once the eligible individual involves reaches the age of 65.
p.000017: (d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) shall be in addition to
p.000017: any amounts received by an eligible individual under section 264.
p.000017: SEC. 266. ø239e¿ PAYMENT FOR DEATH.
p.000017: (a) DEATH BENEFIT.—
p.000017: (1) IN GENERAL.—The Secretary shall pay, in the case of an eligible individual whose death is determined to have
p.000017: resulted from a covered injury or injuries, a death benefit in the amount determined under
p.000017: paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public
p.000017: Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control
p.000017: and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the
p.000017: case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the
p.000017: survivor in the place of the parent).
p.000017: (2) BENEFIT AMOUNT.—
p.000017: (A) IN GENERAL.—The amount of the death benefit under paragraph (1) in a fiscal year shall equal
p.000017: the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under
p.000017: subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
p.000017: seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but
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p.000017: of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.).
p.000017: (B) EXCEPTION IN THE CASE OF A LIMITATION ON AP- PROPRIATIONS FOR DISABILITY BENEFITS UNDER PSOB.—In
p.000017: the event that disability benefits available to an eligible individual under the Public Safety Officers’
p.000017: Benefits Pro- gram under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets
p.000017: Act of 1968 (42 U.S.C. 3796 et seq.) are reduced because of a limitation on appro- priations, and such reduction
p.000017: would affect the amount that would be payable under subparagraph (A) without regard to this subparagraph,
p.000017: benefits shall be available under paragraph (1) to the extent necessary to ensure that the survivor or
p.000017: survivors of such individual receives a total amount equal to the amount described in paragraph (2).
p.000017: (b) ELECTION IN CASE OF DEPENDENTS.—
p.000017: (1) IN GENERAL.—In the case of an eligible individual whose death is determined to have resulted from a
p.000017: covered in- jury or injuries, if the individual had one or more dependents under the age of 18, the legal
p.000017: guardian of the dependents may, in lieu of the death benefit under subsection (a), elect to re- ceive on
p.000017: behalf of the aggregate of such dependents payments in accordance with this subsection. An election under
p.000017: the pre- ceding sentence is effective in lieu of a request under sub- section (a) by an individual who
p.000017: is not the legal guardian of such dependents.
p.000017: (2) AMOUNT OF PAYMENTS.—Payments under paragraph (1) with respect to an eligible individual described in such
p.000017: para- graph shall be made as if such individual were an eligible indi- vidual to whom compensation would be paid
p.000017: under subsection
p.000017: (a) of section 265, with the rate augmented in accordance with subsection (b)(2) of such section and with such
p.000017: individual con- sidered to be an eligible individual described in subsection (c)(3)(B) of such section.
p.000017: (3) LIMITATIONS.—
p.000017: (A) AGE OF DEPENDENTS.—No payments may be made under paragraph (1) once the youngest of the dependents involved
p.000017: reaches the age of 18.
p.000017: (B) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (i) IN GENERAL.—Any payment under paragraph
p.000017: (1) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insurance carrier, or em- ployer), under any other law or contractual agreement, to pay
p.000017: compensation for loss of employment income or to provide disability benefits, retirement benefits, life insurance
p.000017: benefits on behalf of dependents under the age of 18, or death benefits.
p.000017: (ii) RELATION TO OTHER OBLIGATIONS.—Payments under paragraph (1) shall not be made to with respect to an eligible
p.000017: individual to the extent that the total of amounts paid with respect to the individual under such paragraph
p.000017: and under the other obligations re- ferred to in clause (i) is an amount that exceeds the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 67 PUBLIC HEALTH SERVICE ACT Sec. 271
p.000017:
p.000017: rate of payment that applies under paragraph (2). If under any such other obligation a lump-sum payment is
p.000017: made, such payment shall, for purposes of this sub- paragraph, be deemed to be received over multiple years
p.000017: rather than received in a single year. The Sec- retary may, in the discretion of the Secretary, deter-
p.000017: mine how to apportion such payment over multiple years.
p.000017: (c) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) or (b) shall be in addition to
p.000017: any amounts re- ceived by an eligible individual under section 264.
p.000017: SEC. 267. ø239f¿ ADMINISTRATION.
p.000017: (a) ADMINISTRATION BY AGREEMENT WITH OTHER AGENCY OR AGENCIES.—The Secretary may administer any or all of
p.000017: the provi- sions of this part through Memorandum of Agreement with the head of any appropriate Federal
p.000017: agency.
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p.000017: 87 PUBLIC HEALTH SERVICE ACT Sec. 308
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p.000017: January 30, 2020
p.000017: GENERAL PROVISIONS RESPECTING EFFECTIVENESS, EFFICIENCY, AND QUALITY OF HEALTH SERVICES
p.000017: SEC. 308. ø242m¿ (a)(1) Not later than March 15 of each year, the Secretary shall submit to the President and
p.000017: Congress the fol- lowing reports:
p.000017: (A) A report on health care costs and financing. Such re- port shall include a description and analysis
p.000017: of the statistics collected under section 306(b)(1)(G).
p.000017: (B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the
p.000017: statis- tics collected under section 306(b)(1)(E).
p.000017: (C) A report on the utilization of health resources. Such re- port shall include a description and analysis, by
p.000017: age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(F).
p.000017: (D) A report on the health of the Nation’s people. Such re- port shall include a description and analysis, by
p.000017: age, sex, in- come, and geographic area, of the statistics collected under sec- tion 306(b)(1)(A).
p.000017: (2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics.
p.000017: (3) The Office of Management and Budget may review any re- port required by paragraph (1) of this subsection before its
p.000017: submis- sion to Congress, but the Office may not revise any such report or delay its submission beyond the date
p.000017: prescribed for its submission, and may submit to Congress its comments respecting any such re- port.
p.000017: (b)(1) No grant or contract may be made under section 304, 306, or 307 unless an application therefor
p.000017: has been submitted to the Secretary in such form and manner, and containing such infor- mation, as the Secretary may
p.000017: by regulation prescribe and unless a peer review group referred to in paragraph (2) has recommended the
p.000017: application for approval.
p.000017: (2)(A) Each application submitted for a grant or contract under section 306 in an amount exceeding $50,000 of direct
p.000017: costs and for a health services research, evaluation, or demonstration project, or for a grant under section
p.000017: 306(m), shall be submitted to a peer re- view group for an evaluation of the technical and scientific
p.000017: merits of the proposals made in each such application. The Director of the National Center for Health Statistics
p.000017: shall establish such peer re- view groups as may be necessary to provide for such an evaluation of each such
p.000017: application.
p.000017: (B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report
p.000017: its finding and rec- ommendations respecting the application to the Secretary, acting through the Director
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p.000017: duty of the Sec- retary to call a conference of all State health authorities joining in the request. Each State
p.000017: represented at any conference shall be en- titled to a single vote. Whenever at any such conference matters re- lating
p.000017: to mental health are to be discussed, the mental health au- thorities of the respective States shall be invited to
p.000017: attend.
p.000017: (b) From time to time the Secretary shall issue information re- lated to public health, in the form of publications or
p.000017: otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United
p.000017: States and other countries and other perti- nent health information for the use of persons and institutions con- cerned
p.000017: with health services.
p.000017: SEC. 310A. ø242s¿ CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN’S HEALTH.
p.000017: (a) ESTABLISHMENT.—There is established within the Office of the Director of the Centers for Disease Control and
p.000017: Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the
p.000017: ‘‘Office’’). The Office shall be headed by a direc- tor who shall be appointed by the Director of such Centers.
p.000017: (b) PURPOSE.—The Director of the Office shall—
p.000017: (1) report to the Director of the Centers for Disease Con- trol and Prevention on the current level of the
p.000017: Centers’ activity regarding women’s health conditions across, where appro- priate, age, biological, and
p.000017: sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and
p.000017: professional education, services, and treatment;
p.000017: (2) establish short-range and long-range goals and objec- tives within the Centers for women’s health
p.000017: and, as relevant and appropriate, coordinate with other appropriate offices on activities within the
p.000017: Centers that relate to prevention, re- search, education and training, service delivery, and policy de- velopment,
p.000017: for issues of particular concern to women;
p.000017: (3) identify projects in women’s health that should be con- ducted or supported by the Centers;
p.000017: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.000017: profes- sionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to
p.000017: women; and
p.000017: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.000017: Health (established under section 229(b)(4)).
p.000017: (c) DEFINITION.—As used in this section, the term ‘‘women’s health conditions’’, with respect to women of all
p.000017: age, ethnic, and ra- cial groups, means diseases, disorders, and conditions—
p.000017: (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and
p.000017: (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there
p.000017: is rea- sonable evidence that indicates that such factors or types may be different for women.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017:
p.000017: Sec. 311 PUBLIC HEALTH SERVICE ACT 90
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000017: PART B—FEDERAL-STATE COOPERATION
p.000017: IN GENERAL
p.000017: SEC. 311. ø243¿ (a) The Secretary is authorized to accept from State and local authorities any assistance in the
p.000017: enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and
p.000017: willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and
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p.000107: Sec. 317B PUBLIC HEALTH SERVICE ACT 108
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p.000107: January 30, 2020
p.000107:
p.000107: (1) IN GENERAL.—Not later than May 1 of each year, the Secretary shall submit to the Congress a report
p.000107: on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection
p.000107: (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
p.000107: (2) CERTAIN REQUIREMENTS.—Each report under para- graph (1) shall include, in addition to any other
p.000107: information that the Secretary may require, the following information:
p.000107: (A) The number of infants and children screened.
p.000107: (B) Demographic information on the population of in- fants and children screened, including the age and
p.000107: racial or ethnic status of such population.
p.000107: (C) The number of screening sites.
p.000107: (D) A description of the severity of the extent of the blood lead levels of the infants and children
p.000107: screened, ex- pressed in categories of severity.
p.000107: (E) The sources of payment for the screenings.
p.000107: (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from
p.000107: laboratories and health care providers to State and local health departments.
p.000107: (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if
p.000107: any, provided in the report under paragraph (1) preceding the report involved.
p.000107: (k) INDIAN TRIBES.—For purposes of this section, the term ‘‘po- litical subdivision’’ includes Indian tribes.
p.000107: (l) FUNDING.—
p.000107: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000107: be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years
p.000107: 1994 through 2005.
p.000107: (2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts appropriated under paragraph (1) for any fiscal year,
p.000107: the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities
p.000107: described in subsection (a) in addition to the program of grants established in such sub- section.
p.000107: (m) GUIDELINES FOR STANDARDIZED REPORTING.—The Sec- retary, acting through the Director of the Centers for
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p.000131: laws; and
p.000131: (4) coordinate with the National Coordinator for Health In- formation Technology, as appropriate, to assist
p.000131: States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such
p.000131: recognized standards are available, in order to facilitate interoperability between such systems and health
p.000131: information technology systems, in- cluding certified health information technology.
p.000131: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000131: to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
p.000131: SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.000131: (a) GRANTS.—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for
p.000131: screening, assessment, and treatment services, including culturally and linguistically ap- propriate services,
p.000131: as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal
p.000131: depression.
p.000131: (b) APPLICATION.—To seek a grant under this section, a State shall submit an application to the
p.000131: Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a
p.000131: minimum, any such application shall include expla- nations of—
p.000131: (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for
p.000131: mater- nal depression in 1 or more communities; and
p.000131: (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for
p.000131: maternal depression.
p.000131: (c) PRIORITY.—In awarding grants under this section, the Sec- retary may give priority to States proposing to
p.000131: improve or enhance access to screening services for maternal depression in primary care settings.
p.000131: (d) USE OF FUNDS.—The activities eligible for funding through a grant under subsection (a)—
p.000131: (1) shall include—
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: Sec. 317M PUBLIC HEALTH SERVICE ACT 132
p.000131:
p.000131: (A) providing appropriate training to health care pro- viders; and
p.000131: (B) providing information to health care providers, in- cluding information on maternal depression screening,
p.000131: treatment, and followup support services, and linkages to community-based resources; and
p.000131: (2) may include—
p.000131: (A) enabling health care providers (including obstetri- cian-gynecologists, pediatricians, psychiatrists,
p.000131: mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric
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p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
p.000135:
p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
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p.000135: (D) local public and private elementary or secondary schools; or
p.000135: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000135: U.S.C. 1437a).
p.000135: (c) PERFORMANCE MEASURES.—The Secretary shall establish needs indicators and performance measures to evaluate the
p.000135: activi- ties carried out under grants awarded under this section. Such in- dicators shall be commensurate with
p.000135: national measures of mater- nal and child health programs and shall be developed in consulta- tion with the
p.000135: Director of the Centers for Disease Control and Pre- vention.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000135: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000137: PUBLIC HEALTH SERVICE ACT
p.000137: Sec. 317P
p.000137:
p.000137: HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 13)
p.000137: SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall—
p.000137: (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe-
p.000137: cial studies that would determine the prevalence in var- ious age groups and populations of specific types of
p.000137: human papillomavirus (referred to in this section as ‘‘HPV’’) in dif- ferent sites in various regions of
p.000137: the United States, through collection of special specimens for HPV using a va- riety of laboratory-based testing
p.000137: and diagnostic tools; and
p.000137: (B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
p.000137: (2) REPORT.—The Secretary shall make a progress report to the Congress with respect to paragraph (1) no
p.000137: later than 1 year after the effective date of this section.
p.000137: (b) PREVENTION ACTIVITIES; EDUCATION PROGRAM.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall conduct
p.000137: preven- tion research on HPV, including—
p.000137: (A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
p.000137: (B) formative research to assist with the development of educational messages and information for the public,
p.000137: for patients, and for their partners about HPV;
p.000137: (C) surveys of physician and public knowledge, atti- tudes, and practices about genital HPV infection; and
p.000137: (D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and
p.000137: dis- seminate educational materials for the public and health care providers regarding HPV and its impact
p.000137: and preven- tion.
p.000137: (2) REPORT; FINAL PROPOSAL.—The Secretary shall make a progress report to the Congress with respect to
...

p.000137: the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or
p.000137: by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV
p.000137: shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in
p.000137: preventing the STD the materials are designed to address. Such requirement only applies to materials mass
p.000137: produced for the public and health care providers, and not to routine communications.
p.000137: (d) JOHANNA’S LAW.—
p.000137: (1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
p.000137: (A) IN GENERAL.—The Secretary shall carry out a na- tional campaign to increase the awareness and knowledge of
p.000137: health care providers and women with respect to gynecologic cancers.
p.000137: (B) WRITTEN MATERIALS.—Activities under the na- tional campaign under subparagraph (A) shall include—
p.000137: (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers;
p.000137: and
p.000137: (ii) distributing the materials to members of the public upon request.
p.000137: (C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities under the national campaign under subparagraph
p.000137: (A) shall, in accordance with applicable law and regulations, include developing and placing, in
p.000137: telecommunications media, public service announcements intended to encour- age women to discuss with their
p.000137: physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in
p.000137: which the written materials re- ferred to in subparagraph (B) can be obtained upon re- quest, and shall
p.000137: call attention to early warning signs and risk factors based on the best available medical informa- tion.
p.000137: (2) REPORT AND STRATEGY.—
p.000137: (A) REPORT.—Not later than 6 months after the date of the enactment of this subsection, the Secretary
p.000137: shall submit to the Congress a report including the following:
p.000137: (i) A description of the past and present activities of the Department of Health and Human Services to increase
p.000137: awareness and knowledge of the public with respect to different types of cancer, including
p.000137: gynecologic cancers.
p.000137: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000139: PUBLIC HEALTH SERVICE ACT
p.000139: Sec. 317P
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p.000253: persons with Hansen’s dis- ease. Each such site shall provide for the outpatient care and treat- ment for Hansen’s
p.000253: disease and related complications to any person determined by the Secretary to be in need of such care and
p.000253: treat- ment.
p.000253: (c) The Secretary shall carry out subsections (a) and (b) acting through an agency of the Service. For purposes
p.000253: of the preceding sentence, the agency designated by the Secretary shall carry out both activities relating
p.000253: to the provision of health services and ac- tivities relating to the conduct of research.
p.000253: (d) The Secretary shall make payments to the Board of Health of the State of Hawaii for the care and treatment
p.000253: (including out- patient care) in its facilities of persons suffering from Hansen’s dis- ease at a rate determined
p.000253: by the Secretary. The rate shall be ap- proximately equal to the operating cost per patient of such
p.000253: facili- ties, except that the rate may not exceed the comparable costs per patient with Hansen’s disease for care
p.000253: and treatment provided by the Center referred to in subsection (a). Payments under this sub- section are subject
p.000253: to the availability of appropriations for such purpose.
p.000253:
p.000253: COORDINATED PROGRAM TO IMPROVE PEDIATRIC ORAL HEALTH
p.000253: SEC. 320A. 26 ø247d–8¿ (a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources
p.000253: and Services Administration, shall establish a program to fund innovative oral health activities that
p.000253: improve the oral health of children under 6 years of age who are eligible for services provided under a Federal
p.000253: health program, to increase the utilization of dental services by such children, and to decrease the incidence
p.000253: of early childhood and baby bottle tooth decay.
p.000253: (b) GRANTS.—The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of
p.000253: dentistry or ac- credited dental training institutions or programs, community den- tal programs, and programs
p.000253: operated by the Indian Health Service (including federally recognized Indian tribes that receive medical
p.000253: services from the Indian Health Service, urban Indian health pro- grams funded under title V of the
p.000253: Indian Health Care Improve- ment Act, and tribes that contract with the Indian Health Service pursuant to
p.000253: the Indian Self-Determination and Education Assist- ance Act) to enable such schools, institutions, and programs
p.000253: to de- velop programs of oral health promotion, to increase training of oral health services providers in
p.000253: accordance with State practice
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253:
p.000253: January 30, 2020
p.000253: 25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489.
p.000253: 26 The placement of this section in title III was carried out to reflect the probable intent of
p.000253: Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to ‘‘Part B of
p.000253: the Public Health Service Act’’, without specifying which title of this Act was the subject of the
p.000253: amendment.
...

p.000259: (I) water supply;
p.000259: (II) chemical and pesticide exposures;
p.000259: (III) air quality; or
p.000259: (IV) exposure to lead;
p.000259: (ii) sewage treatment;
p.000259: (iii) solid waste disposal;
p.000259: (iv) rodent and parasitic infestation;
p.000259: (v) field sanitation;
p.000259: (vi) housing; and
p.000259: (vii) other environmental factors related to health;
p.000259:
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p.000259: January 30, 2020
p.000259: and
p.000259: (D) in the case of health centers receiving grants under subsection (g), special
p.000259: occupation-related health services for migratory and seasonal agricultural workers, including—
p.000259: (i) screening for and control of infectious diseases, including parasitic diseases; and
p.000259: (ii) injury prevention programs, including preven- tion of exposure to unsafe levels of agricultural chemi- cals
p.000259: including pesticides.
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000259:
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p.000259: Sec. 330 PUBLIC HEALTH SERVICE ACT 260
p.000259:
p.000259: (3) MEDICALLY UNDERSERVED POPULATIONS.—
p.000259: (A) IN GENERAL.—The term ‘‘medically underserved population’’ means the population of an urban or rural
p.000259: area designated by the Secretary as an area with a short- age of personal health services or a population group
p.000259: des- ignated by the Secretary as having a shortage of such serv- ices.
p.000259: (B) CRITERIA.—In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the
p.000259: spe- cific shortages of personal health services of an area or population group. Such criteria shall—
p.000259: (i) take into account comments received by the Secretary from the chief executive officer of a State and
p.000259: local officials in a State; and
p.000259: (ii) include factors indicative of the health status of a population group or residents of an area, the abil-
p.000259: ity of the residents of an area or of a population group to pay for health services and their accessibility to
p.000259: them, and the availability of health professionals to residents of an area or to a population group.
p.000259: (C) LIMITATION.—The Secretary may not designate a medically underserved population in a State or terminate
p.000259: the designation of such a population unless, prior to such designation or termination, the Secretary provides
p.000259: reason- able notice and opportunity for comment and consults with—
p.000259: (i) the chief executive officer of such State;
p.000259: (ii) local officials in such State; and
p.000259: (iii) the organization, if any, which represents a majority of health centers in such State.
p.000259: (D) PERMISSIBLE DESIGNATION.—The Secretary may designate a medically underserved population that does
p.000259: not meet the criteria established under subparagraph (B) if the chief executive officer of the State in which
...

p.000263: subsection (b)(1) or additional health services de- scribed in subsection (b)(2).
p.000263: (ii) PRIORITY EXPANSION PROJECTS.—In carrying out clause (i), the Secretary may give special consider- ation to
p.000263: expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health,
p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
p.000263: providing serv- ices to any medically underserved population among which there is a substantial incidence
p.000263: of infant mortality or among which there is a significant increase in the incidence of infant mortality.
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000265: 265
p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
p.000265:
p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: January 30, 2020
p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
p.000265: (B) such services will be continuous for each such re- cipient;
p.000265: (C) the center will provide follow-up services for indi- viduals who are referred by the center for
p.000265: services de- scribed in paragraph (1);
p.000265: (D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health
p.000265: services (including prenatal care) with respect to the pur- pose described in this subsection; and
p.000265: (E) the center will coordinate the provision of services with other maternal and child health providers
p.000265: operating in the catchment area.
p.000265: (g) MIGRATORY AND SEASONAL AGRICULTURAL WORKERS.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of—
p.000265: (A) migratory agricultural workers, seasonal agricul- tural workers, and members of the families of such migra-
p.000265: tory and seasonal agricultural workers who are within a designated catchment area; and
p.000265: (B) individuals who have previously been migratory agricultural workers but who no longer meet the
p.000265: require- ments of subparagraph (A) of paragraph (3) because of age or disability and members of the families of
p.000265: such individ- uals who are within such catchment area.
p.000265: (2) ENVIRONMENTAL CONCERNS.—The Secretary may enter into grants or contracts under this subsection with
p.000265: public and private entities to—
p.000265: (A) assist the States in the implementation and en- forcement of acceptable environmental health
p.000265: standards, including enforcement of standards for sanitation in mi- gratory agricultural worker and
p.000265: seasonal agricultural worker labor camps, and applicable Federal and State pes- ticide control standards; and
p.000265: (B) conduct projects and studies to assist the several States and entities which have received grants or
p.000265: contracts under this section in the assessment of problems related to camp and field sanitation, exposure to unsafe
p.000265: levels of ag- ricultural chemicals including pesticides, and other envi- ronmental health hazards to which
p.000265: migratory agricultural workers and seasonal agricultural workers, and members of their families, are exposed.
p.000265: (3) DEFINITIONS.—For purposes of this subsection:
p.000265: (A) MIGRATORY AGRICULTURAL WORKER.—The term ‘‘migratory agricultural worker’’ means an individual
p.000265: whose principal employment is in agriculture, who has been so employed within the last 24 months, and
p.000265: who es-
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000303: Sec. 331 PUBLIC HEALTH SERVICE ACT 304
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p.000303: January 30, 2020
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p.000303: income competitive with the average monthly income from a practice of an individual who is a member of the
p.000303: profession of the Corps member, who has equivalent training, and who has been in practice for a period
p.000303: equivalent to the period during which the Corps member has been in practice.
p.000303: (B) During the period beginning upon the expiration of the 36 months referred to in subparagraph (A) and ending with
p.000303: the month in which the member’s monthly pay and allowances are equal to or exceed the monthly income he received for
p.000303: the last of such 36 months, the member may receive in addition to his monthly pay and allowances an amount which
p.000303: when added to such monthly pay and allowances equals the monthly income he received for such last month.
p.000303: (C) For each month in which a member is directly engaged in the delivery of health services in a health professional
p.000303: short- age area in accordance with an agreement with the Secretary entered into under section
p.000303: 741(f)(1)(C), under which the Sec- retary is obligated to make payments in accordance with sec- tion
p.000303: 741(f)(2), the amount of any monthly increase under sub- paragraph (A) or (B) with respect to such member shall
p.000303: be de- creased by an amount equal to one-twelfth of the amount which the Secretary is obligated to pay upon
p.000303: the completion of the year of practice in which such month occurs.
p.000303: For purposes of subparagraphs (A) and (B), the term ‘‘monthly pay’’ includes special pay received under chapter 5
p.000303: of title 37 of the United States Code.
p.000303: (2) In the case of a member of the Corps who is directly en- gaged in the delivery of health
p.000303: services in a health professional shortage area in accordance with a service obligation incurred under the
p.000303: Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may
p.000303: be made for such a member only upon satisfactory completion of such serv- ice obligation, and the first 36
p.000303: months of such member’s being so engaged in the delivery of health services shall, for purposes of
p.000303: paragraph (1)(A), be deemed to begin upon such satisfactory com- pletion.
p.000303: (3) A member of the Corps described in subparagraph (C) of subsection (a)(1) shall when assigned to an entity
p.000303: under section 333 be subject to the personnel system of such entity, except that such member shall receive during
p.000303: the period of assignment the income that the member would receive if the member was a member of the Corps
p.000303: described in subparagraph (B) of such subsection.
...

p.000309: Labor, and Pensions of the Senate a report that describes the regulation.
p.000309: (3) Each regulation described in paragraph (1) shall take effect 180 days after the committees described in
p.000309: paragraph (2) receive a report referred to in such paragraph describing the regulation.
p.000309: (k)(1) The Secretary, acting through the Administrator of the Health Resources and Services
p.000309: Administration, shall identify, based on the data collected under paragraph (3), maternity care health
p.000309: professional target areas that satisfy the criteria described in paragraph (2) for purposes of, in
p.000309: connection with receipt of as- sistance under this title, assigning to such identified areas mater- nity
p.000309: care health professionals who, without application of this sub- section, would otherwise be eligible for such
p.000309: assistance. The Sec- retary shall distribute maternity care health professionals within health professional
p.000309: shortage areas using the maternity care health professional target areas so identified.
p.000309: (2) For purposes of paragraph (1), the Secretary shall establish
p.000309: criteria for maternity care health professional target areas that identify geographic areas within health
p.000309: professional shortage areas that have a shortage of maternity care health professionals.
p.000309: (3) For purposes of this subsection, the Secretary shall collect and publish in the Federal Register data
p.000309: comparing the availability and need of maternity care health services in health professional shortage areas
p.000309: and in areas within such health professional short- age areas.
p.000309: (4) In carrying out paragraph (1), the Secretary shall seek input from relevant provider organizations,
p.000309: including medical soci- eties, organizations representing medical facilities, and other orga- nizations with expertise
p.000309: in maternity care.
p.000309: (5) For purposes of this subsection, the term ‘‘full scope mater- nity care health services’’ includes during labor
p.000309: care, birthing, pre- natal care, and postpartum care.
p.000309: (6) Nothing in this subsection shall be construed as—
p.000309: (A) requiring the identification of a maternity care health professional target area in an area not
p.000309: otherwise already des- ignated as a health professional shortage area; or
p.000309: (B) affecting the types of health professionals, without ap- plication of this subsection, otherwise eligible for
p.000309: assistance, including a loan repayment or scholarship, pursuant to the ap- plication of this section.
p.000309:
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p.000309: January 30, 2020
p.000309:
p.000309: ASSIGNMENT OF CORPS PERSONNEL
p.000309: SEC. 333. ø254f¿ (a)(1) The Secretary may assign members of the Corps to provide, under regulations
p.000309: promulgated by the Sec- retary, health services in or to a health professional shortage area during the assignment
p.000309: period only if—
p.000309: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000309: Sec. 333 PUBLIC HEALTH SERVICE ACT 310
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p.000311: grant was made to the entity under para- graph (2).
p.000311: (2)(A) If in approving an application of an entity for the assign- ment of a member of the Corps described in
p.000311: subparagraph (C) of section 331(a)(1) the Secretary determines that the entity does not have sufficient financial
p.000311: resources to provide the member of the Corps with an income of not less than the income to which the
p.000311: member would be entitled if the member was a member described in subparagraph (B) of section 331(a)(1), the
p.000311: Secretary may make a grant to the entity to assure that the member of the Corps as- signed to it will
p.000311: receive during the period of assignment to the enti- ty such an income.
p.000311: (B) The amount of any grant under subparagraph (A) shall be determined by the Secretary. Payments under such a grant
p.000311: may be made in advance or by way of reimbursement, and at such inter- vals and on such conditions, as
p.000311: the Secretary finds necessary. No grant may be made unless an application therefor is submitted to and
p.000311: approved by the Secretary. Such an application shall be in such form, submitted in such manner, and
p.000311: contain such informa- tion, as the Secretary shall by regulation prescribe.
p.000311: (c) The Secretary shall assign Corps members to entities in health professional shortage areas without
p.000311: regard to the ability of the individuals in such areas, population groups, medical facilities, or other public
p.000311: facilities to pay for such services.
p.000311: (d)(1) The Secretary may provide technical assistance to a pub- lic or private entity which is located in a health
p.000311: professional short- age area and which desires to make an application under this sec- tion for assignment of a
p.000311: Corps member to such area. Assistance provided under this paragraph may include assistance to an entity in (A)
p.000311: analyzing the potential use of health professions personnel in defined health services delivery areas by
p.000311: the residents of such areas, (B) determining the need for such personnel in such areas,
p.000311: (C) determining the extent to which such areas will have a finan- cial base to support the practice of
p.000311: such personnel and the extent to which additional financial resources are needed to adequately support
p.000311: the practice, (D) determining the types of inpatient and other health services that should be provided by such
p.000311: personnel in such areas, and (E) developing long-term plans for addressing health professional shortages and
p.000311: improving access to health care. The Secretary shall encourage entities that receive technical assist- ance under
p.000311: this paragraph to communicate with other commu- nities, State Offices of Rural Health, State Primary
p.000311: Care Associa- tions and Offices, and other entities concerned with site develop- ment and community needs
p.000311: assessment.
p.000311: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000315: payments due for health care services provided by the entity, including payments from any third party (including
p.000315: a Federal, State, or local gov- ernment agency and any other third party) that is responsible for part or all of
p.000315: the charge for such services.
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p.000315: January 30, 2020
p.000315: PROVISION OF HEALTH SERVICES BY CORPS MEMBERS
p.000315: SEC. 335. ø254h¿ (a) In providing health services in a health professional shortage area, Corps members
p.000315: shall utilize the tech- niques, facilities, and organizational forms most appropriate for the area, population
p.000315: group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1)
p.000315: to all individuals in, or served by, such health professional shortage area regardless of their ability
p.000315: to pay for the services, and (2) in a manner which is cooperative with other health care providers
p.000315: serving such health professional shortage area.
p.000315: (b)(1) Notwithstanding any other provision of law, the Sec- retary may (A) to the maximum extent feasible make
p.000315: such arrange- ments as he determines necessary to enable Corps members to uti- lize the health facilities in or serving
p.000315: the health professional short- age area in providing health services; (B) make such arrangements as he determines
p.000315: are necessary for the use of equipment and sup- plies of the Service and for the lease or acquisition of other
p.000315: equip- ment and supplies; and (C) secure the permanent or temporary services of physicians, dentists,
p.000315: nurses, administrators, and other health personnel. If there are no health facilities in or serving such area, the
p.000315: Secretary may arrange to have Corps members provide health services in the nearest health facilities of the
p.000315: Service or may lease or otherwise provide facilities in or serving such area for the provision of health services.
p.000315: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000317: PUBLIC HEALTH SERVICE ACT
p.000317: Sec. 336
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p.000317: January 30, 2020
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p.000339: to such individual and the interest on such amount which would be payable if at the time it was paid it was a
p.000339: loan bearing in- terest at the maximum legal prevailing rate, ‘‘t’’ shall be the number of months that
p.000339: such individual agreed to practice his profession under agreement, and ‘‘s’’ shall be the number of
p.000339: months that such individual practices his profession in accord- ance with such agreement; and
p.000339: (2) in the case of an individual who has received a loan under this section, the full amount of the
p.000339: principal and interest owed by such individual under this section.
p.000339: SEC. 338H. ø254q¿ AUTHORIZATION OF APPROPRIATIONS.
p.000339: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section 43, there is authorized to be
p.000339: appropriated, out of any funds in the Treasury not otherwise appropriated, the following:
p.000339: (1) For fiscal year 2010, $320,461,632.
p.000339: (2) For fiscal year 2011, $414,095,394.
p.000339: (3) For fiscal year 2012, $535,087,442.
p.000339: (4) For fiscal year 2013, $691,431,432.
p.000339: (5) For fiscal year 2014, $893,456,433.
p.000339: (6) For fiscal year 2015, $1,154,510,336.
p.000339: (7) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for the preceding fiscal
p.000339: year adjusted by the product of—
p.000339: (A) one plus the average percentage increase in the costs of health professions education during the prior
p.000339: fiscal year; and
p.000339: (B) one plus the average percentage change in the number of individuals residing in health professions short-
p.000339: age areas designated under section 333 during the prior fiscal year, relative to the number of
p.000339: individuals residing in such areas during the previous fiscal year.
p.000339: (b) SCHOLARSHIPS FOR NEW PARTICIPANTS.—Of the amounts appropriated under subsection (a) for a fiscal
p.000339: year, the Secretary shall obligate not less than 10 percent for the purpose of providing contracts for—
p.000339: (1) scholarships under this subpart to individuals who have not previously received such scholarships; or
p.000339: (2) scholarships or loan repayments under the Loan Re- payment Program under section 338B to individuals
p.000339: from dis- advantaged backgrounds.
p.000339:
p.000339:
p.000339:
p.000339:
p.000339: January 30, 2020
p.000339: 43 The reference to ‘‘this section’’ in section 338H(a) probably should be a reference to ‘‘this
p.000339: subpart’’.
p.000339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000339: Sec. 338I PUBLIC HEALTH SERVICE ACT 340
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p.000349: aides shall—
p.000349: (A) extend for at least forty hours, and consist of classroom instruction and at least twenty hours (in the aggregate)
p.000349: of su- pervised clinical instruction directed toward preparing stu- dents to deliver home health services;
p.000349: (B) be carried out under appropriate professional super- vision and be designed to train students to
p.000349: maintain or en- hance the personal care of an individual in his home in a man- ner which promotes the functional
p.000349: independence of the indi- vidual; and
p.000349: (C) include training in—
p.000349: (i) personal care services designed to assist an indi- vidual in the activities of daily living such as
p.000349: bathing, ex- ercising, personal grooming, and getting in and out of bed; and
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p.000349: January 30, 2020
p.000349: (ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in
p.000349: providing good nutrition (by the purchasing and prepara- tion of food).
p.000349: (3) In making grants and entering into contracts under this subsection, special consideration shall be given
p.000349: to entities which es- tablish or will establish programs to provide training for persons fifty years of age
p.000349: and older who wish to become paraprofessionals (including homemaker home health aides) to provide home
p.000349: health services.
p.000349: (4) Applications for grants and contracts under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and con- tracts under this subsection $2,000,000 for each of the
p.000349: fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and
p.000349: September 30, 1987.
p.000349: (c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee
p.000349: on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
p.000349: (1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such
p.000349: subsections were in ef- fect prior to October 1, 1981);
p.000349: (2) the need to continue grants and loans under sub- sections (a) and (b) (as such subsections are in
p.000349: effect on the day after the date of enactment of the Orphan Drug Act); and
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000351: 351
p.000351: PUBLIC HEALTH SERVICE ACT
p.000351: Sec. 340
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p.000375: associated with operating approved grad- uate medical residency training programs, as described in sub- section (a).
p.000375: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000375: Sec. 340E PUBLIC HEALTH SERVICE ACT 376
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p.000375: (2) QUALIFIED HOSPITALS.—
p.000375: (A) IN GENERAL.—To qualify to receive payments under paragraph (1), a hospital shall be a
p.000375: free-standing hospital—
p.000375: (i) with a Medicare payment agreement and that is excluded from the Medicare inpatient hospital pro-
p.000375: spective payment system pursuant to section 1886(d)(1)(B) of the Social Security Act and its accom-
p.000375: panying regulations;
p.000375: (ii) whose inpatients are predominantly individ- uals under 18 years of age;
p.000375: (iii) that has an approved medical residency train- ing program as defined in section 1886(h)(5)(A) of the
p.000375: Social Security Act; and
p.000375: (iv) that is not otherwise qualified to receive pay- ments under this section or section 1886(h) of the So-
p.000375: cial Security Act.
p.000375: (B) ESTABLISHMENT OF RESIDENCY CAP.—In the case of a freestanding children’s hospital that, on the date of
p.000375: en- actment of this subsection, meets the requirements of sub- paragraph (A) but for which the Secretary has
p.000375: not deter- mined an average number of full-time equivalent residents under section 1886(h)(4) of the Social
p.000375: Security Act, the Secretary may establish such number of full-time equiva- lent residents for the purposes
p.000375: of calculating payments under this subsection.
p.000375: (3) PAYMENTS.—Payments to hospitals made under this subsection shall be made in the same manner as payments are
p.000375: made to children’s hospitals, as described in subsections (b) through (e).
p.000375: (4) PAYMENT AMOUNTS.—The direct and indirect payment amounts under this subsection shall be determined
p.000375: using per resident amounts that are no greater than the per resident amounts used for determining direct
p.000375: and indirect payment amounts under subsection (a).
p.000375: (5) REPORTING.—A hospital receiving payments under this subsection shall be subject to the reporting requirements under
p.000375: subsection (b)(3).
p.000375: (6) REMAINING FUNDS.—
p.000375: (A) IN GENERAL.—If the payments to qualified hos- pitals under paragraph (1) for a fiscal year are less
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p.000383: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000383: Sec. 340H PUBLIC HEALTH SERVICE ACT 384
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p.000383: (D) The number of patients treated by residents de- scribed in paragraph (4).
p.000383: (E) The number of visits by patients treated by resi- dents described in paragraph (4).
p.000383: (F) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents entering primary care practice (meaning any of the areas of practice listed in the
p.000383: definition of a pri- mary care residency program in section 749A).
p.000383: (G) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents who entered practice at a health care fa- cility—
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p.000383: (i) primarily serving a health professional short- age area with a designation in effect under section 332 or a
p.000383: medically underserved community (as defined in section 799B); or
p.000383: (ii) located in a rural area (as defined in section 1886(d)(2)(D) of the Social Security Act).
p.000383: (H) Other information as deemed appropriate by the Secretary.
p.000383: (2) AUDIT AUTHORITY; LIMITATION ON PAYMENT.—
p.000383: (A) AUDIT AUTHORITY.—The Secretary may audit a qualified teaching health center to ensure the accuracy and
p.000383: completeness of the information submitted in a report under paragraph (1).
p.000383: (B) LIMITATION ON PAYMENT.—A teaching health cen- ter may only receive payment in a cost reporting period for
p.000383: a number of such resident positions that is greater than the base level of primary care resident positions, as
p.000383: deter- mined by the Secretary. For purposes of this subpara- graph, the ‘‘base level of primary care
p.000383: residents’’ for a teaching health center is the level of such residents as of a base period.
p.000383: (3) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
p.000383: (A) IN GENERAL.—The amount payable under this sec- tion to a qualified teaching health center for a fiscal
p.000383: year shall be reduced by at least 25 percent if the Secretary de- termines that—
p.000383: (i) the qualified teaching health center has failed to provide the Secretary, as an addendum to the quali- fied
p.000383: teaching health center’s application under this section for such fiscal year, the report required under
p.000383: paragraph (1) for the previous fiscal year; or
p.000383: (ii) such report fails to provide complete and accu- rate information required under any subparagraph of such
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p.000399: (m) PEDIATRIC STUDIES.—
p.000399: (1) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (h), (i), (j), (k),
p.000399: (l), (n), and (p) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the
p.000399: extension of a period under para- graphs (2) and (3) to the same extent and in the same manner as such provisions
p.000399: apply with respect to the extension of a pe- riod under subsection (b) or (c) of section 505A of the Federal
p.000399: Food, Drug, and Cosmetic Act.
p.000399: (2) MARKET EXCLUSIVITY FOR NEW BIOLOGICAL PRODUCTS.— If, prior to approval of an application that is
p.000399: submitted under
p.000399: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000401: PUBLIC HEALTH SERVICE ACT
p.000401: Sec. 351
p.000401:
p.000401: subsection (a), the Secretary determines that information relat- ing to the use of a new biological product in the
p.000401: pediatric popu- lation may produce health benefits in that population, the Sec- retary makes a written request for
p.000401: pediatric studies (which shall include a timeframe for completing such studies), the ap- plicant agrees to the
p.000401: request, such studies are completed using appropriate formulations for each age group for which the study is
p.000401: requested within any such timeframe, and the reports thereof are submitted and accepted in accordance with section
p.000401: 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act—
p.000401: (A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6
p.000401: months rather than 4 years and 12 years and 6 months rather than 12 years; and
p.000401: (B) if the biological product is designated under sec- tion 526 for a rare disease or condition, the period for
p.000401: such biological product referred to in section 527(a) is deemed to be 7 years and 6 months rather than 7 years.
p.000401: (3) MARKET EXCLUSIVITY FOR ALREADY-MARKETED BIOLOGI- CAL PRODUCTS.—If the Secretary determines that
p.000401: information relating to the use of a licensed biological product in the pedi- atric population may produce health
p.000401: benefits in that popu- lation and makes a written request to the holder of an ap- proved application
p.000401: under subsection (a) for pediatric studies (which shall include a timeframe for completing such studies), the
p.000401: holder agrees to the request, such studies are completed using appropriate formulations for each age
p.000401: group for which the study is requested within any such timeframe, and the re- ports thereof are submitted and
p.000401: accepted in accordance with section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act—
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p.000401: (A) the periods for such biological product referred to in subsection (k)(7) are deemed to be 4 years and 6
p.000401: months rather than 4 years and 12 years and 6 months rather than 12 years; and
p.000401: (B) if the biological product is designated under sec- tion 526 for a rare disease or condition, the period for
p.000401: such biological product referred to in section 527(a) is deemed to be 7 years and 6 months rather than 7 years.
p.000401: (4) EXCEPTION.—The Secretary shall not extend a period referred to in paragraph (2)(A), (2)(B), (3)(A),
p.000401: or (3)(B) if the determination under section 505A(d)(4) is made later than 9 months prior to the expiration
p.000401: of such period.
p.000401: (n) DATE OF APPROVAL IN THE CASE OF RECOMMENDED CON-
p.000401: TROLS UNDER THE CSA.—
p.000401: (1) IN GENERAL.—In the case of an application under sub- section (a) with respect to a biological
p.000401: product for which the Secretary provides notice to the sponsor that the Secretary in- tends to issue a
p.000401: scientific and medical evaluation and rec- ommend controls under the Controlled Substances Act, ap- proval
...

p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000449:
p.000449:
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
p.000449:
p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
p.000449: (1) receiving from interested persons critical comments re- lating to the manner in which the Organ Procurement
p.000449: and Transplantation Network is carrying out the duties of the Net- work under subsection (b); and
p.000449: (2) the consideration by the Secretary of such critical com- ments.
p.000449: SCIENTIFIC REGISTRY
p.000449: SEC. 373. ø274a¿ The Secretary shall, by grant or contract, de- velop and maintain a scientific registry of the
p.000449: recipients of organ transplants. The registry shall include such information respecting patients and transplant
...

p.000459: istry in the search for such a donor.
p.000459: ‘‘(3) The number of such patients for whom the Registry began a preliminary search but for whom the full search
p.000459: process was not completed, and the reasons underlying such cir- cumstances.
p.000459: ‘‘(4) The extent to which the plan required in section 2(b)(2) of this Act (relating to the
p.000459: relationship between the Registry and donor centers) has been implemented.
p.000459: ‘‘(5) The extent to which the Registry, donor centers, donor registries, collection centers, transplant
p.000459: centers, and other appropriate entities have been complying with the standards, criteria, and procedures under
p.000459: subsection (e) of such section 379 (as redesignated by section 2(c) of this Act).
p.000459: ‘‘(b) REPORT.—A report describing the findings of the study under subsection (a) shall be sub- mitted to the Congress
p.000459: not later than October 1, 2001. The report may not be submitted before January 1, 2001.’’.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000459:
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p.000461: 461
p.000461: PUBLIC HEALTH SERVICE ACT
p.000461: Sec. 379
p.000461:
p.000461: matched to a particular patient through the office estab- lished under subsection (h);
p.000461: (I) with respect to searches for unrelated donors of bone marrow that are conducted through the system under
p.000461: subparagraph (A), collect, analyze, and publish data in a standardized electronic format on the number and
p.000461: percent- age of patients at each of the various stages of the search process, including data regarding the
p.000461: furthest stage reached, the number and percentage of patients who are unable to complete the search process,
p.000461: and the reasons un- derlying such circumstances;
p.000461: (J) support studies and demonstration and outreach projects for the purpose of increasing the number of
p.000461: indi- viduals who are willing to be marrow donors to ensure a genetically diverse donor pool; and
p.000461: (K) facilitate research with the appropriate Federal agencies to improve the availability, efficiency, safety,
p.000461: and cost of transplants from unrelated donors and the effec- tiveness of Program operations.
p.000461: (2) CORD BLOOD FUNCTIONS.—
p.000461: (A) IN GENERAL.—With respect to cord blood, the Pro- gram shall—
p.000461: (i) 85 operate a system for identifying, matching, and facilitating the distribution of donated cord
p.000461: blood units that are suitably matched to candidate patients and meet all applicable Federal and State
p.000461: regulations (including in- formed consent and Food and Drug Administration regula- tions) from a qualified cord blood
p.000461: bank;
p.000461: (ii) 85 consistent with paragraph (3), allow transplant physicians, other appropriate health care
p.000461: professionals, and patients to search by means of electronic access all available cord blood units made
p.000461: available through the Pro- gram;
p.000461: (iii) 85 allow transplant physicians and other appro- priate health care professionals to reserve, as
p.000461: defined by the Secretary, a cord blood unit for transplantation;
...

p.000479: ‘‘and’’ appears after ‘‘1994,’’, not ‘‘1994’’.)
p.000479: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000479: Sec. 395 PUBLIC HEALTH SERVICE ACT 480
p.000479:
p.000479: PART K—HEALTH CARE SERVICES IN THE HOME AND PUBLIC HEALTH PROGRAMS FOR DEMENTIA 90
p.000479: Subpart I—Grants for Demonstration Projects
p.000479: SEC. 395. ø280c¿ ESTABLISHMENT OF PROGRAM.
p.000479: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000479: Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of
p.000479: assisting grantees in carrying out demonstration projects—
p.000479: (1) to identify low-income individuals who can avoid insti- tutionalization or prolonged hospitalization if 91 skilled
p.000479: nursing care services, homemaker or home health aide services, or per- sonal care services are provided in the
p.000479: homes of the individ- uals;
p.000479: (2) to pay the costs of the provision of such services in the homes of such individuals; and
p.000479: (3) to coordinate the provision by public and private enti- ties of such services, and other long-term
p.000479: care services, in the homes of such individuals.
p.000479: (b) REQUIREMENT WITH RESPECT TO AGE OF RECIPIENTS OF
p.000479: SERVICES.—The Secretary may not make a grant under subsection
p.000479: (a) to a State unless the State agrees to ensure that—
p.000479: (1) not less than 25 percent of the grant is expended to provide services under such subsection to
p.000479: individuals who are not less than 65 years of age; and
p.000479: (2) of the portion of the grant reserved by the State for purposes of complying with paragraph (1), not less
p.000479: than 10 per- cent is expended to provide such services to individuals who are not less than 85 years of age.
p.000479: (c) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a grant under
p.000479: sub- section (a) for any item or service to the extent that payment has been made, or can reasonably be
p.000479: expected to be made, with respect to such item or service—
p.000479: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000479: health benefits program; or
p.000479: (2) by an entity that provides health services on a prepaid basis.
p.000479: SEC. 396. ø280c–1¿ LIMITATION ON DURATION OF GRANT AND RE- QUIREMENT OF MATCHING FUNDS.
p.000479: (a) LIMITATION ON DURATION OF GRANT.—The period during which payments are made to a State from a
p.000479: grant under section 395(a) may not exceed 3 years. Such payments shall be subject to annual evaluation by
p.000479: the Secretary.
p.000479: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000479:
p.000479:
p.000479:
p.000479:
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p.000479:
p.000479: January 30, 2020
p.000479: 90 The style or formatting of the heading of Park K, as amended by section 2(1) of Public Law 115–406 and carried out
p.000479: above, reflects the original traditional style of such part heading.
p.000479: 91 Section 2(f) of Public Law 102–108 (105 Stat. 550) provides as follows: ‘‘(f) PUBLIC HEALTH SERVICE ACT TECHNICAL
p.000479: AMENDMENTS.—Section 395. [280c](a)(1) after the word ‘if’ insert the words ‘skilled medical services,’ ’’.
p.000479: The text of such section 2(f) does not provide sufficient amend- atory instructions to execute an amendment. The
p.000479: apparent intent of the Congress was to amend section 395(a)(1) of the Public Health Service Act (42 U.S.C. 280c(a)(1)).
p.000479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000479:
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p.000487: (2) not later than 1 year after the completion of such eval- uations, submit to the Congress a report describing
p.000487: the find- ings made as a result of the evaluations.
p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: 491
p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
p.000491: the entity will provide continuing training and sufficient support to the home visitors; and
p.000491: (3) such other information as the Secretary determines to be appropriate.
p.000491: (k) LIMITATION REGARDING ADMINISTRATIVE EXPENSES.—Not more than 10 percent of a grant under subsection
...

p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000491:
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p.000493: 493
p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
...

p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: Sec. 399A PUBLIC HEALTH SERVICE ACT 500
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p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
...

p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
p.000505:
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p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000505:
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
...

p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
p.000505:
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p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: 507
p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
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p.000521:
p.000521: Sec. 399H PUBLIC HEALTH SERVICE ACT 522
p.000521:
p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: January 30, 2020
p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
...

p.000523: Syn- drome and Fetal Alcohol Effect (referred to in this subsection as the ‘‘Task Force’’) to foster
p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
p.000523: hol Effect, including programs and research concerning education and public awareness for relevant service
p.000523: pro- viders, school-age children, women at-risk, and the general public, medical diagnosis, interventions for
p.000523: women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and
p.000523: beneficial services for indi- viduals with Fetal Alcohol Syndrome and Fetal Alcohol Ef- fect and their families;
p.000523: (B) coordinate its efforts with the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the
p.000523: De- partment of Health and Human Services; and
p.000523: (C) report on a biennial basis to the Secretary and rel- evant committees of Congress on the current and planned
p.000523: activities of the participating agencies.
p.000523: (4) TIME FOR APPOINTMENT.—The members of the Task Force shall be appointed by the Secretary not later
p.000523: than 6 months after the date of enactment of this part.
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: Sec. 399I PUBLIC HEALTH SERVICE ACT 524
p.000523:
p.000523: SEC. 399I. ø280f–1¿ ELIGIBILITY.
p.000523: To be eligible to receive a grant, or enter into a cooperative agreement or contract under this part, an
p.000523: entity shall—
...

p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
p.000529: screening, evaluation, and intervention programs and systems;
p.000529: (iii) to collect data and report on newborn, infant, and young child hearing screening, evaluation, diag- nosis,
p.000529: and intervention programs and systems for ap- plied research, program evaluation, and policy im-
p.000529: provement;
p.000529: (iv) to identify the causes and risk factors for con- genital hearing loss;
p.000529: (v) to study the effectiveness of newborn, infant, and young child hearing screening, audiologic and
p.000529: medical evaluations and intervention programs and systems by assessing the health, intellectual and so-
p.000529: cial developmental, cognitive, and hearing status of these children at school age; and
p.000529: (vi) to promote the integration and interoper- ability of data regarding early hearing loss across mul-
p.000529: tiple sources to increase the flow of information be- tween clinical care and public health settings,
p.000529: includ- ing the ability of States and territories to exchange and share data.
p.000529: (2) NATIONAL INSTITUTES OF HEALTH.—The Director of the National Institutes of Health, acting through the
p.000529: Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
p.000529: this section, continue a pro- gram of research and development on the efficacy of new screening techniques
p.000529: and technology, including clinical studies of screening methods, studies on efficacy of intervention, and
p.000529: related research.
p.000529: (c) COORDINATION AND COLLABORATION.—
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000529:
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p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
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p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000531:
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p.000531: January 30, 2020
p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
p.000531: of this subsection), by striking ‘‘(3)’’ and all that follows through ‘‘decision making’’ and inserting
p.000531: ‘‘The term ‘medical evaluation’ means key components performed by a physician including history,
p.000531: examination, and medical decisionmaking’’’. Based on the structure of this provision of defined terms, the
p.000531: paragraph (3) enumerator was likely mistakenly left out of the inserted matter. It was re-inserted to reflect
p.000531: the probable intent of Congress.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: 533
p.000533: PUBLIC HEALTH SERVICE ACT
p.000533: Sec. 399N
p.000533:
p.000533: (1) STATEWIDE NEWBORN AND INFANT HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—For
p.000533: the purpose of carrying out subsection (a), there are authorized to be appropriated to the Health Resources and
p.000533: Services Ad- ministration $17,818,000 for fiscal year 2018, $18,173,800 for fiscal year 2019, $18,628,145
p.000533: for fiscal year 2020, $19,056,592 for fiscal year 2021, and $19,522,758 for fiscal year 2022.
...

p.000533:
p.000533:
p.000533:
p.000533: January 30, 2020
p.000533: (1) the expansion of current demographic data collection and population surveillance efforts to include
p.000533: childhood cancers nationally;
p.000533: (2) the development of a uniform reporting system under which treating physicians, hospitals, clinics, and
p.000533: States report the diagnosis of childhood cancers, including relevant associ- ated epidemiological data; and
p.000533: (3) support for the National Limb Loss Information Center to address, in part, the primary and secondary needs
p.000533: of per- sons who experience childhood cancers in order to prevent or minimize the disabling nature of these
p.000533: cancers.
p.000533: (c) COORDINATION OF ACTIVITIES.—The Secretary shall assure that activities under this section are
p.000533: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities focused on
p.000533: childhood cancers and limb loss.
p.000533: (d) DEFINITION.—For purposes of this section, the term ‘‘child- hood cancer’’ refers to a spectrum of
p.000533: different malignancies that
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: Sec. 399O PUBLIC HEALTH SERVICE ACT 534
p.000533:
p.000533: vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this
p.000533: section revise the definition of such term to the extent determined by the Secretary to be appro-
p.000533: priate.
p.000533: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000533: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000533: SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
p.000533: (a) PROGRAM.—
p.000533: (1) IN GENERAL.—Each fiscal year, the Secretary, acting through the Director of the Centers for Disease
p.000533: Control and Prevention, in coordination with the heads of other depart- ments and agencies as appropriate,
p.000533: shall support States or lo- calities for the purpose of improving the efficiency and use of PDMPs, including—
p.000533: (A) establishment and implementation of a PDMP;
p.000533: (B) maintenance of a PDMP;
p.000533: (C) improvements to a PDMP by—
p.000533: (i) enhancing functional components to work to- ward—
p.000533: (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow;
p.000533: (II) more timely inclusion of data within a PDMP;
p.000533: (III) active management of the PDMP, in part by sending proactive or unsolicited reports to pro- viders to inform
p.000533: prescribing; and
p.000533: (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates,
p.000533: to the extent that State laws allow;
p.000533: (ii) in consultation with the Office of the National Coordinator for Health Information Technology, im- proving
p.000533: the intrastate interoperability of PDMPs by—
...

p.000545: completed, the Comptroller General shall submit to Congress a report on the evaluation.
p.000545: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for the
p.000545: purpose of carrying out this section.
p.000545: SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
p.000545: (a) ESTABLISHMENT.—
p.000545: (1) IN GENERAL.—Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary,
p.000545: act- ing through the Director of the Centers for Disease Control and Prevention, may, if scientifically
p.000545: advisable—
p.000545: (A) develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as
p.000545: ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some
p.000545: cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the
p.000545: United States; and
p.000545: (B) establish a national registry for the collection and storage of such data to develop a population-based
p.000545: registry of cases in the United States of ALS and other motor neu- ron disorders that can be confused with ALS,
p.000545: misdiagnosed as ALS, and in some cases progress to ALS.
p.000545: (2) PURPOSE.—It is the purpose of the registry established under paragraph (1)(B) to—
p.000545: (A) better describe the incidence and prevalence of ALS in the United States;
p.000545: (B) examine appropriate factors, such as environ- mental and occupational, that may be associated
p.000545: with the disease;
p.000545: (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history
p.000545: of indi- viduals who are diagnosed with the disease) associated with the disease;
p.000545: (D) better examine the connection between ALS and other motor neuron disorders that can be confused with
p.000545: ALS, misdiagnosed as ALS, and in some cases progress to ALS; and
p.000545: (E) other matters as recommended by the Advisory Committee established under subsection (b).
p.000545: (b) ADVISORY COMMITTEE.—
p.000545: (1) ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the
p.000545: Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a
p.000545: committee to be known as the Ad- visory Committee on the National ALS Registry (referred to in
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000547: PUBLIC HEALTH SERVICE ACT
p.000547: Sec. 399S
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p.000549: coordination with other agencies as the Secretary determines, shall, as appro- priate—
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p.000549: (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and
p.000549: (2) incorporate information obtained through such activi- ties into an integrated surveillance system, which may
p.000549: consist of or include a registry, to be known as the National Neuro- logical Conditions Surveillance System.
p.000549: (b) RESEARCH.—The Secretary shall ensure that the National Neurological Conditions Surveillance System is
p.000549: designed in a man- ner that facilitates further research on neurological diseases.
p.000549: (c) CONTENT.—In carrying out subsection (a), the Secretary—
p.000549: (1) shall provide for the collection and storage of informa- tion on the incidence and prevalence of
p.000549: neurological diseases in the United States;
p.000549: (2) to the extent practicable, shall provide for the collection and storage of other available information on
p.000549: neurological dis- eases, including information related to persons living with neu- rological diseases who choose to
p.000549: participate, such as—
p.000549: (A) demographics, such as age, race, ethnicity, sex, ge- ographic location, family history, and other information, as
p.000549: appropriate;
p.000549: (B) risk factors that may be associated with neuro- logical diseases, such as genetic and environmental
p.000549: risk factors and other information, as appropriate; and
p.000549: (C) diagnosis and progression markers;
p.000549: (3) may provide for the collection and storage of informa- tion relevant to analysis on neurological
p.000549: diseases, such as in- formation concerning—
p.000549: (A) the natural history of the diseases;
p.000549: (B) the prevention of the diseases;
p.000549: (C) the detection, management, and treatment ap- proaches for the diseases; and
p.000549: (D) the development of outcomes measures;
p.000549: (4) may address issues identified during the consultation process under subsection (d); and
p.000549: (5) initially may address a limited number of neurological diseases.
p.000549: (d) CONSULTATION.—In carrying out this section, the Secretary shall consult with individuals with appropriate
p.000549: expertise, which may include—
p.000549: (1) epidemiologists with experience in disease surveillance or registries;
p.000549: (2) representatives of national voluntary health associa- tions that—
p.000549: (A) focus on neurological diseases; and
p.000549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
p.000553: organizations delivering population-based services, including primary care professionals, health care
p.000553: systems, professional societies, employers, community organizations, non-profit organizations, schools,
p.000553: governmental pub- lic health agencies, Indian tribes, tribal organizations and urban Indian organizations,
p.000553: medical groups, Congress and other policy- makers. Community preventive services include any policies, pro-
p.000553: grams, processes or activities designed to affect or otherwise affect- ing health at the population level.
p.000553: (b) DUTIES.—The duties of the Task Force shall include—
p.000553: (1) the development of additional topic areas for new rec- ommendations and interventions related to
p.000553: those topic areas, including those related to specific populations and age groups, as well as the social, economic
p.000553: and physical environments that can have broad effects on the health and disease of populations and health disparities
p.000553: among sub-populations and age groups;
p.000553: (2) at least once during every 5-year period, review inter- ventions and update recommendations related to
p.000553: existing topic
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: Sec. 399V PUBLIC HEALTH SERVICE ACT 554
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p.000553: January 30, 2020
p.000553:
p.000553: areas, including new or improved techniques to assess the health effects of interventions, including health
p.000553: impact assess- ment and population health modeling;
p.000553: (3) improved integration with Federal Government health objectives and related target setting for health
p.000553: improvement;
p.000553: (4) the enhanced dissemination of recommendations;
p.000553: (5) the provision of technical assistance to those health care professionals, agencies, and organizations
p.000553: that request help in implementing the Guide recommendations; and
p.000553: (6) providing yearly reports to Congress and related agen- cies identifying gaps in research and recommending
p.000553: priority areas that deserve further examination, including areas re- lated to populations and age groups
p.000553: not adequately addressed by current recommendations.
p.000553: (c) ROLE OF AGENCY.—The Director shall provide ongoing ad- ministrative, research, and technical support
p.000553: for the operations of the Task Force, including coordinating and supporting the dissemi- nation of the
p.000553: recommendations of the Task Force, ensuring ade- quate staff resources, and assistance to those
p.000553: organizations re- questing it for implementation of Guide recommendations.
p.000553: (d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE.— The Task Force shall take appropriate steps to coordinate
p.000553: its work with the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices,
p.000553: including the examination of how each task force’s recommendations interact at the nexus of clinic and
p.000553: community.
p.000553: (e) OPERATION.—In carrying out the duties under subsection (b), the Task Force shall not be subject to the
p.000553: provisions of Appen- dix 2 of title 5, United States Code.
p.000553: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary
p.000553: for each fiscal year to carry out the activities of the Task Force.
p.000553: SEC. 399V. ø280g–11¿ GRANTS TO PROMOTE POSITIVE HEALTH BEHAV- IORS AND OUTCOMES.
p.000553: (a) GRANTS AUTHORIZED.—The Director of the Centers for Dis- ease Control and Prevention, in collaboration with
p.000553: the Secretary, shall award grants to eligible entities to promote positive health behaviors and outcomes
p.000553: for populations in medically underserved communities through the use of community health workers.
...

p.000559: appropriated
p.000559: $120,000,000 for each of fiscal years 2011 and 2012, and such sums as may be necessary to carry out this
p.000559: section for each of fiscal years 2013 through 2014.
p.000559: SEC. 399V–2. ø280g–13¿ NATIONAL CONGENITAL HEART DISEASE RE- SEARCH, SURVEILLANCE, AND AWARENESS.
p.000559: (a) IN GENERAL.—The Secretary shall, as appropriate—
p.000559: (1) enhance and expand research and data collection ef- forts related to congenital heart disease, including to
p.000559: study and track the epidemiology of congenital heart disease to under- stand health outcomes for
p.000559: individuals with congenital heart disease across all ages;
p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: Sec. 399V–2 PUBLIC HEALTH SERVICE ACT 560
p.000559:
p.000559: (b) ACTIVITIES.—
p.000559: (1) IN GENERAL.—The Secretary shall carry out activities, including, as appropriate, through a national cohort
p.000559: study and a nationally-representative, population-based surveillance sys- tem, to improve the understanding of the
p.000559: epidemiology of con- genital heart disease in all age groups, with particular atten- tion to—
p.000559: (A) the incidence and prevalence of congenital heart disease in the United States;
p.000559: (B) causation and risk factors associated with, and natural history of, congenital heart disease;
p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
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p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
p.000567: (2) PARTICULAR CANCER.—The term ‘‘particular cancer’’ means one specific type of cancer or a type of cancers
p.000567: scientif- ically proven to have the same cause.
p.000567: (3) POPULATION GROUP.—The term ‘‘population group’’ means a group, for purposes of calculating cancer
p.000567: rates, de- fined by factors such as race, ethnicity, age, or gender.
p.000567: (b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUS-
p.000567: TERS.—
p.000567: (1) DEVELOPMENT OF CRITERIA.—The Secretary shall de- velop criteria for the designation of potential
p.000567: cancer clusters.
p.000567: (2) REQUIREMENTS.—The criteria developed under para- graph (1) shall consider, as appropriate—
p.000567: (A) a standard for cancer cluster identification and re- porting protocols used to determine when cancer incidence is
p.000567: greater than would be typically observed;
p.000567: (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same
p.000567: type of cancer, or types of cancers;
p.000567: (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age,
p.000567: and gender, for purposes of calculating cancer rates;
p.000567: (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create
p.000567: or obscure a potential cluster by selection of a specific area; and
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p.000567: (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected num- ber
p.000567: of cases, occurs.
p.000567: (c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER CLUSTERS.—The Secretary, in consultation with
p.000567: the Council of State and Territorial Epidemiologists and representatives of State and local health
p.000567: departments, shall develop, publish, and periodi- cally update guidelines for investigating potential cancer
p.000567: clusters. The guidelines shall—
p.000567: (1) recommend that investigations of cancer clusters—
p.000567: (A) use the criteria developed under subsection (b);
p.000567: (B) use the best available science; and
p.000567: (C) rely on a weight of the scientific evidence;
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000569: PUBLIC HEALTH SERVICE ACT
p.000569: Sec. 399V–6
p.000569:
p.000569: (2) provide standardized methods of reviewing and catego- rizing data, including from health surveillance systems and
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p.000570: SEC. 399W. ø280h¿ GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL ACTIVITY.
p.000570: (a) IN GENERAL.—The Secretary, acting though the Director of the Centers for Disease Control and Prevention,
p.000570: shall award com- petitive grants to States and political subdivisions of States for the development and
p.000570: implementation of State and community-based intervention programs to promote good nutrition and physical
p.000570: ac- tivity in children and adolescents.
p.000570: (b) ELIGIBILITY.—To be eligible to receive a grant under this section a State or political subdivision of a
p.000570: State shall prepare and submit to the Secretary an application at such time, in such man- ner, and containing such
p.000570: information as the Secretary may require, including a plan that describes—
p.000570: (1) how the applicant proposes to develop a comprehensive program of school- and community-based approaches to encour-
p.000570: age and promote good nutrition and appropriate levels of phys- ical activity with respect to children or
p.000570: adolescents in local communities;
p.000570: (2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as
p.000570: State and local school departments, State departments of health, chronic disease directors, State directors of programs
p.000570: under section 17 of the Child Nutrition Act of 1966, 5-a-day coordinators, gov- ernors councils for
p.000570: physical activity and good nutrition, and State and local parks and recreation departments; and
p.000570: (3) the manner in which the applicant will evaluate the ef- fectiveness of the program carried out under this section.
p.000570: (c) USE OF FUNDS.—A State or political subdivision of a State shall use amount received under a grant under
p.000570: this section to—
p.000570: (1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to
p.000570: reduce inactivity and improve dietary choices among children and adolescents;
p.000570: (2) expand opportunities for physical activity programs in school- and community-based settings; and
p.000570: (3) develop, implement, and evaluate programs that pro- mote good eating habits and physical activity including
p.000570: oppor- tunities for children with cognitive and physical disabilities.
p.000570: (d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an amount not to exceed 10 percent of the amount
p.000570: appropriated for a fiscal year under subsection (h) to permit the Director of the Cen- ters for Disease
p.000570: Control and Prevention to—
p.000570: (1) provide States and political subdivisions of States with technical support in the development and
p.000570: implementation of programs under this section; and
p.000570: (2) disseminate information about effective strategies and interventions in preventing and treating obesity
p.000570: through the promotion of good nutrition and physical activity.
p.000570: (e) LIMITATION ON ADMINISTRATIVE COSTS.—Not to exceed 10 percent of the amount of a grant awarded to
p.000570: the State or political subdivision under subsection (a) for a fiscal year may be used by the State or
p.000570: political subdivision for administrative expenses.
p.000570: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000571: PUBLIC HEALTH SERVICE ACT
p.000571: Sec. 399Y
p.000571:
p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
p.000571: (4) conduct research to establish the prevalence, con- sequences, and costs of childhood obesity
p.000571: and its effects in adulthood;
p.000571: (5) identify behaviors and risk factors that contribute to obesity;
p.000571: (6) evaluate materials and programs to provide nutrition education to parents and teachers of children in
p.000571: child care or pre-school and the food service staff of such child care and pre- school entities; and
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p.000575: (A) IN GENERAL.—Any provider of services that is de- termined by a State to be in violation of a
p.000575: State law de- scribed in subsection (a)(3)(B) with respect to activities carried out at a SBHC shall not be
p.000575: eligible to receive addi- tional funding under this section.
p.000575: (B) NO OVERLAPPING GRANT PERIOD.—No entity that has received funding under section 330 for a grant
p.000575: period shall be eligible for a grant under this section for with re- spect to the same grant period.
p.000575: (g) MATCHING REQUIREMENT.—
p.000575: (1) IN GENERAL.—Each eligible entity that receives a grant under this section shall provide, from non-Federal
p.000575: sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in-kind) to carry
p.000575: out the activities supported by the grant.
p.000575: (2) WAIVER.—The Secretary may waive all or part of the matching requirement described in paragraph (1) for any
p.000575: fiscal year for the SBHC if the Secretary determines that applying the matching requirement to the SBHC would
p.000575: result in serious hardship or an inability to carry out the purposes of this sec- tion.
p.000575: (h) SUPPLEMENT, NOT SUPPLANT.—Grant funds provided under this section shall be used to supplement, not
p.000575: supplant, other Fed- eral or State funds.
p.000575: (i) EVALUATION.—The Secretary shall develop and implement a plan for evaluating SBHCs and monitoring quality
p.000575: performance under the awards made under this section.
p.000575: (j) AGE APPROPRIATE SERVICES.—An eligible entity receiving funds under this section shall only provide age
p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
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p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
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p.000575: Sec. 399Z–2 PUBLIC HEALTH SERVICE ACT 576
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p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
p.000575: (A) is at risk for, shows early signs of, or has been di- agnosed with a mental illness, including a serious
p.000575: emo- tional disturbance; and
p.000575: (B) may benefit from infant and early childhood inter- vention or treatment programs or specialized preschool or
p.000575: elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise
p.000575: but would benefit from further applied development.
p.000575: (2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a human services agency or nonprofit institution that—
p.000575: (A) employs licensed mental health professionals who have specialized training and experience in infant
p.000575: and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the
p.000575: appropriate State agency, as applicable, to provide for children from in- fancy to 12 years of age mental health
p.000575: promotion, inter- vention, or treatment services; and
p.000575: (B) provides services or programs described in sub- section (a) that are evidence-based or that have
p.000575: been sci- entifically demonstrated to show promise but would benefit from further applied development.
p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
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p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
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p.000577: January 30, 2020
p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
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p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
p.000581: (ii) an urban or rural area designated by the Sec- retary as an area with a shortage of personal health
p.000581: services (as described in section 330(b)(3)(A)).
p.000581: (3) TECHNICAL ASSISTANCE.—The Secretary may award one or more grants under this section to provide
p.000581: technical assist- ance to the network of interdisciplinary training programs.
p.000581: (4) BEST PRACTICES.—The Secretary shall promote re- search into additional valid and reliable tools
p.000581: for shortening the time required to confirm or rule out a diagnosis of autism spectrum disorder or other
p.000581: developmental disabilities and de- tecting individuals with autism spectrum disorder or other de- velopmental
p.000581: disabilities at an earlier age.
p.000581: (f) INTERVENTION.—The Secretary shall promote research, through grants or contracts, which may include grants
p.000581: or contracts to research centers or networks, to determine the evidence-based practices for interventions to
p.000581: improve the physical and behavioral
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000583: PUBLIC HEALTH SERVICE ACT
p.000583: Sec. 399CC
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p.000583: health of individuals with autism spectrum disorder or other devel- opmental disabilities across the lifespan of
p.000583: such individuals, de- velop guidelines for those interventions, and disseminate informa- tion related to such
p.000583: research and guidelines.
p.000583: (g) SUNSET.—This section shall not apply after September 30, 2024.
p.000583: SEC. 399CC. ø280i–2¿ INTERAGENCY AUTISM COORDINATING COM- MITTEE.
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p.000585: their duties.
p.000585: (f) SUNSET.—This section shall not apply after September 30, 2024, and the Committee shall be terminated on
p.000585: such date.
p.000585: SEC. 399DD. ø280i–3¿ REPORTS TO CONGRESS.
p.000585: (a) PROGRESS REPORT.—
p.000585: (1) IN GENERAL.— 108Not later than 4 years after the date of enactment of the Autism CARES Act of 2019, the Secretary,
p.000585: in coordination with the Secretary of Education and the Sec- retary of Defense, shall prepare and submit
p.000585: to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce
p.000585: Committee of the House of Rep- resentatives, and make publicly available, including through posting on the
p.000585: Internet Web site of the Department of Health and Human Services, a progress report on activities related to
p.000585: autism spectrum disorder and other developmental disabilities.
p.000585: (2) CONTENTS.—The report submitted under subsection (a) shall contain—
p.000585: (A) a description of the progress made in imple- menting the provisions of the Autism CARES Act of
p.000585: 2019;
p.000585: (B) a description of the amounts expended on the im- plementation of the amendments made by the Autism
p.000585: CARES Act of 2019;
p.000585: (C) information on the incidence and prevalence of au- tism spectrum disorder, including available information on the
p.000585: prevalence of autism spectrum disorder among chil- dren and adults, and identification of any changes
p.000585: over time with respect to the incidence and prevalence of au- tism spectrum disorder;
p.000585: (D) information on the average age of diagnosis for children with autism spectrum disorder and other
p.000585: disabil- ities, including how that age may have changed over the 4-year period beginning on the date of
p.000585: enactment of the Autism CARES Act of 2019 and, as appropriate, how this age varies across population
p.000585: subgroups;
p.000585: (E) information on the average age for intervention for individuals diagnosed with autism spectrum disorder and
p.000585: other developmental disabilities, including how that age may have changed over the 4-year period beginning on the
p.000585: date of enactment of the Autism CARES Act of 2019 and, as appropriate, how this age varies across population
p.000585: sub- groups;
p.000585: (F) information on the average time between initial screening and then diagnosis or rule out for
p.000585: individuals with autism spectrum disorder or other developmental dis- abilities, as well as information on the
p.000585: average time be- tween diagnosis and evidence-based intervention for indi- viduals with autism spectrum
p.000585: disorder or other develop-
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p.000585: 108 Casing of heading for paragraph (1) so in law.
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000585: Sec. 399DD PUBLIC HEALTH SERVICE ACT 586
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p.000585: mental disabilities and, as appropriate, on how such aver- age time varies across population subgroups;
p.000585: (G) information on the effectiveness and outcomes of interventions for individuals diagnosed with autism
p.000585: spec- trum disorder, including by severity level as practicable, and other developmental disabilities and
p.000585: how the age of the individual or other factors, such as demographic char- acteristics, may affect such
p.000585: effectiveness;
p.000585: (H) information on the effectiveness and outcomes of innovative and newly developed intervention strategies for
p.000585: individuals with autism spectrum disorder or other devel- opmental disabilities;
p.000585: (I) a description of the actions taken to implement and the progress made on implementation of the strategic plan
p.000585: developed by the Interagency Autism Coordinating Com- mittee under section 399CC(b); and
p.000585: (J) information on how States use home- and commu- nity-based services and other supports to ensure that indi-
p.000585: viduals with autism spectrum disorder and other develop- mental disabilities are living, working, and
p.000585: participating in their community.
p.000585: (b) REPORT ON THE HEALTH AND WELL-BEING OF INDIVIDUALS WITH AUTISM SPECTRUM DISORDER ACROSS THEIR
p.000585: LIFESPAN.—
p.000585: (1) IN GENERAL.—Not later than 2 years after the date of enactment of the Autism CARES Act of 2019,
p.000585: the Secretary shall prepare and submit, to the Committee on Health, Edu- cation, Labor, and Pensions of
p.000585: the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning
p.000585: the health and well-being of individuals with autism spectrum disorder.
p.000585: (2) CONTENTS.—The report submitted under paragraph (1) shall contain—
p.000585: (A) demographic factors associated with the health and well-being of individuals with autism spectrum dis-
p.000585: order;
p.000585: (B) an overview of policies and programs relevant to the health and well-being of individuals with autism spec-
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p.000595: (a) PUBLIC EDUCATION CAMPAIGN.—
p.000595: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000595: shall conduct a national evidence-based education campaign to in- crease awareness of young women’s knowledge
p.000595: regarding—
p.000595: (A) breast health in young women of all racial, ethnic, and cultural backgrounds;
p.000595: (B) breast awareness and good breast health habits;
p.000595: (C) the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk
p.000595: for breast cancer based on familial, racial, ethnic, and cul- tural backgrounds such as Ashkenazi Jewish
p.000595: populations;
p.000595: (D) evidence-based information that would encourage young women and their health care professional to in-
p.000595: crease early detection of breast cancers; and
p.000595: (E) the availability of health information and other re- sources for young women diagnosed with breast cancer.
p.000595: (2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The campaign shall provide evidence-based, age-appropriate
p.000595: mes- sages and materials as developed by the Centers for Disease Control and Prevention and the Advisory
p.000595: Committee estab- lished under paragraph (4).
p.000595: (3) MEDIA CAMPAIGN.—In conducting the education cam- paign under paragraph (1), the Secretary shall award grants
p.000595: to entities to establish national multimedia campaigns oriented to young women that may include advertising through
p.000595: television, radio, print media, billboards, posters, all forms of existing and especially emerging social networking
p.000595: media, other Internet
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: Sec. 399NN PUBLIC HEALTH SERVICE ACT 596
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p.000597: Control and Prevention, shall—
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p.000597: (1) measure—
p.000597: (A) young women’s awareness regarding breast health, including knowledge of family cancer history, specific risk
p.000597: factors and early warning signs, and young women’s proactive efforts at early detection;
p.000597: (B) the number or percentage of young women uti- lizing information regarding lifestyle interventions that
p.000597: foster healthy behaviors;
p.000597: (C) the number or percentage of young women receiv- ing regular clinical breast exams; and
p.000597: (D) the number or percentage of young women who perform breast self exams, and the frequency of
p.000597: such exams, before the implementation of this section;
p.000597: (2) not less than every 3 years, measure the impact of such activities; and
p.000597: (3) submit reports to the Congress on the results of such measurements.
p.000597: (g) DEFINITION.—In this section, the term ‘‘young women’’ means women 15 to 44 years of age.
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: Sec. 401 PUBLIC HEALTH SERVICE ACT 598
p.000597:
p.000597: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out sub- sections (a), (b), (c)(1), and (d), there are
p.000597: authorized to be appro- priated $4,900,000 for each of fiscal years 2015 through 2019.
p.000597: TITLE IV—NATIONAL RESEARCH INSTITUTES PART A—NATIONAL INSTITUTES OF HEALTH
p.000597: SEC. 401. ø281¿ ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
p.000597: (a) RELATION TO PUBLIC HEALTH SERVICE.—The National Insti- tutes of Health is an agency of the Service. 1
p.000597: (b) NATIONAL RESEARCH INSTITUTES AND NATIONAL CENTERS.— The following agencies of the National Institutes of
p.000597: Health are na- tional research institutes or national centers:
p.000597: (1) The National Cancer Institute.
p.000597: (2) The National Heart, Lung, and Blood Institute.
p.000597: (3) The National Institute of Diabetes and Digestive and Kidney Diseases.
p.000597: (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
p.000597: (9) The National Eye Institute.
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p.000605: January 30, 2020
p.000605: respecting the management and operation of programs and ac- tivities within the National Institutes of Health;
p.000605: (2) shall coordinate and oversee the operation of the na- tional research institutes, national centers, and
p.000605: administrative entities within the National Institutes of Health;
p.000605: (3) shall, in consultation with the heads of the national re- search institutes and national centers, be
p.000605: responsible for pro- gram coordination across the national research institutes and national centers, including
p.000605: conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is
p.000605: balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
p.000605: (4) shall assemble accurate data to be used to assess re- search priorities, including—
p.000605: (A) information to better evaluate scientific oppor- tunity, public health burdens, and progress in
p.000605: reducing health disparities; and
p.000605: (B) data on study populations of clinical research, funded by or conducted at each national research institute
p.000605: and national center, which—
p.000605: (i) specifies the inclusion of—
p.000605: (I) women;
p.000605: (II) members of minority groups;
p.000605: (III) relevant age categories, including pedi- atric subgroups; and
p.000605: (IV) other demographic variables as the Direc- tor of the National Institutes of Health determines appropriate;
p.000605: (ii) is disaggregated by research area, condition, and disease categories; and
p.000605: (iii) is to be made publicly available on the Inter- net website of the National Institutes of Health;
p.000605: (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as
p.000605: determined by the agencies of the National Institutes of Health, and through the development,
p.000605: implementation, and updating of the strategic plan developed under subsection (m);
p.000605: (6) shall ensure that the resources of the National Insti- tutes of Health are sufficiently allocated
p.000605: for research projects identified in strategic plans;
p.000605: (7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
p.000605: (i) identify research that represents important areas of emerging scientific opportunities, rising public health chal-
p.000605: lenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting
p.000605: addi- tional research that involves collaboration between 2 or more national research institutes or
p.000605: national centers, or would otherwise benefit from strategic coordination and planning;
p.000605: (ii) include information on such research in reports under section 403; and
p.000605: (iii) in the case of such research supported with funds referred to in subparagraph (B)—
p.000605: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000611: ferred to in this subsection as the ‘‘registry data bank’’). The Director of NIH shall ensure that the
p.000611: reg- istry data bank is made publicly available through the Internet.
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: 613
p.000613: PUBLIC HEALTH SERVICE ACT
p.000613: Sec. 402
p.000613:
p.000613: (ii) CONTENT.—The clinical trial information re- quired to be submitted under this paragraph for an
p.000613: applicable clinical trial shall include—
p.000613: (I) descriptive information, including—
p.000613: (aa) a brief title, intended for the lay pub-
p.000613: lic;
p.000613: (bb) a brief summary, intended for the lay
p.000613: public;
p.000613: (cc) the primary purpose; (dd) the study design;
p.000613: (ee) for an applicable drug clinical trial, the study phase;
p.000613: (ff) study type;
p.000613: (gg) the primary disease or condition being studied, or the focus of the study;
p.000613: (hh) the intervention name and interven- tion type;
p.000613: (ii) the study start date;
p.000613: (jj) the expected completion date;
p.000613: (kk) the target number of subjects; and (ll) outcomes, including primary and sec-
p.000613: ondary outcome measures;
p.000613: (II) recruitment information, including— (aa) eligibility criteria;
p.000613: (bb) gender; (cc) age limits;
p.000613: (dd) whether the trial accepts healthy vol- unteers;
p.000613: (ee) overall recruitment status; (ff) individual site status; and
p.000613: (gg) in the case of an applicable drug clin- ical trial, if the drug is not approved under section 505 of
p.000613: the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.000613: there is ex- panded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act
p.000613: for those who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such
p.000613: access;
p.000613: (III) location and contact information, includ- ing—
p.000613:
p.000613:
p.000613: and
p.000613: (aa) the name of the sponsor;
p.000613: (bb) the responsible party, by official title;
p.000613: (cc) the facility name and facility contact
p.000613:
p.000613:
p.000613:
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p.000613:
p.000613: January 30, 2020
p.000613: information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.000613: through which such location in- formation may be accessed); and
p.000613: (IV) administrative data (which the Secretary may make publicly available as necessary), includ- ing—
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: January 30, 2020
p.000613:
p.000613: (aa) the unique protocol identification number;
p.000613: (bb) other protocol identification numbers, if any; and
p.000613: (cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
p.000613: (iii) MODIFICATIONS.—The Secretary may by regu- lation modify the requirements for clinical trial infor- mation
p.000613: under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not
p.000613: reduce such clinical trial information.
p.000613: (B) FORMAT AND STRUCTURE.—
p.000613: (i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to key- word
p.000613: searching, search the entries in the registry data bank by 1 or more of the following criteria:
p.000613: (I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH)
p.000613: descriptors.
p.000613: (II) The name of the intervention, including any drug or device being studied in the clinical trial.
p.000613: (III) The location of the clinical trial.
p.000613: (IV) The age group studied in the clinical trial, including pediatric subpopulations.
p.000613: (V) The study phase of the clinical trial.
p.000613: (VI) The sponsor of the clinical trial, which may be the National Institutes of Health or an- other
p.000613: Federal agency, a private industry source, or a university or other organization.
p.000613: (VII) The recruitment status of the clinical trial.
p.000613: (VIII) The National Clinical Trial number or other study identification for the clinical trial.
p.000613: (ii) ADDITIONAL SEARCHABLE CATEGORY.—Not later than 18 months after the date of the enactment of the Food and Drug
p.000613: Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries
p.000613: of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary
p.000613: or secondary outcome.
p.000613: (iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the
p.000613: registry data bank by such other elements as the Director deems necessary on an ongoing basis.
p.000613: (iv) FORMAT.—The Director of the NIH shall en- sure that the registry data bank is easily used by the public,
p.000613: and that entries are easily compared.
p.000613: (C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug
p.000613: clin- ical trial for a serious or life-threatening disease or condi- tion, that is initiated after, or is
p.000613: ongoing on the date that is 90 days after, the date of the enactment of the Food and
p.000613: As Amended Through P.L. 116-94, Enacted December 20, 2019
...

p.000633: of the National Institutes of Health Reform Act of 2006. Each such report shall include the following
p.000633: informa- tion:
p.000633: (1) An assessment of the state of biomedical and behav- ioral research.
p.000633: (2) A description of the activities conducted or supported by the agencies of the National Institutes of
p.000633: Health and poli- cies respecting the programs of such agencies.
p.000633: (3) A description of intra-National Institutes of Health ac- tivities, including—
p.000633: (A) identification of the percentage of funds made available by each national research institute
p.000633: and national center with respect to each applicable fiscal year for con- ducting or supporting research
p.000633: that involves collaboration between the institute or center and 1 or more other na- tional research
p.000633: institutes or national centers; and
p.000633: (B) recommendations for promoting coordination of in- formation among the centers of excellence.
p.000633: (4) A catalog of all the research activities of the agencies, prepared in accordance with the following:
p.000633: (A) The catalog shall, for each such activity—
p.000633: (i) identify the agency or agencies involved;
p.000633: (ii) state whether the activity was carried out di- rectly by the agencies or was supported by the
p.000633: agen- cies and describe to what extent the agency was in- volved; and
p.000633: (iii) identify whether the activity was carried out through a center of excellence.
p.000633: (B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by
p.000633: demographic variables, including biological and social variables and rel- evant age categories (such as pediatric
p.000633: subgroups), and de- terminants of health, that contribute to research on minor- ity health and health disparities.
p.000633: (C) Research activities listed in the catalog shall in- clude, where applicable, the following:
p.000633: (i) Epidemiological studies and longitudinal stud-
p.000633:
p.000633:
p.000633: January 30, 2020
p.000633: ies.
p.000633:
p.000633: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000633:
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p.000635: 635
p.000635: PUBLIC HEALTH SERVICE ACT
p.000635: Sec. 403
p.000635:
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p.000635: January 30, 2020
p.000635: (ii) Disease registries, information clearinghouses, and other data systems.
p.000635: (iii) Public education and information campaigns.
p.000635: (iv) Training activities, including—
p.000635: (I) National Research Service Awards and Clinical Transformation Science Awards;
p.000635: (II) graduate medical education programs, in- cluding information on the number and type of graduate
p.000635: degrees awarded during the period in which the programs received funding under this title;
p.000635: (III) investigator-initiated awards for postdoctoral training and postdoctoral training funded
p.000635: through research grants;
p.000635: (IV) a breakdown by demographic variables and other appropriate categories; and
p.000635: (V) an evaluation and comparison of outcomes and effectiveness of various training programs.
p.000635: (v) Clinical trials, including a breakdown of par- ticipation by study populations and demographic vari- ables,
p.000635: including relevant age categories (such as pedi- atric subgroups), information submitted by each na- tional
p.000635: research institute and national center to the Di- rector of National Institutes of Health under section 492B(f),
p.000635: and such other information as may be nec- essary to demonstrate compliance with section 492B and other
p.000635: applicable requirements regarding inclusion of demographic groups.
p.000635: (vi) Translational research activities with other agencies of the Public Health Service.
p.000635: (5) A summary of the research activities throughout the agencies, which summary shall be organized by
p.000635: the following categories, where applicable:
p.000635: (A) Cancer.
p.000635: (B) Neurosciences.
p.000635: (C) Life stages, human development, and rehabilita- tion.
p.000635: (D) Organ systems.
p.000635: (E) Autoimmune diseases.
p.000635: (F) Genomics.
p.000635: (G) Molecular biology and basic science.
p.000635: (H) Technology development.
p.000635: (I) Chronic diseases, including pain and palliative care.
p.000635: (J) Infectious diseases and bioterrorism.
p.000635: (K) Minority health and health disparities.
p.000635: (L) Such additional categories as the Director deter- mines to be appropriate.
p.000635: (6) A review of each entity receiving funding under this title in its capacity as a center of excellence (in
p.000635: this paragraph referred to as a ‘‘center of excellence’’), including the fol- lowing—
p.000635: (A) an evaluation of the performance and research out- comes of each center of excellence; and
p.000635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000635:
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p.000645: (B) The applicant provides assurances satisfactory to the Director that—
p.000645: (i) for not less than 20 years after completion of the construction involved, the facility will be used
p.000645: for the purposes of the research for which it is to be con- structed;
p.000645: (ii) sufficient funds will be available to meet the non-Federal share of the cost of constructing the facil-
p.000645: ity;
p.000645: (iii) sufficient funds will be available, when con- struction is completed, for the effective use of the facil-
p.000645: ity for the research for which it is being constructed; and
p.000645: (iv) the proposed construction will expand the ap- plicant’s capacity for research, or is necessary to im-
p.000645: prove or maintain the quality of the applicant’s re- search.
p.000645: (C) The applicant meets reasonable qualifications es- tablished by the Director with respect to—
p.000645: (i) the relative scientific and technical merit of the applications, and the relative effectiveness of the pro-
p.000645: posed facilities, in expanding the capacity for bio- medical or behavioral research and in
p.000645: improving the quality of such research;
p.000645: (ii) the quality of the research or training, or both, to be carried out in the facilities involved;
p.000645: (iii) the congruence of the research activities to be carried out within the facility with the research and
p.000645: investigator manpower needs of the United States; and
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p.000645: January 30, 2020
p.000645: (iv) the age and condition of existing research fa- cilities.
p.000645: (D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of
p.000645: the applicant.
p.000645: (2) INSTITUTIONS OF EMERGING EXCELLENCE.—From the amount appropriated to carry out this section for a fiscal
p.000645: year up to $50,000,000, the Director of NIH, acting through the Of- fice of the Director of NIH, shall make available
p.000645: 25 percent of such amount, and from the amount appropriated to carry out this section for a fiscal year that
p.000645: is over $50,000,000, the Direc-
p.000645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000647: 647
p.000647: PUBLIC HEALTH SERVICE ACT
p.000647: Sec. 404I
p.000647:
p.000647: tor of NIH, acting through the Office of the Director of NIH, shall make available up to 25 percent
p.000647: of such amount, for grants under subsection (a) to applicants that in addition to meeting the
p.000647: requirements established in paragraph (1), have demonstrated emerging excellence in biomedical or behavioral
p.000647: research, as follows:
p.000647: (A) The applicant has a plan for research or training advancement and possesses the ability to carry
p.000647: out the plan.
p.000647: (B) The applicant carries out research and research training programs that have a special relevance to a prob-
p.000647: lem, concern, or unmet health need of the United States.
...

p.000675: pediatric population.
p.000675: (2) WRITTEN REQUEST TO HOLDERS OF APPROVED APPLICA- TIONS.—The Commissioner of Food and Drugs, in
p.000675: consultation with the Director of the National Institutes of Health, may issue a written request based on
p.000675: the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which
p.000675: shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug iden- tified under
p.000675: subsection (a) to all holders of an approved appli- cation for the drug. Such a written request shall be made
p.000675: in a manner equivalent to the manner in which a written request
p.000675: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000675:
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p.000675: Sec. 409I PUBLIC HEALTH SERVICE ACT 676
p.000675:
p.000675: is made under subsection (b) or (c) of section 505A of the Fed- eral Food, Drug, and Cosmetic Act or section
p.000675: 351(m) of this Act, including with respect to information provided on the pe- diatric studies to be
p.000675: conducted pursuant to the request and using appropriate formulations for each age group for which the
p.000675: study is requested.
p.000675: (3) REQUESTS FOR PROPOSALS.—If the Commissioner of Food and Drugs does not receive a response to
p.000675: a written re- quest issued under paragraph (2) not later than 30 days after the date on which a
p.000675: request was issued, the Secretary, acting through the Director of the National Institutes of Health and
p.000675: in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to
p.000675: conduct the pediatric studies described in the written request in accordance with subsection (b).
p.000675: (4) DISQUALIFICATION.—A holder that receives a first right of refusal shall not be entitled to respond to a request
p.000675: for pro- posals under paragraph (3).
p.000675: (5) CONTRACTS, GRANTS, OR OTHER FUNDING MECHA- NISMS.—A contract, grant, or other funding may be
p.000675: awarded under this section only if a proposal is submitted to the Sec- retary in such form and manner,
p.000675: and containing such agree- ments, assurances, and information as the Secretary deter- mines to be necessary
p.000675: to carry out this section.
p.000675: (6) REPORTING OF STUDIES.—
p.000675: (A) IN GENERAL.—On completion of a pediatric study in accordance with an award under this section, a
p.000675: report concerning the study shall be submitted to the Director of the National Institutes of Health and the
p.000675: Commissioner of Food and Drugs. The report shall include all data gen- erated in connection with the
p.000675: study, including a written request if issued.
p.000675: (B) AVAILABILITY OF REPORTS.—
p.000675: (i) IN GENERAL.—Each report submitted under subparagraph (A) shall be considered to be in the pub- lic domain
...

p.000691: (9) REPORT.—Not later than 4 years after the date of en- actment of the Childhood Cancer Survivorship,
p.000691: Treatment, Ac- cess, and Research Act of 2018, the Secretary shall submit to Congress a report on—
p.000691: (A) the number of biospecimens and corresponding clinical demographic data collected through the biospeci-
p.000691: men research efforts supported under paragraph (1);
p.000691: (B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;
p.000691: (C) barriers to the collection of biospecimens and cor- responding clinical demographic data;
p.000691: (D) barriers experienced by researchers or health care professionals in accessing the biospecimens and cor-
p.000691: responding clinical demographic data necessary for use in research; and
p.000691: (E) recommendations with respect to improving the biospecimen and biorepository research efforts under this
p.000691: subsection.
p.000691: (10) DEFINITIONS.—For purposes of this subsection:
p.000691: (A) AWARD.—The term ‘‘award’’ includes a grant, con- tract, or cooperative agreement determined by the
p.000691: Sec- retary.
p.000691: (B) BIOSPECIMEN.—The term ‘‘biospecimen’’ includes—
p.000691: (i) solid tumor tissue or bone marrow;
p.000691: (ii) normal or control tissue;
p.000691: (iii) blood and plasma;
p.000691: (iv) DNA and RNA extractions;
p.000691: (v) familial DNA; and
p.000691: (vi) any other sample relevant to cancer research, as required by the Secretary.
p.000691: (C) CLINICAL AND DEMOGRAPHIC INFORMATION.—The term ‘‘clinical and demographic information’’ includes—
p.000691: (i) date of diagnosis;
p.000691: (ii) age at diagnosis;
p.000691: (iii) the patient’s sex, race, ethnicity, and environ- mental exposures;
p.000691: (iv) extent of disease at enrollment;
p.000691: (v) site of metastases;
p.000691: (vi) location of primary tumor coded;
p.000691: (vii) histologic diagnosis;
p.000691: (viii) tumor marker data when available;
p.000691: (ix) treatment and outcome data;
p.000691: (x) information related to specimen quality; and
p.000691: (xi) any other applicable information required by the Secretary.
p.000691: (b) IMPROVING CARE FOR PEDIATRIC CANCER SURVIVORS.—
p.000691: (1) RESEARCH ON PEDIATRIC CANCER SURVIVORSHIP.—The Director of NIH, in coordination with ongoing
p.000691: research activi- ties, may continue to conduct or support pediatric cancer survi- vorship research including in any of
p.000691: the following areas:
p.000691: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000693: 693
p.000693: PUBLIC HEALTH SERVICE ACT
p.000693: Sec. 417F
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p.000707: SEC. 427. ø285c–1¿ (a) The Director of the Institute shall (1) establish the National Diabetes Data
p.000707: System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations
p.000707: with diabetes, including, where possible, data involving general populations for the purpose of detection
p.000707: of indi- viduals with a risk of developing diabetes, and (2) establish the Na- tional Diabetes Information
p.000707: Clearinghouse to facilitate and en- hance knowledge and understanding of diabetes on the part of health
p.000707: professionals, patients, and the public through the effective dissemination of information.
p.000707: (b) The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the
p.000707: collection, storage, anal- ysis, retrieval, and dissemination of data derived from patient pop- ulations with
p.000707: digestive diseases, including, where possible, data in- volving general populations for the purpose of detection of
p.000707: individ- uals with a risk of developing digestive diseases, and (2) establish the National Digestive
p.000707: Diseases Information Clearinghouse to fa- cilitate and enhance knowledge and understanding of digestive dis- eases
p.000707: on the part of health professionals, patients, and the public through the effective dissemination of
p.000707: information.
p.000707: (c) The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases Data System for the
p.000707: collection, stor- age, analysis, retrieval, and dissemination of data derived from pa- tient populations with kidney
p.000707: and urologic diseases, including, where possible, data involving general populations for the purpose
p.000707: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000707:
p.000707:
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p.000707:
p.000707: Sec. 428 PUBLIC HEALTH SERVICE ACT 708
p.000707:
p.000707: of detection of individuals with a risk of developing kidney and uro- logic diseases, and (2) establish the
p.000707: National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and
p.000707: understanding of kidney and urologic diseases on the part of health professionals, patients, and the
p.000707: public through the effective dissemination of information.
p.000707: DIVISION DIRECTORS FOR DIABETES, ENDOCRINOLOGY, AND META- BOLIC DISEASES, DIGESTIVE DISEASES AND
p.000707: NUTRITION, AND KIDNEY, UROLOGIC, AND HEMATOLOGIC DISEASES
p.000707: SEC. 428. ø285c–2¿ (a)(1) In the Institute there shall be a Divi- sion Director for Diabetes, Endocrinology, and
p.000707: Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Di- vision Director for Kidney,
p.000707: Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the
p.000707: Institute, shall be responsible for—
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p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
p.000753: (C) study the effects of discrimination on institutions and individuals, including majority institutions
p.000753: and indi- viduals;
p.000753: (D) support and develop research designed to elimi- nate institutional discrimination; and
p.000753: (E) provide increased emphasis on the concerns of women and minority populations in training programs,
p.000753: service delivery programs, and research endeavors of the Institute.
p.000753: ASSOCIATE DIRECTOR FOR PREVENTION
p.000753: SEC. 464S. ø285p–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000753: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000753: concerning the prevention of mental disorder. The Associate Director shall be appointed by the Director
...

p.000785: (8) assist in the administration of section 492B with re- spect to the inclusion of women as subjects in
p.000785: clinical research; and
p.000785: (9) prepare the report required in section 486B.
p.000785: (c) COORDINATING COMMITTEE.—
p.000785: (1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the
p.000785: Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘‘Coordinating
p.000785: Committee’’).
p.000785: (2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the
p.000785: senior-level staff designees of the Directors).
p.000785: (3) The Director of the Office shall serve as the chair of the Coordinating Committee.
p.000785: (4) With respect to research on women’s health, the Co- ordinating Committee shall assist the Director
p.000785: of the Office in—
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p.000785: (A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to
p.000785: ade- quately support the research;
p.000785: (B) identifying needs regarding the coordination of re- search activities, including intramural and
p.000785: extramural multidisciplinary activities;
p.000785: (C) supporting the development of methodologies to determine the circumstances in which obtaining data
p.000785: spe- cific to women (including data relating to the age of women and the membership of women in
p.000785: ethnic or racial
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000787: PUBLIC HEALTH SERVICE ACT
p.000787: Sec. 486
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p.000787: groups) is an appropriate function of clinical trials of treat- ments and therapies;
p.000787: (D) supporting the development and expansion of clin- ical trials of treatments and therapies for which obtaining such
p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
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p.000787: (iii) the level of funding needed for such research.
p.000787: (B) The report required in subparagraph (A) shall be sub- mitted to the Director of NIH for inclusion
p.000787: in the report re- quired in section 403.
p.000787: (e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The Secretary, acting through the Assistant Secretary for
p.000787: Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are
p.000787: represented among senior physi- cians and scientists of the national research institutes and among
p.000787: physicians and scientists conducting research with funds provided by such institutes, and as appropriate,
p.000787: carry out activities to in- crease the extent of such representation.
p.000787: (f) DEFINITIONS.—For purposes of this part:
p.000787: (1) The term ‘‘women’s health conditions’’, with respect to women of all age, ethnic, and racial groups, means
p.000787: all diseases, disorders, and conditions (including with respect to mental health)—
p.000787: (A) unique to, more serious, or more prevalent in women;
p.000787: (B) for which the factors of medical risk or types of medical intervention are different for women, or for
p.000787: which it is unknown whether such factors or types are different for women; or
p.000787: (C) with respect to which there has been insufficient clinical research involving women as subjects or
p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
p.000787: national research institutes. Information from the data sys- tem shall be available through information systems
p.000787: available to health care professionals and providers, researchers, and members of the public.
p.000787: (2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental
p.000787: treatments that have been developed for research on women’s health. Such registry shall include information on subject
p.000787: eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal
p.000787: investigators of such clinical trials shall provide this information to the registry within 30 days after it is avail-
p.000787: able. Once a trial has been completed, the principal investi- gator shall provide the registry with
p.000787: information pertaining to the results, including potential toxicities or adverse effects as- sociated with the
p.000787: experimental treatment or treatments evalu- ated.
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000789: PUBLIC HEALTH SERVICE ACT
p.000789: Sec. 487
p.000789:
p.000789: (b) CLEARINGHOUSE.—The Director of NIH, in consultation with the Director of the Office and with
p.000789: the National Library of Medicine, shall establish, maintain, and operate a program to pro- vide information on
p.000789: research and prevention activities of the na- tional research institutes that relate to research on
p.000789: women’s health.
p.000789: SEC. 486B. ø287d–2¿ BIENNIAL REPORT.
p.000789: (a) IN GENERAL.—With respect to research on women’s health, the Director of the Office shall, not later than
p.000789: February 1, 1994, and biennially thereafter, prepare a report—
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p.000831: (3) STUDY.—
p.000831: (A) The Secretary, acting through the Assistant Sec- retary for Personnel, shall conduct a study to evaluate the
p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
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p.000851: (ii) the applicant will enter into an agreement with a public or nonprofit private entity under which
p.000851: the entity will provide the service, and the entity has entered into such a participation agreement plan
p.000851: and is qualified to receive such payments.
p.000851: (B) WAIVER OF PARTICIPATION AGREEMENTS.—
p.000851: (i) IN GENERAL.—In the case of an entity making an agreement pursuant to subparagraph (A)(ii) regard- ing the
p.000851: provision of services, the requirement estab- lished in such subparagraph regarding a participation agreement
p.000851: shall be waived by the Director if the entity does not, in providing health care services, impose a charge or
p.000851: accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or
p.000851: under any Federal or State health benefits plan.
p.000851: (ii) DONATIONS.—A determination by the Director of whether an entity referred to in clause (i) meets the criteria
p.000851: for a waiver under such clause shall be made without regard to whether the entity accepts voluntary donations
p.000851: regarding the provision of services to the public.
p.000851: (C) NONAPPLICATION OF CERTAIN REQUIREMENTS.— With respect to any authorized service that is
p.000851: available pursuant to the State plan described in subparagraph (A), the requirements established in such
p.000851: subparagraph shall not apply to the provision of any such service by an insti- tution for mental diseases to an
p.000851: individual who has at- tained 21 years of age and who has not attained 65 years of age. For purposes of the
p.000851: preceding sentence, the term ‘‘institution for mental diseases’’ has the meaning given such term in section
p.000851: 1905(i) of the Social Security Act.
p.000851: (f) REQUIREMENT OF MATCHING FUNDS.—
p.000851: (1) IN GENERAL.—With respect to the costs of the program to be carried out by an applicant pursuant to subsection (a),
p.000851: a funding agreement for an award under such subsection is that the applicant will make available (directly or
p.000851: through dona- tions from public or private entities) non-Federal contributions toward such costs in an amount that—
p.000851: (A) for the first fiscal year for which the applicant re- ceives payments under an award under such subsection, is not
p.000851: less than $1 for each $9 of Federal funds provided in the award;
p.000851: (B) for any second such fiscal year, is not less than $1 for each $9 of Federal funds provided in the award; and
p.000851: (C) for any subsequent such fiscal year, is not less than $1 for each $3 of Federal funds provided in
p.000851: the award.
p.000851: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required in paragraph (1) may be in cash or
p.000851: in kind, fairly evaluated, including plant, equipment, or serv- ices. Amounts provided by the Federal
p.000851: Government, or services assisted or subsidized to any significant extent by the Federal
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000851: Sec. 508 PUBLIC HEALTH SERVICE ACT 852
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p.000863: assistance programs, and targeted capacity response programs under this section to the general public and
p.000863: to health professionals. The Secretary shall make every effort to pro- vide linkages between the findings of supported
p.000863: projects and State agencies responsible for carrying out substance use disorder pre- vention and treatment
p.000863: programs.
p.000863: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000863: $211,148,000 for each of fiscal years 2018 through 2022.
p.000863: øSection 517 was repealed by section 9017 of Public Law 114–
p.000863: 255. Section 518 was repealed by section 3202(b) of Public Law 106–310 (114 Stat. 1210). Section 519A
p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
p.000863: (3) The term ‘‘youth’’ means persons under the age of 21.
p.000863: (4) The term ‘‘IOM report’’ means the report released in September 2003 by the National Research Council,
p.000863: Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collec- tive Responsibility’’.
p.000863: (b) SENSE OF CONGRESS.—It is the sense of the Congress that:
p.000863: (1) A multi-faceted effort is needed to more successfully ad- dress the problem of underage drinking in the
p.000863: United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to
p.000863: making progress. This Act recognizes the need for a focused national effort, and addresses particulars of the Federal
p.000863: portion of that effort, as well as Fed- eral support for State activities.
p.000863: (2) The Secretary of Health and Human Services shall con- tinue to conduct research and collect data on the
p.000863: short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ
p.000863: systems.
p.000863: (3) States and communities, including colleges and univer- sities, are encouraged to adopt comprehensive
p.000863: prevention ap- proaches, including—
p.000863: (A) evidence-based screening, programs and curricula;
p.000863: (B) brief intervention strategies;
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
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p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
p.000865: foundations, and alcohol bev- erage industry trade associations and companies.
p.000865: (F) ANNUAL REPORT.—
p.000865: (i) IN GENERAL.—The Secretary, on behalf of the Committee, shall annually submit to the Congress a report
p.000865: that summarizes—
p.000865: (I) all programs and policies of Federal agen- cies designed to prevent and reduce underage
p.000865: drinking;
p.000865: (II) the extent of progress in preventing and reducing underage drinking nationally;
p.000865: (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
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p.000865: (IV) such other information regarding under- age drinking as the Secretary determines to be ap- propriate.
p.000865: (ii) CERTAIN INFORMATION.—The report under clause (i) shall include information on the following:
p.000865: (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not
p.000865: limited to Monitoring the Future, Youth Risk Behavior Surveillance System, the Na- tional Survey on Drug
p.000865: Use and Health, and the Fatality Analysis Reporting System.
p.000865: (II) Measures of the availability of alcohol from commercial and non-commercial sources to underage
p.000865: populations.
p.000865: (III) Measures of the exposure of underage populations to messages regarding alcohol in ad- vertising and
p.000865: the entertainment media as re- ported by the Federal Trade Commission.
p.000865: (IV) Surveillance data, including information on the onset and prevalence of underage drinking, consumption
p.000865: patterns and the means of underage access. The Secretary shall develop a plan to im- prove the collection,
p.000865: measurement and consistency of reporting Federal underage alcohol data.
p.000865: (V) Any additional findings resulting from re- search conducted or supported under subsection (f).
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000869: Sec. 519B PUBLIC HEALTH SERVICE ACT 870
p.000869:
p.000869: (I) reach out to students and community stakeholders;
p.000869: (II) promote the purpose of this paragraph;
p.000869: (III) address the range of needs of the stu- dents and the surrounding communities; and
p.000869: (IV) address community norms for underage students regarding alcohol use; and
p.000869: (viii) such additional information as required by the Secretary.
p.000869: (C) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000869: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph (B).
p.000869: (D) ACCOUNTABILITY.—On the date on which the Sec- retary first publishes a notice in the Federal Register solic-
p.000869: iting applications for grants under this paragraph, the Sec- retary shall include in the notice achievement
p.000869: indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
p.000869: (i) to measure the impact that the statewide coali- tions assisted under this paragraph are having on the institutions
p.000869: of higher education and the surrounding communities, including changes in the number of inci- dents of any kind in
p.000869: which students have abused alco- hol or consumed alcohol while under the age of 21 (in- cluding violations, physical
p.000869: assaults, sexual assaults, reports of intimidation, disruptions of school functions, disruptions of student studies,
p.000869: mental health referrals, illnesses, or deaths);
p.000869: (ii) to measure the quality and accessibility of the programs or information offered by the eligible entity; and
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p.000869: January 30, 2020
p.000869: (iii) to provide such other measures of program impact as the Secretary determines appropriate.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: and not supplant, Federal and non-Federal funds available for carrying out the activities described in this paragraph.
p.000869: (F) DEFINITIONS.—For purposes of this paragraph:
p.000869: (i) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, institution of higher education, or non- profit
p.000869: entity.
p.000869: (ii) INSTITUTION OF HIGHER EDUCATION.—The term ‘‘institution of higher education’’ has the meaning given
p.000869: the term in section 101(a) of the Higher Edu- cation Act of 1965 (20 U.S.C. 1001(a)).
p.000869: (iii) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Education.
p.000869: (iv) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Common- wealth of
...

p.000871: higher education throughout the State and in the surrounding communities.
p.000871: (vi) SURROUNDING COMMUNITY.—The term ‘‘sur- rounding community’’ means the community—
p.000871: (I) that surrounds an institution of higher education participating in a statewide coalition;
p.000871: (II) where the students from the institution of higher education take part in the community; and
p.000871: (III) where students from the institution of higher education live in off-campus housing.
p.000871: (G) ADMINISTRATIVE EXPENSES.—Not more than 5 per- cent of a grant under this paragraph may be expended for
p.000871: administrative expenses.
p.000871: (H) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this
p.000871: paragraph
p.000871: $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
p.000871: (f) ADDITIONAL RESEARCH.—
p.000871: (1) ADDITIONAL RESEARCH ON UNDERAGE DRINKING.—
p.000871: (A) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, collect data, and
p.000871: conduct or support research that is not duplicative of research cur- rently being conducted or supported by
p.000871: the Department of Health and Human Services, on underage drinking, with respect to the following:
p.000871: (i) Comprehensive community-based programs or strategies and statewide systems to prevent and re- duce
p.000871: underage drinking, across the underage years from early childhood to age 21, including programs funded and
p.000871: implemented by government entities, pub- lic health interest groups and foundations, and alcohol beverage companies and
p.000871: trade associations.
p.000871: (ii) Annually obtain and report more precise infor- mation than is currently collected on the scope of the
p.000871: underage drinking problem and patterns of underage alcohol consumption, including improved knowledge
p.000871: about the problem and progress in preventing, reduc- ing and treating underage drinking; as well as
p.000871: infor- mation on the rate of exposure of youth to advertising and other media messages encouraging and discour-
p.000871: aging alcohol consumption.
p.000871: (iii) Compiling information on the involvement of alcohol in unnatural deaths of persons ages 12 to 20
p.000871: in the United States, including suicides, homicides, and unintentional injuries such as falls, drownings,
p.000871: burns, poisonings, and motor vehicle crash deaths.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: Sec. 519B PUBLIC HEALTH SERVICE ACT 872
p.000871:
p.000871: (B) CERTAIN MATTERS.—The Secretary shall carry out activities toward the following objectives with respect
p.000871: to underage drinking:
p.000871: (i) Obtaining new epidemiological data within the national or targeted surveys that identify alcohol use
p.000871: and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a
p.000871: result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol
p.000871: exposure.
p.000871: (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
p.000871: paragraph (2) by—
p.000871: (A) providing training to health care providers;
p.000871: (B) disseminating best practices, including culturally and linguistically appropriate best practices, as
p.000871: appro- priate, and developing and distributing materials; and
p.000871: (C) supporting other activities, as determined appro- priate by the Assistant Secretary.
p.000871: (4) APPLICATION.—To be eligible to receive a grant under this subsection, an entity shall submit an
p.000871: application to the Assistant Secretary at such time, and in such manner, and ac- companied by such information as the
p.000871: Assistant Secretary may require. Each application shall include—
p.000871: (A) a description of the entity;
p.000871: (B) a description of activities to be completed;
p.000871:
p.000871:
p.000871:
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p.000871: January 30, 2020
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p.000873: PUBLIC HEALTH SERVICE ACT
p.000873: Sec. 519D
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p.000873: January 30, 2020
p.000873: (C) a description of how the services specified in para- graphs (2) and (3) will be carried out and the qualifications
p.000873: for providing such services; and
p.000873: (D) a timeline for the completion of such activities.
p.000873: (5) DEFINITIONS.—For the purpose of this subsection:
p.000873: (A) BRIEF INTERVENTION.—The term ‘‘brief interven- tion’’ means, after screening a patient, providing the
p.000873: pa- tient with brief advice and other brief motivational en- hancement techniques designed to increase the
p.000873: insight of the patient regarding the patient’s alcohol use, and any re- alized or potential consequences of such
p.000873: use, to effect the desired related behavioral change.
p.000873: (B) CHILDREN AND ADOLESCENTS.—The term ‘‘children and adolescents’’ means any person under 21 years of age.
p.000873: (C) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an entity consisting of pediatric health care
p.000873: pro- viders and that is qualified to support or provide the ac- tivities identified in paragraph (2).
p.000873: (D) PEDIATRIC HEALTH CARE PROVIDER.—The term ‘‘pe- diatric health care provider’’ means a provider of
p.000873: primary health care to individuals under the age of 21 years.
p.000873: (E) SCREENING.—The term ‘‘screening’’ means using validated patient interview techniques to identify and
p.000873: as- sess the existence and extent of alcohol use in a patient.
p.000873: øSection 519C was repealed by section 9017 of Public Law 114–255.¿
p.000873: SEC. 519D. ø290bb–25d¿ CENTERS OF EXCELLENCE ON SERVICES FOR INDIVIDUALS WITH FETAL ALCOHOL SYNDROME AND AL-
p.000873: COHOL-RELATED BIRTH DEFECTS AND TREATMENT FOR INDIVIDUALS WITH SUCH CONDITIONS AND THEIR FAMI- LIES.
p.000873: (a) IN GENERAL.—The Secretary shall make awards of grants, cooperative agreements, or contracts to public
p.000873: or nonprofit private entities for the purposes of establishing not more than four centers of excellence to study
p.000873: techniques for the prevention of fetal alcohol syndrome and alcohol-related birth defects and adaptations of inno-
p.000873: vative clinical interventions and service delivery improvements for the provision of comprehensive services to
p.000873: individuals with fetal al- cohol syndrome or alcohol-related birth defects and their families and for providing
p.000873: training on such conditions.
p.000873: (b) USE OF FUNDS.—An award under subsection (a) may be used to—
p.000873: (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for
p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
...

p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
p.000883: private nonprofit organizations, political subdivisions, consortia of political subdivi- sions, consortia of
p.000883: States, or Federally recognized Indian tribes or tribal organizations to design early intervention and
p.000883: prevention strategies that will complement the State-sponsored statewide or tribal youth suicide early
p.000883: intervention and prevention strategies developed pursuant to section 520E.
p.000883: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall ensure that activities under this
p.000883: section are coordi- nated with the relevant Department of Health and Human Services agencies and suicide working
p.000883: groups.
p.000883: (c) REQUIREMENTS.—A public organization, private nonprofit organization, political subdivision, consortium of
p.000883: political subdivi- sions, consortium of States, or federally recognized Indian tribe or tribal organization
p.000883: desiring a grant, contract, or cooperative agree- ment under this section shall demonstrate that the suicide preven-
...

p.000897: (2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA- TION.—The information and resources provided by the
p.000897: Sec- retary under paragraph (1) shall, as appropriate, be made available to States, political
p.000897: subdivisions of States, Indian tribes or tribal organizations (as defined in section 4 of the In- dian
p.000897: Self-Determination and Education Assistance Act), out- patient mental health and addiction treatment
p.000897: centers, com- munity mental health centers that meet the criteria under sec- tion 1913(c), certified community
p.000897: behavioral health clinics de- scribed in section 223 of the Protecting Access to Medicare Act of 2014, primary care
p.000897: organizations such as Federally qualified health centers or rural health clinics as defined in section
p.000897: 1861(aa) of the Social Security Act, other community-based or- ganizations, or other entities engaging in
p.000897: integrated care ac- tivities, as the Secretary determines appropriate.
p.000897: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
p.000897: tion, there are authorized to be appropriated $51,878,000 for each of fiscal years 2018 through 2022.
p.000897: SEC. 520L. ø290bb–43¿ ADULT SUICIDE PREVENTION.
p.000897: (a) GRANTS.—
p.000897: (1) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities described in
p.000897: paragraph (2) to imple- ment suicide prevention and intervention programs, for indi- viduals who are 25
p.000897: years of age or older, that are designed to raise awareness of suicide, establish referral processes, and im-
p.000897: prove care and outcomes for such individuals who are at risk of suicide.
p.000897: (2) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a
p.000897: community-based pri- mary care or behavioral health care setting, an emergency de- partment, a State mental health
p.000897: agency (or State health agen- cy with mental or behavioral health functions), public health agency, a
p.000897: territory of the United States, or an Indian tribe or tribal organization (as the terms ‘‘Indian tribe’’
p.000897: and ‘‘tribal or- ganization’’ are defined in section 4 of the Indian Self-Deter- mination and Education
p.000897: Assistance Act).
p.000897: (3) USE OF FUNDS.—The grants awarded under paragraph
p.000897: (1) shall be used to implement programs, in accordance with such paragraph, that include one or more of the
p.000897: following com- ponents:
p.000897:
p.000897:
p.000897:
p.000897:
p.000897: January 30, 2020
p.000897: (A) Screening for suicide risk, suicide intervention services, and services for referral for treatment for
p.000897: individ- uals at risk for suicide.
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
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p.000905: (1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in
p.000905: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.000905: payments received by the State under section 521.
p.000905: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
p.000905: amount in an amount greater than the amount the person is authorized to receive.
p.000905: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.000905: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.000905: for not more than 5 years, or both.
p.000905: SEC. 533. ø290cc–33¿ NONDISCRIMINATION.
p.000905: (a) IN GENERAL.—
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000905:
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p.000907: PUBLIC HEALTH SERVICE ACT
p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.000907: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.000907: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.000907: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.000907: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section
p.000907: 521 shall be considered to be programs and activities receiving Federal fi- nancial assistance.
p.000907: (2) PROHIBITION.—No person shall on the ground of sex or religion be excluded from participation in, be denied the
p.000907: bene- fits of, or be subjected to discrimination under, any program or activity funded in whole or in part with
p.000907: funds made available under section 521.
p.000907: (b) ENFORCEMENT.—
p.000907: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.000907: entity that has received a payment pursuant to section 521, has failed to comply with a provision of law
p.000907: referred to in subsection (a)(1), with subsection (a)(2), or with an applicable regulation (includ- ing one prescribed
p.000907: to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the State and shall re-
p.000907: quest the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days,
p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
p.000907: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.000907: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.000907: Rights Act of 1964, as may be applicable; or
p.000907: (C) take such other actions as may be authorized by
p.000907:
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p.000907: law.
p.000907: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
p.000917: each of fis- cal years 2019 through 2023.
p.000917: SEC. 547A. ø290ee–2a¿ PEER SUPPORT TECHNICAL ASSISTANCE CEN- TER.
p.000917: (a) ESTABLISHMENT.—The Secretary, acting through the Assist- ant Secretary, shall establish or operate a
p.000917: National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this
p.000917: section as the ‘‘Center’’).
p.000917: (b) FUNCTIONS.—The Center established under subsection (a) shall provide technical assistance and support
p.000917: to recovery commu- nity organizations and peer support networks, including such as- sistance and support
p.000917: related to—
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000917:
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p.000919: PUBLIC HEALTH SERVICE ACT
p.000919: Sec. 548
p.000919:
p.000919: (1) training on identifying—
p.000919: (A) signs of substance use disorder;
p.000919: (B) resources to assist individuals with a substance use disorder, or resources for families of an individual
p.000919: with a substance use disorder; and
...

p.000921: (c) COMPOSITION.—The working group convened under sub- section (b) shall include—
p.000921: (1) mental health consumers, including students and fam- ily members;
p.000921: (2) representatives of institutions of higher education;
p.000921: (3) representatives of national mental and behavioral health associations and associations of
p.000921: institutions of higher education;
p.000921: (4) representatives of health promotion and prevention or- ganizations at institutions of higher education;
p.000921: (5) representatives of mental health providers, including community mental health centers; and
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000923: PUBLIC HEALTH SERVICE ACT
p.000923: Sec. 550
p.000923:
p.000923: (6) representatives of private-sector and public-sector groups with experience in the development of
p.000923: effective public health education campaigns.
p.000923: (d) PLAN.—The working group under subsection (b) shall de- velop a plan that—
p.000923: (1) targets promotional and educational efforts to the age population of students at institutions of
p.000923: higher education and individuals who are employed in settings of institutions of higher education, including
p.000923: through the use of roundtables;
p.000923: (2) develops and proposes the implementation of research- based public health messages and activities;
p.000923: (3) provides support for local efforts to reduce stigma by using the National Health Information Center
p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
p.000923: for the pe- riod of fiscal years 2018 through 2022.
p.000923: SEC. 550. 15 ø290ee–5¿ NATIONAL RECOVERY HOUSING BEST PRAC- TICES.
p.000923: (a) BEST PRACTICES FOR OPERATING RECOVERY HOUSING.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities specified in paragraph
...

p.000925: (c) MINIMUM NUMBER OF CENTERS.—The Secretary shall allo- cate the amounts made available under subsection (j)
p.000925: such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a
p.000925: single State for any one period.
p.000925: (d) APPLICATION.—
p.000925: (1) ELIGIBLE ENTITY.—An entity is eligible for a grant under this section if the entity offers treatment and
p.000925: other serv- ices for individuals with a substance use disorder.
p.000925: (2) SUBMISSION OF APPLICATION.—In order to be eligible for a grant under subsection (a), an entity shall
p.000925: submit an applica- tion to the Secretary at such time and in such manner as the Secretary may require. Such
p.000925: application shall include—
p.000925: (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activi-
p.000925: ties described in subsection (g); and
p.000925: (B) such other information as the Secretary may re- quire.
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: PUBLIC HEALTH SERVICE ACT
p.000927: Sec. 552
p.000927:
p.000927: (e) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to eligible entities—
p.000927: (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national
p.000927: overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or
p.000927: (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education
p.000927: Assistance Act) with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate,
p.000927: as determined through appro- priate mechanisms determined by the Secretary in consultation with Indian Tribes.
p.000927: (f) PREFERENCE.—In awarding grants under subsection (a), the Secretary may give preference to eligible entities
p.000927: utilizing tech- nology-enabled collaborative learning and capacity building models, including such models as defined
p.000927: in section 2 of the Expanding Ca- pacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to
p.000927: conduct the activities described in this section.
p.000927: (g) CENTER ACTIVITIES.—Each Center shall, at a minimum, carry out the following activities directly,
p.000927: through referral, or through contractual arrangements, which may include carrying out such activities through
p.000927: technology-enabled collaborative learning and capacity building models described in subsection (f):
p.000927: (1) TREATMENT AND RECOVERY SERVICES.—Each Center shall—
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p.000927: (A) Ensure that intake, evaluations, and periodic pa- tient assessments meet the individualized clinical needs
p.000927: of patients, including by reviewing patient placement in treatment settings to support meaningful recovery.
...

p.000931: scribed in subparagraph (B);
p.000931: (D) coordinate the provision of the services of the sys- tem; and
p.000931: (E) establish an office whose functions are to serve as the location through which children are provided access to the
p.000931: system, to coordinate the provision of services of the system, and to provide information to the public
p.000931: regarding the system.
p.000931: (3) COLLABORATION OF LOCAL PUBLIC ENTITIES.—A funding agreement for a grant under section 561(a) is that,
p.000931: for pur- poses of the establishment and operation of a system of care under paragraph (1), the public
p.000931: entity involved will seek col- laboration among all public agencies that provide human serv- ices in the
p.000931: community in which the system is established, in- cluding but not limited to those providing mental
p.000931: health serv-
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000931:
p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
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p.000933:
p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
...

p.000935: for a grant under section 561(a) is that, with respect to a plan under sub- section (a) for a child,
p.000935: the multidisciplinary team required in sub- section (b) will—
p.000935: (1) in developing, carrying out, reviewing, and revising the plan consider any individualized education program
p.000935: in effect for the child pursuant to part B of the Individuals with Dis- abilities Education Act;
p.000935: (2) ensure that the plan is consistent with such individual- ized education program and provides for coordinating
p.000935: services under the plan with services under such program; and
p.000935: (3) ensure that the memorandum of understanding entered into under section 562(d)(3)(B) regarding such Act
p.000935: includes provisions regarding compliance with this subsection.
p.000935: (d) CONTENTS OF PLAN.—A funding agreement for a grant under section 561(a) is that the plan required in
p.000935: subsection (a) for a child will—
p.000935: (1) identify and state the needs of the child for the services available pursuant to section 562 through the system;
p.000935: (2) provide for each of such services that is appropriate to the circumstances of the child, including, except in the
p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
...

p.000937: outcomes of services provided by such systems, other
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
p.000937:
p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
p.000937: first appro- priated under subsection (c), and annually thereafter, submit to the Congress a report
p.000937: summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year and making such
p.000937: recommendations for administrative and legisla- tive initiatives with respect to this section as the Secretary de-
p.000937: termines to be appropriate.
p.000937: (d) DEFINITIONS.—For purposes of this part:
p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
p.000937: or adop- tive, as the case may be) and any foster parents of the child.
p.000937: (3) The term ‘‘funding agreement’’, with respect to a grant under section 561(a) to a public entity, means that
p.000937: the Sec- retary may make such a grant only if the public entity makes the agreement involved.
p.000937: (4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any child who has a
p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
...

p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000943: Sec. 595 PUBLIC HEALTH SERVICE ACT 944
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p.000943: in any form from any program supported in whole or in part with funds appropriated under this Act
p.000943: shall protect and pro- mote the rights of each resident of the facility, including the right to be free
p.000943: from physical or mental abuse, corporal punish- ment, and any restraints or involuntary seclusions imposed for purposes
p.000943: of discipline or convenience.
p.000943: (2) NONAPPLICABILITY.—Notwithstanding this part, a facil- ity that provides inpatient psychiatric treatment
p.000943: services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and (h)
p.000943: of section 1905 of the Social Secu- rity Act, shall comply with the requirements of part H.
p.000943: (3) APPLICABILITY OF MEDICAID PROVISIONS.—A non-med- ical, community-based facility for children and
p.000943: youth funded under the Medicaid program under title XIX of the Social Secu- rity Act shall continue to meet all
p.000943: existing requirements for participation in such program that are not affected by this part.
p.000943: (b) REQUIREMENTS.—
p.000943: (1) IN GENERAL.—Physical restraints and seclusion may only be imposed on a resident of a facility
p.000943: described in sub- section (a) if—
p.000943: (A) the restraints or seclusion are imposed only in emergency circumstances and only to ensure the imme-
p.000943: diate physical safety of the resident, a staff member, or others and less restrictive interventions have
p.000943: been deter- mined to be ineffective; and
p.000943: (B) the restraints or seclusion are imposed only by an individual trained and certified, by a State-recognized body (as
p.000943: defined in regulation promulgated by the Secretary) and pursuant to a process determined appropriate by
p.000943: the State and approved by the Secretary, in the prevention and use of physical restraint and seclusion,
p.000943: including the needs and behaviors of the population served, relationship building, alternatives to restraint and
p.000943: seclusion, de-esca- lation methods, avoiding power struggles, thresholds for restraints and seclusion, the
...

p.001001: 5 So in law. See section 2014(c)(2)(A)(i) of Public Law 103–43 (107 Stat. 216). The semicolon probably
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p.001003: PUBLIC HEALTH SERVICE ACT
p.001003: Sec. 723
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p.001003: as ‘‘designated graduates’’), the conditions referred to in such paragraph for a school for a 1-year period are
p.001003: as follows:
p.001003: (A) Not less than 50 percent of designated graduates of the school meet the criterion of either being
p.001003: in a resi- dency training program in primary health care, or being engaged in a practice in such care (having
p.001003: completed such a program).
p.001003: (B) Not less than 25 percent of the designated grad- uates of the school meet such criterion, and such
p.001003: percent- age is not less than 5 percentage points above the percent- age of such graduates meeting such
p.001003: criterion for the pre- ceding 1-year period.
p.001003: (C) In the case of schools of medicine or osteopathic medicine with student loans funds under section
p.001003: 721, the school involved is at or above the 75th percentile of such schools whose designated graduates meet
p.001003: such criterion.
p.001003: (3) DETERMINATIONS BY SECRETARY.—Not later than 90 days after the close of each 1-year period described
p.001003: in para- graph (1), the Secretary shall make a determination of whether the school involved has for such period
p.001003: complied with such paragraph and shall in writing inform the school of the deter- mination. Such determination shall
p.001003: be made only after consid- eration of the report submitted to the Secretary by the school under paragraph
p.001003: (6).
p.001003: (4) NONCOMPLIANCE BY SCHOOL.—
p.001003: (A)(i) Subject to subparagraph (C), each agreement under section 721 with a school of medicine or osteopathic
p.001003: medicine shall provide that, if the school fails to comply with paragraph (1) for a 1-year period under
p.001003: such para- graph, the school—
p.001003: (I) will pay to the Secretary the amount appli- cable under subparagraph (B) for the period; and
p.001003: (II) will pay such amount not later than 90 days after the school is informed under paragraph
p.001003: (3) of the determination of the Secretary regarding such period.
p.001003: (ii) Any amount that a school is required to pay under clause (i) may be paid from the student loan fund of
p.001003: the school under section 721.
p.001003: (B) For purposes of subparagraph (A), the amount ap- plicable for a school, subject to subparagraph (C), is—
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p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: January 30, 2020
p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
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p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001077: January 30, 2020
p.001077: SEC. 799. ø295o–1¿ GENERALLY APPLICABLE PROVISIONS.
p.001077: (a) AWARDING OF GRANTS AND CONTRACTS.—The Secretary shall ensure that grants and contracts under this title
p.001077: are awarded on a competitive basis, as appropriate, to carry out innovative dem- onstration projects or provide for
p.001077: strategic workforce supplemen- tation activities as needed to meet health workforce goals and in
p.001077: accordance with this title. Contracts may be entered into under this title with public or private entities as
p.001077: may be necessary.
p.001077: (b) ELIGIBLE ENTITIES.—Unless specifically required otherwise in this title, the Secretary shall accept
p.001077: applications for grants or contracts under this title from health professions schools, academic health centers,
p.001077: State or local governments, or other appropriate public or private nonprofit entities for funding and
p.001077: participation in health professions and nursing training activities. The Secretary may accept applications
p.001077: from for-profit private entities if deter- mined appropriate by the Secretary.
p.001077: (c) INFORMATION REQUIREMENTS.—
p.001077: (1) IN GENERAL.—Recipients of grants and contracts under this title shall meet information requirements as
p.001077: specified by the Secretary.
p.001077: (2) DATA COLLECTION.—The Secretary shall establish pro- cedures to ensure that, with respect to any data
p.001077: collection re- quired under this title, such data is collected in a manner that takes into account age, sex, race, and
p.001077: ethnicity.
p.001077: (3) USE OF FUNDS.—The Secretary shall establish proce- dures to permit the use of amounts appropriated
p.001077: under this title to be used for data collection purposes.
p.001077: (4) EVALUATIONS.—The Secretary shall establish proce- dures to ensure the annual evaluation of
p.001077: programs and projects operated by recipients of grants or contracts under this title. Such procedures shall
p.001077: ensure that continued funding for such programs and projects will be conditioned upon a dem- onstration
p.001077: that satisfactory progress has been made by the pro- gram or project in meeting the objectives of the program
p.001077: or project.
p.001077: (d) TRAINING PROGRAMS.—Training programs conducted with amounts received under this title shall meet
p.001077: applicable accredita- tion and quality standards.
p.001077: (e) DURATION OF ASSISTANCE.—
p.001077: (1) IN GENERAL.—Subject to paragraph (2), in the case of an award to an entity of a grant, cooperative
p.001077: agreement, or contract under this title, the period during which payments are made to the entity under the
p.001077: award may not exceed 5 years. The provision of payments under the award shall be subject to annual approval by the
p.001077: Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the
p.001077: payments. This paragraph may not be construed as limiting the number of awards under the program involved that
p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
...

p.001119: care community, and updating previous clinical preventive rec-
p.001119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001121: 1121
p.001121: PUBLIC HEALTH SERVICE ACT
p.001121: Sec. 915
p.001121:
p.001121: ommendations, to be published in the Guide to Clinical Preven- tive Services (referred to in this section as the
p.001121: ‘‘Guide’’), for in- dividuals and organizations delivering clinical services, includ- ing primary care
p.001121: professionals, health care systems, profes- sional societies, employers, community organizations, non-prof- it
p.001121: organizations, Congress and other policy-makers, govern- mental public health agencies, health care quality
p.001121: organiza- tions, and organizations developing national health objectives. Such recommendations shall consider
p.001121: clinical preventive best practice recommendations from the Agency for Healthcare Re- search and Quality, the
p.001121: National Institutes of Health, the Cen- ters for Disease Control and Prevention, the Institute of Medi- cine,
p.001121: specialty medical associations, patient groups, and sci- entific societies.
p.001121: (2) DUTIES.—The duties of the Task Force shall include—
p.001121: (A) the development of additional topic areas for new recommendations and interventions related to those
p.001121: topic areas, including those related to specific sub-populations and age groups;
p.001121: (B) at least once during every 5-year period, review interventions and update recommendations related to
p.001121: ex- isting topic areas, including new or improved techniques to assess the health effects of interventions;
p.001121: (C) improved integration with Federal Government health objectives and related target setting for
p.001121: health im- provement;
p.001121: (D) the enhanced dissemination of recommendations;
p.001121: (E) the provision of technical assistance to those health care professionals, agencies and
p.001121: organizations that request help in implementing the Guide recommendations; and
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p.001121: (F) the submission of yearly reports to Congress and related agencies identifying gaps in research, such as
p.001121: pre- ventive services that receive an insufficient evidence state- ment, and recommending priority areas that
p.001121: deserve fur- ther examination, including areas related to populations and age groups not adequately
p.001121: addressed by current rec- ommendations.
p.001121: (3) ROLE OF AGENCY.—The Agency shall provide ongoing administrative, research, and technical support for
p.001121: the oper- ations of the Task Force, including coordinating and sup- porting the dissemination of the
p.001121: recommendations of the Task Force, ensuring adequate staff resources, and assistance to those organizations
p.001121: requesting it for implementation of the Guide’s recommendations.
p.001121: (4) COORDINATION WITH COMMUNITY PREVENTIVE SERVICES TASK FORCE.—The Task Force shall take appropriate steps
p.001121: to coordinate its work with the Community Preventive Services Task Force and the Advisory Committee on
p.001121: Immunization Practices, including the examination of how each task force’s recommendations interact at the
p.001121: nexus of clinic and commu- nity.
p.001121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001121: Sec. 916 PUBLIC HEALTH SERVICE ACT 1122
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p.001135: data described in subsection (f)(1) that the pa- tient safety organization received from another entity, such
p.001135: former patient safety organization shall—
p.001135: (1) with the approval of the other entity and a patient safety organization, transfer such work product or
p.001135: data to such patient safety organization;
p.001135: (2) return such work product or data to the entity that submitted the work product or data; or
p.001135: (3) if returning such work product or data to such entity is not practicable, destroy such work product or
p.001135: data.
p.001135: SEC. 925. ø299b–24a¿ ACTIVITIES REGARDING WOMEN’S HEALTH.
p.001135: (a) ESTABLISHMENT.—There is established within the Office of the Director, an Office of Women’s Health
p.001135: and Gender-Based Re- search (referred to in this section as the ‘‘Office’’). The Office shall be headed by a
p.001135: director who shall be appointed by the Director of Healthcare and Research Quality.
p.001135: (b) PURPOSE.—The official designated under subsection (a) shall—
p.001135:
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p.001135: January 30, 2020
p.001135: (1) report to the Director on the current Agency level of ac- tivity regarding women’s health, across, where
p.001135: appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the
p.001135: development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes,
p.001135: delivery of health care services, quality of care, and access to health care;
p.001135: (2) establish short-range and long-range goals and objec- tives within the Agency for research important
p.001135: to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within
p.001135: the Agency that relate to health services and medical effectiveness research, for issues of particular concern to
p.001135: women;
p.001135: (3) identify projects in women’s health that should be con- ducted or supported by the Agency;
p.001135: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.001135: profes- sionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
p.001135: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.001135: Health (established under section 229(b)(4)).
p.001135: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001135: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
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p.001147: (A) to develop, update, and produce patient decision aids for preference sensitive care to assist health care
p.001147: pro- viders in educating patients, caregivers, and authorized representatives concerning the relative safety,
p.001147: relative ef- fectiveness (including possible health outcomes and impact on functional status), and relative cost
p.001147: of treatment or, where appropriate, palliative care options;
p.001147: (B) to test such materials to ensure such materials are balanced and evidence based in aiding health care pro-
p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and
p.001147: (C) to educate providers on the use of such materials, including through academic curricula.
p.001147: (2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient decision aids developed and produced pursuant to a
p.001147: grant or contract under paragraph (1)—
p.001147: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed
p.001147: decision- making with health care providers;
p.001147: (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and man- ner
p.001147: that is age-appropriate and can be adapted for pa- tients, caregivers, and authorized representatives
p.001147: from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and
p.001147: diverse levels of health literacy;
p.001147: (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option
p.001147: over an- other; and
p.001147: (D) shall address health care decisions across the age span, including those affecting vulnerable
p.001147: populations in- cluding children.
p.001147: (3) DISTRIBUTION.—The Director shall ensure that patient decision aids produced with grants or contracts under
p.001147: this sec- tion are available to the public.
p.001147: (4) NONDUPLICATION OF EFFORTS.—The Director shall en- sure that the activities under this section of
p.001147: the Agency and other agencies, including the Centers for Disease Control and
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001149: PUBLIC HEALTH SERVICE ACT
p.001149: Sec. 937
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p.001149: January 30, 2020
p.001149: Prevention and the National Institutes of Health, are free of unnecessary duplication of effort.
p.001149: (e) GRANTS TO SUPPORT SHARED DECISIONMAKING IMPLEMEN-
p.001149: TATION.—
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p.001201: human trafficking victims identified and served by grantees in a manner that, at a minimum, prevents
p.001201: disclosure of indi- vidually identifiable information consistent with all appli- cable privacy laws and
p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001203: PUBLIC HEALTH SERVICE ACT
p.001203: Sec. 1261
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p.001203: (4) health care and social service provider profiles.
p.001203: (e) DATA COLLECTION AND REPORTING.—
p.001203: (1) IN GENERAL.—The Secretary shall collect data and re- port on the following:
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p.001217: by which its costs for any of its fiscal years exceed 115 per centum of its in- come for such fiscal year, and
p.001217: (D) make arrangements with physicians or other health professionals, health care institu- tions, or any
p.001217: combination of such individuals or institutions to
p.001217: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001217:
p.001217:
p.001217: January 30, 2020
p.001217:
p.001217: assume all or part of the financial risk on a prospective basis for the provision of basic health
p.001217: services by the physicians or other health professionals or through the institutions;
p.001217: (3)(A) enroll persons who are broadly representative of the various age, social, and income groups within the
p.001217: area it serves, except that in the case of a health maintenance organi- zation which has a medically underserved
p.001217: population located (in whole or in part) in the area it serves, not more than 75 per centum of the
p.001217: members of that organization may be en- rolled from the medically underserved population unless the area
p.001217: in which such population resides is also a rural area (as designated by the Secretary), and (B) carry
p.001217: out enrollment of members who are entitled to medical assistance under a State plan approved under title XIX of the
p.001217: Social Security Act in ac- cordance with procedures approved under regulations promul- gated by the Secretary;
p.001217: (4) not expel or refuse to re-enroll any member because of his health status or his requirements for health services;
p.001217: (5) be organized in such a manner that provides meaning- ful procedures for hearing and resolving grievances
p.001217: between the health maintenance organization (including the medical group or groups and other health
p.001217: delivery entities providing health services for the organization) and the members of the organization;
p.001217: (6) have organizational arrangements, established in ac- cordance with regulations of the Secretary, for
p.001217: an ongoing quality assurance program for its health services which pro- gram (A) stresses health outcomes, and
p.001217: (B) provides review by physicians and other health professionals of the process fol- lowed in the provision of
p.001217: health services;
p.001217: (7) adopt at least one of the following arrangements to pro- tect its members from incurring liability for
p.001217: payment of any fees which are the legal obligation of such organization—
...

p.001219: (4) The term ‘‘medical group’’ means a partnership, association, or other group—
p.001219: (A) which is composed of health professionals licensed to practice medicine or osteopathy and of such
p.001219: other licensed health professionals (including dentists, optometrists, podia- trists, and psychologists) as
p.001219: are necessary for the provision of health services for which the group is responsible;
p.001219: (B) a majority of the members of which are licensed to practice medicine or osteopathy; and
p.001219: (C) the members of which (i) as their principal professional activity engage in the coordinated practice of
p.001219: their profession and as a group responsibility have substantial responsibility for the delivery of health
p.001219: services to members of a health maintenance organization, except that this clause does not apply before the
p.001219: end of the forty-eight month period beginning after the month in which the health maintenance oranization 1 becomes a
p.001219: qualified health maintenance organization as de- fined in section 1310(d), or as authorized by the
p.001219: Secretary in accordance with regulations that take into consideration the usual circumstances of the group;
p.001219: (ii) pool their income from practice as members of the group and distribute it among themselves
p.001219: according to a prearranged salary or drawing ac- count or other similar plan unrelated to the provision
p.001219: of spe- cific health services; (iii) share medical and other records and substantial portions of major
p.001219: equipment and of professional, technical, and administrative staff; (iv) arrange for and encour- age continuing
p.001219: education in the field of clinical medicine and related areas for the members of the group; and (v)
p.001219: establish an arrangement whereby a member’s enrollment status is not
p.001219:
p.001219:
p.001219:
p.001219: January 30, 2020
p.001219: 1 So in law. Probably should be ‘‘organization’’.
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001219:
p.001219:
p.001219:
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p.001219:
p.001219:
p.001219: C:\XML\SSA-MERGED.XML
p.001219:
p.001219:
p.001221: 1221
p.001221: PUBLIC HEALTH SERVICE ACT
p.001221: Sec. 1302
p.001221:
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p.001221:
p.001221:
p.001221:
p.001221: January 30, 2020
p.001221: known to the health professional who provides health services to the member.
p.001221: (5) The term ‘‘individual practice association’’ means a partner- ship, corporation, association, or other legal
p.001221: entity which has en- tered into a services arrangement (or arrangements) with persons who are licensed to
...

p.001231: C:\XML\PHSA.BEL HOUSEP
p.001231:
p.001231:
p.001231: C:\XML\SSA-MERGED.XML
p.001231:
p.001231: Sec. 1311 PUBLIC HEALTH SERVICE ACT 1232
p.001231: has failed to comply with paragraph (1) or (2) of subsection (b), the Secretary shall terminate payments to such
p.001231: State under sections 317, 318, and 1002 and notify the Governor of such State that fur- ther payments under such
p.001231: sections will not be made to the State until the Secretary is satisfied that there will no longer be
p.001231: any such failure to comply.
p.001231:
p.001231:
p.001231:
p.001231:
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p.001231:
p.001231: January 30, 2020
p.001231:
p.001231: RESTRICTIVE STATE LAWS AND PRACTICES
p.001231: SEC. 1311. ø300e–10¿ (a) In the case of any entity—
p.001231: (1) which cannot do business as a health maintenance or- ganization in a State in which it proposes to furnish
p.001231: basic and supplemental health services because that State by law, regu- lation, or otherwise—
p.001231: (A) requires as a condition to doing business in that State that a medical society approve the
p.001231: furnishing of services by the entity,
p.001231: (B) requires that physicians constitute all or a percent- age of its governing body,
p.001231: (C) requires that all physicians or a percentage of phy- sicians in the locale participate or be permitted to partici-
p.001231: pate in the provision of services for the entity,
p.001231: (D) requires that the entity meet requirements for in- surers of health care services doing business in that State
p.001231: respecting initial capitalization and establishment of finan- cial reserves against insolvency, or
p.001231: (E) imposes requirements which would prohibit the entity from complying with the requirements of this
p.001231: title, and
p.001231: (2) for which a grant, contract, loan, or loan guarantee was made under this title or which is a qualified
p.001231: health mainte- nance organization for purposes of section 1310 (relating to em- ployees’ health benefits plans),
p.001231: such requirements shall not apply to that entity so as to prevent it from operating as a health
p.001231: maintenance organization in accord- ance with section 1301.
p.001231: (b) No State may establish or enforce any law which prevents a health maintenance organization for which
p.001231: a grant, contract, loan, or loan guarantee was made under this title or which is a qualified health
p.001231: maintenance organization for purposes of section 1310 (relating to employees’ health benefits plans), from
p.001231: soliciting members through advertising its services, charges, or other non- professional aspects of its
p.001231: operation. This subsection does not au- thorize any advertising which identifies, refers to, or makes any
p.001231: qualitative judgment concerning, any health professional who pro- vides services for a health maintenance
p.001231: organization.
...

p.001261: C:\XML\PHSA.BEL HOUSEP
p.001261:
p.001261:
p.001261: C:\XML\SSA-MERGED.XML
p.001261:
p.001261: Sec. 1640 PUBLIC HEALTH SERVICE ACT 1262
p.001261:
p.001261: by such person with the Secretary and the Secretary has dismissed such complaint or the Attorney General has not
p.001261: brought a civil ac- tion for compliance with such assurance within six months after the date on which the
p.001261: complaint was filed with the Secretary.
p.001261: PART D—AREA HEALTH SERVICES DEVELOPMENT FUNDS
p.001261: DEVELOPMENT GRANTS FOR AREA HEALTH SERVICES DEVELOPMENT FUNDS
p.001261: SEC. 1640. ø300t¿ (a) The Secretary shall make in each fiscal year a grant to each health systems agency—
p.001261: (1) with which there is in effect a designation agreement under section 1515(c),
p.001261: (2) which has in effect an HSP and AIP reviewed by the Statewide Health Coordinating Council, and
p.001261: (3) which, as determined under the review made under section 1535(c), is organized and operated in the
p.001261: manner pre- scribed by section 1512(b) and is performing its functions under section 1513 in a
p.001261: manner satisfactory to the Secretary,
p.001261: to enable the agency to establish and maintain an Area Health Services Development Fund from which it
p.001261: may make grants and enter into contracts in accordance with section 1513(c)(3).
p.001261: (b)(1) Except as provided in paragraph (2), the amount of any grant under subsection (a) shall be
p.001261: determined by the Secretary after taking into consideration the population of the health service area for which
p.001261: the health systems agency is designated, the aver- age family income of the area, and the supply of health
p.001261: services in the area.
p.001261: (2) The amount of any grant under subsection (a) to a health systems agency for any fiscal year may
p.001261: not exceed the product of
p.001261: $1 and the population of the health service area for which such agency is designated.
p.001261: (c) No grant may be made under subsection (a) unless an appli- cation therefor has been submitted to, and
p.001261: approved by, the Sec- retary. Such an application shall be submitted in such form and manner and contain
p.001261: such information as the Secretary may re- quire.
p.001261: (d) For the purpose of making payments pursuant to grants under subsection (a), there are authorized
p.001261: to be appropriated
p.001261: $25,000,000 for the fiscal year ending June 30, 1975, $75,000,000 for the fiscal year ending June 30, 1976,
p.001261: $120,000,000 each for the fiscal years ending September 30, 1977, and September 30, 1978,
p.001261: $20,000,000 for the fiscal year ending September 30, 1981, and
p.001261: $30,000,000 for the fiscal year ending September 30, 1982.
p.001261: PART E—PROGRAM TO ASSIST AND ENCOURAGE THE VOLUNTARY DISCONTINUANCE OF UNNEEDED HOSPITAL SERVICES
p.001261: AND THE CONVERSION OF UNNEEDED HOSPITAL SERVICES TO OTHER HEALTH SERVICES NEEDED BY THE
p.001261: COMMUNITY
p.001261:
p.001261:
p.001261:
p.001261:
p.001261:
p.001261: January 30, 2020
p.001261: ESTABLISHMENT OF PROGRAM
p.001261: SEC. 1641. ø300t–11¿ The Secretary shall, by April 1, 1980, es- tablish a program under which—
p.001261: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001261:
p.001261:
p.001261:
p.001261:
p.001261:
p.001261:
...

p.001293: provided under section 1905.
p.001293: (c) Each State, and each entity which has received funds from an allotment made to a State under this part,
p.001293: shall make appro- priate books, documents, papers, and records available to the Sec- retary or the
p.001293: Comptroller General of the United States, or any of their duly authorized representatives, for
p.001293: examination, copying, or mechanical reproduction on or off the premises of the appropriate entity upon a
p.001293: reasonable request therefor.
p.001293: (d)(1) In conducting any investigation in a State, the Secretary or the Comptroller General of the United States
p.001293: may not make a request for any information not readily available to such State or an entity which has
p.001293: received funds from an allotment made to the State under this part or make an unreasonable request for infor-
p.001293: mation to be compiled, collected, or transmitted in any form not readily available.
p.001293: (2) Paragraph (1) does not apply to the collection, compilation, or transmittal of data in the course of a judicial
p.001293: proceeding.
p.001293:
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p.001293:
p.001293: January 30, 2020
p.001293: NONDISCRIMINATION
p.001293: SEC. 1908. ø300w–7¿ (a)(1) For the purpose of applying the prohibitions against discrimination on the
p.001293: basis of age under the Age Discrimination Act of 1975, on the basis of handicap under sec- tion 504 of the
p.001293: Rehabilitation Act of 1973, on the basis of sex under title IX of the Education Amendments of 1972, or on the
p.001293: basis of race, color, or national origin under title VI of the Civil Rights Act of 1964, programs and activities
p.001293: funded in whole or in part with funds made available under this part are considered to be pro- grams
p.001293: and activities receiving Federal financial assistance.
p.001293: (2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits
p.001293: of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds
p.001293: made available under this part.
p.001293: (b) Whenever the Secretary finds that a State, or an entity that has received a payment from an
p.001293: allotment to a State under section 1902, has failed to comply with a provision of law referred to in subsection
p.001293: (a)(1), with subsection (a)(2), or with an applicable regulation (including one prescribed to carry out subsection
p.001293: (a)(2)), the Secretary shall notify the chief executive officer of the State and shall request him to secure
p.001293: compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer
p.001293: fails or refuses to secure compliance, the Secretary may—
p.001293: (1) refer the matter to the Attorney General with a rec- ommendation that an appropriate civil action be
p.001293: instituted,
p.001293: (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964, the Age
p.001293: Discrimination Act of 1975, or section 504 of the Rehabilitation Act of 1973, as may be applicable, or
p.001293: (3) take such other action as may be provided by law.
p.001293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001293:
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p.001295: 1295
p.001295: PUBLIC HEALTH SERVICE ACT
p.001295: Sec. 1910
p.001295:
p.001295: (c) When a matter is referred to the Attorney General pursuant to subsection (b)(1), or whenever he has reason
p.001295: to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of
p.001295: law referred to in subsection (a)(1) or in violation of subsection (a)(2), the Attorney General may bring a
p.001295: civil action in any appropriate district court of the United States for such relief as may be appropriate, including
p.001295: injunctive relief.
p.001295: CRIMINAL PENALTY FOR FALSE STATEMENTS
p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
p.001295: fact in con- nection with the furnishing of items or services for which pay- ment may be made by a State from funds
p.001295: allotted to the State under this part, or
p.001295: (2) having knowledge of the occurrence of any event affect- ing his initial or continued right to any such payment
p.001295: conceals or fails to disclose such event with an intent fraudulently to se- cure such payment either in a greater
...

p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
p.001297: (I) a description of the activities intended to reduce hospitalizations and hospital stays using the block
p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001297:
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p.001303: (4) DETERMINATION OF TERM ‘‘X’’.—For purposes of para- graph (1), the term ‘‘X’’ means the product of—
p.001303: (A) an amount equal to the product of—
p.001303: (i) the term ‘‘P’’, as determined for the State in- volved under paragraph (5); and
p.001303: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001303:
p.001303:
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p.001303:
p.001303:
p.001305: 1305
p.001305: PUBLIC HEALTH SERVICE ACT
p.001305: Sec. 1918
p.001305:
p.001305: (ii) the factor determined under paragraph (8) for the State; and
p.001305: (B) the greater of—
p.001305: (i) 0.4; and
p.001305: (ii) an amount equal to an amount determined for the State in accordance with the following formula:
p.001305:
p.001305: R%
p.001305: 1¥.35 ( ) P%
p.001305:
p.001305:
p.001305:
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p.001305:
p.001305: January 30, 2020
p.001305: (5) DETERMINATION OF TERM ‘‘P’’.—
p.001305: (A) For purposes of paragraph (4), the term ‘‘P’’ means the sum of—
p.001305: (i) an amount equal to the product of 0.107 and the number of individuals in the State who are be-
p.001305: tween 18 and 24 years of age (inclusive);
p.001305: (ii) an amount equal to the product of 0.166 and the number of individuals in the State who are be-
p.001305: tween 25 and 44 years of age (inclusive);
p.001305: (iii) an amount equal to the product of 0.099 and the number of individuals in the State who are be-
p.001305: tween 45 and 64 years of age (inclusive); and
p.001305: (iv) an amount equal to the product of 0.082 and the number of individuals in the State who are 65
p.001305: years of age or older.
p.001305: (B) With respect to data on population that is nec- essary for purposes of making a determination under sub-
p.001305: paragraph (A), the Secretary shall use the most recent data that is available from the Secretary of Commerce
p.001305: pur- suant to the decennial census and pursuant to reasonable estimates by such Secretary of changes
p.001305: occurring in the data in the ensuing period.
p.001305: (6) DETERMINATION OF TERM ‘‘R%’’.—
p.001305: (A) For purposes of paragraph (4), the term ‘‘R%’’, ex- cept as provided in subparagraph (D), means the
p.001305: percent- age constituted by the ratio of the amount determined under subparagraph (B) for the State
p.001305: involved to the amount determined under subparagraph (C).
p.001305: (B) The amount determined under this subparagraph for the State involved is the quotient of—
p.001305: (i) the most recent 3-year arithmetic mean of the total taxable resources of the State, as determined
p.001305: by the Secretary of the Treasury; divided by
p.001305: (ii) the factor determined under paragraph (8) for the State.
p.001305: (C) The amount determined under this subparagraph is the sum of the respective amounts determined for
p.001305: the States under subparagraph (B) (including the District of Columbia).
p.001305: (D)(i) In the case of the District of Columbia, for pur- poses of paragraph (4), the term ‘‘R%’’ means the
p.001305: percent- age constituted by the ratio of the amount determined
p.001305: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001305:
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p.001305:
p.001305: Sec. 1918 PUBLIC HEALTH SERVICE ACT 1306
p.001305:
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p.001305:
p.001305: under clause (ii) for such District to the amount deter- mined under clause (iii).
p.001305: (ii) The amount determined under this clause for the District of Columbia is the quotient of—
p.001305: (I) the most recent 3-year arithmetic mean of total personal income in such District, as determined by the Secretary of
p.001305: Commerce; divided by
p.001305: (II) the factor determined under paragraph (8) for the District.
p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
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p.001307:
p.001307: SEC. 1920. ø300x–9¿ FUNDING.
p.001307: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, and subpart III and
p.001307: section 505(c) with respect to mental health, there are authorized to be appropriated
p.001307: $532,571,000 for each of fiscal years 2018 through 2022.
p.001307: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, DATA COLLEC-
p.001307: TION, AND PROGRAM EVALUATION.—
p.001307: (1) IN GENERAL.—For the purpose of carrying out section 1948(a) with respect to mental health and the
p.001307: purposes speci- fied in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts
p.001307: appropriated under subsection (a) for a fiscal year.
p.001307: (2) DATA COLLECTION.—The purpose specified in this para- graph is carrying out sections 505(c) and 1971 with
p.001307: respect to mental health.
p.001307: (3) PROGRAM EVALUATION.—The purpose specified in this paragraph is the conduct of evaluations of
p.001307: prevention and treatment programs and services with respect to mental health to determine methods for improving
p.001307: the availability and qual- ity of such programs and services.
p.001307: (c) EARLY SERIOUS MENTAL ILLNESS.—
p.001307: (1) IN GENERAL.—Except as provided in paragraph (2), a State shall expend not less than 10 percent of the
p.001307: amount the State receives for carrying out this section for each fiscal year to support evidence-based programs
p.001307: that address the needs of individuals with early serious mental illness, including psy- chotic disorders,
p.001307: regardless of the age of the individual at onset.
p.001307: (2) STATE FLEXIBILITY.—In lieu of expending 10 percent of the amount the State receives under this section for
p.001307: a fiscal year as required under paragraph (1), a State may elect to ex- pend not less than 20 percent of such
p.001307: amount by the end of such succeeding fiscal year.
p.001307:
p.001307: Subpart II—Block Grants for Prevention and Treatment of Substance Abuse
p.001307:
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p.001307: January 30, 2020
p.001307: SEC. 1921. ø300x–21¿ FORMULA GRANTS TO STATES.
p.001307: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Center for
p.001307: Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in
p.001307: accordance with section 1933. The Sec- retary shall make a grant to the State of the allotment made for the
p.001307: State for the fiscal year if the State submits to the Secretary an application in accordance with section
p.001307: 1932.
p.001307: (b) AUTHORIZED ACTIVITIES.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001307: 1931, the State in- volved will expend the grant only for the purpose of carrying out the plan developed
p.001307: in accordance with section 1932(b) and for plan- ning, carrying out, and evaluating activities to prevent and
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p.001307:
p.001309: 1309
p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
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p.001313: January 30, 2020
p.001313:
p.001313: (6) Such loans are made only to nonprofit private entities agreeing that, in the operation of the program
p.001313: established pur- suant to the loan—
p.001313: (A) the use of alcohol or any illegal drug in the hous- ing provided by the program will be prohibited;
p.001313: (B) any resident of the housing who violates such pro- hibition will be expelled from the housing;
p.001313: (C) the costs of the housing, including fees for rent and utilities, will be paid by the residents of the
p.001313: housing; and
p.001313: (D) the residents of the housing will, through a major- ity vote of the residents, otherwise establish policies
p.001313: gov- erning residence in the housing, including the manner in which applications for residence in the
p.001313: housing are ap- proved.
p.001313: (b) ISSUANCE BY SECRETARY OF GUIDELINES.—The Secretary shall ensure that there are in effect
p.001313: guidelines under this subpart for the operation of programs described in subsection (a).
p.001313: (c) APPLICABILITY TO TERRITORIES.—The requirements estab- lished in subsection (a) shall not apply to any
p.001313: territory of the United States other than the Commonwealth of Puerto Rico.
p.001313: SEC. 1926. ø300x–26¿ SALE OF TOBACCO PRODUCTS TO INDIVIDUALS UNDER AGE OF 21.
p.001313: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved will—
p.001313: (1) annually conduct random, unannounced inspections to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21; and
p.001313: (2) annually submit to the Secretary a report describing—
p.001313: (A) the activities carried out by the State to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21;
p.001313: (B) the extent of success the State has achieved in en- suring that retailers do not sell tobacco products to
p.001313: indi- viduals under the age of 21; and
p.001313: (C) the strategies to be utilized by the State to ensure that retailers do not sell tobacco products to
p.001313: individuals under the age of 21 during the fiscal year for which the grant is sought.
p.001313: (b) NONCOMPLIANCE OF STATE.—
p.001313: (1) IN GENERAL.—Before making a grant under section 1921 to a State, the Secretary shall make a
p.001313: determination of whether the State has maintained compliance with subsection (a). If, after notice to the State
p.001313: and an opportunity for a hear- ing, the Secretary determines that the State is not in compli- ance with
p.001313: such subsections, the Secretary shall reduce the amount of the allotment under such section for the
p.001313: State for the fiscal year involved by an amount up to 10 percent of the amount determined under section
p.001313: 1933 for the State for the applicable fiscal year.
p.001313: (2) LIMITATION.—
p.001313: (A) IN GENERAL.—A State shall not have funds with- held pursuant to paragraph (1) if such State for which the
p.001313: Secretary has made a determination of noncompliance under such paragraph—
p.001313: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001315: 1315
p.001315: PUBLIC HEALTH SERVICE ACT
p.001315: Sec. 1926
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p.001315: January 30, 2020
p.001315: (i) certifies to the Secretary by May 1 of the fiscal year for which the funds are appropriated, consistent with
p.001315: subparagraph (B), that the State will commit ad- ditional State funds, in accordance with paragraph (1), to ensure that
p.001315: retailers do not sell tobacco products to individuals under 21 years of age;
p.001315: (ii) agrees to comply with a negotiated agreement for a corrective action plan that is approved by the
p.001315: Secretary and carried out in accordance with guide- lines issued by the Secretary; or
p.001315: (iii) is a territory that receives less than
p.001315: $1,000,000 for a fiscal year under section 1921.
p.001315: (B) CERTIFICATION.—
p.001315: (i) IN GENERAL.—The amount of funds to be com- mitted by a State pursuant to subparagraph (A)(i) shall
p.001315: be equal to 1 percent of such State’s substance abuse allocation determined under section 1933 for each
p.001315: percentage point by which the State misses the retailer compliance rate goal established by the Sec-
p.001315: retary.
p.001315: (ii) STATE EXPENDITURES.—For a fiscal year in which a State commits funds as described in clause (i), such State
p.001315: shall maintain State expenditures for to- bacco prevention programs and for compliance activi- ties at a
p.001315: level that is not less than the level of such expenditures maintained by the State for the pre- ceding
p.001315: fiscal year, plus the additional funds for tobacco compliance activities required under clause (i). The State
p.001315: shall submit a report to the Secretary on all State obligations of funds for such fiscal year and all
p.001315: State expenditures for the preceding fiscal year for to- bacco prevention and compliance activities by program activity
p.001315: by July 31 of such fiscal year.
p.001315: (iii) DISCRETION.—The Secretary shall exercise discretion in enforcing the timing of the State obliga-
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p.001315: Further Con- solidated Appropriations Act, 2020, the Secretary shall update regulations under part 96 of title
p.001315: 45, Code of Federal Regula- tions or guidance on the retailer compliance rate goal under subsection (b),
p.001315: the use of funds provided under section 1921 for purposes of meeting the requirements of this section, and re-
p.001315: porting requirements under subsection (a)(2).
p.001315: (3) COORDINATION.—The Secretary shall ensure the Assist- ant Secretary for Mental Health and Substance Use
p.001315: coordi- nates, as appropriate, with the Commissioner of Food and Drugs to ensure that the technical
p.001315: assistance provided to States under subsection (e) is consistent with applicable regu- lations for
p.001315: retailers issued under part 1140 of title 21, Code of Federal Regulations.
p.001315: (d) TRANSITIONAL GRANTS.—
p.001315: (1) IN GENERAL.—The Secretary shall award grants under this subsection to each State that receives
p.001315: funding under sec- tion 1921 to ensure compliance of each such State with this section.
p.001315: (2) USE OF FUNDS.—A State receiving a grant under this subsection—
p.001315: (A) shall use amounts received under such grant for activities to plan for or ensure compliance in the
p.001315: State with subsection (a); and
p.001315: (B) in the case of a State for which the Secretary has made a determination under subsection (b) that the State
p.001315: is prepared to meet, or has met, the requirements of sub- section (a), may use such funds for tobacco
p.001315: cessation activi- ties, strategies to prevent the use of tobacco products by individuals under the age of
p.001315: 21, or allowable uses under section 1921.
p.001315: (3) SUPPLEMENT NOT SUPPLANT.—Grants under this sub- section shall be used to supplement and not supplant
p.001315: other Federal, State, and local public funds provided for activities under paragraph (2).
p.001315: (4) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there are authorized to be
p.001315: appropriated
p.001315: $18,580,790 for each of fiscal years 2020 through 2024.
p.001315: (5) SUNSET.—This subsection shall have no force or effect after September 30, 2024.
p.001315: (e) TECHNICAL ASSISTANCE.—The Secretary shall provide tech- nical assistance to States related to the
p.001315: activities required under this section.
p.001315: SEC. 1927. ø300x–27¿ TREATMENT SERVICES FOR PREGNANT WOMEN.
p.001315: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved—
p.001315: (1) will ensure that each pregnant woman in the State who seeks or is referred for and would benefit from such
p.001315: services is given preference in admissions to treatment facilities receiv- ing funds pursuant to the grant; and
p.001315: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: 1317
p.001317: PUBLIC HEALTH SERVICE ACT
p.001317: Sec. 1928
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p.001323: January 30, 2020
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p.001323: and in the same manner as the formula applies for pur- poses of section 1918(a), except that, in the
p.001323: application of such formula for purposes of this subsection, the modifica- tions described in subparagraph (B) shall
p.001323: apply.
p.001323: (B) For purposes of subparagraph (A), the modifica- tions described in this subparagraph are as follows:
p.001323: (i) The amount specified in paragraph (2)(A) of section 1918(a) is deemed to be the amount appro-
p.001323: priated under section 1935(a) for allotments under sec- tion 1921 for the fiscal year involved.
p.001323: (ii) The term ‘‘P’’ is deemed to have the meaning given in paragraph (2) of this subsection.
p.001323: Section 1918(a)(5)(B) applies to the data used in determining such term for the States.
p.001323: (iii) The factor determined under paragraph (8) of section 1918(a) is deemed to have the purpose of re-
p.001323: flecting the differences that exist between the State involved and other States in the costs of providing au-
p.001323: thorized services.
p.001323: (2) DETERMINATION OF TERM ‘‘P’’.—For purposes of this subsection, the term ‘‘P’’ means the percentage
p.001323: that is the arithmetic mean of the percentage determined under subpara- graph (A) and the percentage determined under
p.001323: subparagraph (B), as follows:
p.001323: (A) The percentage constituted by the ratio of—
p.001323: (i) an amount equal to the sum of the total num- ber of individuals who reside in the State involved and are
p.001323: between 18 and 24 years of age (inclusive) and the number of individuals in the State who reside in ur-
p.001323: banized areas of the State and are between such years of age; to
p.001323: (ii) an amount equal to the total of the respective sums determined for the States under clause (i).
p.001323: (B) The percentage constituted by the ratio of—
p.001323: (i) the total number of individuals in the State who are between 25 and 64 years of age (inclusive); to
p.001323: (ii) an amount equal to the sum of the respective amounts determined for the States under clause (i).
p.001323: (b) MINIMUM ALLOTMENTS FOR STATES.—
p.001323: (1) IN GENERAL.—With respect to fiscal year 2000, and each subsequent fiscal year, the amount of the
p.001323: allotment of a State under section 1921 shall not be less than the amount the State received under such section
p.001323: for the previous fiscal year increased by an amount equal to 30.65 percent of the percent- age by which the
p.001323: aggregate amount allotted to all States for such fiscal year exceeds the aggregate amount allotted to
p.001323: all States for the previous fiscal year.
p.001323: (2) LIMITATIONS.—
p.001323: (A) IN GENERAL.—Except as provided in subparagraph (B), a State shall not receive an allotment under section
p.001323: 1921 for a fiscal year in an amount that is less than an amount equal to 0.375 percent of the amount
p.001323: appropriated under section 1935(a) for such fiscal year.
p.001323: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001325: 1325
p.001325: PUBLIC HEALTH SERVICE ACT
p.001325: Sec. 1933
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p.001325: January 30, 2020
p.001325: (B) EXCEPTION.—In applying subparagraph (A), the Secretary shall ensure that no State receives an increase
p.001325: in its allotment under section 1921 for a fiscal year (as compared to the amount allotted to the State
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p.001331: involved in accord- ance with the agreements required under the program. Any such investigation shall be
p.001331: conducted within the State by qualified investigators.
p.001331: SEC. 1946. ø300x–56¿ PROHIBITIONS REGARDING RECEIPT OF FUNDS.
p.001331: (a) ESTABLISHMENT.—
p.001331: (1) CERTAIN FALSE STATEMENTS AND REPRESENTATIONS.—A person shall not knowingly and willfully make or cause
p.001331: to be made any false statement or representation of a material fact in connection with the furnishing of
p.001331: items or services for which payments may be made by a State from a grant made to the State under section
p.001331: 1911 or 1921.
p.001331: (2) CONCEALING OR FAILING TO DISCLOSE CERTAIN EVENTS.—A person with knowledge of the
p.001331: occurrence of any event affecting the initial or continued right of the person to receive any payments from
p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
p.001331: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.001331: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.001331: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.001331: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001331: Sec. 1948 PUBLIC HEALTH SERVICE ACT 1332
p.001331:
p.001331: whole or in part with funds made available under section 1911 or 1921.
p.001331: (b) ENFORCEMENT.—
p.001331: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
p.001331: State and shall request the chief executive officer to secure compliance. If within a reasonable period of
p.001331: time, not to exceed
p.001331: 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
p.001331: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.001331: insti- tuted;
p.001331: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.001331: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.001331: Rights Act of 1964, as may be applicable; or
p.001331: (C) take such other actions as may be authorized by
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p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331: January 30, 2020
p.001331: law.
p.001331: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.001331: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.001331: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.001331: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.001331: the United States for such relief as may be appropriate, including injunc- tive relief.
p.001331: SEC. 1948. ø300x–58¿ TECHNICAL ASSISTANCE AND PROVISION OF SUP- PLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001331: (a) TECHNICAL ASSISTANCE.—The Secretary shall, without charge to a State receiving a grant under section 1911
p.001331: or 1921, pro- vide to the State (or to any public or nonprofit private entity within the State) technical assistance
p.001331: with respect to the planning, devel- opment, and operation of any program or service carried out pursu- ant to the
...

p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
p.001341:
p.001341:
p.001341:
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p.001341:
p.001341:
p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
...

p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
p.001343:
p.001343:
p.001343:
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p.001343:
p.001343:
p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
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p.001371: residential and custodial care and service expenses, special equipment, related trav- el expenses, and facilities
p.001371: determined to be reasonably nec- essary.
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 8 Effective October 1, 1988.
p.001371:
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
p.001371:
p.001371:
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p.001373: 1373
p.001373: PUBLIC HEALTH SERVICE ACT
p.001373: Sec. 2115
p.001373:
p.001373: (B) Subject to section 2116(a)(2), actual unreimbursable ex- penses incurred before the date of the judgment awarding
p.001373: such expenses which—
p.001373: (i) resulted from the vaccine-related injury for which the petitioner seeks compensation,
p.001373: (ii) were incurred by or on behalf of the person who suffered such injury, and
p.001373: (iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special
p.001373: edu- cation, vocational training and placement, case manage- ment services, counseling, emotional or behavioral
p.001373: therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and
p.001373: facilities deter- mined to be reasonably necessary.
p.001373: (2) In the event of a vaccine-related death, an award of
p.001373: $250,000 for the estate of the deceased.
p.001373: (3)(A) In the case of any person who has sustained a vac- cine-related injury after attaining the age
p.001373: of 18 and whose earning capacity is or has been impaired by reason of such per- son’s vaccine-related injury for
p.001373: which compensation is to be awarded, compensation for actual and anticipated loss of earn- ings determined in
p.001373: accordance with generally recognized actu- arial principles and projections.
p.001373: (B) In the case of any person who has sustained a vaccine- related injury before attaining the age of 18 and whose
p.001373: earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which
p.001373: compensation is to be awarded and whose vaccine-related injury is of sufficient severity to per- mit reasonable
p.001373: anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after
p.001373: attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of
p.001373: workers in the private, non-farm sector, less appropriate taxes and the av- erage cost of a health insurance
p.001373: policy, as determined by the Secretary.
p.001373: (4) For actual and projected pain and suffering and emo-
p.001373: tional distress from the vaccine-related injury, an award not to exceed $250,000.
p.001373: (b) VACCINES ADMINISTERED BEFORE THE EFFECTIVE DATE.— Compensation awarded under the Program to a
p.001373: petitioner under section 2111 for a vaccine-related injury or death associated with the administration of
p.001373: a vaccine before the effective date of this part 9 may include the compensation described in paragraphs (1)(A)
p.001373: and (2) of subsection (a) and may also include an amount, not to exceed a combined total of $30,000, for—
p.001373: (1) lost earnings (as provided in paragraph (3) of sub- section (a)),
p.001373: (2) pain and suffering (as provided in paragraph (4) of subsection (a)), and
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 9 Effective October 1, 1988.
p.001373:
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
p.001373:
p.001373:
p.001373:
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p.001373:
p.001373: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1374
p.001373:
p.001373: (3) reasonable attorneys’ fees and costs (as provided in subsection (e) 10.
p.001373: (c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and
...

p.001419: (c) LIMITATION ON TOTAL PAYMENTS.—
p.001419: (1) Before March 1, 1989, for fiscal year 1989 and before September 1, 1989, for fiscal year 1990, the
p.001419: Secretary shall de-
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001419:
p.001419:
p.001419:
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p.001419:
p.001419: Sec. 2405 PUBLIC HEALTH SERVICE ACT 1420
p.001419:
p.001419:
p.001419:
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p.001419:
p.001419:
p.001419:
p.001419: January 30, 2020
p.001419:
p.001419: termine and publish the national average monthly payments, for extended care services under part A of title
p.001419: XVIII of the So- cial Security Act, for each resident of a skilled nursing facility the Secretary estimates will be
p.001419: paid in the fiscal year.
p.001419: (2) The Secretary may not make payments under section 2401(a) for a fiscal year to a State to the extent that
p.001419: the aver- age monthly payments for eligible individuals provided home and community-based health services
p.001419: under this part in the State exceeds 65 percent of the national average monthly pay- ments determined and
p.001419: published for the fiscal year under paragraph (1).
p.001419: SEC. 2405. ø300dd–4¿ REQUIREMENT OF REPORTS AND AUDITS BY STATES.
p.001419: (a) REPORTS.—
p.001419: (1) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State
p.001419: involved agrees to prepare and submit to the Secretary, by not later than January 1 following the fiscal year, an
p.001419: annual report in such form and containing such information as the Secretary determines (after consultation with the
p.001419: States and the Comptroller General of the United States) to be necessary for—
p.001419: (A) securing a record and a description of the purposes for which payments received by the State pursuant to sec- tion
p.001419: 2401(a) were expended and of the recipients of such payments;
p.001419: (B) determining whether the payments were expended in accordance with the purpose of this part; and
p.001419: (C) determining the percentage of payments received pursuant to section 2401(a) that were expended by the
p.001419: State for administrative expenses during the fiscal year in- volved.
p.001419: (2) Each report by a State under paragraph (1) for a fiscal year also shall include—
p.001419: (A) information on the number and type of eligible in- dividuals provided home and community-based health
p.001419: services by the State under this part for the fiscal year;
...

p.001491: State may not for the fiscal year involved exceed by more than 5 percent the amount of the grant pur-
p.001491: suant to this paragraph for the State for the preceding fiscal year, except that the limitation under this clause may
p.001491: not result in a grant pursuant to paragraph (1) for a fiscal year that is less than the minimum amount that
p.001491: applies to the State under such paragraph for such fiscal year.
p.001491: (ii) USE OF AMOUNTS INVOLVED.—For each of the fiscal years 2007 through 2012, amounts available as a
p.001491: result of the limitation under clause (i) shall be
p.001491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001491:
p.001491:
p.001491:
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p.001491:
p.001491: Sec. 2618 PUBLIC HEALTH SERVICE ACT 1492
p.001491: made available by the Secretary as additional amounts for grants pursuant to section 2620,
p.001491: subject to subparagraph (H).
p.001491: (F) 9 APPROPRIATIONS FOR TREATMENT DRUG PRO- GRAM.—
p.001491: (i) FORMULA GRANTS.—With respect to the fiscal year involved, if under section 2623 an appropriations Act
p.001491: provides an amount exclusively for carrying out section 2616, the portion of such amount allocated to a
p.001491: State shall be the product of—
p.001491: (I) 10 100 percent of such amount, less the percent- age reserved under clause (ii)(V); and
p.001491: (II) 10 the percentage constituted by the ratio of the State distribution factor for the State (as
p.001491: deter- mined under subparagraph (B)) to the sum of the State distribution factors for all States;
p.001491: which product shall then, as applicable, be increased under subparagraph (H).
p.001491: (ii) SUPPLEMENTAL TREATMENT DRUG GRANTS.—
p.001491: (I) IN GENERAL.—From amounts made avail- able under subclause (V), the Secretary shall award
p.001491: supplemental grants to States described in subclause (II) to enable such States to purchase and distribute to
p.001491: eligible individuals under section 2616(b) pharmaceutical therapeutics described under subsections (c)(2) and
p.001491: (e) of such section.
p.001491: (II) ELIGIBLE STATES.—For purposes of sub- clause (I), a State shall be an eligible State if the State did not
p.001491: have unobligated funds subject to re- allocation under section 2618(d) in the previous fiscal year and, in
p.001491: accordance with criteria estab- lished by the Secretary, demonstrates a severe need for a grant under
p.001491: this clause. For purposes of determining severe need, the Secretary shall consider eligibility standards,
p.001491: formulary composi- tion, the number of eligible individuals to whom a State is unable to provide therapeutics
p.001491: described in section 2616(a), and an unanticipated increase of eligible individuals with HIV/AIDS.
p.001491: (III) STATE REQUIREMENTS.—The Secretary may not make a grant to a State under this clause unless the State
p.001491: agrees that the State will make available (directly or through donations of public or private entities)
...

p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
p.001537:
p.001537: taining temporary or permanent injunctive relief with respect to any violation of this part.
p.001537: (b) FACILITATION OF INFORMATION ON VIOLATIONS.—The Sec- retary shall establish an administrative process
p.001537: for encouraging emergency response employees to provide information to the Sec- retary regarding violations
p.001537: of this part. As appropriate, the Sec- retary shall investigate alleged such violations and seek appro-
p.001537: priate injunctive relief.
p.001537: SEC. 2695I. ø300ff–140¿ APPLICABILITY OF PART.
p.001537: This part shall not apply in a State if the chief executive officer of the State certifies to the Secretary that
p.001537: the law of the State is substantially consistent with this part.
p.001537: TITLE XXVII—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
p.001537:
p.001537: PART A—INDIVIDUAL AND GROUP MARKET REFORMS
p.001537: Subpart I—General Reform
p.001537: SEC. 2701. ø300gg¿ FAIR HEALTH INSURANCE PREMIUMS.
p.001537: (a) 1 PROHIBITING DISCRIMINATORY PREMIUM RATES.—
p.001537: (1) IN GENERAL.—With respect to the premium rate charged by a health insurance issuer for health
p.001537: insurance cov- erage offered in the individual or small group market—
p.001537: (A) such rate shall vary with respect to the particular plan or coverage involved only by—
p.001537: (i) whether such plan or coverage covers an indi- vidual or family;
p.001537: (ii) rating area, as established in accordance with paragraph (2);
p.001537: (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with
p.001537: section 2707(c)); and
p.001537: (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
p.001537: (B) such rate shall not vary with respect to the par- ticular plan or coverage involved by any other
p.001537: factor not described in subparagraph (A).
p.001537: (2) RATING AREA.—
p.001537: (A) IN GENERAL.—Each State shall establish 1 or more rating areas within that State for purposes of applying the
p.001537: requirements of this title.
p.001537: (B) SECRETARIAL REVIEW.—The Secretary shall review the rating areas established by each State under subpara- graph
p.001537: (A) to ensure the adequacy of such areas for pur- poses of carrying out the requirements of this
p.001537: title. If the Secretary determines a State’s rating areas are not ade- quate, or that a State does not
p.001537: establish such areas, the Secretary may establish rating areas for that State.
p.001537:
p.001537:
p.001537:
p.001537: January 30, 2020
p.001537: 1 There are no subsections following subsection (a) in section 2701.
p.001537: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001537:
p.001537:
p.001537:
p.001537:
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p.001537:
p.001537: Sec. 2702 PUBLIC HEALTH SERVICE ACT 1538
p.001537:
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p.001537:
p.001537: January 30, 2020
p.001537:
p.001537: (3) PERMISSIBLE AGE BANDS.—The Secretary, in consulta- tion with the National Association of
p.001537: Insurance Commis- sioners, shall define the permissible age bands for rating pur- poses under paragraph
p.001537: (1)(A)(iii).
p.001537: (4) APPLICATION OF VARIATIONS BASED ON AGE OR TOBACCO USE.—With respect to family coverage under a group
p.001537: health plan or health insurance coverage, the rating variations per- mitted under clauses (iii) and (iv) of
p.001537: paragraph (1)(A) shall be applied based on the portion of the premium that is attrib- utable to each
p.001537: family member covered under the plan or cov- erage.
p.001537: (5) SPECIAL RULE FOR LARGE GROUP MARKET.—If a State permits health insurance issuers that offer coverage
p.001537: in the large group market in the State to offer such coverage through the State Exchange (as provided for under
p.001537: section 1312(f)(2)(B) of the Patient Protection and Affordable Care Act), the provi- sions of this
p.001537: subsection shall apply to all coverage offered in such market (other than self-insured group health plans
p.001537: of- fered in such market) in the State.
p.001537: SEC. 2702. ø300gg–1¿ GUARANTEED AVAILABILITY OF COVERAGE.
p.001537: (a) GUARANTEED ISSUANCE OF COVERAGE IN THE INDIVIDUAL AND GROUP MARKET.—Subject to subsections (b)
p.001537: through (e), each health insurance issuer that offers health insurance coverage in the individual or group market in
p.001537: a State must accept every employer and individual in the State that applies for such coverage.
p.001537: (b) ENROLLMENT.—
p.001537: (1) RESTRICTION.—A health insurance issuer described in subsection (a) may restrict enrollment in coverage
p.001537: described in such subsection to open or special enrollment periods.
p.001537: (2) ESTABLISHMENT.—A health insurance issuer described in subsection (a) shall, in accordance with the
...

p.001543: (D) ISSUER NOTICE.—In the case of an election under subparagraph (B) with respect to health insurance
p.001543: cov- erage offered by an issuer in the individual or group group 4 market, the issuer—
p.001543: (i) shall prominently state in any disclosure state- ments concerning the coverage, and to each employer at the
p.001543: time of the offer or sale of the coverage, that the issuer has made such election, and
p.001543: (ii) shall include in such statements a description of the effect of such election.
p.001543: (4) ESTABLISHMENT OF PERIOD.—Periods of creditable cov- erage with respect to an individual shall
p.001543: be established through presentation of certifications described in subsection
p.001543: (e) or in such other manner as may be specified in regulations.
p.001543: (d) EXCEPTIONS.—
p.001543: (1) EXCLUSION NOT APPLICABLE TO CERTAIN NEWBORNS.— Subject to paragraph (4), a group health plan, and a health
p.001543: in- surance issuer offering group or individual health insurance coverage, may not impose any preexisting
p.001543: condition exclusion in the case of an individual who, as of the last day of the 30- day period
p.001543: beginning with the date of birth, is covered under creditable coverage.
p.001543: (2) EXCLUSION NOT APPLICABLE TO CERTAIN ADOPTED CHIL- DREN.—Subject to paragraph (4), a group health plan,
p.001543: and a health insurance issuer offering group or individual health in- surance coverage, may not impose any
p.001543: preexisting condition exclusion in the case of a child who is adopted or placed for adoption before
p.001543: attaining 18 years of age and who, as of the last day of the 30-day period beginning on the date of the adop-
p.001543: tion or placement for adoption, is covered under creditable cov- erage. The previous sentence shall not apply to
p.001543: coverage before the date of such adoption or placement for adoption.
p.001543: (3) EXCLUSION NOT APPLICABLE TO PREGNANCY.—A group health plan, and health insurance issuer offering group or
p.001543: indi- vidual health insurance coverage, may not impose any pre- existing condition exclusion relating to
p.001543: pregnancy as a pre- existing condition.
p.001543: (4) LOSS IF BREAK IN COVERAGE.—Paragraphs (1) and (2) shall no longer apply to an individual after the end of
p.001543: the first
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p.001543: 4 So in law. See amendment made by section 1563(c)(1)(A)(ii)(II) (relating to conforming
p.001543: amendments--originally designated as section 1562 and redesignated as section 1563 by section 10107(b)(1)) of Public
p.001543: Law 111–148.
p.001543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001545: 1545
p.001545: PUBLIC HEALTH SERVICE ACT
p.001545: Sec. 2704
p.001545:
p.001545: 63-day period during all of which the individual was not cov- ered under any creditable coverage.
p.001545: (e) CERTIFICATIONS AND DISCLOSURE OF COVERAGE.—
p.001545: (1) REQUIREMENT FOR CERTIFICATION OF PERIOD OF CRED- ITABLE COVERAGE.—
p.001545: (A) IN GENERAL.—A group health plan, and a health insurance issuer offering group or individual health insur-
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p.001553: (D) A program that reimburses individuals for the costs of smoking cessation programs without regard to
p.001553: whether the individual quits smoking.
p.001553: (E) A program that provides a reward to individuals for attending a periodic health education seminar.
p.001553: (3) WELLNESS PROGRAMS SUBJECT TO REQUIREMENTS.—If any of the conditions for obtaining a premium discount,
p.001553: rebate, or reward under a wellness program as described in paragraph (1)(C) is based on an individual satisfying
p.001553: a standard that is related to a health status factor, the wellness program shall not violate this
p.001553: section if the following requirements are com- plied with:
p.001553: (A) The reward for the wellness program, together with the reward for other wellness programs with
p.001553: respect to the plan that requires satisfaction of a standard related to a health status factor, shall not exceed 30
p.001553: percent of the cost of employee-only coverage under the plan. If, in addi- tion to employees or individuals, any
p.001553: class of dependents (such as spouses or spouses and dependent children) may participate fully in the
p.001553: wellness program, such reward shall not exceed 30 percent of the cost of the coverage in which an
p.001553: employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of cov-
p.001553: erage shall be determined based on the total amount of employer and employee contributions for the benefit
p.001553: pack- age under which the employee is (or the employee and any dependents are) receiving coverage. A reward may
p.001553: be in the form of a discount or rebate of a premium or contribu-
p.001553: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001553:
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p.001553: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1554
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p.001553: January 30, 2020
p.001553:
p.001553: tion, a waiver of all or part of a cost-sharing mechanism (such as deductibles, copayments, or
p.001553: coinsurance), the ab- sence of a surcharge, or the value of a benefit that would otherwise not be provided
p.001553: under the plan. The Secretaries of Labor, Health and Human Services, and the Treasury may increase the
p.001553: reward available under this subpara- graph to up to 50 percent of the cost of coverage if the Sec- retaries
p.001553: determine that such an increase is appropriate.
...

p.001555: individual health insurance coverage.
p.001555: SEC. 2707. ø300gg–6¿ COMPREHENSIVE HEALTH INSURANCE COV- ERAGE.
p.001555: (a) COVERAGE FOR ESSENTIAL HEALTH BENEFITS PACKAGE.—A health insurance issuer that offers health insurance
p.001555: coverage in the individual or small group market shall ensure that such coverage includes the essential
p.001555: health benefits package required under sec- tion 1302(a) of the Patient Protection and Affordable Care Act.
p.001555: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001555:
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p.001557: 1557
p.001557: PUBLIC HEALTH SERVICE ACT
p.001557: Sec. 2709
p.001557:
p.001557: (b) COST-SHARING UNDER GROUP HEALTH PLANS.—A group health plan shall ensure that any annual
p.001557: cost-sharing imposed under the plan does not exceed the limitations provided for under paragraph (1) of
p.001557: section 1302(c).
p.001557: (c) CHILD-ONLY PLANS.—If a health insurance issuer offers health insurance coverage in any level of
p.001557: coverage specified under section 1302(d) of the Patient Protection and Affordable Care Act, the issuer
p.001557: shall also offer such coverage in that level as a plan in which the only enrollees are individuals
p.001557: who, as of the beginning of a plan year, have not attained the age of 21.
p.001557: (d) DENTAL ONLY.—This section shall not apply to a plan de- scribed in section 1302(d)(2)(B)(ii)(I).
p.001557: SEC. 2708. ø300gg–7¿ PROHIBITION ON EXCESSIVE WAITING PERIODS.
p.001557: A group health plan and a health insurance issuer offering group health insurance coverage shall not apply any
p.001557: waiting period (as defined in section 2704(b)(4)) that exceeds 90 days.
p.001557: SEC. 2709. ø300gg–8¿ COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL TRIALS. 6
p.001557: (a) COVERAGE.—
p.001557: (1) IN GENERAL.—If a group health plan or a health insur- ance issuer offering group or individual health
p.001557: insurance cov- erage provides coverage to a qualified individual, then such plan or issuer—
p.001557: (A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);
p.001557: (B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of
p.001557: routine patient costs for items and services furnished in connection with participation in the trial; and
p.001557: (C) may not discriminate against the individual on the basis of the individual’s participation in such trial.
p.001557: (2) ROUTINE PATIENT COSTS.—
p.001557: (A) INCLUSION.—For purposes of paragraph (1)(B), subject to subparagraph (B), routine patient costs
p.001557: include all items and services consistent with the coverage pro- vided in the plan (or coverage) that is
p.001557: typically covered for a qualified individual who is not enrolled in a clinical trial.
p.001557: (B) EXCLUSION.—For purposes of paragraph (1)(B), routine patient costs does not include—
p.001557: (i) the investigational item, device, or service, itself;
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p.001561: January 30, 2020
p.001561:
p.001561: scribed in subsection (a)(1) or (a)(2) or a guideline under sub- section (a)(3) is issued and the plan year
p.001561: with respect to which the requirement described in subsection (a) is effective with re- spect to the service
p.001561: described in such recommendation or guideline.
p.001561: (2) MINIMUM.—The interval described in paragraph (1) shall not be less than 1 year.
p.001561: (c) VALUE-BASED INSURANCE DESIGN.—The Secretary may de- velop guidelines to permit a group health plan and a
p.001561: health insur- ance issuer offering group or individual health insurance coverage to utilize value-based
p.001561: insurance designs.
p.001561: SEC. 2714. ø300gg–14¿ EXTENSION OF DEPENDENT COVERAGE.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage that provides dependent coverage of children shall continue to make such coverage available for
p.001561: an adult child until the child turns 26 years of age. Nothing in this section shall require a health plan or a
p.001561: health insurance issuer described in the preceding sentence to make coverage available for a child of a
p.001561: child receiving dependent coverage.
p.001561: (b) REGULATIONS.—The Secretary shall promulgate regulations to define the dependents to which coverage shall be made
p.001561: available under subsection (a).
p.001561: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to modify the definition of ‘‘dependent’’
p.001561: as used in the In- ternal Revenue Code of 1986 with respect to the tax treatment of the cost of coverage.
p.001561: SEC. 2715. ø300gg–15¿ DEVELOPMENT AND UTILIZATION OF UNIFORM EXPLANATION OF COVERAGE DOCUMENTS AND STAND-
p.001561: ARDIZED DEFINITIONS.
p.001561: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Patient Protection and
p.001561: Affordable Care Act, the Secretary shall develop standards for use by a group health plan and a health
p.001561: insurance issuer offering group or individual health insurance coverage, in compiling and providing to
p.001561: applicants, en- rollees, and policyholders or certificate holders a summary of bene- fits and coverage explanation
p.001561: that accurately describes the benefits and coverage under the applicable plan or coverage. In developing such
p.001561: standards, the Secretary shall consult with the National Asso- ciation of Insurance Commissioners (referred to in
...

p.001561: (b) REQUIREMENTS.—The standards for the summary of bene- fits and coverage developed under subsection (a)
p.001561: shall provide for the following:
p.001561: (1) APPEARANCE.—The standards shall ensure that the summary of benefits and coverage is presented in a
p.001561: uniform format that does not exceed 4 pages in length and does not in- clude print smaller than 12-point font.
p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001563: 1563
p.001563: PUBLIC HEALTH SERVICE ACT
p.001563: Sec. 2715
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p.001563: January 30, 2020
p.001563: (2) LANGUAGE.—The standards shall ensure that the sum- mary is presented in a culturally and linguistically appropriate
p.001563: manner and utilizes terminology understandable by the aver- age plan enrollee.
p.001563: (3) CONTENTS.—The standards shall ensure that the sum- mary of benefits and coverage includes—
p.001563: (A) uniform definitions of standard insurance terms and medical terms (consistent with subsection (g)) so
p.001563: that consumers may compare health insurance coverage and understand the terms of coverage (or exception to
p.001563: such coverage);
p.001563: (B) a description of the coverage, including cost shar- ing for—
p.001563: (i) each of the categories of the essential health benefits described in subparagraphs (A) through (J) of
p.001563: section 1302(b)(1) of the Patient Protection and Afford- able Care Act; and
p.001563: (ii) other benefits, as identified by the Secretary;
p.001563: (C) the exceptions, reductions, and limitations on cov- erage;
p.001563: (D) the cost-sharing provisions, including deductible, coinsurance, and co-payment obligations;
p.001563: (E) the renewability and continuation of coverage pro- visions;
p.001563: (F) a coverage facts label that includes examples to il- lustrate common benefits scenarios, including pregnancy
p.001563: and serious or chronic medical conditions and related cost sharing, such scenarios to be based on recognized
p.001563: clinical practice guidelines;
p.001563: (G) a statement of whether the plan or coverage—
p.001563: (i) provides minimum essential coverage (as de- fined under section 5000A(f) of the Internal Revenue Code
p.001563: 1986); and
p.001563: (ii) ensures that the plan or coverage share of the total allowed costs of benefits provided under the plan or
p.001563: coverage is not less than 60 percent of such costs;
p.001563: (H) a statement that the outline is a summary of the policy or certificate and that the coverage
...

p.001595: (2) CHOICE OF MOST POPULAR POLICY FORMS.—The require- ment of this paragraph is met, for health insurance
p.001595: coverage policy forms offered by an issuer in the individual market, if the issuer offers the policy
p.001595: forms for individual health insur- ance coverage with the largest, and next to largest, premium volume of
p.001595: all such policy forms offered by the issuer in the State or applicable marketing or service area (as
p.001595: may be pre- scribed in regulation) by the issuer in the individual market in the period involved.
p.001595: (3) CHOICE OF 2 POLICY FORMS WITH REPRESENTATIVE COVERAGE.—
p.001595: (A) IN GENERAL.—The requirement of this paragraph is met, for health insurance coverage policy forms
p.001595: offered by an issuer in the individual market, if the issuer offers a lower-level coverage policy form
p.001595: (as defined in subpara- graph (B)) and a higher-level coverage policy form (as de- fined in subparagraph
p.001595: (C)) each of which includes benefits substantially similar to other individual health insurance coverage offered
p.001595: by the issuer in that State and each of which is covered under a method described in section
p.001595: 2744(c)(3)(A) (relating to risk adjustment, risk spreading, or financial subsidization).
p.001595: (B) LOWER-LEVEL OF COVERAGE DESCRIBED.—A policy form is described in this subparagraph if the actuarial
p.001595: value of the benefits under the coverage is at least 85 per- cent but not greater than 100 percent of a weighted aver-
p.001595: age (described in subparagraph (D)).
p.001595: (C) HIGHER-LEVEL OF COVERAGE DESCRIBED.—A policy form is described in this subparagraph if—
p.001595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001597: 1597
p.001597: PUBLIC HEALTH SERVICE ACT
p.001597: Sec. 2741
p.001597:
p.001597: (i) the actuarial value of the benefits under the coverage is at least 15 percent greater than the
p.001597: actu- arial value of the coverage described in subparagraph
p.001597: (B) offered by the issuer in the area involved; and
p.001597: (ii) the actuarial value of the benefits under the coverage is at least 100 percent but not greater
p.001597: than 120 percent of a weighted average (described in sub- paragraph (D)).
p.001597: (D) WEIGHTED AVERAGE.—For purposes of this paragraph, the weighted average described in this sub-
p.001597: paragraph is the average actuarial value of the benefits provided by all the health insurance coverage
p.001597: issued (as elected by the issuer) either by that issuer or by all issuers in the State in the individual market
p.001597: during the previous year (not including coverage issued under this section), weighted by enrollment for the
p.001597: different coverage.
p.001597: (4) ELECTION.—The issuer elections under this subsection shall apply uniformly to all eligible individuals in the
p.001597: State for that issuer. Such an election shall be effective for policies of- fered during a period of not
p.001597: shorter than 2 years.
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p.001615: (14) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, Puerto Rico,
p.001615: the Virgin Is- lands, Guam, American Samoa, and the Northern Mariana Is- lands.
p.001615: (15) FAMILY MEMBER.—The term ‘‘family member’’ means, with respect to any individual—
p.001615: (A) a dependent (as such term is used for purposes of section 2701(f)(2)) of such individual; and
p.001615: (B) any other individual who is a first-degree, second- degree, third-degree, or fourth-degree relative of such indi-
p.001615: vidual or of an individual described in subparagraph (A).
p.001615: (16) GENETIC INFORMATION.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic information’’ means, with respect to any individual, information about—
p.001615: (i) such individual’s genetic tests,
p.001615: (ii) the genetic tests of family members of such in- dividual, and
p.001615: (iii) the manifestation of a disease or disorder in family members of such individual.
p.001615: (B) INCLUSION OF GENETIC SERVICES AND PARTICIPA- TION IN GENETIC RESEARCH.—Such term includes, with re-
p.001615: spect to any individual, any request for, or receipt of, ge- netic services, or participation in
p.001615: clinical research which includes genetic services, by such individual or any family member of such individual.
p.001615: (C) EXCLUSIONS.—The term ‘‘genetic information’’ shall not include information about the sex or age
p.001615: of any individual.
p.001615: (17) GENETIC TEST.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic test’’ means an analysis of human DNA, RNA, chromosomes, proteins, or
p.001615: metabolites, that detects genotypes, mutations, or chromo- somal changes.
p.001615: (B) EXCEPTIONS.—The term ‘‘genetic test’’ does not mean—
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p.001615: (i) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes;
p.001615: or
p.001615: (ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder,
p.001615: or pathological condition that could reasonably be de- tected by a health care professional with
p.001615: appropriate training and expertise in the field of medicine in- volved.
p.001615: (18) GENETIC SERVICES.—The term ‘‘genetic services’’ means—
p.001615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001647: (1) how the applicant proposes to develop or expand pro- grams to address vector-borne disease
p.001647: risks, including through—
p.001647: (A) related training and workforce development;
p.001647: (B) programmatic efforts to improve capacity to iden- tify, report, prevent, and respond to such disease
p.001647: and re- lated outbreaks; and
p.001647: (C) other relevant activities identified by the Director of the Centers for Disease Control and
p.001647: Prevention, as ap- propriate;
p.001647: (2) the manner in which the applicant will coordinate with other Federal, Tribal, and State agencies and programs, as
p.001647: ap- plicable, related to vector-borne diseases, as well as other rel- evant public and private organizations
p.001647: or agencies; and
p.001647: (3) the manner in which the applicant will evaluate the ef- fectiveness of any program carried out under the
p.001647: cooperative agreement.
p.001647: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purposes of carrying out this section, there are authorized
p.001647: to be appropriated
p.001647: $20,000,000 for each of fiscal years 2021 through 2025.
p.001647: TITLE XXIX—LIFESPAN RESPITE CARE
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p.001647: January 30, 2020
p.001647: SEC. 2901. ø300ii¿ DEFINITIONS.
p.001647: In this title:
p.001647: (1) ADULT WITH A SPECIAL NEED.—The term ‘‘adult with a special need’’ means a person 18 years of age or older
p.001647: who re- quires care or supervision to—
p.001647: (A) meet the person’s basic needs;
p.001647: (B) prevent physical self-injury or injury to others; or
p.001647: (C) avoid placement in an institutional facility.
p.001647: (2) AGING AND DISABILITY RESOURCE CENTER.—The term ‘‘aging and disability resource center’’ means an
p.001647: entity admin- istering a program established by the State, as part of the State’s system of long-term
p.001647: care, to provide a coordinated sys- tem for providing—
p.001647: (A) comprehensive information on available public and private long-term care programs, options, and resources;
p.001647: (B) personal counseling to assist individuals in assess- ing their existing or anticipated long-term care needs, and
p.001647: developing and implementing a plan for long-term care de- signed to meet their specific needs and circumstances; and
p.001647: (C) consumer access to the range of publicly supported long-term care programs for which consumers may be eli-
p.001647: gible, by serving as a convenient point of entry for such programs.
p.001647: (3) CHILD WITH A SPECIAL NEED.—The term ‘‘child with a special need’’ means an individual less than 18
p.001647: years of age who requires care or supervision beyond that required of chil- dren generally to—
p.001647: (A) meet the child’s basic needs; or
p.001647: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001647:
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p.001649: PUBLIC HEALTH SERVICE ACT
p.001649: Sec. 2902
p.001649:
p.001649: (B) prevent physical injury, self-injury, or injury to others.
p.001649: (4) ELIGIBLE STATE AGENCY.—The term ‘‘eligible State agency’’ means a State agency that—
p.001649: (A) administers the State’s program under the Older Americans Act of 1965, administers the State’s
p.001649: program under title XIX of the Social Security Act, or is designated by the Governor of such State to administer
p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
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p.001649: January 30, 2020
p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
...

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p.001649: January 30, 2020
p.001649:
p.001649: (c) FEDERAL LIFESPAN APPROACH.—In carrying out this section, the Secretary shall work in cooperation with
p.001649: the National Family Caregiver Support Program of the Administration on Aging and other respite care
p.001649: programs within the Department of Health and Human Services to ensure coordination of respite care
p.001649: services for family caregivers of children and adults with special needs.
p.001649: (d) APPLICATION.—
p.001649: (1) SUBMISSION.—Each Governor desiring the eligible State agency of his or her State to receive a grant or
p.001649: cooperative agreement under this section shall submit an application on behalf of such agency to the
p.001649: Secretary at such time, in such manner, and containing such information as the Secretary shall require.
p.001649: (2) CONTENTS.—Each application submitted under this sec- tion shall include—
p.001649: (A) a description of the eligible State agency’s—
p.001649: (i) ability to work with other State and commu- nity-based agencies;
p.001649: (ii) understanding of respite care and family care- giver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) capacity to ensure meaningful involvement of family members, family caregivers, and care recipi-
p.001649: ents;
p.001649: (B) with respect to the population of family caregivers to whom respite care information or services will be
p.001649: pro- vided or for whom respite care workers and volunteers will be recruited and trained, a description of—
p.001649: (i) the population of family caregivers;
p.001649: (ii) the extent and nature of the respite care needs of that population;
p.001649: (iii) existing respite care services for that popu- lation, including numbers of family caregivers being
p.001649: served and extent of unmet need;
p.001649: (iv) existing methods or systems to coordinate res- pite care information and services to the population at the State
p.001649: and local level and extent of unmet need;
p.001649: (v) how respite care information dissemination and coordination, respite care services, respite care
p.001649: worker and volunteer recruitment and training pro- grams, or training programs for family caregivers that assist
p.001649: such family caregivers in making informed deci- sions about respite care services will be provided using grant or
p.001649: cooperative agreement funds;
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p.001659:
p.001659: January 30, 2020
p.001659:
p.001659: House of Representatives and the Senate a report on any additional funding or authority the Coordinator or the
p.001659: HIT Advisory Committee requires to evaluate and develop standards, implementation specifications, and
p.001659: certification criteria, or to achieve full participation of stakeholders in the adoption of a nationwide health
p.001659: information technology infrastructure that allows for the electronic use and ex- change of health information.
p.001659: (B) IMPLEMENTATION REPORT.—The National Coordi- nator shall prepare a report that identifies lessons learned from
p.001659: major public and private health care systems in their implementation of health information technology, includ- ing
p.001659: information on whether the technologies and practices developed by such systems may be applicable to and usa-
p.001659: ble in whole or in part by other health care providers.
p.001659: (C) ASSESSMENT OF IMPACT OF HIT ON COMMUNITIES WITH HEALTH DISPARITIES AND UNINSURED, UNDERINSURED,
p.001659: AND MEDICALLY UNDERSERVED AREAS.—The National Coor- dinator shall assess and publish the impact of health infor-
p.001659: mation technology in communities with health disparities and in areas with a high proportion of individuals who
p.001659: are uninsured, underinsured, and medically underserved indi- viduals (including urban and rural areas) and
p.001659: identify practices to increase the adoption of such technology by health care providers in such communities,
p.001659: and the use of health information technology to reduce and better man- age chronic diseases.
p.001659: (D) EVALUATION OF BENEFITS AND COSTS OF THE ELEC- TRONIC USE AND EXCHANGE OF HEALTH INFORMATION.—The
p.001659: National Coordinator shall evaluate and publish evidence on the benefits and costs of the electronic use
p.001659: and ex- change of health information and assess to whom these benefits and costs accrue.
p.001659: (E) RESOURCE REQUIREMENTS.—The National Coordi- nator shall estimate and publish resources required annu- ally to
p.001659: reach the goal of utilization of an electronic health record for each person in the United States by 2014,
p.001659: in- cluding—
p.001659: (i) the required level of Federal funding;
p.001659: (ii) expectations for regional, State, and private in- vestment;
p.001659: (iii) the expected contributions by volunteers to ac- tivities for the utilization of such records; and
p.001659: (iv) the resources needed to establish a health in- formation technology workforce sufficient to support this
p.001659: effort (including education programs in medical informatics and health information management).
p.001659: (7) ASSISTANCE.—The National Coordinator may provide fi- nancial assistance to consumer advocacy groups and
p.001659: not-for- profit entities that work in the public interest for purposes of defraying the cost to such
p.001659: groups and entities to participate under, whether in whole or in part, the National Technology Transfer
p.001659: Act of 1995 (15 U.S.C. 272 note).
p.001659: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: 1665
p.001665: PUBLIC HEALTH SERVICE ACT
p.001665: Sec. 3002
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p.001665: January 30, 2020
p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
...

p.001692:
p.001692: January 30, 2020
p.001692: SEC. 3021. ø300jj–51¿ HEALTH INFORMATION TECHNOLOGY ENROLL- MENT STANDARDS AND PROTOCOLS.
p.001692: (a) IN GENERAL.—
p.001692: (1) STANDARDS AND PROTOCOLS.—Not later than 180 days after the date of enactment of this title, the Secretary,
p.001692: in con- sultation with the HIT Advisory Committee, shall develop interoperable and secure standards and
p.001692: protocols that facilitate enrollment of individuals in Federal and State health and human services programs, as
p.001692: determined by the Secretary.
p.001692: (2) METHODS.—The Secretary shall facilitate enrollment in such programs through methods determined appropriate by the
p.001692: Secretary, which shall include providing individuals and third parties authorized by such individuals and their
p.001692: designees no- tification of eligibility and verification of eligibility required under such programs.
p.001692: (b) CONTENT.—The standards and protocols for electronic en- rollment in the Federal and State programs described
p.001692: in subsection
p.001692: (a) shall allow for the following:
p.001692: (1) Electronic matching against existing Federal and State data, including vital records, employment history,
p.001692: enrollment systems, tax records, and other data determined appropriate by the Secretary to serve as
p.001692: evidence of eligibility and in lieu of paper-based documentation.
p.001692: (2) Simplification and submission of electronic documenta- tion, digitization of documents, and systems verification of
p.001692: eli- gibility.
p.001692: (3) Reuse of stored eligibility information (including docu- mentation) to assist with retention of eligible
p.001692: individuals.
p.001692: (4) Capability for individuals to apply, recertify and man- age their eligibility information online,
p.001692: including at home, at points of service, and other community-based locations.
p.001692: (5) Ability to expand the enrollment system to integrate new programs, rules, and functionalities, to
p.001692: operate at in- creased volume, and to apply streamlined verification and eli- gibility processes to other
p.001692: Federal and State programs, as ap- propriate.
p.001692: (6) Notification of eligibility, recertification, and other needed communication regarding eligibility,
p.001692: which may include communication via email and cellular phones.
p.001692: (7) Other functionalities necessary to provide eligibles with streamlined enrollment process.
p.001692: (c) APPROVAL AND NOTIFICATION.—With respect to any stand- ard or protocol developed under subsection
p.001692: (a) that has been ap- proved by the HIT Advisory Committee, the Secretary—
p.001692: (1) shall notify States of such standards or protocols; and
p.001692: (2) may require, as a condition of receiving Federal funds for the health information technology investments,
p.001692: that States or other entities incorporate such standards and protocols into such investments.
p.001692: (d) GRANTS FOR IMPLEMENTATION OF APPROPRIATE ENROLL-
p.001692: MENT HIT.—
p.001692: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001692:
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p.001693: PUBLIC HEALTH SERVICE ACT
p.001693: Sec. 3022
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p.001737: 1737
p.001737: PUBLIC HEALTH SERVICE ACT
p.001737:
p.001737: Subtitle D—Funding
p.001737: Sec. 3351
p.001737:
p.001737: SEC. 3351. ø42 U.S.C. 300mm–61¿ WORLD TRADE CENTER HEALTH PRO- GRAM FUND.
p.001737: (a) ESTABLISHMENT OF FUND.—
p.001737: (1) IN GENERAL.—There is established a fund to be known as the World Trade Center Health Program Fund (referred
p.001737: to in this section as the ‘‘Fund’’).
p.001737: (2) FUNDING.—Out of any money in the Treasury not oth- erwise appropriated, there shall be deposited into the
p.001737: Fund for fiscal year 2016 and each subsequent fiscal year through fiscal year 2090—
p.001737: (A) the Federal share, consisting of an amount equal
p.001737:
p.001737: to—
p.001737: (i) for fiscal year 2016, $330,000,000;
p.001737: (ii) for fiscal year 2017, $345,610,000;
p.001737: (iii) for fiscal year 2018, $380,000,000;
p.001737: (iv) for fiscal year 2019, $440,000,000; (v) for fiscal year 2020, $485,000,000;
p.001737: (vi) for fiscal year 2021, $501,000,000;
p.001737: (vii) for fiscal year 2022, $518,000,000;
p.001737: (viii) for fiscal year 2023, $535,000,000;
p.001737: (ix) for fiscal year 2024, $552,000,000;
p.001737: (x) for fiscal year 2025, $570,000,000; and
p.001737: (xi) for each subsequent fiscal year through fiscal year 2090, the amount specified under this subpara-
p.001737: graph for the previous fiscal year increased by the per- centage increase in the consumer price index for all
p.001737: urban consumers (all items; United States city aver- age) as estimated by the Secretary for the 12-month
p.001737: period ending with March of the previous year; plus
p.001737: (B) the New York City share, consisting of the amount
p.001737:
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p.001737: January 30, 2020
p.001737: contributed under the contract under section 3331(d).
p.001737: (3) CONTRACT REQUIREMENT.—
p.001737: (A) IN GENERAL.—No funds may be disbursed from the Fund unless New York City has entered into a contract with
p.001737: the WTC Program Administrator under section 3331(d)(1).
p.001737: (B) BREACH OF CONTRACT.—In the case of a failure to pay the amount so required under the contract—
p.001737: (i) the amount is recoverable under subparagraph (E)(ii) of such section;
p.001737: (ii) such failure shall not affect the disbursement of amounts from the Fund; and
p.001737: (iii) the Federal share described in paragraph (2)(A) shall not be increased by the amount so unpaid.
p.001737: (4) AMOUNTS FROM PRIOR FISCAL YEARS.—Amounts that were deposited, or identified for deposit, into the Fund
p.001737: for any fiscal year under paragraph (2), as such paragraph was in ef- fect on the day before the date
p.001737: of enactment of the James Zadroga 9/11 Health and Compensation Reauthorization Act, that were not expended
p.001737: in carrying out this title for any such
p.001737: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000101: facilitate an effective audit.
p.000101: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000101: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000101: records of the recipient of grants under sub- section (a) that are pertinent to such grants.
p.000101: (g)(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to
p.000101: a State or to an agency or a political subdivision of a State under provisions of Federal law (other
p.000101: than this section) and which are available for the conduct of
p.000101: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000101:
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p.000101: Sec. 317 PUBLIC HEALTH SERVICE ACT 102
p.000101:
p.000101: preventive health service programs from being used on connection with programs assisted through grants under
p.000101: subsection (a).
p.000101: (2) Nothing in this section shall be construed to require any State or any agency or political
p.000101: subdivision of a State to have a preventive health service program which would require any person, who objects to
p.000101: any treatment provided under such a program, to be treated or to have any child or ward treated under such
p.000101: program.
p.000101: (h) The Secretary shall include, as part of the report required by section 1705, a report on the
p.000101: extent of the problems presented by the diseases and conditions referred to in subsection (j) on the
p.000101: amount of funds obligated under grants under subsection (a) in the preceding fiscal year for each of the
p.000101: programs listed in subsection (j); and on the effectiveness of the activities assisted under grants under
p.000101: subsection (a) in controlling such diseases and conditions.
p.000101: (i) The Secretary may provide technical assistance to States, State health authorities, and other public
p.000101: entities in connection with the operation of their preventive health service programs.
p.000101: (j)(1) Except for grants for immunization programs the author- ization of appropriations for which are
p.000101: established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to
p.000101: immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are
p.000101: author- ized to be appropriated such sums as may be necessary. Not more than 10 percent ot the total amount
p.000101: appropriated under the pre- ceding sentence for any fiscal year shall be available for grants under
p.000101: subsection (k)(1) for such fiscal year.
p.000101: (2) For grants under subsection (a) for preventive health serv- ice programs for the provision without charge of
p.000101: immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be
p.000101: appropriated such sums as may be nec- essary.
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p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000109:
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p.000111: 111
p.000111: PUBLIC HEALTH SERVICE ACT
p.000111: Sec. 317C
p.000111:
p.000111: (C) to provide information and education to the public on the prevention of such defects and disabilities;
p.000111: (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary
p.000111: health conditions among individuals with disabilities; and
p.000111: (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common
p.000111: permanently disabling birth defect.
p.000111: (3) FOLIC ACID.—The Secretary shall carry out section 317J through the Center.
p.000111: (4) CERTAIN PROGRAMS.—
p.000111: (A) TRANSFERS.—All programs and functions described in subparagraph (B) are transferred to the Center, effec-
p.000111: tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health
p.000111: Act of 2000 10.
p.000111: (B) RELEVANT PROGRAMS.—The programs and func- tions described in this subparagraph are all programs and functions
p.000111: that—
p.000111: (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn
p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
p.000111: sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the
p.000111: Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act
p.000111: referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of
p.000111: the amounts, or the avail- ability of the amounts with respect to the purposes for which the amounts may
p.000111: be expended.
p.000111: (b) GRANTS AND CONTRACTS.—
p.000111: (1) IN GENERAL.—In carrying out subsection (a), the Sec- retary may make grants to and enter into contracts
p.000111: with public and nonprofit private entities.
p.000111: (2) SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.—
p.000111: (A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary
p.000111: may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the
p.000111: recipient in car- rying out the purposes for which the award is made and, for such purposes, may detail
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p.000125: Sec. 317K PUBLIC HEALTH SERVICE ACT 126
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p.000125: (2) ACTIVITIES.—For the purpose described in paragraph (1), the Secretary, acting through the Director of
p.000125: the Centers for Disease Control and Prevention, may carry out the fol- lowing activities:
p.000125: (A) The Secretary may continue and improve activities related to a national maternal mortality data collection
p.000125: and surveillance program to identify and support the re- view of pregnancy-associated deaths and
p.000125: pregnancy-related deaths that occur during, or within 1 year following, preg- nancy.
p.000125: (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and
p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
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p.000129: Indian Self- Determination and Education Assistance Act;
p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
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p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
p.000135: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000135: such Act;
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p.000135: (B) the head start program established under the
p.000135: Head Start Act (42 U.S.C. 9831 et seq.);
p.000135: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000135: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000135: (D) local public and private elementary or secondary schools; or
p.000135: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000135: U.S.C. 1437a).
p.000135: (c) PERFORMANCE MEASURES.—The Secretary shall establish needs indicators and performance measures to evaluate the
p.000135: activi- ties carried out under grants awarded under this section. Such in- dicators shall be commensurate with
p.000135: national measures of mater- nal and child health programs and shall be developed in consulta- tion with the
p.000135: Director of the Centers for Disease Control and Pre- vention.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000135: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000137: PUBLIC HEALTH SERVICE ACT
p.000137: Sec. 317P
p.000137:
p.000137: HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 13)
p.000137: SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall—
p.000137: (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe-
p.000137: cial studies that would determine the prevalence in var- ious age groups and populations of specific types of
p.000137: human papillomavirus (referred to in this section as ‘‘HPV’’) in dif- ferent sites in various regions of
p.000137: the United States, through collection of special specimens for HPV using a va- riety of laboratory-based testing
p.000137: and diagnostic tools; and
p.000137: (B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
p.000137: (2) REPORT.—The Secretary shall make a progress report to the Congress with respect to paragraph (1) no
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p.000161: (II) providing for optional registration to partici- pate in volunteer services during processes related
p.000161: to State medical licensing, registration, or certification or renewal of such licensing, registration, or
p.000161: certification; or
p.000161: (III) other mechanisms as the State determines appropriate;
p.000161: (v) a description of how the entity will include the State Unit on Aging in public health emergency pre-
p.000161: paredness;
p.000161: (vi) a description of how, as appropriate, the enti- ty may partner with relevant public and private stake- holders,
p.000161: including public health agencies with specific expertise that may be relevant to public health secu- rity,
p.000161: such as environmental health agencies, in public health emergency preparedness and response;
p.000161: (vii) a description of how, as applicable, such enti- ty may integrate information to account for individ- uals
p.000161: with behavioral health needs following a public health emergency;
p.000161: (viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency
p.000161: preparedness and response plans in public health emergency preparedness, including State educational
p.000161: agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965) and State child care lead
p.000161: agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);
p.000161: (ix) in the case of entities that operate on the United States-Mexico border or the United States-
p.000161: Canada border, a description of the activities such en- tity will carry out under the agreement that are spe-
p.000161: cific to the border area including disease detection, identification, investigation, and preparedness and re-
p.000161: sponse activities related to emerging diseases and in- fectious disease outbreaks whether naturally occurring
p.000161:
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p.000161: January 30, 2020
p.000161: 18 Margin for clause (iv) is so in law.
p.000161:
p.000161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000161: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 162
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p.000161: or due to bioterrorism, consistent with the require- ments of this section;
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p.000185: activity.
p.000185: SEC. 319D–1. ø247d-4b¿ CHILDREN’S PREPAREDNESS UNIT.
p.000185: (a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.— The Secretary, acting through the Director of the
p.000185: Centers for Dis- ease Control and Prevention (referred to in this subsection as the ‘‘Director’’), shall
p.000185: maintain an internal team of experts, to be known as the Children’s Preparedness Unit (referred to in
p.000185: this sub- section as the ‘‘Unit’’), to work collaboratively to provide guidance on the considerations for, and
p.000185: the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the
p.000185: Director regarding emergency preparedness and response ef- forts pertaining to children at the Centers for
p.000185: Disease Control and Prevention.
p.000185: (b) EXPERTISE.—The team described in subsection (a) shall in- clude one or more pediatricians, which may be a
p.000185: developmental-be- havioral pediatrician, and may also include behavioral scientists, child psychologists,
p.000185: epidemiologists, biostatisticians, health commu- nications staff, and individuals with other areas of expertise, as the
p.000185: Secretary determines appropriate.
p.000185: (c) DUTIES.—The team described in subsection (a) may—
p.000185: (1) assist State, local, Tribal, and territorial emergency planning and response activities related to children,
p.000185: which may include developing, identifying, and sharing best practices;
p.000185: (2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public
p.000185: health of- ficials to improve preparedness and response capabilities with respect to the needs of children,
p.000185: including providing such tech- nical assistance, training, and consultation to eligible entities in order to
p.000185: support the achievement of measurable evidence- based benchmarks and objective standards applicable to sec-
p.000185: tions 319C–1 and 319C–2;
p.000185: (3) improve the utilization of methods to incorporate the needs of children in planning for and
p.000185: responding to a public health emergency, including public awareness of such methods;
p.000185: (4) coordinate with, and improve, public-private partner- ships, such as health care coalitions
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p.000257: agricultural workers, the homeless, and residents of public housing, by pro- viding, either through the staff and
p.000257: supporting resources of the center or through contracts or cooperative arrangements—
p.000257: (A) required primary health services (as defined in subsection (b)(1)); and
p.000257: (B) as may be appropriate for particular centers, addi- tional health services (as defined in subsection (b)(2)) nec-
p.000257: essary for the adequate support of the primary health services required under subparagraph (A);
p.000257: for all residents of the area served by the center (hereafter re- ferred to in this section as the ‘‘catchment area’’).
p.000257: (2) LIMITATION.—The requirement in paragraph (1) to pro- vide services for all residents within a catchment
p.000257: area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i).
p.000257: (b) DEFINITIONS.—For purposes of this section:
p.000257: (1) REQUIRED PRIMARY HEALTH SERVICES.—
p.000257: (A) IN GENERAL.—The term ‘‘required primary health services’’ means—
p.000257: (i) basic health services which, for purposes of this section, shall consist of—
p.000257: (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology
p.000257: that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse
p.000257: midwives;
p.000257: (II) diagnostic laboratory and radiologic serv- ices;
p.000257: (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening;
p.000257: (cc) well-child services;
p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
p.000257: (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol;
p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
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p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
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p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
p.000265:
p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
p.000265: (B) such services will be continuous for each such re- cipient;
p.000265: (C) the center will provide follow-up services for indi- viduals who are referred by the center for
p.000265: services de- scribed in paragraph (1);
p.000265: (D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health
p.000265: services (including prenatal care) with respect to the pur- pose described in this subsection; and
p.000265: (E) the center will coordinate the provision of services with other maternal and child health providers
p.000265: operating in the catchment area.
p.000265: (g) MIGRATORY AND SEASONAL AGRICULTURAL WORKERS.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of—
p.000265: (A) migratory agricultural workers, seasonal agricul- tural workers, and members of the families of such migra-
p.000265: tory and seasonal agricultural workers who are within a designated catchment area; and
p.000265: (B) individuals who have previously been migratory agricultural workers but who no longer meet the
p.000265: require- ments of subparagraph (A) of paragraph (3) because of age or disability and members of the families of
p.000265: such individ- uals who are within such catchment area.
p.000265: (2) ENVIRONMENTAL CONCERNS.—The Secretary may enter into grants or contracts under this subsection with
p.000265: public and private entities to—
p.000265: (A) assist the States in the implementation and en- forcement of acceptable environmental health
p.000265: standards, including enforcement of standards for sanitation in mi- gratory agricultural worker and
p.000265: seasonal agricultural worker labor camps, and applicable Federal and State pes- ticide control standards; and
p.000265: (B) conduct projects and studies to assist the several States and entities which have received grants or
p.000265: contracts under this section in the assessment of problems related to camp and field sanitation, exposure to unsafe
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p.000287: (2) to carry out studies to identify—
p.000287: (A) the barriers to completion of the adoption process;
p.000287: and
p.000287: (B) those components that lead to favorable long-term
p.000287:
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p.000287: January 30, 2020
p.000287: outcomes for families that adopt children with special needs.
p.000287: (d) APPLICATION FOR GRANT.—The Secretary may make an award of a grant or contract under this section
p.000287: only if an applica- tion for the award is submitted to the Secretary and the applica-
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: PUBLIC HEALTH SERVICE ACT
p.000289: Sec. 330H
p.000289:
p.000289: tion is in such form, is made in such manner, and contains such agreements, assurances, and information
p.000289: as the Secretary deter- mines to be necessary to carry out this section.
p.000289: (e) FUNDING.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as
p.000289: may be nec- essary for each of the fiscal years 2001 through 2005.
p.000289: SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
p.000289: (a) IN GENERAL.—
p.000289: (1) CONTINUATION AND EXPANSION OF PROGRAM.—The Sec- retary, acting through the Administrator of the Health
p.000289: Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of
p.000289: this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent
p.000289: years, carry out such program on a national basis.
p.000289: (2) DEFINITION.—For purposes of paragraph (1), the term ‘‘Healthy Start Initiative’’ is a reference to
p.000289: the program that, as an initiative to reduce the rate of infant mortality and im- prove perinatal
p.000289: outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the ef-
p.000289: fective date of this section, was a demonstration program car- ried out under section 301.
p.000289: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000289: (1) REQUIREMENTS.—In making grants under subsection (a), the Secretary shall require that applicants (in
p.000289: addition to meeting all eligibility criteria established by the Secretary) es- tablish, for project areas under
p.000289: such subsection, community- based consortia of individuals and organizations (including agencies
p.000289: responsible for administering block grant programs under title V of the Social Security Act, consumers of
p.000289: project services, public health departments, hospitals, health centers under section 330, and other significant
p.000289: sources of health care services) that are appropriate for participation in projects under subsection (a).
p.000289: (2) OTHER CONSIDERATIONS.—In making grants under sub- section (a), the Secretary shall take into consideration
p.000289: the fol- lowing:
p.000289:
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p.000289: awarding grants under subsection (a) for special projects that are intended to address significant
p.000289: disparities in perinatal health indicators in communities along the United States-Mexico border or in Alas- ka or
p.000289: Hawaii.
p.000289: (c) COORDINATION.—Recipients of grants under subsection (a) shall coordinate their services and activities with
p.000289: the State agency
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: Sec. 330I PUBLIC HEALTH SERVICE ACT 290
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p.000289: January 30, 2020
p.000289:
p.000289: or agencies that administer block grant programs under title V of the Social Security Act in order to promote
p.000289: cooperation, integration, and dissemination of information with Statewide systems and with other community services
p.000289: funded under the Maternal and Child Health Block Grant.
p.000289: (d) RULE OF CONSTRUCTION.—Except to the extent inconsistent with this section, this section may not be construed as
p.000289: affecting the authority of the Secretary to make modifications in the program carried out under subsection
p.000289: (a).
p.000289: (e) FUNDING.—
p.000289: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000289: be appro- priated—
p.000289: (A) $120,000,000 for fiscal year 2008; and
p.000289: (B) for each of fiscal years 2009 through 2013, the amount authorized for the preceding fiscal year
p.000289: increased by the percentage increase in the Consumer Price Index for all urban consumers for such year.
p.000289: (2) ALLOCATION.—
p.000289: (A) PROGRAM ADMINISTRATION.—Of the amounts ap- propriated under paragraph (1) for a fiscal year, the Sec-
p.000289: retary may reserve up to 5 percent for coordination, dis- semination, technical assistance, and data
p.000289: activities that are determined by the Secretary to be appropriate for car- rying out the program under this section.
p.000289: (B) EVALUATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve
p.000289: up to 1 percent for evaluations of projects carried out under subsection (a). Each such evaluation shall
p.000289: include a determination of whether such projects have been effective in reducing the disparity in health status between
p.000289: the gen- eral population and individuals who are members of racial or ethnic minority groups.
p.000289: SEC. 330I. ø254c–14¿ TELEHEALTH NETWORK AND TELEHEALTH RE- SOURCE CENTERS GRANT PROGRAMS.
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p.000301: (A) be a statewide or regional network of pediatric mental health teams that provide support to pediatric pri-
p.000301: mary care sites as an integrated team;
p.000301: (B) support and further develop organized State or re- gional networks of pediatric mental health teams to pro-
p.000301: vide consultative support to pediatric primary care sites;
p.000301: (C) conduct an assessment of critical behavioral con- sultation needs among pediatric providers and such
p.000301: pro- viders’ preferred mechanisms for receiving consultation, training, and technical assistance;
p.000301: (D) develop an online database and communication mechanisms, including telehealth, to facilitate consultation
p.000301: support to pediatric practices;
p.000301: (E) provide rapid statewide or regional clinical tele- phone or telehealth consultations when requested between
p.000301: the pediatric mental health teams and pediatric primary care providers;
p.000301: (F) conduct training and provide technical assistance to pediatric primary care providers to support the
p.000301: early identification, diagnosis, treatment, and referral of chil- dren with behavioral health conditions;
p.000301: (G) provide information to pediatric providers about, and assist pediatric providers in accessing,
p.000301: pediatric men- tal health care providers, including child and adolescent psychiatrists, and licensed
p.000301: mental health professionals, such as psychologists, social workers, or mental health counselors and in
p.000301: scheduling and conducting technical as- sistance;
p.000301: (H) assist with referrals to specialty care and commu- nity or behavioral health resources; and
p.000301: (I) establish mechanisms for measuring and moni- toring increased access to pediatric mental health
p.000301: care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to
p.000301: identify, treat, and refer children with mental health problems.
p.000301: (2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, the term ‘‘pediatric mental health team’’ means a
p.000301: team con- sisting of at least one case coordinator, at least one child and adolescent psychiatrist, and at
p.000301: least one licensed clinical men- tal health professional, such as a psychologist, social worker, or mental
p.000301: health counselor. Such a team may be regionally based.
p.000301: (c) APPLICATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization seeking a
p.000301: grant under this section shall submit an application to the Secretary at such time, in such manner, and
p.000301: containing such information as the Secretary may re- quire, including a plan for the comprehensive evaluation
p.000301: of activi- ties that are carried out with funds received under such grant.
p.000301: (d) EVALUATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization that
p.000301: receives a grant under this section shall prepare and submit an evaluation of activities that are carried
p.000301: out with funds received under such grant to the Sec- retary at such time, in such manner, and containing such
p.000301: informa-
p.000301: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000301: Sec. 331 PUBLIC HEALTH SERVICE ACT 302
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p.000301: tion as the Secretary may reasonably require, including a process and outcome evaluation.
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p.000351: served the medically uninsured and underserved; and
p.000351: (2) submits to the Secretary an application, in such form and manner as the Secretary shall prescribe, that—
p.000351: (A) defines a community or geographic area of unin- sured and underinsured individuals;
p.000351: (B) identifies the providers who will participate in the consortium’s program under the grant, and specifies
p.000351: each provider’s contribution to the care of uninsured and under- insured individuals in the community, including
p.000351: the vol- ume of care the provider provides to beneficiaries under
p.000351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000351: Sec. 340 PUBLIC HEALTH SERVICE ACT 352
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p.000351: the medicare, medicaid, and State child health insurance programs and to patients who pay privately for
p.000351: services;
p.000351: (C) describes the activities that the applicant and the consortium propose to perform under the grant to
p.000351: further the objectives of this section;
p.000351: (D) demonstrates the consortium’s ability to build on the current system (as of the date of submission of the
p.000351: ap- plication) for serving a community or geographic area of uninsured and underinsured individuals by
p.000351: involving pro- viders who have traditionally provided a significant vol- ume of care for that community;
p.000351: (E) demonstrates the consortium’s ability to develop coordinated systems of care that either directly provide or
p.000351: ensure the prompt provision of a broad range of high-qual- ity, accessible services, including, as appropriate,
p.000351: primary, secondary, and tertiary services, as well as substance abuse treatment and mental health
p.000351: services in a manner that assures continuity of care in the community or geo- graphic area;
p.000351: (F) provides evidence of community involvement in the development, implementation, and direction of the pro- gram
p.000351: that the entity proposes to operate;
p.000351: (G) demonstrates the consortium’s ability to ensure that individuals participating in the program are
p.000351: enrolled in public insurance programs for which the individuals are eligible or know of private insurance
p.000351: programs where available;
p.000351: (H) presents a plan for leveraging other sources of rev- enue, which may include State and local sources and
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p.000487: (3) otherwise be in such form, be made in such manner, and contain such information and agreements as the
p.000487: Secretary determines to be necessary to carry out this subpart.
p.000487: (c) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary shall—
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p.000487: (1) provide for an evaluation of the activities for which an award is made under sections 398 or 398A; and
p.000487: (2) not later than 1 year after the completion of such eval- uations, submit to the Congress a report describing
p.000487: the find- ings made as a result of the evaluations.
p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: Sec. 399 PUBLIC HEALTH SERVICE ACT 488
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p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: January 30, 2020
p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
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p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: (4) FAMILY SERVICE PLAN.—A case manager, in consulta- tion with a team established in accordance with paragraph
p.000489: (5) for the family involved, shall develop a plan for the family fol- lowing the initial visit to the home of
p.000489: the family. Such plan shall reflect—
p.000489: (A) an assessment of the health and related social service needs of the family;
p.000489: (B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
p.000489: (C) the frequency with which such services are to be provided to the family;
p.000489: (D) ongoing revisions made as the needs of family members change; and
p.000489: (E) the continuing voluntary participation of the fam- ily in the plan.
p.000489: (5) HOME VISITING SERVICES TEAM.—The team to be con- sulted under paragraph (4) on behalf of a family shall
p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000489:
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p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
p.000491: drug treatment services, and the utilization of such services provided by the grantee; and
p.000491: (9) the incidence of developmental disabilities.
p.000491: (n) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under subsection (a) only if—
p.000491: (1) an application for the grant is submitted to the Sec- retary;
p.000491: (2) the application contains the agreements and assur- ances required in this section, and the information
p.000491: required in subsection (j);
p.000491: (3) the application contains evidence that the preparation of the application has been coordinated with the
p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
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p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
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p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
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p.000493: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000493: garding the provision of services to the public.
p.000493: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000493: the appli- cant involved agrees to make available (directly or through agree- ments with other entities) to
p.000493: children of substance abusers each of the following services:
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: PUBLIC HEALTH SERVICE ACT
p.000495: Sec. 399A
p.000495:
p.000495: (1) Periodic evaluation of children for developmental, psy- chological, and medical problems.
p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
p.000495: (4) Therapeutic intervention services for children, includ- ing provision of therapeutic child care.
p.000495: (5) Preventive counseling services.
p.000495: (6) Counseling related to the witnessing of chronic vio- lence.
p.000495: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000495: (A) education and special education programs;
p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000497: applicant involved agrees that the grant will not be expended—
p.000497: (1) to provide inpatient hospital services;
p.000497: (2) to make cash payments to intended recipients of serv- ices;
p.000497: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000497: build- ing or other facility, or purchase major medical equipment;
p.000497: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000497: of Federal funds; or
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p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
p.000497: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant involved
p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
p.000497: accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
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p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
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p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
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p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
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p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
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p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: PUBLIC HEALTH SERVICE ACT
p.000505: Sec. 399A
p.000505:
p.000505: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for health,
p.000505: including maternal and child health 95 mental health, child welfare, edu- cation, juvenile justice, developmental
p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
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p.000505: report
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p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
p.000507: Control, may make grants to States, or may make grants or enter into con- tracts with academic or
p.000507: nonprofit organizations designated by the State to operate the State’s cancer registry in lieu of mak- ing a grant
p.000507: directly to the State, to support the operation of population-based, statewide registries to collect, for each
p.000507: condi- tion specified in paragraph (2)(A), data concerning—
p.000507: (A) demographic information about each case of can-
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p.000507: cer;
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p.000511: New Hamp- shire, New Jersey, New York, Rhode Island, Vermont, and the Dis- trict of Columbia.
p.000511: (c) COOPERATION OF STATE.—The Secretary may conduct the study required in subsection (a) in a State only if the
p.000511: State agrees to cooperate with the Secretary in the conduct of the study, includ- ing providing information from
p.000511: any registry operated by the State pursuant to section 399B(a).
p.000511: (d) PLANNING, COMMENCEMENT, AND DURATION.—The Sec- retary shall, during each of the fiscal years 1993 and
p.000511: 1994, develop a plan for conducting the study required in subsection (a). The study shall be initiated by the
p.000511: Secretary not later than fiscal year 1994, and the collection of data under the study may continue through
p.000511: fiscal year 1998.
p.000511: SEC. 399E–1. ø280e–3a¿ NATIONAL CHILDHOOD CANCER REGISTRY.
p.000511: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.000511: awards to State cancer registries to enhance and expand infrastructure to collect information to better
p.000511: understand the epidemiology of cancer in children, adolescents, and young adults. Such registries may be
p.000511: updated to include each occurrence of such cancers within a period of time designated by the Secretary.
p.000511: (b) ACTIVITIES.—The grants described in subsection (a) may be used for—
p.000511: (1) identifying, recruiting, and training potential sources for reporting childhood, adolescent, and young
p.000511: adult cancer cases;
p.000511: (2) developing practices to ensure early inclusion of child- hood, adolescent, and young adult cancer cases in
p.000511: State cancer registries through the use of electronic reporting;
p.000511: (3) collecting and submitting deidentified data to the Cen- ters for Disease Control and Prevention for
p.000511: inclusion in a na- tional database that includes information on childhood, adoles- cent, and young adult cancers;
p.000511: and
p.000511: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000513: PUBLIC HEALTH SERVICE ACT
p.000513: Sec. 399G
p.000513:
p.000513: (4) improving State cancer registries and the database de- scribed in paragraph (3), as appropriate, including
p.000513: to support the early inclusion of childhood, adolescent, and young adult cancer cases.
p.000513: (c) COORDINATION.—To encourage the greatest possible effi- ciency and effectiveness of federally supported
p.000513: efforts with respect to the activities described in this section, the Secretary shall en- sure the
p.000513: appropriate coordination of programs supported under this section with other federally supported cancer registry
p.000513: programs and the activities under section 417E(a), as appropriate.
p.000513: (d) INFORMED CONSENT AND PRIVACY REQUIREMENTS AND CO- ORDINATION WITH EXISTING PROGRAMS.—The activities
p.000513: described in this section shall be subject to section 552a of title 5, United States Code, the regulations
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p.000521: 102 Enacted October 27, 1992.
p.000521:
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p.000521: Sec. 399H PUBLIC HEALTH SERVICE ACT 522
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p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
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p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.000523: technical assistance to eligible entities described in section 399I to carry out subsection (a).
p.000523: (c) DISSEMINATION OF CRITERIA.—In carrying out this section, the Secretary shall develop a procedure for
p.000523: disseminating the Fetal Alcohol Syndrome and Fetal Alcohol Effect diagnostic criteria de- veloped pursuant to
p.000523: section 705 of the ADAMHA Reorganization Act (42 U.S.C. 485n note) to health care providers, educators, social
p.000523: workers, child welfare workers, and other individuals.
p.000523: (d) NATIONAL TASK FORCE.—
p.000523: (1) IN GENERAL.—The Secretary shall establish a task force to be known as the National Task Force on Fetal Alcohol
p.000523: Syn- drome and Fetal Alcohol Effect (referred to in this subsection as the ‘‘Task Force’’) to foster
p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
...

p.000525: (3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a
p.000525: public or nonprofit private entity (including a State or political subdivision of a State), or a consortium
p.000525: of any of such entities.
p.000525: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—An el- igible entity shall identify in the plan submitted
p.000525: as part of an ap- plication for a grant under this section how the entity will coordi- nate operations
p.000525: and activities under the grant with—
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p.000525: January 30, 2020
p.000525: 103 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and paragraph
p.000525: (3) probably should be redesignated as paragraphs (3) and (4), respectively. See sec- tion 501 of Public Law 106–310
p.000525: (114 Stat. 1113).
p.000525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: Sec. 399L PUBLIC HEALTH SERVICE ACT 526
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p.000525: (1) other programs operated in the State that serve chil- dren with asthma, including any such
p.000525: programs operated under title V, XIX, or XXI of the Social Security Act; and
p.000525: (2) one or more of the following—
p.000525: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000525: such Act;
p.000525: (B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);
p.000525: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000525: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000525: (D) local public and private elementary or secondary schools; or
p.000525: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000525: U.S.C. 1437a).
p.000525: (c) EVALUATION.—An eligible entity that receives a grant under this section shall submit to the Secretary an evaluation
p.000525: of the oper- ations and activities carried out under the grant that includes—
p.000525: (1) a description of the health status outcomes of children assisted under the grant;
p.000525: (2) an assessment of the utilization of asthma-related health care services as a result of
p.000525: activities carried out under the grant;
p.000525: (3) the collection, analysis, and reporting of asthma data according to guidelines prescribed by the
p.000525: Director of the Cen- ters for Disease Control and Prevention; and
p.000525: (4) such other information as the Secretary may require.
p.000525: (d) PREFERENCE FOR STATES THAT ALLOW STUDENTS TO SELF- ADMINISTER MEDICATION TO TREAT ASTHMA AND
p.000525: ANAPHYLAXIS.—
p.000104: 104
p.000104: (1) PREFERENCE.—The Secretary, in making any grant under this section or any other grant that is
p.000104: asthma-related (as determined by the Secretary) to a State, shall give pref- erence to any State that
p.000104: satisfies the following:
p.000104: (A) IN GENERAL.—The State must require that each public elementary school and secondary school in that
p.000104: State will grant to any student in the school an authoriza- tion for the self-administration of medication to treat
...

p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
p.000527: INFANTS, AND YOUNG CHILDREN.
p.000527: (a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND
p.000527: SYS-
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: 529
p.000529: PUBLIC HEALTH SERVICE ACT
p.000529: Sec. 399M
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p.000529: January 30, 2020
p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
...

p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000529:
p.000529:
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p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
p.000529:
p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
p.000529: child hearing screening, evaluation (including audiologic, medical, and language acquisition
p.000529: evalua- tions), diagnosis, and intervention services;
p.000529: (ii) to conduct applied research related to new- born, infant, and young child hearing screening, eval-
p.000529: uation, and intervention programs and outcomes;
p.000529: (iii) to ensure quality monitoring of hearing screening, evaluation, and intervention programs and
p.000529: systems for newborns, infants, and young children; and
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p.000529: January 30, 2020
p.000529: (iv) to support newborn, infant, and young child hearing screening, evaluation, and intervention pro-
p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
p.000529: screening, evaluation, and intervention programs and systems;
p.000529: (iii) to collect data and report on newborn, infant, and young child hearing screening, evaluation, diag- nosis,
p.000529: and intervention programs and systems for ap- plied research, program evaluation, and policy im-
p.000529: provement;
p.000529: (iv) to identify the causes and risk factors for con- genital hearing loss;
p.000529: (v) to study the effectiveness of newborn, infant, and young child hearing screening, audiologic and
p.000529: medical evaluations and intervention programs and systems by assessing the health, intellectual and so-
p.000529: cial developmental, cognitive, and hearing status of these children at school age; and
p.000529: (vi) to promote the integration and interoper- ability of data regarding early hearing loss across mul-
p.000529: tiple sources to increase the flow of information be- tween clinical care and public health settings,
p.000529: includ- ing the ability of States and territories to exchange and share data.
p.000529: (2) NATIONAL INSTITUTES OF HEALTH.—The Director of the National Institutes of Health, acting through the
p.000529: Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
p.000529: this section, continue a pro- gram of research and development on the efficacy of new screening techniques
p.000529: and technology, including clinical studies of screening methods, studies on efficacy of intervention, and
p.000529: related research.
p.000529: (c) COORDINATION AND COLLABORATION.—
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: 531
p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
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p.000531: January 30, 2020
p.000531: (1) IN GENERAL.—In carrying out programs under this sec- tion, the Administrator of the Health Resources and
p.000531: Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the
p.000531: National Institutes of Health shall collaborate and consult with—
p.000531: (A) other Federal agencies;
p.000531: (B) State and local agencies, including agencies re- sponsible for early intervention services pursuant to
p.000531: title XIX of the Social Security Act (Medicaid Early and Peri- odic Screening, Diagnosis and Treatment
p.000531: Program); title XXI of the Social Security Act (State Children’s Health In- surance Program); title V of the
p.000531: Social Security Act (Ma- ternal and Child Health Block Grant Program); and part C of the Individuals with
p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
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p.000531: January 30, 2020
p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
p.000531: of this subsection), by striking ‘‘(3)’’ and all that follows through ‘‘decision making’’ and inserting
p.000531: ‘‘The term ‘medical evaluation’ means key components performed by a physician including history,
p.000531: examination, and medical decisionmaking’’’. Based on the structure of this provision of defined terms, the
p.000531: paragraph (3) enumerator was likely mistakenly left out of the inserted matter. It was re-inserted to reflect
p.000531: the probable intent of Congress.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: 533
p.000533: PUBLIC HEALTH SERVICE ACT
p.000533: Sec. 399N
p.000533:
p.000533: (1) STATEWIDE NEWBORN AND INFANT HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—For
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p.000533: outcomes among children with childhood cancers and resultant secondary conditions, including limb loss, anemia,
p.000533: rehabilitation, and palliative care. Such projects shall be carried out by the Secretary directly and
p.000533: through awards of grants or contracts.
p.000533: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) in- clude—
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p.000533: (1) the expansion of current demographic data collection and population surveillance efforts to include
p.000533: childhood cancers nationally;
p.000533: (2) the development of a uniform reporting system under which treating physicians, hospitals, clinics, and
p.000533: States report the diagnosis of childhood cancers, including relevant associ- ated epidemiological data; and
p.000533: (3) support for the National Limb Loss Information Center to address, in part, the primary and secondary needs
p.000533: of per- sons who experience childhood cancers in order to prevent or minimize the disabling nature of these
p.000533: cancers.
p.000533: (c) COORDINATION OF ACTIVITIES.—The Secretary shall assure that activities under this section are
p.000533: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities focused on
p.000533: childhood cancers and limb loss.
p.000533: (d) DEFINITION.—For purposes of this section, the term ‘‘child- hood cancer’’ refers to a spectrum of
p.000533: different malignancies that
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: Sec. 399O PUBLIC HEALTH SERVICE ACT 534
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p.000533: vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this
p.000533: section revise the definition of such term to the extent determined by the Secretary to be appro-
p.000533: priate.
p.000533: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000533: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000533: SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
p.000533: (a) PROGRAM.—
p.000533: (1) IN GENERAL.—Each fiscal year, the Secretary, acting through the Director of the Centers for Disease
p.000533: Control and Prevention, in coordination with the heads of other depart- ments and agencies as appropriate,
p.000533: shall support States or lo- calities for the purpose of improving the efficiency and use of PDMPs, including—
p.000533: (A) establishment and implementation of a PDMP;
p.000533: (B) maintenance of a PDMP;
p.000533: (C) improvements to a PDMP by—
p.000533: (i) enhancing functional components to work to- ward—
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p.000539: dress domestic violence, dating violence, sexual as- sault, and stalking, or by contracting with or
p.000539: hiring domestic or sexual assault advocates to provide such services or to model other services
p.000539: appropriate to the geographic and cultural needs of a site;
p.000539: (iii) the development of measures and methods for the evaluation of the practice of identification, inter-
p.000539: vention, and documentation regarding victims of do- mestic violence, dating violence, sexual assault, and
p.000539: stalking, including the development and testing of quality improvement measurements, in accordance
p.000539: with the multi-stakeholder and quality measurement processes established under paragraphs (7) and (8) of
p.000539: section 1890(b) and section 1890A of the Social Secu- rity Act (42 U.S.C. 1395aaa(b)(7) and (8); 42
p.000539: U.S.C. 1890A); and
p.000539: (iv) the provision of training and follow-up tech- nical assistance to health care professionals, and pub- lic
p.000539: health staff, and allied health professionals to iden- tify, assess, treat, and refer clients who are victims of
p.000539: domestic violence, dating violence, sexual assault, or stalking, including using tools and training
p.000539: materials already developed.
p.000539: (2) PERMISSIBLE USES.—
p.000539: (A) CHILD AND ELDER ABUSE.—To the extent consistent with the purpose of this section, a grantee may
p.000539: use amounts received under this section to address, as part of a comprehensive programmatic approach
p.000539: implemented under the grant, issues relating to child or elder abuse.
p.000539: (B) RURAL AREAS.—Grants funded under paragraphs
p.000539: (1) and (2) of subsection (a) may be used to offer to rural areas community-based training
p.000539: opportunities, which may include the use of distance learning networks and other available technologies
p.000539: needed to reach isolated rural areas, for medical, nursing, and other health profession students and residents on
p.000539: domestic violence, dating violence, sexual assault, stalking, and, as appropriate, other forms of vio- lence
p.000539: and abuse.
p.000539: (C) OTHER USES.—Grants funded under subsection (a)(3) may be used for—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: PUBLIC HEALTH SERVICE ACT
p.000541: Sec. 399P
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p.000541: January 30, 2020
p.000541: (i) the development of training modules and poli- cies that address the overlap of child abuse, domestic
p.000541: violence, dating violence, sexual assault, and stalking and elder abuse, as well as childhood exposure to
p.000541: do- mestic and sexual violence;
p.000541: (ii) the development, expansion, and implementa- tion of sexual assault forensic medical examination or sexual
p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
...

p.000570:
p.000570:
p.000570:
p.000570:
p.000570: January 30, 2020
p.000570: SEC. 399W. ø280h¿ GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL ACTIVITY.
p.000570: (a) IN GENERAL.—The Secretary, acting though the Director of the Centers for Disease Control and Prevention,
p.000570: shall award com- petitive grants to States and political subdivisions of States for the development and
p.000570: implementation of State and community-based intervention programs to promote good nutrition and physical
p.000570: ac- tivity in children and adolescents.
p.000570: (b) ELIGIBILITY.—To be eligible to receive a grant under this section a State or political subdivision of a
p.000570: State shall prepare and submit to the Secretary an application at such time, in such man- ner, and containing such
p.000570: information as the Secretary may require, including a plan that describes—
p.000570: (1) how the applicant proposes to develop a comprehensive program of school- and community-based approaches to encour-
p.000570: age and promote good nutrition and appropriate levels of phys- ical activity with respect to children or
p.000570: adolescents in local communities;
p.000570: (2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as
p.000570: State and local school departments, State departments of health, chronic disease directors, State directors of programs
p.000570: under section 17 of the Child Nutrition Act of 1966, 5-a-day coordinators, gov- ernors councils for
p.000570: physical activity and good nutrition, and State and local parks and recreation departments; and
p.000570: (3) the manner in which the applicant will evaluate the ef- fectiveness of the program carried out under this section.
p.000570: (c) USE OF FUNDS.—A State or political subdivision of a State shall use amount received under a grant under
p.000570: this section to—
p.000570: (1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to
p.000570: reduce inactivity and improve dietary choices among children and adolescents;
p.000570: (2) expand opportunities for physical activity programs in school- and community-based settings; and
p.000570: (3) develop, implement, and evaluate programs that pro- mote good eating habits and physical activity including
p.000570: oppor- tunities for children with cognitive and physical disabilities.
p.000570: (d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an amount not to exceed 10 percent of the amount
p.000570: appropriated for a fiscal year under subsection (h) to permit the Director of the Cen- ters for Disease
p.000570: Control and Prevention to—
p.000570: (1) provide States and political subdivisions of States with technical support in the development and
p.000570: implementation of programs under this section; and
...

p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
p.000571: (4) conduct research to establish the prevalence, con- sequences, and costs of childhood obesity
p.000571: and its effects in adulthood;
p.000571: (5) identify behaviors and risk factors that contribute to obesity;
p.000571: (6) evaluate materials and programs to provide nutrition education to parents and teachers of children in
p.000571: child care or pre-school and the food service staff of such child care and pre- school entities; and
p.000571: (7) evaluate materials and programs that are designed to educate and encourage physical activity in child
p.000571: care and pre- school facilities.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Y. ø280h–2¿ EDUCATION CAMPAIGN.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000571: and in collabora- tion with national, State, and local partners, physical activity orga- nizations, nutrition
p.000571: experts, and health professional organizations, shall develop a national public campaign to promote and
p.000571: educate children and their parents concerning—
p.000571: (1) the health risks associated with obesity, inactivity, and poor nutrition;
p.000571: (2) ways in which to incorporate physical activity into daily living; and
p.000571: (3) the benefits of good nutrition and strategies to improve eating habits.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571:
p.000571: January 30, 2020 As Amended Through P.L. 116-94,
p.000571: Enacted December 20, 2019
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p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000575: Sec. 399Z–2 PUBLIC HEALTH SERVICE ACT 576
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p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
p.000575: (A) is at risk for, shows early signs of, or has been di- agnosed with a mental illness, including a serious
p.000575: emo- tional disturbance; and
p.000575: (B) may benefit from infant and early childhood inter- vention or treatment programs or specialized preschool or
p.000575: elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise
p.000575: but would benefit from further applied development.
p.000575: (2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a human services agency or nonprofit institution that—
p.000575: (A) employs licensed mental health professionals who have specialized training and experience in infant
p.000575: and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the
p.000575: appropriate State agency, as applicable, to provide for children from in- fancy to 12 years of age mental health
p.000575: promotion, inter- vention, or treatment services; and
p.000575: (B) provides services or programs described in sub- section (a) that are evidence-based or that have
p.000575: been sci- entifically demonstrated to show promise but would benefit from further applied development.
p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
...

p.000579: disorder and other developmental disabilities as early as practicable.
p.000579: (c) INFORMATION AND EDUCATION.—
p.000579: (1) IN GENERAL.—In carrying out subsection (b)(1), the Sec- retary, in collaboration with the Secretary of
p.000579: Education and the Secretary of Agriculture, shall, subject to the availability of appropriations, provide culturally
p.000579: competent information re- garding autism spectrum disorder and other developmental disabilities, risk
p.000579: factors, characteristics, identification, diag- nosis or rule out, and evidence-based interventions to meet the
p.000579: needs of individuals with autism spectrum disorder and other
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: Sec. 399BB PUBLIC HEALTH SERVICE ACT 580
p.000579:
p.000579: developmental disabilities across their lifespan and the needs of their families through—
p.000579: (A) Federal programs, including—
p.000579: (i) the Head Start program;
p.000579: (ii) the Early Start program;
p.000579: (iii) the Healthy Start program;
p.000579: (iv) programs under the Child Care and Develop- ment Block Grant Act of 1990;
p.000579: (v) programs under title XIX of the Social Security Act (particularly the Medicaid Early and Periodic
p.000579: Screening, Diagnosis and Treatment Program);
p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
p.000579: autism spectrum disorder or other developmental dis- abilities), and evidence-based interventions.
p.000579: (B) REQUIREMENTS OF AGENCY.—In designating the lead agency under subparagraph (A)(i), the Governor
p.000579: shall—
p.000579:
p.000579:
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p.000579: January 30, 2020
p.000579: (i) select an agency that has demonstrated experi- ence and expertise in—
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: Security Act, shall, subject to the availability of appropriations, expand existing
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: Sec. 399BB PUBLIC HEALTH SERVICE ACT 582
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p.000581:
p.000581: interdisciplinary training opportunities or opportunities to in- crease the number of sites able to diagnose or
p.000581: rule out individ- uals with autism spectrum disorder or other developmental disabilities across their lifespan
p.000581: and ensure that—
p.000581: (A) competitive grants or cooperative agreements are awarded to public or nonprofit agencies, including
p.000581: institu- tions of higher education, to expand existing or develop new maternal and child health
p.000581: interdisciplinary leadership education in neurodevelopmental and related disabilities programs (similar to the
p.000581: programs developed under section 501(a)(2) of the Social Security Act) in States that do not have such a
p.000581: program;
p.000581: (B) trainees under such training programs—
p.000581: (i) receive an appropriate balance of academic, clinical, and community opportunities;
p.000581: (ii) are culturally competent;
p.000581: (iii) are ethnically diverse;
p.000581: (iv) demonstrate a capacity to evaluate, diagnose or rule out, develop, and provide evidence-based inter-
p.000581: ventions to individuals with autism spectrum disorder and other developmental disabilities across their life-
p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
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p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: Sec. 401 PUBLIC HEALTH SERVICE ACT 598
p.000597:
p.000597: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out sub- sections (a), (b), (c)(1), and (d), there are
p.000597: authorized to be appro- priated $4,900,000 for each of fiscal years 2015 through 2019.
p.000597: TITLE IV—NATIONAL RESEARCH INSTITUTES PART A—NATIONAL INSTITUTES OF HEALTH
p.000597: SEC. 401. ø281¿ ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
p.000597: (a) RELATION TO PUBLIC HEALTH SERVICE.—The National Insti- tutes of Health is an agency of the Service. 1
p.000597: (b) NATIONAL RESEARCH INSTITUTES AND NATIONAL CENTERS.— The following agencies of the National Institutes of
p.000597: Health are na- tional research institutes or national centers:
p.000597: (1) The National Cancer Institute.
p.000597: (2) The National Heart, Lung, and Blood Institute.
p.000597: (3) The National Institute of Diabetes and Digestive and Kidney Diseases.
p.000597: (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
p.000597: (9) The National Eye Institute.
p.000597: (10) The National Institute of Neurological Disorders and Stroke.
p.000597: (11) The National Institute on Deafness and Other Com- munication Disorders.
p.000597: (12) The National Institute on Alcohol Abuse and Alco- holism.
p.000597: (13) The National Institute on Drug Abuse.
p.000597: (14) The National Institute of Mental Health.
p.000597: (15) The National Institute of General Medical Sciences.
p.000597: (16) The National Institute of Environmental Health Sciences.
p.000597: (17) The National Institute of Nursing Research.
p.000597: (18) The National Institute of Biomedical Imaging and Bio- engineering.
p.000597: (19) The National Human Genome Research Institute.
p.000597: (20) The National Library of Medicine.
p.000597: (21) The National Center for Advancing Translational Sciences.
p.000597: (22) The John E. Fogarty International Center for Ad- vanced Study in the Health Sciences.
p.000597:
p.000597:
p.000597:
p.000597:
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p.000597:
p.000597:
p.000597: January 30, 2020
p.000597: 1 See footnote for section 202.
p.000597: 2 Section 212 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000597: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–359)
p.000597: amended subparagraph (H) to read as provided above, there- by indicating the intent of the Congress to change the
...

p.000637: SEC. 404A. 6 ø283c¿ (a) There is established within the Office of the Director of NIH an office to be known
p.000637: as the Office of Behav- ioral and Social Sciences Research (in this section referred to as the ‘‘Office’’).
p.000637: The Office shall be headed by a director, who shall be appointed by the Director of NIH.
p.000637: (b)(1) With respect to research on the relationship between human behavior and the development, treatment,
p.000637: and prevention of medical conditions, the Director of the Office shall—
p.000637: (A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
p.000637: (B) identify projects of behavioral and social sciences re- search that should be conducted or supported
p.000637: by the national research institutes, and develop such projects in cooperation with such institutes.
p.000637: (2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent
p.000637: behavior, suicide, and homelessness. Such research does not include neurobiological re- search, or research
p.000637: in which the behavior of an organism is ob- served for the purpose of determining activity at the cellular or
p.000637: mo- lecular level.
p.000637: CHILDREN’S VACCINE INITIATIVE
p.000637: SEC. 404B. ø283d¿
p.000637: The Secretary, in consultation with the Director of the Na- tional Vaccine Program under title XXI and acting
p.000637: through the Di- rectors of the National Institute for Allergy and Infectious Dis- eases, the Eunice Kennedy
p.000637: Shriver National Institute of Child Health and Human Development, the National Institute for Aging, and other
p.000637: public and private programs, shall carry out activities, which shall be consistent with the global Children’s
p.000637: Vaccine Initia- tive, to develop affordable new and improved vaccines to be used in the United States and in
p.000637: the developing world that will increase
p.000637:
p.000637:
p.000637:
p.000637: January 30, 2020
p.000637: 6 Section 404 was struck by section 101(b)(2) of Public Law 106–525 (114 Stat. 2501).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000637:
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p.000639: 639
p.000639: PUBLIC HEALTH SERVICE ACT
p.000639: Sec. 404C
p.000639:
p.000639: the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities,
p.000639: the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to
p.000639: deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and
p.000639: syringes, and that protect against a larger number of diseases.
p.000639: PLAN FOR USE OF ANIMALS IN RESEARCH
p.000639: SEC. 404C. ø283e¿ (a) The Director of NIH, after consultation with the committee established under subsection
...

p.000639: through the Na- tional Institutes of Health, the survey may not be carried out un- less—
p.000639:
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p.000639: (1) the proposal has undergone review in accordance with any applicable requirements of sections 491 and 492;
p.000639: and
p.000639: (2) the Secretary, in accordance with section 492A, makes a determination that the information expected
p.000639: to be obtained through the survey will assist—
p.000639: (A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human
p.000639: im- munodeficiency virus, or the incidence of any other infec- tious disease; or
p.000639: (B) in improving reproductive health or other condi- tions of health.
p.000639: SEC. 404E. ø283g¿ MUSCULAR DYSTROPHY; INITIATIVE THROUGH DI- RECTOR OF NATIONAL INSTITUTES OF HEALTH.
p.000639: (a) EXPANSION, INTENSIFICATION, AND COORDINATION OF AC-
p.000639: TIVITIES.—
p.000639: (1) IN GENERAL.—The Director of NIH, in coordination with the Directors of the National Institute of
p.000639: Neurological Disorders and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases,
p.000639: the Eunice Kennedy Shriv- er National Institute of Child Health and Human Develop- ment, the National Heart,
p.000639: Lung, and Blood Institute, and the other national research institutes as appropriate, shall expand and intensify
p.000639: programs of such Institutes with respect to re- search and related activities concerning various forms
p.000639: of mus- cular dystrophy, including Duchenne, Becker, congenital mus- cular dystrophy, limb-girdle muscular
p.000639: dystrophy, myotonic, facioscapulohumeral muscular dystrophy (referred to in this section as ‘‘FSHD’’) and
p.000639: other forms of muscular dystrophy.
p.000639: (2) COORDINATION.—The Directors referred to in paragraph
p.000639: (1) shall jointly coordinate the programs referred to in such paragraph and consult with the Muscular
p.000639: Dystrophy Inter- agency Coordinating Committee established under section 6 of the MD–CARE Act.
p.000639: (3) ALLOCATIONS BY DIRECTOR OF NIH.—The Director of NIH shall allocate the amounts appropriated to
p.000639: carry out this section for each fiscal year among the national research insti- tutes referred to in
p.000639: paragraph (1).
p.000639: (b) CENTERS OF EXCELLENCE.—
p.000639: (1) IN GENERAL.—The Director of NIH shall award grants and contracts under subsection (a)(1) to public or
p.000639: nonprofit pri- vate entities to pay all or part of the cost of planning, estab-
p.000639: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000639:
p.000639:
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p.000641: 641
p.000641: PUBLIC HEALTH SERVICE ACT
p.000641: Sec. 404E
p.000641:
p.000641:
p.000641:
p.000641:
...

p.000667: such programs and activities.
p.000667: PEDIATRIC RESEARCH INITIATIVE
p.000667: SEC. 409D. ø284h¿ (a) ESTABLISHMENT.—The Secretary shall establish within the Office of the Director of
p.000667: NIH a Pediatric Re- search Initiative (referred to in this section as the ‘‘Initiative’’) to conduct and
p.000667: support research that is directly related to diseases, disorders, and other conditions in children. The
p.000667: Initiative shall be headed by the Director of NIH.
p.000667: (b) PURPOSE.—The purpose of the Initiative is to provide funds to enable the Director of NIH—
p.000667: (1) to increase support for pediatric biomedical research within the National Institutes of Health to realize
p.000667: the expand- ing opportunities for advancement in scientific investigations and care for children;
p.000667: (2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in
p.000667: the areas that the Director deems most promising; and
p.000667: (3) in coordination with the Food and Drug Administra- tion, to increase the development of adequate pediatric
p.000667: clinical trials and pediatric use information to promote the safer and more effective use of prescription
p.000667: drugs in the pediatric popu- lation.
p.000667: (c) DUTIES.—In carrying out subsection (b), the Director of NIH shall—
p.000667: (1) consult with the Director of the Eunice Kennedy Shriv-
p.000667: er National Institute of Child Health and Human Development and the other national research institutes, in considering
p.000667: their requests for new or expanded pediatric research efforts, and consult with the Administrator of the
p.000667: Health Resources and Services Administration and other advisors as the Director de- termines to be appropriate;
p.000667: (2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of
p.000667: grants, and between basic and clinical research so long as the assistance is directly related to the
p.000667: illnesses and conditions of children; and
p.000667:
p.000667:
p.000667:
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p.000667:
p.000667:
p.000667: January 30, 2020
p.000667: (3) be responsible for the oversight of any newly appro- priated Initiative funds and annually report to
p.000667: Congress and the public on the extent of the total funds obligated to conduct or support pediatric research
p.000667: across the National Institutes of Health, including the specific support and research awards al- located through
p.000667: the Initiative.
p.000667: (d) NATIONAL PEDIATRIC RESEARCH NETWORK.—
p.000667: (1) NETWORK.—In carrying out the Initiative, the Director of NIH, in collaboration with the national
p.000667: research institutes and national centers that carry out activities involving pedi- atric research, shall
p.000667: support a National Pediatric Research Network in order to more effectively support pediatric research
p.000667: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000667:
p.000667:
p.000667:
p.000667:
p.000667:
p.000667:
...

p.000689: young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—
p.000689: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000689:
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p.000691: 691
p.000691: PUBLIC HEALTH SERVICE ACT
p.000691: Sec. 417E
p.000691:
p.000691:
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p.000691: January 30, 2020
p.000691: (i) consistent with the procedures established pur- suant to subparagraph (C);
p.000691: (ii) only to the extent permitted by applicable Fed- eral and State law; and
p.000691: (iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy
p.000691: law, at minimum.
p.000691: (3) NO REQUIREMENT.—No child, adolescent, or young adult with cancer shall be required under this
p.000691: subsection to contribute a specimen to a biorepository or share clinical or de- mographic data.
p.000691: (4) APPLICATION; CONSIDERATIONS.—
p.000691: (A) APPLICATION.—To be eligible to receive an award under paragraph (1) an entity shall submit an application to
p.000691: the Secretary at such a time, in such manner, and con- taining such information as the Secretary may reasonably
p.000691: require.
p.000691: (B) CONSIDERATIONS.—In evaluating applications sub- mitted under subparagraph (A), the Secretary shall con-
p.000691: sider the existing infrastructure of the entity that would allow for the timely capture of biospecimens
p.000691: and related clinical and demographic information for children, adoles- cents, and young adults with cancer
p.000691: for whom current treatments are least effective.
p.000691: (5) PRIVACY PROTECTIONS AND INFORMED CONSENT.—
p.000691: (A) IN GENERAL.—The Secretary may not make an award under paragraph (1) to an entity unless the Sec-
p.000691: retary ensures that such entity—
p.000691: (i) collects biospecimens and associated clinical and demographic information only from participants who
p.000691: have given their informed consent in accordance with Federal and State law; and
p.000691: (ii) protects personal privacy to the extent re- quired by applicable Federal and State law, at min-
p.000691: imum.
...

p.000703:
p.000703: (c)(1) The Director of the National Institutes of Health shall es- tablish a board to be known as the Sleep Disorders
p.000703: Research Advi- sory Board (in this section referred to as the ‘‘Advisory Board’’).
p.000703: (2) The Advisory Board shall advise, assist, consult with, and make recommendations to the Director of
p.000703: the National Institutes of Health, through the Director of the Institute, and the Director of the Center
p.000703: concerning matters relating to the scientific activities carried out by and through the Center and the
p.000703: policies respecting such activities, including recommendations with respect to the plan required in subsection (c) 20.
p.000703: (3)(A) The Director of the National Institutes of Health shall appoint to the Advisory Board 12 appropriately
p.000703: qualified represent- atives of the public who are not officers or employees of the Federal Government. Of such
p.000703: members, eight shall be representatives of health and scientific disciplines with respect to sleep disorders and
p.000703: four shall be individuals representing the interests of individuals with or undergoing treatment for sleep
p.000703: disorders.
p.000703: (B) The following officials shall serve as ex officio members of the Advisory Board:
p.000703: (i) The Director of the National Institutes of Health.
p.000703: (ii) The Director of the Center.
p.000703: (iii) The Director of the National Heart, Lung and Blood Institute.
p.000703: (iv) The Director of the National Institute of Mental Health.
p.000703: (v) The Director of the National Institute on Aging.
p.000703: (vi) The Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000703: (vii) The Director of the National Institute of Neurological Disorders and Stroke.
p.000703: (viii) The Assistant Secretary for Health.
p.000703: (ix) The Assistant Secretary of Defense (Health Affairs).
p.000703: (x) The Chief Medical Director of the Veterans’ Adminis- tration.
p.000703: (4) The members of the Advisory Board shall, from among the members of the Advisory Board, designate an
p.000703: individual to serve as the chair of the Advisory Board.
p.000703: (5) Except as inconsistent with, or inapplicable to, this section, the provisions of section 406 shall apply to the
p.000703: advisory board 21 es- tablished under this section in the same manner as such provisions apply to any advisory council
p.000703: established under such section.
p.000703: (d)(1) After consultation with the Director of the Center and the advisory board established under subsection
p.000703: (c), the Director of the National Institutes of Health shall develop a comprehensive plan for the conduct and
p.000703: support of sleep disorders research.
p.000703: (2) The plan developed under paragraph (1) shall identify pri- orities with respect to such research and
p.000703: shall provide for the co- ordination of such research conducted or supported by the agencies of the National
p.000703: Institutes of Health.
p.000703:
p.000703:
p.000703:
p.000703:
p.000703:
p.000703: January 30, 2020
p.000703: 20 So in law. See section 503 of Public Law 103–43 (107 Stat. 159). Probably should be ‘‘sub- section
p.000703: (d)’’.
p.000703: 21 So in law. See section 503 of Public Law 103–43 (107 Stat. 159). Probably should be capital- ized.
p.000703: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000703:
p.000703:
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p.000709:
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p.000709: January 30, 2020
p.000709:
p.000709: cation, nursing, data systems, public information, and commu- nity program development.
p.000709: (2)(A) The following shall be ex officio members of each Ad- visory Board:
p.000709: (i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and
p.000709: Digestive and Kidney Diseases, the Director of the Centers for Disease Control and Prevention, the Chief Medical Di-
p.000709: rector of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, and the
p.000709: Division Director of the National Institute of Diabetes and Diges- tive and Kidney Diseases for the
p.000709: diseases for which the Board is established (or the designees of such officers).
p.000709: (ii) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000709: sory Board to carry out its functions.
p.000709: (B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio
p.000709: members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute,
p.000709: the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Devel- opment, and
p.000709: the Administrator of the Health Resources and Services Administration (or the designees of such officers).
p.000709: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000709: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000709: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000709: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000709: engaged in the per- formance of their duties as members of the Board.
p.000709: (d) The term of office of an appointed member of an Advisory Board is four years, except that no term
p.000709: of office may extend be- yond the expiration of the Advisory Board. Any member appointed to fill a vacancy for
p.000709: an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of
p.000709: the member’s term until a successor has taken office. If a va- cancy occurs in an Advisory Board, the
p.000709: Secretary shall make an ap- pointment to fill the vacancy not later than 90 days from the date the vacancy occurred.
p.000709: (e) The members of each Advisory Board shall select a chair- man from among the appointed members.
p.000709: (f) The Secretary shall, after consultation with and consider- ation of the recommendations of an
p.000709: Advisory Board, provide the Advisory Board with an executive director and one other profes- sional staff
p.000709: member. In addition, the Secretary shall, after con- sultation with and consideration of the recommendations of
...

p.000711:
p.000713: 713
p.000713: PUBLIC HEALTH SERVICE ACT
p.000713: Sec. 432
p.000713:
p.000713: such patients, physicians and others who care for such pa- tients, and the general public;
p.000713: (B) model programs for cost effective and preventive patient care; and
p.000713: (C) training physicians and scientists in research on such diseases; and
p.000713: (4) may perform research and participate in epidemiolog- ical studies and data collection relevant to kidney and
p.000713: urologic diseases in order to disseminate such research, studies, and data to the health care profession and to
p.000713: the public.
p.000713: (d)(1) The Director of the Institute shall, subject to the extent of amounts made available in
p.000713: appropriations Acts, provide for the development or substantial expansion of centers for research and
p.000713: training regarding nutritional disorders, including obesity.
p.000713: (2) The Director of the Institute shall carry out paragraph (1) in collaboration with the Director of the
p.000713: National Cancer Institute and with the Directors of such other agencies of the National Insti- tutes of Health as
p.000713: the Director of NIH determines to be appro- priate.
p.000713: (3) Each center developed or expanded under paragraph (1) shall—
p.000713: (A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting
p.000713: such re- search and training qualifications as may be prescribed by the Director;
p.000713: (B) conduct basic and clinical research into the cause, diag- nosis, early detection, prevention, control and treatment
p.000713: of nu- tritional disorders, including obesity and the impact of nutri- tion and diet on child development;
p.000713: (C) conduct training programs for physicians and allied health professionals in current methods of diagnosis and
p.000713: treat- ment of such diseases and complications, and in research in such disorders; and
p.000713: (D) conduct information programs for physicians and allied health professionals who provide primary care for
p.000713: patients with such disorders or complications.
p.000713: (e) Insofar as practicable, centers developed or expanded under this section should be geographically dispersed
p.000713: throughout the United States and in environments with proven research capabili- ties. Support of a center
p.000713: under this section may be for a period of not to exceed five years and such period may be extended
p.000713: by the Director of the Institute for additional periods of not more than five years each if the operations of
p.000713: such center have been reviewed by an appropriate technical and scientific peer review group estab- lished
p.000713: by the Director and if such group has recommended to the Director that such period should be extended.
p.000713:
p.000713:
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p.000713:
p.000713:
p.000713:
p.000713: January 30, 2020
p.000713:
p.000713: ADVISORY COUNCIL SUBCOMMITTEES
p.000713: SEC. 432. ø285c–6¿ There are established within the advisory council for the Institute appointed under
p.000713: section 406 a sub- committee on diabetes and endocrine and metabolic diseases, a subcommittee on
p.000713: digestive diseases and nutrition, and a sub- committee on kidney, urologic, and hematologic diseases.
p.000713: The sub-
p.000713: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000713:
p.000713:
p.000713:
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p.000729: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000729: treatment of individuals with sexually transmitted diseases.
p.000729: (b) SUPPORT OF PROMISING CLINICIANS.—In order to foster the application of the most current developments in the
p.000729: etiology, patho- genesis, diagnosis, prevention and treatment of sexually trans- mitted diseases, amounts
p.000729: made available under this section shall be directed to the support of promising clinicians through awards
p.000729: for research, study, and practice at centers of excellence in sexually transmitted disease research and treatment.
p.000729: (c) EXCELLENCE IN CERTAIN FIELDS.—Research shall be carried out under awards made under subsection (b) in
p.000729: environments of demonstrated excellence in the etiology and pathogenesis of sexu- ally transmitted diseases
p.000729: and shall foster innovation and integra- tion of such disciplines or other environments determined
p.000729: suitable by the Director of the Institute.
p.000729: SEC. 447C. ø285f–4¿ MICROBICIDE RESEARCH AND DEVELOPMENT.
p.000729: The Director of the Institute, acting through the head of the Division of AIDS, shall, consistent with
p.000729: the peer-review process of the National Institutes of Health, carry out research on, and devel- opment of, safe and
p.000729: effective methods for use by women to prevent the transmission of the human immunodeficiency virus, which may include
p.000729: microbicides.
p.000729: Subpart 7—Eunice Kennedy Shriver National Institute of Child Health and Human Development 31
p.000729: PURPOSE OF THE INSTITUTE
p.000729: SEC. 448. ø285g¿ The general purpose of the National Institute of Child Health and Human Development 32 (hereafter in
p.000729: this sub- part referred to as the ‘‘Institute’’) is the conduct and support of re- search, training, health
p.000729: information dissemination, and other pro- grams with respect to gynecologic health, maternal health, child
p.000729: health, intellectual disabilities, human growth and development,
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729: January 30, 2020
p.000729: 31 Section 1004 of Public Law 106–310 (114 Stat. 1130) authorizes the Director of the Institute to conduct a national
p.000729: longitudinal study of environmental influences (including physical, chem- ical, biological, and psychosocial) on
p.000729: children’s health and development. Subsection (d) of such section requires periodic reports to the Congress
p.000729: regarding the study. The first report is required to be submitted not later than three years after the date
p.000729: of the enactment of the Public Law, which was enacted October 17, 2000.
p.000729: 32 The probable intent of the Congress is to refer to the ‘‘Eunice Kennedy Shriver National Institute of
p.000729: Child Health and Human Development’’. Section 1(b)(7) of Public Law 110–154 (121 Stat 1827) struck the term
p.000729: ‘‘National Institute of Child Health and Human Development’’ and inserted ‘‘Eunice Kennedy Shriver National
p.000729: Institute of Child Health and Human Development’’ each place such term appeared in the heading of subpart 7 of part C
p.000729: of title IV, but not in the text of section 448.
p.000729: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000729:
p.000729:
p.000729:
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p.000729: Sec. 449 PUBLIC HEALTH SERVICE ACT 730
p.000729:
p.000729: including prenatal development, population research, and special health problems and requirements of mothers and
p.000729: children.
p.000729: SUDDEN INFANT DEATH SYNDROME
p.000729: SEC. 449. ø285g–1¿ The Director of the Institute shall conduct and support research which specifically relates to
p.000729: sudden infant death syndrome.
p.000729: SEC. 450. ø285g–2¿ RESEARCH ON INTELLECTUAL DISABILITIES.
p.000729: The Director of the Institute shall conduct and support re- search and related activities into the causes,
p.000729: prevention, and treat- ment of intellectual disabilities.
p.000729: ASSOCIATE DIRECTOR FOR PREVENTION
p.000729: SEC. 451. ø285g–3¿ There shall be in the Institute an Associate Director for Prevention to coordinate and promote the
p.000729: programs in the Institute concerning the prevention of health problems of moth- ers and children. The Associate
...

p.000733: (D) develop model continuing education programs for such professionals; and
p.000733: (E) disseminate information to such professionals and the public.
p.000733: (2) A center may use funds provided under subsection (a) to provide stipends for health and allied health
p.000733: professionals enrolled in programs described in subparagraph (C) of paragraph (1), and to provide fees to
p.000733: individuals serving as subjects in clinical trials conducted under such paragraph.
p.000733: (d) The Director of the Institute shall, as appropriate, provide for the coordination of information
p.000733: among the centers assisted under this section.
p.000733: (e) Each center assisted under subsection (a) shall use the fa- cilities of a single institution, or be
p.000733: formed from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000733: Director of the Institute.
p.000733: (f) Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be
p.000733: extended for one or more additional periods not exceeding 5 years if the operations of such center have
p.000733: been reviewed by an appropriate technical and scientific peer review group established by the Director and if
p.000733: such group has recommended to the Director that such period should be extended.
p.000733:
p.000733: PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
p.000733: SEC. 452B. ø285g–6¿ The Director of the Institute shall estab- lish and maintain within the Institute an
p.000733: intramural laboratory and clinical research program in obstetrics and gynecology.
p.000733: CHILD HEALTH RESEARCH CENTERS
p.000733: SEC. 452C. ø285g–7¿ The Director of the Institute shall de- velop and support centers for conducting
p.000733: research with respect to child health. Such centers shall give priority to the expeditious transfer of
p.000733: advances from basic science to clinical applications and improving the care of infants and children.
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p.000733: January 30, 2020
p.000733:
p.000733: PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH
p.000733: SEC. 452D. ø285g–8¿ (a) IN GENERAL.—Not later than October 1, 1993, the Director of the Institute shall
p.000733: commence a study for the purpose of providing information on the general health and well-being of
p.000733: adolescents in the United States, including, with re- spect to such adolescents, information on—
p.000733: (1) the behaviors that promote health and the behaviors that are detrimental to health; and
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
...

p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000833: January 30, 2020
p.000833:
p.000833: priate, for individuals with a mental or substance use dis- order;
p.000833: (D) identify opportunities to collaborate with the Health Resources and Services Administration to
p.000833: develop or improve—
p.000833: (i) initiatives to encourage individuals to pursue careers (especially in rural and underserved areas and with
p.000833: rural and underserved populations) as psychia- trists, including child and adolescent psychiatrists,
p.000833: psychologists, psychiatric nurse practitioners, physi- cian assistants, clinical social workers, certified
p.000833: peer support specialists, licensed professional counselors, or other licensed or certified mental health or
p.000833: substance use disorder professionals, including such profes- sionals specializing in the diagnosis,
p.000833: evaluation, or treatment of adults with a serious mental illness or children with a serious emotional
p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
...

p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
p.000849: (A) individual, group, and family counseling, as appro- priate, regarding substance use disorders; and
p.000849: (B) follow-up services to assist the woman in pre- venting a relapse into such a disorder.
p.000849: (d) REQUIRED SUPPLEMENTAL SERVICES.—In the case of an eli- gible woman, the services referred to in subsection (a)(3)
p.000849: are as fol- lows:
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p.000849: January 30, 2020
p.000849: (1) Prenatal and postpartum health care.
p.000849: (2) Referrals for necessary hospital services.
p.000849: (3) For the infants and children of the woman—
p.000849: (A) pediatric health care, including treatment for any perinatal effects of a maternal substance use disorder
p.000849: and including screenings regarding the physical and mental de- velopment of the infants and children;
p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849: January 30, 2020
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p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
p.000849: (A) the applicant has the capacity to carry out a pro- gram described in subsection (a);
p.000849: (B) the plans of the applicant for such a program are consistent with the policies of such agency
p.000849: regarding the treatment of substance use disorders; and
p.000849: (C) the applicant, or any entity through which the ap- plicant will provide authorized services, meets all applica- ble
p.000849: State licensure or certification requirements regarding the provision of the services involved.
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p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
...

p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: 867
p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
p.000867: (dd) underage drinking prevention pro- grams that target youth within the juvenile justice and child
p.000867: welfare systems; and
p.000867: (ee) other State efforts or programs as deemed appropriate.
p.000867: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (d) NATIONAL MEDIA CAMPAIGN TO PREVENT UNDERAGE DRINK-
p.000867: ING.—
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p.000867: January 30, 2020
p.000867: (1) SCOPE OF THE CAMPAIGN.—The Secretary shall continue
p.000867: to fund and oversee the production, broadcasting, and evalua- tion of the national adult-oriented media
p.000867: public service cam- paign if the Secretary determines that such campaign is effec- tive in achieving the media
p.000867: campaign’s measurable objectives.
p.000867: (2) REPORT.—The Secretary shall provide a report to the Congress annually detailing the production,
p.000867: broadcasting, and evaluation of the campaign referred to in paragraph (1), and to detail in the report the
p.000867: effectiveness of the campaign in reduc- ing underage drinking, the need for and likely effectiveness of an expanded
p.000867: adult-oriented media campaign, and the feasi- bility and the likely effectiveness of a national
p.000867: youth-focused media campaign to combat underage drinking.
p.000867: (3) CONSULTATION REQUIREMENT.—In carrying out the media campaign, the Secretary shall direct the entity
...

p.000873: individuals with fetal al- cohol syndrome or alcohol-related birth defects and their families and for providing
p.000873: training on such conditions.
p.000873: (b) USE OF FUNDS.—An award under subsection (a) may be used to—
p.000873: (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for
p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
p.000873: (3) provide technical assistance to communities who do not have a comprehensive system of care for such
p.000873: individuals and their families;
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000873: Sec. 520 PUBLIC HEALTH SERVICE ACT 874
p.000873:
p.000873: (4) train community leaders, mental health and substance abuse professionals, families, law enforcement
p.000873: personnel, judges, health professionals, persons working in financial as- sistance programs, social service
p.000873: personnel, child welfare pro- fessionals, and other service providers on the implications of fetal alcohol
p.000873: syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
p.000873: (5) develop innovative techniques for preventing alcohol use by women in child bearing years; 9
p.000873: (6) perform other functions, to the extent authorized by the Secretary after consideration of recommendations made by
p.000873: the National Task Force on Fetal Alcohol Syndrome.
p.000873: (c) REPORT.—
p.000873: (1) IN GENERAL.—A recipient of an award under subsection
p.000873: (a) shall at the end of the period of funding report to the Sec- retary on any innovative techniques that have been
p.000873: discovered for preventing alcohol use among women of child bearing years.
p.000873: (2) DISSEMINATION OF FINDINGS.—The Secretary shall upon receiving a report under paragraph (1) disseminate the
p.000873: find- ings to appropriate public and private entities.
p.000873: (d) DURATION OF AWARDS.—With respect to an award under subsection (a), the period during which
p.000873: payments under such award are made to the recipient may not exceed 5 years.
p.000873: (e) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a) and shall disseminate
p.000873: the findings with respect to each such evaluation to appropriate public and pri- vate entities.
p.000873: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000873: to be appropriated
p.000873: $5,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003.
p.000873: Subpart 3—Center for Mental Health Services
p.000873: CENTER FOR MENTAL HEALTH SERVICES
p.000873: SEC. 520. ø290bb–31¿ (a) ESTABLISHMENT.—There is estab- lished in the Administration a Center for Mental
p.000873: Health Services (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000873: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000873: individ- uals with extensive experience or academic qualifications in the provision of mental health
p.000873: services or in the evaluation of mental health service systems.
p.000873: (b) DUTIES.—The Director of the Center shall—
p.000873: (1) design national goals and establish national priorities for—
p.000873: (A) the prevention of mental illness; and
p.000873: (B) the promotion of mental health;
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p.000879: 879
p.000879: PUBLIC HEALTH SERVICE ACT
p.000879: Sec. 520E
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p.000879: January 30, 2020
p.000879: SEC. 520E. ø290bb–36¿ YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
p.000879: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance
p.000879: Use, shall award grants or cooperative agreements to eligible entities to—
p.000879: (1) develop and implement State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention strate- gies in schools, educational institutions, juvenile justice sys- tems, substance use
p.000879: disorder programs, mental health pro- grams, foster care systems, and other child and youth support organizations;
p.000879: (2) support public organizations and private nonprofit or- ganizations actively involved in State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies and in the development
p.000879: and continuation of State-spon- sored statewide youth suicide early intervention and preven- tion strategies;
p.000879: (3) provide grants to institutions of higher education to co- ordinate the implementation of State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies;
p.000879: (4) collect and analyze data on State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention serv- ices that can be used to monitor the effectiveness of such serv- ices and for research, technical
p.000879: assistance, and policy develop- ment; and
p.000879: (5) assist eligible entities, through State-sponsored state- wide or tribal youth suicide early
p.000879: intervention and prevention strategies, in achieving targets for youth suicide reductions under title V of the
p.000879: Social Security Act.
p.000879: (b) ELIGIBLE ENTITY.—
p.000879: (1) DEFINITION.—In this section, the term ‘‘eligible entity’’ means—
p.000879: (A) a State;
p.000879: (B) a public organization or private nonprofit organiza- tion designated by a State to develop or direct the
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p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
p.000881:
p.000881: that child-serving professionals and providers involved in early intervention and prevention services are properly
p.000881: trained in ef- fectively identifying youth who are at risk for suicide;
p.000881: (11) provide continuous training activities for child care professionals and community care providers on the
p.000881: latest youth suicide early intervention and prevention services practices and strategies;
p.000881: (12) conduct annual self-evaluations of outcomes and ac- tivities, including consulting with interested families
p.000881: and advo- cacy organizations;
p.000881: (13) provide services in areas or regions with rates of youth suicide that exceed the national average
p.000881: as determined by the Centers for Disease Control and Prevention; and
p.000881: (14) obtain informed written consent from a parent or legal guardian of an at-risk child before involving the
p.000881: child in a youth suicide early intervention and prevention program.
p.000881: (d) REQUIREMENT FOR DIRECT SERVICES.—Not less than 85 per- cent of grant funds received under this section shall be
p.000881: used to pro- vide direct services, of which not less than 5 percent shall be used for activities authorized under
p.000881: subsection (a)(3).
p.000881: (e) COORDINATION AND COLLABORATION.—
p.000881: (1) IN GENERAL.—In carrying out this section, the Sec- retary shall collaborate with relevant Federal agencies
p.000881: and sui- cide working groups responsible for early intervention and pre- vention services relating to youth suicide.
p.000881: (2) CONSULTATION.—In carrying out this section, the Sec- retary shall consult with—
p.000881: (A) State and local agencies, including agencies re- sponsible for early intervention and prevention
p.000881: services under title XIX of the Social Security Act, the State Chil- dren’s Health Insurance Program
p.000881: under title XXI of the Social Security Act, and programs funded by grants under title V of the Social Security Act;
p.000881: (B) local and national organizations that serve youth at risk for suicide and their families;
p.000881: (C) relevant national medical and other health and education specialty organizations;
p.000881: (D) youth who are at risk for suicide, who have sur- vived suicide attempts, or who are currently receiving
p.000881: care from early intervention services;
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p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
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p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: 883
p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
...

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p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
p.000883:
p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
p.000883: (B) in the case of a consortium of States, receive the sup- port of all States involved;
p.000883: (2) provide for the timely assessment, treatment, or refer- ral for mental health or substance abuse
p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
p.000883: (e) CONDITION.—An applicant for a grant or cooperative agree- ment under subsection (a) shall demonstrate to the
p.000883: Secretary that the application complies with the State-sponsored statewide early intervention and prevention
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p.000911: January 30, 2020
p.000911: mining the extent to which any disclosure of all or any part of any record is necessary, shall impose
p.000911: appropriate safeguards against unauthorized disclosure.
p.000911: (c) USE OF RECORDS IN CRIMINAL PROCEEDINGS.—Except as au- thorized by a court order granted under
p.000911: subsection (b)(2)(C), no record referred to in subsection (a) may be used to initiate or sub- stantiate any criminal
p.000911: charges against a patient or to conduct any investigation of a patient.
p.000911: (d) APPLICATION.—The prohibitions of this section continue to apply to records concerning any individual who has
p.000911: been a patient, irrespective of whether or when such individual ceases to be a pa- tient.
p.000911: (e) NONAPPLICABILITY.—The prohibitions of this section do not apply to any interchange of records—
p.000911: (1) within the Uniformed Services or within those compo- nents of the Department of Veterans Affairs furnishing
p.000911: health care to veterans; or
p.000911: (2) between such components and the Uniformed Services. The prohibitions of this section do not apply to the reporting
p.000911: under State law of incidents of suspected child abuse and neglect to the appropriate State or local
p.000911: authorities.
p.000911: (f) PENALTIES.—Any person who violates any provision of this section or any regulation issued pursuant to
p.000911: this section shall be fined in accordance with title 18, United States Code.
p.000911: (g) REGULATIONS.—Except as provided in subsection (h), the Secretary shall prescribe regulations to carry
p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
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p.000917: Sec. 547A PUBLIC HEALTH SERVICE ACT 918
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p.000917: (c) FEDERAL SHARE.—The Federal share of the costs of a pro- gram funded by a grant under this section may not
p.000917: exceed 85 per- cent.
p.000917: (d) USE OF FUNDS.—Grants awarded under subsection (b)—
p.000917: (1) shall be used to develop, expand, and enhance commu- nity and statewide recovery support services; and
p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
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p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
p.000927: (h) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant awarded under subsection (a), not later
p.000927: than 90 days after the end of the first year of the grant period, and annually thereafter for the
p.000927: duration of the grant period (including the dura- tion of any renewal period for such grant), the entity shall submit
p.000927: data, as appropriate, to the Secretary regarding—
p.000927: (1) the programs and activities funded by the grant;
p.000927: (2) health outcomes of the population of individuals with a substance use disorder who received services
p.000927: from the Cen-
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000929: PUBLIC HEALTH SERVICE ACT
p.000929: Sec. 561
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p.000931: (A) Non-Federal contributions required in paragraph
p.000931: (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts
p.000931: provided by the Federal Government, or services assisted or subsidized to any significant extent by the
p.000931: Federal Government, may not be included in determining the amount of such non- Federal contributions.
p.000931: (B) In making a determination of the amount of non- Federal contributions for purposes of subparagraph
p.000931: (A), the Secretary may include only non-Federal contributions in excess of the average amount of
p.000931: non-Federal contribu- tions made by the public entity involved toward the pur- pose described in
p.000931: subsection (a) for the 2-year period pre- ceding the first fiscal year for which the entity receives a
p.000931: grant under such section.
p.000931: SEC. 562. ø290ff–1¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.000931: (a) SYSTEMS OF COMPREHENSIVE CARE.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that, with respect to children
p.000931: with a serious emotional disturbance, the public entity involved will carry out the purpose described in such section
p.000931: only through establishing and operating 1 or more systems of care for making each of the mental health services
p.000931: specified in subsection (c) available to each child provided access to the system. In providing for such a system,
p.000931: the public entity may make grants to, and enter into contracts with, public and nonprofit private entities.
p.000931: (2) STRUCTURE OF SYSTEM.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000931: para- graph (1) will—
p.000931: (A) be established in a community selected by the pub- lic entity involved;
p.000931: (B) consist of such public agencies and nonprofit pri- vate entities in the community as are necessary to
p.000931: ensure that each of the services specified in subsection (c) is avail- able to each child provided access to the
p.000931: system;
p.000931: (C) be established pursuant to agreements that the public entity enters into with the agencies and entities de-
p.000931: scribed in subparagraph (B);
p.000931: (D) coordinate the provision of the services of the sys- tem; and
p.000931: (E) establish an office whose functions are to serve as the location through which children are provided access to the
p.000931: system, to coordinate the provision of services of the system, and to provide information to the public
p.000931: regarding the system.
p.000931: (3) COLLABORATION OF LOCAL PUBLIC ENTITIES.—A funding agreement for a grant under section 561(a) is that,
p.000931: for pur- poses of the establishment and operation of a system of care under paragraph (1), the public
p.000931: entity involved will seek col- laboration among all public agencies that provide human serv- ices in the
p.000931: community in which the system is established, in- cluding but not limited to those providing mental
p.000931: health serv-
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
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p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
p.000931: provider involved to each child provided access to the system; and
p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
p.000931: (2) SPECIFICATION OF NON-MENTAL HEALTH SERVICES.—The providers referred to in paragraph (1) are providers of
p.000931: medical services other than mental health services, providers of edu- cational services, providers of
p.000931: vocational counseling and voca- tional rehabilitation services, and providers of protection and advocacy
p.000931: services with respect to mental health.
p.000931: (3) FACILITATION OF SERVICES OF CERTAIN PROGRAMS.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will, for purposes of para- graph (1), enter into a
p.000931: memorandum of understanding regard- ing facilitation of—
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: 933
p.000933: PUBLIC HEALTH SERVICE ACT
p.000933: Sec. 562
p.000933:
p.000933: (A) services available pursuant to title XIX of the So- cial Security Act, including services regarding
p.000933: early peri- odic screening, diagnosis, and treatment;
p.000933: (B) services available under parts B and C of the Indi- viduals with Disabilities Education Act; and
p.000933: (C) services available under other appropriate pro- grams, as identified by the Secretary.
p.000933: (e) GENERAL PROVISIONS REGARDING SERVICES OF SYSTEM.—
p.000933: (1) CASE MANAGEMENT SERVICES.—A funding agreement for a grant under section 561(a) is that a system of care
p.000933: under subsection (a) will provide for the case management of each child provided access to the system in
p.000933: order to ensure that—
p.000933: (A) the services provided through the system to the child are coordinated and that the need of each such child
p.000933: for the services is periodically reassessed;
p.000933: (B) information is provided to the family of the child on the extent of progress being made toward the
p.000933: objectives established for the child under the plan of services imple- mented for the child pursuant to
p.000933: section 563; and
p.000933: (C) the system provides assistance with respect to—
p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
p.000933:
p.000933:
p.000933:
p.000933:
p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000933:
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
...

p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
p.000933: (b) MULTIDISCIPLINARY TEAM.—A funding agreement for a grant under section 561(a) is that the plan
p.000933: required in subsection
p.000933: (a) will be developed, and reviewed and as appropriate revised not less than once each year, by a
p.000933: multidisciplinary team of appro- priately qualified individuals who provide services through the sys- tem,
p.000933: including as appropriate mental health services, other health
p.000933:
p.000933: January 30, 2020 As Amended Through P.L. 116-94,
p.000933: Enacted December 20, 2019
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p.000935: 935
p.000935: PUBLIC HEALTH SERVICE ACT
p.000935: Sec. 564
p.000935:
p.000935: services, educational services, social services, and vocational coun- seling and rehabilitation; 16
p.000935: (c) COORDINATION WITH SERVICES UNDER INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—A funding agreement
p.000935: for a grant under section 561(a) is that, with respect to a plan under sub- section (a) for a child,
p.000935: the multidisciplinary team required in sub- section (b) will—
p.000935: (1) in developing, carrying out, reviewing, and revising the plan consider any individualized education program
p.000935: in effect for the child pursuant to part B of the Individuals with Dis- abilities Education Act;
p.000935: (2) ensure that the plan is consistent with such individual- ized education program and provides for coordinating
p.000935: services under the plan with services under such program; and
p.000935: (3) ensure that the memorandum of understanding entered into under section 562(d)(3)(B) regarding such Act
p.000935: includes provisions regarding compliance with this subsection.
p.000935: (d) CONTENTS OF PLAN.—A funding agreement for a grant under section 561(a) is that the plan required in
p.000935: subsection (a) for a child will—
p.000935: (1) identify and state the needs of the child for the services available pursuant to section 562 through the system;
p.000935: (2) provide for each of such services that is appropriate to the circumstances of the child, including, except in the
p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
p.000935: day treat- ment under paragraph (5) of such section, and foster care or group homes under paragraph (7)
p.000935: of such section; and
p.000935: (C) the development of individualized plans for pur- poses of section 563;
p.000935:
p.000935:
p.000935:
p.000935:
p.000935: January 30, 2020
p.000935: 16 So in law. See section 119 of Public Law 102–321 (106 Stat. 349). Probably should be a pe- riod.
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000935:
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p.000935: Sec. 564 PUBLIC HEALTH SERVICE ACT 936
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p.000935: health of children with a serious emotional disturbance.
p.000935: (b) COMPREHENSIVE PLAN.—The Secretary may make a grant under section 561(a) only if, with respect to the
p.000935: jurisdiction of the public entity involved, the entity has submitted to the Secretary, and has had approved
p.000935: by the Secretary, a plan for the development of a jurisdiction-wide system of care for community-based services
p.000935: for children with a serious emotional disturbance that specifies the progress the public entity has made in developing
p.000935: the jurisdiction- wide system, the extent of cooperation across agencies serving chil- dren in the establishment of the
p.000935: system, the Federal and non-Fed- eral resources currently committed to the establishment of the sys- tem, and the
p.000935: current gaps in community services and the manner in which the grant under section 561(a) will be
p.000935: expended to ad- dress such gaps and establish local systems of care.
p.000935: (c) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—A fund- ing agreement for a grant under section 561(a) is
p.000935: that, if a charge is imposed for the provision of services under the grant, such charge—
p.000935: (1) will be made according to a schedule of charges that is made available to the public;
p.000935: (2) will be adjusted to reflect the income of the family of the child involved; and
p.000935: (3) will not be imposed on any child whose family has in- come and resources of equal to or less than 100
p.000935: percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised
p.000935: by the Secretary in ac- cordance with section 673(2) of the Omnibus Budget Reconcili- ation Act of 1981.
p.000935: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A funding agreement for a grant under
p.000935: section 561(a) is that the grant, and the non-Federal contributions made with re- spect to the grant,
p.000935: will not be expended to make payment for any item or service to the extent that payment has been
p.000935: made, or can reasonably be expected to be made, with respect to such item or service—
p.000935: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000935: health benefits program; or
p.000935: (2) by an entity that provides health services on a prepaid basis.
p.000935: (e) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 561(a) is
p.000935: that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
p.000935: grant by the public entity involved.
p.000935: (f) REPORTS TO SECRETARY.—A funding agreement for a grant under section 561(a) is that the public entity
p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
...

p.000937: outcomes of services provided by such systems, other
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
p.000937:
p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
p.000937: first appro- priated under subsection (c), and annually thereafter, submit to the Congress a report
p.000937: summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year and making such
p.000937: recommendations for administrative and legisla- tive initiatives with respect to this section as the Secretary de-
p.000937: termines to be appropriate.
p.000937: (d) DEFINITIONS.—For purposes of this part:
p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
p.000937: or adop- tive, as the case may be) and any foster parents of the child.
p.000937: (3) The term ‘‘funding agreement’’, with respect to a grant under section 561(a) to a public entity, means that
p.000937: the Sec- retary may make such a grant only if the public entity makes the agreement involved.
p.000937: (4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any child who has a
p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
p.000937:
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p.000937: January 30, 2020
p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
...

p.000939: (e) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000939: period during which payments under such an award will be made to the recipient may not exceed 5 years.
p.000939: (f) EVALUATION.—The Secretary shall conduct an evaluation of each project carried out under this section and
p.000939: shall disseminate the results of such evaluations to appropriate public and private entities.
p.000939: (g) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000939: programs to dissemi- nate the findings of the knowledge development and application under this section to
p.000939: the general public and to health care profes- sionals.
p.000939: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000939: $100,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and
p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
p.000939: (2) the development of knowledge with regard to evidence- based practices for identifying and treating mental,
p.000939: behavioral, and biological disorders of children and youth resulting from witnessing or experiencing a
p.000939: traumatic event.
p.000939: (b) PRIORITIES.—In awarding grants, contracts or cooperative agreements under subsection (a)(2) (related to
p.000939: the development of knowledge on evidence-based practices for treating mental, behav- ioral, and biological
p.000939: disorders associated with psychological trau- ma), the Secretary shall give priority to universities,
p.000939: hospitals, mental health agencies, and other programs that have established clinical expertise and research
p.000939: experience in the field of trauma-re- lated mental disorders.
p.000939: (c) CHILD OUTCOME DATA.—The NCTSI coordinating center de- scribed in subsection (a)(1) shall collect, analyze, report,
p.000939: and make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding
p.000939: the early identification and de- livery of evidence-based treatment and services for children and families
p.000939: served by the NCTSI grantees.
p.000939: (d) TRAINING.—The NCTSI coordinating center shall facilitate the coordination of training initiatives in
p.000939: evidence-based and trau-
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000939:
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p.000941: 941
p.000941: PUBLIC HEALTH SERVICE ACT
p.000941: Sec. 591
p.000941:
p.000941: ma-informed treatments, interventions, and practices offered to NCTSI grantees, providers, and partners.
p.000941: (e) DISSEMINATION AND COLLABORATION.—The NCTSI coordi- nating center shall, as appropriate, collaborate with—
p.000941: (1) the Secretary, in the dissemination of evidence-based and trauma-informed interventions, treatments,
p.000941: products, and other resources to appropriate stakeholders; and
p.000941: (2) appropriate agencies that conduct or fund research within the Department of Health and Human Services, for
p.000941: pur- poses of sharing NCTSI expertise, evaluation data, and other activities, as appropriate.
p.000941: (f) REVIEW.—The Secretary shall, consistent with the peer-re- view process, ensure that NCTSI applications
p.000941: are reviewed by ap- propriate experts in the field as part of a consensus-review process. The Secretary shall
p.000941: include review criteria related to expertise and experience in child trauma and evidence-based practices.
p.000941: (g) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative
p.000941: agreements under subsection
p.000941: (a) are distributed equitably among the regions of the United States and among urban and rural areas.
p.000941: (h) EVALUATION.—The Secretary, as part of the application process, shall require that each applicant for
p.000941: a grant, contract or cooperative agreement under subsection (a) submit a plan for the rigorous evaluation
p.000941: of the activities funded under the grant, con- tract or agreement, including both process and outcomes
p.000941: evalua- tion, and the submission of an evaluation at the end of the project period.
p.000941: (i) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000941: period during which payments under such an award will be made to the recipient shall not be less than 4 years,
p.000941: but shall not exceed 5 years. Such grants, contracts or agreements may be renewed.
p.000941: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000941: $63,887,000 for each of fiscal years 2019 through 2023.
p.000941: (k) SHORT TITLE.—This section may be cited as the ‘‘Donald J. Cohen National Child Traumatic Stress Initiative’’.
p.000941:
p.000941: PART H—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN FACILI- TIES
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p.000941: SEC. 591. ø290ii¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN FACILITIES.
p.000941: (a) IN GENERAL.—A public or private general hospital, nursing facility, intermediate care facility, or other health
p.000941: care facility, that receives support in any form from any program supported in whole or in part with funds
p.000941: appropriated to any Federal department or agency shall protect and promote the rights of each resident of the
p.000941: facility, including the right to be free from physical or mental abuse, corporal punishment, and any
p.000941: restraints or involuntary se- clusions imposed for purposes of discipline or convenience.
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000941: Sec. 592 PUBLIC HEALTH SERVICE ACT 942
p.000941:
p.000941: (b) REQUIREMENTS.—Restraints and seclusion may only be im- posed on a resident of a facility described in subsection
p.000941: (a) if—
p.000941: (1) the restraints or seclusion are imposed to ensure the physical safety of the resident, a staff
p.000941: member, or others; and
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p.000943: (A) IN GENERAL.—Until such time as the State devel- ops a process to assure the proper training and
p.000943: certifi- cation of facility personnel in the skills and competencies referred in paragraph (1)(B), the facility
p.000943: involved shall de- velop and implement an interim procedure that meets the requirements of subparagraph (B).
p.000943: (B) REQUIREMENTS.—A procedure developed under subparagraph (A) shall—
p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000945: 945
p.000945: PUBLIC HEALTH SERVICE ACT
p.000945: Sec. 595
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p.000945: (i) ensure that a supervisory or senior staff person with training in restraint and seclusion who is com-
p.000945: petent to conduct a face-to-face assessment (as defined in regulations promulgated by the Secretary), will as-
p.000945: sess the mental and physical well-being of the child or youth being restrained or secluded and assure that the
p.000945: restraint or seclusion is being done in a safe manner;
p.000945: (ii) ensure that the assessment required under clause (i) take place as soon as practicable, but in no
p.000945: case later than 1 hour after the initiation of the re- straint or seclusion; and
p.000945: (iii) ensure that the supervisory or senior staff person continues to monitor the situation for the dura- tion
p.000945: of the restraint and seclusion.
p.000945: (3) LIMITATIONS.—
p.000945: (A) IN GENERAL.—The use of a drug or medication that is used as a restraint to control behavior or restrict
p.000945: the resident’s freedom of movement that is not a standard treatment for the resident’s medical or
p.000945: psychiatric condi- tion in nonmedical community-based facilities for children and youth described in subsection
p.000945: (a)(1) is prohibited.
p.000945: (B) PROHIBITION.—The use of mechanical restraints in non-medical, community-based facilities for children and
p.000945: youth described in subsection (a)(1) is prohibited.
p.000945: (C) LIMITATION.—A non-medical, community-based fa- cility for children and youth described in subsection
...

p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
p.000951: National Center on Substance Abuse and Child Welfare.
p.000951: TITLE VI—ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000951: DECLARATION OF PURPOSE
p.000951: SEC. 600. ø291¿ The purpose of this title is—
p.000951: (a) to assist the several States in the carrying out of their programs for the construction and modernization of such
p.000951: public or other nonprofit community hospitals and other medical fa- cilities as may be necessary, in
p.000951: conjunction with existing facili-
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p.000951: January 30, 2020
p.000951: 24 Placement of section 550 is so in law. Section 8214 of Public Law 115-271 inserted a second section 550 at the end
p.000951: of title V.
p.000951: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: Sec. 601 PUBLIC HEALTH SERVICE ACT 952
p.000951:
p.000951: ties, to furnish adequate hospital, clinic, or similar services to all their people;
p.000951: (b) to stimulate the development of new or improved types of physical facilities for medical, diagnostic,
p.000951: preventive, treat- ment, or rehabilitative services; and
p.000951: (c) to promote research, experiments, and demonstrations relating to the effective development and utilization of
p.000951: hospital, clinic, or similar services, facilities, and resources, and to pro- mote the coordination of such
p.000951: research, experiments, and dem- onstrations and the useful application of their results.
...

p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
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p.001061: (e) TRAINEESHIPS.—
p.001061: (1) IN GENERAL.—With respect to amounts used under this section for the training of health professionals, such
p.001061: training programs shall be designed to—
p.001061: (A) make public health education more accessible to the public and private health workforce;
p.001061: (B) increase the relevance of public health academic preparation to public health practice in the future;
p.001061: (C) provide education or training for students from traditional on-campus programs in practice-based sites;
p.001061: or
p.001061: (D) develop educational methods and distance-based approaches or technology that address adult learning re-
p.001061: quirements and increase knowledge and skills related to community-based cultural diversity in public health
p.001061: edu- cation.
p.001061: (2) SEVERE SHORTAGE DISCIPLINES.—Amounts provided under grants or contracts under this section may be
p.001061: used for the operation of programs designed to award traineeships to students in accredited schools of
p.001061: public health who enter edu- cational programs in fields where there is a severe shortage of public health
p.001061: professionals, including epidemiology, biostatis- tics, environmental health, toxicology, public health
p.001061: nursing, nutrition, preventive medicine, maternal and child health, and behavioral and mental health professions.
p.001061: SEC. 766. ø295a¿ PUBLIC HEALTH TRAINING CENTERS.
p.001061: (a) IN GENERAL.—The Secretary may make grants or contracts for the operation of public health training centers.
p.001061: (b) ELIGIBLE ENTITIES.—
p.001061: (1) IN GENERAL.—A public health training center shall be an accredited school of public health, or another
p.001061: public or non- profit private institution accredited for the provision of grad- uate or specialized training in
p.001061: public health, that plans, devel- ops, operates, and evaluates projects that are in furtherance of the goals
p.001061: established by the Secretary for the year 2000 in the areas of preventive medicine, health promotion and disease
p.001061: prevention, or improving access to and quality of health serv- ices in medically underserved communities.
p.001061: (2) PREFERENCE.—In awarding grants or contracts under this section the Secretary shall give preference to
p.001061: accredited schools of public health.
p.001061: (c) CERTAIN REQUIREMENTS.—With respect to a public health training center, an award may not be made
p.001061: under subsection (a) unless the program agrees that it—
p.001061: (1) will establish or strengthen field placements for stu- dents in public or nonprofit private health
p.001061: agencies or organi- zations;
p.001061: (2) will involve faculty members and students in collabo- rative projects to enhance public health
p.001061: services to medically underserved communities;
p.001061: (3) will specifically designate a geographic area or medi- cally underserved population to be served by
p.001061: the center that shall be in a location removed from the main location of the
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p.001061: teaching facility of the school that is participating in the pro- gram with such center; and
p.001061: (4) will assess the health personnel needs of the area to be served by the center and assist in the planning
p.001061: and develop- ment of training programs to meet such needs.
p.001061: SEC. 767. ø295b¿ PUBLIC HEALTH TRAINEESHIPS.
p.001061: (a) IN GENERAL.—The Secretary may make grants to accred- ited schools of public health, and to other
p.001061: public or nonprofit pri- vate institutions accredited for the provision of graduate or special- ized training in
p.001061: public health, for the purpose of assisting such schools and institutions in providing traineeships to
p.001061: individuals de- scribed in subsection (b)(3).
p.001061: (b) CERTAIN REQUIREMENTS.—
p.001061: (1) AMOUNT.—The amount of any grant under this section shall be determined by the Secretary.
p.001061: (2) USE OF GRANT.—Traineeships awarded under grants made under subsection (a) shall provide for tuition
p.001061: and fees and such stipends and allowances (including travel and sub- sistence expenses and dependency
p.001061: allowances) for the trainees as the Secretary may deem necessary.
p.001061: (3) ELIGIBLE INDIVIDUALS.—The individuals referred to in subsection (a) are individuals who are pursuing a
p.001061: course of study in a health professions field in which there is a severe shortage of health professionals
p.001061: (which fields include the fields of epidemiology, environmental health, biostatistics, toxicology, nutrition, and
p.001061: maternal and child health).
p.001061: SEC. 768. ø295c¿ PREVENTIVE MEDICINE AND PUBLIC HEALTH TRAIN- ING GRANT PROGRAM.
p.001061: (a) GRANTS.—The Secretary, acting through the Administrator of the Health Resources and Services
p.001061: Administration and in con- sultation with the Director of the Centers for Disease Control and Prevention,
p.001061: shall award grants to, or enter into contracts with, eli- gible entities to provide training to graduate medical
p.001061: residents in preventive medicine specialties.
p.001061: (b) ELIGIBILITY.—To be eligible for a grant or contract under subsection (a), an entity shall be—
p.001061: (1) an accredited school of public health or school of medi- cine or osteopathic medicine;
p.001061: (2) an accredited public or private nonprofit hospital;
p.001061: (3) a State, local, or tribal health department; or
p.001061: (4) a consortium of 2 or more entities described in para- graphs (1) through (3).
p.001061: (c) USE OF FUNDS.—Amounts received under a grant or con- tract under this section shall be used to—
p.001061: (1) plan, develop (including the development of curricula), operate, or participate in an accredited residency
p.001061: or internship program in preventive medicine or public health;
p.001061: (2) defray the costs of practicum experiences, as required in such a program; and
p.001061: (3) establish, maintain, or improve—
p.001061: (A) academic administrative units (including depart- ments, divisions, or other appropriate units) in
p.001061: preventive medicine and public health; or
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p.001063: traineeships shall assure to the satisfaction of the Secretary that the entity will give priority to
p.001063: awarding the traineeships to students who demonstrate a commitment to employment with public or non- profit
p.001063: private entities in the fields with respect to which the traineeships are awarded.
p.001063: SEC. 770. ø295e¿ AUTHORIZATION OF APPROPRIATIONS.
p.001063: (a) IN GENERAL.—For the purpose of carrying out this subpart, there is authorized to be appropriated $43,000,000
p.001063: for fiscal year
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p.001063: Sec. 775 PUBLIC HEALTH SERVICE ACT 1064
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p.001063: 2011, and such sums as may be necessary for each of the fiscal years 2012 through 2015.
p.001063: (b) LIMITATION REGARDING CERTAIN PROGRAM.—In obligating amounts appropriated under subsection (a), the
p.001063: Secretary may not obligate more than 30 percent for carrying out section 767.
p.001063: Subpart 3—Recruitment and Retention Programs
p.001063:
p.001063: SEC. 775. ø295f¿ INVESTMENT IN TOMORROW’S PEDIATRIC HEALTH CARE WORKFORCE.
p.001063: (a) ESTABLISHMENT.—The Secretary shall establish and carry out a pediatric specialty loan repayment program under
p.001063: which the eligible individual agrees to be employed full-time for a specified period (which shall not be less
p.001063: than 2 years) in providing pediatric medical subspecialty, pediatric surgical specialty, or child and ado- lescent
p.001063: mental and behavioral health care, including substance abuse prevention and treatment services.
p.001063: (b) PROGRAM ADMINISTRATION.—Through the program estab- lished under this section, the Secretary shall enter
p.001063: into contracts with qualified health professionals under which—
p.001063: (1) such qualified health professionals will agree to provide pediatric medical subspecialty, pediatric surgical
p.001063: specialty, or child and adolescent mental and behavioral health care in an area with a shortage of the
p.001063: specified pediatric subspecialty that has a sufficient pediatric population to support such pediatric
p.001063: subspecialty, as determined by the Secretary; and
p.001063: (2) the Secretary agrees to make payments on the prin- cipal and interest of undergraduate, graduate, or
p.001063: graduate medical education loans of professionals described in para- graph (1) of not more than $35,000
p.001063: a year for each year of agreed upon service under such paragraph for a period of not more than 3
p.001063: years during the qualified health professional’s—
p.001063: (A) participation in an accredited pediatric medical subspecialty, pediatric surgical specialty, or child and
p.001063: ado- lescent mental health subspecialty residency or fellowship; or
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p.001063: (B) employment as a pediatric medical subspecialist, pediatric surgical specialist, or child and adolescent
p.001063: mental health professional serving an area or population described in such paragraph.
p.001063: (c) IN GENERAL.—
p.001063: (1) ELIGIBLE INDIVIDUALS.—
p.001063: (A) PEDIATRIC MEDICAL SPECIALISTS AND PEDIATRIC SURGICAL SPECIALISTS.—For purposes of contracts with re-
p.001063: spect to pediatric medical specialists and pediatric surgical specialists, the term ‘‘qualified health
p.001063: professional’’ means a licensed physician who—
p.001063: (i) is entering or receiving training in an accred- ited pediatric medical subspecialty or pediatric sur-
p.001063: gical specialty residency or fellowship; or
p.001063: (ii) has completed (but not prior to the end of the calendar year in which this section is enacted) the
p.001063: training described in subparagraph (B).
p.001063: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001065: 1065
p.001065: PUBLIC HEALTH SERVICE ACT
p.001065: Sec. 776
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p.001065: January 30, 2020
p.001065: (B) CHILD AND ADOLESCENT MENTAL AND BEHAVIORAL HEALTH.—For purposes of contracts with respect to child and
p.001065: adolescent mental and behavioral health care, the term ‘‘qualified health professional’’ means a health
p.001065: care professional who—
p.001065: (i) has received specialized training or clinical ex- perience in child and adolescent mental health in psy-
p.001065: chiatry, psychology, school psychology, behavioral pe- diatrics, psychiatric nursing, social work, school social
p.001065: work, substance abuse disorder prevention and treat- ment, marriage and family therapy, school counseling, or
p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
p.001065: (1) are or will be working in a school or other pre-kinder- garten, elementary, or secondary education
p.001065: setting;
p.001065: (2) have familiarity with evidence-based methods and cul- tural and linguistic competence health care services;
p.001065: and
p.001065: (3) demonstrate financial need.
p.001065: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $30,000,000 for each of
p.001065: fiscal years 2010 through 2014 to carry out subsection (c)(1)(A) and $20,000,000 for each of fiscal
p.001065: years 2010 through 2013 to carry out subsection (c)(1)(B).
p.001065: SEC. 776. ø295f–1¿ PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
p.001065: (a) ESTABLISHMENT.—The Secretary shall establish the Public Health Workforce Loan Repayment Program
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p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
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p.001123: reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the
p.001123: Department of Veterans Affairs, the Office of Personnel Management, and other public or pri- vate entities.
p.001123: (3) GRANTS AND CONTRACTS.—In addition to conducting as- sessments, the Director may make grants to, or enter
p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001123: Sec. 917 PUBLIC HEALTH SERVICE ACT 1124
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p.001123: the victims referred to in paragraph (1), and of other appro- priate public and private entities
p.001123: (including medical societies, victim services organizations, sexual assault prevention organi- zations, and social
p.001123: services organizations).
p.001123: SEC. 917. ø299b–6¿ COORDINATION OF FEDERAL GOVERNMENT QUAL- ITY IMPROVEMENT EFFORTS.
p.001123: (a) REQUIREMENT.—
p.001123: (1) IN GENERAL.—To avoid duplication and ensure that Federal resources are used efficiently and
p.001123: effectively, the Sec- retary, acting through the Director, shall coordinate all re- search, evaluations, and
p.001123: demonstrations related to health serv- ices research, quality measurement and quality improvement activities
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p.001123: departments with an independent, external review of their quality over- sight, quality improvement and quality
p.001123: research programs, the Secretary shall enter into a contract with the Institute of Medi- cine—
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p.001123: (A) to describe and evaluate current quality improve- ment, quality research and quality monitoring
p.001123: processes through—
p.001123: (i) an overview of pertinent health services re- search activities and quality improvement efforts con-
p.001123: ducted by all Federal programs, with particular atten- tion paid to those under titles XVIII, XIX, and XXI of the
p.001123: Social Security Act; and
p.001123: (ii) a summary of the partnerships that the De- partment of Health and Human Services has pursued with
p.001123: private accreditation, quality measurement and improvement organizations; and
p.001123: (B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improve-
p.001123: ment programs through—
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001125: PUBLIC HEALTH SERVICE ACT
p.001125: Sec. 921
p.001125:
p.001125: (i) the improved coordination of activities across the medicare, medicaid and child health insurance
p.001125: programs under titles XVIII, XIX and XXI of the So- cial Security Act and health services research pro-
p.001125: grams;
p.001125: (ii) the strengthening of patient choice and partici- pation by incorporating state-of-the-art quality moni-
p.001125: toring tools and making information on quality avail- able; and
p.001125: (iii) the enhancement of the most effective pro- grams, consolidation as appropriate, and elimination of
p.001125: duplicative activities within various Federal agen- cies.
p.001125: (2) REQUIREMENTS.—
p.001125: (A) IN GENERAL.—The Secretary shall enter into a con- tract with the Institute of Medicine for the preparation—
p.001125: (i) not later than 12 months after the date of the enactment of this title, of a report providing an
p.001125: over- view of the quality improvement programs of the De- partment of Health and Human Services for the medi-
p.001125: care, medicaid, and CHIP programs under titles XVIII,
p.001125: XIX, and XXI of the Social Security Act; and
p.001125: (ii) not later than 24 months after the date of the enactment of this title, of a final report containing rec-
p.001125: ommendations.
p.001125: (B) REPORTS.—The Secretary shall submit the reports described in subparagraph (A) to the Committee on Fi-
p.001125: nance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on
p.001125: Ways and Means and the Committee on Commerce of the House of Representatives.
p.001125: PART C—PATIENT SAFETY IMPROVEMENT
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p.001165: distribution of such dis- eases and conditions.
p.001165: (3) APPLICATION.—To seek a grant under this subsection, an eligible entity shall submit an application to
p.001165: the Secretary at such time, in such manner, and containing such information as the Secretary may require.
p.001165: (4) PRIORITY.—In awarding grants under this subsection, the Secretary may give priority, as appropriate, to
p.001165: eligible enti- ties that have a relationship with a community-based organiza- tion that has experience in, or is
p.001165: capable of, providing services to individuals with heritable blood disorders, including sickle cell disease.
p.001165: (5) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ includes the 50 States, the District of
p.001165: Columbia, the Commonwealth of Puerto Rico, the United States Virgin Is- lands, the Commonwealth of the
p.001165: Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of Marshall
p.001165: Islands, the Republic of Palau, Indian tribes, a State or local health department, an institution of higher
p.001165: education, or a nonprofit entity with appropriate experi- ence to conduct the activities under this subsection.
p.001165: (b) DEMONSTRATION PROGRAM FOR THE DEVELOPMENT AND ES-
p.001165: TABLISHMENT OF SYSTEMIC MECHANISMS FOR THE PREVENTION AND
p.001165: TREATMENT OF SICKLE CELL DISEASE.—
p.001165: (1) AUTHORITY TO CONDUCT DEMONSTRATION PROGRAM.—
p.001165: (A) IN GENERAL.—The Administrator, through the Bu- reau of Primary Health Care and the Maternal and Child Health
p.001165: Bureau, shall continue efforts, including by award- ing grants, to develop or establish mechanisms to improve the
p.001165: treatment of sickle cell disease, and to improve the prevention and treatment of complications of sickle
p.001165: cell disease, in populations with a high proportion of individ- uals with sickle cell disease, including
p.001165: through—
p.001165: (i) the coordination of service delivery for individ- uals with sickle cell disease;
p.001165: (ii) genetic counseling and testing;
p.001165: (iii) bundling of technical services related to the prevention and treatment of sickle cell disease;
p.001165: (iv) training of health professionals; and
p.001165: (v) identifying and establishing other efforts re- lated to the expansion and coordination of education,
p.001165: treatment, and continuity of care programs for individ- uals with sickle cell disease.
p.001165: (B) GEOGRAPHIC DIVERSITY.—The Administrator shall, to the extent practicable, award grants under this
p.001165: section to eligible entities located in different regions of the United States.
p.001165: (2) ADDITIONAL REQUIREMENTS.—An eligible entity award- ed a grant under this subsection shall use
p.001165: funds made avail- able under the grant to carry out, in addition to the activities described in paragraph
p.001165: (1)(A), the following activities:
p.001165: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001165: Sec. 1106 PUBLIC HEALTH SERVICE ACT 1166
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p.001165: January 30, 2020
p.001165:
p.001165: (A) To facilitate and coordinate the delivery of edu- cation, treatment, and continuity of care for
p.001165: individuals with sickle cell disease under—
p.001165: (i) the entity’s collaborative agreement with a community-based sickle cell disease organization or a
p.001165: nonprofit entity that works with individuals who have sickle cell disease;
p.001165: (ii) the sickle cell disease newborn screening pro- gram for the State in which the entity is located; and
p.001165: (iii) the maternal and child health program under title V of the Social Security Act (42 U.S.C. 701 et seq.)
p.001165: for the State in which the entity is located.
p.001165: (B) To train nursing and other health staff who pro- vide care for individuals with sickle cell disease.
p.001165: (C) To enter into a partnership with adult or pediatric hematologists in the region and other regional experts
p.001165: in sickle cell disease at tertiary and academic health centers and State and county health offices.
p.001165: (D) To identify and secure resources for ensuring reim- bursement under the medicaid program, State children’s
p.001165: health insurance program, and other health programs for the prevention and treatment of sickle cell disease.
p.001165: (E) To provide or coordinate services for adolescents with sickle cell disease making the transition to
p.001165: adult health care.
p.001165: (3) NATIONAL COORDINATING CENTER.—
p.001165: (A) ESTABLISHMENT.—The Administrator shall enter into a contract with an entity to serve as the National Co-
p.001165: ordinating Center for the demonstration program con- ducted under this subsection.
p.001165: (B) ACTIVITIES DESCRIBED.—The National Coordi- nating Center shall—
p.001165: (i) collect, coordinate, monitor, and distribute data, best practices, and findings regarding the activi-
p.001165: ties funded under grants made to eligible entities under the demonstration program;
p.001165: (ii) develop a model protocol for eligible entities with respect to the prevention and treatment of sickle cell
p.001165: disease;
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p.001167: January 30, 2020
p.001167:
p.001167: TOURETTE SYNDROME
p.001167: SEC. 1108. ø300b–7¿ (a) IN GENERAL.—The Secretary shall de- velop and implement outreach programs to educate the
p.001167: public, health care providers, educators and community based organiza- tions about the etiology, symptoms,
p.001167: diagnosis and treatment of Tourette Syndrome, with a particular emphasis on children with Tourette Syndrome.
p.001167: Such programs may be carried out by the Sec- retary directly and through awards of grants or contracts to public or
p.001167: nonprofit private entities.
p.001167: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) shall include—
p.001167: (1) the production and translation of educational materials, including public service announcements;
p.001167: (2) the development of training material for health care providers, educators and community based
p.001167: organizations; and
p.001167: (3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and
p.001167: in minor- ity groups.
p.001167: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001167: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
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p.001169: to facilitate comment from any person, including through hear- ings and other methods used to facilitate
p.001169: comments from the public.
p.001169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: Sec. 1110 PUBLIC HEALTH SERVICE ACT 1170
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p.001169: January 30, 2020
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p.001169: (2) COMMENTS.—Comments received by the State after the publication described in paragraph (1) shall be addressed
p.001169: in the application for a grant under this section.
p.001169: (i) TECHNICAL ASSISTANCE.—The Secretary shall provide to en- tities receiving grants under subsection (a) such
p.001169: technical assist- ance as may be necessary to ensure the quality of programs con- ducted under this
p.001169: section.
p.001169: SEC. 1110. ø300b–9¿ EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING AND FOLLOWUP PROGRAMS.
p.001169: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to provide for the conduct of
p.001169: demonstration programs to evaluate the effectiveness, including with respect to timeliness, of screening,
p.001169: followup, counseling or health care services in reducing the morbidity and mortality caused by
p.001169: heritable disorders in newborns and children.
p.001169: (b) DEMONSTRATION PROGRAMS.—A demonstration program conducted under a grant under this section shall be
p.001169: designed to evaluate and assess, within the jurisdiction of the entity receiving such grant—
p.001169: (1) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services for
p.001169: newborns and chil- dren at risk for heritable disorders in reducing the morbidity and mortality associated
p.001169: with such disorders, including, as ap- propriate, through the assessment of health and development outcomes for
p.001169: such children through adolescence;
p.001169: (2) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services in
p.001169: accurately and reli- ably diagnosing heritable disorders in newborns and children in a timely manner;
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p.001173: false-posi- tive rates and other quality indicators as determined by the Advisory Committee under section
p.001173: 1111;
p.001173: (4) maintain current information on the number of condi- tions for which screening is conducted in each State;
p.001173: and
p.001173: (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect
p.001173: to condi- tions detected by newborn screening.
p.001173: (b) INTERNET AVAILABILITY.—The Secretary, acting through the Administrator, shall ensure that the clearinghouse
p.001173: described under subsection (a)—
p.001173: (1) is available on the Internet;
p.001173: (2) includes an interactive forum;
p.001173: (3) is updated on a regular basis, but not less than quar- terly; and
p.001173: (4) provides—
p.001173: (A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have
p.001173: dem- onstrated expertise in newborn screening that supply re- search-based information on newborn screening
p.001173: tests cur- rently available throughout the United States;
p.001173: (B) information about newborn conditions and screen- ing services available in each State from
p.001173: laboratories cer- tified under subpart 2 of part F of title III, including infor- mation about supplemental screening
p.001173: that is available but not required, in the State where the infant is born;
p.001173: (C) current research on both treatable and not-yet treatable conditions for which newborn screening tests are
p.001173: available;
p.001173: (D) the availability of Federal funding for newborn and child screening for heritable disorders
p.001173: including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and
p.001173: (E) other relevant information as determined appro- priate by the Secretary.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001175: 1175
p.001175: PUBLIC HEALTH SERVICE ACT
p.001175: Sec. 1114
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p.001175: January 30, 2020
p.001175: (c) NONDUPLICATION.—In carrying out activities under this sec- tion, the Secretary shall ensure that such activities
p.001175: minimize dupli- cation and supplement, not supplant, existing information sharing efforts.
p.001175: SEC. 1113. ø300b–12¿ LABORATORY QUALITY AND SURVEILLANCE.
p.001175: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and
p.001175: taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children
p.001175: established under section 1111, shall provide for—
p.001175: (1) quality assurance for laboratories involved in screening newborns and children for heritable disorders,
p.001175: including qual- ity assurance for newborn-screening tests, timeliness for proc- essing such tests,
p.001175: performance evaluation services, and tech- nical assistance and technology transfer to newborn screening
p.001175: laboratories to ensure analytic validity and utility of screening tests; and
p.001175: (2) appropriate quality control and other performance test materials to evaluate the performance of new
p.001175: screening tools.
p.001175: (b) SURVEILLANCE ACTIVITIES.—The Secretary, acting through the Director of the Centers for Disease Control and
p.001175: Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders
p.001175: in Newborns and Children established under section 1111, may provide, as appropriate, for the
p.001175: coordina- tion of surveillance activities, including—
p.001175: (1) through standardized data collection and reporting, as well as the use of electronic health records; and
p.001175: (2) by promoting data sharing regarding newborn screen- ing with State-based birth defects and
p.001175: developmental disabil- ities monitoring programs.
p.001175: SEC. 1114. ø300b–13¿ INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD SCREENING.
p.001175: (a) PURPOSE.—It is the purpose of this section to—
p.001175: (1) assess existing activities and infrastructure, including activities on birth defects and developmental
p.001175: disabilities au- thorized under section 317C, in order to make recommenda- tions for programs to collect,
p.001175: analyze, and make available data on the heritable disorders recommended by the Advisory Com- mittee on Heritable
p.001175: Disorders in Newborns and Children under section 1111, including data on the incidence and prevalence of, as
p.001175: well as poor health outcomes resulting from, such dis- orders; and
p.001175: (2) make recommendations for the establishment of re- gional centers for the conduct of applied
p.001175: epidemiological re- search on effective interventions to promote the prevention of poor health outcomes
p.001175: resulting from such disorders as well as providing information and education to the public on such ef-
p.001175: fective interventions.
p.001175: (b) ESTABLISHMENT.—The Secretary shall establish an Inter- agency Coordinating Committee on Newborn and
p.001175: Child Screening (referred to in this section as the ‘‘Interagency Coordinating Com- mittee’’) to carry out
p.001175: the purpose of this section.
p.001175: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001175:
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p.001175: Sec. 1115 PUBLIC HEALTH SERVICE ACT 1176
p.001175: (c) COMPOSITION.—The Interagency Coordinating Committee shall be composed of the Director of the Centers
p.001175: for Disease Con- trol and Prevention, the Administrator of the Health Resources and Services Administration, the
p.001175: Director of the Agency for Healthcare Research and Quality, the Commissioner of Food and Drugs, and the
p.001175: Director of the National Institutes of Health, or their designees.
p.001175: (d) ACTIVITIES.—The Interagency Coordinating Committee shall—
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p.001175: January 30, 2020
p.001175: (1) report to the Secretary and the appropriate committees of Congress on its recommendations related to the purpose
p.001175: de- scribed in subsection (a); and
p.001175: (2) carry out other activities determined appropriate by the Secretary.
...

p.001177: and the conditions on the uniform screening panel (or the standard test existing on the uniform screening
p.001177: panel).
p.001177: (c) REPORTS.—The Director is encouraged to include informa- tion about the activities carried out under this
p.001177: section in the bien- nial report required under section 403. If such information is in- cluded, the Director
p.001177: shall make such information available to be in- cluded on the Internet Clearinghouse established under section
p.001177: 1112.
p.001177: (d) NONDUPLICATION.—In carrying out programs under this section, the Secretary shall minimize duplication
p.001177: and supplement, not supplant, existing efforts of the type carried out under this sec- tion.
p.001177: (e) PEER REVIEW.—Nothing in this section shall be construed to interfere with the scientific peer-review
p.001177: process at the National Institutes of Health.
p.001177: SEC. 1117. ø300b–16¿ AUTHORIZATION OF APPROPRIATIONS FOR NEW- BORN SCREENING PROGRAMS AND ACTIVITIES.
p.001177: There are authorized to be appropriated—
p.001177: (1) to carry out sections 1109, 1110, 1111, and 1112,
p.001177: $11,900,000 for each of fiscal years 2015 through 2019; and
p.001177: (2) to carry out section 1113, $8,000,000 for each of fiscal years 2015 through 2019.
p.001177: PART B—SUDDEN INFANT DEATH SYNDROME
p.001177:
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p.001177: January 30, 2020
p.001177:
p.001177: SUDDEN INFANT DEATH SYNDROME RESEARCH AND RESEARCH REPORTS
p.001177: SEC. 1122. ø300c–12¿ From the sums appropriated to the Eu- nice Kennedy Shriver National Institute of
p.001177: Child Health and
p.001177: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001177:
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p.001177: Sec. 1132 PUBLIC HEALTH SERVICE ACT 1178
p.001177:
p.001177: Human Development, the Secretary shall assure that there are ap- plied to research of the type described in
p.001177: subparagraphs (A) and
p.001177: (B) of subsection (b)(1) of this section such amounts each year as will be adequate, given the leads and
p.001177: findings then available from such research, in order to make maximum feasible progress toward identification of
p.001177: infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome.
p.001177: PART C—HEMOPHILIA PROGRAMS
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p.001177: January 30, 2020
p.001177: BLOOD SEPARATION CENTERS
p.001177: SEC. 1132. ø300c–22¿ (a) The Secretary may make grants to and enter into contracts with public and
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p.001201: (A) engaging stakeholders, including victims of human trafficking and Federal, State, local, and tribal partners, to
p.001201: develop a flexible training module—
p.001201: (i) for supporting activities under subsection (c);
p.001201: and
p.001201: (ii) that adapts to changing needs, settings, health
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p.001201: January 30, 2020
p.001201: care providers, and social service providers;
p.001201: (B) providing technical assistance to grantees related to implementing activities described in subsection
p.001201: (c) and reporting on any best practices identified by the grantees;
p.001201: (C) developing a reliable methodology for collecting data, and reporting such data, on the number of
p.001201: human trafficking victims identified and served by grantees in a manner that, at a minimum, prevents
p.001201: disclosure of indi- vidually identifiable information consistent with all appli- cable privacy laws and
p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001203: 1203
p.001203: PUBLIC HEALTH SERVICE ACT
p.001203: Sec. 1261
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p.001219: requirements of this sec- tion notwithstanding that it provides, with respect to coverage of- fered in
p.001219: connection with a group health plan in the small or large group market (as defined in section 2791(e)), an
p.001219: affiliation period consistent with the provisions of section 2701(g).
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001219:
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p.001219: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1220
p.001219:
p.001219: service. Such term includes a health service directly associated with an organ transplant only if such
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p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
p.001235: centum of the equity of the or- ganization, any person who is the beneficial owner of a mort- gage, deed of
p.001235: trust, note, or other interest secured by, and val- uing more than 5 per centum of the health maintenance orga-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001237: 1237
p.001237: PUBLIC HEALTH SERVICE ACT
p.001237: Sec. 1318
p.001237:
p.001237: nization, and, in the case of a health maintenance organization organized as a nonprofit corporation, an
p.001237: incorporator or mem- ber of such corporation under applicable State corporation law;
p.001237: (2) any entity in which a person described in paragraph (1)—
p.001237: (A) is an officer or director;
p.001237: (B) is a partner (if such entity is organized as a part- nership);
p.001237: (C) has directly or indirectly a beneficial interest of more than 5 per centum of the equity; or
p.001237: (D) has a mortgage, deed of trust, note, or other inter- est valuing more than 5 per centum of the assets of
p.001237: such entity;
p.001237: (3) any person directly or indirectly controlling, controlled by, or under common control with a health
p.001237: maintenance orga- nization; and
p.001237: (4) any spouse, child, or parent of an individual described in paragraph (1).
p.001237: (c) Each health maintenance organization shall make the infor- mation reported pursuant to subsection (a) available to
p.001237: its enrollees upon reasonable request.
p.001237: (d) The Secretary shall, as he deems necessary, conduct an evaluation of transactions reported to the
p.001237: Secretary under sub- section (a)(3) for the purpose of determining their adverse impact, if any, on the
p.001237: fiscal soundness and reasonableness of charges to the health maintenance organization with respect to which they
p.001237: tran- spired. The Secretary shall evaluate the reported transactions of not less than five, or if there are
p.001237: more than twenty health mainte- nance organizations reporting such transactions, not less than one- fourth of the
p.001237: health maintenance organizations reporting any such transactions under subsection (a)(3).
p.001237: (f) 4 Nothing in this section shall be construed to confer upon the Secretary any authority to approve
p.001237: or disapprove the rates charged by any health maintenance organization.
p.001237: (g) Any health maintenance organization failing to file with the Secretary the annual financial statement required in
p.001237: subsection (a) shall be ineligible for any Federal assistance under this title until such time as such
p.001237: statement is received by the Secretary and shall not be a qualified health maintenance organization for purposes of
p.001237: section 1310.
p.001237: (h) Whoever knowingly and willfully makes or causes to be made any false statement or representation of
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p.001269: appropriate use of health care.
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p.001269: January 30, 2020
p.001269: INFORMATION PROGRAMS
p.001269: SEC. 1704. ø300u–3¿ The Secretary is authorized to conduct and support by grant or contract (and encourage
p.001269: others to support) such activities as may be required to make information respecting health information and
p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
p.001271: dis- eases; and shall be designed to reach populations of different languages and of different social and
p.001271: economic backgrounds.
p.001271: (2) Securing the cooperation of the communication media, providers of health care, schools, and others in
p.001271: activities de- signed to promote and encourage the use of health maintaining information and behavior.
p.001271: (3) The study of health information and promotion in ad- vertising and the making to concerned Federal
p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
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p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: January 30, 2020
p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
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p.001297: January 30, 2020
p.001297:
p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
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p.001299: to increase (relative to fiscal year 1993) funding for such sys- tem; and
p.001299: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such system not
p.001299: less than an amount equal to the amount expended by the State for fiscal year 1994.
p.001299: (2) WAIVER.—
p.001299: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001299: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001299: adequate level of com- prehensive community mental health services for children with a serious emotional
p.001299: distrubance 2, as indicated by a comparison of the number of such children for which such services are sought with
p.001299: the availability in the State of the services.
p.001299: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001299: 120 days after the date on which the request is made.
p.001299: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001299: in- volved.
p.001299: (b) PROVIDERS OF SERVICES.—A funding agreement for a grant under section 1911 for a State is that, with respect to the
p.001299: plan sub- mitted under section 1912(a) for the fiscal year involved—
p.001299: (1) services under the plan will be provided only through appropriate, qualified community programs (which may
p.001299: include community mental health centers, child mental-health pro- grams, psychosocial rehabilitation
p.001299: programs, mental health peer-support programs, and mental-health primary consumer- directed programs); and
p.001299: (2) services under the plan will be provided through com- munity mental health centers only if the centers
p.001299: meet the cri- teria specified in subsection (c).
p.001299: (c) CRITERIA FOR MENTAL HEALTH CENTERS.—The criteria re- ferred to in subsection (b)(2) regarding
p.001299: community mental health centers are as follows:
p.001299: (1) With respect to mental health services, the centers pro- vide services as follows:
p.001299: (A) Services principally to individuals residing in a de- fined geographic area (hereafter in this subsection referred
p.001299: to as a ‘‘service area’’).
p.001299: (B) Outpatient services, including specialized out- patient services for children, the elderly,
p.001299: individuals with a serious mental illness, and residents of the service areas of the centers who have been
p.001299: discharged from inpatient treatment at a mental health facility.
p.001299:
p.001299:
p.001299:
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p.001299: January 30, 2020
p.001299: 2 So in law. See section 201 of Public Law 102–321 (106 Stat. 381). Probably should be ‘‘dis-
p.001299: turbance’’.
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
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p.001341:
p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
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p.001343: January 30, 2020
p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
p.001343: care services in a single setting or the capability of creating a network through which all care services
p.001343: would be provided; or
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p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be
p.001347: provided and how the applicant will provide such services;
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001349: 1349
p.001349: PUBLIC HEALTH SERVICE ACT
p.001349: Sec. 2006
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p.001349: January 30, 2020
p.001349: (6) a description of the manner in which adolescents need- ing services other than the services provided directly by
p.001349: the ap- plicant will be identified and how access and appropriate refer- ral to such other services (such as medicaid;
p.001349: licensed adoption agencies; maternity home services; public assistance; employ- ment services; child care
p.001349: services for adolescent parents; and other city, county, and State programs related to adolescent
p.001349: pregnancy) will be provided, including a description of a plan to coordinate such other services with
p.001349: the services supported under this title;
p.001349: (7) a description of the applicant’s capacity to continue services as Federal funds decrease and in the
p.001349: absence of Fed- eral assistance;
p.001349: (8) a description of the results expected from the provision of services, and the procedures to be used for evaluating
p.001349: those results;
p.001349: (9) a summary of the views of public agencies, providers of services, and the general public in the geographic
p.001349: area to be served, concerning the proposed use of funds provided for a demonstration project for services
p.001349: under this title and a de- scription of procedures used to obtain those views, and, in the case of applicants who
p.001349: propose to coordinate services adminis- tered by a State, the written comments of the appropriate State
p.001349: officials responsible for such services;
p.001349: (10) assurances that the applicant will have an ongoing quality assurance program;
p.001349: (11) assurances that, where appropriate, the applicant shall have a system for maintaining the
p.001349: confidentiality of pa- tient records in accordance with regulations promulgated by the Secretary;
p.001349: (12) assurances that the applicant will demonstrate its fi- nancial responsibility by the use of such
p.001349: accounting procedures and other requirements as may be prescribed by the Secretary;
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p.001359: for such injury or death.
p.001359: (9) This subsection applies only to a person who has sus- tained a vaccine-related injury or death and
p.001359: who is qualified to file a petition for compensation under the Program.
p.001359: (10) The Clerk of the United States Claims Court is au- thorized to continue to receive, and forward,
p.001359: petitions for com- pensation for a vaccine-related injury or death associated with the administration of a vaccine on
p.001359: or after October 1, 1992.
p.001359: (b) PETITIONERS.—
p.001359: (1)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal
p.001359: represent- ative of such person if such person is a minor or is disabled, or the legal representative of
p.001359: any person who died as the result of the administration of a vaccine set forth in the Vaccine In- jury
p.001359: Table may, if the person meets the requirements of sub- section (c)(1), file a petition for compensation
p.001359: under the Pro- gram.
p.001359: (B) No person may file a petition for a vaccine-related in- jury or death associated with a vaccine
p.001359: administered before the effective date of this part if compensation has been paid under this subtitle for 3500
p.001359: petitions for such injuries or deaths.
p.001359: (2) Only one petition may be filed with respect to each ad- ministration of a vaccine. A covered vaccine administered
p.001359: to a pregnant woman shall constitute more than one administra- tion, one to the mother and one to each child (as
p.001359: such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.
p.001359:
p.001359:
p.001359:
p.001359: January 30, 2020
p.001359: 3 So in law. Probably should be followed by a comma.
p.001359: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
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p.001361: January 30, 2020
p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
p.001361: (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a
p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
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p.001361: vaccine-related injury or death,
p.001361: (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records
p.001361: (including all physicians’ and nurses’ notes and test results), vaccination records associated with the
p.001361: vaccine allegedly causing the in- jury, pre- and post-injury physician or clinic records (including all relevant
p.001361: growth charts and test results), all post-injury in- patient and outpatient records (including all
p.001361: provider notes, test results, and medication records), if applicable, a death cer- tificate, and if applicable,
p.001361: autopsy results, and
p.001361: (3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the
p.001361: petitioner and the reasons for their unavailability.
p.001361: (d) ADDITIONAL INFORMATION.—A petition may also include other available relevant medical records relating to the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
p.001361: (e) SCHEDULE.—The petitioner shall submit in accordance with a schedule set by the special master assigned to the
p.001361: petition assess- ments, evaluations, and prognoses and such other records and doc- uments as are reasonably
p.001361: necessary for the determination of the amount of compensation to be paid to, or on behalf of, the
p.001361: person who suffered such injury or who died from the administration of the vaccine.
p.001361: (f) MATERNAL IMMUNIZATION.—
p.001361: (1) IN GENERAL.—Notwithstanding any other provision of law, for purposes of this subtitle, both a woman
p.001361: who received a covered vaccine while pregnant and any child who was in utero at the time such woman
p.001361: received the vaccine shall be considered persons to whom the covered vaccine was adminis- tered and persons
p.001361: who received the covered vaccine.
p.001361: (2) DEFINITION.—As used in this subsection, the term ‘‘child’’ shall have the meaning given that term by
p.001361: subsections
p.001361: (a) and (b) of section 8 of title 1, United States Code, except that, for purposes of this subsection, such
p.001361: section 8 shall be ap- plied as if the term ‘‘include’’ in subsection (a) of such section were replaced with
p.001361: the term ‘‘mean’’.
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p.001361: January 30, 2020
p.001361:
p.001361: JURISDICTION
p.001361: SEC. 2112. ø300aa–12¿ (a) GENERAL RULE.—The United States Claims Court and the United States Claims Court special
p.001361: masters shall, in accordance with this section, have jurisdiction over pro- ceedings to determine if a
p.001361: petitioner under section 2111 is entitled to compensation under the Program and the amount of such com-
p.001361: pensation. The United States Claims Court may issue and enforce such orders as the court deems necessary
p.001361: to assure the prompt payment of any compensation awarded.
p.001361: (b) PARTIES.—
p.001361: (1) In all proceedings brought by the filing of a petition under section 2111(b), the Secretary shall be
p.001361: named as the re-
p.001361: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001361:
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p.001361:
p.001363: 1363
p.001363: PUBLIC HEALTH SERVICE ACT
p.001363: Sec. 2112
p.001363:
p.001363: spondent, shall participate, and shall be represented in accord- ance with section 518(a) of title 28, United States
p.001363: Code.
...

p.001383: of title 5, United States Code, or otherwise, to any person except—
p.001383: (A) the person who received the vaccine, or
p.001383: (B) the legal representative of such person.
p.001383: (2) For purposes of paragraph (1), the term ‘‘information which may identify an individual’’ shall be limited
p.001383: to the name, street address, and telephone number of the person who re- ceived the vaccine and of that
p.001383: person’s legal representative and the medical records of such person relating to the administra- tion of the
p.001383: vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider
p.001383: who administered the vaccine, the date of the vaccination, or information concerning any reported illness,
p.001383: disability, injury, or condition resulting from the administration of the vaccine, any symptom or
p.001383: manifestation of such illness, disability, in- jury, or condition, or death resulting from the
p.001383: administration of the vaccine.
p.001383: (3) Except as provided in paragraph (1), all information re- ported under this section shall be available to the
p.001383: public.
p.001383: VACCINE INFORMATION
p.001383: SEC. 2126. ø300aa–26¿ (a) GENERAL RULE.—Not later than 1 year after the effective date of this part,
p.001383: the Secretary shall de- velop and disseminate vaccine information materials for distribu- tion by health
p.001383: care providers to the legal representatives of any child or to any other individual receiving a vaccine set
p.001383: forth in the Vaccine Injury Table. Such materials shall be published in the Fed- eral Register and may be revised.
p.001383: (b) DEVELOPMENT AND REVISION OF MATERIALS.—Such mate- rials shall be developed or revised—
p.001383:
p.001383:
p.001383:
p.001383:
p.001383: January 30, 2020
p.001383: 25 Effective December 22, 1987.
p.001383: 26 Effective December 22, 1987.
p.001383:
p.001383:
p.001383: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001383:
p.001383:
p.001383:
p.001383:
p.001383:
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p.001383:
p.001383: Sec. 2127 PUBLIC HEALTH SERVICE ACT 1384
p.001383:
p.001383: (1) after notice to the public and 60 days of comment thereon, and
p.001383: (2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers
p.001383: and par- ent organizations, the Centers for Disease Control and Preven- tion, and the Food and Drug Administration.
p.001383: (c) INFORMATION REQUIREMENTS.—The information in such ma- terials shall be based on available data and
p.001383: information, shall be presented in understandable terms and shall include—
p.001383: (1) a concise description of the benefits of the vaccine,
p.001383: (2) a concise description of the risks associated with the vaccine,
p.001383: (3) a statement of the availability of the National Vaccine Injury Compensation Program, and
p.001383: (4) such other relevant information as may be determined by the Secretary.
p.001383: (d) HEALTH CARE PROVIDER DUTIES.—On and after a date de- termined by the Secretary which is—
p.001383: (1) after the Secretary develops the information materials required by subsection (a), and
p.001383: (2) not later than 6 months after the date such materials are published in the Federal Register,
p.001383: each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to
p.001383: the legal representatives of any child or to any other individual to whom such provider in- tends to
p.001383: administer such vaccine a copy of the information mate- rials developed pursuant to subsection (a),
p.001383: supplemented with vis- ual presentations or oral explanations, in appropriate cases. Such materials shall be
p.001383: provided prior to the administration of such vac- cine.
p.001383: MANDATE FOR SAFER CHILDHOOD VACCINES
p.001383: SEC. 2127. ø300aa–27¿ (a) GENERAL RULE.—In the administra- tion of this subtitle and other pertinent laws under the
p.001383: jurisdiction of the Secretary, the Secretary shall—
p.001383: (1) promote the development of childhood vaccines that re- sult in fewer and less serious adverse reactions than those
p.001383: vac- cines on the market on the effective date of this part 27 and promote the refinement of such vaccines,
p.001383: and
p.001383: (2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to,
p.001383: the licensing, manufacturing, processing, testing, labeling, warning, use in- structions, distribution,
p.001383: storage, administration, field surveil- lance, adverse reaction reporting, and recall of reactogenic lots or
p.001383: batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.
p.001383: (b) TASK FORCE.—
p.001383: (1) The Secretary shall establish a task force on safer childhood vaccines which shall consist of the
p.001383: Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and
p.001383: the Director of the Centers for Disease Control.
p.001383:
p.001383:
p.001383:
p.001383: January 30, 2020
p.001383: 27 Effective December 22, 1987.
p.001383:
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p.001391:
p.001391: January 30, 2020
p.001391: percent’’ for any month after the 18th month of continuation coverage described in clause (i) or (ii) of
p.001391: paragraph (2)(A).
p.001391: (4) NO REQUIREMENT OF INSURABILITY.—The coverage may not be conditioned upon, or discriminate on the basis
p.001391: of lack of, evidence of insurability.
p.001391: (5) CONVERSION OPTION.—In the case of a qualified bene- ficiary whose period of continuation coverage
p.001391: expires under paragraph (2)(A), the plan must, during the 180-day period ending on such expiration date,
p.001391: provide to the qualified bene- ficiary the option of enrollment under a conversion health plan otherwise generally
p.001391: available under the plan.
p.001391: SEC. 2203. ø300bb–3¿ QUALIFYING EVENT.
p.001391: For purposes of this title, the term ‘‘qualifying event’’ means, with respect to any covered employee,
p.001391: any of the following events which, but for the continuation coverage required under this title, would
p.001391: result in the loss of coverage of a qualified beneficiary:
p.001391: (1) The death of the covered employee.
p.001391: (2) The termination (other than by reason of such employ- ee’s gross misconduct), or reduction of hours, of the
p.001391: covered employee’s employment.
p.001391: (3) The divorce or legal separation of the covered employee from the employee’s spouse.
p.001391: (4) The covered employee becoming entitled to benefits under title XVIII of the Social Security Act.
p.001391: (5) A dependent child ceasing to be a dependent child under the generally applicable requirements of the plan.
p.001391: SEC. 2204. ø300bb–4¿ APPLICABLE PREMIUM.
p.001391: For purposes of this title—
p.001391: (1) IN GENERAL.—The term ‘‘applicable premium’’ means, with respect to any period of continuation coverage of
p.001391: qualified beneficiaries, the cost to the plan for such period of the cov- erage for similarly situated
p.001391: beneficiaries with respect to whom a qualifying event has not occurred (without regard to whether such cost is paid by
p.001391: the employer or employee).
p.001391: (2) SPECIAL RULE FOR SELF-INSURED PLANS.—To the extent that a plan is a self-insured plan—
p.001391: (A) IN GENERAL.—Except as provided in subparagraph (B), the applicable premium for any period of continuation coverage
p.001391: of qualified beneficiaries shall be equal to a rea- sonable estimate of the cost of providing coverage for such
p.001391: period for similarly situated beneficiaries which—
p.001391: (i) is determined on an actuarial basis, and
p.001391: (ii) takes into account such factors as the Sec- retary may prescribe in regulations.
p.001391: (B) DETERMINATION ON BASIS OF PAST COST.—If a plan administrator elects to have this subparagraph apply,
p.001391: the applicable premium for any period of continuation cov- erage of qualified beneficiaries shall be equal to—
p.001391: (i) the cost to the plan for similarly situated bene- ficiaries for the same period occurring during the pre- ceding
p.001391: determination period under paragraph (3), ad- justed by
p.001391: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001391:
p.001391:
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p.001393: (1) REQUIREMENT.—The requirement of this paragraph, with respect to a group health plan for plan years
p.001393: beginning after the date of the enactment of this Act, is that the group health plan not reduce its coverage of the
p.001393: costs of pediatric vaccines (as defined under sec- tion 1928(h)(6) of the Social Security Act) below the coverage it
p.001393: provided as of May 1, 1993.
p.001393: (2) ENFORCEMENT.—For purposes of section 2207 of the Public Health Service Act, the re- quirement of paragraph (1) is
p.001393: deemed a requirement of title XXII of such Act.
p.001393: 6 So in law. The word ‘‘section’’ does not appear. See section 102(d) of Public Law 104–191 (110 Stat.
p.001393: 1978).
p.001393: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001393:
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p.001393:
p.001393:
p.001395: 1395
p.001395: PUBLIC HEALTH SERVICE ACT
p.001395: Sec. 2302
p.001395:
p.001395: cluding as an employee defined in section 401(c)(1) of the Inter- nal Revenue Code of 1986).
p.001395: (3) QUALIFIED BENEFICIARY.—
p.001395: (A) IN GENERAL.—The term ‘‘qualified beneficiary’’ means, with respect to a covered employee under a
p.001395: group health plan, any other individual who, on the day before the qualifying event for that employee,
p.001395: is a beneficiary under the plan—
p.001395: (i) as the spouse of the covered employee, or
p.001395: (ii) as the dependent child of the employee.
p.001395: Such term shall also include a child who is born to or placed for adoption with the covered employee
p.001395: during the period of continuation coverage under this title. 7
p.001395: (B) SPECIAL RULE FOR TERMINATIONS AND REDUCED EMPLOYMENT.—In the case of a qualifying event described
p.001395: in section 2203(2), the term ‘‘qualified beneficiary’’ includes the covered employee.
p.001395: (4) PLAN ADMINISTRATOR.—The term ‘‘plan administrator’’ has the meaning given the term ‘‘administrator’’
p.001395: by section 3(16)(A) of the Employee Retirement Income Security Act of 1974.
p.001395: TITLE XXIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001395: PART A—ADMINISTRATION OF RESEARCH PROGRAMS
p.001395: SEC. 2302. ø300cc–1¿ REQUIREMENT OF EXPEDITING AWARDS OF GRANTS AND CONTRACTS FOR RESEARCH.
p.001395: (a) IN GENERAL.—The Secretary shall expedite the award of grants, contracts, and cooperative agreements for
p.001395: research projects relating to acquired immune deficiency syndrome (including such research projects initiated
p.001395: independently of any solicitation by the Secretary for proposals for such research projects).
p.001395: (b) TIME LIMITATIONS WITH RESPECT TO CERTAIN APPLICA-
p.001395: TIONS.—
p.001395: (1) With respect to programs of grants, contracts, and co- operative agreements described in subsection
p.001395: (a), any applica- tion submitted in response to a solicitation by the Secretary for proposals pursuant to such a
p.001395: program—
p.001395: (A) may not be approved if the application is sub- mitted after the expiration of the 3-month period
p.001395: begin- ning on the date on which the solicitation is issued; and
p.001395: (B) shall be awarded, or otherwise finally acted upon, not later than the expiration of the 6-month period
...

p.001447: (B) REQUIRED AGREEMENTS.—An individual may serve on the planning council under paragraph (1) only if the in-
p.001447: dividual agrees that if the individual has a financial inter- est in an entity, if the individual is an employee of a
p.001447: public or private entity, or if the individual is a member of a pub- lic or private organization, and such entity or
p.001447: organization is seeking amounts from a grant under section 2601(a), the individual will not, with respect to the
p.001447: purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the
p.001447: process of selecting entities to receive such amounts for such purpose.
p.001447: (C) COMPOSITION OF COUNCIL.—The following applies regarding the membership of a planning council under
p.001447: paragraph (1):
p.001447: (i) Not less than 33 percent of the council shall be individuals who are receiving HIV-related services
p.001447: pursuant to a grant under section 2601(a), are not offi- cers, employees, or consultants to any entity that re-
p.001447: ceives amounts from such a grant, and do not rep- resent any such entity, and reflect the demographics of the
p.001447: population of individuals with HIV/AIDS as deter- mined under paragraph (4)(A). For purposes of the preceding
p.001447: sentence, an individual shall be considered to be receiving such services if the individual is a par- ent of, or a
p.001447: caregiver for, a minor child who is receiv- ing such services.
p.001447: (ii) With respect to membership on the planning council, clause (i) may not be construed as having any effect on
p.001447: entities that receive funds from grants under any of parts B through F but do not receive funds from grants
p.001447: under section 2601(a), on officers or em- ployees of such entities, or on individuals who rep- resent
p.001447: such entities.
p.001447: (6) GRIEVANCE PROCEDURES.—A planning council under paragraph (1) shall develop procedures for addressing
p.001447: griev- ances with respect to funding under this subpart, including procedures for submitting grievances that
p.001447: cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning
p.001447: council and be consistent with the re- quirements of subsection (c).
p.001447: (7) PUBLIC DELIBERATIONS.—With respect to a planning council under paragraph (1), the following applies:
p.001447: (A) The council may not be chaired solely by an em- ployee of the grantee under section 2601(a).
p.001447: (B) In accordance with criteria established by the Sec- retary:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447: January 30, 2020
p.001447: (i) The meetings of the council shall be open to the public and shall be held only after adequate notice to
p.001447: the public.
p.001447: (ii) The records, reports, transcripts, minutes, agenda, or other documents which were made avail-
p.001447: able to or prepared for or by the council shall be avail-
p.001447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001447:
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p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001475:
p.001475:
p.001475:
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p.001475:
p.001475: Sec. 2613 PUBLIC HEALTH SERVICE ACT 1476
p.001475:
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p.001543: of enrollment under the plan, that the plan has made such election, and
p.001543: (ii) include in such statements a description of the effect of this election.
p.001543: (D) ISSUER NOTICE.—In the case of an election under subparagraph (B) with respect to health insurance
p.001543: cov- erage offered by an issuer in the individual or group group 4 market, the issuer—
p.001543: (i) shall prominently state in any disclosure state- ments concerning the coverage, and to each employer at the
p.001543: time of the offer or sale of the coverage, that the issuer has made such election, and
p.001543: (ii) shall include in such statements a description of the effect of such election.
p.001543: (4) ESTABLISHMENT OF PERIOD.—Periods of creditable cov- erage with respect to an individual shall
p.001543: be established through presentation of certifications described in subsection
p.001543: (e) or in such other manner as may be specified in regulations.
p.001543: (d) EXCEPTIONS.—
p.001543: (1) EXCLUSION NOT APPLICABLE TO CERTAIN NEWBORNS.— Subject to paragraph (4), a group health plan, and a health
p.001543: in- surance issuer offering group or individual health insurance coverage, may not impose any preexisting
p.001543: condition exclusion in the case of an individual who, as of the last day of the 30- day period
p.001543: beginning with the date of birth, is covered under creditable coverage.
p.001543: (2) EXCLUSION NOT APPLICABLE TO CERTAIN ADOPTED CHIL- DREN.—Subject to paragraph (4), a group health plan,
p.001543: and a health insurance issuer offering group or individual health in- surance coverage, may not impose any
p.001543: preexisting condition exclusion in the case of a child who is adopted or placed for adoption before
p.001543: attaining 18 years of age and who, as of the last day of the 30-day period beginning on the date of the adop-
p.001543: tion or placement for adoption, is covered under creditable cov- erage. The previous sentence shall not apply to
p.001543: coverage before the date of such adoption or placement for adoption.
p.001543: (3) EXCLUSION NOT APPLICABLE TO PREGNANCY.—A group health plan, and health insurance issuer offering group or
p.001543: indi- vidual health insurance coverage, may not impose any pre- existing condition exclusion relating to
p.001543: pregnancy as a pre- existing condition.
p.001543: (4) LOSS IF BREAK IN COVERAGE.—Paragraphs (1) and (2) shall no longer apply to an individual after the end of
p.001543: the first
p.001543:
p.001543:
p.001543:
p.001543:
p.001543: January 30, 2020
p.001543: 4 So in law. See amendment made by section 1563(c)(1)(A)(ii)(II) (relating to conforming
p.001543: amendments--originally designated as section 1562 and redesignated as section 1563 by section 10107(b)(1)) of Public
p.001543: Law 111–148.
p.001543: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001543:
p.001543:
p.001543:
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p.001543:
p.001545: 1545
p.001545: PUBLIC HEALTH SERVICE ACT
p.001545: Sec. 2704
p.001545:
p.001545: 63-day period during all of which the individual was not cov- ered under any creditable coverage.
p.001545: (e) CERTIFICATIONS AND DISCLOSURE OF COVERAGE.—
...

p.001545: contribution described in subparagraph (C)(ii).
p.001545: (2) FOR DEPENDENT BENEFICIARIES.—
p.001545: (A) IN GENERAL.—If—
p.001545: (i) a group health plan makes coverage available with respect to a dependent of an individual,
p.001545: (ii) the individual is a participant under the plan (or has met any waiting period applicable to becoming a
p.001545: participant under the plan and is eligible to be en- rolled under the plan but for a failure to enroll during
p.001545: a previous enrollment period), and
p.001545: (iii) a person becomes such a dependent of the in- dividual through marriage, birth, or adoption or place- ment for
p.001545: adoption,
p.001545: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001545:
p.001545:
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p.001545:
p.001545:
p.001547: 1547
p.001547: PUBLIC HEALTH SERVICE ACT
p.001547: Sec. 2704
p.001547:
p.001547: the group health plan shall provide for a dependent special enrollment period described in subparagraph (B)
p.001547: during which the person (or, if not otherwise enrolled, the indi- vidual) may be enrolled under the plan
p.001547: as a dependent of the individual, and in the case of the birth or adoption of a child, the spouse of
p.001547: the individual may be enrolled as a dependent of the individual if such spouse is otherwise eli- gible for
p.001547: coverage.
p.001547: (B) DEPENDENT SPECIAL ENROLLMENT PERIOD.—A de- pendent special enrollment period under this subpara-
p.001547: graph shall be a period of not less than 30 days and shall begin on the later of—
p.001547: (i) the date dependent coverage is made available, or
p.001547: (ii) the date of the marriage, birth, or adoption or placement for adoption (as the case may be) described in
p.001547: subparagraph (A)(iii).
p.001547: (C) NO WAITING PERIOD.—If an individual seeks to en- roll a dependent during the first 30 days of such a depend- ent
p.001547: special enrollment period, the coverage of the depend- ent shall become effective—
p.001547: (i) in the case of marriage, not later than the first day of the first month beginning after the date the
p.001547: completed request for enrollment is received;
p.001547: (ii) in the case of a dependent’s birth, as of the date of such birth; or
p.001547: (iii) in the case of a dependent’s adoption or place- ment for adoption, the date of such adoption or place- ment for
p.001547: adoption.
p.001547: (3) SPECIAL RULES FOR APPLICATION IN CASE OF MEDICAID AND CHIP.—
p.001547: (A) IN GENERAL.—A group health plan, and a health insurance issuer offering group health insurance
p.001547: coverage in connection with a group health plan, shall permit an employee who is eligible, but not
p.001547: enrolled, for coverage under the terms of the plan (or a dependent of such an em- ployee if the dependent is
p.001547: eligible, but not enrolled, for cov- erage under such terms) to enroll for coverage under the terms of the
p.001547: plan if either of the following conditions is met:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
p.001547:
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p.001547: (i) TERMINATION OF MEDICAID OR CHIP COV- ERAGE.—The employee or dependent is covered under a
p.001547: Medicaid plan under title XIX of the Social Security Act or under a State child health plan under title XXI of such Act
p.001547: and coverage of the employee or dependent under such a plan is terminated as a result of loss of eligibility
p.001547: for such coverage and the employee requests coverage under the group health plan (or health insur- ance coverage) not
p.001547: later than 60 days after the date of termination of such coverage.
p.001547: (ii) ELIGIBILITY FOR EMPLOYMENT ASSISTANCE UNDER MEDICAID OR CHIP.—The employee or depend- ent
p.001547: becomes eligible for assistance, with respect to cov- erage under the group health plan or health insurance
p.001547: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001547: Sec. 2704 PUBLIC HEALTH SERVICE ACT 1548
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p.001547: January 30, 2020
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p.001547: coverage, under such Medicaid plan or State child health plan (including under any waiver or demonstra- tion
p.001547: project conducted under or in relation to such a plan), if the employee requests coverage under the
p.001547: group health plan or health insurance coverage not later than 60 days after the date the employee or
p.001547: de- pendent is determined to be eligible for such assist- ance.
p.001547: (B) COORDINATION WITH MEDICAID AND CHIP.—
p.001547: (i) OUTREACH TO EMPLOYEES REGARDING AVAIL- ABILITY OF MEDICAID AND CHIP COVERAGE.—
p.001547: (I) IN GENERAL.—Each employer that main- tains a group health plan in a State that provides medical assistance
p.001547: under a State Medicaid plan under title XIX of the Social Security Act, or child health assistance under a
p.001547: State child health plan under title XXI of such Act, in the form of pre- mium assistance for the
p.001547: purchase of coverage under a group health plan, shall provide to each employee a written notice informing
p.001547: the employee of potential opportunities then currently available in the State in which the employee resides for pre-
p.001547: mium assistance under such plans for health cov- erage of the employee or the employee’s depend- ents. For
p.001547: purposes of compliance with this sub- clause, the employer may use any State-specific model notice developed
p.001547: in accordance with section 701(f)(3)(B)(i)(II) of the Employee Retirement In- come Security Act of
p.001547: 1974 (29 U.S.C. 1181(f)(3)(B)(i)(II)).
p.001547: (II) OPTION TO PROVIDE CONCURRENT WITH PROVISION OF PLAN MATERIALS TO EMPLOYEE.—An
p.001547: employer may provide the model notice applicable to the State in which an employee resides concur- rent with the
p.001547: furnishing of materials notifying the employee of health plan eligibility, concurrent with materials
p.001547: provided to the employee in con- nection with an open season or election process conducted under the
p.001547: plan, or concurrent with the furnishing of the summary plan description as provided in section 104(b) of the
p.001547: Employee Retire- ment Income Security Act of 1974.
p.001547: (ii) DISCLOSURE ABOUT GROUP HEALTH PLAN BENE- FITS TO STATES FOR MEDICAID AND CHIP ELIGIBLE INDI-
p.001547: VIDUALS.—In the case of an enrollee in a group health plan who is covered under a Medicaid plan of a State under title
p.001547: XIX of the Social Security Act or under a State child health plan under title XXI of such Act, the
p.001547: plan administrator of the group health plan shall disclose to the State, upon request, information about
p.001547: the benefits available under the group health plan in sufficient specificity, as determined under
p.001547: regulations of the Secretary of Health and Human Services in con- sultation with the Secretary that require use
p.001547: of the
p.001547: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001547:
p.001549: 1549
p.001549: PUBLIC HEALTH SERVICE ACT
p.001549: Sec. 2705
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p.001549: January 30, 2020
p.001549: model coverage coordination disclosure form developed under section 311(b)(1)(C) of the Children’s Health In- surance
p.001549: Reauthorization Act of 2009, so as to permit the State to make a determination (under paragraph (2)(B),
p.001549: (3), or (10) of section 2105(c) of the Social Secu- rity Act or otherwise) concerning the cost-effectiveness of the
p.001549: State providing medical or child health assist- ance through premium assistance for the purchase of
p.001549: coverage under such group health plan and in order for the State to provide supplemental benefits required
p.001549: under paragraph (10)(E) of such section or other au- thority.
p.001549: (g) USE OF AFFILIATION PERIOD BY HMOS AS ALTERNATIVE TO
p.001549: PREEXISTING CONDITION EXCLUSION.—
p.001549: (1) IN GENERAL.—A health maintenance organization which offers health insurance coverage in connection
p.001549: with a group health plan and which does not impose any preexisting condition exclusion allowed under
p.001549: subsection (a) with respect to any particular coverage option may impose an affiliation pe- riod for such coverage
p.001549: option, but only if—
p.001549: (A) such period is applied uniformly without regard to any health status-related factors; and
p.001549: (B) such period does not exceed 2 months (or 3 months in the case of a late enrollee).
p.001549: (2) AFFILIATION PERIOD.—
p.001549: (A) DEFINED.—For purposes of this title, the term ‘‘af- filiation period’’ means a period which, under the terms of the
p.001549: health insurance coverage offered by the health main- tenance organization, must expire before the health insur- ance
p.001549: coverage becomes effective. The organization is not required to provide health care services or benefits during
p.001549: such period and no premium shall be charged to the par- ticipant or beneficiary for any coverage during
p.001549: the period.
p.001549: (B) BEGINNING.—Such period shall begin on the enroll- ment date.
p.001549: (C) RUNS CONCURRENTLY WITH WAITING PERIODS.—An affiliation period under a plan shall run concurrently with any
p.001549: waiting period under the plan.
...

p.001551: defined for the purposes of applying the regulations promulgated by the Secretary under part C of title
p.001551: XI of the Social Security Act and section 264 of the Health Insurance Portability and Accountability Act
p.001551: of 1996, as may be revised from time to time) consistent with subsection (a).
p.001551: (B) LIMITATION.—For purposes of subparagraph (A), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request only the minimum
p.001551: amount of in- formation necessary to accomplish the intended purpose.
p.001551: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request, but not require, that a
p.001551: participant or bene- ficiary undergo a genetic test if each of the following conditions is met:
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p.001551: January 30, 2020
p.001551: (A) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal
p.001551: Regula- tions, or equivalent Federal regulations, and any applica- ble State or local law or regulations
p.001551: for the protection of human subjects in research.
p.001551: (B) The plan or issuer clearly indicates to each partici- pant or beneficiary, or in the case of a minor child, to the
p.001551: legal guardian of such beneficiary, to whom the request is made that—
p.001551: (i) compliance with the request is voluntary; and
p.001551: (ii) non-compliance will have no effect on enroll- ment status or premium or contribution amounts.
p.001551: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001551: (D) The plan or issuer notifies the Secretary in writing that the plan or issuer is conducting activities pursuant to
p.001551: the exception provided for under this paragraph, including a description of the activities conducted.
p.001551: (E) The plan or issuer complies with such other condi- tions as the Secretary may by regulation require for activi-
p.001551: ties conducted under this paragraph.
p.001551: (d) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001551: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering health insurance coverage in
p.001551: connection
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001551: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1552
p.001551:
p.001551: with a group health plan, shall not request, require, or pur- chase genetic information for underwriting
p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
p.001551: surance issuer offering health insurance coverage in connection with a group health plan, shall not request,
...

p.001555: or issuer. Nothing in this section shall be con- strued as preventing a group health plan, a health
p.001555: insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance
p.001555: measures.
p.001555: (b) INDIVIDUALS.—The provisions of section 1558 of the Patient Protection and Affordable Care Act (relating to
p.001555: non-discrimination) shall apply with respect to a group health plan or health insurance issuer offering group or
p.001555: individual health insurance coverage.
p.001555: SEC. 2707. ø300gg–6¿ COMPREHENSIVE HEALTH INSURANCE COV- ERAGE.
p.001555: (a) COVERAGE FOR ESSENTIAL HEALTH BENEFITS PACKAGE.—A health insurance issuer that offers health insurance
p.001555: coverage in the individual or small group market shall ensure that such coverage includes the essential
p.001555: health benefits package required under sec- tion 1302(a) of the Patient Protection and Affordable Care Act.
p.001555: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001555:
p.001557: 1557
p.001557: PUBLIC HEALTH SERVICE ACT
p.001557: Sec. 2709
p.001557:
p.001557: (b) COST-SHARING UNDER GROUP HEALTH PLANS.—A group health plan shall ensure that any annual
p.001557: cost-sharing imposed under the plan does not exceed the limitations provided for under paragraph (1) of
p.001557: section 1302(c).
p.001557: (c) CHILD-ONLY PLANS.—If a health insurance issuer offers health insurance coverage in any level of
p.001557: coverage specified under section 1302(d) of the Patient Protection and Affordable Care Act, the issuer
p.001557: shall also offer such coverage in that level as a plan in which the only enrollees are individuals
p.001557: who, as of the beginning of a plan year, have not attained the age of 21.
p.001557: (d) DENTAL ONLY.—This section shall not apply to a plan de- scribed in section 1302(d)(2)(B)(ii)(I).
p.001557: SEC. 2708. ø300gg–7¿ PROHIBITION ON EXCESSIVE WAITING PERIODS.
p.001557: A group health plan and a health insurance issuer offering group health insurance coverage shall not apply any
p.001557: waiting period (as defined in section 2704(b)(4)) that exceeds 90 days.
p.001557: SEC. 2709. ø300gg–8¿ COVERAGE FOR INDIVIDUALS PARTICIPATING IN APPROVED CLINICAL TRIALS. 6
p.001557: (a) COVERAGE.—
p.001557: (1) IN GENERAL.—If a group health plan or a health insur- ance issuer offering group or individual health
p.001557: insurance cov- erage provides coverage to a qualified individual, then such plan or issuer—
p.001557: (A) may not deny the individual participation in the clinical trial referred to in subsection (b)(2);
p.001557: (B) subject to subsection (c), may not deny (or limit or impose additional conditions on) the coverage of
p.001557: routine patient costs for items and services furnished in connection with participation in the trial; and
p.001557: (C) may not discriminate against the individual on the basis of the individual’s participation in such trial.
p.001557: (2) ROUTINE PATIENT COSTS.—
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p.001561: January 30, 2020
p.001561:
p.001561: scribed in subsection (a)(1) or (a)(2) or a guideline under sub- section (a)(3) is issued and the plan year
p.001561: with respect to which the requirement described in subsection (a) is effective with re- spect to the service
p.001561: described in such recommendation or guideline.
p.001561: (2) MINIMUM.—The interval described in paragraph (1) shall not be less than 1 year.
p.001561: (c) VALUE-BASED INSURANCE DESIGN.—The Secretary may de- velop guidelines to permit a group health plan and a
p.001561: health insur- ance issuer offering group or individual health insurance coverage to utilize value-based
p.001561: insurance designs.
p.001561: SEC. 2714. ø300gg–14¿ EXTENSION OF DEPENDENT COVERAGE.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage that provides dependent coverage of children shall continue to make such coverage available for
p.001561: an adult child until the child turns 26 years of age. Nothing in this section shall require a health plan or a
p.001561: health insurance issuer described in the preceding sentence to make coverage available for a child of a
p.001561: child receiving dependent coverage.
p.001561: (b) REGULATIONS.—The Secretary shall promulgate regulations to define the dependents to which coverage shall be made
p.001561: available under subsection (a).
p.001561: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to modify the definition of ‘‘dependent’’
p.001561: as used in the In- ternal Revenue Code of 1986 with respect to the tax treatment of the cost of coverage.
p.001561: SEC. 2715. ø300gg–15¿ DEVELOPMENT AND UTILIZATION OF UNIFORM EXPLANATION OF COVERAGE DOCUMENTS AND STAND-
p.001561: ARDIZED DEFINITIONS.
p.001561: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Patient Protection and
p.001561: Affordable Care Act, the Secretary shall develop standards for use by a group health plan and a health
p.001561: insurance issuer offering group or individual health insurance coverage, in compiling and providing to
p.001561: applicants, en- rollees, and policyholders or certificate holders a summary of bene- fits and coverage explanation
p.001561: that accurately describes the benefits and coverage under the applicable plan or coverage. In developing such
p.001561: standards, the Secretary shall consult with the National Asso- ciation of Insurance Commissioners (referred to in
p.001561: this section as the ‘‘NAIC’’), a working group composed of representatives of health
p.001561: insurance-related consumer advocacy organizations, health insurance issuers, health care professionals,
...

p.001571: layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of
p.001571: immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section
p.001571: 1867(e)(1)(A) of the Social Security Act.
p.001571: (B) EMERGENCY SERVICES.—The term ‘‘emergency services’’ means, with respect to an emergency medical
p.001571: condition—
p.001571: (i) a medical screening examination (as required under section 1867 of the Social Security Act) that is
p.001571: within the capability of the emergency department of a hospital, including ancillary services routinely avail-
p.001571: able to the emergency department to evaluate such emergency medical condition, and
p.001571: (ii) within the capabilities of the staff and facili- ties available at the hospital, such further medical ex-
p.001571: amination and treatment as are required under sec- tion 1867 of such Act to stabilize the patient.
p.001571: (C) STABILIZE.—The term ‘‘to stabilize’’, with respect to an emergency medical condition (as defined in subpara-
p.001571: graph (A)), has the meaning give in section 1867(e)(3) of the Social Security Act (42 U.S.C. 1395dd(e)(3)).
p.001571: (c) ACCESS TO PEDIATRIC CARE.—
p.001571: (1) PEDIATRIC CARE.—In the case of a person who has a child who is a participant, beneficiary, or
p.001571: enrollee under a group health plan, or health insurance coverage offered by a health insurance issuer in
p.001571: the group or individual market, if the plan or issuer requires or provides for the designation of a
p.001571: participating primary care provider for the child, the plan or issuer shall permit such person to designate
p.001571: a physician (allopathic or osteopathic) who specializes in pediatrics as the child’s primary care
p.001571: provider if such provider participates in the network of the plan or issuer.
p.001571: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued to waive any exclusions of coverage under the
p.001571: terms and conditions of the plan or health insurance coverage with respect to coverage of pediatric care.
p.001571: (d) PATIENT ACCESS TO OBSTETRICAL AND GYNECOLOGICAL CARE.—
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p.001571: January 30, 2020
p.001571: (1) GENERAL RIGHTS.—
p.001571: (A) DIRECT ACCESS.—A group health plan, or health insurance issuer offering group or individual health insur-
p.001571: ance coverage, described in paragraph (2) may not require authorization or referral by the plan, issuer, or any person
p.001571: (including a primary care provider described in paragraph (2)(B)) in the case of a female participant,
p.001571: beneficiary, or enrollee who seeks coverage for obstetrical or gynecological care provided by a participating
p.001571: health care professional who specializes in obstetrics or gynecology. Such profes-
p.001571: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001571:
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p.001573: 1573
p.001573: PUBLIC HEALTH SERVICE ACT
p.001573: Sec. 2725
p.001573:
p.001573: sional shall agree to otherwise adhere to such plan’s or issuer’s policies and procedures, including
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p.001573: (A), by a participating health care professional who specializes in obstetrics or gynecology as the
p.001573: authorization of the primary care pro- vider.
p.001573: (2) APPLICATION OF PARAGRAPH.—A group health plan, or health insurance issuer offering group or individual
p.001573: health in- surance coverage, described in this paragraph is a group health plan or coverage that—
p.001573: (A) provides coverage for obstetric or gynecologic care;
p.001573: and
p.001573: (B) requires the designation by a participant, bene-
p.001573: ficiary, or enrollee of a participating primary care provider.
p.001573: (3) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued to—
p.001573: (A) waive any exclusions of coverage under the terms and conditions of the plan or health insurance
p.001573: coverage with respect to coverage of obstetrical or gynecological care; or
p.001573: (B) preclude the group health plan or health insurance issuer involved from requiring that the obstetrical or gyne-
p.001573: cological provider notify the primary care health care pro- fessional or the plan or issuer of treatment decisions.
p.001573: SEC. 2725. 10 ø300gg–25¿ STANDARDS RELATING TO BENEFITS FOR MOTHERS AND NEWBORNS.
p.001573: (a) REQUIREMENTS FOR MINIMUM HOSPITAL STAY FOLLOWING BIRTH.—
p.001573: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001573: insurance cov- erage, may not—
p.001573: (A) except as provided in paragraph (2)—
p.001573: (i) restrict benefits for any hospital length of stay in connection with childbirth for the mother or new- born
p.001573: child, following a normal vaginal delivery, to less than 48 hours, or
p.001573: (ii) restrict benefits for any hospital length of stay in connection with childbirth for the mother or new-
p.001573: born child, following a cesarean section, to less than 96 hours, or
p.001573: (B) require that a provider obtain authorization from the plan or the issuer for prescribing any length of stay
p.001573: re-
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p.001573: January 30, 2020
p.001573: 10 The placement of this section and succeeding sections 2726, 2727, and 2728 here, versus after section
p.001573: 2724, is ambiguous insofar as these sections at the time of their redesignation from sections 2704–2708 were not
p.001573: explicitly moved to follow section 2724, yet the failure to place them after section 2724 results in
p.001573: these sections not following ordinary sequential numbering.
p.001573: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001573: Sec. 2725 PUBLIC HEALTH SERVICE ACT 1574
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p.001573: January 30, 2020
p.001573:
p.001573: quired under subparagraph (A) (without regard to para- graph (2)).
p.001573: (2) EXCEPTION.—Paragraph (1)(A) shall not apply in con- nection with any group health plan or health insurance
p.001573: issuer in any case in which the decision to discharge the mother or her newborn child prior to the
p.001573: expiration of the minimum length of stay otherwise required under paragraph (1)(A) is made by an attending
p.001573: provider in consultation with the moth- er.
p.001573: (b) PROHIBITIONS.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001573: insurance coverage, may not—
p.001573: (1) deny to the mother or her newborn child eligibility, or continued eligibility, to enroll or to
p.001573: renew coverage under the terms of the plan or coverage, solely for the purpose of avoiding the requirements of this
p.001573: section;
p.001573: (2) provide monetary payments or rebates to mothers to encourage such mothers to accept less than the minimum
p.001573: pro- tections available under this section;
p.001573: (3) penalize or otherwise reduce or limit the reimburse- ment of an attending provider because such
p.001573: provider provided care to an individual participant or beneficiary in accordance with this section;
p.001573: (4) provide incentives (monetary or otherwise) to an at- tending provider to induce such provider to provide
p.001573: care to an individual participant or beneficiary in a manner inconsistent with this section; or
p.001573: (5) subject to subsection (c)(3), restrict benefits for any por- tion of a period within a hospital length of stay
p.001573: required under subsection (a) in a manner which is less favorable than the benefits provided for any
p.001573: preceding portion of such stay.
p.001573: (c) RULES OF CONSTRUCTION.—
p.001573: (1) Nothing in this section shall be construed to require a mother who is a participant or beneficiary—
p.001573: (A) to give birth in a hospital; or
p.001573: (B) to stay in the hospital for a fixed period of time fol- lowing the birth of her child.
p.001573: (2) This section shall not apply with respect to any group health plan, or any health insurance issuer
p.001573: offering group or individual health insurance coverage, which does not provide benefits for hospital
p.001573: lengths of stay in connection with child- birth for a mother or her newborn child.
p.001573: (3) Nothing in this section shall be construed as preventing a group health plan or health insurance issuer
p.001573: from imposing deductibles, coinsurance, or other cost-sharing in relation to benefits for hospital lengths
p.001573: of stay in connection with child- birth for a mother or newborn child under the plan (or under health
p.001573: insurance coverage offered in connection with a group health plan), except that such coinsurance or other
p.001573: cost-shar- ing for any portion of a period within a hospital length of stay required under subsection (a) may not be
p.001573: greater than such co- insurance or cost-sharing for any preceding portion of such stay.
p.001573: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001573:
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p.001573:
p.001573:
p.001575: 1575
p.001575: PUBLIC HEALTH SERVICE ACT
p.001575: Sec. 2726
p.001575:
p.001575: (d) NOTICE.—A group health plan under this part shall comply with the notice requirement under section 711(d) of
p.001575: the Employee Retirement Income Security Act of 1974 with respect to the re- quirements of this section
p.001575: as if such section applied to such plan.
p.001575: (e) LEVEL AND TYPE OF REIMBURSEMENTS.—Nothing in this section shall be construed to prevent a group
p.001575: health plan or a health insurance issuer offering group or individual health insur- ance coverage from
p.001575: negotiating the level and type of reimburse- ment with a provider for care provided in accordance with this sec-
p.001575: tion.
p.001575: (f) PREEMPTION; EXCEPTION FOR HEALTH INSURANCE COVERAGE IN CERTAIN STATES.—
p.001575: (1) IN GENERAL.—The requirements of this section shall not apply with respect to health insurance coverage if
p.001575: there is a State law (as defined in section 2723(d)(1)) for a State that regulates such coverage that is
...

p.001583: for mental health conditions, as defined under the terms of the plan and in accordance with applicable
p.001583: Federal and State law.
p.001583: (5) SUBSTANCE USE DISORDER BENEFITS.—The term ‘‘sub- stance use disorder benefits’’ means benefits with
p.001583: respect to services for substance use disorders, as defined under the terms of the plan and in
p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
p.001583:
p.001583:
p.001583:
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p.001583:
p.001583:
p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
p.001585: (2) DEPENDENT CHILD DESCRIBED.—A dependent child de- scribed in this paragraph is, with respect to a
p.001585: group health plan or individual health insurance coverage, a beneficiary under the plan who—
p.001585: (A) is a dependent child, under the terms of the plan or coverage, of a participant or beneficiary under the
p.001585: plan or coverage; and
p.001585:
p.001585:
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p.001585:
p.001585:
p.001585: January 30, 2020
p.001585: 12 Section 2706 (prior to its redesignation as 2727 by Public Law 111–148) was added by sub- section (a) of section
p.001585: 903 of the Departments of Labor, Health and Human Services, and Edu- cation, and Related Agencies
p.001585: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–438).
p.001585: Subsection (c) of such section 903 concerns effec- tive dates, and paragraph (1) of the subsection provides as follows:
p.001585: ‘‘(1) GROUP PLANS.—
p.001585: ‘‘(A) IN GENERAL.—The amendment made by subsection (a) shall apply to group health plans for plan years
p.001585: beginning on or after the date of enactment of this Act.
p.001585: ‘‘(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group
p.001585: health plan maintained pursuant to 1 or more collective bargaining agreements be- tween employee
p.001585: representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining
p.001585: agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment
p.001585: made by subsection
p.001585: (a) shall not be treated as a termination of such collective bargaining agreement.’’.
p.001585: The Public Law was enacted October 21, 1998.
p.001585: 13 So in law.
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001585:
p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
p.001585:
p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
p.001585: (a) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health
p.001585: insurance coverage shall—
p.001585:
p.001585:
p.001585:
p.001585:
p.001585:
p.001585: January 30, 2020
p.001585: (1) not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the
p.001585: plan or cov- erage from informing (or penalize such pharmacy for inform- ing) an enrollee of any
p.001585: differential between the enrollee’s out- of-pocket cost under the plan or coverage with respect to acqui-
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001587: 1587
p.001587: PUBLIC HEALTH SERVICE ACT
p.001587: Sec. 2722
p.001587:
p.001587: sition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or
p.001587: health insurance coverage; and
p.001587: (2) ensure that any entity that provides pharmacy benefits management services under a contract with any such
p.001587: health plan or health insurance coverage does not, with respect to such plan or coverage, restrict,
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p.001609: 1609
p.001609: PUBLIC HEALTH SERVICE ACT
p.001609: Sec. 2753
p.001609:
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p.001609: January 30, 2020
p.001609: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a health insurance issuer offering health insurance
p.001609: coverage in the individual market may request, but not require, that an in- dividual or a family member of such
p.001609: individual undergo a ge- netic test if each of the following conditions is met:
p.001609: (A) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal
p.001609: Regula- tions, or equivalent Federal regulations, and any applica- ble State or local law or regulations
p.001609: for the protection of human subjects in research.
p.001609: (B) The issuer clearly indicates to each individual, or in the case of a minor child, to the legal guardian of
p.001609: such child, to whom the request is made that—
p.001609: (i) compliance with the request is voluntary; and
p.001609: (ii) non-compliance will have no effect on enroll- ment status or premium or contribution amounts.
p.001609: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001609: (D) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to
p.001609: the excep- tion provided for under this paragraph, including a de- scription of the activities conducted.
p.001609: (E) The issuer complies with such other conditions as the Secretary may by regulation require for activities
p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
p.001609: information concerning any indi- vidual, such request, requirement, or purchase shall not be considered a
...

p.001613: maintained for its employees by the Government of the United States or by any agency or instrumentality of such
p.001613: Govern- ment.
p.001613: (C) NON-FEDERAL GOVERNMENTAL PLAN.—The term ‘‘non- Federal governmental plan’’ means a governmental plan
p.001613: that is not a Federal governmental plan.
p.001613: (9) HEALTH STATUS-RELATED FACTOR.—The term ‘‘health status-related factor’’ means any of the factors described
p.001613: in sec- tion 2702(a)(1).
p.001613: (10) NETWORK PLAN.—The term ‘‘network plan’’ means health insurance coverage of a health insurance
p.001613: issuer under which the financing and delivery of medical care (including items and services paid for as
p.001613: medical care) are provided, in whole or in part, through a defined set of providers under con- tract with the
p.001613: issuer.
p.001613: (11) PARTICIPANT.—The term ‘‘participant’’ has the mean- ing given such term under section 3(7) of the Employee
p.001613: Retire- ment Income Security Act of 1974.
p.001613: (12) PLACED FOR ADOPTION DEFINED.—The term ‘‘place- ment’’, or being ‘‘placed’’, for adoption, in
p.001613: connection with any
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001613:
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p.001613:
p.001613:
p.001615: 1615
p.001615: PUBLIC HEALTH SERVICE ACT
p.001615: Sec. 2791
p.001615:
p.001615: placement for adoption of a child with any person, means the assumption and retention by such person of
p.001615: a legal obligation for total or partial support of such child in anticipation of adop- tion of such child. The
p.001615: child’s placement with such person ter- minates upon the termination of such legal obligation.
p.001615: (13) PLAN SPONSOR.—The term ‘‘plan sponsor’’ has the meaning given such term under section 3(16)(B) of
p.001615: the Em- ployee Retirement Income Security Act of 1974.
p.001615: (14) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, Puerto Rico,
p.001615: the Virgin Is- lands, Guam, American Samoa, and the Northern Mariana Is- lands.
p.001615: (15) FAMILY MEMBER.—The term ‘‘family member’’ means, with respect to any individual—
p.001615: (A) a dependent (as such term is used for purposes of section 2701(f)(2)) of such individual; and
p.001615: (B) any other individual who is a first-degree, second- degree, third-degree, or fourth-degree relative of such indi-
p.001615: vidual or of an individual described in subparagraph (A).
p.001615: (16) GENETIC INFORMATION.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic information’’ means, with respect to any individual, information about—
p.001615: (i) such individual’s genetic tests,
p.001615: (ii) the genetic tests of family members of such in- dividual, and
p.001615: (iii) the manifestation of a disease or disorder in family members of such individual.
p.001615: (B) INCLUSION OF GENETIC SERVICES AND PARTICIPA- TION IN GENETIC RESEARCH.—Such term includes, with re-
p.001615: spect to any individual, any request for, or receipt of, ge- netic services, or participation in
...

p.001633: (2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as
p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001633:
p.001633:
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p.001633:
p.001635: 1635
p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
p.001635:
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p.001635: January 30, 2020
p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
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p.001647: January 30, 2020
p.001647: SEC. 2901. ø300ii¿ DEFINITIONS.
p.001647: In this title:
p.001647: (1) ADULT WITH A SPECIAL NEED.—The term ‘‘adult with a special need’’ means a person 18 years of age or older
p.001647: who re- quires care or supervision to—
p.001647: (A) meet the person’s basic needs;
p.001647: (B) prevent physical self-injury or injury to others; or
p.001647: (C) avoid placement in an institutional facility.
p.001647: (2) AGING AND DISABILITY RESOURCE CENTER.—The term ‘‘aging and disability resource center’’ means an
p.001647: entity admin- istering a program established by the State, as part of the State’s system of long-term
p.001647: care, to provide a coordinated sys- tem for providing—
p.001647: (A) comprehensive information on available public and private long-term care programs, options, and resources;
p.001647: (B) personal counseling to assist individuals in assess- ing their existing or anticipated long-term care needs, and
p.001647: developing and implementing a plan for long-term care de- signed to meet their specific needs and circumstances; and
p.001647: (C) consumer access to the range of publicly supported long-term care programs for which consumers may be eli-
p.001647: gible, by serving as a convenient point of entry for such programs.
p.001647: (3) CHILD WITH A SPECIAL NEED.—The term ‘‘child with a special need’’ means an individual less than 18
p.001647: years of age who requires care or supervision beyond that required of chil- dren generally to—
p.001647: (A) meet the child’s basic needs; or
p.001647: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001649: PUBLIC HEALTH SERVICE ACT
p.001649: Sec. 2902
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p.001649: (B) prevent physical injury, self-injury, or injury to others.
p.001649: (4) ELIGIBLE STATE AGENCY.—The term ‘‘eligible State agency’’ means a State agency that—
p.001649: (A) administers the State’s program under the Older Americans Act of 1965, administers the State’s
p.001649: program under title XIX of the Social Security Act, or is designated by the Governor of such State to administer
p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
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p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
p.001649: thereby reducing family caregiver strain.
p.001649: (b) AUTHORIZATION.—Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for
p.001649: the pur- poses described in subsection (a) to eligible State agencies for which an application is submitted
p.001649: pursuant to subsection (d).
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p.000017: Director of the Bureau of the Budget, 18 is authorized to make such transfers of funds between
p.000017: appropriations as may be necessary for the continu- ance of transferred functions.
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p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 237 PUBLIC HEALTH SERVICE ACT 52
p.000017:
p.000017: AVAILABILITY OF APPROPRIATIONS
p.000017: SEC. 237. ø238f¿ Appropriations for carrying out the purposes of this Act shall be available for
p.000017: expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and
p.000017: exhibits; printing and binding; transporting in Government- owned automotive equipment, to and from school,
p.000017: children of per- sonnel who have quarters for themselves and their families at sta- tions determined by the
p.000017: Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who
p.000017: escape from any hospital, institution, or station of the Service or from the custody of any officer or employee
p.000017: of the Service, in- cluding rewards for the capture of such prisoners; furnishing, re- pairing, and
p.000017: cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the
p.000017: performance of their official duties; reimbursing officers and employees, subject to regulations of the
p.000017: Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients
p.000017: while such officers or employees are engaged in the performance of their official duties; and maintenance of
p.000017: buildings of the National Institutes of Health.
p.000017: UNAUTHORIZED WEARING OF UNIFORMS
p.000017: SEC. 238. ø238g¿ Except as may be authorized by regulations of the President, the insignia and uniform of
p.000017: commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia
p.000017: or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of
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p.000017: the United States; and
p.000017: (10) in consultation with the Secretary of State, through grant or cooperative agreement, make funds available
p.000017: to public or nonprofit private institutions or agencies in foreign coun- tries in which the Secretary is
p.000017: participating in activities de- scribed under subsection (a) to acquire, lease, construct, alter, or
p.000017: renovate facilities in those countries.
p.000017: (c) The Secretary may provide to personnel appointed or as- signed by the Secretary to serve abroad,
p.000017: allowances and benefits similar to those provided under chapter 9 of title I of the Foreign Service Act
p.000017: of 1980 (22 U.S.C. 4081 et seq.). Leaves of absence for personnel under this subsection shall be on the same basis as
p.000017: that provided under subchapter I of chapter 63 of title 5, United States Code or section 903 of the Foreign
p.000017: Service Act of 1980 (22 U.S.C. 4083), to individuals serving in the Foreign Service.
p.000017: (d) In carrying out immunization programs and other programs in developing countries for the prevention,
p.000017: treatment, and control of infectious diseases, including HIV/AIDS, tuberculosis, and ma- laria, the Director
p.000017: of the Centers for Disease Control and Preven- tion, in coordination with the Coordinator of United States
p.000017: Govern- ment Activities to Combat HIV/AIDS Globally, the National Insti- tutes of Health, national and local
p.000017: government, and other organiza- tions, such as the World Health Organization and the United Na- tions
p.000017: Children’s Fund, shall develop and implement effective strat- egies to improve injection safety, including eliminating
p.000017: unnecessary injections, promoting sterile injection practices and technologies, strengthening the procedures
p.000017: for proper needle and syringe dis- posal, and improving the education and information provided to the public and
p.000017: to health professionals.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 87 PUBLIC HEALTH SERVICE ACT Sec. 308
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p.000017: January 30, 2020
p.000017: GENERAL PROVISIONS RESPECTING EFFECTIVENESS, EFFICIENCY, AND QUALITY OF HEALTH SERVICES
p.000017: SEC. 308. ø242m¿ (a)(1) Not later than March 15 of each year, the Secretary shall submit to the President and
p.000017: Congress the fol- lowing reports:
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p.000101:
p.000101: preventive health service programs from being used on connection with programs assisted through grants under
p.000101: subsection (a).
p.000101: (2) Nothing in this section shall be construed to require any State or any agency or political
p.000101: subdivision of a State to have a preventive health service program which would require any person, who objects to
p.000101: any treatment provided under such a program, to be treated or to have any child or ward treated under such
p.000101: program.
p.000101: (h) The Secretary shall include, as part of the report required by section 1705, a report on the
p.000101: extent of the problems presented by the diseases and conditions referred to in subsection (j) on the
p.000101: amount of funds obligated under grants under subsection (a) in the preceding fiscal year for each of the
p.000101: programs listed in subsection (j); and on the effectiveness of the activities assisted under grants under
p.000101: subsection (a) in controlling such diseases and conditions.
p.000101: (i) The Secretary may provide technical assistance to States, State health authorities, and other public
p.000101: entities in connection with the operation of their preventive health service programs.
p.000101: (j)(1) Except for grants for immunization programs the author- ization of appropriations for which are
p.000101: established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to
p.000101: immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are
p.000101: author- ized to be appropriated such sums as may be necessary. Not more than 10 percent ot the total amount
p.000101: appropriated under the pre- ceding sentence for any fiscal year shall be available for grants under
p.000101: subsection (k)(1) for such fiscal year.
p.000101: (2) For grants under subsection (a) for preventive health serv- ice programs for the provision without charge of
p.000101: immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be
p.000101: appropriated such sums as may be nec- essary.
p.000101: (k)(1) The Secretary may make grants to States, political sub- divisions of States, and other public and
p.000101: nonprofit private entities for—
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p.000101: (A) research into the prevention and control of diseases that may be prevented through vaccination;
p.000101: (B) demonstration projects for the prevention and control of such diseases;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000101: diseases for health professionals (including allied health personnel).
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p.000103: immunization records.
p.000103: (4) CONSIDERATION.—In awarding grants under this sub- section, the Secretary shall consider any
p.000103: reviews or rec- ommendations of the Task Force on Community Preventive Services.
p.000103: (5) EVALUATION.—Not later than 3 years after the date on which a State receives a grant under this subsection, the
p.000103: State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage
p.000103: rates among high- risk populations within the State.
p.000103: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Affordable Health Choices
p.000103: Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program
p.000103: established under this subsection together with recommendations on whether to continue and expand such program.
p.000103: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection, such
p.000103: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000103: SCREENINGS, REFERRALS, AND EDUCATION REGARDING LEAD POISONING
p.000103: SEC. 317A. ø247b–1¿ (a) AUTHORITY FOR GRANTS.—
p.000103: (1) IN GENERAL.—Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease
p.000103: Control and Prevention, may make grants to States and political sub- divisions of States for the
p.000103: initiation and expansion of commu- nity programs designed—
p.000103: (A) to provide, for infants and children—
p.000103: (i) screening for elevated blood lead levels;
p.000103: (ii) referral for treatment of such levels; and
p.000103: (iii) referral for environmental intervention associ- ated with such levels; and
p.000103: (B) to provide education about childhood lead poi- soning.
p.000103: (2) AUTHORITY REGARDING CERTAIN ENTITIES.—With re- spect to a geographic area with a need for activities
p.000103: authorized in paragraph (1), in any case in which neither the State nor the political subdivision in
p.000103: which such area is located has ap- plied for a grant under paragraph (1), the Secretary may make
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: PUBLIC HEALTH SERVICE ACT
p.000105: Sec. 317A
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p.000105: January 30, 2020
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p.000105: title XIX of the Social Security Act for the State involved—
p.000105: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.000105: agreement under the State plan and is qualified to receive payments under such plan; or
p.000105: (B) the applicant will enter into an agreement with a provider under which the provider will provide the
p.000105: service, and the provider has entered into such a participation agreement and is qualified to receive such
p.000105: payments.
p.000105: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.000105: (A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision
p.000105: of services, the requirement established in such paragraph regarding a participation agreement shall be waived by
p.000105: the Secretary if the provider does not, in providing health care services, impose a charge or accept
p.000105: reimbursement avail- able from any third-party payor, including reimbursement under any insurance policy or
p.000105: under any Federal or State health benefits plan.
p.000105: (B) A determination by the Secretary of whether a pro- vider referred to in subparagraph (A) meets the criteria for a
p.000105: waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary dona-
p.000105: tions regarding the provision of services to the public.
p.000105: (c) PRIORITY IN MAKING GRANTS.—In making grants under sub- section (a), the Secretary shall give priority to
p.000105: applications for pro- grams that will serve areas with a high incidence of elevated blood lead levels in infants and
p.000105: children.
p.000105: (d) GRANT APPLICATION.—No grant may be made under sub- section (a), unless an application therefor has
p.000105: been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be
p.000105: submitted in such manner as the Secretary shall prescribe and shall include each of the following:
p.000105: (1) A complete description of the program which is to be provided by or through the applicant.
p.000105: (2) Assurances satisfactory to the Secretary that the pro- gram to be provided under the grant applied
p.000105: for will include educational programs designed to—
p.000105: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: (A) communicate to parents, educators, and local health officials the significance and prevalence of lead
p.000105: poi- soning in infants and children (including the sources of lead exposure, the importance of screening young
p.000105: children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which
p.000105: the program is designed to detect and prevent; and
p.000105: (B) communicate to health professionals and para- professionals updated knowledge concerning lead poisoning and
p.000105: research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning
p.000105: among all socioeconomic groupings; the benefits of ex- panded lead screening; and the therapeutic
p.000105: and other interventions available to prevent and combat lead poi- soning in affected children and families).
p.000105: (3) Assurances satisfactory to the Secretary that the appli- cant will report on a quarterly basis the number of
p.000105: infants and children screened for elevated blood lead levels, the number of infants and children who were found
p.000105: to have elevated blood lead levels, the number and type of medical referrals made for such infants and children,
p.000105: the outcome of such referrals, and other information to measure program effectiveness.
p.000105: (4) Assurances satisfactory to the Secretary that the appli- cant will make such reports respecting the program
p.000105: involved as the Secretary may require.
p.000105: (5) Assurances satisfactory to the Secretary that the appli- cant will coordinate the activities carried out pursuant
p.000105: to sub- section (a) with related activities and services carried out in the State by grantees under title V or
p.000105: XIX of the Social Secu- rity Act.
p.000105: (6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for
p.000105: any period will be so used as to supplement and, to the extent practical, in- crease the level of
p.000105: State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made
p.000105: available for the program for which the grant is to be made and will in no event supplant such State, local,
p.000105: and other non- Federal funds.
p.000105: (7) Assurances satisfactory to the Secretary that the appli- cant will ensure complete and consistent reporting of all
p.000105: blood lead test results from laboratories and health care providers to State and local health departments in
p.000105: accordance with guide- lines of the Centers for Disease Control and Prevention for standardized reporting as
p.000105: described in subsection (m).
p.000105: (8) Such other information as the Secretary may prescribe.
p.000105: (e) RELATIONSHIP TO SERVICES AND ACTIVITIES UNDER OTHER PROGRAMS.—
p.000105: (1) IN GENERAL.—A recipient of a grant under subsection
p.000105: (a) may not make payments from the grant for any service or activity to the extent that payment has been
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p.000107: pertinent to such grant.
p.000107: (j) ANNUAL REPORT.—
p.000107: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000107: January 30, 2020
p.000107:
p.000107: (1) IN GENERAL.—Not later than May 1 of each year, the Secretary shall submit to the Congress a report
p.000107: on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection
p.000107: (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
p.000107: (2) CERTAIN REQUIREMENTS.—Each report under para- graph (1) shall include, in addition to any other
p.000107: information that the Secretary may require, the following information:
p.000107: (A) The number of infants and children screened.
p.000107: (B) Demographic information on the population of in- fants and children screened, including the age and
p.000107: racial or ethnic status of such population.
p.000107: (C) The number of screening sites.
p.000107: (D) A description of the severity of the extent of the blood lead levels of the infants and children
p.000107: screened, ex- pressed in categories of severity.
p.000107: (E) The sources of payment for the screenings.
p.000107: (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from
p.000107: laboratories and health care providers to State and local health departments.
p.000107: (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if
p.000107: any, provided in the report under paragraph (1) preceding the report involved.
p.000107: (k) INDIAN TRIBES.—For purposes of this section, the term ‘‘po- litical subdivision’’ includes Indian tribes.
p.000107: (l) FUNDING.—
p.000107: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000107: be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years
p.000107: 1994 through 2005.
p.000107: (2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts appropriated under paragraph (1) for any fiscal year,
p.000107: the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities
p.000107: described in subsection (a) in addition to the program of grants established in such sub- section.
p.000107: (m) GUIDELINES FOR STANDARDIZED REPORTING.—The Sec- retary, acting through the Director of the Centers for
p.000107: Disease Con- trol and Prevention, shall develop national guidelines for the uni- form reporting of all
p.000107: blood lead test results to State and local health departments.
p.000107: EDUCATION, TECHNOLOGY ASSESSMENT, AND EPIDEMIOLOGY REGARDING LEAD POISONING
p.000107: SEC. 317B. ø247b–3¿ (a) PREVENTION.—
p.000107: (1) PUBLIC EDUCATION.—The Secretary, acting through the Director of the Centers for Disease Control and
p.000107: Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general
p.000107: public on the prevention of lead poisoning in infants and children. In carrying out the pro- gram, the Secretary
p.000107: shall make available information con-
p.000107: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000107:
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p.000109: PUBLIC HEALTH SERVICE ACT
p.000109: Sec. 317B
p.000109:
p.000109: cerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and
p.000109: secondary preventive measures that may be taken to prevent such poisoning.
p.000109: (2) INTERAGENCY TASK FORCE.—
p.000109: (A) Not later than 6 months after the date of the en- actment of the Preventive Health Amendments of
p.000109: 1992 9, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of
p.000109: Lead Poi- soning (in this paragraph referred to as the ‘‘Task Force’’). The Task Force shall coordinate the
p.000109: efforts of Federal agencies to prevent lead poisoning.
p.000109: (B) The Task Force shall be composed of—
p.000109: (i) the Secretary, who shall serve as the chair of the Task Force;
p.000109: (ii) the Secretary of Housing and Urban Develop- ment;
p.000109: (iii) the Administrator of the Environmental Pro- tection Agency; and
p.000109: (iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials re-
p.000109: spectively.
p.000109: (C) The Task Force shall—
p.000109: (i) review, evaluate, and coordinate current strate- gies and plans formulated by the officials serving as
p.000109: members of the Task Force, including—
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p.000109: (vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and
p.000109: not later than May 1 of each year, sub- mit to the Committee on Labor and Human Resources
p.000109:
p.000109:
p.000109:
p.000109: January 30, 2020
p.000109: 9 Enacted October 27, 1992.
p.000109:
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000109: Sec. 317C PUBLIC HEALTH SERVICE ACT 110
p.000109: of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and
p.000109: Commerce of the House of Representa- tives, a report that summarizes the findings made as a result of such
p.000109: review and that contains the rec- ommendations of the Task Force on the programs and policies with respect to
p.000109: which the Task Force is estab- lished, including related budgetary recommendations; and
p.000109: (vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning
p.000109: prevention activities of the Federal Govern- ment.
p.000109: (b) TECHNOLOGY ASSESSMENT AND EPIDEMIOLOGY.—The Sec- retary, acting through the Director of the Centers for
p.000109: Disease Con- trol and Prevention, shall, directly or through grants or contracts—
p.000109: (1) provide for the development of improved, more cost-ef- fective testing measures for detecting lead toxicity
p.000109: in children;
p.000109: (2) provide for the development of improved methods of as- sessing the prevalence of lead poisoning, including such
p.000109: meth- ods as may be necessary to conduct individual assessments for each State;
p.000109: (3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and
p.000109: children, on the de- mographic characteristics of infants and children with such poisoning (including racial
p.000109: and ethnic status), and on the source of payment for treatment for such poisoning (including the
p.000109: extent to which insurance has paid for such treatment); and
p.000109: (4) provide for any applied research necessary to improve the effectiveness of programs for the
p.000109: prevention of lead poi- soning in infants and children.
p.000109: NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES
p.000109: SEC. 317C. ø247b–4¿ (a) IN GENERAL.—
p.000109: (1) NATIONAL CENTER.—There is established within the Centers for Disease Control and Prevention a center
p.000109: to be known as the National Center on Birth Defects and Develop- mental Disabilities (referred to in this
p.000109: section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease
p.000109: Control and Prevention.
p.000109: (2) GENERAL DUTIES.—The Secretary shall carry out pro- grams—
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p.000109: (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and
p.000109: disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the
p.000109: causes of such de- fects and disabilities and on the incidence and prevalence of such defects and disabilities;
p.000109: (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention
p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111: PUBLIC HEALTH SERVICE ACT
p.000111: Sec. 317C
p.000111:
p.000111: (C) to provide information and education to the public on the prevention of such defects and disabilities;
p.000111: (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary
p.000111: health conditions among individuals with disabilities; and
p.000111: (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common
p.000111: permanently disabling birth defect.
p.000111: (3) FOLIC ACID.—The Secretary shall carry out section 317J through the Center.
p.000111: (4) CERTAIN PROGRAMS.—
p.000111: (A) TRANSFERS.—All programs and functions described in subparagraph (B) are transferred to the Center, effec-
p.000111: tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health
p.000111: Act of 2000 10.
p.000111: (B) RELEVANT PROGRAMS.—The programs and func- tions described in this subparagraph are all programs and functions
p.000111: that—
p.000111: (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn
p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
p.000111: sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the
p.000111: Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act
p.000111: referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of
p.000111: the amounts, or the avail- ability of the amounts with respect to the purposes for which the amounts may
p.000111: be expended.
p.000111: (b) GRANTS AND CONTRACTS.—
p.000111: (1) IN GENERAL.—In carrying out subsection (a), the Sec- retary may make grants to and enter into contracts
p.000111: with public and nonprofit private entities.
p.000111: (2) SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.—
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p.000123: authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each
p.000123: of the fiscal years 1995 through 2002.
p.000123: (2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For pur- poses of carrying out this section with respect to
p.000123: qualified health professionals serving in the Epidemic Intelligence Serv- ice, as authorized under section 317G, there
p.000123: is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.
p.000123: (d) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated for a fiscal year for contracts under subsection
p.000123: (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year
p.000123: for which the amounts were appropriated.
p.000123: SEC. 317G. ø247b–8¿ FELLOWSHIP AND TRAINING PROGRAMS.
p.000123: The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.000123: establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop skills
p.000123: in epidemiology, surveillance, laboratory anal- ysis, and other disease detection and prevention methods. Such
p.000123: programs shall be designed to enable health professionals and health personnel trained under such programs
p.000123: to work, after re- ceiving such training, in local, State, national, and international ef- forts toward the
p.000123: prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be
p.000123: administered through the use of either appointment or nonappointment proce- dures.
p.000123:
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p.000123: January 30, 2020
p.000123: DIABETES IN CHILDREN AND YOUTH
p.000123: SEC. 317H. ø247b–9¿ (a) SURVEILLANCE ON JUVENILE DIABE-
p.000123: TES.—The Secretary, acting through the Director of the Centers for
p.000123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000123:
p.000123: Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including
p.000123: with respect to inci- dence and prevalence, and shall establish a national database for such data.
p.000123: (b) TYPE 2 DIABETES IN YOUTH.—The Secretary shall imple- ment a national public health effort to address
p.000123: type 2 diabetes in youth, including—
p.000123: (1) enhancing surveillance systems and expanding re- search to better assess the prevalence and
p.000123: incidence of type 2 diabetes in youth and determine the extent to which type 2 di- abetes is incorrectly
p.000123: diagnosed as type 1 diabetes among chil- dren; and
p.000123: (2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes
p.000123: including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia
p.000123: and improving existing glucometers that measure blood glucose.
p.000123: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000123: COMPILATION OF DATA ON ASTHMA
p.000123: SEC. 317I. ø247b–10¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for
p.000123: Disease Control and Pre- vention, shall—
p.000123: (1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and
p.000123: the quality of asthma management;
p.000123: (2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
p.000123: (3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma
p.000123: nationally.
p.000123: (b) SURVEILLANCE ACTIVITIES.—The Director of the Centers for Disease Control and Prevention, acting through the
p.000123: representative of the Director on the National Asthma Education Prevention Pro- gram Coordinating Committee, shall, in
p.000123: carrying out subsection (a), provide an update on surveillance activities at each Committee meeting.
p.000123: (c) COLLABORATIVE EFFORTS.—The activities described in sub- section (a)(1) may be conducted in
p.000123: collaboration with eligible enti- ties awarded a grant under section 399L.
p.000123: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000123:
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p.000123: January 30, 2020
p.000123:
p.000123: EFFECTS OF FOLIC ACID IN PREVENTION OF BIRTH DEFECTS
p.000123: SEC. 317J. ø247b–11¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000123: Control and Pre- vention, shall expand and intensify programs (directly or through grants or contracts) for
p.000123: the following purposes:
p.000123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: PUBLIC HEALTH SERVICE ACT
p.000131: Sec. 317L–1
p.000131:
p.000131: (C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
p.000131: (b) GRANTS.—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States,
p.000131: local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and
p.000131: other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties.
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p.000131: January 30, 2020
p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
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p.000133: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention
p.000133: and in collaboration with the Administrator of the Health Resources and Services Administration, shall
p.000133: award a grant to each of the 50 States and territories and to Indians, Indian tribes, trib- al organizations
p.000133: and urban Indian organizations (as such
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000133: terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development
p.000133: of school-based dental sealant programs to improve the access of children to sealants.
p.000133: (2) USE OF FUNDS.—A State shall use amounts received under a grant under paragraph (1) to provide funds to
p.000133: eligible school-based entities or to public elementary or secondary schools to enable such entities
p.000133: or schools to provide children with access to dental care and dental sealant services. Such services
p.000133: shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws.
p.000133: (3) ELIGIBILITY.—To be eligible to receive funds under paragraph (1), an entity shall—
p.000133: (A) prepare and submit to the State an application at such time, in such manner and containing such informa-
p.000133: tion as the State may require; and
p.000133: (B) be a public elementary or secondary school—
p.000133: (i) that is located in an urban area in which and more than 50 percent of the student population is par-
p.000133: ticipating in Federal or State free or reduced meal pro- grams; or
p.000133: (ii) that is located in a rural area and, with re- spect to the school district in which the school
p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
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p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135: January 30, 2020
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p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000135:
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p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
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p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
p.000135: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000135: such Act;
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p.000135: (B) the head start program established under the
p.000135: Head Start Act (42 U.S.C. 9831 et seq.);
p.000135: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000135: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000135: (D) local public and private elementary or secondary schools; or
p.000135: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000135: U.S.C. 1437a).
p.000135: (c) PERFORMANCE MEASURES.—The Secretary shall establish needs indicators and performance measures to evaluate the
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p.000169: (B) a discussion of changes to any evidence-based benchmarks and objective standards, and the effect of
p.000169: such changes on the ability to track whether entities are meet- ing or making progress toward the goals under this
p.000169: section and, to the extent practicable, the applicable goals of the National Health Security Strategy under
p.000169: section 2802;
p.000169: (C) a description of amounts received by eligible enti- ties described in subsection (b) and section 319C–2(b),
p.000169: and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and
p.000169: objec- tive standards; and
p.000169: (D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective
p.000169: standards to more accurately assess the ability of entities receiving awards under this section to better
p.000169: achieve the goals under this section and section 2802.
p.000169: SEC. 319C–2. ø247d–3b¿ PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS TO IMPROVE SURGE CAPAC-
p.000169: ITY.
p.000169: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award
p.000169: competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity
p.000169: and enhance community and hospital preparedness for, and response to, public health emer- gencies in
p.000169: accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of
p.000169: children and other at-risk individuals.
p.000169: (b) ELIGIBILITY.—To be eligible for an award under subsection (a), an entity shall—
p.000169: (1)(A) be a coalition that includes—
p.000169: (i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with
p.000169: section 1213(c);
p.000169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000171: PUBLIC HEALTH SERVICE ACT
p.000171: Sec. 319C–2
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p.000171: (ii) one or more other local health care facilities, in- cluding clinics, health centers, community
p.000171: health centers, primary care facilities, mental health centers, mobile med- ical assets, or nursing homes;
p.000171: (iii)(I) one or more political subdivisions;
p.000171: (II) one or more States; or
p.000171: (III) one or more States and one or more political sub- divisions; and
p.000171: (iv) one or more emergency medical service organiza- tions or emergency management organizations; and
p.000171: (B) prepare, in consultation with the Chief Executive Offi- cer and the lead health officials of the State, District,
p.000171: or terri- tory in which the hospital and health care facilities described in subparagraph (A) are located,
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p.000175: PUBLIC HEALTH SERVICE ACT
p.000175: Sec. 319C–3
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p.000175: and health care workers (including with respect to protec- tive equipment and supplies, waste management
p.000175: proc- esses, and decontamination), sharing of specialized experi- ence among the health care workforce,
p.000175: behavioral health, psychological resilience, and training of the workforce, as applicable;
p.000175: (D) in a manner that allows for disease containment (within the meaning of section 2802(b)(2)(B)),
p.000175: coordinated medical triage, treatment, and transportation of patients, based on patient medical need (including
p.000175: patients in rural areas), to the appropriate hospitals or health care facilities within the regional system or, as
p.000175: applicable and appro- priate, between systems in different States or regions; and
p.000175: (E) the needs of children and other at-risk individuals;
p.000175: (2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner
p.000175: that does not compromise national security; and
p.000175: (3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and
p.000175: infor- mation resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and
p.000175: Advancing Inno- vation Act of 2019 (including any amendments made by such Act), to address new and emerging
p.000175: public health threats.
p.000175: (c) CONSIDERATIONS.—In identifying, developing, and updating guidelines under subsection (b), the Assistant
p.000175: Secretary for Pre- paredness and Response shall—
p.000175: (1) include input from hospitals and health care facilities (including health care coalitions under
p.000175: section 319C–2), State, local, Tribal, and territorial public health departments, and health care or
p.000175: subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or
p.000175: nu- clear threats, including emerging infectious diseases), as the Assistant Secretary determines
p.000175: appropriate, to meet the goals under section 2802(b)(3);
p.000175: (2) consult and engage with appropriate health care pro- viders and professionals, including physicians,
p.000175: nurses, first re- sponders, health care facilities (including hospitals, primary care clinics, community health
p.000175: centers, mental health facilities, ambulatory care facilities, and dental health facilities), phar- macies,
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p.000185: (i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000185: $161,800,000 for each of fiscal years 2019 through 2023.
p.000185: (j) DEFINITION.—For purposes of this section the term ‘‘bio- surveillance’’ means the process of gathering near
p.000185: real-time biologi- cal data that relates to human and zoonotic disease activity and
p.000185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000185: Sec. 319D–1 PUBLIC HEALTH SERVICE ACT 186
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p.000185: threats to human or animal health, in order to achieve early warn- ing and identification of such health threats,
p.000185: early detection and prompt ongoing tracking of health events, and overall situational awareness of disease
p.000185: activity.
p.000185: SEC. 319D–1. ø247d-4b¿ CHILDREN’S PREPAREDNESS UNIT.
p.000185: (a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.— The Secretary, acting through the Director of the
p.000185: Centers for Dis- ease Control and Prevention (referred to in this subsection as the ‘‘Director’’), shall
p.000185: maintain an internal team of experts, to be known as the Children’s Preparedness Unit (referred to in
p.000185: this sub- section as the ‘‘Unit’’), to work collaboratively to provide guidance on the considerations for, and
p.000185: the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the
p.000185: Director regarding emergency preparedness and response ef- forts pertaining to children at the Centers for
p.000185: Disease Control and Prevention.
p.000185: (b) EXPERTISE.—The team described in subsection (a) shall in- clude one or more pediatricians, which may be a
p.000185: developmental-be- havioral pediatrician, and may also include behavioral scientists, child psychologists,
p.000185: epidemiologists, biostatisticians, health commu- nications staff, and individuals with other areas of expertise, as the
p.000185: Secretary determines appropriate.
p.000185: (c) DUTIES.—The team described in subsection (a) may—
p.000185: (1) assist State, local, Tribal, and territorial emergency planning and response activities related to children,
p.000185: which may include developing, identifying, and sharing best practices;
p.000185: (2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public
p.000185: health of- ficials to improve preparedness and response capabilities with respect to the needs of children,
p.000185: including providing such tech- nical assistance, training, and consultation to eligible entities in order to
p.000185: support the achievement of measurable evidence- based benchmarks and objective standards applicable to sec-
p.000185: tions 319C–1 and 319C–2;
p.000185: (3) improve the utilization of methods to incorporate the needs of children in planning for and
p.000185: responding to a public health emergency, including public awareness of such methods;
p.000185: (4) coordinate with, and improve, public-private partner- ships, such as health care coalitions
p.000185: pursuant to sections 319C–2 and 319C–3, to address gaps and inefficiencies in emergency preparedness and
p.000185: response efforts for children;
p.000185: (5) provide expertise and input during the development of guidance and clinical recommendations to address the
p.000185: needs of children when preparing for, and responding to, public health emergencies, including pursuant to
p.000185: section 319C–3; and
p.000185: (6) carry out other duties related to preparedness and re- sponse activities for children, as the
p.000185: Secretary determines ap- propriate.
p.000185: SEC. 319E. ø247d–5¿ COMBATING ANTIMICROBIAL RESISTANCE.
p.000185: (a) TASK FORCE.—
p.000185: (1) IN GENERAL.—The Secretary shall establish an Anti- microbial Resistance Task Force to provide advice
p.000185: and rec- ommendations to the Secretary and coordinate Federal pro-
p.000185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000187: PUBLIC HEALTH SERVICE ACT
p.000187: Sec. 319E
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p.000187: grams relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other
p.000187: organization in exist- ence as of the date of the enactment of this section, to serve as such a task
p.000187: force, if such committee, or other organization meets the requirements of this section.
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p.000191: arranging for students enrolled in the program to obtain continuing professional education credit for program
p.000191: courses.
p.000191: (5) DISSEMINATION AND TRAINING.—
p.000191: (A) IN GENERAL.—The Secretary may provide for the dissemination and teaching of the materials described
p.000191: in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary.
p.000191: (B) CERTAIN ENTITIES.—The education and training ac- tivities described in subparagraph (A) may be carried out
p.000191: by Federal public health, medical, or dental entities, ap- propriate educational entities, professional
p.000191: organizations and societies, private accrediting organizations, and other nonprofit institutions or entities
p.000191: meeting criteria estab- lished by the Secretary.
p.000191: (C) GRANTS AND CONTRACTS.—In carrying out this sub- section, the Secretary may carry out activities directly or
p.000191: through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
p.000191: (b) ADVICE TO THE FEDERAL GOVERNMENT.—
p.000191: (1) REQUIRED ADVISORY COMMITTEES.—In coordination with the working group under subsection (a), the
p.000191: Secretary shall establish advisory committees in accordance with para- graphs (2) and (3) to provide expert
p.000191: recommendations to assist such working groups in carrying out their respective respon- sibilities under
p.000191: subsections (a) and (b) 19.
p.000191: (2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER- RORISM 20.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the National Advisory Committee on At-Risk In- dividuals and Public Health Emergencies (referred
p.000191: to in this paragraph as the ‘‘Advisory Committee’’).
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p.000191: 19 Probably should be ‘‘to assist such working group in carrying out its responsibilities under subsection (a)’’.
p.000191: Formerly there were two working groups, one under subsection (a) and one under subsection (b). Now there is
p.000191: only the working group under subsection (a). See the amend- ments made by sections 104(a) and 108 of Public Law 107–188
p.000191: (116 Stat. 605, 609).
p.000191: 20 The heading for subsection (b)(2) probably should read ‘‘NATIONAL ADVISORY COMMITTEE ON AT-RISK INDIVIDUALS AND
p.000191: PUBLIC HEALTH EMERGENCIES’’. The amendment made by section 301(d)(1) of Public Law 109–417 (120 Stat.
p.000191: 2854) to strike ‘‘CHILDREN AND TERRORISM’’ and in- sert ‘‘AT-RISK INDIVIDUALS AND PUBLIC HEALTH
p.000191: EMERGENCIES’’ could not be executed due to incor- rect capitalization of the word ‘‘Children’’ in the matter to be
p.000191: struck. Also the letter ‘‘A’’ in the word ‘‘At-risk’’ in the inserted text probably should be lowercase type.
p.000191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000191: Sec. 319F PUBLIC HEALTH SERVICE ACT 192
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p.000191: (B) DUTIES.—The Advisory Committee shall provide recommendations regarding—
p.000191: (i) the preparedness of the health care (including mental health care) system to respond to public health
p.000191: emergencies as they relate to at-risk individuals;
p.000191: (ii) needed changes to the health care and emer- gency medical service systems and emergency medical services
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p.000193: (e) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY PATHOGENS AND COUNTERMEASURES.—
p.000193: (1) IN GENERAL.—With respect to pathogens of potential use in a bioterrorist attack, and other agents
p.000193: that may cause a public health emergency, the Secretary, taking into consider- ation any recommendations of the
p.000193: working group under sub- section (a), shall conduct, and award grants, contracts, or coop- erative agreements for,
p.000193: research, investigations, experiments, demonstrations, and studies in the health sciences relating to—
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p.000193: (A) the epidemiology and pathogenesis of such patho- gens;
p.000193: (B) the sequencing of the genomes, or other DNA anal- ysis, or other comparative analysis, of priority pathogens
p.000193: (as determined by the Director of the National Institutes of Health in consultation with the working
p.000193: group estab- lished in subsection (a)), in collaboration and coordination with the activities of the
p.000193: Department of Defense and the Joint Genome Institute of the Department of Energy;
p.000193: (C) the development of priority countermeasures; and
p.000193: (D) other relevant areas of research;
p.000193: with consideration given to the needs of children and other vul- nerable populations.
p.000193: (2) PRIORITY.—The Secretary shall give priority under this section to the funding of research and other studies related
p.000193: to priority countermeasures.
p.000193: (3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In car- rying out paragraph (1), the Secretary shall consider using
p.000193: the biomedical research and development capabilities of the De- partment of Veterans Affairs, in conjunction
p.000193: with that Depart- ment’s affiliations with health-professions universities. When advantageous to the Government
p.000193: in furtherance of the pur- poses of such paragraph, the Secretary may enter into coopera- tive agreements with
p.000193: the Secretary of Veterans Affairs to achieve such purposes.
p.000193: (4) PRIORITY COUNTERMEASURES.—For purposes of this sec- tion, the term ‘‘priority countermeasure’’ means a drug,
p.000193: biologi- cal product, device, vaccine, vaccine adjuvant, antiviral, or di- agnostic test that the Secretary
p.000193: determines to be—
p.000193: (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to
p.000193: section 351A(a)(1), or harm from any other agent that may cause a public health emergency; or
p.000193: (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences
p.000193: or death
p.000193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000243: agreements to, and may enter into other transactions with, highly qualified foreign national persons outside
p.000243: the United States, alone or in collaboration with American participants, when such transactions may inure to
p.000243: the ben- efit of the American people.
p.000243: (F) ESTABLISHMENT OF RESEARCH CENTERS.—The Sec- retary may assess the feasibility and appropriateness of
p.000243: establishing, through contract, grant, cooperative agree- ment, or other transaction, an arrangement with an
p.000243: exist- ing research center in order to achieve the goals of this section. If such an agreement is not
p.000243: feasible and appro- priate, the Secretary may establish one or more federally- funded research and
p.000243: development centers, or university-af- filiated research centers, in accordance with section 303(c)(3) of
p.000243: the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(3)).
p.000243: (G) GOVERNMENT PURPOSE.—In awarding contracts, grants, and cooperative agreements under this section, the
p.000243: Secretary shall provide a clear statement of defined Gov- ernment purpose related to activities
p.000243: included in sub- section (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
p.000243: (6) AT-RISK INDIVIDUALS.—In carrying out the functions under this section, the Secretary may give priority
p.000243: to the ad- vanced research and development of qualified countermeasures and qualified pandemic or epidemic products
p.000243: that are likely to be safe and effective with respect to children, pregnant women,
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000243: Sec. 319L PUBLIC HEALTH SERVICE ACT 244
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p.000243: January 30, 2020
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p.000243: older adults, and other at-risk individuals with relevant char- acteristics that warrant consideration during
p.000243: the process of re- searching and developing such countermeasures and products.
p.000243: (7) PERSONNEL AUTHORITIES.—
p.000243: (A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFES- SIONAL PERSONNEL.—
p.000243: (i) IN GENERAL.—In addition to any other per- sonnel authorities, the Secretary may—
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p.000251: Ex- ecutive Schedule under section 5315 of title 5, United States Code, for each day (including travel
p.000251: time) during which the member is engaged in the actual performance of duties as a member of the Board.
p.000251: (C) TRAVEL EXPENSES.—Each member of the Board shall receive travel expenses, including per diem in lieu of
p.000251: subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5,
p.000251: United States Code.
p.000251: (D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board with the
p.000251: approval for the contributing agency without reim- bursement, and such detail shall be without
p.000251: interruption or loss of civil service status or privilege.
p.000251: (b) OTHER WORKING GROUPS.—The Secretary may establish a working group of experts, or may use an existing working
p.000251: group or advisory committee, to—
p.000251: (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified
p.000251: pandemic or epidemic product;
p.000251: (2) identify accepted animal models for particular diseases and conditions associated with any biological,
p.000251: chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify
p.000251: strategies to accelerate animal model and research tool development and validation; and
p.000251: (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified
p.000251: counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective
p.000251: with respect to children, pregnant women, and other vulnerable populations, and other issues regarding
p.000251: activities under this section that affect such populations.
p.000251: (c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same
p.000251: meaning in this section as such term is given in section 319L.
p.000251: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $1,000,000 to carry out this
p.000251: section for fiscal year 2007 and each fiscal year thereafter.
p.000251: HANSEN’S DISEASE PROGRAM
p.000251: SEC. 320. ø247e¿ (a)(1) At or through the National Hansen’s Disease Programs Center (located in the
p.000251: State of Louisiana), the Secretary shall without charge provide short-term care and treat- ment, including
p.000251: outpatient care, for Hansen’s disease and related complications to any person determined by the Secretary
p.000251: to be in need of such care and treatment. The Secretary may not at or through such Center provide
p.000251: long-term care for any such disease or complication.
p.000251: (2) The Center referred to in paragraph (1) shall conduct train- ing in the diagnosis and management of Hansen’s
p.000251: disease and re- lated complications, and shall conduct and promote the coordina-
p.000251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000253: Act, 1998. 25
p.000253: (b) In addition to the Center referred to in subsection (a), the Secretary may establish sites regarding
p.000253: persons with Hansen’s dis- ease. Each such site shall provide for the outpatient care and treat- ment for Hansen’s
p.000253: disease and related complications to any person determined by the Secretary to be in need of such care and
p.000253: treat- ment.
p.000253: (c) The Secretary shall carry out subsections (a) and (b) acting through an agency of the Service. For purposes
p.000253: of the preceding sentence, the agency designated by the Secretary shall carry out both activities relating
p.000253: to the provision of health services and ac- tivities relating to the conduct of research.
p.000253: (d) The Secretary shall make payments to the Board of Health of the State of Hawaii for the care and treatment
p.000253: (including out- patient care) in its facilities of persons suffering from Hansen’s dis- ease at a rate determined
p.000253: by the Secretary. The rate shall be ap- proximately equal to the operating cost per patient of such
p.000253: facili- ties, except that the rate may not exceed the comparable costs per patient with Hansen’s disease for care
p.000253: and treatment provided by the Center referred to in subsection (a). Payments under this sub- section are subject
p.000253: to the availability of appropriations for such purpose.
p.000253:
p.000253: COORDINATED PROGRAM TO IMPROVE PEDIATRIC ORAL HEALTH
p.000253: SEC. 320A. 26 ø247d–8¿ (a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources
p.000253: and Services Administration, shall establish a program to fund innovative oral health activities that
p.000253: improve the oral health of children under 6 years of age who are eligible for services provided under a Federal
p.000253: health program, to increase the utilization of dental services by such children, and to decrease the incidence
p.000253: of early childhood and baby bottle tooth decay.
p.000253: (b) GRANTS.—The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of
p.000253: dentistry or ac- credited dental training institutions or programs, community den- tal programs, and programs
p.000253: operated by the Indian Health Service (including federally recognized Indian tribes that receive medical
p.000253: services from the Indian Health Service, urban Indian health pro- grams funded under title V of the
p.000253: Indian Health Care Improve- ment Act, and tribes that contract with the Indian Health Service pursuant to
p.000253: the Indian Self-Determination and Education Assist- ance Act) to enable such schools, institutions, and programs
p.000253: to de- velop programs of oral health promotion, to increase training of oral health services providers in
p.000253: accordance with State practice
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p.000253: January 30, 2020
p.000253: 25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489.
p.000253: 26 The placement of this section in title III was carried out to reflect the probable intent of
p.000253: Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to ‘‘Part B of
p.000253: the Public Health Service Act’’, without specifying which title of this Act was the subject of the
p.000253: amendment.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000253: Sec. 321 PUBLIC HEALTH SERVICE ACT 254
p.000253: laws, or to increase the utilization of dental services by eligible children.
p.000253: (c) DISTRIBUTION.—In awarding grants under this section, the Secretary shall, to the extent practicable,
p.000253: ensure an equitable na- tional geographic distribution of the grants, including areas of the United States
p.000253: where the incidence of early childhood caries is high- est.
p.000253: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000253: $10,000,000 for each the fiscal years 2001 through 2005.
p.000253: PART C—HOSPITALS, MEDICAL EXAMINATIONS, AND MEDICAL CARE
p.000253: HOSPITALS
p.000253: SEC. 321. ø248¿ The Surgeon General, pursuant to regulations, shall—
p.000253: (a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and
p.000253: main- tenance, and provide for the care, treatment, and hospitaliza- tion of patients, including the
p.000253: furnishing of prosthetic and or- thopedic devices; and from time to time with the approval of the
p.000253: President, select suitable sites for and establish such addi- tional institutions, hospitals, and stations in the
p.000253: States and possessions of the United States as in his judgment are nec- essary to enable the Service to
p.000253: discharge its functions and du- ties;
p.000253: (b) Provide for the transfer of Public Health Service pa- tients, in the care of attendants where necessary,
p.000253: between hos- pitals and stations operated by the Service or between such hospitals and stations and other
p.000253: hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such
p.000253: transfer;
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p.000263: subsection (b)(1) or additional health services de- scribed in subsection (b)(2).
p.000263: (ii) PRIORITY EXPANSION PROJECTS.—In carrying out clause (i), the Secretary may give special consider- ation to
p.000263: expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health,
p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
p.000263: providing serv- ices to any medically underserved population among which there is a substantial incidence
p.000263: of infant mortality or among which there is a significant increase in the incidence of infant mortality.
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
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p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: January 30, 2020
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p.000265: tablishes for the purposes of such employment a temporary abode.
p.000265: (B) SEASONAL AGRICULTURAL WORKER.—The term ‘‘sea- sonal agricultural worker’’ means an individual whose
p.000265: principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.
p.000265: (C) AGRICULTURE.—The term ‘‘agriculture’’ means farming in all its branches, including—
p.000265: (i) cultivation and tillage of the soil;
p.000265: (ii) the production, cultivation, growing, and har- vesting of any commodity grown on, in, or as an ad-
p.000265: junct to or part of a commodity grown in or on, the land; and
p.000265: (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to
p.000265: carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an
p.000265: activity described in clause (ii).
p.000265: (h) HOMELESS POPULATION.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of homeless
p.000265: individuals, including grants for innovative programs that provide outreach and com- prehensive primary health
p.000265: services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and
p.000265: veterans at risk of homelessness.
p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
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p.000269: the non-urgent use of hospital emergency departments;
p.000269: (C) the center will have an ongoing quality improve- ment system that includes clinical services and
p.000269: manage- ment, and that maintains the confidentiality of patient records;
p.000269: (D) the center will demonstrate its financial responsi- bility by the use of such accounting procedures
p.000269: and other requirements as may be prescribed by the Secretary;
p.000269: (E) the center—
p.000269: (i)(I) has or will have a contractual or other ar- rangement with the agency of the State, in which
p.000269: it provides services, which administers or supervises the administration of a State plan approved under title
p.000269: XIX of the Social Security Act for the payment of all or a part of the center’s costs in providing health
p.000269: serv- ices to persons who are eligible for medical assistance under such a State plan; and
p.000269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000269: Sec. 330 PUBLIC HEALTH SERVICE ACT 270
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p.000269: (II) 32 has or will have a contractual or other arrangement with the State agency administering the program
p.000269: under title XXI of such Act (42
p.000269: U.S.C. 1397aa et seq.) with respect to individuals who are State children’s health insurance program
p.000269: beneficiaries; or
p.000269: (ii) has made or will make every reasonable effort to enter into arrangements described in subclauses (I) and (II) of
p.000269: clause (i);
p.000269: (F) the center has made or will make and will con- tinue to make every reasonable effort to collect
p.000269: appropriate reimbursement for its costs in providing health services to persons who are entitled to insurance
p.000269: benefits under title XVIII of the Social Security Act, to medical assistance under a State plan approved
p.000269: under title XIX of such Act, or to assistance for medical expenses under any other pub- lic assistance program
p.000269: or private health insurance pro- gram;
p.000269: (G) the center—
p.000269: (i) has prepared a schedule of fees or payments for the provision of its services consistent with locally pre- vailing
p.000269: rates or charges and designed to cover its rea- sonable costs of operation and has prepared a cor- responding
p.000269: schedule of discounts to be applied to the payment of such fees or payments, which discounts are
p.000269: adjusted on the basis of the patient’s ability to pay;
p.000269: (ii) has made and will continue to make every rea- sonable effort—
p.000269: (I) to secure from patients payment for serv- ices in accordance with such schedules; and
p.000269: (II) to collect reimbursement for health serv- ices to persons described in subparagraph (F) on the basis
p.000269: of the full amount of fees and payments for such services without application of any dis- count;
p.000269: (iii)(I) will assure that no patient will be denied health care services due to an individual’s inability to
p.000269: pay for such services; and
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p.000283: PUBLIC HEALTH SERVICE ACT
p.000283: Sec. 330E
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p.000283: public or nonprofit private entities for the establishment and oper- ation of regional centers whose purpose is to
p.000283: develop, evaluate, and disseminate effective strategies, which utilize quality management measures, to assist
p.000283: public and private health care programs and providers in the appropriate utilization of preventive health
p.000283: care services by specific populations.
p.000283: (b) RESEARCH AND TRAINING.—The activities carried out by a center under subsection (a) may include
p.000283: establishing programs of research and training with respect to the purpose described in such subsection, including
p.000283: the development of curricula for training indi- viduals in implementing the strategies developed under such
p.000283: sub- section.
p.000283: (c) PRIORITY REGARDING INFANTS AND CHILDREN.—In carrying out the purpose described in subsection (a), the
p.000283: Secretary shall give priority to various populations of infants, young children, and their mothers.
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004.
p.000283: SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
p.000283: (a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
p.000283: (1) IN GENERAL.—The Secretary shall develop and imple- ment public health surveillance, education, research, and
p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
p.000283: targeted to parents, schools, daycare providers, patients;
p.000283: (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig-
p.000283: mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth;
p.000283: (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and
p.000283: related needs of people with disabilities; and
p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000283: (3) COORDINATION OF ACTIVITIES.—The Secretary shall en- sure that activities under this subsection are
p.000283: coordinated as appropriate with other agencies of the Public Health Service that carry out activities
p.000283: regarding epilepsy and seizure.
p.000283: (b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDI-
p.000283: CALLY UNDERSERVED AREAS.—
p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000283: Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access
p.000283: to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others
p.000283: residing in medically underserved areas.
p.000283: (2) APPLICATION FOR GRANT.—A grant may not be awarded under paragraph (1) unless an application therefore is
p.000283: sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted
p.000283: in such form and manner and shall contain such information as the Secretary may prescribe.
p.000283: (c) DEFINITIONS.—For purposes of this section:
p.000283: (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive
p.000283: electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may
p.000283: revise the definition of such term to the extent the Secretary determines necessary.
p.000283: (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6).
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000283: SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
p.000283: (a) INFANT ADOPTION AWARENESS.—
p.000283: (1) IN GENERAL.—The Secretary shall make grants to na- tional, regional, or local adoption organizations for
p.000283: the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers
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p.000283: which the participants are—
p.000283: (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise
p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
p.000285: (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing
p.000285: training for the designated staff of eligible health cen- ters, such organization will make reasonable efforts to
p.000285: ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of
p.000285: the adoption process and are experienced in pro- viding adoption information and referrals in the geo-
p.000285: graphic areas in which the eligible health centers are located, and that the designated staff
p.000285: receive the training in such areas.
p.000285: (B) RULE OF CONSTRUCTION REGARDING TRAINING OF TRAINERS.—With respect to individuals who under a grant under
p.000285: paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subpara-
p.000285: graph as ‘‘trainers’’), subparagraph (A)(iii) may not be con- strued as establishing any limitation regarding the
...

p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000285: adoption informa- tion and referral, upon request, are provided by eligible
p.000285:
p.000285:
p.000285:
p.000285: January 30, 2020
p.000285: 36 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000287: PUBLIC HEALTH SERVICE ACT
p.000287: Sec. 330G
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p.000287: health centers. Within a reasonable time after training under this section is initiated, the Secretary
p.000287: shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000287: adoption information and referral, upon request, are provided by eligible health cen- ters in order to determine
...

p.000287: regarding the adoption of chil- dren with special needs.
p.000287: (2) INPUT ON PLANNING AND DEVELOPMENT.—In providing for the planning and development of the national
p.000287: campaign under paragraph (1), the Secretary shall provide for input from a number and variety of adoption organizations
p.000287: throughout the States in order that the full national diversity of interests among adoption organizations
p.000287: is represented in the planning and development of the campaign.
p.000287: (3) CERTAIN FEATURES.—With respect to the national cam- paign under paragraph (1):
p.000287: (A) The campaign shall be directed at various popu- lations, taking into account as appropriate
p.000287: differences among geographic regions, and shall be carried out in the language and cultural context that
p.000287: is most appropriate to the population involved.
p.000287: (B) The means through which the campaign may be carried out include—
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000287: Sec. 330G PUBLIC HEALTH SERVICE ACT 288
p.000287:
p.000287: (i) placing public service announcements on tele- vision, radio, and billboards; and
p.000287: (ii) providing information through means that the Secretary determines will reach individuals who are most likely
p.000287: to adopt children with special needs.
p.000287: (C) The campaign shall provide information on the subsidies and supports that are available to individuals re-
p.000287: garding the adoption of children with special needs.
p.000287: (D) The Secretary may provide that the placement of public service announcements, and the dissemination
p.000287: of brochures and other materials, is subject to review by the Secretary.
p.000287: (4) MATCHING REQUIREMENT.—
p.000287: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out by an entity pursuant
p.000287: to para- graph (1), a condition for the receipt of a grant under such paragraph is that the entity agree to
p.000287: make available (di- rectly or through donations from public or private entities) non-Federal contributions toward
p.000287: such costs in an amount that is not less than 25 percent of such costs.
p.000287: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions under subparagraph (A) may be in cash
p.000287: or in kind, fairly evaluated, including plant, equip- ment, or services. Amounts provided by the Federal
p.000287: Gov- ernment, or services assisted or subsidized to any signifi- cant extent by the Federal Government,
p.000287: may not be in- cluded in determining the amount of such contributions.
p.000287: (b) NATIONAL RESOURCES PROGRAM.—The Secretary shall (di- rectly or through grant or contract) carry out
p.000287: a program that, through toll-free telecommunications, makes available to the public information regarding the
p.000287: adoption of children with special needs. Such information shall include the following:
p.000287: (1) A list of national, State, and regional organizations that provide services regarding such adoptions,
p.000287: including ex- changes and other information on communicating with the or- ganizations. The list shall
p.000287: represent the full national diversity of adoption organizations.
p.000287: (2) Information beneficial to individuals who adopt such children, including lists of support groups for
p.000287: adoptive parents and other postadoptive services.
p.000287: (c) OTHER PROGRAMS.—With respect to the adoption of children with special needs, the Secretary shall make grants—
p.000287: (1) to provide assistance to support groups for adoptive parents, adopted children, and siblings of
p.000287: adopted children; and
p.000287: (2) to carry out studies to identify—
p.000287: (A) the barriers to completion of the adoption process;
p.000287: and
p.000287: (B) those components that lead to favorable long-term
p.000287:
p.000287:
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p.000287: January 30, 2020
p.000287: outcomes for families that adopt children with special needs.
p.000287: (d) APPLICATION FOR GRANT.—The Secretary may make an award of a grant or contract under this section
p.000287: only if an applica- tion for the award is submitted to the Secretary and the applica-
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: PUBLIC HEALTH SERVICE ACT
p.000289: Sec. 330H
p.000289:
p.000289: tion is in such form, is made in such manner, and contains such agreements, assurances, and information
p.000289: as the Secretary deter- mines to be necessary to carry out this section.
p.000289: (e) FUNDING.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as
p.000289: may be nec- essary for each of the fiscal years 2001 through 2005.
p.000289: SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
p.000289: (a) IN GENERAL.—
p.000289: (1) CONTINUATION AND EXPANSION OF PROGRAM.—The Sec- retary, acting through the Administrator of the Health
p.000289: Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of
p.000289: this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent
p.000289: years, carry out such program on a national basis.
...

p.000297: urban commuting area code as set forth by the Office of Manage- ment and Budget).
p.000297: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section to an entity unless the entity agrees
p.000297: that the entity will make available (directly or through contributions from other public or private entities)
p.000297: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of
p.000297: the amount received under the grant.
p.000297: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000297: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section such sums as may be
p.000297: necessary for each of fiscal years 2019 through 2023.
p.000297: (2) ADMINISTRATIVE COSTS.—The Secretary may use not more than 10 percent of the amount appropriated under para-
p.000297: graph (1) for a fiscal year for the administrative expenses of carrying out this section.
p.000297: SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
p.000297: (a) DEFINITIONS.—In this section:
p.000297: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider
p.000297: network that of- fers services that include mental health services provided by qualified mental health
p.000297: providers.
p.000297: (2) QUALIFIED MENTAL HEALTH PROFESSIONALS.—The term ‘‘qualified mental health professionals’’ refers to
p.000297: providers of mental health services reimbursed under the medicare pro- gram carried out under title XVIII
p.000297: of the Social Security Act (42 U.S.C. 1395 et seq.) who have additional training in the treatment of
p.000297: mental illness in children and adolescents or who have additional training in the treatment of mental illness
p.000297: in the elderly.
p.000297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000299: PUBLIC HEALTH SERVICE ACT
p.000299: Sec. 330K
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p.000299: (3) SPECIAL POPULATIONS.—The term ‘‘special populations’’ refers to the following 2 distinct groups:
p.000299: (A) Children and adolescents in mental health under- served rural areas or in mental health underserved urban
p.000299: areas.
p.000299: (B) Elderly individuals located in long-term care facili- ties in mental health underserved rural or urban areas.
p.000299: (4) TELEHEALTH.—The term ‘‘telehealth’’ means the use of electronic information and telecommunications
p.000299: technologies to support long distance clinical health care, patient and profes- sional health-related
p.000299: education, public health, and health ad- ministration.
p.000299: (b) PROGRAM AUTHORIZED.—
p.000299: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Office for the Advancement of Telehealth
p.000299: of the Health Resources and Services Administration, shall award grants to eligible entities to establish
p.000299: demonstration projects for the provision of mental health services to special popu- lations as delivered
p.000299: remotely by qualified mental health profes- sionals using telehealth and for the provision of education re-
p.000299: garding mental illness as delivered remotely by qualified men- tal health professionals using telehealth.
p.000299: (2) POPULATIONS SERVED.—The Secretary shall award the grants under paragraph (1) in a manner that
p.000299: distributes the grants so as to serve equitably the populations described in subparagraphs (A) and (B) of
p.000299: subsection (a)(3).
p.000299: (c) USE OF FUNDS.—
p.000299: (1) IN GENERAL.—An eligible entity that receives a grant under this section shall use the grant funds—
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p.000301: pro- viders’ preferred mechanisms for receiving consultation, training, and technical assistance;
p.000301: (D) develop an online database and communication mechanisms, including telehealth, to facilitate consultation
p.000301: support to pediatric practices;
p.000301: (E) provide rapid statewide or regional clinical tele- phone or telehealth consultations when requested between
p.000301: the pediatric mental health teams and pediatric primary care providers;
p.000301: (F) conduct training and provide technical assistance to pediatric primary care providers to support the
p.000301: early identification, diagnosis, treatment, and referral of chil- dren with behavioral health conditions;
p.000301: (G) provide information to pediatric providers about, and assist pediatric providers in accessing,
p.000301: pediatric men- tal health care providers, including child and adolescent psychiatrists, and licensed
p.000301: mental health professionals, such as psychologists, social workers, or mental health counselors and in
p.000301: scheduling and conducting technical as- sistance;
p.000301: (H) assist with referrals to specialty care and commu- nity or behavioral health resources; and
p.000301: (I) establish mechanisms for measuring and moni- toring increased access to pediatric mental health
p.000301: care services by pediatric primary care providers and expanded capacity of pediatric primary care providers to
p.000301: identify, treat, and refer children with mental health problems.
p.000301: (2) PEDIATRIC MENTAL HEALTH TEAMS.—In this subsection, the term ‘‘pediatric mental health team’’ means a
p.000301: team con- sisting of at least one case coordinator, at least one child and adolescent psychiatrist, and at
p.000301: least one licensed clinical men- tal health professional, such as a psychologist, social worker, or mental
p.000301: health counselor. Such a team may be regionally based.
p.000301: (c) APPLICATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization seeking a
p.000301: grant under this section shall submit an application to the Secretary at such time, in such manner, and
p.000301: containing such information as the Secretary may re- quire, including a plan for the comprehensive evaluation
p.000301: of activi- ties that are carried out with funds received under such grant.
p.000301: (d) EVALUATION.—A State, political subdivision of a State, In- dian tribe, or tribal organization that
p.000301: receives a grant under this section shall prepare and submit an evaluation of activities that are carried
p.000301: out with funds received under such grant to the Sec- retary at such time, in such manner, and containing such
p.000301: informa-
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p.000315: (1) DETERMINATION OF AVAILABLE CORPS MEMBERS.—By April 1 of each calendar year, the Secretary shall
p.000315: determine the number of participants in the Scholarship Program who will be available for assignments under
p.000315: section 333 during the program year beginning on July 1 of that calendar year.
p.000315: (2) DETERMINATION OF NUMBER OF ENTITIES.—At all times during a program year, the number of entities specified under
p.000315: subsection (c)(2)(B)(i) shall be—
p.000315: (A) not less than the number of participants deter- mined with respect to that program year under paragraph
p.000315: (1); and
p.000315: (B) not greater than twice the number of participants determined with respect to that program year under para-
p.000315: graph (1).
p.000315: SEC. 334. ø254g¿ CHARGES FOR SERVICES BY ENTITIES USING CORPS MEMBERS.
p.000315: (a) AVAILABILITY OF SERVICES REGARDLESS OF ABILITY TO PAY OR PAYMENT SOURCE.—An entity to which a Corps
p.000315: member is as- signed shall not deny requested health care services, and shall not discriminate in the provision of
p.000315: services to an individual—
p.000315: (1) because the individual is unable to pay for the services;
p.000315: or
p.000315: (2) because payment for the services would be made
p.000315: under—
p.000315: (A) the medicare program under title XVIII of the So-
p.000315:
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p.000315: cial Security Act (42 U.S.C. 1395 et seq.);
p.000315: (B) the medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.); or
p.000315: (C) the State children’s health insurance program under title XXI of such Act (42 U.S.C. 1397aa et seq.).
p.000315: (b) CHARGES FOR SERVICES.—The following rules shall apply to charges for health care services provided by an
p.000315: entity to which a Corps member is assigned:
p.000315: (1) IN GENERAL.—
p.000315: (A) SCHEDULE OF FEES OR PAYMENTS.—Except as pro- vided in paragraph (2), the entity shall prepare a schedule of
p.000315: fees or payments for the entity’s services, consistent with locally prevailing rates or charges and
p.000315: designed to cover the entity’s reasonable cost of operation.
p.000315: (B) SCHEDULE OF DISCOUNTS.—Except as provided in paragraph (2), the entity shall prepare a corresponding
p.000315: schedule of discounts (including, in appropriate cases, waivers) to be applied to the payment of such fees
p.000315: or pay- ments. In preparing the schedule, the entity shall adjust the discounts on the basis of a patient’s
p.000315: ability to pay.
p.000315: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000315: (C) USE OF SCHEDULES.—The entity shall make every reasonable effort to secure from patients fees and
p.000315: pay- ments for services in accordance with such schedules, and fees or payments shall be sufficiently discounted in
p.000315: accord- ance with the schedule described in subparagraph (B).
p.000315: (2) SERVICES TO BENEFICIARIES OF FEDERAL AND FEDER- ALLY ASSISTED PROGRAMS.—In the case of health
p.000315: care services furnished to an individual who is a beneficiary of a program listed in subsection (a)(2), the
p.000315: entity—
p.000315: (A) shall accept an assignment pursuant to section 1842(b)(3)(B)(ii) of the Social Security Act (42
p.000315: U.S.C. 1395u(b)(3)(B)(ii)) with respect to an individual who is a beneficiary under the medicare program; and
p.000315: (B) shall enter into an appropriate agreement with—
p.000315: (i) the State agency administering the program under title XIX of such Act with respect to an indi-
p.000315: vidual who is a beneficiary under the medicaid pro- gram; and
p.000315: (ii) the State agency administering the program under title XXI of such Act with respect to an indi-
p.000315: vidual who is a beneficiary under the State children’s health insurance program.
p.000315: (3) COLLECTION OF PAYMENTS.—The entity shall take rea- sonable and appropriate steps to collect all
p.000315: payments due for health care services provided by the entity, including payments from any third party (including
p.000315: a Federal, State, or local gov- ernment agency and any other third party) that is responsible for part or all of
p.000315: the charge for such services.
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p.000315: January 30, 2020
p.000315: PROVISION OF HEALTH SERVICES BY CORPS MEMBERS
p.000315: SEC. 335. ø254h¿ (a) In providing health services in a health professional shortage area, Corps members
p.000315: shall utilize the tech- niques, facilities, and organizational forms most appropriate for the area, population
p.000315: group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1)
p.000315: to all individuals in, or served by, such health professional shortage area regardless of their ability
p.000315: to pay for the services, and (2) in a manner which is cooperative with other health care providers
p.000315: serving such health professional shortage area.
p.000315: (b)(1) Notwithstanding any other provision of law, the Sec- retary may (A) to the maximum extent feasible make
p.000315: such arrange- ments as he determines necessary to enable Corps members to uti- lize the health facilities in or serving
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p.000357: January 30, 2020
p.000357: cancer or other chronic diseases to receive better access to high-quality health care services (such as by
p.000357: creating partner- ships with patient advocacy groups, charities, health care cen- ters, community hospice centers,
p.000357: other health care providers, or other organizations in the targeted community).
p.000357: (3) Notifying individuals of clinical trials and, on request, facilitating enrollment of eligible individuals
p.000357: in these trials.
p.000357: (4) Anticipating, identifying, and helping patients to over- come barriers within the health care system to
p.000357: ensure prompt diagnostic and treatment resolution of an abnormal finding of cancer or other chronic disease.
p.000357: (5) Coordinating with the relevant health insurance om- budsman programs to provide information to
p.000357: individuals who are at risk for or who have cancer or other chronic diseases about health coverage,
p.000357: including private insurance, health care savings accounts, and other publicly funded programs (such as Medicare,
p.000357: Medicaid, health programs operated by the Depart- ment of Veterans Affairs or the Department of Defense,
p.000357: the State children’s health insurance program, and any private or governmental prescription assistance
p.000357: programs).
p.000357: (6) Conducting ongoing outreach to health disparity popu- lations, including the uninsured, rural
p.000357: populations, and other medically underserved populations, in addition to assisting other individuals who are
p.000357: at risk for or who have cancer or other chronic diseases to seek preventative care.
p.000357: (c) PROHIBITIONS.—
p.000357: (1) REFERRAL FEES.—The Secretary shall require each re- cipient of a grant under this section to
p.000357: prohibit any patient navigator providing services under the grant from accepting any referral fee, kickback,
p.000357: or other thing of value in return for referring an individual to a particular health care provider.
p.000357: (2) LEGAL FEES AND COSTS.—The Secretary shall prohibit the use of any grant funds received under this
p.000357: section to pay any fees or costs resulting from any litigation, arbitration, me- diation, or other proceeding to
p.000357: resolve a legal dispute.
p.000357: (d) GRANT PERIOD.—
p.000357: (1) IN GENERAL.—Subject to paragraphs (2) and (3), the Secretary may award grants under this section for
p.000357: periods of not more than 3 years.
p.000357: (2) EXTENSIONS.—Subject to paragraph (3), the Secretary may extend the period of a grant under this section. Each
p.000357: such extension shall be for a period of not more than 1 year.
p.000357: (3) LIMITATIONS ON GRANT PERIOD.—In carrying out this section, the Secretary shall ensure that the
p.000357: total period of a grant does not exceed 4 years.
p.000357: (e) APPLICATION.—
p.000357: (1) IN GENERAL.—To seek a grant under this section, an el- igible entity shall submit an application to the
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p.000361: but only if the entity is certified by the Secretary pursuant to paragraph (7).
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p.000361: January 30, 2020
p.000361: (L) A subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act) that—
p.000361: (i) is owned or operated by a unit of State or local government, is a public or private non-profit corpora- tion
p.000361: which is formally granted governmental powers by a unit of State or local government, or is a private non-profit
p.000361: hospital which has a contract with a State or local government to provide health care services to low
p.000361: income individuals who are not entitled to benefits under title XVIII of the Social Security Act or eligible for
p.000361: assistance under the State plan under this title;
p.000361: (ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a dis-
p.000361: proportionate share adjustment percentage (as deter- mined under section 1886(d)(5)(F) of the Social Secu-
p.000361: rity Act) greater than 11.75 percent or was described in section 1886(d)(5)(F)(i)(II) of such Act; and
p.000361: (iii) does not obtain covered outpatient drugs through a group purchasing organization or other
p.000361: group purchasing arrangement.
p.000361: (M) A children’s hospital excluded from the Medicare prospective payment system pursuant to
p.000361: section 1886(d)(1)(B)(iii) of the Social Security Act, or a free-stand- ing cancer hospital excluded from the Medicare
p.000361: prospective payment system pursuant to section 1886(d)(1)(B)(v) of the Social Security Act, that would meet the
p.000361: requirements of subparagraph (L), including the disproportionate share ad- justment percentage requirement under
p.000361: clause (ii) of such subparagraph, if the hospital were a subsection (d) hos- pital as defined by section
p.000361: 1886(d)(1)(B) of the Social Secu- rity Act.
p.000361: (N) An entity that is a critical access hospital (as de- termined under section 1820(c)(2) of the
p.000361: Social Security Act), and that meets the requirements of subparagraph (L)(i).
p.000361: (O) An entity that is a rural referral center, as defined by section 1886(d)(5)(C)(i) of the Social Security
p.000361: Act, or a sole community hospital, as defined by section 1886(d)(5)(C)(iii) of such Act,
p.000361: and that both meets the re- quirements of subparagraph (L)(i) and has a dispropor- tionate share
p.000361: adjustment percentage equal to or greater than 8 percent.
p.000361: (5) REQUIREMENTS FOR COVERED ENTITIES.—
p.000361: (A) PROHIBITING DUPLICATE DISCOUNTS OR REBATES.—
p.000361: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000367: goals of fairness and economy of resources; and
p.000367: (vi) include provisions and procedures to permit multiple covered entities to jointly assert claims of
p.000367: overcharges by the same manufacturer for the same drug or drugs in one administrative proceeding, and
p.000367: permit such claims to be asserted on behalf of covered entities by associations or organizations representing
p.000367: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000367: Sec. 340C PUBLIC HEALTH SERVICE ACT 368
p.000367:
p.000367: the interests of such covered entities and of which the covered entities are members.
p.000367: (C) FINALITY OF ADMINISTRATIVE RESOLUTION.—The administrative resolution of a claim or claims under
p.000367: the regulations promulgated under subparagraph (A) shall be a final agency decision and shall be binding upon the
p.000367: par- ties involved, unless invalidated by an order of a court of competent jurisdiction.
p.000367: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000367: sums as may be necessary for fiscal year 2010 and each succeeding fiscal year.
p.000367: (e) 51 EXCLUSION OF ORPHAN DRUGS FOR CERTAIN COVERED EN- TITIES.—For covered entities described in
p.000367: subparagraph (M) (other than a children’s hospital described in subparagraph (M)), (N), or
p.000367: (O) of subsection (a)(4), the term ‘‘covered outpatient drug’’ shall not include a drug designated by
p.000367: the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or
p.000367: condition.
p.000367: Subpart VIII—Bulk Purchases of Vaccines for Certain Programs
p.000367: BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS
p.000367: SEC. 340C. ø256c¿ (a) AGREEMENTS FOR PURCHASES.—
p.000367: (1) IN GENERAL.—Not later than 180 days after the date of the enactment of the Preventive Health Amendments
p.000367: of 1992 52, the Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention and
p.000367: in consultation with the Administrator of the Health Resources and Services Administration, shall enter into
p.000367: negotiations with manufactur- ers of vaccines for the purpose of establishing and maintaining agreements under which
p.000367: entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in
p.000367: the agreements.
p.000367: (2) RELEVANT ENTITIES.—The entities referred to in para- graph (1) are entities that provide immunizations
p.000367: against vac- cine-preventable diseases with assistance provided under sec- tion 330.
p.000367: (b) NEGOTIATION OF PRICES.—In carrying out subsection (a), the Secretary shall, to the extent practicable,
p.000367: ensure that the prices provided for in agreements under such subsection are comparable to the prices
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p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
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p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.000369: January 30, 2020
p.000369:
p.000369: Subpart IX—Support of Graduate Medical Education Programs in Children’s Hospitals
p.000369: SEC. 340E. ø256e¿ PROGRAM OF PAYMENTS TO CHILDREN’S HOS- PITALS THAT OPERATE GRADUATE MEDICAL EDUCATION
p.000369: PROGRAMS.
p.000369: (a) PAYMENTS.—The Secretary shall make two payments under this section to each children’s hospital for each of fiscal
p.000369: years 2000 through 2005, each of fiscal years 2007 through 2011, each of fiscal years 2014 through 2018, and each
p.000369: of fiscal years 2019 through 2023, one for the direct expenses and the other for indirect ex- penses
p.000369: associated with operating approved graduate medical resi- dency training programs. The Secretary shall
p.000369: promulgate regula- tions pursuant to the rulemaking requirements of title 5, United States Code, which
p.000369: shall govern payments made under this sub- part.
p.000369: (b) AMOUNT OF PAYMENTS.—
p.000369: (1) IN GENERAL.—Subject to paragraphs (2) and (3), the amounts payable under this section to a children’s
p.000369: hospital for an approved graduate medical residency training program for a fiscal year are each of the following
p.000369: amounts:
p.000369: (A) DIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (c) for direct expenses associated
p.000369: with operating approved graduate medical residency train- ing programs.
p.000369: (B) INDIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (d) for indirect expenses associ-
p.000369: ated with the treatment of more severely ill patients and the additional costs relating to teaching
p.000369: residents in such programs.
p.000369: (2) CAPPED AMOUNT.—
p.000369: (A) IN GENERAL.—The total of the payments made to children’s hospitals under paragraph (1)(A) or
p.000369: paragraph (1)(B) in a fiscal year shall not exceed the funds appro- priated under paragraph (1) or (2),
p.000369: respectively, of sub- section (f) for such payments for that fiscal year.
p.000369: (B) PRO RATA REDUCTIONS OF PAYMENTS FOR DIRECT EXPENSES.—If the Secretary determines that the amount of
p.000369: funds appropriated under subsection (f)(1) for a fiscal year is insufficient to provide the total amount of payments
p.000369: oth- erwise due for such periods under paragraph (1)(A), the Secretary shall reduce the amounts so
p.000369: payable on a pro rata basis to reflect such shortfall.
p.000369: (3) ANNUAL REPORTING REQUIRED.—
p.000369: (A) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
p.000369: (i) IN GENERAL.—The amount payable under this section to a children’s hospital for a fiscal year (begin- ning
p.000369: with fiscal year 2008 and after taking into ac- count paragraph (2)) shall be reduced by 25 percent if the
p.000369: Secretary determines that—
p.000369: (I) the hospital has failed to provide the Sec- retary, as an addendum to the hospital’s applica- tion
p.000369: under this section for such fiscal year, the re- port required under subparagraph (B) for the pre- vious fiscal year;
p.000369: or
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000371: 371
p.000371: PUBLIC HEALTH SERVICE ACT
p.000371: Sec. 340E
p.000371:
p.000371: (II) such report fails to provide the informa- tion required under any clause of such subpara- graph.
p.000371: (ii) NOTICE AND OPPORTUNITY TO PROVIDE MISSING INFORMATION.—Before imposing a reduction under clause (i)
p.000371: on the basis of a hospital’s failure to provide information described in clause (i)(II), the Secretary shall
p.000371: provide notice to the hospital of such failure and the Secretary’s intention to impose such reduction and shall provide
p.000371: the hospital with the opportunity to pro- vide the required information within a period of 30 days beginning
p.000371: on the date of such notice. If the hos- pital provides such information within such period, no reduction shall
p.000371: be made under clause (i) on the basis of the previous failure to provide such information.
p.000371: (B) ANNUAL REPORT.—The report required under this subparagraph for a children’s hospital for a fiscal
p.000371: year is a report that includes (in a form and manner specified by the Secretary) the following information for
p.000371: the residency academic year completed immediately prior to such fiscal year:
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p.000371: January 30, 2020
p.000371: (i) The types of resident training programs that the hospital provided for residents described in sub-
p.000371: paragraph (C), such as general pediatrics, internal medicine/pediatrics, and pediatric subspecialties, in-
p.000371: cluding both medical subspecialties certified by the American Board of Pediatrics (such as pediatric gas-
p.000371: troenterology) and non-medical subspecialties ap- proved by other medical certification boards (such
p.000371: as pediatric surgery).
p.000371: (ii) The number of training positions for residents described in subparagraph (C), the number of such po- sitions
p.000371: recruited to fill, and the number of such posi- tions filled.
p.000371: (iii) The types of training that the hospital pro- vided for residents described in subparagraph (C) re-
p.000371: lated to the health care needs of different populations, such as children who are underserved for reasons of
p.000371: family income or geographic location, including rural and urban areas.
p.000371: (iv) The changes in residency training for resi- dents described in subparagraph (C) which the hos- pital
p.000371: has made during such residency academic year (except that the first report submitted by the hospital under this
p.000371: subparagraph shall be for such changes since the first year in which the hospital received pay- ment under this
p.000371: section), including—
p.000371: (I) changes in curricula, training experiences, and types of training programs, and benefits that have
p.000371: resulted from such changes; and
p.000371: (II) changes for purposes of training the resi- dents in the measurement and improvement of the quality
p.000371: and safety of patient care.
p.000371: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000371: Sec. 340E PUBLIC HEALTH SERVICE ACT 372
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p.000371: (v) The numbers of residents described in sub- paragraph (C) who completed their residency training at
p.000371: the end of such residency academic year and care for children within the borders of the service area
p.000371: of the hospital or within the borders of the State in which the hospital is located. Such numbers shall
p.000371: be disaggregated with respect to residents who completed residencies in general pediatrics or internal medicine/
p.000371: pediatrics, subspecialty residencies, and dental residencies.
p.000371: (C) RESIDENTS.—The residents described in this sub- paragraph are those who—
p.000371: (i) are in full-time equivalent resident training po- sitions in any training program sponsored by the hos- pital; or
p.000371: (ii) are in a training program sponsored by an en- tity other than the hospital, but who spend more than 75 percent of
p.000371: their training time at the hospital.
p.000371: (D) REPORT TO CONGRESS.—Not later than the end of fiscal year 2018, and the end of fiscal year 2022,
p.000371: the Sec- retary, acting through the Administrator of the Health Re- sources and Services Administration, shall submit
p.000371: a report to the Congress—
p.000371: (i) summarizing the information submitted in re- ports to the Secretary under subparagraph (B);
p.000371: (ii) describing the results of the program carried out under this section; and
p.000371: (iii) making recommendations for improvements to the program.
p.000371: (c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDU-
p.000371: CATION.—
p.000371: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for direct
p.000371: graduate expenses relating to approved graduate medical residency training programs for a fiscal year is
p.000371: equal to the product of—
p.000371: (A) the updated per resident amount for direct grad- uate medical education, as determined under
p.000371: paragraph (2); and
p.000371: (B) the average number of full-time equivalent resi- dents in the hospital’s graduate approved medical
p.000371: resi- dency training programs (as determined under section 1886(h)(4) of the Social Security Act during the
p.000371: fiscal year.
p.000371: (2) UPDATED PER RESIDENT AMOUNT FOR DIRECT GRADUATE MEDICAL EDUCATION.—The updated per resident amount for di-
p.000371: rect graduate medical education for a hospital for a fiscal year is an amount determined as follows:
p.000371: (A) DETERMINATION OF HOSPITAL SINGLE PER RESIDENT AMOUNT.—The Secretary shall compute for each hospital
p.000371: operating an approved graduate medical education pro- gram (regardless of whether or not it is a
p.000371: children’s hos- pital) a single per resident amount equal to the average (weighted by number of full-time
p.000371: equivalent residents) of the primary care per resident amount and the non-primary care per resident amount
p.000371: computed under section
p.000371: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000373: 373
p.000373: PUBLIC HEALTH SERVICE ACT
p.000373: Sec. 340E
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p.000373: January 30, 2020
p.000373: 1886(h)(2) of the Social Security Act for cost reporting peri- ods ending during fiscal year 1997.
p.000373: (B) DETERMINATION OF WAGE AND NON-WAGE-RELATED PROPORTION OF THE SINGLE PER RESIDENT AMOUNT.—The
p.000373: Secretary shall estimate the average proportion of the sin- gle per resident amounts computed under subparagraph
p.000373: (A) that is attributable to wages and wage-related costs.
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p.000373: non-wage-related portion by applying the proportion determined under subparagraph (B);
p.000373: (ii) by dividing the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social
p.000373: Security Act for discharges occurring during fiscal year 1999 for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (D) DETERMINATION OF NATIONAL AVERAGE.—The Sec- retary shall compute a national average per resident
p.000373: amount equal to the average of the standardized per resi- dent amounts computed under subparagraph (C) for such
p.000373: hospitals, with the amount for each hospital weighted by the average number of full-time equivalent
p.000373: residents at such hospital.
p.000373: (E) APPLICATION TO INDIVIDUAL HOSPITALS.—The Sec- retary shall compute for each such hospital that is a
p.000373: chil- dren’s hospital a per resident amount—
p.000373: (i) by dividing the national average per resident amount computed under subparagraph (D) into a
p.000373: wage-related portion and a non-wage-related portion by applying the proportion determined under subpara- graph
p.000373: (B);
p.000373: (ii) by multiplying the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social Security
p.000373: Act for discharges occurring during the pre- ceding fiscal year for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (F) UPDATING RATE.—The Secretary shall update such per resident amount for each such children’s hospital by the
p.000373: estimated percentage increase in the consumer price index for all urban consumers during the period beginning
p.000373: October 1997 and ending with the midpoint of the Federal fiscal year for which payments are made.
p.000373: (d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
p.000373: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for
p.000373: indirect ex- penses associated with the treatment of more severely ill pa- tients and the additional
p.000373: costs associated with the teaching of residents for a fiscal year is equal to an amount determined
p.000373: appropriate by the Secretary.
p.000373: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000373: Sec. 340E PUBLIC HEALTH SERVICE ACT 374
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p.000373: January 30, 2020
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p.000373: (2) FACTORS.—In determining the amount under para- graph (1), the Secretary shall—
p.000373: (A) take into account variations in case mix among children’s hospitals and the ratio of the number of
p.000373: full- time equivalent residents in the hospitals’ approved grad- uate medical residency training programs to
p.000373: beds (but ex- cluding beds or bassinets assigned to healthy newborn in- fants); and
p.000373: (B) assure that the aggregate of the payments for indi- rect expenses associated with the treatment of more se-
p.000373: verely ill patients and the additional costs related to the teaching of residents under this section in a
p.000373: fiscal year are equal to the amount appropriated for such expenses for the fiscal year involved under subsection
p.000373: (f)(2).
p.000373: (e) MAKING OF PAYMENTS.—
p.000373: (1) INTERIM PAYMENTS.—The Secretary shall determine, before the beginning of each fiscal year involved for which
p.000373: pay- ments may be made for a hospital under this section, the amounts of the payments for direct graduate
p.000373: medical education and indirect medical education for such fiscal year and shall (subject to paragraph (2))
p.000373: make the payments of such amounts in 12 equal interim installments during such period. Such in- terim
p.000373: payments to each individual hospital shall be based on the number of residents reported in the
p.000373: hospital’s most re- cently filed Medicare cost report prior to the application date for the Federal
p.000373: fiscal year for which the interim payment amounts are established. In the case of a hospital that does not report
p.000373: residents on a Medicare cost report, such interim pay- ments shall be based on the number of residents
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p.000375: (i) for fiscal year 2000, $90,000,000;
p.000375: (ii) for fiscal year 2001, $95,000,000;
p.000375: (iii) for each of the fiscal years 2002 through 2005, such sums as may be necessary;
p.000375: (iv) for each of fiscal years 2007 through 2011,
p.000375: $110,000,000;
p.000375: (v) for each of fiscal years 2014 through 2018,
p.000375: $100,000,000; and
p.000375: (vi) for each of fiscal years 2019 through 2023,
p.000375: $105,000,000.
p.000375: (B) CARRYOVER OF EXCESS.—The amounts appro- priated under subparagraph (A) for fiscal year 2000 shall
p.000375: remain available for obligation through the end of fiscal year 2001.
p.000375: (2) INDIRECT MEDICAL EDUCATION.—There are hereby au- thorized to be appropriated, out of any money in the
p.000375: Treasury not otherwise appropriated, for payments under subsection (b)(1)(B)—
p.000375: (A) for fiscal year 2000, $190,000,000; (B) for fiscal year 2001, $190,000,000;
p.000375: (C) for each of the fiscal years 2002 through 2005, such sums as may be necessary;
p.000375: (D) for each of fiscal years 2007 through 2011,
p.000375: $220,000,000;
p.000375: (E) for each of fiscal years 2014 through 2018,
p.000375: $200,000,000; and
p.000375: (F) for each of fiscal years 2019 through 2023,
p.000375: $220,000,000.
p.000375: (g) DEFINITIONS.—In this section:
p.000375: (1) APPROVED GRADUATE MEDICAL RESIDENCY TRAINING PROGRAM.—The term ‘‘approved graduate medical
p.000375: residency training program’’ has the meaning given the term ‘‘approved medical residency training program’’ in
p.000375: section 1886(h)(5)(A) of the Social Security Act.
p.000375: (2) CHILDREN’S HOSPITAL.—The term ‘‘children’s hospital’’ means a hospital with a Medicare payment
p.000375: agreement and which is excluded from the Medicare inpatient prospective pay- ment system pursuant to section
p.000375: 1886(d)(1)(B)(iii) of the Social Security Act and its accompanying regulations.
p.000375: (3) DIRECT GRADUATE MEDICAL EDUCATION COSTS.—The term ‘‘direct graduate medical education costs’’ has
p.000375: the mean- ing given such term in section 1886(h)(5)(C) of the Social Secu- rity Act.
p.000375: (h) ADDITIONAL PROVISIONS.—
p.000375: (1) IN GENERAL.—The Secretary is authorized to make available up to 25 percent of the total amounts in
p.000375: excess of
p.000375: $245,000,000 appropriated under paragraphs (1) and (2) of sub- section (f), but not to exceed $7,000,000, for
p.000375: payments to hos- pitals qualified as described in paragraph (2), for the direct and indirect expenses
p.000375: associated with operating approved grad- uate medical residency training programs, as described in sub- section (a).
p.000375: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000375: Sec. 340E PUBLIC HEALTH SERVICE ACT 376
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p.000375: January 30, 2020
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p.000375: (2) QUALIFIED HOSPITALS.—
p.000375: (A) IN GENERAL.—To qualify to receive payments under paragraph (1), a hospital shall be a
p.000375: free-standing hospital—
p.000375: (i) with a Medicare payment agreement and that is excluded from the Medicare inpatient hospital pro-
p.000375: spective payment system pursuant to section 1886(d)(1)(B) of the Social Security Act and its accom-
p.000375: panying regulations;
p.000375: (ii) whose inpatients are predominantly individ- uals under 18 years of age;
p.000375: (iii) that has an approved medical residency train- ing program as defined in section 1886(h)(5)(A) of the
p.000375: Social Security Act; and
p.000375: (iv) that is not otherwise qualified to receive pay- ments under this section or section 1886(h) of the So-
p.000375: cial Security Act.
p.000375: (B) ESTABLISHMENT OF RESIDENCY CAP.—In the case of a freestanding children’s hospital that, on the date of
p.000375: en- actment of this subsection, meets the requirements of sub- paragraph (A) but for which the Secretary has
p.000375: not deter- mined an average number of full-time equivalent residents under section 1886(h)(4) of the Social
p.000375: Security Act, the Secretary may establish such number of full-time equiva- lent residents for the purposes
p.000375: of calculating payments under this subsection.
p.000375: (3) PAYMENTS.—Payments to hospitals made under this subsection shall be made in the same manner as payments are
p.000375: made to children’s hospitals, as described in subsections (b) through (e).
p.000375: (4) PAYMENT AMOUNTS.—The direct and indirect payment amounts under this subsection shall be determined
p.000375: using per resident amounts that are no greater than the per resident amounts used for determining direct
p.000375: and indirect payment amounts under subsection (a).
p.000375: (5) REPORTING.—A hospital receiving payments under this subsection shall be subject to the reporting requirements under
p.000375: subsection (b)(3).
p.000375: (6) REMAINING FUNDS.—
p.000375: (A) IN GENERAL.—If the payments to qualified hos- pitals under paragraph (1) for a fiscal year are less
p.000375: than the total amount made available under such paragraph for that fiscal year, any remaining amounts for such
p.000375: fiscal year may be made available to all hospitals participating in the program under this subsection or
p.000375: subsection (a).
p.000375: (B) QUALITY BONUS SYSTEM.—For purposes of distrib- uting the remaining amounts described in subparagraph
p.000375: (A), the Secretary may establish a quality bonus system, whereby the Secretary distributes bonus payments to
p.000375: hos- pitals participating in the program under this subsection or subsection (a) that meet standards specified
p.000375: by the Sec- retary, which may include a focus on quality measurement and improvement, interpersonal and
p.000375: communications skills, delivering patient-centered care, and practicing in
p.000375: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000377: for—
p.000377: (1) loan forgiveness and repayment programs for dentists who—
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p.000377: January 30, 2020
p.000377: (A) agree to practice in designated dental health pro- fessional shortage areas;
p.000377: (B) are dental school graduates who agree to serve as public health dentists for the Federal, State, or local
p.000377: gov- ernment; and
p.000377: (C) agree to—
p.000377: (i) provide services to patients regardless of such patients’ ability to pay; and
p.000377: (ii) use a sliding payment scale for patients who are unable to pay the total cost of services;
p.000377: (2) dental recruitment and retention efforts;
p.000377: (3) grants and low-interest or no-interest loans to help dentists who participate in the medicaid program
p.000377: under title XIX of the Social Security Act (42 U.S.C. 1396 et seq.) to estab- lish or expand practices in
p.000377: designated dental health profes- sional shortage areas by equipping dental offices or sharing in the overhead costs
p.000377: of such practices;
p.000377: (4) the establishment or expansion of dental residency pro- grams in coordination with accredited dental training
p.000377: institu- tions in States without dental schools;
p.000377: (5) programs developed in consultation with State and local dental societies to expand or establish oral health
p.000377: services and facilities in designated dental health professional shortage areas, including services and facilities for
p.000377: children with special needs, such as—
p.000377: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000377: Sec. 340G PUBLIC HEALTH SERVICE ACT 378
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p.000377: January 30, 2020
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p.000377: (A) the expansion or establishment of a community- based dental facility, free-standing dental clinic,
p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
p.000377: (2) ASSURANCES.—The application shall include assurances that the State will meet the requirements of subsection (d)
p.000377: and that the State possesses sufficient infrastructure to manage the activities to be funded through the
p.000377: grant and to evaluate and report on the outcomes resulting from such activities.
p.000377: (d) MATCHING REQUIREMENT.—The Secretary may not make a grant to a State under this section unless that
p.000377: State agrees that, with respect to the costs to be incurred by the State in carrying out the activities for which the
p.000377: grant was awarded, the State will pro- vide non-Federal contributions in an amount equal to not less than 40 percent
p.000377: of Federal funds provided under the grant. The State
p.000377: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000401: Sec. 351A PUBLIC HEALTH SERVICE ACT 402
p.000401:
p.000401: (2) DATE OF APPROVAL.—For purposes of this section, with respect to an application described in paragraph (1),
p.000401: references to the date of approval of such application, or licensure of the product subject to such
p.000401: application, shall mean the later of—
p.000401: (A) the date an application is approved under sub- section (a); or
p.000401: (B) the date of issuance of the interim final rule con- trolling the biological product.
p.000401: SEC. 351A. ø262a¿ ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS. 60
p.000401: (a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (A) IN GENERAL.—The Secretary shall by regulation establish and maintain a list of each biological agent
p.000401: and each toxin that has the potential to pose a severe threat to public health and safety.
p.000401: (B) CRITERIA.—In determining whether to include an agent or toxin on the list under subparagraph (A), the Sec-
p.000401: retary shall—
p.000401: (i) consider—
p.000401: (I) the effect on human health of exposure to the agent or toxin;
p.000401: (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is
p.000401: transferred to humans;
p.000401: (III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent
p.000401: any illness resulting from infection by the agent or toxin; and
p.000401: (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary
p.000401: considers appropriate; and
p.000401: (ii) consult with appropriate Federal departments and agencies and with scientific experts representing
p.000401: appropriate professional groups, including groups with pediatric expertise.
p.000401: (2) BIENNIAL REVIEW.—The Secretary shall review and re- publish the list under paragraph (1) biennially,
p.000401: or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
p.000401: (b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX-
p.000401: INS.—The Secretary shall by regulation provide for—
p.000401: (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including
p.000401: measures to ensure—
p.000401: (A) proper training and appropriate skills to handle such agents and toxins; and
p.000401:
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p.000401: January 30, 2020
p.000401: 60 A program is carried out by the Secretary of Agriculture with respect to each biological agent and
p.000401: each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant
p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
p.000401: Subtitle C of such title (section 221 et seq.; 116 Stat. 657) relates to interagency coordination of the two
p.000401: programs.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000449: (F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions or on a
p.000449: national basis), samples of blood sera from individuals who are included on the list and whose immune system
p.000449: makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such
p.000449: individuals with organ donors,
p.000449: (G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant
p.000449: centers,
p.000449: (H) provide information to physicians and other health professionals regarding organ donation,
p.000449: (I) collect, analyze, and publish data concerning organ do- nation and transplants,
p.000449: (J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement
p.000449: and al- location,
p.000449: (K) work actively to increase the supply of donated organs,
p.000449: (L) submit to the Secretary an annual report containing in- formation on the comparative costs and patient
p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
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p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
p.000449: (1) receiving from interested persons critical comments re- lating to the manner in which the Organ Procurement
p.000449: and Transplantation Network is carrying out the duties of the Net- work under subsection (b); and
p.000449: (2) the consideration by the Secretary of such critical com- ments.
p.000449: SCIENTIFIC REGISTRY
p.000449: SEC. 373. ø274a¿ The Secretary shall, by grant or contract, de- velop and maintain a scientific registry of the
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p.000487: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
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p.000491: (a) may be ex- pended for administrative expenses with respect to the grant. The costs of training
p.000491: individuals to serve in the project involved are not subject to the preceding sentence.
p.000491: (l) RESTRICTIONS ON USE OF GRANT.—To be eligible to receive a grant under this section, an entity must
p.000491: agree that the grant will not be expended—
p.000491: (1) to provide inpatient hospital services;
p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
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p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: 493
p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
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p.000493: As a conforming amendment, section 3106(n) of the Public Law provided that title III of this Act ‘‘is amended by
p.000493: striking the heading for part L’’. This amendment has been executed, but for the convenience of the reader,
p.000493: a designation for a part L is shown above in brackets to indi- cate the probable intent of the Congress that section
p.000493: 399A is not included in part K of title III.
p.000493: For the convenience of the reader, an italicized note follows section 399A above showing the section as
p.000493: it would appear if the amendments described in section 3106 of the Public Law were executed to section 399A.
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: Sec. 399A PUBLIC HEALTH SERVICE ACT 494
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p.000493: January 30, 2020
p.000493:
p.000493: SEC. 399A. ø280d¿ GRANTS FOR SERVICES FOR CHILDREN OF SUB-
p.000493: STANCE ABUSERS. 94
p.000493: (a) ESTABLISHMENT.—
p.000493: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000493: Administra- tion, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000493: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000493: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000493: substance abuser; and
p.000493: (C) to identify such children and such families.
p.000493: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000493: and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted
p.000493: regarding the pro- mulgation of program guidelines and funding priorities under this section.
p.000493: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000493: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000493: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000493: Social Security Act for the State involved—
p.000493: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000493: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000493: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000493: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000493: such payments.
p.000493: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000493: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000493: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000493: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000493: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000493: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000493: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000493: garding the provision of services to the public.
p.000493: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000493: the appli- cant involved agrees to make available (directly or through agree- ments with other entities) to
p.000493: children of substance abusers each of the following services:
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: PUBLIC HEALTH SERVICE ACT
p.000495: Sec. 399A
p.000495:
p.000495: (1) Periodic evaluation of children for developmental, psy- chological, and medical problems.
p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
p.000495: (4) Therapeutic intervention services for children, includ- ing provision of therapeutic child care.
p.000495: (5) Preventive counseling services.
p.000495: (6) Counseling related to the witnessing of chronic vio- lence.
p.000495: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000495: (A) education and special education programs;
p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
p.000495: the State Interagency Coordinating Council, under part C of the Individuals with Disabilities Education Act.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: PUBLIC HEALTH SERVICE ACT
p.000497: Sec. 399A
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p.000497: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
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p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
p.000497: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant involved
p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
p.000497: accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: Sec. 399A PUBLIC HEALTH SERVICE ACT 498
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
p.000501: (ii) the entity will identify children who may be eli- gible for medical assistance under a State program under
p.000501: title XIX or XXI of the Social Security Act.
p.000501: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision
p.000501: of services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000501: agreement shall be waived by the Secretary if the organization does not, in providing health or mental
p.000501: health services, impose a charge or accept reimbursement available from any third- party payor, including
p.000501: reimbursement under any insurance policy or under any Federal or State health benefits pro- gram.
p.000501: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria
p.000501: for a waiver under such clause shall be made without regard to whether the organization accepts
p.000501: voluntary donations re- garding the provision of services to the public.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
p.000501: the family member involved:
p.000501: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000501: professional, or by a trained worker from the community who is supervised by a profes- sional, or by an
p.000501: entity, where the professional or entity provides assurances that the professional or entity is licensed or certified
p.000501: by the State if required and is complying with applicable licen- sure or certification requirements:
p.000501: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services
p.000501: and services for children of substance abusers.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000503:
p.000503:
p.000503:
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
p.000503:
p.000503:
p.000503:
p.000503:
p.000503:
p.000503:
p.000503:
p.000503:
p.000503: January 30, 2020
...

p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000505:
p.000505:
p.000505:
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p.000505:
p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505:
p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000505:
p.000505:
p.000505:
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p.000505:
p.000507: 507
p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
...

p.000511: BREAST CANCER MORTALITY RATES.
p.000511: (a) IN GENERAL.—Subject to subsections (c) and (d), the Sec- retary, acting through the Director of the
p.000511: National Cancer Insti- tute, shall conduct a study for the purpose of determining the fac- tors contributing to
p.000511: the fact that breast cancer mortality rates in the States specified in subsection (b) are elevated
p.000511: compared to rates in other States.
p.000511: (b) RELEVANT STATES.—The States referred to in subsection (a) are Connecticut, Delaware, Maryland, Massachusetts,
p.000511: New Hamp- shire, New Jersey, New York, Rhode Island, Vermont, and the Dis- trict of Columbia.
p.000511: (c) COOPERATION OF STATE.—The Secretary may conduct the study required in subsection (a) in a State only if the
p.000511: State agrees to cooperate with the Secretary in the conduct of the study, includ- ing providing information from
p.000511: any registry operated by the State pursuant to section 399B(a).
p.000511: (d) PLANNING, COMMENCEMENT, AND DURATION.—The Sec- retary shall, during each of the fiscal years 1993 and
p.000511: 1994, develop a plan for conducting the study required in subsection (a). The study shall be initiated by the
p.000511: Secretary not later than fiscal year 1994, and the collection of data under the study may continue through
p.000511: fiscal year 1998.
p.000511: SEC. 399E–1. ø280e–3a¿ NATIONAL CHILDHOOD CANCER REGISTRY.
p.000511: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.000511: awards to State cancer registries to enhance and expand infrastructure to collect information to better
p.000511: understand the epidemiology of cancer in children, adolescents, and young adults. Such registries may be
p.000511: updated to include each occurrence of such cancers within a period of time designated by the Secretary.
p.000511: (b) ACTIVITIES.—The grants described in subsection (a) may be used for—
p.000511: (1) identifying, recruiting, and training potential sources for reporting childhood, adolescent, and young
p.000511: adult cancer cases;
p.000511: (2) developing practices to ensure early inclusion of child- hood, adolescent, and young adult cancer cases in
p.000511: State cancer registries through the use of electronic reporting;
p.000511: (3) collecting and submitting deidentified data to the Cen- ters for Disease Control and Prevention for
p.000511: inclusion in a na- tional database that includes information on childhood, adoles- cent, and young adult cancers;
p.000511: and
p.000511: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000511:
p.000511:
p.000511:
p.000511:
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p.000511:
p.000513: 513
p.000513: PUBLIC HEALTH SERVICE ACT
p.000513: Sec. 399G
p.000513:
p.000513: (4) improving State cancer registries and the database de- scribed in paragraph (3), as appropriate, including
p.000513: to support the early inclusion of childhood, adolescent, and young adult cancer cases.
p.000513: (c) COORDINATION.—To encourage the greatest possible effi- ciency and effectiveness of federally supported
...

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p.000521: Sec. 399H PUBLIC HEALTH SERVICE ACT 522
p.000521:
p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521:
p.000521: January 30, 2020
p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
...

p.000523: Syn- drome and Fetal Alcohol Effect (referred to in this subsection as the ‘‘Task Force’’) to foster
p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
p.000523: hol Effect, including programs and research concerning education and public awareness for relevant service
p.000523: pro- viders, school-age children, women at-risk, and the general public, medical diagnosis, interventions for
p.000523: women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and
p.000523: beneficial services for indi- viduals with Fetal Alcohol Syndrome and Fetal Alcohol Ef- fect and their families;
p.000523: (B) coordinate its efforts with the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the
p.000523: De- partment of Health and Human Services; and
p.000523: (C) report on a biennial basis to the Secretary and rel- evant committees of Congress on the current and planned
p.000523: activities of the participating agencies.
p.000523: (4) TIME FOR APPOINTMENT.—The members of the Task Force shall be appointed by the Secretary not later
p.000523: than 6 months after the date of enactment of this part.
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000523:
p.000523:
p.000523:
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p.000523: Sec. 399I PUBLIC HEALTH SERVICE ACT 524
p.000523:
p.000523: SEC. 399I. ø280f–1¿ ELIGIBILITY.
p.000523: To be eligible to receive a grant, or enter into a cooperative agreement or contract under this part, an
p.000523: entity shall—
p.000523: (1) be a State, Indian tribal government, local government, scientific or academic institution, or nonprofit
p.000523: organization; and
p.000523: (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such
p.000523: information as the Secretary may prescribe, including a description of the ac- tivities that the entity intends to
p.000523: carry out using amounts re- ceived under this part.
p.000523: SEC. 399J. ø280f–2¿ AUTHORIZATION OF APPROPRIATIONS.
p.000523: (a) IN GENERAL.—There are authorized to be appropriated to carry out this part, $27,000,000 for each of
p.000523: the fiscal years 1999 through 2003.
p.000523: (b) TASK FORCE.—From amounts appropriated for a fiscal year under subsection (a), the Secretary may use
p.000523: not to exceed
p.000523: $2,000,000 of such amounts for the operations of the National Task Force under section 399H(d).
p.000523: SEC. 399K. ø280f–3¿ SUNSET PROVISION.
p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
p.000523:
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p.000523:
p.000523:
p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
p.000525: families, including patient education regarding asthma management, family education on asthma
p.000525: management, and the distribution of materials, including displays and videos, to reinforce concepts
p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
p.000525: or high rate of hos- pitalization or emergency room visits for asthma (relative to the average
p.000525: asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate
p.000525: a high prevalence of childhood asthma or high asthma-related mortality may include data from Fed- eral, State, or
p.000525: local vital statistics, claims data under title XIX or XXI of the Social Security Act, other public health
p.000525: statistics or surveys, or other data that the Secretary, in consultation with the Director of the
p.000525: Centers for Disease Control and Prevention, deems appropriate.
p.000525: (3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a
p.000525: public or nonprofit private entity (including a State or political subdivision of a State), or a consortium
p.000525: of any of such entities.
p.000525: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—An el- igible entity shall identify in the plan submitted
p.000525: as part of an ap- plication for a grant under this section how the entity will coordi- nate operations
p.000525: and activities under the grant with—
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p.000525: January 30, 2020
p.000525: 103 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and paragraph
p.000525: (3) probably should be redesignated as paragraphs (3) and (4), respectively. See sec- tion 501 of Public Law 106–310
p.000525: (114 Stat. 1113).
p.000525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: Sec. 399L PUBLIC HEALTH SERVICE ACT 526
p.000525:
p.000525: (1) other programs operated in the State that serve chil- dren with asthma, including any such
p.000525: programs operated under title V, XIX, or XXI of the Social Security Act; and
p.000525: (2) one or more of the following—
p.000525: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000525: such Act;
p.000525: (B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);
p.000525: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000525: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000525: (D) local public and private elementary or secondary schools; or
p.000525: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000525: U.S.C. 1437a).
p.000525: (c) EVALUATION.—An eligible entity that receives a grant under this section shall submit to the Secretary an evaluation
p.000525: of the oper- ations and activities carried out under the grant that includes—
p.000525: (1) a description of the health status outcomes of children assisted under the grant;
p.000525: (2) an assessment of the utilization of asthma-related health care services as a result of
p.000525: activities carried out under the grant;
p.000525: (3) the collection, analysis, and reporting of asthma data according to guidelines prescribed by the
p.000525: Director of the Cen- ters for Disease Control and Prevention; and
p.000525: (4) such other information as the Secretary may require.
p.000525: (d) PREFERENCE FOR STATES THAT ALLOW STUDENTS TO SELF- ADMINISTER MEDICATION TO TREAT ASTHMA AND
p.000525: ANAPHYLAXIS.—
p.000104: 104
p.000104: (1) PREFERENCE.—The Secretary, in making any grant under this section or any other grant that is
p.000104: asthma-related (as determined by the Secretary) to a State, shall give pref- erence to any State that
p.000104: satisfies the following:
p.000104: (A) IN GENERAL.—The State must require that each public elementary school and secondary school in that
p.000104: State will grant to any student in the school an authoriza- tion for the self-administration of medication to treat
p.000104: that student’s asthma or anaphylaxis, if—
p.000104: (i) a health care practitioner prescribed the medi- cation for use by the student during school hours and
p.000104: instructed the student in the correct and responsible use of the medication;
p.000104: (ii) the student has demonstrated to the health care practitioner (or such practitioner’s designee) and
...

p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
p.000527: INFANTS, AND YOUNG CHILDREN.
p.000527: (a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND
p.000527: SYS-
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: 529
p.000529: PUBLIC HEALTH SERVICE ACT
p.000529: Sec. 399M
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p.000529: January 30, 2020
p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
p.000529: (including medical homes for children), and in programs mandated by part C of the Individuals with Disabilities
p.000529: Education Act, which offer programs specifically designed to meet the unique language and communication
p.000529: needs of deaf and hard-of-hearing children.
p.000529: (B) Information provided to families should be accu- rate, comprehensive, up-to-date, and evidence-based,
p.000529: as appropriate, to allow families to make important decisions for their children in a timely manner, including
p.000529: decisions with respect to the full range of assistive hearing tech- nologies and communications modalities, as
p.000529: appropriate.
p.000529: (C) Programs and systems under this paragraph shall offer mechanisms that foster family-to-family and deaf and
p.000529: hard-of-hearing consumer-to-family supports.
p.000529: (2) To continue to provide technical support to States, through one or more technical resource centers, to
p.000529: assist in fur- ther developing and enhancing State early hearing detection and intervention programs.
p.000529: (3) To identify or develop efficient models (educational and medical) to ensure that children who are identified
p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
p.000529:
p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
p.000529: child hearing screening, evaluation (including audiologic, medical, and language acquisition
p.000529: evalua- tions), diagnosis, and intervention services;
p.000529: (ii) to conduct applied research related to new- born, infant, and young child hearing screening, eval-
p.000529: uation, and intervention programs and outcomes;
p.000529: (iii) to ensure quality monitoring of hearing screening, evaluation, and intervention programs and
p.000529: systems for newborns, infants, and young children; and
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p.000529: January 30, 2020
p.000529: (iv) to support newborn, infant, and young child hearing screening, evaluation, and intervention pro-
p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
p.000529: screening, evaluation, and intervention programs and systems;
p.000529: (iii) to collect data and report on newborn, infant, and young child hearing screening, evaluation, diag- nosis,
p.000529: and intervention programs and systems for ap- plied research, program evaluation, and policy im-
p.000529: provement;
p.000529: (iv) to identify the causes and risk factors for con- genital hearing loss;
p.000529: (v) to study the effectiveness of newborn, infant, and young child hearing screening, audiologic and
p.000529: medical evaluations and intervention programs and systems by assessing the health, intellectual and so-
p.000529: cial developmental, cognitive, and hearing status of these children at school age; and
p.000529: (vi) to promote the integration and interoper- ability of data regarding early hearing loss across mul-
p.000529: tiple sources to increase the flow of information be- tween clinical care and public health settings,
p.000529: includ- ing the ability of States and territories to exchange and share data.
p.000529: (2) NATIONAL INSTITUTES OF HEALTH.—The Director of the National Institutes of Health, acting through the
p.000529: Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
p.000529: this section, continue a pro- gram of research and development on the efficacy of new screening techniques
p.000529: and technology, including clinical studies of screening methods, studies on efficacy of intervention, and
p.000529: related research.
p.000529: (c) COORDINATION AND COLLABORATION.—
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: 531
p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
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p.000531: January 30, 2020
p.000531: (1) IN GENERAL.—In carrying out programs under this sec- tion, the Administrator of the Health Resources and
p.000531: Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the
p.000531: National Institutes of Health shall collaborate and consult with—
p.000531: (A) other Federal agencies;
p.000531: (B) State and local agencies, including agencies re- sponsible for early intervention services pursuant to
p.000531: title XIX of the Social Security Act (Medicaid Early and Peri- odic Screening, Diagnosis and Treatment
p.000531: Program); title XXI of the Social Security Act (State Children’s Health In- surance Program); title V of the
p.000531: Social Security Act (Ma- ternal and Child Health Block Grant Program); and part C of the Individuals with
p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
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p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
p.000531: of this subsection), by striking ‘‘(3)’’ and all that follows through ‘‘decision making’’ and inserting
p.000531: ‘‘The term ‘medical evaluation’ means key components performed by a physician including history,
p.000531: examination, and medical decisionmaking’’’. Based on the structure of this provision of defined terms, the
p.000531: paragraph (3) enumerator was likely mistakenly left out of the inserted matter. It was re-inserted to reflect
p.000531: the probable intent of Congress.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: PUBLIC HEALTH SERVICE ACT
p.000533: Sec. 399N
p.000533:
p.000533: (1) STATEWIDE NEWBORN AND INFANT HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—For
p.000533: the purpose of carrying out subsection (a), there are authorized to be appropriated to the Health Resources and
p.000533: Services Ad- ministration $17,818,000 for fiscal year 2018, $18,173,800 for fiscal year 2019, $18,628,145
p.000533: for fiscal year 2020, $19,056,592 for fiscal year 2021, and $19,522,758 for fiscal year 2022.
p.000533: (2) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND AP- PLIED RESEARCH; CENTERS FOR DISEASE CONTROL AND
p.000533: PREVEN- TION.—For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated
p.000533: to the Centers for Disease Control and Prevention $10,800,000 for fiscal year 2018,
p.000533: $11,026,800 for fiscal year 2019, $11,302,470 for fiscal year 2020, $11,562,427 for fiscal year 2021, and
p.000533: $11,851,488 for fis- cal year 2022.
p.000533: (3) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND AP- PLIED RESEARCH; NATIONAL INSTITUTE ON DEAFNESS AND
p.000533: OTHER COMMUNICATION DISORDERS.—For the purpose of carrying out subsection (b)(2), there are authorized to be
p.000533: appropriated to the National Institute on Deafness and Other Communication Dis- orders such sums as may be
p.000533: necessary for fiscal years 2011 through 2015.
p.000533: SEC. 399N. ø280g–2¿ CHILDHOOD MALIGNANCIES.
p.000533: (a) IN GENERAL.—The Secretary, acting as appropriate through the Director of the Centers for Disease Control and
p.000533: Prevention and the Director of the National Institutes of Health, shall study envi- ronmental and other risk
p.000533: factors for childhood cancers (including skeletal malignancies, leukemias, malignant tumors of the central
p.000533: nervous system, lymphomas, soft tissue sarcomas, and other malig- nant neoplasms) and carry out projects to improve
p.000533: outcomes among children with childhood cancers and resultant secondary conditions, including limb loss, anemia,
p.000533: rehabilitation, and palliative care. Such projects shall be carried out by the Secretary directly and
p.000533: through awards of grants or contracts.
p.000533: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) in- clude—
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p.000533: (1) the expansion of current demographic data collection and population surveillance efforts to include
p.000533: childhood cancers nationally;
p.000533: (2) the development of a uniform reporting system under which treating physicians, hospitals, clinics, and
p.000533: States report the diagnosis of childhood cancers, including relevant associ- ated epidemiological data; and
p.000533: (3) support for the National Limb Loss Information Center to address, in part, the primary and secondary needs
p.000533: of per- sons who experience childhood cancers in order to prevent or minimize the disabling nature of these
p.000533: cancers.
p.000533: (c) COORDINATION OF ACTIVITIES.—The Secretary shall assure that activities under this section are
p.000533: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities focused on
p.000533: childhood cancers and limb loss.
p.000533: (d) DEFINITION.—For purposes of this section, the term ‘‘child- hood cancer’’ refers to a spectrum of
p.000533: different malignancies that
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
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p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
p.000551: (ii) the expansion and further development of the National Dissemination Center for Children with Dis-
p.000551: abilities, so that such Center can more effectively con- duct outreach to new and expecting parents and pro-
p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
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p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
p.000553: organizations delivering population-based services, including primary care professionals, health care
p.000553: systems, professional societies, employers, community organizations, non-profit organizations, schools,
p.000553: governmental pub- lic health agencies, Indian tribes, tribal organizations and urban Indian organizations,
p.000553: medical groups, Congress and other policy- makers. Community preventive services include any policies, pro-
p.000553: grams, processes or activities designed to affect or otherwise affect- ing health at the population level.
p.000553: (b) DUTIES.—The duties of the Task Force shall include—
p.000553: (1) the development of additional topic areas for new rec- ommendations and interventions related to
p.000553: those topic areas, including those related to specific populations and age groups, as well as the social, economic
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p.000553: its work with the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices,
p.000553: including the examination of how each task force’s recommendations interact at the nexus of clinic and
p.000553: community.
p.000553: (e) OPERATION.—In carrying out the duties under subsection (b), the Task Force shall not be subject to the
p.000553: provisions of Appen- dix 2 of title 5, United States Code.
p.000553: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary
p.000553: for each fiscal year to carry out the activities of the Task Force.
p.000553: SEC. 399V. ø280g–11¿ GRANTS TO PROMOTE POSITIVE HEALTH BEHAV- IORS AND OUTCOMES.
p.000553: (a) GRANTS AUTHORIZED.—The Director of the Centers for Dis- ease Control and Prevention, in collaboration with
p.000553: the Secretary, shall award grants to eligible entities to promote positive health behaviors and outcomes
p.000553: for populations in medically underserved communities through the use of community health workers.
p.000553: (b) USE OF FUNDS.—Grants awarded under subsection (a) shall be used to support community health workers—
p.000553: (1) to educate, guide, and provide outreach in a community setting regarding health problems prevalent in
p.000553: medically un- derserved communities, particularly racial and ethnic minority populations;
p.000553: (2) to educate and provide guidance regarding effective strategies to promote positive health behaviors and
p.000553: discourage risky health behaviors;
p.000553: (3) to educate and provide outreach regarding enrollment in health insurance including the Children’s Health
p.000553: Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act and
p.000553: Medicaid under title XIX of such Act;
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: PUBLIC HEALTH SERVICE ACT
p.000555: Sec. 399V
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p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
p.000555: organizations in order to increase access to quality healthcare services and to eliminate duplicative care; or
p.000555: (5) to educate, guide, and provide home visitation services regarding maternal health and prenatal care.
p.000555: (c) APPLICATION.—Each eligible entity that desires to receive a grant under subsection (a) shall submit an
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p.000557: January 30, 2020
p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
p.000557: (B) may include entities such as hospital associations, primary care practice-based research networks, health pro-
p.000557: fessional societies, State primary care associations, State licensing boards, organizations with a contract
p.000557: with the Secretary under section 1153 of the Social Security Act, consumer groups, and other appropriate
p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
p.000557: (1) HUB ACTIVITIES.—Hubs established under a grant under subsection (b) shall—
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p.000569: (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer
p.000569: surveillance, exposure assessment, pediatric health, pollution control, com- munity outreach, health
p.000569: education, laboratory sampling and analysis, spatial mapping, and informatics;
p.000569: (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary
p.000569: deter- mines appropriate;
p.000569: (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes
p.000569: of such clus- ters, and the actions taken to address such clusters; and
p.000569: (5) provide technical assistance for investigating cancer clusters to State and local health departments through
p.000569: existing programs, such as the Epi-Aids program of the Centers for Dis- ease Control and Prevention and the Assessments
p.000569: of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry.
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p.000569: January 30, 2020 As Amended Through P.L. 116-94,
p.000569: Enacted December 20, 2019
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p.000569: Sec. 399W PUBLIC HEALTH SERVICE ACT
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p.000569: PART Q—PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
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p.000570: SEC. 399W. ø280h¿ GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL ACTIVITY.
p.000570: (a) IN GENERAL.—The Secretary, acting though the Director of the Centers for Disease Control and Prevention,
p.000570: shall award com- petitive grants to States and political subdivisions of States for the development and
p.000570: implementation of State and community-based intervention programs to promote good nutrition and physical
p.000570: ac- tivity in children and adolescents.
p.000570: (b) ELIGIBILITY.—To be eligible to receive a grant under this section a State or political subdivision of a
p.000570: State shall prepare and submit to the Secretary an application at such time, in such man- ner, and containing such
p.000570: information as the Secretary may require, including a plan that describes—
p.000570: (1) how the applicant proposes to develop a comprehensive program of school- and community-based approaches to encour-
p.000570: age and promote good nutrition and appropriate levels of phys- ical activity with respect to children or
p.000570: adolescents in local communities;
p.000570: (2) the manner in which the applicant shall coordinate with appropriate State and local authorities, such as
p.000570: State and local school departments, State departments of health, chronic disease directors, State directors of programs
p.000570: under section 17 of the Child Nutrition Act of 1966, 5-a-day coordinators, gov- ernors councils for
p.000570: physical activity and good nutrition, and State and local parks and recreation departments; and
p.000570: (3) the manner in which the applicant will evaluate the ef- fectiveness of the program carried out under this section.
p.000570: (c) USE OF FUNDS.—A State or political subdivision of a State shall use amount received under a grant under
p.000570: this section to—
p.000570: (1) develop, implement, disseminate, and evaluate school- and community-based strategies in States to
p.000570: reduce inactivity and improve dietary choices among children and adolescents;
p.000570: (2) expand opportunities for physical activity programs in school- and community-based settings; and
p.000570: (3) develop, implement, and evaluate programs that pro- mote good eating habits and physical activity including
p.000570: oppor- tunities for children with cognitive and physical disabilities.
p.000570: (d) TECHNICAL ASSISTANCE.—The Secretary may set-aside an amount not to exceed 10 percent of the amount
p.000570: appropriated for a fiscal year under subsection (h) to permit the Director of the Cen- ters for Disease
p.000570: Control and Prevention to—
p.000570: (1) provide States and political subdivisions of States with technical support in the development and
p.000570: implementation of programs under this section; and
p.000570: (2) disseminate information about effective strategies and interventions in preventing and treating obesity
p.000570: through the promotion of good nutrition and physical activity.
p.000570: (e) LIMITATION ON ADMINISTRATIVE COSTS.—Not to exceed 10 percent of the amount of a grant awarded to
p.000570: the State or political subdivision under subsection (a) for a fiscal year may be used by the State or
p.000570: political subdivision for administrative expenses.
p.000570: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000571: Sec. 399Y
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p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
p.000571: (4) conduct research to establish the prevalence, con- sequences, and costs of childhood obesity
p.000571: and its effects in adulthood;
p.000571: (5) identify behaviors and risk factors that contribute to obesity;
p.000571: (6) evaluate materials and programs to provide nutrition education to parents and teachers of children in
p.000571: child care or pre-school and the food service staff of such child care and pre- school entities; and
p.000571: (7) evaluate materials and programs that are designed to educate and encourage physical activity in child
p.000571: care and pre- school facilities.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Y. ø280h–2¿ EDUCATION CAMPAIGN.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000571: and in collabora- tion with national, State, and local partners, physical activity orga- nizations, nutrition
p.000571: experts, and health professional organizations, shall develop a national public campaign to promote and
p.000571: educate children and their parents concerning—
p.000571: (1) the health risks associated with obesity, inactivity, and poor nutrition;
p.000571: (2) ways in which to incorporate physical activity into daily living; and
p.000571: (3) the benefits of good nutrition and strategies to improve eating habits.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
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p.000571: January 30, 2020 As Amended Through P.L. 116-94,
p.000571: Enacted December 20, 2019
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p.000571: (1) better identify and assess patients with obesity or an eating disorder or patients at-risk of
p.000571: becoming obese or devel- oping an eating disorder;
p.000571: (2) counsel, refer, or treat patients with obesity or an eat- ing disorder; and
p.000571: (3) educate patients and their families about effective strategies to improve dietary habits and
p.000571: establish appropriate levels of physical activity.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
p.000571: (a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
p.000571: (1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘‘comprehensive primary health services’’ means the core
p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
p.000571: (B) MENTAL HEALTH.—Mental health and substance use disorder assessments, crisis intervention, counseling,
p.000571: treatment, and referral to a continuum of services includ- ing emergency psychiatric care, community
p.000571: support pro- grams, inpatient care, and outpatient programs.
p.000571: (2) MEDICALLY UNDERSERVED CHILDREN AND ADOLES- CENTS.—
p.000571: (A) IN GENERAL.—The term ‘‘medically underserved children and adolescents’’ means a population of children
p.000571: and adolescents who are residents of an area designated as a medically underserved area or a health
p.000571: professional shortage area by the Secretary.
p.000571: (B) CRITERIA.—The Secretary shall prescribe criteria for determining the specific shortages of personal
p.000571: health services for medically underserved children and adoles- cents under subparagraph (A) that shall—
p.000571: (i) take into account any comments received by the Secretary from the chief executive officer of a State
p.000571: and local officials in a State; and
p.000571: (ii) include factors indicative of the health status of such children and adolescents of an area, including the
p.000571: ability of the residents of such area to pay for health services, the accessibility of such services,
p.000571: the availability of health professionals to such children
p.000571: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: PUBLIC HEALTH SERVICE ACT
p.000573: Sec. 399Z–1
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p.000573: and adolescents, and other factors as determined ap- propriate by the Secretary.
p.000573: (3) SCHOOL-BASED HEALTH CENTER.—The term ‘‘school- based health center’’ means a health clinic that—
p.000573: (A) meets the definition of a school-based health cen- ter under section 2110(c)(9)(A) of the Social
p.000573: Security Act and is administered by a sponsoring facility (as defined in section 2110(c)(9)(B) of the Social Security
p.000573: Act);
p.000573: (B) provides, at a minimum, comprehensive primary health services during school hours to children and adoles-
p.000573: cents by health professionals in accordance with estab- lished standards, community practice, reporting
p.000573: laws, and other State laws, including parental consent and notifica- tion laws that are not inconsistent
p.000573: with Federal law; and
p.000573: (C) does not perform abortion services.
p.000573: (b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants for the costs of the operation of school-based health
p.000573: centers (referred to in this section as ‘‘SBHCs’’) that meet the requirements of this section.
p.000573: (c) APPLICATIONS.—To be eligible to receive a grant under this section, an entity shall—
p.000573: (1) be an SBHC (as defined in subsection (a)(3)); and
p.000573: (2) submit to the Secretary an application at such time, in such manner, and containing—
p.000573: (A) evidence that the applicant meets all criteria nec- essary to be designated an SBHC;
p.000573: (B) evidence of local need for the services to be pro- vided by the SBHC;
p.000573: (C) an assurance that—
p.000573: (i) SBHC services will be provided to those chil- dren and adolescents for whom parental or guardian
p.000573: consent has been obtained in cooperation with Fed- eral, State, and local laws governing health care serv- ice
p.000573: provision to children and adolescents;
p.000573: (ii) the SBHC has made and will continue to make every reasonable effort to establish and maintain col-
p.000573: laborative relationships with other health care pro- viders in the catchment area of the SBHC;
p.000573: (iii) the SBHC will provide on-site access during the academic day when school is in session and 24-
p.000573: hour coverage through an on-call system and through its backup health providers to ensure access to
p.000573: serv- ices on a year-round basis when the school or the SBHC is closed;
p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
p.000573: school personnel, such as administrators, teachers, nurses, counselors, and support personnel, as well
p.000573: as with other community providers co-located at the school;
p.000573: (v) the SBHC sponsoring facility assumes all re- sponsibility for the SBHC administration, operations, and
p.000573: oversight; and
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
p.000573:
p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
p.000573: (A) Communities that have evidenced barriers to pri- mary health care and mental health and substance
p.000573: use disorder prevention services for children and adolescents.
p.000573: (B) Communities with high per capita numbers of chil- dren and adolescents who are uninsured, underinsured, or enrolled
p.000573: in public health insurance programs.
p.000573: (C) Populations of children and adolescents that have historically demonstrated difficulty in accessing health
p.000573: and mental health and substance use disorder prevention serv- ices.
p.000573: (2) The Secretary may give consideration to whether an applicant has received a grant under subsection
p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
p.000573: (2) upon a showing of good cause, waive the requirement that the SBHC provide all required comprehensive
p.000573: primary health services for a designated period of time to be deter- mined by the Secretary.
p.000573: (f) USE OF FUNDS.—
p.000573: (1) FUNDS.—Funds awarded under a grant under this sec- tion—
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p.000573: (A) may be used for—
p.000573: (i) acquiring and leasing equipment (including the costs of amortizing the principle of, and paying inter- est
p.000573: on, loans for such equipment);
p.000573: (ii) providing training related to the provision of required comprehensive primary health services and
p.000573: additional health services;
p.000573: (iii) the management and operation of health cen- ter programs;
p.000573: (iv) the payment of salaries for physicians, nurses, and other personnel of the SBHC; and
p.000573: (B) may not be used to provide abortions.
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p.000575: (i) EVALUATION.—The Secretary shall develop and implement a plan for evaluating SBHCs and monitoring quality
p.000575: performance under the awards made under this section.
p.000575: (j) AGE APPROPRIATE SERVICES.—An eligible entity receiving funds under this section shall only provide age
p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
p.000575: (A) is at risk for, shows early signs of, or has been di- agnosed with a mental illness, including a serious
p.000575: emo- tional disturbance; and
p.000575: (B) may benefit from infant and early childhood inter- vention or treatment programs or specialized preschool or
p.000575: elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise
p.000575: but would benefit from further applied development.
p.000575: (2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a human services agency or nonprofit institution that—
p.000575: (A) employs licensed mental health professionals who have specialized training and experience in infant
p.000575: and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the
p.000575: appropriate State agency, as applicable, to provide for children from in- fancy to 12 years of age mental health
p.000575: promotion, inter- vention, or treatment services; and
p.000575: (B) provides services or programs described in sub- section (a) that are evidence-based or that have
p.000575: been sci- entifically demonstrated to show promise but would benefit from further applied development.
p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
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p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
p.000577: State epidemiological data for children and adults with autism spectrum disorder and other developmental
p.000577: disabilities. An eligible entity shall assist with the development and coordination of State autism
p.000577: spectrum disorder and other developmental disability surveil- lance efforts within a region. In making such
p.000577: awards, the Sec- retary may provide direct technical assistance in lieu of cash.
p.000577: (2) DATA STANDARDS.—In submitting epidemiological data to the Secretary pursuant to paragraph (1), an
p.000577: eligible entity shall report data according to guidelines prescribed by the Di- rector of the Centers for Disease
p.000577: Control and Prevention, after consultation with relevant State, local, and Tribal public health
p.000577: officials, private sector developmental disability re- searchers, and advocates for individuals with autism
p.000577: spectrum disorder and other developmental disabilities.
p.000577: (3) ELIGIBILITY.—To be eligible to receive an award under paragraph (1), an entity shall be a public or
p.000577: nonprofit private entity (including a health department of a State or a political subdivision of a
p.000577: State, a university, any other educational in- stitution, an Indian tribe, or a tribal organization), and submit
p.000577: to the Secretary an application at such time, in such manner, and containing such information as the
p.000577: Secretary may require.
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: (b) CENTERS OF EXCELLENCE IN AUTISM SPECTRUM DISORDER EPIDEMIOLOGY.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: shall, subject to the availability of appropriations, award grants or cooperative agreements for the
p.000577: establishment or support of re- gional centers of excellence in autism spectrum disorder and other
p.000577: developmental disabilities epidemiology for the purpose of collecting and analyzing information on the
p.000577: number, inci- dence, correlates, and causes of autism spectrum disorder and other developmental disabilities
p.000577: for children and adults.
p.000577: (2) REQUIREMENTS.—To be eligible to receive a grant or co- operative agreement under paragraph (1), an entity shall
p.000577: sub- mit to the Secretary an application containing such agreements and information as the Secretary may require,
p.000577: including an agreement that the center to be established or supported under the grant or cooperative agreement shall
p.000577: operate in accordance with the following:
p.000577: (A) The center will collect, analyze, and report autism spectrum disorder and other developmental disability data
p.000577: according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention,
p.000577: after con- sultation with State, local, and Tribal public health offi- cials, private sector developmental
p.000577: disability researchers, advocates for individuals with autism spectrum disorder, and advocates for
p.000577: individuals with other developmental disabilities.
p.000577: (B) The center will develop or extend an area of spe- cial research expertise (including genetics,
p.000577: epigenetics, and epidemiological research related to environmental expo- sures), immunology, and other
p.000577: relevant research specialty areas.
p.000577: (C) The center will identify eligible cases and controls through its surveillance system and conduct research
p.000577: into factors which may cause or increase the risk of autism spectrum disorder and other developmental
p.000577: disabilities.
p.000577: (c) FEDERAL RESPONSE.—The Secretary shall coordinate the Federal response to requests for assistance from State
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p.000579: Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.
p.000579: (e) SUNSET.—This section shall not apply after September 30, 2024.
p.000579: SEC. 399BB. ø280i–1¿ AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION.
p.000579: (a) PURPOSE.—It is the purpose of this section—
p.000579: (1) to increase awareness, reduce barriers to screening and diagnosis, promote evidence-based interventions for
p.000579: individuals with autism spectrum disorder and other developmental dis- abilities, and train professionals to
p.000579: utilize valid and reliable screening tools to diagnose or rule out and provide evidence- based
p.000579: interventions for individuals with autism spectrum dis- order and other developmental disabilities across
p.000579: their life- span; and
p.000579: (2) to conduct activities under this section with a focus on an interdisciplinary approach (as defined in
p.000579: programs devel- oped under section 501(a)(2) of the Social Security Act) that will also focus on specific
p.000579: issues for children who are not re- ceiving an early diagnosis and subsequent interventions.
p.000579: (b) IN GENERAL.—The Secretary shall, subject to the avail- ability of appropriations, establish and evaluate
p.000579: activities to—
p.000579: (1) provide culturally competent information and education on autism spectrum disorder and other developmental
p.000579: disabil- ities to increase public awareness of developmental milestones;
p.000579: (2) promote research into the development and validation of reliable screening tools for individuals with autism
p.000579: spectrum disorder and other developmental disabilities and disseminate information regarding those screening
p.000579: tools;
p.000579: (3) promote early screening of individuals at higher risk for autism spectrum disorder and other developmental
p.000579: disabil- ities as early as practicable, given evidence-based screening techniques and interventions;
p.000579: (4) promote evidence-based screening techniques and inter- ventions for individuals with autism spectrum disorder
p.000579: and other developmental disabilities across their lifespan;
p.000579: (5) increase the number of individuals who are able to con- firm or rule out a diagnosis of autism spectrum
p.000579: disorder and other developmental disabilities;
p.000579: (6) increase the number of individuals able to provide evi- dence-based interventions for individuals diagnosed
p.000579: with au- tism spectrum disorder or other developmental disabilities; and
p.000579: (7) promote the use of evidence-based interventions for in- dividuals at higher risk for autism spectrum
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p.000579: Education and the Secretary of Agriculture, shall, subject to the availability of appropriations, provide culturally
p.000579: competent information re- garding autism spectrum disorder and other developmental disabilities, risk
p.000579: factors, characteristics, identification, diag- nosis or rule out, and evidence-based interventions to meet the
p.000579: needs of individuals with autism spectrum disorder and other
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: Sec. 399BB PUBLIC HEALTH SERVICE ACT 580
p.000579:
p.000579: developmental disabilities across their lifespan and the needs of their families through—
p.000579: (A) Federal programs, including—
p.000579: (i) the Head Start program;
p.000579: (ii) the Early Start program;
p.000579: (iii) the Healthy Start program;
p.000579: (iv) programs under the Child Care and Develop- ment Block Grant Act of 1990;
p.000579: (v) programs under title XIX of the Social Security Act (particularly the Medicaid Early and Periodic
p.000579: Screening, Diagnosis and Treatment Program);
p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
...

p.000581: individuals.
p.000581: (C) INFORMATION.—Information under subparagraph (A)(ii) shall be provided through—
p.000581: (i) toll-free telephone numbers;
p.000581: (ii) Internet websites;
p.000581: (iii) mailings; or
p.000581: (iv) such other means as the Governor may re- quire.
p.000581: (d) TOOLS.—
p.000581: (1) IN GENERAL.—To promote the use of valid and reliable screening tools for autism spectrum disorder and other
p.000581: devel- opmental disabilities, the Secretary shall develop a curriculum for continuing education to assist
p.000581: individuals in recognizing the need for valid and reliable screening tools and the use of such tools.
p.000581: (2) COLLECTION, STORAGE, COORDINATION, AND AVAIL- ABILITY.—The Secretary, in collaboration with the
p.000581: Secretary of Education, shall provide for the collection, storage, coordina- tion, and public availability of
p.000581: tools described in paragraph (1), educational materials and other products that are used by the Federal programs
p.000581: referred to in subsection (c)(1)(A), as well as—
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p.000581: (A) programs authorized under the Developmental Disabilities Assistance and Bill of Rights Act of 2000;
p.000581: (B) early intervention programs or interagency coordi- nating councils authorized under part C of the Individuals with
p.000581: Disabilities Education Act; and
p.000581: (C) children with special health care needs programs authorized under title V of the Social Security Act.
p.000581: (3) REQUIRED SHARING.—In establishing mechanisms and entities under this subsection, the Secretary, and the
p.000581: Secretary of Education, shall ensure the sharing of tools, materials, and products developed under this
p.000581: subsection among entities re- ceiving funding under this section.
p.000581: (e) DIAGNOSIS.—
p.000581: (1) TRAINING.—The Secretary, in coordination with activi- ties conducted under title V of the Social
p.000581: Security Act, shall, subject to the availability of appropriations, expand existing
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000583: the goals outlined in such strategic plan.
p.000583: (c) MEMBERSHIP.—
p.000583: (1) FEDERAL MEMBERSHIP.—The Committee shall be com- posed of the following Federal members—
p.000583: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000583: Sec. 399CC PUBLIC HEALTH SERVICE ACT 584
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p.000583: (A) the Director of the Centers for Disease Control and Prevention;
p.000583: (B) the Director of the National Institutes of Health, and the Directors of such national research
p.000583: institutes of the National Institutes of Health as the Secretary deter- mines appropriate;
p.000583: (C) the heads of such other agencies as the Secretary determines appropriate, such as the Administration
p.000583: for Community Living, Administration for Children and Fami- lies, the Centers for Medicare & Medicaid Services,
p.000583: the Food and Drug Administration, and the Health Resources and Services Administration; and
p.000583: (D) representatives of other Federal Governmental agencies that serve individuals with autism spectrum
p.000583: dis- order such as the Department of Education, the Depart- ment of Labor, the Department of Justice, the
p.000583: Department of Veterans Affairs, the Department of Housing and Urban Development, and the Department of Defense.
p.000583: (2) NON-FEDERAL MEMBERS.—Not more than 1⁄2, but not fewer than 1⁄3, of the total membership of the Committee,
p.000583: shall be composed of non-Federal public members to be appointed by the Secretary, of which—
p.000583: (A) at least three such members shall be individuals with a diagnosis of autism spectrum disorder;
p.000583: (B) at least three such members shall be parents or legal guardians of an individual with an autism
p.000583: spectrum disorder; and
p.000583: (C) at least three such members shall be representa- tives of leading research, advocacy, and service
p.000583: organiza- tions for individuals with autism spectrum disorder.
p.000583: (3) PERIOD OF APPOINTMENT; VACANCIES.—
p.000583: (A) PERIOD OF APPOINTMENT FOR NON-FEDERAL MEM- BERS.—Non-Federal members shall serve for a term of 4
p.000583: years, and may be reappointed for one additional 4-year term.
p.000583: (B) VACANCIES.—A vacancy on the Committee shall be filled in the manner in which the original appointment was
...

p.000585: such date.
p.000585: SEC. 399DD. ø280i–3¿ REPORTS TO CONGRESS.
p.000585: (a) PROGRESS REPORT.—
p.000585: (1) IN GENERAL.— 108Not later than 4 years after the date of enactment of the Autism CARES Act of 2019, the Secretary,
p.000585: in coordination with the Secretary of Education and the Sec- retary of Defense, shall prepare and submit
p.000585: to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce
p.000585: Committee of the House of Rep- resentatives, and make publicly available, including through posting on the
p.000585: Internet Web site of the Department of Health and Human Services, a progress report on activities related to
p.000585: autism spectrum disorder and other developmental disabilities.
p.000585: (2) CONTENTS.—The report submitted under subsection (a) shall contain—
p.000585: (A) a description of the progress made in imple- menting the provisions of the Autism CARES Act of
p.000585: 2019;
p.000585: (B) a description of the amounts expended on the im- plementation of the amendments made by the Autism
p.000585: CARES Act of 2019;
p.000585: (C) information on the incidence and prevalence of au- tism spectrum disorder, including available information on the
p.000585: prevalence of autism spectrum disorder among chil- dren and adults, and identification of any changes
p.000585: over time with respect to the incidence and prevalence of au- tism spectrum disorder;
p.000585: (D) information on the average age of diagnosis for children with autism spectrum disorder and other
p.000585: disabil- ities, including how that age may have changed over the 4-year period beginning on the date of
p.000585: enactment of the Autism CARES Act of 2019 and, as appropriate, how this age varies across population
p.000585: subgroups;
p.000585: (E) information on the average age for intervention for individuals diagnosed with autism spectrum disorder and
p.000585: other developmental disabilities, including how that age may have changed over the 4-year period beginning on the
p.000585: date of enactment of the Autism CARES Act of 2019 and, as appropriate, how this age varies across population
p.000585: sub- groups;
p.000585: (F) information on the average time between initial screening and then diagnosis or rule out for
p.000585: individuals with autism spectrum disorder or other developmental dis- abilities, as well as information on the
p.000585: average time be- tween diagnosis and evidence-based intervention for indi- viduals with autism spectrum
p.000585: disorder or other develop-
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p.000585: 108 Casing of heading for paragraph (1) so in law.
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000585: order;
p.000585: (B) an overview of policies and programs relevant to the health and well-being of individuals with autism spec-
p.000585: trum disorder, including an identification of existing Fed- eral laws, regulations, policies, research, and
p.000585: programs;
p.000585: (C) recommendations on establishing best practices guidelines to ensure interdisciplinary coordination between all
p.000585: relevant service providers receiving Federal funding;
p.000585: (D) comprehensive approaches to improving health outcomes and well-being for individuals with autism spec-
p.000585: trum disorder, including—
p.000585: (i) community-based behavioral supports and interventions;
p.000585: (ii) nutrition, recreational, and social activities;
p.000585: and
p.000585: (iii) personal safety services related to public safe-
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p.000585: January 30, 2020
p.000585: ty agencies or the criminal justice system for such in- dividuals; and
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000587: PUBLIC HEALTH SERVICE ACT
p.000587: Sec. 399HH
p.000587:
p.000587: (E) recommendations that seek to improve health out- comes for such individuals, including across their lifespan, by
p.000587: addressing—
p.000587: (i) screening and diagnosis of children and adults;
p.000587: (ii) behavioral and other therapeutic approaches;
p.000587: (iii) primary and preventative care;
p.000587: (iv) communication challenges;
p.000587: (v) aggression, self-injury, elopement, and other behavioral issues;
p.000587: (vi) emergency room visits and acute care hos- pitalization;
p.000587: (vii) treatment for co-occurring physical and men- tal health conditions;
p.000587: (viii) premature mortality;
p.000587: (ix) medical practitioner training; and
p.000587: (x) caregiver mental health.
p.000587: SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000587: (a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RE- SEARCH PROGRAM.—To carry out section 399AA, there is
p.000587: authorized to be appropriated $23,100,000 for each of fiscal years 2020 through 2024.
p.000587: (b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVEN- TION.—To carry out section 399BB, there is authorized
p.000587: to be appro- priated $50,599,000 for each of fiscal years 2020 through 2024.
p.000587: (c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN OTHER PROGRAMS.—To carry out sections 399CC and
p.000587: 409C, there are authorized to be appropriated $296,000,000 for each of fiscal years 2020 through 2024.
p.000587: PART S—HEALTH CARE QUALITY PROGRAMS
p.000587: Subpart I—National Strategy for Quality Improvement in Health Care
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p.000587: SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
p.000587: (a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
p.000587: (1) NATIONAL STRATEGY.—The Secretary, through a trans- parent collaborative process, shall establish a national
p.000587: strategy to improve the delivery of health care services, patient health outcomes, and population health.
p.000587: (2) IDENTIFICATION OF PRIORITIES.—
p.000587: (A) IN GENERAL.—The Secretary shall identify national priorities for improvement in developing the strategy
p.000587: under paragraph (1).
p.000587: (B) REQUIREMENTS.—The Secretary shall ensure that priorities identified under subparagraph (A) will—
p.000587: (i) have the greatest potential for improving the health outcomes, efficiency, and patient-centeredness of
p.000587: health care for all populations, including children and vulnerable populations;
p.000587: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000587: (ii) identify areas in the delivery of health care services that have the potential for rapid improvement in
p.000587: the quality and efficiency of patient care;
p.000587: (iii) address gaps in quality, efficiency, compara- tive effectiveness information (taking into consider-
p.000587: ation the limitations set forth in subsections (c) and
p.000587: (d) of section 1182 of the Social Security Act), and health outcomes measures and data aggregation tech-
p.000587: niques;
p.000587: (iv) improve Federal payment policy to emphasize quality and efficiency;
p.000587: (v) enhance the use of health care data to improve quality, efficiency, transparency, and outcomes;
p.000587: (vi) address the health care provided to patients with high-cost chronic diseases;
p.000587: (vii) improve research and dissemination of strate- gies and best practices to improve patient safety and
p.000587: reduce medical errors, preventable admissions and re- admissions, and health care-associated infections;
p.000587: (viii) reduce health disparities across health dis- parity populations (as defined in section 485E) and ge-
p.000587: ographic areas; and
p.000587: (ix) address other areas as determined appropriate by the Secretary.
p.000587: (C) CONSIDERATIONS.—In identifying priorities under subparagraph (A), the Secretary shall take into
p.000587: consider- ation the recommendations submitted by the entity with a contract under section 1890(a) of the Social
p.000587: Security Act and other stakeholders.
p.000587: (D) COORDINATION WITH STATE AGENCIES.—The Sec- retary shall collaborate, coordinate, and consult with State
p.000587: agencies responsible for administering the Medicaid pro- gram under title XIX of the Social Security Act
p.000587: and the Children’s Health Insurance Program under title XXI of such Act with respect to developing and
p.000587: disseminating strategies, goals, models, and timetables that are con- sistent with the national priorities
p.000587: identified under sub- paragraph (A).
p.000587: (b) STRATEGIC PLAN.—
p.000587: (1) IN GENERAL.—The national strategy shall include a comprehensive strategic plan to achieve the priorities
p.000587: described in subsection (a).
p.000587: (2) REQUIREMENTS.—The strategic plan shall include provi- sions for addressing, at a minimum, the following:
p.000587: (A) Coordination among agencies within the Depart- ment, which shall include steps to minimize duplication of
p.000587: efforts and utilization of common quality measures, where available. Such common quality measures shall be meas-
p.000587: ures identified by the Secretary under section 1139A or 1139B of the Social Security Act or endorsed under
p.000587: section 1890 of such Act.
p.000587: (B) Agency-specific strategic plans to achieve national priorities.
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p.000591: eligible hos- pitals.
p.000591: (b) REPORT TO THE SECRETARY.—As determined appropriate by the Secretary, eligible hospitals and patient
p.000591: safety organizations working with those hospitals shall report to the Secretary on the processes employed
p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: (C) an accredited dental education, dental hygiene, or postdoctoral dental education program; or
p.000593: (D) a non-profit community-based organization that partners with public and private non-profit entities,
p.000593: such as an academic institution, to facilitate the provision of dental services to underserved populations.
p.000593: SEC. 399LL–1. ø280k–1¿ RESEARCH-BASED DENTAL CARIES DISEASE MANAGEMENT.
p.000593: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000593: shall award dem- onstration grants to eligible entities to demonstrate the effective- ness of research-based
p.000593: dental caries disease management activities.
p.000593: (b) ELIGIBILITY.—To be eligible for a grant under this section, an entity shall—
p.000593: (1) be a community-based provider of dental services (as defined by the Secretary), including a
p.000593: Federally-qualified health center, a clinic of a hospital owned or operated by a State (or by an
p.000593: instrumentality or a unit of government within a State), a State or local department of health, a dental
p.000593: pro- gram of the Indian Health Service, an Indian tribe or tribal or- ganization, or an urban Indian organization (as
p.000593: such terms are defined in section 4 of the Indian Health Care Improvement Act), a health system provider,
p.000593: a private provider of dental services, medical, dental, public health, nursing, nutrition edu- cational
p.000593: institutions, or national organizations involved in im- proving children’s oral health; and
p.000593: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000593: Sec- retary may require.
p.000593: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000593:
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p.000593: Sec. 399LL–2 PUBLIC HEALTH SERVICE ACT 594
p.000593:
p.000593: (c) USE OF FUNDS.—A grantee shall use amounts received under a grant under this section to demonstrate
p.000593: the effectiveness of research-based dental caries disease management activities.
p.000593: (d) USE OF INFORMATION.—The Secretary shall, as practicable and appropriate, utilize information generated from
p.000593: grantees under this section in planning and implementing the oral health edu- cation campaign and action
p.000593: for dental health program under sec- tion 399LL.
p.000593: SEC. 399LL–2. ø280k–2¿ AUTHORIZATION OF APPROPRIATIONS.
p.000593: There is authorized to be appropriated to carry out this part, such sums as may be necessary.
p.000593:
p.000593: PART U—EMPLOYER-BASED WELLNESS PROGRAM
p.000593:
p.000593: SEC. 399MM. ø280l¿ TECHNICAL ASSISTANCE FOR EMPLOYER-BASED WELLNESS PROGRAMS.
p.000593: In order to expand the utilization of evidence-based prevention and health promotion approaches in the workplace,
p.000593: the Director shall—
p.000593: (1) provide employers (including small, medium, and large employers, as determined by the Director) with
p.000593: technical as- sistance, consultation, tools, and other resources in evaluating such employers’
...

p.000637: disorders in the indicated populations and the relationship of DES to the diseases or dis- orders:
p.000637: (1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant,
p.000637:
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p.000637: January 30, 2020
p.000637: 5 So in law. Paragraph (3) probably should be subsection (b).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000637: Sec. 404A PUBLIC HEALTH SERVICE ACT 638
p.000637:
p.000637: the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of
p.000637: the immune system, including autoimmune disease).
p.000637: (2) In the case of women exposed to DES in utero, the inci- dence of clear cell cancer (including recurrences), the
p.000637: long-term health effects of such cancer, and the effects of treatments for such cancer.
p.000637: (3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders
p.000637: (including im- pairments of the reproductive and autoimmune systems).
p.000637: (4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and
p.000637: disorders.
p.000637: (d) For purposes of this section, an individual shall be consid- ered to have been exposed to DES in utero
p.000637: if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938)
p.000637: administered to the biological mother of the indi- vidual.
p.000637: OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH
p.000637: SEC. 404A. 6 ø283c¿ (a) There is established within the Office of the Director of NIH an office to be known
p.000637: as the Office of Behav- ioral and Social Sciences Research (in this section referred to as the ‘‘Office’’).
p.000637: The Office shall be headed by a director, who shall be appointed by the Director of NIH.
p.000637: (b)(1) With respect to research on the relationship between human behavior and the development, treatment,
p.000637: and prevention of medical conditions, the Director of the Office shall—
p.000637: (A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
p.000637: (B) identify projects of behavioral and social sciences re- search that should be conducted or supported
p.000637: by the national research institutes, and develop such projects in cooperation with such institutes.
p.000637: (2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent
p.000637: behavior, suicide, and homelessness. Such research does not include neurobiological re- search, or research
p.000637: in which the behavior of an organism is ob- served for the purpose of determining activity at the cellular or
p.000637: mo- lecular level.
p.000637: CHILDREN’S VACCINE INITIATIVE
p.000637: SEC. 404B. ø283d¿
p.000637: The Secretary, in consultation with the Director of the Na- tional Vaccine Program under title XXI and acting
p.000637: through the Di- rectors of the National Institute for Allergy and Infectious Dis- eases, the Eunice Kennedy
p.000637: Shriver National Institute of Child Health and Human Development, the National Institute for Aging, and other
p.000637: public and private programs, shall carry out activities, which shall be consistent with the global Children’s
p.000637: Vaccine Initia- tive, to develop affordable new and improved vaccines to be used in the United States and in
p.000637: the developing world that will increase
p.000637:
p.000637:
p.000637:
p.000637: January 30, 2020
p.000637: 6 Section 404 was struck by section 101(b)(2) of Public Law 106–525 (114 Stat. 2501).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000639: PUBLIC HEALTH SERVICE ACT
p.000639: Sec. 404C
p.000639:
p.000639: the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities,
p.000639: the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to
p.000639: deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and
p.000639: syringes, and that protect against a larger number of diseases.
p.000639: PLAN FOR USE OF ANIMALS IN RESEARCH
p.000639: SEC. 404C. ø283e¿ (a) The Director of NIH, after consultation with the committee established under subsection
p.000639: (e), shall prepare a plan—
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p.000641: each of the national research institutes involved in research with respect to muscular dystrophy and
p.000641: representatives of all other Federal departments and agencies whose pro- grams involve health functions or
p.000641: responsibilities relevant to such diseases, including the Centers for Disease Control
p.000641: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000641: Sec. 404E PUBLIC HEALTH SERVICE ACT 642
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p.000641: January 30, 2020
p.000641:
p.000641: and Prevention, the Health Resources and Services Admin- istration, the Food and Drug Administration, and the
p.000641: Ad- ministration for Community Living and representatives of other governmental agencies that serve
p.000641: children and adults with muscular dystrophy, including the Department of Education and the Social Security
p.000641: Administration; and
p.000641: (B) 1⁄3 of such members shall be public members, in- cluding a broad cross section of persons affected with
p.000641: mus- cular dystrophies including parents or legal guardians, af- fected individuals, researchers, and clinicians.
p.000641: Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an
p.000641: unlimited number of terms if reappointed.
p.000641: (3) CHAIR.—
p.000641: (A) IN GENERAL.—With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the
p.000641: principal advisor to the Secretary, the Assistant Sec- retary for Health, and the Director of NIH, and shall
p.000641: pro- vide advice to the Director of the Centers for Disease Con- trol and Prevention, the Commissioner of Food and
p.000641: Drugs, and to the heads of other relevant agencies. The Coordi- nating Committee shall select the Chair
p.000641: for a term not to exceed 2 years.
p.000641: (B) APPOINTMENT.—The Chair of the Committee shall be appointed by and be directly responsible to the
p.000641: Sec- retary.
p.000641: (4) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PROVISIONS.—The following shall apply with respect to the
p.000641: Co- ordinating Committee:
p.000641: (A) The Coordinating Committee shall receive nec- essary and appropriate administrative support from the
p.000641: Department of Health and Human Services.
p.000641: (B) The Coordinating Committee shall meet as appro- priate as determined by the Secretary, in consultation with
...

p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000667: samples.
p.000667: (d) PUBLIC INPUT.—The Director shall under subsection (a)(1) provide for means through which the public can
p.000667: obtain information
p.000667: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000667:
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p.000667: Sec. 409D PUBLIC HEALTH SERVICE ACT 668
p.000667:
p.000667: on the existing and planned programs and activities of the Na- tional Institutes of Health with respect
p.000667: to autism spectrum dis- order and through which the Director can receive comments from the public regarding
p.000667: such programs and activities.
p.000667: PEDIATRIC RESEARCH INITIATIVE
p.000667: SEC. 409D. ø284h¿ (a) ESTABLISHMENT.—The Secretary shall establish within the Office of the Director of
p.000667: NIH a Pediatric Re- search Initiative (referred to in this section as the ‘‘Initiative’’) to conduct and
p.000667: support research that is directly related to diseases, disorders, and other conditions in children. The
p.000667: Initiative shall be headed by the Director of NIH.
p.000667: (b) PURPOSE.—The purpose of the Initiative is to provide funds to enable the Director of NIH—
p.000667: (1) to increase support for pediatric biomedical research within the National Institutes of Health to realize
p.000667: the expand- ing opportunities for advancement in scientific investigations and care for children;
p.000667: (2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in
p.000667: the areas that the Director deems most promising; and
p.000667: (3) in coordination with the Food and Drug Administra- tion, to increase the development of adequate pediatric
p.000667: clinical trials and pediatric use information to promote the safer and more effective use of prescription
p.000667: drugs in the pediatric popu- lation.
p.000667: (c) DUTIES.—In carrying out subsection (b), the Director of NIH shall—
p.000667: (1) consult with the Director of the Eunice Kennedy Shriv-
p.000667: er National Institute of Child Health and Human Development and the other national research institutes, in considering
p.000667: their requests for new or expanded pediatric research efforts, and consult with the Administrator of the
p.000667: Health Resources and Services Administration and other advisors as the Director de- termines to be appropriate;
p.000667: (2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of
p.000667: grants, and between basic and clinical research so long as the assistance is directly related to the
p.000667: illnesses and conditions of children; and
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p.000667: January 30, 2020
p.000667: (3) be responsible for the oversight of any newly appro- priated Initiative funds and annually report to
p.000667: Congress and the public on the extent of the total funds obligated to conduct or support pediatric research
p.000667: across the National Institutes of Health, including the specific support and research awards al- located through
p.000667: the Initiative.
p.000667: (d) NATIONAL PEDIATRIC RESEARCH NETWORK.—
p.000667: (1) NETWORK.—In carrying out the Initiative, the Director of NIH, in collaboration with the national
p.000667: research institutes and national centers that carry out activities involving pedi- atric research, shall
p.000667: support a National Pediatric Research Network in order to more effectively support pediatric research
p.000667: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000667:
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p.000669: PUBLIC HEALTH SERVICE ACT
p.000669: Sec. 409D
p.000669:
p.000669: and optimize the use of Federal resources. Such National Pedi- atric Research Network may be comprised of, as
p.000669: appropriate—
p.000669: (A) the pediatric research consortia receiving awards under paragraph (2); or
p.000669: (B) other consortia, centers, or networks focused on pe- diatric research that are recognized by the Director of NIH
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p.000673: ‘‘Clinical Re- search Curriculum Awards’’) to institutions for the develop- ment and support of programs
p.000673: of core curricula for training clinical investigators, including medical students. Such core curricula may
p.000673: include training in areas such as the following:
p.000673: (A) Analytical methods, biostatistics, and study design.
p.000673: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000673:
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p.000673: Sec. 409I PUBLIC HEALTH SERVICE ACT 674
p.000673:
p.000673: (B) Principles of clinical pharmacology and pharmaco- kinetics.
p.000673: (C) Clinical epidemiology.
p.000673: (D) Computer data management and medical informatics.
p.000673: (E) Ethical and regulatory issues.
p.000673: (F) Biomedical writing.
p.000673: (2) APPLICATIONS.—An application for a grant under this subsection shall be submitted by an individual
p.000673: institution or a consortium of institutions at such time as the Director may re- quire. An institution may submit only
p.000673: one such application.
p.000673: (3) LIMITATIONS.—Grants under this subsection shall be for terms of up to 5 years and may be renewable.
p.000673: SEC. 409I. ø284m¿ PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 14
p.000673: (a) LIST OF PRIORITY ISSUES IN PEDIATRIC THERAPEUTICS.—
p.000673: (1) IN GENERAL.—Not later than one year after the date of the enactment of the Best Pharmaceuticals for Children Act of
p.000673: 2007, the Secretary, acting through the Director of the Na- tional Institutes of Health and in
p.000673: consultation with the Com- missioner of Food and Drugs and experts in pediatric research, shall develop and
p.000673: publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or
p.000673: indica- tions that require study. The list shall be revised every three years.
p.000673: (2) CONSIDERATION OF AVAILABLE INFORMATION.—In devel- oping and prioritizing the list under paragraph (1),
p.000673: the Sec- retary—
p.000673: (A) shall consider—
p.000673: (i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic deter- minants of
p.000673: drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
p.000673: (ii) particular pediatric diseases, disorders or con- ditions where more complete knowledge and testing of
p.000673: therapeutics, including drugs and biologics, and identi- fication of biomarkers for such diseases, disorders, or
p.000673: conditions, may be beneficial in pediatric populations; and
p.000673: (iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including
p.000673: research networks and trained pediatric investigators; and
p.000673: (B) may consider the availability of qualified counter- measures (as defined in section 319F–1), security
p.000673: counter- measures (as defined in section 319F–2), and qualified pandemic or epidemic products (as
p.000673: defined in section 319F–3) to address the needs of pediatric populations, in consultation with the
p.000673: Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.
p.000673:
p.000673:
p.000673:
p.000673:
p.000673:
p.000673: January 30, 2020
p.000673: 14 Section 16 of Public Law 107–109 (115 Stat. 1421) requires the Comptroller General of the United States, in
p.000673: consultation with the Secretary of Health and Human Services, to submit to Congress a report that
p.000673: relates to section 409I and to section 505A of the Federal Food, Drug, and Cosmetic Act. The report is
p.000673: required to be submitted not later than October 1, 2006.
p.000673: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000689: (2) ADMINISTRATION.—The Director of NIH shall carry out this subsection through the Director of the National Cancer In-
p.000689: stitute and in collaboration with any other agencies that the Director determines to be appropriate.
p.000689: (b) GERALDINE FERRARO CANCER EDUCATION PROGRAM.—
p.000689: (1) IN GENERAL.—The Secretary shall direct the appro- priate agency within the Department of Health and
p.000689: Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information
p.000689: and education for patients and the general public with respect to blood can- cer, and particularly with
p.000689: respect to the treatment of leukemia, lymphoma, and multiple myeloma.
p.000689: (2) ADMINISTRATION.—The Agency determined by the Sec- retary under paragraph (1) shall carry out this
p.000689: subsection in collaboration with private health organizations that have na- tional education and patient
p.000689: assistance programs on blood-re- lated cancers.
p.000689: SEC. 417E. ø285a–11¿ PEDIATRIC CANCER RESEARCH, AWARENESS, AND SURVIVORSHIP.
p.000689: (a) CHILDREN’S CANCER BIOREPOSITORIES.—
p.000689: (1) AWARD.—The Secretary, acting through the Director of NIH, may make awards to an entity or entities
p.000689: described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and
p.000689: demographic information of chil- dren, adolescents, and young adults with selected cancer subtypes (and
p.000689: their recurrences) for which current treatments are least effective, in order to achieve a better
p.000689: understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of
p.000689: treatments for such cancers.
p.000689: (2) USE OF FUNDS.—Amounts received under an award under paragraph (1) may be used to carry out the following:
p.000689: (A) Collect and store high-quality, donated biospeci- mens and associated clinical and demographic information on
p.000689: children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children,
p.000689: adoles- cents, and young adults with cancer enrolled in clinical trials for whom current treatments are
p.000689: least effective. Ac- tivities under this subparagraph may include storage of biospecimens and associated
p.000689: clinical and demographic data at existing biorepositories supported by the National Can- cer Institute.
p.000689: (B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated
p.000689: clinical and demographic data from children, adolescents, and young adults with cancer for the
p.000689: purposes of research by scientists and qualified health care professionals.
p.000689: (C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical
p.000689: and demographic data from researchers and other quali- fied health care professionals.
p.000689: (D) Provide access to biospecimens and clinical and de- mographic data from children, adolescents, and
p.000689: young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—
p.000689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000691: 691
p.000691: PUBLIC HEALTH SERVICE ACT
p.000691: Sec. 417E
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p.000691: (i) consistent with the procedures established pur- suant to subparagraph (C);
p.000691: (ii) only to the extent permitted by applicable Fed- eral and State law; and
p.000691: (iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy
p.000691: law, at minimum.
p.000691: (3) NO REQUIREMENT.—No child, adolescent, or young adult with cancer shall be required under this
p.000691: subsection to contribute a specimen to a biorepository or share clinical or de- mographic data.
p.000691: (4) APPLICATION; CONSIDERATIONS.—
p.000691: (A) APPLICATION.—To be eligible to receive an award under paragraph (1) an entity shall submit an application to
p.000691: the Secretary at such a time, in such manner, and con- taining such information as the Secretary may reasonably
p.000691: require.
p.000691: (B) CONSIDERATIONS.—In evaluating applications sub- mitted under subparagraph (A), the Secretary shall con-
p.000691: sider the existing infrastructure of the entity that would allow for the timely capture of biospecimens
p.000691: and related clinical and demographic information for children, adoles- cents, and young adults with cancer
p.000691: for whom current treatments are least effective.
p.000691: (5) PRIVACY PROTECTIONS AND INFORMED CONSENT.—
p.000691: (A) IN GENERAL.—The Secretary may not make an award under paragraph (1) to an entity unless the Sec-
p.000691: retary ensures that such entity—
p.000691: (i) collects biospecimens and associated clinical and demographic information only from participants who
p.000691: have given their informed consent in accordance with Federal and State law; and
p.000691: (ii) protects personal privacy to the extent re- quired by applicable Federal and State law, at min-
p.000691: imum.
p.000691: (B) INFORMED CONSENT.—The Secretary shall ensure biospecimens and associated clinical and demographic in-
p.000691: formation are collected with informed consent, as described in subparagraph (A)(i).
p.000691: (6) GUIDELINES AND OVERSIGHT.—The Secretary shall de- velop and disseminate appropriate guidelines for
p.000691: the develop- ment and maintenance of the biorepositories supported under this subsection, including
p.000691: appropriate oversight, to facilitate further research on select cancer subtypes (and their
p.000691: recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).
p.000691: (7) COORDINATION.—To encourage the greatest possible ef- ficiency and effectiveness of federally supported efforts with
p.000691: re- spect to the activities described in this subsection, the Sec- retary shall ensure the appropriate
p.000691: coordination of programs supported under this section with existing federally supported cancer registry
p.000691: programs and the activities under section 399E–1, as appropriate.
p.000691: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000691: Sec. 417E PUBLIC HEALTH SERVICE ACT 692
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p.000691: (8) SUPPLEMENT NOT SUPPLANT.—Funds provided under this subsection shall be used to supplement, and not
p.000691: supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.
...

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p.000699: January 30, 2020
p.000699: INFORMATION AND EDUCATION
p.000699: SEC. 420. ø285b–2¿ The Director of the Institute shall collect, identify, analyze, and disseminate on a timely
p.000699: basis, through publi- cations and other appropriate means, to patients, families of pa- tients, physicians
p.000699: and other health professionals, and the general public, information on research, prevention, diagnosis, and
p.000699: treat- ment of heart, blood vessel, lung, and blood diseases, the mainte- nance of health to reduce the
p.000699: incidence of such diseases, and on the use of blood and blood products and the management of blood re-
p.000699: sources. In carrying out this section, the Director of the Institute shall place special emphasis upon the
p.000699: utilization of collaborative ef- forts with both the public and private sectors to—
p.000699: (1) increase the awareness and knowledge of health care professionals and the public regarding the
p.000699: prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and
p.000699: (2) develop and disseminate to health professionals, pa- tients and patient families, and the public
p.000699: information de- signed to encourage adults and children to adopt healthful practices concerning the prevention
p.000699: of such diseases.
p.000699: NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD RESOURCES PROGRAM
p.000699: SEC. 421. ø285b–3¿ (a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources
p.000699: Program (hereafter in this subpart referred to as the ‘‘Program’’ may provide for—
p.000699: (A) investigation into the epidemiology, etiology, and pre- vention of all forms and aspects of heart,
p.000699: blood vessel, lung, and blood diseases, including investigations into the social, en- vironmental, behavioral,
p.000699: nutritional, biological, and genetic de- terminants and influences involved in the epidemiology, eti- ology, and
p.000699: prevention of such diseases;
p.000699: (B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and
p.000699: abnor- mal heart, blood vessel, lung, and blood phenomena;
p.000699: (C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers)
p.000699: used in, and approaches to, the diagnosis, treatment (including the pro- vision of emergency medical services), and
p.000699: prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such
p.000699: diseases;
p.000699: (D) establishment of programs that will focus and apply scientific and technological efforts involving
p.000699: the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood
p.000699: diseases with emphasis on the refine- ment, development, and evaluation of technological devices that will
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p.000699: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000699: Sec. 421 PUBLIC HEALTH SERVICE ACT 700
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p.000699: bilitative approaches to, and emergency medical services for, such diseases;
p.000699: (F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects
p.000699: of the management of blood resources in the United States, including the collection, preservation, fractionation,
p.000699: and distribution of blood and blood products;
p.000699: (G) the education (including continuing education) and training of scientists, clinical investigators, and
p.000699: educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs
p.000699: respecting heart, blood vessel, lung, and blood diseases and blood resources;
p.000699: (H) public and professional education relating to all as- pects of such diseases, including the
p.000699: prevention of such dis- eases, and the use of blood and blood products and the man- agement of blood
p.000699: resources;
p.000699: (I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of
p.000699: children (includ- ing cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and
p.000699: Cooley’s anemia, and hemophilic dis- eases) and for the development and demonstration of diag- nostic,
p.000699: treatment, and preventive approaches to such diseases; and
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p.000699: (J) establishment of programs for study, research, develop- ment, demonstrations and evaluation of emergency
p.000699: medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.
p.000699: (2) The Program shall be coordinated with other national re- search institutes to the extent that they
p.000699: have responsibilities re- specting such diseases and shall give special emphasis to the con- tinued
p.000699: development in the Institute of programs related to the causes of stroke and to effective coordination of such
p.000699: programs with related stroke programs in the National Institute of Neurological and Communicative Disorders
p.000699: and Stroke. The Director of the In- stitute, with the advice of the advisory council for the Institute,
p.000699: shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
p.000699: (b) In carrying out the Program, the Director of the Institute, under policies established by the Director of
p.000699: NIH—
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p.000701: prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services)
p.000701: for heart and blood ves- sel diseases;
p.000701: (B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment and rehabilitation methods (including methods of providing emergency medical
p.000701: services) for lung diseases (in-
p.000701: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000701: Sec. 422 PUBLIC HEALTH SERVICE ACT 702
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p.000701: cluding bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children);
p.000701: (C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and
p.000701: research into blood, in the use of blood products and in the management of blood re- sources; and
p.000701: (D) three centers for basic and clinical research into, train- ing in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment (including genetic studies, intrauterine environ- ment studies, postnatal studies, heart
p.000701: arrhythmias, and ac- quired heart disease and preventive cardiology) for cardio- vascular diseases in
p.000701: children.
p.000701: (2) The centers developed under paragraph (1) shall, in addi- tion to being utilized for research, training,
p.000701: and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood
p.000701: diseases:
p.000701: (A) Programs to develop improved methods of detecting in- dividuals with a high risk of developing
p.000701: cardiovascular, pul- monary, and blood diseases.
p.000701: (B) Programs to develop improved methods of intervention against those factors which cause individuals to have
p.000701: a high risk of developing such diseases.
p.000701: (C) Programs to develop health professions and allied health professions personnel highly skilled in the
p.000701: prevention of such diseases.
p.000701: (D) Programs to develop improved methods of providing emergency medical services for persons with such diseases.
p.000701: (E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and
p.000701: treat- ment of such diseases and the maintenance of health to reduce the incidence of such diseases and
p.000701: information programs for the public respecting the prevention and early diagnosis and treatment of such
p.000701: diseases and the maintenance of health.
p.000701: (3) The research, training, and demonstration activities carried out through any such center may relate to any one or
p.000701: more of the diseases referred to in paragraph (1) of this subsection.
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p.000705: Coordinating Committee for the purpose of performing the tasks described in subsection (a). 23
p.000705: SEC. 424C. ø285b–7c¿ TUBERCULOSIS.
p.000705: (a) IN GENERAL.—The Director of the National Institutes of Health may expand, intensify, and coordinate
p.000705: research and devel- opment and related activities of the Institutes with respect to tu- berculosis
p.000705: including activities toward the goal of eliminating such disease.
p.000705: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000705: (1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis;
p.000705: (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and
p.000705: (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods
p.000705: to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.
p.000705: SEC. 425. ø285b–8¿ CONGENITAL HEART DISEASE.
p.000705: (a) IN GENERAL.—The Director of the Institute may expand, in- tensify, and coordinate research and related activities
p.000705: of the Insti- tute with respect to congenital heart disease, which may include congenital heart disease
p.000705: research with respect to—
p.000705: (1) causation of congenital heart disease, including genetic causes;
p.000705: (2) long-term outcomes in individuals with congenital heart disease, including infants, children,
p.000705: teenagers, adults, and elderly individuals;
p.000705: (3) diagnosis, treatment, and prevention;
p.000705:
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p.000705: 22 So in law. The section designation lacks a period. See section 521 of Public Law 106–310 (114 Stat.
p.000705: 1116).
p.000705: 23 Section 425 was repealed by section 103(b)(20) of Public Law 109–482 (120 Stat. 3688).
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000707: 707
p.000707: PUBLIC HEALTH SERVICE ACT
p.000707: Sec. 427
p.000707:
p.000707: (4) studies using longitudinal data and retrospective anal- ysis to identify effective treatments and outcomes
p.000707: for individ- uals with congenital heart disease; and
p.000707: (5) identifying barriers to life-long care for individuals with congenital heart disease.
p.000707: (b) COORDINATION OF RESEARCH ACTIVITIES.—The Director of the Institute may coordinate research efforts
p.000707: related to congenital heart disease among multiple research institutions and may de- velop research networks.
p.000707: (c) MINORITY AND MEDICALLY UNDERSERVED COMMUNITIES.— In carrying out the activities described in this section,
p.000707: the Director of the Institute shall consider the application of such research and other activities to minority and
p.000707: medically underserved commu- nities.
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p.000713: January 30, 2020
p.000713: JUVENILE DIABETES
p.000713: SEC. 434A. ø285c–9¿ (a) LONG-TERM EPIDEMIOLOGY STUDIES.—
p.000713: The Director of the Institute shall conduct or support long-term ep- idemiology studies in which individuals with
p.000713: or at risk for type 1, or juvenile, diabetes are followed for 10 years or more. Such studies shall investigate
p.000713: the causes and characteristics of the disease and its complications.
p.000713: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000715: PUBLIC HEALTH SERVICE ACT
p.000715: Sec. 436
p.000715:
p.000715: (b) CLINICAL TRIAL INFRASTRUCTURE/INNOVATIVE TREATMENTS FOR JUVENILE DIABETES.—The Secretary, acting through the
p.000715: Direc- tor of the National Institutes of Health, shall support regional clin- ical research centers for the
p.000715: prevention, detection, treatment, and cure of juvenile diabetes.
p.000715: (c) PREVENTION OF TYPE 1 DIABETES.—The Secretary, acting through the appropriate agencies, shall provide for a
p.000715: national effort to prevent type 1 diabetes. Such effort shall provide for a combina- tion of increased efforts in
p.000715: research and development of prevention strategies, including consideration of vaccine development, coupled with
p.000715: appropriate ability to test the effectiveness of such strategies in large clinical trials of children and young
p.000715: adults.
p.000715: Subpart 4—National Institute of Arthritis and Musculoskeletal and Skin Diseases
p.000715: PURPOSE OF THE INSTITUTE
p.000715: SEC. 435. ø285d¿ The general purpose of the National Institute of Arthritis and Musculoskeletal and Skin Diseases
p.000715: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and sup- port of research and training,
p.000715: the dissemination of health informa- tion, and other programs with respect to arthritis and musculo- skeletal
p.000715: and skin diseases (including sports-related disorders), with particular attention to the effect of these diseases on
p.000715: children.
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p.000715: January 30, 2020
p.000715: NATIONAL ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES PROGRAM
p.000715: SEC. 436. ø285d–1¿ (a) The Director of the Institute, with the advice of the Institute’s advisory
p.000715: council, shall prepare and trans- mit to the Director of NIH a plan for a national arthritis and mus- culoskeletal
p.000715: and skin diseases program to expand, intensify, and coordinate the activities of the Institute respecting
p.000715: arthritis and musculoskeletal and skin diseases. The plan shall include such comments and recommendations as
p.000715: the Director of the Institute de- termines appropriate. The plan shall place particular emphasis upon expanding
p.000715: research into better understanding the causes and the development of effective treatments for arthritis
p.000715: affecting chil- dren. The Director of the Institute shall periodically review and re- vise such plan and shall
p.000715: transmit any revisions of such plan to the Director of NIH.
p.000715: (b) Activities under the national arthritis and musculoskeletal and skin diseases program shall be coordinated
p.000715: with the other na- tional research institutes to the extent that such institutes have re- sponsibilities respecting
p.000715: arthritis and musculoskeletal and skin dis- eases, and shall, at least, provide for—
p.000715: (1) investigation into the epidemiology, etiology, and pre- vention of all forms of arthritis and
p.000715: musculoskeletal and skin diseases, including sports-related disorders, primarily through the support of basic
p.000715: research in such areas as immunology, ge- netics, biochemistry, microbiology, physiology, bioengineering, and any
p.000715: other scientific discipline which can contribute impor- tant knowledge to the treatment and understanding of
p.000715: arthri- tis and musculoskeletal and skin diseases;
p.000715: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000715: Sec. 437 PUBLIC HEALTH SERVICE ACT 716
p.000715:
p.000715: (2) research into the development, trial, and evaluation of techniques, drugs, and devices used in the
p.000715: diagnosis, treat- ment, including medical rehabilitation, and prevention of ar- thritis and musculoskeletal and
p.000715: skin diseases;
p.000715: (3) research on the refinement, development, and evalua- tion of technological devices that will replace or be a
p.000715: substitute for damaged bone, muscle, and joints and other supporting structures;
p.000715: (4) the establishment of mechanisms to monitor the causes of athletic injuries and identify ways of preventing
p.000715: such inju- ries on scholastic athletic fields; and
p.000715: (5) research into the causes of arthritis affecting children and the development, trial, and evaluation of
p.000715: techniques, drugs and devices used in the diagnosis, treatment (including med- ical rehabilitation), and
p.000715: prevention of arthritis in children.
p.000715: (c) The Director of the Institute shall carry out the national ar- thritis and musculoskeletal and skin diseases
p.000715: program in accord- ance with the plan prepared under subsection (a) and any revisions of such plan made under such
p.000715: subsection.
p.000715: RESEARCH AND TRAINING
p.000715: SEC. 437. ø285d–2¿ The Director of the Institute shall—
p.000715: (1) carry out programs of support for research and training (other than training for which National
p.000715: Research Service Awards 25 may be made under section 487) in the diagnosis, prevention, and treatment of
p.000715: arthritis and musculoskeletal and skin diseases, including support for training in medical schools, graduate clinical
p.000715: training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary re-
p.000715: search programs; and
p.000715: (2) establish programs of evaluation, planning, and dis- semination of knowledge related to such research and
p.000715: training.
p.000715: DATA SYSTEM AND INFORMATION CLEARINGHOUSE
p.000715: SEC. 438. ø285d–3¿ (a) The Director of the Institute shall es- tablish the National Arthritis and
p.000715: Musculoskeletal and Skin Dis- eases Data System for the collection, storage, analysis, retrieval, and
p.000715: dissemination of data derived from patient populations with arthritis and musculoskeletal and skin
p.000715: diseases, including where possible, data involving general populations for the purpose of de- tection of
p.000715: individuals with a risk of developing arthritis and mus- culoskeletal and skin diseases.
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p.000719: provide care for patients with arthritis and musculo- skeletal diseases; and
p.000719: (D) programs for the dissemination to the general pub- lic of information—
p.000719: (i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treat- ment, and
p.000719: of following an appropriate regimen; and
p.000719: (ii) to discourage the promotion and use of unap- proved and ineffective diagnostic, preventive, treat-
p.000719: ment, and control methods and unapproved and inef- fective drugs and devices.
p.000719: A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000719: enrolled in training programs de- scribed in paragraph (2)(B).
p.000719: (c) Each center assisted under this section may conduct pro- grams to—
p.000719: (1) establish the effectiveness of new and improved meth- ods of detection, referral, and diagnosis of
p.000719: individuals with a risk of developing arthritis and musculoskeletal diseases;
p.000719: (2) disseminate the results of research, screening, and other activities, and develop means of
p.000719: standardizing patient data and recordkeeping; and
p.000719: (3) develop community consultative services to facilitate the referral of patients to centers for treatment.
p.000719: (d) The Director of the Institute shall, insofar as practicable, provide for an equitable geographical
p.000719: distribution of centers as- sisted under this section. The Director shall give appropriate con- sideration
p.000719: to the need for centers especially suited to meeting the needs of children affected by arthritis and
p.000719: musculoskeletal dis- eases.
p.000719: (e) Support of a center under this section may be for a period of not to exceed five years. Such period may
p.000719: be extended by the Di- rector of the Institute for one or more additional periods of not more than five
p.000719: years if the operations of such center have been re- viewed by an appropriate technical and scientific peer review
p.000719: group established by the Director and if such group has recommended to the Director that such period should be
p.000719: extended.
p.000719: (f) Not later than October 1, 1993, the Director shall establish a multipurpose arthritis and musculoskeletal disease
p.000719: center for the purpose of expanding the level of research into the cause, diag- nosis, early detection,
p.000719: prevention, control, and treatment of, and re- habilitation of children with arthritis and musculoskeletal diseases.
p.000719:
p.000719:
p.000719: January 30, 2020 As Amended Through P.L. 116-94,
p.000719: Enacted December 20, 2019
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p.000719: Sec. 441A PUBLIC HEALTH SERVICE ACT 720
p.000719:
p.000719: LUPUS
p.000719: SEC. 441A. ø285d–6a¿ (a) IN GENERAL.—The Director of the Institute shall expand and intensify research and
p.000719: related activities of the Institute with respect to lupus.
p.000719: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000719: the Director under subsection (a) with similar activities conducted by the other na- tional research
p.000719: institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000719: respon- sibilities that are related to lupus.
p.000719: (c) PROGRAMS FOR LUPUS.—In carrying out subsection (a), the Director of the Institute shall conduct or
p.000719: support research to ex- pand the understanding of the causes of, and to find a cure for, lupus.
p.000719: Activities under such subsection shall include conducting and supporting the following:
p.000719: (1) Research to determine the reasons underlying the ele- vated prevalence of lupus in women, including
p.000719: African-Amer- ican women.
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p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
p.000719:
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p.000719:
p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
p.000719: members who are parents of children with arthritis.
p.000719: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in health
p.000719: education, nurs- ing, data systems, public information, or community program development.
p.000719: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000719:
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p.000721: 721
p.000721: PUBLIC HEALTH SERVICE ACT
p.000721: Sec. 442
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p.000721: January 30, 2020
p.000721: (2) The following shall be ex officio members of the Advi- sory Board:
p.000721: (A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and
p.000721: Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the
p.000721: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
...

p.000729: SEC. 447C. ø285f–4¿ MICROBICIDE RESEARCH AND DEVELOPMENT.
p.000729: The Director of the Institute, acting through the head of the Division of AIDS, shall, consistent with
p.000729: the peer-review process of the National Institutes of Health, carry out research on, and devel- opment of, safe and
p.000729: effective methods for use by women to prevent the transmission of the human immunodeficiency virus, which may include
p.000729: microbicides.
p.000729: Subpart 7—Eunice Kennedy Shriver National Institute of Child Health and Human Development 31
p.000729: PURPOSE OF THE INSTITUTE
p.000729: SEC. 448. ø285g¿ The general purpose of the National Institute of Child Health and Human Development 32 (hereafter in
p.000729: this sub- part referred to as the ‘‘Institute’’) is the conduct and support of re- search, training, health
p.000729: information dissemination, and other pro- grams with respect to gynecologic health, maternal health, child
p.000729: health, intellectual disabilities, human growth and development,
p.000729:
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p.000729: January 30, 2020
p.000729: 31 Section 1004 of Public Law 106–310 (114 Stat. 1130) authorizes the Director of the Institute to conduct a national
p.000729: longitudinal study of environmental influences (including physical, chem- ical, biological, and psychosocial) on
p.000729: children’s health and development. Subsection (d) of such section requires periodic reports to the Congress
p.000729: regarding the study. The first report is required to be submitted not later than three years after the date
p.000729: of the enactment of the Public Law, which was enacted October 17, 2000.
p.000729: 32 The probable intent of the Congress is to refer to the ‘‘Eunice Kennedy Shriver National Institute of
p.000729: Child Health and Human Development’’. Section 1(b)(7) of Public Law 110–154 (121 Stat 1827) struck the term
p.000729: ‘‘National Institute of Child Health and Human Development’’ and inserted ‘‘Eunice Kennedy Shriver National
p.000729: Institute of Child Health and Human Development’’ each place such term appeared in the heading of subpart 7 of part C
p.000729: of title IV, but not in the text of section 448.
p.000729: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000729: Sec. 449 PUBLIC HEALTH SERVICE ACT 730
p.000729:
p.000729: including prenatal development, population research, and special health problems and requirements of mothers and
p.000729: children.
p.000729: SUDDEN INFANT DEATH SYNDROME
p.000729: SEC. 449. ø285g–1¿ The Director of the Institute shall conduct and support research which specifically relates to
p.000729: sudden infant death syndrome.
p.000729: SEC. 450. ø285g–2¿ RESEARCH ON INTELLECTUAL DISABILITIES.
p.000729: The Director of the Institute shall conduct and support re- search and related activities into the causes,
p.000729: prevention, and treat- ment of intellectual disabilities.
p.000729: ASSOCIATE DIRECTOR FOR PREVENTION
p.000729: SEC. 451. ø285g–3¿ There shall be in the Institute an Associate Director for Prevention to coordinate and promote the
p.000729: programs in the Institute concerning the prevention of health problems of moth- ers and children. The Associate
p.000729: Director shall be appointed by the Director of the Institute from individuals who because of their pro- fessional
p.000729: training or experience are experts in public health or pre- ventive medicine.
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p.000729: January 30, 2020
p.000729: NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH
p.000729: SEC. 452. ø285g–4¿ (a) There shall be in the Institute an agen- cy to be known as the National Center for
p.000729: Medical Rehabilitation Research (hereafter in this section referred to as the ‘‘Center’’). The Director of the
p.000729: Institute shall appoint a qualified individual to serve as Director of the Center. The Director of the
p.000729: Center shall report directly to the Director of the Institute.
p.000729: (b) The general purpose of the Center is the conduct, support, and coordination of research and research
p.000729: training (including re- search on the development of orthotic and prosthetic devices), the dissemination
p.000729: of health information, and other programs with re- spect to the rehabilitation of individuals with
p.000729: physical disabilities resulting from diseases or disorders of the neurological, musculo- skeletal,
p.000729: cardiovascular, pulmonary, or any other physiological sys- tem (hereafter in this section referred to as
p.000729: ‘‘medical rehabilita- tion’’).
p.000729: (c)(1) In carrying out the purpose described in subsection (b), the Director of the Center may—
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p.000733: (d) The Director of the Institute shall, as appropriate, provide for the coordination of information
p.000733: among the centers assisted under this section.
p.000733: (e) Each center assisted under subsection (a) shall use the fa- cilities of a single institution, or be
p.000733: formed from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000733: Director of the Institute.
p.000733: (f) Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be
p.000733: extended for one or more additional periods not exceeding 5 years if the operations of such center have
p.000733: been reviewed by an appropriate technical and scientific peer review group established by the Director and if
p.000733: such group has recommended to the Director that such period should be extended.
p.000733:
p.000733: PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
p.000733: SEC. 452B. ø285g–6¿ The Director of the Institute shall estab- lish and maintain within the Institute an
p.000733: intramural laboratory and clinical research program in obstetrics and gynecology.
p.000733: CHILD HEALTH RESEARCH CENTERS
p.000733: SEC. 452C. ø285g–7¿ The Director of the Institute shall de- velop and support centers for conducting
p.000733: research with respect to child health. Such centers shall give priority to the expeditious transfer of
p.000733: advances from basic science to clinical applications and improving the care of infants and children.
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p.000733: January 30, 2020
p.000733:
p.000733: PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH
p.000733: SEC. 452D. ø285g–8¿ (a) IN GENERAL.—Not later than October 1, 1993, the Director of the Institute shall
p.000733: commence a study for the purpose of providing information on the general health and well-being of
p.000733: adolescents in the United States, including, with re- spect to such adolescents, information on—
p.000733: (1) the behaviors that promote health and the behaviors that are detrimental to health; and
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
p.000735: monitor the sub- jects throughout the period of the study to determine the health status of the
p.000735: subjects and any change in such status over time.
p.000735: (2) POPULATION-SPECIFIC ANALYSES.—The study required in subsection (a) shall be conducted with respect to
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p.000735: Sec. 452G PUBLIC HEALTH SERVICE ACT 736
p.000735:
p.000735: duct and support basic and biomedical research into the detec- tion and treatment of fragile X.
p.000735: (4) COORDINATION AMONG CENTERS.—The Director of the Institute shall, as appropriate, provide for the
p.000735: coordination of the activities of the centers assisted under this section, includ- ing providing for the exchange
p.000735: of information among the cen- ters.
p.000735: (5) CERTAIN ADMINISTRATIVE REQUIREMENTS.—Each center assisted under paragraph (1) shall use the facilities of a
p.000735: single institution, or be formed from a consortium of cooperating in- stitutions, meeting such requirements as
p.000735: may be prescribed by the Director of the Institute.
p.000735: (6) DURATION OF SUPPORT.—Support may be provided to a center under paragraph (1) for a period not exceeding 5 years.
p.000735: Such period may be extended for one or more additional peri- ods, each of which may not exceed 5
p.000735: years, if the operations of such center have been reviewed by an appropriate technical and scientific peer review
p.000735: group established by the Director and if such group has recommended to the Director that such period be
p.000735: extended.
p.000735: INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS
p.000735: SEC. 452G. 35 ø285g–10¿ In order to ensure the future supply of researchers dedicated to the care and research
p.000735: needs of children, the Director of the Institute, after consultation with the Adminis- trator of the Health
p.000735: Resources and Services Administration, shall support activities to provide for—
p.000735: (1) an increase in the number and size of institutional training grants to institutions supporting
p.000735: pediatric training; and
p.000735: (2) an increase in the number of career development awards for health professionals who intend to build
p.000735: careers in pediatric basic and clinical research, including pediatric phar- macological research.
p.000735: Subpart 8—National Institute of Dental Research 36
p.000735: PURPOSE OF THE INSTITUTE
p.000735: SEC. 453. ø285h¿ The general purpose of the National Institute of Dental Research 36 is the conduct and support of
p.000735: research, train- ing, health information dissemination, and other programs with re- spect to the cause, prevention, and
p.000735: methods of diagnosis and treat- ment of dental and oral diseases and conditions.
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p.000735: 35 So in law. Probably should be ‘‘SEC. 452F.’’. See amendments made by sections 201 and 1002 of Public
p.000735: Law 106–310 (114 Stat. 1109, 1128). (In amending this subpart to add section 452G above, such section
p.000735: 1002 made a reference to this subpart ‘‘as amended by section 921’’ of Public Law 106–310, but no section
p.000735: 921 appeared in the Public Law.)
p.000735: 36 See footnote for section 401(b)(1)(H).
p.000735: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000741: prompt treatment, rehabilitation, and of following an ap- propriate regimen; and
p.000741: (B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect
p.000741: dis- orders of hearing or other communication processes.
p.000741: (d) A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000741: enrolled in training pro- grams described in subsection (c)(2).
p.000741: (e) Each center assisted under this section may conduct pro- grams—
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p.000741: (1) to establish the effectiveness of new and improved methods of detection, referral, and diagnosis of
p.000741: individuals at risk of developing disorders of hearing or other communication processes; and
p.000741: (2) to disseminate the results of research, screening, and other activities, and develop means of
p.000741: standardizing patient data and recordkeeping.
p.000741: (f) The Director of the Institute shall, to the extent practicable, provide for an equitable geographical
p.000741: distribution of centers as- sisted under this section. The Director shall give appropriate con- sideration
p.000741: to the need for centers especially suited to meeting the needs of the elderly, and of children
p.000741: (particularly with respect to their education and training), affected by disorders of hearing or other
p.000741: communication processes.
p.000741: (g) Support of a center under this section may be for a period not to exceed seven years. Such period may
p.000741: be extended by the Di- rector of the Institute for one or more additional periods of not more than five
p.000741: years if the operations of such center have been re- viewed by an appropriate technical and scientific peer review
p.000741: group established by the Director, with the advice of the Institute’s advi-
p.000741: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000743: 743
p.000743: PUBLIC HEALTH SERVICE ACT
p.000743: Sec. 464D
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p.000743: sory council, if such group has recommended to the Director that such period should be extended.
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p.000753: Sec. 464U PUBLIC HEALTH SERVICE ACT 754
p.000753:
p.000753: Mental Health Research (hereafter in this section referred to as the ‘‘Office’’). The Office shall be headed by a
p.000753: director, who shall be ap- pointed by the Director of such Institute from among individuals experienced or
p.000753: knowledgeable in the provision of mental health services in rural areas. The Secretary shall carry out
p.000753: the authori- ties established in this section acting through the Director of the Office.
p.000753: (b) COORDINATION OF ACTIVITIES.—The Director of the Office, in consultation with the Director of
p.000753: the Institute and with the Di- rector of the Office of Rural Health Policy, shall—
p.000753: (1) coordinate the research activities of the Department of Health and Human Services as such activities relate
p.000753: to the mental health of residents of rural areas; and
p.000753: (2) coordinate the activities of the Office with similar ac- tivities of public and nonprofit private
p.000753: entities.
p.000753: (c) RESEARCH, DEMONSTRATIONS, EVALUATIONS, AND DISSEMI- NATION.—The Director of the Office may, with respect to
p.000753: the men- tal health of adults and children residing in rural areas—
p.000753: (1) conduct research on conditions that are unique to the residents of rural areas, or more serious or
p.000753: prevalent in such residents;
p.000753: (2) conduct research on improving the delivery of services in such areas; and
p.000753: (3) disseminate information to appropriate public and non- profit private entities.
p.000753: (d) AUTHORITY REGARDING GRANTS AND CONTRACTS.—The Di- rector of the Office may carry out the authorities
p.000753: established in subsection (c) directly and through grants, cooperative agreements, or contracts with public or
p.000753: nonprofit private entities.
p.000753: OFFICE ON AIDS
p.000753: SEC. 464U. ø285p–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000753: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000753: with respect to AIDS research related to—
p.000753: (1) primary prevention of the spread of HIV, including transmission via sexual behavior;
p.000753: (2) mental health services research; and
p.000753: (3) other matters determined appropriate by the Director.
p.000753: Subpart 17—National Institute of Nursing Research
p.000753: PURPOSE OF THE INSTITUTE
p.000753: SEC. 464V. ø285q¿ The general purpose of the National Insti- tute of Nursing Research (in this subpart referred
p.000753: to as the ‘‘Insti- tute’’) is the conduct and support of, and dissemination of informa- tion respecting, basic and
p.000753: clinical nursing research, training, and other programs in patient care research.
p.000753:
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p.000753:
p.000753: January 30, 2020
p.000753: SPECIFIC AUTHORITIES
...

p.000815: health out- comes;
p.000815: (3) the translation of basic scientific research into im- proved practice; and
p.000815: (4) the development of timely and efficient delivery of health services.
p.000815: (b) PEDIATRIC EMERGENCY MEDICAL RESEARCH.—The Secretary shall support Federal programs administered by the National
p.000815: Insti- tutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services
p.000815: Administration, the Centers for Disease Control and Prevention, and other agencies to coordinate and expand
p.000815: research in pediatric emergency medical care systems and pediatric emergency medicine, including—
p.000815: (1) an examination of the gaps and opportunities in pedi- atric emergency care research and a strategy
p.000815: for the optimal organization and funding of such research;
p.000815: (2) the role of pediatric emergency services as an inte- grated component of the overall health system;
p.000815: (3) system-wide pediatric emergency care planning, pre- paredness, coordination, and funding;
p.000815: (4) pediatric training in professional education; and
p.000815: (5) research in pediatric emergency care, specifically on the efficacy, safety, and health outcomes of
p.000815: medications used for infants, children, and adolescents in emergency care settings in order to improve patient
p.000815: safety.
p.000815: (c) IMPACT RESEARCH.—The Secretary shall support research to determine the estimated economic impact of, and
p.000815: savings that re- sult from, the implementation of coordinated emergency care sys- tems.
p.000815: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000815: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000815:
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p.000815: Sec. 498E PUBLIC HEALTH SERVICE ACT 816
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p.000815: January 30, 2020
p.000815:
p.000815: SEC. 498E. ø289g–5¿ PRECISION MEDICINE INITIATIVE.
...

p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000833:
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p.000833:
p.000833: January 30, 2020
p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833:
p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000833: priate, for individuals with a mental or substance use dis- order;
p.000833: (D) identify opportunities to collaborate with the Health Resources and Services Administration to
p.000833: develop or improve—
p.000833: (i) initiatives to encourage individuals to pursue careers (especially in rural and underserved areas and with
p.000833: rural and underserved populations) as psychia- trists, including child and adolescent psychiatrists,
p.000833: psychologists, psychiatric nurse practitioners, physi- cian assistants, clinical social workers, certified
p.000833: peer support specialists, licensed professional counselors, or other licensed or certified mental health or
p.000833: substance use disorder professionals, including such profes- sionals specializing in the diagnosis,
p.000833: evaluation, or treatment of adults with a serious mental illness or children with a serious emotional
p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
p.000833: adults with a se- rious mental illness and children with a serious emotional disturbance, and for individuals with
p.000833: a substance use dis- order.
p.000833: (m) BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.—Not later than September 30, 2020,
p.000833: and every 2 years thereafter, the Assistant Secretary shall prepare and submit to the Committee on Energy and Commerce
p.000833: and the Committee on Appro- priations of the House of Representatives and the Committee on Health, Education,
p.000833: Labor, and Pensions and the Committee on Ap- propriations of the Senate, and post on the Internet website of the
p.000833: Administration, a report containing at a minimum—
p.000833: (1) a review of activities conducted or supported by the Ad- ministration, including progress toward strategic
p.000833: priorities, goals, and objectives identified in the strategic plan developed under subsection (l);
p.000833: (2) an assessment of programs and activities carried out by the Assistant Secretary, including the extent to
p.000833: which pro- grams and activities under this title and part B of title XIX meet identified goals and
p.000833: performance measures developed for the respective programs and activities;
p.000833: (3) a description of the progress made in addressing gaps in mental and substance use disorders
p.000833: prevention, treatment, and recovery services and improving outcomes by the Adminis-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
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p.000837: January 30, 2020
p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
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p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
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p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
p.000841: (1) a summary of the manner in which individuals with co- occurring disorders are receiving treatment, including the
p.000841: most up-to-date information available regarding the number of chil- dren and adults with co-occurring mental illness
p.000841: and substance abuse disorders and the manner in which funds provided under sections 1911 and 1921 are
p.000841: being utilized, including the number of such children and adults served with such funds;
p.000841: (2) a summary of improvements necessary to ensure that individuals with co-occurring mental illness
p.000841: and substance abuse disorders receive the services they need;
p.000841: (3) a summary of practices for preventing substance abuse among individuals who have a mental illness and are
p.000841: at risk of having or acquiring a substance abuse disorder; and
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000843: PUBLIC HEALTH SERVICE ACT
p.000843: Sec. 505
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p.000843: (4) a summary of evidenced-based practices for treating in- dividuals with co-occurring mental illness and substance
p.000843: abuse disorders and recommendations for implementing such prac- tices.
p.000843: (c) FUNDS FOR REPORT.—The Secretary may obligate funds to carry out this section with such appropriations as
p.000843: are available.
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p.000847: the Senate, a report describing the services provided pursuant to this section.
p.000847: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000847: $15,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 and 2003.
p.000847: PART B—CENTERS AND PROGRAMS
p.000847: Subpart 1—Center for Substance Abuse Treatment
p.000847: CENTER FOR SUBSTANCE ABUSE TREATMENT 6
p.000847: SEC. 507. ø290bb¿ (a) ESTABLISHMENT.—There is established in the Administration a Center for Substance
p.000847: Abuse Treatment (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000847: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000847: individ- uals with extensive experience or academic qualifications in the treatment of substance use
p.000847: disorders or in the evaluation of sub- stance use disorder treatment systems.
p.000847: (b) DUTIES.—The Director of the Center shall—
p.000847: (1) administer the substance use disorder treatment block grant program authorized in section 1921;
p.000847: (2) ensure that emphasis is placed on children and adoles- cents in the development of treatment programs;
p.000847: (3) collaborate with the Attorney General to develop pro- grams to provide substance use disorder
p.000847: treatment services to individuals who have had contact with the Justice system, es- pecially adolescents;
p.000847: (4) collaborate with the Director of the Center for Sub- stance Abuse Prevention in order to provide
p.000847: outreach services to identify individuals in need of treatment services, with em-
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p.000847: January 30, 2020
p.000847: 6 Section 4 of Public Law 108–358 (118 Stat. 1664) authorizes the Secretary of Health and Human Services
p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
p.000849: consultation with the women, prepare an individualized plan for the provi- sion of services for the woman and
p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
p.000849: (A) individual, group, and family counseling, as appro- priate, regarding substance use disorders; and
p.000849: (B) follow-up services to assist the woman in pre- venting a relapse into such a disorder.
p.000849: (d) REQUIRED SUPPLEMENTAL SERVICES.—In the case of an eli- gible woman, the services referred to in subsection (a)(3)
p.000849: are as fol- lows:
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p.000849: (1) Prenatal and postpartum health care.
p.000849: (2) Referrals for necessary hospital services.
p.000849: (3) For the infants and children of the woman—
p.000849: (A) pediatric health care, including treatment for any perinatal effects of a maternal substance use disorder
p.000849: and including screenings regarding the physical and mental de- velopment of the infants and children;
p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
p.000849: (A) the applicant has the capacity to carry out a pro- gram described in subsection (a);
p.000849: (B) the plans of the applicant for such a program are consistent with the policies of such agency
p.000849: regarding the treatment of substance use disorders; and
p.000849: (C) the applicant, or any entity through which the ap- plicant will provide authorized services, meets all applica- ble
p.000849: State licensure or certification requirements regarding the provision of the services involved.
p.000849: (2) STATUS AS MEDICAID PROVIDER.—
p.000849: (A) IN GENERAL.—Subject to subparagraphs (B) and (C), the Director may make an award under subsection (a) only
p.000849: if, in the case of any authorized service that is avail- able pursuant to the State plan approved under title
p.000849: XIX of the Social Security Act for the State involved—
p.000849: (i) the applicant for the award will provide the service directly, and the applicant has entered into a
p.000849: participation agreement under the State plan and is qualified to receive payments under such plan; or
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: January 30, 2020
p.000857: 7 Sections 510 through 512 were repealed by section 3301(c) of Public Law 106–310 (114 Stat.
p.000857: 1209).
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: Sec. 514 PUBLIC HEALTH SERVICE ACT 858
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p.000857: (c) RESERVATION OF SPACE.—Prior to notifying States of the availability of space at military facilities
p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000859: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
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p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
p.000865: foundations, and alcohol bev- erage industry trade associations and companies.
p.000865: (F) ANNUAL REPORT.—
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p.000871:
p.000871: (B) CERTAIN MATTERS.—The Secretary shall carry out activities toward the following objectives with respect
p.000871: to underage drinking:
p.000871: (i) Obtaining new epidemiological data within the national or targeted surveys that identify alcohol use
p.000871: and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a
p.000871: result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol
p.000871: exposure.
p.000871: (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
p.000871: paragraph (2) by—
p.000871: (A) providing training to health care providers;
p.000871: (B) disseminating best practices, including culturally and linguistically appropriate best practices, as
p.000871: appro- priate, and developing and distributing materials; and
p.000871: (C) supporting other activities, as determined appro- priate by the Assistant Secretary.
p.000871: (4) APPLICATION.—To be eligible to receive a grant under this subsection, an entity shall submit an
p.000871: application to the Assistant Secretary at such time, and in such manner, and ac- companied by such information as the
p.000871: Assistant Secretary may require. Each application shall include—
p.000871: (A) a description of the entity;
p.000871: (B) a description of activities to be completed;
p.000871:
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p.000871: January 30, 2020
p.000871: 8 Missing period so in law. Section 9016(4) of Public Law 114-255 amends subsection (f)(2) by striking ‘‘$6,000,000 for
p.000871: fiscal year 2007’’ and all that follows through the period at the end and inserting ‘‘$3,000,000 for each of the fiscal
p.000871: years 2018 through 2022’’.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000873: 873
p.000873: PUBLIC HEALTH SERVICE ACT
p.000873: Sec. 519D
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p.000873: (C) a description of how the services specified in para- graphs (2) and (3) will be carried out and the qualifications
p.000873: for providing such services; and
p.000873: (D) a timeline for the completion of such activities.
p.000873: (5) DEFINITIONS.—For the purpose of this subsection:
p.000873: (A) BRIEF INTERVENTION.—The term ‘‘brief interven- tion’’ means, after screening a patient, providing the
p.000873: pa- tient with brief advice and other brief motivational en- hancement techniques designed to increase the
p.000873: insight of the patient regarding the patient’s alcohol use, and any re- alized or potential consequences of such
p.000873: use, to effect the desired related behavioral change.
p.000873: (B) CHILDREN AND ADOLESCENTS.—The term ‘‘children and adolescents’’ means any person under 21 years of age.
p.000873: (C) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an entity consisting of pediatric health care
p.000873: pro- viders and that is qualified to support or provide the ac- tivities identified in paragraph (2).
p.000873: (D) PEDIATRIC HEALTH CARE PROVIDER.—The term ‘‘pe- diatric health care provider’’ means a provider of
p.000873: primary health care to individuals under the age of 21 years.
p.000873: (E) SCREENING.—The term ‘‘screening’’ means using validated patient interview techniques to identify and
p.000873: as- sess the existence and extent of alcohol use in a patient.
p.000873: øSection 519C was repealed by section 9017 of Public Law 114–255.¿
p.000873: SEC. 519D. ø290bb–25d¿ CENTERS OF EXCELLENCE ON SERVICES FOR INDIVIDUALS WITH FETAL ALCOHOL SYNDROME AND AL-
p.000873: COHOL-RELATED BIRTH DEFECTS AND TREATMENT FOR INDIVIDUALS WITH SUCH CONDITIONS AND THEIR FAMI- LIES.
p.000873: (a) IN GENERAL.—The Secretary shall make awards of grants, cooperative agreements, or contracts to public
p.000873: or nonprofit private entities for the purposes of establishing not more than four centers of excellence to study
p.000873: techniques for the prevention of fetal alcohol syndrome and alcohol-related birth defects and adaptations of inno-
p.000873: vative clinical interventions and service delivery improvements for the provision of comprehensive services to
p.000873: individuals with fetal al- cohol syndrome or alcohol-related birth defects and their families and for providing
p.000873: training on such conditions.
p.000873: (b) USE OF FUNDS.—An award under subsection (a) may be used to—
p.000873: (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for
p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
p.000873: (3) provide technical assistance to communities who do not have a comprehensive system of care for such
p.000873: individuals and their families;
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000873: Sec. 520 PUBLIC HEALTH SERVICE ACT 874
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p.000873: (4) train community leaders, mental health and substance abuse professionals, families, law enforcement
p.000873: personnel, judges, health professionals, persons working in financial as- sistance programs, social service
p.000873: personnel, child welfare pro- fessionals, and other service providers on the implications of fetal alcohol
p.000873: syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
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p.000875: Sec. 520
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p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
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p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
p.000883: private nonprofit organizations, political subdivisions, consortia of political subdivi- sions, consortia of
p.000883: States, or Federally recognized Indian tribes or tribal organizations to design early intervention and
p.000883: prevention strategies that will complement the State-sponsored statewide or tribal youth suicide early
p.000883: intervention and prevention strategies developed pursuant to section 520E.
p.000883: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall ensure that activities under this
p.000883: section are coordi- nated with the relevant Department of Health and Human Services agencies and suicide working
p.000883: groups.
p.000883: (c) REQUIREMENTS.—A public organization, private nonprofit organization, political subdivision, consortium of
p.000883: political subdivi- sions, consortium of States, or federally recognized Indian tribe or tribal organization
p.000883: desiring a grant, contract, or cooperative agree- ment under this section shall demonstrate that the suicide preven-
p.000883: tion program such entity proposes will—
p.000883:
p.000883:
p.000883:
p.000883:
p.000883:
p.000883:
p.000883:
p.000883: January 30, 2020
p.000883: 10 The probable intent of the Congress is that the heading be ‘‘SUICIDE PREVENTION FOR YOUTH’’. See the amendment
p.000883: described in section 3(b)(1)(A) of Public Law 108–355 (118 Stat. 1407). The amendment cannot be executed
p.000883: because the matter in the heading to be struck does not appear, as the amendatory instruction used the wrong
p.000883: font. The amendment referred to ‘‘CHILDREN AND ADOLESCENTS’’ rather than ‘‘CHILDREN AND ADOLESCENTS’’. (The
p.000883: amendment is directed to section ‘‘520E’’. Section 520E–1 above formerly was section 520E, and was redesignated by
p.000883: section 3(b)(2) of such Public Law.)
p.000883: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000883:
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p.000883:
p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
p.000883:
p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
p.000883: (B) in the case of a consortium of States, receive the sup- port of all States involved;
p.000883: (2) provide for the timely assessment, treatment, or refer- ral for mental health or substance abuse
p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
...

p.000885: (h) DISTRIBUTION OF AWARDS.—In awarding grants and cooper- ative agreements under subsection (a), the Secretary
p.000885: shall ensure that such awards are distributed among the geographical regions of the United States and between
p.000885: urban and rural settings.
p.000885: (i) EVALUATION.—A public organization, private nonprofit orga- nization, political subdivision, consortium of
p.000885: political subdivisions, consortium of States, or Federally recognized Indian tribe or tribal organization receiving a
p.000885: grant or cooperative agreement under sub- section (a) shall prepare and submit to the Secretary at the end of the
p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
p.000885:
p.000885:
p.000885:
p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000885:
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p.000885:
p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
...

p.000889: medication for opioid dependency under section 303(g)(2)(B) of the Controlled Substances Act, the
p.000889: Assistant Sec- retary—
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p.000889: January 30, 2020
p.000889: (1) shall provide an opportunity to such practitioner to have the contact information of the practitioner
p.000889: removed from the website at the request of the practitioner; and
p.000889: (2) may evaluate other methods to periodically update the information displayed on such website.
p.000889: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prevent the Assistant Secretary from
p.000889: using any unob- ligated amounts otherwise made available to the Administration to maintain the Routing Service.
p.000889: SEC. 520F. ø290bb–37¿ STRENGTHENING COMMUNITY CRISIS RE- SPONSE SYSTEMS.
p.000889: (a) IN GENERAL.—The Secretary shall award competitive grants to—
p.000889: (1) State and local governments and Indian tribes and trib- al organizations, to enhance community-based crisis
p.000889: response systems; or
p.000889: (2) States to develop, maintain, or enhance a database of beds at inpatient psychiatric facilities, crisis
p.000889: stabilization units, and residential community mental health and residential sub- stance use disorder treatment
p.000889: facilities, for adults with a seri- ous mental illness, children with a serious emotional disturb- ance, or
p.000889: individuals with a substance use disorder.
p.000889: (b) APPLICATIONS.—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000889:
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p.000889: Sec. 520F PUBLIC HEALTH SERVICE ACT 890
p.000889: (1) IN GENERAL.—To receive a grant under subsection (a), an entity shall submit to the Secretary an
p.000889: application, at such time, in such manner, and containing such information as the Secretary may require.
p.000889: (2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An applica- tion for a grant under subsection (a)(1) shall include
p.000889: a plan for—
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p.000889:
p.000889: January 30, 2020
p.000889: (A) promoting integration and coordination between local public and private entities engaged in crisis response,
p.000889: including first responders, emergency health care pro- viders, primary care providers, law enforcement,
...

p.000895: (a) DEFINITIONS.—In this section:
p.000895: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, or other appropriate State agency, in
p.000895: collaboration with 1 or more qualified community programs as described in sec- tion 1913(b)(1) or 1 or
p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
p.000895: and physical
p.000895:
p.000895:
p.000895:
p.000895:
p.000895: January 30, 2020
p.000895: 13 So in law. Words in the heading (except the first) probably should be all small caps. See section
p.000895: 3213 of Public Law 106–310 (114 Stat. 1206).
p.000895: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000895:
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p.000895: Sec. 520K PUBLIC HEALTH SERVICE ACT 896
p.000895:
p.000895: health services, which may include practices that share the same space in the same facility.
p.000895: (3) SPECIAL POPULATION.—The term ‘‘special population’’ means—
p.000895: (A) adults with a mental illness who have co-occurring physical health conditions or chronic diseases;
p.000895: (B) adults with a serious mental illness who have co- occurring physical health conditions or chronic
p.000895: diseases;
p.000895: (C) children and adolescents with a serious emotional disturbance with co-occurring physical health conditions
p.000895: or chronic diseases; or
p.000895: (D) individuals with a substance use disorder.
p.000895: (b) GRANTS AND COOPERATIVE AGREEMENTS.—
p.000895: (1) IN GENERAL.—The Secretary may award grants and co- operative agreements to eligible entities to support the
p.000895: im- provement of integrated care for primary care and behavioral health care in accordance with paragraph (2).
p.000895: (2) PURPOSES.—A grant or cooperative agreement awarded under this section shall be designed to—
p.000895: (A) promote full integration and collaboration in clin- ical practices between primary and behavioral health
p.000895: care;
p.000895: (B) support the improvement of integrated care models for primary care and behavioral health care to improve the
p.000895: overall wellness and physical health status of adults with a serious mental illness or children with a
p.000895: serious emo- tional disturbance; and
p.000895: (C) promote integrated care services related to screen- ing, diagnosis, prevention, and treatment of mental and
p.000895: substance use disorders, and co-occurring physical health conditions and chronic diseases.
p.000895: (c) APPLICATIONS.—
p.000895: (1) IN GENERAL.—An eligible entity seeking a grant or co- operative agreement under this section shall
p.000895: submit an appli- cation to the Secretary at such time, in such manner, and ac- companied by such
p.000895: information as the Secretary may require, including the contents described in paragraph (2).
p.000895: (2) CONTENTS.—The contents described in this paragraph are—
p.000895:
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p.000895: January 30, 2020
p.000895: (A) a description of a plan to achieve fully collabo- rative agreements to provide services to
p.000895: special popu- lations;
p.000895: (B) a document that summarizes the policies, if any, that serve as barriers to the provision of
p.000895: integrated care, and the specific steps, if applicable, that will be taken to address such barriers;
p.000895: (C) a description of partnerships or other arrange- ments with local health care providers to provide
p.000895: services to special populations;
p.000895: (D) an agreement and plan to report to the Secretary performance measures necessary to evaluate patient
p.000895: out- comes and facilitate evaluations across participating projects; and
p.000895: (E) a plan for sustainability beyond the grant or coop- erative agreement period under subsection (e).
...

p.000897: (f) REPORT ON PROGRAM OUTCOMES.—An eligible entity receiv- ing a grant or cooperative agreement under this section
p.000897: shall sub- mit an annual report to the Secretary that includes—
p.000897: (1) the progress made to reduce barriers to integrated care as described in the entity’s application under
p.000897: subsection (c); and
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p.000897: January 30, 2020
p.000897: (2) a description of functional outcomes of special popu- lations, including—
p.000897: (A) with respect to adults with a serious mental ill- ness, participation in supportive housing or
p.000897: independent living programs, attendance in social and rehabilitative programs, participation in job training
p.000897: opportunities, satis- factory performance in work settings, attendance at sched- uled medical and mental health
p.000897: appointments, and compli- ance with prescribed medication regimes;
p.000897: (B) with respect to individuals with co-occurring men- tal illness and physical health conditions and chronic
p.000897: dis- eases, attendance at scheduled medical and mental health appointments, compliance with prescribed medication
p.000897: re- gimes, and participation in learning opportunities related to improved health and lifestyle practices; and
p.000897: (C) with respect to children and adolescents with a se- rious emotional disturbance who have co-occurring phys-
p.000897: ical health conditions and chronic diseases, attendance at scheduled medical and mental health
p.000897: appointments, com- pliance with prescribed medication regimes, and participa- tion in learning opportunities at school
p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
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p.000897: Sec. 520L PUBLIC HEALTH SERVICE ACT 898
p.000897:
p.000897: els;
p.000897: (A) development and selection of integrated care mod-
p.000897: (B) dissemination of evidence-based interventions in
p.000897: integrated care;
p.000897: (C) establishment of organizational practices to sup- port operational and administrative success; and
p.000897: (D) other activities, as the Secretary determines ap- propriate.
p.000897: (2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA- TION.—The information and resources provided by the
...

p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
p.000917: each of fis- cal years 2019 through 2023.
p.000917: SEC. 547A. ø290ee–2a¿ PEER SUPPORT TECHNICAL ASSISTANCE CEN- TER.
p.000917: (a) ESTABLISHMENT.—The Secretary, acting through the Assist- ant Secretary, shall establish or operate a
p.000917: National Peer-Run Training and Technical Assistance Center for Addiction Recovery Support (referred to in this
p.000917: section as the ‘‘Center’’).
p.000917: (b) FUNCTIONS.—The Center established under subsection (a) shall provide technical assistance and support
p.000917: to recovery commu- nity organizations and peer support networks, including such as- sistance and support
p.000917: related to—
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000917:
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p.000929: 929
p.000929: PUBLIC HEALTH SERVICE ACT
p.000929: Sec. 561
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p.000929: January 30, 2020
p.000929: ter, evaluated by an independent program evaluator through the use of outcomes measures, as determined by the
p.000929: Secretary;
p.000929: (3) the retention rate of program participants; and
p.000929: (4) any other information that the Secretary may require for the purpose of—ensuring that the Center is
p.000929: complying with all the requirements of the grant, including providing the full continuum of services described
p.000929: in subsection (g)(1)(B).
p.000929: (i) PRIVACY.—The provisions of this section, including with re- spect to data reporting and program
p.000929: oversight, shall be subject to all applicable Federal and State privacy laws.
p.000929: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $10,000,000 for each of fiscal
p.000929: years 2019 through 2023 for purposes of carrying out this section.
p.000929: PART E—CHILDREN WITH SERIOUS EMOTIONAL DISTURBANCES
p.000929: SEC. 561. ø290ff¿ COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CHILDREN WITH SERIOUS
p.000929: EMOTIONAL DISTURBANCES.
p.000929: (a) GRANTS TO CERTAIN PUBLIC ENTITIES.—
p.000929: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Center for Mental Health Services,
p.000929: shall make grants to public entities for the purpose of providing com- prehensive community mental health
p.000929: services to children with a serious emotional disturbance, which may include efforts to identify and serve
p.000929: children at risk.
p.000929: (2) DEFINITION OF PUBLIC ENTITY.—For purposes of this part, the term ‘‘public entity’’ means any
p.000929: State, any political subdivision of a State, and any Indian tribe or tribal organiza- tion (as defined in section
p.000929: 4(b) and section 4(c) of the Indian Self-Determination and Education Assistance Act).
p.000929: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000929: (1) REQUIREMENT OF STATUS AS GRANTEE UNDER PART B OF TITLE XIX.—The Secretary may make a grant under
p.000929: subsection
p.000929: (a) to a public entity only if—
p.000929: (A) in the case of a public entity that is a State, the State is such a grantee under section 1911;
p.000929: (B) in the case of a public entity that is a political sub- division of a State, the State in which the political
p.000929: subdivi- sion is located is such a grantee; and
p.000929: (C) in the case of a public entity that is an Indian tribe or tribal organization, the State in which the
p.000929: tribe or tribal organization is located is such a grantee.
p.000929: (2) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000929: (A) Subject to subparagraph (B), the Secretary may make a grant under subsection (a) only if, in the
p.000929: case of any service under such subsection that is covered in the State plan approved under title XIX of the
p.000929: Social Security Act for the State involved—
p.000929: (i) the public entity involved will provide the serv- ice directly, and the entity has entered into a partici-
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p.000931: January 30, 2020
p.000931: (A) Non-Federal contributions required in paragraph
p.000931: (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts
p.000931: provided by the Federal Government, or services assisted or subsidized to any significant extent by the
p.000931: Federal Government, may not be included in determining the amount of such non- Federal contributions.
p.000931: (B) In making a determination of the amount of non- Federal contributions for purposes of subparagraph
p.000931: (A), the Secretary may include only non-Federal contributions in excess of the average amount of
p.000931: non-Federal contribu- tions made by the public entity involved toward the pur- pose described in
p.000931: subsection (a) for the 2-year period pre- ceding the first fiscal year for which the entity receives a
p.000931: grant under such section.
p.000931: SEC. 562. ø290ff–1¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.000931: (a) SYSTEMS OF COMPREHENSIVE CARE.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that, with respect to children
p.000931: with a serious emotional disturbance, the public entity involved will carry out the purpose described in such section
p.000931: only through establishing and operating 1 or more systems of care for making each of the mental health services
p.000931: specified in subsection (c) available to each child provided access to the system. In providing for such a system,
p.000931: the public entity may make grants to, and enter into contracts with, public and nonprofit private entities.
p.000931: (2) STRUCTURE OF SYSTEM.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000931: para- graph (1) will—
p.000931: (A) be established in a community selected by the pub- lic entity involved;
p.000931: (B) consist of such public agencies and nonprofit pri- vate entities in the community as are necessary to
p.000931: ensure that each of the services specified in subsection (c) is avail- able to each child provided access to the
p.000931: system;
p.000931: (C) be established pursuant to agreements that the public entity enters into with the agencies and entities de-
p.000931: scribed in subparagraph (B);
p.000931: (D) coordinate the provision of the services of the sys- tem; and
p.000931: (E) establish an office whose functions are to serve as the location through which children are provided access to the
p.000931: system, to coordinate the provision of services of the system, and to provide information to the public
p.000931: regarding the system.
p.000931: (3) COLLABORATION OF LOCAL PUBLIC ENTITIES.—A funding agreement for a grant under section 561(a) is that,
p.000931: for pur- poses of the establishment and operation of a system of care under paragraph (1), the public
p.000931: entity involved will seek col- laboration among all public agencies that provide human serv- ices in the
p.000931: community in which the system is established, in- cluding but not limited to those providing mental
p.000931: health serv-
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000931:
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p.000931:
p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: January 30, 2020
p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
p.000931: provider involved to each child provided access to the system; and
p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
p.000931: (2) SPECIFICATION OF NON-MENTAL HEALTH SERVICES.—The providers referred to in paragraph (1) are providers of
p.000931: medical services other than mental health services, providers of edu- cational services, providers of
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p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
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p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
p.000933: (B) with respect to subparagraph (D) of such para- graph, to authorize the system of care to expend the grant
p.000933: under section 561(a) (or the non-Federal contributions made with respect to the grant) to provide
p.000933: legal services or any service with respect to which expenditures regard- ing the grant are prohibited under
p.000933: subsection (d)(1)(B).
p.000933: (f) RESTRICTIONS ON USE OF GRANT.—A funding agreement for a grant under section 561(a) is that the grant, and
p.000933: the non-Federal contributions made with respect to the grant, will not be ex- pended—
p.000933: (1) to purchase or improve real property (including the construction or renovation of facilities);
p.000933: (2) to provide for room and board in residential programs serving 10 or fewer children;
p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
...

p.000935: the multidisciplinary team required in sub- section (b) will—
p.000935: (1) in developing, carrying out, reviewing, and revising the plan consider any individualized education program
p.000935: in effect for the child pursuant to part B of the Individuals with Dis- abilities Education Act;
p.000935: (2) ensure that the plan is consistent with such individual- ized education program and provides for coordinating
p.000935: services under the plan with services under such program; and
p.000935: (3) ensure that the memorandum of understanding entered into under section 562(d)(3)(B) regarding such Act
p.000935: includes provisions regarding compliance with this subsection.
p.000935: (d) CONTENTS OF PLAN.—A funding agreement for a grant under section 561(a) is that the plan required in
p.000935: subsection (a) for a child will—
p.000935: (1) identify and state the needs of the child for the services available pursuant to section 562 through the system;
p.000935: (2) provide for each of such services that is appropriate to the circumstances of the child, including, except in the
p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
p.000935: day treat- ment under paragraph (5) of such section, and foster care or group homes under paragraph (7)
p.000935: of such section; and
p.000935: (C) the development of individualized plans for pur- poses of section 563;
p.000935:
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p.000935: January 30, 2020
p.000935: 16 So in law. See section 119 of Public Law 102–321 (106 Stat. 349). Probably should be a pe- riod.
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000935: Sec. 564 PUBLIC HEALTH SERVICE ACT 936
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p.000935: (3) recreational activities for children provided access to the system; and
p.000935: (4) such other services as may be appropriate in providing for the comprehensive needs with respect to mental
p.000935: health of children with a serious emotional disturbance.
p.000935: (b) COMPREHENSIVE PLAN.—The Secretary may make a grant under section 561(a) only if, with respect to the
p.000935: jurisdiction of the public entity involved, the entity has submitted to the Secretary, and has had approved
p.000935: by the Secretary, a plan for the development of a jurisdiction-wide system of care for community-based services
p.000935: for children with a serious emotional disturbance that specifies the progress the public entity has made in developing
p.000935: the jurisdiction- wide system, the extent of cooperation across agencies serving chil- dren in the establishment of the
p.000935: system, the Federal and non-Fed- eral resources currently committed to the establishment of the sys- tem, and the
p.000935: current gaps in community services and the manner in which the grant under section 561(a) will be
p.000935: expended to ad- dress such gaps and establish local systems of care.
p.000935: (c) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—A fund- ing agreement for a grant under section 561(a) is
p.000935: that, if a charge is imposed for the provision of services under the grant, such charge—
p.000935: (1) will be made according to a schedule of charges that is made available to the public;
p.000935: (2) will be adjusted to reflect the income of the family of the child involved; and
p.000935: (3) will not be imposed on any child whose family has in- come and resources of equal to or less than 100
p.000935: percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised
p.000935: by the Secretary in ac- cordance with section 673(2) of the Omnibus Budget Reconcili- ation Act of 1981.
p.000935: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A funding agreement for a grant under
p.000935: section 561(a) is that the grant, and the non-Federal contributions made with re- spect to the grant,
p.000935: will not be expended to make payment for any item or service to the extent that payment has been
p.000935: made, or can reasonably be expected to be made, with respect to such item or service—
p.000935: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000935: health benefits program; or
p.000935: (2) by an entity that provides health services on a prepaid basis.
p.000935: (e) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 561(a) is
p.000935: that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
p.000935: grant by the public entity involved.
p.000935: (f) REPORTS TO SECRETARY.—A funding agreement for a grant under section 561(a) is that the public entity
p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
p.000935: provided access to systems of care operated pursuant to the grant, the demographic
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: 937
p.000937: PUBLIC HEALTH SERVICE ACT
p.000937: Sec. 565
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p.000937: January 30, 2020
p.000937: characteristics of the children, the types and costs of services pro- vided pursuant to the grant, the
p.000937: availability and use of third-party reimbursements, estimates of the unmet need for such services in the
p.000937: jurisdiction of the entity, and the manner in which the grant has been expended toward the establishment of a
p.000937: jurisdiction-wide system of care for children with a serious emotional disturbance, and such other
p.000937: information as the Secretary may require with re- spect to the grant.
p.000937: (g) DESCRIPTION OF INTENDED USES OF GRANT.—The Secretary may make a grant under section 561(a) only if—
p.000937: (1) the public entity involved submits to the Secretary a description of the purposes for which the
p.000937: entity intends to ex- pend the grant;
p.000937: (2) the description identifies the populations, areas, and lo- calities in the jurisdiction of the entity with a need
p.000937: for services under this section; and
p.000937: (3) the description provides information relating to the services and activities to be provided, including
p.000937: a description of the manner in which the services and activities will be co- ordinated with any similar
p.000937: services or activities of public or nonprofit entities.
p.000937: (h) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under section 561(a) only if an
p.000937: application for the grant is submitted to the Secretary, the application contains the description of intended uses
p.000937: required in subsection (g), and the application is in such form, is made in such manner, and contains
p.000937: such agree- ments, assurances, and information as the Secretary determines to be necessary to carry out this section.
p.000937: SEC. 565. ø290ff–4¿ GENERAL PROVISIONS.
p.000937: (a) DURATION OF SUPPORT.—The period during which pay- ments are made to a public entity from a grant
p.000937: under section 561(a) may not exceed 6 fiscal years.
p.000937: (b) TECHNICAL ASSISTANCE.—
p.000937: (1) IN GENERAL.—The Secretary shall, upon the request of a public entity, regardless of whether such public
p.000937: entity is re- ceiving a grant under section 561(a)—
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p.000937: grants under section 561(a); and
p.000937: (B) provide to the entity training and technical assist- ance with respect to the planning, development, and oper-
p.000937: ation of systems of care described in section 562.
p.000937: (2) AUTHORITY FOR GRANTS AND CONTRACTS.—The Sec- retary may provide technical assistance under
p.000937: subsection (a) directly or through grants to, or contracts with, public and non- profit private entities.
p.000937: (c) EVALUATIONS AND REPORTS BY SECRETARY.—
p.000937: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities,
p.000937: provide for annual evaluations of programs carried out pursuant to section 561(a). The evaluations shall assess the
p.000937: effectiveness of the systems of care operated pursuant to such section, including longitudinal studies of
p.000937: outcomes of services provided by such systems, other
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
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p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
p.000937: first appro- priated under subsection (c), and annually thereafter, submit to the Congress a report
p.000937: summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year and making such
p.000937: recommendations for administrative and legisla- tive initiatives with respect to this section as the Secretary de-
p.000937: termines to be appropriate.
p.000937: (d) DEFINITIONS.—For purposes of this part:
p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
...

p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
p.000937:
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p.000937: January 30, 2020
p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
p.000939: SEC. 581. 19 ø290hh¿ CHILDREN AND VIOLENCE.
p.000939: (a) IN GENERAL.—The Secretary, in consultation with the Sec- retary of Education and the Attorney General, shall
p.000939: carry out di- rectly or through grants, contracts or cooperative agreements with public entities a program to assist
p.000939: local communities in developing ways to assist children in dealing with violence.
p.000939: (b) ACTIVITIES.—Under the program under subsection (a), the Secretary may—
p.000939: (1) provide financial support to enable local communities to implement programs to foster the health and
p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
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p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
p.000939: (2) the development of knowledge with regard to evidence- based practices for identifying and treating mental,
p.000939: behavioral, and biological disorders of children and youth resulting from witnessing or experiencing a
p.000939: traumatic event.
p.000939: (b) PRIORITIES.—In awarding grants, contracts or cooperative agreements under subsection (a)(2) (related to
p.000939: the development of knowledge on evidence-based practices for treating mental, behav- ioral, and biological
p.000939: disorders associated with psychological trau- ma), the Secretary shall give priority to universities,
p.000939: hospitals, mental health agencies, and other programs that have established clinical expertise and research
p.000939: experience in the field of trauma-re- lated mental disorders.
p.000939: (c) CHILD OUTCOME DATA.—The NCTSI coordinating center de- scribed in subsection (a)(1) shall collect, analyze, report,
p.000939: and make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding
p.000939: the early identification and de- livery of evidence-based treatment and services for children and families
p.000939: served by the NCTSI grantees.
p.000939: (d) TRAINING.—The NCTSI coordinating center shall facilitate the coordination of training initiatives in
p.000939: evidence-based and trau-
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000941: PUBLIC HEALTH SERVICE ACT
p.000941: Sec. 591
p.000941:
p.000941: ma-informed treatments, interventions, and practices offered to NCTSI grantees, providers, and partners.
p.000941: (e) DISSEMINATION AND COLLABORATION.—The NCTSI coordi- nating center shall, as appropriate, collaborate with—
p.000941: (1) the Secretary, in the dissemination of evidence-based and trauma-informed interventions, treatments,
p.000941: products, and other resources to appropriate stakeholders; and
p.000941: (2) appropriate agencies that conduct or fund research within the Department of Health and Human Services, for
p.000941: pur- poses of sharing NCTSI expertise, evaluation data, and other activities, as appropriate.
p.000941: (f) REVIEW.—The Secretary shall, consistent with the peer-re- view process, ensure that NCTSI applications
p.000941: are reviewed by ap- propriate experts in the field as part of a consensus-review process. The Secretary shall
p.000941: include review criteria related to expertise and experience in child trauma and evidence-based practices.
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p.000943: facilities, and other health care professionals and patients, shall promulgate regulations that require
p.000943: facilities to which the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10801 et
p.000943: seq.) applies, to meet the requirements of sub- section (b).
p.000943: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require that—
p.000943: (1) facilities described in subsection (a) ensure that there is an adequate number of qualified professional
p.000943: and supportive staff to evaluate patients, formulate written individualized, comprehensive treatment plans,
p.000943: and to provide active treat- ment measures;
p.000943: (2) appropriate training be provided for the staff of such facilities in the use of restraints and any
p.000943: alternatives to the use of restraints; and
p.000943: (3) such facilities provide complete and accurate notifica- tion of deaths, as required under section 592(a).
p.000943: (c) ENFORCEMENT.—A facility to which this part applies that fails to comply with any requirement of this part,
p.000943: including a fail- ure to provide appropriate training, shall not be eligible for partici- pation in any program
p.000943: supported in whole or in part by funds ap- propriated to any Federal department or agency.
p.000943:
p.000943: PART I—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON- MEDICAL, COMMUNITY-BASED
p.000943: FACILITIES FOR CHILDREN AND YOUTH
p.000943:
p.000943: SEC. 595. ø290jj¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN NON-MEDICAL,
p.000943: COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH.
p.000943: (a) PROTECTION OF RIGHTS.—
p.000943: (1) IN GENERAL.—A public or private non-medical, commu- nity-based facility for children and youth (as defined in
p.000943: regula- tions to be promulgated by the Secretary) that receives support
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p.000943: 21 Section 593 appears according to the probable intent of the Congress. Section 3207 of Public Law 106–310 (114 Stat.
p.000943: 1196) added sections 591 and 592, and closing quotations were provided at the end of section 592. Immediately following
p.000943: that section, however, section 593 appeared in quotations, and closing quotations were provided at the end of the
p.000943: section. The probable intent of the Congress is that closing quotations should not have been provided at
p.000943: the end of section 592.
p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000943: Sec. 595 PUBLIC HEALTH SERVICE ACT 944
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p.000943: in any form from any program supported in whole or in part with funds appropriated under this Act
p.000943: shall protect and pro- mote the rights of each resident of the facility, including the right to be free
p.000943: from physical or mental abuse, corporal punish- ment, and any restraints or involuntary seclusions imposed for purposes
p.000943: of discipline or convenience.
p.000943: (2) NONAPPLICABILITY.—Notwithstanding this part, a facil- ity that provides inpatient psychiatric treatment
p.000943: services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and (h)
p.000943: of section 1905 of the Social Secu- rity Act, shall comply with the requirements of part H.
p.000943: (3) APPLICABILITY OF MEDICAID PROVISIONS.—A non-med- ical, community-based facility for children and
p.000943: youth funded under the Medicaid program under title XIX of the Social Secu- rity Act shall continue to meet all
p.000943: existing requirements for participation in such program that are not affected by this part.
p.000943: (b) REQUIREMENTS.—
p.000943: (1) IN GENERAL.—Physical restraints and seclusion may only be imposed on a resident of a facility
p.000943: described in sub- section (a) if—
p.000943: (A) the restraints or seclusion are imposed only in emergency circumstances and only to ensure the imme-
p.000943: diate physical safety of the resident, a staff member, or others and less restrictive interventions have
p.000943: been deter- mined to be ineffective; and
p.000943: (B) the restraints or seclusion are imposed only by an individual trained and certified, by a State-recognized body (as
p.000943: defined in regulation promulgated by the Secretary) and pursuant to a process determined appropriate by
p.000943: the State and approved by the Secretary, in the prevention and use of physical restraint and seclusion,
p.000943: including the needs and behaviors of the population served, relationship building, alternatives to restraint and
p.000943: seclusion, de-esca- lation methods, avoiding power struggles, thresholds for restraints and seclusion, the
p.000943: physiological and psycho- logical impact of restraint and seclusion, monitoring phys- ical signs of distress
p.000943: and obtaining medical assistance, legal issues, position asphyxia, escape and evasion tech- niques, time
p.000943: limits, the process for obtaining approval for continued restraints, procedures to address problematic re-
p.000943: straints, documentation, processing with children, and fol- low-up with staff, and investigation of injuries and
p.000943: com- plaints.
p.000943: (2) INTERIM PROCEDURES RELATING TO TRAINING AND CER- TIFICATION.—
p.000943: (A) IN GENERAL.—Until such time as the State devel- ops a process to assure the proper training and
p.000943: certifi- cation of facility personnel in the skills and competencies referred in paragraph (1)(B), the facility
p.000943: involved shall de- velop and implement an interim procedure that meets the requirements of subparagraph (B).
p.000943: (B) REQUIREMENTS.—A procedure developed under subparagraph (A) shall—
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p.000945: PUBLIC HEALTH SERVICE ACT
p.000945: Sec. 595
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p.000945: (i) ensure that a supervisory or senior staff person with training in restraint and seclusion who is com-
p.000945: petent to conduct a face-to-face assessment (as defined in regulations promulgated by the Secretary), will as-
p.000945: sess the mental and physical well-being of the child or youth being restrained or secluded and assure that the
p.000945: restraint or seclusion is being done in a safe manner;
p.000945: (ii) ensure that the assessment required under clause (i) take place as soon as practicable, but in no
p.000945: case later than 1 hour after the initiation of the re- straint or seclusion; and
p.000945: (iii) ensure that the supervisory or senior staff person continues to monitor the situation for the dura- tion
p.000945: of the restraint and seclusion.
p.000945: (3) LIMITATIONS.—
p.000945: (A) IN GENERAL.—The use of a drug or medication that is used as a restraint to control behavior or restrict
p.000945: the resident’s freedom of movement that is not a standard treatment for the resident’s medical or
p.000945: psychiatric condi- tion in nonmedical community-based facilities for children and youth described in subsection
p.000945: (a)(1) is prohibited.
p.000945: (B) PROHIBITION.—The use of mechanical restraints in non-medical, community-based facilities for children and
p.000945: youth described in subsection (a)(1) is prohibited.
p.000945: (C) LIMITATION.—A non-medical, community-based fa- cility for children and youth described in subsection
p.000945: (a)(1) may only use seclusion when a staff member is continu- ously face-to-face monitoring the resident and
p.000945: when strong licensing or accreditation and internal controls are in place.
p.000945: (c) RULE OF CONSTRUCTION.—
p.000945: (1) IN GENERAL.—Nothing in this section shall be con- strued as prohibiting the use of restraints for
p.000945: medical immo- bilization, adaptive support, or medical protection.
p.000945: (2) CURRENT LAW.—This part shall not be construed to af- fect or impede any Federal or State law or
p.000945: regulations that provide greater protections than this part regarding seclusion and restraint.
p.000945: (d) DEFINITIONS.—In this section:
p.000945: (1) MECHANICAL RESTRAINT.—The term ‘‘mechanical re- straint’’ means the use of devices as a means of
p.000945: restricting a resident’s freedom of movement.
p.000945: (2) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000945: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000945: (3) PHYSICAL RESTRAINT.—The term ‘‘physical restraint’’ means a personal restriction that immobilizes or
p.000945: reduces the ability of an individual to move his or her arms, legs, or head freely. Such term does not include a
p.000945: physical escort.
p.000945: (4) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000945: term does not include a time out.
p.000945: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000945: Sec. 595A PUBLIC HEALTH SERVICE ACT 946
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p.000945: (5) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000945: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000945: for the purpose of calming. Time out is not seclusion.
p.000945: SEC. 595A. ø290jj–1¿ REPORTING REQUIREMENT.
p.000945: Each facility to which this part applies shall notify the appro- priate State licensing or regulatory agency, as
p.000945: determined by the Secretary—
p.000945: (1) of each death that occurs at each such facility. A notifi- cation under this section shall include the name of the
p.000945: resident and shall be provided not later than 24 hours after the time of the individuals death; and
p.000945: (2) of the use of seclusion or restraints in accordance with regulations promulgated by the Secretary, in consultation
p.000945: with the States.
p.000945: SEC. 595B. ø290jj–2¿ REGULATIONS AND ENFORCEMENT.
p.000945: (a) TRAINING.—Not later than 6 months after the date of the enactment of this part, the Secretary,
p.000945: after consultation with ap- propriate State, local, public and private protection and advocacy
p.000945: organizations, health care professionals, social workers, facilities, and patients, shall promulgate regulations
p.000945: that—
p.000945: (1) require States that license non-medical, community- based residential facilities for children and youth to
p.000945: develop li- censing rules and monitoring requirements concerning behav- ior management practice that will ensure
p.000945: compliance with Fed- eral regulations and to meet the requirements of subsection (b);
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p.000945: (2) require States to develop and implement such licensing rules and monitoring requirements within 1 year after the
p.000945: pro- mulgation of the regulations referred to in the matter pre- ceding paragraph (1); and
p.000945: (3) support the development of national guidelines and standards on the quality, quantity, orientation and
p.000945: training, required under this part, as well as the certification or licen- sure of those staff responsible
p.000945: for the implementation of behav- ioral intervention concepts and techniques.
p.000945: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require—
p.000945: (1) that facilities described in subsection (a) ensure that there is an adequate number of qualified
p.000945: professional and sup- portive staff to evaluate residents, formulate written individ- ualized, comprehensive
p.000945: treatment plans, and to provide active treatment measures;
p.000945: (2) the provision of appropriate training and certification of the staff of such facilities in the prevention and use
p.000945: of physical restraint and seclusion, including the needs and behaviors of the population served, relationship
p.000945: building, alternatives to re- straint, de-escalation methods, avoiding power struggles, thresholds for
p.000945: restraints, the physiological impact of restraint and seclusion, monitoring physical signs of distress and obtain-
p.000945: ing medical assistance, legal issues, position asphyxia, escape and evasion techniques, time limits for the use
p.000945: of restraint and
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p.000947: Sec. 581
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p.000947: seclusion, the process for obtaining approval for continued re- straints and seclusion, procedures to
p.000947: address problematic re- straints, documentation, processing with children, and follow- up with staff, and
p.000947: investigation of injuries and complaints; and
p.000947: (3) that such facilities provide complete and accurate noti- fication of deaths, as required under section 595A(1).
p.000947: (c) ENFORCEMENT.—A State to which this part applies that fails to comply with any requirement of this part,
p.000947: including a fail- ure to provide appropriate training and certification, shall not be eligible for
p.000947: participation in any program supported in whole or in part by funds appropriated under this Act.
p.000947: PART G 22—SERVICES PROVIDED THROUGH RELIGIOUS ORGANIZATIONS 23
p.000947: SEC. 581. ø290kk¿ APPLICABILITY TO DESIGNATED PROGRAMS.
p.000947: (a) DESIGNATED PROGRAMS.—Subject to subsection (b), this part applies to discretionary and formula grant
p.000947: programs adminis- tered by the Substance Abuse and Mental Health Services Admin- istration that make awards of
p.000947: financial assistance to public or pri- vate entities for the purpose of carrying out activities to prevent or treat
p.000947: substance abuse (in this part referred to as a ‘‘designated pro- gram’’). Designated programs include the program under
p.000947: subpart II of part B of title XIX (relating to formula grants to the States).
p.000947: (b) LIMITATION.—This part does not apply to any award of fi- nancial assistance under a designated program
p.000947: for a purpose other than the purpose specified in subsection (a).
p.000947: (c) DEFINITIONS.—For purposes of this part (and subject to sub- section (b)):
p.000947: (1) The term ‘‘designated program’’ has the meaning given such term in subsection (a).
p.000947: (2) The term ‘‘financial assistance’’ means a grant, coopera- tive agreement, or contract.
p.000947: (3) The term ‘‘program beneficiary’’ means an individual who receives program services.
p.000947: (4) The term ‘‘program participant’’ means a public or pri- vate entity that has received financial assistance under a
p.000947: des- ignated program.
p.000947: (5) The term ‘‘program services’’ means treatment for sub- stance abuse, or preventive services regarding such abuse,
p.000947: pro- vided pursuant to an award of financial assistance under a designated program.
p.000947: (6) The term ‘‘religious organization’’ means a nonprofit re- ligious organization.
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p.000947: 22 There are two parts G in this title. The first was added by section 3101 of Public Law 106– 310 (114 Stat. 1168) and
p.000947: relates to projects for children and violence; that part also begins with section 581. See page 669. Sections
p.000947: 3207 and 3208 of such Public Law (114 Stat. 1195, 1197) added parts H and I, respectively.
p.000947: Subsequently, part G above was added by section 144 of the Community Renewal Tax Relief Act of 2000 (as enacted
p.000947: into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A– 619), which provides that title V
p.000947: of this Act ‘‘is amended by adding at the end the following part:’’, thereby placing that part G after the
p.000947: part I added by Public Law 106–310.
p.000947: 23 Section 1955 of this Act also relates to religious organizations as providers of substance abuse
p.000947: services. That section was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
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p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
p.000951: National Center on Substance Abuse and Child Welfare.
p.000951: TITLE VI—ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000951: DECLARATION OF PURPOSE
p.000951: SEC. 600. ø291¿ The purpose of this title is—
p.000951: (a) to assist the several States in the carrying out of their programs for the construction and modernization of such
p.000951: public or other nonprofit community hospitals and other medical fa- cilities as may be necessary, in
p.000951: conjunction with existing facili-
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p.000951: January 30, 2020
p.000951: 24 Placement of section 550 is so in law. Section 8214 of Public Law 115-271 inserted a second section 550 at the end
p.000951: of title V.
p.000951: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000951:
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p.000951: Sec. 601 PUBLIC HEALTH SERVICE ACT 952
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p.001023:
p.001023:
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p.001023: January 30, 2020
p.001023:
p.001023: (2) PREFERENCE IN MAKING AWARDS UNDER THIS SUB- SECTION.—In making awards of grants and
p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
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p.001025: practicing dentists, dental hygienists, or other approved primary care dental trainees, that emphasizes
p.001025: training for general, pediatric, or public health dentistry;
p.001025: (B) to provide financial assistance to dental students, residents, practicing dentists, and dental hygiene
p.001025: students who are in need thereof, who are participants in any such program, and who plan to work in the practice of
p.001025: general, pediatric, public heath dentistry, or dental hygiene;
p.001025: (C) to plan, develop, and operate a program for the training of oral health care providers who plan to teach
p.001025: in general, pediatric, public health dentistry, or dental hy- giene;
p.001025: (D) to provide financial assistance in the form of traineeships and fellowships to dentists who plan to
p.001025: teach or are teaching in general, pediatric, or public health den- tistry;
p.001025: (E) to meet the costs of projects to establish, maintain, or improve dental faculty development programs in pri-
p.001025: mary care (which may be departments, divisions or other units);
p.001025: (F) to meet the costs of projects to establish, maintain, or improve predoctoral and postdoctoral training in
p.001025: pri- mary care programs;
p.001025: (G) to create a loan repayment program for faculty in dental programs; and
p.001025: (H) to provide technical assistance to pediatric train- ing programs in developing and implementing
p.001025: instruction regarding the oral health status, dental care needs, and risk-based clinical disease management
p.001025: of all pediatric populations with an emphasis on underserved children.
p.001025: (2) FACULTY LOAN REPAYMENT.—
p.001025: (A) IN GENERAL.—A grant or contract under subsection (a)(1)(G) may be awarded to a program of general, pedi-
p.001025: atric, or public health dentistry described in such sub- section to plan, develop, and operate a loan repayment
p.001025: pro- gram under which—
p.001025: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: PUBLIC HEALTH SERVICE ACT
p.001027: Sec. 748
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p.001027: (i) individuals agree to serve full-time as faculty members; and
p.001027: (ii) the program of general, pediatric or public health dentistry agrees to pay the principal and inter- est on
p.001027: the outstanding student loans of the individ- uals.
p.001027: (B) MANNER OF PAYMENTS.—With respect to the pay- ments described in subparagraph (A)(ii), upon completion
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p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: Sec. 760 PUBLIC HEALTH SERVICE ACT 1052
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p.001051: in a community-based setting, followed by a vir- tual rotation in which the resident or fellow con-
p.001051: tinues to support the care of patients at the teach- ing health center or in the community-based set- ting
p.001051: through the use of health information tech- nology and, as appropriate, telehealth services;
p.001051: (II) an in-person training track that includes a rotation, during which the resident or fellow practices
p.001051: at a teaching health center or in a com- munity-based setting; or
p.001051: (III) an in-person training track that includes a rotation during which the resident practices in a
p.001051: community-based setting that specializes in the treatment of infants, children, adolescents, or pregnant
p.001051: or postpartum women; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such training.
p.001051: (2) TRAINING FOR OTHER PROVIDERS.—A recipient of a grant under subsection (a)(2)—
p.001051: (A) shall use the grant funds to plan, develop, or oper- ate a training program to provide mental and substance
p.001051: use disorders services in underserved, community-based settings, as appropriate, that integrate primary care
p.001051: and mental and substance use disorders prevention and treat- ment services; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
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p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
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p.001059: production of such books, records, correspondence, memoranda, papers, and docu- ments as the Council or
p.001059: such subcommittee may consider available; and
p.001059: (B) request the cooperation and assistance of Federal departments, agencies, and instrumentalities, and such de-
p.001059: partments, agencies, and instrumentalities are authorized to provide such cooperation and assistance.
p.001059: (2) COORDINATION OF ACTIVITIES.—The Council shall co- ordinate its activities with the activities of the
p.001059: Secretary under section 792 of the Public Health Service Act. The Secretary shall, in cooperation with the
p.001059: Council and pursuant to the rec- ommendations of the Council, take such steps as are prac- ticable to
p.001059: eliminate deficiencies in the data base established under such section 792 and shall make available in its
p.001059: reports such comprehensive data sets as are developed pursuant to this section.
p.001059: (i) REQUIREMENT REGARDING REPORTS.—In the reports re- quired under subsection (a), the Council
p.001059: shall specify its activities during the period for which the report is made.
p.001059: (j) FINAL REPORT.—Not later than April 1, 2002, the Council shall submit a final report under subsection (a).
p.001059: (k) TERMINATION.—The Council shall terminate September 30, 2003 15.
p.001059: (l) FUNDING.—Amounts otherwise appropriated under this title may be utilized by the Secretary to support the
p.001059: activities of the Council.
p.001059: SEC. 763. ø294p¿ PEDIATRIC RHEUMATOLOGY.
p.001059: (a) IN GENERAL.—The Secretary, acting through the appro- priate agencies, shall evaluate whether the
p.001059: number of pediatric rheumatologists is sufficient to address the health care needs of children with
p.001059: arthritis and related conditions, and if the Secretary determines that the number is not sufficient, shall
p.001059: develop strate- gies to help address the shortfall.
p.001059: (b) REPORT TO CONGRESS.—Not later than October 1, 2001, the Secretary shall submit to the Congress a report
p.001059: describing the re- sults of the evaluation under subsection (a), and as applicable, the strategies developed under
p.001059: such subsection.
p.001059: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001059: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001059:
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p.001059: January 30, 2020
p.001059: 15 Appropriations Acts for the Department of Health and Human Services for fiscal years 2004 and 2005 provided for
p.001059: the continued operation of the Council. See section 219 of division E of Public Law 108–199 (118 Stat.
p.001059: 255) and section 218 of division F of Public Law 108–447 (118 Stat. 3141). Each of such sections refers to
p.001059: ‘‘the Council on Graduate Education established by section 301 of Public Law 102–408’’. Such section 301 was
p.001059: transferred to the Public Health Serv- ice Act as section 762 above by section 104(b) of Public Law 105–392 (112 Stat.
p.001059: 3552).
p.001059: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
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p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001113: PUBLIC HEALTH SERVICE ACT
p.001113: Sec. 902
p.001113:
p.001113: duct and support research and evaluations, and support dem- onstration projects, with respect to—
p.001113: (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and
p.001113: (B) health care for priority populations, which shall in- clude—
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p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
p.001113: (5) health care technologies, facilities, and equipment;
p.001113: (6) health care costs, productivity, organization, and mar- ket forces;
p.001113: (7) health promotion and disease prevention, including clinical preventive services;
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p.001119: types of health care services Americans use, their access to health care services, frequency of use, how much
p.001119: is paid for the services used, the source of those pay- ments, the types and costs of private health
p.001119: insurance, access, satisfaction, and quality of care for the general population in- cluding rural residents
p.001119: and also for populations identified in section 901(c); and
p.001119: (2) develop databases and tools that provide information to States on the quality, access, and use of health
p.001119: care services provided to their residents.
p.001119: (b) QUALITY AND OUTCOMES INFORMATION.—
p.001119: (1) IN GENERAL.—Beginning in fiscal year 2001, the Direc- tor shall ensure that the survey conducted under
p.001119: subsection (a)(1) will—
p.001119: (A) identify determinants of health outcomes and func- tional status, including the health care needs of popu-
p.001119: lations identified in section 901(c), provide data to study the relationships between health care quality,
p.001119: outcomes, access, use, and cost, measure changes over time, and monitor the overall national impact of
p.001119: Federal and State policy changes on health care;
p.001119: (B) provide information on the quality of care and pa- tient outcomes for frequently occurring clinical
p.001119: conditions for a nationally representative sample of the population in- cluding rural residents; and
p.001119: (C) provide reliable national estimates for children and persons with special health care needs through the use
p.001119: of supplements or periodic expansions of the survey.
p.001119: In expanding the Medical Expenditure Panel Survey, as in ex- istence on the date of the enactment of this title in
p.001119: fiscal year 2001 to collect information on the quality of care, the Director
p.001119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001119: Sec. 914 PUBLIC HEALTH SERVICE ACT 1120
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p.001119: shall take into account any outcomes measurements generally collected by private sector accreditation
p.001119: organizations.
p.001119: (2) ANNUAL REPORT.—Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit
p.001119: to Con- gress an annual report on national trends in the quality of health care provided to the American
p.001119: people.
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p.001137:
p.001137: (C) To the extent practicable, data on such quality measures is able to be collected using health
p.001137: information technologies.
p.001137: (D) Each quality measure is free of charge to users of such measure.
p.001137: (E) Each quality measure is publicly available on an Internet website.
p.001137: (d) OTHER ACTIVITIES BY THE SECRETARY.—The Secretary may use amounts available under this section to update and
p.001137: test, where applicable, quality measures endorsed by the entity with a contract under section 1890(a) of the
p.001137: Social Security Act or adopted by the Secretary.
p.001137: (e) COORDINATION OF GRANTS.—The Secretary shall ensure that grants or contracts awarded under this section are
p.001137: coordinated with grants and contracts awarded under sections 1139A(5) and 1139B(4)(A) of the Social Security
p.001137: Act.
p.001137: (f) DEVELOPMENT OF OUTCOME MEASURES.—
p.001137: (1) IN GENERAL.—The Secretary shall develop, and periodi- cally update (not less than every 3 years),
p.001137: provider-level out- come measures for hospitals and physicians, as well as other providers as determined
p.001137: appropriate by the Secretary.
p.001137: (2) CATEGORIES OF MEASURES.—The measures developed under this subsection shall include, to the extent
p.001137: determined appropriate by the Secretary—
p.001137: (A) outcome measurement for acute and chronic dis- eases, including, to the extent feasible, the 5 most
p.001137: preva- lent and resource-intensive acute and chronic medical con- ditions; and
p.001137: (B) outcome measurement for primary and preventa- tive care, including, to the extent feasible,
p.001137: measurements that cover provision of such care for distinct patient popu- lations (such as healthy children,
p.001137: chronically ill adults, or infirm elderly individuals).
p.001137: (3) GOALS.—In developing such measures, the Secretary shall seek to—
p.001137: (A) address issues regarding risk adjustment, account- ability, and sample size;
p.001137: (B) include the full scope of services that comprise a cycle of care; and
p.001137: (C) include multiple dimensions.
p.001137: (4) TIMEFRAME.—
p.001137: (A) ACUTE AND CHRONIC DISEASES.—Not later than 24 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(A).
p.001137: (B) PRIMARY AND PREVENTIVE CARE.—Not later than 36 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(B).
p.001137:
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p.001137: January 30, 2020 As Amended Through P.L. 116-94,
p.001137: Enacted December 20, 2019
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p.001139: PUBLIC HEALTH SERVICE ACT
p.001139: Sec. 933
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p.001139: Subpart II—Health Care Quality Improvement Programs
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p.001139: January 30, 2020
p.001139:
p.001139: ture and system design of a health care organization, that con- tribute to the success and sustainability of specific
p.001139: quality im- provement and patient safety strategies;
p.001139: (8) provide for the development of best practices in the de- livery of health care services that—
p.001139: (A) have a high likelihood of success, based on struc- tured review of empirical evidence;
p.001139: (B) are specified with sufficient detail of the individual processes, steps, training, skills, and knowledge
p.001139: required for implementation and incorporation into workflow of health care practitioners in a variety of
p.001139: settings;
p.001139: (C) are designed to be readily adapted by health care providers in a variety of settings; and
p.001139: (D) where applicable, assist health care providers in working with other health care providers across the
p.001139: con- tinuum of care and in engaging patients and their families in improving the care and patient health outcomes;
p.001139: (9) provide for the funding of the activities of organizations with recognized expertise and excellence in
p.001139: improving the de- livery of health care services, including children’s health care, by involving multiple
p.001139: disciplines, managers of health care enti- ties, broad development and training, patients, caregivers and
p.001139: families, and frontline health care workers, including activities for the examination of strategies to share best
p.001139: quality improve- ment practices and to promote excellence in the delivery of health care services; and
p.001139: (10) build capacity at the State and community level to lead quality and safety efforts through education,
p.001139: training, and mentoring programs to carry out the activities under para- graphs (1) through (9).
p.001139: (c) RESEARCH FUNCTIONS OF CENTER.—
p.001139: (1) IN GENERAL.—The Center shall support, such as through a contract or other mechanism, research
p.001139: on health care delivery system improvement and the development of tools to facilitate adoption of best
p.001139: practices that improve the quality, safety, and efficiency of health care delivery services. Such support
p.001139: may include establishing a Quality Improvement Network Research Program for the purpose of testing, scaling, and
p.001139: disseminating of interventions to improve quality and effi- ciency in health care. Recipients of funding under the
p.001139: Program may include national, State, multi-State, or multi-site quality improvement networks.
p.001139: (2) RESEARCH REQUIREMENTS.—The research conducted pursuant to paragraph (1) shall—
p.001139: (A) address the priorities identified by the Secretary in the national strategic plan established under
p.001139: section 399HH;
p.001139: (B) identify areas in which evidence is insufficient to identify strategies and methodologies, taking into
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p.001141: (C) address concerns identified by health care institu- tions and providers and communicated through the Center
p.001141: pursuant to subsection (d);
p.001141: (D) reduce preventable morbidity, mortality, and asso- ciated costs of morbidity and mortality by building
p.001141: capac- ity for patient safety research;
p.001141: (E) support the discovery of processes for the reliable, safe, efficient, and responsive delivery of health
p.001141: care, tak- ing into account discoveries from clinical research and comparative effectiveness research;
p.001141: (F) allow communication of research findings and translate evidence into practice recommendations that are
p.001141: adaptable to a variety of settings, and which, as soon as practicable after the establishment of the Center,
p.001141: shall in- clude—
p.001141: (i) the implementation of a national application of Intensive Care Unit improvement projects relating to the
p.001141: adult (including geriatric), pediatric, and neonatal patient populations;
p.001141: (ii) practical methods for addressing health care associated infections, including Methicillin-Resistant
p.001141: Staphylococcus Aureus and Vancomycin-Resistant Entercoccus infections and other emerging infections; and
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p.001141: (iii) practical methods for reducing preventable hospital admissions and readmissions;
p.001141: (G) expand demonstration projects for improving the quality of children’s health care and the use of
p.001141: health in- formation technology, such as through Pediatric Quality Improvement Collaboratives and Learning
p.001141: Networks, con- sistent with provisions of section 1139A of the Social Secu- rity Act for assessing and improving
p.001141: quality, where appli- cable;
p.001141: (H) identify and mitigate hazards by—
p.001141: (i) analyzing events reported to patient safety re- porting systems and patient safety organizations; and
p.001141: (ii) using the results of such analyses to develop scientific methods of response to such events;
p.001141: (I) include the conduct of systematic reviews of exist- ing practices that improve the quality, safety,
p.001141: and effi- ciency of health care delivery, as well as new research on improving such practices; and
p.001141: (J) include the examination of how to measure and evaluate the progress of quality and patient safety
p.001141: activi- ties.
p.001141: (d) DISSEMINATION OF RESEARCH FINDINGS.—
p.001141: (1) PUBLIC AVAILABILITY.—The Director shall make the re- search findings of the Center available to the public
p.001141: through multiple media and appropriate formats to reflect the varying needs of health care providers and
p.001141: consumers and diverse lev- els of health literacy.
p.001141: (2) LINKAGE TO HEALTH INFORMATION TECHNOLOGY.—The Secretary shall ensure that research findings and
p.001141: results gen- erated by the Center are shared with the Office of the National
p.001141: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001141: Sec. 934 PUBLIC HEALTH SERVICE ACT 1142
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p.001141: Coordinator of Health Information Technology and used to in- form the activities of the health information
p.001141: technology exten- sion program under section 3012, as well as any relevant standards, certification
p.001141: criteria, or implementation specifica- tions.
p.001141: (e) PRIORITIZATION.—The Director shall identify and regularly update a list of processes or systems on
p.001141: which to focus research and dissemination activities of the Center, taking into account—
p.001141: (1) the cost to Federal health programs;
p.001141: (2) consumer assessment of health care experience;
p.001141: (3) provider assessment of such processes or systems and opportunities to minimize distress and injury to
p.001141: the health care workforce;
p.001141: (4) the potential impact of such processes or systems on health status and function of patients,
p.001141: including vulnerable populations including children;
p.001141: (5) the areas of insufficient evidence identified under sub- section (c)(2)(B); and
p.001141: (6) the evolution of meaningful use of health information technology, as defined in section 3000.
p.001141: (f) COORDINATION.—The Center shall coordinate its activities with activities conducted by the Center for Medicare
p.001141: and Medicaid Innovation established under section 1115A of the Social Security Act.
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p.001141: (g) FUNDING.—There is authorized to be appropriated to carry out this section $20,000,000 for fiscal years 2010
p.001141: through 2014.
p.001141: SEC. 934. ø299b–34¿ QUALITY IMPROVEMENT TECHNICAL ASSISTANCE AND IMPLEMENTATION.
p.001141: (a) IN GENERAL.—The Director, through the Center for Quality Improvement and Patient Safety of the Agency for
p.001141: Healthcare Re- search and Quality (referred to in this section as the ‘‘Center’’), shall award—
p.001141: (1) technical assistance grants or contracts to eligible enti- ties to provide technical support to institutions
p.001141: that deliver health care and health care providers (including rural and urban providers of services and
p.001141: suppliers with limited infra- structure and financial resources to implement and support quality improvement
p.001141: activities, providers of services and sup- pliers with poor performance scores, and providers of services
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p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and
p.001147: (C) to educate providers on the use of such materials, including through academic curricula.
p.001147: (2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient decision aids developed and produced pursuant to a
p.001147: grant or contract under paragraph (1)—
p.001147: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed
p.001147: decision- making with health care providers;
p.001147: (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and man- ner
p.001147: that is age-appropriate and can be adapted for pa- tients, caregivers, and authorized representatives
p.001147: from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and
p.001147: diverse levels of health literacy;
p.001147: (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option
p.001147: over an- other; and
p.001147: (D) shall address health care decisions across the age span, including those affecting vulnerable
p.001147: populations in- cluding children.
p.001147: (3) DISTRIBUTION.—The Director shall ensure that patient decision aids produced with grants or contracts under
p.001147: this sec- tion are available to the public.
p.001147: (4) NONDUPLICATION OF EFFORTS.—The Director shall en- sure that the activities under this section of
p.001147: the Agency and other agencies, including the Centers for Disease Control and
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001149: 1149
p.001149: PUBLIC HEALTH SERVICE ACT
p.001149: Sec. 937
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p.001149: Prevention and the National Institutes of Health, are free of unnecessary duplication of effort.
p.001149: (e) GRANTS TO SUPPORT SHARED DECISIONMAKING IMPLEMEN-
p.001149: TATION.—
p.001149: (1) IN GENERAL.—The Secretary shall establish a program to provide for the phased-in development,
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p.001165: (A) To facilitate and coordinate the delivery of edu- cation, treatment, and continuity of care for
p.001165: individuals with sickle cell disease under—
p.001165: (i) the entity’s collaborative agreement with a community-based sickle cell disease organization or a
p.001165: nonprofit entity that works with individuals who have sickle cell disease;
p.001165: (ii) the sickle cell disease newborn screening pro- gram for the State in which the entity is located; and
p.001165: (iii) the maternal and child health program under title V of the Social Security Act (42 U.S.C. 701 et seq.)
p.001165: for the State in which the entity is located.
p.001165: (B) To train nursing and other health staff who pro- vide care for individuals with sickle cell disease.
p.001165: (C) To enter into a partnership with adult or pediatric hematologists in the region and other regional experts
p.001165: in sickle cell disease at tertiary and academic health centers and State and county health offices.
p.001165: (D) To identify and secure resources for ensuring reim- bursement under the medicaid program, State children’s
p.001165: health insurance program, and other health programs for the prevention and treatment of sickle cell disease.
p.001165: (E) To provide or coordinate services for adolescents with sickle cell disease making the transition to
p.001165: adult health care.
p.001165: (3) NATIONAL COORDINATING CENTER.—
p.001165: (A) ESTABLISHMENT.—The Administrator shall enter into a contract with an entity to serve as the National Co-
p.001165: ordinating Center for the demonstration program con- ducted under this subsection.
p.001165: (B) ACTIVITIES DESCRIBED.—The National Coordi- nating Center shall—
p.001165: (i) collect, coordinate, monitor, and distribute data, best practices, and findings regarding the activi-
p.001165: ties funded under grants made to eligible entities under the demonstration program;
p.001165: (ii) develop a model protocol for eligible entities with respect to the prevention and treatment of sickle cell
p.001165: disease;
p.001165: (iii) develop educational materials regarding the prevention and treatment of sickle cell disease; and
p.001165: (iv) prepare and submit to Congress a final report that includes recommendations regarding the effec- tiveness
p.001165: of the demonstration program conducted under this subsection and such direct outcome meas- ures as—
p.001165: (I) the number and type of health care re- sources utilized (such as emergency room visits, hospital
p.001165: visits, length of stay, and physician visits for individuals with sickle cell disease); and
p.001165: (II) the number of individuals that were test- ed and subsequently received genetic counseling for the
p.001165: sickle cell trait.
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p.001167: programs.
p.001167: In carrying out this section, the Secretary may, from funds allotted for use under section 502(a) of the Social
p.001167: Security Act, make grants to or contracts with public or nonprofit private entities (including grants and
p.001167: contracts for demonstration projects).
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001167: Sec. 1108 PUBLIC HEALTH SERVICE ACT 1168
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p.001167: January 30, 2020
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p.001167: TOURETTE SYNDROME
p.001167: SEC. 1108. ø300b–7¿ (a) IN GENERAL.—The Secretary shall de- velop and implement outreach programs to educate the
p.001167: public, health care providers, educators and community based organiza- tions about the etiology, symptoms,
p.001167: diagnosis and treatment of Tourette Syndrome, with a particular emphasis on children with Tourette Syndrome.
p.001167: Such programs may be carried out by the Sec- retary directly and through awards of grants or contracts to public or
p.001167: nonprofit private entities.
p.001167: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) shall include—
p.001167: (1) the production and translation of educational materials, including public service announcements;
p.001167: (2) the development of training material for health care providers, educators and community based
p.001167: organizations; and
p.001167: (3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and
p.001167: in minor- ity groups.
p.001167: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001167: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: 1169
p.001169: PUBLIC HEALTH SERVICE ACT
p.001169: Sec. 1109
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p.001169: Sec. 1110 PUBLIC HEALTH SERVICE ACT 1170
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p.001169: January 30, 2020
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p.001169: (2) COMMENTS.—Comments received by the State after the publication described in paragraph (1) shall be addressed
p.001169: in the application for a grant under this section.
p.001169: (i) TECHNICAL ASSISTANCE.—The Secretary shall provide to en- tities receiving grants under subsection (a) such
p.001169: technical assist- ance as may be necessary to ensure the quality of programs con- ducted under this
p.001169: section.
p.001169: SEC. 1110. ø300b–9¿ EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD SCREENING AND FOLLOWUP PROGRAMS.
p.001169: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to provide for the conduct of
p.001169: demonstration programs to evaluate the effectiveness, including with respect to timeliness, of screening,
p.001169: followup, counseling or health care services in reducing the morbidity and mortality caused by
p.001169: heritable disorders in newborns and children.
p.001169: (b) DEMONSTRATION PROGRAMS.—A demonstration program conducted under a grant under this section shall be
p.001169: designed to evaluate and assess, within the jurisdiction of the entity receiving such grant—
p.001169: (1) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services for
p.001169: newborns and chil- dren at risk for heritable disorders in reducing the morbidity and mortality associated
p.001169: with such disorders, including, as ap- propriate, through the assessment of health and development outcomes for
p.001169: such children through adolescence;
p.001169: (2) the effectiveness of screening, treatment, counseling, testing, followup, or specialty services in
p.001169: accurately and reli- ably diagnosing heritable disorders in newborns and children in a timely manner;
p.001169: (3) the availability of screening, counseling, testing or spe- cialty services for newborns and children at risk
p.001169: for heritable disorders;
p.001169: (4) methods that may be identified to improve quality in the diagnosis, treatment, and disease management of
p.001169: heritable disorders based on gaps in services or care; or
p.001169: (5) methods or best practices by which the eligible entities described in section 1109 can achieve in a timely manner—
p.001169: (A) collection, delivery, receipt, and screening of new- born screening specimens; and
p.001169: (B) diagnosis of heritable disorders in newborns.
p.001169: (c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under subsection (a) an entity shall be a State or
p.001169: political subdivision of a State, or a consortium of two or more States or political subdivi- sions of States.
p.001169: SEC. 1111. ø300b–10¿ ADVISORY COMMITTEE ON HERITABLE DIS- ORDERS IN NEWBORNS AND CHILDREN.
p.001169: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the ‘‘Advisory Committee
p.001169: on Heritable Disorders in Newborns and Children’’ (referred to in this section as the ‘‘Advisory Committee’’).
p.001169: (b) DUTIES.—The Advisory Committee shall—
p.001169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001171: 1171
p.001171: PUBLIC HEALTH SERVICE ACT
p.001171: Sec. 1111
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p.001171: (1) provide advice and recommendations to the Secretary concerning grants and projects awarded or funded
p.001171: under sec- tion 1109;
p.001171: (2) provide technical information to the Secretary for the development of policies and priorities for the
p.001171: administration of grants under section 1109;
p.001171: (3) make systematic evidence-based and peer-reviewed rec- ommendations that include the heritable disorders that
p.001171: have the potential to significantly impact public health for which all newborns should be screened, including
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p.001171: (J) identification of the causes of, public health im- pacts of, and risk factors for heritable disorders;
p.001171: (K) coordination of surveillance activities, including standardized data collection and reporting,
p.001171: harmonization of laboratory definitions for heritable disorders and testing results, and confirmatory testing and
p.001171: verification of posi- tive results, in order to assess and enhance monitoring of newborn diseases; and
p.001171: (L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable
p.001171: disorders in newborns in order to ensure rapid diagnosis and fol- lowup.
p.001171: (c) MEMBERSHIP.—
p.001171: (1) IN GENERAL.—The Secretary shall appoint not to exceed
p.001171: 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001171: total member- ship of the Advisory Committee is an odd number.
p.001171: (2) REQUIRED MEMBERS.—The Secretary shall appoint to the Advisory Committee under paragraph (1)—
p.001171: (A) the Administrator of the Health Resources and Services Administration;
p.001171: (B) the Director of the Centers for Disease Control and Prevention;
p.001171: (C) the Director of the National Institutes of Health;
p.001171: (D) the Director of the Agency for Healthcare Research and Quality;
p.001171: (E) the Commissioner of the Food and Drug Adminis- tration;
p.001171: (F) medical, technical, or scientific professionals with special expertise in heritable disorders, or in
p.001171: providing screening, counseling, testing or specialty services for newborns and children at risk for
p.001171: heritable disorders;
p.001171: (G) individuals with expertise in ethics and infectious diseases who have worked and published material
p.001171: in the area of newborn screening;
p.001171: (H) members of the public having special expertise about or concern with heritable disorders; and
p.001171: (I) representatives from such Federal agencies, public health constituencies, and medical professional societies
p.001171: as
p.001171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001173: 1173
p.001173: PUBLIC HEALTH SERVICE ACT
p.001173: Sec. 1111
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p.001173: determined to be necessary by the Secretary, to fulfill the duties of the Advisory Committee, as
p.001173: established under subsection (b).
p.001173: (d) DECISION ON RECOMMENDATIONS.—
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p.001173: including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and
p.001173: (E) other relevant information as determined appro- priate by the Secretary.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001175: 1175
p.001175: PUBLIC HEALTH SERVICE ACT
p.001175: Sec. 1114
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p.001175: (c) NONDUPLICATION.—In carrying out activities under this sec- tion, the Secretary shall ensure that such activities
p.001175: minimize dupli- cation and supplement, not supplant, existing information sharing efforts.
p.001175: SEC. 1113. ø300b–12¿ LABORATORY QUALITY AND SURVEILLANCE.
p.001175: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention and
p.001175: taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children
p.001175: established under section 1111, shall provide for—
p.001175: (1) quality assurance for laboratories involved in screening newborns and children for heritable disorders,
p.001175: including qual- ity assurance for newborn-screening tests, timeliness for proc- essing such tests,
p.001175: performance evaluation services, and tech- nical assistance and technology transfer to newborn screening
p.001175: laboratories to ensure analytic validity and utility of screening tests; and
p.001175: (2) appropriate quality control and other performance test materials to evaluate the performance of new
p.001175: screening tools.
p.001175: (b) SURVEILLANCE ACTIVITIES.—The Secretary, acting through the Director of the Centers for Disease Control and
p.001175: Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders
p.001175: in Newborns and Children established under section 1111, may provide, as appropriate, for the
p.001175: coordina- tion of surveillance activities, including—
p.001175: (1) through standardized data collection and reporting, as well as the use of electronic health records; and
p.001175: (2) by promoting data sharing regarding newborn screen- ing with State-based birth defects and
p.001175: developmental disabil- ities monitoring programs.
p.001175: SEC. 1114. ø300b–13¿ INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD SCREENING.
p.001175: (a) PURPOSE.—It is the purpose of this section to—
p.001175: (1) assess existing activities and infrastructure, including activities on birth defects and developmental
p.001175: disabilities au- thorized under section 317C, in order to make recommenda- tions for programs to collect,
p.001175: analyze, and make available data on the heritable disorders recommended by the Advisory Com- mittee on Heritable
p.001175: Disorders in Newborns and Children under section 1111, including data on the incidence and prevalence of, as
p.001175: well as poor health outcomes resulting from, such dis- orders; and
p.001175: (2) make recommendations for the establishment of re- gional centers for the conduct of applied
p.001175: epidemiological re- search on effective interventions to promote the prevention of poor health outcomes
p.001175: resulting from such disorders as well as providing information and education to the public on such ef-
p.001175: fective interventions.
p.001175: (b) ESTABLISHMENT.—The Secretary shall establish an Inter- agency Coordinating Committee on Newborn and
p.001175: Child Screening (referred to in this section as the ‘‘Interagency Coordinating Com- mittee’’) to carry out
p.001175: the purpose of this section.
p.001175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001175: Sec. 1115 PUBLIC HEALTH SERVICE ACT 1176
p.001175: (c) COMPOSITION.—The Interagency Coordinating Committee shall be composed of the Director of the Centers
p.001175: for Disease Con- trol and Prevention, the Administrator of the Health Resources and Services Administration, the
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p.001175: SEC. 1116. ø300b–15¿ HUNTER KELLY RESEARCH PROGRAM.
p.001175: (a) NEWBORN SCREENING ACTIVITIES.—
p.001175: (1) IN GENERAL.—The Secretary, in conjunction with the Director of the National Institutes of Health and
p.001175: taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating,
p.001175: and expanding re- search in newborn screening (to be known as ‘‘Hunter Kelly Newborn Screening Research
p.001175: Program’’) including—
p.001175: (A) identifying, developing, and testing the most prom- ising new screening technologies, in order to improve
p.001175: al- ready existing screening tests, increase the specificity of newborn screening, and expand the number
p.001175: of conditions for which screening tests are available;
p.001175: (B) experimental treatments and disease management strategies for additional newborn conditions, and other ge-
p.001175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001177: 1177
p.001177: PUBLIC HEALTH SERVICE ACT
p.001177: Sec. 1122
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p.001177: netic, metabolic, hormonal, or functional conditions that can be detected through newborn screening
p.001177: for which treatment is not yet available;
p.001177: (C) providing research findings and data for newborn conditions under review by the Advisory Committee on
p.001177: Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel;
p.001177: (D) conducting pilot studies on conditions rec- ommended by the Advisory Committee on Heritable
p.001177: Dis- orders in Newborns and Children to ensure that screenings are ready for nationwide
p.001177: implementation; and
p.001177: (E) other activities that would improve newborn screening, as identified by the Director.
p.001177: (2) ADDITIONAL NEWBORN CONDITION.—For purposes of this subsection, the term ‘‘additional newborn condition’’ means
p.001177: any condition that is not one of the core conditions recommended by the Advisory Committee and adopted by the
p.001177: Secretary.
p.001177: (b) FUNDING.—In carrying out the research program under this section, the Secretary and the Director shall
p.001177: ensure that entities receiving funding through the program will provide assurances, as practicable, that such
p.001177: entities will work in consultation with the appropriate State departments of health, and, as practicable, focus
p.001177: their research on screening technology not currently performed in the States in which the entities are located,
p.001177: and the conditions on the uniform screening panel (or the standard test existing on the uniform screening
p.001177: panel).
p.001177: (c) REPORTS.—The Director is encouraged to include informa- tion about the activities carried out under this
p.001177: section in the bien- nial report required under section 403. If such information is in- cluded, the Director
p.001177: shall make such information available to be in- cluded on the Internet Clearinghouse established under section
p.001177: 1112.
p.001177: (d) NONDUPLICATION.—In carrying out programs under this section, the Secretary shall minimize duplication
p.001177: and supplement, not supplant, existing efforts of the type carried out under this sec- tion.
p.001177: (e) PEER REVIEW.—Nothing in this section shall be construed to interfere with the scientific peer-review
p.001177: process at the National Institutes of Health.
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p.001181: (A) an assurance from the eligible entity that the pro- posed system—
p.001181: (i) has been coordinated with the applicable State Office of Emergency Medical Services (or equivalent State
p.001181: office);
p.001181: (ii) includes consistent indirect and direct medical oversight of prehospital, hospital, and interfacility
p.001181: transport throughout the region;
p.001181: (iii) coordinates prehospital treatment and triage, hospital destination, and interfacility transport
p.001181: throughout the region;
p.001181: (iv) includes a categorization or designation sys- tem for special medical facilities throughout the region that
p.001181: is integrated with transport and destination pro- tocols;
p.001181: (v) includes a regional medical direction, patient tracking, and resource allocation system that supports
p.001181: day-to-day emergency care and surge capacity and is integrated with other components of the national and
p.001181: State emergency preparedness system; and
p.001181: (vi) addresses pediatric concerns related to inte- gration, planning, preparedness, and coordination of
p.001181: emergency medical services for infants, children and adolescents; and
p.001181: (B) such other information as the Secretary may re- quire.
p.001181: (e) REQUIREMENT OF MATCHING FUNDS.—
p.001181: (1) IN GENERAL.—The Secretary may not make a grant under this section unless the State (or consortia of
p.001181: States) in- volved agrees, with respect to the costs to be incurred by the State (or consortia) in
p.001181: carrying out the purpose for which such grant was made, to make available non-Federal contributions (in cash
p.001181: or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3
p.001181: of Federal funds provided in the grant. Such contributions may be made directly or through donations from
p.001181: public or private entities.
p.001181: (2) NON-FEDERAL CONTRIBUTIONS.—Non-Federal contribu- tions required in paragraph (1) may be in cash or in kind,
p.001181: fair- ly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts
p.001181: provided by the Federal Government, or services assisted or subsidized to any signifi-
p.001181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001183: PUBLIC HEALTH SERVICE ACT
p.001183: Sec. 1212
p.001183:
p.001183: cant extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.001183: contributions.
p.001183: (f) PRIORITY.—The Secretary shall give priority for the award of the contracts or grants described in
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p.001185: ties and expertise in the care of pediatric trauma patients), by such entity, including standards and requirements for—
p.001185: (A) the number and types of trauma patients for whom such centers must provide care in order to ensure that
p.001185: such centers will have sufficient experience and expertise to be able to provide quality care for victims of
p.001185: injury;
p.001185: (B) the resources and equipment needed by such cen- ters; and
p.001185: (C) the availability of rehabilitation services for trau- ma patients;
p.001185: (4) contains standards and requirements for the implemen- tation of regional trauma care systems, including
p.001185: standards and guidelines (consistent with the provisions of section 1867 of the Social Security Act) for
p.001185: medically directed triage and transportation of trauma patients (including patients injured in rural areas)
p.001185: prior to care in designated trauma centers;
p.001185: (5) subject to subsection (b), contains national standards and requirements, including those of the American
p.001185: Academy of Pediatrics and the American College of Emergency Physicians, for medically directed triage and
p.001185: transport of severely injured children to designated trauma centers with specified capabili- ties and
p.001185: expertise in the care of pediatric trauma patients;
p.001185: (6) utilizes a program with procedures for the evaluation of designated trauma centers (including trauma
p.001185: centers de- scribed in paragraph (5)) and trauma care systems;
p.001185: (7) provides for the establishment and collection of data in accordance with data collection requirements developed in
p.001185: con- sultation with surgical, medical, and nursing specialty groups, State and local emergency medical services
p.001185: directors, and other trained professionals in trauma care, from each designated trauma center in the State
p.001185: of a central data reporting and analysis system—
p.001185: (A) to identify the number of severely injured trauma patients and the number of deaths from trauma
p.001185: within trauma care systems in the State;
p.001185: (B) to identify the cause of the injury and any factors contributing to the injury;
p.001185: (C) to identify the nature and severity of the injury;
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p.001197: such costs in an amount that is not less than
p.001197: $1 for each $2 of Federal funds provided under the grant.
p.001197: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001197: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001197: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001197: not be included in determining the amount of such contributions.
p.001197: (d) APPLICATION FOR GRANT.—The Secretary may make a grant under subsection (a) only if an application for the
p.001197: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.001197: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
p.001197: out this section.
p.001197: (e) USE OF STATE AND AMERICAN INDIAN CONSORTIUM GRANTS.—
p.001197: (1) COMMUNITY SERVICES AND SUPPORTS.—A State or American Indian consortium shall (directly or
p.001197: through awards of contracts to nonprofit private entities) use amounts received under a grant under this section for
p.001197: the following:
p.001197: (A) To develop, change, or enhance community-based service delivery systems that include timely access to com-
p.001197: prehensive appropriate services and supports. Such service and supports—
p.001197: (i) shall promote full participation by individuals with traumatic brain injury and their families in deci- sion
p.001197: making regarding the services and supports; and
p.001197: (ii) shall be designed for children, youth, and adults with traumatic brain injury.
p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: Sec. 1252 PUBLIC HEALTH SERVICE ACT 1198
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p.001197: January 30, 2020
p.001197:
p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001219:
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p.001219: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1220
p.001219:
p.001219: service. Such term includes a health service directly associated with an organ transplant only if such
p.001219: organ transplant was re- quired to be included in basic health services on April 15, 1985. For purposes of this
p.001219: paragraph, the term ‘‘home health services’’ means health services provided at a member’s home by health care
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p.001269: intraocular pressure screening, and stress manage- ment).
p.001269: (b) The Secretary shall make a periodic survey of the needs, in- terest, attitudes, knowledge, and behavior of
p.001269: the American public regarding health and health care. The Secretary shall take into consideration the
p.001269: findings of such surveys and the findings of simi- lar surveys conducted by national and community health education
p.001269: organizations, and other organizations and agencies for formulating policy respecting health information and health
p.001269: promotion, preven- tive health services, and education in the appropriate use of health care.
p.001269:
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p.001269: January 30, 2020
p.001269:
p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
p.001269: appropriate settings representative of broad cross sections of the population, and include public edu- cation
p.001269: activities of voluntary health agencies, professional med- ical societies, and other private nonprofit health
p.001269: organizations,
p.001269: (B) focus on objectives that are measurable, and (C) emphasize
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001269:
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p.001269: Sec. 1704 PUBLIC HEALTH SERVICE ACT 1270
p.001269:
p.001269: the prevention or moderation of illness or accidents that ap- pear controllable through individual
p.001269: knowledge and behavior;
p.001269: (2) provide consultation and technical assistance to organi- zations that request help in planning, operating, or
p.001269: evaluating programs in such matters;
p.001269: (3) develop health information and health promotion mate- rials and teaching programs including (A) model
p.001269: curriculums for the training of educational and health professionals and paraprofessionals in health
p.001269: education by medical, dental, and nursing schools, schools of public health, and other institutions engaged in
p.001269: training of educational or health professionals, (B) model curriculums to be used in elementary and
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p.001287: (b) and (c), payments made to a State under section 1903 may be used for the following:
p.001287: (A) Activities consistent with making progress toward achieving the objectives established by the
p.001287: Secretary for the health status of the population of the United States for the year 2000 (in this part
p.001287: referred to as ‘‘year 2000 health objec- tives’’).
p.001287: (B) Preventive health service programs for the control of rodents and for community and school-based
p.001287: fluoridation pro- grams.
p.001287: (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and
p.001287: im- provement of such systems. Amounts for such systems may not be used for the costs of the operation of the systems
p.001287: or the pur- chase of equipment for the systems, except that such amounts may be used for the payment of not
p.001287: more than 50 percent of the costs of purchasing communications equipment for the sys- tems. Amounts may be expended
p.001287: for feasibility studies or plan- ning for the trauma-care components of such systems only if the studies or
p.001287: planning, respectively, is consistent with the re- quirements of section 1213(a).
p.001287: (D) Providing services to victims of sex offenses and for prevention of sex offenses.
p.001287: (E) The establishment, operation, and coordination of effec- tive and cost-efficient systems to reduce the
p.001287: prevalence of ill- ness due to asthma and asthma-related illnesses, especially among children, by reducing the
p.001287: level of exposure to cockroach allergen or other known asthma triggers through the use of in- tegrated pest
p.001287: management, as applied to cockroaches or other known allergens. Amounts expended for such systems may in- clude
p.001287: the costs of building maintenance and the costs of pro- grams to promote community participation in the
p.001287: carrying out at such sites of integrated pest management, as applied to
p.001287: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001287:
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p.001287: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1288
p.001287:
p.001287: cockroaches or other known allergens. For purposes of this sub- paragraph, the term ‘‘integrated pest management’’
p.001287: means an approach to the management of pests in public facilities that combines biological, cultural,
p.001287: physical, and chemical tools in a way that minimizes economic, health, and environmental risks.
p.001287: (F) With respect to activities described in any of subpara- graphs (A) through (E), related planning,
p.001287: administration, and educational activities.
p.001287: (G) Monitoring and evaluation of activities carried out under any of subparagraphs (A) through (F).
p.001287: (2) Except as provided in subsection (b), amounts paid to a State under section 1903 from its allotment
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p.001295: to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of
p.001295: law referred to in subsection (a)(1) or in violation of subsection (a)(2), the Attorney General may bring a
p.001295: civil action in any appropriate district court of the United States for such relief as may be appropriate, including
p.001295: injunctive relief.
p.001295: CRIMINAL PENALTY FOR FALSE STATEMENTS
p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
p.001295: fact in con- nection with the furnishing of items or services for which pay- ment may be made by a State from funds
p.001295: allotted to the State under this part, or
p.001295: (2) having knowledge of the occurrence of any event affect- ing his initial or continued right to any such payment
p.001295: conceals or fails to disclose such event with an intent fraudulently to se- cure such payment either in a greater
p.001295: amount than is due or when no such payment is authorized,
p.001295: shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
p.001295:
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p.001295: EMERGENCY MEDICAL SERVICES FOR CHILDREN
p.001295: SEC. 1910. ø300w–9¿ (a) For activities in addition to the activi- ties which may be carried out by States under section
p.001295: 1904(a)(1)(F), the Secretary may make grants to States or accredited schools of medicine in States to support
p.001295: a program of demonstration projects for the expansion and improvement of emergency medical services for
p.001295: children who need treatment for trauma or critical care. Any grant made under this subsection shall be
p.001295: for not more than a 4- year period (with an optional 5th year based on performance), sub- ject to annual
p.001295: evaluation by the Secretary. Only 3 grants under this subsection may be made in a State (to a State
p.001295: or to a school of medicine in such State) in any fiscal year.
p.001295: (b) The Secretary may renew a grant made under subsection
p.001295: (a) for one additional one-year period only if the Secretary deter- mines that renewal of such grant
p.001295: will provide significant benefits through the collection, analysis, and dissemination of information or data
p.001295: which will be useful to States in which grants under such subsection have not been made.
p.001295: (c) For purposes of this section—
p.001295: (1) the term ‘‘school of medicine’’ has the same meaning as in section 701(4); and
p.001295: (2) the term ‘‘accredited’’ has the same meaning as in sec- tion 701(5).
p.001295: (d) To carry out this section, there are authorized to be appro- priated $2,000,000 for fiscal year 1985 and for each
p.001295: of the two suc- ceeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000
p.001295: for each of the fiscal years 1991 and 1992, such sums as may be necessary for each of the fiscal
p.001295: years 1993 through 2005, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
p.001295: for fiscal year 2012, $28,940,625
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001295:
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p.001295: Sec. 1911 PUBLIC HEALTH SERVICE ACT 1296
p.001295:
p.001295: for fiscal year 2013, $30,387,656 for fiscal year 2014, $20,213,000 for each of fiscal years 2015
p.001295: through 2019, and $22,334,000 for each of fiscal years 2020 through 2024.
p.001295: PART B—BLOCK GRANTS REGARDING MENTAL HEALTH AND
p.001295: SUBSTANCE ABUSE
p.001295:
p.001295: Subpart I—Block Grants for Community Mental Health Services
p.001295: SEC. 1911. ø300x¿ FORMULA GRANTS TO STATES.
p.001295: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Director of the
p.001295: Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined
p.001295: in accordance with section 1918. The Secretary shall make a grant to the State of the allotment made
p.001295: for the State for the fiscal year if the State submits to the Secretary an application in accordance with
p.001295: section 1917.
p.001295: (b) PURPOSE OF GRANTS.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001295: 1916, the State in- volved will expend the grant only for the purpose of—
p.001295: (1) providing community mental health services for adults with a serious mental illness and children with a serious
p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
p.001295: health services to adults with a serious mental illness and to children with a se- rious emotional disturbance;
p.001295: (2) the plan meets the criteria specified in subsection (b);
p.001295: and
p.001295: (3) the plan is approved by the Secretary.
p.001295:
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p.001295: (b) CRITERIA FOR PLAN.—In accordance with subsection (a), a State shall submit to the Secretary a plan every
p.001295: two years that, at a minimum, includes each of the following:
p.001295: (1) SYSTEM OF CARE.—A description of the State’s system of care that contains the following:
p.001295: (A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYS- TEMS.—The plan shall—
p.001295: (i) identify the single State agency to be respon- sible for the administration of the program under
p.001295: the grant, including any third party who administers men- tal health services and is responsible for complying
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: 1297
p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
p.001297: (I) a description of the activities intended to reduce hospitalizations and hospital stays using the block
p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: Sec. 1912 PUBLIC HEALTH SERVICE ACT 1298
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p.001297:
p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001297:
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p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
p.001299: (2) STANDARDIZED METHODS.—The Secretary shall estab- lish standardized methods for making the estimates
p.001299: required in subsection (b)(11) with respect to a State. A funding agree- ment for a grant under section
p.001299: 1911 for the State is that the State will utilize such methods in making the estimates.
p.001299: (3) DATE CERTAIN FOR COMPLIANCE BY SECRETARY.—Not later than 90 days after the date of the
p.001299: enactment of the ADAMHA Reorganization Act 1, the Secretary shall establish the definitions described in
p.001299: paragraph (1), shall begin dissemi- nation of the definitions to the States, and shall establish the
p.001299: standardized methods described in paragraph (2).
p.001299: (d) REQUIREMENT OF IMPLEMENTATION OF PLAN.—
p.001299: (1) COMPLETE IMPLEMENTATION.—Except as provided in paragraph (2), in making a grant under section 1911 to a State
p.001299: for a fiscal year, the Secretary shall make a determination of the extent to which the State has
p.001299: implemented the plan re- quired in subsection (a). If the Secretary determines that a State has not
p.001299: completely implemented the plan, the Secretary shall reduce the amount of the allotment under section
p.001299: 1911 for the State for the fiscal year involved by an amount equal to 10 percent of the amount determined
p.001299: under section 1918 for the State for the fiscal year.
p.001299: (2) SUBSTANTIAL IMPLEMENTATION AND GOOD FAITH EFFORT REGARDING FISCAL YEAR 1993.—
p.001299: (A) In making a grant under section 1911 to a State for fiscal year 1993, the Secretary shall make a
p.001299: determina- tion of the extent to which the State has implemented the plan required in subsection (a). If the Secretary
p.001299: determines that the State has not substantially implemented the plan, the Secretary shall, subject to subparagraph
p.001299: (B), reduce the amount of the allotment under section 1911 for the State for such fiscal year by an amount
p.001299: equal to 10 percent of the amount determined under section 1918 for the State for the fiscal year.
p.001299: (B) In carrying out subparagraph (A), if the Secretary determines that the State is making a good faith effort to
p.001299: implement the plan required in subsection (a), the Sec- retary may make a reduction under such subparagraph in
p.001299: an amount that is less than the amount specified in such subparagraph, except that the reduction may not be
p.001299: made in an amount that is less than 5 percent of the amount de- termined under section 1918 for the State for
p.001299: fiscal year 1993.
p.001299: SEC. 1913. ø300x–2¿ CERTAIN AGREEMENTS.
p.001299: (a) ALLOCATION FOR SYSTEMS OF INTEGRATED SERVICES FOR
p.001299: CHILDREN.—
p.001299: (1) IN GENERAL.—With respect to children with a serious emotional disturbance, a funding agreement for a grant
p.001299: under section 1911 is that—
p.001299: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 10 percent of
p.001299: the grant to increase (relative to fiscal year 1992) funding for
p.001299:
p.001299:
p.001299:
p.001299: January 30, 2020
p.001299: 1 Enacted July 10, 1992.
p.001299:
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001299:
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p.001299: Sec. 1913 PUBLIC HEALTH SERVICE ACT 1300
p.001299:
p.001299: the system of integrated services described in section 1912(b)(9);
p.001299: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 10 percent of the grant
p.001299: to increase (relative to fiscal year 1993) funding for such sys- tem; and
p.001299: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such system not
p.001299: less than an amount equal to the amount expended by the State for fiscal year 1994.
p.001299: (2) WAIVER.—
p.001299: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001299: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001299: adequate level of com- prehensive community mental health services for children with a serious emotional
p.001299: distrubance 2, as indicated by a comparison of the number of such children for which such services are sought with
p.001299: the availability in the State of the services.
p.001299: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001299: 120 days after the date on which the request is made.
p.001299: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001299: in- volved.
p.001299: (b) PROVIDERS OF SERVICES.—A funding agreement for a grant under section 1911 for a State is that, with respect to the
p.001299: plan sub- mitted under section 1912(a) for the fiscal year involved—
p.001299: (1) services under the plan will be provided only through appropriate, qualified community programs (which may
p.001299: include community mental health centers, child mental-health pro- grams, psychosocial rehabilitation
p.001299: programs, mental health peer-support programs, and mental-health primary consumer- directed programs); and
p.001299: (2) services under the plan will be provided through com- munity mental health centers only if the centers
p.001299: meet the cri- teria specified in subsection (c).
p.001299: (c) CRITERIA FOR MENTAL HEALTH CENTERS.—The criteria re- ferred to in subsection (b)(2) regarding
p.001299: community mental health centers are as follows:
p.001299: (1) With respect to mental health services, the centers pro- vide services as follows:
p.001299: (A) Services principally to individuals residing in a de- fined geographic area (hereafter in this subsection referred
p.001299: to as a ‘‘service area’’).
p.001299: (B) Outpatient services, including specialized out- patient services for children, the elderly,
p.001299: individuals with a serious mental illness, and residents of the service areas of the centers who have been
p.001299: discharged from inpatient treatment at a mental health facility.
p.001299:
p.001299:
p.001299:
p.001299:
p.001299: January 30, 2020
p.001299: 2 So in law. See section 201 of Public Law 102–321 (106 Stat. 381). Probably should be ‘‘dis-
p.001299: turbance’’.
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001299:
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p.001299:
p.001301: 1301
p.001301: PUBLIC HEALTH SERVICE ACT
p.001301: Sec. 1914
p.001301:
p.001301: (C) 24-hour-a-day emergency care services.
p.001301: (D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services.
p.001301: (E) Screening for patients being considered for admis- sion to State mental health facilities to determine the
p.001301: ap- propriateness of such admission.
p.001301: (2) The mental health services of the centers are provided, within the limits of the capacities of the centers,
p.001301: to any indi- vidual residing or employed in the service area of the center regardless of ability to pay
p.001301: for such services.
p.001301: (3) The mental health services of the centers are available and accessible promptly, as appropriate and in a manner
p.001301: which preserves human dignity and assures continuity and high qual- ity care.
p.001301: SEC. 1914. ø300x–3¿ STATE MENTAL HEALTH PLANNING COUNCIL.
p.001301: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will
p.001301: establish and maintain a State mental health planning council in accordance with the condi- tions described in this
p.001301: section.
p.001301: (b) DUTIES.—A condition under subsection (a) for a Council is that the duties of the Council are—
p.001301: (1) to review plans provided to the Council pursuant to section 1915(a) by the State involved and to
p.001301: submit to the State any recommendations of the Council for modifications to the plans;
p.001301: (2) to serve as an advocate for adults with a serious men- tal illness, children with a severe emotional
p.001301: disturbance, and other individuals with mental illnesses or emotional problems; and
p.001301:
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p.001301:
p.001301:
p.001301: January 30, 2020
p.001301: (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of
p.001301: mental health serv- ices within the State.
p.001301: (c) MEMBERSHIP.—
p.001301: (1) IN GENERAL.—A condition under subsection (a) for a Council is that the Council be composed of
p.001301: residents of the State, including representatives of—
p.001301: (A) the principal State agencies with respect to—
p.001301: (i) mental health, education, vocational rehabilita- tion, criminal justice, housing, and social services; and
p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
p.001301: (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional
p.001301: dis- turbance to other members of the Council is sufficient to
p.001301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001301:
p.001301:
p.001301:
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p.001301:
p.001301: Sec. 1915 PUBLIC HEALTH SERVICE ACT 1302
p.001301:
p.001301: provide adequate representation of such children in the de- liberations of the Council; and
p.001301: (B) not less than 50 percent of the members of the Council are individuals who are not State employees
p.001301: or providers of mental health services.
p.001301: (d) DEFINITION.—For purposes of this section, the term ‘‘Coun- cil’’ means a State mental health planning council.
p.001301: SEC. 1915. ø300x–4¿ ADDITIONAL PROVISIONS.
p.001301: (a) REVIEW OF STATE PLAN BY MENTAL HEALTH PLANNING COUNCIL.—The Secretary may make a grant under section
p.001301: 1911 to a State only if—
p.001301: (1) the plan submitted under section 1912(a) with respect to the grant and the report of the State under
p.001301: section 1942(a) concerning the preceding fiscal year has been reviewed by the State mental health planning
p.001301: council under section 1914; and
p.001301: (2) the State submits to the Secretary any recommenda- tions received by the State from such council for
p.001301: modifications to the plan (without regard to whether the State has made the recommended modifications) and any comments
p.001301: concerning the annual report.
p.001301: (b) MAINTENANCE OF EFFORT REGARDING STATE EXPENDITURES FOR MENTAL HEALTH.—
p.001301: (1) IN GENERAL.—A funding agreement for a grant under section 1911 is that the State involved will maintain
p.001301: State ex- penditures for community mental health services at a level that is not less than the average
p.001301: level of such expenditures maintained by the State for the 2-year period preceding the fis- cal year for which the
p.001301: State is applying for the grant.
p.001301: (2) EXCLUSION OF CERTAIN FUNDS.—The Secretary may ex- clude from the aggregate State expenditures under
...

p.001305:
p.001305:
p.001305:
p.001305:
p.001305:
p.001305:
p.001305:
p.001305:
p.001305: January 30, 2020
p.001305:
p.001305: under clause (ii) for such District to the amount deter- mined under clause (iii).
p.001305: (ii) The amount determined under this clause for the District of Columbia is the quotient of—
p.001305: (I) the most recent 3-year arithmetic mean of total personal income in such District, as determined by the Secretary of
p.001305: Commerce; divided by
p.001305: (II) the factor determined under paragraph (8) for the District.
p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
p.001305: in clause (ii) for the District of Columbia.
p.001305: (7) DETERMINATION OF TERM ‘‘P%’’.—For purposes of para- graph (4), the term ‘‘P%’’ means the percentage
p.001305: constituted by the ratio of the term ‘‘P’’ determined under paragraph (5) for the State involved to the sum
p.001305: of the respective terms ‘‘P’’ deter- mined for the States.
p.001305: (8) DETERMINATION OF CERTAIN FACTOR.—
p.001305: (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to
p.001305: adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under
p.001305: each of sub- paragraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist
p.001305: between the State and other States in the costs of providing comprehensive community mental health services to
p.001305: adults with a serious mental ill- ness and to children with a serious emotional disturbance.
p.001305: (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year
p.001305: in- volved shall be determined according to the methodology described in the report entitled ‘‘Adjusting
p.001305: the Alcohol, Drug Abuse and Mental Health Services Block Grant Allo- cations for Poverty Populations and Cost of
p.001305: Service’’, dated March 30, 1990, and prepared by Health Economics Re- search, a corporation, pursuant to a
p.001305: contract with the Na- tional Institute on Drug Abuse.
p.001305: (C) The factor determined under this paragraph for the State involved may not for any fiscal year be
p.001305: greater than 1.1 or less than 0.9.
p.001305: (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General,
p.001305: shall in accordance with this section make a determination for each State of the factor that is to be in effect
p.001305: for the State under this paragraph. The factor so determined shall re- main in effect through fiscal year 1994,
p.001305: and shall be recal- culated every third fiscal year thereafter.
p.001305: (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the
p.001305: Federal Register, periodically make such refinements in the meth- odology referred to in subparagraph (B) as are
p.001305: consistent with the purpose described in subparagraph (A).
p.001305: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001305:
p.001305:
p.001305:
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p.001307: (2) MINIMUM ALLOTMENT FOR TERRITORIES.—The amount of an allotment under section 1911 for a territory of the
p.001307: United States for a fiscal year shall be the greater of—
p.001307: (A) the amount determined under paragraph (1) for the territory for the fiscal year;
p.001307: (B) $50,000; and
p.001307: (C) with respect to fiscal years 1993 and 1994, an amount equal to 20.6 percent of the amount received
p.001307: by the territory from allotments made pursuant to this part for fiscal year 1992.
p.001307: (3) RESERVATION OF AMOUNTS.—The Secretary shall each fiscal year reserve for the territories of the
p.001307: United States 1.5 percent of the amounts appropriated under section 1920(a) for allotments under section 1911 for the
p.001307: fiscal year.
p.001307: (4) AVAILABILITY OF DATA ON POPULATION.—With respect to data on the civilian population of the
p.001307: territories of the United States, if the Secretary determines for a fiscal year that recent such data for
p.001307: purposes of paragraph (1)(B) do not exist regarding a territory, the Secretary shall for such purposes es- timate
p.001307: the civilian population of the territory by modifying the data on the territory to reflect the average extent of change
p.001307: oc- curring during the ensuing period in the population of all terri- tories with respect to which recent such data do
p.001307: exist.
p.001307: (5) APPLICABILITY OF CERTAIN PROVISIONS.—For purposes of subsection (a), the term ‘‘State’’ does not
p.001307: include the terri- tories of the United States.
p.001307: SEC. 1919. ø300x–8¿ DEFINITIONS.
p.001307: For purposes of this subpart:
p.001307: (1) The terms ‘‘adults with a serious mental illness’’ and ‘‘children with a serious emotional
p.001307: disturbance’’ have the meanings given such terms under section 1912(c)(1).
p.001307: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1911 to a State, means that the
p.001307: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001307: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001307:
p.001307:
p.001307:
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p.001307:
p.001307: Sec. 1920 PUBLIC HEALTH SERVICE ACT 1308
p.001307:
p.001307: SEC. 1920. ø300x–9¿ FUNDING.
p.001307: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, and subpart III and
p.001307: section 505(c) with respect to mental health, there are authorized to be appropriated
p.001307: $532,571,000 for each of fiscal years 2018 through 2022.
p.001307: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, DATA COLLEC-
p.001307: TION, AND PROGRAM EVALUATION.—
p.001307: (1) IN GENERAL.—For the purpose of carrying out section 1948(a) with respect to mental health and the
p.001307: purposes speci- fied in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts
p.001307: appropriated under subsection (a) for a fiscal year.
p.001307: (2) DATA COLLECTION.—The purpose specified in this para- graph is carrying out sections 505(c) and 1971 with
p.001307: respect to mental health.
p.001307: (3) PROGRAM EVALUATION.—The purpose specified in this paragraph is the conduct of evaluations of
...

p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
p.001309: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001309: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001309: adequate level of treatments services for women described in such para-
p.001309:
p.001309: 5 Paragraph (2)(A) of section 3303(f) of Public Law 106–310 (114 Stat. 1211) provides as fol- lows:
p.001309: (2) CONFORMING AMENDMENTS.—Effective upon the publication of the regulations devel- oped in accordance with
p.001309: section 1932(e)(1) of the Public Health Service Act (42 U.S.C. 300x– 32(d))—
p.001309: (A) section 1922(c) of the Public Health Service Act (42 U.S.C. 300x–22(c)) is amended by—
p.001309:
p.001309:
p.001309:
p.001309:
p.001309: January 30, 2020
p.001309: (i) striking paragraph (2); and
p.001309: (ii) redesignating paragraph (3) as paragraph (2); and
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p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
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p.001321: Sec. 1932 PUBLIC HEALTH SERVICE ACT 1322
p.001321:
p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
p.001321: (ix) describes how the State integrates substance use disorder services and primary health care, which in
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p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
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p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
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p.001333:
p.001333: Sec. 1951 PUBLIC HEALTH SERVICE ACT 1334
p.001333:
p.001333: delegate to the States the primary responsibility for interpreting the governing provisions of this part.
p.001333: SEC. 1951. ø300x–61¿ SOLICITATION OF VIEWS OF CERTAIN ENTITIES.
p.001333: In carrying out this part, the Secretary, as appropriate, shall solicit the views of the States and other
p.001333: appropriate entities.
p.001333: SEC. 1952. 17 ø300x–62¿ AVAILABILITY TO STATES OF GRANT PAYMENTS.
p.001333: Any amounts paid to a State for a fiscal year under section 1911 or 1921 shall be available for obligation
p.001333: and expenditure until the end of the fiscal year following the fiscal year for which the amounts were paid.
p.001333: SEC. 1953. ø300x–63¿ CONTINUATION OF CERTAIN PROGRAMS.
p.001333: (a) IN GENERAL.—Of the amount allotted to the State of Ha- waii under section 1911, and the amount
p.001333: allotted to such State under section 1921, an amount equal to the proportion of Native Hawaiians residing
...

p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
p.001341:
p.001341:
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p.001341:
p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
...

p.001371: the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding.
p.001371: (3) A modification of the Vaccine Injury Table under para- graph (1) may add to, or delete from, the list of
p.001371: injuries, dis- abilities, illnesses, conditions, and deaths for which compensa- tion may be provided or may
p.001371: change the time periods for the first symptom or manifestation of the onset or the significant
p.001371: aggravation of any such injury, disability, illness, condition, or death.
p.001371: (4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions
p.001371: for com- pensation under the Program which are filed after the effective date of such regulation.
p.001371: (d) ROLE OF COMMISSION.—Except with respect to a regulation recommended by the Advisory Commission on Childhood
p.001371: Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary
p.001371: has first provided to the Commission a copy of the proposed regulation or revision, re- quested
p.001371: recommendations and comments by the Commission, and afforded the Commission at least 90 days to
p.001371: make such rec- ommendations.
p.001371: (e) 7 ADDITIONAL VACCINES.—
p.001371: (1) VACCINES RECOMMENDED BEFORE AUGUST 1, 1993.—By August 1, 1995, the Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a) to include—
p.001371: (A) vaccines which are recommended to the Secretary by the Centers for Disease Control and Prevention
p.001371: before August 1, 1993, for routine administration to children,
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 7 Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646) provides as follows:
p.001371: ‘‘(3) EFFECTIVE DATE.—A revision by the Secretary under section 2114(e) of the Public Health Service Act
p.001371: (42 U.S.C. 300aa–14(e)) (as amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to
p.001371: provide funds for compensation paid with respect to the vaccine to be added to the vaccine injury table in section
p.001371: 2114(a) of the Public Health Service Act (42 U.S.C. 300aa–14(a)).’’.
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
p.001371:
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p.001371:
p.001371: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1372
p.001371:
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (2) VACCINES RECOMMENDED AFTER AUGUST 1, 1993.—When after August 1, 1993, the Centers for Disease Control and Pre-
p.001371: vention recommends a vaccine to the Secretary for routine ad- ministration to children, the Secretary shall, within 2
p.001371: years of such recommendation, amend the Vaccine Injury Table in- cluded in subsection (a) to include—
p.001371: (A) vaccines which were recommended for routine ad- ministration to children,
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (3) VACCINES RECOMMENDED FOR USE IN PREGNANT WOMEN.—The Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines
p.001371: recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and
p.001371: the information described in subpara- graphs (B) and (C) of paragraph (2) with respect to such vac- cines.
p.001371: COMPENSATION
p.001371: SEC. 2115. ø300aa–15¿ (a) GENERAL RULE.—Compensation awarded under the Program to a petitioner under section
p.001371: 2111 for a vaccine-related injury or death associated with the administra- tion of a vaccine after the
p.001371: effective date of this part 8 shall include the following:
p.001371: (1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and
p.001371: reasonable projected unreimbursable expenses which—
p.001371: (i) result from the vaccine-related injury for which the petitioner seeks compensation,
p.001371: (ii) have been or will be incurred by or on behalf of the person who suffered such injury, and
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p.001377: rights of the petitioner with respect to the vac- cine-related injury or death for which compensation was paid,
p.001377: ex-
p.001377:
p.001377:
p.001377:
p.001377:
p.001377: January 30, 2020
p.001377: 16 Effective October 1, 1988.
p.001377: 17 See footnote for section 2112(g).
p.001377: 18 So in law. Probably should be ‘‘subrogated’’.
p.001377: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001377:
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p.001377:
p.001377: Sec. 2119 PUBLIC HEALTH SERVICE ACT 1378
p.001377:
p.001377: cept that the trust fund may not recover under such rights an amount greater than the amount of compensation
p.001377: paid to the peti- tioner.
p.001377: (b) DISPOSITION OF AMOUNTS RECOVERED.—Amounts recovered under subsection (a) shall be collected on behalf
p.001377: of, and deposited in, the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal
p.001377: Revenue Code of 1986.
p.001377: ADVISORY COMMISSION ON CHILDHOOD VACCINES
p.001377: SEC. 2119. ø300aa–19¿ (a) ESTABLISHMENT.—There is estab- lished the Advisory Commission on Childhood
p.001377: Vaccines. The Com- mission shall be composed of:
p.001377: (1) Nine members appointed by the Secretary as follows:
p.001377: (A) Three members who are health professionals, who are not employees of the United States, and who have ex- pertise in
p.001377: the health care of children, the epidemiology, eti- ology, and prevention of childhood diseases, and the ad-
p.001377: verse reactions associated with vaccines, of whom at least two shall be pediatricians.
p.001377: (B) Three members from the general public, of whom at least two shall be legal representatives of children who
p.001377: have suffered a vaccine-related injury or death.
p.001377: (C) Three members who are attorneys, of whom at least one shall be an attorney whose specialty includes
p.001377: representation of persons who have suffered a vaccine-re- lated injury or death and of whom one shall be an
p.001377: attorney whose specialty includes representation of vaccine manu- facturers.
p.001377: (2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the
p.001377: Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs (or the designees of such
p.001377: officials), each of whom shall be a nonvoting ex officio member.
p.001377: The Secretary shall select members of the Commission within 90 days of the effective date of this part. 19
p.001377: The members of the Com- mission shall select a Chair from among the members.
p.001377: (b) TERM OF OFFICE.—Appointed members of the Commission shall be appointed for a term of office of 3 years,
p.001377: except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term
p.001377: of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary.
p.001377: (c) MEETINGS.—The Commission shall first meet within 60 days after all members of the Commission are
p.001377: appointed, and thereafter shall meet not less often than four times per year and at the call of the
p.001377: chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot
p.001377: of a majority of the voting members of the Commission present at the meeting.
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p.001399: entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into
p.001399: contracts with public and private such entities, for the purpose of planning and conducting, in the
p.001399: community in- volved, clinical trials of experimental treatments for infection with the etiologic agent for such
p.001399: syndrome that are approved by the Commissioner of Food and Drugs for investigational use under reg- ulations
p.001399: issued under section 505 of the Federal Food, Drug, and Cosmetic Act.
p.001399: (b) REQUIREMENT OF CERTAIN PROJECTS.—
p.001399: (1) Financial assistance under subsection (a) shall include such assistance to community-based organizations and
p.001399: commu- nity health centers for the purpose of—
p.001399: (A) retaining appropriate medical supervision;
p.001399: (B) assisting with administration, data collection and record management; and
p.001399: (C) conducting training of community physicians, nurse practitioners, physicians’ assistants and other health
p.001399: professionals for the purpose of conducting clinical trials. (2)(A) Financial assistance under subsection
p.001399: (a) shall in- clude such assistance for demonstration projects designed to implement and conduct
p.001399: community-based clinical trials in order to provide access to the entire scope of communities af-
p.001399: fected by infections with the etiologic agent for acquired im- mune deficiency syndrome, including
p.001399: minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and
p.001399: individuals who are asymptomatic with
p.001399: respect to such infection.
p.001399:
p.001399:
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p.001399: January 30, 2020
p.001399: 3 So in law. Probably should be ‘‘acting through the Director of the National Institute’’. (Sec- tion
p.001399: 2617(b)(1) of Public Law 100–690 expressed the intent to so amend the provision; however, the amendment cannot be
p.001399: executed because the amendatory instructions are to strike ‘‘through the National Institutes of Allergy’’, and this
p.001399: term does not appear in subsection (a) (above).)
p.001399: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001399:
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p.001401: 1401
p.001401: PUBLIC HEALTH SERVICE ACT
p.001401: Sec. 2314
p.001401:
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p.001401: (B) The Director of the National Institutes of Health may not provide financial assistance under this
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p.001403: provides assur- ances of compliance satisfactory to the Secretary; and
p.001403: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001403: assurances, and information as the Secretary determines to be necessary to carry out this section.
p.001403: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001403: to be appropriated such sums as may be necessary for each fiscal year.
p.001403: SEC. 2316. ø300cc–16¿ RESEARCH CENTERS.
p.001403: (a) IN GENERAL.—
p.001403: (1) The Secretary, acting through the Director of the Na- tional Institute of Allergy and Infectious
p.001403: Diseases, may make grants to, and enter into contracts with, public and nonprofit private entities to
p.001403: assist such entities in planning, estab- lishing, or strengthening, and providing basic operating sup-
p.001403: port for, centers for basic and clinical research into, and train- ing in, advanced diagnostic, prevention, and
p.001403: treatment meth- ods for acquired immune deficiency syndrome.
p.001403: (2) A grant or contract under paragraph (1) shall be pro- vided in accordance with policies established by
p.001403: the Secretary, acting through the Director of the National Institutes of Health, and after consultation
p.001403: with the advisory council for the National Institute of Allergy and Infectious Diseases.
p.001403: (3) The Secretary shall ensure that, as appropriate, clinical research programs carried out under paragraph (1)
p.001403: include as research subjects women, children, hemophiliacs, and minori- ties.
p.001403: (b) USE OF FINANCIAL ASSISTANCE.—
p.001403: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001403:
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p.001403: Sec. 2317 PUBLIC HEALTH SERVICE ACT 1404
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p.001403: January 30, 2020
p.001403:
p.001403: (1) Financial assistance under subsection (a) may be ex- pended for—
p.001403: (A) the renovation or leasing of space;
p.001403: (B) staffing and other basic operating costs, including such patient care costs as are required for
p.001403: clinical re- search;
p.001403: (C) clinical training with respect to acquired immune deficiency syndrome (including such training for
p.001403: allied health professionals); and
p.001403: (D) demonstration purposes, including projects in the long-term monitoring and outpatient treatment of
p.001403: individ- uals infected with the etiologic agent for such syndrome.
...

p.001413: allocation shall,
p.001413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001413:
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p.001413: Sec. 2354 PUBLIC HEALTH SERVICE ACT 1414
p.001413:
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p.001413:
p.001413: January 30, 2020
p.001413:
p.001413: to the extent practicable, be made not later than 30 days after the date on which the Director
p.001413: receives amounts under paragraph (2).
p.001413: SEC. 2354. ø300cc–41¿ ADDITIONAL AUTHORITIES.
p.001413: (a) IN GENERAL.—In carrying out AIDS research, the Director of the Office—
p.001413: (1) shall develop and expand clinical trials of treatments and therapies for infection with the etiologic agent
p.001413: for acquired immune deficiency syndrome, including such clinical trials for women, infants, children,
p.001413: hemophiliacs, and minorities;
p.001413: (2) may establish or support the large-scale development and preclinical screening, production, or distribution
p.001413: of special- ized biological materials and other therapeutic substances for AIDS research and set standards of
p.001413: safety and care for persons using such materials;
p.001413: (3) may support—
p.001413: (A) AIDS research conducted outside the United States by qualified foreign professionals if such
p.001413: research can reasonably be expected to benefit the people of the United States;
p.001413: (B) collaborative research involving American and for- eign participants; and
p.001413: (C) the training of American scientists abroad and for- eign scientists in the United States;
p.001413: (4) may encourage and coordinate AIDS research con- ducted by any industrial concern that evidences
p.001413: a particular capability for the conduct of such research;
p.001413: (5)(A) may acquire, improve, repair, operate, and maintain laboratories, other research facilities, equipment,
p.001413: and such other real or personal property as the Director of the Office de- termines necessary;
p.001413: (B) may make grants for the construction or renovation of facilities; and
p.001413: (C) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34) by lease or otherwise through the
p.001413: Adminis- trator of General Services, buildings or parts of buildings in the District of Columbia or
p.001413: communities located adjacent to the District of Columbia for the use of the National Institutes of Health for
p.001413: a period not to exceed ten years; and
p.001413: (6) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
...

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p.001431: Sec. 2503 PUBLIC HEALTH SERVICE ACT 1432
p.001431:
p.001431: (2) to develop, establish, and conduct such public informa- tion activities for the general public relating to the
p.001431: prevention and diagnosis of such syndrome;
p.001431: (3) to develop, establish, and conduct activities to reduce risks relating to such syndrome, including
p.001431: research into the prevention of such syndrome;
p.001431: (4) to conduct demonstration projects for the prevention of such syndrome;
p.001431: (5) to provide technical assistance to public entities, to nonprofit private entities concerned with such
p.001431: syndrome, to schools, and to employers, for the purpose of developing infor- mation programs relating to such
p.001431: syndrome;
p.001431: (6) with respect to education and training programs for the prevention of such syndrome, to conduct such
p.001431: programs for health professionals (including allied health professionals), public safety workers
p.001431: (including emergency response employ- ees), teachers, school administrators, and other appropriate education
p.001431: personnel;
p.001431: (7) to conduct appropriate programs for educating school- aged children with respect to such syndrome,
p.001431: after consulting with local school boards;
p.001431: (8) to make available to physicians and dentists in the State information with respect to acquired
p.001431: immune deficiency syndrome, including measures for the prevention of exposure to, and the transmission of,
p.001431: the etiologic agent for such syn- drome (which information is updated not less than annually with the
p.001431: most recently available scientific date 2 relating to such syndrome);
p.001431: (9) to carry out the initial implementation of recommenda- tions contained in the guidelines and the model curriculum
p.001431: de- veloped under section 253 of the AIDS Amendments of 1988; and
p.001431: (10) to make grants to public entities, and to nonprofit pri- vate entities concerned with acquired immune
p.001431: deficiency syn- drome, for the purpose of the development, establishment, and expansion of programs for education
p.001431: directed toward individ- uals at increased risk of infection with the etiologic agent for such syndrome and
p.001431: activities to reduce the risks of exposure to such etiologic agent, with preference to programs directed to-
p.001431: ward populations in which there is significant evidence of such infection.
p.001431: SEC. 2503. ø300ee–13¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001431: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless—
p.001431: (1) the State involved submits to the Secretary a descrip- tion of the purposes for which the State intends to
p.001431: expend the payments for the fiscal year;
...

p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
p.001443: (A) IN GENERAL.—In providing for a council for pur- poses of paragraph (1), a chief elected official
p.001443: receiving a grant under section 2601(a) may establish the council di- rectly or designate an existing entity
p.001443: to serve as the coun- cil, subject to subparagraph (B).
p.001443: (B) CONSIDERATION REGARDING DESIGNATION OF COUN- CIL.—In making a determination of whether to establish or
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: 1445
p.001445: PUBLIC HEALTH SERVICE ACT
p.001445: Sec. 2602
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p.001445: communities; and
p.001445: (iii) individuals with HIV/AIDS who do not know their HIV status;
p.001445: (C) establish priorities for the allocation of funds with- in the eligible area, including how best to meet each such
p.001445: priority and additional factors that a grantee should con- sider in allocating funds under a grant based on
p.001445: the—
p.001445: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under subpara- graph (A)) and
p.001445: the needs of such population (as deter- mined under subparagraph (B));
p.001445: (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and
p.001445: interventions, to the extent that data are reasonably available;
p.001445: (iii) priorities of the communities with HIV/AIDS for whom the services are intended;
p.001445: (iv) coordination in the provision of services to such individuals with programs for HIV prevention and
p.001445: for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for
p.001445: such abuse;
p.001445: (v) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001445: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001445: Act to cover health care costs of eligible individuals and families with HIV/AIDS; and
p.001445: (vi) capacity development needs resulting from disparities in the availability of HIV-related services
p.001445: in historically underserved communities;
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1446
p.001445:
p.001445: (D) develop a comprehensive plan for the organization and delivery of health and support services described in
p.001445: section 2604 that—
p.001445: (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services
p.001445: and for informing the individuals of and ena- bling the individuals to utilize the services, giving par- ticular
p.001445: attention to eliminating disparities in access and services among affected subpopulations and his- torically
p.001445: underserved communities, and including dis- crete goals, a timetable, and an appropriate allocation of funds;
p.001445: (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (in- cluding
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p.001453: subparagraph (A) apply. A reduction under the preceding sentence may not be made in an amount that would result
p.001453: in the eli- gible area involved becoming eligible for such an in- crease.
p.001453: (C) LIMITATION.—This paragraph may not be con- strued as having any applicability after fiscal year 2013.
p.001453: (b) SUPPLEMENTAL GRANTS.—
p.001453: (1) IN GENERAL.—Subject to subsection (a)(4)(B)(i) and sec- tion 2610(d), the Secretary shall disburse the
p.001453: remainder of amounts not disbursed under section 2603(a)(2) for such fiscal year for the purpose of making grants
p.001453: under section 2601(a) to eligible areas whose application under section 2605(b)—
p.001453: (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) and the
p.001453: plan for utilization of such funds;
p.001453: (B) demonstrates the need in such area, on an objec- tive and quantified basis, for supplemental financial
p.001453: assist- ance to combat the HIV epidemic;
p.001453: (C) demonstrates the existing commitment of local re- sources of the area, both financial and in-kind, to com-
p.001453: bating the HIV epidemic;
p.001453: (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is
p.001453: im- mediately responsive and cost effective;
p.001453: (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of
p.001453: AIDS including appropriate allocations for services for infants, children, youth, women, and families with
p.001453: HIV/AIDS;
p.001453: (F) demonstrates the inclusiveness of affected commu- nities and individuals with HIV/AIDS;
p.001453: (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment
p.001453: and the statewide coordinated statement of need;
p.001453: (H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most
p.001453: recent grant year under subsection (a) for which data is available, more than 5 percent of grant funds under such
p.001453: subsection canceled, offset under subsection (c)(4), or covered by any waivers under subsection (c)(3); and
p.001453: (I) demonstrates success in identifying individuals with HIV/AIDS as described in clauses (i) through
p.001453: (iii) of paragraph (2)(A).
p.001453: (2) AMOUNT OF GRANT.—
p.001453: (A) IN GENERAL.—The amount of each grant made for purposes of this subsection shall be determined by the Sec-
p.001453: retary based on a weighting of factors under paragraph (1), with demonstrated need under subparagraph (B) of
p.001453: such paragraph counting one-third, and demonstrated success in identifying individuals with HIV/AIDS who do not
p.001453: know their HIV status and making them aware of such status counting one-third. In making such
p.001453: determination, the Secretary shall consider—
p.001453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: 1461
p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001461: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001461: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, the
p.001461: chief elected official of an eligible area, in accordance with the established priorities of the planning
p.001461: council, shall for each of such populations in the eligible area use, from the grants made for the area under
p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
p.001461: involved (infants, chil- dren, youth, or women in such area) with HIV/AIDS to the general population in
p.001461: such area of individuals with HIV/AIDS.
p.001461: (2) WAIVER.—With respect to the population involved, the Secretary may provide to the chief elected official of
p.001461: an eligible area a waiver of the requirement of paragraph (1) if such offi- cial demonstrates to the satisfaction
p.001461: of the Secretary that the population is receiving HIV-related health services through the State medicaid program
p.001461: under title XIX of the Social Security Act, the State children’s health insurance program under title XXI
p.001461: of such Act, or other Federal or State programs.
p.001461: (g) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.001461: (1) PROVISION OF SERVICE.—Subject to paragraph (2), the Secretary may not make a grant under section 2601(a) for
p.001461: the provision of services under this section in a State unless, in the case of any such service that is available
p.001461: pursuant to the State plan approved under title XIX of the Social Security Act for the State—
p.001461:
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p.001461: January 30, 2020
p.001461: (A) the political subdivision involved will provide the service directly, and the political subdivision
p.001461: has entered into a participation agreement under the State plan and is qualified to receive payments under such plan;
p.001461: or
p.001461: (B) the political subdivision will enter into an agree- ment with a public or nonprofit private entity under
p.001461: which the entity will provide the service, and the entity has en- tered into such a participation
p.001461: agreement and is qualified to receive such payments.
p.001461: (2) WAIVER.—
p.001461: (A) IN GENERAL.—In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the pro-
p.001461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
p.001473: State shall for each of such populations in the eligible area use, from the grants made for the area
p.001473: under section 2601(a) for a fiscal year, not less than the percentage constituted by the ratio of the
p.001473: population in- volved (infants, children, youth, or women in such area) with HIV/AIDS to the general
p.001473: population in such area of individuals with HIV/AIDS.
p.001473: (2) WAIVER.—With respect to the population involved, the Secretary may provide to a State a waiver of
p.001473: the requirement of paragraph (1) if such State demonstrates to the satisfaction
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001473:
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p.001475: 1475
p.001475: PUBLIC HEALTH SERVICE ACT
p.001475: Sec. 2613
p.001475:
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p.001475:
p.001475:
p.001475: January 30, 2020
p.001475: of the Secretary that the population is receiving HIV-related health services through the State medicaid
p.001475: program under title XIX of the Social Security Act, the State children’s health in- surance program under
p.001475: title XXI of such Act, or other Federal or State programs.
p.001475: (f) CONSTRUCTION.—A State may not use amounts received under a grant awarded under section 2611 to purchase or
p.001475: improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or
p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
...

p.001477: in sub- paragraph (D) and shall make available to the State or the Secretary, on request, such data and
p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001477:
p.001477: January 30, 2020
p.001477:
p.001477: (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for
p.001477: adult and pediatric HIV-related care demonstration projects; and then
p.001477: (2) to any other existing HIV care consortia.
...

p.001481: Management and Budget circular A133, from grantees within the State, in- cluding audits regarding funds
p.001481: expended in accordance with section 2611; and
p.001481: (F) carry out any other duties determined appropriate by the Secretary to facilitate the coordination of programs under
p.001481: this title.
p.001481: (5) a comprehensive plan that describes the organization and delivery of HIV health care and support
p.001481: services to be funded with assistance received under section 2611 that shall include a description of the
p.001481: purposes for which the State in- tends to use such assistance, and that—
p.001481: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001481:
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p.001481: Sec. 2617 PUBLIC HEALTH SERVICE ACT 1482
p.001481:
p.001481: (A) 7 establishes priorities for the allocation of funds within the State based on—
p.001481: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under para- graph (2))
p.001481: and the needs of such population (as deter- mined under paragraph (3));
p.001481: (ii) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001481: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001481: Act to cover health care costs of eligible individuals and families with HIV/AIDS;
p.001481: (iii) capacity development needs resulting from disparities in the availability of HIV-related services
p.001481: in historically underserved communities and rural communities; and
p.001481: (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of
p.001481: greatest need within the State;
p.001481: (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and
p.001481: for informing the individuals of and enabling the indi- viduals to utilize the services, giving particular
p.001481: attention to eliminating disparities in access and services among af- fected subpopulations and historically
p.001481: underserved commu- nities, and including discrete goals, a timetable, and an ap- propriate allocation of funds;
p.001481: (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention
p.001481: (including outreach and early intervention) and for the prevention and treatment of substance abuse
p.001481: (including programs that provide comprehensive treatment services for such abuse);
...

p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517:
p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
...

p.001519: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001519: be nec- essary to carry out this section. Such application shall include the following:
p.001519: (1) Information regarding how the expected expenditures of the grant are related to the planning process
p.001519: for localities funded under part A (including the planning process outlined in section 2602) and for States
p.001519: funded under part B (including the planning process outlined in section 2617(b)).
p.001519: (2) A specification of the expected expenditures and how those expenditures will improve overall patient
p.001519: outcomes, as outlined as part of the State plan (under section 2617(b)) or through additional outcome
p.001519: measures.
p.001519: (e) ANNUAL REVIEW OF PROGRAMS; EVALUATIONS.—
p.001519: (1) REVIEW REGARDING ACCESS TO AND PARTICIPATION IN PROGRAMS.—With respect to a grant under
p.001519: subsection (a) for an entity for a fiscal year, the Secretary shall, not later than 180 days after the
p.001519: end of the fiscal year, provide for the con- duct and completion of a review of the operation during
p.001519: the year of the program carried out under such subsection by the entity. The purpose of such review shall be
p.001519: the development of recommendations, as appropriate, for improvements in the fol- lowing:
p.001519: (A) Procedures used by the entity to allocate opportu- nities and services under subsection (a) among patients
p.001519: of the entity who are women, infants, children, or youth.
p.001519: (B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
p.001519: (2) EVALUATIONS.—— 14The Secretary shall, directly or through contracts with public and private
p.001519: entities, provide for evaluations of programs carried out pursuant to subsection (a).
p.001519: (f) ADMINISTRATIVE EXPENSES.—
p.001519: (1) LIMITATION.—A grantee may not use more than 10 per- cent of amounts received under a grant awarded under
p.001519: this section for administrative expenses.
p.001519:
p.001519:
p.001519:
p.001519: January 30, 2020
p.001519: 14 Dash so in law.
p.001519:
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001519:
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p.001519: Sec. 2681 PUBLIC HEALTH SERVICE ACT 1520
p.001519:
p.001519: (2) CLINICAL QUALITY MANAGEMENT PROGRAM.—A grantee under this section shall implement a clinical quality
p.001519: manage- ment program to assess the extent to which HIV health serv- ices provided to patients under the
p.001519: grant are consistent with the most recent Public Health Service guidelines for the treat- ment of HIV/AIDS and
p.001519: related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are
...

p.001523: in an
p.001523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: 1525
p.001525: PUBLIC HEALTH SERVICE ACT
p.001525: Sec. 2689
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p.001525: January 30, 2020
p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
p.001525: (C) NON-AIDS CASES.—The term ‘‘non-AIDS’’, with re- spect to a case of HIV, means that the individual involved
p.001525: has HIV but does not have AIDS.
p.001525: (8) HUMAN IMMUNODEFICIENCY VIRUS.—The term ‘‘human immunodeficiency virus’’ means the etiologic agent for AIDS.
...

p.001529:
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p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001531: 1531
p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
p.001531:
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p.001547: XIX of the Social Security Act or under a State child health plan under title XXI of such Act, the
p.001547: plan administrator of the group health plan shall disclose to the State, upon request, information about
p.001547: the benefits available under the group health plan in sufficient specificity, as determined under
p.001547: regulations of the Secretary of Health and Human Services in con- sultation with the Secretary that require use
p.001547: of the
p.001547: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001547:
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p.001549: 1549
p.001549: PUBLIC HEALTH SERVICE ACT
p.001549: Sec. 2705
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p.001549: January 30, 2020
p.001549: model coverage coordination disclosure form developed under section 311(b)(1)(C) of the Children’s Health In- surance
p.001549: Reauthorization Act of 2009, so as to permit the State to make a determination (under paragraph (2)(B),
p.001549: (3), or (10) of section 2105(c) of the Social Secu- rity Act or otherwise) concerning the cost-effectiveness of the
p.001549: State providing medical or child health assist- ance through premium assistance for the purchase of
p.001549: coverage under such group health plan and in order for the State to provide supplemental benefits required
p.001549: under paragraph (10)(E) of such section or other au- thority.
p.001549: (g) USE OF AFFILIATION PERIOD BY HMOS AS ALTERNATIVE TO
p.001549: PREEXISTING CONDITION EXCLUSION.—
p.001549: (1) IN GENERAL.—A health maintenance organization which offers health insurance coverage in connection
p.001549: with a group health plan and which does not impose any preexisting condition exclusion allowed under
p.001549: subsection (a) with respect to any particular coverage option may impose an affiliation pe- riod for such coverage
p.001549: option, but only if—
p.001549: (A) such period is applied uniformly without regard to any health status-related factors; and
p.001549: (B) such period does not exceed 2 months (or 3 months in the case of a late enrollee).
p.001549: (2) AFFILIATION PERIOD.—
p.001549: (A) DEFINED.—For purposes of this title, the term ‘‘af- filiation period’’ means a period which, under the terms of the
p.001549: health insurance coverage offered by the health main- tenance organization, must expire before the health insur- ance
p.001549: coverage becomes effective. The organization is not required to provide health care services or benefits during
...

p.001553: (B) A diagnostic testing program that provides a re- ward for participation and does not base any part
p.001553: of the reward on outcomes.
p.001553: (C) A program that encourages preventive care related to a health condition through the waiver of the copayment or
p.001553: deductible requirement under group health plan for the costs of certain items or services related to a health condi-
p.001553: tion (such as prenatal care or well-baby visits).
p.001553: (D) A program that reimburses individuals for the costs of smoking cessation programs without regard to
p.001553: whether the individual quits smoking.
p.001553: (E) A program that provides a reward to individuals for attending a periodic health education seminar.
p.001553: (3) WELLNESS PROGRAMS SUBJECT TO REQUIREMENTS.—If any of the conditions for obtaining a premium discount,
p.001553: rebate, or reward under a wellness program as described in paragraph (1)(C) is based on an individual satisfying
p.001553: a standard that is related to a health status factor, the wellness program shall not violate this
p.001553: section if the following requirements are com- plied with:
p.001553: (A) The reward for the wellness program, together with the reward for other wellness programs with
p.001553: respect to the plan that requires satisfaction of a standard related to a health status factor, shall not exceed 30
p.001553: percent of the cost of employee-only coverage under the plan. If, in addi- tion to employees or individuals, any
p.001553: class of dependents (such as spouses or spouses and dependent children) may participate fully in the
p.001553: wellness program, such reward shall not exceed 30 percent of the cost of the coverage in which an
p.001553: employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of cov-
p.001553: erage shall be determined based on the total amount of employer and employee contributions for the benefit
p.001553: pack- age under which the employee is (or the employee and any dependents are) receiving coverage. A reward may
p.001553: be in the form of a discount or rebate of a premium or contribu-
p.001553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001553: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1554
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p.001553: January 30, 2020
p.001553:
p.001553: tion, a waiver of all or part of a cost-sharing mechanism (such as deductibles, copayments, or
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p.001561: are not essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act, to
p.001561: the extent that such limits are otherwise permitted under Federal or State law.
p.001561: SEC. 2712. ø300gg–12¿ PROHIBITION ON RESCISSIONS.
p.001561: A group health plan and a health insurance issuer offering group or individual health insurance coverage
p.001561: shall not rescind such plan or coverage with respect to an enrollee once the enrollee is covered under such plan
p.001561: or coverage involved, except that this section shall not apply to a covered individual who has performed
p.001561: an act or practice that constitutes fraud or makes an intentional misrepresentation of material fact as
p.001561: prohibited by the terms of the plan or coverage. Such plan or coverage may not be cancelled ex- cept with
p.001561: prior notice to the enrollee, and only as permitted under section 2702(c) or 2742(b).
p.001561: SEC. 2713. ø300gg–13¿ COVERAGE OF PREVENTIVE HEALTH SERVICES.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for—
p.001561: (1) evidence-based items or services that have in effect a rating of ‘‘A’’ or ‘‘B’’ in the current
p.001561: recommendations of the United States Preventive Services Task Force;
p.001561: (2) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of
p.001561: the Centers for Disease Control and Prevention with respect to the individual involved; and
p.001561: (3) with respect to infants, children, and adolescents, evi- dence-informed preventive care and screenings
p.001561: provided for in the comprehensive guidelines supported by the Health Re- sources and Services Administration.
p.001561: (4) with respect to women, such additional preventive care and screenings not described in paragraph (1) as
p.001561: provided for in comprehensive guidelines supported by the Health Re- sources and Services Administration
p.001561: for purposes of this para- graph.
p.001561: (5) for the purposes of this Act, and for the purposes of any other provision of law, the current recommendations
p.001561: of the United States Preventive Service Task Force regarding breast cancer screening, mammography, and
p.001561: prevention shall be con- sidered the most current other than those issued in or around November 2009.
p.001561: Nothing in this subsection shall be construed to prohibit a plan or issuer from providing coverage for services in
p.001561: addition to those rec- ommended by United States Preventive Services Task Force or to deny coverage for
p.001561: services that are not recommended by such Task Force.
p.001561: (b) INTERVAL.—
p.001561: (1) IN GENERAL.—The Secretary shall establish a minimum interval between the date on which a recommendation de-
p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001561: Sec. 2714 PUBLIC HEALTH SERVICE ACT 1562
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p.001561: scribed in subsection (a)(1) or (a)(2) or a guideline under sub- section (a)(3) is issued and the plan year
p.001561: with respect to which the requirement described in subsection (a) is effective with re- spect to the service
p.001561: described in such recommendation or guideline.
p.001561: (2) MINIMUM.—The interval described in paragraph (1) shall not be less than 1 year.
p.001561: (c) VALUE-BASED INSURANCE DESIGN.—The Secretary may de- velop guidelines to permit a group health plan and a
p.001561: health insur- ance issuer offering group or individual health insurance coverage to utilize value-based
p.001561: insurance designs.
p.001561: SEC. 2714. ø300gg–14¿ EXTENSION OF DEPENDENT COVERAGE.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage that provides dependent coverage of children shall continue to make such coverage available for
p.001561: an adult child until the child turns 26 years of age. Nothing in this section shall require a health plan or a
p.001561: health insurance issuer described in the preceding sentence to make coverage available for a child of a
p.001561: child receiving dependent coverage.
p.001561: (b) REGULATIONS.—The Secretary shall promulgate regulations to define the dependents to which coverage shall be made
p.001561: available under subsection (a).
p.001561: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to modify the definition of ‘‘dependent’’
p.001561: as used in the In- ternal Revenue Code of 1986 with respect to the tax treatment of the cost of coverage.
p.001561: SEC. 2715. ø300gg–15¿ DEVELOPMENT AND UTILIZATION OF UNIFORM EXPLANATION OF COVERAGE DOCUMENTS AND STAND-
p.001561: ARDIZED DEFINITIONS.
p.001561: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Patient Protection and
p.001561: Affordable Care Act, the Secretary shall develop standards for use by a group health plan and a health
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p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
p.001585: (a) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health
p.001585: insurance coverage shall—
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p.001585: January 30, 2020
p.001585: (1) not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the
p.001585: plan or cov- erage from informing (or penalize such pharmacy for inform- ing) an enrollee of any
p.001585: differential between the enrollee’s out- of-pocket cost under the plan or coverage with respect to acqui-
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001623: medical need, taking into account regionalized systems of care.
p.001623: (D) Rapid distribution and administration of medical countermeasures.
p.001623: (E) Effective utilization of any available public and private mobile medical assets (which may include
p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
p.001623: State, local, and tribal operations in the event of a public health emergency.
p.001623: (7) COUNTERMEASURES.—
p.001623: (A) Promoting strategic initiatives to advance counter- measures to diagnose, mitigate, prevent, or treat harm
p.001623: from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally
p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
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p.001633: United States. Such rec- ommendations shall be informed by, when available and practicable, the National
p.001633: Health Security Strategy pursu- ant to section 2802, the Strategic National Stockpile needs pursuant to section
p.001633: 319F–2, and assessments of current national security threats, including chemical, biological, radiological,
p.001633: and nuclear threats, including emerging infec- tious diseases. In the event that members of the PHEMCE do not agree
p.001633: upon a recommendation, the Secretary shall provide a determination regarding such recommendation.
p.001633: (B) Identify national health security needs, including gaps in public health preparedness and response related to
p.001633: countermeasures and challenges to addressing such needs (including any regulatory challenges), and support
p.001633: align- ment of countermeasure procurement with recommenda- tions to address such needs under subparagraph (A).
p.001633: (C) Assist the Secretary in developing strategies re- lated to logistics, deployment, distribution, dispensing,
p.001633: and use of countermeasures that may be applicable to the ac- tivities of the strategic national stockpile
p.001633: under section 319F–2(a).
p.001633: (D) Provide consultation for the development of the strategy and implementation plan under section 2811(d).
p.001633: (2) INPUT.—In carrying out subparagraphs (B) and (C) of paragraph (1), the PHEMCE shall solicit and
p.001633: consider input from State, local, Tribal, and territorial public health depart- ments or officials, as
p.001633: appropriate.
p.001633: SEC. 2811A. ø42 U.S.C. 300hh–10b¿ NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.
p.001633: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security, shall establish
p.001633: an advisory com- mittee to be known as the ‘‘National Advisory Committee on Chil-
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001633:
p.001633: dren and Disasters’’ (referred to in this section as the ‘‘Advisory Committee’’).
p.001633: (b) DUTIES.—The Advisory Committee shall—
p.001633: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001633: applicable and appropriate;
p.001633: (2) evaluate and provide input with respect to the medical, mental and behavioral, and public health needs of
p.001633: children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
p.001633: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001633: and children, including related drills and exercises pursuant to the prepared- ness goals under section 2802(b).
p.001633: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001633: respect to chil- dren and the medical and public health grants and cooperative agreements as applicable
p.001633: to preparedness and response activities authorized under this title and title III.
p.001633: (d) MEMBERSHIP.—
p.001633: (1) IN GENERAL.—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint
p.001633: not to exceed 25 members to the Advisory Committee. In appointing such members, the Secretary shall ensure
p.001633: that the total mem- bership of the Advisory Committee is an odd number.
p.001633: (2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as
p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: 1635
p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
p.001635: more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
p.001635: (e) MEETINGS.—The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be
p.001635: an in-per- son meeting.
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p.001637: ery for individuals with disabilities.
p.001637: (d) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (e) DISABILITY DEFINED.—For purposes of this section, the term ‘‘disability’’ has the meaning given such term in
p.001637: section 3 of the Americans with Disabilities Act of 1990.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) RECOMMENDATION.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommendation on whether the Advisory Committee should be extended.
p.001637: SEC. 2811D. ø42 U.S.C. 300hh-10e¿ ADVISORY COMMITTEE COORDINA- TION.
p.001637: (a) IN GENERAL.—The Secretary shall coordinate duties and ac- tivities authorized under sections 2811A, 2811B,
p.001637: and 2811C, and make efforts to reduce unnecessary or duplicative reporting, or un- necessary duplicative meetings
p.001637: and recommendations under such sections, as practicable. Members of the advisory committees au- thorized
p.001637: under such sections, or their designees, shall annually meet to coordinate any recommendations, as appropriate,
p.001637: that may be similar, duplicative, or overlapping with respect to addressing the needs of children, seniors, and
p.001637: individuals with disabilities dur- ing public health emergencies. If such coordination occurs through an in-person
p.001637: meeting, it shall not be considered the required in- person meetings under any of sections
p.001637: 2811A(e), 2811B(e), or 2811C(d).
p.001637: (b) COORDINATION AND ALIGNMENT.—The Secretary, acting through the employee designated pursuant to
p.001637: section 2814, shall align preparedness and response programs or activities to address similar, dual, or
p.001637: overlapping needs of children, seniors, and individ- uals with disabilities, and any challenges in preparing
p.001637: for and re- sponding to such needs.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001639: Sec. 2812
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p.001639: (c) NOTIFICATION.—The Secretary shall annually notify the congressional committees of jurisdiction
p.001639: regarding the steps taken to coordinate, as appropriate, the recommendations under this sec- tion, and provide a
p.001639: summary description of such coordination.
p.001639: SEC. 2812. ø42 U.S.C. 300hh–11¿ NATIONAL DISASTER MEDICAL SYSTEM.
p.001639: (a) NATIONAL DISASTER MEDICAL SYSTEM.—
p.001639: (1) IN GENERAL.—The Secretary shall provide for the oper- ation in accordance with this section of a system to
p.001639: be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary
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p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
p.001649: thereby reducing family caregiver strain.
p.001649: (b) AUTHORIZATION.—Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for
p.001649: the pur- poses described in subsection (a) to eligible State agencies for which an application is submitted
p.001649: pursuant to subsection (d).
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001649: Sec. 2902 PUBLIC HEALTH SERVICE ACT 1650
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p.001649: January 30, 2020
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p.001649: (c) FEDERAL LIFESPAN APPROACH.—In carrying out this section, the Secretary shall work in cooperation with
p.001649: the National Family Caregiver Support Program of the Administration on Aging and other respite care
p.001649: programs within the Department of Health and Human Services to ensure coordination of respite care
p.001649: services for family caregivers of children and adults with special needs.
p.001649: (d) APPLICATION.—
p.001649: (1) SUBMISSION.—Each Governor desiring the eligible State agency of his or her State to receive a grant or
p.001649: cooperative agreement under this section shall submit an application on behalf of such agency to the
p.001649: Secretary at such time, in such manner, and containing such information as the Secretary shall require.
p.001649: (2) CONTENTS.—Each application submitted under this sec- tion shall include—
p.001649: (A) a description of the eligible State agency’s—
p.001649: (i) ability to work with other State and commu- nity-based agencies;
p.001649: (ii) understanding of respite care and family care- giver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) capacity to ensure meaningful involvement of family members, family caregivers, and care recipi-
p.001649: ents;
p.001649: (B) with respect to the population of family caregivers to whom respite care information or services will be
p.001649: pro- vided or for whom respite care workers and volunteers will be recruited and trained, a description of—
p.001649: (i) the population of family caregivers;
p.001649: (ii) the extent and nature of the respite care needs of that population;
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p.001649: (vi) a plan for administration, collaboration, and coordination of the proposed respite care
p.001649: activities with other related services or programs offered by public or private, nonprofit entities,
p.001649: including area agencies on aging;
p.001649: (vii) how the population, including family care- givers, care recipients, and relevant public or private
p.001649: agencies, will participate in the planning and imple- mentation of the proposed respite care activities;
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001651: PUBLIC HEALTH SERVICE ACT
p.001651: Sec. 2902
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p.001651: (viii) how the proposed respite care activities will make use, to the maximum extent feasible, of other
p.001651: Federal, State, and local funds, programs, contribu- tions, other forms of reimbursements, personnel, and
p.001651: facilities;
p.001651: (ix) respite care services available to family care- givers in the eligible State agency’s State or
p.001651: locality, including unmet needs and how the eligible State agency’s plan for use of funds will improve
p.001651: the coordi- nation and distribution of respite care services for family caregivers of children and adults
p.001651: with special needs;
p.001651: (x) the criteria used to identify family caregivers eligible for respite care services;
p.001651: (xi) how the quality and safety of any respite care services provided will be monitored, including methods to ensure
p.001651: that respite care workers and volunteers are appropriately screened and possess the necessary skills to care
p.001651: for the needs of the care recipient in the absence of the family caregiver; and
p.001651: (xii) the results expected from proposed respite care activities and the procedures to be used for evalu- ating
p.001651: those results;
p.001651: (C) assurances that, where appropriate, the eligible State agency will have a system for maintaining the
p.001651: con- fidentiality of care recipient and family caregiver records; and
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p.001651: (D) a memorandum of agreement regarding the joint responsibility for the eligible State agency’s lifespan
p.001651: res- pite program between—
p.001651: (i) the eligible State agency; and
p.001651: (ii) a public or private nonprofit statewide respite coalition or organization.
p.001651: (e) PRIORITY; CONSIDERATIONS.—When awarding grants or co- operative agreements under this section, the Secretary
p.001651: shall—
p.001651: (1) give priority to eligible State agencies that the Sec- retary determines show the greatest
p.001651: likelihood of imple- menting or enhancing lifespan respite care statewide; and
p.001651: (2) give consideration to eligible State agencies that are building or enhancing the capacity of their
p.001651: long-term care sys- tems to respond to the comprehensive needs, including respite care needs, of their residents.
p.001651: (f) USE OF GRANT OR COOPERATIVE AGREEMENT FUNDS.—
p.001651: (1) IN GENERAL.—
p.001651: (A) REQUIRED USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section shall use all or part of the funds—
p.001651: (i) to develop or enhance lifespan respite care at the State and local levels;
p.001651: (ii) to provide respite care services for family care- givers caring for children or adults;
p.001651: (iii) to train and recruit respite care workers and volunteers;
p.001651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001651: (iv) to provide information to caregivers about available respite and support services; and
p.001651: (v) to assist caregivers in gaining access to such services.
p.001651: (B) OPTIONAL USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section may use part of the funds for—
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p.001657: (i) The electronic exchange and use of health in- formation and the enterprise integration of such infor-
p.001657: mation.
p.001657: (ii) The utilization of an electronic health record for each person in the United States by 2014.
p.001657: (iii) The incorporation of privacy and security pro- tections for the electronic exchange of an individual’s
p.001657: individually identifiable health information.
p.001657: (iv) Ensuring security methods to ensure appro- priate authorization and electronic authentication of health
p.001657: information and specifying technologies or methodologies for rendering health information unus- able,
p.001657: unreadable, or indecipherable.
p.001657: (v) Specifying a framework for coordination and flow of recommendations and policies under this sub- title
p.001657: among the Secretary, the National Coordinator, the HIT Advisory Committee, the HIT Advisory Com- mittee,
p.001657: and other health information exchanges and other relevant entities.
p.001657: (vi) Methods to foster the public understanding of health information technology.
p.001657: (vii) Strategies to enhance the use of health infor- mation technology in improving the quality of health care,
p.001657: reducing medical errors, reducing health dispari- ties, improving public health, increasing prevention and
p.001657: coordination with community resources, and im- proving the continuity of care among health care set-
p.001657: tings.
p.001657: (viii) Specific plans for ensuring that populations with unique needs, such as children, are appropriately
p.001657: addressed in the technology design, as appropriate, which may include technology that automates enroll-
p.001657: ment and retention for eligible individuals.
p.001657: (B) COLLABORATION.—The strategic plan shall be up- dated through collaboration of public and private
p.001657: entities.
p.001657: (C) MEASURABLE OUTCOME GOALS.—The strategic plan update shall include measurable outcome goals.
p.001657: (D) PUBLICATION.—The National Coordinator shall re- publish the strategic plan, including all updates.
p.001657: (4) WEBSITE.—The National Coordinator shall maintain and frequently update an Internet website on which
p.001657: there is posted information on the work, schedules, reports, rec- ommendations, and other information
p.001657: to ensure transparency in promotion of a nationwide health information technology in- frastructure.
p.001657: (5) CERTIFICATION.—
p.001657: (A) IN GENERAL.—The National Coordinator, in con- sultation with the Director of the National Institute
p.001657: of Standards and Technology, shall keep or recognize a pro- gram or programs for the voluntary
p.001657: certification of health information technology as being in compliance with appli- cable certification
p.001657: criteria adopted under this subtitle. Such program shall include, as appropriate, testing of the
p.001657: technology in accordance with section 13201(b) of the
p.001657: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001657: Health Information Technology for Economic and Clinical Health Act.
p.001657: (B) CERTIFICATION CRITERIA DESCRIBED.—In this title, the term ‘‘certification criteria’’ means, with respect
p.001657: to standards and implementation specifications for health in- formation technology, criteria to establish that
p.001657: the tech- nology meets such standards and implementation speci- fications.
p.001657: (C) HEALTH INFORMATION TECHNOLOGY FOR MEDICAL SPECIALTIES AND SITES OF SERVICE.—
p.001657: (i) IN GENERAL.—The National Coordinator shall encourage, keep, or recognize, through existing au-
p.001657: thorities, the voluntary certification of health informa- tion technology under the program developed under
p.001657: subparagraph (A) for use in medical specialties and sites of service for which no such technology is
p.001657: avail- able or where more technological advancement or inte- gration is needed.
p.001657: (ii) SPECIFIC MEDICAL SPECIALTIES.—The Secretary shall accept public comment on specific medical spe- cialties
p.001657: and sites of service, in addition to those de- scribed in clause (i), for the purpose of selecting addi-
p.001657: tional specialties and sites of service as necessary.
p.001657: (iii) HEALTH INFORMATION TECHNOLOGY FOR PEDI- ATRICS.—Not later than 18 months after the date of enactment
p.001657: of the 21st Century Cures Act, the Sec- retary, in consultation with relevant stakeholders, shall
p.001657: make recommendations for the voluntary certifi- cation of health information technology for use by pe- diatric
p.001657: health providers to support the health care of children. Not later than 2 years after the date of en-
p.001657: actment of the 21st Century Cures Act, the Secretary shall adopt certification criteria under section 3004 to
p.001657: support the voluntary certification of health informa- tion technology for use by pediatric health providers to
p.001657: support the health care of children.
p.001657: (D) CONDITIONS OF CERTIFICATION.—Not later than 1 year after the date of enactment of the 21st Century Cures Act,
p.001657: the Secretary, through notice and comment rule- making, shall require, as a condition of
p.001657: certification and maintenance of certification for programs maintained or recognized under this paragraph,
p.001657: consistent with other conditions and requirements under this title, that the health information
p.001657: technology developer or entity—
p.001657: (i) does not take any action that constitutes infor- mation blocking as defined in section 3022(a);
p.001657: (ii) provides assurances satisfactory to the Sec- retary that such developer or entity, unless for
p.001657: legiti- mate purposes specified by the Secretary, will not take any action described in clause (i) or any other
p.001657: action that may inhibit the appropriate exchange, access, and use of electronic health information;
p.001657: (iii) does not prohibit or restrict communication regarding—
p.001657: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
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p.001679: and Human Services to support the electronic use and ex- change of health information.
p.001679: (2) Development and adoption of appropriate certified elec- tronic health records for categories of health care
p.001679: providers not eligible for support under title XVIII or XIX of the Social Secu- rity Act for the adoption of such
p.001679: records.
p.001679: (3) Training on and dissemination of information on best practices to integrate health information
p.001679: technology, including electronic health records, into a provider’s delivery of care, con- sistent with best
p.001679: practices learned from the Health Informa- tion Technology Research Center developed under section
p.001679: 3012(b), including community health centers receiving assist- ance under section 330, covered entities
p.001679: under section 340B, and providers participating in one or more of the programs under titles XVIII, XIX, and
p.001679: XXI of the Social Security Act (re- lating to Medicare, Medicaid, and the State Children’s Health Insurance
p.001679: Program).
p.001679: (4) Infrastructure and tools for the promotion of telemedi- cine, including coordination among Federal agencies
p.001679: in the pro- motion of telemedicine.
p.001679: (5) Promotion of the interoperability of clinical data reposi- tories or registries.
p.001679: (6) Promotion of technologies and best practices that en- hance the protection of health information by all
p.001679: holders of in- dividually identifiable health information.
p.001679: (7) Improvement and expansion of the use of health infor- mation technology by public health departments.
p.001679: (b) COORDINATION.—The Secretary shall ensure funds under this section are used in a coordinated manner with other
p.001679: health in- formation promotion activities.
p.001679: (c) ADDITIONAL USE OF FUNDS.—In addition to using funds as provided in subsection (a), the Secretary may
p.001679: use amounts appro- priated under section 3018 to carry out health information tech- nology activities
p.001679: that are provided for under laws in effect on the date of the enactment of this title.
p.001679: (d) STANDARDS FOR ACQUISITION OF HEALTH INFORMATION TECHNOLOGY.—To the greatest extent
p.001679: practicable, the Secretary shall ensure that where funds are expended under this section for the acquisition of
p.001679: health information technology, such funds shall be used to acquire health information technology that meets appli-
p.001679: cable standards adopted under section 3004. Where it is not prac- ticable to expend funds on health
p.001679: information technology that meets such applicable standards, the Secretary shall ensure that such health
p.001679: information technology meets applicable standards oth- erwise adopted by the Secretary.
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p.000297: that the entity will make available (directly or through contributions from other public or private entities)
p.000297: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of
p.000297: the amount received under the grant.
p.000297: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000297: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section such sums as may be
p.000297: necessary for each of fiscal years 2019 through 2023.
p.000297: (2) ADMINISTRATIVE COSTS.—The Secretary may use not more than 10 percent of the amount appropriated under para-
p.000297: graph (1) for a fiscal year for the administrative expenses of carrying out this section.
p.000297: SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
p.000297: (a) DEFINITIONS.—In this section:
p.000297: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider
p.000297: network that of- fers services that include mental health services provided by qualified mental health
p.000297: providers.
p.000297: (2) QUALIFIED MENTAL HEALTH PROFESSIONALS.—The term ‘‘qualified mental health professionals’’ refers to
p.000297: providers of mental health services reimbursed under the medicare pro- gram carried out under title XVIII
p.000297: of the Social Security Act (42 U.S.C. 1395 et seq.) who have additional training in the treatment of
p.000297: mental illness in children and adolescents or who have additional training in the treatment of mental illness
p.000297: in the elderly.
p.000297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000299: 299
p.000299: PUBLIC HEALTH SERVICE ACT
p.000299: Sec. 330K
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p.000299: January 30, 2020
p.000299: (3) SPECIAL POPULATIONS.—The term ‘‘special populations’’ refers to the following 2 distinct groups:
p.000299: (A) Children and adolescents in mental health under- served rural areas or in mental health underserved urban
p.000299: areas.
p.000299: (B) Elderly individuals located in long-term care facili- ties in mental health underserved rural or urban areas.
p.000299: (4) TELEHEALTH.—The term ‘‘telehealth’’ means the use of electronic information and telecommunications
p.000299: technologies to support long distance clinical health care, patient and profes- sional health-related
p.000299: education, public health, and health ad- ministration.
p.000299: (b) PROGRAM AUTHORIZED.—
p.000299: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Office for the Advancement of Telehealth
p.000299: of the Health Resources and Services Administration, shall award grants to eligible entities to establish
p.000299: demonstration projects for the provision of mental health services to special popu- lations as delivered
p.000299: remotely by qualified mental health profes- sionals using telehealth and for the provision of education re-
p.000299: garding mental illness as delivered remotely by qualified men- tal health professionals using telehealth.
p.000299: (2) POPULATIONS SERVED.—The Secretary shall award the grants under paragraph (1) in a manner that
p.000299: distributes the grants so as to serve equitably the populations described in subparagraphs (A) and (B) of
p.000299: subsection (a)(3).
p.000299: (c) USE OF FUNDS.—
p.000299: (1) IN GENERAL.—An eligible entity that receives a grant under this section shall use the grant funds—
p.000299: (A) for the populations described in subsection (a)(3)(A)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, as delivered
...

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p.000349: January 30, 2020
p.000349: HOME HEALTH SERVICES
p.000349: SEC. 339. ø255¿ (a)(1) For the purpose of encouraging the es- tablishment and initial operation of home
p.000349: health programs to pro- vide home health services in areas in which such services are inad- equate or not readily
p.000349: accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and non-
p.000349: profit private entities and loans to proprietary entities to meet the initial costs of establishing and operating
p.000349: such home health pro- grams. Such grants and loans may include funds to provide train- ing for
p.000349: paraprofessionals (including homemaker home health aides) to provide home health services.
p.000349: (2) In making grants and loans under this subsection, the Sec- retary shall—
p.000349: (A) consider the relative needs of the several States for home health services;
p.000349: (B) give preference to areas in which a high percentage of the population proposed to be served is composed of
p.000349: individuals who are elderly, medically indigent, or disabled; and
p.000349: (C) give special consideration to areas with inadequate means of transportation to obtain necessary health
p.000349: services. (3)(A) No loan may be made to a proprietary entity under this
p.000349: section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that—
p.000349: (i) at the time the application is made the entity is fiscally sound;
p.000349: (ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal
p.000349: lenders at the rate of interest prevailing in the area in which the entity is located; and
p.000349: (iii) during the period of the loan, such entity will remain fiscally sound.
p.000349: (B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on
p.000349: the date the loan is made with respect to the marketable obligations of the United States of comparable
p.000349: maturities, adjusted to provide for adminis- trative costs.
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000349:
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p.000349: Sec. 339 PUBLIC HEALTH SERVICE ACT 350
p.000349:
p.000349: (4) Applications for grants and loans under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
...

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p.000377: Sec. 340G PUBLIC HEALTH SERVICE ACT 378
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p.000377: January 30, 2020
p.000377:
p.000377: (A) the expansion or establishment of a community- based dental facility, free-standing dental clinic,
p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
...

p.000477: adults, their fami- lies, and health care providers, and that focuses on reducing falls among older adults
p.000477: and preventing repeat falls; and
p.000477: (2) award grants, contracts, or cooperative agreements to qualified organizations, institutions, or
p.000477: consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or
p.000477: fall prevention, for the purpose of orga- nizing State-level coalitions of appropriate State and
p.000477: local agencies, safety, health, senior citizen, and other organizations to design and carry out local education
p.000477: campaigns, focusing on reducing falls among older adults and preventing repeat falls.
p.000477: (b) RESEARCH.—
p.000477: (1) IN GENERAL.—The Secretary may—
p.000477: (A) conduct and support research to—
p.000477: (i) improve the identification of older adults who have a high risk of falling;
p.000477: (ii) improve data collection and analysis to identify fall risk and protective factors;
p.000477: (iii) design, implement, and evaluate the most ef- fective fall prevention interventions;
p.000477: (iv) improve strategies that are proven to be effec- tive in reducing falls by tailoring these strategies to
p.000477: specific populations of older adults;
p.000477: (v) conduct research in order to maximize the dis- semination of proven, effective fall prevention inter-
p.000477: ventions;
p.000477: (vi) intensify proven interventions to prevent falls among older adults;
p.000477: (vii) improve the diagnosis, treatment, and reha- bilitation of elderly fall victims and older adults at
p.000477: high risk for falls; and
p.000477: (viii) assess the risk of falls occurring in various settings;
p.000477: (B) conduct research concerning barriers to the adop- tion of proven interventions with respect to the
p.000477: prevention of falls among older adults;
p.000477: (C) conduct research to develop, implement, and evalu- ate the most effective approaches to reducing falls
p.000477: among high-risk older adults living in communities and long-term care and assisted living facilities; and
p.000477: (D) evaluate the effectiveness of community programs designed to prevent falls among older adults.
p.000477: (2) EDUCATIONAL SUPPORT.—The Secretary, either directly or through awarding grants, contracts, or
p.000477: cooperative agree- ments to qualified organizations, institutions, or consortia of qualified organizations
p.000477: and institutions, specializing, or dem- onstrating expertise, in falls or fall prevention, may provide
p.000477: professional education for physicians and allied health profes- sionals, and aging service providers in fall
p.000477: prevention, evalua- tion, and management.
p.000477: (c) DEMONSTRATION PROJECTS.—The Secretary may carry out the following:
p.000477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000705: Coordinating Committee for the purpose of performing the tasks described in subsection (a). 23
p.000705: SEC. 424C. ø285b–7c¿ TUBERCULOSIS.
p.000705: (a) IN GENERAL.—The Director of the National Institutes of Health may expand, intensify, and coordinate
p.000705: research and devel- opment and related activities of the Institutes with respect to tu- berculosis
p.000705: including activities toward the goal of eliminating such disease.
p.000705: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000705: (1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis;
p.000705: (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and
p.000705: (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods
p.000705: to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.
p.000705: SEC. 425. ø285b–8¿ CONGENITAL HEART DISEASE.
p.000705: (a) IN GENERAL.—The Director of the Institute may expand, in- tensify, and coordinate research and related activities
p.000705: of the Insti- tute with respect to congenital heart disease, which may include congenital heart disease
p.000705: research with respect to—
p.000705: (1) causation of congenital heart disease, including genetic causes;
p.000705: (2) long-term outcomes in individuals with congenital heart disease, including infants, children,
p.000705: teenagers, adults, and elderly individuals;
p.000705: (3) diagnosis, treatment, and prevention;
p.000705:
p.000705:
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p.000705: January 30, 2020
p.000705: 22 So in law. The section designation lacks a period. See section 521 of Public Law 106–310 (114 Stat.
p.000705: 1116).
p.000705: 23 Section 425 was repealed by section 103(b)(20) of Public Law 109–482 (120 Stat. 3688).
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
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p.000707: 707
p.000707: PUBLIC HEALTH SERVICE ACT
p.000707: Sec. 427
p.000707:
p.000707: (4) studies using longitudinal data and retrospective anal- ysis to identify effective treatments and outcomes
p.000707: for individ- uals with congenital heart disease; and
p.000707: (5) identifying barriers to life-long care for individuals with congenital heart disease.
p.000707: (b) COORDINATION OF RESEARCH ACTIVITIES.—The Director of the Institute may coordinate research efforts
p.000707: related to congenital heart disease among multiple research institutions and may de- velop research networks.
p.000707: (c) MINORITY AND MEDICALLY UNDERSERVED COMMUNITIES.— In carrying out the activities described in this section,
p.000707: the Director of the Institute shall consider the application of such research and other activities to minority and
p.000707: medically underserved commu- nities.
p.000707: Subpart 3—National Institute of Diabetes and Digestive and Kidney Diseases
p.000707: PURPOSE OF THE INSTITUTE
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p.000721: special problems and needs of the aged.
p.000721:
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p.000721: January 30, 2020
p.000721: SPECIAL FUNCTIONS
p.000721: SEC. 444. ø285e–1¿ (a) In carrying out the training responsibil- ities under this Act or any other Act for
p.000721: health and allied health professions personnel, the Secretary shall take appropriate steps to insure the education
p.000721: and training of adequate numbers of allied health, nursing, and paramedical personnel in the field of
p.000721: health care for the aged.
p.000721: (b) The Director of the Institute shall conduct scientific studies to measure the impact on the biological,
p.000721: medical, social, and psy-
p.000721: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000721:
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p.000723: 723
p.000723: PUBLIC HEALTH SERVICE ACT
p.000723: Sec. 445
p.000723:
p.000723: chological aspects of aging of programs and activities assisted or conducted by the Department of Health and
p.000723: Human Services.
p.000723: (c) The Director of the Institute shall carry out public informa- tion and education programs designed to disseminate
p.000723: as widely as possible the findings of research sponsored by the Institute, other relevant aging research
p.000723: and studies, and other information about the process of aging which may assist elderly and near-elderly per- sons
p.000723: in dealing with, and all Americans in understanding, the problems and processes associated with growing older.
p.000723: (d) The Director of the Institute shall make grants to public and private nonprofit institutions to
p.000723: conduct research relating to Alzheimer’s Disease.
p.000723: ALZHEIMER’S DISEASE CENTERS
p.000723: SEC. 445. ø285e–2¿ (a)(1) The Director of the Institute may enter into cooperative agreements with and
p.000723: make grants to public or private nonprofit entities (including university medical centers) to pay all or part
p.000723: of the cost of planning, establishing, or strength- ening, and providing basic operating support (including staffing)
p.000723: for centers for basic and clinical research (including multidisciplinary research) into, training in, and
p.000723: demonstration of advanced diag- nostic, prevention, and treatment methods for Alzheimer’s disease.
p.000723: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000723: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000723: (b)(1) Federal payments made under a cooperative agreement or grant under subsection (a) may, with respect to
p.000723: Alzheimer’s dis- ease, be used for—
p.000723: (A) diagnostic examinations, patient assessments, patient care costs, and other costs necessary for
p.000723: conducting research;
p.000723: (B) training, including training for allied health profes- sionals;
p.000723: (C) diagnostic and treatment clinics designed to meet the special needs of minority and rural populations
p.000723: and other un- derserved populations;
p.000723: (D) activities to educate the public; and
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p.000725: (d) The Director of the Institute shall establish procedures for the selection of the recipients of awards
p.000725: under this section.
p.000725: (e) Awards under this section shall be made for a one-year pe- riod, and may be renewed for not more than six
p.000725: additional consecu- tive one-year periods.
p.000725: RESEARCH PROGRAM AND PLAN
p.000725: SEC. 445C. ø285e–5¿ (a) The Director of the Institute shall con- duct, or make grants for the conduct of, research
p.000725: relevant to appro- priate services for individuals with Alzheimer’s disease and related dementias and their families.
p.000725: (b)(1) Within 6 months after the date of enactment of the Alz- heimer’s Disease and Related Dementias Services
p.000725: Research Act of 1986, the Director of the Institute shall prepare and transmit to the Chairman of the
p.000725: Council on Alzheimer’s Disease (in this section referred to as the ‘‘Council’’) a plan for the research to be conducted
p.000725: under subsection (a). The plan shall—
p.000725: (A) provide for research concerning—
p.000725: (i) the epidemiology of, and the identification of risk factors for, Alzheimer’s disease and related dementias;
p.000725: and
p.000725: (ii) the development and evaluation of reliable and valid multidimensional diagnostic and assessment proce-
p.000725: dures and instruments; and
p.000725: (B) ensure that research carried out under the plan is co- ordinated with, and uses, to the maximum
p.000725: extent feasible, re- sources of, other Federal programs relating to Alzheimer’s dis- ease and related dementias,
p.000725: including centers supported under section 445, centers supported by the National Institute of Mental Health
p.000725: on the psychopathology of the elderly, relevant activities of the Administration on Aging, other programs
p.000725: and centers involved in research on Alzheimer’s disease and related dementias supported by the Department, and
p.000725: other programs relating to Alzheimer’s disease and related dementias which are planned or conducted by
p.000725: Federal agencies other than the Department, State or local agencies, community organizations, or private
p.000725: foundations.
p.000725: (2) Within one year after transmitting the plan required under
p.000725: paragraph (1), and annually thereafter, the Director of the Insti- tute shall prepare and transmit to
p.000725: the Chairman of the Council such revisions of such plan as the Director considers appropriate.
p.000725: (c) In preparing and revising the plan required by subsection (b), the Director of the Institute shall
p.000725: consult with the Chairman of the Council and the heads of agencies within the Department.
p.000725: (d) the 28 Director of the Institute may develop, or make grants to develop—
p.000725: (1) model techniques to—
p.000725: (A) promote greater independence, including enhanced independence in performing activities of daily living and
p.000725:
p.000725:
p.000725:
p.000725: January 30, 2020
p.000725: 28 So in law. See section 9 of Public Law 102–507 (106 Stat. 3287). Probably should be ‘‘The’’.
p.000725: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000725:
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p.000725: Sec. 445D PUBLIC HEALTH SERVICE ACT 726
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p.000739: January 30, 2020
p.000739: 37 So in law. See section 2(4) of Public Law 100–553 (102 Stat. 2769). Probably should be ‘‘Di- rector of’’.
p.000739: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000741: PUBLIC HEALTH SERVICE ACT
p.000741: Sec. 464C
p.000741:
p.000741: contribute important knowledge to the understanding and elimination of disorders of hearing and other
p.000741: communication processes;
p.000741: (2) research into the evaluation of techniques (including surgical, medical, and behavioral approaches) and
p.000741: devices (in- cluding hearing aids, implanted auditory and nonauditory prosthetic devices and other
p.000741: communication aids) used in diag- nosis, treatment, rehabilitation, and prevention of disorders of hearing and other
p.000741: communication processes;
p.000741: (3) research into prevention, and early detection and diag- nosis, of hearing loss and speech and language
p.000741: disturbances (including stuttering) and research into preventing the effects of such disorders on learning and
p.000741: learning disabilities with ex- tension of programs for appropriate referral and rehabilitation;
p.000741: (4) research into the detection, treatment, and prevention of disorders of hearing and other communication
p.000741: processes in the growing elderly population with extension of rehabilitative programs to ensure continued effective
p.000741: communication skills in such population;
p.000741: (5) research to expand knowledge of the effects of environ- mental agents that influence hearing or other
p.000741: communication processes; and
p.000741: (6) developing and facilitating intramural programs on clinical and fundamental aspects of disorders of hearing
p.000741: and all other communication processes.
p.000741: DATA SYSTEM AND INFORMATION CLEARINGHOUSE
p.000741: SEC. 464B. ø285m–2¿ (a) The Director of the Institute shall es- tablish a National Deafness and Other
p.000741: Communication Disorders Data System for the collection, storage, analysis, retrieval, and dis- semination of data
p.000741: derived from patient populations with disorders of hearing or other communication processes, including where pos-
p.000741: sible, data involving general populations for the purpose of identi- fying individuals at risk of developing
p.000741: such disorders.
p.000741: (b) The Director of the Institute shall establish a National Deafness and Other Communication Disorders
p.000741: Information Clear- inghouse to facilitate and enhance, through the effective dissemina- tion of information,
p.000741: knowledge and understanding of disorders of hearing and other communication processes by health
p.000741: profes- sionals, patients, industry, and the public.
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p.000741: (A) on the importance of early detection of disorders of hearing and other communication processes, of seeking
p.000741: prompt treatment, rehabilitation, and of following an ap- propriate regimen; and
p.000741: (B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect
p.000741: dis- orders of hearing or other communication processes.
p.000741: (d) A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000741: enrolled in training pro- grams described in subsection (c)(2).
p.000741: (e) Each center assisted under this section may conduct pro- grams—
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p.000741: (1) to establish the effectiveness of new and improved methods of detection, referral, and diagnosis of
p.000741: individuals at risk of developing disorders of hearing or other communication processes; and
p.000741: (2) to disseminate the results of research, screening, and other activities, and develop means of
p.000741: standardizing patient data and recordkeeping.
p.000741: (f) The Director of the Institute shall, to the extent practicable, provide for an equitable geographical
p.000741: distribution of centers as- sisted under this section. The Director shall give appropriate con- sideration
p.000741: to the need for centers especially suited to meeting the needs of the elderly, and of children
p.000741: (particularly with respect to their education and training), affected by disorders of hearing or other
p.000741: communication processes.
p.000741: (g) Support of a center under this section may be for a period not to exceed seven years. Such period may
p.000741: be extended by the Di- rector of the Institute for one or more additional periods of not more than five
p.000741: years if the operations of such center have been re- viewed by an appropriate technical and scientific peer review
p.000741: group established by the Director, with the advice of the Institute’s advi-
p.000741: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000743: 743
p.000743: PUBLIC HEALTH SERVICE ACT
p.000743: Sec. 464D
p.000743:
p.000743: sory council, if such group has recommended to the Director that such period should be extended.
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p.000747: alco- holism and other alcohol problems;
p.000747: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000747: alco- holism and other alcohol problems;
p.000747: (E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol
p.000747: problems for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other
p.000747: specialized grad- uate students; and
p.000747: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000747: social service fields as the Secretary may require. 40
p.000747: (2) the application contains a detailed five-year plan for re- search relating to alcoholism and other alcohol
p.000747: problems.
p.000747: (b) The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to
p.000747: Centers which have been designated under this section. No funds provided under a grant under this subsection may be
p.000747: used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For
p.000747: the purposes of the preceding sentence, the term ‘‘con- struction’’ has the meaning given that term by section
p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000747: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of drug
p.000747: abuse. In carrying out the program, the Director of the Institute shall give special consider- ation to
p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
p.000747:
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p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001027:
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
p.001027: contract under subsection (a) shall be 5 years. The provision of such payments shall be subject to annual
p.001027: approval by the Secretary and subject to the availability of appropriations for the fiscal year involved to
p.001027: make the payments.
p.001027: (f) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out subsections (a) and (b), there is
p.001027: authorized to be ap- propriated $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of
p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
p.001027: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
...

p.001037: priority for primary care.
p.001037: (e) AUTHORIZATION.—There is authorized to be appropriated to carry out this section $5,000,000 for each of the
p.001037: fiscal years 2010 through 2014, and such sums as may be necessary for each subse- quent fiscal year.
p.001037: SEC. 753. ø294c¿ EDUCATION AND TRAINING RELATING TO GERI- ATRICS.
p.001037: (a) GERIATRIC EDUCATION CENTERS.—
p.001037: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to entities described in
p.001037: paragraphs 11 (1), (3), or (4) of section 799B, and section 801(2), for the estab- lishment or operation of geriatric
p.001037: education centers.
p.001037: (2) REQUIREMENTS.—A geriatric education center is a pro- gram that—
p.001037:
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p.001037: January 30, 2020
p.001037: 11 So in law. Probably should read ‘‘paragraph’’.
p.001037: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001039: 1039
p.001039: PUBLIC HEALTH SERVICE ACT
p.001039: Sec. 753
p.001039:
p.001039: (A) improves the training of health professionals in geriatrics, including geriatric residencies,
p.001039: traineeships, or fellowships;
p.001039: (B) develops and disseminates curricula relating to the treatment of the health problems of elderly individuals;
p.001039: (C) supports the training and retraining of faculty to provide instruction in geriatrics;
p.001039: (D) supports continuing education of health profes- sionals who provide geriatric care; and
p.001039: (E) provides students with clinical training in geri- atrics in nursing homes, chronic and acute disease
p.001039: hos- pitals, ambulatory care centers, and senior centers.
p.001039: (b) GERIATRIC TRAINING REGARDING PHYSICIANS AND DEN-
p.001039: TISTS.—
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p.001039: (1) IN GENERAL.—The Secretary may make grants to, and enter into contracts with, schools of medicine, schools
p.001039: of osteo- pathic medicine, teaching hospitals, and graduate medical edu- cation programs, for the purpose of
p.001039: providing support (includ- ing residencies, traineeships, and fellowships) for geriatric training
p.001039: projects to train physicians, dentists and behavioral and mental health professionals who plan to teach
p.001039: geriatric medicine, geriatric behavioral or mental health, or geriatric dentistry.
p.001039: (2) REQUIREMENTS.—Each project for which a grant or con- tract is made under this subsection shall—
p.001039: (A) be staffed by full-time teaching physicians who have experience or training in geriatric medicine or
p.001039: geri- atric behavioral or mental health;
p.001039: (B) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching dentists
p.001039: who have experience or training in geriatric dentistry;
p.001039: (C) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching
p.001039: behav- ioral mental health professionals who have experience or training in geriatric behavioral or mental
p.001039: health;
p.001039: (D) be based in a graduate medical education program in internal medicine or family medicine or in a department of
p.001039: geriatrics or behavioral or mental health;
p.001039: (E) provide training in geriatrics and exposure to the physical and mental disabilities of elderly
p.001039: individuals through a variety of service rotations, such as geriatric consultation services, acute care
p.001039: services, dental services, geriatric behavioral or mental health units, day and home care programs, rehabilitation
p.001039: services, extended care facili- ties, geriatric ambulatory care and comprehensive evalua- tion units, and
p.001039: community care programs for elderly indi- viduals with intellectual disabilities; and
p.001039: (F) provide training in geriatrics through one or both of the training options described in subparagraphs (A)
p.001039: and
p.001039: (B) of paragraph (3).
p.001039: (3) TRAINING OPTIONS.—The training options referred to in subparagraph (F) of paragraph (2) shall be as follows:
p.001039: (A) A 1-year retraining program in geriatrics for—
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001039: Sec. 753 PUBLIC HEALTH SERVICE ACT 1040
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p.001039:
p.001039: (i) physicians who are faculty members in depart- ments of internal medicine, family medicine, gyne- cology,
p.001039: geriatrics, and behavioral or mental health at schools of medicine and osteopathic medicine;
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p.001045: hospitals, community health centers, migrant health centers, rural health clinics, community behavioral and
p.001045: mental health centers, long-term care facilities, Native Hawaiian health centers, or facilities op- erated by the
p.001045: Indian Health Service or an Indian tribe or tribal organization or Indian organization under a contract with
p.001045: the Indian Health Service under the Indian Self-Determination Act.
p.001045: (d) DEFINITIONS.—For the purposes of this section, the term ‘‘rural’’ means geographic areas that are located
p.001045: outside of standard metropolitan statistical areas.
p.001045: SEC. 755. ø294e¿ ALLIED HEALTH AND OTHER DISCIPLINES.
p.001045: (a) IN GENERAL.—The Secretary may make grants or contracts under this section to help entities fund activities
p.001045: of the type de- scribed in subsection (b).
p.001045: (b) ACTIVITIES.—Activities of the type described in this sub- section include the following:
p.001045: (1) Assisting entities in meeting the costs associated with expanding or establishing programs that
p.001045: will increase the number of individuals trained in allied health professions. Pro- grams and activities funded
p.001045: under this paragraph may in- clude—
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p.001045: (A) those that expand enrollments in allied health pro- fessions with the greatest shortages or whose services
p.001045: are most needed by the elderly;
p.001045: (B) those that provide rapid transition training pro- grams in allied health fields to individuals who
p.001045: have bac- calaureate degrees in health-related sciences;
p.001045: (C) those that establish community-based allied health training programs that link academic centers to rural clin- ical
p.001045: settings;
p.001045: (D) those that provide career advancement training for practicing allied health professionals;
p.001045: (E) those that expand or establish clinical training sites for allied health professionals in medically
p.001045: under-
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: Sec. 756 PUBLIC HEALTH SERVICE ACT 1046
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p.001045: served or rural communities in order to increase the num- ber of individuals trained;
p.001045: (F) those that develop curriculum that will emphasize knowledge and practice in the areas of prevention and
p.001045: health promotion, geriatrics, long-term care, home health and hospice care, and ethics;
p.001045: (G) those that expand or establish interdisciplinary training programs that promote the effectiveness of
p.001045: allied health practitioners in geriatric assessment and the reha- bilitation of the elderly;
p.001045: (H) those that expand or establish demonstration cen- ters to emphasize innovative models to link allied health
p.001045: clinical practice, education, and research;
p.001045: (I) those that provide financial assistance (in the form of traineeships) to students who are participants in
p.001045: any such program; and
p.001045: (i) who plan to pursue a career in an allied health field that has a demonstrated personnel shortage; and
p.001045: (ii) who agree upon completion of the training pro- gram to practice in a medically underserved commu- nity;
p.001045: that shall be utilized to assist in the payment of all or part of the costs associated with tuition, fees and such
p.001045: other sti- pends as the Secretary may consider necessary; and
p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
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p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
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p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
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p.001109: (3) inform the public of financial assistance regarding such education programs;
p.001109: (4) highlight individuals in the community who are prac- ticing nursing in order to recruit new nurses; or
p.001109: (5) provide any other information to recruit individuals for the nursing profession.
p.001109: (c) LIMITATION.—An eligible entity that receives a grant under subsection (a) shall not use funds received
p.001109: through such grant to advertise particular employment opportunities.
p.001109: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001109: sums as may be necessary for each of fiscal years 2003 through 2007.
p.001109:
p.001109: January 30, 2020 As Amended Through P.L. 116-94,
p.001109: Enacted December 20, 2019
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p.001111: 1111
p.001111: PUBLIC HEALTH SERVICE ACT
p.001111: Sec. 871
p.001111:
p.001111: PART H—COMPREHENSIVE GERIATRIC EDUCATION
p.001111: SEC. 865. ø298¿ COMPREHENSIVE GERIATRIC EDUCATION.
p.001111: (a) PROGRAM AUTHORIZED.—The Secretary shall award grants to eligible entities to develop and
p.001111: implement, in coordination with programs under section 753, programs and initiatives to train and educate
p.001111: individuals in providing geriatric care for the elderly.
p.001111: (b) USE OF FUNDS.—An eligible entity that receives a grant under subsection (a) shall use funds under such
p.001111: grant to—
p.001111: (1) provide training to individuals who will provide geri- atric care for the elderly;
p.001111: (2) develop and disseminate curricula relating to the treat- ment of the health problems of elderly individuals;
p.001111: (3) train faculty members in geriatrics;
p.001111: (4) provide continuing education to individuals who pro- vide geriatric care; or
p.001111: (5) establish traineeships for individuals who are pre- paring for advanced education nursing
p.001111: degrees in geriatric nursing, long-term care, gero-psychiatric nursing or other nurs- ing areas that specialize
p.001111: in the care of the elderly population.
p.001111: (c) APPLICATION.—An eligible entity desiring a grant under subsection (a) shall submit an application to the
p.001111: Secretary at such time, in such manner, and containing such information as the Sec- retary may reasonably require.
p.001111: (d) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ includes a school of nursing, a
p.001111: health care facility, a program leading to certification as a certified nurse assistant, a partnership of
p.001111: such a school and facility, or a partnership of such a program and facility.
p.001111: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001111: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001111: PART I—FUNDING
p.001111: SEC. 871. ø298d¿ AUTHORIZATION OF APPROPRIATIONS.
p.001111: For the purpose of carrying out parts B, C, and D (subject to section 851(g)), there are
p.001111: authorized to be appropriated
p.001111: $338,000,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011
p.001111: through 2016.
p.001111:
p.001111:
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p.001111:
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p.001111:
p.001111: January 30, 2020 As Amended Through P.L. 116-94,
p.001111: Enacted December 20, 2019
p.001111:
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p.001111:
p.001111: Sec. 901 PUBLIC HEALTH SERVICE ACT 1112
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p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001111:
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p.001113: 1113
p.001113: PUBLIC HEALTH SERVICE ACT
p.001113: Sec. 902
p.001113:
p.001113: duct and support research and evaluations, and support dem- onstration projects, with respect to—
p.001113: (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and
p.001113: (B) health care for priority populations, which shall in- clude—
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p.001113: January 30, 2020
p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
p.001113: (5) health care technologies, facilities, and equipment;
p.001113: (6) health care costs, productivity, organization, and mar- ket forces;
p.001113: (7) health promotion and disease prevention, including clinical preventive services;
p.001113: (8) health statistics, surveys, database development, and epidemiology; and
p.001113: (9) medical liability.
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p.001137: (D) Each quality measure is free of charge to users of such measure.
p.001137: (E) Each quality measure is publicly available on an Internet website.
p.001137: (d) OTHER ACTIVITIES BY THE SECRETARY.—The Secretary may use amounts available under this section to update and
p.001137: test, where applicable, quality measures endorsed by the entity with a contract under section 1890(a) of the
p.001137: Social Security Act or adopted by the Secretary.
p.001137: (e) COORDINATION OF GRANTS.—The Secretary shall ensure that grants or contracts awarded under this section are
p.001137: coordinated with grants and contracts awarded under sections 1139A(5) and 1139B(4)(A) of the Social Security
p.001137: Act.
p.001137: (f) DEVELOPMENT OF OUTCOME MEASURES.—
p.001137: (1) IN GENERAL.—The Secretary shall develop, and periodi- cally update (not less than every 3 years),
p.001137: provider-level out- come measures for hospitals and physicians, as well as other providers as determined
p.001137: appropriate by the Secretary.
p.001137: (2) CATEGORIES OF MEASURES.—The measures developed under this subsection shall include, to the extent
p.001137: determined appropriate by the Secretary—
p.001137: (A) outcome measurement for acute and chronic dis- eases, including, to the extent feasible, the 5 most
p.001137: preva- lent and resource-intensive acute and chronic medical con- ditions; and
p.001137: (B) outcome measurement for primary and preventa- tive care, including, to the extent feasible,
p.001137: measurements that cover provision of such care for distinct patient popu- lations (such as healthy children,
p.001137: chronically ill adults, or infirm elderly individuals).
p.001137: (3) GOALS.—In developing such measures, the Secretary shall seek to—
p.001137: (A) address issues regarding risk adjustment, account- ability, and sample size;
p.001137: (B) include the full scope of services that comprise a cycle of care; and
p.001137: (C) include multiple dimensions.
p.001137: (4) TIMEFRAME.—
p.001137: (A) ACUTE AND CHRONIC DISEASES.—Not later than 24 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(A).
p.001137: (B) PRIMARY AND PREVENTIVE CARE.—Not later than 36 months after the date of enactment of this Act, the Sec-
p.001137: retary shall develop not less than 10 measures described in paragraph (2)(B).
p.001137:
p.001137:
p.001137: January 30, 2020 As Amended Through P.L. 116-94,
p.001137: Enacted December 20, 2019
p.001137:
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p.001139: 1139
p.001139: PUBLIC HEALTH SERVICE ACT
p.001139: Sec. 933
p.001139:
p.001139: Subpart II—Health Care Quality Improvement Programs
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p.001299: the availability in the State of the services.
p.001299: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001299: 120 days after the date on which the request is made.
p.001299: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001299: in- volved.
p.001299: (b) PROVIDERS OF SERVICES.—A funding agreement for a grant under section 1911 for a State is that, with respect to the
p.001299: plan sub- mitted under section 1912(a) for the fiscal year involved—
p.001299: (1) services under the plan will be provided only through appropriate, qualified community programs (which may
p.001299: include community mental health centers, child mental-health pro- grams, psychosocial rehabilitation
p.001299: programs, mental health peer-support programs, and mental-health primary consumer- directed programs); and
p.001299: (2) services under the plan will be provided through com- munity mental health centers only if the centers
p.001299: meet the cri- teria specified in subsection (c).
p.001299: (c) CRITERIA FOR MENTAL HEALTH CENTERS.—The criteria re- ferred to in subsection (b)(2) regarding
p.001299: community mental health centers are as follows:
p.001299: (1) With respect to mental health services, the centers pro- vide services as follows:
p.001299: (A) Services principally to individuals residing in a de- fined geographic area (hereafter in this subsection referred
p.001299: to as a ‘‘service area’’).
p.001299: (B) Outpatient services, including specialized out- patient services for children, the elderly,
p.001299: individuals with a serious mental illness, and residents of the service areas of the centers who have been
p.001299: discharged from inpatient treatment at a mental health facility.
p.001299:
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p.001299: January 30, 2020
p.001299: 2 So in law. See section 201 of Public Law 102–321 (106 Stat. 381). Probably should be ‘‘dis-
p.001299: turbance’’.
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001301: 1301
p.001301: PUBLIC HEALTH SERVICE ACT
p.001301: Sec. 1914
p.001301:
p.001301: (C) 24-hour-a-day emergency care services.
p.001301: (D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services.
p.001301: (E) Screening for patients being considered for admis- sion to State mental health facilities to determine the
p.001301: ap- propriateness of such admission.
p.001301: (2) The mental health services of the centers are provided, within the limits of the capacities of the centers,
p.001301: to any indi- vidual residing or employed in the service area of the center regardless of ability to pay
p.001301: for such services.
p.001301: (3) The mental health services of the centers are available and accessible promptly, as appropriate and in a manner
p.001301: which preserves human dignity and assures continuity and high qual- ity care.
p.001301: SEC. 1914. ø300x–3¿ STATE MENTAL HEALTH PLANNING COUNCIL.
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p.000017: and consult with the Depart- ments of Commerce and Labor and any other interested Federal departments or
p.000017: agencies and with State and local health depart- ments and agencies. For such purpose he shall utilize
p.000017: insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to
p.000017: section 3709 of the Revised Stat- utes (41 U.S.C. 5), of any appropriate State or other public agency, and may,
p.000017: without regard to such section, utilize the services or fa- cilities of any private agency, organization, group, or
p.000017: individual, in accordance with written agreements between the head of such agency, organization, or group
p.000017: and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities
p.000017: shall be made in such amounts as may be provided in such agreement.
p.000017: (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health
p.000017: data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation
p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
p.000017: necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data
p.000017: on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific
p.000017: Islanders with significant representation in the State or registration area. Each State or registration area shall
p.000017: be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and
p.000017: transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such
p.000017: data.
p.000017: (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general
p.000017: health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to
p.000017: be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and
p.000017: accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations,
p.000017: and the relationship between de- mographic and socioeconomic characteristics and health character- istics.
p.000017: (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use
p.000017: in such activities of statistics collected or compiled by the Center.
p.000017: (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section,
p.000017: the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and
p.000017: Human Services by—
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p.000017: (D) shall be responsible generally for advising the Sec- retary and the Congress on the status of the
p.000017: implementation of part C of title XI of the Social Security Act.
p.000017: (6) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek
p.000017: the advice of, the Com- mittee and other appropriate professional advisory groups.
p.000017: (7) Not later than 1 year after the date of the enactment of the Health Insurance Portability and Accountability
p.000017: Act of 1996, and annually thereafter, the Committee shall submit to the Congress, and make public, a report
p.000017: regarding the implementation of part C of title XI of the Social Security Act. Such report shall address the following
p.000017: subjects, to the extent that the Committee determines ap- propriate:
p.000017: (A) The extent to which persons required to comply with part C of title XI of the Social Security Act are
p.000017: cooperating in implementing the standards adopted under such part.
p.000017: (B) The extent to which such entities are meeting the secu- rity standards adopted under such part and the
p.000017: types of pen- alties assessed for noncompliance with such standards.
p.000017: (C) Whether the Federal and State Governments are re- ceiving information of sufficient quality to meet
p.000017: their respon- sibilities under such part.
p.000017: (D) Any problems that exist with respect to implementa- tion of such part.
p.000017: (E) The extent to which timetables under such part are being met.
p.000017: (l) In carrying out this section, the Secretary, acting through the Center, shall collect and analyze
p.000017: adequate health data that is specific to particular ethnic and racial populations, including data collected
p.000017: under national health surveys. Activities carried out under this subsection shall be in addition
p.000017: to any activities carried out under subsection (m).
p.000017: (m)(1) The Secretary, acting through the Center, may make grants to public and nonprofit private entities for—
p.000017: (A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations;
p.000017: (B) analysis of data on ethnic and racial populations and subpopulations; and
p.000017: (C) research on improving methods for developing statis- tics on ethnic and racial populations and
p.000017: subpopulations.
p.000017: (2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to
p.000017: grantees sup- ported by this subsection in order to maximize the data quality and comparability with other studies.
p.000017: (3) Provisions of section 308(d) do not apply to surveys or stud- ies conducted by grantees under this subsection
p.000017: unless the Sec- retary, in accordance with regulations the Secretary may issue, de- termines that such provisions
p.000017: are necessary for the conduct of the survey or study and receives adequate assurance that the grantee
p.000017: will enforce such provisions.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 85 PUBLIC HEALTH SERVICE ACT Sec. 307
p.000017:
p.000017: (4)(A) Subject to subparagraph (B), the Secretary, acting through the Center, shall collect data on
p.000017: Hispanics and major His- panic subpopulation groups and American Indians, and for devel- oping special area
p.000017: population studies on major Asian American and Pacific Islander populations.
p.000017: (B) The provisions of subparagraph (A) shall be effective with respect to a fiscal year only to the
p.000017: extent that funds are appro- priated pursuant to paragraph (3) of subsection (n), and only if the amounts
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p.000017: professional education, services, and treatment;
p.000017: (2) establish short-range and long-range goals and objec- tives within the Centers for women’s health
p.000017: and, as relevant and appropriate, coordinate with other appropriate offices on activities within the
p.000017: Centers that relate to prevention, re- search, education and training, service delivery, and policy de- velopment,
p.000017: for issues of particular concern to women;
p.000017: (3) identify projects in women’s health that should be con- ducted or supported by the Centers;
p.000017: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.000017: profes- sionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to
p.000017: women; and
p.000017: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.000017: Health (established under section 229(b)(4)).
p.000017: (c) DEFINITION.—As used in this section, the term ‘‘women’s health conditions’’, with respect to women of all
p.000017: age, ethnic, and ra- cial groups, means diseases, disorders, and conditions—
p.000017: (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and
p.000017: (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there
p.000017: is rea- sonable evidence that indicates that such factors or types may be different for women.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 311 PUBLIC HEALTH SERVICE ACT 90
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000017: PART B—FEDERAL-STATE COOPERATION
p.000017: IN GENERAL
p.000017: SEC. 311. ø243¿ (a) The Secretary is authorized to accept from State and local authorities any assistance in the
p.000017: enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and
p.000017: willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and
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p.000107:
p.000107: (1) IN GENERAL.—Not later than May 1 of each year, the Secretary shall submit to the Congress a report
p.000107: on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection
p.000107: (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
p.000107: (2) CERTAIN REQUIREMENTS.—Each report under para- graph (1) shall include, in addition to any other
p.000107: information that the Secretary may require, the following information:
p.000107: (A) The number of infants and children screened.
p.000107: (B) Demographic information on the population of in- fants and children screened, including the age and
p.000107: racial or ethnic status of such population.
p.000107: (C) The number of screening sites.
p.000107: (D) A description of the severity of the extent of the blood lead levels of the infants and children
p.000107: screened, ex- pressed in categories of severity.
p.000107: (E) The sources of payment for the screenings.
p.000107: (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from
p.000107: laboratories and health care providers to State and local health departments.
p.000107: (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if
p.000107: any, provided in the report under paragraph (1) preceding the report involved.
p.000107: (k) INDIAN TRIBES.—For purposes of this section, the term ‘‘po- litical subdivision’’ includes Indian tribes.
p.000107: (l) FUNDING.—
p.000107: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000107: be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years
p.000107: 1994 through 2005.
p.000107: (2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts appropriated under paragraph (1) for any fiscal year,
p.000107: the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities
p.000107: described in subsection (a) in addition to the program of grants established in such sub- section.
p.000107: (m) GUIDELINES FOR STANDARDIZED REPORTING.—The Sec- retary, acting through the Director of the Centers for
p.000107: Disease Con- trol and Prevention, shall develop national guidelines for the uni- form reporting of all
...

p.000109:
p.000109: Sec. 317C PUBLIC HEALTH SERVICE ACT 110
p.000109: of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and
p.000109: Commerce of the House of Representa- tives, a report that summarizes the findings made as a result of such
p.000109: review and that contains the rec- ommendations of the Task Force on the programs and policies with respect to
p.000109: which the Task Force is estab- lished, including related budgetary recommendations; and
p.000109: (vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning
p.000109: prevention activities of the Federal Govern- ment.
p.000109: (b) TECHNOLOGY ASSESSMENT AND EPIDEMIOLOGY.—The Sec- retary, acting through the Director of the Centers for
p.000109: Disease Con- trol and Prevention, shall, directly or through grants or contracts—
p.000109: (1) provide for the development of improved, more cost-ef- fective testing measures for detecting lead toxicity
p.000109: in children;
p.000109: (2) provide for the development of improved methods of as- sessing the prevalence of lead poisoning, including such
p.000109: meth- ods as may be necessary to conduct individual assessments for each State;
p.000109: (3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and
p.000109: children, on the de- mographic characteristics of infants and children with such poisoning (including racial
p.000109: and ethnic status), and on the source of payment for treatment for such poisoning (including the
p.000109: extent to which insurance has paid for such treatment); and
p.000109: (4) provide for any applied research necessary to improve the effectiveness of programs for the
p.000109: prevention of lead poi- soning in infants and children.
p.000109: NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES
p.000109: SEC. 317C. ø247b–4¿ (a) IN GENERAL.—
p.000109: (1) NATIONAL CENTER.—There is established within the Centers for Disease Control and Prevention a center
p.000109: to be known as the National Center on Birth Defects and Develop- mental Disabilities (referred to in this
p.000109: section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease
p.000109: Control and Prevention.
p.000109: (2) GENERAL DUTIES.—The Secretary shall carry out pro- grams—
p.000109:
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p.000109: January 30, 2020
p.000109: (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and
p.000109: disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the
p.000109: causes of such de- fects and disabilities and on the incidence and prevalence of such defects and disabilities;
p.000109: (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention
p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000109:
p.000109:
p.000109:
p.000109:
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p.000111: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000111: pay- ments under the award involved by an amount equal to the costs of detailing personnel and the
p.000111: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall,
p.000111: for the payment of ex- penses incurred in complying with such request, expend the amounts withheld.
p.000111: (3) APPLICATION FOR AWARD.—The Secretary may make an award of a grant or contract under paragraph (1) only if an ap-
p.000111: plication for the award is submitted to the Secretary and the application is in such form, is made in such
p.000111: manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to
p.000111: carry out the purposes for which the award is to be made.
p.000111: (c) BIENNIAL REPORT.—Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the
p.000111: Secretary shall submit to the Committee on Commerce of the House of Representa- tives, and the Committee on Labor
p.000111: and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
p.000111: (1) contains information regarding the incidence and prev- alence of birth defects, developmental
p.000111: disabilities, and the health status of individuals with disabilities and the extent to which these conditions
p.000111: have contributed to the incidence and prevalence of infant mortality and affected quality of life;
p.000111: (2) contains information under paragraph (1) that is spe- cific to various racial and ethnic groups
p.000111: (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
p.000111: (3) contains an assessment of the extent to which various approaches of preventing birth defects,
p.000111: developmental disabil- ities, and secondary health conditions among individuals with disabilities have been
p.000111: effective;
p.000111: (4) describes the activities carried out under this section;
p.000111: (5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or
p.000111: develop- mental disabilities, information on the health status of individ- uals with disabilities, information on any
p.000111: health disparities ex- perienced by such individuals, and recommendations for im- proving the health and
p.000111: wellness and quality of life of such indi- viduals;
p.000111: (6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Dis-
p.000111: ease Control and Prevention, including conferences related to spina bifida; and
p.000111: (7) contains any recommendations of the Secretary regard- ing this section.
p.000111: (d) APPLICABILITY OF PRIVACY LAWS.—The provisions of this section shall be subject to the requirements of
p.000111: section 552a of title 5, United States Code. All Federal laws relating to the privacy of information shall
p.000111: apply to the data and information that is col- lected under this section.
p.000111: (e) ADVISORY COMMITTEE.—Notwithstanding any other provi- sion of law, the members of the advisory
p.000111: committee appointed by
p.000111: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000111:
p.000111:
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p.000459: (2) the information provided to the maternal donor regard- ing all of her medically appropriate cord blood options.
p.000459: Based on such examination, the Secretary shall require that the standards used by the accreditation entities
p.000459: recognized under sub- section (b) ensure that a cord blood unit is acquired with the in- formed consent of
p.000459: the maternal donor.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000459: Sec. 379 PUBLIC HEALTH SERVICE ACT 460
p.000459:
p.000459: (d) FUNCTIONS.— 84
p.000459: (1) BONE MARROW FUNCTIONS.—With respect to bone mar- row, the Program shall—
p.000459: (A) operate a system for identifying, matching, and fa- cilitating the distribution of bone marrow that is
p.000459: suitably matched to candidate patients;
p.000459: (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care
p.000459: professionals, and patients to search by means of electronic access all available bone marrow donors listed in
p.000459: the Program;
p.000459: (C) carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including
p.000459: with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed
p.000459: ances- try) in the enrollment of the Program;
p.000459: (D) maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000459: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000459: January 30, 2020
p.000459:
p.000459: ‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
p.000459: ‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller General of the
p.000459: United States shall conduct a study of the National Bone Marrow Donor Registry under section 379 of the Public
...

p.000463: with the Pro- gram. In the case of populations that are identified under the preceding sentence:
p.000463: (A) The Program shall give priority to carrying out ac- tivities under this part to increase representation for such
p.000463: populations in order to enable a member of such a popu-
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000463: Sec. 379 PUBLIC HEALTH SERVICE ACT 464
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p.000463: lation, to the extent practicable, to have a probability of finding a suitable unrelated donor that is
p.000463: comparable to the probability that an individual who is not a member of an underrepresented population would have.
p.000463: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000463: to be populations that have been identified for purposes of this paragraph, and shall carry out
p.000463: subparagraph (A) with re- spect to such populations.
p.000463: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND ENROLLMENT.—
p.000463: (A) IN GENERAL.—The Program shall carry out infor- mational and educational activities, in coordination
p.000463: with organ donation public awareness campaigns operated through the Department of Health and Human
p.000463: Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll
p.000463: with the Program potential bone marrow donors. Such information and edu- cational activities shall include the
p.000463: following:
p.000463: (i) Making information available to the general public, including information describing the needs of
p.000463: patients with respect to donors of bone marrow.
p.000463: (ii) Educating and providing information to indi- viduals who are willing to serve as potential bone mar- row
p.000463: donors.
p.000463: (iii) Training individuals in requesting individuals to serve as potential bone marrow donors.
p.000463: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000463: Pro- gram shall give priority to recruiting individuals to serve as donors of bone marrow for populations
p.000463: that are identi- fied under paragraph (1).
p.000463: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
...

p.000465: (A) require the establishment of a system of strict con- fidentiality to protect the identity and privacy of
p.000465: patients and donors in accordance with Federal and State law; and
p.000465: (B) prescribe the purposes for which the records de- scribed in subparagraph (A) may be disclosed, and the cir-
p.000465: cumstances and extent of the disclosure; and
p.000465: (6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure
p.000465: the establishment of a method for integrating donor files, searches, and general procedures of the center or
p.000465: registry with the Pro- gram.
p.000465: (g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
p.000465: EDUCATION.—
p.000465: (1) RECRUITMENT; PRIORITIES.—The Program shall support activities, in cooperation with qualified cord blood
p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
p.000465:
p.000465:
p.000465:
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p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000465:
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p.000465: Sec. 379 PUBLIC HEALTH SERVICE ACT 466
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p.000551: (k) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000551: $5,000,000 for each of fiscal years 2018 through 2022.
p.000551: SEC. 399T. ø280g–8¿ SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR
p.000551: POSTNATALLY DIAGNOSED CONDITIONS.
p.000551: (a) DEFINITIONS.—In this section:
p.000551: (1) DOWN SYNDROME.—The term ‘‘Down syndrome’’ refers to a chromosomal disorder caused by an error in
p.000551: cell division that results in the presence of an extra whole or partial copy of chromosome 21.
p.000551: (2) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any person or entity required by State or
p.000551: Federal law or regulation to be licensed, registered, or certified to pro- vide health care services, and who is so
p.000551: licensed, registered, or certified.
p.000551: (3) POSTNATALLY DIAGNOSED CONDITION.—The term ‘‘postnatally diagnosed condition’’ means any health
p.000551: condition identified during the 12-month period beginning at birth.
p.000551: (4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘pre- natally diagnosed condition’’ means any fetal health
p.000551: condition identified by prenatal genetic testing or prenatal screening pro- cedures.
p.000551: (5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diag- nostic or screening tests offered to pregnant women
p.000551: seeking routine prenatal care that are administered on a required or recommended basis by a health care
p.000551: provider based on medical history, family background, ethnic background, previous test results, or other risk
p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000551:
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
p.000551:
p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
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p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000591:
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
p.000593:
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p.000593: January 30, 2020
p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
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p.000595: entity with a privately funded wellness pro- gram requests such an evaluation.
p.000595: SEC. 399MM–3. ø280l–3¿ PROHIBITION OF FEDERAL WORKPLACE WELLNESS REQUIREMENTS.
p.000595: Notwithstanding any other provision of this part, any rec- ommendations, data, or assessments carried out
p.000595: under this part shall not be used to mandate requirements for workplace wellness programs.
p.000595:
p.000595: PART V—PROGRAMS RELATING TO BREAST HEALTH AND CANCER
p.000595:
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p.000595: January 30, 2020
p.000595: SEC. 399NN. ø280m¿ YOUNG WOMEN’S BREAST HEALTH AWARENESS AND SUPPORT OF YOUNG WOMEN DIAGNOSED WITH
p.000595: BREAST CANCER.
p.000595: (a) PUBLIC EDUCATION CAMPAIGN.—
p.000595: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000595: shall conduct a national evidence-based education campaign to in- crease awareness of young women’s knowledge
p.000595: regarding—
p.000595: (A) breast health in young women of all racial, ethnic, and cultural backgrounds;
p.000595: (B) breast awareness and good breast health habits;
p.000595: (C) the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk
p.000595: for breast cancer based on familial, racial, ethnic, and cul- tural backgrounds such as Ashkenazi Jewish
p.000595: populations;
p.000595: (D) evidence-based information that would encourage young women and their health care professional to in-
p.000595: crease early detection of breast cancers; and
p.000595: (E) the availability of health information and other re- sources for young women diagnosed with breast cancer.
p.000595: (2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The campaign shall provide evidence-based, age-appropriate
p.000595: mes- sages and materials as developed by the Centers for Disease Control and Prevention and the Advisory
p.000595: Committee estab- lished under paragraph (4).
p.000595: (3) MEDIA CAMPAIGN.—In conducting the education cam- paign under paragraph (1), the Secretary shall award grants
p.000595: to entities to establish national multimedia campaigns oriented to young women that may include advertising through
p.000595: television, radio, print media, billboards, posters, all forms of existing and especially emerging social networking
p.000595: media, other Internet
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000595:
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p.000595: Sec. 399NN PUBLIC HEALTH SERVICE ACT 596
p.000595:
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p.000609: shall delegate to the Associate Director for Prevention the functions of the Director relating to the
p.000609: promotion of the disease prevention research pro- grams of the national research institutes and the
p.000609: coordination of such programs among the national research institutes and between the national research institutes
p.000609: and other public and private enti- ties, including elementary, secondary, and post-secondary schools. The
p.000609: Associate Director shall—
p.000609: (1) annually review the efficacy of existing policies and techniques used by the national research institutes
p.000609: to dissemi- nate the results of disease prevention and behavioral research programs; and
p.000609: (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to
p.000609: ensure max- imum dissemination, using advanced technologies to the max- imum extent practicable, of research
p.000609: results to such entities. ø(g) Transferred to section 461, redesignated as subsection (b)
p.000609: of such section, and amended (as so redesignated) by section 221(b)(5) of division F of Public Law
p.000609: 112–74.¿
p.000609: (h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of
p.000609: Health, shall, in conducting and supporting programs for research, research training, recruitment, and
p.000609: other activities, provide for an increase in the number of women and individuals from disadvantaged back- grounds
p.000609: (including racial and ethnic minorities) in the fields of bio- medical and behavioral research.
p.000609: (i)(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a
p.000609: data bank of information on clinical trials for drugs for serious or life-threatening diseases
p.000609:
p.000609:
p.000609:
p.000609:
p.000609: January 30, 2020
p.000609: 3 So in law. That Act was repealed by section 251(a)(2) of Public Law 105–220 (112 Stat. 1079).
p.000609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000609: Sec. 402 PUBLIC HEALTH SERVICE ACT 610
p.000609:
p.000609: and conditions (in this subsection referred to as the ‘‘data bank’’). The activities of the data bank shall
p.000609: be integrated and coordinated with related activities of other agencies of the Department of Health and Human
p.000609: Services, and to the extent practicable, coordi- nated with other data banks containing similar information.
p.000609: (B) The Secretary shall establish the data bank after consulta- tion with the Commissioner of Food and Drugs, the
p.000609: directors of the appropriate agencies of the National Institutes of Health (including the National Library of
p.000609: Medicine), and the Director of the Centers for Disease Control and Prevention.
p.000609: (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the
p.000609: information described in such paragraph. The Secretary shall disseminate such information through
...

p.000667: lifespan. The cen- ters, as a group, shall conduct research including the fields of developmental
p.000667: neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral
p.000667: psychology, and clinical psychology.
p.000667: (3) SERVICES FOR PATIENTS.—
p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000667: samples.
p.000667: (d) PUBLIC INPUT.—The Director shall under subsection (a)(1) provide for means through which the public can
...

p.000671: other relevant agencies.
p.000671: (B) DIRECTOR OF NIH.—The Chair of the Committee shall be directly responsible to the Director of NIH.
p.000671: (c) PLAN FOR NIH ACTIVITIES.—
p.000671: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Coordinating
p.000671: Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases
p.000671: through the national research institutes and shall periodically review and revise the plan. The plan shall—
p.000671: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000671: psychosocial, and rehabilitative issues, including studies of the dispropor- tionate impact of such diseases on
p.000671: women;
p.000671: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000671: regarding such diseases; and
p.000671: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000671: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to autoimmune diseases,
p.000671: provide for the following as appropriate:
p.000671: (A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
p.000671: (B) Basic research concerning the etiology and causes of the diseases.
p.000671: (C) Epidemiological studies to address the frequency and natural history of the diseases, including any
p.000671: dif- ferences among the sexes and among racial and ethnic groups.
p.000671: (D) The development of improved screening tech- niques.
p.000671: (E) Clinical research for the development and evalua- tion of new treatments, including new biological agents.
p.000671: (F) Information and education programs for health care professionals and the public.
p.000671: (3) IMPLEMENTATION OF PLAN.—The Director of NIH shall ensure that programs and activities of the National
p.000671: Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph
p.000671: (1).
p.000671: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000671:
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p.000671: Sec. 409F PUBLIC HEALTH SERVICE ACT 672
p.000671:
p.000671:
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p.000671: January 30, 2020
p.000671:
p.000671: MUSCULAR DYSTROPHY RESEARCH
p.000671: SEC. 409F. ø284j¿ (a) COORDINATION OF ACTIVITIES.—The Di-
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p.000705: SEC. 424A. ø285b–7a¿ (a) IN GENERAL.—The Director of the Institute shall expand, intensify, and coordinate
p.000705: research and re- lated activities of the Institute with respect to heart attack, stroke, and other cardiovascular
p.000705: diseases in women.
p.000705: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate activities under
p.000705: subsection (a) with similar activities conducted by the other national research insti- tutes and agencies
p.000705: of the National Institutes of Health to the ex- tent that such Institutes and agencies have
p.000705: responsibilities that are related to heart attack, stroke, and other cardiovascular dis- eases in women.
p.000705: (c) CERTAIN PROGRAMS.—In carrying out subsection (a), the Di- rector of the Institute shall conduct or support research
p.000705: to expand the understanding of the causes of, and to develop methods for pre- venting, cardiovascular diseases in
p.000705: women. Activities under such subsection shall include conducting and supporting the following:
p.000705: (1) Research to determine the reasons underlying the prev- alence of heart attack, stroke, and other
p.000705: cardiovascular dis- eases in women, including African-American women and other women who are members of racial
p.000705: or ethnic minority groups.
p.000705: (2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
p.000705: (3) Epidemiological studies to address the frequency and natural history of such diseases and the
p.000705: differences among men and women, and among racial and ethnic groups, with re- spect to such diseases.
p.000705: (4) The development of safe, efficient, and cost-effective di- agnostic approaches to evaluating women with
p.000705: suspected ischemic heart disease.
p.000705: (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
p.000705: (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women,
p.000705: including appli- cations of effective methods for the control of blood pressure, lipids, and obesity.
p.000705: (7) Information and education programs for patients and health care providers on risk factors associated
p.000705: with heart at- tack, stroke, and other cardiovascular diseases in women, and on the importance of the
p.000705: prevention or control of such risk fac-
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
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p.000705: Sec. 424B PUBLIC HEALTH SERVICE ACT 706
p.000705:
p.000705: tors and timely referral with appropriate diagnosis and treat- ment. Such programs shall include
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p.000719: Sec. 441A PUBLIC HEALTH SERVICE ACT 720
p.000719:
p.000719: LUPUS
p.000719: SEC. 441A. ø285d–6a¿ (a) IN GENERAL.—The Director of the Institute shall expand and intensify research and
p.000719: related activities of the Institute with respect to lupus.
p.000719: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000719: the Director under subsection (a) with similar activities conducted by the other na- tional research
p.000719: institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000719: respon- sibilities that are related to lupus.
p.000719: (c) PROGRAMS FOR LUPUS.—In carrying out subsection (a), the Director of the Institute shall conduct or
p.000719: support research to ex- pand the understanding of the causes of, and to find a cure for, lupus.
p.000719: Activities under such subsection shall include conducting and supporting the following:
p.000719: (1) Research to determine the reasons underlying the ele- vated prevalence of lupus in women, including
p.000719: African-Amer- ican women.
p.000719: (2) Basic research concerning the etiology and causes of the disease.
p.000719: (3) Epidemiological studies to address the frequency and natural history of the disease and the
p.000719: differences among the sexes and among racial and ethnic groups with respect to the disease.
p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
p.000719:
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
...

p.000727: (d) In order to receive a grant or contract under this section, an organization shall submit an
p.000727: application to the Director of the Institute. Such application shall contain—
p.000727: (1) information demonstrating that such organization has a network of contacts which will enable such
p.000727: organization to receive information necessary to the operation of the central computerized information system
p.000727: described in subsection (b)(1);
p.000727: (2) information demonstrating that, by the end of fiscal year 1991, such organization will be financially
p.000727: able to, and will, carry out the activities described in subsection (b) without a grant or contract from the Federal
p.000727: Government; and
p.000727: (3) such other information as the Director may prescribe.
p.000727: ALZHEIMER’S DISEASE REGISTRY
p.000727: SEC. 445G. ø285e–9¿ (a) IN GENERAL.—The Director of the In- stitute may make a grant to develop a registry for the
p.000727: collection of epidemiological data about Alzheimer’s disease and its incidence in the United States, to train personnel
p.000727: in the collection of such data, and for other matters respecting such disease.
p.000727: (b) QUALIFICATIONS.—To qualify for a grant under subsection
p.000727: (a) an applicant shall—
p.000727: (1) be an accredited school of medicine or public health which has expertise in the collection of
p.000727: epidemiological data about individuals with Alzheimer’s disease and in the develop- ment of disease registries, and
p.000727: (2) have access to a large patient population, including a patient population representative of
p.000727: diverse ethnic back- grounds.
p.000727:
p.000727: January 30, 2020 As Amended Through P.L. 116-94,
p.000727: Enacted December 20, 2019
p.000727:
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p.000727: Sec. 445H PUBLIC HEALTH SERVICE ACT 728
p.000727:
p.000727: AGING PROCESSES REGARDING WOMEN
p.000727: SEC. 445H. ø285e–10¿ The Director of the Institute, in addition to other special functions specified in section
p.000727: 444 and in coopera- tion with the Directors of the other national research institutes and agencies of the
p.000727: National Institutes of Health, shall conduct re- search into the aging processes of women, with particular
p.000727: emphasis given to the effects of menopause and the physiological and behav- ioral changes occurring during the
p.000727: transition from pre- to post- menopause, and into the diagnosis, disorders, and complications re- lated to aging
p.000727: and loss of ovarian hormones in women.
p.000727: SEC. 445I. ø285e–10a¿ ALZHEIMER’S CLINICAL RESEARCH AND TRAIN- ING AWARDS.
p.000727: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
p.000727: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000727: treatment of individuals with Alz- heimer’s disease.
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p.000733: commence a study for the purpose of providing information on the general health and well-being of
p.000733: adolescents in the United States, including, with re- spect to such adolescents, information on—
p.000733: (1) the behaviors that promote health and the behaviors that are detrimental to health; and
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000733:
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p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
p.000735: monitor the sub- jects throughout the period of the study to determine the health status of the
p.000735: subjects and any change in such status over time.
p.000735: (2) POPULATION-SPECIFIC ANALYSES.—The study required in subsection (a) shall be conducted with respect to
p.000735: the popu- lation of adolescents who are female, the population of adoles- cents who are male, various
p.000735: socioeconomic populations of ado- lescents, and various racial and ethnic populations of adoles- cents. The
p.000735: study shall be designed and conducted in a manner sufficient to provide for a valid analysis of whether there
p.000735: are significant differences among such populations in health status and whether and to what extent any such
p.000735: differences are due to factors particular to the populations involved.
p.000735: (c) COORDINATION WITH WOMEN’S HEALTH INITIATIVE.—With respect to the national study of women being conducted
p.000735: by the Sec- retary and known as the Women’s Health Initiative, the Secretary shall ensure that such study is
p.000735: coordinated with the component of the study required in subsection (a) that concerns adolescent fe- males,
p.000735: including coordination in the design of the 2 studies.
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p.000735: January 30, 2020
p.000735: FRAGILE X
p.000735: SEC. 452E. ø285g–9¿ (a) EXPANSION AND COORDINATION OF RE-
p.000735: SEARCH ACTIVITIES.—The Director of the Institute, after consulta- tion with the advisory council for the
p.000735: Institute, shall expand, inten- sify, and coordinate the activities of the Institute with respect to research
p.000735: on the disease known as fragile X.
p.000735: (b) RESEARCH CENTERS.—
p.000735: (1) IN GENERAL.—The Director of the Institute shall make grants or enter into contracts for the development and
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p.000785: (c) COORDINATING COMMITTEE.—
p.000785: (1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the
p.000785: Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘‘Coordinating
p.000785: Committee’’).
p.000785: (2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the
p.000785: senior-level staff designees of the Directors).
p.000785: (3) The Director of the Office shall serve as the chair of the Coordinating Committee.
p.000785: (4) With respect to research on women’s health, the Co- ordinating Committee shall assist the Director
p.000785: of the Office in—
p.000785:
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p.000785: January 30, 2020
p.000785: (A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to
p.000785: ade- quately support the research;
p.000785: (B) identifying needs regarding the coordination of re- search activities, including intramural and
p.000785: extramural multidisciplinary activities;
p.000785: (C) supporting the development of methodologies to determine the circumstances in which obtaining data
p.000785: spe- cific to women (including data relating to the age of women and the membership of women in
p.000785: ethnic or racial
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000787: PUBLIC HEALTH SERVICE ACT
p.000787: Sec. 486
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p.000787: January 30, 2020
p.000787: groups) is an appropriate function of clinical trials of treat- ments and therapies;
p.000787: (D) supporting the development and expansion of clin- ical trials of treatments and therapies for which obtaining such
p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
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p.000787: January 30, 2020
p.000787:
p.000787: (iii) the level of funding needed for such research.
p.000787: (B) The report required in subparagraph (A) shall be sub- mitted to the Director of NIH for inclusion
p.000787: in the report re- quired in section 403.
p.000787: (e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The Secretary, acting through the Assistant Secretary for
p.000787: Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are
p.000787: represented among senior physi- cians and scientists of the national research institutes and among
p.000787: physicians and scientists conducting research with funds provided by such institutes, and as appropriate,
p.000787: carry out activities to in- crease the extent of such representation.
p.000787: (f) DEFINITIONS.—For purposes of this part:
p.000787: (1) The term ‘‘women’s health conditions’’, with respect to women of all age, ethnic, and racial groups, means
p.000787: all diseases, disorders, and conditions (including with respect to mental health)—
p.000787: (A) unique to, more serious, or more prevalent in women;
p.000787: (B) for which the factors of medical risk or types of medical intervention are different for women, or for
p.000787: which it is unknown whether such factors or types are different for women; or
p.000787: (C) with respect to which there has been insufficient clinical research involving women as subjects or
p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
...

p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
p.000789: (C) provide contracts for scholarships and loan repayments in accordance with sections 487D and 487E, subject
p.000789: to pro- viding not more than an aggregate 50 such contracts during the fiscal years 1994 through 1996.
p.000789: A reference in this subsection to the National Institutes of Health shall be considered to include the
p.000789: institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the
p.000789: Administration, 53 as the case may be.
p.000789: (2) Ruth L. Kirschstein National Research Service Awards may not be used to support residency training of
p.000789: physicians and other health professionals.
p.000789: (3) In awarding Ruth L. Kirschstein National Research Service Awards under this section, the Secretary shall take
p.000789: account of the Nation’s overall need for biomedical research personnel by giving special consideration to
p.000789: physicians who agree to undertake a min- imum of two years of biomedical research.
p.000789: (4) The Secretary shall carry out paragraph (1) in a manner that will result in the recruitment of women, and
p.000789: individuals from disadvantaged backgrounds (including racial and ethnic minori- ties), into fields of
p.000789: biomedical or behavioral research and in the provision of research training to women and such individuals.
p.000789: (b)(1) No Ruth L. Kirschstein National Research Service Award may be made by the Secretary to any individual unless—
p.000789: (A) the individual has submitted to the Secretary an appli- cation therefor and the Secretary has approved the
p.000789: application;
p.000789: (B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe,
p.000789: assurances satis- factory to the Secretary that the individual will meet the serv- ice requirement of subsection (c);
p.000789: and
p.000789: (C) in the case of a Ruth L. Kirschstein National Research Service Award for a purpose described in
p.000789: subsection (a)(1)(A)(iii), the individual has been sponsored (in such man- ner as the Secretary may by
p.000789: regulation require) by the institu- tion at which the research or training under the award will be conducted.
p.000789: An application for an award shall be in such form, submitted in such manner, and contain such
p.000789: information, as the Secretary may by regulation prescribe.
p.000789: (2) The making of grants under subsection (a)(1)(B) for Ruth
p.000789: L. Kirschstein National Research Service Awards shall be subject to review and approval by the appropriate
p.000789: advisory councils within the Department of Health and Human Services (A) whose activities relate to the research or
p.000789: training under the awards, or (B) for the entity at which such research or training will be conducted.
p.000789: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000789:
p.000789:
p.000789:
p.000789:
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p.000789:
...

p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
...

p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
...

p.000981: calculating a repayment schedule;
p.000981: (E) offers, in accordance with criteria prescribed by regulation by the Secretary, a schedule for
p.000981: repayment of principal and interest under which payment of a portion of the principal and interest otherwise
p.000981: payable at the begin- ning of the repayment period (as defined in such regula- tions) is deferred until a
p.000981: later time in the period;
p.000981: (F) entitles the borrower to accelerate without penalty repayment of the whole or any part of the loan;
p.000981: (G) provides that the check for the proceeds of the loan shall be made payable jointly to the borrower and the eligi-
p.000981: ble institution in which the borrower is enrolled; and
p.000981: (H) contains such other terms and conditions con- sistent with the provisions of this subpart and with
p.000981: the regulations issued by the Secretary pursuant to this sub- part, as may be agreed upon by the
p.000981: parties to such loan, including, if agreed upon, a provision requiring the bor- rower to pay to the lender,
p.000981: in addition to principal and in- terest, amounts equal to the insurance premiums payable by the lender to
p.000981: the Secretary with respect to such loan; and
p.000981: (3) subject to the consent of the student and subject to ap- plicable law, the eligible lender has obtained from the
p.000981: student appropriate demographic information regarding the student, including racial or ethnic background.
p.000981: (b) LIMITATION ON RATE OF INTEREST.—The rate of interest prescribed and defined by the Secretary for the
p.000981: purpose of sub- section (a)(2)(D) may not exceed the average of the bond equivalent rates of the 91-day Treasury
p.000981: bills auctioned for the previous quar-
p.000981:
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p.000981:
p.000981: January 30, 2020
p.000981: 1 So in law. Probably should include another closing parenthesis.
p.000981: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000981: Sec. 706 PUBLIC HEALTH SERVICE ACT 982
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p.000981: January 30, 2020
p.000981:
p.000981: ter plus 3 percentage points, rounded to the next higher one-eighth of 1 percent.
p.000981: (c) MINIMUM ANNUAL PAYMENT BY BORROWER.—The total of the payments by a borrower during any year or any
p.000981: repayment pe- riod with respect to the aggregate amount of all loans to that bor- rower which are insured under this
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p.001005: 1005
p.001005: PUBLIC HEALTH SERVICE ACT
p.001005: Sec. 724
p.001005:
p.001005: (1) any Federal capital contribution made to the student loan fund of the school from such amounts,
p.001005: together with the school contribution appropriate under subsection (b)(2)(B) of such section to the amount of
p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
p.001005: (2) collections of principal and interest on loans made pur- suant to paragraph (1), and any other earnings of the
p.001005: student loan fund attributable to amounts that are in the fund pursu- ant to such paragraph, will be utilized only for
p.001005: the purpose de- scribed in such paragraph.
p.001005: (b) MINIMUM QUALIFICATIONS FOR SCHOOLS.—The Secretary may not make a Federal capital contribution for
p.001005: purposes of sub- section (a) for a fiscal year unless the health professions school in- volved—
p.001005:
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p.001005: January 30, 2020
p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
p.001005: (2) with respect to health clinics providing services to a significant number of individuals who are
p.001005: from disadvantaged backgrounds, including members of minority groups, to enter into arrangements with 1 or more
p.001005: such clinics for the purpose of providing students of the school with experience in providing clinical services to such
p.001005: individuals;
p.001005: (3) with respect to public or nonprofit private secondary educational institutions and undergraduate
p.001005: institutions of higher education, to enter into arrangements with 1 or more such institutions for the
p.001005: purpose of carrying out programs re- garding the educational preparation of disadvantaged students, including
p.001005: minority students, to enter the health professions and regarding the recruitment of such individuals into
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p.001009: uate from the school, including providing scholarships and other financial assistance to such individuals and
p.001009: encouraging under-represented minority students from all levels of the educational pipeline to pursue health
p.001009: professions careers; and
p.001009: (iv) has made significant recruitment efforts to in- crease the number of under-represented minority indi- viduals
p.001009: serving in faculty or administrative positions at the school.
p.001009: (C) CONSORTIUM.—The condition specified in this sub- paragraph is that, in accordance with subsection (e)(1), the
p.001009: designated health profession school involved has with other health profession schools (designated or
p.001009: otherwise) formed a consortium to carry out the purposes described in subsection (b) at the schools of the consortium.
p.001009: (D) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Secretary
p.001009: for purposes of determining whether schools meet the condi- tions described in subparagraph (B), this section
p.001009: may not,
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
p.001011: (A) CONDITIONS.—The conditions specified in this sub- paragraph are that a designated health professions
p.001011: school—
p.001011: (i) is a school described in section 799B(1); and
p.001011: (ii) received a contract under section 788B for fis- cal year 1987, as such section was in effect for such
p.001011: fiscal year.
p.001011: (B) USE OF GRANT.—In addition to the purposes de- scribed in subsection (b), a grant under subsection
p.001011: (a) to a designated health professions school meeting the condi- tions described in subparagraph (A) may be
p.001011: expended—
p.001011: (i) to develop a plan to achieve institutional im- provements, including financial independence, to en-
p.001011: able the school to support programs of excellence in health professions education for under-represented mi-
p.001011: nority individuals; and
p.001011: (ii) to provide improved access to the library and informational resources of the school.
p.001011: (C) EXCEPTION.—The requirements of paragraph (1)(C) shall not apply to a historically black college or university that
p.001011: receives funding under paragraphs (2) or (5) 7.
p.001011: (3) HISPANIC CENTERS OF EXCELLENCE.—The conditions specified in this paragraph are that—
p.001011: (A) with respect to Hispanic individuals, each of clauses (i) through (iv) of paragraph (1)(B)
p.001011: applies to the designated health professions school involved;
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p.001015: unless the health professions and nursing schools involved agree that, in pro- viding scholarships pursuant to the
p.001015: grant, the schools will give preference to students for whom the costs of attending the schools would constitute
p.001015: a severe financial hardship and, notwithstanding other provisions of this section, to former recipients of
p.001015: scholarships under sections 736 and 740(d)(2)(B) (as such sections existed on the day before the date of enactment of
p.001015: this section).
p.001015: (c) AMOUNT OF AWARD.—In awarding grants to eligible entities that are health professions and nursing schools, the
p.001015: Secretary shall give priority to eligible entities based on the proportion of grad- uating students going
p.001015: into primary care, the proportion of under- represented minority students, and the proportion of graduates
p.001015: working in medically underserved communities.
p.001015: (d) DEFINITIONS.—In this section:
p.001015: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means an entity that—
p.001015: (A) is a school of medicine, osteopathic medicine, den- tistry, nursing (as defined in section 801),
p.001015: pharmacy, podiatric medicine, optometry, veterinary medicine, public health, chiropractic, or allied health,
p.001015: a school offering a graduate program in behavioral and mental health prac- tice, or an entity providing
p.001015: programs for the training of physician assistants; and
p.001015: (B) is carrying out a program for recruiting and retain- ing students from disadvantaged backgrounds, including
p.001015: students who are members of racial and ethnic minority groups.
p.001015: (2) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who—
p.001015: (A) is from a disadvantaged background;
p.001015: (B) has a financial need for a scholarship; and
p.001015: (C) is enrolled (or accepted for enrollment) at an eligi- ble health professions or nursing school as a full-time stu-
p.001015: dent in a program leading to a degree in a health profes- sion or nursing.
p.001015: SEC. 738. ø293b¿ LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY POSITIONS.
p.001015: (a) LOAN REPAYMENTS.—
p.001015: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program of entering into contracts with
p.001015: individuals described in paragraph (2) under which the individuals agree to serve as members of the
p.001015: faculties of schools described in paragraph (3) in consideration of the Federal Government agreeing
p.001015: to pay, for each year of such service, not more than
p.001015: $30,000 of the principal and interest of the educational loans of such individuals.
p.001015: (2) ELIGIBLE INDIVIDUALS.—The individuals referred to in paragraph (1) are individuals from disadvantaged
p.001015: backgrounds who—
p.001015: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001015:
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p.001017: 1017
p.001017: PUBLIC HEALTH SERVICE ACT
p.001017: Sec. 738
p.001017:
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p.001017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001019: PUBLIC HEALTH SERVICE ACT
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p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
p.001019: (B) facilitating the entry of such individuals into such a school;
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p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
p.001019: common objectives with institutions of higher education, school dis- tricts, and other community-based entities.
p.001019: (2) Such formal agreements shall reflect the coordination of educational activities and support services,
p.001019: increased link- ages, and the consolidation of resources within a specific geo- graphic area.
p.001019: (3) The design of the educational activities involved shall provide for the establishment of a
p.001019: competitive health profes- sions applicant pool of individuals from disadvantaged back- grounds by enhancing
p.001019: the total preparation (academic and so- cial) of such individuals to pursue a health professions career.
p.001019: (4) The programs or activities under the award shall focus on developing a culturally competent health care
p.001019: workforce that will serve the unserved and underserved populations within the geographic area.
p.001019: (c) EQUITABLE ALLOCATION OF FINANCIAL ASSISTANCE.—The Secretary, to the extent practicable, shall ensure that
p.001019: services and activities under subsection (a) are adequately allocated among the various racial and ethnic
p.001019: populations who are from disadvantaged backgrounds.
p.001019: (d) MATCHING REQUIREMENTS.—The Secretary may require that an entity that applies for a grant or contract
p.001019: under subsection (a), provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of
p.001019: the entity to the projects funded
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: PUBLIC HEALTH SERVICE ACT
p.001021: Sec. 741
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p.001021: January 30, 2020
p.001021: under the grant or contract. As determined by the Secretary, such non-Federal matching funds may be provided
p.001021: directly or through donations from public or private entities and may be in cash or in- kind, fairly evaluated,
p.001021: including plant, equipment, or services.
p.001021: SEC. 740. ø293d¿ AUTHORIZATION OF APPROPRIATION.
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p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
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p.001060: SEC. 765. ø295¿ GENERAL PROVISIONS.
p.001060: (a) IN GENERAL.—The Secretary may award grants or contracts to eligible entities to increase the number of individuals
p.001060: in the pub- lic health workforce, to enhance the quality of such workforce, and to enhance the ability of the workforce
p.001060: to meet national, State, and local health care needs.
p.001060: (b) ELIGIBILITY.—To be eligible to receive a grant or contract under subsection (a) an entity shall—
p.001060: (1) be—
p.001060: (A) a health professions school, including an accredited school or program of public health, health
p.001060: administration, preventive medicine, or dental public health or a school providing health management programs;
p.001060: (B) an academic health center;
p.001060: (C) a State or local government; or
p.001060: (D) any other appropriate public or private nonprofit entity; and
p.001060: (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such
p.001060: information as the Secretary may require.
p.001060: (c) PREFERENCE.—In awarding grants or contracts under this section the Secretary may grant a preference to
p.001060: entities—
p.001060: (1) serving individuals who are from disadvantaged back- grounds (including underrepresented racial and
p.001060: ethnic minori- ties); and
p.001060: (2) graduating large proportions of individuals who serve in underserved communities.
p.001060: (d) ACTIVITIES.—Amounts provided under a grant or contract awarded under this section may be used for—
p.001060: (1) the costs of planning, developing, or operating dem- onstration training programs;
p.001060: (2) faculty development;
p.001060: (3) trainee support;
p.001060: (4) technical assistance;
p.001060: (5) to meet the costs of projects—
p.001060: (A) to plan and develop new residency training pro- grams and to maintain or improve existing
p.001060: residency training programs in preventive medicine and dental pub- lic health, that have available full-time
p.001060: faculty members with training and experience in the fields of preventive medicine and dental public health;
p.001060: and
p.001060: (B) to provide financial assistance to residency train- ees enrolled in such programs;
p.001060: (6) the retraining of existing public health workers as well as for increasing the supply of new practitioners to
p.001060: address pri- ority public health, preventive medicine, public health den- tistry, and health administration
p.001060: needs;
p.001060: (7) preparing public health professionals for employment at the State and community levels;
p.001060: (8) public health workforce loan repayment programs; or
p.001060: (9) other activities that may produce outcomes that are consistent with the purposes of this section.
p.001060: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001077: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001077: title that relates to the period during which payments may be made under the award.
p.001077: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001077: Sec. 799A PUBLIC HEALTH SERVICE ACT 1078
p.001077:
p.001077: (f) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001077: (1) IN GENERAL.—Each application for a grant under this title, except any scholarship or loan program,
p.001077: including those under sections 23 701, 721, or 723, shall be submitted to a peer review group for an evaluation
p.001077: of the merits of the proposals made in the application. The Secretary may not approve such an
p.001077: application unless a peer review group has recommended the application for approval.
p.001077: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001077: are not officers or employees of the Federal Government. In pro- viding for the establishment of peer
p.001077: review groups and proce- dures, the Secretary shall ensure sex, racial, ethnic, and geo- graphic balance
p.001077: among the membership of such groups.
p.001077: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001077: Administrator of the Health Resources and Services Administration.
p.001077: (g) PREFERENCE OR PRIORITY CONSIDERATIONS.—In considering a preference or priority for funding which is
p.001077: based on outcome measures for an eligible entity under this title, the Secretary may also consider the
p.001077: future ability of the eligible entity to meet the outcome preference or priority through improvements in
p.001077: the eligi- ble entity’s program design.
p.001077: (h) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001077: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001077: analysis activities under section 761; and
p.001077: (2) discipline-specific workforce information and analytical activities are carried out as part of—
p.001077: (A) the community-based linkage program under part D; and
p.001077: (B) the health workforce development program under subpart 2 of part E.
p.001077: (i) OSTEOPATHIC SCHOOLS.—For purposes of this title, any ref- erence to—
p.001077: (1) medical schools shall include osteopathic medical schools; and
p.001077: (2) medical students shall include osteopathic medical stu- dents.
p.001077: SEC. 799A. ø295o–2¿ TECHNICAL ASSISTANCE.
p.001077: Funds appropriated under this title may be used by the Sec- retary to provide technical assistance in
p.001077: relation to any of the au- thorities under this title.
p.001077: SEC. 799B. ø295p¿ DEFINITIONS.
p.001077: For purposes of this title:
p.001077: (1)(A) The terms ‘‘school of medicine’’, ‘‘school of dentistry’’, ‘‘school of osteopathic medicine’’, ‘‘school of
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p.001081: (B) is eligible to be served by a migrant health center under section 329 25, a community health center under sec- tion
p.001081: 330 25, a grantee under section 330(h) (relating to homeless individuals), or a grantee under section
p.001081: 340A 25 (relating to residents of public housing);
p.001081: (C) has a shortage of personal health services, as de- termined under criteria issued by the Secretary under
p.001081: sec- tion 1861(aa)(2) of the Social Security Act (relating to rural health clinics); or
p.001081: (D) is designated by a State Governor (in consultation with the medical community) as a shortage area or medi-
p.001081: cally underserved community.
p.001081: (7) The term ‘‘Department’’ means the Department of Health and Human Services.
p.001081: (8) The term ‘‘nonprofit’’ refers to the status of an entity owned and operated by one or more
p.001081: corporations or associa- tions no part of the net earnings of which inures, or may law- fully inure, to the
p.001081: benefit of any private shareholder or indi- vidual.
p.001081: (9) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.001081: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.001081: American Samoa, and the Trust Territory of the Pacific Islands.
p.001081: (10)(A) Subject to subparagraph (B), the term ‘‘underrep- resented minorities’’ means, with respect to a
p.001081: health profes- sion, racial and ethnic populations that are underrepresented in the health profession
p.001081: relative to the number of individuals who are members of the population involved.
p.001081: (B) For purposes of subparagraph (A), Asian individuals shall be considered by the various subpopulations of
p.001081: such indi- viduals.
p.001081: (11) The term ‘‘psychologist’’ means an individual who—
p.001081: (A) holds a doctoral degree in psychology; and
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p.001081: January 30, 2020
p.001081: 25 The reference in paragraph (6)(B) to section 329 refers to section 329 of the Act of July 1, 1944,
p.001081: which was omitted in the general amendment of subpart I of part D of this title by section 2 of Public Law 104-299
p.001081: (110 Stat. 3626; October 11, 1996). Section 340A, referred to in para- graph (6)(B), was repealed by section
p.001081: 4(a)(3) of Public Law 104-299.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001081: Sec. 799B PUBLIC HEALTH SERVICE ACT 1082
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p.001081: (B) is licensed or certified on the basis of the doctoral degree in psychology, by the State in which the individual
p.001081: practices, at the independent practice level of psychology to furnish diagnostic, assessment, preventive,
p.001081: and thera- peutic services directly to individuals.
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p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
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p.001083: January 30, 2020
p.001083: 26 Effective on July 1, 2015, section 512(z)(3) of Public Law 113–128 provides for an amend- ment to
p.001083: strike ‘‘one-stop delivery system described in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C.
p.001083: 2864(c))’’ and insert ‘‘one-stop delivery system described in section 121(e) of the Workforce Innovation and
p.001083: Opportunity Act’’.
p.001083: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001087: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001087: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001087: title that relates to the period during which payments may be made under the award.
p.001087: (e) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001087: (1) IN GENERAL.—Each application for a grant under this title, except advanced nurse traineeship grants
p.001087: under section 811(a)(2), shall be submitted to a peer review group for an evaluation of the merits of
p.001087: the proposals made in the applica- tion. The Secretary may not approve such an application un- less a
p.001087: peer review group has recommended the application for approval.
p.001087: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001087: are
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p.001087: Sec. 807 PUBLIC HEALTH SERVICE ACT 1088
p.001087:
p.001087: not officers or employees of the Federal Government. In pro- viding for the establishment of peer review
p.001087: groups and proce- dures, the Secretary shall, except as otherwise provided, en- sure sex, racial, ethnic,
p.001087: and geographic representation among the membership of such groups.
p.001087: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001087: Administrator of the Health Resources and Services Administration.
p.001087: (f) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001087: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001087: analysis activities under this title; and
p.001087: (2) discipline-specific workforce information is developed and analytical activities are carried out as part of—
p.001087: (A) the advanced education nursing activities under part B;
p.001087: (B) the workforce diversity activities under part C;
p.001087: and
p.001087: (C) basic nursing education and practice activities
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p.001087: under part D.
p.001087: (g) STATE AND REGIONAL PRIORITIES.—Activities under grants or contracts under this title shall, to the
p.001087: extent practicable, be con- sistent with related Federal, State, or regional nursing professions program plans and
p.001087: priorities.
p.001087: (h) FILING OF APPLICATIONS.—
p.001087: (1) IN GENERAL.—Applications for grants or contracts under this title may be submitted by
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p.001089: other advanced nurse education programs eligible for support under this section.
p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
p.001089: the costs of special projects to increase nursing education opportunities for individuals who are from
p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
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p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
...

p.001273: (e) For the purpose of carrying out this section, there are au- thorized to be appropriated $10,000,000
p.001273: for fiscal year 1992, and such sums as may be necessary for each of the fiscal years 1993 through 2003.
p.001273:
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p.001273: January 30, 2020
p.001273: OFFICE OF MINORITY HEALTH
p.001273: SEC. 1707. ø300u–6¿ (a) IN GENERAL.—There is established an Office of Minority Health. The Office of Minority Health as
p.001273: existing on the date of enactment of the Patient Protection and Affordable Care Act shall be transferred to
p.001273: the Office of the Secretary in such manner that there is established in the Office of the Secretary, the Office of
p.001273: Minority Health, which shall be headed by the Deputy As- sistant Secretary for Minority Health who shall report
p.001273: directly to the Secretary, and shall retain and strengthen authorities (as in existence on such date of
p.001273: enactment) for the purpose of improving minority health and the quality of health care minorities
p.001273: receive, and eliminating racial and ethnic disparities. In carrying out this subsection, the Secretary, acting
p.001273: through the Deputy Assistant Sec- retary, shall award grants, contracts, enter into memoranda of un- derstanding,
p.001273: cooperative, interagency, intra-agency and other agreements with public and nonprofit private entities,
p.001273: agencies, as well as Departmental and Cabinet agencies and organizations, and
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001273:
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p.001273: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1274
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p.001273: January 30, 2020
p.001273:
p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
p.001273: (9) Carry out programs to improve access to health care services for individuals with limited proficiency in
...

p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
p.001275: paragraph (1) during the pre- ceding 2 fiscal years. The report shall be included in the report required under
p.001275: subsection (f) for the fiscal year involved.
p.001275: (f) REPORTS.—
p.001275: (1) IN GENERAL.—Not later than February 1 of fiscal year 1999 and of each second year thereafter, the
p.001275: Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the
p.001275: Committee on Labor and Human Resources of the Senate, a report describing the activi- ties carried out under this
p.001275: section during the preceding 2 fiscal years and evaluating the extent to which such activities have been
p.001275: effective in improving the health of racial and ethnic mi- nority groups. Each such report shall include the
p.001275: biennial re- ports submitted under sections 201(e)(3) and 201(f)(2) for such years by the heads of the Public Health
p.001275: Service agencies.
p.001275: (2) AGENCY REPORTS.—Not later than February 1, 1999, and biennially thereafter, the heads of the Public Health
p.001275: Serv-
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001277: 1277
p.001277: PUBLIC HEALTH SERVICE ACT
p.001277: Sec. 1707A
p.001277:
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p.001277: January 30, 2020
p.001277: ice agencies shall submit to the Deputy Assistant Secretary a report summarizing the minority health
p.001277: activities of each of the respective agencies.
p.001277: (g) DEFINITION.—For purposes of this section:
p.001277: (1) The term ‘‘racial and ethnic minority group’’ means American Indians (including Alaska Natives,
p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
...

p.001277: for the purpose of improving adolescent health, including projects to train health care providers in
p.001277: providing services to adoles- cents and projects to reduce the incidence of violence among adolescents,
p.001277: particularly among minority males.
p.001277: (2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there are authorized to be
p.001277: appro- priated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994
p.001277: through 1997.
p.001277: (d) INFORMATION CLEARINGHOUSE.—In carrying out subsection (b), the Secretary shall establish and maintain a
p.001277: National Informa- tion Clearinghouse on Adolescent Health to collect and disseminate to health professionals and
p.001277: the general public information on ado- lescent health.
p.001277: (e) NATIONAL PLAN.—In carrying out subsection (b), the Sec- retary shall develop a national plan
p.001277: for improving adolescent health. The plan shall be consistent with the applicable objectives established
p.001277: by the Secretary for the health status of the people of the United States for the year 2000, and
p.001277: shall be periodically re- viewed, and as appropriate, revised. The plan, and any revisions in the plan, shall be
p.001277: submitted to the Committee on Energy and Com- merce of the House of Representatives and the Committee on Labor and
p.001277: Human Resources of the Senate.
p.001277: (f) ADOLESCENT HEALTH.—For purposes of this section, the term ‘‘adolescent health’’, with respect to
p.001277: adolescents of all ethnic
p.001277: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001279: 1279
p.001279: PUBLIC HEALTH SERVICE ACT
p.001279: Sec. 1711
p.001279:
p.001279: and racial groups, means all diseases, disorders, and conditions (in- cluding with respect to mental health)—
p.001279: (1) unique to adolescents, or more serious or more preva- lent in adolescents;
p.001279: (2) for which the factors of medical risk or types of medical intervention are different for adolescents, or for which
p.001279: it is un- known whether such factors or types are different for adoles- cents; or
p.001279: (3) with respect to which there has been insufficient clin- ical research involving adolescents as
p.001279: subjects or insufficient clinical data on adolescents.
p.001279: BIENNIAL REPORT REGARDING NUTRITION AND HEALTH
p.001279: SEC. 1709. ø300u–8¿ (a) BIENNIAL REPORT.—The Secretary
p.001279: shall require the Surgeon General of the Public Health Service to prepare biennial reports on the
p.001279: relationship between nutrition and health. Such reports may, with respect to such relationship, include any
p.001279: recommendations of the Secretary and the Surgeon General.
p.001279: (b) SUBMISSION TO CONGRESS.—The Secretary shall ensure that, not later than February 1 of 1995 and
p.001279: of every second year thereafter, a report under subsection (a) is submitted to the Com- mittee on
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p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
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p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
p.001345: prevention services in easily accessible locations. Dem- onstration projects shall, as appropriate,
p.001345: provide, supplement, or improve the quality of such services. Demonstration projects shall use such methods
p.001345: as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of
p.001345: adolescents and to make use of support systems such as other family members, friends, religious and charitable
p.001345: organizations, and voluntary asso- ciations.
p.001345: (b) Grants under this title for demonstration projects may be for the provision of—
p.001345: (1) care services;
p.001345: (2) prevention services; or
p.001345: (3) a combination of care services and prevention services.
p.001345:
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p.001345: January 30, 2020
p.001345:
p.001345: USES OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
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p.001527: 15 So in law. See section 402(b)(2) of Public Law 106–345 (114 Stat. 1349).
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001529: 1529
p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
p.001529:
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001529: Sec. 2693 PUBLIC HEALTH SERVICE ACT 1530
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p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
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p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
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p.001697: January 30, 2020
p.001697:
p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
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p.001699:
p.001699: January 30, 2020
p.001699: 1 So in law. Subsection (b) includes a paragraph (1) but there are no subsequent paragraphs.
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001699:
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p.001699: Sec. 3301 PUBLIC HEALTH SERVICE ACT 1700
p.001699:
p.001699: Accountability Act of 1996 (Public Law 104–191; 110
p.001699: Stat. 2033); and
p.001699: (ii) from all inappropriate internal use by any en- tity that collects, stores, or receives the data, including use of
p.001699: such data in determinations of eligibility (or continued eligibility) in health plans, and from other
p.001699: inappropriate uses, as defined by the Secretary; and
p.001699: (B) all appropriate information security safeguards are used in the collection, analysis, and sharing of data
p.001699: col- lected pursuant to subsection (a).
p.001699: (2) DATA SHARING.—The Secretary shall establish proce- dures for sharing data collected pursuant to
p.001699: subsection (a), measures relating to such data, and analyses of such data, with other relevant Federal
p.001699: and State agencies including the agencies, centers, and entities within the Department of Health and
p.001699: Human Services specified in subsection (c)(1)..
p.001699: (f) DATA ON RURAL UNDERSERVED POPULATIONS.—The Sec- retary shall ensure that any data collected in accordance
p.001699: with this section regarding racial and ethnic minority groups are also col- lected regarding underserved rural
p.001699: and frontier populations.
p.001699: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001699: to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.
p.001699: (h) REQUIREMENT FOR IMPLEMENTATION.—Notwithstanding any other provision of this section, data may not be collected
p.001699: under this section unless funds are directly appropriated for such purpose in an appropriations Act.
p.001699: (i) CONSULTATION.—The Secretary shall consult with the Direc- tor of the Office of Personnel Management, the
p.001699: Secretary of De- fense, the Secretary of Veterans Affairs, the Director of the Bureau of the Census, the
p.001699: Commissioner of Social Security, and the head of other appropriate Federal agencies in carrying out this
p.001699: section.
p.001699: TITLE XXXII—øREPEALED.¿
p.001699:
p.001699: øTitle XXXII of Public Health Service Act was repealed by sec- tion 642(a) of Public Law 112–240.¿
p.001699:
p.001699: TITLE XXXIII—WORLD TRADE CENTER HEALTH PROGRAM
p.001699: Subtitle A—Establishment of Program; Advisory Committee
p.001699:
p.001699:
p.001699:
p.001699:
p.001699:
p.001699:
p.001699:
p.001699: January 30, 2020
p.001699: SEC. 3301. ø42 U.S.C. 300mm¿ ESTABLISHMENT OF WORLD TRADE CEN- TER HEALTH PROGRAM.
p.001699: (a) IN GENERAL.—There is hereby established within the De- partment of Health and Human Services a
p.001699: program to be known as the World Trade Center Health Program, which shall be admin-
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001699:
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p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
...

p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000129:
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p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000499:
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p.000499: Sec. 399A PUBLIC HEALTH SERVICE ACT 500
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p.000499: January 30, 2020
p.000499:
p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
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p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
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p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
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p.000545: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for the
p.000545: purpose of carrying out this section.
p.000545: SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
p.000545: (a) ESTABLISHMENT.—
p.000545: (1) IN GENERAL.—Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary,
p.000545: act- ing through the Director of the Centers for Disease Control and Prevention, may, if scientifically
p.000545: advisable—
p.000545: (A) develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as
p.000545: ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some
p.000545: cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the
p.000545: United States; and
p.000545: (B) establish a national registry for the collection and storage of such data to develop a population-based
p.000545: registry of cases in the United States of ALS and other motor neu- ron disorders that can be confused with ALS,
p.000545: misdiagnosed as ALS, and in some cases progress to ALS.
p.000545: (2) PURPOSE.—It is the purpose of the registry established under paragraph (1)(B) to—
p.000545: (A) better describe the incidence and prevalence of ALS in the United States;
p.000545: (B) examine appropriate factors, such as environ- mental and occupational, that may be associated
p.000545: with the disease;
p.000545: (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history
p.000545: of indi- viduals who are diagnosed with the disease) associated with the disease;
p.000545: (D) better examine the connection between ALS and other motor neuron disorders that can be confused with
p.000545: ALS, misdiagnosed as ALS, and in some cases progress to ALS; and
p.000545: (E) other matters as recommended by the Advisory Committee established under subsection (b).
p.000545: (b) ADVISORY COMMITTEE.—
p.000545: (1) ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the
p.000545: Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a
p.000545: committee to be known as the Ad- visory Committee on the National ALS Registry (referred to in
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000547: Sec. 399S
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p.000549: (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and
p.000549: (2) incorporate information obtained through such activi- ties into an integrated surveillance system, which may
p.000549: consist of or include a registry, to be known as the National Neuro- logical Conditions Surveillance System.
p.000549: (b) RESEARCH.—The Secretary shall ensure that the National Neurological Conditions Surveillance System is
p.000549: designed in a man- ner that facilitates further research on neurological diseases.
p.000549: (c) CONTENT.—In carrying out subsection (a), the Secretary—
p.000549: (1) shall provide for the collection and storage of informa- tion on the incidence and prevalence of
p.000549: neurological diseases in the United States;
p.000549: (2) to the extent practicable, shall provide for the collection and storage of other available information on
p.000549: neurological dis- eases, including information related to persons living with neu- rological diseases who choose to
p.000549: participate, such as—
p.000549: (A) demographics, such as age, race, ethnicity, sex, ge- ographic location, family history, and other information, as
p.000549: appropriate;
p.000549: (B) risk factors that may be associated with neuro- logical diseases, such as genetic and environmental
p.000549: risk factors and other information, as appropriate; and
p.000549: (C) diagnosis and progression markers;
p.000549: (3) may provide for the collection and storage of informa- tion relevant to analysis on neurological
p.000549: diseases, such as in- formation concerning—
p.000549: (A) the natural history of the diseases;
p.000549: (B) the prevention of the diseases;
p.000549: (C) the detection, management, and treatment ap- proaches for the diseases; and
p.000549: (D) the development of outcomes measures;
p.000549: (4) may address issues identified during the consultation process under subsection (d); and
p.000549: (5) initially may address a limited number of neurological diseases.
p.000549: (d) CONSULTATION.—In carrying out this section, the Secretary shall consult with individuals with appropriate
p.000549: expertise, which may include—
p.000549: (1) epidemiologists with experience in disease surveillance or registries;
p.000549: (2) representatives of national voluntary health associa- tions that—
p.000549: (A) focus on neurological diseases; and
p.000549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: Sec. 399V–2 PUBLIC HEALTH SERVICE ACT 560
p.000559:
p.000559: (b) ACTIVITIES.—
p.000559: (1) IN GENERAL.—The Secretary shall carry out activities, including, as appropriate, through a national cohort
p.000559: study and a nationally-representative, population-based surveillance sys- tem, to improve the understanding of the
p.000559: epidemiology of con- genital heart disease in all age groups, with particular atten- tion to—
p.000559: (A) the incidence and prevalence of congenital heart disease in the United States;
p.000559: (B) causation and risk factors associated with, and natural history of, congenital heart disease;
p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000559: January 30, 2020
p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
p.000559: members, and health care providers, on topics such as the prevalence of such disease, the effect of
...

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p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
p.000567: (2) PARTICULAR CANCER.—The term ‘‘particular cancer’’ means one specific type of cancer or a type of cancers
p.000567: scientif- ically proven to have the same cause.
p.000567: (3) POPULATION GROUP.—The term ‘‘population group’’ means a group, for purposes of calculating cancer
p.000567: rates, de- fined by factors such as race, ethnicity, age, or gender.
p.000567: (b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUS-
p.000567: TERS.—
p.000567: (1) DEVELOPMENT OF CRITERIA.—The Secretary shall de- velop criteria for the designation of potential
p.000567: cancer clusters.
p.000567: (2) REQUIREMENTS.—The criteria developed under para- graph (1) shall consider, as appropriate—
p.000567: (A) a standard for cancer cluster identification and re- porting protocols used to determine when cancer incidence is
p.000567: greater than would be typically observed;
p.000567: (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same
p.000567: type of cancer, or types of cancers;
p.000567: (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age,
p.000567: and gender, for purposes of calculating cancer rates;
p.000567: (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create
p.000567: or obscure a potential cluster by selection of a specific area; and
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p.000567: January 30, 2020
p.000567: (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected num- ber
p.000567: of cases, occurs.
p.000567: (c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER CLUSTERS.—The Secretary, in consultation with
p.000567: the Council of State and Territorial Epidemiologists and representatives of State and local health
p.000567: departments, shall develop, publish, and periodi- cally update guidelines for investigating potential cancer
p.000567: clusters. The guidelines shall—
p.000567: (1) recommend that investigations of cancer clusters—
p.000567: (A) use the criteria developed under subsection (b);
p.000567: (B) use the best available science; and
p.000567: (C) rely on a weight of the scientific evidence;
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000569: 569
p.000569: PUBLIC HEALTH SERVICE ACT
p.000569: Sec. 399V–6
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p.000691: Treatment, Ac- cess, and Research Act of 2018, the Secretary shall submit to Congress a report on—
p.000691: (A) the number of biospecimens and corresponding clinical demographic data collected through the biospeci-
p.000691: men research efforts supported under paragraph (1);
p.000691: (B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;
p.000691: (C) barriers to the collection of biospecimens and cor- responding clinical demographic data;
p.000691: (D) barriers experienced by researchers or health care professionals in accessing the biospecimens and cor-
p.000691: responding clinical demographic data necessary for use in research; and
p.000691: (E) recommendations with respect to improving the biospecimen and biorepository research efforts under this
p.000691: subsection.
p.000691: (10) DEFINITIONS.—For purposes of this subsection:
p.000691: (A) AWARD.—The term ‘‘award’’ includes a grant, con- tract, or cooperative agreement determined by the
p.000691: Sec- retary.
p.000691: (B) BIOSPECIMEN.—The term ‘‘biospecimen’’ includes—
p.000691: (i) solid tumor tissue or bone marrow;
p.000691: (ii) normal or control tissue;
p.000691: (iii) blood and plasma;
p.000691: (iv) DNA and RNA extractions;
p.000691: (v) familial DNA; and
p.000691: (vi) any other sample relevant to cancer research, as required by the Secretary.
p.000691: (C) CLINICAL AND DEMOGRAPHIC INFORMATION.—The term ‘‘clinical and demographic information’’ includes—
p.000691: (i) date of diagnosis;
p.000691: (ii) age at diagnosis;
p.000691: (iii) the patient’s sex, race, ethnicity, and environ- mental exposures;
p.000691: (iv) extent of disease at enrollment;
p.000691: (v) site of metastases;
p.000691: (vi) location of primary tumor coded;
p.000691: (vii) histologic diagnosis;
p.000691: (viii) tumor marker data when available;
p.000691: (ix) treatment and outcome data;
p.000691: (x) information related to specimen quality; and
p.000691: (xi) any other applicable information required by the Secretary.
p.000691: (b) IMPROVING CARE FOR PEDIATRIC CANCER SURVIVORS.—
p.000691: (1) RESEARCH ON PEDIATRIC CANCER SURVIVORSHIP.—The Director of NIH, in coordination with ongoing
p.000691: research activi- ties, may continue to conduct or support pediatric cancer survi- vorship research including in any of
p.000691: the following areas:
p.000691: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000693: PUBLIC HEALTH SERVICE ACT
p.000693: Sec. 417F
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p.000787: (C) with respect to which there has been insufficient clinical research involving women as subjects or
p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
p.000787: national research institutes. Information from the data sys- tem shall be available through information systems
p.000787: available to health care professionals and providers, researchers, and members of the public.
p.000787: (2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental
p.000787: treatments that have been developed for research on women’s health. Such registry shall include information on subject
p.000787: eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal
p.000787: investigators of such clinical trials shall provide this information to the registry within 30 days after it is avail-
p.000787: able. Once a trial has been completed, the principal investi- gator shall provide the registry with
p.000787: information pertaining to the results, including potential toxicities or adverse effects as- sociated with the
p.000787: experimental treatment or treatments evalu- ated.
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000787:
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p.000789: PUBLIC HEALTH SERVICE ACT
p.000789: Sec. 487
p.000789:
p.000789: (b) CLEARINGHOUSE.—The Director of NIH, in consultation with the Director of the Office and with
p.000789: the National Library of Medicine, shall establish, maintain, and operate a program to pro- vide information on
p.000789: research and prevention activities of the na- tional research institutes that relate to research on
p.000789: women’s health.
p.000789: SEC. 486B. ø287d–2¿ BIENNIAL REPORT.
p.000789: (a) IN GENERAL.—With respect to research on women’s health, the Director of the Office shall, not later than
p.000789: February 1, 1994, and biennially thereafter, prepare a report—
p.000789: (1) describing and evaluating the progress made during the preceding 2 fiscal years in research and
...

p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000805: PUBLIC HEALTH SERVICE ACT
p.000805: Sec. 493
p.000805:
p.000805: (2) CONTENTS.—Each triennial report prepared by an advi- sory council of each national research institute as described
p.000805: in paragraph (1) shall include each of the following:
p.000805: (A) The number of women included as subjects, and the proportion of subjects that are women, in any
p.000805: project of clinical research conducted during the applicable report- ing period, disaggregated by categories of
p.000805: research area, condition, or disease, and accounting for single-sex studies.
p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
p.000805:
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p.000805: January 30, 2020
p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
p.000805: (1) ESTABLISHMENT OF OFFICE.—Not later than 90 days after the date of enactment of this section, the Secretary
p.000805: shall establish an office to be known as the Office of Research Integ- rity (referred to in this section as the
...

p.001077:
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p.001077:
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p.001077:
p.001077: January 30, 2020
p.001077: SEC. 799. ø295o–1¿ GENERALLY APPLICABLE PROVISIONS.
p.001077: (a) AWARDING OF GRANTS AND CONTRACTS.—The Secretary shall ensure that grants and contracts under this title
p.001077: are awarded on a competitive basis, as appropriate, to carry out innovative dem- onstration projects or provide for
p.001077: strategic workforce supplemen- tation activities as needed to meet health workforce goals and in
p.001077: accordance with this title. Contracts may be entered into under this title with public or private entities as
p.001077: may be necessary.
p.001077: (b) ELIGIBLE ENTITIES.—Unless specifically required otherwise in this title, the Secretary shall accept
p.001077: applications for grants or contracts under this title from health professions schools, academic health centers,
p.001077: State or local governments, or other appropriate public or private nonprofit entities for funding and
p.001077: participation in health professions and nursing training activities. The Secretary may accept applications
p.001077: from for-profit private entities if deter- mined appropriate by the Secretary.
p.001077: (c) INFORMATION REQUIREMENTS.—
p.001077: (1) IN GENERAL.—Recipients of grants and contracts under this title shall meet information requirements as
p.001077: specified by the Secretary.
p.001077: (2) DATA COLLECTION.—The Secretary shall establish pro- cedures to ensure that, with respect to any data
p.001077: collection re- quired under this title, such data is collected in a manner that takes into account age, sex, race, and
p.001077: ethnicity.
p.001077: (3) USE OF FUNDS.—The Secretary shall establish proce- dures to permit the use of amounts appropriated
p.001077: under this title to be used for data collection purposes.
p.001077: (4) EVALUATIONS.—The Secretary shall establish proce- dures to ensure the annual evaluation of
p.001077: programs and projects operated by recipients of grants or contracts under this title. Such procedures shall
p.001077: ensure that continued funding for such programs and projects will be conditioned upon a dem- onstration
p.001077: that satisfactory progress has been made by the pro- gram or project in meeting the objectives of the program
p.001077: or project.
p.001077: (d) TRAINING PROGRAMS.—Training programs conducted with amounts received under this title shall meet
p.001077: applicable accredita- tion and quality standards.
p.001077: (e) DURATION OF ASSISTANCE.—
p.001077: (1) IN GENERAL.—Subject to paragraph (2), in the case of an award to an entity of a grant, cooperative
p.001077: agreement, or contract under this title, the period during which payments are made to the entity under the
p.001077: award may not exceed 5 years. The provision of payments under the award shall be subject to annual approval by the
p.001077: Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the
p.001077: payments. This paragraph may not be construed as limiting the number of awards under the program involved that
p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001077: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
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p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001665:
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p.001697:
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p.001697: January 30, 2020
p.001697: SEC. 3101. ø300kk¿ DATA COLLECTION, ANALYSIS, AND QUALITY.
p.001697: (a) DATA COLLECTION.—
p.001697: (1) IN GENERAL.—The Secretary shall ensure that, by not later than 2 years after the date of enactment of this
p.001697: title, any federally conducted or supported health care or public health program, activity or survey (including
p.001697: Current Population Sur- veys and American Community Surveys conducted by the Bu-
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001697:
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p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
p.001697:
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p.001697: January 30, 2020
p.001697:
p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001697:
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p.001699: 1699
p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
p.001699:
p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
p.001699: activity, the Secretary shall analyze data collected under paragraph (a) to detect and monitor trends in
p.001699: health disparities (as defined for purposes of section 485E) at the Federal and State levels.
p.001699: (c) DATA REPORTING AND DISSEMINATION.—
p.001699: (1) IN GENERAL.—The Secretary shall make the analyses described in (b) available to—
p.001699: (A) the Office of Minority Health;
p.001699: (B) the National Center on Minority Health and Health Disparities;
p.001699: (C) the Agency for Healthcare Research and Quality;
p.001699: (D) the Centers for Disease Control and Prevention;
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p.000445: standards to be a qualified organ procurement organization through a process that either—
p.000445: (i) granted certification or recertification within such 4-year period with such certification or recertification
p.000445: in ef- fect as of January 1, 2000, and remaining in effect through the earlier of—
p.000445: (I) January 1, 2002; or
p.000445: (II) the completion of recertification under the re- quirements of clause (ii); or
p.000445: (ii) is defined through regulations that are promul- gated by the Secretary by not later than January 1, 2002,
p.000445: that—
p.000445: (I) require recertifications of qualified organ pro- curement organizations not more frequently than once every 4
p.000445: years;
p.000445:
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p.000445:
p.000445: January 30, 2020
p.000445: SEC. 301. (a) It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer
p.000445: any human organ for valuable consideration for use in human transplantaion if the transfer affects
p.000445: interstate commerce.
p.000445: (b) Any person who violates subsection (a) shall be fined not more than $50,000 or imprisoned not more than five years,
p.000445: or both.
p.000445: (c) For purposes of subsection (a):
p.000445: (1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow,
p.000445: cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof,
p.000445: including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
p.000445: (2) The term ‘‘valuable consideration’’ does not include the reasonable payments associ- ated with the
p.000445: removal, transportation, implantation, processing, preservation, quality con- trol, and storage of a human
p.000445: organ or the expenses of travel, housing, and lost wages in- curred by the donor of a human organ in
p.000445: connection with the donation of the organ.
p.000445: (3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 201(b) of the Federal
p.000445: Food, Drug and Cosmetic Act.
p.000445: 76 So in law. Subparagraphs (D) and (E) have the same text, and there are two subparagraphs (H). This results from the
p.000445: same set of amendments to section 371(b)(1) being enacted twice. The first set of amendments was made by section
p.000445: 701(c) of Public Law 106–505 (114 Stat. 2347). These amendments redesignated subparagraphs (D) through (G) as
p.000445: subparagraphs (E) through (H), respectively, and then added a new subparagraph (D). The second set was made by section
p.000445: 219(b) of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000445: Appropriations Act, 2001 (as enacted into law by section 1(a)(1) of Public Law 106– 554; 114 Stat.
p.000445: 2763A–29). Per the second set of amendments, the subparagraph (D) added by the first set was
p.000445: redesignated as (E), and the same text was again added as a subparagraph (D). Per the second set,
p.000445: subparagraphs (F) and (G), as redesignated by the first set, were redes- ignated as (G) and (H), which resulted in
p.000445: there being two subparagraphs (H).
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p.000811: PUBLIC HEALTH SERVICE ACT
p.000811: Sec. 498A
p.000811:
p.000811: title establishes express authority for such purpose and unless the Act making appropriations under such provision
p.000811: specifies that the amounts appropriated are available for such purpose.
p.000811: (2) Any grants, cooperative agreements, or contracts authorized in this title for the construction of facilities
p.000811: may be awarded only on a competitive basis.
p.000811: GIFTS
p.000811:
p.000811: SEC. 497. ø289f¿ The Secretary may, in accordance with sec- tion 231, accept conditional gifts for the
p.000811: National Institutes of Health or a national research institute or for the acquisition of grounds or for the
p.000811: erection, equipment, or maintenance of facilities for the National Institutes of Health or a national research
p.000811: insti- tute. Donations of $50,000 or over for the National Institutes of Health or a national research
p.000811: institute for carrying out the pur- poses of this title may be acknowledged by the establishment with- in the
p.000811: National Institutes of Health or a national research institute of suitable memorials to the donors.
p.000811:
p.000811: FETAL RESEARCH
p.000811: SEC. 498. ø289g¿ (a) The Secretary may not conduct or support any research or experimentation, in the United
p.000811: States or in any other country, on a nonviable living human fetus ex utero or a liv- ing human fetus ex
p.000811: utero for whom viability has not been ascertained unless the research or experimentation—
p.000811: (1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its
p.000811: survival to viabil- ity; or
p.000811: (2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or
p.000811: experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
p.000811: (b) In administering the regulations for the protection of human research subjects which—
p.000811: (1) apply to research conducted or supported by the Sec- retary;
p.000811: (2) involve living human fetuses in utero; and
p.000811: (3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
p.000811: or any successor to such regulations, the Secretary shall require that the risk standard (published in
p.000811: section 46.102(g) of such part
p.000811: 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and
p.000811: fetuses which are intended to be carried to term.
p.000811:
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p.000811: January 30, 2020
p.000811: RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
p.000811: SEC. 498A. ø289g–1¿ (a) ESTABLISHMENT OF PROGRAM.—
p.000811: (1) IN GENERAL.—The Secretary may conduct or support research on the transplantation of human fetal
p.000811: tissue for therapeutic purposes.
p.000811: (2) SOURCE OF TISSUE.—Human fetal tissue may be used in research carried out under paragraph (1)
p.000811: regardless of
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p.000813: audit, the Secretary shall—
p.000813: (A) use such material or information only for the pur- poses of verifying compliance with the requirements of this
p.000813: section;
p.000813: (B) not disclose or publish such material or informa- tion, except where required by Federal law, in
p.000813: which case such material or information shall be coded in a manner such that the identities of such
p.000813: individuals and entities are protected; and
p.000813: (C) not maintain such material or information after completion of such audit, except where necessary for
p.000813: the purposes of such audit.
p.000813: (e) APPLICABILITY OF STATE AND LOCAL LAW.—
p.000813: (1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE.— The Secretary may not provide support for research under sub-
p.000813: section (a) unless the applicant for the financial assistance in- volved agrees to conduct the research in accordance
p.000813: with appli- cable State law.
p.000813: (2) RESEARCH CONDUCTED BY SECRETARY.—The Secretary may conduct research under subsection (a) only in
p.000813: accordance with applicable State and local law.
p.000813: (f) REPORT.—The Secretary shall annually submit to the Com- mittee on Energy and Commerce of the House of
p.000813: Representatives, and to the Committee on Labor and Human Resources of the Sen- ate, a report describing the activities
p.000813: carried out under this section during the preceding fiscal year, including a description of whether and to what
p.000813: extent research under subsection (a) has been con- ducted in accordance with this section.
p.000813: (g) DEFINITION.—For purposes of this section, the term ‘‘human fetal tissue’’ means tissue or cells obtained from a
p.000813: dead human em- bryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000813:
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p.000813: Sec. 498B PUBLIC HEALTH SERVICE ACT 814
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p.000813: January 30, 2020
p.000813:
p.000813: PROHIBITIONS REGARDING HUMAN FETAL TISSUE
p.000813: SEC. 498B. ø289g–2¿ (a) PURCHASE OF TISSUE.—It shall be un-
p.000813: lawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for
p.000813: valuable consideration if the transfer affects interstate commerce.
p.000813: (b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DO- NATION FOR USE IN TRANSPLANTATION.—It shall
p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
p.000813: (3) The term ‘‘valuable consideration’’ does not include rea- sonable payments associated with the transportation,
p.000813: implan- tation, processing, preservation, quality control, or storage of human fetal tissue.
p.000813: SEC. 498C. ø289g–3¿ BREAST IMPLANT RESEARCH.
p.000813: (a) IN GENERAL.—The Director of NIH may conduct or support research to examine the long-term health implications
p.000813: of silicone
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001551: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1552
p.001551:
p.001551: with a group health plan, shall not request, require, or pur- chase genetic information for underwriting
p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
p.001551: surance issuer offering health insurance coverage in connection with a group health plan, shall not request,
p.001551: require, or pur- chase genetic information with respect to any individual prior to such individual’s
p.001551: enrollment under the plan or coverage in connection with such enrollment.
p.001551: (3) INCIDENTAL COLLECTION.—If a group health plan, or a health insurance issuer offering health insurance
p.001551: coverage in connection with a group health plan, obtains genetic informa- tion incidental to the
p.001551: requesting, requiring, or purchasing of other information concerning any individual, such request, re-
p.001551: quirement, or purchase shall not be considered a violation of paragraph (2) if such request, requirement, or
p.001551: purchase is not in violation of paragraph (1).
p.001551: (e) APPLICATION TO ALL PLANS.—The provisions of subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1) and
p.001551: section 2704 with respect to genetic information, shall apply to group health plans and health insurance
p.001551: issuers without regard to section 2735(a).
p.001551: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001551: individual or family member of an individual shall—
p.001551: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001551: infor- mation of any fetus carried by such pregnant woman; and
p.001551: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001551: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001551: (j) 5 PROGRAMS OF HEALTH PROMOTION OR DISEASE PREVEN-
p.001551: TION.—
p.001551: (1) GENERAL PROVISIONS.—
p.001551: (A) GENERAL RULE.—For purposes of subsection (b)(2)(B), a program of health promotion or disease preven-
p.001551: tion (referred to in this subsection as a ‘‘wellness pro- gram’’) shall be a program offered by an
p.001551: employer that is designed to promote health or prevent disease that meets the applicable requirements of this
p.001551: subsection.
p.001551: (B) NO CONDITIONS BASED ON HEALTH STATUS FAC- TOR.—If none of the conditions for obtaining a
p.001551: premium discount or rebate or other reward for participation in a wellness program is based on an
p.001551: individual satisfying a standard that is related to a health status factor, such wellness program shall not
p.001551: violate this section if participa- tion in the program is made available to all similarly situ- ated individuals and
p.001551: the requirements of paragraph (2) are complied with.
p.001551: (C) CONDITIONS BASED ON HEALTH STATUS FACTOR.—If any of the conditions for obtaining a premium discount or
p.001551:
p.001551:
p.001551:
p.001551: January 30, 2020
p.001551: 5 So in law. There are no subsections (g)–(i).
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001551:
p.001551:
p.001551:
p.001551:
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p.001609: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001609: (D) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to
p.001609: the excep- tion provided for under this paragraph, including a de- scription of the activities conducted.
p.001609: (E) The issuer complies with such other conditions as the Secretary may by regulation require for activities
p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
p.001609: information concerning any indi- vidual, such request, requirement, or purchase shall not be considered a
p.001609: violation of paragraph (2) if such request, require- ment, or purchase is not in violation of paragraph (1).
p.001609: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001609: individual or family member of an individual shall—
p.001609: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001609: infor- mation of any fetus carried by such pregnant woman; and
p.001609: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001609: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001609: Sec. 2761 PUBLIC HEALTH SERVICE ACT 1610
p.001609:
p.001609: Subpart 3—General Provisions 25
p.001609: SEC. 2761. ø300gg–61¿ ENFORCEMENT.
p.001609: (a) STATE ENFORCEMENT.—
p.001609: (1) STATE AUTHORITY.—Subject to section 2762, each State may require that health insurance issuers that issue,
p.001609: sell, renew, or offer health insurance coverage in the State in the individual market meet the
p.001609: requirements established under this part with respect to such issuers.
p.001609: (2) FAILURE TO IMPLEMENT REQUIREMENTS.—In the case of a State that fails to substantially enforce the requirements
p.001609: set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the
p.001609: requirements of this part under subsection (b) insofar as they relate to the issuance, sale, renewal, and offering of
p.001609: health insurance coverage in the individual market in such State.
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p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
p.000749: for drug abuse and addiction may be used for research and clinical trials relating to—
p.000749: (A) the effects of drug abuse on the human body, in- cluding the brain;
p.000749: (B) the addictive nature of drugs and how such effects differ with respect to different individuals;
p.000749: (C) the connection between drug abuse and mental health;
p.000749: (D) the identification and evaluation of the most effec- tive methods of prevention of drug abuse and addiction;
p.000749: (E) the identification and development of the most ef- fective methods of treatment of drug addiction,
p.000749: including pharmacological treatments;
p.000749: (F) risk factors for drug abuse;
p.000749: (G) effects of drug abuse and addiction on pregnant women and their fetuses; and
p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
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p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000751: with respect to AIDS research related to—
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p.000811: institute for carrying out the pur- poses of this title may be acknowledged by the establishment with- in the
p.000811: National Institutes of Health or a national research institute of suitable memorials to the donors.
p.000811:
p.000811: FETAL RESEARCH
p.000811: SEC. 498. ø289g¿ (a) The Secretary may not conduct or support any research or experimentation, in the United
p.000811: States or in any other country, on a nonviable living human fetus ex utero or a liv- ing human fetus ex
p.000811: utero for whom viability has not been ascertained unless the research or experimentation—
p.000811: (1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its
p.000811: survival to viabil- ity; or
p.000811: (2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or
p.000811: experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
p.000811: (b) In administering the regulations for the protection of human research subjects which—
p.000811: (1) apply to research conducted or supported by the Sec- retary;
p.000811: (2) involve living human fetuses in utero; and
p.000811: (3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
p.000811: or any successor to such regulations, the Secretary shall require that the risk standard (published in
p.000811: section 46.102(g) of such part
p.000811: 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and
p.000811: fetuses which are intended to be carried to term.
p.000811:
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p.000811: January 30, 2020
p.000811: RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
p.000811: SEC. 498A. ø289g–1¿ (a) ESTABLISHMENT OF PROGRAM.—
p.000811: (1) IN GENERAL.—The Secretary may conduct or support research on the transplantation of human fetal
p.000811: tissue for therapeutic purposes.
p.000811: (2) SOURCE OF TISSUE.—Human fetal tissue may be used in research carried out under paragraph (1)
p.000811: regardless of
p.000811: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000811:
p.000811: Sec. 498A PUBLIC HEALTH SERVICE ACT 812
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p.000811: January 30, 2020
p.000811:
p.000811: whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.
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p.000813: January 30, 2020
p.000813:
p.000813: PROHIBITIONS REGARDING HUMAN FETAL TISSUE
p.000813: SEC. 498B. ø289g–2¿ (a) PURCHASE OF TISSUE.—It shall be un-
p.000813: lawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for
p.000813: valuable consideration if the transfer affects interstate commerce.
p.000813: (b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DO- NATION FOR USE IN TRANSPLANTATION.—It shall
p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
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p.000001: members shall be individuals qualified by training and experience in the medical sciences or in the adminis-
p.000001: tration of health programs.
p.000001: (c) Each member of the Council shall hold office for a term of four years, except that (1) any member
p.000001: appointed to fill a vacancy occurring prior to the expiration of the term for which his prede- cessor was
p.000001: appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after
p.000001: the date of enactment of this subsection shall expire as follows: four shall expire four years after such
p.000001: date, four shall expire three years after such date, four shall expire two years after such date, and three
p.000001: shall expire one year after such date, as designated by the Secretary at the time of appointment.
p.000001: (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
p.000001: TRAINING OF OFFICERS
p.000001: SEC. 218. ø218a¿ (a) Appropriations available for the pay and allowances of commissioned officers of the
p.000001: Service shall also be available for the pay and allowances of any such officer on active
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 8 As a result of the amendments made by Public Law 104–299 (110 Stat. 3626), the Public Health Service
p.000001: Act no longer contained a section 329, 340, or 340A, and section 330 of such Act was substantially revised. Section
p.000001: 330 now includes provisions that relate to medically under- served populations, to migratory and seasonal
p.000001: agricultural workers, to homeless individuals, and to residents of public housing. Section 402 of Public Law 107–251
p.000001: (116 Stat. 1655) added a new section 340 that relates to a healthy communities access program.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 23 PUBLIC HEALTH SERVICE ACT Sec. 219
p.000001:
p.000001: duty while attending any Federal or non-Federal educational insti- tution or training program and, subject to
p.000001: regulations of the Presi- dent and to the limitation prescribed in such appropriations, for payment of his
p.000001: tuition, fees, and other necessary expenses incident to such attendance.
p.000001: (b) Any officer whose tuition, fees, and other necessary ex- penses are paid pursuant to subsection (a) while
p.000001: attending an edu- cational institution or training program for a period in excess of thirty days shall be
p.000001: obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other
p.000001: necessary expenses received by such officer during such period, and two times the total amount of any
p.000001: compensation received by, and any allowance paid to, such officer during such period, if after re- turn
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p.000257: January 30, 2020
p.000257: (2) enter into agreement or arrangements with hospitals and other health care facilities for the mutual
p.000257: use or the ex- change of use of specialized health resources, and providing for reciprocal reimbursement.
p.000257: Any reimbursement pursuant to any such agreement or arrange- ment shall be based on charges covering the
p.000257: reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to
p.000257: the Government under this subsection shall be credited to the applicable appropriation of the Public Health
p.000257: Service for the year in which such proceeds are received.
p.000257: PART D—PRIMARY HEALTH CARE
p.000257: Subpart I—Health Centers
p.000257: SEC. 330. ø254b¿ HEALTH CENTERS.
p.000257: (a) DEFINITION OF HEALTH CENTER.—
p.000257: (1) IN GENERAL.—For purposes of this section, the term ‘‘health center’’ means an entity that serves a
p.000257: population that
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000257:
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p.000257: Sec. 330 PUBLIC HEALTH SERVICE ACT 258
p.000257:
p.000257: is medically underserved, or a special medically underserved population comprised of migratory and seasonal
p.000257: agricultural workers, the homeless, and residents of public housing, by pro- viding, either through the staff and
p.000257: supporting resources of the center or through contracts or cooperative arrangements—
p.000257: (A) required primary health services (as defined in subsection (b)(1)); and
p.000257: (B) as may be appropriate for particular centers, addi- tional health services (as defined in subsection (b)(2)) nec-
p.000257: essary for the adequate support of the primary health services required under subparagraph (A);
p.000257: for all residents of the area served by the center (hereafter re- ferred to in this section as the ‘‘catchment area’’).
p.000257: (2) LIMITATION.—The requirement in paragraph (1) to pro- vide services for all residents within a catchment
p.000257: area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i).
p.000257: (b) DEFINITIONS.—For purposes of this section:
p.000257: (1) REQUIRED PRIMARY HEALTH SERVICES.—
p.000257: (A) IN GENERAL.—The term ‘‘required primary health services’’ means—
p.000257: (i) basic health services which, for purposes of this section, shall consist of—
p.000257: (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology
p.000257: that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse
p.000257: midwives;
p.000257: (II) diagnostic laboratory and radiologic serv- ices;
p.000257: (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening;
p.000257: (cc) well-child services;
p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
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p.000265: Sec. 330 PUBLIC HEALTH SERVICE ACT 266
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p.000265: January 30, 2020
p.000265:
p.000265: tablishes for the purposes of such employment a temporary abode.
p.000265: (B) SEASONAL AGRICULTURAL WORKER.—The term ‘‘sea- sonal agricultural worker’’ means an individual whose
p.000265: principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.
p.000265: (C) AGRICULTURE.—The term ‘‘agriculture’’ means farming in all its branches, including—
p.000265: (i) cultivation and tillage of the soil;
p.000265: (ii) the production, cultivation, growing, and har- vesting of any commodity grown on, in, or as an ad-
p.000265: junct to or part of a commodity grown in or on, the land; and
p.000265: (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to
p.000265: carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an
p.000265: activity described in clause (ii).
p.000265: (h) HOMELESS POPULATION.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of homeless
p.000265: individuals, including grants for innovative programs that provide outreach and com- prehensive primary health
p.000265: services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and
p.000265: veterans at risk of homelessness.
p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
p.000265: (A) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ means an individual who lacks housing (without
p.000265: regard to whether the individual is a member of a family), including an individual whose primary residence during
p.000265: the night is a supervised public or private facility that pro- vides temporary living accommodations and an
p.000265: individual who is a resident in transitional housing.
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000267: 267
p.000267: PUBLIC HEALTH SERVICE ACT
p.000267: Sec. 330
p.000267:
p.000267: (B) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘substance abuse 31services’’ includes detoxification,
p.000267: risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse 31 provided
p.000267: in settings other than hospitals.
p.000267: (i) RESIDENTS OF PUBLIC HOUSING.—
p.000267: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000267: the plan- ning and delivery of services to a special medically under- served population comprised of
...

p.000285: (i) among whose primary purposes are adoption;
p.000285: (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa-
p.000285: tion and referrals to pregnant women; and
p.000285: (iii) that is a nonprofit private entity.
p.000285: (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who
p.000285: provide pregnancy or adoption information and referrals (or will provide such information and referrals
p.000285: after receiving training under a grant under paragraph (1)).
p.000285: (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health
p.000285: services to pregnant women.
p.000285: (5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A condition for the receipt of a grant under paragraph (1) is
p.000285: that the adoption organization involved agree to make reasonable efforts to ensure that the eligible
p.000285: health centers with respect to which training under the grant is provided include—
p.000285: (A) eligible health centers that receive grants under section 1001 (relating to voluntary family
p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000285: adoption informa- tion and referral, upon request, are provided by eligible
p.000285:
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p.000285: January 30, 2020
p.000285: 36 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000285:
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p.000307: PUBLIC HEALTH SERVICE ACT
p.000307: Sec. 332
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p.000307: January 30, 2020
p.000307: (B) such a facility of a State correctional institution or of the Indian Health Service, and a health program
p.000307: or facility op- erated by a tribe or tribal organization under the Indian Self- Determination Act;
p.000307: (C) such a facility used in connection with the delivery of health services under section 321 (relating
p.000307: to hospitals), 322 (relating to care and treatment of persons under quarantine and others), 323 (relating
p.000307: to care and treatment of Federal prisoners), 324 (relating to examination and treatment of cer- tain
p.000307: Federal employees), 325 (relating to examination of aliens), 326 (relating to services to certain Federal
p.000307: employees), 320 (relating to services for persons with Hansen’s disease), or 330(h) (relating to the provision of
p.000307: health services to homeless individuals); and
p.000307: (D) a Federal medical facility.
p.000307: (3) Homeless individuals (as defined in section 330(h)(5)), sea- sonal agricultural workers (as defined in
p.000307: section 330(g)(3)) and mi- gratory agricultural workers (as so defined)), and residents of pub- lic housing (as defined
p.000307: in section 3(b)(1) of the United States Hous- ing Act of 1937 (42 U.S.C. 1437a(b)(1))) may be population
p.000307: groups under paragraph (1).
p.000307: (b) The Secretary shall establish by regulation criteria for the designation of areas, population
p.000307: groups, medical facilities, and other public facilities, in the States, as health professional shortage areas.
p.000307: In establishing such criteria, the Secretary shall take into consideration the following:
p.000307: (1) The ratio of available health manpower to the number of individuals in an area or population group, or
p.000307: served by a medical facility or other public facility under consideration for designation.
p.000307: (2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the
p.000307: individuals in an area or population group or served by a medical facility or other public facility under
p.000307: consideration for designation.
p.000307: (3) The percentage of physicians serving an area, popu- lation group, medical facility, or other public
p.000307: facility under con- sideration for designation who are employed by hospitals and who are graduates of foreign
p.000307: medical schools.
p.000307: (c) In determining whether to make a designation, the Sec- retary shall take into consideration the following:
p.000307: (1) The recommendations of the Governor of each State in which the area, population group, medical facility, or
p.000307: other public facility under consideration for designation is in whole or part located.
...

p.000369: contracts under this Act, each of the entities specified in subsection (c) shall, to the extent
p.000369: determined to be appropriate by the Secretary, make available in- formation concerning breast and cervical
p.000369: cancer.
p.000369: (b) CERTAIN AUTHORITIES.—In carrying out subsection (a), an entity specified in subsection (c)—
p.000369: (1) may make the information involved available to such individuals as the entity determines appropriate;
p.000369: (2) may, as appropriate, provide information under sub- section (a) on the need for self-examination of the
p.000369: breasts and on the skills for such self-examinations;
p.000369: (3) shall provide information under subsection (a) in the language and cultural context most appropriate to the
p.000369: individ- uals to whom the information is provided; and
p.000369: (4) shall refer such clients as the entities determine appro- priate for breast and cervical cancer screening,
p.000369: treatment, or other appropriate services.
p.000369: (c) RELEVANT ENTITIES.—The entities specified in this sub- section are the following:
p.000369: (1) Entities receiving assistance under section 317F (relat- ing to tuberculosis) 53.
p.000369: (2) Entities receiving assistance under section 318 (relat- ing to sexually transmitted diseases).
p.000369: (3) Migrant health centers receiving assistance under sec- tion 329 54.
p.000369: (4) Community health centers receiving assistance under section 330 54.
p.000369: (5) Entities receiving assistance under section 330(h) (re- lating to homeless individuals).
p.000369: (6) Entities receiving assistance under section 340A 54 (re- lating to health services for residents of public
p.000369: housing).
p.000369: (7) Entities providing services with assistance under title V or title XIX.
p.000369: (8) Entities receiving assistance under section 1001 (relat- ing to family planning).
p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
p.000369:
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p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: January 30, 2020
p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
...

p.000845: relative costs of each such treatment modality provided within a State in each fiscal year;
p.000845: (H) to the extent of available information, the number of individuals receiving treatment for alcohol or
p.000845: drug abuse who have private insurance coverage for the costs of such treat- ment;
p.000845: (I) the extent of alcohol and drug abuse among high school students and among the general population; and
p.000845: (J) the number of alcohol and drug abuse counselors and other substance abuse treatment personnel employed in
p.000845: public and private treatment facilities.
p.000845: (2) ANNUAL SURVEYS; PUBLIC AVAILABILITY OF DATA.—Annual survey 4s shall be carried out in the
p.000845: collection of data under this subsection. Summaries and analyses of the data collected shall be made
p.000845: available to the public.
p.000845: (e) CONSULTATION.—After consultation with the States and with appropriate national organizations, the
p.000845: Assistant Secretary shall use existing standards and best practices to develop uniform criteria for the
p.000845: collection of data, using the best available tech- nology, pursuant to this section.
p.000845: SEC. 506. ø290aa–5¿ GRANTS FOR THE BENEFIT OF HOMELESS INDIVID- UALS.
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts and cooperative agreements to community-based public
p.000845: and private nonprofit entities for the purposes of providing mental health and substance use disorder
p.000845: services for homeless individuals. In car- rying out this section, the Secretary shall consult with the
p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
p.000845: (b) PREFERENCES.—In awarding grants, contracts, and coopera- tive agreements under subsection (a), the Secretary
p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
p.000845: homeless in- dividuals;
p.000845: (2) entities that demonstrate effectiveness in serving run- away, homeless, and street youth;
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 4 The heading for paragraph (2) is the result of the amendment made by section 6004(6)(C) of Public Law
p.000845: 114–255. Such amendment probably should not have been made to strike ‘‘AN- NUAL SURVEYS’’ (initial cap and
p.000845: small caps) and instead should have been ‘‘Annual Surveys’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000845:
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p.000845: Sec. 506A PUBLIC HEALTH SERVICE ACT 846
p.000845:
p.000845: (3) entities that have experience in providing substance use disorder and mental health services to
p.000845: homeless individ- uals;
p.000845: (4) entities that demonstrate experience in providing hous- ing for individuals in treatment for or in recovery from
p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
p.000845: (1) prohibit the provision of services under such subsection to homeless individuals who are suffering from a substance
p.000845: use disorder and are not suffering from a mental health disorder; and
p.000845: (2) make payments under subsection (a) to any entity that has a policy of—
p.000845: (A) excluding individuals from mental health services due to the existence or suspicion of a substance
p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
...

p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: more than 5 per- cent shall be available to the Assistant Secretary for carrying out subsection (d).
p.000899: PART C—PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS
p.000899: SEC. 521. ø290cc–21¿ FORMULA GRANTS TO STATES.
p.000899: For the purpose of carrying out section 522, the Secretary, act- ing through the Director of the Center for Mental
p.000899: Health Services, shall for each of the fiscal years 2018 through 2022 make an allot- ment for each State in an
p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
p.000899: (B) providing assistance in obtaining and coordinating social and maintenance services for the eligible homeless
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000901: 901
p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
p.000901: transportation serv- ices, and habilitation and rehabilitation services, prevocational and
p.000901: vocational services, and housing serv- ices;
p.000901: (C) providing assistance to the eligible homeless indi- vidual in obtaining income support services,
p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
p.000901: benefits;
p.000901: (D) referring the eligible homeless individual for such other services as may be appropriate; and
p.000901: (E) providing representative payee services in accord- ance with section 1631(a)(2) of the Social Security
p.000901: Act if the eligible homeless individual is receiving aid under title XVI of such act and if the applicant is
p.000901: designated by the Secretary to provide such services;
p.000901: (8) supportive and supervisory services in residential set- tings;
p.000901: (9) referrals for primary health services, job training, edu- cational services, and relevant housing services;
p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
p.000901:
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p.000901: January 30, 2020
p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
p.000901:
p.000901:
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p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that not more than 4 percent of the payments will be expended for ad- ministrative
p.000901: expenses regarding the payments.
p.000901: (g) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that—
p.000901: (1) not more than 20 percent of the payments will be ex- pended for housing services under subsection
p.000901: (b)(10); and
p.000901: (2) the payments will not be expended—
...

p.000901: and $50,000 for each of Guam, the Virgin Islands, American Samoa, and the Commonwealth of the Northern Mariana
p.000901: Islands; and
p.000901: (2) an amount determined in accordance with subsection
p.000901:
p.000901:
p.000901:
p.000901:
p.000901: January 30, 2020
p.000901: (b).
p.000901: (b) DETERMINATION UNDER FORMULA.—The amount referred to in subsection (a)(2) is the product of—
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
p.000901:
p.000901:
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p.000903: 903
p.000903: PUBLIC HEALTH SERVICE ACT
p.000903: Sec. 526
p.000903:
p.000903: (1) an amount equal to the amount appropriated under section 535(a) for the fiscal year; and
p.000903: (2) a percentage equal to the quotient of—
p.000903: (A) an amount equal to the population living in urban- ized areas of the State involved, as indicated by the
p.000903: most recent data collected by the Bureau of the Census; and
p.000903: (B) an amount equal to the population living in urban- ized areas of the United States, as indicated by the
p.000903: sum of the respective amounts determined for the States under subparagraph (A).
p.000903: SEC. 525. ø290cc–25¿ CONVERSION TO CATEGORICAL PROGRAM IN EVENT OF FAILURE OF STATE REGARDING EXPENDITURE
p.000903: OF GRANTS.
p.000903: (a) IN GENERAL.—Subject to subsection (c), the Secretary shall, from the amounts specified in subsection (b), make
p.000903: grants to public and nonprofit private entities for the purpose of providing to eligi- ble homeless individuals the
p.000903: services specified in section 522(b).
p.000903: (b) 14 SPECIFICATION OF FUNDS.—The amounts referred to in subsection (a) are any amounts made available
p.000903: in appropriations Acts for allotments under section 521 that are not paid to a State as a result of—
p.000903:
p.000903: (A) the failure of the State to submit an application under section 529;
p.000903: (B) the failure of the State, in the determination of the Secretary, to prepare the application in accordance
p.000903: with such section or to submit the application within a reason- able period of time; or
p.000903: (C) the State informing the Secretary that the State does not intend to expend the full amount of the allotment
p.000903: made to the State.
p.000903: (c) REQUIREMENT OF PROVISION OF SERVICES IN STATE IN- VOLVED.—With respect to grants under
p.000903: subsection (a), amounts made available under subsection (b) as a result of the State in- volved shall be
p.000903: available only for grants to provide services in such State.
p.000903: SEC. 526. ø290cc–26¿ PROVISION OF CERTAIN INFORMATION FROM STATE.
p.000903: The Secretary may not make payments under section 521 to a State unless, as part of the application required in section
p.000903: 529, the State submits to the Secretary a statement—
p.000903: (1) identifying existing programs providing services and housing to eligible homeless individuals and
p.000903: identify gaps in the delivery systems of such programs;
p.000903: (2) containing a plan for providing services and housing to eligible homeless individuals, which plan—
p.000903: (A) describes the coordinated and comprehensive means of providing services and housing to homeless indi-
p.000903: viduals; and
p.000903:
p.000903:
p.000903:
p.000903:
p.000903: January 30, 2020
p.000903: 14 So in law. Subparagraphs (A) through (C) probably should be redesignated as paragraphs
p.000903: (1) through (3), respectively. See section 511 of Public Law 104–645 (104 Stat. 4729).
p.000903: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000903:
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p.000903:
p.000903: Sec. 527 PUBLIC HEALTH SERVICE ACT 904
p.000903:
p.000903:
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p.000903: January 30, 2020
p.000903:
p.000903: (B) includes documentation that suitable housing for eligible homeless individuals will accompany the provision
p.000903: of services to such individuals;
p.000903: (3) describes the source of the non-Federal contributions described in section 523;
p.000903: (4) contains assurances that the non-Federal contributions described in section 523 will be available at the
p.000903: beginning of the grant period;
p.000903: (5) describe any voucher system that may be used to carry out this part; and
p.000903: (6) contain such other information or assurances as the Secretary may reasonably require.
p.000903: SEC. 527. ø290cc–27¿ DESCRIPTION OF INTENDED EXPENDITURES OF GRANT.
p.000903: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless—
p.000903: (1) as part of the application required in section 529, the State involved submits to the Secretary a
p.000903: description of the in- tended use for the fiscal year of the amounts for which the State is applying
p.000903: pursuant to such section;
p.000903: (2) such description identifies the geographic areas within the State in which the greatest numbers of
p.000903: homeless individ- uals with a need for mental health, substance use disorder, and housing services are
p.000903: located;
p.000903: (3) such description provides information relating to the programs and activities to be supported and services
p.000903: to be pro- vided, including information relating to coordinating such pro- grams and activities with any similar
p.000903: programs and activities of public and private entities; and
p.000903: (4) the State agrees that such description will be revised throughout the year as may be necessary to reflect
p.000903: substantial changes in the programs and activities assisted by the State pursuant to section 522.
p.000903: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 521 unless the
p.000903: State involved agrees that, in developing and carrying out the description required in subsection (a), the State
p.000903: will provide public notice with respect to the description (including any revisions) and such
p.000903: opportunities as may be necessary to provide interested persons, such as family members, consumers, and
p.000903: mental health, substance use disorder, and housing agencies, an opportunity to present comments and rec-
p.000903: ommendations with respect to the description.
p.000903: (c) RELATIONSHIP TO STATE COMPREHENSIVE MENTAL HEALTH SERVICES PLAN.—
p.000903: (1) IN GENERAL.—The Secretary may not make payments under section 521 unless the services to be provided
p.000903: pursuant to the description required in subsection (a) are consistent with the State comprehensive mental health
...

p.000905: the repay- ment against the amount of any payment due to be paid to the State under section 521.
p.000905: (b) WITHHOLDING OF PAYMENTS.—
p.000905: (1) The Secretary may, subject to subsection (c), withhold payments due under section 521 if the
p.000905: Secretary determines that the State involved is not expending amounts received under such section in
p.000905: accordance with the agreements required to be contained in the application submitted by the State pur- suant to section
p.000905: 529.
p.000905: (2) The Secretary shall cease withholding payments from a State under paragraph (1) if the Secretary
p.000905: determines that there are reasonable assurances that the State will expend amounts received under section
p.000905: 521 in accordance with the agreements referred to in such paragraph.
p.000905: (3) The Secretary may not withhold funds under para- graph (1) from a State for a minor failure to
p.000905: comply with the agreements referred to in such paragraph.
p.000905: (c) OPPORTUNITY FOR HEARING.—Before requiring repayment of payments under subsection (a)(1), or withholding
p.000905: payments under subsection (b)(1), the Secretary shall provide to the State an oppor- tunity for a hearing.
p.000905: (d) RULE OF CONSTRUCTION.—Notwithstanding any other pro- vision of this part, a State receiving payments
p.000905: under section 521 may not, with respect to any agreements required to be contained in the application
p.000905: submitted under section 529, be considered to be in violation of any such agreements by reason of the fact
p.000905: that the State, in the regular course of providing services under section 522(b) to eligible homeless
p.000905: individuals, incidentally provides serv- ices to homeless individuals who are not eligible homeless individ- uals.
p.000905: SEC. 532. ø290cc–32¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.000905: (a) IN GENERAL.—
p.000905: (1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in
p.000905: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.000905: payments received by the State under section 521.
p.000905: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
p.000905: amount in an amount greater than the amount the person is authorized to receive.
p.000905: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.000905: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.000905: for not more than 5 years, or both.
p.000905: SEC. 533. ø290cc–33¿ NONDISCRIMINATION.
p.000905: (a) IN GENERAL.—
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000905:
p.000905:
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p.000907: 907
p.000907: PUBLIC HEALTH SERVICE ACT
p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
...

p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
p.000907: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.000907: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.000907: Rights Act of 1964, as may be applicable; or
p.000907: (C) take such other actions as may be authorized by
p.000907:
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p.000907: January 30, 2020
p.000907: law.
p.000907: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000907:
p.000907: Sec. 535 PUBLIC HEALTH SERVICE ACT 908
p.000907:
p.000907: (2) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ has the meaning given such term in
p.000907: section 330(h)(5).
p.000907: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000907: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.000907: (4) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘sub- stance use disorder services’’ has the meaning
p.000907: given the term ‘‘substance abuse services’’ in section 330(h)(5)(C).
p.000907: SEC. 535. ø290cc–35¿ FUNDING.
p.000907: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there is authorized to
p.000907: be appropriated
p.000907: $64,635,000 for each of fiscal years 2018 through 2022.
p.000907: (b) EFFECT OF INSUFFICIENT APPROPRIATIONS FOR MINIMUM ALLOTMENTS.—
p.000907: (1) IN GENERAL.—If the amounts made available under subsection (a) for a fiscal year are insufficient
p.000907: for providing each State with an allotment under section 521 of not less than the applicable amount under section
p.000907: 524(a)(1), the Secretary shall, from such amounts as are made available under such subsection, make grants
p.000907: to the States for providing to eligible homeless individuals the services specified in section 522(b).
p.000907: (2) RULE OF CONSTRUCTION.—Paragraph (1) may not be construed to require the Secretary to make a grant under such
p.000907: paragraph to each State.
p.000907: PART D—MISCELLANEOUS PROVISIONS RELATING TO SUBSTANCE ABUSE AND MENTAL HEALTH
p.000907: SEC. 541. ø290dd¿ SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
p.000907: (a) PROGRAMS AND SERVICES.—
p.000907: (1) DEVELOPMENT.—The Secretary, acting through the As- sistant Secretary for Mental Health and Substance
p.000907: Use, shall be responsible for fostering substance abuse prevention and treatment programs and services in
p.000907: State and local govern- ments and in private industry.
p.000907: (2) MODEL PROGRAMS.—
p.000907: (A) IN GENERAL.—Consistent with the responsibilities described in paragraph (1), the Secretary, acting
p.000907: through the Assistant Secretary for Mental Health and Substance Use, shall develop a variety of model programs
p.000907: suitable for replication on a cost-effective basis in different types of business concerns and State and
p.000907: local governmental enti- ties.
p.000907:
p.000907:
p.000907:
p.000907:
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p.000907: January 30, 2020
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p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
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p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
p.001053: dis- tribution of mental and substance use disorders services;
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p.001079: of doctor of dentistry or an equivalent degree, a degree of doctor of veterinary medicine or an
p.001079: equivalent degree, a degree of
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001079:
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p.001079:
p.001081: 1081
p.001081: PUBLIC HEALTH SERVICE ACT
p.001081: Sec. 799B
p.001081:
p.001081: doctor of optometry or an equivalent degree, a degree of doctor of podiatric medicine or an equivalent degree,
p.001081: a de- gree of bachelor of science in pharmacy or an equivalent degree, a degree of doctor of pharmacy or an
p.001081: equivalent de- gree, a graduate degree in public health or an equivalent degree, a degree of doctor of
p.001081: chiropractic or an equivalent degree, a graduate degree in health administration or an equivalent degree,
p.001081: a doctoral degree in clinical psychology or an equivalent degree, or a degree in social work or an
p.001081: equivalent degree or a degree in counseling or an equiva- lent degree.
p.001081: (6) The term ‘‘medically underserved community’’ means an urban or rural area or population that—
p.001081: (A) is eligible for designation under section 332 as a health professional shortage area;
p.001081: (B) is eligible to be served by a migrant health center under section 329 25, a community health center under sec- tion
p.001081: 330 25, a grantee under section 330(h) (relating to homeless individuals), or a grantee under section
p.001081: 340A 25 (relating to residents of public housing);
p.001081: (C) has a shortage of personal health services, as de- termined under criteria issued by the Secretary under
p.001081: sec- tion 1861(aa)(2) of the Social Security Act (relating to rural health clinics); or
p.001081: (D) is designated by a State Governor (in consultation with the medical community) as a shortage area or medi-
p.001081: cally underserved community.
p.001081: (7) The term ‘‘Department’’ means the Department of Health and Human Services.
p.001081: (8) The term ‘‘nonprofit’’ refers to the status of an entity owned and operated by one or more
p.001081: corporations or associa- tions no part of the net earnings of which inures, or may law- fully inure, to the
p.001081: benefit of any private shareholder or indi- vidual.
p.001081: (9) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.001081: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.001081: American Samoa, and the Trust Territory of the Pacific Islands.
p.001081: (10)(A) Subject to subparagraph (B), the term ‘‘underrep- resented minorities’’ means, with respect to a
p.001081: health profes- sion, racial and ethnic populations that are underrepresented in the health profession
p.001081: relative to the number of individuals who are members of the population involved.
p.001081: (B) For purposes of subparagraph (A), Asian individuals shall be considered by the various subpopulations of
p.001081: such indi- viduals.
p.001081: (11) The term ‘‘psychologist’’ means an individual who—
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p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
p.001091:
p.001091:
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p.001091: January 30, 2020
p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001091:
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p.001091: Sec. 831 PUBLIC HEALTH SERVICE ACT 1092
p.001091:
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p.001091:
p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
p.001091: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to paragraph
p.001091: (1) or (2).
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p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
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p.001443: January 30, 2020
p.001443:
p.001443: (1) ESTABLISHMENT.—To be eligible for assistance under this subpart, the chief elected official described
p.001443: in subsection (a)(1) shall establish or designate an HIV health services plan- ning council that shall reflect in
p.001443: its composition the demo- graphics of the population of individuals with HIV/AIDS in the eligible area involved,
p.001443: with particular consideration given to disproportionately affected and historically underserved groups and
p.001443: subpopulations. Nominations for membership on the coun- cil shall be identified through an open process and
p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
...

p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001459:
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p.001461: 1461
p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
...

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p.001463: January 30, 2020
p.001463:
p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
p.001463: (B) by an entity that provides health services on a pre- paid basis;
p.001463: (7) to the maximum extent practicable, that—
p.001463: (A) HIV health care and support services provided with assistance made available under this subpart will be
p.001463: provided without regard—
p.001463: (i) to the ability of the individual to pay for such services; and
...

p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
...

p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
p.001483: (E) describing efforts to remove legal barriers, includ- ing State laws and regulations, to routine testing.
p.001483: (c) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001483: SERVICES.—
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: January 30, 2020
p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
p.000827: workforce ad- dressing mental and substance use disorders;
p.000827: (23) collaborate with the Attorney General and representa- tives of the criminal justice system to improve mental and
p.000827: sub- stance use disorders services for individuals who have been ar- rested or incarcerated;
p.000827: (24) after providing an opportunity for public input, set standards for grant programs under this title
p.000827: for mental and substance use disorders services and prevention programs, which standards may address—
p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
...

p.000921: (ii) submits to the Secretary a certification by the at- torney general of the State that the attorney general
p.000921: has—
p.000921: (I) reviewed any applicable civil liability protec- tion law to determine the applicability of the law with
p.000921: respect to first responders, health care professionals, family members, and other individuals who—
p.000921: (aa) have received appropriate training in ad- ministering a drug or device approved or cleared under the
p.000921: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (bb) may administer a drug or device ap- proved or cleared under the Federal Food, Drug, and
p.000921: Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (II) concluded that the law described in subclause
p.000921: (I) provides adequate civil liability protection applica- ble to such persons;
p.000921: (B) has a process for enrollment in services and bene- fits necessary by criminal justice agencies to initiate
p.000921: or continue treatment in the community, under which an in- dividual who is incarcerated may, while
p.000921: incarcerated, en- roll in services and benefits that are necessary for the indi- vidual to continue treatment upon
p.000921: release from incarcer- ation;
p.000921: (C) ensures the capability of data sharing with other States, where applicable, such as by making data
p.000921: available to a prescription monitoring hub;
p.000921: (D) ensures that data recorded in the prescription drug monitoring program database of the State are
p.000921: regu- larly updated, to the extent possible;
p.000921: (E) ensures that the prescription drug monitoring pro- gram of the State notifies prescribers and dispensers of
p.000921: schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients
p.000921: is sus- pected; and
p.000921: (F) has in effect one or more statutes or implements policies that maximize use of prescription drug
p.000921: monitoring programs by individuals authorized by the State to pre- scribe schedule II, III, or IV controlled
p.000921: substances.
p.000921: (6) EVALUATION.—In conducting an evaluation of the pro- gram under this section pursuant to section 701
p.000921: of the Com- prehensive Addiction and Recovery Act of 2016, with respect to a State, the Secretary shall report on
p.000921: State legislation or poli- cies related to maximizing the use of prescription drug moni- toring programs and
p.000921: the incidence of opioid use disorders and overdose deaths in such State.
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000921:
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p.000889: such manner, and containing such information as the Secretary may reasonably require, a report, including an
p.000889: evaluation of the effect of such grant on—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: 891
p.000891: PUBLIC HEALTH SERVICE ACT
p.000891: Sec. 520G
p.000891:
p.000891: (1) local crisis response services and measures for individ- uals receiving crisis planning and early
p.000891: intervention supports;
p.000891: (2) individuals reporting improved functional outcomes;
p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
...

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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
p.000891: appropriate, give special consideration to entities proposing to use grant funding to support jail diversion services
p.000891: for veterans.
p.000891: (e) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, or tribal organization that
p.000891: receives a grant under sub- section (a) may use funds received under such grant to—
p.000891: (1) integrate the diversion program into the existing sys- tem of care;
p.000891: (2) create or expand community-based mental health and co-occurring mental illness and substance use disorder
p.000891: services to accommodate the diversion program;
p.000891: (3) train professionals involved in the system of care, and law enforcement officers, attorneys, and judges;
p.000891: (4) provide community outreach and crisis intervention;
p.000891: and
p.000891: (5) develop programs to divert individuals prior to booking
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
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p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891:
p.000891: January 30, 2020
p.000891: or arrest.
p.000891: (f) FEDERAL SHARE.—
p.000891: (1) IN GENERAL.—The Secretary shall pay to a State, polit- ical subdivision of a State, Indian tribe, or tribal
p.000891: organization receiving a grant under subsection (a) the Federal share of the cost of activities described in the
p.000891: application.
p.000891: (2) FEDERAL SHARE.—The Federal share of a grant made under this section shall not exceed 75 percent of the
p.000891: total cost of the program carried out by the State, political subdivision of a State, Indian tribe, or tribal
...

p.000917: device ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000917: suspected opioid overdose;
p.000917: (2) the number of opioid and heroin overdoses reversed by first responders and members of other key community
p.000917: sectors receiving training and supplies of a drug or device approved or cleared under the Federal Food, Drug, and
p.000917: Cosmetic Act for emergency treatment of known or suspected opioid overdose, through a grant received under
p.000917: this section;
p.000917: (3) the number of responses to requests for services by the entity or subgrantee, to opioid and heroin overdose;
p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
p.000917: organization that—
p.000917: (1) mobilizes resources within and outside of the recovery community, which may include through a peer
p.000917: support net- work, to increase the prevalence and quality of long-term re- covery from substance use
p.000917: disorders; and
p.000917: (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community
p.000917: served.
p.000917: (b) GRANTS AUTHORIZED.—The Secretary shall award grants to recovery community organizations to enable such
p.000917: organizations to develop, expand, and enhance recovery services.
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000917:
p.000917:
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p.000917:
p.000917: Sec. 547A PUBLIC HEALTH SERVICE ACT 918
p.000917:
p.000917:
p.000917:
p.000917:
p.000917:
p.000917:
p.000917:
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p.000969: (ii) 3 to otherwise comply with guarantees under this part of loans to nonprofit private agencies;
p.000969: (iii) 3 to make payments of interest subsidies with respect to loans to public agencies which he has made,
p.000969: sold, and guar- anteed under this part;
p.000969: (iv) 3 in the event of default by public agencies to make payments of principal and interest on loans
p.000969: which the Sec- retary has made, sold, and guaranteed, under this part, to make such payments to the
p.000969: purchaser of such loan;
p.000969: (v) 3 to repurchase loans to public agencies which have been sold and guaranteed under this part,
p.000969: he is authorized to issue to the Secretary of the Treasury notes or other obligations in such forms and
p.000969: denominations, bearing such maturities, and subject to such terms and conditions, as may be prescribed by
p.000969: the Secretary with the approval of the Secretary of the Treasury, but only in such amounts as may be
p.000969: specified from time to time in appropriations Acts. Such notes or other obligations shall bear interest at a rate
p.000969: determined by the Secretary of the Treasury, taking into consideration the current average market yield on
p.000969: outstanding marketable obligations of the United States of comparable maturities during the month preceding the
p.000969: issuance of the notes or other obligations. The Secretary of the Treasury is au- thorized and directed to purchase
p.000969: any notes and other obligations issued hereunder and for that purpose he is authorized to use as a
p.000969: public debt transaction the proceeds from the sale of any securi- ties issued under the Second Liberty Bond Act,
p.000969: as amended, and the purposes for which securities may be issued under that Act, as amended, are extended to
p.000969: include any purchase of such notes and obligations. The Secretary of the Treasury may at any time sell any of
p.000969: the notes or other obligations acquired by him under this sub- section. All redemptions, purchases, and
p.000969: sales by the Secretary of the Treasury of such notes or other obligations shall be treated as public debt
p.000969: transactions of the United States. Sums borrowed under this subsection shall be deposited in the
p.000969: fund and redemp- tion of such notes and obligations shall be made by the Secretary from such fund.
p.000969:
p.000969: PROVISIONS APPLICABLE TO LOANS TO PUBLIC FACILITIES
p.000969: SEC. 627. ø291j–7¿ (a)(1) Any loan made by the Secretary to a public agency under this part for the
p.000969: modernization or construc-
p.000969:
p.000969:
p.000969:
p.000969:
p.000969: January 30, 2020
p.000969: 3 Clauses (i) through (v) probably should be redesignated as paragraphs (1) through (5), re- spectively.
p.000969: See section 201 of Public Law 91–296 (84 Stat. 347).
p.000969: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000969:
p.000969:
p.000969:
p.000969:
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p.000969:
p.000969: Sec. 627 PUBLIC HEALTH SERVICE ACT 970
p.000969: tion of a public hospital or other health facility shall require such public agency to pay interest
...

p.001227: money derived from the sale of assets.
p.001227: (2) If at any time the sums in the funds are insufficient to en- able the Secretary to discharge his
p.001227: responsibilities under guaran- tees issued by him before October 1, 1986, under this title and to take
p.001227: the action authorized by subsection (f), he is authorized to issue to the Secretary of the Treasury notes or
p.001227: other obligations in such forms and denominations, bearing such maturities, and sub- ject to such terms and
p.001227: conditions, as may be prescribed by the Sec- retary with the approval of the Secretary of Treasury. Such
p.001227: notes or other obligations shall bear interest at a rate determined by the
p.001227: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001227:
p.001227:
p.001227:
p.001227:
p.001227:
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p.001227:
p.001227:
p.001229: 1229
p.001229: PUBLIC HEALTH SERVICE ACT
p.001229: Sec. 1310
p.001229:
p.001229: Secretary of the Treasury, taking into consideration the current av- erage market yield on outstanding marketable
p.001229: obligations of the United States of comparable maturities during the month pre- ceding the issuance of the
p.001229: notes or other obligations. The Secretary of the Treasury shall purchase any notes and other obligations
p.001229: issued under this paragraph and for that purpose he may use as a public debt transaction the proceeds from
p.001229: the sale of any securi- ties issued under the Second Liberty Bond Act, and the purposes for which the
p.001229: securities may be issued under that Act are extended to include any purchase of such notes and obligations.
p.001229: The Sec- retary of the Treasury may at any time sell any of the notes or other obligations acquired by
p.001229: him under this paragraph. All re- demptions, purchases, and sales by the Secretary of the Treasury of
p.001229: such notes or other obligations shall be treated as public debt transactions of the United States. Sums
p.001229: borrowed under this para- graph shall be deposited in the fund and redemption of such notes and obligations shall be
p.001229: made by the Secretary from the fund.
p.001229: (e) There is established in the Treasury a loan fund (herein- after in this subsection referred to as
p.001229: the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts
p.001229: as may be specified from time to time in appropriation Acts, to enable him to make loans under this title and
p.001229: to take the action authorized by subsection (f). There shall also be deposited in the fund amounts received by the
p.001229: Secretary as interest payments and repayment of principal on loans made under this title and other
p.001229: property or assets derived by him from his operations re- specting such loans, from the sale of loans
p.001229: under subsection (c) of this section, or from the sale of assets.
p.001229: (f) The Secretary may take such action as he deems appro- priate to protect the interest of the United
p.001229: States in the event of a default on a loan made or guaranteed under this title, including taking possession of,
...

p.001251: payments of principal and interest on such loan after default by the entity to which the loan was made, or
p.001251: (D) to repurchase loans under subsection (c)(3)(B),
p.001251: (E) to make payments of interest on loans which are sold and guaranteed, and
p.001251: (F) to enable the Secretary to take the action authorized by subsection (f),
p.001251: he is authorized to issue to the Secretary of the Treasury notes or other obligations in such forms and
p.001251: denominations bearing such maturities, and subject to such terms and conditions, as may be prescribed by
p.001251: the Secretary with the approval of the Secretary of the Treasury. Such notes or other obligations shall bear
p.001251: interest at a rate determined by the Secretary of the Treasury, taking into consideration the current
p.001251: average market yield on outstanding marketable obligations of the United States of comparable matu- rities
p.001251: during the month preceding the issuance of the notes or other
p.001251: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001251:
p.001251:
p.001251:
p.001251:
p.001251:
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p.001251:
p.001251: Sec. 1610 PUBLIC HEALTH SERVICE ACT 1252
p.001251:
p.001251: obligations. The Secretary of the Treasury shall purchase any notes and other obligations issued under this paragraph
p.001251: and for that pur- pose he may use as a public debt transaction the proceeds from the sale of any securities issued
p.001251: under the Second Liberty Bond Act, and the purposes for which the securities may be issued under that Act are
p.001251: extended to include any purchase of such notes and obliga- tions. The Secretary of the Treasury may at any
p.001251: time sell any of the notes or other obligations acquired by him under this para- graph. All redemptions,
p.001251: purchases, and sales by the Secretary of the Treasury of such notes or other obligations shall be treated as
p.001251: public debt transactions of the United States. Sums borrowed under this paragraph shall be
p.001251: deposited in the fund and redemp- tion of such notes and obligations shall be made by the Secretary
p.001251: from the fund.
p.001251: (e)(1) The assets, commitments, obligations, and outstanding
p.001251: balances of the loan guarantee and loan fund established in the Treasury by section 626 shall be
p.001251: transferred to the fund estab- lished by subsection (d) of this section.
p.001251: (2) To provide additional capitalization for the fund established under subsection (d) there are authorized to be
p.001251: appropriated to the fund, such sums as may be necessary for the fiscal years ending June 30, 1975, June
p.001251: 30, 1976, September 30, 1977, September 30, 1978, September 30, 1979, September 30, 1980, September 30,
p.001251: 1981, and September 30, 1982.
p.001251: (f)(1) The Secretary may take such action as may be necessary to prevent a default on a loan made or guaranteed under
p.001251: this part or under title VI, including the waiver of regulatory conditions, de- ferral of loan payments, renegotiation
p.001251: of loans, and the expenditure of funds for technical and consultative assistance, for the tem- porary payment
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Searching for indicator prison:

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p.000255: (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service
p.000255: Commission for the purpose of promoting health and efficiency;
p.000255: (3) seamen for purposes of qualifying for certificates of service; and
p.000255: (4) employees eligible for benefits under the Longshore- men’s and Harbor Workers’ Compensation Act, as
p.000255: amended (U.S.C. 1940 edition, title 33, chapter 18), 30 as requested by any deputy commissioner thereunder.
p.000255: (b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and
p.000255: optometric care for Federal employees (as defined in section 8901(1) of title 5 of the United States
p.000255: Code) and their dependents at remote medical facili- ties of the Public Health Service where such care and
p.000255: treatment are not otherwise available. Such employees and their dependents who are not entitled to this
p.000255: care and treatment under any other provision of law shall be charged for it at rates established by the
p.000255:
p.000255:
p.000255:
p.000255:
p.000255:
p.000255:
p.000255:
p.000255:
p.000255:
p.000255: January 30, 2020
p.000255: 27 Title I of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies
p.000255: Appropriations Act, 2005 (as contained in division B of Public Law 108–447) provided that of the amounts appropriated
p.000255: for salaries and expenses regarding the Federal Prison System ‘‘the Attorney General may transfer to the Health
p.000255: Resources and Services Administration such amounts as may be necessary for direct expenditures by that
p.000255: Administration for medical relief for inmates of Federal penal and correctional institutions’’. (See 118 Stat.
p.000255: 2860.) Similar provi- sions have appeared in the analogous appropriations Act of many prior years. See section 250a of
p.000255: title 42, United States Code, and the notes following such section.
p.000255: 28 Now codified to section 4005 of title 18, United States Code.
p.000255: 29 Codified to chapter 81 of title 5, United States Code.
p.000255: 30 Codification remains chapter 18 of title 33, United States Code.
p.000255: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000255:
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p.000255: Sec. 325 PUBLIC HEALTH SERVICE ACT 256
p.000255:
p.000255: Secretary to reflect the reasonable cost of providing the care and treatment. Any payments pursuant to the
p.000255: preceding sentence shall be credited to the applicable appropriation to the Public Health Service for the year
p.000255: in which such payments are received.
p.000255: EXAMINATION OF ALIENS
p.000255: SEC. 325. ø252¿ The Surgeon General shall provide for mak- ing, at places within the United States or
p.000255: in other countries, such physical and mental examinations of aliens as are required by the immigration laws,
p.000255: subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the
...

p.000917: device ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000917: suspected opioid overdose;
p.000917: (2) the number of opioid and heroin overdoses reversed by first responders and members of other key community
p.000917: sectors receiving training and supplies of a drug or device approved or cleared under the Federal Food, Drug, and
p.000917: Cosmetic Act for emergency treatment of known or suspected opioid overdose, through a grant received under
p.000917: this section;
p.000917: (3) the number of responses to requests for services by the entity or subgrantee, to opioid and heroin overdose;
p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
p.000917: organization that—
p.000917: (1) mobilizes resources within and outside of the recovery community, which may include through a peer
p.000917: support net- work, to increase the prevalence and quality of long-term re- covery from substance use
p.000917: disorders; and
p.000917: (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community
p.000917: served.
p.000917: (b) GRANTS AUTHORIZED.—The Secretary shall award grants to recovery community organizations to enable such
p.000917: organizations to develop, expand, and enhance recovery services.
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000917:
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p.000001: be made by the President. Each permanent pro- motion shall be to the next higher grade, and shall be
p.000001: made only
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 210 PUBLIC HEALTH SERVICE ACT 14
p.000001:
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p.000001: January 30, 2020
p.000001:
p.000001: after examination given in accordance with regulations of the President.
p.000001: (b) The President may by regulation provide that in a specified professional category permanent promotions to the
p.000001: senior grade, or to both the full grade and the senior grade, shall be made only if there are vacancies in
p.000001: such grade. A grade in any category with re- spect to which such regulations have been issued is referred to
p.000001: in this section as a ‘‘restricted grade’’.
p.000001: (c) Examinations to determine qualification for permanent pro- motions may be either noncompetitive or
p.000001: competitive, as the Sur- geon General shall in each case determine; except that examina- tions for
p.000001: promotions to the assistant or senior assistant grade shall in all cases be noncompetitive. The officers to be examined
p.000001: shall be selected by the Surgeon General from the professional category, and in the order of seniority in
p.000001: the grade, from which promotion is to be recommended. In the case of a competitive examination the Surgeon
p.000001: General shall determine in advance of the examination the number (which may be one or more) of officers who,
p.000001: after pass- ing the examination, will be recommended to the President for pro- motion; but if the examination is
p.000001: one for promotions based on length of service, or is one for promotions to fill vacancies other than
p.000001: vacancies in the director grade or in a restricted grade, such number shall not be less than 80 per centum of
p.000001: the number of offi- cers to be examined.
p.000001: (d) Officers of the Regular Corps, found pursuant to subsection
p.000001: (c) to be qualified, shall be given permanent promotions based on length of service, as follows:
p.000001: (1) Officers in the warrant officer (W–1) grade, chief warrant officer (W–2) grade, chief warrant officer
p.000001: (W–3) grade, chief war- rant officer (W–4) grade, and junior assistant grade shall be pro- moted at
p.000001: such times as may be prescribed in regulations of the President.
p.000001: (2) Officers with permanent rank in the assistant grade, the senior assistant grade, and the full grade shall
p.000001: (except as provided in regulations under subsection (b)) be promoted after completion of three, ten, and
p.000001: seventeen years, respectively, of service in grades above the junior assistant grade; and such promotions, when made,
p.000001: shall be effective, for purposes of pay and seniority in grade, as of the day following the completion of such years of
p.000001: service. An officer with permanent rank in the assistant, senior assistant, or full grade who has not
p.000001: completed such years of service shall be pro- moted at the same time, and his promotion shall be effective as of
p.000001: the same day, as any officer junior to him in the same grade in the same professional category who is promoted under
p.000001: this paragraph.
p.000001: (e) Officers in a professional category of the Regular Corps, found pursuant to subsection (c) to be
p.000001: qualified may be given per- manent promotions to fill any or all vacancies in such category in the
p.000001: senior assistant grade, the full grade, the senior grade, or the director grade; but no officer who has
p.000001: not had one year of service with permanent or temporary rank in the next lower grade shall be promoted
p.000001: to any restricted grade or to the director grade.
p.000001: (f) If an officer who has completed the years of service required for promotion to a grade under paragraph (2) of
p.000001: subsection (d) fails to receive such promotion, he shall (unless he has already been
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 15 PUBLIC HEALTH SERVICE ACT Sec. 210
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p.000001: January 30, 2020
p.000001: twice examined for promotion to such grade) be once reexamined for promotion to such grade. If he is thereupon
p.000001: promoted (otherwise than under subsection (e)), the effective date of such promotion shall be one year later
p.000001: than it would have been but for such failure. Upon the effective date of any permanent promotion of such officer to
p.000001: such grade, he shall be considered as having had only the length of service required for such promotion which he
p.000001: previously failed to receive.
p.000001: (g) If, for reasons other than physical disability, an officer of the Regular Corps in the warrant officer
p.000001: (W–1) grade or junior as- sistant grade is found pursuant to subsection (c) not to be qualified for promotion he shall
p.000001: be separated from the Service. If, for reasons other than physical disability, an officer of the Regular Corps
p.000001: in the chief warrant officer (W–2), chief warrant officer (W–3), assist- ant, senior assistant, or full grade,
p.000001: after having been twice exam- ined for promotion (other than promotion to a restricted grade), fails to be
p.000001: promoted—
p.000001: (1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the Service and paid
p.000001: six months’ basic pay and allowances;
p.000001: (2) if in the chief warrant officer (W–3) or senior assistant grade he shall be separated from the Service and
p.000001: paid one year’s basic pay and allowances;
p.000001: (3) if in the full grade he shall be considered as not in line for promotion and shall, at such time thereafter as the
p.000001: Surgeon General may determine, be retired from the Service with re- tired pay (unless he is entitled to
p.000001: a greater amount by reason of another provision of law)—
p.000001: (A) in the case of an officer who first became a mem- ber of a uniformed service before September 8, 1980,
p.000001: at the rate of 21⁄2 percent of the retired pay base determined under section 1406(h) of title 10, United
p.000001: States Code, for each year, not in excess of 30, of his active commissioned service in the Service; or
p.000001: (B) in the case of an officer who first became a mem- ber of a uniformed service on or after
p.000001: September 8, 1980, at the rate determined by multiplying—
p.000001: (i) the retired pay base determined under section 1407 of title 10, United States Code; by
p.000001: (ii) the retired pay multiplier determined under section 1409 of such title for the number of years of
p.000001: his active commissioned service in the Service.
...

p.000017:
p.000017: statistical activities within States participating in the system 4 produce uniform and timely data and assure
p.000017: appropriate access to such data.
p.000017: (f) To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate
p.000017: and consult with the Depart- ments of Commerce and Labor and any other interested Federal departments or
p.000017: agencies and with State and local health depart- ments and agencies. For such purpose he shall utilize
p.000017: insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to
p.000017: section 3709 of the Revised Stat- utes (41 U.S.C. 5), of any appropriate State or other public agency, and may,
p.000017: without regard to such section, utilize the services or fa- cilities of any private agency, organization, group, or
p.000017: individual, in accordance with written agreements between the head of such agency, organization, or group
p.000017: and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities
p.000017: shall be made in such amounts as may be provided in such agreement.
p.000017: (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health
p.000017: data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation
p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
p.000017: necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data
p.000017: on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific
p.000017: Islanders with significant representation in the State or registration area. Each State or registration area shall
p.000017: be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and
p.000017: transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such
p.000017: data.
p.000017: (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general
p.000017: health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to
p.000017: be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and
p.000017: accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations,
p.000017: and the relationship between de- mographic and socioeconomic characteristics and health character- istics.
p.000017: (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use
p.000017: in such activities of statistics collected or compiled by the Center.
...

p.000219: State may establish, enforce, or continue in effect with respect to a covered counter- measure any provision of law or
p.000219: legal requirement that—
p.000219: (A) is different from, or is in conflict with, any require- ment applicable under this section; and
p.000219: (B) relates to the design, development, clinical testing or investigation, formulation, manufacture,
p.000219: distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other
p.000219: aspect of safety or effi- cacy, or the prescribing, dispensing, or administration by qualified persons of
p.000219: the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under
p.000219: this section or any other provision of this Act, or under the Federal Food, Drug, and Cosmetic Act.
p.000219: (9) REPORT TO CONGRESS.—Within 30 days after making a declaration under paragraph (1), the Secretary shall submit to
p.000219: the appropriate committees of the Congress a report that pro- vides an explanation of the reasons for issuing
p.000219: the declaration and the reasons underlying the determinations of the Sec- retary with respect to paragraph
p.000219: (2). Within 30 days after making an amendment under paragraph (4), the Secretary shall submit to such
p.000219: committees a report that provides the rea- sons underlying the determination of the Secretary to make the
p.000219: amendment.
p.000219: (c) DEFINITION OF WILLFUL MISCONDUCT.—
p.000219: (1) DEFINITION.—
p.000219: (A) IN GENERAL.—Except as the meaning of such term is further restricted pursuant to paragraph (2), the term
p.000219: ‘‘willful misconduct’’ shall, for purposes of subsection (d), denote an act or omission that is taken—
p.000219: (i) intentionally to achieve a wrongful purpose;
p.000219: (ii) knowingly without legal or factual justifica- tion; and
p.000219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000219:
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p.000221: 221
p.000221: PUBLIC HEALTH SERVICE ACT
p.000221: Sec. 319F–3
p.000221:
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p.000221: January 30, 2020
p.000221: (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that
p.000221: the harm will outweigh the benefit.
p.000221: (B) RULE OF CONSTRUCTION.—The criterion stated in subparagraph (A) shall be construed as establishing
...

p.000403: General, promptly after first determining that the individ- uals need access under subparagraph (A), and periodically
p.000403: thereafter while the individuals have such access, not less frequently than once every five years;
p.000403: (C) deny access to such agents and toxins by individ- uals whom the Attorney General has identified as
p.000403: re- stricted persons; and
p.000403: (D) limit or deny access to such agents and toxins by individuals whom the Attorney General has
p.000403: identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the
p.000403: individuals involved is deter- mined appropriate by the Secretary, in consultation with the Attorney General.
p.000403: (3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.—
p.000403: (A) IN GENERAL.—Upon the receipt of names and other identifying information under paragraph (2)(B), the Attor-
p.000403: ney General shall, for the sole purpose of identifying whether the individuals involved are within any
p.000403: of the cat- egories specified in subparagraph (B), promptly use crimi- nal, immigration, national security, and
p.000403: other electronic databases that are available to the Federal Government and are appropriate for such purpose.
p.000403: (B) CERTAIN INDIVIDUALS.—For purposes of subpara- graph (A), the categories specified in this subparagraph re-
p.000403: garding an individual are that—
p.000403: (i) the individual is a restricted person; or
p.000403: (ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
p.000403: (I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;
p.000403: (II) knowing involvement with an organiza- tion that engages in domestic or international ter- rorism (as defined
p.000403: in section 2331 of such title 18) or with any other organization that engages in in- tentional crimes of violence; or
p.000403: (III) being an agent of a foreign power (as de- fined in section 1801 of title 50, United States Code).
p.000403: (C) NOTIFICATION BY ATTORNEY GENERAL REGARDING SUBMITTED NAMES.—After the receipt of a name and other
p.000403: identifying information under paragraph (2)(B), the Attor- ney General shall promptly notify the Secretary
p.000403: whether the individual is within any of the categories specified in subparagraph (B).
p.000403: (4) NOTIFICATIONS BY SECRETARY.—The Secretary, after re- ceiving notice under paragraph (3) regarding an
p.000403: individual, shall promptly notify the registered person involved of whether the individual is granted or denied access
p.000403: under paragraph (2).
p.000403: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000403:
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p.000405: 405
p.000405: PUBLIC HEALTH SERVICE ACT
p.000405: Sec. 351A
p.000405:
p.000405:
p.000405:
p.000405:
p.000405:
p.000405:
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p.000405: upon re- quest to the Secretary by a registered person who submits names and other identifying
p.000405: information under paragraph (2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by
p.000405: the Secretary—
p.000405: (A) request the Attorney General to expedite the proc- ess of identification under paragraph (3)(A) and
p.000405: notifica- tion of the Secretary under paragraph (3)(C); and
p.000405: (B) expedite the notification of the registered person by the Secretary under paragraph (4).
p.000405: (6) PROCESS REGARDING PERSONS SEEKING TO REGISTER.—
p.000405: (A) INDIVIDUALS.—Regulations under subsections (b) and (c) shall provide that an individual who seeks to
p.000405: reg- ister under either of such subsections is subject to the same processes described in paragraphs (2)
p.000405: through (4) as apply to names and other identifying information sub- mitted to the Attorney General under
p.000405: paragraph (2)(B). Paragraph (5) does not apply for purposes of this subpara- graph.
p.000405: (B) OTHER PERSONS.—Regulations under subsections
p.000405: (b) and (c) shall provide that, in determining whether to deny or revoke registration by a person other than
p.000405: an indi- vidual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal,
p.000405: immigra- tion, national security, and other electronic databases available to the Federal Government,
p.000405: as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the
p.000405: individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law
p.000405: enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied
p.000405: to persons, including individuals). Such regulations shall provide that a person who seeks to register under
p.000405: either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply
p.000405: to names and other identifying information sub- mitted to the Attorney General under paragraph (2)(B).
p.000405: Paragraph (5) does not apply for purposes of this subpara- graph. The Secretary may exempt Federal, State, or
p.000405: local governmental agencies from the requirements of this sub- paragraph.
p.000405: (7) REVIEW.—
p.000405: (A) ADMINISTRATIVE REVIEW.—
p.000405: (i) IN GENERAL.—Regulations under subsections
p.000405: (b) and (c) shall provide for an opportunity for a re- view by the Secretary—
p.000405: (I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual
p.000405: access to listed agents and toxins; and
p.000405: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000405:
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p.000405: Sec. 351A PUBLIC HEALTH SERVICE ACT 406
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p.000405: appeal and expedited consider- ation).
p.000405: (ii) DISCLOSURE OF INFORMATION.—In a review under subparagraph (A), and in any judical proceeding conducted
p.000405: pursuant to such review, neither the Sec- retary nor the Attorney General may be required to disclose to
p.000405: the public any information that under sub- section (h) shall not be disclosed under section 552 of title 5,
p.000405: United States Code.
p.000405: (8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.— Requirements under paragraph (1) shall include the
p.000405: prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the
p.000405: theft or loss of listed agents and toxins.
p.000405: (9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The Secretary, in consultation with the Attorney General, may pro-
p.000405: vide technical assistance to registered persons to improve secu- rity of the facilities of such persons.
p.000405: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000407: 407
p.000407: PUBLIC HEALTH SERVICE ACT
p.000407: Sec. 351A
p.000407:
p.000407: (f) INSPECTIONS.—The Secretary shall have the authority to in- spect persons subject to regulations under
p.000407: subsection (b) or (c) to ensure their compliance with such regulations, including prohibi- tions on
p.000407: restricted persons and other provisions of subsection (e).
p.000407: (g) EXEMPTIONS.—
p.000407: (1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations under subsections (b) and (c) shall exempt clinical or
p.000407: diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are
p.000407: contained in specimens pre- sented for diagnosis, verification, or proficiency testing, pro- vided that—
p.000407: (A) the identification of such agents or toxins is re- ported to the Secretary, and when required under
p.000407: Federal,
p.000407: State, or local law, to other appropriate authorities; and
p.000407: (B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.
p.000407: (2) PRODUCTS.—
p.000407: (A) IN GENERAL.—Regulations under subsections (b) and (c) shall exempt products that are, bear, or
p.000407: contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts
p.000407: specified in subpara- graph (B), unless the Secretary by order determines that applying additional
p.000407: regulation under subsection (b) or (c) to a specific product is necessary to protect public health and
p.000407: safety.
p.000407: (B) RELEVANT LAWS.—For purposes of subparagraph (A), the Acts specified in this subparagraph are the fol-
p.000407: lowing:
p.000407:
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p.000407: January 30, 2020
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p.000411: annually following the submission of the report under subparagraph
p.000411: (A) until the recommendations described in such subpara- graph are fully implemented, or a justification is
p.000411: provided for the delay in, or lack of, implementation.
p.000411: (l) DEFINITIONS.—For purposes of this section:
p.000411: (1) The terms ‘‘biological agent’’ and ‘‘toxin’’ have the meanings given such terms in section
p.000411: 178 of title 18, United States Code.
p.000411: (2) The term ‘‘listed agents and toxins’’ means biological agents and toxins listed pursuant to subsection
p.000411: (a)(1).
p.000411: (3) The term ‘‘listed agents or toxins’’ means biological agents or toxins listed pursuant to subsection
p.000411: (a)(1).
p.000411: (4) The term ‘‘overlap agents and toxins’’ means biological agents and toxins that—
p.000411: (A) are listed pursuant to subsection (a)(1); and
p.000411: (B) are listed pursuant to section 212(a)(1) of the Agri- cultural Bioterrorism Protection Act of 2002.
p.000411: (5) The term ‘‘overlap agent or toxin’’ means a biological agent or toxin that—
p.000411: (A) is listed pursuant to subsection (a)(1); and
p.000411: (B) is listed pursuant to section 212(a)(1) of the Agri- cultural Bioterrorism Protection Act of 2002.
p.000411: (6) The term ‘‘person’’ includes Federal, State, and local governmental entities.
p.000411: (7) The term ‘‘registered person’’ means a person registered under regulations under subsection (b) or (c).
p.000411: (8) The term ‘‘restricted person’’ has the meaning given such term in section 175b of title 18, United States
p.000411: Code.
p.000411: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000411: to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2007.
p.000411: PREPARATION OF BIOLOGICAL PRODUCTS
p.000411: SEC. 352. ø263¿ (a) The Service may prepare for its own use any product described in section 351 and any
p.000411: product necessary to carrying out any of the purposes of section 301.
p.000411: (b) The Service may prepare any product described in section 351 for the use of other Federal departments or
p.000411: agencies, and pub- lic or private agencies and individuals engaged in work in the field of medicine when such product
p.000411: is not available from establishments licensed under such section.
p.000411: Subpart 2—Clinical Laboratories
p.000411:
p.000411:
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p.000411:
p.000411: January 30, 2020
p.000411:
p.000411: CERTIFICATION OF LABORATORIES
p.000411: SEC. 353. ø263a¿ (a) DEFINITION.—As used in this section, the term ‘‘laboratory’’ or ‘‘clinical laboratory’’ means a
p.000411: facility for the bi- ological, microbiological, serological, chemical, immuno- hematological,
p.000411: hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body
p.000411: for
p.000411: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001559: information concerning—
p.001559: (A) the provisions of such coverage concerning issuer’s right to change premium rates and the factors that may
p.001559: affect changes in premium rates; and
p.001559: (B) the benefits and premiums available under all health insurance coverage for which the employer, or indi-
p.001559: vidual, as applicable, is qualified.
p.001559: (2) FORM OF INFORMATION.—Information under this sub- section shall be provided to employers, or individuals, as
p.001559: appli- cable, in a manner determined to be understandable by the av- erage employer, or individual, as applicable,, 7
p.001559: and shall be suf- ficient to reasonably inform employers, or individuals, as appli- cable, of their rights and
p.001559: obligations under the health insur- ance coverage.
p.001559: (3) EXCEPTION.—An issuer is not required under this sec- tion to disclose any information that is
p.001559: proprietary and trade secret information under applicable law.
p.001559: Subpart II—Improving Coverage 8
p.001559: SEC. 2711. ø300gg–11¿ NO LIFETIME OR ANNUAL LIMITS.
p.001559: (a) PROHIBITION.—
p.001559: (1) IN GENERAL.—A group health plan and a health insur- ance issuer offering group or individual health
p.001559: insurance cov- erage may not establish—
p.001559: (A) lifetime limits on the dollar value of benefits for any participant or beneficiary; or
p.001559: (B) except as provided in paragraph (2), annual limits on the dollar value of benefits for any participant or bene-
p.001559: ficiary.
p.001559: (2) ANNUAL LIMITS PRIOR TO 2014.—With respect to plan years beginning prior to January 1, 2014, a group health
p.001559: plan and a health insurance issuer offering group or individual health insurance coverage may only
p.001559: establish a restricted an- nual limit on the dollar value of benefits for any participant or beneficiary with
p.001559: respect to the scope of benefits that are essen- tial health benefits under section 1302(b) of the Patient Protec- tion
p.001559: and Affordable Care Act, as determined by the Secretary. In defining the term ‘‘restricted annual limit’’ for
p.001559: purposes of the preceding sentence, the Secretary shall ensure that access to needed services is made
p.001559: available with a minimal impact on premiums.
p.001559:
p.001559:
p.001559:
p.001559: January 30, 2020
p.001559: 8 There is a subpart 2 (arabic 2) beginning with section 2722.
p.001559: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001559:
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p.001561: PUBLIC HEALTH SERVICE ACT
p.001561: Sec. 2713
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p.001561: (b) PER BENEFICIARY LIMITS.—Subsection (a) shall not be con- strued to prevent a group health plan or health
p.001561: insurance coverage from placing annual or lifetime per beneficiary limits on specific covered benefits that
p.001561: are not essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act, to
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p.000017: reduce the time it takes to comply with the requirements of this subsection.
p.000017: (2) The Secretary shall coordinate with the heads of other ap- plicable Federal agencies to ensure that
p.000017: such departments have policies in place with respect to the issuance of a certificate of con- fidentiality pursuant
p.000017: to paragraph (1) and other requirements of this subsection.
p.000017: (3) Nothing in this subsection shall be construed to limit the access of an individual who is a subject of
p.000017: research to information about himself or herself collected during such individual’s partici- pation in the
p.000017: research.
p.000017: (4) For purposes of this subsection, the term ‘‘identifiable, sen- sitive information’’ means information that is
p.000017: about an individual and that is gathered or used during the course of research de- scribed in paragraph
p.000017: (1)(A) and—
p.000017: (A) through which an individual is identified; or
p.000017: (B) for which there is at least a very small risk, as deter- mined by current scientific practices or
p.000017: statistical methods, that some combination of the information, a request for the in- formation, and other available
p.000017: data sources could be used to deduce the identity of an individual.
p.000017: (e) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.000017: expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Pre- vention with
p.000017: respect to preterm labor and delivery and infant mor- tality.
p.000017: (f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical
p.000017: information that is about an individual and that is gathered or used during the course of biomedical
p.000017: research if—
p.000017: (A) an individual is identified; or
p.000017: (B) there is at least a very small risk, as determined by current scientific practices or statistical
p.000017: methods, that some combination of the information, the request, and other avail- able data sources could be
p.000017: used to deduce the identity of an in- dividual.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 77 PUBLIC HEALTH SERVICE ACT Sec. 302
p.000017:
p.000017: (2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in
p.000017: writing and accompanied by a statement of the basis for the determination.
p.000017: (B) Each such determination and statement of basis shall be available to the public, upon request,
p.000017: through the Office of the Chief FOIA Officer of the Department of Health and Human Serv- ices.
p.000017: (3) Nothing in this subsection shall be construed to limit a re- search participant’s access to information about
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p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
p.000017: statistical and (where appropriate) epidemiological activities, and the research, evalua- tions, and
p.000017: demonstrations respecting the assessment of health care technology authorized by this Act through the Agency
p.000017: for Health Care Policy and Research and the National Center for Health Sta- tistics.
p.000017:
p.000017: NATIONAL CENTER FOR HEALTH STATISTICS
p.000017: SEC. 306. 3 ø242k¿ (a) There is established in the Department of Health and Human Services the National Center
p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
p.000017: acute and chronic ill- nesses, and infant and maternal morbidity and mortality,
p.000017: (B) the impact of illness and disability of the popu- lation on the economy of the United States and
p.000017: on other aspects of the well-being of its population (or of such groupings),
p.000017: (C) environmental, social, and other health hazards,
p.000017: (D) determinants of health,
p.000017: (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty
p.000017: and type of practice and the supply of services by hospitals, ex- tended care facilities, home health agencies,
p.000017: and other health institutions,
p.000017: (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types
p.000017: of practice of the health professionals providing such serv- ices, and (ii) services of hospitals,
p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
p.000017:
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p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111:
p.000111: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000111: pay- ments under the award involved by an amount equal to the costs of detailing personnel and the
p.000111: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall,
p.000111: for the payment of ex- penses incurred in complying with such request, expend the amounts withheld.
p.000111: (3) APPLICATION FOR AWARD.—The Secretary may make an award of a grant or contract under paragraph (1) only if an ap-
p.000111: plication for the award is submitted to the Secretary and the application is in such form, is made in such
p.000111: manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to
p.000111: carry out the purposes for which the award is to be made.
p.000111: (c) BIENNIAL REPORT.—Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the
p.000111: Secretary shall submit to the Committee on Commerce of the House of Representa- tives, and the Committee on Labor
p.000111: and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
p.000111: (1) contains information regarding the incidence and prev- alence of birth defects, developmental
p.000111: disabilities, and the health status of individuals with disabilities and the extent to which these conditions
p.000111: have contributed to the incidence and prevalence of infant mortality and affected quality of life;
p.000111: (2) contains information under paragraph (1) that is spe- cific to various racial and ethnic groups
p.000111: (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
p.000111: (3) contains an assessment of the extent to which various approaches of preventing birth defects,
p.000111: developmental disabil- ities, and secondary health conditions among individuals with disabilities have been
p.000111: effective;
p.000111: (4) describes the activities carried out under this section;
p.000111: (5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or
p.000111: develop- mental disabilities, information on the health status of individ- uals with disabilities, information on any
p.000111: health disparities ex- perienced by such individuals, and recommendations for im- proving the health and
p.000111: wellness and quality of life of such indi- viduals;
p.000111: (6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Dis-
p.000111: ease Control and Prevention, including conferences related to spina bifida; and
p.000111: (7) contains any recommendations of the Secretary regard- ing this section.
p.000111: (d) APPLICABILITY OF PRIVACY LAWS.—The provisions of this section shall be subject to the requirements of
p.000111: section 552a of title 5, United States Code. All Federal laws relating to the privacy of information shall
p.000111: apply to the data and information that is col- lected under this section.
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p.000127: ical coroners; and
p.000127: (iv) other appropriate individuals or entities; and
p.000127: (B) provides for voluntary and confidential case report- ing of pregnancy-associated deaths and pregnancy-related
p.000127: deaths to the appropriate State or tribal health agency by family members of the deceased, and other appropriate in-
p.000127: dividuals, for purposes of review by the applicable mater- nal mortality review committee; and
p.000127: (C) shall include—
p.000127: (i) making publicly available contact information of the committee for use in such reporting; and
p.000127: (ii) conducting outreach to local professional orga- nizations, community organizations, and social serv- ices
p.000127: agencies regarding the availability of the review committee.
p.000127: (3) DATA COLLECTION AND REVIEW.—States, Indian tribes, and tribal organizations that participate in
p.000127: the program de- scribed in this subsection shall—
p.000127: (A) annually identify pregnancy-associated deaths and pregnancy-related deaths—
p.000127: (i) through the appropriate vital statistics unit by—
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p.000127: (I) matching each death record related to a pregnancy-associated death or pregnancy-related death in the
p.000127: State or tribal area in the applicable year to a birth certificate of an infant or fetal death record, as
p.000127: applicable;
p.000127: (II) to the extent practicable, identifying an underlying or contributing cause of each preg-
p.000127: nancy-associated death and each pregnancy-re- lated death in the State or tribal area in the ap-
p.000127: plicable year; and
p.000127: (III) collecting data from medical examiner and coroner reports, as appropriate;
p.000127: (ii) using other appropriate methods or informa- tion to identify pregnancy-associated deaths and preg-
p.000127: nancy-related deaths, including deaths from pregnancy outcomes not identified through clause (i)(I);
p.000127: (B) through the maternal mortality review committee, review data and information to identify adverse outcomes
p.000127: that may contribute to pregnancy-associated death and pregnancy-related death, and to identify trends,
p.000127: patterns, and disparities in such adverse outcomes to allow the State, Indian tribe, or tribal
p.000127: organization to make rec- ommendations to individuals and entities described in paragraph (2)(A), as
p.000127: appropriate, to improve maternal care and reduce pregnancy-associated death and pregnancy-re- lated death;
p.000127: (C) identify training available to the individuals and entities described in paragraph (2)(A) for accurate
p.000127: identi- fication and reporting of pregnancy-associated and preg- nancy-related deaths;
p.000127: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000129: PUBLIC HEALTH SERVICE ACT
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p.000263: award of funding to an additional health center in the area can be justified based on the unmet need for
p.000263: additional services within the catchment area.
p.000263: (B) APPROVAL OF EXPANDED SERVICE APPLICATIONS.—
p.000263: (i) IN GENERAL.—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph
p.000263: (1) to expand the capacity of the applicant to provide required primary health services described in
p.000263: subsection (b)(1) or additional health services de- scribed in subsection (b)(2).
p.000263: (ii) PRIORITY EXPANSION PROJECTS.—In carrying out clause (i), the Secretary may give special consider- ation to
p.000263: expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health,
p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
p.000263: providing serv- ices to any medically underserved population among which there is a substantial incidence
p.000263: of infant mortality or among which there is a significant increase in the incidence of infant mortality.
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
p.000265:
p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
p.000265: (B) such services will be continuous for each such re- cipient;
p.000265: (C) the center will provide follow-up services for indi- viduals who are referred by the center for
p.000265: services de- scribed in paragraph (1);
p.000265: (D) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health
p.000265: services (including prenatal care) with respect to the pur- pose described in this subsection; and
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p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000283: Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access
p.000283: to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others
p.000283: residing in medically underserved areas.
p.000283: (2) APPLICATION FOR GRANT.—A grant may not be awarded under paragraph (1) unless an application therefore is
p.000283: sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted
p.000283: in such form and manner and shall contain such information as the Secretary may prescribe.
p.000283: (c) DEFINITIONS.—For purposes of this section:
p.000283: (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive
p.000283: electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may
p.000283: revise the definition of such term to the extent the Secretary determines necessary.
p.000283: (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6).
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000283: SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
p.000283: (a) INFANT ADOPTION AWARENESS.—
p.000283: (1) IN GENERAL.—The Secretary shall make grants to na- tional, regional, or local adoption organizations for
p.000283: the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers
p.000283: in providing adoption in- formation and referrals to pregnant women on an equal basis with all other
p.000283: courses of action included in nondirective coun- seling to pregnant women.
p.000283: (2) BEST-PRACTICES GUIDELINES.—
p.000283: (A) IN GENERAL.—A condition for the receipt of a grant under paragraph (1) is that the adoption organization
p.000283: in- volved agree that, in providing training under such para- graph, the organization will follow the
p.000283: guidelines devel- oped under subparagraph (B).
p.000283: (B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
p.000283: (i) IN GENERAL.—The Secretary shall establish and supervise a process described in clause (ii) in
p.000283: which the participants are—
p.000283: (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise
p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
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p.000287: only if an applica- tion for the award is submitted to the Secretary and the applica-
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: PUBLIC HEALTH SERVICE ACT
p.000289: Sec. 330H
p.000289:
p.000289: tion is in such form, is made in such manner, and contains such agreements, assurances, and information
p.000289: as the Secretary deter- mines to be necessary to carry out this section.
p.000289: (e) FUNDING.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as
p.000289: may be nec- essary for each of the fiscal years 2001 through 2005.
p.000289: SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
p.000289: (a) IN GENERAL.—
p.000289: (1) CONTINUATION AND EXPANSION OF PROGRAM.—The Sec- retary, acting through the Administrator of the Health
p.000289: Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of
p.000289: this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent
p.000289: years, carry out such program on a national basis.
p.000289: (2) DEFINITION.—For purposes of paragraph (1), the term ‘‘Healthy Start Initiative’’ is a reference to
p.000289: the program that, as an initiative to reduce the rate of infant mortality and im- prove perinatal
p.000289: outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the ef-
p.000289: fective date of this section, was a demonstration program car- ried out under section 301.
p.000289: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000289: (1) REQUIREMENTS.—In making grants under subsection (a), the Secretary shall require that applicants (in
p.000289: addition to meeting all eligibility criteria established by the Secretary) es- tablish, for project areas under
p.000289: such subsection, community- based consortia of individuals and organizations (including agencies
p.000289: responsible for administering block grant programs under title V of the Social Security Act, consumers of
p.000289: project services, public health departments, hospitals, health centers under section 330, and other significant
p.000289: sources of health care services) that are appropriate for participation in projects under subsection (a).
p.000289: (2) OTHER CONSIDERATIONS.—In making grants under sub- section (a), the Secretary shall take into consideration
p.000289: the fol- lowing:
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p.000289: (A) Factors that contribute to infant mortality, such as low birthweight.
p.000289: (B) The extent to which applicants for such grants fa- cilitate—
p.000289: (i) a community-based approach to the delivery of services; and
p.000289: (ii) a comprehensive approach to women’s health care to improve perinatal outcomes.
p.000289: (3) SPECIAL PROJECTS.—Nothing in paragraph (2) shall be construed to prevent the Secretary from
p.000289: awarding grants under subsection (a) for special projects that are intended to address significant
p.000289: disparities in perinatal health indicators in communities along the United States-Mexico border or in Alas- ka or
p.000289: Hawaii.
p.000289: (c) COORDINATION.—Recipients of grants under subsection (a) shall coordinate their services and activities with
p.000289: the State agency
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: compliance satisfac- tory to the Secretary; and
p.000487: (3) otherwise be in such form, be made in such manner, and contain such information and agreements as the
p.000487: Secretary determines to be necessary to carry out this subpart.
p.000487: (c) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary shall—
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p.000487: (1) provide for an evaluation of the activities for which an award is made under sections 398 or 398A; and
p.000487: (2) not later than 1 year after the completion of such eval- uations, submit to the Congress a report describing
p.000487: the find- ings made as a result of the evaluations.
p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000487: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
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p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
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p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
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p.000489: (4) FAMILY SERVICE PLAN.—A case manager, in consulta- tion with a team established in accordance with paragraph
p.000489: (5) for the family involved, shall develop a plan for the family fol- lowing the initial visit to the home of
p.000489: the family. Such plan shall reflect—
p.000489: (A) an assessment of the health and related social service needs of the family;
p.000489: (B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
p.000489: (C) the frequency with which such services are to be provided to the family;
p.000489: (D) ongoing revisions made as the needs of family members change; and
p.000489: (E) the continuing voluntary participation of the fam- ily in the plan.
p.000489: (5) HOME VISITING SERVICES TEAM.—The team to be con- sulted under paragraph (4) on behalf of a family shall
p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
p.000491: the entity will provide continuing training and sufficient support to the home visitors; and
p.000491: (3) such other information as the Secretary determines to be appropriate.
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p.000491: agree that the grant will not be expended—
p.000491: (1) to provide inpatient hospital services;
p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
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p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
p.000527: INFANTS, AND YOUNG CHILDREN.
p.000527: (a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND
p.000527: SYS-
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: PUBLIC HEALTH SERVICE ACT
p.000529: Sec. 399M
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p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
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p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
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p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
p.000529: child hearing screening, evaluation (including audiologic, medical, and language acquisition
p.000529: evalua- tions), diagnosis, and intervention services;
p.000529: (ii) to conduct applied research related to new- born, infant, and young child hearing screening, eval-
p.000529: uation, and intervention programs and outcomes;
p.000529: (iii) to ensure quality monitoring of hearing screening, evaluation, and intervention programs and
p.000529: systems for newborns, infants, and young children; and
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p.000529: (iv) to support newborn, infant, and young child hearing screening, evaluation, and intervention pro-
p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
p.000529: screening, evaluation, and intervention programs and systems;
p.000529: (iii) to collect data and report on newborn, infant, and young child hearing screening, evaluation, diag- nosis,
p.000529: and intervention programs and systems for ap- plied research, program evaluation, and policy im-
p.000529: provement;
p.000529: (iv) to identify the causes and risk factors for con- genital hearing loss;
p.000529: (v) to study the effectiveness of newborn, infant, and young child hearing screening, audiologic and
p.000529: medical evaluations and intervention programs and systems by assessing the health, intellectual and so-
p.000529: cial developmental, cognitive, and hearing status of these children at school age; and
p.000529: (vi) to promote the integration and interoper- ability of data regarding early hearing loss across mul-
p.000529: tiple sources to increase the flow of information be- tween clinical care and public health settings,
p.000529: includ- ing the ability of States and territories to exchange and share data.
p.000529: (2) NATIONAL INSTITUTES OF HEALTH.—The Director of the National Institutes of Health, acting through the
p.000529: Director of the National Institute on Deafness and Other Communication Disorders, shall for purposes of
p.000529: this section, continue a pro- gram of research and development on the efficacy of new screening techniques
p.000529: and technology, including clinical studies of screening methods, studies on efficacy of intervention, and
p.000529: related research.
p.000529: (c) COORDINATION AND COLLABORATION.—
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
p.000531:
p.000531:
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p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000531:
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
...

p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000531:
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p.000531: January 30, 2020
p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
p.000531: of this subsection), by striking ‘‘(3)’’ and all that follows through ‘‘decision making’’ and inserting
p.000531: ‘‘The term ‘medical evaluation’ means key components performed by a physician including history,
p.000531: examination, and medical decisionmaking’’’. Based on the structure of this provision of defined terms, the
p.000531: paragraph (3) enumerator was likely mistakenly left out of the inserted matter. It was re-inserted to reflect
p.000531: the probable intent of Congress.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: PUBLIC HEALTH SERVICE ACT
p.000533: Sec. 399N
p.000533:
p.000533: (1) STATEWIDE NEWBORN AND INFANT HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND SYSTEMS.—For
p.000533: the purpose of carrying out subsection (a), there are authorized to be appropriated to the Health Resources and
p.000533: Services Ad- ministration $17,818,000 for fiscal year 2018, $18,173,800 for fiscal year 2019, $18,628,145
p.000533: for fiscal year 2020, $19,056,592 for fiscal year 2021, and $19,522,758 for fiscal year 2022.
p.000533: (2) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND AP- PLIED RESEARCH; CENTERS FOR DISEASE CONTROL AND
p.000533: PREVEN- TION.—For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated
p.000533: to the Centers for Disease Control and Prevention $10,800,000 for fiscal year 2018,
p.000533: $11,026,800 for fiscal year 2019, $11,302,470 for fiscal year 2020, $11,562,427 for fiscal year 2021, and
p.000533: $11,851,488 for fis- cal year 2022.
p.000533: (3) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND AP- PLIED RESEARCH; NATIONAL INSTITUTE ON DEAFNESS AND
p.000533: OTHER COMMUNICATION DISORDERS.—For the purpose of carrying out subsection (b)(2), there are authorized to be
p.000533: appropriated to the National Institute on Deafness and Other Communication Dis- orders such sums as may be
p.000533: necessary for fiscal years 2011 through 2015.
p.000533: SEC. 399N. ø280g–2¿ CHILDHOOD MALIGNANCIES.
p.000533: (a) IN GENERAL.—The Secretary, acting as appropriate through the Director of the Centers for Disease Control and
p.000533: Prevention and the Director of the National Institutes of Health, shall study envi- ronmental and other risk
p.000533: factors for childhood cancers (including skeletal malignancies, leukemias, malignant tumors of the central
...

p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: PUBLIC HEALTH SERVICE ACT
p.000545: Sec. 399R
p.000545:
p.000545:
p.000545:
p.000545: ery;
p.000545: (A) the core risk factors for preterm labor and deliv-
p.000545: (B) evidence-based strategies to prevent preterm birth
p.000545: and associated outcomes;
p.000545: (C) medically indicated deliveries before full term, and the risks of non-medically indicated deliveries before
p.000545: full term;
p.000545: (D) the importance of preconception and prenatal care, including—
p.000545: (i) smoking cessation;
p.000545: (ii) weight maintenance and good nutrition, in- cluding folic acid intake;
p.000545: (iii) the screening for and the treatment of infec- tions;
p.000545: (iv) screening for and treatment of substance use disorders;
p.000545: (v) screening for and treatment of maternal de- pression;
p.000545: (vi) maternal immunization; and
p.000545: (vii) stress management;
p.000545: (E) treatments and outcomes for premature infants, including late preterm infants; and
p.000545: (F) the informational needs of families during the stay of an infant in a neonatal intensive care unit.
p.000545: (2) programs to increase the availability, awareness, and use of pregnancy and post-term information
p.000545: services that pro- vide evidence-based, clinical information through counselors, community outreach efforts,
p.000545: electronic or telephonic commu- nication, or other appropriate means regarding causes associ- ated with
p.000545: prematurity, birth defects, or health risks to a post- term infant, as well as prevention of a future preterm birth;
p.000545: (3) programs to respond to the informational needs of fami- lies during the stay of an infant in a neonatal
p.000545: intensive care unit, during the transition of the infant to the home, and in the event of a newborn death;
p.000545: and
p.000545: (4) such other programs as the Secretary determines ap- propriate to achieve the purpose specified in
p.000545: subsection (a).
p.000545: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000545: $1,900,000 for each of fiscal years 2014 through 2018.
p.000545: SEC. 399R. ø280g–6¿ CHRONIC KIDNEY DISEASE INITIATIVES.
p.000545: (a) IN GENERAL.—The Secretary shall establish pilot projects
p.000545:
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p.000545: January 30, 2020
p.000545: to—
p.000545:
p.000545: (1) increase public and medical community awareness (particularly of those who treat patients with diabetes
p.000545: and hy- pertension) regarding chronic kidney disease, focusing on pre- vention;
p.000545: (2) increase screening for chronic kidney disease, focusing on Medicare beneficiaries at risk of chronic kidney
p.000545: disease; and
p.000545: (3) enhance surveillance systems to better assess the prev- alence and incidence of chronic kidney disease.
p.000545: (b) SCOPE AND DURATION.—
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: Sec. 399S PUBLIC HEALTH SERVICE ACT 546
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p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
p.000555: organizations in order to increase access to quality healthcare services and to eliminate duplicative care; or
p.000555: (5) to educate, guide, and provide home visitation services regarding maternal health and prenatal care.
p.000555: (c) APPLICATION.—Each eligible entity that desires to receive a grant under subsection (a) shall submit an
p.000555: application to the Sec- retary, at such time, in such manner, and accompanied by such in- formation as the Secretary
p.000555: may require.
p.000555: (d) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to applicants that—
p.000555: (1) propose to target geographic areas—
p.000555: (A) with a high percentage of residents who are eligi- ble for health insurance but are uninsured
p.000555: or under- insured;
p.000555: (B) with a high percentage of residents who suffer from chronic diseases; or
p.000555: (C) with a high infant mortality rate;
p.000555: (2) have experience in providing health or health-related social services to individuals who are underserved
p.000555: with respect to such services; and
p.000555: (3) have documented community activity and experience with community health workers.
p.000555: (e) COLLABORATION WITH ACADEMIC INSTITUTIONS AND THE ONE-STOP DELIVERY SYSTEM.—The Secretary shall
p.000555: encourage com- munity health worker programs receiving funds under this section to collaborate with academic
p.000555: institutions and one-stop delivery sys- tems under section 121(e) of the Workforce Innovation and Oppor- tunity Act.
p.000555: Nothing in this section shall be construed to require such collaboration.
p.000555: (f) EVIDENCE-BASED INTERVENTIONS.—The Secretary shall en- courage community health worker programs
p.000555: receiving funding under this section to implement a process or an outcome-based pay- ment system that rewards
p.000555: community health workers for con- necting underserved populations with the most appropriate serv- ices at
p.000555: the most appropriate time. Nothing in this section shall be construed to require such a payment.
p.000555: (g) QUALITY ASSURANCE AND COST EFFECTIVENESS.—The Sec- retary shall establish guidelines for assuring the
p.000555: quality of the training and supervision of community health workers under the programs funded under this
p.000555: section and for assuring the cost-effec- tiveness of such programs.
p.000555: (h) MONITORING.—The Secretary shall monitor community health worker programs identified in approved
p.000555: applications under this section and shall determine whether such programs are in compliance with the
p.000555: guidelines established under subsection (g).
...

p.000575: fiscal year for the SBHC if the Secretary determines that applying the matching requirement to the SBHC would
p.000575: result in serious hardship or an inability to carry out the purposes of this sec- tion.
p.000575: (h) SUPPLEMENT, NOT SUPPLANT.—Grant funds provided under this section shall be used to supplement, not
p.000575: supplant, other Fed- eral or State funds.
p.000575: (i) EVALUATION.—The Secretary shall develop and implement a plan for evaluating SBHCs and monitoring quality
p.000575: performance under the awards made under this section.
p.000575: (j) AGE APPROPRIATE SERVICES.—An eligible entity receiving funds under this section shall only provide age
p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000575:
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p.000575: Sec. 399Z–2 PUBLIC HEALTH SERVICE ACT 576
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p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
p.000575: (A) is at risk for, shows early signs of, or has been di- agnosed with a mental illness, including a serious
p.000575: emo- tional disturbance; and
p.000575: (B) may benefit from infant and early childhood inter- vention or treatment programs or specialized preschool or
p.000575: elementary school programs that are evidence-based or that have been scientifically demonstrated to show promise
p.000575: but would benefit from further applied development.
p.000575: (2) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a human services agency or nonprofit institution that—
p.000575: (A) employs licensed mental health professionals who have specialized training and experience in infant
p.000575: and early childhood mental health assessment, diagnosis, and treatment, or is accredited or approved by the
p.000575: appropriate State agency, as applicable, to provide for children from in- fancy to 12 years of age mental health
p.000575: promotion, inter- vention, or treatment services; and
p.000575: (B) provides services or programs described in sub- section (a) that are evidence-based or that have
p.000575: been sci- entifically demonstrated to show promise but would benefit from further applied development.
p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
p.000577:
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p.000637: (including im- pairments of the reproductive and autoimmune systems).
p.000637: (4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and
p.000637: disorders.
p.000637: (d) For purposes of this section, an individual shall be consid- ered to have been exposed to DES in utero
p.000637: if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938)
p.000637: administered to the biological mother of the indi- vidual.
p.000637: OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH
p.000637: SEC. 404A. 6 ø283c¿ (a) There is established within the Office of the Director of NIH an office to be known
p.000637: as the Office of Behav- ioral and Social Sciences Research (in this section referred to as the ‘‘Office’’).
p.000637: The Office shall be headed by a director, who shall be appointed by the Director of NIH.
p.000637: (b)(1) With respect to research on the relationship between human behavior and the development, treatment,
p.000637: and prevention of medical conditions, the Director of the Office shall—
p.000637: (A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
p.000637: (B) identify projects of behavioral and social sciences re- search that should be conducted or supported
p.000637: by the national research institutes, and develop such projects in cooperation with such institutes.
p.000637: (2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent
p.000637: behavior, suicide, and homelessness. Such research does not include neurobiological re- search, or research
p.000637: in which the behavior of an organism is ob- served for the purpose of determining activity at the cellular or
p.000637: mo- lecular level.
p.000637: CHILDREN’S VACCINE INITIATIVE
p.000637: SEC. 404B. ø283d¿
p.000637: The Secretary, in consultation with the Director of the Na- tional Vaccine Program under title XXI and acting
p.000637: through the Di- rectors of the National Institute for Allergy and Infectious Dis- eases, the Eunice Kennedy
p.000637: Shriver National Institute of Child Health and Human Development, the National Institute for Aging, and other
p.000637: public and private programs, shall carry out activities, which shall be consistent with the global Children’s
p.000637: Vaccine Initia- tive, to develop affordable new and improved vaccines to be used in the United States and in
p.000637: the developing world that will increase
p.000637:
p.000637:
p.000637:
p.000637: January 30, 2020
p.000637: 6 Section 404 was struck by section 101(b)(2) of Public Law 106–525 (114 Stat. 2501).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000637:
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p.000639: PUBLIC HEALTH SERVICE ACT
p.000639: Sec. 404C
p.000639:
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p.000729: children’s health and development. Subsection (d) of such section requires periodic reports to the Congress
p.000729: regarding the study. The first report is required to be submitted not later than three years after the date
p.000729: of the enactment of the Public Law, which was enacted October 17, 2000.
p.000729: 32 The probable intent of the Congress is to refer to the ‘‘Eunice Kennedy Shriver National Institute of
p.000729: Child Health and Human Development’’. Section 1(b)(7) of Public Law 110–154 (121 Stat 1827) struck the term
p.000729: ‘‘National Institute of Child Health and Human Development’’ and inserted ‘‘Eunice Kennedy Shriver National
p.000729: Institute of Child Health and Human Development’’ each place such term appeared in the heading of subpart 7 of part C
p.000729: of title IV, but not in the text of section 448.
p.000729: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000729:
p.000729:
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p.000729: Sec. 449 PUBLIC HEALTH SERVICE ACT 730
p.000729:
p.000729: including prenatal development, population research, and special health problems and requirements of mothers and
p.000729: children.
p.000729: SUDDEN INFANT DEATH SYNDROME
p.000729: SEC. 449. ø285g–1¿ The Director of the Institute shall conduct and support research which specifically relates to
p.000729: sudden infant death syndrome.
p.000729: SEC. 450. ø285g–2¿ RESEARCH ON INTELLECTUAL DISABILITIES.
p.000729: The Director of the Institute shall conduct and support re- search and related activities into the causes,
p.000729: prevention, and treat- ment of intellectual disabilities.
p.000729: ASSOCIATE DIRECTOR FOR PREVENTION
p.000729: SEC. 451. ø285g–3¿ There shall be in the Institute an Associate Director for Prevention to coordinate and promote the
p.000729: programs in the Institute concerning the prevention of health problems of moth- ers and children. The Associate
p.000729: Director shall be appointed by the Director of the Institute from individuals who because of their pro- fessional
p.000729: training or experience are experts in public health or pre- ventive medicine.
p.000729:
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p.000729:
p.000729: January 30, 2020
p.000729: NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH
p.000729: SEC. 452. ø285g–4¿ (a) There shall be in the Institute an agen- cy to be known as the National Center for
p.000729: Medical Rehabilitation Research (hereafter in this section referred to as the ‘‘Center’’). The Director of the
p.000729: Institute shall appoint a qualified individual to serve as Director of the Center. The Director of the
p.000729: Center shall report directly to the Director of the Institute.
p.000729: (b) The general purpose of the Center is the conduct, support, and coordination of research and research
...

p.001161: population or community
p.001161: with respect to such materials.
p.001161: (2) In the case of any grant or contract under section 1001, such assurances shall provide for the
p.001161: review and approval of the suitability of such materials, prior to their distribution, by an advi- sory committee
p.001161: established by the grantee or contractor in accord- ance with the Secretary’s regulations. Such a
p.001161: committee shall in- clude individuals broadly representative of the population or com- munity to which the
p.001161: materials are to be made available.
p.001161: VOLUNTARY PARTICIPATION
p.001161: SEC. 1007. ø300a–5¿ The acceptance by any individual of fam- ily planning services or family planning or population
p.001161: growth infor- mation (including educational materials) provided through finan- cial assistance under this title
p.001161: (whether by grant or contract) shall be voluntary and shall not be a prerequisite to eligibility for or re- ceipt of
p.001161: any other service or assistance from, or to participation in, any other program of the entity or individual
p.001161: that provided such service or information.
p.001161: PROHIBITION OF ABORTION
p.001161: SEC. 1008. 2 ø300a–6¿ None of the funds appropriated under this title shall be used in programs where abortion
p.001161: is a method of family planning.
p.001161: TITLE XI—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME
p.001161: PART A—GENETIC DISEASES
p.001161: RESEARCH PROJECT GRANTS AND CONTRACTS
p.001161: SEC. 1102. ø300b–1¿ In carrying out section 301, the Secretary, may make grants to public and nonprofit private
p.001161: entities, and may enter into contracts with public and private entities and individ- uals, for projects for
p.001161: (1) basic or applied research leading to the un- derstanding, diagnosis, treatment, and control of genetic
p.001161: diseases,
p.001161: (2) planning, establishing, demonstrating, and developing special programs for the training of genetic
p.001161: counselors, social and behav-
p.001161:
p.001161:
p.001161:
p.001161: January 30, 2020
p.001161: 2 Section 1009 was repealed by section 601(a)(1)(G) of Public Law 105–362 (112 Stat. 3285).
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001163: 1163
p.001163: PUBLIC HEALTH SERVICE ACT
p.001163: Sec. 1104
p.001163:
p.001163: ioral scientists, and other health professionals, (3) the development of programs to educate practicing
p.001163: physicians, other health profes- sionals and the public regarding the nature of genetic processes, the
p.001163: inheritance patterns of genetic diseases, and the means, meth- ods, and facilities available to diagnose, control,
p.001163: counsel, and treat genetic diseases, and (4) the development of counseling and testing programs and other programs for
...

p.001173: other mem- bers of the public to increase their awareness, knowledge, and understanding of newborn screening;
p.001173: (2) increase awareness, knowledge, and understanding of newborn diseases and screening services for expectant
p.001173: individ- uals and families;
p.001173: (3) maintain current information on quality indicators to measure performance of newborn screening, such as
p.001173: false-posi- tive rates and other quality indicators as determined by the Advisory Committee under section
p.001173: 1111;
p.001173: (4) maintain current information on the number of condi- tions for which screening is conducted in each State;
p.001173: and
p.001173: (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect
p.001173: to condi- tions detected by newborn screening.
p.001173: (b) INTERNET AVAILABILITY.—The Secretary, acting through the Administrator, shall ensure that the clearinghouse
p.001173: described under subsection (a)—
p.001173: (1) is available on the Internet;
p.001173: (2) includes an interactive forum;
p.001173: (3) is updated on a regular basis, but not less than quar- terly; and
p.001173: (4) provides—
p.001173: (A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have
p.001173: dem- onstrated expertise in newborn screening that supply re- search-based information on newborn screening
p.001173: tests cur- rently available throughout the United States;
p.001173: (B) information about newborn conditions and screen- ing services available in each State from
p.001173: laboratories cer- tified under subpart 2 of part F of title III, including infor- mation about supplemental screening
p.001173: that is available but not required, in the State where the infant is born;
p.001173: (C) current research on both treatable and not-yet treatable conditions for which newborn screening tests are
p.001173: available;
p.001173: (D) the availability of Federal funding for newborn and child screening for heritable disorders
p.001173: including grants authorized under the Newborn Screening Saves Lives Reauthorization Act of 2014; and
p.001173: (E) other relevant information as determined appro- priate by the Secretary.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001173:
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p.001175: 1175
p.001175: PUBLIC HEALTH SERVICE ACT
p.001175: Sec. 1114
p.001175:
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p.001175: January 30, 2020
p.001175: (c) NONDUPLICATION.—In carrying out activities under this sec- tion, the Secretary shall ensure that such activities
p.001175: minimize dupli- cation and supplement, not supplant, existing information sharing efforts.
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p.001177: ensure that entities receiving funding through the program will provide assurances, as practicable, that such
p.001177: entities will work in consultation with the appropriate State departments of health, and, as practicable, focus
p.001177: their research on screening technology not currently performed in the States in which the entities are located,
p.001177: and the conditions on the uniform screening panel (or the standard test existing on the uniform screening
p.001177: panel).
p.001177: (c) REPORTS.—The Director is encouraged to include informa- tion about the activities carried out under this
p.001177: section in the bien- nial report required under section 403. If such information is in- cluded, the Director
p.001177: shall make such information available to be in- cluded on the Internet Clearinghouse established under section
p.001177: 1112.
p.001177: (d) NONDUPLICATION.—In carrying out programs under this section, the Secretary shall minimize duplication
p.001177: and supplement, not supplant, existing efforts of the type carried out under this sec- tion.
p.001177: (e) PEER REVIEW.—Nothing in this section shall be construed to interfere with the scientific peer-review
p.001177: process at the National Institutes of Health.
p.001177: SEC. 1117. ø300b–16¿ AUTHORIZATION OF APPROPRIATIONS FOR NEW- BORN SCREENING PROGRAMS AND ACTIVITIES.
p.001177: There are authorized to be appropriated—
p.001177: (1) to carry out sections 1109, 1110, 1111, and 1112,
p.001177: $11,900,000 for each of fiscal years 2015 through 2019; and
p.001177: (2) to carry out section 1113, $8,000,000 for each of fiscal years 2015 through 2019.
p.001177: PART B—SUDDEN INFANT DEATH SYNDROME
p.001177:
p.001177:
p.001177:
p.001177:
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p.001177:
p.001177: January 30, 2020
p.001177:
p.001177: SUDDEN INFANT DEATH SYNDROME RESEARCH AND RESEARCH REPORTS
p.001177: SEC. 1122. ø300c–12¿ From the sums appropriated to the Eu- nice Kennedy Shriver National Institute of
p.001177: Child Health and
p.001177: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001177:
p.001177:
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p.001177: Sec. 1132 PUBLIC HEALTH SERVICE ACT 1178
p.001177:
p.001177: Human Development, the Secretary shall assure that there are ap- plied to research of the type described in
p.001177: subparagraphs (A) and
p.001177: (B) of subsection (b)(1) of this section such amounts each year as will be adequate, given the leads and
p.001177: findings then available from such research, in order to make maximum feasible progress toward identification of
p.001177: infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome.
p.001177: PART C—HEMOPHILIA PROGRAMS
p.001177:
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p.001177: January 30, 2020
p.001177: BLOOD SEPARATION CENTERS
p.001177: SEC. 1132. ø300c–22¿ (a) The Secretary may make grants to and enter into contracts with public and
p.001177: nonprofit private entities for projects to develop and expand, within existing facilities, blood- separation centers
p.001177: to separate and make available for distribution blood components to providers of blood services and
p.001177: manufacturers of blood fractions. For purposes of this section—
p.001177: (1) the term ‘‘blood components’’ means those constituents of whole blood which are used for therapy and
p.001177: which are ob- tained by physical separation processes which result in li- censed products such as red
p.001177: blood cells, platelets, white blood cells, AHF-rich plasma, fresh-frozen plasma, cryoprecipitate, and single
p.001177: unit plasma for infusion; and
p.001177: (2) the term ‘‘blood fractions’’ means those constituents of plasma which are used for therapy and which are
p.001177: obtained by licensed fractionation processes presently used in manufac- turing which result in licensed products
p.001177: such as normal serum albumin, plasma, protein fraction, prothrombin complex, fibrinogen, AHF
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p.001341:
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
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p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
p.001347: geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for
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p.001503: (a) STUDY BY INSTITUTE OF MEDICINE.—
p.001503: (1) IN GENERAL.—The Secretary shall request the Institute of Medicine to enter into an agreement with the
p.001503: Secretary
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001503:
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p.001503: Sec. 2631 PUBLIC HEALTH SERVICE ACT 1504
p.001503: under which such Institute conducts a study to provide the fol- lowing:
p.001503: (A) For the most recent fiscal year for which the infor- mation is available, a determination of the number of new-
p.001503: born infants with HIV born in the United States with re- spect to whom the attending obstetrician for the
p.001503: birth did not know the HIV status of the mother.
p.001503: (B) A determination for each State of any barriers, in- cluding legal barriers, that prevent or discourage an obste-
p.001503: trician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn
p.001503: infants for HIV/AIDS in circumstances in which the obste- trician does not know the HIV status of the mother of the
p.001503: infant.
p.001503: (C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, in-
p.001503: cluding recommendations on removing the barriers identi- fied under subparagraph (B).
p.001503: If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another
p.001503: appropriate public or nonprofit private entity to conduct the study.
p.001503: (2) REPORT.—The Secretary shall ensure that, not later than 18 months after the effective date of this
p.001503: section, the study required in paragraph (1) is completed and a report de- scribing the findings made in the
p.001503: study is submitted to the ap- propriate committees of the Congress, the Secretary, and the chief public health
p.001503: official of each of the States.
p.001503: (b) PROGRESS TOWARD RECOMMENDATIONS.—In fiscal year 2004, the Secretary shall collect information
p.001503: from the States de- scribing the actions taken by the States toward meeting the rec- ommendations
p.001503: specified for the States under subsection (a)(1)(C).
p.001503: (c) SUBMISSION OF REPORTS TO CONGRESS.—The Secretary shall submit to the appropriate committees of the
p.001503: Congress reports describing the information collected under subsection (b).
p.001503:
p.001503: Subpart III—Certain Partner Notification Programs
p.001503:
p.001503:
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p.001503:
p.001503:
p.001503: January 30, 2020
p.001503: SEC. 2631. ø300ff–38¿ GRANTS FOR PARTNER NOTIFICATION PRO- GRAMS.
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Searching for indicator institutionalized:

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p.000863: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000863: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000863: programs to dissemi- nate the findings of the knowledge development and application, training and technical
p.000863: assistance programs, and targeted capacity response programs under this section to the general public and
p.000863: to health professionals. The Secretary shall make every effort to pro- vide linkages between the findings of supported
p.000863: projects and State agencies responsible for carrying out substance use disorder pre- vention and treatment
p.000863: programs.
p.000863: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000863: $211,148,000 for each of fiscal years 2018 through 2022.
p.000863: øSection 517 was repealed by section 9017 of Public Law 114–
p.000863: 255. Section 518 was repealed by section 3202(b) of Public Law 106–310 (114 Stat. 1210). Section 519A
p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
p.000863: (3) The term ‘‘youth’’ means persons under the age of 21.
p.000863: (4) The term ‘‘IOM report’’ means the report released in September 2003 by the National Research Council,
p.000863: Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collec- tive Responsibility’’.
p.000863: (b) SENSE OF CONGRESS.—It is the sense of the Congress that:
p.000863: (1) A multi-faceted effort is needed to more successfully ad- dress the problem of underage drinking in the
p.000863: United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to
p.000863: making progress. This Act recognizes the need for a focused national effort, and addresses particulars of the Federal
p.000863: portion of that effort, as well as Fed- eral support for State activities.
p.000863: (2) The Secretary of Health and Human Services shall con- tinue to conduct research and collect data on the
p.000863: short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ
p.000863: systems.
p.000863: (3) States and communities, including colleges and univer- sities, are encouraged to adopt comprehensive
p.000863: prevention ap- proaches, including—
p.000863: (A) evidence-based screening, programs and curricula;
p.000863: (B) brief intervention strategies;
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000863:
p.000863:
p.000863:
p.000863:
p.000863:
p.000863:
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p.001429: exposed to the etiologic agent for acquired immune deficiency syndrome and any individual whom the infected
p.001429: individual may have exposed to such etiologic agent; and
p.001429: (6) the availability, if any, of the services of public health authorities with respect to locating and
p.001429: counseling any indi- vidual described in paragraph (5).
p.001429: (d) RULE OF CONSTRUCTION WITH RESPECT TO COUNSELING WITHOUT TESTING.—Agreements entered into
p.001429: pursuant to sub- sections (a) through (c) may not be construed to prohibit any grant- ee under section 2431 from
p.001429: expending the grant for the purpose of providing counseling services described in such subsections to an
p.001429: individual who will not undergo testing described in such section as a result of the grantee or the
p.001429: individual determining that such testing of the individual is not appropriate.
p.001429: (e) USE OF FUNDS.—
p.001429: (1) The purpose of this subpart 4 is to provide for coun- seling and testing services to prevent and
p.001429: reduce exposure to, and transmission of, the etiologic agent for acquired immune deficiency syndrome.
p.001429: (2) All individuals receiving counseling pursuant to this subpart 4 are to be counseled about the harmful
p.001429: effects of pro- miscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such
p.001429: activities.
p.001429: (3) None of the fund appropriated to carry out this sub- part 4 may be used to provide counseling
p.001429: that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous
p.001429: drug abuse.
p.001429: (4) Paragraph (3) may not be construed to prohibit a coun- selor who has already performed the counseling of an
p.001429: indi- vidual required by paragraph (2), to provide accurate informa- tion about means to reduce an individual’s risk
p.001429: of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
p.001429: informational materials used are not obscene.
p.001429: SEC. 2433. ø300dd–33¿ FUNDING.
p.001429: For the purpose of grants under section 2431, there are author- ized to be appropriated $100,000,000 for each of
p.001429: the fiscal years 1989 and 1990.
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429: January 30, 2020
p.001429: 4 Probably should be ‘‘part’’. See section 118(b)(1)(B) of Public Law 102–321 (106 Stat. 348).
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001429:
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p.001429:
p.001431: 1431
p.001431: PUBLIC HEALTH SERVICE ACT
p.001431: Sec. 2502
p.001431:
p.001431: TITLE XXV—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001431: SEC. 2500. ø300ee¿ USE OF FUNDS.
p.001431: (a) IN GENERAL.—The purpose of this title is to provide for the establishment of education and information
p.001431: programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune
p.001431: deficiency syndrome.
p.001431: (b) CONTENTS OF PROGRAMS.—All programs of education and information receiving funds under this title shall
p.001431: include informa- tion about the harmful effects of promiscuous sexual activity and intravenous substance
p.001431: abuse, and the benefits of abstaining from such activities.
p.001431: (c) LIMITATION.—None of the funds appropriated to carry out this title may be used to provide education or
p.001431: information designed to promote or encourage, directly, homosexual or heterosexual sex- ual activity or intravenous
p.001431: substance abuse.
p.001431: (d) CONSTRUCTION.—Subsection (c) may not be construed to re- strict the ability of an education program that
p.001431: includes the infor- mation required in subsection (b) to provide accurate information about various means
p.001431: to reduce an individual’s risk of exposure to, or the transmission of, the etiologic agent for acquired immune
p.001431: de- ficiency syndrome, provided that any informational materials used are not obscene.
p.001431: PART A—FORMULA GRANTS TO STATES
p.001431: SEC. 2501. ø300ee–11¿ ESTABLISHMENT OF PROGRAM.
p.001431: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001431: fiscal years 1989 through 1991 make an allotment for each State in an amount de- termined in accordance
p.001431: with section 2507. The Secretary shall make payments each such fiscal year to each State from the allot- ment for
p.001431: the State if the Secretary approves for the fiscal year in- volved an application submitted by the State
p.001431: pursuant to section 2503.
p.001431: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001431: unless the State in- volved agrees to expend the payments only for the purpose of car- rying out, in
p.001431: accordance with section 2502, public information ac- tivities with respect to acquired immune deficiency
p.001431: syndrome.
p.001431: SEC. 2502. ø300ee–12¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
...

p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
p.001517:
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p.001517:
p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
p.001517:
p.001517:
p.001517:
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p.001517:
p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
...

p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (2) EMERGENCY PERIOD.—The term ‘‘emergency period’’ means the period in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (c) UNOBLIGATED FUNDS.—If funds under a grant under this section are not expended for an emergency in
p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
p.001521: include a history of program activities within each relevant agency and a description of activi- ties
p.001521: conducted, people served and types of grantees funded, and shall collect and describe best practices in
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p.000257: January 30, 2020
p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000257:
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p.000257:
p.000259: 259
p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
p.000259: (B) recuperative care services;
p.000259: (C) environmental health services, including—
p.000259: (i) the detection and alleviation of unhealthful conditions associated with—
p.000259: (I) water supply;
p.000259: (II) chemical and pesticide exposures;
p.000259: (III) air quality; or
p.000259: (IV) exposure to lead;
p.000259: (ii) sewage treatment;
p.000259: (iii) solid waste disposal;
p.000259: (iv) rodent and parasitic infestation;
p.000259: (v) field sanitation;
p.000259: (vi) housing; and
p.000259: (vii) other environmental factors related to health;
p.000259:
p.000259:
p.000259:
p.000259:
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p.000259:
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p.000267: residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term
p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
p.000267: (2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under this subsection shall be expended to supplement, and not
p.000267: sup- plant, the expenditures of the health center and the value of in kind contributions for the
p.000267: delivery of services to the popu- lation described in paragraph (1).
p.000267: (3) CONSULTATION WITH RESIDENTS.—The Secretary may not make a grant under paragraph (1) unless, with
p.000267: respect to the residents of the public housing involved, the applicant for the grant—
p.000267: (A) has consulted with the residents in the prepara- tion of the application for the grant; and
p.000267: (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the
p.000267: program carried out with the grant.
p.000267: (j) ACCESS GRANTS.—
p.000267: (1) IN GENERAL.—The Secretary may award grants to eligi- ble health centers with a substantial number of
p.000267: clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services
p.000267: for such clients with lim- ited English speaking proficiency.
p.000267: (2) ELIGIBLE HEALTH CENTER.—In this subsection, the term ‘‘eligible health center’’ means an entity that—
p.000267: (A) is a health center as defined under subsection (a);
p.000267: (B) provides health care services for clients for whom English is a second language; and
p.000267: (C) has exceptional needs with respect to linguistic ac- cess or faces exceptional challenges with respect to
p.000267: lin- guistic access.
p.000267: (3) GRANT AMOUNT.—The amount of a grant awarded to a center under this subsection shall be determined by the
p.000267: Ad- ministrator. Such determination of such amount shall be based on the number of clients for whom English is
p.000267: a second lan- guage that is served by such center, and larger grant amounts shall be awarded to centers serving
p.000267: larger numbers of such cli- ents.
p.000267:
p.000267:
p.000267:
p.000267:
p.000267: January 30, 2020
p.000267: 31 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amend- ment to
p.000267: strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such, the amendment has not been
p.000267: carried out above.
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000267:
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p.000267: Sec. 330 PUBLIC HEALTH SERVICE ACT 268
p.000267:
p.000267: (4) USE OF FUNDS.—An eligible health center that receives a grant under this subsection may use funds received
p.000267: through such grant to—
p.000267: (A) provide translation, interpretation, and other such services for clients for whom English is a second language,
p.000267: including hiring professional translation and interpreta- tion services; and
p.000267: (B) compensate bilingual or multilingual staff for lan- guage assistance services provided by the staff for such
p.000267: cli- ents.
p.000267: (5) APPLICATION.—An eligible health center desiring a grant under this subsection shall submit an
p.000267: application to the Secretary at such time, in such manner, and containing such information as the Secretary
p.000267: may reasonably require, includ- ing—
p.000267:
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p.000267:
p.000267: January 30, 2020
p.000267: (A) an estimate of the number of clients that the cen- ter serves for whom English is a second language;
p.000267: (B) the ratio of the number of clients for whom English is a second language to the total number of
p.000267: clients served by the center;
p.000267: (C) a description of any language assistance services that the center proposes to provide to aid clients for
p.000267: whom English is a second language; and
p.000267: (D) a description of the exceptional needs of such cen- ter with respect to linguistic access or a description of the
p.000267: exceptional challenges faced by such center with respect to linguistic access.
p.000267: (6) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, in
p.000267: addition to any funds authorized to be appropriated or appropriated for health centers under any other subsection of
p.000267: this section, such sums as may be necessary for each of fiscal years 2002 through 2006.
p.000267: (k) APPLICATIONS.—
p.000267: (1) SUBMISSION.—No grant may be made under this sec- tion unless an application therefore is submitted
p.000267: to, and ap- proved by, the Secretary. Such an application shall be sub- mitted in such form and manner and
p.000267: shall contain such infor- mation as the Secretary shall prescribe.
p.000267: (2) DESCRIPTION OF UNMET NEED.—An application for a grant under subparagraph (A) or (B) of subsection (e)(1)
p.000267: or sub- section (e)(6) for a health center shall include—
p.000267: (A) a description of the unmet need for health services in the catchment area of the center;
p.000267: (B) a demonstration by the applicant that the area or the population group to be served by the applicant has
p.000267: a shortage of personal health services;
p.000267: (C) a demonstration that the center will be located so that it will provide services to the greatest number of
...

p.000271: (J) the center will review periodically its catchment area to—
p.000271: (i) ensure that the size of such area is such that the services to be provided through the center (includ-
p.000271: ing any satellite) are available and accessible to the residents of the area promptly and as appropriate;
p.000271: (ii) ensure that the boundaries of such area con- form, to the extent practicable, to relevant boundaries of
p.000271: political subdivisions, school districts, and Federal and State health and social service programs; and
p.000271: (iii) ensure that the boundaries of such area elimi- nate, to the extent possible, barriers to access to the
p.000271: services of the center, including barriers resulting from the area’s physical characteristics, its
p.000271: residential patterns, its economic and social grouping, and avail- able transportation;
p.000271: (K) in the case of a center which serves a population including a substantial proportion of individuals of
p.000271: limited English-speaking ability, the center has—
p.000271: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000271:
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p.000271: Sec. 330 PUBLIC HEALTH SERVICE ACT 272
p.000271: (i) developed a plan and made arrangements re- sponsive to the needs of such population for providing services
p.000271: to the extent practicable in the language and cultural context most appropriate to such individuals; and
p.000271:
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p.000271: (ii) identified an individual on its staff who is flu- ent in both that language and in English and whose
p.000271: responsibilities shall include providing guidance to such individuals and to appropriate staff members
p.000271: with respect to cultural sensitivities and bridging lin- guistic and cultural differences;
p.000271: (L) the center, has developed an ongoing referral rela- tionship with one or more hospitals;
p.000271: (M) the center encourages persons receiving or seeking health services from the center to participate in any public or
p.000271: private (including employer-offered) health programs or plans for which the persons are eligible, so long as the cen-
p.000271: ter, in complying with this subparagraph, does not violate the requirements of subparagraph (G)(iii)(I); and
p.000271: (N) the center has written policies and procedures in place to ensure the appropriate use of Federal
p.000271: funds in compliance with applicable Federal statutes, regulations, and the terms and conditions of the Federal
p.000271: award.
p.000271: For purposes of subparagraph (H), the term ‘‘public center’’ means a health center funded (or to be
p.000271: funded) through a grant under this section to a public agency.
p.000271: (l) TECHNICAL ASSISTANCE.—The Secretary shall establish a program through which the Secretary shall provide
p.000271: (either through the Department of Health and Human Services or by grant or con- tract) technical and other
p.000271: assistance to eligible entities to assist such entities to meet the requirements of subsection (k)(3). Services
p.000271: provided through the program may include necessary technical and nonfinancial assistance, including fiscal and program
p.000271: management assistance, training in fiscal and program management, operational and administrative support, and the
...

p.000287: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.000287: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
p.000287: out this section.
p.000287: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000287: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000287: SEC. 330G. ø254c–7¿ SPECIAL NEEDS ADOPTION PROGRAMS; PUBLIC AWARENESS CAMPAIGN AND OTHER ACTIVITIES.
p.000287: (a) SPECIAL NEEDS ADOPTION AWARENESS CAMPAIGN.—
p.000287: (1) IN GENERAL.—The Secretary shall, through making grants to nonprofit private entities, provide for the
p.000287: planning, development, and carrying out of a national campaign to pro- vide information to the public
p.000287: regarding the adoption of chil- dren with special needs.
p.000287: (2) INPUT ON PLANNING AND DEVELOPMENT.—In providing for the planning and development of the national
p.000287: campaign under paragraph (1), the Secretary shall provide for input from a number and variety of adoption organizations
p.000287: throughout the States in order that the full national diversity of interests among adoption organizations
p.000287: is represented in the planning and development of the campaign.
p.000287: (3) CERTAIN FEATURES.—With respect to the national cam- paign under paragraph (1):
p.000287: (A) The campaign shall be directed at various popu- lations, taking into account as appropriate
p.000287: differences among geographic regions, and shall be carried out in the language and cultural context that
p.000287: is most appropriate to the population involved.
p.000287: (B) The means through which the campaign may be carried out include—
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000287: Sec. 330G PUBLIC HEALTH SERVICE ACT 288
p.000287:
p.000287: (i) placing public service announcements on tele- vision, radio, and billboards; and
p.000287: (ii) providing information through means that the Secretary determines will reach individuals who are most likely
p.000287: to adopt children with special needs.
p.000287: (C) The campaign shall provide information on the subsidies and supports that are available to individuals re-
p.000287: garding the adoption of children with special needs.
p.000287: (D) The Secretary may provide that the placement of public service announcements, and the dissemination
p.000287: of brochures and other materials, is subject to review by the Secretary.
p.000287: (4) MATCHING REQUIREMENT.—
p.000287: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out by an entity pursuant
p.000287: to para- graph (1), a condition for the receipt of a grant under such paragraph is that the entity agree to
p.000287: make available (di- rectly or through donations from public or private entities) non-Federal contributions toward
...

p.000367: of such Public Law).
p.000367: 52 Enacted October 27, 1992.
p.000367: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: 369
p.000369: PUBLIC HEALTH SERVICE ACT
p.000369: Sec. 340D
p.000369:
p.000369: into such agreements), may modify such agreements, may extend such agreements, and may terminate such
p.000369: agreements.
p.000369: (d) RULE OF CONSTRUCTION.—This section may not be con- strued as requiring any State to reduce or terminate the
p.000369: supply of vaccines provided by the State to any of the entities described in subsection (a)(2).
p.000369: BREAST AND CERVICAL CANCER INFORMATION
p.000369: SEC. 340D. ø256d¿ (a) IN GENERAL.—As a condition of receiv- ing grants, cooperative agreements, or
p.000369: contracts under this Act, each of the entities specified in subsection (c) shall, to the extent
p.000369: determined to be appropriate by the Secretary, make available in- formation concerning breast and cervical
p.000369: cancer.
p.000369: (b) CERTAIN AUTHORITIES.—In carrying out subsection (a), an entity specified in subsection (c)—
p.000369: (1) may make the information involved available to such individuals as the entity determines appropriate;
p.000369: (2) may, as appropriate, provide information under sub- section (a) on the need for self-examination of the
p.000369: breasts and on the skills for such self-examinations;
p.000369: (3) shall provide information under subsection (a) in the language and cultural context most appropriate to the
p.000369: individ- uals to whom the information is provided; and
p.000369: (4) shall refer such clients as the entities determine appro- priate for breast and cervical cancer screening,
p.000369: treatment, or other appropriate services.
p.000369: (c) RELEVANT ENTITIES.—The entities specified in this sub- section are the following:
p.000369: (1) Entities receiving assistance under section 317F (relat- ing to tuberculosis) 53.
p.000369: (2) Entities receiving assistance under section 318 (relat- ing to sexually transmitted diseases).
p.000369: (3) Migrant health centers receiving assistance under sec- tion 329 54.
p.000369: (4) Community health centers receiving assistance under section 330 54.
p.000369: (5) Entities receiving assistance under section 330(h) (re- lating to homeless individuals).
p.000369: (6) Entities receiving assistance under section 340A 54 (re- lating to health services for residents of public
p.000369: housing).
p.000369: (7) Entities providing services with assistance under title V or title XIX.
p.000369: (8) Entities receiving assistance under section 1001 (relat- ing to family planning).
p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
p.000369:
p.000369:
p.000369:
p.000369: January 30, 2020
...

p.000461: (A)(iv), not later than 1 year after the date of enactment of the Stem Cell Therapeutic and Research
p.000461: Reauthoriza- tion Act of 2010 and annually thereafter, the Secretary shall set an annual goal of
p.000461: increasing collections of high quality cord blood units, øincluding remote collection,¿ 86 consistent with the
p.000461: inventory goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (re- ferred to in
p.000461: this subparagraph as the ‘‘inventory goal’’), and shall identify at least one project under subparagraph (A)(iv)
p.000461: to replicate and expand nationwide, as appropriate. If the Secretary cannot identify a project as described in
p.000461: the preceding sentence, the Secretary shall submit a plan, not later than 180 days after the date on which
p.000461: the Sec- retary was required to identify such a project, to the Com- mittee on Health, Education, Labor, and
p.000461: Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives for
p.000461: expanding collection of high quality cord blood units, øincluding remote collec- tion,¿ 86 consistent with
p.000461: the requirements under the Na- tional Cord Blood Inventory program under section 2 of the Stem Cell
p.000461: Therapeutic and Research Act of 2005 and
p.000461:
p.000461:
p.000461:
p.000461:
p.000461: January 30, 2020
p.000461: 86 Section 2(a)(2) of Public Law 114-104 amends subparagraph (B) by inserting ‘‘ including re- mote collection,’’ after
p.000461: ‘‘cord blood units,’’. Such amendment did not specify to which occurrence of the phrase ‘‘cord blood units,’’ to insert
p.000461: the new language.
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000461:
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p.000463: 463
p.000463: PUBLIC HEALTH SERVICE ACT
p.000463: Sec. 379
p.000463:
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p.000463: January 30, 2020
p.000463: the inventory goal. Each such plan shall be made available to the public.
p.000463: (C) DEFINITION.—In this paragraph, the term ‘‘remote collection’’ means the collection of cord blood units at
p.000463: loca- tions that do not have written contracts with cord blood banks for collection support.
p.000463: (3) SINGLE POINT OF ACCESS; STANDARD DATA.—
p.000463: (A) SINGLE POINT OF ACCESS.—The Secretary shall en- sure that health care professionals and patients are able
...

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p.000529: January 30, 2020
p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
p.000529: (including medical homes for children), and in programs mandated by part C of the Individuals with Disabilities
p.000529: Education Act, which offer programs specifically designed to meet the unique language and communication
p.000529: needs of deaf and hard-of-hearing children.
p.000529: (B) Information provided to families should be accu- rate, comprehensive, up-to-date, and evidence-based,
p.000529: as appropriate, to allow families to make important decisions for their children in a timely manner, including
p.000529: decisions with respect to the full range of assistive hearing tech- nologies and communications modalities, as
p.000529: appropriate.
p.000529: (C) Programs and systems under this paragraph shall offer mechanisms that foster family-to-family and deaf and
p.000529: hard-of-hearing consumer-to-family supports.
p.000529: (2) To continue to provide technical support to States, through one or more technical resource centers, to
p.000529: assist in fur- ther developing and enhancing State early hearing detection and intervention programs.
p.000529: (3) To identify or develop efficient models (educational and medical) to ensure that children who are identified
p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000529:
p.000529:
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p.000529:
p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
p.000529:
p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
p.000529: child hearing screening, evaluation (including audiologic, medical, and language acquisition
p.000529: evalua- tions), diagnosis, and intervention services;
p.000529: (ii) to conduct applied research related to new- born, infant, and young child hearing screening, eval-
p.000529: uation, and intervention programs and outcomes;
p.000529: (iii) to ensure quality monitoring of hearing screening, evaluation, and intervention programs and
p.000529: systems for newborns, infants, and young children; and
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p.000529: (iv) to support newborn, infant, and young child hearing screening, evaluation, and intervention pro-
p.000529: grams, and information systems.
p.000529: (B) USE OF AWARDS.—The awards made under sub- paragraph (A) may be used—
p.000529: (i) to provide technical assistance on data collec- tion and management, including to coordinate and de- velop
p.000529: standardized procedures for data management;
p.000529: (ii) to assess and report on the cost and program effectiveness of newborn, infant, and young child hear- ing
...

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p.000531: January 30, 2020
p.000531: (1) IN GENERAL.—In carrying out programs under this sec- tion, the Administrator of the Health Resources and
p.000531: Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the
p.000531: National Institutes of Health shall collaborate and consult with—
p.000531: (A) other Federal agencies;
p.000531: (B) State and local agencies, including agencies re- sponsible for early intervention services pursuant to
p.000531: title XIX of the Social Security Act (Medicaid Early and Peri- odic Screening, Diagnosis and Treatment
p.000531: Program); title XXI of the Social Security Act (State Children’s Health In- surance Program); title V of the
p.000531: Social Security Act (Ma- ternal and Child Health Block Grant Program); and part C of the Individuals with
p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
...

p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000531:
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p.000531: January 30, 2020
p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
...

p.000617: (II) UNAPPROVED PRODUCTS.—The regulations under this subparagraph shall establish whether or not the results
p.000617: information described in clause
p.000617: (iii) shall be required for—
p.000617: (aa) an applicable drug clinical trial for a drug that is not approved under section 505 of the Federal Food, Drug, and
p.000617: Cosmetic Act and not licensed under section 351 of this Act (whether approval or licensure was sought or
p.000617: not); and
p.000617: (bb) an applicable device clinical trial for a device that is not cleared under section
p.000617: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000619: 619
p.000619: PUBLIC HEALTH SERVICE ACT
p.000619: Sec. 402
p.000619:
p.000619: 510(k) of the Federal Food, Drug, and Cos- metic Act and not approved under section 515 or section 520(m) of
p.000619: such Act (whether clear- ance or approval was sought or not).
p.000619: (iii) REQUIRED ELEMENTS.—The regulations under this subparagraph shall require, in addition to the ele- ments
p.000619: described in subparagraph (C), information within each of the following categories:
p.000619: (I) A summary of the clinical trial and its re- sults that is written in non-technical, understand- able
p.000619: language for patients, if the Secretary deter- mines that such types of summary can be included without being
p.000619: misleading or promotional.
p.000619: (II) A summary of the clinical trial and its re- sults that is technical in nature, if the Secretary determines
p.000619: that such types of summary can be in- cluded without being misleading or promotional.
p.000619: (III) The full protocol or such information on the protocol for the trial as may be necessary to help
p.000619: to evaluate the results of the trial.
p.000619: (IV) Such other categories as the Secretary determines appropriate.
p.000619: (iv) RESULTS SUBMISSION.—The results informa- tion described in clause (iii) shall be submitted to the
p.000619: Director of NIH for inclusion in the registry and re- sults data bank as provided by subparagraph (E),
p.000619: ex- cept that the Secretary shall by regulation deter- mine—
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p.000619: (I) whether the 1-year period for submission of clinical trial information described in subpara- graph
p.000619: (E)(i) should be increased from 1 year to a period not to exceed 18 months;
p.000619: (II) whether the clinical trial information de- scribed in clause (iii) should be required to be sub- mitted for
p.000619: an applicable clinical trial for which the clinical trial information described in subpara- graph (C) is
p.000619: submitted to the registry and results data bank before the effective date of the regula- tions issued under
p.000619: this subparagraph; and
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p.000619: (aa) the certification process under sub- paragraph (E)(iii) when approval, licensure, or clearance is sought; and
p.000619: (bb) whether there should be a delay of submission when approval, licensure, or clear- ance will not be sought.
p.000619: (v) ADDITIONAL PROVISIONS.—The regulations under this subparagraph shall also establish—
p.000619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000619: Sec. 402 PUBLIC HEALTH SERVICE ACT 620
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p.000619:
p.000619: January 30, 2020
p.000619:
p.000619: (I) a standard format for the submission of clinical trial information under this paragraph to the
p.000619: registry and results data bank;
p.000619: (II) additional information on clinical trials and results that is written in nontechnical, under- standable
p.000619: language for patients;
p.000619: (III) considering the experience under the pilot quality control project described in para- graph
p.000619: (5)(C), procedures for quality control, in- cluding using representative samples, with respect to completeness
p.000619: and content of clinical trial infor- mation under this subsection, to help ensure that data elements are not
p.000619: false or misleading and are non-promotional;
p.000619: (IV) the appropriate timing and requirements for updates of clinical trial information, and whether and,
p.000619: if so, how such updates should be tracked;
p.000619: (V) a statement to accompany the entry for an applicable clinical trial when the primary and sec- ondary outcome
p.000619: measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the
p.000619: submission of such informa- tion in paragraph (2)(C); and
p.000619: (VI) additions or modifications to the manner of reporting of the data elements established under
p.000619: subparagraph (C).
p.000619: (vi) CONSIDERATION OF WORLD HEALTH ORGANIZA- TION DATA SET.—The Secretary shall consider the sta- tus of the
p.000619: consensus data elements set for reporting clinical trial results of the World Health Organization when issuing
p.000619: the regulations under this subpara- graph.
p.000619: (vii) PUBLIC MEETING.—The Secretary shall hold a public meeting no later than 18 months after the date of the enactment
p.000619: of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties
p.000619: with regard to the regu- lations to be issued under this subparagraph.
p.000619: (E) SUBMISSION OF RESULTS INFORMATION.—
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p.000739: recommend a process through which scientifically validated alternative methods can be accepted for regulatory
p.000739: use;
p.000739: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000739:
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p.000739:
p.000739: Sec. 463B PUBLIC HEALTH SERVICE ACT 740
p.000739:
p.000739: (5) to communicate the results of research to government agencies, to medical, scientific, and regulatory
p.000739: communities, and to the public; and
p.000739: (6) to integrate related activities of the Department of Health and Human Services.
p.000739: METHODS OF CONTROLLING CERTAIN INSECT AND VERMIN POPULATIONS
p.000739: SEC. 463B. ø285l–6¿ The Director of the Institute shall conduct or support research to identify or develop methods of
p.000739: controlling in- sect and vermin populations that transmit to humans diseases that have significant adverse health
p.000739: consequences.
p.000739: Subpart 13—National Institute on Deafness and Other Communication Disorders
p.000739: PURPOSE OF THE INSTITUTE
p.000739: SEC. 464. ø285m¿ The general purpose of the National Insti- tute on Deafness and Other Communication
p.000739: Disorders (hereafter referred to in this subpart as the ‘‘Institute’’) is the conduct and support of
p.000739: research and training, the dissemination of health infor- mation, and other programs with respect to disorders
p.000739: of hearing and other communication processes, including diseases affecting hearing, balance, voice, speech,
p.000739: language, taste, and smell.
p.000739: NATIONAL DEAFNESS AND OTHER COMMUNICATION DISORDERS PROGRAM
p.000739: SEC. 464A. ø285m–1¿ (a) The Director of the Institute, with the advice of the Institute’s advisory council,
p.000739: shall establish a Na- tional Deafness and Other Communication Disorders Program (hereafter in this section
p.000739: referred to as the ‘‘Program’’). The Direc- tor or 37 the Institute shall, with respect to the Program,
p.000739: prepare and transmit to the Director of NIH a plan to initiate, expand, in- tensify and coordinate activities of
p.000739: the Institute respecting dis- orders of hearing (including tinnitus) and other communication processes,
p.000739: including diseases affecting hearing, balance, voice, speech, language, taste, and smell. The plan
p.000739: shall include such comments and recommendations as the Director of the Institute de- termines appropriate. The
p.000739: Director of the Institute shall periodi- cally review and revise the plan and shall transmit any
p.000739: revisions of the plan to the Director of NIH.
p.000739: (b) Activities under the Program shall include—
p.000739: (1) investigation into the etiology, pathology, detection, treatment, and prevention of all forms of
p.000739: disorders of hearing and other communication processes, primarily through the sup- port of basic research in such
p.000739: areas as anatomy, audiology, bio- chemistry, bioengineering, epidemiology, genetics, immunology, microbiology,
p.000739: molecular biology, the neurosciences, otolaryn- gology, psychology, pharmacology, physiology, speech and lan-
p.000739: guage pathology, and any other scientific disciplines that can
p.000739:
p.000739:
p.000739:
p.000739:
p.000739: January 30, 2020
p.000739: 37 So in law. See section 2(4) of Public Law 100–553 (102 Stat. 2769). Probably should be ‘‘Di- rector of’’.
p.000739: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000739:
p.000741: 741
p.000741: PUBLIC HEALTH SERVICE ACT
p.000741: Sec. 464C
p.000741:
p.000741: contribute important knowledge to the understanding and elimination of disorders of hearing and other
p.000741: communication processes;
p.000741: (2) research into the evaluation of techniques (including surgical, medical, and behavioral approaches) and
p.000741: devices (in- cluding hearing aids, implanted auditory and nonauditory prosthetic devices and other
p.000741: communication aids) used in diag- nosis, treatment, rehabilitation, and prevention of disorders of hearing and other
p.000741: communication processes;
p.000741: (3) research into prevention, and early detection and diag- nosis, of hearing loss and speech and language
p.000741: disturbances (including stuttering) and research into preventing the effects of such disorders on learning and
p.000741: learning disabilities with ex- tension of programs for appropriate referral and rehabilitation;
p.000741: (4) research into the detection, treatment, and prevention of disorders of hearing and other communication
p.000741: processes in the growing elderly population with extension of rehabilitative programs to ensure continued effective
p.000741: communication skills in such population;
p.000741: (5) research to expand knowledge of the effects of environ- mental agents that influence hearing or other
p.000741: communication processes; and
p.000741: (6) developing and facilitating intramural programs on clinical and fundamental aspects of disorders of hearing
p.000741: and all other communication processes.
p.000741: DATA SYSTEM AND INFORMATION CLEARINGHOUSE
p.000741: SEC. 464B. ø285m–2¿ (a) The Director of the Institute shall es- tablish a National Deafness and Other
p.000741: Communication Disorders Data System for the collection, storage, analysis, retrieval, and dis- semination of data
p.000741: derived from patient populations with disorders of hearing or other communication processes, including where pos-
p.000741: sible, data involving general populations for the purpose of identi- fying individuals at risk of developing
p.000741: such disorders.
p.000741: (b) The Director of the Institute shall establish a National Deafness and Other Communication Disorders
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p.000743: January 30, 2020
p.000743: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY BOARD
p.000743: SEC. 464D. ø285m–4¿ (a) The Secretary shall establish in the Institute the National Deafness and Other
p.000743: Communications Dis- orders Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000743: (b) The Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000743: follows:
p.000743: (1) The Secretary shall appoint—
p.000743: (A) twelve members from individuals who are sci- entists, physicians, and other health and rehabilitation
p.000743: professionals, who are not officers or employees of the United States, and who represent the specialties
p.000743: and dis- ciplines relevant to deafness and other communication dis- orders, including not less than two persons with a
p.000743: commu- nication disorder; and
p.000743: (B) six members from the general public who are knowledgeable with respect to such disorders, including
p.000743: not less than one person with a communication disorder and not less than one person who is a parent
p.000743: of an indi- vidual with such a disorder.
p.000743: Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in
p.000743: diagnoses and re- habilitation of communication disorders, education of the hear- ing, speech, or language
p.000743: impaired, public health, public infor- mation, community program development, occupational haz- ards to
p.000743: communications senses, or the aging process.
p.000743: (2) The following shall be ex officio members of each Advi- sory Board:
p.000743: (A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness
p.000743: and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the
p.000743: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000743: Health Affairs (or the designees of such officers).
p.000743: (B) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000743: sory Board to carry out its functions.
p.000743: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000743: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000743: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000743: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000743: engaged in the per- formance of their duties as members of the Board.
p.000743: (d) The term of office of an appointed member of the Advisory Board is four years, except that no term of
p.000743: office may extend be- yond the expiration of the Advisory Board. Any member appointed
p.000743: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000743:
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p.000851: January 30, 2020
p.000851:
p.000851: Government, may not be included in determining the amount of such non-Federal contributions.
p.000851: (g) OUTREACH.—A funding agreement for an award under sub- section (a) for an applicant is that the applicant
p.000851: will provide out- reach services in the community involved to identify women who have a substance use
p.000851: disorder and to encourage the women to un- dergo treatment for such disorder.
p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
p.000851: (3) will not be imposed on any such woman with an income of less than 185 percent of the official poverty
p.000851: line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000851: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000851: (k) REPORTS TO DIRECTOR.—A funding agreement for an award under subsection (a) is that the applicant involved
p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
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p.001113: appropriately coordinated with experiments, demonstration projects, and other related activities authorized by
p.001113: the Social Security Act and the So- cial Security Amendments of 1967. Activities under subsection (a)(2) of
p.001113: this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall
p.001113: be carried out con- sistent with section 1142 of such Act.
p.001113: (e) DISCLAIMER.—The Agency shall not mandate national standards of clinical practice or quality health care
p.001113: standards. Rec- ommendations resulting from projects funded and published by the Agency shall include a corresponding
p.001113: disclaimer.
p.001113: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to imply that the Agency’s role is to
p.001113: mandate a national standard or specific approach to quality measurement and report- ing. In research and
p.001113: quality improvement activities, the Agency shall consider a wide range of choices, providers, health care deliv-
p.001113: ery systems, and individual preferences.
p.001113: SEC. 903. ø299a–1¿ RESEARCH ON HEALTH DISPARITIES.
p.001113: (a) IN GENERAL.—The Director shall—
p.001113: (1) conduct and support research to identify populations for which there is a significant disparity in
p.001113: the quality, out- comes, cost, or use of health care services or access to and sat- isfaction with such services,
p.001113: as compared to the general popu- lation;
p.001113: (2) conduct and support research on the causes of and bar- riers to reducing the health disparities identified in
p.001113: paragraph (1), taking into account such factors as socioeconomic status, attitudes toward health, the language
p.001113: spoken, the extent of for- mal education, the area or community in which the population resides, and other factors the
p.001113: Director determines to be appro- priate;
p.001113: (3) conduct and support research and support demonstra- tion projects to identify, test, and evaluate strategies
p.001113: for reduc- ing or eliminating health disparities, including development or identification of effective service delivery
p.001113: models, and dissemi- nate effective strategies and models;
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001113:
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p.001113:
p.001115: 1115
p.001115: PUBLIC HEALTH SERVICE ACT
p.001115: Sec. 903
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p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
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p.001171: (C) diagnostic and other technology used in screening;
p.001171: (D) the availability and reporting of testing for condi- tions for which there is no existing treatment,
p.001171: including information on cost and incidence;
p.001171: (E) conditions not included in the recommended uni- form screening panel that are treatable with Food
p.001171: and Drug Administration-approved products or other safe and effective treatments, as determined by
p.001171: scientific evidence and peer review;
p.001171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001171: Sec. 1111 PUBLIC HEALTH SERVICE ACT 1172
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p.001171: January 30, 2020
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p.001171: (F) minimum standards and related policies and proce- dures used by State newborn screening programs, such as language
p.001171: and terminology used by State newborn screen- ing programs to include standardization of case definitions and
p.001171: names of disorders for which newborn screening tests are performed;
p.001171: (G) quality assurance, oversight, and evaluation of State newborn screening programs, including
p.001171: ensuring that tests and technologies used by each State meet estab- lished standards for detecting and
p.001171: reporting positive screening results;
p.001171: (H) public and provider awareness and education;
p.001171: (I) the cost and effectiveness of newborn screening and medical evaluation systems and intervention programs
p.001171: conducted by State-based programs;
p.001171: (J) identification of the causes of, public health im- pacts of, and risk factors for heritable disorders;
p.001171: (K) coordination of surveillance activities, including standardized data collection and reporting,
p.001171: harmonization of laboratory definitions for heritable disorders and testing results, and confirmatory testing and
p.001171: verification of posi- tive results, in order to assess and enhance monitoring of newborn diseases; and
p.001171: (L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable
p.001171: disorders in newborns in order to ensure rapid diagnosis and fol- lowup.
p.001171: (c) MEMBERSHIP.—
p.001171: (1) IN GENERAL.—The Secretary shall appoint not to exceed
p.001171: 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001171: total member- ship of the Advisory Committee is an odd number.
...

p.001233: Secretary shall notify the entity in writing of the determination. Such notice shall specify the manner in which the
p.001233: entity has not complied with such assur- ances and direct that the entity initiate (within 30 days of the date the
p.001233: notice is issued by the Secretary or within such longer period as the Secretary determines is
p.001233: reasonable) such action as may be necessary to bring (within such period as the Secretary shall pre-
p.001233: scribe) the entity into compliance with the assurances. If the entity fails to initiate corrective action within the
p.001233: period prescribed by the notice or fails to comply with the assurances within such period as the Secretary prescribes,
p.001233: then after the Secretary provides the enti- ty a reasonable opportunity for reconsideration of his determina-
p.001233: tion, including, at the entity’s election, a fair hearing (A) the entity shall not be a qualified health
p.001233: maintenance organization for pur- poses of section 1310 until such date as the Secretary determines that
p.001233: it is in compliance with the assurances, and (B) each employer which has offered membership in the entity in compliance
p.001233: with sec- tion 1310, each lawfully recognized collective bargaining represent- ative or other employee
p.001233: representative which represents the em- ployees of each such employer, and the members of such entity
p.001233: shall be notified by the entity that the entity is not a qualified health maintenance organization for
p.001233: purposes of such section. The notice required by clause (B) of the preceding sentence shall con- tain, in
p.001233: readily understandable language, the reasons for the deter- mination that the entity is not a qualified health
p.001233: maintenance or- ganization. The Secretary shall publish in the Federal Register each determination referred to
p.001233: in this paragraph.
p.001233: (2) If the Secretary makes, with respect to an entity which has received a grant, contract, loan, or loan guarantee
p.001233: under this title, a determination described in subsection (a), the Secretary may, in addition to any other
p.001233: remedies available to him, bring a civil action in the United States district court for the district in which such en-
p.001233: tity is located to enforce its compliance with the assurances it fur- nished respecting the provision of basic
p.001233: and supplemental health
p.001233: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001233:
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p.001233: Sec. 1313 PUBLIC HEALTH SERVICE ACT 1234
p.001233:
p.001233: services or its organization or operation, as the case may be, which assurances were made in connection with its
p.001233: application under this title for the grant, contract, loan, or loan guarantee.
p.001233: LIMITATION ON SOURCE OF FUNDING FOR HEALTH MAINTENANCE ORGANIZATIONS
p.001233: SEC. 1313. ø300e–12¿ No funds appropriated under any provi- sion of this Act (except as provided in sections 329 and
p.001233: 330) other than this title may be used—
p.001233: (1) for grants or contracts for surveys or other activities to determine the feasibility of developing or
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p.001273: agencies, as well as Departmental and Cabinet agencies and organizations, and
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001273: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1274
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p.001273: January 30, 2020
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p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
p.001273: (9) Carry out programs to improve access to health care services for individuals with limited proficiency in
p.001273: speaking the English language. Activities under the preceding sentence shall include developing and evaluating model
p.001273: projects.
p.001273: (10) Advise in matters related to the development, imple- mentation, and evaluation of health professions
p.001273: education in
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: 1275
p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
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p.001275: (C) The nonvoting, ex officio members of the Com- mittee shall be such officials of the Department of
p.001275: Health and Human Services as the Secretary determines to be ap- propriate.
p.001275: (5) TERMS.—Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall
p.001275: initially ap- point a portion of the members to terms of 1 year, 2 years, and 3 years.
p.001275: (6) VACANCIES.—If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary
p.001275: within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which the
p.001275: predecessor of such mem- ber was appointed. The vacancy shall not affect the power of the remaining members
p.001275: to execute the duties of the Com- mittee.
p.001275: (7) COMPENSATION.—Members of the Committee who are officers or employees of the United States shall serve
p.001275: without compensation. Members of the Committee who are not officers or employees of the United States shall
p.001275: receive compensation, for each day (including travel time) they are engaged in the performance of the
p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
p.001275: (1) RECOMMENDATIONS REGARDING LANGUAGE.—
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1276
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p.001275: January 30, 2020
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p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
p.001275: the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other
p.001275: appro- priate departmental entities regarding recommendations for carrying out activities under subsection (b)(9).
p.001275: (B) HEALTH PROFESSIONS EDUCATION REGARDING HEALTH DISPARITIES.—The Deputy Assistant Secretary
p.001275: shall carry out the duties under subsection (b)(10) in col- laboration with appropriate personnel of the
p.001275: Department of Health and Human Services, other Federal agencies, and other offices, centers, and institutions,
p.001275: as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and
p.001275: Education Act of 2000.
p.001275: (2) EQUITABLE ALLOCATION REGARDING ACTIVITIES.—In car- rying out subsection (b), the Secretary shall ensure
p.001275: that serv- ices provided under such subsection are equitably allocated among all groups served under this
p.001275: section by the Secretary.
p.001275: (3) CULTURAL COMPETENCY OF SERVICES.—The Secretary shall ensure that information and services provided
p.001275: pursuant to subsection (b) are provided in the language, educational, and cultural context that is most appropriate for
p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
p.001275: paragraph (1) during the pre- ceding 2 fiscal years. The report shall be included in the report required under
p.001275: subsection (f) for the fiscal year involved.
p.001275: (f) REPORTS.—
p.001275: (1) IN GENERAL.—Not later than February 1 of fiscal year 1999 and of each second year thereafter, the
p.001275: Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the
p.001275: Committee on Labor and Human Resources of the Senate, a report describing the activi- ties carried out under this
p.001275: section during the preceding 2 fiscal years and evaluating the extent to which such activities have been
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p.001455: treatment and care.
p.001455: (B) DEMONSTRATED NEED.—The factors considered by the Secretary in determining whether an eligible area has a
p.001455: demonstrated need for purposes of paragraph (1)(B) may include any or all of the following:
p.001455: (i) The unmet need for such services, as deter- mined under section 2602(b)(4) or other community input
p.001455: process as defined under section 2609(d)(1)(A).
p.001455: (ii) An increasing need for HIV/AIDS-related serv- ices, including relative rates of increase in the number of cases of
p.001455: HIV/AIDS.
p.001455: (iii) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging sub-
p.001455: populations.
p.001455: (iv) The current prevalence of HIV/AIDS.
p.001455: (v) Relevant factors related to the cost and com- plexity of delivering health care to individuals with
p.001455: HIV/AIDS in the eligible area.
p.001455: (vi) The impact of co-morbid factors, including co- occurring conditions, determined relevant by the Sec-
p.001455: retary.
p.001455: (vii) The prevalence of homelessness.
p.001455: (viii) The prevalence of individuals described under section 2602(b)(2)(M).
p.001455: (ix) The relevant factors that limit access to health care, including geographic variation, adequacy
p.001455: of health insurance coverage, and language barriers.
p.001455: (x) The impact of a decline in the amount received pursuant to subsection (a) on services available to all
p.001455: individuals with HIV/AIDS identified and eligible under this title.
p.001455: (C) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this subsection to an eligible area to
p.001455: address the decline or disruption of all EMA-provided serv- ices related to the decline in the amounts received
p.001455: pursu- ant to subsection (a) consistent with the grant award for the eligible area for fiscal year 2006, to
p.001455: the extent that the factor under subparagraph (B)(x) (relating to a decline in funding) applies to the eligible
p.001455: area.
p.001455: (D) INCREASED ADJUSTMENT FOR CERTAIN AREAS PRE- VIOUSLY USING CODE-BASED REPORTING.—For purposes of this
p.001455: subsection for each of fiscal years 2010 through 2012, the Secretary shall deem the applicable number of living
p.001455: cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for Disease Control and
p.001455: Preven- tion to be 3 percent higher than the actual number if the
p.001455: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001455: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1456
p.001455: conditions described in items (aa) through (cc) of sub- section (a)(3)(C)(vi)(III) are all satisfied.
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p.001495: (1) The unmet need for such services, as determined under section 2617(b).
p.001495: (2) An increasing need for HIV/AIDS-related services, in- cluding relative rates of increase in the
p.001495: number of cases of HIV/AIDS.
p.001495: (3) The relative rates of increase in the number of cases of HIV/AIDS within new or emerging subpopulations.
p.001495: (4) The current prevalence of HIV/AIDS.
p.001495: (5) Relevant factors related to the cost and complexity of delivering health care to individuals with HIV/AIDS
p.001495: in the eli- gible area.
p.001495: (6) The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.
p.001495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001497: PUBLIC HEALTH SERVICE ACT
p.001497: Sec. 2621
p.001497:
p.001497: (7) The prevalence of homelessness.
p.001497: (8) The prevalence of individuals described under section 2602(b)(2)(M).
p.001497: (9) The relevant factors that limit access to health care, in- cluding geographic variation, adequacy of health
p.001497: insurance cov- erage, and language barriers.
p.001497: (10) The impact of a decline in the amount received pursu- ant to section 2618 on services available to all individuals
p.001497: with HIV/AIDS identified and eligible under this title.
p.001497: (c) PRIORITY IN MAKING GRANTS.—The Secretary shall provide funds under this section to a State to
p.001497: address the decline in serv- ices related to the decline in the amounts received pursuant to sec- tion 2618
p.001497: consistent with the grant award to the State for fiscal year 2006, to the extent that the factor under
p.001497: subsection (b)(10) (re- lating to a decline in funding) applies to the State.
p.001497: (d) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001497: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001497: shall include information detail- ing—
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p.001497: (1) the total amount of supplemental funds available under
p.001497: this section for the year involved;
p.001497: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of section
p.001497: 2618(a)(2);
p.001497: (3) the amount of supplemental funds disbursed pursuant to subsection (c);
p.001497: (4) the disbursement of the remainder of the supplemental funds after taking into account the uses described in
p.001497: para- graphs (2) and (3); and
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p.001539: (c) REQUIREMENTS FOR UNIFORM TERMINATION OF COVERAGE.—
p.001539: (1) PARTICULAR TYPE OF COVERAGE NOT OFFERED.—In any case in which an issuer decides to discontinue
p.001539: offering a par- ticular type of group or individual health insurance coverage, coverage of such type may be
p.001539: discontinued by the issuer in ac- cordance with applicable State law in such market only if—
p.001539: (A) the issuer provides notice to each plan sponsor or individual, as applicable, provided coverage of this
p.001539: type in such market (and participants and beneficiaries covered under such coverage) of such discontinuation
p.001539: at least 90 days prior to the date of the discontinuation of such cov- erage;
p.001539: (B) the issuer offers to each plan sponsor or individual, as applicable, provided coverage of this type in such
p.001539: mar- ket, the option to purchase all (or, in the case of the large group market, any) other health insurance
p.001539: coverage cur- rently being offered by the issuer to a group health plan or individual health insurance
p.001539: coverage 2 in such market; and
p.001539: (C) in exercising the option to discontinue coverage of this type and in offering the option of coverage under
p.001539: sub-
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p.001539: January 30, 2020
p.001539: 2 Section 1563(c)(9)(C)(i)(III)(bb) (relating to conforming amendments--originally designated as section 1562 and
p.001539: redesignated as section 1563 by section 10107(b)(1)) of Public Law 111–148 provides for an amendment to
p.001539: insert ‘‘or individual health insurance coverage’’. Such amend- ment did not specify where to insert this new
p.001539: language, however, it was carried out by inserting such language after ‘‘group health plan’’ to reflect the probable
p.001539: intent of Congress.
p.001539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001541: paragraph (B), the issuer acts uniformly without regard to the claims experience of those sponsors or
p.001541: individuals, as applicable, or any health status-related factor relating to any participants or
p.001541: beneficiaries covered or new partici- pants or beneficiaries who may become eligible for such coverage.
p.001541: (2) DISCONTINUANCE OF ALL COVERAGE.—
p.001541: (A) IN GENERAL.—In any case in which a health insur- ance issuer elects to discontinue offering all health
p.001541: insur- ance coverage in the individual or group market, or all markets, in a State, health insurance coverage
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p.001561: insurance-related consumer advocacy organizations, health insurance issuers, health care professionals,
p.001561: patient advocates in- cluding those representing individuals with limited English pro- ficiency, and other
p.001561: qualified individuals.
p.001561: (b) REQUIREMENTS.—The standards for the summary of bene- fits and coverage developed under subsection (a)
p.001561: shall provide for the following:
p.001561: (1) APPEARANCE.—The standards shall ensure that the summary of benefits and coverage is presented in a
p.001561: uniform format that does not exceed 4 pages in length and does not in- clude print smaller than 12-point font.
p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001563: PUBLIC HEALTH SERVICE ACT
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p.001563: January 30, 2020
p.001563: (2) LANGUAGE.—The standards shall ensure that the sum- mary is presented in a culturally and linguistically appropriate
p.001563: manner and utilizes terminology understandable by the aver- age plan enrollee.
p.001563: (3) CONTENTS.—The standards shall ensure that the sum- mary of benefits and coverage includes—
p.001563: (A) uniform definitions of standard insurance terms and medical terms (consistent with subsection (g)) so
p.001563: that consumers may compare health insurance coverage and understand the terms of coverage (or exception to
p.001563: such coverage);
p.001563: (B) a description of the coverage, including cost shar- ing for—
p.001563: (i) each of the categories of the essential health benefits described in subparagraphs (A) through (J) of
p.001563: section 1302(b)(1) of the Patient Protection and Afford- able Care Act; and
p.001563: (ii) other benefits, as identified by the Secretary;
p.001563: (C) the exceptions, reductions, and limitations on cov- erage;
p.001563: (D) the cost-sharing provisions, including deductible, coinsurance, and co-payment obligations;
p.001563: (E) the renewability and continuation of coverage pro- visions;
p.001563: (F) a coverage facts label that includes examples to il- lustrate common benefits scenarios, including pregnancy
p.001563: and serious or chronic medical conditions and related cost sharing, such scenarios to be based on recognized
p.001563: clinical practice guidelines;
p.001563: (G) a statement of whether the plan or coverage—
p.001563: (i) provides minimum essential coverage (as de- fined under section 5000A(f) of the Internal Revenue Code
p.001563: 1986); and
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p.001585:
p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
p.001585:
p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
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p.001589: relation to any partner.
p.001589: (3) PARTICIPANTS OF GROUP HEALTH PLANS.—In the case of a group health plan, the term ‘‘participant’’ also includes—
p.001589: (A) in connection with a group health plan maintained by a partnership, an individual who is a partner in
p.001589: rela- tion to the partnership, or
p.001589: (B) in connection with a group health plan maintained by a self-employed individual (under which one or more
p.001589: employees are participants), the self-employed individual,
p.001589: if such individual is, or may become, eligible to receive a ben- efit under the plan or such individual’s
p.001589: beneficiaries may be el- igible to receive any such benefit.
p.001589: SEC. 2723. ø300gg–22¿ ENFORCEMENT.
p.001589: (a) STATE ENFORCEMENT.—
p.001589: (1) STATE AUTHORITY.—Subject to section 2723, each State may require that health insurance issuers that issue,
p.001589: sell, renew, or offer health insurance coverage in the State in the individual or group market meet the
p.001589: requirements of this part with respect to such issuers.
p.001589:
p.001589:
p.001589:
p.001589:
p.001589:
p.001589:
p.001589: January 30, 2020
p.001589: 18 Section 1563 (relating to conforming amendments--originally designated as section 1562 and redesignated as section
p.001589: 1563 by section 10107(b)(1)) of Public Law 111–148 provides for an amendment to insert ‘‘or, with
p.001589: respect to individual coverage, under any health insurance cov- erage maintained by the same health insurance
p.001589: issuer’’. Such amendment did not specify where to insert this new language, however, it was carried out by inserting
p.001589: this new language before the period at the end in order to reflect the probable intent of Congress.
p.001589: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001589:
p.001589:
p.001589:
p.001589:
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p.001589:
p.001589:
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p.001589:
p.001589: Sec. 2723 PUBLIC HEALTH SERVICE ACT 1590
p.001589:
p.001589: (2) FAILURE TO IMPLEMENT PROVISIONS.—In the case of a determination by the Secretary that a State has failed to
p.001589: sub- stantially enforce a provision (or provisions) in this part with respect to health insurance issuers in
p.001589: the State, the Secretary shall enforce such provision (or provisions) under subsection (b) insofar as they relate to
p.001589: the issuance, sale, renewal, and offer- ing of health insurance coverage in connection with group health plans
p.001589: or individual health insurance coverage in such State.
p.001589: (b) SECRETARIAL ENFORCEMENT AUTHORITY.—
p.001589: (1) LIMITATION.—The provisions of this subsection shall apply to enforcement of a provision (or provisions) of
p.001589: this part only—
p.001589:
p.001589:
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p.001589:
p.001589: January 30, 2020
...

p.001697: SEC. 3101. ø300kk¿ DATA COLLECTION, ANALYSIS, AND QUALITY.
p.001697: (a) DATA COLLECTION.—
p.001697: (1) IN GENERAL.—The Secretary shall ensure that, by not later than 2 years after the date of enactment of this
p.001697: title, any federally conducted or supported health care or public health program, activity or survey (including
p.001697: Current Population Sur- veys and American Community Surveys conducted by the Bu-
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001697:
p.001697:
p.001697:
p.001697:
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p.001697:
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p.001697: C:\XML\SSA-MERGED.XML
p.001697:
p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
p.001697:
p.001697:
p.001697:
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p.001697:
p.001697:
p.001697: January 30, 2020
p.001697:
p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001697:
p.001697:
p.001697:
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p.001697:
p.001697:
p.001699: 1699
p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
p.001699:
p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
p.001699: activity, the Secretary shall analyze data collected under paragraph (a) to detect and monitor trends in
p.001699: health disparities (as defined for purposes of section 485E) at the Federal and State levels.
p.001699: (c) DATA REPORTING AND DISSEMINATION.—
p.001699: (1) IN GENERAL.—The Secretary shall make the analyses described in (b) available to—
p.001699: (A) the Office of Minority Health;
p.001699: (B) the National Center on Minority Health and Health Disparities;
p.001699: (C) the Agency for Healthcare Research and Quality;
p.001699: (D) the Centers for Disease Control and Prevention;
p.001699: (E) the Centers for Medicare & Medicaid Services;
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p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
p.000267: (2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under this subsection shall be expended to supplement, and not
p.000267: sup- plant, the expenditures of the health center and the value of in kind contributions for the
p.000267: delivery of services to the popu- lation described in paragraph (1).
p.000267: (3) CONSULTATION WITH RESIDENTS.—The Secretary may not make a grant under paragraph (1) unless, with
p.000267: respect to the residents of the public housing involved, the applicant for the grant—
p.000267: (A) has consulted with the residents in the prepara- tion of the application for the grant; and
p.000267: (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the
p.000267: program carried out with the grant.
p.000267: (j) ACCESS GRANTS.—
p.000267: (1) IN GENERAL.—The Secretary may award grants to eligi- ble health centers with a substantial number of
p.000267: clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services
p.000267: for such clients with lim- ited English speaking proficiency.
p.000267: (2) ELIGIBLE HEALTH CENTER.—In this subsection, the term ‘‘eligible health center’’ means an entity that—
p.000267: (A) is a health center as defined under subsection (a);
p.000267: (B) provides health care services for clients for whom English is a second language; and
p.000267: (C) has exceptional needs with respect to linguistic ac- cess or faces exceptional challenges with respect to
p.000267: lin- guistic access.
p.000267: (3) GRANT AMOUNT.—The amount of a grant awarded to a center under this subsection shall be determined by the
p.000267: Ad- ministrator. Such determination of such amount shall be based on the number of clients for whom English is
p.000267: a second lan- guage that is served by such center, and larger grant amounts shall be awarded to centers serving
p.000267: larger numbers of such cli- ents.
p.000267:
p.000267:
p.000267:
p.000267:
p.000267: January 30, 2020
p.000267: 31 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amend- ment to
p.000267: strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such, the amendment has not been
p.000267: carried out above.
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000267:
p.000267:
p.000267:
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p.000267:
p.000267: Sec. 330 PUBLIC HEALTH SERVICE ACT 268
p.000267:
p.000267: (4) USE OF FUNDS.—An eligible health center that receives a grant under this subsection may use funds received
p.000267: through such grant to—
p.000267: (A) provide translation, interpretation, and other such services for clients for whom English is a second language,
...

p.000267: (B) compensate bilingual or multilingual staff for lan- guage assistance services provided by the staff for such
p.000267: cli- ents.
p.000267: (5) APPLICATION.—An eligible health center desiring a grant under this subsection shall submit an
p.000267: application to the Secretary at such time, in such manner, and containing such information as the Secretary
p.000267: may reasonably require, includ- ing—
p.000267:
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p.000267: (A) an estimate of the number of clients that the cen- ter serves for whom English is a second language;
p.000267: (B) the ratio of the number of clients for whom English is a second language to the total number of
p.000267: clients served by the center;
p.000267: (C) a description of any language assistance services that the center proposes to provide to aid clients for
p.000267: whom English is a second language; and
p.000267: (D) a description of the exceptional needs of such cen- ter with respect to linguistic access or a description of the
p.000267: exceptional challenges faced by such center with respect to linguistic access.
p.000267: (6) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, in
p.000267: addition to any funds authorized to be appropriated or appropriated for health centers under any other subsection of
p.000267: this section, such sums as may be necessary for each of fiscal years 2002 through 2006.
p.000267: (k) APPLICATIONS.—
p.000267: (1) SUBMISSION.—No grant may be made under this sec- tion unless an application therefore is submitted
p.000267: to, and ap- proved by, the Secretary. Such an application shall be sub- mitted in such form and manner and
p.000267: shall contain such infor- mation as the Secretary shall prescribe.
p.000267: (2) DESCRIPTION OF UNMET NEED.—An application for a grant under subparagraph (A) or (B) of subsection (e)(1)
p.000267: or sub- section (e)(6) for a health center shall include—
p.000267: (A) a description of the unmet need for health services in the catchment area of the center;
p.000267: (B) a demonstration by the applicant that the area or the population group to be served by the applicant has
p.000267: a shortage of personal health services;
p.000267: (C) a demonstration that the center will be located so that it will provide services to the greatest number of
p.000267: indi- viduals residing in the catchment area or included in such population group; and
p.000267: (D) in the case of an application for a grant pursuant to subsection (e)(6), a demonstration that the
p.000267: applicant has consulted with appropriate State and local government
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000267:
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p.000667: lifespan. The cen- ters, as a group, shall conduct research including the fields of developmental
p.000667: neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral
p.000667: psychology, and clinical psychology.
p.000667: (3) SERVICES FOR PATIENTS.—
p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000667: samples.
p.000667: (d) PUBLIC INPUT.—The Director shall under subsection (a)(1) provide for means through which the public can
p.000667: obtain information
p.000667: As Amended Through P.L. 116-94, Enacted December 20, 2019
...

p.000761: the responsi- bility of the heads of the agencies for the approval of spe- cific programs or projects, or for
p.000761: other details of the daily administration of such activities, in accordance with the plan and budget; and
p.000761: (H) promote coordination and collaboration among the agencies conducting or supporting minority health or other health
p.000761: disparities research.
p.000761: (2) CERTAIN COMPONENTS OF PLAN AND BUDGET.—With re- spect to health disparities research activities of the
p.000761: agencies of the National Institutes of Health, the Director of the Institute shall ensure that the plan and budget
p.000761: under paragraph (1) pro- vide for—
p.000761: (A) basic research and applied research, including re- search and development with respect to products;
p.000761: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000761:
p.000761:
p.000761:
p.000761:
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p.000761:
p.000761: Sec. 464z–3 PUBLIC HEALTH SERVICE ACT 762
p.000761:
p.000761: (B) research that is conducted by the agencies;
p.000761: (C) research that is supported by the agencies;
p.000761: (D) proposals developed pursuant to solicitations by the agencies and for proposals developed independently
p.000761: of such solicitations; and
p.000761: (E) behavioral research and social sciences research, which may include cultural and linguistic research in each
p.000761: of the agencies.
p.000761: (3) MINORITY HEALTH DISPARITIES RESEARCH.—The plan and budget under paragraph (1) shall include a separate
p.000761: state- ment of the plan and budget for minority health disparities re- search.
p.000761: (g) PARTICIPATION IN CLINICAL RESEARCH.—The Director of the Institute shall work with the Director of NIH
p.000761: and the directors of the agencies of the National Institutes of Health to carry out the provisions of
p.000761: section 492B that relate to minority groups.
p.000761: (h) RESEARCH ENDOWMENTS.—
p.000761: (1) IN GENERAL.—The Director of the Institute may carry out a program to facilitate minority health disparities
p.000761: research and other health disparities research by providing for research endowments—
p.000761: (1) at centers of excellence under section 736; and
p.000761: (2) at centers of excellence under section 464z–4. 48
p.000761: (2) ELIGIBILITY.—The Director of the Institute may provide for a research endowment under paragraph (1) only if the
p.000761: insti- tution involved meets the following conditions:
p.000761: (A) The institution does not have an endowment that is worth in excess of an amount equal to 50 percent of the
p.000761: national median of endowment funds at institutions that conduct similar biomedical research or training of
p.000761: health professionals.
p.000761: (B) The application of the institution under paragraph
p.000761: (1) regarding a research endowment has been rec- ommended pursuant to technical and scientific peer
p.000761: review and has been approved by the advisory council under sub- section (j).
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p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
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p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
p.000883: (e) CONDITION.—An applicant for a grant or cooperative agree- ment under subsection (a) shall demonstrate to the
p.000883: Secretary that the application complies with the State-sponsored statewide early intervention and prevention
p.000883: strategy as developed under section 520E and the applicant has the support of the local community and relevant
p.000883: public health officials.
p.000883: (f) SPECIAL POPULATIONS.—In awarding grants and cooperative agreements under subsection (a), the Secretary shall
p.000883: ensure that such awards are made in a manner that will focus on the needs of communities or groups
p.000883: that experience high or rapidly rising rates of suicide.
p.000883:
p.000883:
p.000883:
p.000883:
p.000883: January 30, 2020
p.000883: 11 So in law. Probably should include ‘‘and’’ after the semicolon at the end of paragraph (9). See
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p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001049: SEC. 759. ø294i¿ PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE.
p.001049: (a) IN GENERAL.—The Secretary may make awards of grants, cooperative agreements, and contracts to
p.001049: health professions schools, hospices, tribal health programs (as defined in section 4 of the Indian Health Care
p.001049: Improvement Act), and other public and nonprofit private entities for the development and implementation of
p.001049: programs to provide education and training to health care pro- fessionals in pain care.
p.001049: (b) CERTAIN TOPICS.—An entity receiving an award under this section shall develop a comprehensive education and
p.001049: training plan that includes information and education on—
p.001049: (1) recognized means for assessing, diagnosing, preventing, treating, and managing pain and related signs and symptoms,
p.001049: including non-addictive medical products and non-pharmaco- logic treatments and the medically appropriate
p.001049: use of con- trolled substances;
p.001049: (2) applicable Federal, State, and local laws, regulations, rules, and policies on controlled substances,
p.001049: including opioids;
p.001049: (3) interdisciplinary approaches to the delivery of pain care, including delivery through specialized
p.001049: centers providing comprehensive pain care treatment expertise, integrated, evi- dence-based pain management,
p.001049: and, as appropriate, non- pharmacotherapy;
p.001049: (4) cultural, linguistic, literacy, geographic, and other bar- riers to care in underserved populations;
p.001049: (5) recent findings, developments, and advancements in pain care research and the provision of pain care,
p.001049: which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and
p.001049: (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which
p.001049: may include best practices related to screening for opioid use disorders, training on screening, brief
p.001049: intervention, and referral to treat-
p.001049: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001049:
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p.001051: 1051
p.001051: PUBLIC HEALTH SERVICE ACT
p.001051: Sec. 760
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p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
p.001065: (1) are or will be working in a school or other pre-kinder- garten, elementary, or secondary education
p.001065: setting;
p.001065: (2) have familiarity with evidence-based methods and cul- tural and linguistic competence health care services;
p.001065: and
p.001065: (3) demonstrate financial need.
p.001065: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $30,000,000 for each of
p.001065: fiscal years 2010 through 2014 to carry out subsection (c)(1)(A) and $20,000,000 for each of fiscal
p.001065: years 2010 through 2013 to carry out subsection (c)(1)(B).
p.001065: SEC. 776. ø295f–1¿ PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
p.001065: (a) ESTABLISHMENT.—The Secretary shall establish the Public Health Workforce Loan Repayment Program
p.001065: (referred to in this section as the ‘‘Program’’) to assure an adequate supply of public health
p.001065: professionals to eliminate critical public health workforce shortages in Federal, State, local, and tribal public
p.001065: health agencies.
p.001065: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001065:
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p.001065: Sec. 776 PUBLIC HEALTH SERVICE ACT 1066
p.001065:
p.001065: (b) ELIGIBILITY.—To be eligible to participate in the Program, an individual shall—
p.001065: (1)(A) be accepted for enrollment, or be enrolled, as a stu- dent in an accredited academic educational
p.001065: institution in a State or territory in the final year of a course of study or pro- gram leading to a public health or
p.001065: health professions degree or certificate; and have accepted employment with a Federal, State, local, or tribal
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p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
p.001115: (5) in carrying out section 902(c), provide support to in- crease the number of researchers who are
p.001115: members of health disparity populations, and the health services research capac- ity of institutions that
p.001115: train such researchers; and
p.001115: (6) beginning with fiscal year 2003, annually submit to the Congress a report regarding prevailing disparities in
p.001115: health care delivery as it relates to racial factors and socioeconomic factors in priority populations.
p.001115: (b) RESEARCH AND DEMONSTRATION PROJECTS.—
p.001115: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor shall conduct and support research and support
p.001115: demonstra- tions to—
p.001115: (A) identify the clinical, cultural, socioeconomic, geo- graphic, and organizational factors that
p.001115: contribute to health disparities, including minority health disparity pop- ulations, which research shall include
p.001115: behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach,
p.001115: and the availability of related support services (such as cultural and linguistic services);
p.001115: (B) identify and evaluate clinical and organizational strategies to improve the quality, outcomes, and
p.001115: access to care for health disparity populations, including minority health disparity populations;
p.001115: (C) test such strategies and widely disseminate those strategies for which there is scientific evidence of
p.001115: effective- ness; and
p.001115: (D) determine the most effective approaches for dis- seminating research findings to health disparity
p.001115: popu- lations, including minority populations.
p.001115: (2) USE OF CERTAIN STRATEGIES.—In carrying out this sec- tion, the Director shall implement research
p.001115: strategies and mechanisms that will enhance the involvement of individuals who are members of minority
p.001115: health disparity populations or other health disparity populations, health services researchers who are such
p.001115: individuals, institutions that train such individ- uals as researchers, members of minority health disparity pop-
p.001115: ulations or other health disparity populations for whom the Agency is attempting to improve the quality
p.001115: and outcomes of care, and representatives of appropriate tribal or other commu- nity-based organizations with respect
p.001115: to health disparity popu- lations. Such research strategies and mechanisms may include the use of—
p.001115: (A) centers of excellence that can demonstrate, either individually or through consortia, a combination of
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p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
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p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
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p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
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p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
p.001507: (A) counseling individuals with respect to HIV/AIDS in accordance with section 2662;
p.001507: (B) testing individuals with respect to HIV/AIDS, in- cluding tests to confirm the presence of the
p.001507: disease, tests to diagnose the extent of the deficiency in the immune sys-
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000607: and which are accept- able to the Secretary. If the expert or consultant violates the agree- ment, the money spent
p.000607: by the United States for such expenses is
p.000607: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000607:
p.000609: 609
p.000609: PUBLIC HEALTH SERVICE ACT
p.000609: Sec. 402
p.000609:
p.000609: recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part
p.000609: a right of re- covery under this subparagraph.
p.000609: (e) The Director of NIH shall—
p.000609: (1) advise the agencies of the National Institutes of Health on medical applications of research;
p.000609: (2) coordinate, review, and facilitate the systematic identi- fication and evaluation of, clinically relevant
p.000609: information from research conducted by or through the national research insti- tutes;
p.000609: (3) promote the effective transfer of the information de- scribed in paragraph (2) to the health care
p.000609: community and to entities that require such information;
p.000609: (4) monitor the effectiveness of the activities described in paragraph (3); and
p.000609: (5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed
p.000609: or funded by the National Institutes of Health and intended for the gen- eral public are in a form that does
p.000609: not exceed a level of func- tional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73)
p.000609: 3.
p.000609: (f) There shall be in the National Institutes of Health an Asso- ciate Director for Prevention. The Director of NIH
p.000609: shall delegate to the Associate Director for Prevention the functions of the Director relating to the
p.000609: promotion of the disease prevention research pro- grams of the national research institutes and the
p.000609: coordination of such programs among the national research institutes and between the national research institutes
p.000609: and other public and private enti- ties, including elementary, secondary, and post-secondary schools. The
p.000609: Associate Director shall—
p.000609: (1) annually review the efficacy of existing policies and techniques used by the national research institutes
p.000609: to dissemi- nate the results of disease prevention and behavioral research programs; and
p.000609: (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to
p.000609: ensure max- imum dissemination, using advanced technologies to the max- imum extent practicable, of research
p.000609: results to such entities. ø(g) Transferred to section 461, redesignated as subsection (b)
p.000609: of such section, and amended (as so redesignated) by section 221(b)(5) of division F of Public Law
p.000609: 112–74.¿
p.000609: (h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of
p.000609: Health, shall, in conducting and supporting programs for research, research training, recruitment, and
p.000609: other activities, provide for an increase in the number of women and individuals from disadvantaged back- grounds
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p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001025: PUBLIC HEALTH SERVICE ACT
p.001025: Sec. 747A
p.001025:
p.001025: (1) IN GENERAL.—For purposes of carrying out this section (other than subsection (b)(1)(B)), there are authorized to be
p.001025: ap- propriated $125,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years
p.001025: 2011 through 2014.
p.001025: (2) TRAINING PROGRAMS.—Fifteen percent of the amount appropriated pursuant to paragraph (1) in each such
p.001025: fiscal year shall be allocated to the physician assistant training pro- grams described in subsection (a)(1)(F), which
p.001025: prepare students for practice in primary care.
p.001025: (3) INTEGRATING ACADEMIC ADMINISTRATIVE UNITS.—For purposes of carrying out subsection (b)(1)(B), there are
p.001025: author- ized to be appropriated $750,000 for each of fiscal years 2010 through 2014.
p.001025: SEC. 747A. ø293k–1¿ TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.
p.001025: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to enable such entities to provide new
p.001025: training opportuni- ties for direct care workers who are employed in long-term care set- tings such as nursing homes
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p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001027:
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p.001027:
p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
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p.001049: (a) IN GENERAL.—The Secretary may make awards of grants, cooperative agreements, and contracts to
p.001049: health professions schools, hospices, tribal health programs (as defined in section 4 of the Indian Health Care
p.001049: Improvement Act), and other public and nonprofit private entities for the development and implementation of
p.001049: programs to provide education and training to health care pro- fessionals in pain care.
p.001049: (b) CERTAIN TOPICS.—An entity receiving an award under this section shall develop a comprehensive education and
p.001049: training plan that includes information and education on—
p.001049: (1) recognized means for assessing, diagnosing, preventing, treating, and managing pain and related signs and symptoms,
p.001049: including non-addictive medical products and non-pharmaco- logic treatments and the medically appropriate
p.001049: use of con- trolled substances;
p.001049: (2) applicable Federal, State, and local laws, regulations, rules, and policies on controlled substances,
p.001049: including opioids;
p.001049: (3) interdisciplinary approaches to the delivery of pain care, including delivery through specialized
p.001049: centers providing comprehensive pain care treatment expertise, integrated, evi- dence-based pain management,
p.001049: and, as appropriate, non- pharmacotherapy;
p.001049: (4) cultural, linguistic, literacy, geographic, and other bar- riers to care in underserved populations;
p.001049: (5) recent findings, developments, and advancements in pain care research and the provision of pain care,
p.001049: which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and
p.001049: (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which
p.001049: may include best practices related to screening for opioid use disorders, training on screening, brief
p.001049: intervention, and referral to treat-
p.001049: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: 1051
p.001051: PUBLIC HEALTH SERVICE ACT
p.001051: Sec. 760
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p.001051: ment), and safe disposal options for prescription medications (including such options provided by law
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p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
p.001053: dis- tribution of mental and substance use disorders services;
p.001053: (B) an analysis of the effect of the demonstration pro- gram on the prevalence of untreated mental and substance
p.001053: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001055: 1055
p.001055: PUBLIC HEALTH SERVICE ACT
p.001055: Sec. 761
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p.001081: Standard Occu- pational Classifications of the Department of Labor for Home Health Aides [31–1011],
p.001081: Psychiatric Aides [31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
p.001081: (17) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001081: given that term in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
p.001081: (18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.— The term ‘‘frontier health professional shortage area’’
p.001081: means an area—
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p.001081: (A) with a population density less than 6 persons per square mile within the service area; and
p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001081:
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p.001083: 1083
p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
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p.001141: (iii) practical methods for reducing preventable hospital admissions and readmissions;
p.001141: (G) expand demonstration projects for improving the quality of children’s health care and the use of
p.001141: health in- formation technology, such as through Pediatric Quality Improvement Collaboratives and Learning
p.001141: Networks, con- sistent with provisions of section 1139A of the Social Secu- rity Act for assessing and improving
p.001141: quality, where appli- cable;
p.001141: (H) identify and mitigate hazards by—
p.001141: (i) analyzing events reported to patient safety re- porting systems and patient safety organizations; and
p.001141: (ii) using the results of such analyses to develop scientific methods of response to such events;
p.001141: (I) include the conduct of systematic reviews of exist- ing practices that improve the quality, safety,
p.001141: and effi- ciency of health care delivery, as well as new research on improving such practices; and
p.001141: (J) include the examination of how to measure and evaluate the progress of quality and patient safety
p.001141: activi- ties.
p.001141: (d) DISSEMINATION OF RESEARCH FINDINGS.—
p.001141: (1) PUBLIC AVAILABILITY.—The Director shall make the re- search findings of the Center available to the public
p.001141: through multiple media and appropriate formats to reflect the varying needs of health care providers and
p.001141: consumers and diverse lev- els of health literacy.
p.001141: (2) LINKAGE TO HEALTH INFORMATION TECHNOLOGY.—The Secretary shall ensure that research findings and
p.001141: results gen- erated by the Center are shared with the Office of the National
p.001141: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001141: Sec. 934 PUBLIC HEALTH SERVICE ACT 1142
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p.001141: Coordinator of Health Information Technology and used to in- form the activities of the health information
p.001141: technology exten- sion program under section 3012, as well as any relevant standards, certification
p.001141: criteria, or implementation specifica- tions.
p.001141: (e) PRIORITIZATION.—The Director shall identify and regularly update a list of processes or systems on
p.001141: which to focus research and dissemination activities of the Center, taking into account—
p.001141: (1) the cost to Federal health programs;
p.001141: (2) consumer assessment of health care experience;
p.001141: (3) provider assessment of such processes or systems and opportunities to minimize distress and injury to
p.001141: the health care workforce;
p.001141: (4) the potential impact of such processes or systems on health status and function of patients,
p.001141: including vulnerable populations including children;
p.001141: (5) the areas of insufficient evidence identified under sub- section (c)(2)(B); and
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p.001147: pro- viders in educating patients, caregivers, and authorized representatives concerning the relative safety,
p.001147: relative ef- fectiveness (including possible health outcomes and impact on functional status), and relative cost
p.001147: of treatment or, where appropriate, palliative care options;
p.001147: (B) to test such materials to ensure such materials are balanced and evidence based in aiding health care pro-
p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and
p.001147: (C) to educate providers on the use of such materials, including through academic curricula.
p.001147: (2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient decision aids developed and produced pursuant to a
p.001147: grant or contract under paragraph (1)—
p.001147: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed
p.001147: decision- making with health care providers;
p.001147: (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and man- ner
p.001147: that is age-appropriate and can be adapted for pa- tients, caregivers, and authorized representatives
p.001147: from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and
p.001147: diverse levels of health literacy;
p.001147: (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option
p.001147: over an- other; and
p.001147: (D) shall address health care decisions across the age span, including those affecting vulnerable
p.001147: populations in- cluding children.
p.001147: (3) DISTRIBUTION.—The Director shall ensure that patient decision aids produced with grants or contracts under
p.001147: this sec- tion are available to the public.
p.001147: (4) NONDUPLICATION OF EFFORTS.—The Director shall en- sure that the activities under this section of
p.001147: the Agency and other agencies, including the Centers for Disease Control and
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001149: PUBLIC HEALTH SERVICE ACT
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p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: PUBLIC HEALTH SERVICE ACT
p.001169: Sec. 1109
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p.001169: January 30, 2020
p.001169: (A) the collection, delivery, receipt, and screening of specimens; and
p.001169: (B) the diagnosis of heritable disorders in newborns.
p.001169: (b) ELIGIBLE ENTITY.—In this section, the term ‘‘eligible entity’’ means—
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p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
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p.000001: opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives
p.000001: ob- tained either from the raw material or from the various alkaloids; Indian hemp and its various
p.000001: derivatives, compounds, and prepara- tions, and peyote in its various forms; isonipecaine and its deriva-
p.000001: 1
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 201 PUBLIC HEALTH SERVICE ACT 2
p.000001:
p.000001: tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code);
p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
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p.000001: any individual working under the supervision of a health care professional, that relate to—
p.000001: (A) the diagnosis, prevention, or treatment of any human disease or impairment; or
p.000001: (B) the assessment or care of the health of human beings.
p.000001: (e) EFFECTIVE DATE.—
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 45 PUBLIC HEALTH SERVICE ACT Sec. 227
p.000001:
p.000001: (1) IN GENERAL.—This section shall take effect 90 days after the date of the enactment of the Pandemic
p.000001: and All-Haz- ards Preparedness and Advancing Innovation Act of 2019.
p.000001: (2) APPLICATION.—This section shall apply to a claim for harm only if the act or omission that caused
p.000001: such harm oc- curred on or after the effective date described in paragraph (1).
p.000001: ADMINISTRATION OF GRANTS IN CERTAIN MULTIGRANT PROJECTS
p.000001: SEC. 226. ø235¿ For the purpose of facilitating the administra- tion of, and expediting the carrying out of the
p.000001: purposes of, the pro- grams established by titles VII, VIII, and IX, and sections 304, 314(a), 314(b),
p.000001: 314(c), 314(d), and 314(e) of this Act in situations in which grants are sought or made under two or more of
p.000001: such pro- grams with respect to a single project, the Secretary is authorized to promulgate regulations—
p.000001: (1) under which the administrative functions under such programs with respect to such project will be
p.000001: performed by a single administrative unit which is the administrative unit charged with the administration of
p.000001: any of such programs or is the administrative unit charged with the supervision of two or more of such programs;
p.000001: (2) designed to reduce the number of applications, reports, and other materials required under such programs to
p.000001: be sub- mitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the extent
p.000001: feasible), the data and information required to be contained in such applications, reports, and other materials; and
p.000001: (3) under which inconsistent or duplicative requirements imposed by such programs will be revised and
p.000001: made uniform with respect to such project;
p.000001: except that nothing in this section shall be construed to authorize the Secretary to waive or suspend, with
p.000001: respect to any such project, any requirement with respect to any of such programs if such re- quirement is
p.000001: imposed by law or by any regulation required by law.
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p.000001:
p.000001: January 30, 2020
p.000001: ORPHAN PRODUCTS BOARD
p.000001: SEC. 227. ø236¿ (a) There is established in the Department of Health and Human Services a board for the
p.000001: development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or
p.000001: conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for
...

p.000017:
p.000017: the circumstances under which such payments are reason- able and necessary.
p.000017: (B) MINORS.—With respect to an eligible individual who is a minor, the Secretary may consider the provisions of
p.000017: section 8113 of title 5, United States Code, and any im- plementing regulations, in determining the amount of pay- ment
p.000017: under subsection (a) and the circumstances under which such payments are reasonable and necessary.
p.000017: (4) TREATMENT OF SELF-EMPLOYMENT INCOME.—For pur- poses of this section, the term ‘‘employment income’’
p.000017: includes income from self-employment.
p.000017: (c) LIMITATIONS.—
p.000017: (1) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (A) IN GENERAL.—Any compensation under subsection
p.000017: (a) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: gov- ernmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to
p.000017: pay com- pensation for loss of employment income or to provide dis- ability or retirement benefits.
p.000017: (B) RELATION TO OTHER OBLIGATIONS.—Compensation under subsection (a) shall not be made to an eligible indi- vidual
p.000017: to the extent that the total of amounts paid to the individual under such subsection and under the other
p.000017: obli- gations referred to in subparagraph (A) is an amount that exceeds the rate specified in subsection (b)(1). If
p.000017: under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this
p.000017: paragraph, be deemed to be received over multiple years rather than received in a single year. The
p.000017: Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple
p.000017: years.
p.000017: (2) NO BENEFITS IN CASE OF DEATH.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employ- ment income subsequent to the receipt, by the survivor or sur- vivors of an eligible individual, of
p.000017: benefits under section 266 for death.
p.000017: (3) LIMIT ON TOTAL BENEFITS.—
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B)—
p.000017: (i) total compensation paid to an individual under subsection (a) shall not exceed $50,000 for any year; and
p.000017:
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p.000017: January 30, 2020
p.000017: (ii) the lifetime total of such compensation for the individual may not exceed an amount equal to the amount
p.000017: authorized to be paid under section 266.
p.000017: (B) PERMANENT AND TOTAL DISABILITY.—The limita- tion under subparagraph (A)(ii) does not apply in the case of
p.000017: an eligible individual who is determined to have a cov- ered injury or injuries meeting the definition
p.000017: of disability in section 216(i) of the Social Security Act (42 U.S.C. 416(i)).
p.000017: (4) WAITING PERIOD.—
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: (i) IN GENERAL.—Any payment under paragraph
p.000017: (1) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: governmental entity, private insurance carrier, or em- ployer), under any other law or contractual agreement, to pay
p.000017: compensation for loss of employment income or to provide disability benefits, retirement benefits, life insurance
p.000017: benefits on behalf of dependents under the age of 18, or death benefits.
p.000017: (ii) RELATION TO OTHER OBLIGATIONS.—Payments under paragraph (1) shall not be made to with respect to an eligible
p.000017: individual to the extent that the total of amounts paid with respect to the individual under such paragraph
p.000017: and under the other obligations re- ferred to in clause (i) is an amount that exceeds the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 67 PUBLIC HEALTH SERVICE ACT Sec. 271
p.000017:
p.000017: rate of payment that applies under paragraph (2). If under any such other obligation a lump-sum payment is
p.000017: made, such payment shall, for purposes of this sub- paragraph, be deemed to be received over multiple years
p.000017: rather than received in a single year. The Sec- retary may, in the discretion of the Secretary, deter-
p.000017: mine how to apportion such payment over multiple years.
p.000017: (c) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) or (b) shall be in addition to
p.000017: any amounts re- ceived by an eligible individual under section 264.
p.000017: SEC. 267. ø239f¿ ADMINISTRATION.
p.000017: (a) ADMINISTRATION BY AGREEMENT WITH OTHER AGENCY OR AGENCIES.—The Secretary may administer any or all of
p.000017: the provi- sions of this part through Memorandum of Agreement with the head of any appropriate Federal
p.000017: agency.
p.000017: (b) REGULATIONS.—The head of the agency administering this part or provisions thereof (including any
p.000017: agency head admin- istering such Act or provisions through a Memorandum of Agree- ment under subsection
p.000017: (a)) may promulgate such implementing regulations as may be found necessary and appropriate. Initial im- plementing
p.000017: regulations may be interim final regulations.
p.000017: SEC. 268. ø239g¿ AUTHORIZATION OF APPROPRIATIONS.
p.000017: For the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for
p.000017: each of the fiscal years 2003 through 2007, to remain available until expended, including administrative costs and
p.000017: costs of provision and payment of benefits. The Secretary’s payment of any benefit under section 264,
p.000017: 265, or 266 shall be subject to the availability of appropria- tions under this section.
p.000017: SEC. 269. ø239h¿ RELATIONSHIP TO OTHER LAWS.
p.000017: Except as explicitly provided herein, nothing in this part shall be construed to override or limit any rights an
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p.000017: January 30, 2020
p.000017: 5 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat. 2205).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017:
p.000017: 89 PUBLIC HEALTH SERVICE ACT Sec. 310A
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p.000017: January 30, 2020
p.000017: would be promoted by a conference, the Secretary may invite as many of such health authorities and officials
p.000017: of other State or local public or private agencies, institutions, or organizations to confer as he deems
p.000017: necessary or proper. Upon the application of health authorities of five or more States it shall be the
p.000017: duty of the Sec- retary to call a conference of all State health authorities joining in the request. Each State
p.000017: represented at any conference shall be en- titled to a single vote. Whenever at any such conference matters re- lating
p.000017: to mental health are to be discussed, the mental health au- thorities of the respective States shall be invited to
p.000017: attend.
p.000017: (b) From time to time the Secretary shall issue information re- lated to public health, in the form of publications or
p.000017: otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United
p.000017: States and other countries and other perti- nent health information for the use of persons and institutions con- cerned
p.000017: with health services.
p.000017: SEC. 310A. ø242s¿ CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN’S HEALTH.
p.000017: (a) ESTABLISHMENT.—There is established within the Office of the Director of the Centers for Disease Control and
p.000017: Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the
p.000017: ‘‘Office’’). The Office shall be headed by a direc- tor who shall be appointed by the Director of such Centers.
p.000017: (b) PURPOSE.—The Director of the Office shall—
p.000017: (1) report to the Director of the Centers for Disease Con- trol and Prevention on the current level of the
p.000017: Centers’ activity regarding women’s health conditions across, where appro- priate, age, biological, and
p.000017: sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and
p.000017: professional education, services, and treatment;
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p.000017: January 30, 2020
p.000017:
p.000017: GRANTS FOR COMPREHENSIVE HEALTH PLANNING AND PUBLIC HEALTH SERVICES
p.000017: Grants to States for Comprehensive State Health Planning SEC. 314. ø246¿ (a)(1) AUTHORIZATION.—In order to assist
p.000017: the
p.000017: States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized
p.000017: during the pe- riod beginning July 1, 1966, and ending June 30, 1973, to make grants to States which
p.000017: have submitted, and had approved by the Secretary, State plans for comprehensive State health planning.
p.000017: For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000
p.000017: for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968,
p.000017: $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970,
p.000017: $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972,
p.000017: $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.
p.000017: (2) STATE PLANS FOR COMPREHENSIVE STATE HEALTH PLAN- NING.—In order to be approved for purposes of
p.000017: this subsection, a State plan for comprehensive State health planning must—
p.000017: (A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental
p.000017: agency, as the sole agency for administering or supervising the adminis- tration of the State’s health
p.000017: planning functions under the plan;
p.000017: (B) provide for the establishment of a State health plan- ning council, which shall include
p.000017: representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in
p.000017: such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the
p.000017: individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the
p.000017: representative of the hospitals or other health care facilities of such Department which are located in such
p.000017: State) and nongovernmental organi- zations and groups concerned with health (including represen- tation of the regional
p.000017: medical program or programs included in whole or in part within the State) and of consumers of health
p.000017: services, to advise such State agency in carrying out its func- tions under the plan, and a majority of the
p.000017: membership of such council shall consist of representatives of consumers of health services;
p.000017: (C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the
p.000017: Secretary, are designed to provide for comprehensive State planning for health services (both public and
p.000017: private and including home health care), including the facilities and persons required for the provision of
p.000017: such services, to meet the health needs of the people of the State and including environmental considerations as they
p.000017: relate to public health;
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p.000129: (E) publicly identify the methods used to identify preg- nancy-associated deaths and pregnancy-related deaths in
p.000129: accordance with this section.
p.000129: (4) CONFIDENTIALITY.—States, Indian tribes, and tribal or- ganizations participating in the program described in this
p.000129: sub- section shall establish confidentiality protections to ensure, at a minimum, that—
p.000129: (A) there is no disclosure by the maternal mortality re- view committee, including any individual members of the
p.000129: committee, to any person, including any government offi- cial, of any identifying information about any
p.000129: specific ma- ternal mortality case; and
p.000129: (B) no information from committee proceedings, in- cluding deliberation or records, is made public unless spe-
p.000129: cifically authorized under State and Federal law.
p.000129: (5) REPORTS TO CDC.—For fiscal year 2019, and each sub- sequent fiscal year, each maternal mortality review
p.000129: committee participating in the program described in this subsection shall submit to the Director of the Centers
p.000129: for Disease Control and Prevention a report that includes—
p.000129: (A) data, findings, and any recommendations of such committee; and
p.000129: (B) as applicable, information on the implementation during such year of any recommendations submitted by
p.000129: the committee in a previous year.
p.000129: (6) STATE PARTNERSHIPS.—States may partner with one or more neighboring States to carry out the activities
p.000129: under this subparagraph. With respect to the States in such a partner- ship, any requirement under this
p.000129: subparagraph relating to the reporting of information related to such activities shall be deemed to be
p.000129: fulfilled by each such State if a single such report is submitted for the partnership.
p.000129: (7) APPROPRIATE MECHANISMS FOR INDIAN TRIBES AND TRIB- AL ORGANIZATIONS.—The Secretary, in consultation with
p.000129: Indian tribes, shall identify and establish appropriate mechanisms for Indian tribes and tribal organizations to
p.000129: demonstrate, report data, and conduct the activities as required for participation in the program described in
p.000129: this subsection. Such mechanisms may include technical assistance with respect to grant applica- tion and
p.000129: submission procedures, and award management ac- tivities.
p.000129: (8) RESEARCH AVAILABILITY.—The Secretary shall develop a process to ensure that data collected under
p.000129: paragraph (5) is made available, as appropriate and practicable, for research purposes, in a manner that
p.000129: protects individually identifiable or potentially identifiable information and that is consistent with State and
p.000129: Federal privacy law.
p.000129: (e) DEFINITIONS.—In this section—
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000129:
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p.000129:
p.000129: Sec. 317L PUBLIC HEALTH SERVICE ACT 130
p.000129:
p.000129: (1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the
p.000129: Indian Self- Determination and Education Assistance Act;
p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
...

p.000165:
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p.000165: January 30, 2020
p.000165: (i) For no more than one of each of the first 2 fis- cal years immediately following a fiscal year in which an entity
p.000165: experienced a failure described in subpara- graph (A) or (B) of paragraph (5), an amount equal to 10 percent of
p.000165: the amount the entity was eligible to re- ceive for the respective fiscal year.
p.000165: (ii) For no more than one of the first 2 fiscal years immediately following the third consecutive fiscal year in which
p.000165: an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of
p.000165: the amount the entity was eligible to receive for the respective fiscal year.
p.000165: (B) SEPARATE ACCOUNTING.—Each failure described in subparagraph (A) or (B) of paragraph (5) shall be treated
p.000165: as a separate failure for purposes of calculating amounts withheld under subparagraph (A).
p.000165: (7) REALLOCATION OF AMOUNTS WITHHELD.—
p.000165: (A) IN GENERAL.—The Secretary shall make amounts withheld under paragraph (6) available for making awards under
p.000165: section 319C–2 to entities described in subsection (b)(1) of such section.
p.000165: (B) PREFERENCE IN REALLOCATION.—In making awards under section 319C–2 with amounts described in subpara- graph (A),
p.000165: the Secretary shall give preference to eligible entities (as described in section 319C–2(b)(1)) that are
p.000165: lo- cated in whole or in part in States from which amounts have been withheld under paragraph (6).
p.000165: (8) WAIVE OR REDUCE WITHHOLDING.—The Secretary may waive or reduce the withholding described in paragraph (6),
p.000165: for a single entity or for all entities in a fiscal year, if the Sec- retary determines that mitigating
p.000165: conditions exist that justify the waiver or reduction.
p.000165: (h) FUNDING.—
p.000165: (1) AUTHORIZATION OF APPROPRIATIONS.—
p.000165: (A) IN GENERAL.—For the purpose of carrying out this section, there is authorized to be
p.000165: appropriated
p.000165: $685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority
p.000165: of the Secretary to make awards pursuant to paragraphs (4) and (5)).
p.000165: (B) REQUIREMENT FOR STATE MATCHING FUNDS.—Be- ginning in fiscal year 2009, in the case of any State or con-
p.000165: sortium of two or more States, the Secretary may not award a cooperative agreement under this section
p.000165: unless the State or consortium of States agree that, with respect to the amount of the cooperative
p.000165: agreement awarded by the Secretary, the State or consortium of States will make available (directly or through
p.000165: donations from public or pri- vate entities) non-Federal contributions in an amount equal to—
p.000165: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000165:
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p.000165:
p.000165: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 166
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p.000175: (2) SUNSET.—The authority under this subsection shall ex- pire on September 30, 2023.
p.000175: SEC. 319D. ø247d–4¿ FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
p.000175: (a) IN GENERAL.—
p.000175: (1) FINDINGS.—Congress finds that the Centers for Disease Control and Prevention has an essential role in
p.000175: defending against and combatting public health threats domestically and abroad and requires secure and modern
p.000175: facilities, and ex- panded, improved, and appropriately maintained capabilities related to bioterrorism and
p.000175: other public health emergencies, sufficient to enable such Centers to conduct this important mission.
p.000175: (2) FACILITIES.—
p.000175: (A) IN GENERAL.—The Director of the Centers for Dis- ease Control and Prevention may design, construct, and
p.000175: equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings,
p.000175: scientific com- munication facilities, transshipment complexes, secured and isolated parking structures,
p.000175: office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to
p.000175: better conduct the capacities de- scribed in section 319A, and for supporting public health activities.
p.000175: (B) MULTIYEAR CONTRACTING AUTHORITY.—For any project of designing, constructing, equipping, or renovating any
p.000175: facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into
p.000175: a single contract or related contracts that collectively in- clude the full scope of the project, and the
p.000175: solicitation and contract shall contain the clause ‘‘availability of funds’’ found at section 52.232–18 of title
p.000175: 48, Code of Federal Reg- ulations.
p.000175: (3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DIS- EASE CONTROL AND PREVENTION.—The Secretary shall
p.000175: expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control
p.000175: and Prevention relating to
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000175:
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p.000177: PUBLIC HEALTH SERVICE ACT
p.000177: Sec. 319D
p.000177:
p.000177: preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be
p.000177: carried out under the preceding sentence include—
p.000177: (A) expanding or enhancing the training of personnel;
p.000177: (B) improving communications facilities and networks, including delivery of necessary information to rural areas;
p.000177: (C) improving capabilities for public health surveil- lance and reporting activities, taking into account the
p.000177: inte- grated system or systems of public health alert commu- nications and surveillance networks under
p.000177: subsection (b); and
p.000177:
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p.000231: to be appropriated
p.000231:
p.000231:
p.000231:
p.000231:
p.000231: January 30, 2020
p.000231: 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814).
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000231:
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p.000233: PUBLIC HEALTH SERVICE ACT
p.000233: Sec. 319I
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p.000233:
p.000233: January 30, 2020
p.000233: such sums as may be necessary for each of the fiscal years 2002 through 2006.
p.000233: SEC. 319I. ø247d–7b¿ EMERGENCY SYSTEM FOR ADVANCE REGISTRA- TION OF VOLUNTEER HEALTH PROFESSIONAL.
p.000233: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Pandemic and All-Hazards
p.000233: Preparedness Act, the Secretary shall link existing State verification systems to maintain a single national
p.000233: interoperable network of systems, each system being maintained by a State or group of States, for the purpose of
p.000233: verifying the credentials and licenses of health care professionals who volunteer to provide health
p.000233: services during a public health emergency. Such health care professionals may include members of the National
p.000233: Disaster Medical System, members of the Medical Re- serve Corps, and individual health care professionals.
p.000233: (b) REQUIREMENTS.—The interoperable network of systems es- tablished under subsection (a) (referred to in
p.000233: this section as the ‘‘verification network’’) shall include—
p.000233: (1) with respect to each volunteer health professional in- cluded in the verification network—
p.000233: (A) information necessary for the rapid identification of, and communication with, such professionals; and
p.000233: (B) the credentials, certifications, licenses, and rel- evant training of such individuals; and
p.000233: (2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any
p.000233: other relevant federally-sponsored or administered programs deter- mined necessary by the Secretary.
p.000233: (c) OTHER ASSISTANCE.—The Secretary may make grants and provide technical assistance to States and other public
p.000233: or nonprofit private entities for activities relating to the verification network de- veloped under subsection (a).
p.000233: (d) ACCESSIBILITY.—The Secretary shall ensure that the verification network is electronically accessible by
...

p.000323: is nearing comple- tion, the Secretary shall encourage the individual to remain in a health professional
p.000323: shortage area and to continue providing pri- mary health services.
p.000323: (ii) During the period in which a health professional is plan- ning and making the transition to
p.000323: private practice from obligated service under the Scholarship Program, the Secretary may provide assistance to the
p.000323: professional regarding such transition if the pro- fessional is remaining in a health professional
p.000323: shortage area and is continuing to provide primary health services.
p.000323: (C) In the case of entities to which participants in the Scholar- ship Program are assigned under section 333,
p.000323: the Secretary shall encourage the entities to provide options with respect to assisting the participants
p.000323: in remaining in the health professional shortage areas involved, and in continuing to provide primary
p.000323: health serv- ices, after the period of obligated service under the Scholarship Program is completed. The
p.000323: options with respect to which the Sec- retary provides such encouragement may include options regarding
p.000323: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000323:
p.000323:
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p.000323: Sec. 338A PUBLIC HEALTH SERVICE ACT 324
p.000323:
p.000323: the sharing of a single employment position in the health profes- sions by 2 or more health professionals,
p.000323: and options regarding the recruitment of couples where both of the individuals are health professionals.
p.000323: (d)(1) Subject to section 333A, in providing contracts under the Scholarship Program—
p.000323: (A) the Secretary shall consider the extent of the dem- onstrated interest of the applicants for the
p.000323: contracts in pro- viding primary health services;
p.000323: (B) the Secretary, in considering applications from individ- uals accepted for enrollment or enrolled in dental school,
p.000323: shall consider applications from all individuals accepted for enroll- ment or enrolled in any accredited
p.000323: dental school in a State; and
p.000323: (C) may consider such other factors regarding the appli- cants as the Secretary determines to be
p.000323: relevant to selecting qualified individuals to participate in such Program.
p.000323: (2) In providing contracts under the Scholarship Program, the Secretary shall give priority—
p.000323: (A) first, to any application for such a contract submitted by an individual who has previously received
p.000323: a scholarship under this section or under section 758;
p.000323: (B) second, to any application for such a contract sub- mitted by an individual who has characteristics
p.000323: that increase the probability that the individual will continue to serve in a health professional shortage
p.000323: area after the period of obligated service pursuant to subsection (f) is completed; and
p.000323: (C) third, subject to subparagraph (B), to any application for such a contract submitted by an
p.000323: individual who is from a disadvantaged background.
...

p.000327: gram is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage
p.000327: area and to continue providing primary health services.
p.000327: (ii) During the period in which a health professional is planning and making the transition to private practice
p.000327: from obligated service under the Loan Repayment Pro- gram, the Secretary may provide assistance to the
p.000327: profes- sional regarding such transition if the professional is re- maining in a health professional shortage
p.000327: area and is continuing to provide primary health services.
p.000327: (C) In the case of entities to which participants in the Loan Repayment Program are assigned under section 333, the
p.000327: Secretary shall encourage the entities to provide op- tions with respect to assisting the participants in
p.000327: remain- ing in the health professional shortage areas involved, and in continuing to provide primary health services,
p.000327: after the period of obligated service under the Loan Repayment Pro- gram is completed. The options with respect
p.000327: to which the
p.000327: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000327:
p.000327:
p.000327:
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p.000327:
p.000327: Sec. 338B PUBLIC HEALTH SERVICE ACT 328
p.000327:
p.000327: Secretary provides such encouragement may include op- tions regarding the sharing of a single employment
p.000327: posi- tion in the health professions by 2 or more health profes- sionals, and options regarding the
p.000327: recruitment of couples where both of the individuals are health professionals.
p.000327: (d)(1) Subject to section 333A, in providing contracts under the Loan Repayment Program—
p.000327: (A) the Secretary shall consider the extent of the dem- onstrated interest of the applicants for the
p.000327: contracts in pro- viding primary health services; and
p.000327: (B) may consider such other factors regarding the appli- cants as the Secretary determines to be
p.000327: relevant to selecting qualified individuals to participate in such Program.
p.000327: (2) In providing contracts under the Loan Repayment Program, the Secretary shall give priority—
p.000327: (A) to any application for such a contract submitted by an individual whose training is in a health profession or
p.000327: specialty determined by the Secretary to be needed by the Corps;
p.000327: (B) to any application for such a contract submitted by an individual who has (and whose spouse, if any, has)
p.000327: characteris- tics that increase the probability that the individual will con- tinue to serve in a health
p.000327: professional shortage area after the period of obligated service pursuant to subsection (f) is com-
p.000327: pleted; and
p.000327: (C) subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a
p.000327: disadvan- taged background.
p.000327: (e) APPROVAL REQUIRED FOR PARTICIPATION.—An individual be- comes a participant in the Loan Repayment Program only
p.000327: upon the Secretary and the individual entering into a written contract de- scribed in subsection (f).
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p.000353: the system either directly provides or ensures the provision of a broad range of culturally competent services,
p.000353: as appropriate, including primary, secondary, and tertiary services, as well as substance abuse treat- ment and mental
p.000353: health services; and
p.000353: (ii) direct patient care and service expansions to fill identified or documented gaps within an integrated
p.000353: delivery system.
p.000353: (B) SPECIFIC USES.—The following are examples of purposes for which a grantee may use grant funds under
p.000353: this section, when such use meets the conditions stated in subparagraph (A):
p.000353: (i) Increases in outreach activities and closing gaps in health care service.
p.000353: (ii) Improvements to case management.
p.000353: (iii) Improvements to coordination of transpor- tation to health care facilities.
p.000353: (iv) Development of provider networks and other innovative models to engage physicians in voluntary efforts
p.000353: to serve the medically underserved within a community.
p.000353: (v) Recruitment, training, and compensation of necessary personnel.
p.000353: (vi) Acquisition of technology for the purpose of co- ordinating care.
p.000353: (vii) Improvements to provider communication, in- cluding implementation of shared information systems or shared
p.000353: clinical systems.
p.000353: (viii) Development of common processes for deter- mining eligibility for the programs provided through the
p.000353: system, including creating common identification cards and single sliding scale discounts.
p.000353: (ix) Development of specific prevention and dis- ease management tools and processes.
p.000353: (x) Translation services.
p.000353: (xi) Carrying out other activities that may be ap- propriate to a community and that would increase ac- cess
p.000353: by the uninsured to health care, such as access initiatives for which private entities provide non-Fed-
p.000353: eral contributions to supplement the Federal funds provided through the grants for the initiatives.
p.000353: (2) DIRECT PATIENT CARE LIMITATION.—Not more than 15 percent of the funds provided under a grant awarded
p.000353: under
p.000353: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000353:
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p.000355: PUBLIC HEALTH SERVICE ACT
p.000355: Sec. 340
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p.000355: January 30, 2020
p.000355: this section may be used for providing direct patient care and services.
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p.000363: as to assist the Sec- retary in evaluating the validity of the entity’s subsequent purchases of covered outpatient
p.000363: drugs at discounted prices.
p.000363: (C) CRITERIA.—The Secretary shall make available to all manufacturers of covered outpatient drugs a
p.000363: descrip- tion of the criteria for certification under this paragraph.
p.000363: (D) LIST OF PURCHASERS AND DISPENSERS.—The certifi- cation process developed by the Secretary under subpara-
p.000363: graph (A) shall include procedures under which each State shall, not later than 30 days after the submission
p.000363: of the descriptions under subparagraph (C), prepare and submit a report to the Secretary that contains a list of
p.000363: entities de- scribed in subparagraphs (J) and (K) of paragraph (4) that are located in the State.
p.000363: (E) RECERTIFICATION.—The Secretary shall require the recertification of entities certified pursuant to this
p.000363: para- graph on a not more frequent than annual basis, and shall require that such entities submit information to
p.000363: the Sec- retary to permit the Secretary to evaluate the validity of subsequent purchases by such entities in
p.000363: the same manner as that required under subparagraph (B).
p.000363: (8) DEVELOPMENT OF PRIME VENDOR PROGRAM.—The Sec- retary shall establish a prime vendor program under
p.000363: which covered entities may enter into contracts with prime vendors for the distribution of covered
p.000363: outpatient drugs. If a covered entity obtains drugs directly from a manufacturer, the manu- facturer shall
p.000363: be responsible for the costs of distribution.
p.000363: (9) NOTICE TO MANUFACTURERS.—The Secretary shall no- tify manufacturers of covered outpatient drugs and
p.000363: single State agencies under section 1902(a)(5) of the Social Security Act of the identities of covered
p.000363: entities under this paragraph, and of entities that no longer meet the requirements of paragraph (5) or that are
p.000363: no longer certified pursuant to paragraph (7).
p.000363: (10) NO PROHIBITION ON LARGER DISCOUNT.—Nothing in this subsection shall prohibit a manufacturer from
p.000363: charging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).
p.000363: (b) OTHER DEFINITIONS 48.—
p.000363: (1) IN GENERAL.—In this section, the terms ‘‘average man- ufacturer price’’, ‘‘covered outpatient drug’’, and
p.000363: ‘‘manufac- turer’’ have the meaning given such terms in section 1927(k) of the Social Security Act.
p.000363:
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p.000363:
p.000363: January 30, 2020
p.000363: 48 The amendment made by section 7101(b)(2)(A) of Public Law 111–148 strikes ‘‘OTHER DEFI-
p.000363: NITION’’ and all that follows through ‘‘In this section’’ and inserts ‘‘OTHER DEFINITIONS.—
p.000363: (1) IN GENERAL.—In this section’’.
p.000363: The heading of such amendment should have been to strike ‘‘OTHER DEFINITIONS’’. The amendment made by
p.000363: such section has been carried out to reflect the probable intent of Con- gress.
p.000363: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000363:
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p.000365: (2) COVERED ENTITY COMPLIANCE.—
p.000365: (A) IN GENERAL.—From amounts appropriated under paragraph (4), the Secretary shall provide for improve-
p.000365: ments in compliance by covered entities with the require- ments of this section in order to prevent diversion
p.000365: and vio- lations of the duplicate discount provision and other re- quirements specified under subsection
p.000365: (a)(5).
p.000365: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000365:
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p.000365: Sec. 340B PUBLIC HEALTH SERVICE ACT 366
p.000365:
p.000365: (B) IMPROVEMENTS.—The improvements described in subparagraph (A) shall include the following:
p.000365: (i) The development of procedures to enable and require covered entities to regularly update (at least
p.000365: annually) the information on the Internet website of the Department of Health and Human Services relat-
p.000365: ing to this section.
p.000365: (ii) The development of a system for the Secretary to verify the accuracy of information regarding covered entities
p.000365: that is listed on the website described in clause (i).
p.000365: (iii) The development of more detailed guidance describing methodologies and options available to cov- ered
p.000365: entities for billing covered outpatient drugs to State Medicaid agencies in a manner that avoids du-
p.000365: plicate discounts pursuant to subsection (a)(5)(A).
p.000365: (iv) The establishment of a single, universal, and standardized identification system by which each cov-
p.000365: ered entity site can be identified by manufacturers, distributors, covered entities, and the Secretary for
p.000365: purposes of facilitating the ordering, purchasing, and delivery of covered outpatient drugs under this
p.000365: sec- tion, including the processing of chargebacks for such drugs.
p.000365: (v) The imposition of sanctions, in appropriate cases as determined by the Secretary, additional to those
p.000365: to which covered entities are subject under sub- section (a)(5)(D), through one or more of the following actions:
p.000365:
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p.000365: January 30, 2020
p.000365: (I) Where a covered entity knowingly and in- tentionally violates subsection (a)(5)(B), the cov- ered
p.000365: entity shall be required to pay a monetary penalty to a manufacturer or manufacturers in the form of
p.000365: interest on sums for which the covered entity is found liable under subsection (a)(5)(D), such interest to
p.000365: be compounded monthly and equal to the current short term interest rate as determined by the Federal
p.000365: Reserve for the time period for which the covered entity is liable.
p.000365: (II) Where the Secretary determines a viola- tion of subsection (a)(5)(B) was systematic and egregious as
p.000365: well as knowing and intentional, re- moving the covered entity from the drug discount program under this
...

p.000371: (D) REPORT TO CONGRESS.—Not later than the end of fiscal year 2018, and the end of fiscal year 2022,
p.000371: the Sec- retary, acting through the Administrator of the Health Re- sources and Services Administration, shall submit
p.000371: a report to the Congress—
p.000371: (i) summarizing the information submitted in re- ports to the Secretary under subparagraph (B);
p.000371: (ii) describing the results of the program carried out under this section; and
p.000371: (iii) making recommendations for improvements to the program.
p.000371: (c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDU-
p.000371: CATION.—
p.000371: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for direct
p.000371: graduate expenses relating to approved graduate medical residency training programs for a fiscal year is
p.000371: equal to the product of—
p.000371: (A) the updated per resident amount for direct grad- uate medical education, as determined under
p.000371: paragraph (2); and
p.000371: (B) the average number of full-time equivalent resi- dents in the hospital’s graduate approved medical
p.000371: resi- dency training programs (as determined under section 1886(h)(4) of the Social Security Act during the
p.000371: fiscal year.
p.000371: (2) UPDATED PER RESIDENT AMOUNT FOR DIRECT GRADUATE MEDICAL EDUCATION.—The updated per resident amount for di-
p.000371: rect graduate medical education for a hospital for a fiscal year is an amount determined as follows:
p.000371: (A) DETERMINATION OF HOSPITAL SINGLE PER RESIDENT AMOUNT.—The Secretary shall compute for each hospital
p.000371: operating an approved graduate medical education pro- gram (regardless of whether or not it is a
p.000371: children’s hos- pital) a single per resident amount equal to the average (weighted by number of full-time
p.000371: equivalent residents) of the primary care per resident amount and the non-primary care per resident amount
p.000371: computed under section
p.000371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000371:
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p.000371:
p.000373: 373
p.000373: PUBLIC HEALTH SERVICE ACT
p.000373: Sec. 340E
p.000373:
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p.000373: January 30, 2020
p.000373: 1886(h)(2) of the Social Security Act for cost reporting peri- ods ending during fiscal year 1997.
p.000373: (B) DETERMINATION OF WAGE AND NON-WAGE-RELATED PROPORTION OF THE SINGLE PER RESIDENT AMOUNT.—The
p.000373: Secretary shall estimate the average proportion of the sin- gle per resident amounts computed under subparagraph
p.000373: (A) that is attributable to wages and wage-related costs.
p.000373: (C) STANDARDIZING PER RESIDENT AMOUNTS.—The Sec- retary shall establish a standardized per resident amount
p.000373: for each such hospital—
p.000373: (i) by dividing the single per resident amount com- puted under subparagraph (A) into a wage-related por- tion and a
p.000373: non-wage-related portion by applying the proportion determined under subparagraph (B);
p.000373: (ii) by dividing the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social
p.000373: Security Act for discharges occurring during fiscal year 1999 for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (D) DETERMINATION OF NATIONAL AVERAGE.—The Sec- retary shall compute a national average per resident
p.000373: amount equal to the average of the standardized per resi- dent amounts computed under subparagraph (C) for such
p.000373: hospitals, with the amount for each hospital weighted by the average number of full-time equivalent
p.000373: residents at such hospital.
p.000373: (E) APPLICATION TO INDIVIDUAL HOSPITALS.—The Sec- retary shall compute for each such hospital that is a
p.000373: chil- dren’s hospital a per resident amount—
p.000373: (i) by dividing the national average per resident amount computed under subparagraph (D) into a
p.000373: wage-related portion and a non-wage-related portion by applying the proportion determined under subpara- graph
p.000373: (B);
p.000373: (ii) by multiplying the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social Security
p.000373: Act for discharges occurring during the pre- ceding fiscal year for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (F) UPDATING RATE.—The Secretary shall update such per resident amount for each such children’s hospital by the
...

p.000385: (3) PRIMARY CARE RESIDENCY PROGRAM.—The term ‘‘pri- mary care residency program’’ has the meaning given
p.000385: that term in section 749A.
p.000385: (4) QUALIFIED TEACHING HEALTH CENTER.—The term ‘‘qualified teaching health center’’ has the
p.000385: meaning given the term ‘‘teaching health center’’ in section 749A.
p.000385:
p.000385: Subpart XII—Community-Based Collaborative Care Network Program
p.000385: SEC. 340I. ø256i¿ COMMUNITY-BASED COLLABORATIVE CARE NET-
p.000385: WORK PROGRAM. 55
p.000385: (a) IN GENERAL.—The Secretary may award grants to eligible entities to support community-based
p.000385: collaborative care networks that meet the requirements of subsection (b).
p.000385:
p.000385:
p.000385:
p.000385:
p.000385: January 30, 2020
p.000385: 55 Section 301(c) of Public Law 115–63 provides for amendments to part D of the Public Health Service Act by
p.000385: redesignating the second subpart XI and the second section 340H as subpart XII
p.000385: Continued
p.000385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000385:
p.000385:
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p.000385:
p.000385: Sec. 340I PUBLIC HEALTH SERVICE ACT 386
p.000385:
p.000385: (b) COMMUNITY-BASED COLLABORATIVE CARE NETWORKS.—
p.000385: (1) DESCRIPTION.—A community-based collaborative care network (referred to in this section as a
p.000385: ‘‘network’’) shall be a consortium of health care providers with a joint governance structure (including
p.000385: providers within a single entity) that pro- vides comprehensive coordinated and integrated health care services
p.000385: (as defined by the Secretary) for low-income popu- lations.
p.000385: (2) REQUIRED INCLUSION.—A network shall include the fol- lowing providers (unless such provider does not exist
p.000385: within the community, declines or refuses to participate, or places un- reasonable conditions on their participation):
p.000385: (A) A hospital that meets the criteria in section 1923(b)(1) of the Social Security Act; and
p.000385: (B) All Federally qualified health centers (as defined in section 1861(aa) of the Social Security Act located in
p.000385: the community.
p.000385: (3) PRIORITY.—In awarding grants, the Secretary shall give priority to networks that include—
p.000385: (A) the capability to provide the broadest range of services to low-income individuals;
p.000385: (B) the broadest range of providers that currently serve a high volume of low-income individuals; and
p.000385: (C) a county or municipal department of health.
p.000385: (c) APPLICATION.—
p.000385: (1) APPLICATION.—A network described in subsection (b) shall submit an application to the Secretary.
p.000385: (2) RENEWAL.—In subsequent years, based on the perform- ance of grantees, the Secretary may provide renewal grants to
p.000385: prior year grant recipients.
p.000385: (d) USE OF FUNDS.—
p.000385: (1) USE BY GRANTEES.—Grant funds may be used for the following activities:
p.000385: (A) Assist low-income individuals to—
p.000385: (i) access and appropriately use health services;
...

p.000389: standards as certified by an international standards organization recognized by the Secretary and meets the
p.000389: requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).
p.000389: (i) In this section:
p.000389: (1) The term ‘‘biological product’’ means a virus, thera- peutic serum, toxin, antitoxin, vaccine, blood, blood
p.000389: component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of
p.000389: arsphenamine (or any other trivalent organic arsenic compound), applicable to the preven- tion, treatment,
p.000389: or cure of a disease or condition of human beings.
p.000389: (2) The term ‘‘biosimilar’’ or ‘‘biosimilarity’’, in reference to a biological product that is the subject of an
p.000389: application under subsection (k), means—
p.000389: (A) that the biological product is highly similar to the reference product notwithstanding minor differences
p.000389: in clinically inactive components; and
p.000389: (B) there are no clinically meaningful differences be- tween the biological product and the reference
p.000389: product in terms of the safety, purity, and potency of the product.
p.000389: (3) The term ‘‘interchangeable’’ or ‘‘interchangeability’’, in reference to a biological product that is
p.000389: shown to meet the standards described in subsection (k)(4), means that the bio- logical product may be
p.000389: substituted for the reference product without the intervention of the health care provider who pre-
p.000389: scribed the reference product.
p.000389: (4) The term ‘‘reference product’’ means the single biologi- cal product licensed under subsection (a) against
p.000389: which a bio- logical product is evaluated in an application submitted under subsection (k).
p.000389: (j) The Federal Food, Drug, and Cosmetic Act, including the re- quirements under sections 505(o), 505(p), and
p.000389: 505–1 of such Act, applies to a biological product subject to regulation under this sec- tion, except that a
p.000389: product for which a license has been approved
p.000389:
p.000389:
p.000389:
p.000389:
p.000389:
p.000389: January 30, 2020
p.000389: 58 Codification remains chapter 9 of title 21, United States Code (§ 301 et seq.).
p.000389: 59 Section 2102(d)(2) of title II of Public Law 104–134 (110 Stat. 1321-319) amended certain provisions in
p.000389: subsection (h). Subsequently, section 2104 of such Public Law (110 Stat. 1321-320) amended subsection (h) in its
p.000389: entirety. The above reflects only the latter amendment.
p.000389: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000389:
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p.000389: Sec. 351 PUBLIC HEALTH SERVICE ACT 390
p.000389:
p.000389: under subsection (a) shall not be required to have an approved ap- plication under section 505 of such Act.
p.000389: (k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
p.000389: INTERCHANGEABLE.—
p.000389: (1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this
p.000389: subsection.
p.000389: (2) CONTENT.—
p.000389: (A) IN GENERAL.—
...

p.000461:
p.000461:
p.000461:
p.000461:
p.000461: January 30, 2020
p.000461: 86 Section 2(a)(2) of Public Law 114-104 amends subparagraph (B) by inserting ‘‘ including re- mote collection,’’ after
p.000461: ‘‘cord blood units,’’. Such amendment did not specify to which occurrence of the phrase ‘‘cord blood units,’’ to insert
p.000461: the new language.
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000461:
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p.000463: 463
p.000463: PUBLIC HEALTH SERVICE ACT
p.000463: Sec. 379
p.000463:
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p.000463: January 30, 2020
p.000463: the inventory goal. Each such plan shall be made available to the public.
p.000463: (C) DEFINITION.—In this paragraph, the term ‘‘remote collection’’ means the collection of cord blood units at
p.000463: loca- tions that do not have written contracts with cord blood banks for collection support.
p.000463: (3) SINGLE POINT OF ACCESS; STANDARD DATA.—
p.000463: (A) SINGLE POINT OF ACCESS.—The Secretary shall en- sure that health care professionals and patients are able
p.000463: to search electronically for and facilitate access to, in the manner and to the extent defined by the
p.000463: Secretary and consistent with the functions described in paragraphs (1)(A) and (2)(A)(i), cells from
p.000463: bone marrow donors and cord blood units through a single point of access.
p.000463: (B) STANDARD DATA.—The Secretary shall require all recipients of contracts under this section to make available a
p.000463: standard dataset for purposes of subparagraph (A) in a standardized electronic format that enables
p.000463: transplant physicians to compare among and between bone marrow donors and cord blood units to ensure the
p.000463: best possible match for the patient.
p.000463: (4) DEFINITION.—The term ‘‘qualified cord blood bank’’ means a cord blood bank that—
p.000463: (A) has obtained all applicable Federal and State li- censes, certifications, registrations (including
p.000463: pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate
p.000463: and maintain a cord blood bank;
p.000463: (B) has implemented donor screening, cord blood col- lection practices, and processing methods intended to
p.000463: pro- tect the health and safety of donors and transplant recipi- ents to improve transplant outcomes, including
p.000463: with re- spect to the transmission of potentially harmful infections and other diseases;
p.000463: (C) is accredited by an accreditation entity recognized by the Secretary under subsection (b);
p.000463: (D) has established a system of strict confidentiality to protect the identity and privacy of patients and
p.000463: donors in accordance with existing Federal and State law;
p.000463: (E) has established a system for encouraging donation by a genetically diverse group of donors; and
p.000463: (F) has established a system to confidentially maintain linkage between a cord blood unit and a maternal
p.000463: donor.
...

p.000477: pro- grams.
p.000477: (B) Programs designed for community-dwelling older adults that utilize multicomponent fall intervention ap-
p.000477: proaches, including physical activity, medication assess- ment and reduction when possible, vision
p.000477: enhancement, and home modification strategies.
p.000477: (C) Programs that are targeted to new fall victims who are at a high risk for second falls and which are designed to
p.000477: maximize independence and quality of life for older adults, particularly those older adults with functional
p.000477: limi- tations.
p.000477: (D) Private sector and public-private partnerships to develop technologies to prevent falls among older
p.000477: adults and prevent or reduce injuries if falls occur.
p.000477: (2)(A) Award grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia
p.000477: of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall
p.000477: prevention, to design, implement, and evaluate fall prevention programs using proven intervention strategies in
p.000477: residential and institutional settings.
p.000477: (B) Award 1 or more grants, contracts, or cooperative agreements to 1 or more qualified organizations,
p.000477: institutions, or consortia of qualified organizations and institutions, special- izing, or demonstrating expertise, in
p.000477: falls or fall prevention, in order to carry out a multistate demonstration project to imple- ment and evaluate
p.000477: fall prevention programs using proven intervention strategies designed for single and multifamily res- idential
p.000477: settings with high concentrations of older adults, in- cluding—
p.000477: (i) identifying high-risk populations;
p.000477: (ii) evaluating residential facilities;
p.000477: (iii) conducting screening to identify high-risk individ- uals;
p.000477: (iv) providing fall assessment and risk reduction inter- ventions and counseling;
p.000477: (v) coordinating services with health care and social service providers; and
p.000477: (vi) coordinating post-fall treatment and rehabilitation.
p.000477: (3) Award 1 or more grants, contracts, or cooperative agreements to qualified organizations,
p.000477: institutions, or consortia of qualified organizations and institutions, specializing, or demonstrating
p.000477: expertise, in falls or fall prevention, to conduct evaluations of the effectiveness of the demonstration
p.000477: projects described in this subsection.
p.000477: (d) PRIORITY.—In awarding grants, contracts, or cooperative agreements under this section, the Secretary
p.000477: may give priority to entities that explore the use of cost-sharing with respect to activi-
p.000477: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000477:
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p.000479: PUBLIC HEALTH SERVICE ACT
p.000479: Sec. 394A
p.000479:
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p.000609: tion 561(c) of the Federal Food, Drug, and Cosmetic Act; or
p.000609: (ii) as a Group C cancer drug (as defined by the Na- tional Cancer Institute).
p.000609: The data bank may also include information pertaining to the results of clinical trials of such treatments, with the
p.000609: consent of the sponsor, including information concerning potential toxicities or adverse effects
p.000609: associated with the use or adminis- tration of such experimental treatments.
p.000609:
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p.000609:
p.000609: January 30, 2020
p.000609: 4 Section 15(c)(2) of Public Law 107–109 (115 Stat. 1420) attempted to make amendments to the first
p.000609: sentence of subparagraph (A), but the amendments cannot be executed because the terms to be amended appear
p.000609: in the second sentence, not the first. The following shows the sec- ond sentence as it would appear if the amendments
p.000609: were executed to the second sentence: ‘‘In- formation provided shall consist of eligibility criteria for participation
p.000609: in the clinical trials, a de- scription of the location of trial sites, a point of contact for those wanting to enroll
p.000609: in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the
p.000609: investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards,
p.000609: for single-patient and expanded protocol use of the new drug, particularly in chil- dren, and shall be in a
p.000609: form that can be readily understood by members of the public.’’.
p.000609: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000609:
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p.000609:
p.000611: 611
p.000611: PUBLIC HEALTH SERVICE ACT
p.000611: Sec. 402
p.000611:
p.000611: (4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed
p.000611: certification to the Secretary that disclosure of such information would substan- tially interfere with the
p.000611: timely enrollment of subjects in the inves- tigation, unless the Secretary, after the receipt of the certification,
p.000611: provides the sponsor with a detailed written determination that such disclosure would not substantially
p.000611: interfere with such enroll- ment.
p.000611: (5) Fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act shall not be used in carrying out this
p.000611: subsection.
p.000611: (j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.—
p.000611: (1) DEFINITIONS; REQUIREMENT.—
p.000611: (A) DEFINITIONS.—In this subsection:
p.000611: (i) APPLICABLE CLINICAL TRIAL.—The term ‘‘appli- cable clinical trial’’ means an applicable device clinical trial
p.000611: or an applicable drug clinical trial.
...

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p.000641: lishing, improving, and providing basic operating support for centers of excellence regarding research on
p.000641: various forms of muscular dystrophy. Such centers of excellence shall be known as the ‘‘Paul D. Wellstone Muscular
p.000641: Dystrophy Cooperative Re- search Centers’’.
p.000641: (2) RESEARCH.—Each center under paragraph (1) shall supplement but not replace the establishment of a
p.000641: comprehen- sive research portfolio in all the muscular dystrophies. As a whole, the centers shall conduct
p.000641: basic and clinical research in all forms of muscular dystrophy including early detection, diag- nosis, prevention,
p.000641: and treatment, including the fields of muscle biology, genetics, noninvasive imaging, cardiac and pulmonary
p.000641: function, and pharmacological and other therapies.
p.000641: (3) COORDINATION OF CENTERS.—The Director of NIH shall, as appropriate, provide for the coordination
p.000641: of informa- tion among centers under paragraph (1) and ensure regular communication and sharing of data
p.000641: between such centers.
p.000641: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000641: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may
p.000641: be prescribed by the Director of NIH.
p.000641: (5) DURATION OF SUPPORT.—Support for a center estab- lished under paragraph (1) may be provided under this
p.000641: section for a period of not to exceed 5 years. Such period may be ex- tended for 1 or more additional
p.000641: periods not exceeding 5 years if the operations of such center have been reviewed by an ap- propriate
p.000641: technical and scientific peer review group established by the Director of NIH and if such group has recommended to the
p.000641: Director that such period should be extended.
p.000641: (c) FACILITATION OF RESEARCH.—The Director of NIH shall provide for a program under subsection (a)(1) under
p.000641: which samples of tissues and genetic materials that are of use in research on mus- cular dystrophy are donated,
p.000641: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000641: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000641: samples.
p.000641: (d) COORDINATING COMMITTEE.—
p.000641: (1) IN GENERAL.—The Secretary shall establish the Mus- cular Dystrophy Coordinating Committee (referred to
p.000641: in this section as the ‘‘Coordinating Committee’’) to coordinate activi- ties across the National
p.000641: Institutes and with other Federal health programs and activities relating to the various forms of muscular
p.000641: dystrophy.
p.000641: (2) COMPOSITION.—The Coordinating Committee shall con- sist of not more than 18 members to be appointed by the Sec-
p.000641: retary, of which—
...

p.000663:
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p.000665: PUBLIC HEALTH SERVICE ACT
p.000665: Sec. 409B
p.000665:
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p.000665: January 30, 2020
p.000665: less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee
p.000665: on Appropriations and the Committee on Labor and Human Resources of the Sen- ate and the Committee on
p.000665: Appropriations and the Committee on Commerce of the House of Representatives a report con- cerning the
p.000665: conference.
p.000665: (c) MORRIS K. UDALL RESEARCH CENTERS.—
p.000665: (1) IN GENERAL.—The Director of NIH is authorized to award Core Center Grants to encourage the development of
p.000665: in- novative multidisciplinary research and provide training con- cerning Parkinson’s disease. The
p.000665: Director is authorized to award not more than 10 Core Center Grants and designate each center funded
p.000665: under such grants as a Morris K. Udall Center for Research on Parkinson’s Disease.
p.000665: (2) REQUIREMENTS.—
p.000665: (A) IN GENERAL.—With respect to Parkinson’s disease, each center assisted under this subsection shall—
p.000665: (i) use the facilities of a single institution or a con- sortium of cooperating institutions, and meet such
p.000665: qualifications as may be prescribed by the Director of the NIH; and
p.000665: (ii) conduct basic and clinical research.
p.000665: (B) DISCRETIONARY REQUIREMENTS.—With respect to Parkinson’s disease, each center assisted under this sub-
p.000665: section may—
p.000665: (i) conduct training programs for scientists and health professionals;
p.000665: (ii) conduct programs to provide information and continuing education to health professionals;
p.000665: (iii) conduct programs for the dissemination of in- formation to the public;
p.000665: (iv) separately or in collaboration with other cen- ters, establish a nationwide data system derived from
p.000665: patient populations with Parkinson’s disease, and where possible, comparing relevant data involving
p.000665: general populations;
p.000665: (v) separately or in collaboration with other cen- ters, establish a Parkinson’s Disease Information
p.000665: Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson’s disease; and
p.000665: (vi) separately or in collaboration with other cen- ters, establish a national education program that
p.000665: fos- ters a national focus on Parkinson’s disease and the care of those with Parkinson’s disease.
p.000665: (3) STIPENDS REGARDING TRAINING PROGRAMS.—A center may use funds provided under paragraph (1) to
p.000665: provide sti- pends for scientists and health professionals enrolled in train- ing programs under paragraph
p.000665: (2)(B).
...

p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000667: samples.
p.000667: (d) PUBLIC INPUT.—The Director shall under subsection (a)(1) provide for means through which the public can
p.000667: obtain information
p.000667: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000667:
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p.000711: may hold such meetings as are necessary to enable them to carry out their activities.
p.000711: (j) The National Diabetes Advisory Board and the National Di- gestive Diseases Advisory Board in existence on the date
p.000711: of enact- ment of the Health Research Extension Act of 1985 shall terminate upon the appointment of a successor
p.000711: Board under subsection (a). The Secretary shall make appointments to the Advisory Boards es- tablished under
p.000711: subsection (a) before the expiration of 90 days after such date. The members of the Boards in existence on
p.000711: such date may be appointed, in accordance with subsections (b) and (d), to the Boards established under
p.000711: subsection (a) for diabetes and diges- tive diseases, except that at least one-half of the members of the
p.000711: National Diabetes Advisory Board in existence on the date of enact- ment of the Health Research Extension Act of
p.000711: 1985 shall be ap- pointed to the National Diabetes Advisory Board first established under subsection (a).
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p.000711: January 30, 2020
p.000711: RESEARCH AND TRAINING CENTERS
p.000711: SEC. 431. ø285c–5¿ (a)(1) Consistent with applicable rec- ommendations of the National Commission on
p.000711: Diabetes, the Direc- tor of the Institute shall provide for the development or substantial expansion of centers for
p.000711: research and training in diabetes mellitus and related endocrine and metabolic diseases. Each center devel-
p.000711: oped or expanded under this subsection shall—
p.000711: (A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting
p.000711: such re- search and training qualifications as may be prescribed by the Secretary; and
p.000711: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000711:
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p.000711: Sec. 431 PUBLIC HEALTH SERVICE ACT 712
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p.000711: January 30, 2020
p.000711:
p.000711: (B) conduct—
p.000711: (i) research in the diagnosis and treatment of diabetes mellitus and related endocrine and metabolic diseases and the
p.000711: complications resulting from such diseases;
p.000711: (ii) training programs for physicians and allied health personnel in current methods of diagnosis and treatment
p.000711: of such diseases and complications, and in research in dia- betes; and
p.000711: (iii) information programs for physicians and allied health personnel who provide primary care for
p.000711: patients with such diseases or complications.
p.000711: (2) A center may use funds provided under paragraph (1) to provide stipends for nurses and allied health
p.000711: professionals enrolled in research training programs described in paragraph (1)(B)(ii).
p.000711: (b) Consistent with applicable recommendations of the Na- tional Digestive Diseases Advisory Board, the
p.000711: Director shall pro- vide for the development or substantial expansion of centers for re- search in digestive diseases
p.000711: and related functional, congenital, met- abolic disorders, and normal development of the digestive tract. Each
p.000711: center developed or expanded under this subsection—
p.000711: (1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating
p.000711: institutions, meeting such research qualifications as may be prescribed by the Sec- retary;
p.000711: (2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection,
p.000711: prevention, control, and treatment of digestive diseases and nutritional disorders and related functional,
p.000711: congenital, or metabolic complications resulting from such diseases or disorders;
p.000711: (3) shall encourage research into and programs for—
p.000711: (A) providing information for patients with such dis- eases and the families of such patients, physicians
p.000711: and others who care for such patients, and the general public;
p.000711: (B) model programs for cost effective and preventive patient care; and
p.000711: (C) training physicians and scientists in research on such diseases, disorders, and complications; and
p.000711: (4) may perform research and participate in epidemiolog- ical studies and data collection relevant to
p.000711: digestive diseases and disorders and disseminate such research, studies, and data to the health care profession and to
p.000711: the public.
p.000711: (c) The Director shall provide for the development or substan- tial expansion of centers for research in
p.000711: kidney and urologic dis- eases. Each center developed or expanded under this subsection—
p.000711: (1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating
p.000711: institutions, meeting such research qualifications as may be prescribed by the Sec- retary;
p.000711: (2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection,
p.000711: prevention, control, and treatment of kidney and urologic diseases;
p.000711: (3) shall encourage research into and programs for—
p.000711: (A) providing information for patients with such dis- eases, disorders, and complications and the families
p.000711: of
p.000711: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000713: 713
p.000713: PUBLIC HEALTH SERVICE ACT
p.000713: Sec. 432
p.000713:
p.000713: such patients, physicians and others who care for such pa- tients, and the general public;
p.000713: (B) model programs for cost effective and preventive patient care; and
p.000713: (C) training physicians and scientists in research on such diseases; and
p.000713: (4) may perform research and participate in epidemiolog- ical studies and data collection relevant to kidney and
p.000713: urologic diseases in order to disseminate such research, studies, and data to the health care profession and to
p.000713: the public.
p.000713: (d)(1) The Director of the Institute shall, subject to the extent of amounts made available in
p.000713: appropriations Acts, provide for the development or substantial expansion of centers for research and
p.000713: training regarding nutritional disorders, including obesity.
p.000713: (2) The Director of the Institute shall carry out paragraph (1) in collaboration with the Director of the
p.000713: National Cancer Institute and with the Directors of such other agencies of the National Insti- tutes of Health as
p.000713: the Director of NIH determines to be appro- priate.
p.000713: (3) Each center developed or expanded under paragraph (1) shall—
p.000713: (A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting
p.000713: such re- search and training qualifications as may be prescribed by the Director;
p.000713: (B) conduct basic and clinical research into the cause, diag- nosis, early detection, prevention, control and treatment
p.000713: of nu- tritional disorders, including obesity and the impact of nutri- tion and diet on child development;
p.000713: (C) conduct training programs for physicians and allied health professionals in current methods of diagnosis and
p.000713: treat- ment of such diseases and complications, and in research in such disorders; and
p.000713: (D) conduct information programs for physicians and allied health professionals who provide primary care for
p.000713: patients with such disorders or complications.
p.000713: (e) Insofar as practicable, centers developed or expanded under this section should be geographically dispersed
p.000713: throughout the United States and in environments with proven research capabili- ties. Support of a center
p.000713: under this section may be for a period of not to exceed five years and such period may be extended
p.000713: by the Director of the Institute for additional periods of not more than five years each if the operations of
p.000713: such center have been reviewed by an appropriate technical and scientific peer review group estab- lished
p.000713: by the Director and if such group has recommended to the Director that such period should be extended.
p.000713:
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p.000713: January 30, 2020
p.000713:
p.000713: ADVISORY COUNCIL SUBCOMMITTEES
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p.000717: diseases, in- cluding investigations into the social, environmental, behav- ioral, nutritional, and genetic
p.000717: determinants and influences in- volved in the epidemiology of arthritis and musculoskeletal dis- eases.
p.000717: (c) The Director shall provide for the standardization of patient data and recordkeeping for the collection,
p.000717: storage, analysis, re- trieval, and dissemination of such data in cooperation with projects assisted under this
p.000717: section, centers assisted under section 441, and other persons engaged in arthritis and musculoskeletal disease pro-
p.000717: grams.
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p.000717: January 30, 2020
p.000717: MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS
p.000717: SEC. 441. ø285d–6¿ (a) The Director of the Institute shall, after consultation with the advisory council for the
p.000717: Institute, provide for the development, modernization, and operation (including staffing and other operating
p.000717: costs such as the costs of patient care required for research) of new and existing centers for arthritis and musculo-
p.000717: skeletal diseases. For purposes of this section, the term ‘‘mod- ernization’’ means the alteration,
p.000717: remodeling, improvement, expan- sion, and repair of existing buildings and the provision of equip- ment for
p.000717: such buildings to the extent necessary to make them suit- able for use as centers described in the preceding sentence.
p.000717: (b) Each center assisted under this section shall—
p.000717: (1)(A) use the facilities of a single institution or a consor- tium of cooperating institutions, and (B)
p.000717: meet such qualifica- tions as may be prescribed by the Secretary; and
p.000717: (2) conduct—
p.000717: (A) basic and clinical research into the cause, diag- nosis, early detection, prevention, control, and
p.000717: treatment of and rehabilitation from arthritis and musculoskeletal dis- eases and complications resulting
p.000717: from arthritis and mus-
p.000717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000717:
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p.000719: 719
p.000719: PUBLIC HEALTH SERVICE ACT
p.000719: Sec. 441
p.000719:
p.000719: culoskeletal diseases, including research into implantable biomaterials and biomechanical and other
p.000719: orthopedic pro- cedures;
p.000719: (B) training programs for physicians, scientists, and other health and allied health professionals;
p.000719: (C) information and continuing education programs for physicians and other health and allied health professionals who
p.000719: provide care for patients with arthritis and musculo- skeletal diseases; and
p.000719: (D) programs for the dissemination to the general pub- lic of information—
p.000719: (i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treat- ment, and
p.000719: of following an appropriate regimen; and
p.000719: (ii) to discourage the promotion and use of unap- proved and ineffective diagnostic, preventive, treat-
...

p.000723: National Research Service Awards 26 may be provided under section 487.
p.000723: (c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be
p.000723: extended by the Di- rector for additional periods of not more than five years each if the operations of such center
p.000723: have been reviewed by an appropriate technical and scientific peer review group established by the Direc- tor and
p.000723: if such group has recommended to the Director that such period should be extended.
p.000723:
p.000723:
p.000723:
p.000723:
p.000723: January 30, 2020
p.000723: 26 Now Ruth L. Kirschstein National Research Service Awards. See section 487.
p.000723: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000723:
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p.000723: Sec. 445A PUBLIC HEALTH SERVICE ACT 724
p.000723:
p.000723: CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
p.000723: SEC. 445A. ø285e–3¿ (a) The Director of the Institute shall enter into cooperative agreements with, and make
p.000723: grants to, public and private nonprofit entities for the development or expansion of not less than 10
p.000723: centers of excellence in geriatric research and training of researchers. Each such center shall be known
p.000723: as a Claude D. Pepper Older Americans Independence Center.
p.000723: (b) Each center developed or expanded under this section shall—
p.000723: (1) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting
p.000723: such re- search and training qualifications as may be prescribed by the Director; and
p.000723: (2) conduct—
p.000723: (A) research into the aging processes and into the di- agnosis and treatment of diseases, disorders, and
p.000723: complica- tions related to aging, including menopause, which re- search includes research on such treatments,
p.000723: and on med- ical devices and other medical interventions regarding such diseases, disorders, and
p.000723: complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in
p.000723: otherwise increasing the independ- ence of the individuals; and
p.000723: (B) programs to develop individuals capable of con- ducting research described in subparagraph (A).
p.000723: (c) In making cooperative agreements and grants under this section for the development or expansion of centers,
p.000723: the Director of the Institute shall ensure that, to the extent practicable, any such centers are distributed
p.000723: equitably among the principal geographic regions of the United States.
p.000723: (d) For purposes of this section, the term ‘‘independence’’, with respect to diseases, disorders, and
p.000723: complications of aging, means the functional ability of individuals to perform activities of daily living
p.000723: or instrumental activities of daily living without assistance or supervision.
p.000723: AWARDS AUTHORIZED
p.000723: SEC. 445B. 27 ø285e–4¿ (a) The Director of the Institute shall make awards to senior researchers who
p.000723: have made distinguished achievements in biomedical research in areas relating to Alz- heimer’s
...

p.000727: available under this section shall be directed to the support of promising clinicians through awards for
p.000727: research, study, and practice at centers of excellence in Alzheimer’s disease research and treatment.
p.000727: (c) EXCELLENCE IN CERTAIN FIELDS.—Research shall be carried out under awards made under subsection (b) in
p.000727: environments of demonstrated excellence in neuroscience, neurobiology, geriatric medicine, and psychiatry and
p.000727: shall foster innovation and integra- tion of such disciplines or other environments determined suitable by
p.000727: the Director of the Institute.
p.000727: Subpart 6—National Institute of Allergy and Infectious Diseases
p.000727: PURPOSE OF THE INSTITUTE
p.000727: SEC. 446. ø285f¿ The general purpose of the National Institute of Allergy and Infectious Diseases is the conduct and
p.000727: support of re- search, training, health information dissemination, and other pro- grams with respect to
p.000727: allergic and immunologic diseases and dis- orders and infectious diseases, including tropical diseases.
p.000727:
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p.000727:
p.000727: January 30, 2020
p.000727: RESEARCH CENTERS REGARDING CHRONIC FATIGUE SYNDROME
p.000727: SEC. 447. ø285f–1¿ (a) The Director of the Institute, after con- sultation with the advisory council for the
p.000727: Institute, may make grants to, or enter into contracts with, public or nonprofit private entities for the
p.000727: development and operation of centers to conduct basic and clinical research on chronic fatigue syndrome.
p.000727: (b) Each center assisted under this section shall use the facili- ties of a single institution, or be formed
p.000727: from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000727: Director of the Institute.
p.000727: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000727:
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p.000727:
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p.000729: 729
p.000729: PUBLIC HEALTH SERVICE ACT
p.000729: Sec. 448
p.000729:
p.000729: RESEARCH AND RESEARCH TRAINING REGARDING TUBERCULOSIS
p.000729: SEC. 447A. ø285f–2¿ In carrying out section 446, the Director of the Institute shall conduct or support
p.000729: research and research training regarding the cause, diagnosis, early detection, prevention and treatment of
p.000729: tuberculosis.
p.000729: SEC. 447B. ø285f–3¿ SEXUALLY TRANSMITTED DISEASE CLINICAL RE- SEARCH AND TRAINING AWARDS.
p.000729: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
p.000729: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000729: treatment of individuals with sexually transmitted diseases.
p.000729: (b) SUPPORT OF PROMISING CLINICIANS.—In order to foster the application of the most current developments in the
p.000729: etiology, patho- genesis, diagnosis, prevention and treatment of sexually trans- mitted diseases, amounts
p.000729: made available under this section shall be directed to the support of promising clinicians through awards
...

p.000733:
p.000733:
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p.000733:
p.000733: Sec. 452B PUBLIC HEALTH SERVICE ACT 734
p.000733:
p.000733: (i) for centers with respect to contraception, clinical trials of new or improved drugs and devices for
p.000733: use by males and females (including barrier methods); and
p.000733: (ii) for centers with respect to infertility, clinical trials of new or improved drugs and devices for the
p.000733: diagnosis and treatment of infertility in males and females;
p.000733: (B) develop protocols for training physicians, scientists, nurses, and other health and allied health
p.000733: professionals;
p.000733: (C) conduct training programs for such individuals;
p.000733: (D) develop model continuing education programs for such professionals; and
p.000733: (E) disseminate information to such professionals and the public.
p.000733: (2) A center may use funds provided under subsection (a) to provide stipends for health and allied health
p.000733: professionals enrolled in programs described in subparagraph (C) of paragraph (1), and to provide fees to
p.000733: individuals serving as subjects in clinical trials conducted under such paragraph.
p.000733: (d) The Director of the Institute shall, as appropriate, provide for the coordination of information
p.000733: among the centers assisted under this section.
p.000733: (e) Each center assisted under subsection (a) shall use the fa- cilities of a single institution, or be
p.000733: formed from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000733: Director of the Institute.
p.000733: (f) Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be
p.000733: extended for one or more additional periods not exceeding 5 years if the operations of such center have
p.000733: been reviewed by an appropriate technical and scientific peer review group established by the Director and if
p.000733: such group has recommended to the Director that such period should be extended.
p.000733:
p.000733: PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
p.000733: SEC. 452B. ø285g–6¿ The Director of the Institute shall estab- lish and maintain within the Institute an
p.000733: intramural laboratory and clinical research program in obstetrics and gynecology.
p.000733: CHILD HEALTH RESEARCH CENTERS
p.000733: SEC. 452C. ø285g–7¿ The Director of the Institute shall de- velop and support centers for conducting
p.000733: research with respect to child health. Such centers shall give priority to the expeditious transfer of
p.000733: advances from basic science to clinical applications and improving the care of infants and children.
p.000733:
p.000733:
p.000733:
p.000733:
p.000733:
p.000733:
p.000733:
p.000733:
p.000733:
p.000733: January 30, 2020
p.000733:
p.000733: PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH
p.000733: SEC. 452D. ø285g–8¿ (a) IN GENERAL.—Not later than October 1, 1993, the Director of the Institute shall
...

p.000735: (A) IN GENERAL.—In carrying out paragraph (1), the Director of the Institute shall, to the extent that
p.000735: amounts are appropriated, and subject to subparagraph (B), provide for the establishment of at least three
p.000735: fragile X research centers.
p.000735: (B) PEER REVIEW REQUIREMENT.—The Director of the Institute shall make a grant to, or enter into a
p.000735: contract with, an entity for purposes of establishing a center under paragraph (1) only if the grant or contract
p.000735: has been rec- ommended after technical and scientific peer review re- quired by regulations under section
p.000735: 492.
p.000735: (3) ACTIVITIES.—The Director of the Institute, with the as- sistance of centers established under paragraph (1),
p.000735: shall con-
p.000735: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000735:
p.000735:
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p.000735:
p.000735: Sec. 452G PUBLIC HEALTH SERVICE ACT 736
p.000735:
p.000735: duct and support basic and biomedical research into the detec- tion and treatment of fragile X.
p.000735: (4) COORDINATION AMONG CENTERS.—The Director of the Institute shall, as appropriate, provide for the
p.000735: coordination of the activities of the centers assisted under this section, includ- ing providing for the exchange
p.000735: of information among the cen- ters.
p.000735: (5) CERTAIN ADMINISTRATIVE REQUIREMENTS.—Each center assisted under paragraph (1) shall use the facilities of a
p.000735: single institution, or be formed from a consortium of cooperating in- stitutions, meeting such requirements as
p.000735: may be prescribed by the Director of the Institute.
p.000735: (6) DURATION OF SUPPORT.—Support may be provided to a center under paragraph (1) for a period not exceeding 5 years.
p.000735: Such period may be extended for one or more additional peri- ods, each of which may not exceed 5
p.000735: years, if the operations of such center have been reviewed by an appropriate technical and scientific peer review
p.000735: group established by the Director and if such group has recommended to the Director that such period be
p.000735: extended.
p.000735: INVESTMENT IN TOMORROW’S PEDIATRIC RESEARCHERS
p.000735: SEC. 452G. 35 ø285g–10¿ In order to ensure the future supply of researchers dedicated to the care and research
p.000735: needs of children, the Director of the Institute, after consultation with the Adminis- trator of the Health
p.000735: Resources and Services Administration, shall support activities to provide for—
p.000735: (1) an increase in the number and size of institutional training grants to institutions supporting
p.000735: pediatric training; and
p.000735: (2) an increase in the number of career development awards for health professionals who intend to build
p.000735: careers in pediatric basic and clinical research, including pediatric phar- macological research.
p.000735: Subpart 8—National Institute of Dental Research 36
p.000735: PURPOSE OF THE INSTITUTE
p.000735: SEC. 453. ø285h¿ The general purpose of the National Institute of Dental Research 36 is the conduct and support of
p.000735: research, train- ing, health information dissemination, and other programs with re- spect to the cause, prevention, and
...

p.000741: knowledge and understanding of disorders of hearing and other communication processes by health
p.000741: profes- sionals, patients, industry, and the public.
p.000741:
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p.000741:
p.000741: January 30, 2020
p.000741: MULTIPURPOSE DEAFNESS AND OTHER COMMUNICATION DISORDERS CENTER
p.000741: SEC. 464C. ø285m–3¿ (a) The Director of the Institute shall, after consultation with the advisory council
p.000741: for the Institute, pro- vide for the development, modernization, and operation (including care required
p.000741: for research) of new and existing centers for studies of disorders of hearing and other communication
p.000741: processes. For purposes of this section, the term ‘‘modernization’’ means the alter- ation, remodeling, improvement,
p.000741: expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent
p.000741: necessary to make them suitable for use as centers de- scribed in the preceding sentence.
p.000741: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000741:
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p.000741:
p.000741: Sec. 464C PUBLIC HEALTH SERVICE ACT 742
p.000741:
p.000741: (b) Each center assisted under this section shall—
p.000741: (1) use the facilities of a single institution or a consortium of cooperating institutions; and
p.000741: (2) meet such qualifications as may be prescribed by the Secretary.
p.000741: (c) Each center assisted under this section shall, at least, con- duct—
p.000741: (1) basic and clinical research into the cause diagnosis, early detection, prevention, control and
p.000741: treatment of disorders of hearing and other communication processes and complica- tions resulting from such
p.000741: disorders, including research into re- habilitative aids, implantable biomaterials, auditory speech
p.000741: processors, speech production devices, and other otolaryngologic procedures;
p.000741: (2) training programs for physicians, scientists, and other health and allied health professionals;
p.000741: (3) information and continuing education programs for physicians and other health and allied health
p.000741: professionals who will provide care for patients with disorders of hearing or other communication processes; and
p.000741: (4) programs for the dissemination to the general public of information—
p.000741: (A) on the importance of early detection of disorders of hearing and other communication processes, of seeking
p.000741: prompt treatment, rehabilitation, and of following an ap- propriate regimen; and
p.000741: (B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect
p.000741: dis- orders of hearing or other communication processes.
p.000741: (d) A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000741: enrolled in training pro- grams described in subsection (c)(2).
p.000741: (e) Each center assisted under this section may conduct pro- grams—
p.000741:
...

p.000771: SEC. 476. ø286b–7¿ (a) The Secretary, with the advice of the Board, shall make grants to, and enter
p.000771: into appropriate contracts with, public or private nonprofit institutions of higher education
p.000771: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000771:
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p.000771:
p.000771: Sec. 477 PUBLIC HEALTH SERVICE ACT 772
p.000771:
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p.000771:
p.000771:
p.000771: January 30, 2020
p.000771:
p.000771: and individual scientists for the purpose of supporting biomedical scientific publications of a nonprofit
p.000771: nature and to procure the com- pilation, writing, editing, and publication of reviews, abstracts, in- dices,
p.000771: handbooks, bibliographies, and related matter pertaining to scientific works and scientific developments.
p.000771: (b) Grants under subsection (a) in support of any single peri- odical publication may not be made for more
p.000771: than three years, ex- cept in those cases in which the Secretary determines that further support is necessary to carry
p.000771: out the purposes of subsection (a).
p.000771: GRANT PAYMENTS, RECORDS, AND AUDIT
p.000771: SEC. 477. ø286b–8¿ (a) Payments under grants made under sections 472, 473, 474, 475, and 476 may be
p.000771: made in advance or by way of reimbursement and in such installments as the Secretary shall prescribe by regulation
p.000771: after consultation with the Board.
p.000771: (b)(1) Each recipient of a grant under this subpart shall keep such records as the Secretary shall
p.000771: prescribe, including records which fully disclose the amount and disposition by such recipient of the
p.000771: proceeds of such grant, the total cost of the project or under- taking in connection with which such grant is
p.000771: given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources,
p.000771: and such other records as will facilitate an effective audit.
p.000771: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000771: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000771: records of such recipients that are pertinent to any grant received under this subpart.
p.000771: Subpart 3—National Center for Biotechnology Information
p.000771: PURPOSE, ESTABLISHMENT, FUNCTIONS, AND FUNDING OF THE NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION
p.000771: SEC. 478. ø286c¿ (a) In order to focus and expand the collec- tion, storage, retrieval, and
...

p.000803: (2) APPLICABILITY.—For fiscal year 1995 and subsequent fiscal years, the Director of NIH may not approve any
p.000803: proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health
p.000803: unless the proposal speci- fies the manner in which the research will comply with this section.
p.000803: (f) REPORTS BY ADVISORY COUNCILS.—
p.000803: (1) IN GENERAL.—The advisory council of each national re- search institute shall prepare triennial reports
p.000803: describing the manner in which the institute has complied with this section. Each such report shall be
p.000803: submitted to the Director of the in- stitute involved for inclusion in the triennial report under sec- tion 403.
p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000803:
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p.000805: 805
p.000805: PUBLIC HEALTH SERVICE ACT
p.000805: Sec. 493
p.000805:
p.000805: (2) CONTENTS.—Each triennial report prepared by an advi- sory council of each national research institute as described
p.000805: in paragraph (1) shall include each of the following:
p.000805: (A) The number of women included as subjects, and the proportion of subjects that are women, in any
p.000805: project of clinical research conducted during the applicable report- ing period, disaggregated by categories of
p.000805: research area, condition, or disease, and accounting for single-sex studies.
p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
p.000805:
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p.000805:
p.000805: January 30, 2020
p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
p.000805: (1) ESTABLISHMENT OF OFFICE.—Not later than 90 days after the date of enactment of this section, the Secretary
p.000805: shall establish an office to be known as the Office of Research Integ- rity (referred to in this section as the
...

p.000925: populations; and
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p.000925: January 30, 2020
p.000925: (5) other topic areas that are relevant to the objectives de- scribed in subsection (a).
p.000925: (d) GEOGRAPHIC DISTRIBUTION.—In awarding cooperative agreements under subsection (a), the Secretary
p.000925: shall take into ac- count regional differences among eligible entities and shall make an effort to ensure
p.000925: geographic distribution.
p.000925: (e) EVALUATION.—The Secretary shall evaluate each project carried out by an entity receiving an award under this
p.000925: section and shall disseminate the findings with respect to each such evaluation to appropriate public and private
p.000925: entities.
p.000925: (f) FUNDING.—There is authorized to be appropriated to carry out this section, $4,000,000 for each of
p.000925: fiscal years 2019 through 2023.
p.000925: SEC. 552. ø290ee–7¿ COMPREHENSIVE OPIOID RECOVERY CENTERS.
p.000925: (a) IN GENERAL.—The Secretary shall award grants on a com- petitive basis to eligible entities to establish or
p.000925: operate a com- prehensive opioid recovery center (referred to in this section as a ‘‘Center’’). A Center
p.000925: may be a single entity or an integrated deliv- ery network.
p.000925: (b) GRANT PERIOD.—
p.000925: (1) IN GENERAL.—A grant awarded under subsection (a) shall be for a period of not less than 3 years and not more
p.000925: than 5 years.
p.000925: (2) RENEWAL.—A grant awarded under subsection (a) may be renewed, on a competitive basis, for additional
p.000925: periods of time, as determined by the Secretary. In determining whether to renew a grant under this paragraph,
p.000925: the Secretary shall consider the data submitted under subsection (h).
p.000925: (c) MINIMUM NUMBER OF CENTERS.—The Secretary shall allo- cate the amounts made available under subsection (j)
p.000925: such that not fewer than 10 grants may be awarded. Not more than one grant shall be made to entities in a
p.000925: single State for any one period.
p.000925: (d) APPLICATION.—
p.000925: (1) ELIGIBLE ENTITY.—An entity is eligible for a grant under this section if the entity offers treatment and
p.000925: other serv- ices for individuals with a substance use disorder.
p.000925: (2) SUBMISSION OF APPLICATION.—In order to be eligible for a grant under subsection (a), an entity shall
p.000925: submit an applica- tion to the Secretary at such time and in such manner as the Secretary may require. Such
p.000925: application shall include—
p.000925: (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activi-
p.000925: ties described in subsection (g); and
p.000925: (B) such other information as the Secretary may re- quire.
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000925:
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p.000927: 927
p.000927: PUBLIC HEALTH SERVICE ACT
p.000927: Sec. 552
p.000927:
p.000927: (e) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to eligible entities—
p.000927: (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national
p.000927: overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or
...

p.000955: other facilities for which aid under this part is available, and for developing plans for the distribution of such
p.000955: beds and facilities;
p.000955: (d) criteria for determining the extent to which existing facili- ties, for which aid under this part is
p.000955: available, are in need of mod- ernization; and
p.000955: (e) that the State plan shall provide for adequate hospitals, and other facilities for which aid under
p.000955: this part is available, for all persons residing in the State, and adequate hospitals (and such other facilities)
p.000955: to furnish needed services for persons unable to pay therefor. Such regulations may also require that before approval
p.000955: of an application for a project is recommended by a State agency to the Surgeon General for approval
p.000955: under this part, assurance shall be received by the State from the applicant that (1) the facility or
p.000955: portion thereof to be constructed or modernized will be made avail- able to all persons residing in the territorial
p.000955: area of the applicant; and (2) there will be made available in the facility or portion there- of to be constructed or
p.000955: modernized a reasonable volume of services to persons unable to pay therefor, but an exception shall be made
p.000955: if such a requirement is not feasible from a financial viewpoint.
p.000955:
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p.000955: January 30, 2020
p.000955:
p.000955: STATE PLANS
p.000955: SEC. 604. ø291d¿ (a) Any State desiring to participate in this part may submit a State plan. Such plan must—
p.000955: (1) designate a single State agency as the sole agency for the administration of the plan, or designate such
p.000955: agency as the sole agency for supervising the administration of the plan;
p.000955: (2) contain satisfactory evidence that the State agency des- ignated in accordance with paragraph (1) will have
p.000955: authority to carry out such plan in conformity with this part;
p.000955: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000957: 957
p.000957: PUBLIC HEALTH SERVICE ACT
p.000957: Sec. 604
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p.000957: January 30, 2020
p.000957: (3) provide for the designation of a State advisory council which shall include (A) representatives of
p.000957: nongovernmental or- ganizations or groups, and of public agencies, concerned with the operation,
p.000957: construction, or utilization of hospital or other facilities for diagnosis, prevention, or treatment of
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p.000983: January 30, 2020
p.000983:
p.000983: tion 702, the Secretary may, in accordance with regulations, make commitments to insure such future loans
p.000983: or payments, and such commitments may be honored either as provided in subsection (a) or by inclusion of
p.000983: such insurance in comprehen- sive coverage under this subsection for the period or periods in which such future loans
p.000983: or payments are made.
p.000983: (c) ASSIGNMENT OF INSURANCE RIGHTS.—The rights of an eligi- ble lender arising under insurance evidenced by a
p.000983: certificate of in- surance issued to it under this section may be assigned by such lender, subject to
p.000983: regulation by the Secretary, only to—
p.000983: (1) another eligible lender (including a public entity in the business of purchasing student loans); or
p.000983: (2) the Student Loan Marketing Association.
p.000983: (d) EFFECT OF REFINANCING OR CONSOLIDATION OF OBLIGA- TIONS.—The consolidation of the obligations of
p.000983: two or more feder- ally insured loans obtained by a borrower in any fiscal year into a single
p.000983: obligation evidenced by a single instrument of indebted- ness or the refinancing of a single loan shall
p.000983: not affect the insur- ance by the United States. If the loans thus consolidated are cov- ered by
p.000983: separate certificates of insurance issued under subsection (a), the Secretary may upon surrender of the
p.000983: original certificates issue a new certificate of insurance in accordance with that sub- section upon the
p.000983: consolidated obligation. If the loans thus consoli- dated are covered by a single comprehensive
p.000983: certificate issued under subsection (b), the Secretary may amend that certificate ac- cordingly.
p.000983: (e) RULE OF CONSTRUCTION REGARDING CONSOLIDATION OF DEBTS AND REFINANCING.—Nothing in this section
p.000983: shall be con- strued to preclude the lender and the borrower, by mutual agree- ment, from consolidating
p.000983: all of the borrower’s loans insured under this subpart into a single instrument (or, if the borrower
p.000983: obtained only 1 loan insured under this subpart, refinancing the loan 1 time) under the terms applicable to an
p.000983: insured loan made at the same time as the consolidation. The lender or loan holder should provide full information
p.000983: to the borrower concerning the advantages and dis- advantages of loan consolidation or refinancing. Nothing in
p.000983: this section shall be construed to preclude the consolidation of the bor- rower’s loans insured under this subpart
p.000983: under section 428C of the Higher Education Act of 1965. Any loans insured pursuant to this subpart that are
p.000983: consolidated under section 428C of such Act shall not be eligible for special allowance payments under section 438 of
p.000983: such Act.
p.000983: SEC. 707. ø292f¿ DEFAULT OF BORROWER.
p.000983: (a) CONDITIONS FOR PAYMENT TO BENEFICIARY.—
p.000983: (1) IN GENERAL.—Upon default by the borrower on any loan covered by Federal loan insurance pursuant to
p.000983: this sub- part, and after a substantial collection effort (including, subject to subsection (h), commencement and
p.000983: prosecution of an action) as determined under regulations of the Secretary, the insur- ance beneficiary shall
p.000983: promptly notify the Secretary and the Secretary shall, if requested (at that time or after further col-
p.000983: lection efforts) by the beneficiary, or may on his own motion, if the insurance is still in effect,
p.000983: pay to the beneficiary the
p.000983: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000989: and amounts of de- faults on loans guaranteed under this subpart. In carrying out such purpose the Office shall—
p.000989: (1) conduct analytical and evaluative studies concerning loans and loan defaults;
p.000989: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000991: 991
p.000991: PUBLIC HEALTH SERVICE ACT
p.000991: Sec. 710
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p.000991: January 30, 2020
p.000991: (2) carry out activities designed to reduce loan defaults;
p.000991: (3) respond to special circumstances that may exist in the financial lending environment that may lead to loan
p.000991: defaults;
p.000991: (4) coordinate with other Federal entities that are involved with student loan programs, including—
p.000991: (A) with respect to the Department of Education, in the development of a single student loan application form,
p.000991: a single student loan deferment form, a single disability form, and a central student loan database; and
p.000991: (B) with respect to the Department of Justice, in the recovery of payments from health professionals who
p.000991: have defaulted on loans guaranteed under this subpart; and
p.000991: (5) provide technical assistance to borrowers, lenders, hold- ers, and institutions concerning deferments and
p.000991: collection ac- tivities.
p.000991: (c) ADDITIONAL DUTIES.—In conjunction with the report sub- mitted under subsection (b), the Office shall—
p.000991: (1) compile, and publish in the Federal Register, a list of the borrowers who are in default under this
p.000991: subpart; and
p.000991: (2) send the report and notices of default with respect to these borrowers to relevant Federal agencies
p.000991: and to schools, school associations, professional and specialty associations, State licensing boards,
p.000991: hospitals with which such borrowers may be associated, and any other relevant organizations.
p.000991: (d) ALLOCATION OF FUNDS FOR OFFICE.—In the case of amounts reserved under section 710(a)(2)(B)
p.000991: for obligation under this subsection, the Secretary may obligate the amounts for the purpose of
p.000991: administering the Office, including 7 full-time equiva- lent employment positions for such Office. With
p.000991: respect to such purpose, amounts made available under the preceding sentence are in addition to amounts made
p.000991: available to the Health Resources and Services Administration for program management for the fiscal year
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p.001129: vidual based upon the fact that the individual in good faith re- ported information—
p.001129: (A) to the provider with the intention of having the in- formation reported to a patient safety organization; or
p.001129: (B) directly to a patient safety organization.
p.001129: (2) ADVERSE EMPLOYMENT ACTION.—For purposes of this subsection, an ‘‘adverse employment action’’ includes—
p.001129: (A) loss of employment, the failure to promote an indi- vidual, or the failure to provide any other employment-re-
p.001129: lated benefit for which the individual would otherwise be eligible; or
p.001129: (B) an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of
p.001129: the individual.
p.001129: (f) ENFORCEMENT.—
p.001129: (1) CIVIL MONETARY PENALTY.—Subject to paragraphs (2) and (3), a person who discloses identifiable patient
p.001129: safety work product in knowing or reckless violation of subsection (b) shall be subject to a civil monetary penalty of
p.001129: not more than $10,000 for each act constituting such violation.
p.001129: (2) PROCEDURE.—The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b)
p.001129: and the first sentence of subsection (c)(1), shall apply to civil money penalties under this subsection in
p.001129: the same manner as such provisions apply to a penalty or proceeding under section 1128A of the
p.001129: Social Security Act.
p.001129: (3) RELATION TO HIPAA.—Penalties shall not be imposed both under this subsection and under the
p.001129: regulations issued pursuant to section 264(c)(1) of the Health Insurance Port- ability and Accountability Act
p.001129: of 1996 (42 U.S.C. 1320d-2 note) for a single act or omission.
p.001129: (4) EQUITABLE RELIEF.—
p.001129: (A) IN GENERAL.—Without limiting remedies available to other parties, a civil action may be brought by any
p.001129: ag- grieved individual to enjoin any act or practice that vio- lates subsection (e) and to obtain other
p.001129: appropriate equi- table relief (including reinstatement, back pay, and res- toration of benefits) to redress
p.001129: such violation.
p.001129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001131: 1131
p.001131: PUBLIC HEALTH SERVICE ACT
p.001131: Sec. 922
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p.001131: January 30, 2020
p.001131: (B) AGAINST STATE EMPLOYEES.—An entity that is a State or an agency of a State government may not
p.001131: assert the privilege described in subsection (a) unless before the time of the assertion, the entity or, in the
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p.001131:
p.001131: Sec. 923 PUBLIC HEALTH SERVICE ACT 1132
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p.001131: January 30, 2020
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p.001131: make the draft report available for public comment and submit the draft report to the Institute of Medicine for review.
p.001131: (2) FINAL REPORT.—Not later than 1 year after the date de- scribed in paragraph (1), the Secretary shall submit a final
p.001131: re- port to the Congress.
p.001131: SEC. 923. ø299b–23¿ NETWORK OF PATIENT SAFETY DATABASES.
p.001131: (a) IN GENERAL.—The Secretary shall facilitate the creation of, and maintain, a network of patient safety
p.001131: databases that provides an interactive evidence-based management resource for providers, patient safety
p.001131: organizations, and other entities. The network of databases shall have the capacity to accept, aggregate
p.001131: across the network, and analyze nonidentifiable patient safety work product voluntarily reported by patient
p.001131: safety organizations, providers, or other entities. The Secretary shall assess the feasibility of pro-
p.001131: viding for a single point of access to the network for qualified re- searchers for information
p.001131: aggregated across the network and, if feasible, provide for implementation.
p.001131: (b) DATA STANDARDS.—The Secretary may determine common formats for the reporting to and among the network of
p.001131: patient safe- ty databases maintained under subsection (a) of nonidentifiable pa- tient safety work product,
p.001131: including necessary work product ele- ments, common and consistent definitions, and a standardized com- puter
p.001131: interface for the processing of such work product. To the ex- tent practicable, such standards shall be
p.001131: consistent with the ad- ministrative simplification provisions of part C of title XI of the So- cial Security Act.
p.001131: (c) USE OF INFORMATION.—Information reported to and among the network of patient safety databases under
p.001131: subsection (a) shall be used to analyze national and regional statistics, including trends and patterns of health
p.001131: care errors. The information resulting from such analyses shall be made available to the public and included
p.001131: in the annual quality reports prepared under section 913(b)(2).
p.001131: SEC. 924. ø299b–24¿ PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.
p.001131: (a) CERTIFICATION.—
p.001131: (1) INITIAL CERTIFICATION.—An entity that seeks to be a patient safety organization shall submit an initial
p.001131: certification to the Secretary that the entity—
p.001131: (A) has policies and procedures in place to perform each of the patient safety activities described in
p.001131: section 921(5); and
p.001131: (B) upon being listed under subsection (d), will comply with the criteria described in subsection (b).
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p.001139: methodologies and strategies for quality improvement practices in the deliv- ery of health care services
p.001139: that represent best practices (re- ferred to as ‘‘best practices’’) in health care quality, safety, and value; and
p.001139: (2) ensure that the Director is accountable for imple- menting a model to pursue such research
p.001139: in a collaborative manner with other related Federal agencies.
p.001139: (b) GENERAL FUNCTIONS OF THE CENTER.—The Center for Quality Improvement and Patient Safety of
p.001139: the Agency for Healthcare Research and Quality (referred to in this section as the ‘‘Center’’), or any other
p.001139: relevant agency or department designated by the Director, shall—
p.001139: (1) carry out its functions using research from a variety of disciplines, which may include epidemiology, health
p.001139: services, sociology, psychology, human factors engineering, biostatistics, health economics, clinical research,
p.001139: and health informatics;
p.001139: (2) conduct or support activities consistent with the pur- poses described in subsection (a), and for—
p.001139: (A) best practices for quality improvement practices in the delivery of health care services; and
p.001139: (B) that include changes in processes of care and the redesign of systems used by providers that will reliably
p.001139: re- sult in intended health outcomes, improve patient safety, and reduce medical errors (such as skill
p.001139: development for health care providers in team-based health care delivery and rapid cycle process
p.001139: improvement) and facilitate adop- tion of improved workflow;
p.001139: (3) identify health care providers, including health care systems, single institutions, and individual
p.001139: providers, that—
p.001139: (A) deliver consistently high-quality, efficient health care services (as determined by the Secretary); and
p.001139: (B) employ best practices that are adaptable and scal- able to diverse health care settings or effective in improv- ing
p.001139: care across diverse settings;
p.001139: (4) assess research, evidence, and knowledge about what strategies and methodologies are most effective in
p.001139: improving health care delivery;
p.001139: (5) find ways to translate such information rapidly and ef- fectively into practice, and document the sustainability of
p.001139: those improvements;
p.001139: (6) create strategies for quality improvement through the development of tools, methodologies, and
p.001139: interventions that can successfully reduce variations in the delivery of health care;
p.001139: (7) identify, measure, and improve organizational, human, or other causative factors, including those related to
p.001139: the cul-
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p.001177: findings then available from such research, in order to make maximum feasible progress toward identification of
p.001177: infants at risk of sudden infant death syndrome and prevention of sudden infant death syndrome.
p.001177: PART C—HEMOPHILIA PROGRAMS
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p.001177: January 30, 2020
p.001177: BLOOD SEPARATION CENTERS
p.001177: SEC. 1132. ø300c–22¿ (a) The Secretary may make grants to and enter into contracts with public and
p.001177: nonprofit private entities for projects to develop and expand, within existing facilities, blood- separation centers
p.001177: to separate and make available for distribution blood components to providers of blood services and
p.001177: manufacturers of blood fractions. For purposes of this section—
p.001177: (1) the term ‘‘blood components’’ means those constituents of whole blood which are used for therapy and
p.001177: which are ob- tained by physical separation processes which result in li- censed products such as red
p.001177: blood cells, platelets, white blood cells, AHF-rich plasma, fresh-frozen plasma, cryoprecipitate, and single
p.001177: unit plasma for infusion; and
p.001177: (2) the term ‘‘blood fractions’’ means those constituents of plasma which are used for therapy and which are
p.001177: obtained by licensed fractionation processes presently used in manufac- turing which result in licensed products
p.001177: such as normal serum albumin, plasma, protein fraction, prothrombin complex, fibrinogen, AHF
p.001177: concentrate, immune serum globulin, and hyperimmune globulins.
p.001177: (b) In the event the Secretary finds that there is an insufficient supply of blood fractions available to meet the
p.001177: needs for treatment of persons suffering from hemophilia, and that public and other nonprofit private
p.001177: centers already engaged in the production of blood fractions could alleviate such insufficiency with
p.001177: assistance under this subsection, he may make grants not to exceed $500,000 to such centers for the purposes of
p.001177: alleviating the insufficiency.
p.001177: (c) No grant or contract may be made under subsection (a) or
p.001177: (b) unless an application therefor has been submitted to and ap- proved by the Secretary. Such an application
p.001177: shall be in such form, submitted in such manner, and contain such information as the Secretary shall by
p.001177: regulation prescribe.
p.001177: (d) Contracts may be entered into under subsection (a) without regard to section 3648 and 3709 of the Revised Statutes
p.001177: (31 U.S.C. 529; 41 U.S.C. 5).
p.001177: (e) For the purpose of making payments under grants and con- tracts under subsections (a) and (b), there are authorized
p.001177: to be ap- propriated $4,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977,
p.001177: $3,450,000 for the fiscal year end- ing September 30, 1978, $2,500,000 for the fiscal year ending Sep- tember 30,
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p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
p.001295: health services to adults with a serious mental illness and to children with a se- rious emotional disturbance;
p.001295: (2) the plan meets the criteria specified in subsection (b);
p.001295: and
p.001295: (3) the plan is approved by the Secretary.
p.001295:
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p.001295: January 30, 2020
p.001295: (b) CRITERIA FOR PLAN.—In accordance with subsection (a), a State shall submit to the Secretary a plan every
p.001295: two years that, at a minimum, includes each of the following:
p.001295: (1) SYSTEM OF CARE.—A description of the State’s system of care that contains the following:
p.001295: (A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYS- TEMS.—The plan shall—
p.001295: (i) identify the single State agency to be respon- sible for the administration of the program under
p.001295: the grant, including any third party who administers men- tal health services and is responsible for complying
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: 1297
p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: January 30, 2020
p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
...

p.001321: State is seeking funds;
p.001321: (2) the application contains each funding agreement that is described in this subpart or subpart III for such a grant
p.001321: (other than any such agreement that is not applicable to the State);
p.001321: (3) the agreements are made through certification from the chief executive officer of the State;
p.001321: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001321: Secretary;
p.001321: (5) the application contains the report required in section 1942(a);
p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
...

p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
p.001343:
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p.001343: January 30, 2020
p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
p.001343: care services in a single setting or the capability of creating a network through which all care services
p.001343: would be provided; or
p.001343: (B) in the case of an organization which will provide prevention services, the capability of providing
p.001343: such serv- ices;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
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p.001343:
p.001343: Sec. 2002 PUBLIC HEALTH SERVICE ACT 1344
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p.001343: January 30, 2020
p.001343:
p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
...

p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345:
p.001347: 1347
p.001347: PUBLIC HEALTH SERVICE ACT
p.001347: Sec. 2005
p.001347:
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p.001347: January 30, 2020
p.001347: (1) serve an area where there is a high incidence of adoles- cent pregnancy;
p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
...

p.001351: adolescents and adolescent parents;
p.001351: (2) provide technical assistance to facilitate coordination by State and local recipients of Federal assistance;
p.001351: (3) review all programs administered by the Department of Health and Human Services which provide prevention services
p.001351: or care services to determine if the policies of such programs are consistent with the policies of this
p.001351: title, consult with other
p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001351:
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p.001351:
p.001351:
p.001353: 1353
p.001353: PUBLIC HEALTH SERVICE ACT
p.001353: Sec. 2008
p.001353:
p.001353: departments and agencies of the Federal Government who ad- minister programs that provide such services, and
p.001353: encourage such other departments and agencies to make recommenda- tions, as appropriate, for legislation to
p.001353: modify such programs in order to facilitate the use of all Government programs which provide such services as a
p.001353: basis for delivery of more com- prehensive prevention services and more comprehensive pro- grams of care for
p.001353: pregnant adolescents and adolescent parents;
p.001353: (4) give priority in the provision of funds, where appro- priate, to applicants using single or coordinated
p.001353: grant applica- tions for multiple programs; and
p.001353: (5) give priority, where appropriate, to the provision of funds under Federal programs administered by
p.001353: the Secretary (other than the program established by this title) to projects providing comprehensive
p.001353: prevention services and comprehen- sive programs of care for pregnant adolescents and adolescent parents.
p.001353: (b) Any recipient of a grant for a demonstration project for services under this title shall coordinate
p.001353: its activities with any other recipient of such a grant which is located in the same local- ity.
p.001353: RESEARCH
p.001353: SEC. 2008. ø300z–7¿ (a)(1) The Secretary may make grants and enter into contracts with public agencies
p.001353: or private organiza- tions or institutions of higher education to support the research and dissemination
p.001353: activities described in paragraphs (4), (5), and
p.001353: (6) of section 2001(b).
p.001353: (2) The Secretary may make grants or enter into contracts under this section for a period of one year.
p.001353: A grant or contract under this section for a project may be renewed for four additional one-year periods, which
p.001353: need not be consecutive.
p.001353: (3) A grant or contract for any one-year period under this sec- tion may not exceed $100,000 for the direct costs of
p.001353: conducting re- search or disemination 1 activities under this section and may in- clude such additional
p.001353: amounts for the indirect costs of conducting such activities as the Secretary determines appropriate. The
...

p.001419: services by the State under this part for the fiscal year;
p.001419: (B) information on the types of home and community- based health services so provided;
p.001419: (C) information on the average monthly costs of such services and a comparison of such costs with costs
p.001419: of pro- viding services in hospitals, nursing facilities, and similar institutions; and
p.001419: (D) such other information as the Secretary may re- quire to provide for an evaluation of the program
p.001419: under this part and its cost-effectiveness.
p.001419: (b) AUDITS.—
p.001419: (1) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State involved
p.001419: agrees to es- tablish such fiscal control and fund accounting procedures as may be necessary to ensure the
p.001419: proper disbursal of, and ac- counting for, amounts received by the State under such section.
p.001419: (2) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State involved
p.001419: agrees that—
p.001419: (A) the State will provide for—
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001421: 1421
p.001421: PUBLIC HEALTH SERVICE ACT
p.001421: Sec. 2406
p.001421:
p.001421: (i) a financial and compliance audit of such pay- ments; or
p.001421: (ii) a single financial and compliance audit of each entity administering such payments;
p.001421: (B) the audit will be performed biennially and will cover expenditures in each fiscal year; and
p.001421: (C) the audit will be conducted in accordance with standards established by the Comptroller General of
p.001421: the United States for the audit of governmental organizations, programs, activities, and functions.
p.001421: (3) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State involved
p.001421: agrees that, not later than 30 days after the completion of an audit under paragraph (2), the State will
p.001421: provide a copy of the audit report to the State legislature.
p.001421: (4) For purposes of paragraph (2), the term ‘‘financial and compliance audit’’ means an audit to determine whether the
p.001421: fi- nancial statements of an audited entity present fairly the fi- nancial position, and the results of
p.001421: financial operations, of the entity in accordance with generally accepted accounting prin- ciples, and whether
p.001421: the entity has complied with laws and reg- ulations that may have a material effect upon the financial
p.001421: statements.
p.001421: (c) AVAILABILITY TO PUBLIC.—The Secretary may not make payments under section 2401(a) unless the State involved
p.001421: agrees to make copies of the reports and audits described in this section available for public inspection.
p.001421: (d) EVALUATIONS BY COMPTROLLER GENERAL.—The Comp- troller General of the United States shall, from time to
p.001421: time, evalu- ate the expenditures by the States of payments under section 2401(a) in order to assure that
p.001421: expenditures are consistent with the provisions of this part.
p.001421: SEC. 2406. ø300dd–5¿ ADDITIONAL REQUIRED AGREEMENTS.
...

p.001433:
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p.001433:
p.001433: Sec. 2506 PUBLIC HEALTH SERVICE ACT 1434
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p.001433: January 30, 2020
p.001433:
p.001433: (3) determining whether the payments were expended in accordance with the purpose described in section
p.001433: 2501(b); and
p.001433: (4) determining the percentage of payments received pur- suant to such section that were expended by the
p.001433: State for ad- ministrative expenses during the preceding fiscal year.
p.001433: (b) AUDITS.—
p.001433: (1) The Secretary may not make payments under section 2501(a) for a fiscal year unless the State involved
p.001433: agrees to es- tablish such fiscal control and fund accounting procedures as may be necessary to ensure the
p.001433: proper disbursal of, and ac- counting for, amounts received by the State under such section.
p.001433: (2) The Secretary may not make payments under section 2501(a) for a fiscal year unless the State involved
p.001433: agrees that—
p.001433: (A) the State will provide for—
p.001433: (i) a financial and compliance audit of such pay- ments; or
p.001433: (ii) a single financial and compliance audit of each entity administering such payments;
p.001433: (B) the audit will be performed biennially and will cover expenditures in each fiscal year; and
p.001433: (C) the audit will be conducted in accordance with standards established by the Comptroller General of
p.001433: the United States for the audit of governmental organizations, programs, activities, and functions.
p.001433: (3) The Secretary may not make payments under section 2501(a) for a fiscal year unless the State involved
p.001433: agrees that, not later than 30 days after the completion of an audit under paragraph (2), the State will
p.001433: provide a copy of the audit report to the State legislature.
p.001433: (4) For purposes of paragraph (2), the term ‘‘financial and compliance audit’’ means an audit to determine whether the
p.001433: fi- nancial statements of an audited entity present fairly the fi- nancial position, and the results of
p.001433: financial operations, of the entity in accordance with generally accepted accounting prin- ciples, and whether
p.001433: the entity has complied with laws and reg- ulations that may have a material effect upon the financial
p.001433: statements.
p.001433: (c) AVAILABILITY TO PUBLIC.—The Secretary may not make payments under section 2501(a) for a fiscal year
p.001433: unless the State involved agrees to make copies of the reports and audits described in this section available for
p.001433: public inspection.
p.001433: (d) EVALUATIONS BY COMPTROLLER GENERAL.—The Comp- troller General of the United States shall, from time to
p.001433: time, evalu- ate the expenditures by States of payments received under section 2501(a) in order to ensure that
p.001433: expenditures are consistent with the provisions of this part.
p.001433: SEC. 2506. ø300ee–16¿ ADDITIONAL REQUIRED AGREEMENTS.
...

p.001447: such entities.
p.001447: (6) GRIEVANCE PROCEDURES.—A planning council under paragraph (1) shall develop procedures for addressing
p.001447: griev- ances with respect to funding under this subpart, including procedures for submitting grievances that
p.001447: cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning
p.001447: council and be consistent with the re- quirements of subsection (c).
p.001447: (7) PUBLIC DELIBERATIONS.—With respect to a planning council under paragraph (1), the following applies:
p.001447: (A) The council may not be chaired solely by an em- ployee of the grantee under section 2601(a).
p.001447: (B) In accordance with criteria established by the Sec- retary:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447: January 30, 2020
p.001447: (i) The meetings of the council shall be open to the public and shall be held only after adequate notice to
p.001447: the public.
p.001447: (ii) The records, reports, transcripts, minutes, agenda, or other documents which were made avail-
p.001447: able to or prepared for or by the council shall be avail-
p.001447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001447:
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p.001447:
p.001447: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1448
p.001447:
p.001447: able for public inspection and copying at a single loca- tion.
p.001447: (iii) Detailed minutes of each meeting of the coun- cil shall be kept. The accuracy of all minutes shall be certified
p.001447: to by the chair of the council.
p.001447: (iv) This subparagraph does not apply to any dis- closure of information of a personal nature that would
p.001447: constitute a clearly unwarranted invasion of personal privacy, including any disclosure of medical informa-
p.001447: tion or personnel matters.
p.001447: (c) 3 GRIEVANCE PROCEDURES.—
p.001447: (1) FEDERAL RESPONSIBILITY.—
p.001447: (A) MODELS.—The Secretary shall, through a process that includes consultations with grantees under this
p.001447: sub- part and public and private experts in grievance proce- dures, arbitration, and mediation, develop model
p.001447: grievance procedures that may be implemented by the planning council under subsection (b)(1) and
p.001447: grantees under this subpart. Such model procedures shall describe the ele- ments that must be addressed
p.001447: in establishing local griev- ance procedures and provide grantees with flexibility in the design of such
p.001447: local procedures.
p.001447: (B) REVIEW.—The Secretary shall review grievance procedures established by the planning council and
p.001447: grant- ees under this subpart to determine if such procedures are adequate. In making such a determination, the
p.001447: Secretary shall assess whether such procedures permit legitimate grievances to be filed, evaluated, and resolved
p.001447: at the local level.
p.001447: (2) GRANTEES.—To be eligible to receive funds under this subpart, a grantee shall develop grievance procedures
p.001447: that are determined by the Secretary to be consistent with the model procedures developed under paragraph
...

p.001453: result of the limitation under clause (i) shall be made available by the Secretary as
p.001453: additional amounts for grants pursuant to subsection (b) for the fiscal year involved, subject to
p.001453: paragraph (4) and sec- tion 2610(d)(2).
p.001453: (4) INCREASES IN GRANT.—
p.001453: (A) IN GENERAL.—For each eligible area that received a grant pursuant to this subsection for fiscal
p.001453: year 2009, the Secretary shall, for each of the fiscal years 2010 through 2013, increase the amount
p.001453: of the grant made pur- suant to paragraph (3) for the area to ensure that the amount of the grant for the
p.001453: fiscal year involved is not less than the following amount, as applicable to such fiscal year:
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p.001453: (i) For fiscal year 2010, an amount equal to 95 percent of the sum of the amount of the grant made
p.001453: pursuant to paragraph (3) and this paragraph for fis- cal year 2009.
p.001453: (ii) For each of the fiscal years 2011 and 2012, an amount equal to 100 percent of the amount of the grant
p.001453: made pursuant to paragraph (3) and this para- graph for fiscal year 2010.
p.001453: (iii) For fiscal year 2013, an amount equal to 92.5 percent of the amount of the grant made pursuant to
p.001453: paragraph (3) and this paragraph for fiscal year 2012.
p.001453: (B) SOURCE OF FUNDS FOR INCREASE.—
p.001453: (i) IN GENERAL.—From the amounts available for carrying out the single program referred to in section
p.001453: 2609(d)(2)(C) for a fiscal year (relating to supple- mental grants), the Secretary shall make
p.001453: available such amounts as may be necessary to comply with subparagraph (A), subject to section 2610(d)(2).
p.001453: (ii) PRO RATA REDUCTION.—If the amounts re- ferred to in clause (i) for a fiscal year are
p.001453: insufficient to fully comply with subparagraph (A) for the year, the Secretary, in order to provide the additional
p.001453: funds nec- essary for such compliance, shall reduce on a pro rata basis the amount of each grant pursuant to
p.001453: this sub-
p.001453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001453: section for the fiscal year, other than grants for eligi- ble areas for which increases under
...

p.001463: applicable, to develop strategies for ensuring that such services are consistent with the guide- lines for
p.001463: improvement in the access to and quality of HIV health services.
p.001463: (B) USE OF FUNDS.—
p.001463: (i) IN GENERAL.—From amounts received under a grant awarded under this subpart for a fiscal year, the chief
p.001463: elected official of an eligible area may use for ac- tivities associated with the clinical quality manage- ment
p.001463: program required in subparagraph (A) not to ex- ceed the lesser of—
p.001463: (I) 5 percent of amounts received under the grant; or
p.001463: (II) $3,000,000.
p.001463: (ii) RELATION TO LIMITATION ON ADMINISTRATIVE EXPENSES.—The costs of a clinical quality manage- ment
p.001463: program under subparagraph (A) may not be considered administrative expenses for purposes of the limitation
p.001463: established in paragraph (1).
p.001463: (i) CONSTRUCTION.—A chief elected official may not use amounts received under a grant awarded under
p.001463: this subpart to purchase or improve land, or to purchase, construct, or perma- nently improve (other
p.001463: than minor remodeling) any building or other facility, or to make cash payments to intended recipients
p.001463: of services.
p.001463: SEC. 2605. ø300ff–15¿ APPLICATION.
p.001463: (a) IN GENERAL.—To be eligible to receive a grant under sec- tion 2601, an eligible area shall prepare
p.001463: and submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001463: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001463: shall require, in- cluding assurances adequate to ensure—
p.001463: (1)(A) that funds received under a grant awarded under this subpart will be utilized to supplement not
p.001463: supplant State funds made available in the year for which the grant is award- ed to provide HIV-related
p.001463: services as described in section 2604(b)(1);
p.001463: (B) that the political subdivisions within the eligible area will maintain the level of expenditures by
p.001463: such political sub- divisions for HIV-related services as described in section 2604(b)(1) at a level
p.001463: that is equal to the level of such expendi- tures by such political subdivisions for the preceding fiscal year;
p.001463: and
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001463:
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p.001465: PUBLIC HEALTH SERVICE ACT
p.001465: Sec. 2605
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p.001465: January 30, 2020
p.001465: agency responsible for administering grants under part B, and ensure that the services provided under the
p.001465: comprehensive plan are consistent with the statewide coordinated statement of need;
p.001465: (9) that the eligible area has procedures in place to ensure that services provided with funds received under
p.001465: this subpart meet the criteria specified in section 2604(b)(1); and
p.001465: (10) that the chief elected official will submit to the lead State agency under section 2617(b)(4),
p.001465: audits, consistent with Office of Management and Budget circular A133, regarding funds expended in
p.001465: accordance with this subpart every 2 years and shall include necessary client-based data to compile unmet need
p.001465: calculations and Statewide coordinated statements of need process.
p.001465: (b) APPLICATION.—An eligible area that desires to receive a grant under section 2603(b) shall prepare and
p.001465: submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001465: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001465: shall require, in- cluding the information required under such subsection and infor- mation concerning—
p.001465: (1) the number of individuals to be served within the eligi- ble area with assistance provided under the grant,
p.001465: including the identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of section
p.001465: 2603(b)(2)(A);
p.001465: (2) demographic data on the population of such individ- uals;
p.001465: (3) the average cost of providing each category of HIV-re- lated health services and the extent to which such
p.001465: cost is paid by third-party payors;
p.001465: (4) the aggregate amounts expended for each such category of services;
p.001465: (5) the manner in which the expected expenditures are re- lated to the planning process for States that receive
p.001465: funding under part B (including the planning process described in sec- tion 2617(b)); and
p.001465: (6) the expected expenditures and how those expenditures will improve overall client outcomes, as
p.001465: described under the State plan under section 2617(b), and through additional out- comes measures as
p.001465: identified by the HIV health services plan- ning council under section 2602(b).
p.001465: (c) SINGLE APPLICATION AND GRANT AWARD.—
p.001465: (1) APPLICATION.—The Secretary may phase in the use of a single application that meets the requirements of
p.001465: subsections
p.001465: (a) and (b) of section 2603 with respect to an eligible area that desires to receive grants under section 2603
p.001465: for a fiscal year.
p.001465: (2) GRANT AWARD.—The Secretary may phase in the awarding of a single grant to an eligible area that
p.001465: submits an approved application under paragraph (1) for a fiscal year.
p.001465: (d) DATE CERTAIN FOR SUBMISSION.—
p.001465: (1) REQUIREMENT.—Except as provided in paragraph (2), to be eligible to receive a grant under section 2601(a) for a
p.001465: fiscal year, an application under subsection (a) shall be submitted
p.001465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001465: Sec. 2605 PUBLIC HEALTH SERVICE ACT 1466
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p.001465: January 30, 2020
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p.001465: not later than 45 days after the date on which appropriations are made under section 2677 for the fiscal
p.001465: year.
p.001465: (2) EXCEPTION.—The Secretary may extend the time for the submission of an application under paragraph (1) for a
p.001465: pe- riod of not to exceed 60 days if the Secretary determines that the eligible area has made a good
...

p.001469: Sec. 2609
p.001469:
p.001469: (1) ADMINISTRATION; PLANNING COUNCIL.—
p.001469: (A) IN GENERAL.—The provisions of section 2602 apply with respect to a grant under subsection (a) for a
p.001469: transi- tional area to the same extent and in the same manner as such provisions apply with respect to a grant
p.001469: under sub- part I for an eligible area, except that, subject to subpara- graph (B), the chief elected official of the
p.001469: transitional area may elect not to comply with the provisions of section 2602(b) if the official provides
p.001469: documentation to the Sec- retary that details the process used to obtain community input (particularly
p.001469: from those with HIV) in the transi- tional area for formulating the overall plan for priority set- ting and
p.001469: allocating funds from the grant under subsection (a).
p.001469: (B) EXCEPTION.—For each of the fiscal years 2007
p.001469: through 2013, the exception described in subparagraph (A) does not apply if the transitional area involved
p.001469: received funding under subpart I for fiscal year 2006.
p.001469: (2) TYPE AND DISTRIBUTION OF GRANTS; TIMEFRAME FOR OB- LIGATION AND EXPENDITURE OF GRANT FUNDS.—
p.001469: (A) FORMULA GRANTS; SUPPLEMENTAL GRANTS.—The provisions of section 2603 apply with respect to grants
p.001469: under subsection (a) to the same extent and in the same manner as such provisions apply with respect
p.001469: to grants under subpart I, subject to subparagraphs (B) and (C).
p.001469: (B) FORMULA GRANTS; INCREASE IN GRANT.—For pur- poses of subparagraph (A), section 2603(a)(4) does
p.001469: not apply.
p.001469: (C) SUPPLEMENTAL GRANTS; SINGLE PROGRAM WITH SUBPART I PROGRAM.—With respect to section 2603(b)
p.001469: as applied for purposes of subparagraph (A):
p.001469: (i) The Secretary shall combine amounts available pursuant to such subparagraph with amounts avail- able for
p.001469: carrying out section 2603(b) and shall admin- ister the two programs as a single program.
p.001469: (ii) In the single program, the Secretary has dis- cretion in allocating amounts between eligible areas
p.001469: under subpart I and transitional areas under this sec- tion, subject to the eligibility criteria that apply under such
p.001469: section, and subject to section 2603(b)(2)(C) (re- lating to priority in making grants).
p.001469: (iii) Pursuant to section 2603(b)(1), amounts for the single program are subject to use under sections
p.001469: 2603(a)(4) and 2610(d)(1).
p.001469: (3) APPLICATION; TECHNICAL ASSISTANCE; DEFINITIONS.— The provisions of sections 2605, 2606, and 2607 apply with
p.001469: re- spect to grants under subsection (a) to the same extent and in the same manner as such provisions apply with
p.001469: respect to grants under subpart I.
p.001469:
p.001469:
p.001469: January 30, 2020 As Amended Through P.L. 116-94,
p.001469: Enacted December 20, 2019
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p.001469: Sec. 2610 PUBLIC HEALTH SERVICE ACT
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p.001469: Subpart III—General Provisions
p.001470: 1470
p.001470:
p.001470: SEC. 2610. ø300ff–20¿ AUTHORIZATION OF APPROPRIATIONS.
p.001470: (a) IN GENERAL.—For the purpose of carrying out this part, there are authorized to be appropriated
p.001470: $604,000,000 for fiscal year 2007, $626,300,000 for fiscal year 2008, $649,500,000 for fiscal year 2009, $681,975,000
p.001470: for fiscal year 2010, $716,074,000 for fiscal year 2011, $751,877,000 for fiscal year 2012, and $789,471,000 for fiscal
p.001470: year 2013. Amounts appropriated under the preceding sentence for a fiscal year are available for obligation by the
p.001470: Secretary until the end of the second succeeding fiscal year.
p.001470: (b) RESERVATION OF AMOUNTS.—
p.001470: (1) FISCAL YEAR 2007.—Of the amount appropriated under subsection (a) for fiscal year 2007, the Secretary
p.001470: shall re- serve—
p.001470: (A) $458,310,000 for grants under subpart I; and
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p.001471: reduction for such fiscal year under subparagraph (A), less the amount transferred for such fiscal
p.001471: year under subclause (I).
p.001471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001471: Sec. 2611 PUBLIC HEALTH SERVICE ACT 1472
p.001471:
p.001471: (3) If a metropolitan area is a transitional area under sec- tion 2609 for a fiscal year, but for a subsequent
p.001471: fiscal year qualifies as an eligible area under subpart I—
p.001471: (A) the amount reserved under subsection (b)(2)(B) of this section for the first such subsequent fiscal year of
p.001471: be- coming an eligible area is deemed to be reduced by an amount equal to the amount of the grant
p.001471: that, pursuant to section 2603(a), was made under section 2609(d)(2)(A) for the metropolitan area for the
p.001471: preceding fiscal year; and
p.001471: (B) the amount reserved under subsection (b)(2)(A) for such fiscal year is deemed to be increased by an
p.001471: amount equal to the amount of the reduction under subparagraph
p.001471: (A) for such year.
p.001471: (d) CERTAIN TRANSFERS; ALLOCATIONS BETWEEN PROGRAMS UNDER SUBPART I.—With respect to paragraphs
p.001471: (1)(B)(i) and (2)(A)(ii) of subsection (c), the Secretary shall administer any re- ductions under such
p.001471: paragraphs for a fiscal year in accordance with the following:
p.001471: (1) The reductions shall be made from amounts available for the single program referred to in section
p.001471: 2609(d)(2)(C) (re- lating to supplemental grants).
p.001471: (2) The reductions shall be made before the amounts re- ferred to in paragraph (1) are used for
p.001471: purposes of section 2603(a)(4).
p.001471: (3) If the amounts referred to in paragraph (1) are not suf- ficient for making all the reductions, the reductions
p.001471: shall be re- duced until the total amount of the reductions equals the total of the amounts referred to in such
p.001471: paragraph.
p.001471: (e) RULES OF CONSTRUCTION REGARDING FIRST SUBSEQUENT FISCAL YEAR.—Paragraphs (1) and (2) of subsection
p.001471: (c) apply with respect to each series of fiscal years during which a metropolitan area is an eligible
p.001471: area under subpart I or a transitional area under section 2609 for a fiscal year and then for a subsequent fis-
p.001471: cal year ceases to be such an area by reason of section 2601(b) or 2609(c)(2), respectively, rather
p.001471: than applying to a single such se- ries. Paragraph (3) of subsection (c) applies with respect to each se- ries
p.001471: of fiscal years during which a metropolitan area is a transi- tional area under section 2609 for a fiscal
p.001471: year and then for a sub- sequent fiscal year becomes an eligible area under subpart I, rather than applying to a single
p.001471: such series.
p.001471: PART B—CARE GRANT PROGRAM 6
p.001471: Subpart I—General Grant Provisions
p.001471: SEC. 2611. ø300ff–21¿ GRANTS.
p.001471: The Secretary shall, subject to the availability of appropria- tions, make grants to States to enable
p.001471: such States to improve the quality, availability and organization of health care and support services for
p.001471: individuals and families with HIV/AIDS. The authority
p.001471:
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p.001471: January 30, 2020
p.001471: 6 See footnote at the beginning of part A.
p.001471: Section 8(a) of Public Law 104–146 (110 Stat. 1372) establishes a condition for the receipt of grants under part B.
p.001471: The condition relates to notification of spouses of HIV-infected patients.
p.001471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: PUBLIC HEALTH SERVICE ACT
p.001473: Sec. 2612
p.001473:
p.001473: of the Secretary to provide grants under part B is subject to section 2626(e)(2) (relating to the decrease in
p.001473: perinatal transmission of HIV/AIDS).
p.001473: SEC. 2612. ø300ff–22¿ GENERAL USE OF GRANTS.
p.001473: (a) IN GENERAL.—A State may use amounts provided under grants made under section 2611 for—
p.001473: (1) core medical services described in subsection (b);
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p.001475: access and services and those who reside in historically underserved communities;
p.001475: (B) the service plan established under subsection (c)(2) by such consortium is consistent with the comprehensive
p.001475: plan under section 2617(b)(4) and addresses the special care and service needs of the populations and
p.001475: subpopula- tions identified under subparagraph (A); and
p.001475: (C) except as provided in paragraph (2), the consor- tium will be a single coordinating entity that will
p.001475: integrate the delivery of services among the populations and sub- populations identified under subparagraph
p.001475: (A).
p.001475: (2) EXCEPTION.—Subparagraph (C) of paragraph (1) shall not apply to any applicant consortium that the
p.001475: State deter- mines will operate in a community or locality in which it has been demonstrated by the
p.001475: applicant consortium that—
p.001475: (A) subpopulations exist within the community to be served that have unique service requirements; and
p.001475: (B) such unique service requirements cannot be ade- quately and efficiently addressed by a single
p.001475: consortium serving the entire community or locality.
p.001475: (c) APPLICATION.—
p.001475: (1) IN GENERAL.—To receive assistance from the State under subsection (a), a consortium shall prepare and submit
p.001475: to the State, an application that—
p.001475: (A) demonstrates that the consortium includes agen- cies and community-based organizations—
p.001475: (i) with a record of service to populations and sub- populations with HIV/AIDS requiring care within the
p.001475: community to be served; and
p.001475: (ii) that are representative of populations and sub- populations reflecting the local incidence of HIV and that
p.001475: are located in areas in which such populations re- side;
p.001475: (B) demonstrates that the consortium has carried out an assessment of service needs within the geographic area
p.001475: to be served and, after consultation with the entities de- scribed in paragraph (2), has established a plan to
p.001475: ensure the delivery of services to meet such identified needs that shall include—
p.001475: (i) assurances that service needs will be addressed through the coordination and expansion of existing programs
p.001475: before new programs are created;
p.001475: (ii) assurances that, in metropolitan areas, the ge- ographic area to be served by the consortium cor- responds
p.001475: to the geographic boundaries of local health and support services delivery systems to the extent
p.001475: practicable;
p.001475: (iii) assurances that, in the case of services for in- dividuals residing in rural areas, the applicant consor- tium
p.001475: shall deliver case management services that link available community support services to appropriate specialized
p.001475: medical services; and
...

p.001581: draft of the guidance.
p.001581: (b) CONSTRUCTION.—Nothing in this section shall be construed—
p.001581: (1) as requiring a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage to provide any mental health or substance use disorder benefits; or
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p.001581: (2) in the case of a group health plan or a health insurance issuer offering group or individual health insurance
p.001581: coverage that provides mental health or substance use disorder benefits, as affecting the terms and conditions
p.001581: of the plan or coverage relating to such benefits under the plan or coverage, except as provided in subsection (a).
p.001581: (c) EXEMPTIONS.—
p.001581: (1) SMALL EMPLOYER EXEMPTION.—This section shall not apply to any group health plan and a health
p.001581: insurance issuer offering group or individual health insurance coverage for any plan year of a small employer
p.001581: (as defined in section 2791(e)(4), except that for purposes of this paragraph such term shall in- clude employers with
p.001581: 1 employee in the case of an employer re- siding in a State that permits small groups to include a single individual).
p.001581: (2) COST EXEMPTION.—
p.001581: (A) IN GENERAL.—With respect to a group health plan or a health insurance issuer offering group or individual
p.001581: health insurance coverage, if the application of this section to such plan (or coverage) results in an increase
p.001581: for the plan year involved of the actual total costs of coverage with respect to medical and surgical
p.001581: benefits and mental health and substance use disorder benefits under the plan (as determined and certified under
p.001581: subparagraph (C)) by an amount that exceeds the applicable percentage de- scribed in subparagraph
p.001581: (B) of the actual total plan costs, the provisions of this section shall not apply to such plan (or
p.001581: coverage) during the following plan year, and such ex- emption shall apply to the plan (or coverage)
p.001581: for 1 plan year. An employer may elect to continue to apply mental health and substance use disorder
p.001581: parity pursuant to this section with respect to the group health plan (or coverage) involved regardless of any
p.001581: increase in total costs.
p.001581: (B) APPLICABLE PERCENTAGE.—With respect to a plan (or coverage), the applicable percentage described
p.001581: in this subparagraph shall be—
p.001581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001583: PUBLIC HEALTH SERVICE ACT
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p.001587: January 30, 2020
p.001587: 14 There is a subpart II (roman II) beginning with section 2711.
p.001587: 15 The numerical sequence of section enumerators beginning in subpart 2 so in law. See sec- tion
p.001587: enumerators at the end of subpart 1 of this part and amendments redesignating section enumerators in
p.001587: subpart 2 by section 1001(4) and section 1563(c)(12) of Public Law 111–148. See footnote accompanying section 2725
p.001587: regarding ambiguity in placement of sections 2725–2728.
p.001587: There are conflicting amendments made to provisions of this section by section 1563(a) and section
p.001587: 1563(c)(12)(B) (relating to conforming amendments—originally designated as section 1562 and redesignated as
p.001587: section 1563 by section 10107(b)(1)) of Public Law 111–148). The amendments reflected here are from
p.001587: section 1563(a) of such Public Law and thereby renders the global amendment made by subsection (c)(12)(B)
p.001587: unexecutable.
p.001587: 16 The references to ‘‘subparts 1 and 2’’ probably should read ‘‘subparts I and II’’.
p.001587: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001587:
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p.001587: Sec. 2722 PUBLIC HEALTH SERVICE ACT 1588
p.001587:
p.001587: (B) PERIOD OF ELECTION.—An election under subpara- graph (A) shall apply—
p.001587: (i) for a single specified plan year, or
p.001587: (ii) in the case of a plan provided pursuant to a collective bargaining agreement, for the term of
p.001587: such agreement.
p.001587: An election under clause (i) may be extended through sub- sequent elections under this paragraph.
p.001587: (C) NOTICE TO ENROLLEES.—Under such an election, the plan shall provide for—
p.001587: (i) notice to enrollees (on an annual basis and at the time of enrollment under the plan) of the fact and
p.001587: consequences of such election, and
p.001587: (ii) certification and disclosure of creditable cov- erage under the plan with respect to enrollees in
p.001587: ac- cordance with section 2701(e).
p.001587: (D) ELECTION NOT APPLICABLE TO REQUIREMENTS CON- CERNING GENETIC INFORMATION.—The election described in
p.001587: subparagraph (A) shall not be available with respect to the provisions of subsections (a)(1)(F), (b)(3), (c), and (d)
p.001587: of sec- tion 2702 and the provisions of sections 2701 and 2702(b) to the extent that such provisions apply to
p.001587: genetic informa- tion.
p.001587: (E) ELECTION NOT APPLICABLE.—The election described in subparagraph (A) shall not be available with respect to
p.001587: the provisions of subparts I and II.
p.001587: (b) EXCEPTION FOR CERTAIN BENEFITS.—The requirements of subparts 1 and 2 17 shall not apply to any
p.001587: individual coverage or any group health plan (or group health insurance coverage) in rela- tion to its
p.001587: provision of excepted benefits described in section 2791(c)(1).
p.001587: (c) EXCEPTION FOR CERTAIN BENEFITS IF CERTAIN CONDITIONS MET.—
p.001587: (1) LIMITED, EXCEPTED BENEFITS.—The requirements of
p.001587: subparts 1 and 2 17 shall not apply to any individual coverage or any group health plan (and group health
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p.001617: PUBLIC HEALTH SERVICE ACT
p.001617: Sec. 2793
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p.001617: January 30, 2020
p.001617: days during the preceding calendar year and who employs at least 1 employees on the first day of the plan
p.001617: year.
p.001617: (5) SMALL GROUP MARKET.—The term ‘‘small group mar- ket’’ means the health insurance market under which
p.001617: individ- uals obtain health insurance coverage (directly or through any arrangement) on behalf of themselves (and
p.001617: their dependents) through a group health plan maintained by a small employer.
p.001617: (6) APPLICATION OF CERTAIN RULES IN DETERMINATION OF EMPLOYER SIZE.—For purposes of this subsection—
p.001617: (A) APPLICATION OF AGGREGATION RULE FOR EMPLOY- ERS.—all persons treated as a single employer under sub-
p.001617: section (b), (c), (m), or (o) of section 414 of the Internal Revenue Code of 1986 shall be treated as 1
p.001617: employer.
p.001617: (B) EMPLOYERS NOT IN EXISTENCE IN PRECEDING YEAR.—In the case of an employer which was not in exist-
p.001617: ence throughout the preceding calendar year, the deter- mination of whether such employer is a small or large
p.001617: em- ployer shall be based on the average number of employees that it is reasonably expected such employer will
p.001617: employ on business days in the current calendar year.
p.001617: (C) PREDECESSORS.—Any reference in this subsection to an employer shall include a reference to any predecessor
p.001617: of such employer.
p.001617: (7) STATE OPTION TO EXTEND DEFINITION OF SMALL EM- PLOYER.—Notwithstanding paragraphs (2) and (4),
p.001617: nothing in this section shall prevent a State from applying this subsection by treating as a small employer,
p.001617: with respect to a calendar year and a plan year, an employer who employed an average of at least 1 but
p.001617: not more than 100 employees on business days during the preceding calendar year and who employs at least 1
p.001617: employee on the first day of the plan year.
p.001617: SEC. 2792. ø300gg–92¿ REGULATIONS.
p.001617: The Secretary, consistent with section 104 of the Health Care Portability and Accountability Act of 1996,
p.001617: may promulgate such regulations as may be necessary or appropriate to carry out the provisions of this
p.001617: title. The Secretary may promulgate any interim final rules as the Secretary determines are appropriate to carry out
p.001617: this title.
...

p.001665: (vii) such other members are appointed by the Comptroller General of the United States; and
p.001665: (B) at least reflect providers, ancillary health care workers, consumers, purchasers, health plans, health
p.001665: in- formation technology developers, researchers, patients, rel- evant Federal agencies, and individuals with technical
p.001665: ex-
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001669: PUBLIC HEALTH SERVICE ACT
p.001669: Sec. 3002
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p.001669: January 30, 2020
p.001669: pertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of
p.001669: health information, including the use standards for such activity.
p.001669: (3) PARTICIPATION.—The members of the HIT Advisory Committee shall represent a balance among various
p.001669: sectors of the health care system so that no single sector unduly influ- ences the recommendations of the
p.001669: Committee.
p.001669: (4) TERMS.—
p.001669: (A) IN GENERAL.—The terms of the members of the HIT Advisory Committee shall be for 3 years, except
p.001669: that the Secretary shall designate staggered terms of the mem- bers first appointed.
p.001669: (B) VACANCIES.—Any member appointed to fill a va- cancy in the membership of the HIT Advisory Committee
p.001669: that occurs prior to the expiration of the term for which the member’s predecessor was appointed
p.001669: shall be ap- pointed only for the remainder of that term. A member may serve after the expiration of that
p.001669: member’s term until a successor has been appointed. A vacancy in the HIT Ad- visory Committee shall be filled in
p.001669: the manner in which the original appointment was made.
p.001669: (C) LIMITS.—Members of the HIT Advisory Committee shall be limited to two 3-year terms, for a total of not
p.001669: to exceed 6 years of service on the Committee.
p.001669: (5) OUTSIDE INVOLVEMENT.—The HIT Advisory Committee shall ensure an opportunity for the participation in
p.001669: activities of the Committee of outside advisors, including individuals with expertise in the development of
p.001669: policies and standards for the electronic exchange and use of health information, includ- ing in the areas of
p.001669: health information privacy and security.
p.001669: (6) QUORUM.—A majority of the members of the HIT Advi- sory Committee shall constitute a quorum for purposes of vot-
p.001669: ing, but a lesser number of members may meet and hold hear- ings.
p.001669: (7) CONSIDERATION.—The National Coordinator shall en- sure that the relevant and available recommendations
...

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p.001673: January 30, 2020
p.001673:
p.001673: (2) DEFINITION.—For purposes of this section, the term ‘‘HIPAA privacy and security law’’ means—
p.001673: (A) the provisions of part C of title XI of the Social Se- curity Act, section 264 of the Health Insurance Portability
p.001673: and Accountability Act of 1996, and subtitle D of title IV of the Health Information Technology for
p.001673: Economic and Clinical Health Act; and
p.001673: (B) regulations under such provisions.
p.001673: (b) FLEXIBILITY.—In administering the provisions of this title, the Secretary shall have flexibility in
p.001673: applying the definition of health care provider under section 3000(3), including the authority to omit certain
p.001673: entities listed in such definition when applying such definition under this title, where appropriate.
p.001673: (c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH IN-
p.001673: FORMATION THROUGH HEALTH INFORMATION EXCHANGES.—
p.001673: (1) IN GENERAL.—The Secretary shall use existing authori- ties to encourage partnerships between health
p.001673: information ex- change organizations and networks and health care providers, health plans, and other
p.001673: appropriate entities with the goal of of- fering patients access to their electronic health information in a
p.001673: single, longitudinal format that is easy to understand, se- cure, and may be updated automatically.
p.001673: (2) EDUCATION OF PROVIDERS.—The Secretary, in coordina- tion with the Office for Civil Rights of the
p.001673: Department of Health and Human Services, shall—
p.001673: (A) educate health care providers on ways of leveraging the capabilities of health information
p.001673: exchanges (or other relevant platforms) to provide patients with ac- cess to their electronic health
p.001673: information;
p.001673: (B) clarify misunderstandings by health care providers about using health information exchanges (or other rel-
p.001673: evant platforms) for patient access to electronic health in- formation; and
p.001673: (C) to the extent practicable, educate providers about health information exchanges (or other relevant
p.001673: platforms) that employ some or all of the capabilities described in paragraph (1).
p.001673: (3) REQUIREMENTS.—In carrying out paragraph (1), the Secretary, in coordination with the Office for Civil Rights,
p.001673: shall issue guidance to health information exchanges related to best practices to ensure that the electronic
p.001673: health information pro- vided to patients is—
p.001673: (A) private and secure;
p.001673: (B) accurate;
p.001673: (C) verifiable; and
p.001673: (D) where a patient’s authorization to exchange infor- mation is required by law, easily exchanged
p.001673: pursuant to such authorization.
p.001673: (4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to preempt State laws applicable to
...

p.001675: awareness that an individual has a right of access to in- spect, obtain a copy of, and transmit to a
p.001675: third party a copy of such individual’s protected health information pur- suant to the Health Information
p.001675: Portability and Account- ability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations),
p.001675: the Director of the Office for Civil Rights, in consultation with the National Coordi- nator, shall assist
p.001675: individuals and health care providers in understanding a patient’s rights to access and protect per- sonal health
p.001675: information under the Health Insurance Port- ability and Accountability Act of 1996 (Public Law 104– 191),
p.001675: including providing best practices for requesting per- sonal health information in a computable format, including using
p.001675: patient portals or third-party applications and com- mon cases when a provider is permitted to exchange
p.001675: and provide access to health information.
p.001675: (2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the
p.001675: National Coordinator may require that—
p.001675: (A) the certification criteria support—
p.001675: (i) patient access to their electronic health infor- mation, including in a single longitudinal format
p.001675: that is easy to understand, secure, and may be updated automatically;
p.001675: (ii) the patient’s ability to electronically commu- nicate patient-reported information (such as family
p.001675: history and medical history); and
p.001675: (iii) patient access to their personal electronic health information for research at the option of the pa-
p.001675: tient; and
p.001675: (B) the HIT Advisory Committee develop and prioritize standards, implementation specifications,
p.001675: and certification criteria required to help support patient ac- cess to electronic health information, patient
p.001675: usability, and support for technologies that offer patients access to their electronic health information in
p.001675: a single, longitudinal for-
p.001675: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001675: Sec. 3009A PUBLIC HEALTH SERVICE ACT 1676
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p.001675:
p.001675: mat that is easy to understand, secure, and may be up- dated automatically.
p.001675: SEC. 3009A. ø300jj–19a¿ ELECTRONIC HEALTH RECORD REPORTING PROGRAM.
p.001675: (a) REPORTING CRITERIA.—
p.001675: (1) CONVENING OF STAKEHOLDERS.—Not later than 1 year after the date of enactment of the 21st Century Cures
p.001675: Act, the Secretary shall convene stakeholders, as described in para- graph (2), for the purpose of
p.001675: developing the reporting criteria in accordance with paragraph (3).
p.001675: (2) DEVELOPMENT OF REPORTING CRITERIA.—The reporting criteria under this subsection shall be developed
...

p.001707: Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii)
p.001707: available to health researchers and others as provided in the CDC/ ATSDR Policy on Releasing and Sharing
p.001707: Data.
p.001707: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001707:
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p.001709: 1709
p.001709: PUBLIC HEALTH SERVICE ACT
p.001709: Sec. 3305
p.001709:
p.001709: (3) AUTHORITY FOR CONTRACTS TO BE CLASS SPECIFIC.—A contract entered into under this subsection with a
p.001709: Clinical Center of Excellence or a Data Center may be with respect to one or more class of enrolled WTC
p.001709: responders, screening-eligi- ble WTC survivors, or certified-eligible WTC survivors.
p.001709: (4) USE OF COOPERATIVE AGREEMENTS.—Any contract under this title between the WTC Program Administrator and
p.001709: a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.
p.001709: (5) REVIEW ON FEASIBILITY OF CONSOLIDATING DATA CEN- TERS.—Not later than July 1, 2011, the Comptroller General
p.001709: of the United States shall submit to the Committee on Energy and Commerce of the House of
p.001709: Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate a report
p.001709: on the feasibility of consolidating Data Centers into a single Data Center.
p.001709: (b) CENTERS OF EXCELLENCE.—
p.001709: (1) CLINICAL CENTERS OF EXCELLENCE.—
p.001709: (A) DEFINITION.—For purposes of this title, the term ‘‘Clinical Center of Excellence’’ means a Center
p.001709: that dem- onstrates to the satisfaction of the Administrator that the Center—
p.001709: (i) uses an integrated, centralized health care pro- vider approach to create a comprehensive suite of
p.001709: health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC sur-
p.001709: vivors, or certified-eligible WTC survivors;
p.001709: (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes
p.001709: health care providers who have been trained pursuant to section 3313(c);
p.001709: (iii) employs health care provider staff with exper- tise that includes, at a minimum, occupational medi- cine,
p.001709: environmental medicine, trauma-related psychi- atry and psychology, and social services counseling; and
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p.001709: (iv) meets such other requirements as specified by the Administrator.
p.001709: (B) CONTRACT REQUIREMENTS.—The WTC Program Administrator shall not enter into a contract with a Clin-
p.001709: ical Center of Excellence under subsection (a)(1) unless the Center agrees to do each of the following:
p.001709: (i) Establish a formal mechanism for consulting with and receiving input from representatives of eligi- ble
p.001709: populations receiving monitoring and treatment benefits under subtitle B from such Center.
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p.001729: screening-eligible WTC survivor under paragraph (1) or certi- fying any individual as a certified eligible WTC
p.001729: survivor under paragraph (2), the Administrator, in consultation with the Sec- retary of Homeland Security, shall
p.001729: determine whether the indi- vidual is on such list.
p.001729: (b) INITIAL HEALTH EVALUATION TO DETERMINE ELIGIBILITY FOR FOLLOWUP MONITORING OR TREATMENT.—
p.001729: (1) IN GENERAL.—In the case of a screening-eligible WTC survivor, the WTC Program shall provide for an
p.001729: initial health evaluation to determine if the survivor has a WTC-related health condition and is eligible
p.001729: for followup monitoring and
p.001729: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001731: 1731
p.001731: PUBLIC HEALTH SERVICE ACT
p.001731: Sec. 3322
p.001731:
p.001731: treatment benefits under the WTC Program. Initial health evaluation protocols under section
p.001731: 3305(a)(2)(A)(ii) shall be subject to approval by the WTC Program Administrator.
p.001731: (2) INITIAL HEALTH EVALUATION PROVIDERS.—The initial health evaluation described in paragraph (1) shall be
p.001731: provided through a Clinical Center of Excellence with respect to the in- dividual involved.
p.001731: (3) LIMITATION ON INITIAL HEALTH EVALUATION BENE- FITS.—Benefits for an initial health evaluation
p.001731: under this part for a screening-eligible WTC survivor shall consist only of a single medical initial health
p.001731: evaluation consistent with initial health evaluation protocols described in paragraph (1). Nothing in this
p.001731: paragraph shall be construed as preventing such an in- dividual from seeking additional medical initial health evalua-
p.001731: tions at the expense of the individual.
p.001731: SEC. 3322. ø42 U.S.C. 300mm–32¿ FOLLOWUP MONITORING AND TREAT- MENT OF CERTIFIED-ELIGIBLE WTC SURVIVORS
p.001731: FOR WTC-RELATED HEALTH CONDITIONS.
p.001731: (a) IN GENERAL.—Subject to subsection (b), the provisions of sections 3311 and 3312 shall apply to
p.001731: followup monitoring and treatment of WTC-related health conditions for certified-eligible WTC survivors in the
p.001731: same manner as such provisions apply to the monitoring and treatment of WTC-related health conditions for en- rolled
p.001731: WTC responders.
p.001731: (b) LIST OF WTC-RELATED HEALTH CONDITIONS FOR SUR- VIVORS.—The list of health conditions for
p.001731: screening-eligible WTC survivors and certified-eligible WTC survivors consists of the fol- lowing:
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p.001731: January 30, 2020
p.001731: (1) AERODIGESTIVE DISORDERS.—
p.001731: (A) Interstitial lung diseases.
p.001731: (B) Chronic respiratory disorder—fumes/vapors.
p.001731: (C) Asthma.
p.001731: (D) Reactive airways dysfunction syndrome (RADS).
p.001731: (E) WTC-exacerbated chronic obstructive pulmonary disease (COPD).
p.001731: (F) Chronic cough syndrome.
p.001731: (G) Upper airway hyperreactivity.
p.001731: (H) Chronic rhinosinusitis.
p.001731: (I) Chronic nasopharyngitis.
...

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p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
p.001341: (3) The term ‘‘treatment program’’ means a public or non- profit private program of treatment for
p.001341: dependence on heroin or other morphine-like drugs.
p.001341: TITLE XX—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
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p.001341: January 30, 2020
p.001341: FINDINGS AND PURPOSES
p.001341: SEC. 2001. ø300z¿ (a) The Congress finds that—
p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001341: January 30, 2020
p.001341:
p.001341: and are frequently associated with or are a cause of other trou- blesome situations in the family; and
p.001341: (B) such problems are best approached through a variety of integrated and essential services provided to
...

p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
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p.001341:
p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
...

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p.000283: Sec. 330E
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p.000283: January 30, 2020
p.000283: public or nonprofit private entities for the establishment and oper- ation of regional centers whose purpose is to
p.000283: develop, evaluate, and disseminate effective strategies, which utilize quality management measures, to assist
p.000283: public and private health care programs and providers in the appropriate utilization of preventive health
p.000283: care services by specific populations.
p.000283: (b) RESEARCH AND TRAINING.—The activities carried out by a center under subsection (a) may include
p.000283: establishing programs of research and training with respect to the purpose described in such subsection, including
p.000283: the development of curricula for training indi- viduals in implementing the strategies developed under such
p.000283: sub- section.
p.000283: (c) PRIORITY REGARDING INFANTS AND CHILDREN.—In carrying out the purpose described in subsection (a), the
p.000283: Secretary shall give priority to various populations of infants, young children, and their mothers.
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004.
p.000283: SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
p.000283: (a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
p.000283: (1) IN GENERAL.—The Secretary shall develop and imple- ment public health surveillance, education, research, and
p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
...

p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: 493
p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
p.000493:
...

p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
...

p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
...

p.000543: (C) research on the impact of domestic, dating and sexual violence, childhood exposure to such violence,
p.000543: and stalking on the health care system, health care utilization, health care costs, and health status; and
p.000543: (D) research on the impact of adverse childhood expe- riences on adult experience with domestic violence, dating
p.000543: violence, sexual assault, stalking, and adult health out- comes, including how to reduce or prevent the
p.000543: impact of adverse childhood experiences through the health care set- ting.
p.000543: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000543: $10,000,000 for each of fiscal years 2014 through 2018.
p.000543: (h) DEFINITIONS.—Except as otherwise provided herein, the definitions provided for in section 40002 of the
p.000543: Violence Against Women Act of 1994 shall apply to this section.
p.000543: SEC. 399Q. ø280g–4¿ PUBLIC AND HEALTH CARE PROVIDER EDU- CATION AND SUPPORT SERVICES.
p.000543: (a) IN GENERAL.—The Secretary, directly or through the awarding of grants to public or private nonprofit
p.000543: entities, may con- duct activities, which may include demonstration projects for the purpose of improving
p.000543: the provision of information on prematurity to health professionals and other health care providers and
p.000543: the public and improving the treatment and outcomes mothers of in- fants born preterm, and infants born
p.000543: preterm, as appropriate.
p.000543: (b) ACTIVITIES.—Activities to be carried out under subsection
p.000543: (a) may include the establishment of—
p.000543: (1) programs, including those to test and evaluate strate- gies, which, in collaboration with States,
p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: PUBLIC HEALTH SERVICE ACT
p.000545: Sec. 399R
p.000545:
p.000545:
p.000545:
p.000545: ery;
p.000545: (A) the core risk factors for preterm labor and deliv-
p.000545: (B) evidence-based strategies to prevent preterm birth
p.000545: and associated outcomes;
p.000545: (C) medically indicated deliveries before full term, and the risks of non-medically indicated deliveries before
p.000545: full term;
p.000545: (D) the importance of preconception and prenatal care, including—
p.000545: (i) smoking cessation;
p.000545: (ii) weight maintenance and good nutrition, in- cluding folic acid intake;
p.000545: (iii) the screening for and the treatment of infec- tions;
p.000545: (iv) screening for and treatment of substance use disorders;
...

p.000729: longitudinal study of environmental influences (including physical, chem- ical, biological, and psychosocial) on
p.000729: children’s health and development. Subsection (d) of such section requires periodic reports to the Congress
p.000729: regarding the study. The first report is required to be submitted not later than three years after the date
p.000729: of the enactment of the Public Law, which was enacted October 17, 2000.
p.000729: 32 The probable intent of the Congress is to refer to the ‘‘Eunice Kennedy Shriver National Institute of
p.000729: Child Health and Human Development’’. Section 1(b)(7) of Public Law 110–154 (121 Stat 1827) struck the term
p.000729: ‘‘National Institute of Child Health and Human Development’’ and inserted ‘‘Eunice Kennedy Shriver National
p.000729: Institute of Child Health and Human Development’’ each place such term appeared in the heading of subpart 7 of part C
p.000729: of title IV, but not in the text of section 448.
p.000729: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000729:
p.000729:
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p.000729: Sec. 449 PUBLIC HEALTH SERVICE ACT 730
p.000729:
p.000729: including prenatal development, population research, and special health problems and requirements of mothers and
p.000729: children.
p.000729: SUDDEN INFANT DEATH SYNDROME
p.000729: SEC. 449. ø285g–1¿ The Director of the Institute shall conduct and support research which specifically relates to
p.000729: sudden infant death syndrome.
p.000729: SEC. 450. ø285g–2¿ RESEARCH ON INTELLECTUAL DISABILITIES.
p.000729: The Director of the Institute shall conduct and support re- search and related activities into the causes,
p.000729: prevention, and treat- ment of intellectual disabilities.
p.000729: ASSOCIATE DIRECTOR FOR PREVENTION
p.000729: SEC. 451. ø285g–3¿ There shall be in the Institute an Associate Director for Prevention to coordinate and promote the
p.000729: programs in the Institute concerning the prevention of health problems of moth- ers and children. The Associate
p.000729: Director shall be appointed by the Director of the Institute from individuals who because of their pro- fessional
p.000729: training or experience are experts in public health or pre- ventive medicine.
p.000729:
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p.000729: January 30, 2020
p.000729: NATIONAL CENTER FOR MEDICAL REHABILITATION RESEARCH
p.000729: SEC. 452. ø285g–4¿ (a) There shall be in the Institute an agen- cy to be known as the National Center for
...

p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
...

p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
p.001501: (g) DEFINITIONS.—In this section:
p.001501: (1) The term ‘‘voluntary opt-out testing’’ means HIV/AIDS testing—
p.001501: (A) that is administered to an individual seeking other health care services; and
p.001501: (B) in which—
p.001501: (i) pre-test counseling is not required but the indi- vidual is informed that the individual will receive an
p.001501: HIV/AIDS test and the individual may opt out of such testing; and
p.001501: (ii) for those individuals with a positive test re- sult, post-test counseling (including referrals for
p.001501: care) is provided and confidentiality is protected.
p.001501: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001501:
p.001501:
p.001501:
p.001501:
p.001501:
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p.001503: (h) AUTHORIZATION OF APPROPRIATIONS.—Of the funds appro- priated annually to the Centers for Disease Control and
p.001503: Prevention for HIV/AIDS prevention activities, $30,000,000 shall be made available for each of the fiscal
p.001503: years 2007 through 2009 for grants under subsection (a), of which $20,000,000 shall be made available for grants to
p.001503: States with the policies described in subsection (b)(1), and $10,000,000 shall be made available for grants to
p.001503: States with the policies described in subsection (b)(2). Funds provided under this section are available until
p.001503: expended.
p.001503: SEC. 2626. ø300ff–34¿ PERINATAL TRANSMISSION OF HIV DISEASE; CON- TINGENT REQUIREMENT REGARDING STATE
p.001503: GRANTS UNDER THIS PART.
p.001503: (a) ANNUAL DETERMINATION OF REPORTED CASES.—A State shall annually determine the rate of reported
p.001503: cases of AIDS as a result of perinatal transmission among residents of the State.
p.001503: (b) CAUSES OF PERINATAL TRANSMISSION.—In determining the rate under subsection (a), a State shall also determine
p.001503: the possible causes of perinatal transmission. Such causes may include—
p.001503: (1) the inadequate provision within the State of prenatal counseling and testing in accordance with the
p.001503: guidelines issued by the Centers for Disease Control and Prevention;
p.001503: (2) the inadequate provision or utilization within the State of appropriate therapy or failure of such therapy
p.001503: to reduce perinatal transmission of HIV, including—
p.001503: (A) that therapy is not available, accessible or offered to mothers; or
p.001503: (B) that available therapy is offered but not accepted by mothers; or
p.001503: (3) other factors (which may include the lack of prenatal care) determined relevant by the State.
p.001503: (c) CDC REPORTING SYSTEM.—Not later than 4 months after the date of enactment of this subpart, the
p.001503: Director of the Centers for Disease Control and Prevention shall develop and implement a system to be used by
p.001503: States to comply with the requirements of subsections (a) and (b). The Director shall issue guidelines
p.001503: to en- sure that the data collected is statistically valid.
p.001503: SEC. 2627. ø300ff–37¿ STATE HIV TESTING PROGRAMS ESTABLISHED PRIOR TO OR AFTER ENACTMENT.
p.001503: Nothing in this subpart shall be construed to disqualify a State from receiving grants under this title if such State
p.001503: has established at any time prior to or after the date of enactment of this subpart a program of mandatory HIV testing.
p.001503: SEC. 2628. ø300ff–37a¿ RECOMMENDATIONS FOR REDUCING INCIDENCE OF PERINATAL TRANSMISSION.
p.001503: (a) STUDY BY INSTITUTE OF MEDICINE.—
p.001503: (1) IN GENERAL.—The Secretary shall request the Institute of Medicine to enter into an agreement with the
p.001503: Secretary
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001503:
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p.001503:
p.001503: Sec. 2631 PUBLIC HEALTH SERVICE ACT 1504
p.001503: under which such Institute conducts a study to provide the fol- lowing:
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p.001573: procedures re- garding referrals and obtaining prior authorization and providing services pursuant to a
p.001573: treatment plan (if any) approved by the plan or issuer.
p.001573: (B) OBSTETRICAL AND GYNECOLOGICAL CARE.—A group health plan or health insurance issuer described in para-
p.001573: graph (2) shall treat the provision of obstetrical and gyne- cological care, and the ordering of related
p.001573: obstetrical and gynecological items and services, pursuant to the direct ac- cess described under subparagraph
p.001573: (A), by a participating health care professional who specializes in obstetrics or gynecology as the
p.001573: authorization of the primary care pro- vider.
p.001573: (2) APPLICATION OF PARAGRAPH.—A group health plan, or health insurance issuer offering group or individual
p.001573: health in- surance coverage, described in this paragraph is a group health plan or coverage that—
p.001573: (A) provides coverage for obstetric or gynecologic care;
p.001573: and
p.001573: (B) requires the designation by a participant, bene-
p.001573: ficiary, or enrollee of a participating primary care provider.
p.001573: (3) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued to—
p.001573: (A) waive any exclusions of coverage under the terms and conditions of the plan or health insurance
p.001573: coverage with respect to coverage of obstetrical or gynecological care; or
p.001573: (B) preclude the group health plan or health insurance issuer involved from requiring that the obstetrical or gyne-
p.001573: cological provider notify the primary care health care pro- fessional or the plan or issuer of treatment decisions.
p.001573: SEC. 2725. 10 ø300gg–25¿ STANDARDS RELATING TO BENEFITS FOR MOTHERS AND NEWBORNS.
p.001573: (a) REQUIREMENTS FOR MINIMUM HOSPITAL STAY FOLLOWING BIRTH.—
p.001573: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001573: insurance cov- erage, may not—
p.001573: (A) except as provided in paragraph (2)—
p.001573: (i) restrict benefits for any hospital length of stay in connection with childbirth for the mother or new- born
p.001573: child, following a normal vaginal delivery, to less than 48 hours, or
p.001573: (ii) restrict benefits for any hospital length of stay in connection with childbirth for the mother or new-
p.001573: born child, following a cesarean section, to less than 96 hours, or
p.001573: (B) require that a provider obtain authorization from the plan or the issuer for prescribing any length of stay
p.001573: re-
p.001573:
p.001573:
p.001573:
p.001573:
p.001573:
p.001573: January 30, 2020
p.001573: 10 The placement of this section and succeeding sections 2726, 2727, and 2728 here, versus after section
p.001573: 2724, is ambiguous insofar as these sections at the time of their redesignation from sections 2704–2708 were not
p.001573: explicitly moved to follow section 2724, yet the failure to place them after section 2724 results in
p.001573: these sections not following ordinary sequential numbering.
p.001573: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001573:
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p.001573: Sec. 2725 PUBLIC HEALTH SERVICE ACT 1574
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p.001573: January 30, 2020
p.001573:
p.001573: quired under subparagraph (A) (without regard to para- graph (2)).
p.001573: (2) EXCEPTION.—Paragraph (1)(A) shall not apply in con- nection with any group health plan or health insurance
p.001573: issuer in any case in which the decision to discharge the mother or her newborn child prior to the
p.001573: expiration of the minimum length of stay otherwise required under paragraph (1)(A) is made by an attending
p.001573: provider in consultation with the moth- er.
p.001573: (b) PROHIBITIONS.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001573: insurance coverage, may not—
p.001573: (1) deny to the mother or her newborn child eligibility, or continued eligibility, to enroll or to
p.001573: renew coverage under the terms of the plan or coverage, solely for the purpose of avoiding the requirements of this
p.001573: section;
p.001573: (2) provide monetary payments or rebates to mothers to encourage such mothers to accept less than the minimum
p.001573: pro- tections available under this section;
p.001573: (3) penalize or otherwise reduce or limit the reimburse- ment of an attending provider because such
p.001573: provider provided care to an individual participant or beneficiary in accordance with this section;
p.001573: (4) provide incentives (monetary or otherwise) to an at- tending provider to induce such provider to provide
p.001573: care to an individual participant or beneficiary in a manner inconsistent with this section; or
p.001573: (5) subject to subsection (c)(3), restrict benefits for any por- tion of a period within a hospital length of stay
p.001573: required under subsection (a) in a manner which is less favorable than the benefits provided for any
p.001573: preceding portion of such stay.
p.001573: (c) RULES OF CONSTRUCTION.—
p.001573: (1) Nothing in this section shall be construed to require a mother who is a participant or beneficiary—
p.001573: (A) to give birth in a hospital; or
p.001573: (B) to stay in the hospital for a fixed period of time fol- lowing the birth of her child.
p.001573: (2) This section shall not apply with respect to any group health plan, or any health insurance issuer
p.001573: offering group or individual health insurance coverage, which does not provide benefits for hospital
p.001573: lengths of stay in connection with child- birth for a mother or her newborn child.
p.001573: (3) Nothing in this section shall be construed as preventing a group health plan or health insurance issuer
p.001573: from imposing deductibles, coinsurance, or other cost-sharing in relation to benefits for hospital lengths
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p.000415: 63 Section 3 of Public Law 100–578 provides that, with respect to subsection (g)(1) and sub- sections (h)
p.000415: through (m), any reference made in any of such subsections to the standards estab- lished under subsection (f)
p.000415: ‘‘shall be considered a reference to the standards established under subsection (d) [of section 353], as in
p.000415: effect on December 31, 1988.’’.
p.000415: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000415:
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p.000415:
p.000415: Sec. 353 PUBLIC HEALTH SERVICE ACT 416
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p.000415: January 30, 2020
p.000415:
p.000415: meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examina-
p.000415: tions and procedures within the laboratory, which quali- fications shall take into consideration
p.000415: competency, train- ing, experience, job performance, and education and which qualifications shall, as appropriate,
p.000415: be different on the basis of the type of examinations and procedures being performed by the laboratory
p.000415: and the risks and con- sequences of erroneous results associated with such exami- nations and procedures,
p.000415: (D) to qualify under a proficiency testing program meeting the standards established by the Secretary under
p.000415: paragraph (3), and
p.000415: (E) to meet such other requirements as the Secretary determines necessary to assure consistent performance
p.000415: by such laboratories of accurate and reliable laboratory ex- aminations and procedures.
p.000415: (2) CONSIDERATIONS.—In developing the standards to be issued under paragraph (1), the Secretary shall,
p.000415: within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration—
p.000415: (A) the examinations and procedures performed and the methodologies employed,
p.000415: (B) the degree of independent judgment involved,
p.000415: (C) the amount of interpretation involved,
p.000415: (D) the difficulty of the calculations involved,
p.000415: (E) the calibration and quality control requirements of the instruments used,
p.000415: (F) the type of training required to operate the instru- ments used in the methodology, and
p.000415: (G) such other factors as the Secretary considers rel- evant.
p.000415: (3) PROFICIENCY TESTING PROGRAM.—
p.000415: (A) IN GENERAL.—The Secretary shall establish stand- ards for the proficiency testing programs for laboratories
p.000415: issued a certificate under this section which are conducted by the Secretary, conducted by an organization
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p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
p.000495:
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
...

p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000503:
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
...

p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
...

p.000897: Families in Mental Health Crisis Reform Act of 2016, may adjust the target amount that an
p.000897: eligible entity may receive for a year through a grant or cooperative agreement under this section.
p.000897: (3) LIMITATION.—An eligible entity receiving funding under this section may not allocate more than 10 percent
p.000897: of funds awarded under this section to administrative functions, and the remaining amounts shall be
p.000897: allocated to health facilities that provide integrated care.
p.000897: (e) DURATION.—A grant or cooperative agreement under this section shall be for a period not to exceed 5 years.
p.000897: (f) REPORT ON PROGRAM OUTCOMES.—An eligible entity receiv- ing a grant or cooperative agreement under this section
p.000897: shall sub- mit an annual report to the Secretary that includes—
p.000897: (1) the progress made to reduce barriers to integrated care as described in the entity’s application under
p.000897: subsection (c); and
p.000897:
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p.000897: (2) a description of functional outcomes of special popu- lations, including—
p.000897: (A) with respect to adults with a serious mental ill- ness, participation in supportive housing or
p.000897: independent living programs, attendance in social and rehabilitative programs, participation in job training
p.000897: opportunities, satis- factory performance in work settings, attendance at sched- uled medical and mental health
p.000897: appointments, and compli- ance with prescribed medication regimes;
p.000897: (B) with respect to individuals with co-occurring men- tal illness and physical health conditions and chronic
p.000897: dis- eases, attendance at scheduled medical and mental health appointments, compliance with prescribed medication
p.000897: re- gimes, and participation in learning opportunities related to improved health and lifestyle practices; and
p.000897: (C) with respect to children and adolescents with a se- rious emotional disturbance who have co-occurring phys-
p.000897: ical health conditions and chronic diseases, attendance at scheduled medical and mental health
p.000897: appointments, com- pliance with prescribed medication regimes, and participa- tion in learning opportunities at school
p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000901: 901
p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
p.000901: transportation serv- ices, and habilitation and rehabilitation services, prevocational and
p.000901: vocational services, and housing serv- ices;
p.000901: (C) providing assistance to the eligible homeless indi- vidual in obtaining income support services,
p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
p.000901: benefits;
p.000901: (D) referring the eligible homeless individual for such other services as may be appropriate; and
p.000901: (E) providing representative payee services in accord- ance with section 1631(a)(2) of the Social Security
p.000901: Act if the eligible homeless individual is receiving aid under title XVI of such act and if the applicant is
p.000901: designated by the Secretary to provide such services;
p.000901: (8) supportive and supervisory services in residential set- tings;
p.000901: (9) referrals for primary health services, job training, edu- cational services, and relevant housing services;
p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
p.000901:
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p.000901: January 30, 2020
p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
...

p.000927: contribute to the appropriate treatment plan for the patient, and to monitor patient progress;
p.000927: (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders;
p.000927: (v) testing, as appropriate, for infections com- monly associated with illicit drug use;
p.000927: (vi) residential rehabilitation, and outpatient and intensive outpatient programs;
p.000927: (vii) recovery housing;
p.000927: (viii) community-based and peer recovery support services;
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000927:
p.000927:
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p.000927:
p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
p.000927:
p.000927:
p.000927:
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p.000927: January 30, 2020
p.000927:
p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
...

p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
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p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
p.000259: (B) recuperative care services;
p.000259: (C) environmental health services, including—
p.000259: (i) the detection and alleviation of unhealthful conditions associated with—
p.000259: (I) water supply;
p.000259: (II) chemical and pesticide exposures;
p.000259: (III) air quality; or
p.000259: (IV) exposure to lead;
p.000259: (ii) sewage treatment;
p.000259: (iii) solid waste disposal;
p.000259: (iv) rodent and parasitic infestation;
p.000259: (v) field sanitation;
p.000259: (vi) housing; and
p.000259: (vii) other environmental factors related to health;
p.000259:
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p.000259: January 30, 2020
p.000259: and
p.000259: (D) in the case of health centers receiving grants under subsection (g), special
p.000259: occupation-related health services for migratory and seasonal agricultural workers, including—
p.000259: (i) screening for and control of infectious diseases, including parasitic diseases; and
p.000259: (ii) injury prevention programs, including preven- tion of exposure to unsafe levels of agricultural chemi- cals
p.000259: including pesticides.
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000259:
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p.000259: Sec. 330 PUBLIC HEALTH SERVICE ACT 260
p.000259:
p.000259: (3) MEDICALLY UNDERSERVED POPULATIONS.—
p.000259: (A) IN GENERAL.—The term ‘‘medically underserved population’’ means the population of an urban or rural
p.000259: area designated by the Secretary as an area with a short- age of personal health services or a population group
p.000259: des- ignated by the Secretary as having a shortage of such serv- ices.
p.000259: (B) CRITERIA.—In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the
p.000259: spe- cific shortages of personal health services of an area or population group. Such criteria shall—
p.000259: (i) take into account comments received by the Secretary from the chief executive officer of a State and
p.000259: local officials in a State; and
p.000259: (ii) include factors indicative of the health status of a population group or residents of an area, the abil-
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p.000001: the Agency for Healthcare Research and Quality within the Service (formerly designated as the Agency for Health
p.000001: Care Policy and Research).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 3 PUBLIC HEALTH SERVICE ACT Sec. 203
p.000001:
p.000001: Bureau of Medical Services, and (4) the Bureau of State Services, and the Agency for Health Care Policy
p.000001: and Research. 2 The Sec- retary is authorized and directed to assign to the Office of the Sec- retary, to the
p.000001: National Institutes of Health, to the Bureau of Med- ical Services, and to the Bureau of State Services, respectively,
p.000001: the several functions of the Service, and to establish within them such divisions, sections and other units as he
p.000001: may find necessary; and from time to time, abolish, transfer, and consolidate divisions, sec- tions, and other
p.000001: units and assign their functions and personnel in such manner as he may find necessary for efficient operation
p.000001: of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated,
p.000001: except with the approval of the Secretary. The National Institutes of Health shall be adminis- tered as a
p.000001: part of the field service. The Secretary may delegate to any officer or employee of the Service such of his
p.000001: powers and duties under this Act, except the making of regulations, as he may deem necessary or expedient.
p.000001: SEC. 203. ø204¿ COMMISSIONED CORPS AND READY RESERVE CORPS.
p.000001: (a) ESTABLISHMENT.—
p.000001: (1) IN GENERAL.—There shall be in the Service a commis- sioned Regular Corps and a Ready Reserve Corps
p.000001: for service in time of national emergency.
p.000001: (2) REQUIREMENT.—All commissioned officers shall be citi- zens of the United States and shall be appointed
p.000001: without re- gard to the civil-service laws and compensated without regard to the Classification Act of 1923, 3
p.000001: as amended.
p.000001: (3) APPOINTMENT.—Commissioned officers of the Ready Re- serve Corps shall be appointed by the President and
p.000001: commis- sioned officers of the Regular Corps shall be appointed by the President.
p.000001: (4) ACTIVE DUTY.—Commissioned officers of the Ready Re- serve Corps shall at all times be subject to call to
p.000001: active duty by the Surgeon General, including active duty for the purpose of training.
p.000001: (5) WARRANT OFFICERS.—Warrant officers may be ap- pointed to the Service for the purpose of
p.000001: providing support to the health and delivery systems maintained by the Service and any warrant officer appointed
p.000001: to the Service shall be consid- ered for purposes of this Act and title 37, United States Code, to be a
p.000001: commissioned officer within the Commissioned Corps of the Service.
p.000001: (b) ASSIMILATING RESERVE CORP OFFICERS INTO THE REGULAR CORPS.—Effective on the date of enactment of the
p.000001: Patient Protec- tion and Affordable Care Act, all individuals classified as officers in the Reserve Corps
p.000001: under this section (as such section existed on the day before the date of enactment of such Act) and serving
p.000001: on
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: Although not established in this Act, the Centers for Disease Control and Prevention, the Health
p.000001: Resources and Services Administration, and the Agency for Toxic Substances and Dis- ease Registry are
p.000001: agencies of the Service.
p.000001: The Food and Drug Administration is also an agency of the Service.
p.000001: 2 So in law. See section 2008(g)(2) of Public Law 103–43 (107 Stat. 212). The term ‘‘the Agen- cy’’ probably should
p.000001: be preceded by ‘‘(5)’’, and the ‘‘and’’ before ‘‘(4)’’ probably should be struck. Further, Public Law
p.000001: 106–129 redesignated the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality
p.000001: (see 113 Stat. 1653).
p.000001: 3 Civil service and classification laws are now codified to title 5, United States Code.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: members of the Corps.
p.000001: (b) CORPS MANAGEMENT FOR DEPLOYMENT.—The Secretary shall—
p.000001: (1) organize members of the Corps into units for rapid de-
p.000001: ployment by the Secretary to respond to urgent or emergency public health care needs;
p.000001: (2) establish appropriate procedures for the command and control of units or individual members of the
p.000001: Corps that are deployed at the direction of the President or the Secretary in response to an urgent or
p.000001: emergency public health care need of national, State or local significance;
p.000001: (3) ensure that members of the Corps are trained, equipped and otherwise prepared to fulfill
p.000001: their public health and emergency response roles; and
p.000001: (4) ensure that deployment planning takes into account—
p.000001: (A) any deployment exemptions that may be granted by the Secretary based on the unique requirements of
p.000001: an agency and an individual’s functional role in such agency; and
p.000001:
p.000001:
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p.000001: January 30, 2020
p.000001: (B) the nature of the urgent or emergency public health care need.
p.000001: (c) DEPLOYMENT OF DETAILED OR ASSIGNED OFFICERS.—For purposes of pay, allowances, and benefits of a
p.000001: Commissioned Corps officer who is detailed or assigned to a Federal entity, the deploy- ment of such
p.000001: officer by the Secretary in response to an urgent or emergency public health care need shall be deemed
p.000001: to be an au- thorized activity of the Federal entity to which the officer is de- tailed or assigned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
p.000001: Sec. 204 PUBLIC HEALTH SERVICE ACT 6
p.000001: SURGEON GENERAL
p.000001: SEC. 204. ø205¿ The Surgeon General shall be appointed from the Regular Corps for a four-year term by the
p.000001: President by and with the advice and consent of the Senate. The Surgeon General shall be appointed from
p.000001: individuals who (1) are members of the Regular Corps, and (2) have specialized training or significant
p.000001: ex- perience in public health programs. Upon the expiration of such term, the Surgeon General, unless
p.000001: reappointed, shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he
p.000001: not served as Surgeon General.
p.000001:
p.000001:
p.000001:
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p.000001: January 30, 2020
p.000001:
p.000001: DEPUTY SURGEON GENERAL AND ASSISTANT SURGEONS GENERAL
p.000001: SEC. 205. ø206¿ (a) The Surgeon General shall assign one com- missioned officer from the Regular Corps to
p.000001: administer the Office of the Surgeon General, to act as Surgeon General during the ab- sence or disability
p.000001: of the Surgeon General or in the event of a va- cancy in that office, and to perform such other duties as
p.000001: the Sur- geon General may prescribe, and while so assigned he shall have the title of Deputy Surgeon
p.000001: General.
p.000001: (b) The Surgeon General shall assign eight commissioned offi- cers from the Regular Corps to be, respectively,
p.000001: the Director of the National Institutes of Health, the Chief of the Bureau of State Services, the Chief of
p.000001: the Bureau of Medical Services, the Chief Medical Officer of the United States Coast Guard, the Chief Dental
p.000001: Officer of the Service, the Chief Nurse Officer of the Service, the Chief Pharmacist Officer of the Service,
p.000001: and the Chief Sanitary En- gineering Officer of the Service, and while so serving they shall each have the
p.000001: title of Assistant Surgeon General.
p.000001: (c)(1) The Surgeon General, with the approval of the Secretary, is authorized to create special temporary
p.000001: positions in the grade of Assistant Surgeons General when necessary for the proper staffing of the Service. The
p.000001: Surgeon General may assign officers of either the Regular Corps or the Reserve Corps to any such temporary po-
p.000001: sition, and while so serving they shall each have the title of Assist- ant Surgeon General.
p.000001: (2) Except as provided in this paragraph, the number of special temporary positions created by the Surgeon
p.000001: General under para- graph (1) shall not on any day exceed 1 per centum of the highest number, during the ninety
p.000001: days preceding such day, of officers of the Regular Corps on active duty and officers of the Reserve Corps on
p.000001: active duty for more than thirty days. If on any day the number of such special temporary positions exceeds such 1 per
p.000001: centum limi- tations, for a period of not more than one year after such day, the number of such special temporary
p.000001: positions shall be reduced for purposes of complying with such 1 per centum limitation only by the
p.000001: resignation, retirement, death, or transfer to a position of a lower grade, of any officer holding any such
p.000001: temporary position.
p.000001: (d) The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in
p.000001: case of absence or disability, or vacancy in the offices, of both the Surgeon General and the Deputy
p.000001: Surgeon General.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 7 PUBLIC HEALTH SERVICE ACT Sec. 206
p.000001:
p.000001: GRADES, RANKS, AND TITLES OF THE COMMISSIONED CORPS
p.000001: SEC. 206. ø207¿ (a) The Surgeon General during the period of his appointment as such, shall be of the same grade as the
p.000001: Surgeon General of the army; the Deputy Surgeon General and the Chief Medical Officer of the United
p.000001: States Coast Guard, while assigned as such, shall have the grade corresponding with the grade of major
p.000001: general; and the Chief Dental Officer, while assigned as such, shall have the grade as is prescribed by
p.000001: law for the officer of the Dental Corps selected and appointed as Assistant Surgeon General of the Army.
p.000001: During the period of appointment to the posi- tion of Assistant Secretary for Health, a commissioned officer of the
p.000001: Public Health Service shall have the grade corresponding to the grade of General of the Army. Assistant
p.000001: Surgeons General, while assigned as such, shall have the grade corresponding with either the grade of
p.000001: brigadier general or the grade of major general, as may be determined by the Secretary after considering
p.000001: the impor- tance of the duties to be performed: Provided, That the number of Assistant Surgeons General having a
p.000001: grade higher than that cor- responding to the grade of brigadier general shall at no time exceed one-half of the
p.000001: number of positions created by subsection (b) of sec- tion 205 or pursuant to subsection (c) of such section.
p.000001: The grades of commissioned officers of the Service shall correspond with grades of officers of the Army as follows:
p.000001: (1) Officers of the director grade—colonel;
p.000001: (2) Officers of the senior grade—lieutenant colonel;
p.000001: (3) Officers of the full grade—major;
p.000001: (4) Officers of the senior assistant grade—captain;
p.000001: (5) Officers of the assistant grade—first lieutenant;
p.000001: (6) Officers of the junior assistant grade—second lieuten-
p.000001: ant;
p.000001: (7) Chief warrant officers of (W–4) grade—chief warrant of-
p.000001: ficer (W–4);
p.000001: (8) Chief warrant officers of (W–3) grade—chief warrant of- ficer (W–3);
p.000001: (9) Chief warrant officers of (W–2) grade—chief warrant of- ficer (W–2); and
p.000001: (10) Warrant officers of (W–1) grade—warrant officer (W–
p.000001:
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p.000001: January 30, 2020
p.000001: 1).
p.000001: (b) The titles of medical officers of the foregoing grades shall be respectively (1) medical director, (2)
p.000001: senior surgeon, (3) surgeon,
p.000001: (4) senior assistant surgeon, (5) assistant surgeon and (6) junior as- sistant surgeon.
p.000001: (c) The President is authorized to prescribe titles, appropriate to the several grades, for commissioned
p.000001: officers of the Service other than medical officers. All titles of the officers of the Reserve Corps shall have the
p.000001: suffix ‘‘Reserve’’.
p.000001: (d) Within the total number of officers of the Regular Corps au- thorized by the appropriation Act or Acts for each
p.000001: fiscal year to be on active duty, the Secretary shall by regulation prescribe the max- imum number of officers
p.000001: authorized to be in each of the grades from the warrant officer (W–1) grade to the director grade,
p.000001: inclu- sive. Such numbers shall be determined after considering the an- ticipated needs of the Service
p.000001: during the fiscal year, the funds
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 207 PUBLIC HEALTH SERVICE ACT 8
p.000001:
p.000001: available, the number of officers in each grade at the beginning of the fiscal year, and the anticipated
p.000001: appointments, the anticipated promotions based on years of service, and the anticipated retire- ments
p.000001: during the fiscal year. The number so determined for any grade for a fiscal year may not exceed the
p.000001: number limitation (if any) contained in the appropriation Act or Acts for such year. Such regulations for each
p.000001: fiscal year shall be prescribed as promptly as possible after the appropriation Act fixing the authorized
p.000001: strength of the corps for that year, and shall be subject to amendment only if such authorized strength or such number
p.000001: limitation is thereafter changed. The maxima established by such regulations shall not re- quire (apart from action
p.000001: pursuant to other provisions of this Act) any officer to be separated from the Service or reduced in
p.000001: grade.
p.000001: (e) In computing the maximum number of commissioned offi- cers of the Public Health Service authorized by law
p.000001: to hold a grade which corresponds to the grade of brigadier general or major gen- eral, there may be excluded
p.000001: from such computation not more than three officers who hold such a grade so long as such officers are as- signed to
p.000001: duty and are serving in a policymaking position in the Department of Defense.
p.000001: (f) In computing the maximum number of commissioned offi- cers of the Public Health Service authorized by law
p.000001: or administra- tive determination to serve on active duty, there may be excluded from such computation
p.000001: officers who are assigned to duty in the De- partment of Defense.
p.000001:
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p.000001: January 30, 2020
p.000001: APPOINTMENT OF PERSONNEL
p.000001: SEC. 207. ø209¿ (a)(1) Except as provided in subsections (b) and (e) of this section, original appointments to
p.000001: the Regular Corps may be made only in the warrant officer (W–1), chief warrant offi- cer (W–2), chief warrant officer
p.000001: (W–3), chief warrant officer (W–4), junior assistant, assistant, and senior assistant grades and original appointments
p.000001: to a grade above junior assistant shall be made only after passage of an examination, given in accordance with
p.000001: regula- tions of the President, in one or more of the several branches of medicine, dentistry, hygiene,
p.000001: sanitary engineering, pharmacy, psy- chology, nursing, or related scientific specialties in the field of pub- lic
p.000001: health.
p.000001: (2) Original appointments to the Reserve Corps may be made to any grade up to and including the director grade
p.000001: but only after passage of an examination given in accordance with regulations of the President. Reserve commissions
p.000001: shall be for an indefinite pe- riod and may be terminated at any time, as the President may di- rect.
p.000001: (3) No individual who has attained the age of forty-four shall be appointed to the Regular Corps, or
p.000001: called to active duty in the Reserve Corps for a period in excess of one year, unless (A) he has had a number
p.000001: of years of active service (as defined in section 211(d)) equal to the number of years by which his
p.000001: age exceeds forty-four, or (B) the Surgeon General determines that he possesses exceptional qualifications, not
p.000001: readily available elsewhere in the Commissioned Corps of the Public Health Service, for the perform- ance of
p.000001: special duties with the Service, or (C) in the case of an offi-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001:
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p.000001:
p.000001: Sec. 207 PUBLIC HEALTH SERVICE ACT 10
p.000001:
p.000001: credit provided in paragraph (1), be credited with the service for which he is entitled to credit under
p.000001: any other provision of law if such service exceeds that to which he would be entitled under such paragraph.
p.000001: (3) For purposes of promotion, any person originally appointed in the Regular Corps to the senior assistant
p.000001: grade or above who has had active service in the Reserve Corps shall be considered as having had on the date of
p.000001: appointment the length of service pro- vided for in paragraph (1), plus whichever of the following is great- er:
p.000001: (A) The excess of his total active service in the Reserve Corps (above the grade of junior assistant) over
p.000001: the length of service pro- vided in such paragraph, to the extent that such excess is on ac- count of
p.000001: service in the Reserve Corps in or above the grade to which he is appointed in the Regular Corps or (B) his
p.000001: active service in the same or any higher grade in the Reserve Corps after the first day on which, under
p.000001: regulations in effect on the date of his appointment to the Regular Corps, he would have had the training and
p.000001: experience necessary for such appointment.
p.000001: (4) For purposes of promotion, any person whose original ap- pointment is to the assistant grade in the
p.000001: Regular Corps shall be considered as having had on the date of appointment service equal to his total active
p.000001: service in the Reserve Corps in and above the assistant grade.
p.000001: (e)(1) A former officer of the Regular Corps may, if application for appointment is made within two years after the
p.000001: date of the ter- mination of his prior commission in the Regular Corps, be re- appointed to the Regular Corps
p.000001: without examination, except as the Surgeon General may otherwise prescribe, and without regard to the numerical
p.000001: limitations of subsection (b).
p.000001: (2) Reappointments pursuant to this subsection may be made to the permanent grade held by the former
p.000001: officer at the time of the termination of his prior commission, or to the next higher grade if such
p.000001: officer meets the eligibility requirements prescribed by regulation for original appointment to such higher
p.000001: grade. For purposes of pay, promotion, and seniority in grade, such re- appointed officer shall
p.000001: receive the credits for service to which he would be entitled if such appointment were an original
p.000001: appoint- ment, but in no event less than the credits he held at the time his prior commission was terminated,
p.000001: except that if such officer is re- appointed to the next higher grade he shall receive no credit for se- niority
p.000001: in grade.
p.000001: (3) No former officer shall be reappointed pursuant to this sub- section unless he shall meet such standards as
p.000001: the Secretary may prescribe.
p.000001: (f) In accordance with regulations, special consultants may be employed to assist and advise in the operations
p.000001: of the Service. Such consultants may be appointed without regard to the civil-service laws and their
p.000001: compensation may be fixed without regard to the Classification Act of 1923, as amended. 4
p.000001: (g) In accordance with regulations, individual scientists, other than commissioned officers of the Service,
p.000001: may be designated by the Surgeon General to receive fellowships, appointed for duty with
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 4 See footnote for the second sentence of section 203.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 11 PUBLIC HEALTH SERVICE ACT Sec. 208
p.000001:
p.000001: the Service without regard to the civil-service laws and com- pensated without regard to the
p.000001: Classification Act of 1923, as amended, 4 may hold their fellowships under conditions prescribed
p.000001: therein, and may be assigned for studies or investigations either in this country or abroad during the terms of their
p.000001: fellowships.
p.000001: (h) Persons who are not citizens may be employed as consult- ants pursuant to subsection (e) and may
p.000001: be appointed to fellow- ships pursuant to subsection (f). Unless otherwise specifically pro- vided, any
p.000001: prohibition in any other Act against the employment of aliens, or against the payment of compensation to them,
p.000001: shall not be applicable in the case of persons employed or appointed pursu- ant to such subsections.
p.000001: (i) The appointment of any officer or employee of the Service made in accordance with the civil-service laws
p.000001: shall be made by the Secretary, and may be made effective as of the date on which such officer or employee enters upon
p.000001: duty.
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p.000001: January 30, 2020
p.000001:
p.000001: PAY AND ALLOWANCES
p.000001: SEC. 208. ø210¿ (a)(1) Commissioned officers of the Regular and Reserve Corps shall be entitled to receive such
p.000001: pay and allow- ances as are now or may hereafter be authorized by law.
p.000001: (2) For provisions relating to the receipt of special pay by com- missioned officers of the Regular and Reserve Corps
p.000001: while on active duty, see section 303a(b) or 373 of title 37, United States Code.
p.000001: (b) Commissioned officers on active duty, and retired officers entitled to retired pay pursuant to section
p.000001: 210(g)(3), section 211 or section 221(a), shall be permitted to purchase supplies from the Army, Navy, Air
p.000001: Force, and Marine Corps at the same price as is charged officers thereof.
p.000001: (c) Members of the National Advisory Health Council and members of other national advisory or review
p.000001: councils or commit- tees established under this Act, including members of the Technical Electronic Product Radiation
p.000001: Safety Standards Committee and the Board of Regents of the National Library of Medicine, but exclud- ing ex
p.000001: officio members, while attending conferences or meetings of their respective councils or committees or while
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p.000001: to this subsection shall be included in the classified civil service of the United States, but appointments to
p.000001: such positions shall be made without competitive examination upon approval of the pro- posed appointee’s
p.000001: qualifications by the Civil Service Commission or such officers or agents as it may designate for this purpose.
p.000001:
p.000001: PROFESSIONAL CATEGORIES
p.000001: SEC. 209. ø210b¿ (a) For the purpose of establishing eligibility of officers of the Regular Corps for
p.000001: promotions, the Surgeon Gen- eral shall by regulation divide the corps into professional cat- egories.
p.000001: Each category shall, as far as practicable, be based upon one of the subjects of examination set forth
p.000001: in section 207(a)(1) or upon a subdivision of such subject, and the categories shall be de- signed to group
p.000001: officers by fields of training in such manner that officers in any one grade in any one category will
p.000001: be available for
p.000001:
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p.000001: January 30, 2020
p.000001: 5 See footnote for the second sentence of section 203.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 13 PUBLIC HEALTH SERVICE ACT Sec. 210
p.000001:
p.000001: similar duty in the discharge of the several functions of the Serv- ice.
p.000001: (b) Each officer of the Regular Corps on active duty shall, on the basis of his training and
p.000001: experience, be assigned by the Sur- geon General to one of the categories established by regulations
p.000001: under subsection (a). Except upon amendment of such regulations, no assignment so made shall be changed unless
p.000001: the Surgeon Gen- eral finds (1) that the original assignment was erroneous, or (2) that the officer is
p.000001: equally well qualified to serve in another cat- egory to which he has requested to be transferred, and
p.000001: that such transfer is in the interests of the Service.
p.000001: (c) Within the limits fixed by the Secretary in regulations under section 206(d) for any fiscal year, the
p.000001: Surgeon General shall determine for each category in the Regular Corps the maximum number of officers
p.000001: authorized to be in each of the grades from the warrant officer (W–1) grade to the director grade, inclusive.
p.000001: (d) The excess of the number so fixed for any grade in any cat- egory over the number of officers of the
p.000001: Regular Corps on active duty in such grade in such category (including, in the case of the director
p.000001: grade, officers holding such grade in accordance with sec- tion 206(c)) shall for the purpose of promotions
p.000001: constitute vacancies in such grade in such category. For purposes of this subsection, an officer who has been
p.000001: temporarily promoted or who is temporarily holding the grade of director in accordance with section 206(c) shall
p.000001: be deemed to hold the grade to which so promoted or which he is temporarily holding; but while he
p.000001: holds such promotion or grade, and while any officer is temporarily assigned to a position pursuant to section
p.000001: 205(c), the number fixed under subsection (c) of this sec- tion for the grade of his permanent rank shall be
p.000001: reduced by one.
p.000001: (e) The absence of a vacancy in a grade in a category shall not prevent an appointment to such grade pursuant to
p.000001: section 207, a permanent length of service promotion, or the recall of a retired of- ficer to active duty; but
p.000001: the making of such an appointment, pro- motion, or recall shall be deemed to fill a vacancy if one exists.
p.000001: (f) Whenever a vacancy exists in any grade in a category the Surgeon General may increase by one the
p.000001: number fixed by him under subsection (c) for the next lower grade in the same category, without regard to the
p.000001: numbers fixed in regulations under section 206(d); and in that event the vacancy in the higher grade shall not be
p.000001: filled except by a permanent promotion, and upon the making of such promotion the number for the next lower
p.000001: grade shall be re- duced by one.
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p.000001: January 30, 2020
p.000001:
p.000001: PROMOTIONS AND SEPARATION OF COMMISSIONED OFFICERS IN THE REGULAR CORPS
p.000001: SEC. 210. ø211¿ (a) Promotions of officers of the Regular Corps to any grade up to and including the director grade
p.000001: shall be either permanent promotions based on length of service, other permanent promotions to fill vacancies, or
p.000001: temporary promotions. Permanent promotions shall be made by the President, and temporary pro- motions shall
p.000001: be made by the President. Each permanent pro- motion shall be to the next higher grade, and shall be
p.000001: made only
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p.000001: senior grade, or to both the full grade and the senior grade, shall be made only if there are vacancies in
p.000001: such grade. A grade in any category with re- spect to which such regulations have been issued is referred to
p.000001: in this section as a ‘‘restricted grade’’.
p.000001: (c) Examinations to determine qualification for permanent pro- motions may be either noncompetitive or
p.000001: competitive, as the Sur- geon General shall in each case determine; except that examina- tions for
p.000001: promotions to the assistant or senior assistant grade shall in all cases be noncompetitive. The officers to be examined
p.000001: shall be selected by the Surgeon General from the professional category, and in the order of seniority in
p.000001: the grade, from which promotion is to be recommended. In the case of a competitive examination the Surgeon
p.000001: General shall determine in advance of the examination the number (which may be one or more) of officers who,
p.000001: after pass- ing the examination, will be recommended to the President for pro- motion; but if the examination is
p.000001: one for promotions based on length of service, or is one for promotions to fill vacancies other than
p.000001: vacancies in the director grade or in a restricted grade, such number shall not be less than 80 per centum of
p.000001: the number of offi- cers to be examined.
p.000001: (d) Officers of the Regular Corps, found pursuant to subsection
p.000001: (c) to be qualified, shall be given permanent promotions based on length of service, as follows:
p.000001: (1) Officers in the warrant officer (W–1) grade, chief warrant officer (W–2) grade, chief warrant officer
p.000001: (W–3) grade, chief war- rant officer (W–4) grade, and junior assistant grade shall be pro- moted at
p.000001: such times as may be prescribed in regulations of the President.
p.000001: (2) Officers with permanent rank in the assistant grade, the senior assistant grade, and the full grade shall
p.000001: (except as provided in regulations under subsection (b)) be promoted after completion of three, ten, and
p.000001: seventeen years, respectively, of service in grades above the junior assistant grade; and such promotions, when made,
p.000001: shall be effective, for purposes of pay and seniority in grade, as of the day following the completion of such years of
p.000001: service. An officer with permanent rank in the assistant, senior assistant, or full grade who has not
p.000001: completed such years of service shall be pro- moted at the same time, and his promotion shall be effective as of
p.000001: the same day, as any officer junior to him in the same grade in the same professional category who is promoted under
p.000001: this paragraph.
p.000001: (e) Officers in a professional category of the Regular Corps, found pursuant to subsection (c) to be
p.000001: qualified may be given per- manent promotions to fill any or all vacancies in such category in the
p.000001: senior assistant grade, the full grade, the senior grade, or the director grade; but no officer who has
p.000001: not had one year of service with permanent or temporary rank in the next lower grade shall be promoted
p.000001: to any restricted grade or to the director grade.
p.000001: (f) If an officer who has completed the years of service required for promotion to a grade under paragraph (2) of
p.000001: subsection (d) fails to receive such promotion, he shall (unless he has already been
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 15 PUBLIC HEALTH SERVICE ACT Sec. 210
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p.000001: January 30, 2020
p.000001: twice examined for promotion to such grade) be once reexamined for promotion to such grade. If he is thereupon
p.000001: promoted (otherwise than under subsection (e)), the effective date of such promotion shall be one year later
p.000001: than it would have been but for such failure. Upon the effective date of any permanent promotion of such officer to
p.000001: such grade, he shall be considered as having had only the length of service required for such promotion which he
p.000001: previously failed to receive.
p.000001: (g) If, for reasons other than physical disability, an officer of the Regular Corps in the warrant officer
p.000001: (W–1) grade or junior as- sistant grade is found pursuant to subsection (c) not to be qualified for promotion he shall
p.000001: be separated from the Service. If, for reasons other than physical disability, an officer of the Regular Corps
p.000001: in the chief warrant officer (W–2), chief warrant officer (W–3), assist- ant, senior assistant, or full grade,
p.000001: after having been twice exam- ined for promotion (other than promotion to a restricted grade), fails to be
p.000001: promoted—
p.000001: (1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the Service and paid
p.000001: six months’ basic pay and allowances;
p.000001: (2) if in the chief warrant officer (W–3) or senior assistant grade he shall be separated from the Service and
p.000001: paid one year’s basic pay and allowances;
p.000001: (3) if in the full grade he shall be considered as not in line for promotion and shall, at such time thereafter as the
p.000001: Surgeon General may determine, be retired from the Service with re- tired pay (unless he is entitled to
p.000001: a greater amount by reason of another provision of law)—
p.000001: (A) in the case of an officer who first became a mem- ber of a uniformed service before September 8, 1980,
p.000001: at the rate of 21⁄2 percent of the retired pay base determined under section 1406(h) of title 10, United
p.000001: States Code, for each year, not in excess of 30, of his active commissioned service in the Service; or
p.000001: (B) in the case of an officer who first became a mem- ber of a uniformed service on or after
p.000001: September 8, 1980, at the rate determined by multiplying—
p.000001: (i) the retired pay base determined under section 1407 of title 10, United States Code; by
p.000001: (ii) the retired pay multiplier determined under section 1409 of such title for the number of years of
p.000001: his active commissioned service in the Service.
p.000001: (h) If an officer of the Regular Corps, eligible to take an exam- ination for promotion, refuses to take such
p.000001: examination, he may be separated from the Service in accordance with regulations of the President.
p.000001: (i) At the end of his first three years of service, the record of each officer of the Regular Corps,
p.000001: originally appointed to the senior assistant grade or above, shall be reviewed in accordance with reg- ulations of
p.000001: the President and, if found not qualified for further service, he shall be separated from the
p.000001: Service and paid six months’ pay and allowances.
p.000001: (j)(1) The order of seniority of officers in a grade in the Regular Corps shall be determined, subject to the
p.000001: provisions of paragraph
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 210 PUBLIC HEALTH SERVICE ACT 16
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p.000001: January 30, 2020
p.000001:
p.000001: (2), by the relative length of time spent in active service after the effective date of each such officer’s
p.000001: original appointment or perma- nent promotion in that grade. When permanent promotions of two or more officers to
p.000001: the same grade are effective on the same day, their relative seniority shall be the same as it was in
p.000001: the grade from which promoted. In all other cases of original appointments or permanent promotions (or
p.000001: both) to the same grade effective on the same day, relative seniority shall be determined in accordance with
p.000001: regulations of the President.
p.000001: (2) In the case of an officer originally appointed in the Regular Corps to the grade of assistant or above, his
p.000001: seniority in the grade to which appointed shall be determined after inclusion, as service in such grade, of
p.000001: any active service in such grade or in any higher grade in the Reserve Corps, but (if the appointment is to the grade
p.000001: of senior assistant or above) only to the extent of whichever of the following is greater: (A) His active service
p.000001: in such grade or any higher grade in the Reserve Corps after the first day on which, under regulations
p.000001: in effect on the date of his appointment to the Regular Corps, he had the training and experience
p.000001: necessary for such appointment, or (B) the excess of his total active service in the Reserve Corps (above the
p.000001: grade of junior assistant) over three years if his appointment in the Regular Corps is to the senior
p.000001: as- sistant grade, over ten years if the appointment is to the full grade, or over seventeen years if the
p.000001: appointment is to the senior grade.
p.000001: (k) Any commissioned officer of the Regular Corps in any grade
p.000001: in any professional category may be recommended to the President for temporary promotion to fill a vacancy in
p.000001: any higher grade in such category, up to and including the director grade. In time of war, or of
p.000001: national emergency proclaimed by the President, any commissioned officer of the Regular Corps in any grade in any
p.000001: pro- fessional category may be recommended to the President for pro- motion to any higher grade in such
p.000001: category, up to and including the director grade, whether or not a vacancy exists in such grade. The
p.000001: selection of officers to be recommended for temporary pro- motions shall be made in accordance with regulations
p.000001: of the Presi- dent. Promotion of an officer recommended pursuant to this sub- section may be made without
p.000001: regard to length of service, without examination, and without vacating his permanent appointment, and shall
p.000001: carry with it the pay and allowances of the grade to which promoted. Such promotions may be terminated at
p.000001: any time, as may be directed by the President.
p.000001: (l) Whenever the number of officers of the Regular Corps on ac- tive duty, plus the number of officers of the
p.000001: Reserve Corps who have been on active duty for thirty days or more, exceeds the au- thorized strength
p.000001: of the Regular Corps, the Secretary shall deter- mine the requirements of the Service in each grade in
p.000001: each cat- egory, based upon the total number of officers so serving on active duty and the tasks being performed
p.000001: by the Service; and the Sur- geon General shall thereupon assign each officer of the Reserve Corps on
p.000001: active duty to a professional category. If the Secretary finds that the number of officers fixed under section
p.000001: 209(c) for any grade and category (or the number of officers, including officers of the Reserve Corps, on
p.000001: active duty in such grade in such category, if such number is greater than the number fixed under
p.000001: section
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 17 PUBLIC HEALTH SERVICE ACT Sec. 211
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p.000001: 209(c)) is insufficient to meet such requirements of the Service, offi- cers of either the Regular Corps or the Reserve
p.000001: Corps may be rec- ommended for temporary promotion to such grade in such category. Any such promotion may be terminated
p.000001: at any time, as may be di- rected by the President.
p.000001: (m) Any officer of the Regular Corps, or any officer of the Re- serve Corps on active duty, who is
p.000001: promoted to a higher grade shall, unless he expressly declines such promotion, be deemed for all purposes
p.000001: to have accepted such promotion; and shall not be re- quired to renew his oath of office, or to execute a new affidavit
p.000001: as required by the Act of December 11, 1926, as amended (5 U.S.C. 21a). 6
p.000001: RETIREMENT OF COMMISSIONED OFFICERS
p.000001: SEC. 211. ø212¿ (a)(1) A commissioned officer of the Service shall, if he applies for retirement, be
p.000001: retired on or after the first day of the month following the month in which he attains the age of sixty-four
p.000001: years. This paragraph does not permit or require the involuntary retirement of any individual because of
p.000001: the age of the individual.
p.000001: (2) A commissioned officer of the Service may be retired by the Secretary, and shall be retired if he applies
p.000001: for retirement, on the first day of any month after completion of thirty years of active service.
p.000001: (3) Any commissioned officer of the Service who has had less than thirty years of active service may be
p.000001: retired by the Secretary, with or without application by the officer, on the first day of any month after
p.000001: completion of twenty or more years of active service of which not less than ten are years of active
p.000001: commissioned service in any of the uniformed services.
p.000001: (4) Except as provided in paragraph (6), a commissioned officer retired pursuant to paragraph (1), (2), or (3)
p.000001: who was (in the case of an officer in the Reserve Corps) on active duty with the Service on the day preceding
p.000001: such retirement shall be entitled to receive retired pay calculated by multiplying the retired pay base
p.000001: deter- mined under section 1406 of title 10, United States Code, by the retired pay multiplier determined
p.000001: under section 1409 of such title for the numbers of years of service credited to the officer under this paragraph
p.000001: and in which, in the case of a temporary promotion to such grade, he has performed active duty for
p.000001: not less than six months, (A) for each year of active service, or (B) if it results in higher retired
p.000001: pay, for each of the following years:
p.000001: (i) his years of active service (determined without regard to subsection (d)) as a member of a uniformed
p.000001: service; plus
p.000001: (ii) in the case of a medical or dental officer, four years and, in the case of a medical officer,
p.000001: who has completed one year of medical internship or the equivalent thereof, one addi- tional year, the four
p.000001: years and the one year to be reduced by the period of active service performed during such officer’s
p.000001: at- tendance at medical school or dental school or during his med- ical internship; plus
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 6 That Act has been codified to section 3332 of title 5, United States Code.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 211 PUBLIC HEALTH SERVICE ACT 18
p.000001:
p.000001: (iii) the number of years of service with which he was enti- tled to be credited for purposes of basic pay on
p.000001: May 31, 1958, or (if higher) on any date prior thereto, reduced by any such year included under clause (i)
p.000001: and further reduced by any such year with which he was entitled to be credited under para- graphs (7) and
p.000001: (8) of section 205(a) of title 37, United States Code, on any date before June 1, 1958;
p.000001: except that (C) in the case of any officer whose retired pay, so com- puted, is less than 50 per centum of such
p.000001: basic pay, who retires pursuant to paragraph (1) of this subsection, who has not less than twelve whole years of
p.000001: active service (computed without the applica- tion of subsection (e)), and who does not use, for purposes of
p.000001: a re- tirement annuity under the Civil Service Retirement Act, any serv- ice which is also creditable in
p.000001: computing his retired pay from the Service, it shall, instead, be 50 per centum of such pay, (D) the re- tired pay
p.000001: of an officer shall in no case be more than 75 per centum of such basic pay, and (E) in the case of any
p.000001: officer who partici- pates in the modernized retirement system by reason of section 1409(b) of title 10,
p.000001: United States Code (including pursuant to an election under subparagraph (B) of that section), subparagraph (C)
p.000001: shall be applied by substituting ‘‘40 per centum’’ for ‘‘50 per cen- tum’’ each place the term appears.
p.000001: (5) With the approval of the President, a commissioned officer whose service as Surgeon General, Deputy
p.000001: Surgeon General, or As- sistant Surgeon General has totaled four years or more and who has had not less
p.000001: than twenty-five years of active service in the Service may retire voluntarily at any time; and except as
p.000001: provided in paragraph (6), his retired pay shall be at the rate of 75 per cen- tum of the basic pay of the highest
p.000001: grade held by him as such offi- cer.
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p.000001: January 30, 2020
p.000001: (6) The retired pay of a commissioned officer retired under this
p.000001: subsection who first became a member of a uniformed service after September 7, 1980, is determined by multiplying—
p.000001: (A) the retired pay base determined under section 1407 of title 10, United States Code; by
p.000001: (B) the retired pay multiplier determined under section 1409 of such title for the number of years of
p.000001: service credited to the officer under paragraph (4).
p.000001: (7) Retired pay computed under section 210(g)(3) or under paragraph (4) or (5) of this subsection, if not a
p.000001: multiple of $1, shall be rounded to the next lower multiple of $1.
p.000001: (b) For purposes of subsection (a), the basic pay of the highest grade to which a commissioned officer has
p.000001: received a temporary promotion means the basic pay to which he would be entitled if serving on active duty
p.000001: in such grade on the date of his retirement.
p.000001: (c) A commissioned officer, retired for reasons other than for failure of promotion to the senior grade, may
p.000001: (1) if an officer of the Regular Corps or an officer of the Reserve Corps entitled to retired pay under subsection
p.000001: (a), be involuntarily recalled to active duty during such times as the Commissioned Corps constitutes a branch of
p.000001: the land or naval forces of the United States, and (2) if an officer of either the Regular or Reserve Corps, be
p.000001: recalled to active duty at any time with his consent.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 19 PUBLIC HEALTH SERVICE ACT Sec. 212
p.000001:
p.000001: (d) The term ‘‘active service’’, as used in subsection (a), in- cludes:
p.000001: (1) all active service in any of the uniformed services;
p.000001: (2) active service with the Public Health Service, other than as a commissioned officer, which the Surgeon
p.000001: General de- termines is comparable to service performed by commissioned officers of the Service, except that, if
p.000001: there are more than five years of such service only the last five years thereof may be in- cluded;
p.000001: (3) all active service (other than service included under the preceding provisions of this subsection) which is
p.000001: creditable for retirement purposes under laws governing the retirement of members of any of the uniformed
p.000001: services; and
p.000001: (4) service performed as a member of the Senior Bio- medical Research Service established by section
p.000001: 228, except that, if there are more than 5 years of such service, only the last 5 years thereof may be
p.000001: included.
p.000001: (e) For the purpose of determining the number of years by which a percentage of the basic pay of an officer
p.000001: is to be multiplied in computing the amount of his retired pay pursuant to section 210(g)(3) or paragraph (4)
p.000001: of subsection (a) of this section, each full month of service that is in addition to the number of full
p.000001: years of service credited to an officer is counted as one-twelfth of a year and any remaining fractional part of a
p.000001: month is disregarded.
p.000001: (f) For purposes of retirement or separation for physical dis- ability under chapter 61 of title 10, United
p.000001: States Code, a commis- sioned officer of the Service shall be credited, in addition to the service described
p.000001: in section 1208(a)(2) of that title, with active serv- ice with the Public Health Service, other than as a
p.000001: commissioned officer, which the Surgeon General determines is comparable to service performed by
p.000001: commissioned officers of the Service, except that, if there are more than five years of such service, only the
p.000001: last five years thereof may be so credited. For such purposes, such sec- tion 1208(a)(2) shall be applicable to
p.000001: officers of the Regular or Re- serve Corps of the Service.
p.000001:
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p.000001: January 30, 2020
p.000001: MILITARY BENEFITS
p.000001: SEC. 212. ø213¿ (a) Except as provided in subsection (b), com- missioned officers of the Service and their
p.000001: surviving beneficiaries shall, with respect to active service performed by such officers—
p.000001: (1) in time of war;
p.000001: (2) on detail for duty with the Army, Navy, Air Force, Ma- rine Corps, or Coast Guard; or
p.000001: (3) while the Service is part of the military forces of the United States pursuant to Executive order of the
p.000001: President;
p.000001: be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law
p.000001: of the United States in the case of commissioned officers of the Army or their surviving bene- ficiaries
p.000001: on account of active military service, except retired pay and uniform allowances.
p.000001: (b) The President may prescribe the conditions under which commissioned officers of the Service may be
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p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
p.000001: applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive
p.000001: depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for
p.000001: the government of the service to which detailed.
p.000001: (b) Upon the request of any State health authority or, in the case of work relating to mental health, any
p.000001: State mental health au-
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
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p.000001: (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to
p.000001: nonprofit edu- cational research or other institutions engaged in health activities for special studies of
p.000001: scientific problems and for the dissemination of information relating to public health.
p.000001: (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the
p.000001: Service except that, in accordance with regulations such personnel may be placed on leave without pay and paid
p.000001: by the State, subdivision, or institution to which they are detailed. In the case of detail of
p.000001: personnel under subsections (b) or (c) to be paid from applicable Service appropria- tions, the Secretary may
p.000001: condition such detail on an agreement by the State, subdivision, or institution concerned that such State,
p.000001: subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by
p.000001: the Service. The services of personnel while detailed pursuant to this section shall be considered as having
p.000001: been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa-
p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
p.000001: may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned
p.000001: under this section to an entity outside of the Department of Health and Human Services for service under
p.000001: the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined
p.000001: in section 203A(a)(5)).
p.000001:
p.000001: REGULATIONS
p.000001: SEC. 215. ø216¿ (a) The President shall from time to time pre- scribe regulations with respect to the
p.000001: appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances
p.000001: (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service.
p.000001: (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall
p.000001: promulgate all other regulations necessary to the administration of the Service, includ- ing regulations
p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
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p.000001: boards of migrant health centers or other entities assisted under section 329. 8 Of such twelve members
p.000001: who are members of such governing boards, at least nine shall be chosen from among those members of
p.000001: such governing boards who are being served by such centers or grantees and who are familiar with the delivery of health
p.000001: care to migratory agricultural workers and seasonal agricultural workers. The re- maining three Council
p.000001: members shall be individuals qualified by training and experience in the medical sciences or in the adminis-
p.000001: tration of health programs.
p.000001: (c) Each member of the Council shall hold office for a term of four years, except that (1) any member
p.000001: appointed to fill a vacancy occurring prior to the expiration of the term for which his prede- cessor was
p.000001: appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after
p.000001: the date of enactment of this subsection shall expire as follows: four shall expire four years after such
p.000001: date, four shall expire three years after such date, four shall expire two years after such date, and three
p.000001: shall expire one year after such date, as designated by the Secretary at the time of appointment.
p.000001: (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
p.000001: TRAINING OF OFFICERS
p.000001: SEC. 218. ø218a¿ (a) Appropriations available for the pay and allowances of commissioned officers of the
p.000001: Service shall also be available for the pay and allowances of any such officer on active
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 8 As a result of the amendments made by Public Law 104–299 (110 Stat. 3626), the Public Health Service
p.000001: Act no longer contained a section 329, 340, or 340A, and section 330 of such Act was substantially revised. Section
p.000001: 330 now includes provisions that relate to medically under- served populations, to migratory and seasonal
p.000001: agricultural workers, to homeless individuals, and to residents of public housing. Section 402 of Public Law 107–251
p.000001: (116 Stat. 1655) added a new section 340 that relates to a healthy communities access program.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 23 PUBLIC HEALTH SERVICE ACT Sec. 219
p.000001:
p.000001: duty while attending any Federal or non-Federal educational insti- tution or training program and, subject to
p.000001: regulations of the Presi- dent and to the limitation prescribed in such appropriations, for payment of his
p.000001: tuition, fees, and other necessary expenses incident to such attendance.
p.000001: (b) Any officer whose tuition, fees, and other necessary ex- penses are paid pursuant to subsection (a) while
p.000001: attending an edu- cational institution or training program for a period in excess of thirty days shall be
p.000001: obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other
p.000001: necessary expenses received by such officer during such period, and two times the total amount of any
p.000001: compensation received by, and any allowance paid to, such officer during such period, if after re- turn
p.000001: to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the
p.000001: period of such attendance, whichever is greater. Such subsequent period of service shall com- mence upon the
p.000001: cessation of such attendance and of any further continuous period of training duty for which no tuition and fees
p.000001: are paid by the Service and which is part of the officer’s prescribed for- mal training program, whether such
p.000001: further training is at Service facility or otherwise. The Surgeon General may waive, in whole or in part, any
p.000001: payment which may be required by this subsection upon a determination that such payment would be
p.000001: inequitable or would not be in public interest.
p.000001: (c) A commissioned officer may be placed in leave without pay
p.000001: status while attending an educational institution or training pro- gram whenever the Secretary determines that
p.000001: such status is in the best interest of the Service. For purposes of computation of basic pay, promotion,
p.000001: retirement, compensation for injury or death, and the benefits provided by sections 212 and 224, an
p.000001: officer in such status pursuant to the preceding sentence shall be considered as performing service in
p.000001: the Service and shall have an active service obligation as set forth in subsection (b) of this section.
p.000001: ANNUAL AND SICK LEAVE
p.000001: SEC. 219. ø210–1¿ (a) In accordance with regulations of the President, commissioned officers of the
p.000001: Regular Corps and officers of the Reserve Corps on active duty may be granted annual leave and sick
p.000001: leave without any deductions from their pay and allow- ances: Provided, That such regulations shall not
p.000001: authorize annual leave to be accumulated in excess of sixty days.
p.000001: (d) 9 For purposes of this section the term ‘‘accumulated annual leave’’ means unused accrued annual leave
p.000001: carried forward from one leave year into a succeeding leave year, and the term ‘‘accrued annual leave’’ means the
p.000001: annual leave accruing to an officer during one leave year.
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001:
p.000001: January 30, 2020
p.000001:
p.000001: 9 Former subsection (b) was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Sec- tion 503(b) of title
p.000001: 37, United States Code, now applies to the matter with which former sub- section (b) was concerned. Former
p.000001: subsection (c) was repealed by section 311 of Public Law 96– 76 (93 Stat. 586).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 220 PUBLIC HEALTH SERVICE ACT 24
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p.000001: January 30, 2020
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p.000001: PROMOTION CREDIT—ASSISTANT GRADE
p.000001: SEC. 220. ø211c¿ Any medical officer of the Regular Corps of the Public Health Service who—
p.000001: (1)(A) was appointed to the assistant grade in the Regular Corps and whose service in such Corps has been
p.000001: continuous from the date of appointment or (B) may hereafter be ap- pointed to the assistant grade in the
p.000001: Regular Corps, and
p.000001: (2) had or will have completed a medical internship on the date of such appointment,
p.000001: shall be credited with one year for purposes of promotion and se- niority in grade, except that no
p.000001: such credit shall be authorized if the officer has received or will receive similar credit for his intern- ship
p.000001: under other provisions of law. In the case of an officer on ac- tive duty on the effective date of this section who is
p.000001: entitled to the credit authorized herein, the one year shall be added to the pro- motion and
p.000001: seniority-in-grade credits with which he is credited on such date.
p.000001: RIGHTS, PRIVILEGES, ETC. OF OFFICERS AND SURVIVING BENEFICIARIES
p.000001: SEC. 221. ø213a¿ (a) Commissioned officers of the Service or their surviving beneficiaries are entitled to all
p.000001: the rights, benefits, privileges, and immunities now or hereafter provided for commis- sioned officers of
p.000001: the Army or their surviving beneficiaries under the following provisions of title 10, United States Code:
p.000001: (1) Section 1036, Escorts for dependents of members: transportation and travel allowances.
p.000001: (2) Chapter 61, Retirement or Separation for Physical Dis- ability, except that sections 1201, 1202, and 1203 do not
p.000001: apply to commissioned officers of the Public Health Service who have been ordered to active duty for training
p.000001: for a period of more than 30 days.
p.000001: (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a).
p.000001: (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401.
p.000001: (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan.
p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
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p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
p.000001: full-time employees of the United States shall, while attending meetings or conferences of such council or
p.000001: committee or otherwise engaged on business of such council or committee receive compensation and allowances as
p.000001: pro- vided in section 208(c) for members of national advisory councils established under this Act.
p.000001: (c) Upon appointment of any such council or committee, the Secretary may delegate to such council or committee
p.000001: such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas
p.000001: or fields with which such council or com- mittee is concerned, as the Secretary determines to be appropriate.
p.000001: VOLUNTEER SERVICES
p.000001: SEC. 223. ø217b¿ Subject to regulations, volunteer and uncom- pensated services may be accepted by the
p.000001: Secretary, or by any other officer or employee of the Department of Health and Human Services designated by him, for
p.000001: use in the operation of any health care facility or in the provision of health care.
p.000001:
p.000001: January 30, 2020 As Amended Through P.L. 116-94,
p.000001: Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 26
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p.000001: January 30, 2020
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p.000001: DEFENSE OF CERTAIN MALPRACTICE AND NEGLIGENCE SUITS
p.000001: SEC. 224. ø233¿ (a) The remedy against the United States pro- vided by sections 1346(b) and 2672 of title 28,
p.000001: or by alternative benefits provided by the United States where the availability of such benefits precludes a
p.000001: remedy under section 1346(b) of title 28, for damage for personal injury, including death, resulting from the
p.000001: performance of medical, surgical, dental, or related functions, in- cluding the conduct of clinical studies or
p.000001: investigation, by any com- missioned officer or employee of the Public Health Service while acting within the
p.000001: scope of his office or employment, shall be exclu- sive of any other civil action or proceeding by reason of
p.000001: the same subject-matter against the officer or employee (or his estate) whose act or omission gave rise to the claim.
p.000001: (b) The Attorney General shall defend any civil action or pro- ceeding brought in any court against any
p.000001: person referred to in sub- section (a) of this section (or his estate) for any such damage or in- jury. Any such person
p.000001: against whom such civil action or proceeding is brought shall deliver within such time after date of service
p.000001: or knowledge of service as determined by the Attorney General, all process served upon him or an attested true
p.000001: copy thereof to his im- mediate superior or to whomever was designated by the Secretary to receive such
p.000001: papers and such persons shall promptly furnish copies of the pleading and process therein to the United States
p.000001: at- torney for the district embracing the place wherein the proceeding is brought, to the Attorney General, and to the
p.000001: Secretary.
p.000001: (c) Upon a certification by the Attorney General that the de- fendant was acting in the scope of his
p.000001: employment at the time of the incident out of which the suit arose, any such civil action or proceeding
p.000001: commenced in a State court shall be removed without bond at any time before trial by the Attorney
p.000001: General to the dis- trict court of the United States of the district and division embrac- ing the place wherein
p.000001: it is pending and the proceeding deemed a tort action brought against the United States under the provisions of
p.000001: title 28 and all references thereto. Should a United States dis- trict court determine on a hearing on a
p.000001: motion to remand held be- fore a trial on the merit that the case so removed is one in which a remedy
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p.000001: States, the case shall be remanded to the State Court: Provided, That where such a remedy is precluded because
p.000001: of the availability of a remedy through pro- ceedings for compensation or other benefits from the United States
p.000001: as provided by any other law, the case shall be dismissed, but in the event the running of any limitation
p.000001: of time for commencing, or filing an application or claim in, such proceedings for compensation or other benefits
p.000001: shall be deemed to have been suspended during the pendency of the civil action or proceeding under this
p.000001: section.
p.000001: (d) The Attorney General may compromise or settle any claim asserted in such civil action or proceeding in the
p.000001: manner provided in section 2677 of title 28 and with the same effect.
p.000001: (e) For purposes of this section, the provisions of section 2680(h) of title 28 shall not apply to
p.000001: assault or battery arising out of negligence in the performance of medical, surgical, dental, or re-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 27 PUBLIC HEALTH SERVICE ACT Sec. 224
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p.000001: lated functions, including the conduct of clinical studies or inves- tigations.
p.000001: (f) The Secretary or his designee may, to the extent that he deems appropriate, hold harmless or provide
p.000001: liability insurance for any officer or employee of the Public Health Service for damage for personal injury, including
p.000001: death, negligently caused by such officer or employee while acting within the scope of his office or employ-
p.000001: ment and as a result of the performance of medical, surgical, den- tal, or related functions, including the conduct of
p.000001: clinical studies or investigations, if such employee is assigned to a foreign country or detailed to a State or
p.000001: political subdivision thereof or to a non-profit institution, and if the circumstances are such as are likely
p.000001: to pre- clude the remedies of third persons against the United States de- scribed in section 2679(b) of
p.000001: title 28, for such damage or injury.
p.000001: (g)(1)(A) For purposes of this section and subject to the ap- proval by the Secretary of an application under
p.000001: subparagraph (D), an entity described in paragraph (4), and any officer, governing board member, or
p.000001: employee of such an entity, and any contractor of such an entity who is a physician or other licensed
p.000001: or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the Public
p.000001: Health Service for a calendar year that begins during a fiscal year for which a transfer was made under
p.000001: subsection (k)(3) (subject to paragraph (3)). The remedy against the United States for an entity
p.000001: described in paragraph (4) and any officer, governing board member, employee, or contractor (subject to
p.000001: paragraph (5)) of such an entity who is deemed to be an employee of the Public Health Service pursuant
p.000001: to this para- graph shall be exclusive of any other civil action or proceeding to the same extent as the
p.000001: remedy against the United States is exclu- sive pursuant to subsection (a).
p.000001: (B) The deeming of any entity or officer, governing board mem- ber, employee, or contractor of the entity to be an
p.000001: employee of the Public Health Service for purposes of this section shall apply with respect to services provided—
p.000001: (i) to all patients of the entity, and
p.000001: (ii) subject to subparagraph (C), to individuals who are not patients of the entity.
p.000001: (C) Subparagraph (B)(ii) applies to services provided to individ- uals who are not patients of an entity if the
p.000001: Secretary determines, after reviewing an application submitted under subparagraph (D), that the provision of the
p.000001: services to such individuals—
p.000001: (i) benefits patients of the entity and general populations that could be served by the entity through
p.000001: community-wide intervention efforts within the communities served by such en- tity;
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p.000001: (ii) facilitates the provision of services to patients of the entity; or
p.000001: (iii) are otherwise required under an employment contract (or similar arrangement) between the entity and an
p.000001: officer, governing board member, employee, or contractor of the entity.
p.000001: (D) The Secretary may not under subparagraph (A) deem an entity or an officer, governing board member,
p.000001: employee, or con- tractor of the entity to be an employee of the Public Health Service for purposes of this
p.000001: section, and may not apply such deeming to
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 28
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p.000001: January 30, 2020
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p.000001: services described in subparagraph (B)(ii), unless the entity has submitted an application for such deeming to
p.000001: the Secretary in such form and such manner as the Secretary shall prescribe. The appli- cation shall contain
p.000001: detailed information, along with supporting documentation, to verify that the entity, and the officer, governing
p.000001: board member, employee, or contractor of the entity, as the case may be, meets the requirements of
p.000001: subparagraphs (B) and (C) of this paragraph and that the entity meets the requirements of para- graphs (1) through
p.000001: (4) of subsection (h).
p.000001: (E) The Secretary shall make a determination of whether an entity or an officer, governing board member,
p.000001: employee, or con- tractor of the entity is deemed to be an employee of the Public Health Service for
p.000001: purposes of this section within 30 days after the receipt of an application under subparagraph (D). The
p.000001: determina- tion of the Secretary that an entity or an officer, governing board member, employee, or
p.000001: contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this
p.000001: section shall apply for the period specified by the Secretary under subpara- graph (A).
p.000001: (F) Once the Secretary makes a determination that an entity or an officer, governing board member,
p.000001: employee, or contractor of an entity is deemed to be an employee of the Public Health Service for purposes of
p.000001: this section, the determination shall be final and binding upon the Secretary and the Attorney General
p.000001: and other parties to any civil action or proceeding. Except as provided in sub- section (i), the Secretary and the
p.000001: Attorney General may not deter- mine that the provision of services which are the subject of such a
p.000001: determination are not covered under this section.
p.000001: (G) In the case of an entity described in paragraph (4) that has not submitted an application under subparagraph (D):
p.000001: (i) The Secretary may not consider the entity in making es- timates under subsection (k)(1).
p.000001: (ii) This section does not affect any authority of the entity to purchase medical malpractice liability insurance
p.000001: coverage with Federal funds provided to the entity under section 329, 330, or 340A.
p.000001: (H) In the case of an entity described in paragraph (4) for which an application under subparagraph (D) is
p.000001: in effect, the entity may, through notifying the Secretary in writing, elect to terminate the applicability of this
p.000001: subsection to the entity. With respect to such election by the entity:
p.000001: (i) The election is effective upon the expiration of the 30- day period beginning on the date on which
p.000001: the entity submits such notification.
p.000001: (ii) Upon taking effect, the election terminates the applica- bility of this subsection to the entity and each
p.000001: officer, gov- erning board member, employee, and contractor of the entity.
p.000001: (iii) Upon the effective date for the election, clauses (i) and
p.000001: (ii) of subparagraph (G) apply to the entity to the same extent and in the same manner as such clauses apply
p.000001: to an entity that has not submitted an application under subparagraph (D).
p.000001: (iv) If after making the election the entity submits an ap- plication under subparagraph (D), the
p.000001: election does not pre-
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p.000001: 29 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: clude the Secretary from approving the application (and 10 thereby restoring the applicability of this
p.000001: subsection to the en- tity and each officer, governing board member, employee, and contractor of the entity,
p.000001: subject to the provisions of this sub- section and the subsequent provisions of this section.
p.000001: (2) If, with respect to an entity or person deemed to be an em- ployee for purposes of paragraph (1), a cause of action
p.000001: is instituted against the United States pursuant to this section, any claim of the entity or person for benefits under
p.000001: an insurance policy with respect to medical malpractice relating to such cause of action shall be sub- rogated to the
p.000001: United States.
p.000001: (3) This subsection shall apply with respect to a cause of action arising from an act or omission which occurs
p.000001: on or after January 1, 1993.
p.000001: (4) An entity described in this paragraph is a public or non- profit private entity receiving Federal funds
p.000001: under section 330.
p.000001: (5) For purposes of paragraph (1), an individual may be consid- ered a contractor of an entity described in
p.000001: paragraph (4) only if—
p.000001: (A) the individual normally performs on average at least 321⁄2 hours of service per week for the entity
p.000001: for the period of the contract; or
p.000001: (B) in the case of an individual who normally performs an average of less than 321⁄2 hours of services per week for the
p.000001: en- tity for the period of the contract, the individual is a licensed or certified provider of services in
p.000001: the fields of family practice, general internal medicine, general pediatrics, or obstetrics and gynecology.
p.000001: (h) The Secretary may not approve an application under sub- section (g)(1)(D) unless the Secretary
p.000001: determines that the entity—
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p.000001: individuals to gain access to this information;
p.000001: (3) has no history of claims having been filed against the United States as a result of the
p.000001: application of this section to the entity or its officers, employees, or contractors as provided for under this
p.000001: section, or, if such a history exists, has fully co- operated with the Attorney General in defending against
p.000001: any such claims and either has taken, or will take, any necessary corrective steps to assure against
p.000001: such claims in the future; and
p.000001: (4) will fully cooperate with the Attorney General in pro-
p.000001: viding information relating to an estimate described under sub- section (k).
p.000001:
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p.000001: January 30, 2020
p.000001: 10 So in law. See section 5(a) of Public Law 104–73 (109 Stat. 779). There is no closing paren- thesis.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 30
p.000001: (i)(1) Notwithstanding subsection (g)(1), the Attorney General, in consultation with the Secretary, may on
p.000001: the record determine, after notice and opportunity for a full and fair hearing, that an in- dividual physician or
p.000001: other licensed or certified health care practi- tioner who is an officer, employee, or contractor of an
p.000001: entity de- scribed in subsection (g)(4) shall not be deemed to be an employee of the Public Health Service for
p.000001: purposes of this section, if treating such individual as such an employee would expose the Government to an
p.000001: unreasonably high degree of risk of loss because such indi- vidual—
p.000001: (A) does not comply with the policies and procedures that the entity has implemented pursuant to subsection
p.000001: (h)(1);
p.000001: (B) has a history of claims filed against him or her as pro- vided for under this section that is outside the
p.000001: norm for li- censed or certified health care practitioners within the same specialty;
p.000001: (C) refused to reasonably cooperate with the Attorney Gen- eral in defending against any such claim;
p.000001: (D) provided false information relevant to the individual’s performance of his or her duties to the Secretary,
p.000001: the Attorney General, or an applicant for or recipient of funds under this Act; or
p.000001: (E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national
p.000001: professional society.
p.000001: (2) A final determination by the Attorney General under this subsection that an individual physician or
p.000001: other licensed or cer- tified health care professional shall not be deemed to be an em- ployee of the
p.000001: Public Health Service shall be effective upon receipt by the entity employing such individual of notice
p.000001: of such deter- mination, and shall apply only to acts or omissions occurring after the date such notice is received.
p.000001: (j) In the case of a health care provider who is an officer, em- ployee, or contractor of an entity
p.000001: described in subsection (g)(4), sec- tion 335(e) shall apply with respect to the provider to the same ex- tent and in
p.000001: the same manner as such section applies to any mem- ber of the National Health Service Corps.
p.000001: (k)(1)(A) For each fiscal year, the Attorney General, in con- sultation with the Secretary, shall estimate by
p.000001: the beginning of the year the amount of all claims which are expected to arise under this section
p.000001: (together with related fees and expenses of witnesses) for which payment is expected to be made in
p.000001: accordance with sec- tion 1346 and chapter 171 of title 28, United States Code, from the acts or omissions, during
p.000001: the calendar year that begins during that fiscal year, of entities described in subsection (g)(4) and of officers,
p.000001: employees, or contractors (subject to subsection (g)(5)) of such enti- ties.
p.000001: (B) The estimate under subparagraph (A) shall take into ac- count—
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p.000001: (i) the value and frequency of all claims for damage for personal injury, including death, resulting
p.000001: from the perform- ance of medical, surgical, dental, or related functions by enti- ties described in
p.000001: subsection (g)(4) or by officers, employees, or contractors (subject to subsection (g)(5)) of such
p.000001: entities who
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p.000001: (ii) the amounts paid during that 5-year period on all claims described in clause (i), regardless of
p.000001: when such claims were filed, adjusted to reflect payments which would not be permitted under section 1346
p.000001: and chapter 171 of title 28,
p.000001: United States Code, and
p.000001: (iii) amounts in the fund established under paragraph (2) but unspent from prior fiscal years.
p.000001: (2) Subject to appropriations, for each fiscal year, the Secretary shall establish a fund of an amount equal to the
p.000001: amount estimated under paragraph (1) that is attributable to entities receiving funds under each of the grant
p.000001: programs described in paragraph (4) of subsection (g), but not to exceed a total of $10,000,000 for
p.000001: each such fiscal year. Appropriations for purposes of this paragraph shall be made separate from
p.000001: appropriations made for purposes of sections 329, 330 and 340A.
p.000001: (3) In order for payments to be made for judgments against the United States (together with related fees and
p.000001: expenses of wit- nesses) pursuant to this section arising from the acts or omissions of entities described in
p.000001: subsection (g)(4) and of officers, 11 employ- ees, or contractors (subject to subsection (g)(5)) of such entities,
p.000001: the total amount contained within the fund established by the Sec- retary under paragraph (2) for a fiscal
p.000001: year shall be transferred not later than the December 31 that occurs during the fiscal year to the
p.000001: appropriate accounts in the Treasury.
p.000001: (l)(1) If a civil action or proceeding is filed in a State court against any entity described in subsection
p.000001: (g)(4) or any officer, gov- erning board member, employee, or any contractor of such an enti- ty for damages
p.000001: described in subsection (a), the Attorney General, within 15 days after being notified of such filing, shall make
p.000001: an ap- pearance in such court and advise such court as to whether the Secretary has determined under
p.000001: subsections (g) and (h), that such entity, officer, governing board member, employee, or contractor of the entity
p.000001: is deemed to be an employee of the Public Health Service for purposes of this section with respect to the actions or
p.000001: omissions that are the subject of such civil action or proceeding. Such advice shall be deemed to satisfy the
p.000001: provisions of subsection (c) that the Attorney General certify that an entity, officer, governing board member,
p.000001: employee, or contractor of the entity was acting within the scope of their employment or responsibility.
p.000001: (2) If the Attorney General fails to appear in State court within the time period prescribed under paragraph (1),
p.000001: upon petition of any entity or officer, governing board member, employee, or con- tractor of the entity
p.000001: named, the civil action or proceeding shall be removed to the appropriate United States district court.
p.000001: The civil action or proceeding shall be stayed in such court until such court conducts a hearing, and makes a
p.000001: determination, as to the appro-
p.000001:
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p.000001: January 30, 2020
p.000001: 11 Section 3(2) of Public Law 104–73 (109 Stat. 778) provides that subsection (k)(3) is amended by inserting
p.000001: ‘‘governing board member,’’ after ‘‘officer,’’. The amendment cannot be executed be- cause the latter term does not
p.000001: appear. (Compare ‘‘officer,’’ and ‘‘officers,’’.)
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 32
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p.000001: January 30, 2020
p.000001:
p.000001: priate forum or procedure for the assertion of the claim for dam- ages described in subsection (a) and
p.000001: issues an order consistent with such determination.
p.000001: (m)(1) An entity or officer, governing board member, employee, or contractor of an entity described in
p.000001: subsection (g)(1) shall, for purposes of this section, be deemed to be an employee of the Public Health Service with
p.000001: respect to services provided to individuals who are enrollees of a managed care plan if the entity contracts
p.000001: with such managed care plan for the provision of services.
p.000001: (2) Each managed care plan which enters into a contract with an entity described in subsection (g)(4) shall deem
p.000001: the entity and any officer, governing board member, employee, or contractor of the entity as meeting whatever
p.000001: malpractice coverage requirements such plan may require of contracting providers for a calendar year if such
p.000001: entity or officer, governing board member, employee, or con- tractor of the entity has been deemed to be an employee of
p.000001: the Pub- lic Health Service for purposes of this section for such calendar year. Any plan which is found by
p.000001: the Secretary on the record, after notice and an opportunity for a full and fair hearing, to have vio-
p.000001: lated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to
p.000001: be eligible to re- ceive any Federal funds under titles XVIII or XIX of the Social Se- curity Act.
p.000001: (3) For purposes of this subsection, the term ‘‘managed care plan’’ shall mean health maintenance
p.000001: organizations and similar en- tities that contract at-risk with payors for the provision of health services
p.000001: or plan enrollees and which contract with providers (such as entities described in subsection (g)(4)) for
p.000001: the delivery of such services to plan enrollees.
p.000001: (n)(1) Not later than one year after the date of the enactment of the Federally Supported Health Centers
p.000001: Assistance Act of 1995, the Comptroller General of the United States shall submit to the Congress a report on
p.000001: the following:
p.000001: (A) The medical malpractice liability claims experience of entities that have been deemed to be employees
p.000001: for purposes of this section.
p.000001: (B) The risk exposure of such entities.
p.000001: (C) The value of private sector risk-management services, and the value of risk-management services and
...

p.000001: purposes of this sec- tion) will purchase after the date of the enactment of the Federally Supported
p.000001: Health Centers Assistance Act of 1995.
p.000001: (C) An estimate of the medical malpractice liability loss history of such entities for the 10-year
p.000001: period preceding Octo- ber 1, 1996, including but not limited to the following:
p.000001: (i) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims
p.000001: that have been paid and that are estimated to be paid, by the Federal Government pursuant to deeming
p.000001: entities as em- ployees for purposes of this section.
p.000001: (ii) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims
p.000001: that have been paid and that are estimated to be paid, by pri- vate medical malpractice liability insurance.
p.000001: (D) An analysis of whether the cost of premiums for pri- vate medical malpractice liability insurance
p.000001: coverage is con- sistent with the liability claims experience of entities that have been deemed as employees for
p.000001: purposes of this section.
p.000001: (3) In preparing the report under paragraph (1), the Comp- troller General of the United States shall
p.000001: consult with public and private entities with expertise on the matters with which the re- port is
p.000001: concerned.
p.000001: (o)(1) For purposes of this section, a free clinic health profes- sional shall in providing a qualifying
p.000001: health service to an indi- vidual, or an officer, governing board member, employee, or con- tractor of a
p.000001: free clinic shall in providing services for the free clinic, be deemed to be an employee of the Public Health Service
p.000001: for a cal- endar year that begins during a fiscal year for which a transfer was made under paragraph
p.000001: (6)(D). The preceding sentence is sub- ject to the provisions of this subsection.
p.000001: (2) In providing a health service to an individual, a health care practitioner shall for purposes of this
p.000001: subsection be considered to
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 34
p.000001: be a free clinic health professional if the following conditions are met:
p.000001:
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p.000001: (A) The service is provided to the individual at a free clin- ic, or through offsite programs or events carried out by
p.000001: the free clinic.
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p.000001: 35 PUBLIC HEALTH SERVICE ACT Sec. 224
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p.000001: January 30, 2020
p.000001: provided in the program under title XIX of the Social Security Act, without regard to whether the medical assistance is
p.000001: included in the plan submitted under such program by the State in which the health care practitioner
p.000001: involved provides the medical assistance. References in the preceding sentence to such program shall as ap-
p.000001: plicable be considered to be references to any successor to such pro- gram.
p.000001: (5) Subsection (g) (other than paragraphs (3) through (5)) and subsections (h), (i), and (l) apply to a
p.000001: health care practitioner for purposes of this subsection to the same extent and in the same manner as
p.000001: such subsections apply to an officer, governing board member, employee, or contractor of an entity
p.000001: described in sub- section (g)(4), subject to paragraph (6) and subject to the following:
p.000001: (A) The first sentence of paragraph (1) applies in lieu of the first sentence of subsection (g)(1)(A).
p.000001: (B) This subsection may not be construed as deeming any free clinic to be an employee of the Public
p.000001: Health Service for purposes of this section.
p.000001: (C) With respect to a free clinic, a health care practitioner is not a free clinic health professional unless
p.000001: the free clinic sponsors the health care practitioner. For purposes of this sub- section, the free clinic shall be
p.000001: considered to be sponsoring the health care practitioner if—
p.000001: (i) with respect to the health care practitioner, the free clinic submits to the Secretary an application meeting the
p.000001: requirements of subsection (g)(1)(D); and
p.000001: (ii) the Secretary, pursuant to subsection (g)(1)(E), de- termines that the health care practitioner is deemed to be an
p.000001: employee of the Public Health Service.
p.000001: (D) In the case of a health care practitioner who is deter- mined by the Secretary pursuant to
p.000001: subsection (g)(1)(E) to be a free clinic health professional, this subsection applies to the health care
p.000001: practitioner (with respect to the free clinic spon- soring the health care practitioner pursuant to
p.000001: subparagraph (C)) for any cause of action arising from an act or omission of the health care
p.000001: practitioner occurring on or after the date on which the Secretary makes such determination.
p.000001: (E) Subsection (g)(1)(F) applies to a health care practi- tioner for purposes of this subsection only to
...

p.000001: care practitioner may receive repayment from the entity described in subsection (g)(4) for reasonable ex-
p.000001: penses incurred by the health care practitioner in the provision of the service to the individual, which may
p.000001: include travel ex- penses to or from the site of services.
p.000001: (D) Before the service is provided, the health care practi- tioner or the entity described in subsection
p.000001: (g)(4) posts a clear and conspicuous notice at the site where the service is provided of the extent to which the
p.000001: legal liability of the health care practitioner is limited pursuant to this subsection.
p.000001: (E) At the time the service is provided, the health care practitioner is licensed or certified in accordance
p.000001: with applica- ble Federal and State laws regarding the provision of the serv- ice.
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p.000001: January 30, 2020
p.000001: (F) At the time the service is provided, the entity described in subsection (g)(4) maintains relevant
p.000001: documentation certi- fying that the health care practitioner meets the requirements of this subsection.
p.000001: (3) Subsection (g) (other than paragraphs (3) and (5)) and sub- sections (h), (i), and (l) apply to a health care
p.000001: practitioner for pur- poses of this subsection to the same extent and in the same man- ner as such
p.000001: subsections apply to an officer, governing board mem- ber, employee, or contractor of an entity described
p.000001: in subsection (g)(4), subject to paragraph (4), and subject to the following:
p.000001: (A) The first sentence of paragraph (1) applies in lieu of the first sentence of subsection (g)(1)(A).
p.000001: (B) With respect to an entity described in subsection (g)(4), a health care practitioner is not a health professional
p.000001: volunteer at such entity unless the entity sponsors the health care prac- titioner. For purposes of this
p.000001: subsection, the entity shall be considered to be sponsoring the health care practitioner if—
p.000001: (i) with respect to the health care practitioner, the en- tity submits to the Secretary an application meeting
p.000001: the requirements of subsection (g)(1)(D); and
p.000001: (ii) the Secretary, pursuant to subsection (g)(1)(E), de- termines that the health care practitioner is deemed to be an
p.000001: employee of the Public Health Service.
p.000001: (C) In the case of a health care practitioner who is deter- mined by the Secretary pursuant to
p.000001: subsection (g)(1)(E) to be a health professional volunteer at such entity, this subsection applies to the
p.000001: health care practitioner (with respect to services performed on behalf of the entity sponsoring the health
p.000001: care practitioner pursuant to subparagraph (B)) for any cause of ac- tion arising from an act or omission of
p.000001: the health care practi- tioner occurring on or after the date on which the Secretary makes such
p.000001: determination.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017: Sec. 237 PUBLIC HEALTH SERVICE ACT 52
p.000017:
p.000017: AVAILABILITY OF APPROPRIATIONS
p.000017: SEC. 237. ø238f¿ Appropriations for carrying out the purposes of this Act shall be available for
p.000017: expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and
p.000017: exhibits; printing and binding; transporting in Government- owned automotive equipment, to and from school,
p.000017: children of per- sonnel who have quarters for themselves and their families at sta- tions determined by the
p.000017: Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who
p.000017: escape from any hospital, institution, or station of the Service or from the custody of any officer or employee
p.000017: of the Service, in- cluding rewards for the capture of such prisoners; furnishing, re- pairing, and
p.000017: cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the
p.000017: performance of their official duties; reimbursing officers and employees, subject to regulations of the
p.000017: Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients
p.000017: while such officers or employees are engaged in the performance of their official duties; and maintenance of
p.000017: buildings of the National Institutes of Health.
p.000017: UNAUTHORIZED WEARING OF UNIFORMS
p.000017: SEC. 238. ø238g¿ Except as may be authorized by regulations of the President, the insignia and uniform of
p.000017: commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia
p.000017: or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of
p.000017: such regulations, by any person other than a commissioned officer of the Service.
p.000017: BIANNUAL REPORT
p.000017: SEC. 239. ø238h¿ The Surgeon General shall transmit to the Secretary, for submission to the Congress, on
p.000017: January 1, 1995, and on January 1, every 2 years thereafter, a full report of the adminis- tration of the functions
p.000017: of the Service under this Act, including a detailed statement of receipts and disbursements.
p.000017: MEMORIALS AND OTHER ACKNOWLEDGMENTS
p.000017: SEC. 240. ø238i¿ The Secretary may provide for suitably ac- knowledging, within the Department (whether
p.000017: by memorials, des- ignations, or other suitable acknowledgments), (1) efforts of persons who have contributed
p.000017: substantially to the health of the Nation and
p.000017: (2) gifts for use in activities of the Department related to health.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017:
p.000017: EVALUATION OF PROGRAMS
p.000017: SEC. 241. ø238j¿ (a) IN GENERAL.—Such portion as the Sec- retary shall determine, but not less than 0.2
p.000017: percent nor more than
p.000017: 1 percent, of any amounts appropriated for programs authorized under this Act shall be made available for the
p.000017: evaluation (directly, or by grants of contracts) of the implementation and effectiveness of such programs.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017: of the House of Representatives a report summarizing the findings of the evaluations conducted under
p.000017: subsection (a).
p.000017: CONTRACT AUTHORITY
p.000017: SEC. 242. ø238k¿ The authority of the Secretary to enter into contracts under this Act shall be
p.000017: effective for any fiscal year only to such extent or in such amounts as are provided in advance by
p.000017: appropriation Acts.
p.000017:
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p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: RECOVERY
p.000017: SEC. 243. ø238l¿ (a) If any facility with respect to which funds have been paid under the Community Mental
p.000017: Health Centers Act (as such Act was in effect prior to October 1, 1981) is, at any time within twenty years after
p.000017: the completion of remodeling, construc- tion, or expansion or after the date of its acquisition—
p.000017: (1) sold or transferred to any entity (A) which would not have been qualified to file an application
p.000017: under section 222 of such Act (as such section was in effect prior to October 1, 1981) or (B) which is disapproved
p.000017: as a transferee by the State mental health agency or by another entity designated by the chief ex- ecutive officer of
p.000017: the State, or
p.000017: (2) ceases to be used by a community mental health center in the provision of comprehensive mental health services,
p.000017: the United States shall be entitled to recover from the transferor, transferee, or owner of the facility, the
p.000017: base amount prescribed by subsection (c)(1) plus the interest (if any) prescribed by subsection (c)(2).
p.000017: (b) The transferor and transferee of a facility that is sold or transferred as described in subsection
p.000017: (a)(1), or the owner of a facil- ity the use of which changes as described in subsection (a)(2), shall provide the
p.000017: Secretary written notice of such sale, transfer, or change within 10 days after the date on which such sale,
p.000017: transfer, or cessation of use occurs or within 30 days after the date of enact- ment of this subsection, whichever is
p.000017: later.
p.000017: (c)(1) The base amount that the United States is entitled to re- cover under subsection (a) is the amount bearing the
p.000017: same ratio to the then value (as determined by the agreement of the parties or in an action brought in
p.000017: the district court of the United States for the district in which the facility is situated) of so much of the
p.000017: facil- ity as constituted an approved project or projects as the amount of the Federal participation bore to the
p.000017: cost of the remodeling, con- struction, expansion, or acquisition of the project or projects.
p.000017: (2)(A) The interest that the United States is entitled to recover under subsection (a) is the interest for the period
p.000017: (if any) described in subparagraph (B) at a rate (determined by the Secretary) based on the average of the bond
p.000017: equivalent rates of ninety-one-day Treasury bills auctioned during that period.
...

p.000017: (e) STRUCTURED SETTLEMENTS AT SECRETARY’S OPTION.—In any case in which there is a reasonable
p.000017: likelihood that compensa- tion or payment under section 264, 265, or 266(b) will be required for a period in
p.000017: excess of one year from the date an individual is determined eligible for such compensation or payment,
p.000017: the Sec- retary shall have the discretion to make a lump-sum payment, pur- chase an annuity or medical insurance
p.000017: policy, or execute an appro- priate structured settlement agreement, provided that such pay- ment, annuity,
p.000017: policy, or agreement is actuarially determined to have a value equal to the present value of the
p.000017: projected total amount of benefits or compensation that the individual is eligible to receive under such
p.000017: section or sections.
p.000017: (f) REVIEW OF DETERMINATION.—
p.000017: (1) SECRETARY’S REVIEW AUTHORITY.—The Secretary may review a determination under this section at any
p.000017: time on the Secretary’s own motion or on application, and may affirm, va- cate, or modify such
p.000017: determination in any manner the Sec- retary deems appropriate. The Secretary shall develop a proc- ess by
p.000017: which an individual may file a request for reconsider- ation of any determination made by the Secretary
p.000017: under this section.
p.000017: (2) JUDICIAL AND ADMINISTRATIVE REVIEW.—No court of the United States, or of any State, District, territory or
p.000017: possession thereof, shall have subject matter jurisdiction to review, whether by mandamus or
p.000017: otherwise, any action by the Sec- retary under this section. No officer or employee of the United States shall
p.000017: review any action by the Secretary under this sec- tion (unless the President specifically directs otherwise).
p.000017: SEC. 263. ø239b¿ SMALLPOX VACCINE INJURY TABLE.
p.000017: (a) 21 SMALLPOX VACCINE INJURY TABLE.—
p.000017: (1) ESTABLISHMENT REQUIRED.—The Secretary shall estab- lish by interim final regulation a table identifying
p.000017: adverse ef- fects (including injuries, disabilities, illnesses, conditions, and deaths) that shall be
p.000017: presumed to result from the administra- tion of (or exposure to) a smallpox vaccine, and the time period in which
p.000017: the first symptom or manifestation of onset of each such adverse effect must manifest in order for
p.000017: such presump- tion to apply.
p.000017: (2) AMENDMENTS.—The Secretary may by regulation amend the table established under paragraph (1).
p.000017: An amend-
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 21 Subsection (a) designation so in law. Section 263 does not contain a subsection (b). See the amendment made by
p.000017: section 2 of Public Law 108–20 (117 Stat. 638, 641), which added a new part C to title II.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017: 63 PUBLIC HEALTH SERVICE ACT Sec. 265
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
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p.000017: expand, intensify, and co- ordinate the activities of the Centers for Disease Control and Pre- vention with
p.000017: respect to preterm labor and delivery and infant mor- tality.
p.000017: (f)(1) The Secretary may exempt from disclosure under section 552(b)(3) of title 5, United States Code, biomedical
p.000017: information that is about an individual and that is gathered or used during the course of biomedical
p.000017: research if—
p.000017: (A) an individual is identified; or
p.000017: (B) there is at least a very small risk, as determined by current scientific practices or statistical
p.000017: methods, that some combination of the information, the request, and other avail- able data sources could be
p.000017: used to deduce the identity of an in- dividual.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 77 PUBLIC HEALTH SERVICE ACT Sec. 302
p.000017:
p.000017: (2)(A) Each determination of the Secretary under paragraph (1) to exempt information from disclosure shall be made in
p.000017: writing and accompanied by a statement of the basis for the determination.
p.000017: (B) Each such determination and statement of basis shall be available to the public, upon request,
p.000017: through the Office of the Chief FOIA Officer of the Department of Health and Human Serv- ices.
p.000017: (3) Nothing in this subsection shall be construed to limit a re- search participant’s access to information about
p.000017: such participant collected during the participant’s participation in the research.
p.000017: (g) Subchapter I of chapter 35 of title 44, United States Code, shall not apply to the voluntary collection of
p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
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p.000017: obtained in the course of activities undertaken or supported under section 304, 306, or 307 may be used for any
p.000017: purpose other than the purpose for which it was supplied unless such establishment or person has
p.000017: consented (as determined under regulations of the Secretary) to its use for such other purpose and in
p.000017: the case of information obtained in the course of health statistical or epidemiological activities under
p.000017: sec- tion 304 or 306, such information may not be published or released in other form if the particular
p.000017: establishment or person supplying the information or described in it is identifiable unless such estab- lishment or
p.000017: person has consented (as determined under regulations of the Secretary) to its publication or release in other form.
p.000017: (e)(1) Payments of any grant or under any contract under sec- tion 304, 306, or 307 may be made in advance or
p.000017: by way of reim- bursement, and in such installments and on such conditions, as the Secretary deems necessary to
p.000017: carry out the purposes of such sec- tion.
p.000017: (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307
p.000017: shall be re- duced by—
p.000017: (A) amounts equal to the fair market value of any equip- ment or supplies furnished to such person by the
p.000017: Secretary for the purpose of carrying out the project with respect to which such grant or contract is made,
p.000017: and
p.000017: (B) amounts equal to the pay, allowances, traveling ex- penses, and related personnel expenses attributable to
p.000017: the per- formance of services by an officer or employee of the Govern- ment in connection with such
p.000017: project, if such officer or em- ployee was assigned or detailed by the Secretary to perform such
p.000017: services,
p.000017: but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as
p.000017: the case may be.
p.000017: (f) Contracts may be entered into under section 304 or 306 without regard to section 3324 of title 31, United
p.000017: States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5).
p.000017: HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION
p.000017: SEC. 310. 5 ø242o¿ (a) A conference of the health authorities in and among the several States shall be called
p.000017: annually by the Sec- retary. Whenever in his opinion the interests of the public health
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 5 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat. 2205).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017:
p.000017: 89 PUBLIC HEALTH SERVICE ACT Sec. 310A
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p.000101: (B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and
p.000101: (C) the applicant will comply with the assurances provided with the application.
p.000101: (2) The Secretary shall review annually the activities under- taken by each recipient of a grant under
p.000101: subsection (a) to deter- mine if the program assisted by such grant is operating effectively to achieve its stated
p.000101: purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.
p.000101: (d) The amount of a grant under subsection (a) shall be deter- mined by the Secretary. Payments under such grants may
p.000101: be made in advance on the basis of estimates or by the way of reimburse- ment, with necessary adjustments
p.000101: on account of underpayments or overpayments, and in such installments and on such terms and conditions as
p.000101: the Secretary finds necessary to carry out the pur- poses of such grants.
p.000101: (e) The Secretary, at the request of a recipient of a grant under subsection (a), may reduce the amount of such grant
p.000101: by—
p.000101: (1) the fair market value of any supplies (including vac- cines and other preventive agents) or equipment
p.000101: furnished the grant recipient, and
p.000101: (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed
p.000101: to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or
p.000101: employee.
p.000101: When the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience
p.000101: of and at the re- quest of such grant recipient and for the purpose of carrying out a program with
p.000101: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall
p.000101: be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in
p.000101: detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of
p.000101: the grant and shall be deemed to have been paid to the grant recipient.
p.000101: (f)(1) Each recipient of a grant under subsection (a) shall keep such records as the Secretary shall by regulation
p.000101: prescribe, includ- ing records which fully disclose the amount and disposition by such recipient of the proceeds of
p.000101: such grant, the total cost of the under- taking in connection with which such grant was made, and the amount
p.000101: of that portion of the cost of the undertaking supplied by other sources, and such other records as will
p.000101: facilitate an effective audit.
p.000101: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000101: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000101: records of the recipient of grants under sub- section (a) that are pertinent to such grants.
p.000101: (g)(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to
p.000101: a State or to an agency or a political subdivision of a State under provisions of Federal law (other
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p.000107: January 30, 2020
p.000107: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.000107: health benefits program; or
p.000107: (B) by an entity that provides health services on a pre- paid basis.
p.000107: (2) APPLICABILITY TO CERTAIN SECONDARY AGREEMENTS FOR PROVISION OF SERVICES.—Paragraph (1) shall not
p.000107: apply in the case of a provider through which a grantee under sub- section (a) provides services under
p.000107: such subsection if the Sec- retary has provided a waiver under subsection (b)(2) regarding the provider.
p.000107: (f) METHOD AND AMOUNT OF PAYMENT.—The Secretary shall determine the amount of a grant made under
p.000107: subsection (a). Pay- ments under such grants may be made in advance on the basis of estimates or by way
p.000107: of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such install- ments
p.000107: and on such terms and conditions as the Secretary finds nec- essary to carry out the purposes of such grants. Not more
p.000107: than 10 percent of any grant may be obligated for administrative costs.
p.000107: (g) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The Sec- retary, at the request of a recipient of a grant under
p.000107: subsection (a), may reduce the amount of such grant by—
p.000107: (1) the fair market value of any supplies or equipment fur- nished the grant recipient; and
p.000107: (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed
p.000107: to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or
p.000107: employee;
p.000107: when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience
p.000107: of and at the re- quest of such grant recipient and for the purpose of carrying out a program with
p.000107: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced shall
p.000107: be available for payment by the Secretary of the costs incurred in fur- nishing the supplies or equipment, or in
p.000107: detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of
p.000107: the grant and shall be deemed to have been paid to the grant recipient.
p.000107: (h) RECORDS.—Each recipient of a grant under subsection (a) shall keep such records as the Secretary
p.000107: shall prescribe, including records which fully disclose the amount and disposition by such re- cipient of the
p.000107: proceeds of such grant, the total cost of the under- taking in connection with which such grant was
p.000107: made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such
p.000107: other records as will facilitate an effective audit.
p.000107: (i) AUDIT AND EXAMINATION OF RECORDS.—The Secretary and the Comptroller General of the United States, or any of
p.000107: their duly authorized representatives, shall have access for the purpose of audit and examination to
p.000107: any books, documents, papers, and records of the recipient of a grant under subsection (a), that are
p.000107: pertinent to such grant.
p.000107: (j) ANNUAL REPORT.—
p.000107: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000107:
p.000107:
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p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
p.000111: sub- paragraph (B), and amounts available for carrying out the programs and functions, are transferred to the
p.000111: Center, ef- fective upon the expiration of the 180-day period beginning on the date of the enactment of the Act
p.000111: referred to in sub- paragraph (A). Such transfer of amounts does not affect the period of availability of
p.000111: the amounts, or the avail- ability of the amounts with respect to the purposes for which the amounts may
p.000111: be expended.
p.000111: (b) GRANTS AND CONTRACTS.—
p.000111: (1) IN GENERAL.—In carrying out subsection (a), the Sec- retary may make grants to and enter into contracts
p.000111: with public and nonprofit private entities.
p.000111: (2) SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.—
p.000111: (A) Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary
p.000111: may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the
p.000111: recipient in car- rying out the purposes for which the award is made and, for such purposes, may detail
p.000111: to the recipient any officer or employee of the Department of Health and Human Services.
p.000111:
p.000111:
p.000111:
p.000111: January 30, 2020
p.000111: 10 Public Law 106–310, enacted October 17, 2000.
p.000111: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000111: pay- ments under the award involved by an amount equal to the costs of detailing personnel and the
p.000111: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall,
p.000111: for the payment of ex- penses incurred in complying with such request, expend the amounts withheld.
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p.000115: subsection (a). Pay- ments under such grants may be made in advance on the basis of estimates or by way
p.000115: of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such in-
p.000115: stallments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
p.000115: (j) TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND
p.000115: SERVICES IN LIEU OF GRANT FUNDS.—
p.000115: (1) TECHNICAL ASSISTANCE.—The Secretary may provide training and technical assistance with respect to the
p.000115: planning,
p.000115:
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p.000115: January 30, 2020
p.000115: 12 So in law.
p.000115:
p.000115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000117: 117
p.000117: PUBLIC HEALTH SERVICE ACT
p.000117: Sec. 317E
p.000117:
p.000117: development, and operation of any program or service carried out pursuant to subsection (a). The Secretary may
p.000117: provide such technical assistance directly or through grants to, or contracts with, public and private entities.
p.000117: (2) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
p.000117: (A) Upon the request of an applicant receiving a grant under subsection (a), the Secretary may, subject to sub-
p.000117: paragraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out
p.000117: such section and, for such purpose, may detail to the applicant any officer or employee of the
p.000117: Department of Health and Human Services.
p.000117: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000117: pay- ments under the grant under subsection (a) to the appli- cant involved by an amount equal to the costs
p.000117: of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any
p.000117: supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses
p.000117: incurred in complying with such request, expend the amounts withheld.
p.000117: (k) DEFINITION.—For purposes of this section, the term ‘‘units of local government’’ includes Indian tribes.
p.000117: (l) AUTHORIZATION OF APPROPRIATIONS.—
p.000117: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000117: $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.
p.000117: (2) ALLOCATION FOR TECHNICAL ASSISTANCE.—Of the amounts appropriated under paragraph (1) for a
p.000117: fiscal year, the Secretary shall reserve not more than 20 percent for car- rying out subsection (j)(1).
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p.000117: January 30, 2020
p.000117: NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS
p.000117: SEC. 317E. ø247b–6¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
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p.000119: (3) DETERMINATION OF AMOUNT OF NONFEDERAL CONTRIBU- TIONS.—
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p.000119: January 30, 2020
p.000119: (A) PRIORITY.—In awarding grants under subsection
p.000119: (a) or (b), the Secretary shall give highest priority to an applicant that provides assurances that the
p.000119: applicant will contribute non-Federal funds to carry out activities under this section, which may be provided
p.000119: directly or through do- nations from public or private entities and may be in cash or in kind, including equipment or
p.000119: services.
p.000119: (B) FEDERAL AMOUNTS NOT TO BE INCLUDED AS CON- TRIBUTIONS.—Amounts provided by the Federal Govern- ment,
p.000119: or services assisted or subsidized to any significant extent by the Federal Government, may not be included in
p.000119: determining the amount of non-Federal contributions as described in subparagraph (A).
p.000119: (e) SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
p.000119: (1) IN GENERAL.—Upon the request of a grantee under sub- section (a) or (b), the Secretary may, subject to
p.000119: paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out
p.000119: the subsection involved and, for such purpose, may detail to the State any officer or em- ployee of the
p.000119: Department of Health and Human Services.
p.000119: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.000119: Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing
p.000119: personnel and the fair market value of any supplies, equipment, or services pro- vided by the Secretary.
p.000119: The Secretary shall, for the payment of expenses incurred in complying with such request, expend the
p.000119: amounts withheld.
p.000119: (f) ADVISORY COUNCIL.—
p.000119: (1) IN GENERAL.—The Secretary shall establish an advisory council to be known as the Advisory Council for the
p.000119: Elimi- nation of Tuberculosis (in this subsection referred to as the ‘‘Council’’).
p.000119: (2) DUTIES.—The Council shall provide advice and rec- ommendations regarding the elimination of tuberculosis to
p.000119: the Secretary. In addition, the Council shall, with respect to elimi- nating such disease, provide to the Secretary and
p.000119: other appro- priate Federal officials advice on—
p.000119: (A) coordinating the activities of the Department of Health and Human Services and other Federal agencies
p.000119: that relate to the disease, including activities under sub- section (b);
p.000119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000147: payment, in such amounts and subject to such terms and conditions, of such costs and expenses hereafter incurred by or
p.000147: on behalf of such person’s wife or offspring determined by the Secretary to have suffered injury or disease from
p.000147: syphilis contracted from such person’’.
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000147: Sec. 318A PUBLIC HEALTH SERVICE ACT 148
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p.000147: proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was
p.000147: given or used and the amount of that portion of the cost of the project or undertaking supplied by other
p.000147: sources, and such other records as will facilitate an effective audit.
p.000147: (3) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.000147: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.000147: records of the recipients of grants under this section that are pertinent to such grants.
p.000147: (4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair
p.000147: market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances,
p.000147: travel expenses, and any other costs in connection with the detail of an officer or employee of the United
p.000147: States to the recipient when the furnishing of such supplies or equipment or the detail of such an
p.000147: officer or employee is for the convenience of and at the request of such recipient and for the pur- pose of
p.000147: carrying out the program with respect to which the grant under this section is made. The amount by
p.000147: which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in
p.000147: furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
p.000147: (5) All information obtained in connection with the examina- tion, care, or treatment of any individual under
p.000147: any program which is being carried out with a grant made under this section shall not, without such individual’s
p.000147: consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a
p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
p.000147: (A) in summary, statistical, or other form; or
p.000147: (B) for clinical or research purposes;
p.000147: but only if the identity of the individuals diagnosed or provided care or treatment under such program is not
p.000147: disclosed.
p.000147: (f) Nothing in this section shall be construed to require any State or any political subdivision of a
p.000147: State to have a sexually transmitted diseases program which would require any person, who objects to any
p.000147: treatment provided under such a program, to be treated under such a program.
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p.000151: and control of sexually transmitted diseases, including programs to provide to the public information and edu- cation
p.000151: regarding such diseases; and
p.000151: (ii) representatives of entities in such area that provide family planning services.
p.000151: (m) DURATION OF GRANT.—The period during which payments are made to an entity from a grant under subsection
p.000151: (a) may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary
p.000151: of the payments and subject to the availability of appropriations for the fiscal year involved to make
p.000151: the payments in such year. The preceding sentence may not be construed to establish a limitation on the number
p.000151: of grants under such subsection that may be made to an entity.
p.000151: (n) TECHNICAL ASSISTANCE, AND SUPPLIES AND SERVICES IN
p.000151: LIEU OF GRANT FUNDS.—
p.000151: (1) TECHNICAL ASSISTANCE.—The Secretary may provide training and technical assistance to grantees under subsection
p.000151: (a) with respect to the planning, development, and operation of any program or service carried out under such
p.000151: subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
p.000151: (2) SUPPLIES, EQUIPMENT, AND EMPLOYEE DETAIL.—The Secretary, at the request of a recipient of a
p.000151: grant under sub- section (a), may reduce the amount of such grant by—
p.000151: (A) the fair market value of any supplies or equipment furnished the grant recipient; and
p.000151: (B) the amount of the pay, allowances, and travel ex- penses of any officer or employee of the Government when
p.000151: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000151: Sec. 318A PUBLIC HEALTH SERVICE ACT 152
p.000151:
p.000151: detailed to the grant recipient and the amount of any other costs incurred in connection with the
p.000151: detail of such officer or employee;
p.000151: when the furnishing of such supplies or equipment or the de- tail of such an officer or employee is for the
p.000151: convenience of and at the request of such grant recipient and for the purpose of carrying out a program with
p.000151: respect to which the grant under subsection (a) is made. The amount by which any such grant is so reduced
p.000151: shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or
p.000151: equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount
p.000151: shall be deemed as part of the grant and shall be deemed to have been paid to the grant re- cipient.
p.000151: (o) EVALUATIONS AND REPORTS BY SECRETARY.—
p.000151: (1) EVALUATIONS.—The Secretary shall, directly or through contracts with public or private entities, provide for
p.000151: annual evaluations of programs carried out pursuant to subsection (a) in order to determine the quality and
p.000151: effectiveness of the pro- grams.
p.000151: (2) REPORT TO CONGRESS.—Not later than 1 year after the date on which amounts are first appropriated pursuant to sub-
p.000151: section (q), and biennially thereafter, the Secretary shall sub- mit to the Committee on Energy and
p.000151: Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the
p.000151: Senate, a report—
p.000151: (A) summarizing the information provided to the Sec- retary in reports made pursuant to subsection
p.000151: (j)(1), in- cluding information on the incidence of sexually trans- mitted diseases described in subsection
p.000151: (a); and
p.000151: (B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.
p.000151: (p) COORDINATION OF FEDERAL PROGRAMS.—The Secretary shall coordinate the program carried out under
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p.000163: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 164
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p.000163: (i) measure progress toward achieving the out- come goals; and
p.000163: (ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency pre- paredness
p.000163: and response capabilities of the entity, and report to the Secretary on such measured and tested
p.000163: capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by
p.000163: the Secretary.
p.000163: (2) CRITERIA FOR PANDEMIC INFLUENZA PLANS.—
p.000163: (A) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards
p.000163: Pre- paredness Act, the Secretary shall develop and dissemi- nate to the chief executive officer of each State
p.000163: criteria for an effective State plan for responding to pandemic influ- enza. The Secretary shall periodically
p.000163: update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration
p.000163: of such criteria into the benchmarks and standards described in paragraph (1).
p.000163: (B) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to require the duplication of Federal ef-
p.000163: forts with respect to the development of criteria or stand- ards, without regard to whether such efforts
p.000163: were carried out prior to or after the date of enactment of this section.
p.000163: (3) TECHNICAL ASSISTANCE.—The Secretary shall, as deter- mined appropriate by the Secretary, provide to a
p.000163: State, upon request, technical assistance in meeting the requirements of this section, including the provision
p.000163: of advice by experts in the development of high-quality assessments, the setting of State objectives and
p.000163: assessment methods, the development of meas- ures of satisfactory annual improvement that are valid and re-
p.000163: liable, and other relevant areas.
p.000163: (4) NOTIFICATION OF FAILURES.—The Secretary shall de- velop and implement a process to notify entities that are
p.000163: deter- mined by the Secretary to have failed to meet the requirements of paragraph (1) or (2). Such process shall
p.000163: provide such entities with the opportunity to correct such noncompliance. An entity that fails to correct
p.000163: such noncompliance shall be subject to paragraph (5).
p.000163: (5) WITHHOLDING OF AMOUNTS FROM ENTITIES THAT FAIL TO ACHIEVE BENCHMARKS OR SUBMIT INFLUENZA
p.000163: PLAN.—Begin-
p.000163: ning with fiscal year 2019, and in each succeeding fiscal year, the Secretary shall—
...

p.000191: (D) TERMINATION.—The Advisory Committee termi- nates six years after the date of the enactment of the Pub- lic
p.000191: Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002.
p.000191: (3) EMERGENCY PUBLIC INFORMATION AND COMMUNICA- TIONS ADVISORY COMMITTEE.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the Emergency Public Information and Commu- nications Advisory Committee (referred to in this
p.000191: para- graph as the ‘‘EPIC Advisory Committee’’).
p.000191: (B) DUTIES.—The EPIC Advisory Committee shall make recommendations to the Secretary and report on ap-
p.000191: propriate ways to communicate public health information regarding bioterrorism and other public health
p.000191: emer- gencies to the public.
p.000191: (C) COMPOSITION.—The EPIC Advisory Committee shall be composed of individuals representing a diverse
p.000191: group of experts in public health, medicine, communica- tions, behavioral psychology, and other areas
p.000191: determined appropriate by the Secretary.
p.000191: (D) DISSEMINATION.—The Secretary shall review the recommendations of the EPIC Advisory Committee and en- sure
p.000191: that appropriate information is disseminated to the public.
p.000191: (E) TERMINATION.—The EPIC Advisory Committee ter- minates one year after the date of the enactment of Public Health
p.000191: Security and Bioterrorism Preparedness and Re- sponse Act of 2002.
p.000191: (c) EXPANSION OF EPIDEMIC INTELLIGENCE SERVICE PRO- GRAM.—The Secretary may establish 20 officer
p.000191: positions in the Epi- demic Intelligence Service Program, in addition to the number of the officer positions
p.000191: offered under such Program in 2006, for indi- viduals who agree to participate, for a period of not
p.000191: less than 2 years, in the Career Epidemiology Field Officer program in a State, local, or tribal health department
p.000191: that serves a health professional
p.000191: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000191:
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p.000193: PUBLIC HEALTH SERVICE ACT
p.000193: Sec. 319F
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p.000193: January 30, 2020
p.000193: shortage area (as defined under section 332(a)), a medically under- served population (as defined under section
p.000193: 330(b)(3)), or a medi- cally underserved area or area at high risk of a public health emer- gency as designated by
p.000193: the Secretary.
p.000193: (d) CENTERS FOR PUBLIC HEALTH PREPAREDNESS; CORE CUR-
p.000193: RICULA AND TRAINING.—
p.000193: (1) IN GENERAL.—The Secretary may establish at accred- ited schools of public health, Centers for Public
p.000193: Health Pre- paredness (hereafter referred to in this section as the ‘‘Cen- ters’’).
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p.000199: (B) the amount of which is not greater than
p.000199: $1,500,000.
p.000199: (2) SUBSEQUENT PHASES OF RESEARCH.—The Secretary’s determination of whether to employ expedited peer review
p.000199: with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section
p.000199: shall be deter- mined without regard to the peer review procedures used for any prior peer review of that
p.000199: same grant, contract, or coopera- tive agreement. Nothing in the preceding sentence may be con- strued to impose any
p.000199: requirement with respect to peer review not otherwise required under any other law or regulation.
p.000199: (d) AUTHORITY FOR PERSONAL SERVICES CONTRACTS.—
p.000199: (1) IN GENERAL.—For the purpose of performing, admin- istering, or supporting qualified countermeasure
p.000199: research and development activities, the Secretary may, as the Secretary de- termines necessary to respond to
p.000199: pressing qualified counter- measure research and development needs under this section, obtain by contract
p.000199: (in accordance with section 3109 of title 5, United States Code, but without regard to the limitations
p.000199: in such section on the period of service and on pay) the personal services of experts or consultants who have
p.000199: scientific or other professional qualifications, except that in no case shall the compensation provided to
p.000199: any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.
p.000199: (2) FEDERAL TORT CLAIMS ACT COVERAGE.—
p.000199: (A) IN GENERAL.—A person carrying out a contract under paragraph (1), and an officer, employee, or gov-
p.000199: erning board member of such person, shall, subject to a de- termination by the Secretary, be deemed to be an
p.000199: em- ployee of the Department of Health and Human Services for purposes of claims under sections 1346(b)
p.000199: and 2672 of title 28, United States Code, for money damages for per- sonal injury, including death,
p.000199: resulting from performance of functions under such contract.
p.000199: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000199:
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p.000199: Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 200
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p.000199: January 30, 2020
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p.000199: (B) EXCLUSIVITY OF REMEDY.—The remedy provided by subparagraph (A) shall be exclusive of any other civil ac-
p.000199: tion or proceeding by reason of the same subject matter against the entity involved (person, officer,
p.000199: employee, or governing board member) for any act or omission within the scope of the Federal Tort Claims Act.
p.000199: (C) RECOURSE IN CASE OF GROSS MISCONDUCT OR CON- TRACT VIOLATION.—
p.000199: (i) IN GENERAL.—Should payment be made by the United States to any claimant bringing a claim under this paragraph,
p.000199: either by way of administrative deter- mination, settlement, or court judgment, the United States shall have,
p.000199: notwithstanding any provision of State law, the right to recover against any entity iden- tified in subparagraph (B)
p.000199: for that portion of the dam- ages so awarded or paid, as well as interest and any costs of litigation,
p.000199: resulting from the failure of any such entity to carry out any obligation or responsi- bility assumed by
p.000199: such entity under a contract with the United States or from any grossly negligent or reckless conduct
p.000199: or intentional or willful misconduct on the part of such entity.
p.000199: (ii) VENUE.—The United States may maintain an action under this subparagraph against such entity in the district
p.000199: court of the United States in which such entity resides or has its principal place of business.
p.000199: (3) INTERNAL CONTROLS TO BE INSTITUTED.—
p.000199: (A) IN GENERAL.—The Secretary shall institute appro- priate internal controls for contracts under this
p.000199: subsection, including procedures for the Secretary to make a deter- mination of whether a person, or an
p.000199: officer, employee, or governing board member of a person, is deemed to be an employee of the Department
p.000199: of Health and Human Serv- ices pursuant to paragraph (2).
p.000199: (B) DETERMINATION OF EMPLOYEE STATUS TO BE FINAL.—A determination by the Secretary under
p.000199: subpara- graph (A) that a person, or an officer, employee, or gov- erning board member of a person, is
p.000199: or is not deemed to be an employee of the Department of Health and Human Services shall be final and
p.000199: binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.
p.000199: (4) NUMBER OF PERSONAL SERVICES CONTRACTS LIMITED.— The number of experts and consultants whose personal
p.000199: serv- ices are obtained under paragraph (1) shall not exceed 30 at any time.
p.000199: (e) STREAMLINED PERSONNEL AUTHORITY.—
p.000199: (1) IN GENERAL.—In addition to any other personnel au- thorities, the Secretary may, as the Secretary
p.000199: determines nec- essary to respond to pressing qualified countermeasure re- search and development needs
p.000199: under this section, without re- gard to those provisions of title 5, United States Code, gov- erning
p.000199: appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000199: subchapter III of
p.000199: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: PUBLIC HEALTH SERVICE ACT
p.000201: Sec. 319F–2
p.000201:
p.000201: chapter 53 of such title relating to classification and General Schedule pay rates, appoint professional and
p.000201: technical employ- ees, not to exceed 30 such employees at any time, to positions in the National Institutes of Health
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p.000233: another State and have not been disciplined by any State health licensing or discipli- nary board. In order to
p.000233: inform the development of such mecha- nisms by States, the Secretary shall make available information and
p.000233: material provided by States that have developed mechanisms to waive the application of licensing
p.000233: requirements to applicable health professionals seeking to provide medical services during a public health
p.000233: emergency. Such information shall be made publicly available in a manner that does not compromise national
p.000233: security.
p.000233: (j) RULE OF CONSTRUCTION.—This section may not be con-
p.000233: strued as authorizing the Secretary to issue requirements regard- ing the provision by the States of
p.000233: credentials, licenses, accredita- tions, or hospital privileges.
p.000233: (k) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000233: to be appropriated
p.000233: $5,000,000 for each of fiscal years 2019 through 2023.
p.000233: SEC. 319J. ø247d–7c¿ SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
p.000233: (a) IN GENERAL.—Upon the request of a recipient of an award under any of sections 319 through 319I or section
p.000233: 319K, the Sec- retary may, subject to subsection (b), provide supplies, equipment, and services for the
p.000233: purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such
p.000233: purposes, may detail to the recipient any officer or employee of the Depart- ment of Health and Human
p.000233: Services.
p.000233: (b) CORRESPONDING REDUCTION IN PAYMENTS.—With respect to a request described in subsection (a), the Secretary shall
p.000233: reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the
p.000233: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for
p.000233: the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.000233: SEC. 319K. ø247d–7d¿ SECURITY FOR COUNTERMEASURE DEVELOP- MENT AND PRODUCTION.
p.000233: (a) IN GENERAL.—The Secretary, in consultation with the At- torney General and the Secretary of Defense, may
p.000233: provide technical or other assistance to provide security to persons or facilities that conduct development,
p.000233: production, distribution, or storage of priority countermeasures (as defined in section 319F(e)(4)).
p.000233: (b) GUIDELINES.—The Secretary may develop guidelines to en- able entities eligible to receive assistance
p.000233: under subsection (a) to secure their facilities against potential terrorist attack.
p.000233: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000235: PUBLIC HEALTH SERVICE ACT
p.000235: Sec. 319L
p.000235:
p.000235: SEC. 319L. ø247d–7e¿ BIOMEDICAL ADVANCED RESEARCH AND DEVEL- OPMENT AUTHORITY.
p.000235: (a) DEFINITIONS.—In this section:
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p.000253: burial expenses for, any patient dying in a hospital or station.
p.000253:
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p.000253: January 30, 2020
p.000253:
p.000253: CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN OTHER PERSONS
p.000253: SEC. 322. ø249¿ (a) Any person when detained in accordance with quarantine laws, or, at the request of
p.000253: the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for
p.000253: by the Public Health Service.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000255: PUBLIC HEALTH SERVICE ACT
p.000255: Sec. 324
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p.000255: (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in
p.000255: accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in
p.000255: case of emergency.
p.000255: (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with
p.000255: regulations, receive such care and treatment at the expense of the Service from public or private medical or
p.000255: hospital facilities other than those of the Service, when authorized by the officer in charge of the station
p.000255: at which the ap- plication is made.
p.000255: CARE AND TREATMENT OF FEDERAL PRISONERS 27
p.000255: SEC. 323. ø250¿ The Service shall supervise and furnish med- ical treatment and other necessary medical,
p.000255: psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended
p.000255: (U.S.C., 1940 edition, title 18, secs. 751, 752), 28 in penal and correctional institutions of the United
p.000255: States.
p.000255: EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES
p.000255: SEC. 324. ø251¿ (a) The Surgeon General is authorized to pro- vide at institutions, hospitals, and stations of
p.000255: the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under
p.000255: the United States Employees’ Compensation Act 29 and extensions thereof. The Surgeon General may also provide
p.000255: for making medical examinations of—
p.000255: (1) employees of the Federal Government for retirement purposes;
p.000255: (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service
p.000255: Commission for the purpose of promoting health and efficiency;
p.000255: (3) seamen for purposes of qualifying for certificates of service; and
p.000255: (4) employees eligible for benefits under the Longshore- men’s and Harbor Workers’ Compensation Act, as
...

p.000255: preceding sentence shall be credited to the applicable appropriation to the Public Health Service for the year
p.000255: in which such payments are received.
p.000255: EXAMINATION OF ALIENS
p.000255: SEC. 325. ø252¿ The Surgeon General shall provide for mak- ing, at places within the United States or
p.000255: in other countries, such physical and mental examinations of aliens as are required by the immigration laws,
p.000255: subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the
p.000255: Surgeon General with the approval of the Secretary.
p.000255: SERVICES TO COAST GUARD, COAST AND GEODETIC SURVEY, AND PUBLIC HEALTH SERVICE
p.000255: SEC. 326. ø253¿ (a) Subject to regulations of the President—
p.000255: (1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the
p.000255: Regular Coast Guard on active duty, including those on shore duty and those on detached duty; and Regular and
p.000255: temporary members of the United States Coast Guard Reserve when on active duty;
p.000255: (2) commissioned officers, ships’ officers, and members of the crews of vessels of the United States
p.000255: Coast and Geodetic Survey on active duty including those on shore duty and those on detached duty; and
p.000255: (3) commissioned officers of the Regular or Reserve Corps of the Public Health Service on active duty;
p.000255: shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service. The
p.000255: Surgeon General may detail commissioned officers for duty aboard vessels of the Coast Guard or the Coast
p.000255: and Geodetic Survey.
p.000255: (b)(1) The Secretary may provide health care for an officer of the Regular or Reserve Corps
p.000255: involuntarily separated from the Service, and for any dependent of such officer, if—
p.000255: (A) the officer or dependent was receiving health care at the expense of the Service at the time of
p.000255: the separation; and
p.000255: (B) the Secretary finds that the officer or dependent is un- able to obtain appropriate insurance for the
p.000255: conditions for which the officer or dependent was receiving health care.
p.000255: (2) Health care may be provided under paragraph (1) for a pe- riod of not more than one year from the date of
p.000255: separation of the officer from the Service.
p.000255: (c) The Service shall provide all services referred to in sub- section (a) required by the Coast Guard or
p.000255: Coast and Geodetic Sur- vey and shall perform all duties prescribed by statute in connection with the examinations
p.000255: to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, pro-
p.000255: motion and retirement, and officers of the Service assigned to duty on Coast Guard or Coast and Geodetic Survey
p.000255: vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
p.000255:
p.000255: January 30, 2020 As Amended Through P.L. 116-94,
p.000255: Enacted December 20, 2019
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p.000257: PUBLIC HEALTH SERVICE ACT
p.000257: Sec. 330
p.000257:
p.000257: INTERDEPARTMENTAL WORK
p.000257: SEC. 327. ø254¿ Nothing contained in this part shall affect the authority of the Service to furnish any
p.000257: materials, supplies, or equipment, or perform any work or services, requested in accord- ance with section 7
p.000257: of the Act of May 21, 1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or the authority of any other execu-
p.000257: tive department to furnish any materials, supplies, or equipment, or perform any work or services,
...

p.000259:
p.000259:
p.000259: January 30, 2020
p.000259: and
p.000259: (D) in the case of health centers receiving grants under subsection (g), special
p.000259: occupation-related health services for migratory and seasonal agricultural workers, including—
p.000259: (i) screening for and control of infectious diseases, including parasitic diseases; and
p.000259: (ii) injury prevention programs, including preven- tion of exposure to unsafe levels of agricultural chemi- cals
p.000259: including pesticides.
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: Sec. 330 PUBLIC HEALTH SERVICE ACT 260
p.000259:
p.000259: (3) MEDICALLY UNDERSERVED POPULATIONS.—
p.000259: (A) IN GENERAL.—The term ‘‘medically underserved population’’ means the population of an urban or rural
p.000259: area designated by the Secretary as an area with a short- age of personal health services or a population group
p.000259: des- ignated by the Secretary as having a shortage of such serv- ices.
p.000259: (B) CRITERIA.—In carrying out subparagraph (A), the Secretary shall prescribe criteria for determining the
p.000259: spe- cific shortages of personal health services of an area or population group. Such criteria shall—
p.000259: (i) take into account comments received by the Secretary from the chief executive officer of a State and
p.000259: local officials in a State; and
p.000259: (ii) include factors indicative of the health status of a population group or residents of an area, the abil-
p.000259: ity of the residents of an area or of a population group to pay for health services and their accessibility to
p.000259: them, and the availability of health professionals to residents of an area or to a population group.
p.000259: (C) LIMITATION.—The Secretary may not designate a medically underserved population in a State or terminate
p.000259: the designation of such a population unless, prior to such designation or termination, the Secretary provides
p.000259: reason- able notice and opportunity for comment and consults with—
p.000259: (i) the chief executive officer of such State;
p.000259: (ii) local officials in such State; and
p.000259: (iii) the organization, if any, which represents a majority of health centers in such State.
p.000259: (D) PERMISSIBLE DESIGNATION.—The Secretary may designate a medically underserved population that does
p.000259: not meet the criteria established under subparagraph (B) if the chief executive officer of the State in which
p.000259: such pop- ulation is located and local officials of such State rec- ommend the designation of such
p.000259: population based on un- usual local conditions which are a barrier to access to or the availability of
p.000259: personal health services.
p.000259: (c) PLANNING GRANTS.—
p.000259: (1) CENTERS.—The Secretary may make grants to public and nonprofit private entities for projects to plan
p.000259: and develop health centers which will serve medically underserved popu- lations. A project for which a
p.000259: grant may be made under this subsection may include the cost of the acquisition and lease of buildings and
p.000259: equipment (including the costs of amortizing the principal of, and paying the interest on, loans) and shall
p.000259: in- clude—
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p.000259: January 30, 2020
p.000259: (A) an assessment of the need that the population pro- posed to be served by the health center for which the
p.000259: project is undertaken has for required primary health services and additional health services;
p.000259: (B) the design of a health center program for such pop- ulation based on such assessment;
p.000259: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000261: PUBLIC HEALTH SERVICE ACT
p.000261: Sec. 330
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p.000303: services in a health professional shortage area in accordance with a service obligation incurred under the
p.000303: Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may
p.000303: be made for such a member only upon satisfactory completion of such serv- ice obligation, and the first 36
p.000303: months of such member’s being so engaged in the delivery of health services shall, for purposes of
p.000303: paragraph (1)(A), be deemed to begin upon such satisfactory com- pletion.
p.000303: (3) A member of the Corps described in subparagraph (C) of subsection (a)(1) shall when assigned to an entity
p.000303: under section 333 be subject to the personnel system of such entity, except that such member shall receive during
p.000303: the period of assignment the income that the member would receive if the member was a member of the Corps
p.000303: described in subparagraph (B) of such subsection.
p.000303: (e) Corps members assigned under section 333 to provide health services in health professional
p.000303: shortage areas shall not be counted against any employment ceiling affecting the Department.
p.000303: (f) Sections 214 and 216 shall not apply to members of the Na- tional Health Service Corps during their period of
p.000303: obligated service under the Scholarship Program or the Loan Repayment Program, except when such members are
p.000303: Commissioned Corps officers who entered into a contract with Secretary under section 338A or 338B after December
p.000303: 31, 2006 and when the Secretary determines that exercising the authority provided under section 214 or 216 with
p.000303: re- spect to any such officer to would not cause unreasonable disrup-
p.000303: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000305: PUBLIC HEALTH SERVICE ACT
p.000305: Sec. 331
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p.000305: January 30, 2020
p.000305: tion to health care services provided in the community in which such officer is providing health care
p.000305: services.
p.000305: (g)(1) The Secretary shall, by rule, prescribe conversion provi- sions applicable to any individual who, within
p.000305: a year after comple- tion of service as a member of the Corps described in subsection (a)(1)(C), becomes a
p.000305: commissioned officer in the Regular or Reserve Corps of the Service.
p.000305: (2) The rules prescribed under paragraph (1) shall provide that in applying the appropriate provisions of this
p.000305: Act which relate to retirement, any individual who becomes such an officer shall be en- titled to have credit
p.000305: for any period of service as a member of the Corps described in subsection (a)(1)(C).
p.000305: (h) The Secretary shall ensure that adequate staff is provided to the Service with respect to effectively
p.000305: administering the program for the Corps.
p.000305: (i)(1) In carrying out subpart III, the Secretary may, in accord- ance with this subsection, issue waivers to
p.000305: individuals who have entered into a contract for obligated service under the Scholarship Program or the Loan
p.000305: Repayment Program under which the individ- uals are authorized to satisfy the requirement of obligated service
p.000305: through providing clinical practice that is half time.
p.000305: (2) A waiver described in paragraph (1) may be provided by the Secretary only if—
p.000305: (A) the entity for which the service is to be performed—
p.000305: (i) has been approved under section 333A for assign- ment of a Corps member; and
p.000305: (ii) has requested in writing assignment of a health professional who would serve half time;
p.000305: (B) the Secretary has determined that assignment of a health professional who would serve half time would be
p.000305: appro- priate for the area where the entity is located;
p.000305: (C) a Corps member who is required to perform obligated service has agreed in writing to be assigned for
p.000305: half-time serv- ice to an entity described in subparagraph (A);
p.000305: (D) the entity and the Corps member agree in writing that the Corps member will perform half-time clinical practice;
p.000305: (E) the Corps member agrees in writing to fulfill all of the service obligations under section 338C through
p.000305: half-time clin- ical practice and either—
p.000305: (i) double the period of obligated service that would otherwise be required; or
...

p.000307: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000307: Sec. 332 PUBLIC HEALTH SERVICE ACT 308
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p.000307: January 30, 2020
p.000307:
p.000307: States, publish a descriptive list of the areas, population groups, medical facilities, and other public
p.000307: facilities so designated, and at least annually review and, as necessary, revise such designations.
p.000307: (2) For purposes of paragraph (1), a complete descriptive list shall be published in the Federal Register not
p.000307: later than July 1 of 1991 and each subsequent year.
p.000307: (e)(1) Prior to the designation of a public facility, including a Federal medical facility, as a health
p.000307: professional shortage area, the Secretary shall give written notice of such proposed designation to the chief
p.000307: administrative officer of such facility and request com- ments within 30 days with respect to such designation.
p.000307: (2) Prior to the designation of a health professional shortage area under this section, the Secretary
p.000307: shall, to the extent prac- ticable, give written notice of the proposed designation of such area to appropriate
p.000307: public or private nonprofit entities which are located or have a demonstrated interest in such area and
p.000307: request com- ments from such entities with respect to the proposed designation of such area.
p.000307: (f) The Secretary shall give written notice of the designation of a health professional shortage area, not later
p.000307: than 60 days from the date of such designation, to—
p.000307: (1) the Governor of each State in which the area, popu- lation group, medical facility, or other public
p.000307: facility so des- ignated is in whole or part located; and
p.000307: (2) appropriate public or nonprofit private entities which are located or which have a demonstrated interest in
p.000307: the area so designated.
p.000307: (g) Any person may recommend to the Secretary the designa- tion of an area, population group, medical
p.000307: facility, or other public facility as a health professional shortage area.
p.000307: (h) The Secretary may conduct such information programs in areas, among population groups, and in medical
p.000307: facilities and other public facilities designated under this section as health professional shortage areas as may be
p.000307: necessary to inform public and nonprofit private entities which are located or have a demonstrated interest in
p.000307: such areas of the assistance available under this title by virtue of the designation of such areas.
...

p.000321:
p.000321: Subpart III—Scholarship Program and Loan Repayment Program
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p.000321: January 30, 2020
p.000321: NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP PROGRAM
p.000321: SEC. 338A. ø254l¿ (a) The Secretary shall establish the Na- tional Health Service Corps Scholarship
p.000321: Program to assure, with respect to the provision of primary health services pursuant to sec- tion 331(a)(2)—
p.000321: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000321: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000321: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000321: (b) To be eligible to participate in the Scholarship Program, an individual must—
p.000321: (1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by
p.000321: the Secretary) educational institution in a State and (B) in a course of study or program, offered by
p.000321: such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medi- cine,
p.000321: dentistry, or other health profession, or an appropriate degree from a graduate program of behavioral and
p.000321: mental health;
p.000321: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000321: Corps of the Service or be eligible for selection for civilian service in the Corps;
p.000321: (3) submit an application to participate in the Scholarship Program; and
p.000321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000323: PUBLIC HEALTH SERVICE ACT
p.000323: Sec. 338A
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p.000323: January 30, 2020
p.000323: (4) sign and submit to the Secretary, at the time of sub- mittal of such application, a written contract
p.000323: (described in sub- section (f)) to accept payment of a scholarship and to serve (in accordance with this subpart) for
p.000323: the applicable period of obli- gated service in a health professional shortage area.
p.000323: (c)(1) In disseminating application forms and contract forms to individuals desiring to participate in the Scholarship
p.000323: Program, the Secretary shall include with such forms—
...

p.000325: SEC. 338B. ø254l–1¿ NATIONAL HEALTH SERVICE CORPS LOAN REPAY- MENT PROGRAM.
p.000325: (a) ESTABLISHMENT.—The Secretary shall establish a program to be known as the National Health Service Corps
p.000325: Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to section
p.000325: 331(a)(2)—
p.000325: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000325: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000325: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000325: (b) ELIGIBILITY.—To be eligible to participate in the Loan Re- payment Program, an individual must—
p.000325: (1)(A) have a degree in medicine, osteopathic medicine, dentistry, or another health profession, or an
p.000325: appropriate de- gree from a graduate program of behavioral and mental health, or be certified as a nurse midwife,
p.000325: nurse practitioner, or physi- cian assistant;
p.000325: (B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry,
p.000325: behavioral and mental health, or other health profession; or
p.000325: (C) be enrolled as a full-time student—
p.000325: (i) in an accredited (as determined by the Secretary) educational institution in a State; and
p.000325: (ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary,
p.000325: leading to a degree in medicine, osteopathic medicine, den- tistry, or other health profession;
p.000325: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000325: Corps of the Service or be eligible for selection for civilian service in the Corps; and
p.000325: (3) submit to the Secretary an application for a contract described in subsection (f) (relating to the payment
p.000325: by the Sec- retary of the educational loans of the individual in consider- ation of the individual serving for
p.000325: a period of obligated service).
p.000325: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000327: PUBLIC HEALTH SERVICE ACT
p.000327: Sec. 338B
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p.000327: (c) APPLICATION, CONTRACT, AND INFORMATION REQUIRE-
p.000327: MENTS.—
p.000327: (1) SUMMARY AND INFORMATION.—In disseminating appli- cation forms and contract forms to individuals desiring to
p.000327: par- ticipate in the Loan Repayment Program, the Secretary shall include with such forms—
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p.000331: 331
p.000331: PUBLIC HEALTH SERVICE ACT
p.000331: Sec. 338C
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p.000331: January 30, 2020
p.000331: teaching by such member may be counted toward his or her service obligation.
p.000331: (b)(1) If an individual is required under subsection (a) to pro- vide service as specified in
p.000331: section 338A(f)(1)(B)(v) or 338B(f)(1)(B)(iv) (hereinafter in this subsection referred to as ‘‘obli- gated
p.000331: service’’), the Secretary shall, not later than ninety days be- fore the date described in paragraph
p.000331: (5), determine if the indi- vidual shall provide such service—
p.000331: (A) as a member of the Corps who is a commissioned offi- cer in the Regular or Reserve Corps of the Service
p.000331: or who is a civilian employee of the United States, or
p.000331: (B) as a member of the Corps who is not such an officer or employee,
p.000331: and shall notify such individual of such determination.
p.000331: (2) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is a
p.000331: commissioned officer in the Service or a civilian employee of the United States, the Secretary shall, not
p.000331: later than sixty days before the date de- scribed in paragraph (5), provide such individual with sufficient in-
p.000331: formation regarding the advantages and disadvantages of service as such a commissioned officer or civilian
p.000331: employee to enable the individual to make a decision on an informed basis. To be eligible to provide
p.000331: obligated service as a commissioned officer in the Serv- ice, an individual shall notify the Secretary,
p.000331: not later than thirty days before the date described in paragraph (5), of the individual’s desire to provide such
p.000331: service as such an officer. If an individual qualifies for an appointment as such an officer, the Secretary
p.000331: shall, as soon as possible after the date described in paragraph (5), ap- point the individual as a
p.000331: commissioned officer of the Regular or Re- serve Corps of the Service and shall designate the individual as
p.000331: a member of the Corps.
p.000331: (3) If an individual provided notice by the Secretary under paragraph (2) does not qualify for appointment as
p.000331: a commissioned officer in the Service, the Secretary shall, as soon as possible after the date described in
p.000331: paragraph (5), appoint such individual as a civilian employee of the United States and designate the individual
p.000331: as a member of the Corps.
p.000331: (4) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is not
p.000331: an employee of the United States, the Secretary shall, as soon as possible after the date described in paragraph
p.000331: (5), designate such individual as a member of the Corps to provide such service.
p.000331: (5)(A) In the case of the Scholarship Program, the date referred to in paragraphs (1) through (4) shall be the date on
p.000331: which the in- dividual completes the training required for the degree for which the individual receives the
p.000331: scholarship, except that—
p.000331: (i) for an individual receiving such a degree after Sep- tember 30, 2000, from a school of medicine or
p.000331: osteopathic medi- cine, such date shall be the date the individual completes a residency in a specialty
p.000331: that the Secretary determines is con- sistent with the needs of the Corps; and
p.000331: (ii) at the request of an individual, the Secretary may, con- sistent with the needs of the Corps, defer such
p.000331: date until the
p.000331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000331:
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p.000331: Sec. 338D PUBLIC HEALTH SERVICE ACT 332
p.000331:
p.000331: end of a period of time required for the individual to complete advanced training (including an internship or
p.000331: residency).
p.000331: (B) No period of internship, residency, or other advanced clin- ical training shall be counted toward
p.000331: satisfying a period of obli- gated service under this subpart.
p.000331: (C) In the case of the Loan Repayment Program, if an indi- vidual is required to provide obligated service
p.000331: under such Program, the date referred to in paragraphs (1) through (4)—
p.000331: (i) shall be the date determined under subparagraph (A) in the case of an individual who is enrolled in the
p.000331: final year of a course of study;
p.000331: (ii) shall, in the case of an individual who is enrolled in an approved graduate training program in medicine,
p.000331: osteopathic medicine, dentistry, or other health profession, be the date the individual completes such training
p.000331: program; and
p.000331: (iii) shall, in the case of an individual who has a degree in medicine, osteopathic medicine, dentistry,
p.000331: or other health profession and who has completed graduate training, be the date the individual enters
p.000331: into an agreement with the Sec- retary under section 338B.
p.000331: (c) An individual shall be considered to have begun serving a period of obligated service—
p.000331: (1) on the date such individual is appointed as an officer in a Regular or Reserve Corps of the
p.000331: Service or is designated as a member of the Corps under subsection (b)(3) or (b)(4), or
p.000331: (2) in the case of an individual who has entered into an agreement with the Secretary under section 338D, on
p.000331: the date specified in such agreement,
p.000331: whichever is earlier.
p.000331: (d) The Secretary shall assign individuals performing obligated service in accordance with a written contract under the
p.000331: Scholarship Program to health professional shortage areas in accordance with sections 331 through 335 and
p.000331: sections 337 and 338. If the Sec- retary determines that there is no need in a health professional
p.000331: shortage area (designated under section 332) for a member of the profession in which an individual is
p.000331: obligated to provide service under a written contract and if such individual is an officer in the Service or a
p.000331: civilian employee of the United States, the Secretary may detail such individual to serve his period of
p.000331: obligated service as a full-time member of such profession in such unit of the De- partment as the
p.000331: Secretary may determine.
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p.000331: January 30, 2020
p.000331:
p.000331: PRIVATE PRACTICE
p.000331: SEC. 338D. ø254n¿ (a) The Secretary shall, to the extent per- mitted by, and consistent with, the
p.000331: requirements of applicable State law, release an individual from all or part of his service obli- gation under
p.000331: section 338C(a) or under section 225 (as in effect on September 30, 1977) if the individual applies for
p.000331: such a release under this section and enters into a written agreement with the Secretary under which the
p.000331: individual agrees to engage for a period equal to the remaining period of his service obligation in the
p.000331: full- time private clinical practice (including service as a salaried em-
p.000331: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000333: 333
p.000333: PUBLIC HEALTH SERVICE ACT
p.000333: Sec. 338D
p.000333:
p.000333: ployee in an entity directly providing health services) of his health profession—
p.000333: (1) in the case of an individual who received a scholarship under the Scholarship Program or a loan repayment under the
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p.000343: January 30, 2020
p.000343: Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the Northern Mariana Islands.
p.000343: (i) AUTHORIZATION OF APPROPRIATIONS.—
p.000343: (1) IN GENERAL.—For the purpose of making grants under subsection (a), there are authorized to be
p.000343: appropriated
p.000343: $12,000,000 for fiscal year 2008, and such sums as may be nec- essary for each of fiscal years 2009 through 2012.
p.000343: (2) AVAILABILITY.—Amounts appropriated under paragraph
p.000343: (1) shall remain available until expended.
p.000343: (j) PUBLIC HEALTH LOAN REPAYMENT.—
p.000343: (1) IN GENERAL.—The Secretary may award grants to States for the purpose of assisting such States
p.000343: in operating loan repayment programs under which such States enter into contracts to repay all or part of the
p.000343: eligible loans borrowed by, or on behalf of, individuals who agree to serve in State, local, or tribal
p.000343: health departments that serve health professional shortage areas or other areas at risk of a public
p.000343: health emer- gency, as designated by the Secretary.
p.000343: (2) LOANS ELIGIBLE FOR REPAYMENT.—To be eligible for re- payment under this subsection, a loan shall be a
p.000343: loan made, insured, or guaranteed by the Federal Government that is bor- rowed by, or on behalf of, an
p.000343: individual to pay the cost of at- tendance for a program of education leading to a degree appro- priate for
p.000343: serving in a State, local, or tribal health department as determined by the Secretary and the chief executive
p.000343: officer of the State in which the grant is administered, at an institu- tion of higher education (as defined in section
p.000343: 102 of the High- er Education Act of 1965), including principal, interest, and re- lated expenses on such loan.
p.000343: (3) APPLICABILITY OF EXISTING REQUIREMENTS.—With re- spect to awards made under paragraph (1)—
p.000343: (A) the requirements of subsections (b), (f), and (g) shall apply to such awards; and
p.000343: (B) the requirements of subsection (c) shall apply to such awards except that with respect to paragraph
p.000343: (1) of such subsection, the State involved may assign an indi- vidual only to public and nonprofit
p.000343: private entities that serve health professional shortage areas or areas at risk of a public health emergency, as
p.000343: determined by the Sec- retary.
p.000343: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000343: sums as may be necessary for each of fiscal years 2007 through 2010.
p.000343: SEC. 338J. ø254r¿ GRANTS TO STATE OFFICES OF RURAL HEALTH.
p.000343: (a) IN GENERAL.—The Secretary, acting through the Director of the Federal Office of Rural Health Policy (established
p.000343: under section 711 of the Social Security Act), shall make grants to each State Of- fice of Rural Health for the
p.000343: purpose of improving health care in rural areas.
p.000343: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000343: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless the
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p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
p.000377: (2) ASSURANCES.—The application shall include assurances that the State will meet the requirements of subsection (d)
p.000377: and that the State possesses sufficient infrastructure to manage the activities to be funded through the
p.000377: grant and to evaluate and report on the outcomes resulting from such activities.
p.000377: (d) MATCHING REQUIREMENT.—The Secretary may not make a grant to a State under this section unless that
p.000377: State agrees that, with respect to the costs to be incurred by the State in carrying out the activities for which the
p.000377: grant was awarded, the State will pro- vide non-Federal contributions in an amount equal to not less than 40 percent
p.000377: of Federal funds provided under the grant. The State
p.000377: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000379: PUBLIC HEALTH SERVICE ACT
p.000379: Sec. 340G–1
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p.000387: January 30, 2020
p.000387:
p.000387: (D) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; RISK EVALUATION AND MITIGATION STRATEGY.—A person
p.000387: that sub- mits an application for a license under this paragraph is subject to sections 505(o), 505(p), and 505–1
p.000387: of the Federal Food, Drug, and Cosmetic Act.
p.000387: (E)(i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental
p.000387: application, with respect to a qualified indication for a drug, submitted under this sub- section, if such
p.000387: supplemental application complies with the require- ments of subparagraph (B) of section 505(c)(5) of the Federal Food,
p.000387: Drug, and Cosmetic Act.
p.000387: (ii) In this subparagraph, the terms ‘‘qualified indication’’ and ‘‘qualified data summary’’ have the
p.000387: meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.
p.000387: (3) The Secretary shall prescribe requirements under which a biological product undergoing investigation
p.000387: shall be exempt from the requirements of paragraph (1).
p.000387: (b) No person shall falsely label or mark any package or con- tainer of any biological product or
p.000387: alter any label or mark on the package or container of the biological product so as to falsify the
p.000387: label or mark.
p.000387: (c) Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the
p.000387: purpose, may during all reasonable hours enter and inspect any establish- ment for the propagation or
p.000387: manufacture and preparation of any biological product.
p.000387: (d)(1) Upon a determination that a batch, lot, or other quantity of a product licensed under this section
p.000387: presents an imminent or substantial hazard to the public health, the Secretary shall issue an order
p.000387: immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this
p.000387: paragraph shall be issued in accordance with section 554 of title 5, United States Code.
p.000387: (2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per
p.000387: day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year
p.000387: beginning 1 year after the effective date of this para- graph, be increased by the percent change in the
p.000387: Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base
p.000387: quarter of the preceding year, adjusted to the nearest 1⁄10 of 1 percent. For purposes of this paragraph, the
p.000387: term ‘‘base quarter’’, as used with respect to a year, means the calendar quarter ending on September 30 of such
p.000387: year and the price index for a base quarter is the arithmetical mean of such index for the 3 months
p.000387: comprising such quarter.
p.000387: (e) No person shall interfere with any officer, agent, or em- ployee of the Service in the performance of any
p.000387: duty imposed upon him by this section or by regulations made by authority thereof.
p.000387: (f) Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be
p.000387: punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such
p.000387: fine and imprisonment, in the discretion of the court.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000387:
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p.000389: PUBLIC HEALTH SERVICE ACT
p.000389: Sec. 351
p.000389:
p.000389: (g) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding
p.000389: the provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 1940 edition, title 21, ch. 9). 58
p.000389: (h) 59 A partially processed biological product which—
p.000389: (1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
p.000389: (2) is not intended for sale in the United States; and
p.000389: (3) is intended for further manufacture into final dosage form outside the United States,
p.000389: shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and
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p.000419: (B) has performed or represented the laboratory as en- titled to perform a laboratory examination or other
p.000419: proce- dure which is not within a category of laboratory examina- tions or other procedures authorized in the
p.000419: certificate,
p.000419: (C) has failed to comply with the requirements of sub- section (d) or the standards prescribed by the Secretary
p.000419: under subsection (f),
p.000419: (D) has failed to comply with reasonable requests of the Secretary for—
p.000419: (i) any information or materials, or
p.000419: (ii) work on materials,
p.000419: that the Secretary concludes is necessary to determine the laboratory’s continued eligibility for its certificate
p.000419: or con- tinued compliance with the Secretary’s standards under subsection (f),
p.000419: (E) has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by
p.000419: the Secretary, for permission to inspect the laboratory and its operations and pertinent records during the hours the
p.000419: lab- oratory is in operation,
p.000419: (F) has violated or aided and abetted in the violation of any provisions of this section or of any
p.000419: regulation pro- mulgated thereunder, or
p.000419: (G) has not complied with an intermediate sanction imposed under subsection (h).
p.000419: (2) ACTION BEFORE A HEARING.—If the Secretary deter- mines that—
p.000419: (A) the failure of a laboratory to comply with the standards of the Secretary under subsection (f) presents an
p.000419: imminent and serious risk to human health, or
p.000419: (B) a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1),
p.000419: the Secretary may suspend or limit the certificate of the lab- oratory before holding a hearing under
p.000419: paragraph (1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later
p.000419: than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this
p.000419: paragraph shall stay in effect until the decision of the Sec- retary made after the hearing under paragraph
p.000419: (1).
p.000419: (3) INELIGIBILITY TO OWN OR OPERATE LABORATORIES AFTER REVOCATION.—No person who has owned or operated a labora-
p.000419: tory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a
p.000419: laboratory for which a certificate has been issued under this section, ex- cept that if the revocation occurs
p.000419: pursuant to paragraph (4) the Secretary may substitute intermediate sanctions under sub- section (h) instead of
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p.000421: January 30, 2020
p.000421: (4) IMPROPER REFERRALS.—Any laboratory that the Sec- retary determines intentionally refers its proficiency
p.000421: testing samples to another laboratory for analysis may have its certifi- cate revoked for at least one year and shall
p.000421: be subject to appro- priate fines and penalties as provided for in subsection (h).
p.000421: (j) INJUNCTIONS.—Whenever the Secretary has reason to be- lieve that continuation of any activity by a
p.000421: laboratory would con- stitute a significant hazard to the public health the Secretary may bring suit in the district
p.000421: court of the United States for the district in which such laboratory is situated to enjoin continuation of such
p.000421: activity. Upon proper showing, a temporary injunction or restrain- ing order against continuation of such activity
p.000421: pending issuance of a final order under this subsection shall be granted without bond by such court.
p.000421: (k) JUDICIAL REVIEW.—
p.000421: (1) PETITION.—Any laboratory which has had an inter- mediate sanction imposed under subsection (h) or has
p.000421: had its certificate suspended, revoked, or limited under subsection (i) may, at any time within 60 days
p.000421: after the date the action of the Secretary under subsection (i) or (h) becomes final, file a petition
p.000421: with the United States court of appeals for the circuit wherein the laboratory has its principal place of
p.000421: business for judicial review of such action. As soon as practicable after re- ceipt of the petition, the
p.000421: clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the
p.000421: Secretary for that purpose. As soon as practicable after receipt of the copy, the Secretary shall file in the
p.000421: court the record on which the action of the Secretary is based, as pro- vided in section 2112 of title 28,
p.000421: United States Code.
p.000421: (2) ADDITIONAL EVIDENCE.—If the petitioner applies to the court for leave to adduce additional evidence, and shows to
p.000421: the satisfaction of the court that such additional evidence is mate- rial and that there were reasonable grounds
p.000421: for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such
p.000421: additional evidence (and evidence in rebuttal of such additional evidence) to be taken before the Secretary,
p.000421: and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem
p.000421: proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by
p.000421: reason of the addi- tional evidence so taken, and the Secretary shall file such modified or new findings,
p.000421: and the recommendations of the Sec- retary, if any, for the modification or setting aside of his origi- nal action,
p.000421: with the return of such additional evidence.
p.000421: (3) JUDGMENT OF COURT.—Upon the filing of the petition referred to in paragraph (1), the court shall
p.000421: have jurisdiction to affirm the action, or to set it aside in whole or in part, tem- porarily or permanently. The
p.000421: findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclu- sive.
p.000421: (4) FINALITY OF JUDGMENT.—The judgment of the court af- firming or setting aside, in whole or in part, any
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p.000431: oversee quality assurance practices at mammography facilities.
p.000431: (g) INSPECTIONS.—
p.000431: (1) ANNUAL INSPECTIONS.—
p.000431: (A) IN GENERAL.—The Secretary may enter and in- spect facilities to determine compliance with the
p.000431: certifi- cation requirements under subsection (b) and the stand- ards established under subsection (f). The
p.000431: Secretary shall, if feasible, delegate to a State or local agency the authority to make such inspections.
p.000431: (B) IDENTIFICATION.—The Secretary, or State or local agency acting on behalf of the Secretary, may
p.000431: conduct in- spections only on presenting identification to the owner, operator, or agent in charge of the
p.000431: facility to be inspected.
p.000431: (C) SCOPE OF INSPECTION.—In conducting inspections, the Secretary or State or local agency acting on
p.000431: behalf of the Secretary—
p.000431: (i) shall have access to all equipment, materials, records, and information that the Secretary or State or local
p.000431: agency considers necessary to determine whether the facility is being operated in accordance with this section;
p.000431: and
p.000431: (ii) may copy, or require the facility to submit to the Secretary or the State or local agency, any
p.000431: of the materials, records, or information.
p.000431: (D) QUALIFICATIONS OF INSPECTORS.—Qualified indi- viduals, as determined by the Secretary, shall conduct
p.000431: all inspections. The Secretary may request that a State or local agency acting on behalf of the
p.000431: Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal
p.000431: officer or employee to con- duct inspections. The Secretary shall establish minimum qualifications and
p.000431: appropriate training for inspectors and criteria for certification of inspectors in order to inspect fa- cilities
p.000431: for compliance with subsection (f).
p.000431: (E) FREQUENCY.—The Secretary or State or local agen- cy acting on behalf of the Secretary shall conduct
p.000431: inspec-
p.000431: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000431: Sec. 354 PUBLIC HEALTH SERVICE ACT 432
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p.000431: January 30, 2020
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p.000431: tions under this paragraph of each facility not less often than annually, subject to paragraph (6).
p.000431: (F) RECORDS AND ANNUAL REPORTS.—The Secretary or a State or local agency acting on behalf of the Secretary
p.000431: which is responsible for inspecting mammography facilities shall maintain records of annual inspections
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p.000433: Sec. 354 PUBLIC HEALTH SERVICE ACT 434
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p.000433: January 30, 2020
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p.000433: (A) has been guilty of misrepresentation in obtaining the certificate;
p.000433: (B) has failed to comply with the requirements of sub- section (d)(1)(B)(ii)(III) or the standards established by the
p.000433: Secretary under subsection (f);
p.000433: (C) has failed to comply with reasonable requests of the Secretary (or of an accreditation body approved pursu-
p.000433: ant to subsection (e)) for any record, information, report, or material that the Secretary (or such accreditation
p.000433: body or State carrying out certification program requirements pur- suant to subsection (q)) concludes is
p.000433: necessary to deter- mine the continued eligibility of the facility for a certificate or continued compliance with
p.000433: the standards established under subsection (f);
p.000433: (D) has refused a reasonable request of the Secretary, any Federal officer or employee duly designated by the
p.000433: Secretary, or any State or local officer or employee duly designated by the State or local agency, for
p.000433: permission to inspect the facility or the operations and pertinent records of the facility in accordance with
p.000433: subsection (g);
p.000433: (E) has violated or aided and abetted in the violation of any provision of, or regulation promulgated
p.000433: under, this section; or
p.000433: (F) has failed to comply with a sanction imposed under subsection (h).
p.000433: (2) ACTION BEFORE A HEARING.—
p.000433: (A) IN GENERAL.—The Secretary may suspend the cer- tificate of the facility before holding a hearing required by
p.000433: paragraph (1) if the Secretary has reason to believe that the circumstance of the case will support one
p.000433: or more of the findings described in paragraph (1) and that—
p.000433: (i) the failure or violation was intentional; or
p.000433: (ii) the failure or violation presents a serious risk to human health.
p.000433: (B) HEARING.—If the Secretary suspends a certificate under subparagraph (A), the Secretary shall provide an op-
p.000433: portunity for a hearing to the owner or operator of the fa- cility not later than 60 days from the effective date of
p.000433: the suspension. The suspension shall remain in effect until the decision of the Secretary made after the hearing.
p.000433: (3) INELIGIBILITY TO OWN OR OPERATE FACILITIES AFTER REVOCATION.—If the Secretary revokes the certificate
p.000433: of a facil- ity on the basis of an act described in paragraph (1), no person who owned or operated the facility at the
p.000433: time of the act may, within 2 years of the revocation of the certificate, own or oper- ate a facility that requires a
p.000433: certificate under this section.
p.000433: (j) INJUNCTIONS.—If the Secretary determines that—
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p.000435: Sec. 354
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p.000435: January 30, 2020
p.000435: court of the United States for the district in which the facility is situated to enjoin the operation of the facility.
p.000435: Upon a proper showing, the district court shall grant a temporary injunction or restraining order against
p.000435: continuation of the activity or against operation of a facility, as the case may be, without re-
p.000435: quiring the Secretary to post a bond, pending issuance of a final order under this subsection.
p.000435: (k) JUDICIAL REVIEW.—
p.000435: (1) PETITION.—If the Secretary imposes a sanction on a fa- cility under subsection (h) or suspends or revokes
p.000435: the certifi- cate of a facility under subsection (i), the owner or operator of the facility may, not later than
p.000435: 60 days after the date the ac- tion of the Secretary becomes final, file a petition with the United
p.000435: States court of appeals for the circuit in which the facil- ity is situated for judicial review of the action. As soon
p.000435: as prac- ticable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the
p.000435: Secretary or other officer designated by the Secretary. As soon as practicable after re- ceipt of the copy,
p.000435: the Secretary shall file in the court the record on which the action of the Secretary is based, as provided
p.000435: in section 2112 of title 28, United States Code.
p.000435: (2) ADDITIONAL EVIDENCE.—If the petitioner applies to the court for leave to adduce additional evidence, and shows to
p.000435: the satisfaction of the court that the additional evidence is mate- rial and that there were reasonable
p.000435: grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may
p.000435: order the additional evidence (and evidence in rebuttal of the additional evidence) to be taken before the Sec-
p.000435: retary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the
p.000435: court may deter- mine to be proper. The Secretary may modify the findings of the Secretary as to the facts,
p.000435: or make new findings, by reason of the additional evidence so taken, and the Secretary shall file the modified or new
p.000435: findings, and the recommendations of the Secretary, if any, for the modification or setting aside of the
p.000435: original action of the Secretary with the return of the addi- tional evidence.
p.000435: (3) JUDGMENT OF COURT.—Upon the filing of the petition referred to in paragraph (1), the court shall
p.000435: have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or
p.000435: permanently. The findings of the Sec- retary as to the facts, if supported by substantial evidence, shall
p.000435: be conclusive.
p.000435: (4) FINALITY OF JUDGMENT.—The judgment of the court af- firming or setting aside, in whole or in part, any action of
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p.000441: reason- ably necessary.
p.000441: QUARANTINE STATIONS
p.000441: SEC. 364. ø267¿ (a) Except as provided in title II of the Act of June 15, 1917, as amended (U.S.C., 1940
p.000441: edition, title 50, secs. 191–194), 74 the Surgeon General shall control, direct, and manage all United States
p.000441: quarantine stations, grounds, and anchorages, designate their boundaries, and designate the quarantine
p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
p.000441: darkness. No vessel shall be required to undergo quar- antine inspection during the hours of darkness,
p.000441: unless the quar- antine officer at such quarantine station shall deem an immediate inspection necessary to protect
p.000441: the public health. Uniformity shall not be required in the hours during which quarantine inspection may
p.000441: be obtained at the various ports of the United States.
p.000441: (c) The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of
p.000441: employees of the United States Public Health Service, Foreign Quarantine Division, per- forming overtime
p.000441: duties including the operation of vessels, in con- nection with the inspection or quarantine treatment of
p.000441: persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or
p.000441: any place subject to the juris- diction thereof, hereinafter referred to as ‘‘employees of the Public Health
p.000441: Service’’, when required to be on duty between the hours of 6 o’clock postmeridian and 6 o’clock antemeridian
p.000441: (or between the hours of 7 o’clock postmeridian and 7 o’clock antemeridian at sta- tions which have a
p.000441: declared workday of from 7 o’clock antemeridian to 7 o’clock postmeridian), or on Sundays or holidays, such rate, in
p.000441: lieu of compensation under any other provision of law, to be fixed at two times the basic hourly rate for
p.000441: each hour that the overtime extends beyond 6 o’clock (or 7 o’clock as the case may be)
p.000441: postmeridian, and two times the basic hourly rate for each over- time hour worked on Sundays or
p.000441: holidays. As used in this sub- section, the term ‘‘basic hourly rate’’ shall mean the regular basic
...

p.000443: performed to file a bond in such amounts and containing such conditions and with such sure- ties, or in
p.000443: lieu of a bond, to deposit money or obligations of the United States in such amount, as will assure
p.000443: the payment of charges under this subsection, which bond or deposit may cover one or more transactions or all
p.000443: transactions during a specified period: Provided, That no charges shall be made for services performed in
p.000443: connection with the inspection of (1) persons arriving by inter- national highways, ferries, bridges, or
p.000443: tunnels, or the conveyances in which they arrive, or (2) persons arriving by aircraft or railroad trains, the
p.000443: operations of which are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons
p.000443: arriv- ing by vessels operated between Canadian ports and ports on Puget Sound or operated on the Great Lakes
p.000443: and connecting waterways, the operations of which are covered by published schedules, or the vessels in which they
p.000443: arrive.
p.000443: (2) Moneys collected under this subsection shall be deposited in
p.000443: the Treasury of the United States to the credit of the appropriation charged with the expense of the services, and the
p.000443: appropriations so credited shall be available for the payment of such compensation to the said employees for
p.000443: services so rendered.
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p.000443: January 30, 2020
p.000443: CERTAIN DUTIES OF CONSULAR AND OTHER OFFICERS
p.000443: SEC. 365. ø268¿ (a) Any consular or medical officer of the United States, designated for such purpose by the
p.000443: Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon
p.000443: General may prescribe, of the health con- ditions at the port or place at which such officer is stationed.
p.000443: (b) It shall be the duty of the customs officers and of Coast Guard officers to aid in the
p.000443: enforcement of quarantine rules and regulations; but no additional compensation, except actual and nec- essary
p.000443: traveling expenses, shall be allowed any such officer by rea- son of such services.
p.000443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000443: Sec. 366 PUBLIC HEALTH SERVICE ACT 444
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p.000443: January 30, 2020
p.000443:
p.000443: BILLS OF HEALTH
p.000443: SEC. 366. ø269¿ (a) Except as otherwise prescribed in regula- tions, any vessel at any foreign port or place
p.000443: clearing or departing for any port or place in a State or possession shall be required to obtain from
p.000443: the consular officer of the United States or from the Public Health Service officer, or other medical officer
p.000443: of the United States designated by the Surgeon General, at the port or place of departure, a bill of
p.000443: health in duplicate, in the form prescribed by the Surgeon General. The President, from time to time, shall
p.000443: speci- fy the ports at which a medical officer shall be stationed for this purpose. Such bill of health
p.000443: shall set forth the sanitary history and condition of said vessel, and shall state that it has in all
p.000443: respects complied with the regulations prescribed pursuant to subsection (c). Before granting such duplicate bill of
p.000443: health, such consular or med- ical officer shall be satisfied that the matters and things therein stated are
p.000443: true. The consular officer shall be entitled to demand and receive the fees for bills of health and such fees
p.000443: shall be estab- lished by regulation.
p.000443: (b) Original bills of health shall be delivered to the collectors
p.000443: of customs at the port of entry. Duplicate copies of such bills of health shall be delivered at the time of
p.000443: inspection to quarantine of- ficers at such port. The bills of health herein prescribed shall be considered
p.000443: as part of the ship’s papers, and when duly certified to by the proper consular or other officer of the United
p.000443: States, over his official signature and seal, shall be accepted as evidence of the statements therein contained in
p.000443: any court of the United States.
p.000443: (c) The Surgeon General shall from time to time prescribe reg- ulations, applicable to vessels referred to in
p.000443: subsection (a) of this section for the purpose of preventing the introduction into the States or
p.000443: possessions of the United States of any communicable dis- ease by securing the best sanitary condition of such
p.000443: vessels, their cargoes, passengers, and crews. Such regulations shall be observed by such vessels prior to departure,
p.000443: during the course of the voyage, and also during inspection, disinfection, or other quarantine proce- dure upon arrival
p.000443: at any United States quarantine station.
p.000443: (d) The provisions of subsections (a) and (b) of this section shall not apply to vessels plying between such
p.000443: foreign ports on or near the frontiers of the United States and ports of the United States as are
p.000443: designated by treaty.
p.000443: (e) It shall be unlawful for any vessel to enter any port in any State or possession of the United States to
p.000443: discharge its cargo, or land its passengers, except upon a certificate of the quarantine offi- cer that regulations
p.000443: prescribed under subsection (c) have in all re- spects been complied with by such officer, the vessel, and its mas-
p.000443: ter. The master of every such vessel shall deliver such certificate to the collector of customs at the
p.000443: port of entry, together with the original bill of health and other papers of the vessel. The certificate required
p.000443: by this subsection shall be procurable from the quarantine officer, upon arrival of the vessel at the quarantine
p.000443: station and sat- isfactory inspection thereof, at any time within which quarantine services are performed at
p.000443: such station.
p.000443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000445: PUBLIC HEALTH SERVICE ACT
p.000445: Sec. 371
p.000445:
p.000445: CIVIL AIR NAVIGATION AND CIVIL AIRCRAFT
p.000445: SEC. 367. ø270¿ The Surgeon General is authorized to provide by regulations for the application to air
p.000445: navigation and aircraft of any of the provisions of sections 364, 365, and 366 and regulations prescribed thereunder
p.000445: (including penalties and forfeitures for viola- tions of such sections and regulations), to such extent and
p.000445: upon such conditions as he deems necessary for the safeguarding of the public health.
p.000445: PENALTIES
p.000445: SEC. 368. ø271¿ (a) Any person who violates any regulation prescribed under section 361, 362, or 363,
p.000445: or any provision of sec- tion 366 or any regulation prescribed thereunder, or who enters or departs from the
p.000445: limits of any quarantine station, ground, or an- chorage in disregard of quarantine rules and regulations or
p.000445: without permission of the quarantine officer in charge, shall be punished by a fine of not more than $1,000 or
p.000445: by imprisonment for not more than one year, or both.
p.000445: (b) Any vessel which violates section 366, or any regulations thereunder or under section 364, or which enters
p.000445: within or departs from the limits of any quarantine station, ground, or anchorage in disregard of the quarantine
p.000445: rules and regulations or without per- mission of the officer in charge, shall forfeit to the United
p.000445: States not more than $5,000, the amount to be determined by the court, which shall be a lien on such vessel,
p.000445: to be recovered by proceedings in the proper district court of the United States. In all such pro- ceedings
p.000445: the United States attorney shall appear on behalf of the United States; and all such proceedings shall
p.000445: be conducted in ac- cordance with the rules and laws governing cases of seizure of ves- sels for violation of the
p.000445: revenue laws of the United States.
p.000445: (c) With the approval of the Secretary, the Surgeon General may, upon application therefor, remit or
p.000445: mitigate any forfeiture provided for under subsection (b) of this section, and he shall have authority to ascertain
p.000445: the facts upon all such applications.
p.000445: ADMINISTRATION OF OATHS
p.000445: SEC. 369. ø272¿ Medical officers of the United States, when performing duties as quarantine officers at any
p.000445: port or place within the United States, are authorized to take declarations and admin- ister oaths in matters
p.000445: pertaining to the administration of the quar- antine laws and regulations of the United States.
p.000445: PART H—ORGAN TRANSPLANTS 75
p.000445: ORGAN PROCUREMENT ORGANIZATIONS
p.000445: SEC. 371. ø273¿ (a)(1) The Secretary may make grants for the planning of qualified organ procurement organizations
p.000445: described in subsection (b).
p.000445:
p.000445: 75 Section 301 of the National Organ Transplant Act (Public Law 98–507; 42 U.S.C. 274e) pro- vides:
p.000445:
p.000445:
p.000445: January 30, 2020
p.000445: Continued
p.000445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000445:
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p.000515: para- graph (1), and the Director shall carry out such activities under paragraph (2), as may be
p.000515: necessary to ensure that the Foundation maintains status as an organization that—
p.000515: (A) is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and
p.000515: (B) is, under subsection (a) of such section, exempt from taxation.
p.000515: (f) BOARD OF DIRECTORS.—
p.000515: (1) CERTAIN BYLAWS.—
p.000515: (A) In establishing bylaws under subsection (e)(1), the Board shall ensure that the bylaws of the Foundation
p.000515: in- clude bylaws for the following:
p.000515: (i) Policies for the selection of the officers, employ- ees, agents, and contractors of the Foundation.
p.000515: (ii) Policies, including ethical standards, for the acceptance and disposition of donations to the Founda- tion
p.000515: and for the disposition of the assets of the Foun- dation.
p.000515: (iii) Policies for the conduct of the general oper- ations of the Foundation.
p.000515: (iv) Policies for writing, editing, printing, and pub- lishing of books and other materials, and the acquisi-
p.000515: tion of patents and licenses for devices and procedures developed by the Foundation.
p.000515: (B) In establishing bylaws under subsection (e)(1), the Board shall ensure that the bylaws of the Foundation (and
p.000515: activities carried out under the bylaws) do not—
p.000515: (i) reflect unfavorably upon the ability of the Foundation, or the Centers for Disease Control and
p.000515: Prevention, to carry out its responsibilities or official duties in a fair and objective manner; or
p.000515: (ii) compromise, or appear to compromise, the in- tegrity of any governmental program or any officer or
p.000515: employee involved in such program.
p.000515: (2) COMPOSITION.—
p.000515: (A) Subject to subparagraph (B), the Board shall be composed of 7 individuals, appointed in accordance
p.000515: with paragraph (4), who collectively possess education or experi- ence appropriate for representing the general field
p.000515: of pub- lic health, the general field of international health, and the general public. Each such individual shall
p.000515: be a voting member of the Board.
p.000515: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000515:
p.000515:
p.000515:
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p.000515:
p.000515: Sec. 399G PUBLIC HEALTH SERVICE ACT 516
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p.000515: January 30, 2020
p.000515:
p.000515: (B) The Board may, through amendments to the by- laws of the Foundation, provide that the number of
p.000515: mem- bers of the Board shall be a greater number than the num- ber specified in subparagraph (A).
...

p.000517: be accepted and utilized by such Di- rector under the preceding sentence without regard to whether the funds are
p.000517: designated as general-purpose funds or special- purpose funds.
p.000517: (2) AUTHORITY FOR ACCEPTANCE OF VOLUNTARY SERV- ICES.—
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p.000517: January 30, 2020
p.000517: (A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal
p.000517: Gov- ernment, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or
p.000517: facilitating the work of such Centers. In the case of an individual, such Director may accept the
p.000517: services provided under the preceding sentence by the individual until such time as the private funding for such
p.000517: individual ends.
p.000517: (B) The limitation established in subparagraph (A) re- garding the period of time in which services may be
p.000517: ac- cepted applies to each individual who is not an employee of the Federal Government and who serves
p.000517: in association with the Centers for Disease Control and Prevention pur- suant to financial support from the
p.000517: Foundation.
p.000517: (3) ADMINISTRATIVE CONTROL.—No officer, employee, or member of the Board of the Foundation may
p.000517: exercise any ad- ministrative or managerial control over any Federal employee.
p.000517: (4) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL EMPLOYEES.—In the case of any individual who is not
p.000517: an em- ployee of the Federal Government and who serves in associa- tion with the Centers for Disease Control
p.000517: and Prevention pur- suant to financial support from the Foundation, the Founda- tion shall negotiate a
p.000517: memorandum of understanding with the individual and the Director of the Centers for Disease Control and Prevention
p.000517: specifying that the individual—
p.000517: (A) shall be subject to the ethical and procedural standards regulating Federal employment, scientific
p.000517: inves- tigation, and research findings (including publications and patents) that are required of individuals
p.000517: employed by the Centers for Disease Control and Prevention, including standards under this Act, the
p.000517: Ethics in Government Act, and the Technology Transfer Act; and
p.000517: (B) shall be subject to such ethical and procedural standards under chapter 11 of title 18, United States Code
p.000517: (relating to conflicts of interest), as the Director of such Centers determines is appropriate, except
p.000517: such memo- randum may not provide that the individual shall be sub- ject to the standards of section 209 of such
p.000517: chapter.
p.000517: (5) FINANCIAL CONFLICTS OF INTEREST.—Any individual who is an officer, employee, or member of the
p.000517: Board of the Foundation may not directly or indirectly participate in the
p.000517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000517:
p.000517:
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p.000517:
p.000517: Sec. 399G PUBLIC HEALTH SERVICE ACT 518
p.000517:
p.000517: consideration or determination by the Foundation of any ques- tion affecting—
p.000517: (A) any direct or indirect financial interest of the indi- vidual; or
p.000517: (B) any direct or indirect financial interest of any busi- ness organization or other entity of which the individual is
p.000517: an officer or employee or in which the individual has a di- rect or indirect financial interest.
p.000517: (6) AUDITS; AVAILABILITY OF RECORDS.—The Foundation shall—
p.000517: (A) provide for biennial audits of the financial condi- tion of the Foundation; and
p.000517: (B) make such audits, and all other records, docu- ments, and other papers of the Foundation, available
p.000517: to the Secretary and the Comptroller General of the United States for examination or audit.
p.000517: (7) REPORTS.—
p.000517: (A) Not later than February 1 of each fiscal year, the Foundation shall publish a report describing the
p.000517: activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal
p.000517: year involved a com- prehensive statement of the operations, activities, financial condition, and accomplishments of
p.000517: the Foundation, includ- ing an accounting of the use of amounts provided for under subsection (i).
p.000517: (B) With respect to the financial condition of the Foun- dation, each report under subparagraph (A) shall
p.000517: include the source, and a description of, all gifts to the Foundation of real or personal property, and the source and
p.000517: amount of all gifts to the Foundation of money. Each such report shall include a specification of any
p.000517: restrictions on the pur- poses for which gifts to the Foundation may be used.
p.000517: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000517: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000517: charge not to exceed the cost of providing the copy; and
p.000517:
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...

p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
p.000571: (B) MENTAL HEALTH.—Mental health and substance use disorder assessments, crisis intervention, counseling,
p.000571: treatment, and referral to a continuum of services includ- ing emergency psychiatric care, community
p.000571: support pro- grams, inpatient care, and outpatient programs.
p.000571: (2) MEDICALLY UNDERSERVED CHILDREN AND ADOLES- CENTS.—
p.000571: (A) IN GENERAL.—The term ‘‘medically underserved children and adolescents’’ means a population of children
p.000571: and adolescents who are residents of an area designated as a medically underserved area or a health
p.000571: professional shortage area by the Secretary.
p.000571: (B) CRITERIA.—The Secretary shall prescribe criteria for determining the specific shortages of personal
p.000571: health services for medically underserved children and adoles- cents under subparagraph (A) that shall—
p.000571: (i) take into account any comments received by the Secretary from the chief executive officer of a State
p.000571: and local officials in a State; and
p.000571: (ii) include factors indicative of the health status of such children and adolescents of an area, including the
p.000571: ability of the residents of such area to pay for health services, the accessibility of such services,
p.000571: the availability of health professionals to such children
p.000571: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000571:
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p.000573: 573
p.000573: PUBLIC HEALTH SERVICE ACT
p.000573: Sec. 399Z–1
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p.000573: January 30, 2020
p.000573: and adolescents, and other factors as determined ap- propriate by the Secretary.
p.000573: (3) SCHOOL-BASED HEALTH CENTER.—The term ‘‘school- based health center’’ means a health clinic that—
...

p.000755: January 30, 2020
p.000755: 45 Probably should be section 231. That section formerly was section 2701, and was redesig- nated by
p.000755: subsection (a)(2) of section 2010 of Public Law 103–43 (107 Stat. 213). Subsection (b)(5) of such section purported
p.000755: to conform the above reference, but the amendment cannot be exe- cuted because the amendment applied to the
p.000755: incorrect section. (The conforming amendment ap- plied to section 485. Section 464X formerly was section 485,
p.000755: and was redesignated by section 1511(b)(2)(B) of Public Law 103–43 (107 Stat. 179).)
p.000755: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000755: Sec. 464X PUBLIC HEALTH SERVICE ACT 756
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p.000755: January 30, 2020
p.000755:
p.000755: (A) the Secretary, the Director of NIH, the Director of the Institute, the chief nursing officer of the
p.000755: Department of Vet- erans Affairs, the Assistant Secretary of Defense for Health Af- fairs, the Director of the
p.000755: Division of Nursing of the Health Re- sources and Services Administration (or the designees of such officers),
p.000755: and
p.000755: (B) such additional officers or employees of the United States as the Secretary determines necessary for
p.000755: the advisory council to effectively carry out its functions.
p.000755: (3) The members of the advisory council who are not ex officio members shall be appointed as follows:
p.000755: (A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of
p.000755: the health and scientific disciplines (including public health and the be- havioral or social sciences)
p.000755: relevant to the activities of the In- stitute. Of the members appointed pursuant to this subpara- graph,
p.000755: at least seven shall be professional nurses who are rec- ognized experts in the area of clinical practice, education,
p.000755: or re- search.
p.000755: (B) One-third of the members shall be appointed by the Secretary from the general public and shall
p.000755: include leaders in fields of public policy, law, health policy, economics, and man- agement.
p.000755: (4) Members of the advisory council who are officers or employ- ees of the United States shall not receive any
p.000755: compensation for service on the advisory council. The other members of the advisory council shall receive, for
p.000755: each day (including traveltime) they are engaged in the performance of the functions of the advisory council,
...

p.000809: 809
p.000809: PUBLIC HEALTH SERVICE ACT
p.000809: Sec. 495
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p.000809: January 30, 2020
p.000809: (2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall
p.000809: require—
p.000809: (A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such
p.000809: research; and
p.000809: (B) appropriate pre-surgical and post-surgical veteri- nary medical and nursing care for animals in such
p.000809: re- search.
p.000809: Such guidelines shall not be construed to prescribe methods of research.
p.000809: (3) The organization and operation of animal care commit- tees in accordance with subsection (b).
p.000809: (b)(1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which
p.000809: conducts bio- medical and behavioral research with funds provided under this Act (including the National
p.000809: Institutes of Health and the national research institutes) to assure compliance with the guidelines estab- lished
p.000809: under subsection (a).
p.000809: (2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the
p.000809: committee is estab- lished, shall be composed of not fewer than three members, and shall include at
p.000809: least one individual who has no association with such entity and at least one doctor of veterinary medicine.
p.000809: (3) Each animal care committee of a research entity shall—
p.000809: (A) review the care and treatment of animals in all animal study areas and facilities of the research entity at
p.000809: least semi- annually to evaluate compliance with applicable guidelines es- tablished under subsection (a) for
p.000809: appropriate animal care and treatment;
p.000809: (B) keep appropriate records of reviews conducted under subparagraph (A); and
p.000809: (C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a
p.000809: certification that the review has been conducted, and (ii) reports of any vio- lations of guidelines established under
p.000809: subsection (a) or assur- ances required under paragraph (1) which were observed in such review and which have
p.000809: continued after notice by the com- mittee to the research entity involved of the violations.
p.000809: Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.
p.000809: (c) The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement
p.000809: involving research on ani- mals which is administered by the National Institutes of Health or any national research
p.000809: institute to include in its application or con- tract proposal, submitted after the expiration of the
p.000809: twelve-month period beginning on the date of enactment of this section—
p.000809: (1) assurances satisfactory to the Director of NIH that—
...

p.000819: respect to ethical standards shall ensure that officers, employ- ees and agents of the Foundation (including
p.000819: members of the Board) avoid encumbrances that would result in a conflict of interest, including a financial
p.000819: conflict of interest or a divided allegiance. Such policies shall in- clude requirements for the provision of
p.000819: information concerning any ownership or controlling interest in en- tities related to the activities of the
p.000819: Foundation by such officers, employees and agents and their spouses and relatives.
p.000819: (iii) Policies for the conduct of the general oper- ations of the Foundation.
p.000819: (iv) Policies for writing, editing, printing, pub- lishing, and vending of books and other materials.
p.000819: (B) In establishing bylaws under this subsection, the Board shall ensure that such bylaws (and activities
p.000819: carried out under the bylaws) do not—
p.000819: (i) reflect unfavorably upon the ability of the Foundation or the National Institutes of Health to
p.000819: carry out its responsibilities or official duties in a fair and objective manner; or
p.000819: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000819:
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p.000821: 821
p.000821: PUBLIC HEALTH SERVICE ACT
p.000821: Sec. 499
p.000821:
p.000821: (ii) compromise, or appear to compromise, the in- tegrity of any governmental agency or program, or any officer
p.000821: or employee involved in such program.
p.000821: (e) INCORPORATION.—The initial members of the Board shall serve as incorporators and shall take whatever actions
p.000821: necessary to incorporate the Foundation.
p.000821: (f) NONPROFIT STATUS.—The Foundation shall be considered to be a corporation under section 501(c) of the Internal
p.000821: Revenue Code of 1986, and shall be subject to the provisions of such section.
p.000821: (g) EXECUTIVE DIRECTOR.—
p.000821: (1) IN GENERAL.—The Foundation shall have an Executive Director who shall be appointed by the Board and shall
p.000821: serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day
p.000821: operations of the Foundation and shall have such specific duties and responsibilities as the Board shall
p.000821: prescribe.
p.000821: (2) COMPENSATION.—The rate of compensation of the Exec- utive Director shall be fixed by the Board.
p.000821: (h) POWERS.—In carrying out subsection (b), the Foundation may—
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p.000821: (1) operate under the direction of its Board;
p.000821: (2) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.000821: (3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties,
p.000821: and require surety bonds or make other provisions against losses occasioned by acts of such persons;
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p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
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p.000821: Sec. 499 PUBLIC HEALTH SERVICE ACT 822
p.000821:
p.000821: (13) appoint other groups of advisors as may be deter- mined necessary from time to time to carry out
p.000821: the functions of the Foundation;
p.000821: (14) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion; and
p.000821: (15) exercise other powers as set forth in this section, and such other incidental powers as are necessary to
p.000821: carry out its powers, duties, and functions in accordance with this part.
p.000821: (i) ADMINISTRATIVE CONTROL.—No participant in the program established under this part shall exercise any
p.000821: administrative con- trol over any Federal employee.
p.000821: (j) GENERAL PROVISIONS.—
p.000821: (1) FOUNDATION INTEGRITY.—The members of the Board shall be accountable for the integrity of the
p.000821: operations of the Foundation and shall ensure such integrity through the devel- opment and enforcement of criteria
p.000821: and procedures relating to standards of conduct, financial disclosure statements, conflict of interest rules,
p.000821: recusal and waiver rules, audits and other matter determined appropriate by the Board.
p.000821: (2) FINANCIAL CONFLICTS OF INTEREST.—Any individual who is an officer, employee, or member of the
p.000821: Board of the Foundation may not (in accordance with policies and require- ments developed under subsection
p.000821: (d)(6)) 56 personally or sub- stantially participate in the consideration or determination by the
p.000821: Foundation of any matter that would directly or predict- ably affect any financial interest of the individual
p.000821: or a relative (as such term is defined in section 109(16) of the Ethics in Gov- ernment Act of 1978) of the individual,
p.000821: of any business organi- zation or other entity, or of which the individual is an officer or employee, or is
p.000821: negotiating for employment, or in which the individual has any other financial interest.
p.000821: (3) AUDITS; AVAILABILITY OF RECORDS.—The Foundation shall—
p.000821: (A) provide for annual audits of the financial condition of the Foundation; and
p.000821: (B) make such audits, and all other records, docu- ments, and other papers of the Foundation, available
p.000821: to the Secretary and the Comptroller General of the United States for examination or audit.
p.000821: (4) REPORTS.—
p.000821: (A) Not later than 5 months following the end of each fiscal year, the Foundation shall publish a report
p.000821: describ- ing the activities of the Foundation during the preceding fiscal year. Each such report shall
p.000821: include for the fiscal year involved a comprehensive statement of the oper- ations, activities,
p.000821: financial condition, and accomplishments of the Foundation, including an accounting of the use of amounts
p.000821: transferred under subsection (l).
p.000821:
p.000821:
p.000821:
p.000821:
p.000821:
p.000821: January 30, 2020
p.000821: 56 Section 13(7) of Public Law 107–109 (115 Stat. 1419) provided that paragraphs (1) and (2) of section 499(j)
p.000821: are amended ‘‘by striking ‘(including those developed under subsection (d)(2)(B)(i)(II))’ each place it
p.000821: appears’’. The term to be struck appeared in paragraph (1), but not in paragraph (2).
p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
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...

p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000831:
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p.000831:
p.000831: Sec. 501 PUBLIC HEALTH SERVICE ACT 832
p.000831:
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p.000831:
p.000831: January 30, 2020
p.000831:
p.000831: (B) assist the Assistant Secretary in the evaluation, organization, integration, and coordination of programs
p.000831: op- erated by the Administration;
p.000831: (C) promote evidence-based and promising best prac- tices, including culturally and linguistically
p.000831: appropriate practices, as appropriate, for the prevention and treatment of, and recovery from, mental and substance use
...

p.000837: ELS.—
p.000837:
p.000837:
p.000837:
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p.000837:
p.000837: January 30, 2020
p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
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p.000837:
p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837:
p.000837: January 30, 2020
p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000837:
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p.000839: 839
p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
p.000839: (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.
p.000839: ADVISORY COUNCILS
p.000839: SEC. 502. ø290aa–1¿ (a) APPOINTMENT.—
p.000839: (1) IN GENERAL.—The Secretary shall appoint an advisory council for—
p.000839: (A) the Substance Abuse and Mental Health Services Administration;
p.000839: (B) the Center for Substance Abuse Treatment;
p.000839: (C) the Center for Substance Abuse Prevention; and
...

p.000839: (b) MEMBERSHIP.—
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000839:
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p.000839: Sec. 502 PUBLIC HEALTH SERVICE ACT 840
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p.000839: January 30, 2020
p.000839:
p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
p.000839: members to be appointed by the Secretary under paragraph (3).
p.000839: (2) EX OFFICIO MEMBERS.—The ex officio members of an advisory council shall consist of—
p.000839: (A) the Secretary;
p.000839: (B) the Assistant Secretary;
p.000839: (C) the Director of the Center for which the council is established;
p.000839: (D) the Under Secretary for Health of the Department of Veterans Affairs;
p.000839: (E) the Assistant Secretary for Defense for Health Af- fairs (or the designates of such officers);
p.000839: (F) the Chief Medical Officer, appointed under section 501(g);
p.000839: (G) the Director of the National Institute of Mental Health for the advisory councils appointed
p.000839: under sub- sections (a)(1)(A) and (a)(1)(D);
p.000839: (H) the Director of the National Institute on Drug Abuse for the advisory councils appointed under
p.000839: sub- sections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.000839: (I) the Director of the National Institute on Alcohol Abuse and Alcoholism for the advisory councils
p.000839: appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and
p.000839: (J) such additional officers or employees of the United States as the Secretary determines necessary for the advi- sory
p.000839: council to effectively carry out its functions.
p.000839: (3) APPOINTED MEMBERS.—Individuals shall be appointed to an advisory council under paragraph (1) as follows:
p.000839: (A) Nine of the members shall be appointed by the Secretary from among the leading representatives of
p.000839: the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
p.000839: the Admin- istration or Center for which the advisory council is estab- lished.
p.000839: (B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders
p.000839: in fields of public policy, public relations, law, health policy economics, or management.
p.000839: (C) Not less than half of the members of the advisory council appointed under subsection (a)(1)(D)—
p.000839: (i) shall—
...

p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: Continued
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
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p.000843: Sec. 505 PUBLIC HEALTH SERVICE ACT 844
p.000843:
p.000843: and Quality (in this section referred to as the ‘‘Center’’). The Cen- ter shall be headed by a Director (in
p.000843: this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive
p.000843: experience and academic qualifications in research and analysis in behavioral health care or related fields. (b)
p.000843: The Director shall—
p.000843: (1) coordinate the Administration’s integrated data strategy, including by collecting data each year on——
p.000843: (A) the national incidence and prevalence of the var- ious forms of mental illness and substance abuse; and
p.000843: (B) the incidence and prevalence of such various forms in major metropolitan areas selected by the Director. 3
p.000843: (2) provide statistical and analytical support for activities of the Administration;
p.000843: (3) recommend a core set of performance metrics to evalu- ate activities supported by the Administration; and
p.000843: (4) coordinate with the Assistant Secretary, the Assistant Secretary for Planning and Evaluation, and the
p.000843: Chief Medical Officer appointed under section 501(g), as appropriate, to im- prove the quality of services
p.000843: provided by programs of the Ad- ministration and the evaluation of activities carried out by the Administration.
p.000843: (c) MENTAL HEALTH.—With respect to the activities of the Di- rector under subsection (b)(1) relating to mental
p.000843: health, the Direc- tor shall ensure that such activities include, at a minimum, the col- lection of data on—
p.000843: (1) the number and variety of public and nonprofit private treatment programs;
p.000843: (2) the number and demographic characteristics of individ- uals receiving treatment through such programs;
p.000843: (3) the type of care received by such individuals; and
p.000843: (4) such other data as may be appropriate.
p.000843: (d) SUBSTANCE ABUSE.—
p.000843: (1) IN GENERAL.—With respect to the activities of the Di- rector under subsection (b)(1) relating to
p.000843: substance abuse, the Director shall ensure that such activities include, at a min- imum, the collection of
p.000843: data on—
p.000843: (A) the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of
p.000843: alcohol or other drugs;
p.000843: (B) the number of deaths occurring as a result of substance abuse, as indicated in reports by coroners in coordination
p.000843: with the Centers for Disease Control and Prevention;
...

p.000873: (b) DUTIES.—The Director of the Center shall—
p.000873: (1) design national goals and establish national priorities for—
p.000873: (A) the prevention of mental illness; and
p.000873: (B) the promotion of mental health;
p.000873: (2) encourage and assist local entities and State agencies to achieve the goals and priorities described
p.000873: in paragraph (1);
p.000873:
p.000873:
p.000873:
p.000873:
p.000873: January 30, 2020
p.000873: 9 So in law. Probably should read ‘‘; and’’. See section 3110 of Public Law 106–310 (114 Stat. 1185).
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000875: 875
p.000875: PUBLIC HEALTH SERVICE ACT
p.000875: Sec. 520
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p.000875: January 30, 2020
p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
...

p.000905: the Secretary a report in such form and containing such information as the Secretary determines (after
p.000905: consultation with the Assistant Secretary for Mental Health and Substance Use) to be necessary for—
p.000905: (1) securing a record and a description of the purposes for which amounts received under section 521 were expended dur-
p.000905: ing the preceding fiscal year and of the recipients of such amounts; and
p.000905: (2) determining whether such amounts were expended in accordance with the provisions of this part.
p.000905: (b) AVAILABILITY TO PUBLIC OF REPORTS.—The Secretary may not make payments under section 521 unless the
p.000905: State involved agrees to make copies of the reports described in subsection (a) available for public
p.000905: inspection.
p.000905: (c) EVALUATIONS BY COMPTROLLER GENERAL.—The Assistant Secretary for Mental Health and Substance Use
p.000905: shall evaluate at least once every 3 years the expenditures of grants under this part by eligible entities in
p.000905: order to ensure that expenditures are con- sistent with the provisions of this part, and shall include
p.000905: in such evaluation recommendations regarding changes needed in program design or operations.
p.000905: SEC. 529. ø290cc–29¿ REQUIREMENT OF APPLICATION.
p.000905: The Secretary may not make payments under section 521 un- less the State involved—
p.000905: (1) submits to the Secretary an application for the pay- ments containing agreements and information in
p.000905: accordance with this part;
p.000905: (2) the agreements are made through certification from the chief executive officer of the State; and
p.000905: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.000905: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.000905: SEC. 530. ø290cc–30¿ TECHNICAL ASSISTANCE.
p.000905: The Secretary, acting through the Assistant Secretary, shall provide technical assistance to eligible
p.000905: entities in developing plan- ning and operating programs in accordance with the provisions of this part.
p.000905: SEC. 531. ø290cc–31¿ FAILURE TO COMPLY WITH AGREEMENTS.
p.000905: (a) REPAYMENT OF PAYMENTS.—
p.000905: (1) The Secretary may, subject to subsection (c), require a State to repay any payments received by the
p.000905: State under sec- tion 521 that the Secretary determines were not expended by the State in accordance
p.000905: with the agreements required to be contained in the application submitted by the State pursuant to section
p.000905: 529.
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000905:
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p.000905: Sec. 532 PUBLIC HEALTH SERVICE ACT 906
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p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.000907: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.000907: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.000907: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.000907: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section
p.000907: 521 shall be considered to be programs and activities receiving Federal fi- nancial assistance.
p.000907: (2) PROHIBITION.—No person shall on the ground of sex or religion be excluded from participation in, be denied the
p.000907: bene- fits of, or be subjected to discrimination under, any program or activity funded in whole or in part with
p.000907: funds made available under section 521.
p.000907: (b) ENFORCEMENT.—
p.000907: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.000907: entity that has received a payment pursuant to section 521, has failed to comply with a provision of law
p.000907: referred to in subsection (a)(1), with subsection (a)(2), or with an applicable regulation (includ- ing one prescribed
p.000907: to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the State and shall re-
p.000907: quest the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days,
p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
p.000907: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.000907: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.000907: Rights Act of 1964, as may be applicable; or
p.000907: (C) take such other actions as may be authorized by
p.000907:
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p.000907:
p.000907:
p.000907: January 30, 2020
p.000907: law.
p.000907: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
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p.000961: except with re- gard to any project for which the application has already been approved and which is not directly
p.000961: affected, further payments may be withheld, in whole or in part, until there is no longer any failure to
p.000961: comply (or carry out the assurance or plans and specifications or provide adequate State funds, as the case may be)
p.000961: or, if such compliance (or other action) is impossible, until the State repays or arranges for the
p.000961: repayment of Federal moneys to which the recipient was not entitled.
p.000961:
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p.000961: January 30, 2020
p.000961: JUDICIAL REVIEW
p.000961: SEC. 608. ø291h¿ (a) If the Surgeon General refuses to approve any application for a project submitted under section
p.000961: 605 or section 610, the State agency through which such application was sub- mitted, or if any State is
p.000961: dissatisfied with his action under section 607 such State may appeal to the United States court of appeals
p.000961: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000961:
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p.000961: Sec. 609 PUBLIC HEALTH SERVICE ACT 962
p.000961:
p.000961: for the circuit in which such State is located, by filing a petition with such court within sixty days
p.000961: after such action. A copy of the petition shall be forthwith transmitted by the clerk of the court to the
p.000961: Surgeon General, or any officer designated by him for that pur- pose. The Surgeon General shall thereupon file
p.000961: in the court the record of the proceedings on which he based his action, as provided in section 2112 of title
p.000961: 28, United States Code. Upon the filing of such petition, the court shall have jurisdiction to affirm the action
p.000961: of the Surgeon General or to set it aside, in whole or in part, tem- porarily or permanently, but until the filing of
p.000961: the record, the Sur- geon General may modify or set aside his order.
p.000961: (b) The findings of the Surgeon General as to the facts, if sup- ported by substantial evidence, shall be
p.000961: conclusive, but the court, for good cause shown, may remand the case to the Surgeon General to take further
p.000961: evidence, and the Surgeon General may thereupon make new or modified findings of fact and may modify his previous
p.000961: action, and shall file in the court the record of the further pro- ceedings. Such new or modified
p.000961: findings of fact shall likewise be conclusive if supported by substantial evidence.
p.000961: (c) The judgment of the court affirming or setting aside, in whole or in part, any action of the Surgeon
p.000961: General shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification
p.000961: as provided in section 1254 of title 28, United States Code. The commencement of proceedings under this section
p.000961: shall not, unless so specifically ordered by the court, oper- ate as a stay of the Surgeon General’s action.
p.000961: RECOVERY
p.000961: SEC. 609. 1 ø291i¿ (a) If any facility with respect to which funds have been paid under section 606
p.000961: shall, at any time within 20 years after the completion of construction or modernization—
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p.001057: osteopathic medicine and public and private teaching hospitals; and
p.001057: (6) 4 members appointed by the Secretary to include rep- resentatives of health insurers, business, and labor.
p.001057: (c) TERMS OF APPOINTED MEMBERS.—
p.001057: (1) IN GENERAL; STAGGERED ROTATION.—Members of the Council appointed under paragraphs (4), (5), and (6)
p.001057: of sub- section (b) shall be appointed for a term of 4 years, except that the term of office of the members
p.001057: first appointed shall expire, as designated by the Secretary at the time of appointment, 4 at the end
p.001057: of 1 year, 4 at the end of 2 years, 3 at the end of 3 years, and 3 at the end of 4 years.
p.001057: (2) DATE CERTAIN FOR APPOINTMENT.—The Secretary shall appoint the first members to the Council under paragraphs (4),
p.001057: (5), and (6) of subsection (b) within 60 days after the date of enactment of this section.
p.001057: (d) CHAIR.—The Council shall elect one of its members as Chairman of the Council.
p.001057: (e) QUORUM.—Nine members of the Council shall constitute a quorum, but a lesser number may hold hearings.
p.001057: (f) VACANCIES.—Any vacancy in the Council shall not affect its power to function.
p.001057: (g) COMPENSATION.—Each member of the Council who is not otherwise employed by the United States Government
p.001057: shall receive compensation at a rate equal to the daily rate prescribed for GS–
p.001057: 18 under the General Schedule under section 5332 of title 5, United States Code, for each day, including
p.001057: traveltime, such mem- ber is engaged in the actual performance of duties as a member of the Council. A member of the
p.001057: Council who is an officer or employee of the United States Government shall serve without additional
p.001057: compensation. All members of the Council shall be reimbursed for travel, subsistence, and other necessary
p.001057: expenses incurred by them in the performance of their duties.
p.001057: (h) CERTAIN AUTHORITIES AND DUTIES.—
p.001057: (1) AUTHORITIES.—In order to carry out the provisions of this section, the Council is authorized to—
p.001057: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001059: 1059
p.001059: PUBLIC HEALTH SERVICE ACT
p.001059: Sec. 763
p.001059:
p.001059: (A) collect such information, hold such hearings, and sit and act at such times and places, either as
p.001059: a whole or by subcommittee, and request the attendance and testi- mony of such witnesses and the
p.001059: production of such books, records, correspondence, memoranda, papers, and docu- ments as the Council or
p.001059: such subcommittee may consider available; and
p.001059: (B) request the cooperation and assistance of Federal departments, agencies, and instrumentalities, and such de-
p.001059: partments, agencies, and instrumentalities are authorized to provide such cooperation and assistance.
p.001059: (2) COORDINATION OF ACTIVITIES.—The Council shall co- ordinate its activities with the activities of the
p.001059: Secretary under section 792 of the Public Health Service Act. The Secretary shall, in cooperation with the
...

p.001155: SEC. 945. ø299c–4¿ ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.
p.001155: (a) FINANCIAL CONFLICTS OF INTEREST.—With respect to projects for which awards of grants,
p.001155: cooperative agreements, or contracts are authorized to be made under this title, the Director shall by
p.001155: regulation define—
p.001155: (1) the specific circumstances that constitute financial in- terests in such projects that will, or may
p.001155: be reasonably ex- pected to, create a bias in favor of obtaining results in the projects that are
p.001155: consistent with such interests; and
p.001155: (2) the actions that will be taken by the Director in re- sponse to any such interests identified by the
p.001155: Director.
p.001155: (b) REQUIREMENT OF APPLICATION.—The Director may not, with respect to any program under this title
p.001155: authorizing the provi- sion of grants, cooperative agreements, or contracts, provide any such financial
p.001155: assistance unless an application for the assistance is submitted to the Secretary and the application is in
p.001155: such form, is made in such manner, and contains such agreements, assurances, and information as the Director
p.001155: determines to be necessary to carry out the program involved.
p.001155: (c) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF FUNDS.—
p.001155: (1) IN GENERAL.—Upon the request of an entity receiving a grant, cooperative agreement, or contract under
p.001155: this title, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for
p.001155: the purpose of aiding the entity in carrying out the project involved and, for such purpose, may detail to
p.001155: the entity any officer or employee of the Department of Health and Human Services.
p.001155: (2) CORRESPONDING REDUCTION IN FUNDS.—With respect to a request described in paragraph (1), the Secretary
p.001155: shall re- duce the amount of the financial assistance involved by an amount equal to the costs of
p.001155: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001155: Director. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001155: expend the amounts withheld.
p.001155: (d) APPLICABILITY OF CERTAIN PROVISIONS WITH RESPECT TO CONTRACTS.—Contracts may be entered into
p.001155: under this part with- out regard to sections 3648 and 3709 of the Revised Statutes (31
p.001155: U.S.C. 529 and 41 U.S.C. 5).
p.001155: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001155:
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p.001157: 1157
p.001157: PUBLIC HEALTH SERVICE ACT
p.001157: Sec. 946
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p.001173: explanation for why the Secretary was unable to com- ply within such 120-day period, as well as a plan of action for
p.001173: consideration of such pending recommendation.
p.001173: (2) DETERMINATIONS TO BE MADE PUBLIC.—The Secretary shall publicize any determination on adopting or
p.001173: rejecting a recommendation of the Advisory Committee pursuant to this subsection, including the justification
p.001173: for the determination.
p.001173: (3) DEADLINE FOR REVIEW.—For each condition nominated to be added to the recommended uniform screening panel
p.001173: in ac- cordance with the requirements of this section, the Advisory Committee shall review and vote on
p.001173: the nominated condition within 9 months of the date on which the Advisory Committee referred the nominated
p.001173: condition to the condition review workgroup.
p.001173: (e) ANNUAL REPORT.—Not later than 3 years after the date of enactment of the Newborn Screening Saves Lives
p.001173: Act of 2008, and each fiscal year thereafter, the Advisory Committee shall—
p.001173: (1) publish a report on peer-reviewed newborn screening guidelines, including follow-up and treatment, in
p.001173: the United States;
p.001173: (2) submit such report to the appropriate committees of Congress, the Secretary, the Interagency
p.001173: Coordinating Com- mittee established under Section 1114, and the State depart- ments of health; and
p.001173: (3) disseminate such report on as wide a basis as prac- ticable, including through posting on the
p.001173: internet clearing- house established under section 1112.
p.001173: (f) MEETINGS.—The Advisory Committee shall meet at least 4 times each calendar year, or at the
p.001173: discretion of the Designated Federal Officer in consultation with the Chair.
p.001173: (g) CONTINUATION OF OPERATION OF COMMITTEE.—
p.001173: (1) IN GENERAL.—Notwithstanding section 14 of the Fed- eral Advisory Committee Act, the Advisory Committee
p.001173: shall continue to operate through the end of fiscal year 2019.
p.001173: (2) CONTINUATION IF NOT REAUTHORIZED.—If at the end of fiscal year 2019 the duration of the Advisory
p.001173: Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of the Federal
p.001173: Advisory Committee Act, an advisory committee established by the President or an offi- cer of the Federal
p.001173: Government under section 9(a) of such Act.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001173:
p.001173:
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p.001173:
p.001173: Sec. 1112 PUBLIC HEALTH SERVICE ACT 1174
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p.001187: (2) to make cash payments to intended recipients of serv- ices provided pursuant to this section;
p.001187: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property);
p.001187: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001187: of Federal funds; or
p.001187:
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p.001187: January 30, 2020
p.001187: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.001187: (b) WAIVER.—The Secretary may waive a restriction under sub- section (a) only if the Secretary determines that the
p.001187: activities out- lined by the State plan submitted under section 1214(a) by the State involved cannot
p.001187: otherwise be carried out.
p.001187: SEC. 1217. ø300d–17¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001187: The Secretary may not make payments under section 1211(a) to a State for a fiscal year unless—
p.001187: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001187: accordance with this part;
p.001187: (2) the agreements are made through certification from the chief executive officer of the State;
p.001187: (3) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001187: Secretary;
p.001187: (4) the application contains the plan provisions and the in- formation required to be submitted to the Secretary
p.001187: pursuant to section 1214; and
p.001187: (5) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001187: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001187: SEC. 1218. ø300d–18¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
p.001187: (a) MINIMUM ALLOTMENT.—Subject to the extent of amounts made available in appropriations Acts, the amount of an
p.001187: allotment under section 1211(a) for a State for a fiscal year shall be the greater of—
p.001187: (1) the amount determined under subsection (b)(1); and
p.001187: (2) $250,000 in the case of each of the several States, the District of Columbia, and the Commonwealth
p.001187: of Puerto Rico,
p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001187:
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p.001189: 1189
p.001189: PUBLIC HEALTH SERVICE ACT
p.001189: Sec. 1218
p.001189:
p.001189: and $50,000 in the case of each of the Virgin Islands, Guam, American Samoa, and the Commonwealth of
p.001189: the Northern Mariana Islands.
p.001189: (b) DETERMINATION UNDER FORMULA.—
p.001189: (1) IN GENERAL.—The amount referred to in subsection (a)(1) for a State for a fiscal year is the sum of—
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p.001189: State) technical assistance with respect to the plan- ning, development, and operation of any program carried
p.001189: out pur- suant to section 1211(b). The Secretary may provide such technical assistance directly, through contract, or
p.001189: through grants.
p.001189: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001189: LIEU OF GRANT FUNDS.—
p.001189: (1) IN GENERAL.—Upon the request of a State receiving payments under section 1211(a), the Secretary may,
p.001189: subject to paragraph (2), provide supplies, equipment, and services for
p.001189: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001191: 1191
p.001191: PUBLIC HEALTH SERVICE ACT
p.001191: Sec. 1231
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p.001191: January 30, 2020
p.001191: the purpose of aiding the State in carrying out section 1211(b) and, for such purpose, may detail to the State
p.001191: any officer or employee of the Department of Health and Human Services.
p.001191: (2) REDUCTION IN PAYMENTS.—With respect to a request described in paragraph (1), the Secretary shall
p.001191: reduce the amount of payments to the State under section 1211(a) by an amount equal to the costs of
p.001191: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001191: Secretary. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001191: expend the amounts withheld.
p.001191: SEC. 1222. ø300d–22¿ REPORT BY SECRETARY.
p.001191: Not later than October 1, 2008, the Secretary shall report to the appropriate committees of Congress on
p.001191: the activities of the States carried out pursuant to section 1211. Such report shall in- clude an
p.001191: assessment of the extent to which Federal and State ef- forts to develop systems of trauma care and to
p.001191: designate trauma centers have reduced the incidence of mortality, and the incidence of permanent
p.001191: disability, resulting from trauma. Such report may include any recommendations of the Secretary for
p.001191: appropriate ad- ministrative and legislative initiatives with respect to trauma care.
p.001191: PART C—GENERAL PROVISIONS REGARDING PARTS A AND B
p.001191: SEC. 1231. ø300d–31¿ DEFINITIONS.
p.001191: For purposes of this part and parts A and B:
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p.001195: of planning and de- veloping approved residency training programs in emergency medi- cine.
p.001195: (b) IDENTIFICATION AND REFERRAL OF DOMESTIC VIOLENCE.— The Secretary may make a grant under subsection
p.001195: (a) only if the applicant involved agrees that the training programs under sub- section (a) will provide
p.001195: education and training in identifying and referring cases of domestic violence.
p.001195: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001195: to be appropriated
p.001195: $400,000 for each of the fiscal years 2008 though 2012.
p.001195: SEC. 1252. ø300d–52¿ STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC BRAIN INJURY.
p.001195: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001195: Living, may make grants to States and American Indian consortia for the purpose of carrying out projects
p.001195: to improve access to rehabilitation and other services regarding traumatic brain injury.
p.001195: (b) STATE ADVISORY BOARD.—
p.001195: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the State or American Indian
p.001195: consortium involved agrees to establish an advisory board within the ap- propriate health department of
p.001195: the State or American Indian consortium or within another department as designated by the chief executive officer
p.001195: of the State or American Indian consor- tium.
p.001195: (2) FUNCTIONS.—An advisory board established under paragraph (1) shall advise and make recommendations
p.001195: to the State or American Indian consortium on ways to improve serv- ices coordination regarding traumatic brain
p.001195: injury. Such advi- sory boards shall encourage citizen participation through the establishment of public
p.001195: hearings and other types of community outreach programs. In developing recommendations under this paragraph, such
p.001195: boards shall consult with Federal, State, and local governmental agencies and with citizens groups and other
p.001195: private entities.
p.001195: (3) COMPOSITION.—An advisory board established under paragraph (1) shall be composed of—
p.001195: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001195:
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p.001197: 1197
p.001197: PUBLIC HEALTH SERVICE ACT
p.001197: Sec. 1252
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p.001235: (A) any sale or exchange, or leasing of any property between the health maintenance organization and a party
p.001235: in interest;
p.001235: (B) any furnishing for consideration of goods, services (including management services), or facilities
p.001235: between the health maintenance organization and a party in interest, but not including salaries paid to
p.001235: employees for services provided in the normal course of their employment and health services provided
p.001235: to members by hospitals and other providers and by staff, medical group (or groups), in- dividual practice
p.001235: association (or associations), or any com- bination thereof; and
p.001235: (C) any lending of money or other extension of credit between a health maintenance organization and a party in
p.001235: interest.
p.001235: The Secretary may require that information reported respecting a health maintenance organization which
p.001235: controls, is controlled by, or is under common control with, another entity be in the form of a
p.001235: consolidated financial statement for the organization and such entity.
p.001235: (b) For the purposes of this section the term ‘‘party in interest’’ means:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235: January 30, 2020
p.001235: (1) any director, officer, partner, or employee responsible for management or administration of a health
p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
p.001235: centum of the equity of the or- ganization, any person who is the beneficial owner of a mort- gage, deed of
p.001235: trust, note, or other interest secured by, and val- uing more than 5 per centum of the health maintenance orga-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001235:
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p.001237: 1237
p.001237: PUBLIC HEALTH SERVICE ACT
p.001237: Sec. 1318
p.001237:
p.001237: nization, and, in the case of a health maintenance organization organized as a nonprofit corporation, an
p.001237: incorporator or mem- ber of such corporation under applicable State corporation law;
p.001237: (2) any entity in which a person described in paragraph (1)—
p.001237: (A) is an officer or director;
p.001237: (B) is a partner (if such entity is organized as a part- nership);
p.001237: (C) has directly or indirectly a beneficial interest of more than 5 per centum of the equity; or
p.001237: (D) has a mortgage, deed of trust, note, or other inter- est valuing more than 5 per centum of the assets of
p.001237: such entity;
p.001237: (3) any person directly or indirectly controlling, controlled by, or under common control with a health
p.001237: maintenance orga- nization; and
p.001237: (4) any spouse, child, or parent of an individual described in paragraph (1).
p.001237: (c) Each health maintenance organization shall make the infor- mation reported pursuant to subsection (a) available to
p.001237: its enrollees upon reasonable request.
p.001237: (d) The Secretary shall, as he deems necessary, conduct an evaluation of transactions reported to the
p.001237: Secretary under sub- section (a)(3) for the purpose of determining their adverse impact, if any, on the
p.001237: fiscal soundness and reasonableness of charges to the health maintenance organization with respect to which they
p.001237: tran- spired. The Secretary shall evaluate the reported transactions of not less than five, or if there are
p.001237: more than twenty health mainte- nance organizations reporting such transactions, not less than one- fourth of the
p.001237: health maintenance organizations reporting any such transactions under subsection (a)(3).
p.001237: (f) 4 Nothing in this section shall be construed to confer upon the Secretary any authority to approve
p.001237: or disapprove the rates charged by any health maintenance organization.
...

p.001245: a description of the manner in which the services and activities will be co- ordinated with any similar
p.001245: services or activities of public and private entities; and
p.001245: (4) the description provides assurances that the grant funds will be used in the most cost-effective
p.001245: manner.
p.001245: SEC. 1506. ø300n–2¿ REQUIREMENT OF SUBMISSION OF APPLICATION.
p.001245: The Secretary may not make a grant under section 1501 unless an application for the grant is submitted to the
p.001245: Secretary, the ap- plication contains the description of intended uses required in sec- tion 1505, and the
p.001245: application is in such form, is made in such manner, and contains such agreements, assurances, and
p.001245: informa- tion as the Secretary determines to be necessary to carry out this title.
p.001245: SEC. 1507. ø300n–3¿ TECHNICAL ASSISTANCE AND PROVISION OF SUP- PLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001245: (a) TECHNICAL ASSISTANCE.—The Secretary may provide train- ing and technical assistance with respect to the
p.001245: planning, develop- ment, and operation of any program or service carried out pursuant to section 1501. The
p.001245: Secretary may provide such technical assist- ance directly or through grants to, or contracts with,
p.001245: public and private entities.
p.001245: (b) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
p.001245: (1) IN GENERAL.—Upon the request of a State receiving a grant under section 1501, the Secretary may,
p.001245: subject to para- graph (2), provide supplies, equipment, and services for the purpose of aiding the State
p.001245: in carrying out such section and, for such purpose, may detail to the State any officer or em- ployee
p.001245: of the Department of Health and Human Services.
p.001245: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001245:
p.001245:
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p.001245: Sec. 1508 PUBLIC HEALTH SERVICE ACT 1246
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p.001245: January 30, 2020
p.001245:
p.001245: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.001245: Secretary shall reduce the amount of payments under the grant under section 1501 to the State involved
p.001245: by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses)
p.001245: and the fair market value of any supplies, equipment, or services provided by the Secretary. The Sec-
p.001245: retary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.001245: SEC. 1508. ø300n–4¿ EVALUATIONS AND REPORTS.
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p.001257: entity to which the facility was sold or transferred—
p.001257: (A) has established an irrevocable trust—
p.001257: (i) in an amount equal to the greater of twice the cost of the remaining obligation of the facility under clause (ii)
p.001257: of section 1621(b)(1)(K) or the amount, determined under subsection (c), that the United States is entitled to
p.001257: recover, and
p.001257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001257:
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p.001257:
p.001257: Sec. 1623 PUBLIC HEALTH SERVICE ACT 1258
p.001257:
p.001257: (ii) which will only be used by the entity to provide the care required by clause (ii) of section 1621(b)(1)(K); and
p.001257: (B) will meet the obligation of the facility under clause (i) of section 1621(b)(1)(K).
p.001257: (2) The Secretary may waive the recovery rights of the United States under subsection (a)(2) with respect to a facility
p.001257: in any State if the Secretary determines, in accordance with regulations, that there is good cause for waiving
p.001257: such rights with respect to such fa- cility.
p.001257: (e) The right of recovery of the United States under subsection
p.001257: (a) shall not constitute a lien on any facility with respect to which funds have been paid under this title.
p.001257: CONTROL OF OPERATIONS
p.001257: SEC. 1623. ø300s–2¿ Except as otherwise specifically provided, nothing in this title shall be construed as conferring
p.001257: on any Federal officer, or employee the right to exercise any supervision or control over the administration,
p.001257: personnel, maintenance, or operation of any facility with respect to which any funds have been or may
p.001257: be expended under this title.
p.001257: DEFINITIONS
p.001257: SEC. 1624. ø300s–3¿ Except as provided in section 1642(e), for purposes of this title—
p.001257: (1) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related facilities,
p.001257: such as labora- tories, outpatient departments, nurses’ home facilities, ex- tended care facilities,
p.001257: facilities related to programs for home health services, self-care units, and central service facilities,
p.001257: operated in connection with hospitals, and also includes edu- cation or training facilities for health
p.001257: professonal 1 personnel operated as an integral part of a hospital, but does not include any hospital furnishing
p.001257: primarily domiciliary care.
p.001257: (2) The term ‘‘public health center’’ means a publicly owned facility for the provision of public
p.001257: health services, in- cluding related publicly owned facilities such as laboratories, clinics, and
p.001257: administrative offices operated in connection with such a facility.
p.001257: (3) The term ‘‘nonprofit’’ as applied to any facility means a facility which is owned and operated by
p.001257: one or more non- profit corporations or associations no part of the net earnings of which inures, or
p.001257: may lawfully inure, to the benefit of any private shareholder or individual.
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p.001279: Behavioral Research 1 (here- inafter in this title referred to as the ‘‘Commission’’) which shall be composed of
p.001279: eleven members appointed by the President. The mem- bers of the Commission shall be appointed as follows:
p.001279: (A) Three of the members shall be appointed from individ- uals who are distinguished in biomedical or behavioral
p.001279: re- search.
p.001279: (B) Three of the members shall be appointed from individ- uals who are distinguished in the practice of medicine or
p.001279: other- wise distinguished in the provision of health care.
p.001279: (C) Five of the members shall be appointed from individ- uals who are distinguished in one or more of the
p.001279: fields of eth-
p.001279:
p.001279:
p.001279:
p.001279:
p.001279: January 30, 2020
p.001279: 1 Such a Commission was established on December 17, 1979, by Executive Order No. 12184 (44 Fed. Reg.
p.001279: 75091). The Executive Order was revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed. Reg.
p.001279: 7237).
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
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p.001279:
p.001281: 1281
p.001281: PUBLIC HEALTH SERVICE ACT
p.001281: Sec. 1802
p.001281:
p.001281: ics, theology, law, the natural sciences (other than a biomedical or behavioral science), the social
p.001281: sciences, the humanities, health administration, government, and public affairs.
p.001281: (2) No individual who is a full-time officer or employee of the United States may be appointed as a
p.001281: member of the Commission. The Secretary of Health, Education, and Welfare, the Secretary of Defense, the
p.001281: Director of Central Intelligence, the Director of the Of- fice of Science and Technology Policy, the
p.001281: Administrator of Vet- erans’ Affairs, and the Director of the National Science Foundation shall each designate an
p.001281: individual to provide liaison with the Com- mission.
p.001281: (3) No individual may be appointed to serve as a member of the Commission if the individual has served
p.001281: for two terms of four years each as such a member.
p.001281: (4) A vacancy in the Commission shall be filled in the manner in which the original appointment was made.
p.001281: (b) TERMS.—(1) Except as provided in paragraphs (2) and (3), members shall be appointed for terms of four
p.001281: years.
p.001281: (2) Of the members first appointed—
p.001281: (A) four shall be appointed for terms of three years, and
p.001281: (B) three shall be appointed for terms of two years, as designated by the President at the time of appointment.
p.001281: (3) Any member appointed to fill a vacancy occurring before the expiration of the term for which his
p.001281: predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the
p.001281: expiration of his term until his successor has taken office.
p.001281: (c) CHAIRMAN.—The Chairman of the Commission shall be ap- pointed by the President, by and with the advice and consent
p.001281: of the Senate, from members of the Commission.
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p.001285: a formula and make such recommendations as the Secretary may deem appropriate in order to ensure the most
p.001285: equitable distribution of funds under allotments under this section.
p.001285:
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p.001285: January 30, 2020
p.001285:
p.001285: PAYMENTS UNDER ALLOTMENTS TO STATES
p.001285: SEC. 1903. ø300w–2¿ (a)(1) For each fiscal year, the Secretary shall make payments, as provided by section 203
p.001285: of the Intergov- ernmental Cooperation Act of 1968 (42 U.S.C. 4213), to each State from its allotment under
p.001285: section 1902 (other than any amount re- served under section 1902(d)) from amounts appropriated for that
p.001285: fiscal year.
p.001285: (2) Any amount paid to a State for a fiscal year and remaining unobligated at the end of such year shall remain
p.001285: available for the next fiscal year to such State for the purposes for which it was made.
p.001285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001285:
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p.001287: 1287
p.001287: PUBLIC HEALTH SERVICE ACT
p.001287: Sec. 1904
p.001287:
p.001287: (b) The Secretary, at the request of a State, may reduce the amount of payments under subsection (a) by—
p.001287: (1) the fair market value of any supplies or equipment fur- nished the State, and
p.001287: (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed
p.001287: to the State and the amount of any other costs incurred in con- nection with the detail of such officer or
p.001287: employee,
p.001287: when the furnishing of supplies or equipment or the detail of an officer or employee is for the
p.001287: convenience of and at the request of the State and for the purpose of conducting activities described
p.001287: in section 1904. The amount by which any payment is so reduced shall be available for payment by the
p.001287: Secretary of the costs in- curred in furnishing the supplies or equipment or in detailing the personnel,
p.001287: on which the reduction of the payment is based, and the amount shall be deemed to be part of the payment and
p.001287: shall be deemed to have been paid to the State.
p.001287:
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p.001287: January 30, 2020
p.001287: USE OF ALLOTMENTS
p.001287: SEC. 1904. ø300w–3¿ (a)(1) Except as provided in subsections
p.001287: (b) and (c), payments made to a State under section 1903 may be used for the following:
p.001287: (A) Activities consistent with making progress toward achieving the objectives established by the
p.001287: Secretary for the health status of the population of the United States for the year 2000 (in this part
p.001287: referred to as ‘‘year 2000 health objec- tives’’).
p.001287: (B) Preventive health service programs for the control of rodents and for community and school-based
p.001287: fluoridation pro- grams.
p.001287: (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and
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p.001289: payments made to the State under section 1903, including a specification of the year 2000 health objectives
p.001289: for which the State will expend the pay- ments.
p.001289: (3) The plan specifies the populations in the State for which such activities are to be carried out.
p.001289: (4) The plan specifies any populations in the State that have a disparate need for such activities.
p.001289: (5) With respect to each population specified under para- graph (3), the plan contains a strategy for expending
p.001289: such pay- ments to carry out such activities to make progress toward im- proving the health status of the population,
p.001289: which strategy in- cludes—
p.001289:
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p.001289: January 30, 2020
p.001289: (A) a description of the programs and projects to be carried out;
p.001289: (B) an estimate of the number of individuals to be served by the programs and projects; and
p.001289: (C) an estimate of the number of public health per- sonnel needed to carry out the strategy.
p.001289: (6) The plan specifies the amount of such payments to be expended for each of such activities and, with
p.001289: respect to the ac- tivity involved—
p.001289: (A) the amount to be expended for each population specified under paragraph (3); and
p.001289: (B) the amount to be expended for each population specified under paragraph (4).
p.001289: (c) STATE CERTIFICATION.—The certification referred to in sub- section (a)(3) for a fiscal year is a
p.001289: certification to the Secretary by the chief executive officer of the State involved as follows:
p.001289: (1)(A) In the development of the State plan required in subsection (a)(2)—
p.001289: (i) the chief health officer of the State held public hearings on the plan; and
p.001289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001289:
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p.001289: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1290
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p.001289:
p.001289: (ii) proposals for the plan were made public in a man- ner that facilitated comments from public and private enti- ties
p.001289: (including Federal and other public agencies).
p.001289: (B) The State agrees that, if any revisions are made in such plan during the fiscal year, the State
p.001289: will, with respect to the revisions, hold hearings and make proposals public in accordance with subparagraph
p.001289: (A), and will submit to the Sec- retary a description of the revisions.
p.001289: (2) The State has established an advisory committee in ac- cordance with subsection (d).
...

p.001289: (i) the State will collect and report data in accordance with section 1906(a); and
p.001289: (ii) for purposes of subparagraph (A), progress will be measured through use of each of the applicable
p.001289: uniform data items developed by the Secretary under paragraph (2) of such section, or if no such items are applicable,
p.001289: through use of the uniform criteria developed by the Secretary under paragraph (3) of such section.
p.001289: (6) With respect to the activities authorized in section 1904, the State agrees to maintain State expenditures
p.001289: for such activities at a level that is not less than the average level of such expenditures maintained
p.001289: by the State for the 2-year pe- riod preceding the fiscal year for which the State is applying to
p.001289: receive payments under section 1903.
p.001289: (7) The State agrees to establish reasonable criteria to evaluate the effective performance of
p.001289: entities that receive funds from such payments and procedures for procedural and substantive independent
p.001289: State review of the failure by the State to provide funds for any such entity.
p.001289: (8) The State agrees to permit and cooperate with Federal investigations undertaken in accordance with section 1907.
p.001289: (9) The State has in effect a system to protect from inap- propriate disclosure patient and sex offense
p.001289: victim records maintained by the State in connection with an activity funded under this part or by any entity
p.001289: which is receiving payments from the allotment of the State under this part.
p.001289: (10) The State agrees to provide the officer of the State government responsible for the administration
p.001289: of the State highway safety program with an opportunity to—
p.001289: (A) participate in the development of any plan by the State relating to emergency medical services, as such
p.001289: plan relates to highway safety; and
p.001289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001289:
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p.001291: 1291
p.001291: PUBLIC HEALTH SERVICE ACT
p.001291: Sec. 1906
p.001291:
p.001291: (B) review and comment on any proposal by any State agency to use any Federal grant or Federal payment re-
p.001291: ceived by the State for the provision of emergency medical services as such proposal relates to highway safety.
p.001291: (d) STATE ADVISORY COMMITTEE.—
p.001291: (1) IN GENERAL.—For purposes of subsection (c)(2), an ad- visory committee is in accordance with this
p.001291: subsection if such committee is known as the State Preventive Health Advisory Committee (in this
p.001291: subsection referred to as the ‘‘Committee’’) and the Committee meets the conditions described in the sub- sequent
p.001291: paragraphs of this subsection.
p.001291: (2) DUTIES.—A condition under paragraph (1) for a State is that the duties of the Committee are—
p.001291: (A) to hold public hearings on the State plan required in subsection (a)(2); and
p.001291: (B) to make recommendations pursuant to subsection (b)(1) regarding the development and implementation of
p.001291: such plan, including recommendations on—
p.001291: (i) the conduct of assessments of the public health;
p.001291: (ii) which of the activities authorized in section 1904 should be carried out in the State;
p.001291: (iii) the allocation of payments made to the State under section 1903;
p.001291: (iv) the coordination of activities carried out under such plan with relevant programs of other entities; and
p.001291:
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p.001291: January 30, 2020
p.001291: (v) the collection and reporting of data in accord- ance with section 1906(a).
p.001291: (3) COMPOSITION.—
p.001291: (A) A condition under paragraph (1) for a State is that the Committee is composed of such members of the general
p.001291: public, and such officials of the health departments of po- litical subdivisions of the State, as may
p.001291: be necessary to provide adequate representation of the general public and of such health departments.
p.001291: (B) With respect to compliance with subparagraph (A), the membership of advisory committees established pursu- ant to
p.001291: subsection (c)(2) may include representatives of community-based organizations (including minority com-
p.001291: munity-based organizations), schools of public health, and entities to which the State involved awards grants or
p.001291: con- tracts to carry out activities authorized in section 1904.
p.001291: (4) CHAIR; MEETINGS.—A condition under paragraph (1) for a State is that the State public health officer
p.001291: serves as the chair of the Committee, and that the Committee meets not less than twice each fiscal year.
p.001291: REPORTS, DATA, AND AUDITS
p.001291: SEC. 1906. ø300w–5¿ (a)(1) For purposes of section 1905(c)(5)(B)(i), a State is collecting and
p.001291: reporting data for a fiscal year in accordance with this subsection if the State submits to the Secretary, not later
p.001291: than February 1 of the succeeding fiscal year, a report that—
p.001291: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001291:
p.001291:
p.001291:
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p.001291:
p.001291: Sec. 1906 PUBLIC HEALTH SERVICE ACT 1292
p.001291:
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p.001291:
p.001291: January 30, 2020
p.001291:
p.001291: (A) describes the purposes for which the State expended payments made to the State under section 1903;
p.001291: (B) pursuant to section 1905(c)(5)(A), describes the extent of progress made by the State for purposes of such
p.001291: section;
...

p.001291: of data on ac- tivities authorized in section 1904 with respect to which no uniform data items exist.
p.001291: (4) A condition under paragraph (1) for a fiscal year is that the State involved will make copies of the report
p.001291: submitted under such paragraph for the fiscal year available for public inspection, and will upon request
p.001291: provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.
p.001291: (b)(1) Each State shall establish fiscal control and fund ac- counting procedures as may be necessary to
p.001291: assure the proper dis- bursal of and accounting for Federal funds paid to the State under section 1903 and funds
p.001291: transferred under section 1904(c) for use under this part.
p.001291: (2) Each State shall annually audit its expenditures from pay- ments received under section 1903. Such State audits
p.001291: shall be con- ducted by an entity independent of any agency administering a pro- gram funded under this part and, in so
p.001291: far as practical, in accord- ance with the Comptroller General’s standards for auditing govern- mental organizations,
p.001291: programs, activities, and functions. Within 30 days following the date each audit is completed, the chief execu-
p.001291: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001291:
p.001291:
p.001291:
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p.001291:
p.001291:
p.001293: 1293
p.001293: PUBLIC HEALTH SERVICE ACT
p.001293: Sec. 1907
p.001293:
p.001293: tive officer of the State shall transmit a copy of that audit to the Secretary.
p.001293: (3) Each State shall, after being provided by the Secretary with adequate notice and opportunity for a hearing
p.001293: within the State, repay to the United States amounts found not to have been ex- pended in accordance with
p.001293: the requirements of this part or the cer- tification provided by the State under section 1905. If such repay-
p.001293: ment is not made, the Secretary shall, after providing the State with adequate notice and opportunity
p.001293: for a hearing within the State, offset such amounts against the amount of any allotment to which the State is or
p.001293: may become entitled under this part.
p.001293: (4) The State shall make copies of the reports and audits re- quired by this section available for
p.001293: public inspection within the State.
p.001293: (5) The Comptroller General of the United States shall, from time to time, evaluate the expenditures by
p.001293: States of grants under this part in order to assure that expenditures are consistent with the provisions
p.001293: of this part and the certification provided by the State under section 1905.
p.001293: (6) Not later than October 1, 1990, the Secretary shall report to the Congress on the activities of
p.001293: the States that have received funds under this part and may include in the report any rec- ommendations
p.001293: for appropriate changes in legislation.
p.001293: (c) Title XVII of the Omnibus Budget Reconciliation Act of 1981 shall not apply with respect to audits of
p.001293: funds allotted under this part.
p.001293:
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p.001293:
p.001293: January 30, 2020
p.001293: NONDISCRIMINATION
p.001293: SEC. 1908. ø300w–7¿ (a)(1) For the purpose of applying the prohibitions against discrimination on the
p.001293: basis of age under the Age Discrimination Act of 1975, on the basis of handicap under sec- tion 504 of the
p.001293: Rehabilitation Act of 1973, on the basis of sex under title IX of the Education Amendments of 1972, or on the
p.001293: basis of race, color, or national origin under title VI of the Civil Rights Act of 1964, programs and activities
p.001293: funded in whole or in part with funds made available under this part are considered to be pro- grams
p.001293: and activities receiving Federal financial assistance.
p.001293: (2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits
p.001293: of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds
p.001293: made available under this part.
p.001293: (b) Whenever the Secretary finds that a State, or an entity that has received a payment from an
p.001293: allotment to a State under section 1902, has failed to comply with a provision of law referred to in subsection
p.001293: (a)(1), with subsection (a)(2), or with an applicable regulation (including one prescribed to carry out subsection
p.001293: (a)(2)), the Secretary shall notify the chief executive officer of the State and shall request him to secure
p.001293: compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer
p.001293: fails or refuses to secure compliance, the Secretary may—
p.001293: (1) refer the matter to the Attorney General with a rec- ommendation that an appropriate civil action be
p.001293: instituted,
p.001293: (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964, the Age
p.001293: Discrimination Act of 1975, or section 504 of the Rehabilitation Act of 1973, as may be applicable, or
p.001293: (3) take such other action as may be provided by law.
p.001293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001293:
p.001293:
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p.001293:
p.001293:
p.001295: 1295
p.001295: PUBLIC HEALTH SERVICE ACT
p.001295: Sec. 1910
p.001295:
p.001295: (c) When a matter is referred to the Attorney General pursuant to subsection (b)(1), or whenever he has reason
p.001295: to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of
p.001295: law referred to in subsection (a)(1) or in violation of subsection (a)(2), the Attorney General may bring a
p.001295: civil action in any appropriate district court of the United States for such relief as may be appropriate, including
p.001295: injunctive relief.
p.001295: CRIMINAL PENALTY FOR FALSE STATEMENTS
p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
...

p.001303: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 1911 is that the
p.001303: State involved will not expend more than 5 percent of the grant for administrative expenses with respect to the grant.
p.001303: SEC. 1917. ø300x–6¿ APPLICATION FOR GRANT.
p.001303: (a) IN GENERAL.—For purposes of section 1911, an application for a grant under such section for a fiscal year
p.001303: in accordance with 4 this section if, subject to subsection (b)—
p.001303: (1) the plan is received by the Secretary not later than September 1 of the fiscal year prior to the fiscal
p.001303: year for which
p.001303:
p.001303:
p.001303:
p.001303:
p.001303: January 30, 2020
p.001303: 4 So in law. See section 201 of Public Law 102–321 (106 Stat. 384). Probably should be ‘‘is in
p.001303: accordance with’’.
p.001303: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001303:
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p.001303:
p.001303: Sec. 1918 PUBLIC HEALTH SERVICE ACT 1304
p.001303:
p.001303: a State is seeking funds, and the report from the previous fis- cal year as required under section 1942(a) is
p.001303: received by De- cember 1 of the fiscal year of the grant;
p.001303: (2) the application contains each funding agreement that is described in this subpart or subpart III for such a grant
p.001303: (other than any such agreement that is not applicable to the State);
p.001303: (3) the agreements are made through certification from the chief executive officer of the State;
p.001303: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001303: Secretary;
p.001303: (5) the application contains the plan required in section 1912(a), the information required in section
p.001303: 1915(b), and the report required in section 1942(a);
p.001303: (6) the application contains recommendations in compli- ance with section 1915(a), or if no such
p.001303: recommendations are received by the State, the application otherwise demonstrates compliance with such section;
p.001303: and
p.001303: (7) the application (including the plan under section 1912(a)) is otherwise in such form, is made
p.001303: in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001303: to carry out this sub- part.
p.001303: (b) WAIVERS REGARDING CERTAIN TERRITORIES.—In the case of any territory of the United States except Puerto Rico, the
p.001303: Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be
p.001303: appropriate, other than the provisions of section 1916.
p.001303: SEC. 1918. ø300x–7¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
p.001303: (a) STATES.—
p.001303: (1) DETERMINATION UNDER FORMULA.—Subject to sub- section (b), the Secretary shall determine the amount of
p.001303: the al- lotment required in section 1911 for a State for a fiscal year in accordance with the following
p.001303: formula:
p.001303:
p.001303: X
p.001303: A ( ) U
p.001303:
p.001303: (2) DETERMINATION OF TERM ‘‘A’’.—For purposes of para- graph (1), the term ‘‘A’’ means the difference between—
p.001303: (A) the amount appropriated under section 1920(a) for allotments under section 1911 for the fiscal year involved; and
p.001303:
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p.001319:
p.001319:
p.001321: 1321
p.001321: PUBLIC HEALTH SERVICE ACT
p.001321: Sec. 1932
p.001321:
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p.001321: January 30, 2020
p.001321: (1) not later than 120 days after the date on which the request is made.
p.001321: SEC. 1932. ø300x–32¿ APPLICATION FOR GRANT; APPROVAL OF STATE PLAN.
p.001321: (a) IN GENERAL.—For purposes of section 1921, an application for a grant under such section for a
p.001321: fiscal year is in accordance with this section if, subject to subsection (c)—
p.001321: (1) the application is received by the Secretary not later than October 1 of the fiscal year for which the
p.001321: State is seeking funds;
p.001321: (2) the application contains each funding agreement that is described in this subpart or subpart III for such a grant
p.001321: (other than any such agreement that is not applicable to the State);
p.001321: (3) the agreements are made through certification from the chief executive officer of the State;
p.001321: (4) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001321: Secretary;
p.001321: (5) the application contains the report required in section 1942(a);
p.001321: (6)(A) the application contains a plan in accordance with subsection (b) and the plan is approved by
p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
...

p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
p.001331:
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p.001331:
p.001331: Sec. 1948 PUBLIC HEALTH SERVICE ACT 1332
p.001331:
p.001331: whole or in part with funds made available under section 1911 or 1921.
p.001331: (b) ENFORCEMENT.—
p.001331: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
p.001331: State and shall request the chief executive officer to secure compliance. If within a reasonable period of
p.001331: time, not to exceed
p.001331: 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
p.001331: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.001331: insti- tuted;
p.001331: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.001331: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.001331: Rights Act of 1964, as may be applicable; or
p.001331: (C) take such other actions as may be authorized by
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
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p.001331:
p.001331:
p.001331:
p.001331: January 30, 2020
p.001331: law.
p.001331: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.001331: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.001331: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.001331: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.001331: the United States for such relief as may be appropriate, including injunc- tive relief.
p.001331: SEC. 1948. ø300x–58¿ TECHNICAL ASSISTANCE AND PROVISION OF SUP- PLIES AND SERVICES IN LIEU OF GRANT FUNDS.
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p.001339: the programs.
p.001339: (2) EVALUATION BY SECRETARY.—In evaluating whether any or all of the conditions described in
p.001339: paragraph (1) have been met, the Secretary shall consult with the National Com- mission on Acquired Immune
p.001339: Deficiency Syndrome.
p.001339: (c) CONDITIONS FOR OBTAINING AUTHORIZATION FROM SEC-
p.001339: RETARY.—
p.001339: (1) IN GENERAL.—In carrying out the requirement estab- lished in subsection (a), the Secretary shall, after
p.001339: consultation with the National Commission on Acquired Immune Deficiency Syndrome, by regulation issue such
p.001339: conditions for treatment programs to obtain authorization from the Secretary to provide interim maintenance
p.001339: treatment as may be necessary to carry out the purpose described in such subsection. Such conditions
p.001339: shall include conditions for preventing the unauthorized use of methadone.
p.001339: (2) COUNSELING ON HIV DISEASE.—The regulations issued under paragraph (1) shall provide that an
p.001339: authorization de- scribed in such paragraph may not be issued to a treatment program unless the program
p.001339: provides to recipients of the treat- ment counseling on preventing exposure to and the trans- mission of HIV
p.001339: disease.
p.001339: (3) PERMISSION OF RELEVANT STATE AS CONDITION OF AU- THORIZATION.—The regulations issued under
p.001339: paragraph (1) shall provide that the Secretary may not provide an authoriza- tion described in such paragraph to any
p.001339: treatment program in a State unless the chief public health officer of the State has certified to the
p.001339: Secretary that—
p.001339: (A) such officer does not object to the provision of such authorizations to treatment programs in the State; and
p.001339: (B) the provision of interim maintenance services in the State will not reduce the capacity of
p.001339: comprehensive treatment programs in the State to admit individuals to the programs (relative to the date on
p.001339: which such officer so certifies).
p.001339: (4) DATE CERTAIN FOR ISSUANCE OF REGULATIONS; FAILURE OF SECRETARY.—The Secretary shall issue the final
p.001339: rule for purposes of the regulations required in paragraph (1), and such rule shall be effective, not later than the
p.001339: expiration of the 180- day period beginning on the date of the enactment of the ADAMHA Reorganization Act
p.001339: 20. If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued
p.001339: on March 2, 1989, with respect to part 291 of title 21, Code of Federal Regulations (docket numbered
p.001339: 88N–0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and
p.001339: the provisions of para- graph (3) of this subsection are deemed to be incorporated into such rule.
p.001339: (d) DEFINITIONS.—For purposes of this section:
p.001339:
p.001339:
p.001339:
p.001339: January 30, 2020
p.001339: 20 Enacted July 10, 1992.
p.001339:
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001339:
p.001339:
p.001339:
p.001339:
p.001339:
p.001339:
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p.001339:
p.001339:
p.001341: 1341
p.001341: PUBLIC HEALTH SERVICE ACT
p.001341: Sec. 2001
p.001341:
p.001341: (1) The term ‘‘interim maintenance services’’ means the provision of methadone in a treatment program under the
p.001341: cir- cumstances described in paragraphs (1) and (2) of subsection (a).
p.001341: (2) The term ‘‘HIV disease’’ means infection with the etio- logic agent for acquired immune deficiency
p.001341: syndrome.
...

p.001353:
p.001353:
p.001353:
p.001353:
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p.001353:
p.001353: C:\XML\SSA-MERGED.XML
p.001353:
p.001353:
p.001355: 1355
p.001355: PUBLIC HEALTH SERVICE ACT
p.001355: Sec. 2011
p.001355:
p.001355: section. The recipient may utilize reprints of articles published or accepted for publication in
p.001355: professional journals to supplement or replace such report if the research contained in such articles was
p.001355: supported under this section during the year for which the report is required.
p.001355: (B) In the case of any research project for which assistance is provided under this section for two or
p.001355: more consecutive one-year periods, the recipient of such assistance shall prepare and transmit the report required
p.001355: by subparagraph (A) to the Secretary not later than twelve months after the end of each one-year period for which such
p.001355: funding is provided.
p.001355: (2) Recipients of grants and contracts for dissemination under this section shall submit to the Secretary
p.001355: such reports as the Sec- retary determines appropriate.
p.001355: EVALUATION AND ADMINISTRATION
p.001355: SEC. 2009. ø300z–8¿ (a) Of the funds appropriated under this title, the Secretary shall reserve not less
p.001355: than 1 per centum and not more than 3 per centum for the evaluation of activities carried out under this title. The
p.001355: Secretary shall submit to the appropriate committees of the Congress a summary of each evaluation con- ducted
p.001355: under this section.
p.001355: (b) The officer or employee of the Department of Health and Human Services designated by the Secretary to
p.001355: carry out the provi- sions of this title shall report directly to the Assistant Secretary for Health with respect to
p.001355: the activities of such officer or employee in carrying out such provisions.
p.001355: AUTHORIZATION OF APPROPRIATIONS
p.001355: SEC. 2010. ø300z–9¿ (a) For the purpose of carrying out this title, there are authorized to be
p.001355: appropriated $30,000,000 for the fiscal year ending September 30, 1982, $30,000,000 for the fiscal year
p.001355: ending September 30, 1983, $30,000,000 for the fiscal year ending September 30, 1984, and $30,000,000 for
p.001355: the fiscal year ending September 30, 1985.
p.001355: (b) At least two-thirds of the amounts appropriated to carry out this title shall be used to make
p.001355: grants for demonstration projects for services.
p.001355: (c) Not more than one-third of the amounts specified under subsection (b) for use for grants for demonstration
p.001355: projects for serv- ices shall be used for grants for demonstration projects for preven- tion services.
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355:
p.001355: January 30, 2020
p.001355: RESTRICTIONS
p.001355: SEC. 2011. ø300z–10¿ (a) Grants or payments may be made only to programs or projects which do not
p.001355: provide abortions or abortion counseling or referral, or which do not subcontract with or make any payment to any
p.001355: person who provides abortions or abor- tion counseling or referral, except that any such program or project may
p.001355: provide referral for abortion counseling to a pregnant adoles- cent if such adolescent and the parents or
p.001355: guardians of such adoles- cent request such referral; and grants may be made only to projects
p.001355: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001355:
p.001355:
...

p.001421: home and community-based health services provided by entities that re- ceive funds from the State pursuant to
p.001421: section 2401(a);
p.001421: (4) the State will permit and cooperate with Federal inves- tigations undertaken under section 2409(e);
p.001421: (5) the State will maintain State expenditures for home and community-based health services for
p.001421: individuals infected with the etiologic agent for acquired immune deficiency syn- drome at a level equal
p.001421: to not less than the average level of such expenditures maintained by the State for the 2-year pe- riod
p.001421: preceding the fiscal year for which the State is applying to receive payments; and
p.001421: (6) the State will not make payments from allotments made under section 2401(a) for any item or service
p.001421: to the ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect
p.001421: to that item or service (i) under any State compensation program, under an insurance policy, under any
p.001421: Federal or State health benefits program, or
p.001421: (ii) by an entity that provides health services on a prepaid basis.
p.001421: SEC. 2407. ø300dd–6¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001421: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001421: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001421: accordance with sec- tions 2401 through 2406;
p.001421: (2) the agreements are made through certification from the chief executive officer of the State;
p.001421: (3) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001421: Secretary;
p.001421: (4) the application contains the description of intended ex- penditures required in section 2403; and
p.001421: (5) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001421: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001421: SEC. 2408. ø300dd–7¿ DETERMINATION OF AMOUNT OF ALLOTMENTS FOR STATES.
p.001421: (a) MINIMUM ALLOTMENT.—Subject to the extent of amounts made available in appropriations Acts, the amount of an
p.001421: allotment under section 2401(a) for—
p.001421: (1) each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, for a
p.001421: fiscal year shall be the greater of—
p.001421: (A) $100,000, and
p.001421: (B) an amount determined under subsection (b); and
p.001421: (2) each territory of the United States (as defined in sec- tion 2413(5)) shall be $25,000.
p.001421: (b) DETERMINATION UNDER FORMULA.—
p.001421: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001421:
p.001421:
p.001421:
p.001421:
p.001421:
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p.001421:
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p.001421:
p.001421:
p.001423: 1423
p.001423: PUBLIC HEALTH SERVICE ACT
p.001423: Sec. 2408
p.001423:
p.001423: (1) The amount referred to in subsection (a)(1)(B) for a State is the product of—
p.001423: (A) an amount equal to the amount appropriated pur- suant to section 2414(a) for the fiscal year involved; and
...

p.001425: (a) IN GENERAL.—A person may not knowingly make or cause to be made any false statement or representation of a
p.001425: material fact in connection with the furnishing of items or services for which amounts may be paid by a
p.001425: State from payments received by the State under section 2401(a).
p.001425: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.001425: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001425: for not more than 5 years, or both.
p.001425: SEC. 2411. ø300dd–10¿ TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001425: LIEU OF GRANT FUNDS.
p.001425: (a) TECHNICAL ASSISTANCE.—Upon the request of a State re- ceiving payments under section 2401(a), the
p.001425: Secretary may, with- out charge to the State, provide to the State (or to any public or private entity
p.001425: designated by the State) technical assistance with re- spect to the planning, development, and operation of any
p.001425: program or service carried out pursuant to this part. The Secretary may pro- vide such technical assistance
p.001425: directly, through contract, or through grants.
p.001425: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001425: LIEU OF GRANT FUNDS.—
p.001425: (1) Upon the request of a State receiving payments under section 2401(a), the Secretary may, subject to
p.001425: paragraph (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying
p.001425: out this part and, for such pur- pose, may detail to the State any officer or employee of the De- partment of
p.001425: Health and Human Services.
p.001425: (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments
p.001425: under sec- tion 2401(a) to the State by an amount equal to the costs of
p.001425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001425:
p.001425:
p.001425:
p.001425:
p.001425:
p.001425:
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p.001425:
p.001425: Sec. 2412 PUBLIC HEALTH SERVICE ACT 1426
p.001425:
p.001425: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001425: Secretary. The Sec- retary shall, for the payment of expenses incurred in complying with such request, expend the
p.001425: amounts withheld.
p.001425: SEC. 2412. ø300dd–11¿ REPORT BY SECRETARY.
p.001425: Not later than March 1, 1990, the Secretary shall report to the Congress on the activities of the States under
p.001425: this part. Such re- port shall include a recommendation as to whether or not the pro- gram under this part
p.001425: should be extended beyond fiscal year 1990 and may include any recommendations of the Secretary for
p.001425: appro- priate administrative and legislative initiatives.
p.001425: SEC. 2413. ø300dd–12¿ DEFINITIONS.
p.001425: For purposes of this part:
p.001425: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such terms in sections
...

p.001431: SEC. 2503. ø300ee–13¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001431: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless—
p.001431: (1) the State involved submits to the Secretary a descrip- tion of the purposes for which the State intends to
p.001431: expend the payments for the fiscal year;
p.001431: (2) the description identifies the populations, areas, and lo- calities in the State with a need for the
p.001431: services for which amounts may be provided by the State under this part;
p.001431:
p.001431:
p.001431:
p.001431: January 30, 2020
p.001431: 2 So in law. Probably should be ‘‘data’’.
p.001431:
p.001431: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001431:
p.001431:
p.001431:
p.001431:
p.001431:
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p.001431:
p.001431:
p.001433: 1433
p.001433: PUBLIC HEALTH SERVICE ACT
p.001433: Sec. 2505
p.001433:
p.001433: (3) the description provides information relating to the pro- grams and activities to be supported and services
p.001433: to be pro- vided, including a description of the manner in which such pro- grams and activities will be
p.001433: coordinated with any similar pro- grams and activities of public and private entities;
p.001433: (4) the State submits to the Secretary an application for the payments containing agreements in
p.001433: accordance with this part;
p.001433: (5) the agreements are made through certification from the chief executive officer of the State;
p.001433: (6) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001433: the Secretary; and
p.001433:
p.001433:
p.001433:
p.001433:
p.001433:
p.001433:
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p.001433:
p.001433:
p.001433:
p.001433:
p.001433:
p.001433:
p.001433: January 30, 2020
p.001433: (7) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001433: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001433: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 2501(a) for a
p.001433: fiscal year unless the State involved agrees that, in developing and carrying out the description required
p.001433: in subsection (a), the State will provide public notice with respect to the description (including any revisions) and
p.001433: will facilitate comments from interested persons.
p.001433: SEC. 2504. ø300ee–14¿ RESTRICTIONS ON USE OF GRANT.
p.001433: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless
p.001433: the State involved agrees that the payments will not be expended—
p.001433: (1) to provide inpatient services;
p.001433: (2) to make cash payments to intended recipients of serv- ices;
...

p.001439: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.001439: payments received by the State under section 2501(a).
p.001439: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.001439: amounts from payments made to the State under section 2501(a) may not conceal or fail to disclose any
p.001439: such event with the intent of fraudulently securing such amounts.
p.001439: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.001439: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001439: for not more than 5 years, or both.
p.001439: SEC. 2510. ø300ee–20¿ TECHNICAL ASSISTANCE AND PROVISION BY SECRETARY OF SUPPLIES AND SERVICES
p.001439: IN LIEU OF GRANT FUNDS.
p.001439: (a) TECHNICAL ASSISTANCE.—The Secretary may provide train- ing and technical assistance to States with respect to
p.001439: the planning, development, and operation of any program or service carried out pursuant to this part. The
p.001439: Secretary may provide such technical as- sistance directly or through grants or contracts.
p.001439: (b) PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN
p.001439: LIEU OF GRANT FUNDS.—
p.001439: (1) Upon the request of a State receiving payments under this part, the Secretary may, subject to paragraph
p.001439: (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying out such part and, for
p.001439: such purpose, may de- tail to the State any officer or employee of the Department of Health and Human
p.001439: Services.
p.001439: (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments
p.001439: under sec- tion 2501(a) to the State by an amount equal to the costs of detailing personnel and the
p.001439: fair market value of any supplies, equipment, or services provided by the Secretary. The Sec- retary
p.001439: shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.001439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001439:
p.001439:
p.001439:
p.001439:
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p.001439:
p.001439: Sec. 2511 PUBLIC HEALTH SERVICE ACT 1440
p.001439:
p.001439:
p.001439:
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p.001439:
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p.001439:
p.001439:
p.001439: January 30, 2020
p.001439:
p.001439: SEC. 2511. ø300ee–21¿ EVALUATIONS.
p.001439: The Secretary shall, directly or through grants or contracts, evaluate the services provided and
...

p.001503: study is submitted to the ap- propriate committees of the Congress, the Secretary, and the chief public health
p.001503: official of each of the States.
p.001503: (b) PROGRESS TOWARD RECOMMENDATIONS.—In fiscal year 2004, the Secretary shall collect information
p.001503: from the States de- scribing the actions taken by the States toward meeting the rec- ommendations
p.001503: specified for the States under subsection (a)(1)(C).
p.001503: (c) SUBMISSION OF REPORTS TO CONGRESS.—The Secretary shall submit to the appropriate committees of the
p.001503: Congress reports describing the information collected under subsection (b).
p.001503:
p.001503: Subpart III—Certain Partner Notification Programs
p.001503:
p.001503:
p.001503:
p.001503:
p.001503:
p.001503:
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p.001503:
p.001503:
p.001503: January 30, 2020
p.001503: SEC. 2631. ø300ff–38¿ GRANTS FOR PARTNER NOTIFICATION PRO- GRAMS.
p.001503: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001503: (b), the Secretary, subject to subsection (c)(2), may make grants to the States for carrying out programs to provide
p.001503: partner counseling and referral services.
p.001503: (b) DESCRIPTION OF COMPLIANT STATE PROGRAMS.—For pur- poses of subsection (a), the laws or regulations of a
p.001503: State are in ac- cordance with this subsection if under such laws or regulations (in- cluding programs carried out
p.001503: pursuant to the discretion of State of- ficials) the following policies are in effect:
p.001503: (1) The State requires that the public health officer of the State carry out a program of partner notification
p.001503: to inform partners of individuals with HIV/AIDS that the partners may have been exposed to the disease.
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001503:
p.001503:
p.001503:
p.001503:
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p.001503:
p.001503:
p.001505: 1505
p.001505: PUBLIC HEALTH SERVICE ACT
p.001505: Sec. 2631
p.001505:
p.001505:
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p.001505:
p.001505: January 30, 2020
p.001505: (2)(A) In the case of a health entity that provides for the performance on an individual of a test
p.001505: for HIV/AIDS, or that treats the individual for the disease, the State requires, subject to subparagraph (B),
p.001505: that the entity confidentially report the positive test results to the State public health officer in a man- ner
p.001505: recommended and approved by the Director of the Centers for Disease Control and Prevention, together with such
p.001505: addi- tional information as may be necessary for carrying out such program.
p.001505: (B) The State may provide that the requirement of sub- paragraph (A) does not apply to the testing of an
p.001505: individual for HIV/AIDS if the individual underwent the testing through a program designed to perform the
p.001505: test and provide the results to the individual without the individual disclosing his or her identity to
p.001505: the program. This subparagraph may not be con- strued as affecting the requirement of subparagraph (A)
p.001505: with respect to a health entity that treats an individual for HIV/ AIDS.
p.001505: (3) The program under paragraph (1) is carried out in ac- cordance with the following:
p.001505: (A) Partners are provided with an appropriate oppor- tunity to learn that the partners have been exposed
p.001505: to HIV/AIDS, subject to subparagraph (B).
p.001505: (B) The State does not inform partners of the identity of the infected individuals involved.
p.001505: (C) Counseling and testing for HIV/AIDS are made available to the partners and to infected individuals,
p.001505: and such counseling includes information on modes of trans- mission for the disease, including information
p.001505: on prenatal and perinatal transmission and preventing transmission.
p.001505: (D) Counseling of infected individuals and their part- ners includes the provision of information regarding
...

p.001517: services are consistent with the guidelines; and
p.001517: (B) to ensure that improvements in the access to and quality of HIV health services are addressed.
p.001517: SEC. 2665. ø300ff–65¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001517: The Secretary may not make a grant under this part unless—
p.001517: (1) an application for the grant is submitted to the Sec- retary containing agreements and assurances in
p.001517: accordance with this part and containing the information specified in sec- tion 2664(a)(1);
p.001517: (2) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001517: the Secretary; and
p.001517:
p.001517:
p.001517:
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p.001517: January 30, 2020
p.001517: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001517: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001517: SEC. 2666. ø300ff–66¿ PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
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p.001531: (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this part, the Secretary shall
p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
p.001531: (b) SPECIFICATION OF AIRBORNE INFECTIOUS DISEASES.—The list developed by the Secretary under subsection (a)(1)
p.001531: shall include a specification of those infectious diseases on the list that are rou- tinely transmitted through
p.001531: airborne or aerosolized means.
p.001531: (c) DISSEMINATION.—The Secretary shall—
p.001531: (1) transmit to State public health officers copies of the list and guidelines developed by the Secretary under
p.001531: subsection (a) with the request that the officers disseminate such copies as appropriate throughout the
p.001531: States; and
p.001531: (2) make such copies available to the public.
p.001531: SEC. 2695A. ø300ff–132¿ ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE INFECTIOUS DISEASES IN VICTIMS ASSISTED.
p.001531: (a) ROUTINE NOTIFICATION OF DESIGNATED OFFICER.—
p.001531: (1) DETERMINATION BY TREATING FACILITY.—If a victim of an emergency is transported by emergency response
p.001531: employees to a medical facility and the medical facility makes a deter- mination that the victim has an
p.001531: airborne infectious disease,
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001531: Sec. 2695B PUBLIC HEALTH SERVICE ACT 1532
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p.001531: the medical facility shall notify the designated officer of the emergency response employees who
p.001531: transported the victim to the medical facility of the determination.
p.001531: (2) DETERMINATION BY FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim of an emergency is transported
p.001531: by emer- gency response employees to a medical facility and the victim dies at or before reaching the
p.001531: medical facility, the medical fa- cility ascertaining the cause of death shall notify the des- ignated
p.001531: officer of the emergency response employees who trans- ported the victim to the initial medical facility of
p.001531: any deter- mination by the medical facility that the victim had an air- borne infectious disease.
p.001531: (b) REQUIREMENT OF PROMPT NOTIFICATION.—With respect to a determination described in paragraph (1) or (2) of
p.001531: subsection (a), the notification required in each of such paragraphs shall be made as soon as is practicable, but not
p.001531: later than 48 hours after the de- termination is made.
p.001531: SEC. 2695B. ø300ff–133¿ REQUEST FOR NOTIFICATION WITH RESPECT TO VICTIMS ASSISTED.
p.001531: (a) INITIATION OF PROCESS BY EMPLOYEE.—If an emergency re- sponse employee believes that the employee may
p.001531: have been ex- posed to an infectious disease by a victim of an emergency who was transported to a medical facility as
p.001531: a result of the emergency, and if the employee attended, treated, assisted, or transported the vic- tim
p.001531: pursuant to the emergency, then the designated officer of the employee shall, upon the request of the
p.001531: employee, carry out the du- ties described in subsection (b) regarding a determination of wheth- er the employee may
p.001531: have been exposed to an infectious disease by the victim.
p.001531: (b) INITIAL DETERMINATION BY DESIGNATED OFFICER.—The du- ties referred to in subsection (a) are that—
p.001531: (1) the designated officer involved collect the facts relating to the circumstances under which, for purposes of
p.001531: subsection (a), the employee involved may have been exposed to an infec- tious disease; and
p.001531: (2) the designated officer evaluate such facts and make a determination of whether, if the victim involved had
p.001531: any infec- tious disease included on the list issued under paragraph (1) of section 2695(a), the employee
p.001531: would have been exposed to the disease under such facts, as indicated by the guidelines issued under
p.001531: paragraph (2) of such section.
p.001531: (c) SUBMISSION OF REQUEST TO MEDICAL FACILITY.—
p.001531: (1) IN GENERAL.—If a designated officer makes a deter- mination under subsection (b)(2) that an emergency
p.001531: response employee may have been exposed to an infectious disease, the designated officer shall submit to the
p.001531: medical facility to which the victim involved was transported a request for a response under subsection (d)
p.001531: regarding the victim of the emergency in- volved.
p.001531: (2) FORM OF REQUEST.—A request under paragraph (1) shall be in writing and be signed by the designated
p.001531: officer in- volved, and shall contain a statement of the facts collected pur- suant to subsection (b)(1).
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: 1533
p.001533: PUBLIC HEALTH SERVICE ACT
p.001533: Sec. 2695B
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p.001533: January 30, 2020
p.001533: (d) EVALUATION AND RESPONSE REGARDING REQUEST TO MED-
p.001533: ICAL FACILITY.—
p.001533: (1) IN GENERAL.—If a medical facility receives a request under subsection (c), the medical facility shall
p.001533: evaluate the facts submitted in the request and make a determination of whether, on the basis of the medical
p.001533: information possessed by the facility regarding the victim involved, the emergency re- sponse employee was
p.001533: exposed to an infectious disease included on the list issued under paragraph (1) of section 2695(a), as in- dicated by
p.001533: the guidelines issued under paragraph (2) of such section.
p.001533: (2) NOTIFICATION OF EXPOSURE.—If a medical facility makes a determination under paragraph (1) that
p.001533: the emer- gency response employee involved has been exposed to an in- fectious disease, the medical facility
p.001533: shall, in writing, notify the designated officer who submitted the request under subsection
p.001533: (c) of the determination.
p.001533: (3) FINDING OF NO EXPOSURE.—If a medical facility makes a determination under paragraph (1) that the
p.001533: emergency re- sponse employee involved has not been exposed to an infectious disease, the medical facility shall,
p.001533: in writing, inform the des- ignated officer who submitted the request under subsection (c) of the determination.
p.001533: (4) INSUFFICIENT INFORMATION.—
p.001533: (A) If a medical facility finds in evaluating facts for purposes of paragraph (1) that the facts are
p.001533: insufficient to make the determination described in such paragraph, the medical facility shall, in writing,
p.001533: inform the designated of- ficer who submitted the request under subsection (c) of the insufficiency of the facts.
p.001533: (B)(i) If a medical facility finds in making a deter- mination under paragraph (1) that the facility possesses
p.001533: no information on whether the victim involved has an infec- tious disease included on the list under
p.001533: section 2695(a), the medical facility shall, in writing, inform the designated officer who submitted the request
p.001533: under subsection (c) of the insufficiency of such medical information.
p.001533: (ii) If after making a response under clause (i) a med- ical facility determines that the victim involved has an in-
p.001533: fectious disease, the medical facility shall make the deter- mination described in paragraph (1) and provide the appli-
p.001533: cable response specified in this subsection.
p.001533: (e) TIME FOR MAKING RESPONSE.—After receiving a request under subsection (c) (including any such request
p.001533: resubmitted under subsection (g)(2)), a medical facility shall make the applicable re- sponse specified in
p.001533: subsection (d) as soon as is practicable, but not later than 48 hours after receiving the request.
p.001533: (f) DEATH OF VICTIM OF EMERGENCY.—
p.001533: (1) FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim described in subsection (a) dies at or before reaching the
p.001533: med- ical facility involved, and the medical facility receives a request under subsection (c), the medical
p.001533: facility shall provide a copy of the request to the medical facility ascertaining the cause of
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: Sec. 2695B PUBLIC HEALTH SERVICE ACT 1534
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p.001533: death of the victim, if such facility is a different medical facil- ity than the facility that received the original
p.001533: request.
p.001533: (2) RESPONSIBILITY OF FACILITY.—Upon the receipt of a copy of a request for purposes of paragraph (1), the
p.001533: duties oth- erwise established in this part regarding medical facilities shall apply to the medical
p.001533: facility ascertaining the cause of death of the victim in the same manner and to the same extent as such duties
p.001533: apply to the medical facility originally receiving the request.
p.001533: (g) ASSISTANCE OF PUBLIC HEALTH OFFICER.—
p.001533: (1) EVALUATION OF RESPONSE OF MEDICAL FACILITY RE- GARDING INSUFFICIENT FACTS.—
p.001533: (A) In the case of a request under subsection (c) to which a medical facility has made the response specified
p.001533: in subsection (d)(4)(A) regarding the insufficiency of facts, the public health officer for the community in which the
p.001533: med- ical facility is located shall evaluate the request and the response, if the designated officer
p.001533: involved submits such documents to the officer with the request that the officer make such an evaluation.
p.001533: (B) As soon as is practicable after a public health offi- cer receives a request under subparagraph (A), but
p.001533: not later than 48 hours after receipt of the request, the public health officer shall complete the evaluation
p.001533: required in such paragraph and inform the designated officer of the re- sults of the evaluation.
p.001533: (2) FINDINGS OF EVALUATION.—
p.001533: (A) If an evaluation under paragraph (1)(A) indicates that the facts provided to the medical facility
p.001533: pursuant to subsection (c) were sufficient for purposes of determina- tions under subsection (d)(1)—
p.001533: (i) the public health officer shall, on behalf of the designated officer involved, resubmit the request
p.001533: to the medical facility; and
p.001533: (ii) the medical facility shall provide to the des- ignated officer the applicable response specified
p.001533: in subsection (d).
p.001533: (B) If an evaluation under paragraph (1)(A) indicates that the facts provided in the request to the medical
p.001533: facil- ity were insufficient for purposes of determinations speci- fied in subsection (c)—
p.001533: (i) the public health officer shall provide advice to the designated officer regarding the collection and de- scription
p.001533: of appropriate facts; and
p.001533: (ii) if sufficient facts are obtained by the des- ignated officer—
p.001533: (I) the public health officer shall, on behalf of the designated officer involved, resubmit the re- quest to the
p.001533: medical facility; and
p.001533: (II) the medical facility shall provide to the designated officer the appropriate response under subsection
p.001533: (c).
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: 1535
p.001535: PUBLIC HEALTH SERVICE ACT
p.001535: Sec. 2695E
p.001535:
p.001535: SEC. 2695C. ø300ff–134¿ PROCEDURES FOR NOTIFICATION OF EXPO- SURE.
p.001535: (a) CONTENTS OF NOTIFICATION TO OFFICER.—In making a no- tification required under section 2695A or section
p.001535: 2695B(d)(2), a medical facility shall provide—
p.001535: (1) the name of the infectious disease involved; and
p.001535: (2) the date on which the victim of the emergency involved was transported by emergency response employees to the med-
p.001535: ical facility involved.
p.001535: (b) MANNER OF NOTIFICATION.—If a notification under section 2695A or section 2695B(d)(2) is mailed or
p.001535: otherwise indirectly made—
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p.001535: (1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer
p.001535: to whom the notification is sent of the fact that the notification has been sent; and
p.001535: (2) such designated officer shall, not later than 10 days after being informed by the medical facility
p.001535: that the notifica- tion has been sent, inform such medical facility whether the designated officer has
p.001535: received the notification.
p.001535: SEC. 2695D. ø300ff–135¿ NOTIFICATION OF EMPLOYEE.
p.001535: (a) IN GENERAL.—After receiving a notification for purposes of section 2695A or 2695B(d)(2), a designated officer of
p.001535: emergency re- sponse employees shall, to the extent practicable, immediately no- tify each of such employees
p.001535: who—
p.001535: (1) responded to the emergency involved; and
p.001535: (2) as indicated by guidelines developed by the Secretary, may have been exposed to an infectious disease.
p.001535: (b) CERTAIN CONTENTS OF NOTIFICATION TO EMPLOYEE.—A no- tification under this subsection to an emergency response
p.001535: employee shall inform the employee of—
p.001535: (1) the fact that the employee may have been exposed to an infectious disease and the name of the disease
p.001535: involved;
p.001535: (2) any action by the employee that, as indicated by guide- lines developed by the Secretary, is medically appropriate;
p.001535: and
p.001535: (3) if medically appropriate under such criteria, the date of such emergency.
p.001535: (c) RESPONSES OTHER THAN NOTIFICATION OF EXPOSURE.— After receiving a response under paragraph (3) or (4) of
p.001535: subsection
p.001535: (d) of section 2695B, or a response under subsection (g)(1) of such section, the designated officer for the
p.001535: employee shall, to the extent practicable, immediately inform the employee of the response.
p.001535: SEC. 2695E. ø300ff–136¿ SELECTION OF DESIGNATED OFFICERS.
p.001535: (a) IN GENERAL.—For the purposes of receiving notifications and responses and making requests under this
p.001535: part on behalf of emergency response employees, the public health officer of each State shall designate 1
p.001535: official or officer of each employer of emer- gency response employees in the State.
p.001535: (b) PREFERENCE IN MAKING DESIGNATIONS.—In making the designations required in subsection (a), a public health
p.001535: officer shall give preference to individuals who are trained in the provision of health care or in the
p.001535: control of infectious diseases.
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: Sec. 2695F PUBLIC HEALTH SERVICE ACT 1536
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p.001535: SEC. 2695F. ø300ff–137¿ LIMITATION WITH RESPECT TO DUTIES OF MEDICAL FACILITIES.
p.001535: The duties established in this part for a medical facility—
p.001535: (1) shall apply only to medical information possessed by the facility during the period in which the
p.001535: facility is treating the victim for conditions arising from the emergency, or during the 60-day period beginning
p.001535: on the date on which the victim is transported by emergency response employees to the facility, whichever period
p.001535: expires first; and
p.001535: (2) shall not apply to any extent after the expiration of the 30-day period beginning on the expiration of the
p.001535: applicable pe- riod referred to in paragraph (1), except that such duties shall apply with respect to any request
p.001535: under section 2695B(c) re- ceived by a medical facility before the expiration of such 30-day period.
p.001535: SEC. 2695G. ø300ff–138¿ MISCELLANEOUS PROVISIONS.
p.001535: (a) LIABILITY OF MEDICAL FACILITIES, DESIGNATED OFFICERS, PUBLIC HEALTH OFFICERS, AND GOVERNING
p.001535: ENTITIES.—This part may not be construed to authorize any cause of action for damages or any civil penalty against any
p.001535: medical facility, any designated of- ficer, any other public health officer, or any governing entity of such
p.001535: facility or officer for failure to comply with the duties estab- lished in this part.
p.001535: (b) TESTING.—This part may not, with respect to victims of emergencies, be construed to authorize or require a
p.001535: medical facility to test any such victim for any infectious disease.
p.001535: (c) CONFIDENTIALITY.—This part may not be construed to au- thorize or require any medical facility, any
p.001535: designated officer of emergency response employees, or any such employee, to disclose identifying information
p.001535: with respect to a victim of an emergency or with respect to an emergency response employee.
p.001535: (d) FAILURE TO PROVIDE EMERGENCY SERVICES.—This part may not be construed to authorize any emergency
p.001535: response em- ployee to fail to respond, or to deny services, to any victim of an emergency.
p.001535: (e) NOTIFICATION AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or
p.001535: partially as a result of a public health emergency that has been determined pursuant to section 319(a),
p.001535: individuals or public or private entities are un- able to comply with the requirements of this part,
p.001535: the Secretary may, notwithstanding any other provision of law, temporarily sus- pend, in whole or in part, the
p.001535: requirements of this part as the cir- cumstances reasonably require. Before or promptly after such a
p.001535: suspension, the Secretary shall notify the Congress of such action and publish in the Federal Register a
p.001535: notice of the suspension.
p.001535: (f) CONTINUED APPLICATION OF STATE AND LOCAL LAW.—Noth- ing in this part shall be construed to limit the
p.001535: application of State or local laws that require the provision of data to public health au- thorities.
p.001535: SEC. 2695H. ø300ff–139¿ INJUNCTIONS REGARDING VIOLATION OF PRO- HIBITION.
p.001535: (a) IN GENERAL.—The Secretary may, in any court of com- petent jurisdiction, commence a civil action for
p.001535: the purpose of ob-
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001535:
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p.001537: 1537
p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
p.001537:
p.001537: taining temporary or permanent injunctive relief with respect to any violation of this part.
p.001537: (b) FACILITATION OF INFORMATION ON VIOLATIONS.—The Sec- retary shall establish an administrative process
p.001537: for encouraging emergency response employees to provide information to the Sec- retary regarding violations
p.001537: of this part. As appropriate, the Sec- retary shall investigate alleged such violations and seek appro-
p.001537: priate injunctive relief.
p.001537: SEC. 2695I. ø300ff–140¿ APPLICABILITY OF PART.
p.001537: This part shall not apply in a State if the chief executive officer of the State certifies to the Secretary that
p.001537: the law of the State is substantially consistent with this part.
p.001537: TITLE XXVII—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
p.001537:
p.001537: PART A—INDIVIDUAL AND GROUP MARKET REFORMS
p.001537: Subpart I—General Reform
p.001537: SEC. 2701. ø300gg¿ FAIR HEALTH INSURANCE PREMIUMS.
p.001537: (a) 1 PROHIBITING DISCRIMINATORY PREMIUM RATES.—
p.001537: (1) IN GENERAL.—With respect to the premium rate charged by a health insurance issuer for health
p.001537: insurance cov- erage offered in the individual or small group market—
p.001537: (A) such rate shall vary with respect to the particular plan or coverage involved only by—
p.001537: (i) whether such plan or coverage covers an indi- vidual or family;
p.001537: (ii) rating area, as established in accordance with paragraph (2);
p.001537: (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with
p.001537: section 2707(c)); and
p.001537: (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
p.001537: (B) such rate shall not vary with respect to the par- ticular plan or coverage involved by any other
p.001537: factor not described in subparagraph (A).
p.001537: (2) RATING AREA.—
p.001537: (A) IN GENERAL.—Each State shall establish 1 or more rating areas within that State for purposes of applying the
p.001537: requirements of this title.
p.001537: (B) SECRETARIAL REVIEW.—The Secretary shall review the rating areas established by each State under subpara- graph
p.001537: (A) to ensure the adequacy of such areas for pur- poses of carrying out the requirements of this
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p.001591:
p.001591: Sec. 2723 PUBLIC HEALTH SERVICE ACT 1592
p.001591: (F) FAILURE TO PAY ASSESSMENT; MAINTENANCE OF AC- TION.—
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p.001591: January 30, 2020
p.001591: (i) FAILURE TO PAY ASSESSMENT.—If any entity fails to pay an assessment after it has become a final and
p.001591: unappealable order, or after the court has entered final judgment in favor of the Secretary, the Secretary shall refer
p.001591: the matter to the Attorney General who shall recover the amount assessed by action in the ap- propriate United
p.001591: States district court.
p.001591: (ii) NONREVIEWABILITY.—In such action the valid- ity and appropriateness of the final order imposing the
p.001591: penalty shall not be subject to review.
p.001591: (G) PAYMENT OF PENALTIES.—Except as otherwise pro- vided, penalties collected under this paragraph shall be paid
p.001591: to the Secretary (or other officer) imposing the pen- alty and shall be available without appropriation and
p.001591: until expended for the purpose of enforcing the provisions with respect to which the penalty was imposed.
p.001591: (3) ENFORCEMENT AUTHORITY RELATING TO GENETIC DIS- CRIMINATION.—
p.001591: (A) GENERAL RULE.—In the cases described in para- graph (1), notwithstanding the provisions of paragraph
p.001591: (2)(C), the succeeding subparagraphs of this paragraph shall apply with respect to an action under this
p.001591: subsection by the Secretary with respect to any failure of a health in- surance issuer in connection with a group
p.001591: health plan, to meet the requirements of subsection (a)(1)(F), (b)(3), (c), or
p.001591: (d) of section 2702 or section 2701 or 2702(b)(1) with re- spect to genetic information in connection with
p.001591: the plan.
p.001591: (B) AMOUNT.—
p.001591: (i) IN GENERAL.—The amount of the penalty im- posed under this paragraph shall be $100 for each day in the
p.001591: noncompliance period with respect to each par- ticipant or beneficiary to whom such failure relates.
p.001591: (ii) NONCOMPLIANCE PERIOD.—For purposes of this paragraph, the term ‘‘noncompliance period’’ means, with respect
p.001591: to any failure, the period—
p.001591: (I) beginning on the date such failure first oc- curs; and
p.001591: (II) ending on the date the failure is corrected.
p.001591: (C) MINIMUM PENALTIES WHERE FAILURE DISCOV- ERED.—Notwithstanding clauses (i) and (ii) of subpara-
p.001591: graph (D):
p.001591: (i) IN GENERAL.—In the case of 1 or more failures with respect to an individual—
p.001591: (I) which are not corrected before the date on which the plan receives a notice from the Sec- retary of such
p.001591: violation; and
...

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p.001601: January 30, 2020
p.001601: (i) a model act described in subsection (c)(1),
p.001601: (ii) a qualified high risk pool described in sub- section (c)(2), or
p.001601: (iii) a mechanism described in subsection (c)(3).
p.001601: (2) PERMISSIBLE FORMS OF MECHANISMS.—A private or public individual health insurance mechanism
p.001601: (such as a health insurance coverage pool or programs, mandatory group conversion policies, guaranteed
p.001601: issue of one or more plans of individual health insurance coverage, or open enrollment by one or more
p.001601: health insurance issuers), or combination of such mechanisms, that is designed to provide access to health bene-
p.001601: fits for individuals in the individual market in the State in ac- cordance with this section may constitute an
p.001601: acceptable alter- native mechanism.
p.001601: (b) APPLICATION OF ACCEPTABLE ALTERNATIVE MECHANISMS.—
p.001601: (1) PRESUMPTION.—
p.001601: (A) IN GENERAL.—Subject to the succeeding provisions of this subsection, a State is presumed to be implementing an
p.001601: acceptable alternative mechanism in accordance with this section as of July 1, 1997, if, by not later
p.001601: than April 1, 1997, the chief executive officer of a State—
p.001601: (i) notifies the Secretary that the State has en- acted or intends to enact (by not later than January
p.001601: 1, 1998, or July 1, 1998, in the case of a State de- scribed in subparagraph (B)(ii)) any necessary
p.001601: legisla- tion to provide for the implementation of a mechanism reasonably designed to be an acceptable
p.001601: alternative mechanism as of January 1, 1998, (or, in the case of a State described in subparagraph
p.001601: (B)(ii), July 1, 1998); and
p.001601: (ii) provides the Secretary with such information as the Secretary may require to review the mechanism and its
p.001601: implementation (or proposed implementation) under this subsection.
p.001601: (B) DELAY PERMITTED FOR CERTAIN STATES.—
p.001601: (i) EFFECT OF DELAY.—In the case of a State de- scribed in clause (ii) that provides notice under sub-
p.001601: paragraph (A)(i), for the presumption to continue on and after July 1, 1998, the chief executive officer
p.001601: of the State by April 1, 1998—
p.001601: (I) must notify the Secretary that the State has enacted any necessary legislation to provide for the
p.001601: implementation of a mechanism reason- ably designed to be an acceptable alternative mechanism as of
p.001601: July 1, 1998; and
p.001601: (II) must provide the Secretary with such in- formation as the Secretary may require to review the
p.001601: mechanism and its implementation (or pro- posed implementation) under this subsection.
p.001601: (ii) STATES DESCRIBED.—A State described in this clause is a State that has a legislature that does not
p.001601: meet within the 12-month period beginning on the date of enactment of this Act.
p.001601: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001601:
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p.001601:
p.001601: Sec. 2744 PUBLIC HEALTH SERVICE ACT 1602
p.001601: (C) CONTINUED APPLICATION.—In order for a mecha- nism to continue to be presumed to be an acceptable alter-
p.001601: native mechanism, the State shall provide the Secretary every 3 years with information described in subparagraph
p.001601: (A)(ii) or (B)(i)(II) (as the case may be).
p.001601: (2) NOTICE.—If the Secretary finds, after review of infor- mation provided under paragraph (1) and in
p.001601: consultation with the chief executive officer of the State and the insurance com- missioner or chief insurance
p.001601: regulatory official of the State, that such a mechanism is not an acceptable alternative mecha- nism or is not
p.001601: (or no longer) being implemented, the Sec- retary—
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p.001601: January 30, 2020
p.001601: (A) shall notify the State of—
p.001601: (i) such preliminary determination, and
p.001601: (ii) the consequences under paragraph (3) of a fail- ure to implement such a mechanism; and
p.001601: (B) shall permit the State a reasonable opportunity in which to modify the mechanism (or to adopt another mech- anism)
p.001601: in a manner so that may be an acceptable alter- native mechanism or to provide for implementation of such a
p.001601: mechanism.
p.001601: (3) FINAL DETERMINATION.—If, after providing notice and opportunity under paragraph (2), the Secretary
p.001601: finds that the mechanism is not an acceptable alternative mechanism or the State is not implementing such
p.001601: a mechanism, the Secretary shall notify the State that the State is no longer considered to be implementing an
p.001601: acceptable alternative mechanism and that the requirements of section 2741 shall apply to health in- surance
p.001601: coverage offered in the individual market in the State, effective as of a date specified in the notice.
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p.001663: to avoid the disruption of existing exchanges between participants of health information networks.
p.001663: (iv) APPLICATION BY FEDERAL AGENCIES.—Notwith- standing clauses (i), (ii), and (iii), Federal agencies may
p.001663: require the adoption of the trusted exchange framework and common agreement published under
p.001663: subparagraph (C) for health information exchanges contracting with or entering into agreements pursuant to
p.001663: subparagraph (E).
p.001663: (v) CONSIDERATION OF ONGOING WORK.—In car- rying out this paragraph, the Secretary shall ensure the
p.001663: consideration of activities carried out by public and private organizations related to exchange between health
p.001663: information exchanges to avoid duplication of efforts.
p.001663: (d) DETAIL OF FEDERAL EMPLOYEES.—
p.001663: (1) IN GENERAL.—Upon the request of the National Coordi- nator, the head of any Federal agency is authorized
p.001663: to detail, with or without reimbursement from the Office, any of the per- sonnel of such agency to the Office to
p.001663: assist it in carrying out its duties under this section.
p.001663: (2) EFFECT OF DETAIL.—Any detail of personnel under paragraph (1) shall—
p.001663: (A) not interrupt or otherwise affect the civil service status or privileges of the Federal employee; and
p.001663: (B) be in addition to any other staff of the Department employed by the National Coordinator.
p.001663: (3) ACCEPTANCE OF DETAILEES.—Notwithstanding any other provision of law, the Office may accept detailed
p.001663: personnel from other Federal agencies without regard to whether the agency described under paragraph (1) is
p.001663: reimbursed.
p.001663: (e) CHIEF PRIVACY OFFICER OF THE OFFICE OF THE NATIONAL COORDINATOR.—Not later than 12 months after the date
p.001663: of the en- actment of this title, the Secretary shall appoint a Chief Privacy Officer of the Office of
p.001663: the National Coordinator, whose duty it shall be to advise the National Coordinator on privacy, security,
p.001663: and data stewardship of electronic health information and to co- ordinate with other Federal agencies
p.001663: (and similar privacy officers in such agencies), with State and regional efforts, and with foreign countries with
p.001663: regard to the privacy, security, and data steward- ship of electronic individually identifiable health
p.001663: information.
p.001663: SEC. 3002. ø300jj–12¿ HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.
p.001663: (a) ESTABLISHMENT.—There is established a Health Informa- tion Technology Advisory Committee (referred to in this
p.001663: section as the ‘‘HIT Advisory Committee’’) to recommend to the National Co- ordinator, consistent with the
p.001663: implementation of the strategic plan described in section 3001(c)(3), policies, and, for purposes of adop-
p.001663: tion under section 3004, standards, implementation specifications, and certification criteria, relating to the
p.001663: implementation of a health information technology infrastructure, nationally and locally, that advances the
p.001663: electronic access, exchange, and use of health infor- mation. Such Committee shall serve to unify the
p.001663: roles of, and re- place, the HIT Policy Committee and the HIT Standards Com-
p.001663: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
p.000017:
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
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p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
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p.001705: January 30, 2020
p.001705: (A) WTC RESPONDERS STEERING COMMITTEE.—One Steering Committee, to be known as the WTC Responders Steering
p.001705: Committee, for the purpose of receiving input from affected stakeholders and facilitating the coordination of
p.001705: monitoring and treatment programs for the enrolled WTC responders under part 1 of subtitle B.
p.001705: (B) WTC SURVIVORS STEERING COMMITTEE.—One Steering Committee, to be known as the WTC Survivors
p.001705: Steering Committee, for the purpose of receiving input from affected stakeholders and facilitating the
p.001705: coordination of initial health evaluations, monitoring, and treatment programs for screening-eligible and
p.001705: certified-eligible WTC survivors under part 2 of subtitle B.
p.001705: (2) MEMBERSHIP.—
p.001705: (A) WTC RESPONDERS STEERING COMMITTEE.—
p.001705: (i) REPRESENTATION.—The WTC Responders Steering Committee shall include—
p.001705: (I) representatives of the Centers of Excel- lence providing services to WTC responders;
p.001705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001705:
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p.001705: Sec. 3303 PUBLIC HEALTH SERVICE ACT 1706
p.001705:
p.001705: (II) representatives of labor organizations rep- resenting firefighters, police, other New York City employees, and
p.001705: recovery and cleanup workers who responded to the September 11, 2001, terrorist at- tacks; and
p.001705: (III) 3 representatives of New York City, 1 of whom will be selected by the police commissioner of New
p.001705: York City, 1 by the health commissioner of New York City, and 1 by the mayor of New York City.
p.001705: (ii) INITIAL MEMBERSHIP.—The WTC Responders Steering Committee shall initially be composed of members
p.001705: of the WTC Monitoring and Treatment Pro- gram Steering Committee (as in existence on the day before the
p.001705: date of the enactment of this title).
p.001705: (B) WTC SURVIVORS STEERING COMMITTEE.—
p.001705: (i) REPRESENTATION.—The WTC Survivors Steer- ing Committee shall include representatives of—
p.001705: (I) the Centers of Excellence providing serv- ices to screening-eligible and certified-eligible WTC
p.001705: survivors;
p.001705: (II) the population of residents, students, and area and other workers affected by the September 11, 2001, terrorist
p.001705: attacks;
p.001705: (III) screening-eligible and certified-eligible survivors receiving initial health evaluations,
p.001705: monitoring, or treatment under part 2 of subtitle B and organizations advocating on their behalf; and
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p.001705: January 30, 2020
p.001705: (IV) New York City.
p.001705: (ii) INITIAL MEMBERSHIP.—The WTC Survivors Steering Committee shall initially be composed of
p.001705: members of the WTC Environmental Health Center Survivor Advisory Committee (as in existence on the day
p.001705: before the date of the enactment of this title).
p.001705: (C) ADDITIONAL APPOINTMENTS.—Each Steering Com- mittee may recommend, if approved by a majority of voting members
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p.001713: retired) who participated at least one day in the rescue and recovery effort at any of the former
p.001713: World Trade Center sites (including Ground Zero, Staten Is- land Landfill, and the New York City Chief
p.001713: Medical Examiner’s Office) for any time during the period be- ginning on September 11, 2001, and ending
p.001713: on July 31, 2002; or
p.001713: (ii)(I) is a surviving immediate family member of an individual who was a member of the Fire Depart-
p.001713: ment of New York City (whether fire or emergency personnel, active or retired) and was killed at the
p.001713: World Trade site on September 11, 2001; and
p.001713: (II) received any treatment for a WTC-related health condition described in section 3312(a)(1)(A)(ii)
p.001713: (relating to mental health conditions) on or before Sep- tember 1, 2008.
p.001713: (B) LAW ENFORCEMENT OFFICERS AND WTC RESCUE, RE- COVERY, AND CLEANUP WORKERS.—The individual—
p.001713: (i) worked or volunteered onsite in rescue, recov- ery, debris cleanup, or related support services
p.001713: in lower Manhattan (south of Canal St.), the Staten Is- land Landfill, or the barge loading piers, for
p.001713: at least 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001, for at
p.001713: least
p.001713: 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, or for at least
p.001713: 80 hours during the period beginning on Sep- tember 11, 2001, and ending on July 31, 2002;
p.001713: (ii)(I) was a member of the Police Department of New York City (whether active or retired) or a mem-
p.001713: ber of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or
p.001713: re- tired) who participated onsite in rescue, recovery, de- bris cleanup, or related services in lower
p.001713: Manhattan (south of Canal St.), including Ground Zero, the Stat- en Island Landfill, or the barge loading
p.001713: piers, for at least 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001;
p.001713: (II) participated onsite in rescue, recovery, debris cleanup, or related services at Ground Zero, the Staten
p.001713: Island Landfill, or the barge loading piers, for at least one day during the period beginning on September 11, 2001,
p.001713: and ending on July 31, 2002;
p.001713: (III) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal
p.001713: St.) for at least 24 hours during the period
p.001713: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001713:
p.001715: 1715
p.001715: PUBLIC HEALTH SERVICE ACT
p.001715: Sec. 3311
p.001715:
p.001715: beginning on September 11, 2001, and ending on Sep- tember 30, 2001; or
p.001715: (IV) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal
p.001715: St.) for at least 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002;
p.001715: (iii) was an employee of the Office of the Chief Medical Examiner of New York City involved in the
p.001715: examination and handling of human remains from the World Trade Center attacks, or other morgue worker who
p.001715: performed similar post-September 11 functions for such Office staff, during the period beginning on
p.001715: September 11, 2001, and ending on July 31, 2002;
p.001715: (iv) was a worker in the Port Authority Trans- Hudson Corporation Tunnel for at least 24 hours dur- ing the
p.001715: period beginning on February 1, 2002, and ending on July 1, 2002; or
p.001715: (v) was a vehicle-maintenance worker who was ex- posed to debris from the former World Trade Center while
p.001715: retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from
p.001715: the September 11, 2001, terrorist attacks during a duration and period described in subparagraph (A).
p.001715: (C) RESPONDERS TO THE SEPTEMBER 11 ATTACKS AT THE PENTAGON AND SHANKSVILLE, PENNSYLVANIA.—The indi-
p.001715: vidual—
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p.001715: January 30, 2020
p.001715: (i)(I) was a member of a fire or police department (whether fire or emergency personnel, active or re- tired),
p.001715: worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, dem- olition,
p.001715: debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of
p.001715: September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the
p.001715: cleanup of the site was concluded, as determined by the WTC Program Administrator; or
p.001715: (II) was a member of a fire or police department (whether fire or emergency personnel, active or re-
p.001715: tired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, dem-
p.001715: olition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related
p.001715: aircraft crash of September 11, 2001, during the pe- riod beginning on September 11, 2001, and ending
p.001715: on the date on which the cleanup of the site was con- cluded, as determined by the WTC Program
p.001715: Adminis- trator; and
p.001715: (ii) is determined by the WTC Program Adminis- trator to be at an increased risk of developing a WTC- related
p.001715: health condition as a result of exposure to air- borne toxins, other hazards, or adverse conditions re- sulting
p.001715: from the September 11, 2001, terrorist attacks, and meets such eligibility criteria related to such expo-
p.001715: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001715:
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p.001715:
p.001715: Sec. 3311 PUBLIC HEALTH SERVICE ACT 1716
p.001715:
p.001715: sures, as the WTC Program Administrator determines are appropriate, after consultation with the WTC Sci-
p.001715: entific/Technical Advisory Committee.
p.001715: (3) ENROLLMENT PROCESS.—
...

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p.000017: for Health Sta- tistics (hereinafter in this section referred to as the ‘‘Center’’) which shall be under the
p.000017: direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the
p.000017: Center, shall conduct and support statistical and epidemiological activities for the purpose of improving
p.000017: the effectiveness, efficiency, and quality of health services in the United States.
p.000017: (b) In carrying out subsection (a), the Secretary, acting through the Center—
p.000017: (1) shall collect statistics on—
p.000017: (A) the extent and nature of illness and disability of the population of the United States (or of any
p.000017: groupings of the people included in the population), including life ex- pectancy, the incidence of various
p.000017: acute and chronic ill- nesses, and infant and maternal morbidity and mortality,
p.000017: (B) the impact of illness and disability of the popu- lation on the economy of the United States and
p.000017: on other aspects of the well-being of its population (or of such groupings),
p.000017: (C) environmental, social, and other health hazards,
p.000017: (D) determinants of health,
p.000017: (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty
p.000017: and type of practice and the supply of services by hospitals, ex- tended care facilities, home health agencies,
p.000017: and other health institutions,
p.000017: (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types
p.000017: of practice of the health professionals providing such serv- ices, and (ii) services of hospitals,
p.000017: extended care facilities, home health agencies, and other institutions,
p.000017: (G) health care costs and financing, including the trends in health care prices and cost, the
p.000017: sources of pay-
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 3 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat. 2205). Title
p.000017: IX now applies to the matter with which former section 305 was concerned.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: Sec. 306 PUBLIC HEALTH SERVICE ACT 80
p.000017: ments for health care services, and Federal, State, and local governmental expenditures for health care
p.000017: services, and
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p.000017: January 30, 2020
p.000017: (H) family formation, growth, and dissolution;
p.000017: (2) shall undertake and support (by grant or contract) re- search, demonstrations, and evaluations respecting
...

p.000017: this subsection, a State plan for comprehensive State health planning must—
p.000017: (A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental
p.000017: agency, as the sole agency for administering or supervising the adminis- tration of the State’s health
p.000017: planning functions under the plan;
p.000017: (B) provide for the establishment of a State health plan- ning council, which shall include
p.000017: representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in
p.000017: such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the
p.000017: individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the
p.000017: representative of the hospitals or other health care facilities of such Department which are located in such
p.000017: State) and nongovernmental organi- zations and groups concerned with health (including represen- tation of the regional
p.000017: medical program or programs included in whole or in part within the State) and of consumers of health
p.000017: services, to advise such State agency in carrying out its func- tions under the plan, and a majority of the
p.000017: membership of such council shall consist of representatives of consumers of health services;
p.000017: (C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the
p.000017: Secretary, are designed to provide for comprehensive State planning for health services (both public and
p.000017: private and including home health care), including the facilities and persons required for the provision of
p.000017: such services, to meet the health needs of the people of the State and including environmental considerations as they
p.000017: relate to public health;
p.000017: (D) provide for encouraging cooperative efforts among gov- ernmental or nongovernmental agencies, organizations
p.000017: and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such
p.000017: agencies, organiza-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: 95 PUBLIC HEALTH SERVICE ACT Sec. 314
p.000017:
p.000017: tions, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and
p.000017: rehabilitation;
p.000017: (E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this
p.000017: subsection will be used to supplement and, to the extent practicable, to increase the level of funds that
p.000017: would otherwise be made available by the State for the purpose of comprehensive health planning and not to
p.000017: supplant such non-Federal funds;
p.000017: (F) 7 provide such methods of administration (including methods relating to the establishment and maintenance
...

p.000017: estimates by the Secretary of the sums the State will need in order to perform the planning under its
p.000017: approved State plan under this subsection, but with such adjustments as may be necessary to take account of
p.000017: previously made underpayments or overpayments. The ‘‘Federal share’’ for any State for purposes of this
p.000017: subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except
p.000017: that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per cen- tum, of
p.000017: such cost.
p.000017: Project Grants for Areawide Health Planning
p.000017: (b)(1)(A) The Secretary is authorized, during the period begin- ning July 1, 1966, and ending June 30, 1974, to
p.000017: make, with the ap- proval of the State agency administering or supervising the admin- istration of the State plan
p.000017: approved under subsection (a), project grants to any other public or nonprofit private agency or organiza- tion
p.000017: (but with appropriate representation of the interests of local government where the recipient of the grant is
p.000017: not a local govern- ment or combination thereof or an agency of such government or combination) to cover
p.000017: not to exceed 75 per centum of the costs of projects for developing (and from time to time revising)
p.000017: comprehen- sive regional, metropolitan area, or other local area plans for co- ordination of existing and
p.000017: planned health services, including the fa- cilities and persons required for provision of such services; and in-
p.000017: cluding the provision of such services through home health care;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 97 PUBLIC HEALTH SERVICE ACT Sec. 314
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p.000017: January 30, 2020
p.000017: except that in the case of project grants made in any State prior to July 1, 1968, approval of such
p.000017: State agency shall be required only if such State has such a State plan in effect at the time of such
p.000017: grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization
p.000017: to develop or revise health plans for an area unless the Secretary determines that such agency or organization
p.000017: provides means for appropriate representa- tion of the interests of the hospitals, other health care
p.000017: facilities, and practicing physicians serving such area, and the general pub- lic. For the purposes of
...

p.000103: (B) educating targeted populations and health care providers concerning immunizations in combination with
p.000103: one or more other interventions;
p.000103: (C) reducing out-of-pocket costs for families for vac- cines and their administration;
p.000103: (D) carrying out immunization-promoting strategies for participants or clients of public programs, including
p.000103: as- sessments of immunization status, referrals to health care
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000103:
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p.000103:
p.000103: Sec. 317A PUBLIC HEALTH SERVICE ACT 104
p.000103:
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p.000103: January 30, 2020
p.000103:
p.000103: providers, education, provision of on-site immunizations, or incentives for immunization;
p.000103: (E) providing for home visits that promote immuniza- tion through education, assessments of need, referrals,
p.000103: pro- vision of immunizations, or other services;
p.000103: (F) providing reminders or recalls for immunization providers;
p.000103: (G) conducting assessments of, and providing feedback to, immunization providers;
p.000103: (H) any combination of one or more interventions de- scribed in this paragraph; or
p.000103: (I) immunization information systems to allow all States to have electronic databases for
p.000103: immunization records.
p.000103: (4) CONSIDERATION.—In awarding grants under this sub- section, the Secretary shall consider any
p.000103: reviews or rec- ommendations of the Task Force on Community Preventive Services.
p.000103: (5) EVALUATION.—Not later than 3 years after the date on which a State receives a grant under this subsection, the
p.000103: State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage
p.000103: rates among high- risk populations within the State.
p.000103: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Affordable Health Choices
p.000103: Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program
p.000103: established under this subsection together with recommendations on whether to continue and expand such program.
p.000103: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection, such
p.000103: sums as may be necessary for each of fiscal years 2010 through 2014.
...

p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135:
p.000135: January 30, 2020
p.000135:
p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000135:
p.000135:
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p.000135:
p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
p.000135:
p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
p.000135: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000135: such Act;
p.000135:
p.000135:
p.000135:
p.000135:
...

p.000195: (2) SUBSEQUENT FISCAL YEARS.—There are authorized to be appropriated such sums as may be necessary to carry out this
p.000195: section for fiscal year 2008 and each subsequent fiscal year.
p.000195: SEC. 319F–1. ø247d–6a¿ AUTHORITY FOR USE OF CERTAIN PROCE- DURES REGARDING QUALIFIED COUNTERMEASURE
p.000195: RE- SEARCH AND DEVELOPMENT ACTIVITIES. 21
p.000195: (a) IN GENERAL.—
p.000195: (1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures
p.000195: under section 319F(e), the Secretary may conduct and support such activities in accordance with this
p.000195: section and, in consultation with the Director of the National Institutes of Health, as part of the program under
p.000195: section 446, if the activities concern qualified countermeasures.
p.000195: (2) DEFINITIONS.—In this section:
p.000195: (A) QUALIFIED COUNTERMEASURE.—The term ‘‘quali- fied countermeasure’’ means a drug (as that term is de-
p.000195: fined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological
p.000195: product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is
p.000195: defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the
p.000195: Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Home- land
p.000195: Security Act of 2002)—
p.000195: (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that
p.000195: cause an infectious disease) or toxin, chemical, radio- logical, or nuclear agent that may cause a
p.000195: public health emergency affecting national security;
p.000195: (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health
p.000195: consequences or death and may be caused by admin- istering a drug, biological product, or device that
p.000195: is used as described in this subparagraph; or
p.000195:
p.000195:
p.000195:
p.000195:
p.000195: January 30, 2020
p.000195: 21 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–1 and related
p.000195: provisions of law. Section 5 is included in the appendix to this compilation.
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000195:
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p.000195:
p.000195: Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 196
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p.000203: or replenished under this subsection, the Secretary completed a review addressing each item listed
p.000203: under this subsection in advance of such pro- curement or replenishment.
p.000203: (3) PROCEDURES.—The Secretary, in managing the stock- pile under paragraph (1), shall—
p.000203: (A) consult with the working group under section 319F(a) and the Public Health Emergency Medical
p.000203: Coun- termeasures Enterprise established under section 2811–1;
p.000203: (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and
p.000203: accounting, and for the physical security of the stockpile;
p.000203: (C) in consultation with Federal, State, and local offi- cials, take into consideration the timing and
p.000203: location of special events, and the availability, deployment, dis- pensing, and administration of
p.000203: countermeasures;
p.000203: (D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that
p.000203: emerging threats, advanced technologies, and new countermeasures are adequately considered and that the potential
p.000203: depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including
p.000203: through necessary replenishment;
p.000203: (E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with
p.000203: the Di- rector of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness
p.000203: and Response, the Secretary of Transportation, the Secretary of Home- land Security, the Secretary of
p.000203: Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial
p.000203: agencies; and the public and private health care infrastructure, as applicable, taking into ac- count the
p.000203: manufacturing capacity and other available sources of products and appropriate alternatives to sup-
p.000203: plies in the stockpile;
p.000203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000203: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 204
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p.000203: (F) deploy the stockpile as required by the Secretary of Homeland Security to respond to an actual or potential
p.000203: emergency;
p.000203: (G) deploy the stockpile at the discretion of the Sec- retary to respond to an actual or potential
p.000203: public health emergency or other situation in which deployment is nec- essary to protect the public health or
p.000203: safety;
p.000203: (H) ensure the adequate physical security of the stock-
p.000203: pile;
p.000203: (I) ensure that each countermeasure or product under
p.000203: consideration for procurement pursuant to this subsection receives the same consideration regardless of whether
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p.000207: (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and
p.000207: (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to
p.000207: affect national security.
p.000207: (B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER- MEASURES.—The Secretary shall on an ongoing basis—
p.000207: (i) assess the potential public health consequences for the United States population of exposure to agents identified
p.000207: under subparagraph (A)(ii); and
p.000207: (ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for
p.000207: which countermeasures are necessary to protect the public health.
p.000207: (C) NOTICE TO CONGRESS.—The Secretary and the Sec- retary of Homeland Security shall send to Congress, on an annual
p.000207: basis, all current material threat determinations and shall promptly notify the Committee on Health, Edu-
p.000207: cation, Labor, and Pensions and the Committee on Home- land Security and Governmental Affairs of the Senate and the
p.000207: Committee on Energy and Commerce and the Com- mittee on Homeland Security of the House of Representa-
p.000207: tives that a determination has been made pursuant to sub- paragraph (A) or (B).
p.000207: (D) ASSURING ACCESS TO THREAT INFORMATION.—In making the assessment and determination required under
p.000207: subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is
p.000207: en- titled under section 202 of the Homeland Security Act of 2002, including but not limited to
p.000207: information, regardless of its level of classification, relating to current and emerg- ing threats of chemical,
p.000207: biological, radiological, and nu- clear agents.
p.000207: (3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF COUNTERMEASURES.—
p.000207: (A) IN GENERAL.—The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongo- ing
p.000207: basis the availability and appropriateness of specific countermeasures to address specific threats
p.000207: identified under paragraph (2).
p.000207: (B) INFORMATION.—The Secretary shall institute a process for making publicly available the results of assess-
p.000207: ments under subparagraph (A) while withholding such in- formation as—
p.000207: (i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
p.000207: (ii) would otherwise be exempt from disclosure under section 552 of title 5, United States Code.
p.000207: (4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COM- MITMENT FOR RECOMMENDATION FOR PROCUREMENT.—
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p.000207: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 208
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p.000207: January 30, 2020
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p.000207: currently not developed or unavailable for procurement as a security countermeasure or is approved,
p.000207: licensed, or cleared only for alternative uses, such Secretaries may jointly submit to the President a
p.000207: proposal to—
p.000207: (i) issue a call for the development of such coun- termeasure; and
p.000207: (ii) make a commitment that, upon the first devel- opment of such countermeasure that meets the condi- tions for
p.000207: procurement under paragraph (5), the Secre- taries will, based in part on information obtained pur- suant to such call,
p.000207: and subject to the availability of ap- propriations, make available the special reserve fund as defined in
p.000207: subsection (h) for procurement of such countermeasure, as applicable.
p.000207: (B) COUNTERMEASURE SPECIFICATIONS.—The Home- land Security Secretary and the Secretary shall, to the ex- tent
p.000207: practicable, include in the proposal under subpara- graph (A)—
p.000207: (i) estimated quantity of purchase (in the form of number of doses or number of effective courses of
p.000207: treatments regardless of dosage form);
p.000207: (ii) necessary measures of minimum safety and ef- fectiveness;
p.000207: (iii) estimated price for each dose or effective course of treatment regardless of dosage form; and
p.000207: (iv) other information that may be necessary to encourage and facilitate research, development, and
p.000207: manufacture of the countermeasure or to provide spec- ifications for the countermeasure.
p.000207: (C) PRESIDENTIAL APPROVAL.—If the President ap- proves a proposal under subparagraph (A), the Homeland
p.000207: Security Secretary and the Secretary shall make known to persons who may respond to a call for the countermeasure
p.000207: involved—
p.000207: (i) the call for the countermeasure;
p.000207: (ii) specifications for the countermeasure under subparagraph (B); and
p.000207: (iii) the commitment described in subparagraph (A)(ii).
p.000207: (5) SECRETARY’S DETERMINATION OF COUNTERMEASURES AP- PROPRIATE FOR FUNDING FROM SPECIAL RESERVE FUND.—
p.000207: (A) IN GENERAL.—The Secretary, in accordance with the provisions of this paragraph, shall identify specific se-
p.000207: curity countermeasures that the Secretary determines, in consultation with the Homeland Security Secretary,
p.000207: to be appropriate for inclusion in the stockpile under subsection
p.000207: (a) pursuant to procurements made with amounts in the special reserve fund as defined in subsection (h)
p.000207: (referred to in this subsection individually as a ‘‘procurement under this subsection’’).
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p.000215: January 30, 2020
p.000215: sonable, allowable, and allocable direct cost of the con- tract involved.
p.000215: (8) INTERAGENCY COOPERATION.—
p.000215: (A) IN GENERAL.—In carrying out activities under this section, the Homeland Security Secretary and the Sec-
p.000215: retary are authorized, subject to subparagraph (B), to enter into interagency agreements and other
p.000215: collaborative undertakings with other agencies of the United States Government. Such agreements may allow
p.000215: other executive agencies to order qualified and security countermeasures under procurement contracts or
p.000215: other agreements estab- lished by the Secretary. Such ordering process (including transfers of appropriated
p.000215: funds between an agency and the Department of Health and Human Services as reimburse- ments for such orders
p.000215: for countermeasures) may be con- ducted under the authority of section 1535 of title 31, United States
p.000215: Code, except that all such orders shall be processed under the terms established under this sub- section
p.000215: for the procurement of countermeasures.
p.000215: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000215: the authorities provided by this section to the Home- land Security Secretary or to the Secretary.
p.000215: (d) DISCLOSURES.—No Federal agency may disclose under sec- tion 552 of title 5, United States Code any
p.000215: information identifying the location at which materials in the stockpile described in sub- section (a) are
p.000215: stored, or other information regarding the contents or deployment capability of the stockpile that could
p.000215: compromise na- tional security.
p.000215: (e) DEFINITION.—For purposes of subsection (a), the term ‘‘stockpile’’ includes—
p.000215: (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or
p.000215: (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or
p.000215: vendors agree to provide to such Secretary supplies described in subsection (a).
p.000215: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000215: (1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of carrying out subsection (a), there are authorized
p.000215: to be appro- priated $610,000,000 for each of fiscal years 2019 through 2023, to remain available until
p.000215: expended. Such authorization is in addition to amounts in the special reserve fund referred to in
p.000215: subsection (h).
p.000215: (2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of carrying out subsection (b), there are authorized to
p.000215: be appro- priated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of
p.000215: fiscal years 2003 through 2006.
p.000215: (g) SPECIAL RESERVE FUND.—
p.000215: (1) AUTHORIZATION OF APPROPRIATIONS.—In addition to amounts appropriated to the special reserve fund
p.000215: prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the
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p.000275: January 30, 2020
p.000275: (B) DISTRIBUTION OF GRANTS.—For fiscal year 2002 and each of the following fiscal years, the
p.000275: Secretary, in awarding grants under this section, shall ensure that the proportion of the amount made
p.000275: available under each of subsections (g), (h), and (i), relative to the total amount ap- propriated to carry out
p.000275: this section for that fiscal year, is equal to the proportion of the amount made available under that
p.000275: subsection for fiscal year 2001, relative to the total amount appropriated to carry out this section for fis-
p.000275: cal year 2001.
p.000275: (3) FUNDING REPORT.—The Secretary shall annually pre- pare and submit to the Committee on Health,
p.000275: Education, Labor, and Pensions of the Senate, and the Committee on En- ergy and Commerce of the House of
p.000275: Representatives, a report including, at a minimum—
p.000275: (A) the distribution of funds for carrying out this sec- tion that are provided to meet the health
p.000275: care needs of medically underserved populations, including the home- less, residents of public housing, and
p.000275: migratory and sea- sonal agricultural workers, and the appropriateness of the delivery systems involved in
p.000275: responding to the needs of the particular populations;
p.000275: (B) an assessment of the relative health care access needs of the targeted populations;
p.000275: (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban
p.000275: areas;
p.000275: (D) the distribution of awards and funding for estab- lishing new access points, and the number of new
p.000275: access points created;
p.000275: (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI;
p.000275: (F) the rationale for any substantial changes in the distribution of funds;
p.000275: (G) the rate of closures for health centers and access points;
p.000275: (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and
p.000275: (I) the number and reason for any waivers provided pursuant to subsection (q)(4).
p.000275: (4) RULE OF CONSTRUCTION WITH RESPECT TO RURAL HEALTH CLINICS.—
p.000275: (A) IN GENERAL.—Nothing in this section shall be con- strued to prevent a community health center from con-
p.000275: tracting with a Federally certified rural health clinic (as defined in section 1861(aa)(2) of the Social
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p.000291: Sec. 330I PUBLIC HEALTH SERVICE ACT 292
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p.000291: January 30, 2020
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p.000291: (ii) NATURE OF ENTITIES.—Each entity partici- pating in the telehealth network may be a nonprofit or
p.000291: for-profit entity.
p.000291: (iii) COMPOSITION OF NETWORK.—The telehealth network shall include at least 2 of the following enti- ties
p.000291: (at least 1 of which shall be a community-based health care provider):
p.000291: (I) Community or migrant health centers or other Federally qualified health centers.
p.000291: (II) Health care providers, including phar- macists, in private practice.
p.000291: (III) Entities operating clinics, including rural health clinics.
p.000291: (IV) Local health departments.
p.000291: (V) Nonprofit hospitals, including community access hospitals.
p.000291: (VI) Other publicly funded health or social service agencies.
p.000291: (VII) Long-term care providers.
p.000291: (VIII) Providers of health care services in the home.
p.000291: (IX) Providers of outpatient mental health services and entities operating outpatient mental health
p.000291: facilities.
p.000291: (X) Local or regional emergency health care providers.
p.000291: (XI) Institutions of higher education.
p.000291: (XII) Entities operating dental clinics.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—To be eligi- ble to receive a grant under subsection (d)(2), an
p.000291: entity shall be a nonprofit entity.
p.000291: (g) APPLICATIONS.—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation
p.000291: with the appropriate State office of rural health or another appropriate State entity, shall prepare and
p.000291: submit to the Secretary an application, at such time, in such manner, and containing such information as the
p.000291: Sec- retary may require, including—
p.000291: (1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000291: (2) a description of the manner in which the project funded under the grant will meet the health care needs of
p.000291: rural or other populations to be served through the project, or improve the access to services of, and the
p.000291: quality of the services re- ceived by, those populations;
p.000291: (3) evidence of local support for the project, and a descrip- tion of how the areas, communities, or populations to be
p.000291: served will be involved in the development and ongoing operations of the project;
p.000291: (4) a plan for sustaining the project after Federal support for the project has ended;
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p.000293: commitment of the entity to the project;
p.000293: (7) in the case of an application for a project involving a telehealth network, information demonstrating
p.000293: how the project will promote the integration of telehealth technologies into the operations of health care
p.000293: providers, to avoid redundancy, and improve access to and the quality of care; and
p.000293: (8) other such information as the Secretary determines to be appropriate.
p.000293: (h) TERMS; CONDITIONS; MAXIMUM AMOUNT OF ASSISTANCE.— The Secretary shall establish the terms and
p.000293: conditions of each grant program described in subsection (b) and the maximum amount of a grant to be
p.000293: awarded to an individual recipient for each fiscal year under this section. The Secretary shall publish, in a
p.000293: publication of the Health Resources and Services Administration, notice of the application requirements for
p.000293: each grant program de- scribed in subsection (b) for each fiscal year.
p.000293: (i) PREFERENCES.—
p.000293: (1) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for projects involving telehealth networks,
p.000293: the Secretary shall give preference to an eligible entity that meets at least 1 of the following requirements:
p.000293: (A) ORGANIZATION.—The eligible entity is a rural com- munity-based organization or another community-based or-
p.000293: ganization.
p.000293: (B) SERVICES.—The eligible entity proposes to use Fed- eral funds made available through such a grant to develop plans
p.000293: for, or to establish, telehealth networks that provide mental health, public health, long-term care, home care,
p.000293: preventive, case management services, or prenatal care for high-risk pregnancies.
p.000293: (C) COORDINATION.—The eligible entity demonstrates how the project to be carried out under the grant will
p.000293: be coordinated with other relevant federally funded projects in the areas, communities, and populations to
p.000293: be served through the grant.
p.000293: (D) NETWORK.—The eligible entity demonstrates that the project involves a telehealth network that includes
p.000293: an entity that—
p.000293: (i) provides clinical health care services, or edu- cational services for health care providers and for
p.000293: pa- tients or their families; and
p.000293: (ii) is—
p.000293: (I) a public library;
p.000293: (II) an institution of higher education; or
p.000293: (III) a local government entity.
p.000293: (E) CONNECTIVITY.—The eligible entity proposes a project that promotes local connectivity within areas, com-
p.000293: munities, or populations to be served through the project.
p.000293: (F) INTEGRATION.—The eligible entity demonstrates that health care information has been integrated into
p.000293: the project.
p.000293: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000293: (2) TELEHEALTH RESOURCE CENTERS.—In awarding grants under subsection (d)(2) for projects involving
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p.000347: community-based setting located in a health professional shortage area.
p.000347: (b) OBLIGATED SERVICE.—
p.000347: (1) IN GENERAL.—Any service described in subsection (a) that a participant provides may count towards
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p.000347: January 30, 2020
p.000347: figure so that it conforms to the proper size for figures that appear in a paragraph or below header.
p.000347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000349: PUBLIC HEALTH SERVICE ACT
p.000349: Sec. 339
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p.000349: pant’s completion of any obligated service requirements under the Scholarship Program or the Loan
p.000349: Repayment Program, subject to any limitation imposed under paragraph (2).
p.000349: (2) LIMITATION.—The Secretary may impose a limitation on the number of hours of service described in
p.000349: subsection (a) that a participant may credit towards completing obligated service requirements, provided
p.000349: that the limitation allows a member to credit service described in subsection (a) for not less than 50 percent
p.000349: of the total hours required to complete such obligated service requirements.
p.000349: (c) RULE OF CONSTRUCTION.—The authorization under sub- section (a) shall be notwithstanding any other provision
p.000349: of this sub- part or subpart II.
p.000349: Subpart IV—Home Health Services
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p.000349: HOME HEALTH SERVICES
p.000349: SEC. 339. ø255¿ (a)(1) For the purpose of encouraging the es- tablishment and initial operation of home
p.000349: health programs to pro- vide home health services in areas in which such services are inad- equate or not readily
p.000349: accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and non-
p.000349: profit private entities and loans to proprietary entities to meet the initial costs of establishing and operating
p.000349: such home health pro- grams. Such grants and loans may include funds to provide train- ing for
p.000349: paraprofessionals (including homemaker home health aides) to provide home health services.
p.000349: (2) In making grants and loans under this subsection, the Sec- retary shall—
p.000349: (A) consider the relative needs of the several States for home health services;
p.000349: (B) give preference to areas in which a high percentage of the population proposed to be served is composed of
p.000349: individuals who are elderly, medically indigent, or disabled; and
p.000349: (C) give special consideration to areas with inadequate means of transportation to obtain necessary health
p.000349: services. (3)(A) No loan may be made to a proprietary entity under this
p.000349: section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that—
p.000349: (i) at the time the application is made the entity is fiscally sound;
p.000349: (ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal
p.000349: lenders at the rate of interest prevailing in the area in which the entity is located; and
p.000349: (iii) during the period of the loan, such entity will remain fiscally sound.
p.000349: (B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on
p.000349: the date the loan is made with respect to the marketable obligations of the United States of comparable
p.000349: maturities, adjusted to provide for adminis- trative costs.
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000349: Sec. 339 PUBLIC HEALTH SERVICE ACT 350
p.000349:
p.000349: (4) Applications for grants and loans under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and loans under this subsection $5,000,000 for
p.000349: each of the fiscal years ending on September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986,
p.000349: and September 30, 1987.
p.000349: (b)(1) The Secretary may make grants to and enter into con- tracts with public and private entities to assist
p.000349: them in developing appropriate training programs for paraprofessionals (including homemaker home health
p.000349: aides) to provide home health services.
p.000349: (2) Any program established with a grant or contract under this subsection to train homemaker home health
p.000349: aides shall—
p.000349: (A) extend for at least forty hours, and consist of classroom instruction and at least twenty hours (in the aggregate)
p.000349: of su- pervised clinical instruction directed toward preparing stu- dents to deliver home health services;
p.000349: (B) be carried out under appropriate professional super- vision and be designed to train students to
p.000349: maintain or en- hance the personal care of an individual in his home in a man- ner which promotes the functional
p.000349: independence of the indi- vidual; and
p.000349: (C) include training in—
p.000349: (i) personal care services designed to assist an indi- vidual in the activities of daily living such as
p.000349: bathing, ex- ercising, personal grooming, and getting in and out of bed; and
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p.000349: (ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in
p.000349: providing good nutrition (by the purchasing and prepara- tion of food).
p.000349: (3) In making grants and entering into contracts under this subsection, special consideration shall be given
p.000349: to entities which es- tablish or will establish programs to provide training for persons fifty years of age
p.000349: and older who wish to become paraprofessionals (including homemaker home health aides) to provide home
p.000349: health services.
p.000349: (4) Applications for grants and contracts under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and con- tracts under this subsection $2,000,000 for each of the
p.000349: fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and
p.000349: September 30, 1987.
p.000349: (c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee
p.000349: on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
p.000349: (1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such
p.000349: subsections were in ef- fect prior to October 1, 1981);
p.000349: (2) the need to continue grants and loans under sub- sections (a) and (b) (as such subsections are in
p.000349: effect on the day after the date of enactment of the Orphan Drug Act); and
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000351: 351
p.000351: PUBLIC HEALTH SERVICE ACT
p.000351: Sec. 340
p.000351:
p.000351: (3) the extent to which standards have been applied to the training of personnel who provide home health services.
p.000351: (d) For purposes of this section, the term ‘‘home health serv- ices’’ has the meaning prescribed for
p.000351: the term by section 1861(m) of the Social Security Act.
p.000351: Subpart V—Healthy Communities Access Program
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p.000351: SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFI- CIENCY, AND COORDINATION OF SERVICES FOR THE
p.000351: UN- INSURED AND UNDERINSURED.
p.000351: (a) IN GENERAL.—The Secretary may award grants to eligible entities to assist in the development of integrated
p.000351: health care deliv- ery systems to serve communities of individuals who are uninsured and individuals who are
p.000351: underinsured—
p.000351: (1) to improve the efficiency of, and coordination among, the providers providing services through such
p.000351: systems;
p.000351: (2) to assist communities in developing programs targeted toward preventing and managing chronic diseases; and
p.000351: (3) to expand and enhance the services provided through such systems.
p.000351: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be an entity that—
p.000351: (1) represents a consortium—
p.000351: (A) whose principal purpose is to provide a broad range of coordinated health care services for a community
...

p.000385: (2) REQUIRED INCLUSION.—A network shall include the fol- lowing providers (unless such provider does not exist
p.000385: within the community, declines or refuses to participate, or places un- reasonable conditions on their participation):
p.000385: (A) A hospital that meets the criteria in section 1923(b)(1) of the Social Security Act; and
p.000385: (B) All Federally qualified health centers (as defined in section 1861(aa) of the Social Security Act located in
p.000385: the community.
p.000385: (3) PRIORITY.—In awarding grants, the Secretary shall give priority to networks that include—
p.000385: (A) the capability to provide the broadest range of services to low-income individuals;
p.000385: (B) the broadest range of providers that currently serve a high volume of low-income individuals; and
p.000385: (C) a county or municipal department of health.
p.000385: (c) APPLICATION.—
p.000385: (1) APPLICATION.—A network described in subsection (b) shall submit an application to the Secretary.
p.000385: (2) RENEWAL.—In subsequent years, based on the perform- ance of grantees, the Secretary may provide renewal grants to
p.000385: prior year grant recipients.
p.000385: (d) USE OF FUNDS.—
p.000385: (1) USE BY GRANTEES.—Grant funds may be used for the following activities:
p.000385: (A) Assist low-income individuals to—
p.000385: (i) access and appropriately use health services;
p.000385: (ii) enroll in health coverage programs; and
p.000385: (iii) obtain a regular primary care provider or a medical home.
p.000385: (B) Provide case management and care management.
p.000385: (C) Perform health outreach using neighborhood health workers or through other means.
p.000385: (D) Provide transportation.
p.000385: (E) Expand capacity, including through telehealth, after-hours services or urgent care.
p.000385: (F) Provide direct patient care services.
p.000385: (2) GRANT FUNDS TO HRSA GRANTEES.—The Secretary may limit the percent of grant funding that may be spent on direct
p.000385: care services provided by grantees of programs administered by the Health Resources and Services
p.000385: Administration or im- pose other requirements on such grantees deemed necessary.
p.000385:
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p.000385: January 30, 2020
p.000385: and section 340I, respectively. Such amendment probably should have included a reference to title III in
p.000385: the amendment instruction; however, such amendments were carried out to reflect the probable intent of
p.000385: Congress.
p.000385: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000387: PUBLIC HEALTH SERVICE ACT
p.000387: Sec. 351
p.000387:
p.000387: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000387: sums as may be necessary for each of fiscal years 2011 through 2015.
p.000387: øPart E (secs. 341–347) repealed by section 3405(a) of Public Law 106–310 (as amended by section 110(b)
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p.000413: methodologies for lab- oratory examinations and other procedures em- ployed, and the qualifications
p.000413: (educational back- ground, training, and experience) of the personnel directing and supervising the laboratory
p.000413: and per- forming the laboratory examinations and other procedures, and
p.000413: (III) that contains such other information as the Secretary may reasonably require to deter- mine
p.000413: compliance with this section, and
p.000413: (ii) the laboratory agrees to make records avail- able and submit reports to the Secretary as the Sec-
p.000413: retary may require.
p.000413: (B) CHANGES.—If a laboratory makes changes in the examinations and other procedures performed by it only
p.000413: with respect to examinations and procedures which are de- scribed in paragraph (3), the laboratory shall report
p.000413: such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory
p.000413: proposes to make changes in the examinations and procedures per- formed by it such that the laboratory
p.000413: will perform an ex- amination or procedure not described in paragraph (3), the laboratory shall report such change
p.000413: to the Secretary before the change takes effect.
p.000413: (C) EFFECT.—Subsections (f) and (g) shall not apply to a laboratory to which has been issued a certificate of waiv- er.
p.000413: (3) EXAMINATIONS AND PROCEDURES.—The examinations and procedures identified in paragraph (2) are
p.000413: laboratory ex- aminations and procedures that have been approved by the Food and Drug Administration for home
p.000413: use or that, as deter- mined by the Secretary, are simple laboratory examinations
p.000413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000413:
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p.000413: Sec. 353 PUBLIC HEALTH SERVICE ACT 414
p.000413:
p.000413: and procedures that have an insignificant risk of an erroneous result, including those that—
p.000413: (A) employ methodologies that are so simple and accu- rate as to render the likelihood of erroneous results by the user
p.000413: negligible, or
p.000413: (B) the Secretary has determined pose no unreason- able risk of harm to the patient if performed
p.000413: incorrectly.
p.000413: (4) DEFINITION.—As used in this section, the term ‘‘certifi- cate’’ includes a certificate of waiver issued
p.000413: under paragraph (2).
p.000413: (e) ACCREDITATION.—
p.000413: (1) IN GENERAL.—A laboratory may be accredited for pur- poses of obtaining a certificate if the laboratory—
p.000413: (A) meets the standards of an approved accreditation body, and
p.000413: (B) authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may des-
p.000413: ignate) such records or other information as the Secretary may require.
p.000413: (2) APPROVAL OF ACCREDITATION BODIES.—
p.000413: (A) IN GENERAL.—The Secretary may approve a pri- vate nonprofit organization to be an accreditation body for the
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p.000477: Sec. 393D PUBLIC HEALTH SERVICE ACT 478
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p.000477:
p.000477: (1) Oversee and support demonstration and research projects to be carried out by qualified
p.000477: organizations, institu- tions, or consortia of qualified organizations and institutions, specializing, or
p.000477: demonstrating expertise, in falls or fall preven- tion, in the following areas:
p.000477: (A) A multistate demonstration project assessing the utility of targeted fall risk screening and referral
p.000477: pro- grams.
p.000477: (B) Programs designed for community-dwelling older adults that utilize multicomponent fall intervention ap-
p.000477: proaches, including physical activity, medication assess- ment and reduction when possible, vision
p.000477: enhancement, and home modification strategies.
p.000477: (C) Programs that are targeted to new fall victims who are at a high risk for second falls and which are designed to
p.000477: maximize independence and quality of life for older adults, particularly those older adults with functional
p.000477: limi- tations.
p.000477: (D) Private sector and public-private partnerships to develop technologies to prevent falls among older
p.000477: adults and prevent or reduce injuries if falls occur.
p.000477: (2)(A) Award grants, contracts, or cooperative agreements to qualified organizations, institutions, or consortia
p.000477: of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or fall
p.000477: prevention, to design, implement, and evaluate fall prevention programs using proven intervention strategies in
p.000477: residential and institutional settings.
p.000477: (B) Award 1 or more grants, contracts, or cooperative agreements to 1 or more qualified organizations,
p.000477: institutions, or consortia of qualified organizations and institutions, special- izing, or demonstrating expertise, in
p.000477: falls or fall prevention, in order to carry out a multistate demonstration project to imple- ment and evaluate
p.000477: fall prevention programs using proven intervention strategies designed for single and multifamily res- idential
p.000477: settings with high concentrations of older adults, in- cluding—
p.000477: (i) identifying high-risk populations;
p.000477: (ii) evaluating residential facilities;
p.000477: (iii) conducting screening to identify high-risk individ- uals;
...

p.000479: report shall include a de- scription of such activities that were carried out with respect to interpersonal
p.000479: violence within families and among acquaintances and with respect to rural areas.
p.000479: SEC. 394A. ø280b–3¿ AUTHORIZATIONS OF APPROPRIATIONS.
p.000479: (a) IN GENERAL.—For the purpose of carrying out this part, there are authorized to be appropriated $50,000,000
p.000479: for fiscal year 1994, and 89 such sums as may be necessary for each of the fiscal years 1995 through
p.000479: 1998, and such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000479: (b) TRAUMATIC BRAIN INJURY.—To carry out sections 393B and 393C, there are authorized to be appropriated $11,750,000
p.000479: for each of fiscal years 2020 through 2024.
p.000479:
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p.000479: January 30, 2020
p.000479: 89 So in law. Section 1306 of Public Law 106–310 (114 Stat. 1143) attempts to strike ‘‘and’’, but the
p.000479: amendment cannot be executed because the instructions were to strike ‘‘and’’ after ‘‘1994’’. (The word
p.000479: ‘‘and’’ appears after ‘‘1994,’’, not ‘‘1994’’.)
p.000479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000479:
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p.000479: Sec. 395 PUBLIC HEALTH SERVICE ACT 480
p.000479:
p.000479: PART K—HEALTH CARE SERVICES IN THE HOME AND PUBLIC HEALTH PROGRAMS FOR DEMENTIA 90
p.000479: Subpart I—Grants for Demonstration Projects
p.000479: SEC. 395. ø280c¿ ESTABLISHMENT OF PROGRAM.
p.000479: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000479: Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of
p.000479: assisting grantees in carrying out demonstration projects—
p.000479: (1) to identify low-income individuals who can avoid insti- tutionalization or prolonged hospitalization if 91 skilled
p.000479: nursing care services, homemaker or home health aide services, or per- sonal care services are provided in the
p.000479: homes of the individ- uals;
p.000479: (2) to pay the costs of the provision of such services in the homes of such individuals; and
p.000479: (3) to coordinate the provision by public and private enti- ties of such services, and other long-term
p.000479: care services, in the homes of such individuals.
p.000479: (b) REQUIREMENT WITH RESPECT TO AGE OF RECIPIENTS OF
p.000479: SERVICES.—The Secretary may not make a grant under subsection
p.000479: (a) to a State unless the State agrees to ensure that—
p.000479: (1) not less than 25 percent of the grant is expended to provide services under such subsection to
p.000479: individuals who are not less than 65 years of age; and
p.000479: (2) of the portion of the grant reserved by the State for purposes of complying with paragraph (1), not less
p.000479: than 10 per- cent is expended to provide such services to individuals who are not less than 85 years of age.
p.000479: (c) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a grant under
p.000479: sub- section (a) for any item or service to the extent that payment has been made, or can reasonably be
p.000479: expected to be made, with respect to such item or service—
p.000479: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000479: health benefits program; or
p.000479: (2) by an entity that provides health services on a prepaid basis.
p.000479: SEC. 396. ø280c–1¿ LIMITATION ON DURATION OF GRANT AND RE- QUIREMENT OF MATCHING FUNDS.
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p.000485:
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p.000487: PUBLIC HEALTH SERVICE ACT
p.000487: Sec. 399
p.000487:
p.000487: (2) with respect to carrying out the purpose for which the grant is to be made, provide assurances of
p.000487: compliance satisfac- tory to the Secretary; and
p.000487: (3) otherwise be in such form, be made in such manner, and contain such information and agreements as the
p.000487: Secretary determines to be necessary to carry out this subpart.
p.000487: (c) EVALUATIONS AND REPORT BY SECRETARY.—The Secretary shall—
p.000487:
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p.000487: (1) provide for an evaluation of the activities for which an award is made under sections 398 or 398A; and
p.000487: (2) not later than 1 year after the completion of such eval- uations, submit to the Congress a report describing
p.000487: the find- ings made as a result of the evaluations.
p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
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p.000487: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000487: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000487: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000487: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
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p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: 489
p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
p.000489: (1) the ability of the entity involved to provide, either di- rectly or through linkages, a broad range of
p.000489: preventive and pri- mary health care services and related social, family support, and developmental services;
p.000489: (2) different combinations of professional and lay home visitors utilized within programs that are reflective of
p.000489: the iden- tified service needs and characteristics of target populations;
p.000489: (3) the extent to which the population to be targeted has limited access to health care, and related
p.000489: social, family sup- port, and developmental services; and
p.000489: (4) whether such grants are equitably distributed among urban and rural settings and whether entities
p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: Sec. 399 PUBLIC HEALTH SERVICE ACT 490
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p.000489: (A) the stated objective of the project to be operated with the grant, as determined after considering
p.000489: identified gaps in the current service delivery system; and
p.000489: (B) the nature of the needs of the family to be served, as determined at the initial assessment of the family that is
p.000489: conducted by the case manager, and through follow-up contacts by other providers of home visiting services.
p.000489: (4) FAMILY SERVICE PLAN.—A case manager, in consulta- tion with a team established in accordance with paragraph
p.000489: (5) for the family involved, shall develop a plan for the family fol- lowing the initial visit to the home of
p.000489: the family. Such plan shall reflect—
p.000489: (A) an assessment of the health and related social service needs of the family;
p.000489: (B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
p.000489: (C) the frequency with which such services are to be provided to the family;
p.000489: (D) ongoing revisions made as the needs of family members change; and
p.000489: (E) the continuing voluntary participation of the fam- ily in the plan.
p.000489: (5) HOME VISITING SERVICES TEAM.—The team to be con- sulted under paragraph (4) on behalf of a family shall
p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: 491
p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
p.000491: the entity will provide continuing training and sufficient support to the home visitors; and
p.000491: (3) such other information as the Secretary determines to be appropriate.
p.000491: (k) LIMITATION REGARDING ADMINISTRATIVE EXPENSES.—Not more than 10 percent of a grant under subsection
p.000491: (a) may be ex- pended for administrative expenses with respect to the grant. The costs of training
p.000491: individuals to serve in the project involved are not subject to the preceding sentence.
p.000491: (l) RESTRICTIONS ON USE OF GRANT.—To be eligible to receive a grant under this section, an entity must
p.000491: agree that the grant will not be expended—
p.000491: (1) to provide inpatient hospital services;
p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
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p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
p.000493:
p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
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p.000493: January 30, 2020
p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
p.000493: reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106 of Public Law 106–310 (114
p.000493: Stat. 1175) attempts to make various amendments to section 399D, but the amendments cannot be executed because section
p.000493: 399D was redesignated as section 399A by section 502(1) of such Public Law (114 Stat. 1115). (Section 399D
p.000493: now relates to technical assistance in operations of Statewide cancer registries.)
p.000493: Further, section 3106(m) of the Public Law (114 Stat. 1179) attempts to transfer section 399D to title V of this Act as
p.000493: a section 519, but this transfer has not been executed because it applied to section 399D ‘‘as amended by this
p.000493: section’’ (section 3106), and no amendments described in section 3106 have been made to section 399D.
p.000493: As a conforming amendment, section 3106(n) of the Public Law provided that title III of this Act ‘‘is amended by
p.000493: striking the heading for part L’’. This amendment has been executed, but for the convenience of the reader,
p.000493: a designation for a part L is shown above in brackets to indi- cate the probable intent of the Congress that section
p.000493: 399A is not included in part K of title III.
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p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
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p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
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p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
...

p.000545: (C) medically indicated deliveries before full term, and the risks of non-medically indicated deliveries before
p.000545: full term;
p.000545: (D) the importance of preconception and prenatal care, including—
p.000545: (i) smoking cessation;
p.000545: (ii) weight maintenance and good nutrition, in- cluding folic acid intake;
p.000545: (iii) the screening for and the treatment of infec- tions;
p.000545: (iv) screening for and treatment of substance use disorders;
p.000545: (v) screening for and treatment of maternal de- pression;
p.000545: (vi) maternal immunization; and
p.000545: (vii) stress management;
p.000545: (E) treatments and outcomes for premature infants, including late preterm infants; and
p.000545: (F) the informational needs of families during the stay of an infant in a neonatal intensive care unit.
p.000545: (2) programs to increase the availability, awareness, and use of pregnancy and post-term information
p.000545: services that pro- vide evidence-based, clinical information through counselors, community outreach efforts,
p.000545: electronic or telephonic commu- nication, or other appropriate means regarding causes associ- ated with
p.000545: prematurity, birth defects, or health risks to a post- term infant, as well as prevention of a future preterm birth;
p.000545: (3) programs to respond to the informational needs of fami- lies during the stay of an infant in a neonatal
p.000545: intensive care unit, during the transition of the infant to the home, and in the event of a newborn death;
p.000545: and
p.000545: (4) such other programs as the Secretary determines ap- propriate to achieve the purpose specified in
p.000545: subsection (a).
p.000545: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000545: $1,900,000 for each of fiscal years 2014 through 2018.
p.000545: SEC. 399R. ø280g–6¿ CHRONIC KIDNEY DISEASE INITIATIVES.
p.000545: (a) IN GENERAL.—The Secretary shall establish pilot projects
p.000545:
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p.000545: to—
p.000545:
p.000545: (1) increase public and medical community awareness (particularly of those who treat patients with diabetes
p.000545: and hy- pertension) regarding chronic kidney disease, focusing on pre- vention;
p.000545: (2) increase screening for chronic kidney disease, focusing on Medicare beneficiaries at risk of chronic kidney
p.000545: disease; and
p.000545: (3) enhance surveillance systems to better assess the prev- alence and incidence of chronic kidney disease.
p.000545: (b) SCOPE AND DURATION.—
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: discourage risky health behaviors;
p.000553: (3) to educate and provide outreach regarding enrollment in health insurance including the Children’s Health
p.000553: Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act and
p.000553: Medicaid under title XIX of such Act;
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: PUBLIC HEALTH SERVICE ACT
p.000555: Sec. 399V
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p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
p.000555: organizations in order to increase access to quality healthcare services and to eliminate duplicative care; or
p.000555: (5) to educate, guide, and provide home visitation services regarding maternal health and prenatal care.
p.000555: (c) APPLICATION.—Each eligible entity that desires to receive a grant under subsection (a) shall submit an
p.000555: application to the Sec- retary, at such time, in such manner, and accompanied by such in- formation as the Secretary
p.000555: may require.
p.000555: (d) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to applicants that—
p.000555: (1) propose to target geographic areas—
p.000555: (A) with a high percentage of residents who are eligi- ble for health insurance but are uninsured
p.000555: or under- insured;
p.000555: (B) with a high percentage of residents who suffer from chronic diseases; or
p.000555: (C) with a high infant mortality rate;
p.000555: (2) have experience in providing health or health-related social services to individuals who are underserved
p.000555: with respect to such services; and
p.000555: (3) have documented community activity and experience with community health workers.
p.000555: (e) COLLABORATION WITH ACADEMIC INSTITUTIONS AND THE ONE-STOP DELIVERY SYSTEM.—The Secretary shall
p.000555: encourage com- munity health worker programs receiving funds under this section to collaborate with academic
p.000555: institutions and one-stop delivery sys- tems under section 121(e) of the Workforce Innovation and Oppor- tunity Act.
p.000555: Nothing in this section shall be construed to require such collaboration.
p.000555: (f) EVIDENCE-BASED INTERVENTIONS.—The Secretary shall en- courage community health worker programs
p.000555: receiving funding under this section to implement a process or an outcome-based pay- ment system that rewards
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p.000555: Sec. 399V–1 PUBLIC HEALTH SERVICE ACT 556
p.000555: (k) DEFINITIONS.—In this section:
p.000555: (1) COMMUNITY HEALTH WORKER.—The term ‘‘community health worker’’ means an individual who promotes health
p.000555: or nutrition within the community in which the individual re- sides—
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p.000555: (A) by serving as a liaison between communities and healthcare agencies;
p.000555: (B) by providing guidance and social assistance to community residents;
p.000555: (C) by enhancing community residents’ ability to effec- tively communicate with healthcare providers;
p.000555: (D) by providing culturally and linguistically appro- priate health or nutrition education;
p.000555: (E) by advocating for individual and community health;
p.000555: (F) by providing referral and follow-up services or oth- erwise coordinating care; and
p.000555: (G) by proactively identifying and enrolling eligible in- dividuals in Federal, State, local, private or
p.000555: nonprofit health and human services programs.
p.000555: (2) COMMUNITY SETTING.—The term ‘‘community setting’’ means a home or a community organization located in
p.000555: the neighborhood in which a participant in the program under this section resides.
p.000555: (3) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private entity (including a
p.000555: State or public subdivision of a State, a public health department, a free health clinic, a hospital, or
p.000555: a Federally-qualified health center (as defined in section 1861(aa) of the Social Security Act)), or a
p.000555: consortium of any such entities.
p.000555: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ means a community
p.000555: iden- tified by a State—
p.000555: (A) that has a substantial number of individuals who are members of a medically underserved population, as de-
p.000555: fined by section 330(b)(3); and
p.000555: (B) a significant portion of which is a health profes- sional shortage area as designated under section 332.
p.000555: SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
p.000555: (a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
p.000555: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Agency for Healthcare Research and Quality,
p.000555: shall establish a Primary Care Extension Program.
p.000555: (2) PURPOSE.—The Primary Care Extension Program shall provide support and assistance to primary care providers
p.000555: to educate providers about preventive medicine, health pro- motion, chronic disease management, mental
p.000555: and behavioral health services (including substance abuse prevention and treatment services), and
p.000555: evidence-based and evidence-informed therapies and techniques, in order to enable providers to incor- porate such
p.000555: matters into their practice and to improve commu- nity health by working with community-based health connec-
p.000555: tors (referred to in this section as ‘‘Health Extension Agents’’).
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000557: PUBLIC HEALTH SERVICE ACT
p.000557: Sec. 399V–1
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p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
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p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
p.000557: (1) HUB ACTIVITIES.—Hubs established under a grant under subsection (b) shall—
p.000557: (A) submit to the Secretary a plan to coordinate func- tions with quality improvement organizations and area
p.000557: health education centers if such entities are members of the Hub not described in subsection (b)(2)(A);
p.000557: (B) contract with a county- or local-level entity that shall serve as the Primary Care Extension Agency
p.000557: to ad- minister the services described in paragraph (2);
p.000557: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000557: (C) organize and administer grant funds to county- or local-level Primary Care Extension Agencies that serve a
p.000557: catchment area, as determined by the State; and
p.000557: (D) organize State-wide or multistate networks of local-level Primary Care Extension Agencies to
p.000557: share and disseminate information and practices.
p.000557: (2) LOCAL PRIMARY CARE EXTENSION AGENCY ACTIVITIES.—
p.000557: (A) REQUIRED ACTIVITIES.—Primary Care Extension Agencies established by a Hub under paragraph (1) shall—
p.000557: (i) assist primary care providers to implement a patient-centered medical home to improve the accessi- bility,
p.000557: quality, and efficiency of primary care services, including health homes;
p.000557: (ii) develop and support primary care learning communities to enhance the dissemination of research findings for
p.000557: evidence-based practice, assess implemen- tation of practice improvement, share best practices, and involve
p.000557: community clinicians in the generation of new knowledge and identification of important ques- tions for
p.000557: research;
p.000557: (iii) participate in a national network of Primary Care Extension Hubs and propose how the Primary Care
p.000557: Extension Agency will share and disseminate les- sons learned and best practices; and
p.000557: (iv) develop a plan for financial sustainability in- volving State, local, and private contributions, to
p.000557: pro- vide for the reduction in Federal funds that is ex- pected after an initial 6-year period of program
p.000557: estab- lishment, infrastructure development, and planning.
p.000557: (B) DISCRETIONARY ACTIVITIES.—Primary Care Exten- sion Agencies established by a Hub under paragraph (1)
p.000557: may—
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p.000557: (i) provide technical assistance, training, and orga- nizational support for community health teams estab- lished
p.000557: under section 3602 of the Patient Protection and Affordable Care Act;
p.000557: (ii) collect data and provision of primary care pro- vider feedback from standardized measurements of
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p.000575: (c) APPLICATION.—An eligible entity seeking a grant under sub- section (a) shall submit to the Secretary an
p.000575: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000575:
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
...

p.000585: disorder or other develop-
p.000585:
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p.000585:
p.000585: January 30, 2020
p.000585: 108 Casing of heading for paragraph (1) so in law.
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000585: Sec. 399DD PUBLIC HEALTH SERVICE ACT 586
p.000585:
p.000585: mental disabilities and, as appropriate, on how such aver- age time varies across population subgroups;
p.000585: (G) information on the effectiveness and outcomes of interventions for individuals diagnosed with autism
p.000585: spec- trum disorder, including by severity level as practicable, and other developmental disabilities and
p.000585: how the age of the individual or other factors, such as demographic char- acteristics, may affect such
p.000585: effectiveness;
p.000585: (H) information on the effectiveness and outcomes of innovative and newly developed intervention strategies for
p.000585: individuals with autism spectrum disorder or other devel- opmental disabilities;
p.000585: (I) a description of the actions taken to implement and the progress made on implementation of the strategic plan
p.000585: developed by the Interagency Autism Coordinating Com- mittee under section 399CC(b); and
p.000585: (J) information on how States use home- and commu- nity-based services and other supports to ensure that indi-
p.000585: viduals with autism spectrum disorder and other develop- mental disabilities are living, working, and
p.000585: participating in their community.
p.000585: (b) REPORT ON THE HEALTH AND WELL-BEING OF INDIVIDUALS WITH AUTISM SPECTRUM DISORDER ACROSS THEIR
p.000585: LIFESPAN.—
p.000585: (1) IN GENERAL.—Not later than 2 years after the date of enactment of the Autism CARES Act of 2019,
p.000585: the Secretary shall prepare and submit, to the Committee on Health, Edu- cation, Labor, and Pensions of
p.000585: the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning
p.000585: the health and well-being of individuals with autism spectrum disorder.
p.000585: (2) CONTENTS.—The report submitted under paragraph (1) shall contain—
p.000585: (A) demographic factors associated with the health and well-being of individuals with autism spectrum dis-
p.000585: order;
p.000585: (B) an overview of policies and programs relevant to the health and well-being of individuals with autism spec-
p.000585: trum disorder, including an identification of existing Fed- eral laws, regulations, policies, research, and
p.000585: programs;
p.000585: (C) recommendations on establishing best practices guidelines to ensure interdisciplinary coordination between all
p.000585: relevant service providers receiving Federal funding;
p.000585: (D) comprehensive approaches to improving health outcomes and well-being for individuals with autism spec-
p.000585: trum disorder, including—
p.000585: (i) community-based behavioral supports and interventions;
p.000585: (ii) nutrition, recreational, and social activities;
p.000585: and
p.000585: (iii) personal safety services related to public safe-
p.000585:
...

p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
...

p.000865: limited to:
p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
...

p.000899: PART C—PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS
p.000899: SEC. 521. ø290cc–21¿ FORMULA GRANTS TO STATES.
p.000899: For the purpose of carrying out section 522, the Secretary, act- ing through the Director of the Center for Mental
p.000899: Health Services, shall for each of the fiscal years 2018 through 2022 make an allot- ment for each State in an
p.000899: amount determined in accordance with section 524. The Secretary shall make payments, as grants, each such
p.000899: fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.000899: year involved an application submitted by the State pursuant to section 529.
p.000899: SEC. 522. ø290cc–22¿ PURPOSE OF GRANTS.
p.000899: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless the State involved
p.000899: agrees that the pay- ments will be expended solely for making grants to political sub- divisions of the
p.000899: State, and to nonprofit private entities (including community-based veterans organizations and other
p.000899: community or- ganizations), for the purpose of providing the services specified in subsection (b) to
p.000899: individuals who—
p.000899: (1)(A) are suffering from serious mental illness; or
p.000899: (B) are suffering from serious mental illness and from a substance use disorder; and
p.000899: (2) are homeless or at imminent risk of becoming home- less.
p.000899: (b) SPECIFICATION OF SERVICES.—The services referred to in subsection (a) are—
p.000899: (1) outreach services;
p.000899: (2) screening and diagnostic treatment services;
p.000899: (3) habilitation and rehabilitation services;
p.000899: (4) community mental health services;
p.000899: (5) alcohol or drug treatment services;
p.000899: (6) staff training, including the training of individuals who work in shelters, mental health clinics, substance use
p.000899: disorder programs, and other sites where homeless individuals require services;
p.000899: (7) case management services, including—
p.000899: (A) preparing a plan for the provision of community mental health services to the eligible homeless
p.000899: individual involved, and reviewing such plan not less than once every 3 months;
p.000899: (B) providing assistance in obtaining and coordinating social and maintenance services for the eligible homeless
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000899:
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p.000901: 901
p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
...

p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
p.000901: benefits;
p.000901: (D) referring the eligible homeless individual for such other services as may be appropriate; and
p.000901: (E) providing representative payee services in accord- ance with section 1631(a)(2) of the Social Security
p.000901: Act if the eligible homeless individual is receiving aid under title XVI of such act and if the applicant is
p.000901: designated by the Secretary to provide such services;
p.000901: (8) supportive and supervisory services in residential set- tings;
p.000901: (9) referrals for primary health services, job training, edu- cational services, and relevant housing services;
p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
p.000901:
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p.000901: January 30, 2020
p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
p.000901: State involved agrees that, in making grants to entities pursuant to sub- section (a), the State will give special
p.000901: consideration to entities with a demonstrated effectiveness in serving homeless veterans.
p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
...

p.000909: program from which such hospital or outpatient facility receives support of any kind, with respect to the
p.000909: sus-
p.000909: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000909: Sec. 543 PUBLIC HEALTH SERVICE ACT 910
p.000909:
p.000909:
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p.000909: January 30, 2020
p.000909:
p.000909: pension or revocation of such other Federal support for such hospital or outpatient facility.
p.000909: (2) DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Under
p.000909: Secretary for Health, shall, to the maximum feasible extent consistent with their responsibilities under
p.000909: title 38, United States Code, pre- scribe regulations making applicable the regulations prescribed by the
p.000909: Secretary under paragraph (1) to the provision of hos- pital care, nursing home care, domiciliary care,
p.000909: and medical services under such title 38 to veterans suffering from sub- stance abuse. In prescribing
p.000909: and implementing regulations pursuant to this paragraph, the Secretary shall, from time to time, consult
p.000909: with the Secretary of Health and Human Serv- ices in order to achieve the maximum possible coordination
p.000909: of the regulations, and the implementation thereof, which they each prescribe.
p.000909: SEC. 543. ø290dd–2¿ CONFIDENTIALITY OF RECORDS.
p.000909: (a) REQUIREMENT.—Records of the identity, diagnosis, prog- nosis, or treatment of any patient which are
p.000909: maintained in connec- tion with the performance of any program or activity relating to substance abuse
p.000909: education, prevention, training, treatment, reha- bilitation, or research, which is conducted, regulated, or
p.000909: directly or indirectly assisted by any department or agency of the United States shall, except as provided
p.000909: in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly
p.000909: authorized under subsection (b).
p.000909: (b) PERMITTED DISCLOSURE.—
p.000909: (1) CONSENT.—The content of any record referred to in subsection (a) may be disclosed in accordance with
p.000909: the prior written consent of the patient with respect to whom such record is maintained, but only to
...

p.000911: health care to veterans; or
p.000911: (2) between such components and the Uniformed Services. The prohibitions of this section do not apply to the reporting
p.000911: under State law of incidents of suspected child abuse and neglect to the appropriate State or local
p.000911: authorities.
p.000911: (f) PENALTIES.—Any person who violates any provision of this section or any regulation issued pursuant to
p.000911: this section shall be fined in accordance with title 18, United States Code.
p.000911: (g) REGULATIONS.—Except as provided in subsection (h), the Secretary shall prescribe regulations to carry
p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
p.000911: to this subsection, the Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of
p.000911: Health and Human Services in order to achieve the maximum possible coordination of the regu- lations, and the
p.000911: implementation thereof, which they each prescribe.
p.000911: SEC. 543A. ø290dd–2a¿ PROMOTING ACCESS TO INFORMATION ON EVI- DENCE-BASED PROGRAMS AND PRACTICES.
p.000911: (a) IN GENERAL.—The Assistant Secretary shall, as appro- priate, improve access to reliable and valid
p.000911: information on evi- dence-based programs and practices, including information on the strength of evidence
p.000911: associated with such programs and practices, related to mental and substance use disorders for States, local com-
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
p.000931: provider involved to each child provided access to the system; and
p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
p.000933: (B) with respect to subparagraph (D) of such para- graph, to authorize the system of care to expend the grant
p.000933: under section 561(a) (or the non-Federal contributions made with respect to the grant) to provide
p.000933: legal services or any service with respect to which expenditures regard- ing the grant are prohibited under
p.000933: subsection (d)(1)(B).
p.000933: (f) RESTRICTIONS ON USE OF GRANT.—A funding agreement for a grant under section 561(a) is that the grant, and
p.000933: the non-Federal contributions made with respect to the grant, will not be ex- pended—
p.000933: (1) to purchase or improve real property (including the construction or renovation of facilities);
p.000933: (2) to provide for room and board in residential programs serving 10 or fewer children;
p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
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p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
p.000935: day treat- ment under paragraph (5) of such section, and foster care or group homes under paragraph (7)
p.000935: of such section; and
p.000935: (C) the development of individualized plans for pur- poses of section 563;
p.000935:
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p.000935: 16 So in law. See section 119 of Public Law 102–321 (106 Stat. 349). Probably should be a pe- riod.
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000935: Sec. 564 PUBLIC HEALTH SERVICE ACT 936
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p.000935: (3) recreational activities for children provided access to the system; and
...

p.000973: (3) Prior to the approval of the first project in a State during any fiscal year the State agency
p.000973: designated in accordance with sec- tion 604 shall give the Secretary written notification of the max- imum
p.000973: Federal share established pursuant to paragraph (2) for projects in such State to be approved by the Secretary
p.000973: during such fiscal year and the method for determining the actual Federal share to be paid with respect to
p.000973: such projects; and such maximum Federal share and such method of determination for projects in such State
p.000973: approved during such fiscal year shall not be changed after such approval.
p.000973: (4) Notwithstanding the provisions of paragraphs (2) and (3) of this subsection, the Federal share shall, at the option
p.000973: of the State agency, be equal to the per centum provided under such para- graphs plus an incentive per
p.000973: centum (which when combined with the per centum provided under such paragraphs shall not exceed
p.000973: 90 per centum) specified by the State agency in the case of (A) projects that will provide services
p.000973: primarily for persons in an area determined by the Secretary to be a rural or urban poverty area, and (B)
p.000973: projects that offer potential for reducing health care costs through shared services among health care
p.000973: facilities, through inter- facility cooperation, or through the construction or modernization of free-standing
p.000973: outpatient facilities.
p.000973: (c) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related
p.000973: facilities, such as laboratories, outpatient departments, nurses’ home facilities, extended care fa- cilities,
p.000973: facilities related to programs for home health services, self- care units, and central service facilities,
p.000973: operated in connection with hospitals, and also includes education or training facilities for health professions
p.000973: personnel operated as an integral part of a hos- pital, but does not include any hospital furnishing primarily domi-
p.000973: ciliary care.
p.000973: (d) The term ‘‘public health center’’ means a publicly owned fa- cility for the provision of public health
p.000973: services, including related publicly owned facilities such as laboratories, clinics, and adminis- trative offices
p.000973: operated in connection with such a facility.
p.000973: (e) The term ‘‘nonprofit’’ as applied to any facility means a fa- cility which is owned and operated by one or
p.000973: more nonprofit cor- porations or associations no part of the net earnings of which in- ures, or may
p.000973: lawfully inure, to the benefit of any private share- holder or individual.
p.000973: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000975: 975
p.000975: PUBLIC HEALTH SERVICE ACT
p.000975: Sec. 645
p.000975:
p.000975: (f) The term ‘‘outpatient facility’’ means a facility (located in or apart from a hospital) for the diagnosis or
p.000975: diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
p.000975: (1) which is operated in connection with a hospital, or
p.000975: (2) in which patient care is under the professional super- vision of persons licensed to practice medicine or
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p.001023: Sec. 747 PUBLIC HEALTH SERVICE ACT 1024
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p.001023: January 30, 2020
p.001023:
p.001023: (2) PREFERENCE IN MAKING AWARDS UNDER THIS SUB- SECTION.—In making awards of grants and
p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
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p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001025: 1025
p.001025: PUBLIC HEALTH SERVICE ACT
p.001025: Sec. 747A
p.001025:
p.001025: (1) IN GENERAL.—For purposes of carrying out this section (other than subsection (b)(1)(B)), there are authorized to be
p.001025: ap- propriated $125,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years
p.001025: 2011 through 2014.
p.001025: (2) TRAINING PROGRAMS.—Fifteen percent of the amount appropriated pursuant to paragraph (1) in each such
p.001025: fiscal year shall be allocated to the physician assistant training pro- grams described in subsection (a)(1)(F), which
p.001025: prepare students for practice in primary care.
p.001025: (3) INTEGRATING ACADEMIC ADMINISTRATIVE UNITS.—For purposes of carrying out subsection (b)(1)(B), there are
p.001025: author- ized to be appropriated $750,000 for each of fiscal years 2010 through 2014.
p.001025: SEC. 747A. ø293k–1¿ TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.
p.001025: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to enable such entities to provide new
p.001025: training opportuni- ties for direct care workers who are employed in long-term care set- tings such as nursing homes
p.001025: (as defined in section 1908(e)(1) of the Social Security Act (42 U.S.C. 1396g(e)(1)), assisted living facilities and
p.001025: skilled nursing facilities, intermediate care facilities for indi- viduals with mental retardation, home
p.001025: and community based set- tings, and any other setting the Secretary determines to be appro- priate.
p.001025: (b) ELIGIBILITY.—To be eligible to receive a grant under this section, an entity shall—
p.001025: (1) be an institution of higher education (as defined in sec- tion 102 of the Higher Education Act of 1965 (20 U.S.C.
p.001025: 1002)) that—
p.001025:
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p.001025: (A) is accredited by a nationally recognized accrediting agency or association listed under section 101(c) of
p.001025: the Higher Education Act of 1965 (20 U.S.C. 1001(c)); and
p.001025: (B) has established a public-private educational part- nership with a nursing home or skilled nursing
p.001025: facility, agency or entity providing home and community based services to individuals with disabilities, or
p.001025: other long-term care provider; and
p.001025: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001025: Sec- retary may require.
p.001025: (c) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant under this section
p.001025: to provide assistance to eligible individuals to offset the cost of tuition and required fees for enrollment in
p.001025: academic programs provided by such entity.
p.001025: (d) ELIGIBLE INDIVIDUAL.—
p.001025: (1) ELIGIBILITY.—To be eligible for assistance under this section, an individual shall be enrolled in
p.001025: courses provided by a grantee under this subsection and maintain satisfactory aca- demic progress in such courses.
p.001025: (2) CONDITION OF ASSISTANCE.—As a condition of receiving assistance under this section, an individual shall
p.001025: agree that, following completion of the assistance period, the individual will work in the field of geriatrics,
p.001025: disability services, long term
p.001025: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: or approved residency or advanced edu- cation programs in the practice of general, pediatric, or public
p.001027: health dentistry. Eligible entities may partner with schools of pub- lic health to permit the education of dental
p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
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p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
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p.001039: providing support (includ- ing residencies, traineeships, and fellowships) for geriatric training
p.001039: projects to train physicians, dentists and behavioral and mental health professionals who plan to teach
p.001039: geriatric medicine, geriatric behavioral or mental health, or geriatric dentistry.
p.001039: (2) REQUIREMENTS.—Each project for which a grant or con- tract is made under this subsection shall—
p.001039: (A) be staffed by full-time teaching physicians who have experience or training in geriatric medicine or
p.001039: geri- atric behavioral or mental health;
p.001039: (B) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching dentists
p.001039: who have experience or training in geriatric dentistry;
p.001039: (C) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching
p.001039: behav- ioral mental health professionals who have experience or training in geriatric behavioral or mental
p.001039: health;
p.001039: (D) be based in a graduate medical education program in internal medicine or family medicine or in a department of
p.001039: geriatrics or behavioral or mental health;
p.001039: (E) provide training in geriatrics and exposure to the physical and mental disabilities of elderly
p.001039: individuals through a variety of service rotations, such as geriatric consultation services, acute care
p.001039: services, dental services, geriatric behavioral or mental health units, day and home care programs, rehabilitation
p.001039: services, extended care facili- ties, geriatric ambulatory care and comprehensive evalua- tion units, and
p.001039: community care programs for elderly indi- viduals with intellectual disabilities; and
p.001039: (F) provide training in geriatrics through one or both of the training options described in subparagraphs (A)
p.001039: and
p.001039: (B) of paragraph (3).
p.001039: (3) TRAINING OPTIONS.—The training options referred to in subparagraph (F) of paragraph (2) shall be as follows:
p.001039: (A) A 1-year retraining program in geriatrics for—
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: (C) those that establish community-based allied health training programs that link academic centers to rural clin- ical
p.001045: settings;
p.001045: (D) those that provide career advancement training for practicing allied health professionals;
p.001045: (E) those that expand or establish clinical training sites for allied health professionals in medically
p.001045: under-
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p.001045: served or rural communities in order to increase the num- ber of individuals trained;
p.001045: (F) those that develop curriculum that will emphasize knowledge and practice in the areas of prevention and
p.001045: health promotion, geriatrics, long-term care, home health and hospice care, and ethics;
p.001045: (G) those that expand or establish interdisciplinary training programs that promote the effectiveness of
p.001045: allied health practitioners in geriatric assessment and the reha- bilitation of the elderly;
p.001045: (H) those that expand or establish demonstration cen- ters to emphasize innovative models to link allied health
p.001045: clinical practice, education, and research;
p.001045: (I) those that provide financial assistance (in the form of traineeships) to students who are participants in
p.001045: any such program; and
p.001045: (i) who plan to pursue a career in an allied health field that has a demonstrated personnel shortage; and
p.001045: (ii) who agree upon completion of the training pro- gram to practice in a medically underserved commu- nity;
p.001045: that shall be utilized to assist in the payment of all or part of the costs associated with tuition, fees and such
p.001045: other sti- pends as the Secretary may consider necessary; and
p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
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p.001081: coopera- tive program consisting of an entity that has received an award under subsection (a)(1) or
p.001081: (a)(2) of section 751 for the purpose of planning, developing, operating, and evaluating an area health
p.001081: education center program and one or more area health education centers, which carries out the required activi-
p.001081: ties described in section 751(c), satisfies the program require- ments in such section, has as one of
p.001081: its principal functions identifying and implementing strategies and activities that ad- dress health care workforce
p.001081: needs in its service area, in coordi- nation with the local workforce investment boards.
p.001081: (14) CLINICAL SOCIAL WORKER.—The term ‘‘clinical social worker’’ has the meaning given the term in section
p.001081: 1861(hh)(1) of the Social Security Act (42 U.S.C. 1395x(hh)(1)).
p.001081: (15) CULTURAL COMPETENCY.—The term ‘‘cultural com- petency’’ shall be defined by the Secretary in a
p.001081: manner con- sistent with section 1707(d)(3).
p.001081: (16) DIRECT CARE WORKER.—The term ‘‘direct care worker’’ has the meaning given that term in the 2010
p.001081: Standard Occu- pational Classifications of the Department of Labor for Home Health Aides [31–1011],
p.001081: Psychiatric Aides [31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
p.001081: (17) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001081: given that term in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
p.001081: (18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.— The term ‘‘frontier health professional shortage area’’
p.001081: means an area—
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p.001081: (A) with a population density less than 6 persons per square mile within the service area; and
p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: 1083
p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
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p.001085: reasonable as- surance that the program will meet the accreditation standards of such body or bodies
p.001085: prior to the beginning of the academic year following the normal graduation date of students of the first entering
p.001085: class in such a program.
p.001085: (7) NONPROFIT.—The term ‘‘nonprofit’’ as applied to any school, agency, organization, or institution means one
p.001085: which is a corporation or association, or is owned and operated by one or more corporations or
p.001085: associations, no part of the net earn- ings of which inures, or may lawfully inure, to the benefit of
p.001085: any private shareholder or individual.
p.001085: (8) STATE.—The term ‘‘State’’ means a State, the Common- wealth of Puerto Rico, the District of Columbia, the
p.001085: Common- wealth of the Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, or the Trust Territory
p.001085: of the Pacific Islands.
p.001085: (9) AMBULATORY SURGICAL CENTER.—The term ‘‘ambula- tory surgical center’’ has the meaning applicable to
p.001085: such term under title XVIII of the Social Security Act.
p.001085: (10) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001085: given such term under section 1861(aa)(4) of the Social Security Act.
p.001085: (11) HEALTH CARE FACILITY.—The term ‘‘health care facil- ity’’ means an Indian Health Service health
p.001085: center, a Native Hawaiian health center, a hospital, a Federally qualified health center, a rural
p.001085: health clinic, a nursing home, a home health agency, a hospice program, a public health clinic, a State
p.001085: or local department of public health, a skilled nursing fa- cility, an ambulatory surgical center, or any other
p.001085: facility des- ignated by the Secretary.
p.001085: (12) HOME HEALTH AGENCY.—The term ‘‘home health agen- cy’’ has the meaning given such term in section 1861(o) of the
p.001085: Social Security Act.
p.001085: (13) HOSPICE PROGRAM.—The term ‘‘hospice program’’ has the meaning given such term in section 1861(dd)(2)
p.001085: of the So- cial Security Act.
p.001085: (14) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given such term in section 1861(aa)(2) of
p.001085: the Social Security Act.
p.001085: (15) SKILLED NURSING FACILITY.—The term ‘‘skilled nurs- ing facility’’ has the meaning given
p.001085: such term in section 1819(a) of the Social Security Act.
p.001085: (16) ACCELERATED NURSING DEGREE PROGRAM.—The term ‘‘accelerated nursing degree program’’ means a program of edu-
p.001085: cation in professional nursing offered by an accredited school of nursing in which an individual holding
p.001085: a bachelors degree in another discipline receives a BSN or MSN degree in an ac- celerated time frame as
p.001085: determined by the accredited school of nursing.
p.001085: (17) BRIDGE OR DEGREE COMPLETION PROGRAM.—The term ‘‘bridge or degree completion program’’ means a program
p.001085: of
p.001085: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001085:
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p.001085: Sec. 802 PUBLIC HEALTH SERVICE ACT 1086
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
p.001091: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to paragraph
p.001091: (1) or (2).
p.001091: (1) GRANTS FOR CAREER LADDER PROGRAMS.—The Sec- retary may award grants to and enter into contracts
p.001091: with eligi- ble entities for programs—
p.001091: (A) to promote career advancement for nursing per- sonnel in a variety of training settings, cross
p.001091: training or specialty training among diverse population groups, and the advancement of individuals including to
p.001091: become profes- sional nurses, advanced education nurses, licensed prac- tical nurses, certified nurse
p.001091: assistants, and home health aides; and
p.001091: (B) to assist individuals in obtaining education and training required to enter the nursing profession
p.001091: and ad- vance within such profession, such as by providing career counseling and mentoring.
p.001091: (2) ENHANCING PATIENT CARE DELIVERY SYSTEMS.—
p.001091: (A) GRANTS.—The Secretary may award grants to eli- gible entities to improve the retention of nurses and
p.001091: en- hance patient care that is directly related to nursing ac- tivities by enhancing collaboration
p.001091: and communication among nurses and other health care professionals, and by promoting nurse involvement in
p.001091: the organizational and clinical decisionmaking processes of a health care facility.
p.001091: (B) PREFERENCE.—In making awards of grants under this paragraph, the Secretary shall give a preference to ap-
p.001091: plicants that have not previously received an award under this paragraph.
p.001091: (C) CONTINUATION OF AN AWARD.—The Secretary shall make continuation of any award under this paragraph be- yond the
p.001091: second year of such award contingent on the re- cipient of such award having demonstrated to the Sec-
p.001091: retary measurable and substantive improvement in nurse retention or patient care.
p.001091: (d) OTHER PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: to address other areas that are of high priority to nurse education, practice, and re- tention, as determined by the
p.001091: Secretary.
p.001091: (e) PREFERENCE.—For purposes of any amount of funds appro- priated to carry out this section for fiscal year 2003,
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p.001091: number of such grants and contracts and pro-
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001093: 1093
p.001093: PUBLIC HEALTH SERVICE ACT
p.001093: Sec. 831A
p.001093:
p.001093: vide an explanation of why each such grant or contract will meet the priority need of the nursing workforce.
p.001093: (g) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ includes a school of
p.001093: nursing, as defined in section 801(2),, 2 a health care facility, or a partnership of such a school and
p.001093: facility.
p.001093: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001093: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001093: SEC. 831A. ø296p–1¿ NURSE RETENTION GRANTS.
p.001093: (a) RETENTION PRIORITY AREAS.—The Secretary may award grants to, and enter into contracts with, eligible entities
p.001093: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to
p.001093: subsection (b) or (c).
p.001093: (b) GRANTS FOR CAREER LADDER PROGRAM.—The Secretary may award grants to, and enter into contracts with,
p.001093: eligible entities for programs—
p.001093: (1) to promote career advancement for individuals includ- ing licensed practical nurses, licensed
p.001093: vocational nurses, cer- tified nurse assistants, home health aides, diploma degree or associate degree
p.001093: nurses, to become baccalaureate prepared reg- istered nurses or advanced education nurses in order to meet the
p.001093: needs of the registered nurse workforce;
p.001093: (2) developing and implementing internships and residency programs in collaboration with an accredited school of
p.001093: nursing, as defined by section 801(2), to encourage mentoring and the development of specialties; or
p.001093: (3) to assist individuals in obtaining education and train- ing required to enter the nursing profession and
p.001093: advance with- in such profession.
p.001093: (c) ENHANCING PATIENT CARE DELIVERY SYSTEMS.—
p.001093: (1) GRANTS.—The Secretary may award grants to eligible entities to improve the retention of nurses and enhance
p.001093: patient care that is directly related to nursing activities by enhancing collaboration and communication among
p.001093: nurses and other health care professionals, and by promoting nurse involvement in the organizational and clinical
p.001093: decision-making processes of a health care facility.
p.001093: (2) PRIORITY.—In making awards of grants under this sub- section, the Secretary shall give preference to
p.001093: applicants that have not previously received an award under this subsection (or section 831(c) as such section
p.001093: existed on the day before the date of enactment of this section).
p.001093: (3) CONTINUATION OF AN AWARD.—The Secretary shall make continuation of any award under this subsection
p.001093: beyond the second year of such award contingent on the recipient of such award having demonstrated to
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p.001127: rate information or a copy thereof reported to a pa- tient safety organization shall not by reason of
p.001127: its re- porting be considered patient safety work product.
p.001127: (iii) Nothing in this part shall be construed to limit—
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p.001127: (I) the discovery of or admissibility of informa- tion described in this subparagraph in a criminal, civil, or
p.001127: administrative proceeding;
p.001127: (II) the reporting of information described in this subparagraph to a Federal, State, or local
p.001127: governmental agency for public health surveil- lance, investigation, or other public health pur- poses
p.001127: or health oversight purposes; or
p.001127: (III) a provider’s recordkeeping obligation with respect to information described in this sub- paragraph
p.001127: under Federal, State, or local law.
p.001127: (8) PROVIDER.—The term ‘‘provider’’ means—
p.001127: (A) an individual or entity licensed or otherwise au- thorized under State law to provide health care
p.001127: services, including—
p.001127: (i) a hospital, nursing facility, comprehensive out- patient rehabilitation facility, home health agency,
p.001127: hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care
p.001127: practitioner’s office, long term care facility, behavior health residential treatment facility, clinical
p.001127: labora- tory, or health center; or
p.001127: (ii) a physician, physician assistant, nurse practi- tioner, clinical nurse specialist, certified
p.001127: registered nurse anesthetist, certified nurse midwife, psycholo- gist, certified social worker, registered
p.001127: dietitian or nu- trition professional, physical or occupational therapist, pharmacist, or other individual
p.001127: health care practi- tioner; or
p.001127: (B) any other individual or entity specified in regula- tions promulgated by the Secretary.
p.001127: SEC. 922. ø299b–22¿ PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
p.001127: (a) PRIVILEGE.—Notwithstanding any other provision of Fed- eral, State, or local law, and subject to subsection
p.001127: (c), patient safety work product shall be privileged and shall not be—
p.001127: (1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order,
p.001127: including in a Federal, State, or local civil or administrative disciplinary proceeding against a
p.001127: provider;
p.001127: (2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative
p.001127: proceeding, including
p.001127: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: (1) by developing innovative uses of communications tech- nologies and the use of new communications technology;
p.001179: (2) by developing model curricula, such as advanced trau- ma life support, for training emergency medical
p.001179: services per- sonnel, including first responders, emergency medical techni- cians, emergency nurses and
p.001179: physicians, and paramedics—
p.001179: (A) in the assessment, stabilization, treatment, prepa- ration for transport, and resuscitation of seriously
p.001179: injured patients, with special attention to problems that arise dur- ing long transports and to methods of
p.001179: minimizing delays in transport to the appropriate facility; and
p.001179: (B) in the management of the operation of the emer- gency medical services system;
p.001179: (3) by making training for original certification, and con- tinuing education, in the provision and
p.001179: management of emer- gency medical services more accessible to emergency medical personnel in rural areas
p.001179: through telecommunications, home studies, providing teachers and training at locations accessible to such personnel,
p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
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p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: 1181
p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001219: the financial obligations of the health maintenance organization.
p.001219: (d) An organization that offers health benefits coverage shall not be considered as failing to meet the
p.001219: requirements of this sec- tion notwithstanding that it provides, with respect to coverage of- fered in
p.001219: connection with a group health plan in the small or large group market (as defined in section 2791(e)), an
p.001219: affiliation period consistent with the provisions of section 2701(g).
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001219:
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p.001219: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1220
p.001219:
p.001219: service. Such term includes a health service directly associated with an organ transplant only if such
p.001219: organ transplant was re- quired to be included in basic health services on April 15, 1985. For purposes of this
p.001219: paragraph, the term ‘‘home health services’’ means health services provided at a member’s home by health care
p.001219: per- sonnel, as prescribed or directed by the responsible physician or other authority designated by the
p.001219: health maintenance organization.
p.001219: (2) The term ‘‘supplemental health services’’ means any health service which is not included as a basic health service
p.001219: under para- graph (1) of this section. If a health service provided by a physician may also be provided under
p.001219: applicable State law by a dentist, op- tometrist, podiatrist, psychologist, or other health care
p.001219: personnel, a health maintenance organization may provide such service through an optometrist, dentist,
p.001219: podiatrist, psychologist, or other health care personnel (as the case may be) licensed to provide such service.
p.001219: (3) The term ‘‘member’’ when used in connection with a health maintenance organization means an individual who
p.001219: has entered into a contractual agreement, or on whose behalf a contractual ar- rangement has been entered into,
p.001219: with the organization under which the organization assumes the responsibility for the provision to such individual
p.001219: of basic health services and of such supple- mental health services as may be contracted for.
p.001219: (4) The term ‘‘medical group’’ means a partnership, association, or other group—
p.001219: (A) which is composed of health professionals licensed to practice medicine or osteopathy and of such
p.001219: other licensed health professionals (including dentists, optometrists, podia- trists, and psychologists) as
p.001219: are necessary for the provision of health services for which the group is responsible;
p.001219: (B) a majority of the members of which are licensed to practice medicine or osteopathy; and
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p.001257: Sec. 1623 PUBLIC HEALTH SERVICE ACT 1258
p.001257:
p.001257: (ii) which will only be used by the entity to provide the care required by clause (ii) of section 1621(b)(1)(K); and
p.001257: (B) will meet the obligation of the facility under clause (i) of section 1621(b)(1)(K).
p.001257: (2) The Secretary may waive the recovery rights of the United States under subsection (a)(2) with respect to a facility
p.001257: in any State if the Secretary determines, in accordance with regulations, that there is good cause for waiving
p.001257: such rights with respect to such fa- cility.
p.001257: (e) The right of recovery of the United States under subsection
p.001257: (a) shall not constitute a lien on any facility with respect to which funds have been paid under this title.
p.001257: CONTROL OF OPERATIONS
p.001257: SEC. 1623. ø300s–2¿ Except as otherwise specifically provided, nothing in this title shall be construed as conferring
p.001257: on any Federal officer, or employee the right to exercise any supervision or control over the administration,
p.001257: personnel, maintenance, or operation of any facility with respect to which any funds have been or may
p.001257: be expended under this title.
p.001257: DEFINITIONS
p.001257: SEC. 1624. ø300s–3¿ Except as provided in section 1642(e), for purposes of this title—
p.001257: (1) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related facilities,
p.001257: such as labora- tories, outpatient departments, nurses’ home facilities, ex- tended care facilities,
p.001257: facilities related to programs for home health services, self-care units, and central service facilities,
p.001257: operated in connection with hospitals, and also includes edu- cation or training facilities for health
p.001257: professonal 1 personnel operated as an integral part of a hospital, but does not include any hospital furnishing
p.001257: primarily domiciliary care.
p.001257: (2) The term ‘‘public health center’’ means a publicly owned facility for the provision of public
p.001257: health services, in- cluding related publicly owned facilities such as laboratories, clinics, and
p.001257: administrative offices operated in connection with such a facility.
p.001257: (3) The term ‘‘nonprofit’’ as applied to any facility means a facility which is owned and operated by
p.001257: one or more non- profit corporations or associations no part of the net earnings of which inures, or
p.001257: may lawfully inure, to the benefit of any private shareholder or individual.
p.001257: (4) The term ‘‘outpatient medical facility’’ means a medical facility (located in or apart from a hospital) for
p.001257: the diagnosis or diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
p.001257: (A) which is operated in connection with a hospital;
p.001257: (B) in which patient care is under the professional su- pervision of persons licensed to practice medicine or
p.001257: sur- gery in the State, or in the case of dental diagnosis or
p.001257:
p.001257:
p.001257:
p.001257: January 30, 2020
p.001257: 1 So in law. Probably should be ‘‘professional’’.
p.001257: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001257:
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p.001269: abuse programs, cancer screening, dietary and nutritional counseling, diabetes screening and edu- cation,
p.001269: intraocular pressure screening, and stress manage- ment).
p.001269: (b) The Secretary shall make a periodic survey of the needs, in- terest, attitudes, knowledge, and behavior of
p.001269: the American public regarding health and health care. The Secretary shall take into consideration the
p.001269: findings of such surveys and the findings of simi- lar surveys conducted by national and community health education
p.001269: organizations, and other organizations and agencies for formulating policy respecting health information and health
p.001269: promotion, preven- tive health services, and education in the appropriate use of health care.
p.001269:
p.001269:
p.001269:
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p.001269:
p.001269:
p.001269: January 30, 2020
p.001269:
p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
p.001269: appropriate settings representative of broad cross sections of the population, and include public edu- cation
p.001269: activities of voluntary health agencies, professional med- ical societies, and other private nonprofit health
p.001269: organizations,
p.001269: (B) focus on objectives that are measurable, and (C) emphasize
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001269:
p.001269:
p.001269:
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p.001269: Sec. 1704 PUBLIC HEALTH SERVICE ACT 1270
p.001269:
p.001269: the prevention or moderation of illness or accidents that ap- pear controllable through individual
p.001269: knowledge and behavior;
p.001269: (2) provide consultation and technical assistance to organi- zations that request help in planning, operating, or
p.001269: evaluating programs in such matters;
p.001269: (3) develop health information and health promotion mate- rials and teaching programs including (A) model
p.001269: curriculums for the training of educational and health professionals and paraprofessionals in health
p.001269: education by medical, dental, and nursing schools, schools of public health, and other institutions engaged in
...

p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
p.001343:
p.001343:
p.001343:
...

p.001347: source or sources of funding of such core services in the public and pri- vate sectors; or
p.001347: (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be
p.001347: provided and how the applicant will provide such services;
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001347:
p.001347:
p.001347:
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p.001347:
p.001347:
p.001349: 1349
p.001349: PUBLIC HEALTH SERVICE ACT
p.001349: Sec. 2006
p.001349:
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p.001349: January 30, 2020
p.001349: (6) a description of the manner in which adolescents need- ing services other than the services provided directly by
p.001349: the ap- plicant will be identified and how access and appropriate refer- ral to such other services (such as medicaid;
p.001349: licensed adoption agencies; maternity home services; public assistance; employ- ment services; child care
p.001349: services for adolescent parents; and other city, county, and State programs related to adolescent
p.001349: pregnancy) will be provided, including a description of a plan to coordinate such other services with
p.001349: the services supported under this title;
p.001349: (7) a description of the applicant’s capacity to continue services as Federal funds decrease and in the
p.001349: absence of Fed- eral assistance;
p.001349: (8) a description of the results expected from the provision of services, and the procedures to be used for evaluating
p.001349: those results;
p.001349: (9) a summary of the views of public agencies, providers of services, and the general public in the geographic
p.001349: area to be served, concerning the proposed use of funds provided for a demonstration project for services
p.001349: under this title and a de- scription of procedures used to obtain those views, and, in the case of applicants who
p.001349: propose to coordinate services adminis- tered by a State, the written comments of the appropriate State
p.001349: officials responsible for such services;
p.001349: (10) assurances that the applicant will have an ongoing quality assurance program;
p.001349: (11) assurances that, where appropriate, the applicant shall have a system for maintaining the
p.001349: confidentiality of pa- tient records in accordance with regulations promulgated by the Secretary;
p.001349: (12) assurances that the applicant will demonstrate its fi- nancial responsibility by the use of such
...

p.001373: policy, as determined by the Secretary.
p.001373: (4) For actual and projected pain and suffering and emo-
p.001373: tional distress from the vaccine-related injury, an award not to exceed $250,000.
p.001373: (b) VACCINES ADMINISTERED BEFORE THE EFFECTIVE DATE.— Compensation awarded under the Program to a
p.001373: petitioner under section 2111 for a vaccine-related injury or death associated with the administration of
p.001373: a vaccine before the effective date of this part 9 may include the compensation described in paragraphs (1)(A)
p.001373: and (2) of subsection (a) and may also include an amount, not to exceed a combined total of $30,000, for—
p.001373: (1) lost earnings (as provided in paragraph (3) of sub- section (a)),
p.001373: (2) pain and suffering (as provided in paragraph (4) of subsection (a)), and
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 9 Effective October 1, 1988.
p.001373:
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
p.001373:
p.001373:
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p.001373:
p.001373: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1374
p.001373:
p.001373: (3) reasonable attorneys’ fees and costs (as provided in subsection (e) 10.
p.001373: (c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and
p.001373: custodial care and service expenses under subsection (a)(1) shall be sufficient to en- able the compensated
p.001373: person to remain living at home.
p.001373: (d) TYPES OF COMPENSATION PROHIBITED.—Compensation awarded under the Program may not include the
p.001373: following:
p.001373: (1) Punitive or exemplary damages.
p.001373: (2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation
p.001373: for other than the health, education, or welfare of the person who suf- fered the vaccine-related injury with
p.001373: respect to which the com- pensation is paid.
p.001373: (e) ATTORNEYS’ FEES.—
p.001373: (1) In awarding compensation on a petition filed under sec- tion 2111 the special master or court shall also award as
p.001373: part of such compensation an amount to cover—
p.001373: (A) reasonable attorneys’ fees, and
p.001373: (B) other costs,
p.001373: incurred in any proceeding on such petition. If the judgment of a special master or court on such a petition
p.001373: does not award compensation, the special master or court may award an amount of compensation to
p.001373: cover petitioner’s reasonable attor- neys’ fees and other costs incurred in any proceeding on such
p.001373: petition if the special master or court determines that the peti- tion was brought in good faith and there was
p.001373: a reasonable basis for the claim for which the petition was brought.
p.001373: (2) If the petitioner, before the effective date of this part, 11 filed a civil action for damages for any
p.001373: vaccine-related injury or death for which compensation may be awarded under the Program, and petitioned under
p.001373: section 2111(a)(5) to have such action dismissed and to file a petition for compensation under the Program,
...

p.001415: (3) provide recommendations concerning future alterations with respect to this part.
p.001415: (c) DEFINITIONS.—For purposes of this part:
p.001415:
p.001415:
p.001415:
p.001415: January 30, 2020
p.001415: 7 Enacted June 10, 1993.
p.001415:
p.001415: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001415:
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p.001415:
p.001417: 1417
p.001417: PUBLIC HEALTH SERVICE ACT
p.001417: Sec. 2401
p.001417:
p.001417: (1) The term ‘‘AIDS activities’’ means AIDS research and other activities that relate to acquired immune
p.001417: deficiency syn- drome.
p.001417: (2) The term ‘‘AIDS research’’ means research with respect to acquired immune deficiency syndrome.
p.001417: (3) The term ‘‘Office’’ means the Office of AIDS Research.
p.001417: (4) The term ‘‘Plan’’ means the plan required in section 2353(a)(1).
p.001417: PART E—GENERAL PROVISIONS
p.001417: SEC. 2361. ø300cc–51¿ DEFINITION.
p.001417: For purposes of this title:
p.001417: (1) The term ‘‘infection’’, with respect to the etiologic agent for acquired immune deficiency syndrome, includes
p.001417: opportun- istic cancers and infectious diseases and any other conditions arising from infection with such
p.001417: etiologic agent.
p.001417: (2) The term ‘‘treatment’’, with respect to the etiologic agent for acquired immune deficiency syndrome,
p.001417: includes pri- mary and secondary prophylaxis.
p.001417: TITLE XXIV—HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001417: PART A—FORMULA GRANTS TO STATES FOR HOME AND COMMUNITY- BASED HEALTH SERVICES
p.001417: SEC. 2401. ø300dd¿ ESTABLISHMENT OF PROGRAM.
p.001417: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001417: fiscal years 1989 and 1990 make an allotment for each State in an amount deter- mined in accordance with
p.001417: section 2408. The Secretary shall make payments each such fiscal year to each State from the allotment for the
p.001417: State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant
p.001417: to section 2407.
p.001417: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001417: unless the State in- volved agrees to expend the payments only for the purpose of pro- viding services in accordance
p.001417: with section 2402.
p.001417: (c) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this part:
p.001417: (1) The term ‘‘eligible individual’’ means an individual in- fected with the etiologic agent for acquired
p.001417: immune deficiency syndrome who either is medically dependent or chronically de- pendent.
p.001417: (2) The term ‘‘medically dependent’’ means, with respect to an individual, that the individual has been certified by a
p.001417: physi- cian as—
p.001417: (A) requiring the routine use of appropriate medical services (which may include home intravenous drug
p.001417: ther- apy) to prevent or compensate for the individual’s serious deterioration, arising from infection
p.001417: with the etiologic agent for acquired immune deficiency syndrome, of phys- ical health or cognitive
p.001417: function, and
p.001417:
p.001417:
p.001417:
p.001417: January 30, 2020
p.001417: 1 See footnote at beginning of title XXIII.
p.001417:
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001417:
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p.001417:
p.001417: Sec. 2402 PUBLIC HEALTH SERVICE ACT 1418
p.001417:
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p.001417: January 30, 2020
p.001417:
p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
p.001417: (3) The term ‘‘chronically dependent’’ means, with respect to an individual, that the individual has been
p.001417: certified by a physician as—
p.001417: (A) being unable to perform, because of physical or cognitive impairment (without substantial assistance
p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
p.001417: (C) day treatment or other partial hospitalization serv- ices,
p.001417: (D) home intravenous drug therapy (including pre- scription drugs administered intravenously as part of such
p.001417: therapy), and
p.001417: (E) routine diagnostic tests administered in the indi- vidual’s home,
p.001417: furnished pursuant to such plan of care; but
p.001417: (3) does not include, except as specifically provided in paragraph (2)—
p.001417: (A) diagnostic tests,
p.001417: (B) inpatient hospital services,
p.001417: (C) nursing facility services, and
p.001417: (D) prescription drugs.
p.001417: SEC. 2402. ø300dd–1¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.001417: (a) REQUIRED USES OF FUNDS.—The Secretary may not make payments under section 2401(a) unless the State
p.001417: involved agrees that the State will—
p.001417: (1) provide for home and community-based health services for eligible individuals pursuant to written plans of care
p.001417: estab- lished by health care professionals for providing such services to such individuals;
p.001417: (2) provide for the identification, location, and provision of outreach to eligible individuals;
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001417:
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p.001419: PUBLIC HEALTH SERVICE ACT
p.001419: Sec. 2404
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p.001419: (3) provide for coordinating the provision of services under this part with the provision of similar or related
p.001419: services by public and private entities; and
p.001419: (4) give priority to the provision of outreach and home and community-based services to eligible individuals with
p.001419: low in- comes.
p.001419: (b) AUTHORITY FOR GRANTS AND CONTRACTS.—A State may make payment for services under subsection (a)
p.001419: through grants to public and nonprofit private entities and through contracts with public and private
p.001419: entities. In providing such financial assistance, a State shall give priority to public and nonprofit
p.001419: private entities that have demonstrated experience in delivering home and commu- nity-based health services to
p.001419: individuals infected with the etiologic agent for acquired immune deficiency syndrome.
p.001419: SEC. 2403. ø300dd–2¿ REQUIREMENT OF SUBMISSION OF DESCRIPTION OF INTENDED USES OF GRANT.
p.001419: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001419: (1) the State submits to the Secretary a description of the purposes for which the State intends to expend such
p.001419: payments for the fiscal year;
p.001419: (2) such description provides information relating to the services and activities to be provided,
p.001419: including a description of the manner in which such services and activities will be co- ordinated with any similar
p.001419: services and activities of public and private entities; and
p.001419: (3) such description includes information relating to (A) the process for determining which eligible
p.001419: individuals are medically dependent or chronically dependent and (B) the proc- ess for establishing written plans
p.001419: of care for the provision of home and community-based health services under this part.
p.001419: SEC. 2404. ø300dd–3¿ RESTRICTIONS ON USE OF GRANT.
p.001419: (a) IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year to a
p.001419: State unless the State agrees that the payments will not be expended—
p.001419: (1) to provide for items or services described in section 2401(d)(3);
p.001419: (2) to make cash payments to intended recipients of serv- ices;
p.001419: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001419: or to purchase major medical equipment; or
p.001419: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001419: of Federal funds.
p.001419: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2401(a) for a fiscal
p.001419: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments made to the
p.001419: State under such sec- tion for administrative expenses with respect to carrying out the purpose of this part.
p.001419: (c) LIMITATION ON TOTAL PAYMENTS.—
p.001419: (1) Before March 1, 1989, for fiscal year 1989 and before September 1, 1989, for fiscal year 1990, the
p.001419: Secretary shall de-
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001419: Sec. 2405 PUBLIC HEALTH SERVICE ACT 1420
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p.001419: January 30, 2020
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p.001419: termine and publish the national average monthly payments, for extended care services under part A of title
p.001419: XVIII of the So- cial Security Act, for each resident of a skilled nursing facility the Secretary estimates will be
p.001419: paid in the fiscal year.
p.001419: (2) The Secretary may not make payments under section 2401(a) for a fiscal year to a State to the extent that
p.001419: the aver- age monthly payments for eligible individuals provided home and community-based health services
p.001419: under this part in the State exceeds 65 percent of the national average monthly pay- ments determined and
p.001419: published for the fiscal year under paragraph (1).
p.001419: SEC. 2405. ø300dd–4¿ REQUIREMENT OF REPORTS AND AUDITS BY STATES.
p.001419: (a) REPORTS.—
p.001419: (1) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State
p.001419: involved agrees to prepare and submit to the Secretary, by not later than January 1 following the fiscal year, an
p.001419: annual report in such form and containing such information as the Secretary determines (after consultation with the
p.001419: States and the Comptroller General of the United States) to be necessary for—
p.001419: (A) securing a record and a description of the purposes for which payments received by the State pursuant to sec- tion
p.001419: 2401(a) were expended and of the recipients of such payments;
p.001419: (B) determining whether the payments were expended in accordance with the purpose of this part; and
p.001419: (C) determining the percentage of payments received pursuant to section 2401(a) that were expended by the
p.001419: State for administrative expenses during the fiscal year in- volved.
p.001419: (2) Each report by a State under paragraph (1) for a fiscal year also shall include—
p.001419: (A) information on the number and type of eligible in- dividuals provided home and community-based health
p.001419: services by the State under this part for the fiscal year;
p.001419: (B) information on the types of home and community- based health services so provided;
p.001419: (C) information on the average monthly costs of such services and a comparison of such costs with costs
p.001419: of pro- viding services in hospitals, nursing facilities, and similar institutions; and
p.001419: (D) such other information as the Secretary may re- quire to provide for an evaluation of the program
p.001419: under this part and its cost-effectiveness.
p.001419: (b) AUDITS.—
p.001419: (1) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State involved
p.001419: agrees to es- tablish such fiscal control and fund accounting procedures as may be necessary to ensure the
p.001419: proper disbursal of, and ac- counting for, amounts received by the State under such section.
p.001419: (2) The Secretary may not make payments under section 2401(a) for a fiscal year unless the State involved
p.001419: agrees that—
p.001419: (A) the State will provide for—
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001421: Sec. 2406
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p.001421: (i) a financial and compliance audit of such pay- ments; or
p.001421: (ii) a single financial and compliance audit of each entity administering such payments;
p.001421: (B) the audit will be performed biennially and will cover expenditures in each fiscal year; and
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p.001421: fi- nancial statements of an audited entity present fairly the fi- nancial position, and the results of
p.001421: financial operations, of the entity in accordance with generally accepted accounting prin- ciples, and whether
p.001421: the entity has complied with laws and reg- ulations that may have a material effect upon the financial
p.001421: statements.
p.001421: (c) AVAILABILITY TO PUBLIC.—The Secretary may not make payments under section 2401(a) unless the State involved
p.001421: agrees to make copies of the reports and audits described in this section available for public inspection.
p.001421: (d) EVALUATIONS BY COMPTROLLER GENERAL.—The Comp- troller General of the United States shall, from time to
p.001421: time, evalu- ate the expenditures by the States of payments under section 2401(a) in order to assure that
p.001421: expenditures are consistent with the provisions of this part.
p.001421: SEC. 2406. ø300dd–5¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001421: (a) 2 IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year unless
p.001421: the State involved agrees that—
p.001421: (1) the legislature of the State will conduct public hearings on the proposed use and distribution of the payments to
p.001421: be re- ceived from the allotments for each such fiscal year;
p.001421: (2)(A) the State will, to the maximum extent practicable, ensure that services provided to an individual
p.001421: pursuant to the program involved will be provided without regard to the ability of the individual to pay for such
p.001421: services and without regard to the current or past health condition of the individual;
p.001421: (B) if any charges are imposed for the provision of home and community-based health services for which
p.001421: assistance is provided under this part, such charges (i) will be pursuant to a public schedule of charges,
p.001421: (ii) will not be imposed on any eli- gible individual with an income that does not exceed 100 per- cent of
p.001421: the official poverty line, and (iii) for an eligible indi- vidual with an income that exceeds 100
p.001421: percent of the official
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p.001421: 2 So in law. This section does not contain a subsection (b).
p.001421: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001421: Sec. 2407 PUBLIC HEALTH SERVICE ACT 1422
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p.001421: January 30, 2020
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p.001421: poverty line, will be adjusted to reflect the income of the indi- vidual;
p.001421: (3) the State will provide for periodic independent peer re- view to assess the quality and appropriateness of
p.001421: home and community-based health services provided by entities that re- ceive funds from the State pursuant to
p.001421: section 2401(a);
p.001421: (4) the State will permit and cooperate with Federal inves- tigations undertaken under section 2409(e);
p.001421: (5) the State will maintain State expenditures for home and community-based health services for
p.001421: individuals infected with the etiologic agent for acquired immune deficiency syn- drome at a level equal
p.001421: to not less than the average level of such expenditures maintained by the State for the 2-year pe- riod
p.001421: preceding the fiscal year for which the State is applying to receive payments; and
p.001421: (6) the State will not make payments from allotments made under section 2401(a) for any item or service
p.001421: to the ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect
p.001421: to that item or service (i) under any State compensation program, under an insurance policy, under any
p.001421: Federal or State health benefits program, or
p.001421: (ii) by an entity that provides health services on a prepaid basis.
p.001421: SEC. 2407. ø300dd–6¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001421: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001421: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001421: accordance with sec- tions 2401 through 2406;
p.001421: (2) the agreements are made through certification from the chief executive officer of the State;
p.001421: (3) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001421: Secretary;
p.001421: (4) the application contains the description of intended ex- penditures required in section 2403; and
p.001421: (5) the application otherwise is in such form, is made in such manner, and contains such agreements,
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p.001459:
p.001459: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001459: this title.
p.001459: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing the chief elected official of an eligible area that a grant
p.001459: under section 2601 is being made for the area for a grant year, the Secretary shall inform the
p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
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p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
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p.001473: if the Secretary determines that, within the State—
p.001473: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001473: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
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p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: Sec. 2612 PUBLIC HEALTH SERVICE ACT 1474
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p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
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p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001477:
p.001477: (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for
p.001477: adult and pediatric HIV-related care demonstration projects; and then
p.001477: (2) to any other existing HIV care consortia.
p.001477: (f) ALLOCATION OF FUNDS; TREATMENT AS SUPPORT SERVICES.— For purposes of the requirement of section 2612(b)(1),
p.001477: expenditures of grants under section 2611 for or through consortia under this section are deemed to be
p.001477: support services, not core medical serv- ices. The preceding sentence may not be construed as having any
p.001477: legal effect on the provisions of subsection (a) that relate to author- ized expenditures of the grant.
p.001477: SEC. 2614. ø300ff–24¿ GRANTS FOR HOME- AND COMMUNITY-BASED CARE.
p.001477: (a) USES.—A State may use amounts provided under a grant awarded under section 2611 to make grants
p.001477: under section 2612(b)(3)(J) to entities to—
p.001477: (1) provide home- and community-based health services for individuals with HIV/AIDS pursuant to written plans of
p.001477: care prepared by a case management team, that shall include ap- propriate health care professionals, in such
p.001477: State for providing such services to such individuals;
p.001477: (2) provide outreach services to individuals with HIV/ AIDS, including those individuals in rural areas;
p.001477: and
p.001477: (3) provide for the coordination of the provision of services under this section with the provision of
p.001477: HIV-related health services, including specialty care and vaccinations for hepatitis co-infection, provided by public
p.001477: and private entities.
p.001477: (b) PRIORITY.—In awarding grants under subsection (a), a State shall give priority to entities that
p.001477: provide assurances to the State that—
p.001477: (1) such entities will participate in HIV care consortia if such consortia exist within the State; and
p.001477: (2) such entities will utilize amounts provided under such grants for the provision of home- and
p.001477: community-based serv- ices to low-income individuals with HIV/AIDS.
p.001477: (c) DEFINITION.—As used in section 2611, the term ‘‘home- and community-based health services’’—
p.001477: (1) means, with respect to an individual with HIV/AIDS, skilled health services furnished to the
p.001477: individual in the indi- vidual’s home pursuant to a written plan of care established by a case management team, that
p.001477: shall include appropriate health care professionals, for the provision of such services and items described in
p.001477: paragraph (2);
p.001477: (2) includes—
p.001477: (A) durable medical equipment;
p.001477: (B) home health aide services and personal care serv- ices furnished in the home of the individual;
p.001477: (C) day treatment or other partial hospitalization serv- ices;
p.001477: (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such
p.001477: therapy);
p.001477: (E) routine diagnostic testing administered in the home of the individual; and
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001479: 1479
p.001479: PUBLIC HEALTH SERVICE ACT
p.001479: Sec. 2616
p.001479:
p.001479: (F) appropriate mental health, developmental, and re- habilitation services; and
p.001479: (3) does not include—
p.001479: (A) inpatient hospital services; and
p.001479: (B) nursing home and other long term care facilities.
p.001479: SEC. 2615. ø300ff–25¿ CONTINUUM OF HEALTH INSURANCE COVERAGE.
p.001479: (a) IN GENERAL.—A State may use amounts received under a grant awarded under section 2611 to establish a
p.001479: program of finan- cial assistance under section 2612(b)(3)(F) to assist eligible low-in- come individuals with
p.001479: HIV/AIDS in—
p.001479: (1) maintaining a continuity of health insurance; or
p.001479: (2) receiving medical benefits under a health insurance program, including risk-pools.
p.001479: (b) LIMITATIONS.—Assistance shall not be utilized under sub- section (a)—
p.001479: (1) to pay any costs associated with the creation, capital- ization, or administration of a liability
p.001479: risk pool (other than those costs paid on behalf of individuals as part of premium contributions to
p.001479: existing liability risk pools); and
p.001479: (2) to pay any amount expended by a State under title XIX of the Social Security Act.
p.001479: SEC. 2616. ø300ff–26¿ PROVISION OF TREATMENTS.
p.001479: (a) IN GENERAL.—A State shall use a portion of the amounts provided under a grant awarded under section 2611
p.001479: to establish a program under section 2612(b)(3)(B) to provide therapeutics to treat HIV/AIDS or prevent the
p.001479: serious deterioration of health aris- ing from HIV/AIDS in eligible individuals, including measures for the
p.001479: prevention and treatment of opportunistic infections.
...

p.001507: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001507: this title.
p.001507: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing an applicant that a grant under subsection (a) is being
p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
p.001507:
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p.001507:
p.001507: January 30, 2020
p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
p.001507: (A) counseling individuals with respect to HIV/AIDS in accordance with section 2662;
p.001507: (B) testing individuals with respect to HIV/AIDS, in- cluding tests to confirm the presence of the
p.001507: disease, tests to diagnose the extent of the deficiency in the immune sys-
...

p.001563: co-payments, UCR (usual, customary and reasonable) fees, excluded services, grievance and appeals,
p.001563: and such other terms as the Secretary determines are important to define so that consumers may compare
p.001563: health insurance coverage and understand the terms of their coverage.
p.001563: (3) MEDICAL TERMS.—The medical terms described in this paragraph are hospitalization, hospital outpatient
p.001563: care, emer-
p.001563: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001565: 1565
p.001565: PUBLIC HEALTH SERVICE ACT
p.001565: Sec. 2717
p.001565:
p.001565:
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p.001565:
p.001565: January 30, 2020
p.001565: gency room care, physician services, prescription drug cov- erage, durable medical equipment, home health
p.001565: care, skilled nursing care, rehabilitation services, hospice services, emer- gency medical transportation, and
p.001565: such other terms as the Sec- retary determines are important to define so that consumers may compare the
p.001565: medical benefits offered by health insurance and understand the extent of those medical benefits (or excep- tions to
p.001565: those benefits).
p.001565: SEC. 2715A. ø300gg–15a¿ PROVISION OF ADDITIONAL INFORMATION.
p.001565: A group health plan and a health insurance issuer offering group or individual health insurance coverage
p.001565: shall comply with the provisions of section 1311(e)(3) of the Patient Protection and Affordable Care Act,
p.001565: except that a plan or coverage that is not of- fered through an Exchange shall only be required to submit the
p.001565: in- formation required to the Secretary and the State insurance com- missioner, and make such information
p.001565: available to the public.
p.001565: SEC. 2716. ø300gg–16¿ PROHIBITION ON DISCRIMINATION IN FAVOR OF HIGHLY COMPENSATED INDIVIDUALS.
p.001565: (a) IN GENERAL.—A group health plan (other than a self-in- sured plan) shall satisfy the requirements of
p.001565: section 105(h)(2) of the Internal Revenue Code of 1986 (relating to prohibition on dis- crimination in
p.001565: favor of highly compensated individuals).
p.001565: (b) RULES AND DEFINITIONS.—For purposes of this section—
p.001565: (1) CERTAIN RULES TO APPLY.—Rules similar to the rules contained in paragraphs (3), (4), and (8) of
p.001565: section 105(h) of such Code shall apply.
p.001565: (2) HIGHLY COMPENSATED INDIVIDUAL.—The term ‘‘highly compensated individual’’ has the meaning given such
p.001565: term by section 105(h)(5) of such Code.
...

p.001611: insurance coverage offered to individuals in the individual market, but does not include short-term limited
p.001611: duration insurance.
p.001611: (c) EXCEPTED BENEFITS.—For purposes of this title, the term ‘‘excepted benefits’’ means benefits under one or
p.001611: more (or any com- bination thereof) of the following:
p.001611: (1) BENEFITS NOT SUBJECT TO REQUIREMENTS.—
p.001611: (A) Coverage only for accident, or disability income in- surance, or any combination thereof.
p.001611: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001611:
p.001611:
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p.001611:
p.001611:
p.001613: 1613
p.001613: PUBLIC HEALTH SERVICE ACT
p.001613: Sec. 2791
p.001613:
p.001613: (B) Coverage issued as a supplement to liability insurance.
p.001613: (C) Liability insurance, including general liability in- surance and automobile liability insurance.
p.001613: (D) Workers’ compensation or similar insurance.
p.001613: (E) Automobile medical payment insurance.
p.001613: (F) Credit-only insurance.
p.001613: (G) Coverage for on-site medical clinics.
p.001613: (H) Other similar insurance coverage, specified in reg- ulations, under which benefits for medical care are
p.001613: sec- ondary or incidental to other insurance benefits.
p.001613: (2) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED SEPARATELY.—
p.001613: (A) Limited scope dental or vision benefits.
p.001613: (B) Benefits for long-term care, nursing home care, home health care, community-based care, or any combina- tion
p.001613: thereof.
p.001613: (C) Such other similar, limited benefits as are speci- fied in regulations.
p.001613: (3) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS INDEPENDENT, NONCOORDINATED BENEFITS.—
p.001613: (A) Coverage only for a specified disease or illness.
p.001613: (B) Hospital indemnity or other fixed indemnity insurance.
p.001613: (4) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS SEPARATE INSURANCE POLICY.—Medicare
p.001613: supplemental health insurance (as defined under section 1882(g)(1) of the So- cial Security Act), coverage
p.001613: supplemental to the coverage pro- vided under chapter 55 of title 10, United States Code, and similar
p.001613: supplemental coverage provided to coverage under a group health plan.
p.001613: (d) 29 OTHER DEFINITIONS.—
p.001613: (1) APPLICABLE STATE AUTHORITY.—The term ‘‘applicable State authority’’ means, with respect to a health
p.001613: insurance issuer in a State, the State insurance commissioner or official or officials designated by the State
p.001613: to enforce the requirements of this title for the State involved with respect to such issuer.
p.001613: (2) BENEFICIARY.—The term ‘‘beneficiary’’ has the meaning given such term under section 3(8) of the Employee Retirement
p.001613: Income Security Act of 1974.
p.001613: (3) BONA FIDE ASSOCIATION.—The term ‘‘bona fide associa- tion’’ means, with respect to health insurance coverage
p.001613: offered in a State, an association which—
p.001613: (A) has been actively in existence for at least 5 years;
...

p.001619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001619:
p.001621: 1621
p.001621: PUBLIC HEALTH SERVICE ACT
p.001621: Sec. 2802
p.001621:
p.001621: the National Association of Insurance Commissioners develop rec- ommendations for uniform reporting
p.001621: standards for such referrals.
p.001621:
p.001621: TITLE XXVIII—NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES
p.001621: Subtitle A—National All-Hazards Pre- paredness and Response Planning, Co- ordinating, and Reporting
p.001621:
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p.001621:
p.001621: January 30, 2020
p.001621: SEC. 2801. ø42 U.S.C. 300hh¿ PUBLIC HEALTH AND MEDICAL PRE- PAREDNESS AND RESPONSE FUNCTIONS.
p.001621: (a) IN GENERAL.—The Secretary of Health and Human Serv- ices shall lead all Federal public health and
p.001621: medical response to public health emergencies and incidents covered by the National Response Plan developed
p.001621: pursuant to section 502(6) of the Home- land Security Act of 2002, or any successor plan.
p.001621: (b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration with the Secretary of Veterans Affairs, the
p.001621: Secretary of Transpor- tation, the Secretary of Defense, the Secretary of Homeland Secu- rity, and the
p.001621: head of any other relevant Federal agency, shall es- tablish an interagency agreement, consistent with the
p.001621: National Re- sponse Plan or any successor plan, under which agreement the Sec- retary of Health and Human Services
p.001621: shall assume operational control of emergency public health and medical response assets, as necessary, in the
p.001621: event of a public health emergency, except that members of the armed forces under the authority of the
p.001621: Secretary of Defense shall remain under the command and control of the Sec- retary of Defense, as shall any associated
p.001621: assets of the Department of Defense.
p.001621: SEC. 2802. ø42 U.S.C. 300hh–1¿ NATIONAL HEALTH SECURITY STRAT- EGY.
p.001621: (a) IN GENERAL.—
p.001621: (1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC HEALTH EMERGENCIES.—Beginning in 2018 and
p.001621: every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a
p.001621: coordinated strategy (to be known as the National Health Security Strategy) and any revi- sions thereof, and an
p.001621: accompanying implementation plan for public health emergency preparedness and response. Such Na- tional Health
...

p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
p.001649:
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p.001649: January 30, 2020
p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
...

p.001653: (1) $30,000,000 for fiscal year 2007;
p.001653: (2) $40,000,000 for fiscal year 2008;
p.001653: (3) $53,330,000 for fiscal year 2009;
p.001653: (4) $71,110,000 for fiscal year 2010; and (5) $94,810,000 for fiscal year 2011.
p.001653:
p.001653: TITLE XXX—HEALTH INFORMATION TECHNOLOGY AND QUALITY
p.001653:
p.001653:
p.001653:
p.001653:
p.001653:
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p.001653: January 30, 2020
p.001653: SEC. 3000. ø300jj¿ DEFINITIONS.
p.001653: In this title:
p.001653: (1) CERTIFIED EHR TECHNOLOGY.—The term ‘‘certified EHR technology’’ means a qualified electronic health record
p.001653: that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are
p.001653: applicable to the type of record involved (as determined by the Secretary, such as an ambulatory
p.001653: electronic health record for office-based physicians or an inpatient hospital electronic health record for
p.001653: hospitals).
p.001653: (2) ENTERPRISE INTEGRATION.—The term ‘‘enterprise inte- gration’’ means the electronic linkage of health care
p.001653: providers, health plans, the government, and other interested parties, to enable the electronic exchange
p.001653: and use of health information among all the components in the health care infrastructure in accordance with
p.001653: applicable law, and such term includes related application protocols and other related standards.
p.001653: (3) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ includes a hospital, skilled nursing
p.001653: facility, nursing fa- cility, home health entity or other long term care facility, health care clinic,
p.001653: community mental health center (as defined in section 1913(b)(1)), renal dialysis facility, blood center, am-
p.001653: bulatory surgical center described in section 1833(i) of the So- cial Security Act, emergency medical
p.001653: services provider, Feder- ally qualified health center, group practice, a pharmacist, a pharmacy, a
p.001653: laboratory, a physician (as defined in section
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001653:
p.001653:
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p.001653:
p.001653: Sec. 3000 PUBLIC HEALTH SERVICE ACT 1654
p.001653:
p.001653: 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security
p.001653: Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in
p.001653: the Indian Self-Determina- tion and Education Assistance Act), tribal organization, or urban Indian
p.001653: organization (as defined in section 4 of the In- dian Health Care Improvement Act), a rural health
p.001653: clinic, a covered entity under section 340B, an ambulatory surgical cen- ter described in section 1833(i) of the
p.001653: Social Security Act, a therapist (as defined in section 1848(k)(3)(B)(iii) of the Social Security Act),
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p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: Sec. 3002 PUBLIC HEALTH SERVICE ACT 1666
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p.001692: (a) IN GENERAL.—
p.001692: (1) STANDARDS AND PROTOCOLS.—Not later than 180 days after the date of enactment of this title, the Secretary,
p.001692: in con- sultation with the HIT Advisory Committee, shall develop interoperable and secure standards and
p.001692: protocols that facilitate enrollment of individuals in Federal and State health and human services programs, as
p.001692: determined by the Secretary.
p.001692: (2) METHODS.—The Secretary shall facilitate enrollment in such programs through methods determined appropriate by the
p.001692: Secretary, which shall include providing individuals and third parties authorized by such individuals and their
p.001692: designees no- tification of eligibility and verification of eligibility required under such programs.
p.001692: (b) CONTENT.—The standards and protocols for electronic en- rollment in the Federal and State programs described
p.001692: in subsection
p.001692: (a) shall allow for the following:
p.001692: (1) Electronic matching against existing Federal and State data, including vital records, employment history,
p.001692: enrollment systems, tax records, and other data determined appropriate by the Secretary to serve as
p.001692: evidence of eligibility and in lieu of paper-based documentation.
p.001692: (2) Simplification and submission of electronic documenta- tion, digitization of documents, and systems verification of
p.001692: eli- gibility.
p.001692: (3) Reuse of stored eligibility information (including docu- mentation) to assist with retention of eligible
p.001692: individuals.
p.001692: (4) Capability for individuals to apply, recertify and man- age their eligibility information online,
p.001692: including at home, at points of service, and other community-based locations.
p.001692: (5) Ability to expand the enrollment system to integrate new programs, rules, and functionalities, to
p.001692: operate at in- creased volume, and to apply streamlined verification and eli- gibility processes to other
p.001692: Federal and State programs, as ap- propriate.
p.001692: (6) Notification of eligibility, recertification, and other needed communication regarding eligibility,
p.001692: which may include communication via email and cellular phones.
p.001692: (7) Other functionalities necessary to provide eligibles with streamlined enrollment process.
p.001692: (c) APPROVAL AND NOTIFICATION.—With respect to any stand- ard or protocol developed under subsection
p.001692: (a) that has been ap- proved by the HIT Advisory Committee, the Secretary—
p.001692: (1) shall notify States of such standards or protocols; and
p.001692: (2) may require, as a condition of receiving Federal funds for the health information technology investments,
p.001692: that States or other entities incorporate such standards and protocols into such investments.
p.001692: (d) GRANTS FOR IMPLEMENTATION OF APPROPRIATE ENROLL-
p.001692: MENT HIT.—
p.001692: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001692:
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p.001693: PUBLIC HEALTH SERVICE ACT
p.001693: Sec. 3022
p.001693:
p.001693: (1) IN GENERAL.—The Secretary shall award grant to eligi- ble entities to develop new, and adapt existing, technology
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p.001715: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001717: PUBLIC HEALTH SERVICE ACT
p.001717: Sec. 3312
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p.001717: January 30, 2020
p.001717: available to provide treatment and monitoring benefits under this title, with respect to all indi-
p.001717: viduals who are enrolled; and
p.001717: (ii) provide priority (subject to paragraph (3)(A)(i)) in such enrollments in the order in which individuals
p.001717: apply for enrollment under paragraph (3).
p.001717: (5) DISQUALIFICATION OF INDIVIDUALS ON TERRORIST WATCH LIST.—No individual who is on the terrorist watch
p.001717: list main- tained by the Department of Homeland Security shall qualify as an eligible WTC responder.
p.001717: Before enrolling any individual as a WTC responder in the WTC Program under paragraph (3), the Administrator, in
p.001717: consultation with the Secretary of Home- land Security, shall determine whether the individual is on such list.
p.001717: (b) MONITORING BENEFITS.—
p.001717: (1) IN GENERAL.—In the case of an enrolled WTC re- sponder (other than one described in subsection
p.001717: (a)(2)(A)(ii)), the WTC Program shall provide for monitoring benefits that include monitoring consistent
p.001717: with protocols approved by the WTC Program Administrator and including clinical examina- tions and
p.001717: long-term health monitoring and analysis. In the case of an enrolled WTC responder who is an active
p.001717: member of the Fire Department of New York City, the responder shall receive such benefits as part of the
p.001717: individual’s periodic com- pany medical exams.
p.001717: (2) PROVISION OF MONITORING BENEFITS.—The monitoring benefits under paragraph (1) shall be provided through
p.001717: the Clinical Center of Excellence for the type of individual involved or, in the case of an individual residing
p.001717: outside the New York metropolitan area, under an arrangement under section 3313.
p.001717: SEC. 3312. ø42 U.S.C. 300mm–22¿ TREATMENT OF ENROLLED WTC RE- SPONDERS FOR WTC-RELATED HEALTH CONDITIONS.
p.001717: (a) WTC-RELATED HEALTH CONDITION DEFINED.—
p.001717: (1) IN GENERAL.—For purposes of this title, the term ‘‘WTC-related health condition’’ means a condition
p.001717: that—
p.001717: (A)(i) is an illness or health condition for which expo- sure to airborne toxins, any other hazard, or any
p.001717: other ad- verse condition resulting from the September 11, 2001, ter- rorist attacks, based on an examination by
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p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
p.000001: may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned
p.000001: under this section to an entity outside of the Department of Health and Human Services for service under
p.000001: the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined
p.000001: in section 203A(a)(5)).
p.000001:
p.000001: REGULATIONS
p.000001: SEC. 215. ø216¿ (a) The President shall from time to time pre- scribe regulations with respect to the
p.000001: appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances
p.000001: (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service.
p.000001: (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall
p.000001: promulgate all other regulations necessary to the administration of the Service, includ- ing regulations
p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
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p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
p.000001: SEC. 216. ø217¿ In time of war, or of emergency proclaimed by the President, he may utilize the Service to such
p.000001: extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency
p.000001: involving the national defense pro-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001:
p.000001: Sec. 217 PUBLIC HEALTH SERVICE ACT 22
p.000001:
p.000001: claimed by the President, he may by Executive order declare the commissioned corps of the Service to be
p.000001: a military service. Upon such declaration, and during the period of such war or such emer- gency or such part
p.000001: thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the
p.000001: land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President,
...

p.000001: PART B—MISCELLANEOUS PROVISIONS
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p.000001: January 30, 2020
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p.000001: GIFTS
p.000001: SEC. 231. ø238¿ (a) The Secretary is authorized to accept on behalf of the United States gifts made
p.000001: unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of
p.000001: its functions. Conditional gifts may be so accepted if rec- ommended by the Surgeon General, and the
p.000001: principal of and in- come from any such conditional gift shall be held, invested, rein- vested, and used
p.000001: in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not
p.000001: to be met therefrom or from the income thereof unless such expenditure has been approved by Act of Congress.
p.000001: (b) Any unconditional gift of money accepted, pursuant to the authority granted in subsection (a) of this
p.000001: section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 232 PUBLIC HEALTH SERVICE ACT 50
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p.000001: this section) of any other property so accepted, and the proceeds of insurance on any such gift property not
p.000001: used for its restoration, shall be deposited in the Treasury of the United States and are hereby
p.000001: appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may
p.000001: invest and reinvest such funds in interest-bearing obligations of the United States or in obligations
p.000001: guaranteed as to both principal and inter- est by the United States. Such gifts and the income from
p.000001: such in- vestments shall be available for expenditure in the operation of the Service and the performance of its
p.000001: functions, subject to the same examination and audit as is provided for appropriations made for the
p.000001: Service by Congress.
p.000001: (c) The evidences of any unconditional gift of intangible per- sonal property, other than money, accepted
p.000001: pursuant to the author- ity granted in subsection (a) of this section shall be deposited with the Secretary of the
p.000001: Treasury and he, in his discretion, may hold them, or liquidate them except that they shall be
p.000001: liquidated upon the request of the Secretary, whenever necessary to meet payments required in the operation of
p.000001: the Service or the performance of its functions. The proceeds and income from any such property held by the
p.000001: Secretary of the Treasury shall be available for expenditure as is provided in subsection (b) of this section.
p.000001: (d) The Secretary shall hold any real property or any tangible personal property accepted unconditionally pursuant to
p.000001: the author- ity granted in subsection (a) of this section and he shall permit such property to be used
p.000001: for the operation of the Service and the performance of its functions or he may lease or hire such property, and
p.000001: may insure such property, and deposit the income thereof with the Secretary of the Treasury to be available for
p.000001: expenditure as provided in subsection (b) of this section: Provided, That the in- come from any such
p.000001: real property or tangible personal property shall be available for expenditure in the discretion of the Secretary
p.000001: for the maintenance, preservation, or repair and insurance of such property and that any proceeds from insurance may be
p.000001: used to re- store the property insured. Any such property when not required for the operation of the Service
p.000001: or the performance of its functions may be liquidated by the Secretary, and the proceeds thereof de- posited
p.000001: with the Secretary of the Treasury, whenever in his judg- ment the purposes of the gifts will be served
p.000001: thereby.
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p.000001: January 30, 2020
p.000001: USE OF IMMIGRATION STATION HOSPITALS
p.000001:
p.000001: SEC. 232. ø238a¿ The Immigration and Naturalization Service may, by agreement of the heads of the departments
p.000001: concerned, per- mit the Public Health Service to use hospitals at immigration sta- tions for the care of Public
p.000001: Health Service patients. The Surgeon General shall reimburse the Immigration and Naturalization Serv- ice for the
p.000001: actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which
p.000001: reimbursement shall be covered into the proper Immigration and Naturalization Service ap- propriation, or such
p.000001: costs may be paid from working funds estab- lished as provided by law, but no charge shall be made for the ex-
p.000001: pense of physical upkeep of the hospitals. The Immigration and Naturalization Service shall reimburse the
p.000001: Surgeon General for the
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: (1) Postdoctoral, postgraduate, and technological programs.
p.000017: (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students.
p.000017: (3) Other programs that the Surgeon General determines necessary in order to operate the Track in a
p.000017: cost-effective man- ner.
p.000017: (e) CONTINUING MEDICAL EDUCATION.—The Surgeon General shall establish programs in continuing medical education
p.000017: for mem- bers of the health professions to the end that high standards of health care may be maintained
p.000017: within the United States.
p.000017: (f) AUTHORITY OF THE SURGEON GENERAL.—
p.000017: (1) IN GENERAL.—The Surgeon General is authorized—
p.000017: (A) to enter into contracts with, accept grants from, and make grants to any nonprofit entity for the purpose
p.000017: of carrying out cooperative enterprises in medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, public health, and nursing research, consultation, and education;
p.000017: (B) to enter into contracts with entities under which the Surgeon General may furnish the services of such pro-
p.000017: fessional, technical, or clerical personnel as may be nec- essary to fulfill cooperative enterprises
p.000017: undertaken by the Track;
p.000017: (C) to accept, hold, administer, invest, and spend any gift, devise, or bequest of personal property
p.000017: made to the Track, including any gift, devise, or bequest for the sup- port of an academic chair,
p.000017: teaching, research, or dem- onstration project;
p.000017: (D) to enter into agreements with entities that may be utilized by the Track for the purpose of enhancing the ac-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: Sec. 273 PUBLIC HEALTH SERVICE ACT 70
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p.000017: January 30, 2020
p.000017:
p.000017: tivities of the Track in education, research, and techno- logical applications of knowledge; and
p.000017: (E) to accept the voluntary services of guest scholars and other persons.
p.000017: (2) LIMITATION.—The Surgeon General may not enter into any contract with an entity if the contract would
...

p.000017: under other provi- sions of this Act or any other law may be used by him to imple- ment such
p.000017: subsection, do the following:
p.000017: (1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health
p.000017: and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize
p.000017: the physical resources of such Department, provide technical assistance and advice, make grants to
p.000017: public and nonprofit private entities and indi- viduals, and, when appropriate, enter into contracts with pub-
p.000017: lic and private entities and individuals.
p.000017: (2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and
p.000017: treat- ment at such facilities.
p.000017: (3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with
p.000017: section 3109 of title 5, United States Code, the assistance and advice of con- sultants from the United States or
p.000017: abroad. The Secretary may for the purpose of carrying out the functions set forth in sec- tions 305, 2
p.000017: 306, and 309, obtain (in accordance with section 3109 of title 5 of the United States Code, but
p.000017: without regard to the limitation in such section on the number of days or the period of service) for each of the
p.000017: centers the services of not more than fifteen experts who have appropriate scientific or professional
p.000017: qualifications.
p.000017: (4) Acquire, construct, improve, repair, operate, and main- tain laboratory, research, and other necessary
p.000017: facilities and equipment, and such other real or personal property (including patents) as the Secretary deems
p.000017: necessary; and acquire, with- out regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise,
p.000017: through the Administrator of General Services, buildings or parts of buildings in the District of
p.000017: Columbia or communities located adjacent to the District of Columbia.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 1 Former section 303 was repealed by section 3201(b)(1) of Public Law 106–310 (114 Stat. 1190).
p.000017: 2 See footnote for section 306.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 79 PUBLIC HEALTH SERVICE ACT Sec. 306
p.000017:
p.000017: (c)(1) The Secretary shall coordinate all health services re- search, evaluations, and demonstrations, all
p.000017: health statistical and epidemiological activities, and all research, evaluations, and dem- onstrations
p.000017: respecting the assessment of health care technology un- dertaken and supported through units of the Department of
p.000017: Health and Human Services. To the maximum extent feasible such coordi- nation shall be carried out through the Agency
p.000017: for Health Care Pol- icy and Research and the National Center for Health Statistics.
p.000017: (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health
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p.000195: the United States Government.
p.000195: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000195: the authorities provided by this section.
p.000195: (4) AVAILABILITY OF FACILITIES TO THE SECRETARY.—In any grant, contract, or cooperative agreement entered
p.000195: into under the authority provided in this section with respect to a bio- containment laboratory or other
p.000195: related or ancillary specialized research facility that the Secretary determines necessary for the purpose of
p.000195: performing, administering, or supporting quali- fied countermeasure research and development, the Secretary
p.000195: may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be
p.000195: available as needed to the Secretary to respond to public health emergencies affect- ing national security.
p.000195: (5) TRANSFERS OF QUALIFIED COUNTERMEASURES.—Each agreement for an award of a grant, contract, or
p.000195: cooperative agreement under section 319F(e) for the development of a qualified countermeasure shall provide
p.000195: that the recipient of the award will comply with all applicable export-related controls with respect to such
p.000195: countermeasure.
p.000195: (b) EXPEDITED PROCUREMENT AUTHORITY.—
p.000195: (1) INCREASED SIMPLIFIED ACQUISITION THRESHOLD FOR QUALIFIED COUNTERMEASURE PROCUREMENTS.—
p.000195: (A) IN GENERAL.—For any procurement by the Sec- retary of property or services for use (as determined by the
p.000195: Secretary) in performing, administering, or supporting qualified countermeasure research or development
p.000195: activi- ties under this section that the Secretary determines nec- essary to respond to pressing research
p.000195: and development needs under this section, the amount specified in section 4(11) of the Office of Federal
p.000195: Procurement Policy Act (41
p.000195: U.S.C. 403(11)), as applicable pursuant to section 302A(a) of the Federal Property and Administrative Services
p.000195: Act of 1949 (41 U.S.C. 252a(a)), shall be deemed to be
p.000195: $25,000,000 in the administration, with respect to such procurement, of—
p.000195: (i) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000195: 253(g)(1)(A)) and its implementing regulations; and
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000197: PUBLIC HEALTH SERVICE ACT
p.000197: Sec. 319F–1
p.000197:
p.000197: (ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and its implementing regulations.
p.000197: (B) APPLICATION OF CERTAIN PROVISIONS.—Notwith- standing subparagraph (A) and the provision of law and
p.000197: regulations referred to in such subparagraph, each of the following provisions shall apply to procurements
p.000197: described in this paragraph to the same extent that such provisions would apply to such procurements in the
p.000197: absence of sub- paragraph (A):
p.000197: (i) Chapter 37 of title 40, United States Code (re- lating to contract work hours and safety standards).
p.000197: (ii) Subsections (a) and (b) of section 7 of the Anti- Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
p.000197: (iii) Section 304C of the Federal Property and Ad- ministrative Services Act of 1949 (41 U.S.C. 254d) (re- lating to
p.000197: the examination of contractor records).
p.000197: (iv) Section 3131 of title 40, United States Code (relating to bonds of contractors of public buildings or
p.000197: works).
p.000197: (v) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41
p.000197: U.S.C. 254(a)) (relating to contingent fees to middle- men).
p.000197: (vi) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962).
p.000197: (vii) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000197: appropriated funds for contracts with entities not meeting veterans employment reporting requirements).
p.000197: (C) INTERNAL CONTROLS TO BE INSTITUTED.—The Sec- retary shall institute appropriate internal controls for pro-
p.000197: curements that are under this paragraph, including re- quirements with regard to documenting the
p.000197: justification for use of the authority in this paragraph with respect to the procurement involved.
p.000197: (D) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this paragraph, the Secretary may not
p.000197: use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and
p.000197: open competition unless the Secretary determines that the mission of the BioShield Program under the Project
p.000197: Bio- Shield Act of 2004 would be seriously impaired without such a limitation.
p.000197: (2) PROCEDURES OTHER THAN FULL AND OPEN COMPETI- TION.—
p.000197:
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p.000197: January 30, 2020
p.000197: (A) IN GENERAL.—In using the authority provided in section 303(c)(1) of title III of the Federal Property and
p.000197: Ad- ministrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive
p.000197: procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase
p.000197: ‘‘available from only one responsible source’’ in such section 303(c)(1) shall be deemed to mean ‘‘available
p.000197: from only one responsible source or only from a limited number of responsible sources’’.
p.000197: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000197:
p.000197:
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p.000197: Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 198
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p.000197: (B) RELATION TO OTHER AUTHORITIES.—The authority under subparagraph (A) is in addition to any other author- ity to
p.000197: use procedures other than competitive procedures.
p.000197: (C) APPLICABLE GOVERNMENT-WIDE REGULATIONS.— The Secretary shall implement this paragraph in accord-
p.000197: ance with government-wide regulations implementing such section 303(c)(1) (including requirements that offers be so-
p.000197: licited from as many potential sources as is practicable under the circumstances, that required notices
p.000197: be pub- lished, and that submitted offers be considered), as such regulations apply to procurements for which
p.000197: an agency has authority to use procedures other than competitive proce- dures when the property or services
p.000197: needed by the agency are available from only one responsible source or only from a limited number of responsible
p.000197: sources and no other type of property or services will satisfy the needs of the agency.
p.000197: (3) INCREASED MICROPURCHASE THRESHOLD.—
p.000197: (A) IN GENERAL.—For a procurement described by paragraph (1), the amount specified in subsections (c), (d),
p.000197: and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428) shall be deemed
p.000197: to be $15,000 in the administration of that section with respect to such procurement.
p.000197: (B) INTERNAL CONTROLS TO BE INSTITUTED.—The Sec- retary shall institute appropriate internal controls for pur-
p.000197: chases that are under this paragraph and that are greater than $2,500.
p.000197: (C) EXCEPTION TO PREFERENCE FOR PURCHASE CARD MECHANISM.—No provision of law establishing a preference for
p.000197: using a Government purchase card method for pur- chases shall apply to purchases that are under this
p.000197: para- graph and that are greater than $2,500.
p.000197: (4) REVIEW.—
p.000197: (A) REVIEW ALLOWED.—Notwithstanding subsection (f), section 1491 of title 28, United States Code, and section
p.000197: 3556 of title 31 of such Code, review of a contracting agen- cy decision relating to a procurement described in
p.000197: para- graph (1) may be had only by filing a protest—
p.000197: (i) with a contracting agency; or
p.000197: (ii) with the Comptroller General under sub- chapter V of chapter 35 of title 31, United States
p.000197: Code.
p.000197: (B) OVERRIDE OF STAY OF CONTRACT AWARD OR PER- FORMANCE COMMITTED TO AGENCY DISCRETION.—Notwith-
p.000197: standing section 1491 of title 28, United States Code, and section 3553 of title 31 of such Code, the following author-
p.000197: izations by the head of a procuring activity are committed to agency discretion:
...

p.000211: product delivered to the ownership of the Federal Government under the contract, for such period and
p.000211: under such terms and conditions as the Secretary may specify, and in such case amounts from the special
p.000211: reserve fund as defined in subsection (h) shall be available for costs of shipping, handling, storage,
p.000211: and related costs for such product.
p.000211: (V) PRODUCT APPROVAL.—The contract shall provide that the vendor seek approval, clearance, or licensing of
p.000211: the product from the Secretary; for a timetable for the development of data and other information to support such
p.000211: approval, clearance, or licensing; and that the Secretary may waive part or all of this contract term on
p.000211: request of the vendor or on the initiative of the Secretary.
p.000211: (VI) NON-STOCKPILE TRANSFERS OF SECURITY COUNTERMEASURES.—The contract shall provide that the vendor will
p.000211: comply with all applicable ex- port-related controls with respect to such counter- measure.
p.000211: (VII) SALES EXCLUSIVITY.—The contract may provide that the vendor is the exclusive supplier of the product
p.000211: to the Federal Government for a specified period of time, not to exceed the term of the contract, on the
p.000211: condition that the vendor is able to satisfy the needs of the Government. Dur- ing the agreed period of sales
p.000211: exclusivity, the ven- dor shall not assign its rights of sales exclusivity to another entity or entities
p.000211: without approval by the Secretary. Such a sales exclusivity provision in such a contract shall constitute a
p.000211: valid basis for a sole source procurement under section 303(c)(1) of the Federal Property and Administrative
p.000211: Serv- ices Act of 1949 (41 U.S.C. 253(c)(1)).
p.000211: (VIII) WARM BASED SURGE CAPACITY.—The contract may provide that the vendor establish do- mestic
p.000211: manufacturing capacity of the product to ensure that additional production of the product is available in the
p.000211: event that the Secretary deter- mines that there is a need to quickly purchase ad- ditional quantities of the
p.000211: product. Such contract may provide a fee to the vendor for establishing and maintaining such capacity in
p.000211: excess of the ini- tial requirement for the purchase of the product. Additionally, the cost of maintaining the
p.000211: domestic
p.000211: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000211: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 212
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p.000211: manufacturing capacity shall be an allowable and allocable direct cost of the contract.
p.000211: (IX) CONTRACT TERMS.—The Secretary, in any contract for procurement under this section—
p.000211: (aa) may specify—
p.000211: (AA) the dosing and administration requirements for the countermeasure to be developed and procured;
p.000211: (BB) the amount of funding that will be dedicated by the Secretary for ad- vanced research,
p.000211: development, and pro- curement of the countermeasure; and
p.000211: (CC) the specifications the counter- measure must meet to qualify for pro- curement under a contract under
p.000211: this sec- tion; and
p.000211: (bb) shall provide a clear statement of de- fined Government purpose limited to uses re- lated to a security
p.000211: countermeasure, as defined in paragraph (1)(B).
p.000211: (iii) AVAILABILITY OF SIMPLIFIED ACQUISITION PRO- CEDURES.—
p.000211: (I) IN GENERAL.—If the Secretary determines that there is a pressing need for a procurement of a specific
p.000211: countermeasure, the amount of the pro- curement under this subsection shall be deemed to be below the threshold
p.000211: amount specified in sec- tion 4(11) of the Office of Federal Procurement Policy Act (41 U.S.C. 403(11)), for
p.000211: purposes of ap- plication to such procurement, pursuant to section 302A(a) of the Federal Property and
p.000211: Administra- tive Services Act of 1949 (41 U.S.C. 252a(a)), of— (aa) section 303(g)(1)(A) of the Federal Property
p.000211: and Administrative Services Act of 1949 (41 U.S.C. 253(g)(1)(A)) and its imple-
p.000211: menting regulations; and
p.000211: (bb) section 302A(b) of such Act (41
p.000211: U.S.C. 252a(b)) and its implementing regula- tions.
p.000211: (II) APPLICATION OF CERTAIN PROVISIONS.— Notwithstanding subclause (I) and the provision of law and
p.000211: regulations referred to in such clause, each of the following provisions shall apply to pro- curements described
p.000211: in this clause to the same ex- tent that such provisions would apply to such pro- curements in the absence of subclause
p.000211: (I):
p.000211: (aa) Chapter 37 of title 40, United States Code (relating to contract work hours and safety standards).
p.000211: (bb) Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
p.000211: (cc) Section 304C of the Federal Property and Administrative Services Act of 1949 (41
p.000211: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000213: PUBLIC HEALTH SERVICE ACT
p.000213: Sec. 319F–2
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p.000213: U.S.C. 254d) (relating to the examination of contractor records).
p.000213: (dd) Section 3131 of title 40, United States Code (relating to bonds of contractors of public
p.000213: buildings or works).
p.000213: (ee) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000213: 254(a)) (relating to con- tingent fees to middlemen).
p.000213: (ff) Section 6002 of the Solid Waste Dis- posal Act (42 U.S.C. 6962).
p.000213: (gg) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000213: appropriated funds for contracts with entities not meeting veterans employment re- porting requirements).
p.000213: (III) INTERNAL CONTROLS TO BE ESTAB- LISHED.—The Secretary shall establish appro- priate
p.000213: internal controls for procurements made under this clause, including requirements with re- spect to documentation
p.000213: of the justification for the use of the authority provided under this para- graph with respect to the
p.000213: procurement involved.
p.000213: (IV) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this subpara- graph, the
p.000213: Secretary may not use the authority provided for under subclause (I) to conduct a pro- curement on a basis other
p.000213: than full and open com- petition unless the Secretary determines that the mission of the BioShield
p.000213: Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
p.000213: (iv) PROCEDURES OTHER THAN FULL AND OPEN COMPETITION.—
p.000213: (I) IN GENERAL.—In using the authority pro- vided in section 303(c)(1) of title III of the Federal Property and
p.000213: Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in
p.000213: the case of a procure- ment under this subsection, the phrase ‘‘available from only one responsible source’’
p.000213: in such section 303(c)(1) shall be deemed to mean ‘‘available from only one responsible source or only from a limited
p.000213: number of responsible sources’’.
p.000213: (II) RELATION TO OTHER AUTHORITIES.—The authority under subclause (I) is in addition to any other authority to
p.000213: use procedures other than com- petitive procedures.
p.000213: (III) APPLICABLE GOVERNMENT-WIDE REGULA- TIONS.—The Secretary shall implement this clause in accordance with
p.000213: government-wide regulations implementing such section 303(c)(1) (including re- quirements that offers be solicited
p.000213: from as many potential sources as is practicable under the cir-
p.000213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000213: cumstances, that required notices be published, and that submitted offers be considered), as such
p.000213: regulations apply to procurements for which an agency has authority to use procedures other than competitive
p.000213: procedures when the property or serv- ices needed by the agency are available from only one responsible source or
p.000213: only from a limited number of responsible sources and no other type of property or services will satisfy
p.000213: the needs of the agency.
p.000213: (v) PREMIUM PROVISION IN MULTIPLE AWARD CON- TRACTS.—
p.000213: (I) IN GENERAL.—If, under this subsection, the Secretary enters into contracts with more than one vendor to
p.000213: procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in
p.000213: each of such contracts a provision that—
p.000213: (aa) identifies an increment of the total quantity of security countermeasure required, whether by percentage
p.000213: or by numbers of units; and
p.000213: (bb) promises to pay one or more specified premiums based on the priority of such ven- dors’ production and
p.000213: delivery of the increment identified under item (aa), in accordance with the terms and conditions of the contract.
p.000213: (II) DETERMINATION OF GOVERNMENT’S RE- QUIREMENT NOT REVIEWABLE.—If the Secretary in- cludes in each of
p.000213: a set of contracts a provision as described in subclause (I), such Secretary’s deter- mination of the
p.000213: total quantity of security counter- measure required, and any amendment of such determination, is committed to
p.000213: agency discretion.
p.000213: (vi) EXTENSION OF CLOSING DATE FOR RECEIPT OF PROPOSALS NOT REVIEWABLE.—A decision by the Sec- retary to
p.000213: extend the closing date for receipt of pro- posals for a procurement under this subsection is com- mitted to
p.000213: agency discretion.
p.000213: (vii) LIMITING COMPETITION TO SOURCES RESPOND- ING TO REQUEST FOR INFORMATION.—In conducting a
p.000213: procurement under this subsection, the Secretary may exclude a source that has not responded to a request for
p.000213: information under section 303A(a)(1)(B) of the Fed- eral Property and Administrative Services Act of 1949 (41 U.S.C.
p.000213: 253a(a)(1)(B)) if such request has given no- tice that the Secretary may so exclude such a source.
p.000213: (viii) FLEXIBILITY.—In carrying out this section, the Secretary may, consistent with the applicable pro- visions
p.000213: of this section, enter into contracts and other agreements that are in the best interest of the Govern- ment in
p.000213: meeting identified security countermeasure needs, including with respect to reimbursement of the cost of advanced
p.000213: research and development as a rea-
p.000213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000215: PUBLIC HEALTH SERVICE ACT
p.000215: Sec. 319F–2
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p.000215: sonable, allowable, and allocable direct cost of the con- tract involved.
p.000215: (8) INTERAGENCY COOPERATION.—
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p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000217: PUBLIC HEALTH SERVICE ACT
p.000217: Sec. 319F–3
p.000217:
p.000217: (1) IN GENERAL.—Subject to the other provisions of this section, a covered person shall be immune from suit and
p.000217: liabil- ity under Federal and State law with respect to all claims for loss caused by, arising out of,
p.000217: relating to, or resulting from the administration to or the use by an individual of a covered countermeasure
p.000217: if a declaration under subsection (b) has been issued with respect to such countermeasure.
p.000217: (2) SCOPE OF CLAIMS FOR LOSS.—
p.000217: (A) LOSS.—For purposes of this section, the term ‘‘loss’’ means any type of loss, including—
p.000217: (i) death;
p.000217: (ii) physical, mental, or emotional injury, illness, disability, or condition;
p.000217: (iii) fear of physical, mental, or emotional injury, illness, disability, or condition, including any need
p.000217: for medical monitoring; and
p.000217: (iv) loss of or damage to property, including busi- ness interruption loss.
p.000217: Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or
p.000217: discovery of the loss described in the clause.
p.000217: (B) SCOPE.—The immunity under paragraph (1) ap- plies to any claim for loss that has a causal
p.000217: relationship with the administration to or use by an individual of a cov- ered countermeasure, including a causal
p.000217: relationship with the design, development, clinical testing or investigation, manufacture, labeling,
p.000217: distribution, formulation, pack- aging, marketing, promotion, sale, purchase, donation, dis- pensing, prescribing,
p.000217: administration, licensing, or use of such countermeasure.
p.000217: (3) CERTAIN CONDITIONS.—Subject to the other provisions of this section, immunity under paragraph (1)
p.000217: with respect to a covered countermeasure applies only if—
p.000217: (A) the countermeasure was administered or used dur- ing the effective period of the declaration that was
p.000217: issued under subsection (b) with respect to the countermeasure;
p.000217: (B) the countermeasure was administered or used for the category or categories of diseases, health conditions,
p.000217: or threats to health specified in the declaration; and
p.000217: (C) in addition, in the case of a covered person who is a program planner or qualified person with respect to
p.000217: the administration or use of the countermeasure, the counter- measure was administered to or used by an
p.000217: individual who—
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p.000217: (i) was in a population specified by the declara- tion; and
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p.000227: (as such term is de- fined by section 201(h) of the Federal Food, Drug and Cos- metic Act (21 U.S.C. 321(h))
p.000227: that is authorized for emer- gency use in accordance with section 564, 564A, or 564B of the Federal Food,
p.000227: Drug, and Cosmetic Act.
p.000227: (2) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration or use of
p.000227: a covered countermeasure, means—
p.000227: (A) the United States; or
p.000227: (B) a person or entity that is—
p.000227: (i) a manufacturer of such countermeasure;
p.000227: (ii) a distributor of such countermeasure;
p.000227: (iii) a program planner of such countermeasure;
p.000227: (iv) a qualified person who prescribed, adminis- tered, or dispensed such countermeasure; or
p.000227: (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
p.000227: (3) DISTRIBUTOR.—The term ‘‘distributor’’ means a person or entity engaged in the distribution of drugs,
p.000227: biologics, or de- vices, including but not limited to manufacturers; repackers; common carriers; contract
p.000227: carriers; air carriers; own-label dis- tributors; private-label distributors; jobbers; brokers; ware-
p.000227: houses, and wholesale drug warehouses; independent whole- sale drug traders; and retail pharmacies.
p.000227: (4) MANUFACTURER.—The term ‘‘manufacturer’’ includes—
p.000227: (A) a contractor or subcontractor of a manufacturer;
p.000227: (B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other
p.000227: arti- cle used in the design, development, clinical testing, inves- tigation, or manufacturing of a covered
p.000227: countermeasure; and
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p.000227: (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
p.000227: (5) PERSON.—The term ‘‘person’’ includes an individual, partnership, corporation, association, entity, or
p.000227: public or pri- vate corporation, including a Federal, State, or local govern- ment agency or department.
p.000227: (6) PROGRAM PLANNER.—The term ‘‘program planner’’ means a State or local government, including an
p.000227: Indian tribe, a person employed by the State or local government, or other person who supervised or
p.000227: administered a program with respect to the administration, dispensing, distribution, provision, or use of a
p.000227: security countermeasure or a qualified pandemic or epidemic product, including a person who has
p.000227: established re- quirements, provided policy guidance, or supplied technical or scientific advice or
p.000227: assistance or provides a facility to admin- ister or use a covered countermeasure in accordance with a
p.000227: declaration under subsection (b).
p.000227: (7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘‘qualified pandemic or epidemic product’’ means a drug
p.000227: (as such term is defined in section 201(g)(1) of the Federal Food,
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p.000243: ried out pursuant to this section.
p.000243: (C) ADVANCE PAYMENTS; ADVERTISING.—The Secretary may waive the requirements of section 3324(a) of title
p.000243: 31, United States Code, or section 3709 of the Revised Stat- utes of the United States (41 U.S.C. 5)
p.000243: upon the deter- mination by the Secretary that such waiver is necessary to obtain countermeasures or products under
p.000243: this section.
p.000243: (D) MILESTONE-BASED PAYMENTS ALLOWED.—In award- ing contracts, grants, and cooperative agreements, and in
p.000243: entering into other transactions, under this section, the Secretary may use milestone-based awards and payments.
p.000243: (E) FOREIGN NATIONALS ELIGIBLE.—The Secretary may under this section award contracts, grants, and cooperative
p.000243: agreements to, and may enter into other transactions with, highly qualified foreign national persons outside
p.000243: the United States, alone or in collaboration with American participants, when such transactions may inure to
p.000243: the ben- efit of the American people.
p.000243: (F) ESTABLISHMENT OF RESEARCH CENTERS.—The Sec- retary may assess the feasibility and appropriateness of
p.000243: establishing, through contract, grant, cooperative agree- ment, or other transaction, an arrangement with an
p.000243: exist- ing research center in order to achieve the goals of this section. If such an agreement is not
p.000243: feasible and appro- priate, the Secretary may establish one or more federally- funded research and
p.000243: development centers, or university-af- filiated research centers, in accordance with section 303(c)(3) of
p.000243: the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(3)).
p.000243: (G) GOVERNMENT PURPOSE.—In awarding contracts, grants, and cooperative agreements under this section, the
p.000243: Secretary shall provide a clear statement of defined Gov- ernment purpose related to activities
p.000243: included in sub- section (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
p.000243: (6) AT-RISK INDIVIDUALS.—In carrying out the functions under this section, the Secretary may give priority
p.000243: to the ad- vanced research and development of qualified countermeasures and qualified pandemic or epidemic products
p.000243: that are likely to be safe and effective with respect to children, pregnant women,
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000243: Sec. 319L PUBLIC HEALTH SERVICE ACT 244
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p.000273: the United States, or any of their duly authorized representatives, for examination, copying or mechanical
p.000273: reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the
p.000273: Comptroller General of the United States, or any of their duly authorized representatives, shall have the
p.000273: authority to conduct such examination, copying, and reproduction.
p.000273: (o) DELEGATION OF AUTHORITY.—The Secretary may delegate the authority to administer the programs authorized
p.000273: by this section to any office, except that the authority to enter into, modify, or issue approvals with
p.000273: respect to grants or contracts may be dele- gated only within the central office of the Health
p.000273: Resources and Services Administration.
p.000273: (p) SPECIAL CONSIDERATION.—In making grants under this sec- tion, the Secretary shall give special consideration
p.000273: to the unique needs of sparsely populated rural areas, including giving priority in the awarding of grants for new
p.000273: health centers under subsections (c) and (e), and the granting of waivers as appropriate and permitted under
p.000273: subsections (b)(1)(B)(i) and (k)(3)(G).
p.000273: (q) AUDITS.—
p.000273: (1) IN GENERAL.—Each entity which receives a grant under this section shall provide for an independent annual
p.000273: financial audit of any books, accounts, financial records, files, and other papers and property which relate to
p.000273: the disposition or use of the funds received under such grant and such other funds re- ceived by or
p.000273: allocated to the project for which such grant was made. For purposes of assuring accurate, current, and
p.000273: complete disclosure of the disposition or use of the funds received, each such audit shall be conducted in accordance
p.000273: with generally ac- cepted accounting principles. Each audit shall evaluate—
p.000273: (A) the entity’s implementation of the guidelines es- tablished by the Secretary respecting cost accounting,
p.000273: (B) the processes used by the entity to meet the finan- cial and program reporting requirements of the Secretary, and
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p.000273: (C) the billing and collection procedures of the entity and the relation of the procedures to its fee
p.000273: schedule and schedule of discounts and to the availability of health in- surance and public programs to pay
p.000273: for the health services it provides.
p.000273: A report of each such audit shall be filed with the Secretary at such time and in such manner as the
p.000273: Secretary may require.
p.000273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000273: Sec. 330 PUBLIC HEALTH SERVICE ACT 274
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p.000279: Sec. 330A–1 PUBLIC HEALTH SERVICE ACT 280
p.000279: (E) a plan for sustaining the project after Federal sup- port for the project has ended;
p.000279: (F) a description of how the project will be evaluated;
p.000279: and
p.000279: (G) other such information as the Secretary deter-
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p.000279: mines to be appropriate.
p.000279: (4) EXPENDITURES FOR SMALL HEALTH CARE PROVIDER QUALITY IMPROVEMENT GRANTS.—In awarding a grant
p.000279: under this subsection, the Director shall ensure that the funds made available through the grant will be used to
p.000279: provide services to residents of rural areas. The Director shall award not less than 50 percent of the funds made
p.000279: available under this subsection to providers located in and serving rural areas.
p.000279: (h) GENERAL REQUIREMENTS.—
p.000279: (1) PROHIBITED USES OF FUNDS.—An entity that receives a grant under this section may not use funds provided
p.000279: through the grant—
p.000279: (A) to build or acquire real property; or
p.000279: (B) for construction.
p.000279: (2) COORDINATION WITH OTHER AGENCIES.—The Secretary shall coordinate activities carried out under grant
p.000279: programs described in this section, to the extent practicable, with Fed- eral and State agencies and
p.000279: nonprofit organizations that are operating similar grant programs, to maximize the effect of public dollars
p.000279: in funding meritorious proposals.
p.000279: (3) PREFERENCE.—In awarding grants under this section, the Secretary shall give preference to entities that—
p.000279: (A) are located in health professional shortage areas or medically underserved communities, or serve medically un-
p.000279: derserved populations; or
p.000279: (B) propose to develop projects with a focus on primary care, and wellness and prevention strategies.
p.000279: (i) REPORT.—Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate
p.000279: committees of Con- gress a report on the progress and accomplishments of the grant programs described in
p.000279: subsections (e), (f), and (g).
p.000279: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $45,000,000
p.000279: for each of fiscal years 2008 through 2012.
p.000279: SEC. 330A–1. ø254c–1a¿ GRANTS TO NURSE–MANAGED HEALTH CLINICS.
p.000279: (a) DEFINITIONS.—
p.000279: (1) COMPREHENSIVE PRIMARY HEALTH CARE SERVICES.—In this section, the term ‘‘comprehensive primary health
p.000279: care services’’ means the primary health services described in sec- tion 330(b)(1).
p.000279: (2) NURSE-MANAGED HEALTH CLINIC.—The term ‘‘nurse- managed health clinic’’ means a nurse-practice
p.000279: arrangement, managed by advanced practice nurses, that provides primary care or wellness services to
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p.000295: (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the
p.000295: telehealth serv- ices; and
p.000295: (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined
p.000295: by the Secretary.
p.000295: (2) TELEHEALTH RESOURCE CENTERS.—The recipient of a grant under subsection (d)(2) may use funds received
p.000295: through such grant for salaries, equipment, and operating or other costs for—
p.000295: (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care
p.000295: pro- viders and a range of health care entities that provide or will provide telehealth services;
p.000295: (B) disseminating information and research findings related to telehealth services;
p.000295: (C) promoting effective collaboration among telehealth resource centers and the Office;
p.000295: (D) conducting evaluations to determine the best utili- zation of telehealth technologies to meet health care needs;
p.000295: (E) promoting the integration of the technologies used in clinical information systems with other telehealth tech-
p.000295: nologies;
p.000295: (F) fostering the use of telehealth technologies to pro- vide health care information and education for health
p.000295: care providers and consumers in a more effective manner; and
p.000295: (G) implementing special projects or studies under the direction of the Office.
p.000295: (l) PROHIBITED USES OF FUNDS.—An entity that receives a grant under this section may not use funds made
p.000295: available through the grant—
p.000295: (1) to acquire real property;
p.000295: (2) for expenditures to purchase or lease equipment, to the extent that the expenditures would exceed 40 percent
p.000295: of the total grant funds;
p.000295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000295: Sec. 330I PUBLIC HEALTH SERVICE ACT 296
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p.000295: (3) in the case of a project involving a telehealth network, to purchase or install transmission equipment (such
p.000295: as laying cable or telephone lines, or purchasing or installing microwave towers, satellite dishes, amplifiers, or
p.000295: digital switching equip- ment);
p.000295: (4) to pay for any equipment or transmission costs not di- rectly related to the purposes for which the grant
p.000295: is awarded;
p.000295: (5) to purchase or install general purpose voice telephone systems;
p.000295: (6) for construction; or
p.000295: (7) for expenditures for indirect costs (as determined by the Secretary), to the extent that the
p.000295: expenditures would ex- ceed 15 percent of the total grant funds.
p.000295: (m) COLLABORATION.—In providing services under this section, an eligible entity shall collaborate, if feasible,
p.000295: with entities that— (1)(A) are private or public organizations, that receive Fed-
p.000295: eral or State assistance; or
p.000295: (B) are public or private entities that operate centers, or carry out programs, that receive Federal or
p.000295: State assistance; and
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p.000299: (ii) to collaborate with local public health entities to provide the mental health services; and
p.000299: (B) for the populations described in subsection (a)(3)(B)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, in long-term care
p.000299: facilities as delivered remotely by qualified men- tal health professionals using telehealth; and
p.000299: (ii) to collaborate with local public health entities to provide the mental health services.
p.000299: (2) OTHER USES.—An eligible entity that receives a grant under this section may also use the grant funds to—
p.000299: (A) pay telecommunications costs; and
p.000299: (B) pay qualified mental health professionals on a rea- sonable cost basis as determined by the Secretary for serv-
p.000299: ices rendered.
p.000299: (3) PROHIBITED USES.—An eligible entity that receives a grant under this section shall not use the grant funds
p.000299: to—
p.000299: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000299: (A) purchase or install transmission equipment (other than such equipment used by qualified mental health pro-
p.000299: fessionals to deliver mental health services using tele- health under the project involved); or
p.000299: (B) build upon or acquire real property.
p.000299: (d) EQUITABLE DISTRIBUTION.—In awarding grants under this section, the Secretary shall ensure, to the greatest
p.000299: extent possible, that such grants are equitably distributed among geographical re- gions of the United States.
p.000299: (e) APPLICATION.—An entity that desires a grant under this section shall submit an application to the
p.000299: Secretary at such time, in such manner, and containing such information as the Secretary determines to be
p.000299: reasonable.
p.000299: (f) REPORT.—Not later than 4 years after the date of enactment of the Health Care Safety Net Amendments of 2002, the
p.000299: Secretary shall prepare and submit to the appropriate committees of Con- gress a report that shall
p.000299: evaluate activities funded with grants under this section.
p.000299: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000299: $20,000,000 for fiscal year 2002 and such sums as may be necessary for fiscal years 2003 through 2006.
p.000299: SEC. 330L. ø254c–18¿ TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG STATES.
p.000299: (a) IN GENERAL.—The Secretary may make grants to State pro- fessional licensing boards to carry out programs under
p.000299: which such licensing boards of various States cooperate to develop and imple- ment State policies that
p.000299: will reduce statutory and regulatory bar- riers to telemedicine.
p.000299: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out subsection (a), there are authorized to be
p.000299: appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.
p.000299: SEC. 330M 37 ø254c–19¿ PEDIATRIC MENTAL HEALTH CARE ACCESS GRANTS.
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p.000317: (2) If the individuals in or served by a health professional shortage area are being served (as determined
p.000317: under regulations of the Secretary) by a hospital or other health care delivery facility of the Service,
p.000317: the Secretary may, in addition to such other ar- rangements as he may make under paragraph (1), arrange for the
p.000317: utilization of such hospital or facility by Corps members in pro- viding health services, but only to
p.000317: the extent that such utilization will not impair the delivery of health services and treatment
p.000317: through such hospital or facility to individuals who are entitled to health services and treatment through such
p.000317: hospital or facility.
p.000317: (c) The Secretary may make one loan to any entity with an ap- proved application under section 333 to assist such
p.000317: entity in meet- ing the costs of (1) establishing medical, dental, or other health profession practices,
p.000317: including the development of medical practice management systems; (2) acquiring equipment for use in providing health
p.000317: services; and (3) renovating buildings to establish health fa- cilities. No loan may be made under this
p.000317: subsection unless an ap- plication therefor is submitted to, and approved by, the Secretary. The amount of
p.000317: any such loan shall be determined by the Secretary, except that no such loan may exceed $50,000.
p.000317: (d) Upon the expiration of the assignment of all Corps mem- bers to a health professional shortage area, the
p.000317: Secretary may (not- withstanding any other provision of law) sell, to any appropriate local entity, equipment
p.000317: and other property of the United States uti- lized by such members in providing health services. Sales made
p.000317: under this subsection shall be made at the fair market value (as determined by the Secretary) of the
p.000317: equipment or such other prop- erty; except that the Secretary may make such sales for a lesser value to an
p.000317: appropriate local entity, if he determines that the enti- ty is financially unable to pay the full market value.
p.000317: (e)(1)(A) It shall be unlawful for any hospital to deny an au- thorized Corps member admitting
p.000317: privileges when such Corps member otherwise meets the professional qualifications established by the hospital for
p.000317: granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws,
p.000317: rules, and regulations of its medical staff.
p.000317: (B) Any hospital which is found by the Secretary, after notice and an opportunity for a hearing on the
p.000317: record, to have violated this subsection shall upon such finding cease, for a period to be de- termined by the
p.000317: Secretary, to receive and to be eligible to receive any Federal funds under this Act or under titles XVIII,
p.000317: XIX, or XXI of the Social Security Act.
p.000317: (2) For purposes of this subsection, the term ‘‘hospital’’ includes a State or local public hospital, a private
p.000317: profit hospital, a private nonprofit hospital, a general or special hospital, and any other type of hospital
p.000317: (excluding a hospital owned or operated by an agency of the Federal Government), and any related facilities.
p.000317: SEC. 336. ø254h–1¿ FACILITATION OF EFFECTIVE PROVISION OF CORPS SERVICES.
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p.000333: individual shall comply with the requirements of section 334 that apply to enti- ties; and
p.000333: (B) contain such additional provisions as the Secretary may require to carry out the objectives of this section.
p.000333: (2) The Secretary shall take such action as may be appropriate to ensure that the conditions of the written
p.000333: agreement prescribed by this subsection are adhered to.
p.000333: (c) If an individual breaches the contract entered into under section 338A or 338B by failing (for any reason)
p.000333: to begin his service obligation in accordance with an agreement entered into under sub- section (a) or to complete
p.000333: such service obligation, the Secretary may permit such individual to perform such service obligation as a
p.000333: member of the Corps.
p.000333: (d) The Secretary may pay an individual who has entered into an agreement with the Secretary under subsection
p.000333: (a) an amount to cover all or part of the individual’s expenses reasonably incurred in transporting himself, his
p.000333: family, and his possessions to the loca- tion of his private clinical practice.
p.000333: (e) Upon the expiration of the written agreement under sub- section (a), the Secretary may (notwithstanding
p.000333: any other provision of law) sell to the individual who has entered into an agreement with the Secretary
p.000333: under subsection (a), equipment and other prop- erty of the United States utilized by such individual in
p.000333: providing health services. Sales made under this subsection shall be made at the fair market value (as determined
p.000333: by the Secretary) of the equipment or such other property, except that the Secretary may make such sales
p.000333: for a lesser value to the individual if he deter- mines that the individual is financially unable to pay the
p.000333: full mar- ket value.
p.000333: (f) The Secretary may, out of appropriations authorized under section 338, pay to individuals
p.000333: participating in private practice
p.000333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000333:
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p.000333:
p.000333: Sec. 338E PUBLIC HEALTH SERVICE ACT 334
p.000333:
p.000333: under this section the cost of such individual’s malpractice insur- ance and the lesser of—
p.000333: (1)(A) $10,000 in the first year of obligated service;
p.000333: (B) $7,500 in the second year of obligated service;
p.000333: (C) $5,000 in the third year of obligated service; and
p.000333: (D) $2,500 in the fourth year of obligated service; or
p.000333: (2) an amount determined by subtracting such individual’s net income before taxes from the income the
p.000333: individual would have received as a member of the Corps for each such year of obligated service.
p.000333: (g) The Secretary shall, upon request, provide to each indi- vidual released from service obligation under
p.000333: this section technical assistance to assist such individual in fulfilling his or her agree- ment under this
p.000333: section.
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p.000343: (d) REQUIREMENT REGARDING ANNUAL BUDGET FOR OFFICE.— The Secretary may not make a grant under subsection
p.000343: (a) unless the State involved agrees that, for any fiscal year for which the State office of rural
p.000343: health receives such a grant, the office oper- ated pursuant to subsection (a) of this section will be provided
p.000343: with an annual budget of not less than $150,000.
p.000343: (e) CERTAIN USES OF FUNDS.—
p.000343: (1) RESTRICTIONS.—The Secretary may not make a grant under subsection (a) unless the State office of
p.000343: rural health in- volved agrees that the grant will not be expended—
p.000343: (A) to provide health care (including providing cash payments regarding such care);
p.000343: (B) to conduct activities for which Federal funds are expended—
p.000343: (i) within the State to provide technical and other nonfinancial assistance under section 330A(f);
p.000343: (ii) under a memorandum of agreement entered into with the State office of rural health under section 330A(h); or
p.000343: (iii) under a grant under section 338I;
p.000343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000343:
p.000343:
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p.000343:
p.000343:
p.000345: 345
p.000345: PUBLIC HEALTH SERVICE ACT
p.000345: Sec. 338K
p.000345:
p.000345: (C) to purchase medical equipment, to purchase ambu- lances, aircraft, or other vehicles, or to purchase major
p.000345: communications equipment;
p.000345: (D) to purchase or improve real property; or
p.000345: (E) to carry out any activity regarding a certificate of need.
p.000345: (2) AUTHORITIES.—Activities for which a State office of rural health may expend a grant under subsection
p.000345: (a) in- clude—
p.000345:
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p.000345:
p.000345: January 30, 2020
p.000345: (A) paying the costs of maintaining an office of rural health for purposes of subsection (a);
p.000345: (B) subject to paragraph (1)(B)(iii), paying the costs of any activity carried out with respect to recruiting
p.000345: and re- taining health professionals to serve in rural areas of the State; and
p.000345: (C) providing grants and contracts to public and non- profit private entities to carry out activities
p.000345: authorized in this section.
p.000345: (3) LIMIT ON INDIRECT COSTS.—The Secretary may impose a limit of no more than 15 percent on indirect
p.000345: costs claimed by the recipient of the grant.
p.000345: (f) REPORTS.—The Secretary may not make a grant under sub- section (a) unless the State office of rural health involved
p.000345: agrees—
p.000345: (1) to submit to the Secretary reports or performance data containing such information as the Secretary may
p.000345: require re- garding activities carried out under this section; and
p.000345: (2) to submit such a report or performance data not later than September 30 of each fiscal year
...

p.000395: patent or participate in litigation concerning the pat- ent may be provided the confidential information, pro-
p.000395: vided that the representative informs the reference product sponsor and the subsection (k) applicant of his or
p.000395: her agreement to be subject to the confidentiality provisions set forth in this paragraph, including those under
p.000395: clause (ii).
p.000395: (C) LIMITATION ON DISCLOSURE.—No person that re- ceives confidential information pursuant to subparagraph
p.000395: (B) shall disclose any confidential information to any other person or entity, including the reference product
p.000395: sponsor employees, outside scientific consultants, or other outside counsel retained by the reference product
p.000395: sponsor, without the prior written consent of the subsection (k) applicant, which shall not be unreasonably
p.000395: withheld.
p.000395: (D) USE OF CONFIDENTIAL INFORMATION.—Confidential information shall be used for the sole and exclusive pur-
p.000395: pose of determining, with respect to each patent assigned to or exclusively licensed by the reference product
p.000395: sponsor, whether a claim of patent infringement could reasonably be asserted if the subsection (k)
p.000395: applicant engaged in the manufacture, use, offering for sale, sale, or importation into the United States of
p.000395: the biological product that is the subject of the application under subsection (k).
p.000395: (E) OWNERSHIP OF CONFIDENTIAL INFORMATION.—The confidential information disclosed under this paragraph is, and
p.000395: shall remain, the property of the subsection (k) appli- cant. By providing the confidential information pursuant
p.000395: to this paragraph, the subsection (k) applicant does not provide the reference product sponsor or the outside
p.000395: coun- sel any interest in or license to use the confidential infor- mation, for purposes other than those
p.000395: specified in subpara- graph (D).
p.000395: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000395:
p.000395:
p.000395:
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p.000395:
p.000395: Sec. 351 PUBLIC HEALTH SERVICE ACT 396
p.000395:
p.000395:
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p.000395: January 30, 2020
p.000395:
p.000395: (F) EFFECT OF INFRINGEMENT ACTION.—In the event that the reference product sponsor files a patent
p.000395: infringe- ment suit, the use of confidential information shall con- tinue to be governed by the terms of
p.000395: this paragraph until such time as a court enters a protective order regarding the information. Upon
...

p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
p.000441: SEC. 363. 73 ø266¿ To protect the military and naval forces and war workers of the United States, in time of war,
p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
p.000441: prehension and examination, in time of war, of any individual rea- sonably believed (1) to be infected with such
p.000441: disease and (2) to be a probable source of infection to members of the armed forces of the
p.000441:
p.000441:
p.000441:
p.000441:
p.000441: January 30, 2020
p.000441: 73 Under section 3 of Public Law 239, 80th Congress, the date of July 25, 1947, is deemed, for purposes
p.000441: of this section, to be the date of termination of ‘‘any state of war heretofore declared by the Congress’’.
p.000441: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000441:
p.000441:
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p.000441:
p.000441: Sec. 364 PUBLIC HEALTH SERVICE ACT 442
p.000441:
p.000441: United States or to individuals engaged in the production or trans- portation of arms, munitions, ships, food,
...

p.000515: the offi- cers and employees.
p.000515: (2) Accept and administer donations to the Foundation, and administer the assets of the Foundation.
p.000515: (3) Establish a process for the selection of candidates for holding endowed positions under subsection (c).
p.000515: (4) Enter into such financial agreements as are appro- priate in carrying out the activities of the Foundation.
p.000515: (5) Take such action as may be necessary to acquire pat- ents and licenses for devices and procedures
p.000515: developed by the Foundation and the employees of the Foundation.
p.000515: (6) Adopt, alter, and use a corporate seal, which shall be judicially noticed.
p.000515: (7) Commence and respond to judicial proceedings in the name of the Foundation.
p.000515: (8) Other functions that are appropriate in the determina- tion of the Director.
p.000515: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000515:
p.000515:
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p.000515:
p.000515:
p.000517: 517
p.000517: PUBLIC HEALTH SERVICE ACT
p.000517: Sec. 399G
p.000517:
p.000517: (h) GENERAL PROVISIONS.—
p.000517: (1) AUTHORITY FOR ACCEPTING FUNDS.—The Director of the Centers for Disease Control and Prevention may accept
p.000517: and utilize, on behalf of the Federal Government, any gift, dona- tion, bequest, or devise of real or
p.000517: personal property from the Foundation for the purpose of aiding or facilitating the work of such Centers. Funds may
p.000517: be accepted and utilized by such Di- rector under the preceding sentence without regard to whether the funds are
p.000517: designated as general-purpose funds or special- purpose funds.
p.000517: (2) AUTHORITY FOR ACCEPTANCE OF VOLUNTARY SERV- ICES.—
p.000517:
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p.000517:
p.000517: January 30, 2020
p.000517: (A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal
p.000517: Gov- ernment, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or
p.000517: facilitating the work of such Centers. In the case of an individual, such Director may accept the
p.000517: services provided under the preceding sentence by the individual until such time as the private funding for such
p.000517: individual ends.
p.000517: (B) The limitation established in subparagraph (A) re- garding the period of time in which services may be
p.000517: ac- cepted applies to each individual who is not an employee of the Federal Government and who serves
p.000517: in association with the Centers for Disease Control and Prevention pur- suant to financial support from the
p.000517: Foundation.
...

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p.000517:
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p.000517:
p.000517: Sec. 399G PUBLIC HEALTH SERVICE ACT 518
p.000517:
p.000517: consideration or determination by the Foundation of any ques- tion affecting—
p.000517: (A) any direct or indirect financial interest of the indi- vidual; or
p.000517: (B) any direct or indirect financial interest of any busi- ness organization or other entity of which the individual is
p.000517: an officer or employee or in which the individual has a di- rect or indirect financial interest.
p.000517: (6) AUDITS; AVAILABILITY OF RECORDS.—The Foundation shall—
p.000517: (A) provide for biennial audits of the financial condi- tion of the Foundation; and
p.000517: (B) make such audits, and all other records, docu- ments, and other papers of the Foundation, available
p.000517: to the Secretary and the Comptroller General of the United States for examination or audit.
p.000517: (7) REPORTS.—
p.000517: (A) Not later than February 1 of each fiscal year, the Foundation shall publish a report describing the
p.000517: activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal
p.000517: year involved a com- prehensive statement of the operations, activities, financial condition, and accomplishments of
p.000517: the Foundation, includ- ing an accounting of the use of amounts provided for under subsection (i).
p.000517: (B) With respect to the financial condition of the Foun- dation, each report under subparagraph (A) shall
p.000517: include the source, and a description of, all gifts to the Foundation of real or personal property, and the source and
p.000517: amount of all gifts to the Foundation of money. Each such report shall include a specification of any
p.000517: restrictions on the pur- poses for which gifts to the Foundation may be used.
p.000517: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000517: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000517: charge not to exceed the cost of providing the copy; and
p.000517:
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p.000517: January 30, 2020
p.000517: (ii) to the appropriate committees of Congress.
p.000517: (8) LIAISON FROM CENTERS FOR DISEASE CONTROL AND PRE- VENTION.—The Director of the Centers for Disease Control
p.000517: and Prevention shall serve as the liaison representative of such Centers to the Board and the Foundation.
p.000517: (i) FEDERAL FUNDING.—
p.000517: (1) AUTHORITY FOR ANNUAL GRANTS.—
p.000517: (A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
p.000517: (i) for fiscal year 1993, make a grant to an entity described in subsection (j)(9) (relating to the establish- ment of
p.000517: a committee to establish the Foundation);
p.000517: (ii) for fiscal year 1994, make a grant to the com- mittee established under such subsection, or if the
p.000517: Foundation has been established, to the Foundation; and
p.000517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000517:
p.000517:
p.000517:
p.000517:
p.000517:
p.000517:
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p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
p.000573: (2) upon a showing of good cause, waive the requirement that the SBHC provide all required comprehensive
p.000573: primary health services for a designated period of time to be deter- mined by the Secretary.
p.000573: (f) USE OF FUNDS.—
p.000573: (1) FUNDS.—Funds awarded under a grant under this sec- tion—
p.000573:
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p.000573: January 30, 2020
p.000573: (A) may be used for—
p.000573: (i) acquiring and leasing equipment (including the costs of amortizing the principle of, and paying inter- est
p.000573: on, loans for such equipment);
p.000573: (ii) providing training related to the provision of required comprehensive primary health services and
p.000573: additional health services;
p.000573: (iii) the management and operation of health cen- ter programs;
p.000573: (iv) the payment of salaries for physicians, nurses, and other personnel of the SBHC; and
p.000573: (B) may not be used to provide abortions.
p.000573: (2) CONSTRUCTION.—The Secretary may award grants which may be used to pay the costs associated with expanding
p.000573: and modernizing existing buildings for use as an SBHC, in- cluding the purchase of trailers or
p.000573: manufactured buildings to install on the school property.
p.000573: (3) LIMITATIONS.—
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000573:
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p.000575: 575
p.000575: PUBLIC HEALTH SERVICE ACT
p.000575: Sec. 399Z–2
p.000575:
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p.000575: January 30, 2020
p.000575: (A) IN GENERAL.—Any provider of services that is de- termined by a State to be in violation of a
p.000575: State law de- scribed in subsection (a)(3)(B) with respect to activities carried out at a SBHC shall not be
p.000575: eligible to receive addi- tional funding under this section.
p.000575: (B) NO OVERLAPPING GRANT PERIOD.—No entity that has received funding under section 330 for a grant
p.000575: period shall be eligible for a grant under this section for with re- spect to the same grant period.
p.000575: (g) MATCHING REQUIREMENT.—
p.000575: (1) IN GENERAL.—Each eligible entity that receives a grant under this section shall provide, from non-Federal
...

p.000607:
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p.000607: January 30, 2020
p.000607: (11)(A) shall oversee research training for all of the na- tional research institutes and National
p.000607: Research Service Awards in accordance with section 487; and
p.000607: (B) may conduct and support research training—
p.000607: (i) for which fellowship support is not provided under section 487; and
p.000607: (ii) that does not consist of residency training of physi- cians or other health professionals;
p.000607: (12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that
p.000607: have not received significant funding relative to other matters, to re- spond to new issues and scientific
p.000607: emergencies, and to act on research opportunities of high priority;
p.000607: (13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray
p.000607: expenses for scientific, educational, and research-related conferences;
p.000607: (14) for the national research institutes and administrative entities within the National Institutes of Health—
p.000607: (A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and
p.000607: entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal
p.000607: property, and
p.000607: (B) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise
p.000607: through the Administrator of General Services, buildings or parts of buildings in the District of Columbia
p.000607: or communities lo- cated adjacent to the District of Columbia for use for a pe- riod not to exceed ten years;
p.000607: (15) may secure resources for research conducted by or through the National Institutes of Health;
p.000607: (16) may, without regard to the provisions of title 5, United States Code, governing appointments in
p.000607: the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such
p.000607: title relating to classifica- tion and General Schedule pay rates, establish such technical and scientific
p.000607: peer review groups and scientific program advi- sory committees as are needed to carry out the
p.000607: requirements of this title and appoint and pay the members of such groups, except that officers and employees of
p.000607: the United States shall not receive additional compensation for service as members of such groups;
p.000607: (17) may secure for the National Institutes of Health con- sultation services and advice of persons from the
p.000607: United States or abroad;
p.000607: (18) may use, with their consent, the services, equipment, personnel, information, and facilities of other
p.000607: Federal, State, or local public agencies, with or without reimbursement therefor;
p.000607: (19) may, for purposes of study, admit and treat at facili- ties of the National Institutes of Health
p.000607: individuals not other- wise eligible for such treatment;
...

p.000607:
p.000607: (22) may appoint physicians, dentists, and other health care professionals, subject to the provisions of
p.000607: title 5, United States Code, relating to appointments and classifications in the competitive service, and may
p.000607: compensate such professionals subject to the provisions of chapter 74 of title 38, United States Code;
p.000607: (23) shall designate a contact point or office to help innovators and physicians identify sources of
p.000607: funding available for pediatric medical device development;
p.000607: (24) implement the Cures Acceleration Network described in section 480; and
p.000607: (25) may require recipients of National Institutes of Health awards to share scientific data, to the extent
p.000607: feasible, gen- erated from such National Institutes of Health awards in a manner that is consistent with all
p.000607: applicable Federal laws and regulations, including such laws and regulations for the protec- tion of—
p.000607:
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p.000607:
p.000607: January 30, 2020
p.000607: (A) human research participants, including with re- spect to privacy, security, informed consent, and protected
p.000607: health information; and
p.000607: (B) proprietary interests, confidential commercial in- formation, and the intellectual property rights of the
p.000607: fund- ing recipient.
p.000607: The Federal Advisory Committee Act shall not apply to the dura- tion of a peer review group appointed
p.000607: under paragraph (16). The members of such a group shall be individuals who by virtue of their training or
p.000607: experience are eminently qualified to perform the re- view functions of such group. Not more than
p.000607: one-fourth of the members of any such group shall be officers or employees of the United States.
p.000607: (c) The Director of NIH may make available to individuals and entities, for biomedical and behavioral research,
p.000607: substances and living organisms. Such substances and organisms shall be made available under such terms
p.000607: and conditions (including payment for them) as the Secretary determines appropriate.
p.000607: (d)(1) The Director of NIH may obtain (in accordance with sec- tion 3109 of title 5, United States Code, but without
p.000607: regard to the limitation in such section on the period of service) the services of not more than 220
p.000607: experts or consultants, with scientific or other professional qualifications, for the National Institutes of
p.000607: Health.
p.000607: (2)(A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under
p.000607: paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States Code, for their
p.000607: travel to and from their place of service and for other expenses associated with their assignment.
p.000607: (B) Expenses specified in subparagraph (A) shall not be al- lowed in connection with the assignment of an
...

p.000681: thera- peutic substances for cancer research and set standards of safety and care for persons using such
p.000681: materials;
p.000681: (2) shall, in consultation with the advisory council for the Institute, support (A) research in the
p.000681: cancer field outside the United States by highly qualified foreign nationals which can be expected to
p.000681: benefit the American people, (B) collaborative research involving American and foreign participants, and
p.000681: (C) the training of American scientists abroad and foreign sci- entists in the United States;
p.000681: (3) shall, in consultation with the advisory council for the Institute, support appropriate programs of
p.000681: education and train- ing (including continuing education and laboratory and clinical research training);
p.000681: (4) shall encourage and coordinate cancer research by in- dustrial concerns where such concerns evidence
p.000681: a particular capability for such research;
p.000681: (5) may obtain (after consultation with the advisory council for the Institute and in accordance with section
p.000681: 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of
p.000681: service) the services of not more than one hundred and fifty-one experts or consultants who have
p.000681: scientific or professional qualifications;
p.000681: (6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve,
p.000681: repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal
p.000681: property as the Director determines necessary;
p.000681: (B) may, in consultation with the advisory council for the Institute, make grants for construction or
p.000681: renovation of facili- ties; and
p.000681: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000681: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Adminis- trator of General Services,
p.000681: buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of
p.000681: Columbia for the use of the Institute for a period not to exceed ten years;
p.000681: (7) may, in consultation with the advisory council for the Institute, appoint one or more advisory
p.000681: committees composed of such private citizens and officials of Federal, State, and local governments to advise the
p.000681: Director with respect to the Direc- tor’s functions;
p.000681: (8) may, subject to section 405(b)(2) and without regard to section 3324 of title 31, United States Code, and
p.000681: section 3709 of the Revised Statutes (41 U.S.C. 5), enter into such contracts, leases, cooperative agreements, as
p.000681: may be necessary in the conduct of functions of the Director, with any public agency, or
p.000681: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000681:
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p.000681:
p.000683: 683
p.000683: PUBLIC HEALTH SERVICE ACT
p.000683: Sec. 414
p.000683:
...

p.000699: (2) The Program shall be coordinated with other national re- search institutes to the extent that they
p.000699: have responsibilities re- specting such diseases and shall give special emphasis to the con- tinued
p.000699: development in the Institute of programs related to the causes of stroke and to effective coordination of such
p.000699: programs with related stroke programs in the National Institute of Neurological and Communicative Disorders
p.000699: and Stroke. The Director of the In- stitute, with the advice of the advisory council for the Institute,
p.000699: shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
p.000699: (b) In carrying out the Program, the Director of the Institute, under policies established by the Director of
p.000699: NIH—
p.000699: (1) may, after consultation with the advisory council for the Institute, obtain (in accordance with
p.000699: section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period
p.000699: of such service) the services of not more than one hundred experts or consultants who have sci- entific
p.000699: or professional qualifications;
p.000699: (2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve,
p.000699: repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood
p.000699: resource laboratories, research, train- ing, and other facilities, equipment, and such other real or per- sonal
p.000699: property as the Director determines necessary;
p.000699: (B) may, in consultation with the advisory council for the Institute, make grants for construction or
p.000699: renovation of facili- ties; and
p.000699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000699:
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p.000701: 701
p.000701: PUBLIC HEALTH SERVICE ACT
p.000701: Sec. 422
p.000701:
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p.000701: January 30, 2020
p.000701: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000701: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Adminis- trator of General
p.000701: Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the
p.000701: District of Columbia for the use of the Institute for a period not to exceed ten years;
p.000701: (3) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
...

p.000751: Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate
p.000751: institutes and shall con- sult with the Directors of such Institutes.
p.000751: (b) DUTIES.—In carrying out the activities described in sub- section (a), the Director of the Institute—
p.000751: (1) shall collect and disseminate through publications and other appropriate means, information pertaining
p.000751: to the re- search and other activities under this section;
p.000751: (2) shall make grants to or enter into contracts and cooper- ative agreements with individuals and public and private
p.000751: enti- ties to further the goals of the program;
p.000751: (3) may, in accordance with section 496, and in consulta- tion with the National Advisory Council on
p.000751: Drug Abuse, ac- quire, construct, improve, repair, operate, and maintain pharmacotherapeutic research
p.000751: centers, laboratories, and other
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000751:
p.000751:
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p.000751:
p.000751: Sec. 464R PUBLIC HEALTH SERVICE ACT 752
p.000751:
p.000751: necessary facilities and equipment, and such other real or per- sonal property as the Director determines necessary,
p.000751: and may, in consultation with such Advisory Council, make grants for the construction or renovation of
p.000751: facilities to carry out the pur- poses of this section;
p.000751: (4) may accept voluntary and uncompensated services;
p.000751: (5) may accept gifts, or donations of services, money, or property, real, personal, or mixed, tangible
p.000751: or intangible; and
p.000751: (6) shall take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge
p.000751: and information are maintained between the Institute and the other scientific, medical, and biomedical
p.000751: disciplines and organi- zations nationally and internationally.
p.000751: (c) REPORT.—
p.000751: (1) IN GENERAL.—Not later than December 31, 1992, and each December 31 thereafter, the Director of the
p.000751: Institute shall submit to the Office of National Drug Control Policy estab- lished under section 1002 of
p.000751: the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1501) a report, in accordance with paragraph (3), that
p.000751: describes the objectives and activities of the program as- sisted under this section.
p.000751: (2) NATIONAL DRUG CONTROL STRATEGY.—The Director of National Drug Control Policy shall incorporate, by
p.000751: reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy
p.000751: submitted the following Feb- ruary 1 under section 1005 of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
p.000751: (d) DEFINITION.—For purposes of this section, the term ‘‘pharmacotherapeutics’’ means medications used to
...

p.000821: (3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties,
p.000821: and require surety bonds or make other provisions against losses occasioned by acts of such persons;
p.000821: (4) hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of
p.000821: the offi- cers and employees;
p.000821: (5) with the consent of any executive department or inde- pendent agency, use the information, services,
p.000821: staff, and facili- ties of such in carrying out this section;
p.000821: (6) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.000821: (7) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an
p.000821: interest under this part;
p.000821: (8) establish a process for the selection of candidates for positions under subsection (c);
p.000821: (9) enter into contracts with public and private organiza- tions for the writing, editing, printing, and
p.000821: publishing of books and other material;
p.000821: (10) take such action as may be necessary to obtain pat- ents and licenses for devices and procedures
p.000821: developed by the Foundation and its employees;
p.000821: (11) solicit, accept, hold, administer, invest, and spend any gift, devise, or bequest of real or personal property
p.000821: made to the Foundation;
p.000821: (12) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion;
p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
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p.000821:
p.000821: Sec. 499 PUBLIC HEALTH SERVICE ACT 822
p.000821:
p.000821: (13) appoint other groups of advisors as may be deter- mined necessary from time to time to carry out
p.000821: the functions of the Foundation;
p.000821: (14) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion; and
p.000821: (15) exercise other powers as set forth in this section, and such other incidental powers as are necessary to
p.000821: carry out its powers, duties, and functions in accordance with this part.
p.000821: (i) ADMINISTRATIVE CONTROL.—No participant in the program established under this part shall exercise any
p.000821: administrative con- trol over any Federal employee.
p.000821: (j) GENERAL PROVISIONS.—
p.000821: (1) FOUNDATION INTEGRITY.—The members of the Board shall be accountable for the integrity of the
p.000821: operations of the Foundation and shall ensure such integrity through the devel- opment and enforcement of criteria
...

p.000821: transferred under subsection (l).
p.000821:
p.000821:
p.000821:
p.000821:
p.000821:
p.000821: January 30, 2020
p.000821: 56 Section 13(7) of Public Law 107–109 (115 Stat. 1419) provided that paragraphs (1) and (2) of section 499(j)
p.000821: are amended ‘‘by striking ‘(including those developed under subsection (d)(2)(B)(i)(II))’ each place it
p.000821: appears’’. The term to be struck appeared in paragraph (1), but not in paragraph (2).
p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
p.000821:
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p.000821:
p.000821:
p.000823: 823
p.000823: PUBLIC HEALTH SERVICE ACT
p.000823: Sec. 499
p.000823:
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p.000823: January 30, 2020
p.000823: (B) With respect to the financial condition of the Foun- dation, each report under subparagraph (A) shall
p.000823: include the source, and a description of, all gifts or grants to the Foundation of real or personal
p.000823: property, and the source and amount of all gifts or grants to the Foundation of money. Each such report
p.000823: shall include a specification of any restrictions on the purposes for which gifts or grants to the
p.000823: Foundation may be used.
p.000823: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000823: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000823: charge that shall not exceed the cost of providing the copy; and
p.000823: (ii) to the appropriate committees of Congress.
p.000823: (D) The Board shall annually hold a public meeting to summarize the activities of the Foundation and distribute
p.000823: written reports concerning such activities and the scientific results derived from such activities.
p.000823: (5) SERVICE OF FEDERAL EMPLOYEES.—Federal employees may serve on committees advisory to the Foundation
p.000823: and oth- erwise cooperate with and assist the Foundation in carrying out its function, so long as the
p.000823: employees do not direct or con- trol Foundation activities.
p.000823: (6) RELATIONSHIP WITH EXISTING ENTITIES.—The Founda- tion may, pursuant to appropriate agreements, merge with,
p.000823: ac- quire, or use the resources of existing nonprofit private cor- porations with missions similar to the
p.000823: purposes of the Founda- tion, such as the Foundation for Advanced Education in the Sciences.
p.000823: (7) INTELLECTUAL PROPERTY RIGHTS.—The Board shall adopt written standards with respect to the
p.000823: ownership of any intellectual property rights derived from the collaborative ef- forts of the Foundation prior
p.000823: to the commencement of such ef- forts.
p.000823: (8) NATIONAL INSTITUTES OF HEALTH AMENDMENTS OF 1990.—The activities conducted in support of the
p.000823: National Insti- tutes of Health Amendments of 1990 (Public Law 101–613), and the amendments made by such
p.000823: Act, shall not be nullified by the enactment of this section.
p.000823: (9) LIMITATION OF ACTIVITIES.—
p.000823: (A) IN GENERAL.—The Foundation shall exist solely as an entity to work in collaboration with the research pro-
p.000823: grams of the National Institutes of Health. The Founda- tion may not undertake activities (such as the
p.000823: operation of independent laboratories or competing for Federal research funds) that are independent of those of the
p.000823: National Insti- tutes of Health research programs.
p.000823: (B) GIFTS, GRANTS, AND OTHER DONATIONS.—
p.000823: (i) IN GENERAL.—Gifts, grants, and other dona- tions to the Foundation may be designated for pedi- atric
p.000823: research and studies on drugs, and funds so des- ignated shall be used solely for grants for research and studies under
p.000823: subsection (c)(1)(C).
p.000823: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000823:
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p.000823: Sec. 499 PUBLIC HEALTH SERVICE ACT 824
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p.000841: orientation and training for new members of the advisory council to provide for their effective par-
p.000841: ticipation in the functions of the advisory council.
p.000841: REPORTS ON ALCOHOLISM, ALCOHOL ABUSE, AND DRUG ABUSE
p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
...

p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
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p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
p.000933:
p.000933: segregated to the extent appropriate in the treatment of the children involved; or
p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
p.000933: (B) with respect to subparagraph (D) of such para- graph, to authorize the system of care to expend the grant
p.000933: under section 561(a) (or the non-Federal contributions made with respect to the grant) to provide
p.000933: legal services or any service with respect to which expenditures regard- ing the grant are prohibited under
p.000933: subsection (d)(1)(B).
p.000933: (f) RESTRICTIONS ON USE OF GRANT.—A funding agreement for a grant under section 561(a) is that the grant, and
p.000933: the non-Federal contributions made with respect to the grant, will not be ex- pended—
p.000933: (1) to purchase or improve real property (including the construction or renovation of facilities);
p.000933: (2) to provide for room and board in residential programs serving 10 or fewer children;
p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
...

p.000967: fiscal year ending June 30, 1972, $1,000,000,000; and for each of the fiscal years ending June 30, 1973, and June 30,
p.000967: 1974.
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p.000967: January 30, 2020
p.000967: LOAN GUARANTEE AND LOAN FUND
p.000967: SEC. 626. ø291j–6¿ (a)(1) There is hereby established in the Treasury a loan guarantee and loan fund
p.000967: (hereinafter in this sec- tion referred to as the ‘‘fund’’) which shall be available to the Sec- retary without
p.000967: fiscal year limitation, in such amounts as may be specified from time to time in appropriations Acts, (i) to
p.000967: enable him to discharge his responsibilities under guarantees issued by him under this part, (ii) for
p.000967: payment of interest on the loans to non- profit agencies which are guaranteed, (iii) for direct loans to public
p.000967: agencies which are sold and guaranteed, (iv) for payment of inter- est with respect to such loans, and (v)
p.000967: for repurchase by him of di- rect loans to public agencies which have been sold and guaranteed. There are authorized
p.000967: to be appropriated to the fund from time to time such amounts as may be necessary to provide capital required
p.000967: for the fund. To the extent authorized from time to time in appro- priation Acts, there shall be deposited in
p.000967: the fund amounts re- ceived by the Secretary as interest payments or repayments of principal on loans
p.000967: and any other moneys, property, or assets de- rived by him from his operations under this part,
p.000967: including any moneys derived from the sale of assets.
p.000967: (2) Of the moneys in the fund, there shall be available to the
p.000967: Secretary for the purpose of making of direct loans to public agen-
p.000967: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000967:
p.000967:
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p.000967:
p.000969: 969
p.000969: PUBLIC HEALTH SERVICE ACT
p.000969: Sec. 627
p.000969:
p.000969: cies only such sums as shall have been appropriated for such pur- pose pursuant to section 627 or sums received
p.000969: by the Secretary from the sale of such loans (in accordance with such section) and authorized in
p.000969: appropriations Acts to be used for such purpose.
p.000969: (b) If at any time the moneys in the fund are insufficient to enable the Secretary to discharge his
p.000969: responsibilities under this part—
p.000969:
p.000969: (i) 3 to make payments of interest on loans to nonprofit pri- vate agencies which he has guaranteed under this part;
p.000969: (ii) 3 to otherwise comply with guarantees under this part of loans to nonprofit private agencies;
p.000969: (iii) 3 to make payments of interest subsidies with respect to loans to public agencies which he has made,
p.000969: sold, and guar- anteed under this part;
p.000969: (iv) 3 in the event of default by public agencies to make payments of principal and interest on loans
p.000969: which the Sec- retary has made, sold, and guaranteed, under this part, to make such payments to the
...

p.000991: hospitals with which such borrowers may be associated, and any other relevant organizations.
p.000991: (d) ALLOCATION OF FUNDS FOR OFFICE.—In the case of amounts reserved under section 710(a)(2)(B)
p.000991: for obligation under this subsection, the Secretary may obligate the amounts for the purpose of
p.000991: administering the Office, including 7 full-time equiva- lent employment positions for such Office. With
p.000991: respect to such purpose, amounts made available under the preceding sentence are in addition to amounts made
p.000991: available to the Health Resources and Services Administration for program management for the fiscal year
p.000991: involved. With respect to such employment positions, the posi- tions are in addition to the number of full-time
p.000991: equivalent employ- ment positions that otherwise is authorized for the Department of Health and Human Services
p.000991: for the fiscal year involved.
p.000991: SEC. 710. ø292i¿ INSURANCE ACCOUNT.
p.000991: (a) IN GENERAL.—
p.000991: (1) ESTABLISHMENT.—There is hereby established a stu- dent loan insurance account (in this section
p.000991: referred to as the ‘‘Account’’) which shall be available without fiscal year limita- tion to the
p.000991: Secretary for making payments in connection with the collection and default of loans insured under this
p.000991: subpart by the Secretary.
p.000991: (2) FUNDING.—
p.000991: (A) Except as provided in subparagraph (B), all amounts received by the Secretary as premium charges for
p.000991: insurance and as receipts, earnings, or proceeds derived from any claim or other assets acquired by the
p.000991: Secretary in connection with his operations under this subpart, and any other moneys, property, or assets
p.000991: derived by the Sec- retary from the operations of the Secretary in connection with this section, shall be
p.000991: deposited in the Account.
p.000991: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000991:
p.000991:
p.000991:
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p.000991:
p.000991: Sec. 711 PUBLIC HEALTH SERVICE ACT 992
p.000991:
p.000991:
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p.000991:
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p.000991: January 30, 2020
p.000991:
p.000991: (B) With respect to amounts described in subpara- graph (A) that are received by the Secretary for fiscal year
p.000991: 1993 and subsequent fiscal years, the Secretary may, be- fore depositing such amounts in the Account, reserve
p.000991: from the amounts each such fiscal year not more than
p.000991: $1,000,000 for obligation under section 709(d).
p.000991: (3) EXPENDITURES.—All payments in connection with the default of loans insured by the Secretary under
p.000991: this subpart shall be paid from the Account.
p.000991: (b) CONTINGENT AUTHORITY FOR ISSUANCE OF NOTES OR OTHER OBLIGATIONS.—If at any time the moneys in the Account
p.000991: are insuf- ficient to make payments in connection with the collection or de- fault of any loan insured
p.000991: by the Secretary under this subpart, the Secretary of the Treasury may lend the Account such amounts as
p.000991: may be necessary to make the payments involved, subject to the Federal Credit Reform Act of 1990.
p.000991: SEC. 711. ø292j¿ POWERS AND RESPONSIBILITIES OF SECRETARY.
p.000991: (a) IN GENERAL.—In the performance of, and with respect to, the functions, powers, and duties vested in
p.000991: the Secretary by this subpart, the Secretary is authorized as follows:
p.000991: (1) To prescribe such regulations as may be necessary to carry out the purposes of this subpart.
p.000991: (2) To sue and be sued in any district court of the United States. Such district courts shall have jurisdiction
p.000991: of civil ac- tions arising under this subpart without regard to the amount in controversy, and any action instituted
p.000991: under this subsection by or against the Secretary shall survive notwithstanding any change in the person
p.000991: occupying the office of Secretary or any vacancy in that office. No attachment, injunction, garnishment, or other
p.000991: similar process, mesne or final, shall be issued against the Secretary or property under the control of the
p.000991: Secretary. Nothing herein shall be constructed to except litigation arising out of activities under this subpart from
p.000991: the application of sec- tions 517 and 547 of title 28 of the United States Code.
p.000991: (3) To include in any contract for Federal loan insurance
p.000991: such terms, conditions, and covenants relating to repayment of principal and payments of interest, relating to
p.000991: his obligations and rights and to those of eligible lenders, and borrowers in case of default, and relating
p.000991: to such other matters as the Sec- retary determines to be necessary to assure that the purposes of this
p.000991: subpart will be achieved. Any term, condition, and cov- enant made pursuant to this paragraph or any other provisions
p.000991: of this subpart may be modified by the Secretary if the Sec- retary determines that modification is
p.000991: necessary to protect the financial interest of the United States.
p.000991: (4) Subject to the specific limitations in the subpart, to consent to the modification of any note or other
p.000991: instrument evi- dencing a loan which has been insured by him under this sub- part (including modifications with
p.000991: respect to the rate of inter- est, time of payment of any installment of principal and inter- est or any portion
p.000991: thereof, or any other provision).
p.000991: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000991:
p.000991:
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p.001157:
p.001157: January 30, 2020
p.001157: SEC. 946. ø299c–5¿ CERTAIN ADMINISTRATIVE AUTHORITIES.
p.001157: (a) DEPUTY DIRECTOR AND OTHER OFFICERS AND EMPLOYEES.—
p.001157: (1) DEPUTY DIRECTOR.—The Director may appoint a deputy director for the Agency.
p.001157: (2) OTHER OFFICERS AND EMPLOYEES.—The Director may appoint and fix the compensation of such officers
p.001157: and employ- ees as may be necessary to carry out this title. Except as other- wise provided by law, such officers and
p.001157: employees shall be ap- pointed in accordance with the civil service laws and their com- pensation fixed in accordance
p.001157: with title 5, United States Code.
p.001157: (b) FACILITIES.—The Secretary, in carrying out this title—
p.001157: (1) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the
p.001157: Admin- istrator of General Services, buildings or portions of buildings in the District of Columbia or
p.001157: communities located adjacent to the District of Columbia for use for a period not to exceed 10 years; and
p.001157: (2) may acquire, construct, improve, repair, operate, and maintain laboratory, research, and other
p.001157: necessary facilities and equipment, and such other real or personal property (in- cluding patents) as the
p.001157: Secretary deems necessary.
p.001157: (c) PROVISION OF FINANCIAL ASSISTANCE.—The Director, in car- rying out this title, may make grants to public and
p.001157: nonprofit enti- ties and individuals, and may enter into cooperative agreements or contracts with public and private
p.001157: entities and individuals.
p.001157: (d) UTILIZATION OF CERTAIN PERSONNEL AND RESOURCES.—
p.001157: (1) DEPARTMENT OF HEALTH AND HUMAN SERVICES.—The Director, in carrying out this title, may utilize
p.001157: personnel and equipment, facilities, and other physical resources of the De- partment of Health and Human
p.001157: Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the
p.001157: physical resources of such Department, and provide technical assistance and advice.
p.001157: (2) OTHER AGENCIES.—The Director, in carrying out this title, may use, with their consent, the services,
p.001157: equipment, per- sonnel, information, and facilities of other Federal, State, or local public agencies, or
p.001157: of any foreign government, with or without reimbursement of such agencies.
p.001157: (e) CONSULTANTS.—The Secretary, in carrying out this title, may secure, from time to time and for such periods
p.001157: as the Director deems advisable but in accordance with section 3109 of title 5, United States Code, the
p.001157: assistance and advice of consultants from the United States or abroad.
p.001157: (f) EXPERTS.—
p.001157: (1) IN GENERAL.—The Secretary may, in carrying out this title, obtain the services of not more than 50
p.001157: experts or con- sultants who have appropriate scientific or professional quali- fications. Such experts or
...

p.001187:
p.001187:
p.001187:
p.001187: January 30, 2020
p.001187: (A) there is no system of access to emergency medical services through the telephone number 911;
p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001187:
p.001187:
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p.001187:
p.001187: Sec. 1215 PUBLIC HEALTH SERVICE ACT 1188
p.001187:
p.001187: (B) there is no basic life-support system; or
p.001187: (C) there is no advanced life-support system; and
p.001187: (2) the State submits to the Secretary a list of rural areas identified pursuant to paragraph (1) or, if there
p.001187: are no such areas, a statement that there are no such areas.
p.001187: SEC. 1215. ø300d–15¿ RESTRICTIONS ON USE OF PAYMENTS.
p.001187: (a) IN GENERAL.—The Secretary may not, except as provided in subsection (b), make payments under section 1211(a)
p.001187: for a fiscal year unless the State involved agrees that the payments will not be expended—
p.001187: (1) for any purpose other than developing, implementing, and monitoring the modifications required by section
p.001187: 1211(b) to be made to the State plan for the provision of emergency med- ical services;
p.001187: (2) to make cash payments to intended recipients of serv- ices provided pursuant to this section;
p.001187: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property);
p.001187: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001187: of Federal funds; or
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p.001187: January 30, 2020
p.001187: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.001187: (b) WAIVER.—The Secretary may waive a restriction under sub- section (a) only if the Secretary determines that the
p.001187: activities out- lined by the State plan submitted under section 1214(a) by the State involved cannot
p.001187: otherwise be carried out.
p.001187: SEC. 1217. ø300d–17¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001187: The Secretary may not make payments under section 1211(a) to a State for a fiscal year unless—
p.001187: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001187: accordance with this part;
p.001187: (2) the agreements are made through certification from the chief executive officer of the State;
p.001187: (3) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001187: Secretary;
p.001187: (4) the application contains the plan provisions and the in- formation required to be submitted to the Secretary
p.001187: pursuant to section 1214; and
...

p.001227: (3) After any loan under this title to a public health mainte- nance organization has been sold and
p.001227: guaranteed under this sub- section, interest paid on such loan which is received by the pur- chaser
p.001227: thereof (or his successor in interest) shall be included in the gross income of the purchaser of the loan (or his
p.001227: successor in inter- est) for the purpose of chapter 1 of the Internal Revenue Code of 1954.
p.001227: (4) Amounts received by the Secretary as proceeds from the sale of loans under this subsection shall be
p.001227: deposited in the loan fund established under subsection (e).
p.001227: (5) Any reference in this title (other than in this subsection and in subsection (d)) to a loan guarantee
p.001227: under this title does not include a loan guarantee made under this subsection.
p.001227: (d)(1) There is established in the Treasury a loan guarantee fund (hereinafter in this subsection referred to
p.001227: as the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts as may be
p.001227: specified from time to time in appropria- tion Acts, to enable him to discharge his responsibilities under loan
p.001227: guarantees issued by him under this title and to take the action authorized by subsection (f). There
p.001227: are authorized to be appro- priated from time to time such amounts as may be necessary to provide the
p.001227: sums required for the fund. To the extent authorized in appropriation Acts, there shall also be
p.001227: deposited in the fund amounts received by the Secretary in connection with loan guaran- tees under this title
p.001227: and other property or assets derived by him from his operations respecting such loan guarantees, including any
p.001227: money derived from the sale of assets.
p.001227: (2) If at any time the sums in the funds are insufficient to en- able the Secretary to discharge his
p.001227: responsibilities under guaran- tees issued by him before October 1, 1986, under this title and to take
p.001227: the action authorized by subsection (f), he is authorized to issue to the Secretary of the Treasury notes or
p.001227: other obligations in such forms and denominations, bearing such maturities, and sub- ject to such terms and
p.001227: conditions, as may be prescribed by the Sec- retary with the approval of the Secretary of Treasury. Such
p.001227: notes or other obligations shall bear interest at a rate determined by the
p.001227: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001229: 1229
p.001229: PUBLIC HEALTH SERVICE ACT
p.001229: Sec. 1310
p.001229:
p.001229: Secretary of the Treasury, taking into consideration the current av- erage market yield on outstanding marketable
p.001229: obligations of the United States of comparable maturities during the month pre- ceding the issuance of the
p.001229: notes or other obligations. The Secretary of the Treasury shall purchase any notes and other obligations
p.001229: issued under this paragraph and for that purpose he may use as a public debt transaction the proceeds from
p.001229: the sale of any securi- ties issued under the Second Liberty Bond Act, and the purposes for which the
p.001229: securities may be issued under that Act are extended to include any purchase of such notes and obligations.
p.001229: The Sec- retary of the Treasury may at any time sell any of the notes or other obligations acquired by
p.001229: him under this paragraph. All re- demptions, purchases, and sales by the Secretary of the Treasury of
p.001229: such notes or other obligations shall be treated as public debt transactions of the United States. Sums
p.001229: borrowed under this para- graph shall be deposited in the fund and redemption of such notes and obligations shall be
p.001229: made by the Secretary from the fund.
p.001229: (e) There is established in the Treasury a loan fund (herein- after in this subsection referred to as
p.001229: the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts
p.001229: as may be specified from time to time in appropriation Acts, to enable him to make loans under this title and
p.001229: to take the action authorized by subsection (f). There shall also be deposited in the fund amounts received by the
p.001229: Secretary as interest payments and repayment of principal on loans made under this title and other
p.001229: property or assets derived by him from his operations re- specting such loans, from the sale of loans
p.001229: under subsection (c) of this section, or from the sale of assets.
p.001229: (f) The Secretary may take such action as he deems appro- priate to protect the interest of the United
p.001229: States in the event of a default on a loan made or guaranteed under this title, including taking possession of,
p.001229: holding, and using real property pledged as security for such a loan or loan guarantee.
p.001229: AUTHORIZATIONS OF APPROPRIATIONS
p.001229: SEC. 1309. ø300e–8¿ (a) For grants under section 1317 there is authorized to be appropriated $1,000,000
p.001229: for each of the fiscal years 1982, 1983, and 1984.
p.001229: (b) To meet the obligations of the loan fund established under section 1308(e) resulting from defaults on loans
p.001229: made from the fund and to meet the other obligations of the fund, there is author- ized to be appropriated to the
p.001229: loan fund for fiscal years 1987, 1988, and 1989, such sums as may be necessary.
p.001229: EMPLOYEES’ HEALTH BENEFITS PLANS
p.001229: SEC. 1310. 3 ø300e–9¿ (a) In accordance with regulations which the Secretary shall prescribe—
p.001229:
p.001229:
p.001229:
p.001229:
p.001229:
p.001229:
p.001229:
p.001229: January 30, 2020
p.001229: 3 Section 1310 as shown above was added by section 7(b) of Public Law 100–517. Such section provided in part as
p.001229: follows: ‘‘Effective 7 years after the date of the enactment of this Act øOcto- ber 24, 1988¿, section 1310 (42 U.S.C.
p.001229: 300e–9) is amended to read as follows’’.
p.001229: Section 7(a)(3) of such Public Law provides that nothing in section 1310 shall be construed to supersede
p.001229: any provision of a collective bargaining agreement in effect on øOctober 24, 1988¿.
p.001229: Continued
p.001229: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001229:
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p.001235: Sec. 1318 PUBLIC HEALTH SERVICE ACT 1236
p.001235:
p.001235: tenance organizations. The Secretary may provide such technical assistance through grants to public and
p.001235: nonprofit private entities and contracts with public and private entities.
p.001235: (c) The authority of the Secretary to enter into contracts under subsections (a) and (b) shall be effective for any
p.001235: fiscal year only to such extent or in such amounts as are provided in advance by ap- propriation Acts.
p.001235: FINANCIAL DISCLOSURE
p.001235: SEC. 1318. ø300e–17¿ (a) Each health maintenance organiza- tion shall, in accordance with regulations of
p.001235: the Secretary, report to the Secretary financial information which shall include the fol- lowing:
p.001235: (1) Such information as the Secretary may require dem- onstrating that the health maintenance organization has
p.001235: a fis- cally sound operation.
p.001235: (2) A copy of the report, if any, filed with the Centers for Medicare & Medicaid Services containing
p.001235: the information re- quired to be reported under section 1124 of the Social Security Act by disclosing entities
p.001235: and the information required to be supplied under section 1902(a)(38) of such Act.
p.001235: (3) A description of transactions, as specified by the Sec- retary, between the health maintenance
p.001235: organization and a party in interest. Such transactions shall include—
p.001235: (A) any sale or exchange, or leasing of any property between the health maintenance organization and a party
p.001235: in interest;
p.001235: (B) any furnishing for consideration of goods, services (including management services), or facilities
p.001235: between the health maintenance organization and a party in interest, but not including salaries paid to
p.001235: employees for services provided in the normal course of their employment and health services provided
p.001235: to members by hospitals and other providers and by staff, medical group (or groups), in- dividual practice
p.001235: association (or associations), or any com- bination thereof; and
p.001235: (C) any lending of money or other extension of credit between a health maintenance organization and a party in
p.001235: interest.
p.001235: The Secretary may require that information reported respecting a health maintenance organization which
p.001235: controls, is controlled by, or is under common control with, another entity be in the form of a
p.001235: consolidated financial statement for the organization and such entity.
p.001235: (b) For the purposes of this section the term ‘‘party in interest’’ means:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235:
p.001235: January 30, 2020
p.001235: (1) any director, officer, partner, or employee responsible for management or administration of a health
p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
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p.001251:
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p.001251:
p.001251: January 30, 2020
p.001251: (5) If any loan to a public entity under this part is sold and guaranteed by the Secretary under this
p.001251: subsection, interest paid on such loan after its sale and any interest subsidy paid, under para- graph (3)(A)(ii), by
p.001251: the Secretary with respect to such loan which is received by the purchaser of the loan (or the
p.001251: purchaser’s suc- cessor in interest) shall be included in the gross income of the pur- chaser or successor for the
p.001251: purpose of chapter 1 of the Internal Revenue Code of 1954.
p.001251: (d)(1) There is established in the Treasury a loan and loan guarantee fund (hereinafter in this
p.001251: subsection referred to as the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation,
p.001251: in such amounts as may be specified from time to time in appropriation Acts—
p.001251: (A) to enable him to make loans under this part,
p.001251: (B) to enable him to discharge his responsibilities under loan guarantees issued by him under this part,
p.001251: (C) for payment of interest under section 1601(a)(2)(B) on loans guaranteed under this part,
p.001251: (D) for repurchase of loans under subsection (c)(3)(B),
p.001251: (E) for payment of interest on loans which are sold and guaranteed, and
p.001251: (F) to enable the Secretary to take the action authorized by subsection (f).
p.001251: There are authorized to be appropriated from time to time such amounts as may be necessary to provide the
p.001251: sums required for the fund. There shall also be deposited in the fund amounts received by the Secretary in
p.001251: connection with loans and loan guarantees under this part and other property or assets derived by him
p.001251: from his operations respecting such loans and loan guarantees, including any money derived from the sale of assets.
p.001251: (2) If at any time the sums in the funds are insufficient to en- able the Secretary—
p.001251: (A) to make payments of interest under section 1601(a)(2)(B),
p.001251: (B) to otherwise comply with guarantees under this part of loans to nonprofit private entities,
p.001251: (C) in the case of a loan which was made, sold, and guar- anteed under this part, to make to the purchaser of such loan
p.001251: payments of principal and interest on such loan after default by the entity to which the loan was made, or
p.001251: (D) to repurchase loans under subsection (c)(3)(B),
p.001251: (E) to make payments of interest on loans which are sold and guaranteed, and
p.001251: (F) to enable the Secretary to take the action authorized by subsection (f),
p.001251: he is authorized to issue to the Secretary of the Treasury notes or other obligations in such forms and
p.001251: denominations bearing such maturities, and subject to such terms and conditions, as may be prescribed by
p.001251: the Secretary with the approval of the Secretary of the Treasury. Such notes or other obligations shall bear
p.001251: interest at a rate determined by the Secretary of the Treasury, taking into consideration the current
p.001251: average market yield on outstanding marketable obligations of the United States of comparable matu- rities
p.001251: during the month preceding the issuance of the notes or other
p.001251: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001251:
p.001251:
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p.001251: (2) To provide additional capitalization for the fund established under subsection (d) there are authorized to be
p.001251: appropriated to the fund, such sums as may be necessary for the fiscal years ending June 30, 1975, June
p.001251: 30, 1976, September 30, 1977, September 30, 1978, September 30, 1979, September 30, 1980, September 30,
p.001251: 1981, and September 30, 1982.
p.001251: (f)(1) The Secretary may take such action as may be necessary to prevent a default on a loan made or guaranteed under
p.001251: this part or under title VI, including the waiver of regulatory conditions, de- ferral of loan payments, renegotiation
p.001251: of loans, and the expenditure of funds for technical and consultative assistance, for the tem- porary payment
p.001251: of the interest and principal on such a loan, and for other purposes. Any such expenditure made under
p.001251: the pre- ceding sentence on behalf of a medical facility shall be made under such terms and conditions as the
p.001251: Secretary shall prescribe, includ- ing the implementation of such organizational, operational, and fi- nancial reforms
p.001251: as the Secretary determines are appropriate and the disclosure of such financial or other information as
p.001251: the Sec- retary may require to determine the extent of the implementation of such reforms.
p.001251: (2) The Secretary may take such action, consistent with State law respecting foreclosure procedures, as
p.001251: he deems appropriate to protect the interest of the United States in the event of a default on a loan
p.001251: made or guaranteed under this part or under title VI, in- cluding selling real property pledged as security for such a
p.001251: loan or loan guarantee and for a reasonable period of time taking posses- sion of, holding, and using
p.001251: real property pledged as security for such a loan or loan guarantee.
p.001251: PART B—PROJECT GRANTS
p.001251:
p.001251:
p.001251:
p.001251:
p.001251:
p.001251: January 30, 2020
p.001251: PROJECT GRANTS
p.001251: SEC. 1610. ø300r¿ (a)(1)(A) The Secretary may make grants for construction or modernization projects designed to—
p.001251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001253: 1253
p.001253: PUBLIC HEALTH SERVICE ACT
p.001253: Sec. 1610
p.001253:
p.001253: (i) eliminate or prevent in medical facilities imminent safe- ty hazards as defined by Federal, State, or local fire,
p.001253: building, or life safety codes or regulations, or
p.001253: (ii) avoid noncompliance by medical facilities with State or voluntary licensure or accreditation standards.
p.001253: (B) A grant under subparagraph (A) may only be made to—
p.001253: (i) a State or political subdivision of a State, including any city, town, county, borough, hospital district
p.001253: authority, or pub- lic or quasi-public corporation, for any medical facility owned or operated by the State or
p.001253: political subdivision; and
p.001253: (ii) a nonprofit private entity for any medical facility owned or operated by the entity but only if
p.001253: the Secretary deter- mines—
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p.001413: January 30, 2020
p.001413:
p.001413: to the extent practicable, be made not later than 30 days after the date on which the Director
p.001413: receives amounts under paragraph (2).
p.001413: SEC. 2354. ø300cc–41¿ ADDITIONAL AUTHORITIES.
p.001413: (a) IN GENERAL.—In carrying out AIDS research, the Director of the Office—
p.001413: (1) shall develop and expand clinical trials of treatments and therapies for infection with the etiologic agent
p.001413: for acquired immune deficiency syndrome, including such clinical trials for women, infants, children,
p.001413: hemophiliacs, and minorities;
p.001413: (2) may establish or support the large-scale development and preclinical screening, production, or distribution
p.001413: of special- ized biological materials and other therapeutic substances for AIDS research and set standards of
p.001413: safety and care for persons using such materials;
p.001413: (3) may support—
p.001413: (A) AIDS research conducted outside the United States by qualified foreign professionals if such
p.001413: research can reasonably be expected to benefit the people of the United States;
p.001413: (B) collaborative research involving American and for- eign participants; and
p.001413: (C) the training of American scientists abroad and for- eign scientists in the United States;
p.001413: (4) may encourage and coordinate AIDS research con- ducted by any industrial concern that evidences
p.001413: a particular capability for the conduct of such research;
p.001413: (5)(A) may acquire, improve, repair, operate, and maintain laboratories, other research facilities, equipment,
p.001413: and such other real or personal property as the Director of the Office de- termines necessary;
p.001413: (B) may make grants for the construction or renovation of facilities; and
p.001413: (C) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34) by lease or otherwise through the
p.001413: Adminis- trator of General Services, buildings or parts of buildings in the District of Columbia or
p.001413: communities located adjacent to the District of Columbia for the use of the National Institutes of Health for
p.001413: a period not to exceed ten years; and
p.001413: (6) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
p.001413: and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such con- tracts and cooperative
p.001413: agreements with any public agency, or with any person, firm, association, corporation, or educational
p.001413: institution, as may be necessary to expedite and coordinate re- search relating to acquired immune deficiency syndrome.
p.001413: (b) PROJECTS FOR COOPERATION AMONG PUBLIC AND PRIVATE HEALTH ENTITIES.—In carrying out subsection (a), the
p.001413: Director of the Office shall establish projects to promote cooperation among Federal agencies, State,
p.001413: local, and regional public health agencies, and private entities, in research concerning the diagnosis,
p.001413: preven- tion, and treatment of acquired immune deficiency syndrome.
p.001413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001413:
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p.001419: individuals infected with the etiologic agent for acquired immune deficiency syndrome.
p.001419: SEC. 2403. ø300dd–2¿ REQUIREMENT OF SUBMISSION OF DESCRIPTION OF INTENDED USES OF GRANT.
p.001419: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001419: (1) the State submits to the Secretary a description of the purposes for which the State intends to expend such
p.001419: payments for the fiscal year;
p.001419: (2) such description provides information relating to the services and activities to be provided,
p.001419: including a description of the manner in which such services and activities will be co- ordinated with any similar
p.001419: services and activities of public and private entities; and
p.001419: (3) such description includes information relating to (A) the process for determining which eligible
p.001419: individuals are medically dependent or chronically dependent and (B) the proc- ess for establishing written plans
p.001419: of care for the provision of home and community-based health services under this part.
p.001419: SEC. 2404. ø300dd–3¿ RESTRICTIONS ON USE OF GRANT.
p.001419: (a) IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year to a
p.001419: State unless the State agrees that the payments will not be expended—
p.001419: (1) to provide for items or services described in section 2401(d)(3);
p.001419: (2) to make cash payments to intended recipients of serv- ices;
p.001419: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001419: or to purchase major medical equipment; or
p.001419: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001419: of Federal funds.
p.001419: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2401(a) for a fiscal
p.001419: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments made to the
p.001419: State under such sec- tion for administrative expenses with respect to carrying out the purpose of this part.
p.001419: (c) LIMITATION ON TOTAL PAYMENTS.—
p.001419: (1) Before March 1, 1989, for fiscal year 1989 and before September 1, 1989, for fiscal year 1990, the
p.001419: Secretary shall de-
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001419: Sec. 2405 PUBLIC HEALTH SERVICE ACT 1420
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p.001419: January 30, 2020
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p.001433: (6) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001433: the Secretary; and
p.001433:
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p.001433: (7) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001433: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001433: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 2501(a) for a
p.001433: fiscal year unless the State involved agrees that, in developing and carrying out the description required
p.001433: in subsection (a), the State will provide public notice with respect to the description (including any revisions) and
p.001433: will facilitate comments from interested persons.
p.001433: SEC. 2504. ø300ee–14¿ RESTRICTIONS ON USE OF GRANT.
p.001433: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless
p.001433: the State involved agrees that the payments will not be expended—
p.001433: (1) to provide inpatient services;
p.001433: (2) to make cash payments to intended recipients of serv- ices;
p.001433: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001433: or to purchase major medical equipment; or
p.001433: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001433: of Federal funds.
p.001433: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2501(a) for a fiscal
p.001433: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments for
p.001433: administrative expenses with respect to carrying out the purpose described in section 2501(b).
p.001433: SEC. 2505. ø300ee–15¿ REQUIREMENT OF REPORTS AND AUDITS BY STATES.
p.001433: (a) REPORTS.—The Secretary may not make payments under section 2501(a) for a fiscal year unless the State
p.001433: involved agrees to prepare and submit to the Secretary an annual report in such form and containing such information as
p.001433: the Secretary determines to be necessary for—
p.001433: (1) securing a record and a description of the purposes for which payments received by the State pursuant to such
p.001433: section were expended and of the recipients of such payments;
p.001433: (2) determining whether the payments were expended in accordance with the needs within the State required
p.001433: to be identified pursuant to section 2503(a)(2);
p.001433: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001433: Sec. 2506 PUBLIC HEALTH SERVICE ACT 1434
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p.001565: (E) EXCEPTIONS.—In developing the reporting require- ments under paragraph (1), the Secretary may provide for
p.001565: exceptions to such requirements for group health plans and health insurance issuers that substantially
p.001565: meet the goals of this section.
p.001565: (b) WELLNESS AND PREVENTION PROGRAMS.—For purposes of subsection (a)(1)(D), wellness and health promotion
p.001565: activities may include personalized wellness and prevention services, which are coordinated, maintained or
p.001565: delivered by a health care provider, a wellness and prevention plan manager, or a health, wellness or
p.001565: prevention services organization that conducts health risk assess- ments or offers ongoing face-to-face,
p.001565: telephonic or web-based inter- vention efforts for each of the program’s participants, and which may include
p.001565: the following wellness and prevention efforts:
p.001565: (1) Smoking cessation.
p.001565: (2) Weight management.
p.001565: (3) Stress management.
p.001565: (4) Physical fitness.
p.001565: (5) Nutrition.
p.001565: (6) Heart disease prevention.
p.001565: (7) Healthy lifestyle support.
p.001565: (8) Diabetes prevention.
p.001565: (c) PROTECTION OF SECOND AMENDMENT GUN RIGHTS.—
p.001565: (1) WELLNESS AND PREVENTION PROGRAMS.—A wellness and health promotion activity implemented under
p.001565: subsection (a)(1)(D) may not require the disclosure or collection of any in- formation relating to—
p.001565: (A) the presence or storage of a lawfully-possessed fire- arm or ammunition in the residence or on the property of an
p.001565: individual; or
p.001565: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001567: 1567
p.001567: PUBLIC HEALTH SERVICE ACT
p.001567: Sec. 2717
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p.001567: (B) the lawful use, possession, or storage of a firearm or ammunition by an individual.
p.001567: (2) LIMITATION ON DATA COLLECTION.—None of the authori- ties provided to the Secretary under the Patient Protection
p.001567: and Affordable Care Act or an amendment made by that Act shall be construed to authorize or may be
p.001567: used for the collection of any information relating to—
p.001567: (A) the lawful ownership or possession of a firearm or ammunition;
p.001567: (B) the lawful use of a firearm or ammunition; or
p.001567: (C) the lawful storage of a firearm or ammunition.
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p.001639: (ii) an assessment of the available workforce of the intermittent disaster response personnel described in
p.001639: subsection (c);
p.001639: (iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to
p.001639: simultaneously respond to multiple public health emergencies and the capacity to respond to a nation- wide
p.001639: public health emergency;
p.001639: (iv) the effectiveness of efforts to recruit, retain, and train such workforce; and
p.001639: (v) gaps that may exist in such workforce and rec- ommendations for addressing such gaps.
p.001639: (B) UPDATES.—As part of the National Health Security Strategy under section 2802, the Secretary shall update the
p.001639: findings from the review under subparagraph (A) and provide recommendations to modify the policies of the Na-
p.001639: tional Disaster Medical System as necessary.
p.001639: (3) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI- TIES.—In carrying out paragraph (1), the Secretary shall
p.001639: estab- lish criteria regarding the participation of States and private entities in the National Disaster
p.001639: Medical System, including cri- teria regarding agreements for such participation. The criteria shall include the
p.001639: following:
p.001639: (A) Provisions relating to the custody and use of Fed- eral personal property by such entities, which
p.001639: may in the
p.001639: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001641: PUBLIC HEALTH SERVICE ACT
p.001641: Sec. 2812
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p.001641: January 30, 2020
p.001641: discretion of the Secretary include authorizing the custody and use of such property to respond to emergency
p.001641: situa- tions for which the National Disaster Medical System has not been activated by the Secretary pursuant to
p.001641: subsection (a)(3)(A). Any such custody and use of Federal personal property shall be on a reimbursable basis.
p.001641: (B) Provisions relating to circumstances in which an individual or entity has agreements with both the National
p.001641: Disaster Medical System and another entity regarding the provision of emergency services by the individual. Such
p.001641: provisions shall address the issue of priorities among the agreements involved.
p.001641: (c) INTERMITTENT DISASTER-RESPONSE PERSONNEL.—
p.001641: (1) IN GENERAL.—For the purpose of assisting the National Disaster Medical System in carrying out duties under this
p.001641: sec- tion, the Secretary may appoint individuals to serve as inter- mittent personnel of such System in
p.001641: accordance with applica- ble civil service laws and regulations.
p.001641: (2) LIABILITY.—For purposes of section 224(a) and the rem- edies described in such section, an individual appointed
p.001641: under paragraph (1) shall, while acting within the scope of such ap- pointment, be considered to be an
p.001641: employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to
p.001641: the participation of individuals ap- pointed under paragraph (1) in training programs authorized by the
p.001641: Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified
p.001641: in sub- section (a)(2)(B), acts of individuals so appointed that are with- in the scope of such participation
p.001641: shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the
p.001641: individuals receive compensation for such par- ticipation).
p.001641: (3) NOTIFICATION.—Not later than 30 days after the date on which the Secretary determines the number of
...

p.001653: laboratory, a physician (as defined in section
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001653: Sec. 3000 PUBLIC HEALTH SERVICE ACT 1654
p.001653:
p.001653: 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security
p.001653: Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in
p.001653: the Indian Self-Determina- tion and Education Assistance Act), tribal organization, or urban Indian
p.001653: organization (as defined in section 4 of the In- dian Health Care Improvement Act), a rural health
p.001653: clinic, a covered entity under section 340B, an ambulatory surgical cen- ter described in section 1833(i) of the
p.001653: Social Security Act, a therapist (as defined in section 1848(k)(3)(B)(iii) of the Social Security Act),
p.001653: and any other category of health care facility, entity, practitioner, or clinician determined appropriate by the
p.001653: Secretary.
p.001653: (4) HEALTH INFORMATION.—The term ‘‘health information’’ has the meaning given such term in section 1171(4) of
p.001653: the So- cial Security Act.
p.001653: (5) HEALTH INFORMATION TECHNOLOGY.—The term ‘‘health information technology’’ means hardware, software,
p.001653: integrated technologies or related licenses, intellectual property, up- grades, or packaged solutions
p.001653: sold as services that are de- signed for or support the use by health care entities or patients for the electronic
p.001653: creation, maintenance, access, or exchange of health information
p.001653: (6) HEALTH PLAN.—The term ‘‘health plan’’ has the mean- ing given such term in section 1171(5) of the
p.001653: Social Security Act.
p.001653: (7) HIT ADVISORY COMMITTEE.—The term ‘‘HIT Advisory Committee’’ means such Committee established under
p.001653: section 3002(a).
p.001653: (8) 1 INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION.— The term ‘‘individually identifiable health information’’
p.001653: has the meaning given such term in section 1171(6) of the Social Secu- rity Act.
p.001653: (9) 1 INTEROPERABILITY.—The term ‘‘interoperability’’, with respect to health information technology, means
p.001653: such health information technology that—
p.001653: (A) enables the secure exchange of electronic health information with, and use of electronic health information
p.001653: from, other health information technology without special effort on the part of the user;
p.001653: (B) allows for complete access, exchange, and use of all electronically accessible health information for
p.001653: authorized use under applicable State or Federal law; and
p.001653: (C) does not constitute information blocking as defined in section 3022(a).
p.001653: (10) 1 LABORATORY.—The term ‘‘laboratory’’ has the mean- ing given such term in section 353(a).
p.001653: (11) 1 NATIONAL COORDINATOR.—The term ‘‘National Coor- dinator’’ means the head of the Office of the
p.001653: National Coordi-
p.001653:
p.001653:
p.001653:
p.001653:
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p.001653: January 30, 2020
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p.001661: and common agreement under this para- graph.
p.001661: (iii) PILOT TESTING.—The National Coordinator, in consultation with the National Institute of Standards and
p.001661: Technology, shall provide for the pilot testing of the trusted exchange framework and common agree- ment
p.001661: established or supported under this subsection (as authorized under section 13201 of the Health In-
p.001661: formation Technology for Economic and Clinical Health Act). The National Coordinator, in consultation
p.001661: with the National Institute of Standards and Tech- nology, may delegate pilot testing activities under this
p.001661: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001661:
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p.001661: Sec. 3001 PUBLIC HEALTH SERVICE ACT 1662
p.001661:
p.001661: clause to independent entities with appropriate exper- tise.
p.001661: (C) PUBLICATION OF A TRUSTED EXCHANGE FRAMEWORK AND COMMON AGREEMENT.—Not later than 1 year after
p.001661: convening stakeholders under subparagraph (A), the Na- tional Coordinator shall publish on its public
p.001661: Internet website, and in the Federal register, the trusted exchange framework and common agreement developed or
p.001661: supported under subparagraph (B). Such trusted exchange frame- work and common agreement shall be published in a
p.001661: man- ner that protects proprietary and security information, in- cluding trade secrets and any other protected
p.001661: intellectual property.
p.001661: (D) DIRECTORY OF PARTICIPATING HEALTH INFORMA- TION NETWORKS.—
p.001661: (i) IN GENERAL.—Not later than 2 years after con- vening stakeholders under subparagraph (A), and an- nually
p.001661: thereafter, the National Coordinator shall pub- lish on its public Internet website a list of the health
p.001661: information networks that have adopted the common agreement and are capable of trusted exchange pursu- ant to
p.001661: the common agreement developed or supported under paragraph (B).
p.001661: (ii) PROCESS.—The Secretary shall, through notice and comment rulemaking, establish a process for health
p.001661: information networks that voluntarily elect to adopt the trusted exchange framework and common agreement to
p.001661: attest to such adoption of the framework and agreement.
p.001661: (E) APPLICATION OF THE TRUSTED EXCHANGE FRAME- WORK AND COMMON AGREEMENT.—As appropriate, Federal
p.001661: agencies contracting or entering into agreements with health information exchange networks may require that
p.001661: as each such network upgrades health information technology or trust and operational practices, such
p.001661: network may adopt, where available, the trusted exchange framework and common agreement published under
p.001661: subparagraph (C).
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p.001661: (F) RULE OF CONSTRUCTION.—
p.001661: (i) GENERAL ADOPTION.—Nothing in this para- graph shall be construed to require a health informa-
p.001661: tion network to adopt the trusted exchange framework or common agreement.
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p.000017: 3509, to determine if the collections are being conducted in accordance with the minimum sets of data and the
p.000017: standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be
p.000017: in conformance, by taking such action as may be necessary to assure that the collection will conform to
p.000017: such sets of data and standards not later than the nineteenth day after the date of the completion of the review of the
p.000017: collec- tion.
p.000017: (k)(1) There is established in the Office of the Secretary a com- mittee to be known as the National Committee on Vital
p.000017: and Health Statistics (hereinafter in this subsection, referred to as the ‘‘Com- mittee’’) which shall consist
p.000017: of 18 members.
p.000017: (2) The members of the Committee shall be appointed from among persons who have distinguished themselves
p.000017: in the fields of health statistics, electronic interchange of health care information, privacy and security of
p.000017: electronic information, population-based public health, purchasing or financing health care services, inte-
p.000017: grated computerized health information systems, health services research, consumer interests in health
p.000017: information, health data standards, epidemiology, and the provision of health services. Members of the
p.000017: Committee shall be appointed for terms of 4 years.
p.000017: (3) Of the members of the Committee—
p.000017: (A) 1 shall be appointed, not later than 60 days after the date of the enactment of the Health Insurance
p.000017: Portability and Accountability Act of 1996, by the Speaker of the House of Representatives after consultation
p.000017: with the Minority Leader of the House of Representatives;
p.000017: (B) 1 shall be appointed, not later than 60 days after the date of the enactment of the Health Insurance
p.000017: Portability and Accountability Act of 1996, by the President pro tempore of the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 83 PUBLIC HEALTH SERVICE ACT Sec. 306
p.000017:
p.000017: Senate after consultation with the Minority Leader of the Sen- ate; and
p.000017: (C) 16 shall be appointed by the Secretary.
p.000017: (4) Members of the Committee shall be compensated in accord- ance with section 208(c).
p.000017: (5) The Committee—
p.000017: (A) shall assist and advise the Secretary—
p.000017: (i) to delineate statistical problems bearing on health and health services which are of national or
p.000017: international interest;
p.000017: (ii) to stimulate studies of such problems by other or- ganizations and agencies whenever possible or to make
p.000017: in- vestigations of such problems through subcommittees;
p.000017: (iii) to determine, approve, and revise the terms, defi- nitions, classifications, and guidelines for assessing health
p.000017: status and health services, their distribution and costs, for use (I) within the Department of Health and Human Serv-
p.000017: ices, (II) by all programs administered or funded by the Secretary, including the Federal-State-local
p.000017: cooperative health statistics system referred to in subsection (e), and
p.000017: (III) to the extent possible as determined by the head of the agency involved, by the Department of
p.000017: Veterans Af- fairs, the Department of Defense, and other Federal agen- cies concerned with health and health services;
p.000017: (iv) with respect to the design of and approval of health statistical and health information systems
p.000017: con- cerned with the collection, processing, and tabulation of health statistics within the Department of
p.000017: Health and Human Services, with respect to the Cooperative Health Statistics System established under
p.000017: subsection (e), and with respect to the standardized means for the collection of health information and
p.000017: statistics to be established by the Secretary under subsection (j)(1);
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p.000113: January 30, 2020
p.000113: PREVENTIVE HEALTH MEASURES WITH RESPECT TO PROSTATE CANCER
p.000113: SEC. 317D. ø247b–5¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000113: Control and Pre- vention, may make grants to States and local health departments for the purpose of
p.000113: enabling such States and departments to carry out programs that may include the following:
p.000113: (1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners
p.000113: regarding screening for prostate cancer.
p.000113: (2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National
p.000113: Institutes of Health, the effectiveness of screening strategies for prostate cancer.
p.000113: (3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the
p.000113: quality of life for men after prostrate cancer screening and followup.
p.000113: (4) To develop and disseminate public information and education programs for prostate cancer, including
p.000113: appropriate messages about the risks and benefits of prostate cancer screening for the general
p.000113: public, health care providers, policy makers and other appropriate individuals.
p.000113: (5) To improve surveillance for prostate cancer.
p.000113: (6) To address the needs of underserved and minority pop- ulations regarding prostate cancer.
p.000113: (7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Pre-
p.000113: ventive Services Task Force and shall seek input, where appro- priate, from professional societies and other private
p.000113: and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
p.000113: (A) to screen men for prostate cancer as a preventive health measure;
p.000113: (B) to provide appropriate referrals for the medical treatment of men who have been screened under subpara-
p.000113: graph (A) and to ensure, to the extent practicable, the pro- vision of appropriate followup services and support
p.000113: serv- ices such as case management;
p.000113: (C) to establish mechanisms through which State and local health departments can monitor the quality
p.000113: of screening procedures for prostate cancer, including the in- terpretation of such procedures; and
p.000113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000113: Sec. 317D PUBLIC HEALTH SERVICE ACT 114
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p.000449: (J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement
p.000449: and al- location,
p.000449: (K) work actively to increase the supply of donated organs,
p.000449: (L) submit to the Secretary an annual report containing in- formation on the comparative costs and patient
p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000449:
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
p.000449:
p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
p.000449: (1) receiving from interested persons critical comments re- lating to the manner in which the Organ Procurement
...

p.000459: Based on such examination, the Secretary shall require that the standards used by the accreditation entities
p.000459: recognized under sub- section (b) ensure that a cord blood unit is acquired with the in- formed consent of
p.000459: the maternal donor.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000459:
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p.000459: Sec. 379 PUBLIC HEALTH SERVICE ACT 460
p.000459:
p.000459: (d) FUNCTIONS.— 84
p.000459: (1) BONE MARROW FUNCTIONS.—With respect to bone mar- row, the Program shall—
p.000459: (A) operate a system for identifying, matching, and fa- cilitating the distribution of bone marrow that is
p.000459: suitably matched to candidate patients;
p.000459: (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care
p.000459: professionals, and patients to search by means of electronic access all available bone marrow donors listed in
p.000459: the Program;
p.000459: (C) carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including
p.000459: with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed
p.000459: ances- try) in the enrollment of the Program;
p.000459: (D) maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000459: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000459: January 30, 2020
p.000459:
p.000459: ‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
p.000459: ‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller General of the
p.000459: United States shall conduct a study of the National Bone Marrow Donor Registry under section 379 of the Public
p.000459: Health Service Act for purposes of making determinations of the following:
...

p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
p.000591:
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000591:
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: January 30, 2020
p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
p.000593: (1) IN GENERAL.—The Secretary, in consultation with the Director of the Centers for Disease Control and
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p.000597: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–359)
p.000597: amended subparagraph (H) to read as provided above, there- by indicating the intent of the Congress to change the
p.000597: designation of the Institute. (The former designation was the National Institute of Dental Research.) Conforming
p.000597: changes were not, how- ever, made to section 453 or the related subpart heading, or to the reference in section
p.000597: 409A(a).
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000599: PUBLIC HEALTH SERVICE ACT
p.000599: Sec. 401
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p.000599: January 30, 2020
p.000599: (23) The National Center for Complementary and Integra- tive Health.
p.000599: (24) The National Institute on Minority Health and Health Disparities.
p.000599: (25) Any other national center that, as an agency separate from any national research institute, was established
p.000599: within the National Institutes of Health as of the day before the date of the enactment of the National
p.000599: Institutes of Health Reform Act of 2006.
p.000599: (c) DIVISION OF PROGRAM COORDINATION, PLANNING, AND STRA-
p.000599: TEGIC INITIATIVES.—
p.000599: (1) IN GENERAL.—Within the Office of the Director of the National Institutes of Health, there shall be a
p.000599: Division of Pro- gram Coordination, Planning, and Strategic Initiatives (re- ferred to in this subsection
p.000599: as the ‘‘Division’’).
p.000599: (2) OFFICES WITHIN DIVISION.—
p.000599: (A) OFFICES.—The following offices are within the Di- vision: The Office of AIDS Research, the Office of
p.000599: Research on Women’s Health, the Office of Behavioral and Social Sciences Research, the Office of Disease
p.000599: Prevention, the Office of Dietary Supplements, and any other office located within the Office of the Director of
p.000599: NIH as of the day be- fore the date of the enactment of the National Institutes of Health Reform Act
p.000599: of 2006. In addition to such offices, the Director of NIH may establish within the Division such additional
p.000599: offices or other administrative units as the Di- rector determines to be appropriate.
p.000599: (B) AUTHORITIES.—Each office in the Division—
p.000599: (i) shall continue to carry out the authorities that were in effect for the office before the date of enact-
p.000599: ment referred to in subparagraph (A); and
p.000599: (ii) shall, as determined appropriate by the Direc- tor of NIH, support the Division with respect to the
...

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p.000605: January 30, 2020
p.000605: respecting the management and operation of programs and ac- tivities within the National Institutes of Health;
p.000605: (2) shall coordinate and oversee the operation of the na- tional research institutes, national centers, and
p.000605: administrative entities within the National Institutes of Health;
p.000605: (3) shall, in consultation with the heads of the national re- search institutes and national centers, be
p.000605: responsible for pro- gram coordination across the national research institutes and national centers, including
p.000605: conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is
p.000605: balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
p.000605: (4) shall assemble accurate data to be used to assess re- search priorities, including—
p.000605: (A) information to better evaluate scientific oppor- tunity, public health burdens, and progress in
p.000605: reducing health disparities; and
p.000605: (B) data on study populations of clinical research, funded by or conducted at each national research institute
p.000605: and national center, which—
p.000605: (i) specifies the inclusion of—
p.000605: (I) women;
p.000605: (II) members of minority groups;
p.000605: (III) relevant age categories, including pedi- atric subgroups; and
p.000605: (IV) other demographic variables as the Direc- tor of the National Institutes of Health determines appropriate;
p.000605: (ii) is disaggregated by research area, condition, and disease categories; and
p.000605: (iii) is to be made publicly available on the Inter- net website of the National Institutes of Health;
p.000605: (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as
p.000605: determined by the agencies of the National Institutes of Health, and through the development,
p.000605: implementation, and updating of the strategic plan developed under subsection (m);
p.000605: (6) shall ensure that the resources of the National Insti- tutes of Health are sufficiently allocated
p.000605: for research projects identified in strategic plans;
p.000605: (7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
p.000605: (i) identify research that represents important areas of emerging scientific opportunities, rising public health chal-
p.000605: lenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting
p.000605: addi- tional research that involves collaboration between 2 or more national research institutes or
p.000605: national centers, or would otherwise benefit from strategic coordination and planning;
p.000605: (ii) include information on such research in reports under section 403; and
p.000605: (iii) in the case of such research supported with funds referred to in subparagraph (B)—
p.000605: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000605:
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p.000635: degrees awarded during the period in which the programs received funding under this title;
p.000635: (III) investigator-initiated awards for postdoctoral training and postdoctoral training funded
p.000635: through research grants;
p.000635: (IV) a breakdown by demographic variables and other appropriate categories; and
p.000635: (V) an evaluation and comparison of outcomes and effectiveness of various training programs.
p.000635: (v) Clinical trials, including a breakdown of par- ticipation by study populations and demographic vari- ables,
p.000635: including relevant age categories (such as pedi- atric subgroups), information submitted by each na- tional
p.000635: research institute and national center to the Di- rector of National Institutes of Health under section 492B(f),
p.000635: and such other information as may be nec- essary to demonstrate compliance with section 492B and other
p.000635: applicable requirements regarding inclusion of demographic groups.
p.000635: (vi) Translational research activities with other agencies of the Public Health Service.
p.000635: (5) A summary of the research activities throughout the agencies, which summary shall be organized by
p.000635: the following categories, where applicable:
p.000635: (A) Cancer.
p.000635: (B) Neurosciences.
p.000635: (C) Life stages, human development, and rehabilita- tion.
p.000635: (D) Organ systems.
p.000635: (E) Autoimmune diseases.
p.000635: (F) Genomics.
p.000635: (G) Molecular biology and basic science.
p.000635: (H) Technology development.
p.000635: (I) Chronic diseases, including pain and palliative care.
p.000635: (J) Infectious diseases and bioterrorism.
p.000635: (K) Minority health and health disparities.
p.000635: (L) Such additional categories as the Director deter- mines to be appropriate.
p.000635: (6) A review of each entity receiving funding under this title in its capacity as a center of excellence (in
p.000635: this paragraph referred to as a ‘‘center of excellence’’), including the fol- lowing—
p.000635: (A) an evaluation of the performance and research out- comes of each center of excellence; and
p.000635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000635:
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p.000635: Sec. 403A PUBLIC HEALTH SERVICE ACT 636
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p.000635:
p.000635: (B) recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence.
p.000635: (b) REQUIREMENT REGARDING DISEASE-SPECIFIC RESEARCH AC- TIVITIES.—In a report under subsection (a), the
...

p.000655: focused on promoting and providing opportunities for new researchers and earlier re- search independence.
p.000655: (b) ACTIVITIES.—The Director of the National Institutes of Health, through the Initiative shall—
p.000655: (1) promote policies and programs within the National In- stitutes of Health that are focused on improving
p.000655: opportunities for new researchers and promoting earlier research independ- ence, including existing policies and
p.000655: programs, as appropriate;
p.000655: (2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote
p.000655: opportunities for new researchers and earlier research independence, such as policies to increase opportunities
p.000655: for new researchers to receive funding, enhance training and mentorship programs for re- searchers, and enhance
p.000655: workforce diversity;
p.000655: (3) coordinate, as appropriate, with relevant agencies, pro- fessional and academic associations, academic
p.000655: institutions, and others, to improve and update existing information on the bio- medical research workforce in order to
p.000655: inform programs related to the training, recruitment, and retention of biomedical re- searchers; and
p.000655: (4) carry out other activities, including evaluation and oversight of existing programs, as appropriate,
p.000655: to promote the development of the next generation of researchers and earlier research independence.
p.000655: SEC. 404N. ø283p¿ POPULATION FOCUSED RESEARCH.
p.000655: The Director of the National Institutes of Health shall, as ap- propriate, encourage efforts to improve
p.000655: research related to the health of sexual and gender minority populations, including by—
p.000655: (1) facilitating increased participation of sexual and gender minority populations in clinical research supported by
p.000655: the Na- tional Institutes of Health, and reporting on such participation, as applicable;
p.000655: (2) facilitating the development of valid and reliable meth- ods for research relevant to sexual and gender
p.000655: minority popu- lations; and
p.000655: (3) addressing methodological challenges.
p.000655: PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000655: APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH INSTITUTES
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p.000655: January 30, 2020
p.000655: SEC. 405. ø284¿
p.000655: (a) APPOINTMENT.—
p.000655: (1) IN GENERAL.—The Director of the National Cancer In- stitute shall be appointed by the President, and
p.000655: the Directors of the other national research institutes and national centers shall be appointed by the
p.000655: Secretary, acting through the Direc- tor of National Institutes of Health. Each Director of a national research
p.000655: institute or national center shall report directly to the Director of National Institutes of Health.
p.000655: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000657: PUBLIC HEALTH SERVICE ACT
p.000657: Sec. 405
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p.000685: and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000685: respon- sibilities that are related to breast cancer and other cancers of the reproductive system of women.
p.000685: (c) PROGRAMS FOR BREAST CANCER.—
p.000685: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000685: expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection
p.000685: shall provide for an expansion and intensification of the conduct and support of—
p.000685: (A) basic research concerning the etiology and causes of breast cancer;
p.000685: (B) clinical research and related activities concerning the causes, prevention, detection and treatment of
p.000685: breast cancer;
p.000685: (C) control programs with respect to breast cancer in accordance with section 412, including
p.000685: community-based programs designed to assist women who are members of
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000685:
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p.000685: Sec. 417 PUBLIC HEALTH SERVICE ACT 686
p.000685:
p.000685: medically underserved populations, low-income popu- lations, or minority groups;
p.000685: (D) information and education programs with respect to breast cancer in accordance with section 413; and
p.000685: (E) research and demonstration centers with respect to breast cancer in accordance with section 414, including the
p.000685: development and operation of centers for breast cancer re- search to bring together basic and clinical, biomedical and
p.000685: behavioral scientists to conduct basic, clinical, epidemiolog- ical, psychosocial, prevention and treatment
p.000685: research and related activities on breast cancer.
p.000685: Not less than six centers shall be operated under subpara- graph (E). Activities of such centers should
p.000685: include supporting new and innovative research and training programs for new re- searchers. Such centers shall give
p.000685: priority to expediting the transfer of research advances to clinical applications.
p.000685: (2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—
p.000685: (A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are imple-
p.000685: mented in accordance with a plan for the programs. Such plan shall include comments and recommendations
p.000685: that the Director of the Institute considers appropriate, with due consideration provided to the
p.000685: professional judgment needs of the Institute as expressed in the annual budget estimate prepared in
p.000685: accordance with section 413(9) 16. The Director of the Institute, in consultation with the National Cancer Advisory
p.000685: Board, shall periodically review and re- vise such plan.
p.000685: (B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President’s
p.000685: Cancer Panel, the Secretary and the Director of NIH.
...

p.000691: (vi) location of primary tumor coded;
p.000691: (vii) histologic diagnosis;
p.000691: (viii) tumor marker data when available;
p.000691: (ix) treatment and outcome data;
p.000691: (x) information related to specimen quality; and
p.000691: (xi) any other applicable information required by the Secretary.
p.000691: (b) IMPROVING CARE FOR PEDIATRIC CANCER SURVIVORS.—
p.000691: (1) RESEARCH ON PEDIATRIC CANCER SURVIVORSHIP.—The Director of NIH, in coordination with ongoing
p.000691: research activi- ties, may continue to conduct or support pediatric cancer survi- vorship research including in any of
p.000691: the following areas:
p.000691: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000693: 693
p.000693: PUBLIC HEALTH SERVICE ACT
p.000693: Sec. 417F
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p.000693: (A) Outcomes of pediatric cancer survivors, including within minority or other medically underserved
p.000693: popu- lations and with respect to health disparities of such out- comes.
p.000693: (B) Barriers to follow-up care for pediatric cancer sur- vivors, including within minority or other medically under-
p.000693: served populations.
p.000693: (C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on
p.000693: treatment outcomes and survivorship.
p.000693: (D) The development of indicators used for long-term follow-up and analysis of the late effects of
p.000693: cancer treat- ment for pediatric cancer survivors.
p.000693: (E) The identification of, as applicable—
p.000693: (i) risk factors associated with the late effects of cancer treatment;
p.000693: (ii) predictors of adverse neurocognitive and psy- chosocial outcomes; and
p.000693: (iii) the molecular basis of long-term complica- tions.
p.000693: (F) The development of targeted interventions to re- duce the burden of morbidity borne by cancer survivors in
p.000693: order to protect such cancer survivors from the late effects of cancer.
p.000693: (2) BALANCED APPROACH.—In conducting or supporting re- search under paragraph (1)(A)(i) on pediatric cancer
p.000693: survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such
p.000693: research addresses both the physical and the psychological needs of such sur- vivors, as appropriate.
p.000693: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as being inconsistent with the goals and
p.000693: purposes of the Minority Health and Health Disparities Research and Education Act of 2000.
p.000693: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section and section 399E–1, there
p.000693: are authorized to be appropriated $30,000,000 for each of fiscal years 2019 through 2023. Funds
p.000693: appropriated under this subsection shall remain avail- able until expended.
p.000693: SEC. 417F. ø42 U.S.C. 285a–12¿ INTERAGENCY BREAST CANCER AND EN- VIRONMENTAL RESEARCH COORDINATING COMMITTEE.
p.000693: (a) INTERAGENCY BREAST CANCER AND ENVIRONMENTAL RE-
p.000693: SEARCH COORDINATING COMMITTEE.—
p.000693: (1) ESTABLISHMENT.—Not later than 6 months after the date of the enactment of this section, the Secretary shall
p.000693: estab- lish a committee, to be known as the Interagency Breast Can- cer and Environmental Research Coordinating
p.000693: Committee (in this section referred to as the ‘‘Committee’’).
p.000693: (2) DUTIES.—The Committee shall—
p.000693: (A) share and coordinate information on existing re- search activities, and make recommendations to the
p.000693: Na- tional Institutes of Health and other Federal agencies re- garding how to improve existing research
p.000693: programs, that are related to breast cancer research;
p.000693: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000705: research and re- lated activities of the Institute with respect to heart attack, stroke, and other cardiovascular
p.000705: diseases in women.
p.000705: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate activities under
p.000705: subsection (a) with similar activities conducted by the other national research insti- tutes and agencies
p.000705: of the National Institutes of Health to the ex- tent that such Institutes and agencies have
p.000705: responsibilities that are related to heart attack, stroke, and other cardiovascular dis- eases in women.
p.000705: (c) CERTAIN PROGRAMS.—In carrying out subsection (a), the Di- rector of the Institute shall conduct or support research
p.000705: to expand the understanding of the causes of, and to develop methods for pre- venting, cardiovascular diseases in
p.000705: women. Activities under such subsection shall include conducting and supporting the following:
p.000705: (1) Research to determine the reasons underlying the prev- alence of heart attack, stroke, and other
p.000705: cardiovascular dis- eases in women, including African-American women and other women who are members of racial
p.000705: or ethnic minority groups.
p.000705: (2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
p.000705: (3) Epidemiological studies to address the frequency and natural history of such diseases and the
p.000705: differences among men and women, and among racial and ethnic groups, with re- spect to such diseases.
p.000705: (4) The development of safe, efficient, and cost-effective di- agnostic approaches to evaluating women with
p.000705: suspected ischemic heart disease.
p.000705: (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
p.000705: (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women,
p.000705: including appli- cations of effective methods for the control of blood pressure, lipids, and obesity.
p.000705: (7) Information and education programs for patients and health care providers on risk factors associated
p.000705: with heart at- tack, stroke, and other cardiovascular diseases in women, and on the importance of the
p.000705: prevention or control of such risk fac-
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
...

p.000705: research with respect to—
p.000705: (1) causation of congenital heart disease, including genetic causes;
p.000705: (2) long-term outcomes in individuals with congenital heart disease, including infants, children,
p.000705: teenagers, adults, and elderly individuals;
p.000705: (3) diagnosis, treatment, and prevention;
p.000705:
p.000705:
p.000705:
p.000705:
p.000705: January 30, 2020
p.000705: 22 So in law. The section designation lacks a period. See section 521 of Public Law 106–310 (114 Stat.
p.000705: 1116).
p.000705: 23 Section 425 was repealed by section 103(b)(20) of Public Law 109–482 (120 Stat. 3688).
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
p.000705:
p.000705:
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p.000707: PUBLIC HEALTH SERVICE ACT
p.000707: Sec. 427
p.000707:
p.000707: (4) studies using longitudinal data and retrospective anal- ysis to identify effective treatments and outcomes
p.000707: for individ- uals with congenital heart disease; and
p.000707: (5) identifying barriers to life-long care for individuals with congenital heart disease.
p.000707: (b) COORDINATION OF RESEARCH ACTIVITIES.—The Director of the Institute may coordinate research efforts
p.000707: related to congenital heart disease among multiple research institutions and may de- velop research networks.
p.000707: (c) MINORITY AND MEDICALLY UNDERSERVED COMMUNITIES.— In carrying out the activities described in this section,
p.000707: the Director of the Institute shall consider the application of such research and other activities to minority and
p.000707: medically underserved commu- nities.
p.000707: Subpart 3—National Institute of Diabetes and Digestive and Kidney Diseases
p.000707: PURPOSE OF THE INSTITUTE
p.000707: SEC. 426. ø285c¿ The general purpose of the National Institute of Diabetes and Digestive and Kidney Diseases
p.000707: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of research,
p.000707: training, health information dissemination, and other programs with respect to diabetes mellitus and endocrine and
p.000707: met- abolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic
p.000707: diseases.
p.000707:
p.000707:
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p.000707:
p.000707: January 30, 2020
p.000707:
p.000707: DATA SYSTEMS AND INFORMATION CLEARINGHOUSES
p.000707: SEC. 427. ø285c–1¿ (a) The Director of the Institute shall (1) establish the National Diabetes Data
p.000707: System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations
p.000707: with diabetes, including, where possible, data involving general populations for the purpose of detection
p.000707: of indi- viduals with a risk of developing diabetes, and (2) establish the Na- tional Diabetes Information
p.000707: Clearinghouse to facilitate and en- hance knowledge and understanding of diabetes on the part of health
p.000707: professionals, patients, and the public through the effective dissemination of information.
...

p.000723: in dealing with, and all Americans in understanding, the problems and processes associated with growing older.
p.000723: (d) The Director of the Institute shall make grants to public and private nonprofit institutions to
p.000723: conduct research relating to Alzheimer’s Disease.
p.000723: ALZHEIMER’S DISEASE CENTERS
p.000723: SEC. 445. ø285e–2¿ (a)(1) The Director of the Institute may enter into cooperative agreements with and
p.000723: make grants to public or private nonprofit entities (including university medical centers) to pay all or part
p.000723: of the cost of planning, establishing, or strength- ening, and providing basic operating support (including staffing)
p.000723: for centers for basic and clinical research (including multidisciplinary research) into, training in, and
p.000723: demonstration of advanced diag- nostic, prevention, and treatment methods for Alzheimer’s disease.
p.000723: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000723: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000723: (b)(1) Federal payments made under a cooperative agreement or grant under subsection (a) may, with respect to
p.000723: Alzheimer’s dis- ease, be used for—
p.000723: (A) diagnostic examinations, patient assessments, patient care costs, and other costs necessary for
p.000723: conducting research;
p.000723: (B) training, including training for allied health profes- sionals;
p.000723: (C) diagnostic and treatment clinics designed to meet the special needs of minority and rural populations
p.000723: and other un- derserved populations;
p.000723: (D) activities to educate the public; and
p.000723: (E) the dissemination of information.
p.000723: (2) For purposes of paragraph (1), the term ‘‘training’’ does not include research training for which
p.000723: National Research Service Awards 26 may be provided under section 487.
p.000723: (c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be
p.000723: extended by the Di- rector for additional periods of not more than five years each if the operations of such center
p.000723: have been reviewed by an appropriate technical and scientific peer review group established by the Direc- tor and
p.000723: if such group has recommended to the Director that such period should be extended.
p.000723:
p.000723:
p.000723:
p.000723:
p.000723: January 30, 2020
p.000723: 26 Now Ruth L. Kirschstein National Research Service Awards. See section 487.
p.000723: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000723:
p.000723:
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p.000723: Sec. 445A PUBLIC HEALTH SERVICE ACT 724
p.000723:
p.000723: CLAUDE D. PEPPER OLDER AMERICANS INDEPENDENCE CENTERS
p.000723: SEC. 445A. ø285e–3¿ (a) The Director of the Institute shall enter into cooperative agreements with, and make
p.000723: grants to, public and private nonprofit entities for the development or expansion of not less than 10
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p.000753: 753
p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
p.000753: (C) study the effects of discrimination on institutions and individuals, including majority institutions
p.000753: and indi- viduals;
p.000753: (D) support and develop research designed to elimi- nate institutional discrimination; and
p.000753: (E) provide increased emphasis on the concerns of women and minority populations in training programs,
p.000753: service delivery programs, and research endeavors of the Institute.
p.000753: ASSOCIATE DIRECTOR FOR PREVENTION
p.000753: SEC. 464S. ø285p–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000753: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000753: concerning the prevention of mental disorder. The Associate Director shall be appointed by the Director
p.000753: of the Insti- tute from individuals who because of their professional training or expertise are experts in mental
p.000753: disorder and the prevention of such.
p.000753: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000753: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000753: and resources allocated to those activities.
p.000753:
p.000753:
p.000753:
p.000753:
p.000753:
p.000753: January 30, 2020
p.000753: OFFICE OF RURAL MENTAL HEALTH RESEARCH
p.000753: SEC. 464T. ø285p–2¿ (a) IN GENERAL.—There is established within the Institute an office to be known as
p.000753: the Office of Rural
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000753:
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p.000753:
p.000753: Sec. 464U PUBLIC HEALTH SERVICE ACT 754
p.000753:
p.000753: Mental Health Research (hereafter in this section referred to as the ‘‘Office’’). The Office shall be headed by a
...

p.000759: including the mapping and sequencing of indi- vidual genes. Such purpose includes—
p.000759: (1) planning and coordinating the research goal of the ge- nome project;
p.000759: (2) reviewing and funding research proposals;
p.000759: (3) developing training programs;
p.000759: (4) coordinating international genome research;
p.000759: (5) communicating advances in genome science to the pub- lic; and
p.000759: (6) reviewing and funding proposals to address the ethical and legal issues associated with the genome project
p.000759: (including legal issues regarding patents).
p.000759: (b) The Director of the Institute may conduct and support re- search training—
p.000759: (1) for which fellowship support is not provided under sec- tion 487; and
p.000759: (2) that is not residency training of physicians or other health professionals.
p.000759: (c)(1) Except as provided in paragraph (2), of the amounts ap- propriated to carry out subsection (a) for a fiscal
p.000759: year, the Director of the Institute shall make available not less than 5 percent for carrying out paragraph
p.000759: (6) of such subsection.
p.000759: (2) With respect to providing funds under subsection (a)(6) for proposals to address the ethical issues
p.000759: associated with the genome project, paragraph (1) shall not apply for a fiscal year if the Direc- tor of the Institute
p.000759: certifies to the Committee on Energy and Com- merce of the House of Representatives, and to the Committee on
p.000759: Labor and Human Resources of the Senate, that the Director has determined that an insufficient number of such
p.000759: proposals meet the applicable requirements of sections 491 and 492.
p.000759: Subpart 20—National Institute on Minority Health and Health Disparities
p.000759: SEC. 464z–3. ø285t¿ PURPOSE OF CENTER 47.
p.000759: (a) IN GENERAL.—The general purpose of the National Insti- tute on Minority Health and Health Disparities (in
p.000759: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of research, training, dissemination of
p.000759: information, and other programs with re- spect to minority health conditions and other populations with health
p.000759: disparities.
p.000759:
p.000759:
p.000759:
p.000759:
p.000759:
p.000759:
p.000759: January 30, 2020
p.000759: 46 The word ‘‘CENTER’’ in the section heading probably should read ‘‘INSTITUTE’’. Section 101(c)(4)(C) of
p.000759: Public Law 109–482 (120 Stat. 3675) struck ‘‘center’’ each place such term ap- peared in this subpart and
p.000759: inserted ‘‘institute’’. However, this amendment was not effective with respect to the section heading because the word
p.000759: ‘‘CENTER’’ appears in small caps.
p.000759: 47 The word ‘‘CENTER’’ in the section heading for section 464z–3 probably should read ‘‘IN- STITUTE’’. See
p.000759: amendment made by section 10334(c)(1)(D)(iii) of Public Law 111–148.
p.000759: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000759:
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p.000759: Sec. 464z–3 PUBLIC HEALTH SERVICE ACT 760
p.000759:
p.000759: (b) PRIORITIES.—The Director of the Institute shall in expend- ing amounts appropriated under this subpart
p.000759: give priority to con- ducting and supporting minority health disparities research.
p.000759: (c) MINORITY HEALTH DISPARITIES RESEARCH.—For purposes of this subpart:
p.000759: (1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral research on minority health
p.000759: con- ditions (as defined in paragraph (2)), including research to pre- vent, diagnose, and treat such conditions.
p.000759: (2) The term ‘‘minority health conditions’’, with respect to individuals who are members of minority
p.000759: groups, means all diseases, disorders, and conditions (including with respect to mental health and substance
p.000759: abuse)—
p.000759: (A) unique to, more serious, or more prevalent in such individuals;
p.000759: (B) for which the factors of medical risk or types of medical intervention may be different for such
...

p.000759: (1) shall represent the health disparities research program of the National Institutes of Health, including the
p.000759: minority health disparities research program, at all relevant Executive branch task forces, committees and
p.000759: planning activities; and
p.000759: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000761: 761
p.000761: PUBLIC HEALTH SERVICE ACT
p.000761: Sec. 464z–3
p.000761:
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p.000761: (2) shall maintain communications with all relevant Public Health Service agencies, including the Indian Health
p.000761: Service, and various other departments of the Federal Government to ensure the timely transmission of
p.000761: information concerning ad- vances in minority health disparities research and other health disparities research
p.000761: between these various agencies for dis- semination to affected communities and health care providers.
p.000761: (f) COLLABORATIVE COMPREHENSIVE PLAN AND BUDGET.—
p.000761: (1) IN GENERAL.—Subject to the provisions of this section and other applicable law, the Director of NIH,
p.000761: the Director of the Institute, and the directors of the other agencies of the Na- tional Institutes of Health in
p.000761: collaboration (and in consultation with the advisory council for the Institute) shall—
p.000761: (A) establish a comprehensive plan and budget for the conduct and support of all minority health disparities
p.000761: re- search and other health disparities research activities of the agencies of the National Institutes of
p.000761: Health (which plan and budget shall be first established under this sub- section not later than 12
p.000761: months after the date of the en- actment of this subpart);
p.000761: (B) ensure that the plan and budget establish prior- ities among the health disparities research
p.000761: activities that such agencies are authorized to carry out;
p.000761: (C) ensure that the plan and budget establish objec- tives regarding such activities, describes the means
p.000761: for achieving the objectives, and designates the date by which the objectives are expected to be achieved;
p.000761: (D) ensure that, with respect to amounts appropriated for activities of the Institute, the plan and budget give pri-
p.000761: ority in the expenditure of funds to conducting and sup- porting minority health disparities research;
p.000761: (E) ensure that all amounts appropriated for such ac- tivities are expended in accordance with the plan
p.000761: and budget;
p.000761: (F) review the plan and budget not less than annually, and revise the plan and budget as appropriate;
p.000761: (G) ensure that the plan and budget serve as a broad, binding statement of policies regarding minority health
p.000761: disparities research and other health disparities research activities of the agencies, but do not remove
p.000761: the responsi- bility of the heads of the agencies for the approval of spe- cific programs or projects, or for
p.000761: other details of the daily administration of such activities, in accordance with the plan and budget; and
p.000761: (H) promote coordination and collaboration among the agencies conducting or supporting minority health or other health
p.000761: disparities research.
p.000761: (2) CERTAIN COMPONENTS OF PLAN AND BUDGET.—With re- spect to health disparities research activities of the
p.000761: agencies of the National Institutes of Health, the Director of the Institute shall ensure that the plan and budget
p.000761: under paragraph (1) pro- vide for—
p.000761: (A) basic research and applied research, including re- search and development with respect to products;
p.000761: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000761:
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p.000761: Sec. 464z–3 PUBLIC HEALTH SERVICE ACT 762
p.000761:
p.000761: (B) research that is conducted by the agencies;
p.000761: (C) research that is supported by the agencies;
p.000761: (D) proposals developed pursuant to solicitations by the agencies and for proposals developed independently
p.000761: of such solicitations; and
p.000761: (E) behavioral research and social sciences research, which may include cultural and linguistic research in each
p.000761: of the agencies.
p.000761: (3) MINORITY HEALTH DISPARITIES RESEARCH.—The plan and budget under paragraph (1) shall include a separate
p.000761: state- ment of the plan and budget for minority health disparities re- search.
p.000761: (g) PARTICIPATION IN CLINICAL RESEARCH.—The Director of the Institute shall work with the Director of NIH
p.000761: and the directors of the agencies of the National Institutes of Health to carry out the provisions of
p.000761: section 492B that relate to minority groups.
p.000761: (h) RESEARCH ENDOWMENTS.—
p.000761: (1) IN GENERAL.—The Director of the Institute may carry out a program to facilitate minority health disparities
p.000761: research and other health disparities research by providing for research endowments—
p.000761: (1) at centers of excellence under section 736; and
p.000761: (2) at centers of excellence under section 464z–4. 48
p.000761: (2) ELIGIBILITY.—The Director of the Institute may provide for a research endowment under paragraph (1) only if the
p.000761: insti- tution involved meets the following conditions:
p.000761: (A) The institution does not have an endowment that is worth in excess of an amount equal to 50 percent of the
p.000761: national median of endowment funds at institutions that conduct similar biomedical research or training of
p.000761: health professionals.
p.000761: (B) The application of the institution under paragraph
p.000761: (1) regarding a research endowment has been rec- ommended pursuant to technical and scientific peer
p.000761: review and has been approved by the advisory council under sub- section (j).
p.000761: (i) CERTAIN ACTIVITIES.—In carrying out subsection (a), the Di- rector of the Institute—
p.000761: (1) shall assist the Director of NIH 49 in carrying out sec- tion 404I(c)(2) and in committing resources for
p.000761: construction at Institutions of Emerging Excellence under such section;
p.000761: (2) shall establish projects to promote cooperation among Federal agencies, State, local, tribal, and regional
p.000761: public health agencies, and private entities in health disparities research; and
p.000761:
p.000761:
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p.000761: January 30, 2020
p.000761: 48 So in law. Section 10334(c)(2)(A) of Public Law 111–148 amends (h)(1) by striking and in- serting
p.000761: text that results in two paragraphs (1) and (2). The second paragraph (1) and the first paragraph (2)
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p.000763: January 30, 2020
p.000763: (3) may utilize information from previous health initiatives concerning minorities and other health disparity
p.000763: populations.
p.000763: (j) ADVISORY COUNCIL.—
p.000763: (1) IN GENERAL.—The Secretary shall, in accordance with section 406, establish an advisory council to advise,
p.000763: assist, con- sult with, and make recommendations to the Director of the In- stitute on matters relating to the
p.000763: activities described in sub- section (a), and with respect to such activities to carry out any other functions
p.000763: described in section 406 for advisory councils under such section. Functions under the preceding sentence
p.000763: shall include making recommendations on budgetary alloca- tions made in the plan under subsection (f),
p.000763: and shall include reviewing reports under subsection (k) before the reports are submitted under such
p.000763: subsection.
p.000763: (2) MEMBERSHIP.—With respect to the membership of the advisory council under paragraph (1), a majority of
p.000763: the mem- bers shall be individuals with demonstrated expertise regard- ing minority health disparity and other
p.000763: health disparity issues; representatives of communities impacted by minority and other health disparities shall be
p.000763: included; and a diversity of health professionals shall be represented. The membership shall in addition
p.000763: include a representative of the Office of Behavioral and Social Sciences Research under section 404A.
p.000763: (k) INTRA-NATIONAL INSTITUTES OF HEALTH COORDINATION.— The Director of the Institute, as the primary
p.000763: Federal official with responsibility for coordinating all research and activities conducted or supported by the
p.000763: National Institutes of Health on minority health and health disparities, shall plan, coordinate, review,
p.000763: and evaluate research and other activities conducted or supported by the national research institutes and
p.000763: national centers. The Director of the Institute may foster partnerships between the national re- search
p.000763: institutes and national centers and may encourage the fund- ing of collaborative research projects to achieve the goals
p.000763: of the Na- tional Institutes of Health that are related to minority health and health disparities.
p.000763: SEC. 464z–4. ø285t–1¿ CENTERS OF EXCELLENCE FOR RESEARCH EDU- CATION AND TRAINING.
p.000763: (a) IN GENERAL.—The Director of the Institute shall make awards of grants or contracts to designated biomedical
p.000763: and behav- ioral research institutions under paragraph (1) of subsection (c), or to consortia under paragraph (2) of
p.000763: such subsection, for the purpose of assisting the institutions in supporting programs of excellence in biomedical and
p.000763: behavioral research training for individuals who are members of minority health disparity populations or
p.000763: other health disparity populations.
p.000763: (b) REQUIRED USE OF FUNDS.—An award may be made under subsection (a) only if the applicant involved
p.000763: agrees that the grant will be expended—
p.000763: (1) to train members of minority health disparity popu- lations or other health disparity populations as
p.000763: professionals in the area of biomedical or behavioral research or both; or
p.000763: (2) to expand, remodel, renovate, or alter existing research facilities or construct new research facilities for the
p.000763: purpose of
p.000763: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000763: Sec. 464z–4 PUBLIC HEALTH SERVICE ACT 764
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p.000763: conducting minority health disparities research and other health disparities research.
p.000763: (c) CENTERS OF EXCELLENCE.—
p.000763: (1) IN GENERAL.—For purposes of this section, a designated biomedical and behavioral research institution is a
p.000763: biomedical and behavioral research institution that—
p.000763: (A) has a significant number of members of minority health disparity populations or other health disparity pop-
p.000763: ulations enrolled as students in the institution (including individuals accepted for enrollment in the
p.000763: institution);
p.000763: (B) has been effective in assisting such students of the institution to complete the program of education or
p.000763: train- ing and receive the degree involved;
p.000763: (C) has made significant efforts to recruit minority students to enroll in and graduate from the
p.000763: institution, which may include providing means-tested scholarships and other financial assistance as appropriate;
p.000763: and
p.000763: (D) has made significant recruitment efforts to in- crease the number of minority or other members of health
p.000763: disparity populations serving in faculty or administrative positions at the institution.
p.000763: (2) CONSORTIUM.—Any designated biomedical and behav- ioral research institution involved may, with other
p.000763: biomedical and behavioral institutions (designated or otherwise), including tribal health programs, form a consortium
p.000763: to receive an award under subsection (a).
p.000763: (3) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Director of the
p.000763: Institute for purposes of determining whether institutions meet the con- ditions described in paragraph (1), this
p.000763: section may not, with respect to minority health disparity populations or other health disparity populations, be
p.000763: construed to authorize, require, or prohibit the use of such criteria in any program other than the program
p.000763: established in this section.
p.000763: (d) DURATION OF GRANT.—The period during which payments are made under a grant under subsection (a) may
p.000763: not exceed 5 years. Such payments shall be subject to annual approval by the Director of the Institute
p.000763: and to the availability of appropriations for the fiscal year involved to make the payments.
p.000763: (e) MAINTENANCE OF EFFORT.—
p.000763: (1) IN GENERAL.—With respect to activities for which an award under subsection (a) is authorized to be
p.000763: expended, the Director of the Institute may not make such an award to a des- ignated research institution or
p.000763: consortium for any fiscal year unless the institution, or institutions in the consortium, as the case may be,
p.000763: agree to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the
p.000763: level of such expenditures maintained by the institutions in- volved for the fiscal year preceding the
p.000763: fiscal year for which such institutions receive such an award.
p.000763: (2) USE OF FEDERAL FUNDS.—With respect to any Federal amounts received by a designated research
p.000763: institution or con- sortium and available for carrying out activities for which an award under subsection
p.000763: (a) is authorized to be expended, the
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p.000793: (b)(1) (or modified subcategories as provided for in subsection (b)(2)), of entering into contracts with
p.000793: qualified health professionals under which such health profes- sionals agree to conduct research in
p.000793: consideration of the Federal Government agreeing to repay, for each year of such research, not
p.000793:
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p.000793: 55 The font/style of the section heading shown above conforms with the style of the original section
p.000793: heading for section 487B in all small caps centered heading. See typeface for the amend- ment made by section
p.000793: 2022(b)(1) of Public Law 114–255.
p.000793: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000793: Sec. 487D PUBLIC HEALTH SERVICE ACT 794
p.000793:
p.000793: more than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) contraception or infertility research;
p.000793: (ii) pediatric research, including pediatric pharma- cological research;
p.000793: (iii) minority health disparities research;
p.000793: (iv) clinical research; and
p.000793: (v) clinical research conducted by appropriately qualified health professional who are from disadvan- taged
p.000793: backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
p.000793: elimi- nate one or more subcategories provided for in paragraph (1) due to changes in workforce or
p.000793: scientific needs related to bio- medical research. The Director may establish other sub- category
p.000793: areas based on workforce and scientific priorities if the total number of subcategories does not exceed the
p.000793: number of subcategories listed in paragraph (1).
p.000793: (c) LIMITATION.—The Director of the National Institutes of Health may not enter into a contract with a
p.000793: health professional pursuant to subsection (a) unless such professional has a substan- tial amount of education
p.000793: loans relative to income (as determined pursuant to guidelines issued by the Director).
p.000793: (d) APPLICABILITY OF CERTAIN PROVISIONS REGARDING OBLI- GATED SERVICE.—The provisions of sections 338B,
p.000793: 338C, and 338E shall, except as inconsistent with subsection (a) of this section, apply to the program
p.000793: established in subsection (a) to the same ex- tent and in the same manner as such provisions apply to the
p.000793: Na- tional Health Service Corps Loan Repayment Program established in subpart III of part D of title III.
p.000793: (e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for carrying out this section shall remain available until
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p.000799: applicable on the date of the date of enactment of the Health Research Ex- tension Act of 1985 to grants
p.000799: under this Act for biomedical and behavioral research, and
p.000799: (B) to the extent practical, by technical and scientific peer review groups performing such review on or before
p.000799: such date, and shall authorize such review to be conducted by groups ap-
p.000799: pointed under sections 402(b)(16) and 405(c)(3).
p.000799: (b) The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the
p.000799: National In- stitutes of Health. Such procedures shall require that—
p.000799: (1) the reviewing entity be provided a written description of the research to be reviewed, and
p.000799: (2) the reviewing entity provide the advisory council of the national research institute involved with such
p.000799: description and the results of the review by the entity,
p.000799: and shall authorize such review to be conducted by groups ap- pointed under sections 402(b)(6) and 405(c)(3).
p.000799: (c)(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration
p.000799: of any such pro- posal (including the initial consideration) shall, except as provided in paragraph (2), include an
p.000799: evaluation of the technical and sci- entific merit of the proposal regarding compliance with section
p.000799: 492B.
p.000799: (2) Paragraph (1) shall not apply to any proposal for clinical re- search that, pursuant to subsection (b) of section
p.000799: 492B, is not sub- ject to the requirement of subsection (a) of such section regarding the inclusion of women
p.000799: and members of minority groups as subjects in clinical research.
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p.000799: CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH
p.000799: SEC. 492A. ø289a–1¿ (a) REVIEW AS PRECONDITION TO RE-
p.000799: SEARCH.—
p.000799: (1) PROTECTION OF HUMAN RESEARCH SUBJECTS.—
p.000799: (A) In the case of any application submitted to the Secretary for financial assistance to conduct
p.000799: research, the Secretary may not approve or fund any application that is subject to review under section 491(a)
p.000799: by an Institutional Review Board unless the application has undergone review in accordance with such section
p.000799: and has been rec- ommended for approval by a majority of the members of the Board conducting such
p.000799: review.
p.000799: (B) In the case of research that is subject to review under procedures established by the Secretary for the
p.000799: pro- tection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary
p.000799: may not authorize the conduct of the research unless the research has, pursuant to such procedures, been
p.000799: recommended for approval.
p.000799: (2) PEER REVIEW.—In the case of any proposal for the Na- tional Institutes of Health to conduct or support
p.000799: research, the
p.000799: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000801: amount in excess of the maximum rate of basic pay pay- able for GS–18 of the General Schedule.
p.000801: (J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to
p.000801: each ethics board reasonable staff and assistance to carry out the du- ties of the board.
p.000801: (K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph
p.000801: (B)(ii) is submitted to the Secretary and the congressional com- mittees specified in such subparagraph.
p.000801: (6) DEFINITION.—For purposes of this subsection, the term ‘‘ethical considerations’’ means considerations as to
p.000801: whether the nature of the research involved is such that it is unethical to conduct or support the research.
p.000801:
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p.000801: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH
p.000801: SEC. 492B. ø289a–2¿ (a) REQUIREMENT OF INCLUSION.—
p.000801: (1) IN GENERAL.—In conducting or supporting clinical re- search for purposes of this title, the Director of NIH
p.000801: shall, sub- ject to subsection (b), ensure that—
p.000801: (A) women are included as subjects in each project of such research; and
p.000801: (B) members of minority groups are included as sub- jects in such research.
p.000801: (2) OUTREACH REGARDING PARTICIPATION AS SUBJECTS.— The Director of NIH, in consultation with the
p.000801: Director of the Office of Research on Women’s Health and the Director of the Office of Research on Minority Health,
p.000801: shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects
p.000801: in projects of clinical research.
p.000801: (3) STRATEGIC PLANNING.—
p.000801: (A) IN GENERAL.—The directors of the national insti- tutes and national centers shall consult at least once
p.000801: annu- ally with the Director of the National Institute on Minority Health and Health Disparities and the Director of
p.000801: the Of- fice of Research on Women’s Health regarding objectives of the national institutes and national centers to
p.000801: ensure that future activities by such institutes and centers take into
p.000801: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000803: PUBLIC HEALTH SERVICE ACT
p.000803: Sec. 492B
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p.000803: account women and minorities and are focused on reducing health disparities.
p.000803: (B) STRATEGIC PLANS.—Any strategic plan issued by a national institute or national center shall include details
p.000803: on the objectives described in subparagraph (A).
p.000803: (b) INAPPLICABILITY OF REQUIREMENT.—The requirement estab- lished in subsection (a) regarding women and members of
p.000803: minority groups shall not apply to a project of clinical research if the inclu- sion, as subjects in the project, of
p.000803: women and members of minority groups, respectively—
p.000803: (1) is inappropriate with respect to the health of the sub- jects;
p.000803: (2) is inappropriate with respect to the purpose of the re- search; or
p.000803: (3) is inappropriate under such other circumstances as the Director of NIH may designate.
p.000803: (c) DESIGN OF CLINICAL TRIALS.—
p.000803: (1) IN GENERAL.—In the case of any clinical trial in which women or members of minority groups will under
p.000803: subsection
p.000803: (a) be included as subjects, the Director of NIH shall ensure that the trial is designed and carried
p.000803: out in a manner suffi- cient to provide for a valid analysis of whether the variables being studied in
p.000803: the trial affect women or members of minority groups, as the case may be, differently than other subjects in
p.000803: the trial.
p.000803: (2) REPORTING REQUIREMENTS.—For any new and com- peting project of clinical research subject to the
p.000803: requirements under this section that receives a grant award 1 year after the date of enactment of the 21st
p.000803: Century Cures Act, or any date thereafter, for which a valid analysis is provided under para- graph (1)—
p.000803: (A) and which is an applicable clinical trial as defined in section 402(j), the entity conducting such clinical
p.000803: re- search shall submit the results of such valid analysis to the clinical trial registry data bank
p.000803: expanded under sec- tion 402(j)(3), and the Director of the National Institutes of Health shall, as
p.000803: appropriate, consider whether such en- tity has complied with the reporting requirement described in this subparagraph
p.000803: in awarding any future grant to such entity, including pursuant to section 402(j)(5)(A)(ii) when applicable; and
p.000803: (B) the Director of the National Institutes of Health shall encourage the reporting of the results of
p.000803: such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.
p.000803: (d) GUIDELINES.—
p.000803: (1) IN GENERAL.—Subject to paragraph (2), the Director of NIH, in consultation with the Director of the Office of
p.000803: Research on Women’s Health and the Director of the Office of Research on Minority Health, shall establish guidelines
p.000803: regarding the re- quirements of this section. The guidelines shall include guide- lines regarding—
p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000803: Sec. 492B PUBLIC HEALTH SERVICE ACT 804
p.000803: (A) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical re-
p.000803: search is inappropriate for purposes of subsection (b);
p.000803: (B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c); and
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p.000803: (C) the operation of outreach programs under sub- section (a).
p.000803: (2) CERTAIN PROVISIONS.—With respect to the cir- cumstances under which the inclusion of women or
p.000803: members of minority groups (as the case may be) as subjects in a project of clinical research is
p.000803: inappropriate for purposes of subsection (b), the following applies to guidelines under paragraph (1):
p.000803: (A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the
p.000803: trial is not a permissible consideration in determining whether such inclusion is inappropriate.
p.000803: (ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such
p.000803: inclusion in the project is not a permissible consideration in deter- mining whether such inclusion is
p.000803: inappropriate unless the data regarding women or members of minority groups, re- spectively, that would be obtained
p.000803: in such project (in the event that such inclusion were required) have been or are being obtained through other
p.000803: means that provide data of comparable quality.
p.000803: (B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is
p.000803: not required if there is substantial scientific data demonstrating that there is no significant
p.000803: difference between—
p.000803: (i) the effects that the variables to be studied in the trial have on women or members of
p.000803: minority groups, respectively; and
p.000803: (ii) the effects that the variables have on the indi- viduals who would serve as subjects in the trial in the event
p.000803: that such inclusion were not required.
p.000803: (e) DATE CERTAIN FOR GUIDELINES; APPLICABILITY.—
p.000803: (1) DATE CERTAIN.—The guidelines required in subsection
p.000803: (d) shall be established and published in the Federal Register not later than 180 days after the date of the
p.000803: enactment of the National Institutes of Health Revitalization Act of 1993.
p.000803: (2) APPLICABILITY.—For fiscal year 1995 and subsequent fiscal years, the Director of NIH may not approve any
p.000803: proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health
p.000803: unless the proposal speci- fies the manner in which the research will comply with this section.
p.000803: (f) REPORTS BY ADVISORY COUNCILS.—
p.000803: (1) IN GENERAL.—The advisory council of each national re- search institute shall prepare triennial reports
p.000803: describing the manner in which the institute has complied with this section. Each such report shall be
p.000803: submitted to the Director of the in- stitute involved for inclusion in the triennial report under sec- tion 403.
p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000805: PUBLIC HEALTH SERVICE ACT
p.000805: Sec. 493
p.000805:
p.000805: (2) CONTENTS.—Each triennial report prepared by an advi- sory council of each national research institute as described
p.000805: in paragraph (1) shall include each of the following:
p.000805: (A) The number of women included as subjects, and the proportion of subjects that are women, in any
p.000805: project of clinical research conducted during the applicable report- ing period, disaggregated by categories of
p.000805: research area, condition, or disease, and accounting for single-sex studies.
p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
p.000805:
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p.000805: January 30, 2020
p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
p.000805: (1) ESTABLISHMENT OF OFFICE.—Not later than 90 days after the date of enactment of this section, the Secretary
p.000805: shall establish an office to be known as the Office of Research Integ- rity (referred to in this section as the
p.000805: ‘‘Office’’), which shall be established as an independent entity in the Department of Health and Human
p.000805: Services.
p.000805: (2) APPOINTMENT OF DIRECTOR.—The Office shall be head- ed by a Director, who shall be appointed by the
p.000805: Secretary, be experienced and specially trained in the conduct of research, and have experience in the
p.000805: conduct of investigations of re- search misconduct. The Secretary shall carry out this section acting
p.000805: through the Director of the Office. The Director shall re- port to the Secretary.
p.000805: (3) DEFINITIONS.—
p.000805: (A) The Secretary shall by regulation establish a defi- nition for the term ‘‘research misconduct’’ for purposes
p.000805: of this section.
p.000805: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000805:
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p.000809: (b)(1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which
p.000809: conducts bio- medical and behavioral research with funds provided under this Act (including the National
p.000809: Institutes of Health and the national research institutes) to assure compliance with the guidelines estab- lished
p.000809: under subsection (a).
p.000809: (2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the
p.000809: committee is estab- lished, shall be composed of not fewer than three members, and shall include at
p.000809: least one individual who has no association with such entity and at least one doctor of veterinary medicine.
p.000809: (3) Each animal care committee of a research entity shall—
p.000809: (A) review the care and treatment of animals in all animal study areas and facilities of the research entity at
p.000809: least semi- annually to evaluate compliance with applicable guidelines es- tablished under subsection (a) for
p.000809: appropriate animal care and treatment;
p.000809: (B) keep appropriate records of reviews conducted under subparagraph (A); and
p.000809: (C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a
p.000809: certification that the review has been conducted, and (ii) reports of any vio- lations of guidelines established under
p.000809: subsection (a) or assur- ances required under paragraph (1) which were observed in such review and which have
p.000809: continued after notice by the com- mittee to the research entity involved of the violations.
p.000809: Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.
p.000809: (c) The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement
p.000809: involving research on ani- mals which is administered by the National Institutes of Health or any national research
p.000809: institute to include in its application or con- tract proposal, submitted after the expiration of the
p.000809: twelve-month period beginning on the date of enactment of this section—
p.000809: (1) assurances satisfactory to the Director of NIH that—
p.000809: (A) the applicant meets the requirements of the guide- lines established under paragraphs (1) and (2) of sub-
p.000809: section (a) and has an animal care committee which meets the requirements of subsection (b); and
p.000809: (B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the
p.000809: ap- plicant have available to them instruction or training in
p.000809: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000809:
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p.000809: Sec. 496 PUBLIC HEALTH SERVICE ACT 810
p.000809:
p.000809: the humane practice of animal maintenance and experi- mentation, and the concept, availability, and use
p.000809: of re- search or testing methods that limit the use of animals or limit animal distress; and
p.000809: (2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such
p.000809: grant or contract.
...

p.000817: accreditation of such courses by the Foundation at the State and national level for college or
p.000817: continuing education credits or for degrees;
p.000817: (iv) programs to support and encourage teachers and students of science at all levels of education and
p.000817: programs for the general public which promote the un- derstanding of science;
p.000817: (v) programs for writing, editing, printing, pub- lishing, and vending of books and other materials; and
p.000817: (vi) the conduct of other activities to carry out and support the purpose described in subsection (b).
p.000817: (E) The Cures Acceleration Network described in sec- tion 480.
p.000817: (2) FEES.—The Foundation may assess fees for the provi- sion of professional, administrative and
p.000817: management services by the Foundation in amounts determined reasonable and ap- propriate by the Executive
p.000817: Director.
p.000817: (3) AUTHORITY OF FOUNDATION.—The Foundation shall be the sole entity responsible for carrying out the
p.000817: activities de- scribed in this subsection.
p.000817: (d) BOARD OF DIRECTORS.—
p.000817: (1) COMPOSITION.—
p.000817: (A) The Foundation shall have a Board of Directors (hereafter referred to in this section as the ‘‘Board’’),
p.000817: which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed
p.000817: members of the Board shall be voting members.
p.000817: (B) The ex officio members of the Board shall be—
p.000817: (i) the Chairman and ranking minority member of the Subcommittee on Health and the Environment (Committee on
p.000817: Energy and Commerce) or their des- ignees, in the case of the House of Representatives;
p.000817: (ii) the Chairman and ranking minority member of the Committee on Labor and Human Resources or their
p.000817: designees, in the case of the Senate;
p.000817: (iii) the Director of the National Institutes of Health; and
p.000817: (iv) the Commissioner of Food and Drugs.
p.000817: (C) The ex officio members of the Board under sub- paragraph (B) shall appoint to the Board individuals from
p.000817: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000817:
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p.000817:
p.000819: 819
p.000819: PUBLIC HEALTH SERVICE ACT
p.000819: Sec. 499
p.000819:
p.000819: among a list of candidates to be provided by the National Academy of Science. Such appointed members
p.000819: shall in- clude—
p.000819: (i) representatives of the general biomedical field;
p.000819: (ii) representatives of experts in pediatric medi- cine and research;
p.000819: (iii) representatives of the general biobehavioral field, which may include experts in biomedical ethics;
p.000819: and
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p.000819: January 30, 2020
...

p.000829: Adminis- trator for Women’s Services who shall report directly to the As- sistant Secretary.
p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000829:
p.000829:
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p.000829: Sec. 501 PUBLIC HEALTH SERVICE ACT 830
p.000829:
p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
...

p.000949: proselytization.
p.000949: SEC. 584. ø290kk–3¿ EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG TREATMENT PROGRAMS.
p.000949: (a) FINDINGS.—The Congress finds that—
p.000949: (1) establishing unduly rigid or uniform educational quali- fication for counselors and other personnel in drug
p.000949: treatment programs may undermine the effectiveness of such programs; and
p.000949: (2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug
p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
p.000949:
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000949:
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p.000949:
p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
...

p.001005: together with the school contribution appropriate under subsection (b)(2)(B) of such section to the amount of
p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
p.001005: (2) collections of principal and interest on loans made pur- suant to paragraph (1), and any other earnings of the
p.001005: student loan fund attributable to amounts that are in the fund pursu- ant to such paragraph, will be utilized only for
p.001005: the purpose de- scribed in such paragraph.
p.001005: (b) MINIMUM QUALIFICATIONS FOR SCHOOLS.—The Secretary may not make a Federal capital contribution for
p.001005: purposes of sub- section (a) for a fiscal year unless the health professions school in- volved—
p.001005:
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p.001005: January 30, 2020
p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
p.001005: (2) with respect to health clinics providing services to a significant number of individuals who are
p.001005: from disadvantaged backgrounds, including members of minority groups, to enter into arrangements with 1 or more
p.001005: such clinics for the purpose of providing students of the school with experience in providing clinical services to such
p.001005: individuals;
p.001005: (3) with respect to public or nonprofit private secondary educational institutions and undergraduate
p.001005: institutions of higher education, to enter into arrangements with 1 or more such institutions for the
p.001005: purpose of carrying out programs re- garding the educational preparation of disadvantaged students, including
p.001005: minority students, to enter the health professions and regarding the recruitment of such individuals into
p.001005: the health professions;
p.001005: (4) to establish a mentor program for assisting disadvan- taged students, including minority students,
p.001005: regarding the completion of the educational requirements for degrees from the school;
p.001005: (5) to be carrying out each of the activities specified in any of paragraphs (1) through (4) by not later than 1 year
p.001005: after the date on which the first Federal capital contribution is made to the school for purposes of subsection (a);
p.001005: and
p.001005: (6) to continue carrying out such activities, and the activi- ties specified in paragraphs (1) and (2) of
p.001005: subsection (b),
p.001005: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001005:
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p.001005: Sec. 725 PUBLIC HEALTH SERVICE ACT 1006
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p.001005:
p.001005: throughout the period during which the student loan fund es- tablished pursuant to section 721(b) is in
...

p.001009: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making Federal capital contributions to student
p.001009: loan funds established under section 721 by schools of medicine or osteo- pathic medicine, there is
p.001009: authorized to be appropriated
p.001009: $10,000,000 for each of the fiscal years 1994 through 1996.
p.001009: (2) MINIMUM REQUIREMENTS.—
p.001009: (A) Subject to subparagraph (B), the Secretary may make a Federal capital contribution pursuant to paragraph
p.001009: (1) only if the school of medicine or osteopathic medicine involved meets the conditions described in
p.001009: subparagraph
p.001009: (A) of section 723(b)(2) or the conditions described in sub- paragraph (C) of such section.
p.001009: (B) For purposes of subparagraph (A), the conditions referred to in such subparagraph shall be applied with re-
p.001009: spect to graduates of the school involved whose date of graduation occurred approximately 3 years before June
p.001009: 30 of the fiscal year preceding the fiscal year for which the Federal capital contribution involved is made.
p.001009:
p.001009: PART B—HEALTH PROFESSIONS TRAINING FOR DIVERSITY
p.001009: SEC. 736. ø293¿ CENTERS OF EXCELLENCE.
p.001009: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, designated health
p.001009: professions schools de- scribed in subsection (c), and other public and nonprofit health or educational
p.001009: entities, for the purpose of assisting the schools in sup- porting programs of excellence in health professions
p.001009: education for under-represented minority individuals.
p.001009: (b) REQUIRED USE OF FUNDS.—The Secretary may not make a grant under subsection (a) unless the designated health
p.001009: professions school involved agrees, subject to subsection (c)(1)(C), to expend the grant—
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p.001009: January 30, 2020
p.001009: (1) to develop a large competitive applicant pool through linkages with institutions of higher education, local
p.001009: school dis- tricts, and other community-based entities and establish an education pipeline for health
p.001009: professions careers;
p.001009: (2) to establish, strengthen, or expand programs to en- hance the academic performance of under-represented
p.001009: minority students attending the school;
p.001009: (3) to improve the capacity of such school to train, recruit, and retain under-represented minority faculty
p.001009: including the payment of such stipends and fellowships as the Secretary may determine appropriate;
p.001009: (4) to carry out activities to improve the information re- sources, clinical education, curricula and
p.001009: cultural competence of the graduates of the school, as it relates to minority health issues;
p.001009: (5) to facilitate faculty and student research on health issues particularly affecting
p.001009: under-represented minority groups, including research on issues relating to the delivery of health care;
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001009:
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p.001009: Sec. 736 PUBLIC HEALTH SERVICE ACT 1010
p.001009:
p.001009: (6) to carry out a program to train students of the school in providing health services to a
p.001009: significant number of under- represented minority individuals through training provided to such students at
p.001009: community-based health facilities that—
p.001009: (A) provide such health services; and
p.001009: (B) are located at a site remote from the main site of the teaching facilities of the school; and
p.001009: (7) to provide stipends as the Secretary determines appro- priate, in amounts as the Secretary determines appropriate.
p.001009: (c) CENTERS OF EXCELLENCE.—
p.001009: (1) DESIGNATED SCHOOLS.—
p.001009: (A) IN GENERAL.—The designated health professions schools referred to in subsection (a) are such schools
p.001009: that meet each of the conditions specified in subparagraphs (B) and (C), and that—
p.001009: (i) meet each of the conditions specified in para- graph (2)(A);
p.001009: (ii) meet each of the conditions specified in para- graph (3);
p.001009: (iii) meet each of the conditions specified in para- graph (4); or
p.001009: (iv) meet each of the conditions specified in para- graph (5).
p.001009: (B) GENERAL CONDITIONS.—The conditions specified in this subparagraph are that a designated health professions school—
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p.001009: (i) has a significant number of under-represented minority individuals enrolled in the school, including
p.001009: individuals accepted for enrollment in the school;
p.001009: (ii) has been effective in assisting under-rep- resented minority students of the school to complete
p.001009: the program of education and receive the degree in- volved;
p.001009: (iii) has been effective in recruiting under-rep- resented minority individuals to enroll in and grad-
p.001009: uate from the school, including providing scholarships and other financial assistance to such individuals and
p.001009: encouraging under-represented minority students from all levels of the educational pipeline to pursue health
p.001009: professions careers; and
p.001009: (iv) has made significant recruitment efforts to in- crease the number of under-represented minority indi- viduals
p.001009: serving in faculty or administrative positions at the school.
p.001009: (C) CONSORTIUM.—The condition specified in this sub- paragraph is that, in accordance with subsection (e)(1), the
p.001009: designated health profession school involved has with other health profession schools (designated or
p.001009: otherwise) formed a consortium to carry out the purposes described in subsection (b) at the schools of the consortium.
p.001009: (D) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Secretary
p.001009: for purposes of determining whether schools meet the condi- tions described in subparagraph (B), this section
p.001009: may not,
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
p.001011: (A) CONDITIONS.—The conditions specified in this sub- paragraph are that a designated health professions
p.001011: school—
p.001011: (i) is a school described in section 799B(1); and
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p.001011: (A) with respect to other centers of excellence, the con- ditions described in clauses (i) through (iv) of
p.001011: paragraph (1)(B); and
p.001011: (B) that the health professions school involved has an enrollment of under-represented minorities above the na-
p.001011: tional average for such enrollments of health professions schools.
p.001011: (d) DESIGNATION AS CENTER OF EXCELLENCE.—
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001013: 1013
p.001013: PUBLIC HEALTH SERVICE ACT
p.001013: Sec. 736
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p.001013: (1) IN GENERAL.—Any designated health professions school receiving a grant under subsection (a) and meeting the
p.001013: condi- tions described in paragraph (2) or (5) of subsection (c) shall, for purposes of this section, be
p.001013: designated by the Secretary as a Center of Excellence in Under-Represented Minority Health Professions
p.001013: Education.
p.001013: (2) HISPANIC CENTERS OF EXCELLENCE.—Any designated health professions school receiving a grant under subsection
p.001013: (a) and meeting the conditions described in subsection (c)(3) shall, for purposes of this section, be designated by the
p.001013: Secretary as a Hispanic Center of Excellence in Health Professions Edu- cation.
p.001013: (3) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Any des- ignated health professions school receiving a grant under
p.001013: sub- section (a) and meeting the conditions described in subsection (c)(4) shall, for purposes of this
p.001013: section, be designated by the Secretary as a Native American Center of Excellence in Health Professions Education.
p.001013: Any consortium receiving such a grant pursuant to subsection (e) shall, for purposes of this section, be so
p.001013: designated.
p.001013: (e) AUTHORITY REGARDING NATIVE AMERICAN CENTERS OF EX- CELLENCE.—With respect to meeting the conditions
p.001013: specified in subsection (c)(4), the Secretary may make a grant under subsection
p.001013: (a) to a designated health professions school that does not meet such conditions if—
p.001013: (1) the school has formed a consortium in accordance with subsection (d)(1); and
p.001013: (2) the schools of the consortium collectively meet such conditions, without regard to whether the
p.001013: schools individually meet such conditions.
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p.001015: ships may be expended only for tuition expenses, other reasonable educational expenses, and reasonable living
p.001015: expenses incurred in the attendance of such school.
p.001015: (b) PREFERENCE IN PROVIDING SCHOLARSHIPS.—The Secretary may not make a grant to an entity under subsection (a)
p.001015: unless the health professions and nursing schools involved agree that, in pro- viding scholarships pursuant to the
p.001015: grant, the schools will give preference to students for whom the costs of attending the schools would constitute
p.001015: a severe financial hardship and, notwithstanding other provisions of this section, to former recipients of
p.001015: scholarships under sections 736 and 740(d)(2)(B) (as such sections existed on the day before the date of enactment of
p.001015: this section).
p.001015: (c) AMOUNT OF AWARD.—In awarding grants to eligible entities that are health professions and nursing schools, the
p.001015: Secretary shall give priority to eligible entities based on the proportion of grad- uating students going
p.001015: into primary care, the proportion of under- represented minority students, and the proportion of graduates
p.001015: working in medically underserved communities.
p.001015: (d) DEFINITIONS.—In this section:
p.001015: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means an entity that—
p.001015: (A) is a school of medicine, osteopathic medicine, den- tistry, nursing (as defined in section 801),
p.001015: pharmacy, podiatric medicine, optometry, veterinary medicine, public health, chiropractic, or allied health,
p.001015: a school offering a graduate program in behavioral and mental health prac- tice, or an entity providing
p.001015: programs for the training of physician assistants; and
p.001015: (B) is carrying out a program for recruiting and retain- ing students from disadvantaged backgrounds, including
p.001015: students who are members of racial and ethnic minority groups.
p.001015: (2) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who—
p.001015: (A) is from a disadvantaged background;
p.001015: (B) has a financial need for a scholarship; and
p.001015: (C) is enrolled (or accepted for enrollment) at an eligi- ble health professions or nursing school as a full-time stu-
p.001015: dent in a program leading to a degree in a health profes- sion or nursing.
p.001015: SEC. 738. ø293b¿ LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY POSITIONS.
p.001015: (a) LOAN REPAYMENTS.—
p.001015: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program of entering into contracts with
p.001015: individuals described in paragraph (2) under which the individuals agree to serve as members of the
p.001015: faculties of schools described in paragraph (3) in consideration of the Federal Government agreeing
p.001015: to pay, for each year of such service, not more than
p.001015: $30,000 of the principal and interest of the educational loans of such individuals.
p.001015: (2) ELIGIBLE INDIVIDUALS.—The individuals referred to in paragraph (1) are individuals from disadvantaged
p.001015: backgrounds who—
p.001015: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001017: PUBLIC HEALTH SERVICE ACT
p.001017: Sec. 738
p.001017:
p.001017: (A) have a degree in medicine, osteopathic medicine, dentistry, nursing, or another health profession;
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p.001017: to the individual for serving as a member of the fac- ulty, will make the determination without regard
p.001017: to the amount of payments made (or to be made) to the individual by the Federal Government under para-
p.001017: graph (1).
p.001017: (5) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of sections 338C, 338G, and 338I shall apply to the
p.001017: program established in paragraph (1) to the same extent and in the same manner as such provisions apply to
p.001017: the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III,
p.001017: including the applicability of provi- sions regarding reimbursements for increased tax liability and regarding
p.001017: bankruptcy.
p.001017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001017: Sec. 738 PUBLIC HEALTH SERVICE ACT 1018
p.001017:
p.001017: (6) WAIVER REGARDING SCHOOL CONTRIBUTIONS.—The Sec- retary may waive the requirement established in
p.001017: paragraph (4)(B) if the Secretary determines that the requirement will impose an undue financial hardship on
p.001017: the school involved.
p.001017: (b) FELLOWSHIPS.—
p.001017: (1) IN GENERAL.—The Secretary may make grants to and enter into contracts with eligible entities to assist such
p.001017: entities in increasing the number of underrepresented minority individ- uals who are members of the faculty of such
p.001017: schools.
p.001017: (2) APPLICATIONS.—To be eligible to receive a grant or con- tract under this subsection, an entity shall provide
p.001017: an assur- ance, in the application submitted by the entity, that—
p.001017: (A) amounts received under such a grant or contract will be used to award a fellowship to an individual only if
p.001017: the individual meets the requirements of paragraphs (3) and (4); and
p.001017: (B) each fellowship awarded pursuant to the grant or contract will include—
p.001017: (i) a stipend in an amount not exceeding 50 per- cent of the regular salary of a similar faculty member for
p.001017: not to exceed 3 years of training; and
p.001017: (ii) an allowance for other expenses, such as travel to professional meetings and costs related to special- ized
p.001017: training.
p.001017: (3) ELIGIBILITY.—To be eligible to receive a grant or con- tract under paragraph (1), an applicant shall
p.001017: demonstrate to the Secretary that such applicant has or will have the ability to—
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p.001017: (A) identify, recruit and select underrepresented mi- nority individuals who have the potential for teaching, ad-
p.001017: ministration, or conducting research at a health profes- sions institution;
p.001017: (B) provide such individuals with the skills necessary to enable them to secure a tenured faculty position at
p.001017: such institution, which may include training with respect to pedagogical skills, program administration, the
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p.001017: years at a level that is equal to the total amount of institu- tional funds provided in the year in which the
p.001017: grant or contract was awarded;
p.001017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001019: 1019
p.001019: PUBLIC HEALTH SERVICE ACT
p.001019: Sec. 739
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p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
p.001019: (B) facilitating the entry of such individuals into such a school;
p.001019: (C) providing counseling, mentoring, or other services designed to assist such individuals to complete
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p.001021: directly or through donations from public or private entities and may be in cash or in- kind, fairly evaluated,
p.001021: including plant, equipment, or services.
p.001021: SEC. 740. ø293d¿ AUTHORIZATION OF APPROPRIATION.
p.001021: (a) SCHOLARSHIPS.—There are authorized to be appropriated to carry out section 737, $51,000,000 for fiscal year
p.001021: 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2014. Of the amount appropriated in
p.001021: any fiscal year, the Secretary shall ensure that not less than 16 percent shall be distributed to schools of
p.001021: nursing.
p.001021: (b) LOAN REPAYMENTS AND FELLOWSHIPS.—For the purpose of carrying out section 738, there is authorized to
p.001021: be appropriated,
p.001021: $5,000,000 for each of the fiscal years 2010 through 2014.
p.001021: (c) EDUCATIONAL ASSISTANCE IN HEALTH PROFESSIONS REGARD- ING INDIVIDUALS FOR DISADVANTAGED BACKGROUNDS.—For
p.001021: the pur- pose of grants and contracts under section 739(a)(1), there is au- thorized to be appropriated
p.001021: $60,000,000 for fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011
p.001021: through 2014. The Secretary may use not to exceed 20 percent of the amount appropriated for a fiscal
p.001021: year under this subsection to provide scholarships under section 739(a)(2)(F).
p.001021: (d) REPORT.—Not later than 6 months after the date of enact- ment of this part, the Secretary shall
p.001021: prepare and submit to the appropriate committees of Congress a report concerning the efforts of the Secretary to
p.001021: address the need for a representative mix of in- dividuals from historically minority health professions schools,
p.001021: or from institutions or other entities that historically or by geographic location have a demonstrated record
p.001021: of training or educating underrepresented minorities, within various health professions dis- ciplines, on peer
p.001021: review councils.
p.001021: SEC. 741. ø293e¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001021: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—
p.001021: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001021: Administra- tion, may make awards of grants, contracts, or cooperative agreements to public and nonprofit
p.001021: private entities (including tribal entities) for the development, evaluation, and dissemina- tion of research,
p.001021: demonstration projects, and model curricula for cultural competency, prevention, public health proficiency,
p.001021: reducing health disparities, and aptitude for working with indi- viduals with disabilities training for use in
p.001021: health professions schools and continuing education programs, and for other pur- poses determined as appropriate by
p.001021: the Secretary.
p.001021: (2) ELIGIBLE ENTITIES.—Unless specifically required other- wise in this title, the Secretary shall accept
p.001021: applications for grants or contracts under this section from health professions schools, academic health
p.001021: centers, State or local governments, or other appropriate public or private nonprofit entities (or con- sortia of
p.001021: entities, including entities promoting multidisciplinary approaches) for funding and participation in health
p.001021: professions training activities. The Secretary may accept applications from
p.001021: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: Sec. 747 PUBLIC HEALTH SERVICE ACT 1022
p.001021:
p.001021: for-profit private entities as determined appropriate by the Secretary.
p.001021: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with health professional
p.001021: societies, licensing and accreditation entities, health professions schools, and experts in minority health and
p.001021: cultural competency, prevention, and public health and disability groups, community-based organizations, and
p.001021: other organizations as determined appropriate by the Secretary. The Secretary shall coordinate with
p.001021: curricula and research and demonstration projects developed under section 807.
p.001021: (c) DISSEMINATION.—
p.001021: (1) IN GENERAL.—Model curricula developed under this section shall be disseminated through the Internet
p.001021: Clearing- house under section 270 and such other means as determined appropriate by the Secretary.
p.001021: (2) EVALUATION.—The Secretary shall evaluate the adop- tion and the implementation of cultural competency,
p.001021: preven- tion, and public health, and working with individuals with a disability training curricula, and
p.001021: the facilitate inclusion of these competency measures in quality measurement systems as appropriate.
p.001021: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.001021: such sums as may be necessary for each of fiscal years 2010 through 2015.
p.001021:
p.001021: PART C—TRAINING IN FAMILY MEDICINE, GENERAL INTERNAL MEDICINE, GENERAL PEDIATRICS, PHYSICIAN
p.001021: ASSISTANTS, GEN- ERAL DENTISTRY, AND PEDIATRIC DEN- TISTRY
p.001021: Subpart I—Medical Training Generally
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p.001023: (2) PREFERENCE IN MAKING AWARDS UNDER THIS SUB- SECTION.—In making awards of grants and
p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
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p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
p.001027: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001027: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001027: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 8, the Secretary shall
p.001027: appoint the members of the Advisory Committee from among individuals who are health professionals. In
p.001027: making such appointments, the Secretary shall ensure a fair balance between the health professions, that at
p.001027: least 75 percent of the members of the Ad- visory Committee are health professionals, a broad geographic representation
p.001027: of members and a balance between urban and rural members. Members shall be appointed based on their
p.001027: competence, interest, and knowledge of the mission of the pro- fession involved.
p.001027: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001027: the Sec-
p.001027:
p.001027:
p.001027:
p.001027:
p.001027:
p.001027: January 30, 2020
p.001027: 8 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted
p.001027: July 1, 1944. Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which
p.001027: added section 748. That Act is Public Law 105–392, enacted November 13, 1998. (Section 102(4) of that Public Law (112
p.001027: Stat. 3539) added section 748.)
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001029: 1029
p.001029: PUBLIC HEALTH SERVICE ACT
p.001029: Sec. 749
p.001029:
p.001029: retary shall ensure the adequate representation of women and minorities.
p.001029: (c) TERMS.—
p.001029: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001029: that of the members first appointed—
p.001029: (A) 1⁄3 of such members shall serve for a term of 1 year;
p.001029: (B) 1⁄3 of such members shall serve for a term of 2 years; and
p.001029: (C) 1⁄3 of such members shall serve for a term of 3 years.
p.001029: (2) VACANCIES.—
p.001029: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
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p.001033: medicine or osteopathic medicine, an incorporated con- sortium of such schools, or the parent institutions
p.001033: of such a school. With respect to a State in which no area health education center program is in
p.001033: operation, the Secretary may award a grant or contract under subsection (a)(1) to a school of nursing.
p.001033: (B) POINT OF SERVICE MAINTENANCE AND ENHANCE- MENT.—For purposes of subsection (a)(2), the term ‘‘eligible
p.001033: entity’’ means an entity that has received funds under this section, is operating an area health education
p.001033: center pro- gram, including an area health education center or cen- ters, and has a center or centers that are
p.001033: no longer eligible to receive financial assistance under subsection (a)(1).
p.001033: (2) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001033: Secretary an ap- plication at such time, in such manner, and containing such in- formation as the Secretary may
p.001033: require.
p.001033: (c) USE OF FUNDS.—
p.001033: (1) REQUIRED ACTIVITIES.—An eligible entity shall use amounts awarded under a grant under subsection
p.001033: (a)(1) or (a)(2) to carry out the following activities:
p.001033: (A) Develop and implement strategies, in coordination with the 10applicable one-stop delivery system under sec-
p.001033: tion 134(c) of the Workforce Investment Act of 1998, to re- cruit individuals from underrepresented minority popu-
p.001033: lations or from disadvantaged or rural backgrounds into
p.001033:
p.001033:
p.001033:
p.001033:
p.001033:
p.001033: January 30, 2020
p.001033: 10 Effective on July 1, 2015, section 512(z)(2) of Public Law 113–128 provides for an amend- ment to
p.001033: strike ‘‘the applicable one-stop delivery system under section 134(c) of the Workforce Investment Act of
p.001033: 1998,’’ and insert ‘‘the applicable one-stop delivery system under section 121(e) of the Workforce Innovation
p.001033: and Opportunity Act,’’.
p.001033: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001033:
p.001033:
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p.001035: 1035
p.001035: PUBLIC HEALTH SERVICE ACT
p.001035: Sec. 751
p.001035:
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p.001035: health professions, and support such individuals in attain- ing such careers.
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p.001037: Sec. 752 PUBLIC HEALTH SERVICE ACT 1038
p.001037:
p.001037: (B) not less than 60 percent shall be used for awards under subsection (a)(2);
p.001037: (C) not more than 1 percent shall be used for grants and contracts to implement outcomes evaluation for
p.001037: the area health education centers; and
p.001037: (D) not more than 4 percent shall be used for grants and contracts to provide technical assistance to
p.001037: entities re- ceiving awards under this section.
p.001037: (3) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from 1
p.001037: fiscal year to another without obtaining approval from the Secretary. In no case may any funds be carried
p.001037: over pursuant to the preceding sentence for more than 3 years.
p.001037: (k) SENSE OF CONGRESS.—It is the sense of the Congress that every State have an area health education center
p.001037: program in effect under this section.
p.001037: SEC. 752. ø294b¿ CONTINUING EDUCATIONAL SUPPORT FOR HEALTH PROFESSIONALS SERVING IN UNDERSERVED COMMU-
p.001037: NITIES.
p.001037: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, eligible entities to
p.001037: improve health care, increase retention, increase representation of minority faculty members, enhance
p.001037: the practice environment, and provide informa- tion dissemination and educational support to reduce
p.001037: professional isolation through the timely dissemination of research findings using relevant resources.
p.001037: (b) ELIGIBLE ENTITIES.—For purposes of this section, the term ‘‘eligible entity’’ means an entity described in section
p.001037: 799(b).
p.001037: (c) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001037: Secretary an applica- tion at such time, in such manner, and containing such information as the Secretary may require.
p.001037: (d) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant or contract under this
p.001037: section to provide in- novative supportive activities to enhance education through dis- tance learning,
p.001037: continuing educational activities, collaborative con- ferences, and electronic and telelearning activities, with
p.001037: priority for primary care.
p.001037: (e) AUTHORIZATION.—There is authorized to be appropriated to carry out this section $5,000,000 for each of the
p.001037: fiscal years 2010 through 2014, and such sums as may be necessary for each subse- quent fiscal year.
p.001037: SEC. 753. ø294c¿ EDUCATION AND TRAINING RELATING TO GERI- ATRICS.
p.001037: (a) GERIATRIC EDUCATION CENTERS.—
p.001037: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to entities described in
...

p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001047:
p.001047: Sec. 757 PUBLIC HEALTH SERVICE ACT 1048
p.001047:
p.001047: port submitted to Congress under section 501(m) an assessment on the effectiveness of the grants under this section in—
p.001047: (1) providing graduate students support for experiential training (internship or field placement);
p.001047: (2) recruiting students interested in behavioral health practice;
p.001047: (3) recruiting students in accordance with subsection (b)(1);
...

p.001047: (1) For grants described in subsection (a)(1), $15,000,000.
p.001047: (2) For grants described in subsection (a)(2), $15,000,000.
p.001047: (3) For grants described in subsection (a)(3), $10,000,000.
p.001047: (4) For grants described in subsection (a)(4), $10,000,000.
p.001047: SEC. 757. ø294f¿ ADVISORY COMMITTEE ON INTERDISCIPLINARY, COM- MUNITY-BASED LINKAGES.
p.001047: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001047: Interdiscipli- nary, Community-Based Linkages (in this section referred to as the ‘‘Advisory Committee’’).
p.001047: (b) COMPOSITION.—
p.001047: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001047: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001047: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 12, the Secretary
p.001047: shall appoint the members of the Advisory Committee from among individuals who are health professionals
p.001047: from schools of the types de- scribed in sections 751(b)(1)(A), 753(b), and 755(b). In making such
p.001047: appointments, the Secretary shall ensure a fair balance between the health professions, that at least 75 percent
p.001047: of the members of the Advisory Committee are health professionals, a broad geographic representation of
p.001047: members and a balance between urban and rural members. Members shall be ap- pointed based on their
p.001047: competence, interest, and knowledge of the mission of the profession involved.
p.001047: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001047: the Sec- retary shall ensure the adequate representation of women and minorities.
p.001047: (c) TERMS.—
p.001047:
p.001047:
p.001047:
p.001047:
p.001047:
p.001047: January 30, 2020
p.001047: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001047: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 756.
p.001047: That Act is Public Law 105–392, enacted November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541) added
p.001047: section 756.)
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001049: 1049
p.001049: PUBLIC HEALTH SERVICE ACT
p.001049: Sec. 757
p.001049:
p.001049: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001049: that of the members first appointed—
p.001049: (A) 1⁄3 of the members shall serve for a term of 1 year;
p.001049: (B) 1⁄3 of the members shall serve for a term of 2 years; and
p.001049: (C) 1⁄3 of the members shall serve for a term of 3 years.
p.001049: (2) VACANCIES.—
p.001049: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
...

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p.001053: January 30, 2020
p.001053:
p.001053: (i) the delivery of mental and substance use dis- orders services at the eligible entities described in sub-
p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
...

p.001071: health professions personnel as the Secretary may require.
p.001071: (b) CERTAIN AUTHORITIES AND REQUIREMENTS.—
p.001071: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001073: 1073
p.001073: PUBLIC HEALTH SERVICE ACT
p.001073: Sec. 792
p.001073:
p.001073: (1) SOURCES OF INFORMATION.—In carrying out subsection (a), the Secretary shall collect available
p.001073: information from ap- propriate local, State, and Federal agencies and other appro- priate sources.
p.001073: (2) CONTRACTS FOR STUDIES OF HEALTH PROFESSIONS.—The Secretary shall conduct or enter into contracts for the
p.001073: conduct of analytic and descriptive studies of the health professions, in- cluding evaluations and projections of
p.001073: the supply of, and re- quirements for, the health professions by specialty and geo- graphic location.
p.001073: Such studies shall include studies deter- mining by specialty and geographic location the number of
p.001073: health professionals (including allied health professionals and health care administration personnel) who are
p.001073: members of mi- nority groups, including Hispanics, and studies providing by specialty and geographic location
p.001073: evaluations and projections of the supply of, and requirements for, health professionals (in- cluding allied
p.001073: health professionals and health care administra- tion personnel) to serve minority groups, including Hispanics.
p.001073: (3) GRANTS AND CONTRACTS REGARDING STATES.—The Sec- retary is authorized to make grants and to enter into
p.001073: contracts with States (or an appropriate nonprofit private entity in any State) for the purpose of
p.001073: participating in the program estab- lished under subsection (a). The Secretary shall determine the amount and scope
p.001073: of any such grant or contract. To be eligible for a grant or contract under this paragraph a State or entity
p.001073: shall submit an application in such form and manner and con- taining such information as the Secretary shall
p.001073: require. Such application shall include reasonable assurance, satisfactory to the Secretary, that—
p.001073: (A) such State (or nonprofit entity within a State) will establish a program of mandatory annual registration of
p.001073: the health professions personnel described in subsection
p.001073: (a) who reside or practice in such State and of health insti- tutions licensed by such State, which registration shall
p.001073: in- clude such information as the Secretary shall determine to be appropriate;
p.001073: (B) such State or entity shall collect such information and report it to the Secretary in such form and manner
p.001073: as the Secretary shall prescribe; and
p.001073: (C) such State or entity shall comply with the require- ments of subsection (e).
p.001073: (d) 17 REPORTS TO CONGRESS.—The Secretary shall submit to the Congress on October 1, 1993, and biennially
p.001073: thereafter, the fol- lowing reports:
p.001073: (1) A comprehensive report regarding the status of health personnel according to profession, including a report
p.001073: regarding the analytic and descriptive studies conducted under this sec- tion.
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p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
p.001083:
p.001083:
p.001083:
p.001083:
p.001083: January 30, 2020
p.001083: 26 Effective on July 1, 2015, section 512(z)(3) of Public Law 113–128 provides for an amend- ment to
p.001083: strike ‘‘one-stop delivery system described in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C.
p.001083: 2864(c))’’ and insert ‘‘one-stop delivery system described in section 121(e) of the Workforce Innovation and
p.001083: Opportunity Act’’.
...

p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
p.001089:
p.001089:
p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001089:
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p.001091: 1091
p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
p.001091: Islander Nurses, the Native American Indian and Alas- kan Nurses Association, and the National Council of State
p.001091: Boards of Nursing, and other organizations determined appropriate by the Secretary.
p.001091: (c) REQUIRED INFORMATION AND CONDITIONS FOR AWARD RE-
p.001091: CIPIENTS.—
p.001091: (1) IN GENERAL.—Recipients of awards under this section may be required, where requested, to report to
p.001091: the Secretary concerning the annual admission, retention, and graduation rates for individuals from
p.001091: disadvantaged backgrounds and eth- nic and racial minorities in the school or schools involved in the
p.001091: projects.
p.001091: (2) FALLING RATES.—If any of the rates reported under paragraph (1) fall below the average of the two previous
p.001091: years, the grant or contract recipient shall provide the Secretary with plans for immediately improving such rates.
p.001091: (3) INELIGIBILITY.—A recipient described in paragraph (2) shall be ineligible for continued funding under
p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
p.001091:
p.001091:
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p.001107: Govern- ment, appointed by the Secretary without regard to the Federal civil service laws, of which—
p.001107: (i) 2 shall be selected from full-time students en- rolled in schools of nursing;
p.001107: (ii) 2 shall be selected from the general public;
p.001107: (iii) 2 shall be selected from practicing profes- sional nurses; and
p.001107: (iv) 9 shall be selected from among the leading au- thorities in the various fields of nursing, higher, sec-
p.001107: ondary education, and associate degree schools of nursing, and from representatives of advanced edu-
p.001107: cation nursing groups (such as nurse practitioners, nurse midwives, and nurse anesthetists), hospitals, and
p.001107: other institutions and organizations which provide nursing services; and
p.001107: (B) the Secretary (or the delegate of the Secretary (who shall be an ex officio member and shall serve as the
p.001107: Chairperson)).
p.001107: (2) APPOINTMENT.—Not later than 90 days after the date
p.001107: of enactment of this Act 12, the Secretary shall appoint the members of the Advisory Council and each such
p.001107: member shall serve a 4 year term. In making such appointments, the Sec- retary shall ensure a fair balance
p.001107: between the nursing profes- sions, a broad geographic representation of members and a bal- ance between urban and rural
p.001107: members. Members shall be ap- pointed based on their competence, interest, and knowledge of the mission of the
p.001107: profession involved. A majority of the mem- bers shall be nurses.
p.001107: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Council under paragraph (1),
p.001107: the Sec- retary shall ensure the adequate representation of minorities.
p.001107: (c) VACANCIES.—
p.001107: (1) IN GENERAL.—A vacancy on the Advisory Council shall be filled in the manner in which the original appointment was
p.001107: made and shall be subject to any conditions which applied with respect to the original appointment.
p.001107:
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p.001107: January 30, 2020
p.001107: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001107: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 845.
p.001107: That Act is Public Law 105–392, enacted November 13, 1998. (Section 123(5) of that Public Law (112 Stat. 3569) added
p.001107: section 845.)
p.001107: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001109: 1109
p.001109: PUBLIC HEALTH SERVICE ACT
p.001109: Sec. 851
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p.001111: Director shall con-
p.001111:
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p.001111: January 30, 2020
p.001111: 1 Section 2 of Public Law 106–129 (113 Stat. 1653) designated the Agency as the Agency for Healthcare
p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001113: 1113
p.001113: PUBLIC HEALTH SERVICE ACT
p.001113: Sec. 902
p.001113:
p.001113: duct and support research and evaluations, and support dem- onstration projects, with respect to—
p.001113: (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and
p.001113: (B) health care for priority populations, which shall in- clude—
p.001113:
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p.001113: January 30, 2020
p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
p.001113: (5) health care technologies, facilities, and equipment;
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p.001115: January 30, 2020
p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
p.001115: (5) in carrying out section 902(c), provide support to in- crease the number of researchers who are
p.001115: members of health disparity populations, and the health services research capac- ity of institutions that
p.001115: train such researchers; and
p.001115: (6) beginning with fiscal year 2003, annually submit to the Congress a report regarding prevailing disparities in
p.001115: health care delivery as it relates to racial factors and socioeconomic factors in priority populations.
p.001115: (b) RESEARCH AND DEMONSTRATION PROJECTS.—
p.001115: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor shall conduct and support research and support
p.001115: demonstra- tions to—
p.001115: (A) identify the clinical, cultural, socioeconomic, geo- graphic, and organizational factors that
p.001115: contribute to health disparities, including minority health disparity pop- ulations, which research shall include
p.001115: behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach,
p.001115: and the availability of related support services (such as cultural and linguistic services);
p.001115: (B) identify and evaluate clinical and organizational strategies to improve the quality, outcomes, and
p.001115: access to care for health disparity populations, including minority health disparity populations;
p.001115: (C) test such strategies and widely disseminate those strategies for which there is scientific evidence of
p.001115: effective- ness; and
p.001115: (D) determine the most effective approaches for dis- seminating research findings to health disparity
p.001115: popu- lations, including minority populations.
p.001115: (2) USE OF CERTAIN STRATEGIES.—In carrying out this sec- tion, the Director shall implement research
p.001115: strategies and mechanisms that will enhance the involvement of individuals who are members of minority
p.001115: health disparity populations or other health disparity populations, health services researchers who are such
p.001115: individuals, institutions that train such individ- uals as researchers, members of minority health disparity pop-
p.001115: ulations or other health disparity populations for whom the Agency is attempting to improve the quality
p.001115: and outcomes of care, and representatives of appropriate tribal or other commu- nity-based organizations with respect
p.001115: to health disparity popu- lations. Such research strategies and mechanisms may include the use of—
p.001115: (A) centers of excellence that can demonstrate, either individually or through consortia, a combination of
p.001115: multi- disciplinary expertise in outcomes or quality improvement research, linkages to relevant sites of
p.001115: care, and a dem- onstrated capacity to involve members and communities of health disparity populations,
p.001115: including minority health disparity populations, in the planning, conduct, dissemina- tion, and translation of
p.001115: research;
p.001115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001115: Sec. 903 PUBLIC HEALTH SERVICE ACT 1116
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p.001115: January 30, 2020
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p.001115: (B) provider-based research networks, including health plans, facilities, or delivery system sites of care (especially
p.001115: primary care), that make extensive use of health care pro- viders who are members of health disparity populations or
p.001115: who serve patients in such populations and have the ca- pacity to evaluate and promote quality improvement;
p.001115: (C) service delivery models (such as health centers under section 330 and the Indian Health Service) to reduce
p.001115: health disparities; and
p.001115: (D) innovative mechanisms or strategies that will fa- cilitate the translation of past research
p.001115: investments into clinical practices that can reasonably be expected to ben- efit these populations.
p.001115: (c) QUALITY MEASUREMENT DEVELOPMENT.—
p.001115: (1) IN GENERAL.—To ensure that health disparity popu- lations, including minority health disparity populations,
p.001115: benefit from the progress made in the ability of individuals to measure the quality of health care delivery, the
p.001115: Director shall support the development of quality of health care measures that assess the experience of such
p.001115: populations with health care systems, such as measures that assess the access of such populations to health care,
p.001115: the cultural competence of the care provided, the quality of the care provided, the outcomes of care, or other
p.001115: as- pects of health care practice that the Director determines to be important.
p.001115: (2) EXAMINATION OF CERTAIN PRACTICES.—The Director
p.001115: shall examine the practices of providers that have a record of reducing health disparities or have experience
p.001115: in providing cul- turally competent health services to minority health disparity populations or other health
p.001115: disparity populations. In exam- ining such practices of providers funded under the authorities of this Act,
p.001115: the Director shall consult with the heads of the rel- evant agencies of the Public Health Service.
p.001115: (3) REPORT.—Not later than 36 months after the date of the enactment of this section, the Secretary, acting
p.001115: through the Director, shall prepare and submit to the appropriate commit- tees of Congress a report describing the
p.001115: state-of-the-art of qual- ity measurement for minority and other health disparity popu- lations that will identify
p.001115: critical unmet needs, the current ac- tivities of the Department to address those needs, and a de-
p.001115: scription of related activities in the private sector.
p.001115: (d) DEFINITION.—For purposes of this section:
p.001115: (1) The term ‘‘health disparity population’’ has the mean- ing given such term in section 464z–3, except that
p.001115: in addition to the meaning so given, the Director may determine that such term includes populations for which
p.001115: there is a significant dis- parity in the quality, outcomes, cost, or use of health care serv- ices or access to or
p.001115: satisfaction with such services as compared to the general population.
p.001115: (2) The term ‘‘minority’’, with respect to populations, refers to racial and ethnic minority groups as defined in
p.001115: section 1707.
p.001115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001117: 1117
p.001117: PUBLIC HEALTH SERVICE ACT
p.001117: Sec. 912
p.001117:
p.001117: PART B—HEALTH CARE IMPROVEMENT RESEARCH
p.001117: SEC. 911. ø299b¿ HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
p.001117: (a) EVIDENCE RATING SYSTEMS.—In collaboration with experts from the public and private sector, the Agency
p.001117: shall identify and disseminate methods or systems to assess health care research re- sults, particularly methods
p.001117: or systems to rate the strength of the scientific evidence underlying health care practice, recommenda-
p.001117: tions in the research literature, and technology assessments. The Agency shall make methods or systems
p.001117: for evidence rating widely available. Agency publications containing health care recommenda- tions shall indicate
p.001117: the level of substantiating evidence using such methods or systems.
p.001117: (b) HEALTH CARE IMPROVEMENT RESEARCH CENTERS AND PRO-
p.001117: VIDER-BASED RESEARCH NETWORKS.—
p.001117: (1) IN GENERAL.—In order to address the full continuum of care and outcomes research, to link research to
p.001117: practice im- provement, and to speed the dissemination of research findings to community practice settings, the
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p.001123: (A) safety, efficacy, and effectiveness;
p.001123: (B) legal, social, and ethical implications;
p.001123: (C) costs, benefits, and cost-effectiveness;
p.001123: (D) comparisons to alternate health care practices and technologies; and
p.001123: (E) requirements of Food and Drug Administration ap- proval to avoid duplication.
p.001123: (c) SPECIFIC ASSESSMENTS.—
p.001123: (1) IN GENERAL.—The Director shall conduct or support specific assessments of health care technologies and
p.001123: practices.
p.001123: (2) REQUESTS FOR ASSESSMENTS.—The Director is author- ized to conduct or support assessments, on a
p.001123: reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the
p.001123: Department of Veterans Affairs, the Office of Personnel Management, and other public or pri- vate entities.
p.001123: (3) GRANTS AND CONTRACTS.—In addition to conducting as- sessments, the Director may make grants to, or enter
p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001273: The design of any evaluation study conducted under subparagraph
p.001273: (C) shall be established prior to the commencement of the dem- onstration project under subparagraph (B) for
p.001273: which the evaluation will be conducted.
p.001273: (c)(1) In making grants and entering into contracts under this section, the Secretary shall provide for an
p.001273: equitable geographical distribution of centers established, maintained, and operated under this section and for
p.001273: the distribution of such centers among areas containing a wide range of population groups which
p.001273: exhibit incidences of diseases which are most amenable to preventive inter- vention.
p.001273: (2) The Secretary, through the Director of the Centers for Dis- ease Control and Prevention and in consultation with
p.001273: the Director of the National Institutes of Health, shall establish procedures for the appropriate peer review
p.001273: of applications for grants and contracts under this section by peer review groups composed principally of
p.001273: non-Federal experts.
p.001273: (d) For purposes of this section, the term ‘‘academic health cen- ter’’ means a school of medicine, a school of
p.001273: osteopathy, or a school of public health, as such terms are defined in section 701(4).
p.001273: (e) For the purpose of carrying out this section, there are au- thorized to be appropriated $10,000,000
p.001273: for fiscal year 1992, and such sums as may be necessary for each of the fiscal years 1993 through 2003.
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p.001273: January 30, 2020
p.001273: OFFICE OF MINORITY HEALTH
p.001273: SEC. 1707. ø300u–6¿ (a) IN GENERAL.—There is established an Office of Minority Health. The Office of Minority Health as
p.001273: existing on the date of enactment of the Patient Protection and Affordable Care Act shall be transferred to
p.001273: the Office of the Secretary in such manner that there is established in the Office of the Secretary, the Office of
p.001273: Minority Health, which shall be headed by the Deputy As- sistant Secretary for Minority Health who shall report
p.001273: directly to the Secretary, and shall retain and strengthen authorities (as in existence on such date of
p.001273: enactment) for the purpose of improving minority health and the quality of health care minorities
p.001273: receive, and eliminating racial and ethnic disparities. In carrying out this subsection, the Secretary, acting
p.001273: through the Deputy Assistant Sec- retary, shall award grants, contracts, enter into memoranda of un- derstanding,
p.001273: cooperative, interagency, intra-agency and other agreements with public and nonprofit private entities,
p.001273: agencies, as well as Departmental and Cabinet agencies and organizations, and
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
p.001273: (9) Carry out programs to improve access to health care services for individuals with limited proficiency in
p.001273: speaking the English language. Activities under the preceding sentence shall include developing and evaluating model
p.001273: projects.
p.001273: (10) Advise in matters related to the development, imple- mentation, and evaluation of health professions
p.001273: education in
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: 1275
p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
p.001275: (2) DUTIES.—The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section,
p.001275: including advice on the development of goals and specific program activi- ties under paragraphs (1) through (10)
p.001275: of subsection (b) for each racial and ethnic minority group.
p.001275: (3) CHAIR.—The chairperson of the Committee shall be se- lected by the Secretary from among the members of the voting
p.001275: members of the Committee. The term of office of the chair- person shall be 2 years.
p.001275: (4) COMPOSITION.—
p.001275: (A) The Committee shall be composed of 12 voting members appointed in accordance with subparagraph (B),
p.001275: and nonvoting, ex officio members designated in subpara- graph (C).
p.001275: (B) The voting members of the Committee shall be ap- pointed by the Secretary from among individuals who are
p.001275: not officers or employees of the Federal Government and who have expertise regarding issues of minority
p.001275: health. The racial and ethnic minority groups shall be equally rep- resented among such members.
p.001275: (C) The nonvoting, ex officio members of the Com- mittee shall be such officials of the Department of
p.001275: Health and Human Services as the Secretary determines to be ap- propriate.
p.001275: (5) TERMS.—Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall
p.001275: initially ap- point a portion of the members to terms of 1 year, 2 years, and 3 years.
p.001275: (6) VACANCIES.—If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary
p.001275: within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which the
p.001275: predecessor of such mem- ber was appointed. The vacancy shall not affect the power of the remaining members
p.001275: to execute the duties of the Com- mittee.
p.001275: (7) COMPENSATION.—Members of the Committee who are officers or employees of the United States shall serve
p.001275: without compensation. Members of the Committee who are not officers or employees of the United States shall
p.001275: receive compensation, for each day (including travel time) they are engaged in the performance of the
p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
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p.001275: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1276
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p.001275: January 30, 2020
p.001275:
p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
p.001275: the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other
p.001275: appro- priate departmental entities regarding recommendations for carrying out activities under subsection (b)(9).
p.001275: (B) HEALTH PROFESSIONS EDUCATION REGARDING HEALTH DISPARITIES.—The Deputy Assistant Secretary
p.001275: shall carry out the duties under subsection (b)(10) in col- laboration with appropriate personnel of the
p.001275: Department of Health and Human Services, other Federal agencies, and other offices, centers, and institutions,
p.001275: as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and
p.001275: Education Act of 2000.
p.001275: (2) EQUITABLE ALLOCATION REGARDING ACTIVITIES.—In car- rying out subsection (b), the Secretary shall ensure
p.001275: that serv- ices provided under such subsection are equitably allocated among all groups served under this
p.001275: section by the Secretary.
p.001275: (3) CULTURAL COMPETENCY OF SERVICES.—The Secretary shall ensure that information and services provided
p.001275: pursuant to subsection (b) are provided in the language, educational, and cultural context that is most appropriate for
p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
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p.001275: effective in improving the health of racial and ethnic mi- nority groups. Each such report shall include the
p.001275: biennial re- ports submitted under sections 201(e)(3) and 201(f)(2) for such years by the heads of the Public Health
p.001275: Service agencies.
p.001275: (2) AGENCY REPORTS.—Not later than February 1, 1999, and biennially thereafter, the heads of the Public Health
p.001275: Serv-
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001277: 1277
p.001277: PUBLIC HEALTH SERVICE ACT
p.001277: Sec. 1707A
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p.001277: ice agencies shall submit to the Deputy Assistant Secretary a report summarizing the minority health
p.001277: activities of each of the respective agencies.
p.001277: (g) DEFINITION.—For purposes of this section:
p.001277: (1) The term ‘‘racial and ethnic minority group’’ means American Indians (including Alaska Natives,
p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
p.001277: Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administra-
p.001277: tion, and the Centers for Medicare & Medicaid Services.
p.001277: (c) DIRECTOR; APPOINTMENT.—Each Office of Minority Health established in an agency listed in subsection (a) shall
p.001277: be headed by a director, with documented experience and expertise in minority health services research and
p.001277: health disparities elimination.
p.001277: (d) REFERENCES.—Except as otherwise specified, any reference in Federal law to an Office of Minority Health (in the
p.001277: Department of Health and Human Services) is deemed to be a reference to the Office of Minority Health in the Office of
p.001277: the Secretary.
p.001277: (e) FUNDING.—
p.001277: (1) ALLOCATIONS.—Of the amounts appropriated for a spec- ified agency for a fiscal year, the Secretary must designate
p.001277: an appropriate amount of funds for the purpose of carrying out ac- tivities under this section through the minority
p.001277: health office of the agency. In reserving an amount under the preceding sen- tence for a minority health
p.001277: office for a fiscal year, the Sec- retary shall reduce, by substantially the same percentage, the amount
p.001277: that otherwise would be available for each of the pro- grams of the designated agency involved.
p.001277: (2) AVAILABILITY OF FUNDS FOR STAFFING.—The purposes for which amounts made available under paragraph may be ex-
p.001277: pended by a minority health office include the costs of employ- ing staff for such office.
p.001277: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001277: Sec. 1708 PUBLIC HEALTH SERVICE ACT 1278
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p.001277: OFFICE OF ADOLESCENT HEALTH
p.001277: SEC. 1708. ø300u–7¿ (a) IN GENERAL.—There is established an Office of Adolescent Health within the Office of
p.001277: the Assistant Sec- retary for Health, which office shall be headed by a director ap- pointed by the
p.001277: Secretary. The Secretary shall carry out this section acting through the Director of such Office.
p.001277: (b) DUTIES.—With respect to adolescent health, the Secretary shall—
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p.001277: (1) coordinate all activities within the Department of Health and Human Services that relate to
p.001277: disease prevention, health promotion, preventive health services, and health infor- mation and education with
p.001277: respect to the appropriate use of health care, including coordinating—
p.001277: (A) the design of programs, support for programs, and the evaluation of programs;
p.001277: (B) the monitoring of trends;
p.001277: (C) projects of research (including multidisciplinary projects) on adolescent health; and
p.001277: (D) the training of health providers who work with adolescents, particularly nurse practitioners, physician as-
p.001277: sistants, and social workers;
p.001277: (2) coordinate the activities described in paragraph (1) with similar activities in the private sector; and
p.001277: (3) support projects, conduct research, and disseminate in- formation relating to preventive medicine, health
p.001277: promotion, and physical fitness and sports medicine.
p.001277: (c) CERTAIN DEMONSTRATION PROJECTS.—
p.001277: (1) IN GENERAL.—In carrying out subsection (b)(3), the Sec- retary may make grants to carry out demonstration projects
p.001277: for the purpose of improving adolescent health, including projects to train health care providers in
p.001277: providing services to adoles- cents and projects to reduce the incidence of violence among adolescents,
p.001277: particularly among minority males.
p.001277: (2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there are authorized to be
p.001277: appro- priated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994
p.001277: through 1997.
p.001277: (d) INFORMATION CLEARINGHOUSE.—In carrying out subsection (b), the Secretary shall establish and maintain a
p.001277: National Informa- tion Clearinghouse on Adolescent Health to collect and disseminate to health professionals and
p.001277: the general public information on ado- lescent health.
p.001277: (e) NATIONAL PLAN.—In carrying out subsection (b), the Sec- retary shall develop a national plan
p.001277: for improving adolescent health. The plan shall be consistent with the applicable objectives established
p.001277: by the Secretary for the health status of the people of the United States for the year 2000, and
p.001277: shall be periodically re- viewed, and as appropriate, revised. The plan, and any revisions in the plan, shall be
p.001277: submitted to the Committee on Energy and Com- merce of the House of Representatives and the Committee on Labor and
p.001277: Human Resources of the Senate.
p.001277: (f) ADOLESCENT HEALTH.—For purposes of this section, the term ‘‘adolescent health’’, with respect to
p.001277: adolescents of all ethnic
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p.001291: paragraphs of this subsection.
p.001291: (2) DUTIES.—A condition under paragraph (1) for a State is that the duties of the Committee are—
p.001291: (A) to hold public hearings on the State plan required in subsection (a)(2); and
p.001291: (B) to make recommendations pursuant to subsection (b)(1) regarding the development and implementation of
p.001291: such plan, including recommendations on—
p.001291: (i) the conduct of assessments of the public health;
p.001291: (ii) which of the activities authorized in section 1904 should be carried out in the State;
p.001291: (iii) the allocation of payments made to the State under section 1903;
p.001291: (iv) the coordination of activities carried out under such plan with relevant programs of other entities; and
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p.001291: (v) the collection and reporting of data in accord- ance with section 1906(a).
p.001291: (3) COMPOSITION.—
p.001291: (A) A condition under paragraph (1) for a State is that the Committee is composed of such members of the general
p.001291: public, and such officials of the health departments of po- litical subdivisions of the State, as may
p.001291: be necessary to provide adequate representation of the general public and of such health departments.
p.001291: (B) With respect to compliance with subparagraph (A), the membership of advisory committees established pursu- ant to
p.001291: subsection (c)(2) may include representatives of community-based organizations (including minority com-
p.001291: munity-based organizations), schools of public health, and entities to which the State involved awards grants or
p.001291: con- tracts to carry out activities authorized in section 1904.
p.001291: (4) CHAIR; MEETINGS.—A condition under paragraph (1) for a State is that the State public health officer
p.001291: serves as the chair of the Committee, and that the Committee meets not less than twice each fiscal year.
p.001291: REPORTS, DATA, AND AUDITS
p.001291: SEC. 1906. ø300w–5¿ (a)(1) For purposes of section 1905(c)(5)(B)(i), a State is collecting and
p.001291: reporting data for a fiscal year in accordance with this subsection if the State submits to the Secretary, not later
p.001291: than February 1 of the succeeding fiscal year, a report that—
p.001291: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001441: prevention of expo- sure to, and the transmission of, the etiologic agent for acquired immune deficiency
p.001441: syndrome.
p.001441: (b) PREFERENCES IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give
p.001441: preference to any ap- plicant for such a grant that has the ability to disseminate rapidly the information described in
p.001441: subsection (a) (including any national organization with such ability).
p.001441:
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p.001441: 4 So in law. The word ‘‘the’’ appears twice.
p.001441: 5 See footnote for section 217(a).
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p.001441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001441: Sec. 2524 PUBLIC HEALTH SERVICE ACT 1442
p.001441:
p.001441: SEC. 2524. ø300ee–34¿ AUTHORIZATION OF APPROPRIATIONS.
p.001441: (a) IN GENERAL.—For the purpose of carrying out sections 2521 through 2523, there are authorized to
p.001441: be appropriated
p.001441: $105,000,000 for fiscal year 1989 and such sums as may be nec- essary for each of the fiscal years 1990 and
p.001441: 1991.
p.001441: (b) ALLOCATIONS.—
p.001441: (1) Of the amounts appropriated pursuant to subsection (a), the Secretary shall make available $45,000,000 to
p.001441: carry out section 2522 and $30,000,000 to carry out this part through fi- nancial assistance to minority entities for
p.001441: the provision of serv- ices to minority populations.
p.001441: (2) After consultation with the Director of the Office of Mi- nority Health and with the Indian Health Service,
p.001441: the Sec- retary, acting through the Director of the Centers for Disease Control and Prevention, shall, not
p.001441: later than 90 days after the date of the enactment of the AIDS Amendments of 1988, 6 pub- lish guidelines to
p.001441: provide procedures for applications for fund- ing pursuant to paragraph (1) and for public comment.
p.001441:
p.001441: TITLE XXVI—HIV HEALTH CARE SERVICES PROGRAM 1
p.001441: PART A—EMERGENCY RELIEF FOR AREAS WITH SUBSTANTIAL NEED
p.001441: FOR SERVICES 2
p.001441: Subpart I—General Grant Provisions
p.001441: SEC. 2601. ø300ff–11¿ ESTABLISHMENT OF PROGRAM OF GRANTS.
p.001441: (a) ELIGIBLE AREAS.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001441: Administration, shall, subject to subsections (b) through (c), make grants in accord- ance with section 2603 for the
p.001441: purpose of assisting in the provision of the services specified in section 2604 in any metropolitan area for
p.001441: which there has been reported to and confirmed by the Director of the Centers for Disease Control and Prevention
p.001441: a cumulative total of more than 2,000 cases of AIDS during the most recent pe- riod of 5 calendar years for which
p.001441: such data are available.
p.001441: (b) CONTINUED STATUS AS ELIGIBLE AREA.—Notwithstanding any other provision of this section, a
p.001441: metropolitan area that is an eligible area for a fiscal year continues to be an eligible area until the
p.001441: metropolitan area fails, for three consecutive fiscal years—
p.001441:
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p.001451: Secretary shall, for purposes of this subparagraph, modify the number of such cases reported for the eligible
p.001451: area in order to ad- just for duplicative reporting in and among sys- tems that use code-based reporting.
p.001451: (II) ADJUSTMENT RATE.—The adjustment rate under subclause (I) for an eligible area shall be a reduction of 5
p.001451: percent for fiscal years before fiscal year 2012 (and 6 percent for fiscal year 2012) in the number of
p.001451: living non-AIDS cases of HIV re- ported for the area.
p.001451: (III) INCREASED ADJUSTMENT FOR CERTAIN AREAS PREVIOUSLY USING CODE-BASED REPORT- ING.—For
p.001451: purposes of this subparagraph for each of fiscal years 2010 through 2012, the Secretary shall deem the
p.001451: applicable number of living cases of HIV/AIDS in an area that were reported to and confirmed by the Centers for
p.001451: Disease Control and Prevention to be 3 percent higher than the actual number if—
p.001451: (aa) for fiscal year 2007, such area was a transitional area;
p.001451: (bb) fiscal year 2007 was the first year in which the count of living non-AIDS cases of HIV in such area, for
p.001451: purposes of this section, was based on a names-based reporting sys- tem; and
p.001451: (cc) the amount of funding that such area received under this part for fiscal year 2007 was less than 70
p.001451: percent of the amount of funding (exclusive of funds that were identi- fied as being for purposes of
p.001451: the Minority AIDS Initiative) that such area received under such part for fiscal year 2006.
p.001451: (vii) MULTIPLE POLITICAL JURISDICTIONS.—With respect to living non-AIDS cases of HIV, if an eligible area is
p.001451: not entirely within one political jurisdiction and as a result is subject to more than one reporting
p.001451: system for purposes of this subparagraph:
p.001451: (I) Names-based reporting under clause (i) ap- plies in a jurisdictional portion of the area, or an exemption
p.001451: under clause (ii) applies in such portion (subject to applicable provisions of this subpara- graph), according
p.001451: to whether names-based report- ing or code-based reporting is used in such por- tion.
p.001451: (II) If under subclause (I) both names-based reporting and code-based reporting apply in the area, the
p.001451: number of code-based cases shall be re- duced under clause (vi).
p.001451: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001451: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1452
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p.001507: are—
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001507:
p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
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p.001519: referral to and provision of specialty care; and
p.001519: (B) services that sustain program activity and con- tribute to or help improve services under
p.001519: subparagraph (A).
p.001519: (i) APPLICATION TO PRIMARY CARE SERVICES.—Nothing in this part shall be construed as requiring funds
p.001519: under this part to be used for primary care services when payments are available for such services from
p.001519: other sources (including under titles XVIII, XIX, and XXI of the Social Security Act).
p.001519: (j) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001519: to be appropriated,
p.001519: $71,800,000 for each of the fiscal years 2007 through 2009,
p.001519: $75,390,000 for fiscal year 2010, $79,160,000 for fiscal year 2011,
p.001519: $83,117,000 for fiscal year 2012, and $87,273,000 for fiscal year 2013.
p.001519:
p.001519: PART E—GENERAL PROVISIONS
p.001519:
p.001519:
p.001519:
p.001519:
p.001519:
p.001519:
p.001519:
p.001519:
p.001519:
p.001519: January 30, 2020
p.001519: SEC. 2681. ø300ff–81¿ COORDINATION.
p.001519: (a) REQUIREMENT.—The Secretary shall ensure that the Health Resources and Services Administration, the Centers
p.001519: for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the
p.001519: Centers for Medicare & Medicaid Services coordinate the planning, funding, and implementation of Federal HIV
p.001519: programs (including all minority AIDS initiatives of
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001519:
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p.001521: 1521
p.001521: PUBLIC HEALTH SERVICE ACT
p.001521: Sec. 2683
p.001521:
p.001521:
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p.001521: January 30, 2020
p.001521: the Public Health Service, including under section 2693) to enhance the continuity of care and prevention
p.001521: services for individuals with HIV/AIDS or those at risk of such disease. The Secretary shall con- sult with other
p.001521: Federal agencies, including the Department of Vet- erans Affairs, as needed and utilize planning information
p.001521: sub- mitted to such agencies by the States and entities eligible for as- sistance under this title.
p.001521: (b) REPORT.—The Secretary shall biennially prepare and sub- mit to the appropriate committees of the
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p.001527: trans- mission of the disease, including measures for the preven- tion and treatment of opportunistic infections, and
p.001527: includ- ing (as applicable to the type of health professional in- volved), prenatal and other
p.001527: gynecological care for women with HIV/AIDS;
p.001527: (B) to train the faculty of schools of, and graduate de- partments or programs of, medicine, nursing, osteopathic
p.001527: medicine, dentistry, public health, allied health, and men- tal health practice to teach health professions
p.001527: students to provide for the health care needs of individuals with HIV/ AIDS;
p.001527: (C) to develop and disseminate curricula and resource materials relating to the care and treatment of individuals with
p.001527: such disease and the prevention of the disease among individuals who are at risk of contracting the disease; and
p.001527: (D) to develop protocols for the medical care of women with HIV/AIDS, including prenatal and other gynecological care
p.001527: for such women.
p.001527: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.001527: preference to qualified projects which will—
p.001527: (A) train, or result in the training of, health profes- sionals who will provide treatment for minority
p.001527: individuals and Native Americans with HIV/AIDS and other individ- uals who are at high risk of contracting such
p.001527: disease;
p.001527: (B) train, or result in the training of, minority health professionals and minority allied health
p.001527: professionals to provide treatment for individuals with such disease; and
p.001527: (C) train or result in the training of health profes- sionals and allied health professionals to provide
p.001527: treat- ment for hepatitis B or C co-infected individuals.
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001527:
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p.001527: Sec. 2692 PUBLIC HEALTH SERVICE ACT 1528
p.001527:
p.001527: (3) APPLICATION.—No grant or contract may be made under paragraph (1) unless an application is
p.001527: submitted to the Secretary in such form, at such time, and containing such in- formation, as the Secretary
p.001527: may prescribe.
p.001527: (b) DENTAL SCHOOLS.—
p.001527: (1) IN GENERAL.—
p.001527: (A) GRANTS.—The Secretary may make grants to den- tal schools and programs described in subparagraph (B) to assist
p.001527: such schools and programs with respect to oral health care to patients with HIV/AIDS.
p.001527: (B) ELIGIBLE APPLICANTS.—For purposes of this sub- section, the dental schools and programs referred to in this
p.001527: subparagraph are dental schools and programs that were described in section 777(b)(4)(B) as such section was in
p.001527: ef- fect on the day before the date of the enactment of the Health Professions Education Partnerships
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p.001527: paragraph (1)(B) that partner with community-based dentists to provide oral health care to patients with
p.001527: HIV/AIDS in unserved areas. Such partnerships shall permit the training of dental students and residents and the
p.001527: participation of community dentists as adjunct faculty.
p.001527: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001527: (1) SCHOOLS; CENTERS.—For the purpose of awarding grants under subsection (a), there are authorized
p.001527: to be appro- priated $34,700,000 for each of the fiscal years 2007 through 2009, $36,535,000 for fiscal
p.001527: year 2010, $38,257,000 for fiscal year 2011, $40,170,000 for fiscal year 2012, and $42,178,000 for fiscal
p.001527: year 2013.
p.001527: (2) DENTAL SCHOOLS.—For the purpose of awarding grants under subsection (b), there are authorized to be
p.001527: appropriated
p.001527: $13,000,000 for each of the fiscal years 2007 through 2009,
p.001527: $13,650,000 for fiscal year 2010, $14,333,000 for fiscal year
p.001527:
p.001527:
p.001527:
p.001527: January 30, 2020
p.001527: 15 So in law. See section 402(b)(2) of Public Law 106–345 (114 Stat. 1349).
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527:
p.001529: 1529
p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
p.001529:
p.001529:
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
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p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001531: 1531
p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
p.001531:
p.001531: (1) The schedule for carrying out subsection (b)(1)(A) shall be the same as the schedule applicable to emergency
p.001531: assistance under part A.
p.001531: (2) The schedule for carrying out subsection (b)(1)(B) shall be the same as the schedule applicable to care
p.001531: grants under part B.
p.001531: (3) The schedule for carrying out subsection (b)(1)(C) shall be the same as the schedule applicable to grants
p.001531: for early intervention services under part C.
p.001531: (4) The schedule for carrying out subsection (b)(1)(D) shall be the same as the schedule applicable to grants
p.001531: for services through projects for HIV-related care under part D.
p.001531: (5) The schedule for carrying out subsection (b)(1)(E) shall be the same as the schedule applicable to grants and
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p.001665: (II) furthering interoperability throughout the health information technology infrastructure;
p.001665: (v) recommendations for addressing the gaps iden- tified in clause (iii); and
p.001665: (vi) a description of additional initiatives as the HIT Advisory Committee and National Coordinator
p.001665: determine appropriate.
p.001665: (3) SIGNIFICANT ADVANCEMENT DETERMINATION.—The Sec- retary shall periodically, based on the reports submitted under
p.001665: this subsection, review the target areas described in subsection (b)(2)(B), and, based on the objectives and
p.001665: benchmarks estab- lished under paragraph (1), the Secretary shall determine if significant advancement has
p.001665: been achieved with respect to such an area. Such determination shall be taken into consider- ation by the HIT
p.001665: Advisory Committee when determining to what extent the Committee makes recommendations for an area other
p.001665: than an area described in subsection (b)(2)(B).
p.001665: (d) MEMBERSHIP AND OPERATIONS.—
p.001665: (1) IN GENERAL.—The National Coordinator shall take a leading position in the establishment and operations
p.001665: of the HIT Advisory Committee.
p.001665: (2) MEMBERSHIP.—The membership of the HIT Advisory Committee shall—
p.001665: (A) include at least 25 members, of which—
p.001665: (i) no fewer than 2 members are advocates for pa- tients or consumers of health information technology;
p.001665: (ii) 3 members are appointed by the Secretary, 1 of whom shall be appointed to represent the Depart-
p.001665: ment of Health and Human Services and 1 of whom shall be a public health official;
p.001665: (iii) 2 members are appointed by the majority leader of the Senate;
p.001665: (iv) 2 members are appointed by the minority leader of the Senate;
p.001665: (v) 2 members are appointed by the Speaker of the House of Representatives;
p.001665: (vi) 2 members are appointed by the minority leader of the House of Representatives; and
p.001665: (vii) such other members are appointed by the Comptroller General of the United States; and
p.001665: (B) at least reflect providers, ancillary health care workers, consumers, purchasers, health plans, health
p.001665: in- formation technology developers, researchers, patients, rel- evant Federal agencies, and individuals with technical
p.001665: ex-
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001669: PUBLIC HEALTH SERVICE ACT
p.001669: Sec. 3002
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p.001669: pertise on health care quality, system functions, privacy, security, and on the electronic exchange and use of
p.001669: health information, including the use standards for such activity.
p.001669: (3) PARTICIPATION.—The members of the HIT Advisory Committee shall represent a balance among various
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p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: 1699
p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
p.001699:
p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
p.001699: activity, the Secretary shall analyze data collected under paragraph (a) to detect and monitor trends in
p.001699: health disparities (as defined for purposes of section 485E) at the Federal and State levels.
p.001699: (c) DATA REPORTING AND DISSEMINATION.—
p.001699: (1) IN GENERAL.—The Secretary shall make the analyses described in (b) available to—
p.001699: (A) the Office of Minority Health;
p.001699: (B) the National Center on Minority Health and Health Disparities;
p.001699: (C) the Agency for Healthcare Research and Quality;
p.001699: (D) the Centers for Disease Control and Prevention;
p.001699: (E) the Centers for Medicare & Medicaid Services;
p.001699: (F) the Indian Health Service and epidemiology cen- ters funded under the Indian Health Care Improvement
p.001699: Act;
p.001699: (G) the Office of Rural health;
p.001699: (H) other agencies within the Department of Health and Human Services; and
p.001699: (I) other entities as determined appropriate by the Secretary.
p.001699: (2) REPORTING OF DATA.—The Secretary shall report data and analyses described in (a) and (b) through—
p.001699: (A) public postings on the Internet websites of the De- partment of Health and Human Services; and
p.001699: (B) any other reporting or dissemination mechanisms determined appropriate by the Secretary.
p.001699: (3) AVAILABILITY OF DATA.—The Secretary may make data described in (a) and (b) available for additional research, anal-
p.001699: yses, and dissemination to other Federal agencies, non-govern- mental entities, and the public, in accordance with any
p.001699: Federal agency’s data user agreements.
p.001699: (d) LIMITATIONS ON USE OF DATA.—Nothing in this section shall be construed to permit the use of information
p.001699: collected under this section in a manner that would adversely affect any individual.
p.001699: (e) PROTECTION AND SHARING OF DATA.—
p.001699: (1) PRIVACY AND OTHER SAFEGUARDS.—The Secretary shall ensure (through the promulgation of regulations or
p.001699: otherwise) that—
p.001699: (A) all data collected pursuant to subsection (a) is pro- tected—
p.001699: (i) under privacy protections that are at least as broad as those that the Secretary applies to other
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p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: Sec. 3301 PUBLIC HEALTH SERVICE ACT 1700
p.001699:
p.001699: Accountability Act of 1996 (Public Law 104–191; 110
p.001699: Stat. 2033); and
p.001699: (ii) from all inappropriate internal use by any en- tity that collects, stores, or receives the data, including use of
p.001699: such data in determinations of eligibility (or continued eligibility) in health plans, and from other
p.001699: inappropriate uses, as defined by the Secretary; and
p.001699: (B) all appropriate information security safeguards are used in the collection, analysis, and sharing of data
p.001699: col- lected pursuant to subsection (a).
p.001699: (2) DATA SHARING.—The Secretary shall establish proce- dures for sharing data collected pursuant to
p.001699: subsection (a), measures relating to such data, and analyses of such data, with other relevant Federal
p.001699: and State agencies including the agencies, centers, and entities within the Department of Health and
p.001699: Human Services specified in subsection (c)(1)..
p.001699: (f) DATA ON RURAL UNDERSERVED POPULATIONS.—The Sec- retary shall ensure that any data collected in accordance
p.001699: with this section regarding racial and ethnic minority groups are also col- lected regarding underserved rural
p.001699: and frontier populations.
p.001699: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001699: to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.
p.001699: (h) REQUIREMENT FOR IMPLEMENTATION.—Notwithstanding any other provision of this section, data may not be collected
p.001699: under this section unless funds are directly appropriated for such purpose in an appropriations Act.
p.001699: (i) CONSULTATION.—The Secretary shall consult with the Direc- tor of the Office of Personnel Management, the
p.001699: Secretary of De- fense, the Secretary of Veterans Affairs, the Director of the Bureau of the Census, the
p.001699: Commissioner of Social Security, and the head of other appropriate Federal agencies in carrying out this
p.001699: section.
p.001699: TITLE XXXII—øREPEALED.¿
p.001699:
p.001699: øTitle XXXII of Public Health Service Act was repealed by sec- tion 642(a) of Public Law 112–240.¿
p.001699:
p.001699: TITLE XXXIII—WORLD TRADE CENTER HEALTH PROGRAM
p.001699: Subtitle A—Establishment of Program; Advisory Committee
p.001699:
p.001699:
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p.001699:
p.001699: January 30, 2020
p.001699: SEC. 3301. ø42 U.S.C. 300mm¿ ESTABLISHMENT OF WORLD TRADE CEN- TER HEALTH PROGRAM.
p.001699: (a) IN GENERAL.—There is hereby established within the De- partment of Health and Human Services a
p.001699: program to be known as the World Trade Center Health Program, which shall be admin-
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001699:
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p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
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p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: (1) the expansion of current demographic data collection and population surveillance efforts to include
p.000533: childhood cancers nationally;
p.000533: (2) the development of a uniform reporting system under which treating physicians, hospitals, clinics, and
p.000533: States report the diagnosis of childhood cancers, including relevant associ- ated epidemiological data; and
p.000533: (3) support for the National Limb Loss Information Center to address, in part, the primary and secondary needs
p.000533: of per- sons who experience childhood cancers in order to prevent or minimize the disabling nature of these
p.000533: cancers.
p.000533: (c) COORDINATION OF ACTIVITIES.—The Secretary shall assure that activities under this section are
p.000533: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities focused on
p.000533: childhood cancers and limb loss.
p.000533: (d) DEFINITION.—For purposes of this section, the term ‘‘child- hood cancer’’ refers to a spectrum of
p.000533: different malignancies that
p.000533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000533: Sec. 399O PUBLIC HEALTH SERVICE ACT 534
p.000533:
p.000533: vary by histology, site of disease, origin, race, sex, and age. The Secretary may for purposes of this
p.000533: section revise the definition of such term to the extent determined by the Secretary to be appro-
p.000533: priate.
p.000533: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000533: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000533: SEC. 399O. ø280g–3¿ PRESCRIPTION DRUG MONITORING PROGRAM.
p.000533: (a) PROGRAM.—
p.000533: (1) IN GENERAL.—Each fiscal year, the Secretary, acting through the Director of the Centers for Disease
p.000533: Control and Prevention, in coordination with the heads of other depart- ments and agencies as appropriate,
p.000533: shall support States or lo- calities for the purpose of improving the efficiency and use of PDMPs, including—
p.000533: (A) establishment and implementation of a PDMP;
p.000533: (B) maintenance of a PDMP;
p.000533: (C) improvements to a PDMP by—
p.000533: (i) enhancing functional components to work to- ward—
p.000533: (I) universal use of PDMPs among providers and their delegates, to the extent that State laws allow;
p.000533: (II) more timely inclusion of data within a PDMP;
p.000533: (III) active management of the PDMP, in part by sending proactive or unsolicited reports to pro- viders to inform
p.000533: prescribing; and
p.000533: (IV) ensuring the highest level of ease in use of and access to PDMPs by providers and their delegates,
p.000533: to the extent that State laws allow;
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p.000545: completed, the Comptroller General shall submit to Congress a report on the evaluation.
p.000545: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for the
p.000545: purpose of carrying out this section.
p.000545: SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
p.000545: (a) ESTABLISHMENT.—
p.000545: (1) IN GENERAL.—Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary,
p.000545: act- ing through the Director of the Centers for Disease Control and Prevention, may, if scientifically
p.000545: advisable—
p.000545: (A) develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as
p.000545: ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some
p.000545: cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the
p.000545: United States; and
p.000545: (B) establish a national registry for the collection and storage of such data to develop a population-based
p.000545: registry of cases in the United States of ALS and other motor neu- ron disorders that can be confused with ALS,
p.000545: misdiagnosed as ALS, and in some cases progress to ALS.
p.000545: (2) PURPOSE.—It is the purpose of the registry established under paragraph (1)(B) to—
p.000545: (A) better describe the incidence and prevalence of ALS in the United States;
p.000545: (B) examine appropriate factors, such as environ- mental and occupational, that may be associated
p.000545: with the disease;
p.000545: (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history
p.000545: of indi- viduals who are diagnosed with the disease) associated with the disease;
p.000545: (D) better examine the connection between ALS and other motor neuron disorders that can be confused with
p.000545: ALS, misdiagnosed as ALS, and in some cases progress to ALS; and
p.000545: (E) other matters as recommended by the Advisory Committee established under subsection (b).
p.000545: (b) ADVISORY COMMITTEE.—
p.000545: (1) ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the
p.000545: Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a
p.000545: committee to be known as the Ad- visory Committee on the National ALS Registry (referred to in
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000547: PUBLIC HEALTH SERVICE ACT
p.000547: Sec. 399S
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p.000549: coordination with other agencies as the Secretary determines, shall, as appro- priate—
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p.000549: (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases; and
p.000549: (2) incorporate information obtained through such activi- ties into an integrated surveillance system, which may
p.000549: consist of or include a registry, to be known as the National Neuro- logical Conditions Surveillance System.
p.000549: (b) RESEARCH.—The Secretary shall ensure that the National Neurological Conditions Surveillance System is
p.000549: designed in a man- ner that facilitates further research on neurological diseases.
p.000549: (c) CONTENT.—In carrying out subsection (a), the Secretary—
p.000549: (1) shall provide for the collection and storage of informa- tion on the incidence and prevalence of
p.000549: neurological diseases in the United States;
p.000549: (2) to the extent practicable, shall provide for the collection and storage of other available information on
p.000549: neurological dis- eases, including information related to persons living with neu- rological diseases who choose to
p.000549: participate, such as—
p.000549: (A) demographics, such as age, race, ethnicity, sex, ge- ographic location, family history, and other information, as
p.000549: appropriate;
p.000549: (B) risk factors that may be associated with neuro- logical diseases, such as genetic and environmental
p.000549: risk factors and other information, as appropriate; and
p.000549: (C) diagnosis and progression markers;
p.000549: (3) may provide for the collection and storage of informa- tion relevant to analysis on neurological
p.000549: diseases, such as in- formation concerning—
p.000549: (A) the natural history of the diseases;
p.000549: (B) the prevention of the diseases;
p.000549: (C) the detection, management, and treatment ap- proaches for the diseases; and
p.000549: (D) the development of outcomes measures;
p.000549: (4) may address issues identified during the consultation process under subsection (d); and
p.000549: (5) initially may address a limited number of neurological diseases.
p.000549: (d) CONSULTATION.—In carrying out this section, the Secretary shall consult with individuals with appropriate
p.000549: expertise, which may include—
p.000549: (1) epidemiologists with experience in disease surveillance or registries;
p.000549: (2) representatives of national voluntary health associa- tions that—
p.000549: (A) focus on neurological diseases; and
p.000549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: individuals with congenital heart disease across all ages;
p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000559: Sec. 399V–2 PUBLIC HEALTH SERVICE ACT 560
p.000559:
p.000559: (b) ACTIVITIES.—
p.000559: (1) IN GENERAL.—The Secretary shall carry out activities, including, as appropriate, through a national cohort
p.000559: study and a nationally-representative, population-based surveillance sys- tem, to improve the understanding of the
p.000559: epidemiology of con- genital heart disease in all age groups, with particular atten- tion to—
p.000559: (A) the incidence and prevalence of congenital heart disease in the United States;
p.000559: (B) causation and risk factors associated with, and natural history of, congenital heart disease;
p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
p.000559: members, and health care providers, on topics such as the prevalence of such disease, the effect of
...

p.000567: and
p.000567:
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000567:
p.000567:
p.000567:
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p.000567:
p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
p.000567: (2) PARTICULAR CANCER.—The term ‘‘particular cancer’’ means one specific type of cancer or a type of cancers
p.000567: scientif- ically proven to have the same cause.
p.000567: (3) POPULATION GROUP.—The term ‘‘population group’’ means a group, for purposes of calculating cancer
p.000567: rates, de- fined by factors such as race, ethnicity, age, or gender.
p.000567: (b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUS-
p.000567: TERS.—
p.000567: (1) DEVELOPMENT OF CRITERIA.—The Secretary shall de- velop criteria for the designation of potential
p.000567: cancer clusters.
p.000567: (2) REQUIREMENTS.—The criteria developed under para- graph (1) shall consider, as appropriate—
p.000567: (A) a standard for cancer cluster identification and re- porting protocols used to determine when cancer incidence is
p.000567: greater than would be typically observed;
p.000567: (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same
p.000567: type of cancer, or types of cancers;
p.000567: (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age,
p.000567: and gender, for purposes of calculating cancer rates;
p.000567: (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create
p.000567: or obscure a potential cluster by selection of a specific area; and
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567:
p.000567: January 30, 2020
p.000567: (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected num- ber
p.000567: of cases, occurs.
p.000567: (c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER CLUSTERS.—The Secretary, in consultation with
p.000567: the Council of State and Territorial Epidemiologists and representatives of State and local health
p.000567: departments, shall develop, publish, and periodi- cally update guidelines for investigating potential cancer
p.000567: clusters. The guidelines shall—
p.000567: (1) recommend that investigations of cancer clusters—
p.000567: (A) use the criteria developed under subsection (b);
p.000567: (B) use the best available science; and
p.000567: (C) rely on a weight of the scientific evidence;
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000567:
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p.000567:
p.000569: 569
p.000569: PUBLIC HEALTH SERVICE ACT
p.000569: Sec. 399V–6
p.000569:
...

p.000691: (9) REPORT.—Not later than 4 years after the date of en- actment of the Childhood Cancer Survivorship,
p.000691: Treatment, Ac- cess, and Research Act of 2018, the Secretary shall submit to Congress a report on—
p.000691: (A) the number of biospecimens and corresponding clinical demographic data collected through the biospeci-
p.000691: men research efforts supported under paragraph (1);
p.000691: (B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;
p.000691: (C) barriers to the collection of biospecimens and cor- responding clinical demographic data;
p.000691: (D) barriers experienced by researchers or health care professionals in accessing the biospecimens and cor-
p.000691: responding clinical demographic data necessary for use in research; and
p.000691: (E) recommendations with respect to improving the biospecimen and biorepository research efforts under this
p.000691: subsection.
p.000691: (10) DEFINITIONS.—For purposes of this subsection:
p.000691: (A) AWARD.—The term ‘‘award’’ includes a grant, con- tract, or cooperative agreement determined by the
p.000691: Sec- retary.
p.000691: (B) BIOSPECIMEN.—The term ‘‘biospecimen’’ includes—
p.000691: (i) solid tumor tissue or bone marrow;
p.000691: (ii) normal or control tissue;
p.000691: (iii) blood and plasma;
p.000691: (iv) DNA and RNA extractions;
p.000691: (v) familial DNA; and
p.000691: (vi) any other sample relevant to cancer research, as required by the Secretary.
p.000691: (C) CLINICAL AND DEMOGRAPHIC INFORMATION.—The term ‘‘clinical and demographic information’’ includes—
p.000691: (i) date of diagnosis;
p.000691: (ii) age at diagnosis;
p.000691: (iii) the patient’s sex, race, ethnicity, and environ- mental exposures;
p.000691: (iv) extent of disease at enrollment;
p.000691: (v) site of metastases;
p.000691: (vi) location of primary tumor coded;
p.000691: (vii) histologic diagnosis;
p.000691: (viii) tumor marker data when available;
p.000691: (ix) treatment and outcome data;
p.000691: (x) information related to specimen quality; and
p.000691: (xi) any other applicable information required by the Secretary.
p.000691: (b) IMPROVING CARE FOR PEDIATRIC CANCER SURVIVORS.—
p.000691: (1) RESEARCH ON PEDIATRIC CANCER SURVIVORSHIP.—The Director of NIH, in coordination with ongoing
p.000691: research activi- ties, may continue to conduct or support pediatric cancer survi- vorship research including in any of
p.000691: the following areas:
p.000691: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000691:
p.000691:
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p.000691:
p.000693: 693
p.000693: PUBLIC HEALTH SERVICE ACT
p.000693: Sec. 417F
p.000693:
p.000693:
p.000693:
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...

p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
p.000787: national research institutes. Information from the data sys- tem shall be available through information systems
p.000787: available to health care professionals and providers, researchers, and members of the public.
p.000787: (2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental
p.000787: treatments that have been developed for research on women’s health. Such registry shall include information on subject
p.000787: eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal
p.000787: investigators of such clinical trials shall provide this information to the registry within 30 days after it is avail-
p.000787: able. Once a trial has been completed, the principal investi- gator shall provide the registry with
p.000787: information pertaining to the results, including potential toxicities or adverse effects as- sociated with the
p.000787: experimental treatment or treatments evalu- ated.
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000787:
p.000787:
p.000787:
p.000787:
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p.000787:
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p.000789: 789
p.000789: PUBLIC HEALTH SERVICE ACT
p.000789: Sec. 487
p.000789:
p.000789: (b) CLEARINGHOUSE.—The Director of NIH, in consultation with the Director of the Office and with
p.000789: the National Library of Medicine, shall establish, maintain, and operate a program to pro- vide information on
p.000789: research and prevention activities of the na- tional research institutes that relate to research on
p.000789: women’s health.
p.000789: SEC. 486B. ø287d–2¿ BIENNIAL REPORT.
p.000789: (a) IN GENERAL.—With respect to research on women’s health, the Director of the Office shall, not later than
p.000789: February 1, 1994, and biennially thereafter, prepare a report—
p.000789: (1) describing and evaluating the progress made during the preceding 2 fiscal years in research and
p.000789: treatment con- ducted or supported by the National Institutes of Health;
...

p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000803:
p.000803:
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p.000803:
p.000803:
p.000805: 805
p.000805: PUBLIC HEALTH SERVICE ACT
p.000805: Sec. 493
p.000805:
p.000805: (2) CONTENTS.—Each triennial report prepared by an advi- sory council of each national research institute as described
p.000805: in paragraph (1) shall include each of the following:
p.000805: (A) The number of women included as subjects, and the proportion of subjects that are women, in any
p.000805: project of clinical research conducted during the applicable report- ing period, disaggregated by categories of
p.000805: research area, condition, or disease, and accounting for single-sex studies.
p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
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p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
p.000805:
p.000805: January 30, 2020
p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
...

p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
p.000905: amount in an amount greater than the amount the person is authorized to receive.
p.000905: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.000905: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.000905: for not more than 5 years, or both.
p.000905: SEC. 533. ø290cc–33¿ NONDISCRIMINATION.
p.000905: (a) IN GENERAL.—
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000905:
p.000905:
p.000905:
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p.000905:
p.000905:
p.000907: 907
p.000907: PUBLIC HEALTH SERVICE ACT
p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.000907: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.000907: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.000907: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.000907: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section
p.000907: 521 shall be considered to be programs and activities receiving Federal fi- nancial assistance.
p.000907: (2) PROHIBITION.—No person shall on the ground of sex or religion be excluded from participation in, be denied the
p.000907: bene- fits of, or be subjected to discrimination under, any program or activity funded in whole or in part with
p.000907: funds made available under section 521.
p.000907: (b) ENFORCEMENT.—
p.000907: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.000907: entity that has received a payment pursuant to section 521, has failed to comply with a provision of law
p.000907: referred to in subsection (a)(1), with subsection (a)(2), or with an applicable regulation (includ- ing one prescribed
p.000907: to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the State and shall re-
p.000907: quest the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days,
p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
...

p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
p.000933: restrictive, most normative environment that is clinically appropriate; and
p.000933: (E) provide outreach services to inform individuals, as appropriate, of the services available from the system,
p.000933: in- cluding identifying children with a serious emotional dis- turbance who are in the early stages of
p.000933: such disturbance.
p.000933: (3) RULE OF CONSTRUCTION.—An agreement made under paragraph (2) may not be construed—
p.000933: (A) with respect to subparagraph (C) of such para- graph—
p.000933:
p.000933:
p.000933:
p.000933:
p.000933:
p.000933: January 30, 2020
p.000933: (i) to prohibit a system of care under subsection
p.000933: (a) from requiring that, in housing provided by the grantee for purposes of residential treatment
p.000933: services authorized under subsection (c), males and females be
p.000933: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: Sec. 563 PUBLIC HEALTH SERVICE ACT 934
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p.001077:
p.001077:
p.001077:
p.001077:
p.001077:
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p.001077:
p.001077:
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p.001077:
p.001077: January 30, 2020
p.001077: SEC. 799. ø295o–1¿ GENERALLY APPLICABLE PROVISIONS.
p.001077: (a) AWARDING OF GRANTS AND CONTRACTS.—The Secretary shall ensure that grants and contracts under this title
p.001077: are awarded on a competitive basis, as appropriate, to carry out innovative dem- onstration projects or provide for
p.001077: strategic workforce supplemen- tation activities as needed to meet health workforce goals and in
p.001077: accordance with this title. Contracts may be entered into under this title with public or private entities as
p.001077: may be necessary.
p.001077: (b) ELIGIBLE ENTITIES.—Unless specifically required otherwise in this title, the Secretary shall accept
p.001077: applications for grants or contracts under this title from health professions schools, academic health centers,
p.001077: State or local governments, or other appropriate public or private nonprofit entities for funding and
p.001077: participation in health professions and nursing training activities. The Secretary may accept applications
p.001077: from for-profit private entities if deter- mined appropriate by the Secretary.
p.001077: (c) INFORMATION REQUIREMENTS.—
p.001077: (1) IN GENERAL.—Recipients of grants and contracts under this title shall meet information requirements as
p.001077: specified by the Secretary.
p.001077: (2) DATA COLLECTION.—The Secretary shall establish pro- cedures to ensure that, with respect to any data
p.001077: collection re- quired under this title, such data is collected in a manner that takes into account age, sex, race, and
p.001077: ethnicity.
p.001077: (3) USE OF FUNDS.—The Secretary shall establish proce- dures to permit the use of amounts appropriated
p.001077: under this title to be used for data collection purposes.
p.001077: (4) EVALUATIONS.—The Secretary shall establish proce- dures to ensure the annual evaluation of
p.001077: programs and projects operated by recipients of grants or contracts under this title. Such procedures shall
p.001077: ensure that continued funding for such programs and projects will be conditioned upon a dem- onstration
p.001077: that satisfactory progress has been made by the pro- gram or project in meeting the objectives of the program
p.001077: or project.
p.001077: (d) TRAINING PROGRAMS.—Training programs conducted with amounts received under this title shall meet
p.001077: applicable accredita- tion and quality standards.
p.001077: (e) DURATION OF ASSISTANCE.—
p.001077: (1) IN GENERAL.—Subject to paragraph (2), in the case of an award to an entity of a grant, cooperative
p.001077: agreement, or contract under this title, the period during which payments are made to the entity under the
p.001077: award may not exceed 5 years. The provision of payments under the award shall be subject to annual approval by the
p.001077: Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the
p.001077: payments. This paragraph may not be construed as limiting the number of awards under the program involved that
p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
...

p.001293: examination, copying, or mechanical reproduction on or off the premises of the appropriate entity upon a
p.001293: reasonable request therefor.
p.001293: (d)(1) In conducting any investigation in a State, the Secretary or the Comptroller General of the United States
p.001293: may not make a request for any information not readily available to such State or an entity which has
p.001293: received funds from an allotment made to the State under this part or make an unreasonable request for infor-
p.001293: mation to be compiled, collected, or transmitted in any form not readily available.
p.001293: (2) Paragraph (1) does not apply to the collection, compilation, or transmittal of data in the course of a judicial
p.001293: proceeding.
p.001293:
p.001293:
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p.001293:
p.001293:
p.001293:
p.001293: January 30, 2020
p.001293: NONDISCRIMINATION
p.001293: SEC. 1908. ø300w–7¿ (a)(1) For the purpose of applying the prohibitions against discrimination on the
p.001293: basis of age under the Age Discrimination Act of 1975, on the basis of handicap under sec- tion 504 of the
p.001293: Rehabilitation Act of 1973, on the basis of sex under title IX of the Education Amendments of 1972, or on the
p.001293: basis of race, color, or national origin under title VI of the Civil Rights Act of 1964, programs and activities
p.001293: funded in whole or in part with funds made available under this part are considered to be pro- grams
p.001293: and activities receiving Federal financial assistance.
p.001293: (2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits
p.001293: of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds
p.001293: made available under this part.
p.001293: (b) Whenever the Secretary finds that a State, or an entity that has received a payment from an
p.001293: allotment to a State under section 1902, has failed to comply with a provision of law referred to in subsection
p.001293: (a)(1), with subsection (a)(2), or with an applicable regulation (including one prescribed to carry out subsection
p.001293: (a)(2)), the Secretary shall notify the chief executive officer of the State and shall request him to secure
p.001293: compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer
p.001293: fails or refuses to secure compliance, the Secretary may—
p.001293: (1) refer the matter to the Attorney General with a rec- ommendation that an appropriate civil action be
p.001293: instituted,
p.001293: (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964, the Age
p.001293: Discrimination Act of 1975, or section 504 of the Rehabilitation Act of 1973, as may be applicable, or
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p.001331: to be made any false statement or representation of a material fact in connection with the furnishing of
p.001331: items or services for which payments may be made by a State from a grant made to the State under section
p.001331: 1911 or 1921.
p.001331: (2) CONCEALING OR FAILING TO DISCLOSE CERTAIN EVENTS.—A person with knowledge of the
p.001331: occurrence of any event affecting the initial or continued right of the person to receive any payments from
p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
p.001331: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.001331: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.001331: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.001331: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
p.001331:
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p.001331: Sec. 1948 PUBLIC HEALTH SERVICE ACT 1332
p.001331:
p.001331: whole or in part with funds made available under section 1911 or 1921.
p.001331: (b) ENFORCEMENT.—
p.001331: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
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p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001665:
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p.001697: January 30, 2020
p.001697: SEC. 3101. ø300kk¿ DATA COLLECTION, ANALYSIS, AND QUALITY.
p.001697: (a) DATA COLLECTION.—
p.001697: (1) IN GENERAL.—The Secretary shall ensure that, by not later than 2 years after the date of enactment of this
p.001697: title, any federally conducted or supported health care or public health program, activity or survey (including
p.001697: Current Population Sur- veys and American Community Surveys conducted by the Bu-
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
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p.001697: January 30, 2020
p.001697:
p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: 1699
p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
p.001699:
p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
p.001699: activity, the Secretary shall analyze data collected under paragraph (a) to detect and monitor trends in
p.001699: health disparities (as defined for purposes of section 485E) at the Federal and State levels.
p.001699: (c) DATA REPORTING AND DISSEMINATION.—
p.001699: (1) IN GENERAL.—The Secretary shall make the analyses described in (b) available to—
p.001699: (A) the Office of Minority Health;
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p.000017: agencies and with State and local health depart- ments and agencies. For such purpose he shall utilize
p.000017: insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to
p.000017: section 3709 of the Revised Stat- utes (41 U.S.C. 5), of any appropriate State or other public agency, and may,
p.000017: without regard to such section, utilize the services or fa- cilities of any private agency, organization, group, or
p.000017: individual, in accordance with written agreements between the head of such agency, organization, or group
p.000017: and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities
p.000017: shall be made in such amounts as may be provided in such agreement.
p.000017: (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health
p.000017: data, the Secretary shall prepare and distribute suitable and necessary forms for the collec- tion and compilation
p.000017: of such data.
p.000017: (h)(1) There shall be an annual collection of data from the records of births, deaths, marriages, and
p.000017: divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and
p.000017: municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in
p.000017: necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data
p.000017: on ethnic and racial populations, including subpopulations of Hispanics, Asian Ameri- cans, and Pacific
p.000017: Islanders with significant representation in the State or registration area. Each State or registration area shall
p.000017: be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and
p.000017: transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such
p.000017: data.
p.000017: (2) There shall be an annual collection of data from a statis- tically valid sample concerning the general
p.000017: health, illness, and dis- ability status of the civilian noninstitutionalized population. Spe- cific topics to
p.000017: be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and
p.000017: accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations,
p.000017: and the relationship between de- mographic and socioeconomic characteristics and health character- istics.
p.000017: (i) The Center may provide to public and nonprofit private en- tities technical assistance in the effective use
p.000017: in such activities of statistics collected or compiled by the Center.
p.000017: (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section,
p.000017: the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and
p.000017: Human Services by—
p.000017:
p.000017:
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p.000017: January 30, 2020
p.000017: 4 So in law. Probably should be capitalized.
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p.000017: implementation of part C of title XI of the Social Security Act.
p.000017: (6) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek
p.000017: the advice of, the Com- mittee and other appropriate professional advisory groups.
p.000017: (7) Not later than 1 year after the date of the enactment of the Health Insurance Portability and Accountability
p.000017: Act of 1996, and annually thereafter, the Committee shall submit to the Congress, and make public, a report
p.000017: regarding the implementation of part C of title XI of the Social Security Act. Such report shall address the following
p.000017: subjects, to the extent that the Committee determines ap- propriate:
p.000017: (A) The extent to which persons required to comply with part C of title XI of the Social Security Act are
p.000017: cooperating in implementing the standards adopted under such part.
p.000017: (B) The extent to which such entities are meeting the secu- rity standards adopted under such part and the
p.000017: types of pen- alties assessed for noncompliance with such standards.
p.000017: (C) Whether the Federal and State Governments are re- ceiving information of sufficient quality to meet
p.000017: their respon- sibilities under such part.
p.000017: (D) Any problems that exist with respect to implementa- tion of such part.
p.000017: (E) The extent to which timetables under such part are being met.
p.000017: (l) In carrying out this section, the Secretary, acting through the Center, shall collect and analyze
p.000017: adequate health data that is specific to particular ethnic and racial populations, including data collected
p.000017: under national health surveys. Activities carried out under this subsection shall be in addition
p.000017: to any activities carried out under subsection (m).
p.000017: (m)(1) The Secretary, acting through the Center, may make grants to public and nonprofit private entities for—
p.000017: (A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations;
p.000017: (B) analysis of data on ethnic and racial populations and subpopulations; and
p.000017: (C) research on improving methods for developing statis- tics on ethnic and racial populations and
p.000017: subpopulations.
p.000017: (2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to
p.000017: grantees sup- ported by this subsection in order to maximize the data quality and comparability with other studies.
p.000017: (3) Provisions of section 308(d) do not apply to surveys or stud- ies conducted by grantees under this subsection
p.000017: unless the Sec- retary, in accordance with regulations the Secretary may issue, de- termines that such provisions
p.000017: are necessary for the conduct of the survey or study and receives adequate assurance that the grantee
p.000017: will enforce such provisions.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 85 PUBLIC HEALTH SERVICE ACT Sec. 307
p.000017:
p.000017: (4)(A) Subject to subparagraph (B), the Secretary, acting through the Center, shall collect data on
p.000017: Hispanics and major His- panic subpopulation groups and American Indians, and for devel- oping special area
p.000017: population studies on major Asian American and Pacific Islander populations.
p.000017: (B) The provisions of subparagraph (A) shall be effective with respect to a fiscal year only to the
p.000017: extent that funds are appro- priated pursuant to paragraph (3) of subsection (n), and only if the amounts
p.000017: appropriated for such fiscal year pursuant to each of para- graphs (1) and (2) of subsection (n) equal or
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p.000107: Sec. 317B PUBLIC HEALTH SERVICE ACT 108
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p.000107: January 30, 2020
p.000107:
p.000107: (1) IN GENERAL.—Not later than May 1 of each year, the Secretary shall submit to the Congress a report
p.000107: on the effec- tiveness during the preceding fiscal year of programs carried out with grants under subsection
p.000107: (a) and of any programs that are carried out by the Secretary pursuant to subsection (l)(2).
p.000107: (2) CERTAIN REQUIREMENTS.—Each report under para- graph (1) shall include, in addition to any other
p.000107: information that the Secretary may require, the following information:
p.000107: (A) The number of infants and children screened.
p.000107: (B) Demographic information on the population of in- fants and children screened, including the age and
p.000107: racial or ethnic status of such population.
p.000107: (C) The number of screening sites.
p.000107: (D) A description of the severity of the extent of the blood lead levels of the infants and children
p.000107: screened, ex- pressed in categories of severity.
p.000107: (E) The sources of payment for the screenings.
p.000107: (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from
p.000107: laboratories and health care providers to State and local health departments.
p.000107: (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if
p.000107: any, provided in the report under paragraph (1) preceding the report involved.
p.000107: (k) INDIAN TRIBES.—For purposes of this section, the term ‘‘po- litical subdivision’’ includes Indian tribes.
p.000107: (l) FUNDING.—
p.000107: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000107: be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years
p.000107: 1994 through 2005.
p.000107: (2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts appropriated under paragraph (1) for any fiscal year,
p.000107: the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities
p.000107: described in subsection (a) in addition to the program of grants established in such sub- section.
p.000107: (m) GUIDELINES FOR STANDARDIZED REPORTING.—The Sec- retary, acting through the Director of the Centers for
p.000107: Disease Con- trol and Prevention, shall develop national guidelines for the uni- form reporting of all
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p.000109: Sec. 317C PUBLIC HEALTH SERVICE ACT 110
p.000109: of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and
p.000109: Commerce of the House of Representa- tives, a report that summarizes the findings made as a result of such
p.000109: review and that contains the rec- ommendations of the Task Force on the programs and policies with respect to
p.000109: which the Task Force is estab- lished, including related budgetary recommendations; and
p.000109: (vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning
p.000109: prevention activities of the Federal Govern- ment.
p.000109: (b) TECHNOLOGY ASSESSMENT AND EPIDEMIOLOGY.—The Sec- retary, acting through the Director of the Centers for
p.000109: Disease Con- trol and Prevention, shall, directly or through grants or contracts—
p.000109: (1) provide for the development of improved, more cost-ef- fective testing measures for detecting lead toxicity
p.000109: in children;
p.000109: (2) provide for the development of improved methods of as- sessing the prevalence of lead poisoning, including such
p.000109: meth- ods as may be necessary to conduct individual assessments for each State;
p.000109: (3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and
p.000109: children, on the de- mographic characteristics of infants and children with such poisoning (including racial
p.000109: and ethnic status), and on the source of payment for treatment for such poisoning (including the
p.000109: extent to which insurance has paid for such treatment); and
p.000109: (4) provide for any applied research necessary to improve the effectiveness of programs for the
p.000109: prevention of lead poi- soning in infants and children.
p.000109: NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES
p.000109: SEC. 317C. ø247b–4¿ (a) IN GENERAL.—
p.000109: (1) NATIONAL CENTER.—There is established within the Centers for Disease Control and Prevention a center
p.000109: to be known as the National Center on Birth Defects and Develop- mental Disabilities (referred to in this
p.000109: section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease
p.000109: Control and Prevention.
p.000109: (2) GENERAL DUTIES.—The Secretary shall carry out pro- grams—
p.000109:
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p.000109: January 30, 2020
p.000109: (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and
p.000109: disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the
p.000109: causes of such de- fects and disabilities and on the incidence and prevalence of such defects and disabilities;
p.000109: (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention
p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111: January 30, 2020
p.000111:
p.000111: (B) With respect to a request described in subpara- graph (A), the Secretary shall reduce the amount of
p.000111: pay- ments under the award involved by an amount equal to the costs of detailing personnel and the
p.000111: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall,
p.000111: for the payment of ex- penses incurred in complying with such request, expend the amounts withheld.
p.000111: (3) APPLICATION FOR AWARD.—The Secretary may make an award of a grant or contract under paragraph (1) only if an ap-
p.000111: plication for the award is submitted to the Secretary and the application is in such form, is made in such
p.000111: manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be necessary to
p.000111: carry out the purposes for which the award is to be made.
p.000111: (c) BIENNIAL REPORT.—Not later than February 1 of fiscal year 1999 and of every second such year thereafter, the
p.000111: Secretary shall submit to the Committee on Commerce of the House of Representa- tives, and the Committee on Labor
p.000111: and Human Resources of the Senate, a report that, with respect to the preceding 2 fiscal years—
p.000111: (1) contains information regarding the incidence and prev- alence of birth defects, developmental
p.000111: disabilities, and the health status of individuals with disabilities and the extent to which these conditions
p.000111: have contributed to the incidence and prevalence of infant mortality and affected quality of life;
p.000111: (2) contains information under paragraph (1) that is spe- cific to various racial and ethnic groups
p.000111: (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans);
p.000111: (3) contains an assessment of the extent to which various approaches of preventing birth defects,
p.000111: developmental disabil- ities, and secondary health conditions among individuals with disabilities have been
p.000111: effective;
p.000111: (4) describes the activities carried out under this section;
p.000111: (5) contains information on the incidence and prevalence of individuals living with birth defects and disabilities or
p.000111: develop- mental disabilities, information on the health status of individ- uals with disabilities, information on any
p.000111: health disparities ex- perienced by such individuals, and recommendations for im- proving the health and
p.000111: wellness and quality of life of such indi- viduals;
p.000111: (6) contains a summary of recommendations from all birth defects research conferences sponsored by the Centers for Dis-
p.000111: ease Control and Prevention, including conferences related to spina bifida; and
p.000111: (7) contains any recommendations of the Secretary regard- ing this section.
p.000111: (d) APPLICABILITY OF PRIVACY LAWS.—The provisions of this section shall be subject to the requirements of
p.000111: section 552a of title 5, United States Code. All Federal laws relating to the privacy of information shall
p.000111: apply to the data and information that is col- lected under this section.
p.000111: (e) ADVISORY COMMITTEE.—Notwithstanding any other provi- sion of law, the members of the advisory
p.000111: committee appointed by
p.000111: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000111:
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p.000289: funded under the Maternal and Child Health Block Grant.
p.000289: (d) RULE OF CONSTRUCTION.—Except to the extent inconsistent with this section, this section may not be construed as
p.000289: affecting the authority of the Secretary to make modifications in the program carried out under subsection
p.000289: (a).
p.000289: (e) FUNDING.—
p.000289: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000289: be appro- priated—
p.000289: (A) $120,000,000 for fiscal year 2008; and
p.000289: (B) for each of fiscal years 2009 through 2013, the amount authorized for the preceding fiscal year
p.000289: increased by the percentage increase in the Consumer Price Index for all urban consumers for such year.
p.000289: (2) ALLOCATION.—
p.000289: (A) PROGRAM ADMINISTRATION.—Of the amounts ap- propriated under paragraph (1) for a fiscal year, the Sec-
p.000289: retary may reserve up to 5 percent for coordination, dis- semination, technical assistance, and data
p.000289: activities that are determined by the Secretary to be appropriate for car- rying out the program under this section.
p.000289: (B) EVALUATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve
p.000289: up to 1 percent for evaluations of projects carried out under subsection (a). Each such evaluation shall
p.000289: include a determination of whether such projects have been effective in reducing the disparity in health status between
p.000289: the gen- eral population and individuals who are members of racial or ethnic minority groups.
p.000289: SEC. 330I. ø254c–14¿ TELEHEALTH NETWORK AND TELEHEALTH RE- SOURCE CENTERS GRANT PROGRAMS.
p.000289: (a) DEFINITIONS.—In this section:
p.000289: (1) DIRECTOR; OFFICE.—The terms ‘‘Director’’ and ‘‘Office’’ mean the Director and Office specified in subsection
p.000289: (c).
p.000289: (2) FEDERALLY QUALIFIED HEALTH CENTER AND RURAL HEALTH CLINIC.—The term ‘‘Federally qualified
p.000289: health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in section 1861(aa) of the
p.000289: Social Security Act (42 U.S.C. 1395x(aa)).
p.000289: (3) FRONTIER COMMUNITY.—The term ‘‘frontier community’’ shall have the meaning given the term in regulations
p.000289: issued under subsection (r).
p.000289: (4) MEDICALLY UNDERSERVED AREA.—The term ‘‘medically underserved area’’ has the meaning given the term
p.000289: ‘‘medically underserved community’’ in section 799B(6).
p.000289: (5) MEDICALLY UNDERSERVED POPULATION.—The term ‘‘medically underserved population’’ has the meaning given
p.000289: the term in section 330(b)(3).
p.000289: (6) TELEHEALTH SERVICES.—The term ‘‘telehealth services’’ means services provided through telehealth technologies.
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000289:
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p.000291: PUBLIC HEALTH SERVICE ACT
p.000291: Sec. 330I
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p.000449: (J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement
p.000449: and al- location,
p.000449: (K) work actively to increase the supply of donated organs,
p.000449: (L) submit to the Secretary an annual report containing in- formation on the comparative costs and patient
p.000449: outcomes at
p.000449: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000449:
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p.000449: Sec. 373 PUBLIC HEALTH SERVICE ACT 450
p.000449:
p.000449: each transplant center affiliated with the organ procurement and transplantation network,
p.000449: (M) 81 recognize the differences in health and in organ transplantation issues between children and
p.000449: adults throughout the system and adopt criteria, polices, and pro- cedures that address the unique health care needs of
p.000449: chil- dren,
p.000449: (N) 81 carry out studies and demonstration projects for the purpose of improving procedures for organ donation
p.000449: procurement and allocation, including but not limited to projects to examine and attempt to increase
p.000449: transplan- tation among populations with special needs, including children and individuals who are members of
p.000449: racial or eth- nic minority groups, and among populations with limited access to transportation, and
p.000449: (O) 81 provide that for purposes of this paragraph, the term ‘‘children’’ refers to individuals who are under the age
p.000449: of 18.
p.000449: (3) CLARIFICATION.—In adopting and using standards of quality under paragraph (2)(E), the Organ Procurement
p.000449: and Transplantation Network may adopt and use such standards with respect to organs infected with human
p.000449: immunodeficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards ensure
p.000449: that organs infected with HIV may be transplanted only into individuals who—
p.000449: (A) are infected with HIV before receiving such organ;
p.000449: and
p.000449: (B)(i) are participating in clinical research approved by
p.000449: an institutional review board under the criteria, standards, and regulations described in subsections (a) and (b) of
p.000449: sec- tion 377E; or
p.000449: (ii) if the Secretary has determined under section 377E(c) that participation in such clinical
p.000449: research, as a requirement for such transplants, is no longer warranted, are receiving a transplant under the
p.000449: standards and regula- tions under section 377E(c).
p.000449: (c) The Secretary shall establish procedures for—
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p.000459: (1) the appropriate timing of such consent; and
p.000459: (2) the information provided to the maternal donor regard- ing all of her medically appropriate cord blood options.
p.000459: Based on such examination, the Secretary shall require that the standards used by the accreditation entities
p.000459: recognized under sub- section (b) ensure that a cord blood unit is acquired with the in- formed consent of
p.000459: the maternal donor.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000459: Sec. 379 PUBLIC HEALTH SERVICE ACT 460
p.000459:
p.000459: (d) FUNCTIONS.— 84
p.000459: (1) BONE MARROW FUNCTIONS.—With respect to bone mar- row, the Program shall—
p.000459: (A) operate a system for identifying, matching, and fa- cilitating the distribution of bone marrow that is
p.000459: suitably matched to candidate patients;
p.000459: (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care
p.000459: professionals, and patients to search by means of electronic access all available bone marrow donors listed in
p.000459: the Program;
p.000459: (C) carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including
p.000459: with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed
p.000459: ances- try) in the enrollment of the Program;
p.000459: (D) maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000459: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000459: January 30, 2020
p.000459:
p.000459: ‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
p.000459: ‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller General of the
p.000459: United States shall conduct a study of the National Bone Marrow Donor Registry under section 379 of the Public
p.000459: Health Service Act for purposes of making determinations of the following:
p.000459: ‘‘(1) The extent to which, relative to the effective date of this Act, such Registry has in- creased
p.000459: the representation of racial and ethnic minority groups (including persons of mixed ancestry) among potential donors
p.000459: of bone marrow who are enrolled with the Registry, and whether the extent of increase results in a level of
p.000459: representation that meets the standard established in subsection (c)(1)(A) of such section 379 (as added by section
p.000459: 2(c) of this Act). ‘‘(2) The extent to which patients in need of a transplant of bone marrow from a
p.000459: bio- logically unrelated donor, and the physicians of such patients, have been utilizing the Reg-
p.000459: istry in the search for such a donor.
p.000459: ‘‘(3) The number of such patients for whom the Registry began a preliminary search but for whom the full search
p.000459: process was not completed, and the reasons underlying such cir- cumstances.
p.000459: ‘‘(4) The extent to which the plan required in section 2(b)(2) of this Act (relating to the
p.000459: relationship between the Registry and donor centers) has been implemented.
p.000459: ‘‘(5) The extent to which the Registry, donor centers, donor registries, collection centers, transplant
p.000459: centers, and other appropriate entities have been complying with the standards, criteria, and procedures under
p.000459: subsection (e) of such section 379 (as redesignated by section 2(c) of this Act).
p.000459: ‘‘(b) REPORT.—A report describing the findings of the study under subsection (a) shall be sub- mitted to the Congress
p.000459: not later than October 1, 2001. The report may not be submitted before January 1, 2001.’’.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000463: with the Pro- gram. In the case of populations that are identified under the preceding sentence:
p.000463: (A) The Program shall give priority to carrying out ac- tivities under this part to increase representation for such
p.000463: populations in order to enable a member of such a popu-
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000463: Sec. 379 PUBLIC HEALTH SERVICE ACT 464
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p.000463: January 30, 2020
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p.000463: lation, to the extent practicable, to have a probability of finding a suitable unrelated donor that is
p.000463: comparable to the probability that an individual who is not a member of an underrepresented population would have.
p.000463: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000463: to be populations that have been identified for purposes of this paragraph, and shall carry out
p.000463: subparagraph (A) with re- spect to such populations.
p.000463: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND ENROLLMENT.—
p.000463: (A) IN GENERAL.—The Program shall carry out infor- mational and educational activities, in coordination
p.000463: with organ donation public awareness campaigns operated through the Department of Health and Human
p.000463: Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll
p.000463: with the Program potential bone marrow donors. Such information and edu- cational activities shall include the
p.000463: following:
p.000463: (i) Making information available to the general public, including information describing the needs of
p.000463: patients with respect to donors of bone marrow.
p.000463: (ii) Educating and providing information to indi- viduals who are willing to serve as potential bone mar- row
p.000463: donors.
p.000463: (iii) Training individuals in requesting individuals to serve as potential bone marrow donors.
p.000463: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000463: Pro- gram shall give priority to recruiting individuals to serve as donors of bone marrow for populations
p.000463: that are identi- fied under paragraph (1).
...

p.000465: (5) standards that—
p.000465: (A) require the establishment of a system of strict con- fidentiality to protect the identity and privacy of
p.000465: patients and donors in accordance with Federal and State law; and
p.000465: (B) prescribe the purposes for which the records de- scribed in subparagraph (A) may be disclosed, and the cir-
p.000465: cumstances and extent of the disclosure; and
p.000465: (6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure
p.000465: the establishment of a method for integrating donor files, searches, and general procedures of the center or
p.000465: registry with the Pro- gram.
p.000465: (g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
p.000465: EDUCATION.—
p.000465: (1) RECRUITMENT; PRIORITIES.—The Program shall support activities, in cooperation with qualified cord blood
p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
p.000465:
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p.000465:
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p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: recommendations of the Task Force, ensuring ade- quate staff resources, and assistance to those
p.000553: organizations re- questing it for implementation of Guide recommendations.
p.000553: (d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE.— The Task Force shall take appropriate steps to coordinate
p.000553: its work with the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices,
p.000553: including the examination of how each task force’s recommendations interact at the nexus of clinic and
p.000553: community.
p.000553: (e) OPERATION.—In carrying out the duties under subsection (b), the Task Force shall not be subject to the
p.000553: provisions of Appen- dix 2 of title 5, United States Code.
p.000553: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary
p.000553: for each fiscal year to carry out the activities of the Task Force.
p.000553: SEC. 399V. ø280g–11¿ GRANTS TO PROMOTE POSITIVE HEALTH BEHAV- IORS AND OUTCOMES.
p.000553: (a) GRANTS AUTHORIZED.—The Director of the Centers for Dis- ease Control and Prevention, in collaboration with
p.000553: the Secretary, shall award grants to eligible entities to promote positive health behaviors and outcomes
p.000553: for populations in medically underserved communities through the use of community health workers.
p.000553: (b) USE OF FUNDS.—Grants awarded under subsection (a) shall be used to support community health workers—
p.000553: (1) to educate, guide, and provide outreach in a community setting regarding health problems prevalent in
p.000553: medically un- derserved communities, particularly racial and ethnic minority populations;
p.000553: (2) to educate and provide guidance regarding effective strategies to promote positive health behaviors and
p.000553: discourage risky health behaviors;
p.000553: (3) to educate and provide outreach regarding enrollment in health insurance including the Children’s Health
p.000553: Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act and
p.000553: Medicaid under title XIX of such Act;
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: PUBLIC HEALTH SERVICE ACT
p.000555: Sec. 399V
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p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
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p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: January 30, 2020
p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
...

p.000595: entity with a privately funded wellness pro- gram requests such an evaluation.
p.000595: SEC. 399MM–3. ø280l–3¿ PROHIBITION OF FEDERAL WORKPLACE WELLNESS REQUIREMENTS.
p.000595: Notwithstanding any other provision of this part, any rec- ommendations, data, or assessments carried out
p.000595: under this part shall not be used to mandate requirements for workplace wellness programs.
p.000595:
p.000595: PART V—PROGRAMS RELATING TO BREAST HEALTH AND CANCER
p.000595:
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p.000595: January 30, 2020
p.000595: SEC. 399NN. ø280m¿ YOUNG WOMEN’S BREAST HEALTH AWARENESS AND SUPPORT OF YOUNG WOMEN DIAGNOSED WITH
p.000595: BREAST CANCER.
p.000595: (a) PUBLIC EDUCATION CAMPAIGN.—
p.000595: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000595: shall conduct a national evidence-based education campaign to in- crease awareness of young women’s knowledge
p.000595: regarding—
p.000595: (A) breast health in young women of all racial, ethnic, and cultural backgrounds;
p.000595: (B) breast awareness and good breast health habits;
p.000595: (C) the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk
p.000595: for breast cancer based on familial, racial, ethnic, and cul- tural backgrounds such as Ashkenazi Jewish
p.000595: populations;
p.000595: (D) evidence-based information that would encourage young women and their health care professional to in-
p.000595: crease early detection of breast cancers; and
p.000595: (E) the availability of health information and other re- sources for young women diagnosed with breast cancer.
p.000595: (2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The campaign shall provide evidence-based, age-appropriate
p.000595: mes- sages and materials as developed by the Centers for Disease Control and Prevention and the Advisory
p.000595: Committee estab- lished under paragraph (4).
p.000595: (3) MEDIA CAMPAIGN.—In conducting the education cam- paign under paragraph (1), the Secretary shall award grants
p.000595: to entities to establish national multimedia campaigns oriented to young women that may include advertising through
p.000595: television, radio, print media, billboards, posters, all forms of existing and especially emerging social networking
p.000595: media, other Internet
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000595:
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p.000609: 3.
p.000609: (f) There shall be in the National Institutes of Health an Asso- ciate Director for Prevention. The Director of NIH
p.000609: shall delegate to the Associate Director for Prevention the functions of the Director relating to the
p.000609: promotion of the disease prevention research pro- grams of the national research institutes and the
p.000609: coordination of such programs among the national research institutes and between the national research institutes
p.000609: and other public and private enti- ties, including elementary, secondary, and post-secondary schools. The
p.000609: Associate Director shall—
p.000609: (1) annually review the efficacy of existing policies and techniques used by the national research institutes
p.000609: to dissemi- nate the results of disease prevention and behavioral research programs; and
p.000609: (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to
p.000609: ensure max- imum dissemination, using advanced technologies to the max- imum extent practicable, of research
p.000609: results to such entities. ø(g) Transferred to section 461, redesignated as subsection (b)
p.000609: of such section, and amended (as so redesignated) by section 221(b)(5) of division F of Public Law
p.000609: 112–74.¿
p.000609: (h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of
p.000609: Health, shall, in conducting and supporting programs for research, research training, recruitment, and
p.000609: other activities, provide for an increase in the number of women and individuals from disadvantaged back- grounds
p.000609: (including racial and ethnic minorities) in the fields of bio- medical and behavioral research.
p.000609: (i)(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a
p.000609: data bank of information on clinical trials for drugs for serious or life-threatening diseases
p.000609:
p.000609:
p.000609:
p.000609:
p.000609: January 30, 2020
p.000609: 3 So in law. That Act was repealed by section 251(a)(2) of Public Law 105–220 (112 Stat. 1079).
p.000609: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000609:
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p.000609: Sec. 402 PUBLIC HEALTH SERVICE ACT 610
p.000609:
p.000609: and conditions (in this subsection referred to as the ‘‘data bank’’). The activities of the data bank shall
p.000609: be integrated and coordinated with related activities of other agencies of the Department of Health and Human
p.000609: Services, and to the extent practicable, coordi- nated with other data banks containing similar information.
p.000609: (B) The Secretary shall establish the data bank after consulta- tion with the Commissioner of Food and Drugs, the
p.000609: directors of the appropriate agencies of the National Institutes of Health (including the National Library of
p.000609: Medicine), and the Director of the Centers for Disease Control and Prevention.
p.000609: (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the
...

p.000667:
p.000667:
p.000667: January 30, 2020
p.000667: agnosis, early and ongoing detection, prevention, and treat- ment of autism spectrum disorder across the
p.000667: lifespan. The cen- ters, as a group, shall conduct research including the fields of developmental
p.000667: neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral
p.000667: psychology, and clinical psychology.
p.000667: (3) SERVICES FOR PATIENTS.—
p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
p.000667: samples.
...

p.000671: other relevant agencies.
p.000671: (B) DIRECTOR OF NIH.—The Chair of the Committee shall be directly responsible to the Director of NIH.
p.000671: (c) PLAN FOR NIH ACTIVITIES.—
p.000671: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Coordinating
p.000671: Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases
p.000671: through the national research institutes and shall periodically review and revise the plan. The plan shall—
p.000671: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000671: psychosocial, and rehabilitative issues, including studies of the dispropor- tionate impact of such diseases on
p.000671: women;
p.000671: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000671: regarding such diseases; and
p.000671: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000671: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to autoimmune diseases,
p.000671: provide for the following as appropriate:
p.000671: (A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
p.000671: (B) Basic research concerning the etiology and causes of the diseases.
p.000671: (C) Epidemiological studies to address the frequency and natural history of the diseases, including any
p.000671: dif- ferences among the sexes and among racial and ethnic groups.
p.000671: (D) The development of improved screening tech- niques.
p.000671: (E) Clinical research for the development and evalua- tion of new treatments, including new biological agents.
p.000671: (F) Information and education programs for health care professionals and the public.
p.000671: (3) IMPLEMENTATION OF PLAN.—The Director of NIH shall ensure that programs and activities of the National
p.000671: Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph
p.000671: (1).
p.000671: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000671:
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p.000671: Sec. 409F PUBLIC HEALTH SERVICE ACT 672
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p.000671: January 30, 2020
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p.000671: MUSCULAR DYSTROPHY RESEARCH
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p.000705: HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN
p.000705: SEC. 424A. ø285b–7a¿ (a) IN GENERAL.—The Director of the Institute shall expand, intensify, and coordinate
p.000705: research and re- lated activities of the Institute with respect to heart attack, stroke, and other cardiovascular
p.000705: diseases in women.
p.000705: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate activities under
p.000705: subsection (a) with similar activities conducted by the other national research insti- tutes and agencies
p.000705: of the National Institutes of Health to the ex- tent that such Institutes and agencies have
p.000705: responsibilities that are related to heart attack, stroke, and other cardiovascular dis- eases in women.
p.000705: (c) CERTAIN PROGRAMS.—In carrying out subsection (a), the Di- rector of the Institute shall conduct or support research
p.000705: to expand the understanding of the causes of, and to develop methods for pre- venting, cardiovascular diseases in
p.000705: women. Activities under such subsection shall include conducting and supporting the following:
p.000705: (1) Research to determine the reasons underlying the prev- alence of heart attack, stroke, and other
p.000705: cardiovascular dis- eases in women, including African-American women and other women who are members of racial
p.000705: or ethnic minority groups.
p.000705: (2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
p.000705: (3) Epidemiological studies to address the frequency and natural history of such diseases and the
p.000705: differences among men and women, and among racial and ethnic groups, with re- spect to such diseases.
p.000705: (4) The development of safe, efficient, and cost-effective di- agnostic approaches to evaluating women with
p.000705: suspected ischemic heart disease.
p.000705: (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
p.000705: (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women,
p.000705: including appli- cations of effective methods for the control of blood pressure, lipids, and obesity.
p.000705: (7) Information and education programs for patients and health care providers on risk factors associated
p.000705: with heart at- tack, stroke, and other cardiovascular diseases in women, and on the importance of the
p.000705: prevention or control of such risk fac-
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
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p.000705: Sec. 424B PUBLIC HEALTH SERVICE ACT 706
p.000705:
p.000705: tors and timely referral with appropriate diagnosis and treat- ment. Such programs shall include
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p.000719: Sec. 441A PUBLIC HEALTH SERVICE ACT 720
p.000719:
p.000719: LUPUS
p.000719: SEC. 441A. ø285d–6a¿ (a) IN GENERAL.—The Director of the Institute shall expand and intensify research and
p.000719: related activities of the Institute with respect to lupus.
p.000719: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000719: the Director under subsection (a) with similar activities conducted by the other na- tional research
p.000719: institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000719: respon- sibilities that are related to lupus.
p.000719: (c) PROGRAMS FOR LUPUS.—In carrying out subsection (a), the Director of the Institute shall conduct or
p.000719: support research to ex- pand the understanding of the causes of, and to find a cure for, lupus.
p.000719: Activities under such subsection shall include conducting and supporting the following:
p.000719: (1) Research to determine the reasons underlying the ele- vated prevalence of lupus in women, including
p.000719: African-Amer- ican women.
p.000719: (2) Basic research concerning the etiology and causes of the disease.
p.000719: (3) Epidemiological studies to address the frequency and natural history of the disease and the
p.000719: differences among the sexes and among racial and ethnic groups with respect to the disease.
p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
p.000719:
p.000719:
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
...

p.000733: commence a study for the purpose of providing information on the general health and well-being of
p.000733: adolescents in the United States, including, with re- spect to such adolescents, information on—
p.000733: (1) the behaviors that promote health and the behaviors that are detrimental to health; and
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000733:
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p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
p.000735: monitor the sub- jects throughout the period of the study to determine the health status of the
p.000735: subjects and any change in such status over time.
p.000735: (2) POPULATION-SPECIFIC ANALYSES.—The study required in subsection (a) shall be conducted with respect to
p.000735: the popu- lation of adolescents who are female, the population of adoles- cents who are male, various
p.000735: socioeconomic populations of ado- lescents, and various racial and ethnic populations of adoles- cents. The
p.000735: study shall be designed and conducted in a manner sufficient to provide for a valid analysis of whether there
p.000735: are significant differences among such populations in health status and whether and to what extent any such
p.000735: differences are due to factors particular to the populations involved.
p.000735: (c) COORDINATION WITH WOMEN’S HEALTH INITIATIVE.—With respect to the national study of women being conducted
p.000735: by the Sec- retary and known as the Women’s Health Initiative, the Secretary shall ensure that such study is
p.000735: coordinated with the component of the study required in subsection (a) that concerns adolescent fe- males,
p.000735: including coordination in the design of the 2 studies.
p.000735:
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p.000735: January 30, 2020
p.000735: FRAGILE X
p.000735: SEC. 452E. ø285g–9¿ (a) EXPANSION AND COORDINATION OF RE-
p.000735: SEARCH ACTIVITIES.—The Director of the Institute, after consulta- tion with the advisory council for the
p.000735: Institute, shall expand, inten- sify, and coordinate the activities of the Institute with respect to research
p.000735: on the disease known as fragile X.
p.000735: (b) RESEARCH CENTERS.—
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p.000759: (1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral research on minority health
p.000759: con- ditions (as defined in paragraph (2)), including research to pre- vent, diagnose, and treat such conditions.
p.000759: (2) The term ‘‘minority health conditions’’, with respect to individuals who are members of minority
p.000759: groups, means all diseases, disorders, and conditions (including with respect to mental health and substance
p.000759: abuse)—
p.000759: (A) unique to, more serious, or more prevalent in such individuals;
p.000759: (B) for which the factors of medical risk or types of medical intervention may be different for such
p.000759: individuals, or for which it is unknown whether such factors or types are different for such individuals; or
p.000759: (C) with respect to which there has been insufficient research involving such individuals as subjects or
p.000759: insuffi- cient data on such individuals.
p.000759: (3) The term ‘‘minority group’’ has the meaning given the term ‘‘racial and ethnic minority group’’ in section
p.000759: 1707.
p.000759: (4) The terms ‘‘minority’’ and ‘‘minorities’’ refer to individ- uals from a minority group.
p.000759: (d) HEALTH DISPARITY POPULATIONS.—For purposes of this subpart:
p.000759:
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p.000759: January 30, 2020
p.000759: (1) A population is a health disparity population if, as de- termined by the Director of the Institute after
p.000759: consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant
p.000759: disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the
p.000759: population as compared to the health status of the general population.
p.000759: (2) The Director shall give priority consideration to deter- mining whether minority groups qualify as
p.000759: health disparity populations under paragraph (1).
p.000759: (3) The term ‘‘health disparities research’’ means basic, clinical, and behavioral research on health
p.000759: disparity popu- lations (including individual members and communities of such populations) that relates to health
...

p.000785: (1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the
p.000785: Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘‘Coordinating
p.000785: Committee’’).
p.000785: (2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the
p.000785: senior-level staff designees of the Directors).
p.000785: (3) The Director of the Office shall serve as the chair of the Coordinating Committee.
p.000785: (4) With respect to research on women’s health, the Co- ordinating Committee shall assist the Director
p.000785: of the Office in—
p.000785:
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p.000785: January 30, 2020
p.000785: (A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to
p.000785: ade- quately support the research;
p.000785: (B) identifying needs regarding the coordination of re- search activities, including intramural and
p.000785: extramural multidisciplinary activities;
p.000785: (C) supporting the development of methodologies to determine the circumstances in which obtaining data
p.000785: spe- cific to women (including data relating to the age of women and the membership of women in
p.000785: ethnic or racial
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000787: 787
p.000787: PUBLIC HEALTH SERVICE ACT
p.000787: Sec. 486
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p.000787: January 30, 2020
p.000787: groups) is an appropriate function of clinical trials of treat- ments and therapies;
p.000787: (D) supporting the development and expansion of clin- ical trials of treatments and therapies for which obtaining such
p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
p.000787: Advi- sory Committee on Research on Women’s Health (in this sub- section referred to as the ‘‘Advisory
p.000787: Committee’’).
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p.000787:
p.000787: (iii) the level of funding needed for such research.
p.000787: (B) The report required in subparagraph (A) shall be sub- mitted to the Director of NIH for inclusion
p.000787: in the report re- quired in section 403.
p.000787: (e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The Secretary, acting through the Assistant Secretary for
p.000787: Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are
p.000787: represented among senior physi- cians and scientists of the national research institutes and among
p.000787: physicians and scientists conducting research with funds provided by such institutes, and as appropriate,
p.000787: carry out activities to in- crease the extent of such representation.
p.000787: (f) DEFINITIONS.—For purposes of this part:
p.000787: (1) The term ‘‘women’s health conditions’’, with respect to women of all age, ethnic, and racial groups, means
p.000787: all diseases, disorders, and conditions (including with respect to mental health)—
p.000787: (A) unique to, more serious, or more prevalent in women;
p.000787: (B) for which the factors of medical risk or types of medical intervention are different for women, or for
p.000787: which it is unknown whether such factors or types are different for women; or
p.000787: (C) with respect to which there has been insufficient clinical research involving women as subjects or
p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
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p.000789: bio- medical and behavioral research;
p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
p.000789: (C) provide contracts for scholarships and loan repayments in accordance with sections 487D and 487E, subject
p.000789: to pro- viding not more than an aggregate 50 such contracts during the fiscal years 1994 through 1996.
p.000789: A reference in this subsection to the National Institutes of Health shall be considered to include the
p.000789: institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the
p.000789: Administration, 53 as the case may be.
p.000789: (2) Ruth L. Kirschstein National Research Service Awards may not be used to support residency training of
p.000789: physicians and other health professionals.
p.000789: (3) In awarding Ruth L. Kirschstein National Research Service Awards under this section, the Secretary shall take
p.000789: account of the Nation’s overall need for biomedical research personnel by giving special consideration to
p.000789: physicians who agree to undertake a min- imum of two years of biomedical research.
p.000789: (4) The Secretary shall carry out paragraph (1) in a manner that will result in the recruitment of women, and
p.000789: individuals from disadvantaged backgrounds (including racial and ethnic minori- ties), into fields of
p.000789: biomedical or behavioral research and in the provision of research training to women and such individuals.
p.000789: (b)(1) No Ruth L. Kirschstein National Research Service Award may be made by the Secretary to any individual unless—
p.000789: (A) the individual has submitted to the Secretary an appli- cation therefor and the Secretary has approved the
p.000789: application;
p.000789: (B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe,
p.000789: assurances satis- factory to the Secretary that the individual will meet the serv- ice requirement of subsection (c);
p.000789: and
p.000789: (C) in the case of a Ruth L. Kirschstein National Research Service Award for a purpose described in
p.000789: subsection (a)(1)(A)(iii), the individual has been sponsored (in such man- ner as the Secretary may by
p.000789: regulation require) by the institu- tion at which the research or training under the award will be conducted.
p.000789: An application for an award shall be in such form, submitted in such manner, and contain such
p.000789: information, as the Secretary may by regulation prescribe.
p.000789: (2) The making of grants under subsection (a)(1)(B) for Ruth
p.000789: L. Kirschstein National Research Service Awards shall be subject to review and approval by the appropriate
p.000789: advisory councils within the Department of Health and Human Services (A) whose activities relate to the research or
p.000789: training under the awards, or (B) for the entity at which such research or training will be conducted.
p.000789: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000789:
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p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
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p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
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p.000981: calculating a repayment schedule;
p.000981: (E) offers, in accordance with criteria prescribed by regulation by the Secretary, a schedule for
p.000981: repayment of principal and interest under which payment of a portion of the principal and interest otherwise
p.000981: payable at the begin- ning of the repayment period (as defined in such regula- tions) is deferred until a
p.000981: later time in the period;
p.000981: (F) entitles the borrower to accelerate without penalty repayment of the whole or any part of the loan;
p.000981: (G) provides that the check for the proceeds of the loan shall be made payable jointly to the borrower and the eligi-
p.000981: ble institution in which the borrower is enrolled; and
p.000981: (H) contains such other terms and conditions con- sistent with the provisions of this subpart and with
p.000981: the regulations issued by the Secretary pursuant to this sub- part, as may be agreed upon by the
p.000981: parties to such loan, including, if agreed upon, a provision requiring the bor- rower to pay to the lender,
p.000981: in addition to principal and in- terest, amounts equal to the insurance premiums payable by the lender to
p.000981: the Secretary with respect to such loan; and
p.000981: (3) subject to the consent of the student and subject to ap- plicable law, the eligible lender has obtained from the
p.000981: student appropriate demographic information regarding the student, including racial or ethnic background.
p.000981: (b) LIMITATION ON RATE OF INTEREST.—The rate of interest prescribed and defined by the Secretary for the
p.000981: purpose of sub- section (a)(2)(D) may not exceed the average of the bond equivalent rates of the 91-day Treasury
p.000981: bills auctioned for the previous quar-
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p.000981: 1 So in law. Probably should include another closing parenthesis.
p.000981: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000981: Sec. 706 PUBLIC HEALTH SERVICE ACT 982
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p.000981: January 30, 2020
p.000981:
p.000981: ter plus 3 percentage points, rounded to the next higher one-eighth of 1 percent.
p.000981: (c) MINIMUM ANNUAL PAYMENT BY BORROWER.—The total of the payments by a borrower during any year or any
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p.001005: 1005
p.001005: PUBLIC HEALTH SERVICE ACT
p.001005: Sec. 724
p.001005:
p.001005: (1) any Federal capital contribution made to the student loan fund of the school from such amounts,
p.001005: together with the school contribution appropriate under subsection (b)(2)(B) of such section to the amount of
p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
p.001005: (2) collections of principal and interest on loans made pur- suant to paragraph (1), and any other earnings of the
p.001005: student loan fund attributable to amounts that are in the fund pursu- ant to such paragraph, will be utilized only for
p.001005: the purpose de- scribed in such paragraph.
p.001005: (b) MINIMUM QUALIFICATIONS FOR SCHOOLS.—The Secretary may not make a Federal capital contribution for
p.001005: purposes of sub- section (a) for a fiscal year unless the health professions school in- volved—
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p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
p.001005: (2) with respect to health clinics providing services to a significant number of individuals who are
p.001005: from disadvantaged backgrounds, including members of minority groups, to enter into arrangements with 1 or more
p.001005: such clinics for the purpose of providing students of the school with experience in providing clinical services to such
p.001005: individuals;
p.001005: (3) with respect to public or nonprofit private secondary educational institutions and undergraduate
p.001005: institutions of higher education, to enter into arrangements with 1 or more such institutions for the
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p.001009: encouraging under-represented minority students from all levels of the educational pipeline to pursue health
p.001009: professions careers; and
p.001009: (iv) has made significant recruitment efforts to in- crease the number of under-represented minority indi- viduals
p.001009: serving in faculty or administrative positions at the school.
p.001009: (C) CONSORTIUM.—The condition specified in this sub- paragraph is that, in accordance with subsection (e)(1), the
p.001009: designated health profession school involved has with other health profession schools (designated or
p.001009: otherwise) formed a consortium to carry out the purposes described in subsection (b) at the schools of the consortium.
p.001009: (D) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Secretary
p.001009: for purposes of determining whether schools meet the condi- tions described in subparagraph (B), this section
p.001009: may not,
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
p.001011: (A) CONDITIONS.—The conditions specified in this sub- paragraph are that a designated health professions
p.001011: school—
p.001011: (i) is a school described in section 799B(1); and
p.001011: (ii) received a contract under section 788B for fis- cal year 1987, as such section was in effect for such
p.001011: fiscal year.
p.001011: (B) USE OF GRANT.—In addition to the purposes de- scribed in subsection (b), a grant under subsection
p.001011: (a) to a designated health professions school meeting the condi- tions described in subparagraph (A) may be
p.001011: expended—
p.001011: (i) to develop a plan to achieve institutional im- provements, including financial independence, to en-
p.001011: able the school to support programs of excellence in health professions education for under-represented mi-
p.001011: nority individuals; and
p.001011: (ii) to provide improved access to the library and informational resources of the school.
p.001011: (C) EXCEPTION.—The requirements of paragraph (1)(C) shall not apply to a historically black college or university that
p.001011: receives funding under paragraphs (2) or (5) 7.
p.001011: (3) HISPANIC CENTERS OF EXCELLENCE.—The conditions specified in this paragraph are that—
p.001011: (A) with respect to Hispanic individuals, each of clauses (i) through (iv) of paragraph (1)(B)
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p.001015: unless the health professions and nursing schools involved agree that, in pro- viding scholarships pursuant to the
p.001015: grant, the schools will give preference to students for whom the costs of attending the schools would constitute
p.001015: a severe financial hardship and, notwithstanding other provisions of this section, to former recipients of
p.001015: scholarships under sections 736 and 740(d)(2)(B) (as such sections existed on the day before the date of enactment of
p.001015: this section).
p.001015: (c) AMOUNT OF AWARD.—In awarding grants to eligible entities that are health professions and nursing schools, the
p.001015: Secretary shall give priority to eligible entities based on the proportion of grad- uating students going
p.001015: into primary care, the proportion of under- represented minority students, and the proportion of graduates
p.001015: working in medically underserved communities.
p.001015: (d) DEFINITIONS.—In this section:
p.001015: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means an entity that—
p.001015: (A) is a school of medicine, osteopathic medicine, den- tistry, nursing (as defined in section 801),
p.001015: pharmacy, podiatric medicine, optometry, veterinary medicine, public health, chiropractic, or allied health,
p.001015: a school offering a graduate program in behavioral and mental health prac- tice, or an entity providing
p.001015: programs for the training of physician assistants; and
p.001015: (B) is carrying out a program for recruiting and retain- ing students from disadvantaged backgrounds, including
p.001015: students who are members of racial and ethnic minority groups.
p.001015: (2) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who—
p.001015: (A) is from a disadvantaged background;
p.001015: (B) has a financial need for a scholarship; and
p.001015: (C) is enrolled (or accepted for enrollment) at an eligi- ble health professions or nursing school as a full-time stu-
p.001015: dent in a program leading to a degree in a health profes- sion or nursing.
p.001015: SEC. 738. ø293b¿ LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY POSITIONS.
p.001015: (a) LOAN REPAYMENTS.—
p.001015: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program of entering into contracts with
p.001015: individuals described in paragraph (2) under which the individuals agree to serve as members of the
p.001015: faculties of schools described in paragraph (3) in consideration of the Federal Government agreeing
p.001015: to pay, for each year of such service, not more than
p.001015: $30,000 of the principal and interest of the educational loans of such individuals.
p.001015: (2) ELIGIBLE INDIVIDUALS.—The individuals referred to in paragraph (1) are individuals from disadvantaged
p.001015: backgrounds who—
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p.001019: PUBLIC HEALTH SERVICE ACT
p.001019: Sec. 739
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p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
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p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
p.001019: common objectives with institutions of higher education, school dis- tricts, and other community-based entities.
p.001019: (2) Such formal agreements shall reflect the coordination of educational activities and support services,
p.001019: increased link- ages, and the consolidation of resources within a specific geo- graphic area.
p.001019: (3) The design of the educational activities involved shall provide for the establishment of a
p.001019: competitive health profes- sions applicant pool of individuals from disadvantaged back- grounds by enhancing
p.001019: the total preparation (academic and so- cial) of such individuals to pursue a health professions career.
p.001019: (4) The programs or activities under the award shall focus on developing a culturally competent health care
p.001019: workforce that will serve the unserved and underserved populations within the geographic area.
p.001019: (c) EQUITABLE ALLOCATION OF FINANCIAL ASSISTANCE.—The Secretary, to the extent practicable, shall ensure that
p.001019: services and activities under subsection (a) are adequately allocated among the various racial and ethnic
p.001019: populations who are from disadvantaged backgrounds.
p.001019: (d) MATCHING REQUIREMENTS.—The Secretary may require that an entity that applies for a grant or contract
p.001019: under subsection (a), provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of
p.001019: the entity to the projects funded
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: PUBLIC HEALTH SERVICE ACT
p.001021: Sec. 741
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p.001021: January 30, 2020
p.001021: under the grant or contract. As determined by the Secretary, such non-Federal matching funds may be provided
p.001021: directly or through donations from public or private entities and may be in cash or in- kind, fairly evaluated,
p.001021: including plant, equipment, or services.
p.001021: SEC. 740. ø293d¿ AUTHORIZATION OF APPROPRIATION.
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p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
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p.001060: SEC. 765. ø295¿ GENERAL PROVISIONS.
p.001060: (a) IN GENERAL.—The Secretary may award grants or contracts to eligible entities to increase the number of individuals
p.001060: in the pub- lic health workforce, to enhance the quality of such workforce, and to enhance the ability of the workforce
p.001060: to meet national, State, and local health care needs.
p.001060: (b) ELIGIBILITY.—To be eligible to receive a grant or contract under subsection (a) an entity shall—
p.001060: (1) be—
p.001060: (A) a health professions school, including an accredited school or program of public health, health
p.001060: administration, preventive medicine, or dental public health or a school providing health management programs;
p.001060: (B) an academic health center;
p.001060: (C) a State or local government; or
p.001060: (D) any other appropriate public or private nonprofit entity; and
p.001060: (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such
p.001060: information as the Secretary may require.
p.001060: (c) PREFERENCE.—In awarding grants or contracts under this section the Secretary may grant a preference to
p.001060: entities—
p.001060: (1) serving individuals who are from disadvantaged back- grounds (including underrepresented racial and
p.001060: ethnic minori- ties); and
p.001060: (2) graduating large proportions of individuals who serve in underserved communities.
p.001060: (d) ACTIVITIES.—Amounts provided under a grant or contract awarded under this section may be used for—
p.001060: (1) the costs of planning, developing, or operating dem- onstration training programs;
p.001060: (2) faculty development;
p.001060: (3) trainee support;
p.001060: (4) technical assistance;
p.001060: (5) to meet the costs of projects—
p.001060: (A) to plan and develop new residency training pro- grams and to maintain or improve existing
p.001060: residency training programs in preventive medicine and dental pub- lic health, that have available full-time
p.001060: faculty members with training and experience in the fields of preventive medicine and dental public health;
p.001060: and
p.001060: (B) to provide financial assistance to residency train- ees enrolled in such programs;
p.001060: (6) the retraining of existing public health workers as well as for increasing the supply of new practitioners to
p.001060: address pri- ority public health, preventive medicine, public health den- tistry, and health administration
p.001060: needs;
p.001060: (7) preparing public health professionals for employment at the State and community levels;
p.001060: (8) public health workforce loan repayment programs; or
p.001060: (9) other activities that may produce outcomes that are consistent with the purposes of this section.
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p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001077: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001077: title that relates to the period during which payments may be made under the award.
p.001077: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001077: Sec. 799A PUBLIC HEALTH SERVICE ACT 1078
p.001077:
p.001077: (f) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001077: (1) IN GENERAL.—Each application for a grant under this title, except any scholarship or loan program,
p.001077: including those under sections 23 701, 721, or 723, shall be submitted to a peer review group for an evaluation
p.001077: of the merits of the proposals made in the application. The Secretary may not approve such an
p.001077: application unless a peer review group has recommended the application for approval.
p.001077: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001077: are not officers or employees of the Federal Government. In pro- viding for the establishment of peer
p.001077: review groups and proce- dures, the Secretary shall ensure sex, racial, ethnic, and geo- graphic balance
p.001077: among the membership of such groups.
p.001077: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001077: Administrator of the Health Resources and Services Administration.
p.001077: (g) PREFERENCE OR PRIORITY CONSIDERATIONS.—In considering a preference or priority for funding which is
p.001077: based on outcome measures for an eligible entity under this title, the Secretary may also consider the
p.001077: future ability of the eligible entity to meet the outcome preference or priority through improvements in
p.001077: the eligi- ble entity’s program design.
p.001077: (h) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001077: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001077: analysis activities under section 761; and
p.001077: (2) discipline-specific workforce information and analytical activities are carried out as part of—
p.001077: (A) the community-based linkage program under part D; and
p.001077: (B) the health workforce development program under subpart 2 of part E.
p.001077: (i) OSTEOPATHIC SCHOOLS.—For purposes of this title, any ref- erence to—
p.001077: (1) medical schools shall include osteopathic medical schools; and
p.001077: (2) medical students shall include osteopathic medical stu- dents.
p.001077: SEC. 799A. ø295o–2¿ TECHNICAL ASSISTANCE.
p.001077: Funds appropriated under this title may be used by the Sec- retary to provide technical assistance in
p.001077: relation to any of the au- thorities under this title.
p.001077: SEC. 799B. ø295p¿ DEFINITIONS.
p.001077: For purposes of this title:
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p.001081: (A) is eligible for designation under section 332 as a health professional shortage area;
p.001081: (B) is eligible to be served by a migrant health center under section 329 25, a community health center under sec- tion
p.001081: 330 25, a grantee under section 330(h) (relating to homeless individuals), or a grantee under section
p.001081: 340A 25 (relating to residents of public housing);
p.001081: (C) has a shortage of personal health services, as de- termined under criteria issued by the Secretary under
p.001081: sec- tion 1861(aa)(2) of the Social Security Act (relating to rural health clinics); or
p.001081: (D) is designated by a State Governor (in consultation with the medical community) as a shortage area or medi-
p.001081: cally underserved community.
p.001081: (7) The term ‘‘Department’’ means the Department of Health and Human Services.
p.001081: (8) The term ‘‘nonprofit’’ refers to the status of an entity owned and operated by one or more
p.001081: corporations or associa- tions no part of the net earnings of which inures, or may law- fully inure, to the
p.001081: benefit of any private shareholder or indi- vidual.
p.001081: (9) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.001081: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.001081: American Samoa, and the Trust Territory of the Pacific Islands.
p.001081: (10)(A) Subject to subparagraph (B), the term ‘‘underrep- resented minorities’’ means, with respect to a
p.001081: health profes- sion, racial and ethnic populations that are underrepresented in the health profession
p.001081: relative to the number of individuals who are members of the population involved.
p.001081: (B) For purposes of subparagraph (A), Asian individuals shall be considered by the various subpopulations of
p.001081: such indi- viduals.
p.001081: (11) The term ‘‘psychologist’’ means an individual who—
p.001081: (A) holds a doctoral degree in psychology; and
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p.001081: 25 The reference in paragraph (6)(B) to section 329 refers to section 329 of the Act of July 1, 1944,
p.001081: which was omitted in the general amendment of subpart I of part D of this title by section 2 of Public Law 104-299
p.001081: (110 Stat. 3626; October 11, 1996). Section 340A, referred to in para- graph (6)(B), was repealed by section
p.001081: 4(a)(3) of Public Law 104-299.
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p.001081: (B) is licensed or certified on the basis of the doctoral degree in psychology, by the State in which the individual
p.001081: practices, at the independent practice level of psychology to furnish diagnostic, assessment, preventive,
p.001081: and thera- peutic services directly to individuals.
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p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
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p.001083: 26 Effective on July 1, 2015, section 512(z)(3) of Public Law 113–128 provides for an amend- ment to
p.001083: strike ‘‘one-stop delivery system described in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C.
p.001083: 2864(c))’’ and insert ‘‘one-stop delivery system described in section 121(e) of the Workforce Innovation and
p.001083: Opportunity Act’’.
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p.001087: may be made to the entity.
p.001087: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001087: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001087: title that relates to the period during which payments may be made under the award.
p.001087: (e) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001087: (1) IN GENERAL.—Each application for a grant under this title, except advanced nurse traineeship grants
p.001087: under section 811(a)(2), shall be submitted to a peer review group for an evaluation of the merits of
p.001087: the proposals made in the applica- tion. The Secretary may not approve such an application un- less a
p.001087: peer review group has recommended the application for approval.
p.001087: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001087: are
p.001087: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001087: Sec. 807 PUBLIC HEALTH SERVICE ACT 1088
p.001087:
p.001087: not officers or employees of the Federal Government. In pro- viding for the establishment of peer review
p.001087: groups and proce- dures, the Secretary shall, except as otherwise provided, en- sure sex, racial, ethnic,
p.001087: and geographic representation among the membership of such groups.
p.001087: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001087: Administrator of the Health Resources and Services Administration.
p.001087: (f) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001087: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001087: analysis activities under this title; and
p.001087: (2) discipline-specific workforce information is developed and analytical activities are carried out as part of—
p.001087: (A) the advanced education nursing activities under part B;
p.001087: (B) the workforce diversity activities under part C;
p.001087: and
p.001087: (C) basic nursing education and practice activities
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p.001087: under part D.
p.001087: (g) STATE AND REGIONAL PRIORITIES.—Activities under grants or contracts under this title shall, to the
p.001087: extent practicable, be con- sistent with related Federal, State, or regional nursing professions program plans and
p.001087: priorities.
p.001087: (h) FILING OF APPLICATIONS.—
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p.001089: other advanced nurse education programs eligible for support under this section.
p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
p.001089: the costs of special projects to increase nursing education opportunities for individuals who are from
p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
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p.001089:
p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
p.001091: Islander Nurses, the Native American Indian and Alas- kan Nurses Association, and the National Council of State
p.001091: Boards of Nursing, and other organizations determined appropriate by the Secretary.
p.001091: (c) REQUIRED INFORMATION AND CONDITIONS FOR AWARD RE-
p.001091: CIPIENTS.—
p.001091: (1) IN GENERAL.—Recipients of awards under this section may be required, where requested, to report to
p.001091: the Secretary concerning the annual admission, retention, and graduation rates for individuals from
p.001091: disadvantaged backgrounds and eth- nic and racial minorities in the school or schools involved in the
p.001091: projects.
p.001091: (2) FALLING RATES.—If any of the rates reported under paragraph (1) fall below the average of the two previous
p.001091: years, the grant or contract recipient shall provide the Secretary with plans for immediately improving such rates.
p.001091: (3) INELIGIBILITY.—A recipient described in paragraph (2) shall be ineligible for continued funding under
p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
p.001091:
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p.001091: January 30, 2020
p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
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p.001113: models, and dissemi- nate effective strategies and models;
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001115: PUBLIC HEALTH SERVICE ACT
p.001115: Sec. 903
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p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
p.001115: (5) in carrying out section 902(c), provide support to in- crease the number of researchers who are
p.001115: members of health disparity populations, and the health services research capac- ity of institutions that
p.001115: train such researchers; and
p.001115: (6) beginning with fiscal year 2003, annually submit to the Congress a report regarding prevailing disparities in
p.001115: health care delivery as it relates to racial factors and socioeconomic factors in priority populations.
p.001115: (b) RESEARCH AND DEMONSTRATION PROJECTS.—
p.001115: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor shall conduct and support research and support
p.001115: demonstra- tions to—
p.001115: (A) identify the clinical, cultural, socioeconomic, geo- graphic, and organizational factors that
p.001115: contribute to health disparities, including minority health disparity pop- ulations, which research shall include
p.001115: behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach,
p.001115: and the availability of related support services (such as cultural and linguistic services);
p.001115: (B) identify and evaluate clinical and organizational strategies to improve the quality, outcomes, and
p.001115: access to care for health disparity populations, including minority health disparity populations;
p.001115: (C) test such strategies and widely disseminate those strategies for which there is scientific evidence of
p.001115: effective- ness; and
p.001115: (D) determine the most effective approaches for dis- seminating research findings to health disparity
p.001115: popu- lations, including minority populations.
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p.001115: disparity populations. In exam- ining such practices of providers funded under the authorities of this Act,
p.001115: the Director shall consult with the heads of the rel- evant agencies of the Public Health Service.
p.001115: (3) REPORT.—Not later than 36 months after the date of the enactment of this section, the Secretary, acting
p.001115: through the Director, shall prepare and submit to the appropriate commit- tees of Congress a report describing the
p.001115: state-of-the-art of qual- ity measurement for minority and other health disparity popu- lations that will identify
p.001115: critical unmet needs, the current ac- tivities of the Department to address those needs, and a de-
p.001115: scription of related activities in the private sector.
p.001115: (d) DEFINITION.—For purposes of this section:
p.001115: (1) The term ‘‘health disparity population’’ has the mean- ing given such term in section 464z–3, except that
p.001115: in addition to the meaning so given, the Director may determine that such term includes populations for which
p.001115: there is a significant dis- parity in the quality, outcomes, cost, or use of health care serv- ices or access to or
p.001115: satisfaction with such services as compared to the general population.
p.001115: (2) The term ‘‘minority’’, with respect to populations, refers to racial and ethnic minority groups as defined in
p.001115: section 1707.
p.001115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001117: PUBLIC HEALTH SERVICE ACT
p.001117: Sec. 912
p.001117:
p.001117: PART B—HEALTH CARE IMPROVEMENT RESEARCH
p.001117: SEC. 911. ø299b¿ HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
p.001117: (a) EVIDENCE RATING SYSTEMS.—In collaboration with experts from the public and private sector, the Agency
p.001117: shall identify and disseminate methods or systems to assess health care research re- sults, particularly methods
p.001117: or systems to rate the strength of the scientific evidence underlying health care practice, recommenda-
p.001117: tions in the research literature, and technology assessments. The Agency shall make methods or systems
p.001117: for evidence rating widely available. Agency publications containing health care recommenda- tions shall indicate
p.001117: the level of substantiating evidence using such methods or systems.
p.001117: (b) HEALTH CARE IMPROVEMENT RESEARCH CENTERS AND PRO-
p.001117: VIDER-BASED RESEARCH NETWORKS.—
p.001117: (1) IN GENERAL.—In order to address the full continuum of care and outcomes research, to link research to
p.001117: practice im- provement, and to speed the dissemination of research findings to community practice settings, the
p.001117: Agency shall employ re- search strategies and mechanisms that will link research di- rectly with clinical
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p.001273: January 30, 2020
p.001273: OFFICE OF MINORITY HEALTH
p.001273: SEC. 1707. ø300u–6¿ (a) IN GENERAL.—There is established an Office of Minority Health. The Office of Minority Health as
p.001273: existing on the date of enactment of the Patient Protection and Affordable Care Act shall be transferred to
p.001273: the Office of the Secretary in such manner that there is established in the Office of the Secretary, the Office of
p.001273: Minority Health, which shall be headed by the Deputy As- sistant Secretary for Minority Health who shall report
p.001273: directly to the Secretary, and shall retain and strengthen authorities (as in existence on such date of
p.001273: enactment) for the purpose of improving minority health and the quality of health care minorities
p.001273: receive, and eliminating racial and ethnic disparities. In carrying out this subsection, the Secretary, acting
p.001273: through the Deputy Assistant Sec- retary, shall award grants, contracts, enter into memoranda of un- derstanding,
p.001273: cooperative, interagency, intra-agency and other agreements with public and nonprofit private entities,
p.001273: agencies, as well as Departmental and Cabinet agencies and organizations, and
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001273: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1274
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p.001273: with organizations that are indigenous human resource providers in communities of color to assure improved
p.001273: health status of racial and ethnic minorities, and shall develop measures to evaluate the effectiveness
p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
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p.001275: 1275
p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
p.001275: (2) DUTIES.—The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section,
p.001275: including advice on the development of goals and specific program activi- ties under paragraphs (1) through (10)
p.001275: of subsection (b) for each racial and ethnic minority group.
p.001275: (3) CHAIR.—The chairperson of the Committee shall be se- lected by the Secretary from among the members of the voting
p.001275: members of the Committee. The term of office of the chair- person shall be 2 years.
p.001275: (4) COMPOSITION.—
p.001275: (A) The Committee shall be composed of 12 voting members appointed in accordance with subparagraph (B),
p.001275: and nonvoting, ex officio members designated in subpara- graph (C).
p.001275: (B) The voting members of the Committee shall be ap- pointed by the Secretary from among individuals who are
p.001275: not officers or employees of the Federal Government and who have expertise regarding issues of minority
p.001275: health. The racial and ethnic minority groups shall be equally rep- resented among such members.
p.001275: (C) The nonvoting, ex officio members of the Com- mittee shall be such officials of the Department of
p.001275: Health and Human Services as the Secretary determines to be ap- propriate.
p.001275: (5) TERMS.—Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall
p.001275: initially ap- point a portion of the members to terms of 1 year, 2 years, and 3 years.
p.001275: (6) VACANCIES.—If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary
p.001275: within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which the
p.001275: predecessor of such mem- ber was appointed. The vacancy shall not affect the power of the remaining members
p.001275: to execute the duties of the Com- mittee.
p.001275: (7) COMPENSATION.—Members of the Committee who are officers or employees of the United States shall serve
p.001275: without compensation. Members of the Committee who are not officers or employees of the United States shall
p.001275: receive compensation, for each day (including travel time) they are engaged in the performance of the
p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
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p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
p.001275: paragraph (1) during the pre- ceding 2 fiscal years. The report shall be included in the report required under
p.001275: subsection (f) for the fiscal year involved.
p.001275: (f) REPORTS.—
p.001275: (1) IN GENERAL.—Not later than February 1 of fiscal year 1999 and of each second year thereafter, the
p.001275: Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the
p.001275: Committee on Labor and Human Resources of the Senate, a report describing the activi- ties carried out under this
p.001275: section during the preceding 2 fiscal years and evaluating the extent to which such activities have been
p.001275: effective in improving the health of racial and ethnic mi- nority groups. Each such report shall include the
p.001275: biennial re- ports submitted under sections 201(e)(3) and 201(f)(2) for such years by the heads of the Public Health
p.001275: Service agencies.
p.001275: (2) AGENCY REPORTS.—Not later than February 1, 1999, and biennially thereafter, the heads of the Public Health
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p.001277: PUBLIC HEALTH SERVICE ACT
p.001277: Sec. 1707A
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p.001277: ice agencies shall submit to the Deputy Assistant Secretary a report summarizing the minority health
p.001277: activities of each of the respective agencies.
p.001277: (g) DEFINITION.—For purposes of this section:
p.001277: (1) The term ‘‘racial and ethnic minority group’’ means American Indians (including Alaska Natives,
p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
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p.001277: appro- priated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994
p.001277: through 1997.
p.001277: (d) INFORMATION CLEARINGHOUSE.—In carrying out subsection (b), the Secretary shall establish and maintain a
p.001277: National Informa- tion Clearinghouse on Adolescent Health to collect and disseminate to health professionals and
p.001277: the general public information on ado- lescent health.
p.001277: (e) NATIONAL PLAN.—In carrying out subsection (b), the Sec- retary shall develop a national plan
p.001277: for improving adolescent health. The plan shall be consistent with the applicable objectives established
p.001277: by the Secretary for the health status of the people of the United States for the year 2000, and
p.001277: shall be periodically re- viewed, and as appropriate, revised. The plan, and any revisions in the plan, shall be
p.001277: submitted to the Committee on Energy and Com- merce of the House of Representatives and the Committee on Labor and
p.001277: Human Resources of the Senate.
p.001277: (f) ADOLESCENT HEALTH.—For purposes of this section, the term ‘‘adolescent health’’, with respect to
p.001277: adolescents of all ethnic
p.001277: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001279: 1279
p.001279: PUBLIC HEALTH SERVICE ACT
p.001279: Sec. 1711
p.001279:
p.001279: and racial groups, means all diseases, disorders, and conditions (in- cluding with respect to mental health)—
p.001279: (1) unique to adolescents, or more serious or more preva- lent in adolescents;
p.001279: (2) for which the factors of medical risk or types of medical intervention are different for adolescents, or for which
p.001279: it is un- known whether such factors or types are different for adoles- cents; or
p.001279: (3) with respect to which there has been insufficient clin- ical research involving adolescents as
p.001279: subjects or insufficient clinical data on adolescents.
p.001279: BIENNIAL REPORT REGARDING NUTRITION AND HEALTH
p.001279: SEC. 1709. ø300u–8¿ (a) BIENNIAL REPORT.—The Secretary
p.001279: shall require the Surgeon General of the Public Health Service to prepare biennial reports on the
p.001279: relationship between nutrition and health. Such reports may, with respect to such relationship, include any
p.001279: recommendations of the Secretary and the Surgeon General.
p.001279: (b) SUBMISSION TO CONGRESS.—The Secretary shall ensure that, not later than February 1 of 1995 and
p.001279: of every second year thereafter, a report under subsection (a) is submitted to the Com- mittee on
p.001279: Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the
p.001279: Senate.
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p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
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p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001527:
p.001529: 1529
p.001529: PUBLIC HEALTH SERVICE ACT
p.001529: Sec. 2693
p.001529:
p.001529: 2011, $15,049,000 for fiscal year 2012, and $15,802,000 for fis- cal year 2013.
p.001529: Subpart III—Minority AIDS Initiative
p.001529:
p.001529:
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001529: Sec. 2693 PUBLIC HEALTH SERVICE ACT 1530
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p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001697: Sec. 3101 PUBLIC HEALTH SERVICE ACT 1698
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p.001697: January 30, 2020
p.001697:
p.001697: reau of Labor Statistics and the Bureau of the Census) collects and reports, to the extent practicable—
p.001697: (A) data on race, ethnicity, sex, primary language, and disability status for applicants, recipients, or
p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
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p.001699:
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p.001699: January 30, 2020
p.001699: 1 So in law. Subsection (b) includes a paragraph (1) but there are no subsequent paragraphs.
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: Sec. 3301 PUBLIC HEALTH SERVICE ACT 1700
p.001699:
p.001699: Accountability Act of 1996 (Public Law 104–191; 110
p.001699: Stat. 2033); and
p.001699: (ii) from all inappropriate internal use by any en- tity that collects, stores, or receives the data, including use of
p.001699: such data in determinations of eligibility (or continued eligibility) in health plans, and from other
p.001699: inappropriate uses, as defined by the Secretary; and
p.001699: (B) all appropriate information security safeguards are used in the collection, analysis, and sharing of data
p.001699: col- lected pursuant to subsection (a).
p.001699: (2) DATA SHARING.—The Secretary shall establish proce- dures for sharing data collected pursuant to
p.001699: subsection (a), measures relating to such data, and analyses of such data, with other relevant Federal
p.001699: and State agencies including the agencies, centers, and entities within the Department of Health and
p.001699: Human Services specified in subsection (c)(1)..
p.001699: (f) DATA ON RURAL UNDERSERVED POPULATIONS.—The Sec- retary shall ensure that any data collected in accordance
p.001699: with this section regarding racial and ethnic minority groups are also col- lected regarding underserved rural
p.001699: and frontier populations.
p.001699: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001699: to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.
p.001699: (h) REQUIREMENT FOR IMPLEMENTATION.—Notwithstanding any other provision of this section, data may not be collected
p.001699: under this section unless funds are directly appropriated for such purpose in an appropriations Act.
p.001699: (i) CONSULTATION.—The Secretary shall consult with the Direc- tor of the Office of Personnel Management, the
p.001699: Secretary of De- fense, the Secretary of Veterans Affairs, the Director of the Bureau of the Census, the
p.001699: Commissioner of Social Security, and the head of other appropriate Federal agencies in carrying out this
p.001699: section.
p.001699: TITLE XXXII—øREPEALED.¿
p.001699:
p.001699: øTitle XXXII of Public Health Service Act was repealed by sec- tion 642(a) of Public Law 112–240.¿
p.001699:
p.001699: TITLE XXXIII—WORLD TRADE CENTER HEALTH PROGRAM
p.001699: Subtitle A—Establishment of Program; Advisory Committee
p.001699:
p.001699:
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p.001699: January 30, 2020
p.001699: SEC. 3301. ø42 U.S.C. 300mm¿ ESTABLISHMENT OF WORLD TRADE CEN- TER HEALTH PROGRAM.
p.001699: (a) IN GENERAL.—There is hereby established within the De- partment of Health and Human Services a
p.001699: program to be known as the World Trade Center Health Program, which shall be admin-
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p.000231: PUBLIC HEALTH SERVICE ACT
p.000231: Sec. 319G
p.000231:
p.000231: elects to accept the compensation, the individual may not bring such an action.
p.000231: (e) DEFINITIONS.—For purposes of this section, the following terms shall have the following meanings:
p.000231: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ has the meaning given such term in section 319F–
p.000231: 3.
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p.000231:
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p.000231:
p.000231: January 30, 2020
p.000231: (2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’, with respect to administration or use of a
p.000231: covered counter- measure pursuant to a declaration, means an individual—
p.000231: (A) who is in a population specified in such declara- tion, and with respect to whom the administration
p.000231: or use of the covered countermeasure satisfies the other specifica- tions of such declaration; or
p.000231: (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith
p.000231: belief that the individual is in the category described by subparagraph (A).
p.000231: (3) COVERED INJURY.—The term ‘‘covered injury’’ means se- rious physical injury or death.
p.000231: (4) DECLARATION.—The term ‘‘declaration’’ means a dec- laration under section 319F–3(b).
p.000231: (5) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who is determined, in
p.000231: accordance with subsection (b), to be a covered individual who sustains a cov- ered injury.
p.000231: SEC. 319G. ø247d–7¿ DEMONSTRATION PROGRAM TO ENHANCE BIO- TERRORISM TRAINING, COORDINATION, AND READINESS.
p.000231: (a) IN GENERAL.—The Secretary shall make grants to not more than three eligible entities to carry out demonstration
p.000231: programs to improve the detection of pathogens likely to be used in a bioter- rorist attack, the development
p.000231: of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various
p.000231: responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population.
p.000231: Such awards shall be made on a competitive basis and pursuant to scientific and tech- nical review.
p.000231: (b) ELIGIBLE ENTITIES.—Eligible entities for grants under sub- section (a) are States, political subdivisions of
p.000231: States, and public or private non-profit organizations.
p.000231: (c) SPECIFIC CRITERIA.—In making grants under subsection (a), the Secretary shall take into account the following
p.000231: factors:
p.000231: (1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university
...

p.000397: biological product before the date that such patent expires; and
p.000397: (iii) shall provide to the reference product sponsor a response regarding each patent identified by the ref- erence
p.000397: product sponsor under subparagraph (A)(ii).
p.000397: (C) DESCRIPTION BY REFERENCE PRODUCT SPONSOR.— Not later than 60 days after receipt of the list and
p.000397: state- ment under subparagraph (B), the reference product spon- sor shall provide to the subsection (k) applicant a
p.000397: detailed statement that describes, with respect to each patent de- scribed in subparagraph (B)(ii)(I), on
p.000397: a claim by claim basis, the factual and legal basis of the opinion of the ref- erence product sponsor that such
p.000397: patent will be infringed by the commercial marketing of the biological product that is the subject of the
p.000397: subsection (k) application and a re- sponse to the statement concerning validity and enforce- ability
p.000397: provided under subparagraph (B)(ii)(I).
p.000397: (4) PATENT RESOLUTION NEGOTIATIONS.—
p.000397: (A) IN GENERAL.—After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the ref-
p.000397: erence product sponsor and the subsection (k) applicant
p.000397: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000397:
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p.000397: Sec. 351 PUBLIC HEALTH SERVICE ACT 398
p.000397:
p.000397: shall engage in good faith negotiations to agree on which, if any, patents listed under paragraph (3)
p.000397: by the sub- section (k) applicant or the reference product sponsor shall be the subject of an action for
p.000397: patent infringement under paragraph (6).
p.000397: (B) FAILURE TO REACH AGREEMENT.—If, within 15 days of beginning negotiations under subparagraph (A), the sub-
p.000397: section (k) applicant and the reference product sponsor fail to agree on a final and complete list of which, if any,
p.000397: pat- ents listed under paragraph (3) by the subsection (k) appli- cant or the reference product sponsor shall be
p.000397: the subject of an action for patent infringement under paragraph (6), the provisions of paragraph (5)
p.000397: shall apply to the parties.
p.000397: (5) PATENT RESOLUTION IF NO AGREEMENT.—
p.000397: (A) NUMBER OF PATENTS.—The subsection (k) appli- cant shall notify the reference product sponsor of the num- ber
p.000397: of patents that such applicant will provide to the ref- erence product sponsor under subparagraph (B)(i)(I).
p.000397: (B) EXCHANGE OF PATENT LISTS.—
p.000397: (i) IN GENERAL.—On a date agreed to by the sub- section (k) applicant and the reference product spon-
p.000397: sor, but in no case later than 5 days after the sub- section (k) applicant notifies the reference
p.000397: product sponsor under subparagraph (A), the subsection (k) applicant and the reference product sponsor
p.000397: shall si- multaneously exchange—
p.000397: (I) the list of patents that the subsection (k) applicant believes should be the subject of an ac- tion
p.000397: for patent infringement under paragraph (6); and
p.000397:
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p.000451: individuals that the Secretary determines are more likely to be otherwise unable to meet such ex- penses.
p.000451: (c) CERTAIN CIRCUMSTANCES.—The Secretary may, in carrying out subsection (a), consider—
p.000451:
p.000451:
p.000451:
p.000451:
p.000451:
p.000451: January 30, 2020
p.000451: 82 Clauses (i) and (ii) probably should be redesignated as subparagraphs (A) and (B). See sec- tion 204(b)(2) of Public
p.000451: Law 101–616 (104 Stat. 3285).
p.000451: 83 So in law. There probably should be a comma after ‘‘Senate’’ rather than a period. See sec- tion 205 of Public Law
p.000451: 101–616.
p.000451: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000451:
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p.000453: 453
p.000453: PUBLIC HEALTH SERVICE ACT
p.000453: Sec. 377A
p.000453:
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p.000453: January 30, 2020
p.000453: (1) the term ‘‘donating individuals’’ as including individ- uals who in good faith incur qualifying expenses
p.000453: toward the in- tended donation of an organ but with respect to whom, for such reasons as the Secretary determines
p.000453: to be appropriate, no do- nation of the organ occurs; and
p.000453: (2) the term ‘‘qualifying expenses’’ as including the ex- penses of having relatives or other
p.000453: individuals, not to exceed 2, accompany or assist the donating individual for purposes of subsection (a) (subject to
p.000453: making payment for only those types of expenses that are paid for a donating individual).
p.000453: (d) RELATIONSHIP TO PAYMENTS UNDER OTHER PROGRAMS.—An award may be made under subsection (a) only if the
p.000453: applicant in- volved agrees that the award will not be expended to pay the quali- fying expenses of a donating
p.000453: individual to the extent that payment has been made, or can reasonably be expected to be made, with re- spect to such
p.000453: expenses—
p.000453: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000453: health benefits program;
p.000453: (2) by an entity that provides health services on a prepaid basis; or
p.000453: (3) by the recipient of the organ.
p.000453: (e) DEFINITIONS.—For purposes of this section:
p.000453: (1) The term ‘‘donating individuals’’ has the meaning indi- cated for such term in subsection (a)(1), subject
p.000453: to subsection (c)(1).
p.000453: (2) The term ‘‘qualifying expenses’’ means the expenses au- thorized for purposes of subsection (a), subject to
p.000453: subsection (c)(2).
p.000453: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000453: to be appropriated
p.000453: $5,000,000 for each of the fiscal years 2005 through 2009.
...

p.000805: (2) an agreement that the entity will report to the Director any investigation of alleged research misconduct in
p.000805: connection with projects for which funds have been made available under this Act that appears substantial; and
p.000805: (3) an agreement that the entity will comply with regula- tions issued under this section.
p.000805: (c) PROCESS FOR RESPONSE OF DIRECTOR.—The Secretary shall by regulation establish a process to be followed by the
p.000805: Director for the prompt and appropriate—
p.000805: (1) response to information provided to the Director re- specting research misconduct in connection with
p.000805: projects for which funds have been made available under this Act;
p.000805: (2) receipt of reports by the Director of such information from recipients of funds under this Act;
p.000805: (3) conduct of investigations, when appropriate; and
p.000805: (4) taking of other actions, including appropriate remedies, with respect to such misconduct.
p.000805: (d) MONITORING BY DIRECTOR.—The Secretary shall by regula- tion establish procedures for the Director to monitor
p.000805: administrative processes and investigations that have been established or carried out under this section.
p.000805: (e) PROTECTION OF WHISTLEBLOWERS.—
p.000805: (1) IN GENERAL.—In the case of any entity required to es- tablish administrative processes under subsection
p.000805: (b), the Sec- retary shall by regulation establish standards for preventing, and for responding to the
p.000805: occurrence of retaliation by such en- tity, its officials or agents, against an employee in the terms and
p.000805: conditions of employment in response to the employee hav- ing in good faith—
p.000805: (A) made an allegation that the entity, its officials or agents, has engaged in or failed to adequately
p.000805: respond to an allegation of research misconduct; or
p.000805: (B) cooperated with an investigation of such an allega- tion.
p.000805: (2) MONITORING BY SECRETARY.—The Secretary shall by regulation establish procedures for the Director to monitor
p.000805: the implementation of the standards established by an entity under paragraph (1) for the purpose of
p.000805: determining whether the procedures have been established, and are being utilized,
p.000805: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000805:
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p.000807: 807
p.000807: PUBLIC HEALTH SERVICE ACT
p.000807: Sec. 493A
p.000807:
p.000807: in accordance with the standards established under such para- graph.
p.000807: (3) NONCOMPLIANCE.—The Secretary shall by regulation establish remedies for noncompliance by an entity, its
p.000807: officials or agents, which has engaged in retaliation in violation of the standards established under
p.000807: paragraph (1). Such remedies may include termination of funding provided by the Secretary for such project or
p.000807: recovery of funding being provided by the Sec- retary for such project, or other actions as appropriate.
p.000807:
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p.000977: $20,000 in the case of a student enrolled in a school of medicine, osteopathic medicine, dentistry, veterinary
p.000977: medicine, optometry, or podiatric medicine, and $12,500 in the case of a student enrolled in a school of pharmacy,
p.000977: public health, allied health, or chiropractic, or a graduate program in health adminis- tration or behavioral
p.000977: and mental health practice, including clinical psychology. The aggregate insured unpaid principal amount for all such
p.000977: insured loans made to any borrower shall not at any time ex- ceed $80,000 in the case of a borrower who is or was a
p.000977: student en- rolled in a school of medicine, osteopathic medicine, dentistry, vet- erinary medicine, optometry, or
p.000977: podiatric medicine, and $50,000 in the case of a borrower who is or was a student enrolled in a school of pharmacy,
p.000977: public health, allied health, or chiropractic, or a grad- uate program in health administration or clinical
p.000977: psychology. The annual insurable limit per student shall not be exceeded by a line of credit under which actual
p.000977: payments by the lender to the bor- rower will not be made in any year in excess of the annual limit.
p.000977: (b) EXTENT OF INSURANCE LIABILITY.—The insurance liability on any loan insured by the Secretary
p.000977: under this subpart shall be 100 percent of the unpaid balance of the principal amount of the loan plus
p.000977: interest. The full faith and credit of the United States is pledged to the payment of all amounts which may be
p.000977: required to be paid under the provisions of section 707 or 714.
p.000977: SEC. 704. ø292c¿ SOURCES OF FUNDS.
p.000977: Loans made by eligible lenders in accordance with this subpart shall be insurable by the Secretary whether made from
p.000977: funds fully owned by the lender or from funds held by the lender in a trust or similar capacity and
p.000977: available for such loans.
p.000977: SEC. 705. ø292d¿ ELIGIBILITY OF BORROWERS AND TERMS OF IN- SURED LOANS.
p.000977: (a) IN GENERAL.—A loan by an eligible lender shall be insur- able by the Secretary under the provisions of
p.000977: this subpart only if—
p.000977: (1) made to—
p.000977: (A) a student who—
p.000977: (i)(I) has been accepted for enrollment at an eligi- ble institution, or (II) in the case of a student attend-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000977:
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p.000979: 979
p.000979: PUBLIC HEALTH SERVICE ACT
p.000979: Sec. 705
p.000979:
p.000979: ing an eligible institution, is in good standing at that institution, as determined by the institution;
p.000979: (ii) is or will be a full-time student at the eligible institution;
p.000979: (iii) has agreed that all funds received under such loan shall be used solely for tuition, other reasonable
...

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p.001069: January 30, 2020
p.001069:
p.001069: tional average overdose death rate per 100,000 people, as re- ported by the Centers for Disease Control and
p.001069: Prevention.
p.001069: (e) INELIGIBILITY FOR DOUBLE BENEFITS.—No borrower may, for the same service, receive a reduction of
p.001069: loan obligations or a loan repayment under both—
p.001069: (1) this section; and
p.001069: (2) any Federally supported loan forgiveness program, in- cluding under section 338B, 338I, or 846 of this Act,
p.001069: or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965.
p.001069: (f) BREACH.—
p.001069: (1) LIQUIDATED DAMAGES FORMULA.—The Secretary may establish a liquidated damages formula to be used in the event
p.001069: of a breach of an agreement entered into under subsection (a).
p.001069: (2) LIMITATION.—The failure by an individual to complete the full period of service obligated pursuant to
p.001069: such an agree- ment, taken alone, shall not constitute a breach of the agree- ment, so long as the
p.001069: individual completed in good faith the years of service for which payments were made to the indi- vidual
p.001069: under this section.
p.001069: (g) ADDITIONAL CRITERIA.—The Secretary—
p.001069: (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed
p.001069: and in addition to the criteria and rules specified in this section; and
p.001069: (2) shall give notice to the committees specified in sub- section (h) of any criteria and rules so
p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
...

p.001129: (i) IN GENERAL.—A patient safety organization shall not be compelled to disclose information collected or
p.001129: developed under this part whether or not such in- formation is patient safety work product unless such
p.001129: information is identified, is not patient safety work
p.001129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001129:
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p.001129: Sec. 922 PUBLIC HEALTH SERVICE ACT 1130
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p.001129: January 30, 2020
p.001129:
p.001129: product, and is not reasonably available from another source.
p.001129: (ii) NONAPPLICATION.—The limitation contained in clause (i) shall not apply in an action against a patient safety
p.001129: organization or with respect to disclosures pur- suant to subsection (c)(1).
p.001129: (B) PROVIDERS.—An accrediting body shall not take an ac- crediting action against a provider based on the good faith
p.001129: par- ticipation of the provider in the collection, development, report- ing, or maintenance of patient safety
p.001129: work product in accord- ance with this part. An accrediting body may not require a pro- vider to reveal its
p.001129: communications with any patient safety or- ganization established in accordance with this part.
p.001129: (e) REPORTER PROTECTION.—
p.001129: (1) IN GENERAL.—A provider may not take an adverse em- ployment action, as described in paragraph (2), against an indi-
p.001129: vidual based upon the fact that the individual in good faith re- ported information—
p.001129: (A) to the provider with the intention of having the in- formation reported to a patient safety organization; or
p.001129: (B) directly to a patient safety organization.
p.001129: (2) ADVERSE EMPLOYMENT ACTION.—For purposes of this subsection, an ‘‘adverse employment action’’ includes—
p.001129: (A) loss of employment, the failure to promote an indi- vidual, or the failure to provide any other employment-re-
p.001129: lated benefit for which the individual would otherwise be eligible; or
p.001129: (B) an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of
p.001129: the individual.
p.001129: (f) ENFORCEMENT.—
p.001129: (1) CIVIL MONETARY PENALTY.—Subject to paragraphs (2) and (3), a person who discloses identifiable patient
p.001129: safety work product in knowing or reckless violation of subsection (b) shall be subject to a civil monetary penalty of
p.001129: not more than $10,000 for each act constituting such violation.
p.001129: (2) PROCEDURE.—The provisions of section 1128A of the Social Security Act, other than subsections (a) and (b)
p.001129: and the first sentence of subsection (c)(1), shall apply to civil money penalties under this subsection in
p.001129: the same manner as such provisions apply to a penalty or proceeding under section 1128A of the
p.001129: Social Security Act.
p.001129: (3) RELATION TO HIPAA.—Penalties shall not be imposed both under this subsection and under the
p.001129: regulations issued pursuant to section 264(c)(1) of the Health Insurance Port- ability and Accountability Act
p.001129: of 1996 (42 U.S.C. 1320d-2 note) for a single act or omission.
p.001129: (4) EQUITABLE RELIEF.—
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p.001217: promptness and in a manner which assures continuity, and when medically necessary be available and
p.001217: accessible twenty- four hours a day and seven days a week, except that a health maintenance organization which has
p.001217: a service area located wholly in a nonmetropolitan area may make a basic health service available outside
p.001217: its service area if that basic health service is not a primary care or emergency health care service and if
p.001217: there is an insufficient number of providers of that basic health service within the service area who will
p.001217: provide such service to members of the health maintenance organization. A member of a health maintenance
p.001217: organization shall be reim- bursed by the organization for his expenses in securing basic and supplemental
p.001217: health services other than through the orga- nization if the services were medically necessary and imme-
p.001217: diately required because of an unforeseen illness, injury, or condition.
p.001217: (5) To the extent that a natural disaster, war, riot, civil in- surrection, or any other similar event not within the
p.001217: control of a health maintenance organization (as determined under regu- lations of the Secretary) results in the
p.001217: facilities, personnel, or financial resources of a health maintenance organization not being available to
p.001217: provide or arrange for the provision of a basic or supplemental health service in accordance with the re-
p.001217: quirements of paragraphs (1) through (4) of this subsection, such requirements only require the
p.001217: organization to make a good-faith effort to provide or arrange for the provision of such service within such
p.001217: limitation on its facilities, personnel, or re- sources.
p.001217: (6) A health maintenance organization that otherwise meets the requirements of this title may offer a
p.001217: high-deductible health plan (as defined in section 220(c)(2) of the Internal Rev- enue Code of 1986).
p.001217: (c) Each health maintenance organization shall— (1)(A) have—
p.001217: (i) a fiscally sound operation, and
p.001217: (ii) adequate provision against the risk of insolvency, which is satisfactory to the Secretary, and (B) have
p.001217: administra- tive and managerial arrangements satisfactory to the Sec- retary;
p.001217: (2) assume full financial risk on a prospective basis for the provision of basic health services, except that a health
p.001217: mainte- nance organization may (A) obtain insurance or make other ar- rangements for the cost of providing to
p.001217: any member basic health services the aggregate value of which exceeds $5,000 in any year, (B) obtain insurance or
p.001217: make other arrangements for the cost of basic health services provided to its members other than through the
p.001217: organization because medical necessity re- quired their provision before they could be secured through the
p.001217: organization, (C) obtain insurance or make other arrangements for not more than 90 per centum of the amount
p.001217: by which its costs for any of its fiscal years exceed 115 per centum of its in- come for such fiscal year, and
p.001217: (D) make arrangements with physicians or other health professionals, health care institu- tions, or any
p.001217: combination of such individuals or institutions to
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p.001227: January 30, 2020
p.001227:
p.001227: (c)(1) The Secretary may from time to time, but with due re- gard to the financial interests of the United
p.001227: States, sell loans made by him under this title.
p.001227: (2) The Secretary may agree, prior to his sale of any such loan, to guarantee to the purchaser (and any successor in
p.001227: interest of the purchaser) compliance by the borrower with the terms and condi- tions of such loan. Any
p.001227: such agreement shall contain such terms and conditions as the Secretary considers necessary to protect
p.001227: the financial interests of the United States or as otherwise appropriate. Any such agreement may (A) provide that
p.001227: the Secretary shall act as agent of any such purchaser for the purpose of collecting from the borrower
p.001227: to which such loan was made and paying over to such purchaser, any payments of principal and interest payable by such
p.001227: organization under such loan; and (B) provide for the repurchase by the Secretary of any such loan on such
p.001227: terms and conditions as may be specified in the agreement. The full faith and credit of the United States is pledged to
p.001227: the payment of all amounts which may be required to be paid under any guarantee under this paragraph.
p.001227: (3) After any loan under this title to a public health mainte- nance organization has been sold and
p.001227: guaranteed under this sub- section, interest paid on such loan which is received by the pur- chaser
p.001227: thereof (or his successor in interest) shall be included in the gross income of the purchaser of the loan (or his
p.001227: successor in inter- est) for the purpose of chapter 1 of the Internal Revenue Code of 1954.
p.001227: (4) Amounts received by the Secretary as proceeds from the sale of loans under this subsection shall be
p.001227: deposited in the loan fund established under subsection (e).
p.001227: (5) Any reference in this title (other than in this subsection and in subsection (d)) to a loan guarantee
p.001227: under this title does not include a loan guarantee made under this subsection.
p.001227: (d)(1) There is established in the Treasury a loan guarantee fund (hereinafter in this subsection referred to
p.001227: as the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts as may be
p.001227: specified from time to time in appropria- tion Acts, to enable him to discharge his responsibilities under loan
p.001227: guarantees issued by him under this title and to take the action authorized by subsection (f). There
p.001227: are authorized to be appro- priated from time to time such amounts as may be necessary to provide the
p.001227: sums required for the fund. To the extent authorized in appropriation Acts, there shall also be
p.001227: deposited in the fund amounts received by the Secretary in connection with loan guaran- tees under this title
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p.001231:
p.001231: January 30, 2020
p.001231: that it provides basic and supplemental health services to its mem- bers in the manner prescribed by section 1301(b)
p.001231: and that it is or- ganized and operated in the manner prescribed by section 1301(c), and (2) an entity which
p.001231: proposes to become a health maintenance organization and which the Secretary determines will when it be-
p.001231: comes operational provide basic and supplemental health services to its members in the manner prescribed
p.001231: by section 1301(b) and will be organized and operated in the manner prescribed by section 1301(c).
p.001231: (d)(1) Any employer who knowingly does not comply with one or more of the requirements of paragraph (1)
p.001231: or (2) of subsection
p.001231: (b) shall be subject to a civil penalty of not more than $10,000. If such noncompliance continues, a civil
p.001231: penalty may be assessed and collected under this subsection for each thirty-day period such non- compliance continues.
p.001231: Such penalty may be assessed by the Sec- retary and collected in a civil action brought by the United
p.001231: States in a United States district court.
p.001231: (2) In any proceeding by the Secretary to assess a civil penalty under this subsection, no penalty shall be
p.001231: assessed until the em- ployer charged shall have been given notice and an opportunity to present its views on such
p.001231: charge. In determining the amount of the penalty, or the amount agreed upon in compromise, the Secretary shall
p.001231: consider the gravity of the noncompliance and the dem- onstrated good faith of the employer charged in
p.001231: attempting to achieve rapid compliance after notification by the Secretary of a noncompliance.
p.001231: (3) In any civil action brought to review the assessment of a civil penalty assessed under this subsection,
p.001231: the court shall, at the request of any party to such action, hold a trial de novo on the as- sessment of such civil
p.001231: penalty and in any civil action to collect such a civil penalty, the court shall, at the request of any party to such
p.001231: action, hold a trial de novo on the assessment of such civil penalty unless in a prior civil action to review the
p.001231: assessment of such pen- alty the court held a trial de novo on such assessment.
p.001231: (e) For purposes of this section, the term ‘‘employer’’ does not include (1) the Government of the
p.001231: United States, the government of the District of Columbia or any territory or possession of the United
p.001231: States, a State or any political subdivision thereof, or any agency or instrumentality (including the United
p.001231: States Postal Serv- ice and Postal Rate Commission) of any of the foregoing, except that such term includes
p.001231: nonappropriated fund instrumentalities of the Government of the United States; or (2) a church, convention or
p.001231: association of churches, or any organization operated, supervised or controlled by a church, convention or
p.001231: association of churches which organization (A) is an organization described in section 501(c)(3) of the
p.001231: Internal Revenue Code of 1986, and (B) does not discriminate (i) in the employment, compensation,
...

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p.001297:
p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
p.001299: (2) STANDARDIZED METHODS.—The Secretary shall estab- lish standardized methods for making the estimates
p.001299: required in subsection (b)(11) with respect to a State. A funding agree- ment for a grant under section
p.001299: 1911 for the State is that the State will utilize such methods in making the estimates.
p.001299: (3) DATE CERTAIN FOR COMPLIANCE BY SECRETARY.—Not later than 90 days after the date of the
p.001299: enactment of the ADAMHA Reorganization Act 1, the Secretary shall establish the definitions described in
p.001299: paragraph (1), shall begin dissemi- nation of the definitions to the States, and shall establish the
p.001299: standardized methods described in paragraph (2).
p.001299: (d) REQUIREMENT OF IMPLEMENTATION OF PLAN.—
p.001299: (1) COMPLETE IMPLEMENTATION.—Except as provided in paragraph (2), in making a grant under section 1911 to a State
p.001299: for a fiscal year, the Secretary shall make a determination of the extent to which the State has
p.001299: implemented the plan re- quired in subsection (a). If the Secretary determines that a State has not
p.001299: completely implemented the plan, the Secretary shall reduce the amount of the allotment under section
p.001299: 1911 for the State for the fiscal year involved by an amount equal to 10 percent of the amount determined
p.001299: under section 1918 for the State for the fiscal year.
p.001299: (2) SUBSTANTIAL IMPLEMENTATION AND GOOD FAITH EFFORT REGARDING FISCAL YEAR 1993.—
p.001299: (A) In making a grant under section 1911 to a State for fiscal year 1993, the Secretary shall make a
p.001299: determina- tion of the extent to which the State has implemented the plan required in subsection (a). If the Secretary
p.001299: determines that the State has not substantially implemented the plan, the Secretary shall, subject to subparagraph
p.001299: (B), reduce the amount of the allotment under section 1911 for the State for such fiscal year by an amount
p.001299: equal to 10 percent of the amount determined under section 1918 for the State for the fiscal year.
p.001299: (B) In carrying out subparagraph (A), if the Secretary determines that the State is making a good faith effort to
p.001299: implement the plan required in subsection (a), the Sec- retary may make a reduction under such subparagraph in
p.001299: an amount that is less than the amount specified in such subparagraph, except that the reduction may not be
p.001299: made in an amount that is less than 5 percent of the amount de- termined under section 1918 for the State for
p.001299: fiscal year 1993.
p.001299: SEC. 1913. ø300x–2¿ CERTAIN AGREEMENTS.
p.001299: (a) ALLOCATION FOR SYSTEMS OF INTEGRATED SERVICES FOR
p.001299: CHILDREN.—
p.001299: (1) IN GENERAL.—With respect to children with a serious emotional disturbance, a funding agreement for a grant
p.001299: under section 1911 is that—
p.001299: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 10 percent of
p.001299: the grant to increase (relative to fiscal year 1992) funding for
p.001299:
p.001299:
p.001299:
p.001299: January 30, 2020
p.001299: 1 Enacted July 10, 1992.
p.001299:
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001299:
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p.001299: Sec. 1913 PUBLIC HEALTH SERVICE ACT 1300
p.001299:
p.001299: the system of integrated services described in section 1912(b)(9);
p.001299: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 10 percent of the grant
...

p.001373:
p.001373: (3) reasonable attorneys’ fees and costs (as provided in subsection (e) 10.
p.001373: (c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and
p.001373: custodial care and service expenses under subsection (a)(1) shall be sufficient to en- able the compensated
p.001373: person to remain living at home.
p.001373: (d) TYPES OF COMPENSATION PROHIBITED.—Compensation awarded under the Program may not include the
p.001373: following:
p.001373: (1) Punitive or exemplary damages.
p.001373: (2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation
p.001373: for other than the health, education, or welfare of the person who suf- fered the vaccine-related injury with
p.001373: respect to which the com- pensation is paid.
p.001373: (e) ATTORNEYS’ FEES.—
p.001373: (1) In awarding compensation on a petition filed under sec- tion 2111 the special master or court shall also award as
p.001373: part of such compensation an amount to cover—
p.001373: (A) reasonable attorneys’ fees, and
p.001373: (B) other costs,
p.001373: incurred in any proceeding on such petition. If the judgment of a special master or court on such a petition
p.001373: does not award compensation, the special master or court may award an amount of compensation to
p.001373: cover petitioner’s reasonable attor- neys’ fees and other costs incurred in any proceeding on such
p.001373: petition if the special master or court determines that the peti- tion was brought in good faith and there was
p.001373: a reasonable basis for the claim for which the petition was brought.
p.001373: (2) If the petitioner, before the effective date of this part, 11 filed a civil action for damages for any
p.001373: vaccine-related injury or death for which compensation may be awarded under the Program, and petitioned under
p.001373: section 2111(a)(5) to have such action dismissed and to file a petition for compensation under the Program,
p.001373: in awarding compensation on such petition the special master or court may include an amount of compensa-
p.001373: tion limited to the costs and expenses incurred by the peti- tioner and the attorney of the petitioner
p.001373: before the effective date of this part 11 in preparing, filing, and prosecuting such civil action
p.001373: (including the reasonable value of the attorney’s time if the civil action was filed under contingent fee
p.001373: arrange- ments).
p.001373: (3) No attorney may charge any fee for services in connec- tion with a petition filed under section 2111 which
p.001373: is in addi- tion to any amount awarded as compensation by the special master or court under paragraph (1).
p.001373: (f) PAYMENT OF COMPENSATION.—
p.001373: (1) Except as provided in paragraph (2), no compensation may be paid until an election has been made,
p.001373: or has been deemed to have been made, under section 2121(a) to receive compensation.
p.001373:
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 10 So in law. Probably should be a closing parenthesis after ‘‘subsection (e)’’.
p.001373: 11 Effective October 1, 1988.
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
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p.001465: (d) DATE CERTAIN FOR SUBMISSION.—
p.001465: (1) REQUIREMENT.—Except as provided in paragraph (2), to be eligible to receive a grant under section 2601(a) for a
p.001465: fiscal year, an application under subsection (a) shall be submitted
p.001465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001465: Sec. 2605 PUBLIC HEALTH SERVICE ACT 1466
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p.001465: January 30, 2020
p.001465:
p.001465: not later than 45 days after the date on which appropriations are made under section 2677 for the fiscal
p.001465: year.
p.001465: (2) EXCEPTION.—The Secretary may extend the time for the submission of an application under paragraph (1) for a
p.001465: pe- riod of not to exceed 60 days if the Secretary determines that the eligible area has made a good
p.001465: faith effort to comply with the requirement of such paragraph but has otherwise been un- able to submit its
p.001465: application.
p.001465: (3) DISTRIBUTION BY SECRETARY.—Not later than 45 days after receiving an application that meets the
p.001465: requirements of subsection (a) from an eligible area, the Secretary shall dis- tribute to such eligible
p.001465: area the amounts awarded under the grant for which the application was submitted.
p.001465: (4) REDISTRIBUTION.—Any amounts appropriated in any fiscal year under this subpart and not obligated to
p.001465: an eligible entity as a result of the failure of such entity to submit an ap- plication shall be redistributed by the
p.001465: Secretary to other eligi- ble entities in proportion to the original grants made to such eligible areas under
p.001465: section 2601(a).
p.001465: (e) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001465: SERVICES.—
p.001465: (1) IN GENERAL.—The Secretary may not make a grant under section 2601 to an eligible area unless the
p.001465: eligible area provides assurances that in the provision of services with as- sistance provided under the
p.001465: grant—
p.001465: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the pro-
p.001465: vider will not impose charges on any such individual for the provision of services under the grant;
p.001465: (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the
p.001465: provider—
p.001465: (i) will impose a charge on each such individual for the provision of such services; and
...

p.001507: SEC. 2652. ø300ff–52¿ MINIMUM QUALIFICATIONS OF GRANTEES.
p.001507: (a) ELIGIBLE ENTITIES.—
p.001507: (1) IN GENERAL.—The entities referred to in section 2651(a) are public entities and nonprofit private entities that
p.001507: are—
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001507:
p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
...

p.001613: (C) Such other similar, limited benefits as are speci- fied in regulations.
p.001613: (3) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS INDEPENDENT, NONCOORDINATED BENEFITS.—
p.001613: (A) Coverage only for a specified disease or illness.
p.001613: (B) Hospital indemnity or other fixed indemnity insurance.
p.001613: (4) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS SEPARATE INSURANCE POLICY.—Medicare
p.001613: supplemental health insurance (as defined under section 1882(g)(1) of the So- cial Security Act), coverage
p.001613: supplemental to the coverage pro- vided under chapter 55 of title 10, United States Code, and similar
p.001613: supplemental coverage provided to coverage under a group health plan.
p.001613: (d) 29 OTHER DEFINITIONS.—
p.001613: (1) APPLICABLE STATE AUTHORITY.—The term ‘‘applicable State authority’’ means, with respect to a health
p.001613: insurance issuer in a State, the State insurance commissioner or official or officials designated by the State
p.001613: to enforce the requirements of this title for the State involved with respect to such issuer.
p.001613: (2) BENEFICIARY.—The term ‘‘beneficiary’’ has the meaning given such term under section 3(8) of the Employee Retirement
p.001613: Income Security Act of 1974.
p.001613: (3) BONA FIDE ASSOCIATION.—The term ‘‘bona fide associa- tion’’ means, with respect to health insurance coverage
p.001613: offered in a State, an association which—
p.001613: (A) has been actively in existence for at least 5 years;
p.001613: (B) has been formed and maintained in good faith for purposes other than obtaining insurance;
p.001613: (C) does not condition membership in the association on any health status-related factor relating to an
p.001613: indi- vidual (including an employee of an employer or a depend- ent of an employee);
p.001613:
p.001613:
p.001613:
p.001613:
p.001613:
p.001613: January 30, 2020
p.001613: 29 For version of law for section 2791(d)(20)–(21) (as amended by section 1563(b) (relating to conforming
p.001613: amendments--originally designated as section 1562 and redesignated as section 1563 by section 10107(b)(1)) of
p.001613: Public Law 111–148) see note set out in italic typeface that appears after paragraph (19).
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001613:
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p.001695: Trust Fund under section 1841 of such Act, in such proportion as the Secretary determines appropriate.
p.001695: (E) AUTHORIZATION OF APPROPRIATIONS.—There is au- thorized to be appropriated to the Office of the
p.001695: Inspector General to carry out this section $10,000,000, to remain available until expended.
p.001695: (3) RESOLUTION OF CLAIMS.—
p.001695: (A) IN GENERAL.—The Office of the Inspector General, if such Office determines that a consultation regarding the
p.001695: health privacy and security rules promulgated under sec- tion 264(c) of the Health Insurance Portability
p.001695: and Ac- countability Act of 1996 (42 U.S.C. 1320d–2 note) will re- solve an information blocking claim,
p.001695: may refer such in- stances of information blocking to the Office for Civil Rights of the
p.001695: Department of Health and Human Services for resolution.
p.001695: (B) LIMITATION ON LIABILITY.—If a health care pro- vider or health information technology developer makes in-
p.001695: formation available based on a good faith reliance on con- sultations with the Office for Civil Rights of the
p.001695: Depart- ment of Health and Human Services pursuant to a referral under subparagraph (A), with respect to such
p.001695: information, the health care provider or developer shall not be liable for such disclosure or disclosures made
p.001695: pursuant to subpara- graph (A).
p.001695: (c) IDENTIFYING BARRIERS TO EXCHANGE OF CERTIFIED HEALTH INFORMATION TECHNOLOGY.—
p.001695: (1) TRUSTED EXCHANGE DEFINED.—In this section, the term ‘‘trusted exchange’’ with respect to certified electronic
p.001695: health records means that the certified electronic health record tech- nology has the technical capability
p.001695: to enable secure health in- formation exchange between users and multiple certified elec- tronic health
p.001695: record technology systems.
p.001695: (2) GUIDANCE.—The National Coordinator, in consultation with the Office for Civil Rights of the Department
p.001695: of Health and Human Services, shall issue guidance on common legal, governance, and security barriers
p.001695: that prevent the trusted ex- change of electronic health information.
p.001695: (3) REFERRAL.—The National Coordinator and the Office for Civil Rights of the Department of Health and Human
p.001695: Serv- ices may refer to the Inspector General instances or patterns of refusal to exchange health information
p.001695: with an individual or entity using certified electronic health record technology that is technically capable of
p.001695: trusted exchange and under conditions when exchange is legally permissible.
p.001695: (d) ADDITIONAL PROVISIONS.—
p.001695: (1) INFORMATION SHARING PROVISIONS.—The National Co- ordinator may serve as a technical consultant to the
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p.000223: (B) facts supporting the allegation that such alleged willful misconduct proximately caused the injury
p.000223: claimed; and
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p.000223: (C) facts supporting the allegation that the person on whose behalf the complaint was filed suffered death or
p.000223: se- rious physical injury.
p.000223: (4) VERIFICATION, CERTIFICATION, AND MEDICAL RECORDS.—
p.000223: (A) IN GENERAL.—In an action under subsection (d), the plaintiff shall verify the complaint in the manner stat-
p.000223: ed in subparagraph (B) and shall file with the complaint the materials described in subparagraph (C). A
p.000223: complaint that does not substantially comply with subparagraphs (B) and (C) shall not be accepted for filing
p.000223: and shall not stop the running of the statute of limitations.
p.000223: (B) VERIFICATION REQUIREMENT.—
p.000223: (i) IN GENERAL.—The complaint shall include a verification, made by affidavit of the plaintiff under oath,
p.000223: stating that the pleading is true to the knowl- edge of the deponent, except as to matters specifically
p.000223: identified as being alleged on information and belief, and that as to those matters the plaintiff believes it to
p.000223: be true.
p.000223: (ii) IDENTIFICATION OF MATTERS ALLEGED UPON IN- FORMATION AND BELIEF.—Any matter that is not spe- cifically
p.000223: identified as being alleged upon the informa- tion and belief of the plaintiff, shall be regarded for all
p.000223: purposes, including a criminal prosecution, as having been made upon the knowledge of the plaintiff.
p.000223: (C) MATERIALS REQUIRED.—In an action under sub- section (d), the plaintiff shall file with the complaint—
p.000223: (i) an affidavit, by a physician who did not treat the person on whose behalf the complaint was filed,
p.000223: certifying, and explaining the basis for such physi- cian’s belief, that such person suffered the serious
p.000223: physical injury or death alleged in the complaint and that such injury or death was proximately caused
p.000223: by the administration or use of a covered counter- measure; and
p.000223: (ii) certified medical records documenting such in- jury or death and such proximate causal connection.
p.000223: (5) THREE-JUDGE COURT.—Any action under subsection (d) shall be assigned initially to a panel of three judges.
p.000223: Such panel shall have jurisdiction over such action for purposes of considering motions to dismiss,
p.000223: motions for summary judg- ment, and matters related thereto. If such panel has denied such motions, or if
p.000223: the time for filing such motions has expired, such panel shall refer the action to the chief judge for
p.000223: assign- ment for further proceedings, including any trial. Section 1253 of title 28, United States Code, and paragraph
p.000223: (3) of subsection
p.000223: (b) of section 2284 of title 28, United States Code, shall not apply to actions under subsection (d).
p.000223: (6) CIVIL DISCOVERY.—
p.000223: (A) TIMING.—In an action under subsection (d), no dis- covery shall be allowed—
p.000223: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000225: PUBLIC HEALTH SERVICE ACT
p.000225: Sec. 319F–3
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p.000231: 231
p.000231: PUBLIC HEALTH SERVICE ACT
p.000231: Sec. 319G
p.000231:
p.000231: elects to accept the compensation, the individual may not bring such an action.
p.000231: (e) DEFINITIONS.—For purposes of this section, the following terms shall have the following meanings:
p.000231: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ has the meaning given such term in section 319F–
p.000231: 3.
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p.000231: January 30, 2020
p.000231: (2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’, with respect to administration or use of a
p.000231: covered counter- measure pursuant to a declaration, means an individual—
p.000231: (A) who is in a population specified in such declara- tion, and with respect to whom the administration
p.000231: or use of the covered countermeasure satisfies the other specifica- tions of such declaration; or
p.000231: (B) who uses the covered countermeasure, or to whom the covered countermeasure is administered, in a good faith
p.000231: belief that the individual is in the category described by subparagraph (A).
p.000231: (3) COVERED INJURY.—The term ‘‘covered injury’’ means se- rious physical injury or death.
p.000231: (4) DECLARATION.—The term ‘‘declaration’’ means a dec- laration under section 319F–3(b).
p.000231: (5) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who is determined, in
p.000231: accordance with subsection (b), to be a covered individual who sustains a cov- ered injury.
p.000231: SEC. 319G. ø247d–7¿ DEMONSTRATION PROGRAM TO ENHANCE BIO- TERRORISM TRAINING, COORDINATION, AND READINESS.
p.000231: (a) IN GENERAL.—The Secretary shall make grants to not more than three eligible entities to carry out demonstration
p.000231: programs to improve the detection of pathogens likely to be used in a bioter- rorist attack, the development
p.000231: of plans and measures to respond to bioterrorist attacks, and the training of personnel involved with the various
p.000231: responsibilities and capabilities needed to respond to acts of bioterrorism upon the civilian population.
p.000231: Such awards shall be made on a competitive basis and pursuant to scientific and tech- nical review.
p.000231: (b) ELIGIBLE ENTITIES.—Eligible entities for grants under sub- section (a) are States, political subdivisions of
p.000231: States, and public or private non-profit organizations.
p.000231: (c) SPECIFIC CRITERIA.—In making grants under subsection (a), the Secretary shall take into account the following
p.000231: factors:
p.000231: (1) Whether the eligible entity involved is proximate to, and collaborates with, a major research university
p.000231: with exper- tise in scientific training, identification of biological agents, medicine, and life sciences.
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p.000949: (2) NOTICES.—Program participants, public agencies that refer individuals to designated programs, and the
p.000949: appropriate Federal, State, or local governments that administer des- ignated programs or are program
p.000949: participants shall ensure that notice is provided to program beneficiaries or prospective program
p.000949: beneficiaries of their rights under this section.
p.000949: (3) ADDITIONAL REQUIREMENTS.—A program participant making a referral pursuant to paragraph (1) shall—
p.000949: (A) prior to making such referral, consider any list that the State or local government makes available of
p.000949: enti- ties in the geographic area that provide program services; and
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p.000949: (B) ensure that the individual makes contact with the
p.000949: alternative provider to which the individual is referred.
p.000949: (4) NONDISCRIMINATION.—A religious organization that is a program participant shall not in providing program services
p.000949: or engaging in outreach activities under designated programs dis- criminate against a program beneficiary or
p.000949: prospective pro- gram beneficiary on the basis of religion or religious belief.
p.000949: (g) FISCAL ACCOUNTABILITY.—
p.000949: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization that is a program participant
p.000949: shall be subject to the same regulations as other recipients of awards of Federal financial assistance to
p.000949: account, in accordance with generally accepted auditing principles, for the use of the funds provided under such
p.000949: awards.
p.000949: (2) LIMITED AUDIT.—With respect to the award involved, a religious organization that is a program participant
p.000949: shall seg- regate Federal amounts provided under award into a separate account from non-Federal funds. Only the award
p.000949: funds shall be subject to audit by the government.
p.000949: (h) COMPLIANCE.—With respect to compliance with this section by an agency, a religious organization may obtain
p.000949: judicial review of agency action in accordance with chapter 7 of title 5, United States Code.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000949:
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p.000949: Sec. 583 PUBLIC HEALTH SERVICE ACT 950
p.000949:
p.000949: SEC. 583. ø290kk–2¿ LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
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p.001335: contract, or coop- erative agreement under any substance abuse program under this title or title V shall not
p.001335: discriminate, in carrying out such program, against an individual described in subsection (e)(3) on the basis of
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: PUBLIC HEALTH SERVICE ACT
p.001337: Sec. 1957
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p.001337: religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in
p.001337: a religious practice.
p.001337: (g) FISCAL ACCOUNTABILITY.—
p.001337: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization providing services under any
p.001337: substance abuse program under this title or title V shall be subject to the same regulations as other
p.001337: nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such
p.001337: funds provided under such program.
p.001337: (2) LIMITED AUDIT.—Such organization shall segregate gov- ernment funds provided under such substance abuse
p.001337: program into a separate account. Only the government funds shall be subject to audit by the government.
p.001337: (h) COMPLIANCE.—Any party that seeks to enforce such party’s rights under this section may assert a civil action for
p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
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p.000221: (i) neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act
p.000221: or omission; or
p.000221: (ii) such an enforcement action has been initiated and the action has been terminated or finally resolved without a
p.000221: covered remedy.
p.000221: Any action or proceeding under subsection (d) shall be stayed during the pendency of such an enforcement
p.000221: action.
p.000221: (B) DEFINITIONS.—For purposes of this paragraph, the following terms have the following meanings:
p.000221: (i) ENFORCEMENT ACTION.—The term ‘‘enforcement action’’ means a criminal prosecution, an action seek- ing an
p.000221: injunction, a seizure action, a civil monetary proceeding based on willful misconduct, a mandatory recall
p.000221: of a product because voluntary recall was re- fused, a proceeding to compel repair or replacement of a product,
p.000221: a termination of an exemption under sec- tion 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic
p.000221: Act, a debarment proceeding, an investigator disqualification proceeding where an investigator is an employee or
p.000221: agent of the manufacturer, a revocation, based on willful misconduct, of an authorization under section 564 of
p.000221: such Act, or a suspension or withdrawal, based on willful misconduct, of an approval or clear- ance under
p.000221: chapter V of such Act or of a licensure under section 351 of this Act.
p.000221: (ii) COVERED REMEDY.—The term ‘‘covered rem- edy’’ means an outcome—
p.000221: (I) that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product
p.000221: recall, a repair or replacement of a prod- uct, a termination of an exemption under section 505(i) or
p.000221: 520(g) of the Federal Food, Drug, and Cosmetic Act, a debarment, an investigator dis- qualification, a
p.000221: revocation of an authorization under section 564 of such Act, or a suspension or withdrawal of an
p.000221: approval or clearance under chapter 5 of such Act or of a licensure under sec- tion 351 of this Act;
p.000221: and
p.000221: (II) that results from a final determination by a court or from a final agency action.
p.000221: (iii) FINAL.—The terms ‘‘final’’ and ‘‘finally’’—
p.000221: (I) with respect to a court determination, or to a final resolution of an enforcement action that is a court
p.000221: determination, mean a judgment from which an appeal of right cannot be taken or a vol- untary or stipulated
p.000221: dismissal; and
p.000221: (II) with respect to an agency action, or to a final resolution of an enforcement action that is an
p.000221: agency action, mean an order that is not sub- ject to further review within the agency and that has not
p.000221: been reversed, vacated, enjoined, or other-
p.000221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000223: PUBLIC HEALTH SERVICE ACT
p.000223: Sec. 319F–3
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p.000387: presents an imminent or substantial hazard to the public health, the Secretary shall issue an order
p.000387: immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this
p.000387: paragraph shall be issued in accordance with section 554 of title 5, United States Code.
p.000387: (2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per
p.000387: day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year
p.000387: beginning 1 year after the effective date of this para- graph, be increased by the percent change in the
p.000387: Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base
p.000387: quarter of the preceding year, adjusted to the nearest 1⁄10 of 1 percent. For purposes of this paragraph, the
p.000387: term ‘‘base quarter’’, as used with respect to a year, means the calendar quarter ending on September 30 of such
p.000387: year and the price index for a base quarter is the arithmetical mean of such index for the 3 months
p.000387: comprising such quarter.
p.000387: (e) No person shall interfere with any officer, agent, or em- ployee of the Service in the performance of any
p.000387: duty imposed upon him by this section or by regulations made by authority thereof.
p.000387: (f) Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be
p.000387: punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such
p.000387: fine and imprisonment, in the discretion of the court.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000389: PUBLIC HEALTH SERVICE ACT
p.000389: Sec. 351
p.000389:
p.000389: (g) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding
p.000389: the provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 1940 edition, title 21, ch. 9). 58
p.000389: (h) 59 A partially processed biological product which—
p.000389: (1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
p.000389: (2) is not intended for sale in the United States; and
p.000389: (3) is intended for further manufacture into final dosage form outside the United States,
p.000389: shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and
p.000389: Cosmetic Act (21 U.S.C. 321 et. seq.) if the product is manufactured, processed, packaged, and held in
p.000389: conformity with current good manufacturing practice requirements or meets international manufacturing
p.000389: standards as certified by an international standards organization recognized by the Secretary and meets the
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p.000421: (4) FINALITY OF JUDGMENT.—The judgment of the court af- firming or setting aside, in whole or in part, any
p.000421: such action of the Secretary shall be final, subject to review by the Su- preme Court of the United
p.000421: States upon certiorari or certifi-
p.000421: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000421:
p.000421:
p.000421:
p.000421: January 30, 2020
p.000421:
p.000421: cation as provided in section 1254 of title 28, United States Code.
p.000421: (l) SANCTIONS.—Any person who intentionally violates any re- quirement of this section or any regulation
p.000421: promulgated thereunder shall be imprisoned for not more than one year or fined under title 18, United States Code or
p.000421: both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be
p.000421: imprisoned for not more than 3 years or fined in accord- ance with title 18, United States Code or both.
p.000421: (m) FEES.—
p.000421: (1) CERTIFICATE FEES.—The Secretary shall require pay- ment of fees for the issuance and renewal of certificates,
p.000421: except that the Secretary shall only require a nominal fee for the issuance and renewal of certificates of
p.000421: waiver.
p.000421: (2) ADDITIONAL FEES.—The Secretary shall require the payment of fees for inspections of laboratories
p.000421: which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate
p.000421: in proficiency testing pro- grams approved under subsection (f)(3)(C).
p.000421: (3) CRITERIA.—
p.000421: (A) FEES UNDER PARAGRAPH (1).—Fees imposed under paragraph (1) shall be sufficient to cover the general costs of
p.000421: administering this section, including evaluating and monitoring proficiency testing programs approved under
p.000421: subsection (f) and accrediting bodies and implementing and monitoring compliance with the requirements of
p.000421: this section.
p.000421: (B) FEES UNDER PARAGRAPH (2).—Fees imposed under paragraph (2) shall be sufficient to cover the cost of
p.000421: the Secretary in carrying out the inspections and proficiency testing described in paragraph (2).
p.000421: (C) FEES IMPOSED UNDER PARAGRAPHS (1) AND (2).— Fees imposed under paragraphs (1) and (2) shall
p.000421: vary by group or classification of laboratory, based on such consid- erations as the Secretary determines are
p.000421: relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.
...

p.001237: (c) Each health maintenance organization shall make the infor- mation reported pursuant to subsection (a) available to
p.001237: its enrollees upon reasonable request.
p.001237: (d) The Secretary shall, as he deems necessary, conduct an evaluation of transactions reported to the
p.001237: Secretary under sub- section (a)(3) for the purpose of determining their adverse impact, if any, on the
p.001237: fiscal soundness and reasonableness of charges to the health maintenance organization with respect to which they
p.001237: tran- spired. The Secretary shall evaluate the reported transactions of not less than five, or if there are
p.001237: more than twenty health mainte- nance organizations reporting such transactions, not less than one- fourth of the
p.001237: health maintenance organizations reporting any such transactions under subsection (a)(3).
p.001237: (f) 4 Nothing in this section shall be construed to confer upon the Secretary any authority to approve
p.001237: or disapprove the rates charged by any health maintenance organization.
p.001237: (g) Any health maintenance organization failing to file with the Secretary the annual financial statement required in
p.001237: subsection (a) shall be ineligible for any Federal assistance under this title until such time as such
p.001237: statement is received by the Secretary and shall not be a qualified health maintenance organization for purposes of
p.001237: section 1310.
p.001237: (h) Whoever knowingly and willfully makes or causes to be made any false statement or representation of
p.001237: a material fact in any statement filed pursuant to this section shall be guilty of a fel- ony and upon conviction
p.001237: thereof shall be fined not more than
p.001237: $25,000 or imprisoned for not more than five years, or both.
p.001237: TITLE XIV—SAFETY OF PUBLIC WATER SYSTEMS
p.001237:
p.001237: øFor Text of This Title See Volume 2 of the Environmental Law Compilation¿
p.001237:
p.001237:
p.001237:
p.001237: January 30, 2020
p.001237: 4 Subsection (e) was repealed by section 810 of Public Law 99–660.
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001237:
p.001237:
p.001237:
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p.001237:
p.001237: Sec. 1501 PUBLIC HEALTH SERVICE ACT 1238
p.001237: TITLE XV—PREVENTIVE HEALTH MEAS- URES WITH RESPECT TO BREAST AND CERVICAL CANCERS
p.001237:
p.001237: SEC. 1501. ø300k¿ ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.
p.001237: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.001237: grants to States on the basis of an established competitive review process for the purpose of carrying out programs—
p.001237: (1) to screen women for breast and cervical cancer as a preventive health measure;
p.001237: (2) to provide appropriate referrals for medical treatment of women screened pursuant to paragraph (1)
p.001237: and to ensure, to the extent practicable, the provision of appropriate follow-up services and support services such
p.001237: as case management;
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p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000531:
p.000531:
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p.000531:
p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
...

p.000881: attributes needed to serve youth at risk for suicide and their families; and
p.000881:
p.000881:
p.000881:
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p.000881:
p.000881:
p.000881: January 30, 2020
p.000881: (G) third-party payers, managed care organizations, and related commercial industries.
p.000881: (3) POLICY DEVELOPMENT.—In carrying out this section, the Secretary shall—
p.000881: (A) coordinate and collaborate on policy development at the Federal level with the relevant
p.000881: Department of
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000881:
p.000881:
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p.000881:
p.000881: Sec. 520E PUBLIC HEALTH SERVICE ACT 882
p.000881:
p.000881: Health and Human Services agencies and suicide working groups; and
p.000881: (B) consult on policy development at the Federal level with the private sector, including consumer, medical,
p.000881: sui- cide prevention advocacy groups, and other health and education professional-based organizations, with
p.000881: respect to State-sponsored statewide or tribal youth suicide early intervention and prevention strategies.
p.000881: (f) RULE OF CONSTRUCTION; RELIGIOUS AND MORAL ACCOMMO- DATION.—Nothing in this section shall be construed to
p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
p.000881: object based on the parents’ or legal guardians’ religious beliefs or moral objections.
p.000881: (g) EVALUATIONS AND REPORT.—
p.000881: (1) EVALUATIONS BY ELIGIBLE ENTITIES.—Not later than 18 months after receiving a grant or cooperative agreement
p.000881: under this section, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted
p.000881: by the entity con- cerning the effectiveness of the activities carried out under the grant or agreement.
p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
p.000881:
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p.000881:
p.000881:
p.000881: January 30, 2020
p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
...

p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
p.000939:
p.000939: January 30, 2020
p.000939: 19 There is another part G in this title, which also begins with a section 581. See page 677. That
p.000939: part G relates to services provided through religious organizations.
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000939:
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p.000939: Sec. 582 PUBLIC HEALTH SERVICE ACT 940
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p.000939: January 30, 2020
p.000939:
p.000939: (a) will be distributed equitably among the regions of the country and among urban and rural areas.
p.000939: (e) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000939: period during which payments under such an award will be made to the recipient may not exceed 5 years.
p.000939: (f) EVALUATION.—The Secretary shall conduct an evaluation of each project carried out under this section and
p.000939: shall disseminate the results of such evaluations to appropriate public and private entities.
...

p.000945: of physical restraint and seclusion, including the needs and behaviors of the population served, relationship
p.000945: building, alternatives to re- straint, de-escalation methods, avoiding power struggles, thresholds for
p.000945: restraints, the physiological impact of restraint and seclusion, monitoring physical signs of distress and obtain-
p.000945: ing medical assistance, legal issues, position asphyxia, escape and evasion techniques, time limits for the use
p.000945: of restraint and
p.000945: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000945:
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p.000947: 947
p.000947: PUBLIC HEALTH SERVICE ACT
p.000947: Sec. 581
p.000947:
p.000947: seclusion, the process for obtaining approval for continued re- straints and seclusion, procedures to
p.000947: address problematic re- straints, documentation, processing with children, and follow- up with staff, and
p.000947: investigation of injuries and complaints; and
p.000947: (3) that such facilities provide complete and accurate noti- fication of deaths, as required under section 595A(1).
p.000947: (c) ENFORCEMENT.—A State to which this part applies that fails to comply with any requirement of this part,
p.000947: including a fail- ure to provide appropriate training and certification, shall not be eligible for
p.000947: participation in any program supported in whole or in part by funds appropriated under this Act.
p.000947: PART G 22—SERVICES PROVIDED THROUGH RELIGIOUS ORGANIZATIONS 23
p.000947: SEC. 581. ø290kk¿ APPLICABILITY TO DESIGNATED PROGRAMS.
p.000947: (a) DESIGNATED PROGRAMS.—Subject to subsection (b), this part applies to discretionary and formula grant
p.000947: programs adminis- tered by the Substance Abuse and Mental Health Services Admin- istration that make awards of
p.000947: financial assistance to public or pri- vate entities for the purpose of carrying out activities to prevent or treat
p.000947: substance abuse (in this part referred to as a ‘‘designated pro- gram’’). Designated programs include the program under
p.000947: subpart II of part B of title XIX (relating to formula grants to the States).
p.000947: (b) LIMITATION.—This part does not apply to any award of fi- nancial assistance under a designated program
p.000947: for a purpose other than the purpose specified in subsection (a).
p.000947: (c) DEFINITIONS.—For purposes of this part (and subject to sub- section (b)):
p.000947: (1) The term ‘‘designated program’’ has the meaning given such term in subsection (a).
p.000947: (2) The term ‘‘financial assistance’’ means a grant, coopera- tive agreement, or contract.
p.000947: (3) The term ‘‘program beneficiary’’ means an individual who receives program services.
p.000947: (4) The term ‘‘program participant’’ means a public or pri- vate entity that has received financial assistance under a
p.000947: des- ignated program.
p.000947: (5) The term ‘‘program services’’ means treatment for sub- stance abuse, or preventive services regarding such abuse,
p.000947: pro- vided pursuant to an award of financial assistance under a designated program.
p.000947: (6) The term ‘‘religious organization’’ means a nonprofit re- ligious organization.
p.000947:
p.000947:
p.000947:
p.000947:
p.000947:
p.000947:
p.000947:
p.000947:
p.000947:
p.000947: January 30, 2020
p.000947: 22 There are two parts G in this title. The first was added by section 3101 of Public Law 106– 310 (114 Stat. 1168) and
p.000947: relates to projects for children and violence; that part also begins with section 581. See page 669. Sections
p.000947: 3207 and 3208 of such Public Law (114 Stat. 1195, 1197) added parts H and I, respectively.
p.000947: Subsequently, part G above was added by section 144 of the Community Renewal Tax Relief Act of 2000 (as enacted
p.000947: into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A– 619), which provides that title V
p.000947: of this Act ‘‘is amended by adding at the end the following part:’’, thereby placing that part G after the
p.000947: part I added by Public Law 106–310.
p.000947: 23 Section 1955 of this Act also relates to religious organizations as providers of substance abuse
p.000947: services. That section was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.000947: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000947:
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p.000947: Sec. 582 PUBLIC HEALTH SERVICE ACT 948
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p.000947:
p.000947: SEC. 582. ø290kk–1¿ RELIGIOUS ORGANIZATIONS AS PROGRAM PAR- TICIPANTS.
p.000947: (a) IN GENERAL.—Notwithstanding any other provision of law, a religious organization, on the same basis
p.000947: as any other nonprofit private provider—
p.000947: (1) may receive financial assistance under a designated program; and
p.000947: (2) may be a provider of services under a designated pro- gram.
p.000947: (b) RELIGIOUS ORGANIZATIONS.—The purpose of this section is to allow religious organizations to be
p.000947: program participants on the same basis as any other nonprofit private provider without impair- ing the religious
p.000947: character of such organizations, and without di- minishing the religious freedom of program beneficiaries.
p.000947: (c) NONDISCRIMINATION AGAINST RELIGIOUS ORGANIZATIONS.—
p.000947: (1) ELIGIBILITY AS PROGRAM PARTICIPANTS.—Religious orga- nizations are eligible to be program participants on
p.000947: the same basis as any other nonprofit private organization as long as the programs are implemented consistent
p.000947: with the Establishment Clause and Free Exercise Clause of the First Amendment to the United States
p.000947: Constitution. Nothing in this Act shall be construed to restrict the ability of the Federal Government, or a
p.000947: State or local government receiving funds under such pro- grams, to apply to religious organizations the
p.000947: same eligibility conditions in designated programs as are applied to any other nonprofit private
p.000947: organization.
p.000947: (2) NONDISCRIMINATION.—Neither the Federal Government nor a State or local government receiving funds under
p.000947: des- ignated programs shall discriminate against an organization that is or applies to be a program participant
p.000947: on the basis that the organization has a religious character.
p.000947: (d) RELIGIOUS CHARACTER AND FREEDOM.—
p.000947: (1) RELIGIOUS ORGANIZATIONS.—Except as provided in this section, any religious organization that is a program
p.000947: partici- pant shall retain its independence from Federal, State, and local government, including such
p.000947: organization’s control over the definition, development, practice, and expression of its reli- gious beliefs.
p.000947: (2) ADDITIONAL SAFEGUARDS.—Neither the Federal Govern- ment nor a State shall require a religious organization to—
p.000947: (A) alter its form of internal governance; or
p.000947: (B) remove religious art, icons, scripture, or other sym- bols,
p.000947: in order to be a program participant.
p.000947: (e) EMPLOYMENT PRACTICES.—Nothing in this section shall be construed to modify or affect the provisions of any
p.000947: other Federal or State law or regulation that relates to discrimination in employ- ment. A religious
p.000947: organization’s exemption provided under section 702 of the Civil Rights Act of 1964 regarding employment practices
p.000947: shall not be affected by its participation in, or receipt of funds from, a designated program.
p.000947: (f) RIGHTS OF PROGRAM BENEFICIARIES.—
p.000947: (1) IN GENERAL.—If an individual who is a program bene- ficiary or a prospective program beneficiary objects
p.000947: to the reli-
p.000947: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000949: 949
p.000949: PUBLIC HEALTH SERVICE ACT
p.000949: Sec. 582
p.000949:
p.000949: gious character of a program participant, within a reasonable period of time after the date of such
p.000949: objection such program participant shall refer such individual to, and the appropriate Federal, State, or
p.000949: local government that administers a des- ignated program or is a program participant shall provide to
p.000949: such individual (if otherwise eligible for such services), pro- gram services that—
p.000949: (A) are from an alternative provider that is accessible to, and has the capacity to provide such services to,
p.000949: such individual; and
p.000949: (B) have a value that is not less than the value of the services that the individual would have received from
p.000949: the program participant to which the individual had such ob- jection.
p.000949: Upon referring a program beneficiary to an alternative pro- vider, the program participant shall notify
p.000949: the appropriate Federal, State, or local government agency that administers the program of such referral.
p.000949: (2) NOTICES.—Program participants, public agencies that refer individuals to designated programs, and the
p.000949: appropriate Federal, State, or local governments that administer des- ignated programs or are program
p.000949: participants shall ensure that notice is provided to program beneficiaries or prospective program
p.000949: beneficiaries of their rights under this section.
p.000949: (3) ADDITIONAL REQUIREMENTS.—A program participant making a referral pursuant to paragraph (1) shall—
p.000949: (A) prior to making such referral, consider any list that the State or local government makes available of
p.000949: enti- ties in the geographic area that provide program services; and
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p.000949: (B) ensure that the individual makes contact with the
p.000949: alternative provider to which the individual is referred.
p.000949: (4) NONDISCRIMINATION.—A religious organization that is a program participant shall not in providing program services
p.000949: or engaging in outreach activities under designated programs dis- criminate against a program beneficiary or
p.000949: prospective pro- gram beneficiary on the basis of religion or religious belief.
p.000949: (g) FISCAL ACCOUNTABILITY.—
p.000949: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization that is a program participant
p.000949: shall be subject to the same regulations as other recipients of awards of Federal financial assistance to
p.000949: account, in accordance with generally accepted auditing principles, for the use of the funds provided under such
p.000949: awards.
p.000949: (2) LIMITED AUDIT.—With respect to the award involved, a religious organization that is a program participant
p.000949: shall seg- regate Federal amounts provided under award into a separate account from non-Federal funds. Only the award
p.000949: funds shall be subject to audit by the government.
p.000949: (h) COMPLIANCE.—With respect to compliance with this section by an agency, a religious organization may obtain
p.000949: judicial review of agency action in accordance with chapter 7 of title 5, United States Code.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000949: Sec. 583 PUBLIC HEALTH SERVICE ACT 950
p.000949:
p.000949: SEC. 583. ø290kk–2¿ LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
p.000949: No funds provided under a designated program shall be ex- pended for sectarian worship, instruction, or
p.000949: proselytization.
p.000949: SEC. 584. ø290kk–3¿ EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG TREATMENT PROGRAMS.
p.000949: (a) FINDINGS.—The Congress finds that—
p.000949: (1) establishing unduly rigid or uniform educational quali- fication for counselors and other personnel in drug
p.000949: treatment programs may undermine the effectiveness of such programs; and
p.000949: (2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug
p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
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p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
...

p.001335: Micronesia.
p.001335: (4) The term ‘‘interim services’’, in the case of an indi- vidual in need of treatment for substance abuse
p.001335: who has been denied admission to a program of such treatment on the basis of the lack of the capacity of the
p.001335: program to admit the indi- vidual, means services for reducing the adverse health effects of such abuse,
p.001335: for promoting the health of the individual, and for reducing the risk of transmission of disease, which services
p.001335: are provided until the individual is admitted to such a pro- gram.
p.001335: SEC. 1955. ø300x–65¿ SERVICES PROVIDED BY NONGOVERNMENTAL OR-
p.001335: GANIZATIONS. 19
p.001335: (a) PURPOSES.—The purposes of this section are—
p.001335: (1) to prohibit discrimination against nongovernmental or- ganizations and certain individuals on the basis of
p.001335: religion in the distribution of government funds to provide substance abuse services under this
p.001335: title and title V, and the receipt of services under such titles; and
p.001335: (2) to allow the organizations to accept the funds to pro- vide the services to the individuals without
p.001335: impairing the reli- gious character of the organizations or the religious freedom of the individuals.
p.001335: (b) RELIGIOUS ORGANIZATIONS INCLUDED AS NONGOVERN-
p.001335: MENTAL PROVIDERS.—
p.001335: (1) IN GENERAL.—A State may administer and provide sub- stance abuse services under any program under this
p.001335: title or title V through grants, contracts, or cooperative agreements to provide assistance to beneficiaries under
p.001335: such titles with non- governmental organizations.
p.001335: (2) REQUIREMENT.—A State that elects to utilize non- governmental organizations as provided for
p.001335: under paragraph
p.001335: (1) shall consider, on the same basis as other nongovernmental organizations, religious organizations to provide
p.001335: services under substance abuse programs under this title or title V, so long as the programs under such
p.001335: titles are implemented in a man- ner consistent with the Establishment Clause of the first
p.001335: amendment to the Constitution. Neither the Federal Govern- ment nor a State or local government receiving
p.001335: funds under such programs shall discriminate against an organization that provides services under, or applies to
p.001335: provide services under, such programs, on the basis that the organization has a reli- gious character.
p.001335:
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p.001335: January 30, 2020
p.001335: 19 Part G of title V of this Act (the second part G; see page 677) also relates to religious orga- nizations as
p.001335: providers of substance abuse services. That part was added by section 144 of the Community Renewal Tax
p.001335: Relief Act of 2000 (as enacted into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A–619). Section
p.001335: 1955 above was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001335: Sec. 1955 PUBLIC HEALTH SERVICE ACT 1336
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p.001335: (c) RELIGIOUS CHARACTER AND INDEPENDENCE.—
p.001335: (1) IN GENERAL.—A religious organization that provides services under any substance abuse program under this
p.001335: title or title V shall retain its independence from Federal, State, and local governments, including such
p.001335: organization’s control over the definition, development, practice, and expression of its reli- gious beliefs.
p.001335: (2) ADDITIONAL SAFEGUARDS.—Neither the Federal Govern- ment nor a State or local government shall require a religious
p.001335: organization—
p.001335: (A) to alter its form of internal governance; or
p.001335: (B) to remove religious art, icons, scripture, or other symbols,
p.001335: in order to be eligible to provide services under any substance abuse program under this title or title V.
p.001335: (d) EMPLOYMENT PRACTICES.—
p.001335: (1) SUBSTANCE ABUSE.—A religious organization that pro- vides services under any substance abuse program
p.001335: under this title or title V may require that its employees providing serv- ices under such program
p.001335: adhere to rules forbidding the use of drugs or alcohol.
p.001335: (2) TITLE VII EXEMPTION.—The exemption of a religious or- ganization provided under section 702 or 703(e)(2) of the
p.001335: Civil Rights Act of 1964 (42 U.S.C. 2000e–1, 2000e–2(e)(2)) regard- ing employment practices shall not be
p.001335: affected by the religious organization’s provision of services under, or receipt of funds from, any substance
p.001335: abuse program under this title or title V.
p.001335: (e) RIGHTS OF BENEFICIARIES OF ASSISTANCE.—
p.001335: (1) IN GENERAL.—If an individual described in paragraph
p.001335: (3) has an objection to the religious character of the organiza- tion from which the individual receives, or
p.001335: would receive, serv- ices funded under any substance abuse program under this title or title V, the appropriate
p.001335: Federal, State, or local govern- mental entity shall provide to such individual (if otherwise eli- gible for such
p.001335: services) within a reasonable period of time after the date of such objection, services that—
p.001335: (A) are from an alternative provider that is accessible to the individual; and
p.001335: (B) have a value that is not less than the value of the services that the individual would have received from such
p.001335: organization.
p.001335: (2) NOTICE.—The appropriate Federal, State, or local gov- ernmental entity shall ensure that notice is
p.001335: provided to indi- viduals described in paragraph (3) of the rights of such individ- uals under this section.
p.001335: (3) INDIVIDUAL DESCRIBED.—An individual described in this paragraph is an individual who receives or
p.001335: applies for services under any substance abuse program under this title or title V.
p.001335: (f) NONDISCRIMINATION AGAINST BENEFICIARIES.—A religious organization providing services through a grant,
p.001335: contract, or coop- erative agreement under any substance abuse program under this title or title V shall not
p.001335: discriminate, in carrying out such program, against an individual described in subsection (e)(3) on the basis of
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: 1337
p.001337: PUBLIC HEALTH SERVICE ACT
p.001337: Sec. 1957
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p.001337: January 30, 2020
p.001337: religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in
p.001337: a religious practice.
p.001337: (g) FISCAL ACCOUNTABILITY.—
p.001337: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization providing services under any
p.001337: substance abuse program under this title or title V shall be subject to the same regulations as other
p.001337: nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such
p.001337: funds provided under such program.
p.001337: (2) LIMITED AUDIT.—Such organization shall segregate gov- ernment funds provided under such substance abuse
p.001337: program into a separate account. Only the government funds shall be subject to audit by the government.
p.001337: (h) COMPLIANCE.—Any party that seeks to enforce such party’s rights under this section may assert a civil action for
p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
p.001337: religious organiza- tion to provide services under any substance abuse program under this title or title V shall be
p.001337: expended for sectarian worship, instruc- tion, or proselytization.
p.001337: (j) EFFECT ON STATE AND LOCAL FUNDS.—If a State or local government contributes State or local funds to
p.001337: carry out any sub- stance abuse program under this title or title V, the State or local government may segregate
p.001337: the State or local funds from the Fed- eral funds provided to carry out the program or may commingle the State
p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
...

p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: and are frequently associated with or are a cause of other trou- blesome situations in the family; and
p.001341: (B) such problems are best approached through a variety of integrated and essential services provided to
p.001341: adolescents and their families by other family members, religious and chari- table organizations, voluntary
p.001341: associations, and other groups in the private sector as well as services provided by publicly spon- sored initiatives;
p.001341: (9) a wide array of educational, health, and supportive services are not available to adolescents with such
p.001341: problems or to their families, or when available frequently are fragmented and thus are of limited
p.001341: effectiveness in discouraging adolescent premarital sexual relations and the consequences of such rela- tions;
p.001341: (10)(A) prevention of adolescent sexual activity and adoles- cent pregnancy depends primarily upon developing strong
p.001341: fam- ily values and close family ties, and since the family is the basic social unit in which the
p.001341: values and attitudes of adoles- cents concerning sexuality and pregnancy are formed, pro- grams designed to
p.001341: deal with issues of sexuality and pregnancy will be successful to the extent that such programs encourage and
p.001341: sustain the role of the family in dealing with adolescent sexual activity and adolescent pregnancy;
p.001341: (B) Federal policy therefore should encourage the develop- ment of appropriate health, educational, and social
p.001341: services where such services are now lacking or inadequate, and the better coordination of existing
p.001341: services where they are avail- able; and
p.001341: (C) services encouraged by the Federal Government should promote the involvement of parents with their adolescent chil-
p.001341: dren, and should emphasize the provision of support by other family members, religious and charitable
p.001341: organizations, vol- untary associations, and other groups in the private sector in order to help adolescents
p.001341: and their families deal with complex issues of adolescent premarital sexual relations and the con- sequences of
p.001341: such relations; and
p.001341: (11)(A) there has been limited research concerning the so- cietal causes and consequences of adolescent pregnancy;
p.001341: (B) there is limited knowledge concerning which means of intervention are effective in mediating or
p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
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p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
p.001345: prevention services in easily accessible locations. Dem- onstration projects shall, as appropriate,
p.001345: provide, supplement, or improve the quality of such services. Demonstration projects shall use such methods
p.001345: as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of
p.001345: adolescents and to make use of support systems such as other family members, friends, religious and charitable
p.001345: organizations, and voluntary asso- ciations.
p.001345: (b) Grants under this title for demonstration projects may be for the provision of—
p.001345: (1) care services;
p.001345: (2) prevention services; or
p.001345: (3) a combination of care services and prevention services.
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p.001345: USES OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2004. ø300z–3¿ (a) Except as provided in subsection (b), funds provided for demonstration projects
p.001345: for services under this title may be used by grantees only to—
p.001345: (1) provide to eligible persons—
p.001345: (A) care services;
p.001345: (B) prevention services; or
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001345:
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p.001345: Sec. 2005 PUBLIC HEALTH SERVICE ACT 1346
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p.001349: application of any discount; and
p.001349: (C) assurances that the applicant has submitted or will submit to the Secretary such reports as the Secretary
p.001349: may re- quire to determine compliance with this paragraph;
p.001349: (17) assurances that the applicant will make maximum use of funds available under title X of this Act;
p.001349: (18) assurances that the acceptance by any individual of family planning services or family planning
p.001349: information (in- cluding educational materials) provided through financial as- sistance under this title
p.001349: shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service fur-
p.001349: nished by the applicant;
p.001349: (19) assurances that fees collected by the applicant for services rendered in accordance with this title shall
p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001349:
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p.001351: 1351
p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
p.001351: (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents
p.001351: or guardians of any unemancipated minor requesting services from the applicant and, except as provided in
p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001351: January 30, 2020
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p.000001: (b) The President may prescribe the conditions under which commissioned officers of the Service may be
p.000001: awarded military rib- bons, medals, and decorations.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: C:\XML\SSA-MERGED.XML
p.000001:
p.000001: Sec. 213 PUBLIC HEALTH SERVICE ACT 20
p.000001:
p.000001: (c) The authority vested by law in the Department of the Army, the Secretary of the Army, or other
p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
...

p.000017: any part of the cost of projects for training, studies, or demonstrations looking toward the development
p.000017: of im- proved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out
p.000017: this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June
p.000017: 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30,
p.000017: 1969,
p.000017: $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000
p.000017: for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and
p.000017: $4,700,000 for the fiscal year ending June 30, 1974.
p.000017: SEC. 315. ø42 U.S.C. 247¿ ASSISTING VETERANS WITH MILITARY EMER- GENCY MEDICAL TRAINING TO MEET REQUIREMENTS
p.000017: FOR BECOMING CIVILIAN HEALTH CARE PROFES- SIONALS.
p.000017: (a) PROGRAM.—
p.000017: (1) IN GENERAL.—The Secretary may establish a program, in consultation with the Secretary of Labor,
p.000017: consisting of awarding demonstration grants to States to streamline State requirements and procedures in
p.000017: order to assist veterans who held certain military occupational specialties related to medical care or who have
p.000017: completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification,
p.000017: licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni-
p.000017: cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician
p.000017: assistant professions) in the State.
p.000017: (2) CONSULTATION AND COLLABORATION.—In determining the eligible military occupational specialties or training
p.000017: courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of
p.000017: Defense, the Sec- retary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’
p.000017: Employment and Training, and shall col- laborate with the initiatives carried out under section 4114 of
p.000017: title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code.
p.000017: (b) USE OF FUNDS.—Amounts received as a demonstration grant under this section shall be used to—
p.000017: (1) prepare and implement a plan to streamline State re- quirements and procedures as described in
p.000017: subsection (a), in- cluding by—
p.000017: (A) determining the extent to which the requirements for the education, training, and skill level of civilian
p.000017: health care professions (such as emergency medical technicians, paramedics, licensed practical nurses,
p.000017: registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to
...

p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
p.000441: SEC. 363. 73 ø266¿ To protect the military and naval forces and war workers of the United States, in time of war,
p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
p.000441: prehension and examination, in time of war, of any individual rea- sonably believed (1) to be infected with such
p.000441: disease and (2) to be a probable source of infection to members of the armed forces of the
p.000441:
p.000441:
p.000441:
p.000441:
p.000441: January 30, 2020
p.000441: 73 Under section 3 of Public Law 239, 80th Congress, the date of July 25, 1947, is deemed, for purposes
p.000441: of this section, to be the date of termination of ‘‘any state of war heretofore declared by the Congress’’.
p.000441: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000441:
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p.000441:
p.000441: Sec. 364 PUBLIC HEALTH SERVICE ACT 442
p.000441:
p.000441: United States or to individuals engaged in the production or trans- portation of arms, munitions, ships, food,
p.000441: clothing, or other supplies for the armed forces. Such regulations may provide that if upon ex- amination any such
p.000441: individual is found to be so infected, he may be detained for such time and in such manner as may be
p.000441: reason- ably necessary.
p.000441: QUARANTINE STATIONS
p.000441: SEC. 364. ø267¿ (a) Except as provided in title II of the Act of June 15, 1917, as amended (U.S.C., 1940
p.000441: edition, title 50, secs. 191–194), 74 the Surgeon General shall control, direct, and manage all United States
p.000441: quarantine stations, grounds, and anchorages, designate their boundaries, and designate the quarantine
p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
...

p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: Sec. 501 PUBLIC HEALTH SERVICE ACT 828
p.000827: (21) collaborate with the heads of relevant Federal agen- cies and departments, States, communities, and
p.000827: nongovern- mental experts to improve mental and substance use disorders services for chronically homeless
p.000827: individuals, including by de- signing strategies to provide such services in supportive hous- ing;
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p.000827: January 30, 2020
p.000827: (22) work with States and other stakeholders to develop and support activities to recruit and retain a
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p.000979: (I) is directly related to the health profession for which the borrower prepared at an eligible in- stitution,
p.000979: as determined by the Secretary; and
p.000979: (II) may be engaged in by the borrower during such a two-year period which begins within twelve months after the
p.000979: completion of the borrower’s par- ticipation in a program described in subclause (I) or (II) of clause (i) or
p.000979: prior to the completion of the borrower’s participation in such program,
p.000979: except as provided in subparagraph (C), except that the period of the loan may not exceed 33 years
p.000979: from the date of execution of the note or written agreement evidencing it, and except that the note or other written
p.000979: instrument may contain such provisions relating to repayment in the event of default in the payment of interest or in
p.000979: the payment of the costs of insurance premiums, or other default by the borrower, as may be authorized by
p.000979: regulations of the Sec- retary in effect at the time the loan is made;
p.000979: (C) provides that periodic installments of principal and interest need not be paid, but interest shall accrue, during
p.000979: any period (i) during which the borrower is pursuing a full-time course of study at an eligible institution
p.000979: (or at an institution defined by section 102(a) of the Higher Edu- cation Act of 1965); (ii) not in
p.000979: excess of four years during which the borrower is a participant in an accredited in- ternship or
p.000979: residency program (including any period in such a program described in subclause (I) or subclause (II) of
p.000979: subparagraph (B)(i)); (iii) not in excess of three years, during which the borrower is a member of the
p.000979: Armed Forces of the United States; (iv) not in excess of three years during which the borrower is in
p.000979: service as a volun- teer under the Peace Corps Act; (v) not in excess of three years during which the
p.000979: borrower is a member of the Na- tional Health Service Corps; (vi) not in excess of three years during
p.000979: which the borrower is in service as a full-time volunteer under title I of the Domestic Volunteer Service Act
p.000979: of 1973; (vii) not in excess of 3 years, for a borrower who has completed an accredited internship or
p.000979: residency training program in osteopathic general practice, family medicine, general internal medicine,
p.000979: preventive medicine, or general pediatrics and who is practicing primary care;
p.000979: (viii) not in excess of 1 year, for borrowers who are grad- uates of schools of chiropractic; (ix) any
p.000979: period not in ex- cess of two years which is described in subparagraph (B)(ii); (x) not in
p.000979: excess of three years, during which the borrower is providing health care services to Indians
p.000979: through an Indian health program (as defined in section
p.000979: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000979:
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p.000981: 981
p.000981: PUBLIC HEALTH SERVICE ACT
p.000981: Sec. 705
p.000981:
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p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
p.001361:
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p.001361: January 30, 2020
p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
p.001361: (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a
p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
p.001361: (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table—
p.001361: (I) received the vaccine in the United States or in its trust territories,
p.001361: (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person
p.001361: was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the
p.001361: United States or a dependent of such a citizen, or
p.001361: (III) received the vaccine outside the United States or a trust territory and the vaccine was manu-
p.001361: factured by a vaccine manufacturer located in the United States and such person returned to the United States
p.001361: not later than 6 months after the date of the vaccination,
p.001361: (ii) if such person did not receive such a vaccine but contracted polio from another person who received an
p.001361: oral polio vaccine, was a citizen of the United States or a de- pendent of such a citizen,
p.001361: (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the
p.001361: Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the
p.001361: administration of such vaccine, and the first symptom or manifestation of the onset or of the significant
p.001361: aggravation of any such ill- ness, disability, injury, or condition or the death occurred within the
p.001361: time period after vaccine administration set forth in the Vaccine Injury Table, or
p.001361: (ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or condition not set
p.001361: forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
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p.000001: Sec. 201 PUBLIC HEALTH SERVICE ACT 2
p.000001:
p.000001: tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code);
p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
p.000001:
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p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
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p.000001: General under para- graph (1) shall not on any day exceed 1 per centum of the highest number, during the ninety
p.000001: days preceding such day, of officers of the Regular Corps on active duty and officers of the Reserve Corps on
p.000001: active duty for more than thirty days. If on any day the number of such special temporary positions exceeds such 1 per
p.000001: centum limi- tations, for a period of not more than one year after such day, the number of such special temporary
p.000001: positions shall be reduced for purposes of complying with such 1 per centum limitation only by the
p.000001: resignation, retirement, death, or transfer to a position of a lower grade, of any officer holding any such
p.000001: temporary position.
p.000001: (d) The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in
p.000001: case of absence or disability, or vacancy in the offices, of both the Surgeon General and the Deputy
p.000001: Surgeon General.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 7 PUBLIC HEALTH SERVICE ACT Sec. 206
p.000001:
p.000001: GRADES, RANKS, AND TITLES OF THE COMMISSIONED CORPS
p.000001: SEC. 206. ø207¿ (a) The Surgeon General during the period of his appointment as such, shall be of the same grade as the
p.000001: Surgeon General of the army; the Deputy Surgeon General and the Chief Medical Officer of the United
p.000001: States Coast Guard, while assigned as such, shall have the grade corresponding with the grade of major
p.000001: general; and the Chief Dental Officer, while assigned as such, shall have the grade as is prescribed by
p.000001: law for the officer of the Dental Corps selected and appointed as Assistant Surgeon General of the Army.
p.000001: During the period of appointment to the posi- tion of Assistant Secretary for Health, a commissioned officer of the
p.000001: Public Health Service shall have the grade corresponding to the grade of General of the Army. Assistant
p.000001: Surgeons General, while assigned as such, shall have the grade corresponding with either the grade of
p.000001: brigadier general or the grade of major general, as may be determined by the Secretary after considering
p.000001: the impor- tance of the duties to be performed: Provided, That the number of Assistant Surgeons General having a
p.000001: grade higher than that cor- responding to the grade of brigadier general shall at no time exceed one-half of the
p.000001: number of positions created by subsection (b) of sec- tion 205 or pursuant to subsection (c) of such section.
p.000001: The grades of commissioned officers of the Service shall correspond with grades of officers of the Army as follows:
p.000001: (1) Officers of the director grade—colonel;
p.000001: (2) Officers of the senior grade—lieutenant colonel;
p.000001: (3) Officers of the full grade—major;
p.000001: (4) Officers of the senior assistant grade—captain;
p.000001: (5) Officers of the assistant grade—first lieutenant;
p.000001: (6) Officers of the junior assistant grade—second lieuten-
p.000001: ant;
p.000001: (7) Chief warrant officers of (W–4) grade—chief warrant of-
p.000001: ficer (W–4);
p.000001: (8) Chief warrant officers of (W–3) grade—chief warrant of- ficer (W–3);
p.000001: (9) Chief warrant officers of (W–2) grade—chief warrant of- ficer (W–2); and
p.000001: (10) Warrant officers of (W–1) grade—warrant officer (W–
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 1).
p.000001: (b) The titles of medical officers of the foregoing grades shall be respectively (1) medical director, (2)
p.000001: senior surgeon, (3) surgeon,
p.000001: (4) senior assistant surgeon, (5) assistant surgeon and (6) junior as- sistant surgeon.
p.000001: (c) The President is authorized to prescribe titles, appropriate to the several grades, for commissioned
p.000001: officers of the Service other than medical officers. All titles of the officers of the Reserve Corps shall have the
p.000001: suffix ‘‘Reserve’’.
p.000001: (d) Within the total number of officers of the Regular Corps au- thorized by the appropriation Act or Acts for each
p.000001: fiscal year to be on active duty, the Secretary shall by regulation prescribe the max- imum number of officers
...

p.000001: prohibition in any other Act against the employment of aliens, or against the payment of compensation to them,
p.000001: shall not be applicable in the case of persons employed or appointed pursu- ant to such subsections.
p.000001: (i) The appointment of any officer or employee of the Service made in accordance with the civil-service laws
p.000001: shall be made by the Secretary, and may be made effective as of the date on which such officer or employee enters upon
p.000001: duty.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
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p.000001:
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p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001:
p.000001: PAY AND ALLOWANCES
p.000001: SEC. 208. ø210¿ (a)(1) Commissioned officers of the Regular and Reserve Corps shall be entitled to receive such
p.000001: pay and allow- ances as are now or may hereafter be authorized by law.
p.000001: (2) For provisions relating to the receipt of special pay by com- missioned officers of the Regular and Reserve Corps
p.000001: while on active duty, see section 303a(b) or 373 of title 37, United States Code.
p.000001: (b) Commissioned officers on active duty, and retired officers entitled to retired pay pursuant to section
p.000001: 210(g)(3), section 211 or section 221(a), shall be permitted to purchase supplies from the Army, Navy, Air
p.000001: Force, and Marine Corps at the same price as is charged officers thereof.
p.000001: (c) Members of the National Advisory Health Council and members of other national advisory or review
p.000001: councils or commit- tees established under this Act, including members of the Technical Electronic Product Radiation
p.000001: Safety Standards Committee and the Board of Regents of the National Library of Medicine, but exclud- ing ex
p.000001: officio members, while attending conferences or meetings of their respective councils or committees or while
p.000001: otherwise serving at the request of the Secretary shall be entitled to receive com- pensation at rates to
p.000001: be fixed by the Secretary, but at rates not ex- ceeding the daily equivalent of the rate specified at the
p.000001: time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from
p.000001: their homes or regular places of business they may be allowed travel expenses, including per diem in lieu
p.000001: of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government
p.000001: service em- ployed intermittently.
p.000001: (d) Field employees of the Service, except those employed on a
p.000001: per diem or fee basis, who render part-time duty and are also sub- ject to call at any time for services not
p.000001: contemplated in their reg- ular part-time employment, may be paid annual compensation for such part-time
p.000001: duty and, in addition, such fees for such other serv- ices as the Surgeon General may determine; but in no
p.000001: case shall the total paid to any such employee for any fiscal year exceed the
...

p.000001: years of service credited to an officer is counted as one-twelfth of a year and any remaining fractional part of a
p.000001: month is disregarded.
p.000001: (f) For purposes of retirement or separation for physical dis- ability under chapter 61 of title 10, United
p.000001: States Code, a commis- sioned officer of the Service shall be credited, in addition to the service described
p.000001: in section 1208(a)(2) of that title, with active serv- ice with the Public Health Service, other than as a
p.000001: commissioned officer, which the Surgeon General determines is comparable to service performed by
p.000001: commissioned officers of the Service, except that, if there are more than five years of such service, only the
p.000001: last five years thereof may be so credited. For such purposes, such sec- tion 1208(a)(2) shall be applicable to
p.000001: officers of the Regular or Re- serve Corps of the Service.
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: MILITARY BENEFITS
p.000001: SEC. 212. ø213¿ (a) Except as provided in subsection (b), com- missioned officers of the Service and their
p.000001: surviving beneficiaries shall, with respect to active service performed by such officers—
p.000001: (1) in time of war;
p.000001: (2) on detail for duty with the Army, Navy, Air Force, Ma- rine Corps, or Coast Guard; or
p.000001: (3) while the Service is part of the military forces of the United States pursuant to Executive order of the
p.000001: President;
p.000001: be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law
p.000001: of the United States in the case of commissioned officers of the Army or their surviving bene- ficiaries
p.000001: on account of active military service, except retired pay and uniform allowances.
p.000001: (b) The President may prescribe the conditions under which commissioned officers of the Service may be
p.000001: awarded military rib- bons, medals, and decorations.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 213 PUBLIC HEALTH SERVICE ACT 20
p.000001:
p.000001: (c) The authority vested by law in the Department of the Army, the Secretary of the Army, or other
p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
...

p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
p.000001: applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive
p.000001: depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for
p.000001: the government of the service to which detailed.
p.000001: (b) Upon the request of any State health authority or, in the case of work relating to mental health, any
p.000001: State mental health au-
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 7 Former section 213 was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Section 415(c) of title 37, United
p.000001: States Code, now applies to the matter with which former section 213 was concerned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: 21 PUBLIC HEALTH SERVICE ACT Sec. 216
p.000001:
p.000001: thority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such
p.000001: State or political subdivi- sion thereof in work related to the functions of the Service.
p.000001: (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to
p.000001: nonprofit edu- cational research or other institutions engaged in health activities for special studies of
p.000001: scientific problems and for the dissemination of information relating to public health.
p.000001: (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the
...

p.000001:
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p.000001: January 30, 2020
p.000001:
p.000001: PROMOTION CREDIT—ASSISTANT GRADE
p.000001: SEC. 220. ø211c¿ Any medical officer of the Regular Corps of the Public Health Service who—
p.000001: (1)(A) was appointed to the assistant grade in the Regular Corps and whose service in such Corps has been
p.000001: continuous from the date of appointment or (B) may hereafter be ap- pointed to the assistant grade in the
p.000001: Regular Corps, and
p.000001: (2) had or will have completed a medical internship on the date of such appointment,
p.000001: shall be credited with one year for purposes of promotion and se- niority in grade, except that no
p.000001: such credit shall be authorized if the officer has received or will receive similar credit for his intern- ship
p.000001: under other provisions of law. In the case of an officer on ac- tive duty on the effective date of this section who is
p.000001: entitled to the credit authorized herein, the one year shall be added to the pro- motion and
p.000001: seniority-in-grade credits with which he is credited on such date.
p.000001: RIGHTS, PRIVILEGES, ETC. OF OFFICERS AND SURVIVING BENEFICIARIES
p.000001: SEC. 221. ø213a¿ (a) Commissioned officers of the Service or their surviving beneficiaries are entitled to all
p.000001: the rights, benefits, privileges, and immunities now or hereafter provided for commis- sioned officers of
p.000001: the Army or their surviving beneficiaries under the following provisions of title 10, United States Code:
p.000001: (1) Section 1036, Escorts for dependents of members: transportation and travel allowances.
p.000001: (2) Chapter 61, Retirement or Separation for Physical Dis- ability, except that sections 1201, 1202, and 1203 do not
p.000001: apply to commissioned officers of the Public Health Service who have been ordered to active duty for training
p.000001: for a period of more than 30 days.
p.000001: (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a).
p.000001: (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401.
p.000001: (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan.
p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
...

p.000765: feasibly be developed into a regional medical library adequate to serve such area,
p.000765: the Secretary may establish, as a branch of the Library, a regional medical library to serve the needs of such area.
p.000765: (f) Section 231 shall be applicable to the acceptance and admin- istration of gifts made for the benefit of the Library
p.000765: or for carrying out any of its functions, and the Board of Regents shall make rec- ommendations to the Secretary
p.000765: relating to establishment within the Library of suitable memorials to the donors.
p.000765: (g) For purposes of this part, the terms ‘‘medicine’’ and ‘‘med- ical’’, except when used in section
p.000765: 466, include preventive and therapeutic medicine, dentistry, pharmacy, hospitalization, nurs- ing, public
p.000765: health, and the fundamental sciences related thereto, and other related fields of study, research, or activity.
p.000765:
p.000765:
p.000765: January 30, 2020 As Amended Through P.L. 116-94,
p.000765: Enacted December 20, 2019
p.000765:
p.000765:
p.000765:
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p.000765:
p.000765:
p.000767: 767
p.000767: PUBLIC HEALTH SERVICE ACT
p.000767: Sec. 467
p.000767:
p.000767: BOARD OF REGENTS
p.000767: SEC. 466. ø286a¿ (a)(1)(A) The Board of Regents of the Na- tional Library of Medicine consists of ex
p.000767: officio members and ten members appointed by the Secretary.
p.000767: (B) The ex officio members are the Surgeons General of the Public Health Service, the Army, the Navy, and the
p.000767: Air Force, the Chief Medical Director of the Department of Veterans Affairs, the Dean of the Uniformed
p.000767: Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social
p.000767: Sciences of the National Science Foundation, the Director of the National Agricultural Library, and the
p.000767: Librarian of Congress (or their designees).
p.000767: (C) The appointed members shall be selected from among lead- ers in the various fields of the fundamental sciences,
p.000767: medicine, den- tistry, public health, hospital administration, pharmacology, health communications technology, or
p.000767: scientific or medical library work, or in public affairs. At least six of the appointed members shall be se- lected
p.000767: from among leaders in the fields of medical, dental, or public health research or education.
p.000767: (2) The Board shall annually elect one of the appointed mem- bers to serve as chairman until the next
p.000767: election. The Secretary shall designate a member of the Library staff to act as executive secretary of the
p.000767: Board.
p.000767: (b) The Board shall advise, consult with, and make rec- ommendations to the Secretary on matters
p.000767: of policy in regard to the Library, including such matters as the acquisition of materials for the Library, the
p.000767: scope, content, and organization of the Li- brary’s services, and the rules under which its materials,
p.000767: publica- tions, facilities, and services shall be made available to various kinds of users. The Secretary
p.000767: shall include in the annual report of the Secretary to the Congress a statement covering the rec-
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p.000001: of years of active service (as defined in section 211(d)) equal to the number of years by which his
p.000001: age exceeds forty-four, or (B) the Surgeon General determines that he possesses exceptional qualifications, not
p.000001: readily available elsewhere in the Commissioned Corps of the Public Health Service, for the perform- ance of
p.000001: special duties with the Service, or (C) in the case of an offi-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 9 PUBLIC HEALTH SERVICE ACT Sec. 207
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: cer of the Reserve Corps, the Commissioned Corps of the Service has been declared by the President to be a
p.000001: military service.
p.000001: (b)(1) Not more than 10 per centum of the original appoint- ments to the Regular Corps authorized to be made
p.000001: during any fis- cal year may be made to grades above that of senior assistant, but no such appointment (other than
p.000001: an appointment under section
p.000001: 204) may be made to a grade above that of director. For the pur- pose of this subsection the number
p.000001: of original appointments au- thorized to be made during a fiscal year shall be (1) the excess of the
p.000001: number of officers of the Regular Corps authorized by the ap- propriation Act or Acts for such year
p.000001: over the number of officers on active duty in the Regular Corps on the first day of such year, plus
p.000001: (2) the number of such officers of the Regular Corps who, dur- ing such fiscal year, have been or will be
p.000001: retired upon attainment of age sixty-four or have for any other reason ceased to be on active duty. In determining
p.000001: the number of appointments authorized by this subsection an appointment shall be deemed to be made in the fiscal
p.000001: year in which the nomination is transmitted by the President to the Senate.
p.000001: (2) In addition to the number of original appointments to the Regular Corps authorized by paragraph (1)
p.000001: to be made to grades above that of senior assistant, original appointments authorized to be made to the Regular
p.000001: Corps in any year may be made to grades above that of senior assistant, but not above that of director, in the case of
p.000001: any individual who—
p.000001: (A)(i) was on active duty in the Regular Corps on July 1, 1960, (ii) was on such active duty
...

p.000001: included.
p.000001: (e) For the purpose of determining the number of years by which a percentage of the basic pay of an officer
p.000001: is to be multiplied in computing the amount of his retired pay pursuant to section 210(g)(3) or paragraph (4)
p.000001: of subsection (a) of this section, each full month of service that is in addition to the number of full
p.000001: years of service credited to an officer is counted as one-twelfth of a year and any remaining fractional part of a
p.000001: month is disregarded.
p.000001: (f) For purposes of retirement or separation for physical dis- ability under chapter 61 of title 10, United
p.000001: States Code, a commis- sioned officer of the Service shall be credited, in addition to the service described
p.000001: in section 1208(a)(2) of that title, with active serv- ice with the Public Health Service, other than as a
p.000001: commissioned officer, which the Surgeon General determines is comparable to service performed by
p.000001: commissioned officers of the Service, except that, if there are more than five years of such service, only the
p.000001: last five years thereof may be so credited. For such purposes, such sec- tion 1208(a)(2) shall be applicable to
p.000001: officers of the Regular or Re- serve Corps of the Service.
p.000001:
p.000001:
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p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: MILITARY BENEFITS
p.000001: SEC. 212. ø213¿ (a) Except as provided in subsection (b), com- missioned officers of the Service and their
p.000001: surviving beneficiaries shall, with respect to active service performed by such officers—
p.000001: (1) in time of war;
p.000001: (2) on detail for duty with the Army, Navy, Air Force, Ma- rine Corps, or Coast Guard; or
p.000001: (3) while the Service is part of the military forces of the United States pursuant to Executive order of the
p.000001: President;
p.000001: be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law
p.000001: of the United States in the case of commissioned officers of the Army or their surviving bene- ficiaries
p.000001: on account of active military service, except retired pay and uniform allowances.
p.000001: (b) The President may prescribe the conditions under which commissioned officers of the Service may be
p.000001: awarded military rib- bons, medals, and decorations.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 213 PUBLIC HEALTH SERVICE ACT 20
p.000001:
p.000001: (c) The authority vested by law in the Department of the Army, the Secretary of the Army, or other
p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
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p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
p.000001:
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p.000001:
p.000001:
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p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
p.000001: SEC. 216. ø217¿ In time of war, or of emergency proclaimed by the President, he may utilize the Service to such
p.000001: extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency
p.000001: involving the national defense pro-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 217 PUBLIC HEALTH SERVICE ACT 22
p.000001:
p.000001: claimed by the President, he may by Executive order declare the commissioned corps of the Service to be
p.000001: a military service. Upon such declaration, and during the period of such war or such emer- gency or such part
p.000001: thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the
p.000001: land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President,
p.000001: be subject to the Uniform Code of Military Justice, and (c) shall continue to operate as part of the
p.000001: Service except to the extent that the President may direct as Com- mander in Chief.
p.000001:
p.000001: NATIONAL ADVISORY COUNCILS
p.000001: SEC. 217. ø218¿ (a) Within 120 days of the date of the enact- ment of this subsection, the Secretary
p.000001: shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred
p.000001: to as the Council) which shall advise, consult with, and make recommendations to, the Secretary on matters con-
p.000001: cerning the organization, operation, selection, and funding of mi- grant health centers and other entities
p.000001: under grants and contracts under section 329. 8
p.000001: (b) The Council shall consist of fifteen members, at least twelve of whom shall be members of the governing
p.000001: boards of migrant health centers or other entities assisted under section 329. 8 Of such twelve members
p.000001: who are members of such governing boards, at least nine shall be chosen from among those members of
p.000001: such governing boards who are being served by such centers or grantees and who are familiar with the delivery of health
p.000001: care to migratory agricultural workers and seasonal agricultural workers. The re- maining three Council
p.000001: members shall be individuals qualified by training and experience in the medical sciences or in the adminis-
p.000001: tration of health programs.
p.000001: (c) Each member of the Council shall hold office for a term of four years, except that (1) any member
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p.000001: entitled to the credit authorized herein, the one year shall be added to the pro- motion and
p.000001: seniority-in-grade credits with which he is credited on such date.
p.000001: RIGHTS, PRIVILEGES, ETC. OF OFFICERS AND SURVIVING BENEFICIARIES
p.000001: SEC. 221. ø213a¿ (a) Commissioned officers of the Service or their surviving beneficiaries are entitled to all
p.000001: the rights, benefits, privileges, and immunities now or hereafter provided for commis- sioned officers of
p.000001: the Army or their surviving beneficiaries under the following provisions of title 10, United States Code:
p.000001: (1) Section 1036, Escorts for dependents of members: transportation and travel allowances.
p.000001: (2) Chapter 61, Retirement or Separation for Physical Dis- ability, except that sections 1201, 1202, and 1203 do not
p.000001: apply to commissioned officers of the Public Health Service who have been ordered to active duty for training
p.000001: for a period of more than 30 days.
p.000001: (3) Chapter 69, Retired Grade, except sections 1370, 1374, 1375, and 1376(a).
p.000001: (4) Chapter 71, Computation of Retired Pay, except for- mula No. 3 of section 1401.
p.000001: (5) Chapter 73, Retired Serviceman’s Family Protection Plan, Survivor Benefit Plan.
p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
p.000001: full-time employees of the United States shall, while attending meetings or conferences of such council or
p.000001: committee or otherwise engaged on business of such council or committee receive compensation and allowances as
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p.000017: (2) consider the recommendations of national and local public-health organizations for improving the
p.000017: survival rates of individuals who experience cardiac arrest in nonhospital set- tings by minimizing the
p.000017: time elapsing between the onset of
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 20 Public Law 105–12 (111 Stat. 23).
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017: 57 PUBLIC HEALTH SERVICE ACT Sec. 248
p.000017:
p.000017: cardiac arrest and the initial medical response, including defibrillation as necessary; and
p.000017: (3) consult with and counsel other Federal agencies where such devices are to be used.
p.000017: (d) DATE CERTAIN FOR ESTABLISHING GUIDELINES AND REC- OMMENDATIONS.—The Secretary shall comply with
p.000017: this section not later than 180 days after the date of the enactment of the Cardiac Arrest Survival Act of 2000.
p.000017: (e) DEFINITIONS.—For purposes of this section:
p.000017: (1) The term ‘‘automated external defibrillator device’’ has the meaning given such term in section 248.
p.000017: (2) The term ‘‘Federal building’’ includes a building or por- tion of a building leased or rented by a Federal agency,
p.000017: and in- cludes buildings on military installations of the United States.
p.000017:
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p.000017: January 30, 2020
p.000017: LIABILITY REGARDING EMERGENCY USE OF AUTOMATED EXTERNAL DEFIBRILLATORS
p.000017: SEC. 248. ø238q¿ (a) GOOD SAMARITAN PROTECTIONS REGARD-
p.000017: ING AEDS.—Except as provided in subsection (b), any person who uses or attempts to use an automated
p.000017: external defibrillator device on a victim of a perceived medical emergency is immune from civil liability for any
p.000017: harm resulting from the use or attempted use of such device; and in addition, any person who acquired
p.000017: the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device—
p.000017: (1) to notify local emergency response personnel or other appropriate entities of the most recent placement of
p.000017: the device within a reasonable period of time after the device was placed;
p.000017: (2) to properly maintain and test the device; or
p.000017: (3) to provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee
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p.000017: a total of 12 months).
p.000017: (c) SECOND 2 YEARS OF SERVICE.—During the third and fourth years in which a medical, dental, physician
p.000017: assistant, pharmacy, behavioral and mental health, public health, or nursing student is enrolled in the Track,
p.000017: training should be designed to prioritize clin- ical rotations in Federal medical facilities in health
p.000017: professional shortage areas, and emphasize a balance of hospital and commu- nity-based experiences, and
p.000017: training within interdisciplinary teams.
p.000017: (d) DENTIST, PHYSICIAN ASSISTANT, PHARMACIST, BEHAVIORAL AND MENTAL HEALTH PROFESSIONAL, PUBLIC
p.000017: HEALTH PROFES- SIONAL, AND NURSE TRAINING.—The Surgeon General shall estab- lish provisions applicable
p.000017: with respect to dental, physician assist- ant, pharmacy, behavioral and mental health, public health, and
p.000017: nursing students that are comparable to those for medical students under this section, including service
p.000017: obligations, tuition support, and stipend support. The Surgeon General shall give priority to health
p.000017: professions training institutions that train medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, pub- lic health, and nursing students for some significant period of time together, but at a minimum
p.000017: have a discrete and shared core cur- riculum.
p.000017: (e) ELITE FEDERAL DISASTER TEAMS.—The Surgeon General, in consultation with the Secretary, the Director of the Centers
p.000017: for Dis- ease Control and Prevention, and other appropriate military and Federal government agencies, shall
p.000017: develop criteria for the appoint- ment of highly qualified Track faculty, medical, dental, physician assistant,
p.000017: pharmacy, behavioral and mental health, public health, and nursing students, and graduates to elite
p.000017: Federal disaster pre- paredness teams to train and to respond to public health emer- gencies, natural
p.000017: disasters, bioterrorism events, and other emer- gencies.
p.000017: (f) STUDENT DROPPED FROM TRACK IN AFFILIATE SCHOOL.—A medical, dental, physician assistant, pharmacy,
p.000017: behavioral and mental health, public health, or nursing student who, under regu- lations prescribed by
p.000017: the Surgeon General, is dropped from the Track in an affiliated school for deficiency in conduct or studies, or
p.000017: for other reasons, shall be liable to the United States for all tuition and stipend support provided to the student.
p.000017: SEC. 274. ø239l–3¿ FUNDING.
p.000017: Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services
p.000017: Emergency Fund such sums as may be necessary to carry out this part.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 73 PUBLIC HEALTH SERVICE ACT Sec. 301
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p.000017: (1) collect and make available through publications and other appropriate means, information as to, and
p.000017: the practical application of, such research and other activities;
p.000017: (2) make available research facilities of the Service to ap- propriate public authorities, and to health
p.000017: officials and sci- entists engaged in special study;
p.000017: (3) make grants-in-aid to universities, hospitals, labora- tories, and other public or private
p.000017: institutions, and to individ- uals for such research projects as are recommended by the ad- visory council to the
p.000017: entity of the Department supporting such projects and make, upon recommendation of the advisory coun- cil to the
p.000017: appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals,
p.000017: laboratories, and other institutions for the general support of their research;
p.000017: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000017: experts, scholars, and consultants from the United States or abroad;
p.000017: (5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons
p.000017: not otherwise el- igible for such treatment;
p.000017: (6) make available, to health officials, scientists, and ap- propriate public and other nonprofit institutions
p.000017: and organiza- tions, technical advice and assistance on the application of sta- tistical methods to experiments,
p.000017: studies, and surveys in health and medical fields;
p.000017: (7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law
p.000017: applicable to contracts entered into by the military departments under title 10, United States Code,
p.000017: sections 2353 and 2354, except that determination, approval, and certification required there- by shall be by
p.000017: the Secretary of Health, Education, and Welfare; and
p.000017:
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p.000017: January 30, 2020
p.000017: (8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department
p.000017: or, with respect to mental health, the National Advisory Mental Health Coun- cil, such additional means as
p.000017: the Secretary considers necessary or appropriate to carry out the purposes of this section.
p.000017: (b)(1) The Secretary shall conduct and may support through grants and contracts studies and testing of
p.000017: substances for carcino-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 301 PUBLIC HEALTH SERVICE ACT 74
p.000017:
p.000017: genicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the
p.000017: Secretary shall consult with entities of the Federal Government, outside of the Department of Health, Education, and
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p.000017: January 30, 2020
p.000017:
p.000017: Project Grants for Training, Studies, and Demonstrations
p.000017: (c) The Secretary is also authorized, during the period begin- ning July 1, 1966, and ending June 30, 1974, to
p.000017: make grants to any public or nonprofit private agency, institution, or other organiza- tion to cover all or
p.000017: any part of the cost of projects for training, studies, or demonstrations looking toward the development
p.000017: of im- proved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out
p.000017: this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June
p.000017: 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30,
p.000017: 1969,
p.000017: $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000
p.000017: for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and
p.000017: $4,700,000 for the fiscal year ending June 30, 1974.
p.000017: SEC. 315. ø42 U.S.C. 247¿ ASSISTING VETERANS WITH MILITARY EMER- GENCY MEDICAL TRAINING TO MEET REQUIREMENTS
p.000017: FOR BECOMING CIVILIAN HEALTH CARE PROFES- SIONALS.
p.000017: (a) PROGRAM.—
p.000017: (1) IN GENERAL.—The Secretary may establish a program, in consultation with the Secretary of Labor,
p.000017: consisting of awarding demonstration grants to States to streamline State requirements and procedures in
p.000017: order to assist veterans who held certain military occupational specialties related to medical care or who have
p.000017: completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification,
p.000017: licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni-
p.000017: cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician
p.000017: assistant professions) in the State.
p.000017: (2) CONSULTATION AND COLLABORATION.—In determining the eligible military occupational specialties or training
p.000017: courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of
p.000017: Defense, the Sec- retary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’
p.000017: Employment and Training, and shall col- laborate with the initiatives carried out under section 4114 of
p.000017: title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code.
p.000017: (b) USE OF FUNDS.—Amounts received as a demonstration grant under this section shall be used to—
p.000017: (1) prepare and implement a plan to streamline State re- quirements and procedures as described in
p.000017: subsection (a), in- cluding by—
p.000017: (A) determining the extent to which the requirements for the education, training, and skill level of civilian
p.000017: health care professions (such as emergency medical technicians, paramedics, licensed practical nurses,
p.000017: registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to
p.000017: requirements for the education, training, and skill level of veterans who served in medical
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 99 PUBLIC HEALTH SERVICE ACT Sec. 317
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p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
p.000441: SEC. 363. 73 ø266¿ To protect the military and naval forces and war workers of the United States, in time of war,
p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
p.000441: prehension and examination, in time of war, of any individual rea- sonably believed (1) to be infected with such
p.000441: disease and (2) to be a probable source of infection to members of the armed forces of the
p.000441:
p.000441:
p.000441:
p.000441:
p.000441: January 30, 2020
p.000441: 73 Under section 3 of Public Law 239, 80th Congress, the date of July 25, 1947, is deemed, for purposes
p.000441: of this section, to be the date of termination of ‘‘any state of war heretofore declared by the Congress’’.
p.000441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000441: Sec. 364 PUBLIC HEALTH SERVICE ACT 442
p.000441:
p.000441: United States or to individuals engaged in the production or trans- portation of arms, munitions, ships, food,
p.000441: clothing, or other supplies for the armed forces. Such regulations may provide that if upon ex- amination any such
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p.000475: individuals with academic institutions to conduct applied research that will support the development of such
p.000475: surveillance systems and registries as may be necessary. A surveillance system or registry under this
p.000475: section shall provide for the collection of data con- cerning—
p.000475: (1) demographic information about each traumatic brain injury;
p.000475: (2) information about the circumstances surrounding the injury event associated with each traumatic brain injury;
p.000475: (3) administrative information about the source of the col- lected information, dates of hospitalization and treatment,
p.000475: and the date of injury; and
p.000475: (4) information characterizing the clinical aspects of the traumatic brain injury, including the severity
p.000475: of the injury, outcomes of the injury, the types of treatments received, and the types of services utilized.
p.000475: (b) Not later than 18 months after the date of enactment of the Traumatic Brain Injury Act of 2008, the Secretary,
p.000475: acting through the Director of the Centers for Disease Control and Prevention and the Director of the National
p.000475: Institutes of Health and in consulta- tion with the Secretary of Defense and the Secretary of Veterans
p.000475: Affairs, shall submit to the relevant committees of Congress a re- port that contains the findings
p.000475: derived from an evaluation con- cerning activities and procedures that can be implemented by the Centers
p.000475: for Disease Control and Prevention to improve the collec- tion and dissemination of compatible epidemiological
p.000475: studies on the incidence and prevalence of traumatic brain injury in individuals who were formerly in the
p.000475: military. The report shall include rec- ommendations on the manner in which such agencies can further
p.000475: collaborate on the development and improvement of traumatic brain injury diagnostic tools and treatments.
p.000475: (c) NATIONAL CONCUSSION DATA COLLECTION AND ANALYSIS.— The Secretary, acting through the Director of the
p.000475: Centers for Dis- ease Control and Prevention, may implement concussion data col- lection and analysis to
p.000475: determine the prevalence and incidence of concussion.
p.000475: SEC. 393D. ø28b–1f¿ PREVENTION OF FALLS AMONG OLDER ADULTS.
p.000475: (a) PUBLIC EDUCATION.—The Secretary may—
p.000475: (1) oversee and support a national education campaign to be carried out by a nonprofit organization with
p.000475: experience in
p.000475:
p.000475:
p.000475:
p.000475:
p.000475: January 30, 2020
p.000475: 88 The amendment by section 2(3) of Public Law 110–206 to redesignate section 393B (relating to traumatic brain injury
p.000475: registeries) as section 393C could not be executed because such section had already been redesignated as section 393C
p.000475: by section 2(1) of Public Law 110–202.
p.000475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000477: PUBLIC HEALTH SERVICE ACT
p.000477: Sec. 393D
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p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: 857
p.000857: PUBLIC HEALTH SERVICE ACT
p.000857: Sec. 513
p.000857:
p.000857: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000857: programs to dissemi- nate and apply the findings of the knowledge development and ap- plication, training and technical
p.000857: assistance programs, and targeted capacity response programs under this section to the general pub- lic, to
p.000857: health professionals and other interested groups. The Sec- retary shall make every effort to provide linkages
p.000857: between the find- ings of supported projects and State agencies responsible for car- rying out substance
p.000857: use disorder prevention and treatment pro- grams.
p.000857: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000857: $333,806,000 for each of fiscal years 2018 through 2022.
p.000857: ACTION BY NATIONAL INSTITUTE ON DRUG ABUSE AND STATES CONCERNING MILITARY FACILITIES
p.000857: SEC. 513. 7 ø290bb–6¿ (a) CENTER FOR SUBSTANCE ABUSE
p.000857: TREATMENT.—The Director of the Center for Substance Abuse Treatment shall—
p.000857: (1) coordinate with the agencies represented on the Com- mission on Alternative Utilization of Military
p.000857: Facilities the uti- lization of military facilities or parts thereof, as identified by such Commission,
p.000857: established under the National Defense Au- thorization Act of 1989, that could be utilized or renovated to
p.000857: house nonviolent persons for drug treatment purposes;
p.000857: (2) notify State agencies responsible for the oversight of drug abuse treatment entities and programs of the
p.000857: availability of space at the installations identified in paragraph (1); and
p.000857: (3) assist State agencies responsible for the oversight of drug abuse treatment entities and programs in
p.000857: developing methods for adapting the installations described in paragraph
p.000857: (1) into residential treatment centers.
p.000857: (b) STATES.—With regard to military facilities or parts thereof, as identified by the Commission on Alternative
p.000857: Utilization of Mili- tary Facilities established under section 3042 of the Comprehensive Alcohol Abuse, Drug Abuse,
p.000857: and Mental Health Amendments Act of 1988, that could be utilized or renovated to house nonviolent per- sons for
p.000857: drug treatment purposes, State agencies responsible for the oversight of drug abuse treatment
p.000857: entities and programs shall—
p.000857: (1) establish eligibility criteria for the treatment of individ- uals at such facilities;
p.000857: (2) select treatment providers to provide drug abuse treat- ment at such facilities;
p.000857: (3) provide assistance to treatment providers selected under paragraph (2) to assist such providers
p.000857: in securing fi- nancing to fund the cost of the programs at such facilities; and
p.000857: (4) establish, regulate, and coordinate with the military of- ficial in charge of the facility, work programs
p.000857: for individuals receiving treatment at such facilities.
p.000857:
p.000857:
p.000857:
p.000857:
p.000857: January 30, 2020
p.000857: 7 Sections 510 through 512 were repealed by section 3301(c) of Public Law 106–310 (114 Stat.
p.000857: 1209).
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000857:
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p.000857: Sec. 514 PUBLIC HEALTH SERVICE ACT 858
p.000857:
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p.000857: January 30, 2020
p.000857:
p.000857: (c) RESERVATION OF SPACE.—Prior to notifying States of the availability of space at military facilities
p.000857: under subsection (a)(2), the Director may reserve space at such facilities to conduct re- search or
p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
...

p.000977: funds fully owned by the lender or from funds held by the lender in a trust or similar capacity and
p.000977: available for such loans.
p.000977: SEC. 705. ø292d¿ ELIGIBILITY OF BORROWERS AND TERMS OF IN- SURED LOANS.
p.000977: (a) IN GENERAL.—A loan by an eligible lender shall be insur- able by the Secretary under the provisions of
p.000977: this subpart only if—
p.000977: (1) made to—
p.000977: (A) a student who—
p.000977: (i)(I) has been accepted for enrollment at an eligi- ble institution, or (II) in the case of a student attend-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000979: 979
p.000979: PUBLIC HEALTH SERVICE ACT
p.000979: Sec. 705
p.000979:
p.000979: ing an eligible institution, is in good standing at that institution, as determined by the institution;
p.000979: (ii) is or will be a full-time student at the eligible institution;
p.000979: (iii) has agreed that all funds received under such loan shall be used solely for tuition, other reasonable
p.000979: educational expenses, including fees, books, and lab- oratory expenses, and reasonable living expenses, in-
p.000979: curred by such students;
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section; and
p.000979: (v) in the case of a pharmacy student, has satis- factorily completed three years of training; or
p.000979: (B) an individual who—
p.000979: (i) has previously had a loan insured under this subpart when the individual was a full-time student at an
p.000979: eligible institution;
p.000979: (ii) is in a period during which, pursuant to para- graph (2), the principal amount of such previous loan need
p.000979: not be paid;
p.000979: (iii) has agreed that all funds received under the proposed loan shall be used solely for repayment of in-
p.000979: terest due on previous loans made under this subpart; and
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section;
p.000979: (2) evidenced by a note or other written agreement which—
p.000979:
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p.000979: January 30, 2020
p.000979: (A) is made without security and without endorse- ment, except that if the borrower is a minor and such note or
p.000979: other written agreement executed by him would not, under the applicable law, create a binding obligation,
p.000979: an endorsement may be required;
p.000979: (B) provides for repayment of the principal amount of the loan in installments over a period of not
p.000979: less than 10 years (unless sooner repaid) nor more than 25 years begin- ning not earlier than 9 months nor
p.000979: later than 12 months after the date of—
p.000979: (i) the date on which—
p.000979: (I) the borrower ceases to be a participant in an accredited internship or residency program of not more
p.000979: than four years in duration;
p.000979: (II) the borrower completes the fourth year of an accredited internship or residency program of more than four
p.000979: years in duration; or
p.000979: (III) the borrower, if not a participant in a program described in subclause (I) or (II), ceases to
p.000979: carry, at an eligible institution, the normal full-
p.000979: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000979:
p.000979:
p.000979:
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p.000997: stitution).
p.000997: (2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For purposes of paragraph (1), the amount of the loan may,
p.000997: in the case of the third or fourth year of a student at a school of med- icine or osteopathic medicine, be
p.000997: increased to the extent nec- essary to pay the balances of loans that, from sources other than the
p.000997: student loan fund under section 721, were made to the individual for attendance at the school. The
p.000997: authority to make such an increase is subject to the school and the student agreeing that such amount (as
p.000997: increased) will be expended to pay such balances.
p.000997: (b) TERMS AND CONDITIONS.—Subject to section 723, any such loans shall be made on such terms and
p.000997: conditions as the school may determine, but may be made only to a student—
p.000997: (1) who is in need of the amount thereof to pursue a full- time course of study at the school leading to a
p.000997: degree of doctor of medicine, doctor of dentistry or an equivalent degree, doctor of osteopathy, bachelor of science in
p.000997: pharmacy or an equivalent degree, doctor of pharmacy or an equivalent degree, doctor of podiatric medicine or
p.000997: an equivalent degree, doctor of optometry or an equivalent degree, or doctor of veterinary medicine or an equivalent
p.000997: degree; and
p.000997: (2) who, if required under section 3 of the Military Selec- tive Service Act to present himself for
p.000997: and submit to registra- tion under such section, has presented himself and submitted to registration under
p.000997: such section.
p.000997: (c) REPAYMENT; EXCLUSIONS FROM REPAYMENT PERIOD.—Such loans shall be repayable in equal or graduated
p.000997: periodic install- ments (with the right of the borrower to accelerate repayment) over the period of not less than 10
p.000997: years nor more than 25 years, at the discretion of the institution, which begins one year after the stu- dent
p.000997: ceases to pursue a full-time course of study at a school of med- icine, osteopathic medicine, dentistry, pharmacy,
p.000997: podiatry, optom- etry, or veterinary medicine, excluding from such period—
p.000997: (1) all periods—
p.000997: (A) not in excess of three years of active duty per- formed by the borrower as a member of a uniformed serv-
p.000997: ice;
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p.000997: January 30, 2020
p.000997: (B) not in excess of three years during which the bor- rower serves as a volunteer under the Peace Corps Act;
p.000997: (C) during which the borrower participates in ad- vanced professional training, including
p.000997: internships and residencies; and
p.000997: (D) during which the borrower is pursuing a full-time course of study at such a school; and
p.000997: (2) a period—
p.000997: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001211: 1211
p.001211: PUBLIC HEALTH SERVICE ACT
p.001211: Sec. 1291
p.001211:
p.001211: (1) LESS THAN $10,000,000.—If the amount of appropriations for this part in a fiscal year is less than $10,000,000,
p.001211: the Sec- retary shall divide such funding evenly among only those States that have 1 or more trauma
p.001211: centers eligible for funding under section 1241(b)(3)(A).
p.001211: (2) LESS THAN $20,000,000.—If the amount of appropriations in a fiscal year is less than $20,000,000, the Secretary
p.001211: shall di- vide such funding evenly among only those States that have 1 or more trauma centers eligible for
p.001211: funding under subpara- graphs (A) and (B) of section 1241(b)(3).
p.001211: (3) LESS THAN $30,000,000.—If the amount of appropriations for this part in a fiscal year is less than $30,000,000,
p.001211: the Sec- retary shall divide such funding evenly among only those States that have 1 or more trauma
p.001211: centers eligible for funding under section 1241(b)(3).
p.001211: (4) $30,000,000 OR MORE.—If the amount of appropriations for this part in a fiscal year is $30,000,000 or
p.001211: more, the Sec- retary shall divide such funding evenly among all States.
p.001211: SEC. 1282. ø300d–82¿ AUTHORIZATION OF APPROPRIATIONS.
p.001211: For the purpose of carrying out this part, there is authorized to be appropriated $100,000,000 for
p.001211: each of fiscal years 2010 through 2015.
p.001211:
p.001211: PART I—MILITARY AND CIVILIAN PARTNER- SHIP FOR TRAUMA READINESS GRANT PRO- GRAM
p.001211:
p.001211: SEC. 1291. ø300d–91¿ MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM.
p.001211: (a) MILITARY TRAUMA TEAM PLACEMENT PROGRAM.—
p.001211: (1) IN GENERAL.—The Secretary, acting through the Assist- ant Secretary for Preparedness and Response and in consulta-
p.001211: tion with the Secretary of Defense, shall award grants to not more than 20 eligible high-acuity trauma
p.001211: centers to enable military trauma teams to provide, on a full-time basis, trauma care and related acute care at such
p.001211: trauma centers.
p.001211: (2) LIMITATIONS.—In the case of a grant awarded under paragraph (1) to an eligible high-acuity trauma
p.001211: center, such grant—
p.001211:
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p.001211: January 30, 2020
p.001211: (A) shall be for a period of at least 3 years and not more than 5 years (and may be renewed at the end of
p.001211: such period); and
p.001211: (B) shall be in an amount that does not exceed
p.001211: $1,000,000 per year.
p.001211: (3) AVAILABILITY OF FUNDS.—Notwithstanding section 1552 of title 31, United States Code, or any other
p.001211: provision of law, funds available to the Secretary for obligation for a grant under this subsection shall
p.001211: remain available for expenditure for 100 days after the last day of the performance period of such
p.001211: grant.
p.001211: (b) MILITARY TRAUMA CARE PROVIDER PLACEMENT PROGRAM.—
p.001211: (1) IN GENERAL.—The Secretary, acting through the Assist- ant Secretary for Preparedness and Response and in consulta-
p.001211: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001211:
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p.001211: Sec. 1291 PUBLIC HEALTH SERVICE ACT 1212
p.001211:
p.001211: tion with the Secretary of Defense, shall award grants to eligi- ble trauma centers to enable military trauma care
p.001211: providers to provide trauma care and related acute care at such trauma centers.
p.001211: (2) LIMITATIONS.—In the case of a grant awarded under paragraph (1) to an eligible trauma center, such grant—
p.001211: (A) shall be for a period of at least 1 year and not more than 3 years (and may be renewed at the end of
p.001211: such period); and
p.001211: (B) shall be in an amount that does not exceed, in a year—
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p.001211: (i) $100,000 for each military trauma care pro- vider that is a physician at such eligible trauma cen-
p.001211: ter; and
p.001211: (ii) $50,000 for each other military trauma care provider at such eligible trauma center.
p.001211: (c) GRANT REQUIREMENTS.—
p.001211: (1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As a condition of receipt of a grant under this section, a
p.001211: grant re- cipient shall agree to allow military trauma care providers pro- viding care pursuant to such grant to—
p.001211: (A) be deployed by the Secretary of Defense for mili- tary operations, for training, or for response to a mass
p.001211: cas- ualty incident; and
p.001211: (B) be deployed by the Secretary of Defense, in con- sultation with the Secretary of Health and Human
p.001211: Serv- ices, for response to a public health emergency pursuant to section 319.
p.001211: (2) USE OF FUNDS.—Grants awarded under this section to an eligible trauma center may be used to train and
p.001211: incorporate military trauma care providers into such trauma center, in- cluding incorporation into
p.001211: operational exercises and training drills related to public health emergencies, expenditures for malpractice
p.001211: insurance, office space, information technology, specialty education and supervision, trauma
p.001211: programs, re- search, and applicable license fees for such military trauma care providers.
p.001211: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect any other provision of
p.001211: law that preempts State licensing requirements for health care professionals, including with respect to military
p.001211: trauma care providers.
p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
p.001211: and the Secretary of De- fense a report for such year that includes information on—
p.001211: (A) the number and types of trauma cases managed by military trauma teams or military trauma care providers
p.001211: pursuant to such grant during such year;
p.001211: (B) the ability to maintain the integration of the mili- tary trauma providers or teams of providers as part of the
p.001211: trauma center, including the financial effect of such grant on the trauma center;
p.001211: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001213: PUBLIC HEALTH SERVICE ACT
p.001213: Sec. 1291
p.001213:
p.001213: (C) the educational effect on resident trainees in cen- ters where military trauma teams are assigned;
p.001213: (D) any research conducted during such year sup- ported by such grant; and
p.001213: (E) any other information required by the Secretaries for the purpose of evaluating the effect of such grant.
p.001213: (2) REPORT TO CONGRESS.—Not less than once every 2 years, the Secretary, in consultation with the Secretary of
p.001213: De- fense, shall submit a report to the congressional committees of jurisdiction that includes information on the
p.001213: effect of placing military trauma care providers in trauma centers awarded grants under this section on—
p.001213: (A) maintaining military trauma care providers’ readi- ness and ability to respond to and treat battlefield injuries;
p.001213: (B) providing health care to civilian trauma patients in urban and rural settings;
p.001213: (C) the capability of trauma centers and military trau- ma care providers to increase medical surge capacity,
p.001213: in- cluding as a result of a large-scale event;
p.001213: (D) the ability of grant recipients to maintain the inte- gration of the military trauma providers or teams of
p.001213: pro- viders as part of the trauma center;
p.001213: (E) efforts to incorporate military trauma care pro- viders into operational exercises and training and drills
p.001213: for public health emergencies; and
p.001213: (F) the capability of military trauma care providers to participate as part of a medical response during or in
p.001213: ad- vance of a public health emergency, as determined by the Secretary, or a mass casualty incident.
p.001213: (f) DEFINITIONS.—For purposes of this part:
p.001213: (1) ELIGIBLE HIGH-ACUITY TRAUMA CENTER.—The term ‘‘eli- gible high-acuity trauma center’’ means a Level I trauma
p.001213: cen- ter that satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams
p.001213: to provide trauma care and related acute care at such trauma center.
p.001213: (B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which
p.001213: data are available are treated for a major trauma at such trauma center.
p.001213: (C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (D) Such trauma center is an academic training cen- ter—
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p.001213: (i) affiliated with a medical school;
p.001213: (ii) that maintains residency programs and fellow- ships in critical trauma specialties and subspecialties, and
p.001213: provides education and supervision of military trauma team members according to those specialties and
p.001213: subspecialties; and
p.001213: (iii) that undertakes research in the prevention and treatment of traumatic injury.
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001213:
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p.001213: Sec. 1301 PUBLIC HEALTH SERVICE ACT 1214
p.001213:
p.001213: (E) Such trauma center serves as a medical and public health preparedness and response leader for its commu-
p.001213: nity, such as by participating in a partnership for State and regional hospital preparedness established
p.001213: under sec- tion 319C–2 or 319C–3.
p.001213: (2) ELIGIBLE TRAUMA CENTER.—The term ‘‘eligible trauma center’’ means a Level I, II, or III trauma center that
p.001213: satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma care
p.001213: pro- viders to provide trauma care and related acute care at such trauma center.
p.001213: (B) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (C) Such trauma center demonstrates a need for inte- grated military trauma care providers to maintain
p.001213: or im- prove the trauma clinical capability of such trauma center.
p.001213: (3) MAJOR TRAUMA.—The term ‘‘major trauma’’ means an injury that is greater than or equal to 15 on the injury
p.001213: severity score.
p.001213: (4) MILITARY TRAUMA TEAM.—The term ‘‘military trauma team’’ means a complete military trauma team
p.001213: consisting of military trauma care providers.
p.001213: (5) MILITARY TRAUMA CARE PROVIDER.—The term ‘‘military trauma care provider’’ means a member of the Armed
p.001213: Forces who furnishes emergency, critical care, and other trauma acute care services (including a physician, surgeon,
p.001213: physician assist- ant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic,
p.001213: or enlisted medical technician) or other military trauma care provider as the Secretary deter- mines
p.001213: appropriate.
p.001213: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated $11,500,000
p.001213: for each of fiscal years 2019 through 2023.
p.001213: TITLE XIII—HEALTH MAINTENANCE ORGANIZATIONS
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p.001213: January 30, 2020
p.001213:
p.001213: REQUIREMENTS FOR HEALTH MAINTENANCE ORGANIZATIONS
p.001213: SEC. 1301. ø300e¿ (a) For purposes of this title, the term ‘‘health maintenance organization’’ means a public
p.001213: or private entity which is organized under the laws of any State and which (1) pro- vides basic and supplemental health
p.001213: services to its members in the manner prescribed by subsection (b), and (2) is organized and oper- ated in the manner
p.001213: prescribed by subsection (c).
p.001213: (b) A health maintenance organization shall provide, without limitations as to time or cost other than
p.001213: those prescribed by or under this title, basic and supplemental health services to its mem- bers in the following
p.001213: manner:
p.001213: (1) Each member is to be provided basic health services for a basic health services payment which (A) is to be
p.001213: paid on a periodic basis without regard to the dates health services (within the basic health
p.001213: services) are provided; (B) is fixed without regard to the frequency, extent, or kind of health serv-
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001213:
p.001213:
p.001213:
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p.001643: January 30, 2020
p.001643: the date of the injury multiplied by 40, for purposes of computing benefits under section 8118 of such title.
p.001643: (3) EMPLOYMENT AND REEMPLOYMENT RIGHTS.—
p.001643: (A) IN GENERAL.—Service as an intermittent disaster- response appointee when the Secretary activates the
p.001643: Na- tional Disaster Medical System or when the individual participates in a training program authorized by
p.001643: the As- sistant Secretary for Preparedness and Response or a com- parable official of any Federal agency
p.001643: specified in sub- section (a)(2)(B) shall be deemed ‘‘service in the uniformed services’’ for purposes of chapter
p.001643: 43 of title 38, United States Code, pertaining to employment and reemployment rights of individuals who have
p.001643: performed service in the uniformed services (regardless of whether the individual receives compensation for
p.001643: such participation). All rights and obligations of such persons and procedures for assist- ance,
p.001643: enforcement, and investigation shall be as provided for in chapter 43 of title 38, United States Code.
p.001643: (B) NOTICE OF ABSENCE FROM POSITION OF EMPLOY-
p.001643: MENT.—Preclusion of giving notice of service by necessity of Service as an intermittent disaster-response
p.001643: appointee when the Secretary activates the National Disaster Med- ical System shall be deemed preclusion by
p.001643: ‘‘military neces- sity’’ for purposes of section 4312(b) of title 38, United States Code, pertaining to
p.001643: giving notice of absence from a position of employment. A determination of such necessity shall be made by the
p.001643: Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review.
p.001643: (4) LIMITATION.—An intermittent disaster-response ap- pointee shall not be deemed an employee of the Department
p.001643: of Health and Human Services for purposes other than those spe- cifically set forth in this section.
p.001643: (e) RULE OF CONSTRUCTION REGARDING USE OF COMMISSIONED CORPS.—If the Secretary assigns commissioned officers of
p.001643: the Reg- ular or Reserve Corps to serve with the National Disaster Medical System, such assignments do not affect
p.001643: the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps,
p.001643: respectively (including with respect to pay and al- lowances, retirement, benefits, rights, privileges, and
p.001643: immunities).
p.001643: (f) DEFINITION.—For purposes of this section, the term ‘‘auxil- iary services’’ includes mortuary services,
p.001643: veterinary services, and other services that are determined by the Secretary to be appro- priate with
p.001643: respect to the needs referred to in subsection (a)(3)(A).
p.001643: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing for the Assistant Secretary for
p.001643: Preparedness and Re- sponse and the operations of the National Disaster Medical Sys- tem, other than
p.001643: purposes for which amounts in the Public Health Emergency Fund under section 319 are available, there are
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p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017:
p.000017: tivities of the Track in education, research, and techno- logical applications of knowledge; and
p.000017: (E) to accept the voluntary services of guest scholars and other persons.
p.000017: (2) LIMITATION.—The Surgeon General may not enter into any contract with an entity if the contract would
p.000017: obligate the Track to make outlays in advance of the enactment of budget authority for such outlays.
p.000017: (3) SCIENTISTS.—Scientists or other medical, dental, or nursing personnel utilized by the Track under
p.000017: an agreement described in paragraph (1) may be appointed to any position within the Track and may be
p.000017: permitted to perform such duties within the Track as the Surgeon General may approve.
p.000017: (4) VOLUNTEER SERVICES.—A person who provides vol- untary services under the authority of
p.000017: subparagraph (E) of paragraph (1) shall be considered to be an employee of the Fed- eral Government for the purposes
p.000017: of chapter 81 of title 5, relat- ing to compensation for work-related injuries, and to be an em- ployee of the
p.000017: Federal Government for the purposes of chapter 171 of title 28, relating to tort claims. Such a person
p.000017: who is not otherwise employed by the Federal Government shall not be considered to be a Federal employee
p.000017: for any other purpose by reason of the provision of such services.
p.000017: SEC. 273. ø239l–2¿ STUDENTS; SELECTION; OBLIGATION.
p.000017: (a) STUDENT SELECTION.—
p.000017: (1) IN GENERAL.—Medical, dental, physician assistant, pharmacy, behavioral and mental health, public
p.000017: health, and nursing students at the Track shall be selected under proce- dures prescribed by the Surgeon
p.000017: General. In so prescribing, the Surgeon General shall consider the recommendations of the National Health Care
p.000017: Workforce Commission.
p.000017: (2) PRIORITY.—In developing admissions procedures under paragraph (1), the Surgeon General shall ensure that such
p.000017: pro- cedures give priority to applicant medical, dental, physician as- sistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students from rural communities and underrepresented minorities.
p.000017: (b) CONTRACT AND SERVICE OBLIGATION.—
p.000017: (1) CONTRACT.—Upon being admitted to the Track, a med- ical, dental, physician assistant, pharmacy,
p.000017: behavioral and mental health, public health, or nursing student shall enter into a written contract with
p.000017: the Surgeon General that shall contain—
p.000017: (A) an agreement under which—
p.000017: (i) subject to subparagraph (B), the Surgeon Gen- eral agrees to provide the student with tuition (or tui- tion
p.000017: remission) and a student stipend (described in paragraph (2)) in each school year for a period of years (not to
p.000017: exceed 4 school years) determined by the stu- dent, during which period the student is enrolled in the
p.000017: Track at an affiliated or other participating health professions institution pursuant to an agreement be- tween
p.000017: the Track and such institution; and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 71 PUBLIC HEALTH SERVICE ACT Sec. 273
p.000017:
p.000017: (ii) subject to subparagraph (B), the student agrees—
p.000017: (I) to accept the provision of such tuition and student stipend to the student;
p.000017: (II) to maintain enrollment at the Track until the student completes the course of study in- volved;
p.000017: (III) while enrolled in such course of study, to maintain an acceptable level of academic standing (as determined by
p.000017: the Surgeon General);
p.000017: (IV) if pursuing a degree from a school of medicine or osteopathic medicine, dental, public health, or
p.000017: nursing school or a physician assistant, pharmacy, or behavioral and mental health pro- fessional program, to
p.000017: complete a residency or in- ternship in a specialty that the Surgeon General determines is appropriate; and
p.000017: (V) to serve for a period of time (referred to in this part as the ‘‘period of obligated service’’) with- in the
p.000017: Commissioned Corps of the Public Health Service equal to 2 years for each school year dur- ing which such
p.000017: individual was enrolled at the Col- lege, reduced as provided for in paragraph (3);
p.000017: (B) a provision that any financial obligation of the United States arising out of a contract entered into under
p.000017: this part and any obligation of the student which is condi- tioned thereon, is contingent upon funds being
p.000017: appro- priated to carry out this part;
p.000017: (C) a statement of the damages to which the United States is entitled for the student’s breach of the
p.000017: contract; and
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p.000017: January 30, 2020
p.000017: (D) such other statements of the rights and liabilities of the Secretary and of the individual, not
p.000017: inconsistent with the provisions of this part.
p.000017: (2) TUITION AND STUDENT STIPEND.—
p.000017: (A) TUITION REMISSION RATES.—The Surgeon General, based on the recommendations of the National Health Care
p.000017: Workforce Commission, shall establish Federal tui- tion remission rates to be used by the Track to provide re-
p.000017: imbursement to affiliated and other participating health professions institutions for the cost of educational
p.000017: services provided by such institutions to Track students. The agree- ment entered into by such participating
p.000017: institutions under paragraph (1)(A)(i) shall contain an agreement to accept as payment in full the established
p.000017: remission rate under this subparagraph.
p.000017: (B) STIPEND.—The Surgeon General, based on the rec- ommendations of the National Health Care Workforce
p.000017: Commission, shall establish and update Federal stipend rates for payment to students under this part.
p.000017: (3) REDUCTIONS IN THE PERIOD OF OBLIGATED SERVICE.— The period of obligated service under paragraph
p.000017: (1)(A)(ii)(V) shall be reduced—
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 274 PUBLIC HEALTH SERVICE ACT 72
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p.000017: January 30, 2020
p.000017:
p.000017: (A) in the case of a student who elects to participate in a high-needs speciality residency (as determined by
p.000017: the National Health Care Workforce Commission), by 3 months for each year of such participation (not
p.000017: to exceed a total of 12 months); and
p.000017: (B) in the case of a student who, upon completion of their residency, elects to practice in a Federal
p.000017: medical fa- cility (as defined in section 781(e)) that is located in a health professional shortage area
p.000017: (as defined in section 332), by 3 months for year of full-time practice in such a facility (not to exceed
p.000017: a total of 12 months).
p.000017: (c) SECOND 2 YEARS OF SERVICE.—During the third and fourth years in which a medical, dental, physician
p.000017: assistant, pharmacy, behavioral and mental health, public health, or nursing student is enrolled in the Track,
p.000017: training should be designed to prioritize clin- ical rotations in Federal medical facilities in health
p.000017: professional shortage areas, and emphasize a balance of hospital and commu- nity-based experiences, and
p.000017: training within interdisciplinary teams.
p.000017: (d) DENTIST, PHYSICIAN ASSISTANT, PHARMACIST, BEHAVIORAL AND MENTAL HEALTH PROFESSIONAL, PUBLIC
p.000017: HEALTH PROFES- SIONAL, AND NURSE TRAINING.—The Surgeon General shall estab- lish provisions applicable
p.000017: with respect to dental, physician assist- ant, pharmacy, behavioral and mental health, public health, and
p.000017: nursing students that are comparable to those for medical students under this section, including service
p.000017: obligations, tuition support, and stipend support. The Surgeon General shall give priority to health
p.000017: professions training institutions that train medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, pub- lic health, and nursing students for some significant period of time together, but at a minimum
p.000017: have a discrete and shared core cur- riculum.
p.000017: (e) ELITE FEDERAL DISASTER TEAMS.—The Surgeon General, in consultation with the Secretary, the Director of the Centers
p.000017: for Dis- ease Control and Prevention, and other appropriate military and Federal government agencies, shall
p.000017: develop criteria for the appoint- ment of highly qualified Track faculty, medical, dental, physician assistant,
p.000017: pharmacy, behavioral and mental health, public health, and nursing students, and graduates to elite
p.000017: Federal disaster pre- paredness teams to train and to respond to public health emer- gencies, natural
p.000017: disasters, bioterrorism events, and other emer- gencies.
p.000017: (f) STUDENT DROPPED FROM TRACK IN AFFILIATE SCHOOL.—A medical, dental, physician assistant, pharmacy,
p.000017: behavioral and mental health, public health, or nursing student who, under regu- lations prescribed by
p.000017: the Surgeon General, is dropped from the Track in an affiliated school for deficiency in conduct or studies, or
p.000017: for other reasons, shall be liable to the United States for all tuition and stipend support provided to the student.
p.000017: SEC. 274. ø239l–3¿ FUNDING.
p.000017: Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services
p.000017: Emergency Fund such sums as may be necessary to carry out this part.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017: 73 PUBLIC HEALTH SERVICE ACT Sec. 301
p.000017:
p.000017: TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
p.000017: PART A—RESEARCH AND INVESTIGATION
p.000017: IN GENERAL
p.000017: SEC. 301. ø241¿ (a) The Secretary shall conduct in the Service, and encourage, cooperate with, and render
p.000017: assistance to other ap- propriate public authorities, scientific institutions, and scientists in the conduct of,
p.000017: and promote the coordination of, research, inves- tigations, experiments, demonstrations, and studies relating to
p.000017: the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of
p.000017: man, including water pu- rification, sewage treatment, and pollution of lakes and streams. In carrying out the
p.000017: foregoing the Secretary is authorized to—
p.000017: (1) collect and make available through publications and other appropriate means, information as to, and
p.000017: the practical application of, such research and other activities;
p.000017: (2) make available research facilities of the Service to ap- propriate public authorities, and to health
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p.000133: January 30, 2020
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p.000133: terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development
p.000133: of school-based dental sealant programs to improve the access of children to sealants.
p.000133: (2) USE OF FUNDS.—A State shall use amounts received under a grant under paragraph (1) to provide funds to
p.000133: eligible school-based entities or to public elementary or secondary schools to enable such entities
p.000133: or schools to provide children with access to dental care and dental sealant services. Such services
p.000133: shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws.
p.000133: (3) ELIGIBILITY.—To be eligible to receive funds under paragraph (1), an entity shall—
p.000133: (A) prepare and submit to the State an application at such time, in such manner and containing such informa-
p.000133: tion as the State may require; and
p.000133: (B) be a public elementary or secondary school—
p.000133: (i) that is located in an urban area in which and more than 50 percent of the student population is par-
p.000133: ticipating in Federal or State free or reduced meal pro- grams; or
p.000133: (ii) that is located in a rural area and, with re- spect to the school district in which the school
p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
p.000133: interpretation, (including determinants of poor oral health among vulnerable populations), a
p.000133: multi-dimensional delivery system for oral health, and to implement science-based programs (including
p.000133: dental sealants and community water fluoridation) to improve oral health.
p.000133: (2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
p.000133: ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through
p.000133: 2014.
p.000133: (e) DEFINITIONS.—For purposes of this section, the term ‘‘In- dian tribe’’ means an Indian tribe or tribal
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p.000321: as may be necessary for each of the fiscal years 2008 through 2012.
p.000321: (b) An appropriation under an authorization under subsection
p.000321: (a) for any fiscal year may be made at any time before that fiscal year and may be included in an Act
p.000321: making an appropriation under an authorization under subsection (a) for another fiscal year; but no funds
p.000321: may be made available from any appropriation under such authorization for obligation under sections 331
p.000321: through 335, section 336A, and section 337 before the fiscal year for which such appropriation is authorized.
p.000321:
p.000321: Subpart III—Scholarship Program and Loan Repayment Program
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p.000321: January 30, 2020
p.000321: NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP PROGRAM
p.000321: SEC. 338A. ø254l¿ (a) The Secretary shall establish the Na- tional Health Service Corps Scholarship
p.000321: Program to assure, with respect to the provision of primary health services pursuant to sec- tion 331(a)(2)—
p.000321: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000321: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000321: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000321: (b) To be eligible to participate in the Scholarship Program, an individual must—
p.000321: (1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by
p.000321: the Secretary) educational institution in a State and (B) in a course of study or program, offered by
p.000321: such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medi- cine,
p.000321: dentistry, or other health profession, or an appropriate degree from a graduate program of behavioral and
p.000321: mental health;
p.000321: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000321: Corps of the Service or be eligible for selection for civilian service in the Corps;
p.000321: (3) submit an application to participate in the Scholarship Program; and
p.000321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000323: PUBLIC HEALTH SERVICE ACT
p.000323: Sec. 338A
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p.000325: determined under regulations of the Secretary by the educational institution offering such course of
p.000325: study);
p.000325: (iv) if pursuing a degree from a school of medicine or osteopathic medicine, to complete a residency in a
p.000325: specialty that the Secretary determines is consistent with the needs of the Corps; and
p.000325: (v) to serve for a time period (hereinafter in the subpart referred to as the ‘‘period of obligated service’’)
p.000325: equal to—
p.000325: (I) one year for each school year for which the individual was provided a scholarship under the Scholarship
p.000325: Program, or
p.000325: (II) two years,
p.000325: whichever is greater, as a provider of primary health services in a health professional shortage area
p.000325: (des- ignated under section 332) to which he is assigned by the Secretary as a member of the Corps, or as
p.000325: other- wise provided in this subpart;
p.000325: (2) a provision that any financial obligation of the United States arising out of a contract entered into
p.000325: under this subpart and any obligation of the individual which is conditioned there- on, is contingent upon funds
p.000325: being appropriated for scholar- ships under this subpart and to carry out the purposes of sec- tions 331 through 335
p.000325: and sections 337 and 338;
p.000325: (3) a statement of the damages to which the United States is entitled, under section 338E for the individual’s
p.000325: breach of the contract; and
p.000325: (4) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with
p.000325: the pro- visions of this subpart.
p.000325: (g)(1) A scholarship provided to a student for a school year under a written contract under the Scholarship
p.000325: Program shall con- sist of—
p.000325:
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p.000325: January 30, 2020
p.000325: (A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the amount (except as
p.000325: provided in sec- tion 711) of—
p.000325: (i) the tuition of the student in such school year; and
p.000325: (ii) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred
p.000325: by the student in such school year; and
p.000325: (B) payment to the student of a stipend of $400 per month (adjusted in accordance with paragraph (3)) for each of the
p.000325: 12 consecutive months beginning with the first month of such school year.
p.000325: (2) The Secretary may contract with an educational institution, in which a participant in the Scholarship
p.000325: Program is enrolled, for the payment to the educational institution of the amounts of tui-
p.000325: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000325: Sec. 338B PUBLIC HEALTH SERVICE ACT 326
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p.000325: tion and other reasonable educational expenses described in para- graph (1)(A). Payment to such an
...

p.000325: Code) of the adjustment (if such adjustment is an increase) in the rates of pay under the Gen- eral Schedule made
p.000325: effective in the fiscal year in which such school year ends.
p.000325: (h) Notwithstanding any other provision of law, individuals who have entered into written contracts with
p.000325: the Secretary under this section, while undergoing academic training, shall not be counted against
p.000325: any employment ceiling affecting the Department.
p.000325: SEC. 338B. ø254l–1¿ NATIONAL HEALTH SERVICE CORPS LOAN REPAY- MENT PROGRAM.
p.000325: (a) ESTABLISHMENT.—The Secretary shall establish a program to be known as the National Health Service Corps
p.000325: Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to section
p.000325: 331(a)(2)—
p.000325: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000325: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000325: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000325: (b) ELIGIBILITY.—To be eligible to participate in the Loan Re- payment Program, an individual must—
p.000325: (1)(A) have a degree in medicine, osteopathic medicine, dentistry, or another health profession, or an
p.000325: appropriate de- gree from a graduate program of behavioral and mental health, or be certified as a nurse midwife,
p.000325: nurse practitioner, or physi- cian assistant;
p.000325: (B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry,
p.000325: behavioral and mental health, or other health profession; or
p.000325: (C) be enrolled as a full-time student—
p.000325: (i) in an accredited (as determined by the Secretary) educational institution in a State; and
p.000325: (ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary,
p.000325: leading to a degree in medicine, osteopathic medicine, den- tistry, or other health profession;
p.000325: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000325: Corps of the Service or be eligible for selection for civilian service in the Corps; and
p.000325: (3) submit to the Secretary an application for a contract described in subsection (f) (relating to the payment
p.000325: by the Sec- retary of the educational loans of the individual in consider- ation of the individual serving for
p.000325: a period of obligated service).
p.000325: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000327: PUBLIC HEALTH SERVICE ACT
p.000327: Sec. 338B
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p.000525: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000525: (D) local public and private elementary or secondary schools; or
p.000525: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000525: U.S.C. 1437a).
p.000525: (c) EVALUATION.—An eligible entity that receives a grant under this section shall submit to the Secretary an evaluation
p.000525: of the oper- ations and activities carried out under the grant that includes—
p.000525: (1) a description of the health status outcomes of children assisted under the grant;
p.000525: (2) an assessment of the utilization of asthma-related health care services as a result of
p.000525: activities carried out under the grant;
p.000525: (3) the collection, analysis, and reporting of asthma data according to guidelines prescribed by the
p.000525: Director of the Cen- ters for Disease Control and Prevention; and
p.000525: (4) such other information as the Secretary may require.
p.000525: (d) PREFERENCE FOR STATES THAT ALLOW STUDENTS TO SELF- ADMINISTER MEDICATION TO TREAT ASTHMA AND
p.000525: ANAPHYLAXIS.—
p.000104: 104
p.000104: (1) PREFERENCE.—The Secretary, in making any grant under this section or any other grant that is
p.000104: asthma-related (as determined by the Secretary) to a State, shall give pref- erence to any State that
p.000104: satisfies the following:
p.000104: (A) IN GENERAL.—The State must require that each public elementary school and secondary school in that
p.000104: State will grant to any student in the school an authoriza- tion for the self-administration of medication to treat
p.000104: that student’s asthma or anaphylaxis, if—
p.000104: (i) a health care practitioner prescribed the medi- cation for use by the student during school hours and
p.000104: instructed the student in the correct and responsible use of the medication;
p.000104: (ii) the student has demonstrated to the health care practitioner (or such practitioner’s designee) and
p.000104: the school nurse (if available) the skill level necessary to use the medication and any device that is necessary to
p.000104: administer such medication as prescribed;
p.000104:
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p.000104: January 30, 2020
p.000104: 104 Subsection (d) was added by section 3(a) of Public Law 108–377 (118 Stat. 2203), which was enacted
p.000104: October 30, 2004. Section 3(b) of such Public Law provides as follows: ‘‘The amend- ments made by this section
p.000104: shall apply only with respect to grants made on or after the date that is 9 months after the date of the
p.000104: enactment of this Act.’’.
p.000104: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000527: PUBLIC HEALTH SERVICE ACT
p.000527: Sec. 399L
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p.000527: January 30, 2020
p.000527: (iii) the health care practitioner formulates a writ- ten treatment plan for managing asthma or anaphy- laxis
p.000527: episodes of the student and for medication use by the student during school hours; and
p.000527: (iv) the student’s parent or guardian has com- pleted and submitted to the school any written docu-
p.000527: mentation required by the school, including the treat- ment plan formulated under clause (iii) and other doc-
p.000527: uments related to liability.
p.000527: (B) SCOPE.—An authorization granted under subpara- graph (A) must allow the student involved to possess
p.000527: and use his or her medication—
p.000527: (i) while in school;
p.000527: (ii) while at a school-sponsored activity, such as a sporting event; and
p.000527: (iii) in transit to or from school or school-spon- sored activities.
p.000527: (C) DURATION OF AUTHORIZATION.—An authorization granted under subparagraph (A)—
p.000527: (i) must be effective only for the same school and school year for which it is granted; and
p.000527: (ii) must be renewed by the parent or guardian each subsequent school year in accordance with this
p.000527: subsection.
p.000527: (D) BACKUP MEDICATION.—The State must require that backup medication, if provided by a student’s
p.000527: parent or guardian, be kept at a student’s school in a location to which the student has immediate access in
p.000527: the event of an asthma or anaphylaxis emergency.
p.000527: (E) MAINTENANCE OF INFORMATION.—The State must require that information described in subparagraphs
p.000527: (A)(iii) and (A)(iv) be kept on file at the student’s school in a location easily accessible in the event of an
p.000527: asthma or anaphylaxis emergency.
p.000527: (F) SCHOOL PERSONNEL ADMINISTRATION OF EPINEPH- RINE.—In determining the preference (if any) to be
p.000527: given to a State under this subsection, the Secretary shall give additional preference to a State that
p.000527: provides to the Sec- retary the certification described in subparagraph (G) and that requires that each public
p.000527: elementary school and sec- ondary school in the State—
p.000527: (i) permits trained personnel of the school to ad- minister epinephrine to any student of the school rea-
p.000527: sonably believed to be having an anaphylactic reac- tion;
p.000527: (ii) maintains a supply of epinephrine in a secure location that is easily accessible to trained personnel of
p.000527: the school for the purpose of administration to any student of the school reasonably believed to be having an
p.000527: anaphylactic reaction; and
p.000527: (iii) has in place a plan for having on the premises of the school during all operating hours of the school
p.000527: one or more individuals who are trained personnel of the school.
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000527: Sec. 399M PUBLIC HEALTH SERVICE ACT 528
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p.000527: January 30, 2020
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p.000527: (G) CIVIL LIABILITY PROTECTION LAW.—The certifi- cation required in subparagraph (F) shall be a
p.000527: certification made by the State attorney general that the State has re- viewed any applicable civil liability
p.000527: protection law to deter- mine the application of such law with regard to elemen- tary and secondary school
p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
p.000527: INFANTS, AND YOUNG CHILDREN.
p.000527: (a) STATEWIDE NEWBORN, INFANT, AND YOUNG CHILD HEARING SCREENING, EVALUATION AND INTERVENTION PROGRAMS AND
p.000527: SYS-
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: provision to children and adolescents;
p.000573: (ii) the SBHC has made and will continue to make every reasonable effort to establish and maintain col-
p.000573: laborative relationships with other health care pro- viders in the catchment area of the SBHC;
p.000573: (iii) the SBHC will provide on-site access during the academic day when school is in session and 24-
p.000573: hour coverage through an on-call system and through its backup health providers to ensure access to
p.000573: serv- ices on a year-round basis when the school or the SBHC is closed;
p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
p.000573: school personnel, such as administrators, teachers, nurses, counselors, and support personnel, as well
p.000573: as with other community providers co-located at the school;
p.000573: (v) the SBHC sponsoring facility assumes all re- sponsibility for the SBHC administration, operations, and
p.000573: oversight; and
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
p.000573:
p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
p.000573: (A) Communities that have evidenced barriers to pri- mary health care and mental health and substance
p.000573: use disorder prevention services for children and adolescents.
p.000573: (B) Communities with high per capita numbers of chil- dren and adolescents who are uninsured, underinsured, or enrolled
p.000573: in public health insurance programs.
p.000573: (C) Populations of children and adolescents that have historically demonstrated difficulty in accessing health
p.000573: and mental health and substance use disorder prevention serv- ices.
p.000573: (2) The Secretary may give consideration to whether an applicant has received a grant under subsection
p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
...

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p.000635:
p.000637: 637
p.000637: PUBLIC HEALTH SERVICE ACT
p.000637: Sec. 403D
p.000637:
p.000637: (2) CONTENTS.—For each whistleblower complaint pending during the year for which a report is submitted under this sub-
p.000637: section, the report shall identify the following:
p.000637: (A) Each agency of the National Institutes of Health involved.
p.000637: (B) The status of the complaint.
p.000637: (C) The resolution of the complaint to date.
p.000637: (b) FIRST REPORT.—The first report under subsection (a) shall be submitted not later than 1 year after the date
p.000637: of the enactment of the National Institutes of Health Reform Act of 2006.
p.000637: SEC. 403C. ø283a–2¿ ANNUAL REPORTING REGARDING TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES.
p.000637: (a) IN GENERAL.—Each institution receiving an award under this title for the training of graduate students for
p.000637: doctoral degrees shall annually report to the Director of NIH, with respect to grad- uate students supported by the
p.000637: National Institutes of Health at such institution—
p.000637: (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
p.000637: (2) for students described in paragraph (1), the average time between the beginning of graduate study
p.000637: and the receipt of a doctoral degree.
p.000637: (3) 5 PROVISION OF INFORMATION TO APPLICANTS.—Each in- stitution described in subsection (a) shall provide
p.000637: to each stu- dent submitting an application for a program of graduate study at such institution the information
p.000637: described in paragraphs (1) and (2) of such subsection with respect to the program or pro- grams to which such student
p.000637: has applied.
p.000637: DES
p.000637: SEC. 403D. ø283a–3¿ (a) The Director of NIH shall establish a program for the conduct and support of research and
p.000637: training, the dissemination of health information, and other programs with re- spect to the diagnosis and
p.000637: treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred
p.000637: to as ‘‘DES’’).
p.000637: (b) In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private
p.000637: entities representing individ- uals who have been exposed to DES, shall conduct or support pro- grams to educate
p.000637: health professionals and the public on the drug, including the importance of identifying and treating
p.000637: individuals who have been exposed to the drug.
p.000637: (c) After consultation with the Office of Research on Women’s Health, the Director of NIH, acting
p.000637: through the appropriate na- tional research institutes, shall in carrying out subsection (a) con- duct or
p.000637: support one or more longitudinal studies to determine the incidence of the following diseases or
p.000637: disorders in the indicated populations and the relationship of DES to the diseases or dis- orders:
p.000637: (1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant,
p.000637:
p.000637:
p.000637:
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p.000827: 827
p.000827: PUBLIC HEALTH SERVICE ACT
p.000827: Sec. 501
p.000827:
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p.000827: January 30, 2020
p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
...

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p.000869: Sec. 519B PUBLIC HEALTH SERVICE ACT 870
p.000869:
p.000869: (I) reach out to students and community stakeholders;
p.000869: (II) promote the purpose of this paragraph;
p.000869: (III) address the range of needs of the stu- dents and the surrounding communities; and
p.000869: (IV) address community norms for underage students regarding alcohol use; and
p.000869: (viii) such additional information as required by the Secretary.
p.000869: (C) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000869: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph (B).
p.000869: (D) ACCOUNTABILITY.—On the date on which the Sec- retary first publishes a notice in the Federal Register solic-
p.000869: iting applications for grants under this paragraph, the Sec- retary shall include in the notice achievement
p.000869: indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
p.000869: (i) to measure the impact that the statewide coali- tions assisted under this paragraph are having on the institutions
p.000869: of higher education and the surrounding communities, including changes in the number of inci- dents of any kind in
p.000869: which students have abused alco- hol or consumed alcohol while under the age of 21 (in- cluding violations, physical
p.000869: assaults, sexual assaults, reports of intimidation, disruptions of school functions, disruptions of student studies,
p.000869: mental health referrals, illnesses, or deaths);
p.000869: (ii) to measure the quality and accessibility of the programs or information offered by the eligible entity; and
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p.000869: January 30, 2020
p.000869: (iii) to provide such other measures of program impact as the Secretary determines appropriate.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: and not supplant, Federal and non-Federal funds available for carrying out the activities described in this paragraph.
p.000869: (F) DEFINITIONS.—For purposes of this paragraph:
p.000869: (i) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, institution of higher education, or non- profit
p.000869: entity.
p.000869: (ii) INSTITUTION OF HIGHER EDUCATION.—The term ‘‘institution of higher education’’ has the meaning given
p.000869: the term in section 101(a) of the Higher Edu- cation Act of 1965 (20 U.S.C. 1001(a)).
p.000869: (iii) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Education.
p.000869: (iv) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Common- wealth of
p.000869: Puerto Rico.
p.000869: (v) STATEWIDE COALITION.—The term ‘‘statewide coalition’’ means a coalition that—
p.000869: (I) includes, but is not limited to—
...

p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
p.000881: object based on the parents’ or legal guardians’ religious beliefs or moral objections.
p.000881: (g) EVALUATIONS AND REPORT.—
p.000881: (1) EVALUATIONS BY ELIGIBLE ENTITIES.—Not later than 18 months after receiving a grant or cooperative agreement
p.000881: under this section, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted
p.000881: by the entity con- cerning the effectiveness of the activities carried out under the grant or agreement.
p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
p.000881:
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p.000881: January 30, 2020
p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: 883
p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
...

p.000885: disorders.
p.000885: (2) The operation of hotlines.
p.000885: (3) Preparing informational material.
p.000885: (4) Providing outreach services to notify students about available mental and substance use disorder services.
p.000885: (5) Administering voluntary mental and substance use dis- order screenings and assessments.
p.000885: (6) Supporting the training of students, faculty, and staff to respond effectively to students with
p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000885:
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p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
...

p.000887: (e) REQUIREMENT OF MATCHING FUNDS.—
p.000887: (1) IN GENERAL.—The Secretary may make a grant under this section to an institution of higher education only if
p.000887: the in- stitution agrees to make available (directly or through dona- tions from public or private entities)
p.000887: non-Federal contributions
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: Sec. 520E–3 PUBLIC HEALTH SERVICE ACT 888
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p.000887: January 30, 2020
p.000887:
p.000887: in an amount that is not less than $1 for each $1 of Federal funds provided in the grant, toward the costs
p.000887: of activities car- ried out with the grant (as described in subsection (b)) and other activities by the
p.000887: institution to reduce student mental health and substance use disorders.
p.000887: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required under paragraph (1) may be in cash
p.000887: or in kind. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
p.000887: extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.000887: contributions.
p.000887: (3) WAIVER.—The Secretary may waive the requirement established in paragraph (1) with respect to an
p.000887: institution of higher education if the Secretary determines that extraor- dinary need at the institution
p.000887: justifies the waiver.
p.000887: (f) REPORTS.—For each fiscal year that grants are awarded under this section, the Secretary shall conduct
p.000887: a study on the re- sults of the grants and submit to the Congress a report on such re- sults that includes the
p.000887: following:
p.000887: (1) An evaluation of the grant program outcomes, includ- ing a summary of activities carried out with the grant
p.000887: and the results achieved through those activities.
p.000887: (2) Recommendations on how to improve access to mental health and substance use disorder services at
p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
...

p.000975: remodeling, replacement, and renovation of existing buildings (including initial equipment thereof), and
p.000975: replacement of obsolete, built-in (as determined in ac- cordance with regulations) equipment of existing buildings.
p.000975: (l) The term ‘‘title,’’ when used with reference to a site for a project, means a fee simple, or such other
p.000975: estate or interest (includ- ing a leasehold on which the rental does not exceed 4 per centum of the value
p.000975: of the land) as the Surgeon General finds sufficient to assure for a period of not less than fifty years’ undisturbed
p.000975: use and possession for the purposes of construction and operation of the project.
p.000975:
p.000975: FINANCIAL STATEMENTS
p.000975: SEC. 646. ø291o–1¿ In the case of any facility for which a grant, loan, or loan guarantee has been made
p.000975: under this title, the applicant for such grant, loan, or loan guarantee (or, if appropriate, such other person as the
p.000975: Secretary may prescribe) shall file at least annually with the State agency for the State in which the
p.000975: facility is located a statement which shall be in such form, and contain such information, as the
p.000975: Secretary may require to accurately show—
p.000975: (1) the financial operations of the facility, and
p.000975: (2) the costs to the facility of providing health services in the facility and the charges made by the
p.000975: facility for providing such services,
p.000975: during the period with respect to which the statement is filed.
p.000975:
p.000975: TITLE VII—HEALTH PROFESSIONS EDUCATION
p.000975: PART A—STUDENT LOANS
p.000975: Subpart I—Insured Health Education Assistance Loans to Graduate Students
p.000975:
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p.000975: January 30, 2020
p.000975: SEC. 701. ø292¿ STATEMENT OF PURPOSE.
p.000975: The purpose of this subpart is to enable the Secretary to pro- vide a Federal program of student loan
p.000975: insurance for students in (and certain former students of) eligible institutions (as defined in section
p.000975: 719).
p.000975: SEC. 702. ø292a¿ SCOPE AND DURATION OF LOAN INSURANCE PRO- GRAM.
p.000975: (a) IN GENERAL.—The total principal amount of new loans made and installments paid pursuant to lines of credit
p.000975: (as defined in section 719) to borrowers covered by Federal loan insurance under this subpart shall not
p.000975: exceed $350,000,000 for fiscal year 1993, $375,000,000 for fiscal year 1994, and $425,000,000 for fiscal year 1995.
p.000975: If the total amount of new loans made and installments paid pursuant to lines of credit in any fiscal year is
p.000975: less than the ceiling established for such year, the difference between the loans made and installments
p.000975: paid and the ceiling shall be carried over
p.000975: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000975:
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p.000977: PUBLIC HEALTH SERVICE ACT
p.000977: Sec. 702
p.000977:
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p.000977: paid pursuant to lines of credit) to enable stu- dents, who have obtained prior loans insured under
p.000977: this subpart, to continue or complete their educational program or to obtain a loan under section
p.000977: 705(a)(1)(B) to pay interest on such prior loans; but no insurance may be granted for any loan made or installment paid
p.000977: after September 30, 1998. The total principal amount of Fed- eral loan insurance available under this subsection shall
p.000977: be grant- ed by the Secretary without regard to any apportionment for the purpose of chapter 15 of title 31,
p.000977: United States Code, and without regard to any similar limitation.
p.000977: (b) CERTAIN LIMITATIONS AND PRIORITIES.—
p.000977: (1) LIMITATIONS REGARDING LENDERS, STATES, OR AREAS.— The Secretary may, if necessary to assure an equitable
p.000977: dis- tribution of the benefits of this subpart, assign, within the maximum amounts specified in subsection
p.000977: (a), Federal loan in- surance quotas applicable to eligible lenders, or to States or areas, and may from time
p.000977: to time reassign unused portions of these quotas.
p.000977: (2) PRIORITY FOR CERTAIN LENDERS.—In providing certifi- cates of insurance under section 706 through
p.000977: comprehensive contracts, the Secretary shall give priority to eligible lenders that agree—
p.000977: (A) to make loans to students at interest rates below the rates prevailing, during the period involved,
p.000977: for loans covered by Federal loan insurance pursuant to this sub- part; or
p.000977: (B) to make such loans under terms that are otherwise favorable to the student relative to the terms under which
p.000977: eligible lenders are generally making such loans during such period.
p.000977: (c) AUTHORITY OF STUDENT LOAN MARKETING ASSOCIATION.—
p.000977: (1) IN GENERAL.—Subject to paragraph (2), the Student Loan Marketing Association, established under part B
p.000977: of title IV of the Higher Education Act of 1965, is authorized to make advances on the security of, purchase,
p.000977: service, sell, consolidate, or otherwise deal in loans which are insured by the Secretary under this
p.000977: subpart, except that if any loan made under this subpart is included in a consolidated loan pursuant to the au-
p.000977: thority of the Association under part B of title IV of the Higher Education Act of 1965, the interest rate on
p.000977: such consolidated loan shall be set at the weighted average interest rate of all such loans offered for
p.000977: consolidation and the resultant per cen- tum shall be rounded downward to the nearest one-eighth of
p.000977: 1 per centum, except that the interest rate shall be no less than the applicable interest rate of the
p.000977: guaranteed student loan program established under part B of title IV of the Higher Education Act of 1965. In the case
p.000977: of such a consolidated loan, the borrower shall be responsible for any interest which ac-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000977:
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p.000977: Sec. 703 PUBLIC HEALTH SERVICE ACT 978
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p.000977: January 30, 2020
p.000977:
p.000977: crues prior to the beginning of the repayment period of the loan, or which accrues during a period in which
p.000977: principal need not be paid (whether or not such principal is in fact paid) by reason of any provision
p.000977: of the Higher Education Act of 1965.
p.000977: (2) APPLICABILITY OF CERTAIN FEDERAL REGULATIONS.— With respect to Federal regulations for lenders,
p.000977: this subpart may not be construed to preclude the applicability of such reg- ulations to the Student Loan
p.000977: Marketing Association or to any other entity in the business of purchasing student loans, in- cluding such
p.000977: regulations with respect to applications, contracts, and due diligence.
p.000977: SEC. 703. ø292b¿ LIMITATIONS ON INDIVIDUAL INSURED LOANS AND ON LOAN INSURANCE.
p.000977: (a) IN GENERAL.—The total of the loans made to a student in any academic year or its equivalent (as
p.000977: determined by the Sec- retary) which may be covered by Federal loan insurance under this subpart may not exceed
p.000977: $20,000 in the case of a student enrolled in a school of medicine, osteopathic medicine, dentistry, veterinary
p.000977: medicine, optometry, or podiatric medicine, and $12,500 in the case of a student enrolled in a school of pharmacy,
p.000977: public health, allied health, or chiropractic, or a graduate program in health adminis- tration or behavioral
p.000977: and mental health practice, including clinical psychology. The aggregate insured unpaid principal amount for all such
p.000977: insured loans made to any borrower shall not at any time ex- ceed $80,000 in the case of a borrower who is or was a
p.000977: student en- rolled in a school of medicine, osteopathic medicine, dentistry, vet- erinary medicine, optometry, or
p.000977: podiatric medicine, and $50,000 in the case of a borrower who is or was a student enrolled in a school of pharmacy,
p.000977: public health, allied health, or chiropractic, or a grad- uate program in health administration or clinical
p.000977: psychology. The annual insurable limit per student shall not be exceeded by a line of credit under which actual
p.000977: payments by the lender to the bor- rower will not be made in any year in excess of the annual limit.
p.000977: (b) EXTENT OF INSURANCE LIABILITY.—The insurance liability on any loan insured by the Secretary
p.000977: under this subpart shall be 100 percent of the unpaid balance of the principal amount of the loan plus
p.000977: interest. The full faith and credit of the United States is pledged to the payment of all amounts which may be
p.000977: required to be paid under the provisions of section 707 or 714.
p.000977: SEC. 704. ø292c¿ SOURCES OF FUNDS.
p.000977: Loans made by eligible lenders in accordance with this subpart shall be insurable by the Secretary whether made from
p.000977: funds fully owned by the lender or from funds held by the lender in a trust or similar capacity and
p.000977: available for such loans.
p.000977: SEC. 705. ø292d¿ ELIGIBILITY OF BORROWERS AND TERMS OF IN- SURED LOANS.
p.000977: (a) IN GENERAL.—A loan by an eligible lender shall be insur- able by the Secretary under the provisions of
p.000977: this subpart only if—
p.000977: (1) made to—
p.000977: (A) a student who—
p.000977: (i)(I) has been accepted for enrollment at an eligi- ble institution, or (II) in the case of a student attend-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000979: 979
p.000979: PUBLIC HEALTH SERVICE ACT
p.000979: Sec. 705
p.000979:
p.000979: ing an eligible institution, is in good standing at that institution, as determined by the institution;
p.000979: (ii) is or will be a full-time student at the eligible institution;
p.000979: (iii) has agreed that all funds received under such loan shall be used solely for tuition, other reasonable
p.000979: educational expenses, including fees, books, and lab- oratory expenses, and reasonable living expenses, in-
p.000979: curred by such students;
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section; and
p.000979: (v) in the case of a pharmacy student, has satis- factorily completed three years of training; or
p.000979: (B) an individual who—
p.000979: (i) has previously had a loan insured under this subpart when the individual was a full-time student at an
p.000979: eligible institution;
p.000979: (ii) is in a period during which, pursuant to para- graph (2), the principal amount of such previous loan need
p.000979: not be paid;
p.000979: (iii) has agreed that all funds received under the proposed loan shall be used solely for repayment of in-
p.000979: terest due on previous loans made under this subpart; and
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section;
p.000979: (2) evidenced by a note or other written agreement which—
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p.000979: January 30, 2020
p.000979: (A) is made without security and without endorse- ment, except that if the borrower is a minor and such note or
p.000979: other written agreement executed by him would not, under the applicable law, create a binding obligation,
p.000979: an endorsement may be required;
p.000979: (B) provides for repayment of the principal amount of the loan in installments over a period of not
p.000979: less than 10 years (unless sooner repaid) nor more than 25 years begin- ning not earlier than 9 months nor
p.000979: later than 12 months after the date of—
p.000979: (i) the date on which—
p.000979: (I) the borrower ceases to be a participant in an accredited internship or residency program of not more
p.000979: than four years in duration;
...

p.000981: later than the date upon which repayment of the first installment of principal falls due or the date
p.000981: repayment of principal is required to re- sume (whichever is applicable) and may further provide that, on
p.000981: such date, the amount of the interest which has so accrued may be added to the principal for the purposes of
p.000981: calculating a repayment schedule;
p.000981: (E) offers, in accordance with criteria prescribed by regulation by the Secretary, a schedule for
p.000981: repayment of principal and interest under which payment of a portion of the principal and interest otherwise
p.000981: payable at the begin- ning of the repayment period (as defined in such regula- tions) is deferred until a
p.000981: later time in the period;
p.000981: (F) entitles the borrower to accelerate without penalty repayment of the whole or any part of the loan;
p.000981: (G) provides that the check for the proceeds of the loan shall be made payable jointly to the borrower and the eligi-
p.000981: ble institution in which the borrower is enrolled; and
p.000981: (H) contains such other terms and conditions con- sistent with the provisions of this subpart and with
p.000981: the regulations issued by the Secretary pursuant to this sub- part, as may be agreed upon by the
p.000981: parties to such loan, including, if agreed upon, a provision requiring the bor- rower to pay to the lender,
p.000981: in addition to principal and in- terest, amounts equal to the insurance premiums payable by the lender to
p.000981: the Secretary with respect to such loan; and
p.000981: (3) subject to the consent of the student and subject to ap- plicable law, the eligible lender has obtained from the
p.000981: student appropriate demographic information regarding the student, including racial or ethnic background.
p.000981: (b) LIMITATION ON RATE OF INTEREST.—The rate of interest prescribed and defined by the Secretary for the
p.000981: purpose of sub- section (a)(2)(D) may not exceed the average of the bond equivalent rates of the 91-day Treasury
p.000981: bills auctioned for the previous quar-
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p.000981: January 30, 2020
p.000981: 1 So in law. Probably should include another closing parenthesis.
p.000981: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000981: Sec. 706 PUBLIC HEALTH SERVICE ACT 982
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p.000981: January 30, 2020
p.000981:
p.000981: ter plus 3 percentage points, rounded to the next higher one-eighth of 1 percent.
p.000981: (c) MINIMUM ANNUAL PAYMENT BY BORROWER.—The total of the payments by a borrower during any year or any
p.000981: repayment pe- riod with respect to the aggregate amount of all loans to that bor- rower which are insured under this
p.000981: subpart shall not be less than the annual interest on the outstanding principal, except as pro- vided in
p.000981: subsection (a)(2)(C), unless the borrower, in the written agreement described in subsection (a)(2), agrees to
p.000981: make payments during any year or any repayment period in a lesser amount.
p.000981: (d) APPLICABILITY OF CERTAIN LAWS ON RATE OR AMOUNT OF INTEREST.—No provision of any law of the United
p.000981: States (other than subsections (a)(2)(D) and (b)) or of any State that limits the rate or amount of
p.000981: interest payable on loans shall apply to a loan insured under this subpart.
p.000981: (e) DETERMINATION REGARDING FORBEARANCE.—Any period of time granted to a borrower under this subpart in
p.000981: the form of for- bearance on the loan shall not be included in the 25-year total loan repayment period under
p.000981: subsection (a)(2)(C).
p.000981: (f) LOAN REPAYMENT SCHEDULE.—Lenders and holders under this subpart shall offer borrowers graduated loan
p.000981: repayment sched- ules that, during the first 5 years of loan repayment, are based on the borrower’s debt-to-income
p.000981: ratio.
p.000981: (g) RULE OF CONSTRUCTION REGARDING DETERMINATION OF NEED OF STUDENTS.—With respect to any
p.000981: determination of the fi- nancial need of a student for a loan covered by Federal loan insur- ance under this
p.000981: subpart, this subpart may not be construed to limit the authority of any school to make such allowances for
p.000981: students with special circumstances as the school determines appropriate.
p.000981: (h) DEFINITIONS.—For purposes of this section:
p.000981: (1) The term ‘‘active duty’’ has the meaning given such term in section 101(18) of title 37, United
p.000981: States Code, except that such term does not include active duty for training.
p.000981: (2) The term ‘‘Persian Gulf conflict’’ means the period be- ginning on August 2, 1990, and ending on
p.000981: the date thereafter prescribed by Presidential proclamation or by law.
p.000981: SEC. 706. ø292e¿ CERTIFICATE OF LOAN INSURANCE; EFFECTIVE DATE OF INSURANCE.
p.000981: (a) IN GENERAL.—
p.000981: (1) AUTHORITY FOR ISSUANCE OF CERTIFICATE.—If, upon ap- plication by an eligible lender, made upon such
p.000981: form, con- taining such information, and supported by such evidence as the Secretary may require, and
p.000981: otherwise in conformity with this section, the Secretary finds that the applicant has made a loan to an
p.000981: eligible borrower which is insurable under the pro- visions of this subpart, he may issue to the applicant a certifi-
p.000981: cate of insurance covering the loan and setting forth the amount and terms of the insurance.
p.000981: (2) EFFECTIVE DATE OF INSURANCE.—Insurance evidenced by a certificate of insurance pursuant to subsection
p.000981: (a)(1) shall become effective upon the date of issuance of the certificate, ex- cept that the Secretary is authorized,
p.000981: in accordance with regu- lations, to issue commitments with respect to proposed loans, or with respect to lines
p.000981: (or proposed lines) of credit, submitted
p.000981: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000983: 983
p.000983: PUBLIC HEALTH SERVICE ACT
p.000983: Sec. 706
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p.000983: January 30, 2020
p.000983: by eligible lenders, and in that event, upon compliance with subsection (a)(1) by the lender, the certificate
p.000983: of insurance may be issued effective as of the date when any loan, or any pay- ment by the lender
p.000983: pursuant to a line of credit, to be covered by such insurance is made to a student described in
p.000983: section 705(a)(1). Such insurance shall cease to be effective upon 60 days’ default by the lender in the
p.000983: payment of any installment of the premiums payable pursuant to section 708.
p.000983: (3) CERTAIN AGREEMENTS FOR LENDERS.—An application submitted pursuant to subsection (a)(1) shall contain—
p.000983: (A) an agreement by the applicant to pay, in accord- ance with regulations, the premiums fixed by the
p.000983: Sec- retary pursuant to section 708; and
p.000983: (B) an agreement by the applicant that if the loan is covered by insurance the applicant will submit
p.000983: such sup- plementary reports and statements during the effective pe- riod of the loan agreement, upon such
p.000983: forms, at such times, and containing such information as the Secretary may prescribe by or pursuant to
p.000983: regulation.
p.000983: (b) AUTHORITY REGARDING COMPREHENSIVE INSURANCE COV-
p.000983: ERAGE.—
p.000983: (1) IN GENERAL.—In lieu of requiring a separate insurance application and issuing a separate certificate of
p.000983: insurance for each loan made by an eligible lender as provided in subsection (a), the Secretary may, in
p.000983: accordance with regulations con- sistent with section 702, issue to any eligible lender applying therefor
p.000983: a certificate of comprehensive insurance coverage which shall, without further action by the Secretary,
p.000983: insure all insurable loans made by that lender, on or after the date of the certificate and before a specified
p.000983: cutoff date, within the limits of an aggregate maximum amount stated in the certificate. Such regulations
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p.000983: Sec. 707 PUBLIC HEALTH SERVICE ACT 984
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p.000983: tion 702, the Secretary may, in accordance with regulations, make commitments to insure such future loans
p.000983: or payments, and such commitments may be honored either as provided in subsection (a) or by inclusion of
p.000983: such insurance in comprehen- sive coverage under this subsection for the period or periods in which such future loans
p.000983: or payments are made.
p.000983: (c) ASSIGNMENT OF INSURANCE RIGHTS.—The rights of an eligi- ble lender arising under insurance evidenced by a
p.000983: certificate of in- surance issued to it under this section may be assigned by such lender, subject to
p.000983: regulation by the Secretary, only to—
p.000983: (1) another eligible lender (including a public entity in the business of purchasing student loans); or
p.000983: (2) the Student Loan Marketing Association.
p.000983: (d) EFFECT OF REFINANCING OR CONSOLIDATION OF OBLIGA- TIONS.—The consolidation of the obligations of
p.000983: two or more feder- ally insured loans obtained by a borrower in any fiscal year into a single
p.000983: obligation evidenced by a single instrument of indebted- ness or the refinancing of a single loan shall
p.000983: not affect the insur- ance by the United States. If the loans thus consolidated are cov- ered by
p.000983: separate certificates of insurance issued under subsection (a), the Secretary may upon surrender of the
p.000983: original certificates issue a new certificate of insurance in accordance with that sub- section upon the
p.000983: consolidated obligation. If the loans thus consoli- dated are covered by a single comprehensive
p.000983: certificate issued under subsection (b), the Secretary may amend that certificate ac- cordingly.
p.000983: (e) RULE OF CONSTRUCTION REGARDING CONSOLIDATION OF DEBTS AND REFINANCING.—Nothing in this section
p.000983: shall be con- strued to preclude the lender and the borrower, by mutual agree- ment, from consolidating
p.000983: all of the borrower’s loans insured under this subpart into a single instrument (or, if the borrower
p.000983: obtained only 1 loan insured under this subpart, refinancing the loan 1 time) under the terms applicable to an
p.000983: insured loan made at the same time as the consolidation. The lender or loan holder should provide full information
...

p.000989: (2) EXCEPTIONS.—In carrying out this section with respect to an institution, the Secretary may grant an
p.000989: institution a waiver of requirements of paragraphs (2) through (4) of sub- section (b) if the Secretary
p.000989: determines that the default rate for such institution is not an accurate indicator because the vol- ume of
p.000989: the loans under this subpart made by such institution has been insufficient.
p.000989: (3) TRANSITION FOR CERTAIN INSTITUTIONS.—During the 3- year period beginning on the effective date of the
p.000989: Health Pro- fessions Education Extension Amendments of 1992—
p.000989: (A) subsection (b)(4) shall not apply with respect to any eligible institution that is a Historically Black
p.000989: College or University; and
p.000989: (B) any such institution that has a default rate in ex- cess of 20 percent, and any eligible borrower seeking
p.000989: a loan for attendance at the institution, shall be subject to subsection (b)(3) to the same extent and in the
p.000989: same man- ner as eligible institutions and borrowers described in such subsection.
p.000989: (e) PAYOFF TO REDUCE RISK CATEGORY.—An institution may pay off the outstanding principal and interest
p.000989: owed by the bor- rowers of such institution who have defaulted on loans made under this subpart in order to reduce
p.000989: the risk category of the institution.
p.000989: SEC. 709. ø292h¿ OFFICE FOR HEALTH EDUCATION ASSISTANCE LOAN DEFAULT REDUCTION.
p.000989: (a) ESTABLISHMENT.—The Secretary shall establish, within the Division of Student Assistance of the Bureau of Health
p.000989: Professions, an office to be known as the Office for Health Education Assistance Loan Default Reduction (in this
p.000989: section referred to as the ‘‘Office’’).
p.000989: (b) PURPOSE AND FUNCTIONS.—It shall be the purpose of the Office to achieve a reduction in the number
p.000989: and amounts of de- faults on loans guaranteed under this subpart. In carrying out such purpose the Office shall—
p.000989: (1) conduct analytical and evaluative studies concerning loans and loan defaults;
p.000989: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000989:
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p.000991: 991
p.000991: PUBLIC HEALTH SERVICE ACT
p.000991: Sec. 710
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p.000991: January 30, 2020
p.000991: (2) carry out activities designed to reduce loan defaults;
p.000991: (3) respond to special circumstances that may exist in the financial lending environment that may lead to loan
p.000991: defaults;
p.000991: (4) coordinate with other Federal entities that are involved with student loan programs, including—
p.000991: (A) with respect to the Department of Education, in the development of a single student loan application form,
p.000991: a single student loan deferment form, a single disability form, and a central student loan database; and
p.000991: (B) with respect to the Department of Justice, in the recovery of payments from health professionals who
p.000991: have defaulted on loans guaranteed under this subpart; and
p.000991: (5) provide technical assistance to borrowers, lenders, hold- ers, and institutions concerning deferments and
p.000991: collection ac- tivities.
p.000991: (c) ADDITIONAL DUTIES.—In conjunction with the report sub- mitted under subsection (b), the Office shall—
p.000991: (1) compile, and publish in the Federal Register, a list of the borrowers who are in default under this
p.000991: subpart; and
p.000991: (2) send the report and notices of default with respect to these borrowers to relevant Federal agencies
p.000991: and to schools, school associations, professional and specialty associations, State licensing boards,
p.000991: hospitals with which such borrowers may be associated, and any other relevant organizations.
p.000991: (d) ALLOCATION OF FUNDS FOR OFFICE.—In the case of amounts reserved under section 710(a)(2)(B)
p.000991: for obligation under this subsection, the Secretary may obligate the amounts for the purpose of
p.000991: administering the Office, including 7 full-time equiva- lent employment positions for such Office. With
p.000991: respect to such purpose, amounts made available under the preceding sentence are in addition to amounts made
p.000991: available to the Health Resources and Services Administration for program management for the fiscal year
p.000991: involved. With respect to such employment positions, the posi- tions are in addition to the number of full-time
p.000991: equivalent employ- ment positions that otherwise is authorized for the Department of Health and Human Services
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p.000991: necessary to protect the financial interest of the United States.
p.000991: (4) Subject to the specific limitations in the subpart, to consent to the modification of any note or other
p.000991: instrument evi- dencing a loan which has been insured by him under this sub- part (including modifications with
p.000991: respect to the rate of inter- est, time of payment of any installment of principal and inter- est or any portion
p.000991: thereof, or any other provision).
p.000991: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000993: PUBLIC HEALTH SERVICE ACT
p.000993: Sec. 715
p.000993:
p.000993: (5) To enforce, pay, compromise, waive, or release any right, title, claim, lien, or demand, however acquired,
p.000993: including any equity or any right or 2 redemption.
p.000993: (b) ANNUAL BUDGET; ACCOUNTS.—The Secretary shall, with re- spect to the financial operations arising by reason of this
p.000993: subpart—
p.000993: (1) prepare annually and submit a budget program as pro- vided for wholly owned Government corporations by the
p.000993: Gov- ernment Corporation Control Act; and
p.000993: (2) maintain with respect to insurance under this subpart an integral set of accounts.
p.000993: SEC. 712. ø292k¿ PARTICIPATION BY FEDERAL CREDIT UNIONS IN FED- ERAL, STATE, AND PRIVATE STUDENT LOAN INSURANCE
p.000993: PROGRAMS.
p.000993: Notwithstanding any other provision of law, Federal credit unions shall, pursuant to regulations of the
p.000993: Administrator of the National Credit Union Administration, have power to make in- sured loans to eligible
p.000993: students in accordance with the provisions of this subpart relating to Federal insured loans.
p.000993: SEC. 713. ø292l¿ DETERMINATION OF ELIGIBLE STUDENTS.
p.000993: For purposes of determining eligible students under this part, in the case of a public school in a State that
p.000993: offers an accelerated, integrated program of study combining undergraduate premedical education and medical
p.000993: education leading to advanced entry, by con- tractual agreement, into an accredited four-year school of medicine which
p.000993: provides the remaining training leading to a degree of doctor of medicine, whenever in this part a provision
p.000993: refers to a student at a school of medicine, such reference shall include only a student enrolled in any of the last
p.000993: four years of such accelerated, integrated program of study.
p.000993: SEC. 714. ø292m¿ REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR DISABLED BORROWERS.
p.000993: If a borrower who has received a loan dies or becomes perma- nently and totally disabled (as determined in accordance
p.000993: with regu- lations of the Secretary), the Secretary shall discharge the bor- rower’s liability on the loan
p.000993: by repaying the amount owed on the loan from the account established under section 710.
p.000993: SEC. 715. ø292n¿ ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.
p.000993: (a) IN GENERAL.—Notwithstanding any other provision of this subpart, the Secretary is authorized to
p.000993: prescribe such regulations as may be necessary to provide for—
p.000993: (1) a fiscal audit of an eligible institution with regard to any funds obtained from a borrower who
p.000993: has received a loan insured under this subpart;
p.000993: (2) the establishment of reasonable standards of financial responsibility and appropriate institutional
p.000993: capability for the administration by an eligible institution of a program of stu- dent financial aid with
p.000993: respect to funds obtained from a stu- dent who has received a loan insured under this subpart;
p.000993:
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p.000993: January 30, 2020
p.000993: 2 So in law. See section 102 of Public Law 102–408 (106 Stat. 1994). Probably should be ‘‘right of redemption’’.
p.000993: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000993:
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p.000993: Default Reduction, of information concerning each loan made under this subpart, including the date when
p.000993: each such loan was originated, the date when each such loan is sold, the identity of the loan hold- er and
p.000993: information concerning a change in the borrower’s sta- tus;
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p.000993: January 30, 2020
p.000993: (7) the withholding of services, including academic tran- scripts, financial aid transcripts, and alumni
p.000993: services, by an in- stitution from a borrower upon the default of such borrower of a loan under this subpart, except in
p.000993: case of a borrower who has filed for bankruptcy; and
p.000993: (8) the offering, by the lender to the borrower, of a variety of repayment options, including fixed-rate,
p.000993: graduated repay- ment with negative amortization permitted, and income de- pendent payments for a limited
p.000993: period followed by level month- ly payments.
p.000993: (b) RECORDING BY INSTITUTION OF INFORMATION ON STU- DENTS.—The Secretary shall require an
p.000993: eligible institution to record, and make available to the lender and to the Secretary upon request, the name,
p.000993: address, postgraduate destination, and other reasonable identifying information for each student of such institu-
p.000993: tion who has a loan insured under this subpart.
p.000993: (c) WORKSHOP FOR STUDENT BORROWERS.—Each participating eligible institution must have, at the beginning of
p.000993: each academic year, a workshop concerning the provisions of this subpart that all student borrowers shall be required
p.000993: to attend.
p.000993: SEC. 719. ø292o¿ DEFINITIONS.
p.000993: For purposes of this subpart:
p.000993: (1) The term ‘‘eligible institution’’ means, with respect to a fiscal year, a school of medicine,
p.000993: osteopathic medicine, den- tistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public
p.000993: health, allied health, or chiropractic, or a graduate program in health administration or behavioral and
p.000993: mental health practice, including clinical psychology.
p.000993: (2) The term ‘‘eligible lender’’ means an eligible institution that became a lender under this subpart prior to
p.000993: September 15, 1992, an agency or instrumentality of a State, a financial or credit institution (including an
p.000993: insurance company) which is subject to examination and supervision by an agency of the United States or of any
p.000993: State, a pension fund approved by the
p.000993: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000995: PUBLIC HEALTH SERVICE ACT
p.000995: Sec. 719
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p.000995: entity and that enter repayment status after April 7, 1987.
p.000995: (B) For purposes of subparagraph (A), a loan insured under this subpart shall be considered to
p.000995: have entered repay- ment status if the applicable period described in subparagraph
p.000995: (B) of section 705(a)(2) regarding the loan has expired (without regard to whether any period described in subparagraph
p.000995: (C) of such section is applicable regarding the loan).
p.000995: (C) For purposes of subparagraph (A), the term ‘‘eligible entity’’ means an eligible institution, an
p.000995: eligible lender, or a holder, as the case may be.
p.000995: (D) For purposes of subparagraph (A), a loan is made with respect to an eligible entity if—
p.000995: (i) in the case of an eligible institution, the loan was made to students of the institution;
p.000995: (ii) in the case of an eligible lender, the loan was made by the lender; and
p.000995: (iii) in the case of a holder, the loan was purchased by the holder.
p.000995: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000995:
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p.000995: Sec. 720 PUBLIC HEALTH SERVICE ACT 996
p.000995:
p.000995: (6) 3 The term ‘‘Secretary’’ means the Secretary of Edu- cation.
p.000995: SEC. 720. ø292p¿ AUTHORIZATION OF APPROPRIATIONS.
p.000995: (a) IN GENERAL.—For fiscal year 1993 and subsequent fiscal years, there are authorized to be appropriated
p.000995: such sums as may be necessary for the adequacy of the student loan insurance ac- count under this subpart
p.000995: and for the purpose of administering this subpart.
p.000995: (b) AVAILABILITY OF SUMS.—Sums appropriated under sub- section (a) shall remain available until expended.
p.000995:
p.000995: Subpart II—Federally-Supported Student Loan Funds
p.000995:
p.000995: SEC. 721. ø292q¿ AGREEMENTS FOR OPERATION OF SCHOOL LOAN FUNDS.
p.000995: (a) FUND AGREEMENTS.—The Secretary is authorized to enter into an agreement for the establishment and operation
p.000995: of a student loan fund in accordance with this subpart with any public or other nonprofit school of medicine,
p.000995: osteopathic medicine, dentistry, phar- macy, podiatric medicine, optometry, or veterinary medicine.
p.000995: (b) REQUIREMENTS.—Each agreement entered into under this section shall—
p.000995: (1) provide for establishment of a student loan fund by the school;
p.000995: (2) provide for deposit in the fund of—
p.000995: (A) the Federal capital contributions to the fund;
p.000995: (B) an amount equal to not less than one-ninth of such Federal capital contributions, contributed by such
p.000995: institu- tion;
p.000995: (C) collections of principal and interest on loans made from the fund;
p.000995: (D) collections pursuant to section 722(j); and
p.000995: (E) any other earnings of the fund;
p.000995: (3) provide that the fund shall be used only for loans to students of the school in accordance with
p.000995: the agreement and for costs of collection of such loans and interest thereon;
p.000995: (4) provide that loans may be made from such funds only to students pursuing a full-time course of
p.000995: study at the school leading to a degree of doctor of medicine, doctor of dentistry or an equivalent degree,
p.000995: doctor of osteopathy, bachelor of science in pharmacy or an equivalent degree, doctor of pharmacy or an equivalent
p.000995: degree, doctor of podiatric medicine or an equiva- lent degree, doctor of optometry or an equivalent
p.000995: degree, or doctor of veterinary medicine or an equivalent degree;
p.000995: (5) provide that the school shall advise, in writing, each applicant for a loan from the student loan
p.000995: fund of the provi- sions of section 722 under which outstanding loans from the student loan fund may be
p.000995: paid (in whole or in part) by the Sec- retary; and
p.000995:
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p.000995: January 30, 2020
p.000995: 3 Paragraph (6) was added by Section 525(e), Title V of Division H of Public Law 113-76. This paragraph becomes
p.000995: effective on the date on which the transfer of the HEAL program under sub- section (a) of such act takes effect.
p.000995: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000997: PUBLIC HEALTH SERVICE ACT
p.000997: Sec. 722
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p.000997: January 30, 2020
p.000997: (6) contain such other provisions as are necessary to pro- tect the financial interests of the United States.
p.000997: (c) FAILURE OF SCHOOL TO COLLECT LOANS.—
p.000997: (1) IN GENERAL.—Any standard established by the Sec- retary by regulation for the collection by schools
p.000997: of medicine, osteopathic medicine, dentistry, pharmacy, podiatric medicine, optometry, or veterinary medicine
p.000997: of loans made pursuant to loan agreements under this subpart shall provide that the fail- ure of any such school to
p.000997: collect such loans shall be measured in accordance with this subsection. This subsection may not be construed to
p.000997: require such schools to reimburse the student loan fund under this subpart for loans that
p.000997: became uncollectible prior to August 1985 or to penalize such schools with respect to such loans.
p.000997: (2) EXTENT OF FAILURE.—The measurement of a school’s failure to collect loans made under this subpart
p.000997: shall be the ratio (stated as a percentage) that the defaulted principal amount outstanding of such school
p.000997: bears to the matured loans of such school.
p.000997: (3) DEFINITIONS.—For purposes of this subsection:
p.000997: (A) The term ‘‘default’’ means the failure of a borrower of a loan made under this subpart to—
p.000997: (i) make an installment payment when due; or
p.000997: (ii) comply with any other term of the promissory note for such loan,
p.000997: except that a loan made under this subpart shall not be considered to be in default if the loan is
p.000997: discharged in bankruptcy or if the school reasonably concludes from written contracts with the
p.000997: borrower that the borrower in- tends to repay the loan.
p.000997: (B) The term ‘‘defaulted principal amount outstanding’’ means the total amount borrowed from the loan fund of a school
p.000997: that has reached the repayment stage (minus any principal amount repaid or canceled) on loans—
p.000997: (i) repayable monthly and in default for at least 120 days; and
p.000997: (ii) repayable less frequently than monthly and in default for at least 180 days;
p.000997: (C) The term ‘‘grace period’’ means the period of one year beginning on the date on which the borrower
p.000997: ceases to pursue a full-time course of study at a school of medi- cine, osteopathic medicine, dentistry,
p.000997: pharmacy, podiatric medicine, optometry, or veterinary medicine; and
p.000997: (D) The term ‘‘matured loans’’ means the total prin- cipal amount of all loans made by a school under this sub-
p.000997: part minus the total principal amount of loans made by such school to students who are—
p.000997: (i) enrolled in a full-time course of study at such school; or
p.000997: (ii) in their grace period.
p.000997: SEC. 722. ø292r¿ LOAN PROVISIONS.
p.000997: (a) AMOUNT OF LOAN.—
p.000997: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000997: Sec. 722 PUBLIC HEALTH SERVICE ACT 998
p.000997:
p.000997: (1) IN GENERAL.—Loans from a student loan fund (estab- lished under an agreement with a school under
p.000997: section 721) may not, subject to paragraph (2), exceed for any student for a school year (or its equivalent)
p.000997: the cost of attendance (includ- ing tuition, other reasonable educational expenses, and reason- able living costs) for
p.000997: that year at the educational institution at- tended by the student (as determined by such educational in-
p.000997: stitution).
p.000997: (2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For purposes of paragraph (1), the amount of the loan may,
p.000997: in the case of the third or fourth year of a student at a school of med- icine or osteopathic medicine, be
p.000997: increased to the extent nec- essary to pay the balances of loans that, from sources other than the
p.000997: student loan fund under section 721, were made to the individual for attendance at the school. The
p.000997: authority to make such an increase is subject to the school and the student agreeing that such amount (as
p.000997: increased) will be expended to pay such balances.
p.000997: (b) TERMS AND CONDITIONS.—Subject to section 723, any such loans shall be made on such terms and
p.000997: conditions as the school may determine, but may be made only to a student—
p.000997: (1) who is in need of the amount thereof to pursue a full- time course of study at the school leading to a
p.000997: degree of doctor of medicine, doctor of dentistry or an equivalent degree, doctor of osteopathy, bachelor of science in
p.000997: pharmacy or an equivalent degree, doctor of pharmacy or an equivalent degree, doctor of podiatric medicine or
p.000997: an equivalent degree, doctor of optometry or an equivalent degree, or doctor of veterinary medicine or an equivalent
p.000997: degree; and
p.000997: (2) who, if required under section 3 of the Military Selec- tive Service Act to present himself for
p.000997: and submit to registra- tion under such section, has presented himself and submitted to registration under
p.000997: such section.
p.000997: (c) REPAYMENT; EXCLUSIONS FROM REPAYMENT PERIOD.—Such loans shall be repayable in equal or graduated
p.000997: periodic install- ments (with the right of the borrower to accelerate repayment) over the period of not less than 10
p.000997: years nor more than 25 years, at the discretion of the institution, which begins one year after the stu- dent
p.000997: ceases to pursue a full-time course of study at a school of med- icine, osteopathic medicine, dentistry, pharmacy,
p.000997: podiatry, optom- etry, or veterinary medicine, excluding from such period—
p.000997: (1) all periods—
p.000997: (A) not in excess of three years of active duty per- formed by the borrower as a member of a uniformed serv-
p.000997: ice;
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p.000997: January 30, 2020
p.000997: (B) not in excess of three years during which the bor- rower serves as a volunteer under the Peace Corps Act;
p.000997: (C) during which the borrower participates in ad- vanced professional training, including
p.000997: internships and residencies; and
p.000997: (D) during which the borrower is pursuing a full-time course of study at such a school; and
p.000997: (2) a period—
p.000997: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000999: 999
p.000999: PUBLIC HEALTH SERVICE ACT
p.000999: Sec. 722
p.000999:
p.000999: (A) not in excess of two years during which a borrower who is a full-time student in such a school leaves the
p.000999: school, with the intent to return to such school as a full- time student, in order to engage in a full-time
p.000999: educational activity which is directly related to the health profession for which the borrower is preparing, as
p.000999: determined by the Secretary; or
p.000999: (B) not in excess of two years during which a borrower who is a graduate of such a school is a participant in a fel-
p.000999: lowship training program or a full-time educational activ- ity which—
p.000999: (i) is directly related to the health profession for which such borrower prepared at such school, as deter-
p.000999: mined by the Secretary; and
p.000999: (ii) may be engaged in by the borrower during such a two-year period which begins within twelve months
p.000999: after the completion of the borrower’s partici- pation in advanced professional training described in
p.000999: paragraph (1)(C) or prior to the completion of such borrower’s participation in such training.
p.000999: (d) CANCELLATION OF LIABILITY.—The liability to repay the un- paid balance of such a loan and accrued
p.000999: interest thereon shall be canceled upon the death of the borrower, or if the Secretary deter- mines that he has
p.000999: become permanently, and totally disabled.
p.000999: (e) RATE OF INTEREST.—Such loans shall bear interest, on the unpaid balance of the loan, computed only for
p.000999: periods for which the loan is repayable, at the rate of 5 percent per year.
p.000999: (f) SECURITY OR ENDORSEMENT.—Loans shall be made under this subpart without security or endorsement,
p.000999: except that if the borrower is a minor and the note or other evidence of obligation ex- ecuted by him would not,
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p.000999: an obligation to repay, any loan made to such person as a health professions stu- dent to enable him to study
p.000999: medicine, osteopathy, dentistry, veteri- nary medicine, optometry, pharmacy, or podiatry, the Secretary may
p.000999: undertake to repay (without liability to the applicant) all or any part of such loan, and any interest
p.000999: or portion thereof out- standing thereon, upon his determination, pursuant to regulations establishing
p.000999: criteria therefor, that the applicant—
p.000999: (1) failed to complete such studies leading to his first pro- fessional degree;
p.000999: (2) is in exceptionally needy circumstances;
p.000999: (3) is from a low-income or disadvantaged family as those terms may be defined by such regulations; and
p.000999: (4) has not resumed, or cannot reasonably be expected to resume, the study of medicine, osteopathy,
p.000999: dentistry, veteri- nary medicine, optometry, pharmacy, or podiatric medicine, within two years following the
p.000999: date upon which he terminated such studies.
p.000999: (l) COLLECTION EFFORTS BY SECRETARY.—The Secretary is au- thorized to attempt to collect any loan which was made
p.000999: under this subpart, which is in default, and which was referred to the Sec- retary by a school with
p.000999: which the Secretary has an agreement under this subpart, on behalf of that school under such terms and conditions
p.000999: as the Secretary may prescribe (including reimburse- ment from the school’s student loan fund for
p.000999: expenses the Sec- retary may reasonably incur in attempting collection), but only if the school has
p.000999: complied with such requirements as the Secretary may specify by regulation with respect to the collection
p.000999: of loans under this subpart. A loan so referred shall be treated as a debt subject to section 5514 of
p.000999: title 5, United States Code. Amounts col- lected shall be deposited in the school’s student loan fund. When-
p.000999: ever the Secretary desires the institution of a civil action regarding any such loan, the Secretary shall refer the
p.000999: matter to the Attorney General for appropriate action.
p.000999: (m) ELIMINATION OF STATUTE OF LIMITATION FOR LOAN COL-
p.000999: LECTIONS.—
p.000999: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001001: 1001
p.001001: PUBLIC HEALTH SERVICE ACT
p.001001: Sec. 723
p.001001:
p.001001: (1) PURPOSE.—It is the purpose of this subsection to en- sure that obligations to repay loans under this
p.001001: section are en- forced without regard to any Federal or State statutory, regu- latory, or administrative
p.001001: limitation on the period within which debts may be enforced.
p.001001: (2) PROHIBITION.—Notwithstanding any other provision of Federal or State law, no limitation shall terminate
p.001001: the period within which suit may be filed, a judgment may be enforced, or an offset, garnishment, or
p.001001: other action may be initiated or taken by a school that has an agreement with the Secretary pursuant to
p.001001: section 721 that is seeking the repayment of the amount due from a borrower on a loan made under
p.001001: this sub- part after the default of the borrower on such loan.
p.001001: SEC. 723. ø292s¿ MEDICAL SCHOOLS AND PRIMARY HEALTH CARE.
p.001001: (a) REQUIREMENTS FOR STUDENTS.—
p.001001: (1) IN GENERAL.—Subject to the provisions of this sub- section, in the case of student loan funds
p.001001: established under section 721 by schools of medicine or osteopathic medicine, each agreement entered into
p.001001: under such section with such a school shall provide (in addition to the provisions required in subsection
p.001001: (b) of such section) that the school will make a loan from such fund to a student only if the student agrees—
p.001001: (A) to enter and complete a residency training pro- gram in primary health care not later than 4 years
p.001001: after the date on which the student graduates from such school; and
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p.001001: (B) to practice in such care for 10 years (including residency training in primary health care) or
p.001001: through the date on which the loan is repaid in full, whichever occurs first.
p.001001: (2) INAPPLICABILITY TO CERTAIN STUDENTS.—
p.001001: (A) The requirement established in paragraph (1) re- garding the student loan fund of a school does not
p.001001: apply to a student if—
p.001001: (i) the first loan to the student from such fund is made before July 1, 1993; or
p.001001: (ii) the loan is made from—
p.001001: (I) a Federal capital contribution under sec- tion 721 that is made from amounts appropriated under section
p.001001: 724(f) (in this section referred to as an ‘‘exempt Federal capital contribution’’); or
p.001001: (II) a school contribution made under section 721 pursuant to such a Federal capital contribu- tion (in
p.001001: this section referred to as an ‘‘exempt school contribution’’).
p.001001: (B) A Federal capital contribution under section 721 may not be construed as being an exempt Federal
p.001001: capital contribution if the contribution was made from amounts appropriated before October 1, 1990. A school
p.001001: contribution under section 721 may not be construed as being an ex- empt school contribution if the
p.001001: contribution was made pur- suant to a Federal capital contribution under such section
p.001001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001001: Sec. 723 PUBLIC HEALTH SERVICE ACT 1002
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p.001001: that was made from amounts appropriated before such date.
p.001001: (3) NONCOMPLIANCE BY STUDENT.—Each agreement en- tered into with a student pursuant to paragraph (1) shall
p.001001: pro- vide that, if the student fails to comply with such agreement, the loan involved will begin to
p.001001: accrue interest at a rate of 2 percent per year greater than the rate at which the student would pay if
p.001001: compliant in such year.
p.001001: (4) WAIVERS.—
p.001001: (A) With respect to the obligation of an individual under an agreement made under paragraph (1) as a
p.001001: stu- dent, the Secretary shall provide for the partial or total waiver or suspension of the obligation
p.001001: whenever compli- ance by the individual is impossible, or would involve ex- treme hardship to the individual,
p.001001: and if enforcement of the obligation with respect to the individual would be uncon- scionable.
p.001001: (B) For purposes of subparagraph (A), the obligation of an individual shall be waived if—
p.001001: (i) the status of the individual as a student of the school involved is terminated before graduation from the
p.001001: school, whether voluntarily or involuntarily; and
p.001001: (ii) the individual does not, after such termination, resume attendance at the school or begin attendance at
p.001001: any other school of medicine or osteopathic medi- cine.
p.001001: (C) If an individual resumes or begins attendance for purposes of subparagraph (B), the obligation of
p.001001: the indi- vidual under the agreement under paragraph (1) shall be considered to have been suspended for the
p.001001: period in which the individual was not in attendance.
p.001001: (D) This paragraph may not be construed as author- izing the waiver or suspension of the obligation of
p.001001: a stu- dent to repay, in accordance with section 722, loans from student loan funds under section 721.
p.001001: (b) REQUIREMENTS FOR SCHOOLS.—
p.001001: (1) IN GENERAL.—Subject to the provisions of this sub- section, in the case of student loan funds
p.001001: established under section 721 by schools of medicine or osteopathic medicine, each agreement entered into
p.001001: under such section with such a school shall provide (in addition to the provisions required in subsection
p.001001: (b) of such section) that, for the 1-year period end- ing on June 30, 1997; 5 and for the 1-year
p.001001: period ending on June 30 of each subsequent fiscal year, the school will meet not less than 1 of the conditions
p.001001: described in paragraph (2) with respect to graduates of the school whose date of graduation from the
p.001001: school occurred approximately 4 years before the end of the 1-year period involved.
p.001001: (2) DESCRIPTION OF CONDITIONS.—With respect to grad- uates described in paragraph (1) (in this paragraph
p.001001: referred to
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p.001001: January 30, 2020
p.001001: 5 So in law. See section 2014(c)(2)(A)(i) of Public Law 103–43 (107 Stat. 216). The semicolon probably
p.001001: should be a comma.
p.001001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001003: 1003
p.001003: PUBLIC HEALTH SERVICE ACT
p.001003: Sec. 723
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p.001003: as ‘‘designated graduates’’), the conditions referred to in such paragraph for a school for a 1-year period are
p.001003: as follows:
p.001003: (A) Not less than 50 percent of designated graduates of the school meet the criterion of either being
p.001003: in a resi- dency training program in primary health care, or being engaged in a practice in such care (having
p.001003: completed such a program).
p.001003: (B) Not less than 25 percent of the designated grad- uates of the school meet such criterion, and such
p.001003: percent- age is not less than 5 percentage points above the percent- age of such graduates meeting such
p.001003: criterion for the pre- ceding 1-year period.
p.001003: (C) In the case of schools of medicine or osteopathic medicine with student loans funds under section
p.001003: 721, the school involved is at or above the 75th percentile of such schools whose designated graduates meet
p.001003: such criterion.
p.001003: (3) DETERMINATIONS BY SECRETARY.—Not later than 90 days after the close of each 1-year period described
p.001003: in para- graph (1), the Secretary shall make a determination of whether the school involved has for such period
p.001003: complied with such paragraph and shall in writing inform the school of the deter- mination. Such determination shall
p.001003: be made only after consid- eration of the report submitted to the Secretary by the school under paragraph
p.001003: (6).
p.001003: (4) NONCOMPLIANCE BY SCHOOL.—
p.001003: (A)(i) Subject to subparagraph (C), each agreement under section 721 with a school of medicine or osteopathic
p.001003: medicine shall provide that, if the school fails to comply with paragraph (1) for a 1-year period under
p.001003: such para- graph, the school—
p.001003: (I) will pay to the Secretary the amount appli- cable under subparagraph (B) for the period; and
p.001003: (II) will pay such amount not later than 90 days after the school is informed under paragraph
p.001003: (3) of the determination of the Secretary regarding such period.
p.001003: (ii) Any amount that a school is required to pay under clause (i) may be paid from the student loan fund of
p.001003: the school under section 721.
p.001003: (B) For purposes of subparagraph (A), the amount ap- plicable for a school, subject to subparagraph (C), is—
p.001003: (i) for the 1-year period ending June 30, 1997, an amount equal to 10 percent of the income received during
p.001003: such period by the student loan fund of the school under section 721;
p.001003: (ii) for the 1-year period ending June 30, 1998, an amount equal to 20 percent of the income received during
p.001003: such period by the student loan fund; and
p.001003: (iii) for any subsequent 1-year period under para- graph (1), an amount equal to 30 percent of the in- come
p.001003: received during such period by the student loan fund.
p.001003: (C) In determining the amount of income that a stu- dent loan fund has received for purposes of
p.001003: subparagraph
p.001003: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001003: Sec. 724 PUBLIC HEALTH SERVICE ACT 1004
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p.001003: (B), the Secretary shall exclude any income derived from exempt contributions. Payments made to the
p.001003: Secretary under subparagraph (A) may not be made with such con- tributions or with income derived from such
p.001003: contributions.
p.001003: (5) EXPENDITURE OF PAYMENTS.—
p.001003: (A) Amounts paid to the Secretary under paragraph
p.001003: (4) shall be expended to make Federal capital contribu- tions to student loan funds under section 721
p.001003: of schools that are in compliance with paragraph (1).
p.001003: (B) A Federal capital contribution under section 721 may not be construed as being an exempt Federal
p.001003: capital contribution if the contribution is made from payments under subparagraph (A). A school contribution
p.001003: under such section may not be construed as being an exempt school contribution if the contribution is made
p.001003: pursuant to a Fed- eral capital contribution from such payments.
p.001003: (6) REPORTS BY SCHOOLS.—Each agreement under section 721 with a school of medicine or osteopathic
p.001003: medicine shall provide that the school will submit to the Secretary a report for each 1-year period
p.001003: under paragraph (1) that provides such information as the Secretary determines to be necessary for
p.001003: carrying out this subsection. Each such report shall include statistics concerning the current training or
p.001003: practice status of all graduates of such school whose date of graduation from the school occurred approximately 4
p.001003: years before the end of the 1- year period involved.
p.001003: (c) DEFINITIONS.—For purposes of this section:
p.001003: (1) The term ‘‘exempt contributions’’ means exempt Fed- eral capital contributions and exempt school
p.001003: contributions.
p.001003: (2) The term ‘‘exempt Federal capital contribution’’ means a Federal capital contribution described in subclause
p.001003: (I) of sub- section (a)(2)(A)(ii).
p.001003: (3) The term ‘‘exempt school contribution’’ means a school contribution described in subclause (II)
p.001003: of subsection (a)(2)(A)(ii).
p.001003: (4) The term ‘‘income’’, with respect to a student fund under section 721, means payments of principal
p.001003: and interest on any loan made from the fund, and any other earnings of the fund.
p.001003: (5) The term ‘‘primary health care’’ means family medicine, general internal medicine, general pediatrics, preventive
p.001003: medi- cine, or osteopathic general practice.
p.001003: (d) SENSE OF CONGRESS.—It is the sense of Congress that funds repaid under the loan program under this section
p.001003: should not be transferred to the Treasury of the United States or otherwise used for any other purpose other
p.001003: than to carry out this section.
p.001003: SEC. 724. ø292t¿ INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.
p.001003: (a) FUND AGREEMENTS REGARDING CERTAIN AMOUNTS.—With respect to amounts appropriated under subsection (f),
p.001003: each agree- ment entered into under section 721 with a school shall provide (in addition to the provisions required in
p.001003: subsection (b) of such section) that—
p.001003: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001005: 1005
p.001005: PUBLIC HEALTH SERVICE ACT
p.001005: Sec. 724
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p.001005: (1) any Federal capital contribution made to the student loan fund of the school from such amounts,
p.001005: together with the school contribution appropriate under subsection (b)(2)(B) of such section to the amount of
p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
p.001005: (2) collections of principal and interest on loans made pur- suant to paragraph (1), and any other earnings of the
p.001005: student loan fund attributable to amounts that are in the fund pursu- ant to such paragraph, will be utilized only for
p.001005: the purpose de- scribed in such paragraph.
p.001005: (b) MINIMUM QUALIFICATIONS FOR SCHOOLS.—The Secretary may not make a Federal capital contribution for
p.001005: purposes of sub- section (a) for a fiscal year unless the health professions school in- volved—
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p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
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p.001005: regarding the completion of the educational requirements for degrees from the school;
p.001005: (5) to be carrying out each of the activities specified in any of paragraphs (1) through (4) by not later than 1 year
p.001005: after the date on which the first Federal capital contribution is made to the school for purposes of subsection (a);
p.001005: and
p.001005: (6) to continue carrying out such activities, and the activi- ties specified in paragraphs (1) and (2) of
p.001005: subsection (b),
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p.001005: throughout the period during which the student loan fund es- tablished pursuant to section 721(b) is in
p.001005: operation.
p.001005: (d) AVAILABILITY OF OTHER AMOUNTS.—With respect to Federal capital contributions to student loan funds
p.001005: under agreements under section 721(b), any such contributions made before October 1, 1990, together with
p.001005: the school contributions appropriate under paragraph (2)(B) of such section to the amount of the Federal cap- ital
p.001005: contributions, may be utilized for the purpose of making loans to individuals from disadvantaged backgrounds,
p.001005: subject to section 723(a)(2)(B).
p.001005: (e) DEFINITION.—For purposes of this section, the term ‘‘dis- advantaged’’, with respect to an individual,
p.001005: shall be defined by the Secretary.
p.001005: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.001005: ø(1) Repealed by section 132(b) of Public Law 105–392 (112 Stat. 3575).¿
p.001005: (2) SPECIAL CONSIDERATION FOR CERTAIN SCHOOLS.—In making Federal capital contributions to student loan
p.001005: funds for purposes of subsection (a), the Secretary shall give special con- sideration to health professions
p.001005: schools that have enrollments of underrepresented minorities above the national average for health
p.001005: professions schools.
p.001005: SEC. 725. ø292u¿ ADMINISTRATIVE PROVISIONS.
p.001005: The Secretary may agree to modifications of agreements or loans made under this subpart, and may compromise,
p.001005: waive, or re- lease any right, title, claim, or demand of the United States arising or acquired under this subpart.
p.001005: SEC. 726. ø292v¿ PROVISION BY SCHOOLS OF INFORMATION TO STU- DENTS.
p.001005: (a) IN GENERAL.—With respect to loans made by a school under this subpart after June 30, 1986, each
p.001005: school, in order to carry out the provisions of sections 721 and 722, shall, at any time such school makes such
p.001005: a loan to a student under this subpart, provide thorough and adequate loan information on loans made
p.001005: under this subpart to the student. The loan information required to be provided to the student by this
p.001005: subsection shall include—
p.001005: (1) the yearly and cumulative maximum amounts that may be borrowed by the student;
p.001005: (2) the terms under which repayment of the loan will begin;
p.001005: (3) the maximum number of years in which the loan must be repaid;
p.001005: (4) the interest rate that will be paid by the borrower and the minimum amount of the required monthly payment;
p.001005: (5) the amount of any other fees charged to the borrower by the lender;
p.001005: (6) any options the borrower may have for deferral, can- cellation, prepayment, consolidation, or other
p.001005: refinancing of the loan;
p.001005: (7) a definition of default on the loan and a specification of the consequences which will result to
p.001005: the borrower if the borrower defaults, including a description of any arrangements which may be made with credit
p.001005: bureau organizations;
p.001005: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001007: 1007
p.001007: PUBLIC HEALTH SERVICE ACT
p.001007: Sec. 728
p.001007:
p.001007: (8) to the extent practicable, the effect of accepting the loan on the eligibility of the borrower for
p.001007: other forms of stu- dent assistance; and
p.001007: (9) a description of the actions that may be taken by the Federal Government to collect the loan, including
p.001007: a description of the type of information concerning the borrower that the Federal Government may disclose to
p.001007: (A) officers, employees, or agents of the Department of Health and Human Services, (B) officers, employees,
p.001007: or agents of schools with which the Sec- retary has an agreement under this subpart, or (C) any other
p.001007: person involved in the collection of a loan under this subpart.
p.001007: (b) STATEMENT REGARDING LOAN.—Each school shall, imme- diately prior to the graduation from such school
p.001007: of a student who receives a loan under this subpart after June 30, 1986, provide such student with a
p.001007: statement specifying—
p.001007: (1) each amount borrowed by the student under this sub- part;
p.001007: (2) the total amount borrowed by the student under this subpart; and
p.001007: (3) a schedule for the repayment of the amounts borrowed under this subpart, including the number, amount, and
p.001007: fre- quency of payments to be made.
p.001007: SEC. 727. ø292w¿ PROCEDURES FOR APPEAL OF TERMINATION OF AGREEMENTS.
p.001007: In any case in which the Secretary intends to terminate an agreement with a school under this subpart,
p.001007: the Secretary shall provide the school with a written notice specifying such intention and stating that the
p.001007: school may request a formal hearing with re- spect to such termination. If the school requests such a hearing
p.001007: within 30 days after the receipt of such notice, the Secretary shall provide such school with a hearing conducted by an
p.001007: administrative law judge.
p.001007: SEC. 728. ø292x¿ DISTRIBUTION OF ASSETS FROM LOAN FUNDS.
p.001007: (a) DISTRIBUTION AFTER TERMINATION OF FUND.—If a school terminates a loan fund established under an
p.001007: agreement pursuant to section 721(b), or if the Secretary for good cause terminates the agreement with the school,
p.001007: there shall be a capital distribution as follows:
p.001007:
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p.001007: January 30, 2020
p.001007: (1) The Secretary shall first be paid an amount which bears the same ratio to such balance in such fund on the
p.001007: date of termination of the fund as the total amount of the Federal capital contributions to such fund by the
p.001007: Secretary pursuant to section 721(b)(2)(A) bears to the total amount in such fund de- rived from such Federal
p.001007: capital contributions and from funds deposited therein pursuant to section 721(b)(2)(B).
...

p.001007: allotment to the loan fund of each such school shall be reduced to whichever of the following is
p.001007: the smaller: (A) the amount requested in its application; or (B) an amount which bears the same ratio to the
p.001007: amounts appropriated as the number of stu- dents estimated by the Secretary to be enrolled in such school dur- ing such
p.001007: fiscal year bears to the estimated total number of students in all such schools during such year. Amounts
p.001007: remaining after al- lotment under the preceding sentence shall be reallotted in accord- ance with clause (B) of such
p.001007: sentence among schools whose applica- tions requested more than the amounts so allotted to their loan funds,
p.001007: but with such adjustments as may be necessary to prevent the total allotted to any such school’s loan fund
p.001007: from exceeding the total so requested by it.
p.001007: (c) ALLOTMENT OF EXCESS FUNDS.—Funds available in any fis- cal year for payment to schools under this subpart
p.001007: which are in ex- cess of the amount appropriated pursuant to this section for that year shall be allotted
p.001007: among schools in such manner as the Sec- retary determines will best carry out the purposes of this subpart.
p.001007: (d) PAYMENT OF INSTALLMENTS TO SCHOOLS.—Allotments to a loan fund of a school shall be paid to it from time to
p.001007: time in such installments as the Secretary determines will not result in unnec- essary accumulations in the
p.001007: loan fund at such school.
p.001007: (e) DISPOSITION OF FUNDS RETURNED TO SECRETARY.—
p.001007: (1) EXPENDITURE FOR FEDERAL CAPITAL CONTRIBUTIONS.— Subject to section 723(b)(5), any amounts from student
p.001007: loan funds under section 721 that are returned to the Secretary by health professions schools shall be expended
p.001007: to make Federal capital contributions to such funds.
p.001007: (2) DATE CERTAIN FOR CONTRIBUTIONS.—Amounts de- scribed in paragraph (1) that are returned to the
p.001007: Secretary shall be obligated before the end of the succeeding fiscal year.
p.001007: (3) PREFERENCE IN MAKING CONTRIBUTIONS.—In making Federal capital contributions to student loans funds under
p.001007: sec- tion 721 for a fiscal year from amounts described in paragraph (1), the Secretary shall give preference to
p.001007: health professions schools of the same disciplines as the health professions schools returning such
p.001007: amounts for the period during which the amounts expended for such contributions were received by the Secretary.
p.001007: Any such amounts that, prior to being so re- turned, were available only for the purpose of loans under this
p.001007: subpart to individuals from disadvantaged backgrounds shall be available only for such purpose.
p.001007:
p.001007:
p.001007:
p.001007:
p.001007: January 30, 2020
p.001007: 6 Title VII does not have sections 729 through 734. See section 102 of Public Law 102–408 (106 Stat.
p.001007: 1994, 2021).
p.001007: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001007:
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p.001007:
p.001009: 1009
p.001009: PUBLIC HEALTH SERVICE ACT
p.001009: Sec. 736
p.001009:
p.001009: (f) FUNDING FOR CERTAIN MEDICAL SCHOOLS.—
p.001009: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making Federal capital contributions to student
p.001009: loan funds established under section 721 by schools of medicine or osteo- pathic medicine, there is
p.001009: authorized to be appropriated
p.001009: $10,000,000 for each of the fiscal years 1994 through 1996.
p.001009: (2) MINIMUM REQUIREMENTS.—
p.001009: (A) Subject to subparagraph (B), the Secretary may make a Federal capital contribution pursuant to paragraph
p.001009: (1) only if the school of medicine or osteopathic medicine involved meets the conditions described in
p.001009: subparagraph
p.001009: (A) of section 723(b)(2) or the conditions described in sub- paragraph (C) of such section.
p.001009: (B) For purposes of subparagraph (A), the conditions referred to in such subparagraph shall be applied with re-
p.001009: spect to graduates of the school involved whose date of graduation occurred approximately 3 years before June
p.001009: 30 of the fiscal year preceding the fiscal year for which the Federal capital contribution involved is made.
p.001009:
p.001009: PART B—HEALTH PROFESSIONS TRAINING FOR DIVERSITY
p.001009: SEC. 736. ø293¿ CENTERS OF EXCELLENCE.
p.001009: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, designated health
p.001009: professions schools de- scribed in subsection (c), and other public and nonprofit health or educational
p.001009: entities, for the purpose of assisting the schools in sup- porting programs of excellence in health professions
p.001009: education for under-represented minority individuals.
p.001009: (b) REQUIRED USE OF FUNDS.—The Secretary may not make a grant under subsection (a) unless the designated health
p.001009: professions school involved agrees, subject to subsection (c)(1)(C), to expend the grant—
p.001009:
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p.001009: January 30, 2020
p.001009: (1) to develop a large competitive applicant pool through linkages with institutions of higher education, local
p.001009: school dis- tricts, and other community-based entities and establish an education pipeline for health
p.001009: professions careers;
p.001009: (2) to establish, strengthen, or expand programs to en- hance the academic performance of under-represented
p.001009: minority students attending the school;
p.001009: (3) to improve the capacity of such school to train, recruit, and retain under-represented minority faculty
p.001009: including the payment of such stipends and fellowships as the Secretary may determine appropriate;
p.001009: (4) to carry out activities to improve the information re- sources, clinical education, curricula and
p.001009: cultural competence of the graduates of the school, as it relates to minority health issues;
p.001009: (5) to facilitate faculty and student research on health issues particularly affecting
p.001009: under-represented minority groups, including research on issues relating to the delivery of health care;
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001009:
p.001009:
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p.001009:
p.001009: Sec. 736 PUBLIC HEALTH SERVICE ACT 1010
p.001009:
p.001009: (6) to carry out a program to train students of the school in providing health services to a
p.001009: significant number of under- represented minority individuals through training provided to such students at
p.001009: community-based health facilities that—
p.001009: (A) provide such health services; and
p.001009: (B) are located at a site remote from the main site of the teaching facilities of the school; and
p.001009: (7) to provide stipends as the Secretary determines appro- priate, in amounts as the Secretary determines appropriate.
p.001009: (c) CENTERS OF EXCELLENCE.—
p.001009: (1) DESIGNATED SCHOOLS.—
p.001009: (A) IN GENERAL.—The designated health professions schools referred to in subsection (a) are such schools
p.001009: that meet each of the conditions specified in subparagraphs (B) and (C), and that—
p.001009: (i) meet each of the conditions specified in para- graph (2)(A);
p.001009: (ii) meet each of the conditions specified in para- graph (3);
p.001009: (iii) meet each of the conditions specified in para- graph (4); or
...

p.001015: referred to in this section to the designated amount, or to preclude such enti- ties from competing for grants under
p.001015: this section.
p.001015: (3) MAINTENANCE OF EFFORT.—
p.001015: (A) IN GENERAL.—With respect to activities for which a grant made under this part are authorized to
p.001015: be ex- pended, the Secretary may not make such a grant to a cen- ter of excellence for any fiscal year unless
p.001015: the center agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.001015: less than the level of such expenditures maintained by the center for the fis- cal year preceding the
p.001015: fiscal year for which the school re- ceives such a grant.
p.001015: (B) USE OF FEDERAL FUNDS.—With respect to any Fed- eral amounts received by a center of excellence and
p.001015: avail- able for carrying out activities for which a grant under this part is authorized to be expended, the center
p.001015: shall, before expending the grant, expend the Federal amounts obtained from sources other than the grant, unless
p.001015: given prior ap- proval from the Secretary.
p.001015: (i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section—
p.001015: (1) $50,000,000 for each of the fiscal years 2010 through 2015; and
p.001015: (2) and such sums as are necessary for each subsequent fiscal year.
p.001015: SEC. 737. ø293a¿ SCHOLARSHIPS FOR DISADVANTAGED STUDENTS.
p.001015: (a) IN GENERAL.—The Secretary may make a grant to an eligi- ble entity (as defined in subsection (d)(1)) under this
p.001015: section for the awarding of scholarships by schools to any full-time student who is an eligible individual as
p.001015: defined in subsection (d). Such scholar-
p.001015: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001015:
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p.001015: Sec. 738 PUBLIC HEALTH SERVICE ACT 1016
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p.001015: January 30, 2020
p.001015:
p.001015: ships may be expended only for tuition expenses, other reasonable educational expenses, and reasonable living
p.001015: expenses incurred in the attendance of such school.
p.001015: (b) PREFERENCE IN PROVIDING SCHOLARSHIPS.—The Secretary may not make a grant to an entity under subsection (a)
p.001015: unless the health professions and nursing schools involved agree that, in pro- viding scholarships pursuant to the
p.001015: grant, the schools will give preference to students for whom the costs of attending the schools would constitute
...

p.001019: school or who are undertaking training necessary to qualify them to enroll in such a program;
p.001019: (F) paying such scholarships as the Secretary may de- termine for such individuals for any period of health
p.001019: pro- fessions education at a health professions school;
p.001019: (G) paying such stipends as the Secretary may ap- prove for such individuals for any period of
p.001019: education in
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001019:
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p.001019: Sec. 739 PUBLIC HEALTH SERVICE ACT 1020
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p.001019: January 30, 2020
p.001019:
p.001019: student-enhancement programs (other than regular courses), except that such a stipend may not be
p.001019: provided to an individual for more than 12 months, and such a sti- pend shall be in an amount determined appropriate by
p.001019: the Secretary (notwithstanding any other provision of law re- garding the amount of stipends);
p.001019: (H) carrying out programs under which such individ- uals gain experience regarding a career in a field
p.001019: of pri- mary health care through working at facilities of public or private nonprofit community-based providers of
p.001019: primary health services; and
p.001019: (I) conducting activities to develop a larger and more competitive applicant pool through partnerships with
p.001019: insti- tutions of higher education, school districts, and other community-based entities.
p.001019: (3) DEFINITION.—In this section, the term ‘‘regular course of education of such a school’’ as used in
p.001019: subparagraph (D) in- cludes a graduate program in behavioral or mental health.
p.001019: (b) REQUIREMENTS FOR AWARDS.—In making awards to eligible entities under subsection (a)(1), the Secretary shall give
p.001019: preference to approved applications for programs that involve a comprehensive approach by several public or
p.001019: nonprofit private health or edu- cational entities to establish, enhance and expand educational pro- grams that
p.001019: will result in the development of a competitive appli- cant pool of individuals from disadvantaged
p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
...

p.001025: of all pediatric populations with an emphasis on underserved children.
p.001025: (2) FACULTY LOAN REPAYMENT.—
p.001025: (A) IN GENERAL.—A grant or contract under subsection (a)(1)(G) may be awarded to a program of general, pedi-
p.001025: atric, or public health dentistry described in such sub- section to plan, develop, and operate a loan repayment
p.001025: pro- gram under which—
p.001025: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: 1027
p.001027: PUBLIC HEALTH SERVICE ACT
p.001027: Sec. 748
p.001027:
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p.001027: January 30, 2020
p.001027: (i) individuals agree to serve full-time as faculty members; and
p.001027: (ii) the program of general, pediatric or public health dentistry agrees to pay the principal and inter- est on
p.001027: the outstanding student loans of the individ- uals.
p.001027: (B) MANNER OF PAYMENTS.—With respect to the pay- ments described in subparagraph (A)(ii), upon completion
p.001027: by an individual of each of the first, second, third, fourth, and fifth years of service, the program
p.001027: shall pay an amount equal to 10, 15, 20, 25, and 30 percent, respec- tively, of the individual’s
p.001027: student loan balance as cal- culated based on principal and interest owed at the initi- ation of the
p.001027: agreement.
p.001027: (b) ELIGIBLE ENTITY.—For purposes of this subsection, entities eligible for such grants or contracts in general,
p.001027: pediatric, or public health dentistry shall include entities that have programs in dental or dental hygiene schools,
p.001027: or approved residency or advanced edu- cation programs in the practice of general, pediatric, or public
p.001027: health dentistry. Eligible entities may partner with schools of pub- lic health to permit the education of dental
p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
...

p.001031: nity; and
p.001031: (ii) who express a commitment to practice medi- cine in an underserved rural community.
p.001031: (3) CURRICULA.—The Program shall require students to en- roll in didactic coursework and clinical experience
p.001031: particularly applicable to medical practice in underserved rural commu- nities, including—
p.001031: (A) clinical rotations in underserved rural commu- nities, and in applicable specialties, or other
p.001031: coursework or clinical experience deemed appropriate by the Secretary; and
p.001031:
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p.001031: January 30, 2020
p.001031: (B) in addition to core school curricula, additional coursework or training experiences focused
p.001031: on medical issues prevalent in underserved rural communities.
p.001031: (4) RESIDENCY PLACEMENT ASSISTANCE.—Where available, the Program shall assist all students of the Program in
p.001031: obtain- ing clinical training experiences in locations with postgraduate
p.001031: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001033: 1033
p.001033: PUBLIC HEALTH SERVICE ACT
p.001033: Sec. 750
p.001033:
p.001033: programs offering residency training opportunities in under- served rural communities, or in local
p.001033: residency training pro- grams that support and train physicians to practice in under- served rural
p.001033: communities.
p.001033: (5) PROGRAM STUDENT COHORT SUPPORT.—The Program shall provide and require all students of the Program
p.001033: to par- ticipate in group activities designed to further develop, main- tain, and reinforce the original
p.001033: commitment of such students to practice in an underserved rural community.
p.001033: (e) ANNUAL REPORTING.—An eligible entity receiving a grant under this section shall submit an annual
p.001033: report to the Secretary on the success of the Program, based on criteria the Secretary de- termines
p.001033: appropriate, including the residency program selection of graduating students who participated in the Program.
p.001033: (f) REGULATIONS.—Not later than 60 days after the date of en- actment of this section, the Secretary shall by
p.001033: regulation define ‘‘underserved rural community’’ for purposes of this section.
p.001033: (g) SUPPLEMENT NOT SUPPLANT.—Any eligible entity receiving funds under this section shall use such funds
p.001033: to supplement, not supplant, any other Federal, State, and local funds that would oth- erwise be expended by such
p.001033: entity to carry out the activities de- scribed in this section.
p.001033: (h) MAINTENANCE OF EFFORT.—With respect to activities for which funds awarded under this section are to be
p.001033: expended, the en- tity shall agree to maintain expenditures of non-Federal amounts for such activities at a
p.001033: level that is not less than the level of such expenditures maintained by the entity for the fiscal year preceding the
p.001033: fiscal year for which the entity receives a grant under this sec- tion.
p.001033: (i) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $4,000,000 for each of the
p.001033: fiscal years 2010 through 2013.
p.001033:
p.001033: PART D—INTERDISCIPLINARY, COMMUNITY- BASED LINKAGES
p.001033:
...

p.001043: geriatric education centers may receive an award under this subsection.
p.001043: (8) MAINTENANCE OF EFFORT.—A geriatric education center that receives an award under this subsection shall provide
p.001043: as- surances to the Secretary that funds provided to the geriatric education center under this subsection
p.001043: will be used only to supplement, not to supplant, the amount of Federal, State, and local funds otherwise expended
p.001043: by the geriatric education cen- ter.
p.001043:
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p.001043: January 30, 2020
p.001043: (9) AUTHORIZATION OF APPROPRIATIONS.—In addition to any other funding available to carry out this
p.001043: section, there is authorized to be appropriated to carry out this subsection,
p.001043: $10,800,000 for the period of fiscal year 2011 through 2014.
p.001043: (e) GERIATRIC CAREER INCENTIVE AWARDS.—
p.001043: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to individuals described in
p.001043: paragraph
p.001043: (2) to foster greater interest among a variety of health profes- sionals in entering the field of
p.001043: geriatrics, long-term care, and chronic care management.
p.001043: (2) ELIGIBLE INDIVIDUALS.—To be eligible to received an award under paragraph (1), an individual shall—
p.001043: (A) be an advanced practice nurse, a clinical social worker, a pharmacist, or student of psychology who is pur-
p.001043: suing a doctorate or other advanced degree in geriatrics or
p.001043: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001043:
p.001043:
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p.001043: Sec. 754 PUBLIC HEALTH SERVICE ACT 1044
p.001043: related fields in an accredited health professions school; and
p.001043:
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p.001043: January 30, 2020
p.001043: (B) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001043: Secretary may require.
p.001043: (3) CONDITION OF AWARD.—As a condition of receiving an award under this subsection, an individual shall
p.001043: agree that, following completion of the award period, the individual will teach or practice in the field
p.001043: of geriatrics, long-term care, or chronic care management for a minimum of 5 years under guidelines set by
p.001043: the Secretary.
...

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p.001057:
p.001057: Sec. 762 PUBLIC HEALTH SERVICE ACT 1058
p.001057:
p.001057:
p.001057:
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p.001057:
p.001057:
p.001057: January 30, 2020
p.001057:
p.001057: (4) develop and publish guidelines for longitudinal evalua- tions (as described in section 761(d)(2)) for programs
p.001057: under this title, except for programs under part C or D; and
p.001057: (5) recommend appropriation levels for programs under this title, except for programs under part C or D.
p.001057: (b) COMPOSITION.—The Council shall be composed of—
p.001057: (1) the Assistant Secretary for Health or the designee of the Assistant Secretary;
p.001057: (2) the Administrator of the Health Care Financing Ad- ministration;
p.001057: (3) the Chief Medical Director of the Department of Vet- erans Affairs;
p.001057: (4) 6 members appointed by the Secretary to include rep- resentatives of practicing primary care
p.001057: physicians, national and specialty physician organizations, foreign medical grad- uates, and medical student and
p.001057: house staff associations;
p.001057: (5) 4 members appointed by the Secretary to include rep- resentatives of schools of medicine and
p.001057: osteopathic medicine and public and private teaching hospitals; and
p.001057: (6) 4 members appointed by the Secretary to include rep- resentatives of health insurers, business, and labor.
p.001057: (c) TERMS OF APPOINTED MEMBERS.—
p.001057: (1) IN GENERAL; STAGGERED ROTATION.—Members of the Council appointed under paragraphs (4), (5), and (6)
p.001057: of sub- section (b) shall be appointed for a term of 4 years, except that the term of office of the members
p.001057: first appointed shall expire, as designated by the Secretary at the time of appointment, 4 at the end
p.001057: of 1 year, 4 at the end of 2 years, 3 at the end of 3 years, and 3 at the end of 4 years.
p.001057: (2) DATE CERTAIN FOR APPOINTMENT.—The Secretary shall appoint the first members to the Council under paragraphs (4),
p.001057: (5), and (6) of subsection (b) within 60 days after the date of enactment of this section.
p.001057: (d) CHAIR.—The Council shall elect one of its members as Chairman of the Council.
p.001057: (e) QUORUM.—Nine members of the Council shall constitute a quorum, but a lesser number may hold hearings.
p.001057: (f) VACANCIES.—Any vacancy in the Council shall not affect its power to function.
p.001057: (g) COMPENSATION.—Each member of the Council who is not otherwise employed by the United States Government
p.001057: shall receive compensation at a rate equal to the daily rate prescribed for GS–
p.001057: 18 under the General Schedule under section 5332 of title 5, United States Code, for each day, including
p.001057: traveltime, such mem- ber is engaged in the actual performance of duties as a member of the Council. A member of the
...

p.001069: as de- scribed in subsection (d).
p.001069: (b) PAYMENTS.—For each year of obligated service by an indi- vidual pursuant to an agreement under
p.001069: subsection (a), the Sec- retary shall make a payment to such individual as follows:
p.001069: (1) SERVICE IN A SHORTAGE AREA.—The Secretary shall pay—
p.001069:
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p.001069: January 30, 2020
p.001069: (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1⁄6 of
p.001069: the principal of and interest on each eligible loan of the indi- vidual which is outstanding on the
p.001069: date the individual began service pursuant to the agreement; and
p.001069: (B) for completion of the sixth and final year of such service, the remainder of such principal and interest.
p.001069: (2) MAXIMUM AMOUNT.—The total amount of payments under this section to any individual shall not exceed $250,000.
p.001069: (c) ELIGIBLE LOANS.—The loans eligible for repayment under this section are each of the following:
p.001069: (1) Any loan for education or training for a substance use disorder treatment employment.
p.001069: (2) Any loan under part E of title VIII (relating to nursing student loans).
p.001069: (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or
p.001069: Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).
p.001069: (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.
p.001069: (5) Any other Federal loan as determined appropriate by the Secretary.
p.001069: (d) REQUIREMENTS OF SERVICE.—Any individual receiving pay- ments under this program as required by an agreement under
p.001069: sub- section (a) shall agree to an annual commitment to full-time em- ployment, with no more than 1
p.001069: year passing between any 2 years of covered employment, in substance use disorder treatment em- ployment
p.001069: in the United States in—
p.001069: (1) a Mental Health Professional Shortage Area, as des- ignated under section 332; or
p.001069: (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per
p.001069: 100,000 people over the past 3 years for which official data is available from the State, is higher than the
p.001069: most recent available na-
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001069:
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p.001071:
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p.001071: January 30, 2020
p.001071:
p.001071: that meet at least 4 of the criteria described in paragraph (3) shall qualify for a funding preference under
p.001071: this section.
p.001071: (2) DEFINITION.—As used in this subsection, the term ‘‘new program’’ means any program that has graduated less
p.001071: than three classes. Upon graduating at least three classes, a pro- gram shall have the capability to provide
p.001071: the information nec- essary to qualify the program for the general funding pref- erences described in
p.001071: subsection (a).
p.001071: (3) CRITERIA.—The criteria referred to in paragraph (1) are the following:
p.001071: (A) The mission statement of the program identifies a specific purpose of the program as being the preparation of
p.001071: health professionals to serve underserved populations.
p.001071: (B) The curriculum of the program includes content which will help to prepare practitioners to serve
p.001071: under- served populations.
p.001071: (C) Substantial clinical training experience is required under the program in medically underserved communities.
p.001071: (D) A minimum of 20 percent of the clinical faculty of the program spend at least 50 percent of their time
p.001071: pro- viding or supervising care in medically underserved com- munities.
p.001071: (E) The entire program or a substantial portion of the program is physically located in a medically underserved
p.001071: community.
p.001071: (F) Student assistance, which is linked to service in medically underserved communities following
p.001071: graduation, is available to the students in the program.
p.001071: (G) The program provides a placement mechanism for deploying graduates to medically underserved commu-
p.001071: nities.
p.001071: SEC. 792. ø295k¿ HEALTH PROFESSIONS DATA.
p.001071: (a) IN GENERAL.—The Secretary shall establish a program, in- cluding a uniform health professions data reporting
p.001071: system, to col- lect, compile, and analyze data on health professions personnel which program shall initially
p.001071: include data respecting all physicians and dentists in the States. The Secretary is authorized to expand the
p.001071: program to include, whenever he determines it necessary, the collection, compilation, and analysis of
p.001071: data respecting phar- macists, optometrists, podiatrists, veterinarians, public health per- sonnel, audiologists,
p.001071: speech pathologists, health care administra- tion personnel, nurses, allied health personnel, medical
p.001071: tech- nologists, chiropractors, clinical psychologists, professional coun- selors, and any other health personnel
p.001071: in States designated by the Secretary to be included in the program. Such data shall include data respecting
p.001071: the training, licensure status (including perma- nent, temporary, partial, limited, or institutional),
p.001071: place or places of practice, professional specialty, practice characteristics, place and date of birth, sex,
p.001071: and socioeconomic background of health pro- fessions personnel and such other demographic information regard- ing
p.001071: health professions personnel as the Secretary may require.
p.001071: (b) CERTAIN AUTHORITIES AND REQUIREMENTS.—
p.001071: As Amended Through P.L. 116-94, Enacted December 20, 2019
...

p.001073: participating in the program estab- lished under subsection (a). The Secretary shall determine the amount and scope
p.001073: of any such grant or contract. To be eligible for a grant or contract under this paragraph a State or entity
p.001073: shall submit an application in such form and manner and con- taining such information as the Secretary shall
p.001073: require. Such application shall include reasonable assurance, satisfactory to the Secretary, that—
p.001073: (A) such State (or nonprofit entity within a State) will establish a program of mandatory annual registration of
p.001073: the health professions personnel described in subsection
p.001073: (a) who reside or practice in such State and of health insti- tutions licensed by such State, which registration shall
p.001073: in- clude such information as the Secretary shall determine to be appropriate;
p.001073: (B) such State or entity shall collect such information and report it to the Secretary in such form and manner
p.001073: as the Secretary shall prescribe; and
p.001073: (C) such State or entity shall comply with the require- ments of subsection (e).
p.001073: (d) 17 REPORTS TO CONGRESS.—The Secretary shall submit to the Congress on October 1, 1993, and biennially
p.001073: thereafter, the fol- lowing reports:
p.001073: (1) A comprehensive report regarding the status of health personnel according to profession, including a report
p.001073: regarding the analytic and descriptive studies conducted under this sec- tion.
p.001073: (2) A comprehensive report regarding applicants to, and students enrolled in, programs and institutions for the
p.001073: training of health personnel, including descriptions and analyses of stu- dent indebtedness, student need for financial
p.001073: assistance, finan-
p.001073:
p.001073:
p.001073:
p.001073: January 30, 2020
p.001073: 17 So in law. Probably should be redesignated as (c).
p.001073: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001073:
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p.001073: Sec. 792 PUBLIC HEALTH SERVICE ACT 1074
p.001073:
p.001073: cial resources to meet the needs of students, student career choices such as practice specialty and
p.001073: geographic location and the relationship, if any, between student indebtedness and ca- reer choices.
p.001073: (e) 18 REQUIREMENTS REGARDING PERSONAL DATA.—
p.001073: (1) IN GENERAL.—The Secretary and each program entity shall in securing and maintaining any record of
p.001073: individually identifiable personal data (hereinafter in this subsection re- ferred to as ‘‘personal data’’) for
p.001073: purposes of this section—
p.001073: (A) inform any individual who is asked to supply per- sonal data whether he is legally required, or may
p.001073: refuse, to supply such data and inform him of any specific con- sequences, known to the Secretary or
p.001073: program entity, as the case may be, of providing or not providing such data;
p.001073: (B) upon request, inform any individual if he is the subject of personal data secured or maintained by the
p.001073: Sec- retary or program entity, as the case may be, and make the data available to him in a form
p.001073: comprehensible to him;
p.001073: (C) assure that no use is made of personal data which use is not within the purposes of this section unless an in-
p.001073: formed consent has been obtained from the individual who is the subject of such data; and
p.001073: (D) upon request, inform any individual of the use being made of personal data respecting such
p.001073: individual and of the identity of the individuals and entities which will use the data and their
p.001073: relationship to the programs under this section.
p.001073: (2) CONSENT AS PRECONDITION TO DISCLOSURE.—Any entity which maintains a record of personal data and which
p.001073: receives a request from the Secretary or a program entity for such data for purposes of this section shall not transfer
...

p.001079: eligible for accreditation by such a recog- nized body or bodies, shall be deemed accredited for purposes of
p.001079: this title, if the Secretary of Education finds, after consulta- tion with the appropriate accreditation body or
p.001079: bodies, that there is reasonable assurance that the school or program will meet the accreditation
p.001079: standards of such body or bodies prior to the beginning of the academic year following the normal
p.001079: graduation date of the first entering class in such school or program.
p.001079:
p.001079:
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p.001079:
p.001079: January 30, 2020
p.001079: 24 Section 108(a)(2) of Public Law 105–392 (112 Stat. 3560) provides that paragraph (1)(D) is amended by inserting
p.001079: ‘‘behavioral health and mental health practice,’’ before ‘‘clinical’’. The amendment cannot be executed
p.001079: because the amendment does not specify to which instance of the term ‘‘clinical’’ the amendment applies.
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001079:
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p.001079: Sec. 799B PUBLIC HEALTH SERVICE ACT 1080
p.001079:
p.001079: (2) The term ‘‘teaching facilities’’ means areas dedicated for use by students, faculty, or administrative
p.001079: or maintenance personnel for clinical purposes, research activities, libraries, classrooms, offices,
p.001079: auditoriums, dining areas, student activi- ties, or other related purposes necessary for, and appropriate
p.001079: to, the conduct of comprehensive programs of education. Such term includes interim facilities but does not
p.001079: include off-site im- provements or living quarters.
p.001079: (3) PHYSICIAN ASSISTANT EDUCATION PROGRAM.—The term ‘‘physician assistant education program’’ means an educational
p.001079: program in a public or private institution in a State that—
p.001079: (A) has as its objective the education of individuals who, upon completion of their studies in the
p.001079: program, be qualified to provide primary care medical services with the supervision of a physician; and
p.001079: (B) is accredited by the Accreditation Review Commis- sion on Education for the Physician Assistant.
p.001079: (4) The term ‘‘school of allied health’’ means a public or nonprofit private college, junior college, or
p.001079: university or hos- pital-based educational entity that—
p.001079: (A) provides, or can provide, programs of education to enable individuals to become allied health professionals or to
p.001079: provide additional training for allied health profes- sionals;
p.001079: (B) provides training for not less than a total of twenty persons in the allied health curricula (except that this sub-
p.001079: paragraph shall not apply to any hospital-based edu- cational entity);
...

p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
p.001089: the costs of special projects to increase nursing education opportunities for individuals who are from
p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
p.001089:
p.001089:
p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001089:
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p.001091: 1091
p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
p.001091: Islander Nurses, the Native American Indian and Alas- kan Nurses Association, and the National Council of State
p.001091: Boards of Nursing, and other organizations determined appropriate by the Secretary.
p.001091: (c) REQUIRED INFORMATION AND CONDITIONS FOR AWARD RE-
p.001091: CIPIENTS.—
...

p.001093: the Secretary measurable and substantive improvement in nurse retention or patient care.
p.001093: (d) OTHER PRIORITY AREAS.—The Secretary may award grants to, or enter into contracts with, eligible entities
p.001093: to address other
p.001093:
p.001093:
p.001093:
p.001093: January 30, 2020
p.001093: 2 So in law.
p.001093:
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p.001093:
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p.001093: Sec. 835 PUBLIC HEALTH SERVICE ACT 1094
p.001093:
p.001093: areas that are of high priority to nurse retention, as determined by the Secretary.
p.001093: (e) REPORT.—The Secretary shall submit to the Congress be- fore the end of each fiscal year a report on the
p.001093: grants awarded and the contracts entered into under this section. Each such report shall identify the overall
p.001093: number of such grants and contracts and provide an explanation of why each such grant or contract will meet
p.001093: the priority need of the nursing workforce.
p.001093: (f) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ includes an accredited school
p.001093: of nursing, as defined by section 801(2), a health care facility, or a partnership of such a school and
p.001093: facility.
p.001093: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001093: sums as may be necessary for each of fiscal years 2010 through 2012.
p.001093: PART E—STUDENT LOANS 3
p.001093: LOAN AGREEMENTS
p.001093: SEC. 835. ø297a¿ (a) The Secretary is authorized to enter into an agreement for the establishment and operation of a
p.001093: student loan fund in accordance with this part with any public or nonprofit pri- vate school of nursing which is
p.001093: located in a State.
p.001093: (b) Each agreement entered into under this section shall—
p.001093: (1) provide for establishment of a student loan fund by the school;
p.001093: (2) provide for deposit in the fund, except as provided in section 871, of (A) the Federal capital
p.001093: contributions paid from allotments under section 838 to the school by the Secretary, (B) an additional amount from
p.001093: other sources equal to not less than one-ninth of such Federal capital contributions, (C) collections of
p.001093: principal and interest on loans made from the fund, (D) col- lections pursuant to section 836(f), and (E) any other
p.001093: earnings of the fund;
p.001093: (3) provide that the fund, except as provided in section 871, shall be used only for loans to students
p.001093: of the school in accordance with the agreement and for costs of collection of such loans and interest
p.001093: thereon;
p.001093: (4) provide that loans may be made from such fund only to students pursuing a full-time or half-time course
p.001093: of study at the school leading to a baccalaureate or associate degree in nursing or an equivalent degree or a
p.001093: diploma in nursing, or to a graduate degree in nursing; and
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p.001093: January 30, 2020
p.001093: 3 Section 936(e) of Public Law 94–63 repealed a section of this title that provided for a revolv- ing fund. This former
p.001093: section was section 827. With respect to the revolving fund, such section 936(e) provided as follows: ‘‘The nurse
p.001093: training fund created within the Treasury by section 827(d)(1) of the Act shall remain available to the
p.001093: Secretary of Health, Education, and Welfare for the purpose of meeting his responsibilities respecting
p.001093: participations in obligations acquired under section 827 of the Act. The Secretary shall continue to deposit in such
p.001093: fund all amounts received by him as interest payments or repayments of principal on loans under such
p.001093: section 827. If at any time the Secretary determines the moneys in the funds exceed the present and any
p.001093: reasonable prospective further requirements of such fund, such excess may be transferred to the general
p.001093: fund of the Treasury.’’. Such section further provided that ‘‘[t]here are authorized to be appropriated without
p.001093: fiscal year limitation such sums as may be necessary to enable the Secretary to make payments under
p.001093: agreements entered into under section 827(b) of the Act be- fore øJuly 27, 1975¿’’.
p.001093: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001095: 1095
p.001095: PUBLIC HEALTH SERVICE ACT
p.001095: Sec. 836
p.001095:
p.001095: (5) contain such other provisions as are necessary to pro- tect the financial interests of the United States.
p.001095: (c)(1) Any standard established by the Secretary by regulation for the collection by schools of nursing of
p.001095: loans made pursuant to loan agreements under this part shall provide that the failure of any such school
p.001095: to collect such loans shall be measured in accord- ance with this subsection. With respect to the student loan
p.001095: fund es- tablished pursuant to such agreements, this subsection may not be construed to require such schools to
p.001095: reimburse such loan fund for loans that became uncollectable prior to 1983.
p.001095: (2) The measurement of a school’s failure to collect loans made under this part shall be the ratio (stated as a
p.001095: percentage) that the defaulted principal amount outstanding of such school bears to the matured loans of such school.
p.001095: (3) For purposes of this subsection—
p.001095: (A) the term ‘‘default’’ means the failure of a borrower of a loan made under this part to—
p.001095: (i) make an installment payment when due; or
p.001095: (ii) comply with any other term of the promissory note for such loan,
p.001095: except that a loan made under this part shall not be considered to be in default if the loan is discharged in
p.001095: bankruptcy or if the school reasonably concludes from written contacts with the borrower that the borrower intends to
p.001095: repay the loan;
p.001095: (B) the term ‘‘defaulted principal amount outstanding’’ means the total amount borrowed from the
p.001095: loan fund of a school that has reached the repayment stage (minus any prin- cipal amount repaid or cancelled) on
p.001095: loans—
p.001095: (i) repayable monthly and in default for at least 120 days; and
p.001095: (ii) repayable less frequently than monthly and in de- fault for at least 180 days;
p.001095: (C) the term ‘‘grace period’’ means the period of nine months beginning on the date on which the borrower
p.001095: ceases to pursue a full-time or half-time course of study at a school of nursing; and
p.001095: (D) the term ‘‘matured loans’’ means the total principal amount of all loans made by a school of
p.001095: nursing under this part minus the total principal amount of loans made by such school to students who are—
p.001095: (i) enrolled in a full-time or half-time course of study at such school; or
p.001095: (ii) in their grace period.
p.001095:
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p.001095: January 30, 2020
p.001095:
p.001095: LOAN PROVISIONS
p.001095: SEC. 836. ø297b¿ (a) The total of the loans for any academic year (or its equivalent, as determined under
p.001095: regulations of the Sec- retary) made by schools of nursing from loan funds established pur- suant to agreements under
p.001095: this part may not exceed $3,300 in the case of any student, except that for the final two academic years of
p.001095: the program involved, such total may not exceed $5,200. The ag- gregate of the loans for all years from such
p.001095: funds may not exceed
p.001095: $17,000 in the case of any student during fiscal years 2010 and
p.001095: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001095: Sec. 836 PUBLIC HEALTH SERVICE ACT 1096
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p.001095: January 30, 2020
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p.001095: 2011. After fiscal year 2011, such amounts shall be adjusted to pro- vide for a cost-of-attendance increase for
p.001095: the yearly loan rate and the aggregate of the loans.
p.001095: (b) Loans from any such student loan fund by any school shall be made on such terms and conditions as the
p.001095: school may deter- mine; subject, however, to such conditions, limitations, and require- ments as the Secretary
p.001095: may prescribe (by regulation or in the agreement with the school) with a view to preventing impairment
p.001095: of the capital of such fund to the maximum extent practicable in the light of the objective of
p.001095: enabling the student to complete his course of study; and except that—
p.001095: (1) such a loan may be made only to a student who (A) is in need of the amount of the loan to pursue a full-time or
p.001095: half- time course of study at the school leading to a baccalaureate or associate degree in nursing or an
p.001095: equivalent degree, or a di- ploma in nursing, or a graduate degree in nursing, (B) is capa- ble, in the opinion of the
p.001095: school, of maintaining good standing in such course of study, and (C) with respect to any student en- rolling in the
p.001095: school after June 30, 2000, is of financial need (as defined in regulations issued by the Secretary);
p.001095: (2) such a loan shall be repayable in equal or graduated periodic installments (with the right of the
p.001095: borrower to accel- erate repayment) over the ten-year period which begins nine months after the student
p.001095: ceases to pursue a full-time or half- time course of study at a school of nursing, excluding from such
p.001095: 10-year period all (A) periods (up to three years) of (i) ac- tive duty performed by the borrower as a member
p.001095: of a uni- formed service, or (ii) service as a volunteer under the Peace Corps Act, (B) periods (up to ten
p.001095: years) during which the bor- rower is pursuing a full-time or half-time course of study at a collegiate school of
p.001095: nursing leading to baccalaureate degree in nursing or an equivalent degree, or to graduate degree in nurs- ing, or
p.001095: is otherwise pursuing advanced professional training in nursing (or training to be a nurse anesthetist), and
p.001095: (C) such additional periods under the terms of paragraph (8) of this sub- section;
p.001095: (3) in the case of a student who received such a loan before September 29, 1995, an amount up to 85 per centum
p.001095: of any such loan made before such date (plus interest thereon) shall be canceled for full-time
p.001095: employment as a professional nurse (including teaching in any of the fields of nurse training and service
p.001095: as an administrator, supervisor, or consultant in any of the fields of nursing) in any public or nonprofit private
p.001095: agency, institution, or organization (including neighborhood health cen- ters), at the rate of 15 per centum of the
p.001095: amount of such loan (plus interest) unpaid on the first day of such service for each of the first, second, and
p.001095: third complete year of such service, and 20 per centum of such amount (plus interest) for each com- plete fourth
p.001095: and fifth year of such service;
p.001095: (4) the liability to repay the unpaid balance of such loan and accrued interest thereon shall be canceled
p.001095: upon the death of the borrower, or if the Secretary determines that he has be- come permanently and totally disabled;
p.001095: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001097: 1097
p.001097: PUBLIC HEALTH SERVICE ACT
p.001097: Sec. 836
p.001097:
p.001097:
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p.001097: January 30, 2020
p.001097: (5) such a loan shall bear interest on the unpaid balance of the loan, computed only for periods
p.001097: during which the loan is repayable, at the rate of 5 percent per annum;
p.001097: (6) such a loan shall be made without security or endorse- ment, except that if the borrower is a minor and
p.001097: the note or other evidence of obligation executed by him would not, under the applicable law, create a binding
p.001097: obligation, either security or endorsement may be required;
p.001097: (7) no note or other evidence of any such loan may be transferred or assigned by the school making
p.001097: the loan except that, if the borrower transfers to another school participating in the program under this
p.001097: part, such note or other evidence of a loan may be transferred to such other school; and
p.001097: (8) pursuant to uniform criteria established by the Sec- retary, the repayment period established under
p.001097: paragraph (2) for any student borrower who during the repayment period failed to make consecutive payments and
p.001097: who, during the last 12 months of the repayment period, has made at least 12 con- secutive payments may be extended for
p.001097: a period not to exceed 10 years.
p.001097: (c) Where all or any part of a loan, or interest, is canceled under this section, the Secretary shall pay
p.001097: to the school an amount equal to the school’s proportionate share of the canceled portion, as determined by the
p.001097: Secretary.
p.001097: (d) Any loan for any year by a school from a student loan fund established pursuant to an agreement under this
p.001097: part shall be made in such installments as may be provided in regulations of the Secretary or such agreement and,
p.001097: upon notice to the Secretary by the school that any recipient of a loan is failing to maintain satis- factory
p.001097: standing, any or all further installments of his loans shall be withheld, as may be appropriate.
p.001097: (e) An agreement under this part with any school shall include provisions designed to make loans from the
p.001097: student loan fund es- tablished thereunder reasonably available (to the extent of the available funds in
p.001097: such fund) to all eligible students in the school in need thereof.
p.001097: (f) Subject to regulations of the Secretary and in accordance with this section, a school shall assess
p.001097: a charge with respect to a loan from the loan fund established pursuant to an agreement under this part
p.001097: for failure of the borrower to pay all or any part of an installment when it is due and, in the case of a
p.001097: borrower who is entitled to deferment of the loan under subsection (b)(2) or can- cellation of part or all of the
p.001097: loan under subsection (b)(3), for any failure to file timely and satisfactory evidence of such entitlement. No
p.001097: such charge may be made if the payment of such installment or the filing of such evidence is made within 60
p.001097: days after the date on which such installment or filing is due. The amount of any such charge may not exceed an amount
p.001097: equal to 6 percent of the amount of such installment. The school may elect to add the amount of any such charge to the
p.001097: principal amount of the loan as of the first day after the day on which such installment or evidence was due, or to
p.001097: make the amount of the charge payable to the school not later than the due date of the next installment after
p.001097: receipt by the borrower of notice of the assessment of the charge.
p.001097: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001097: effect); and
p.001097: (B) in the case of any person who obtained one or more loans from a loan fund established under this part
p.001097: and who on such date was engaged in a service for which cancellation of all or part of such loans
p.001097: (including accrued interest) was au- thorized under this section (as so in effect), this section (as so in effect)
p.001097: shall continue to apply to such person for purposes of providing such loan cancellation until he
p.001097: terminates such service.
p.001097: (i) Upon application by a person who received and is under an obligation to repay, any loan made to such person as a
p.001097: nursing stu- dent, the Secretary may undertake to repay (without liability to the applicant) all or any part of such
p.001097: loan, and any interest or portion thereof outstanding thereon, upon his determination, pursuant to regulations
p.001097: establishing criteria therefor, that the applicant—
p.001097: (1) failed to complete the nursing studies with respect to which such loan was made;
p.001097: (2) is in exceptionally needy circumstances; and
p.001097: (3) has not resumed, or cannot reasonably be expected to resume, such nursing studies within two years
p.001097: following the date upon which the applicant terminated the studies with re- spect to which such loan was made.
p.001097: (j) The Secretary is authorized to attempt to collect any loan which was made under this part, which
p.001097: is in default, and which was referred to the Secretary by a school of nursing with which the Secretary has an
p.001097: agreement under this part, on behalf of that school under such terms and conditions as the Secretary may pre-
p.001097: scribe (including reimbursement from the school’s student loan fund for expenses the Secretary may
p.001097: reasonably incur in attempt- ing collection), but only if the school has complied with such re-
p.001097: quirements as the Secretary may specify by regulation with respect to the collection of loans under this part.
p.001097: A loan so referred shall be treated as a debt subject to section 5514 of title 5, United States Code. Amounts
p.001097: collected shall be deposited in the school’s student loan fund. Whenever the Secretary desires the institution
p.001097: of a civil action regarding any such loan, the Secretary shall refer the mat- ter to the Attorney General for
p.001097: appropriate action.
p.001097: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001099: 1099
p.001099: PUBLIC HEALTH SERVICE ACT
p.001099: Sec. 838
p.001099:
p.001099: (k) 4 ELIMINATION OF STATUTE OF LIMITATION FOR LOAN COL-
p.001099: LECTIONS.—
p.001099: (1) PURPOSE.—It is the purpose of this subsection to en- sure that obligations to repay loans under this
p.001099: section are en- forced without regard to any Federal or State statutory, regu- latory, or administrative
p.001099: limitation on the period within which debts may be enforced.
p.001099: (2) PROHIBITION.—Notwithstanding any other provision of Federal or State law, no limitation shall terminate
p.001099: the period within which suit may be filed, a judgment may be enforced, or an offset, garnishment, or
p.001099: other action may be initiated or taken by a school of nursing that has an agreement with the Secretary
p.001099: pursuant to section 835 that is seeking the repay- ment of the amount due from a borrower on a loan made under
p.001099: this part after the default of the borrower on such loan.
p.001099:
p.001099: ALLOTMENTS AND PAYMENTS OF FEDERAL CAPITAL CONTRIBUTIONS
p.001099: SEC. 838. 5 ø297d¿ (a)(1) The Secretary shall from time to time set dates by which schools of nursing in a State must
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p.001101:
p.001101: (c) PAYMENT BY DUE DATE.—Notwithstanding the requirement of completion of practice specified in subsection
p.001101: (b), the Secretary shall, on or before the due date thereof, pay any loan or loan in- stallment which
p.001101: may fall due within the period of service for which the borrower may receive payments under this subsection,
p.001101: upon the declaration of such borrower, at such times and in such manner as the Secretary may prescribe (and
p.001101: supported by such other evi- dence as the Secretary may reasonably require), that the borrower is then serving as
p.001101: described by subsection (a)(3), and that the bor- rower will continue to so serve for the period required (in
p.001101: the ab- sence of this subsection) to entitle the borrower to have made the payments provided by this
p.001101: subsection for such period; except that not more than 85 percent of the principal of any such loan
p.001101: shall be paid pursuant to this subsection.
p.001101: (d) SCHOLARSHIP PROGRAM.—
p.001101: (1) IN GENERAL.—The Secretary shall (for fiscal years 2003 and 2004) and may (for fiscal years thereafter) carry out a
p.001101: pro- gram of entering into contracts with eligible individuals under which such individuals agree to serve as nurses
p.001101: for a period of not less than 2 years at a health care facility with a critical shortage of nurses, in
p.001101: consideration of the Federal Government agreeing to provide to the individuals scholarships for attend- ance at
p.001101: schools of nursing.
p.001101: (2) ELIGIBLE INDIVIDUALS.—In this subsection, the term ‘‘eligible individual’’ means an individual who is
p.001101: enrolled or ac- cepted for enrollment as a full-time or part-time student in a school of nursing.
p.001101: (3) SERVICE REQUIREMENT.—
p.001101: (A) IN GENERAL.—The Secretary may not enter into a contract with an eligible individual under this
p.001101: subsection unless the individual agrees to serve as a nurse at a health care facility with a critical
p.001101: shortage of nurses for a period of full-time service of not less than 2 years, or for a period of
p.001101: part-time service in accordance with subpara- graph (B).
p.001101: (B) PART-TIME SERVICE.—An individual may complete the period of service described in subparagraph (A) on
p.001101: a part-time basis if the individual has a written agreement that—
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p.001101: (i) is entered into by the facility and the indi- vidual and is approved by the Secretary; and
p.001101: (ii) provides that the period of obligated service will be extended so that the aggregate amount of serv- ice
p.001101: performed will equal the amount of service that would be performed through a period of full-time serv- ice of
p.001101: not less than 2 years.
p.001101: (4) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of subpart III of part D of title III shall, except as
p.001101: inconsistent with this section, apply to the program established in para- graph (1) in the same manner and to
p.001101: the same extent as such provisions apply to the National Health Service Corps Scholar- ship Program established in such
p.001101: subpart.
p.001101: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001103: (4) which educational institution the recipients attended;
p.001103: (5) the number and placement location of the scholarship and loan repayment recipients at health care
p.001103: facilities with a critical shortage of nurses;
p.001103: (6) the default rate and actions required;
p.001103: (7) the amount of outstanding default funds of both the scholarship and loan repayment programs;
p.001103: (8) to the extent that it can be determined, the reason for the default;
p.001103: (9) the demographics of the individuals participating in the scholarship and loan repayment programs;
p.001103: (10) justification for the allocation of funds between the scholarship and loan repayment programs; and
p.001103: (11) an evaluation of the overall costs and benefits of the programs.
p.001103: (i) FUNDING.—
p.001103: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of payments under agreements entered into under
p.001103: subsection
p.001103: (a) or (d), there are authorized to be appropriated such sums as may be necessary for each of fiscal years
p.001103: 2003 through 2007.
p.001103: (2) ALLOCATIONS.—Of the amounts appropriated under paragraph (1), the Secretary may, as determined
p.001103: appropriate by the Secretary, allocate amounts between the program under subsection (a) and the program under
p.001103: subsection (d).
p.001103:
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p.001103: January 30, 2020
p.001103: NURSE FACULTY LOAN PROGRAM
p.001103: SEC. 846A. ø297n–1¿ (a) SCHOOL OF NURSING STUDENT LOAN
p.001103: FUND.—The Secretary, acting through the Administrator of the Health Resources and Services Administration,
p.001103: may enter into an agreement with any accredited school of nursing for the establish- ment and operation of
p.001103: a student loan fund in accordance with this section, to increase the number of qualified nursing faculty.
p.001103: (b) AGREEMENTS.—Each agreement entered into under sub- section (a) shall—
p.001103: (1) provide for the establishment of a student loan fund by the school involved;
p.001103: (2) provide for deposit in the fund of—
p.001103: (A) the Federal capital contributions to the fund;
p.001103: (B) an amount equal to not less than one-ninth of such Federal capital contributions, contributed by such school;
p.001103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001105: 1105
p.001105: PUBLIC HEALTH SERVICE ACT
p.001105: Sec. 846A
p.001105:
p.001105: (C) collections of principal and interest on loans made from the fund; and
p.001105: (D) any other earnings of the fund;
p.001105: (3) provide that the fund will be used only for loans to stu- dents of the school in accordance with subsection
p.001105: (c) and for costs of collection of such loans and interest thereon;
p.001105: (4) provide that loans may be made from such fund only to students pursuing a full-time course of study or,
p.001105: at the dis- cretion of the Secretary, a part-time course of study in an ad- vanced degree program described
p.001105: in section 811(b); and
p.001105: (5) contain such other provisions as are necessary to pro- tect the financial interests of the United States.
p.001105: (c) LOAN PROVISIONS.—Loans from any student loan fund es- tablished by a school pursuant to an agreement
p.001105: under subsection
p.001105: (a) shall be made to an individual on such terms and conditions as the school may determine, except that—
p.001105: (1) such terms and conditions are subject to any condi- tions, limitations, and requirements prescribed
p.001105: by the Sec- retary;
p.001105: (2) in the case of any individual, the total of the loans for any academic year made by schools of nursing from loan
p.001105: funds established pursuant to agreements under subsection (a) may not exceed $35,500, during fiscal years
p.001105: 2010 and 2011 fiscal years (after fiscal year 2011, such amounts shall be adjusted to provide for a
p.001105: cost-of-attendance increase for the yearly loan rate and the aggregate loan;
p.001105: (3) an amount up to 85 percent of any such loan (plus in- terest thereon) shall be canceled by the school as follows:
p.001105: (A) upon completion by the individual of each of the first, second, and third year of full-time
p.001105: employment, re- quired by the loan agreement entered into under this sub- section, as a faculty member in an
p.001105: accredited a 11 school of nursing, the school shall cancel 20 percent of the principle of, and the interest on, the
p.001105: amount of such loan unpaid on the first day of such employment; and
p.001105: (B) upon completion by the individual of the fourth year of full-time employment, required by the loan
p.001105: agree- ment entered into under this subsection, as a faculty mem- ber in a school of nursing, the school shall
p.001105: cancel 25 per- cent of the principle of, and the interest on, the amount of such loan unpaid on the first day of such
p.001105: employment;
p.001105: (4) such a loan may be used to pay the cost of tuition, fees, books, laboratory expenses, and other reasonable
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p.001105: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001105: Sec. 847 PUBLIC HEALTH SERVICE ACT 1106
p.001105:
p.001105: (A) beginning on the date that is 3 months after the individual ceases to pursue a course of study at
p.001105: a school of nursing, bear interest on the unpaid balance of the loan at the rate of 3 percent per annum; or
p.001105: (B) subject to subsection (e), if the school of nursing determines that the individual will not
p.001105: complete such course of study or serve as a faculty member as required under the loan agreement under
p.001105: this subsection, bear in- terest on the unpaid balance of the loan at the prevailing market rate.
p.001105: (d) PAYMENT OF PROPORTIONATE SHARE.—Where all or any part of a loan, or interest, is canceled under
p.001105: this section, the Sec- retary shall pay to the school an amount equal to the school’s pro- portionate share of the
p.001105: canceled portion, as determined by the Sec- retary.
p.001105: (e) REVIEW BY SECRETARY.—At the request of the individual in- volved, the Secretary may review any determination by an
p.001105: accred- ited school of nursing under subsection (c)(6)(B).
p.001105: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001105: such sums as may be necessary for each of fiscal years 2010 through 2014.
p.001105: SEC. 847. ø297o¿ ELIGIBLE INDIVIDUAL STUDENT LOAN REPAYMENT.
p.001105: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001105: Administration, may enter into an agreement with eligible individuals for the repayment of education loans, in
p.001105: accordance with this section, to increase the number of qualified nursing faculty.
p.001105: (b) AGREEMENTS.—Each agreement entered into under this subsection shall require that the eligible
p.001105: individual shall serve as a full-time member of the faculty of an accredited school of nursing, for a total
p.001105: period, in the aggregate, of at least 4 years during the 6-year period beginning on the later of—
p.001105: (1) the date on which the individual receives a master’s or doctorate nursing degree from an accredited school of
p.001105: nursing; or
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p.001105: (2) the date on which the individual enters into an agree- ment under this subsection.
p.001105: (c) AGREEMENT PROVISIONS.—Agreements entered into pursu- ant to subsection (b) shall be entered into on such
p.001105: terms and condi- tions as the Secretary may determine, except that—
p.001105: (1) not more than 10 months after the date on which the 6-year period described under subsection (b)
p.001105: begins, but in no case before the individual starts as a full-time member of the faculty of an
p.001105: accredited school of nursing the Secretary shall begin making payments, for and on behalf of that
...

p.001107: compliance by the individual with the agreement involved is impossible or would involve ex- treme hardship to the
p.001107: individual or if enforcement of the agree- ment with respect to the individual would be unconscionable.
p.001107: (3) DATE CERTAIN FOR RECOVERY.—Subject to paragraph (2), any amount that the Federal Government is entitled
p.001107: to re- cover under paragraph (1) shall be paid to the United States not later than the expiration of the
p.001107: 3-year period beginning on the date the United States becomes so entitled.
p.001107: (4) AVAILABILITY.—Amounts recovered under paragraph (1) shall be available to the Secretary for making loan repayments
p.001107: under this section and shall remain available for such purpose until expended.
p.001107: (e) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this sec- tion, the term ‘‘eligible individual’’ means an
p.001107: individual who—
p.001107: (1) is a United States citizen, national, or lawful perma- nent resident;
p.001107: (2) holds an unencumbered license as a registered nurse;
p.001107: and
p.001107: (3) has either already completed a master’s or doctorate
p.001107:
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p.001107: January 30, 2020
p.001107: nursing program at an accredited school of nursing or is cur- rently enrolled on a full-time or part-time
p.001107: basis in such a pro- gram.
p.001107: (f) PRIORITY.—For the purposes of this section and section 846A, funding priority will be awarded to
p.001107: School of Nursing Stu- dent Loans that support doctoral nursing students or Individual Student Loan
p.001107: Repayment that support doctoral nursing students.
p.001107: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001107: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001107: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001107:
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p.001107:
p.001107: Sec. 851 PUBLIC HEALTH SERVICE ACT 1108
p.001107:
p.001107: PART F—NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE
p.001107:
p.001107: SEC. 851. ø297t¿ NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE.
p.001107: (a) ESTABLISHMENT.—The Secretary shall establish an advisory council to be known as the National Advisory
p.001107: Council on Nurse Education and Practice (in this section referred to as the ‘‘Advisory Council’’).
p.001107: (b) COMPOSITION.—
p.001107: (1) IN GENERAL.—The Advisory Council shall be composed
p.001107:
p.001107: of—
p.001107:
p.001107: (A) not less than 21, nor more than 23 individuals, who are not officers or employees of the Federal
p.001107: Govern- ment, appointed by the Secretary without regard to the Federal civil service laws, of which—
p.001107: (i) 2 shall be selected from full-time students en- rolled in schools of nursing;
p.001107: (ii) 2 shall be selected from the general public;
...

p.001213: those prescribed by or under this title, basic and supplemental health services to its mem- bers in the following
p.001213: manner:
p.001213: (1) Each member is to be provided basic health services for a basic health services payment which (A) is to be
p.001213: paid on a periodic basis without regard to the dates health services (within the basic health
p.001213: services) are provided; (B) is fixed without regard to the frequency, extent, or kind of health serv-
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001215: 1215
p.001215: PUBLIC HEALTH SERVICE ACT
p.001215: Sec. 1301
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p.001215: ice (within the basic health services) actually furnished; (C) ex- cept in the case of basic health services
p.001215: provided a member who is a full-time student (as defined by the Secretary) at an accredited institution of
p.001215: higher education, is fixed under a com- munity rating system; and (D) may be supplemented by addi- tional
p.001215: nominal payments which may be required for the provi- sion of specific services (within the basic health
p.001215: services), ex- cept that such payments may not be required where or in such a manner that they serve (as determined
p.001215: under regulations of the Secretary) as a barrier to the delivery of health services. Such additional nominal
p.001215: payments shall be fixed in accordance with the regulations of the Secretary. If a health maintenance organization
p.001215: offers to its members the opportunity to obtain basic health services through a physician not described in sub-
p.001215: section (b)(3)(A), the organization may require, in addition to payments described in clause (D) of this
p.001215: paragraph, a reason- able deductible to be paid by a member when obtaining a basic health service from such a
p.001215: physician. A health maintenance or- ganization may include a health service, defined as a supple- mental
p.001215: health service by section 1302(2), in the basic health services provided its members for a basic health
p.001215: services pay- ment described in the first sentence. In the case of an entity which before it became a
p.001215: qualified health maintenance organi- zation (within the meaning of section 1310(d)) provided com- prehensive
p.001215: health services on a prepaid basis, the requirement of clause (C) shall not apply to such entity until the expiration
p.001215: of the forty-eight month period beginning with the month fol- lowing the month in which the entity became such
...

p.001215: referred to as ‘‘supplemental health services payments’’) as the health maintenance organization may require in
p.001215: addition to the basic health services payment, the organization may pro- vide to each of its members any
p.001215: of the health services which
p.001215: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001215:
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p.001215: Sec. 1301 PUBLIC HEALTH SERVICE ACT 1216
p.001215:
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p.001215: are included in supplemental health services (as defined in sec- tion 1302(2)). Supplemental health services
p.001215: payments which are fixed on a prepayment basis shall be fixed under a commu- nity rating system unless the
p.001215: supplemental health services payment is for a supplemental health service provided a mem- ber who is a full-time
p.001215: student (as defined by the Secretary) at an accredited institution of higher education, except that, in the
p.001215: case of an entity which before it became a qualified health maintenance organization (within the meaning of
p.001215: section 1310(d)) provided comprehensive health services on a prepaid basis, the requirement of this sentence
p.001215: shall not apply to such entity during the forty-eight month period beginning with the month following the month
p.001215: in which the entity became such a qualified health maintenance organization.
p.001215: (3)(A) Except as provided in subparagraph (B), at least 90 percent of the services of a physician which are
p.001215: provided as basic health services shall be provided through—
p.001215: (i) members of the staff of the health maintenance or- ganization,
p.001215: (ii) a medical group (or groups),
p.001215: (iii) an individual practice association (or associations),
p.001215: (iv) physicians or other health professionals who have contracted with the health maintenance organization for
p.001215: the provision of such services, or
p.001215: (v) any combination of such staff, medical group (or groups), individual practice association (or associations)
p.001215: or physicians or other health professionals under contract with the organization.
p.001215: (B) Subparagraph (A) does not apply to the provision of the services of a physician—
p.001215: (i) which the health maintenance organization deter- mines, in conformity with regulations of the Secretary, are
p.001215: unusual or infrequently used, or
p.001215: (ii) which are provided a member of the organization in a manner other than that prescribed by
p.001215: subparagraph
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p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
p.001585: (2) DEPENDENT CHILD DESCRIBED.—A dependent child de- scribed in this paragraph is, with respect to a
p.001585: group health plan or individual health insurance coverage, a beneficiary under the plan who—
p.001585: (A) is a dependent child, under the terms of the plan or coverage, of a participant or beneficiary under the
p.001585: plan or coverage; and
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p.001585: 903 of the Departments of Labor, Health and Human Services, and Edu- cation, and Related Agencies
p.001585: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–438).
p.001585: Subsection (c) of such section 903 concerns effec- tive dates, and paragraph (1) of the subsection provides as follows:
p.001585: ‘‘(1) GROUP PLANS.—
p.001585: ‘‘(A) IN GENERAL.—The amendment made by subsection (a) shall apply to group health plans for plan years
p.001585: beginning on or after the date of enactment of this Act.
p.001585: ‘‘(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group
p.001585: health plan maintained pursuant to 1 or more collective bargaining agreements be- tween employee
p.001585: representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining
p.001585: agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment
p.001585: made by subsection
p.001585: (a) shall not be treated as a termination of such collective bargaining agreement.’’.
p.001585: The Public Law was enacted October 21, 1998.
p.001585: 13 So in law.
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
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p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
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p.001689: (2) contains recommendations for Congress based on the evaluation conducted under subsection (e).
p.001689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001691: PUBLIC HEALTH SERVICE ACT
p.001691: Sec. 3018
p.001691:
p.001691: SEC. 3016. ø300jj–36¿ INFORMATION TECHNOLOGY PROFESSIONALS IN HEALTH CARE.
p.001691: (a) IN GENERAL.—The Secretary, in consultation with the Di- rector of the National Science Foundation, shall
p.001691: provide assistance to institutions of higher education (or consortia thereof) to establish or expand medical health
p.001691: informatics education programs, includ- ing certification, undergraduate, and masters degree programs, for both
p.001691: health care and information technology students to ensure the rapid and effective utilization and development of
p.001691: health informa- tion technologies (in the United States health care infrastructure).
p.001691: (b) ACTIVITIES.—Activities for which assistance may be pro- vided under subsection (a) may include the
p.001691: following:
p.001691: (1) Developing and revising curricula in medical health informatics and related disciplines.
p.001691: (2) Recruiting and retaining students to the program in- volved.
p.001691: (3) Acquiring equipment necessary for student instruction in these programs, including the installation of
p.001691: testbed net- works for student use.
p.001691: (4) Establishing or enhancing bridge programs in the health informatics fields between community colleges
p.001691: and uni- versities.
p.001691: (c) PRIORITY.—In providing assistance under subsection (a), the Secretary shall give preference to the following:
p.001691: (1) Existing education and training programs.
p.001691: (2) Programs designed to be completed in less than six months.
p.001691: SEC. 3017. ø300jj–37¿ GENERAL GRANT AND LOAN PROVISIONS.
p.001691: (a) REPORTS.—The Secretary may require that an entity receiv- ing assistance under this subtitle shall submit to the
p.001691: Secretary, not later than the date that is 1 year after the date of receipt of such assistance, a report
p.001691: that includes—
p.001691: (1) an analysis of the effectiveness of the activities for which the entity receives such assistance, as
p.001691: compared to the goals for such activities; and
p.001691: (2) an analysis of the impact of the project on health care quality and safety.
p.001691: (b) REQUIREMENT TO IMPROVE QUALITY OF CARE AND DE- CREASE IN COSTS.—The National Coordinator shall
p.001691: annually evalu- ate the activities conducted under this subtitle and shall, in award- ing grants, implement the lessons
p.001691: learned from such evaluation in a manner so that awards made subsequent to each such evaluation are made in a
p.001691: manner that, in the determination of the National Coordinator, will result in the greatest improvement in the
p.001691: quality and efficiency of health care.
p.001691: SEC. 3018. ø300jj–38¿ AUTHORIZATION FOR APPROPRIATIONS.
p.001691: For the purposes of carrying out this subtitle, there is author- ized to be appropriated such sums as may be necessary
p.001691: for each of the fiscal years 2009 through 2013.
p.001691:
p.001691:
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p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
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p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885:
p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
p.000885: with the Secretary of Education, may award grants on a competitive basis to institutions of higher education
p.000885: to enhance services for students with mental health or substance use disorders that can lead to school
p.000885: failure, such as depression, substance use disorders, and sui- cide attempts, prevent mental and substance use
p.000885: disorders, reduce stigma, and improve the identification and treatment for students at risk, so that students
p.000885: will successfully complete their studies.
p.000885: (b) USE OF FUNDS.—The Secretary may not make a grant to an institution of higher education under this section
p.000885: unless the in- stitution agrees to use the grant only for one or more of the fol- lowing:
p.000885:
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p.000885: January 30, 2020
p.000885: (1) Educating students, families, faculty, and staff to in- crease awareness of mental and substance use
p.000885: disorders.
p.000885: (2) The operation of hotlines.
p.000885: (3) Preparing informational material.
p.000885: (4) Providing outreach services to notify students about available mental and substance use disorder services.
p.000885: (5) Administering voluntary mental and substance use dis- order screenings and assessments.
p.000885: (6) Supporting the training of students, faculty, and staff to respond effectively to students with
p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
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p.000897: January 30, 2020
p.000897: (A) Screening for suicide risk, suicide intervention services, and services for referral for treatment for
p.000897: individ- uals at risk for suicide.
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: PUBLIC HEALTH SERVICE ACT
p.000899: Sec. 520M
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p.000899: (B) Implementing evidence-based practices to provide treatment for individuals at risk for suicide,
p.000899: including ap- propriate followup services.
p.000899: (C) Raising awareness and reducing stigma of suicide.
p.000899: (b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant Secretary shall—
p.000899: (1) evaluate the activities supported by grants awarded under subsection (a), and disseminate, as appropriate,
p.000899: the find- ings from the evaluation; and
p.000899: (2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities
p.000899: that receive a grant under this section, in order to help such entities to meet the requirements of this section,
p.000899: including assistance with se- lection and implementation of evidence-based interventions and frameworks
p.000899: to prevent suicide.
p.000899: (c) DURATION.—A grant under this section shall be for a period of not more than 5 years.
p.000899: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $30,000,000
p.000899: for the pe- riod of fiscal years 2018 through 2022.
p.000899: SEC. 520M. ø290bb–44¿ ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
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p.000917: January 30, 2020
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p.000917: (c) FEDERAL SHARE.—The Federal share of the costs of a pro- gram funded by a grant under this section may not
p.000917: exceed 85 per- cent.
p.000917: (d) USE OF FUNDS.—Grants awarded under subsection (b)—
p.000917: (1) shall be used to develop, expand, and enhance commu- nity and statewide recovery support services; and
p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
p.000917: (e) SPECIAL CONSIDERATION.—In carrying out this section, the Secretary shall give special consideration to
p.000917: the unique needs of rural areas, including areas with an age-adjusted rate of drug over- dose deaths that is
p.000917: above the national average and areas with a shortage of prevention and treatment services.
p.000917: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section $5,000,000 for
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p.000921: January 30, 2020
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p.000921: (7) STATES WITH LOCAL PRESCRIPTION DRUG MONITORING PROGRAMS.—
p.000921: (A) IN GENERAL.—In the case of a State that does not have a prescription drug monitoring program, a county or
p.000921: other unit of local government within the State that has a prescription drug monitoring program shall be
p.000921: treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1).
p.000921: (B) PLAN FOR INTEROPERABILITY.—In submitting an application to the Secretary under paragraph (3), a county or
p.000921: other unit of local government shall submit a plan out- lining the methods such county or unit of local government
p.000921: shall use to ensure the capability of data sharing with other counties and units of local government
p.000921: within the state and with other States, as applicable.
p.000921: (c) AUTHORIZATION OF FUNDING.—For the purpose of carrying out this section, there are authorized to be
p.000921: appropriated $5,000,000 for each of fiscal years 2017 through 2021.
p.000921: SEC. 549. ø290ee–4¿ MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON COLLEGE CAMPUSES.
p.000921: (a) PURPOSE.—It is the purpose of this section to increase ac- cess to, and reduce the stigma associated
p.000921: with, mental health serv- ices to ensure that students at institutions of higher education have the support
p.000921: necessary to successfully complete their studies.
p.000921: (b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary, acting through the Assistant Secretary and in
p.000921: collaboration with the Director of the Centers for Disease Control and Prevention, shall convene an
p.000921: interagency, public-private sector working group to plan, establish, and begin coordinating and evaluating
p.000921: a tar- geted public education campaign that is designed to focus on men- tal and behavioral health on the campuses of
p.000921: institutions of higher education. Such campaign shall be designed to—
p.000921: (1) improve the general understanding of mental health and mental disorders;
p.000921: (2) encourage help-seeking behaviors relating to the pro- motion of mental health, prevention of mental
p.000921: disorders, and treatment of such disorders;
p.000921: (3) make the connection between mental and behavioral health and academic success; and
p.000921: (4) assist the general public in identifying the early warn- ing signs and reducing the stigma of mental illness.
p.000921: (c) COMPOSITION.—The working group convened under sub- section (b) shall include—
p.000921: (1) mental health consumers, including students and fam- ily members;
p.000921: (2) representatives of institutions of higher education;
p.000921: (3) representatives of national mental and behavioral health associations and associations of
p.000921: institutions of higher education;
p.000921: (4) representatives of health promotion and prevention or- ganizations at institutions of higher education;
p.000921: (5) representatives of mental health providers, including community mental health centers; and
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000923: PUBLIC HEALTH SERVICE ACT
p.000923: Sec. 550
p.000923:
p.000923: (6) representatives of private-sector and public-sector groups with experience in the development of
p.000923: effective public health education campaigns.
p.000923: (d) PLAN.—The working group under subsection (b) shall de- velop a plan that—
p.000923: (1) targets promotional and educational efforts to the age population of students at institutions of
p.000923: higher education and individuals who are employed in settings of institutions of higher education, including
p.000923: through the use of roundtables;
p.000923: (2) develops and proposes the implementation of research- based public health messages and activities;
p.000923: (3) provides support for local efforts to reduce stigma by using the National Health Information Center
p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
p.000923: for the pe- riod of fiscal years 2018 through 2022.
p.000923: SEC. 550. 15 ø290ee–5¿ NATIONAL RECOVERY HOUSING BEST PRAC- TICES.
p.000923: (a) BEST PRACTICES FOR OPERATING RECOVERY HOUSING.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities specified in paragraph
p.000923: (2), shall iden- tify or facilitate the development of best practices, which may include model laws
p.000923: for implementing suggested minimum standards, for operating recovery housing.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate—
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p.000143: PUBLIC HEALTH SERVICE ACT
p.000143: Sec. 317S
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p.000143: political subdivisions of States, for the operation, including im- provement, of control programs.
p.000143: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.000143: preference to a political subdivision or consortium of political subdivisions that—
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p.000143: (A) has—
p.000143: (i) a history of elevated incidence or prevalence of mosquito-borne disease;
p.000143: (ii) a population of infected mosquitoes;
p.000143: (iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence
p.000143: or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-
p.000143: borne disease that presents a serious public health threat; or
p.000143: (iv) a public health emergency due to the inci- dence or prevalence of a mosquito-borne disease that
p.000143: presents a serious public health threat;
p.000143: (B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions
p.000143: will, if appropriate to the mosquito circumstances involved, effec- tively coordinate the activities of the
p.000143: control programs with contiguous political subdivisions;
p.000143: (C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political sub-
p.000143: division or consortium of political subdivisions is located has identified or will identify geographic
p.000143: areas in such State that have a significant need for control programs and will effectively coordinate
p.000143: such programs in such areas; and
p.000143: (D)(i) is located in a State that has received a grant under subsection (a); or
p.000143: (ii) that demonstrates to the Secretary that the control program is consistent with existing State mosquito control
p.000143: plans or policies, or other applicable State preparedness plans.
p.000143: (3) REQUIREMENT OF ASSESSMENT AND PLAN.—A grant may be made under paragraph (1) only if the political
p.000143: subdivision or consortium of political subdivisions involved—
p.000143: (A) has conducted an assessment to determine the im- mediate needs in such subdivision or consortium for a con- trol
p.000143: program, including an entomological survey of poten- tial mosquito breeding areas; and
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p.000157: Sec. 319 PUBLIC HEALTH SERVICE ACT 158
p.000157: dian Self-Determination and Education Assistance Act; and
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p.000157: January 30, 2020
p.000157: (B) the term ‘‘State’’ includes, in addition to the enti- ties listed in the definition of such term
p.000157: in section 2, the Freely Associated States.
p.000157: (8) SUNSET.—This subsection shall terminate on Sep- tember 30, 2023.
p.000157: (f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.—
p.000157: (1) DETERMINATION.—If the Secretary determines, after consultation with such public health officials as may
p.000157: be nec- essary, that—
p.000157: (A)(i) the criteria set forth for a public health emer- gency under paragraph (1) or (2) of subsection (a) has
p.000157: been met; or
p.000157: (ii) a disease or disorder, including a novel and emerg- ing public health threat, is significantly likely to become a
p.000157: public health emergency; and
p.000157: (B) the circumstances of such public health emergency, or potential for such significantly likely public
p.000157: health emergency, including the specific preparation for and re- sponse to such public health emergency or
p.000157: threat, neces- sitate a waiver from the requirements of subchapter I of chapter 35 of title 44, United
p.000157: States Code (commonly re- ferred to as the Paperwork Reduction Act),
p.000157: then the requirements of such subchapter I with respect to vol- untary collection of information shall not be
p.000157: applicable during the immediate investigation of, and response to, such public health emergency during
p.000157: the period of such public health emergency or the period of time necessary to determine if a
p.000157: disease or disorder, including a novel and emerging public health threat, will become a public health
p.000157: emergency as pro- vided for in this paragraph. The requirements of such sub- chapter I with respect to
p.000157: voluntary collection of information shall not be applicable during the immediate postresponse re- view
p.000157: regarding such public health emergency if such imme- diate postresponse review does not exceed a reasonable
p.000157: length of time.
p.000157: (2) TRANSPARENCY.—If the Secretary determines that a waiver is necessary under paragraph (1), the
p.000157: Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief
p.000157: justification for such waiv- er, the anticipated period of time such waiver will be in effect, and the agencies and
p.000157: offices within the Department of Health and Human Services to which such waiver shall apply, and up- date such
p.000157: information posted on the Internet website of the Department of Health and Human Services, as applicable.
p.000157: (3) EFFECTIVENESS OF WAIVER.—Any waiver under this subsection shall take effect on the date on which the
p.000157: Secretary posts information on the Internet website as provided for in this subsection.
p.000157: (4) TERMINATION OF WAIVER.—Upon determining that the circumstances necessitating a waiver under paragraph
p.000157: (1) no longer exist, the Secretary shall promptly update the Internet
p.000157: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000167: January 30, 2020
p.000167:
p.000167: lation of the State an amount equal to the population of such political subdivision.
p.000167: (D) CONTINUITY OF FUNDING.—In determining whether to make an award pursuant to subparagraph (A) to a polit- ical
p.000167: subdivision, the Secretary may consider, as a factor in- dicating that the award should be made, that the political
p.000167: subdivision received public health funding from the Sec- retary for fiscal year 2006.
p.000167: (5) SIGNIFICANT UNMET NEEDS; DEGREE OF RISK.—
p.000167: (A) IN GENERAL.—For fiscal year 2007, the Secretary may, before making awards pursuant to paragraph (3) for such
p.000167: year, reserve from the amount appropriated under paragraph (1) for the year an amount determined nec-
p.000167: essary by the Secretary to make awards under subsection
p.000167: (a) to eligible entities that—
p.000167: (i) have a significant need for funds to build ca- pacity to identify, detect, monitor, and respond to
p.000167: a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3);
p.000167: and
p.000167: (ii) face a particularly high degree of risk of such a threat.
p.000167: (B) RECIPIENTS OF GRANTS.—Awards pursuant to sub- paragraph (A) may be supplemental awards to States that receive
p.000167: awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection
p.000167: (b)(1)(B) within such States.
p.000167: (C) FINDING WITH RESPECT TO DISTRICT OF COLUM- BIA.—The Secretary shall consider the District of Columbia
p.000167: to have a significant unmet need for purposes of subpara- graph (A), and to face a particularly high degree of risk for
p.000167: such purposes, on the basis of the concentration of entities of national significance located within the District.
p.000167: (6) FUNDING OF LOCAL ENTITIES.—The Secretary shall, in making awards under this section, ensure that with
p.000167: respect to the cooperative agreement awarded, the entity make available appropriate portions of such award to
p.000167: political subdivisions and local departments of public health through a process in- volving the consensus,
p.000167: approval or concurrence with such local entities.
p.000167: (7) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
p.000167: (A) IN GENERAL.—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for
p.000167: a fiscal year and remaining unobligated at the end of such year shall remain available to such entity
p.000167: for the next fiscal year for the purposes for which such funds were provided.
p.000167: (B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— The continued availability of funds under subparagraph
p.000167: (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the
p.000167: pan- demic influenza plan as described in subsection (g).
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p.000187: 187
p.000187: PUBLIC HEALTH SERVICE ACT
p.000187: Sec. 319E
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p.000187: January 30, 2020
p.000187: grams relating to antimicrobial resistance. The Secretary may appoint or select a committee, or other
p.000187: organization in exist- ence as of the date of the enactment of this section, to serve as such a task
p.000187: force, if such committee, or other organization meets the requirements of this section.
p.000187: (2) MEMBERS OF TASK FORCE.—The task force described in paragraph (1) shall be composed of representatives from
p.000187: such Federal agencies, and shall seek input from public health con- stituencies, manufacturers, veterinary and medical
p.000187: professional societies and others, as determined to be necessary by the Sec- retary, to develop and implement a
p.000187: comprehensive plan to ad- dress the public health threat of antimicrobial resistance.
p.000187: (3) AGENDA.—
p.000187: (A) IN GENERAL.—The task force described in para- graph (1) shall consider factors the Secretary considers ap-
p.000187: propriate, including—
p.000187: (i) public health factors contributing to increasing antimicrobial resistance;
p.000187: (ii) public health needs to detect and monitor anti- microbial resistance;
p.000187: (iii) detection, prevention, and control strategies for resistant pathogens;
p.000187: (iv) the need for improved information and data collection;
p.000187: (v) the assessment of the risk imposed by patho- gens presenting a threat to the public health; and
p.000187: (vi) any other issues which the Secretary deter- mines are relevant to antimicrobial resistance.
p.000187: (B) DETECTION AND CONTROL.—The Secretary, in con- sultation with the task force described in paragraph
p.000187: (1) and State and local public health officials, shall—
p.000187: (i) develop, improve, coordinate or enhance partici- pation in a surveillance plan to detect and monitor
p.000187: emerging antimicrobial resistance; and
p.000187: (ii) develop, improve, coordinate or enhance par- ticipation in an integrated information system to as-
p.000187: similate, analyze, and exchange antimicrobial resist- ance data between public health departments.
p.000187: (4) MEETINGS.—The task force described under paragraph
p.000187: (1) shall convene not less than twice a year, or more frequently as the Secretary determines to be appropriate.
p.000187: (b) RESEARCH AND DEVELOPMENT OF NEW ANTIMICROBIAL DRUGS AND DIAGNOSTICS.—The Secretary and the
p.000187: Director of Agri- cultural Research Services, consistent with the recommendations of the task force established
p.000187: under subsection (a), shall directly or through awards of grants or cooperative agreements to public or
p.000187: private entities provide for the conduct of research, investigations, experiments, demonstrations, and
p.000187: studies in the health sciences that are related to—
p.000187: (1) the development of new therapeutics, including vac- cines and antimicrobials, against resistant pathogens;
p.000187: (2) the development or testing of medical diagnostics to de- tect pathogens resistant to antimicrobials;
p.000187: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000187:
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p.000187: Sec. 319E PUBLIC HEALTH SERVICE ACT 188
p.000187:
p.000187: (3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
p.000187: (4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens
p.000187: (as deter- mined by the Director of the National Institutes of Health in consultation with the task
p.000187: force established under subsection (a)), in collaboration and coordination with the activities of the Department of
p.000187: Defense and the Joint Genome Institute of the Department of Energy; and
p.000187: (5) other relevant research areas.
p.000187: (c) EDUCATION OF MEDICAL AND PUBLIC HEALTH PERSONNEL.— The Secretary, after consultation with the Assistant
p.000187: Secretary for Health, the Surgeon General, the Director of the Centers for Dis- ease Control and
p.000187: Prevention, the Administrator of the Health Re- sources and Services Administration, the Director of the Agency
p.000187: for Healthcare Research and Quality, members of the task force de- scribed in subsection (a), professional
p.000187: organizations and societies, and such other public health officials as may be necessary, shall—
p.000187: (1) develop and implement educational programs to in- crease the awareness of the general public with respect to
p.000187: the public health threat of antimicrobial resistance and the appro- priate use of antibiotics;
p.000187: (2) develop and implement educational programs to in- struct health care professionals in the prudent use
p.000187: of anti- biotics; and
p.000187: (3) develop and implement programs to train laboratory personnel in the recognition or identification of
p.000187: resistance in pathogens.
p.000187: (d) GRANTS.—
p.000187: (1) IN GENERAL.—The Secretary shall award competitive grants to eligible entities to enable such entities to
p.000187: increase the capacity to detect, monitor, and combat antimicrobial resist- ance.
p.000187: (2) ELIGIBLE ENTITIES.—Eligible entities for grants under paragraph (1) shall be State or local public health
p.000187: agencies, In- dian tribes or tribal organizations, or other public or private nonprofit entities.
p.000187: (3) USE OF FUNDS.—An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for
p.000187: activi- ties that are consistent with the factors identified by the task force under subsection (a)(3),
p.000187: which may include activities that—
p.000187: (A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;
p.000187: (B) develop, improve, coordinate or enhance participa- tion in information systems by which data on resistant in-
p.000187: fections can be shared rapidly among relevant national, State, and local health agencies and health care
p.000187: providers; and
p.000187:
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p.000187:
p.000187: January 30, 2020
p.000187: (C) develop and implement policies to control the spread of antimicrobial resistance.
...

p.000201: committed to agency discretion.
p.000201: SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECU-
p.000201: RITY COUNTERMEASURE PROCUREMENTS. 22
p.000201: (a) STRATEGIC NATIONAL STOCKPILE.—
p.000201: (1) IN GENERAL.—The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and
p.000201: the Di- rector of the Centers for Disease Control and Prevention, and in coordination with the Secretary
p.000201: of Homeland Security (re- ferred to in this section as the ‘‘Homeland Security Secretary’’), shall maintain a
p.000201: stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other
p.000201: supplies in such numbers, types, and amounts as are determined con- sistent with section 2811 by the
p.000201: Secretary to be appropriate and practicable, taking into account other available sources, to provide for and
p.000201: optimize the emergency health security of the United States, including the emergency health security of chil-
p.000201: dren and other vulnerable populations, in the event of a bioter- rorist attack or other public health emergency and, as
p.000201: informed by existing recommendations of, or consultations with, the Public Health Emergency Medical
p.000201: Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the
p.000201: contents of such stockpile or stockpiles based on the review conducted under paragraph (2).
p.000201: (2) THREAT-BASED REVIEW.—
p.000201:
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p.000201:
p.000201:
p.000201: January 30, 2020
p.000201: 22 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–2 and related
p.000201: provisions of law. Section 5 is included in the appendix to this compilation.
p.000201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 202
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p.000201: January 30, 2020
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p.000201: (A) IN GENERAL.—The Secretary shall conduct an an- nual threat-based review (taking into account at-risk indi-
p.000201: viduals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and,
p.000201: in con- sultation with the Public Health Emergency Medical Coun- termeasures Enterprise established under section
p.000201: 2811–1, review contents within the stockpile and assess whether such contents are consistent with the
p.000201: recommendations made pursuant to section 2811–1(c)(1)(A). Such review shall be submitted on June 15,
p.000201: 2019, and on March 15 of each year thereafter, to the Committee on Health, Edu- cation, Labor, and
p.000201: Pensions and the Committee on Appro- priations of the Senate and the Committee on Energy and Commerce and the
p.000201: Committee on Appropriations of the House of Representatives, in a manner that does not com- promise national
p.000201: security.
p.000201: (B) ADDITIONS, MODIFICATIONS, AND REPLENISH- MENTS.—Each annual threat-based review under subpara-
p.000201: graph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—
p.000201: (i) information regarding—
p.000201: (I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for,
p.000201: the stockpile;
p.000201: (II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such
p.000201: additions or modifications (without disclosing proprietary information), including con- sideration of the effect
p.000201: such additions or modifica- tions may have on the availability of such prod- ucts and ancillary medical
p.000201: supplies in the health care system;
p.000201: (III) the presence or lack of a commercial market for the countermeasure at the time of pro- curement;
p.000201: (IV) the emergency health security threat or threats such countermeasure procurement is in- tended to
p.000201: address, including whether such pro- curement is consistent with meeting emergency health security needs
p.000201: associated with such threat or threats;
p.000201: (V) an assessment of whether the emergency health security threat or threats described in sub- clause (IV)
p.000201: could be addressed in a manner that better utilizes the resources of the stockpile and permits the
p.000201: greatest possible increase in the level of emergency preparedness to address such threats;
p.000201: (VI) whether such countermeasure is replen- ishing an expiring or expired countermeasure, is a different
p.000201: countermeasure with the same indication that is replacing an expiring or expired counter- measure, or is a new
p.000201: addition to the stockpile;
p.000201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000203: PUBLIC HEALTH SERVICE ACT
p.000203: Sec. 319F–2
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p.000203: (VII) a description of how such additions or modifications align with projected investments under
p.000203: previous countermeasures budget plans under section 2811(b)(7), including expected life- cycle costs,
p.000203: expenditures related to counter- measure procurement to address the threat or threats described in
p.000203: subclause (IV), replenishment dates (including the ability to extend the max- imum shelf life of a
p.000203: countermeasure), and the manufacturing capacity required to replenish such countermeasure; and
p.000203: (VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the
p.000203: countermeasure at the State and local level, in- cluding plans for relevant capabilities of State and local
p.000203: entities to dispense, distribute, and admin- ister the countermeasure; and
p.000203: (ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured
p.000203: or replenished under this subsection, the Secretary completed a review addressing each item listed
p.000203: under this subsection in advance of such pro- curement or replenishment.
p.000203: (3) PROCEDURES.—The Secretary, in managing the stock- pile under paragraph (1), shall—
p.000203: (A) consult with the working group under section 319F(a) and the Public Health Emergency Medical
p.000203: Coun- termeasures Enterprise established under section 2811–1;
p.000203: (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and
p.000203: accounting, and for the physical security of the stockpile;
p.000203: (C) in consultation with Federal, State, and local offi- cials, take into consideration the timing and
p.000203: location of special events, and the availability, deployment, dis- pensing, and administration of
p.000203: countermeasures;
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p.000203: States; and
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p.000203: (J) provide assistance, including technical assistance, to maintain and improve State and local public health pre-
p.000203: paredness capabilities to distribute and dispense medical countermeasures and products from the stockpile,
p.000203: as ap- propriate.
p.000203: (4) UTILIZATION GUIDELINES.—The Secretary shall ensure timely and accurate recommended utilization guidelines
p.000203: for qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products
p.000203: (as defined in sec- tion 319F–3), and security countermeasures (as defined in sub- section (c)), including for such
p.000203: products in the stockpile.
p.000203: (5) GAO REPORT.—
p.000203: (A) IN GENERAL.—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Prepared-
p.000203: ness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the
p.000203: United States shall conduct a review of any changes to the con- tents or management of the stockpile
p.000203: since January 1, 2015. Such review shall include—
p.000203: (i) an assessment of the comprehensiveness and completeness of each annual threat-based review under
p.000203: paragraph (2), including whether all newly pro- cured or replenished countermeasures within the stockpile
p.000203: were described in each annual review, and whether, consistent with paragraph (2)(B), the Sec- retary
p.000203: conducted the necessary internal review in ad- vance of such procurement or replenishment;
p.000203: (ii) an assessment of whether the Secretary estab- lished health security and science-based justifications, and a
p.000203: description of such justifications for procure- ment decisions related to health security needs with
p.000203: respect to the identified threat, for additions or modi- fications to the stockpile based on the information
p.000203: pro- vided in such reviews under paragraph (2)(B), includ- ing whether such review was conducted prior to
p.000203: pro- curement, modification, or replenishment;
p.000203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000205: PUBLIC HEALTH SERVICE ACT
p.000205: Sec. 319F–2
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p.000205: (iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dis-
p.000205: pensing of countermeasures procured, modified, or re- plenished under paragraph (1), including whether
p.000205: such plans were developed prior to procurement, modi- fication, or replenishment;
p.000205: (iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that re-
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p.000205: SPECIAL RESERVE FUND.—
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p.000205: (1) IN GENERAL.—
p.000205: (A) USE OF FUND.—A security countermeasure may, in accordance with this subsection, be procured with amounts in the
p.000205: special reserve fund as defined in subsection (h).
p.000205: (B) SECURITY COUNTERMEASURE.—For purposes of this subsection, the term ‘‘security countermeasure’’ means a drug
p.000205: (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42
p.000205: U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(h))) that—
p.000205: (i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of
p.000205: the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical,
p.000205: radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, miti-
p.000205: gate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may
p.000205: be caused by administering a drug, biological product, or device against such an agent;
p.000205: (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and
p.000205: (III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under
p.000205: section 351 of this Act; or
p.000205: (bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical ex-
p.000205: perience or research data (including data, if available, from pre-clinical and clinical trials) support a
p.000205: reason- able conclusion that the countermeasure will qualify for approval or licensing within 10 years after the
p.000205: date of a determination under paragraph (5); or
p.000205: (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.
p.000205: (2) DETERMINATION OF MATERIAL THREATS.—
p.000205: (A) MATERIAL THREAT.—The Homeland Security Sec- retary, in consultation with the Secretary and the heads of other
p.000205: agencies as appropriate, shall on an ongoing basis—
p.000205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000207: PUBLIC HEALTH SERVICE ACT
p.000207: Sec. 319F–2
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p.000207: (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and
p.000207: (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to
p.000207: affect national security.
p.000207: (B) PUBLIC HEALTH IMPACT; NECESSARY COUNTER- MEASURES.—The Secretary shall on an ongoing basis—
p.000207: (i) assess the potential public health consequences for the United States population of exposure to agents identified
p.000207: under subparagraph (A)(ii); and
p.000207: (ii) determine, on the basis of such assessment, the agents identified under subparagraph (A)(ii) for
p.000207: which countermeasures are necessary to protect the public health.
p.000207: (C) NOTICE TO CONGRESS.—The Secretary and the Sec- retary of Homeland Security shall send to Congress, on an annual
p.000207: basis, all current material threat determinations and shall promptly notify the Committee on Health, Edu-
p.000207: cation, Labor, and Pensions and the Committee on Home- land Security and Governmental Affairs of the Senate and the
p.000207: Committee on Energy and Commerce and the Com- mittee on Homeland Security of the House of Representa-
p.000207: tives that a determination has been made pursuant to sub- paragraph (A) or (B).
p.000207: (D) ASSURING ACCESS TO THREAT INFORMATION.—In making the assessment and determination required under
p.000207: subparagraph (A), the Homeland Security Secretary shall use all relevant information to which such Secretary is
p.000207: en- titled under section 202 of the Homeland Security Act of 2002, including but not limited to
p.000207: information, regardless of its level of classification, relating to current and emerg- ing threats of chemical,
p.000207: biological, radiological, and nu- clear agents.
p.000207: (3) ASSESSMENT OF AVAILABILITY AND APPROPRIATENESS OF COUNTERMEASURES.—
p.000207: (A) IN GENERAL.—The Secretary, in consultation with the Homeland Security Secretary, shall assess on an ongo- ing
p.000207: basis the availability and appropriateness of specific countermeasures to address specific threats
p.000207: identified under paragraph (2).
p.000207: (B) INFORMATION.—The Secretary shall institute a process for making publicly available the results of assess-
p.000207: ments under subparagraph (A) while withholding such in- formation as—
p.000207: (i) would, in the judgment of the Secretary, tend to reveal public health vulnerabilities; or
p.000207: (ii) would otherwise be exempt from disclosure under section 552 of title 5, United States Code.
p.000207: (4) CALL FOR DEVELOPMENT OF COUNTERMEASURES; COM- MITMENT FOR RECOMMENDATION FOR PROCUREMENT.—
p.000207: (A) PROPOSAL TO THE PRESIDENT.—If, pursuant to an assessment under paragraph (3), the Homeland Security
p.000207: Secretary and the Secretary make a determination that a countermeasure would be appropriate but
p.000207: is either
p.000207: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000217: administra- tion or use of the covered countermeasure, the scope of im- munity includes circumstances in which
p.000217: the counter- measure was administered to or used by an individual in circumstances in which the
p.000217: covered person reasonably could have believed that the countermeasure was adminis- tered or used in accordance
p.000217: with the conditions described in paragraph (3)(C).
p.000217: (5) EFFECT OF DISTRIBUTION METHOD.—The provisions of this section apply to a covered countermeasure
p.000217: regardless of whether such countermeasure is obtained by donation, com- mercial sale, or any other means
p.000217: of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the dec- laration
p.000217: under such subsection provides that subsection (a) ap- plies only to covered countermeasures obtained through a par-
p.000217: ticular means of distribution.
p.000217: (6) REBUTTABLE PRESUMPTION.—For purposes of paragraph (1), there shall be a rebuttable presumption that any
p.000217: adminis- tration or use, during the effective period of the emergency dec- laration by the Secretary under
p.000217: subsection (b), of a covered countermeasure shall have been for the category or categories of diseases,
p.000217: health conditions, or threats to health with respect to which such declaration was issued.
p.000217: (b) DECLARATION BY SECRETARY.—
p.000217: (1) AUTHORITY TO ISSUE DECLARATION.—Subject to para- graph (2), if the Secretary makes a determination
p.000217: that a dis- ease or other health condition or other threat to health con- stitutes a public health
p.000217: emergency, or that there is a credible risk that the disease, condition, or threat may in the future
p.000217: constitute such an emergency, the Secretary may make a dec- laration, through publication in the Federal
p.000217: Register, recom- mending, under conditions as the Secretary may specify, the manufacture, testing,
p.000217: development, distribution, administra- tion, or use of one or more covered countermeasures, and stat- ing that
p.000217: subsection (a) is in effect with respect to the activities so recommended.
p.000217: (2) CONTENTS.—In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered
p.000217: counter- measure specified in the declaration—
p.000217: (A) the category or categories of diseases, health condi- tions, or threats to health for which the Secretary
p.000217: rec- ommends the administration or use of the countermeasure;
p.000217: (B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect,
p.000217: which period or periods may be designated by dates, or by mile- stones or other description of events,
p.000217: including factors specified in paragraph (6);
p.000217: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000219: PUBLIC HEALTH SERVICE ACT
p.000219: Sec. 319F–3
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p.000241: tively, nothing in this subparagraph shall be construed to authorize the Secretary to establish within the De-
p.000241: partment of Health and Human Services an entity for the purposes of carrying out this subparagraph.
p.000241: (vii) TRANSPARENCY AND OVERSIGHT.—Upon re- quest, the Secretary shall provide to Congress the in-
p.000241: formation provided to the Secretary under clause (iv)(V)(dd).
p.000241: (viii) INDEPENDENT EVALUATION.—Not later than 4 years after the date of enactment of the 21st Century Cures Act,
p.000241: the Comptroller General of the United States shall conduct an independent evaluation, and submit to
p.000241: the Secretary and the appropriate commit- tees of Congress a report, concerning the activities conducted
p.000241: under this subparagraph. Such report shall include recommendations with respect to any agree- ment or
p.000241: activities carried out pursuant to this sub- paragraph.
p.000241: (ix) SUNSET.—This subparagraph shall have no force or effect after September 30, 2023.
p.000241: (F) STRATEGIC INITIATIVES.—The Secretary, acting through the Director of BARDA, may implement strategic
p.000241: initiatives, including by building on existing programs and by awarding contracts, grants, and cooperative
p.000241: agree- ments, or entering into other transactions, to support inno- vative candidate products in preclinical and
p.000241: clinical devel- opment that address priority, naturally occurring and man-made threats that, as
p.000241: determined by the Secretary, pose a significant level of risk to national security based on the
p.000241: characteristics of a chemical, biological, radiological or nuclear threat, or existing capabilities to respond
p.000241: to such a threat (including medical response and treatment capabilities and manufacturing infrastructure).
p.000241: Such ini- tiatives shall accelerate and support the advanced re- search, development, and procurement of
p.000241: countermeasures and products, as applicable, to address areas including—
p.000241: (i) chemical, biological, radiological, or nuclear threats, including emerging infectious diseases,
p.000241: for which insufficient approved, licensed, or authorized countermeasures exist, or for which such threat, or the
p.000241: result of an exposure to such threat, may become re- sistant to countermeasures or existing
p.000241: counter- measures may be rendered ineffective;
p.000241: (ii) threats that consistently exist or continually circulate and have a significant potential to become
p.000241: a pandemic, such as pandemic influenza, which may in- clude the advanced research and development, manu-
p.000241: facturing, and appropriate stockpiling of qualified pan- demic or epidemic products, and products, tech-
p.000241: nologies, or processes to support the advanced re-
p.000241: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000241: Sec. 319L PUBLIC HEALTH SERVICE ACT 242
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p.000241: January 30, 2020
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p.000241: search and development of such countermeasures (in- cluding multiuse platform technologies for diagnostics,
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p.000245: January 30, 2020
p.000245: $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended.
p.000245: (e) INAPPLICABILITY OF CERTAIN PROVISIONS.—
p.000245: (1) DISCLOSURE.—
p.000245: (A) NONDISCLOSURE OF INFORMATION.—
p.000245: (i) IN GENERAL.—Information described in clause
p.000245: (ii) shall be deemed to be information described in sec- tion 552(b)(3) of title 5, United States Code.
p.000245: (ii) INFORMATION DESCRIBED.—The information de- scribed in this clause is information relevant to pro- grams of
p.000245: the Department of Health and Human Serv- ices that could compromise national security and re- veal significant
p.000245: and not otherwise publicly known vulnerabilities of existing medical or public health de- fenses against
p.000245: chemical, biological, radiological, or nu- clear threats, and is comprised of—
p.000245: (I) specific technical data or scientific informa- tion that is created or obtained during the coun- termeasure
p.000245: and product advanced research and development carried out under subsection (c);
p.000245: (II) information pertaining to the location se- curity, personnel, and research materials and methods
p.000245: of high-containment laboratories con- ducting research with select agents, toxins, or other agents
p.000245: with a material threat determination under section 319F–2(c)(2); or
p.000245: (III) security and vulnerability assessments.
p.000245: (B) REVIEW.—Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary
p.000245: every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or
p.000245: necessity of continued nondisclosure.
p.000245: (C) REPORTING.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Ad-
p.000245: vancing Innovation Act of 2019, and annually thereafter, the Secretary shall report to the Committee on
p.000245: Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
p.000245: Rep- resentatives on the number of instances in which the Sec- retary has used the authority under this
p.000245: subsection to withhold information from disclosure, as well as the na- ture of any request under section
p.000245: 552 of title 5, United States Code that was denied using such authority.
p.000245: (D) SUNSET.—This paragraph shall cease to have force or effect on the date that is 17 years after the date of en-
p.000245: actment of the Pandemic and All-Hazards Preparedness Act.
p.000245: (2) REVIEW.—Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA
p.000245: under this section and the National Biodefense Science Board under section 319M shall each terminate on
p.000245: the date that is 5 years after the date on which each such group or Board, as applica- ble, was established.
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p.000247: January 30, 2020
p.000247: (i) be chaired or, in the case of a consultation, fa- cilitated by the Secretary;
p.000247: (ii) be open to persons involved in the develop- ment, manufacture, distribution, purchase, or storage of
p.000247: a countermeasure or product, as determined by the Secretary;
p.000247: (iii) be open to the Attorney General, the Sec- retary of Homeland Security, and the Chairman;
p.000247: (iv) be limited to discussions involving covered ac- tivities; and
p.000247: (v) be conducted in such manner as to ensure that no national security, confidential commercial, or pro- prietary
p.000247: information is disclosed outside the meeting or consultation.
p.000247: (C) LIMITATION.—The Secretary may not require par- ticipants to disclose confidential commercial or proprietary
p.000247: information.
p.000247: (D) TRANSCRIPT.—The Secretary shall maintain a com- plete verbatim transcript of each meeting or consultation
p.000247: conducted under this subsection. Such transcript (or a por- tion thereof) shall not be disclosed under section
p.000247: 552 of title 5, United States Code, to the extent that the Sec- retary, in consultation with the
p.000247: Attorney General and the Secretary of Homeland Security, determines that disclo- sure of such transcript
p.000247: (or portion thereof) would pose a threat to national security. The transcript (or portion thereof)
p.000247: with respect to which the Secretary has made such a determination shall be deemed to be information
p.000247: described in subsection (b)(3) of such section 552.
p.000247: (E) EXEMPTION.—
p.000247: (i) IN GENERAL.—Subject to clause (ii), it shall not be a violation of the antitrust laws for any person to
p.000247: participate in a meeting or consultation conducted in accordance with this paragraph.
p.000247: (ii) LIMITATION.—Clause (i) shall not apply to any agreement or conduct that results from a meeting or
p.000247: consultation and that is not covered by an exemption granted under paragraph (4).
p.000247: (2) SUBMISSION OF WRITTEN AGREEMENTS.—The Secretary shall submit each written agreement regarding covered
p.000247: activi- ties that is made pursuant to meetings or consultations con- ducted under paragraph (1) to the
p.000247: Attorney General and the Chairman for consideration. In addition to the proposed agree- ment itself, any submission
p.000247: shall include—
p.000247: (A) an explanation of the intended purpose of the agreement;
p.000247: (B) a specific statement of the substance of the agree- ment;
p.000247: (C) a description of the methods that will be utilized to achieve the objectives of the agreement;
p.000247: (D) an explanation of the necessity for a cooperative effort among the particular participating
p.000247: persons to achieve the objectives of the agreement; and
p.000247: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000387: (ii) the name, address, and applicable license number of the manufacturer of the biological product; and
p.000387: (iii) the expiration date of the biological product.
p.000387: (2)(A) The Secretary shall establish, by regulation, require- ments for the approval, suspension, and
p.000387: revocation of biologics li- censes.
p.000387: (B) PEDIATRIC STUDIES.—A person that submits an ap- plication for a license under this paragraph shall submit
p.000387: to the Secretary as part of the application any assessments required under section 505B of the Federal Food,
p.000387: Drug, and Cosmetic Act.
p.000387: (C) The Secretary shall approve a biologics license applica- tion—
p.000387: (i) on the basis of a demonstration that—
p.000387: (I) the biological product that is the subject of the ap- plication is safe, pure, and potent; and
p.000387: (II) the facility in which the biological product is man- ufactured, processed, packed, or held meets standards
p.000387: de- signed to assure that the biological product continues to be safe, pure, and potent; and
p.000387: (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the
p.000387: subject of the appli- cation, in accordance with subsection (c).
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p.000387: 56 Section 511(d) of Public Law 104–132 (110 Stat. 1284) relates to the regulatory control of biological
p.000387: agents and includes a requirement that the Secretary ‘‘establish and maintain a list of each biological
p.000387: agent that has the potential to pose a severe threat to public health and safe- ty’’.
p.000387: 57 Section 123(f) of Public Law 105–115 (111 Stat. 2324) provides as follows:
p.000387: ‘‘(f) SPECIAL RULE.—The Secretary of Health and Human Services shall take measures to min- imize differences in the
p.000387: review and approval of products required to have approved biologics li- cense applications under section 351 of the
p.000387: Public Health Service Act (42 U.S.C. 262) and prod- ucts required to have approved new drug applications under
p.000387: section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).’’.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000401: scientific and medical evaluation and rec- ommend controls under the Controlled Substances Act, ap- proval
p.000401: of such application shall not take effect until the in- terim final rule controlling the biological
p.000401: product is issued in accordance with section 201(j) of the Controlled Substances Act.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000401: Sec. 351A PUBLIC HEALTH SERVICE ACT 402
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p.000401: (2) DATE OF APPROVAL.—For purposes of this section, with respect to an application described in paragraph (1),
p.000401: references to the date of approval of such application, or licensure of the product subject to such
p.000401: application, shall mean the later of—
p.000401: (A) the date an application is approved under sub- section (a); or
p.000401: (B) the date of issuance of the interim final rule con- trolling the biological product.
p.000401: SEC. 351A. ø262a¿ ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS AND TOXINS. 60
p.000401: (a) REGULATORY CONTROL OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (1) LIST OF BIOLOGICAL AGENTS AND TOXINS.—
p.000401: (A) IN GENERAL.—The Secretary shall by regulation establish and maintain a list of each biological agent
p.000401: and each toxin that has the potential to pose a severe threat to public health and safety.
p.000401: (B) CRITERIA.—In determining whether to include an agent or toxin on the list under subparagraph (A), the Sec-
p.000401: retary shall—
p.000401: (i) consider—
p.000401: (I) the effect on human health of exposure to the agent or toxin;
p.000401: (II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is
p.000401: transferred to humans;
p.000401: (III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent
p.000401: any illness resulting from infection by the agent or toxin; and
p.000401: (IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary
p.000401: considers appropriate; and
p.000401: (ii) consult with appropriate Federal departments and agencies and with scientific experts representing
p.000401: appropriate professional groups, including groups with pediatric expertise.
p.000401: (2) BIENNIAL REVIEW.—The Secretary shall review and re- publish the list under paragraph (1) biennially,
p.000401: or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.
p.000401: (b) REGULATION OF TRANSFERS OF LISTED AGENTS AND TOX-
p.000401: INS.—The Secretary shall by regulation provide for—
p.000401: (1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including
p.000401: measures to ensure—
p.000401: (A) proper training and appropriate skills to handle such agents and toxins; and
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p.000401: 60 A program is carried out by the Secretary of Agriculture with respect to each biological agent and
p.000401: each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant
p.000401: health, or to animal or plant products. Such program has requirements and authorities similar to those established in
p.000401: section 351A above. See subtitle B of title II of Public Law 107–188 (section 211 et seq.; 116 Stat. 647).
p.000401: Subtitle C of such title (section 221 et seq.; 116 Stat. 657) relates to interagency coordination of the two
p.000401: programs.
p.000401: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000403: PUBLIC HEALTH SERVICE ACT
p.000403: Sec. 351A
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p.000403: (B) proper laboratory facilities to contain and dispose of such agents and toxins;
p.000403: (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and
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p.000409:
p.000409: (B) to withhold information from any person under any other Federal law or treaty.
p.000409: (i) CIVIL MONEY PENALTY.— 61
p.000409: (1) IN GENERAL.—In addition to any other penalties that may apply under law, any person who violates
p.000409: any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money
p.000409: penalty in an amount not ex- ceeding $250,000 in the case of an individual and $500,000 in the case of
p.000409: any other person.
p.000409: (2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of section 1128A of the Social Security Act (other
p.000409: than sub- sections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of
p.000409: subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such
p.000409: provisions apply to a penalty or proceeding under sec- tion 1128A(a) of such Act. The Secretary may delegate author-
p.000409: ity under this subsection in the same manner as provided in section 1128A(j)(2) of the Social Security Act,
p.000409: and such author- ity shall include all powers as contained in section 6 of the In- spector General Act of 1978 (5
p.000409: U.S.C. App.).
p.000409: (j) NOTIFICATION IN EVENT OF RELEASE.—Regulations under subsections (b) and (c) shall require the
p.000409: prompt notification of the Secretary by a registered person whenever a release, meeting cri- teria
p.000409: established by the Secretary, of a listed agent or toxin has oc- curred outside of the biocontainment area of a
p.000409: facility of the reg- istered person. Upon receipt of such notification and a finding by the Secretary
p.000409: that the release poses a threat to public health or safety, the Secretary shall take appropriate action
p.000409: to notify rel- evant State and local public health authorities, other relevant Fed- eral authorities, and, if
p.000409: necessary, other appropriate persons (in- cluding the public). If the released listed agent or toxin is an over-
p.000409: lap agent or toxin (as defined in subsection (l)), the Secretary shall promptly notify the Secretary of
p.000409: Agriculture upon notification by the registered person.
p.000409: (k) REPORTS.—
p.000409: (1) IN GENERAL.—The Secretary shall report to the Con- gress annually on the number and nature of
p.000409: notifications re- ceived under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to
p.000409: releases).
p.000409: (2) IMPLEMENTATION OF RECOMMENDATIONS OF THE FED- ERAL EXPERTS SECURITY ADVISORY PANEL AND THE FAST
p.000409: TRACK ACTION COMMITTEE ON SELECT AGENT REGULATIONS.—
p.000409: (A) IN GENERAL.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Pre-
p.000409: paredness and Advancing Innovation Act of 2019, the Sec- retary shall report to the congressional committees of
p.000409: ju- risdiction on the implementation of recommendations of the Federal Experts Security Advisory Panel
p.000409: concerning the select agent program.
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p.000409: January 30, 2020
p.000409: 61 Section 175b of title 18, United States Code, establishes criminal penalties relating to bio- logical
p.000409: agents or toxins that are listed as select agents in Appendix A of part 72 of title 42, Code of
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p.000631: consultation with the directors of the national research insti- tutes and national centers,
p.000631: researchers, patient advocacy groups, and industry leaders.
p.000631: (n) UNIQUE RESEARCH INITIATIVES.—
p.000631: (1) IN GENERAL.—The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A),
p.000631: requests by the national research institutes and centers, or program offi- cers within the Office of the
p.000631: Director to engage in transactions other than a contract, grant, or cooperative agreement with re- spect to projects
p.000631: that carry out—
p.000631: (A) the Precision Medicine Initiative under section 498E;
p.000631: (B) section 402(b)(7), except that not more than 50 percent of the funds available for a fiscal year through
p.000631: the Common Fund under section 402A(c)(1) for purposes of carrying out such section 402(b)(7) may be used to
p.000631: engage in such other transactions; or
p.000631: (C) high impact cutting-edge research that fosters sci- entific creativity and increases fundamental biological
p.000631: un- derstanding leading to the prevention, diagnosis, or treat- ment of diseases and disorders, or
p.000631: research urgently re- quired to respond to a public health threat.
p.000631: (2) REQUIREMENTS.—The authority provided under this subsection may be used to conduct or support high impact
p.000631: cut- ting-edge research described in paragraph (1) using the other transactions authority described in such
p.000631: paragraph if the insti- tute, center, or office—
p.000631: (A) submits a proposal to the Director of NIH for the use of such authority before conducting or
p.000631: supporting the research, including why the use of such authority is essen- tial to promoting the success of the
p.000631: project;
p.000631: (B) receives approval for the use of such authority from the Director of NIH; and
p.000631: (C) for each year in which the institute, center, or of- fice has used such authority in accordance
p.000631: with this sub- section, submits a report to the Director of NIH on the ac- tivities of the institute, center, or
p.000631: office relating to such re- search.
p.000631: SEC. 402A. ø282a¿ AUTHORIZATION OF APPROPRIATIONS.
p.000631: (a) IN GENERAL.—
p.000631: (1) THIS TITLE.—For purposes of carrying out this title, there are authorized to be appropriated—
p.000631: (A) $30,331,309,000 for fiscal year 2007; (B) $32,831,309,000 for fiscal year 2008;
p.000631: (C) such sums as may be necessary for fiscal year 2009;
p.000631: (D) $34,851,000,000 for fiscal year 2018;
p.000631: (E) $35,585,871,000 for fiscal year 2019; and (F) $36,472,442,775 for fiscal year 2020.
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p.000649: (e), and shall consider the recommendations of the National Research Council applicable to surplus
p.000649: chimpanzees that are made in the report published in 1997 and entitled ‘‘Chimpanzees in Re- search—Strategies for
p.000649: Their Ethical Care, Management, and Use’’.
p.000649: (2) CHIMPANZEES ACCEPTED INTO SYSTEM.—With respect to chimpanzees that are accepted into the sanctuary
p.000649: system, standards under paragraph (1) shall include the following:
p.000649: (A) A prohibition that the chimpanzees may not be used for research, except as authorized under
p.000649: paragraph (3).
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p.000649: (B) Provisions regarding the housing of the chim- panzees.
p.000649: (C) Provisions regarding the behavioral well-being of the chimpanzees.
p.000649: (D) A requirement that the chimpanzees be cared for in accordance with the Animal Welfare Act.
p.000649: (E) A requirement that the chimpanzees be prevented from breeding.
p.000649: (F) A requirement that complete histories be main- tained on the health and use in research of the
p.000649: chim- panzees.
p.000649: (G) A requirement that the chimpanzees be monitored for the purpose of promptly detecting the presence in the
p.000649: chimpanzees of any condition that may be a threat to the public health or the health of other chimpanzees.
p.000649: (H) A requirement that chimpanzees posing such a threat be contained in accordance with applicable rec-
p.000649: ommendations of the Director of the Centers for Disease Control and Prevention.
p.000649: (I) A prohibition that none of the chimpanzees may be subjected to euthanasia, except as in the best interests
p.000649: of the chimpanzee involved, as determined by the system and an attending veterinarian.
p.000649: (J) A prohibition that the chimpanzees may not be dis- charged from the system.
p.000649: (K) A provision that the Secretary may, in the discre- tion of the Secretary, accept into the system
p.000649: chimpanzees that are not surplus chimpanzees.
p.000649: (L) Such additional standards as the Secretary deter- mines to be appropriate.
p.000649: (3) RESTRICTIONS REGARDING RESEARCH.—
p.000649: (A) IN GENERAL.—For purposes of paragraph (2)(A), standards under paragraph (1) shall provide that a
p.000649: chim- panzee accepted into the sanctuary system may not be used for studies or research, except that the
p.000649: chimpanzee may be used for noninvasive behavioral studies or medical studies based on information collected during the
p.000649: course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any
p.000649: such study involves minimal physical and mental harm, pain, distress, and dis-
p.000649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000651: PUBLIC HEALTH SERVICE ACT
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p.001623: (8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESIL- IENCY.—Strengthening the ability of States, local
p.001623: communities, and tribal communities to prepare for, respond to, and be resil- ient in the event of public health
p.001623: emergencies, whether natu- rally occurring, unintentional, or deliberate by—
p.001623: (A) optimizing alignment and integration of medical and public health preparedness and response planning and
p.001623: capabilities with and into routine daily activities; and
p.001623: (B) promoting familiarity with local medical and public health systems.
p.001623: (9) ZOONOTIC DISEASE, FOOD, AND AGRICULTURE.—Improv- ing coordination among Federal, State, local, Tribal, and
p.001623: terri- torial entities (including through consultation with the Sec- retary of Agriculture) to prevent,
p.001623: detect, and respond to out- breaks of plant or animal disease (including zoonotic disease) that could
p.001623: compromise national security resulting from a delib- erate attack, a naturally occurring threat, the intentional adul-
p.001623: teration of food, or other public health threats, taking into ac- count interactions between animal health, human
p.001623: health, and animals’ and humans’ shared environment as directly related to public health emergency
p.001623: preparedness and response capa- bilities, as applicable.
p.001623: (10) GLOBAL HEALTH SECURITY.—Assessing current or po- tential health security threats from abroad to inform
p.001623: domestic public health preparedness and response capabilities.
p.001623: SEC. 2803. ø42 U.S.C. 300hh–2¿ ENHANCING MEDICAL SURGE CAPACITY.
p.001623: (a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part of the joint review described in section 2812(b), the
p.001623: Secretary shall evaluate the benefits and feasibility of improving the capacity of the Department of Health
p.001623: and Human Services to provide addi- tional medical surge capacity to local communities in the event of
p.001623: a public health emergency. Such study shall include an assessment of the need for and feasibility of
p.001623: improving surge capacity through—
p.001623: (1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis,
p.001623: to a com- munity in the event of a public health emergency;
p.001623: (2) integrating the practice of telemedicine within the Na- tional Disaster Medical System; and
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p.001625: systems, and emergency medical service systems to ensure effective integration of Federal public health and
p.001625: medical assets during a public health emergency.
p.001625: (C) EMERGENCY MEDICAL SERVICES.—Promote im- proved emergency medical services medical direction, sys-
p.001625: tem integration, research, and uniformity of data collec- tion, treatment protocols, and policies with
p.001625: regard to pub- lic health emergencies.
p.001625: (D) POLICY COORDINATION AND STRATEGIC DIREC- TION.—Provide integrated policy coordination and strategic
p.001625: direction, before, during, and following public health emer- gencies, with respect to all matters related to Federal
p.001625: pub- lic health and medical preparedness and execution and de- ployment of the Federal response for public
p.001625: health emer- gencies and incidents covered by the National Response Plan described in section 504(a)(6) of
p.001625: the Homeland Secu- rity Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; and such Federal responses
p.001625: covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the
p.001625: Homeland Security Act of 2002 (6
p.001625: U.S.C. 149(c)), including public health emergencies or inci- dents related to cybersecurity threats that present a
p.001625: threat to national health security.
p.001625: (E) IDENTIFICATION OF INEFFICIENCIES.—Identify and minimize gaps, duplication, and other inefficiencies
p.001625: in medical and public health preparedness and response ac- tivities and the actions necessary to overcome
p.001625: these obsta- cles.
p.001625: (F) COORDINATION OF GRANTS AND AGREEMENTS.— Align and coordinate medical and public health grants and
p.001625: cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the
p.001625: extent possible, including program requirements, timelines, and measurable goals, and in consultation with
p.001625: the Secretary of Homeland Security, to—
p.001625: (i) optimize and streamline medical and public health preparedness and response capabilities and the ability of
p.001625: local communities to respond to public health emergencies; and
p.001625: (ii) gather and disseminate best practices among grant and cooperative agreement recipients, as appro-
p.001625: priate.
p.001625: (G) DRILL AND OPERATIONAL EXERCISES.—Carry out drills and operational exercises, in consultation with
p.001625: the Department of Homeland Security, the Department of De- fense, the Department of Veterans Affairs, and other appli-
p.001625: cable Federal departments and agencies, as necessary and appropriate, to identify, inform, and address gaps in
p.001625: and policies related to all-hazards medical and public health preparedness and response, including exercises
p.001625: based on—
p.001625: (i) identified threats for which countermeasures are available and for which no countermeasures are
p.001625: available; and
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001627: PUBLIC HEALTH SERVICE ACT
p.001627: Sec. 2811
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p.001627: (ii) unknown threats for which no counter- measures are available.
p.001627: (H) NATIONAL SECURITY PRIORITY.—On a periodic basis consult with, as applicable and appropriate, the Assistant
p.001627: to the President for National Security Affairs, to provide an update on, and discuss, medical and public health
p.001627: pre- paredness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act,
p.001627: including progress on the development, approval, clearance, and li- censure of medical countermeasures.
p.001627: (I) THREAT AWARENESS.—Coordinate with the Director of the Centers for Disease Control and Prevention, the Di-
p.001627: rector of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Secu-
p.001627: rity Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of
p.001627: Agriculture, to maintain a current assessment of national security threats and inform preparedness and response
p.001627: capabilities based on the range of the threats that have the potential to re- sult in a public health
p.001627: emergency.
p.001627: (5) LOGISTICS.—In coordination with the Secretary of Vet- erans Affairs, the Secretary of Homeland Security, the
p.001627: General Services Administration, and other public and private entities, provide logistical support for medical and
p.001627: public health aspects of Federal responses to public health emergencies. Such logistical support shall
p.001627: include working with other relevant Federal, State, local, Tribal, and territorial public health offi-
p.001627: cials and private sector entities to identify the critical infra- structure assets, systems, and networks
p.001627: needed for the proper functioning of the health care and public health sectors that need to be maintained
p.001627: through any emergency or disaster, in- cluding entities capable of assisting with, responding to, and
p.001627: mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary
p.001627: pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T. Stafford
p.001627: Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods
p.001627: to exchange critical informa- tion and deliver products consumed or used to preserve, pro- tect, or sustain
p.001627: life, health, or safety, and sharing of specialized expertise.
p.001627: (6) LEADERSHIP.—Provide leadership in international pro- grams, initiatives, and policies that deal with public
p.001627: health and medical emergency preparedness and response.
p.001627: (7) COUNTERMEASURES BUDGET PLAN.—Develop, and up- date not later than March 15 of each year, a coordinated
p.001627: 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with
p.001627: respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the
p.001627: Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to
p.001627: develop qualified countermeasures (as defined in sec- tion 319F–1), security countermeasures (as defined in
p.001627: section 319F–2), and qualified pandemic or epidemic products (as de-
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001627:
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p.001627: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1628
p.001627: fined in section 319F–3) for each such threat. Each such plan shall—
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p.001627: (A) include consideration of the entire medical coun- termeasures enterprise, including—
p.001627: (i) basic research and advanced research and de- velopment;
p.001627: (ii) approval, clearance, licensure, and authorized uses of products;
p.001627: (iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing ca-
p.001627: pabilities) of all products in the Strategic National Stockpile;
p.001627: (iv) the availability of technologies that may assist in the advanced research and development of counter- measures
p.001627: and opportunities to use such technologies to accelerate and navigate challenges unique to coun- termeasure
p.001627: research and development; and
p.001627: (v) potential deployment, distribution, and utiliza- tion of medical countermeasures; development of clin- ical
p.001627: guidance and emergency use instructions for the use of medical countermeasures; and, as applicable,
p.001627: potential postdeployment activities related to medical countermeasures;
p.001627: (B) inform prioritization of resources and include measurable outputs and outcomes to allow for the
...

p.001629: Ad- ministration to such Assistant Secretary;
p.001629: (3) exercise the responsibilities and authorities of the Sec- retary with respect to the coordination of—
p.001629: (A) the Public Health Emergency Preparedness Coop- erative Agreement Program pursuant to section 319C–1;
p.001629: (B) the Strategic National Stockpile pursuant to sec- tion 319F–2; and
p.001629: (C) the Cities Readiness Initiative; and
p.001629: (4) assume other duties as determined appropriate by the Secretary.
p.001629: (d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
p.001629: (1) IN GENERAL.—Not later than March 15, 2020, and bien- nially thereafter, the Assistant Secretary for Preparedness
p.001629: and Response shall develop and submit to the appropriate commit- tees of Congress a coordinated strategy and
p.001629: accompanying im- plementation plan for medical countermeasures to address chemical, biological,
p.001629: radiological, and nuclear threats. In devel- oping such a plan, the Assistant Secretary for Preparedness and
p.001629: Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section
p.001629: 2811–1. Such strategy and plan shall be known as the ‘‘Public Health Emergency Medical Countermeasures Enterprise
p.001629: Strat- egy and Implementation Plan’’.
p.001629: (2) REQUIREMENTS.—The plan under paragraph (1) shall—
p.001629: (A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a
p.001629: threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in
p.001629: section 319F–1), security countermeasures (as defined in section 319F–2), or quali- fied pandemic or
p.001629: epidemic products (as defined in section 319F–3) for each threat;
p.001629: (B) evaluate the progress of all activities with respect to such countermeasures or products, including
p.001629: research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
p.001629: (C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or
p.001629: products, and ancillary medical supplies to assist with the utiliza- tion of such countermeasures or
p.001629: products, to address a
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001629:
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p.001629: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1630
p.001629: chemical, biological, radiological, and nuclear threat or threats;
p.001629: (D) identify, with respect to each category of threat, a summary of all awards and contracts, including advanced
p.001629: research and development and procurement, that in- cludes—
p.001629: (i) the time elapsed from the issuance of the initial solicitation or request for a proposal to the adjudica-
p.001629: tion (such as the award, denial of award, or solicita- tion termination); and
p.001629: (ii) an identification of projected timelines, antici- pated funding allocations, benchmarks, and milestones for
p.001629: each medical countermeasure priority under sub- paragraph (C), including projected needs with regard to
p.001629: replenishment of the Strategic National Stockpile;
p.001629: (E) be informed by the recommendations of the Na- tional Biodefense Science Board pursuant to section 319M;
p.001629: (F) evaluate progress made in meeting timelines, allo- cations, benchmarks, and milestones identified under sub-
p.001629: paragraph (D)(ii);
p.001629: (G) report on the amount of funds available for pro- curement in the special reserve fund as defined in
p.001629: section 319F–2(h) and the impact this funding will have on meet- ing the requirements under section 319F–2;
p.001629: (H) incorporate input from Federal, State, local, and tribal stakeholders;
p.001629: (I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals
p.001629: (as de- fined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the
p.001629: projected needs for re- lated stockpiling and replenishment of the Strategic Na- tional Stockpile, including
p.001629: by addressing the needs of pedi- atric populations with respect to such countermeasures and products in the
p.001629: Strategic National Stockpile, includ- ing—
p.001629:
p.001629:
p.001629:
...

p.001629: graph (C);
p.001629: (J) identify the use of authority and activities under- taken pursuant to sections 319F–1(b)(1),
p.001629: 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F– 2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv),
p.001629: and 319F–2(c)(7)(C)(v) of
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001629:
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p.001631: 1631
p.001631: PUBLIC HEALTH SERVICE ACT
p.001631: Sec. 2811
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p.001631: January 30, 2020
p.001631: this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act,
p.001631: by sum- marizing—
p.001631: (i) the particular actions that were taken under the authorities specified, including, as applicable, the
p.001631: identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the
p.001631: authority was used;
p.001631: (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options
p.001631: that were considered and rejected with respect to the use of such authorities;
p.001631: (iii) the number of, nature of, and other informa- tion concerning the persons and entities that
p.001631: received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and
p.001631: en- tities that were considered and rejected for such a grant, cooperative agreement, or contract, except
p.001631: that the report need not disclose the identity of any such person or entity;
p.001631: (iv) whether, with respect to each procurement that is approved by the President under section 319F– 2(c)(6), a
p.001631: contract was entered into within one year after such approval by the President; and
p.001631: (v) with respect to section 319F–1(d), for the 2- year period for which the report is submitted, the
p.001631: number of persons who were paid amounts totaling
p.001631: $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less
p.001631: than $100,000; and
p.001631: (K) be made publicly available.
p.001631: (3) GAO REPORT.—
p.001631: (A) IN GENERAL.—Not later than 1 year after the date of the submission to the Congress of the first
p.001631: Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller
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p.001631: January 30, 2020
p.001631:
p.001631: (e) PROTECTION OF NATIONAL SECURITY.—In carrying out sub- sections (b)(7) and (d), the Secretary shall ensure
p.001631: that information and items that could compromise national security, contain con- fidential commercial
p.001631: information, or contain proprietary informa- tion are not disclosed.
p.001631: (f) PROTECTION OF NATIONAL SECURITY FROM THREATS.—
p.001631: (1) IN GENERAL.—In carrying out subsection (b)(3), the As- sistant Secretary for Preparedness and Response shall
p.001631: imple- ment strategic initiatives or activities to address threats, in- cluding pandemic influenza and which
p.001631: may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant
p.001631: potential to become a pandemic), that pose a significant level of risk to public health and national se- curity based
p.001631: on the characteristics of such threat. Such initia- tives shall include activities to—
p.001631: (A) accelerate and support the advanced research, de- velopment, manufacturing capacity, procurement,
p.001631: and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F);
p.001631: (B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus
p.001631: strains; and
p.001631: (C) maintain or improve preparedness activities, in- cluding for pandemic influenza.
p.001631: (2) AUTHORIZATION OF APPROPRIATIONS.—
p.001631: (A) IN GENERAL.—To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fis- cal
p.001631: years 2019 through 2023.
p.001631: (B) SUPPLEMENT, NOT SUPPLANT.—Amounts appro- priated under this paragraph shall be used to supplement and not
p.001631: supplant funds provided under sections 319L(d) and 319F–2(g).
p.001631: (C) DOCUMENTATION REQUIRED.—The Assistant Sec- retary for Preparedness and Response, in accordance with subsection
p.001631: (b)(7), shall document amounts expended for purposes of carrying out this subsection, including
p.001631: amounts appropriated under the heading ‘‘Public Health and Social Services Emergency Fund’’ under the
p.001631: heading ‘‘Office of the Secretary’’ under title II of division H of the Consolidated Appropriations Act, 2018
p.001631: (Public Law 115–
p.001631: 141) and allocated to carrying out section 319L(c)(4)(F).
p.001631: SEC. 2811–1. ø42 U.S.C. 300hh–10a¿ PUBLIC HEALTH EMERGENCY MED- ICAL COUNTERMEASURES ENTERPRISE.
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p.001645: and re- sponse strategies and capabilities that take into account the medical and public health needs of
p.001645: at-risk individuals in the event of a public health emergency, as described in section
p.001645: 319C–1(b)(2)(A)(iii);
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645:
p.001645: (5) ensure that the contents of the strategic national stock- pile take into account at-risk populations as
p.001645: described in sec- tion 2802(b)(4)(B);
p.001645: (6) oversee curriculum development for the public health and medical response training program on medical
p.001645: manage- ment of casualties, as it concerns at-risk individuals as de- scribed in subparagraphs (A) through (C)
p.001645: of section 319F(a)(2);
p.001645: (7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk
p.001645: individuals before, during, and following public health emergencies in as timely a manner as is practicable,
p.001645: including from the time a public health threat is identified;
p.001645: (8) ensure that public health and medical information dis- tributed by the Department of Health and Human
p.001645: Services during a public health emergency is delivered in a manner that takes into account the range of communication
p.001645: needs of the in- tended recipients, including at-risk individuals; and
p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
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p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
...

p.000403: (D) limit or deny access to such agents and toxins by individuals whom the Attorney General has
p.000403: identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the
p.000403: individuals involved is deter- mined appropriate by the Secretary, in consultation with the Attorney General.
p.000403: (3) SUBMITTED NAMES; USE OF DATABASES BY ATTORNEY GENERAL.—
p.000403: (A) IN GENERAL.—Upon the receipt of names and other identifying information under paragraph (2)(B), the Attor-
p.000403: ney General shall, for the sole purpose of identifying whether the individuals involved are within any
p.000403: of the cat- egories specified in subparagraph (B), promptly use crimi- nal, immigration, national security, and
p.000403: other electronic databases that are available to the Federal Government and are appropriate for such purpose.
p.000403: (B) CERTAIN INDIVIDUALS.—For purposes of subpara- graph (A), the categories specified in this subparagraph re-
p.000403: garding an individual are that—
p.000403: (i) the individual is a restricted person; or
p.000403: (ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of—
p.000403: (I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;
p.000403: (II) knowing involvement with an organiza- tion that engages in domestic or international ter- rorism (as defined
p.000403: in section 2331 of such title 18) or with any other organization that engages in in- tentional crimes of violence; or
p.000403: (III) being an agent of a foreign power (as de- fined in section 1801 of title 50, United States Code).
p.000403: (C) NOTIFICATION BY ATTORNEY GENERAL REGARDING SUBMITTED NAMES.—After the receipt of a name and other
p.000403: identifying information under paragraph (2)(B), the Attor- ney General shall promptly notify the Secretary
p.000403: whether the individual is within any of the categories specified in subparagraph (B).
p.000403: (4) NOTIFICATIONS BY SECRETARY.—The Secretary, after re- ceiving notice under paragraph (3) regarding an
p.000403: individual, shall promptly notify the registered person involved of whether the individual is granted or denied access
p.000403: under paragraph (2).
p.000403: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: (1) CONTROLLED SUBSTANCE.—The term ‘‘controlled sub- stance’’ has the meaning given that term in section 102 of
p.000471: the Controlled Substances Act.
p.000471: (2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the mean- ing given that term in section 4 of the Indian
p.000471: Self-Determina- tion and Education Assistance Act.
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000471:
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p.000473: 473
p.000473: PUBLIC HEALTH SERVICE ACT
p.000473: Sec. 393A
p.000473:
p.000473: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, section 399O of this Act, and
p.000473: section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), there is authorized
p.000473: to be appropriated $496,000,000 for each of fiscal years 2019 through 2023.
p.000473:
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p.000473: January 30, 2020
p.000473: INTERPERSONAL VIOLENCE WITHIN FAMILIES AND AMONG ACQUAINTANCES
p.000473: SEC. 393. ø280b–1a¿ (a) With respect to activities that are au- thorized in sections 391 and 392, the Secretary, acting
p.000473: through the Director of the Centers for Disease Control and Prevention, shall carry out such activities
p.000473: with respect to interpersonal violence within families and among acquaintances. Activities authorized in the
p.000473: preceding sentence include the following:
p.000473: (1) Collecting data relating to the incidence of such vio- lence.
p.000473: (2) Making grants to public and nonprofit private entities for the evaluation of programs whose purpose
p.000473: is to prevent such violence, including the evaluation of demonstration projects under paragraph (6).
p.000473: (3) Making grants to public and nonprofit private entities for the conduct of research on identifying
p.000473: effective strategies for preventing such violence.
p.000473: (4) Providing to the public information and education on such violence, including information and education to
p.000473: increase awareness of the public health consequences of such violence.
p.000473: (5) Training health care providers as follows:
p.000473: (A) To identify individuals whose medical conditions or statements indicate that the individuals are victims of
p.000473: such violence.
p.000473: (B) To routinely determine, in examining patients, whether the medical conditions or statements of the
p.000473: pa- tients so indicate.
p.000473: (C) To refer individuals so identified to entities that provide services regarding such violence,
p.000473: including refer- rals for counseling, housing, legal services, and services of community organizations.
p.000473: (6) Making grants to public and nonprofit private entities for demonstration projects with respect to
p.000473: such violence, in- cluding with respect to prevention.
p.000473: (b) For purposes of this part, the term ‘‘interpersonal violence within families and among acquaintances’’
p.000473: includes behavior com- monly referred to as domestic violence, sexual assault, spousal abuse, woman
p.000473: battering, partner abuse, elder abuse, and acquaint- ance rape.
p.000473: SEC. 393A. ø280b–1b¿ USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.
p.000473: (a) PERMITTED USE.—The Secretary, acting through the Na- tional Center for Injury Prevention and Control at the
p.000473: Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape
p.000473: prevention and education programs con- ducted by rape crisis centers, State, territorial or tribal sexual as-
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000473:
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p.000473: Sec. 393A PUBLIC HEALTH SERVICE ACT 474
p.000473: sault coalitions, and other public and private nonprofit entities for—
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p.000473: sexual as- sault at colleges and universities;
p.000473: (6) education to increase awareness about drugs and alco- hol used to facilitate rapes or sexual assaults; and
p.000473: (7) other efforts to increase awareness of the facts about, or to help prevent, sexual assault, including
p.000473: efforts to increase awareness in underserved communities and awareness among individuals with disabilities (as
p.000473: defined in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102)).
p.000473: (b) COLLECTION AND DISSEMINATION OF INFORMATION ON SEX- UAL ASSAULT.—The Secretary shall, through the National
p.000473: Resource Center on Sexual Assault established under the National Center for Injury Prevention and Control
p.000473: at the Centers for Disease Con- trol and Prevention, provide resource information, policy, training, and
p.000473: technical assistance to Federal, State, local, and Indian tribal agencies, as well as to State sexual assault
p.000473: coalitions and local sex- ual assault programs and to other professionals and interested par- ties on issues
p.000473: relating to sexual assault, including maintenance of a central resource library in order to collect, prepare,
p.000473: analyze, and disseminate information and statistics and analyses thereof relat- ing to the incidence and
p.000473: prevention of sexual assault.
p.000473: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.000473: (1) IN GENERAL.—There is authorized to be appropriated to carry out this section $50,000,000 for each of fiscal years
p.000473: 2014 through 2018.
p.000473: (2) NATIONAL SEXUAL VIOLENCE RESOURCE CENTER ALLOT- MENT.—Of the total amount made available under this
p.000473: sub- section in each fiscal year, not less than $1,500,000 shall be available for allotment under subsection
p.000473: (b).
p.000473: (3) BASELINE FUNDING FOR STATES, THE DISTRICT OF CO- LUMBIA, AND PUERTO RICO.—A minimum allocation of
p.000473: $150,000 shall be awarded in each fiscal year for each of the States, the District of Columbia, and Puerto Rico.
p.000473: A minimum allocation of $35,000 shall be awarded in each fiscal year for each Terri- tory. Any unused or
p.000473: remaining funds shall be allotted to each State, the District of Columbia, and Puerto Rico on the basis
p.000473: of population.
p.000473: (d) LIMITATIONS.—
p.000473: (1) SUPPLEMENT NOT SUPPLANT.—Amounts provided to States under this section shall be used to supplement and
p.000473: not supplant other Federal, State, and local public funds expended to provide services of the type described in
p.000473: subsection (a).
p.000473: (2) STUDIES.—A State may not use more than 2 percent of the amount received by the State under this section
p.000473: for each fiscal year for surveillance studies or prevalence studies.
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000475: 475
p.000475: PUBLIC HEALTH SERVICE ACT
p.000475: Sec. 393B
p.000475:
p.000475: (3) ADMINISTRATION.—A State may not use more than 5 percent of the amount received by the State under this
p.000475: section for each fiscal year for administrative expenses.
p.000475:
...

p.000479: (2) REPORT.—If the Secretary conducts the review under paragraph (1), the Secretary shall, not later than
p.000479: 36 months after the date of enactment of the Safety of Seniors Act of 2007, submit to Congress a
p.000479: report describing the findings of the Secretary in conducting such review.
p.000479: GENERAL PROVISIONS
p.000479: SEC. 394. ø280b–2¿ (a) The Secretary, acting through the Di- rector of the Centers for Disease Control and
p.000479: Prevention, shall es- tablish an advisory committee to advise the Secretary and such Di- rector with respect to the
p.000479: prevention and control of injuries.
p.000479: (b) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may
p.000479: provide technical assist- ance to public and nonprofit private entities with respect to the planning,
p.000479: development, and operation of any program or service carried out pursuant to this part. The Secretary may
p.000479: provide such technical assistance directly or through grants or contracts.
p.000479: (c) Not later than February 1 of 1995 and of every second year thereafter, the Secretary, acting through the
p.000479: Director of the Cen- ters for Disease Control and Prevention, shall submit to the Com- mittee on Energy
p.000479: and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Sen- ate,
p.000479: a report describing the activities carried out under this part during the preceding 2 fiscal years. Such
p.000479: report shall include a de- scription of such activities that were carried out with respect to interpersonal
p.000479: violence within families and among acquaintances and with respect to rural areas.
p.000479: SEC. 394A. ø280b–3¿ AUTHORIZATIONS OF APPROPRIATIONS.
p.000479: (a) IN GENERAL.—For the purpose of carrying out this part, there are authorized to be appropriated $50,000,000
p.000479: for fiscal year 1994, and 89 such sums as may be necessary for each of the fiscal years 1995 through
p.000479: 1998, and such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000479: (b) TRAUMATIC BRAIN INJURY.—To carry out sections 393B and 393C, there are authorized to be appropriated $11,750,000
p.000479: for each of fiscal years 2020 through 2024.
p.000479:
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p.000479: January 30, 2020
p.000479: 89 So in law. Section 1306 of Public Law 106–310 (114 Stat. 1143) attempts to strike ‘‘and’’, but the
p.000479: amendment cannot be executed because the instructions were to strike ‘‘and’’ after ‘‘1994’’. (The word
p.000479: ‘‘and’’ appears after ‘‘1994,’’, not ‘‘1994’’.)
p.000479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000479:
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p.000479:
p.000479: Sec. 395 PUBLIC HEALTH SERVICE ACT 480
p.000479:
p.000479: PART K—HEALTH CARE SERVICES IN THE HOME AND PUBLIC HEALTH PROGRAMS FOR DEMENTIA 90
p.000479: Subpart I—Grants for Demonstration Projects
p.000479: SEC. 395. ø280c¿ ESTABLISHMENT OF PROGRAM.
p.000479: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
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p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: Sec. 399A PUBLIC HEALTH SERVICE ACT 496
p.000495:
p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
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p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
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p.000537: respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of
p.000537: professional practice or research.
p.000537: (9) The term ‘‘State’’ means each of the 50 States, the Dis- trict of Columbia, and any commonwealth or
p.000537: territory of the United States.
p.000537: (10) The term ‘‘ultimate user’’ means a person who has ob- tained from a dispenser, and who possesses, a
p.000537: controlled sub- stance for the person’s own use, for the use of a member of the person’s household, or for the
p.000537: use of an animal owned by the person or by a member of the person’s household.
p.000537: (11) The term ‘‘clinical workflow’’ means the integration of automated queries for prescription drug monitoring
p.000537: programs
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: PUBLIC HEALTH SERVICE ACT
p.000539: Sec. 399P
p.000539:
p.000539: data and analytics into health information technologies such as electronic health record systems, health information
p.000539: exchanges, and/or pharmacy dispensing software systems, thus stream- lining provider access through automated
p.000539: queries.
p.000539: SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYS- TEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING
p.000539: VIO- LENCE, SEXUAL ASSAULT, AND STALKING.
p.000539: (a) IN GENERAL.—The Secretary shall award grants for—
p.000539: (1) the development or enhancement and implementation of interdisciplinary training for health
p.000539: professionals, public health staff, and allied health professionals;
p.000539: (2) the development or enhancement and implementation of education programs for medical, nursing, dental,
p.000539: and other health profession students and residents to prevent and re- spond to domestic violence, dating
p.000539: violence, sexual assault, and stalking; and
p.000539: (3) the development or enhancement and implementation of comprehensive statewide strategies to improve the
p.000539: response of clinics, public health facilities, hospitals, and other health settings (including behavioral
p.000539: and mental health programs) to domestic violence, dating violence, sexual assault, and stalking.
p.000539: (b) USE OF FUNDS.—
p.000539: (1) REQUIRED USES.—Amounts provided under a grant under this section shall be used to—
p.000539: (A) fund interdisciplinary training and education pro- grams under paragraphs (1) and (2) of
p.000539: subsection (a) that—
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p.000539: (i) are designed to train medical, psychology, den- tal, social work, nursing, and other health profession
p.000539: students, interns, residents, fellows, or current health care providers to identify and provide health care serv-
p.000539: ices (including mental or behavioral health care serv- ices and referrals to appropriate community
p.000539: services) to individuals who are or who have been victims of do- mestic violence, dating violence, sexual
p.000539: assault, or stalking; and
p.000539: (ii) plan and develop culturally competent clinical training components for integration into approved in-
p.000539: ternship, residency, and fellowship training or con- tinuing medical or other health education training
p.000539: that address physical, mental, and behavioral health issues, including protective factors, related to domestic
p.000539: violence, dating violence, sexual assault, stalking, and other forms of violence and abuse, focus on reducing
p.000539: health disparities and preventing violence and abuse, and include the primacy of victim safety and confiden-
p.000539: tiality;
p.000539: (B) design and implement comprehensive strategies to improve the response of the health care system to domestic or
p.000539: sexual violence in clinical and public health settings, hospitals, clinics, and other health settings
p.000539: (including be- havioral and mental health), under subsection (a)(3) through—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: (i) the implementation, dissemination, and evalua- tion of policies and procedures to guide health profes-
p.000539: sionals and public health staff in identifying and re- sponding to domestic violence, dating violence,
p.000539: sexual assault, and stalking, including strategies to ensure that health information is maintained in a
p.000539: manner that protects the patient’s privacy and safety, and safely uses health information technology to
p.000539: improve documentation, identification, assessment, treatment, and follow-up care;
p.000539: (ii) the development of on-site access to services to address the safety, medical, and mental health needs of
p.000539: patients by increasing the capacity of existing health care professionals and public health staff to ad-
p.000539: dress domestic violence, dating violence, sexual as- sault, and stalking, or by contracting with or
p.000539: hiring domestic or sexual assault advocates to provide such services or to model other services
p.000539: appropriate to the geographic and cultural needs of a site;
p.000539: (iii) the development of measures and methods for the evaluation of the practice of identification, inter-
p.000539: vention, and documentation regarding victims of do- mestic violence, dating violence, sexual assault, and
p.000539: stalking, including the development and testing of quality improvement measurements, in accordance
p.000539: with the multi-stakeholder and quality measurement processes established under paragraphs (7) and (8) of
p.000539: section 1890(b) and section 1890A of the Social Secu- rity Act (42 U.S.C. 1395aaa(b)(7) and (8); 42
p.000539: U.S.C. 1890A); and
p.000539: (iv) the provision of training and follow-up tech- nical assistance to health care professionals, and pub- lic
p.000539: health staff, and allied health professionals to iden- tify, assess, treat, and refer clients who are victims of
p.000539: domestic violence, dating violence, sexual assault, or stalking, including using tools and training
p.000539: materials already developed.
p.000539: (2) PERMISSIBLE USES.—
p.000539: (A) CHILD AND ELDER ABUSE.—To the extent consistent with the purpose of this section, a grantee may
p.000539: use amounts received under this section to address, as part of a comprehensive programmatic approach
p.000539: implemented under the grant, issues relating to child or elder abuse.
p.000539: (B) RURAL AREAS.—Grants funded under paragraphs
p.000539: (1) and (2) of subsection (a) may be used to offer to rural areas community-based training
p.000539: opportunities, which may include the use of distance learning networks and other available technologies
p.000539: needed to reach isolated rural areas, for medical, nursing, and other health profession students and residents on
p.000539: domestic violence, dating violence, sexual assault, stalking, and, as appropriate, other forms of vio- lence
p.000539: and abuse.
p.000539: (C) OTHER USES.—Grants funded under subsection (a)(3) may be used for—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: PUBLIC HEALTH SERVICE ACT
p.000541: Sec. 399P
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p.000541: (i) the development of training modules and poli- cies that address the overlap of child abuse, domestic
p.000541: violence, dating violence, sexual assault, and stalking and elder abuse, as well as childhood exposure to
p.000541: do- mestic and sexual violence;
p.000541: (ii) the development, expansion, and implementa- tion of sexual assault forensic medical examination or sexual
p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
p.000541: dress issues of confidentiality and patient safety and com- ply with applicable confidentiality and nondisclosure
p.000541: re- quirements under section 40002(b)(2) of the Violence Against Women Act of 1994 and the Family Violence
p.000541: Pre- vention and Services Act, and that faculty and staff associ- ated with delivering educational components
p.000541: are fully trained in procedures that will protect the immediate and ongoing security and confidentiality
p.000541: of the patients, pa- tient records, and staff. Such grantees shall consult enti- ties with demonstrated
p.000541: expertise in the confidentiality and safety needs of victims of domestic violence, dating vio- lence, sexual
p.000541: assault, and stalking on the development and adequacy of confidentially and security procedures, and provide
p.000541: documentation of such consultation.
p.000541: (B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.— Grantees under this section shall provide to patients
p.000541: ad- vance notice about any circumstances under which infor- mation may be disclosed, such as mandatory
p.000541: reporting laws, and shall give patients the option to receive informa- tion and referrals without affirmatively
p.000541: disclosing abuse.
p.000541: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee shall use not more than 10 percent of the amounts
p.000541: received under a grant under this section for administrative expenses.
p.000541: (3) APPLICATION.—
p.000541: (A) PREFERENCE.—In selecting grant recipients under this section, the Secretary shall give preference to
p.000541: appli- cants based on the strength of their evaluation strategies, with priority given to outcome based evaluations.
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: Sec. 399P PUBLIC HEALTH SERVICE ACT 542
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p.000541: (B) SUBSECTION (A)(1) AND (2) GRANTEES.—Applications for grants under paragraphs (1) and (2) of subsection
p.000541: (a) shall include—
p.000541: (i) documentation that the applicant represents a team of entities working collaboratively to strengthen
p.000541: the response of the health care system to domestic vio- lence, dating violence, sexual assault, or stalking, and which
p.000541: includes at least one of each of—
p.000541: (I) an accredited school of allopathic or osteo- pathic medicine, psychology, nursing, dentistry, social
p.000541: work, or other health field;
p.000541: (II) a health care facility or system; or
p.000541: (III) a government or nonprofit entity with a history of effective work in the fields of domestic
p.000541: violence, dating violence, sexual assault, or stalk- ing; and
p.000541: (ii) strategies for the dissemination and sharing of curricula and other educational materials developed under
p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
p.000541: nonprofit victim advocacy organizations, State or trib- al law enforcement task forces (where appropriate), and
p.000541: population specific organizations with dem- onstrated expertise in domestic violence, dating vio-
p.000541: lence, sexual assault, or stalking;
p.000541: (iv) with respect to an application for a grant under which the grantee will have contact with pa-
p.000541: tients, a plan, developed in collaboration with local victim service providers, to respond appropriately
p.000541: to and make correct referrals for individuals who disclose that they are victims of domestic violence, dating
p.000541: vio- lence, sexual assault, stalking, or other types of vio- lence, and documentation provided by the
p.000541: grantee of an ongoing collaborative relationship with a local vic- tim service provider; and
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000543: 543
p.000543: PUBLIC HEALTH SERVICE ACT
p.000543: Sec. 399P
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p.000543: (v) with respect to an application for a grant pro- posing to fund a program described in
p.000543: subsection (b)(2)(C)(ii), a certification that any sexual assault fo- rensic medical examination and sexual
p.000543: assault nurse examiner programs supported with such grant funds will adhere to the guidelines set forth by the
p.000543: Attorney General.
p.000543: (d) ELIGIBLE ENTITIES.—
p.000543: (1) IN GENERAL.—To be eligible to receive funding under paragraph (1) or (2) of subsection (a), an entity shall
p.000543: be—
p.000543: (A) a nonprofit organization with a history of effective work in the field of training health professionals
p.000543: with an understanding of, and clinical skills pertinent to, domestic violence, dating violence, sexual assault,
p.000543: or stalking, and lifetime exposure to violence and abuse;
p.000543: (B) an accredited school of allopathic or osteopathic medicine, psychology, nursing, dentistry, social work, or
p.000543: al- lied health;
p.000543: (C) a health care provider membership or professional organization, or a health care system; or
p.000543: (D) a State, tribal, territorial, or local entity.
p.000543: (2) SUBSECTION (A)(3) GRANTEES.—To be eligible to receive funding under subsection (a)(3), an entity shall be—
p.000543: (A) a State department (or other division) of health, a State, tribal, or territorial domestic violence or
p.000543: sexual as- sault coalition or victim service provider, or any other non- profit, nongovernmental organization with
p.000543: a history of ef- fective work in the fields of domestic violence, dating vio- lence, sexual assault, or
p.000543: stalking, and health care, includ- ing physical or mental health care; or
p.000543: (B) a local victim service provider, a local department (or other division) of health, a local health clinic,
p.000543: hospital, or health system, or any other community-based organiza- tion with a history of effective work in the field
p.000543: of domestic violence, dating violence, sexual assault, or stalking and health care, including physical or mental
p.000543: health care.
p.000543: (e) TECHNICAL ASSISTANCE.—
p.000543: (1) IN GENERAL.—Of the funds made available to carry out this section for any fiscal year, the Secretary may make
p.000543: grants or enter into contracts to provide technical assistance with re- spect to the planning, development, and
p.000543: operation of any pro- gram, activity or service carried out pursuant to this section. Not more than 8
p.000543: percent of the funds appropriated under this section in each fiscal year may be used to fund technical assist- ance
p.000543: under this subsection.
p.000543: (2) AVAILABILITY OF MATERIALS.—The Secretary shall make publicly available materials developed by grantees under
p.000543: this section, including materials on training, best practices, and re- search and evaluation.
p.000543: (3) REPORTING.—The Secretary shall publish a biennial re- port on—
p.000543: (A) the distribution of funds under this section; and
p.000543: (B) the programs and activities supported by such funds.
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000543: Sec. 399Q PUBLIC HEALTH SERVICE ACT 544
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p.000543: (f) RESEARCH AND EVALUATION.—
p.000543: (1) IN GENERAL.—Of the funds made available to carry out this section for any fiscal year, the Secretary may use not
p.000543: more than 20 percent to make a grant or enter into a contract for research and evaluation of—
p.000543: (A) grants awarded under this section; and
p.000543: (B) other training for health professionals and effec- tive interventions in the health care setting that
p.000543: prevent domestic violence, dating violence, and sexual assault across the lifespan, prevent the
p.000543: health effects of such vio- lence, and improve the safety and health of individuals who are currently being
p.000543: victimized.
p.000543: (2) RESEARCH.—Research authorized in paragraph (1) may include—
p.000543: (A) research on the effects of domestic violence, dating violence, sexual assault, and childhood exposure to domes-
p.000543: tic, dating or sexual violence on health behaviors, health conditions, and health status of individuals,
p.000543: families, and populations, including underserved populations;
p.000543: (B) research to determine effective health care inter- ventions to respond to and prevent domestic violence,
p.000543: dat- ing violence, sexual assault, and stalking;
p.000543: (C) research on the impact of domestic, dating and sexual violence, childhood exposure to such violence,
p.000543: and stalking on the health care system, health care utilization, health care costs, and health status; and
p.000543: (D) research on the impact of adverse childhood expe- riences on adult experience with domestic violence, dating
p.000543: violence, sexual assault, stalking, and adult health out- comes, including how to reduce or prevent the
p.000543: impact of adverse childhood experiences through the health care set- ting.
p.000543: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000543: $10,000,000 for each of fiscal years 2014 through 2018.
p.000543: (h) DEFINITIONS.—Except as otherwise provided herein, the definitions provided for in section 40002 of the
p.000543: Violence Against Women Act of 1994 shall apply to this section.
p.000543: SEC. 399Q. ø280g–4¿ PUBLIC AND HEALTH CARE PROVIDER EDU- CATION AND SUPPORT SERVICES.
p.000543: (a) IN GENERAL.—The Secretary, directly or through the awarding of grants to public or private nonprofit
p.000543: entities, may con- duct activities, which may include demonstration projects for the purpose of improving
p.000543: the provision of information on prematurity to health professionals and other health care providers and
p.000543: the public and improving the treatment and outcomes mothers of in- fants born preterm, and infants born
p.000543: preterm, as appropriate.
p.000543: (b) ACTIVITIES.—Activities to be carried out under subsection
p.000543: (a) may include the establishment of—
p.000543: (1) programs, including those to test and evaluate strate- gies, which, in collaboration with States,
p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000745: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of alcohol
p.000745: abuse and alcoholism. In carrying out the program, the Director of the Institute is author- ized to—
p.000745: (1) collect and disseminate through publications and other appropriate means (including the development of
p.000745: curriculum materials), information as to, and the practical application of, the research and other activities
p.000745: under the program;
p.000745: (2) make available research facilities of the Public Health Service to appropriate public authorities, and to
p.000745: health officials and scientists engaged in special study;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
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p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
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p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
...

p.000871: underage drinking problem and patterns of underage alcohol consumption, including improved knowledge
p.000871: about the problem and progress in preventing, reduc- ing and treating underage drinking; as well as
p.000871: infor- mation on the rate of exposure of youth to advertising and other media messages encouraging and discour-
p.000871: aging alcohol consumption.
p.000871: (iii) Compiling information on the involvement of alcohol in unnatural deaths of persons ages 12 to 20
p.000871: in the United States, including suicides, homicides, and unintentional injuries such as falls, drownings,
p.000871: burns, poisonings, and motor vehicle crash deaths.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: Sec. 519B PUBLIC HEALTH SERVICE ACT 872
p.000871:
p.000871: (B) CERTAIN MATTERS.—The Secretary shall carry out activities toward the following objectives with respect
p.000871: to underage drinking:
p.000871: (i) Obtaining new epidemiological data within the national or targeted surveys that identify alcohol use
p.000871: and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a
p.000871: result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol
p.000871: exposure.
p.000871: (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
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p.000875: 875
p.000875: PUBLIC HEALTH SERVICE ACT
p.000875: Sec. 520
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p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
p.000875: (9) carry out the programs under part C;
p.000875: (10) carry out responsibilities for the Human Resource De- velopment program, and programs of clinical
p.000875: training for health paraprofessional personnel and health professionals;
...

p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
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p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
p.000939: SEC. 581. 19 ø290hh¿ CHILDREN AND VIOLENCE.
p.000939: (a) IN GENERAL.—The Secretary, in consultation with the Sec- retary of Education and the Attorney General, shall
p.000939: carry out di- rectly or through grants, contracts or cooperative agreements with public entities a program to assist
p.000939: local communities in developing ways to assist children in dealing with violence.
p.000939: (b) ACTIVITIES.—Under the program under subsection (a), the Secretary may—
p.000939: (1) provide financial support to enable local communities to implement programs to foster the health and
p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
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p.000939: 19 There is another part G in this title, which also begins with a section 581. See page 677. That
p.000939: part G relates to services provided through religious organizations.
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: (a) will be distributed equitably among the regions of the country and among urban and rural areas.
p.000939: (e) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000939: period during which payments under such an award will be made to the recipient may not exceed 5 years.
p.000939: (f) EVALUATION.—The Secretary shall conduct an evaluation of each project carried out under this section and
p.000939: shall disseminate the results of such evaluations to appropriate public and private entities.
p.000939: (g) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000939: programs to dissemi- nate the findings of the knowledge development and application under this section to
p.000939: the general public and to health care profes- sionals.
p.000939: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000939: $100,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and
p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
p.000939: (2) the development of knowledge with regard to evidence- based practices for identifying and treating mental,
p.000939: behavioral, and biological disorders of children and youth resulting from witnessing or experiencing a
p.000939: traumatic event.
p.000939: (b) PRIORITIES.—In awarding grants, contracts or cooperative agreements under subsection (a)(2) (related to
p.000939: the development of knowledge on evidence-based practices for treating mental, behav- ioral, and biological
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p.000947: subpart II of part B of title XIX (relating to formula grants to the States).
p.000947: (b) LIMITATION.—This part does not apply to any award of fi- nancial assistance under a designated program
p.000947: for a purpose other than the purpose specified in subsection (a).
p.000947: (c) DEFINITIONS.—For purposes of this part (and subject to sub- section (b)):
p.000947: (1) The term ‘‘designated program’’ has the meaning given such term in subsection (a).
p.000947: (2) The term ‘‘financial assistance’’ means a grant, coopera- tive agreement, or contract.
p.000947: (3) The term ‘‘program beneficiary’’ means an individual who receives program services.
p.000947: (4) The term ‘‘program participant’’ means a public or pri- vate entity that has received financial assistance under a
p.000947: des- ignated program.
p.000947: (5) The term ‘‘program services’’ means treatment for sub- stance abuse, or preventive services regarding such abuse,
p.000947: pro- vided pursuant to an award of financial assistance under a designated program.
p.000947: (6) The term ‘‘religious organization’’ means a nonprofit re- ligious organization.
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p.000947: January 30, 2020
p.000947: 22 There are two parts G in this title. The first was added by section 3101 of Public Law 106– 310 (114 Stat. 1168) and
p.000947: relates to projects for children and violence; that part also begins with section 581. See page 669. Sections
p.000947: 3207 and 3208 of such Public Law (114 Stat. 1195, 1197) added parts H and I, respectively.
p.000947: Subsequently, part G above was added by section 144 of the Community Renewal Tax Relief Act of 2000 (as enacted
p.000947: into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A– 619), which provides that title V
p.000947: of this Act ‘‘is amended by adding at the end the following part:’’, thereby placing that part G after the
p.000947: part I added by Public Law 106–310.
p.000947: 23 Section 1955 of this Act also relates to religious organizations as providers of substance abuse
p.000947: services. That section was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.000947: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: Sec. 831 PUBLIC HEALTH SERVICE ACT 1092
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
p.001091: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to paragraph
p.001091: (1) or (2).
p.001091: (1) GRANTS FOR CAREER LADDER PROGRAMS.—The Sec- retary may award grants to and enter into contracts
p.001091: with eligi- ble entities for programs—
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p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001123:
p.001123:
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p.001123: Sec. 917 PUBLIC HEALTH SERVICE ACT 1124
p.001123:
p.001123: the victims referred to in paragraph (1), and of other appro- priate public and private entities
p.001123: (including medical societies, victim services organizations, sexual assault prevention organi- zations, and social
p.001123: services organizations).
p.001123: SEC. 917. ø299b–6¿ COORDINATION OF FEDERAL GOVERNMENT QUAL- ITY IMPROVEMENT EFFORTS.
p.001123: (a) REQUIREMENT.—
p.001123: (1) IN GENERAL.—To avoid duplication and ensure that Federal resources are used efficiently and
p.001123: effectively, the Sec- retary, acting through the Director, shall coordinate all re- search, evaluations, and
p.001123: demonstrations related to health serv- ices research, quality measurement and quality improvement activities
p.001123: undertaken and supported by the Federal Govern- ment.
p.001123: (2) SPECIFIC ACTIVITIES.—The Director, in collaboration with the appropriate Federal officials
p.001123: representing all con- cerned executive agencies and departments, shall develop and manage a process to—
...

p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
p.001191: appropriated is greater than
p.001191: $1,000,000, 50 percent of such appropriation shall be made avail- able for the purpose of carrying out part A
p.001191: and 50 percent shall be made available for the purpose of carrying out part B.
p.001191: (c) ALLOCATION OF PART A FUNDS.—Of the amounts appro- priated under subsection (a) for a fiscal year to carry
p.001191: out part A—
p.001191: (1) 10 percent of such amounts for such year shall be allo- cated for administrative purposes; and
p.001191: (2) 10 percent of such amounts for such year shall be allo- cated for the purpose of carrying out section 1202.
p.001191: (d) AUTHORITY.—For the purpose of carrying out parts A through C, beginning on the date of enactment of
p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
p.001191: (3) to provide emergency relief to ensure the continued and future availability of trauma services.
p.001191: (b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS.—
p.001191: (1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—Except as
p.001191: pro- vided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a)
...

p.001195: C:\XML\PHSA.BEL HOUSEP
p.001195:
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p.001195:
p.001195: Sec. 1246 PUBLIC HEALTH SERVICE ACT 1196
p.001195:
p.001195: other authorization of appropriations or amounts that are available for such purpose.
p.001195: SEC. 1246. ø300d–46¿ DEFINITION.
p.001195: In this part, the term ‘‘uncompensated care costs’’ means unre- imbursed costs from serving self-pay, charity, or
p.001195: Medicaid patients, without regard to payment under section 1923 of the Social Secu- rity Act, all of which
p.001195: are attributable to emergency care and trau- ma care, including costs related to subsequent inpatient admissions to the
p.001195: hospital.
p.001195: Part E—Miscellaneous Programs
p.001195:
p.001195:
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p.001195:
p.001195:
p.001195: January 30, 2020
p.001195: SEC. 1251. ø300d–51¿ RESIDENCY TRAINING PROGRAMS IN EMER- GENCY MEDICINE.
p.001195: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001195: of planning and de- veloping approved residency training programs in emergency medi- cine.
p.001195: (b) IDENTIFICATION AND REFERRAL OF DOMESTIC VIOLENCE.— The Secretary may make a grant under subsection
p.001195: (a) only if the applicant involved agrees that the training programs under sub- section (a) will provide
p.001195: education and training in identifying and referring cases of domestic violence.
p.001195: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001195: to be appropriated
p.001195: $400,000 for each of the fiscal years 2008 though 2012.
p.001195: SEC. 1252. ø300d–52¿ STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC BRAIN INJURY.
p.001195: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001195: Living, may make grants to States and American Indian consortia for the purpose of carrying out projects
p.001195: to improve access to rehabilitation and other services regarding traumatic brain injury.
p.001195: (b) STATE ADVISORY BOARD.—
p.001195: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the State or American Indian
p.001195: consortium involved agrees to establish an advisory board within the ap- propriate health department of
p.001195: the State or American Indian consortium or within another department as designated by the chief executive officer
p.001195: of the State or American Indian consor- tium.
p.001195: (2) FUNCTIONS.—An advisory board established under paragraph (1) shall advise and make recommendations
p.001195: to the State or American Indian consortium on ways to improve serv- ices coordination regarding traumatic brain
p.001195: injury. Such advi- sory boards shall encourage citizen participation through the establishment of public
p.001195: hearings and other types of community outreach programs. In developing recommendations under this paragraph, such
...

p.001201: (A) engaging stakeholders, including victims of human trafficking and Federal, State, local, and tribal partners, to
p.001201: develop a flexible training module—
p.001201: (i) for supporting activities under subsection (c);
p.001201: and
p.001201: (ii) that adapts to changing needs, settings, health
p.001201:
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p.001201:
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p.001201:
p.001201:
p.001201:
p.001201: January 30, 2020
p.001201: care providers, and social service providers;
p.001201: (B) providing technical assistance to grantees related to implementing activities described in subsection
p.001201: (c) and reporting on any best practices identified by the grantees;
p.001201: (C) developing a reliable methodology for collecting data, and reporting such data, on the number of
p.001201: human trafficking victims identified and served by grantees in a manner that, at a minimum, prevents
p.001201: disclosure of indi- vidually identifiable information consistent with all appli- cable privacy laws and
p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001201:
p.001201:
p.001201:
p.001201:
p.001201:
...

p.001277:
p.001277:
p.001277:
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p.001277:
p.001277:
p.001277: January 30, 2020
p.001277: (1) coordinate all activities within the Department of Health and Human Services that relate to
p.001277: disease prevention, health promotion, preventive health services, and health infor- mation and education with
p.001277: respect to the appropriate use of health care, including coordinating—
p.001277: (A) the design of programs, support for programs, and the evaluation of programs;
p.001277: (B) the monitoring of trends;
p.001277: (C) projects of research (including multidisciplinary projects) on adolescent health; and
p.001277: (D) the training of health providers who work with adolescents, particularly nurse practitioners, physician as-
p.001277: sistants, and social workers;
p.001277: (2) coordinate the activities described in paragraph (1) with similar activities in the private sector; and
p.001277: (3) support projects, conduct research, and disseminate in- formation relating to preventive medicine, health
p.001277: promotion, and physical fitness and sports medicine.
p.001277: (c) CERTAIN DEMONSTRATION PROJECTS.—
p.001277: (1) IN GENERAL.—In carrying out subsection (b)(3), the Sec- retary may make grants to carry out demonstration projects
p.001277: for the purpose of improving adolescent health, including projects to train health care providers in
p.001277: providing services to adoles- cents and projects to reduce the incidence of violence among adolescents,
p.001277: particularly among minority males.
p.001277: (2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there are authorized to be
p.001277: appro- priated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994
p.001277: through 1997.
p.001277: (d) INFORMATION CLEARINGHOUSE.—In carrying out subsection (b), the Secretary shall establish and maintain a
p.001277: National Informa- tion Clearinghouse on Adolescent Health to collect and disseminate to health professionals and
p.001277: the general public information on ado- lescent health.
p.001277: (e) NATIONAL PLAN.—In carrying out subsection (b), the Sec- retary shall develop a national plan
p.001277: for improving adolescent health. The plan shall be consistent with the applicable objectives established
p.001277: by the Secretary for the health status of the people of the United States for the year 2000, and
p.001277: shall be periodically re- viewed, and as appropriate, revised. The plan, and any revisions in the plan, shall be
p.001277: submitted to the Committee on Energy and Com- merce of the House of Representatives and the Committee on Labor and
p.001277: Human Resources of the Senate.
p.001277: (f) ADOLESCENT HEALTH.—For purposes of this section, the term ‘‘adolescent health’’, with respect to
p.001277: adolescents of all ethnic
p.001277: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001277:
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p.001549: from those described in such paragraph, to address adverse se- lection as approved by the State insurance commissioner
p.001549: or of- ficial or officials designated by the State to enforce the require- ments of this part for the State
p.001549: involved with respect to such issuer.
p.001549: SEC. 2705. ø300gg–4¿ PROHIBITING DISCRIMINATION AGAINST INDI- VIDUAL PARTICIPANTS AND BENEFICIARIES BASED ON
p.001549: HEALTH STATUS.
p.001549: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001549: coverage may not establish rules for eligibility (including continued eligibility) of any individual to enroll
p.001549: under the terms of the plan or coverage based on any of the following health status-related factors in rela-
p.001549: tion to the individual or a dependent of the individual:
p.001549: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001549:
p.001549:
p.001549:
p.001549:
p.001549:
p.001549:
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p.001549:
p.001549: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1550
p.001549:
p.001549: (1) Health status.
p.001549: (2) Medical condition (including both physical and mental illnesses).
p.001549: (3) Claims experience.
p.001549: (4) Receipt of health care.
p.001549: (5) Medical history.
p.001549: (6) Genetic information.
p.001549: (7) Evidence of insurability (including conditions arising out of acts of domestic violence).
p.001549: (8) Disability.
p.001549: (9) Any other health status-related factor determined ap- propriate by the Secretary.
p.001549: (b) IN PREMIUM CONTRIBUTIONS.—
p.001549: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001549: insurance cov- erage, may not require any individual (as a condition of enroll- ment or continued enrollment under
p.001549: the plan) to pay a pre- mium or contribution which is greater than such premium or contribution for a
p.001549: similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to
p.001549: the individual or to an individual enrolled under the plan as a dependent of the individual.
p.001549: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued—
p.001549:
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p.001549: January 30, 2020
p.001549: (A) to restrict the amount that an employer or indi- vidual may be charged for coverage under a group
p.001549: health plan except as provided in paragraph (3) or individual health coverage, as the case may be; or
p.001549: (B) to prevent a group health plan, and a health insur- ance issuer offering group health insurance coverage, from
p.001549: establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in
p.001549: return for adherence to programs of health promotion and disease prevention.
...

Searching for indicator union:

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p.000991: instrument evi- dencing a loan which has been insured by him under this sub- part (including modifications with
p.000991: respect to the rate of inter- est, time of payment of any installment of principal and inter- est or any portion
p.000991: thereof, or any other provision).
p.000991: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000991:
p.000991:
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p.000991:
p.000991:
p.000993: 993
p.000993: PUBLIC HEALTH SERVICE ACT
p.000993: Sec. 715
p.000993:
p.000993: (5) To enforce, pay, compromise, waive, or release any right, title, claim, lien, or demand, however acquired,
p.000993: including any equity or any right or 2 redemption.
p.000993: (b) ANNUAL BUDGET; ACCOUNTS.—The Secretary shall, with re- spect to the financial operations arising by reason of this
p.000993: subpart—
p.000993: (1) prepare annually and submit a budget program as pro- vided for wholly owned Government corporations by the
p.000993: Gov- ernment Corporation Control Act; and
p.000993: (2) maintain with respect to insurance under this subpart an integral set of accounts.
p.000993: SEC. 712. ø292k¿ PARTICIPATION BY FEDERAL CREDIT UNIONS IN FED- ERAL, STATE, AND PRIVATE STUDENT LOAN INSURANCE
p.000993: PROGRAMS.
p.000993: Notwithstanding any other provision of law, Federal credit unions shall, pursuant to regulations of the
p.000993: Administrator of the National Credit Union Administration, have power to make in- sured loans to eligible
p.000993: students in accordance with the provisions of this subpart relating to Federal insured loans.
p.000993: SEC. 713. ø292l¿ DETERMINATION OF ELIGIBLE STUDENTS.
p.000993: For purposes of determining eligible students under this part, in the case of a public school in a State that
p.000993: offers an accelerated, integrated program of study combining undergraduate premedical education and medical
p.000993: education leading to advanced entry, by con- tractual agreement, into an accredited four-year school of medicine which
p.000993: provides the remaining training leading to a degree of doctor of medicine, whenever in this part a provision
p.000993: refers to a student at a school of medicine, such reference shall include only a student enrolled in any of the last
p.000993: four years of such accelerated, integrated program of study.
p.000993: SEC. 714. ø292m¿ REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR DISABLED BORROWERS.
p.000993: If a borrower who has received a loan dies or becomes perma- nently and totally disabled (as determined in accordance
p.000993: with regu- lations of the Secretary), the Secretary shall discharge the bor- rower’s liability on the loan
p.000993: by repaying the amount owed on the loan from the account established under section 710.
p.000993: SEC. 715. ø292n¿ ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.
p.000993: (a) IN GENERAL.—Notwithstanding any other provision of this subpart, the Secretary is authorized to
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Searching for indicator unemployment:

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p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
p.001341:
p.001341:
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Searching for indicator trauma:

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p.000169: section 2802;
p.000169: (C) a description of amounts received by eligible enti- ties described in subsection (b) and section 319C–2(b),
p.000169: and amounts received by subrecipients and the effect of such funding on meeting evidence-based benchmarks and
p.000169: objec- tive standards; and
p.000169: (D) recommendations, as applicable and appropriate, to improve evidence-based benchmarks and objective
p.000169: standards to more accurately assess the ability of entities receiving awards under this section to better
p.000169: achieve the goals under this section and section 2802.
p.000169: SEC. 319C–2. ø247d–3b¿ PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS TO IMPROVE SURGE CAPAC-
p.000169: ITY.
p.000169: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall award
p.000169: competitive grants or cooperative agreements to eligible entities to enable such entities to improve surge capacity
p.000169: and enhance community and hospital preparedness for, and response to, public health emer- gencies in
p.000169: accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of
p.000169: children and other at-risk individuals.
p.000169: (b) ELIGIBILITY.—To be eligible for an award under subsection (a), an entity shall—
p.000169: (1)(A) be a coalition that includes—
p.000169: (i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with
p.000169: section 1213(c);
p.000169: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000169:
p.000169:
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p.000171: 171
p.000171: PUBLIC HEALTH SERVICE ACT
p.000171: Sec. 319C–2
p.000171:
p.000171: (ii) one or more other local health care facilities, in- cluding clinics, health centers, community
p.000171: health centers, primary care facilities, mental health centers, mobile med- ical assets, or nursing homes;
p.000171: (iii)(I) one or more political subdivisions;
p.000171: (II) one or more States; or
p.000171: (III) one or more States and one or more political sub- divisions; and
p.000171: (iv) one or more emergency medical service organiza- tions or emergency management organizations; and
p.000171: (B) prepare, in consultation with the Chief Executive Offi- cer and the lead health officials of the State, District,
p.000171: or terri- tory in which the hospital and health care facilities described in subparagraph (A) are located,
p.000171: and submit to the Secretary, an application at such time, in such manner, and containing such information
p.000171: as the Secretary may require; or
p.000171: (2)(A) be an entity described in section 319C–1(b)(1); and
p.000171: (B) submit an application at such time, in such manner, and containing such information as the Secretary may
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p.000173: following a public health emergency, including threats posed by one or more chem- ical, biological,
p.000173: radiological, or nuclear agents, including emerging infectious diseases.
p.000173: (b) GUIDELINES.—The Assistant Secretary for Preparedness and Response, in consultation with the Director of
p.000173: the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid
p.000173: Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and
p.000173: Drugs, the Assistant Secretary for Mental Health and Sub- stance Use, the Assistant Secretary of Labor for
p.000173: Occupational Safe- ty and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as
p.000173: the Secretary determines to be appro- priate, and State, local, Tribal, and territorial public health
p.000173: offi- cials, shall, not later than 2 years after the date of enactment of this section—
p.000173: (1) identify and develop a set of guidelines relating to prac- tices and protocols for all-hazards public health
p.000173: emergency pre- paredness and response for hospitals and health care facilities to provide appropriate patient care
p.000173: during, in advance of, or immediately following, a public health emergency, resulting from one or more
p.000173: chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may in-
p.000173: clude existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—
p.000173: (A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and
p.000173: ca- pacity to treat patients affected by such emergency, includ- ing—
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p.000173: (i) the manner in which the system will coordinate with and integrate the partnerships and health care
p.000173: coalitions established under section 319C–2(b); and
p.000173: (ii) informing and educating appropriate first re- sponders and health care supply chain partners of the regional
p.000173: emergency preparedness and response capa- bilities and medical surge capacity of such hospitals and health
p.000173: care facilities in the community;
p.000173: (B) physical and technological infrastructure, labora- tory capacity, staffing, blood supply, and
p.000173: other supply chain needs, taking into account resiliency, geographic con- siderations, and rural considerations;
p.000173: (C) protocols or best practices for the safety and per- sonal protection of workers who handle human
p.000173: remains
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p.000175: (2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner
p.000175: that does not compromise national security; and
p.000175: (3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and
p.000175: infor- mation resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and
p.000175: Advancing Inno- vation Act of 2019 (including any amendments made by such Act), to address new and emerging
p.000175: public health threats.
p.000175: (c) CONSIDERATIONS.—In identifying, developing, and updating guidelines under subsection (b), the Assistant
p.000175: Secretary for Pre- paredness and Response shall—
p.000175: (1) include input from hospitals and health care facilities (including health care coalitions under
p.000175: section 319C–2), State, local, Tribal, and territorial public health departments, and health care or
p.000175: subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or
p.000175: nu- clear threats, including emerging infectious diseases), as the Assistant Secretary determines
p.000175: appropriate, to meet the goals under section 2802(b)(3);
p.000175: (2) consult and engage with appropriate health care pro- viders and professionals, including physicians,
p.000175: nurses, first re- sponders, health care facilities (including hospitals, primary care clinics, community health
p.000175: centers, mental health facilities, ambulatory care facilities, and dental health facilities), phar- macies,
p.000175: emergency medical providers, trauma care providers, environmental health agencies, public health laboratories,
p.000175: poi- son control centers, blood banks, tissue banks, and other ex- perts that the Assistant Secretary
p.000175: determines appropriate, to meet the goals under section 2802(b)(3);
p.000175: (3) consider feedback related to financial implications for hospitals, health care facilities, public
p.000175: health agencies, labora- tories, blood banks, tissue banks, and other entities engaged in regional preparedness
p.000175: planning to implement and follow such guidelines, as applicable; and
p.000175: (4) consider financial requirements and potential incen- tives for entities to prepare for, and respond
p.000175: to, public health emergencies as part of the regional health care emergency pre- paredness and response system.
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000175:
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p.000175: Sec. 319D PUBLIC HEALTH SERVICE ACT 176
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p.000453: Network and other appropriate organizations, shall support the development and dissemination of educational
p.000453: materials to inform health care pro- fessionals and other appropriate professionals in issues sur-
p.000453: rounding organ, tissue, and eye donation including evidence-based proven methods to approach patients and
p.000453: their families, cultural sensitivities, and other relevant issues.
p.000453: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000453: to be appropriated
p.000453: $15,000,000 for fiscal year 2005, and such sums as may be nec- essary for each of the fiscal years 2006
p.000453: through 2009. Such author- ization of appropriations is in addition to any other authorizations of appropriations that
p.000453: are available for such purpose.
p.000453: SEC. 377B. ø274f–2¿ GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.
p.000453: (a) AUTHORITY.—
p.000453: (1) IN GENERAL.—The Secretary may award grants to qualified organ procurement organizations and hospitals
p.000453: under section 371 to establish programs coordinating organ donation activities of eligible hospitals and
p.000453: qualified organ procurement organizations under section 371. Such activities shall be coordi- nated to increase the
p.000453: rate of organ donations for such hos- pitals.
p.000453: (2) ELIGIBLE HOSPITAL.—For purposes of this section, the term ‘‘eligible hospital’’ means a hospital that
p.000453: performs signifi- cant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer
p.000453: than 200,000 individuals.
p.000453: (b) ADMINISTRATION OF COORDINATION PROGRAM.—A condition for the receipt of a grant under subsection (a) is that
p.000453: the applicant involved agree that the program under such subsection will be car- ried out jointly—
p.000453: (1) by representatives from the eligible hospital and the qualified organ procurement organization with
p.000453: respect to which the grant is made; and
p.000453: (2) by such other entities as the representatives referred to in paragraph (1) may designate.
p.000453: (c) REQUIREMENTS.—Each entity receiving a grant under sub- section (a) shall—
p.000453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000455: PUBLIC HEALTH SERVICE ACT
p.000455: Sec. 377C
p.000455:
p.000455: (1) establish joint organ procurement organization and hospital designated leadership responsibility
p.000455: and account- ability for the project;
p.000455: (2) develop mutually agreed upon overall project perform- ance goals and outcome measures, including
p.000455: interim outcome targets; and
p.000455: (3) collaboratively design and implement an appropriate data collection process to provide ongoing feedback
p.000455: to hospital and organ procurement organization leadership on project progress and results.
p.000455: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to interfere with regulations in
...

p.000475: Control and Pre- vention, may carry out projects to reduce the incidence of traumatic brain injury. Such projects
p.000475: may be carried out by the Secretary di- rectly or through awards of grants or contracts to public or non-
p.000475: profit private entities. The Secretary may directly or through such awards provide technical assistance with
p.000475: respect to the planning, development, and operation of such projects.
p.000475: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000475: (1) the conduct of research into identifying effective strate- gies for the prevention of traumatic brain injury;
p.000475: (2) the implementation of public information and education programs for the prevention of such injury and for
p.000475: broadening the awareness of the public concerning the public health con- sequences of such injury; and
p.000475: (3) the implementation of a national education and aware- ness campaign regarding such injury (in conjunction
p.000475: with the program of the Secretary regarding health-status goals for 2020, commonly referred to as Healthy
p.000475: People 2020), includ- ing—
p.000475: (A) the national dissemination of information on—
p.000475: (i) incidence and prevalence; and
p.000475: (ii) information relating to traumatic brain injury and the sequelae of secondary conditions arising from
p.000475: traumatic brain injury upon discharge from hospitals and emergency departments; and
p.000475: (B) the provision of information in primary care set- tings, including emergency rooms and trauma centers, con-
p.000475: cerning the availability of State level services and re- sources.
p.000475: (c) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.000475: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities regarding
p.000475: traumatic brain injury.
p.000475: (d) DEFINITION.—For purposes of this section, the term ‘‘trau- matic brain injury’’ means an acquired
p.000475: injury to the brain. Such term does not include brain dysfunction caused by congenital or de- generative disorders,
p.000475: nor birth trauma, but may include brain inju- ries caused by anoxia due to trauma. The Secretary may revise the
p.000475: definition of such term as the Secretary determines necessary, after consultation with States and other
p.000475: appropriate public or nonprofit private entities.
p.000475:
p.000475:
p.000475:
p.000475: January 30, 2020 As Amended Through P.L. 116-94,
p.000475: Enacted December 20, 2019
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p.000475: Sec. 393C PUBLIC HEALTH SERVICE ACT 476
p.000475:
p.000475: NATIONAL PROGRAM FOR TRAUMATIC BRAIN INJURY SURVEILLANCE AND REGISTRIES
p.000475: SEC. 393C. 88 ø280b–1d¿ (a) IN GENERAL.—The Secretary, act- ing through the Director of the Centers for
p.000475: Disease Control and Prevention, may make grants to States or their designees to de- velop or operate the
p.000475: State’s traumatic brain injury surveillance sys- tem or registry to determine the incidence and prevalence of trau-
p.000475: matic brain injury and related disability, to ensure the uniformity of reporting under such system or
p.000475: registry, to link individuals with traumatic brain injury to services and supports, and to link such
p.000475: individuals with academic institutions to conduct applied research that will support the development of such
p.000475: surveillance systems and registries as may be necessary. A surveillance system or registry under this
p.000475: section shall provide for the collection of data con- cerning—
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p.000541: includes at least one of each of—
p.000541: (I) an accredited school of allopathic or osteo- pathic medicine, psychology, nursing, dentistry, social
p.000541: work, or other health field;
p.000541: (II) a health care facility or system; or
p.000541: (III) a government or nonprofit entity with a history of effective work in the fields of domestic
p.000541: violence, dating violence, sexual assault, or stalk- ing; and
p.000541: (ii) strategies for the dissemination and sharing of curricula and other educational materials developed under
p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
p.000541: nonprofit victim advocacy organizations, State or trib- al law enforcement task forces (where appropriate), and
p.000541: population specific organizations with dem- onstrated expertise in domestic violence, dating vio-
p.000541: lence, sexual assault, or stalking;
p.000541: (iv) with respect to an application for a grant under which the grantee will have contact with pa-
p.000541: tients, a plan, developed in collaboration with local victim service providers, to respond appropriately
p.000541: to and make correct referrals for individuals who disclose that they are victims of domestic violence, dating
p.000541: vio- lence, sexual assault, stalking, or other types of vio- lence, and documentation provided by the
p.000541: grantee of an ongoing collaborative relationship with a local vic- tim service provider; and
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000541:
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p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
p.000577: the eligible entity agrees, with respect to the costs to be incurred by the eligible enti- ty in carrying out the
p.000577: activities described in subsection (d), to make available non-Federal contributions (in cash or in kind) toward
p.000577: such costs in an amount that is not less than 10 percent of the total amount of Federal funds provided in
p.000577: the grant.
p.000577: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000577: $20,000,000 for the period of fiscal years 2018 through 2022.
p.000577: PART R—PROGRAMS RELATING TO AUTISM
p.000577:
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p.000577:
p.000577: January 30, 2020
p.000577: SEC. 399AA. ø280i¿ DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH PROGRAM.
p.000577: (a) AUTISM SPECTRUM DISORDER AND OTHER DEVELOPMENTAL DISABILITIES.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
...

p.000939: (f) EVALUATION.—The Secretary shall conduct an evaluation of each project carried out under this section and
p.000939: shall disseminate the results of such evaluations to appropriate public and private entities.
p.000939: (g) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000939: programs to dissemi- nate the findings of the knowledge development and application under this section to
p.000939: the general public and to health care profes- sionals.
p.000939: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000939: $100,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and
p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
p.000939: (2) the development of knowledge with regard to evidence- based practices for identifying and treating mental,
p.000939: behavioral, and biological disorders of children and youth resulting from witnessing or experiencing a
p.000939: traumatic event.
p.000939: (b) PRIORITIES.—In awarding grants, contracts or cooperative agreements under subsection (a)(2) (related to
p.000939: the development of knowledge on evidence-based practices for treating mental, behav- ioral, and biological
p.000939: disorders associated with psychological trau- ma), the Secretary shall give priority to universities,
p.000939: hospitals, mental health agencies, and other programs that have established clinical expertise and research
p.000939: experience in the field of trauma-re- lated mental disorders.
p.000939: (c) CHILD OUTCOME DATA.—The NCTSI coordinating center de- scribed in subsection (a)(1) shall collect, analyze, report,
p.000939: and make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding
p.000939: the early identification and de- livery of evidence-based treatment and services for children and families
p.000939: served by the NCTSI grantees.
p.000939: (d) TRAINING.—The NCTSI coordinating center shall facilitate the coordination of training initiatives in
p.000939: evidence-based and trau-
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000941: PUBLIC HEALTH SERVICE ACT
p.000941: Sec. 591
p.000941:
p.000941: ma-informed treatments, interventions, and practices offered to NCTSI grantees, providers, and partners.
p.000941: (e) DISSEMINATION AND COLLABORATION.—The NCTSI coordi- nating center shall, as appropriate, collaborate with—
p.000941: (1) the Secretary, in the dissemination of evidence-based and trauma-informed interventions, treatments,
p.000941: products, and other resources to appropriate stakeholders; and
p.000941: (2) appropriate agencies that conduct or fund research within the Department of Health and Human Services, for
p.000941: pur- poses of sharing NCTSI expertise, evaluation data, and other activities, as appropriate.
p.000941: (f) REVIEW.—The Secretary shall, consistent with the peer-re- view process, ensure that NCTSI applications
p.000941: are reviewed by ap- propriate experts in the field as part of a consensus-review process. The Secretary shall
p.000941: include review criteria related to expertise and experience in child trauma and evidence-based practices.
p.000941: (g) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative
p.000941: agreements under subsection
p.000941: (a) are distributed equitably among the regions of the United States and among urban and rural areas.
p.000941: (h) EVALUATION.—The Secretary, as part of the application process, shall require that each applicant for
p.000941: a grant, contract or cooperative agreement under subsection (a) submit a plan for the rigorous evaluation
p.000941: of the activities funded under the grant, con- tract or agreement, including both process and outcomes
p.000941: evalua- tion, and the submission of an evaluation at the end of the project period.
p.000941: (i) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000941: period during which payments under such an award will be made to the recipient shall not be less than 4 years,
p.000941: but shall not exceed 5 years. Such grants, contracts or agreements may be renewed.
p.000941: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000941: $63,887,000 for each of fiscal years 2019 through 2023.
p.000941: (k) SHORT TITLE.—This section may be cited as the ‘‘Donald J. Cohen National Child Traumatic Stress Initiative’’.
p.000941:
p.000941: PART H—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN FACILI- TIES
p.000941:
p.000941:
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p.000941: January 30, 2020
p.000941: SEC. 591. ø290ii¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN FACILITIES.
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p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001023:
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p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
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p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: 1047
p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
p.001047:
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p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
p.001047: inter- disciplinary training of social work graduate students for pro- viding behavioral health services,
p.001047: including trauma-informed care and substance use disorder prevention and treatment services, and the
p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
...

p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
p.001053: dis- tribution of mental and substance use disorders services;
p.001053: (B) an analysis of the effect of the demonstration pro- gram on the prevalence of untreated mental and substance
...

p.001177: centers already engaged in the production of blood fractions could alleviate such insufficiency with
p.001177: assistance under this subsection, he may make grants not to exceed $500,000 to such centers for the purposes of
p.001177: alleviating the insufficiency.
p.001177: (c) No grant or contract may be made under subsection (a) or
p.001177: (b) unless an application therefor has been submitted to and ap- proved by the Secretary. Such an application
p.001177: shall be in such form, submitted in such manner, and contain such information as the Secretary shall by
p.001177: regulation prescribe.
p.001177: (d) Contracts may be entered into under subsection (a) without regard to section 3648 and 3709 of the Revised Statutes
p.001177: (31 U.S.C. 529; 41 U.S.C. 5).
p.001177: (e) For the purpose of making payments under grants and con- tracts under subsections (a) and (b), there are authorized
p.001177: to be ap- propriated $4,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977,
p.001177: $3,450,000 for the fiscal year end- ing September 30, 1978, $2,500,000 for the fiscal year ending Sep- tember 30,
p.001177: 1979, $3,000,000 for the fiscal year ending September 30, 1980, $3,500,000 for the fiscal year ending September
p.001177: 30, 1981.
p.001177: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: 1179
p.001179: PUBLIC HEALTH SERVICE ACT
p.001179: Sec. 1202
p.001179:
p.001179: TITLE XII—TRAUMA CARE
p.001179: PART A—GENERAL AUTHORITY AND DUTIES OF SECRETARY
p.001179: SEC. 1201. ø300d¿ ESTABLISHMENT.
p.001179: (a) IN GENERAL.—The Secretary shall, with respect to trauma care—
p.001179: (1) conduct and support research, training, evaluations, and demonstration projects;
p.001179: (2) foster the development of appropriate, modern systems of such care through the sharing of information among
p.001179: agen- cies and individuals involved in the study and provision of such care;
p.001179: (3) collect, compile, and disseminate information on the achievements of, and problems experienced by, State and
p.001179: local agencies and private entities in providing trauma care and emergency medical services and, in so
p.001179: doing, give special con- sideration to the unique needs of rural areas;
p.001179: (4) provide to State and local agencies technical assistance to enhance each State’s capability to develop,
p.001179: implement, and sustain the trauma care component of each State’s plan for the provision of emergency medical services;
p.001179: (5) sponsor workshops and conferences; and
p.001179: (6) promote the collection and categorization of trauma data in a consistent and standardized manner.
p.001179: (b) GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS.—The Secretary may make grants, and enter into cooperative
p.001179: agreements and contracts, for the purpose of carrying out subsection (a).
p.001179: SEC. 1202. ø300d–3¿ ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE IN RURAL AREAS.
p.001179: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001179: of carrying out re- search and demonstration projects with respect to improving the availability and
p.001179: quality of emergency medical services in rural areas—
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p.001179: (1) by developing innovative uses of communications tech- nologies and the use of new communications technology;
p.001179: (2) by developing model curricula, such as advanced trau- ma life support, for training emergency medical
p.001179: services per- sonnel, including first responders, emergency medical techni- cians, emergency nurses and
p.001179: physicians, and paramedics—
p.001179: (A) in the assessment, stabilization, treatment, prepa- ration for transport, and resuscitation of seriously
p.001179: injured patients, with special attention to problems that arise dur- ing long transports and to methods of
p.001179: minimizing delays in transport to the appropriate facility; and
p.001179: (B) in the management of the operation of the emer- gency medical services system;
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p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
p.001179: (6) by increasing communication and coordination with State trauma systems.
p.001179: (b) SPECIAL CONSIDERATION FOR CERTAIN RURAL AREAS.—In making grants under subsection (a), the
p.001179: Secretary shall give spe- cial consideration to any applicant for the grant that will provide services
p.001179: under the grant in any rural area identified by a State under section 1214(d)(1).
p.001179: (c) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.001179: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001179: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: 1181
p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001181: (d) PRIORITY.—In making grants under this section, the Sec- retary shall give priority to applicants that
p.001181: will use the grants to focus on improving access to trauma care systems.
p.001181: (e) SPECIAL CONSIDERATION.—In awarding grants under this section, the Secretary shall give special
p.001181: consideration to projects that demonstrate strong State or local support, including avail- ability of
p.001181: non-Federal contributions.
p.001181: SEC. 1204. ø300d–6¿ COMPETITIVE GRANTS FOR REGIONALIZED SYS- TEMS FOR EMERGENCY CARE RESPONSE.
p.001181: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall
p.001181: award not fewer than 4 multiyear contracts or competitive grants to eligible entities to support pilot projects that
p.001181: design, implement, and evaluate inno- vative models of regionalized, comprehensive, and accountable
p.001181: emergency care and trauma systems.
p.001181: (b) ELIGIBLE ENTITY; REGION.—In this section:
p.001181: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means—
p.001181: (A) a State or a partnership of 1 or more States and 1 or more local governments; or
p.001181: (B) an Indian tribe (as defined in section 4 of the In- dian Health Care Improvement Act) or a
p.001181: partnership of 1 or more Indian tribes.
p.001181: (2) REGION.—The term ‘‘region’’ means an area within a State, an area that lies within multiple States,
p.001181: or a similar area (such as a multicounty area), as determined by the Sec- retary.
p.001181: (3) EMERGENCY SERVICES.—The term ‘‘emergency services’’ includes acute, prehospital, and trauma care.
p.001181: (c) PILOT PROJECTS.—The Secretary shall award a contract or grant under subsection (a) to an eligible entity
p.001181: that proposes a pilot project to design, implement, and evaluate an emergency medical and trauma system that—
p.001181: (1) coordinates with public health and safety services, emergency medical services, medical facilities,
p.001181: trauma centers, and other entities in a region to develop an approach to emer- gency medical and trauma system
p.001181: access throughout the re- gion, including 9–1–1 Public Safety Answering Points and emergency medical
p.001181: dispatch;
p.001181: (2) includes a mechanism, such as a regional medical di- rection or transport communications system,
p.001181: that operates throughout the region to ensure that the patient is taken to the medically appropriate
p.001181: facility (whether an initial facility or a higher-level facility) in a timely fashion;
p.001181: (3) allows for the tracking of prehospital and hospital re- sources, including inpatient bed capacity,
p.001181: emergency depart- ment capacity, trauma center capacity, on-call specialist cov- erage, ambulance diversion
p.001181: status, and the coordination of such tracking with regional communications and hospital des- tination
p.001181: decisions; and
p.001181: (4) includes a consistent region-wide prehospital, hospital, and interfacility data management system that—
p.001181: (A) submits data to the National EMS Information System, the National Trauma Data Bank, and others;
p.001181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: Sec. 1204 PUBLIC HEALTH SERVICE ACT 1182
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p.001181: (B) reports data to appropriate Federal and State databanks and registries; and
p.001181: (C) contains information sufficient to evaluate key ele- ments of prehospital care, hospital destination
p.001181: decisions, including initial hospital and interfacility decisions, and relevant health outcomes of hospital care.
p.001181: (d) APPLICATION.—
p.001181: (1) IN GENERAL.—An eligible entity that seeks a contract or grant described in subsection (a) shall
p.001181: submit to the Sec- retary an application at such time and in such manner as the Secretary may require.
p.001181: (2) APPLICATION INFORMATION.—Each application shall in- clude—
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p.001183: 1183
p.001183: PUBLIC HEALTH SERVICE ACT
p.001183: Sec. 1212
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p.001183: cant extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.001183: contributions.
p.001183: (f) PRIORITY.—The Secretary shall give priority for the award of the contracts or grants described in
p.001183: subsection (a) to any eligible entity that serves a population in a medically underserved area (as defined in section
p.001183: 330(b)(3)).
p.001183: (g) REPORT.—Not later than 90 days after the completion of a pilot project under subsection (a), the
p.001183: recipient of such contract or grant described in shall submit to the Secretary a report containing the results of
p.001183: an evaluation of the program, including an identifica- tion of—
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p.001183: (1) the impact of the regional, accountable emergency care and trauma system on patient health outcomes for various
p.001183: crit- ical care categories, such as trauma, stroke, cardiac emer- gencies, neurological emergencies, and
p.001183: pediatric emergencies;
p.001183: (2) the system characteristics that contribute to the effec- tiveness and efficiency of the program (or lack
p.001183: thereof);
p.001183: (3) methods of assuring the long-term financial sustain- ability of the emergency care and trauma system;
p.001183: (4) the State and local legislation necessary to implement and to maintain the system;
p.001183: (5) the barriers to developing regionalized, accountable emergency care and trauma systems, as well as
p.001183: the methods to overcome such barriers; and
p.001183: (6) recommendations on the utilization of available funding for future regionalization efforts.
p.001183: (h) DISSEMINATION OF FINDINGS.—The Secretary shall, as ap- propriate, disseminate to the public and to
p.001183: the appropriate Com- mittees of the Congress, the information contained in a report made under subsection
p.001183: (g).
p.001183: PART B—FORMULA GRANTS WITH RESPECT TO MODIFICATIONS OF
p.001183: STATE PLANS
p.001183: SEC. 1211. ø300d–11¿ ESTABLISHMENT OF PROGRAM.
p.001183: (a) REQUIREMENT OF ALLOTMENTS FOR STATES.—The Secretary shall for each fiscal year make an allotment for
p.001183: each State in an amount determined in accordance with section 1218. The Secretary shall make payments, as grants,
p.001183: each fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.001183: year involved an application submitted by the State pursuant to section 1217.
p.001183: (b) PURPOSE.—Except as provided in section 1233, the Sec- retary may not make payments under this part for a
p.001183: fiscal year un- less the State involved agrees that, with respect to the trauma care component of the State plan for
p.001183: the provision of emergency medical services, the payments will be expended only for the purpose of de- veloping,
p.001183: implementing, and monitoring the modifications to such component described in section 1213.
p.001183: SEC. 1212. ø300d–12¿ REQUIREMENT OF MATCHING FUNDS FOR FISCAL YEARS SUBSEQUENT TO FIRST FISCAL YEAR OF
p.001183: PAY- MENTS.
p.001183: (a) NON-FEDERAL CONTRIBUTIONS.—
p.001183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001183: Sec. 1213 PUBLIC HEALTH SERVICE ACT 1184
p.001183: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) unless the State involved
p.001183: agrees, with respect to the costs described in paragraph (2), to make avail- able non-Federal contributions (in
p.001183: cash or in kind under sub- section (b)(1)) toward such costs in an amount that—
p.001183: (A) for the second and third fiscal years of such pay- ments to the State, is not less than $1 for each $1 of
p.001183: Fed- eral funds provided in such payments for such fiscal years; and
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p.001183: (B) for the fourth and subsequent fiscal years of such payments to the State, is not less than $2 for
p.001183: each $1 of Federal funds provided in such payments for such fiscal years.
p.001183: (2) PROGRAM COSTS.—The costs referred to in paragraph
p.001183: (1) are—
p.001183: (A) the costs to be incurred by the State in carrying out the purpose described in section 1211(b); or
p.001183: (B) the costs of improving the quality and availability of emergency medical services in rural areas of the
p.001183: State.
p.001183: (3) INITIAL YEAR OF PAYMENTS.—The Secretary may not re- quire a State to make non-Federal contributions as a condition
p.001183: of receiving payments under section 1211(a) for the first fiscal year of such payments to the State.
p.001183: (b) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBU- TION.—With respect to compliance with subsection
p.001183: (a) as a condi- tion of receiving payments under section 1211(a)—
p.001183: (1) a State may make the non-Federal contributions re- quired in such subsection in cash or in kind,
p.001183: fairly evaluated, including plant, equipment, or services; and
p.001183: (2) the Secretary may not, in making a determination of the amount of non-Federal contributions, include
p.001183: amounts pro- vided by the Federal Government or services assisted or sub- sidized to any significant extent by
p.001183: the Federal Government.
p.001183: SEC. 1213. ø300d–13¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF ALLOTMENTS.
p.001183: (a) TRAUMA CARE MODIFICATIONS TO STATE PLAN FOR EMER- GENCY MEDICAL SERVICES.—With respect to the trauma
p.001183: care com- ponent of a State plan for the provision of emergency medical serv- ices, the modifications referred to in
p.001183: section 1211(b) are such modi- fications to the State plan as may be necessary for the State in- volved to
p.001183: ensure that the plan provides for access to the highest possible quality of trauma care, and that the plan—
p.001183: (1) specifies that the modifications required pursuant to paragraphs (2) through (11) will be implemented
p.001183: by the prin- cipal State agency with respect to emergency medical services or by the designee of such agency;
p.001183: (2) specifies a public or private entity that will designate trauma care regions and trauma centers in the
p.001183: State;
p.001183: (3) subject to subsection (b), contains national standards and requirements of the American College of
p.001183: Surgeons or an- other appropriate entity for the designation of level I and level II trauma centers, and in the case
p.001183: of rural areas level III trau- ma centers (including trauma centers with specified capabili-
p.001183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001185: 1185
p.001185: PUBLIC HEALTH SERVICE ACT
p.001185: Sec. 1213
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p.001185: ties and expertise in the care of pediatric trauma patients), by such entity, including standards and requirements for—
p.001185: (A) the number and types of trauma patients for whom such centers must provide care in order to ensure that
p.001185: such centers will have sufficient experience and expertise to be able to provide quality care for victims of
p.001185: injury;
p.001185: (B) the resources and equipment needed by such cen- ters; and
p.001185: (C) the availability of rehabilitation services for trau- ma patients;
p.001185: (4) contains standards and requirements for the implemen- tation of regional trauma care systems, including
p.001185: standards and guidelines (consistent with the provisions of section 1867 of the Social Security Act) for
p.001185: medically directed triage and transportation of trauma patients (including patients injured in rural areas)
p.001185: prior to care in designated trauma centers;
p.001185: (5) subject to subsection (b), contains national standards and requirements, including those of the American
p.001185: Academy of Pediatrics and the American College of Emergency Physicians, for medically directed triage and
p.001185: transport of severely injured children to designated trauma centers with specified capabili- ties and
p.001185: expertise in the care of pediatric trauma patients;
p.001185: (6) utilizes a program with procedures for the evaluation of designated trauma centers (including trauma
p.001185: centers de- scribed in paragraph (5)) and trauma care systems;
p.001185: (7) provides for the establishment and collection of data in accordance with data collection requirements developed in
p.001185: con- sultation with surgical, medical, and nursing specialty groups, State and local emergency medical services
p.001185: directors, and other trained professionals in trauma care, from each designated trauma center in the State
p.001185: of a central data reporting and analysis system—
p.001185: (A) to identify the number of severely injured trauma patients and the number of deaths from trauma
p.001185: within trauma care systems in the State;
p.001185: (B) to identify the cause of the injury and any factors contributing to the injury;
p.001185: (C) to identify the nature and severity of the injury;
p.001185: (D) to monitor trauma patient care (including prehospital care) in each designated trauma center
p.001185: within regional trauma care systems in the State (including rel- evant emergency-department discharges and
p.001185: rehabilitation information) for the purpose of evaluating the diagnosis, treatment, and treatment outcome of
p.001185: such trauma pa- tients;
p.001185: (E) to identify the total amount of uncompensated trauma care expenditures for each fiscal year by each des-
p.001185: ignated trauma center in the State; and
p.001185: (F) to identify patients transferred within a regional trauma system, including reasons for such transfer
p.001185: and the outcomes of such patients;
p.001185: (8) provides for the use of procedures by paramedics and emergency medical technicians to assess the severity
p.001185: of the in- juries incurred by trauma patients;
p.001185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001185: Sec. 1213 PUBLIC HEALTH SERVICE ACT 1186
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p.001185: (9) provides for appropriate transportation and transfer policies to ensure the delivery of patients to
p.001185: designated trauma centers and other facilities within and outside of the jurisdic- tion of such system,
p.001185: including policies to ensure that only indi- viduals appropriately identified as trauma patients are trans-
p.001185: ferred to designated trauma centers, and to provide periodic re- views of the transfers and the auditing of
p.001185: such transfers that are determined to be appropriate;
p.001185: (10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
p.001185: (11) coordinates planning for trauma systems with State disaster emergency planning and bioterrorism
p.001185: hospital pre- paredness planning; and
p.001185: (12) with respect to the requirements established in this subsection, provides for coordination and
p.001185: cooperation between the State and any other State with which the State shares any standard metropolitan statistical
p.001185: area.
p.001185: (b) CERTAIN STANDARDS WITH RESPECT TO TRAUMA CARE CEN-
p.001185: TERS AND SYSTEMS.—
p.001185: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) for a fiscal year unless the
p.001185: State in- volved agrees that, in carrying out paragraphs (3) through (5) of subsection (a), the State
p.001185: will adopt standards for the des- ignation of trauma centers, and for triage, transfer, and trans- portation
p.001185: policies, and that the State will, in adopting such standards—
p.001185: (A) take into account national standards that outline resources for optimal care of injured patients;
p.001185: (B) consult with medical, surgical, and nursing spe- ciality groups, hospital associations, emergency
p.001185: medical services State and local directors, concerned advocates, and other interested parties;
p.001185: (C) conduct hearings on the proposed standards after providing adequate notice to the public concerning
p.001185: such hearing; and
p.001185: (D) beginning in fiscal year 2008, take into account the model plan described in subsection (c).
p.001185: (2) QUALITY OF TRAUMA CARE.—The highest quality of trauma care shall be the primary goal of State
p.001185: standards adopted under this subsection.
p.001185: (3) APPROVAL BY THE SECRETARY.—The Secretary may not make payments under section 1211(a) to a State if
p.001185: the Sec- retary determines that—
p.001185: (A) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not taken
p.001185: into ac- count national standards, including those of the American College of Surgeons, the American College of
p.001185: Emergency Physicians, and the American Academy of Pediatrics, in adopting standards under this subsection; or
p.001185: (B) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not, in
p.001185: adopting such standards, taken into account the model plan devel- oped under subsection (c).
p.001185: (c) MODEL TRAUMA CARE PLAN.—
p.001185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001187: 1187
p.001187: PUBLIC HEALTH SERVICE ACT
p.001187: Sec. 1214
p.001187:
p.001187: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of the Trauma Care Systems Planning and
p.001187: De- velopment Act of 2007, the Secretary shall update the model plan for the designation of trauma
p.001187: centers and for triage, transfer, and transportation policies that may be adopted for guidance by the State.
p.001187: Such plan shall—
p.001187: (A) take into account national standards, including those of the American College of Surgeons, American
p.001187: Col- lege of Emergency Physicians, and the American Academy of Pediatrics;
p.001187: (B) take into account existing State plans;
p.001187: (C) be developed in consultation with medical, sur- gical, and nursing speciality groups, hospital
p.001187: associations, emergency medical services State directors and associa- tions, and other interested parties; and
p.001187: (D) include standards for the designation of rural health facilities and hospitals best able to
p.001187: receive, sta- bilize, and transfer trauma patients to the nearest appro- priate designated trauma center,
p.001187: and for triage, transfer, and transportation policies as they relate to rural areas.
p.001187: (2) APPLICABILITY.—Standards described in paragraph (1)(D) shall be applicable to all rural areas in the State,
p.001187: includ- ing both non-metropolitan areas and frontier areas that have populations of less than 6,000 per square
p.001187: mile.
p.001187: (d) RULE OF CONSTRUCTION WITH RESPECT TO NUMBER OF DESIGNATED TRAUMA CENTERS.—With respect to
p.001187: compliance with subsection (a) as a condition of the receipt of a grant under section 1211(a), such subsection may not
p.001187: be construed to specify the num- ber of trauma care centers designated pursuant to such subsection.
p.001187: SEC. 1214. ø300d–14¿ REQUIREMENT OF SUBMISSION TO SECRETARY OF TRAUMA PLAN AND CERTAIN INFORMATION.
p.001187: (a) IN GENERAL.—For each fiscal year, the Secretary may not make payments to a State under section 1211(a)
p.001187: unless, subject to subsection (b), the State submits to the Secretary the trauma care component of the State plan for
p.001187: the provision of emergency medical services, including any changes to the trauma care component and any plans to
p.001187: address deficiencies in the trauma care component.
p.001187: (b) INTERIM PLAN OR DESCRIPTION OF EFFORTS.—For each fis- cal year, if a State has not completed the
p.001187: trauma care component of the State plan described in subsection (a), the State may provide, in lieu of such completed
p.001187: component, an interim component or a de- scription of efforts made toward the completion of the component.
p.001187: (c) INFORMATION RECEIVED BY STATE REPORTING AND ANALYSIS SYSTEM.—The Secretary may not make payments to a State
p.001187: under section 1211(a) unless the State agrees that the State will, not less than once each year, provide to the
p.001187: Secretary the information re- ceived by the State pursuant to section 1213(a)(7).
p.001187: (d) AVAILABILITY OF EMERGENCY MEDICAL SERVICES IN RURAL AREAS.—The Secretary may not make payments to a
p.001187: State under section 1211(a) unless—
p.001187: (1) the State identifies any rural area in the State for which—
p.001187:
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p.001187: (A) there is no system of access to emergency medical services through the telephone number 911;
p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001187:
p.001187: (B) there is no basic life-support system; or
p.001187: (C) there is no advanced life-support system; and
p.001187: (2) the State submits to the Secretary a list of rural areas identified pursuant to paragraph (1) or, if there
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p.001191: the purpose of aiding the State in carrying out section 1211(b) and, for such purpose, may detail to the State
p.001191: any officer or employee of the Department of Health and Human Services.
p.001191: (2) REDUCTION IN PAYMENTS.—With respect to a request described in paragraph (1), the Secretary shall
p.001191: reduce the amount of payments to the State under section 1211(a) by an amount equal to the costs of
p.001191: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001191: Secretary. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001191: expend the amounts withheld.
p.001191: SEC. 1222. ø300d–22¿ REPORT BY SECRETARY.
p.001191: Not later than October 1, 2008, the Secretary shall report to the appropriate committees of Congress on
p.001191: the activities of the States carried out pursuant to section 1211. Such report shall in- clude an
p.001191: assessment of the extent to which Federal and State ef- forts to develop systems of trauma care and to
p.001191: designate trauma centers have reduced the incidence of mortality, and the incidence of permanent
p.001191: disability, resulting from trauma. Such report may include any recommendations of the Secretary for
p.001191: appropriate ad- ministrative and legislative initiatives with respect to trauma care.
p.001191: PART C—GENERAL PROVISIONS REGARDING PARTS A AND B
p.001191: SEC. 1231. ø300d–31¿ DEFINITIONS.
p.001191: For purposes of this part and parts A and B:
p.001191: (1) DESIGNATED TRAUMA CENTER.—The term ‘‘designated trauma center’’ means a trauma center designated in
p.001191: accord- ance with the modifications to the State plan described in sec- tion 1213.
p.001191: (2) STATE PLAN REGARDING EMERGENCY MEDICAL SERV- ICES.—The term ‘‘State plan’’, with respect to the
p.001191: provision of emergency medical services, means a plan for a comprehensive, organized system to provide for the
p.001191: access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and
p.001191: rehabilitation of patients of all ages with respect to emergency medical services.
p.001191: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.001191: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001191: (4) TRAUMA.—The term ‘‘trauma’’ means an injury result- ing from exposure to—
p.001191: (A) a mechanical force; or
p.001191: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001191: radioactive.
p.001191: (5) TRAUMA CARE COMPONENT OF STATE PLAN.—The term ‘‘trauma care component’’, with respect to components
p.001191: of the State plan for the provision of emergency medical services, means a plan for a comprehensive
p.001191: health care system, within rural and urban areas of the State, for the prompt recognition, prehospital care,
p.001191: emergency medical care, acute surgical and medical care, rehabilitation, and outcome evaluation of seri-
p.001191: ously injured patients.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001191:
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p.001191: Sec. 1232 PUBLIC HEALTH SERVICE ACT 1192
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p.001191: January 30, 2020
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p.001191: SEC. 1232. ø300d–32¿ FUNDING.
p.001191: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out parts A and B, subject to subsections (b)
p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
p.001191: appropriated is greater than
p.001191: $1,000,000, 50 percent of such appropriation shall be made avail- able for the purpose of carrying out part A
p.001191: and 50 percent shall be made available for the purpose of carrying out part B.
p.001191: (c) ALLOCATION OF PART A FUNDS.—Of the amounts appro- priated under subsection (a) for a fiscal year to carry
p.001191: out part A—
p.001191: (1) 10 percent of such amounts for such year shall be allo- cated for administrative purposes; and
p.001191: (2) 10 percent of such amounts for such year shall be allo- cated for the purpose of carrying out section 1202.
p.001191: (d) AUTHORITY.—For the purpose of carrying out parts A through C, beginning on the date of enactment of
p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
p.001191: (3) to provide emergency relief to ensure the continued and future availability of trauma services.
p.001191: (b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS.—
p.001191: (1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—Except as
p.001191: pro- vided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a)
p.001191: unless the trauma cen- ter is a participant in a trauma system that substantially com- plies with section 1213.
p.001191: (2) EXEMPTION.—Paragraph (1) shall not apply to trauma centers that are located in States with no existing
p.001191: trauma care system.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001193: PUBLIC HEALTH SERVICE ACT
p.001193: Sec. 1242
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p.001193: (3) QUALIFICATION FOR SUBSTANTIAL UNCOMPENSATED CARE COSTS.—The Secretary shall award substantial uncompensated
p.001193: care grants under subsection (a)(1) only to trauma centers meeting at least 1 of the criteria in 1 of
p.001193: the following 3 cat- egories:
p.001193: (A) CATEGORY A.—The criteria for category A are as follows:
p.001193: (i) At least 40 percent of the visits in the emer- gency department of the hospital in which the trauma
p.001193: center is located were charity or self-pay patients.
p.001193: (ii) At least 50 percent of the visits in such emer- gency department were Medicaid (under title XIX of the
p.001193: Social Security Act (42 U.S.C. 1396 et seq.)) and charity and self-pay patients combined.
p.001193: (B) CATEGORY B.—The criteria for category B are as follows:
p.001193: (i) At least 35 percent of the visits in the emer- gency department were charity or self-pay patients.
p.001193: (ii) At least 50 percent of the visits in the emer- gency department were Medicaid and charity and self- pay
p.001193: patients combined.
p.001193: (C) CATEGORY C.—The criteria for category C are as follows:
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p.001193: (i) At least 20 percent of the visits in the emer-
p.001193: gency department were charity or self-pay patients.
p.001193: (ii) At least 30 percent of the visits in the emer- gency department were Medicaid and charity and self- pay
p.001193: patients combined.
p.001193: (4) TRAUMA CENTERS IN 1115 WAIVER STATES.—Notwith- standing paragraph (3), the Secretary may award a
p.001193: substantial uncompensated care grant to a trauma center under subsection (a)(1) if the trauma center qualifies for
p.001193: funds under a Low In- come Pool or Safety Net Care Pool established through a waiv- er approved under section 1115
p.001193: of the Social Security Act (42
p.001193: U.S.C. 1315).
p.001193: (5) DESIGNATION.—The Secretary may not award a grant to a trauma center unless such trauma center is verified
p.001193: by the American College of Surgeons or designated by an equivalent State or local agency.
p.001193: (c) ADDITIONAL REQUIREMENTS.—The Secretary may not award a grant to a trauma center under subsection
p.001193: (a)(1) unless such trauma center—
p.001193: (1) submits to the Secretary a plan satisfactory to the Sec- retary that demonstrates a continued commitment to
p.001193: serving trauma patients regardless of their ability to pay; and
p.001193: (2) has policies in place to assist patients who cannot pay for part or all of the care they receive,
p.001193: including a sliding fee scale, and to ensure fair billing and collection practices.
p.001193: SEC. 1242. ø300d–42¿ PREFERENCES IN MAKING GRANTS.
p.001193: (a) SUBSTANTIAL UNCOMPENSATED CARE AWARDS.—
p.001193: (1) IN GENERAL.—The Secretary shall establish an award basis for each eligible trauma center for grants
p.001193: under section
p.001193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001193: Sec. 1243 PUBLIC HEALTH SERVICE ACT 1194
p.001193: 1241(a)(1) according to the percentage described in paragraph (2), subject to the requirements of section
p.001193: 1241(b)(3).
p.001193: (2) PERCENTAGES.—The applicable percentages are as fol- lows:
p.001193: (A) With respect to a category A trauma center, 100 percent of the uncompensated care costs.
p.001193: (B) With respect to a category B trauma center, not more than 75 percent of the uncompensated care costs.
p.001193: (C) With respect to a category C trauma center, not more than 50 percent of the uncompensated care costs.
p.001193: (b) 1 CORE MISSION AWARDS.—
p.001193: (1) IN GENERAL.—In awarding grants under section 1241(a)(2), the Secretary shall—
p.001193: (A) reserve 25 percent of the amount allocated for core mission awards for Level III and Level IV trauma centers; and
p.001193: (B) reserve 25 percent of the amount allocated for core mission awards for large urban Level I and II trauma cen- ters—
p.001193: (i) that have at least 1 graduate medical education fellowship in trauma or trauma related specialties for which
p.001193: demand is exceeding supply;
p.001193: (ii) for which—
p.001193: (I) annual uncompensated care costs exceed
p.001193: $10,000,000; or
p.001193: (II) at least 20 percent of emergency depart- ment visits are charity or self-pay or Medicaid pa- tients; and
p.001193: (iii) that are not eligible for substantial uncompen- sated care awards under section 1241(a)(1).
p.001193: (c) EMERGENCY AWARDS.—In awarding grants under section 1241(a)(3), the Secretary shall—
p.001193: (1) give preference to any application submitted by a trau- ma center that provides trauma care in a geographic
p.001193: area in which the availability of trauma care has significantly de- creased or will significantly
p.001193: decrease if the center is forced to close or downgrade service or growth in demand for trauma services
p.001193: exceeds capacity; and
p.001193: (2) reallocate any emergency awards funds not obligated due to insufficient, or a lack of qualified,
p.001193: applications to the significant uncompensated care award program.
p.001193: SEC. 1243. ø300d–43¿ CERTAIN AGREEMENTS.
p.001193: (a) MAINTENANCE OF FINANCIAL SUPPORT.—The Secretary may require a trauma center receiving a grant under section
p.001193: 1241(a) to maintain access to trauma services at comparable levels to the prior year during the grant period.
p.001193: (b) TRAUMA CARE REGISTRY.—The Secretary may require the trauma center receiving a grant under section
p.001193: 1241(a) to provide data to a national and centralized registry of trauma cases, in ac- cordance with
p.001193: guidelines developed by the American College of Sur- geons, and as the Secretary may otherwise require.
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p.001193: 1 So in law. Subsection (b) includes a paragraph (1) but does not include subsequent
p.001193: paragaraphs.
p.001193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001195: PUBLIC HEALTH SERVICE ACT
p.001195: Sec. 1245
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p.001195: January 30, 2020
p.001195: SEC. 1244. ø300d–44¿ GENERAL PROVISIONS.
p.001195: (a) APPLICATION.—The Secretary may not award a grant to a trauma center under section 1241(a) unless such
p.001195: center submits an application for the grant to the Secretary and the application is in such form, is made in such
p.001195: manner, and contains such agreements, assurances, and information as the Secretary determines to be nec- essary to
p.001195: carry out this part.
p.001195: (b) LIMITATION ON DURATION OF SUPPORT.—The period during which a trauma center receives payments under a grant
p.001195: under sec- tion 1241(a)(3) shall be for 3 fiscal years, except that the Secretary may waive such requirement for a
p.001195: center and authorize such center to receive such payments for 1 additional fiscal year.
p.001195: (c) LIMITATION ON AMOUNT OF GRANT.—Notwithstanding sec- tion 1242(a), a grant under section 1241 may
p.001195: not be made in an amount exceeding $2,000,000 for each fiscal year.
p.001195: (d) ELIGIBILITY.—Except as provided in section 1242(b)(1)(B)(iii), acquisition of, or
p.001195: eligibility for, a grant under sec- tion 1241(a) shall not preclude a trauma center from being eligible for other
p.001195: grants described in such section.
p.001195: (e) FUNDING DISTRIBUTION.—Of the total amount appropriated for a fiscal year under section 1245, 70 percent
p.001195: shall be used for substantial uncompensated care awards under section 1241(a)(1),
p.001195: 20 percent shall be used for core mission awards under section 1241(a)(2), and 10 percent shall be used
p.001195: for emergency awards under section 1241(a)(3).
p.001195: (f) MINIMUM ALLOWANCE.—Notwithstanding subsection (e), if the amount appropriated for a fiscal year under
p.001195: section 1245 is less than $25,000,000, all available funding for such fiscal year shall be used for substantial
p.001195: uncompensated care awards under section 1241(a)(1).
p.001195: (g) SUBSTANTIAL UNCOMPENSATED CARE AWARD DISTRIBUTION AND PROPORTIONAL SHARE.—Notwithstanding section
p.001195: 1242(a), of the amount appropriated for substantial uncompensated care grants for a fiscal year, the
p.001195: Secretary shall—
p.001195: (1) make available—
p.001195: (A) 50 percent of such funds for category A trauma center grantees;
p.001195: (B) 35 percent of such funds for category B trauma center grantees; and
p.001195: (C) 15 percent of such funds for category C trauma center grantees; and
p.001195: (2) provide available funds within each category in a man- ner proportional to the award basis specified
p.001195: in section 1242(a)(2) to each eligible trauma center.
p.001195: (h) REPORT.—Beginning 2 years after the date of enactment of the Patient Protection and Affordable Care Act, and every
p.001195: 2 years thereafter, the Secretary shall biennially report to Congress regard- ing the status of the grants made
p.001195: under section 1241 and on the overall financial stability of trauma centers.
p.001195: SEC. 1245. ø300d–45¿ AUTHORIZATION OF APPROPRIATIONS.
p.001195: For the purpose of carrying out this part, there are authorized to be appropriated $100,000,000 for fiscal year
p.001195: 2009, and such sums as may be necessary for each of fiscal years 2010 through 2015. Such authorization
p.001195: of appropriations is in addition to any
p.001195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001195: Sec. 1246 PUBLIC HEALTH SERVICE ACT 1196
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p.001195: other authorization of appropriations or amounts that are available for such purpose.
p.001195: SEC. 1246. ø300d–46¿ DEFINITION.
p.001195: In this part, the term ‘‘uncompensated care costs’’ means unre- imbursed costs from serving self-pay, charity, or
p.001195: Medicaid patients, without regard to payment under section 1923 of the Social Secu- rity Act, all of which
p.001195: are attributable to emergency care and trau- ma care, including costs related to subsequent inpatient admissions to the
p.001195: hospital.
p.001195: Part E—Miscellaneous Programs
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p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
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p.001199: January 30, 2020
p.001199: with other Federal agencies that carry out activities regarding traumatic brain injury.
p.001199: (g) REPORT.—Not less than biennially, the Secretary shall sub- mit to the Committee on Energy and Commerce of
p.001199: the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions of the
p.001199: Senate, a report describing the findings and results of the programs established under this section and sec- tion
p.001199: 1253, including measures of outcomes and consumer and sur- rogate satisfaction.
p.001199: (h) DEFINITIONS.—For purposes of this section:
p.001199: (1) The terms ‘‘American Indian consortium’’ and ‘‘State’’ have the meanings given to those terms in section
p.001199: 1253.
p.001199: (2) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001199: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001199: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001199: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001199: private entities.
p.001199: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001199: to be appropriated
p.001199: $7,321,000 for each of fiscal years 2020 through 2024.
p.001199: SEC. 1253. ø300d–53¿ STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.
p.001199: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001199: Living, shall make grants to protection and advocacy systems for the purpose of ena- bling such systems
p.001199: to provide services to individuals with trau- matic brain injury.
p.001199: (b) SERVICES PROVIDED.—Services provided under this section may include the provision of—
p.001199: (1) information, referrals, and advice;
p.001199: (2) individual and family advocacy;
p.001199: (3) legal representation; and
p.001199: (4) specific assistance in self-advocacy.
p.001199: (c) APPLICATION.—To be eligible to receive a grant under this section, a protection and advocacy system shall
p.001199: submit an applica- tion to the Secretary at such time, in such form and manner, and accompanied by such
p.001199: information and assurances as the Secretary may require.
p.001199: (d) APPROPRIATIONS LESS THAN $2,700,000.—
p.001199: (1) IN GENERAL.—With respect to any fiscal year in which the amount appropriated under subsection (l) to carry
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p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001203: PUBLIC HEALTH SERVICE ACT
p.001203: Sec. 1261
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p.001203: (4) health care and social service provider profiles.
p.001203: (e) DATA COLLECTION AND REPORTING.—
p.001203: (1) IN GENERAL.—The Secretary shall collect data and re- port on the following:
p.001203: (A) The total number of entities that received a grant under this section.
p.001203: (B) The total number and geographic distribution of health care and social service providers trained
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p.001203: report to be submitted under paragraph (3), the Secretary shall col- lect data on the total number of
p.001203: facilities and health care pro- fessional organizations that were operating under, and the total number of
p.001203: health care and social service providers trained through, the Stop, Observe, Ask, and Respond to Health and
p.001203: Wellness Training Program existing prior to the establishment of the Program under this section.
p.001203: (3) ANNUAL REPORT.—Not later than 1 year after the date of enactment of this section, and annually
p.001203: thereafter, the Sec- retary shall submit an annual report to Congress on the data collected under this
p.001203: subsection in a manner that, at a min- imum, prevents the disclosure of individually identifiable infor- mation
p.001203: consistent with all applicable privacy laws and regula- tions.
p.001203: (f) SHARING BEST PRACTICES.—The Secretary shall make avail- able, on the Internet website of the Department of
p.001203: Health and Human Services, a description of the best practices and procedures used by entities that receive a
p.001203: grant for carrying out activities under this section.
p.001203: (g) DEFINITION.—In this section, the term ‘‘human trafficking’’ has the meaning given the term ‘‘severe forms of
p.001203: trafficking in per- sons’’ as defined in section 103 of the Trafficking Victims Protection Act of 2000.
p.001203: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this Act, $4,000,000
p.001203: for each of fis- cal years 2020 through 2024.
p.001203: PART F—INTERAGENCY PROGRAM FOR TRAUMA RESEARCH
p.001203: SEC. 1261. ø300d–61¿ ESTABLISHMENT OF PROGRAM.
p.001203: (a) IN GENERAL.—The Secretary, acting through the Director of the National Institutes of Health (in this section
p.001203: referred to as the ‘‘Director’’), shall establish a comprehensive program of conducting basic and clinical research on
p.001203: trauma (in this section referred to as the ‘‘Program’’). The Program shall include research regarding the
p.001203: diagnosis, treatment, rehabilitation, and general management of trauma.
p.001203: (b) PLAN FOR PROGRAM.—
p.001203: (1) IN GENERAL.—The Director, in consultation with the Trauma Research Interagency Coordinating Committee
p.001203: estab- lished under subsection (g), shall establish and implement a plan for carrying out the activities
p.001203: of the Program, including the activities described in subsection (d). All such activities
p.001203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001203:
p.001203: shall be carried out in accordance with the plan. The plan shall be periodically reviewed, and revised as appropriate.
p.001203: (2) SUBMISSION TO CONGRESS.—Not later than December 1, 1993, the Director shall submit the plan required in paragraph
p.001203: (1) to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on
p.001203: Health, Edu- cation, Labor, and Pensions of the Senate, together with an es- timate of the funds needed for each
p.001203: of the fiscal years 1994 through 1996 to implement the plan.
p.001203: (c) PARTICIPATING AGENCIES; COORDINATION AND COLLABORA-
p.001203: TION.—The Director—
p.001203: (1) shall provide for the conduct of activities under the Program by the Directors of the agencies of the
p.001203: National Insti- tutes of Health involved in research with respect to trauma;
p.001203: (2) shall ensure that the activities of the Program are co- ordinated among such agencies; and
p.001203: (3) shall, as appropriate, provide for collaboration among such agencies in carrying out such activities.
p.001203: (d) CERTAIN ACTIVITIES OF PROGRAM.—The Program shall in- clude—
p.001203: (1) studies with respect to all phases of trauma care, in- cluding prehospital, resuscitation, surgical
p.001203: intervention, critical care, infection control, wound healing, nutritional care and support, and medical
p.001203: rehabilitation care;
p.001203: (2) basic and clinical research regarding the response of the body to trauma and the acute treatment and
p.001203: medical reha- bilitation of individuals who are the victims of trauma;
p.001203: (3) basic and clinical research regarding trauma care for pediatric and geriatric patients; and
p.001203: (4) the authority to make awards of grants or contracts to public or nonprofit private entities for the conduct of
p.001203: basic and applied research regarding traumatic brain injury, which re- search may include—
p.001203: (A) the development of new methods and modalities for the more effective diagnosis, measurement of degree of
p.001203: brain injury, post-injury monitoring and prognostic assess- ment of head injury for acute, subacute and later
p.001203: phases of care;
p.001203: (B) the development, modification and evaluation of therapies that retard, prevent or reverse brain damage
p.001203: after acute head injury 3, that arrest further deterioration following injury and that provide the
p.001203: restitution of func- tion for individuals with long-term injuries;
p.001203: (C) the development of research on a continuum of care from acute care through rehabilitation, designed,
p.001203: to the extent practicable, to integrate rehabilitation and long- term outcome evaluation with acute care research;
p.001203: (D) the development of programs that increase the participation of academic centers of excellence in brain in-
p.001203:
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p.001203:
p.001203:
p.001203:
p.001203: January 30, 2020
p.001203: 3 Section 1303(a)(2) of Public Law 106–310 (114 Stat. 1138) provides that subparagraph (B) is amended by
p.001203: striking ‘‘acute injury’’ and inserting ‘‘acute brain injury’’. The amendment cannot be executed because the term
p.001203: to be struck does not appear in subparagraph (B). (Compare ‘‘acute injury’’ and ‘‘acute head injury’’.)
p.001203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001205: 1205
p.001205: PUBLIC HEALTH SERVICE ACT
p.001205: Sec. 1261
p.001205:
p.001205: jury treatment and rehabilitation research and training; and
p.001205:
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p.001205: (E) carrying out subparagraphs (A) through (D) with respect to cognitive disorders and neurobehavioral
p.001205: con- sequences arising from traumatic brain injury, including the development, modification, and evaluation of
p.001205: therapies and programs of rehabilitation toward reaching or restor- ing normal capabilities in areas such
p.001205: as reading, com- prehension, speech, reasoning, and deduction.
p.001205: (e) MECHANISMS OF SUPPORT.—In carrying out the Program, the Director, acting through the Directors of
p.001205: the agencies referred to in subsection (c)(1), may make grants to public and nonprofit en- tities, including
p.001205: designated trauma centers.
p.001205: (f) RESOURCES.—The Director shall assure the availability of appropriate resources to carry out the Program,
p.001205: including the plan established under subsection (b) (including the activities described in subsection (d)).
p.001205: (g) COORDINATING COMMITTEE.—
p.001205: (1) IN GENERAL.—There shall be established a Trauma Re- search Interagency Coordinating Committee (in this section re-
p.001205: ferred to as the ‘‘Coordinating Committee’’).
p.001205: (2) DUTIES.—The Coordinating Committee shall make rec- ommendations regarding—
p.001205: (A) the activities of the Program to be carried out by each of the agencies represented on the Committee and
p.001205: the amount of funds needed by each of the agencies for such activities; and
p.001205: (B) effective collaboration among the agencies in car- rying out the activities.
p.001205: (3) COMPOSITION.—The Coordinating Committee shall be composed of the Directors of each of the agencies
p.001205: that, under subsection (c), have responsibilities under the Program, and any other individuals who are
p.001205: practitioners in the trauma field as designated by the Director of the National Institutes of Health.
p.001205: (h) DEFINITIONS.—For purposes of this section:
p.001205: (1) The term ‘‘designated trauma center’’ has the meaning given such term in section 1231(1).
p.001205: (2) The term ‘‘Director’’ means the Director of the National Institutes of Health.
p.001205: (3) The term ‘‘trauma’’ means an injury resulting from ex- posure to—
p.001205: (A) a mechanical force; or
p.001205: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001205: radioactive.
p.001205: (4) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001205: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001205: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001205: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001205: private entities.
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001205:
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p.001205: Sec. 1271 PUBLIC HEALTH SERVICE ACT 1206
p.001205:
p.001205: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001205: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005, and such
p.001205: sums as may be necessary for each of the fiscal years 2009 through 2012.
p.001205: PART G—POISON CONTROL
p.001205: SEC. 1271. ø300d–71¿ MAINTENANCE OF THE NATIONAL TOLL-FREE NUMBER AND OTHER COMMUNICATION CAPABILITIES.
p.001205: (a) IN GENERAL.—The Secretary—
p.001205: (1) shall provide coordination and assistance to poison con- trol centers for the establishment and maintenance of a
p.001205: nation- wide toll-free phone number, to be used to access such centers; and
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p.001209: and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives a
p.001209: report concerning the operations of, and trends identified by, the Poison Control Network. Such report shall
p.001209: include—
p.001209: (1) descriptions of the activities carried out pursuant to sections 1271, 1272, and 1273, and the
p.001209: alignment of such ac- tivities with the purposes provided under subsection (a);
p.001209: (2) a description of trends in volume of contacts to poison control centers;
p.001209: (3) a description of trends in poisonings and toxic expo- sures reported to poison control centers, as
p.001209: applicable and ap- propriate;
p.001209: (4) an assessment of the impact of the public awareness campaign, including any geographic variations;
p.001209: (5) a description of barriers, if any, preventing poison con- trol centers from achieving the purposes and
p.001209: programs under this section and sections 1271 and 1272;
p.001209: (6) a description of the standards for accreditation de- scribed in subsection (c), including any
p.001209: variations in those standards, and any efforts to create and maintain consistent standards across
p.001209: organizations that accredit poison control cen- ters; and
p.001209: (7) the number of and reason for any waivers provided under subsection (d).
p.001209: SEC. 1274. ø300d–74¿ RULE OF CONSTRUCTION.
p.001209: Nothing in this part may be construed to ease any restriction in Federal law applicable to the amount or
p.001209: percentage of funds ap- propriated to carry out this part that may be used to prepare or submit a report.
p.001209: PART H—TRAUMA SERVICE AVAILABILITY
p.001209:
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p.001209: January 30, 2020
p.001209: SEC. 1281. ø300d–81¿ GRANTS TO STATES.
p.001209: (a) ESTABLISHMENT.—To promote universal access to trauma care services provided by trauma centers and
p.001209: trauma-related physi- cian specialties, the Secretary shall provide funding to States to en- able such States to
p.001209: award grants to eligible entities for the pur- poses described in this section.
p.001209: (b) AWARDING OF GRANTS BY STATES.—Each State may award grants to eligible entities within the State for
p.001209: the purposes de- scribed in subparagraph (d).
p.001209: (c) ELIGIBILITY.—
p.001209: (1) IN GENERAL.—To be eligible to receive a grant under subsection (b) an entity shall—
p.001209: (A) be—
p.001209: (i) a public or nonprofit trauma center or consor- tium thereof that meets that requirements of para-
p.001209: graphs (1), (2), and (5) of section 1241(b);
p.001209: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001209:
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p.001209: Sec. 1281 PUBLIC HEALTH SERVICE ACT 1210
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p.001209: (ii) a safety net public or nonprofit trauma center that meets the requirements of paragraphs (1) through
p.001209: (5) of section 1241(b); or
p.001209: (iii) a hospital in an underserved area (as defined by the State) that seeks to establish new trauma serv- ices; and
p.001209: (B) submit to the State an application at such time, in such manner, and containing such information as
p.001209: the State may require.
p.001209: (2) LIMITATION.—A State shall use at least 40 percent of the amount available to the State under this
p.001209: part for a fiscal year to award grants to safety net trauma centers described in paragraph (1)(A)(ii).
p.001209: (d) USE OF FUNDS.—The recipient of a grant under subsection
p.001209: (b) shall carry out 1 or more of the following activities consistent with subsection (b):
p.001209: (1) Providing trauma centers with funding to support phy- sician compensation in trauma-related physician
p.001209: specialties where shortages exist in the region involved, with priority pro- vided to safety net trauma centers
p.001209: described in subsection (c)(1)(A)(ii).
p.001209: (2) Providing for individual safety net trauma center fiscal stability and costs related to having service that is
p.001209: available 24 hours a day, 7 days a week, with priority provided to safety net trauma centers described in
p.001209: subsection (c)(1)(A)(ii) located in urban, border, and rural areas.
p.001209: (3) Reducing trauma center overcrowding at specific trau- ma centers related to throughput of trauma patients.
p.001209: (4) Establishing new trauma services in underserved areas as defined by the State.
p.001209: (5) Enhancing collaboration between trauma centers and other hospitals and emergency medical services
p.001209: personnel re- lated to trauma service availability.
p.001209: (6) Making capital improvements to enhance access and expedite trauma care, including providing helipads and
p.001209: associ- ated safety infrastructure.
p.001209: (7) Enhancing trauma surge capacity at specific trauma centers.
p.001209: (8) Ensuring expedient receipt of trauma patients trans- ported by ground or air to the appropriate trauma
p.001209: center.
p.001209: (9) Enhancing interstate trauma center collaboration.
p.001209: (e) LIMITATION.—
p.001209: (1) IN GENERAL.—A State may use not more than 20 per- cent of the amount available to the State under
p.001209: this part for a fiscal year for administrative costs associated with awarding grants and related costs.
p.001209: (2) MAINTENANCE OF EFFORT.—The Secretary may not pro- vide funding to a State under this part unless the State agrees
p.001209: that such funds will be used to supplement and not supplant State funding otherwise available for the
p.001209: activities and costs described in this part.
p.001209: (f) DISTRIBUTION OF FUNDS.—The following shall apply with re- spect to grants provided in this part:
p.001209: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001211: 1211
p.001211: PUBLIC HEALTH SERVICE ACT
p.001211: Sec. 1291
p.001211:
p.001211: (1) LESS THAN $10,000,000.—If the amount of appropriations for this part in a fiscal year is less than $10,000,000,
p.001211: the Sec- retary shall divide such funding evenly among only those States that have 1 or more trauma
p.001211: centers eligible for funding under section 1241(b)(3)(A).
p.001211: (2) LESS THAN $20,000,000.—If the amount of appropriations in a fiscal year is less than $20,000,000, the Secretary
p.001211: shall di- vide such funding evenly among only those States that have 1 or more trauma centers eligible for
p.001211: funding under subpara- graphs (A) and (B) of section 1241(b)(3).
p.001211: (3) LESS THAN $30,000,000.—If the amount of appropriations for this part in a fiscal year is less than $30,000,000,
p.001211: the Sec- retary shall divide such funding evenly among only those States that have 1 or more trauma
p.001211: centers eligible for funding under section 1241(b)(3).
p.001211: (4) $30,000,000 OR MORE.—If the amount of appropriations for this part in a fiscal year is $30,000,000 or
p.001211: more, the Sec- retary shall divide such funding evenly among all States.
p.001211: SEC. 1282. ø300d–82¿ AUTHORIZATION OF APPROPRIATIONS.
p.001211: For the purpose of carrying out this part, there is authorized to be appropriated $100,000,000 for
p.001211: each of fiscal years 2010 through 2015.
p.001211:
p.001211: PART I—MILITARY AND CIVILIAN PARTNER- SHIP FOR TRAUMA READINESS GRANT PRO- GRAM
p.001211:
p.001211: SEC. 1291. ø300d–91¿ MILITARY AND CIVILIAN PARTNERSHIP FOR TRAUMA READINESS GRANT PROGRAM.
p.001211: (a) MILITARY TRAUMA TEAM PLACEMENT PROGRAM.—
p.001211: (1) IN GENERAL.—The Secretary, acting through the Assist- ant Secretary for Preparedness and Response and in consulta-
p.001211: tion with the Secretary of Defense, shall award grants to not more than 20 eligible high-acuity trauma
p.001211: centers to enable military trauma teams to provide, on a full-time basis, trauma care and related acute care at such
p.001211: trauma centers.
p.001211: (2) LIMITATIONS.—In the case of a grant awarded under paragraph (1) to an eligible high-acuity trauma
p.001211: center, such grant—
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p.001211: (A) shall be for a period of at least 3 years and not more than 5 years (and may be renewed at the end of
p.001211: such period); and
p.001211: (B) shall be in an amount that does not exceed
p.001211: $1,000,000 per year.
p.001211: (3) AVAILABILITY OF FUNDS.—Notwithstanding section 1552 of title 31, United States Code, or any other
p.001211: provision of law, funds available to the Secretary for obligation for a grant under this subsection shall
p.001211: remain available for expenditure for 100 days after the last day of the performance period of such
p.001211: grant.
p.001211: (b) MILITARY TRAUMA CARE PROVIDER PLACEMENT PROGRAM.—
p.001211: (1) IN GENERAL.—The Secretary, acting through the Assist- ant Secretary for Preparedness and Response and in consulta-
p.001211: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001211: tion with the Secretary of Defense, shall award grants to eligi- ble trauma centers to enable military trauma care
p.001211: providers to provide trauma care and related acute care at such trauma centers.
p.001211: (2) LIMITATIONS.—In the case of a grant awarded under paragraph (1) to an eligible trauma center, such grant—
p.001211: (A) shall be for a period of at least 1 year and not more than 3 years (and may be renewed at the end of
p.001211: such period); and
p.001211: (B) shall be in an amount that does not exceed, in a year—
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p.001211: (i) $100,000 for each military trauma care pro- vider that is a physician at such eligible trauma cen-
p.001211: ter; and
p.001211: (ii) $50,000 for each other military trauma care provider at such eligible trauma center.
p.001211: (c) GRANT REQUIREMENTS.—
p.001211: (1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As a condition of receipt of a grant under this section, a
p.001211: grant re- cipient shall agree to allow military trauma care providers pro- viding care pursuant to such grant to—
p.001211: (A) be deployed by the Secretary of Defense for mili- tary operations, for training, or for response to a mass
p.001211: cas- ualty incident; and
p.001211: (B) be deployed by the Secretary of Defense, in con- sultation with the Secretary of Health and Human
p.001211: Serv- ices, for response to a public health emergency pursuant to section 319.
p.001211: (2) USE OF FUNDS.—Grants awarded under this section to an eligible trauma center may be used to train and
p.001211: incorporate military trauma care providers into such trauma center, in- cluding incorporation into
p.001211: operational exercises and training drills related to public health emergencies, expenditures for malpractice
p.001211: insurance, office space, information technology, specialty education and supervision, trauma
p.001211: programs, re- search, and applicable license fees for such military trauma care providers.
p.001211: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect any other provision of
p.001211: law that preempts State licensing requirements for health care professionals, including with respect to military
p.001211: trauma care providers.
p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
p.001211: and the Secretary of De- fense a report for such year that includes information on—
p.001211: (A) the number and types of trauma cases managed by military trauma teams or military trauma care providers
p.001211: pursuant to such grant during such year;
p.001211: (B) the ability to maintain the integration of the mili- tary trauma providers or teams of providers as part of the
p.001211: trauma center, including the financial effect of such grant on the trauma center;
p.001211: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001211:
p.001211:
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p.001211:
p.001213: 1213
p.001213: PUBLIC HEALTH SERVICE ACT
p.001213: Sec. 1291
p.001213:
p.001213: (C) the educational effect on resident trainees in cen- ters where military trauma teams are assigned;
p.001213: (D) any research conducted during such year sup- ported by such grant; and
p.001213: (E) any other information required by the Secretaries for the purpose of evaluating the effect of such grant.
p.001213: (2) REPORT TO CONGRESS.—Not less than once every 2 years, the Secretary, in consultation with the Secretary of
p.001213: De- fense, shall submit a report to the congressional committees of jurisdiction that includes information on the
p.001213: effect of placing military trauma care providers in trauma centers awarded grants under this section on—
p.001213: (A) maintaining military trauma care providers’ readi- ness and ability to respond to and treat battlefield injuries;
p.001213: (B) providing health care to civilian trauma patients in urban and rural settings;
p.001213: (C) the capability of trauma centers and military trau- ma care providers to increase medical surge capacity,
p.001213: in- cluding as a result of a large-scale event;
p.001213: (D) the ability of grant recipients to maintain the inte- gration of the military trauma providers or teams of
p.001213: pro- viders as part of the trauma center;
p.001213: (E) efforts to incorporate military trauma care pro- viders into operational exercises and training and drills
p.001213: for public health emergencies; and
p.001213: (F) the capability of military trauma care providers to participate as part of a medical response during or in
p.001213: ad- vance of a public health emergency, as determined by the Secretary, or a mass casualty incident.
p.001213: (f) DEFINITIONS.—For purposes of this part:
p.001213: (1) ELIGIBLE HIGH-ACUITY TRAUMA CENTER.—The term ‘‘eli- gible high-acuity trauma center’’ means a Level I trauma
p.001213: cen- ter that satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams
p.001213: to provide trauma care and related acute care at such trauma center.
p.001213: (B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which
p.001213: data are available are treated for a major trauma at such trauma center.
p.001213: (C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (D) Such trauma center is an academic training cen- ter—
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213: January 30, 2020
p.001213: (i) affiliated with a medical school;
p.001213: (ii) that maintains residency programs and fellow- ships in critical trauma specialties and subspecialties, and
p.001213: provides education and supervision of military trauma team members according to those specialties and
p.001213: subspecialties; and
p.001213: (iii) that undertakes research in the prevention and treatment of traumatic injury.
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001213:
p.001213:
p.001213:
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p.001213:
p.001213: Sec. 1301 PUBLIC HEALTH SERVICE ACT 1214
p.001213:
p.001213: (E) Such trauma center serves as a medical and public health preparedness and response leader for its commu-
p.001213: nity, such as by participating in a partnership for State and regional hospital preparedness established
p.001213: under sec- tion 319C–2 or 319C–3.
p.001213: (2) ELIGIBLE TRAUMA CENTER.—The term ‘‘eligible trauma center’’ means a Level I, II, or III trauma center that
p.001213: satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma care
p.001213: pro- viders to provide trauma care and related acute care at such trauma center.
p.001213: (B) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (C) Such trauma center demonstrates a need for inte- grated military trauma care providers to maintain
p.001213: or im- prove the trauma clinical capability of such trauma center.
p.001213: (3) MAJOR TRAUMA.—The term ‘‘major trauma’’ means an injury that is greater than or equal to 15 on the injury
p.001213: severity score.
p.001213: (4) MILITARY TRAUMA TEAM.—The term ‘‘military trauma team’’ means a complete military trauma team
p.001213: consisting of military trauma care providers.
p.001213: (5) MILITARY TRAUMA CARE PROVIDER.—The term ‘‘military trauma care provider’’ means a member of the Armed
p.001213: Forces who furnishes emergency, critical care, and other trauma acute care services (including a physician, surgeon,
p.001213: physician assist- ant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic,
p.001213: or enlisted medical technician) or other military trauma care provider as the Secretary deter- mines
p.001213: appropriate.
p.001213: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated $11,500,000
p.001213: for each of fiscal years 2019 through 2023.
p.001213: TITLE XIII—HEALTH MAINTENANCE ORGANIZATIONS
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
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p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213:
p.001213: January 30, 2020
p.001213:
p.001213: REQUIREMENTS FOR HEALTH MAINTENANCE ORGANIZATIONS
p.001213: SEC. 1301. ø300e¿ (a) For purposes of this title, the term ‘‘health maintenance organization’’ means a public
p.001213: or private entity which is organized under the laws of any State and which (1) pro- vides basic and supplemental health
p.001213: services to its members in the manner prescribed by subsection (b), and (2) is organized and oper- ated in the manner
p.001213: prescribed by subsection (c).
p.001213: (b) A health maintenance organization shall provide, without limitations as to time or cost other than
p.001213: those prescribed by or under this title, basic and supplemental health services to its mem- bers in the following
p.001213: manner:
p.001213: (1) Each member is to be provided basic health services for a basic health services payment which (A) is to be
p.001213: paid on a periodic basis without regard to the dates health services (within the basic health
p.001213: services) are provided; (B) is fixed without regard to the frequency, extent, or kind of health serv-
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001213:
p.001213:
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p.001287: shall be deemed to have been paid to the State.
p.001287:
p.001287:
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p.001287:
p.001287:
p.001287:
p.001287:
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p.001287:
p.001287:
p.001287: January 30, 2020
p.001287: USE OF ALLOTMENTS
p.001287: SEC. 1904. ø300w–3¿ (a)(1) Except as provided in subsections
p.001287: (b) and (c), payments made to a State under section 1903 may be used for the following:
p.001287: (A) Activities consistent with making progress toward achieving the objectives established by the
p.001287: Secretary for the health status of the population of the United States for the year 2000 (in this part
p.001287: referred to as ‘‘year 2000 health objec- tives’’).
p.001287: (B) Preventive health service programs for the control of rodents and for community and school-based
p.001287: fluoridation pro- grams.
p.001287: (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and
p.001287: im- provement of such systems. Amounts for such systems may not be used for the costs of the operation of the systems
p.001287: or the pur- chase of equipment for the systems, except that such amounts may be used for the payment of not
p.001287: more than 50 percent of the costs of purchasing communications equipment for the sys- tems. Amounts may be expended
p.001287: for feasibility studies or plan- ning for the trauma-care components of such systems only if the studies or
p.001287: planning, respectively, is consistent with the re- quirements of section 1213(a).
p.001287: (D) Providing services to victims of sex offenses and for prevention of sex offenses.
p.001287: (E) The establishment, operation, and coordination of effec- tive and cost-efficient systems to reduce the
p.001287: prevalence of ill- ness due to asthma and asthma-related illnesses, especially among children, by reducing the
p.001287: level of exposure to cockroach allergen or other known asthma triggers through the use of in- tegrated pest
p.001287: management, as applied to cockroaches or other known allergens. Amounts expended for such systems may in- clude
p.001287: the costs of building maintenance and the costs of pro- grams to promote community participation in the
p.001287: carrying out at such sites of integrated pest management, as applied to
p.001287: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001287:
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p.001287:
p.001287: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1288
p.001287:
p.001287: cockroaches or other known allergens. For purposes of this sub- paragraph, the term ‘‘integrated pest management’’
p.001287: means an approach to the management of pests in public facilities that combines biological, cultural,
...

p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
p.001295: fact in con- nection with the furnishing of items or services for which pay- ment may be made by a State from funds
p.001295: allotted to the State under this part, or
p.001295: (2) having knowledge of the occurrence of any event affect- ing his initial or continued right to any such payment
p.001295: conceals or fails to disclose such event with an intent fraudulently to se- cure such payment either in a greater
p.001295: amount than is due or when no such payment is authorized,
p.001295: shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
p.001295:
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p.001295: January 30, 2020
p.001295: EMERGENCY MEDICAL SERVICES FOR CHILDREN
p.001295: SEC. 1910. ø300w–9¿ (a) For activities in addition to the activi- ties which may be carried out by States under section
p.001295: 1904(a)(1)(F), the Secretary may make grants to States or accredited schools of medicine in States to support
p.001295: a program of demonstration projects for the expansion and improvement of emergency medical services for
p.001295: children who need treatment for trauma or critical care. Any grant made under this subsection shall be
p.001295: for not more than a 4- year period (with an optional 5th year based on performance), sub- ject to annual
p.001295: evaluation by the Secretary. Only 3 grants under this subsection may be made in a State (to a State
p.001295: or to a school of medicine in such State) in any fiscal year.
p.001295: (b) The Secretary may renew a grant made under subsection
p.001295: (a) for one additional one-year period only if the Secretary deter- mines that renewal of such grant
p.001295: will provide significant benefits through the collection, analysis, and dissemination of information or data
p.001295: which will be useful to States in which grants under such subsection have not been made.
p.001295: (c) For purposes of this section—
p.001295: (1) the term ‘‘school of medicine’’ has the same meaning as in section 701(4); and
p.001295: (2) the term ‘‘accredited’’ has the same meaning as in sec- tion 701(5).
p.001295: (d) To carry out this section, there are authorized to be appro- priated $2,000,000 for fiscal year 1985 and for each
p.001295: of the two suc- ceeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000
p.001295: for each of the fiscal years 1991 and 1992, such sums as may be necessary for each of the fiscal
p.001295: years 1993 through 2005, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
p.001295: for fiscal year 2012, $28,940,625
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001295:
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p.001367:
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p.001367: January 30, 2020
p.001367:
p.001367: DETERMINATION OF ELIGIBILITY AND COMPENSATION
p.001367: SEC. 2113. ø300aa–13¿ (a) GENERAL RULE.—
p.001367: (1) Compensation shall be awarded under the Program to a petitioner if the special master or court
p.001367: finds on the record as a whole—
p.001367: (A) that the petitioner has demonstrated by a prepon- derance of the evidence the matters required in the
p.001367: peti- tion by section 2111(c)(1), and
p.001367: (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition,
p.001367: or death de- scribed in the petition is due to factors unrelated to the ad- ministration of the vaccine described in
p.001367: the petition.
p.001367: The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by
p.001367: medical records or by medical opinion.
p.001367: (2) For purposes of paragraph (1), the term ‘‘factors unre- lated to the administration of the vaccine’’—
p.001367: (A) does not include any idiopathic, unexplained, un- known, hypothetical, or undocumentable cause, factor,
p.001367: in- jury, illness, or condition, and
p.001367: (B) may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trau-
p.001367: ma (including birth trauma and related anoxia), or meta- bolic disturbances which have no known relation
p.001367: to the vaccine involved, but which in the particular case are shown to have been the agent or agents
p.001367: principally respon- sible for causing the petitioner’s illness, disability, injury, condition, or death.
p.001367: (b) MATTERS TO BE CONSIDERED.—
p.001367: (1) In determining whether to award compensation to a pe- titioner under the Program, the special master or
p.001367: court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
p.001367: (A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained
p.001367: in the record regarding the nature, causation, and aggravation of
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001367:
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p.001367:
p.001367: Sec. 2114 PUBLIC HEALTH SERVICE ACT 1368
p.001367:
p.001367: the petitioner’s illness, disability, injury, condition, or death, and
p.001367: (B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and
p.001367: conclusions.
p.001367: Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the
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p.001369: occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a
p.001369: fever of less than 102 degrees Fahrenheit, and
p.001369: (B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after
p.001369: administration of the vaccine and 2 or more seizures or convulsions oc- curred within 1 year after the
p.001369: administration of the vac- cine which were unaccompanied by fever or accompanied by a fever of less than 102
p.001369: degrees Fahrenheit.
p.001369: (3)(A) The term ‘‘encephalopathy’’ means any significant acquired abnormality of, or injury to, or impairment of
p.001369: function of the brain. Among the frequent manifestations of encephalopathy are focal and
p.001369: diffuse neurologic signs, in- creased intracranial pressure, or changes lasting at least 6 hours in
p.001369: level of consciousness, with or without convulsions. The neurological signs and symptoms of encephalopathy
p.001369: may be temporary with complete recovery, or may result in various degrees of permanent impairment. Signs and
p.001369: symptoms such as high pitched and unusual screaming, persistent unconsolable crying, and
p.001369: bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of
p.001369: encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram.
p.001369: (B) If in a proceeding on a petition it is shown by a prepon- derance of the evidence that an encephalopathy was caused
p.001369: by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be
p.001369: considered to be a condition set forth in the table. If at the time a judgment is entered on a
p.001369: petition filed under section 2111 for a vaccine-related injury or death it is not possible to determine the cause, by a
p.001369: preponder- ance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition
p.001369: set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the
p.001369: table, the court shall consider the entire med- ical record.
p.001369: (4) For purposes of paragraphs (2) and (3), the terms ‘‘sei- zure’’ and ‘‘convulsion’’ include grand mal, petit
p.001369: mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a provision of the table to
p.001369: which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d), such paragraph
p.001369: shall not apply to such provision after the effective date of the
p.001369: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001369:
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p.001369:
p.001369:
p.001371: 1371
p.001371: PUBLIC HEALTH SERVICE ACT
p.001371: Sec. 2114
p.001371:
p.001371: revision unless the revision specifies that such paragraph is to continue to apply.
p.001371: (c) ADMINISTRATIVE REVISION OF THE TABLE.—
p.001371: (1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury
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p.001621: responder sys- tems, including through—
p.001621: (A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities
p.001621: through drills and exercises, including drills and exercises to en- sure medical surge capacity for events
p.001621: without notice; and
p.001621: (B) integrating public and private sector public health and medical donations and volunteers.
p.001621: (2) PUBLIC HEALTH.—Developing and sustaining Federal, State, local, and tribal essential public health security
p.001621: capabili- ties, including the following:
p.001621: (A) Disease situational awareness domestically and abroad, including detection, identification, investigation,
p.001621: and related information technology activities.
p.001621: (B) Disease containment including capabilities for iso- lation, quarantine, social distancing,
p.001621: decontamination, rel- evant health care services and supplies, and transpor- tation and disposal of medical
p.001621: waste.
p.001621: (C) Risk communication and public preparedness.
p.001621: (D) Rapid distribution and administration of medical countermeasures.
p.001621: (E) Response to environmental hazards.
p.001621: (3) MEDICAL.—Increasing the preparedness, response capa- bilities, and surge capacity of hospitals, other health care
p.001621: facili- ties (including pharmacies, mental health facilities, and ambu- latory care facilities and which may
p.001621: include dental health fa- cilities), and trauma care, critical care, and emergency medical service systems, with
p.001621: respect to public health emergencies (in- cluding related availability, accessibility, and coordination),
p.001621: which shall include developing plans for the following:
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001621:
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p.001623: PUBLIC HEALTH SERVICE ACT
p.001623: Sec. 2802
p.001623:
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p.001623:
p.001623: January 30, 2020
p.001623: (A) Strengthening public health emergency medical and trauma management and treatment capabilities.
p.001623: (B) Fatality management.
p.001623: (C) Coordinated medical triage and evacuation to ap- propriate medical institutions based on patient
p.001623: medical need, taking into account regionalized systems of care.
p.001623: (D) Rapid distribution and administration of medical countermeasures.
p.001623: (E) Effective utilization of any available public and private mobile medical assets (which may include
p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
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p.001627: (2) have authority over and responsibility for—
p.001627: (A) the National Disaster Medical System pursuant to section 2812;
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001629: PUBLIC HEALTH SERVICE ACT
p.001629: Sec. 2811
p.001629:
p.001629: (B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2;
p.001629: (C) the Biomedical Advanced Research and Develop- ment Authority pursuant to section 319L;
p.001629: (D) the Medical Reserve Corps pursuant to section 2813;
p.001629: (E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and
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p.001629: January 30, 2020
p.001629: (F) administering grants and related authorities re- lated to trauma care under parts A through C of title XII,
p.001629: such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services
p.001629: Ad- ministration to such Assistant Secretary;
p.001629: (3) exercise the responsibilities and authorities of the Sec- retary with respect to the coordination of—
p.001629: (A) the Public Health Emergency Preparedness Coop- erative Agreement Program pursuant to section 319C–1;
p.001629: (B) the Strategic National Stockpile pursuant to sec- tion 319F–2; and
p.001629: (C) the Cities Readiness Initiative; and
p.001629: (4) assume other duties as determined appropriate by the Secretary.
p.001629: (d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
p.001629: (1) IN GENERAL.—Not later than March 15, 2020, and bien- nially thereafter, the Assistant Secretary for Preparedness
p.001629: and Response shall develop and submit to the appropriate commit- tees of Congress a coordinated strategy and
p.001629: accompanying im- plementation plan for medical countermeasures to address chemical, biological,
p.001629: radiological, and nuclear threats. In devel- oping such a plan, the Assistant Secretary for Preparedness and
p.001629: Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section
p.001629: 2811–1. Such strategy and plan shall be known as the ‘‘Public Health Emergency Medical Countermeasures Enterprise
p.001629: Strat- egy and Implementation Plan’’.
p.001629: (2) REQUIREMENTS.—The plan under paragraph (1) shall—
...

p.001633: and children, including related drills and exercises pursuant to the prepared- ness goals under section 2802(b).
p.001633: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001633: respect to chil- dren and the medical and public health grants and cooperative agreements as applicable
p.001633: to preparedness and response activities authorized under this title and title III.
p.001633: (d) MEMBERSHIP.—
p.001633: (1) IN GENERAL.—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint
p.001633: not to exceed 25 members to the Advisory Committee. In appointing such members, the Secretary shall ensure
p.001633: that the total mem- bership of the Advisory Committee is an odd number.
p.001633: (2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as
p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001709: (4) USE OF COOPERATIVE AGREEMENTS.—Any contract under this title between the WTC Program Administrator and
p.001709: a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.
p.001709: (5) REVIEW ON FEASIBILITY OF CONSOLIDATING DATA CEN- TERS.—Not later than July 1, 2011, the Comptroller General
p.001709: of the United States shall submit to the Committee on Energy and Commerce of the House of
p.001709: Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate a report
p.001709: on the feasibility of consolidating Data Centers into a single Data Center.
p.001709: (b) CENTERS OF EXCELLENCE.—
p.001709: (1) CLINICAL CENTERS OF EXCELLENCE.—
p.001709: (A) DEFINITION.—For purposes of this title, the term ‘‘Clinical Center of Excellence’’ means a Center
p.001709: that dem- onstrates to the satisfaction of the Administrator that the Center—
p.001709: (i) uses an integrated, centralized health care pro- vider approach to create a comprehensive suite of
p.001709: health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC sur-
p.001709: vivors, or certified-eligible WTC survivors;
p.001709: (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes
p.001709: health care providers who have been trained pursuant to section 3313(c);
p.001709: (iii) employs health care provider staff with exper- tise that includes, at a minimum, occupational medi- cine,
p.001709: environmental medicine, trauma-related psychi- atry and psychology, and social services counseling; and
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p.001709: (iv) meets such other requirements as specified by the Administrator.
p.001709: (B) CONTRACT REQUIREMENTS.—The WTC Program Administrator shall not enter into a contract with a Clin-
p.001709: ical Center of Excellence under subsection (a)(1) unless the Center agrees to do each of the following:
p.001709: (i) Establish a formal mechanism for consulting with and receiving input from representatives of eligi- ble
p.001709: populations receiving monitoring and treatment benefits under subtitle B from such Center.
p.001709: (ii) Coordinate monitoring and treatment benefits under subtitle B with routine medical care provided for
p.001709: the treatment of conditions other than WTC-re- lated health conditions.
p.001709: (iii) Collect and report to the corresponding Data Center data, including claims data, in accordance with
p.001709: section 3304(b).
p.001709: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001709:
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p.000017: cardiac arrest and the initial medical response, including defibrillation as necessary; and
p.000017: (3) consult with and counsel other Federal agencies where such devices are to be used.
p.000017: (d) DATE CERTAIN FOR ESTABLISHING GUIDELINES AND REC- OMMENDATIONS.—The Secretary shall comply with
p.000017: this section not later than 180 days after the date of the enactment of the Cardiac Arrest Survival Act of 2000.
p.000017: (e) DEFINITIONS.—For purposes of this section:
p.000017: (1) The term ‘‘automated external defibrillator device’’ has the meaning given such term in section 248.
p.000017: (2) The term ‘‘Federal building’’ includes a building or por- tion of a building leased or rented by a Federal agency,
p.000017: and in- cludes buildings on military installations of the United States.
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p.000017: January 30, 2020
p.000017: LIABILITY REGARDING EMERGENCY USE OF AUTOMATED EXTERNAL DEFIBRILLATORS
p.000017: SEC. 248. ø238q¿ (a) GOOD SAMARITAN PROTECTIONS REGARD-
p.000017: ING AEDS.—Except as provided in subsection (b), any person who uses or attempts to use an automated
p.000017: external defibrillator device on a victim of a perceived medical emergency is immune from civil liability for any
p.000017: harm resulting from the use or attempted use of such device; and in addition, any person who acquired
p.000017: the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device—
p.000017: (1) to notify local emergency response personnel or other appropriate entities of the most recent placement of
p.000017: the device within a reasonable period of time after the device was placed;
p.000017: (2) to properly maintain and test the device; or
p.000017: (3) to provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee
p.000017: or agent was the person who used the device on the victim, except that such requirement of training does not apply if—
p.000017: (A) the employee or agent was not an employee or agent who would have been reasonably expected to use the
p.000017: device; or
p.000017: (B) the period of time elapsing between the engage- ment of the person as an employee or agent and the occur-
p.000017: rence of the harm (or between the acquisition of the device and the occurrence of the harm, in any case in
p.000017: which the device was acquired after such engagement of the person) was not a reasonably sufficient period in
p.000017: which to provide the training.
p.000017: (b) INAPPLICABILITY OF IMMUNITY.—Immunity under subsection
p.000017: (a) does not apply to a person if—
p.000017: (1) the harm involved was caused by willful or criminal misconduct, gross negligence, reckless misconduct,
p.000017: or a con- scious, flagrant indifference to the rights or safety of the victim who was harmed;
p.000017: (2) the person is a licensed or certified health professional who used the automated external defibrillator device
p.000017: while act- ing within the scope of the license or certification of the profes-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 248 PUBLIC HEALTH SERVICE ACT 58
p.000017:
p.000017: sional and within the scope of the employment or agency of the professional;
p.000017: (3) the person is a hospital, clinic, or other entity whose purpose is providing health care directly
p.000017: to patients, and the harm was caused by an employee or agent of the entity who used the device while
p.000017: acting within the scope of the employ- ment or agency of the employee or agent; or
p.000017: (4) the person is an acquirer of the device who leased the device to a health care entity (or who
p.000017: otherwise provided the device to such entity for compensation without selling the de- vice to the
p.000017: entity), and the harm was caused by an employee or agent of the entity who used the device while acting within
p.000017: the scope of the employment or agency of the employee or agent.
p.000017: (c) RULES OF CONSTRUCTION.—
p.000017: (1) IN GENERAL.—The following applies with respect to this section:
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p.000539:
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p.000539: January 30, 2020
p.000539: (i) are designed to train medical, psychology, den- tal, social work, nursing, and other health profession
p.000539: students, interns, residents, fellows, or current health care providers to identify and provide health care serv-
p.000539: ices (including mental or behavioral health care serv- ices and referrals to appropriate community
p.000539: services) to individuals who are or who have been victims of do- mestic violence, dating violence, sexual
p.000539: assault, or stalking; and
p.000539: (ii) plan and develop culturally competent clinical training components for integration into approved in-
p.000539: ternship, residency, and fellowship training or con- tinuing medical or other health education training
p.000539: that address physical, mental, and behavioral health issues, including protective factors, related to domestic
p.000539: violence, dating violence, sexual assault, stalking, and other forms of violence and abuse, focus on reducing
p.000539: health disparities and preventing violence and abuse, and include the primacy of victim safety and confiden-
p.000539: tiality;
p.000539: (B) design and implement comprehensive strategies to improve the response of the health care system to domestic or
p.000539: sexual violence in clinical and public health settings, hospitals, clinics, and other health settings
p.000539: (including be- havioral and mental health), under subsection (a)(3) through—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: (i) the implementation, dissemination, and evalua- tion of policies and procedures to guide health profes-
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p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
p.000541: nonprofit victim advocacy organizations, State or trib- al law enforcement task forces (where appropriate), and
p.000541: population specific organizations with dem- onstrated expertise in domestic violence, dating vio-
p.000541: lence, sexual assault, or stalking;
p.000541: (iv) with respect to an application for a grant under which the grantee will have contact with pa-
p.000541: tients, a plan, developed in collaboration with local victim service providers, to respond appropriately
p.000541: to and make correct referrals for individuals who disclose that they are victims of domestic violence, dating
p.000541: vio- lence, sexual assault, stalking, or other types of vio- lence, and documentation provided by the
p.000541: grantee of an ongoing collaborative relationship with a local vic- tim service provider; and
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000541:
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p.000543: PUBLIC HEALTH SERVICE ACT
p.000543: Sec. 399P
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p.000543: (v) with respect to an application for a grant pro- posing to fund a program described in
p.000543: subsection (b)(2)(C)(ii), a certification that any sexual assault fo- rensic medical examination and sexual
p.000543: assault nurse examiner programs supported with such grant funds will adhere to the guidelines set forth by the
p.000543: Attorney General.
p.000543: (d) ELIGIBLE ENTITIES.—
p.000543: (1) IN GENERAL.—To be eligible to receive funding under paragraph (1) or (2) of subsection (a), an entity shall
p.000543: be—
p.000543: (A) a nonprofit organization with a history of effective work in the field of training health professionals
p.000543: with an understanding of, and clinical skills pertinent to, domestic violence, dating violence, sexual assault,
p.000543: or stalking, and lifetime exposure to violence and abuse;
p.000543: (B) an accredited school of allopathic or osteopathic medicine, psychology, nursing, dentistry, social work, or
p.000543: al- lied health;
p.000543: (C) a health care provider membership or professional organization, or a health care system; or
p.000543: (D) a State, tribal, territorial, or local entity.
p.000543: (2) SUBSECTION (A)(3) GRANTEES.—To be eligible to receive funding under subsection (a)(3), an entity shall be—
p.000543: (A) a State department (or other division) of health, a State, tribal, or territorial domestic violence or
p.000543: sexual as- sault coalition or victim service provider, or any other non- profit, nongovernmental organization with
p.000543: a history of ef- fective work in the fields of domestic violence, dating vio- lence, sexual assault, or
p.000543: stalking, and health care, includ- ing physical or mental health care; or
p.000543: (B) a local victim service provider, a local department (or other division) of health, a local health clinic,
p.000543: hospital, or health system, or any other community-based organiza- tion with a history of effective work in the field
p.000543: of domestic violence, dating violence, sexual assault, or stalking and health care, including physical or mental
p.000543: health care.
p.000543: (e) TECHNICAL ASSISTANCE.—
p.000543: (1) IN GENERAL.—Of the funds made available to carry out this section for any fiscal year, the Secretary may make
p.000543: grants or enter into contracts to provide technical assistance with re- spect to the planning, development, and
p.000543: operation of any pro- gram, activity or service carried out pursuant to this section. Not more than 8
p.000543: percent of the funds appropriated under this section in each fiscal year may be used to fund technical assist- ance
p.000543: under this subsection.
p.000543: (2) AVAILABILITY OF MATERIALS.—The Secretary shall make publicly available materials developed by grantees under
p.000543: this section, including materials on training, best practices, and re- search and evaluation.
p.000543: (3) REPORTING.—The Secretary shall publish a biennial re- port on—
p.000543: (A) the distribution of funds under this section; and
p.000543: (B) the programs and activities supported by such funds.
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001123: Sec. 917 PUBLIC HEALTH SERVICE ACT 1124
p.001123:
p.001123: the victims referred to in paragraph (1), and of other appro- priate public and private entities
p.001123: (including medical societies, victim services organizations, sexual assault prevention organi- zations, and social
p.001123: services organizations).
p.001123: SEC. 917. ø299b–6¿ COORDINATION OF FEDERAL GOVERNMENT QUAL- ITY IMPROVEMENT EFFORTS.
p.001123: (a) REQUIREMENT.—
p.001123: (1) IN GENERAL.—To avoid duplication and ensure that Federal resources are used efficiently and
p.001123: effectively, the Sec- retary, acting through the Director, shall coordinate all re- search, evaluations, and
p.001123: demonstrations related to health serv- ices research, quality measurement and quality improvement activities
p.001123: undertaken and supported by the Federal Govern- ment.
p.001123: (2) SPECIFIC ACTIVITIES.—The Director, in collaboration with the appropriate Federal officials
p.001123: representing all con- cerned executive agencies and departments, shall develop and manage a process to—
p.001123: (A) improve interagency coordination, priority setting, and the use and sharing of research findings and data per-
p.001123: taining to Federal quality improvement programs, tech- nology assessment, and health services research;
p.001123: (B) strengthen the research information infrastruc- ture, including databases, pertaining to Federal
p.001123: health services research and health care quality improvement ini- tiatives;
p.001123: (C) set specific goals for participating agencies and de- partments to further health services research and
p.001123: health care quality improvement; and
p.001123: (D) strengthen the management of Federal health care quality improvement programs.
p.001123: (b) STUDY BY THE INSTITUTE OF MEDICINE.—
p.001123: (1) IN GENERAL.—To provide Congress, the Department of Health and Human Services, and other relevant
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p.001289: (5)(A) The State agrees that, in the case of each population for which such strategy is carried out, the State
p.001289: will measure the extent of progress being made toward improving the health status of the population.
p.001289: (B) The State agrees that—
p.001289: (i) the State will collect and report data in accordance with section 1906(a); and
p.001289: (ii) for purposes of subparagraph (A), progress will be measured through use of each of the applicable
p.001289: uniform data items developed by the Secretary under paragraph (2) of such section, or if no such items are applicable,
p.001289: through use of the uniform criteria developed by the Secretary under paragraph (3) of such section.
p.001289: (6) With respect to the activities authorized in section 1904, the State agrees to maintain State expenditures
p.001289: for such activities at a level that is not less than the average level of such expenditures maintained
p.001289: by the State for the 2-year pe- riod preceding the fiscal year for which the State is applying to
p.001289: receive payments under section 1903.
p.001289: (7) The State agrees to establish reasonable criteria to evaluate the effective performance of
p.001289: entities that receive funds from such payments and procedures for procedural and substantive independent
p.001289: State review of the failure by the State to provide funds for any such entity.
p.001289: (8) The State agrees to permit and cooperate with Federal investigations undertaken in accordance with section 1907.
p.001289: (9) The State has in effect a system to protect from inap- propriate disclosure patient and sex offense
p.001289: victim records maintained by the State in connection with an activity funded under this part or by any entity
p.001289: which is receiving payments from the allotment of the State under this part.
p.001289: (10) The State agrees to provide the officer of the State government responsible for the administration
p.001289: of the State highway safety program with an opportunity to—
p.001289: (A) participate in the development of any plan by the State relating to emergency medical services, as such
p.001289: plan relates to highway safety; and
p.001289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001289:
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p.001291: 1291
p.001291: PUBLIC HEALTH SERVICE ACT
p.001291: Sec. 1906
p.001291:
p.001291: (B) review and comment on any proposal by any State agency to use any Federal grant or Federal payment re-
p.001291: ceived by the State for the provision of emergency medical services as such proposal relates to highway safety.
p.001291: (d) STATE ADVISORY COMMITTEE.—
p.001291: (1) IN GENERAL.—For purposes of subsection (c)(2), an ad- visory committee is in accordance with this
p.001291: subsection if such committee is known as the State Preventive Health Advisory Committee (in this
p.001291: subsection referred to as the ‘‘Committee’’) and the Committee meets the conditions described in the sub- sequent
p.001291: paragraphs of this subsection.
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p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001351: (ii) in the case of a pregnant unemancipated minor re- questing services from the applicant, the applicant will no-
p.001351: tify the parents or guardians of such minor under clause
p.001351: (i) within a reasonable period of time;
p.001351: (B) assurances that the applicant will not notify or request the permission of the parents or
p.001351: guardian of any unemancipated minor without the consent of the minor—
p.001351: (i) who solely is requesting from the applicant preg- nancy testing or testing or treatment for venereal
p.001351: disease;
p.001351: (ii) who is the victim of incest involving a parent; or
p.001351: (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor
p.001351: by blood certifies to the grantee that notification of the parents or guardians of such minor would result in
p.001351: physical injury to such minor; and
p.001351: (C) assurances that the applicant will not require, with re- spect to the provision of services, the permission of the
p.001351: parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to
p.001351: compel such minor to have an abortion;
p.001351: (23) assurances that primary emphasis for services sup- ported under this title shall be given to
p.001351: adolescents seventeen and under who are not able to obtain needed assistance through other means;
p.001351: (24) assurances that funds received under this title shall supplement and not supplant funds received
p.001351: from any other Federal, State, or local program or any private sources of funds; and
p.001351: (25) a plan for the conduct of, and assurances that the ap- plicant will conduct, evaluations of the
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p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
p.001531: (b) SPECIFICATION OF AIRBORNE INFECTIOUS DISEASES.—The list developed by the Secretary under subsection (a)(1)
p.001531: shall include a specification of those infectious diseases on the list that are rou- tinely transmitted through
p.001531: airborne or aerosolized means.
p.001531: (c) DISSEMINATION.—The Secretary shall—
p.001531: (1) transmit to State public health officers copies of the list and guidelines developed by the Secretary under
p.001531: subsection (a) with the request that the officers disseminate such copies as appropriate throughout the
p.001531: States; and
p.001531: (2) make such copies available to the public.
p.001531: SEC. 2695A. ø300ff–132¿ ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE INFECTIOUS DISEASES IN VICTIMS ASSISTED.
p.001531: (a) ROUTINE NOTIFICATION OF DESIGNATED OFFICER.—
p.001531: (1) DETERMINATION BY TREATING FACILITY.—If a victim of an emergency is transported by emergency response
p.001531: employees to a medical facility and the medical facility makes a deter- mination that the victim has an
p.001531: airborne infectious disease,
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001531:
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p.001531: Sec. 2695B PUBLIC HEALTH SERVICE ACT 1532
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p.001531: the medical facility shall notify the designated officer of the emergency response employees who
p.001531: transported the victim to the medical facility of the determination.
p.001531: (2) DETERMINATION BY FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim of an emergency is transported
p.001531: by emer- gency response employees to a medical facility and the victim dies at or before reaching the
p.001531: medical facility, the medical fa- cility ascertaining the cause of death shall notify the des- ignated
p.001531: officer of the emergency response employees who trans- ported the victim to the initial medical facility of
p.001531: any deter- mination by the medical facility that the victim had an air- borne infectious disease.
p.001531: (b) REQUIREMENT OF PROMPT NOTIFICATION.—With respect to a determination described in paragraph (1) or (2) of
p.001531: subsection (a), the notification required in each of such paragraphs shall be made as soon as is practicable, but not
p.001531: later than 48 hours after the de- termination is made.
p.001531: SEC. 2695B. ø300ff–133¿ REQUEST FOR NOTIFICATION WITH RESPECT TO VICTIMS ASSISTED.
p.001531: (a) INITIATION OF PROCESS BY EMPLOYEE.—If an emergency re- sponse employee believes that the employee may
p.001531: have been ex- posed to an infectious disease by a victim of an emergency who was transported to a medical facility as
p.001531: a result of the emergency, and if the employee attended, treated, assisted, or transported the vic- tim
p.001531: pursuant to the emergency, then the designated officer of the employee shall, upon the request of the
p.001531: employee, carry out the du- ties described in subsection (b) regarding a determination of wheth- er the employee may
p.001531: have been exposed to an infectious disease by the victim.
p.001531: (b) INITIAL DETERMINATION BY DESIGNATED OFFICER.—The du- ties referred to in subsection (a) are that—
p.001531: (1) the designated officer involved collect the facts relating to the circumstances under which, for purposes of
p.001531: subsection (a), the employee involved may have been exposed to an infec- tious disease; and
p.001531: (2) the designated officer evaluate such facts and make a determination of whether, if the victim involved had
p.001531: any infec- tious disease included on the list issued under paragraph (1) of section 2695(a), the employee
p.001531: would have been exposed to the disease under such facts, as indicated by the guidelines issued under
p.001531: paragraph (2) of such section.
p.001531: (c) SUBMISSION OF REQUEST TO MEDICAL FACILITY.—
p.001531: (1) IN GENERAL.—If a designated officer makes a deter- mination under subsection (b)(2) that an emergency
p.001531: response employee may have been exposed to an infectious disease, the designated officer shall submit to the
p.001531: medical facility to which the victim involved was transported a request for a response under subsection (d)
p.001531: regarding the victim of the emergency in- volved.
p.001531: (2) FORM OF REQUEST.—A request under paragraph (1) shall be in writing and be signed by the designated
p.001531: officer in- volved, and shall contain a statement of the facts collected pur- suant to subsection (b)(1).
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: 1533
p.001533: PUBLIC HEALTH SERVICE ACT
p.001533: Sec. 2695B
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p.001533: January 30, 2020
p.001533: (d) EVALUATION AND RESPONSE REGARDING REQUEST TO MED-
p.001533: ICAL FACILITY.—
p.001533: (1) IN GENERAL.—If a medical facility receives a request under subsection (c), the medical facility shall
p.001533: evaluate the facts submitted in the request and make a determination of whether, on the basis of the medical
p.001533: information possessed by the facility regarding the victim involved, the emergency re- sponse employee was
p.001533: exposed to an infectious disease included on the list issued under paragraph (1) of section 2695(a), as in- dicated by
p.001533: the guidelines issued under paragraph (2) of such section.
p.001533: (2) NOTIFICATION OF EXPOSURE.—If a medical facility makes a determination under paragraph (1) that
p.001533: the emer- gency response employee involved has been exposed to an in- fectious disease, the medical facility
p.001533: shall, in writing, notify the designated officer who submitted the request under subsection
p.001533: (c) of the determination.
p.001533: (3) FINDING OF NO EXPOSURE.—If a medical facility makes a determination under paragraph (1) that the
p.001533: emergency re- sponse employee involved has not been exposed to an infectious disease, the medical facility shall,
p.001533: in writing, inform the des- ignated officer who submitted the request under subsection (c) of the determination.
p.001533: (4) INSUFFICIENT INFORMATION.—
p.001533: (A) If a medical facility finds in evaluating facts for purposes of paragraph (1) that the facts are
p.001533: insufficient to make the determination described in such paragraph, the medical facility shall, in writing,
p.001533: inform the designated of- ficer who submitted the request under subsection (c) of the insufficiency of the facts.
p.001533: (B)(i) If a medical facility finds in making a deter- mination under paragraph (1) that the facility possesses
p.001533: no information on whether the victim involved has an infec- tious disease included on the list under
p.001533: section 2695(a), the medical facility shall, in writing, inform the designated officer who submitted the request
p.001533: under subsection (c) of the insufficiency of such medical information.
p.001533: (ii) If after making a response under clause (i) a med- ical facility determines that the victim involved has an in-
p.001533: fectious disease, the medical facility shall make the deter- mination described in paragraph (1) and provide the appli-
p.001533: cable response specified in this subsection.
p.001533: (e) TIME FOR MAKING RESPONSE.—After receiving a request under subsection (c) (including any such request
p.001533: resubmitted under subsection (g)(2)), a medical facility shall make the applicable re- sponse specified in
p.001533: subsection (d) as soon as is practicable, but not later than 48 hours after receiving the request.
p.001533: (f) DEATH OF VICTIM OF EMERGENCY.—
p.001533: (1) FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim described in subsection (a) dies at or before reaching the
p.001533: med- ical facility involved, and the medical facility receives a request under subsection (c), the medical
p.001533: facility shall provide a copy of the request to the medical facility ascertaining the cause of
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: death of the victim, if such facility is a different medical facil- ity than the facility that received the original
p.001533: request.
p.001533: (2) RESPONSIBILITY OF FACILITY.—Upon the receipt of a copy of a request for purposes of paragraph (1), the
p.001533: duties oth- erwise established in this part regarding medical facilities shall apply to the medical
p.001533: facility ascertaining the cause of death of the victim in the same manner and to the same extent as such duties
p.001533: apply to the medical facility originally receiving the request.
p.001533: (g) ASSISTANCE OF PUBLIC HEALTH OFFICER.—
p.001533: (1) EVALUATION OF RESPONSE OF MEDICAL FACILITY RE- GARDING INSUFFICIENT FACTS.—
p.001533: (A) In the case of a request under subsection (c) to which a medical facility has made the response specified
p.001533: in subsection (d)(4)(A) regarding the insufficiency of facts, the public health officer for the community in which the
p.001533: med- ical facility is located shall evaluate the request and the response, if the designated officer
p.001533: involved submits such documents to the officer with the request that the officer make such an evaluation.
p.001533: (B) As soon as is practicable after a public health offi- cer receives a request under subparagraph (A), but
p.001533: not later than 48 hours after receipt of the request, the public health officer shall complete the evaluation
p.001533: required in such paragraph and inform the designated officer of the re- sults of the evaluation.
p.001533: (2) FINDINGS OF EVALUATION.—
p.001533: (A) If an evaluation under paragraph (1)(A) indicates that the facts provided to the medical facility
p.001533: pursuant to subsection (c) were sufficient for purposes of determina- tions under subsection (d)(1)—
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p.001533: facil- ity were insufficient for purposes of determinations speci- fied in subsection (c)—
p.001533: (i) the public health officer shall provide advice to the designated officer regarding the collection and de- scription
p.001533: of appropriate facts; and
p.001533: (ii) if sufficient facts are obtained by the des- ignated officer—
p.001533: (I) the public health officer shall, on behalf of the designated officer involved, resubmit the re- quest to the
p.001533: medical facility; and
p.001533: (II) the medical facility shall provide to the designated officer the appropriate response under subsection
p.001533: (c).
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: 1535
p.001535: PUBLIC HEALTH SERVICE ACT
p.001535: Sec. 2695E
p.001535:
p.001535: SEC. 2695C. ø300ff–134¿ PROCEDURES FOR NOTIFICATION OF EXPO- SURE.
p.001535: (a) CONTENTS OF NOTIFICATION TO OFFICER.—In making a no- tification required under section 2695A or section
p.001535: 2695B(d)(2), a medical facility shall provide—
p.001535: (1) the name of the infectious disease involved; and
p.001535: (2) the date on which the victim of the emergency involved was transported by emergency response employees to the med-
p.001535: ical facility involved.
p.001535: (b) MANNER OF NOTIFICATION.—If a notification under section 2695A or section 2695B(d)(2) is mailed or
p.001535: otherwise indirectly made—
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p.001535: (1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer
p.001535: to whom the notification is sent of the fact that the notification has been sent; and
p.001535: (2) such designated officer shall, not later than 10 days after being informed by the medical facility
p.001535: that the notifica- tion has been sent, inform such medical facility whether the designated officer has
p.001535: received the notification.
p.001535: SEC. 2695D. ø300ff–135¿ NOTIFICATION OF EMPLOYEE.
p.001535: (a) IN GENERAL.—After receiving a notification for purposes of section 2695A or 2695B(d)(2), a designated officer of
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p.001535: (b) PREFERENCE IN MAKING DESIGNATIONS.—In making the designations required in subsection (a), a public health
p.001535: officer shall give preference to individuals who are trained in the provision of health care or in the
p.001535: control of infectious diseases.
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: Sec. 2695F PUBLIC HEALTH SERVICE ACT 1536
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p.001535: January 30, 2020
p.001535:
p.001535: SEC. 2695F. ø300ff–137¿ LIMITATION WITH RESPECT TO DUTIES OF MEDICAL FACILITIES.
p.001535: The duties established in this part for a medical facility—
p.001535: (1) shall apply only to medical information possessed by the facility during the period in which the
p.001535: facility is treating the victim for conditions arising from the emergency, or during the 60-day period beginning
p.001535: on the date on which the victim is transported by emergency response employees to the facility, whichever period
p.001535: expires first; and
p.001535: (2) shall not apply to any extent after the expiration of the 30-day period beginning on the expiration of the
p.001535: applicable pe- riod referred to in paragraph (1), except that such duties shall apply with respect to any request
p.001535: under section 2695B(c) re- ceived by a medical facility before the expiration of such 30-day period.
p.001535: SEC. 2695G. ø300ff–138¿ MISCELLANEOUS PROVISIONS.
p.001535: (a) LIABILITY OF MEDICAL FACILITIES, DESIGNATED OFFICERS, PUBLIC HEALTH OFFICERS, AND GOVERNING
p.001535: ENTITIES.—This part may not be construed to authorize any cause of action for damages or any civil penalty against any
p.001535: medical facility, any designated of- ficer, any other public health officer, or any governing entity of such
p.001535: facility or officer for failure to comply with the duties estab- lished in this part.
p.001535: (b) TESTING.—This part may not, with respect to victims of emergencies, be construed to authorize or require a
p.001535: medical facility to test any such victim for any infectious disease.
p.001535: (c) CONFIDENTIALITY.—This part may not be construed to au- thorize or require any medical facility, any
p.001535: designated officer of emergency response employees, or any such employee, to disclose identifying information
p.001535: with respect to a victim of an emergency or with respect to an emergency response employee.
p.001535: (d) FAILURE TO PROVIDE EMERGENCY SERVICES.—This part may not be construed to authorize any emergency
p.001535: response em- ployee to fail to respond, or to deny services, to any victim of an emergency.
p.001535: (e) NOTIFICATION AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or
p.001535: partially as a result of a public health emergency that has been determined pursuant to section 319(a),
p.001535: individuals or public or private entities are un- able to comply with the requirements of this part,
p.001535: the Secretary may, notwithstanding any other provision of law, temporarily sus- pend, in whole or in part, the
p.001535: requirements of this part as the cir- cumstances reasonably require. Before or promptly after such a
p.001535: suspension, the Secretary shall notify the Congress of such action and publish in the Federal Register a
p.001535: notice of the suspension.
p.001535: (f) CONTINUED APPLICATION OF STATE AND LOCAL LAW.—Noth- ing in this part shall be construed to limit the
p.001535: application of State or local laws that require the provision of data to public health au- thorities.
p.001535: SEC. 2695H. ø300ff–139¿ INJUNCTIONS REGARDING VIOLATION OF PRO- HIBITION.
p.001535: (a) IN GENERAL.—The Secretary may, in any court of com- petent jurisdiction, commence a civil action for
p.001535: the purpose of ob-
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
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p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were
p.000001: all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan
p.000001: abolished the National Institutes of Health as an agency, it did not abolish the individual research
p.000001: institutes.
p.000001: In 1985, Public Law 99–158 added title IV of this Act, which provides that the National Insti- tutes of Health is an
p.000001: agency of the Public Health Service. See section 401(a).
p.000001: Other laws have established additional agencies within the Service. Section 501(a) of this Act provides that the
p.000001: Substance Abuse and Mental Health Services Administration is an agency of the Service. Section 901(a) establishes
p.000001: the Agency for Healthcare Research and Quality within the Service (formerly designated as the Agency for Health
p.000001: Care Policy and Research).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 3 PUBLIC HEALTH SERVICE ACT Sec. 203
p.000001:
p.000001: Bureau of Medical Services, and (4) the Bureau of State Services, and the Agency for Health Care Policy
p.000001: and Research. 2 The Sec- retary is authorized and directed to assign to the Office of the Sec- retary, to the
p.000001: National Institutes of Health, to the Bureau of Med- ical Services, and to the Bureau of State Services, respectively,
p.000001: the several functions of the Service, and to establish within them such divisions, sections and other units as he
p.000001: may find necessary; and from time to time, abolish, transfer, and consolidate divisions, sec- tions, and other
p.000001: units and assign their functions and personnel in such manner as he may find necessary for efficient operation
p.000001: of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated,
p.000001: except with the approval of the Secretary. The National Institutes of Health shall be adminis- tered as a
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p.000001: case shall the total paid to any such employee for any fiscal year exceed the
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 209 PUBLIC HEALTH SERVICE ACT 12
p.000001:
p.000001: amount of the minimum annual salary rate of the classification grade of the employee.
p.000001: (e) Any civilian employee of the Service who is employed at the Gillis W. Long Hansen’s Disease Center on the
p.000001: date of the enact- ment of the Consolidated Omnibus Budget Reconciliation Act of 1985 shall be entitled
p.000001: to receive, in addition to any compensation to which the employee may otherwise be entitled and for so
p.000001: long as the employee remains employed at the Center, an amount equal to one-fourth of such compensation.
p.000001: (f) Individuals appointed under subsection (g) shall have in- cluded in their fellowships such stipends
p.000001: or allowances, including travel and subsistence expenses, as the Surgeon General may deem necessary to procure
p.000001: qualified fellows.
p.000001: (g) The Secretary is authorized to establish and fix the com- pensation for, within the Public Health
p.000001: Service, not more than one hundred and seventy-nine positions, of which not less than one hundred and fifteen
p.000001: shall be for the National Institutes of Health, not less than five shall be for the National Institute on
p.000001: Alcohol Abuse and Alcoholism for individuals engaged in research on alco- hol and alcoholism, not less than ten shall
p.000001: be for the National Cen- ter for Health Services Research, not less than twelve shall be for the National
p.000001: Center for Health Statistics, and not less than seven shall be for the National Center for Health Care
p.000001: Technology, in the professional, scientific, and executive service, each such position being established to
p.000001: effectuate those research and development ac- tivities of the Public Health Service which require the services
p.000001: of specially qualified scientific, professional, and administrative per- sonnel: Provided, That the rates
p.000001: of compensation for positions es- tablished pursuant to the provisions of this subsection shall not be less than
p.000001: the minimum rate of grade 16 of the General Schedule of the Classification Act of 1949, as amended, 5
p.000001: nor more than (1) the highest rate of grade 18 of the General Schedule of such Act, or (2) in the
p.000001: case of two such positions, the rate specified, at the time the service in the position is performed, for
p.000001: level II of the Ex- ecutive Schedule (5 U.S.C. 5313); and such rates of compensation for all positions
p.000001: included in this proviso shall be subject to the ap- proval of the Civil Service Commission. Positions created pursuant
p.000001: to this subsection shall be included in the classified civil service of the United States, but appointments to
p.000001: such positions shall be made without competitive examination upon approval of the pro- posed appointee’s
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p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
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p.000017: 17
p.000017: MONEY COLLECTED FOR CARE OF PATIENTS
p.000017: SEC. 233. ø238b¿ Money collected as provided by law for ex- penses incurred in the care and treatment
p.000017: of foreign seamen, and money received for the care and treatment of pay patients, includ- ing any amounts
p.000017: received from any executive department on ac- count of care and treatment of pay patients, shall be
p.000017: covered into the appropriation from which the expenses of such care and treat- ment were paid.
p.000017: TRANSPORTATION OF REMAINS OF OFFICERS
p.000017: SEC. 234. ø238c¿ Appropriations available for traveling ex- penses of the Service shall be available for
p.000017: meeting the cost of preparation for burial and of transportation to the place of burial of remains of
p.000017: commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations
p.000017: available for carrying out the provisions of this Act shall also be available for the payment of such
p.000017: expenses relating to the recovery, care, and disposition of the remains of personnel or their dependents as may
p.000017: be authorized under other provisions of law.
p.000017: GRANTS TO FEDERAL INSTITUTIONS
p.000017: SEC. 235. ø238d¿ Appropriations to the Public Health Service available under this Act for research,
p.000017: training, or demonstration project grants or for grants to expand existing treatment and re- search
p.000017: programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations
p.000017: under title VI of the Mental Health Systems Act shall also be available, on the same terms and conditions as
p.000017: apply to non-Federal institutions, for grants for the same purpose to Federal institutions, except that grants
p.000017: to such Federal institutions may be funded at 100 per cen- tum of the costs.
p.000017: TRANSFER OF FUNDS
p.000017: SEC. 236. ø238e¿ For the purpose of any reorganization under section 202, the Secretary, with the approval of the
p.000017: Director of the Bureau of the Budget, 18 is authorized to make such transfers of funds between
p.000017: appropriations as may be necessary for the continu- ance of transferred functions.
p.000017:
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p.000017: January 30, 2020
p.000017: 17 Subsection (a) of section 322 was repealed by section 986 of Public Law 97–35, and the Pub- lic Law redesignated
p.000017: former subsection (c) as subsection (a). Section 232 (above) was enacted before this repeal and
p.000017: redesignation. Current section 322(a) authorizes the treatment and care of certain persons. (Section 232 was
p.000017: originally enacted as section 502, and was subsequently re- designated by Public Laws 98–24, 99–660, 100–690, and
p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: information during the conduct of research by the National Institutes of Health.
p.000017: (h)(1) The Secretary may make available to individuals and en- tities, for biomedical and behavioral research,
p.000017: substances and liv- ing organisms. Such substances and organisms shall be made available under such
p.000017: terms and conditions (including payment for them) as the Secretary determines appropriate.
p.000017: (2) Where research substances and living organisms are made available under paragraph (1) through
p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
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p.000017: January 30, 2020
p.000017: NARCOTICS
p.000017: SEC. 302. ø242¿ (a) In carrying out the purposes of section 301 with respect to drugs the use or misuse of
p.000017: which might result in drug abuse or dependency, the studies and investigations author- ized therein shall
p.000017: include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further
p.000017: include the quantities of crude opium, coca leaves, and their salts, deriva- tives, and preparations, and
p.000017: other drugs subject to control under the Controlled Substances Act and Controlled Substances Import and
p.000017: Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific
p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000117: in the United States;
p.000117: (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings
p.000117: docu- mented as having a high risk for tuberculosis; and
p.000117: (F) tuberculosis detection, control, and prevention.
p.000117: (4) Public information and education activities.
p.000117: (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention
p.000117: for health profes- sionals, including allied health personnel and emergency re- sponse employees.
p.000117: (6) Support of Centers to carry out activities under para- graphs (1) through (4).
p.000117: (7) Collaboration with international organizations and for- eign countries in carrying out such activities.
p.000117: (8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance
p.000117: and database management systems with cross-jurisdictional capa- bilities, which shall conform to the standards
p.000117: and implementa- tion specifications for such information technologies as rec- ommended by the Secretary.
p.000117: (c) COOPERATION WITH PROVIDERS OF PRIMARY HEALTH SERV- ICES.—The Secretary may make a grant under subsection (a)
p.000117: or (b) only if the applicant for the grant agrees that, in carrying out ac- tivities under the grant,
p.000117: the applicant will cooperate with public and nonprofit private providers of primary health services or
p.000117: sub- stance abuse services, including entities receiving assistance under section 329, 330, or 340A or under title V or
p.000117: XIX.
p.000117: (d) APPLICATION FOR GRANT.—
p.000117: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) or (b) only if an application for the grant
p.000117: is sub-
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000119: PUBLIC HEALTH SERVICE ACT
p.000119: Sec. 317E
p.000119:
p.000119: mitted to the Secretary and the application, subject to para- graph (2), is in such form, is made in
p.000119: such manner, and con- tains such agreements, assurances, and information as the Sec- retary determines to be
p.000119: necessary to carry out the subsection involved.
p.000119: (2) PLAN FOR PREVENTION, CONTROL, AND ELIMINATION.— The Secretary may make a grant under subsection (a)
p.000119: only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of
p.000119: tuberculosis in the geographic area with respect to which the grant is sought.
p.000119: (3) DETERMINATION OF AMOUNT OF NONFEDERAL CONTRIBU- TIONS.—
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p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
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p.000129: Sec. 317L PUBLIC HEALTH SERVICE ACT 130
p.000129:
p.000129: (1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the
p.000129: Indian Self- Determination and Education Assistance Act;
p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: 131
p.000131: PUBLIC HEALTH SERVICE ACT
p.000131: Sec. 317L–1
p.000131:
p.000131: (C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
p.000131: (b) GRANTS.—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States,
p.000131: local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and
p.000131: other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties.
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p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
p.000131: (1) provide technical and consultative assistance to entities receiving grants under subsection (b);
p.000131: (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease
p.000131: Control and Pre- vention;
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p.000263: January 30, 2020
p.000263:
p.000263: the applicants involved to the medically underserved populations in urban areas which may be expected to
p.000263: use the services provided by the applicants is not less than two to three or greater than three to two.
p.000263: (iv) SERVICE AREA OVERLAP.—If in carrying out clause (i) the applicant proposes to serve an area that is
p.000263: currently served by another health center funded under this section, the Secretary may consider wheth- er the
p.000263: award of funding to an additional health center in the area can be justified based on the unmet need for
p.000263: additional services within the catchment area.
p.000263: (B) APPROVAL OF EXPANDED SERVICE APPLICATIONS.—
p.000263: (i) IN GENERAL.—The Secretary may approve ap- plications for grants under subparagraph (A) or (B) of paragraph
p.000263: (1) to expand the capacity of the applicant to provide required primary health services described in
p.000263: subsection (b)(1) or additional health services de- scribed in subsection (b)(2).
p.000263: (ii) PRIORITY EXPANSION PROJECTS.—In carrying out clause (i), the Secretary may give special consider- ation to
p.000263: expanded service applications that seek to ad- dress emerging public health or behavioral health, mental health,
p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
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p.000265: junct to or part of a commodity grown in or on, the land; and
p.000265: (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to
p.000265: carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an
p.000265: activity described in clause (ii).
p.000265: (h) HOMELESS POPULATION.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of homeless
p.000265: individuals, including grants for innovative programs that provide outreach and com- prehensive primary health
p.000265: services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and
p.000265: veterans at risk of homelessness.
p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
p.000265: (A) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ means an individual who lacks housing (without
p.000265: regard to whether the individual is a member of a family), including an individual whose primary residence during
p.000265: the night is a supervised public or private facility that pro- vides temporary living accommodations and an
p.000265: individual who is a resident in transitional housing.
p.000265: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000267: 267
p.000267: PUBLIC HEALTH SERVICE ACT
p.000267: Sec. 330
p.000267:
p.000267: (B) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘substance abuse 31services’’ includes detoxification,
p.000267: risk reduction, outpatient treatment, residential treatment, and rehabilitation for substance abuse 31 provided
p.000267: in settings other than hospitals.
p.000267: (i) RESIDENTS OF PUBLIC HOUSING.—
p.000267: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000267: the plan- ning and delivery of services to a special medically under- served population comprised of
p.000267: residents of public housing (such term, for purposes of this subsection, shall have the same meaning given such term
p.000267: in section 3(b)(1) of the United States Housing Act of 1937) and individuals living in areas imme- diately
p.000267: accessible to such public housing.
p.000267: (2) SUPPLEMENT NOT SUPPLANT.—A grant awarded under this subsection shall be expended to supplement, and not
p.000267: sup- plant, the expenditures of the health center and the value of in kind contributions for the
p.000267: delivery of services to the popu- lation described in paragraph (1).
p.000267: (3) CONSULTATION WITH RESIDENTS.—The Secretary may not make a grant under paragraph (1) unless, with
p.000267: respect to the residents of the public housing involved, the applicant for the grant—
p.000267: (A) has consulted with the residents in the prepara- tion of the application for the grant; and
p.000267: (B) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the
p.000267: program carried out with the grant.
p.000267: (j) ACCESS GRANTS.—
p.000267: (1) IN GENERAL.—The Secretary may award grants to eligi- ble health centers with a substantial number of
p.000267: clients with limited English speaking proficiency to provide translation, in- terpretation, and other such services
p.000267: for such clients with lim- ited English speaking proficiency.
p.000267: (2) ELIGIBLE HEALTH CENTER.—In this subsection, the term ‘‘eligible health center’’ means an entity that—
p.000267: (A) is a health center as defined under subsection (a);
p.000267: (B) provides health care services for clients for whom English is a second language; and
p.000267: (C) has exceptional needs with respect to linguistic ac- cess or faces exceptional challenges with respect to
p.000267: lin- guistic access.
p.000267: (3) GRANT AMOUNT.—The amount of a grant awarded to a center under this subsection shall be determined by the
p.000267: Ad- ministrator. Such determination of such amount shall be based on the number of clients for whom English is
p.000267: a second lan- guage that is served by such center, and larger grant amounts shall be awarded to centers serving
p.000267: larger numbers of such cli- ents.
p.000267:
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p.000267: January 30, 2020
p.000267: 31 Section 50901(b)(8)(B)(iii)(II) of division E of Public Law 115–123 provides for an amend- ment to
p.000267: strike ‘‘abuse’’ and insert ‘‘use disorder’’. The term ‘‘abuse’’ appears twice and, as such, the amendment has not been
p.000267: carried out above.
p.000267: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000267: Sec. 330 PUBLIC HEALTH SERVICE ACT 268
p.000267:
p.000267: (4) USE OF FUNDS.—An eligible health center that receives a grant under this subsection may use funds received
p.000267: through such grant to—
p.000267: (A) provide translation, interpretation, and other such services for clients for whom English is a second language,
p.000267: including hiring professional translation and interpreta- tion services; and
p.000267: (B) compensate bilingual or multilingual staff for lan- guage assistance services provided by the staff for such
p.000267: cli- ents.
p.000267: (5) APPLICATION.—An eligible health center desiring a grant under this subsection shall submit an
p.000267: application to the Secretary at such time, in such manner, and containing such information as the Secretary
p.000267: may reasonably require, includ- ing—
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p.000351: the medicare, medicaid, and State child health insurance programs and to patients who pay privately for
p.000351: services;
p.000351: (C) describes the activities that the applicant and the consortium propose to perform under the grant to
p.000351: further the objectives of this section;
p.000351: (D) demonstrates the consortium’s ability to build on the current system (as of the date of submission of the
p.000351: ap- plication) for serving a community or geographic area of uninsured and underinsured individuals by
p.000351: involving pro- viders who have traditionally provided a significant vol- ume of care for that community;
p.000351: (E) demonstrates the consortium’s ability to develop coordinated systems of care that either directly provide or
p.000351: ensure the prompt provision of a broad range of high-qual- ity, accessible services, including, as appropriate,
p.000351: primary, secondary, and tertiary services, as well as substance abuse treatment and mental health
p.000351: services in a manner that assures continuity of care in the community or geo- graphic area;
p.000351: (F) provides evidence of community involvement in the development, implementation, and direction of the pro- gram
p.000351: that the entity proposes to operate;
p.000351: (G) demonstrates the consortium’s ability to ensure that individuals participating in the program are
p.000351: enrolled in public insurance programs for which the individuals are eligible or know of private insurance
p.000351: programs where available;
p.000351: (H) presents a plan for leveraging other sources of rev- enue, which may include State and local sources and
p.000351: pri- vate grant funds, and integrating current and proposed new funding sources in a way to assure long-term
p.000351: sustain- ability of the program;
p.000351: (I) describes a plan for evaluation of the activities car- ried out under the grant, including measurement
p.000351: of progress toward the goals and objectives of the program and the use of evaluation findings to improve
p.000351: program per- formance;
p.000351: (J) demonstrates fiscal responsibility through the use of appropriate accounting procedures and
p.000351: appropriate management systems;
p.000351: (K) demonstrates the consortium’s commitment to serve the community without regard to the ability of an in-
p.000351: dividual or family to pay by arranging for or providing free or reduced charge care for the poor; and
p.000351: (L) includes such other information as the Secretary may prescribe.
p.000351: (c) LIMITATIONS.—
p.000351: (1) NUMBER OF AWARDS.—
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p.000353: (i) natural disasters or other major disruptions to the security or health of the community or geographic area
p.000353: served by the eligible entity; or
p.000353: (ii) a significant economic deterioration in the community or geographic area served by such
p.000353: eligible entity, that directly and adversely affects the entity receiving an award under subsection (a).
p.000353: (d) PRIORITIES.—In awarding grants under this section, the Secretary—
p.000353: (1) shall accord priority to applicants that demonstrate the extent of unmet need in the community involved for a more
p.000353: co- ordinated system of care; and
p.000353: (2) may accord priority to applicants that best promote the objectives of this section, taking into consideration
p.000353: the extent to which the application involved—
p.000353: (A) identifies a community whose geographical area has a high or increasing percentage of individuals who are
p.000353: uninsured;
p.000353: (B) demonstrates that the applicant has included in its consortium providers, support systems, and programs that have
p.000353: a tradition of serving uninsured individuals and underinsured individuals in the community;
p.000353: (C) shows evidence that the program would expand utilization of preventive and primary care services for un-
p.000353: insured and underinsured individuals and families in the community, including behavioral and mental health
p.000353: serv- ices, oral health services, or substance abuse services;
p.000353: (D) proposes a program that would improve coordina- tion between health care providers and appropriate
p.000353: social service providers;
p.000353: (E) demonstrates collaboration with State and local governments;
p.000353: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000353: Sec. 340 PUBLIC HEALTH SERVICE ACT 354
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p.000353: (F) demonstrates that the applicant makes use of non-
p.000353: Federal contributions to the greatest extent possible; or
p.000353: (G) demonstrates a likelihood that the proposed pro- gram will continue after support under this section ceases.
p.000353: (e) USE OF FUNDS.—
p.000353: (1) USE BY GRANTEES.—
p.000353: (A) IN GENERAL.—Except as provided in paragraphs
p.000353: (2) and (3), a grantee may use amounts provided under this section only for—
p.000353: (i) direct expenses associated with achieving the greater integration of a health care delivery system so that
p.000353: the system either directly provides or ensures the provision of a broad range of culturally competent services,
p.000353: as appropriate, including primary, secondary, and tertiary services, as well as substance abuse treat- ment and mental
p.000353: health services; and
p.000353: (ii) direct patient care and service expansions to fill identified or documented gaps within an integrated
p.000353: delivery system.
p.000353: (B) SPECIFIC USES.—The following are examples of purposes for which a grantee may use grant funds under
p.000353: this section, when such use meets the conditions stated in subparagraph (A):
p.000353: (i) Increases in outreach activities and closing gaps in health care service.
p.000353: (ii) Improvements to case management.
p.000353: (iii) Improvements to coordination of transpor- tation to health care facilities.
p.000353: (iv) Development of provider networks and other innovative models to engage physicians in voluntary efforts
p.000353: to serve the medically underserved within a community.
p.000353: (v) Recruitment, training, and compensation of necessary personnel.
p.000353: (vi) Acquisition of technology for the purpose of co- ordinating care.
p.000353: (vii) Improvements to provider communication, in- cluding implementation of shared information systems or shared
p.000353: clinical systems.
p.000353: (viii) Development of common processes for deter- mining eligibility for the programs provided through the
p.000353: system, including creating common identification cards and single sliding scale discounts.
p.000353: (ix) Development of specific prevention and dis- ease management tools and processes.
p.000353: (x) Translation services.
p.000353: (xi) Carrying out other activities that may be ap- propriate to a community and that would increase ac- cess
p.000353: by the uninsured to health care, such as access initiatives for which private entities provide non-Fed-
...

p.000421: (2) ADDITIONAL FEES.—The Secretary shall require the payment of fees for inspections of laboratories
p.000421: which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate
p.000421: in proficiency testing pro- grams approved under subsection (f)(3)(C).
p.000421: (3) CRITERIA.—
p.000421: (A) FEES UNDER PARAGRAPH (1).—Fees imposed under paragraph (1) shall be sufficient to cover the general costs of
p.000421: administering this section, including evaluating and monitoring proficiency testing programs approved under
p.000421: subsection (f) and accrediting bodies and implementing and monitoring compliance with the requirements of
p.000421: this section.
p.000421: (B) FEES UNDER PARAGRAPH (2).—Fees imposed under paragraph (2) shall be sufficient to cover the cost of
p.000421: the Secretary in carrying out the inspections and proficiency testing described in paragraph (2).
p.000421: (C) FEES IMPOSED UNDER PARAGRAPHS (1) AND (2).— Fees imposed under paragraphs (1) and (2) shall
p.000421: vary by group or classification of laboratory, based on such consid- erations as the Secretary determines are
p.000421: relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.
p.000421: (n) INFORMATION.—On April 1, 1990 and annually thereafter, the Secretary shall compile and make available
p.000421: to physicians and the general public information, based on the previous calendar year, which the Secretary
p.000421: determines is useful in evaluating the performance of a laboratory, including—
p.000421: (1) a list of laboratories which have been convicted under Federal or State laws relating to fraud and
p.000421: abuse, false bil- lings, or kickbacks,
p.000421: (2) a list of laboratories—
p.000421: (A) which have had their certificates revoked, sus- pended, or limited under subsection (i), or
p.000421: (B) which have been the subject of a sanction under subsection (l),
p.000421: together with a statement of the reasons for the revocation, suspension, limitation, or sanction,
p.000421: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000423: PUBLIC HEALTH SERVICE ACT
p.000423: Sec. 354
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p.000423: (3) a list of laboratories subject to intermediate sanctions under subsection (h) together with a
p.000423: statement of the reasons for the sanctions,
p.000423: (4) a list of laboratories whose accreditation has been with- drawn or revoked together with a statement of the reasons
p.000423: for the withdrawal or revocation,
...

p.000435: original action of the Secretary with the return of the addi- tional evidence.
p.000435: (3) JUDGMENT OF COURT.—Upon the filing of the petition referred to in paragraph (1), the court shall
p.000435: have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or
p.000435: permanently. The findings of the Sec- retary as to the facts, if supported by substantial evidence, shall
p.000435: be conclusive.
p.000435: (4) FINALITY OF JUDGMENT.—The judgment of the court af- firming or setting aside, in whole or in part, any action of
p.000435: the Secretary shall be final, subject to review by the Supreme Court of the United States upon
p.000435: certiorari or certification, as provided in section 1254 of title 28, United States Code.
p.000435: (l) INFORMATION.—
p.000435: (1) IN GENERAL.—Not later than October 1, 1996, and an- nually thereafter, the Secretary shall compile and
p.000435: make avail- able to physicians and the general public information that the Secretary determines is useful in
p.000435: evaluating the performance of facilities, including a list of facilities—
p.000435: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000435:
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p.000435: Sec. 354 PUBLIC HEALTH SERVICE ACT 436
p.000435:
p.000435: (A) that have been convicted under Federal or State laws relating to fraud and abuse, false billings,
p.000435: or kick- backs;
p.000435: (B) that have been subject to sanctions under sub- section (h), together with a statement of the
p.000435: reasons for the sanctions;
p.000435: (C) that have had certificates revoked or suspended under subsection (i), together with a statement of the rea-
p.000435: sons for the revocation or suspension;
p.000435: (D) against which the Secretary has taken action under subsection (j), together with a statement of the
p.000435: rea- sons for the action;
p.000435: (E) whose accreditation has been revoked, together with a statement of the reasons of the revocation;
p.000435: (F) against which a State has taken adverse action;
p.000435: and
p.000435: (G) that meets such other measures of performance as
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p.000435: the Secretary may develop.
p.000435: (2) DATE.—The information to be compiled under para- graph (1) shall be information for the calendar
p.000435: year preceding the date the information is to be made available to the public.
p.000435: (3) EXPLANATORY INFORMATION.—The information to be compiled under paragraph (1) shall be accompanied by such
p.000435: ex- planatory information as may be appropriate to assist in the interpretation of the information
p.000435: compiled under such para- graph.
...

p.000469: injuries at sites that are not sub- ject to the Occupational Safety and Health Act of 1970, includ- ing homes,
p.000469: elementary and secondary schools, and public build- ings.
p.000469: SEC. 392A. ø280b–1¿ PREVENTING OVERDOSES OF CONTROLLED SUB- STANCES.
p.000469: (a) EVIDENCE-BASED PREVENTION GRANTS.—
p.000469: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000469: (A) to the extent practicable, carry out and expand any evidence-based prevention activities described in
p.000469: para- graph (2);
p.000469: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000469: out such activity; and
p.000469: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity.
p.000469: (2) EVIDENCE-BASED PREVENTION ACTIVITIES.—An evidence- based prevention activity described in this paragraph is any
p.000469: of the following activities:
p.000469: (A) Improving the efficiency and use of a new or cur- rently operating prescription drug monitoring program,
p.000469: in- cluding by—
p.000469: (i) encouraging all authorized users (as specified by the State or other entity) to register with and
p.000469: use the program;
p.000469: (ii) enabling such users to access any updates to information collected by the program in as close to
p.000469: real-time as possible;
p.000469: (iii) improving the ease of use of such program;
p.000469: (iv) providing for a mechanism for the program to notify authorized users of any potential misuse or abuse of
p.000469: controlled substances and any detection of in- appropriate prescribing or dispensing practices relat- ing to such
p.000469: substances;
p.000469: (v) encouraging the analysis of prescription drug monitoring data for purposes of providing de-identi-
p.000469: fied, aggregate reports based on such analysis to State public health agencies, State substance abuse agen- cies,
p.000469: State licensing boards, and other appropriate
p.000469: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000469:
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p.000471: 471
p.000471: PUBLIC HEALTH SERVICE ACT
p.000471: Sec. 392A
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p.000471: State agencies, as permitted under applicable Federal and State law and the policies of the prescription drug
p.000471: monitoring program and not containing any protected health information, to prevent inappropriate pre-
p.000471: scribing, drug diversion, or abuse and misuse of con- trolled substances, and to facilitate better coordination
p.000471: among agencies;
p.000471: (vi) enhancing interoperability between the pro- gram and any health information technology (includ- ing
p.000471: certified health information technology), including by integrating program data into such technology;
p.000471: (vii) updating program capabilities to respond to technological innovation for purposes of appropriately
p.000471: addressing the occurrence and evolution of controlled substance overdoses;
p.000471: (viii) facilitating and encouraging data exchange between the program and the prescription drug moni- toring
p.000471: programs of other States;
p.000471: (ix) enhancing data collection and quality, includ- ing improving patient matching and proactively moni- toring
p.000471: data quality;
p.000471: (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports
p.000471: for practitioners to review their prescribing patterns in comparison to such patterns of other
p.000471: practitioners in the specialty; and
p.000471: (xi) meeting the purpose of the program estab- lished under section 399O, as described in section
p.000471: 399O(a).
p.000471: (B) Promoting community or health system interven- tions.
p.000471: (C) Evaluating interventions to prevent controlled sub- stance overdoses.
p.000471: (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging
p.000471: public health crises and opportunities to address such cri- ses, such as enhancing public education and awareness on
p.000471: the risks associated with opioids.
p.000471: (3) ADDITIONAL GRANTS.—The Director may award grants to States, localities, and Indian Tribes—
p.000471: (A) to carry out innovative projects for grantees to rap- idly respond to controlled substance misuse, abuse,
p.000471: and overdoses, including changes in patterns of controlled sub- stance use; and
p.000471: (B) for any other evidence-based activity for pre- venting controlled substance misuse, abuse, and
p.000471: overdoses as the Director determines appropriate.
p.000471: (4) RESEARCH.—The Director, in coordination with the As- sistant Secretary for Mental Health and Substance Use
p.000471: and the National Mental Health and Substance Use Policy Labora- tory established under section 501A, as appropriate and
p.000471: appli- cable, may conduct studies and evaluations to address sub- stance use disorders, including
p.000471: preventing substance use dis-
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: Sec. 392A PUBLIC HEALTH SERVICE ACT 472
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p.000471: orders or other related topics the Director determines appro- priate.
p.000471: (b) ENHANCED CONTROLLED SUBSTANCE OVERDOSE DATA COL-
p.000471: LECTION, ANALYSIS, AND DISSEMINATION GRANTS.—
p.000471: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000471: (A) to the extent practicable, carry out any controlled substance overdose data collection activities
p.000471: described in paragraph (2);
p.000471: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000471: out such activity;
p.000471: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and
p.000471: (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to sec- tion
p.000471: 505(d)(1)(A) (relating to the number of individuals ad- mitted to emergency departments as a result of the abuse of
p.000471: alcohol or other drugs).
p.000471: (2) CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION AND ANALYSIS ACTIVITIES.—A controlled substance
p.000471: overdose data collection, analysis, and dissemination activity described in this paragraph is any of the
p.000471: following activities:
p.000471: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal
p.000471: overdoses of controlled substances.
p.000471: (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on
p.000471: such overdoses from appropriate sources such as toxicology re- ports, autopsy reports, death scene
p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
p.000471: coroners, medical examiners, and public health laboratories to im- prove accurate testing and
p.000471: standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of
...

p.000473: effective strategies for preventing such violence.
p.000473: (4) Providing to the public information and education on such violence, including information and education to
p.000473: increase awareness of the public health consequences of such violence.
p.000473: (5) Training health care providers as follows:
p.000473: (A) To identify individuals whose medical conditions or statements indicate that the individuals are victims of
p.000473: such violence.
p.000473: (B) To routinely determine, in examining patients, whether the medical conditions or statements of the
p.000473: pa- tients so indicate.
p.000473: (C) To refer individuals so identified to entities that provide services regarding such violence,
p.000473: including refer- rals for counseling, housing, legal services, and services of community organizations.
p.000473: (6) Making grants to public and nonprofit private entities for demonstration projects with respect to
p.000473: such violence, in- cluding with respect to prevention.
p.000473: (b) For purposes of this part, the term ‘‘interpersonal violence within families and among acquaintances’’
p.000473: includes behavior com- monly referred to as domestic violence, sexual assault, spousal abuse, woman
p.000473: battering, partner abuse, elder abuse, and acquaint- ance rape.
p.000473: SEC. 393A. ø280b–1b¿ USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.
p.000473: (a) PERMITTED USE.—The Secretary, acting through the Na- tional Center for Injury Prevention and Control at the
p.000473: Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape
p.000473: prevention and education programs con- ducted by rape crisis centers, State, territorial or tribal sexual as-
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: Sec. 393A PUBLIC HEALTH SERVICE ACT 474
p.000473: sault coalitions, and other public and private nonprofit entities for—
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p.000473: (1) educational seminars;
p.000473: (2) the operation of hotlines;
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p.000487: (d) DEFINITION.—In this subpart, the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given
p.000487: such terms in sec- tion 4 of the Indian Health Care Improvement Act.
p.000487: (e) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out this subpart, there are authorized
p.000487: to be appropriated
p.000487: $20,000,000 for each of fiscal years 2020 through 2024.
p.000487: Subpart III—Grants for Home Visiting Services for At-Risk Families
p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: serving Native American communities are represented among the grantees.
p.000489: (d) FEDERAL SHARE.—With respect to the costs of carrying out a project under subsection (a), a grant under
p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: of Federal funds; or
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p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
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p.000491: (9) the incidence of developmental disabilities.
p.000491: (n) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under subsection (a) only if—
p.000491: (1) an application for the grant is submitted to the Sec- retary;
p.000491: (2) the application contains the agreements and assur- ances required in this section, and the information
p.000491: required in subsection (j);
p.000491: (3) the application contains evidence that the preparation of the application has been coordinated with the
p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: PUBLIC HEALTH SERVICE ACT
p.000493: Sec. 399
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p.000493: (B) assess the relative effectiveness of projects under subsection (a) in urban and rural areas, and
p.000493: among pro- grams utilizing differing combinations of professionals and trained home visitors recruited from the
p.000493: community to meet the needs of defined target service populations; and
p.000493: (C) make further recommendations necessary or desir- able to increase the effectiveness of such projects.
p.000493: (q) DEFINITIONS.—For purposes of this section:
p.000493: (1) The term ‘‘eligible entity’’ includes public and nonprofit private entities that provide health or related
p.000493: social services, including community-based organizations, visiting nurse orga- nizations, hospitals, local
p.000493: health departments, community health centers, Native Hawaiian health centers, nurse man- aged clinics,
p.000493: family service agencies, child welfare agencies, de- velopmental service providers, family resource and support
p.000493: programs, and resource mothers projects.
p.000493: (2) The term ‘‘eligible family’’ means a family described in subsection (a).
p.000493: (3) The term ‘‘health or developmental complication’’, with respect to a child, means—
p.000493: (A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low
p.000493: birth- weight, and prenatal exposure to maternal substance abuse;
p.000493: (B) a condition arising from a condition described in subparagraph (A);
p.000493: (C) a physical disability or delay; and
p.000493: (D) a developmental disability or delay.
p.000493: (4) The term ‘‘home visiting services’’ means the services specified in subsection (b), provided at the
p.000493: residence of the eli- gible family involved or provided pursuant to arrangements made for the family
p.000493: (including arrangements for services in community settings).
p.000493: (5) The term ‘‘home visitors’’ means providers of home vis- iting services.
p.000493: (r) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000493: to be appropriated
p.000493: $30,000,000 for each of the fiscal years 1993 and 1994.
p.000493: øPart L 94—¿
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p.000493: 94 The content of section 399A above, and the placement of the section in this Act, probably do not
p.000493: reflect the intent of the Congress. Section 399A formerly was section 399D. Section 3106 of Public Law 106–310 (114
p.000493: Stat. 1175) attempts to make various amendments to section 399D, but the amendments cannot be executed because section
p.000493: 399D was redesignated as section 399A by section 502(1) of such Public Law (114 Stat. 1115). (Section 399D
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p.000493: SEC. 399A. ø280d¿ GRANTS FOR SERVICES FOR CHILDREN OF SUB-
p.000493: STANCE ABUSERS. 94
p.000493: (a) ESTABLISHMENT.—
p.000493: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000493: Administra- tion, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000493: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000493: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000493: substance abuser; and
p.000493: (C) to identify such children and such families.
p.000493: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000493: and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted
p.000493: regarding the pro- mulgation of program guidelines and funding priorities under this section.
p.000493: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000493: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000493: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000493: Social Security Act for the State involved—
p.000493: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000493: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000493: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000493: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000493: such payments.
p.000493: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000493: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000493: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000493: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000493: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000493: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
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p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
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p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
p.000495: the State Interagency Coordinating Council, under part C of the Individuals with Disabilities Education Act.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: PUBLIC HEALTH SERVICE ACT
p.000497: Sec. 399A
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p.000497: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000497: applicant involved agrees that the grant will not be expended—
p.000497: (1) to provide inpatient hospital services;
p.000497: (2) to make cash payments to intended recipients of serv- ices;
p.000497: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000497: build- ing or other facility, or purchase major medical equipment;
p.000497: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000497: of Federal funds; or
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p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
p.000497: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant involved
p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
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p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
...

p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000499: providers, and family resource and support pro- grams.
p.000499: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
...

p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
p.000501: the family member involved:
p.000501: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000501: professional, or by a trained worker from the community who is supervised by a profes- sional, or by an
p.000501: entity, where the professional or entity provides assurances that the professional or entity is licensed or certified
p.000501: by the State if required and is complying with applicable licen- sure or certification requirements:
p.000501: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services
p.000501: and services for children of substance abusers.
p.000501: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000501:
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p.000503: 503
p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
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p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: PUBLIC HEALTH SERVICE ACT
p.000505: Sec. 399A
p.000505:
p.000505: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for health,
p.000505: including maternal and child health 95 mental health, child welfare, edu- cation, juvenile justice, developmental
p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
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p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
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p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
p.000507: providers, and family resource and support pro- grams.
p.000507: (5) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.000507: (o) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000507: to be appropriated
p.000507: $50,000,000 for fiscal year 2001, and such sums as may be nec- essary for each of fiscal years 2002 and
p.000507: 2003.
p.000507:
p.000507: PART M—NATIONAL PROGRAM OF CANCER REGISTRIES
p.000507: SEC. 399B. ø280e¿ NATIONAL PROGRAM OF CANCER REGISTRIES.
p.000507: (a) IN GENERAL.—
p.000507: (1) STATEWIDE CANCER REGISTRIES.—The Secretary, acting through the Director of the Centers for Disease
p.000507: Control, may make grants to States, or may make grants or enter into con- tracts with academic or
p.000507: nonprofit organizations designated by the State to operate the State’s cancer registry in lieu of mak- ing a grant
p.000507: directly to the State, to support the operation of population-based, statewide registries to collect, for each
p.000507: condi- tion specified in paragraph (2)(A), data concerning—
p.000507: (A) demographic information about each case of can-
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p.000507: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: maintaining a PDMP, to implement strategies that improve—
p.000535: (1) the reporting of dispensing in the State or locality of a controlled substance to an ultimate user so the
p.000535: reporting oc- curs not later than 24 hours after the dispensing event;
p.000535: (2) the consultation of the PDMP by each prescribing prac- titioner, or their designee, in the State or
p.000535: locality before initi- ating treatment with a controlled substance, or any substance as required by the State
p.000535: to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event;
p.000535: (3) the consultation of the PDMP before dispensing a con- trolled substance, or any substance as required by the State
p.000535: to be reported to the PDMP;
p.000535: (4) the proactive notification to a practitioner when pat- terns indicative of controlled substance misuse by a
p.000535: patient, in- cluding opioid misuse, are detected;
p.000535: (5) the availability of data in the PDMP to other States, as allowable under State law; and
p.000535: (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for
p.000535: surveillance, epidemiology, statistical research, or educational purposes.
p.000535: (c) DRUG MISUSE AND ABUSE.—In consultation with practi- tioners, dispensers, and other relevant and interested
p.000535: stakeholders, a State receiving support under this section—
p.000535: (1) shall establish a program to notify practitioners and dispensers of information that will help to identify
p.000535: and prevent the unlawful diversion or misuse of controlled substances;
p.000535: (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for
p.000535: carrying out drug diversion investigations if the State determines that informa- tion in the PDMP maintained
p.000535: by the State indicates an unlaw- ful diversion or abuse of a controlled substance;
p.000535: (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State
p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: time as practicable, regarding prescription patterns flagged as potentially presenting a risk of misuse, abuse,
p.000535: addiction, over- dose, and other aggregate information, as appropriate and in compliance with applicable
p.000535: Federal and State laws and pro- vided that such reports shall not include protected health in- formation;
p.000535: and
p.000535: (4) may access information about prescriptions, such as claims data, to ensure that such prescribing and
p.000535: dispensing history is updated in as close to real-time as practicable, in compliance with applicable
p.000535: Federal and State laws and pro- vided that such information shall not include protected health information.
p.000535: (d) EVALUATION AND REPORTING.—As a condition on receipt of support under this section, the State shall
p.000535: report on interoper- ability with PDMPs of other States and Federal agencies, where appropriate,
p.000535: intrastate interoperability with health information technology systems such as electronic health records,
p.000535: health infor- mation exchanges, and e-prescribing, where appropriate, and whether or not the State
p.000535: provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a
p.000535: practitioner, where permitted) requests information about such patient.
p.000535: (e) EVALUATION AND REPORTING.—A State receiving support under this section shall provide the Secretary with
p.000535: aggregate non- identifiable information, as permitted by State law, to enable the Secretary—
p.000535: (1) to evaluate the success of the State’s program in achieving the purpose described in subsection
p.000535: (a); or
p.000535: (2) to prepare and submit to the Congress the report re- quired by subsection (i)(2).
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p.000537: PUBLIC HEALTH SERVICE ACT
p.000537: Sec. 399O
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p.000537: confidentiality requirement, including the regulations promul- gated under section 264(c) of the Health Insurance
p.000537: Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 543 of this Act.
p.000537: (4) NO FEDERAL PRIVATE CAUSE OF ACTION.—Nothing in this section shall be construed to create a
p.000537: Federal private cause of action.
p.000537: (i) PROGRESS REPORT.—Not later than 3 years after the date of enactment of this section, the Secretary shall—
p.000537: (1) complete a study that—
p.000537: (A) determines the progress of grantees in establishing and implementing PDMPs consistent with this section;
p.000537: (B) provides an analysis of the extent to which the op- eration of PDMPs has—
p.000537: (i) reduced inappropriate use, abuse, diversion of, and overdose with, controlled substances;
p.000537: (ii) established or strengthened initiatives to en- sure linkages to substance use disorder treatment
p.000537: services; or
p.000537: (iii) affected patient access to appropriate care in States operating PDMPs;
p.000537: (C) determine the progress of grantees in achieving interstate interoperability and intrastate
p.000537: interoperability of PDMPs, including an assessment of technical, legal, and financial barriers to such progress
p.000537: and recommendations for addressing these barriers;
p.000537: (D) determines the progress of grantees in imple- menting near real-time electronic PDMPs;
p.000537: (E) provides an analysis of the privacy protections in place for the information reported to the PDMP
p.000537: in each State or locality receiving support under this section and any recommendations of the Secretary
p.000537: for additional Fed- eral or State requirements for protection of this informa- tion;
p.000537: (F) determines the progress of States or localities in implementing technological alternatives to centralized
p.000537: data storage, such as peer-to-peer file sharing or data pointer systems, in PDMPs and the potential for such
p.000537: alternatives to enhance the privacy and security of individually identifi- able data; and
p.000537: (G) evaluates the penalties that States or localities have enacted for the unauthorized use and disclosure of
p.000537: in- formation maintained in PDMPs, and the criteria used by the Secretary to determine whether such penalties qualify
p.000537: as appropriate for purposes of subsection (a)(2); and
...

p.000539: subsection (a) that—
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p.000539: (i) are designed to train medical, psychology, den- tal, social work, nursing, and other health profession
p.000539: students, interns, residents, fellows, or current health care providers to identify and provide health care serv-
p.000539: ices (including mental or behavioral health care serv- ices and referrals to appropriate community
p.000539: services) to individuals who are or who have been victims of do- mestic violence, dating violence, sexual
p.000539: assault, or stalking; and
p.000539: (ii) plan and develop culturally competent clinical training components for integration into approved in-
p.000539: ternship, residency, and fellowship training or con- tinuing medical or other health education training
p.000539: that address physical, mental, and behavioral health issues, including protective factors, related to domestic
p.000539: violence, dating violence, sexual assault, stalking, and other forms of violence and abuse, focus on reducing
p.000539: health disparities and preventing violence and abuse, and include the primacy of victim safety and confiden-
p.000539: tiality;
p.000539: (B) design and implement comprehensive strategies to improve the response of the health care system to domestic or
p.000539: sexual violence in clinical and public health settings, hospitals, clinics, and other health settings
p.000539: (including be- havioral and mental health), under subsection (a)(3) through—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: (i) the implementation, dissemination, and evalua- tion of policies and procedures to guide health profes-
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p.000539: hiring domestic or sexual assault advocates to provide such services or to model other services
p.000539: appropriate to the geographic and cultural needs of a site;
p.000539: (iii) the development of measures and methods for the evaluation of the practice of identification, inter-
p.000539: vention, and documentation regarding victims of do- mestic violence, dating violence, sexual assault, and
p.000539: stalking, including the development and testing of quality improvement measurements, in accordance
p.000539: with the multi-stakeholder and quality measurement processes established under paragraphs (7) and (8) of
p.000539: section 1890(b) and section 1890A of the Social Secu- rity Act (42 U.S.C. 1395aaa(b)(7) and (8); 42
p.000539: U.S.C. 1890A); and
p.000539: (iv) the provision of training and follow-up tech- nical assistance to health care professionals, and pub- lic
p.000539: health staff, and allied health professionals to iden- tify, assess, treat, and refer clients who are victims of
p.000539: domestic violence, dating violence, sexual assault, or stalking, including using tools and training
p.000539: materials already developed.
p.000539: (2) PERMISSIBLE USES.—
p.000539: (A) CHILD AND ELDER ABUSE.—To the extent consistent with the purpose of this section, a grantee may
p.000539: use amounts received under this section to address, as part of a comprehensive programmatic approach
p.000539: implemented under the grant, issues relating to child or elder abuse.
p.000539: (B) RURAL AREAS.—Grants funded under paragraphs
p.000539: (1) and (2) of subsection (a) may be used to offer to rural areas community-based training
p.000539: opportunities, which may include the use of distance learning networks and other available technologies
p.000539: needed to reach isolated rural areas, for medical, nursing, and other health profession students and residents on
p.000539: domestic violence, dating violence, sexual assault, stalking, and, as appropriate, other forms of vio- lence
p.000539: and abuse.
p.000539: (C) OTHER USES.—Grants funded under subsection (a)(3) may be used for—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: PUBLIC HEALTH SERVICE ACT
p.000541: Sec. 399P
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p.000541: (i) the development of training modules and poli- cies that address the overlap of child abuse, domestic
p.000541: violence, dating violence, sexual assault, and stalking and elder abuse, as well as childhood exposure to
p.000541: do- mestic and sexual violence;
p.000541: (ii) the development, expansion, and implementa- tion of sexual assault forensic medical examination or sexual
p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
p.000541: dress issues of confidentiality and patient safety and com- ply with applicable confidentiality and nondisclosure
p.000541: re- quirements under section 40002(b)(2) of the Violence Against Women Act of 1994 and the Family Violence
p.000541: Pre- vention and Services Act, and that faculty and staff associ- ated with delivering educational components
p.000541: are fully trained in procedures that will protect the immediate and ongoing security and confidentiality
p.000541: of the patients, pa- tient records, and staff. Such grantees shall consult enti- ties with demonstrated
p.000541: expertise in the confidentiality and safety needs of victims of domestic violence, dating vio- lence, sexual
p.000541: assault, and stalking on the development and adequacy of confidentially and security procedures, and provide
p.000541: documentation of such consultation.
p.000541: (B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.— Grantees under this section shall provide to patients
p.000541: ad- vance notice about any circumstances under which infor- mation may be disclosed, such as mandatory
p.000541: reporting laws, and shall give patients the option to receive informa- tion and referrals without affirmatively
p.000541: disclosing abuse.
p.000541: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee shall use not more than 10 percent of the amounts
p.000541: received under a grant under this section for administrative expenses.
p.000541: (3) APPLICATION.—
p.000541: (A) PREFERENCE.—In selecting grant recipients under this section, the Secretary shall give preference to
p.000541: appli- cants based on the strength of their evaluation strategies, with priority given to outcome based evaluations.
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: (B) SUBSECTION (A)(1) AND (2) GRANTEES.—Applications for grants under paragraphs (1) and (2) of subsection
p.000541: (a) shall include—
p.000541: (i) documentation that the applicant represents a team of entities working collaboratively to strengthen
p.000541: the response of the health care system to domestic vio- lence, dating violence, sexual assault, or stalking, and which
p.000541: includes at least one of each of—
p.000541: (I) an accredited school of allopathic or osteo- pathic medicine, psychology, nursing, dentistry, social
p.000541: work, or other health field;
p.000541: (II) a health care facility or system; or
p.000541: (III) a government or nonprofit entity with a history of effective work in the fields of domestic
p.000541: violence, dating violence, sexual assault, or stalk- ing; and
p.000541: (ii) strategies for the dissemination and sharing of curricula and other educational materials developed under
p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
p.000541: nonprofit victim advocacy organizations, State or trib- al law enforcement task forces (where appropriate), and
p.000541: population specific organizations with dem- onstrated expertise in domestic violence, dating vio-
p.000541: lence, sexual assault, or stalking;
p.000541: (iv) with respect to an application for a grant under which the grantee will have contact with pa-
p.000541: tients, a plan, developed in collaboration with local victim service providers, to respond appropriately
p.000541: to and make correct referrals for individuals who disclose that they are victims of domestic violence, dating
p.000541: vio- lence, sexual assault, stalking, or other types of vio- lence, and documentation provided by the
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p.000543: January 30, 2020
p.000543: (v) with respect to an application for a grant pro- posing to fund a program described in
p.000543: subsection (b)(2)(C)(ii), a certification that any sexual assault fo- rensic medical examination and sexual
p.000543: assault nurse examiner programs supported with such grant funds will adhere to the guidelines set forth by the
p.000543: Attorney General.
p.000543: (d) ELIGIBLE ENTITIES.—
p.000543: (1) IN GENERAL.—To be eligible to receive funding under paragraph (1) or (2) of subsection (a), an entity shall
p.000543: be—
p.000543: (A) a nonprofit organization with a history of effective work in the field of training health professionals
p.000543: with an understanding of, and clinical skills pertinent to, domestic violence, dating violence, sexual assault,
p.000543: or stalking, and lifetime exposure to violence and abuse;
p.000543: (B) an accredited school of allopathic or osteopathic medicine, psychology, nursing, dentistry, social work, or
p.000543: al- lied health;
p.000543: (C) a health care provider membership or professional organization, or a health care system; or
p.000543: (D) a State, tribal, territorial, or local entity.
p.000543: (2) SUBSECTION (A)(3) GRANTEES.—To be eligible to receive funding under subsection (a)(3), an entity shall be—
p.000543: (A) a State department (or other division) of health, a State, tribal, or territorial domestic violence or
p.000543: sexual as- sault coalition or victim service provider, or any other non- profit, nongovernmental organization with
p.000543: a history of ef- fective work in the fields of domestic violence, dating vio- lence, sexual assault, or
p.000543: stalking, and health care, includ- ing physical or mental health care; or
p.000543: (B) a local victim service provider, a local department (or other division) of health, a local health clinic,
p.000543: hospital, or health system, or any other community-based organiza- tion with a history of effective work in the field
p.000543: of domestic violence, dating violence, sexual assault, or stalking and health care, including physical or mental
p.000543: health care.
p.000543: (e) TECHNICAL ASSISTANCE.—
p.000543: (1) IN GENERAL.—Of the funds made available to carry out this section for any fiscal year, the Secretary may make
...

p.000555: (2) COMMUNITY SETTING.—The term ‘‘community setting’’ means a home or a community organization located in
p.000555: the neighborhood in which a participant in the program under this section resides.
p.000555: (3) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private entity (including a
p.000555: State or public subdivision of a State, a public health department, a free health clinic, a hospital, or
p.000555: a Federally-qualified health center (as defined in section 1861(aa) of the Social Security Act)), or a
p.000555: consortium of any such entities.
p.000555: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ means a community
p.000555: iden- tified by a State—
p.000555: (A) that has a substantial number of individuals who are members of a medically underserved population, as de-
p.000555: fined by section 330(b)(3); and
p.000555: (B) a significant portion of which is a health profes- sional shortage area as designated under section 332.
p.000555: SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
p.000555: (a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
p.000555: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Agency for Healthcare Research and Quality,
p.000555: shall establish a Primary Care Extension Program.
p.000555: (2) PURPOSE.—The Primary Care Extension Program shall provide support and assistance to primary care providers
p.000555: to educate providers about preventive medicine, health pro- motion, chronic disease management, mental
p.000555: and behavioral health services (including substance abuse prevention and treatment services), and
p.000555: evidence-based and evidence-informed therapies and techniques, in order to enable providers to incor- porate such
p.000555: matters into their practice and to improve commu- nity health by working with community-based health connec-
p.000555: tors (referred to in this section as ‘‘Health Extension Agents’’).
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000555:
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p.000557: PUBLIC HEALTH SERVICE ACT
p.000557: Sec. 399V–1
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p.000557: January 30, 2020
p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
...

p.000559: for the implementation of a Hub, for a period of 6 years; or
p.000559: (B) planning grants, that are awarded to State or multistate entities with the goal of developing a
p.000559: plan for a Hub, for a period of 2 years.
p.000559: (2) APPLICATIONS.—To be eligible for a grant under sub- section (b), a State or multistate entity shall submit
p.000559: to the Sec- retary an application, at such time, in such manner, and con- taining such information as the
p.000559: Secretary may require.
p.000559: (3) EVALUATION.—A State that receives a grant under sub- section (b) shall be evaluated at the end of the grant period
p.000559: by an evaluation panel appointed by the Secretary.
p.000559: (4) CONTINUING SUPPORT.—After the sixth year in which assistance is provided to a State under a grant awarded
p.000559: under subsection (b), the State may receive additional support under this section if the State program has received
p.000559: satisfactory eval- uations with respect to program performance and the merits of the State sustainability plan, as
p.000559: determined by the Secretary.
p.000559: (5) LIMITATION.—A State shall not use in excess of 10 per- cent of the amount received under a grant to carry out
p.000559: admin- istrative activities under this section. Funds awarded pursuant to this section shall not be used for funding
p.000559: direct patient care.
p.000559: (e) REQUIREMENTS ON THE SECRETARY.—In carrying out this section, the Secretary shall consult with the heads
p.000559: of other Federal agencies with demonstrated experience and expertise in health care and preventive medicine, such
p.000559: as the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Adminis- tration, the
p.000559: Health Resources and Services Administration, the Na- tional Institutes of Health, the Office of the National
p.000559: Coordinator for Health Information Technology, the Indian Health Service, the Agricultural Cooperative Extension
p.000559: Service of the Department of Agriculture, and other entities, as the Secretary determines appro- priate.
p.000559: (f) AUTHORIZATION OF APPROPRIATIONS.—To awards grants as provided in subsection (d), there are authorized to be
p.000559: appropriated
p.000559: $120,000,000 for each of fiscal years 2011 and 2012, and such sums as may be necessary to carry out this
p.000559: section for each of fiscal years 2013 through 2014.
p.000559: SEC. 399V–2. ø280g–13¿ NATIONAL CONGENITAL HEART DISEASE RE- SEARCH, SURVEILLANCE, AND AWARENESS.
p.000559: (a) IN GENERAL.—The Secretary shall, as appropriate—
p.000559: (1) enhance and expand research and data collection ef- forts related to congenital heart disease, including to
p.000559: study and track the epidemiology of congenital heart disease to under- stand health outcomes for
p.000559: individuals with congenital heart disease across all ages;
p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000559:
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p.000597: Sec. 401 PUBLIC HEALTH SERVICE ACT 598
p.000597:
p.000597: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out sub- sections (a), (b), (c)(1), and (d), there are
p.000597: authorized to be appro- priated $4,900,000 for each of fiscal years 2015 through 2019.
p.000597: TITLE IV—NATIONAL RESEARCH INSTITUTES PART A—NATIONAL INSTITUTES OF HEALTH
p.000597: SEC. 401. ø281¿ ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
p.000597: (a) RELATION TO PUBLIC HEALTH SERVICE.—The National Insti- tutes of Health is an agency of the Service. 1
p.000597: (b) NATIONAL RESEARCH INSTITUTES AND NATIONAL CENTERS.— The following agencies of the National Institutes of
p.000597: Health are na- tional research institutes or national centers:
p.000597: (1) The National Cancer Institute.
p.000597: (2) The National Heart, Lung, and Blood Institute.
p.000597: (3) The National Institute of Diabetes and Digestive and Kidney Diseases.
p.000597: (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
p.000597: (9) The National Eye Institute.
p.000597: (10) The National Institute of Neurological Disorders and Stroke.
p.000597: (11) The National Institute on Deafness and Other Com- munication Disorders.
p.000597: (12) The National Institute on Alcohol Abuse and Alco- holism.
p.000597: (13) The National Institute on Drug Abuse.
p.000597: (14) The National Institute of Mental Health.
p.000597: (15) The National Institute of General Medical Sciences.
p.000597: (16) The National Institute of Environmental Health Sciences.
p.000597: (17) The National Institute of Nursing Research.
p.000597: (18) The National Institute of Biomedical Imaging and Bio- engineering.
p.000597: (19) The National Human Genome Research Institute.
p.000597: (20) The National Library of Medicine.
p.000597: (21) The National Center for Advancing Translational Sciences.
p.000597: (22) The John E. Fogarty International Center for Ad- vanced Study in the Health Sciences.
p.000597:
p.000597:
p.000597:
p.000597:
p.000597:
p.000597:
p.000597:
p.000597: January 30, 2020
p.000597: 1 See footnote for section 202.
p.000597: 2 Section 212 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000597: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–359)
p.000597: amended subparagraph (H) to read as provided above, there- by indicating the intent of the Congress to change the
p.000597: designation of the Institute. (The former designation was the National Institute of Dental Research.) Conforming
p.000597: changes were not, how- ever, made to section 453 or the related subpart heading, or to the reference in section
p.000597: 409A(a).
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000597:
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p.000599: PUBLIC HEALTH SERVICE ACT
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p.000635: the objectives are expected to be achieved, and justifications for revisions to the plan.
p.000635: (c) ADDITIONAL REPORTS.—In addition to reports required by subsections (a) and (b), the Director of NIH
p.000635: or the head of a na- tional research institute or national center may submit to the Con- gress such additional
p.000635: reports as the Director or the head of such institute or center determines to be appropriate.
p.000635: SEC. 403A. ø283a¿ ANNUAL REPORTING TO INCREASE INTERAGENCY COLLABORATION AND COORDINATION.
p.000635: (a) COLLABORATION WITH OTHER HHS AGENCIES.—On an an- nual basis, the Director of NIH shall submit to the
p.000635: Secretary a re- port on the activities of the National Institutes of Health involving collaboration with other agencies
p.000635: of the Department of Health and Human Services.
p.000635: (b) CLINICAL TRIALS.—Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a
p.000635: report that identifies each clinical trial that is registered during such calendar year in the databank of
p.000635: information established under section 402(i).
p.000635: (c) HUMAN TISSUE SAMPLES.—On an annual basis, the Director of NIH shall submit to the Congress a report
p.000635: that describes how the National Institutes of Health and its agencies store and track human tissue samples.
p.000635: (d) FIRST REPORT.—The first report under subsections (a), (b), and (c) shall be submitted not later than
p.000635: 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006.
p.000635: SEC. 403B. ø283a–1¿ ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.
p.000635: (a) WHISTLEBLOWER COMPLAINTS.—
p.000635: (1) IN GENERAL.—On an annual basis, the Director of NIH shall submit to the Inspector General of the Department
p.000635: of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on
p.000635: Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the
p.000635: Committee on Appro- priations of the Senate a report summarizing the activities of the National Institutes
p.000635: of Health relating to whistleblower complaints.
p.000635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000635:
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p.000637: PUBLIC HEALTH SERVICE ACT
p.000637: Sec. 403D
p.000637:
p.000637: (2) CONTENTS.—For each whistleblower complaint pending during the year for which a report is submitted under this sub-
p.000637: section, the report shall identify the following:
p.000637: (A) Each agency of the National Institutes of Health involved.
p.000637: (B) The status of the complaint.
p.000637: (C) The resolution of the complaint to date.
p.000637: (b) FIRST REPORT.—The first report under subsection (a) shall be submitted not later than 1 year after the date
p.000637: of the enactment of the National Institutes of Health Reform Act of 2006.
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p.000745: Sec. 464H
p.000745:
p.000745: (b) The Coordinating Committee shall, with respect to deafness and other communication disorders—
p.000745: (1) provide for the coordination of the activities of the na- tional research institutes; and
p.000745: (2) coordinate the aspects of all Federal health programs and activities relating to deafness and other
p.000745: communication disorders in order to assure the adequacy and technical sound- ness of such programs and activities and
p.000745: in order to provide for the full communication and exchange of information necessary to maintain adequate coordination
p.000745: of such programs and activi- ties.
p.000745: (c) The Coordinating Committee shall be composed of the direc- tors of each of the national research institutes
p.000745: and divisions in- volved in research with respect to deafness and other communica- tion disorders and
p.000745: representatives of all other Federal departments and agencies whose programs involve health functions or
p.000745: respon- sibilities relevant to deafness and other communication disorders.
p.000745: (d) The Coordinating Committee shall be chaired by the Direc- tor of NIH (or the designee of the Director).
p.000745: The Committee shall meet at the call of the chair, but not less often than four times a year.
p.000745: LIMITATION ON ADMINISTRATIVE EXPENSES
p.000745: SEC. 464F. ø285m–6¿ With respect to amounts appropriated for a fiscal year for the National Institutes of
p.000745: Health, the limitation established in section 408(a)(1) on the expenditure of such amounts for administrative expenses
p.000745: shall apply to administrative expenses of the National Institute on Deafness and Other Communication Disorders.
p.000745: Subpart 14—National Institute on Alcohol Abuse and Alcoholism
p.000745:
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p.000745: PURPOSE OF INSTITUTE
p.000745: SEC. 464H. ø285n¿ (a) IN GENERAL.—The general purpose of the National Institute on Alcohol Abuse and
p.000745: Alcoholism (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of
p.000745: biomedical and behavioral research, health services re- search, research training, and health information
p.000745: dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism.
p.000745: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000745: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of alcohol
p.000745: abuse and alcoholism. In carrying out the program, the Director of the Institute is author- ized to—
p.000745: (1) collect and disseminate through publications and other appropriate means (including the development of
p.000745: curriculum materials), information as to, and the practical application of, the research and other activities
p.000745: under the program;
p.000745: (2) make available research facilities of the Public Health Service to appropriate public authorities, and to
p.000745: health officials and scientists engaged in special study;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000745:
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p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
p.000745:
p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
p.000745: (6) conduct an intramural program of biomedical, behav- ioral, epidemiological, and social research,
p.000745: including research into the most effective means of treatment and service deliv- ery, and including
p.000745: research involving human subjects, which is—
p.000745: (A) located in an institution capable of providing all necessary medical care for such human subjects,
p.000745: including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and
p.000745: intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is
p.000745: determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
p.000745:
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p.000745: (B) associated with an accredited medical or research training institution;
p.000745: (7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health
p.000745: Service, persons not otherwise eligible for such treatment;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000747: PUBLIC HEALTH SERVICE ACT
p.000747: Sec. 464J
p.000747:
p.000747: (8) provide to health officials, scientists, and appropriate public and other nonprofit institutions and
p.000747: organizations, tech- nical advice and assistance on the application of statistical and other scientific research
p.000747: methods to experiments, studies, and surveys in health and medical fields;
p.000747: (9) enter into contracts under this title without regard to sections 3648 and 3709 of the Revised
p.000747: Statutes (31 U.S.C. 529; 39 41 U.S.C. 5); and
p.000747: (10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and Alcoholism, such
p.000747: additional means as he deems necessary or appropriate to carry out the purposes of this section.
p.000747: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000747: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000747: Institute and in disseminating the results of such research to health professionals and the general public.
p.000747: ASSOCIATE DIRECTOR FOR PREVENTION
p.000747: SEC. 464I. ø285n–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000747: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000747: concerning the prevention of alcohol abuse and al- coholism. The Associate Director shall be appointed by the Director
p.000747: of the Institute from individuals who because of their professional training or expertise are experts in
p.000747: alcohol abuse and alcoholism or the prevention of such.
p.000747: (b) BIENNIAL REPORT.—The Associate Director for Prevention shall prepare for inclusion in the biennial
p.000747: report made under sec- tion 407 a description of the prevention activities of the Institute, including a
p.000747: description of the staff and resources allocated to those activities.
p.000747: NATIONAL ALCOHOL RESEARCH CENTER
p.000747: SEC. 464J. ø285n–2¿ (a) The Secretary acting through the In- stitute may designate National Alcohol
p.000747: Research Centers for the purpose of interdisciplinary research relating to alcoholism and other biomedical,
p.000747: behavioral, and social issues related to alcoholism and alcohol abuse. No entity may be designated as a Center unless
p.000747: an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be
p.000747: submitted in such man- ner and contain such information as the Secretary may reasonably require. The Secretary may
p.000747: not approve such an application un- less—
p.000747: (1) the application contains or is supported by reasonable assurances that—
p.000747: (A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social,
p.000747: and re- lated disciplines, long-term research on alcoholism and other alcohol problems and to provide
p.000747: coordination of such research among such disciplines;
p.000747:
p.000747:
p.000747:
p.000747: January 30, 2020
p.000747: 39 Now codified to section 3324 of title 31, United States Code.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000747: Sec. 464L PUBLIC HEALTH SERVICE ACT 748
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p.000747: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000747: facili- ties) to carry out the research plan contained in the appli- cation,
p.000747: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000747: alco- holism and other alcohol problems;
p.000747: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000747: alco- holism and other alcohol problems;
p.000747: (E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol
p.000747: problems for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other
p.000747: specialized grad- uate students; and
p.000747: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000747: social service fields as the Secretary may require. 40
p.000747: (2) the application contains a detailed five-year plan for re- search relating to alcoholism and other alcohol
p.000747: problems.
p.000747: (b) The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to
p.000747: Centers which have been designated under this section. No funds provided under a grant under this subsection may be
p.000747: used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For
p.000747: the purposes of the preceding sentence, the term ‘‘con- struction’’ has the meaning given that term by section
p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000747: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of drug
p.000747: abuse. In carrying out the program, the Director of the Institute shall give special consider- ation to
p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
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p.000747: January 30, 2020
p.000747: 40 So in law. See section 16(a)(5) of Public Law 96–180 (93 Stat. 1305). The period probably should be
p.000747: ‘‘; and’’. (Section 464J formerly was section 504 of another law. The amendment made by Public Law 96–180 was directed
p.000747: to section 504 of that other law, which was Public Law 91– 616.)
p.000747: 41 So in law. See section 2(a) of Public Law 102–352 (106 Stat. 938). Section 701(1) does not provide
p.000747: a definition for the term ‘‘construction’’, but former section 701(1) did provide such a definition.
p.000747: Public Law 102–408 amended title VII generally; definitions for the title are now pro- vided in section 799, and that
p.000747: section does not define the term ‘‘construction’’.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000749: 749
p.000749: PUBLIC HEALTH SERVICE ACT
p.000749: Sec. 464N
p.000749:
p.000749: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Substance Abuse and Mental Health
p.000749: Services Ad- ministration in focusing the services research activities of the Insti- tute and in disseminating the
p.000749: results of such research to health professionals and the general public.
p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
p.000749: SEC. 464M. ø285o–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000749: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000749: concerning the prevention of drug abuse. The Asso- ciate Director shall be appointed by the Director of the
p.000749: Institute from individuals who because of their professional training or ex- pertise are experts in drug abuse
p.000749: and the prevention of such abuse.
p.000749: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000749: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000749: and resources allocated to those activities.
p.000749:
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p.000749: January 30, 2020
p.000749:
p.000749: DRUG ABUSE RESEARCH CENTERS
p.000749: SEC. 464N. ø285o–2¿ (a) AUTHORITY.—The Director of the In- stitute may designate National Drug Abuse
p.000749: Research Centers for the purpose of interdisciplinary research relating to drug abuse and other biomedical,
p.000749: behavioral, and social issues related to drug abuse. No entity may be designated as a Center unless an applica-
p.000749: tion therefore has been submitted to, and approved by, the Sec- retary. Such an application shall be
p.000749: submitted in such manner and contain such information as the Secretary may reasonably require. The Secretary may not
p.000749: approve such an application unless—
p.000749: (1) the application contains or is supported by reasonable assurances that—
p.000749: (A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social,
p.000749: and re- lated disciplines, long-term research on drug abuse and to provide coordination of such research among
p.000749: such dis- ciplines;
p.000749: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000749: facili- ties) to carry out the research plan contained in the appli- cation;
p.000749: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000749: drug abuse;
p.000749: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000749: drug abuse;
p.000749: (E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse
p.000749: for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other specialized
p.000749: grad- uate students; and
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000749:
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p.000749: Sec. 464N PUBLIC HEALTH SERVICE ACT 750
p.000749:
p.000749: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000749: social service fields as the Secretary may require. 42
p.000749: (2) the application contains a detailed five-year plan for re- search relating to drug abuse.
p.000749: (b) GRANTS.—The Director of the Institute shall, under such conditions as the Secretary may reasonably
p.000749: require, make annual grants to Centers which have been designated under this section. No funds provided
p.000749: under a grant under this subsection may be used for the purchase of any land or the purchase,
p.000749: construction, preservation, or repair of any building. For the purposes of the pre- ceding sentence, the term
p.000749: ‘‘construction’’ has the meaning given that term by section 701(1). 43
p.000749: (c) DRUG ABUSE AND ADDITION 44 RESEARCH.—
p.000749: (1) GRANTS OR COOPERATIVE AGREEMENTS.—The Director of the Institute may make grants or enter into cooperative agree-
p.000749: ments to expand the current and ongoing interdisciplinary re- search and clinical trials with treatment
p.000749: centers of the Na- tional Drug Abuse Treatment Clinical Trials Network relating to drug abuse and addiction,
p.000749: including related biomedical, be- havioral, and social issues.
p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
p.000749: for drug abuse and addiction may be used for research and clinical trials relating to—
p.000749: (A) the effects of drug abuse on the human body, in- cluding the brain;
p.000749: (B) the addictive nature of drugs and how such effects differ with respect to different individuals;
p.000749: (C) the connection between drug abuse and mental health;
p.000749: (D) the identification and evaluation of the most effec- tive methods of prevention of drug abuse and addiction;
p.000749: (E) the identification and development of the most ef- fective methods of treatment of drug addiction,
p.000749: including pharmacological treatments;
p.000749: (F) risk factors for drug abuse;
p.000749: (G) effects of drug abuse and addiction on pregnant women and their fetuses; and
p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
p.000749:
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p.000749: January 30, 2020
p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000751: 751
p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000751: with respect to AIDS research related to—
p.000751: (1) primary prevention of the spread of HIV, including transmission via drug abuse;
p.000751: (2) drug abuse services research; and
p.000751: (3) other matters determined appropriate by the Director.
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p.000751: January 30, 2020
p.000751:
p.000751: MEDICATION DEVELOPMENT PROGRAM
p.000751: SEC. 464P. ø285o–4¿ (a) ESTABLISHMENT.—There is established in the Institute a Medication Development Program
p.000751: through which the Director of such Institute shall—
p.000751: (1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate
p.000751: the ap- proval process of drug abuse treatments;
p.000751: (2) encourage and promote (through grants, contracts, international collaboration, or otherwise)
p.000751: expanded research programs, investigations, experiments, community trials, and studies, into the development
p.000751: and use of medications to treat drug addiction;
p.000751: (3) establish or provide for the establishment of research facilities;
p.000751: (4) report on the activities of other relevant agencies relat- ing to the development and use of
p.000751: pharmacotherapeutic treat- ments for drug addiction;
p.000751: (5) collect, analyze, and disseminate data useful in the de- velopment and use of pharmacotherapeutic treatments for
p.000751: drug addiction and collect, catalog, analyze, and disseminate through international channels, the
p.000751: results of such research;
p.000751: ctly or through grants, contracts, or cooperative agree- ments, support training in the fundamental
p.000751: sciences and clin- ical disciplines related to the pharmacotherapeutic treatment of drug abuse, including
p.000751: the use of training stipends, fellow- ships, and awards where appropriate; and
p.000751: (7) coordinate the activities conducted under this section with related activities conducted within the National
p.000751: Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate
p.000751: institutes and shall con- sult with the Directors of such Institutes.
p.000751: (b) DUTIES.—In carrying out the activities described in sub- section (a), the Director of the Institute—
p.000751: (1) shall collect and disseminate through publications and other appropriate means, information pertaining
p.000751: to the re- search and other activities under this section;
p.000751: (2) shall make grants to or enter into contracts and cooper- ative agreements with individuals and public and private
p.000751: enti- ties to further the goals of the program;
p.000751: (3) may, in accordance with section 496, and in consulta- tion with the National Advisory Council on
p.000751: Drug Abuse, ac- quire, construct, improve, repair, operate, and maintain pharmacotherapeutic research
p.000751: centers, laboratories, and other
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000751: Sec. 464R PUBLIC HEALTH SERVICE ACT 752
p.000751:
p.000751: necessary facilities and equipment, and such other real or per- sonal property as the Director determines necessary,
p.000751: and may, in consultation with such Advisory Council, make grants for the construction or renovation of
p.000751: facilities to carry out the pur- poses of this section;
p.000751: (4) may accept voluntary and uncompensated services;
p.000751: (5) may accept gifts, or donations of services, money, or property, real, personal, or mixed, tangible
p.000751: or intangible; and
p.000751: (6) shall take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge
p.000751: and information are maintained between the Institute and the other scientific, medical, and biomedical
p.000751: disciplines and organi- zations nationally and internationally.
p.000751: (c) REPORT.—
p.000751: (1) IN GENERAL.—Not later than December 31, 1992, and each December 31 thereafter, the Director of the
p.000751: Institute shall submit to the Office of National Drug Control Policy estab- lished under section 1002 of
p.000751: the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1501) a report, in accordance with paragraph (3), that
p.000751: describes the objectives and activities of the program as- sisted under this section.
p.000751: (2) NATIONAL DRUG CONTROL STRATEGY.—The Director of National Drug Control Policy shall incorporate, by
p.000751: reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy
p.000751: submitted the following Feb- ruary 1 under section 1005 of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1504).
p.000751: (d) DEFINITION.—For purposes of this section, the term ‘‘pharmacotherapeutics’’ means medications used to
p.000751: treat the symp- toms and disease of drug abuse, including medications to—
p.000751: (1) block the effects of abused drugs;
p.000751: (2) reduce the craving for abused drugs;
p.000751: (3) moderate or eliminate withdrawal symptoms;
p.000751: (4) block or reverse the toxic effect of abused drugs; or
p.000751: (5) prevent relapse in persons who have been detoxified from drugs of abuse.
p.000751: Subpart 16—National Institute of Mental Health
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p.000751: January 30, 2020
p.000751:
p.000751: PURPOSE OF INSTITUTE
p.000751: SEC. 464R. ø285p¿ (a) IN GENERAL.—The general purpose of the National Institute of Mental Health
p.000751: (hereafter in this subpart referred to as the ‘‘Institute’’) is the conduct and support of bio- medical
p.000751: and behavioral research, health services research, research training, and health information dissemination with respect
p.000751: to the cause, diagnosis, treatment, control and prevention of mental ill- ness.
p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000753: 753
p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
p.000753: (C) study the effects of discrimination on institutions and individuals, including majority institutions
p.000753: and indi- viduals;
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p.000759: amendment made by section 10334(c)(1)(D)(iii) of Public Law 111–148.
p.000759: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000759: Sec. 464z–3 PUBLIC HEALTH SERVICE ACT 760
p.000759:
p.000759: (b) PRIORITIES.—The Director of the Institute shall in expend- ing amounts appropriated under this subpart
p.000759: give priority to con- ducting and supporting minority health disparities research.
p.000759: (c) MINORITY HEALTH DISPARITIES RESEARCH.—For purposes of this subpart:
p.000759: (1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral research on minority health
p.000759: con- ditions (as defined in paragraph (2)), including research to pre- vent, diagnose, and treat such conditions.
p.000759: (2) The term ‘‘minority health conditions’’, with respect to individuals who are members of minority
p.000759: groups, means all diseases, disorders, and conditions (including with respect to mental health and substance
p.000759: abuse)—
p.000759: (A) unique to, more serious, or more prevalent in such individuals;
p.000759: (B) for which the factors of medical risk or types of medical intervention may be different for such
p.000759: individuals, or for which it is unknown whether such factors or types are different for such individuals; or
p.000759: (C) with respect to which there has been insufficient research involving such individuals as subjects or
p.000759: insuffi- cient data on such individuals.
p.000759: (3) The term ‘‘minority group’’ has the meaning given the term ‘‘racial and ethnic minority group’’ in section
p.000759: 1707.
p.000759: (4) The terms ‘‘minority’’ and ‘‘minorities’’ refer to individ- uals from a minority group.
p.000759: (d) HEALTH DISPARITY POPULATIONS.—For purposes of this subpart:
p.000759:
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p.000759: January 30, 2020
p.000759: (1) A population is a health disparity population if, as de- termined by the Director of the Institute after
p.000759: consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant
p.000759: disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the
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p.000789: President and the Congress under section 403.
p.000789: PART G—AWARDS AND TRAINING
p.000789: RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS 51
p.000789: SEC. 487. ø288¿ (a)(1) The Secretary shall—
p.000789: (A) provide Ruth L. Kirschstein National Research Service Awards 52 for—
p.000789: (i) biomedical and behavioral research at the National Institutes of Health in matters relating to the cause, diag-
p.000789: nosis, prevention, and treatment of the diseases or other health problems to which the activities of the
p.000789: National In- stitutes of Health and Administration 53 are directed;
p.000789: (ii) training at the National Institutes of Health and at the Administration 53 of individuals to
p.000789: undertake such research;
p.000789: (iii) biomedical and behavioral research and health services research (including research in primary
p.000789: medical care) at public and nonprofit private entities; and
p.000789:
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p.000789: January 30, 2020
p.000789: 51 The typeface is so in law. See section 804(b) of Public Law 107–206 (116 Stat. 874).
p.000789: 52 Section 804(c) of Public Law 107–206 (116 Stat. 874) provides as follows:
p.000789: ‘‘(c) Any reference in any law (other than this Act), regulation, document, record, map, or other paper
p.000789: of the United States to ‘National Research Service Awards’ shall be considered to be a reference to ‘Ruth
p.000789: L. Kirschstein National Research Service Awards’ ’’.
p.000789: 53 So in law. Section 163(b)(4)(B) of Public Law 102–321 (106 Stat. 376) struck a reference in paragraph
p.000789: (1) to the former Alcohol, Drug Abuse, and Mental Health Administration, but failed to conform related
p.000789: references.
p.000789: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000789: Sec. 487 PUBLIC HEALTH SERVICE ACT 790
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p.000789:
p.000789: (iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake
p.000789: bio- medical and behavioral research;
p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
p.000789: (C) provide contracts for scholarships and loan repayments in accordance with sections 487D and 487E, subject
...

p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
p.000807: part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental
p.000807: health be used collaboratively, as appropriate, and in consultation with the Agency for Health Care
p.000807: Policy Re- search.
p.000807:
p.000807:
p.000807:
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p.000807:
p.000807: January 30, 2020
p.000807: ANIMALS IN RESEARCH
p.000807: SEC. 495. ø289d¿ (a) The Secretary, acting through the Direc- tor of NIH, shall establish guidelines for the
p.000807: following:
p.000807: (1) The proper care of animals to be used in biomedical and behavioral research.
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000807:
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p.000809: 809
p.000809: PUBLIC HEALTH SERVICE ACT
p.000809: Sec. 495
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p.000809: January 30, 2020
p.000809: (2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall
p.000809: require—
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p.000823: Health, as the Director of the National Institutes of Health determines is appropriate.
p.000823: (2) SUPPORT SERVICES.—The Director of the National Insti- tutes of Health may provide facilities, utilities and
p.000823: support services to the Foundation if it is determined by the Director to be advantageous to the
p.000823: research programs of the National Institutes of Health.
p.000823: (l) FUNDING.—From amounts appropriated to the National In- stitutes of Health, for each fiscal year, the
p.000823: Director of NIH shall transfer not less than $500,000 and not more than $1,250,000 to the Foundation.
p.000823: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000823:
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p.000825: 825
p.000825: PUBLIC HEALTH SERVICE ACT
p.000825: Sec. 501
p.000825:
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p.000825: January 30, 2020
p.000825: TITLE V—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
p.000825: PART A—ORGANIZATION AND GENERAL AUTHORITIES
p.000825: SEC. 501. ø290aa¿ SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
p.000825: (a) ESTABLISHMENT.—The Substance Abuse and Mental Health Services Administration (hereafter referred to in this
p.000825: title as the ‘‘Administration’’) is an agency of the Service.
p.000825: (b) CENTERS.—The following Centers are agencies of the Ad- ministration:
p.000825: (1) The Center for Substance Abuse Treatment.
p.000825: (2) The Center for Substance Abuse Prevention.
p.000825: (3) The Center for Mental Health Services.
p.000825: (c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SEC-
p.000825: RETARY.—
p.000825: (1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant
p.000825: Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘‘Assistant
p.000825: Secretary’’) who shall be ap- pointed by the President, by and with the advice and consent of the Senate.
p.000825: (2) DEPUTY ASSISTANT SECRETARY.—The Assistant Sec- retary, with the approval of the Secretary, may appoint
p.000825: a Dep- uty Assistant Secretary and may employ and prescribe the functions of such officers and employees,
p.000825: including attorneys, as are necessary to administer the activities to be carried out through the
p.000825: Administration.
p.000825: (d) AUTHORITIES.—The Secretary, acting through the Assistant Secretary, shall—
p.000825: (1) supervise the functions of the Centers of the Adminis- tration in order to assure that the
p.000825: programs carried out through each such Center receive appropriate and equitable support and that there is
p.000825: cooperation among the Centers in the implementation of such programs;
p.000825: (2) establish and implement, through the respective Cen- ters, a comprehensive program to improve the
p.000825: provision of treatment and related services to individuals with respect to substance use disorders and mental
...

p.000825: (6) in cooperation with the National Institutes of Health, the Centers for Disease Control and
p.000825: Prevention, and the Health Resources and Services Administration, develop edu- cational materials and
p.000825: intervention strategies to reduce the risks of HIV, hepatitis, tuberculosis, and other communicable diseases
p.000825: among individuals with mental or substance use dis- orders, and to develop appropriate mental health
p.000825: services for individuals with such diseases or disorders;
p.000825: (7) coordinate Federal policy with respect to the provision of treatment services for substance use
p.000825: disorders, including services that utilize drugs or devices approved or cleared by the Food and Drug
p.000825: Administration for the treatment of sub- stance use disorders;
p.000825: (8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of
p.000825: Health and the Agency for Healthcare Research and Quality, as appro- priate, to evaluate the process, outcomes
p.000825: and community im- pact of prevention and treatment services and systems of care in order to identify the manner
p.000825: in which such services can most effectively be provided;
p.000825: (9) collaborate with the Director of the National Institutes of Health in the development and maintenance of a system
p.000825: by which the relevant research findings of the National Institute on Drug Abuse, the National Institute
p.000825: on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency
p.000825: for Healthcare Research and Quality are disseminated to service providers in a manner designed to improve the
p.000825: delivery and effectiveness of prevention, treat- ment, and recovery support services and are appropriately
p.000825: in- corporated into programs carried out by the Administration;
p.000825: (10) encourage public and private entities that provide health insurance to provide benefits for substance use
p.000825: disorder and mental health services;
p.000825: (11) work with relevant agencies of the Department of Health and Human Services on integrating mental health
p.000825: pro- motion and substance use disorder prevention with general health promotion and disease prevention and
p.000825: integrating men- tal and substance use disorders treatment services with phys- ical health treatment services;
p.000825: (12) monitor compliance by hospitals and other facilities with the requirements of sections 542 and 543;
p.000825: (13) with respect to grant programs authorized under this title or part B of title XIX, or grant programs otherwise
p.000825: funded by the Administration—
p.000825: (A) require that all grants that are awarded for the provision of services are subject to performance
p.000825: and out- come evaluations;
p.000825: (B) ensure that the director of each Center of the Ad- ministration consistently documents the application of cri-
p.000825: teria when awarding grants and the ongoing oversight of grantees after such grants are awarded;
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p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
p.000827: illness, particularly adults with a serious mental illness, children with a serious emotional disturbance, and the
p.000827: family members of such adults and children, with respect to improving commu- nity-based and other mental
p.000827: health services;
p.000827: (20) collaborate with the Secretary of Defense and the Sec- retary of Veterans Affairs to improve the provision
p.000827: of mental and substance use disorder services provided by the Depart- ment of Defense and the Department
p.000827: of Veterans Affairs to members of the Armed Forces, veterans, and the family mem- bers of such members and veterans,
p.000827: including through the pro- vision of services using the telehealth capabilities of the De- partment of
p.000827: Defense and the Department of Veterans Affairs;
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000827:
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p.000827: (A) the capacity of the grantee to implement the award;
p.000827: (B) requirements for the description of the program implementation approach;
p.000827: (C) the extent to which the grant plan submitted by the grantee as part of its application must explain how
p.000827: the grantee will reach the population of focus and provide a statement of need, which may include information
p.000827: on how the grantee will increase access to services and a descrip- tion of measurable objectives for improving
p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
p.000827: evaluating service pro- grams for the prevention and treatment of alcoholism and alco- hol abuse within the
p.000827: Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center for Mental Health
p.000827: Services, and coordinating such programs among the Centers, and among the Centers and other public
p.000827: and private entities. The Associate Administrator also may en- sure that alcohol prevention, education, and
p.000827: policy strategies are integrated into all programs of the Centers that address substance abuse prevention,
p.000827: education, and policy, and that the Center for Substance Abuse Prevention addresses the Healthy
p.000827: People 2010 goals and the National Dietary Guide-
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: 829
p.000829: PUBLIC HEALTH SERVICE ACT
p.000829: Sec. 501
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p.000829: January 30, 2020
p.000829: lines of the Department of Health and Human Services and the Department of Agriculture related to alcohol
p.000829: consumption.
p.000829: (2) PLAN.—
p.000829: (A) The Assistant Secretary, acting through the Asso- ciate Administrator for Alcohol Prevention and
p.000829: Treatment Policy, shall develop, and periodically review and as appro- priate revise, a plan for programs and policies
p.000829: to treat and prevent alcoholism and alcohol abuse. The plan shall be developed (and reviewed and revised) in
p.000829: collaboration with the Directors of the Centers of the Administration and in consultation with members of
p.000829: other Federal agencies and public and private entities.
p.000829: (B) Not later than 1 year after the date of the enact- ment of the ADAMHA Reorganization Act, the
p.000829: Assistant Secretary shall submit to the Congress the first plan devel- oped under subparagraph (A).
p.000829: (3) REPORT.—
p.000829: (A) Not less than once during each 2 years, the Assist- ant Secretary, acting through the Associate Administrator for
p.000829: Alcohol Prevention and Treatment Policy, shall prepare a report describing the alcoholism and alcohol abuse
p.000829: pre- vention and treatment programs undertaken by the Ad- ministration and its agencies, and the report shall
p.000829: include a detailed statement of the expenditures made for the ac- tivities reported on and the personnel
p.000829: used in connection with such activities.
p.000829: (B) Each report under subparagraph (A) shall include a description of any revisions in the plan under paragraph
p.000829: (2) made during the preceding 2 years.
p.000829: (C) Each report under subparagraph (A) shall be sub- mitted to the Assistant Secretary for inclusion in the bien- nial
p.000829: report under subsection (m).
p.000829: (f) ASSOCIATE ADMINISTRATOR FOR WOMEN’S SERVICES.—
p.000829: (1) APPOINTMENT.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint an Associate
p.000829: Adminis- trator for Women’s Services who shall report directly to the As- sistant Secretary.
p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
p.000829: ferred to in paragraph (3)), and report biannually to the Assistant Secretary regarding the extent to which
p.000829: women are represented among senior personnel, and make recommendations regarding improvement in the participation
p.000829: of women in the workforce of the Admin- istration; and
p.000829: (iii) prepare, for inclusion in the biennial report required pursuant to subsection (m), a description of
p.000829: activities of the Committee, including findings made by the Committee regarding—
p.000829: (I) the extent of expenditures made for wom- en’s substance abuse and mental health services by the
p.000829: agencies of the Administration; and
p.000829: (II) the estimated level of funding needed for substance abuse and mental health services to meet the
p.000829: needs of women;
p.000829: (D) improve the collection of data on women’s health by—
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p.000829: January 30, 2020
p.000829: (i) reviewing the current data at the Administra- tion to determine its uniformity and applicability;
p.000829: (ii) developing standards for all programs funded by the Administration so that data are, to the extent
p.000829: practicable, collected and reported using common re- porting formats, linkages and definitions; and
p.000829: (iii) reporting to the Assistant Secretary a plan for incorporating the standards developed under clause
p.000829: (ii) in all Administration programs and a plan to as- sure that the data so collected are accessible to health
p.000829: professionals, providers, researchers, and members of the public; and
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: (E) shall establish, maintain, and operate a program to provide information on women’s substance abuse
p.000831: and mental health services.
p.000831: (3) STUDY.—
p.000831: (A) The Secretary, acting through the Assistant Sec- retary for Personnel, shall conduct a study to evaluate the
p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000831:
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p.000835: into programs;
p.000835: (B) the recruitment, training, and retention of a men- tal and substance use disorders workforce;
p.000835: (C) the integration of mental disorder services, sub- stance use disorder services, and physical health
p.000835: services;
p.000835: (D) homelessness; and
p.000835: (E) veterans;
p.000835: (5) a description of the manner in which the Administra- tion promotes coordination by grantees under
p.000835: this title, and part B of title XIX, with State or local agencies; and
p.000835: (6) a description of the activities carried out under section 501A(e), with respect to mental and substance use
p.000835: disorders, including—
p.000835: (A) the number and a description of grants awarded;
p.000835: (B) the total amount of funding for grants awarded;
p.000835: (C) a description of the activities supported through such grants, including outcomes of programs
p.000835: supported; and
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p.000835: (D) information on how the National Mental Health and Substance Use Policy Laboratory is consulting with
p.000835: the Assistant Secretary for Planning and Evaluation and collaborating with the Center for Substance Abuse
p.000835: Treat- ment, the Center for Substance Abuse Prevention, the Center for Behavioral Health Statistics and
p.000835: Quality, and the Center for Mental Health Services to carry out such activities; and
p.000835: (7) recommendations made by the Assistant Secretary for Planning and Evaluation under section 6021 of the
p.000835: Helping Families in Mental Health Crisis Reform Act of 2016 to im- prove programs within the
p.000835: Administration, and actions taken in response to such recommendations to improve programs within the
p.000835: Administration.
p.000835: The Assistant Secretary may meet reporting requirements estab- lished under this title by providing the contents
p.000835: of such reports as an addendum to the biennial report established under this sub- section, notwithstanding
p.000835: the timeline of other reporting require- ments in this title. Nothing in this subsection shall be
p.000835: construed to alter the content requirements of such reports or authorize the Assistant Secretary to alter
p.000835: the timeline of any such reports to be less frequent than biennially, unless as specified in this title.
p.000835: (n) APPLICATIONS FOR GRANTS AND CONTRACTS.—With respect to awards of grants, cooperative agreements, and
p.000835: contracts under this title, the Assistant Secretary, or the Director of the Center in- volved, as the case may be, may
p.000835: not make such an award unless—
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: Sec. 501A PUBLIC HEALTH SERVICE ACT 836
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p.000835:
p.000835: (1) an application for the award is submitted to the official involved;
p.000835: (2) with respect to carrying out the purpose for which the award is to be provided, the application provides
p.000835: assurances of compliance satisfactory to such official; and
p.000835: (3) the application is otherwise in such form, is made in such manner, and contains such agreements,
p.000835: assurances, and information as the official determines to be necessary to carry out the purpose for which the award is
p.000835: to be provided.
p.000835: (o) EMERGENCY RESPONSE.—
p.000835: (1) IN GENERAL.—Notwithstanding section 504 and except as provided in paragraph (2), the Secretary may use not to
p.000835: ex- ceed 2.5 percent of all amounts appropriated under this title for a fiscal year to make
p.000835: noncompetitive grants, contracts or cooperative agreements to public entities to enable such enti- ties to
p.000835: address emergency substance abuse or mental health needs in local communities.
p.000835: (2) EXCEPTIONS.—Amounts appropriated under part C shall not be subject to paragraph (1).
p.000835: (3) EMERGENCIES.—The Secretary shall establish criteria for determining that a substance abuse or mental health
p.000835: emer- gency exists and publish such criteria in the Federal Register prior to providing funds under this
p.000835: subsection.
p.000835: (4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the
p.000835: end of the fiscal year following the fiscal year for which such amounts are appropriated.
p.000835: (p) LIMITATION ON THE USE OF CERTAIN INFORMATION.—No in- formation, if an establishment or person supplying the
p.000835: information or described in it is identifiable, obtained in the course of activities undertaken or supported under
p.000835: section 505 may be used for any purpose other than the purpose for which it was supplied unless such
p.000835: establishment or person has consented (as determined under regulations of the Secretary) to its use for such
p.000835: other purpose. Such information may not be published or released in other form if the person who supplied
p.000835: the information or who is described in it is identifiable unless such person has consented (as determined under
p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
p.000835: SEC. 501A. ø290aa–0¿ NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
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p.000837: disorder services;
p.000837: (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information
p.000837: from grant- ees under programs operated by the Administration in order to evaluate and disseminate information on
p.000837: evidence-based prac- tices, including culturally and linguistically appropriate serv- ices, as appropriate, and
p.000837: service delivery models;
p.000837: (4) provide leadership in identifying and coordinating poli- cies and programs, including evidence-based programs,
p.000837: related to mental and substance use disorders;
p.000837: (5) periodically review programs and activities operated by the Administration relating to the diagnosis or
p.000837: prevention of, treatment for, and recovery from, mental and substance use disorders to—
p.000837: (A) identify any such programs or activities that are duplicative;
p.000837: (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
p.000837: (C) formulate recommendations for coordinating, elimi- nating, or improving programs or activities
p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
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p.000837: (1) IN GENERAL.—In carrying out subsection (b)(3), the Laboratory—
p.000837: (A) may give preference to models that improve—
p.000837: (i) the coordination between mental health and physical health providers;
p.000837: (ii) the coordination among such providers and the justice and corrections system; and
p.000837: (iii) the cost effectiveness, quality, effectiveness, and efficiency of health care services furnished
p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
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p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
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p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
p.000837: appropriate, consult with the Chief Medical Officer, appointed under section 501(g), the advisory councils described
p.000837: in section 502, the National In- stitute of Mental Health, the National Institute on Drug
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000839: PUBLIC HEALTH SERVICE ACT
p.000839: Sec. 502
p.000839:
p.000839: Abuse, and the National Institute on Alcohol Abuse and Alco- holism, as appropriate.
p.000839: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated—
p.000839: (A) to carry out paragraph (1)(A), $7,000,000 for the period of fiscal years 2018 through 2020; and
p.000839: (B) to carry out paragraph (1)(B), $7,000,000 for the period of fiscal years 2018 through 2020.
p.000839: ADVISORY COUNCILS
p.000839: SEC. 502. ø290aa–1¿ (a) APPOINTMENT.—
p.000839: (1) IN GENERAL.—The Secretary shall appoint an advisory council for—
p.000839: (A) the Substance Abuse and Mental Health Services Administration;
p.000839: (B) the Center for Substance Abuse Treatment;
p.000839: (C) the Center for Substance Abuse Prevention; and
p.000839: (D) the Center for Mental Health Services.
p.000839: Each such advisory council shall advise, consult with, and make recommendations to the Secretary and the
p.000839: Assistant Sec- retary or Director of the Administration or Center for which the advisory council is
p.000839: established concerning matters relating to the activities carried out by and through the Administration or Center and
p.000839: the policies respecting such activities.
p.000839: (2) FUNCTION AND ACTIVITIES.—An advisory council—
p.000839: (A)(i) may on the basis of the materials provided by the organization respecting activities conducted at
p.000839: the or- ganization, make recommendations to the Assistant Sec- retary or Director of the Administration or
p.000839: Center for which it was established respecting such activities;
p.000839: (ii) shall review applications submitted for grants and cooperative agreements for activities for which advisory
p.000839: council approval is required under section 504(d)(2) and recommend for approval applications for projects that
p.000839: show promise of making valuable contributions to the Adminis- tration’s mission; and
p.000839: (iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the or-
p.000839: ganization;
p.000839: (B) may collect, by correspondence or by personal in- vestigation, information as to studies and services that
p.000839: are being carried on in the United States or any other country as to the diseases, disorders, or other aspects
p.000839: of human health with respect to which the organization was estab- lished and with the approval of the
p.000839: Assistant Secretary or Director, whichever is appropriate, make such information available through appropriate
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p.000839:
p.000839: Sec. 502 PUBLIC HEALTH SERVICE ACT 840
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p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
p.000839: members to be appointed by the Secretary under paragraph (3).
p.000839: (2) EX OFFICIO MEMBERS.—The ex officio members of an advisory council shall consist of—
p.000839: (A) the Secretary;
p.000839: (B) the Assistant Secretary;
p.000839: (C) the Director of the Center for which the council is established;
p.000839: (D) the Under Secretary for Health of the Department of Veterans Affairs;
p.000839: (E) the Assistant Secretary for Defense for Health Af- fairs (or the designates of such officers);
p.000839: (F) the Chief Medical Officer, appointed under section 501(g);
p.000839: (G) the Director of the National Institute of Mental Health for the advisory councils appointed
p.000839: under sub- sections (a)(1)(A) and (a)(1)(D);
p.000839: (H) the Director of the National Institute on Drug Abuse for the advisory councils appointed under
p.000839: sub- sections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.000839: (I) the Director of the National Institute on Alcohol Abuse and Alcoholism for the advisory councils
p.000839: appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and
p.000839: (J) such additional officers or employees of the United States as the Secretary determines necessary for the advi- sory
p.000839: council to effectively carry out its functions.
p.000839: (3) APPOINTED MEMBERS.—Individuals shall be appointed to an advisory council under paragraph (1) as follows:
p.000839: (A) Nine of the members shall be appointed by the Secretary from among the leading representatives of
p.000839: the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
p.000839: the Admin- istration or Center for which the advisory council is estab- lished.
p.000839: (B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders
p.000839: in fields of public policy, public relations, law, health policy economics, or management.
p.000839: (C) Not less than half of the members of the advisory council appointed under subsection (a)(1)(D)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree in psychology; or
p.000839: (III) have an advanced degree in nursing or social work from an accredited graduate school or be a certified
p.000839: physician assistant; and
p.000839: (ii) shall specialize in the mental health field.
p.000839: (D) Not less than half of the members of the advisory councils appointed under subsections (a)(1)(B) and
p.000839: (a)(1)(C)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree; or
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000839:
p.000839:
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p.000841: or Center for which the advisory council is established to serve as the Executive Secretary of the
p.000841: advisory council. The Assistant Secretary or Director shall make available to the advisory council such staff,
p.000841: information, and other assistance
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000841: as it may require to carry out its functions. The Assistant Sec- retary or Director shall provide
p.000841: orientation and training for new members of the advisory council to provide for their effective par-
p.000841: ticipation in the functions of the advisory council.
p.000841: REPORTS ON ALCOHOLISM, ALCOHOL ABUSE, AND DRUG ABUSE
p.000841: SEC. 503. ø290aa–2¿ (a) The Secretary shall submit to Con- gress on or before January 15, 1984, and
p.000841: every three years there- after a report—
p.000841: (1) containing current information on the health con- sequences of using alcoholic beverages,
p.000841: (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: (b) The Secretary shall submit to Congress on or before Janu- ary 15, 1984, and every three years thereafter
p.000841: a report—
p.000841: (1) describing the health consequences and extent of drug abuse in the United States;
p.000841: (2) describing current research findings made with respect to drug abuse, including current findings on the health
p.000841: effects of marihuana and the addictive property of tobacco; and
p.000841: (3) containing such recommendations for legislation and administrative action as the Secretary may deem
p.000841: appropriate.
p.000841: SEC. 503A. ø290aa–2a¿ REPORT ON INDIVIDUALS WITH CO-OCCURRING MENTAL ILLNESS AND SUBSTANCE ABUSE DISORDERS.
p.000841: (a) IN GENERAL.—Not later than 2 years after the date of the enactment of this section, the Secretary
p.000841: shall, after consultation with organizations representing States, mental health and sub- stance abuse
p.000841: treatment providers, prevention specialists, individ- uals receiving treatment services, and family members of such
p.000841: indi- viduals, prepare and submit to the Committee on Health, Edu- cation, Labor, and Pensions of the
p.000841: Senate and the Committee on Commerce of the House of Representatives, a report on prevention and treatment services
p.000841: for individuals who have co-occurring men- tal illness and substance abuse disorders.
p.000841: (b) REPORT CONTENT.—The report under subsection (a) shall be based on data collected from existing Federal and State
p.000841: surveys re- garding the treatment of co-occurring mental illness and substance abuse disorders and shall include—
p.000841: (1) a summary of the manner in which individuals with co- occurring disorders are receiving treatment, including the
p.000841: most up-to-date information available regarding the number of chil- dren and adults with co-occurring mental illness
p.000841: and substance abuse disorders and the manner in which funds provided under sections 1911 and 1921 are
p.000841: being utilized, including the number of such children and adults served with such funds;
p.000841: (2) a summary of improvements necessary to ensure that individuals with co-occurring mental illness
p.000841: and substance abuse disorders receive the services they need;
p.000841: (3) a summary of practices for preventing substance abuse among individuals who have a mental illness and are
p.000841: at risk of having or acquiring a substance abuse disorder; and
p.000841: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000841:
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p.000841:
p.000843: 843
p.000843: PUBLIC HEALTH SERVICE ACT
p.000843: Sec. 505
p.000843:
p.000843: (4) a summary of evidenced-based practices for treating in- dividuals with co-occurring mental illness and substance
p.000843: abuse disorders and recommendations for implementing such prac- tices.
p.000843: (c) FUNDS FOR REPORT.—The Secretary may obligate funds to carry out this section with such appropriations as
p.000843: are available.
p.000843: SEC. 504. 1 ø290aa–3¿ PEER REVIEW.
p.000843: (a) IN GENERAL.—The Secretary, after consultation with the Assistant Secretary, shall require
p.000843: appropriate peer review of grants, cooperative agreements, and contracts to be administered through the
p.000843: agency which exceed the simple acquisition threshold as defined in section 4(11) of the Office of Federal
p.000843: Procurement Pol- icy Act.
p.000843: (b) MEMBERS.—The members of any peer review group estab- lished under subsection (a) shall be individuals
p.000843: who by virtue of their training or experience are eminently qualified to perform the review functions of the
p.000843: group. Not more than one-fourth of the members of any such peer review group shall be officers or employ- ees of
p.000843: the United States. In the case of any such peer review group that is reviewing a grant, cooperative agreement,
p.000843: or contract re- lated to mental illness treatment, not less than half of the mem- bers of such peer
p.000843: review group shall be licensed and experienced professionals in the prevention, diagnosis, or treatment of, or
p.000843: recov- ery from, mental illness or co-occurring mental illness and sub- stance use disorders and have a
p.000843: medical degree, a doctoral degree in psychology, or an advanced degree in nursing or social work from an
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p.000843: Health Statistics
p.000843:
p.000843: 1 Section 504 appears according to the probable intent of the Congress. Section 3401(b) of Pub- lic Law 106–310 (114
p.000843: Stat. 1218) provides that the section ‘‘is amended as follows:’’. No amend- atory instructions were then given, but a
p.000843: substitute text was provided. The amendment probably should have instructed that section 504 ‘‘is amended to read as
p.000843: follows:’’.
p.000843: 2 Section 502 of Public Law 104–237 (110 Stat. 3112) provides as follows:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: Continued
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
p.000843:
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p.000843: Sec. 505 PUBLIC HEALTH SERVICE ACT 844
p.000843:
p.000843: and Quality (in this section referred to as the ‘‘Center’’). The Cen- ter shall be headed by a Director (in
p.000843: this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive
p.000843: experience and academic qualifications in research and analysis in behavioral health care or related fields. (b)
p.000843: The Director shall—
p.000843: (1) coordinate the Administration’s integrated data strategy, including by collecting data each year on——
p.000843: (A) the national incidence and prevalence of the var- ious forms of mental illness and substance abuse; and
p.000843: (B) the incidence and prevalence of such various forms in major metropolitan areas selected by the Director. 3
p.000843: (2) provide statistical and analytical support for activities of the Administration;
p.000843: (3) recommend a core set of performance metrics to evalu- ate activities supported by the Administration; and
p.000843: (4) coordinate with the Assistant Secretary, the Assistant Secretary for Planning and Evaluation, and the
p.000843: Chief Medical Officer appointed under section 501(g), as appropriate, to im- prove the quality of services
p.000843: provided by programs of the Ad- ministration and the evaluation of activities carried out by the Administration.
p.000843: (c) MENTAL HEALTH.—With respect to the activities of the Di- rector under subsection (b)(1) relating to mental
p.000843: health, the Direc- tor shall ensure that such activities include, at a minimum, the col- lection of data on—
p.000843: (1) the number and variety of public and nonprofit private treatment programs;
p.000843: (2) the number and demographic characteristics of individ- uals receiving treatment through such programs;
p.000843: (3) the type of care received by such individuals; and
p.000843: (4) such other data as may be appropriate.
p.000843: (d) SUBSTANCE ABUSE.—
p.000843: (1) IN GENERAL.—With respect to the activities of the Di- rector under subsection (b)(1) relating to
p.000843: substance abuse, the Director shall ensure that such activities include, at a min- imum, the collection of
p.000843: data on—
p.000843: (A) the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of
p.000843: alcohol or other drugs;
p.000843: (B) the number of deaths occurring as a result of substance abuse, as indicated in reports by coroners in coordination
p.000843: with the Centers for Disease Control and Prevention;
p.000843: (C) the number and variety of public and private nonprofit treatment programs, including the number and type of patient
p.000843: slots available;
p.000843: (D) the number of individuals seeking treatment through such programs, the number and demographic
p.000843: characteristics of individuals receiving such treatment, the percentage of individ-
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: ‘‘The Secretary of Health and Human Services shall develop a public health monitoring pro- gram to monitor
p.000843: methamphetamine abuse in the United States. The program shall include the collection and dissemination of data
p.000843: related to methamphetamine abuse which can be used by public health officials in policy development.’’.
p.000843: 3 So in law. The period at the end of subparagraph (B) probably should be a semicolon.
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
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p.000845: 845
p.000845: PUBLIC HEALTH SERVICE ACT
p.000845: Sec. 506
p.000845:
p.000845: uals who complete such programs, and, with respect to individ- uals receiving such treatment, the length of time
p.000845: between an individual’s request for treatment and the commencement of treatment;
p.000845: (E) the number of such individuals who return for treat- ment after the completion of a prior treatment
p.000845: in such pro- grams and the method of treatment utilized during the prior treatment;
p.000845: (F) the number of individuals receiving public assistance for such treatment programs;
p.000845: (G) the costs of the different types of treatment modalities for drug and alcohol abuse and the aggregate
p.000845: relative costs of each such treatment modality provided within a State in each fiscal year;
p.000845: (H) to the extent of available information, the number of individuals receiving treatment for alcohol or
p.000845: drug abuse who have private insurance coverage for the costs of such treat- ment;
p.000845: (I) the extent of alcohol and drug abuse among high school students and among the general population; and
p.000845: (J) the number of alcohol and drug abuse counselors and other substance abuse treatment personnel employed in
p.000845: public and private treatment facilities.
p.000845: (2) ANNUAL SURVEYS; PUBLIC AVAILABILITY OF DATA.—Annual survey 4s shall be carried out in the
p.000845: collection of data under this subsection. Summaries and analyses of the data collected shall be made
p.000845: available to the public.
p.000845: (e) CONSULTATION.—After consultation with the States and with appropriate national organizations, the
p.000845: Assistant Secretary shall use existing standards and best practices to develop uniform criteria for the
p.000845: collection of data, using the best available tech- nology, pursuant to this section.
p.000845: SEC. 506. ø290aa–5¿ GRANTS FOR THE BENEFIT OF HOMELESS INDIVID- UALS.
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts and cooperative agreements to community-based public
p.000845: and private nonprofit entities for the purposes of providing mental health and substance use disorder
p.000845: services for homeless individuals. In car- rying out this section, the Secretary shall consult with the
p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
p.000845: (b) PREFERENCES.—In awarding grants, contracts, and coopera- tive agreements under subsection (a), the Secretary
p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
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p.000847: 847
p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
p.000847: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000847: submit, in the ap- plication for such grant, a plan for the evaluation of any project un- dertaken with funds provided
p.000847: under this section. Such entity shall provide the Secretary with periodic evaluations of the progress of such
p.000847: project and such evaluation at the completion of such project as the Secretary determines to be appropriate.
p.000847: The final evaluation submitted by such entity shall include a recommendation as to whether such project shall
p.000847: continue.
p.000847: (f) REPORT.—Not later than 3 years after the date of the enact- ment of this section and annually thereafter,
p.000847: the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of
p.000847: the Senate, a report describing the services provided pursuant to this section.
p.000847: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000847: $15,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 and 2003.
p.000847: PART B—CENTERS AND PROGRAMS
p.000847: Subpart 1—Center for Substance Abuse Treatment
p.000847: CENTER FOR SUBSTANCE ABUSE TREATMENT 6
p.000847: SEC. 507. ø290bb¿ (a) ESTABLISHMENT.—There is established in the Administration a Center for Substance
p.000847: Abuse Treatment (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000847: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000847: individ- uals with extensive experience or academic qualifications in the treatment of substance use
p.000847: disorders or in the evaluation of sub- stance use disorder treatment systems.
p.000847: (b) DUTIES.—The Director of the Center shall—
p.000847: (1) administer the substance use disorder treatment block grant program authorized in section 1921;
p.000847: (2) ensure that emphasis is placed on children and adoles- cents in the development of treatment programs;
p.000847: (3) collaborate with the Attorney General to develop pro- grams to provide substance use disorder
p.000847: treatment services to individuals who have had contact with the Justice system, es- pecially adolescents;
p.000847: (4) collaborate with the Director of the Center for Sub- stance Abuse Prevention in order to provide
p.000847: outreach services to identify individuals in need of treatment services, with em-
p.000847:
p.000847:
p.000847:
p.000847:
p.000847:
p.000847:
p.000847: January 30, 2020
p.000847: 6 Section 4 of Public Law 108–358 (118 Stat. 1664) authorizes the Secretary of Health and Human Services
p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000847:
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: January 30, 2020
p.000847:
p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
p.000847: (5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the
p.000847: National Institute on Alcohol Abuse and Alcoholism, and with the States to promote the study, dissemination, and
p.000847: implementation of research find- ings that will improve the delivery and effectiveness of treat- ment
p.000847: services;
p.000847: (6) collaborate with the Administrator of the Health Re- sources and Services Administration and the
p.000847: Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into
p.000847: the mainstream of the health care system of the United States of programs for providing treat- ment
p.000847: services;
p.000847: (7) evaluate plans submitted by the States pursuant to sec- tion 1932(a)(6) in order to determine whether the
p.000847: plans ade- quately provide for the availability, allocation, and effective- ness of treatment services;
p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
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p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000847:
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
...

p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
p.000849: in therapy or in other necessary health and rehabilitative activi- ties.
p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000849:
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
p.000849:
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p.000849: January 30, 2020
p.000849:
p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
...

p.000853: of the Senate, a report describing pro- grams carried out pursuant to this section (other than subsection
p.000853: (r)). Every 2 years thereafter, the Director shall prepare a report describing such programs carried out
p.000853: during the preceding 2 years, and shall submit the report to the Assistant Secretary for inclusion in the biennial
p.000853: report under section 501(m). Each report under this subsection shall include a summary of any evaluations
p.000853: conducted under subsection (m) during the period with respect to which the report is prepared.
p.000853: (q) DEFINITIONS.—For purposes of this section:
p.000853: (1) The term ‘‘authorized services’’ means treatment serv- ices and supplemental services.
p.000853: (2) The term ‘‘eligible woman’’ means a woman who has been admitted to a program operated pursuant to
p.000853: subsection (a).
p.000853:
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p.000853: January 30, 2020
p.000853: (3) The term ‘‘funding agreement’’, with respect to an award under subsection (a), means that the Director may
p.000853: make the award only if the applicant makes the agreement involved.
p.000853: (4) The term ‘‘treatment services’’ means treatment for a substance use disorder, including the counseling
p.000853: and services described in subsection (c)(2).
p.000853: (5) The term ‘‘supplemental services’’ means the services described in subsection (d).
p.000853: (r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.—
p.000853: (1) IN GENERAL.—From amounts made available under subsection (s), the Director of the Center for
p.000853: Substance Abuse Treatment shall carry out a pilot program under which com- petitive grants are made by
p.000853: the Director to State substance abuse agencies—
p.000853: (A) to enhance flexibility in the use of funds designed to support family-based services for
p.000853: pregnant and postpartum women with a primary diagnosis of a sub- stance use disorder, including opioid use
p.000853: disorders;
p.000853: (B) to help State substance abuse agencies address identified gaps in services furnished to such women
p.000853: along
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000853:
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p.000853: Sec. 508 PUBLIC HEALTH SERVICE ACT 854
p.000853:
p.000853: the continuum of care, including services provided to women in nonresidential-based settings; and
p.000853: (C) to promote a coordinated, effective, and efficient State system managed by State substance abuse
p.000853: agencies by encouraging new approaches and models of service de- livery.
p.000853: (2) REQUIREMENTS.—In carrying out the pilot program under this subsection, the Director shall—
p.000853: (A) require State substance abuse agencies to submit to the Director applications, in such form and manner and
p.000853: containing such information as specified by the Director, to be eligible to receive a grant under the program;
p.000853: (B) identify, based on such submitted applications, State substance abuse agencies that are eligible for
p.000853: such grants;
p.000853: (C) require services proposed to be furnished through such a grant to support family-based treatment and
p.000853: other services for pregnant and postpartum women with a pri- mary diagnosis of a substance use
p.000853: disorder, including opioid use disorders;
p.000853: (D) not require that services furnished through such a grant be provided solely to women that reside in facilities;
p.000853: (E) not require that grant recipients under the pro- gram make available through use of the grant all the serv-
p.000853: ices described in subsection (d); and
p.000853: (F) consider not applying the requirements described in paragraphs (1) and (2) of subsection (f) to an applicant,
p.000853: depending on the circumstances of the applicant.
p.000853: (3) REQUIRED SERVICES.—
p.000853: (A) IN GENERAL.—The Director shall specify a min- imum set of services required to be made available to eligi-
p.000853: ble women through a grant awarded under the pilot pro- gram under this subsection. Such minimum set of
p.000853: serv- ices—
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p.000853: (i) shall include the services requirements de- scribed in subsection (c) and be based on the rec-
p.000853: ommendations submitted under subparagraph (B); and
p.000853: (ii) may be selected from among the services de- scribed in subsection (d) and include other services as
p.000853: appropriate.
p.000853: (B) STAKEHOLDER INPUT.—The Director shall convene and solicit recommendations from stakeholders, including
p.000853: State substance abuse agencies, health care providers, per- sons in recovery from substance abuse, and other
p.000853: appro- priate individuals, for the minimum set of services de- scribed in subparagraph (A).
p.000853: (4) DURATION.—The pilot program under this subsection shall not exceed 5 years.
p.000853: (5) EVALUATION AND REPORT TO CONGRESS.—
p.000853: (A) IN GENERAL.—The Director of the Center for Be- havioral Health Statistics and Quality shall evaluate
p.000853: the pilot program at the conclusion of the first grant cycle funded by the pilot program.
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p.000855: PUBLIC HEALTH SERVICE ACT
p.000855: Sec. 509
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p.000855: (B) REPORT.—The Director of the Center for Behav- ioral Health Statistics and Quality, in coordination
p.000855: with the Director of the Center for Substance Abuse Treatment shall submit to the relevant committees of
p.000855: jurisdiction of the House of Representatives and the Senate a report on the evaluation under subparagraph
p.000855: (A). The report shall include, at a minimum—
p.000855: (i) outcomes information from the pilot program, including any resulting reductions in the use of alcohol and
p.000855: other drugs;
p.000855: (ii) engagement in treatment services;
p.000855: (iii) retention in the appropriate level and dura- tion of services;
p.000855: (iv) increased access to the use of medications ap- proved by the Food and Drug Administration for the
p.000855: treatment of substance use disorders in combination with counseling; and
p.000855: (v) other appropriate measures.
p.000855: (C) RECOMMENDATION.—The report under subpara- graph (B) shall include a recommendation by the Director
p.000855: of the Center for Substance Abuse Treatment as to wheth- er the pilot program under this subsection should be
p.000855: ex- tended.
p.000855: (6) STATE SUBSTANCE ABUSE AGENCIES DEFINED.—For pur- poses of this subsection, the term ‘‘State substance abuse
p.000855: agen- cy’’ means, with respect to a State, the agency in such State that manages the Substance Abuse
p.000855: Prevention and Treatment Block Grant under part B of title XIX.
p.000855: (s) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000855: to be appropriated
p.000855: $29,931,000 for each of fiscal years 2019 through 2023. Of the amounts made available for a year
p.000855: pursuant to theprevious sen- tence to carry out this section, not more than25 percent of such amounts
p.000855: shall be made available for suchyear to carry out sub- section (r), other than paragraph (5) ofsuch
p.000855: subsection. Notwith- standing the preceding sentence, nofunds shall be made available to carry out subsection
p.000855: (r) fora fiscal year unless the amount made available to carry outthis section for such fiscal year is more
p.000855: than the amount madeavailable to carry out this section for fiscal year 2016.
p.000855: SEC. 509. ø290bb–2¿ PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS OF REGIONAL AND NATIONAL SIGNIFICANCE.
p.000855: (a) PROJECTS.—The Secretary shall address priority substance use disorder treatment needs of regional and
p.000855: national significance (as determined under subsection (b)) through the provision of or through assistance
p.000855: for—
p.000855: (1) knowledge development and application projects for treatment and rehabilitation and the conduct or
p.000855: support of evaluations of such projects;
p.000855: (2) training and technical assistance; and
p.000855: (3) targeted capacity response programs that permit States, local governments, communities, and Indian
p.000855: tribes and tribal organizations (as the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in
p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000855:
p.000855: mination and Education Assistance Act) to focus on emerging trends in substance abuse and co-occurrence
p.000855: of substance use disorders with mental illness or other conditions.
p.000855: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000855: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000855: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000855: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000855: public or nonprofit private entities.
p.000855: (b) PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS.—
p.000855: (1) IN GENERAL.—Priority substance use disorder treat- ment needs of regional and national significance shall be
p.000855: deter- mined by the Secretary after consultation with States and other interested groups. The Secretary
p.000855: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000855: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000855: con- sideration to promoting the integration of substance use dis- order treatment services into primary health
p.000855: care systems.
p.000855: (c) REQUIREMENTS.—
p.000855: (1) IN GENERAL.—Recipients of grants, contracts, or cooper- ative agreements under this section shall comply with
p.000855: informa- tion and application requirements determined appropriate by the Secretary.
p.000855: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000855: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000855: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000855: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
p.000855: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000855: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
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p.000855: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: PUBLIC HEALTH SERVICE ACT
p.000857: Sec. 513
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p.000857: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000857: programs to dissemi- nate and apply the findings of the knowledge development and ap- plication, training and technical
p.000857: assistance programs, and targeted capacity response programs under this section to the general pub- lic, to
p.000857: health professionals and other interested groups. The Sec- retary shall make every effort to provide linkages
p.000857: between the find- ings of supported projects and State agencies responsible for car- rying out substance
p.000857: use disorder prevention and treatment pro- grams.
p.000857: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000857: $333,806,000 for each of fiscal years 2018 through 2022.
p.000857: ACTION BY NATIONAL INSTITUTE ON DRUG ABUSE AND STATES CONCERNING MILITARY FACILITIES
p.000857: SEC. 513. 7 ø290bb–6¿ (a) CENTER FOR SUBSTANCE ABUSE
p.000857: TREATMENT.—The Director of the Center for Substance Abuse Treatment shall—
p.000857: (1) coordinate with the agencies represented on the Com- mission on Alternative Utilization of Military
p.000857: Facilities the uti- lization of military facilities or parts thereof, as identified by such Commission,
p.000857: established under the National Defense Au- thorization Act of 1989, that could be utilized or renovated to
p.000857: house nonviolent persons for drug treatment purposes;
p.000857: (2) notify State agencies responsible for the oversight of drug abuse treatment entities and programs of the
p.000857: availability of space at the installations identified in paragraph (1); and
p.000857: (3) assist State agencies responsible for the oversight of drug abuse treatment entities and programs in
p.000857: developing methods for adapting the installations described in paragraph
p.000857: (1) into residential treatment centers.
p.000857: (b) STATES.—With regard to military facilities or parts thereof, as identified by the Commission on Alternative
p.000857: Utilization of Mili- tary Facilities established under section 3042 of the Comprehensive Alcohol Abuse, Drug Abuse,
p.000857: and Mental Health Amendments Act of 1988, that could be utilized or renovated to house nonviolent per- sons for
p.000857: drug treatment purposes, State agencies responsible for the oversight of drug abuse treatment
p.000857: entities and programs shall—
p.000857: (1) establish eligibility criteria for the treatment of individ- uals at such facilities;
p.000857: (2) select treatment providers to provide drug abuse treat- ment at such facilities;
p.000857: (3) provide assistance to treatment providers selected under paragraph (2) to assist such providers
p.000857: in securing fi- nancing to fund the cost of the programs at such facilities; and
p.000857: (4) establish, regulate, and coordinate with the military of- ficial in charge of the facility, work programs
p.000857: for individuals receiving treatment at such facilities.
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p.000857: January 30, 2020
p.000857: 7 Sections 510 through 512 were repealed by section 3301(c) of Public Law 106–310 (114 Stat.
p.000857: 1209).
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p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
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p.000859: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or cooperative agreement, a plan for the evaluation of any
p.000859: project undertaken with funds provided under this section. Such entity shall provide the Secretary with
p.000859: periodic evaluations of the progress of such project and such eval- uation at the completion of such
p.000859: project as the Secretary deter- mines to be appropriate.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000859: $29,605,000 for each of fiscal years 2018 through 2022.
p.000859: øSection 514A was repealed by section 9017 of Public Law 114–255.¿
p.000859: SEC. 514B. ø290bb–10¿ EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND INTERVENTIONS DEMONSTRA-
p.000859: TION.
p.000859: (a) GRANTS TO EXPAND ACCESS.—
p.000859: (1) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements to
p.000859: State substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes and tribal
p.000859: organizations (as defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act) that have
p.000859: a high rate, or have had a rapid increase, in the use of heroin or other opioids, in order to permit
p.000859: such entities to expand activities, including an ex- pansion in the availability of evidence-based
p.000859: medication-as- sisted treatment and other clinically appropriate services, with respect to the treatment of
p.000859: addiction in the specific geo- graphical areas of such entities where there is a high rate or rapid
p.000859: increase in the use of heroin or other opioids, such as in rural areas.
p.000859: (2) NATURE OF ACTIVITIES.—Funds awarded under para- graph (1) shall be used for activities that are based on
p.000859: reliable scientific evidence of efficacy in the treatment of problems re- lated to heroin or other opioids.
p.000859: (b) APPLICATION.—To be eligible for a grant, contract, or coop- erative agreement under subsection (a),
p.000859: an entity shall submit an application to the Secretary at such time, in such manner, and ac- companied by such
p.000859: information as the Secretary may reasonably require.
p.000859: (c) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or agreement a plan for the eval- uation of any project
p.000859: undertaken with funds provided under this section. Such entity shall provide the Secretary with periodic eval-
p.000859: uations of the progress of such project and an evaluation at the completion of such project as the Secretary
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p.000859: Sec. 515 PUBLIC HEALTH SERVICE ACT 860
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p.000859: shall take into account the unique needs of rural communities, in- cluding communities with an incidence of
p.000859: individuals with opioid use disorder that is above the national average and communities with a shortage of
p.000859: prevention and treatment services.
p.000859: (e) ADDITIONAL ACTIVITIES.—In administering grants, con- tracts, and cooperative agreements under
p.000859: subsection (a), the Sec- retary shall—
p.000859: (1) evaluate the activities supported under such sub- section;
p.000859: (2) disseminate information, as appropriate, derived from evaluations as the Secretary considers appropriate;
p.000859: (3) provide States, Indian tribes and tribal organizations, and providers with technical assistance in
p.000859: connection with the provision of treatment of problems related to heroin and other opioids; and
p.000859: (4) fund only those applications that specifically support recovery services as a critical component of
p.000859: the program in- volved.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000859: $25,000,000 for each of fiscal years 2017 through 2021.
p.000859: Subpart 2—Center for Substance Abuse Prevention
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p.000859: CENTER FOR SUBSTANCE ABUSE PREVENTION
p.000859: SEC. 515. ø290bb–21¿ (a) There is established in the Adminis- tration a Center for Substance Abuse Prevention
p.000859: (hereafter re- ferred to in this part as the ‘‘Prevention Center’’). The Prevention Center shall be
p.000859: headed by a Director appointed by the Secretary from individuals with extensive experience or academic
p.000859: qualifica- tions in the prevention of drug or alcohol abuse.
p.000859: (b) The Director of the Prevention Center shall—
p.000859: (1) sponsor regional workshops on the prevention of drug and alcohol abuse through the reduction of risk
p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
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p.000861: Sec. 516
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
p.000861: under the Drug Free Schools and Communities Act of 1986;
p.000861: (9) support the development of model, innovative, commu- nity-based programs that reduce the risk of
p.000861: alcohol and drug abuse among young people and promote resiliency;
p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: Sec. 516 PUBLIC HEALTH SERVICE ACT 862
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p.000861:
p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
p.000861: (B) promoting the integration of substance use dis- order prevention information and activities into
p.000861: primary health care systems; and
p.000861: (C) substance use disorder prevention among high-risk groups.
p.000861: (c) REQUIREMENTS.—
p.000861: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000861: infor- mation and application requirements determined appropriate by the Secretary.
p.000861: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000861: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000861: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000861: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
...

p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
p.000863: (3) The term ‘‘youth’’ means persons under the age of 21.
p.000863: (4) The term ‘‘IOM report’’ means the report released in September 2003 by the National Research Council,
p.000863: Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collec- tive Responsibility’’.
p.000863: (b) SENSE OF CONGRESS.—It is the sense of the Congress that:
p.000863: (1) A multi-faceted effort is needed to more successfully ad- dress the problem of underage drinking in the
p.000863: United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to
p.000863: making progress. This Act recognizes the need for a focused national effort, and addresses particulars of the Federal
p.000863: portion of that effort, as well as Fed- eral support for State activities.
p.000863: (2) The Secretary of Health and Human Services shall con- tinue to conduct research and collect data on the
p.000863: short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ
p.000863: systems.
p.000863: (3) States and communities, including colleges and univer- sities, are encouraged to adopt comprehensive
p.000863: prevention ap- proaches, including—
p.000863: (A) evidence-based screening, programs and curricula;
p.000863: (B) brief intervention strategies;
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: Sec. 519B PUBLIC HEALTH SERVICE ACT 864
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p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
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p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
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p.000869: under this paragraph shall not exceed $50,000 per year and may not exceed four years.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: not supplant, Federal and non-Federal funds available for carrying out the activities described in this
p.000869: paragraph.
p.000869: (F) EVALUATION.—Grants under this paragraph shall be subject to the same evaluation requirements and proce- dures
p.000869: as the evaluation requirements and procedures im- posed on recipients of drug free community grants.
p.000869: (G) DEFINITIONS.—For purposes of this paragraph, the term ‘‘eligible entity’’ means an organization that is
p.000869: cur- rently receiving or has received grant funds under the Drug-Free Communities Act of 1997 (21 U.S.C.
p.000869: 1521 et seq.).
p.000869: (H) ADMINISTRATIVE EXPENSES.—Not more than 6 per- cent of a grant under this paragraph may be expended for
p.000869: administrative expenses.
p.000869: (I) AUTHORIZATION OF APPROPRIATIONS.—There are au- thorized to be appropriated to carry out this paragraph
p.000869: $5,000,000 for each of the fiscal years 2018 through 2022.
p.000869: (2) GRANTS DIRECTED AT PREVENTING AND REDUCING ALCO- HOL ABUSE AT INSTITUTIONS OF HIGHER EDUCATION.—
p.000869: (A) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to eligible entities to enable the entities to
p.000869: prevent and reduce the rate of underage alcohol consump- tion including binge drinking among students at
p.000869: institu- tions of higher education.
p.000869: (B) APPLICATIONS.—An eligible entity that desires to receive a grant under this paragraph shall submit an
p.000869: ap- plication to the Secretary at such time, in such manner, and accompanied by such information as the
p.000869: Secretary may require. Each application shall include—
p.000869: (i) a description of how the eligible entity will work to enhance an existing, or where none exists to
p.000869: build a, statewide coalition;
p.000869: (ii) a description of how the eligible entity will tar- get underage students in the State;
p.000869: (iii) a description of how the eligible entity intends to ensure that the statewide coalition is actually im-
p.000869: plementing the purpose of this section and moving to- ward indicators described in subparagraph (D);
p.000869: (iv) a list of the members of the statewide coali- tion or interested parties involved in the work of
p.000869: the eligible entity;
p.000869: (v) a description of how the eligible entity intends to work with State agencies on substance abuse pre-
p.000869: vention and education;
p.000869: (vi) the anticipated impact of funds provided under this paragraph in preventing and reducing the
p.000869: rates of underage alcohol use;
p.000869: (vii) outreach strategies, including ways in which the eligible entity proposes to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000869: Sec. 519B PUBLIC HEALTH SERVICE ACT 870
p.000869:
p.000869: (I) reach out to students and community stakeholders;
p.000869: (II) promote the purpose of this paragraph;
p.000869: (III) address the range of needs of the stu- dents and the surrounding communities; and
p.000869: (IV) address community norms for underage students regarding alcohol use; and
p.000869: (viii) such additional information as required by the Secretary.
p.000869: (C) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000869: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph (B).
p.000869: (D) ACCOUNTABILITY.—On the date on which the Sec- retary first publishes a notice in the Federal Register solic-
p.000869: iting applications for grants under this paragraph, the Sec- retary shall include in the notice achievement
p.000869: indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
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p.000869: (iii) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Education.
p.000869: (iv) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Common- wealth of
p.000869: Puerto Rico.
p.000869: (v) STATEWIDE COALITION.—The term ‘‘statewide coalition’’ means a coalition that—
p.000869: (I) includes, but is not limited to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: PUBLIC HEALTH SERVICE ACT
p.000871: Sec. 519B
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p.000871: (aa) institutions of higher education with- in a State; and
p.000871: (bb) a nonprofit group, a community un- derage drinking prevention coalition, or an- other substance abuse
p.000871: prevention group with- in a State; and
p.000871: (II) works toward lowering the alcohol abuse rate by targeting underage students at institu- tions of
p.000871: higher education throughout the State and in the surrounding communities.
p.000871: (vi) SURROUNDING COMMUNITY.—The term ‘‘sur- rounding community’’ means the community—
p.000871: (I) that surrounds an institution of higher education participating in a statewide coalition;
p.000871: (II) where the students from the institution of higher education take part in the community; and
p.000871: (III) where students from the institution of higher education live in off-campus housing.
p.000871: (G) ADMINISTRATIVE EXPENSES.—Not more than 5 per- cent of a grant under this paragraph may be expended for
p.000871: administrative expenses.
p.000871: (H) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this
p.000871: paragraph
p.000871: $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
p.000871: (f) ADDITIONAL RESEARCH.—
p.000871: (1) ADDITIONAL RESEARCH ON UNDERAGE DRINKING.—
p.000871: (A) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, collect data, and
p.000871: conduct or support research that is not duplicative of research cur- rently being conducted or supported by
p.000871: the Department of Health and Human Services, on underage drinking, with respect to the following:
p.000871: (i) Comprehensive community-based programs or strategies and statewide systems to prevent and re- duce
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p.000873: techniques for the prevention of fetal alcohol syndrome and alcohol-related birth defects and adaptations of inno-
p.000873: vative clinical interventions and service delivery improvements for the provision of comprehensive services to
p.000873: individuals with fetal al- cohol syndrome or alcohol-related birth defects and their families and for providing
p.000873: training on such conditions.
p.000873: (b) USE OF FUNDS.—An award under subsection (a) may be used to—
p.000873: (1) study adaptations of innovative clinical interventions and service delivery improvements strategies for
p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
p.000873: (3) provide technical assistance to communities who do not have a comprehensive system of care for such
p.000873: individuals and their families;
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000873: (4) train community leaders, mental health and substance abuse professionals, families, law enforcement
p.000873: personnel, judges, health professionals, persons working in financial as- sistance programs, social service
p.000873: personnel, child welfare pro- fessionals, and other service providers on the implications of fetal alcohol
p.000873: syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
p.000873: (5) develop innovative techniques for preventing alcohol use by women in child bearing years; 9
p.000873: (6) perform other functions, to the extent authorized by the Secretary after consideration of recommendations made by
p.000873: the National Task Force on Fetal Alcohol Syndrome.
p.000873: (c) REPORT.—
p.000873: (1) IN GENERAL.—A recipient of an award under subsection
p.000873: (a) shall at the end of the period of funding report to the Sec- retary on any innovative techniques that have been
p.000873: discovered for preventing alcohol use among women of child bearing years.
p.000873: (2) DISSEMINATION OF FINDINGS.—The Secretary shall upon receiving a report under paragraph (1) disseminate the
p.000873: find- ings to appropriate public and private entities.
p.000873: (d) DURATION OF AWARDS.—With respect to an award under subsection (a), the period during which
p.000873: payments under such award are made to the recipient may not exceed 5 years.
p.000873: (e) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a) and shall disseminate
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p.000883: 10 The probable intent of the Congress is that the heading be ‘‘SUICIDE PREVENTION FOR YOUTH’’. See the amendment
p.000883: described in section 3(b)(1)(A) of Public Law 108–355 (118 Stat. 1407). The amendment cannot be executed
p.000883: because the matter in the heading to be struck does not appear, as the amendatory instruction used the wrong
p.000883: font. The amendment referred to ‘‘CHILDREN AND ADOLESCENTS’’ rather than ‘‘CHILDREN AND ADOLESCENTS’’. (The
p.000883: amendment is directed to section ‘‘520E’’. Section 520E–1 above formerly was section 520E, and was redesignated by
p.000883: section 3(b)(2) of such Public Law.)
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p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
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p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
p.000883: (B) in the case of a consortium of States, receive the sup- port of all States involved;
p.000883: (2) provide for the timely assessment, treatment, or refer- ral for mental health or substance abuse
p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
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p.000893: tributed among the geographical regions of the United States and between urban and rural populations.
p.000893: (h) TRAINING AND TECHNICAL ASSISTANCE.—Training and tech- nical assistance may be provided by the Secretary to
p.000893: assist a State, political subdivision of a State, Indian tribe, or tribal organization receiving a grant under
p.000893: subsection (a) in establishing and operating a diversion program.
p.000893: (i) EVALUATIONS.—The programs described in subsection (a) shall be evaluated not less than one time in every
p.000893: 12-month period using the methodology and outcome measures identified in the grant application.
p.000893: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000893: $4,269,000 for each of fiscal years 2018 through 2022.
p.000893: øSection 520H was repealed by section 9017 of Public Law 114–255.¿
p.000893: SEC. 520I. ø290bb–40¿ GRANTS FOR THE INTEGRATED TREATMENT OF SERIOUS MENTAL ILLNESS AND CO-OCCURRING
p.000893: SUB- STANCE ABUSE.
p.000893: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to States, political
p.000893: subdivisions of States, Indian tribes, tribal organizations, and private nonprofit or- ganizations for the
p.000893: development or expansion of programs to pro- vide integrated treatment services for individuals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder.
p.000893: (b) PRIORITY.—In awarding grants, contracts, and cooperative agreements under subsection (a), the Secretary
p.000893: shall give priority to applicants that emphasize the provision of services for individ- uals with a
p.000893: serious mental illness and a co-occurring substance abuse disorder who—
p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: Sec. 520J PUBLIC HEALTH SERVICE ACT 894
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p.000893: previously provided only mental health services or only sub- stance abuse services; and
p.000893: (6) to provide services in coordination with other existing public and private community programs.
p.000893: (d) CONDITION.—The Secretary shall ensure that a State, polit- ical subdivision of a State, Indian tribe, tribal
p.000893: organization, or pri- vate nonprofit organization that receives a grant, contract, or coop- erative agreement under
p.000893: subsection (a) maintains the level of effort necessary to sustain existing mental health and substance abuse
p.000893: programs for other populations served by mental health systems in the community.
p.000893: (e) DISTRIBUTION OF AWARDS.—The Secretary shall ensure that grants, contracts, or cooperative agreements awarded
p.000893: under sub- section (a) are equitably distributed among the geographical re- gions of the United States
p.000893: and between urban and rural popu- lations.
p.000893: (f) DURATION.—The Secretary shall award grants, contract, or cooperative agreements under this subsection
p.000893: for a period of not more than 5 years.
p.000893: (g) APPLICATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or
p.000893: private nonprofit organization that desires a grant, contract, or cooperative agreement under this subsection shall
p.000893: prepare and submit an application to the Secretary at such time, in such manner, and containing such
p.000893: information as the Secretary may require. Such application shall include a plan for the rigorous
p.000893: evaluation of activities funded with an award under such subsection, including a process and outcomes
p.000893: evalua- tion.
p.000893: (h) EVALUATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
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p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000907: Sec. 535 PUBLIC HEALTH SERVICE ACT 908
p.000907:
p.000907: (2) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ has the meaning given such term in
p.000907: section 330(h)(5).
p.000907: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000907: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.000907: (4) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘sub- stance use disorder services’’ has the meaning
p.000907: given the term ‘‘substance abuse services’’ in section 330(h)(5)(C).
p.000907: SEC. 535. ø290cc–35¿ FUNDING.
p.000907: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there is authorized to
p.000907: be appropriated
p.000907: $64,635,000 for each of fiscal years 2018 through 2022.
p.000907: (b) EFFECT OF INSUFFICIENT APPROPRIATIONS FOR MINIMUM ALLOTMENTS.—
p.000907: (1) IN GENERAL.—If the amounts made available under subsection (a) for a fiscal year are insufficient
p.000907: for providing each State with an allotment under section 521 of not less than the applicable amount under section
p.000907: 524(a)(1), the Secretary shall, from such amounts as are made available under such subsection, make grants
p.000907: to the States for providing to eligible homeless individuals the services specified in section 522(b).
p.000907: (2) RULE OF CONSTRUCTION.—Paragraph (1) may not be construed to require the Secretary to make a grant under such
p.000907: paragraph to each State.
p.000907: PART D—MISCELLANEOUS PROVISIONS RELATING TO SUBSTANCE ABUSE AND MENTAL HEALTH
p.000907: SEC. 541. ø290dd¿ SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
p.000907: (a) PROGRAMS AND SERVICES.—
p.000907: (1) DEVELOPMENT.—The Secretary, acting through the As- sistant Secretary for Mental Health and Substance
p.000907: Use, shall be responsible for fostering substance abuse prevention and treatment programs and services in
p.000907: State and local govern- ments and in private industry.
p.000907: (2) MODEL PROGRAMS.—
p.000907: (A) IN GENERAL.—Consistent with the responsibilities described in paragraph (1), the Secretary, acting
p.000907: through the Assistant Secretary for Mental Health and Substance Use, shall develop a variety of model programs
p.000907: suitable for replication on a cost-effective basis in different types of business concerns and State and
p.000907: local governmental enti- ties.
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p.000907: January 30, 2020
p.000907: (B) DISSEMINATION OF INFORMATION.—The Secretary, acting through the Assistant Secretary for Mental Health
p.000907: and Substance Use, shall disseminate information and ma- terials relative to such model programs to the State agen-
p.000907: cies responsible for the administration of substance abuse prevention, treatment, and rehabilitation
p.000907: activities and shall, to the extent feasible provide technical assistance to such agencies as requested.
p.000907: (b) DEPRIVATION OF EMPLOYMENT.—
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000909: 909
p.000909: PUBLIC HEALTH SERVICE ACT
p.000909: Sec. 542
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p.000909: January 30, 2020
p.000909: (1) PROHIBITION.—No person may be denied or deprived of Federal civilian employment or a Federal professional or other
p.000909: license or right solely on the grounds of prior substance abuse.
p.000909: (2) APPLICATION.—This subsection shall not apply to em- ployment in—
p.000909: (A) the Central Intelligence Agency;
p.000909: (B) the Federal Bureau of Investigation;
p.000909: (C) the National Security Agency;
p.000909: (D) any other department or agency of the Federal Government designated for purposes of national security
p.000909: by the President; or
p.000909: (E) in any position in any department or agency of the Federal Government, not referred to in subparagraphs (A) through
p.000909: (D), which position is determined pursuant to reg- ulations prescribed by the head of such agency or depart-
p.000909: ment to be a sensitive position.
p.000909: (3) REHABILITATION ACT.—The inapplicability of the prohi- bition described in paragraph (1) to the employment described
p.000909: in paragraph (2) shall not be construed to reflect on the appli- cability of the Rehabilitation Act of 1973 or other
p.000909: anti-discrimi- nation laws to such employment.
p.000909: (c) CONSTRUCTION.—This section shall not be construed to pro- hibit the dismissal from employment of a Federal civilian
p.000909: employee who cannot properly function in his employment.
p.000909: SEC. 542. ø290dd–1¿ ADMISSION OF SUBSTANCE ABUSERS TO PRIVATE AND PUBLIC HOSPITALS AND OUTPATIENT FACILITIES.
p.000909: (a) NONDISCRIMINATION.—Substance abusers who are suffering from medical conditions shall not be discriminated
p.000909: against in ad- mission or treatment, solely because of their substance abuse, by any private or public
p.000909: general hospital, or outpatient facility (as de- fined in section 1624(4)) which receives support in any form
p.000909: from any program supported in whole or in part by funds appropriated to any Federal department or agency.
p.000909: (b) REGULATIONS.—
p.000909: (1) IN GENERAL.—The Secretary shall issue regulations for the enforcement of the policy of subsection (a) with
p.000909: respect to the admission and treatment of substance abusers in hospitals and outpatient facilities which receive
p.000909: support of any kind from any program administered by the Secretary. Such regula- tions shall include procedures
p.000909: for determining (after oppor- tunity for a hearing if requested) if a violation of subsection (a) has occurred,
p.000909: notification of failure to comply with such sub- section, and opportunity for a violator to comply with such
p.000909: sub- section. If the Secretary determines that a hospital or out- patient facility subject to such
p.000909: regulations has violated sub- section (a) and such violation continues after an opportunity has been
p.000909: afforded for compliance, the Secretary may suspend or revoke, after opportunity for a hearing, all or
p.000909: part of any support of any kind received by such hospital from any pro- gram administered by the
p.000909: Secretary. The Secretary may con- sult with the officials responsible for the administration of any other Federal
p.000909: program from which such hospital or outpatient facility receives support of any kind, with respect to the
p.000909: sus-
p.000909: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000909: Sec. 543 PUBLIC HEALTH SERVICE ACT 910
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p.000909: January 30, 2020
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p.000909: pension or revocation of such other Federal support for such hospital or outpatient facility.
p.000909: (2) DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Under
p.000909: Secretary for Health, shall, to the maximum feasible extent consistent with their responsibilities under
p.000909: title 38, United States Code, pre- scribe regulations making applicable the regulations prescribed by the
p.000909: Secretary under paragraph (1) to the provision of hos- pital care, nursing home care, domiciliary care,
p.000909: and medical services under such title 38 to veterans suffering from sub- stance abuse. In prescribing
p.000909: and implementing regulations pursuant to this paragraph, the Secretary shall, from time to time, consult
p.000909: with the Secretary of Health and Human Serv- ices in order to achieve the maximum possible coordination
p.000909: of the regulations, and the implementation thereof, which they each prescribe.
p.000909: SEC. 543. ø290dd–2¿ CONFIDENTIALITY OF RECORDS.
p.000909: (a) REQUIREMENT.—Records of the identity, diagnosis, prog- nosis, or treatment of any patient which are
p.000909: maintained in connec- tion with the performance of any program or activity relating to substance abuse
p.000909: education, prevention, training, treatment, reha- bilitation, or research, which is conducted, regulated, or
p.000909: directly or indirectly assisted by any department or agency of the United States shall, except as provided
p.000909: in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly
p.000909: authorized under subsection (b).
p.000909: (b) PERMITTED DISCLOSURE.—
p.000909: (1) CONSENT.—The content of any record referred to in subsection (a) may be disclosed in accordance with
p.000909: the prior written consent of the patient with respect to whom such record is maintained, but only to
p.000909: such extent, under such cir- cumstances, and for such purposes as may be allowed under regulations
p.000909: prescribed pursuant to subsection (g).
p.000909: (2) METHOD FOR DISCLOSURE.—Whether or not the patient, with respect to whom any given record referred to in
p.000909: sub- section (a) is maintained, gives written consent, the content of such record may be disclosed as follows:
p.000909: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
p.000909: (B) To qualified personnel for the purpose of con- ducting scientific research, management audits,
p.000909: financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any
p.000909: individual patient in any report of such research, audit, or evaluation, or other- wise disclose patient identities
p.000909: in any manner.
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p.000911: mining the extent to which any disclosure of all or any part of any record is necessary, shall impose
p.000911: appropriate safeguards against unauthorized disclosure.
p.000911: (c) USE OF RECORDS IN CRIMINAL PROCEEDINGS.—Except as au- thorized by a court order granted under
p.000911: subsection (b)(2)(C), no record referred to in subsection (a) may be used to initiate or sub- stantiate any criminal
p.000911: charges against a patient or to conduct any investigation of a patient.
p.000911: (d) APPLICATION.—The prohibitions of this section continue to apply to records concerning any individual who has
p.000911: been a patient, irrespective of whether or when such individual ceases to be a pa- tient.
p.000911: (e) NONAPPLICABILITY.—The prohibitions of this section do not apply to any interchange of records—
p.000911: (1) within the Uniformed Services or within those compo- nents of the Department of Veterans Affairs furnishing
p.000911: health care to veterans; or
p.000911: (2) between such components and the Uniformed Services. The prohibitions of this section do not apply to the reporting
p.000911: under State law of incidents of suspected child abuse and neglect to the appropriate State or local
p.000911: authorities.
p.000911: (f) PENALTIES.—Any person who violates any provision of this section or any regulation issued pursuant to
p.000911: this section shall be fined in accordance with title 18, United States Code.
p.000911: (g) REGULATIONS.—Except as provided in subsection (h), the Secretary shall prescribe regulations to carry
p.000911: out the purposes of this section. Such regulations may contain such definitions, and may provide for such
p.000911: safeguards and procedures, including proce- dures and criteria for the issuance and scope of orders
p.000911: under sub- section (b)(2)(C), as in the judgment of the Secretary are necessary or proper to effectuate the
p.000911: purposes of this section, to prevent cir- cumvention or evasion thereof, or to facilitate compliance
p.000911: there- with.
p.000911: (h) APPLICATION TO DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Chief
p.000911: Medical Di- rector, shall, to the maximum feasible extent consistent with their responsibilities under title 38,
p.000911: United States Code, prescribe regu- lations making applicable the regulations prescribed by the Sec- retary
p.000911: of Health and Human Services under subsection (g) of this section to records maintained in connection
p.000911: with the provision of hospital care, nursing home care, domiciliary care, and medical services under such
p.000911: title 38 to veterans suffering from substance abuse. In prescribing and implementing regulations pursuant
p.000911: to this subsection, the Secretary of Veterans Affairs shall, from time to time, consult with the Secretary of
p.000911: Health and Human Services in order to achieve the maximum possible coordination of the regu- lations, and the
p.000911: implementation thereof, which they each prescribe.
p.000911: SEC. 543A. ø290dd–2a¿ PROMOTING ACCESS TO INFORMATION ON EVI- DENCE-BASED PROGRAMS AND PRACTICES.
p.000911: (a) IN GENERAL.—The Assistant Secretary shall, as appro- priate, improve access to reliable and valid
p.000911: information on evi- dence-based programs and practices, including information on the strength of evidence
p.000911: associated with such programs and practices, related to mental and substance use disorders for States, local com-
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: Sec. 544 PUBLIC HEALTH SERVICE ACT 912
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p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000913: opioid overdose, the practice of prescribing such drug or device—
p.000913: (A) in conjunction with an opioid prescription for pa- tients at an elevated risk of overdose;
p.000913: (B) in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act
p.000913: for the treatment of opioid use disorder;
p.000913: (C) to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or
p.000913: (D) in other circumstances in which a provider identi- fies a patient is at an elevated risk for an
p.000913: intentional or unintentional drug overdose from heroin or prescription opioid therapies.
p.000913: (b) APPLICATION.—To be eligible to receive a grant under this section, an eligible entity shall submit
p.000913: to the Secretary, in such form and manner as specified by the Secretary, an application that describes—
p.000913: (1) the extent to which the area to which the entity will furnish services through use of the grant
p.000913: is experiencing sig- nificant morbidity and mortality caused by opioid abuse;
p.000913: (2) the criteria that will be used to identify eligible pa- tients to participate in such program; and
p.000913: (3) a plan for sustaining the program after Federal support for the program has ended.
p.000913: (c) USE OF FUNDS.—An eligible entity receiving a grant under this section may use amounts under the
p.000913: grant for any of the fol- lowing activities, but may use not more than 20 percent of the grant funds
p.000913: for activities described in paragraphs (3) and (4):
p.000913: (1) To establish a program for prescribing a drug or device approved or cleared under the Federal Food, Drug,
p.000913: and Cos- metic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (2) To train and provide resources for health care providers and pharmacists on the prescribing of drugs or
p.000913: devices ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose.
p.000913: (3) To purchase drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000913: treat- ment of known or suspected opioid overdose, for distribution under the program described in paragraph
p.000913: (1).
p.000913: (4) To offset the co-payments and other cost sharing associ- ated with drugs or devices approved or cleared under the
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p.000913: (c) PREFERENCE IN MAKING GRANTS.—In making grants under this section, the Secretary may give preference to States
p.000913: that have a significantly higher rate of opioid overdoses than the national av- erage, and that—
p.000913: (1) have not implemented standing orders regarding drugs or devices approved or cleared under the Federal Food,
p.000913: Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose;
p.000913: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: 915
p.000915: PUBLIC HEALTH SERVICE ACT
p.000915: Sec. 546
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p.000915: (2) authorize standing orders to be issued that permit com- munity-based organizations, substance abuse
p.000915: programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved or
p.000915: cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000915: opioid overdose; or
p.000915: (3) authorize standing orders to be issued that permit po- lice, fire, or emergency medical services
p.000915: agencies to acquire and administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose.
p.000915: (d) GRANT TERMS.—
p.000915: (1) NUMBER.—A State may not receive more than one grant under this section at a time.
p.000915: (2) PERIOD.—A grant under this section shall be for a pe- riod of 3 years.
p.000915: (3) LIMITATION.—A State may use not more than 20 per- cent of a grant under this section for educating the
p.000915: public pur- suant to subsection (a)(4).
p.000915: (e) APPLICATIONS.—To be eligible to receive a grant under this section, a State shall submit an application to
p.000915: the Secretary in such form and manner and containing such information as the Sec- retary may reasonably require,
p.000915: including detailed proposed expend- itures of grant funds.
p.000915: (f) REPORTING.—A State that receives a grant under this sec- tion shall, at least annually for the
p.000915: duration of the grant, submit a report to the Secretary evaluating the progress of the activities
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p.000915: metic Act for emergency treatment of known or suspected opioid overdose.
p.000915: (b) APPLICATION.—
p.000915: (1) IN GENERAL.—An entity seeking a grant under this sec- tion shall submit an application to the Secretary—
p.000915: (A) that meets the criteria under paragraph (2); and
p.000915: (B) at such time, in such manner, and accompanied by such information as the Secretary may require.
p.000915: (2) CRITERIA.—An entity, in submitting an application under paragraph (1), shall—
p.000915: (A) describe the evidence-based methodology and out- come measurements that will be used to evaluate the pro-
p.000915: gram funded with a grant under this section, and specifi- cally explain how such measurements will
p.000915: provide valid measures of the impact of the program;
p.000915: (B) describe how the program could be broadly rep- licated if demonstrated to be effective;
p.000915: (C) identify the governmental and community agencies with which the entity will coordinate to implement the
p.000915: program; and
p.000915: (D) describe how the entity will ensure that law en- forcement agencies will coordinate with
p.000915: their cor- responding State substance abuse and mental health agen- cies to identify protocols and resources
p.000915: that are available to overdose victims and families, including information on treatment and recovery
p.000915: resources.
p.000915: (c) USE OF FUNDS.—An entity shall use a grant received under this section to—
p.000915: (1) make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000915: treatment of known or suspected opioid overdose available to be carried and administered by first
p.000915: responders and members of other key community sectors;
p.000915: (2) train and provide resources for first responders and members of other key community sectors on
p.000915: carrying and ad- ministering a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose;
p.000915: (3) establish processes, protocols, and mechanisms for re- ferral to appropriate treatment, which may
p.000915: include an out- reach coordinator or team to connect individuals receiving opioid overdose reversal
p.000915: drugs to followup services; and
p.000915: (4) train and provide resources for first responders and members of other key community sectors on
p.000915: safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure
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p.000919: 919
p.000919: PUBLIC HEALTH SERVICE ACT
p.000919: Sec. 548
p.000919:
p.000919: (1) training on identifying—
p.000919: (A) signs of substance use disorder;
p.000919: (B) resources to assist individuals with a substance use disorder, or resources for families of an individual
p.000919: with a substance use disorder; and
p.000919: (C) best practices for the delivery of recovery support services;
p.000919: (2) the provision of translation services, interpretation, or other such services for clients with limited
p.000919: English speaking proficiency;
p.000919: (3) data collection to support research, including for translational research;
p.000919: (4) capacity building; and
p.000919: (5) evaluation and improvement, as necessary, of the effec- tiveness of such services provided by recovery community
p.000919: orga- nizations.
p.000919: (c) BEST PRACTICES.—The Center established under subsection
p.000919: (a) shall periodically issue best practices for use by recovery com- munity organizations and peer support
p.000919: networks.
p.000919: (d) RECOVERY COMMUNITY ORGANIZATION.—In this section, the term ‘‘recovery community organization’’ has the
p.000919: meaning given such term in section 547.
p.000919: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000919: $1,000,000 for each of fiscal years 2019 through 2023.
p.000919: SEC. 548. ø290ee–3¿ STATE DEMONSTRATION GRANTS FOR COM- PREHENSIVE OPIOID ABUSE RESPONSE.
p.000919: (a) DEFINITIONS.—In this section:
p.000919: (1) DISPENSER.—The term ‘‘dispenser’’ has the meaning given the term in section 102 of the Controlled Substances
p.000919: Act (21 U.S.C. 802).
p.000919: (2) PRESCRIBER.—The term ‘‘prescriber’’ means a dispenser who prescribes a controlled substance, or the agent
p.000919: of such a dispenser.
p.000919: (3) PRESCRIBER OF A SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘prescriber of a schedule
p.000919: II, III, or IV controlled substance’’ does not include a prescriber of a sched- ule II, III, or IV controlled
p.000919: substance that dispenses the sub- stance—
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p.000919: (A) for use on the premises on which the substance is dispensed;
p.000919: (B) in a hospital emergency room, when the substance is in short supply;
p.000919: (C) for a certified opioid treatment program; or
p.000919: (D) in other situations as the Secretary may reason- ably determine.
p.000919: (4) SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘schedule II, III, or IV controlled substance’’
p.000919: means a con- trolled substance that is listed on schedule II, schedule III, or schedule IV of section 202(c)
p.000919: of the Controlled Substances Act.
p.000919: (b) GRANTS FOR COMPREHENSIVE OPIOID ABUSE RESPONSE.—
p.000919: (1) IN GENERAL.—The Secretary shall award grants to States, and combinations of States, to implement an
p.000919: integrated opioid abuse response initiative.
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: Sec. 548 PUBLIC HEALTH SERVICE ACT 920
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p.000919: January 30, 2020
p.000919:
p.000919: (2) PURPOSES.—A State receiving a grant under this sec- tion shall establish a comprehensive response
p.000919: plan to opioid abuse, which may include—
p.000919: (A) education efforts around opioid use, treatment, and addiction recovery, including education of residents,
p.000919: med- ical students, and physicians and other prescribers of schedule II, III, or IV controlled
p.000919: substances on relevant prescribing guidelines, the prescription drug monitoring program of the State
p.000919: described in subparagraph (B), and overdose prevention methods;
p.000919: (B) establishing, maintaining, or improving a com- prehensive prescription drug monitoring program to track
p.000919: dispensing of schedule II, III, or IV controlled substances, which may—
p.000919: (i) provide for data sharing with other States; and
p.000919: (ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled
p.000919: substances to access the prescription drug monitoring program of the State;
p.000919: (C) developing, implementing, or expanding prescrip- tion drug and opioid addiction treatment programs by—
p.000919: (i) expanding the availability of treatment for pre- scription drug and opioid addiction, including medica-
p.000919: tion-assisted treatment and behavioral health therapy, as appropriate;
p.000919: (ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug
p.000919: and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically ap-
p.000919: propriate; or
p.000919: (iii) developing, implementing, or expanding recov- ery support services and programs at high schools or
p.000919: institutions of higher education;
p.000919: (D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to
p.000919: prescription medications and opioids; and
p.000919: (E) advancing the education and awareness of the pub- lic, providers, patients, consumers, and other appropriate
p.000919: entities regarding the dangers of opioid abuse, safe dis- posal of prescription medications, and detection
p.000919: of early warning signs of opioid use disorders.
p.000919: (3) APPLICATION.—A State seeking a grant under this sec- tion shall submit to the Secretary an application in such
p.000919: form, and containing such information, as the Secretary may reason- ably require.
p.000919: (4) USE OF FUNDS.—A State that receives a grant under this section shall use the grant for the cost, including
p.000919: the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid
p.000919: abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established
p.000919: under paragraph (2).
p.000919: (5) PRIORITY CONSIDERATIONS.—In awarding grants under this section, the Secretary shall, as appropriate,
p.000919: give priority to a State that—
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000921: 921
p.000921: PUBLIC HEALTH SERVICE ACT
p.000921: Sec. 548
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p.000921: (A)(i) provides civil liability protection for first re- sponders, health professionals, and family members
p.000921: who have received appropriate training in administering a drug or device approved or cleared under the Federal
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p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
p.000923: for the pe- riod of fiscal years 2018 through 2022.
p.000923: SEC. 550. 15 ø290ee–5¿ NATIONAL RECOVERY HOUSING BEST PRAC- TICES.
p.000923: (a) BEST PRACTICES FOR OPERATING RECOVERY HOUSING.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities specified in paragraph
p.000923: (2), shall iden- tify or facilitate the development of best practices, which may include model laws
p.000923: for implementing suggested minimum standards, for operating recovery housing.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate—
p.000923: (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Men- tal
p.000923: Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for
p.000923: Medicare & Medicaid Services;
p.000923: (B) the Secretary of Housing and Urban Development;
p.000923: (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State
p.000923: Med- icaid programs, and State insurance agencies;
p.000923: (D) representatives of health insurance issuers;
p.000923: (E) national accrediting entities and reputable pro- viders of, and analysts of, recovery housing
p.000923: services, in- cluding Indian tribes, tribal organizations, and tribally
p.000923:
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p.000923: January 30, 2020
p.000923: 15 A second section 550 (relating to Sobriety Treatment and Recovery Teams) appears at the end of title V
p.000923: as added by section 8214 of Public Law 115–271.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
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p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
p.000939: SEC. 581. 19 ø290hh¿ CHILDREN AND VIOLENCE.
p.000939: (a) IN GENERAL.—The Secretary, in consultation with the Sec- retary of Education and the Attorney General, shall
p.000939: carry out di- rectly or through grants, contracts or cooperative agreements with public entities a program to assist
p.000939: local communities in developing ways to assist children in dealing with violence.
p.000939: (b) ACTIVITIES.—Under the program under subsection (a), the Secretary may—
p.000939: (1) provide financial support to enable local communities to implement programs to foster the health and
p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
p.000939:
p.000939: January 30, 2020
p.000939: 19 There is another part G in this title, which also begins with a section 581. See page 677. That
p.000939: part G relates to services provided through religious organizations.
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: Sec. 582 PUBLIC HEALTH SERVICE ACT 940
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p.000941: of the activities funded under the grant, con- tract or agreement, including both process and outcomes
p.000941: evalua- tion, and the submission of an evaluation at the end of the project period.
p.000941: (i) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000941: period during which payments under such an award will be made to the recipient shall not be less than 4 years,
p.000941: but shall not exceed 5 years. Such grants, contracts or agreements may be renewed.
p.000941: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000941: $63,887,000 for each of fiscal years 2019 through 2023.
p.000941: (k) SHORT TITLE.—This section may be cited as the ‘‘Donald J. Cohen National Child Traumatic Stress Initiative’’.
p.000941:
p.000941: PART H—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN FACILI- TIES
p.000941:
p.000941:
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p.000941: January 30, 2020
p.000941: SEC. 591. ø290ii¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN FACILITIES.
p.000941: (a) IN GENERAL.—A public or private general hospital, nursing facility, intermediate care facility, or other health
p.000941: care facility, that receives support in any form from any program supported in whole or in part with funds
p.000941: appropriated to any Federal department or agency shall protect and promote the rights of each resident of the
p.000941: facility, including the right to be free from physical or mental abuse, corporal punishment, and any
p.000941: restraints or involuntary se- clusions imposed for purposes of discipline or convenience.
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000941:
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p.000941: Sec. 592 PUBLIC HEALTH SERVICE ACT 942
p.000941:
p.000941: (b) REQUIREMENTS.—Restraints and seclusion may only be im- posed on a resident of a facility described in subsection
p.000941: (a) if—
p.000941: (1) the restraints or seclusion are imposed to ensure the physical safety of the resident, a staff
p.000941: member, or others; and
p.000941: (2) the restraints or seclusion are imposed only upon the written order of a physician, or other licensed
p.000941: practitioner per- mitted by the State and the facility to order such restraint or seclusion, that specifies
p.000941: the duration and circumstances under which the restraints are to be used (except in emergency cir- cumstances
p.000941: specified by the Secretary until such an order could reasonably be obtained).
p.000941: (c) CURRENT LAW.—This part shall not be construed to affect or impede any Federal or State law or
p.000941: regulations that provide greater protections than this part regarding seclusion and re- straint.
p.000941: (d) DEFINITIONS.—In this section:
p.000941: (1) RESTRAINTS.—The term ‘‘restraints’’ means—
p.000941: (A) any physical restraint that is a mechanical or per- sonal restriction that immobilizes or reduces the ability of an
...

p.000943: that section, however, section 593 appeared in quotations, and closing quotations were provided at the end of the
p.000943: section. The probable intent of the Congress is that closing quotations should not have been provided at
p.000943: the end of section 592.
p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000943:
p.000943:
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p.000943: Sec. 595 PUBLIC HEALTH SERVICE ACT 944
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p.000943: January 30, 2020
p.000943:
p.000943: in any form from any program supported in whole or in part with funds appropriated under this Act
p.000943: shall protect and pro- mote the rights of each resident of the facility, including the right to be free
p.000943: from physical or mental abuse, corporal punish- ment, and any restraints or involuntary seclusions imposed for purposes
p.000943: of discipline or convenience.
p.000943: (2) NONAPPLICABILITY.—Notwithstanding this part, a facil- ity that provides inpatient psychiatric treatment
p.000943: services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and (h)
p.000943: of section 1905 of the Social Secu- rity Act, shall comply with the requirements of part H.
p.000943: (3) APPLICABILITY OF MEDICAID PROVISIONS.—A non-med- ical, community-based facility for children and
p.000943: youth funded under the Medicaid program under title XIX of the Social Secu- rity Act shall continue to meet all
p.000943: existing requirements for participation in such program that are not affected by this part.
p.000943: (b) REQUIREMENTS.—
p.000943: (1) IN GENERAL.—Physical restraints and seclusion may only be imposed on a resident of a facility
p.000943: described in sub- section (a) if—
p.000943: (A) the restraints or seclusion are imposed only in emergency circumstances and only to ensure the imme-
p.000943: diate physical safety of the resident, a staff member, or others and less restrictive interventions have
p.000943: been deter- mined to be ineffective; and
p.000943: (B) the restraints or seclusion are imposed only by an individual trained and certified, by a State-recognized body (as
p.000943: defined in regulation promulgated by the Secretary) and pursuant to a process determined appropriate by
...

p.000945: of restraint and
p.000945: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000945:
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p.000947: 947
p.000947: PUBLIC HEALTH SERVICE ACT
p.000947: Sec. 581
p.000947:
p.000947: seclusion, the process for obtaining approval for continued re- straints and seclusion, procedures to
p.000947: address problematic re- straints, documentation, processing with children, and follow- up with staff, and
p.000947: investigation of injuries and complaints; and
p.000947: (3) that such facilities provide complete and accurate noti- fication of deaths, as required under section 595A(1).
p.000947: (c) ENFORCEMENT.—A State to which this part applies that fails to comply with any requirement of this part,
p.000947: including a fail- ure to provide appropriate training and certification, shall not be eligible for
p.000947: participation in any program supported in whole or in part by funds appropriated under this Act.
p.000947: PART G 22—SERVICES PROVIDED THROUGH RELIGIOUS ORGANIZATIONS 23
p.000947: SEC. 581. ø290kk¿ APPLICABILITY TO DESIGNATED PROGRAMS.
p.000947: (a) DESIGNATED PROGRAMS.—Subject to subsection (b), this part applies to discretionary and formula grant
p.000947: programs adminis- tered by the Substance Abuse and Mental Health Services Admin- istration that make awards of
p.000947: financial assistance to public or pri- vate entities for the purpose of carrying out activities to prevent or treat
p.000947: substance abuse (in this part referred to as a ‘‘designated pro- gram’’). Designated programs include the program under
p.000947: subpart II of part B of title XIX (relating to formula grants to the States).
p.000947: (b) LIMITATION.—This part does not apply to any award of fi- nancial assistance under a designated program
p.000947: for a purpose other than the purpose specified in subsection (a).
p.000947: (c) DEFINITIONS.—For purposes of this part (and subject to sub- section (b)):
p.000947: (1) The term ‘‘designated program’’ has the meaning given such term in subsection (a).
p.000947: (2) The term ‘‘financial assistance’’ means a grant, coopera- tive agreement, or contract.
p.000947: (3) The term ‘‘program beneficiary’’ means an individual who receives program services.
p.000947: (4) The term ‘‘program participant’’ means a public or pri- vate entity that has received financial assistance under a
p.000947: des- ignated program.
p.000947: (5) The term ‘‘program services’’ means treatment for sub- stance abuse, or preventive services regarding such abuse,
p.000947: pro- vided pursuant to an award of financial assistance under a designated program.
p.000947: (6) The term ‘‘religious organization’’ means a nonprofit re- ligious organization.
p.000947:
p.000947:
p.000947:
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p.000947:
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p.000947:
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p.000947: January 30, 2020
p.000947: 22 There are two parts G in this title. The first was added by section 3101 of Public Law 106– 310 (114 Stat. 1168) and
p.000947: relates to projects for children and violence; that part also begins with section 581. See page 669. Sections
p.000947: 3207 and 3208 of such Public Law (114 Stat. 1195, 1197) added parts H and I, respectively.
p.000947: Subsequently, part G above was added by section 144 of the Community Renewal Tax Relief Act of 2000 (as enacted
p.000947: into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A– 619), which provides that title V
p.000947: of this Act ‘‘is amended by adding at the end the following part:’’, thereby placing that part G after the
p.000947: part I added by Public Law 106–310.
p.000947: 23 Section 1955 of this Act also relates to religious organizations as providers of substance abuse
p.000947: services. That section was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.000947: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000947:
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p.000947: Sec. 582 PUBLIC HEALTH SERVICE ACT 948
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p.000947: January 30, 2020
p.000947:
p.000947: SEC. 582. ø290kk–1¿ RELIGIOUS ORGANIZATIONS AS PROGRAM PAR- TICIPANTS.
p.000947: (a) IN GENERAL.—Notwithstanding any other provision of law, a religious organization, on the same basis
p.000947: as any other nonprofit private provider—
p.000947: (1) may receive financial assistance under a designated program; and
p.000947: (2) may be a provider of services under a designated pro- gram.
...

p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000949:
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p.000951: 951
p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
p.000951: (a) IN GENERAL.—The Secretary may make grants to States, units of local government, or tribal governments to
p.000951: establish or ex- pand Sobriety Treatment And Recovery Team (referred to in this section as ‘‘START’’) or other
p.000951: similar programs to determine the ef- fectiveness of pairing social workers or mentors with families that are
p.000951: struggling with a substance use disorder and child abuse or ne- glect in order to help provide peer support,
p.000951: intensive treatment, and child welfare services to such families.
p.000951: (b) ALLOWABLE USES.—A grant awarded under this section may be used for one or more of the following activities:
p.000951: (1) Training eligible staff, including social workers, social services coordinators, child welfare
p.000951: specialists, substance use disorder treatment professionals, and mentors.
p.000951: (2) Expanding access to substance use disorder treatment services and drug testing.
p.000951: (3) Enhancing data sharing with law enforcement agen- cies, child welfare agencies, substance use disorder
p.000951: treatment providers, judges, and court personnel.
p.000951: (4) Program evaluation and technical assistance.
p.000951: (c) PROGRAM REQUIREMENTS.—A State, unit of local govern- ment, or tribal government receiving a grant
p.000951: under this section shall—
p.000951: (1) serve only families for which—
p.000951: (A) there is an open record with the child welfare agency; and
p.000951: (B) substance use disorder was a reason for the record or finding described in paragraph (1); and
p.000951: (2) coordinate any grants awarded under this section with any grant awarded under section 437(f) of the Social
p.000951: Security Act focused on improving outcomes for children affected by substance abuse.
p.000951: (d) TECHNICAL ASSISTANCE.—The Secretary may reserve not more than 5 percent of funds provided under this section
p.000951: to provide technical assistance on the establishment or expansion of programs funded under this section from the
p.000951: National Center on Substance Abuse and Child Welfare.
p.000951: TITLE VI—ASSISTANCE FOR CONSTRUCTION AND MODERN- IZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000951: DECLARATION OF PURPOSE
p.000951: SEC. 600. ø291¿ The purpose of this title is—
p.000951: (a) to assist the several States in the carrying out of their programs for the construction and modernization of such
p.000951: public or other nonprofit community hospitals and other medical fa- cilities as may be necessary, in
p.000951: conjunction with existing facili-
p.000951:
p.000951:
p.000951:
p.000951:
p.000951: January 30, 2020
p.000951: 24 Placement of section 550 is so in law. Section 8214 of Public Law 115-271 inserted a second section 550 at the end
p.000951: of title V.
p.000951: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000951:
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p.000951: Sec. 601 PUBLIC HEALTH SERVICE ACT 952
p.000951:
p.000951: ties, to furnish adequate hospital, clinic, or similar services to all their people;
p.000951: (b) to stimulate the development of new or improved types of physical facilities for medical, diagnostic,
p.000951: preventive, treat- ment, or rehabilitative services; and
p.000951: (c) to promote research, experiments, and demonstrations relating to the effective development and utilization of
p.000951: hospital, clinic, or similar services, facilities, and resources, and to pro- mote the coordination of such
...

p.001023: contracts under paragraph (1), the Secretary shall give preference to any quali- fied applicant for such an award
p.001023: that agrees to expend the award for the purpose of—
p.001023: (A) establishing academic units or programs in fields defined in subsection (a)(1)(A); or
p.001023: (B) substantially expanding such units or programs.
p.001023: (3) PRIORITIES IN MAKING AWARDS.—In awarding grants or contracts under paragraph (1), the Secretary shall give priority
p.001023: to qualified applicants that—
p.001023: (A) proposes a collaborative project between academic administrative units of primary care;
p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001023:
p.001023:
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p.001027: health dentistry. Eligible entities may partner with schools of pub- lic health to permit the education of dental
p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001027:
p.001027:
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
p.001027:
p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
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p.001049: programs to provide education and training to health care pro- fessionals in pain care.
p.001049: (b) CERTAIN TOPICS.—An entity receiving an award under this section shall develop a comprehensive education and
p.001049: training plan that includes information and education on—
p.001049: (1) recognized means for assessing, diagnosing, preventing, treating, and managing pain and related signs and symptoms,
p.001049: including non-addictive medical products and non-pharmaco- logic treatments and the medically appropriate
p.001049: use of con- trolled substances;
p.001049: (2) applicable Federal, State, and local laws, regulations, rules, and policies on controlled substances,
p.001049: including opioids;
p.001049: (3) interdisciplinary approaches to the delivery of pain care, including delivery through specialized
p.001049: centers providing comprehensive pain care treatment expertise, integrated, evi- dence-based pain management,
p.001049: and, as appropriate, non- pharmacotherapy;
p.001049: (4) cultural, linguistic, literacy, geographic, and other bar- riers to care in underserved populations;
p.001049: (5) recent findings, developments, and advancements in pain care research and the provision of pain care,
p.001049: which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and
p.001049: (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which
p.001049: may include best practices related to screening for opioid use disorders, training on screening, brief
p.001049: intervention, and referral to treat-
p.001049: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: PUBLIC HEALTH SERVICE ACT
p.001051: Sec. 760
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p.001051: ment), and safe disposal options for prescription medications (including such options provided by law
p.001051: enforcement or other innovative deactivation mechanisms).
p.001051: (c) EVALUATION OF PROGRAMS.—The Secretary shall (directly or through grants or contracts) provide for
p.001051: the evaluation of pro- grams implemented under subsection (a) in order to determine the effect of such programs on
p.001051: knowledge and practice of pain care.
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p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
p.001053: dis- tribution of mental and substance use disorders services;
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p.001063: private entities in the fields with respect to which the traineeships are awarded.
p.001063: SEC. 770. ø295e¿ AUTHORIZATION OF APPROPRIATIONS.
p.001063: (a) IN GENERAL.—For the purpose of carrying out this subpart, there is authorized to be appropriated $43,000,000
p.001063: for fiscal year
p.001063: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001063: Sec. 775 PUBLIC HEALTH SERVICE ACT 1064
p.001063:
p.001063: 2011, and such sums as may be necessary for each of the fiscal years 2012 through 2015.
p.001063: (b) LIMITATION REGARDING CERTAIN PROGRAM.—In obligating amounts appropriated under subsection (a), the
p.001063: Secretary may not obligate more than 30 percent for carrying out section 767.
p.001063: Subpart 3—Recruitment and Retention Programs
p.001063:
p.001063: SEC. 775. ø295f¿ INVESTMENT IN TOMORROW’S PEDIATRIC HEALTH CARE WORKFORCE.
p.001063: (a) ESTABLISHMENT.—The Secretary shall establish and carry out a pediatric specialty loan repayment program under
p.001063: which the eligible individual agrees to be employed full-time for a specified period (which shall not be less
p.001063: than 2 years) in providing pediatric medical subspecialty, pediatric surgical specialty, or child and ado- lescent
p.001063: mental and behavioral health care, including substance abuse prevention and treatment services.
p.001063: (b) PROGRAM ADMINISTRATION.—Through the program estab- lished under this section, the Secretary shall enter
p.001063: into contracts with qualified health professionals under which—
p.001063: (1) such qualified health professionals will agree to provide pediatric medical subspecialty, pediatric surgical
p.001063: specialty, or child and adolescent mental and behavioral health care in an area with a shortage of the
p.001063: specified pediatric subspecialty that has a sufficient pediatric population to support such pediatric
p.001063: subspecialty, as determined by the Secretary; and
p.001063: (2) the Secretary agrees to make payments on the prin- cipal and interest of undergraduate, graduate, or
p.001063: graduate medical education loans of professionals described in para- graph (1) of not more than $35,000
p.001063: a year for each year of agreed upon service under such paragraph for a period of not more than 3
p.001063: years during the qualified health professional’s—
p.001063: (A) participation in an accredited pediatric medical subspecialty, pediatric surgical specialty, or child and
p.001063: ado- lescent mental health subspecialty residency or fellowship; or
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p.001063: (B) employment as a pediatric medical subspecialist, pediatric surgical specialist, or child and adolescent
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p.001065: PUBLIC HEALTH SERVICE ACT
p.001065: Sec. 776
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p.001065: (B) CHILD AND ADOLESCENT MENTAL AND BEHAVIORAL HEALTH.—For purposes of contracts with respect to child and
p.001065: adolescent mental and behavioral health care, the term ‘‘qualified health professional’’ means a health
p.001065: care professional who—
p.001065: (i) has received specialized training or clinical ex- perience in child and adolescent mental health in psy-
p.001065: chiatry, psychology, school psychology, behavioral pe- diatrics, psychiatric nursing, social work, school social
p.001065: work, substance abuse disorder prevention and treat- ment, marriage and family therapy, school counseling, or
p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
p.001065: (1) are or will be working in a school or other pre-kinder- garten, elementary, or secondary education
p.001065: setting;
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p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: 1083
p.001083: PUBLIC HEALTH SERVICE ACT
p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
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p.001083: 26 Effective on July 1, 2015, section 512(z)(3) of Public Law 113–128 provides for an amend- ment to
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p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001123: Sec. 917 PUBLIC HEALTH SERVICE ACT 1124
p.001123:
p.001123: the victims referred to in paragraph (1), and of other appro- priate public and private entities
p.001123: (including medical societies, victim services organizations, sexual assault prevention organi- zations, and social
p.001123: services organizations).
p.001123: SEC. 917. ø299b–6¿ COORDINATION OF FEDERAL GOVERNMENT QUAL- ITY IMPROVEMENT EFFORTS.
p.001123: (a) REQUIREMENT.—
p.001123: (1) IN GENERAL.—To avoid duplication and ensure that Federal resources are used efficiently and
p.001123: effectively, the Sec- retary, acting through the Director, shall coordinate all re- search, evaluations, and
p.001123: demonstrations related to health serv- ices research, quality measurement and quality improvement activities
p.001123: undertaken and supported by the Federal Govern- ment.
p.001123: (2) SPECIFIC ACTIVITIES.—The Director, in collaboration with the appropriate Federal officials
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p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
p.001197: (D) develop best practices in areas such as family or consumer support, return to work, housing or
p.001197: supportive living personal assistance services, assistive technology and devices, behavioral health
p.001197: services, substance abuse services, and traumatic brain injury treatment and reha- bilitation;
p.001197: (E) tailor existing State or American Indian consor- tium systems to provide accommodations to the needs
p.001197: of individuals with traumatic brain injury (including systems administered by the State or American Indian
p.001197: consortium departments responsible for health, mental health, labor/ employment, education, intellectual
p.001197: disabilities or develop- mental disorders, transportation, and correctional sys- tems);
p.001197: (F) improve data sets coordinated across systems and other needs identified by a State or American
p.001197: Indian con- sortium plan supported by its advisory council; and
p.001197: (G) develop capacity within targeted communities.
p.001197: (f) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.001197: coordinated as appropriate
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
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p.001201: develop a flexible training module—
p.001201: (i) for supporting activities under subsection (c);
p.001201: and
p.001201: (ii) that adapts to changing needs, settings, health
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p.001201: care providers, and social service providers;
p.001201: (B) providing technical assistance to grantees related to implementing activities described in subsection
p.001201: (c) and reporting on any best practices identified by the grantees;
p.001201: (C) developing a reliable methodology for collecting data, and reporting such data, on the number of
p.001201: human trafficking victims identified and served by grantees in a manner that, at a minimum, prevents
p.001201: disclosure of indi- vidually identifiable information consistent with all appli- cable privacy laws and
p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001201:
p.001201:
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p.001219: owns or controls a health maintenance organization shall provide satisfactory assurances that it will assume
p.001219: the financial obligations of the health maintenance organization.
p.001219: (d) An organization that offers health benefits coverage shall not be considered as failing to meet the
p.001219: requirements of this sec- tion notwithstanding that it provides, with respect to coverage of- fered in
p.001219: connection with a group health plan in the small or large group market (as defined in section 2791(e)), an
p.001219: affiliation period consistent with the provisions of section 2701(g).
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001219:
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p.001269: (4) develop (A) methods by which the cost and effectiveness of activities respecting health information and
p.001269: health pro- motion, preventive health services, and education in the appro- priate use of health care, can be
p.001269: measured, including methods for evaluating the effectiveness of various settings for such ac- tivities and the various
p.001269: types of persons engaged in such activi- ties, (B) methods for reimbursement or payment for such ac- tivities,
p.001269: and (C) models and standards for the conduct of such activities, including models and standards for the
p.001269: education, by providers of institutional health services, of individuals receiv- ing such services respecting the
p.001269: nature of the institutional health services provided the individuals and the symptoms, signs, or diagnoses
p.001269: which led to provision of such services;
p.001269: (5) develop a method for assessing the cost and effective- ness of specific medical services and procedures
p.001269: under various conditions of use, including the assessment of the sensitivity and specificity of screening and
p.001269: diagnostic procedures; and
p.001269: (6) enumerate and assess, using methods developed under paragraph (5), preventive health measures and services
p.001269: with respect to their cost and effectiveness under various conditions of use (which measures and services may
p.001269: include blood pres- sure screening, cholesterol screening and control, smoking ces- sation programs, substance
p.001269: abuse programs, cancer screening, dietary and nutritional counseling, diabetes screening and edu- cation,
p.001269: intraocular pressure screening, and stress manage- ment).
p.001269: (b) The Secretary shall make a periodic survey of the needs, in- terest, attitudes, knowledge, and behavior of
p.001269: the American public regarding health and health care. The Secretary shall take into consideration the
p.001269: findings of such surveys and the findings of simi- lar surveys conducted by national and community health education
p.001269: organizations, and other organizations and agencies for formulating policy respecting health information and health
p.001269: promotion, preven- tive health services, and education in the appropriate use of health care.
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p.001269: January 30, 2020
p.001269:
p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
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p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
p.001271: dis- eases; and shall be designed to reach populations of different languages and of different social and
p.001271: economic backgrounds.
p.001271: (2) Securing the cooperation of the communication media, providers of health care, schools, and others in
p.001271: activities de- signed to promote and encourage the use of health maintaining information and behavior.
p.001271: (3) The study of health information and promotion in ad- vertising and the making to concerned Federal
p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others of information for use by the public respecting health in- surance policies and prepaid health plans,
p.001271: including informa- tion on the benefits provided by the various types of such poli- cies and plans, the premium
p.001271: charges for such policies and plans, exclusions from coverage or eligibility for coverage, cost sharing
p.001271: requirements, and the ratio of the amounts paid as benefits to the amounts received as premiums and information
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p.001277: Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics.
p.001277: (2) The term ‘‘Hispanic’’ means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or
p.001277: any other Spanish-speaking country.
p.001277: (h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001277: to be appropriated such sums as may be necessary for each of fiscal years 2011 through 2016.
p.001277: SEC. 1707A. ø300u–6a¿ INDIVIDUAL OFFICES OF MINORITY HEALTH WITHIN THE DEPARTMENT.
p.001277: (a) IN GENERAL.—The head of each agency specified in sub- section (b)(1) shall establish within the
p.001277: agency an office to be known as the Office of Minority Health. The head of each such Of- fice shall be appointed by
p.001277: the head of the agency within which the Office is established, and shall report directly to the head of the
p.001277: agency. The head of such agency shall carry out this section (as this section relates to the agency) acting
p.001277: through such Director.
p.001277: (b) SPECIFIED AGENCIES.—The agencies referred to in sub- section (a) are the Centers for Disease Control and
p.001277: Prevention, the Health Resources and Services Administration, the Substance Abuse and Mental Health
p.001277: Services Administration, the Agency for Healthcare Research and Quality, the Food and Drug Administra-
p.001277: tion, and the Centers for Medicare & Medicaid Services.
p.001277: (c) DIRECTOR; APPOINTMENT.—Each Office of Minority Health established in an agency listed in subsection (a) shall
p.001277: be headed by a director, with documented experience and expertise in minority health services research and
p.001277: health disparities elimination.
p.001277: (d) REFERENCES.—Except as otherwise specified, any reference in Federal law to an Office of Minority Health (in the
p.001277: Department of Health and Human Services) is deemed to be a reference to the Office of Minority Health in the Office of
p.001277: the Secretary.
p.001277: (e) FUNDING.—
p.001277: (1) ALLOCATIONS.—Of the amounts appropriated for a spec- ified agency for a fiscal year, the Secretary must designate
p.001277: an appropriate amount of funds for the purpose of carrying out ac- tivities under this section through the minority
p.001277: health office of the agency. In reserving an amount under the preceding sen- tence for a minority health
p.001277: office for a fiscal year, the Sec- retary shall reduce, by substantially the same percentage, the amount
p.001277: that otherwise would be available for each of the pro- grams of the designated agency involved.
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p.001295: will provide significant benefits through the collection, analysis, and dissemination of information or data
p.001295: which will be useful to States in which grants under such subsection have not been made.
p.001295: (c) For purposes of this section—
p.001295: (1) the term ‘‘school of medicine’’ has the same meaning as in section 701(4); and
p.001295: (2) the term ‘‘accredited’’ has the same meaning as in sec- tion 701(5).
p.001295: (d) To carry out this section, there are authorized to be appro- priated $2,000,000 for fiscal year 1985 and for each
p.001295: of the two suc- ceeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000
p.001295: for each of the fiscal years 1991 and 1992, such sums as may be necessary for each of the fiscal
p.001295: years 1993 through 2005, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
p.001295: for fiscal year 2012, $28,940,625
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001295: Sec. 1911 PUBLIC HEALTH SERVICE ACT 1296
p.001295:
p.001295: for fiscal year 2013, $30,387,656 for fiscal year 2014, $20,213,000 for each of fiscal years 2015
p.001295: through 2019, and $22,334,000 for each of fiscal years 2020 through 2024.
p.001295: PART B—BLOCK GRANTS REGARDING MENTAL HEALTH AND
p.001295: SUBSTANCE ABUSE
p.001295:
p.001295: Subpart I—Block Grants for Community Mental Health Services
p.001295: SEC. 1911. ø300x¿ FORMULA GRANTS TO STATES.
p.001295: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Director of the
p.001295: Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined
p.001295: in accordance with section 1918. The Secretary shall make a grant to the State of the allotment made
p.001295: for the State for the fiscal year if the State submits to the Secretary an application in accordance with
p.001295: section 1917.
p.001295: (b) PURPOSE OF GRANTS.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001295: 1916, the State in- volved will expend the grant only for the purpose of—
p.001295: (1) providing community mental health services for adults with a serious mental illness and children with a serious
p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
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p.001305: Commerce; divided by
p.001305: (II) the factor determined under paragraph (8) for the District.
p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
p.001305: in clause (ii) for the District of Columbia.
p.001305: (7) DETERMINATION OF TERM ‘‘P%’’.—For purposes of para- graph (4), the term ‘‘P%’’ means the percentage
p.001305: constituted by the ratio of the term ‘‘P’’ determined under paragraph (5) for the State involved to the sum
p.001305: of the respective terms ‘‘P’’ deter- mined for the States.
p.001305: (8) DETERMINATION OF CERTAIN FACTOR.—
p.001305: (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to
p.001305: adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under
p.001305: each of sub- paragraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist
p.001305: between the State and other States in the costs of providing comprehensive community mental health services to
p.001305: adults with a serious mental ill- ness and to children with a serious emotional disturbance.
p.001305: (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year
p.001305: in- volved shall be determined according to the methodology described in the report entitled ‘‘Adjusting
p.001305: the Alcohol, Drug Abuse and Mental Health Services Block Grant Allo- cations for Poverty Populations and Cost of
p.001305: Service’’, dated March 30, 1990, and prepared by Health Economics Re- search, a corporation, pursuant to a
p.001305: contract with the Na- tional Institute on Drug Abuse.
p.001305: (C) The factor determined under this paragraph for the State involved may not for any fiscal year be
p.001305: greater than 1.1 or less than 0.9.
p.001305: (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General,
p.001305: shall in accordance with this section make a determination for each State of the factor that is to be in effect
p.001305: for the State under this paragraph. The factor so determined shall re- main in effect through fiscal year 1994,
p.001305: and shall be recal- culated every third fiscal year thereafter.
p.001305: (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the
p.001305: Federal Register, periodically make such refinements in the meth- odology referred to in subparagraph (B) as are
p.001305: consistent with the purpose described in subparagraph (A).
p.001305: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001307: 1307
p.001307: PUBLIC HEALTH SERVICE ACT
p.001307: Sec. 1919
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p.001307: purposes speci- fied in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts
p.001307: appropriated under subsection (a) for a fiscal year.
p.001307: (2) DATA COLLECTION.—The purpose specified in this para- graph is carrying out sections 505(c) and 1971 with
p.001307: respect to mental health.
p.001307: (3) PROGRAM EVALUATION.—The purpose specified in this paragraph is the conduct of evaluations of
p.001307: prevention and treatment programs and services with respect to mental health to determine methods for improving
p.001307: the availability and qual- ity of such programs and services.
p.001307: (c) EARLY SERIOUS MENTAL ILLNESS.—
p.001307: (1) IN GENERAL.—Except as provided in paragraph (2), a State shall expend not less than 10 percent of the
p.001307: amount the State receives for carrying out this section for each fiscal year to support evidence-based programs
p.001307: that address the needs of individuals with early serious mental illness, including psy- chotic disorders,
p.001307: regardless of the age of the individual at onset.
p.001307: (2) STATE FLEXIBILITY.—In lieu of expending 10 percent of the amount the State receives under this section for
p.001307: a fiscal year as required under paragraph (1), a State may elect to ex- pend not less than 20 percent of such
p.001307: amount by the end of such succeeding fiscal year.
p.001307:
p.001307: Subpart II—Block Grants for Prevention and Treatment of Substance Abuse
p.001307:
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p.001307: January 30, 2020
p.001307: SEC. 1921. ø300x–21¿ FORMULA GRANTS TO STATES.
p.001307: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Center for
p.001307: Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an amount determined in
p.001307: accordance with section 1933. The Sec- retary shall make a grant to the State of the allotment made for the
p.001307: State for the fiscal year if the State submits to the Secretary an application in accordance with section
p.001307: 1932.
p.001307: (b) AUTHORIZED ACTIVITIES.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001307: 1931, the State in- volved will expend the grant only for the purpose of carrying out the plan developed
p.001307: in accordance with section 1932(b) and for plan- ning, carrying out, and evaluating activities to prevent and
p.001307: treat substance use disorders and for related activities authorized in sec- tion 1924.
p.001307: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001309: 1309
p.001309: PUBLIC HEALTH SERVICE ACT
p.001309: Sec. 1922
p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
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p.001309: graph, as indicated by a comparison of the number of such women seeking the services with the availability in
p.001309: the State of the services.
p.001309: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001309: 120 days after the date on which the request is made.
p.001309: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001309: in- volved.
p.001309: (3) CHILDCARE AND PRENATAL CARE.—A funding agreement for a grant under section 1921 for a State is that
p.001309: each entity providing treatment services with amounts reserved under paragraph (1) by the State will,
p.001309: directly or through arrange- ments with other public or nonprofit private entities, make available
p.001309: prenatal care to women receiving such services and, while the women are receiving the services, childcare.
p.001309: SEC. 1923. ø300x–23¿ INTRAVENOUS SUBSTANCE ABUSE.
p.001309: (a) CAPACITY OF TREATMENT PROGRAMS.—
p.001309: (1) NOTIFICATION OF REACHING CAPACITY.—A funding agreement for a grant under section 1921 is that the
p.001309: State in- volved will, in the case of programs of treatment for intra- venous drug abuse, require that
p.001309: any such program receiving amounts from the grant, upon reaching 90 percent of its capac- ity to admit
p.001309: individuals to the program, provide to the State a notification of such fact.
p.001309: (2) PROVISION OF TREATMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001309: will, with respect to notifications under paragraph (1), ensure that each individual who requests and is
p.001309: in need of treatment for intra- venous drug abuse is admitted to a program of such treatment not later than—
p.001309: (A) 14 days after making the request for admission to such a program; or
p.001309: (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on
p.001309: the date of such request and if interim services are made available to the individual not later than 48
p.001309: hours after such request.
p.001309: (b) OUTREACH TO PERSONS WHO INJECT DRUGS.—A funding agreement for a grant under section 1921 is
p.001309: that the State in- volved, in providing amounts from the grant to any entity for treat- ment services for persons
p.001309: who inject drugs, will require the entity to carry out activities to encourage individuals in need of
p.001309: such treatment to undergo treatment.
p.001309: SEC. 1924. ø300x–24¿ REQUIREMENTS REGARDING TUBERCULOSIS AND HUMAN IMMUNODEFICIENCY VIRUS.
p.001309: (a) TUBERCULOSIS.—
p.001309: (1) IN GENERAL.—A funding agreement for a grant under section 1921 is that the State involved will
p.001309: require that any entity receiving amounts from the grant for operating a pro- gram of treatment for
p.001309: substance use disorders—
p.001309: (A) will, directly or through arrangements with other public or nonprofit private entities, routinely make
p.001309: avail-
p.001309: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001311: 1311
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p.001313: agreements re- quired in this section, subject to paragraph (2).
p.001313: (2) LIMITATION.—A funding agreement for a grant under section 1921 for a State is that the grant will not be
p.001313: expended to make payment for any service provided for purposes of com- pliance with this section to the extent
p.001313: that payment has been made, or can reasonably be expected to be made, with respect to such service—
p.001313: (A) under any State compensation program, under any insurance policy, or under any Federal or State health
p.001313: benefits program (including the program established in title XVIII of the Social Security Act and the
p.001313: program es- tablished in title XIX of such Act); or
p.001313: (B) by an entity that provides health services on a pre- paid basis.
p.001313: (d) APPLICABILITY OF CERTAIN PROVISION.—Section 1931 ap- plies to this section (and to each other
p.001313: provision of this subpart).
p.001313: SEC. 1925. ø300x–25¿ GROUP HOMES FOR PERSONS IN RECOVERY FROM SUBSTANCE USE DISORDERS.
p.001313: (a) STATE REVOLVING FUNDS FOR ESTABLISHMENT OF HOMES.— A State, using funds available under section 1921,
p.001313: may establish and maintain the ongoing operation of a revolving fund in accord- ance with this section to
p.001313: support group homes for persons in recov- ery from substance use disorders as follows:
p.001313: (1) The purpose of the fund is to make loans for the costs of establishing programs for the provision of housing in
p.001313: which individuals recovering from alcohol or drug abuse may reside in groups of not less than 6
p.001313: individuals. The fund is estab- lished directly by the State or through the provision of a grant or contract to a
p.001313: nonprofit private entity.
p.001313: (2) The programs are carried out in accordance with guide- lines issued under subsection (b).
p.001313: (3) Not less than $100,000 is available for the fund.
p.001313: (4) Loans made from the revolving fund do not exceed
p.001313: $4,000 and each such loan is repaid to the revolving fund by the residents of the housing involved not
p.001313: later than 2 years after the date on which the loan is made.
p.001313: (5) Each such loan is repaid by such residents through monthly installments, and a reasonable penalty is
p.001313: assessed for each failure to pay such periodic installments by the date spec- ified in the loan agreement involved.
p.001313: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001313:
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p.001313:
p.001313: Sec. 1926 PUBLIC HEALTH SERVICE ACT 1314
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p.001315: 1315
p.001315: PUBLIC HEALTH SERVICE ACT
p.001315: Sec. 1926
p.001315:
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p.001315:
p.001315: January 30, 2020
p.001315: (i) certifies to the Secretary by May 1 of the fiscal year for which the funds are appropriated, consistent with
p.001315: subparagraph (B), that the State will commit ad- ditional State funds, in accordance with paragraph (1), to ensure that
p.001315: retailers do not sell tobacco products to individuals under 21 years of age;
p.001315: (ii) agrees to comply with a negotiated agreement for a corrective action plan that is approved by the
p.001315: Secretary and carried out in accordance with guide- lines issued by the Secretary; or
p.001315: (iii) is a territory that receives less than
p.001315: $1,000,000 for a fiscal year under section 1921.
p.001315: (B) CERTIFICATION.—
p.001315: (i) IN GENERAL.—The amount of funds to be com- mitted by a State pursuant to subparagraph (A)(i) shall
p.001315: be equal to 1 percent of such State’s substance abuse allocation determined under section 1933 for each
p.001315: percentage point by which the State misses the retailer compliance rate goal established by the Sec-
p.001315: retary.
p.001315: (ii) STATE EXPENDITURES.—For a fiscal year in which a State commits funds as described in clause (i), such State
p.001315: shall maintain State expenditures for to- bacco prevention programs and for compliance activi- ties at a
p.001315: level that is not less than the level of such expenditures maintained by the State for the pre- ceding
p.001315: fiscal year, plus the additional funds for tobacco compliance activities required under clause (i). The State
p.001315: shall submit a report to the Secretary on all State obligations of funds for such fiscal year and all
p.001315: State expenditures for the preceding fiscal year for to- bacco prevention and compliance activities by program activity
p.001315: by July 31 of such fiscal year.
p.001315: (iii) DISCRETION.—The Secretary shall exercise discretion in enforcing the timing of the State obliga-
p.001315: tion of the additional funds required by the certifi- cation described in subparagraph (A)(i) as late as July
p.001315: 31 of such fiscal year.
p.001315: (C) FAILURE TO CERTIFY.—If a State described in sub- paragraph (A) fails to certify to the Secretary pursuant
p.001315: to subparagraph (A)(i) or enter into, or comply with, a nego- tiated agreement under subparagraph (A)(ii), the
p.001315: Secretary may take action pursuant to paragraph (1).
p.001315: (c) IMPLEMENTATION OF REPORTING REQUIREMENTS.—
p.001315: (1) TRANSITION PERIOD.—The Secretary shall—
p.001315: (A) not withhold amounts under subsection (b) for the 3-year period immediately following the date of enactment of
p.001315: division N of the Further Consolidated Appropriations Act, 2020; and
...

p.001319:
p.001319:
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p.001319:
p.001319: January 30, 2020
p.001319:
p.001319: pose of providing treatment services in penal or correctional in- stitutions of the State, the State will not expend
p.001319: more than an amount equal to the amount expended for such purpose by the State from the grant made under section
p.001319: 1912A to the State for fiscal year 1991 (as section 1912A was in effect for such fis- cal year).
p.001319: (b) EXCEPTION REGARDING INPATIENT HOSPITAL SERVICES.—
p.001319: (1) MEDICAL NECESSITY AS PRECONDITION.—With respect to compliance with the agreement made under subsection
p.001319: (a), a State may expend a grant under section 1921 to provide inpa- tient hospital services as treatment for substance
p.001319: use disorders only if it has been determined, in accordance with guidelines issued by the Secretary, that
p.001319: such treatment is a medical ne- cessity for the individual involved, and that the individual can- not be
p.001319: effectively treated in a community-based, nonhospital, residential program of treatment.
p.001319: (2) RATE OF PAYMENT.—In the case of an individual for whom a grant under section 1921 is expended to provide
p.001319: inpa- tient hospital services described in paragraph (1), a funding agreement for the grant for the State
p.001319: involved is that the daily rate of payment provided to the hospital for providing the serv- ices to the individual will
p.001319: not exceed the comparable daily rate provided for community-based, nonhospital, residential pro- grams of
p.001319: treatment for substance abuse.
p.001319: (c) WAIVER REGARDING CONSTRUCTION OF FACILITIES.—
p.001319: (1) IN GENERAL.—The Secretary may provide to any State a waiver of the restriction established in
p.001319: subsection (a)(1)(C) for the purpose of authorizing the State to expend a grant under section 1921 for the
p.001319: construction of a new facility or re- habilitation of an existing facility, but not for land acquisition.
p.001319: (2) STANDARD REGARDING NEED FOR WAIVER.—The Sec- retary may approve a waiver under paragraph (1) only
p.001319: if the State demonstrates to the Secretary that adequate treatment cannot be provided through the use of
p.001319: existing facilities and that alternative facilities in existing suitable buildings are not available.
p.001319: (3) AMOUNT.—In granting a waiver under paragraph (1), the Secretary shall allow the use of a specified amount of
p.001319: funds to construct or rehabilitate a specified number of beds for resi- dential treatment and a specified number
p.001319: of slots for out- patient treatment, based on reasonable estimates by the State of the costs of construction or
p.001319: rehabilitation. In considering waiver applications, the Secretary shall ensure that the State has carefully
p.001319: designed a program that will minimize the costs of additional beds.
p.001319: (4) MATCHING FUNDS.—The Secretary may grant a waiver under paragraph (1) only if the State agrees, with
p.001319: respect to the costs to be incurred by the State in carrying out the pur- pose of the waiver, to make
p.001319: available non-Federal contribu- tions in cash toward such costs in an amount equal to not less than $1 for each
p.001319: $1 of Federal funds provided under section 1921.
...

p.001321: (2) MODIFICATIONS.—
p.001321: (A) AUTHORITY OF SECRETARY.—As a condition; 9 of making a grant under section 1921 to a State for a
p.001321: fiscal year, the Secretary may require that the State modify any provision of the plan submitted by the State
p.001321: under sub- section (a)(6) (including provisions on priorities in carrying out authorized activities). If the
p.001321: Secretary approves the plan and makes the grant to the State for the fiscal year, the Secretary may not
p.001321: during such year require the State to modify the plan.
p.001321: (B) STATE REQUEST FOR MODIFICATION.—If the State determines that a modification to such plan is
p.001321: necessary, the State may request the Secretary to approve the modi- fication. Any such modification shall be
p.001321: in accordance with paragraph (1) and section 1941.
p.001321:
p.001321:
p.001321:
p.001321:
p.001321: January 30, 2020
p.001321: 9 The semicolon after ‘‘a condition’’ in paragraph (2)(A) probably should not appear. See amendment made by
p.001321: section 8002(i)(2)(B)(ii) of Public Law 114–255.
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
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p.001323: 1323
p.001323: PUBLIC HEALTH SERVICE ACT
p.001323: Sec. 1933
p.001323:
p.001323: (3) AUTHORITY OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—With respect to plans submitted by the States
p.001323: under subsection (a)(6), including any modification under paragraph (2), the Secretary, acting through the
p.001323: Director of the Center for Substance Abuse Prevention, shall review and approve or dis- approve the
p.001323: provisions of the plans that relate to prevention activities.
p.001323: (c) WAIVERS REGARDING CERTAIN TERRITORIES.—In the case of any territory of the United States except Puerto Rico, the
p.001323: Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be
p.001323: appropriate, other than the provisions of section 1931.
p.001323: (d) ISSUANCE OF REGULATIONS; PRECONDITION TO MAKING GRANTS.—
p.001323: (1) REGULATIONS.—Not later than August 25, 1992, the Secretary, acting as appropriate through the Director
p.001323: of the Center for Treatment Improvement or the Director of the Cen- ter for Substance Abuse Prevention, shall by
p.001323: regulation estab- lish standards specifying the circumstances in which the Sec- retary will consider an
p.001323: application for a grant under section 1921 to be in accordance with this section.
p.001323: (2) ISSUANCE AS PRECONDITION TO MAKING GRANTS.—The Secretary may not make payments under any grant under
p.001323: sec- tion 1921 for fiscal year 1993 on or after January 1, 1993, un- less the Secretary has issued standards
p.001323: under paragraph (1).
p.001323: (e) WAIVER AUTHORITY FOR CERTAIN REQUIREMENTS.—
p.001323: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may waive the requirements of all or part
p.001323: of the sec- tions described in paragraph (2) using objective criteria estab- lished by the Secretary by
p.001323: regulation after consultation with the States and other interested parties including consumers and providers.
p.001323: (2) SECTIONS.—The sections described in paragraph (1) are sections 1922(b) 10, 1923, 1924 and 1928.
p.001323: (3) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001323: under para- graph (1) and inform the State of that decision not later than 120 days after the date on which
p.001323: the request and all the infor- mation needed to support the request are submitted.
p.001323: (4) ANNUAL REPORTING REQUIREMENT.—The Secretary shall annually report to the general public on the
p.001323: States that receive a waiver under this subsection.
p.001323: SEC. 1933. ø300x–33¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
p.001323: (a) STATES.—
p.001323: (1) IN GENERAL.—Subject to subsection (b), the Secretary shall determine the amount of the allotment
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p.001325: oc- curring during the ensuing period in the population of all terri- tories with respect to which recent such data do
p.001325: exist.
p.001325: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001325:
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p.001325: Sec. 1934 PUBLIC HEALTH SERVICE ACT 1326
p.001325:
p.001325: (5) APPLICABILITY OF CERTAIN PROVISIONS.—For purposes of subsections (a) and (b), the term ‘‘State’’ does not
p.001325: include the territories of the United States.
p.001325: (d) INDIAN TRIBES AND TRIBAL ORGANIZATIONS.—
p.001325: (1) IN GENERAL.—If the Secretary—
p.001325: (A) receives a request from the governing body of an Indian tribe or tribal organization within any
p.001325: State that funds under this subpart be provided directly by the Sec- retary to such tribe or organization;
p.001325: and
p.001325: (B) makes a determination that the members of such tribe or tribal organization would be better served
p.001325: by means of grants made directly by the Secretary under this; 11
p.001325: the Secretary shall reserve from the allotment under section 1921 for the State for the fiscal year involved an
p.001325: amount that bears the same ratio to the allotment as the amount provided under this subpart to the tribe or
p.001325: tribal organization for fiscal year 1991 for activities relating to the prevention and treat- ment of the
p.001325: abuse of alcohol and other drugs bore to the amount of the portion of the allotment under this subpart
p.001325: for the State for such fiscal year that was expended for such ac- tivities.
p.001325: (2) TRIBE OR TRIBAL ORGANIZATION AS GRANTEE.—The amount reserved by the Secretary on the basis of a
p.001325: determina- tion under this paragraph 12 shall be granted to the Indian tribe or tribal organization
p.001325: serving the individuals for whom such a determination has been made.
p.001325: (3) APPLICATION.—In order for an Indian tribe or tribal or- ganization to be eligible for a grant for a fiscal year
p.001325: under this paragraph, it shall submit to the Secretary a plan for such fis- cal year that meets such criteria as
p.001325: the Secretary may pre- scribe.
p.001325: (4) DEFINITION.—The terms ‘‘Indian tribe’’ and ‘‘tribal orga- nization’’ have the same meaning given such terms
p.001325: in sub- sections (b) and (c) of section 4 of the Indian Self-Determina- tion and Education Assistance Act.
p.001325: SEC. 1934. ø300x–34¿ DEFINITIONS.
p.001325: For purposes of this subpart:
p.001325: (1) The term ‘‘authorized activities’’, subject to section 1931, means the activities described in
p.001325: section 1921(b).
p.001325: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1921 to a State, means that the
p.001325: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001325: (3) The term ‘‘prevention activities’’, subject to section 1931, means activities to prevent substance
p.001325: use disorders.
p.001325: (4) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.001325:
p.001325:
p.001325:
p.001325:
p.001325:
p.001325: January 30, 2020
p.001325: 11 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘under this subpart’’.
p.001325: 12 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘sub- section’’.
p.001325: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001325:
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p.001327: 1327
p.001327: PUBLIC HEALTH SERVICE ACT
p.001327: Sec. 1941
p.001327:
p.001327: (5) The term ‘‘treatment activities’’ means treatment serv- ices and, subject to section 1931, authorized activities
p.001327: that are related to treatment services.
p.001327: (6) The term ‘‘treatment facility’’ means an entity that pro- vides treatment services.
p.001327: (7) The term ‘‘treatment services’’, subject to section 1931, means treatment for substance use disorders.
p.001327: SEC. 1935. ø300x–35¿ FUNDING.
p.001327: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this subpart, subpart III and
p.001327: section 505(d) with re- spect to substance abuse, and section 515(d), there are authorized to be
p.001327: appropriated $1,858,079,000 for each of fiscal years 2018 through 2022.. 13
p.001327: (b) ALLOCATIONS FOR TECHNICAL ASSISTANCE, NATIONAL DATA BASE, DATA COLLECTION, AND PROGRAM EVALUATIONS.—
p.001327: (1) IN GENERAL.—
p.001327: (A) For the purpose of carrying out section 1948(a) with respect to substance abuse, section 515(d), and
p.001327: the purposes specified in subparagraphs (B) and (C), the Sec- retary shall obligate 5 percent of
p.001327: the amounts appro- priated under subsection (a) each fiscal year.
p.001327: (B) The purpose specified in this subparagraph is the collection of data in this paragraph 14 is
p.001327: carrying out sec- tions 505(d) and 1971 with respect to substance abuse.
p.001327: (C) The purpose specified in this subparagraph is the conduct of evaluations of authorized activities to
p.001327: determine methods for improving the availability and quality of such activities.
p.001327: (2) ACTIVITIES OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—Of the amounts reserved under paragraph (1) for a
p.001327: fis- cal year, the Secretary, acting through the Director of the Cen- ter for Substance Abuse Prevention, shall
p.001327: obligate 20 percent for carrying out paragraph (1)(C), section 1948(a) with respect to prevention activities, and
p.001327: section 515(d).
p.001327: (3) CORE DATA SET.—A State that receives a new grant, contract, or cooperative agreement from amounts
p.001327: available to the Secretary under paragraph (1), for the purposes of improv- ing the data collection, analysis and
p.001327: reporting capabilities of the State, shall be required, as a condition of receipt of funds, to collect, analyze,
p.001327: and report to the Secretary for each fiscal year subsequent to receiving such funds a core data set to
p.001327: be determined by the Secretary in conjunction with the States.
p.001327: Subpart III—General Provisions
p.001327:
p.001327: SEC. 1941. ø300x–51¿ OPPORTUNITY FOR PUBLIC COMMENT ON STATE PLANS.
p.001327: A funding agreement for a grant under section 1911 or 1921 is that the State involved will make the
p.001327: plan required in section
p.001327:
p.001327:
p.001327:
p.001327:
p.001327:
p.001327: January 30, 2020
p.001327: 13 Two periods at the end of subsection (a) is so in law. See amendment made by section 8002(k)(1)(B)
p.001327: of Public Law 114–255.
p.001327: 14 So in law. See section 202 of Public Law 102–321 (106 Stat. 403). The words ‘‘the collection of data in this
p.001327: paragraph’’ probably should not appear.
p.001327: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001327:
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p.001331: Secretary shall reduce the amount of payments under the program in-
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
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p.001333: 1333
p.001333: PUBLIC HEALTH SERVICE ACT
p.001333: Sec. 1950
p.001333:
p.001333: volved to the State by an amount equal to the costs of detailing personnel and the fair market value of any
p.001333: supplies, equip- ment, or services provided by the Secretary. The Secretary shall, for the payment of
p.001333: expenses incurred in complying with such request, expend the amounts withheld.
p.001333: SEC. 1949. 15 ø300x–59¿ PLANS FOR PERFORMANCE PARTNERSHIPS.
p.001333: (a) DEVELOPMENT.—The Secretary in conjunction with States and other interested groups shall develop
p.001333: separate plans for the programs authorized under subparts I and II for creating more flexibility for States
p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
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p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001333: allotted to such State under section 1921, an amount equal to the proportion of Native Hawaiians residing
p.001333: in the State to the total population of the State shall be available, respectively, for carrying out the
p.001333: program in- volved for Native Hawaiians.
p.001333: (b) EXPENDITURE OF AMOUNTS.—The amount made available under subsection (a) may be expended only through
p.001333: contracts en- tered into by the State of Hawaii with public and private nonprofit organizations to enable such
p.001333: organizations to plan, conduct, and administer comprehensive substance use disorder and treatment programs
p.001333: for the benefit of Native Hawaiians. In entering into con- tracts under this section, the State of Hawaii shall give
p.001333: preference to Native Hawaiian organizations and Native Hawaiian health cen- ters.
p.001333: (c) DEFINITIONS.—For the purposes of this subsection 18, the terms ‘‘Native Hawaiian’’, ‘‘Native Hawaiian
p.001333: organization’’, and ‘‘Native Hawaiian health center’’ have the meaning given such terms in section 2308 of
p.001333: subtitle D of title II of the Anti-Drug Abuse Act of 1988.
p.001333: SEC. 1954. ø300x–64¿ DEFINITIONS.
p.001333: (a) DEFINITIONS FOR SUBPART III.—For purposes of this sub- part:
p.001333: (1) The term ‘‘program involved’’ means the program of grants established in section 1911 or 1921, or
p.001333: both, as indi- cated by whether the State involved is receiving or is applying to receive a grant under section 1911
p.001333: or 1921, or both.
p.001333: (2)(A) The term ‘‘funding agreement’’, with respect to a grant under section 1911, has the meaning given such
p.001333: term in section 1919.
p.001333: (B) The term ‘‘funding agreement’’, with respect to a grant under section 1921, has the meaning given such term
p.001333: in sec- tion 1934.
p.001333: (b) DEFINITIONS FOR PART B.—For purposes of this part:
p.001333: (1) The term ‘‘Comptroller General’’ means the Comptroller General of the United States.
p.001333:
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p.001333: 17 Section 1952 appears according to the probable intent of the Congress. Section 3403(b) of Public Law
p.001333: 106–310 (114 Stat. 1220) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1952 ‘‘is amended to read as follows:’’.
p.001333: 18 So in law. See section 203 of Public Law 102–321 (106 Stat. 409). Probably should be ‘‘sec- tion’’.
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p.001335: 1335
p.001335: PUBLIC HEALTH SERVICE ACT
p.001335: Sec. 1955
p.001335:
p.001335: (2) The term ‘‘State’’, except as provided in sections 1918(c)(5) and 1933(c)(5), means each of the
p.001335: several States, the District of Columbia, and each of the territories of the United States.
p.001335: (3) The term ‘‘territories of the United States’’ means each of the Commonwealth of Puerto Rico, American Samoa, Guam,
p.001335: the Commonwealth of the Northern Mariana Islands, the Vir- gin Islands, Palau, the Marshall Islands, and
p.001335: Micronesia.
p.001335: (4) The term ‘‘interim services’’, in the case of an indi- vidual in need of treatment for substance abuse
p.001335: who has been denied admission to a program of such treatment on the basis of the lack of the capacity of the
p.001335: program to admit the indi- vidual, means services for reducing the adverse health effects of such abuse,
p.001335: for promoting the health of the individual, and for reducing the risk of transmission of disease, which services
p.001335: are provided until the individual is admitted to such a pro- gram.
p.001335: SEC. 1955. ø300x–65¿ SERVICES PROVIDED BY NONGOVERNMENTAL OR-
p.001335: GANIZATIONS. 19
p.001335: (a) PURPOSES.—The purposes of this section are—
p.001335: (1) to prohibit discrimination against nongovernmental or- ganizations and certain individuals on the basis of
p.001335: religion in the distribution of government funds to provide substance abuse services under this
p.001335: title and title V, and the receipt of services under such titles; and
p.001335: (2) to allow the organizations to accept the funds to pro- vide the services to the individuals without
p.001335: impairing the reli- gious character of the organizations or the religious freedom of the individuals.
p.001335: (b) RELIGIOUS ORGANIZATIONS INCLUDED AS NONGOVERN-
p.001335: MENTAL PROVIDERS.—
p.001335: (1) IN GENERAL.—A State may administer and provide sub- stance abuse services under any program under this
p.001335: title or title V through grants, contracts, or cooperative agreements to provide assistance to beneficiaries under
p.001335: such titles with non- governmental organizations.
p.001335: (2) REQUIREMENT.—A State that elects to utilize non- governmental organizations as provided for
p.001335: under paragraph
p.001335: (1) shall consider, on the same basis as other nongovernmental organizations, religious organizations to provide
p.001335: services under substance abuse programs under this title or title V, so long as the programs under such
p.001335: titles are implemented in a man- ner consistent with the Establishment Clause of the first
p.001335: amendment to the Constitution. Neither the Federal Govern- ment nor a State or local government receiving
p.001335: funds under such programs shall discriminate against an organization that provides services under, or applies to
p.001335: provide services under, such programs, on the basis that the organization has a reli- gious character.
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p.001335: January 30, 2020
p.001335: 19 Part G of title V of this Act (the second part G; see page 677) also relates to religious orga- nizations as
p.001335: providers of substance abuse services. That part was added by section 144 of the Community Renewal Tax
p.001335: Relief Act of 2000 (as enacted into law by section 1(a)(7) of Public Law 106–554; 114 Stat. 2763A–619). Section
p.001335: 1955 above was added by section 3305 of Public Law 106–310 (114 Stat. 1212).
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001335: Sec. 1955 PUBLIC HEALTH SERVICE ACT 1336
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p.001335: (c) RELIGIOUS CHARACTER AND INDEPENDENCE.—
p.001335: (1) IN GENERAL.—A religious organization that provides services under any substance abuse program under this
p.001335: title or title V shall retain its independence from Federal, State, and local governments, including such
p.001335: organization’s control over the definition, development, practice, and expression of its reli- gious beliefs.
p.001335: (2) ADDITIONAL SAFEGUARDS.—Neither the Federal Govern- ment nor a State or local government shall require a religious
p.001335: organization—
p.001335: (A) to alter its form of internal governance; or
p.001335: (B) to remove religious art, icons, scripture, or other symbols,
p.001335: in order to be eligible to provide services under any substance abuse program under this title or title V.
p.001335: (d) EMPLOYMENT PRACTICES.—
p.001335: (1) SUBSTANCE ABUSE.—A religious organization that pro- vides services under any substance abuse program
p.001335: under this title or title V may require that its employees providing serv- ices under such program
p.001335: adhere to rules forbidding the use of drugs or alcohol.
p.001335: (2) TITLE VII EXEMPTION.—The exemption of a religious or- ganization provided under section 702 or 703(e)(2) of the
p.001335: Civil Rights Act of 1964 (42 U.S.C. 2000e–1, 2000e–2(e)(2)) regard- ing employment practices shall not be
p.001335: affected by the religious organization’s provision of services under, or receipt of funds from, any substance
p.001335: abuse program under this title or title V.
p.001335: (e) RIGHTS OF BENEFICIARIES OF ASSISTANCE.—
p.001335: (1) IN GENERAL.—If an individual described in paragraph
p.001335: (3) has an objection to the religious character of the organiza- tion from which the individual receives, or
p.001335: would receive, serv- ices funded under any substance abuse program under this title or title V, the appropriate
p.001335: Federal, State, or local govern- mental entity shall provide to such individual (if otherwise eli- gible for such
p.001335: services) within a reasonable period of time after the date of such objection, services that—
p.001335: (A) are from an alternative provider that is accessible to the individual; and
p.001335: (B) have a value that is not less than the value of the services that the individual would have received from such
p.001335: organization.
p.001335: (2) NOTICE.—The appropriate Federal, State, or local gov- ernmental entity shall ensure that notice is
p.001335: provided to indi- viduals described in paragraph (3) of the rights of such individ- uals under this section.
p.001335: (3) INDIVIDUAL DESCRIBED.—An individual described in this paragraph is an individual who receives or
p.001335: applies for services under any substance abuse program under this title or title V.
p.001335: (f) NONDISCRIMINATION AGAINST BENEFICIARIES.—A religious organization providing services through a grant,
p.001335: contract, or coop- erative agreement under any substance abuse program under this title or title V shall not
p.001335: discriminate, in carrying out such program, against an individual described in subsection (e)(3) on the basis of
p.001335: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: 1337
p.001337: PUBLIC HEALTH SERVICE ACT
p.001337: Sec. 1957
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p.001337: January 30, 2020
p.001337: religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in
p.001337: a religious practice.
p.001337: (g) FISCAL ACCOUNTABILITY.—
p.001337: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization providing services under any
p.001337: substance abuse program under this title or title V shall be subject to the same regulations as other
p.001337: nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such
p.001337: funds provided under such program.
p.001337: (2) LIMITED AUDIT.—Such organization shall segregate gov- ernment funds provided under such substance abuse
p.001337: program into a separate account. Only the government funds shall be subject to audit by the government.
p.001337: (h) COMPLIANCE.—Any party that seeks to enforce such party’s rights under this section may assert a civil action for
p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
p.001337: religious organiza- tion to provide services under any substance abuse program under this title or title V shall be
p.001337: expended for sectarian worship, instruc- tion, or proselytization.
p.001337: (j) EFFECT ON STATE AND LOCAL FUNDS.—If a State or local government contributes State or local funds to
p.001337: carry out any sub- stance abuse program under this title or title V, the State or local government may segregate
p.001337: the State or local funds from the Fed- eral funds provided to carry out the program or may commingle the State
p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
p.001337: SEC. 1956. ø300x–66¿ SERVICES FOR INDIVIDUALS WITH CO-OCCUR- RING DISORDERS.
p.001337: States may use funds available for treatment under sections 1911 and 1921 to treat persons with
p.001337: co-occurring substance abuse and mental disorders as long as funds available under such sec- tions are
p.001337: used for the purposes for which they were authorized by law and can be tracked for accounting purposes.
p.001337: SEC. 1957. ø300x-67¿ PUBLIC HEALTH EMERGENCIES.
p.001337: In the case of a public health emergency (as determined under section 319), the Secretary, on a State by State basis,
p.001337: may, as the circumstances of the emergency reasonably require and for the pe-
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001337: Sec. 1958 PUBLIC HEALTH SERVICE ACT 1338
p.001337:
p.001337: riod of the emergency, grant an extension, or waive application deadlines or compliance with any other
p.001337: requirement, of a grant au- thorized under section 521, 1911, or 1921 or an allotment author- ized under
p.001337: Public Law 99–319 (42 U.S.C. 10801 et seq.).
p.001337: SEC. 1958. ø300x-68¿ JOINT APPLICATIONS.
p.001337: The Secretary, acting through the Assistant Secretary for Men- tal Health and Substance Use, shall permit a
p.001337: joint application to be submitted for grants under subpart I and subpart II upon the request of a
p.001337: State. Such application may be jointly reviewed and approved by the Secretary with respect to such subparts,
p.001337: consistent with the purposes and authorized activities of each such grant pro- gram. A State submitting such a
p.001337: joint application shall otherwise meet the requirements with respect to each such subpart.
p.001337:
p.001337: PART C—CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE
p.001337: Subpart I—Data Infrastructure Development
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p.001337: SEC. 1971. ø300y¿ DATA INFRASTRUCTURE DEVELOPMENT.
p.001337: (a) IN GENERAL.—The Secretary may make grants to, and enter into contracts or cooperative agreements with
p.001337: States for the purpose of developing and operating mental health or substance abuse data collection,
p.001337: analysis, and reporting systems with regard to performance measures including capacity, process, and outcomes
p.001337: measures.
p.001337: (b) PROJECTS.—The Secretary shall establish criteria to ensure that services will be available under this
p.001337: section to States that have a fundamental basis for the collection, analysis, and reporting of mental health and
p.001337: substance abuse performance measures and States that do not have such basis. The Secretary will establish cri-
p.001337: teria for determining whether a State has a fundamental basis for the collection, analysis, and reporting of data.
p.001337: (c) CONDITION OF RECEIPT OF FUNDS.—As a condition of the re- ceipt of an award under this section a State
p.001337: shall agree to collect, analyze, and report to the Secretary within 2 years of the date of the award on
p.001337: a core set of performance measures to be determined by the Secretary in conjunction with the States.
p.001337: (d) MATCHING REQUIREMENT.—
p.001337: (1) IN GENERAL.—With respect to the costs of the program to be carried out under subsection (a) by a State, the
p.001337: Secretary may make an award under such subsection only if the appli- cant agrees to make available
p.001337: (directly or through donations from public or private entities) non-Federal contributions to- ward such costs
p.001337: in an amount that is not less than 50 percent of such costs.
p.001337: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001337: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001337: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001337: not be included in determining the amount of such contributions.
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p.001339: 1339
p.001339: PUBLIC HEALTH SERVICE ACT
p.001339: Sec. 1976
p.001339:
p.001339: (e) DURATION OF SUPPORT.—The period during which payments may be made for a project under subsection (a) may
p.001339: be not less than 3 years nor more than 5 years.
p.001339: (f) AUTHORIZATION OF APPROPRIATION.—
p.001339: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated such
p.001339: sums as may be necessary for each of the fiscal years 2001, 2002 and 2003.
p.001339: (2) ALLOCATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall
p.001339: be expended to support data infrastructure development for mental health and 50 percent shall be expended
p.001339: to support data infrastruc- ture development for substance abuse.
p.001339:
p.001339: Subpart II—Interim Maintenance Treatment of Narcotics Dependence
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p.001339: SEC. 1976. ø300y–11¿ INTERIM MAINTENANCE TREATMENT.
p.001339: (a) REQUIREMENT REGARDING SECRETARY.—Subject to the fol- lowing subsections of this section, for the
p.001339: purpose of reducing the incidence of the transmission of HIV disease pursuant to the intra- venous abuse of heroin
p.001339: or other morphine-like drugs, the Secretary, in establishing conditions for the use of methadone in public or
p.001339: nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs—
p.001339: (1) to dispense methadone for treatment purposes to indi- viduals who—
p.001339: (A) meet the conditions for admission to such pro- grams that dispense methadone as part of
p.001339: comprehensive treatment for such dependence; and
p.001339: (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity
p.001339: of the programs, will not gain such admission until 14 or more days after seeking admission to the programs;
p.001339: and
p.001339: (2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in
p.001339: which the individuals are waiting for admission to programs of com- prehensive treatment.
p.001339: (b) INAPPLICABILITY OF REQUIREMENT IN CERTAIN CIR-
p.001339: CUMSTANCES.—
p.001339: (1) IN GENERAL.—The requirement established in sub- section (a) for the Secretary does not apply if any or
p.001339: all of the following conditions are met:
p.001339: (A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease
p.001339: pursuant to the intravenous abuse of drugs is minimal.
p.001339: (B) The preponderance of scientific research indicates that the medically supervised dispensing of
p.001339: methadone is not an effective method of reducing the extent of depend- ence on heroin and other morphine-like
p.001339: drugs.
p.001339: (C) The preponderance of available data indicates that, of treatment programs that dispense methadone
p.001339: as part of comprehensive treatment, a substantial majority
p.001339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001339: Sec. 1976 PUBLIC HEALTH SERVICE ACT 1340
p.001339:
p.001339: admit all individuals seeking services to the programs not later than 14 days after the individuals seek admission to
p.001339: the programs.
p.001339: (2) EVALUATION BY SECRETARY.—In evaluating whether any or all of the conditions described in
p.001339: paragraph (1) have been met, the Secretary shall consult with the National Com- mission on Acquired Immune
p.001339: Deficiency Syndrome.
p.001339: (c) CONDITIONS FOR OBTAINING AUTHORIZATION FROM SEC-
p.001339: RETARY.—
p.001339: (1) IN GENERAL.—In carrying out the requirement estab- lished in subsection (a), the Secretary shall, after
p.001339: consultation with the National Commission on Acquired Immune Deficiency Syndrome, by regulation issue such
p.001339: conditions for treatment programs to obtain authorization from the Secretary to provide interim maintenance
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p.001365:
p.001365: Sec. 2112 PUBLIC HEALTH SERVICE ACT 1366
p.001365:
p.001365: (ii) which are medical files and similar files the disclo- sure of which would constitute a clearly unwarranted inva-
p.001365: sion of privacy,
p.001365: and if the person who submitted such information objects to the inclusion of such information in the
p.001365: decision, the decision shall be disclosed without such information.
p.001365: (e) ACTION BY THE UNITED STATES CLAIMS COURT.—
p.001365: (1) Upon issuance of the special master’s decision, the par- ties shall have 30 days to file with the clerk
p.001365: of the United States Claims Court a motion to have the court review the de- cision. If such a motion is filed, the
p.001365: other party shall file a re- sponse with the clerk of the United States Claims Court no later than 30 days
p.001365: after the filing of such motion.
p.001365: (2) Upon the filing of a motion under paragraph (1) with respect to a petition, the United States
p.001365: Claims Court shall have jurisdiction to undertake a review of the record of the proceedings and may
p.001365: thereafter—
p.001365: (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master’s
p.001365: deci- sion,
p.001365: (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary,
p.001365: capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings
p.001365: of fact and conclusions of law, or
p.001365: (C) remand the petition to the special master for fur- ther action in accordance with the court’s direction.
p.001365: The court shall complete its action on a petition within 120 days of the filing of a response under
p.001365: paragraph (1) excluding any days the petition is before a special master as a result of a remand under
p.001365: subparagraph (C). The court may allow not more than 90 days for remands under subparagraph (C).
p.001365: (3) In the absence of a motion under paragraph (1) respect- ing the special master’s decision or if the United States
p.001365: Claims Court takes the action described in paragraph (2)(A) with re- spect to the special master’s
p.001365: decision, the clerk of the United States Claims Court shall immediately enter judgment in ac- cordance
p.001365: with the special master’s decision.
p.001365: (f) APPEALS.—The findings of fact and conclusions of law of the United States Claims Court on a petition shall be final
p.001365: determina- tions of the matters involved, except that the Secretary or any peti- tioner aggrieved by the findings or
p.001365: conclusions of the court may ob- tain review of the judgment of the court in the United States court of appeals for the
p.001365: Federal Circuit upon petition filed within 60 days of the date of the judgment with such court of appeals
p.001365: within 60 days of the date of entry of the United States Claims Court’s 5 judg- ment with such court of appeals.
p.001365: (g) 6 NOTICE.—If—
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365:
p.001365: January 30, 2020
p.001365: 5 So in law. Probably should be a reference to the United States Court of Federal Claims.
...

p.001395: (d) ANNUAL REPORTS TO CONGRESS.—Except as provided in subsection (e), the Secretary shall annually
p.001395: prepare, for inclusion in the comprehensive report required in section 2301, a report—
p.001395:
p.001395: (A) 2 summarizing programs for which the Secretary has made a determination described in subsection
p.001395: (b)(2), including a description of the time limitations as adjusted by the deter- mination and including a
p.001395: summary of the solicitation issued by the Secretary for proposals pursuant to the program; and
p.001395: (B) summarizing applications that—
p.001395: (i) were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in
p.001395: para- graph (1) of subsection (b) for which a determination de- scribed in paragraph (2) of such
p.001395: subsection has not been made; and
p.001395: (ii) were not processed in accordance with the time limitations described in such paragraph (1).
p.001395: (e) QUARTERLY REPORTS FOR FISCAL YEAR 1989.—For fiscal year 1989, the report required in subsection (d)
p.001395: shall, not less than quarterly, be prepared and submitted to the Committee on Energy and Commerce of the House of
p.001395: Representatives and the Committee on Labor and Human Resources of the Senate.
p.001395: SEC. 2303. ø300cc–2¿ REQUIREMENTS WITH RESPECT TO PROCESSING OF REQUESTS FOR PERSONNEL AND
p.001395: ADMINISTRATIVE SUPPORT.
p.001395: (a) IN GENERAL.—The Director of the Office of Personnel Man- agement or the Administrator of General Services, as the
p.001395: case may be, shall respond to any priority request made by the Adminis- trator of the Alcohol, Drug Abuse,
p.001395: and Mental Health Administra- tion, the Director of the Centers for Disease Control and Preven- tion, the
p.001395: Commissioner of Food and Drugs, or the Director of the National Institutes of Health, not later than 21 days
p.001395: after the date on which such request is made. If the Director of the Office of Per- sonnel Management or the
p.001395: Administrator of General Services, as
p.001395:
p.001395:
p.001395:
p.001395:
p.001395: January 30, 2020
p.001395: 2 Designations are so in law. Subparagraphs (A) and (B) should probably be designated para- graphs (1) and (2),
p.001395: respectively. Similarly, clauses (i) and (ii) of subparagraph (B) should prob- ably be designated
p.001395: subparagraphs (A) and (B), respectively.
p.001395: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001395:
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p.001395:
p.001397: 1397
p.001397: PUBLIC HEALTH SERVICE ACT
p.001397: Sec. 2304
p.001397:
p.001397:
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p.001397:
p.001397: January 30, 2020
p.001397: the case may be, does not disapprove a priority request during the 21-day period, the request shall be deemed to be
p.001397: approved.
p.001397: (b) NOTICE TO SECRETARY AND TO ASSISTANT SECRETARY FOR HEALTH.—The Administrator of the Substance Abuse
p.001397: and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention,
p.001397: the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall, respectively,
p.001397: transmit to the Secretary and the Assistant Secretary for Health a copy of each priority request made under this
p.001397: section by the agency head involved. The copy shall be transmitted on the date on which the priority request involved
p.001397: is made.
p.001397: (c) DEFINITION OF PRIORITY REQUEST.—For purposes of this section, the term ‘‘priority request’’ means any
p.001397: request that—
p.001397: (1) is designated as a priority request by the Administrator of the Substance Abuse and Mental Health Services
p.001397: Adminis- tration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and
p.001397: Drugs, or the Direc- tor of the National Institutes of Health; and
p.001397: (2)(A) is made to the Director of the Office of Personnel Management for the allocation of personnel to carry
p.001397: out activi- ties with respect to acquired immune deficiency syndrome; or
p.001397: (B) is made to the Administrator of General Services for administrative support or space in carrying out such
p.001397: activities.
p.001397: SEC. 2304. ø300cc–3¿ ESTABLISHMENT OF RESEARCH ADVISORY COM- MITTEE.
p.001397: (a) IN GENERAL.—After consultation with the Commissioner of Food and Drugs, the Secretary, acting through the
p.001397: Director of the National Institute of Allergy and Infectious Diseases, shall estab- lish within such
p.001397: Institute an advisory committee to be known as the AIDS Research Advisory Committee (hereafter in this
p.001397: section referred to as the ‘‘Committee’’).
p.001397: (b) COMPOSITION.—The Committee shall be composed of physi- cians whose clinical practice includes a significant
p.001397: number of pa- tients with acquired immune deficiency syndrome.
p.001397: (c) DUTIES.—The Committee shall—
p.001397: (1) advise the Director of such Institute (and may provide advice to the Directors of other agencies of the
p.001397: National Insti- tutes of Health, as appropriate) on appropriate research activi- ties to be undertaken with respect to
p.001397: clinical treatment of such syndrome, including advice with respect to—
p.001397: (A) research on drugs for preventing or minimizing the development of symptoms or conditions arising from infec- tion
...

p.001429: (4) the availability in the geographic area of any appro- priate services with respect to health care,
p.001429: including mental health care and social and support services;
p.001429: (5) the benefits of locating and counseling any individual by whom the infected individual may have been
p.001429: exposed to the etiologic agent for acquired immune deficiency syndrome and any individual whom the infected
p.001429: individual may have exposed to such etiologic agent; and
p.001429: (6) the availability, if any, of the services of public health authorities with respect to locating and
p.001429: counseling any indi- vidual described in paragraph (5).
p.001429: (d) RULE OF CONSTRUCTION WITH RESPECT TO COUNSELING WITHOUT TESTING.—Agreements entered into
p.001429: pursuant to sub- sections (a) through (c) may not be construed to prohibit any grant- ee under section 2431 from
p.001429: expending the grant for the purpose of providing counseling services described in such subsections to an
p.001429: individual who will not undergo testing described in such section as a result of the grantee or the
p.001429: individual determining that such testing of the individual is not appropriate.
p.001429: (e) USE OF FUNDS.—
p.001429: (1) The purpose of this subpart 4 is to provide for coun- seling and testing services to prevent and
p.001429: reduce exposure to, and transmission of, the etiologic agent for acquired immune deficiency syndrome.
p.001429: (2) All individuals receiving counseling pursuant to this subpart 4 are to be counseled about the harmful
p.001429: effects of pro- miscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such
p.001429: activities.
p.001429: (3) None of the fund appropriated to carry out this sub- part 4 may be used to provide counseling
p.001429: that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous
p.001429: drug abuse.
p.001429: (4) Paragraph (3) may not be construed to prohibit a coun- selor who has already performed the counseling of an
p.001429: indi- vidual required by paragraph (2), to provide accurate informa- tion about means to reduce an individual’s risk
p.001429: of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
p.001429: informational materials used are not obscene.
p.001429: SEC. 2433. ø300dd–33¿ FUNDING.
p.001429: For the purpose of grants under section 2431, there are author- ized to be appropriated $100,000,000 for each of
p.001429: the fiscal years 1989 and 1990.
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429:
p.001429: January 30, 2020
p.001429: 4 Probably should be ‘‘part’’. See section 118(b)(1)(B) of Public Law 102–321 (106 Stat. 348).
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001429:
p.001429:
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p.001429:
p.001431: 1431
p.001431: PUBLIC HEALTH SERVICE ACT
p.001431: Sec. 2502
p.001431:
p.001431: TITLE XXV—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001431: SEC. 2500. ø300ee¿ USE OF FUNDS.
p.001431: (a) IN GENERAL.—The purpose of this title is to provide for the establishment of education and information
p.001431: programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune
p.001431: deficiency syndrome.
p.001431: (b) CONTENTS OF PROGRAMS.—All programs of education and information receiving funds under this title shall
p.001431: include informa- tion about the harmful effects of promiscuous sexual activity and intravenous substance
p.001431: abuse, and the benefits of abstaining from such activities.
p.001431: (c) LIMITATION.—None of the funds appropriated to carry out this title may be used to provide education or
p.001431: information designed to promote or encourage, directly, homosexual or heterosexual sex- ual activity or intravenous
p.001431: substance abuse.
p.001431: (d) CONSTRUCTION.—Subsection (c) may not be construed to re- strict the ability of an education program that
p.001431: includes the infor- mation required in subsection (b) to provide accurate information about various means
p.001431: to reduce an individual’s risk of exposure to, or the transmission of, the etiologic agent for acquired immune
p.001431: de- ficiency syndrome, provided that any informational materials used are not obscene.
p.001431: PART A—FORMULA GRANTS TO STATES
p.001431: SEC. 2501. ø300ee–11¿ ESTABLISHMENT OF PROGRAM.
p.001431: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001431: fiscal years 1989 through 1991 make an allotment for each State in an amount de- termined in accordance
p.001431: with section 2507. The Secretary shall make payments each such fiscal year to each State from the allot- ment for
p.001431: the State if the Secretary approves for the fiscal year in- volved an application submitted by the State
p.001431: pursuant to section 2503.
p.001431: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001431: unless the State in- volved agrees to expend the payments only for the purpose of car- rying out, in
p.001431: accordance with section 2502, public information ac- tivities with respect to acquired immune deficiency
p.001431: syndrome.
p.001431: SEC. 2502. ø300ee–12¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.001431: A State may expend payments received under section 2501(a)—
p.001431: (1) to develop, establish, and conduct public information activities relating to the prevention and
...

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p.001443: January 30, 2020
p.001443:
p.001443: (1) ESTABLISHMENT.—To be eligible for assistance under this subpart, the chief elected official described
p.001443: in subsection (a)(1) shall establish or designate an HIV health services plan- ning council that shall reflect in
p.001443: its composition the demo- graphics of the population of individuals with HIV/AIDS in the eligible area involved,
p.001443: with particular consideration given to disproportionately affected and historically underserved groups and
p.001443: subpopulations. Nominations for membership on the coun- cil shall be identified through an open process and
p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
...

p.001445: (ii) disparities in access and services among af- fected subpopulations and historically underserved
p.001445: communities; and
p.001445: (iii) individuals with HIV/AIDS who do not know their HIV status;
p.001445: (C) establish priorities for the allocation of funds with- in the eligible area, including how best to meet each such
p.001445: priority and additional factors that a grantee should con- sider in allocating funds under a grant based on
p.001445: the—
p.001445: (i) size and demographics of the population of indi- viduals with HIV/AIDS (as determined under subpara- graph (A)) and
p.001445: the needs of such population (as deter- mined under subparagraph (B));
p.001445: (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and
p.001445: interventions, to the extent that data are reasonably available;
p.001445: (iii) priorities of the communities with HIV/AIDS for whom the services are intended;
p.001445: (iv) coordination in the provision of services to such individuals with programs for HIV prevention and
p.001445: for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for
p.001445: such abuse;
p.001445: (v) availability of other governmental and non- governmental resources, including the State medicaid plan
p.001445: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001445: Act to cover health care costs of eligible individuals and families with HIV/AIDS; and
p.001445: (vi) capacity development needs resulting from disparities in the availability of HIV-related services
p.001445: in historically underserved communities;
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001445:
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p.001445: Sec. 2602 PUBLIC HEALTH SERVICE ACT 1446
p.001445:
p.001445: (D) develop a comprehensive plan for the organization and delivery of health and support services described in
p.001445: section 2604 that—
p.001445: (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services
p.001445: and for informing the individuals of and ena- bling the individuals to utilize the services, giving par- ticular
p.001445: attention to eliminating disparities in access and services among affected subpopulations and his- torically
p.001445: underserved communities, and including dis- crete goals, a timetable, and an appropriate allocation of funds;
p.001445: (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (in- cluding
p.001445: outreach and early intervention) and for the prevention and treatment of substance abuse (includ- ing
p.001445: programs that provide comprehensive treatment services for such abuse);
p.001445: (iii) is compatible with any State or local plan for the provision of services to individuals with HIV/AIDS; and
p.001445:
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p.001445: January 30, 2020
p.001445: (iv) includes a strategy, coordinated as appro- priate with other community strategies and efforts, in-
p.001445: cluding discrete goals, a timetable, and appropriate funding, for identifying individuals with HIV/AIDS
p.001445: who do not know their HIV status, making such indi- viduals aware of such status, and enabling such indi-
p.001445: viduals to use the health and support services de- scribed in section 2604, with particular attention to re-
p.001445: ducing barriers to routine testing and disparities in access and services among affected subpopulations and
p.001445: historically underserved communities;
p.001445: (E) assess the efficiency of the administrative mecha- nism in rapidly allocating funds to the areas of
p.001445: greatest need within the eligible area, and at the discretion of the planning council, assess the
p.001445: effectiveness, either directly or through contractual arrangements, of the services offered in meeting the
p.001445: identified needs;
p.001445: (F) participate in the development of the statewide co- ordinated statement of need initiated by the State
...

p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
p.001459:
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p.001459:
p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001459:
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p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
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p.001463: January 30, 2020
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p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
p.001463: (B) by an entity that provides health services on a pre- paid basis;
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p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001473:
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p.001473: Sec. 2612 PUBLIC HEALTH SERVICE ACT 1474
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p.001473: January 30, 2020
p.001473:
p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
...

p.001475: (f) CONSTRUCTION.—A State may not use amounts received under a grant awarded under section 2611 to purchase or
p.001475: improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or
p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
...

p.001481: under title XIX of the Social Security Act and the State Children’s Health Insurance Program under title XXI of such
p.001481: Act to cover health care costs of eligible individuals and families with HIV/AIDS;
p.001481: (iii) capacity development needs resulting from disparities in the availability of HIV-related services
p.001481: in historically underserved communities and rural communities; and
p.001481: (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of
p.001481: greatest need within the State;
p.001481: (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and
p.001481: for informing the individuals of and enabling the indi- viduals to utilize the services, giving particular
p.001481: attention to eliminating disparities in access and services among af- fected subpopulations and historically
p.001481: underserved commu- nities, and including discrete goals, a timetable, and an ap- propriate allocation of funds;
p.001481: (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention
p.001481: (including outreach and early intervention) and for the prevention and treatment of substance abuse
p.001481: (including programs that provide comprehensive treatment services for such abuse);
p.001481: (D) describes the services and activities to be provided and an explanation of the manner in which the
p.001481: elements of the program to be implemented by the State with such assistance will maximize the quality of
p.001481: health and support services available to individuals with HIV/AIDS through- out the State;
p.001481: (E) provides a description of the manner in which services funded with assistance provided under section
p.001481: 2611 will be coordinated with other available related serv- ices for individuals with HIV/AIDS;
p.001481: (F) provides a description of how the allocation and utilization of resources are consistent with the
p.001481: statewide coordinated statement of need (including traditionally un- derserved populations and subpopulations)
p.001481: developed in
p.001481:
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p.001481:
p.001481: January 30, 2020
p.001481: 7 The placement of subparagraphs (A) through (C) is according to the probable intent of the Congress.
p.001481: Section 205(a)(3) of Public Law 106–345 (114 Stat. 1332, 1333) amended paragraph
p.001481: (4) by redesignating subparagraphs (A) through (C) as subparagraphs (D) through (F), and then instructed that new
p.001481: subparagraphs (A) through (C) be inserted before ‘‘subparagraph (C)’’. The amendment probably should have
p.001481: instructed that the new subparagraphs be inserted before sub- paragraph (D), as redesignated.
p.001481: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001481:
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p.001483:
p.001483: health and support services provided by entities that re- ceive funds from the State under section 2611;
p.001483: (D) the State will permit and cooperate with any Fed- eral investigations undertaken regarding programs con-
p.001483: ducted under section 2611;
p.001483: (E) the State will maintain HIV-related activities at a level that is equal to not less than the level of
p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
p.001483: (E) describing efforts to remove legal barriers, includ- ing State laws and regulations, to routine testing.
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p.001501: January 30, 2020
p.001501:
p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
p.001501: (g) DEFINITIONS.—In this section:
p.001501: (1) The term ‘‘voluntary opt-out testing’’ means HIV/AIDS testing—
p.001501: (A) that is administered to an individual seeking other health care services; and
p.001501: (B) in which—
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p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
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p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
p.001507: (A) counseling individuals with respect to HIV/AIDS in accordance with section 2662;
p.001507: (B) testing individuals with respect to HIV/AIDS, in- cluding tests to confirm the presence of the
p.001507: disease, tests to diagnose the extent of the deficiency in the immune sys-
p.001507: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001507:
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p.001507:
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p.001509: 1509
p.001509: PUBLIC HEALTH SERVICE ACT
p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
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p.001509: January 30, 2020
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p.001509: (B) A determination by the Secretary of whether an entity referred to in subparagraph (A) meets the
p.001509: criteria for a waiver under such subparagraph shall be made with- out regard to whether the entity accepts
p.001509: voluntary dona- tions regarding the provision of services to the public.
p.001509: SEC. 2653. ø300ff–53¿ PREFERENCES IN MAKING GRANTS.
p.001509: (a) IN GENERAL.—In making grants under section 2651, the Secretary shall give preference to any qualified
p.001509: applicant experi- encing an increase in the burden of providing services regarding HIV/AIDS, as indicated
p.001509: by the factors specified in subsection (b).
p.001509: (b) SPECIFICATION OF FACTORS.—
p.001509: (1) IN GENERAL.—In the case of the geographic area with respect to which the entity involved is
p.001509: applying for a grant under section 2651, the factors referred to in subsection (a), as determined for the period
p.001509: specified in paragraph (2), are—
p.001509: (A) the number of cases of HIV/AIDS;
p.001509: (B) the rate of increase in such cases;
p.001509: (C) the lack of availability of early intervention serv- ices;
p.001509: (D) the number of other cases of sexually transmitted diseases, and the number of cases of tuberculosis
p.001509: and of drug abuse and the number of cases of individuals co-in- fected with HIV/AIDS and hepatitis B or C;
p.001509: (E) the rate of increase in each of the cases specified in subparagraph (D);
p.001509: (F) the lack of availability of primary health services from providers other than such applicant; and
p.001509: (G) the distance between such area and the nearest community that has an adequate level of availability of ap-
p.001509: propriate HIV-related services, and the length of time re- quired to travel such distance.
p.001509: (2) RELEVANT PERIOD OF TIME.—The period referred to in paragraph (1) is the 2-year period preceding the fiscal
p.001509: year for which the entity involved is applying to receive a grant under section 2651.
p.001509: (c) EQUITABLE ALLOCATIONS.—In providing preferences for pur- poses of subsection (b), the Secretary shall
p.001509: equitably allocate the preferences among urban and rural areas.
p.001509: (d) CERTAIN AREAS.—Of the applicants who qualify for pref- erence under this section—
p.001509: (1) the Secretary shall give preference to applicants that will expend the grant under section 2651 to
p.001509: provide early intervention under such section in rural areas; and
p.001509: (2) the Secretary shall give preference to areas that are underserved with respect to such services.
p.001509: SEC. 2654. ø300ff–54¿ MISCELLANEOUS PROVISIONS.
p.001509: (a) SERVICES FOR INDIVIDUALS WITH HEMOPHILIA.—In making grants under section 2651, the Secretary shall
p.001509: ensure that any such grants made regarding the provision of early intervention services to individuals with
p.001509: hemophilia are made through the net- work of comprehensive hemophilia diagnostic and treatment cen- ters.
...

p.001517: SEC. 2666. ø300ff–66¿ PROVISION BY SECRETARY OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001517: (a) IN GENERAL.—Upon the request of a grantee under this part, the Secretary may, subject to subsection (b),
p.001517: provide supplies, equipment, and services for the purpose of aiding the grantee in providing early
p.001517: intervention services and, for such purpose, may detail to the State any officer or employee of the
p.001517: Department of Health and Human Services.
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
p.001519: elimination of risk of HIV/AIDS for youth.
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p.001519: (2) INDIRECT COSTS.—The term ‘‘indirect costs’’ means costs included in a Federally negotiated indirect rate.
p.001519: (3) SERVICES.—The term ‘‘services’’ means—
p.001519: (A) services that are provided to clients to meet the goals and objectives of the program under this section,
p.001519: in- cluding the provision of professional, diagnostic, and thera- peutic services by a primary care provider or a
p.001519: referral to and provision of specialty care; and
p.001519: (B) services that sustain program activity and con- tribute to or help improve services under
p.001519: subparagraph (A).
p.001519: (i) APPLICATION TO PRIMARY CARE SERVICES.—Nothing in this part shall be construed as requiring funds
p.001519: under this part to be used for primary care services when payments are available for such services from
p.001519: other sources (including under titles XVIII, XIX, and XXI of the Social Security Act).
p.001519: (j) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001519: to be appropriated,
p.001519: $71,800,000 for each of the fiscal years 2007 through 2009,
p.001519: $75,390,000 for fiscal year 2010, $79,160,000 for fiscal year 2011,
p.001519: $83,117,000 for fiscal year 2012, and $87,273,000 for fiscal year 2013.
p.001519:
p.001519: PART E—GENERAL PROVISIONS
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p.001519: January 30, 2020
p.001519: SEC. 2681. ø300ff–81¿ COORDINATION.
p.001519: (a) REQUIREMENT.—The Secretary shall ensure that the Health Resources and Services Administration, the Centers
p.001519: for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the
p.001519: Centers for Medicare & Medicaid Services coordinate the planning, funding, and implementation of Federal HIV
p.001519: programs (including all minority AIDS initiatives of
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001521: PUBLIC HEALTH SERVICE ACT
p.001521: Sec. 2683
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p.001521: the Public Health Service, including under section 2693) to enhance the continuity of care and prevention
p.001521: services for individuals with HIV/AIDS or those at risk of such disease. The Secretary shall con- sult with other
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p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
p.001521: include a history of program activities within each relevant agency and a description of activi- ties
p.001521: conducted, people served and types of grantees funded, and shall collect and describe best practices in
p.001521: community outreach and capacity-building of community based organizations serving the communities that are
p.001521: disproportionately affected by HIV/AIDS.
p.001521: SEC. 2687. ø300ff–87¿ SEVERITY OF NEED INDEX.
p.001521: (a) DEVELOPMENT OF INDEX.—Not later than September 30, 2008, the Secretary shall develop and submit to
p.001521: the appropriate
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001523: PUBLIC HEALTH SERVICE ACT
p.001523: Sec. 2688
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p.001619: (A) develop fee schedules and other database tools that fairly and accurately reflect market rates for medical serv-
p.001619: ices and the geographic differences in those rates;
p.001619: (B) use the best available statistical methods and data processing technology to develop such fee schedules and
p.001619: other database tools;
p.001619: (C) regularly update such fee schedules and other database tools to reflect changes in charges for
p.001619: medical services;
p.001619: (D) make health care cost information readily avail- able to the public through an Internet website that allows
p.001619: consumers to understand the amounts that health care providers in their area charge for particular medical serv-
p.001619: ices; and
p.001619: (E) regularly publish information concerning the sta- tistical methodologies used by the center to analyze health
p.001619: charge data and make such data available to researchers and policy makers.
p.001619: (2) CONFLICTS OF INTEREST.—A center established under subsection (c)(1)(C) shall adopt by-laws that ensures
p.001619: that the center (and all members of the governing board of the center) is independent and free from all
p.001619: conflicts of interest. Such by- laws shall ensure that the center is not controlled or influenced by, and does not have
p.001619: any corporate relation to, any individual or entity that may make or receive payments for health care
p.001619: services based on the center’s analysis of health care costs.
p.001619: (3) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to permit a center established
p.001619: under sub- section (c)(1)(C) to compel health insurance issuers to provide data to the center.
p.001619: SEC. 2794. ø300gg–95¿ UNIFORM FRAUD AND ABUSE REFERRAL FOR- MAT. 30
p.001619: The Secretary shall request the National Association of Insur- ance Commissioners to develop a model uniform
p.001619: report form for private health insurance issuer seeking to refer suspected fraud and abuse to State
p.001619: insurance departments or other responsible State agencies for investigation. The Secretary shall request
p.001619: that
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p.001619: January 30, 2020
p.001619: 30 So in law. There are two sections 2794s’. Sections 1003 and 6603 of Public Law 111–148 add new
p.001619: section 2794s’ to the end of part C of title XXVII.
p.001619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001621: PUBLIC HEALTH SERVICE ACT
p.001621: Sec. 2802
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p.001621: the National Association of Insurance Commissioners develop rec- ommendations for uniform reporting
p.001621: standards for such referrals.
p.001621:
p.001621: TITLE XXVIII—NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH EMERGENCIES
p.001621: Subtitle A—National All-Hazards Pre- paredness and Response Planning, Co- ordinating, and Reporting
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p.001621: SEC. 2801. ø42 U.S.C. 300hh¿ PUBLIC HEALTH AND MEDICAL PRE- PAREDNESS AND RESPONSE FUNCTIONS.
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p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
p.001635: more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
p.001635: (e) MEETINGS.—The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be
p.001635: an in-per- son meeting.
p.001635: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001635: accordance with section 2811D.
p.001635: (g) SUNSET.—The Advisory Committee shall terminate on Sep- tember 30, 2023.
p.001635: SEC. 2811B. ø42 U.S.C. 300hh-10c¿ NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.
p.001635: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security and the Secretary
p.001635: of Veterans Af-
p.001635: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001687: of the programs under this section, including the recovery of reasonable costs expended to establish a Loan Fund which
p.001687: are incurred after the date of the enactment of this title.
p.001687: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001689: Sec. 3015
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p.001689: (3) GUIDANCE AND REGULATIONS.—The National Coordi- nator shall publish guidance and promulgate regulations
p.001689: as may be necessary to carry out the provisions of this section, in- cluding—
p.001689: (A) provisions to ensure that each eligible entity com- mits and expends funds allotted to the entity
p.001689: under this section as efficiently as possible in accordance with this title and applicable State laws; and
p.001689: (B) guidance to prevent waste, fraud, and abuse.
p.001689: (4) PRIVATE SECTOR CONTRIBUTIONS.—
p.001689: (A) IN GENERAL.—A Loan Fund established under this section may accept contributions from private sector enti-
p.001689: ties, except that such entities may not specify the recipient or recipients of any loan issued under this
p.001689: subsection. An eligible entity may agree to reimburse a private sector en- tity for any contribution made under
p.001689: this subparagraph, except that the amount of such reimbursement may not be greater than the principal amount
p.001689: of the contribution made.
p.001689: (B) AVAILABILITY OF INFORMATION.—An eligible entity shall make publicly available the identity of, and
p.001689: amount contributed by, any private sector entity under subpara- graph (A) and may issue letters of commendation
p.001689: or make other awards (that have no financial value) to any such en- tity.
p.001689: (h) MATCHING REQUIREMENTS.—
p.001689: (1) IN GENERAL.—The National Coordinator may not make a grant under subsection (a) to an eligible entity unless the
p.001689: en- tity agrees to make available (directly or through donations from public or private entities)
p.001689: non-Federal contributions in cash to the costs of carrying out the activities for which the grant is
p.001689: awarded in an amount equal to not less than $1 for each $5 of Federal funds provided under the grant.
p.001689: (2) DETERMINATION OF AMOUNT OF NON-FEDERAL CON- TRIBUTION.—In determining the amount of
p.001689: non-Federal con- tributions that an eligible entity has provided pursuant to sub- paragraph (A), the National
p.001689: Coordinator may not include any amounts provided to the entity by the Federal Government.
p.001689: (i) EFFECTIVE DATE.—The Secretary may not make an award under this section prior to January 1, 2010.
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p.001693: (ii) if conducted by a health care provider, such pro- vider knows that such practice is unreasonable and is
p.001693: like- ly to interfere with, prevent, or materially discourage ac- cess, exchange, or use of electronic health
p.001693: information.
p.001693: (2) PRACTICES DESCRIBED.—The information blocking prac- tices described in paragraph (1) may include—
p.001693: (A) practices that restrict authorized access, exchange, or use under applicable State or Federal law of such infor-
p.001693: mation for treatment and other permitted purposes under such applicable law, including transitions between
p.001693: certified health information technologies;
p.001693: (B) implementing health information technology in nonstandard ways that are likely to substantially increase
p.001693: the complexity or burden of accessing, exchanging, or using electronic health information; and
p.001693: (C) implementing health information technology in ways that are likely to—
p.001693: (i) restrict the access, exchange, or use of elec- tronic health information with respect to exporting
p.001693: complete information sets or in transitioning between health information technology systems; or
p.001693: (ii) lead to fraud, waste, or abuse, or impede inno- vations and advancements in health information ac- cess,
p.001693: exchange, and use, including care delivery en- abled by health information technology.
p.001693: (3) RULEMAKING.—The Secretary, through rulemaking, shall identify reasonable and necessary activities
p.001693: that do not constitute information blocking for purposes of paragraph (1).
p.001693: (4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.—The term ‘‘information blocking’’ does not include any
p.001693: practice or conduct occurring prior to the date that is 30 days after the date of enactment of the 21st
p.001693: Century Cures Act.
p.001693: (5) CONSULTATION.—The Secretary may consult with the Federal Trade Commission in promulgating regulations
p.001693: under this subsection, to the extent that such regulations define prac- tices that are necessary to promote
p.001693: competition and consumer welfare.
p.001693: (6) APPLICATION.—The term ‘‘information blocking’’, with respect to an individual or entity, shall not
p.001693: include an act or practice other than an act or practice committed by such indi- vidual or entity.
p.001693: (7) CLARIFICATION.—In carrying out this section, the Sec- retary shall ensure that health care providers
p.001693: are not penal- ized for the failure of developers of health information tech- nology or other entities
p.001693: offering health information technology to such providers to ensure that such technology meets the re- quirements to
p.001693: be certified under this title.
p.001693: (b) INSPECTOR GENERAL AUTHORITY.—
p.001693: (1) IN GENERAL.—The inspector general of the Department of Health and Human Services (referred to in this
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p.001717: (ix) Chronic nasopharyngitis.
p.001717: (x) Chronic laryngitis.
p.001717: (xi) Gastroesophageal reflux disorder (GERD).
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001719: 1719
p.001719: PUBLIC HEALTH SERVICE ACT
p.001719: Sec. 3312
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p.001719: January 30, 2020
p.001719: (xii) Sleep apnea exacerbated by or related to a condition described in a previous clause.
p.001719: (B) MENTAL HEALTH CONDITIONS.—
p.001719: (i) Posttraumatic stress disorder (PTSD).
p.001719: (ii) Major depressive disorder.
p.001719: (iii) Panic disorder.
p.001719: (iv) Generalized anxiety disorder.
p.001719: (v) Anxiety disorder (not otherwise specified).
p.001719: (vi) Depression (not otherwise specified).
p.001719: (vii) Acute stress disorder.
p.001719: (viii) Dysthymic disorder.
p.001719: (ix) Adjustment disorder.
p.001719: (x) Substance abuse.
p.001719: (C) MUSCULOSKELETAL DISORDERS FOR CERTAIN WTC RESPONDERS.—In the case of a WTC responder described in
p.001719: paragraph (4), a condition described in such paragraph.
p.001719: (D) ADDITIONAL CONDITIONS.—Any cancer (or type of cancer) or other condition added, pursuant to paragraph
p.001719: (5) or (6), to the list under this paragraph.
p.001719: (4) MUSCULOSKELETAL DISORDERS.—
p.001719: (A) IN GENERAL.—For purposes of this title, in the case of a WTC responder who received any treatment for a
p.001719: WTC-related musculoskeletal disorder on or before Sep- tember 11, 2003, the list of health conditions in
p.001719: paragraph
p.001719: (3) shall include:
p.001719: (i) Low back pain.
p.001719: (ii) Carpal tunnel syndrome (CTS).
p.001719: (iii) Other musculoskeletal disorders.
p.001719: (B) DEFINITION.—The term ‘‘WTC-related musculo- skeletal disorder’’ means a chronic or recurrent disorder of
p.001719: the musculoskeletal system caused by heavy lifting or re- petitive strain on the joints or
p.001719: musculoskeletal system oc- curring during rescue or recovery efforts in the New York City disaster area
p.001719: in the aftermath of the September 11, 2001, terrorist attacks.
p.001719: (5) CANCER.—
p.001719: (A) IN GENERAL.—The WTC Program Administrator shall periodically conduct a review of all available sci-
p.001719: entific and medical evidence, including findings and rec- ommendations of Clinical Centers of Excellence,
p.001719: published in peer-reviewed journals to determine if, based on such evidence, cancer or a certain type of
p.001719: cancer should be added to the applicable list of WTC-related health condi- tions. The WTC Program
p.001719: Administrator shall conduct the first review under this subparagraph not later than 180 days after the date
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p.001731: WTC responders.
p.001731: (b) LIST OF WTC-RELATED HEALTH CONDITIONS FOR SUR- VIVORS.—The list of health conditions for
p.001731: screening-eligible WTC survivors and certified-eligible WTC survivors consists of the fol- lowing:
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p.001731: January 30, 2020
p.001731: (1) AERODIGESTIVE DISORDERS.—
p.001731: (A) Interstitial lung diseases.
p.001731: (B) Chronic respiratory disorder—fumes/vapors.
p.001731: (C) Asthma.
p.001731: (D) Reactive airways dysfunction syndrome (RADS).
p.001731: (E) WTC-exacerbated chronic obstructive pulmonary disease (COPD).
p.001731: (F) Chronic cough syndrome.
p.001731: (G) Upper airway hyperreactivity.
p.001731: (H) Chronic rhinosinusitis.
p.001731: (I) Chronic nasopharyngitis.
p.001731: (J) Chronic laryngitis.
p.001731: (K) Gastroesophageal reflux disorder (GERD).
p.001731: (L) Sleep apnea exacerbated by or related to a condi- tion described in a previous clause.
p.001731: (2) MENTAL HEALTH CONDITIONS.—
p.001731: (A) Posttraumatic stress disorder (PTSD).
p.001731: (B) Major depressive disorder.
p.001731: (C) Panic disorder.
p.001731: (D) Generalized anxiety disorder.
p.001731: (E) Anxiety disorder (not otherwise specified).
p.001731: (F) Depression (not otherwise specified).
p.001731: (G) Acute stress disorder.
p.001731: (H) Dysthymic disorder.
p.001731: (I) Adjustment disorder.
p.001731: (J) Substance abuse.
p.001731: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001731:
p.001731: Sec. 3323 PUBLIC HEALTH SERVICE ACT 1732
p.001731:
p.001731: (3) ADDITIONAL CONDITIONS.—Any cancer (or type of can- cer) or other condition added to the list in
p.001731: section 3312(a)(3) pursuant to paragraph (5) or (6) of section 3312(a), as such pro- visions are applied under
p.001731: subsection (a) with respect to cer- tified-eligible WTC survivors.
p.001731: SEC. 3323. ø42 U.S.C. 300mm–33¿ FOLLOWUP MONITORING AND TREAT- MENT OF OTHER INDIVIDUALS WITH
p.001731: WTC-RELATED HEALTH CONDITIONS.
p.001731: (a) IN GENERAL.—Subject to subsection (c), the provisions of section 3322 shall apply to the followup
p.001731: monitoring and treatment of WTC-related health conditions in the case of individuals de- scribed in
p.001731: subsection (b) in the same manner as such provisions apply to the followup monitoring and treatment of
p.001731: WTC-related health conditions for certified-eligible WTC survivors.
p.001731: (b) INDIVIDUALS DESCRIBED.—An individual described in this subsection is an individual who, regardless of
p.001731: location of resi- dence—
p.001731: (1) is not an enrolled WTC responder or a certified-eligible WTC survivor; and
p.001731: (2) is diagnosed at a Clinical Center of Excellence with a WTC-related health condition for
p.001731: certified-eligible WTC sur- vivors.
p.001731: (c) LIMITATION.—
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p.000001: General Schedule and
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: Sec. 229 PUBLIC HEALTH SERVICE ACT 48
p.000001:
p.000001: shall not exceed the amount of annual compensation (excluding ex- penses) specified in section 102 of title 3, United
p.000001: States Code.
p.000001: (e) Subject to the following sentence, the Secretary may, not- withstanding the provisions of title 5,
p.000001: United States Code, regard- ing appointment, appoint an individual who is separated from the Service
p.000001: involuntarily and without cause to a position in the com- petitive civil service at GS–15 of the
p.000001: General Schedule, and such appointment shall be a career appointment. In the case of such an individual who
p.000001: immediately prior to his appointment to the Service was not a career appointee in the civil service or the Senior
p.000001: Execu- tive Service, such appointment shall be in the excepted civil service and may not exceed a period of 2 years.
p.000001: (f) The Secretary shall promulgate such rules and regulations, not inconsistent with this section, as may be necessary
p.000001: for the effi- cient administration of the Service.
p.000001: SEC. 229. 16 ø237a¿ HEALTH AND HUMAN SERVICES OFFICE ON WOM- EN’S HEALTH.
p.000001: (a) ESTABLISHMENT OF OFFICE.—There is established within the Office of the Secretary, an Office on Women’s
p.000001: Health (referred to in this section as the ‘‘Office’’). The Office shall be headed by a Deputy Assistant
p.000001: Secretary for Women’s Health who may report to the Secretary.
p.000001: (b) DUTIES.—The Secretary, acting through the Office, with re- spect to the health concerns of women, shall—
p.000001: (1) establish short-range and long-range goals and objec- tives within the Department of Health and Human
p.000001: Services and, as relevant and appropriate, coordinate with other appro- priate offices on activities within the
p.000001: Department that relate to disease prevention, health promotion, service delivery, re- search, and public
p.000001: and health care professional education, for issues of particular concern to women throughout their life-
p.000001: span;
p.000001: (2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues
p.000001: relating to women’s health;
p.000001: (3) monitor the Department of Health and Human Serv- ices’ offices, agencies, and regional activities
p.000001: regarding wom- en’s health and identify needs regarding the coordination of ac- tivities, including intramural and
p.000001: extramural multidisciplinary activities;
p.000001: (4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be
p.000001: chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from
p.000001: each of the agencies and offices of the Department of Health and Human Services;
p.000001: (5) establish a National Women’s Health Information Cen- ter to—
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p.000001: January 30, 2020
p.000001: 16 Section 3509 of the Patient Protection and Affordable Care Act (Public Law 111–148, en- acted March 23,
p.000001: 2010) established offices of womens health in the Office of the Secretary of HHS (this section), the Centers for
p.000001: Disease Control and Prevention (section 310A of this Act), the Agency for Healthcare Research and Quality
p.000001: (section 925 of this Act), the Health Resources and Services Administration (section 713 of the Social Security Act),
p.000001: and the Food and Drug Admin- istration (section 1011 of the Federal Food, Drug, and Cosmetic Act).
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 49 PUBLIC HEALTH SERVICE ACT Sec. 231
p.000001:
p.000001: (A) facilitate the exchange of information regarding matters relating to health information, health
p.000001: promotion, preventive health services, research advances, and edu- cation in the appropriate use of health care;
p.000001: (B) facilitate access to such information;
p.000001: (C) assist in the analysis of issues and problems relat- ing to the matters described in this paragraph; and
p.000001: (D) provide technical assistance with respect to the ex- change of information (including facilitating the
p.000001: develop- ment of materials for such technical assistance);
p.000001: (6) coordinate efforts to promote women’s health programs and policies with the private sector; and
p.000001: (7) through publications and any other means appropriate, provide for the exchange of information between the Office
p.000001: and recipients of grants, contracts, and agreements under sub- section (c), and between the Office and
p.000001: health professionals and the general public.
p.000001: (c) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.000001: (1) AUTHORITY.—In carrying out subsection (b), the Sec- retary may make grants to, and enter into
p.000001: cooperative agree- ments, contracts, and interagency agreements with, public and private entities, agencies, and
p.000001: organizations.
p.000001: (2) EVALUATION AND DISSEMINATION.—The Secretary shall directly or through contracts with public and private
p.000001: entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance
p.000001: provided under paragraph
p.000001: (1) and for the dissemination of information developed as a re- sult of such projects.
p.000001: (d) REPORTS.—Not later than 1 year after the date of enact- ment of this section, and every second
p.000001: year thereafter, the Sec- retary shall prepare and submit to the appropriate committees of Congress a
p.000001: report describing the activities carried out under this section during the period for which the report is being
p.000001: prepared.
p.000001: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000001: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000001: PART B—MISCELLANEOUS PROVISIONS
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p.000017: would be promoted by a conference, the Secretary may invite as many of such health authorities and officials
p.000017: of other State or local public or private agencies, institutions, or organizations to confer as he deems
p.000017: necessary or proper. Upon the application of health authorities of five or more States it shall be the
p.000017: duty of the Sec- retary to call a conference of all State health authorities joining in the request. Each State
p.000017: represented at any conference shall be en- titled to a single vote. Whenever at any such conference matters re- lating
p.000017: to mental health are to be discussed, the mental health au- thorities of the respective States shall be invited to
p.000017: attend.
p.000017: (b) From time to time the Secretary shall issue information re- lated to public health, in the form of publications or
p.000017: otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United
p.000017: States and other countries and other perti- nent health information for the use of persons and institutions con- cerned
p.000017: with health services.
p.000017: SEC. 310A. ø242s¿ CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN’S HEALTH.
p.000017: (a) ESTABLISHMENT.—There is established within the Office of the Director of the Centers for Disease Control and
p.000017: Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the
p.000017: ‘‘Office’’). The Office shall be headed by a direc- tor who shall be appointed by the Director of such Centers.
p.000017: (b) PURPOSE.—The Director of the Office shall—
p.000017: (1) report to the Director of the Centers for Disease Con- trol and Prevention on the current level of the
p.000017: Centers’ activity regarding women’s health conditions across, where appro- priate, age, biological, and
p.000017: sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and
p.000017: professional education, services, and treatment;
p.000017: (2) establish short-range and long-range goals and objec- tives within the Centers for women’s health
p.000017: and, as relevant and appropriate, coordinate with other appropriate offices on activities within the
p.000017: Centers that relate to prevention, re- search, education and training, service delivery, and policy de- velopment,
p.000017: for issues of particular concern to women;
p.000017: (3) identify projects in women’s health that should be con- ducted or supported by the Centers;
p.000017: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.000017: profes- sionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to
p.000017: women; and
p.000017: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.000017: Health (established under section 229(b)(4)).
p.000017: (c) DEFINITION.—As used in this section, the term ‘‘women’s health conditions’’, with respect to women of all
p.000017: age, ethnic, and ra- cial groups, means diseases, disorders, and conditions—
p.000017: (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and
p.000017: (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there
p.000017: is rea- sonable evidence that indicates that such factors or types may be different for women.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 311 PUBLIC HEALTH SERVICE ACT 90
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000017: PART B—FEDERAL-STATE COOPERATION
p.000017: IN GENERAL
p.000017: SEC. 311. ø243¿ (a) The Secretary is authorized to accept from State and local authorities any assistance in the
p.000017: enforcement of quarantine regulations made pursuant to this Act which such au- thorities may be able and
p.000017: willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and
p.000017: suppression of communicable diseases and with respect to other public health matters, shall cooperate with and
p.000017: aid State and local authorities in the enforcement of their quarantine and other health regulations, and
p.000017: shall advise the several States on matters relating to the preservation and improvement of the public health.
p.000017: (b) The Secretary shall encourage cooperative activities be- tween the States with respect to
p.000017: comprehensive and continuing planning as to their current and future health needs, the establish- ment and
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p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
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p.000123: EFFECTS OF FOLIC ACID IN PREVENTION OF BIRTH DEFECTS
p.000123: SEC. 317J. ø247b–11¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000123: Control and Pre- vention, shall expand and intensify programs (directly or through grants or contracts) for
p.000123: the following purposes:
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p.000125: PUBLIC HEALTH SERVICE ACT
p.000125: Sec. 317K
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p.000125: (1) To provide education and training for health profes- sionals and the general public for purposes of
p.000125: explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of
p.000125: reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a die- tary supplement that
p.000125: provides an appropriate level of folic acid.
p.000125: (2) To conduct research with respect to such education and training, including identifying effective strategies
p.000125: for increas- ing the rate of consumption of folic acid by women of reproduc- tive capacity.
p.000125: (3) To conduct research to increase the understanding of the effects of folic acid in preventing birth
p.000125: defects, including understanding with respect to cleft lip, cleft palate, and heart defects.
p.000125: (4) To provide for appropriate epidemiological activities re- garding folic acid and birth defects, including
p.000125: epidemiological activities regarding neural tube defects.
p.000125: (b) CONSULTATIONS WITH STATES AND PRIVATE ENTITIES.—In carrying out subsection (a), the Secretary shall
p.000125: consult with the States and with other appropriate public or private entities, includ- ing national nonprofit
p.000125: private organizations, health professionals, and providers of health insurance and health plans.
p.000125: (c) TECHNICAL ASSISTANCE.—The Secretary may (directly or through grants or contracts) provide technical
p.000125: assistance to public and nonprofit private entities in carrying out the activities de- scribed in subsection
p.000125: (a).
p.000125: (d) EVALUATIONS.—The Secretary shall (directly or through grants or contracts) provide for the evaluation
p.000125: of activities under subsection (a) in order to determine the extent to which such activi- ties have been effective in
p.000125: carrying out the purposes of the program under such subsection, including the effects on various demo-
p.000125: graphic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge
p.000125: and attitudes on the consumption of folic acid and on blood folate levels. Such methods may include
p.000125: complete and timely monitoring of infants who are born with neural tube defects.
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p.000125: pregnancy-related deaths that occur during, or within 1 year following, preg- nancy.
p.000125: (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and
p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
p.000127: regardless of the outcome of the pregnancy.
p.000127: (2) PROCESS FOR CONFIDENTIAL REPORTING.—States, Indian tribes, and tribal organizations that participate in the
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p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
p.000131: (1) provide technical and consultative assistance to entities receiving grants under subsection (b);
p.000131: (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease
p.000131: Control and Pre- vention;
p.000131: (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy
p.000131: laws; and
p.000131: (4) coordinate with the National Coordinator for Health In- formation Technology, as appropriate, to assist
p.000131: States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such
p.000131: recognized standards are available, in order to facilitate interoperability between such systems and health
p.000131: information technology systems, in- cluding certified health information technology.
p.000131: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000131: to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
p.000131: SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.000131: (a) GRANTS.—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for
p.000131: screening, assessment, and treatment services, including culturally and linguistically ap- propriate services,
p.000131: as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal
p.000131: depression.
p.000131: (b) APPLICATION.—To seek a grant under this section, a State shall submit an application to the
p.000131: Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a
p.000131: minimum, any such application shall include expla- nations of—
p.000131: (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for
p.000131: mater- nal depression in 1 or more communities; and
p.000131: (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for
p.000131: maternal depression.
p.000131: (c) PRIORITY.—In awarding grants under this section, the Sec- retary may give priority to States proposing to
p.000131: improve or enhance access to screening services for maternal depression in primary care settings.
p.000131: (d) USE OF FUNDS.—The activities eligible for funding through a grant under subsection (a)—
p.000131: (1) shall include—
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131:
p.000131: (A) providing appropriate training to health care pro- viders; and
p.000131: (B) providing information to health care providers, in- cluding information on maternal depression screening,
p.000131: treatment, and followup support services, and linkages to community-based resources; and
p.000131: (2) may include—
p.000131: (A) enabling health care providers (including obstetri- cian-gynecologists, pediatricians, psychiatrists,
p.000131: mental health care providers, and adult primary care clinicians) to provide or receive real-time psychiatric
p.000131: consultation (in- person or remotely) to aid in the treatment of pregnant and parenting women;
p.000131: (B) establishing linkages with and among community- based resources, including mental health resources, pri- mary
p.000131: care resources, and support groups; and
p.000131: (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in
p.000131: section 330I(a)).
p.000131: (e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $5,000,000
p.000131: for each of fiscal years 2018 through 2022.
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p.000131: ORAL HEALTH PROMOTION AND DISEASE PREVENTION
p.000131: SEC. 317M. ø247b–14¿ (a) GRANTS TO INCREASE RESOURCES FOR COMMUNITY WATER FLUORIDATION.—
p.000131: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000131: may make grants to States and Indian tribes for the purpose of in- creasing the resources available for community
p.000131: water fluorida- tion.
p.000131: (2) USE OF FUNDS.—A State shall use amounts provided under a grant under paragraph (1)—
p.000131: (A) to purchase fluoridation equipment;
p.000131: (B) to train fluoridation engineers;
p.000131: (C) to develop educational materials on the benefits of fluoridation; or
p.000131: (D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
p.000131: (b) COMMUNITY WATER FLUORIDATION.—
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p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
p.000135: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000135: such Act;
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p.000135: (B) the head start program established under the
p.000135: Head Start Act (42 U.S.C. 9831 et seq.);
p.000135: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000135: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000135: (D) local public and private elementary or secondary schools; or
p.000135: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000135: U.S.C. 1437a).
p.000135: (c) PERFORMANCE MEASURES.—The Secretary shall establish needs indicators and performance measures to evaluate the
p.000135: activi- ties carried out under grants awarded under this section. Such in- dicators shall be commensurate with
p.000135: national measures of mater- nal and child health programs and shall be developed in consulta- tion with the
p.000135: Director of the Centers for Disease Control and Pre- vention.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000135: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000137: PUBLIC HEALTH SERVICE ACT
p.000137: Sec. 317P
p.000137:
p.000137: HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 13)
p.000137: SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall—
p.000137: (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe-
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p.000137: (C) the available scientific evidence on the effective- ness or lack of effectiveness of condoms in
p.000137: preventing in- fection with HPV; and
p.000137: (D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of
p.000137: cer- vical cancer purposes in preventing cervical cancer.
p.000137: (2) MEDICALLY ACCURATE INFORMATION.—Educational ma- terial under paragraph (1), and all other relevant
p.000137: educational and prevention materials prepared and printed from this date forward for the public and health
p.000137: care providers by the Sec- retary (including materials prepared through the Food and Drug Administration,
p.000137: the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or
p.000137: by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV
p.000137: shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in
p.000137: preventing the STD the materials are designed to address. Such requirement only applies to materials mass
p.000137: produced for the public and health care providers, and not to routine communications.
p.000137: (d) JOHANNA’S LAW.—
p.000137: (1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
p.000137: (A) IN GENERAL.—The Secretary shall carry out a na- tional campaign to increase the awareness and knowledge of
p.000137: health care providers and women with respect to gynecologic cancers.
p.000137: (B) WRITTEN MATERIALS.—Activities under the na- tional campaign under subparagraph (A) shall include—
p.000137: (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers;
p.000137: and
p.000137: (ii) distributing the materials to members of the public upon request.
p.000137: (C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities under the national campaign under subparagraph
p.000137: (A) shall, in accordance with applicable law and regulations, include developing and placing, in
p.000137: telecommunications media, public service announcements intended to encour- age women to discuss with their
p.000137: physicians their risks of gynecologic cancers. Such announcements shall inform the public on the manner in
p.000137: which the written materials re- ferred to in subparagraph (B) can be obtained upon re- quest, and shall
p.000137: call attention to early warning signs and risk factors based on the best available medical informa- tion.
p.000137: (2) REPORT AND STRATEGY.—
p.000137: (A) REPORT.—Not later than 6 months after the date of the enactment of this subsection, the Secretary
p.000137: shall submit to the Congress a report including the following:
p.000137: (i) A description of the past and present activities of the Department of Health and Human Services to increase
p.000137: awareness and knowledge of the public with respect to different types of cancer, including
p.000137: gynecologic cancers.
p.000137: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000139: PUBLIC HEALTH SERVICE ACT
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p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
p.000147: (A) in summary, statistical, or other form; or
p.000147: (B) for clinical or research purposes;
p.000147: but only if the identity of the individuals diagnosed or provided care or treatment under such program is not
p.000147: disclosed.
p.000147: (f) Nothing in this section shall be construed to require any State or any political subdivision of a
p.000147: State to have a sexually transmitted diseases program which would require any person, who objects to any
p.000147: treatment provided under such a program, to be treated under such a program.
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p.000147: INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
p.000147:
p.000147: SEC. 318A. ø247c–1¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000147: Control and Pre- vention, may make grants to States, political subdivisions of States, and other
p.000147: public or nonprofit private entities for the pur- pose of carrying out the activities described in
p.000147: subsection (c) re- garding any treatable sexually transmitted disease that can cause infertility in women if
p.000147: treatment is not received for the disease.
p.000147: (b) AUTHORITY REGARDING INDIVIDUAL DISEASES.—With re- spect to diseases described in subsection (a), the
p.000147: Secretary shall, in making a grant under such subsection, specify the particular dis- ease or diseases with
p.000147: respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000149: agrees to carry out this section only with respect to the disease or diseases so specified.
p.000149: (c) AUTHORIZED ACTIVITIES.—With respect to any sexually transmitted disease described in subsection
p.000149: (a), the activities re- ferred to in such subsection are—
p.000149: (1) screening women for the disease and for secondary con- ditions resulting from the disease, subject to
p.000149: compliance with criteria issued under subsection (f);
p.000149: (2) providing treatment to women for the disease;
p.000149: (3) providing counseling to women on the prevention and control of the disease (including, in the case
p.000149: of a woman with the disease, counseling on the benefits of locating and pro- viding such counseling
p.000149: to any individual from whom the woman may have contracted the disease and any individual whom the
p.000149: woman may have exposed to the disease);
p.000149: (4) providing follow-up services;
p.000149: (5) referrals for necessary medical services for women screened pursuant to paragraph (1), including
p.000149: referrals for evaluation and treatment with respect to acquired immune de- ficiency syndrome and other sexually
p.000149: transmitted diseases;
p.000149: (6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5),
p.000149: providing to the partner of the woman the services described in such paragraphs, as ap- propriate;
p.000149: (7) providing outreach services to inform women of the availability of the services described in paragraphs (1)
p.000149: through (6);
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p.000149: (8) providing to the public information and education on the prevention and control of the disease,
p.000149: including dissemi- nating such information; and
p.000149: (9) providing training to health care providers in carrying out the screenings and counseling described
p.000149: in paragraphs (1) and (3).
p.000149: (d) REQUIREMENT OF AVAILABILITY OF ALL SERVICES THROUGH EACH GRANTEE.—The Secretary may make a grant under
p.000149: sub- section (a) only if the applicant involved agrees that each activity authorized in subsection (c) will
p.000149: be available through the applicant. With respect to compliance with such agreement, the applicant may expend
p.000149: the grant to carry out any of the activities directly, and may expend the grant to enter into
p.000149: agreements with other public or nonprofit private entities under which the entities carry out the
p.000149: activities.
p.000149: (e) REQUIRED PROVIDERS REGARDING CERTAIN SERVICES.—The Secretary may make a grant under subsection (a) only if the
p.000149: appli- cant involved agrees that, in expending the grant to carry out ac- tivities authorized in subsection
p.000149: (c), the services described in para- graphs (1) through (7) of such subsection will be provided only through
p.000149: entities that are State or local health departments, grant- ees under section 329, 330, 340A, or 1001, or are
p.000149: other public or nonprofit private entities that provide health services to a signifi- cant number of
p.000149: low-income women.
p.000149: (f) QUALITY ASSURANCE REGARDING SCREENING FOR DIS-
p.000149: EASES.—For purposes of this section, the Secretary shall establish
p.000149: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000149: criteria for ensuring the quality of screening procedures for dis- eases described in subsection (a).
p.000149: (g) CONFIDENTIALITY.—The Secretary may make a grant under subsection (a) only if the applicant involved agrees, subject
p.000149: to appli- cable law, to maintain the confidentiality of information on individ- uals with respect to activities carried
p.000149: out under subsection (c).
p.000149: (h) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may make a grant under subsection (a)
...

p.000243: the United States, alone or in collaboration with American participants, when such transactions may inure to
p.000243: the ben- efit of the American people.
p.000243: (F) ESTABLISHMENT OF RESEARCH CENTERS.—The Sec- retary may assess the feasibility and appropriateness of
p.000243: establishing, through contract, grant, cooperative agree- ment, or other transaction, an arrangement with an
p.000243: exist- ing research center in order to achieve the goals of this section. If such an agreement is not
p.000243: feasible and appro- priate, the Secretary may establish one or more federally- funded research and
p.000243: development centers, or university-af- filiated research centers, in accordance with section 303(c)(3) of
p.000243: the Federal Property and Administrative Serv- ices Act of 1949 (41 U.S.C. 253(c)(3)).
p.000243: (G) GOVERNMENT PURPOSE.—In awarding contracts, grants, and cooperative agreements under this section, the
p.000243: Secretary shall provide a clear statement of defined Gov- ernment purpose related to activities
p.000243: included in sub- section (a)(6)(B) for a qualified countermeasure or qualified pandemic or epidemic product.
p.000243: (6) AT-RISK INDIVIDUALS.—In carrying out the functions under this section, the Secretary may give priority
p.000243: to the ad- vanced research and development of qualified countermeasures and qualified pandemic or epidemic products
p.000243: that are likely to be safe and effective with respect to children, pregnant women,
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000243:
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p.000243: Sec. 319L PUBLIC HEALTH SERVICE ACT 244
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p.000243: January 30, 2020
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p.000243: older adults, and other at-risk individuals with relevant char- acteristics that warrant consideration during
p.000243: the process of re- searching and developing such countermeasures and products.
p.000243: (7) PERSONNEL AUTHORITIES.—
p.000243: (A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFES- SIONAL PERSONNEL.—
p.000243: (i) IN GENERAL.—In addition to any other per- sonnel authorities, the Secretary may—
p.000243: (I) without regard to those provisions of title 5, United States Code, governing appointments in the
...

p.000251: time) during which the member is engaged in the actual performance of duties as a member of the Board.
p.000251: (C) TRAVEL EXPENSES.—Each member of the Board shall receive travel expenses, including per diem in lieu of
p.000251: subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5,
p.000251: United States Code.
p.000251: (D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board with the
p.000251: approval for the contributing agency without reim- bursement, and such detail shall be without
p.000251: interruption or loss of civil service status or privilege.
p.000251: (b) OTHER WORKING GROUPS.—The Secretary may establish a working group of experts, or may use an existing working
p.000251: group or advisory committee, to—
p.000251: (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified
p.000251: pandemic or epidemic product;
p.000251: (2) identify accepted animal models for particular diseases and conditions associated with any biological,
p.000251: chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify
p.000251: strategies to accelerate animal model and research tool development and validation; and
p.000251: (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified
p.000251: counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective
p.000251: with respect to children, pregnant women, and other vulnerable populations, and other issues regarding
p.000251: activities under this section that affect such populations.
p.000251: (c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same
p.000251: meaning in this section as such term is given in section 319L.
p.000251: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated $1,000,000 to carry out this
p.000251: section for fiscal year 2007 and each fiscal year thereafter.
p.000251: HANSEN’S DISEASE PROGRAM
p.000251: SEC. 320. ø247e¿ (a)(1) At or through the National Hansen’s Disease Programs Center (located in the
p.000251: State of Louisiana), the Secretary shall without charge provide short-term care and treat- ment, including
p.000251: outpatient care, for Hansen’s disease and related complications to any person determined by the Secretary
p.000251: to be in need of such care and treatment. The Secretary may not at or through such Center provide
p.000251: long-term care for any such disease or complication.
p.000251: (2) The Center referred to in paragraph (1) shall conduct train- ing in the diagnosis and management of Hansen’s
p.000251: disease and re- lated complications, and shall conduct and promote the coordina-
p.000251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000253: PUBLIC HEALTH SERVICE ACT
p.000253: Sec. 320A
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p.000263: or substance abuse issues through in- creasing the availability of additional health services described in
p.000263: subsection (b)(2) in an area in which there are significant barriers to accessing care.
p.000263: (iii) CONSIDERATION OF APPLICATIONS.—In car- rying out clause (i), the Secretary shall approve appli- cations
p.000263: for grants in such a manner that the ratio of the medically underserved populations in rural areas
p.000263: which may be expected to use the services provided by the applicants involved to the medically underserved
p.000263: populations in urban areas which may be expected to use the services provided by such applicants is not less
p.000263: than two to three or greater than three to two.
p.000263: (f) INFANT MORTALITY GRANTS.—
p.000263: (1) IN GENERAL.—The Secretary may make grants to health centers for the purpose of assisting such centers
p.000263: in—
p.000263: (A) providing comprehensive health care and support services for the reduction of—
p.000263: (i) the incidence of infant mortality; and
p.000263: (ii) morbidity among children who are less than 3 years of age; and
p.000263: (B) developing and coordinating service and referral arrangements between health centers and other entities
p.000263: for the health management of pregnant women and chil- dren described in subparagraph (A).
p.000263: (2) PRIORITY.—In making grants under this subsection the Secretary shall give priority to health centers
p.000263: providing serv- ices to any medically underserved population among which there is a substantial incidence
p.000263: of infant mortality or among which there is a significant increase in the incidence of infant mortality.
p.000263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000265: PUBLIC HEALTH SERVICE ACT
p.000265: Sec. 330
p.000265:
p.000265: (3) REQUIREMENTS.—The Secretary may make a grant under this subsection only if the health center involved
p.000265: agrees that—
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p.000265: (A) the center will coordinate the provision of services under the grant to each of the recipients of the
p.000265: services;
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p.000283: (b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDI-
p.000283: CALLY UNDERSERVED AREAS.—
p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000283: Administra- tion, may make grants for the purpose of carrying out dem- onstration projects to improve access
p.000283: to health and other serv- ices regarding seizures to encourage early detection and treat- ment in children and others
p.000283: residing in medically underserved areas.
p.000283: (2) APPLICATION FOR GRANT.—A grant may not be awarded under paragraph (1) unless an application therefore is
p.000283: sub- mitted to the Secretary and the Secretary approves such appli- cation. Such application shall be submitted
p.000283: in such form and manner and shall contain such information as the Secretary may prescribe.
p.000283: (c) DEFINITIONS.—For purposes of this section:
p.000283: (1) The term ‘‘epilepsy’’ refers to a chronic and serious neu- rological condition characterized by excessive
p.000283: electrical dis- charges in the brain causing recurring seizures affecting all life activities. The Secretary may
p.000283: revise the definition of such term to the extent the Secretary determines necessary.
p.000283: (2) The term ‘‘medically underserved’’ has the meaning ap- plicable under section 799B(6).
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000283: SEC. 330F. ø254c–6¿ CERTAIN SERVICES FOR PREGNANT WOMEN.
p.000283: (a) INFANT ADOPTION AWARENESS.—
p.000283: (1) IN GENERAL.—The Secretary shall make grants to na- tional, regional, or local adoption organizations for
p.000283: the purpose of developing and implementing programs to train the des- ignated staff of eligible health centers
p.000283: in providing adoption in- formation and referrals to pregnant women on an equal basis with all other
p.000283: courses of action included in nondirective coun- seling to pregnant women.
p.000283: (2) BEST-PRACTICES GUIDELINES.—
p.000283: (A) IN GENERAL.—A condition for the receipt of a grant under paragraph (1) is that the adoption organization
p.000283: in- volved agree that, in providing training under such para- graph, the organization will follow the
p.000283: guidelines devel- oped under subparagraph (B).
p.000283: (B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
p.000283: (i) IN GENERAL.—The Secretary shall establish and supervise a process described in clause (ii) in
p.000283: which the participants are—
p.000283: (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise
p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
p.000285: (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing
p.000285: training for the designated staff of eligible health cen- ters, such organization will make reasonable efforts to
p.000285: ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of
p.000285: the adoption process and are experienced in pro- viding adoption information and referrals in the geo-
p.000285: graphic areas in which the eligible health centers are located, and that the designated staff
p.000285: receive the training in such areas.
p.000285: (B) RULE OF CONSTRUCTION REGARDING TRAINING OF TRAINERS.—With respect to individuals who under a grant under
p.000285: paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subpara-
p.000285: graph as ‘‘trainers’’), subparagraph (A)(iii) may not be con- strued as establishing any limitation regarding the
p.000285: geo- graphic area in which the trainers receive instruction in being such trainers. A trainer may receive such
p.000285: instruction in a different geographic area than the area in which the trainer trains (or will train) the
p.000285: designated staff of eligible health centers.
p.000285:
p.000285:
p.000285:
p.000285: January 30, 2020
p.000285: 35 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: Sec. 330F PUBLIC HEALTH SERVICE ACT 286
p.000285:
p.000285: (4) ADOPTION ORGANIZATIONS; ELIGIBLE HEALTH CENTERS; OTHER DEFINITIONS.—For purposes of this section:
p.000285: (A) The term ‘‘adoption organization’’ means a na- tional, regional, or local organization—
p.000285: (i) among whose primary purposes are adoption;
p.000285: (ii) that is knowledgeable in all elements of the adoption process and on providing adoption informa-
p.000285: tion and referrals to pregnant women; and
p.000285: (iii) that is a nonprofit private entity.
p.000285: (B) The term ‘‘designated staff’’, with respect to an eli- gible health center, means staff of the center who
p.000285: provide pregnancy or adoption information and referrals (or will provide such information and referrals
p.000285: after receiving training under a grant under paragraph (1)).
p.000285: (C) The term ‘‘eligible health centers’’ means public and nonprofit private entities that provide health
p.000285: services to pregnant women.
p.000285: (5) TRAINING FOR CERTAIN ELIGIBLE HEALTH CENTERS.—A condition for the receipt of a grant under paragraph (1) is
p.000285: that the adoption organization involved agree to make reasonable efforts to ensure that the eligible
p.000285: health centers with respect to which training under the grant is provided include—
p.000285: (A) eligible health centers that receive grants under section 1001 (relating to voluntary family
p.000285: planning projects);
p.000285: (B) eligible health centers that receive grants under section 330 (relating to community health centers, migrant
p.000285: health centers, and centers regarding homeless individuals and residents of public housing); and
p.000285: (C) eligible health centers that receive grants under this Act for the provision of services in schools.
p.000285: (6) PARTICIPATION OF CERTAIN ELIGIBLE HEALTH CLINICS.— In the case of eligible health centers that receive grants
p.000285: under section 330 or 1001:
p.000285: (A) Within a reasonable period after the Secretary be- gins making grants under paragraph (1), the Secretary
p.000285: shall provide eligible health centers with complete infor- mation about the training available from
p.000285: organizations re- ceiving grants under such paragraph. The Secretary shall make reasonable efforts to
p.000285: encourage eligible health cen- ters to arrange for designated staff to participate in such training. Such
p.000285: efforts shall affirm Federal requirements, if any, that the eligible health center provide nondirective
p.000285: counseling to pregnant women.
p.000285: (B) All costs of such centers in obtaining the training shall be reimbursed by the organization that
p.000285: provides the training, using grants under paragraph (1).
p.000285: (C) Not later than 1 year after the date of the enact- ment of the Children’s Health Act of 2000 36, the
p.000285: Secretary shall submit to the appropriate committees of the Congress a report evaluating the extent to which
p.000285: adoption informa- tion and referral, upon request, are provided by eligible
p.000285:
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p.000285: January 30, 2020
p.000285: 36 Public Law 106–310, enacted October 17, 2000.
p.000285: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000287: PUBLIC HEALTH SERVICE ACT
p.000287: Sec. 330G
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p.000289: outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the ef-
p.000289: fective date of this section, was a demonstration program car- ried out under section 301.
p.000289: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000289: (1) REQUIREMENTS.—In making grants under subsection (a), the Secretary shall require that applicants (in
p.000289: addition to meeting all eligibility criteria established by the Secretary) es- tablish, for project areas under
p.000289: such subsection, community- based consortia of individuals and organizations (including agencies
p.000289: responsible for administering block grant programs under title V of the Social Security Act, consumers of
p.000289: project services, public health departments, hospitals, health centers under section 330, and other significant
p.000289: sources of health care services) that are appropriate for participation in projects under subsection (a).
p.000289: (2) OTHER CONSIDERATIONS.—In making grants under sub- section (a), the Secretary shall take into consideration
p.000289: the fol- lowing:
p.000289:
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p.000289: January 30, 2020
p.000289: (A) Factors that contribute to infant mortality, such as low birthweight.
p.000289: (B) The extent to which applicants for such grants fa- cilitate—
p.000289: (i) a community-based approach to the delivery of services; and
p.000289: (ii) a comprehensive approach to women’s health care to improve perinatal outcomes.
p.000289: (3) SPECIAL PROJECTS.—Nothing in paragraph (2) shall be construed to prevent the Secretary from
p.000289: awarding grants under subsection (a) for special projects that are intended to address significant
p.000289: disparities in perinatal health indicators in communities along the United States-Mexico border or in Alas- ka or
p.000289: Hawaii.
p.000289: (c) COORDINATION.—Recipients of grants under subsection (a) shall coordinate their services and activities with
p.000289: the State agency
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000289:
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p.000289: Sec. 330I PUBLIC HEALTH SERVICE ACT 290
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p.000289:
p.000289: or agencies that administer block grant programs under title V of the Social Security Act in order to promote
...

p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
p.000465:
p.000465:
p.000465:
p.000465:
p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000465:
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p.000465: Sec. 379 PUBLIC HEALTH SERVICE ACT 466
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p.000465: January 30, 2020
p.000465:
p.000465: (ii) Educating and providing information to preg- nant women who are willing to donate cord blood units.
p.000465: (iii) Training individuals in requesting pregnant women to serve as cord blood donors.
p.000465: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000465: Pro- gram shall give priority to supporting the recruitment of pregnant women to serve as donors of cord blood
p.000465: for popu- lations that are identified under paragraph (1).
p.000465: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000465: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000465: the public regarding cord blood transplants from donors as a treatment option.
p.000465: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000465: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000465: subsection (d)(2).
p.000465: (h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE MARROW AND CORD BLOOD.—
p.000465: (1) IN GENERAL.—The Secretary shall establish and main- tain, through a contract or other means
p.000465: determined appro- priate by the Secretary, an office of patient advocacy (in this subsection referred to as
p.000465: the ‘‘Office’’).
p.000465: (2) GENERAL FUNCTIONS.—The Office shall meet the fol- lowing requirements:
p.000465: (A) The Office shall be headed by a director.
p.000465: (B) The Office shall be staffed by individuals with ex- pertise in bone marrow and cord blood therapy covered
p.000465: under the Program.
p.000465: (C) The Office shall operate a system for patient advo- cacy, which shall be separate from mechanisms for donor
p.000465: advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to
p.000465: conduct, a search for a bone marrow donor or cord blood unit.
p.000465: (D) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the
...

p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000489: January 30, 2020
p.000489: (c) CONSIDERATIONS IN MAKING GRANTS.—In awarding grants under subsection (a), the Secretary shall take
p.000489: into consideration—
...

p.000489: include, as appropriate, other nursing professionals, physician assist- ants, social workers, child welfare
p.000489: professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home
p.000489: visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be
p.000489: required by the mother or child.
p.000489: (g) OUTREACH.—Each grantee under subsection (a) shall pro- vide outreach and casefinding services to inform
p.000489: eligible families of the availability of home visiting services from the project.
p.000489: (h) CONFIDENTIALITY.—In accordance with applicable State law, an entity receiving a grant under subsection
p.000489: (a) shall maintain confidentiality with respect to services provided to families under this section.
p.000489: (i) CERTAIN ASSURANCES.—The Secretary may award a grant under subsection (a) only if the entity involved
p.000489: provides assurances satisfactory to the Secretary that—
p.000489: (1) the entity will provide home visiting services with rea- sonable frequency—
p.000489: (A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches
p.000489: at least 2 years of age; and
p.000489: (B) to other eligible families, for at least 2 years; and
p.000489: (2) the entity will coordinate with public health and re- lated social service agencies to prevent duplication
p.000489: of effort and improve the delivery of comprehensive health and related so- cial services.
p.000489: (j) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may award a grant under subsection (a) only if
p.000489: the entity involved submits to the Secretary—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: 491
p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
p.000491: the entity will provide continuing training and sufficient support to the home visitors; and
...

p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
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p.000491: January 30, 2020
p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
p.000495:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000495:
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p.000495:
p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
...

p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
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p.000503: PUBLIC HEALTH SERVICE ACT
p.000503: Sec. 399A
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p.000503: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in
p.000503: obtaining the services described in subsection (b) for their children.
p.000503: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
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p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
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p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: 523
p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
p.000523: hol Effect, including programs and research concerning education and public awareness for relevant service
p.000523: pro- viders, school-age children, women at-risk, and the general public, medical diagnosis, interventions for
p.000523: women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and
p.000523: beneficial services for indi- viduals with Fetal Alcohol Syndrome and Fetal Alcohol Ef- fect and their families;
p.000523: (B) coordinate its efforts with the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the
p.000523: De- partment of Health and Human Services; and
p.000523: (C) report on a biennial basis to the Secretary and rel- evant committees of Congress on the current and planned
p.000523: activities of the participating agencies.
p.000523: (4) TIME FOR APPOINTMENT.—The members of the Task Force shall be appointed by the Secretary not later
p.000523: than 6 months after the date of enactment of this part.
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: Sec. 399I PUBLIC HEALTH SERVICE ACT 524
p.000523:
p.000523: SEC. 399I. ø280f–1¿ ELIGIBILITY.
p.000523: To be eligible to receive a grant, or enter into a cooperative agreement or contract under this part, an
p.000523: entity shall—
p.000523: (1) be a State, Indian tribal government, local government, scientific or academic institution, or nonprofit
p.000523: organization; and
p.000523: (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such
...

p.000525: as part of an ap- plication for a grant under this section how the entity will coordi- nate operations
p.000525: and activities under the grant with—
p.000525:
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p.000525: January 30, 2020
p.000525: 103 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and paragraph
p.000525: (3) probably should be redesignated as paragraphs (3) and (4), respectively. See sec- tion 501 of Public Law 106–310
p.000525: (114 Stat. 1113).
p.000525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: Sec. 399L PUBLIC HEALTH SERVICE ACT 526
p.000525:
p.000525: (1) other programs operated in the State that serve chil- dren with asthma, including any such
p.000525: programs operated under title V, XIX, or XXI of the Social Security Act; and
p.000525: (2) one or more of the following—
p.000525: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000525: such Act;
p.000525: (B) the head start program established under the Head Start Act (42 U.S.C. 9831 et seq.);
p.000525: (C) the program of assistance under the special sup- plemental nutrition program for women, infants and
p.000525: chil- dren (WIC) under section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786);
p.000525: (D) local public and private elementary or secondary schools; or
p.000525: (E) public housing agencies, as defined in section 3 of the United States Housing Act of 1937 (42
p.000525: U.S.C. 1437a).
p.000525: (c) EVALUATION.—An eligible entity that receives a grant under this section shall submit to the Secretary an evaluation
p.000525: of the oper- ations and activities carried out under the grant that includes—
p.000525: (1) a description of the health status outcomes of children assisted under the grant;
p.000525: (2) an assessment of the utilization of asthma-related health care services as a result of
p.000525: activities carried out under the grant;
p.000525: (3) the collection, analysis, and reporting of asthma data according to guidelines prescribed by the
p.000525: Director of the Cen- ters for Disease Control and Prevention; and
p.000525: (4) such other information as the Secretary may require.
p.000525: (d) PREFERENCE FOR STATES THAT ALLOW STUDENTS TO SELF- ADMINISTER MEDICATION TO TREAT ASTHMA AND
p.000525: ANAPHYLAXIS.—
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p.000104: (1) PREFERENCE.—The Secretary, in making any grant under this section or any other grant that is
p.000104: asthma-related (as determined by the Secretary) to a State, shall give pref- erence to any State that
p.000104: satisfies the following:
p.000104: (A) IN GENERAL.—The State must require that each public elementary school and secondary school in that
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p.000541: do- mestic and sexual violence;
p.000541: (ii) the development, expansion, and implementa- tion of sexual assault forensic medical examination or sexual
p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
p.000541: dress issues of confidentiality and patient safety and com- ply with applicable confidentiality and nondisclosure
p.000541: re- quirements under section 40002(b)(2) of the Violence Against Women Act of 1994 and the Family Violence
p.000541: Pre- vention and Services Act, and that faculty and staff associ- ated with delivering educational components
p.000541: are fully trained in procedures that will protect the immediate and ongoing security and confidentiality
p.000541: of the patients, pa- tient records, and staff. Such grantees shall consult enti- ties with demonstrated
p.000541: expertise in the confidentiality and safety needs of victims of domestic violence, dating vio- lence, sexual
p.000541: assault, and stalking on the development and adequacy of confidentially and security procedures, and provide
p.000541: documentation of such consultation.
p.000541: (B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.— Grantees under this section shall provide to patients
p.000541: ad- vance notice about any circumstances under which infor- mation may be disclosed, such as mandatory
p.000541: reporting laws, and shall give patients the option to receive informa- tion and referrals without affirmatively
p.000541: disclosing abuse.
p.000541: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee shall use not more than 10 percent of the amounts
p.000541: received under a grant under this section for administrative expenses.
p.000541: (3) APPLICATION.—
p.000541: (A) PREFERENCE.—In selecting grant recipients under this section, the Secretary shall give preference to
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p.000543: tic, dating or sexual violence on health behaviors, health conditions, and health status of individuals,
p.000543: families, and populations, including underserved populations;
p.000543: (B) research to determine effective health care inter- ventions to respond to and prevent domestic violence,
p.000543: dat- ing violence, sexual assault, and stalking;
p.000543: (C) research on the impact of domestic, dating and sexual violence, childhood exposure to such violence,
p.000543: and stalking on the health care system, health care utilization, health care costs, and health status; and
p.000543: (D) research on the impact of adverse childhood expe- riences on adult experience with domestic violence, dating
p.000543: violence, sexual assault, stalking, and adult health out- comes, including how to reduce or prevent the
p.000543: impact of adverse childhood experiences through the health care set- ting.
p.000543: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000543: $10,000,000 for each of fiscal years 2014 through 2018.
p.000543: (h) DEFINITIONS.—Except as otherwise provided herein, the definitions provided for in section 40002 of the
p.000543: Violence Against Women Act of 1994 shall apply to this section.
p.000543: SEC. 399Q. ø280g–4¿ PUBLIC AND HEALTH CARE PROVIDER EDU- CATION AND SUPPORT SERVICES.
p.000543: (a) IN GENERAL.—The Secretary, directly or through the awarding of grants to public or private nonprofit
p.000543: entities, may con- duct activities, which may include demonstration projects for the purpose of improving
p.000543: the provision of information on prematurity to health professionals and other health care providers and
p.000543: the public and improving the treatment and outcomes mothers of in- fants born preterm, and infants born
p.000543: preterm, as appropriate.
p.000543: (b) ACTIVITIES.—Activities to be carried out under subsection
p.000543: (a) may include the establishment of—
p.000543: (1) programs, including those to test and evaluate strate- gies, which, in collaboration with States,
p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: PUBLIC HEALTH SERVICE ACT
p.000545: Sec. 399R
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p.000545: ery;
p.000545: (A) the core risk factors for preterm labor and deliv-
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p.000551: the United States with experience serving the popu- lation of individuals with neurological disease
p.000551: and have dem- onstrated experience in neurological disease research, care, and pa- tient services.
p.000551: (k) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000551: $5,000,000 for each of fiscal years 2018 through 2022.
p.000551: SEC. 399T. ø280g–8¿ SUPPORT FOR PATIENTS RECEIVING A POSITIVE DIAGNOSIS OF DOWN SYNDROME OR OTHER PRENATALLY OR
p.000551: POSTNATALLY DIAGNOSED CONDITIONS.
p.000551: (a) DEFINITIONS.—In this section:
p.000551: (1) DOWN SYNDROME.—The term ‘‘Down syndrome’’ refers to a chromosomal disorder caused by an error in
p.000551: cell division that results in the presence of an extra whole or partial copy of chromosome 21.
p.000551: (2) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any person or entity required by State or
p.000551: Federal law or regulation to be licensed, registered, or certified to pro- vide health care services, and who is so
p.000551: licensed, registered, or certified.
p.000551: (3) POSTNATALLY DIAGNOSED CONDITION.—The term ‘‘postnatally diagnosed condition’’ means any health
p.000551: condition identified during the 12-month period beginning at birth.
p.000551: (4) PRENATALLY DIAGNOSED CONDITION.—The term ‘‘pre- natally diagnosed condition’’ means any fetal health
p.000551: condition identified by prenatal genetic testing or prenatal screening pro- cedures.
p.000551: (5) PRENATAL TEST.—The term ‘‘prenatal test’’ means diag- nostic or screening tests offered to pregnant women
p.000551: seeking routine prenatal care that are administered on a required or recommended basis by a health care
p.000551: provider based on medical history, family background, ethnic background, previous test results, or other risk
p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
p.000551:
p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
p.000551: (ii) the expansion and further development of the National Dissemination Center for Children with Dis-
p.000551: abilities, so that such Center can more effectively con- duct outreach to new and expecting parents and pro-
p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
p.000551: (2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ means—
p.000551: (A) a State or a political subdivision of a State;
p.000551: (B) a consortium of 2 or more States or political sub- divisions of States;
p.000551: (C) a territory;
p.000551: (D) a health facility or program operated by or pursu- ant to a contract with or grant from the Indian Health
p.000551: Service; or
p.000551: (E) any other entity with appropriate expertise in pre- natally and postnatally diagnosed conditions (including na-
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p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
p.000553: organizations delivering population-based services, including primary care professionals, health care
p.000553: systems, professional societies, employers, community organizations, non-profit organizations, schools,
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p.000557: January 30, 2020
p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
p.000557: (B) may include entities such as hospital associations, primary care practice-based research networks, health pro-
p.000557: fessional societies, State primary care associations, State licensing boards, organizations with a contract
p.000557: with the Secretary under section 1153 of the Social Security Act, consumer groups, and other appropriate
p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
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p.000579: needs of individuals with autism spectrum disorder and other
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: Sec. 399BB PUBLIC HEALTH SERVICE ACT 580
p.000579:
p.000579: developmental disabilities across their lifespan and the needs of their families through—
p.000579: (A) Federal programs, including—
p.000579: (i) the Head Start program;
p.000579: (ii) the Early Start program;
p.000579: (iii) the Healthy Start program;
p.000579: (iv) programs under the Child Care and Develop- ment Block Grant Act of 1990;
p.000579: (v) programs under title XIX of the Social Security Act (particularly the Medicaid Early and Periodic
p.000579: Screening, Diagnosis and Treatment Program);
p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
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p.000591: eligible hos- pitals.
p.000591: (b) REPORT TO THE SECRETARY.—As determined appropriate by the Secretary, eligible hospitals and patient
p.000591: safety organizations working with those hospitals shall report to the Secretary on the processes employed
p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
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p.000595: 595
p.000595: PUBLIC HEALTH SERVICE ACT
p.000595: Sec. 399NN
p.000595:
p.000595: (b) REPORT.—Upon the completion of each study under sub- section (a), the Director shall submit to Congress a
p.000595: report that in- cludes the recommendations of the Director for the implementation of effective employer-based health
p.000595: policies and programs.
p.000595: SEC. 399MM–2. ø280l–2¿ PRIORITIZATION OF EVALUATION BY SEC- RETARY.
p.000595: The Secretary shall evaluate, in accordance with this part, all programs funded through the Centers for
p.000595: Disease Control and Pre- vention before conducting such an evaluation of privately funded programs unless an
p.000595: entity with a privately funded wellness pro- gram requests such an evaluation.
p.000595: SEC. 399MM–3. ø280l–3¿ PROHIBITION OF FEDERAL WORKPLACE WELLNESS REQUIREMENTS.
p.000595: Notwithstanding any other provision of this part, any rec- ommendations, data, or assessments carried out
p.000595: under this part shall not be used to mandate requirements for workplace wellness programs.
p.000595:
p.000595: PART V—PROGRAMS RELATING TO BREAST HEALTH AND CANCER
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p.000595: January 30, 2020
p.000595: SEC. 399NN. ø280m¿ YOUNG WOMEN’S BREAST HEALTH AWARENESS AND SUPPORT OF YOUNG WOMEN DIAGNOSED WITH
p.000595: BREAST CANCER.
p.000595: (a) PUBLIC EDUCATION CAMPAIGN.—
p.000595: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000595: shall conduct a national evidence-based education campaign to in- crease awareness of young women’s knowledge
p.000595: regarding—
p.000595: (A) breast health in young women of all racial, ethnic, and cultural backgrounds;
p.000595: (B) breast awareness and good breast health habits;
p.000595: (C) the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk
p.000595: for breast cancer based on familial, racial, ethnic, and cul- tural backgrounds such as Ashkenazi Jewish
p.000595: populations;
p.000595: (D) evidence-based information that would encourage young women and their health care professional to in-
p.000595: crease early detection of breast cancers; and
p.000595: (E) the availability of health information and other re- sources for young women diagnosed with breast cancer.
p.000595: (2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The campaign shall provide evidence-based, age-appropriate
p.000595: mes- sages and materials as developed by the Centers for Disease Control and Prevention and the Advisory
p.000595: Committee estab- lished under paragraph (4).
p.000595: (3) MEDIA CAMPAIGN.—In conducting the education cam- paign under paragraph (1), the Secretary shall award grants
p.000595: to entities to establish national multimedia campaigns oriented to young women that may include advertising through
p.000595: television, radio, print media, billboards, posters, all forms of existing and especially emerging social networking
p.000595: media, other Internet
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: Sec. 399NN PUBLIC HEALTH SERVICE ACT 596
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p.000595: media, and any other medium determined appropriate by the Secretary.
p.000595: (4) ADVISORY COMMITTEE.—
p.000595: (A) ESTABLISHMENT.—Not later than 60 days after the date of the enactment of this section, the Secretary, acting
p.000595: through the Director of the Centers for Disease Control and Prevention, shall establish an advisory
p.000595: committee to assist in creating and conducting the education campaigns under paragraph (1) and subsection (b)(1).
p.000595: (B) MEMBERSHIP.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000595: tion, shall appoint to the advisory committee under sub- paragraph (A) such members as deemed necessary to
p.000595: prop- erly advise the Secretary, and shall include organizations and individuals with expertise in breast
p.000595: cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and
p.000595: counseling, treatment, rehabilitation, palliative care, and survivorship in young women.
p.000595: (b) HEALTH CARE PROFESSIONAL EDUCATION CAMPAIGN.—The Secretary, acting through the Director of the Centers
p.000595: for Disease Control and Prevention, and in consultation with the Administrator of the Health Resources and Services
p.000595: Administration, shall conduct an education campaign among physicians and other health care professionals to
p.000595: increase awareness—
p.000595: (1) of breast health, symptoms, and early diagnosis and treatment of breast cancer in young women,
p.000595: including specific risk factors such as family history of cancer and women that may be at high risk for
p.000595: breast cancer, such as Ashkenazi Jew- ish population;
p.000595: (2) on how to provide counseling to young women about their breast health, including knowledge of their family
p.000595: cancer history and importance of providing regular clinical breast ex- aminations;
p.000595: (3) concerning the importance of discussing healthy behav- iors, and increasing awareness of services and programs
p.000595: avail- able to address overall health and wellness, and making pa- tient referrals to address tobacco
p.000595: cessation, good nutrition, and physical activity;
p.000595: (4) on when to refer patients to a health care provider with genetics expertise;
p.000595: (5) on how to provide counseling that addresses long-term survivorship and health concerns of young women
p.000595: diagnosed with breast cancer; and
p.000595: (6) on when to provide referrals to organizations and insti- tutions that provide credible health information
p.000595: and sub- stantive assistance and support to young women diagnosed with breast cancer.
p.000595: (c) PREVENTION RESEARCH ACTIVITIES.—The Secretary, acting through—
p.000595: (1) the Director of the Centers for Disease Control and Prevention, shall conduct prevention research on
p.000595: breast cancer in younger women, including—
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: PUBLIC HEALTH SERVICE ACT
p.000597: Sec. 399NN
p.000597:
p.000597: (A) behavioral, survivorship studies, and other re- search on the impact of breast cancer diagnosis
p.000597: on young women;
p.000597: (B) formative research to assist with the development of educational messages and information for the
p.000597: public, targeted populations, and their families about breast health, breast cancer, and healthy
p.000597: lifestyles;
p.000597: (C) testing and evaluating existing and new social marketing strategies targeted at young women; and
p.000597: (D) surveys of health care providers and the public re- garding knowledge, attitudes, and practices related
p.000597: to breast health and breast cancer prevention and control in high-risk populations; and
p.000597: (2) the Director of the National Institutes of Health, shall conduct research to develop and validate
p.000597: new screening tests and methods for prevention and early detection of breast can- cer in young women.
p.000597: (d) SUPPORT FOR YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.—
p.000597: (1) IN GENERAL.—The Secretary shall award grants to or- ganizations and institutions to provide health
p.000597: information from credible sources and substantive assistance directed to young women diagnosed with breast
p.000597: cancer and pre-neoplastic breast diseases.
p.000597: (2) PRIORITY.—In making grants under paragraph (1), the Secretary shall give priority to applicants that deal
p.000597: specifically with young women diagnosed with breast cancer and pre-neo- plastic breast disease.
p.000597: (e) NO DUPLICATION OF EFFORT.—In conducting an education campaign or other program under subsections (a),
p.000597: (b), (c), or (d), the Secretary shall avoid duplicating other existing Federal breast cancer education efforts.
p.000597: (f) MEASUREMENT; REPORTING.—The Secretary, acting through the Director of the Centers for Disease
p.000597: Control and Prevention, shall—
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p.000597: January 30, 2020
p.000597: (1) measure—
p.000597: (A) young women’s awareness regarding breast health, including knowledge of family cancer history, specific risk
p.000597: factors and early warning signs, and young women’s proactive efforts at early detection;
p.000597: (B) the number or percentage of young women uti- lizing information regarding lifestyle interventions that
p.000597: foster healthy behaviors;
p.000597: (C) the number or percentage of young women receiv- ing regular clinical breast exams; and
p.000597: (D) the number or percentage of young women who perform breast self exams, and the frequency of
p.000597: such exams, before the implementation of this section;
p.000597: (2) not less than every 3 years, measure the impact of such activities; and
p.000597: (3) submit reports to the Congress on the results of such measurements.
p.000597: (g) DEFINITION.—In this section, the term ‘‘young women’’ means women 15 to 44 years of age.
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: Sec. 401 PUBLIC HEALTH SERVICE ACT 598
p.000597:
p.000597: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out sub- sections (a), (b), (c)(1), and (d), there are
p.000597: authorized to be appro- priated $4,900,000 for each of fiscal years 2015 through 2019.
p.000597: TITLE IV—NATIONAL RESEARCH INSTITUTES PART A—NATIONAL INSTITUTES OF HEALTH
p.000597: SEC. 401. ø281¿ ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.
p.000597: (a) RELATION TO PUBLIC HEALTH SERVICE.—The National Insti- tutes of Health is an agency of the Service. 1
p.000597: (b) NATIONAL RESEARCH INSTITUTES AND NATIONAL CENTERS.— The following agencies of the National Institutes of
p.000597: Health are na- tional research institutes or national centers:
p.000597: (1) The National Cancer Institute.
p.000597: (2) The National Heart, Lung, and Blood Institute.
p.000597: (3) The National Institute of Diabetes and Digestive and Kidney Diseases.
p.000597: (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
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p.000599: (23) The National Center for Complementary and Integra- tive Health.
p.000599: (24) The National Institute on Minority Health and Health Disparities.
p.000599: (25) Any other national center that, as an agency separate from any national research institute, was established
p.000599: within the National Institutes of Health as of the day before the date of the enactment of the National
p.000599: Institutes of Health Reform Act of 2006.
p.000599: (c) DIVISION OF PROGRAM COORDINATION, PLANNING, AND STRA-
p.000599: TEGIC INITIATIVES.—
p.000599: (1) IN GENERAL.—Within the Office of the Director of the National Institutes of Health, there shall be a
p.000599: Division of Pro- gram Coordination, Planning, and Strategic Initiatives (re- ferred to in this subsection
p.000599: as the ‘‘Division’’).
p.000599: (2) OFFICES WITHIN DIVISION.—
p.000599: (A) OFFICES.—The following offices are within the Di- vision: The Office of AIDS Research, the Office of
p.000599: Research on Women’s Health, the Office of Behavioral and Social Sciences Research, the Office of Disease
p.000599: Prevention, the Office of Dietary Supplements, and any other office located within the Office of the Director of
p.000599: NIH as of the day be- fore the date of the enactment of the National Institutes of Health Reform Act
p.000599: of 2006. In addition to such offices, the Director of NIH may establish within the Division such additional
p.000599: offices or other administrative units as the Di- rector determines to be appropriate.
p.000599: (B) AUTHORITIES.—Each office in the Division—
p.000599: (i) shall continue to carry out the authorities that were in effect for the office before the date of enact-
p.000599: ment referred to in subparagraph (A); and
p.000599: (ii) shall, as determined appropriate by the Direc- tor of NIH, support the Division with respect to the
p.000599: authorities described in section 402(b)(7).
p.000599: (d) ORGANIZATION.—
p.000599: (1) NUMBER OF INSTITUTES AND CENTERS.—In the National Institutes of Health, the number of national research
p.000599: institutes and national centers may not exceed a total of 27, including any such institutes or centers
p.000599: established under authority of paragraph (2) or under authority of this title as in effect on the day before the
p.000599: date of the enactment of the National Institutes of Health Reform Act of 2006.
p.000599: (2) REORGANIZATION OF INSTITUTES.—
p.000599: (A) IN GENERAL.—The Secretary may establish in the National Institutes of Health one or more additional
p.000599: na- tional research institutes to conduct and support research, training, health information, and other programs
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p.000605:
p.000605:
p.000605: January 30, 2020
p.000605: respecting the management and operation of programs and ac- tivities within the National Institutes of Health;
p.000605: (2) shall coordinate and oversee the operation of the na- tional research institutes, national centers, and
p.000605: administrative entities within the National Institutes of Health;
p.000605: (3) shall, in consultation with the heads of the national re- search institutes and national centers, be
p.000605: responsible for pro- gram coordination across the national research institutes and national centers, including
p.000605: conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is
p.000605: balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
p.000605: (4) shall assemble accurate data to be used to assess re- search priorities, including—
p.000605: (A) information to better evaluate scientific oppor- tunity, public health burdens, and progress in
p.000605: reducing health disparities; and
p.000605: (B) data on study populations of clinical research, funded by or conducted at each national research institute
p.000605: and national center, which—
p.000605: (i) specifies the inclusion of—
p.000605: (I) women;
p.000605: (II) members of minority groups;
p.000605: (III) relevant age categories, including pedi- atric subgroups; and
p.000605: (IV) other demographic variables as the Direc- tor of the National Institutes of Health determines appropriate;
p.000605: (ii) is disaggregated by research area, condition, and disease categories; and
p.000605: (iii) is to be made publicly available on the Inter- net website of the National Institutes of Health;
p.000605: (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as
p.000605: determined by the agencies of the National Institutes of Health, and through the development,
p.000605: implementation, and updating of the strategic plan developed under subsection (m);
p.000605: (6) shall ensure that the resources of the National Insti- tutes of Health are sufficiently allocated
p.000605: for research projects identified in strategic plans;
p.000605: (7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
p.000605: (i) identify research that represents important areas of emerging scientific opportunities, rising public health chal-
p.000605: lenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting
p.000605: addi- tional research that involves collaboration between 2 or more national research institutes or
p.000605: national centers, or would otherwise benefit from strategic coordination and planning;
p.000605: (ii) include information on such research in reports under section 403; and
p.000605: (iii) in the case of such research supported with funds referred to in subparagraph (B)—
...

p.000609: 3.
p.000609: (f) There shall be in the National Institutes of Health an Asso- ciate Director for Prevention. The Director of NIH
p.000609: shall delegate to the Associate Director for Prevention the functions of the Director relating to the
p.000609: promotion of the disease prevention research pro- grams of the national research institutes and the
p.000609: coordination of such programs among the national research institutes and between the national research institutes
p.000609: and other public and private enti- ties, including elementary, secondary, and post-secondary schools. The
p.000609: Associate Director shall—
p.000609: (1) annually review the efficacy of existing policies and techniques used by the national research institutes
p.000609: to dissemi- nate the results of disease prevention and behavioral research programs; and
p.000609: (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to
p.000609: ensure max- imum dissemination, using advanced technologies to the max- imum extent practicable, of research
p.000609: results to such entities. ø(g) Transferred to section 461, redesignated as subsection (b)
p.000609: of such section, and amended (as so redesignated) by section 221(b)(5) of division F of Public Law
p.000609: 112–74.¿
p.000609: (h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of
p.000609: Health, shall, in conducting and supporting programs for research, research training, recruitment, and
p.000609: other activities, provide for an increase in the number of women and individuals from disadvantaged back- grounds
p.000609: (including racial and ethnic minorities) in the fields of bio- medical and behavioral research.
p.000609: (i)(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a
p.000609: data bank of information on clinical trials for drugs for serious or life-threatening diseases
p.000609:
p.000609:
p.000609:
p.000609:
p.000609: January 30, 2020
p.000609: 3 So in law. That Act was repealed by section 251(a)(2) of Public Law 105–220 (112 Stat. 1079).
p.000609: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000609:
p.000609:
p.000609:
p.000609:
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p.000609:
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p.000609:
p.000609: Sec. 402 PUBLIC HEALTH SERVICE ACT 610
p.000609:
p.000609: and conditions (in this subsection referred to as the ‘‘data bank’’). The activities of the data bank shall
p.000609: be integrated and coordinated with related activities of other agencies of the Department of Health and Human
p.000609: Services, and to the extent practicable, coordi- nated with other data banks containing similar information.
p.000609: (B) The Secretary shall establish the data bank after consulta- tion with the Commissioner of Food and Drugs, the
p.000609: directors of the appropriate agencies of the National Institutes of Health (including the National Library of
p.000609: Medicine), and the Director of the Centers for Disease Control and Prevention.
...

p.000637: (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
p.000637: (2) for students described in paragraph (1), the average time between the beginning of graduate study
p.000637: and the receipt of a doctoral degree.
p.000637: (3) 5 PROVISION OF INFORMATION TO APPLICANTS.—Each in- stitution described in subsection (a) shall provide
p.000637: to each stu- dent submitting an application for a program of graduate study at such institution the information
p.000637: described in paragraphs (1) and (2) of such subsection with respect to the program or pro- grams to which such student
p.000637: has applied.
p.000637: DES
p.000637: SEC. 403D. ø283a–3¿ (a) The Director of NIH shall establish a program for the conduct and support of research and
p.000637: training, the dissemination of health information, and other programs with re- spect to the diagnosis and
p.000637: treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred
p.000637: to as ‘‘DES’’).
p.000637: (b) In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private
p.000637: entities representing individ- uals who have been exposed to DES, shall conduct or support pro- grams to educate
p.000637: health professionals and the public on the drug, including the importance of identifying and treating
p.000637: individuals who have been exposed to the drug.
p.000637: (c) After consultation with the Office of Research on Women’s Health, the Director of NIH, acting
p.000637: through the appropriate na- tional research institutes, shall in carrying out subsection (a) con- duct or
p.000637: support one or more longitudinal studies to determine the incidence of the following diseases or
p.000637: disorders in the indicated populations and the relationship of DES to the diseases or dis- orders:
p.000637: (1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant,
p.000637:
p.000637:
p.000637:
p.000637: January 30, 2020
p.000637: 5 So in law. Paragraph (3) probably should be subsection (b).
p.000637: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000637:
p.000637:
p.000637:
p.000637:
p.000637:
p.000637:
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p.000637:
p.000637: C:\XML\SSA-MERGED.XML
p.000637:
p.000637: Sec. 404A PUBLIC HEALTH SERVICE ACT 638
p.000637:
p.000637: the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of
p.000637: the immune system, including autoimmune disease).
p.000637: (2) In the case of women exposed to DES in utero, the inci- dence of clear cell cancer (including recurrences), the
p.000637: long-term health effects of such cancer, and the effects of treatments for such cancer.
p.000637: (3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders
p.000637: (including im- pairments of the reproductive and autoimmune systems).
p.000637: (4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and
p.000637: disorders.
p.000637: (d) For purposes of this section, an individual shall be consid- ered to have been exposed to DES in utero
p.000637: if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938)
p.000637: administered to the biological mother of the indi- vidual.
p.000637: OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH
p.000637: SEC. 404A. 6 ø283c¿ (a) There is established within the Office of the Director of NIH an office to be known
p.000637: as the Office of Behav- ioral and Social Sciences Research (in this section referred to as the ‘‘Office’’).
p.000637: The Office shall be headed by a director, who shall be appointed by the Director of NIH.
p.000637: (b)(1) With respect to research on the relationship between human behavior and the development, treatment,
p.000637: and prevention of medical conditions, the Director of the Office shall—
p.000637: (A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
p.000637: (B) identify projects of behavioral and social sciences re- search that should be conducted or supported
p.000637: by the national research institutes, and develop such projects in cooperation with such institutes.
p.000637: (2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent
p.000637: behavior, suicide, and homelessness. Such research does not include neurobiological re- search, or research
p.000637: in which the behavior of an organism is ob- served for the purpose of determining activity at the cellular or
p.000637: mo- lecular level.
...

p.000671:
p.000671:
p.000671:
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p.000671:
p.000671:
p.000671:
p.000671:
p.000671:
p.000671:
p.000671: January 30, 2020
p.000671: tional research institutes involved in research with respect to autoimmune diseases and representatives of
p.000671: all other Federal departments and agencies whose programs involve health func- tions or responsibilities relevant to
p.000671: such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.
p.000671: (3) CHAIR.—
p.000671: (A) IN GENERAL.—With respect to autoimmune dis- eases, the Chair of the Committee shall serve as the prin- cipal
p.000671: advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice
p.000671: to the Director of the Centers for Disease Control and Pre- vention, the Commissioner of Food and Drugs, and
p.000671: other relevant agencies.
p.000671: (B) DIRECTOR OF NIH.—The Chair of the Committee shall be directly responsible to the Director of NIH.
p.000671: (c) PLAN FOR NIH ACTIVITIES.—
p.000671: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Coordinating
p.000671: Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases
p.000671: through the national research institutes and shall periodically review and revise the plan. The plan shall—
p.000671: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000671: psychosocial, and rehabilitative issues, including studies of the dispropor- tionate impact of such diseases on
p.000671: women;
p.000671: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000671: regarding such diseases; and
p.000671: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000671: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to autoimmune diseases,
p.000671: provide for the following as appropriate:
p.000671: (A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
p.000671: (B) Basic research concerning the etiology and causes of the diseases.
p.000671: (C) Epidemiological studies to address the frequency and natural history of the diseases, including any
p.000671: dif- ferences among the sexes and among racial and ethnic groups.
p.000671: (D) The development of improved screening tech- niques.
p.000671: (E) Clinical research for the development and evalua- tion of new treatments, including new biological agents.
p.000671: (F) Information and education programs for health care professionals and the public.
p.000671: (3) IMPLEMENTATION OF PLAN.—The Director of NIH shall ensure that programs and activities of the National
p.000671: Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph
p.000671: (1).
p.000671: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000671:
p.000671:
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p.000671:
...

p.000685: the Congress an annual eval- uation of the efficacy of the Program and suggestions for improve- ments, and shall
p.000685: submit such other reports as the President shall direct.
p.000685:
p.000685: ASSOCIATE DIRECTOR FOR PREVENTION
p.000685: SEC. 416. ø285a–5¿ (a) There shall be in the Institute an Asso- ciate Director for Prevention to coordinate and
p.000685: promote the pro- grams in the Institute concerning the prevention of cancer. The As- sociate Director shall be
p.000685: appointed by the Director of the Institute from individuals who because of their professional training or expe- rience
p.000685: are experts in public health or preventive medicine.
p.000685: (b) The Associate Director for Prevention shall prepare for in- clusion in the biennial report made under
p.000685: section 407 a description of the prevention activities of the Institute, including a description of the staff and
p.000685: resources allocated to those activities.
p.000685:
p.000685:
p.000685:
p.000685:
p.000685:
p.000685:
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p.000685:
p.000685:
p.000685:
p.000685: January 30, 2020
p.000685: BREAST AND GYNECOLOGICAL CANCERS
p.000685: SEC. 417. ø285a–6¿ (a) EXPANSION AND COORDINATION OF AC-
p.000685: TIVITIES.—The Director of the Institute, in consultation with the National Cancer Advisory Board, shall
p.000685: expand, intensify, and co- ordinate the activities of the Institute with respect to research on breast
p.000685: cancer, ovarian cancer, and other cancers of the reproductive system of women.
p.000685: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000685: the Director under subsection (a) with similar activities conducted by other national research institutes
p.000685: and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000685: respon- sibilities that are related to breast cancer and other cancers of the reproductive system of women.
p.000685: (c) PROGRAMS FOR BREAST CANCER.—
p.000685: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000685: expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection
p.000685: shall provide for an expansion and intensification of the conduct and support of—
p.000685: (A) basic research concerning the etiology and causes of breast cancer;
p.000685: (B) clinical research and related activities concerning the causes, prevention, detection and treatment of
p.000685: breast cancer;
p.000685: (C) control programs with respect to breast cancer in accordance with section 412, including
p.000685: community-based programs designed to assist women who are members of
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000685:
p.000685:
p.000685:
p.000685:
p.000685:
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p.000685:
p.000685: Sec. 417 PUBLIC HEALTH SERVICE ACT 686
p.000685:
p.000685: medically underserved populations, low-income popu- lations, or minority groups;
p.000685: (D) information and education programs with respect to breast cancer in accordance with section 413; and
p.000685: (E) research and demonstration centers with respect to breast cancer in accordance with section 414, including the
p.000685: development and operation of centers for breast cancer re- search to bring together basic and clinical, biomedical and
p.000685: behavioral scientists to conduct basic, clinical, epidemiolog- ical, psychosocial, prevention and treatment
p.000685: research and related activities on breast cancer.
p.000685: Not less than six centers shall be operated under subpara- graph (E). Activities of such centers should
p.000685: include supporting new and innovative research and training programs for new re- searchers. Such centers shall give
p.000685: priority to expediting the transfer of research advances to clinical applications.
p.000685: (2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—
p.000685: (A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are imple-
p.000685: mented in accordance with a plan for the programs. Such plan shall include comments and recommendations
p.000685: that the Director of the Institute considers appropriate, with due consideration provided to the
p.000685: professional judgment needs of the Institute as expressed in the annual budget estimate prepared in
p.000685: accordance with section 413(9) 16. The Director of the Institute, in consultation with the National Cancer Advisory
p.000685: Board, shall periodically review and re- vise such plan.
p.000685: (B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President’s
p.000685: Cancer Panel, the Secretary and the Director of NIH.
p.000685: (C) The Director of the Institute shall submit any revi- sions of the plan to the President’s Cancer Panel, the Sec-
p.000685: retary, and the Director of NIH.
p.000685: (D) The Secretary shall provide a copy of the plan sub- mitted under subparagraph (A), and any revisions sub-
p.000685: mitted under subparagraph (C), to the Committee on En- ergy and Commerce of the House of Representatives
p.000685: and the Committee on Labor and Human Resources of the Sen- ate.
p.000685: (d) OTHER CANCERS.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support
p.000685: research on ovarian cancer and other cancers of the reproductive system of women. Ac- tivities under such
p.000685: subsection shall provide for the conduct and support of—
p.000685: (1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive
p.000685: system of women;
p.000685: (2) clinical research and related activities into the causes, prevention, detection and treatment of
p.000685: ovarian cancer and other cancers of the reproductive system of women;
p.000685:
p.000685:
p.000685:
p.000685:
p.000685: January 30, 2020
p.000685: 16 So in law. See section 401 of Public Law 103–43 (107 Stat. 153). Probably should be section ‘‘413(b)(9)’’.
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000685:
p.000685:
p.000685:
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p.000685:
p.000687: 687
p.000687: PUBLIC HEALTH SERVICE ACT
p.000687: Sec. 417A
p.000687:
p.000687: (3) control programs with respect to ovarian cancer and other cancers of the reproductive system of
p.000687: women in accord- ance with section 412;
p.000687: (4) information and education programs with respect to ovarian cancer and other cancers of the reproductive
p.000687: system of women in accordance with section 413; and
p.000687: (5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive
p.000687: system in ac- cordance with section 414.
p.000687: (e) REPORT.—The Director of the Institute shall prepare, for in- clusion in the biennial report submitted under section
p.000687: 407, a report that describes the activities of the National Cancer Institute under the research programs referred
p.000687: to in subsection (a), that shall in- clude—
p.000687: (1) a description of the research plan with respect to breast
p.000687: cancer prepared under subsection (c);
p.000687: (2) an assessment of the development, revision, and imple- mentation of such plan;
p.000687: (3) a description and evaluation of the progress made, dur- ing the period for which such report is prepared,
p.000687: in the re- search programs on breast cancer and cancers of the reproduc- tive system of women;
p.000687: (4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with
p.000687: re- spect to breast cancer and cancers of the reproductive system of women conducted and supported by
p.000687: the National Institutes of Health; and
p.000687: (5) such comments and recommendations as the Director considers appropriate.
p.000687: PROSTATE CANCER
p.000687: SEC. 417A. ø285a–7¿ (a) EXPANSION AND COORDINATION OF AC-
p.000687: TIVITIES.—The Director of the Institute, in consultation with the National Cancer Advisory Board, shall
p.000687: expand, intensify, and co- ordinate the activities of the Institute with respect to research on prostate
p.000687: cancer.
p.000687: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000687: the Director under subsection (a) with similar activities conducted by other national research institutes
p.000687: and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000687: respon- sibilities that are related to prostate cancer.
p.000687: (c) PROGRAMS.—
p.000687: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000687: expand the understanding of the cause of, and to find a cure for, pros- tate cancer. Activities under such
p.000687: subsection shall provide for an expansion and intensification of the conduct and support of—
p.000687:
p.000687:
p.000687:
p.000687: January 30, 2020
p.000687: (A) basic research concerning the etiology and causes of prostate cancer;
p.000687: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000687:
p.000687:
p.000687:
p.000687:
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p.000687:
...

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p.000703:
p.000705: 705
p.000705: PUBLIC HEALTH SERVICE ACT
p.000705: Sec. 424A
p.000705:
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p.000705:
p.000705:
p.000705:
p.000705: January 30, 2020
p.000705: (3) The Director of the National Institutes of Health (after con- sultation with the Director of the Center and the
p.000705: advisory board es- tablished under subsection (c)) shall revise the plan developed under paragraph (1) as
p.000705: appropriate.
p.000705: (e) The Director of the Center, in cooperation with the Centers for Disease Control and Prevention, is authorized to
p.000705: coordinate ac- tivities with the Department of Transportation, the Department of Defense, the Department of
p.000705: Education, the Department of Labor, and the Department of Commerce to collect data, conduct studies, and
p.000705: disseminate public information concerning the impact of sleep disorders and sleep deprivation.
p.000705: HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN
p.000705: SEC. 424A. ø285b–7a¿ (a) IN GENERAL.—The Director of the Institute shall expand, intensify, and coordinate
p.000705: research and re- lated activities of the Institute with respect to heart attack, stroke, and other cardiovascular
p.000705: diseases in women.
p.000705: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate activities under
p.000705: subsection (a) with similar activities conducted by the other national research insti- tutes and agencies
p.000705: of the National Institutes of Health to the ex- tent that such Institutes and agencies have
p.000705: responsibilities that are related to heart attack, stroke, and other cardiovascular dis- eases in women.
p.000705: (c) CERTAIN PROGRAMS.—In carrying out subsection (a), the Di- rector of the Institute shall conduct or support research
p.000705: to expand the understanding of the causes of, and to develop methods for pre- venting, cardiovascular diseases in
p.000705: women. Activities under such subsection shall include conducting and supporting the following:
p.000705: (1) Research to determine the reasons underlying the prev- alence of heart attack, stroke, and other
p.000705: cardiovascular dis- eases in women, including African-American women and other women who are members of racial
p.000705: or ethnic minority groups.
p.000705: (2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
p.000705: (3) Epidemiological studies to address the frequency and natural history of such diseases and the
p.000705: differences among men and women, and among racial and ethnic groups, with re- spect to such diseases.
p.000705: (4) The development of safe, efficient, and cost-effective di- agnostic approaches to evaluating women with
p.000705: suspected ischemic heart disease.
p.000705: (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
p.000705: (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women,
p.000705: including appli- cations of effective methods for the control of blood pressure, lipids, and obesity.
p.000705: (7) Information and education programs for patients and health care providers on risk factors associated
p.000705: with heart at- tack, stroke, and other cardiovascular diseases in women, and on the importance of the
p.000705: prevention or control of such risk fac-
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
p.000705:
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p.000705:
p.000705: Sec. 424B PUBLIC HEALTH SERVICE ACT 706
p.000705:
p.000705: tors and timely referral with appropriate diagnosis and treat- ment. Such programs shall include
p.000705: information and education on health-related behaviors that can improve such important risk factors as
p.000705: smoking, obesity, high blood cholesterol, and lack of exercise.
p.000705: COORDINATION OF FEDERAL ASTHMA ACTIVITIES
p.000705: SEC. 424B 22 ø285b–7b¿ (a) IN GENERAL.—The Director of In- stitute shall, through the National Asthma
p.000705: Education Prevention Program Coordinating Committee—
p.000705: (1) identify all Federal programs that carry out asthma-re- lated activities; and
p.000705: (2) develop, in consultation with appropriate Federal agen- cies and professional and voluntary health
p.000705: organizations, a Federal plan for responding to asthma.
p.000705: (b) REPRESENTATION OF THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT.—A representative of the
p.000705: Department of Housing and Urban Development shall be included on the National Asthma Education Prevention Program
...

p.000719: prevention, control, and treatment of, and re- habilitation of children with arthritis and musculoskeletal diseases.
p.000719:
p.000719:
p.000719: January 30, 2020 As Amended Through P.L. 116-94,
p.000719: Enacted December 20, 2019
p.000719:
p.000719:
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p.000719:
p.000719: Sec. 441A PUBLIC HEALTH SERVICE ACT 720
p.000719:
p.000719: LUPUS
p.000719: SEC. 441A. ø285d–6a¿ (a) IN GENERAL.—The Director of the Institute shall expand and intensify research and
p.000719: related activities of the Institute with respect to lupus.
p.000719: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000719: the Director under subsection (a) with similar activities conducted by the other na- tional research
p.000719: institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000719: respon- sibilities that are related to lupus.
p.000719: (c) PROGRAMS FOR LUPUS.—In carrying out subsection (a), the Director of the Institute shall conduct or
p.000719: support research to ex- pand the understanding of the causes of, and to find a cure for, lupus.
p.000719: Activities under such subsection shall include conducting and supporting the following:
p.000719: (1) Research to determine the reasons underlying the ele- vated prevalence of lupus in women, including
p.000719: African-Amer- ican women.
p.000719: (2) Basic research concerning the etiology and causes of the disease.
p.000719: (3) Epidemiological studies to address the frequency and natural history of the disease and the
p.000719: differences among the sexes and among racial and ethnic groups with respect to the disease.
p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
p.000719:
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p.000719:
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p.000719:
p.000719:
p.000719:
p.000719:
p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
...

p.000727: able to, and will, carry out the activities described in subsection (b) without a grant or contract from the Federal
p.000727: Government; and
p.000727: (3) such other information as the Director may prescribe.
p.000727: ALZHEIMER’S DISEASE REGISTRY
p.000727: SEC. 445G. ø285e–9¿ (a) IN GENERAL.—The Director of the In- stitute may make a grant to develop a registry for the
p.000727: collection of epidemiological data about Alzheimer’s disease and its incidence in the United States, to train personnel
p.000727: in the collection of such data, and for other matters respecting such disease.
p.000727: (b) QUALIFICATIONS.—To qualify for a grant under subsection
p.000727: (a) an applicant shall—
p.000727: (1) be an accredited school of medicine or public health which has expertise in the collection of
p.000727: epidemiological data about individuals with Alzheimer’s disease and in the develop- ment of disease registries, and
p.000727: (2) have access to a large patient population, including a patient population representative of
p.000727: diverse ethnic back- grounds.
p.000727:
p.000727: January 30, 2020 As Amended Through P.L. 116-94,
p.000727: Enacted December 20, 2019
p.000727:
p.000727:
p.000727:
p.000727:
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p.000727:
p.000727: Sec. 445H PUBLIC HEALTH SERVICE ACT 728
p.000727:
p.000727: AGING PROCESSES REGARDING WOMEN
p.000727: SEC. 445H. ø285e–10¿ The Director of the Institute, in addition to other special functions specified in section
p.000727: 444 and in coopera- tion with the Directors of the other national research institutes and agencies of the
p.000727: National Institutes of Health, shall conduct re- search into the aging processes of women, with particular
p.000727: emphasis given to the effects of menopause and the physiological and behav- ioral changes occurring during the
p.000727: transition from pre- to post- menopause, and into the diagnosis, disorders, and complications re- lated to aging
p.000727: and loss of ovarian hormones in women.
p.000727: SEC. 445I. ø285e–10a¿ ALZHEIMER’S CLINICAL RESEARCH AND TRAIN- ING AWARDS.
p.000727: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
p.000727: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000727: treatment of individuals with Alz- heimer’s disease.
p.000727: (b) SUPPORT OF PROMISING CLINICIANS.—In order to foster the application of the most current developments in the
p.000727: etiology, patho- genesis, diagnosis, prevention and treatment of Alzheimer’s dis- ease, amounts made
p.000727: available under this section shall be directed to the support of promising clinicians through awards for
p.000727: research, study, and practice at centers of excellence in Alzheimer’s disease research and treatment.
p.000727: (c) EXCELLENCE IN CERTAIN FIELDS.—Research shall be carried out under awards made under subsection (b) in
p.000727: environments of demonstrated excellence in neuroscience, neurobiology, geriatric medicine, and psychiatry and
p.000727: shall foster innovation and integra- tion of such disciplines or other environments determined suitable by
p.000727: the Director of the Institute.
p.000727: Subpart 6—National Institute of Allergy and Infectious Diseases
p.000727: PURPOSE OF THE INSTITUTE
p.000727: SEC. 446. ø285f¿ The general purpose of the National Institute of Allergy and Infectious Diseases is the conduct and
p.000727: support of re- search, training, health information dissemination, and other pro- grams with respect to
p.000727: allergic and immunologic diseases and dis- orders and infectious diseases, including tropical diseases.
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
p.000727:
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p.000729: tuberculosis.
p.000729: SEC. 447B. ø285f–3¿ SEXUALLY TRANSMITTED DISEASE CLINICAL RE- SEARCH AND TRAINING AWARDS.
p.000729: (a) IN GENERAL.—The Director of the Institute is authorized to establish and maintain a program to enhance and
p.000729: promote the translation of new scientific knowledge into clinical practice related to the diagnosis, care and
p.000729: treatment of individuals with sexually transmitted diseases.
p.000729: (b) SUPPORT OF PROMISING CLINICIANS.—In order to foster the application of the most current developments in the
p.000729: etiology, patho- genesis, diagnosis, prevention and treatment of sexually trans- mitted diseases, amounts
p.000729: made available under this section shall be directed to the support of promising clinicians through awards
p.000729: for research, study, and practice at centers of excellence in sexually transmitted disease research and treatment.
p.000729: (c) EXCELLENCE IN CERTAIN FIELDS.—Research shall be carried out under awards made under subsection (b) in
p.000729: environments of demonstrated excellence in the etiology and pathogenesis of sexu- ally transmitted diseases
p.000729: and shall foster innovation and integra- tion of such disciplines or other environments determined
p.000729: suitable by the Director of the Institute.
p.000729: SEC. 447C. ø285f–4¿ MICROBICIDE RESEARCH AND DEVELOPMENT.
p.000729: The Director of the Institute, acting through the head of the Division of AIDS, shall, consistent with
p.000729: the peer-review process of the National Institutes of Health, carry out research on, and devel- opment of, safe and
p.000729: effective methods for use by women to prevent the transmission of the human immunodeficiency virus, which may include
p.000729: microbicides.
p.000729: Subpart 7—Eunice Kennedy Shriver National Institute of Child Health and Human Development 31
p.000729: PURPOSE OF THE INSTITUTE
p.000729: SEC. 448. ø285g¿ The general purpose of the National Institute of Child Health and Human Development 32 (hereafter in
p.000729: this sub- part referred to as the ‘‘Institute’’) is the conduct and support of re- search, training, health
p.000729: information dissemination, and other pro- grams with respect to gynecologic health, maternal health, child
p.000729: health, intellectual disabilities, human growth and development,
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729:
p.000729: January 30, 2020
p.000729: 31 Section 1004 of Public Law 106–310 (114 Stat. 1130) authorizes the Director of the Institute to conduct a national
p.000729: longitudinal study of environmental influences (including physical, chem- ical, biological, and psychosocial) on
p.000729: children’s health and development. Subsection (d) of such section requires periodic reports to the Congress
p.000729: regarding the study. The first report is required to be submitted not later than three years after the date
p.000729: of the enactment of the Public Law, which was enacted October 17, 2000.
p.000729: 32 The probable intent of the Congress is to refer to the ‘‘Eunice Kennedy Shriver National Institute of
...

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p.000733:
p.000733:
p.000735: 735
p.000735: PUBLIC HEALTH SERVICE ACT
p.000735: Sec. 452E
p.000735:
p.000735: (2) the influence on health of factors particular to the com- munities in which the adolescents reside.
p.000735: (b) DESIGN OF STUDY.—
p.000735: (1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number
p.000735: of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall
p.000735: monitor the sub- jects throughout the period of the study to determine the health status of the
p.000735: subjects and any change in such status over time.
p.000735: (2) POPULATION-SPECIFIC ANALYSES.—The study required in subsection (a) shall be conducted with respect to
p.000735: the popu- lation of adolescents who are female, the population of adoles- cents who are male, various
p.000735: socioeconomic populations of ado- lescents, and various racial and ethnic populations of adoles- cents. The
p.000735: study shall be designed and conducted in a manner sufficient to provide for a valid analysis of whether there
p.000735: are significant differences among such populations in health status and whether and to what extent any such
p.000735: differences are due to factors particular to the populations involved.
p.000735: (c) COORDINATION WITH WOMEN’S HEALTH INITIATIVE.—With respect to the national study of women being conducted
p.000735: by the Sec- retary and known as the Women’s Health Initiative, the Secretary shall ensure that such study is
p.000735: coordinated with the component of the study required in subsection (a) that concerns adolescent fe- males,
p.000735: including coordination in the design of the 2 studies.
p.000735:
p.000735:
p.000735:
p.000735:
p.000735:
p.000735:
p.000735:
p.000735:
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p.000735:
p.000735:
p.000735:
p.000735:
p.000735: January 30, 2020
p.000735: FRAGILE X
p.000735: SEC. 452E. ø285g–9¿ (a) EXPANSION AND COORDINATION OF RE-
p.000735: SEARCH ACTIVITIES.—The Director of the Institute, after consulta- tion with the advisory council for the
p.000735: Institute, shall expand, inten- sify, and coordinate the activities of the Institute with respect to research
p.000735: on the disease known as fragile X.
p.000735: (b) RESEARCH CENTERS.—
p.000735: (1) IN GENERAL.—The Director of the Institute shall make grants or enter into contracts for the development and
p.000735: oper- ation of centers to conduct research for the purposes of improv- ing the diagnosis and treatment of, and
p.000735: finding the cure for, fragile X.
p.000735: (2) NUMBER OF CENTERS.—
p.000735: (A) IN GENERAL.—In carrying out paragraph (1), the Director of the Institute shall, to the extent that
p.000735: amounts are appropriated, and subject to subparagraph (B), provide for the establishment of at least three
p.000735: fragile X research centers.
p.000735: (B) PEER REVIEW REQUIREMENT.—The Director of the Institute shall make a grant to, or enter into a
p.000735: contract with, an entity for purposes of establishing a center under paragraph (1) only if the grant or contract
...

p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
p.000745: (6) conduct an intramural program of biomedical, behav- ioral, epidemiological, and social research,
p.000745: including research into the most effective means of treatment and service deliv- ery, and including
p.000745: research involving human subjects, which is—
p.000745: (A) located in an institution capable of providing all necessary medical care for such human subjects,
p.000745: including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and
p.000745: intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is
...

p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
p.000747: prevention of drug abuse and the treatment of drug abusers.
p.000747: (b) RESEARCH PROGRAM.—The research program established under this subpart shall encompass the social, behavioral,
p.000747: and bio- medical etiology, mental and physical health consequences, and so- cial and economic consequences of drug
p.000747: abuse. In carrying out the program, the Director of the Institute shall give special consider- ation to
p.000747: projects relating to drug abuse among women (particularly with respect to pregnant women).
p.000747:
p.000747:
p.000747:
p.000747:
p.000747:
p.000747:
p.000747:
p.000747:
p.000747: January 30, 2020
p.000747: 40 So in law. See section 16(a)(5) of Public Law 96–180 (93 Stat. 1305). The period probably should be
p.000747: ‘‘; and’’. (Section 464J formerly was section 504 of another law. The amendment made by Public Law 96–180 was directed
p.000747: to section 504 of that other law, which was Public Law 91– 616.)
p.000747: 41 So in law. See section 2(a) of Public Law 102–352 (106 Stat. 938). Section 701(1) does not provide
p.000747: a definition for the term ‘‘construction’’, but former section 701(1) did provide such a definition.
p.000747: Public Law 102–408 amended title VII generally; definitions for the title are now pro- vided in section 799, and that
p.000747: section does not define the term ‘‘construction’’.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000747:
p.000747:
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p.000747:
p.000749: 749
p.000749: PUBLIC HEALTH SERVICE ACT
p.000749: Sec. 464N
p.000749:
p.000749: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Substance Abuse and Mental Health
p.000749: Services Ad- ministration in focusing the services research activities of the Insti- tute and in disseminating the
p.000749: results of such research to health professionals and the general public.
p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
...

p.000749: including related biomedical, be- havioral, and social issues.
p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
p.000749: for drug abuse and addiction may be used for research and clinical trials relating to—
p.000749: (A) the effects of drug abuse on the human body, in- cluding the brain;
p.000749: (B) the addictive nature of drugs and how such effects differ with respect to different individuals;
p.000749: (C) the connection between drug abuse and mental health;
p.000749: (D) the identification and evaluation of the most effec- tive methods of prevention of drug abuse and addiction;
p.000749: (E) the identification and development of the most ef- fective methods of treatment of drug addiction,
p.000749: including pharmacological treatments;
p.000749: (F) risk factors for drug abuse;
p.000749: (G) effects of drug abuse and addiction on pregnant women and their fetuses; and
p.000749: (H) cultural, social, behavioral, neurological, and psy- chological reasons that individuals abuse drugs, or
p.000749: refrain from abusing drugs.
p.000749: (3) RESEARCH RESULTS.—The Director shall promptly dis- seminate research results under this subsection to
p.000749: Federal, State, and local entities involved in combating drug abuse and addiction.
p.000749:
p.000749:
p.000749:
p.000749:
p.000749:
p.000749:
p.000749: January 30, 2020
p.000749: 42 So in law. See section 123(b) of Public Law 102–321 (106 Stat. 361). The period probably should be
p.000749: ‘‘; and’’.
p.000749: 43 See footnote for section 464J(b).
p.000749: 44 Probably should be ‘‘ADDICTION’’. See section 2203 of Public Law 107–273 (116 Stat. 1794).
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000749:
p.000749:
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p.000749:
p.000751: 751
p.000751: PUBLIC HEALTH SERVICE ACT
p.000751: Sec. 464P
p.000751:
p.000751: OFFICE ON AIDS
p.000751: SEC. 464O. ø285o–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000751: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000751: with respect to AIDS research related to—
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p.000753: 753
p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
p.000753: (C) study the effects of discrimination on institutions and individuals, including majority institutions
p.000753: and indi- viduals;
p.000753: (D) support and develop research designed to elimi- nate institutional discrimination; and
p.000753: (E) provide increased emphasis on the concerns of women and minority populations in training programs,
p.000753: service delivery programs, and research endeavors of the Institute.
p.000753: ASSOCIATE DIRECTOR FOR PREVENTION
p.000753: SEC. 464S. ø285p–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000753: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000753: concerning the prevention of mental disorder. The Associate Director shall be appointed by the Director
p.000753: of the Insti- tute from individuals who because of their professional training or expertise are experts in mental
p.000753: disorder and the prevention of such.
p.000753: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000753: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000753: and resources allocated to those activities.
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p.000753: OFFICE OF RURAL MENTAL HEALTH RESEARCH
p.000753: SEC. 464T. ø285p–2¿ (a) IN GENERAL.—There is established within the Institute an office to be known as
p.000753: the Office of Rural
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000785: (i) AVAILABILITY OF RESOURCES.—After consultation with the Director of the Center, the Director of NIH
p.000785: shall ensure that re- sources of the National Institutes of Health, including laboratory and clinical
p.000785: facilities, fellowships (including research training fel- lowship and junior and senior clinical
p.000785: fellowships), and other re- sources are sufficiently available to enable the Center to appro- priately and
p.000785: effectively carry out its duties as described in sub- section (a). The Director of NIH, in coordination
p.000785: with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time
p.000785: liaisons with the Center in facilitating appro- priate coordination and scientific input.
p.000785: (j) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated
p.000785: to carry out this section for fiscal year 1999 are available for obli- gation through September 30, 2001.
p.000785: Amounts appropriated to carry out this section for fiscal year 2000 are available for obligation through
p.000785: September 30, 2001.
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000785: Sec. 486 PUBLIC HEALTH SERVICE ACT 786
p.000785:
p.000785: PART F—RESEARCH ON WOMEN’S HEALTH
p.000785: SEC. 486. ø287d¿ OFFICE OF RESEARCH ON WOMEN’S HEALTH.
p.000785: (a) ESTABLISHMENT.—There is established within the Office of the Director of NIH an office to be known as the
p.000785: Office of Research on Women’s Health (in this part referred to as the ‘‘Office’’). The Office shall be
p.000785: headed by a director, who shall be appointed by the Director of NIH and who shall report directly to the Director.
p.000785: (b) PURPOSE.—The Director of the Office shall—
p.000785: (1) identify projects of research on women’s health that should be conducted or supported by the
p.000785: national research in- stitutes;
p.000785: (2) identify multidisciplinary research relating to research on women’s health that should be so conducted
p.000785: or supported;
p.000785: (3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to
p.000785: menopause;
p.000785: (4) promote coordination and collaboration among entities conducting research identified under any of
p.000785: paragraphs (1) through (3);
p.000785: (5) encourage the conduct of such research by entities re- ceiving funds from the national research
p.000785: institutes;
p.000785: (6) recommend an agenda for conducting and supporting such research;
p.000785: (7) promote the sufficient allocation of the resources of the national research institutes for conducting and
p.000785: supporting such research;
p.000785: (8) assist in the administration of section 492B with re- spect to the inclusion of women as subjects in
p.000785: clinical research; and
p.000785: (9) prepare the report required in section 486B.
p.000785: (c) COORDINATING COMMITTEE.—
p.000785: (1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the
p.000785: Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘‘Coordinating
p.000785: Committee’’).
p.000785: (2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the
p.000785: senior-level staff designees of the Directors).
p.000785: (3) The Director of the Office shall serve as the chair of the Coordinating Committee.
p.000785: (4) With respect to research on women’s health, the Co- ordinating Committee shall assist the Director
p.000785: of the Office in—
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p.000785: (A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to
p.000785: ade- quately support the research;
p.000785: (B) identifying needs regarding the coordination of re- search activities, including intramural and
p.000785: extramural multidisciplinary activities;
p.000785: (C) supporting the development of methodologies to determine the circumstances in which obtaining data
p.000785: spe- cific to women (including data relating to the age of women and the membership of women in
p.000785: ethnic or racial
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000787: PUBLIC HEALTH SERVICE ACT
p.000787: Sec. 486
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p.000787: groups) is an appropriate function of clinical trials of treat- ments and therapies;
p.000787: (D) supporting the development and expansion of clin- ical trials of treatments and therapies for which obtaining such
p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
p.000787: Advi- sory Committee on Research on Women’s Health (in this sub- section referred to as the ‘‘Advisory
p.000787: Committee’’).
p.000787: (2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not
p.000787: officers or employees of the Federal Government. The Director of NIH shall make appointments to the Advisory
p.000787: Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical
p.000787: practice, research specialization, or professional expertise includes a significant focus on re- search on
p.000787: women’s health. A majority of the members of the Advisory Committee shall be women.
p.000787: (3) The Director of the Office shall serve as the chair of the Advisory Committee.
p.000787: (4) The Advisory Committee shall—
p.000787: (A) advise the Director of the Office on appropriate re- search activities to be undertaken by the national research
p.000787: institutes with respect to—
p.000787: (i) research on women’s health;
p.000787: (ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
p.000787: (iii) research on gender differences in disease eti- ology, course, and treatment;
p.000787: (iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and
p.000787: (v) research on women’s health conditions which require a multidisciplinary approach;
p.000787: (B) report to the Director of the Office on such re- search;
p.000787: (C) provide recommendations to such Director regard- ing activities of the Office (including
p.000787: recommendations on the development of the methodologies described in sub- section (c)(4)(C) and recommendations
p.000787: on priorities in car- rying out research described in subparagraph (A)); and
p.000787: (D) assist in monitoring compliance with section 492B regarding the inclusion of women in clinical research. (5)(A) The
p.000787: Advisory Committee shall prepare a biennial re-
p.000787: port describing the activities of the Committee, including find- ings made by the Committee regarding—
p.000787: (i) compliance with section 492B;
p.000787: (ii) the extent of expenditures made for research on women’s health by the agencies of the National
p.000787: Institutes of Health; and
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000787: Sec. 486A PUBLIC HEALTH SERVICE ACT 788
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p.000787: (iii) the level of funding needed for such research.
p.000787: (B) The report required in subparagraph (A) shall be sub- mitted to the Director of NIH for inclusion
p.000787: in the report re- quired in section 403.
p.000787: (e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The Secretary, acting through the Assistant Secretary for
p.000787: Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are
p.000787: represented among senior physi- cians and scientists of the national research institutes and among
p.000787: physicians and scientists conducting research with funds provided by such institutes, and as appropriate,
p.000787: carry out activities to in- crease the extent of such representation.
p.000787: (f) DEFINITIONS.—For purposes of this part:
p.000787: (1) The term ‘‘women’s health conditions’’, with respect to women of all age, ethnic, and racial groups, means
p.000787: all diseases, disorders, and conditions (including with respect to mental health)—
p.000787: (A) unique to, more serious, or more prevalent in women;
p.000787: (B) for which the factors of medical risk or types of medical intervention are different for women, or for
p.000787: which it is unknown whether such factors or types are different for women; or
p.000787: (C) with respect to which there has been insufficient clinical research involving women as subjects or
p.000787: insuffi- cient clinical data on women.
p.000787: (2) The term ‘‘research on women’s health’’ means research on women’s health conditions, including research on
p.000787: preventing such conditions.
p.000787: SEC. 486A. ø287d–1¿ NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.
p.000787: (a) DATA SYSTEM.—
p.000787: (1) The Director of NIH, in consultation with the Director of the Office and the Director of the National
p.000787: Library of Medi- cine, shall establish a data system for the collection, storage, analysis, retrieval, and
p.000787: dissemination of information regarding research on women’s health that is conducted or supported by the
p.000787: national research institutes. Information from the data sys- tem shall be available through information systems
p.000787: available to health care professionals and providers, researchers, and members of the public.
p.000787: (2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental
p.000787: treatments that have been developed for research on women’s health. Such registry shall include information on subject
p.000787: eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal
p.000787: investigators of such clinical trials shall provide this information to the registry within 30 days after it is avail-
p.000787: able. Once a trial has been completed, the principal investi- gator shall provide the registry with
p.000787: information pertaining to the results, including potential toxicities or adverse effects as- sociated with the
p.000787: experimental treatment or treatments evalu- ated.
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000789: PUBLIC HEALTH SERVICE ACT
p.000789: Sec. 487
p.000789:
p.000789: (b) CLEARINGHOUSE.—The Director of NIH, in consultation with the Director of the Office and with
p.000789: the National Library of Medicine, shall establish, maintain, and operate a program to pro- vide information on
p.000789: research and prevention activities of the na- tional research institutes that relate to research on
p.000789: women’s health.
p.000789: SEC. 486B. ø287d–2¿ BIENNIAL REPORT.
p.000789: (a) IN GENERAL.—With respect to research on women’s health, the Director of the Office shall, not later than
p.000789: February 1, 1994, and biennially thereafter, prepare a report—
p.000789: (1) describing and evaluating the progress made during the preceding 2 fiscal years in research and
p.000789: treatment con- ducted or supported by the National Institutes of Health;
p.000789: (2) describing and analyzing the professional status of women physicians and scientists of such
p.000789: Institutes, including the identification of problems and barriers regarding advance- ments;
p.000789: (3) summarizing and analyzing expenditures made by the agencies of such Institutes (and by such Office) during
p.000789: the pre- ceding 2 fiscal years; and
p.000789: (4) making such recommendations for legislative and ad- ministrative initiatives as the Director of the Office
p.000789: determines to be appropriate.
p.000789: (b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR OF NIH.—The Director of the Office shall submit each report
p.000789: prepared under sub- section (a) to the Director of NIH for inclusion in the report sub- mitted to the
p.000789: President and the Congress under section 403.
p.000789: PART G—AWARDS AND TRAINING
p.000789: RUTH L. KIRSCHSTEIN NATIONAL RESEARCH SERVICE AWARDS 51
p.000789: SEC. 487. ø288¿ (a)(1) The Secretary shall—
p.000789: (A) provide Ruth L. Kirschstein National Research Service Awards 52 for—
p.000789: (i) biomedical and behavioral research at the National Institutes of Health in matters relating to the cause, diag-
p.000789: nosis, prevention, and treatment of the diseases or other health problems to which the activities of the
p.000789: National In- stitutes of Health and Administration 53 are directed;
p.000789: (ii) training at the National Institutes of Health and at the Administration 53 of individuals to
p.000789: undertake such research;
p.000789: (iii) biomedical and behavioral research and health services research (including research in primary
p.000789: medical care) at public and nonprofit private entities; and
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p.000789: 51 The typeface is so in law. See section 804(b) of Public Law 107–206 (116 Stat. 874).
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p.000789:
p.000789: (iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake
p.000789: bio- medical and behavioral research;
p.000789: (B) make grants to public and nonprofit private institu- tions to enable such institutions to make Ruth
p.000789: L. Kirschstein National Research Service Awards for research (and training to undertake biomedical and
p.000789: behavioral research) in the mat- ters described in subparagraph (A)(i) to individuals selected by such
p.000789: institutions; and
p.000789: (C) provide contracts for scholarships and loan repayments in accordance with sections 487D and 487E, subject
p.000789: to pro- viding not more than an aggregate 50 such contracts during the fiscal years 1994 through 1996.
p.000789: A reference in this subsection to the National Institutes of Health shall be considered to include the
p.000789: institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the
p.000789: Administration, 53 as the case may be.
p.000789: (2) Ruth L. Kirschstein National Research Service Awards may not be used to support residency training of
p.000789: physicians and other health professionals.
p.000789: (3) In awarding Ruth L. Kirschstein National Research Service Awards under this section, the Secretary shall take
p.000789: account of the Nation’s overall need for biomedical research personnel by giving special consideration to
p.000789: physicians who agree to undertake a min- imum of two years of biomedical research.
p.000789: (4) The Secretary shall carry out paragraph (1) in a manner that will result in the recruitment of women, and
p.000789: individuals from disadvantaged backgrounds (including racial and ethnic minori- ties), into fields of
p.000789: biomedical or behavioral research and in the provision of research training to women and such individuals.
p.000789: (b)(1) No Ruth L. Kirschstein National Research Service Award may be made by the Secretary to any individual unless—
p.000789: (A) the individual has submitted to the Secretary an appli- cation therefor and the Secretary has approved the
p.000789: application;
p.000789: (B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe,
p.000789: assurances satis- factory to the Secretary that the individual will meet the serv- ice requirement of subsection (c);
p.000789: and
p.000789: (C) in the case of a Ruth L. Kirschstein National Research Service Award for a purpose described in
p.000789: subsection (a)(1)(A)(iii), the individual has been sponsored (in such man- ner as the Secretary may by
p.000789: regulation require) by the institu- tion at which the research or training under the award will be conducted.
p.000789: An application for an award shall be in such form, submitted in such manner, and contain such
p.000789: information, as the Secretary may by regulation prescribe.
p.000789: (2) The making of grants under subsection (a)(1)(B) for Ruth
p.000789: L. Kirschstein National Research Service Awards shall be subject to review and approval by the appropriate
p.000789: advisory councils within the Department of Health and Human Services (A) whose activities relate to the research or
p.000789: training under the awards, or (B) for the entity at which such research or training will be conducted.
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p.000799: applicable on the date of the date of enactment of the Health Research Ex- tension Act of 1985 to grants
p.000799: under this Act for biomedical and behavioral research, and
p.000799: (B) to the extent practical, by technical and scientific peer review groups performing such review on or before
p.000799: such date, and shall authorize such review to be conducted by groups ap-
p.000799: pointed under sections 402(b)(16) and 405(c)(3).
p.000799: (b) The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the
p.000799: National In- stitutes of Health. Such procedures shall require that—
p.000799: (1) the reviewing entity be provided a written description of the research to be reviewed, and
p.000799: (2) the reviewing entity provide the advisory council of the national research institute involved with such
p.000799: description and the results of the review by the entity,
p.000799: and shall authorize such review to be conducted by groups ap- pointed under sections 402(b)(6) and 405(c)(3).
p.000799: (c)(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration
p.000799: of any such pro- posal (including the initial consideration) shall, except as provided in paragraph (2), include an
p.000799: evaluation of the technical and sci- entific merit of the proposal regarding compliance with section
p.000799: 492B.
p.000799: (2) Paragraph (1) shall not apply to any proposal for clinical re- search that, pursuant to subsection (b) of section
p.000799: 492B, is not sub- ject to the requirement of subsection (a) of such section regarding the inclusion of women
p.000799: and members of minority groups as subjects in clinical research.
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p.000799: CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH
p.000799: SEC. 492A. ø289a–1¿ (a) REVIEW AS PRECONDITION TO RE-
p.000799: SEARCH.—
p.000799: (1) PROTECTION OF HUMAN RESEARCH SUBJECTS.—
p.000799: (A) In the case of any application submitted to the Secretary for financial assistance to conduct
p.000799: research, the Secretary may not approve or fund any application that is subject to review under section 491(a)
p.000799: by an Institutional Review Board unless the application has undergone review in accordance with such section
p.000799: and has been rec- ommended for approval by a majority of the members of the Board conducting such
p.000799: review.
p.000799: (B) In the case of research that is subject to review under procedures established by the Secretary for the
p.000799: pro- tection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary
p.000799: may not authorize the conduct of the research unless the research has, pursuant to such procedures, been
p.000799: recommended for approval.
p.000799: (2) PEER REVIEW.—In the case of any proposal for the Na- tional Institutes of Health to conduct or support
p.000799: research, the
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p.000801: access to all relevant information possessed by the Department of Health and Human Services, or available to
p.000801: the Secretary from other agencies.
p.000801: (I) Members of an ethics board shall receive compensa- tion for each day engaged in carrying out the duties of the
p.000801: board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an
p.000801: amount in excess of the maximum rate of basic pay pay- able for GS–18 of the General Schedule.
p.000801: (J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to
p.000801: each ethics board reasonable staff and assistance to carry out the du- ties of the board.
p.000801: (K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph
p.000801: (B)(ii) is submitted to the Secretary and the congressional com- mittees specified in such subparagraph.
p.000801: (6) DEFINITION.—For purposes of this subsection, the term ‘‘ethical considerations’’ means considerations as to
p.000801: whether the nature of the research involved is such that it is unethical to conduct or support the research.
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p.000801: January 30, 2020
p.000801: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH
p.000801: SEC. 492B. ø289a–2¿ (a) REQUIREMENT OF INCLUSION.—
p.000801: (1) IN GENERAL.—In conducting or supporting clinical re- search for purposes of this title, the Director of NIH
p.000801: shall, sub- ject to subsection (b), ensure that—
p.000801: (A) women are included as subjects in each project of such research; and
p.000801: (B) members of minority groups are included as sub- jects in such research.
p.000801: (2) OUTREACH REGARDING PARTICIPATION AS SUBJECTS.— The Director of NIH, in consultation with the
p.000801: Director of the Office of Research on Women’s Health and the Director of the Office of Research on Minority Health,
p.000801: shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects
p.000801: in projects of clinical research.
p.000801: (3) STRATEGIC PLANNING.—
p.000801: (A) IN GENERAL.—The directors of the national insti- tutes and national centers shall consult at least once
p.000801: annu- ally with the Director of the National Institute on Minority Health and Health Disparities and the Director of
p.000801: the Of- fice of Research on Women’s Health regarding objectives of the national institutes and national centers to
p.000801: ensure that future activities by such institutes and centers take into
p.000801: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000801:
p.000801:
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p.000803: 803
p.000803: PUBLIC HEALTH SERVICE ACT
p.000803: Sec. 492B
p.000803:
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p.000803: account women and minorities and are focused on reducing health disparities.
p.000803: (B) STRATEGIC PLANS.—Any strategic plan issued by a national institute or national center shall include details
p.000803: on the objectives described in subparagraph (A).
p.000803: (b) INAPPLICABILITY OF REQUIREMENT.—The requirement estab- lished in subsection (a) regarding women and members of
p.000803: minority groups shall not apply to a project of clinical research if the inclu- sion, as subjects in the project, of
p.000803: women and members of minority groups, respectively—
p.000803: (1) is inappropriate with respect to the health of the sub- jects;
p.000803: (2) is inappropriate with respect to the purpose of the re- search; or
p.000803: (3) is inappropriate under such other circumstances as the Director of NIH may designate.
p.000803: (c) DESIGN OF CLINICAL TRIALS.—
p.000803: (1) IN GENERAL.—In the case of any clinical trial in which women or members of minority groups will under
p.000803: subsection
p.000803: (a) be included as subjects, the Director of NIH shall ensure that the trial is designed and carried
p.000803: out in a manner suffi- cient to provide for a valid analysis of whether the variables being studied in
p.000803: the trial affect women or members of minority groups, as the case may be, differently than other subjects in
p.000803: the trial.
p.000803: (2) REPORTING REQUIREMENTS.—For any new and com- peting project of clinical research subject to the
p.000803: requirements under this section that receives a grant award 1 year after the date of enactment of the 21st
p.000803: Century Cures Act, or any date thereafter, for which a valid analysis is provided under para- graph (1)—
p.000803: (A) and which is an applicable clinical trial as defined in section 402(j), the entity conducting such clinical
p.000803: re- search shall submit the results of such valid analysis to the clinical trial registry data bank
p.000803: expanded under sec- tion 402(j)(3), and the Director of the National Institutes of Health shall, as
p.000803: appropriate, consider whether such en- tity has complied with the reporting requirement described in this subparagraph
p.000803: in awarding any future grant to such entity, including pursuant to section 402(j)(5)(A)(ii) when applicable; and
p.000803: (B) the Director of the National Institutes of Health shall encourage the reporting of the results of
p.000803: such valid analysis described in paragraph (1) through any additional means determined appropriate by the Director.
p.000803: (d) GUIDELINES.—
p.000803: (1) IN GENERAL.—Subject to paragraph (2), the Director of NIH, in consultation with the Director of the Office of
p.000803: Research on Women’s Health and the Director of the Office of Research on Minority Health, shall establish guidelines
p.000803: regarding the re- quirements of this section. The guidelines shall include guide- lines regarding—
p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000803: Sec. 492B PUBLIC HEALTH SERVICE ACT 804
p.000803: (A) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical re-
p.000803: search is inappropriate for purposes of subsection (b);
p.000803: (B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c); and
p.000803:
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p.000803: (C) the operation of outreach programs under sub- section (a).
p.000803: (2) CERTAIN PROVISIONS.—With respect to the cir- cumstances under which the inclusion of women or
p.000803: members of minority groups (as the case may be) as subjects in a project of clinical research is
p.000803: inappropriate for purposes of subsection (b), the following applies to guidelines under paragraph (1):
p.000803: (A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the
p.000803: trial is not a permissible consideration in determining whether such inclusion is inappropriate.
p.000803: (ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such
p.000803: inclusion in the project is not a permissible consideration in deter- mining whether such inclusion is
p.000803: inappropriate unless the data regarding women or members of minority groups, re- spectively, that would be obtained
p.000803: in such project (in the event that such inclusion were required) have been or are being obtained through other
p.000803: means that provide data of comparable quality.
p.000803: (B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is
p.000803: not required if there is substantial scientific data demonstrating that there is no significant
p.000803: difference between—
p.000803: (i) the effects that the variables to be studied in the trial have on women or members of
p.000803: minority groups, respectively; and
p.000803: (ii) the effects that the variables have on the indi- viduals who would serve as subjects in the trial in the event
p.000803: that such inclusion were not required.
p.000803: (e) DATE CERTAIN FOR GUIDELINES; APPLICABILITY.—
p.000803: (1) DATE CERTAIN.—The guidelines required in subsection
p.000803: (d) shall be established and published in the Federal Register not later than 180 days after the date of the
p.000803: enactment of the National Institutes of Health Revitalization Act of 1993.
p.000803: (2) APPLICABILITY.—For fiscal year 1995 and subsequent fiscal years, the Director of NIH may not approve any
p.000803: proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health
p.000803: unless the proposal speci- fies the manner in which the research will comply with this section.
p.000803: (f) REPORTS BY ADVISORY COUNCILS.—
p.000803: (1) IN GENERAL.—The advisory council of each national re- search institute shall prepare triennial reports
p.000803: describing the manner in which the institute has complied with this section. Each such report shall be
p.000803: submitted to the Director of the in- stitute involved for inclusion in the triennial report under sec- tion 403.
p.000803: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000805: PUBLIC HEALTH SERVICE ACT
p.000805: Sec. 493
p.000805:
p.000805: (2) CONTENTS.—Each triennial report prepared by an advi- sory council of each national research institute as described
p.000805: in paragraph (1) shall include each of the following:
p.000805: (A) The number of women included as subjects, and the proportion of subjects that are women, in any
p.000805: project of clinical research conducted during the applicable report- ing period, disaggregated by categories of
p.000805: research area, condition, or disease, and accounting for single-sex studies.
p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
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p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
p.000805: (1) ESTABLISHMENT OF OFFICE.—Not later than 90 days after the date of enactment of this section, the Secretary
p.000805: shall establish an office to be known as the Office of Research Integ- rity (referred to in this section as the
p.000805: ‘‘Office’’), which shall be established as an independent entity in the Department of Health and Human
p.000805: Services.
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p.000829: Treatment Policy, shall develop, and periodically review and as appro- priate revise, a plan for programs and policies
p.000829: to treat and prevent alcoholism and alcohol abuse. The plan shall be developed (and reviewed and revised) in
p.000829: collaboration with the Directors of the Centers of the Administration and in consultation with members of
p.000829: other Federal agencies and public and private entities.
p.000829: (B) Not later than 1 year after the date of the enact- ment of the ADAMHA Reorganization Act, the
p.000829: Assistant Secretary shall submit to the Congress the first plan devel- oped under subparagraph (A).
p.000829: (3) REPORT.—
p.000829: (A) Not less than once during each 2 years, the Assist- ant Secretary, acting through the Associate Administrator for
p.000829: Alcohol Prevention and Treatment Policy, shall prepare a report describing the alcoholism and alcohol abuse
p.000829: pre- vention and treatment programs undertaken by the Ad- ministration and its agencies, and the report shall
p.000829: include a detailed statement of the expenditures made for the ac- tivities reported on and the personnel
p.000829: used in connection with such activities.
p.000829: (B) Each report under subparagraph (A) shall include a description of any revisions in the plan under paragraph
p.000829: (2) made during the preceding 2 years.
p.000829: (C) Each report under subparagraph (A) shall be sub- mitted to the Assistant Secretary for inclusion in the bien- nial
p.000829: report under subsection (m).
p.000829: (f) ASSOCIATE ADMINISTRATOR FOR WOMEN’S SERVICES.—
p.000829: (1) APPOINTMENT.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint an Associate
p.000829: Adminis- trator for Women’s Services who shall report directly to the As- sistant Secretary.
p.000829: (2) DUTIES.—The Associate Administrator appointed under paragraph (1) shall—
p.000829: (A) establish a committee to be known as the Coordi- nating Committee for Women’s Services (hereafter in
p.000829: this subparagraph referred to as the ‘‘Coordinating Com- mittee’’), which shall be composed of the
p.000829: Directors of the agencies of the Administration (or the designees of the Di- rectors);
p.000829: (B) acting through the Coordinating Committee, with respect to women’s substance abuse and mental health
p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
p.000829: ferred to in paragraph (3)), and report biannually to the Assistant Secretary regarding the extent to which
p.000829: women are represented among senior personnel, and make recommendations regarding improvement in the participation
p.000829: of women in the workforce of the Admin- istration; and
p.000829: (iii) prepare, for inclusion in the biennial report required pursuant to subsection (m), a description of
p.000829: activities of the Committee, including findings made by the Committee regarding—
p.000829: (I) the extent of expenditures made for wom- en’s substance abuse and mental health services by the
p.000829: agencies of the Administration; and
p.000829: (II) the estimated level of funding needed for substance abuse and mental health services to meet the
p.000829: needs of women;
p.000829: (D) improve the collection of data on women’s health by—
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p.000829: (i) reviewing the current data at the Administra- tion to determine its uniformity and applicability;
p.000829: (ii) developing standards for all programs funded by the Administration so that data are, to the extent
p.000829: practicable, collected and reported using common re- porting formats, linkages and definitions; and
p.000829: (iii) reporting to the Assistant Secretary a plan for incorporating the standards developed under clause
p.000829: (ii) in all Administration programs and a plan to as- sure that the data so collected are accessible to health
p.000829: professionals, providers, researchers, and members of the public; and
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: PUBLIC HEALTH SERVICE ACT
p.000831: Sec. 501
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p.000831: (E) shall establish, maintain, and operate a program to provide information on women’s substance abuse
p.000831: and mental health services.
p.000831: (3) STUDY.—
p.000831: (A) The Secretary, acting through the Assistant Sec- retary for Personnel, shall conduct a study to evaluate the
p.000831: extent to which women are represented among senior per- sonnel at the Administration.
p.000831: (B) Not later than 90 days after the date of the enact- ment of the ADAMHA Reorganization Act, the Assistant
p.000831: Secretary for Personnel shall provide the Advisory Com- mittee for Women’s Services with a study plan,
p.000831: including the methodology of the study and any sampling frames. Not later than 180 days after such date of
p.000831: enactment, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report
p.000831: concerning the results of the study conducted under subparagraph (A).
p.000831: (C) The Secretary shall prepare and provide to the Ad- visory Committee for Women’s Services any additional
p.000831: data as requested.
p.000831: (4) OFFICE.—Nothing in this subsection shall be construed to preclude the Secretary from establishing within the
p.000831: Sub- stance Abuse and Mental Health Administration an Office of Women’s Health.
p.000831: (5) DEFINITION.—For purposes of this subsection, the term ‘‘women’s substance abuse and mental health conditions’’,
p.000831: with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental
p.000831: illness—
p.000831: (A) unique to or more prevalent among women; or
p.000831: (B) with respect to which there have been insufficient services involving women or insufficient data.
p.000831: (g) CHIEF MEDICAL OFFICER.—
p.000831: (1) IN GENERAL.—The Assistant Secretary, with the ap- proval of the Secretary, shall appoint a Chief
p.000831: Medical Officer to serve within the Administration.
p.000831: (2) ELIGIBLE CANDIDATES.—The Assistant Secretary shall select the Chief Medical Officer from among individuals
p.000831: who—
p.000831: (A) have a doctoral degree in medicine or osteopathic medicine;
p.000831: (B) have experience in the provision of mental or sub- stance use disorder services;
p.000831: (C) have experience working with mental or substance use disorder programs;
p.000831: (D) have an understanding of biological, psychosocial, and pharmaceutical treatments of mental or substance use
p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
p.000847: (5) collaborate with the Director of the National Institute on Drug Abuse, with the Director of the
p.000847: National Institute on Alcohol Abuse and Alcoholism, and with the States to promote the study, dissemination, and
p.000847: implementation of research find- ings that will improve the delivery and effectiveness of treat- ment
p.000847: services;
p.000847: (6) collaborate with the Administrator of the Health Re- sources and Services Administration and the
p.000847: Administrator of the Centers for Medicare & Medicaid Services to promote the increased integration into
p.000847: the mainstream of the health care system of the United States of programs for providing treat- ment
p.000847: services;
p.000847: (7) evaluate plans submitted by the States pursuant to sec- tion 1932(a)(6) in order to determine whether the
p.000847: plans ade- quately provide for the availability, allocation, and effective- ness of treatment services;
p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
p.000847: private entities;
p.000847: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000847: of grantees after such grants are awarded;
p.000847: (14) work with States, providers, and individuals in recov- ery, and their families, to promote the expansion
p.000847: of recovery support services and systems of care oriented toward recovery;
p.000847: (15) in cooperation with the Secretary, implement and dis- seminate, as appropriate, the recommendations in the
p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
p.000849: consultation with the women, prepare an individualized plan for the provi- sion of services for the woman and
p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
p.000849: (A) individual, group, and family counseling, as appro- priate, regarding substance use disorders; and
p.000849: (B) follow-up services to assist the woman in pre- venting a relapse into such a disorder.
p.000849: (d) REQUIRED SUPPLEMENTAL SERVICES.—In the case of an eli- gible woman, the services referred to in subsection (a)(3)
p.000849: are as fol- lows:
p.000849:
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p.000849: January 30, 2020
p.000849: (1) Prenatal and postpartum health care.
p.000849: (2) Referrals for necessary hospital services.
p.000849: (3) For the infants and children of the woman—
p.000849: (A) pediatric health care, including treatment for any perinatal effects of a maternal substance use disorder
p.000849: and including screenings regarding the physical and mental de- velopment of the infants and children;
p.000849: (B) counseling and other mental health services, in the case of children; and
p.000849: (C) comprehensive social services.
p.000849: (4) Providing therapeutic, comprehensive child care for children during the periods in which the woman is engaged
...

p.000851: the award.
p.000851: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required in paragraph (1) may be in cash or
p.000851: in kind, fairly evaluated, including plant, equipment, or serv- ices. Amounts provided by the Federal
p.000851: Government, or services assisted or subsidized to any significant extent by the Federal
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000851:
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p.000851: Sec. 508 PUBLIC HEALTH SERVICE ACT 852
p.000851:
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p.000851: January 30, 2020
p.000851:
p.000851: Government, may not be included in determining the amount of such non-Federal contributions.
p.000851: (g) OUTREACH.—A funding agreement for an award under sub- section (a) for an applicant is that the applicant
p.000851: will provide out- reach services in the community involved to identify women who have a substance use
p.000851: disorder and to encourage the women to un- dergo treatment for such disorder.
p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
p.000851: (3) will not be imposed on any such woman with an income of less than 185 percent of the official poverty
p.000851: line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000851: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000851: (k) REPORTS TO DIRECTOR.—A funding agreement for an award under subsection (a) is that the applicant involved
p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
p.000851: (3) providing such other information as the Director deter- mines to be appropriate.
p.000851: (l) REQUIREMENT OF APPLICATION.—The Director may make an award under subsection (a) only if an application for
p.000851: the award is submitted to the Director containing such agreements, and the ap- plication is in such form, is
p.000851: made in such manner, and contains such other agreements and such assurances and information as the Director
p.000851: determines to be necessary to carry out this section.
p.000851: (m) ALLOCATION OF AWARDS.—In making awards under sub- section (a), the Director shall give priority to
p.000851: an applicant that agrees to use the award for a program serving an area that is a rural area, an area
p.000851: designated under section 332 by the Secretary as a health professional shortage area, or an area
p.000851: determined by
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000853: 853
p.000853: PUBLIC HEALTH SERVICE ACT
p.000853: Sec. 508
p.000853:
p.000853: the Director to have a shortage of family-based substance use dis- order treatment options.
p.000853: (n) DURATION OF AWARD.—The period during which payments are made to an entity from an award under subsection
...

p.000853: subsection (a).
p.000853:
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p.000853: January 30, 2020
p.000853: (3) The term ‘‘funding agreement’’, with respect to an award under subsection (a), means that the Director may
p.000853: make the award only if the applicant makes the agreement involved.
p.000853: (4) The term ‘‘treatment services’’ means treatment for a substance use disorder, including the counseling
p.000853: and services described in subsection (c)(2).
p.000853: (5) The term ‘‘supplemental services’’ means the services described in subsection (d).
p.000853: (r) PILOT PROGRAM FOR STATE SUBSTANCE ABUSE AGENCIES.—
p.000853: (1) IN GENERAL.—From amounts made available under subsection (s), the Director of the Center for
p.000853: Substance Abuse Treatment shall carry out a pilot program under which com- petitive grants are made by
p.000853: the Director to State substance abuse agencies—
p.000853: (A) to enhance flexibility in the use of funds designed to support family-based services for
p.000853: pregnant and postpartum women with a primary diagnosis of a sub- stance use disorder, including opioid use
p.000853: disorders;
p.000853: (B) to help State substance abuse agencies address identified gaps in services furnished to such women
p.000853: along
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000853:
p.000853:
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p.000853: Sec. 508 PUBLIC HEALTH SERVICE ACT 854
p.000853:
p.000853: the continuum of care, including services provided to women in nonresidential-based settings; and
p.000853: (C) to promote a coordinated, effective, and efficient State system managed by State substance abuse
p.000853: agencies by encouraging new approaches and models of service de- livery.
p.000853: (2) REQUIREMENTS.—In carrying out the pilot program under this subsection, the Director shall—
p.000853: (A) require State substance abuse agencies to submit to the Director applications, in such form and manner and
p.000853: containing such information as specified by the Director, to be eligible to receive a grant under the program;
p.000853: (B) identify, based on such submitted applications, State substance abuse agencies that are eligible for
p.000853: such grants;
p.000853: (C) require services proposed to be furnished through such a grant to support family-based treatment and
p.000853: other services for pregnant and postpartum women with a pri- mary diagnosis of a substance use
p.000853: disorder, including opioid use disorders;
p.000853: (D) not require that services furnished through such a grant be provided solely to women that reside in facilities;
p.000853: (E) not require that grant recipients under the pro- gram make available through use of the grant all the serv-
p.000853: ices described in subsection (d); and
p.000853: (F) consider not applying the requirements described in paragraphs (1) and (2) of subsection (f) to an applicant,
p.000853: depending on the circumstances of the applicant.
p.000853: (3) REQUIRED SERVICES.—
p.000853: (A) IN GENERAL.—The Director shall specify a min- imum set of services required to be made available to eligi-
p.000853: ble women through a grant awarded under the pilot pro- gram under this subsection. Such minimum set of
p.000853: serv- ices—
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p.000853: January 30, 2020
p.000853: (i) shall include the services requirements de- scribed in subsection (c) and be based on the rec-
p.000853: ommendations submitted under subparagraph (B); and
p.000853: (ii) may be selected from among the services de- scribed in subsection (d) and include other services as
p.000853: appropriate.
p.000853: (B) STAKEHOLDER INPUT.—The Director shall convene and solicit recommendations from stakeholders, including
p.000853: State substance abuse agencies, health care providers, per- sons in recovery from substance abuse, and other
p.000853: appro- priate individuals, for the minimum set of services de- scribed in subparagraph (A).
p.000853: (4) DURATION.—The pilot program under this subsection shall not exceed 5 years.
p.000853: (5) EVALUATION AND REPORT TO CONGRESS.—
p.000853: (A) IN GENERAL.—The Director of the Center for Be- havioral Health Statistics and Quality shall evaluate
p.000853: the pilot program at the conclusion of the first grant cycle funded by the pilot program.
p.000853: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000853:
p.000853:
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p.000857: demonstration projects.
p.000857: SEC. 514. ø290bb–7¿ SUBSTANCE USE DISORDER TREATMENT AND EARLY INTERVENTION SERVICES FOR CHILDREN,
p.000857: ADO- LESCENTS, AND YOUNG ADULTS.
p.000857: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000857: nonprofit entities, including Indian tribes or tribal organizations (as such terms are defined in section
p.000857: 4 of the Indian Self-Determination and Edu- cation Assistance Act), or health facilities or programs operated by
p.000857: or in accordance with a contract or grant with the Indian Health Service, for the purpose of—
p.000857: (1) providing early identification and services to meet the needs of children, adolescents, and young
p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
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p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000861:
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p.000873: children and adults with fetal alcohol syndrome or alcohol-related birth de- fects and their families;
p.000873: (2) identify communities which have an exemplary com- prehensive system of care for such individuals so that
p.000873: they can provide technical assistance to other communities attempting to set up such a system of care;
p.000873: (3) provide technical assistance to communities who do not have a comprehensive system of care for such
p.000873: individuals and their families;
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000873:
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p.000873:
p.000873: (4) train community leaders, mental health and substance abuse professionals, families, law enforcement
p.000873: personnel, judges, health professionals, persons working in financial as- sistance programs, social service
p.000873: personnel, child welfare pro- fessionals, and other service providers on the implications of fetal alcohol
p.000873: syndrome and alcohol-related birth defects, the early identification of and referral for such conditions;
p.000873: (5) develop innovative techniques for preventing alcohol use by women in child bearing years; 9
p.000873: (6) perform other functions, to the extent authorized by the Secretary after consideration of recommendations made by
p.000873: the National Task Force on Fetal Alcohol Syndrome.
p.000873: (c) REPORT.—
p.000873: (1) IN GENERAL.—A recipient of an award under subsection
p.000873: (a) shall at the end of the period of funding report to the Sec- retary on any innovative techniques that have been
p.000873: discovered for preventing alcohol use among women of child bearing years.
p.000873: (2) DISSEMINATION OF FINDINGS.—The Secretary shall upon receiving a report under paragraph (1) disseminate the
p.000873: find- ings to appropriate public and private entities.
p.000873: (d) DURATION OF AWARDS.—With respect to an award under subsection (a), the period during which
p.000873: payments under such award are made to the recipient may not exceed 5 years.
p.000873: (e) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a) and shall disseminate
p.000873: the findings with respect to each such evaluation to appropriate public and pri- vate entities.
p.000873: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000873: to be appropriated
p.000873: $5,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003.
p.000873: Subpart 3—Center for Mental Health Services
p.000873: CENTER FOR MENTAL HEALTH SERVICES
p.000873: SEC. 520. ø290bb–31¿ (a) ESTABLISHMENT.—There is estab- lished in the Administration a Center for Mental
p.000873: Health Services (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000873: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000873: individ- uals with extensive experience or academic qualifications in the provision of mental health
p.000873: services or in the evaluation of mental health service systems.
p.000873: (b) DUTIES.—The Director of the Center shall—
p.000873: (1) design national goals and establish national priorities for—
p.000873: (A) the prevention of mental illness; and
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p.001027: appoint the members of the Advisory Committee from among individuals who are health professionals. In
p.001027: making such appointments, the Secretary shall ensure a fair balance between the health professions, that at
p.001027: least 75 percent of the members of the Ad- visory Committee are health professionals, a broad geographic representation
p.001027: of members and a balance between urban and rural members. Members shall be appointed based on their
p.001027: competence, interest, and knowledge of the mission of the pro- fession involved.
p.001027: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001027: the Sec-
p.001027:
p.001027:
p.001027:
p.001027:
p.001027:
p.001027: January 30, 2020
p.001027: 8 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted
p.001027: July 1, 1944. Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which
p.001027: added section 748. That Act is Public Law 105–392, enacted November 13, 1998. (Section 102(4) of that Public Law (112
p.001027: Stat. 3539) added section 748.)
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001029: PUBLIC HEALTH SERVICE ACT
p.001029: Sec. 749
p.001029:
p.001029: retary shall ensure the adequate representation of women and minorities.
p.001029: (c) TERMS.—
p.001029: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001029: that of the members first appointed—
p.001029: (A) 1⁄3 of such members shall serve for a term of 1 year;
p.001029: (B) 1⁄3 of such members shall serve for a term of 2 years; and
p.001029: (C) 1⁄3 of such members shall serve for a term of 3 years.
p.001029: (2) VACANCIES.—
p.001029: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
p.001029: original appointment was made and shall be subject to any condi- tions which applied with respect to the
p.001029: original appoint- ment.
p.001029: (B) FILLING UNEXPIRED TERM.—An individual chosen to fill a vacancy shall be appointed for the unexpired term
p.001029: of the member replaced.
p.001029: (d) DUTIES.—The Advisory Committee shall—
p.001029: (1) provide advice and recommendations to the Secretary concerning policy and program development and other
p.001029: matters of significance concerning the activities under section 747;
p.001029: (2) not later than 3 years after the date of enactment of this section, and annually thereafter,
p.001029: prepare and submit to the Secretary, and the Committee on Labor and Human Re- sources of the Senate, and
p.001029: the Committee on Commerce of the House of Representatives, a report describing the activities of the Committee,
p.001029: including findings and recommendations made by the Committee concerning the activities under section 747;
p.001029: (3) develop, publish, and implement performance measures for programs under this part;
p.001029: (4) develop and publish guidelines for longitudinal evalua- tions (as described in section 761(d)(2)) for programs
p.001029: under this part; and
...

p.001047: (4) For grants described in subsection (a)(4), $10,000,000.
p.001047: SEC. 757. ø294f¿ ADVISORY COMMITTEE ON INTERDISCIPLINARY, COM- MUNITY-BASED LINKAGES.
p.001047: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001047: Interdiscipli- nary, Community-Based Linkages (in this section referred to as the ‘‘Advisory Committee’’).
p.001047: (b) COMPOSITION.—
p.001047: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001047: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001047: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 12, the Secretary
p.001047: shall appoint the members of the Advisory Committee from among individuals who are health professionals
p.001047: from schools of the types de- scribed in sections 751(b)(1)(A), 753(b), and 755(b). In making such
p.001047: appointments, the Secretary shall ensure a fair balance between the health professions, that at least 75 percent
p.001047: of the members of the Advisory Committee are health professionals, a broad geographic representation of
p.001047: members and a balance between urban and rural members. Members shall be ap- pointed based on their
p.001047: competence, interest, and knowledge of the mission of the profession involved.
p.001047: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001047: the Sec- retary shall ensure the adequate representation of women and minorities.
p.001047: (c) TERMS.—
p.001047:
p.001047:
p.001047:
p.001047:
p.001047:
p.001047: January 30, 2020
p.001047: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001047: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 756.
p.001047: That Act is Public Law 105–392, enacted November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541) added
p.001047: section 756.)
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
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p.001047:
p.001047:
p.001049: 1049
p.001049: PUBLIC HEALTH SERVICE ACT
p.001049: Sec. 757
p.001049:
p.001049: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001049: that of the members first appointed—
p.001049: (A) 1⁄3 of the members shall serve for a term of 1 year;
p.001049: (B) 1⁄3 of the members shall serve for a term of 2 years; and
p.001049: (C) 1⁄3 of the members shall serve for a term of 3 years.
p.001049: (2) VACANCIES.—
p.001049: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
p.001049: original appointment was made and shall be subject to any condi- tions which applied with respect to the
p.001049: original appoint- ment.
p.001049: (B) FILLING UNEXPIRED TERM.—An individual chosen to fill a vacancy shall be appointed for the unexpired term
p.001049: of the member replaced.
...

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p.001051:
p.001051: Sec. 760 PUBLIC HEALTH SERVICE ACT 1052
p.001051:
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p.001051: January 30, 2020
p.001051:
p.001051: in a community-based setting, followed by a vir- tual rotation in which the resident or fellow con-
p.001051: tinues to support the care of patients at the teach- ing health center or in the community-based set- ting
p.001051: through the use of health information tech- nology and, as appropriate, telehealth services;
p.001051: (II) an in-person training track that includes a rotation, during which the resident or fellow practices
p.001051: at a teaching health center or in a com- munity-based setting; or
p.001051: (III) an in-person training track that includes a rotation during which the resident practices in a
p.001051: community-based setting that specializes in the treatment of infants, children, adolescents, or pregnant
p.001051: or postpartum women; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such training.
p.001051: (2) TRAINING FOR OTHER PROVIDERS.—A recipient of a grant under subsection (a)(2)—
p.001051: (A) shall use the grant funds to plan, develop, or oper- ate a training program to provide mental and substance
p.001051: use disorders services in underserved, community-based settings, as appropriate, that integrate primary care
p.001051: and mental and substance use disorders prevention and treat- ment services; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
p.001051: College Accreditation, the Accreditation Commission for Education in Nursing, the Commission on Col- legiate Nursing
...

p.001053: sections (c)(1) and (c)(2); and
p.001053: (ii) community health centers in integrating pri- mary care and mental and substance use disorders
p.001053: treatment; or
p.001053: (D) have the capacity to expand access to mental and substance use disorders services in areas
p.001053: with dem- onstrated need, as determined by the Secretary, such as tribal, rural, or other underserved
p.001053: communities.
p.001053: (2) ACADEMIC UNITS OR PROGRAMS.—In awarding grants under subsection (a)(3), the Secretary shall give priority
p.001053: to eli- gible entities that—
p.001053: (A) have a record of training the greatest percentage of mental and substance use disorders providers who enter
p.001053: and remain in these fields or who enter and remain in set- tings with integrated primary care and mental and
p.001053: sub- stance use disorder prevention and treatment services;
p.001053: (B) have a record of training individuals who are from underrepresented minority groups, including native popu-
p.001053: lations, or from a rural or disadvantaged background;
p.001053: (C) provide training in the care of vulnerable popu- lations such as infants, children, adolescents,
p.001053: pregnant and postpartum women, older adults, homeless individ- uals, victims of abuse or trauma, individuals with
p.001053: disabil- ities, and other groups as defined by the Secretary;
p.001053: (D) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001053: professionals; or
p.001053: (E) provide training in cultural competency and health literacy.
p.001053: (e) DURATION.—Grants awarded under this section shall be for a minimum of 5 years.
p.001053: (f) STUDY AND REPORT.—
p.001053: (1) STUDY.—
p.001053: (A) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources and Services Ad-
p.001053: ministration, shall conduct a study on the results of the demonstration program under this section.
p.001053: (B) DATA SUBMISSION.—Not later than 90 days after the completion of the first year of the training
p.001053: program and each subsequent year that the program is in effect, each recipient of a grant under subsection (a)
p.001053: shall submit to the Secretary such data as the Secretary may require for analysis for the report described in
p.001053: paragraph (2).
p.001053: (2) REPORT TO CONGRESS.—Not later than 1 year after re- ceipt of the data described in paragraph
p.001053: (1)(B), the Secretary shall submit to Congress a report that includes—
p.001053: (A) an analysis of the effect of the demonstration pro- gram under this section on the quality, quantity, and
...

p.001111:
p.001111:
p.001111: January 30, 2020
p.001111: 1 Section 2 of Public Law 106–129 (113 Stat. 1653) designated the Agency as the Agency for Healthcare
p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001111:
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p.001113: 1113
p.001113: PUBLIC HEALTH SERVICE ACT
p.001113: Sec. 902
p.001113:
p.001113: duct and support research and evaluations, and support dem- onstration projects, with respect to—
p.001113: (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and
p.001113: (B) health care for priority populations, which shall in- clude—
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p.001113: January 30, 2020
p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
p.001113: (5) health care technologies, facilities, and equipment;
p.001113: (6) health care costs, productivity, organization, and mar- ket forces;
...

p.001133: (2) PROTECTION TO CONTINUE TO APPLY.—If the privilege and confidentiality protections described in section
p.001133: 922 applied to patient safety work product while an entity was listed, or to
p.001133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001135: 1135
p.001135: PUBLIC HEALTH SERVICE ACT
p.001135: Sec. 926
p.001135:
p.001135: data described in paragraph (1), such protections shall con- tinue to apply to such work product or data after
p.001135: the entity is removed from the listing under subsection (e)(3)(A).
p.001135: (g) DISPOSITION OF WORK PRODUCT AND DATA.—If the Sec- retary removes a patient safety organization
p.001135: from the listing as provided for in subsection (e)(3)(A), with respect to the patient safe- ty work product or
p.001135: data described in subsection (f)(1) that the pa- tient safety organization received from another entity, such
p.001135: former patient safety organization shall—
p.001135: (1) with the approval of the other entity and a patient safety organization, transfer such work product or
p.001135: data to such patient safety organization;
p.001135: (2) return such work product or data to the entity that submitted the work product or data; or
p.001135: (3) if returning such work product or data to such entity is not practicable, destroy such work product or
p.001135: data.
p.001135: SEC. 925. ø299b–24a¿ ACTIVITIES REGARDING WOMEN’S HEALTH.
p.001135: (a) ESTABLISHMENT.—There is established within the Office of the Director, an Office of Women’s Health
p.001135: and Gender-Based Re- search (referred to in this section as the ‘‘Office’’). The Office shall be headed by a
p.001135: director who shall be appointed by the Director of Healthcare and Research Quality.
p.001135: (b) PURPOSE.—The official designated under subsection (a) shall—
p.001135:
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p.001135: January 30, 2020
p.001135: (1) report to the Director on the current Agency level of ac- tivity regarding women’s health, across, where
p.001135: appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the
p.001135: development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes,
p.001135: delivery of health care services, quality of care, and access to health care;
p.001135: (2) establish short-range and long-range goals and objec- tives within the Agency for research important
p.001135: to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within
p.001135: the Agency that relate to health services and medical effectiveness research, for issues of particular concern to
p.001135: women;
p.001135: (3) identify projects in women’s health that should be con- ducted or supported by the Agency;
p.001135: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.001135: profes- sionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and
p.001135: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.001135: Health (established under section 229(b)(4)).
p.001135: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001135: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.001135: SEC. 926. ø299b–25¿ TECHNICAL ASSISTANCE.
p.001135: The Secretary, acting through the Director, may provide tech- nical assistance to patient safety
p.001135: organizations, including con-
p.001135: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001135:
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p.001135: Sec. 927 PUBLIC HEALTH SERVICE ACT 1136
p.001135:
p.001135: vening annual meetings for patient safety organizations to discuss methodology, communication, data collection, or
p.001135: privacy concerns.
p.001135: SEC. 927. ø299b–26¿ SEVERABILITY.
p.001135: If any provision of this part is held to be unconstitutional, the remainder of this part shall not be affected.
p.001135:
p.001135: PART D—HEALTH CARE QUALITY IMPROVEMENT
p.001135: Subpart I—Quality Measure Development
p.001135: SEC. 931. ø299b–31¿ QUALITY MEASURE DEVELOPMENT.
p.001135: (a) QUALITY MEASURE.—In this subpart, the term ‘‘quality measure’’ means a standard for measuring the
p.001135: performance and improvement of population health or of health plans, providers of services, and other
p.001135: clinicians in the delivery of health care services.
p.001135: (b) IDENTIFICATION OF QUALITY MEASURES.—
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p.001237: statement is received by the Secretary and shall not be a qualified health maintenance organization for purposes of
p.001237: section 1310.
p.001237: (h) Whoever knowingly and willfully makes or causes to be made any false statement or representation of
p.001237: a material fact in any statement filed pursuant to this section shall be guilty of a fel- ony and upon conviction
p.001237: thereof shall be fined not more than
p.001237: $25,000 or imprisoned for not more than five years, or both.
p.001237: TITLE XIV—SAFETY OF PUBLIC WATER SYSTEMS
p.001237:
p.001237: øFor Text of This Title See Volume 2 of the Environmental Law Compilation¿
p.001237:
p.001237:
p.001237:
p.001237: January 30, 2020
p.001237: 4 Subsection (e) was repealed by section 810 of Public Law 99–660.
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001237: Sec. 1501 PUBLIC HEALTH SERVICE ACT 1238
p.001237: TITLE XV—PREVENTIVE HEALTH MEAS- URES WITH RESPECT TO BREAST AND CERVICAL CANCERS
p.001237:
p.001237: SEC. 1501. ø300k¿ ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.
p.001237: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.001237: grants to States on the basis of an established competitive review process for the purpose of carrying out programs—
p.001237: (1) to screen women for breast and cervical cancer as a preventive health measure;
p.001237: (2) to provide appropriate referrals for medical treatment of women screened pursuant to paragraph (1)
p.001237: and to ensure, to the extent practicable, the provision of appropriate follow-up services and support services such
p.001237: as case management;
p.001237: (3) to develop and disseminate public information and edu- cation programs for the detection and control of breast and
p.001237: cer- vical cancer;
p.001237: (4) to improve the education, training, and skills of health professionals (including allied health professionals)
p.001237: in the de- tection and control of breast and cervical cancer;
p.001237: (5) to establish mechanisms through which the States can monitor the quality of screening procedures for breast and
p.001237: cer- vical cancer, including the interpretation of such procedures; and
p.001237:
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p.001237: January 30, 2020
p.001237: (6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or
p.001237: program-moni- toring activities.
p.001237: (b) GRANT AND CONTRACT AUTHORITY OF STATES.—
p.001237: (1) IN GENERAL.—A State receiving a grant under sub- section (a) may, subject to paragraphs (2) and
p.001237: (3), expend the grant to carry out the purpose described in such subsection through grants to public and
p.001237: nonprofit private entities and through contracts with public and private entities.
p.001237: (2) CERTAIN APPLICATIONS.—If a nonprofit private entity and a private entity that is not a nonprofit entity
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p.001239: for the facility a certificate (or provisional certificate) issued under section 354 of such Act.’’.
p.001239: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001241: 1241
p.001241: PUBLIC HEALTH SERVICE ACT
p.001241: Sec. 1503
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p.001241: (1) IN GENERAL.—The Secretary shall establish a dem- onstration project under which the Secretary may waive the
p.001241: re- quirements of paragraphs (1) and (4) of subsection (a) for not more than 5 States, if—
p.001241: (A) the State involved will use the waiver to leverage non-Federal funds to supplement each of the
p.001241: services or activities described in paragraphs (1) and (2) of section 1501(a);
p.001241: (B) the application of such requirement would result in a barrier to the enrollment of qualifying women;
p.001241: (C) the State involved—
p.001241: (i) demonstrates, to the satisfaction of the Sec- retary, the manner in which the State will use such
p.001241: waiver to expand the level of screening and follow-up services provided immediately prior to the date on
p.001241: which the waiver is granted; and
p.001241: (ii) provides assurances, satisfactory to the Sec- retary, that the State will, on an annual basis, dem-
p.001241: onstrate, through such documentation as the Secretary may require, that the State has used such waiver as
p.001241: described in clause (i);
p.001241: (D) the State involved submits to the Secretary—
p.001241: (i) assurances, satisfactory to the Secretary, that the State will maintain the average annual level of
p.001241: State fiscal year expenditures for the services and ac- tivities described in paragraphs (1) and (2) of section
p.001241: 1501(a) for the period for which the waiver is granted, and for the period for which any extension of such
p.001241: wavier is granted, at a level that is not less than—
p.001241: (I) the level of the State fiscal year expendi- tures for such services and activities for the fiscal year
p.001241: preceding the first fiscal year for which the waiver is granted; or
p.001241: (II) at the option of the State and upon ap- proval by the Secretary, the average level of the State
p.001241: expenditures for such services and activities for the 3-fiscal year period preceding the first fis- cal year
p.001241: for which the waiver is granted; and
p.001241: (ii) a plan, satisfactory to the Secretary, for main- taining the level of activities carried out under the
p.001241: waiver after the expiration of the waiver and any ex- tension of such waiver;
p.001241: (E) the Secretary finds that granting such a waiver to a State will increase the number of women in the State
p.001241: that receive each of the services or activities described in paragraphs (1) and (2) of section 1501(a),
p.001241: including making available screening procedures for both breast and cervical cancers; and
p.001241: (F) the Secretary finds that granting such a waiver to a State will not adversely affect the quality of each of the
p.001241: services or activities described in paragraphs (1) and (2) of section 1501(a).
p.001241: (2) DURATION OF WAIVER.—
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p.001241: Sec. 1503 PUBLIC HEALTH SERVICE ACT 1242
p.001241:
p.001241: (A) IN GENERAL.—In granting waivers under para- graph (1), the Secretary—
p.001241: (i) shall grant such waivers for a period that is not less than 1 year but not more than 2 years; and
p.001241: (ii) upon request of a State, may extend a waiver for an additional period that is not less than 1
p.001241: year but not more than 2 years in accordance with subpara- graph (B).
p.001241: (B) ADDITIONAL PERIOD.—The Secretary, upon the re- quest of a State that has received a waiver under
p.001241: para- graph (1), shall, at the end of the waiver period described in subparagraph (A)(i), review performance
p.001241: under the waiver and may extend the waiver for an additional period if the Secretary determines that—
p.001241: (i) without an extension of the waiver, there will be a barrier to the enrollment of qualifying women;
p.001241: (ii) the State requesting such extended waiver will use the waiver to leverage non-Federal funds to sup-
p.001241: plement the services or activities described in para- graphs (1) and (2) of section 1501(a);
p.001241: (iii) the waiver has increased, and will continue to increase, the number of women in the State that re- ceive
p.001241: the services or activities described in paragraphs
p.001241: (1) and (2) of section 1501(a);
p.001241: (iv) the waiver has not, and will not, result in lower quality in the State of the services or
p.001241: activities described in paragraphs (1) and (2) of section 1501(a); and
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p.001241: (v) the State has maintained the average annual level of State fiscal expenditures for the services and
p.001241: activities described in paragraphs (1) and (2) of section 1501(a) for the period for which the waiver was grant- ed at
p.001241: a level that is not less than—
p.001241: (I) the level of the State fiscal year expendi- tures for such services and activities for the fiscal year
p.001241: preceding the first fiscal year for which the waiver is granted; or
p.001241: (II) at the option of the State and upon ap- proval by the Secretary, the average level of the State
p.001241: expenditures for such services and activities for the 3-fiscal year period preceding the first fis- cal year
p.001241: for which the waiver is granted.
p.001241: (3) REPORTING REQUIREMENTS.—The Secretary shall in- clude as part of the evaluations and reports required
p.001241: under section 1508, the following:
p.001241: (A) A description of the total amount of dollars lever- aged annually from Non-Federal entities in
p.001241: States receiv- ing a waiver under paragraph (1) and how these amounts were used.
p.001241: (B) With respect to States receiving a waiver under paragraph (1), a description of the percentage of the grant
p.001241: that is expended on providing each of the services or ac- tivities described in—
p.001241: (i) paragraphs (1) and (2) of section 1501(a); and
p.001241: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001243: 1243
p.001243: PUBLIC HEALTH SERVICE ACT
p.001243: Sec. 1504
p.001243:
p.001243: (ii) paragraphs (3) through (6) of section 1501(a).
p.001243: (C) A description of the number of States receiving waivers under paragraph (1) annually.
p.001243: (D) With respect to States receiving a waiver under paragraph (1), a description of—
p.001243: (i) the number of women receiving services under paragraphs (1), (2), and (3) of section 1501(a) in
p.001243: pro- grams before and after the granting of such waiver; and
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p.001243: (ii) the average annual level of State fiscal ex- penditures for the services and activities described
p.001243: in paragraphs (1) and (2) of section 1501(a) for the year preceding the first year for which the waiver
p.001243: was granted.
p.001243: (4) LIMITATION.—Amounts to which a waiver applies under this subsection shall not be used to increase the number of
p.001243: sal- aried employees.
p.001243: (5) DEFINITIONS.—In this subsection:
p.001243: (A) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the meaning given the term in section 4 of the Indian
p.001243: Health Care Improvement Act (25 U.S.C. 1603).
p.001243: (B) TRIBAL ORGANIZATION.—The term ‘‘tribal organiza- tion’’ has the meaning given the term in section 4 of
p.001243: the Indian Health Care Improvement Act.
p.001243: (C) STATE.—The term ‘‘State’’ means each of the sev- eral States of the United States, the District of
p.001243: Columbia, the Commonwealth of Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana
p.001243: Islands, the Re- public of the Marshall Islands, the Federated States of Mi- cronesia, the Republic of Palau, an
p.001243: Indian tribe, and a tribal organization.
p.001243: (6) SUNSET.—The Secretary may not grant a waiver or ex- tension under this subsection after September 30, 2012.
p.001243: SEC. 1504. ø300n¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001243: (a) PRIORITY FOR LOW-INCOME WOMEN.—The Secretary may not make a grant under section 1501 unless the
p.001243: State involved agrees that low-income women will be given priority in the provi- sion of services and
p.001243: activities pursuant to paragraphs (1) and (2) of section 1501(a).
p.001243: (b) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under section
p.001243: 1501 unless the State involved agrees that, if a charge is imposed for the provision of services or activities under
p.001243: the grant, such charge—
p.001243: (1) will be made according to a schedule of charges that is made available to the public;
p.001243: (2) will be adjusted to reflect the income of the woman in- volved; and
p.001243: (3) will not be imposed on any woman with an income of less than 100 percent of the official poverty line,
p.001243: as established by the Director of the Office of Management and Budget and revised by the Secretary in
p.001243: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.001243: (c) STATEWIDE PROVISION OF SERVICES.—
p.001243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001243: Sec. 1504 PUBLIC HEALTH SERVICE ACT 1244
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p.001245: (B) the proportion of such amount of non-Federal con- tributions relative to the amount of Federal funds provided
p.001245: through the grant to the State for the preceding fiscal year.
p.001245: (b) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date of the enactment of the
p.001245: National Breast and Cervical Cancer Early Detection Program Reauthorization of 2007, and annually thereafter,
p.001245: submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on
p.001245: Labor and Human Resources of the Senate, a report summa- rizing evaluations carried out pursuant to subsection
p.001245: (a) during the preceding fiscal year and making such recommendations for admin- istrative and legislative
p.001245: initiatives with respect to this title as the Secretary determines to be appropriate, including recommendations
p.001245: regarding compliance by the States with section 1501(a)(2) and with section 1504(c).
p.001245: SEC. 1509. ø300n–4a¿ SUPPLEMENTAL GRANTS FOR ADDITIONAL PRE- VENTIVE HEALTH SERVICES.
p.001245: (a) DEMONSTRATION PROJECTS.—In the case of States receiving grants under section 1501, the Secretary, acting through
p.001245: the Direc- tor of the Centers for Disease Control and Prevention, may make grants to not more than 3
p.001245: such States to carry out demonstration projects for the purpose of—
p.001245: (1) providing preventive health services in addition to the services authorized in such section, including
p.001245: screenings re- garding blood pressure and cholesterol, and including health education;
p.001245: (2) providing appropriate referrals for medical treatment of women receiving services pursuant to paragraph (1) and
p.001245: ensur-
p.001245: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001247: 1247
p.001247: PUBLIC HEALTH SERVICE ACT
p.001247: Sec. 1601
p.001247:
p.001247: ing, to the extent practicable, the provision of appropriate fol- low-up services; and
p.001247: (3) evaluating activities conducted under paragraphs (1) and (2) through appropriate surveillance or
p.001247: program-moni- toring activities.
p.001247: (b) STATUS AS PARTICIPANT IN PROGRAM REGARDING BREAST AND CERVICAL CANCER.—The Secretary may not
p.001247: make a grant under subsection (a) unless the State involved agrees that services under the grant will be
p.001247: provided only through entities that are screening women for breast or cervical cancer pursuant to a
p.001247: grant under section 1501.
p.001247: (c) APPLICABILITY OF PROVISIONS OF GENERAL PROGRAM.—This title applies to a grant under subsection (a) to the same
p.001247: extent and in the same manner as such title applies to a grant under section 1501.
p.001247: (d) FUNDING.—
p.001247: (1) IN GENERAL.—Subject to paragraph (2), for the purpose of carrying out this section, there are authorized
p.001247: to be appro- priated $3,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years
p.001247: 1995 through 2003.
p.001247: (2) LIMITATION REGARDING FUNDING WITH RESPECT TO BREAST AND CERVICAL CANCER.—The authorization
p.001247: of appro- priations established in paragraph (1) is not effective for a fis- cal year unless the amount appropriated
p.001247: under section 1510(a) for the fiscal year is equal to or greater than $100,000,000.
p.001247: SEC. 1510. ø300n–5¿ FUNDING FOR GENERAL PROGRAM.
p.001247: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this title, there are authorized to
p.001247: be appropriated
p.001247: $50,000,000 for fiscal year 1991, such sums as may be necessary for each of the fiscal years 1992 and
p.001247: 1993, $150,000,000 for fiscal year 1994, such sums as may be necessary for each of the fiscal years
p.001247: 1995 through 2003, $225,000,000 for fiscal year 2008,
p.001247: $245,000,000 for fiscal year 2009, $250,000,000 for fiscal year 2010,
p.001247: $255,000,000 for fiscal year 2011, and $275,000,000 for fiscal year 2012.
p.001247: (b) SET-ASIDE FOR TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND SERVICES.—Of the amounts appropriated under
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p.001309:
p.001309: SEC. 1922. ø300x–22¿ CERTAIN ALLOCATIONS.
p.001309: (a) ALLOCATION REGARDING PRIMARY PREVENTION PRO- GRAMS.—A funding agreement for a grant under
p.001309: section 1921 is that, in expending the grant, the State involved—
p.001309: (1) will expend not less than 20 percent for programs for individuals who do not require treatment for
p.001309: substance abuse, which programs—
p.001309: (A) educate and counsel the individuals on such abuse;
p.001309: and
p.001309: (B) provide for activities to reduce the risk of such
p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
p.001309: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001309: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001309: adequate level of treatments services for women described in such para-
p.001309:
p.001309: 5 Paragraph (2)(A) of section 3303(f) of Public Law 106–310 (114 Stat. 1211) provides as fol- lows:
p.001309: (2) CONFORMING AMENDMENTS.—Effective upon the publication of the regulations devel- oped in accordance with
p.001309: section 1932(e)(1) of the Public Health Service Act (42 U.S.C. 300x– 32(d))—
p.001309: (A) section 1922(c) of the Public Health Service Act (42 U.S.C. 300x–22(c)) is amended by—
p.001309:
p.001309:
p.001309:
p.001309:
p.001309: January 30, 2020
p.001309: (i) striking paragraph (2); and
p.001309: (ii) redesignating paragraph (3) as paragraph (2); and
p.001309: The reference to section 1922(c) probably should be a reference to section 1922(b), as amended by section 3303(a) of
p.001309: such Public Law.
p.001309: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001309: Sec. 1923 PUBLIC HEALTH SERVICE ACT 1310
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p.001309: graph, as indicated by a comparison of the number of such women seeking the services with the availability in
p.001309: the State of the services.
p.001309: (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than
p.001309: 120 days after the date on which the request is made.
p.001309: (C) Any waiver provided by the Secretary under sub- paragraph (A) shall be applicable only to the fiscal year
p.001309: in- volved.
p.001309: (3) CHILDCARE AND PRENATAL CARE.—A funding agreement for a grant under section 1921 for a State is that
p.001309: each entity providing treatment services with amounts reserved under paragraph (1) by the State will,
p.001309: directly or through arrange- ments with other public or nonprofit private entities, make available
p.001309: prenatal care to women receiving such services and, while the women are receiving the services, childcare.
p.001309: SEC. 1923. ø300x–23¿ INTRAVENOUS SUBSTANCE ABUSE.
p.001309: (a) CAPACITY OF TREATMENT PROGRAMS.—
p.001309: (1) NOTIFICATION OF REACHING CAPACITY.—A funding agreement for a grant under section 1921 is that the
p.001309: State in- volved will, in the case of programs of treatment for intra- venous drug abuse, require that
p.001309: any such program receiving amounts from the grant, upon reaching 90 percent of its capac- ity to admit
p.001309: individuals to the program, provide to the State a notification of such fact.
p.001309: (2) PROVISION OF TREATMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001309: will, with respect to notifications under paragraph (1), ensure that each individual who requests and is
p.001309: in need of treatment for intra- venous drug abuse is admitted to a program of such treatment not later than—
p.001309: (A) 14 days after making the request for admission to such a program; or
p.001309: (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on
p.001309: the date of such request and if interim services are made available to the individual not later than 48
p.001309: hours after such request.
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p.001315: (d) TRANSITIONAL GRANTS.—
p.001315: (1) IN GENERAL.—The Secretary shall award grants under this subsection to each State that receives
p.001315: funding under sec- tion 1921 to ensure compliance of each such State with this section.
p.001315: (2) USE OF FUNDS.—A State receiving a grant under this subsection—
p.001315: (A) shall use amounts received under such grant for activities to plan for or ensure compliance in the
p.001315: State with subsection (a); and
p.001315: (B) in the case of a State for which the Secretary has made a determination under subsection (b) that the State
p.001315: is prepared to meet, or has met, the requirements of sub- section (a), may use such funds for tobacco
p.001315: cessation activi- ties, strategies to prevent the use of tobacco products by individuals under the age of
p.001315: 21, or allowable uses under section 1921.
p.001315: (3) SUPPLEMENT NOT SUPPLANT.—Grants under this sub- section shall be used to supplement and not supplant
p.001315: other Federal, State, and local public funds provided for activities under paragraph (2).
p.001315: (4) AUTHORIZATION OF APPROPRIATIONS.—To carry out this subsection, there are authorized to be
p.001315: appropriated
p.001315: $18,580,790 for each of fiscal years 2020 through 2024.
p.001315: (5) SUNSET.—This subsection shall have no force or effect after September 30, 2024.
p.001315: (e) TECHNICAL ASSISTANCE.—The Secretary shall provide tech- nical assistance to States related to the
p.001315: activities required under this section.
p.001315: SEC. 1927. ø300x–27¿ TREATMENT SERVICES FOR PREGNANT WOMEN.
p.001315: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1921 is that the State involved—
p.001315: (1) will ensure that each pregnant woman in the State who seeks or is referred for and would benefit from such
p.001315: services is given preference in admissions to treatment facilities receiv- ing funds pursuant to the grant; and
p.001315: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001317: PUBLIC HEALTH SERVICE ACT
p.001317: Sec. 1928
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p.001317: (2) will, in carrying out paragraph (1), publicize the avail- ability to such women of services from the
p.001317: facilities and the fact that the women receive such preference.
p.001317: (b) REFERRALS REGARDING STATES.—A funding agreement for a grant under section 1921 is that, in
p.001317: carrying out subsection (a)(1)—
p.001317: (1) the State involved will require that, in the event that a treatment facility has insufficient
p.001317: capacity to provide treat- ment services to any woman described in such subsection who seeks the services from
p.001317: the facility, the facility refer the woman to the State; and
p.001317: (2) the State, in the case of each woman for whom a refer- ral under paragraph (1) is made to the State—
p.001317: (A) will refer the woman to a treatment facility that has the capacity to provide treatment
p.001317: services to the woman; or
p.001317: (B) will, if no treatment facility has the capacity to admit the woman, make interim services available
p.001317: to the woman not later than 48 hours after the women 6 seeks the treatment services.
p.001317: SEC. 1928. ø300x–28¿ ADDITIONAL AGREEMENTS.
p.001317: (a) IMPROVEMENT OF PROCESS FOR APPROPRIATE REFERRALS FOR TREATMENT.—With respect to individuals
p.001317: seeking treatment services, a funding agreement for a grant under section 1921 is that the State involved
p.001317: will improve the process in the State for re- ferring the individuals to treatment facilities that can provide
p.001317: to the individuals the treatment modality that is most appropriate for the individuals.
p.001317: (b) PROFESSIONAL DEVELOPMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001317: will ensure that prevention, treatment, and recovery personnel operating in the State’s substance use disorder
p.001317: prevention, treatment, and recovery systems have an opportunity to receive training, on an ongoing basis,
p.001317: concerning—
p.001317: (1) recent trends in substance use disorders in the State;
p.001317: (2) improved methods and evidence-based practices for pro- viding substance use disorder prevention and treatment
p.001317: serv- ices;
p.001317: (3) performance-based accountability;
p.001317: (4) data collection and reporting requirements; and
p.001317: (5) any other matters that would serve to further improve the delivery of substance use disorder prevention and
p.001317: treat- ment services within the State.
p.001317: (c) COORDINATION OF VARIOUS ACTIVITIES AND SERVICES.—A funding agreement for a grant under section 1921 is
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p.001321: the Secretary; and
p.001321: (B) the State provides assurances satisfactory to the Sec- retary that the State complied with the
p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001321: Sec. 1932 PUBLIC HEALTH SERVICE ACT 1322
p.001321:
p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
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p.001371: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1372
p.001371:
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (2) VACCINES RECOMMENDED AFTER AUGUST 1, 1993.—When after August 1, 1993, the Centers for Disease Control and Pre-
p.001371: vention recommends a vaccine to the Secretary for routine ad- ministration to children, the Secretary shall, within 2
p.001371: years of such recommendation, amend the Vaccine Injury Table in- cluded in subsection (a) to include—
p.001371: (A) vaccines which were recommended for routine ad- ministration to children,
p.001371: (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
p.001371: (C) the time period in which the first symptoms or manifestations of onset or other significant
p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (3) VACCINES RECOMMENDED FOR USE IN PREGNANT WOMEN.—The Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines
p.001371: recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and
p.001371: the information described in subpara- graphs (B) and (C) of paragraph (2) with respect to such vac- cines.
p.001371: COMPENSATION
p.001371: SEC. 2115. ø300aa–15¿ (a) GENERAL RULE.—Compensation awarded under the Program to a petitioner under section
p.001371: 2111 for a vaccine-related injury or death associated with the administra- tion of a vaccine after the
p.001371: effective date of this part 8 shall include the following:
p.001371: (1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and
p.001371: reasonable projected unreimbursable expenses which—
p.001371: (i) result from the vaccine-related injury for which the petitioner seeks compensation,
p.001371: (ii) have been or will be incurred by or on behalf of the person who suffered such injury, and
p.001371: (iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be
p.001371: reasonably nec- essary, or
p.001371: (II) have been or will be for rehabilitation, develop- mental evaluation, special education, vocational
p.001371: training and placement, case management services, counseling, emotional or behavioral therapy,
p.001371: residential and custodial care and service expenses, special equipment, related trav- el expenses, and facilities
p.001371: determined to be reasonably nec- essary.
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 8 Effective October 1, 1988.
p.001371:
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001399: entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into
p.001399: contracts with public and private such entities, for the purpose of planning and conducting, in the
p.001399: community in- volved, clinical trials of experimental treatments for infection with the etiologic agent for such
p.001399: syndrome that are approved by the Commissioner of Food and Drugs for investigational use under reg- ulations
p.001399: issued under section 505 of the Federal Food, Drug, and Cosmetic Act.
p.001399: (b) REQUIREMENT OF CERTAIN PROJECTS.—
p.001399: (1) Financial assistance under subsection (a) shall include such assistance to community-based organizations and
p.001399: commu- nity health centers for the purpose of—
p.001399: (A) retaining appropriate medical supervision;
p.001399: (B) assisting with administration, data collection and record management; and
p.001399: (C) conducting training of community physicians, nurse practitioners, physicians’ assistants and other health
p.001399: professionals for the purpose of conducting clinical trials. (2)(A) Financial assistance under subsection
p.001399: (a) shall in- clude such assistance for demonstration projects designed to implement and conduct
p.001399: community-based clinical trials in order to provide access to the entire scope of communities af-
p.001399: fected by infections with the etiologic agent for acquired im- mune deficiency syndrome, including
p.001399: minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and
p.001399: individuals who are asymptomatic with
p.001399: respect to such infection.
p.001399:
p.001399:
p.001399:
p.001399:
p.001399:
p.001399: January 30, 2020
p.001399: 3 So in law. Probably should be ‘‘acting through the Director of the National Institute’’. (Sec- tion
p.001399: 2617(b)(1) of Public Law 100–690 expressed the intent to so amend the provision; however, the amendment cannot be
p.001399: executed because the amendatory instructions are to strike ‘‘through the National Institutes of Allergy’’, and this
p.001399: term does not appear in subsection (a) (above).)
p.001399: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001399:
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p.001399:
p.001401: 1401
p.001401: PUBLIC HEALTH SERVICE ACT
p.001401: Sec. 2314
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p.001401: January 30, 2020
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p.001403: (2) with respect to carrying out the purpose for which such assistance is to be provided, the application
p.001403: provides assur- ances of compliance satisfactory to the Secretary; and
p.001403: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001403: assurances, and information as the Secretary determines to be necessary to carry out this section.
p.001403: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001403: to be appropriated such sums as may be necessary for each fiscal year.
p.001403: SEC. 2316. ø300cc–16¿ RESEARCH CENTERS.
p.001403: (a) IN GENERAL.—
p.001403: (1) The Secretary, acting through the Director of the Na- tional Institute of Allergy and Infectious
p.001403: Diseases, may make grants to, and enter into contracts with, public and nonprofit private entities to
p.001403: assist such entities in planning, estab- lishing, or strengthening, and providing basic operating sup-
p.001403: port for, centers for basic and clinical research into, and train- ing in, advanced diagnostic, prevention, and
p.001403: treatment meth- ods for acquired immune deficiency syndrome.
p.001403: (2) A grant or contract under paragraph (1) shall be pro- vided in accordance with policies established by
p.001403: the Secretary, acting through the Director of the National Institutes of Health, and after consultation
p.001403: with the advisory council for the National Institute of Allergy and Infectious Diseases.
p.001403: (3) The Secretary shall ensure that, as appropriate, clinical research programs carried out under paragraph (1)
p.001403: include as research subjects women, children, hemophiliacs, and minori- ties.
p.001403: (b) USE OF FINANCIAL ASSISTANCE.—
p.001403: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001403:
p.001403:
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p.001403:
p.001403: Sec. 2317 PUBLIC HEALTH SERVICE ACT 1404
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p.001403:
p.001403: January 30, 2020
p.001403:
p.001403: (1) Financial assistance under subsection (a) may be ex- pended for—
p.001403: (A) the renovation or leasing of space;
p.001403: (B) staffing and other basic operating costs, including such patient care costs as are required for
p.001403: clinical re- search;
p.001403: (C) clinical training with respect to acquired immune deficiency syndrome (including such training for
p.001403: allied health professionals); and
p.001403: (D) demonstration purposes, including projects in the long-term monitoring and outpatient treatment of
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p.001405: Sec. 2318 PUBLIC HEALTH SERVICE ACT 1406
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p.001405: January 30, 2020
p.001405:
p.001405: SEC. 2318. ø300cc–18¿ DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE OF INFECTED INDIVIDUALS.
p.001405: (a) IN GENERAL.—
p.001405: (1) The Secretary, acting through the Director of the Na- tional Institutes of Health and after consultation
p.001405: with the Ad- ministrator for Health Care Policy and Research, may make grants to public and nonprofit private
p.001405: entities for the establish- ment of projects to develop model protocols for the clinical care of individuals infected
p.001405: with the etiologic agent for acquired im- mune deficiency syndrome, including treatment and prevention of HIV infection
p.001405: and related conditions among women.
p.001405: (2) The Secretary may not make a grant under paragraph
p.001405: (1) unless—
p.001405: (A) the applicant for the grant is a provider of com- prehensive primary care; or
p.001405: (B) the applicant for the grant agrees, with respect to the project carried out pursuant to paragraph (1), to enter
p.001405: into a cooperative arrangement with an entity that is a provider of comprehensive primary care.
p.001405: (b) REQUIREMENT OF PROVISION OF CERTAIN SERVICES.—The Secretary may not make a grant under subsection
p.001405: (a) unless the applicant for the grant agrees that, with respect to patients partici- pating in the project
p.001405: carried out with the grant, services provided pursuant to the grant will include—
p.001405: (1) monitoring, in clinical laboratories, of the condition of such patients;
p.001405: (2) clinical intervention for infection with the etiologic agent for acquired immune deficiency
p.001405: syndrome, including measures for the prevention of conditions arising from the in- fection;
p.001405: (3) information and counseling on the availability of treat- ments for such infection approved by the Commissioner of
p.001405: Food and Drugs, on the availability of treatments for such infection not yet approved by the Commissioner, and
p.001405: on the reports issued by the AIDS Research Advisory Committee under sec- tion 2304(c)(2)(B);
p.001405: (4) support groups; and
p.001405: (5) information on, and referrals to, entities providing ap- propriate social support services.
p.001405: (c) LIMITATION ON IMPOSITION OF CHARGES FOR SERVICES.— The Secretary may not make a grant under
p.001405: subsection (a) unless the applicant for the grant agrees that, if the applicant will rou- tinely impose a
...

p.001413: avail- able for such year for carrying out AIDS activities that are not referred to in subparagraph (A). Such
p.001413: allocation shall,
p.001413: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001413: Sec. 2354 PUBLIC HEALTH SERVICE ACT 1414
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p.001413: January 30, 2020
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p.001413: to the extent practicable, be made not later than 30 days after the date on which the Director
p.001413: receives amounts under paragraph (2).
p.001413: SEC. 2354. ø300cc–41¿ ADDITIONAL AUTHORITIES.
p.001413: (a) IN GENERAL.—In carrying out AIDS research, the Director of the Office—
p.001413: (1) shall develop and expand clinical trials of treatments and therapies for infection with the etiologic agent
p.001413: for acquired immune deficiency syndrome, including such clinical trials for women, infants, children,
p.001413: hemophiliacs, and minorities;
p.001413: (2) may establish or support the large-scale development and preclinical screening, production, or distribution
p.001413: of special- ized biological materials and other therapeutic substances for AIDS research and set standards of
p.001413: safety and care for persons using such materials;
p.001413: (3) may support—
p.001413: (A) AIDS research conducted outside the United States by qualified foreign professionals if such
p.001413: research can reasonably be expected to benefit the people of the United States;
p.001413: (B) collaborative research involving American and for- eign participants; and
p.001413: (C) the training of American scientists abroad and for- eign scientists in the United States;
p.001413: (4) may encourage and coordinate AIDS research con- ducted by any industrial concern that evidences
p.001413: a particular capability for the conduct of such research;
p.001413: (5)(A) may acquire, improve, repair, operate, and maintain laboratories, other research facilities, equipment,
p.001413: and such other real or personal property as the Director of the Office de- termines necessary;
p.001413: (B) may make grants for the construction or renovation of facilities; and
p.001413: (C) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34) by lease or otherwise through the
p.001413: Adminis- trator of General Services, buildings or parts of buildings in the District of Columbia or
p.001413: communities located adjacent to the District of Columbia for the use of the National Institutes of Health for
p.001413: a period not to exceed ten years; and
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p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
p.001443: (A) IN GENERAL.—In providing for a council for pur- poses of paragraph (1), a chief elected official
p.001443: receiving a grant under section 2601(a) may establish the council di- rectly or designate an existing entity
p.001443: to serve as the coun- cil, subject to subparagraph (B).
p.001443: (B) CONSIDERATION REGARDING DESIGNATION OF COUN- CIL.—In making a determination of whether to establish or
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: PUBLIC HEALTH SERVICE ACT
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p.001453: in the eli- gible area involved becoming eligible for such an in- crease.
p.001453: (C) LIMITATION.—This paragraph may not be con- strued as having any applicability after fiscal year 2013.
p.001453: (b) SUPPLEMENTAL GRANTS.—
p.001453: (1) IN GENERAL.—Subject to subsection (a)(4)(B)(i) and sec- tion 2610(d), the Secretary shall disburse the
p.001453: remainder of amounts not disbursed under section 2603(a)(2) for such fiscal year for the purpose of making grants
p.001453: under section 2601(a) to eligible areas whose application under section 2605(b)—
p.001453: (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) and the
p.001453: plan for utilization of such funds;
p.001453: (B) demonstrates the need in such area, on an objec- tive and quantified basis, for supplemental financial
p.001453: assist- ance to combat the HIV epidemic;
p.001453: (C) demonstrates the existing commitment of local re- sources of the area, both financial and in-kind, to com-
p.001453: bating the HIV epidemic;
p.001453: (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is
p.001453: im- mediately responsive and cost effective;
p.001453: (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of
p.001453: AIDS including appropriate allocations for services for infants, children, youth, women, and families with
p.001453: HIV/AIDS;
p.001453: (F) demonstrates the inclusiveness of affected commu- nities and individuals with HIV/AIDS;
p.001453: (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment
p.001453: and the statewide coordinated statement of need;
p.001453: (H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most
p.001453: recent grant year under subsection (a) for which data is available, more than 5 percent of grant funds under such
p.001453: subsection canceled, offset under subsection (c)(4), or covered by any waivers under subsection (c)(3); and
p.001453: (I) demonstrates success in identifying individuals with HIV/AIDS as described in clauses (i) through
p.001453: (iii) of paragraph (2)(A).
p.001453: (2) AMOUNT OF GRANT.—
p.001453: (A) IN GENERAL.—The amount of each grant made for purposes of this subsection shall be determined by the Sec-
p.001453: retary based on a weighting of factors under paragraph (1), with demonstrated need under subparagraph (B) of
p.001453: such paragraph counting one-third, and demonstrated success in identifying individuals with HIV/AIDS who do not
p.001453: know their HIV status and making them aware of such status counting one-third. In making such
p.001453: determination, the Secretary shall consider—
p.001453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001461: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001461: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, the
p.001461: chief elected official of an eligible area, in accordance with the established priorities of the planning
p.001461: council, shall for each of such populations in the eligible area use, from the grants made for the area under
p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
p.001461: involved (infants, chil- dren, youth, or women in such area) with HIV/AIDS to the general population in
p.001461: such area of individuals with HIV/AIDS.
p.001461: (2) WAIVER.—With respect to the population involved, the Secretary may provide to the chief elected official of
p.001461: an eligible area a waiver of the requirement of paragraph (1) if such offi- cial demonstrates to the satisfaction
p.001461: of the Secretary that the population is receiving HIV-related health services through the State medicaid program
p.001461: under title XIX of the Social Security Act, the State children’s health insurance program under title XXI
p.001461: of such Act, or other Federal or State programs.
p.001461: (g) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.001461: (1) PROVISION OF SERVICE.—Subject to paragraph (2), the Secretary may not make a grant under section 2601(a) for
p.001461: the provision of services under this section in a State unless, in the case of any such service that is available
p.001461: pursuant to the State plan approved under title XIX of the Social Security Act for the State—
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p.001461: January 30, 2020
p.001461: (A) the political subdivision involved will provide the service directly, and the political subdivision
p.001461: has entered into a participation agreement under the State plan and is qualified to receive payments under such plan;
p.001461: or
...

p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
p.001473: State shall for each of such populations in the eligible area use, from the grants made for the area
p.001473: under section 2601(a) for a fiscal year, not less than the percentage constituted by the ratio of the
p.001473: population in- volved (infants, children, youth, or women in such area) with HIV/AIDS to the general
p.001473: population in such area of individuals with HIV/AIDS.
p.001473: (2) WAIVER.—With respect to the population involved, the Secretary may provide to a State a waiver of
p.001473: the requirement of paragraph (1) if such State demonstrates to the satisfaction
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001475: PUBLIC HEALTH SERVICE ACT
p.001475: Sec. 2613
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p.001475:
p.001475: January 30, 2020
p.001475: of the Secretary that the population is receiving HIV-related health services through the State medicaid
p.001475: program under title XIX of the Social Security Act, the State children’s health in- surance program under
...

p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001477: January 30, 2020
p.001477:
p.001477: (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for
p.001477: adult and pediatric HIV-related care demonstration projects; and then
p.001477: (2) to any other existing HIV care consortia.
p.001477: (f) ALLOCATION OF FUNDS; TREATMENT AS SUPPORT SERVICES.— For purposes of the requirement of section 2612(b)(1),
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p.001497:
p.001497:
p.001497:
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p.001497:
p.001497: January 30, 2020
p.001497:
p.001497: (3) agree that the grant will be used to provide funds di- rectly to emerging communities in the
p.001497: State, separately from other funds under this title that are provided by the State to such communities;
p.001497: and
p.001497: (4) submit the information described in subsection (c).
p.001497: (c) REPORTING REQUIREMENTS.—A State that desires a grant under this section shall, as part of the State
p.001497: application submitted under section 2617, submit a detailed description of the manner in which the State will use
p.001497: amounts received under the grant and of the severity of need. Such description shall include—
p.001497: (1) a report concerning the dissemination of supplemental funds under this section and the plan for the
p.001497: utilization of such funds in the emerging community;
p.001497: (2) a demonstration of the existing commitment of local re- sources, both financial and in-kind;
p.001497: (3) a demonstration that the State will maintain HIV-re- lated activities at a level that is equal to not less
p.001497: than the level of such activities in the State for the 1-year period preceding the fiscal year for which
p.001497: the State is applying to receive a grant under section 2611;
p.001497: (4) a demonstration of the ability of the State to utilize such supplemental financial resources in a manner
p.001497: that is im- mediately responsive and cost effective;
p.001497: (5) a demonstration that the resources will be allocated in accordance with the local demographic incidence of
p.001497: AIDS in- cluding appropriate allocations for services for infants, chil- dren, women, and families with
p.001497: HIV/AIDS;
p.001497: (6) a demonstration of the inclusiveness of the planning process, with particular emphasis on affected
p.001497: communities and individuals with HIV/AIDS; and
p.001497: (7) a demonstration of the manner in which the proposed services are consistent with local needs
p.001497: assessments and the statewide coordinated statement of need.
p.001497: (d) DEFINITIONS OF EMERGING COMMUNITY.—For purposes of this section, the term ‘‘emerging community’’ means a
p.001497: metropolitan area (as defined in section 2607) for which there has been reported to and confirmed by the Director of
p.001497: the Centers for Disease Control and Prevention a cumulative total of at least 500, but fewer than 1,000,
p.001497: cases of AIDS during the most recent period of 5 calendar years for which such data are available.
p.001497: (e) CONTINUED STATUS AS EMERGING COMMUNITY.—Notwith- standing any other provision of this section, a
p.001497: metropolitan area that is an emerging community for a fiscal year continues to be an emerging community until the
p.001497: metropolitan area fails, for three consecutive fiscal years—
p.001497: (1) to meet the requirements of subsection (d); and
p.001497: (2) to have a cumulative total of 750 or more living cases of AIDS (reported to and confirmed by the
p.001497: Director of the Cen- ters for Disease Control and Prevention) as of December 31 of the most recent calendar year for
p.001497: which such data is available.
p.001497: (f) DISTRIBUTION.—The amount of a grant under subsection (a) for a State for a fiscal year shall be an amount equal to
p.001497: the product of—
p.001497: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001497:
...

p.001501:
p.001501: Sec. 2625 PUBLIC HEALTH SERVICE ACT 1502
p.001501: Subpart II—Provisions Concerning Pregnancy and Perinatal Transmission of HIV
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p.001501: January 30, 2020
p.001501:
p.001501: SEC. 2625. ø300ff–33¿ EARLY DIAGNOSIS GRANT PROGRAM.
p.001501: (a) IN GENERAL.—In the case of States whose laws or regula- tions are in accordance with subsection
p.001501: (b), the Secretary, acting through the Centers for Disease Control and Prevention, shall make grants to
p.001501: such States for the purposes described in sub- section (c).
p.001501: (b) DESCRIPTION OF COMPLIANT STATES.—For purposes of sub- section (a), the laws or regulations of a
p.001501: State are in accordance with this subsection if, under such laws or regulations (including programs
p.001501: carried out pursuant to the discretion of State officials), both of the policies described in paragraph (1) are
p.001501: in effect, or both of the policies described in paragraph (2) are in effect, as follows:
p.001501: (1)(A) Voluntary opt-out testing of pregnant women.
p.001501: (B) Universal testing of newborns.
p.001501: (2)(A) Voluntary opt-out testing of clients at sexually transmitted disease clinics.
p.001501: (B) Voluntary opt-out testing of clients at substance abuse treatment centers.
p.001501: The Secretary shall periodically ensure that the applicable policies are being carried out and recertify compliance.
p.001501: (c) USE OF FUNDS.—A State may use funds provided under subsection (a) for HIV/AIDS testing (including
p.001501: rapid testing), pre- vention counseling, treatment of newborns exposed to HIV/AIDS, treatment of mothers
p.001501: infected with HIV/AIDS, and costs associated with linking those diagnosed with HIV/AIDS to care and treatment for
p.001501: HIV/AIDS.
p.001501: (d) APPLICATION.—A State that is eligible for the grant under subsection (a) shall submit an application to
p.001501: the Secretary, in such form, in such manner, and containing such information as the Sec- retary may require.
p.001501: (e) LIMITATION ON AMOUNT OF GRANT.—A grant under sub- section (a) to a State for a fiscal year may
p.001501: not be made in an amount exceeding $10,000,000.
p.001501: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to pre-empt State laws regarding
p.001501: HIV/AIDS counseling and testing.
...

p.001503: Nothing in this subpart shall be construed to disqualify a State from receiving grants under this title if such State
p.001503: has established at any time prior to or after the date of enactment of this subpart a program of mandatory HIV testing.
p.001503: SEC. 2628. ø300ff–37a¿ RECOMMENDATIONS FOR REDUCING INCIDENCE OF PERINATAL TRANSMISSION.
p.001503: (a) STUDY BY INSTITUTE OF MEDICINE.—
p.001503: (1) IN GENERAL.—The Secretary shall request the Institute of Medicine to enter into an agreement with the
p.001503: Secretary
p.001503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001503:
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p.001503: Sec. 2631 PUBLIC HEALTH SERVICE ACT 1504
p.001503: under which such Institute conducts a study to provide the fol- lowing:
p.001503: (A) For the most recent fiscal year for which the infor- mation is available, a determination of the number of new-
p.001503: born infants with HIV born in the United States with re- spect to whom the attending obstetrician for the
p.001503: birth did not know the HIV status of the mother.
p.001503: (B) A determination for each State of any barriers, in- cluding legal barriers, that prevent or discourage an obste-
p.001503: trician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn
p.001503: infants for HIV/AIDS in circumstances in which the obste- trician does not know the HIV status of the mother of the
p.001503: infant.
p.001503: (C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, in-
p.001503: cluding recommendations on removing the barriers identi- fied under subparagraph (B).
p.001503: If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another
p.001503: appropriate public or nonprofit private entity to conduct the study.
p.001503: (2) REPORT.—The Secretary shall ensure that, not later than 18 months after the effective date of this
p.001503: section, the study required in paragraph (1) is completed and a report de- scribing the findings made in the
p.001503: study is submitted to the ap- propriate committees of the Congress, the Secretary, and the chief public health
p.001503: official of each of the States.
p.001503: (b) PROGRESS TOWARD RECOMMENDATIONS.—In fiscal year 2004, the Secretary shall collect information
p.001503: from the States de- scribing the actions taken by the States toward meeting the rec- ommendations
p.001503: specified for the States under subsection (a)(1)(C).
p.001503: (c) SUBMISSION OF REPORTS TO CONGRESS.—The Secretary shall submit to the appropriate committees of the
p.001503: Congress reports describing the information collected under subsection (b).
p.001503:
p.001503: Subpart III—Certain Partner Notification Programs
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p.001517:
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
p.001517:
p.001517:
p.001517:
p.001517:
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p.001519: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001519: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001519: be nec- essary to carry out this section. Such application shall include the following:
p.001519: (1) Information regarding how the expected expenditures of the grant are related to the planning process
p.001519: for localities funded under part A (including the planning process outlined in section 2602) and for States
p.001519: funded under part B (including the planning process outlined in section 2617(b)).
p.001519: (2) A specification of the expected expenditures and how those expenditures will improve overall patient
p.001519: outcomes, as outlined as part of the State plan (under section 2617(b)) or through additional outcome
p.001519: measures.
p.001519: (e) ANNUAL REVIEW OF PROGRAMS; EVALUATIONS.—
p.001519: (1) REVIEW REGARDING ACCESS TO AND PARTICIPATION IN PROGRAMS.—With respect to a grant under
p.001519: subsection (a) for an entity for a fiscal year, the Secretary shall, not later than 180 days after the
p.001519: end of the fiscal year, provide for the con- duct and completion of a review of the operation during
p.001519: the year of the program carried out under such subsection by the entity. The purpose of such review shall be
p.001519: the development of recommendations, as appropriate, for improvements in the fol- lowing:
p.001519: (A) Procedures used by the entity to allocate opportu- nities and services under subsection (a) among patients
p.001519: of the entity who are women, infants, children, or youth.
p.001519: (B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
p.001519: (2) EVALUATIONS.—— 14The Secretary shall, directly or through contracts with public and private
p.001519: entities, provide for evaluations of programs carried out pursuant to subsection (a).
p.001519: (f) ADMINISTRATIVE EXPENSES.—
p.001519: (1) LIMITATION.—A grantee may not use more than 10 per- cent of amounts received under a grant awarded under
p.001519: this section for administrative expenses.
p.001519:
p.001519:
p.001519:
p.001519: January 30, 2020
p.001519: 14 Dash so in law.
p.001519:
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001519:
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p.001519:
p.001519: Sec. 2681 PUBLIC HEALTH SERVICE ACT 1520
p.001519:
p.001519: (2) CLINICAL QUALITY MANAGEMENT PROGRAM.—A grantee under this section shall implement a clinical quality
p.001519: manage- ment program to assess the extent to which HIV health serv- ices provided to patients under the
p.001519: grant are consistent with the most recent Public Health Service guidelines for the treat- ment of HIV/AIDS and
p.001519: related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are
...

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p.001523:
p.001525: 1525
p.001525: PUBLIC HEALTH SERVICE ACT
p.001525: Sec. 2689
p.001525:
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p.001525: January 30, 2020
p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
p.001525: (C) NON-AIDS CASES.—The term ‘‘non-AIDS’’, with re- spect to a case of HIV, means that the individual involved
p.001525: has HIV but does not have AIDS.
p.001525: (8) HUMAN IMMUNODEFICIENCY VIRUS.—The term ‘‘human immunodeficiency virus’’ means the etiologic agent for AIDS.
...

p.001527: and integration. To facilitate efforts under this subsection, the Secretary may provide for peer-based
p.001527: technical as- sistance for grantees funded under this part.
p.001527: Subpart II—AIDS Education and Training Centers
p.001527:
p.001527:
p.001527:
p.001527:
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p.001527: January 30, 2020
p.001527: SEC. 2692. ø300ff–111¿ HIV/AIDS COMMUNITIES, SCHOOLS, AND CEN- TERS.
p.001527: (a) SCHOOLS; CENTERS.—
p.001527: (1) IN GENERAL.—The Secretary may make grants and enter into contracts to assist public and nonprofit private
p.001527: enti- ties and schools and academic health science centers in meet- ing the costs of projects—
p.001527: (A) to train health personnel, including practitioners in programs under this title and other community
p.001527: pro- viders, in the diagnosis, treatment, and prevention of HIV/ AIDS, including the prevention of the perinatal
p.001527: trans- mission of the disease, including measures for the preven- tion and treatment of opportunistic infections, and
p.001527: includ- ing (as applicable to the type of health professional in- volved), prenatal and other
p.001527: gynecological care for women with HIV/AIDS;
p.001527: (B) to train the faculty of schools of, and graduate de- partments or programs of, medicine, nursing, osteopathic
p.001527: medicine, dentistry, public health, allied health, and men- tal health practice to teach health professions
p.001527: students to provide for the health care needs of individuals with HIV/ AIDS;
p.001527: (C) to develop and disseminate curricula and resource materials relating to the care and treatment of individuals with
p.001527: such disease and the prevention of the disease among individuals who are at risk of contracting the disease; and
p.001527: (D) to develop protocols for the medical care of women with HIV/AIDS, including prenatal and other gynecological care
p.001527: for such women.
p.001527: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.001527: preference to qualified projects which will—
p.001527: (A) train, or result in the training of, health profes- sionals who will provide treatment for minority
p.001527: individuals and Native Americans with HIV/AIDS and other individ- uals who are at high risk of contracting such
p.001527: disease;
p.001527: (B) train, or result in the training of, minority health professionals and minority allied health
p.001527: professionals to provide treatment for individuals with such disease; and
p.001527: (C) train or result in the training of health profes- sionals and allied health professionals to provide
p.001527: treat- ment for hepatitis B or C co-infected individuals.
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001527:
p.001527:
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p.001527:
p.001527: Sec. 2692 PUBLIC HEALTH SERVICE ACT 1528
p.001527:
p.001527: (3) APPLICATION.—No grant or contract may be made under paragraph (1) unless an application is
p.001527: submitted to the Secretary in such form, at such time, and containing such in- formation, as the Secretary
...

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p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
...

p.001561: A group health plan and a health insurance issuer offering group or individual health insurance coverage
p.001561: shall not rescind such plan or coverage with respect to an enrollee once the enrollee is covered under such plan
p.001561: or coverage involved, except that this section shall not apply to a covered individual who has performed
p.001561: an act or practice that constitutes fraud or makes an intentional misrepresentation of material fact as
p.001561: prohibited by the terms of the plan or coverage. Such plan or coverage may not be cancelled ex- cept with
p.001561: prior notice to the enrollee, and only as permitted under section 2702(c) or 2742(b).
p.001561: SEC. 2713. ø300gg–13¿ COVERAGE OF PREVENTIVE HEALTH SERVICES.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage shall, at a minimum provide coverage for and shall not impose any cost sharing requirements for—
p.001561: (1) evidence-based items or services that have in effect a rating of ‘‘A’’ or ‘‘B’’ in the current
p.001561: recommendations of the United States Preventive Services Task Force;
p.001561: (2) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of
p.001561: the Centers for Disease Control and Prevention with respect to the individual involved; and
p.001561: (3) with respect to infants, children, and adolescents, evi- dence-informed preventive care and screenings
p.001561: provided for in the comprehensive guidelines supported by the Health Re- sources and Services Administration.
p.001561: (4) with respect to women, such additional preventive care and screenings not described in paragraph (1) as
p.001561: provided for in comprehensive guidelines supported by the Health Re- sources and Services Administration
p.001561: for purposes of this para- graph.
p.001561: (5) for the purposes of this Act, and for the purposes of any other provision of law, the current recommendations
p.001561: of the United States Preventive Service Task Force regarding breast cancer screening, mammography, and
p.001561: prevention shall be con- sidered the most current other than those issued in or around November 2009.
p.001561: Nothing in this subsection shall be construed to prohibit a plan or issuer from providing coverage for services in
p.001561: addition to those rec- ommended by United States Preventive Services Task Force or to deny coverage for
p.001561: services that are not recommended by such Task Force.
p.001561: (b) INTERVAL.—
p.001561: (1) IN GENERAL.—The Secretary shall establish a minimum interval between the date on which a recommendation de-
p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001561:
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p.001561: Sec. 2714 PUBLIC HEALTH SERVICE ACT 1562
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p.001623: (E) Effective utilization of any available public and private mobile medical assets (which may include
p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
p.001623: State, local, and tribal operations in the event of a public health emergency.
p.001623: (7) COUNTERMEASURES.—
p.001623: (A) Promoting strategic initiatives to advance counter- measures to diagnose, mitigate, prevent, or treat harm
p.001623: from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally
p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
p.001623: section 319F–3, and ‘‘security countermeasures’’ under section 319F–2.
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001623:
p.001623:
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p.001645: (6) oversee curriculum development for the public health and medical response training program on medical
p.001645: manage- ment of casualties, as it concerns at-risk individuals as de- scribed in subparagraphs (A) through (C)
p.001645: of section 319F(a)(2);
p.001645: (7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk
p.001645: individuals before, during, and following public health emergencies in as timely a manner as is practicable,
p.001645: including from the time a public health threat is identified;
p.001645: (8) ensure that public health and medical information dis- tributed by the Department of Health and Human
p.001645: Services during a public health emergency is delivered in a manner that takes into account the range of communication
p.001645: needs of the in- tended recipients, including at-risk individuals; and
p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
p.001645:
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p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: (A) The service is provided to the individual at a free clin- ic, or through offsite programs or events carried out by
p.000001: the free clinic.
p.000001: (B) The free clinic is sponsoring the health care practi- tioner pursuant to paragraph (5)(C).
p.000001: (C) The service is a qualifying health service (as defined in paragraph (4)).
p.000001: (D) Neither the health care practitioner nor the free clinic receives any compensation for the service from the
p.000001: individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or
p.000001: under any Federal or State health benefits program). With respect to compliance with such condition:
p.000001: (i) The health care practitioner may receive repayment from the free clinic for reasonable expenses incurred by
p.000001: the health care practitioner in the provision of the service to the individual.
p.000001: (ii) The free clinic may accept voluntary donations for the provision of the service by the health care practitioner to
p.000001: the individual.
p.000001: (E) Before the service is provided, the health care practi- tioner or the free clinic provides written
p.000001: notice to the indi- vidual of the extent to which the legal liability of the health care practitioner
p.000001: is limited pursuant to this subsection (or in the case of an emergency, the written notice is provided to the
p.000001: individual as soon after the emergency as is practicable). If the individual is a minor or is otherwise legally
p.000001: incompetent, the condition under this subparagraph is that the written notice be provided to a legal guardian or other
p.000001: person with legal respon- sibility for the care of the individual.
p.000001: (F) At the time the service is provided, the health care practitioner is licensed or certified in accordance
p.000001: with applica- ble law regarding the provision of the service.
p.000001: (3)(A) For purposes of this subsection, the term ‘‘free clinic’’ means a health care facility operated by a
p.000001: nonprofit private entity meeting the following requirements:
p.000001: (i) The entity does not, in providing health services through the facility, accept reimbursement
p.000001: from any third- party payor (including reimbursement under any insurance policy or health plan, or under
p.000001: any Federal or State health benefits program).
p.000001: (ii) The entity, in providing health services through the fa- cility, either does not impose charges on the
p.000001: individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved
p.000001: to pay the charge.
p.000001: (iii) The entity is licensed or certified in accordance with applicable law regarding the provision of health
p.000001: services.
p.000001: (B) With respect to compliance with the conditions under sub- paragraph (A), the entity involved may accept voluntary
p.000001: donations for the provision of services.
p.000001: (4) For purposes of this subsection, the term ‘‘qualifying health service’’ means any medical assistance required or
p.000001: authorized to be
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000017: sonnel, other public safety personnel, or support personnel for such occupational specialities;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 261 PUBLIC HEALTH SERVICE ACT 60
p.000017:
p.000017: (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human
p.000017: Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary;
p.000017: (C) who has volunteered and been selected to be a member of a smallpox emergency response plan
p.000017: described in subparagraph (B) prior to the time at which the Sec- retary publicly announces that an
p.000017: active case of smallpox has been identified either within or outside of the United States; and
p.000017: (D) to whom a smallpox vaccine is administered pur- suant to such approved plan during the effective period of
p.000017: the Declaration (including the portion of such period before the enactment of this part).
p.000017: (3) COVERED INJURY.—The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other
p.000017: than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures
p.000017: established under sec- tion 262, to have been sustained by an individual as the direct result of—
p.000017: (A) administration to the individual of a covered coun- termeasure during the effective period of the
p.000017: Declaration; or
p.000017:
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p.000017: January 30, 2020
p.000017: (B) accidental vaccinia inoculation of the individual in circumstances in which—
p.000017: (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after
p.000017: the end of such period;
p.000017: (ii) smallpox vaccine has not been administered to the individual; and
p.000017: (iii) the individual has been in contact with an in- dividual who is (or who was accidentally inoculated by) a
p.000017: covered individual.
p.000017: (4) DECLARATION.—The term ‘‘Declaration’’ means the Dec- laration Regarding Administration of Smallpox
p.000017: Counter- measures issued by the Secretary on January 24, 2003, and published in the Federal Register on
p.000017: January 28, 2003.
p.000017: (5) EFFECTIVE PERIOD OF THE DECLARATION.—The term ‘‘ef- fective period of the Declaration’’ means the
p.000017: effective period specified in the Declaration, unless extended by the Secretary.
p.000017: (6) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who is (as determined in accordance
p.000017: with section 262)—
p.000017: (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or
...

p.000017: (a) IN GENERAL.—Subject to the succeeding provisions of this section, the Secretary shall provide compensation
p.000017: to an eligible in- dividual for loss of employment income (based on such income at the time of injury)
p.000017: incurred as a result of a covered injury, at the rate specified in subsection (b).
p.000017: (b) AMOUNT OF COMPENSATION.—
p.000017: (1) IN GENERAL.—Compensation under subsection (a) shall be at the rate of 662⁄3 percent of the relevant pay period
p.000017: (week- ly, monthly, or otherwise), except as provided in paragraph (2).
p.000017: (2) AUGMENTED COMPENSATION FOR DEPENDENTS.—If an el- igible individual has one or more dependents, the basic
p.000017: com- pensation for loss of employment income as described in para- graph (1) shall be augmented at the rate of 81⁄3
p.000017: percent.
p.000017: (3) CONSIDERATION OF OTHER PROGRAMS.—
p.000017: (A) IN GENERAL.—The Secretary may consider the pro- visions of sections 8114, 8115, and 8146a of title 5, United States
p.000017: Code, and any implementing regulations, in deter- mining the amount of payment under subsection (a) and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 265 PUBLIC HEALTH SERVICE ACT 64
p.000017:
p.000017: the circumstances under which such payments are reason- able and necessary.
p.000017: (B) MINORS.—With respect to an eligible individual who is a minor, the Secretary may consider the provisions of
p.000017: section 8113 of title 5, United States Code, and any im- plementing regulations, in determining the amount of pay- ment
p.000017: under subsection (a) and the circumstances under which such payments are reasonable and necessary.
p.000017: (4) TREATMENT OF SELF-EMPLOYMENT INCOME.—For pur- poses of this section, the term ‘‘employment income’’
p.000017: includes income from self-employment.
p.000017: (c) LIMITATIONS.—
p.000017: (1) BENEFITS SECONDARY TO OTHER COVERAGE.—
p.000017: (A) IN GENERAL.—Any compensation under subsection
p.000017: (a) shall be secondary to the obligation of the United States or any third party (including any State or local
p.000017: gov- ernmental entity, private insurance carrier, or employer), under any other law or contractual agreement, to
p.000017: pay com- pensation for loss of employment income or to provide dis- ability or retirement benefits.
p.000017: (B) RELATION TO OTHER OBLIGATIONS.—Compensation under subsection (a) shall not be made to an eligible indi- vidual
p.000017: to the extent that the total of amounts paid to the individual under such subsection and under the other
p.000017: obli- gations referred to in subparagraph (A) is an amount that exceeds the rate specified in subsection (b)(1). If
p.000017: under any such other obligation a lump-sum payment is made, such payment shall, for purposes of this
p.000017: paragraph, be deemed to be received over multiple years rather than received in a single year. The
p.000017: Secretary may, in the discretion of the Secretary, determine how to apportion such payment over multiple
p.000017: years.
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p.000017:
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p.000017:
p.000017: 65 PUBLIC HEALTH SERVICE ACT Sec. 266
p.000017:
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B), an eligible individual shall not be provided compensa- tion
p.000017: under this section for the first 5 work days of loss of employment income.
p.000017: (B) EXCEPTION.—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi-
p.000017: vidual is 10 or more work days.
p.000017: (5) TERMINATION OF BENEFITS.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employment income once the eligible individual involves reaches the age of 65.
p.000017: (d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) shall be in addition to
p.000017: any amounts received by an eligible individual under section 264.
p.000017: SEC. 266. ø239e¿ PAYMENT FOR DEATH.
p.000017: (a) DEATH BENEFIT.—
p.000017: (1) IN GENERAL.—The Secretary shall pay, in the case of an eligible individual whose death is determined to have
p.000017: resulted from a covered injury or injuries, a death benefit in the amount determined under
p.000017: paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public
p.000017: Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control
p.000017: and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the
p.000017: case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the
p.000017: survivor in the place of the parent).
p.000017: (2) BENEFIT AMOUNT.—
p.000017: (A) IN GENERAL.—The amount of the death benefit under paragraph (1) in a fiscal year shall equal
p.000017: the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under
p.000017: subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
p.000017: seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but
p.000017: subject to subparagraph (B).
p.000017: (B) REDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT INCOME.—The amount of the benefit as determined under
p.000017: subparagraph (A) shall be reduced by the total amount of any benefits paid under section 265 with
p.000017: respect to lost employment income.
p.000017: (3) LIMITATIONS.—
p.000017: (A) IN GENERAL.—No benefit is payable under para- graph (1) with respect to the death of an eligible individual
p.000017: if—
p.000017:
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p.000017: January 30, 2020
p.000017: (i) a disability benefit is paid with respect to such individual under the Public Safety Officers’ Benefits
p.000017: Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of
p.000017: 1968 (42 U.S.C. 3796 et seq.); or
...

p.000253: 25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489.
p.000253: 26 The placement of this section in title III was carried out to reflect the probable intent of
p.000253: Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to ‘‘Part B of
p.000253: the Public Health Service Act’’, without specifying which title of this Act was the subject of the
p.000253: amendment.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000253:
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p.000253: Sec. 321 PUBLIC HEALTH SERVICE ACT 254
p.000253: laws, or to increase the utilization of dental services by eligible children.
p.000253: (c) DISTRIBUTION.—In awarding grants under this section, the Secretary shall, to the extent practicable,
p.000253: ensure an equitable na- tional geographic distribution of the grants, including areas of the United States
p.000253: where the incidence of early childhood caries is high- est.
p.000253: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000253: $10,000,000 for each the fiscal years 2001 through 2005.
p.000253: PART C—HOSPITALS, MEDICAL EXAMINATIONS, AND MEDICAL CARE
p.000253: HOSPITALS
p.000253: SEC. 321. ø248¿ The Surgeon General, pursuant to regulations, shall—
p.000253: (a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and
p.000253: main- tenance, and provide for the care, treatment, and hospitaliza- tion of patients, including the
p.000253: furnishing of prosthetic and or- thopedic devices; and from time to time with the approval of the
p.000253: President, select suitable sites for and establish such addi- tional institutions, hospitals, and stations in the
p.000253: States and possessions of the United States as in his judgment are nec- essary to enable the Service to
p.000253: discharge its functions and du- ties;
p.000253: (b) Provide for the transfer of Public Health Service pa- tients, in the care of attendants where necessary,
p.000253: between hos- pitals and stations operated by the Service or between such hospitals and stations and other
p.000253: hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such
p.000253: transfer;
p.000253: (c) Provide for the disposal of articles produced by patients in the course of their curative treatment, either by
p.000253: allowing the patient to retain such articles or by selling them and depos- iting the money received therefor
p.000253: to the credit of the appropria- tion from which the materials for making the articles were purchased;
p.000253: (d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of
p.000253: deceased patients; and
p.000253: (e) Provide, to the extent the Surgeon General determines that other public or private funds are not available
p.000253: therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable
p.000253: burial expenses for, any patient dying in a hospital or station.
p.000253:
p.000253:
p.000253:
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p.000389: (h) 59 A partially processed biological product which—
p.000389: (1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
p.000389: (2) is not intended for sale in the United States; and
p.000389: (3) is intended for further manufacture into final dosage form outside the United States,
p.000389: shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and
p.000389: Cosmetic Act (21 U.S.C. 321 et. seq.) if the product is manufactured, processed, packaged, and held in
p.000389: conformity with current good manufacturing practice requirements or meets international manufacturing
p.000389: standards as certified by an international standards organization recognized by the Secretary and meets the
p.000389: requirements of section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)).
p.000389: (i) In this section:
p.000389: (1) The term ‘‘biological product’’ means a virus, thera- peutic serum, toxin, antitoxin, vaccine, blood, blood
p.000389: component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of
p.000389: arsphenamine (or any other trivalent organic arsenic compound), applicable to the preven- tion, treatment,
p.000389: or cure of a disease or condition of human beings.
p.000389: (2) The term ‘‘biosimilar’’ or ‘‘biosimilarity’’, in reference to a biological product that is the subject of an
p.000389: application under subsection (k), means—
p.000389: (A) that the biological product is highly similar to the reference product notwithstanding minor differences
p.000389: in clinically inactive components; and
p.000389: (B) there are no clinically meaningful differences be- tween the biological product and the reference
p.000389: product in terms of the safety, purity, and potency of the product.
p.000389: (3) The term ‘‘interchangeable’’ or ‘‘interchangeability’’, in reference to a biological product that is
p.000389: shown to meet the standards described in subsection (k)(4), means that the bio- logical product may be
p.000389: substituted for the reference product without the intervention of the health care provider who pre-
p.000389: scribed the reference product.
p.000389: (4) The term ‘‘reference product’’ means the single biologi- cal product licensed under subsection (a) against
p.000389: which a bio- logical product is evaluated in an application submitted under subsection (k).
p.000389: (j) The Federal Food, Drug, and Cosmetic Act, including the re- quirements under sections 505(o), 505(p), and
p.000389: 505–1 of such Act, applies to a biological product subject to regulation under this sec- tion, except that a
p.000389: product for which a license has been approved
p.000389:
p.000389:
p.000389:
p.000389:
p.000389:
p.000389: January 30, 2020
p.000389: 58 Codification remains chapter 9 of title 21, United States Code (§ 301 et seq.).
p.000389: 59 Section 2102(d)(2) of title II of Public Law 104–134 (110 Stat. 1321-319) amended certain provisions in
p.000389: subsection (h). Subsequently, section 2104 of such Public Law (110 Stat. 1321-320) amended subsection (h) in its
p.000389: entirety. The above reflects only the latter amendment.
p.000389: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000389:
p.000389:
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p.000389: Sec. 351 PUBLIC HEALTH SERVICE ACT 390
p.000389:
p.000389: under subsection (a) shall not be required to have an approved ap- plication under section 505 of such Act.
p.000389: (k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR OR
p.000389: INTERCHANGEABLE.—
p.000389: (1) IN GENERAL.—Any person may submit an application for licensure of a biological product under this
p.000389: subsection.
p.000389: (2) CONTENT.—
p.000389: (A) IN GENERAL.—
p.000389: (i) REQUIRED INFORMATION.—An application sub- mitted under this subsection shall include information demonstrating
p.000389: that—
p.000389: (I) the biological product is biosimilar to a ref- erence product based upon data derived from—
p.000389: (aa) analytical studies that demonstrate that the biological product is highly similar to the reference product
p.000389: notwithstanding minor differences in clinically inactive components;
p.000389: (bb) animal studies (including the assess- ment of toxicity); and
p.000389: (cc) a clinical study or studies (including the assessment of immunogenicity and phar- macokinetics or
p.000389: pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate
p.000389: conditions of use for which the reference product is licensed and intended to be used and for which licen- sure
p.000389: is sought for the biological product;
p.000389: (II) the biological product and reference prod- uct utilize the same mechanism or mechanisms of action for the
p.000389: condition or conditions of use pre- scribed, recommended, or suggested in the pro- posed labeling, but
p.000389: only to the extent the mecha- nism or mechanisms of action are known for the reference product;
p.000389: (III) the condition or conditions of use pre- scribed, recommended, or suggested in the label- ing
p.000389: proposed for the biological product have been previously approved for the reference product;
p.000389: (IV) the route of administration, the dosage form, and the strength of the biological product are the
p.000389: same as those of the reference product; and
p.000389:
p.000389:
p.000389:
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p.000389: January 30, 2020
p.000389: (V) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed
p.000389: to assure that the biological product continues to be safe, pure, and potent.
p.000389: (ii) DETERMINATION BY SECRETARY.—The Sec- retary may determine, in the Secretary’s discretion, that
...

p.000489: such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an
p.000489: applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non- Federal
p.000489: funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
p.000489: (e) RULE OF CONSTRUCTION REGARDING AT-RISK BIRTHS.—For purposes of subsection (a)(1), a pregnant woman
p.000489: shall be consid- ered to be at risk of delivering an infant with a health or develop- mental complication if during
p.000489: the pregnancy the woman—
p.000489: (1) lacks appropriate access to, or information concerning, early and routine prenatal care;
p.000489: (2) lacks the transportation necessary to gain access to the services described in subsection (b);
p.000489: (3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize
p.000489: health and re- lated social services;
p.000489: (4) is fearful of accessing substance abuse services or child and family support services; or
p.000489: (5) is a minor with a low income.
p.000489: (f) DELIVERY OF SERVICES AND CASE MANAGEMENT.—
p.000489: (1) CASE MANAGEMENT MODEL.—Home visiting services provided under this section shall be delivered
p.000489: according to a case management model, and a registered nurse, licensed so- cial worker, or other licensed
p.000489: health care professional with ex- perience and expertise in providing health and related social services in
p.000489: home and community settings shall be assigned as the case manager for individual cases under such model.
p.000489: (2) CASE MANAGER.—A case manager assigned under para- graph (1) shall have primary responsibility for
p.000489: coordinating and overseeing the development of a plan for each family that is to receive home visiting services
p.000489: under this section, and for coordinating the delivery of such services provided through ap- propriate personnel.
p.000489: (3) APPROPRIATE PERSONNEL.—In determining which per- sonnel shall be utilized in the delivery of services,
p.000489: the case manager shall consider—
p.000489: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000489:
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p.000489: Sec. 399 PUBLIC HEALTH SERVICE ACT 490
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p.000489:
p.000491: 491
p.000491: PUBLIC HEALTH SERVICE ACT
p.000491: Sec. 399
p.000491:
p.000491: (1) a description of the population to be targeted for home visiting services and methods of outreach and
p.000491: casefinding for identifying eligible families, including the use of lay home visi- tors where appropriate;
p.000491: (2) a description of the types and qualifications of home visitors used by the entity and the process by which
p.000491: the entity will provide continuing training and sufficient support to the home visitors; and
p.000491: (3) such other information as the Secretary determines to be appropriate.
p.000491: (k) LIMITATION REGARDING ADMINISTRATIVE EXPENSES.—Not more than 10 percent of a grant under subsection
p.000491: (a) may be ex- pended for administrative expenses with respect to the grant. The costs of training
p.000491: individuals to serve in the project involved are not subject to the preceding sentence.
p.000491: (l) RESTRICTIONS ON USE OF GRANT.—To be eligible to receive a grant under this section, an entity must
p.000491: agree that the grant will not be expended—
p.000491: (1) to provide inpatient hospital services;
p.000491: (2) to make cash payments to intended recipients of serv- ices;
p.000491: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000491: build- ing or other facility, or purchase major medical equipment;
p.000491: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000491: of Federal funds; or
p.000491:
p.000491:
p.000491:
p.000491:
p.000491:
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p.000491: January 30, 2020
p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
...

p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
p.000495: the State Interagency Coordinating Council, under part C of the Individuals with Disabilities Education Act.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000495:
p.000495:
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p.000497: 497
p.000497: PUBLIC HEALTH SERVICE ACT
p.000497: Sec. 399A
p.000497:
p.000497: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000497: applicant involved agrees that the grant will not be expended—
p.000497: (1) to provide inpatient hospital services;
p.000497: (2) to make cash payments to intended recipients of serv- ices;
p.000497: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000497: build- ing or other facility, or purchase major medical equipment;
p.000497: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000497: of Federal funds; or
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p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
...

p.000503: populations, and that have—
p.000503: (A) expertise in applying the services to the particular problems of substance abusers and the children
p.000503: of sub- stance abusers; or
p.000503: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs or
p.000503: pediatric health or mental health providers and family mental health providers.
p.000503: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000503: (4) Indian tribes.
p.000503: (f) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent. The
p.000503: Secretary shall ac- cept the value of in-kind contributions, including facilities and per- sonnel, made by the grant
p.000503: recipient as a part or all of the non-Fed- eral share of grants.
p.000503: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000503: applicant involved agrees that the grant will not be expended—
p.000503: (1) to provide inpatient hospital services;
p.000503: (2) to make cash payments to intended recipients of serv-
p.000503: ices;
p.000503: (3) to purchase or improve land, purchase, construct, or
p.000503: permanently improve (other than minor remodeling) any build- ing or other facility, or purchase major medical
p.000503: equipment;
p.000503: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000503: of Federal funds; or
p.000503:
p.000503:
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p.000503:
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p.000503: January 30, 2020
p.000503: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000503: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000503:
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p.000503:
p.000505: 505
p.000505: PUBLIC HEALTH SERVICE ACT
p.000505: Sec. 399A
p.000505:
p.000505: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for health,
p.000505: including maternal and child health 95 mental health, child welfare, edu- cation, juvenile justice, developmental
...

p.000571:
p.000571:
p.000571:
p.000571: January 30, 2020
p.000571:
p.000571: SEC. 399Z. ø280h–3¿ HEALTH PROFESSIONAL EDUCATION AND TRAIN- ING.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in
p.000571: collaboration with the Administrator of the Health Resources and Services Ad- ministration and the heads
p.000571: of other agencies, and in consultation with appropriate health professional associations, shall develop and carry
p.000571: out a program to educate and train health professionals in effective strategies to—
p.000571: (1) better identify and assess patients with obesity or an eating disorder or patients at-risk of
p.000571: becoming obese or devel- oping an eating disorder;
p.000571: (2) counsel, refer, or treat patients with obesity or an eat- ing disorder; and
p.000571: (3) educate patients and their families about effective strategies to improve dietary habits and
p.000571: establish appropriate levels of physical activity.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
p.000571: (a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
p.000571: (1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘‘comprehensive primary health services’’ means the core
p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
p.000571: (B) MENTAL HEALTH.—Mental health and substance use disorder assessments, crisis intervention, counseling,
p.000571: treatment, and referral to a continuum of services includ- ing emergency psychiatric care, community
p.000571: support pro- grams, inpatient care, and outpatient programs.
p.000571: (2) MEDICALLY UNDERSERVED CHILDREN AND ADOLES- CENTS.—
p.000571: (A) IN GENERAL.—The term ‘‘medically underserved children and adolescents’’ means a population of children
p.000571: and adolescents who are residents of an area designated as a medically underserved area or a health
p.000571: professional shortage area by the Secretary.
p.000571: (B) CRITERIA.—The Secretary shall prescribe criteria for determining the specific shortages of personal
p.000571: health services for medically underserved children and adoles- cents under subparagraph (A) that shall—
p.000571: (i) take into account any comments received by the Secretary from the chief executive officer of a State
p.000571: and local officials in a State; and
p.000571: (ii) include factors indicative of the health status of such children and adolescents of an area, including the
...

p.000575: (1) IN GENERAL.—Each eligible entity that receives a grant under this section shall provide, from non-Federal
p.000575: sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in-kind) to carry
p.000575: out the activities supported by the grant.
p.000575: (2) WAIVER.—The Secretary may waive all or part of the matching requirement described in paragraph (1) for any
p.000575: fiscal year for the SBHC if the Secretary determines that applying the matching requirement to the SBHC would
p.000575: result in serious hardship or an inability to carry out the purposes of this sec- tion.
p.000575: (h) SUPPLEMENT, NOT SUPPLANT.—Grant funds provided under this section shall be used to supplement, not
p.000575: supplant, other Fed- eral or State funds.
p.000575: (i) EVALUATION.—The Secretary shall develop and implement a plan for evaluating SBHCs and monitoring quality
p.000575: performance under the awards made under this section.
p.000575: (j) AGE APPROPRIATE SERVICES.—An eligible entity receiving funds under this section shall only provide age
p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000633: informa- tion:
p.000633: (1) An assessment of the state of biomedical and behav- ioral research.
p.000633: (2) A description of the activities conducted or supported by the agencies of the National Institutes of
p.000633: Health and poli- cies respecting the programs of such agencies.
p.000633: (3) A description of intra-National Institutes of Health ac- tivities, including—
p.000633: (A) identification of the percentage of funds made available by each national research institute
p.000633: and national center with respect to each applicable fiscal year for con- ducting or supporting research
p.000633: that involves collaboration between the institute or center and 1 or more other na- tional research
p.000633: institutes or national centers; and
p.000633: (B) recommendations for promoting coordination of in- formation among the centers of excellence.
p.000633: (4) A catalog of all the research activities of the agencies, prepared in accordance with the following:
p.000633: (A) The catalog shall, for each such activity—
p.000633: (i) identify the agency or agencies involved;
p.000633: (ii) state whether the activity was carried out di- rectly by the agencies or was supported by the
p.000633: agen- cies and describe to what extent the agency was in- volved; and
p.000633: (iii) identify whether the activity was carried out through a center of excellence.
p.000633: (B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by
p.000633: demographic variables, including biological and social variables and rel- evant age categories (such as pediatric
p.000633: subgroups), and de- terminants of health, that contribute to research on minor- ity health and health disparities.
p.000633: (C) Research activities listed in the catalog shall in- clude, where applicable, the following:
p.000633: (i) Epidemiological studies and longitudinal stud-
p.000633:
p.000633:
p.000633: January 30, 2020
p.000633: ies.
p.000633:
p.000633: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000633:
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p.000633:
p.000635: 635
p.000635: PUBLIC HEALTH SERVICE ACT
p.000635: Sec. 403
p.000635:
p.000635:
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p.000635: January 30, 2020
p.000635: (ii) Disease registries, information clearinghouses, and other data systems.
p.000635: (iii) Public education and information campaigns.
p.000635: (iv) Training activities, including—
p.000635: (I) National Research Service Awards and Clinical Transformation Science Awards;
...

p.000805: (B) The number of members of minority groups in- cluded as subjects, and the proportion of subjects that are
p.000805: members of minority groups, in any project of clinical re- search conducted during the applicable
p.000805: reporting period, disaggregated by categories of research area, condition, or disease and accounting for
p.000805: single-race and single-ethnicity studies.
p.000805: (C) For the applicable reporting period, the number of projects of clinical research that include women and mem- bers
p.000805: of minority groups and that—
p.000805: (i) have been completed during such reporting pe- riod; and
p.000805: (ii) are being carried out during such reporting pe- riod and have not been completed.
p.000805: (D) The number of studies completed during the appli- cable reporting period for which reporting has been sub-
p.000805: mitted in accordance with subsection (c)(2)(A).
p.000805: (g) DEFINITIONS.—For purposes of this section:
p.000805: (1) The term ‘‘project of clinical research’’ includes a clin- ical trial.
p.000805: (2) The term ‘‘minority group’’ includes subpopulations of minority groups. The Director of NIH shall, through
p.000805: the guide- lines established under subsection (d), define the terms ‘‘minor- ity group’’ and ‘‘subpopulation’’ for
p.000805: purposes of the preceding sentence.
p.000805:
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p.000805: January 30, 2020
p.000805: OFFICE OF RESEARCH INTEGRITY
p.000805: SEC. 493. ø289b¿ (a) IN GENERAL.—
p.000805: (1) ESTABLISHMENT OF OFFICE.—Not later than 90 days after the date of enactment of this section, the Secretary
p.000805: shall establish an office to be known as the Office of Research Integ- rity (referred to in this section as the
p.000805: ‘‘Office’’), which shall be established as an independent entity in the Department of Health and Human
p.000805: Services.
p.000805: (2) APPOINTMENT OF DIRECTOR.—The Office shall be head- ed by a Director, who shall be appointed by the
p.000805: Secretary, be experienced and specially trained in the conduct of research, and have experience in the
p.000805: conduct of investigations of re- search misconduct. The Secretary shall carry out this section acting
p.000805: through the Director of the Office. The Director shall re- port to the Secretary.
p.000805: (3) DEFINITIONS.—
p.000805: (A) The Secretary shall by regulation establish a defi- nition for the term ‘‘research misconduct’’ for purposes
p.000805: of this section.
p.000805: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000805:
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p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000847:
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p.000847:
p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
p.000849: pregnant and postpartum women treatment for substance use dis- orders through programs in which, during
p.000849: the course of receiving treatment—
p.000849: (1) the women reside in or receive outpatient treatment services from facilities provided by the programs;
p.000849: (2) the minor children of the women reside with the women in such facilities, if the women so
p.000849: request; and
p.000849: (3) the services described in subsection (d) are available to or on behalf of the women.
p.000849: (b) AVAILABILITY OF SERVICES FOR EACH PARTICIPANT.—A funding agreement for an award under subsection
p.000849: (a) for an appli- cant is that, in the program operated pursuant to such sub- section—
p.000849: (1) treatment services and each supplemental service will be available through the applicant, either
p.000849: directly or through agreements with other public or nonprofit private entities; and
p.000849: (2) the services will be made available to each woman ad- mitted to the program and her children.
p.000849: (c) INDIVIDUALIZED PLAN OF SERVICES.—A funding agreement for an award under subsection (a) for an applicant is
p.000849: that—
p.000849: (1) in providing authorized services for an eligible woman pursuant to such subsection, the applicant will, in
p.000849: consultation with the women, prepare an individualized plan for the provi- sion of services for the woman and
p.000849: her children; and
p.000849: (2) treatment services under the plan will include—
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p.000901: 901
p.000901: PUBLIC HEALTH SERVICE ACT
p.000901: Sec. 522
p.000901:
p.000901: individuals, including services relating to daily living ac- tivities, personal financial planning,
p.000901: transportation serv- ices, and habilitation and rehabilitation services, prevocational and
p.000901: vocational services, and housing serv- ices;
p.000901: (C) providing assistance to the eligible homeless indi- vidual in obtaining income support services,
p.000901: including housing assistance, supplemental nutrition assistance pro- gram benefits, and supplemental security income
p.000901: benefits;
p.000901: (D) referring the eligible homeless individual for such other services as may be appropriate; and
p.000901: (E) providing representative payee services in accord- ance with section 1631(a)(2) of the Social Security
p.000901: Act if the eligible homeless individual is receiving aid under title XVI of such act and if the applicant is
p.000901: designated by the Secretary to provide such services;
p.000901: (8) supportive and supervisory services in residential set- tings;
p.000901: (9) referrals for primary health services, job training, edu- cational services, and relevant housing services;
p.000901: (10) subject to subsection (h)(1)—
p.000901: (A) minor renovation, expansion, and repair of hous-
p.000901:
p.000901: ing;
p.000901: (B) planning of housing;
p.000901: (C) technical assistance in applying for housing assist-
p.000901:
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p.000901: January 30, 2020
p.000901: ance;
p.000901: (D) improving the coordination of housing services;
p.000901: (E) security deposits;
p.000901: (F) the costs associated with matching eligible home- less individuals with appropriate housing situations; and
p.000901: (G) 1-time rental payments to prevent eviction; and
p.000901: (11) other appropriate services, as determined by the Sec- retary.
p.000901: (c) COORDINATION.—The Secretary may not make payments under section 521 unless the State involved agrees to make
p.000901: grants pursuant to subsection (a) only to entities that have the capacity to provide, directly or through
p.000901: arrangements, the services specified in section 522(b), including coordinating the provision of services in order to
p.000901: meet the needs of eligible homeless individuals who are both mentally ill and suffering from a substance use
p.000901: disorder.
p.000901: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—The Sec- retary may not make payments under section 521 unless the
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p.000905: January 30, 2020
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p.000905: (2) If a State fails to make a repayment required in para- graph (1), the Secretary may offset the amount of
p.000905: the repay- ment against the amount of any payment due to be paid to the State under section 521.
p.000905: (b) WITHHOLDING OF PAYMENTS.—
p.000905: (1) The Secretary may, subject to subsection (c), withhold payments due under section 521 if the
p.000905: Secretary determines that the State involved is not expending amounts received under such section in
p.000905: accordance with the agreements required to be contained in the application submitted by the State pur- suant to section
p.000905: 529.
p.000905: (2) The Secretary shall cease withholding payments from a State under paragraph (1) if the Secretary
p.000905: determines that there are reasonable assurances that the State will expend amounts received under section
p.000905: 521 in accordance with the agreements referred to in such paragraph.
p.000905: (3) The Secretary may not withhold funds under para- graph (1) from a State for a minor failure to
p.000905: comply with the agreements referred to in such paragraph.
p.000905: (c) OPPORTUNITY FOR HEARING.—Before requiring repayment of payments under subsection (a)(1), or withholding
p.000905: payments under subsection (b)(1), the Secretary shall provide to the State an oppor- tunity for a hearing.
p.000905: (d) RULE OF CONSTRUCTION.—Notwithstanding any other pro- vision of this part, a State receiving payments
p.000905: under section 521 may not, with respect to any agreements required to be contained in the application
p.000905: submitted under section 529, be considered to be in violation of any such agreements by reason of the fact
p.000905: that the State, in the regular course of providing services under section 522(b) to eligible homeless
p.000905: individuals, incidentally provides serv- ices to homeless individuals who are not eligible homeless individ- uals.
p.000905: SEC. 532. ø290cc–32¿ PROHIBITION AGAINST CERTAIN FALSE STATE- MENTS.
p.000905: (a) IN GENERAL.—
p.000905: (1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in
p.000905: con- nection with the furnishing of items or services for which amounts may be paid by a State from
p.000905: payments received by the State under section 521.
p.000905: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
...

p.000979: curred by such students;
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section; and
p.000979: (v) in the case of a pharmacy student, has satis- factorily completed three years of training; or
p.000979: (B) an individual who—
p.000979: (i) has previously had a loan insured under this subpart when the individual was a full-time student at an
p.000979: eligible institution;
p.000979: (ii) is in a period during which, pursuant to para- graph (2), the principal amount of such previous loan need
p.000979: not be paid;
p.000979: (iii) has agreed that all funds received under the proposed loan shall be used solely for repayment of in-
p.000979: terest due on previous loans made under this subpart; and
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section;
p.000979: (2) evidenced by a note or other written agreement which—
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p.000979: (A) is made without security and without endorse- ment, except that if the borrower is a minor and such note or
p.000979: other written agreement executed by him would not, under the applicable law, create a binding obligation,
p.000979: an endorsement may be required;
p.000979: (B) provides for repayment of the principal amount of the loan in installments over a period of not
p.000979: less than 10 years (unless sooner repaid) nor more than 25 years begin- ning not earlier than 9 months nor
p.000979: later than 12 months after the date of—
p.000979: (i) the date on which—
p.000979: (I) the borrower ceases to be a participant in an accredited internship or residency program of not more
p.000979: than four years in duration;
p.000979: (II) the borrower completes the fourth year of an accredited internship or residency program of more than four
p.000979: years in duration; or
p.000979: (III) the borrower, if not a participant in a program described in subclause (I) or (II), ceases to
p.000979: carry, at an eligible institution, the normal full-
p.000979: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000979: Sec. 705 PUBLIC HEALTH SERVICE ACT 980
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p.000999: educational activity which is directly related to the health profession for which the borrower is preparing, as
p.000999: determined by the Secretary; or
p.000999: (B) not in excess of two years during which a borrower who is a graduate of such a school is a participant in a fel-
p.000999: lowship training program or a full-time educational activ- ity which—
p.000999: (i) is directly related to the health profession for which such borrower prepared at such school, as deter-
p.000999: mined by the Secretary; and
p.000999: (ii) may be engaged in by the borrower during such a two-year period which begins within twelve months
p.000999: after the completion of the borrower’s partici- pation in advanced professional training described in
p.000999: paragraph (1)(C) or prior to the completion of such borrower’s participation in such training.
p.000999: (d) CANCELLATION OF LIABILITY.—The liability to repay the un- paid balance of such a loan and accrued
p.000999: interest thereon shall be canceled upon the death of the borrower, or if the Secretary deter- mines that he has
p.000999: become permanently, and totally disabled.
p.000999: (e) RATE OF INTEREST.—Such loans shall bear interest, on the unpaid balance of the loan, computed only for
p.000999: periods for which the loan is repayable, at the rate of 5 percent per year.
p.000999: (f) SECURITY OR ENDORSEMENT.—Loans shall be made under this subpart without security or endorsement,
p.000999: except that if the borrower is a minor and the note or other evidence of obligation ex- ecuted by him would not,
p.000999: under the applicable law, create a bind- ing obligation, either security or endorsement may be required.
p.000999: (g) TRANSFERRING AND ASSIGNING LOANS.—No note or other evidence of a loan made under this subpart may be
p.000999: transferred or assigned by the school making the loan except that, if the bor- rowers transfer to another
p.000999: school participating in the program under this subpart, such note or other evidence of a loan may be
p.000999: transferred to such other school.
p.000999: (h) CHARGE WITH RESPECT TO INSURANCE FOR CERTAIN CAN- CELLATIONS.—Subject to regulations of the Secretary, a
p.000999: school may assess a charge with respect to loans made this 4 subpart to cover the costs of insuring
p.000999: against cancellation of liability under sub- section (d).
p.000999: (i) CHARGE WITH RESPECT TO LATE PAYMENTS.—Subject to reg- ulations of the Secretary, and in accordance with
p.000999: this section, a school shall assess a charge with respect to a loan made under this subpart for failure of the
p.000999: borrower to pay all or any part of an in- stallment when it is due and, in the case of a borrower who is enti- tled to
p.000999: deferment of the loan under subsection (c), for any failure to file timely and satisfactory evidence of such
p.000999: entitlement. No such charge may be made if the payment of such installment or the fil-
p.000999:
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p.000999: January 30, 2020
p.000999: 4 So in law. See section 102 of Public Law 102–408 (106 Stat. 1994). Probably should be ‘‘made under this subpart’’.
p.000999: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000999:
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p.001095: and fifth year of such service;
p.001095: (4) the liability to repay the unpaid balance of such loan and accrued interest thereon shall be canceled
p.001095: upon the death of the borrower, or if the Secretary determines that he has be- come permanently and totally disabled;
p.001095: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001095:
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p.001097: 1097
p.001097: PUBLIC HEALTH SERVICE ACT
p.001097: Sec. 836
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p.001097: January 30, 2020
p.001097: (5) such a loan shall bear interest on the unpaid balance of the loan, computed only for periods
p.001097: during which the loan is repayable, at the rate of 5 percent per annum;
p.001097: (6) such a loan shall be made without security or endorse- ment, except that if the borrower is a minor and
p.001097: the note or other evidence of obligation executed by him would not, under the applicable law, create a binding
p.001097: obligation, either security or endorsement may be required;
p.001097: (7) no note or other evidence of any such loan may be transferred or assigned by the school making
p.001097: the loan except that, if the borrower transfers to another school participating in the program under this
p.001097: part, such note or other evidence of a loan may be transferred to such other school; and
p.001097: (8) pursuant to uniform criteria established by the Sec- retary, the repayment period established under
p.001097: paragraph (2) for any student borrower who during the repayment period failed to make consecutive payments and
p.001097: who, during the last 12 months of the repayment period, has made at least 12 con- secutive payments may be extended for
p.001097: a period not to exceed 10 years.
p.001097: (c) Where all or any part of a loan, or interest, is canceled under this section, the Secretary shall pay
p.001097: to the school an amount equal to the school’s proportionate share of the canceled portion, as determined by the
p.001097: Secretary.
p.001097: (d) Any loan for any year by a school from a student loan fund established pursuant to an agreement under this
p.001097: part shall be made in such installments as may be provided in regulations of the Secretary or such agreement and,
p.001097: upon notice to the Secretary by the school that any recipient of a loan is failing to maintain satis- factory
p.001097: standing, any or all further installments of his loans shall be withheld, as may be appropriate.
...

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p.001167: January 30, 2020
p.001167:
p.001167: TOURETTE SYNDROME
p.001167: SEC. 1108. ø300b–7¿ (a) IN GENERAL.—The Secretary shall de- velop and implement outreach programs to educate the
p.001167: public, health care providers, educators and community based organiza- tions about the etiology, symptoms,
p.001167: diagnosis and treatment of Tourette Syndrome, with a particular emphasis on children with Tourette Syndrome.
p.001167: Such programs may be carried out by the Sec- retary directly and through awards of grants or contracts to public or
p.001167: nonprofit private entities.
p.001167: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) shall include—
p.001167: (1) the production and translation of educational materials, including public service announcements;
p.001167: (2) the development of training material for health care providers, educators and community based
p.001167: organizations; and
p.001167: (3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and
p.001167: in minor- ity groups.
p.001167: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001167: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
...

p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001187:
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p.001187: Sec. 1215 PUBLIC HEALTH SERVICE ACT 1188
p.001187:
p.001187: (B) there is no basic life-support system; or
p.001187: (C) there is no advanced life-support system; and
p.001187: (2) the State submits to the Secretary a list of rural areas identified pursuant to paragraph (1) or, if there
p.001187: are no such areas, a statement that there are no such areas.
p.001187: SEC. 1215. ø300d–15¿ RESTRICTIONS ON USE OF PAYMENTS.
p.001187: (a) IN GENERAL.—The Secretary may not, except as provided in subsection (b), make payments under section 1211(a)
p.001187: for a fiscal year unless the State involved agrees that the payments will not be expended—
p.001187: (1) for any purpose other than developing, implementing, and monitoring the modifications required by section
p.001187: 1211(b) to be made to the State plan for the provision of emergency med- ical services;
p.001187: (2) to make cash payments to intended recipients of serv- ices provided pursuant to this section;
p.001187: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property);
p.001187: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001187: of Federal funds; or
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p.001187: January 30, 2020
p.001187: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.001187: (b) WAIVER.—The Secretary may waive a restriction under sub- section (a) only if the Secretary determines that the
p.001187: activities out- lined by the State plan submitted under section 1214(a) by the State involved cannot
p.001187: otherwise be carried out.
p.001187: SEC. 1217. ø300d–17¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001187: The Secretary may not make payments under section 1211(a) to a State for a fiscal year unless—
p.001187: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001187: accordance with this part;
p.001187: (2) the agreements are made through certification from the chief executive officer of the State;
p.001187: (3) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to the
p.001187: Secretary;
p.001187: (4) the application contains the plan provisions and the in- formation required to be submitted to the Secretary
p.001187: pursuant to section 1214; and
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p.001287: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1288
p.001287:
p.001287: cockroaches or other known allergens. For purposes of this sub- paragraph, the term ‘‘integrated pest management’’
p.001287: means an approach to the management of pests in public facilities that combines biological, cultural,
p.001287: physical, and chemical tools in a way that minimizes economic, health, and environmental risks.
p.001287: (F) With respect to activities described in any of subpara- graphs (A) through (E), related planning,
p.001287: administration, and educational activities.
p.001287: (G) Monitoring and evaluation of activities carried out under any of subparagraphs (A) through (F).
p.001287: (2) Except as provided in subsection (b), amounts paid to a State under section 1903 from its allotment
p.001287: under section 1902(b) may only be used for providing services to rape victims and for rape prevention.
p.001287: (3) The Secretary may provide technical assistance to States in planning and operating activities to be carried out
p.001287: under this part.
p.001287: (b) A State may not use amounts paid to it under section 1903
p.001287:
p.001287: to—
p.001287: (1) provide inpatient services,
p.001287: (2) make cash payments to intended recipients of health services,
p.001287: (3) purchase or improve land, purchase, construct, or per- manently improve (other than minor remodeling) any
p.001287: building or other facility, or purchase major medical equipment,
p.001287: (4) satisfy any requirement for the expenditure of non-Fed- eral funds as a condition for the receipt of
p.001287: Federal funds, or
p.001287: (5) provide financial assistance to any entity other than a public or nonprofit private entity.
p.001287: Except as provided in subsection (a)(1)(E), the Secretary may waive the limitation contained in paragraph (3)
p.001287: upon the request of a State if the Secretary finds that there are extraordinary cir- cumstances
p.001287: to justify the waiver and that granting the waiver will assist in carrying out this part.
p.001287: (c) A State may transfer not more than 7 percent of the amount allotted to the State under section
p.001287: 1902(a) for any fiscal year for use by the State under part B of this title and title V of the
p.001287: Social Security Act in such fiscal year as follows: At any time in the first three quarters of the
p.001287: fiscal year a State may transfer not more than 3 percent of the allotment of the State for the fiscal year for
p.001287: such use, and in the last quarter of a fiscal year a State may transfer for such use not more than
p.001287: the remainder of the amount of its allotment which may be transferred.
p.001287: (d) Of the amount paid to any State under section 1903, not more than 10 percent paid from each of
p.001287: its allotments under sub- sections (a) and (b) of section 1902 may be used for administering the funds
p.001287: made available under section 1903. The State will pay from non-Federal sources the remaining costs of
p.001287: administering such funds.
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p.001287: January 30, 2020
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p.001293: funds allotted under this part.
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p.001293: January 30, 2020
p.001293:
p.001293: WITHHOLDING
p.001293: SEC. 1907. ø300w–6¿ (a)(1) The Secretary shall, after adequate notice and an opportunity for a hearing conducted
p.001293: within the af- fected State, withhold funds from any State which does not use its allotment in accordance with
p.001293: the requirements of this part or the certification provided under section 1905. The Secretary shall with- hold
p.001293: such funds until the Secretary finds that the reason for the withholding has been removed and there is
p.001293: reasonable assurance that it will not recur.
p.001293: (2) The Secretary may not institute proceedings to withhold funds under paragraph (1) unless the
p.001293: Secretary has conducted an investigation concerning whether the State has used its allotment in accordance
p.001293: with the requirements of this part or the certification provided under section 1905. Investigations required by
p.001293: this para- graph shall be conducted within the affected State by qualified in- vestigators.
p.001293: (3) The Secretary shall respond in an expeditious manner to complaints of a substantial or serious
p.001293: nature that a State has failed to use funds in accordance with the requirements of this part or certifications
p.001293: provided under section 1905.
p.001293: (4) The Secretary may not withhold funds under paragraph (1) from a State for a minor failure to comply with
p.001293: the requirements of this part or certifications provided under section 1905.
p.001293: (b)(1) The Secretary shall conduct in several States in each fis- cal year investigations of the use of funds
p.001293: received by the States
p.001293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001293:
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p.001293: Sec. 1908 PUBLIC HEALTH SERVICE ACT 1294
p.001293:
p.001293: under this part in order to evaluate compliance with the require- ments of this part and certifications
p.001293: provided under section 1905.
p.001293: (2) The Comptroller General of the United States may conduct investigations of the use of funds received under
p.001293: this part by a State in order to insure compliance with the requirements of this part and certifications
p.001293: provided under section 1905.
p.001293: (c) Each State, and each entity which has received funds from an allotment made to a State under this part,
p.001293: shall make appro- priate books, documents, papers, and records available to the Sec- retary or the
p.001293: Comptroller General of the United States, or any of their duly authorized representatives, for
p.001293: examination, copying, or mechanical reproduction on or off the premises of the appropriate entity upon a
p.001293: reasonable request therefor.
p.001293: (d)(1) In conducting any investigation in a State, the Secretary or the Comptroller General of the United States
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p.001303: to maintain such compliance, the Secretary shall reduce the amount of the allotment under section 1911 for the
p.001303: State for the fiscal year for which the grant is being made by an amount equal to the amount
p.001303: constituting such failure for the previous fiscal year.
p.001303: (ii) ALTERNATIVE.—A State that has failed to com- ply with paragraph (1) and would otherwise be subject to a
p.001303: reduction in the State’s allotment under section 1911 may, upon request by the State, in lieu of having the
p.001303: amount of the allotment under section 1911 for the State reduced for the fiscal year of the grant, agree to comply
p.001303: with a negotiated agreement that is approved by the Secretary and carried out in accordance with
p.001303: guidelines issued by the Secretary. If a State fails to enter into or comply with a negotiated agreement, the
p.001303: Secretary may take action under this paragraph or the terms of the negotiated agreement.
p.001303: (B) SUBMISSION OF INFORMATION TO THE SECRETARY.— The Secretary may make a grant under section 1911 for a fiscal
p.001303: year only if the State involved submits to the Sec- retary information sufficient for the Secretary to make
p.001303: the determination required in subparagraph (A)(i).
p.001303: SEC. 1916. ø300x–5¿ RESTRICTIONS ON USE OF PAYMENTS.
p.001303: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will not
p.001303: expend the grant—
p.001303: (1) to provide inpatient services;
p.001303: (2) to make cash payments to intended recipients of health services;
p.001303: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.001303: build- ing or other facility, or purchase major medical equipment;
p.001303: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001303: of Federal funds; or
p.001303: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.001303: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 1911 is that the
p.001303: State involved will not expend more than 5 percent of the grant for administrative expenses with respect to the grant.
p.001303: SEC. 1917. ø300x–6¿ APPLICATION FOR GRANT.
p.001303: (a) IN GENERAL.—For purposes of section 1911, an application for a grant under such section for a fiscal year
p.001303: in accordance with 4 this section if, subject to subsection (b)—
p.001303: (1) the plan is received by the Secretary not later than September 1 of the fiscal year prior to the fiscal
p.001303: year for which
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p.001303: January 30, 2020
p.001303: 4 So in law. See section 201 of Public Law 102–321 (106 Stat. 384). Probably should be ‘‘is in
p.001303: accordance with’’.
p.001303: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001303:
p.001303: Sec. 1918 PUBLIC HEALTH SERVICE ACT 1304
p.001303:
p.001303: a State is seeking funds, and the report from the previous fis- cal year as required under section 1942(a) is
p.001303: received by De- cember 1 of the fiscal year of the grant;
...

p.001319: such compliance, the Secretary shall reduce the amount of the allotment under section 1921 for the State for
p.001319: the fiscal year for which the grant is being made by an amount equal to the amount constituting such
p.001319: failure for the previous fiscal year.
p.001319: (2) SUBMISSION OF INFORMATION TO SECRETARY.—The Sec- retary may make a grant under section 1921 for a
p.001319: fiscal year only if the State involved submits to the Secretary information sufficient for the Secretary to make the
p.001319: determination required in paragraph (1).
p.001319: (3) ALTERNATIVE.—A State that has failed to comply with this section and would otherwise be subject to
p.001319: a reduction in the State’s allotment under section 1921, may, upon request by the State, in lieu of having the
p.001319: State’s allotment under section 1921 reduced, agree to comply with a negotiated agreement that is approved
p.001319: by the Secretary and carried out in accord- ance with guidelines issued by the Secretary. If a State
p.001319: fails to enter into or comply with a negotiated agreement, the Sec- retary may take action under this
p.001319: paragraph or the terms of the negotiated agreement.
p.001319: SEC. 1931. ø300x–31¿ RESTRICTIONS ON EXPENDITURE OF GRANT.
p.001319: (a) IN GENERAL.—
p.001319: (1) CERTAIN RESTRICTIONS.—A funding agreement for a grant under section 1921 is that the State involved will not
p.001319: ex- pend the grant—
p.001319: (A) to provide inpatient hospital services, except as provided in subsection (b);
p.001319: (B) to make cash payments to intended recipients of health services;
p.001319: (C) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling)
p.001319: any building or other facility, or purchase major medical equipment;
p.001319: (D) to satisfy any requirement for the expenditure of non-Federal funds as a condition for the receipt of
p.001319: Federal funds;
p.001319: (E) to provide financial assistance to any entity other than a public or nonprofit private entity; or
p.001319: (F) to carry out any program prohibited by section 256(b) of the Health Omnibus Programs Extension of 1988 (42
p.001319: U.S.C. 300ee–5).
p.001319: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 1921 is that the State
p.001319: in- volved will not expend more than 5 percent of the grant to pay the costs of administering the grant.
p.001319: (3) LIMITATION REGARDING PENAL AND CORRECTIONAL IN- STITUTIONS.—A funding agreement for a State for a
p.001319: grant under section 1921 is that, in expending the grant for the pur-
p.001319: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001319: Sec. 1931 PUBLIC HEALTH SERVICE ACT 1320
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p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
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p.001343:
p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
...

p.001345: under para- graph (1) that appropriate family planning services are not other- wise available in the
p.001345: community, provides family planning services (other than counseling and referral services) to adolescents may
p.001345: only use funds provided under this title for such family planning services if all funds received by such
p.001345: grantee from all other sources to support such family planning services are insufficient to support such family
p.001345: planning services.
p.001345: (c) Grantees who receive funds for a demonstration project for services under this title shall charge fees for
p.001345: services pursuant to a fee schedule approved by the Secretary as a part of the applica- tion described
p.001345: in section 2006 which bases fees charged by the grantee on the income of the eligible person or the parents or
p.001345: legal guardians of the eligible person and takes into account the dif- ficulty adolescents face in
p.001345: obtaining resources to pay for services. A grantee who receives funds for a demonstration project for serv- ices
p.001345: under this title may not, in any case, discriminate with regard to the provision of services to any individual
p.001345: because of that indi- vidual’s inability to provide payment for such services, except that in determining the
p.001345: ability of an unemancipated minor to provide payment for services, the income of the family of an unemancipated
p.001345: minor shall be considered in determining the ability of such minor to make such payments unless the parents or
p.001345: guardians of the unemancipated minor refuse to make such payments.
p.001345: PRIORITIES, AMOUNTS, AND DURATION OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2005. ø300z–4¿ (a) In approving applications for grants for demonstration projects for services under
p.001345: this title, the Sec- retary shall give priority to applicants who—
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001345:
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p.001345:
p.001345:
p.001347: 1347
p.001347: PUBLIC HEALTH SERVICE ACT
p.001347: Sec. 2005
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p.001347: January 30, 2020
p.001347: (1) serve an area where there is a high incidence of adoles- cent pregnancy;
p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
...

p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001349:
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p.001351: 1351
p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
p.001351: (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents
p.001351: or guardians of any unemancipated minor requesting services from the applicant and, except as provided in
p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001351: (ii) in the case of a pregnant unemancipated minor re- questing services from the applicant, the applicant will no-
p.001351: tify the parents or guardians of such minor under clause
p.001351: (i) within a reasonable period of time;
p.001351: (B) assurances that the applicant will not notify or request the permission of the parents or
p.001351: guardian of any unemancipated minor without the consent of the minor—
p.001351: (i) who solely is requesting from the applicant preg- nancy testing or testing or treatment for venereal
p.001351: disease;
p.001351: (ii) who is the victim of incest involving a parent; or
p.001351: (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor
p.001351: by blood certifies to the grantee that notification of the parents or guardians of such minor would result in
p.001351: physical injury to such minor; and
p.001351: (C) assurances that the applicant will not require, with re- spect to the provision of services, the permission of the
p.001351: parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to
p.001351: compel such minor to have an abortion;
p.001351: (23) assurances that primary emphasis for services sup- ported under this title shall be given to
p.001351: adolescents seventeen and under who are not able to obtain needed assistance through other means;
p.001351: (24) assurances that funds received under this title shall supplement and not supplant funds received
p.001351: from any other Federal, State, or local program or any private sources of funds; and
p.001351: (25) a plan for the conduct of, and assurances that the ap- plicant will conduct, evaluations of the
p.001351: effectiveness of the services supported under this title in accordance with sub- section (b).
p.001351: (b)(1) Each grantee which receives funds for a demonstration project for services under this title shall expend
p.001351: at least 1 per cen- tum but not in excess of 5 per centum of the amounts received under this title for
p.001351: the conduct of evaluations of the services sup- ported under this title. The Secretary may, for a particular
p.001351: grantee upon good cause shown, waive the provisions of the preceding sen- tence with respect to the amounts to
p.001351: be expended on evaluations, but may not waive the requirement that such evaluations be con- ducted.
p.001351: (2) Evaluations required by paragraph (1) shall be conducted by an organization or entity which is
p.001351: independent of the grantee providing services supported under this title. To assist in con- ducting the
p.001351: evaluations required by paragraph (1), each grantee shall develop a working relationship with a college or
p.001351: university lo- cated in the grantee’s State which will provide or assist in pro-
p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001351:
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p.001351: Sec. 2007 PUBLIC HEALTH SERVICE ACT 1352
p.001351:
p.001351: viding monitoring and evaluation of services supported under this title unless no college or university in the
p.001351: grantee’s State is willing or has the capacity to provide or assist in providing such moni- toring and
p.001351: assistance.
p.001351: (3) The Secretary may provide technical assistance with re- spect to the conduct of evaluations required
p.001351: under this subsection to any grantee which is unable to develop a working relationship with a college or
p.001351: university in the applicant’s State for the reasons described in paragraph (2).
p.001351: (c) Each grantee which receives funds for a demonstration project for services under this title shall
p.001351: make such reports con- cerning its use of Federal funds as the Secretary may require. Re- ports shall include, at
p.001351: such times as are considered appropriate by the Secretary, the results of the evaluations of the services
p.001351: sup- ported under this title.
p.001351: (d)(1) A grantee shall periodically notify the Secretary of the exact number of instances in which a
p.001351: grantee does not notify the parents or guardians of a pregnant unemancipated minor under subsection
p.001351: (a)(22)(B)(iii).
p.001351: (2) For purposes of subsection (a)(22)(B)(iii), the term ‘‘adult’’ means an adult as defined by State law.
p.001351: (e) Each applicant shall provide the Governor of the State in which the applicant is located a copy of each
p.001351: application submitted to the Secretary for a grant for a demonstration project for services under this title. The
p.001351: Governor shall submit to the applicant com- ments on any such application within the period of sixty
p.001351: days be- ginning on the day when the Governor receives such copy. The ap- plicant shall include the comments of
p.001351: the Governor with such ap- plication.
p.001351: (f) No application submitted for a grant for a demonstration project for care services under this title
p.001351: may be approved unless the Secretary is satisfied that core services shall be available through the
p.001351: applicant within a reasonable time after such grant is received.
p.001351:
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p.001351: January 30, 2020
p.001351: COORDINATION OF FEDERAL AND STATE PROGRAMS
p.001351: SEC. 2007. ø300z–6¿ (a) The Secretary shall coordinate Federal policies and programs providing services relating to the
p.001351: prevention of adolescent sexual relations and initial and recurrent adolescent pregnancies and providing
p.001351: care services for pregnant adolescents. In achieving such coordination, the Secretary shall—
p.001351: (1) require grantees who receive funds for demonstration projects for services under this title to report
...

p.001353: (b)(1) Funds provided for research under this section may be used for descriptive or explanatory surveys,
p.001353: longitudinal studies, or
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p.001353: January 30, 2020
p.001353: 1 So in law. Probably should be ‘‘dissemination’’.
p.001353: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001353: Sec. 2008 PUBLIC HEALTH SERVICE ACT 1354
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p.001353: limited demonstration projects for services that are for the purpose of increasing knowledge and understanding of
p.001353: the matters de- scribed in paragraphs (4) and (5) of section 2001(b).
p.001353: (2) Funds provided under this section may not be used for the purchase or improvement of land, or the purchase,
p.001353: construction, or permanent improvement (other than minor remodeling) of any building or facility.
p.001353: (c) The Secretary may not make any grant or enter into any contract to support research or
p.001353: dissemination activities under this section unless—
p.001353: (1) the Secretary has received an application for such grant or contract which is in such form and
p.001353: which contains such information as the Secretary may by regulation require;
p.001353: (2) the applicant has demonstrated that the applicant is capable of conducting one or more of the types
p.001353: of research or dissemination activities described in paragraph (4), (5), or (6) of section 2001(b); and
p.001353: (3) in the case of an application for a research project, the panel established by subsection (e)(2) has determined
p.001353: that the project is of scientific merit.
p.001353: (d) The Secretary shall, where appropriate, coordinate research and dissemination activities carried out under this
p.001353: section with re- search and dissemination activities carried out by the National In- stitutes of Health.
p.001353: (e)(1) The Secretary shall establish a system for the review of applications for grants and contracts
p.001353: under this section. Such sys- tem shall be substantially similar to the system for scientific peer review
p.001353: of the National Institutes of Health and shall meet the re- quirements of paragraphs (2) and (3).
p.001353: (2) In establishing the system required by paragraph (1), the Secretary shall establish a panel to review
p.001353: applications under this section. Not more than 25 per centum of the members of the panel shall be physicians. The
p.001353: panel shall meet as often as may be nec- essary to facilitate the expeditious review of applications under this
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p.001359: death associ- ated with the administration of a vaccine before November 15, 1988, such person may not file a petition
p.001359: under subsection (b) for such injury or death.
p.001359: (7) If in a civil action brought against a vaccine adminis- trator or manufacturer for a vaccine-related
p.001359: injury or death damages are awarded under a judgment of a court or a settle- ment of such action, the person
p.001359: who brought such action may not file a petition under subsection (b) for such injury or death.
p.001359: (8) If on the effective date of this part there was pending an appeal or rehearing with respect to a
p.001359: civil action brought against a vaccine administrator or manufacturer and if the outcome of the last
p.001359: appellate review of such action or the last rehearing of such action is the denial of damages for a vaccine-
p.001359: related injury or death, the person who brought such action may file a petition under subsection (b)
p.001359: for such injury or death.
p.001359: (9) This subsection applies only to a person who has sus- tained a vaccine-related injury or death and
p.001359: who is qualified to file a petition for compensation under the Program.
p.001359: (10) The Clerk of the United States Claims Court is au- thorized to continue to receive, and forward,
p.001359: petitions for com- pensation for a vaccine-related injury or death associated with the administration of a vaccine on
p.001359: or after October 1, 1992.
p.001359: (b) PETITIONERS.—
p.001359: (1)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal
p.001359: represent- ative of such person if such person is a minor or is disabled, or the legal representative of
p.001359: any person who died as the result of the administration of a vaccine set forth in the Vaccine In- jury
p.001359: Table may, if the person meets the requirements of sub- section (c)(1), file a petition for compensation
p.001359: under the Pro- gram.
p.001359: (B) No person may file a petition for a vaccine-related in- jury or death associated with a vaccine
p.001359: administered before the effective date of this part if compensation has been paid under this subtitle for 3500
p.001359: petitions for such injuries or deaths.
p.001359: (2) Only one petition may be filed with respect to each ad- ministration of a vaccine. A covered vaccine administered
p.001359: to a pregnant woman shall constitute more than one administra- tion, one to the mother and one to each child (as
p.001359: such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.
p.001359:
p.001359:
p.001359:
p.001359: January 30, 2020
p.001359: 3 So in law. Probably should be followed by a comma.
p.001359: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
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p.001419: individuals infected with the etiologic agent for acquired immune deficiency syndrome.
p.001419: SEC. 2403. ø300dd–2¿ REQUIREMENT OF SUBMISSION OF DESCRIPTION OF INTENDED USES OF GRANT.
p.001419: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001419: (1) the State submits to the Secretary a description of the purposes for which the State intends to expend such
p.001419: payments for the fiscal year;
p.001419: (2) such description provides information relating to the services and activities to be provided,
p.001419: including a description of the manner in which such services and activities will be co- ordinated with any similar
p.001419: services and activities of public and private entities; and
p.001419: (3) such description includes information relating to (A) the process for determining which eligible
p.001419: individuals are medically dependent or chronically dependent and (B) the proc- ess for establishing written plans
p.001419: of care for the provision of home and community-based health services under this part.
p.001419: SEC. 2404. ø300dd–3¿ RESTRICTIONS ON USE OF GRANT.
p.001419: (a) IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year to a
p.001419: State unless the State agrees that the payments will not be expended—
p.001419: (1) to provide for items or services described in section 2401(d)(3);
p.001419: (2) to make cash payments to intended recipients of serv- ices;
p.001419: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001419: or to purchase major medical equipment; or
p.001419: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001419: of Federal funds.
p.001419: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2401(a) for a fiscal
p.001419: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments made to the
p.001419: State under such sec- tion for administrative expenses with respect to carrying out the purpose of this part.
p.001419: (c) LIMITATION ON TOTAL PAYMENTS.—
p.001419: (1) Before March 1, 1989, for fiscal year 1989 and before September 1, 1989, for fiscal year 1990, the
p.001419: Secretary shall de-
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001419:
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p.001419:
p.001419: Sec. 2405 PUBLIC HEALTH SERVICE ACT 1420
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p.001433: (6) with respect to such agreements, the application pro- vides assurances of compliance satisfactory to
p.001433: the Secretary; and
p.001433:
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p.001433: January 30, 2020
p.001433: (7) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001433: assurances, and information as the Secretary determines to be necessary to carry out this part.
p.001433: (b) OPPORTUNITY FOR PUBLIC COMMENT.—The Secretary may not make payments under section 2501(a) for a
p.001433: fiscal year unless the State involved agrees that, in developing and carrying out the description required
p.001433: in subsection (a), the State will provide public notice with respect to the description (including any revisions) and
p.001433: will facilitate comments from interested persons.
p.001433: SEC. 2504. ø300ee–14¿ RESTRICTIONS ON USE OF GRANT.
p.001433: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless
p.001433: the State involved agrees that the payments will not be expended—
p.001433: (1) to provide inpatient services;
p.001433: (2) to make cash payments to intended recipients of serv- ices;
p.001433: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001433: or to purchase major medical equipment; or
p.001433: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001433: of Federal funds.
p.001433: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2501(a) for a fiscal
p.001433: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments for
p.001433: administrative expenses with respect to carrying out the purpose described in section 2501(b).
p.001433: SEC. 2505. ø300ee–15¿ REQUIREMENT OF REPORTS AND AUDITS BY STATES.
p.001433: (a) REPORTS.—The Secretary may not make payments under section 2501(a) for a fiscal year unless the State
p.001433: involved agrees to prepare and submit to the Secretary an annual report in such form and containing such information as
p.001433: the Secretary determines to be necessary for—
p.001433: (1) securing a record and a description of the purposes for which payments received by the State pursuant to such
p.001433: section were expended and of the recipients of such payments;
p.001433: (2) determining whether the payments were expended in accordance with the needs within the State required
p.001433: to be identified pursuant to section 2503(a)(2);
p.001433: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001433:
p.001433:
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p.001433: Sec. 2506 PUBLIC HEALTH SERVICE ACT 1434
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p.001437:
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p.001437: January 30, 2020
p.001437:
p.001437: SEC. 2508. ø300ee–18¿ FAILURE TO COMPLY WITH AGREEMENTS.
p.001437: (a) REPAYMENT OF PAYMENTS.—
p.001437: (1) The Secretary may, subject to subsection (c), require a State to repay any payments received by the
p.001437: State under sec- tion 2501(a) that the Secretary determines were not expended by the State in accordance
p.001437: with the agreements required to be contained in the application submitted by the State pursuant to section
p.001437: 2503.
p.001437: (2) If a State fails to make a repayment required in para- graph (1), the Secretary may offset the amount of
p.001437: the repay- ment against the amount of any payment due to be paid to the State under section 2501(a).
p.001437: (b) WITHHOLDING OF PAYMENTS.—
p.001437: (1) The Secretary may, subject to subsection (c), withhold payments due under section 2501(a) if the
p.001437: Secretary deter- mines that the State involved is not expending amounts re- ceived under such section in
p.001437: accordance with the agreements required to be contained in the application submitted by the State pursuant
p.001437: to section 2503.
p.001437: (2) The Secretary shall cease withholding payments from a State under paragraph (1) if the Secretary
p.001437: determines that there are reasonable assurances that the State will expend amounts received under section
p.001437: 2501(a) in accordance with the agreements referred to in such paragraph.
p.001437: (3) The Secretary may not withhold funds under para- graph (1) from a State for a minor failure to
p.001437: comply with the agreements referred to in such paragraph.
p.001437: (c) OPPORTUNITY FOR HEARING.—Before requiring repayment of payments under subsection (a)(1), or withholding
p.001437: payments under subsection (b)(1), the Secretary shall provide to the State an oppor- tunity for a hearing conducted
p.001437: within the State.
p.001437: (d) PROMPT RESPONSE TO SERIOUS ALLEGATIONS.—The Sec- retary shall promptly respond to any complaint of a
p.001437: substantial or serious nature that a State has failed to expend amounts received under section 2501(a) in
p.001437: accordance with the agreements required to be contained in the application submitted by the State pursuant to
p.001437: section 2503.
p.001437: (e) INVESTIGATIONS.—
p.001437: (1) The Secretary shall conduct in several States in each fiscal year investigations of the expenditure
p.001437: of payments re- ceived by the States under section 2501(a) in order to evaluate compliance with the agreements
p.001437: required to be contained in the applications submitted to the Secretary pursuant to section 2503.
p.001437: (2) The Comptroller General of the United States may con- duct investigations of the expenditure of funds
p.001437: received under section 2501(a) by a State in order to ensure compliance with the agreements referred to in
p.001437: paragraph (1).
p.001437: (3) Each State, and each entity receiving funds from pay- ments made to a State under section 2501(a),
p.001437: shall make ap- propriate books, documents, papers, and records available to the Secretary and the
p.001437: Comptroller General of the United States, or any of their duly authorized representatives, for ex- amination,
p.001437: copying, or mechanical reproduction on or off the
...

p.001447:
p.001447: tion of) particular entities as recipients of any of the amounts provided in the grant.
p.001447: (B) REQUIRED AGREEMENTS.—An individual may serve on the planning council under paragraph (1) only if the in-
p.001447: dividual agrees that if the individual has a financial inter- est in an entity, if the individual is an employee of a
p.001447: public or private entity, or if the individual is a member of a pub- lic or private organization, and such entity or
p.001447: organization is seeking amounts from a grant under section 2601(a), the individual will not, with respect to the
p.001447: purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the
p.001447: process of selecting entities to receive such amounts for such purpose.
p.001447: (C) COMPOSITION OF COUNCIL.—The following applies regarding the membership of a planning council under
p.001447: paragraph (1):
p.001447: (i) Not less than 33 percent of the council shall be individuals who are receiving HIV-related services
p.001447: pursuant to a grant under section 2601(a), are not offi- cers, employees, or consultants to any entity that re-
p.001447: ceives amounts from such a grant, and do not rep- resent any such entity, and reflect the demographics of the
p.001447: population of individuals with HIV/AIDS as deter- mined under paragraph (4)(A). For purposes of the preceding
p.001447: sentence, an individual shall be considered to be receiving such services if the individual is a par- ent of, or a
p.001447: caregiver for, a minor child who is receiv- ing such services.
p.001447: (ii) With respect to membership on the planning council, clause (i) may not be construed as having any effect on
p.001447: entities that receive funds from grants under any of parts B through F but do not receive funds from grants
p.001447: under section 2601(a), on officers or em- ployees of such entities, or on individuals who rep- resent
p.001447: such entities.
p.001447: (6) GRIEVANCE PROCEDURES.—A planning council under paragraph (1) shall develop procedures for addressing
p.001447: griev- ances with respect to funding under this subpart, including procedures for submitting grievances that
p.001447: cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning
p.001447: council and be consistent with the re- quirements of subsection (c).
p.001447: (7) PUBLIC DELIBERATIONS.—With respect to a planning council under paragraph (1), the following applies:
p.001447: (A) The council may not be chaired solely by an em- ployee of the grantee under section 2601(a).
p.001447: (B) In accordance with criteria established by the Sec- retary:
p.001447:
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p.001447: January 30, 2020
p.001447: (i) The meetings of the council shall be open to the public and shall be held only after adequate notice to
p.001447: the public.
p.001447: (ii) The records, reports, transcripts, minutes, agenda, or other documents which were made avail-
p.001447: able to or prepared for or by the council shall be avail-
p.001447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001447:
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p.001463: shall provide for the establishment of a clinical quality manage- ment program to assess the extent to which
p.001463: HIV health services provided to patients under the grant are con- sistent with the most recent Public
p.001463: Health Service guide- lines for the treatment of HIV/AIDS and related opportun- istic infection, and as
p.001463: applicable, to develop strategies for ensuring that such services are consistent with the guide- lines for
p.001463: improvement in the access to and quality of HIV health services.
p.001463: (B) USE OF FUNDS.—
p.001463: (i) IN GENERAL.—From amounts received under a grant awarded under this subpart for a fiscal year, the chief
p.001463: elected official of an eligible area may use for ac- tivities associated with the clinical quality manage- ment
p.001463: program required in subparagraph (A) not to ex- ceed the lesser of—
p.001463: (I) 5 percent of amounts received under the grant; or
p.001463: (II) $3,000,000.
p.001463: (ii) RELATION TO LIMITATION ON ADMINISTRATIVE EXPENSES.—The costs of a clinical quality manage- ment
p.001463: program under subparagraph (A) may not be considered administrative expenses for purposes of the limitation
p.001463: established in paragraph (1).
p.001463: (i) CONSTRUCTION.—A chief elected official may not use amounts received under a grant awarded under
p.001463: this subpart to purchase or improve land, or to purchase, construct, or perma- nently improve (other
p.001463: than minor remodeling) any building or other facility, or to make cash payments to intended recipients
p.001463: of services.
p.001463: SEC. 2605. ø300ff–15¿ APPLICATION.
p.001463: (a) IN GENERAL.—To be eligible to receive a grant under sec- tion 2601, an eligible area shall prepare
p.001463: and submit to the Sec- retary an application, in accordance with subsection (c) regarding a single
p.001463: application and grant award, at such time, in such form, and containing such information as the Secretary
p.001463: shall require, in- cluding assurances adequate to ensure—
p.001463: (1)(A) that funds received under a grant awarded under this subpart will be utilized to supplement not
p.001463: supplant State funds made available in the year for which the grant is award- ed to provide HIV-related
p.001463: services as described in section 2604(b)(1);
p.001463: (B) that the political subdivisions within the eligible area will maintain the level of expenditures by
p.001463: such political sub- divisions for HIV-related services as described in section 2604(b)(1) at a level
p.001463: that is equal to the level of such expendi- tures by such political subdivisions for the preceding fiscal year;
p.001463: and
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: the requirement of paragraph (1) if such State demonstrates to the satisfaction
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001475: PUBLIC HEALTH SERVICE ACT
p.001475: Sec. 2613
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p.001475:
p.001475: January 30, 2020
p.001475: of the Secretary that the population is receiving HIV-related health services through the State medicaid
p.001475: program under title XIX of the Social Security Act, the State children’s health in- surance program under
p.001475: title XXI of such Act, or other Federal or State programs.
p.001475: (f) CONSTRUCTION.—A State may not use amounts received under a grant awarded under section 2611 to purchase or
p.001475: improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or
p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
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p.001495: HIV health services.
p.001495: (ii) USE OF FUNDS.—
p.001495: (I) IN GENERAL.—From amounts received under a grant awarded under section 2611 for a fiscal year,
p.001495: a State may use for activities associ- ated with the clinical quality management pro- gram required in
p.001495: clause (i) not to exceed the lesser of—
p.001495: (aa) 5 percent of amounts received under the grant; or
p.001495: (bb) $3,000,000.
p.001495: (II) RELATION TO LIMITATION ON ADMINISTRA- TIVE EXPENSES.—The costs of a clinical quality management
p.001495: program under clause (i) may not be considered administrative expenses for purposes of the limitation
p.001495: established in subparagraph (A).
p.001495: (4) LIMITATION ON USE OF FUNDS.—Except as provided in paragraph (5), a State may not use more than a total of
p.001495: 15 per- cent of amounts received under a grant awarded under section 2611 for the purposes described in paragraphs (2)
p.001495: and (3).
p.001495: (5) EXCEPTION.—With respect to a State that receives the minimum allotment under subsection (a)(1) for a
p.001495: fiscal year, such State, from the amounts received under a grant awarded under section 2611 for such fiscal year
p.001495: for the activities de- scribed in paragraphs (2) and (3), may, notwithstanding para- graphs (2) through
p.001495: (4) 12, use not more than that amount re- quired to support one full-time-equivalent employee.
p.001495: (6) CONSTRUCTION.—A State may not use amounts re- ceived under a grant awarded under section 2611 to
p.001495: purchase or improve land, or to purchase, construct, or permanently im- prove (other than minor remodeling) any
p.001495: building or other fa- cility, or to make cash payments to intended recipients of serv- ices.
p.001495: (c) EXPEDITED DISTRIBUTION.—
p.001495:
p.001495:
p.001495:
p.001495:
p.001495:
p.001495: January 30, 2020
p.001495: 12 Section 203(e)(5) of Public Law 109–415 (120 Stat. 2795) struck ‘‘paragraphs (3)’’ and all that follows
p.001495: through ‘‘(5),’’ and inserted revised text. There were two references to ‘‘paragraphs (3)’’. The amendment was
p.001495: executed to the first such reference to reflect the probable intent of Congress.
p.001495: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001495:
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p.001495: Sec. 2619 PUBLIC HEALTH SERVICE ACT 1496
p.001495:
p.001495: (1) IN GENERAL.—Not less than 75 percent of the amounts received under a grant awarded to a State under section 2611
p.001495: shall be obligated to specific programs and projects and made available for expenditure not later than—
p.001495: (A) in the case of the first fiscal year for which amounts are received, 150 days after the
p.001495: receipt of such amounts by the State; and
p.001495: (B) in the case of succeeding fiscal years, 120 days after the receipt of such amounts by the State.
p.001495: (2) PUBLIC COMMENT.—Within the time periods referred to in paragraph (1), the State shall invite and receive public
p.001495: com- ment concerning methods for the utilization of such amounts.
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p.001509: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001511: PUBLIC HEALTH SERVICE ACT
p.001511: Sec. 2655
p.001511:
p.001511: (b) TECHNICAL ASSISTANCE.—The Secretary may, directly or through grants or contracts, provide technical
p.001511: assistance to non- profit private entities regarding the process of submitting to the Secretary applications
p.001511: for grants under section 2651, and may pro- vide technical assistance with respect to the planning, develop-
p.001511: ment, and operation of any program or service carried out pursuant to such section.
p.001511: (c) PLANNING AND DEVELOPMENT GRANTS.—
p.001511: (1) IN GENERAL.—The Secretary may provide planning grants to public and nonprofit private entities for
p.001511: purposes of—
p.001511: (A) enabling such entities to provide early intervention services; and
p.001511: (B) assisting the entities in expanding their capacity to provide HIV/AIDS-related health services,
p.001511: including early intervention services, in low-income communities and affected subpopulations that are underserved
p.001511: with respect to such services (subject to the condition that a grant pur- suant to this subparagraph may not be
p.001511: expended to pur- chase or improve land, or to purchase, construct, or perma- nently improve, other than minor
p.001511: remodeling, any building or other facility).
p.001511: (2) REQUIREMENT.—The Secretary may only award a grant to an entity under paragraph (1) if the Secretary
p.001511: determines that the entity will use such grant to assist the entity in quali- fying for a grant under section 2651.
p.001511: (3) PREFERENCE.—In awarding grants under paragraph (1), the Secretary shall give preference to entities that
p.001511: provide primary care services in rural areas or to underserved popu- lations.
p.001511: (4) AMOUNT AND DURATION OF GRANTS.—
p.001511: (A) EARLY INTERVENTION SERVICES.—A grant under paragraph (1)(A) may be made in an amount not to exceed
p.001511: $50,000.
p.001511: (B) CAPACITY DEVELOPMENT.—
p.001511: (i) AMOUNT.—A grant under paragraph (1)(B) may be made in an amount not to exceed $150,000.
p.001511: (ii) DURATION.—The total duration of a grant under paragraph (1)(B), including any renewal, may not
p.001511: exceed 3 years.
p.001511: (5) LIMITATION.—Not to exceed 5 percent of the amount appropriated for a fiscal year under section 2655 may be
p.001511: used to carry out this section.
p.001511: SEC. 2655. ø300ff–55¿ AUTHORIZATION OF APPROPRIATIONS.
p.001511: For the purpose of making grants under section 2651, there are authorized to be appropriated,
p.001511: $218,600,000 for fiscal year 2007, $226,700,000 for fiscal year 2008, $235,100,000 for fiscal year 2009,
p.001511: $246,855,000 for fiscal year 2010, $259,198,000 for fiscal year 2011, $272,158,000 for fiscal year 2012, and
p.001511: $285,766,000 for fiscal year 2013.
p.001511:
p.001511:
p.001511: January 30, 2020 As Amended Through P.L. 116-94,
p.001511: Enacted December 20, 2019
p.001511:
p.001511:
p.001511:
p.001511:
...

p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
p.001521: including programs under this title and programs at the Centers for Disease Control and Prevention, the
p.001521: Substance Abuse and Mental Health Services Administration, and other de- partmental agencies. Such report shall
p.001521: include a history of program activities within each relevant agency and a description of activi- ties
p.001521: conducted, people served and types of grantees funded, and shall collect and describe best practices in
p.001521: community outreach and capacity-building of community based organizations serving the communities that are
p.001521: disproportionately affected by HIV/AIDS.
p.001521: SEC. 2687. ø300ff–87¿ SEVERITY OF NEED INDEX.
p.001521: (a) DEVELOPMENT OF INDEX.—Not later than September 30, 2008, the Secretary shall develop and submit to
p.001521: the appropriate
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001523: PUBLIC HEALTH SERVICE ACT
p.001523: Sec. 2688
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p.001551: defined for the purposes of applying the regulations promulgated by the Secretary under part C of title
p.001551: XI of the Social Security Act and section 264 of the Health Insurance Portability and Accountability Act
p.001551: of 1996, as may be revised from time to time) consistent with subsection (a).
p.001551: (B) LIMITATION.—For purposes of subparagraph (A), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request only the minimum
p.001551: amount of in- formation necessary to accomplish the intended purpose.
p.001551: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request, but not require, that a
p.001551: participant or bene- ficiary undergo a genetic test if each of the following conditions is met:
p.001551:
p.001551:
p.001551:
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p.001551:
p.001551:
p.001551:
p.001551: January 30, 2020
p.001551: (A) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal
p.001551: Regula- tions, or equivalent Federal regulations, and any applica- ble State or local law or regulations
p.001551: for the protection of human subjects in research.
p.001551: (B) The plan or issuer clearly indicates to each partici- pant or beneficiary, or in the case of a minor child, to the
p.001551: legal guardian of such beneficiary, to whom the request is made that—
p.001551: (i) compliance with the request is voluntary; and
p.001551: (ii) non-compliance will have no effect on enroll- ment status or premium or contribution amounts.
p.001551: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001551: (D) The plan or issuer notifies the Secretary in writing that the plan or issuer is conducting activities pursuant to
p.001551: the exception provided for under this paragraph, including a description of the activities conducted.
p.001551: (E) The plan or issuer complies with such other condi- tions as the Secretary may by regulation require for activi-
p.001551: ties conducted under this paragraph.
p.001551: (d) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001551: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering health insurance coverage in
p.001551: connection
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001551:
p.001551:
p.001551:
p.001551:
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p.001551:
p.001551: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1552
p.001551:
p.001551: with a group health plan, shall not request, require, or pur- chase genetic information for underwriting
p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
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p.001609: PUBLIC HEALTH SERVICE ACT
p.001609: Sec. 2753
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p.001609: January 30, 2020
p.001609: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a health insurance issuer offering health insurance
p.001609: coverage in the individual market may request, but not require, that an in- dividual or a family member of such
p.001609: individual undergo a ge- netic test if each of the following conditions is met:
p.001609: (A) The request is made pursuant to research that complies with part 46 of title 45, Code of Federal
p.001609: Regula- tions, or equivalent Federal regulations, and any applica- ble State or local law or regulations
p.001609: for the protection of human subjects in research.
p.001609: (B) The issuer clearly indicates to each individual, or in the case of a minor child, to the legal guardian of
p.001609: such child, to whom the request is made that—
p.001609: (i) compliance with the request is voluntary; and
p.001609: (ii) non-compliance will have no effect on enroll- ment status or premium or contribution amounts.
p.001609: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001609: (D) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to
p.001609: the excep- tion provided for under this paragraph, including a de- scription of the activities conducted.
p.001609: (E) The issuer complies with such other conditions as the Secretary may by regulation require for activities
p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
...

p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
...

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p.000123: of the fiscal years 1995 through 2002.
p.000123: (2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For pur- poses of carrying out this section with respect to
p.000123: qualified health professionals serving in the Epidemic Intelligence Serv- ice, as authorized under section 317G, there
p.000123: is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.
p.000123: (d) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated for a fiscal year for contracts under subsection
p.000123: (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year
p.000123: for which the amounts were appropriated.
p.000123: SEC. 317G. ø247b–8¿ FELLOWSHIP AND TRAINING PROGRAMS.
p.000123: The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall
p.000123: establish fellowship and training programs to be conducted by such Centers to train individ- uals to develop skills
p.000123: in epidemiology, surveillance, laboratory anal- ysis, and other disease detection and prevention methods. Such
p.000123: programs shall be designed to enable health professionals and health personnel trained under such programs
p.000123: to work, after re- ceiving such training, in local, State, national, and international ef- forts toward the
p.000123: prevention and control of diseases, injuries, and disabilities. Such fellowships and training may be
p.000123: administered through the use of either appointment or nonappointment proce- dures.
p.000123:
p.000123:
p.000123:
p.000123:
p.000123:
p.000123: January 30, 2020
p.000123: DIABETES IN CHILDREN AND YOUTH
p.000123: SEC. 317H. ø247b–9¿ (a) SURVEILLANCE ON JUVENILE DIABE-
p.000123: TES.—The Secretary, acting through the Director of the Centers for
p.000123: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000123:
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p.000123: Sec. 317I PUBLIC HEALTH SERVICE ACT 124
p.000123:
p.000123: Disease Control and Prevention, shall develop a sentinel system to collect data on juvenile diabetes, including
p.000123: with respect to inci- dence and prevalence, and shall establish a national database for such data.
p.000123: (b) TYPE 2 DIABETES IN YOUTH.—The Secretary shall imple- ment a national public health effort to address
p.000123: type 2 diabetes in youth, including—
p.000123: (1) enhancing surveillance systems and expanding re- search to better assess the prevalence and
p.000123: incidence of type 2 diabetes in youth and determine the extent to which type 2 di- abetes is incorrectly
p.000123: diagnosed as type 1 diabetes among chil- dren; and
p.000123: (2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes
p.000123: including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia
p.000123: and improving existing glucometers that measure blood glucose.
p.000123: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000123: COMPILATION OF DATA ON ASTHMA
p.000123: SEC. 317I. ø247b–10¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for
p.000123: Disease Control and Pre- vention, shall—
p.000123: (1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and
p.000123: the quality of asthma management;
p.000123: (2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
p.000123: (3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma
p.000123: nationally.
p.000123: (b) SURVEILLANCE ACTIVITIES.—The Director of the Centers for Disease Control and Prevention, acting through the
p.000123: representative of the Director on the National Asthma Education Prevention Pro- gram Coordinating Committee, shall, in
...

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p.000265: January 30, 2020
p.000265:
p.000265: tablishes for the purposes of such employment a temporary abode.
p.000265: (B) SEASONAL AGRICULTURAL WORKER.—The term ‘‘sea- sonal agricultural worker’’ means an individual whose
p.000265: principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.
p.000265: (C) AGRICULTURE.—The term ‘‘agriculture’’ means farming in all its branches, including—
p.000265: (i) cultivation and tillage of the soil;
p.000265: (ii) the production, cultivation, growing, and har- vesting of any commodity grown on, in, or as an ad-
p.000265: junct to or part of a commodity grown in or on, the land; and
p.000265: (iii) any practice (including preparation and proc- essing for market and delivery to storage or to market or to
p.000265: carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an
p.000265: activity described in clause (ii).
p.000265: (h) HOMELESS POPULATION.—
p.000265: (1) IN GENERAL.—The Secretary may award grants for the purposes described in subsections (c), (e), and (f) for
p.000265: the plan- ning and delivery of services to a special medically under- served population comprised of homeless
p.000265: individuals, including grants for innovative programs that provide outreach and com- prehensive primary health
p.000265: services to homeless children and youth, children and youth at risk of homelessness, homeless veterans, and
p.000265: veterans at risk of homelessness.
p.000265: (2) REQUIRED SERVICES.—In addition to required primary health services (as defined in subsection (b)(1)), an
p.000265: entity that receives a grant under this subsection shall be required to pro- vide substance abuse services as a
p.000265: condition of such grant.
p.000265: (3) SUPPLEMENT NOT SUPPLANT REQUIREMENT.—A grant awarded under this subsection shall be expended to
p.000265: supple- ment, and not supplant, the expenditures of the health center and the value of in kind contributions
p.000265: for the delivery of serv- ices to the population described in paragraph (1).
p.000265: (4) TEMPORARY CONTINUED PROVISION OF SERVICES TO CER- TAIN FORMER HOMELESS INDIVIDUALS.—If any grantee
p.000265: under this subsection has provided services described in this section under the grant to a homeless
p.000265: individual, such grantee may, notwithstanding that the individual is no longer homeless as a result of
p.000265: becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual
p.000265: for not more than 12 months.
p.000265: (5) DEFINITIONS.—For purposes of this section:
...

p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
p.000283: targeted to parents, schools, daycare providers, patients;
p.000283: (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig-
p.000283: mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth;
p.000283: (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and
p.000283: related needs of people with disabilities; and
p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000283:
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000283: January 30, 2020
p.000283:
p.000283: (3) COORDINATION OF ACTIVITIES.—The Secretary shall en- sure that activities under this subsection are
p.000283: coordinated as appropriate with other agencies of the Public Health Service that carry out activities
p.000283: regarding epilepsy and seizure.
p.000283: (b) SEIZURE DISORDER; DEMONSTRATION PROJECTS IN MEDI-
p.000283: CALLY UNDERSERVED AREAS.—
p.000283: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
...

p.000487: SEC. 399. ø280c–6¿ PROJECTS TO IMPROVE MATERNAL, INFANT, AND CHILD HEALTH.
p.000487: (a) IN GENERAL.—
p.000487: (1) ESTABLISHMENT OF PROGRAM.—The Secretary, acting through the Administrator of the Health Resources and
p.000487: Serv- ices Administration, shall make grants to eligible entities to pay the Federal share of the cost of
p.000487: providing the services spec- ified in subsection (b) to families in which a member is—
p.000487: (A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
p.000487: (B) a child less than 3 years of age—
p.000487: (i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or ne- glect;
p.000487: or
p.000487: (ii) who has been prenatally exposed to maternal substance abuse.
p.000487: (2) MINIMUM PERIOD OF AWARDS; ADMINISTRATIVE CON- SULTATIONS.—
p.000487: (A) The Secretary shall award grants under paragraph
p.000487: (1) for periods of at least three years.
p.000487: (B) The Administrator of the Administration for Chil- dren, Youth, and Families and the Director of the National
p.000487: Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines
p.000487: and funding priorities under this section.
p.000487: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000487: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000487: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000487: Social Security Act for the State involved—
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: Sec. 399 PUBLIC HEALTH SERVICE ACT 488
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p.000487: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
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p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
p.000491: (A) conduct evaluations to determine the effectiveness of projects under subsection (a) in reducing the
p.000491: incidence of children born with health or developmental complica- tions, the incidence among children less
p.000491: than 3 years of age of such complications, and the incidence of child abuse and neglect; and
p.000491: (B) not less than once during each 3-year period, pre- pare and submit to the appropriate committees of
p.000491: Con- gress a report concerning the results of such evaluations.
p.000491: (2) CONTENTS.—The evaluations conducted under para- graph (1) shall—
p.000491: (A) include a summary of the data contained in the annual reports submitted under subsection (m);
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000493: PUBLIC HEALTH SERVICE ACT
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p.000493: SEC. 399A. ø280d¿ GRANTS FOR SERVICES FOR CHILDREN OF SUB-
p.000493: STANCE ABUSERS. 94
p.000493: (a) ESTABLISHMENT.—
p.000493: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.000493: Administra- tion, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000493: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000493: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000493: substance abuser; and
p.000493: (C) to identify such children and such families.
p.000493: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000493: and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted
p.000493: regarding the pro- mulgation of program guidelines and funding priorities under this section.
p.000493: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000493: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000493: case of any service under such paragraph that is covered in the State plan approved under title XIX of the
p.000493: Social Security Act for the State involved—
p.000493: (i) the entity involved will provide the service di- rectly, and the entity has entered into a
p.000493: participation agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000493: (ii) the entity will enter into an agreement with an organization under which the organization will pro- vide
p.000493: the service, and the organization has entered into such a participation agreement and is qualified to re- ceive
p.000493: such payments.
p.000493: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000493: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000493: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000493: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000493: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
...

p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499:
p.000499: NOTE: ƒFor the convenience of the reader, the following indicates the probable intent of the Congress by showing
p.000499: section 399A as the section would appear if the amendments described in section 3106 of Public Law 106–310
p.000499: (114 Stat. 1175) were executed to section 399A, rather than to section 399D as instructed by such
p.000499: section 3106, including the amendment that redesignates the section as sec- tion 519 (toward the purpose of
p.000499: transferring the section to title V of this Act). See footnote on page 619.≈
p.000499: SEC. 519. ƒ280d≈ GRANTS FOR SERVICES FOR CHILDREN OF SUB- STANCE ABUSERS.
p.000499: (a) ESTABLISHMENT.—
p.000499: (1) IN GENERAL.—The Secretary, acting through the Admin- istrator of the Substance Abuse and Mental Health Services Ad-
p.000499: ministration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
p.000499: (A) to provide the services described in subsection (b) to children of substance abusers;
p.000499: (B) to provide the applicable services described in sub- section (c) to families in which a member is a
p.000499: substance abuser;
p.000499: (C) to identify such children and such families through youth service agencies, family social services, child
p.000499: care
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000501: PUBLIC HEALTH SERVICE ACT
p.000501: Sec. 399A
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
p.000501: (i)(I) the entity involved will provide the service di- rectly, and the entity has entered into a participation
p.000501: agreement under the State plan and is qualified to re- ceive payments under such plan; or
p.000501: (II) the entity will enter into an agreement with an organization under which the organization will provide the
p.000501: service, and the organization has entered into such a participation agreement and is qualified to receive such
p.000501: payments; and
p.000501: (ii) the entity will identify children who may be eli- gible for medical assistance under a State program under
p.000501: title XIX or XXI of the Social Security Act.
p.000501: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision
p.000501: of services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000501: agreement shall be waived by the Secretary if the organization does not, in providing health or mental
p.000501: health services, impose a charge or accept reimbursement available from any third- party payor, including
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p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
p.000503: families. Such training shall be to assist profes- sionals in recognizing the drug and alcohol problems of their
p.000503: clients and to enhance their skills in identifying and understanding the na- ture of substance abuse, and obtaining
p.000503: substance abuse early inter- vention, prevention and treatment resources.
p.000503: (e) ELIGIBLE ENTITIES.—The Secretary shall distribute the grants through the following types of entities:
p.000503: (1) Alcohol and drug early intervention, prevention or treat- ment programs, especially those providing treatment
p.000503: to preg- nant women and mothers and their children.
p.000503: (2) Public or nonprofit private entities that provide health or social services to disadvantaged
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p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
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p.000667: January 30, 2020
p.000667: agnosis, early and ongoing detection, prevention, and treat- ment of autism spectrum disorder across the
p.000667: lifespan. The cen- ters, as a group, shall conduct research including the fields of developmental
p.000667: neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral
p.000667: psychology, and clinical psychology.
p.000667: (3) SERVICES FOR PATIENTS.—
p.000667: (A) IN GENERAL.—A center under paragraph (1) may expend amounts provided under such paragraph to carry
p.000667: out a program to make individuals aware of opportunities to participate as subjects in research conducted by the cen-
p.000667: ters.
p.000667: (B) REFERRALS AND COSTS.—A program under sub- paragraph (A) may, in accordance with such criteria as the Director
p.000667: may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and
p.000667: such patient care costs as are required for research.
p.000667: (C) AVAILABILITY AND ACCESS.—The extent to which a center can demonstrate availability and access to clinical
p.000667: services shall be considered by the Director in decisions about awarding grants to applicants which meet
p.000667: the sci- entific criteria for funding under this section.
p.000667: (D) REDUCING DISPARITIES.—The Director may con- sider, as appropriate, the extent to which a center can
p.000667: demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic,
p.000667: geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific
p.000667: criteria for funding under this section.
p.000667: (4) ORGANIZATION OF CENTERS.—Each center under para- graph (1) shall use the facilities of a single
p.000667: institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be
p.000667: prescribed by the Director.
p.000667: (5) NUMBER OF CENTERS; DURATION OF SUPPORT.—
p.000667: (A) IN GENERAL.—The Director shall provide for the establishment of not less than five centers under
p.000667: para- graph (1).
p.000667: (B) DURATION.—Support for a center established under paragraph (1) may be provided under this section for a pe- riod of
p.000667: not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the
p.000667: operations of such center have been reviewed by an ap- propriate technical and scientific peer review group estab-
p.000667: lished by the Director and if such group has recommended to the Director that such period should be extended.
p.000667: (c) FACILITATION OF RESEARCH.—The Director shall under sub- section (a)(1) provide for a program under which samples of
p.000667: tissues and genetic materials that are of use in research on autism spec- trum disorder are donated,
p.000667: collected, preserved, and made avail- able for such research. The program shall be carried out in accord- ance
p.000667: with accepted scientific and medical standards for the dona- tion, collection, and preservation of such
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p.000751: (b) RESEARCH PROGRAM.—The research program established under this subpart shall include support for biomedical and
p.000751: behav- ioral neuroscience and shall be designed to further the treatment and prevention of mental illness,
p.000751: the promotion of mental health, and the study of the psychological, social and legal factors that in- fluence
p.000751: behavior.
p.000751: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000751:
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p.000753: PUBLIC HEALTH SERVICE ACT
p.000753: Sec. 464T
p.000753:
p.000753: (c) COLLABORATION.—The Director of the Institute shall col- laborate with the Administrator of the Substance
p.000753: Abuse and Men- tal Health Services Administration in focusing the services re- search activities of the
p.000753: Institute and in disseminating the results of such research to health professionals and the general public.
p.000753: (d) INFORMATION WITH RESPECT TO SUICIDE.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall—
p.000753: (A) develop and publish information with respect to the causes of suicide and the means of preventing suicide;
p.000753: and
p.000753: (B) make such information generally available to the public and to health professionals.
p.000753: (2) YOUTH SUICIDE.—Information described in paragraph
p.000753: (1) shall especially relate to suicide among individuals under 24 years of age.
p.000753: (e) ASSOCIATE DIRECTOR FOR SPECIAL POPULATIONS.—
p.000753: (1) IN GENERAL.—The Director of the Institute shall des- ignate an Associate Director for Special Populations.
p.000753: (2) DUTIES.—The Associate Director for Special Popu- lations shall—
p.000753: (A) develop and coordinate research policies and pro- grams to assure increased emphasis on the mental
p.000753: health needs of women and minority populations;
p.000753: (B) support programs of basic and applied social and behavioral research on the mental health
p.000753: problems of women and minority populations;
p.000753: (C) study the effects of discrimination on institutions and individuals, including majority institutions
p.000753: and indi- viduals;
p.000753: (D) support and develop research designed to elimi- nate institutional discrimination; and
p.000753: (E) provide increased emphasis on the concerns of women and minority populations in training programs,
p.000753: service delivery programs, and research endeavors of the Institute.
p.000753: ASSOCIATE DIRECTOR FOR PREVENTION
p.000753: SEC. 464S. ø285p–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
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p.000845: available to the public.
p.000845: (e) CONSULTATION.—After consultation with the States and with appropriate national organizations, the
p.000845: Assistant Secretary shall use existing standards and best practices to develop uniform criteria for the
p.000845: collection of data, using the best available tech- nology, pursuant to this section.
p.000845: SEC. 506. ø290aa–5¿ GRANTS FOR THE BENEFIT OF HOMELESS INDIVID- UALS.
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts and cooperative agreements to community-based public
p.000845: and private nonprofit entities for the purposes of providing mental health and substance use disorder
p.000845: services for homeless individuals. In car- rying out this section, the Secretary shall consult with the
p.000845: Inter- agency Council on the Homeless, established under section 201 of the Stewart B. McKinney Homeless
p.000845: Assistance Act (42 U.S.C. 11311).
p.000845: (b) PREFERENCES.—In awarding grants, contracts, and coopera- tive agreements under subsection (a), the Secretary
p.000845: shall give a preference to—
p.000845: (1) entities that provide integrated primary health, sub- stance use disorder, and mental health services to
p.000845: homeless in- dividuals;
p.000845: (2) entities that demonstrate effectiveness in serving run- away, homeless, and street youth;
p.000845:
p.000845:
p.000845:
p.000845:
p.000845: January 30, 2020
p.000845: 4 The heading for paragraph (2) is the result of the amendment made by section 6004(6)(C) of Public Law
p.000845: 114–255. Such amendment probably should not have been made to strike ‘‘AN- NUAL SURVEYS’’ (initial cap and
p.000845: small caps) and instead should have been ‘‘Annual Surveys’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000845: (3) entities that have experience in providing substance use disorder and mental health services to
p.000845: homeless individ- uals;
p.000845: (4) entities that demonstrate experience in providing hous- ing for individuals in treatment for or in recovery from
p.000845: mental illness or a substance use disorder; and
p.000845: (5) entities that demonstrate effectiveness in serving homeless veterans.
p.000845: (c) SERVICES FOR CERTAIN INDIVIDUALS.—In awarding grants, contracts, and cooperative agreements under
p.000845: subsection (a), the Secretary shall not—
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
p.000861: under the Drug Free Schools and Communities Act of 1986;
p.000861: (9) support the development of model, innovative, commu- nity-based programs that reduce the risk of
p.000861: alcohol and drug abuse among young people and promote resiliency;
p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
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p.000863: programs to dissemi- nate the findings of the knowledge development and application, training and technical
p.000863: assistance programs, and targeted capacity response programs under this section to the general public and
p.000863: to health professionals. The Secretary shall make every effort to pro- vide linkages between the findings of supported
p.000863: projects and State agencies responsible for carrying out substance use disorder pre- vention and treatment
p.000863: programs.
p.000863: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000863: $211,148,000 for each of fiscal years 2018 through 2022.
p.000863: øSection 517 was repealed by section 9017 of Public Law 114–
p.000863: 255. Section 518 was repealed by section 3202(b) of Public Law 106–310 (114 Stat. 1210). Section 519A
p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
p.000863: (3) The term ‘‘youth’’ means persons under the age of 21.
p.000863: (4) The term ‘‘IOM report’’ means the report released in September 2003 by the National Research Council,
p.000863: Institute of Medicine, and entitled ‘‘Reducing Underage Drinking: A Collec- tive Responsibility’’.
p.000863: (b) SENSE OF CONGRESS.—It is the sense of the Congress that:
p.000863: (1) A multi-faceted effort is needed to more successfully ad- dress the problem of underage drinking in the
p.000863: United States. A coordinated approach to prevention, intervention, treatment, enforcement, and research is key to
p.000863: making progress. This Act recognizes the need for a focused national effort, and addresses particulars of the Federal
p.000863: portion of that effort, as well as Fed- eral support for State activities.
p.000863: (2) The Secretary of Health and Human Services shall con- tinue to conduct research and collect data on the
p.000863: short and long-range impact of alcohol use and abuse upon adolescent brain development and other organ
p.000863: systems.
p.000863: (3) States and communities, including colleges and univer- sities, are encouraged to adopt comprehensive
p.000863: prevention ap- proaches, including—
p.000863: (A) evidence-based screening, programs and curricula;
p.000863: (B) brief intervention strategies;
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: Sec. 519B PUBLIC HEALTH SERVICE ACT 864
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p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
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p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
p.000865: foundations, and alcohol bev- erage industry trade associations and companies.
p.000865: (F) ANNUAL REPORT.—
p.000865: (i) IN GENERAL.—The Secretary, on behalf of the Committee, shall annually submit to the Congress a report
p.000865: that summarizes—
p.000865: (I) all programs and policies of Federal agen- cies designed to prevent and reduce underage
p.000865: drinking;
p.000865: (II) the extent of progress in preventing and reducing underage drinking nationally;
p.000865: (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
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p.000865: (IV) such other information regarding under- age drinking as the Secretary determines to be ap- propriate.
p.000865: (ii) CERTAIN INFORMATION.—The report under clause (i) shall include information on the following:
p.000865: (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not
p.000865: limited to Monitoring the Future, Youth Risk Behavior Surveillance System, the Na- tional Survey on Drug
p.000865: Use and Health, and the Fatality Analysis Reporting System.
p.000865: (II) Measures of the availability of alcohol from commercial and non-commercial sources to underage
p.000865: populations.
p.000865: (III) Measures of the exposure of underage populations to messages regarding alcohol in ad- vertising and
p.000865: the entertainment media as re- ported by the Federal Trade Commission.
p.000865: (IV) Surveillance data, including information on the onset and prevalence of underage drinking, consumption
p.000865: patterns and the means of underage access. The Secretary shall develop a plan to im- prove the collection,
p.000865: measurement and consistency of reporting Federal underage alcohol data.
p.000865: (V) Any additional findings resulting from re- search conducted or supported under subsection (f).
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: (VI) Evidence-based best practices to prevent and reduce underage drinking and provide treat- ment services
p.000865: to those youth who need them.
p.000865: (2) ANNUAL REPORT ON STATE UNDERAGE DRINKING PRE- VENTION AND ENFORCEMENT ACTIVITIES.—
p.000865: (A) IN GENERAL.—The Secretary shall, with input and collaboration from other appropriate Federal agencies,
p.000865: States, Indian tribes, territories, and public health, con- sumer, and alcohol beverage industry groups,
p.000865: annually issue a report on each State’s performance in enacting, en- forcing, and creating laws, regulations, and
p.000865: programs to prevent or reduce underage drinking.
p.000865: (B) STATE PERFORMANCE MEASURES.—
p.000865: (i) IN GENERAL.—The Secretary shall develop, in consultation with the Committee, a set of measures to be used in
p.000865: preparing the report on best practices.
p.000865: (ii) CATEGORIES.—In developing these measures, the Secretary shall consider categories including, but not
p.000865: limited to:
p.000865: (I) Whether or not the State has comprehen- sive anti-underage drinking laws such as for the illegal
p.000865: sale, purchase, attempt to purchase, con- sumption, or possession of alcohol; illegal use of fraudulent ID;
p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
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p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: 867
p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
p.000867: (dd) underage drinking prevention pro- grams that target youth within the juvenile justice and child
p.000867: welfare systems; and
p.000867: (ee) other State efforts or programs as deemed appropriate.
p.000867: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (d) NATIONAL MEDIA CAMPAIGN TO PREVENT UNDERAGE DRINK-
p.000867: ING.—
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p.000867: (1) SCOPE OF THE CAMPAIGN.—The Secretary shall continue
p.000867: to fund and oversee the production, broadcasting, and evalua- tion of the national adult-oriented media
p.000867: public service cam- paign if the Secretary determines that such campaign is effec- tive in achieving the media
p.000867: campaign’s measurable objectives.
p.000867: (2) REPORT.—The Secretary shall provide a report to the Congress annually detailing the production,
p.000867: broadcasting, and evaluation of the campaign referred to in paragraph (1), and to detail in the report the
p.000867: effectiveness of the campaign in reduc- ing underage drinking, the need for and likely effectiveness of an expanded
p.000867: adult-oriented media campaign, and the feasi- bility and the likely effectiveness of a national
p.000867: youth-focused media campaign to combat underage drinking.
p.000867: (3) CONSULTATION REQUIREMENT.—In carrying out the media campaign, the Secretary shall direct the entity
p.000867: carrying out the national adult-oriented media public service campaign to consult with interested parties
p.000867: including both the alcohol beverage industry and public health and consumer groups. The progress of this
p.000867: consultative process is to be covered in the re- port under paragraph (2).
p.000867: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection,
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (e) INTERVENTIONS.—
p.000867: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000867:
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p.000867: Sec. 519B PUBLIC HEALTH SERVICE ACT 868
p.000867:
p.000867: (1) COMMUNITY-BASED COALITION ENHANCEMENT GRANTS TO PREVENT UNDERAGE DRINKING.—
p.000867: (A) AUTHORIZATION OF PROGRAM.—The Assistant Sec- retary for Mental Health and Substance Use, in consulta-
p.000867: tion with the Director of the Office of National Drug Con- trol Policy, shall award, if the Assistant Secretary
p.000867: deter- mines that the Department of Health and Human Services is not currently conducting activities that duplicate
p.000867: activi- ties of the type described in this subsection, ‘‘enhancement grants’’ to eligible entities to design, test,
p.000867: evaluate and dis- seminate effective strategies to maximize the effectiveness of community-wide approaches to
p.000867: preventing and reducing underage drinking. This subsection is subject to the avail- ability of appropriations.
p.000867: (B) PURPOSES.—The purposes of this paragraph are
p.000867: to—
p.000867: (i) prevent and reduce alcohol use among youth in communities throughout the United States;
p.000867: (ii) strengthen collaboration among communities, the Federal Government, and State, local, and tribal
p.000867: governments;
p.000867: (iii) enhance intergovernmental cooperation and coordination on the issue of alcohol use among youth;
p.000867: (iv) serve as a catalyst for increased citizen par- ticipation and greater collaboration among all
p.000867: sectors and organizations of a community that first dem- onstrates a long-term commitment to reducing
p.000867: alcohol use among youth;
p.000867: (v) disseminate to communities timely information regarding state-of-the-art practices and initiatives that have proven
p.000867: to be effective in preventing and reducing alcohol use among youth; and
p.000867: (vi) enhance, not supplant, effective local commu- nity initiatives for preventing and reducing alcohol use among
p.000867: youth.
p.000867: (C) APPLICATION.—An eligible entity desiring an en-
p.000867: hancement grant under this paragraph shall submit an ap- plication to the Assistant Secretary at such time, and
p.000867: in such manner, and accompanied by such information as the Assistant Secretary may require. Each application shall in-
p.000867: clude—
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p.000867: (i) a complete description of the entity’s current underage alcohol use prevention initiatives and how the
p.000867: grant will appropriately enhance the focus on un- derage drinking issues; or
p.000867: (ii) a complete description of the entity’s current initiatives, and how it will use this grant to
p.000867: enhance those initiatives by adding a focus on underage drink- ing prevention.
p.000867: (D) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000867: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph
p.000867: (C). Grants
p.000867: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000867:
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p.000869: PUBLIC HEALTH SERVICE ACT
p.000869: Sec. 519B
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p.000871: (G) ADMINISTRATIVE EXPENSES.—Not more than 5 per- cent of a grant under this paragraph may be expended for
p.000871: administrative expenses.
p.000871: (H) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this
p.000871: paragraph
p.000871: $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
p.000871: (f) ADDITIONAL RESEARCH.—
p.000871: (1) ADDITIONAL RESEARCH ON UNDERAGE DRINKING.—
p.000871: (A) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, collect data, and
p.000871: conduct or support research that is not duplicative of research cur- rently being conducted or supported by
p.000871: the Department of Health and Human Services, on underage drinking, with respect to the following:
p.000871: (i) Comprehensive community-based programs or strategies and statewide systems to prevent and re- duce
p.000871: underage drinking, across the underage years from early childhood to age 21, including programs funded and
p.000871: implemented by government entities, pub- lic health interest groups and foundations, and alcohol beverage companies and
p.000871: trade associations.
p.000871: (ii) Annually obtain and report more precise infor- mation than is currently collected on the scope of the
p.000871: underage drinking problem and patterns of underage alcohol consumption, including improved knowledge
p.000871: about the problem and progress in preventing, reduc- ing and treating underage drinking; as well as
p.000871: infor- mation on the rate of exposure of youth to advertising and other media messages encouraging and discour-
p.000871: aging alcohol consumption.
p.000871: (iii) Compiling information on the involvement of alcohol in unnatural deaths of persons ages 12 to 20
p.000871: in the United States, including suicides, homicides, and unintentional injuries such as falls, drownings,
p.000871: burns, poisonings, and motor vehicle crash deaths.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: Sec. 519B PUBLIC HEALTH SERVICE ACT 872
p.000871:
p.000871: (B) CERTAIN MATTERS.—The Secretary shall carry out activities toward the following objectives with respect
p.000871: to underage drinking:
p.000871: (i) Obtaining new epidemiological data within the national or targeted surveys that identify alcohol use
p.000871: and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a
p.000871: result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol
p.000871: exposure.
p.000871: (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
p.000871: paragraph (2) by—
p.000871: (A) providing training to health care providers;
p.000871: (B) disseminating best practices, including culturally and linguistically appropriate best practices, as
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p.000877: to be appropriated
p.000877: $5,988,000 for each of fiscal years 2018 through 2022.
p.000877: (d) ANNUAL REPORT.—Not later than 2 years after the date of enactment of this subsection, the Secretary
p.000877: shall submit to Con- gress a report on the activities carried out by the center established under subsection (a)
p.000877: during the year involved, including the poten- tial effects of such activities, and the States, organizations, and in-
p.000877: stitutions that have worked with the center.
p.000877: øSection 520D was repealed by section 9017 of Public Law 114–255.¿
p.000877: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: 879
p.000879: PUBLIC HEALTH SERVICE ACT
p.000879: Sec. 520E
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p.000879: January 30, 2020
p.000879: SEC. 520E. ø290bb–36¿ YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
p.000879: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance
p.000879: Use, shall award grants or cooperative agreements to eligible entities to—
p.000879: (1) develop and implement State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention strate- gies in schools, educational institutions, juvenile justice sys- tems, substance use
p.000879: disorder programs, mental health pro- grams, foster care systems, and other child and youth support organizations;
p.000879: (2) support public organizations and private nonprofit or- ganizations actively involved in State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies and in the development
p.000879: and continuation of State-spon- sored statewide youth suicide early intervention and preven- tion strategies;
p.000879: (3) provide grants to institutions of higher education to co- ordinate the implementation of State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies;
p.000879: (4) collect and analyze data on State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention serv- ices that can be used to monitor the effectiveness of such serv- ices and for research, technical
p.000879: assistance, and policy develop- ment; and
p.000879: (5) assist eligible entities, through State-sponsored state- wide or tribal youth suicide early
p.000879: intervention and prevention strategies, in achieving targets for youth suicide reductions under title V of the
p.000879: Social Security Act.
p.000879: (b) ELIGIBLE ENTITY.—
p.000879: (1) DEFINITION.—In this section, the term ‘‘eligible entity’’ means—
p.000879: (A) a State;
p.000879: (B) a public organization or private nonprofit organiza- tion designated by a State to develop or direct the
p.000879: State- sponsored statewide youth suicide early intervention and prevention strategy; or
p.000879: (C) a Federally recognized Indian tribe or tribal orga- nization (as defined in the Indian
p.000879: Self-Determination and Education Assistance Act) or an urban Indian organization (as defined in the Indian Health
p.000879: Care Improvement Act) that is actively involved in the development and continu- ation of a tribal youth
p.000879: suicide early intervention and pre- vention strategy.
p.000879: (2) LIMITATION.—In carrying out this section, the Secretary shall ensure that a State does not receive more
p.000879: than 1 grant or cooperative agreement under this section at any 1 time. For purposes of the preceding sentence, a
p.000879: State shall be considered to have received a grant or cooperative agreement if the eligi- ble entity
p.000879: involved is the State or an entity designated by the State under paragraph (1)(B). Nothing in this paragraph
p.000879: shall be construed to apply to entities described in paragraph (1)(C).
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000879:
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p.000879: Sec. 520E PUBLIC HEALTH SERVICE ACT 880
p.000879: (3) CONSIDERATION.—In awarding grants under this sec- tion, the Secretary shall take into consideration
p.000879: the extent of the need of the applicant, including the incidence and preva- lence of suicide in the
p.000879: State and among the populations of focus, including rates of suicide determined by the Centers for Disease
p.000879: Control and Prevention for the State or population of focus.
p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: January 30, 2020
p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: 881
p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
p.000881:
p.000881: that child-serving professionals and providers involved in early intervention and prevention services are properly
p.000881: trained in ef- fectively identifying youth who are at risk for suicide;
p.000881: (11) provide continuous training activities for child care professionals and community care providers on the
p.000881: latest youth suicide early intervention and prevention services practices and strategies;
p.000881: (12) conduct annual self-evaluations of outcomes and ac- tivities, including consulting with interested families
p.000881: and advo- cacy organizations;
p.000881: (13) provide services in areas or regions with rates of youth suicide that exceed the national average
p.000881: as determined by the Centers for Disease Control and Prevention; and
p.000881: (14) obtain informed written consent from a parent or legal guardian of an at-risk child before involving the
p.000881: child in a youth suicide early intervention and prevention program.
p.000881: (d) REQUIREMENT FOR DIRECT SERVICES.—Not less than 85 per- cent of grant funds received under this section shall be
p.000881: used to pro- vide direct services, of which not less than 5 percent shall be used for activities authorized under
p.000881: subsection (a)(3).
p.000881: (e) COORDINATION AND COLLABORATION.—
p.000881: (1) IN GENERAL.—In carrying out this section, the Sec- retary shall collaborate with relevant Federal agencies
p.000881: and sui- cide working groups responsible for early intervention and pre- vention services relating to youth suicide.
p.000881: (2) CONSULTATION.—In carrying out this section, the Sec- retary shall consult with—
p.000881: (A) State and local agencies, including agencies re- sponsible for early intervention and prevention
p.000881: services under title XIX of the Social Security Act, the State Chil- dren’s Health Insurance Program
p.000881: under title XXI of the Social Security Act, and programs funded by grants under title V of the Social Security Act;
p.000881: (B) local and national organizations that serve youth at risk for suicide and their families;
p.000881: (C) relevant national medical and other health and education specialty organizations;
p.000881: (D) youth who are at risk for suicide, who have sur- vived suicide attempts, or who are currently receiving
p.000881: care from early intervention services;
p.000881: (E) families and friends of youth who are at risk for suicide, who have survived suicide attempts, who
p.000881: are cur- rently receiving care from early intervention and preven- tion services, or who have completed
p.000881: suicide;
p.000881: (F) qualified professionals who possess the specialized knowledge, skills, experience, and relevant
p.000881: attributes needed to serve youth at risk for suicide and their families; and
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p.000881: January 30, 2020
p.000881: (G) third-party payers, managed care organizations, and related commercial industries.
p.000881: (3) POLICY DEVELOPMENT.—In carrying out this section, the Secretary shall—
p.000881: (A) coordinate and collaborate on policy development at the Federal level with the relevant
p.000881: Department of
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: Sec. 520E PUBLIC HEALTH SERVICE ACT 882
p.000881:
p.000881: Health and Human Services agencies and suicide working groups; and
p.000881: (B) consult on policy development at the Federal level with the private sector, including consumer, medical,
p.000881: sui- cide prevention advocacy groups, and other health and education professional-based organizations, with
p.000881: respect to State-sponsored statewide or tribal youth suicide early intervention and prevention strategies.
p.000881: (f) RULE OF CONSTRUCTION; RELIGIOUS AND MORAL ACCOMMO- DATION.—Nothing in this section shall be construed to
p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
p.000881: object based on the parents’ or legal guardians’ religious beliefs or moral objections.
p.000881: (g) EVALUATIONS AND REPORT.—
p.000881: (1) EVALUATIONS BY ELIGIBLE ENTITIES.—Not later than 18 months after receiving a grant or cooperative agreement
p.000881: under this section, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted
p.000881: by the entity con- cerning the effectiveness of the activities carried out under the grant or agreement.
p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
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p.000881: January 30, 2020
p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
p.000883: private nonprofit organizations, political subdivisions, consortia of political subdivi- sions, consortia of
p.000883: States, or Federally recognized Indian tribes or tribal organizations to design early intervention and
p.000883: prevention strategies that will complement the State-sponsored statewide or tribal youth suicide early
p.000883: intervention and prevention strategies developed pursuant to section 520E.
p.000883: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall ensure that activities under this
p.000883: section are coordi- nated with the relevant Department of Health and Human Services agencies and suicide working
p.000883: groups.
p.000883: (c) REQUIREMENTS.—A public organization, private nonprofit organization, political subdivision, consortium of
p.000883: political subdivi- sions, consortium of States, or federally recognized Indian tribe or tribal organization
p.000883: desiring a grant, contract, or cooperative agree- ment under this section shall demonstrate that the suicide preven-
p.000883: tion program such entity proposes will—
p.000883:
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p.000883: January 30, 2020
p.000883: 10 The probable intent of the Congress is that the heading be ‘‘SUICIDE PREVENTION FOR YOUTH’’. See the amendment
p.000883: described in section 3(b)(1)(A) of Public Law 108–355 (118 Stat. 1407). The amendment cannot be executed
p.000883: because the matter in the heading to be struck does not appear, as the amendatory instruction used the wrong
p.000883: font. The amendment referred to ‘‘CHILDREN AND ADOLESCENTS’’ rather than ‘‘CHILDREN AND ADOLESCENTS’’. (The
p.000883: amendment is directed to section ‘‘520E’’. Section 520E–1 above formerly was section 520E, and was redesignated by
p.000883: section 3(b)(2) of such Public Law.)
p.000883: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: Sec. 520E–1 PUBLIC HEALTH SERVICE ACT 884
p.000883:
p.000883: (1)(A) comply with the State-sponsored statewide early intervention and prevention strategy as developed
p.000883: under sec- tion 520E; and
p.000883: (B) in the case of a consortium of States, receive the sup- port of all States involved;
p.000883: (2) provide for the timely assessment, treatment, or refer- ral for mental health or substance abuse
p.000883: services of youth at risk for suicide;
p.000883: (3) be based on suicide prevention practices and strategies that are adapted to the local community;
p.000883: (4) integrate its suicide prevention program into the exist- ing health care system in the community including
p.000883: general, mental, and behavioral health services, and substance abuse services;
p.000883: (5) be integrated into other systems in the community that address the needs of youth including the school
p.000883: systems, edu- cational institutions, juvenile justice system, substance abuse programs, mental health
p.000883: programs, foster care systems, and community child and youth support organizations;
p.000883: (6) use primary prevention methods to educate and raise awareness in the local community by disseminating
p.000883: evidence- based information about suicide prevention;
p.000883: (7) include suicide prevention, mental health, and related information and services for the families and
p.000883: friends of those who completed suicide, as needed;
p.000883: (8) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000883: (9) conduct annual self-evaluations of outcomes and activi- ties, including consulting with interested families and
p.000883: advocacy organizations; 11
p.000883: (10) ensure that staff used in the program are trained in suicide prevention and that professionals
p.000883: involved in the sys- tem of care have received training in identifying persons at risk of suicide.
p.000883: (d) USE OF FUNDS.—Amounts provided under a grant or coop- erative agreement under this section shall be
p.000883: used to supplement, and not supplant, Federal and non-Federal funds available for car- rying out the activities
p.000883: described in this section. Applicants shall provide financial information to demonstrate compliance with
p.000883: this section.
p.000883: (e) CONDITION.—An applicant for a grant or cooperative agree- ment under subsection (a) shall demonstrate to the
p.000883: Secretary that the application complies with the State-sponsored statewide early intervention and prevention
p.000883: strategy as developed under section 520E and the applicant has the support of the local community and relevant
p.000883: public health officials.
p.000883: (f) SPECIAL POPULATIONS.—In awarding grants and cooperative agreements under subsection (a), the Secretary shall
p.000883: ensure that such awards are made in a manner that will focus on the needs of communities or groups
p.000883: that experience high or rapidly rising rates of suicide.
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p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
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p.000885:
p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
p.000885: with the Secretary of Education, may award grants on a competitive basis to institutions of higher education
p.000885: to enhance services for students with mental health or substance use disorders that can lead to school
...

p.000939: $100,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and
p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
p.000939: (2) the development of knowledge with regard to evidence- based practices for identifying and treating mental,
p.000939: behavioral, and biological disorders of children and youth resulting from witnessing or experiencing a
p.000939: traumatic event.
p.000939: (b) PRIORITIES.—In awarding grants, contracts or cooperative agreements under subsection (a)(2) (related to
p.000939: the development of knowledge on evidence-based practices for treating mental, behav- ioral, and biological
p.000939: disorders associated with psychological trau- ma), the Secretary shall give priority to universities,
p.000939: hospitals, mental health agencies, and other programs that have established clinical expertise and research
p.000939: experience in the field of trauma-re- lated mental disorders.
p.000939: (c) CHILD OUTCOME DATA.—The NCTSI coordinating center de- scribed in subsection (a)(1) shall collect, analyze, report,
p.000939: and make publicly available, as appropriate, NCTSI-wide child treatment process and outcome data regarding
p.000939: the early identification and de- livery of evidence-based treatment and services for children and families
p.000939: served by the NCTSI grantees.
p.000939: (d) TRAINING.—The NCTSI coordinating center shall facilitate the coordination of training initiatives in
p.000939: evidence-based and trau-
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p.000941: 941
p.000941: PUBLIC HEALTH SERVICE ACT
p.000941: Sec. 591
p.000941:
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p.000943: facilities, and other health care professionals and patients, shall promulgate regulations that require
p.000943: facilities to which the Protection and Advocacy for Mentally Ill Individuals Act of 1986 20 (42 U.S.C. 10801 et
p.000943: seq.) applies, to meet the requirements of sub- section (b).
p.000943: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require that—
p.000943: (1) facilities described in subsection (a) ensure that there is an adequate number of qualified professional
p.000943: and supportive staff to evaluate patients, formulate written individualized, comprehensive treatment plans,
p.000943: and to provide active treat- ment measures;
p.000943: (2) appropriate training be provided for the staff of such facilities in the use of restraints and any
p.000943: alternatives to the use of restraints; and
p.000943: (3) such facilities provide complete and accurate notifica- tion of deaths, as required under section 592(a).
p.000943: (c) ENFORCEMENT.—A facility to which this part applies that fails to comply with any requirement of this part,
p.000943: including a fail- ure to provide appropriate training, shall not be eligible for partici- pation in any program
p.000943: supported in whole or in part by funds ap- propriated to any Federal department or agency.
p.000943:
p.000943: PART I—REQUIREMENT RELATING TO THE RIGHTS OF RESIDENTS OF CERTAIN NON- MEDICAL, COMMUNITY-BASED
p.000943: FACILITIES FOR CHILDREN AND YOUTH
p.000943:
p.000943: SEC. 595. ø290jj¿ REQUIREMENT RELATING TO THE RIGHTS OF RESI- DENTS OF CERTAIN NON-MEDICAL,
p.000943: COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH.
p.000943: (a) PROTECTION OF RIGHTS.—
p.000943: (1) IN GENERAL.—A public or private non-medical, commu- nity-based facility for children and youth (as defined in
p.000943: regula- tions to be promulgated by the Secretary) that receives support
p.000943:
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p.000943: January 30, 2020
p.000943: 21 Section 593 appears according to the probable intent of the Congress. Section 3207 of Public Law 106–310 (114 Stat.
p.000943: 1196) added sections 591 and 592, and closing quotations were provided at the end of section 592. Immediately following
p.000943: that section, however, section 593 appeared in quotations, and closing quotations were provided at the end of the
p.000943: section. The probable intent of the Congress is that closing quotations should not have been provided at
p.000943: the end of section 592.
p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000943: Sec. 595 PUBLIC HEALTH SERVICE ACT 944
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p.000943: in any form from any program supported in whole or in part with funds appropriated under this Act
p.000943: shall protect and pro- mote the rights of each resident of the facility, including the right to be free
p.000943: from physical or mental abuse, corporal punish- ment, and any restraints or involuntary seclusions imposed for purposes
p.000943: of discipline or convenience.
p.000943: (2) NONAPPLICABILITY.—Notwithstanding this part, a facil- ity that provides inpatient psychiatric treatment
p.000943: services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and (h)
p.000943: of section 1905 of the Social Secu- rity Act, shall comply with the requirements of part H.
p.000943: (3) APPLICABILITY OF MEDICAID PROVISIONS.—A non-med- ical, community-based facility for children and
p.000943: youth funded under the Medicaid program under title XIX of the Social Secu- rity Act shall continue to meet all
p.000943: existing requirements for participation in such program that are not affected by this part.
p.000943: (b) REQUIREMENTS.—
p.000943: (1) IN GENERAL.—Physical restraints and seclusion may only be imposed on a resident of a facility
p.000943: described in sub- section (a) if—
p.000943: (A) the restraints or seclusion are imposed only in emergency circumstances and only to ensure the imme-
p.000943: diate physical safety of the resident, a staff member, or others and less restrictive interventions have
p.000943: been deter- mined to be ineffective; and
p.000943: (B) the restraints or seclusion are imposed only by an individual trained and certified, by a State-recognized body (as
p.000943: defined in regulation promulgated by the Secretary) and pursuant to a process determined appropriate by
p.000943: the State and approved by the Secretary, in the prevention and use of physical restraint and seclusion,
p.000943: including the needs and behaviors of the population served, relationship building, alternatives to restraint and
p.000943: seclusion, de-esca- lation methods, avoiding power struggles, thresholds for restraints and seclusion, the
p.000943: physiological and psycho- logical impact of restraint and seclusion, monitoring phys- ical signs of distress
p.000943: and obtaining medical assistance, legal issues, position asphyxia, escape and evasion tech- niques, time
p.000943: limits, the process for obtaining approval for continued restraints, procedures to address problematic re-
...

p.000943: certifi- cation of facility personnel in the skills and competencies referred in paragraph (1)(B), the facility
p.000943: involved shall de- velop and implement an interim procedure that meets the requirements of subparagraph (B).
p.000943: (B) REQUIREMENTS.—A procedure developed under subparagraph (A) shall—
p.000943: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000945: 945
p.000945: PUBLIC HEALTH SERVICE ACT
p.000945: Sec. 595
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p.000945: (i) ensure that a supervisory or senior staff person with training in restraint and seclusion who is com-
p.000945: petent to conduct a face-to-face assessment (as defined in regulations promulgated by the Secretary), will as-
p.000945: sess the mental and physical well-being of the child or youth being restrained or secluded and assure that the
p.000945: restraint or seclusion is being done in a safe manner;
p.000945: (ii) ensure that the assessment required under clause (i) take place as soon as practicable, but in no
p.000945: case later than 1 hour after the initiation of the re- straint or seclusion; and
p.000945: (iii) ensure that the supervisory or senior staff person continues to monitor the situation for the dura- tion
p.000945: of the restraint and seclusion.
p.000945: (3) LIMITATIONS.—
p.000945: (A) IN GENERAL.—The use of a drug or medication that is used as a restraint to control behavior or restrict
p.000945: the resident’s freedom of movement that is not a standard treatment for the resident’s medical or
p.000945: psychiatric condi- tion in nonmedical community-based facilities for children and youth described in subsection
p.000945: (a)(1) is prohibited.
p.000945: (B) PROHIBITION.—The use of mechanical restraints in non-medical, community-based facilities for children and
p.000945: youth described in subsection (a)(1) is prohibited.
p.000945: (C) LIMITATION.—A non-medical, community-based fa- cility for children and youth described in subsection
p.000945: (a)(1) may only use seclusion when a staff member is continu- ously face-to-face monitoring the resident and
p.000945: when strong licensing or accreditation and internal controls are in place.
p.000945: (c) RULE OF CONSTRUCTION.—
p.000945: (1) IN GENERAL.—Nothing in this section shall be con- strued as prohibiting the use of restraints for
p.000945: medical immo- bilization, adaptive support, or medical protection.
p.000945: (2) CURRENT LAW.—This part shall not be construed to af- fect or impede any Federal or State law or
p.000945: regulations that provide greater protections than this part regarding seclusion and restraint.
p.000945: (d) DEFINITIONS.—In this section:
p.000945: (1) MECHANICAL RESTRAINT.—The term ‘‘mechanical re- straint’’ means the use of devices as a means of
p.000945: restricting a resident’s freedom of movement.
p.000945: (2) PHYSICAL ESCORT.—The term ‘‘physical escort’’ means the temporary touching or holding of the hand,
p.000945: wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.
p.000945: (3) PHYSICAL RESTRAINT.—The term ‘‘physical restraint’’ means a personal restriction that immobilizes or
p.000945: reduces the ability of an individual to move his or her arms, legs, or head freely. Such term does not include a
p.000945: physical escort.
p.000945: (4) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000945: term does not include a time out.
p.000945: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000945: Sec. 595A PUBLIC HEALTH SERVICE ACT 946
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p.000945: (5) TIME OUT.—The term ‘‘time out’’ means a behavior management technique that is part of an approved
p.000945: treatment program and may involve the separation of the resident from the group, in a non-locked setting,
p.000945: for the purpose of calming. Time out is not seclusion.
p.000945: SEC. 595A. ø290jj–1¿ REPORTING REQUIREMENT.
p.000945: Each facility to which this part applies shall notify the appro- priate State licensing or regulatory agency, as
p.000945: determined by the Secretary—
p.000945: (1) of each death that occurs at each such facility. A notifi- cation under this section shall include the name of the
p.000945: resident and shall be provided not later than 24 hours after the time of the individuals death; and
p.000945: (2) of the use of seclusion or restraints in accordance with regulations promulgated by the Secretary, in consultation
p.000945: with the States.
p.000945: SEC. 595B. ø290jj–2¿ REGULATIONS AND ENFORCEMENT.
p.000945: (a) TRAINING.—Not later than 6 months after the date of the enactment of this part, the Secretary,
p.000945: after consultation with ap- propriate State, local, public and private protection and advocacy
p.000945: organizations, health care professionals, social workers, facilities, and patients, shall promulgate regulations
p.000945: that—
p.000945: (1) require States that license non-medical, community- based residential facilities for children and youth to
p.000945: develop li- censing rules and monitoring requirements concerning behav- ior management practice that will ensure
p.000945: compliance with Fed- eral regulations and to meet the requirements of subsection (b);
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p.000945: (2) require States to develop and implement such licensing rules and monitoring requirements within 1 year after the
p.000945: pro- mulgation of the regulations referred to in the matter pre- ceding paragraph (1); and
p.000945: (3) support the development of national guidelines and standards on the quality, quantity, orientation and
p.000945: training, required under this part, as well as the certification or licen- sure of those staff responsible
p.000945: for the implementation of behav- ioral intervention concepts and techniques.
p.000945: (b) REQUIREMENTS.—The regulations promulgated under sub- section (a) shall require—
p.000945: (1) that facilities described in subsection (a) ensure that there is an adequate number of qualified
p.000945: professional and sup- portive staff to evaluate residents, formulate written individ- ualized, comprehensive
p.000945: treatment plans, and to provide active treatment measures;
p.000945: (2) the provision of appropriate training and certification of the staff of such facilities in the prevention and use
p.000945: of physical restraint and seclusion, including the needs and behaviors of the population served, relationship
p.000945: building, alternatives to re- straint, de-escalation methods, avoiding power struggles, thresholds for
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p.001035: maintain- ing a diverse health care workforce that is prepared to de- liver high-quality care, with an emphasis on
p.001035: primary care, in underserved areas or for health disparity populations, in collaboration with other Federal
p.001035: and State health care workforce development programs, the State workforce agency, and local workforce
p.001035: investment boards, and in health care safety net sites.
p.001035: (C) Prepare individuals to more effectively provide health services to underserved areas and health
p.001035: disparity populations through field placements or preceptorships in conjunction with community-based
p.001035: organizations, accred- ited primary care residency training programs, Federally qualified health centers, rural
p.001035: health clinics, public health departments, or other appropriate facilities.
p.001035: (D) Conduct and participate in interdisciplinary train- ing that involves physicians, physician assistants, nurse
p.001035: practitioners, nurse midwives, dentists, psychologists, pharmacists, optometrists, community health
p.001035: workers, public and allied health professionals, or other health pro- fessionals, as practicable.
p.001035: (E) Deliver or facilitate continuing education and in- formation dissemination programs for health care
p.001035: profes- sionals, with an emphasis on individuals providing care in underserved areas and for health disparity
p.001035: populations.
p.001035: (F) Propose and implement effective program and out- comes measurement and evaluation strategies.
p.001035: (G) Establish a youth public health program to expose and recruit high school students into health careers,
p.001035: with a focus on careers in public health.
p.001035: (2) INNOVATIVE OPPORTUNITIES.—An eligible entity may use amounts awarded under a grant under subsection
p.001035: (a)(1) or subsection (a)(2) to carry out any of the following activities:
p.001035: (A) Develop and implement innovative curricula in col- laboration with community-based accredited primary care
p.001035: residency training programs, Federally qualified health centers, rural health clinics, behavioral and mental
p.001035: health facilities, public health departments, or other appropriate facilities, with the goal of increasing
p.001035: the number of pri- mary care physicians and other primary care providers prepared to serve in underserved
p.001035: areas and health dis- parity populations.
p.001035: (B) Coordinate community-based participatory re- search with academic health centers, and facilitate
p.001035: rapid flow and dissemination of evidence-based health care infor- mation, research results, and best practices to
p.001035: improve quality, efficiency, and effectiveness of health care and health care systems within community
p.001035: settings.
p.001035: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: psychology, counseling, and school psychology) for the develop- ment and implementation of interdisciplinary
p.001047: training of psy- chology graduate students for providing behavioral health serv- ices, including trauma-informed
p.001047: care and substance use dis- order prevention and treatment services, as well as the devel- opment of
p.001047: faculty in health service psychology;
p.001047: (3) accredited master’s and doctoral degree programs of so- cial work for the development and implementation of
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p.001047: development of faculty in social work; and
p.001047: (4) State-licensed mental health nonprofit and for-profit or- ganizations to enable such organizations to pay
p.001047: for programs for preservice or in-service training in a behavioral health-re- lated paraprofessional field
p.001047: with preference for preservice or in-service training of paraprofessional child and adolescent mental
p.001047: health workers.
p.001047: (b) ELIGIBILITY REQUIREMENTS.—To be eligible for a grant under this section, an institution shall
p.001047: demonstrate—
p.001047: (1) an ability to recruit and place the students described in subsection (a) in areas with a high need
p.001047: and high demand population;
p.001047: (2) participation in the institutions’ programs of individ- uals and groups from different racial, ethnic,
p.001047: cultural, geo- graphic, religious, linguistic, and class backgrounds, and dif- ferent genders and sexual
p.001047: orientations;
p.001047: (3) knowledge and understanding of the concerns of the in- dividuals and groups described in paragraph (2), especially
p.001047: in- dividuals with mental disorder symptoms or diagnoses, par- ticularly children and adolescents, and
p.001047: transitional-age youth;
p.001047: (4) any internship or other field placement program as- sisted under the grant will prioritize cultural
p.001047: and linguistic competency; and
p.001047: (5) the institution will provide to the Secretary such data, assurances, and information as the Secretary may require.
p.001047: (c) INSTITUTIONAL REQUIREMENT.—For grants awarded under paragraphs (2) and (3) of subsection (a), at least 4 of
p.001047: the grant re- cipients shall be historically black colleges or universities or other minority-serving
p.001047: institutions.
p.001047: (d) PRIORITY.—In selecting grant recipients under this section, the Secretary shall give priority to—
p.001047: (1) programs that have demonstrated the ability to train psychology, psychiatry, and social work
p.001047: professionals to work in integrated care settings for purposes of recipients under paragraphs (1), (2), and
p.001047: (3) of subsection (a); and
p.001047: (2) programs for paraprofessionals that emphasize the role of the family and the lived experience of the
p.001047: consumer and family-paraprofessional partnerships for purposes of recipients under subsection (a)(4).
p.001047: (e) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Helping Families in Mental
p.001047: Health Crisis Reform Act of 2016, the Secretary shall include in the biennial re-
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001071: 1071
p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
p.001071: center-affili- ated treatment program), correctional facility or program, youth detention center or program,
p.001071: inpatient psychiatric facility, crisis stabilization unit, community health center, community mental health or
p.001071: other specialty community be- havioral health center, recovery center, school, community- based organization,
p.001071: telehealth platform, migrant health center, health program or facility operated by an Indian tribe or tribal
p.001071: organization, Federal medical facility, or any other facility as determined appropriate for purposes of this
p.001071: section by the Secretary.
p.001071: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $25,000,000
p.001071: for each of fiscal years 2019 through 2023.
p.001071: PART G—GENERAL PROVISIONS
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p.001071: SEC. 791. ø295j¿ PREFERENCES AND REQUIRED INFORMATION IN CER- TAIN PROGRAMS.
p.001071: (a) PREFERENCES IN MAKING AWARDS.—
p.001071: (1) IN GENERAL.—Subject to paragraph (2), in making awards of grants or contracts under any of
p.001071: sections 747 and 750, the Secretary shall give preference to any qualified appli- cant that—
p.001071: (A) has a high rate for placing graduates in practice settings having the principal focus of serving
p.001071: residents of medically underserved communities;
p.001071: (B) during the 2-year period preceding the fiscal year for which such an award is sought, has achieved a
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p.001197: $1 for each $2 of Federal funds provided under the grant.
p.001197: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions under paragraph (1) may be in cash
p.001197: or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal
p.001197: Government, or services as- sisted or subsidized to any significant extent by the Federal Government, may
p.001197: not be included in determining the amount of such contributions.
p.001197: (d) APPLICATION FOR GRANT.—The Secretary may make a grant under subsection (a) only if an application for the
p.001197: grant is sub- mitted to the Secretary and the application is in such form, is made in such manner, and
p.001197: contains such agreements, assurances, and information as the Secretary determines to be necessary to carry
p.001197: out this section.
p.001197: (e) USE OF STATE AND AMERICAN INDIAN CONSORTIUM GRANTS.—
p.001197: (1) COMMUNITY SERVICES AND SUPPORTS.—A State or American Indian consortium shall (directly or
p.001197: through awards of contracts to nonprofit private entities) use amounts received under a grant under this section for
p.001197: the following:
p.001197: (A) To develop, change, or enhance community-based service delivery systems that include timely access to com-
p.001197: prehensive appropriate services and supports. Such service and supports—
p.001197: (i) shall promote full participation by individuals with traumatic brain injury and their families in deci- sion
p.001197: making regarding the services and supports; and
p.001197: (ii) shall be designed for children, youth, and adults with traumatic brain injury.
p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
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p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
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p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
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p.001443: candidates shall be selected based on locally delineated and publicized cri- teria. Such criteria shall include a
p.001443: conflict-of-interest standard that is in accordance with paragraph (5).
p.001443: (2) REPRESENTATION.—The HIV health services planning council shall include representatives of—
p.001443: (A) health care providers, including federally qualified health centers;
p.001443: (B) community-based organizations serving affected populations and AIDS service organizations;
p.001443: (C) social service providers, including providers of housing and homeless services;
p.001443: (D) mental health and substance abuse providers;
p.001443: (E) local public health agencies;
p.001443: (F) hospital planning agencies or health care planning agencies;
p.001443: (G) affected communities, including people with HIV/ AIDS, members of a Federally recognized Indian tribe
p.001443: as represented in the population, individuals co-infected with hepatitis B or C and historically underserved
p.001443: groups and subpopulations;
p.001443: (H) nonelected community leaders;
p.001443: (I) State government (including the State medicaid agency and the agency administering the program under
p.001443: part B);
p.001443: (J) grantees under subpart II of part C;
p.001443: (K) grantees under section 2671, or, if none are oper- ating in the area, representatives of
p.001443: organizations with a history of serving children, youth, women, and families liv- ing with HIV and operating in the
p.001443: area;
p.001443: (L) grantees under other Federal HIV programs, in- cluding but not limited to providers of HIV
p.001443: prevention services; and
p.001443: (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released
p.001443: from the custody of the penal system during the preceding 3 years, and had HIV/AIDS as of the date on which the
p.001443: individuals were so released.
p.001443: (3) METHOD OF PROVIDING FOR COUNCIL.—
p.001443: (A) IN GENERAL.—In providing for a council for pur- poses of paragraph (1), a chief elected official
p.001443: receiving a grant under section 2601(a) may establish the council di- rectly or designate an existing entity
p.001443: to serve as the coun- cil, subject to subparagraph (B).
p.001443: (B) CONSIDERATION REGARDING DESIGNATION OF COUN- CIL.—In making a determination of whether to establish or
p.001443: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001445: PUBLIC HEALTH SERVICE ACT
p.001445: Sec. 2602
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p.001453: subparagraph (A) apply. A reduction under the preceding sentence may not be made in an amount that would result
p.001453: in the eli- gible area involved becoming eligible for such an in- crease.
p.001453: (C) LIMITATION.—This paragraph may not be con- strued as having any applicability after fiscal year 2013.
p.001453: (b) SUPPLEMENTAL GRANTS.—
p.001453: (1) IN GENERAL.—Subject to subsection (a)(4)(B)(i) and sec- tion 2610(d), the Secretary shall disburse the
p.001453: remainder of amounts not disbursed under section 2603(a)(2) for such fiscal year for the purpose of making grants
p.001453: under section 2601(a) to eligible areas whose application under section 2605(b)—
p.001453: (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) and the
p.001453: plan for utilization of such funds;
p.001453: (B) demonstrates the need in such area, on an objec- tive and quantified basis, for supplemental financial
p.001453: assist- ance to combat the HIV epidemic;
p.001453: (C) demonstrates the existing commitment of local re- sources of the area, both financial and in-kind, to com-
p.001453: bating the HIV epidemic;
p.001453: (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is
p.001453: im- mediately responsive and cost effective;
p.001453: (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of
p.001453: AIDS including appropriate allocations for services for infants, children, youth, women, and families with
p.001453: HIV/AIDS;
p.001453: (F) demonstrates the inclusiveness of affected commu- nities and individuals with HIV/AIDS;
p.001453: (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment
p.001453: and the statewide coordinated statement of need;
p.001453: (H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most
p.001453: recent grant year under subsection (a) for which data is available, more than 5 percent of grant funds under such
p.001453: subsection canceled, offset under subsection (c)(4), or covered by any waivers under subsection (c)(3); and
p.001453: (I) demonstrates success in identifying individuals with HIV/AIDS as described in clauses (i) through
p.001453: (iii) of paragraph (2)(A).
p.001453: (2) AMOUNT OF GRANT.—
p.001453: (A) IN GENERAL.—The amount of each grant made for purposes of this subsection shall be determined by the Sec-
p.001453: retary based on a weighting of factors under paragraph (1), with demonstrated need under subparagraph (B) of
p.001453: such paragraph counting one-third, and demonstrated success in identifying individuals with HIV/AIDS who do not
p.001453: know their HIV status and making them aware of such status counting one-third. In making such
p.001453: determination, the Secretary shall consider—
p.001453: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001459: of entry specified by
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p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
p.001461: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001461: (f) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001461: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001461: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, the
p.001461: chief elected official of an eligible area, in accordance with the established priorities of the planning
p.001461: council, shall for each of such populations in the eligible area use, from the grants made for the area under
p.001461: sec- tion 2601(a) for a fiscal year, not less than the percentage con- stituted by the ratio of the population
p.001461: involved (infants, chil- dren, youth, or women in such area) with HIV/AIDS to the general population in
p.001461: such area of individuals with HIV/AIDS.
p.001461: (2) WAIVER.—With respect to the population involved, the Secretary may provide to the chief elected official of
p.001461: an eligible area a waiver of the requirement of paragraph (1) if such offi- cial demonstrates to the satisfaction
p.001461: of the Secretary that the population is receiving HIV-related health services through the State medicaid program
p.001461: under title XIX of the Social Security Act, the State children’s health insurance program under title XXI
p.001461: of such Act, or other Federal or State programs.
p.001461: (g) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.001461: (1) PROVISION OF SERVICE.—Subject to paragraph (2), the Secretary may not make a grant under section 2601(a) for
p.001461: the provision of services under this section in a State unless, in the case of any such service that is available
p.001461: pursuant to the State plan approved under title XIX of the Social Security Act for the State—
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p.001461: (A) the political subdivision involved will provide the service directly, and the political subdivision
p.001461: has entered into a participation agreement under the State plan and is qualified to receive payments under such plan;
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p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
p.001473: (1) IN GENERAL.—For the purpose of providing health and support services to infants, children, youth, and
p.001473: women with HIV/AIDS, including treatment measures to prevent the perinatal transmission of HIV, a
p.001473: State shall for each of such populations in the eligible area use, from the grants made for the area
p.001473: under section 2601(a) for a fiscal year, not less than the percentage constituted by the ratio of the
p.001473: population in- volved (infants, children, youth, or women in such area) with HIV/AIDS to the general
p.001473: population in such area of individuals with HIV/AIDS.
p.001473: (2) WAIVER.—With respect to the population involved, the Secretary may provide to a State a waiver of
p.001473: the requirement of paragraph (1) if such State demonstrates to the satisfaction
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001475: 1475
p.001475: PUBLIC HEALTH SERVICE ACT
p.001475: Sec. 2613
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p.001475: January 30, 2020
p.001475: of the Secretary that the population is receiving HIV-related health services through the State medicaid
...

p.001475: shall deliver case management services that link available community support services to appropriate specialized
p.001475: medical services; and
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: 1477
p.001477: PUBLIC HEALTH SERVICE ACT
p.001477: Sec. 2613
p.001477:
p.001477:
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p.001477: January 30, 2020
p.001477: (iv) assurances that the assessment of service needs and the planning of the delivery of services will
p.001477: include participation by individuals with HIV/AIDS;
p.001477: (C) demonstrates that adequate planning has occurred to meet the special needs of families with HIV/AIDS, in-
p.001477: cluding family centered and youth centered care;
p.001477: (D) demonstrates that the consortium has created a mechanism to evaluate periodically—
p.001477: (i) the success of the consortium in responding to identified needs; and
p.001477: (ii) the cost-effectiveness of the mechanisms em- ployed by the consortium to deliver comprehensive care;
p.001477: (E) demonstrates that the consortium will report to the State the results of the evaluations described
p.001477: in sub- paragraph (D) and shall make available to the State or the Secretary, on request, such data and
p.001477: information on the program methodology that may be required to perform an independent evaluation; and
p.001477: (F) demonstrates that adequate planning occurred to address disparities in access and services and
p.001477: historically underserved communities.
p.001477: (2) CONSULTATION.—In establishing the plan required under paragraph (1)(B), the consortium shall consult
p.001477: with—
p.001477: (A)(i) the public health agency that provides or sup- ports ambulatory and outpatient HIV-related health
p.001477: care services within the geographic area to be served; or
p.001477: (ii) in the case of a public health agency that does not directly provide such HIV-related health care services such
p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
p.001517:
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p.001517:
p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
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p.001517:
p.001519: 1519
p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
p.001519: elimination of risk of HIV/AIDS for youth.
p.001519: (2) The applicant will participate in the statewide coordi- nated statement of need under part B (where it has
p.001519: been initi- ated by the public health agency responsible for administering grants under part B) and in revisions of
p.001519: such statement.
p.001519: (3) The applicant will every 2 years submit to the lead State agency under section 2617(b)(4) audits
p.001519: regarding funds expended in accordance with this title and shall include nec- essary client-level data to
p.001519: complete unmet need calculations and Statewide coordinated statements of need process.
p.001519: (d) ADMINISTRATION; APPLICATION.—A grant may only be awarded to an entity under subsection (a) if an
p.001519: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001519: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001519: be nec- essary to carry out this section. Such application shall include the following:
p.001519: (1) Information regarding how the expected expenditures of the grant are related to the planning process
p.001519: for localities funded under part A (including the planning process outlined in section 2602) and for States
p.001519: funded under part B (including the planning process outlined in section 2617(b)).
p.001519: (2) A specification of the expected expenditures and how those expenditures will improve overall patient
p.001519: outcomes, as outlined as part of the State plan (under section 2617(b)) or through additional outcome
p.001519: measures.
p.001519: (e) ANNUAL REVIEW OF PROGRAMS; EVALUATIONS.—
p.001519: (1) REVIEW REGARDING ACCESS TO AND PARTICIPATION IN PROGRAMS.—With respect to a grant under
p.001519: subsection (a) for an entity for a fiscal year, the Secretary shall, not later than 180 days after the
p.001519: end of the fiscal year, provide for the con- duct and completion of a review of the operation during
p.001519: the year of the program carried out under such subsection by the entity. The purpose of such review shall be
p.001519: the development of recommendations, as appropriate, for improvements in the fol- lowing:
p.001519: (A) Procedures used by the entity to allocate opportu- nities and services under subsection (a) among patients
p.001519: of the entity who are women, infants, children, or youth.
p.001519: (B) Other procedures or policies of the entity regarding the participation of such individuals in such program.
p.001519: (2) EVALUATIONS.—— 14The Secretary shall, directly or through contracts with public and private
p.001519: entities, provide for evaluations of programs carried out pursuant to subsection (a).
p.001519: (f) ADMINISTRATIVE EXPENSES.—
p.001519: (1) LIMITATION.—A grantee may not use more than 10 per- cent of amounts received under a grant awarded under
p.001519: this section for administrative expenses.
p.001519:
p.001519:
p.001519:
p.001519: January 30, 2020
p.001519: 14 Dash so in law.
p.001519:
p.001519: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001519:
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p.001519: Sec. 2681 PUBLIC HEALTH SERVICE ACT 1520
p.001519:
p.001519: (2) CLINICAL QUALITY MANAGEMENT PROGRAM.—A grantee under this section shall implement a clinical quality
p.001519: manage- ment program to assess the extent to which HIV health serv- ices provided to patients under the
p.001519: grant are consistent with the most recent Public Health Service guidelines for the treat- ment of HIV/AIDS and
p.001519: related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are
p.001519: consistent with the guidelines for improvement in the ac- cess to and quality of HIV health services.
...

p.001525: of the Office of Management and Budget and revised by the Secretary in accordance with section 673(2) of the Omnibus
p.001525: Budget Rec- onciliation Act of 1981.
p.001525: (10) PERSON.—The term ‘‘person’’ includes one or more in- dividuals, governments (including the Federal Government and
p.001525: the governments of the States), governmental agencies, polit- ical subdivisions, labor unions, partnerships,
p.001525: associations, cor- porations, legal representatives, mutual companies, joint-stock companies, trusts,
p.001525: unincorporated organizations, receivers, trustees, and trustees in cases under title 11, United States
p.001525: Code.
p.001525: (11) STATE.—
p.001525: (A) IN GENERAL.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and each of the
p.001525: terri- tories.
p.001525: (B) TERRITORIES.—The term ‘‘territory’’ means each of American Samoa, Guam, the Commonwealth of Puerto
p.001525: Rico, the Commonwealth of the Northern Mariana Islands,
p.001525: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001525:
p.001525:
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p.001525: Sec. 2691 PUBLIC HEALTH SERVICE ACT 1526
p.001525:
p.001525: the Virgin Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau.
p.001525: (12) YOUTH WITH HIV.—The term ‘‘youth with HIV’’ means individuals who are 13 through 24 years old and who
p.001525: have HIV/AIDS.
p.001525: PART F—DEMONSTRATION AND TRAINING
p.001525: Subpart I—Special Projects of National Significance
p.001525:
p.001525: SEC. 2691. ø300ff–101¿ SPECIAL PROJECTS OF NATIONAL SIGNIFI- CANCE.
p.001525: (a) IN GENERAL.—Of the amount appropriated under each of parts A, B, C, and D for each fiscal year,
p.001525: the Secretary shall use the greater of $20,000,000 or an amount equal to 3 percent of such amount appropriated
p.001525: under each such part, but not to exceed
p.001525: $25,000,000, to administer special projects of national significance to—
p.001525:
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p.001525: January 30, 2020
p.001525: (1) quickly respond to emerging needs of individuals re- ceiving assistance under this title; and
p.001525: (2) to fund special programs to develop a standard elec- tronic client information data system to
p.001525: improve the ability of grantees under this title to report client-level data to the Sec- retary.
p.001525: (b) GRANTS.—The Secretary shall award grants under sub- section (a) to entities eligible for funding under parts
p.001525: A, B, C, and D based on—
p.001525: (1) whether the funding will promote obtaining client level data as it relates to the creation of a severity
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p.001529:
p.001529:
p.001529:
p.001529:
p.001529:
p.001529:
p.001529:
p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
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p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001635: January 30, 2020
p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
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p.000001: the number of appointments authorized by this subsection an appointment shall be deemed to be made in the fiscal
p.000001: year in which the nomination is transmitted by the President to the Senate.
p.000001: (2) In addition to the number of original appointments to the Regular Corps authorized by paragraph (1)
p.000001: to be made to grades above that of senior assistant, original appointments authorized to be made to the Regular
p.000001: Corps in any year may be made to grades above that of senior assistant, but not above that of director, in the case of
p.000001: any individual who—
p.000001: (A)(i) was on active duty in the Regular Corps on July 1, 1960, (ii) was on such active duty
p.000001: continuously for not less than one year immediately prior to such date, and (iii) applies for appointment to the
p.000001: Regular Corps prior to July 1, 1962; or
p.000001: (B) does not come within clause (A)(i) and (ii) but was on active duty in the Reserve Corps continuously for
p.000001: not less than one year immediately prior to his appointment to the Regular Corps and has not served on active
p.000001: duty continuously for a pe- riod, occurring after June 30, 1960, of more than three and one-half years prior
p.000001: to applying for such appointment.
p.000001: (3) No person shall be appointed pursuant to this subsection unless he meets standards established in
p.000001: accordance with regula- tions of the President.
p.000001: (c) Commissions evidencing the appointment by the President of officers of the Regular or Reserve Corps
p.000001: shall be issued by the Secretary under the seal of the Department of Health, Education, and Welfare.
p.000001: (d)(1) For purposes of basic pay and for purposes of promotion, any person appointed under subsection (a) to the
p.000001: grade of senior assistant in the Regular Corps and any person appointed under subsection (b), shall,
p.000001: except as provided in paragraphs (2) and (3) of this subsection, be considered as having had on the
p.000001: date of ap- pointment the following length of service: Three years if appointed to the senior assistant grade,
p.000001: ten years if appointed to the full grade, seventeen years if appointed to the senior grade, and eight- een years
p.000001: if appointed to the director grade.
p.000001: (2) For purposes of basic pay, any person appointed under sub- section (a) to the grade of senior assistant in
p.000001: the Regular Corps, and any person appointed under subsection (b), shall, in lieu of the
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 207 PUBLIC HEALTH SERVICE ACT 10
p.000001:
p.000001: credit provided in paragraph (1), be credited with the service for which he is entitled to credit under
p.000001: any other provision of law if such service exceeds that to which he would be entitled under such paragraph.
p.000001: (3) For purposes of promotion, any person originally appointed in the Regular Corps to the senior assistant
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p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001:
p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
p.000001: full-time employees of the United States shall, while attending meetings or conferences of such council or
p.000001: committee or otherwise engaged on business of such council or committee receive compensation and allowances as
p.000001: pro- vided in section 208(c) for members of national advisory councils established under this Act.
p.000001: (c) Upon appointment of any such council or committee, the Secretary may delegate to such council or committee
p.000001: such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas
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p.000001: involuntarily and without cause to a position in the com- petitive civil service at GS–15 of the
p.000001: General Schedule, and such appointment shall be a career appointment. In the case of such an individual who
p.000001: immediately prior to his appointment to the Service was not a career appointee in the civil service or the Senior
p.000001: Execu- tive Service, such appointment shall be in the excepted civil service and may not exceed a period of 2 years.
p.000001: (f) The Secretary shall promulgate such rules and regulations, not inconsistent with this section, as may be necessary
p.000001: for the effi- cient administration of the Service.
p.000001: SEC. 229. 16 ø237a¿ HEALTH AND HUMAN SERVICES OFFICE ON WOM- EN’S HEALTH.
p.000001: (a) ESTABLISHMENT OF OFFICE.—There is established within the Office of the Secretary, an Office on Women’s
p.000001: Health (referred to in this section as the ‘‘Office’’). The Office shall be headed by a Deputy Assistant
p.000001: Secretary for Women’s Health who may report to the Secretary.
p.000001: (b) DUTIES.—The Secretary, acting through the Office, with re- spect to the health concerns of women, shall—
p.000001: (1) establish short-range and long-range goals and objec- tives within the Department of Health and Human
p.000001: Services and, as relevant and appropriate, coordinate with other appro- priate offices on activities within the
p.000001: Department that relate to disease prevention, health promotion, service delivery, re- search, and public
p.000001: and health care professional education, for issues of particular concern to women throughout their life-
p.000001: span;
p.000001: (2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues
p.000001: relating to women’s health;
p.000001: (3) monitor the Department of Health and Human Serv- ices’ offices, agencies, and regional activities
p.000001: regarding wom- en’s health and identify needs regarding the coordination of ac- tivities, including intramural and
p.000001: extramural multidisciplinary activities;
p.000001: (4) establish a Department of Health and Human Services Coordinating Committee on Women’s Health, which shall be
p.000001: chaired by the Deputy Assistant Secretary for Women’s Health and composed of senior level representatives from
p.000001: each of the agencies and offices of the Department of Health and Human Services;
p.000001: (5) establish a National Women’s Health Information Cen- ter to—
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: 16 Section 3509 of the Patient Protection and Affordable Care Act (Public Law 111–148, en- acted March 23,
p.000001: 2010) established offices of womens health in the Office of the Secretary of HHS (this section), the Centers for
p.000001: Disease Control and Prevention (section 310A of this Act), the Agency for Healthcare Research and Quality
p.000001: (section 925 of this Act), the Health Resources and Services Administration (section 713 of the Social Security Act),
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p.000017: January 30, 2020
p.000017: (A) 150 medical students annually, 10 of whom shall be awarded studentships to the Uniformed Services
p.000017: Uni- versity of Health Sciences;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 272 PUBLIC HEALTH SERVICE ACT 68
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p.000017: January 30, 2020
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p.000017: (B) 100 dental students annually;
p.000017: (C) 250 nursing students annually;
p.000017: (D) 100 public health students annually;
p.000017: (E) 100 behavioral and mental health professional stu- dents annually;
p.000017: (F) 100 physician assistant or nurse practitioner stu- dents annually; and
p.000017: (G) 50 pharmacy students annually.
p.000017: (2) LOCATIONS.—The Track shall be located at existing and accredited, affiliated health professions education training
p.000017: pro- grams at academic health centers located in regions of the United States determined appropriate by the
p.000017: Surgeon General, in consultation with the National Health Care Workforce Com- mission established in section 5101
p.000017: of the Patient Protection and Affordable Care Act.
p.000017: (b) NUMBER OF GRADUATES.—Except as provided in subsection (a), the number of persons to be graduated from the Track
p.000017: shall be prescribed by the Secretary. In so prescribing the number of per- sons to be graduated from the
p.000017: Track, the Secretary shall institute actions necessary to ensure the maximum number of first-year en- rollments in
p.000017: the Track consistent with the academic capacity of the affiliated sites and the needs of the United States for medical,
p.000017: den- tal, and nursing personnel.
p.000017: (c) DEVELOPMENT.—The development of the Track may be by such phases as the Secretary may prescribe subject to
p.000017: the require- ments of subsection (a).
p.000017: (d) INTEGRATED LONGITUDINAL PLAN.—The Surgeon General shall develop an integrated longitudinal plan for health
p.000017: professions continuing education throughout the continuum of health-related education, training, and practice.
p.000017: Training under such plan shall emphasize patient-centered, interdisciplinary, and care coordina- tion
p.000017: skills. Experience with deployment of emergency response teams shall be included during the clinical experiences.
p.000017: (e) FACULTY DEVELOPMENT.—The Surgeon General shall de- velop faculty development programs and curricula in
p.000017: decentralized venues of health care, to balance urban, tertiary, and inpatient venues.
p.000017: SEC. 272. ø239l–1¿ ADMINISTRATION.
p.000017: (a) IN GENERAL.—The business of the Track shall be conducted by the Surgeon General with funds appropriated for
p.000017: and provided by the Department of Health and Human Services. The National Health Care Workforce Commission
p.000017: shall assist the Surgeon Gen- eral in an advisory capacity.
p.000017: (b) FACULTY.—
p.000017: (1) IN GENERAL.—The Surgeon General, after considering the recommendations of the National Health Care
p.000017: Workforce Commission, shall obtain the services of such professors, in- structors, and administrative and
p.000017: other employees as may be necessary to operate the Track, but utilize when possible, ex- isting
p.000017: affiliated health professions training institutions. Mem- bers of the faculty and staff shall be employed
p.000017: under salary schedules and granted retirement and other related benefits prescribed by the Secretary so as to
p.000017: place the employees of the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: other related benefits.
p.000017: (c) AGREEMENTS.—The Surgeon General may negotiate agree- ments with agencies of the Federal Government to utilize
p.000017: on a re- imbursable basis appropriate existing Federal medical resources lo- cated in the United States (or locations
p.000017: selected in accordance with section 271(a)(2)). Under such agreements the facilities concerned will retain
p.000017: their identities and basic missions. The Surgeon Gen- eral may negotiate affiliation agreements with
p.000017: accredited univer- sities and health professions training institutions in the United States. Such agreements
p.000017: may include provisions for payments for educational services provided students participating in Department of
p.000017: Health and Human Services educational programs.
p.000017: (d) PROGRAMS.—The Surgeon General may establish the fol- lowing educational programs for Track students:
p.000017: (1) Postdoctoral, postgraduate, and technological programs.
p.000017: (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students.
p.000017: (3) Other programs that the Surgeon General determines necessary in order to operate the Track in a
p.000017: cost-effective man- ner.
p.000017: (e) CONTINUING MEDICAL EDUCATION.—The Surgeon General shall establish programs in continuing medical education
p.000017: for mem- bers of the health professions to the end that high standards of health care may be maintained
p.000017: within the United States.
p.000017: (f) AUTHORITY OF THE SURGEON GENERAL.—
p.000017: (1) IN GENERAL.—The Surgeon General is authorized—
p.000017: (A) to enter into contracts with, accept grants from, and make grants to any nonprofit entity for the purpose
p.000017: of carrying out cooperative enterprises in medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, public health, and nursing research, consultation, and education;
p.000017: (B) to enter into contracts with entities under which the Surgeon General may furnish the services of such pro-
p.000017: fessional, technical, or clerical personnel as may be nec- essary to fulfill cooperative enterprises
p.000017: undertaken by the Track;
p.000017: (C) to accept, hold, administer, invest, and spend any gift, devise, or bequest of personal property
p.000017: made to the Track, including any gift, devise, or bequest for the sup- port of an academic chair,
p.000017: teaching, research, or dem- onstration project;
p.000017: (D) to enter into agreements with entities that may be utilized by the Track for the purpose of enhancing the ac-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 273 PUBLIC HEALTH SERVICE ACT 70
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p.000017: January 30, 2020
p.000017:
p.000017: tivities of the Track in education, research, and techno- logical applications of knowledge; and
p.000017: (E) to accept the voluntary services of guest scholars and other persons.
p.000017: (2) LIMITATION.—The Surgeon General may not enter into any contract with an entity if the contract would
p.000017: obligate the Track to make outlays in advance of the enactment of budget authority for such outlays.
p.000017: (3) SCIENTISTS.—Scientists or other medical, dental, or nursing personnel utilized by the Track under
p.000017: an agreement described in paragraph (1) may be appointed to any position within the Track and may be
p.000017: permitted to perform such duties within the Track as the Surgeon General may approve.
p.000017: (4) VOLUNTEER SERVICES.—A person who provides vol- untary services under the authority of
p.000017: subparagraph (E) of paragraph (1) shall be considered to be an employee of the Fed- eral Government for the purposes
p.000017: of chapter 81 of title 5, relat- ing to compensation for work-related injuries, and to be an em- ployee of the
p.000017: Federal Government for the purposes of chapter 171 of title 28, relating to tort claims. Such a person
p.000017: who is not otherwise employed by the Federal Government shall not be considered to be a Federal employee
p.000017: for any other purpose by reason of the provision of such services.
p.000017: SEC. 273. ø239l–2¿ STUDENTS; SELECTION; OBLIGATION.
p.000017: (a) STUDENT SELECTION.—
p.000017: (1) IN GENERAL.—Medical, dental, physician assistant, pharmacy, behavioral and mental health, public
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p.000017: officials and sci- entists engaged in special study;
p.000017: (3) make grants-in-aid to universities, hospitals, labora- tories, and other public or private
p.000017: institutions, and to individ- uals for such research projects as are recommended by the ad- visory council to the
p.000017: entity of the Department supporting such projects and make, upon recommendation of the advisory coun- cil to the
p.000017: appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals,
p.000017: laboratories, and other institutions for the general support of their research;
p.000017: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000017: experts, scholars, and consultants from the United States or abroad;
p.000017: (5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons
p.000017: not otherwise el- igible for such treatment;
p.000017: (6) make available, to health officials, scientists, and ap- propriate public and other nonprofit institutions
p.000017: and organiza- tions, technical advice and assistance on the application of sta- tistical methods to experiments,
p.000017: studies, and surveys in health and medical fields;
p.000017: (7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law
p.000017: applicable to contracts entered into by the military departments under title 10, United States Code,
p.000017: sections 2353 and 2354, except that determination, approval, and certification required there- by shall be by
p.000017: the Secretary of Health, Education, and Welfare; and
p.000017:
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p.000017: January 30, 2020
p.000017: (8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department
p.000017: or, with respect to mental health, the National Advisory Mental Health Coun- cil, such additional means as
p.000017: the Secretary considers necessary or appropriate to carry out the purposes of this section.
p.000017: (b)(1) The Secretary shall conduct and may support through grants and contracts studies and testing of
p.000017: substances for carcino-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 301 PUBLIC HEALTH SERVICE ACT 74
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p.000017: genicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the
p.000017: Secretary shall consult with entities of the Federal Government, outside of the Department of Health, Education, and
p.000017: Welfare, engaged in comparable activi- ties. The Secretary, upon request of such an entity and under
p.000017: ap- propriate arrangements for the payment of expenses, may conduct for such entity studies and testing of
p.000017: substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
p.000017: (2)(A) The Secretary shall establish a comprehensive program of research into the biological effects of
p.000017: low-level ionizing radiation under which program the Secretary shall conduct such research and may support such
p.000017: research by others through grants and con- tracts.
p.000017: (B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological
p.000017: effects of ionizing radiation.
p.000017: (3) The Secretary shall conduct and may support through grants and contracts research and studies on
p.000017: human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and
p.000017: on the maintenance and promotion of health, and programs for the dissemination of information re- specting
p.000017: human nutrition to health professionals and the public. In carrying out activities under this paragraph, the
p.000017: Secretary shall provide for the coordination of such of these activities as are per- formed by the
p.000017: different divisions within the Department of Health, Education, and Welfare and shall consult with entities of the Fed-
p.000017: eral Government, outside of the Department of Health, Education, and Welfare, engaged in comparable activities. The
p.000017: Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses,
p.000017: may conduct and support such activities for such entity.
p.000017: (4) The Secretary shall publish a biennial report which con- tains—
p.000017: (A) a list of all substances (i) which either are known to
p.000017: be carcinogens or may reasonably be anticipated to be carcino- gens and (ii) to which a significant number of persons
p.000017: residing in the United States are exposed;
p.000017: (B) information concerning the nature of such exposure and the estimated number of persons exposed to
p.000017: such sub- stances;
p.000017: (C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent,
p.000017: ambient, or exposure standard has been established by a Federal agen- cy, and (ii) for each effluent, ambient,
p.000017: or exposure standard es- tablished by a Federal agency with respect to a substance con- tained in the list under
p.000017: subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard,
p.000017: and the implementation of such standard by the agency, decreases the risk to public health from exposure
p.000017: to the substance; and
p.000017: (D) a description of (i) each request received during the year involved—
p.000017:
p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
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p.000017: 75 PUBLIC HEALTH SERVICE ACT Sec. 301
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p.000017: January 30, 2020
p.000017: (I) from a Federal agency outside the Department of Health, Education, and Welfare for the Secretary, or
p.000017: (II) from an entity within the Department of Health, Education, and Welfare to any other entity within the De-
p.000017: partment,
p.000017: to conduct research into, or testing for, the carcinogenicity of substances or to provide information
p.000017: described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity,
p.000017: respectively, have responded to each such request.
p.000017: (5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research,
p.000017: or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or
p.000017: in such amounts as are provided in ad- vance in Appropriation Acts.
p.000017: (c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the
p.000017: identification, control, treat- ment, and prevention of diseases (including tropical diseases) which do
p.000017: not occur to a significant extent in the United States.
p.000017: (d)(1)(A) If a person is engaged in biomedical, behavioral, clin- ical, or other research, in which identifiable,
p.000017: sensitive information is collected (including research on mental health and research on the use and effect
p.000017: of alcohol and other psychoactive drugs), the Sec- retary, in coordination with other agencies, as applicable—
p.000017: (i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are
p.000017: the subjects of such research if the research is funded wholly or in part by the Federal Government; and
...

p.000017: renovate facilities in those countries.
p.000017: (c) The Secretary may provide to personnel appointed or as- signed by the Secretary to serve abroad,
p.000017: allowances and benefits similar to those provided under chapter 9 of title I of the Foreign Service Act
p.000017: of 1980 (22 U.S.C. 4081 et seq.). Leaves of absence for personnel under this subsection shall be on the same basis as
p.000017: that provided under subchapter I of chapter 63 of title 5, United States Code or section 903 of the Foreign
p.000017: Service Act of 1980 (22 U.S.C. 4083), to individuals serving in the Foreign Service.
p.000017: (d) In carrying out immunization programs and other programs in developing countries for the prevention,
p.000017: treatment, and control of infectious diseases, including HIV/AIDS, tuberculosis, and ma- laria, the Director
p.000017: of the Centers for Disease Control and Preven- tion, in coordination with the Coordinator of United States
p.000017: Govern- ment Activities to Combat HIV/AIDS Globally, the National Insti- tutes of Health, national and local
p.000017: government, and other organiza- tions, such as the World Health Organization and the United Na- tions
p.000017: Children’s Fund, shall develop and implement effective strat- egies to improve injection safety, including eliminating
p.000017: unnecessary injections, promoting sterile injection practices and technologies, strengthening the procedures
p.000017: for proper needle and syringe dis- posal, and improving the education and information provided to the public and
p.000017: to health professionals.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 87 PUBLIC HEALTH SERVICE ACT Sec. 308
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p.000017: January 30, 2020
p.000017: GENERAL PROVISIONS RESPECTING EFFECTIVENESS, EFFICIENCY, AND QUALITY OF HEALTH SERVICES
p.000017: SEC. 308. ø242m¿ (a)(1) Not later than March 15 of each year, the Secretary shall submit to the President and
p.000017: Congress the fol- lowing reports:
p.000017: (A) A report on health care costs and financing. Such re- port shall include a description and analysis
p.000017: of the statistics collected under section 306(b)(1)(G).
p.000017: (B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the
p.000017: statis- tics collected under section 306(b)(1)(E).
...

p.000017: person has consented (as determined under regulations of the Secretary) to its publication or release in other form.
p.000017: (e)(1) Payments of any grant or under any contract under sec- tion 304, 306, or 307 may be made in advance or
p.000017: by way of reim- bursement, and in such installments and on such conditions, as the Secretary deems necessary to
p.000017: carry out the purposes of such sec- tion.
p.000017: (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307
p.000017: shall be re- duced by—
p.000017: (A) amounts equal to the fair market value of any equip- ment or supplies furnished to such person by the
p.000017: Secretary for the purpose of carrying out the project with respect to which such grant or contract is made,
p.000017: and
p.000017: (B) amounts equal to the pay, allowances, traveling ex- penses, and related personnel expenses attributable to
p.000017: the per- formance of services by an officer or employee of the Govern- ment in connection with such
p.000017: project, if such officer or em- ployee was assigned or detailed by the Secretary to perform such
p.000017: services,
p.000017: but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as
p.000017: the case may be.
p.000017: (f) Contracts may be entered into under section 304 or 306 without regard to section 3324 of title 31, United
p.000017: States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5).
p.000017: HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION
p.000017: SEC. 310. 5 ø242o¿ (a) A conference of the health authorities in and among the several States shall be called
p.000017: annually by the Sec- retary. Whenever in his opinion the interests of the public health
p.000017:
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p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 5 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat. 2205).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 89 PUBLIC HEALTH SERVICE ACT Sec. 310A
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p.000017: January 30, 2020
p.000017: would be promoted by a conference, the Secretary may invite as many of such health authorities and officials
p.000017: of other State or local public or private agencies, institutions, or organizations to confer as he deems
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p.000017: to mental health are to be discussed, the mental health au- thorities of the respective States shall be invited to
p.000017: attend.
p.000017: (b) From time to time the Secretary shall issue information re- lated to public health, in the form of publications or
p.000017: otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United
p.000017: States and other countries and other perti- nent health information for the use of persons and institutions con- cerned
p.000017: with health services.
p.000017: SEC. 310A. ø242s¿ CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN’S HEALTH.
p.000017: (a) ESTABLISHMENT.—There is established within the Office of the Director of the Centers for Disease Control and
p.000017: Prevention, an office to be known as the Office of Women’s Health (referred to in this section as the
p.000017: ‘‘Office’’). The Office shall be headed by a direc- tor who shall be appointed by the Director of such Centers.
p.000017: (b) PURPOSE.—The Director of the Office shall—
p.000017: (1) report to the Director of the Centers for Disease Con- trol and Prevention on the current level of the
p.000017: Centers’ activity regarding women’s health conditions across, where appro- priate, age, biological, and
p.000017: sociocultural contexts, in all aspects of the Centers’ work, including prevention programs, public and
p.000017: professional education, services, and treatment;
p.000017: (2) establish short-range and long-range goals and objec- tives within the Centers for women’s health
p.000017: and, as relevant and appropriate, coordinate with other appropriate offices on activities within the
p.000017: Centers that relate to prevention, re- search, education and training, service delivery, and policy de- velopment,
p.000017: for issues of particular concern to women;
p.000017: (3) identify projects in women’s health that should be con- ducted or supported by the Centers;
p.000017: (4) consult with health professionals, nongovernmental or- ganizations, consumer organizations, women’s health
p.000017: profes- sionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to
p.000017: women; and
p.000017: (5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s
p.000017: Health (established under section 229(b)(4)).
p.000017: (c) DEFINITION.—As used in this section, the term ‘‘women’s health conditions’’, with respect to women of all
p.000017: age, ethnic, and ra- cial groups, means diseases, disorders, and conditions—
p.000017: (1) unique to, significantly more serious for, or signifi- cantly more prevalent in women; and
p.000017: (2) for which the factors of medical risk or type of medical intervention are different for women, or for which there
...

p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
p.000017:
p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
p.000017: (7) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (d) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a State, political subdivision
p.000017: of a State, Indian tribe, or tribal organization shall prepare and submit an appli- cation to the Secretary at such
p.000017: time, in such manner, and con- taining such information as the Secretary may reasonably re- quire.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) shall—
p.000017: (A) describe the comprehensive public access defibrillation program to be funded with the
p.000017: grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to
p.000017: cardiac ar- rest victims in the community;
p.000017: (B) contain procedures for implementing appropriate nationally recognized training courses in
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p.000017: medical program or programs included in whole or in part within the State) and of consumers of health
p.000017: services, to advise such State agency in carrying out its func- tions under the plan, and a majority of the
p.000017: membership of such council shall consist of representatives of consumers of health services;
p.000017: (C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the
p.000017: Secretary, are designed to provide for comprehensive State planning for health services (both public and
p.000017: private and including home health care), including the facilities and persons required for the provision of
p.000017: such services, to meet the health needs of the people of the State and including environmental considerations as they
p.000017: relate to public health;
p.000017: (D) provide for encouraging cooperative efforts among gov- ernmental or nongovernmental agencies, organizations
p.000017: and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such
p.000017: agencies, organiza-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 95 PUBLIC HEALTH SERVICE ACT Sec. 314
p.000017:
p.000017: tions, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and
p.000017: rehabilitation;
p.000017: (E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this
p.000017: subsection will be used to supplement and, to the extent practicable, to increase the level of funds that
p.000017: would otherwise be made available by the State for the purpose of comprehensive health planning and not to
p.000017: supplant such non-Federal funds;
p.000017: (F) 7 provide such methods of administration (including methods relating to the establishment and maintenance
p.000017: of per- sonnel standards on a merit basis, except that the Secretary shall exercise no authority with respect
p.000017: to the selection, tenure of office, and compensation of any individual employed in ac- cordance with such
p.000017: methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
p.000017: (G) provide that the State agency will make such reports, in such form and containing such information, as the
p.000017: Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as
p.000017: the Secretary finds necessary to assure the correctness and verification of such re- ports;
p.000017: (H) provide that the State agency will from time to time, but not less often than annually, review its
p.000017: State plan ap- proved under this subsection and submit to the Secretary ap- propriate modifications
p.000017: thereof;
p.000017: (I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop
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p.000017: consisting of awarding demonstration grants to States to streamline State requirements and procedures in
p.000017: order to assist veterans who held certain military occupational specialties related to medical care or who have
p.000017: completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification,
p.000017: licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni-
p.000017: cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician
p.000017: assistant professions) in the State.
p.000017: (2) CONSULTATION AND COLLABORATION.—In determining the eligible military occupational specialties or training
p.000017: courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of
p.000017: Defense, the Sec- retary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’
p.000017: Employment and Training, and shall col- laborate with the initiatives carried out under section 4114 of
p.000017: title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code.
p.000017: (b) USE OF FUNDS.—Amounts received as a demonstration grant under this section shall be used to—
p.000017: (1) prepare and implement a plan to streamline State re- quirements and procedures as described in
p.000017: subsection (a), in- cluding by—
p.000017: (A) determining the extent to which the requirements for the education, training, and skill level of civilian
p.000017: health care professions (such as emergency medical technicians, paramedics, licensed practical nurses,
p.000017: registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to
p.000017: requirements for the education, training, and skill level of veterans who served in medical
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 99 PUBLIC HEALTH SERVICE ACT Sec. 317
p.000017:
p.000017: related fields while a member of the Armed Forces of the United States; and
p.000017: (B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed
p.000017: Forces of the United States to forgo or meet any such equivalent State requirements; and
p.000017: (2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to
p.000017: meet certification, licensure or other requirements applicable to becoming a civil- ian health care professional
p.000017: (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse,
p.000017: physical therapy assistant, or physician assistant pro- fessions) in the State, develop or expand career pathways
p.000017: at in- stitutions of higher education to support veterans in meeting such requirements.
p.000017: (c) REPORT.—Upon the completion of the demonstration pro- gram under this section, the Secretary shall
p.000017: submit to Congress a report on the program.
p.000017: (d) FUNDING.—No additional funds are authorized to be appro- priated for the purpose of carrying out this
p.000017: section. This section shall be carried out using amounts otherwise available for such purpose.
p.000017: (e) SUNSET.—The demonstration program under this section shall not exceed 5 years.
p.000017: FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
p.000017: SEC. 316. 8 ø247a¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute
p.000017: of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the
p.000017: establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to
p.000017: assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of
p.000017: such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
p.000017: (1) university medical centers and other appropriate health care facilities which receive Federal funds from the
p.000017: Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such
p.000017: disease; and
p.000017: (2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
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p.000101: entities in connection with the operation of their preventive health service programs.
p.000101: (j)(1) Except for grants for immunization programs the author- ization of appropriations for which are
p.000101: established in paragraph (2), for grants under subsections (a) and (k)(1) for preventive health service programs to
p.000101: immunize without charge children, adolescents, and adults against vaccine-preventable diseases, there are
p.000101: author- ized to be appropriated such sums as may be necessary. Not more than 10 percent ot the total amount
p.000101: appropriated under the pre- ceding sentence for any fiscal year shall be available for grants under
p.000101: subsection (k)(1) for such fiscal year.
p.000101: (2) For grants under subsection (a) for preventive health serv- ice programs for the provision without charge of
p.000101: immunizations with vaccines approved for use, and recommended for routine use, there are authorized to be
p.000101: appropriated such sums as may be nec- essary.
p.000101: (k)(1) The Secretary may make grants to States, political sub- divisions of States, and other public and
p.000101: nonprofit private entities for—
p.000101:
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p.000101: (A) research into the prevention and control of diseases that may be prevented through vaccination;
p.000101: (B) demonstration projects for the prevention and control of such diseases;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000101: diseases for health professionals (including allied health personnel).
p.000101: (2) The Secretary may make grants to States, political subdivi- sions of States, and other public and nonprofit private
p.000101: entities for—
p.000101: (A) research into the prevention and control of diseases and conditions;
p.000101: (B) demonstration projects for the prevention and control of such diseases and conditions;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases and conditions; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases
p.000101: and con-
p.000101: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000103: PUBLIC HEALTH SERVICE ACT
p.000103: Sec. 317
p.000103:
p.000103: ditions for health professionals (including allied health per- sonnel).
p.000103: (3) No grant may be made under this subsection unless an ap- plication therefor is submitted to the Secretary in
p.000103: such form, at such time, and containing such information as the Secretary may by regulation prescribe.
p.000103: (4) Subsections (d), (e), and (f) shall apply to grants under this subsection in the same manner as such subsections
p.000103: apply to grants under subsection (a).
p.000103: (l) AUTHORITY TO PURCHASE RECOMMENDED VACCINES FOR
p.000103: ADULTS.—
p.000103: (1) IN GENERAL.—The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the
p.000103: purchase and delivery of vaccines for adults as provided for under sub- section (e).
p.000103: (2) STATE PURCHASE.—A State may obtain additional quan- tities of such adult vaccines (subject to amounts
p.000103: specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from
p.000103: manufacturers at the applicable price negotiated by the Secretary under this subsection.
p.000103: (m) DEMONSTRATION PROGRAM TO IMPROVE IMMUNIZATION COVERAGE.—
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p.000103: interventions, including—
p.000103: (A) providing immunization reminders or recalls for target populations of clients, patients, and consumers;
p.000103: (B) educating targeted populations and health care providers concerning immunizations in combination with
p.000103: one or more other interventions;
p.000103: (C) reducing out-of-pocket costs for families for vac- cines and their administration;
p.000103: (D) carrying out immunization-promoting strategies for participants or clients of public programs, including
p.000103: as- sessments of immunization status, referrals to health care
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000103: providers, education, provision of on-site immunizations, or incentives for immunization;
p.000103: (E) providing for home visits that promote immuniza- tion through education, assessments of need, referrals,
p.000103: pro- vision of immunizations, or other services;
p.000103: (F) providing reminders or recalls for immunization providers;
p.000103: (G) conducting assessments of, and providing feedback to, immunization providers;
p.000103: (H) any combination of one or more interventions de- scribed in this paragraph; or
p.000103: (I) immunization information systems to allow all States to have electronic databases for
p.000103: immunization records.
p.000103: (4) CONSIDERATION.—In awarding grants under this sub- section, the Secretary shall consider any
p.000103: reviews or rec- ommendations of the Task Force on Community Preventive Services.
p.000103: (5) EVALUATION.—Not later than 3 years after the date on which a State receives a grant under this subsection, the
p.000103: State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage
p.000103: rates among high- risk populations within the State.
p.000103: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Affordable Health Choices
p.000103: Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program
p.000103: established under this subsection together with recommendations on whether to continue and expand such program.
p.000103: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection, such
p.000103: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000103: SCREENINGS, REFERRALS, AND EDUCATION REGARDING LEAD POISONING
p.000103: SEC. 317A. ø247b–1¿ (a) AUTHORITY FOR GRANTS.—
p.000103: (1) IN GENERAL.—Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease
p.000103: Control and Prevention, may make grants to States and political sub- divisions of States for the
p.000103: initiation and expansion of commu- nity programs designed—
p.000103: (A) to provide, for infants and children—
p.000103: (i) screening for elevated blood lead levels;
p.000103: (ii) referral for treatment of such levels; and
p.000103: (iii) referral for environmental intervention associ- ated with such levels; and
p.000103: (B) to provide education about childhood lead poi- soning.
p.000103: (2) AUTHORITY REGARDING CERTAIN ENTITIES.—With re- spect to a geographic area with a need for activities
p.000103: authorized in paragraph (1), in any case in which neither the State nor the political subdivision in
p.000103: which such area is located has ap- plied for a grant under paragraph (1), the Secretary may make
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: PUBLIC HEALTH SERVICE ACT
p.000105: Sec. 317A
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p.000105: a grant under such paragraph to any grantee under section 329, 330, or 340A for carrying out such
p.000105: activities in the area.
p.000105: (3) PROVISION OF ALL SERVICES AND ACTIVITIES THROUGH EACH GRANTEE.—In making grants under paragraph (1),
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p.000107: (D) A description of the severity of the extent of the blood lead levels of the infants and children
p.000107: screened, ex- pressed in categories of severity.
p.000107: (E) The sources of payment for the screenings.
p.000107: (F) The number of grantees that have established sys- tems to ensure mandatory reporting of all blood lead tests from
p.000107: laboratories and health care providers to State and local health departments.
p.000107: (G) A comparison of the data provided pursuant to subparagraphs (A) through (F) with the equivalent data, if
p.000107: any, provided in the report under paragraph (1) preceding the report involved.
p.000107: (k) INDIAN TRIBES.—For purposes of this section, the term ‘‘po- litical subdivision’’ includes Indian tribes.
p.000107: (l) FUNDING.—
p.000107: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000107: be appro- priated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years
p.000107: 1994 through 2005.
p.000107: (2) ALLOCATION FOR OTHER PROGRAMS.—Of the amounts appropriated under paragraph (1) for any fiscal year,
p.000107: the Sec- retary may reserve not more than 20 percent for carrying out programs regarding the activities
p.000107: described in subsection (a) in addition to the program of grants established in such sub- section.
p.000107: (m) GUIDELINES FOR STANDARDIZED REPORTING.—The Sec- retary, acting through the Director of the Centers for
p.000107: Disease Con- trol and Prevention, shall develop national guidelines for the uni- form reporting of all
p.000107: blood lead test results to State and local health departments.
p.000107: EDUCATION, TECHNOLOGY ASSESSMENT, AND EPIDEMIOLOGY REGARDING LEAD POISONING
p.000107: SEC. 317B. ø247b–3¿ (a) PREVENTION.—
p.000107: (1) PUBLIC EDUCATION.—The Secretary, acting through the Director of the Centers for Disease Control and
p.000107: Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general
p.000107: public on the prevention of lead poisoning in infants and children. In carrying out the pro- gram, the Secretary
p.000107: shall make available information con-
p.000107: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000109: PUBLIC HEALTH SERVICE ACT
p.000109: Sec. 317B
p.000109:
p.000109: cerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and
p.000109: secondary preventive measures that may be taken to prevent such poisoning.
p.000109: (2) INTERAGENCY TASK FORCE.—
p.000109: (A) Not later than 6 months after the date of the en- actment of the Preventive Health Amendments of
p.000109: 1992 9, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of
p.000109: Lead Poi- soning (in this paragraph referred to as the ‘‘Task Force’’). The Task Force shall coordinate the
p.000109: efforts of Federal agencies to prevent lead poisoning.
p.000109: (B) The Task Force shall be composed of—
p.000109: (i) the Secretary, who shall serve as the chair of the Task Force;
p.000109: (ii) the Secretary of Housing and Urban Develop- ment;
p.000109: (iii) the Administrator of the Environmental Pro- tection Agency; and
p.000109: (iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials re-
p.000109: spectively.
p.000109: (C) The Task Force shall—
p.000109: (i) review, evaluate, and coordinate current strate- gies and plans formulated by the officials serving as
p.000109: members of the Task Force, including—
p.000109: (I) the plan of the Secretary of Health and Human Services entitled ‘‘Strategic Plan for the Elimination
p.000109: of Lead Poisoning’’, dated February 21, 1991;
p.000109: (II) the plan of the Secretary of Housing and Urban Development entitled ‘‘Comprehensive and Workable Plan
p.000109: for the Abatement of Lead-Based Paint in Privately Owned Housing’’, dated Decem- ber 7, 1990; and
p.000109: (III) the strategy of the Administrator of the Environmental Protection Agency entitled ‘‘Strat- egy for
p.000109: Reducing Lead Exposures’’, dated Feb- ruary 21, 1991;
p.000109: (ii) develop a unified implementation plan for pro- grams that receive Federal financial assistance for ac- tivities
p.000109: related to the prevention of lead poisoning;
p.000109: (iii) establish a mechanism for sharing and dis- seminating information among the agencies rep-
p.000109: resented on the Task Force;
p.000109: (iv) identify the most promising areas of research and education concerning lead poisoning;
p.000109: (v) identify the practical and technological con- straints to expanding lead poisoning prevention;
p.000109: (vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and
p.000109: not later than May 1 of each year, sub- mit to the Committee on Labor and Human Resources
p.000109:
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p.000109: January 30, 2020
p.000109: 9 Enacted October 27, 1992.
p.000109:
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000109: Sec. 317C PUBLIC HEALTH SERVICE ACT 110
p.000109: of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and
p.000109: Commerce of the House of Representa- tives, a report that summarizes the findings made as a result of such
p.000109: review and that contains the rec- ommendations of the Task Force on the programs and policies with respect to
p.000109: which the Task Force is estab- lished, including related budgetary recommendations; and
p.000109: (vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning
p.000109: prevention activities of the Federal Govern- ment.
p.000109: (b) TECHNOLOGY ASSESSMENT AND EPIDEMIOLOGY.—The Sec- retary, acting through the Director of the Centers for
p.000109: Disease Con- trol and Prevention, shall, directly or through grants or contracts—
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p.000109: NATIONAL CENTER ON BIRTH DEFECTS AND DEVELOPMENTAL DISABILITIES
p.000109: SEC. 317C. ø247b–4¿ (a) IN GENERAL.—
p.000109: (1) NATIONAL CENTER.—There is established within the Centers for Disease Control and Prevention a center
p.000109: to be known as the National Center on Birth Defects and Develop- mental Disabilities (referred to in this
p.000109: section as the ‘‘Center’’), which shall be headed by a director appointed by the Director of the Centers for Disease
p.000109: Control and Prevention.
p.000109: (2) GENERAL DUTIES.—The Secretary shall carry out pro- grams—
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p.000109: (A) to collect, analyze, and make available data on birth defects, developmental disabilities, and
p.000109: disabilities and health (in a manner that facilitates compliance with subsection (c)(2)), including data on the
p.000109: causes of such de- fects and disabilities and on the incidence and prevalence of such defects and disabilities;
p.000109: (B) to operate regional centers for the conduct of ap- plied epidemiological research on the prevention
p.000109: of such defects and disabilities;
p.000109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000111: PUBLIC HEALTH SERVICE ACT
p.000111: Sec. 317C
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p.000111: (C) to provide information and education to the public on the prevention of such defects and disabilities;
p.000111: (D) to conduct research on and to promote the preven- tion of such defects and disabilities, and secondary
p.000111: health conditions among individuals with disabilities; and
p.000111: (E) to support a National Spina Bifida Program to pre- vent and reduce suffering from the Nation’s most common
p.000111: permanently disabling birth defect.
p.000111: (3) FOLIC ACID.—The Secretary shall carry out section 317J through the Center.
p.000111: (4) CERTAIN PROGRAMS.—
p.000111: (A) TRANSFERS.—All programs and functions described in subparagraph (B) are transferred to the Center, effec-
p.000111: tive upon the expiration of the 180-day period beginning on the date of the enactment of the Children’s Health
p.000111: Act of 2000 10.
p.000111: (B) RELEVANT PROGRAMS.—The programs and func- tions described in this subparagraph are all programs and functions
p.000111: that—
p.000111: (i) relate to birth defects; folic acid; cerebral palsy; intellectual disabilities; child development; newborn
p.000111: screening; autism; fragile X syndrome; fetal alcohol syndrome; pediatric genetic disorders; disability pre-
p.000111: vention; or other relevant diseases, disorders, or condi- tions as determined the Secretary; and
p.000111: (ii) were carried out through the National Center for Environmental Health as of the day before the date
p.000111: of the enactment of the Act referred to in sub- paragraph (A).
p.000111: (C) RELATED TRANSFERS.—Personnel employed in con- nection with the programs and functions specified in
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p.000113: to be appropriated such sums as may be necessary for each of fiscal years 2003 through 2007.
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p.000113: PREVENTIVE HEALTH MEASURES WITH RESPECT TO PROSTATE CANCER
p.000113: SEC. 317D. ø247b–5¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000113: Control and Pre- vention, may make grants to States and local health departments for the purpose of
p.000113: enabling such States and departments to carry out programs that may include the following:
p.000113: (1) To identify factors that influence the attitudes or levels of awareness of men and health care practitioners
p.000113: regarding screening for prostate cancer.
p.000113: (2) To evaluate, in consultation with the Agency for Health Care Policy and Research and the National
p.000113: Institutes of Health, the effectiveness of screening strategies for prostate cancer.
p.000113: (3) To identify, in consultation with the Agency for Health Care Policy and Research, issues related to the
p.000113: quality of life for men after prostrate cancer screening and followup.
p.000113: (4) To develop and disseminate public information and education programs for prostate cancer, including
p.000113: appropriate messages about the risks and benefits of prostate cancer screening for the general
p.000113: public, health care providers, policy makers and other appropriate individuals.
p.000113: (5) To improve surveillance for prostate cancer.
p.000113: (6) To address the needs of underserved and minority pop- ulations regarding prostate cancer.
p.000113: (7) Upon a determination by the Secretary, who shall take into consideration recommendations by the United States Pre-
p.000113: ventive Services Task Force and shall seek input, where appro- priate, from professional societies and other private
p.000113: and public entities, that there is sufficient consensus on the effectiveness of prostate cancer screening—
p.000113: (A) to screen men for prostate cancer as a preventive health measure;
p.000113: (B) to provide appropriate referrals for the medical treatment of men who have been screened under subpara-
p.000113: graph (A) and to ensure, to the extent practicable, the pro- vision of appropriate followup services and support
p.000113: serv- ices such as case management;
p.000113: (C) to establish mechanisms through which State and local health departments can monitor the quality
p.000113: of screening procedures for prostate cancer, including the in- terpretation of such procedures; and
p.000113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000113: (D) to improve, in consultation with the Health Re- sources and Services Administration, the education,
p.000113: train- ing, and skills of health practitioners (including appro- priate allied health professionals) in the
p.000113: detection and con- trol of prostate cancer.
p.000113: (8) To evaluate activities conducted under paragraphs (1) through (7) through appropriate surveillance or
p.000113: program moni- toring activities.
p.000113: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000113: (1) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the applicant involved agrees,
p.000113: with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section,
p.000113: to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an
p.000113: amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such con-
p.000113: tributions may be made directly or through donations from public or private entities.
p.000113: (2) DETERMINATION OF AMOUNT OF NON-FEDERAL CON- TRIBUTION.—
p.000113: (A) Non-Federal contributions required in paragraph
p.000113: (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect
p.000113: or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any
p.000113: significant extent by the Federal Government, may not be included in deter- mining the amount of such
p.000113: non-Federal contributions.
p.000113: (B) In making a determination of the amount of non- Federal contributions for purposes of paragraph (1),
p.000113: the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal
p.000113: contributions made by the applicant involved toward the purpose de- scribed in subsection (a) for the
p.000113: 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such
p.000113: subsection.
p.000113: (C) In making a determination of the amount of non- Federal contributions for purposes of paragraph (1),
p.000113: the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal
p.000113: amounts ex- pended pursuant to title XIX of the Social Security Act by the applicant involved toward the purpose
p.000113: described in paragraphs (1) and (2) of subsection (a).
p.000113: (c) EDUCATION ON SIGNIFICANCE OF EARLY DETECTION.—The Secretary may not make a grant under subsection
p.000113: (a) unless the applicant involved agrees that, in carrying out subsection (a)(3), the applicant will carry
p.000113: out education programs to communicate to men, and to local health officials, the significance of the early
p.000113: de- tection of prostate cancer.
p.000113: (d) REQUIREMENT OF PROVISION OF ALL SERVICES BY DATE CERTAIN.—The Secretary may not make a grant
p.000113: under subsection
p.000113: (a) unless the applicant involved agrees—
p.000113: (1) to ensure that, initially and throughout the period dur- ing which amounts are received pursuant to the grant, not
p.000113: less than 60 percent of the grant is expended to provide each of the
p.000113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000115: PUBLIC HEALTH SERVICE ACT
p.000115: Sec. 317D
p.000115:
p.000115: services or activities described in paragraphs (1) and (2) of such subsection;
p.000115: (2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the
p.000115: services or activi- ties described in such subsection is provided; and
p.000115: (3) to ensure that not more than 40 percent of the grant is expended to provide the services or
p.000115: activities described in paragraphs (3) through (6) of such section 11.
p.000115: (e) ADDITIONAL REQUIRED AGREEMENTS.—
p.000115: (1) PRIORITY FOR LOW-INCOME MEN.—The Secretary may not make a grant under subsection (a) unless the applicant
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p.000117: of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any
p.000117: supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses
p.000117: incurred in complying with such request, expend the amounts withheld.
p.000117: (k) DEFINITION.—For purposes of this section, the term ‘‘units of local government’’ includes Indian tribes.
p.000117: (l) AUTHORIZATION OF APPROPRIATIONS.—
p.000117: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000117: $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 2004.
p.000117: (2) ALLOCATION FOR TECHNICAL ASSISTANCE.—Of the amounts appropriated under paragraph (1) for a
p.000117: fiscal year, the Secretary shall reserve not more than 20 percent for car- rying out subsection (j)(1).
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p.000117: January 30, 2020
p.000117: NATIONAL STRATEGY FOR COMBATING AND ELIMINATING TUBERCULOSIS
p.000117: SEC. 317E. ø247b–6¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000117: Control and Pre- vention, may make grants to States, political subdivisions, and other public entities for
p.000117: preventive health service programs for the prevention, control, and elimination of tuberculosis.
p.000117: (b) RESEARCH AND DEVELOPMENT; DEMONSTRATION PROJECTS; EDUCATION AND TRAINING.—With respect to the
p.000117: prevention, treat- ment, control, and elimination of tuberculosis, the Secretary may, directly or through
p.000117: grants to public or nonprofit private entities, carry out the following:
p.000117: (1) Research, with priority given to research and develop- ment concerning latent tuberculosis infection,
p.000117: strains of tuber- culosis resistant to drugs, and research concerning cases of tu- berculosis that affect certain
p.000117: populations at risk for tuber- culosis.
p.000117: (2) Research and development and related activities to de- velop new tools for the elimination of tuberculosis,
p.000117: including
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000117: Sec. 317E PUBLIC HEALTH SERVICE ACT 118
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p.000117: January 30, 2020
p.000117:
p.000117: drugs, diagnostics, vaccines, and public health interventions, such as directly observed therapy and
p.000117: non-pharmaceutical intervention, and methods to enhance detection and response to outbreaks of tuberculosis,
p.000117: including multidrug resistant tu- berculosis. The Secretary is encouraged to give priority to pro- grammatically
p.000117: relevant research so that new tools can be uti- lized in public health practice.
p.000117: (3) Demonstration projects for—
p.000117: (A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent
p.000117: multidrug resistant and extensively drug resistant strains of tuber- culosis;
p.000117: (B) the intensification of efforts to reduce health dis- parities in the incidence of tuberculosis;
p.000117: (C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among
p.000117: United States-Mexico binational populations, including through expansion of the scope and number of programs
p.000117: that—
p.000117: (i) detect and treat binational cases of tuber- culosis; and
p.000117: (ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
p.000117: (D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are
p.000117: in the United States;
p.000117: (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings
p.000117: docu- mented as having a high risk for tuberculosis; and
p.000117: (F) tuberculosis detection, control, and prevention.
p.000117: (4) Public information and education activities.
p.000117: (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention
p.000117: for health profes- sionals, including allied health personnel and emergency re- sponse employees.
p.000117: (6) Support of Centers to carry out activities under para- graphs (1) through (4).
p.000117: (7) Collaboration with international organizations and for- eign countries in carrying out such activities.
p.000117: (8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance
p.000117: and database management systems with cross-jurisdictional capa- bilities, which shall conform to the standards
p.000117: and implementa- tion specifications for such information technologies as rec- ommended by the Secretary.
p.000117: (c) COOPERATION WITH PROVIDERS OF PRIMARY HEALTH SERV- ICES.—The Secretary may make a grant under subsection (a)
p.000117: or (b) only if the applicant for the grant agrees that, in carrying out ac- tivities under the grant,
p.000117: the applicant will cooperate with public and nonprofit private providers of primary health services or
p.000117: sub- stance abuse services, including entities receiving assistance under section 329, 330, or 340A or under title V or
p.000117: XIX.
p.000117: (d) APPLICATION FOR GRANT.—
p.000117: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) or (b) only if an application for the grant
p.000117: is sub-
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000123: incidence of type 2 diabetes in youth and determine the extent to which type 2 di- abetes is incorrectly
p.000123: diagnosed as type 1 diabetes among chil- dren; and
p.000123: (2) developing and improving laboratory methods to assist in diagnosis, treatment, and prevention of diabetes
p.000123: including, but not limited to, developing noninvasive ways to monitor blood glucose to prevent hypoglycemia
p.000123: and improving existing glucometers that measure blood glucose.
p.000123: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000123: COMPILATION OF DATA ON ASTHMA
p.000123: SEC. 317I. ø247b–10¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for
p.000123: Disease Control and Pre- vention, shall—
p.000123: (1) conduct local asthma surveillance activities to collect data on the prevalence and severity of asthma and
p.000123: the quality of asthma management;
p.000123: (2) compile and annually publish data on the prevalence of children suffering from asthma in each State; and
p.000123: (3) to the extent practicable, compile and publish data on the childhood mortality rate associated with asthma
p.000123: nationally.
p.000123: (b) SURVEILLANCE ACTIVITIES.—The Director of the Centers for Disease Control and Prevention, acting through the
p.000123: representative of the Director on the National Asthma Education Prevention Pro- gram Coordinating Committee, shall, in
p.000123: carrying out subsection (a), provide an update on surveillance activities at each Committee meeting.
p.000123: (c) COLLABORATIVE EFFORTS.—The activities described in sub- section (a)(1) may be conducted in
p.000123: collaboration with eligible enti- ties awarded a grant under section 399L.
p.000123: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000123: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000123:
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p.000123: January 30, 2020
p.000123:
p.000123: EFFECTS OF FOLIC ACID IN PREVENTION OF BIRTH DEFECTS
p.000123: SEC. 317J. ø247b–11¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000123: Control and Pre- vention, shall expand and intensify programs (directly or through grants or contracts) for
p.000123: the following purposes:
p.000123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000125: PUBLIC HEALTH SERVICE ACT
p.000125: Sec. 317K
p.000125:
p.000125: (1) To provide education and training for health profes- sionals and the general public for purposes of
p.000125: explaining the effects of folic acid in preventing birth defects and for purposes of encouraging each woman of
p.000125: reproductive capacity (whether or not planning a pregnancy) to consume on a daily basis a die- tary supplement that
p.000125: provides an appropriate level of folic acid.
p.000125: (2) To conduct research with respect to such education and training, including identifying effective strategies
p.000125: for increas- ing the rate of consumption of folic acid by women of reproduc- tive capacity.
p.000125: (3) To conduct research to increase the understanding of the effects of folic acid in preventing birth
p.000125: defects, including understanding with respect to cleft lip, cleft palate, and heart defects.
p.000125: (4) To provide for appropriate epidemiological activities re- garding folic acid and birth defects, including
p.000125: epidemiological activities regarding neural tube defects.
p.000125: (b) CONSULTATIONS WITH STATES AND PRIVATE ENTITIES.—In carrying out subsection (a), the Secretary shall
p.000125: consult with the States and with other appropriate public or private entities, includ- ing national nonprofit
p.000125: private organizations, health professionals, and providers of health insurance and health plans.
p.000125: (c) TECHNICAL ASSISTANCE.—The Secretary may (directly or through grants or contracts) provide technical
p.000125: assistance to public and nonprofit private entities in carrying out the activities de- scribed in subsection
p.000125: (a).
p.000125: (d) EVALUATIONS.—The Secretary shall (directly or through grants or contracts) provide for the evaluation
p.000125: of activities under subsection (a) in order to determine the extent to which such activi- ties have been effective in
p.000125: carrying out the purposes of the program under such subsection, including the effects on various demo-
p.000125: graphic populations. Methods of evaluation under the preceding sentence may include surveys of knowledge
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p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
p.000125: other groups of women with disproportionately high rates of ma- ternal mortality;
p.000125: (I) activities to reduce disparities in maternity services and outcomes;
p.000125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000127: PUBLIC HEALTH SERVICE ACT
p.000127: Sec. 317K
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p.000127: (J) an examination of the relationship between inter- personal violence and maternal complications and
p.000127: mor- tality;
p.000127: (K) preventing and reducing adverse health con- sequences that may result from smokingand substance
p.000127: abuse and misuse before, during and after pregnancy;
p.000127: (L) preventing infections that cause maternal and in- fant complications; and
p.000127: (M) other areas determined appropriate by the Sec- retary.
p.000127: (c) PREVENTION PROGRAMS.—The Secretary may carry out ac- tivities to promote safe motherhood, including—
p.000127: (1) public education campaigns on healthy pregnancies;
p.000127: (2) education programs for physicians, nurses and other health care providers;
p.000127: (3) activities to promote community support services for pregnant women; and
p.000127: (4) activities to promote physical, mental, and behavioral health during, and up to 1 year following,
p.000127: pregnancy, with an emphasis on prevention of, and treatment for, mental health disorders and substance use
p.000127: disorder.
p.000127: (d) MATERNAL MORTALITY REVIEW COMMITTEES.—
p.000127: (1) IN GENERAL.—In order to participate in the program under subsection (a)(2)(D), the applicable maternal
p.000127: mortality review committee of the State, Indian tribe, or tribal organiza- tion shall—
p.000127: (A) include multidisciplinary and diverse membership that represents a variety of clinical specialties, State,
p.000127: trib- al, or local public health officials, epidemiologists, statisti- cians, community organizations, geographic
p.000127: regions within the area covered by such committee, and individuals or or- ganizations that represent the populations in
p.000127: the area cov- ered by such committee that are most affected by preg- nancy-related deaths or
p.000127: pregnancy-associated deaths and lack of access to maternal health care services; and
p.000127: (B) demonstrate to the Centers for Disease Control and Prevention that such maternal mortality review
p.000127: com- mittee’s methods and processes for data collection and re- view, as required under paragraph (3),
p.000127: use best practices to reliably determine and include all pregnancy-associated deaths and pregnancy-related deaths,
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p.000129: fulfilled by each such State if a single such report is submitted for the partnership.
p.000129: (7) APPROPRIATE MECHANISMS FOR INDIAN TRIBES AND TRIB- AL ORGANIZATIONS.—The Secretary, in consultation with
p.000129: Indian tribes, shall identify and establish appropriate mechanisms for Indian tribes and tribal organizations to
p.000129: demonstrate, report data, and conduct the activities as required for participation in the program described in
p.000129: this subsection. Such mechanisms may include technical assistance with respect to grant applica- tion and
p.000129: submission procedures, and award management ac- tivities.
p.000129: (8) RESEARCH AVAILABILITY.—The Secretary shall develop a process to ensure that data collected under
p.000129: paragraph (5) is made available, as appropriate and practicable, for research purposes, in a manner that
p.000129: protects individually identifiable or potentially identifiable information and that is consistent with State and
p.000129: Federal privacy law.
p.000129: (e) DEFINITIONS.—In this section—
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000129: Sec. 317L PUBLIC HEALTH SERVICE ACT 130
p.000129:
p.000129: (1) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of the
p.000129: Indian Self- Determination and Education Assistance Act;
p.000129: (2) the term ‘‘pregnancy-associated death’’ means a death of a woman, by any cause, that occurs during, or
p.000129: within 1 year following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy; and
p.000129: (3) the term ‘‘pregnancy-related death’’ means a death of a woman that occurs during, or within 1 year
p.000129: following, her pregnancy, regardless of the outcome, duration, or site of the pregnancy—
p.000129: (A) from any cause related to, or aggravated by, the pregnancy or its management; and
p.000129: (B) not from accidental or incidental causes.
p.000129: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000129: to be appropriated
p.000129: $58,000,000 for each of fiscal years 2019 through 2023.
p.000129: PRENATAL AND POSTNATAL HEALTH
p.000129: SEC. 317L. ø247b–13¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: PUBLIC HEALTH SERVICE ACT
p.000131: Sec. 317L–1
p.000131:
p.000131: (C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
p.000131: (b) GRANTS.—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States,
p.000131: local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and
p.000131: other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties.
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p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
p.000133: interpretation, (including determinants of poor oral health among vulnerable populations), a
p.000133: multi-dimensional delivery system for oral health, and to implement science-based programs (including
p.000133: dental sealants and community water fluoridation) to improve oral health.
p.000133: (2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
p.000133: ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through
p.000133: 2014.
p.000133: (e) DEFINITIONS.—For purposes of this section, the term ‘‘In- dian tribe’’ means an Indian tribe or tribal
p.000133: organization as defined in section 4(b) and section 4(c) of the Indian Self-Determination and Education
p.000133: Assistance Act.
p.000133: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000133: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: PUBLIC HEALTH SERVICE ACT
p.000135: Sec. 317O
p.000135:
p.000135: SEC. 317N. ø247b–15¿ SURVEILLANCE AND EDUCATION REGARDING IN- FECTIONS ASSOCIATED WITH ILLICIT DRUG USE AND
p.000135: OTHER RISK FACTORS.
p.000135: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000135: may (directly or through grants to public and nonprofit private entities) provide for programs for the following:
p.000135: (1) To cooperate with States and Indian tribes in imple- menting or maintaining a national system to determine
p.000135: the in- cidence of infections commonly associated with illicit drug use, such as viral hepatitis, human
p.000135: immunodeficiency virus, and in- fective endocarditis, and to assist the States in determining the prevalence of such
p.000135: infections, which may include the reporting of cases of such infections.
p.000135: (2) To identify, counsel, and offer testing to individuals who are at risk of infections described in paragraph
p.000135: (1) result- ing from illicit drug use, receiving blood transfusions prior to July 1992, or other risk factors.
p.000135: (3) To provide appropriate referrals for counseling, testing, and medical treatment of individuals identified
p.000135: under para- graph (2) and to ensure, to the extent practicable, the provision of appropriate follow-up services.
p.000135: (4) To develop and disseminate public information and education programs for the detection and control of
p.000135: infections described in paragraph (1), with priority given to high-risk populations as determined by the
p.000135: Secretary.
p.000135: (5) To improve the education, training, and skills of health professionals in the detection and control of
p.000135: infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use
p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
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p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000135: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000137: 137
p.000137: PUBLIC HEALTH SERVICE ACT
p.000137: Sec. 317P
p.000137:
p.000137: HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 13)
p.000137: SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall—
p.000137: (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe-
p.000137: cial studies that would determine the prevalence in var- ious age groups and populations of specific types of
p.000137: human papillomavirus (referred to in this section as ‘‘HPV’’) in dif- ferent sites in various regions of
p.000137: the United States, through collection of special specimens for HPV using a va- riety of laboratory-based testing
p.000137: and diagnostic tools; and
p.000137: (B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
p.000137: (2) REPORT.—The Secretary shall make a progress report to the Congress with respect to paragraph (1) no
p.000137: later than 1 year after the effective date of this section.
p.000137: (b) PREVENTION ACTIVITIES; EDUCATION PROGRAM.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall conduct
p.000137: preven- tion research on HPV, including—
p.000137: (A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
p.000137: (B) formative research to assist with the development of educational messages and information for the public,
p.000137: for patients, and for their partners about HPV;
p.000137: (C) surveys of physician and public knowledge, atti- tudes, and practices about genital HPV infection; and
p.000137: (D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and
p.000137: dis- seminate educational materials for the public and health care providers regarding HPV and its impact
p.000137: and preven- tion.
p.000137: (2) REPORT; FINAL PROPOSAL.—The Secretary shall make a progress report to the Congress with respect to
p.000137: paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final
p.000137: report not later than 3 years after such effective date, including a detailed summary of the signifi- cant
p.000137: findings and problems and the best strategies to prevent future infections, based on available science.
p.000137: (c) HPV EDUCATION AND PREVENTION.—
p.000137: (1) IN GENERAL.—The Secretary shall prepare and dis- tribute educational materials for health care providers and
p.000137: the public that include information on HPV. Such materials shall address—
p.000137: (A) modes of transmission;
p.000137: (B) consequences of infection, including the link be- tween HPV and cervical cancer;
p.000137:
p.000137:
p.000137:
p.000137:
p.000137: January 30, 2020
p.000137: 13 The typeface and casing of the parenthetical matter in the section heading appears in law with all letter cased
p.000137: in lowercase and in bold face type; however, it is reflect here as it should appear in light face and all
p.000137: small caps.
p.000137: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000139: for a na- tional surveillance program and, to the extent possible, ensure that data be representative of all
p.000139: affected populations and shared in a timely manner. In making awards under this subsection, the Sec-
p.000139: retary may provide direct technical assistance in lieu of cash.
p.000139: (c) COORDINATION WITH CENTERS OF EXCELLENCE.—The Sec- retary shall ensure that epidemiological
p.000139: information under sub- sections (a) and (b) is made available to centers of excellence sup- ported under
p.000139: section 404E(b) by the Director of the National Insti- tutes of Health.
p.000139:
p.000139:
p.000139:
p.000139: January 30, 2020
p.000139: 14 So in law. There is no paragraph (5).
p.000139:
p.000139: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000141: PUBLIC HEALTH SERVICE ACT
p.000141: Sec. 317S
p.000141:
p.000141: (d) DATA.—In carrying out this section, the Secretary may en- sure that any data on patients that is collected
p.000141: as part of the Mus- cular Dystrophy STARnet (under a grant under this section) is reg- ularly updated to reflect
p.000141: changes in patient condition over time.
p.000141: (e) REPORTS AND STUDY.—
p.000141: (1) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of the Paul D. Wellstone Muscular
p.000141: Dys- trophy Community Assistance, Research, and Education Amendments of 2008, and annually
p.000141: thereafter, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate
p.000141: committees of the Congress a report—
p.000141: (A) concerning the activities carried out by MD STARnet site 15 funded under this section during the
p.000141: year for which the report is prepared;
p.000141: (B) containing the data collected and findings derived from the MD STARnet sites each fiscal year (as
p.000141: funded under a grant under this section during fiscal years 2008 through 2012); and
p.000141: (C) that every 2 years outlines prospective data collec- tion objectives and strategies.
p.000141: (2) TRACKING HEALTH OUTCOMES.—The Secretary may pro- vide health outcome data on the health and survival of people
p.000141: with muscular dystrophy.
p.000141: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary to
p.000141: carry out this section.
p.000141: SEC. 317R. ø247b–20¿ FOOD SAFETY GRANTS.
p.000141: (a) IN GENERAL.—The Secretary may award grants to States and Indian tribes (as defined in section 4(e) of the
p.000141: Indian Self-De- termination and Education Assistance Act (25 U.S.C. 450b(e))) to expand participation in
p.000141: networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and
p.000141: maintaining the food safety surveillance, technical, and labora- tory capacity needed for such participation.
p.000141: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000141: to be appropriated
p.000141: $19,500,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011
p.000141: through 2015.
p.000141: SEC. 317S. ø247b–21¿ MOSQUITO-BORNE DISEASES; COORDINATION GRANTS TO STATES; ASSESSMENT AND CONTROL GRANTS TO
p.000141: POLITICAL SUBDIVISIONS.
p.000141: (a) COORDINATION GRANTS TO STATES; ASSESSMENT GRANTS TO
p.000141: POLITICAL SUBDIVISIONS.—
p.000141: (1) IN GENERAL.—With respect to mosquito control pro- grams to prevent and control mosquito-borne diseases
p.000141: (referred to in this section as ‘‘control programs’’), the Secretary, acting through the Director of the
p.000141: Centers for Disease Control and Prevention, may make grants to States for the purpose of—
p.000141: (A) coordinating control programs in the State in- volved; and
p.000141: (B) assisting such State in making grants to political subdivisions of the State to conduct assessments
p.000141: to deter-
p.000141:
p.000141:
p.000141:
p.000141: January 30, 2020
p.000141: 15 So in law. The term ‘‘site’’ probably should be ‘‘sites’’.
p.000141: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000141:
p.000141:
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p.000145: Sec. 317U PUBLIC HEALTH SERVICE ACT 146
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p.000145: (2) representatives of patient advocacy and research orga- nizations that focus on vector-borne diseases,
p.000145: including such organizations that have demonstrated experience in related re- search, public health, data collection,
p.000145: or patient access to care;
p.000145: (3) health information technology experts or other informa- tion management specialists;
p.000145: (4) clinicians, entomologists, vector management profes- sionals, public health professionals, and others
p.000145: with expertise in vector-borne diseases; and
p.000145: (5) researchers, including researchers with experience con- ducting translational research.
p.000145: (c) CENTERS OF EXCELLENCE.—The Secretary, in coordination with the Director of the Centers for Disease
p.000145: Control and Preven- tion, shall award grants, contracts, or cooperative agreements to in- stitutions of higher
p.000145: education for the establishment or continued support of regional centers of excellence in vector-borne diseases to
p.000145: address vector-borne diseases, including tick-borne diseases, by—
p.000145: (1) facilitating collaboration between academia and public health organizations for public health surveillance,
p.000145: prevention, and response activities related to vector-borne diseases, includ- ing tick-borne diseases;
p.000145: (2) providing training for public health entomologists and other health care professionals, as appropriate, to
p.000145: address vec- tor-borne diseases, including tick-borne diseases;
p.000145: (3) conducting research to develop and validate prevention and control tools and methods, including
p.000145: evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease
p.000145: outbreaks; or
p.000145: (4) preparing for and responding to outbreaks of vector- borne diseases, including tick-borne diseases.
p.000145: (d) ELIGIBILITY.—To be eligible to receive a grant, contract, or cooperative agreement under subsection (c),
p.000145: an entity shall submit to the Secretary an application at such time, in such manner, and containing such information
p.000145: as the Secretary may require, includ- ing a description of how the entity will conduct the activities
p.000145: de- scribed in such subsection.
p.000145: (e) REPORTS.—
p.000145: (1) PROGRAM SUMMARY.—An entity receiving an award under subsection (c) shall, not later than one year after
p.000145: receiv- ing such award, and annually thereafter, submit to the Sec- retary a summary of programs and
p.000145: activities funded under the award.
p.000145: (2) PROGRESS REPORT.—Not later than 4 years after the date of enactment of this section, the Secretary shall
p.000145: submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and
p.000145: Commerce of the House of Representatives, a report on the progress made in ad- dressing vector-borne diseases,
p.000145: including tick-borne diseases, through activities carried out under this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000145: to be appropriated
p.000145: $10,000,000 for each of fiscal years 2021 through 2025.
p.000145: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000147: PUBLIC HEALTH SERVICE ACT
p.000147: Sec. 318
p.000147:
p.000147: PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF SEXUALLY TRANSMITTED DISEASES 16
p.000147: SEC. 318. ø247c¿ (a) The Secretary may provide technical as- sistance to appropriate public and non-profit
p.000147: private entities and to scientific institutions for their research in, and training and public health programs for
p.000147: the prevention and control of sexually trans- mitted diseases.
p.000147: (b) The Secretary may make grants to States, political subdivi- sions of States, and any other public and
p.000147: nonprofit private entity for—
p.000147: (1) research into the prevention and control of sexually transmitted diseases;
p.000147: (2) demonstration projects for the prevention and control of sexually transmitted diseases;
p.000147: (3) public information and education programs for the pre- vention and control of such diseases; and
p.000147: (4) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000147: diseases for health professionals (including allied health personnel).
p.000147: (c) The Secretary is also authorized to make project grants to States and, in consultation with the
p.000147: State health authority, to po- litical subdivisions of States, for—
p.000147: (1) sexually transmitted diseases surveillance activities, in- cluding the reporting, screening, and followup of
p.000147: diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
p.000147: (2) casefinding and case followup activities respecting sex- ually transmitted diseases, including contact tracing
p.000147: of infec- tious cases of sexually transmitted diseases and routine test- ing, including laboratory tests and
p.000147: followup systems;
p.000147: (3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
p.000147: (4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and
p.000147: control strat- egies and activities as may be prescribed by the Secretary.
p.000147: (d) The Secretary may make grants to States and political sub- divisions of States for the development,
p.000147: implementation, and eval- uation of innovative, interdisciplinary approaches to the prevention and control of
p.000147: sexually transmitted diseases.
...

p.000149: compliance with criteria issued under subsection (f);
p.000149: (2) providing treatment to women for the disease;
p.000149: (3) providing counseling to women on the prevention and control of the disease (including, in the case
p.000149: of a woman with the disease, counseling on the benefits of locating and pro- viding such counseling
p.000149: to any individual from whom the woman may have contracted the disease and any individual whom the
p.000149: woman may have exposed to the disease);
p.000149: (4) providing follow-up services;
p.000149: (5) referrals for necessary medical services for women screened pursuant to paragraph (1), including
p.000149: referrals for evaluation and treatment with respect to acquired immune de- ficiency syndrome and other sexually
p.000149: transmitted diseases;
p.000149: (6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5),
p.000149: providing to the partner of the woman the services described in such paragraphs, as ap- propriate;
p.000149: (7) providing outreach services to inform women of the availability of the services described in paragraphs (1)
p.000149: through (6);
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p.000149: (8) providing to the public information and education on the prevention and control of the disease,
p.000149: including dissemi- nating such information; and
p.000149: (9) providing training to health care providers in carrying out the screenings and counseling described
p.000149: in paragraphs (1) and (3).
p.000149: (d) REQUIREMENT OF AVAILABILITY OF ALL SERVICES THROUGH EACH GRANTEE.—The Secretary may make a grant under
p.000149: sub- section (a) only if the applicant involved agrees that each activity authorized in subsection (c) will
p.000149: be available through the applicant. With respect to compliance with such agreement, the applicant may expend
p.000149: the grant to carry out any of the activities directly, and may expend the grant to enter into
p.000149: agreements with other public or nonprofit private entities under which the entities carry out the
p.000149: activities.
p.000149: (e) REQUIRED PROVIDERS REGARDING CERTAIN SERVICES.—The Secretary may make a grant under subsection (a) only if the
p.000149: appli- cant involved agrees that, in expending the grant to carry out ac- tivities authorized in subsection
p.000149: (c), the services described in para- graphs (1) through (7) of such subsection will be provided only through
p.000149: entities that are State or local health departments, grant- ees under section 329, 330, 340A, or 1001, or are
p.000149: other public or nonprofit private entities that provide health services to a signifi- cant number of
p.000149: low-income women.
p.000149: (f) QUALITY ASSURANCE REGARDING SCREENING FOR DIS-
p.000149: EASES.—For purposes of this section, the Secretary shall establish
p.000149: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000149:
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p.000153: to a public health emergency or potential public health emer- gency, including further supporting programs under
p.000153: sec- tion 319C–1, 319C–2, or 319C–3;
p.000153: (C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as
p.000153: defined in section 319F–2), qualified countermeasures (as defined in section 319F–1), or qualified pandemic
p.000153: or epi- demic products (as defined in section 319F–3), that are ap- plicable to the public health emergency or
p.000153: potential public health emergency under paragraph (1);
p.000153: (D) strengthen biosurveillance capabilities and labora- tory capacity to identify, collect, and analyze
p.000153: information regarding such public health emergency or potential public health emergency, including the systems
p.000153: under section 319D;
p.000153: (E) support initial emergency operations and assets re- lated to preparation and deployment of intermittent dis-
p.000153: aster response personnel under section 2812 and the Med- ical Reserve Corps under section 2813; and
p.000153: (F) carry out other activities, as the Secretary deter- mines applicable and appropriate.
p.000153: (3) REPORT.—Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the
p.000153: Com- mittee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the
p.000153: Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
p.000153: (A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and
p.000153: (B) each public health emergency for which the ex- penditures were made and the activities undertaken
p.000153: with respect to each emergency which was conducted or sup- ported by expenditures from the Fund.
p.000153: (4) REVIEW.—Not later than 2 years after the date of en- actment of the Pandemic and All-Hazards
p.000153: Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordina- tion with the Assistant
p.000153: Secretary for Preparedness and Re- sponse, shall conduct a review of the Fund under this section and
p.000153: provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appro-
p.000153: priations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the
p.000153: House of Representatives on policies to improve such Fund for the uses described in paragraph (2).
p.000153: (5) GAO REPORT.—Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.000153: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000155: PUBLIC HEALTH SERVICE ACT
p.000155: Sec. 319
p.000155:
p.000155: Advancing Innovation Act of 2019, the Comptroller General of the United States shall—
p.000155: (A) conduct a review of the Fund under this section, including its uses and the resources available in the
p.000155: Fund; and
p.000155: (B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee
p.000155: on Energy and Commerce of the House of Representatives a report on such review, including recommendations
p.000155: related to such review, as applicable.
p.000155: (c) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this section shall be used to rapidly respond to public
p.000155: health emer- gencies or potential public health emergencies and supplement and not supplant other Federal, State,
p.000155: and local public funds provided for activities under this Act or funds otherwise provided for emer- gency
p.000155: response.
p.000155: (d) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or partially
p.000155: as a re- sult of a public health emergency that has been determined pursu- ant to subsection (a), individuals or
p.000155: public or private entities are unable to comply with deadlines for the submission to the Sec- retary of
p.000155: data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any
p.000155: other provi- sion of law, grant such extensions of such deadlines as the cir- cumstances reasonably require,
p.000155: and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly
p.000155: after granting such an extension or waiver, the Sec- retary shall notify the Congress of such action
p.000155: and publish in the Federal Register a notice of the extension or waiver.
p.000155: (e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PER-
p.000155: SONNEL DURING A PUBLIC HEALTH EMERGENCY.—
...

p.000157: used by States and Indian tribes;
p.000157: (B) an analysis of how such temporary reassignment has assisted States and Indian tribes in responding to pub-
p.000157: lic health emergencies;
p.000157: (C) an evaluation of how such temporary reassignment has improved operational efficiencies in responding to pub- lic
p.000157: health emergencies;
p.000157: (D) an analysis of the extent to which, if any, Federal programs from which personnel have been temporarily re-
p.000157: assigned have been adversely affected by the reassign- ment; and
p.000157: (E) recommendations on how medical surge capacity could be improved in responding to public health emer-
p.000157: gencies and the impact of the reassignment flexibility under this section on such surge capacity.
p.000157: (7) DEFINITIONS.—In this subsection—
p.000157: (A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of
p.000157: the In-
p.000157: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000157: Sec. 319 PUBLIC HEALTH SERVICE ACT 158
p.000157: dian Self-Determination and Education Assistance Act; and
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p.000157: (B) the term ‘‘State’’ includes, in addition to the enti- ties listed in the definition of such term
p.000157: in section 2, the Freely Associated States.
p.000157: (8) SUNSET.—This subsection shall terminate on Sep- tember 30, 2023.
p.000157: (f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.—
p.000157: (1) DETERMINATION.—If the Secretary determines, after consultation with such public health officials as may
p.000157: be nec- essary, that—
p.000157: (A)(i) the criteria set forth for a public health emer- gency under paragraph (1) or (2) of subsection (a) has
p.000157: been met; or
p.000157: (ii) a disease or disorder, including a novel and emerg- ing public health threat, is significantly likely to become a
p.000157: public health emergency; and
p.000157: (B) the circumstances of such public health emergency, or potential for such significantly likely public
...

p.000161: phone number);
p.000161: (II) providing for optional registration to partici- pate in volunteer services during processes related
p.000161: to State medical licensing, registration, or certification or renewal of such licensing, registration, or
p.000161: certification; or
p.000161: (III) other mechanisms as the State determines appropriate;
p.000161: (v) a description of how the entity will include the State Unit on Aging in public health emergency pre-
p.000161: paredness;
p.000161: (vi) a description of how, as appropriate, the enti- ty may partner with relevant public and private stake- holders,
p.000161: including public health agencies with specific expertise that may be relevant to public health secu- rity,
p.000161: such as environmental health agencies, in public health emergency preparedness and response;
p.000161: (vii) a description of how, as applicable, such enti- ty may integrate information to account for individ- uals
p.000161: with behavioral health needs following a public health emergency;
p.000161: (viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency
p.000161: preparedness and response plans in public health emergency preparedness, including State educational
p.000161: agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965) and State child care lead
p.000161: agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);
p.000161: (ix) in the case of entities that operate on the United States-Mexico border or the United States-
p.000161: Canada border, a description of the activities such en- tity will carry out under the agreement that are spe-
p.000161: cific to the border area including disease detection, identification, investigation, and preparedness and re-
p.000161: sponse activities related to emerging diseases and in- fectious disease outbreaks whether naturally occurring
p.000161:
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p.000161:
p.000161: January 30, 2020
p.000161: 18 Margin for clause (iv) is so in law.
p.000161:
p.000161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000161: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 162
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p.000183: adverse actions, and encouraging States to waive the application of licensing requirements during a public
p.000183: health emergency;
p.000183: (E) evaluate ways to integrate the practice of telemedi- cine within the National Disaster Medical System; and
p.000183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000185: 185
p.000185: PUBLIC HEALTH SERVICE ACT
p.000185: Sec. 319D
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p.000185: (F) promote greater coordination among existing Fed- eral interagency telemedicine and health information tech-
p.000185: nology initiatives.
p.000185: (2) REPORT.—Not later than 12 months after the date of enactment of the Pandemic and All-Hazards Preparedness
p.000185: Act, the Secretary shall prepare and submit a report to the Com- mittee on Health, Education, Labor, and
p.000185: Pensions of the Sen- ate and the Committee on Energy and Commerce of the House of Representatives regarding the
p.000185: findings and recommenda- tions pursuant to subparagraphs (A) through (F) of paragraph (1).
p.000185: (f) PERSONNEL AUTHORITIES.—
p.000185: (1) SPECIALLY QUALIFIED PERSONNEL.—In addition to any other personnel authorities, to carry out subsections (b)
p.000185: and (c), the Secretary may—
p.000185: (A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease
p.000185: Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by
p.000185: this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such
p.000185: as experts in informatics and data analytics (including experts in prediction, mod- eling, or forecasting),
p.000185: and other related scientific or tech- nical fields; and
p.000185: (B) compensate individuals appointed under subpara- graph (A) in the same manner and subject to the same
p.000185: terms and conditions in which individuals appointed under 9903 of title 5, United States Code, are compensated, with-
p.000185: out regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to
p.000185: classification and General Schedule pay rates.
p.000185: (2) LIMITATIONS.—The Secretary shall exercise the author- ity under paragraph (1) in a manner that is consistent with
p.000185: the limitations described in section 319F–1(e)(2).
p.000185: (g) TIMELINE.—The Secretary shall accomplish the purposes under subsections (b) and (c) no later than
...

p.000187: Director of Agri- cultural Research Services, consistent with the recommendations of the task force established
p.000187: under subsection (a), shall directly or through awards of grants or cooperative agreements to public or
p.000187: private entities provide for the conduct of research, investigations, experiments, demonstrations, and
p.000187: studies in the health sciences that are related to—
p.000187: (1) the development of new therapeutics, including vac- cines and antimicrobials, against resistant pathogens;
p.000187: (2) the development or testing of medical diagnostics to de- tect pathogens resistant to antimicrobials;
p.000187: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000187:
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p.000187: Sec. 319E PUBLIC HEALTH SERVICE ACT 188
p.000187:
p.000187: (3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
p.000187: (4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens
p.000187: (as deter- mined by the Director of the National Institutes of Health in consultation with the task
p.000187: force established under subsection (a)), in collaboration and coordination with the activities of the Department of
p.000187: Defense and the Joint Genome Institute of the Department of Energy; and
p.000187: (5) other relevant research areas.
p.000187: (c) EDUCATION OF MEDICAL AND PUBLIC HEALTH PERSONNEL.— The Secretary, after consultation with the Assistant
p.000187: Secretary for Health, the Surgeon General, the Director of the Centers for Dis- ease Control and
p.000187: Prevention, the Administrator of the Health Re- sources and Services Administration, the Director of the Agency
p.000187: for Healthcare Research and Quality, members of the task force de- scribed in subsection (a), professional
p.000187: organizations and societies, and such other public health officials as may be necessary, shall—
p.000187: (1) develop and implement educational programs to in- crease the awareness of the general public with respect to
p.000187: the public health threat of antimicrobial resistance and the appro- priate use of antibiotics;
p.000187: (2) develop and implement educational programs to in- struct health care professionals in the prudent use
p.000187: of anti- biotics; and
p.000187: (3) develop and implement programs to train laboratory personnel in the recognition or identification of
p.000187: resistance in pathogens.
p.000187: (d) GRANTS.—
p.000187: (1) IN GENERAL.—The Secretary shall award competitive grants to eligible entities to enable such entities to
p.000187: increase the capacity to detect, monitor, and combat antimicrobial resist- ance.
p.000187: (2) ELIGIBLE ENTITIES.—Eligible entities for grants under paragraph (1) shall be State or local public health
...

p.000189: adapting applicable existing curricula and training programs to improve responses to public health emergencies.
p.000189: (2) CURRICULUM.—The public health and medical response training program may include course work related to—
p.000189: (A) medical management of casualties, taking into ac- count the needs of at-risk individuals;
p.000189: (B) public health aspects of public health emergencies;
p.000189: (C) mental health aspects of public health emer- gencies;
p.000189: (D) national incident management, including coordina- tion among Federal, State, local, tribal, international agen-
p.000189: cies, and other entities; and
p.000189: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000189:
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p.000191: PUBLIC HEALTH SERVICE ACT
p.000191: Sec. 319F
p.000191:
p.000191: (E) protecting health care workers and health care first responders from workplace exposures during a public
p.000191: health emergency.
p.000191: (3) PEER REVIEW.—On a periodic basis, products prepared as part of the program shall be rigorously
p.000191: tested and peer-re- viewed by experts in the relevant fields.
p.000191: (4) CREDIT.—The Secretary and the Secretary of Defense shall—
p.000191: (A) take into account continuing professional education requirements of public health and healthcare professions;
p.000191: and
p.000191: (B) cooperate with State, local, and tribal accrediting agencies and with professional associations in
p.000191: arranging for students enrolled in the program to obtain continuing professional education credit for program
p.000191: courses.
p.000191: (5) DISSEMINATION AND TRAINING.—
p.000191: (A) IN GENERAL.—The Secretary may provide for the dissemination and teaching of the materials described
p.000191: in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary.
p.000191: (B) CERTAIN ENTITIES.—The education and training ac- tivities described in subparagraph (A) may be carried out
p.000191: by Federal public health, medical, or dental entities, ap- propriate educational entities, professional
p.000191: organizations and societies, private accrediting organizations, and other nonprofit institutions or entities
p.000191: meeting criteria estab- lished by the Secretary.
p.000191: (C) GRANTS AND CONTRACTS.—In carrying out this sub- section, the Secretary may carry out activities directly or
p.000191: through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
p.000191: (b) ADVICE TO THE FEDERAL GOVERNMENT.—
p.000191: (1) REQUIRED ADVISORY COMMITTEES.—In coordination with the working group under subsection (a), the
p.000191: Secretary shall establish advisory committees in accordance with para- graphs (2) and (3) to provide expert
p.000191: recommendations to assist such working groups in carrying out their respective respon- sibilities under
p.000191: subsections (a) and (b) 19.
p.000191: (2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER- RORISM 20.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the National Advisory Committee on At-Risk In- dividuals and Public Health Emergencies (referred
p.000191: to in this paragraph as the ‘‘Advisory Committee’’).
p.000191:
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p.000191: January 30, 2020
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p.000207: measure, the Secretary shall determine and consider the following:
p.000207: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000209: PUBLIC HEALTH SERVICE ACT
p.000209: Sec. 319F–2
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p.000209: January 30, 2020
p.000209: (i) The quantities of the product that will be need- ed to meet the stockpile needs.
p.000209: (ii) The feasibility of production and delivery with- in 10 years of sufficient quantities of the product.
p.000209: (iii) Whether there is a lack of a significant com- mercial market for the product at the time of procure-
p.000209: ment, other than as a security countermeasure.
p.000209: (6) RECOMMENDATIONS FOR PROCUREMENT.—
p.000209: (A) NOTICE TO APPROPRIATE CONGRESSIONAL COMMIT- TEES.—The Secretary shall notify the Committee on Appro- priations
p.000209: and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appro-
p.000209: priations and the Committee on Energy and Commerce of the House of Representatives of each decision to
p.000209: make available the special reserve fund as defined in subsection
p.000209: (h) for procurement of a security countermeasure, includ- ing, where available, the number of, the nature
p.000209: of, and other information concerning potential suppliers of such countermeasure, and whether other
p.000209: potential suppliers of the same or similar countermeasures were considered and rejected for procurement under
p.000209: this section and the rea- sons for each such rejection.
p.000209: (B) SUBSEQUENT SPECIFIC COUNTERMEASURES.—Pro- curement under this subsection of a security
p.000209: counter- measure for a particular purpose does not preclude the subsequent procurement under this
p.000209: subsection of any other security countermeasure for such purpose if the Sec- retary has determined under
p.000209: paragraph (5)(A) that such countermeasure is appropriate for inclusion in the stock- pile and if, as
p.000209: determined by the Secretary, such counter- measure provides improved safety or effectiveness, or for other
p.000209: reasons enhances preparedness to respond to threats of use of a biological, chemical, radiological, or nuclear
p.000209: agent. Such a determination by the Secretary is committed to agency discretion.
p.000209: (7) PROCUREMENT.—
p.000209: (A) PAYMENTS FROM SPECIAL RESERVE FUND.—The spe- cial reserve fund as defined in subsection (h) shall be
p.000209: available for payments made by the Secretary to a vendor for procurement of a security countermeasure in accord-
p.000209: ance with the provisions of this paragraph.
p.000209: (B) PROCUREMENT.—
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p.000215: January 30, 2020
p.000215:
p.000215: 319L (relating to the Biomedical Advanced Research and De- velopment Authority), $7,100,000,000 for the
p.000215: period of fiscal years 2019 through 2028, to remain available until expended.
p.000215: (2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RE- SEARCH AND DEVELOPMENT.—The Secretary may
p.000215: utilize not more than 50 percent of the amounts authorized to be appro- priated under paragraph (1) to carry
p.000215: out section 319L (related to the Biomedical Advanced Research and Development Au- thority). Amounts authorized
p.000215: to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized
p.000215: to be appropriated to carry out such sec- tion.
p.000215: (3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the spe- cial reserve fund shall not be used to pay costs other than
p.000215: pay- ments made by the Secretary to a vendor for advanced develop- ment (under section 319L) or for procurement
p.000215: of a security countermeasure under subsection (c)(7).
p.000215: (4) REPORT ON SECURITY COUNTERMEASURE PROCURE- MENT.—Not later than March 1 of each year in which the
p.000215: Sec- retary determines that the amount of funds available for pro- curement of security
p.000215: countermeasures is less than
p.000215: $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health,
p.000215: Education, Labor, and Pensions of the Senate and the Committee on Ap- propriations and the Committee on
p.000215: Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for
p.000215: procurement and the impact such amount of funding will have—
p.000215: (A) in meeting the security countermeasure needs identified under this section; and
p.000215: (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan
p.000215: (pursuant to section 2811(d)).
p.000215: (5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Sec- retary, acting through the Director of the Biomedical
p.000215: Advanced Research and Development Authority, shall carry out the pro- grams funded by the special reserve fund
p.000215: (for the procurement of security countermeasures under subsection (c) and for car- rying out section 319L),
p.000215: including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and
p.000215: section 319L.
p.000215: (h) DEFINITIONS.—In this section:
p.000215: (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a).
p.000215: (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any
p.000215: appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation
p.000215: made available pur- suant to subsection (g)(1).
p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
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p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000231:
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p.000231: Sec. 319H PUBLIC HEALTH SERVICE ACT 232
p.000231:
p.000231: (4) Whether the entity is proximate to, and collaborates with, or is, an academic medical center that
p.000231: has the capacity to serve an uninsured or underserved population, and is equipped to educate medical
p.000231: personnel.
p.000231: (5) Such other factors as the Secretary determines to be appropriate.
p.000231: (d) DURATION OF AWARD.—The period during which payments are made under a grant under subsection (a) may
p.000231: not exceed 5 years. The provision of such payments shall be subject to annual approval by the Secretary of
p.000231: the payments and subject to the avail- ability of appropriations for the fiscal year involved to make the
p.000231: payments.
p.000231: (e) SUPPLEMENT NOT SUPPLANT.—Grants under subsection (a) shall be used to supplement, and not supplant,
p.000231: other Federal, State, or local public funds provided for the activities described in such subsection.
p.000231: (f) GENERAL ACCOUNTING OFFICE REPORT 24.—Not later than 180 days after the conclusion of the
p.000231: demonstration programs car- ried out under subsection (a), the Comptroller General of the United States
p.000231: shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of
p.000231: the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of
p.000231: Representatives, a report that de- scribes the ability of grantees under such subsection to detect
p.000231: pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such
p.000231: threats, and train personnel involved with the various responsibilities and capabilities needed to deal with
p.000231: bioterrorist threats.
p.000231: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000231: $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006.
p.000231: SEC. 319H. ø247d–7a¿ GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH PROFESSIONALS.
p.000231: (a) IN GENERAL.—The Secretary may make awards of grants and cooperative agreements to appropriate public
p.000231: and nonprofit private health or educational entities, including health professions schools and programs as
p.000231: defined in section 799B, for the purpose of providing low-interest loans, partial scholarships, partial fellow-
p.000231: ships, revolving loan funds, or other cost-sharing forms of assist- ance for the education and training
p.000231: of individuals in any category of health professions for which there is a shortage that the Sec- retary
p.000231: determines should be alleviated in order to prepare for or re- spond effectively to bioterrorism and other public
p.000231: health emer- gencies.
p.000231: (b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.— The Secretary may require as a condition of an
p.000231: award under sub- section (a) that a grantee under such subsection provide non-Fed- eral contributions toward
p.000231: the purpose described in such subsection.
p.000231: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000231: to be appropriated
p.000231:
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p.000231: January 30, 2020
p.000231: 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814).
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: PUBLIC HEALTH SERVICE ACT
p.000233: Sec. 319I
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p.000245: (ii) shall be deemed to be information described in sec- tion 552(b)(3) of title 5, United States Code.
p.000245: (ii) INFORMATION DESCRIBED.—The information de- scribed in this clause is information relevant to pro- grams of
p.000245: the Department of Health and Human Serv- ices that could compromise national security and re- veal significant
p.000245: and not otherwise publicly known vulnerabilities of existing medical or public health de- fenses against
p.000245: chemical, biological, radiological, or nu- clear threats, and is comprised of—
p.000245: (I) specific technical data or scientific informa- tion that is created or obtained during the coun- termeasure
p.000245: and product advanced research and development carried out under subsection (c);
p.000245: (II) information pertaining to the location se- curity, personnel, and research materials and methods
p.000245: of high-containment laboratories con- ducting research with select agents, toxins, or other agents
p.000245: with a material threat determination under section 319F–2(c)(2); or
p.000245: (III) security and vulnerability assessments.
p.000245: (B) REVIEW.—Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary
p.000245: every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or
p.000245: necessity of continued nondisclosure.
p.000245: (C) REPORTING.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Ad-
p.000245: vancing Innovation Act of 2019, and annually thereafter, the Secretary shall report to the Committee on
p.000245: Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
p.000245: Rep- resentatives on the number of instances in which the Sec- retary has used the authority under this
p.000245: subsection to withhold information from disclosure, as well as the na- ture of any request under section
p.000245: 552 of title 5, United States Code that was denied using such authority.
p.000245: (D) SUNSET.—This paragraph shall cease to have force or effect on the date that is 17 years after the date of en-
p.000245: actment of the Pandemic and All-Hazards Preparedness Act.
p.000245: (2) REVIEW.—Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA
p.000245: under this section and the National Biodefense Science Board under section 319M shall each terminate on
p.000245: the date that is 5 years after the date on which each such group or Board, as applica- ble, was established.
p.000245: Such 5-year period may be extended by
p.000245: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000245: Sec. 319L–1 PUBLIC HEALTH SERVICE ACT 246
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p.000253: facili- ties, except that the rate may not exceed the comparable costs per patient with Hansen’s disease for care
p.000253: and treatment provided by the Center referred to in subsection (a). Payments under this sub- section are subject
p.000253: to the availability of appropriations for such purpose.
p.000253:
p.000253: COORDINATED PROGRAM TO IMPROVE PEDIATRIC ORAL HEALTH
p.000253: SEC. 320A. 26 ø247d–8¿ (a) IN GENERAL.—The Secretary, acting through the Administrator of the Health Resources
p.000253: and Services Administration, shall establish a program to fund innovative oral health activities that
p.000253: improve the oral health of children under 6 years of age who are eligible for services provided under a Federal
p.000253: health program, to increase the utilization of dental services by such children, and to decrease the incidence
p.000253: of early childhood and baby bottle tooth decay.
p.000253: (b) GRANTS.—The Secretary shall award grants to or enter into contracts with public or private nonprofit schools of
p.000253: dentistry or ac- credited dental training institutions or programs, community den- tal programs, and programs
p.000253: operated by the Indian Health Service (including federally recognized Indian tribes that receive medical
p.000253: services from the Indian Health Service, urban Indian health pro- grams funded under title V of the
p.000253: Indian Health Care Improve- ment Act, and tribes that contract with the Indian Health Service pursuant to
p.000253: the Indian Self-Determination and Education Assist- ance Act) to enable such schools, institutions, and programs
p.000253: to de- velop programs of oral health promotion, to increase training of oral health services providers in
p.000253: accordance with State practice
p.000253:
p.000253:
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p.000253:
p.000253: January 30, 2020
p.000253: 25 Title II of Public Law 105–78. See 111 Stat. 1477, 1489.
p.000253: 26 The placement of this section in title III was carried out to reflect the probable intent of
p.000253: Congress. Section 1603 of Public Law 106–310 (114 Stat. 1151) provided for an amendment to ‘‘Part B of
p.000253: the Public Health Service Act’’, without specifying which title of this Act was the subject of the
p.000253: amendment.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000253: Sec. 321 PUBLIC HEALTH SERVICE ACT 254
p.000253: laws, or to increase the utilization of dental services by eligible children.
p.000253: (c) DISTRIBUTION.—In awarding grants under this section, the Secretary shall, to the extent practicable,
p.000253: ensure an equitable na- tional geographic distribution of the grants, including areas of the United States
p.000253: where the incidence of early childhood caries is high- est.
p.000253: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
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p.000255: (c) The Service shall provide all services referred to in sub- section (a) required by the Coast Guard or
p.000255: Coast and Geodetic Sur- vey and shall perform all duties prescribed by statute in connection with the examinations
p.000255: to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, pro-
p.000255: motion and retirement, and officers of the Service assigned to duty on Coast Guard or Coast and Geodetic Survey
p.000255: vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
p.000255:
p.000255: January 30, 2020 As Amended Through P.L. 116-94,
p.000255: Enacted December 20, 2019
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p.000257: PUBLIC HEALTH SERVICE ACT
p.000257: Sec. 330
p.000257:
p.000257: INTERDEPARTMENTAL WORK
p.000257: SEC. 327. ø254¿ Nothing contained in this part shall affect the authority of the Service to furnish any
p.000257: materials, supplies, or equipment, or perform any work or services, requested in accord- ance with section 7
p.000257: of the Act of May 21, 1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or the authority of any other execu-
p.000257: tive department to furnish any materials, supplies, or equipment, or perform any work or services,
p.000257: requested by the Department of Health, Education, and Welfare for the Service in accordance with that section.
p.000257:
p.000257: SHARING OF MEDICAL CARE FACILITIES AND RESOURCES
p.000257: SEC. 327A. ø254a¿ (a) For purposes of this section—
p.000257: (1) the term ‘‘specialized health resources’’ means health care resources (whether equipment, space, or
p.000257: personnel) which, because of cost, limited availability, or unusual nature, are ei- ther unique in the health care
p.000257: community or are subject to maximum utilization only through mutual use;
p.000257: (2) the term ‘‘hospital’’, unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.
p.000257: (b) For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide
p.000257: a professional environment therein which will help to attract and retain highly qualified and talented
p.000257: health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and
p.000257: hospitals and other health facilities in the health care commu- nity, and to promote the full utilization of
p.000257: hospitals and other health facilities and resources, the Secretary may—
p.000257: (1) enter into agreements or arrangements with schools of medicine, schools of osteopathic medicine, and
p.000257: with other health professions schools, agencies, or institutions, for such interchange or cooperative use of
p.000257: facilities and services on a re- ciprocal or reimbursable basis, as will be of benefit to the training or
p.000257: research programs of the participating agencies; and
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p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
p.000259: (B) recuperative care services;
p.000259: (C) environmental health services, including—
p.000259: (i) the detection and alleviation of unhealthful conditions associated with—
p.000259: (I) water supply;
p.000259: (II) chemical and pesticide exposures;
p.000259: (III) air quality; or
p.000259: (IV) exposure to lead;
p.000259: (ii) sewage treatment;
p.000259: (iii) solid waste disposal;
p.000259: (iv) rodent and parasitic infestation;
p.000259: (v) field sanitation;
p.000259: (vi) housing; and
p.000259: (vii) other environmental factors related to health;
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p.000275: PUBLIC HEALTH SERVICE ACT
p.000275: Sec. 330
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p.000275: January 30, 2020
p.000275: (B) DISTRIBUTION OF GRANTS.—For fiscal year 2002 and each of the following fiscal years, the
p.000275: Secretary, in awarding grants under this section, shall ensure that the proportion of the amount made
p.000275: available under each of subsections (g), (h), and (i), relative to the total amount ap- propriated to carry out
p.000275: this section for that fiscal year, is equal to the proportion of the amount made available under that
p.000275: subsection for fiscal year 2001, relative to the total amount appropriated to carry out this section for fis-
p.000275: cal year 2001.
p.000275: (3) FUNDING REPORT.—The Secretary shall annually pre- pare and submit to the Committee on Health,
p.000275: Education, Labor, and Pensions of the Senate, and the Committee on En- ergy and Commerce of the House of
p.000275: Representatives, a report including, at a minimum—
p.000275: (A) the distribution of funds for carrying out this sec- tion that are provided to meet the health
p.000275: care needs of medically underserved populations, including the home- less, residents of public housing, and
p.000275: migratory and sea- sonal agricultural workers, and the appropriateness of the delivery systems involved in
p.000275: responding to the needs of the particular populations;
p.000275: (B) an assessment of the relative health care access needs of the targeted populations;
p.000275: (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban
p.000275: areas;
p.000275: (D) the distribution of awards and funding for estab- lishing new access points, and the number of new
p.000275: access points created;
p.000275: (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI;
p.000275: (F) the rationale for any substantial changes in the distribution of funds;
p.000275: (G) the rate of closures for health centers and access points;
p.000275: (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and
p.000275: (I) the number and reason for any waivers provided pursuant to subsection (q)(4).
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p.000283: January 30, 2020
p.000283: public or nonprofit private entities for the establishment and oper- ation of regional centers whose purpose is to
p.000283: develop, evaluate, and disseminate effective strategies, which utilize quality management measures, to assist
p.000283: public and private health care programs and providers in the appropriate utilization of preventive health
p.000283: care services by specific populations.
p.000283: (b) RESEARCH AND TRAINING.—The activities carried out by a center under subsection (a) may include
p.000283: establishing programs of research and training with respect to the purpose described in such subsection, including
p.000283: the development of curricula for training indi- viduals in implementing the strategies developed under such
p.000283: sub- section.
p.000283: (c) PRIORITY REGARDING INFANTS AND CHILDREN.—In carrying out the purpose described in subsection (a), the
p.000283: Secretary shall give priority to various populations of infants, young children, and their mothers.
p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004.
p.000283: SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
p.000283: (a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
p.000283: (1) IN GENERAL.—The Secretary shall develop and imple- ment public health surveillance, education, research, and
p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
p.000283: targeted to parents, schools, daycare providers, patients;
p.000283: (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig-
p.000283: mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth;
p.000283: (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and
p.000283: related needs of people with disabilities; and
p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000289: ‘‘medically underserved community’’ in section 799B(6).
p.000289: (5) MEDICALLY UNDERSERVED POPULATION.—The term ‘‘medically underserved population’’ has the meaning given
p.000289: the term in section 330(b)(3).
p.000289: (6) TELEHEALTH SERVICES.—The term ‘‘telehealth services’’ means services provided through telehealth technologies.
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000289:
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p.000291: PUBLIC HEALTH SERVICE ACT
p.000291: Sec. 330I
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p.000291: January 30, 2020
p.000291: (7) TELEHEALTH TECHNOLOGIES.—The term ‘‘telehealth technologies’’ means technologies relating to the use
p.000291: of elec- tronic information, and telecommunications technologies, to support and promote, at a
p.000291: distance, health care, patient and professional health-related education, health administration, and public
p.000291: health.
p.000291: (b) PROGRAMS.—The Secretary shall establish, under section 301, telehealth network and telehealth resource
p.000291: centers grant pro- grams.
p.000291: (c) ADMINISTRATION.—
p.000291: (1) ESTABLISHMENT.—There is established in the Health Resources and Services Administration an Office for
p.000291: the Ad- vancement of Telehealth. The Office shall be headed by a Di- rector.
p.000291: (2) DUTIES.—The telehealth network and telehealth re- source centers grant programs established under
p.000291: section 301 shall be administered by the Director, in consultation with the State offices of rural health, State
p.000291: offices concerning primary care, or other appropriate State government entities.
p.000291: (d) GRANTS.—
p.000291: (1) TELEHEALTH NETWORK GRANTS.—The Director may, in carrying out the telehealth network grant program referred to
p.000291: in subsection (b), award grants to eligible entities for projects to demonstrate how telehealth
p.000291: technologies can be used through telehealth networks in rural areas, frontier commu- nities, and medically
p.000291: underserved areas, and for medically un- derserved populations, to—
p.000291: (A) expand access to, coordinate, and improve the quality of health care services;
p.000291: (B) improve and expand the training of health care providers; and
p.000291: (C) expand and improve the quality of health informa- tion available to health care providers, and patients and
p.000291: their families, for decisionmaking.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—The Director may, in carrying out the telehealth resource centers grant pro-
...

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p.000291: January 30, 2020
p.000291:
p.000291: (ii) NATURE OF ENTITIES.—Each entity partici- pating in the telehealth network may be a nonprofit or
p.000291: for-profit entity.
p.000291: (iii) COMPOSITION OF NETWORK.—The telehealth network shall include at least 2 of the following enti- ties
p.000291: (at least 1 of which shall be a community-based health care provider):
p.000291: (I) Community or migrant health centers or other Federally qualified health centers.
p.000291: (II) Health care providers, including phar- macists, in private practice.
p.000291: (III) Entities operating clinics, including rural health clinics.
p.000291: (IV) Local health departments.
p.000291: (V) Nonprofit hospitals, including community access hospitals.
p.000291: (VI) Other publicly funded health or social service agencies.
p.000291: (VII) Long-term care providers.
p.000291: (VIII) Providers of health care services in the home.
p.000291: (IX) Providers of outpatient mental health services and entities operating outpatient mental health
p.000291: facilities.
p.000291: (X) Local or regional emergency health care providers.
p.000291: (XI) Institutions of higher education.
p.000291: (XII) Entities operating dental clinics.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—To be eligi- ble to receive a grant under subsection (d)(2), an
p.000291: entity shall be a nonprofit entity.
p.000291: (g) APPLICATIONS.—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation
p.000291: with the appropriate State office of rural health or another appropriate State entity, shall prepare and
p.000291: submit to the Secretary an application, at such time, in such manner, and containing such information as the
p.000291: Sec- retary may require, including—
p.000291: (1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000291: (2) a description of the manner in which the project funded under the grant will meet the health care needs of
p.000291: rural or other populations to be served through the project, or improve the access to services of, and the
p.000291: quality of the services re- ceived by, those populations;
p.000291: (3) evidence of local support for the project, and a descrip- tion of how the areas, communities, or populations to be
p.000291: served will be involved in the development and ongoing operations of the project;
p.000291: (4) a plan for sustaining the project after Federal support for the project has ended;
p.000291: (5) information on the source and amount of non-Federal funds that the entity will provide for the project;
p.000291: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000293: publication of the Health Resources and Services Administration, notice of the application requirements for
p.000293: each grant program de- scribed in subsection (b) for each fiscal year.
p.000293: (i) PREFERENCES.—
p.000293: (1) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for projects involving telehealth networks,
p.000293: the Secretary shall give preference to an eligible entity that meets at least 1 of the following requirements:
p.000293: (A) ORGANIZATION.—The eligible entity is a rural com- munity-based organization or another community-based or-
p.000293: ganization.
p.000293: (B) SERVICES.—The eligible entity proposes to use Fed- eral funds made available through such a grant to develop plans
p.000293: for, or to establish, telehealth networks that provide mental health, public health, long-term care, home care,
p.000293: preventive, case management services, or prenatal care for high-risk pregnancies.
p.000293: (C) COORDINATION.—The eligible entity demonstrates how the project to be carried out under the grant will
p.000293: be coordinated with other relevant federally funded projects in the areas, communities, and populations to
p.000293: be served through the grant.
p.000293: (D) NETWORK.—The eligible entity demonstrates that the project involves a telehealth network that includes
p.000293: an entity that—
p.000293: (i) provides clinical health care services, or edu- cational services for health care providers and for
p.000293: pa- tients or their families; and
p.000293: (ii) is—
p.000293: (I) a public library;
p.000293: (II) an institution of higher education; or
p.000293: (III) a local government entity.
p.000293: (E) CONNECTIVITY.—The eligible entity proposes a project that promotes local connectivity within areas, com-
p.000293: munities, or populations to be served through the project.
p.000293: (F) INTEGRATION.—The eligible entity demonstrates that health care information has been integrated into
p.000293: the project.
p.000293: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000293:
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p.000293:
p.000293: Sec. 330I PUBLIC HEALTH SERVICE ACT 294
p.000293:
p.000293: (2) TELEHEALTH RESOURCE CENTERS.—In awarding grants under subsection (d)(2) for projects involving
p.000293: telehealth re- source centers, the Secretary shall give preference to an eligi- ble entity that meets at
p.000293: least 1 of the following requirements:
p.000293: (A) PROVISION OF SERVICES.—The eligible entity has a record of success in the provision of telehealth services
p.000293: to medically underserved areas or medically underserved populations.
p.000293: (B) COLLABORATION AND SHARING OF EXPERTISE.—The eligible entity has a demonstrated record of collaborating
p.000293: and sharing expertise with providers of telehealth services at the national, regional, State, and local levels.
p.000293: (C) BROAD RANGE OF TELEHEALTH SERVICES.—The eli- gible entity has a record of providing a broad range of tele-
p.000293: health services, which may include—
p.000293: (i) a variety of clinical specialty services;
p.000293: (ii) patient or family education;
p.000293: (iii) health care professional education; and
p.000293: (iv) rural residency support programs.
p.000293: (j) DISTRIBUTION OF FUNDS.—
p.000293: (1) IN GENERAL.—In awarding grants under this section, the Director shall ensure, to the greatest extent
p.000293: possible, that such grants are equitably distributed among the geographical regions of the United States.
p.000293: (2) TELEHEALTH NETWORKS.—In awarding grants under subsection (d)(1) for a fiscal year, the Director shall
p.000293: ensure that—
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p.000293: January 30, 2020
p.000293: (A) not less than 50 percent of the funds awarded shall be awarded for projects in rural areas; and
p.000293: (B) the total amount of funds awarded for such projects for that fiscal year shall be not less than the
p.000293: total amount of funds awarded for such projects for fiscal year 2001 under section 330A (as in effect on the
p.000293: day before the date of enactment of the Health Care Safety Net Amend- ments of 2002).
p.000293: (k) USE OF FUNDS.—
p.000293: (1) TELEHEALTH NETWORK PROGRAM.—The recipient of a grant under subsection (d)(1) may use funds received
p.000293: through such grant for salaries, equipment, and operating or other costs, including the cost of—
p.000293: (A) developing and delivering clinical telehealth serv- ices that enhance access to community-based health
p.000293: care services in rural areas, frontier communities, or medically underserved areas, or for medically
p.000293: underserved popu- lations;
p.000293: (B) developing and acquiring, through lease or pur- chase, computer hardware and software, audio and
p.000293: video equipment, computer network equipment, interactive equipment, data terminal equipment, and other
p.000293: equipment that furthers the objectives of the telehealth network grant program;
p.000293: (C)(i) developing and providing distance education, in a manner that enhances access to care in rural areas,
p.000293: fron-
p.000293: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000295: PUBLIC HEALTH SERVICE ACT
p.000295: Sec. 330I
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p.000295: tier communities, or medically underserved areas, or for medically underserved populations; or
p.000295: (ii) mentoring, precepting, or supervising health care providers and students seeking to become health care pro-
p.000295: viders, in a manner that enhances access to care in the areas and communities, or for the populations,
p.000295: described in clause (i);
p.000295: (D) developing and acquiring instructional program- ming;
p.000295: (E)(i) providing for transmission of medical data, and maintenance of equipment; and
...

p.000295: providers, who are providing telehealth services through the tele- health network, if no third party
p.000295: payment is available for the telehealth services delivered through the telehealth network;
p.000295: (F) developing projects to use telehealth technology to facilitate collaboration between health care providers;
p.000295: (G) collecting and analyzing usage statistics and data to document the cost-effectiveness of the
p.000295: telehealth serv- ices; and
p.000295: (H) carrying out such other activities as are consistent with achieving the objectives of this section, as determined
p.000295: by the Secretary.
p.000295: (2) TELEHEALTH RESOURCE CENTERS.—The recipient of a grant under subsection (d)(2) may use funds received
p.000295: through such grant for salaries, equipment, and operating or other costs for—
p.000295: (A) providing technical assistance, training, and sup- port, and providing for travel expenses, for health care
p.000295: pro- viders and a range of health care entities that provide or will provide telehealth services;
p.000295: (B) disseminating information and research findings related to telehealth services;
p.000295: (C) promoting effective collaboration among telehealth resource centers and the Office;
p.000295: (D) conducting evaluations to determine the best utili- zation of telehealth technologies to meet health care needs;
p.000295: (E) promoting the integration of the technologies used in clinical information systems with other telehealth tech-
p.000295: nologies;
p.000295: (F) fostering the use of telehealth technologies to pro- vide health care information and education for health
p.000295: care providers and consumers in a more effective manner; and
p.000295: (G) implementing special projects or studies under the direction of the Office.
p.000295: (l) PROHIBITED USES OF FUNDS.—An entity that receives a grant under this section may not use funds made
p.000295: available through the grant—
p.000295: (1) to acquire real property;
p.000295: (2) for expenditures to purchase or lease equipment, to the extent that the expenditures would exceed 40 percent
p.000295: of the total grant funds;
p.000295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000295:
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p.000295: Sec. 330I PUBLIC HEALTH SERVICE ACT 296
p.000295:
p.000295: (3) in the case of a project involving a telehealth network, to purchase or install transmission equipment (such
p.000295: as laying cable or telephone lines, or purchasing or installing microwave towers, satellite dishes, amplifiers, or
p.000295: digital switching equip- ment);
p.000295: (4) to pay for any equipment or transmission costs not di- rectly related to the purposes for which the grant
p.000295: is awarded;
p.000295: (5) to purchase or install general purpose voice telephone systems;
p.000295: (6) for construction; or
p.000295: (7) for expenditures for indirect costs (as determined by the Secretary), to the extent that the
p.000295: expenditures would ex- ceed 15 percent of the total grant funds.
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p.000299: PUBLIC HEALTH SERVICE ACT
p.000299: Sec. 330K
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p.000299: January 30, 2020
p.000299: (3) SPECIAL POPULATIONS.—The term ‘‘special populations’’ refers to the following 2 distinct groups:
p.000299: (A) Children and adolescents in mental health under- served rural areas or in mental health underserved urban
p.000299: areas.
p.000299: (B) Elderly individuals located in long-term care facili- ties in mental health underserved rural or urban areas.
p.000299: (4) TELEHEALTH.—The term ‘‘telehealth’’ means the use of electronic information and telecommunications
p.000299: technologies to support long distance clinical health care, patient and profes- sional health-related
p.000299: education, public health, and health ad- ministration.
p.000299: (b) PROGRAM AUTHORIZED.—
p.000299: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Office for the Advancement of Telehealth
p.000299: of the Health Resources and Services Administration, shall award grants to eligible entities to establish
p.000299: demonstration projects for the provision of mental health services to special popu- lations as delivered
p.000299: remotely by qualified mental health profes- sionals using telehealth and for the provision of education re-
p.000299: garding mental illness as delivered remotely by qualified men- tal health professionals using telehealth.
p.000299: (2) POPULATIONS SERVED.—The Secretary shall award the grants under paragraph (1) in a manner that
p.000299: distributes the grants so as to serve equitably the populations described in subparagraphs (A) and (B) of
p.000299: subsection (a)(3).
p.000299: (c) USE OF FUNDS.—
p.000299: (1) IN GENERAL.—An eligible entity that receives a grant under this section shall use the grant funds—
p.000299: (A) for the populations described in subsection (a)(3)(A)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, as delivered
p.000299: remotely by qualified mental health professionals using telehealth; and
p.000299: (ii) to collaborate with local public health entities to provide the mental health services; and
p.000299: (B) for the populations described in subsection (a)(3)(B)—
p.000299: (i) to provide mental health services, including di- agnosis and treatment of mental illness, in long-term care
p.000299: facilities as delivered remotely by qualified men- tal health professionals using telehealth; and
p.000299: (ii) to collaborate with local public health entities to provide the mental health services.
p.000299: (2) OTHER USES.—An eligible entity that receives a grant under this section may also use the grant funds to—
p.000299: (A) pay telecommunications costs; and
p.000299: (B) pay qualified mental health professionals on a rea- sonable cost basis as determined by the Secretary for serv-
p.000299: ices rendered.
...

p.000307: (i) DISSEMINATION.—The Administrator of the Health Re- sources and Services Administration shall
p.000307: disseminate information concerning the designation criteria described in subsection (b) to—
p.000307: (1) the Governor of each State;
p.000307: (2) the representative of any area, population group, or fa- cility selected by any such Governor to receive
p.000307: such informa- tion;
p.000307: (3) the representative of any area, population group, or fa- cility that requests such information; and
p.000307: (4) the representative of any area, population group, or fa- cility determined by the Administrator to be likely to
p.000307: meet the criteria described in subsection (b).
p.000307: (j)(1) The Secretary shall submit the report described in para- graph (2) if the Secretary, acting through the
p.000307: Administrator of the Health Resources and Services Administration, issues—
p.000307: (A) a regulation that revises the definition of a health pro- fessional shortage area for purposes of this section; or
p.000307: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000309: PUBLIC HEALTH SERVICE ACT
p.000309: Sec. 333
p.000309:
p.000309: (B) a regulation that revises the standards concerning pri- ority of such an area under section 333A.
p.000309: (2) On issuing a regulation described in paragraph (1), the Sec- retary shall prepare and submit to the
p.000309: Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education,
p.000309: Labor, and Pensions of the Senate a report that describes the regulation.
p.000309: (3) Each regulation described in paragraph (1) shall take effect 180 days after the committees described in
p.000309: paragraph (2) receive a report referred to in such paragraph describing the regulation.
p.000309: (k)(1) The Secretary, acting through the Administrator of the Health Resources and Services
p.000309: Administration, shall identify, based on the data collected under paragraph (3), maternity care health
p.000309: professional target areas that satisfy the criteria described in paragraph (2) for purposes of, in
p.000309: connection with receipt of as- sistance under this title, assigning to such identified areas mater- nity
p.000309: care health professionals who, without application of this sub- section, would otherwise be eligible for such
p.000309: assistance. The Sec- retary shall distribute maternity care health professionals within health professional
p.000309: shortage areas using the maternity care health professional target areas so identified.
p.000309: (2) For purposes of paragraph (1), the Secretary shall establish
p.000309: criteria for maternity care health professional target areas that identify geographic areas within health
p.000309: professional shortage areas that have a shortage of maternity care health professionals.
p.000309: (3) For purposes of this subsection, the Secretary shall collect and publish in the Federal Register data
p.000309: comparing the availability and need of maternity care health services in health professional shortage areas
p.000309: and in areas within such health professional short- age areas.
...

p.000317: relationships and development opportunities, including by—
p.000317: (A) establishing appropriate professional relationships between the Corps member involved and the health profes-
p.000317: sions community of the geographic area with respect to which the member is assigned;
p.000317: (B) establishing professional development, training, and mentorship linkages between the Corps member
p.000317: in- volved and the larger health professions community, in- cluding through distance learning, direct
p.000317: mentorship, and
p.000317: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000319: PUBLIC HEALTH SERVICE ACT
p.000319: Sec. 336
p.000319:
p.000319: development and implementation of training modules de- signed to meet the educational needs of offsite Corps mem-
p.000319: bers;
p.000319: (C) establishing professional networks among Corps members; or
p.000319: (D) engaging in other professional development, mentorship, and training activities for Corps
p.000319: members, at the discretion of the Secretary.
p.000319: (2) ASSISTANCE IN ESTABLISHING PROFESSIONAL RELATION- SHIPS.—In providing such assistance under paragraph
p.000319: (1), the Secretary shall focus on establishing relationships with hos- pitals, with academic medical
p.000319: centers and health professions schools, with area health education centers under section 751, with health
p.000319: education and training centers under section 752, and with border health education and training centers
p.000319: under such section 752. Such assistance shall include assistance in obtaining faculty appointments at health
p.000319: professions schools.
p.000319: (3) SUPPLEMENT NOT SUPPLANT.—Such efforts under this subsection shall supplement, not supplant, non-government
p.000319: ef- forts by professional health provider societies to establish and maintain professional relationships and
p.000319: development opportu- nities.
p.000319: (e) TEMPORARY RELIEF FROM CORPS DUTIES.—
p.000319: (1) IN GENERAL.—The Secretary shall, subject to paragraph (4), provide assistance to Corps members in
p.000319: establishing ar- rangements through which Corps members may, as appro- priate, be provided temporary relief
p.000319: from duties in the Corps in order to pursue continuing education in the health profes- sions, to
p.000319: participate in exchange programs with teaching cen- ters, to attend professional conferences, or to pursue
p.000319: other in- terests, including vacations.
p.000319: (2) ASSUMPTION OF DUTIES OF MEMBER.—
p.000319: (A) Temporary relief under paragraph (1) may be pro- vided only if the duties of the Corps member involved are assumed
p.000319: by another health professional. With respect to such temporary relief, the duties may be assumed
p.000319: by Corps members or by health professionals who are not Corps members, if the Secretary approves
p.000319: the profes- sionals for such purpose. Any health professional so ap- proved by the Secretary shall,
p.000319: during the period of pro- viding such temporary relief, be deemed to be a Corps member for purposes of
p.000319: section 224 (including for purposes of the remedy described in such section), section 333(f) 40, and section
p.000319: 335(e).
p.000319: (B) In carrying out paragraph (1), the Secretary shall provide for the formation and continued existence
p.000319: of a group of health professionals to provide temporary relief under such paragraph.
p.000319: (3) RECRUITMENT FROM GENERAL HEALTH PROFESSIONS COMMUNITY.—In carrying out paragraph (1), the
p.000319: Secretary shall—
p.000319:
p.000319:
p.000319:
p.000319:
p.000319: January 30, 2020
p.000319: 40 So in law. As a result of the amendments made by section 103(b) of Public Law 101–597 (104 Stat.
p.000319: 3015), there is no subsection (f) in section 333. (Subsection (e) of section 333, like sections 224 and
p.000319: 335(e), establishes a right for Corps members.)
p.000319: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000319:
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p.000329: primary health services in a health professional shortage area (des- ignated under section 332) to which such
p.000329: individual is assigned by the Secretary as a member of the Corps or released under section 338D;
p.000329: (2) a provision permitting the Secretary to extend for such longer additional periods, as the individual may
p.000329: agree to, the period of obligated service agreed to by the individual under paragraph (1)(B)(iv),
p.000329: including extensions resulting in an ag- gregate period of obligated service in excess of 4 years;
p.000329: (3) a provision that any financial obligation of the United States arising out of a contract entered into
p.000329: under this subpart and any obligation of the individual that is conditioned there- on, is contingent on
p.000329: funds being appropriated for loan repay- ments under this subpart and to carry out the purposes of sec- tions 331
p.000329: through 335 and sections 337 and 338;
p.000329: (4) a statement of the damages to which the United States is entitled, under section 338E for the individual’s
p.000329: breach of the contract; and
p.000329: (5) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with
p.000329: this sub- part.
p.000329: (g) PAYMENTS.—
p.000329: (1) IN GENERAL.—A loan repayment provided for an indi- vidual under a written contract under the Loan
p.000329: Repayment Program shall consist of payment, in accordance with para- graph (2), on behalf of the individual of
p.000329: the principal, interest, and related expenses on government and commercial loans re- ceived by the individual regarding
p.000329: the undergraduate or grad- uate education of the individual (or both), which loans were made for—
p.000329: (A) tuition expenses;
p.000329: (B) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred
p.000329: by the individual; or
p.000329: (C) reasonable living expenses as determined by the Secretary.
p.000329: (2) PAYMENTS FOR YEARS SERVED.—
p.000329: (A) IN GENERAL.—For each year of obligated service that an individual contracts to serve under subsection
p.000329: (f) the Secretary may pay up to $50,000, plus, beginning with fiscal year 2012, an amount determined by the
p.000329: Secretary on an annual basis to reflect inflation, on behalf of the in- dividual for loans described in paragraph (1).
p.000329: In making a determination of the amount to pay for a year of such serv- ice by an individual, the Secretary shall
p.000329: consider the ex- tent to which each such determination—
p.000329: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000329:
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p.000329: Sec. 338C PUBLIC HEALTH SERVICE ACT 330
p.000329:
p.000329: (i) affects the ability of the Secretary to maximize the number of contracts that can be provided under the
p.000329: Loan Repayment Program from the amounts ap- propriated for such contracts;
p.000329: (ii) provides an incentive to serve in health profes- sional shortage areas with the greatest such short- ages;
p.000329: and
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p.000329: percent of the total amount of loan repayments made for the taxable year involved; and
p.000329: (B) may make such additional payments as the Sec- retary determines to be appropriate with respect to
p.000329: such purpose.
p.000329: (4) PAYMENT SCHEDULE.—The Secretary may enter into an agreement with the holder of any loan for which payments are made
p.000329: under the Loan Repayment Program to establish a schedule for the making of such payments.
p.000329: (h) EMPLOYMENT CEILING.—Notwithstanding any other provi- sion of law, individuals who have entered into
p.000329: written contracts with the Secretary under this section, while undergoing academic or other training, shall
p.000329: not be counted against any employment ceiling affecting the Department.
p.000329:
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p.000329: January 30, 2020
p.000329:
p.000329: OBLIGATED SERVICE
p.000329: SEC. 338C. ø254m¿ (a) SERVICE IN FULL-TIME CLINICAL PRAC-
p.000329: TICE.—Except as provided in section 338D, each individual who has entered into a written contract with the
p.000329: Secretary under section 338A or 338B shall provide service in the full-time clinical practice of such individual’s
p.000329: profession as a member of the Corps for the pe- riod of obligated service provided in such contract. The
p.000329: Secretary may treat teaching as clinical practice for up to 20 percent of such period of obligated service.
p.000329: Notwithstanding the preceding sen- tence, with respect to a member of the Corps participating in the
p.000329: teaching health centers graduate medical education program under section 340H, for the purpose of calculating time
p.000329: spent in full-time clinical practice under this section, up to 50 percent of time spent
p.000329: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000329:
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p.000331: 331
p.000331: PUBLIC HEALTH SERVICE ACT
p.000331: Sec. 338C
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p.000331: January 30, 2020
p.000331: teaching by such member may be counted toward his or her service obligation.
p.000331: (b)(1) If an individual is required under subsection (a) to pro- vide service as specified in
p.000331: section 338A(f)(1)(B)(v) or 338B(f)(1)(B)(iv) (hereinafter in this subsection referred to as ‘‘obli- gated
p.000331: service’’), the Secretary shall, not later than ninety days be- fore the date described in paragraph
p.000331: (5), determine if the indi- vidual shall provide such service—
...

p.000339: October 1, 1984), an amount determined under section 338E(b), except that in ap- plying the formula
p.000339: contained in such section ‘‘’’ shall be the sum of the amount of the grant made under subsection (a)
p.000339: to such individual and the interest on such amount which would be payable if at the time it was paid it was a
p.000339: loan bearing in- terest at the maximum legal prevailing rate, ‘‘t’’ shall be the number of months that
p.000339: such individual agreed to practice his profession under agreement, and ‘‘s’’ shall be the number of
p.000339: months that such individual practices his profession in accord- ance with such agreement; and
p.000339: (2) in the case of an individual who has received a loan under this section, the full amount of the
p.000339: principal and interest owed by such individual under this section.
p.000339: SEC. 338H. ø254q¿ AUTHORIZATION OF APPROPRIATIONS.
p.000339: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section 43, there is authorized to be
p.000339: appropriated, out of any funds in the Treasury not otherwise appropriated, the following:
p.000339: (1) For fiscal year 2010, $320,461,632.
p.000339: (2) For fiscal year 2011, $414,095,394.
p.000339: (3) For fiscal year 2012, $535,087,442.
p.000339: (4) For fiscal year 2013, $691,431,432.
p.000339: (5) For fiscal year 2014, $893,456,433.
p.000339: (6) For fiscal year 2015, $1,154,510,336.
p.000339: (7) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for the preceding fiscal
p.000339: year adjusted by the product of—
p.000339: (A) one plus the average percentage increase in the costs of health professions education during the prior
p.000339: fiscal year; and
p.000339: (B) one plus the average percentage change in the number of individuals residing in health professions short-
p.000339: age areas designated under section 333 during the prior fiscal year, relative to the number of
p.000339: individuals residing in such areas during the previous fiscal year.
p.000339: (b) SCHOLARSHIPS FOR NEW PARTICIPANTS.—Of the amounts appropriated under subsection (a) for a fiscal
p.000339: year, the Secretary shall obligate not less than 10 percent for the purpose of providing contracts for—
p.000339: (1) scholarships under this subpart to individuals who have not previously received such scholarships; or
p.000339: (2) scholarships or loan repayments under the Loan Re- payment Program under section 338B to individuals
p.000339: from dis- advantaged backgrounds.
p.000339:
p.000339:
p.000339:
p.000339:
p.000339: January 30, 2020
p.000339: 43 The reference to ‘‘this section’’ in section 338H(a) probably should be a reference to ‘‘this
p.000339: subpart’’.
p.000339: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000339:
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p.000339: Sec. 338I PUBLIC HEALTH SERVICE ACT 340
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p.000343: January 30, 2020
p.000343: Guam, American Samoa, Palau, the Marshall Islands, and the Commonwealth of the Northern Mariana Islands.
p.000343: (i) AUTHORIZATION OF APPROPRIATIONS.—
p.000343: (1) IN GENERAL.—For the purpose of making grants under subsection (a), there are authorized to be
p.000343: appropriated
p.000343: $12,000,000 for fiscal year 2008, and such sums as may be nec- essary for each of fiscal years 2009 through 2012.
p.000343: (2) AVAILABILITY.—Amounts appropriated under paragraph
p.000343: (1) shall remain available until expended.
p.000343: (j) PUBLIC HEALTH LOAN REPAYMENT.—
p.000343: (1) IN GENERAL.—The Secretary may award grants to States for the purpose of assisting such States
p.000343: in operating loan repayment programs under which such States enter into contracts to repay all or part of the
p.000343: eligible loans borrowed by, or on behalf of, individuals who agree to serve in State, local, or tribal
p.000343: health departments that serve health professional shortage areas or other areas at risk of a public
p.000343: health emer- gency, as designated by the Secretary.
p.000343: (2) LOANS ELIGIBLE FOR REPAYMENT.—To be eligible for re- payment under this subsection, a loan shall be a
p.000343: loan made, insured, or guaranteed by the Federal Government that is bor- rowed by, or on behalf of, an
p.000343: individual to pay the cost of at- tendance for a program of education leading to a degree appro- priate for
p.000343: serving in a State, local, or tribal health department as determined by the Secretary and the chief executive
p.000343: officer of the State in which the grant is administered, at an institu- tion of higher education (as defined in section
p.000343: 102 of the High- er Education Act of 1965), including principal, interest, and re- lated expenses on such loan.
p.000343: (3) APPLICABILITY OF EXISTING REQUIREMENTS.—With re- spect to awards made under paragraph (1)—
p.000343: (A) the requirements of subsections (b), (f), and (g) shall apply to such awards; and
p.000343: (B) the requirements of subsection (c) shall apply to such awards except that with respect to paragraph
p.000343: (1) of such subsection, the State involved may assign an indi- vidual only to public and nonprofit
p.000343: private entities that serve health professional shortage areas or areas at risk of a public health emergency, as
p.000343: determined by the Sec- retary.
p.000343: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000343: sums as may be necessary for each of fiscal years 2007 through 2010.
p.000343: SEC. 338J. ø254r¿ GRANTS TO STATE OFFICES OF RURAL HEALTH.
p.000343: (a) IN GENERAL.—The Secretary, acting through the Director of the Federal Office of Rural Health Policy (established
p.000343: under section 711 of the Social Security Act), shall make grants to each State Of- fice of Rural Health for the
p.000343: purpose of improving health care in rural areas.
p.000343: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000343: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless the
p.000343: State of- fice of rural health involved agrees, with respect to the costs
p.000343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000343:
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p.000345: (A) SUPERVISION OF INDIVIDUALS.—Nothing in this sec- tion shall be construed to require or imply that a physician
p.000345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000347: 347
p.000347: PUBLIC HEALTH SERVICE ACT
p.000347: Sec. 338L
p.000347:
p.000347: or other health professional licensed to prescribe drugs must supervise an individual receiving assistance
p.000347: under the demonstration project under this section, with respect to such project.
p.000347: (B) LICENSURE OF HEALTH PROFESSIONALS.—Nothing in this section shall be construed to supersede State
p.000347: law regarding licensure of health professionals.
p.000347: (d) DESIGNATIONS.—The demonstration project described in this section, and any providers who are
p.000347: selected to participate in such project, shall not be considered by the Secretary in the des- ignation
p.000347: of a health professional shortage area under section 332 during fiscal years 2002 through 2004.
p.000347: (e) RULE OF CONSTRUCTION.—This section shall not be con- strued to require any State to participate in
p.000347: the project described in this section.
p.000347: (f) REPORT.—
p.000347: (1) IN GENERAL.—The Secretary shall evaluate the partici- pation of individuals in the demonstration projects
p.000347: under this section and prepare and submit a report containing the infor- mation described in paragraph (2)
p.000347: to—
p.000347: (A) the Committee on Health, Education, Labor, and Pensions of the Senate;
p.000347: (B) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria-
p.000347: tions of the Senate;
p.000347: (C) the Committee on Energy and Commerce of the House of Representatives; and
p.000347: (D) the Subcommittee on Labor, Health and Human Services, and Education of the Committee on Appropria-
p.000347: tions of the House of Representatives.
p.000347: (2) CONTENT.—The report described in paragraph (1) shall detail—
p.000347: (A) the manner in which the demonstration project de- scribed in this section has affected access to primary
p.000347: care services, patient satisfaction, quality of care, and health care services provided for traditionally
p.000347: underserved popu- lations;
p.000347: (B) how the participation of chiropractic doctors and pharmacists in the Loan Repayment Program might affect the
p.000347: designation of health professional shortage areas; and
p.000347: (C) whether adding chiropractic doctors and phar- macists as permanent members of the National
p.000347: Health Service Corps would be feasible and would enhance the ef- fectiveness of the National Health Service Corps.
p.000347: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000347: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section, such sums as may be
p.000347: necessary for fiscal years 2002 through 2004.
p.000347: (2) FISCAL YEAR 2005 44.—If the Secretary determines and certifies to Congress by not later than
p.000347: September 30, 2004,
p.000347:
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p.000347: January 30, 2020
p.000347: 44 So in law. The figure in the heading for paragraph (2) was erroneously enacted so that ‘‘2005’’
p.000347: appears in full figures. However, the version represented here in the pdf reflects this
p.000347: Continued
p.000347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: (9) Entities receiving assistance under title XXVI (relating to services with respect to acquired immune
p.000369: deficiency syn- drome).
p.000369: (10) Non-Federal entities authorized under the Indian Self- Determination Act.
p.000369:
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p.000369: January 30, 2020
p.000369: 53 The reference to section 317F is so in law. See section 2502(b) of Public Law 106–310 (114 Stat. 1163). Section 317E
p.000369: relates to tuberculosis, not section 317F.
p.000369: 54 See footnote for section 217(a).
p.000369: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: Sec. 340E PUBLIC HEALTH SERVICE ACT 370
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p.000369: January 30, 2020
p.000369:
p.000369: Subpart IX—Support of Graduate Medical Education Programs in Children’s Hospitals
p.000369: SEC. 340E. ø256e¿ PROGRAM OF PAYMENTS TO CHILDREN’S HOS- PITALS THAT OPERATE GRADUATE MEDICAL EDUCATION
p.000369: PROGRAMS.
p.000369: (a) PAYMENTS.—The Secretary shall make two payments under this section to each children’s hospital for each of fiscal
p.000369: years 2000 through 2005, each of fiscal years 2007 through 2011, each of fiscal years 2014 through 2018, and each
p.000369: of fiscal years 2019 through 2023, one for the direct expenses and the other for indirect ex- penses
p.000369: associated with operating approved graduate medical resi- dency training programs. The Secretary shall
p.000369: promulgate regula- tions pursuant to the rulemaking requirements of title 5, United States Code, which
p.000369: shall govern payments made under this sub- part.
p.000369: (b) AMOUNT OF PAYMENTS.—
p.000369: (1) IN GENERAL.—Subject to paragraphs (2) and (3), the amounts payable under this section to a children’s
p.000369: hospital for an approved graduate medical residency training program for a fiscal year are each of the following
p.000369: amounts:
p.000369: (A) DIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (c) for direct expenses associated
p.000369: with operating approved graduate medical residency train- ing programs.
p.000369: (B) INDIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (d) for indirect expenses associ-
p.000369: ated with the treatment of more severely ill patients and the additional costs relating to teaching
p.000369: residents in such programs.
p.000369: (2) CAPPED AMOUNT.—
p.000369: (A) IN GENERAL.—The total of the payments made to children’s hospitals under paragraph (1)(A) or
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p.000371: of the hospital or within the borders of the State in which the hospital is located. Such numbers shall
p.000371: be disaggregated with respect to residents who completed residencies in general pediatrics or internal medicine/
p.000371: pediatrics, subspecialty residencies, and dental residencies.
p.000371: (C) RESIDENTS.—The residents described in this sub- paragraph are those who—
p.000371: (i) are in full-time equivalent resident training po- sitions in any training program sponsored by the hos- pital; or
p.000371: (ii) are in a training program sponsored by an en- tity other than the hospital, but who spend more than 75 percent of
p.000371: their training time at the hospital.
p.000371: (D) REPORT TO CONGRESS.—Not later than the end of fiscal year 2018, and the end of fiscal year 2022,
p.000371: the Sec- retary, acting through the Administrator of the Health Re- sources and Services Administration, shall submit
p.000371: a report to the Congress—
p.000371: (i) summarizing the information submitted in re- ports to the Secretary under subparagraph (B);
p.000371: (ii) describing the results of the program carried out under this section; and
p.000371: (iii) making recommendations for improvements to the program.
p.000371: (c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDU-
p.000371: CATION.—
p.000371: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for direct
p.000371: graduate expenses relating to approved graduate medical residency training programs for a fiscal year is
p.000371: equal to the product of—
p.000371: (A) the updated per resident amount for direct grad- uate medical education, as determined under
p.000371: paragraph (2); and
p.000371: (B) the average number of full-time equivalent resi- dents in the hospital’s graduate approved medical
p.000371: resi- dency training programs (as determined under section 1886(h)(4) of the Social Security Act during the
p.000371: fiscal year.
p.000371: (2) UPDATED PER RESIDENT AMOUNT FOR DIRECT GRADUATE MEDICAL EDUCATION.—The updated per resident amount for di-
p.000371: rect graduate medical education for a hospital for a fiscal year is an amount determined as follows:
p.000371: (A) DETERMINATION OF HOSPITAL SINGLE PER RESIDENT AMOUNT.—The Secretary shall compute for each hospital
p.000371: operating an approved graduate medical education pro- gram (regardless of whether or not it is a
p.000371: children’s hos- pital) a single per resident amount equal to the average (weighted by number of full-time
p.000371: equivalent residents) of the primary care per resident amount and the non-primary care per resident amount
p.000371: computed under section
p.000371: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000373: PUBLIC HEALTH SERVICE ACT
p.000373: Sec. 340E
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p.000373: January 30, 2020
p.000373: 1886(h)(2) of the Social Security Act for cost reporting peri- ods ending during fiscal year 1997.
p.000373: (B) DETERMINATION OF WAGE AND NON-WAGE-RELATED PROPORTION OF THE SINGLE PER RESIDENT AMOUNT.—The
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p.000373: Security Act for discharges occurring during fiscal year 1999 for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (D) DETERMINATION OF NATIONAL AVERAGE.—The Sec- retary shall compute a national average per resident
p.000373: amount equal to the average of the standardized per resi- dent amounts computed under subparagraph (C) for such
p.000373: hospitals, with the amount for each hospital weighted by the average number of full-time equivalent
p.000373: residents at such hospital.
p.000373: (E) APPLICATION TO INDIVIDUAL HOSPITALS.—The Sec- retary shall compute for each such hospital that is a
p.000373: chil- dren’s hospital a per resident amount—
p.000373: (i) by dividing the national average per resident amount computed under subparagraph (D) into a
p.000373: wage-related portion and a non-wage-related portion by applying the proportion determined under subpara- graph
p.000373: (B);
p.000373: (ii) by multiplying the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social Security
p.000373: Act for discharges occurring during the pre- ceding fiscal year for the hospital’s area; and
p.000373: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000373: (F) UPDATING RATE.—The Secretary shall update such per resident amount for each such children’s hospital by the
p.000373: estimated percentage increase in the consumer price index for all urban consumers during the period beginning
p.000373: October 1997 and ending with the midpoint of the Federal fiscal year for which payments are made.
p.000373: (d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
p.000373: (1) IN GENERAL.—The amount determined under this sub- section for payments to a children’s hospital for
p.000373: indirect ex- penses associated with the treatment of more severely ill pa- tients and the additional
p.000373: costs associated with the teaching of residents for a fiscal year is equal to an amount determined
p.000373: appropriate by the Secretary.
p.000373: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000373: Sec. 340E PUBLIC HEALTH SERVICE ACT 374
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p.000373: January 30, 2020
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p.000373: (2) FACTORS.—In determining the amount under para- graph (1), the Secretary shall—
p.000373: (A) take into account variations in case mix among children’s hospitals and the ratio of the number of
p.000373: full- time equivalent residents in the hospitals’ approved grad- uate medical residency training programs to
p.000373: beds (but ex- cluding beds or bassinets assigned to healthy newborn in- fants); and
p.000373: (B) assure that the aggregate of the payments for indi- rect expenses associated with the treatment of more se-
p.000373: verely ill patients and the additional costs related to the teaching of residents under this section in a
p.000373: fiscal year are equal to the amount appropriated for such expenses for the fiscal year involved under subsection
p.000373: (f)(2).
p.000373: (e) MAKING OF PAYMENTS.—
p.000373: (1) INTERIM PAYMENTS.—The Secretary shall determine, before the beginning of each fiscal year involved for which
p.000373: pay- ments may be made for a hospital under this section, the amounts of the payments for direct graduate
p.000373: medical education and indirect medical education for such fiscal year and shall (subject to paragraph (2))
p.000373: make the payments of such amounts in 12 equal interim installments during such period. Such in- terim
p.000373: payments to each individual hospital shall be based on the number of residents reported in the
p.000373: hospital’s most re- cently filed Medicare cost report prior to the application date for the Federal
p.000373: fiscal year for which the interim payment amounts are established. In the case of a hospital that does not report
p.000373: residents on a Medicare cost report, such interim pay- ments shall be based on the number of residents
p.000373: trained dur- ing the hospital’s most recently completed Medicare cost report filing period.
p.000373: (2) WITHHOLDING.—The Secretary shall withhold up to 25 percent from each interim installment for direct
p.000373: and indirect graduate medical education paid under paragraph (1) as nec- essary to ensure a hospital will not
p.000373: be overpaid on an interim basis.
p.000373: (3) RECONCILIATION.—Prior to the end of each fiscal year, the Secretary shall determine any changes to
p.000373: the number of residents reported by a hospital in the application of the hos- pital for the current fiscal
p.000373: year to determine the final amount payable to the hospital for the current fiscal year for both di- rect
p.000373: expense and indirect expense amounts. Based on such de- termination, the Secretary shall recoup any
p.000373: overpayments made and pay any balance due to the extent possible. The final amount so determined shall be considered a
p.000373: final intermediary determination for the purposes of section 1878 of the Social Se- curity Act and shall be
p.000373: subject to administrative and judicial review under that section in the same manner as the amount of
p.000373: payment under section 1186(d) of such Act is subject to re- view under such section.
p.000373: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000373: (1) DIRECT GRADUATE MEDICAL EDUCATION.—
p.000373: (A) IN GENERAL.—There are hereby authorized to be appropriated, out of any money in the Treasury not other-
p.000373: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000375: PUBLIC HEALTH SERVICE ACT
p.000375: Sec. 340E
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p.000375: January 30, 2020
p.000375: wise appropriated, for payments under subsection (b)(1)(A)—
p.000375: (i) for fiscal year 2000, $90,000,000;
p.000375: (ii) for fiscal year 2001, $95,000,000;
p.000375: (iii) for each of the fiscal years 2002 through 2005, such sums as may be necessary;
p.000375: (iv) for each of fiscal years 2007 through 2011,
p.000375: $110,000,000;
p.000375: (v) for each of fiscal years 2014 through 2018,
p.000375: $100,000,000; and
p.000375: (vi) for each of fiscal years 2019 through 2023,
p.000375: $105,000,000.
p.000375: (B) CARRYOVER OF EXCESS.—The amounts appro- priated under subparagraph (A) for fiscal year 2000 shall
p.000375: remain available for obligation through the end of fiscal year 2001.
p.000375: (2) INDIRECT MEDICAL EDUCATION.—There are hereby au- thorized to be appropriated, out of any money in the
p.000375: Treasury not otherwise appropriated, for payments under subsection (b)(1)(B)—
p.000375: (A) for fiscal year 2000, $190,000,000; (B) for fiscal year 2001, $190,000,000;
p.000375: (C) for each of the fiscal years 2002 through 2005, such sums as may be necessary;
p.000375: (D) for each of fiscal years 2007 through 2011,
p.000375: $220,000,000;
p.000375: (E) for each of fiscal years 2014 through 2018,
p.000375: $200,000,000; and
p.000375: (F) for each of fiscal years 2019 through 2023,
p.000375: $220,000,000.
p.000375: (g) DEFINITIONS.—In this section:
p.000375: (1) APPROVED GRADUATE MEDICAL RESIDENCY TRAINING PROGRAM.—The term ‘‘approved graduate medical
p.000375: residency training program’’ has the meaning given the term ‘‘approved medical residency training program’’ in
p.000375: section 1886(h)(5)(A) of the Social Security Act.
p.000375: (2) CHILDREN’S HOSPITAL.—The term ‘‘children’s hospital’’ means a hospital with a Medicare payment
p.000375: agreement and which is excluded from the Medicare inpatient prospective pay- ment system pursuant to section
p.000375: 1886(d)(1)(B)(iii) of the Social Security Act and its accompanying regulations.
p.000375: (3) DIRECT GRADUATE MEDICAL EDUCATION COSTS.—The term ‘‘direct graduate medical education costs’’ has
p.000375: the mean- ing given such term in section 1886(h)(5)(C) of the Social Secu- rity Act.
p.000375: (h) ADDITIONAL PROVISIONS.—
p.000375: (1) IN GENERAL.—The Secretary is authorized to make available up to 25 percent of the total amounts in
p.000375: excess of
p.000375: $245,000,000 appropriated under paragraphs (1) and (2) of sub- section (f), but not to exceed $7,000,000, for
p.000375: payments to hos- pitals qualified as described in paragraph (2), for the direct and indirect expenses
p.000375: associated with operating approved grad- uate medical residency training programs, as described in sub- section (a).
p.000375: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000375: Sec. 340E PUBLIC HEALTH SERVICE ACT 376
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p.000375: (2) QUALIFIED HOSPITALS.—
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p.000377: January 30, 2020
p.000377:
p.000377: (A) the expansion or establishment of a community- based dental facility, free-standing dental clinic,
p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
p.000377: (2) ASSURANCES.—The application shall include assurances that the State will meet the requirements of subsection (d)
p.000377: and that the State possesses sufficient infrastructure to manage the activities to be funded through the
p.000377: grant and to evaluate and report on the outcomes resulting from such activities.
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p.000379: containing data relating to whether grants pro- vided under this section have increased access to dental services
p.000379: in designated dental health professional shortage areas.
p.000379: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000379: $13,903,000 for each of fiscal years 2019 through 2023.
p.000379: SEC. 340G–1. ø256g–1¿ DEMONSTRATION PROGRAM.
p.000379: (a) IN GENERAL.—
p.000379: (1) AUTHORIZATION.—The Secretary is authorized to award grants to 15 eligible entities to enable such entities to
p.000379: establish a demonstration program to establish training programs to train, or to employ, alternative dental
p.000379: health care providers in order to increase access to dental health care services in rural and other underserved
p.000379: communities.
p.000379: (2) DEFINITION.—The term ‘‘alternative dental health care providers’’ includes community dental health
p.000379: coordinators, ad- vance practice dental hygienists, independent dental hygien- ists, supervised dental
p.000379: hygienists, primary care physicians, dental therapists, dental health aides, and any other health
p.000379: professional that the Secretary determines appropriate.
p.000379: (b) TIMEFRAME.—The demonstration projects funded under this section shall begin not later than 2 years after
p.000379: the date of enact- ment of this section, and shall conclude not later than 7 years after such date of enactment.
p.000379: (c) ELIGIBLE ENTITIES.—To be eligible to receive a grant under subsection (a), an entity shall—
p.000379: (1) be—
p.000379: (A) an institution of higher education, including a com- munity college;
p.000379: (B) a public-private partnership;
p.000379: (C) a federally qualified health center;
p.000379: (D) an Indian Health Service facility or a tribe or trib- al organization (as such terms are defined in section
p.000379: 4 of the Indian Self-Determination and Education Assistance Act);
p.000379: (E) a State or county public health clinic, a health fa- cility operated by an Indian tribe or tribal organization, or
p.000379: urban Indian organization providing dental services; or
p.000379: (F) a public hospital or health system;
p.000379: (2) be within a program accredited by the Commission on Dental Accreditation or within a dental
p.000379: education program in an accredited institution; and
p.000379: (3) shall submit an application to the Secretary at such time, in such manner, and containing such information
p.000379: as the Secretary may require.
p.000379: (d) ADMINISTRATIVE PROVISIONS.—
p.000379: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000379: Sec. 340H PUBLIC HEALTH SERVICE ACT 380
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p.000379: (1) AMOUNT OF GRANT.—Each grant under this section shall be in an amount that is not less than $4,000,000 for
p.000379: the 5-year period during which the demonstration project being conducted.
p.000379: (2) DISBURSEMENT OF FUNDS.—
p.000379: (A) PRELIMINARY DISBURSEMENTS.—Beginning 1 year after the enactment of this section, the Secretary may dis- perse
p.000379: to any entity receiving a grant under this section not more than 20 percent of the total funding awarded to such entity
p.000379: under such grant, for the purpose of enabling the entity to plan the demonstration project to be
p.000379: conducted under such grant.
p.000379: (B) SUBSEQUENT DISBURSEMENTS.—The remaining amount of grant funds not dispersed under subparagraph
p.000379: (A) shall be dispersed such that not less than 15 percent of such remaining amount is dispersed each
p.000379: subsequent year.
p.000379: (e) COMPLIANCE WITH STATE REQUIREMENTS.—Each entity re- ceiving a grant under this section shall certify that it
p.000379: is in compli- ance with all applicable State licensing requirements.
p.000379: (f) EVALUATION.—The Secretary shall contract with the Direc- tor of the Institute of Medicine to conduct
p.000379: a study of the dem- onstration programs conducted under this section that shall pro- vide analysis, based
p.000379: upon quantitative and qualitative data, re- garding access to dental health care in the United States.
p.000379: (g) CLARIFICATION REGARDING DENTAL HEALTH AIDE PRO- GRAM.—Nothing in this section shall prohibit
p.000379: a dental health aide training program approved by the Indian Health Service from being eligible for a grant
p.000379: under this section.
p.000379: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000379: carry out this section.
p.000379:
p.000379: Subpart XI—Support of Graduate Medical Education in Qualified Teaching Health Centers
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p.000379: January 30, 2020
p.000379: SEC. 340H. ø256h¿ PROGRAM OF PAYMENTS TO TEACHING HEALTH CENTERS THAT OPERATE GRADUATE MEDICAL EDU-
p.000379: CATION PROGRAMS.
p.000379: (a) PAYMENTS.—
p.000379: (1) IN GENERAL.—Subject to subsection (h)(2), the Sec- retary shall make payments under this section for
p.000379: direct ex- penses and indirect expenses to qualified teaching health cen- ters that are listed as
p.000379: sponsoring institutions by the relevant accrediting body for, as appropriate—
p.000379: (A) maintenance of filled positions at existing ap- proved graduate medical residency training programs;
p.000379: (B) expansion of existing approved graduate medical residency training programs; and
p.000379: (C) establishment of new approved graduate medical residency training programs.
p.000379: (2) PER RESIDENT AMOUNT.—In making payments under paragraph (1), the Secretary shall consider the cost of
p.000379: training residents at teaching health centers and the implications of the
p.000379: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000381: PUBLIC HEALTH SERVICE ACT
p.000381: Sec. 340H
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p.000381: (1) IN GENERAL.—Subject to paragraph (2), the amounts payable under this section to qualified teaching health
p.000381: centers for an approved graduate medical residency training program for a fiscal year are each of the following
p.000381: amounts:
p.000381: (A) DIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (c) for direct expenses associated
p.000381: with sponsoring approved graduate medical residency training programs.
p.000381: (B) INDIRECT EXPENSE AMOUNT.—The amount deter- mined under subsection (d) for indirect expenses associ-
p.000381: ated with the additional costs relating to teaching resi- dents in such programs.
p.000381: (2) CAPPED AMOUNT.—
p.000381: (A) IN GENERAL.—The total of the payments made to qualified teaching health centers under paragraph
p.000381: (1)(A) or paragraph (1)(B) in a fiscal year shall not exceed the amount of funds appropriated under
p.000381: subsection (g) for such payments for that fiscal year.
p.000381: (B) LIMITATION.—The Secretary shall limit the funding of full-time equivalent residents in order to ensure the di-
p.000381: rect and indirect payments as determined under sub- section (c) and (d) do not exceed the total amount of
p.000381: funds appropriated in a fiscal year under subsection (g).
p.000381: (c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE MEDICAL EDU-
p.000381: CATION.—
p.000381: (1) IN GENERAL.—The amount determined under this sub- section for payments to qualified teaching health centers
p.000381: for di- rect graduate expenses relating to approved graduate medical residency training programs for a
p.000381: fiscal year is equal to the product of—
p.000381: (A) the updated national per resident amount for di- rect graduate medical education, as determined
p.000381: under paragraph (2); and
p.000381: (B) the average number of full-time equivalent resi- dents in the teaching health center’s graduate
p.000381: approved medical residency training programs as determined under section 1886(h)(4) of the Social Security
p.000381: Act (without re- gard to the limitation under subparagraph (F) of such sec- tion) during the fiscal year.
p.000381: (2) UPDATED NATIONAL PER RESIDENT AMOUNT FOR DIRECT GRADUATE MEDICAL EDUCATION.—The updated per
p.000381: resident amount for direct graduate medical education for a qualified
p.000381: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000381: Sec. 340H PUBLIC HEALTH SERVICE ACT 382
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p.000381: January 30, 2020
p.000381:
p.000381: teaching health center for a fiscal year is an amount deter- mined as follows:
p.000381: (A) DETERMINATION OF QUALIFIED TEACHING HEALTH CENTER PER RESIDENT AMOUNT.—The Secretary shall com- pute
p.000381: for each individual qualified teaching health center a per resident amount—
p.000381: (i) by dividing the national average per resident amount computed under section 340E(c)(2)(D) into a
p.000381: wage-related portion and a non-wage related portion by applying the proportion determined under subpara- graph
p.000381: (B);
p.000381: (ii) by multiplying the wage-related portion by the factor applied under section 1886(d)(3)(E) of the Social Security
p.000381: Act (but without application of section 4410 of the Balanced Budget Act of 1997 (42 U.S.C. 1395ww note)) during
p.000381: the preceding fiscal year for the teaching health center’s area; and
p.000381: (iii) by adding the non-wage-related portion to the amount computed under clause (ii).
p.000381: (B) UPDATING RATE.—The Secretary shall update such per resident amount for each such qualified teaching
p.000381: health center as determined appropriate by the Secretary.
p.000381: (d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL EDUCATION.—
p.000381: (1) IN GENERAL.—The amount determined under this sub- section for payments to qualified teaching health centers
p.000381: for in- direct expenses associated with the additional costs of teaching residents for a fiscal year is equal to
p.000381: an amount determined appropriate by the Secretary.
p.000381: (2) FACTORS.—In determining the amount under para- graph (1), the Secretary shall—
p.000381: (A) evaluate indirect training costs relative to sup- porting a primary care residency program in
p.000381: qualified teaching health centers; and
p.000381: (B) based on this evaluation, assure that the aggregate of the payments for indirect expenses under this
p.000381: section and the payments for direct graduate medical education as determined under subsection (c) in a fiscal year do
p.000381: not ex- ceed the amount appropriated for such expenses as deter- mined in subsection (g).
p.000381: (3) INTERIM PAYMENT.—Before the Secretary makes a pay- ment under this subsection pursuant to a determination of in-
p.000381: direct expenses under paragraph (1), the Secretary may pro- vide to qualified teaching health centers a
p.000381: payment, in addi- tion to any payment made under subsection (c), for expected indirect expenses associated
p.000381: with the additional costs of teach- ing residents for a fiscal year, based on an estimate by the Sec- retary.
p.000381: (e) CLARIFICATION REGARDING RELATIONSHIP TO OTHER PAY- MENTS FOR GRADUATE MEDICAL EDUCATION.—Payments
p.000381: under this section—
p.000381: (1) shall be in addition to any payments—
p.000381: (A) for the indirect costs of medical education under section 1886(d)(5)(B) of the Social Security Act;
p.000381: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000383: PUBLIC HEALTH SERVICE ACT
p.000383: Sec. 340H
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p.000383: (B) for direct graduate medical education costs under section 1886(h) of such Act; and
p.000383: (C) for direct costs of medical education under section 1886(k) of such Act;
p.000383: (2) shall not be taken into account in applying the limita- tion on the number of total full-time
p.000383: equivalent residents under subparagraphs (F) and (G) of section 1886(h)(4) of such Act and clauses (v),
p.000383: (vi)(I), and (vi)(II) of section 1886(d)(5)(B) of such Act for the portion of time that a resident
p.000383: rotates to a hospital; and
p.000383: (3) shall not include the time in which a resident is count- ed toward full-time equivalency by a hospital under
p.000383: paragraph
p.000383: (2) or under section 1886(d)(5)(B)(iv) of the Social Security Act, section 1886(h)(4)(E) of such Act, or section
p.000383: 340E of this Act.
p.000383: (f) RECONCILIATION.—The Secretary shall determine any changes to the number of residents reported
p.000383: by a teaching health center in the application of the teaching health center for the cur- rent fiscal year to
p.000383: determine the final amount payable to the teach- ing health center for the current fiscal year for both direct expense
p.000383: and indirect expense amounts. Based on such determination, the Secretary shall recoup any overpayments made to
p.000383: pay any balance due to the extent possible. The final amount so determined shall be considered a final
p.000383: intermediary determination for the purposes of section 1878 of the Social Security Act and shall be
p.000383: subject to administrative and judicial review under that section in the same manner as the amount of
p.000383: payment under section 1186(d) of such Act is subject to review under such section.
p.000383: (g) FUNDING.—
p.000383: (1) IN GENERAL.—To carry out this section, there are ap- propriated such sums as may be necessary, not
p.000383: to exceed
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p.000403: PUBLIC HEALTH SERVICE ACT
p.000403: Sec. 351A
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p.000403: (B) proper laboratory facilities to contain and dispose of such agents and toxins;
p.000403: (2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and
p.000403: toxins for use in domestic or international terrorism or for any other criminal purpose;
p.000403: (3) the establishment of procedures to protect the public safety in the event of a transfer or
p.000403: potential transfer of such an agent or toxin in violation of the safety procedures estab- lished under
p.000403: paragraph (1) or the safeguard and security meas- ures established under paragraph (2); and
p.000403: (4) appropriate availability of biological agents and toxins for research, education, and other legitimate
p.000403: purposes.
p.000403: (c) POSSESSION AND USE OF LISTED AGENTS AND TOXINS.—The Secretary shall by regulation provide for the
p.000403: establishment and en- forcement of standards and procedures governing the possession and use of listed
p.000403: agents and toxins, including the provisions de- scribed in paragraphs (1) through (4) of subsection (b),
p.000403: in order to protect the public health and safety.
p.000403: (d) REGISTRATION; IDENTIFICATION; DATABASE.—
p.000403: (1) REGISTRATION.—Regulations under subsections (b) and
p.000403: (c) shall require registration with the Secretary of the posses- sion, use, and transfer of listed agents and
p.000403: toxins, and shall in- clude provisions to ensure that persons seeking to register under such regulations
p.000403: have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in ac-
p.000403: cordance with subsection (e)(6).
p.000403: (2) IDENTIFICATION; DATABASE.—Regulations under sub- sections (b) and (c) shall require that
p.000403: registration include (if available to the person registering) information regarding the characterization of
p.000403: listed agents and toxins to facilitate their identification, including their source. The Secretary shall main-
p.000403: tain a national database that includes the names and locations of registered persons, the listed agents and toxins such
p.000403: persons are possessing, using, or transferring, and information regard- ing the characterization of such agents and
p.000403: toxins.
p.000403: (e) SAFEGUARD AND SECURITY REQUIREMENTS FOR REGISTERED PERSONS.—
p.000403: (1) IN GENERAL.—Regulations under subsections (b) and (c) shall include appropriate safeguard and security requirements
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p.000415: through (m), any reference made in any of such subsections to the standards estab- lished under subsection (f)
p.000415: ‘‘shall be considered a reference to the standards established under subsection (d) [of section 353], as in
p.000415: effect on December 31, 1988.’’.
p.000415: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000415: Sec. 353 PUBLIC HEALTH SERVICE ACT 416
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p.000415: meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examina-
p.000415: tions and procedures within the laboratory, which quali- fications shall take into consideration
p.000415: competency, train- ing, experience, job performance, and education and which qualifications shall, as appropriate,
p.000415: be different on the basis of the type of examinations and procedures being performed by the laboratory
p.000415: and the risks and con- sequences of erroneous results associated with such exami- nations and procedures,
p.000415: (D) to qualify under a proficiency testing program meeting the standards established by the Secretary under
p.000415: paragraph (3), and
p.000415: (E) to meet such other requirements as the Secretary determines necessary to assure consistent performance
p.000415: by such laboratories of accurate and reliable laboratory ex- aminations and procedures.
p.000415: (2) CONSIDERATIONS.—In developing the standards to be issued under paragraph (1), the Secretary shall,
p.000415: within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration—
p.000415: (A) the examinations and procedures performed and the methodologies employed,
p.000415: (B) the degree of independent judgment involved,
p.000415: (C) the amount of interpretation involved,
p.000415: (D) the difficulty of the calculations involved,
p.000415: (E) the calibration and quality control requirements of the instruments used,
p.000415: (F) the type of training required to operate the instru- ments used in the methodology, and
p.000415: (G) such other factors as the Secretary considers rel- evant.
p.000415: (3) PROFICIENCY TESTING PROGRAM.—
p.000415: (A) IN GENERAL.—The Secretary shall establish stand- ards for the proficiency testing programs for laboratories
p.000415: issued a certificate under this section which are conducted by the Secretary, conducted by an organization
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p.000429: radiologic standards and standards for other equipment and materials used in conjunction with such equipment;
p.000429: (C) a requirement that personnel who perform mam- mography—
p.000429: (i)(I) be licensed by a State to perform radiological procedures; or
p.000429: (II) be certified as qualified to perform radiological procedures by an organization described in paragraph
p.000429: (2)(A); and
p.000429: (ii) during the 2-year period beginning October 1, 1994, meet training standards for personnel who per-
p.000429: form mammography or meet experience requirements which shall at a minimum include 1 year of experience in the
p.000429: performance of mammography; and
p.000429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000429:
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p.000429: Sec. 354 PUBLIC HEALTH SERVICE ACT 430
p.000429:
p.000429: (iii) upon the expiration of such 2-year period meet minimum training standards for personnel who perform
p.000429: mammograms;
p.000429: (D) a requirement that mammograms be interpreted by a physician who is certified as qualified to interpret ra-
p.000429: diological procedures, including mammography—
p.000429: (i)(I) by a board described in paragraph (2)(B); or
p.000429: (II) by a program that complies with the stand- ards described in paragraph (2)(C); and
p.000429: (ii) who meets training and continuing medical education requirements as established by the Sec-
p.000429: retary;
p.000429: (E) a requirement that individuals who survey mam- mography facilities be medical physicists—
p.000429: (i) licensed or approved by a State to perform such surveys, reviews, or inspections for mammography fa-
p.000429: cilities;
p.000429: (ii) certified in diagnostic radiological physics or certified as qualified to perform such surveys by a
p.000429: board as described in paragraph (2)(D); or
p.000429: (iii) in the first 5 years after the date of the enact- ment of this section, who meet other criteria estab-
p.000429: lished by the Secretary which are comparable to the criteria described in clause (i) or (ii);
p.000429: (F) a requirement that a medical physicist who is qualified in mammography as described in subparagraph
p.000429: (E) survey mammography equipment and oversee quality assurance practices at each facility;
p.000429: (G) a requirement that—
p.000429: (i) a facility that performs any mammogram—
p.000429: (I) except as provided in subclause (II), main- tain the mammogram in the permanent medical records of the
p.000429: patient for a period of not less than 5 years, or not less than 10 years if no subsequent mammograms of such patient
p.000429: are performed at the facility, or longer if mandated by State law; and
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p.000429: (II) upon the request of or on behalf of the pa- tient, transfer the mammogram to a medical insti- tution, to a
p.000429: physician of the patient, or to the pa- tient directly; and
p.000429: (ii)(I) a facility must assure the preparation of a written report of the results of any mammography ex-
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p.000443: PUBLIC HEALTH SERVICE ACT
p.000443: Sec. 365
p.000443:
p.000443: rate of pay which is applicable to such employees for work per- formed within their regular scheduled tour
p.000443: of duty.
p.000443: (d)(1) The said extra compensation shall be paid to the United States by the owner, agent, consignee, operator, or
p.000443: master or other person in charge of any conveyance, for whom, at his request, serv- ices as described in this
p.000443: subsection (hereinafter referred to as over- time service) are performed. If such employees have been ordered
p.000443: to report for duty and have so reported, and the requested services are not performed by reason of circumstances beyond
p.000443: the control of the employees concerned, such extra compensation shall be paid on the same basis as though the
p.000443: overtime services had actually been performed during the period between the time the employees were ordered to
p.000443: report for duty and did so report, and the time they were notified that their services would not be required,
p.000443: and in any case as though their services had continued for not less than one hour. The Surgeon General
p.000443: with the approval of the Secretary of Health, Education, and Welfare may prescribe regulations requir- ing
p.000443: the owner, agent, consignee, operator, or master or other per- son for whom the overtime services are
p.000443: performed to file a bond in such amounts and containing such conditions and with such sure- ties, or in
p.000443: lieu of a bond, to deposit money or obligations of the United States in such amount, as will assure
p.000443: the payment of charges under this subsection, which bond or deposit may cover one or more transactions or all
p.000443: transactions during a specified period: Provided, That no charges shall be made for services performed in
p.000443: connection with the inspection of (1) persons arriving by inter- national highways, ferries, bridges, or
p.000443: tunnels, or the conveyances in which they arrive, or (2) persons arriving by aircraft or railroad trains, the
p.000443: operations of which are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons
p.000443: arriv- ing by vessels operated between Canadian ports and ports on Puget Sound or operated on the Great Lakes
p.000443: and connecting waterways, the operations of which are covered by published schedules, or the vessels in which they
p.000443: arrive.
p.000443: (2) Moneys collected under this subsection shall be deposited in
p.000443: the Treasury of the United States to the credit of the appropriation charged with the expense of the services, and the
p.000443: appropriations so credited shall be available for the payment of such compensation to the said employees for
p.000443: services so rendered.
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p.000445: (b) Any person who violates subsection (a) shall be fined not more than $50,000 or imprisoned not more than five years,
p.000445: or both.
p.000445: (c) For purposes of subsection (a):
p.000445: (1) The term ‘‘human organ’’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow,
p.000445: cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof,
p.000445: including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
p.000445: (2) The term ‘‘valuable consideration’’ does not include the reasonable payments associ- ated with the
p.000445: removal, transportation, implantation, processing, preservation, quality con- trol, and storage of a human
p.000445: organ or the expenses of travel, housing, and lost wages in- curred by the donor of a human organ in
p.000445: connection with the donation of the organ.
p.000445: (3) The term ‘‘interstate commerce’’ has the meaning prescribed for it by section 201(b) of the Federal
p.000445: Food, Drug and Cosmetic Act.
p.000445: 76 So in law. Subparagraphs (D) and (E) have the same text, and there are two subparagraphs (H). This results from the
p.000445: same set of amendments to section 371(b)(1) being enacted twice. The first set of amendments was made by section
p.000445: 701(c) of Public Law 106–505 (114 Stat. 2347). These amendments redesignated subparagraphs (D) through (G) as
p.000445: subparagraphs (E) through (H), respectively, and then added a new subparagraph (D). The second set was made by section
p.000445: 219(b) of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000445: Appropriations Act, 2001 (as enacted into law by section 1(a)(1) of Public Law 106– 554; 114 Stat.
p.000445: 2763A–29). Per the second set of amendments, the subparagraph (D) added by the first set was
p.000445: redesignated as (E), and the same text was again added as a subparagraph (D). Per the second set,
p.000445: subparagraphs (F) and (G), as redesignated by the first set, were redes- ignated as (G) and (H), which resulted in
p.000445: there being two subparagraphs (H).
p.000445: 77 So in law. Probably should be ‘‘paragraph (3)’’.
p.000445: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000447: PUBLIC HEALTH SERVICE ACT
p.000447: Sec. 371
p.000447:
p.000447: (II) rely on outcome and process performance measures that are based on empirical evidence, ob-
p.000447: tained through reasonable efforts, of organ donor po- tential and other related factors in each service
p.000447: area of qualified organ procurement organizations;
p.000447: (III) use multiple outcome measures as part of the certification process; and
p.000447: (IV) provide for a qualified organ procurement or- ganization to appeal a decertification to the Secretary on
p.000447: substantive and procedural grounds;
p.000447: (E) has procedures to obtain payment for non-renal organs provided to transplant centers,
p.000447: (F) has a defined service area that is of sufficient size to assure maximum effectiveness in the
...

p.000447: paragraph (3), and
p.000447: (iii) has no authority over any other activity of the or- ganization.
p.000447: (2)(A) Not later than 90 days after the date of the enactment of this paragraph, 80 the Secretary shall
p.000447: publish in the Federal Reg- ister a notice of proposed rulemaking to establish criteria for deter-
p.000447:
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p.000447:
p.000447: January 30, 2020
p.000447: 78 So in law. Probably should be ‘‘histocompatibility’’.
p.000447: 79 So in law. Probably should be paragraph (3).
p.000447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000447:
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p.000447: Sec. 371A PUBLIC HEALTH SERVICE ACT 448
p.000447:
p.000447: mining whether an entity meets the requirement established in paragraph (1)(E).
p.000447: (B) Not later than 1 year after the date of enactment of this paragraph, 80 the Secretary shall publish in
p.000447: the Federal Register a final rule to establish the criteria described in subparagraph (A).
p.000447: (3) An organ procurement organization shall—
p.000447: (A) have effective agreements, to identify potential organ donors, with a substantial majority of the
p.000447: hospitals and other health care entities in its service area which have facilities for organ donations,
p.000447: (B) conduct and participate in systematic efforts, including professional education, to acquire all usable organs from
p.000447: poten- tial donors,
p.000447: (C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of
p.000447: or- gans which are consistent with the standards adopted by the Organ Procurement and Transplantation
p.000447: Network under sec- tion 372(b)(2)(E), including arranging for testing with respect to identifying organs
p.000447: that are infected with human immuno- deficiency virus (HIV),
p.000447: (D) arrange for the appropriate tissue typing of donated or- gans,
p.000447: (E) have a system to allocate donated organs equitably among transplant patients according to established
p.000447: medical cri- teria,
p.000447: (F) provide or arrange for the transportation of donated or- gans to transplant centers,
p.000447: (G) have arrangements to coordinate its activities with transplant centers in its service area,
p.000447: (H) participate in the Organ Procurement Transplantation Network established under section 372,
p.000447: (I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage,
p.000447: and distribu- tion of tissues as may be appropriate to assure that all usable tissues are obtained from potential
p.000447: donors,
p.000447: (J) evaluate annually the effectiveness of the organization in acquiring potentially available organs, and
p.000447: (K) assist hospitals in establishing and implementing pro- tocols for making routine inquiries about organ
p.000447: donations by potential donors.
p.000447: (c) Pancreata procured by an organ procurement organization and used for islet cell transplantation or research
p.000447: shall be counted for purposes of certification or recertification under subsection (b).
...

p.000453: (2) the term ‘‘qualifying expenses’’ as including the ex- penses of having relatives or other
p.000453: individuals, not to exceed 2, accompany or assist the donating individual for purposes of subsection (a) (subject to
p.000453: making payment for only those types of expenses that are paid for a donating individual).
p.000453: (d) RELATIONSHIP TO PAYMENTS UNDER OTHER PROGRAMS.—An award may be made under subsection (a) only if the
p.000453: applicant in- volved agrees that the award will not be expended to pay the quali- fying expenses of a donating
p.000453: individual to the extent that payment has been made, or can reasonably be expected to be made, with re- spect to such
p.000453: expenses—
p.000453: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000453: health benefits program;
p.000453: (2) by an entity that provides health services on a prepaid basis; or
p.000453: (3) by the recipient of the organ.
p.000453: (e) DEFINITIONS.—For purposes of this section:
p.000453: (1) The term ‘‘donating individuals’’ has the meaning indi- cated for such term in subsection (a)(1), subject
p.000453: to subsection (c)(1).
p.000453: (2) The term ‘‘qualifying expenses’’ means the expenses au- thorized for purposes of subsection (a), subject to
p.000453: subsection (c)(2).
p.000453: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.000453: to be appropriated
p.000453: $5,000,000 for each of the fiscal years 2005 through 2009.
p.000453: SEC. 377A. ø274f–1¿ PUBLIC AWARENESS; STUDIES AND DEMONSTRA- TIONS.
p.000453: (a) ORGAN DONATION PUBLIC AWARENESS PROGRAM.—The Sec- retary shall, directly or through grants or contracts,
p.000453: establish a public education program in cooperation with existing national public awareness campaigns to
p.000453: increase awareness about organ do- nation and the need to provide for an adequate rate of such dona- tions.
p.000453: (b) STUDIES AND DEMONSTRATIONS.—The Secretary may make peer-reviewed grants to, or enter into peer-reviewed
p.000453: contracts with, public and nonprofit private entities for the purpose of carrying out studies and demonstration
p.000453: projects to increase organ donation and recovery rates, including living donation.
p.000453: (c) GRANTS TO STATES.—
p.000453: (1) IN GENERAL.—The Secretary may make grants to States for the purpose of assisting States in carrying
p.000453: out organ donor awareness, public education, and outreach activities and programs designed to increase the number
p.000453: of organ donors within the State, including living donors.
p.000453: (2) ELIGIBILITY.—To be eligible to receive a grant under this subsection, a State shall—
p.000453: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000453:
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p.000453: Sec. 377B PUBLIC HEALTH SERVICE ACT 454
p.000453:
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p.000453: January 30, 2020
p.000453:
p.000453: (A) submit an application to the Department in the form prescribed;
p.000453: (B) establish yearly benchmarks for improvement in organ donation rates in the State; and
p.000453: (C) report to the Secretary on an annual basis a de- scription and assessment of the State’s use of
p.000453: funds re- ceived under this subsection, accompanied by an assess- ment of initiatives for potential replication
p.000453: in other States.
p.000453: (3) USE OF FUNDS.—Funds received under this subsection may be used by the State, or in partnership with other
p.000453: public agencies or private sector institutions, for education and awareness efforts, information
p.000453: dissemination, activities per- taining to the State donor registry, and other innovative dona- tion specific
p.000453: initiatives, including living donation.
p.000453: (d) EDUCATIONAL ACTIVITIES.—The Secretary, in coordination with the Organ Procurement and Transplantation
p.000453: Network and other appropriate organizations, shall support the development and dissemination of educational
p.000453: materials to inform health care pro- fessionals and other appropriate professionals in issues sur-
p.000453: rounding organ, tissue, and eye donation including evidence-based proven methods to approach patients and
p.000453: their families, cultural sensitivities, and other relevant issues.
p.000453: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000453: to be appropriated
p.000453: $15,000,000 for fiscal year 2005, and such sums as may be nec- essary for each of the fiscal years 2006
p.000453: through 2009. Such author- ization of appropriations is in addition to any other authorizations of appropriations that
p.000453: are available for such purpose.
p.000453: SEC. 377B. ø274f–2¿ GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.
p.000453: (a) AUTHORITY.—
p.000453: (1) IN GENERAL.—The Secretary may award grants to qualified organ procurement organizations and hospitals
p.000453: under section 371 to establish programs coordinating organ donation activities of eligible hospitals and
...

p.000461: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000461: disease can be used to support casualties with marrow damage; and
p.000461: (viii) 85 with respect to the system under subparagraph (A), collect, analyze, and publish data in a
p.000461: standardized electronic format, as required by the Secretary, on the number and percentage of patients at
p.000461: each of the various stages of the search process, including data regarding the furthest stage reached,
p.000461: the number and percentage of pa- tients who are unable to complete the search process, and the reasons underlying
p.000461: such circumstances.
p.000461: (B) EFFORTS TO INCREASE COLLECTION OF HIGH QUAL- ITY CORD BLOOD UNITS.—In carrying out subparagraph
p.000461: (A)(iv), not later than 1 year after the date of enactment of the Stem Cell Therapeutic and Research
p.000461: Reauthoriza- tion Act of 2010 and annually thereafter, the Secretary shall set an annual goal of
p.000461: increasing collections of high quality cord blood units, øincluding remote collection,¿ 86 consistent with the
p.000461: inventory goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (re- ferred to in
p.000461: this subparagraph as the ‘‘inventory goal’’), and shall identify at least one project under subparagraph (A)(iv)
p.000461: to replicate and expand nationwide, as appropriate. If the Secretary cannot identify a project as described in
p.000461: the preceding sentence, the Secretary shall submit a plan, not later than 180 days after the date on which
p.000461: the Sec- retary was required to identify such a project, to the Com- mittee on Health, Education, Labor, and
p.000461: Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives for
p.000461: expanding collection of high quality cord blood units, øincluding remote collec- tion,¿ 86 consistent with
p.000461: the requirements under the Na- tional Cord Blood Inventory program under section 2 of the Stem Cell
p.000461: Therapeutic and Research Act of 2005 and
p.000461:
p.000461:
p.000461:
p.000461:
p.000461: January 30, 2020
p.000461: 86 Section 2(a)(2) of Public Law 114-104 amends subparagraph (B) by inserting ‘‘ including re- mote collection,’’ after
p.000461: ‘‘cord blood units,’’. Such amendment did not specify to which occurrence of the phrase ‘‘cord blood units,’’ to insert
p.000461: the new language.
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000463: 463
p.000463: PUBLIC HEALTH SERVICE ACT
p.000463: Sec. 379
p.000463:
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p.000463: standard dataset for purposes of subparagraph (A) in a standardized electronic format that enables
p.000463: transplant physicians to compare among and between bone marrow donors and cord blood units to ensure the
p.000463: best possible match for the patient.
p.000463: (4) DEFINITION.—The term ‘‘qualified cord blood bank’’ means a cord blood bank that—
p.000463: (A) has obtained all applicable Federal and State li- censes, certifications, registrations (including
p.000463: pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate
p.000463: and maintain a cord blood bank;
p.000463: (B) has implemented donor screening, cord blood col- lection practices, and processing methods intended to
p.000463: pro- tect the health and safety of donors and transplant recipi- ents to improve transplant outcomes, including
p.000463: with re- spect to the transmission of potentially harmful infections and other diseases;
p.000463: (C) is accredited by an accreditation entity recognized by the Secretary under subsection (b);
p.000463: (D) has established a system of strict confidentiality to protect the identity and privacy of patients and
p.000463: donors in accordance with existing Federal and State law;
p.000463: (E) has established a system for encouraging donation by a genetically diverse group of donors; and
p.000463: (F) has established a system to confidentially maintain linkage between a cord blood unit and a maternal
p.000463: donor.
p.000463: (e) BONE MARROW RECRUITMENT; PRIORITIES; INFORMATION AND EDUCATION.—
p.000463: (1) RECRUITMENT; PRIORITIES.—The Program shall carry out activities for the recruitment of bone marrow donors.
p.000463: Such recruitment program shall identify populations that are under- represented among potential donors enrolled
p.000463: with the Pro- gram. In the case of populations that are identified under the preceding sentence:
p.000463: (A) The Program shall give priority to carrying out ac- tivities under this part to increase representation for such
p.000463: populations in order to enable a member of such a popu-
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000463:
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p.000463: Sec. 379 PUBLIC HEALTH SERVICE ACT 464
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p.000463:
p.000463: lation, to the extent practicable, to have a probability of finding a suitable unrelated donor that is
p.000463: comparable to the probability that an individual who is not a member of an underrepresented population would have.
p.000463: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000463: to be populations that have been identified for purposes of this paragraph, and shall carry out
p.000463: subparagraph (A) with re- spect to such populations.
p.000463: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND ENROLLMENT.—
p.000463: (A) IN GENERAL.—The Program shall carry out infor- mational and educational activities, in coordination
p.000463: with organ donation public awareness campaigns operated through the Department of Health and Human
p.000463: Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll
p.000463: with the Program potential bone marrow donors. Such information and edu- cational activities shall include the
p.000463: following:
p.000463: (i) Making information available to the general public, including information describing the needs of
p.000463: patients with respect to donors of bone marrow.
p.000463: (ii) Educating and providing information to indi- viduals who are willing to serve as potential bone mar- row
p.000463: donors.
p.000463: (iii) Training individuals in requesting individuals to serve as potential bone marrow donors.
p.000463: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000463: Pro- gram shall give priority to recruiting individuals to serve as donors of bone marrow for populations
p.000463: that are identi- fied under paragraph (1).
p.000463: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000463: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000463: the public regarding bone marrow transplants from unrelated donors as a treatment op- tion.
...

p.000463: and the etiologic agent for Acquired Immune Deficiency Syndrome;
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000465: 465
p.000465: PUBLIC HEALTH SERVICE ACT
p.000465: Sec. 379
p.000465:
p.000465: (3) procedures to ensure the proper collection and trans- portation of the marrow;
p.000465: (4) standards for the system for patient advocacy operated under subsection (h), including standards requiring
p.000465: the provi- sion of appropriate information (at the start of the search proc- ess and throughout the process) to
p.000465: patients and their families and physicians;
p.000465: (5) standards that—
p.000465: (A) require the establishment of a system of strict con- fidentiality to protect the identity and privacy of
p.000465: patients and donors in accordance with Federal and State law; and
p.000465: (B) prescribe the purposes for which the records de- scribed in subparagraph (A) may be disclosed, and the cir-
p.000465: cumstances and extent of the disclosure; and
p.000465: (6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure
p.000465: the establishment of a method for integrating donor files, searches, and general procedures of the center or
p.000465: registry with the Pro- gram.
p.000465: (g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
p.000465: EDUCATION.—
p.000465: (1) RECRUITMENT; PRIORITIES.—The Program shall support activities, in cooperation with qualified cord blood
p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
p.000465:
p.000465:
p.000465:
p.000465:
p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000467: (i) The resources available through the Program.
p.000467: (ii) A comparison of transplant centers regarding search and other costs that prior to transplantation are
p.000467: charged to patients by transplant centers.
p.000467: (iii) The post-transplant outcomes for individual transplant centers.
p.000467: (iv) Information concerning issues that patients may face after a transplant.
p.000467: (v) Such other information as the Program deter- mines to be appropriate.
p.000467: (G) The Office shall conduct surveys of patients (or family members, physicians, or other individuals acting on
p.000467: behalf of patients) to determine the extent of satisfaction with the system for patient advocacy
p.000467: under this sub- section, and to identify ways in which the system can be improved to best meet the needs
p.000467: of patients.
p.000467: (3) CASE MANAGEMENT.—
p.000467: (A) IN GENERAL.—In serving as an advocate for a pa- tient under paragraph (2), the Office shall provide
p.000467: individ- ualized case management services directly to the patient (or family members, physicians, or other
p.000467: individuals acting on behalf of the patient), including—
p.000467: (i) individualized case assessment; and
p.000467: (ii) the functions described in paragraph (2)(D) (relating to progress in the search process).
p.000467: (B) POSTSEARCH FUNCTIONS.—In addition to the case management services described in paragraph (1) for pa-
p.000467: tients, the Office shall, on behalf of patients who have completed the search for a bone marrow donor
p.000467: or cord blood unit, provide information and education on the proc- ess of receiving a transplant, including the
p.000467: post-transplant process.
p.000467: (i) COMMENT PROCEDURES.—The Secretary shall establish and provide information to the public on procedures
p.000467: under which the Secretary shall receive and consider comments from interested per- sons relating to the manner
p.000467: in which the Program is carrying out the duties of the Program. The Secretary may promulgate regula-
p.000467: tions under this section.
p.000467: (j) CONSULTATION.—In developing policies affecting the Pro- gram, the Secretary shall consult with the
p.000467: Advisory Council, the Department of Defense Marrow Donor Recruitment and Research Program operated by the
p.000467: Department of the Navy, and the board of directors of each entity awarded a contract under this
p.000467: section.
p.000467: (k) CONTRACTS.—
p.000467: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: among agencies;
p.000471: (vi) enhancing interoperability between the pro- gram and any health information technology (includ- ing
p.000471: certified health information technology), including by integrating program data into such technology;
p.000471: (vii) updating program capabilities to respond to technological innovation for purposes of appropriately
p.000471: addressing the occurrence and evolution of controlled substance overdoses;
p.000471: (viii) facilitating and encouraging data exchange between the program and the prescription drug moni- toring
p.000471: programs of other States;
p.000471: (ix) enhancing data collection and quality, includ- ing improving patient matching and proactively moni- toring
p.000471: data quality;
p.000471: (x) providing prescriber and dispenser practice tools, including prescriber practice insight reports
p.000471: for practitioners to review their prescribing patterns in comparison to such patterns of other
p.000471: practitioners in the specialty; and
p.000471: (xi) meeting the purpose of the program estab- lished under section 399O, as described in section
p.000471: 399O(a).
p.000471: (B) Promoting community or health system interven- tions.
p.000471: (C) Evaluating interventions to prevent controlled sub- stance overdoses.
p.000471: (D) Implementing projects to advance an innovative prevention approach with respect to new and emerging
p.000471: public health crises and opportunities to address such cri- ses, such as enhancing public education and awareness on
p.000471: the risks associated with opioids.
p.000471: (3) ADDITIONAL GRANTS.—The Director may award grants to States, localities, and Indian Tribes—
p.000471: (A) to carry out innovative projects for grantees to rap- idly respond to controlled substance misuse, abuse,
p.000471: and overdoses, including changes in patterns of controlled sub- stance use; and
p.000471: (B) for any other evidence-based activity for pre- venting controlled substance misuse, abuse, and
p.000471: overdoses as the Director determines appropriate.
p.000471: (4) RESEARCH.—The Director, in coordination with the As- sistant Secretary for Mental Health and Substance Use
p.000471: and the National Mental Health and Substance Use Policy Labora- tory established under section 501A, as appropriate and
p.000471: appli- cable, may conduct studies and evaluations to address sub- stance use disorders, including
p.000471: preventing substance use dis-
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: Sec. 392A PUBLIC HEALTH SERVICE ACT 472
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p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
p.000471: coroners, medical examiners, and public health laboratories to im- prove accurate testing and
p.000471: standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of
p.000471: various opioid analogues to con- trolled substance overdoses.
p.000471: (F) Working to enable and encourage the access, ex- change, and use of information regarding controlled
p.000471: sub- stance overdoses among data sources and entities.
p.000471: (c) DEFINITIONS.—In this section:
p.000471: (1) CONTROLLED SUBSTANCE.—The term ‘‘controlled sub- stance’’ has the meaning given that term in section 102 of
p.000471: the Controlled Substances Act.
p.000471: (2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the mean- ing given that term in section 4 of the Indian
p.000471: Self-Determina- tion and Education Assistance Act.
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: 473
p.000473: PUBLIC HEALTH SERVICE ACT
p.000473: Sec. 393A
p.000473:
p.000473: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, section 399O of this Act, and
p.000473: section 102 of the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198), there is authorized
p.000473: to be appropriated $496,000,000 for each of fiscal years 2019 through 2023.
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p.000473: January 30, 2020
p.000473: INTERPERSONAL VIOLENCE WITHIN FAMILIES AND AMONG ACQUAINTANCES
p.000473: SEC. 393. ø280b–1a¿ (a) With respect to activities that are au- thorized in sections 391 and 392, the Secretary, acting
p.000473: through the Director of the Centers for Disease Control and Prevention, shall carry out such activities
p.000473: with respect to interpersonal violence within families and among acquaintances. Activities authorized in the
p.000473: preceding sentence include the following:
p.000473: (1) Collecting data relating to the incidence of such vio- lence.
p.000473: (2) Making grants to public and nonprofit private entities for the evaluation of programs whose purpose
p.000473: is to prevent such violence, including the evaluation of demonstration projects under paragraph (6).
p.000473: (3) Making grants to public and nonprofit private entities for the conduct of research on identifying
p.000473: effective strategies for preventing such violence.
p.000473: (4) Providing to the public information and education on such violence, including information and education to
p.000473: increase awareness of the public health consequences of such violence.
p.000473: (5) Training health care providers as follows:
p.000473: (A) To identify individuals whose medical conditions or statements indicate that the individuals are victims of
p.000473: such violence.
p.000473: (B) To routinely determine, in examining patients, whether the medical conditions or statements of the
p.000473: pa- tients so indicate.
p.000473: (C) To refer individuals so identified to entities that provide services regarding such violence,
p.000473: including refer- rals for counseling, housing, legal services, and services of community organizations.
p.000473: (6) Making grants to public and nonprofit private entities for demonstration projects with respect to
p.000473: such violence, in- cluding with respect to prevention.
p.000473: (b) For purposes of this part, the term ‘‘interpersonal violence within families and among acquaintances’’
p.000473: includes behavior com- monly referred to as domestic violence, sexual assault, spousal abuse, woman
p.000473: battering, partner abuse, elder abuse, and acquaint- ance rape.
p.000473: SEC. 393A. ø280b–1b¿ USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.
p.000473: (a) PERMITTED USE.—The Secretary, acting through the Na- tional Center for Injury Prevention and Control at the
p.000473: Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape
p.000473: prevention and education programs con- ducted by rape crisis centers, State, territorial or tribal sexual as-
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: Sec. 393A PUBLIC HEALTH SERVICE ACT 474
p.000473: sault coalitions, and other public and private nonprofit entities for—
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p.000473: January 30, 2020
p.000473: (1) educational seminars;
p.000473: (2) the operation of hotlines;
p.000473: (3) training programs for professionals;
p.000473: (4) the preparation of informational material;
p.000473: (5) education and training programs for students and cam- pus personnel designed to reduce the incidence of
p.000473: sexual as- sault at colleges and universities;
p.000473: (6) education to increase awareness about drugs and alco- hol used to facilitate rapes or sexual assaults; and
p.000473: (7) other efforts to increase awareness of the facts about, or to help prevent, sexual assault, including
p.000473: efforts to increase awareness in underserved communities and awareness among individuals with disabilities (as
p.000473: defined in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102)).
p.000473: (b) COLLECTION AND DISSEMINATION OF INFORMATION ON SEX- UAL ASSAULT.—The Secretary shall, through the National
p.000473: Resource Center on Sexual Assault established under the National Center for Injury Prevention and Control
p.000473: at the Centers for Disease Con- trol and Prevention, provide resource information, policy, training, and
p.000473: technical assistance to Federal, State, local, and Indian tribal agencies, as well as to State sexual assault
p.000473: coalitions and local sex- ual assault programs and to other professionals and interested par- ties on issues
p.000473: relating to sexual assault, including maintenance of a central resource library in order to collect, prepare,
p.000473: analyze, and disseminate information and statistics and analyses thereof relat- ing to the incidence and
p.000473: prevention of sexual assault.
p.000473: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.000473: (1) IN GENERAL.—There is authorized to be appropriated to carry out this section $50,000,000 for each of fiscal years
p.000473: 2014 through 2018.
p.000473: (2) NATIONAL SEXUAL VIOLENCE RESOURCE CENTER ALLOT- MENT.—Of the total amount made available under this
p.000473: sub- section in each fiscal year, not less than $1,500,000 shall be available for allotment under subsection
p.000473: (b).
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p.000473: subsection (a).
p.000473: (2) STUDIES.—A State may not use more than 2 percent of the amount received by the State under this section
p.000473: for each fiscal year for surveillance studies or prevalence studies.
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000475: PUBLIC HEALTH SERVICE ACT
p.000475: Sec. 393B
p.000475:
p.000475: (3) ADMINISTRATION.—A State may not use more than 5 percent of the amount received by the State under this
p.000475: section for each fiscal year for administrative expenses.
p.000475:
p.000475: PREVENTION OF TRAUMATIC BRAIN INJURY
p.000475: SEC. 393B. ø280b–1c¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000475: Control and Pre- vention, may carry out projects to reduce the incidence of traumatic brain injury. Such projects
p.000475: may be carried out by the Secretary di- rectly or through awards of grants or contracts to public or non-
p.000475: profit private entities. The Secretary may directly or through such awards provide technical assistance with
p.000475: respect to the planning, development, and operation of such projects.
p.000475: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000475: (1) the conduct of research into identifying effective strate- gies for the prevention of traumatic brain injury;
p.000475: (2) the implementation of public information and education programs for the prevention of such injury and for
p.000475: broadening the awareness of the public concerning the public health con- sequences of such injury; and
p.000475: (3) the implementation of a national education and aware- ness campaign regarding such injury (in conjunction
p.000475: with the program of the Secretary regarding health-status goals for 2020, commonly referred to as Healthy
p.000475: People 2020), includ- ing—
p.000475: (A) the national dissemination of information on—
p.000475: (i) incidence and prevalence; and
p.000475: (ii) information relating to traumatic brain injury and the sequelae of secondary conditions arising from
p.000475: traumatic brain injury upon discharge from hospitals and emergency departments; and
p.000475: (B) the provision of information in primary care set- tings, including emergency rooms and trauma centers, con-
p.000475: cerning the availability of State level services and re- sources.
p.000475: (c) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.000475: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities regarding
p.000475: traumatic brain injury.
p.000475: (d) DEFINITION.—For purposes of this section, the term ‘‘trau- matic brain injury’’ means an acquired
p.000475: injury to the brain. Such term does not include brain dysfunction caused by congenital or de- generative disorders,
p.000475: nor birth trauma, but may include brain inju- ries caused by anoxia due to trauma. The Secretary may revise the
p.000475: definition of such term as the Secretary determines necessary, after consultation with States and other
p.000475: appropriate public or nonprofit private entities.
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p.000475: (4) information characterizing the clinical aspects of the traumatic brain injury, including the severity
p.000475: of the injury, outcomes of the injury, the types of treatments received, and the types of services utilized.
p.000475: (b) Not later than 18 months after the date of enactment of the Traumatic Brain Injury Act of 2008, the Secretary,
p.000475: acting through the Director of the Centers for Disease Control and Prevention and the Director of the National
p.000475: Institutes of Health and in consulta- tion with the Secretary of Defense and the Secretary of Veterans
p.000475: Affairs, shall submit to the relevant committees of Congress a re- port that contains the findings
p.000475: derived from an evaluation con- cerning activities and procedures that can be implemented by the Centers
p.000475: for Disease Control and Prevention to improve the collec- tion and dissemination of compatible epidemiological
p.000475: studies on the incidence and prevalence of traumatic brain injury in individuals who were formerly in the
p.000475: military. The report shall include rec- ommendations on the manner in which such agencies can further
p.000475: collaborate on the development and improvement of traumatic brain injury diagnostic tools and treatments.
p.000475: (c) NATIONAL CONCUSSION DATA COLLECTION AND ANALYSIS.— The Secretary, acting through the Director of the
p.000475: Centers for Dis- ease Control and Prevention, may implement concussion data col- lection and analysis to
p.000475: determine the prevalence and incidence of concussion.
p.000475: SEC. 393D. ø28b–1f¿ PREVENTION OF FALLS AMONG OLDER ADULTS.
p.000475: (a) PUBLIC EDUCATION.—The Secretary may—
p.000475: (1) oversee and support a national education campaign to be carried out by a nonprofit organization with
p.000475: experience in
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p.000475: January 30, 2020
p.000475: 88 The amendment by section 2(3) of Public Law 110–206 to redesignate section 393B (relating to traumatic brain injury
p.000475: registeries) as section 393C could not be executed because such section had already been redesignated as section 393C
p.000475: by section 2(1) of Public Law 110–202.
p.000475: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000477: PUBLIC HEALTH SERVICE ACT
p.000477: Sec. 393D
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p.000477: designing and implementing national injury prevention pro- grams, that is directed principally to older
p.000477: adults, their fami- lies, and health care providers, and that focuses on reducing falls among older adults
p.000477: and preventing repeat falls; and
p.000477: (2) award grants, contracts, or cooperative agreements to qualified organizations, institutions, or
p.000477: consortia of qualified organizations and institutions, specializing, or demonstrating expertise, in falls or
p.000477: fall prevention, for the purpose of orga- nizing State-level coalitions of appropriate State and
p.000477: local agencies, safety, health, senior citizen, and other organizations to design and carry out local education
p.000477: campaigns, focusing on reducing falls among older adults and preventing repeat falls.
p.000477: (b) RESEARCH.—
p.000477: (1) IN GENERAL.—The Secretary may—
p.000477: (A) conduct and support research to—
p.000477: (i) improve the identification of older adults who have a high risk of falling;
p.000477: (ii) improve data collection and analysis to identify fall risk and protective factors;
p.000477: (iii) design, implement, and evaluate the most ef- fective fall prevention interventions;
p.000477: (iv) improve strategies that are proven to be effec- tive in reducing falls by tailoring these strategies to
p.000477: specific populations of older adults;
p.000477: (v) conduct research in order to maximize the dis- semination of proven, effective fall prevention inter-
p.000477: ventions;
p.000477: (vi) intensify proven interventions to prevent falls among older adults;
p.000477: (vii) improve the diagnosis, treatment, and reha- bilitation of elderly fall victims and older adults at
p.000477: high risk for falls; and
p.000477: (viii) assess the risk of falls occurring in various settings;
p.000477: (B) conduct research concerning barriers to the adop- tion of proven interventions with respect to the
p.000477: prevention of falls among older adults;
p.000477: (C) conduct research to develop, implement, and evalu- ate the most effective approaches to reducing falls
p.000477: among high-risk older adults living in communities and long-term care and assisted living facilities; and
p.000477: (D) evaluate the effectiveness of community programs designed to prevent falls among older adults.
p.000477: (2) EDUCATIONAL SUPPORT.—The Secretary, either directly or through awarding grants, contracts, or
p.000477: cooperative agree- ments to qualified organizations, institutions, or consortia of qualified organizations
p.000477: and institutions, specializing, or dem- onstrating expertise, in falls or fall prevention, may provide
p.000477: professional education for physicians and allied health profes- sionals, and aging service providers in fall
p.000477: prevention, evalua- tion, and management.
p.000477: (c) DEMONSTRATION PROJECTS.—The Secretary may carry out the following:
p.000477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000477: (1) Oversee and support demonstration and research projects to be carried out by qualified
p.000477: organizations, institu- tions, or consortia of qualified organizations and institutions, specializing, or
p.000477: demonstrating expertise, in falls or fall preven- tion, in the following areas:
p.000477: (A) A multistate demonstration project assessing the utility of targeted fall risk screening and referral
p.000477: pro- grams.
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p.000483: has been made, or can reasonably be expected to be made, with re- spect to such item or service—
p.000483: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000483: health benefits program; or
p.000483: (2) by an entity that provides health services on a prepaid basis.
p.000483: (f) 93 NON-DUPLICATION OF EFFORT.—The Secretary shall en- sure that activities under any
p.000483: cooperative agreement awarded under this subpart do not unnecessarily duplicate efforts of other agencies
p.000483: and offices within the Department of Health and Human Services related to—
p.000483: (1) activities of centers of excellence with respect to Alz- heimer’s disease and related dementias
p.000483: described in section 398A; and
p.000483: (2) activities of public health departments with respect to Alzheimer’s disease and related dementias
p.000483: described in this section.
p.000483: SEC. 398A. ø280c–4¿ PROMOTION OF PUBLIC HEALTH KNOWLEDGE AND AWARENESS OF ALZHEIMER’S DISEASE AND RELATED DE- MENTIAS.
p.000483: (a) ALZHEIMER’S DISEASE AND RELATED DEMENTIAS PUBLIC HEALTH CENTERS OF EXCELLENCE.—
p.000483: (1) IN GENERAL.—The Secretary, in coordination with the Director of the Centers for Disease Control and
p.000483: Prevention and the heads of other agencies as appropriate, shall award grants, contracts, or cooperative agreements
p.000483: to eligible entities, such as institutions of higher education, State, tribal, and local health
p.000483: departments, Indian tribes, tribal organizations, asso- ciations, or other appropriate entities for the
p.000483: establishment or support of regional centers to address Alzheimer’s disease and related dementias by—
p.000483: (A) advancing the awareness of public health officials, health care professionals, and the public, on the most cur-
p.000483: rent information and research related to Alzheimer’s dis- ease and related dementias, including cognitive
p.000483: decline, brain health, and associated health disparities;
p.000483: (B) identifying and translating promising research findings, such as findings from research and activities
p.000483: con- ducted or supported by the National Institutes of Health, including Alzheimer’s Disease Research
p.000483: Centers author- ized by section 445, into evidence-based programmatic interventions for populations with
p.000483: Alzheimer’s disease and related dementias and caregivers for such populations; and
p.000483: (C) expanding activities, including through public-pri- vate partnerships related to Alzheimer’s disease and
p.000483: re- lated dementias and associated health disparities.
p.000483: (2) REQUIREMENTS.—To be eligible to receive a grant, con- tract, or cooperative agreement under this subsection, an
p.000483: enti- ty shall submit to the Secretary an application containing such
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p.000483: 93 The placement of subsection (f) (as added to the end of the section by section 3(7) of Public Law 115–406) is so in
p.000483: law. The amendment probably should have been made to insert this new subsection before subsection (g) (as
p.000483: redesignated).
p.000483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000485: under this subsection, not later than 90 days after the end of the first year of the period of
p.000485: assistance, and annually there- after for the duration of the grant, contract, or agreement (in- cluding the
p.000485: duration of any renewal period as provided for under paragraph (5)), the entity shall submit data, as
p.000485: appro- priate, to the Secretary regarding—
p.000485: (A) the programs and activities funded under the grant, contract, or agreement; and
p.000485: (B) outcomes related to such programs and activities.
p.000485: (b) IMPROVING DATA ON STATE AND NATIONAL PREVALENCE OF
p.000485: ALZHEIMER’S DISEASE AND RELATED DEMENTIAS.—
p.000485: (1) IN GENERAL.—The Secretary shall, as appropriate, im- prove the analysis and timely reporting of data
p.000485: on the inci- dence and prevalence of Alzheimer’s disease and related de- mentias. Such data may include,
p.000485: as appropriate, information on cognitive decline, caregiving, and health disparities experi- enced by
p.000485: individuals with cognitive decline and their care- givers. The Secretary may award grants, contracts, or coopera-
p.000485: tive agreements to eligible entities for activities under this paragraph.
p.000485: (2) ELIGIBILITY.—To be eligible to receive a grant, contract, or cooperative agreement under this subsection, an entity
p.000485: shall be a public or nonprofit private entity, including institutions of higher education, State, local, and
p.000485: tribal health departments, and Indian tribes and tribal organizations, and submit to the Secretary an
p.000485: application at such time, in such manner, and containing such information as the Secretary may require.
p.000485: (3) DATA SOURCES.—The analysis, timely public reporting, and dissemination of data under this subsection may be
p.000485: carried out using data sources such as the following:
p.000485: (A) The Behavioral Risk Factor Surveillance System.
p.000485: (B) The National Health and Nutrition Examination Survey.
p.000485: (C) The National Health Interview Survey.
p.000485: (c) IMPROVED COORDINATION.—The Secretary shall ensure that activities and programs related to dementia under
p.000485: this section do not unnecessarily duplicate activities and programs of other agen- cies and offices within
p.000485: the Department of Health and Human Serv- ices.
p.000485: SEC. 398B. ø280c–5¿ GENERAL PROVISIONS.
p.000485: (a) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make a grant or cooperative agreement under
p.000485: sections 398 or 398A to an entity unless the entity agrees that not more than 5 percent of the grant
p.000485: or cooperative agreement will be expended for administrative expenses with respect to the grant or cooperative
p.000485: agreement.
p.000485: (b) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under sections 398 or 398A to an
p.000485: entity unless the entity has submitted to the Secretary an application for the grant. The application shall—
p.000485: (1) contain the description of intended expenditures;
p.000485: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: PUBLIC HEALTH SERVICE ACT
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p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
p.000491: drug treatment services, and the utilization of such services provided by the grantee; and
p.000491: (9) the incidence of developmental disabilities.
p.000491: (n) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under subsection (a) only if—
p.000491: (1) an application for the grant is submitted to the Sec- retary;
p.000491: (2) the application contains the agreements and assur- ances required in this section, and the information
p.000491: required in subsection (j);
p.000491: (3) the application contains evidence that the preparation of the application has been coordinated with the
p.000491: State agencies responsible for maternal and child health and child welfare, and coordinated with services
p.000491: provided under part C of the In- dividuals with Disabilities Education Act; and
p.000491: (4) the application is in such form, is made in such man- ner, and contains such agreements,
p.000491: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000491: (o) PEER REVIEW.—
p.000491: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000491: the recommendations of the peer review panel established under paragraph (2).
p.000491: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000491: (1) that shall be composed of—
p.000491: (A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of
p.000491: com- munity-based primary health services; and
p.000491: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000491: the Substance Abuse and Mental Health Services Adminis- tration, the Administration for Children, Youth, and Fami-
p.000491: lies, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
p.000491: (p) EVALUATIONS.—
p.000491: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities—
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p.000493: garding the provision of services to the public.
p.000493: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000493: the appli- cant involved agrees to make available (directly or through agree- ments with other entities) to
p.000493: children of substance abusers each of the following services:
p.000493: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: PUBLIC HEALTH SERVICE ACT
p.000495: Sec. 399A
p.000495:
p.000495: (1) Periodic evaluation of children for developmental, psy- chological, and medical problems.
p.000495: (2) Primary pediatric care.
p.000495: (3) Other necessary health and mental health services.
p.000495: (4) Therapeutic intervention services for children, includ- ing provision of therapeutic child care.
p.000495: (5) Preventive counseling services.
p.000495: (6) Counseling related to the witnessing of chronic vio- lence.
p.000495: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000495: (A) education and special education programs;
p.000495: (B) Head Start programs established under the Head Start Act;
p.000495: (C) other early childhood programs;
p.000495: (D) employment and training programs;
p.000495: (E) public assistance programs provided by Federal,
p.000495: State, or local governments; and
p.000495: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000495: (8) Additional developmental services that are consistent with the provision of early intervention services, as
p.000495: such term is defined in part C of the Individuals with Disabilities Edu- cation Act.
p.000495: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000495: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000495: available (directly or through agreements with other entities) each of the following services, as
p.000495: applicable to the family member involved:
p.000495: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000495: professional, or by a trained worker from the community who is supervised by a profes- sional:
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p.000495: (A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and
p.000495: services for children of substance abusers.
p.000495: (B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining
p.000495: the services described in subsection (b) for their children.
p.000495: (C) Visiting and providing support to substance abus- ers, especially pregnant women, who are receiving
p.000495: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000495: (2) In the case of substance abusers:
p.000495: (A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
p.000495: (B) Primary health care and mental health services, including prenatal and post partum care for
p.000495: pregnant women.
p.000495: (C) Consultation and referral regarding subsequent pregnancies and life options, including education and
p.000495: ca- reer planning.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: Sec. 399A PUBLIC HEALTH SERVICE ACT 496
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p.000495: (D) Where appropriate, counseling regarding family conflict and violence.
p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
p.000495: (e) FEDERAL SHARE.—The Federal share of a program carried out under subsection (a) shall be 90 percent.
p.000495: The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by
p.000495: the grant recipient as a part or all of the non- Federal share of grants.
p.000495: (f) COORDINATION WITH OTHER PROVIDERS.—The Secretary may make a grant under subsection (a) only if
p.000495: the applicant in- volved agrees to coordinate its activities with those of the State lead agency, and
p.000495: the State Interagency Coordinating Council, under part C of the Individuals with Disabilities Education Act.
p.000495: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: PUBLIC HEALTH SERVICE ACT
p.000497: Sec. 399A
p.000497:
p.000497: (g) RESTRICTIONS ON USE OF GRANT.—The Secretary may make a grant under subsection (a) only if the
p.000497: applicant involved agrees that the grant will not be expended—
p.000497: (1) to provide inpatient hospital services;
p.000497: (2) to make cash payments to intended recipients of serv- ices;
p.000497: (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any
p.000497: build- ing or other facility, or purchase major medical equipment;
p.000497: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.000497: of Federal funds; or
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p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
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p.000501: providers, Head Start, schools and after-school programs, early childhood development programs,
p.000501: community-based family resource and support centers, the criminal justice system, health, substance abuse
p.000501: and mental health pro- viders through screenings conducted during regular child- hood examinations and other
p.000501: examinations, self and family member referrals, substance abuse treatment services, and other providers of
p.000501: services to children and families; and
p.000501: (D) to provide education and training to health, sub- stance abuse and mental health professionals, and
p.000501: other providers of services to children and families through youth service agencies, family social services, child
p.000501: care, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000501: family resource and support centers, the criminal justice system, and other providers of services to children and
p.000501: families.
p.000501: (2) ADMINISTRATIVE CONSULTATIONS.—The Administrator of the Administration for Children, Youth, and Families
p.000501: and the Administrator of the Health Resources and Services Admin- istration shall be consulted regarding the
p.000501: promulgation of pro- gram guidelines and funding priorities under this section.
p.000501: (3) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000501: (A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the
p.000501: case of any service under such paragraph that is covered in the State plan approved under title XIX of
p.000501: the Social Security Act for the State involved—
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p.000501:
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p.000501:
p.000501: (b) SERVICES FOR CHILDREN OF SUBSTANCE ABUSERS.—The Secretary may make a grant under subsection (a) only if
p.000501: the appli- cant involved agrees to make available (directly or through agree- ments with other entities)
p.000501: to children of substance abusers each of the following services:
p.000501: (1) Periodic evaluation of children for developmental, psy- chological, alcohol and drug, and medical problems.
p.000501: (2) Primary pediatric care.
p.000501: (3) Other necessary health and mental health services.
p.000501: (4) Therapeutic intervention services for children, including provision of therapeutic child care.
p.000501: (5) Developmentally and age-appropriate drug and alcohol early intervention, treatment and prevention services.
p.000501: (6) Counseling related to the witnessing of chronic violence.
p.000501: (7) Referrals for, and assistance in establishing eligibility for, services provided under—
p.000501: (A) education and special education programs;
p.000501: (B) Head Start programs established under the Head Start Act;
p.000501: (C) other early childhood programs;
p.000501: (D) employment and training programs;
p.000501: (E) public assistance programs provided by Federal,
p.000501: State, or local governments; and
p.000501: (F) programs offered by vocational rehabilitation agen- cies, recreation departments, and housing agencies.
p.000501: (8) Additional developmental services that are consistent with the provision of early intervention
p.000501: services, as such term is defined in part H of the Individuals with Disabilities Edu- cation Act.
p.000501: Services shall be provided under paragraphs (2) through (8) by a public health nurse, social worker, or
p.000501: similar professional, or by a trained worker from the community who is supervised by a profes- sional, or
p.000501: by an entity, where the professional or entity provides as- surances that the professional or entity is licensed or
p.000501: certified by the State if required and is complying with applicable licensure or cer- tification requirements.
p.000501: (c) SERVICES FOR AFFECTED FAMILIES.—The Secretary may make a grant under subsection (a) only if, in
p.000501: the case of families in which a member is a substance abuser, the applicant involved agrees to make
p.000501: available (directly or through agreements with other entities) each of the following services, as applicable to
p.000501: the family member involved:
p.000501: (1) Services as follows, to be provided by a public health nurse, social worker, or similar
p.000501: professional, or by a trained worker from the community who is supervised by a profes- sional, or by an
...

p.000503: sub- stance abuse treatment services or whose children are re- ceiving services under subsection (b).
p.000503: (D) Aggressive outreach to family members with sub- stance abuse problems.
p.000503: (E) Inclusion of consumer in the development, imple- mentation, and monitoring of Family Services Plan.
p.000503: (2) In the case of substance abusers:
p.000503: (A) Alcohol and drug treatment services, including screening and assessment, diagnosis, detoxification,
p.000503: indi- vidual, group and family counseling, relapse prevention, pharmacotherapy treatment, after-care
p.000503: services, and case management.
p.000503: (B) Primary health care and mental health services, in- cluding prenatal and post partum care for
p.000503: pregnant women.
p.000503: (C) Consultation and referral regarding subsequent pregnancies and life options and counseling on the human
p.000503: immunodeficiency virus and acquired immune deficiency syndrome.
p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
...

p.000503: the appli- cant involved submits to the Secretary—
p.000503: (1) a description of the population that is to receive services under this section and a description of such services
p.000503: that are to be provided and measurable goals and objectives;
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000503:
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p.000505: 505
p.000505: PUBLIC HEALTH SERVICE ACT
p.000505: Sec. 399A
p.000505:
p.000505: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for health,
p.000505: including maternal and child health 95 mental health, child welfare, edu- cation, juvenile justice, developmental
p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
...

p.000513: func- tion of the fund established under such paragraph. Such en- dowments may be expended only for the
p.000513: compensation of indi- viduals holding the positions, for staff, equipment, quarters, travel, and other
p.000513: expenditures that are appropriate in sup- porting the positions, and for recruiting individuals to hold the
p.000513: positions endowed by the fund.
p.000513: (d) CERTAIN ACTIVITIES OF FOUNDATION.—In carrying out sub- section (b), the Foundation may provide for the
p.000513: following with re- spect to the purpose described in such subsection:
p.000513: (1) Programs of fellowships for State and local public health officials to work and study in
p.000513: association with the Cen- ters for Disease Control and Prevention.
p.000513: (2) Programs of international arrangements to provide op- portunities for public health officials of other countries to
p.000513: serve in public health capacities in the United States in association with the Centers for Disease
p.000513: Control and Prevention or else- where, or opportunities for employees of such Centers (or other public health
p.000513: officials in the United States) to serve in such ca- pacities in other countries, or both.
p.000513: (3) Studies, projects, and research (which may include ap- plied research on the effectiveness of prevention
p.000513: activities, demonstration projects, and programs and projects involving international, Federal, State, and local
p.000513: governments).
p.000513: (4) Forums for government officials and appropriate pri- vate entities to exchange information.
p.000513: Participants in such fo- rums may include institutions of higher education and appro- priate international
p.000513: organizations.
p.000513: (5) Meetings, conferences, courses, and training workshops.
p.000513: (6) Programs to improve the collection and analysis of data on the health status of various populations.
p.000513: (7) Programs for writing, editing, printing, and publishing of books and other materials.
p.000513: (8) Other activities to carry out the purpose described in subsection (b).
p.000513: (e) GENERAL STRUCTURE OF FOUNDATION; NONPROFIT STA-
p.000513: TUS.—
p.000513:
p.000513:
p.000513:
p.000513:
p.000513: January 30, 2020
p.000513: (1) BOARD OF DIRECTORS.—The Foundation shall have a board of directors (in this part referred to as the
p.000513: ‘‘Board’’), which shall be established and conducted in accordance with subsection (f). The Board shall
p.000513: establish the general policies of
p.000513: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000515: 515
p.000515: PUBLIC HEALTH SERVICE ACT
p.000515: Sec. 399G
p.000515:
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p.000515: (B) is, under subsection (a) of such section, exempt from taxation.
p.000515: (f) BOARD OF DIRECTORS.—
p.000515: (1) CERTAIN BYLAWS.—
p.000515: (A) In establishing bylaws under subsection (e)(1), the Board shall ensure that the bylaws of the Foundation
p.000515: in- clude bylaws for the following:
p.000515: (i) Policies for the selection of the officers, employ- ees, agents, and contractors of the Foundation.
p.000515: (ii) Policies, including ethical standards, for the acceptance and disposition of donations to the Founda- tion
p.000515: and for the disposition of the assets of the Foun- dation.
p.000515: (iii) Policies for the conduct of the general oper- ations of the Foundation.
p.000515: (iv) Policies for writing, editing, printing, and pub- lishing of books and other materials, and the acquisi-
p.000515: tion of patents and licenses for devices and procedures developed by the Foundation.
p.000515: (B) In establishing bylaws under subsection (e)(1), the Board shall ensure that the bylaws of the Foundation (and
p.000515: activities carried out under the bylaws) do not—
p.000515: (i) reflect unfavorably upon the ability of the Foundation, or the Centers for Disease Control and
p.000515: Prevention, to carry out its responsibilities or official duties in a fair and objective manner; or
p.000515: (ii) compromise, or appear to compromise, the in- tegrity of any governmental program or any officer or
p.000515: employee involved in such program.
p.000515: (2) COMPOSITION.—
p.000515: (A) Subject to subparagraph (B), the Board shall be composed of 7 individuals, appointed in accordance
p.000515: with paragraph (4), who collectively possess education or experi- ence appropriate for representing the general field
p.000515: of pub- lic health, the general field of international health, and the general public. Each such individual shall
p.000515: be a voting member of the Board.
p.000515: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000515:
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p.000515: Sec. 399G PUBLIC HEALTH SERVICE ACT 516
p.000515:
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p.000515: January 30, 2020
p.000515:
p.000515: (B) The Board may, through amendments to the by- laws of the Foundation, provide that the number of
p.000515: mem- bers of the Board shall be a greater number than the num- ber specified in subparagraph (A).
p.000515: (3) CHAIR.—The Board shall, from among the members of the Board, designate an individual to serve as the chair
p.000515: of the Board (in this subsection referred to as the ‘‘Chair’’).
...

p.000521: re- late to the operation of the Committee.
p.000521: (C) The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes
p.000521: an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant
p.000521: may be made only if an application for the grant is
p.000521:
p.000521:
p.000521:
p.000521: January 30, 2020
p.000521: 102 Enacted October 27, 1992.
p.000521:
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000521:
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p.000521: Sec. 399H PUBLIC HEALTH SERVICE ACT 522
p.000521:
p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: January 30, 2020
p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: (d) NATIONAL TASK FORCE.—
p.000523: (1) IN GENERAL.—The Secretary shall establish a task force to be known as the National Task Force on Fetal Alcohol
p.000523: Syn- drome and Fetal Alcohol Effect (referred to in this subsection as the ‘‘Task Force’’) to foster
p.000523: coordination among all govern- mental agencies, academic bodies and community groups that conduct or
p.000523: support Fetal Alcohol Syndrome and Fetal Alcohol Effect research, programs, and surveillance, and
p.000523: otherwise meet the general needs of populations actually or potentially impacted by Fetal Alcohol Syndrome
p.000523: and Fetal Alcohol Effect.
p.000523: (2) MEMBERSHIP.—The Task Force established pursuant to paragraph (1) shall—
p.000523: (A) be chaired by an individual to be appointed by the Secretary and staffed by the Administration; and
p.000523: (B) include the Chairperson of the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the De-
p.000523: partment of Health and Human Services, individuals with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and rep-
p.000523: resentatives from advocacy and research organizations such as the Research Society on Alcoholism, the FAS
p.000523: Fam- ily Resource Institute, the National Organization of Fetal Alcohol Syndrome, the Arc, the academic
p.000523: community, and Federal, State and local government agencies and offices.
p.000523: (3) FUNCTIONS.—The Task Force shall—
p.000523: (A) advise Federal, State and local programs and re- search concerning Fetal Alcohol Syndrome and Fetal Alco-
p.000523: hol Effect, including programs and research concerning education and public awareness for relevant service
p.000523: pro- viders, school-age children, women at-risk, and the general public, medical diagnosis, interventions for
p.000523: women at-risk of giving birth to children with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and
p.000523: beneficial services for indi- viduals with Fetal Alcohol Syndrome and Fetal Alcohol Ef- fect and their families;
p.000523: (B) coordinate its efforts with the Interagency Coordi- nating Committee on Fetal Alcohol Syndrome of the
p.000523: De- partment of Health and Human Services; and
p.000523: (C) report on a biennial basis to the Secretary and rel- evant committees of Congress on the current and planned
p.000523: activities of the participating agencies.
p.000523: (4) TIME FOR APPOINTMENT.—The members of the Task Force shall be appointed by the Secretary not later
p.000523: than 6 months after the date of enactment of this part.
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000523:
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p.000523: Sec. 399I PUBLIC HEALTH SERVICE ACT 524
p.000523:
p.000523: SEC. 399I. ø280f–1¿ ELIGIBILITY.
...

p.000523: (a) IN GENERAL.—There are authorized to be appropriated to carry out this part, $27,000,000 for each of
p.000523: the fiscal years 1999 through 2003.
p.000523: (b) TASK FORCE.—From amounts appropriated for a fiscal year under subsection (a), the Secretary may use
p.000523: not to exceed
p.000523: $2,000,000 of such amounts for the operations of the National Task Force under section 399H(d).
p.000523: SEC. 399K. ø280f–3¿ SUNSET PROVISION.
p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
p.000523:
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p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
p.000525: families, including patient education regarding asthma management, family education on asthma
p.000525: management, and the distribution of materials, including displays and videos, to reinforce concepts
p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
p.000525: or high rate of hos- pitalization or emergency room visits for asthma (relative to the average
p.000525: asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate
p.000525: a high prevalence of childhood asthma or high asthma-related mortality may include data from Fed- eral, State, or
p.000525: local vital statistics, claims data under title XIX or XXI of the Social Security Act, other public health
p.000525: statistics or surveys, or other data that the Secretary, in consultation with the Director of the
p.000525: Centers for Disease Control and Prevention, deems appropriate.
p.000525: (3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a
...

p.000527: certification made by the State attorney general that the State has re- viewed any applicable civil liability
p.000527: protection law to deter- mine the application of such law with regard to elemen- tary and secondary school
p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
p.000527: (iii) whose training in the administration of epi- nephrine meets appropriate medical standards and
p.000527: has been documented by appropriate administrative staff of the school.
p.000527: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000527: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000527: SEC. 399M. ø280g–1¿ EARLY DETECTION, DIAGNOSIS, AND TREATMENT REGARDING DEAF AND HARD-OF-HEARING NEWBORNS,
...

p.000527: SYS-
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: 529
p.000529: PUBLIC HEALTH SERVICE ACT
p.000529: Sec. 399M
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p.000529: January 30, 2020
p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
p.000529: (including medical homes for children), and in programs mandated by part C of the Individuals with Disabilities
p.000529: Education Act, which offer programs specifically designed to meet the unique language and communication
p.000529: needs of deaf and hard-of-hearing children.
p.000529: (B) Information provided to families should be accu- rate, comprehensive, up-to-date, and evidence-based,
p.000529: as appropriate, to allow families to make important decisions for their children in a timely manner, including
p.000529: decisions with respect to the full range of assistive hearing tech- nologies and communications modalities, as
p.000529: appropriate.
p.000529: (C) Programs and systems under this paragraph shall offer mechanisms that foster family-to-family and deaf and
p.000529: hard-of-hearing consumer-to-family supports.
p.000529: (2) To continue to provide technical support to States, through one or more technical resource centers, to
p.000529: assist in fur- ther developing and enhancing State early hearing detection and intervention programs.
p.000529: (3) To identify or develop efficient models (educational and medical) to ensure that children who are identified
p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
p.000529:
p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
p.000529: child hearing screening, evaluation (including audiologic, medical, and language acquisition
p.000529: evalua- tions), diagnosis, and intervention services;
p.000529: (ii) to conduct applied research related to new- born, infant, and young child hearing screening, eval-
p.000529: uation, and intervention programs and outcomes;
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p.000531: 531
p.000531: PUBLIC HEALTH SERVICE ACT
p.000531: Sec. 399M
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p.000531: January 30, 2020
p.000531: (1) IN GENERAL.—In carrying out programs under this sec- tion, the Administrator of the Health Resources and
p.000531: Services Administration, the Director of the Centers for Disease Control and Prevention, and the Director of the
p.000531: National Institutes of Health shall collaborate and consult with—
p.000531: (A) other Federal agencies;
p.000531: (B) State and local agencies, including agencies re- sponsible for early intervention services pursuant to
p.000531: title XIX of the Social Security Act (Medicaid Early and Peri- odic Screening, Diagnosis and Treatment
p.000531: Program); title XXI of the Social Security Act (State Children’s Health In- surance Program); title V of the
p.000531: Social Security Act (Ma- ternal and Child Health Block Grant Program); and part C of the Individuals with
p.000531: Disabilities Education Act;
p.000531: (C) consumer groups of, and that serve, individuals who are deaf and hard-of-hearing and their families;
p.000531: (D) appropriate national medical and other health and education specialty organizations;
p.000531: (E) individuals who are deaf or hard-of-hearing and their families;
p.000531: (F) other qualified professional personnel who are pro- ficient in deaf or hard-of-hearing children’s language
p.000531: and who possess the specialized knowledge, skills, and at- tributes needed to serve deaf and
p.000531: hard-of-hearing children, and their families;
p.000531: (G) third-party payers and managed care organiza- tions; and
p.000531: (H) related commercial industries.
p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
...

p.000535: Federal and State laws and pro- vided that such reports shall not include protected health in- formation;
p.000535: and
p.000535: (4) may access information about prescriptions, such as claims data, to ensure that such prescribing and
p.000535: dispensing history is updated in as close to real-time as practicable, in compliance with applicable
p.000535: Federal and State laws and pro- vided that such information shall not include protected health information.
p.000535: (d) EVALUATION AND REPORTING.—As a condition on receipt of support under this section, the State shall
p.000535: report on interoper- ability with PDMPs of other States and Federal agencies, where appropriate,
p.000535: intrastate interoperability with health information technology systems such as electronic health records,
p.000535: health infor- mation exchanges, and e-prescribing, where appropriate, and whether or not the State
p.000535: provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a
p.000535: practitioner, where permitted) requests information about such patient.
p.000535: (e) EVALUATION AND REPORTING.—A State receiving support under this section shall provide the Secretary with
p.000535: aggregate non- identifiable information, as permitted by State law, to enable the Secretary—
p.000535: (1) to evaluate the success of the State’s program in achieving the purpose described in subsection
p.000535: (a); or
p.000535: (2) to prepare and submit to the Congress the report re- quired by subsection (i)(2).
p.000535: (f) EDUCATION AND ACCESS TO THE MONITORING SYSTEM.—A State receiving support under this section shall take
p.000535: steps to—
p.000535: (1) facilitate prescribers and dispensers, and their dele- gates, as permitted by State law, to use the PDMP, to
p.000535: the ex- tent practicable; and
p.000535: (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs.
p.000535: (g) ELECTRONIC FORMAT.—The Secretary may issue guidelines specifying a uniform electronic format for the
p.000535: reporting, sharing, and disclosure of information pursuant to PDMPs. To the extent possible, such
p.000535: guidelines shall be consistent with standards recog- nized by the Office of the National Coordinator for Health
p.000535: Informa- tion Technology.
p.000535: (h) RULES OF CONSTRUCTION.—
p.000535: (1) FUNCTIONS OTHERWISE AUTHORIZED BY LAW.—Nothing in this section shall be construed to restrict the
p.000535: ability of any authority, including any local, State, or Federal law enforce- ment, narcotics control,
p.000535: licensure, disciplinary, or program au- thority, to perform functions otherwise authorized by law.
p.000535: (2) ADDITIONAL PRIVACY PROTECTIONS.—Nothing in this section shall be construed as preempting any State
p.000535: from im- posing any additional privacy protections.
p.000535: (3) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this sec- tion shall be construed to supersede any Federal
p.000535: privacy or
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000537: controlled sub- stance for the person’s own use, for the use of a member of the person’s household, or for the
p.000537: use of an animal owned by the person or by a member of the person’s household.
p.000537: (11) The term ‘‘clinical workflow’’ means the integration of automated queries for prescription drug monitoring
p.000537: programs
p.000537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: PUBLIC HEALTH SERVICE ACT
p.000539: Sec. 399P
p.000539:
p.000539: data and analytics into health information technologies such as electronic health record systems, health information
p.000539: exchanges, and/or pharmacy dispensing software systems, thus stream- lining provider access through automated
p.000539: queries.
p.000539: SEC. 399P. ø280g–4¿ GRANTS TO STRENGTHEN THE HEALTHCARE SYS- TEM’S RESPONSE TO DOMESTIC VIOLENCE, DATING
p.000539: VIO- LENCE, SEXUAL ASSAULT, AND STALKING.
p.000539: (a) IN GENERAL.—The Secretary shall award grants for—
p.000539: (1) the development or enhancement and implementation of interdisciplinary training for health
p.000539: professionals, public health staff, and allied health professionals;
p.000539: (2) the development or enhancement and implementation of education programs for medical, nursing, dental,
p.000539: and other health profession students and residents to prevent and re- spond to domestic violence, dating
p.000539: violence, sexual assault, and stalking; and
p.000539: (3) the development or enhancement and implementation of comprehensive statewide strategies to improve the
p.000539: response of clinics, public health facilities, hospitals, and other health settings (including behavioral
p.000539: and mental health programs) to domestic violence, dating violence, sexual assault, and stalking.
p.000539: (b) USE OF FUNDS.—
p.000539: (1) REQUIRED USES.—Amounts provided under a grant under this section shall be used to—
p.000539: (A) fund interdisciplinary training and education pro- grams under paragraphs (1) and (2) of
p.000539: subsection (a) that—
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p.000539: (i) are designed to train medical, psychology, den- tal, social work, nursing, and other health profession
p.000539: students, interns, residents, fellows, or current health care providers to identify and provide health care serv-
p.000539: ices (including mental or behavioral health care serv- ices and referrals to appropriate community
p.000539: services) to individuals who are or who have been victims of do- mestic violence, dating violence, sexual
p.000539: assault, or stalking; and
p.000539: (ii) plan and develop culturally competent clinical training components for integration into approved in-
p.000539: ternship, residency, and fellowship training or con- tinuing medical or other health education training
p.000539: that address physical, mental, and behavioral health issues, including protective factors, related to domestic
p.000539: violence, dating violence, sexual assault, stalking, and other forms of violence and abuse, focus on reducing
p.000539: health disparities and preventing violence and abuse, and include the primacy of victim safety and confiden-
p.000539: tiality;
p.000539: (B) design and implement comprehensive strategies to improve the response of the health care system to domestic or
p.000539: sexual violence in clinical and public health settings, hospitals, clinics, and other health settings
p.000539: (including be- havioral and mental health), under subsection (a)(3) through—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: (a) shall include—
p.000541: (i) documentation that the applicant represents a team of entities working collaboratively to strengthen
p.000541: the response of the health care system to domestic vio- lence, dating violence, sexual assault, or stalking, and which
p.000541: includes at least one of each of—
p.000541: (I) an accredited school of allopathic or osteo- pathic medicine, psychology, nursing, dentistry, social
p.000541: work, or other health field;
p.000541: (II) a health care facility or system; or
p.000541: (III) a government or nonprofit entity with a history of effective work in the fields of domestic
p.000541: violence, dating violence, sexual assault, or stalk- ing; and
p.000541: (ii) strategies for the dissemination and sharing of curricula and other educational materials developed under
p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
p.000541: nonprofit victim advocacy organizations, State or trib- al law enforcement task forces (where appropriate), and
p.000541: population specific organizations with dem- onstrated expertise in domestic violence, dating vio-
p.000541: lence, sexual assault, or stalking;
p.000541: (iv) with respect to an application for a grant under which the grantee will have contact with pa-
p.000541: tients, a plan, developed in collaboration with local victim service providers, to respond appropriately
p.000541: to and make correct referrals for individuals who disclose that they are victims of domestic violence, dating
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p.000543: violence, sexual assault, stalking, and adult health out- comes, including how to reduce or prevent the
p.000543: impact of adverse childhood experiences through the health care set- ting.
p.000543: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000543: $10,000,000 for each of fiscal years 2014 through 2018.
p.000543: (h) DEFINITIONS.—Except as otherwise provided herein, the definitions provided for in section 40002 of the
p.000543: Violence Against Women Act of 1994 shall apply to this section.
p.000543: SEC. 399Q. ø280g–4¿ PUBLIC AND HEALTH CARE PROVIDER EDU- CATION AND SUPPORT SERVICES.
p.000543: (a) IN GENERAL.—The Secretary, directly or through the awarding of grants to public or private nonprofit
p.000543: entities, may con- duct activities, which may include demonstration projects for the purpose of improving
p.000543: the provision of information on prematurity to health professionals and other health care providers and
p.000543: the public and improving the treatment and outcomes mothers of in- fants born preterm, and infants born
p.000543: preterm, as appropriate.
p.000543: (b) ACTIVITIES.—Activities to be carried out under subsection
p.000543: (a) may include the establishment of—
p.000543: (1) programs, including those to test and evaluate strate- gies, which, in collaboration with States,
p.000543: localities, tribes, and community organizations, support the provision of information and education to health
p.000543: professionals, other health care pro- viders, and the public concerning—
p.000543: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000545: PUBLIC HEALTH SERVICE ACT
p.000545: Sec. 399R
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p.000545: ery;
p.000545: (A) the core risk factors for preterm labor and deliv-
p.000545: (B) evidence-based strategies to prevent preterm birth
p.000545: and associated outcomes;
p.000545: (C) medically indicated deliveries before full term, and the risks of non-medically indicated deliveries before
p.000545: full term;
p.000545: (D) the importance of preconception and prenatal care, including—
p.000545: (i) smoking cessation;
p.000545: (ii) weight maintenance and good nutrition, in- cluding folic acid intake;
p.000545: (iii) the screening for and the treatment of infec- tions;
p.000545: (iv) screening for and treatment of substance use disorders;
p.000545: (v) screening for and treatment of maternal de- pression;
p.000545: (vi) maternal immunization; and
p.000545: (vii) stress management;
p.000545: (E) treatments and outcomes for premature infants, including late preterm infants; and
p.000545: (F) the informational needs of families during the stay of an infant in a neonatal intensive care unit.
p.000545: (2) programs to increase the availability, awareness, and use of pregnancy and post-term information
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p.000549: (A) to Federal departments and agencies, such as the National Institutes of Health and the Department of
p.000549: Vet- erans Affairs; and
p.000549: (B) to State and local agencies; and
p.000549: (2) identify, build upon, leverage, and coordinate among existing data and surveillance systems, surveys,
p.000549: registries, and other Federal public health infrastructure, wherever prac- ticable.
p.000549: (g) PUBLIC ACCESS.—Subject to subsection (h), the Secretary shall ensure that information and analysis in
p.000549: the National Neuro- logical Conditions Surveillance System are available, as appro- priate, to the public,
p.000549: including researchers.
p.000549: (h) PRIVACY.—The Secretary shall ensure that information and analysis in the National Neurological Conditions
p.000549: Surveillance Sys- tem are made available only to the extent permitted by applicable Federal and State law, and in a
p.000549: manner that protects personal pri- vacy, to the extent required by applicable Federal and State pri- vacy
p.000549: law, at a minimum.
p.000549: (i) REPORTS.—
p.000549: (1) REPORT ON INFORMATION AND ANALYSES.—Not later than 1 year after the date on which any system is
p.000549: established under this section, the Secretary shall submit an interim re- port to the Committee on
p.000549: Health, Education, Labor, and Pen- sions of the Senate and the Committee on Energy and Com- merce of the
p.000549: House of Representatives regarding aggregate in- formation collected pursuant to this section and epidemiolog-
p.000549: ical analyses, as appropriate. Such report shall be posted on the Internet website of the Department of Health
p.000549: and Human Services and shall be updated biennially.
p.000549: (2) IMPLEMENTATION REPORT.—Not later than 4 years after the date of the enactment of this section, the
p.000549: Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall
p.000549: include information on—
p.000549: (A) the development and maintenance of the National Neurological Conditions Surveillance System;
p.000549: (B) the type of information collected and stored in the surveillance system;
p.000549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000551: Sec. 399T
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p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
p.000551: (ii) the expansion and further development of the National Dissemination Center for Children with Dis-
p.000551: abilities, so that such Center can more effectively con- duct outreach to new and expecting parents and pro-
p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
p.000551: (2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ means—
p.000551: (A) a State or a political subdivision of a State;
p.000551: (B) a consortium of 2 or more States or political sub- divisions of States;
p.000551: (C) a territory;
p.000551: (D) a health facility or program operated by or pursu- ant to a contract with or grant from the Indian Health
p.000551: Service; or
p.000551: (E) any other entity with appropriate expertise in pre- natally and postnatally diagnosed conditions (including na-
p.000551: tionally recognized disability groups), as determined by the Secretary.
p.000551: (3) DISTRIBUTION.—In distributing funds under this sub- section, the Secretary shall place an emphasis on funding
p.000551: part- nerships between health care professional groups and dis- ability advocacy organizations.
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p.000551: January 30, 2020
p.000551: 107 So in law. Probably should read ‘‘section 2(1)’’.
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000553: January 30, 2020
p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
...

p.000555: necessary to carry out this section for each of fiscal years 2010 through 2014.
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: Sec. 399V–1 PUBLIC HEALTH SERVICE ACT 556
p.000555: (k) DEFINITIONS.—In this section:
p.000555: (1) COMMUNITY HEALTH WORKER.—The term ‘‘community health worker’’ means an individual who promotes health
p.000555: or nutrition within the community in which the individual re- sides—
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p.000555: (A) by serving as a liaison between communities and healthcare agencies;
p.000555: (B) by providing guidance and social assistance to community residents;
p.000555: (C) by enhancing community residents’ ability to effec- tively communicate with healthcare providers;
p.000555: (D) by providing culturally and linguistically appro- priate health or nutrition education;
p.000555: (E) by advocating for individual and community health;
p.000555: (F) by providing referral and follow-up services or oth- erwise coordinating care; and
p.000555: (G) by proactively identifying and enrolling eligible in- dividuals in Federal, State, local, private or
p.000555: nonprofit health and human services programs.
p.000555: (2) COMMUNITY SETTING.—The term ‘‘community setting’’ means a home or a community organization located in
p.000555: the neighborhood in which a participant in the program under this section resides.
p.000555: (3) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private entity (including a
p.000555: State or public subdivision of a State, a public health department, a free health clinic, a hospital, or
p.000555: a Federally-qualified health center (as defined in section 1861(aa) of the Social Security Act)), or a
p.000555: consortium of any such entities.
p.000555: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ means a community
p.000555: iden- tified by a State—
p.000555: (A) that has a substantial number of individuals who are members of a medically underserved population, as de-
p.000555: fined by section 330(b)(3); and
p.000555: (B) a significant portion of which is a health profes- sional shortage area as designated under section 332.
p.000555: SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
p.000555: (a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
p.000555: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Agency for Healthcare Research and Quality,
p.000555: shall establish a Primary Care Extension Program.
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p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
p.000557: (B) may include entities such as hospital associations, primary care practice-based research networks, health pro-
p.000557: fessional societies, State primary care associations, State licensing boards, organizations with a contract
p.000557: with the Secretary under section 1153 of the Social Security Act, consumer groups, and other appropriate
p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
p.000557: (1) HUB ACTIVITIES.—Hubs established under a grant under subsection (b) shall—
p.000557: (A) submit to the Secretary a plan to coordinate func- tions with quality improvement organizations and area
p.000557: health education centers if such entities are members of the Hub not described in subsection (b)(2)(A);
p.000557: (B) contract with a county- or local-level entity that shall serve as the Primary Care Extension Agency
p.000557: to ad- minister the services described in paragraph (2);
p.000557: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000557:
p.000557: (C) organize and administer grant funds to county- or local-level Primary Care Extension Agencies that serve a
p.000557: catchment area, as determined by the State; and
p.000557: (D) organize State-wide or multistate networks of local-level Primary Care Extension Agencies to
p.000557: share and disseminate information and practices.
p.000557: (2) LOCAL PRIMARY CARE EXTENSION AGENCY ACTIVITIES.—
p.000557: (A) REQUIRED ACTIVITIES.—Primary Care Extension Agencies established by a Hub under paragraph (1) shall—
p.000557: (i) assist primary care providers to implement a patient-centered medical home to improve the accessi- bility,
p.000557: quality, and efficiency of primary care services, including health homes;
p.000557: (ii) develop and support primary care learning communities to enhance the dissemination of research findings for
p.000557: evidence-based practice, assess implemen- tation of practice improvement, share best practices, and involve
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p.000559: direct patient care.
p.000559: (e) REQUIREMENTS ON THE SECRETARY.—In carrying out this section, the Secretary shall consult with the heads
p.000559: of other Federal agencies with demonstrated experience and expertise in health care and preventive medicine, such
p.000559: as the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Adminis- tration, the
p.000559: Health Resources and Services Administration, the Na- tional Institutes of Health, the Office of the National
p.000559: Coordinator for Health Information Technology, the Indian Health Service, the Agricultural Cooperative Extension
p.000559: Service of the Department of Agriculture, and other entities, as the Secretary determines appro- priate.
p.000559: (f) AUTHORIZATION OF APPROPRIATIONS.—To awards grants as provided in subsection (d), there are authorized to be
p.000559: appropriated
p.000559: $120,000,000 for each of fiscal years 2011 and 2012, and such sums as may be necessary to carry out this
p.000559: section for each of fiscal years 2013 through 2014.
p.000559: SEC. 399V–2. ø280g–13¿ NATIONAL CONGENITAL HEART DISEASE RE- SEARCH, SURVEILLANCE, AND AWARENESS.
p.000559: (a) IN GENERAL.—The Secretary shall, as appropriate—
p.000559: (1) enhance and expand research and data collection ef- forts related to congenital heart disease, including to
p.000559: study and track the epidemiology of congenital heart disease to under- stand health outcomes for
p.000559: individuals with congenital heart disease across all ages;
p.000559: (2) conduct activities to improve public awareness of, and education related to, congenital heart disease,
p.000559: including care of individuals with such disease; and
p.000559: (3) award grants to entities to undertake the activities de- scribed in this section.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000559:
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p.000559: Sec. 399V–2 PUBLIC HEALTH SERVICE ACT 560
p.000559:
p.000559: (b) ACTIVITIES.—
p.000559: (1) IN GENERAL.—The Secretary shall carry out activities, including, as appropriate, through a national cohort
p.000559: study and a nationally-representative, population-based surveillance sys- tem, to improve the understanding of the
p.000559: epidemiology of con- genital heart disease in all age groups, with particular atten- tion to—
p.000559: (A) the incidence and prevalence of congenital heart disease in the United States;
p.000559: (B) causation and risk factors associated with, and natural history of, congenital heart disease;
p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000567: Cen- ters of Excellence, in addition to the 5 Centers designated under subsection (a).
p.000567: (c) ACTIVITIES.—Under the leadership of the Director of the Centers for Disease Control and Prevention,
p.000567: each Center of Excel- lence shall be based out of a selected State health department, which shall
p.000567: provide assistance to other regional, State, and local departments of health through activities that include—
p.000567: (1) providing resources, including timely information con- cerning symptoms and tests, for frontline health
p.000567: professionals interviewing individuals as part of routine surveillance and outbreak investigations;
p.000567: (2) providing analysis of the timeliness and effectiveness of foodborne disease surveillance and outbreak response
p.000567: activi- ties;
p.000567: (3) providing training for epidemiological and environ- mental investigation of foodborne illness,
p.000567: including suggestions for streamlining and standardizing the investigation process;
p.000567: (4) establishing fellowships, stipends, and scholarships to train future epidemiological and food-safety leaders
p.000567: and to ad- dress critical workforce shortages;
p.000567: (5) training and coordinating State and local personnel;
p.000567: (6) strengthening capacity to participate in existing or new foodborne illness surveillance and environmental
p.000567: assessment information systems; and
p.000567: (7) conducting research and outreach activities focused on increasing prevention, communication, and
p.000567: education regard- ing food safety.
p.000567: (d) REPORT TO CONGRESS.—Not later than 2 years after the date of enactment of the FDA Food Safety
p.000567: Modernization Act, the Secretary shall submit to Congress a report that—
p.000567: (1) describes the effectiveness of the Centers of Excellence;
p.000567:
p.000567:
p.000567: January 30, 2020
p.000567: and
p.000567:
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
...

p.000569: (1) SECRETARY DISCRETION.—The Secretary—
p.000569: (A) in consultation with representatives of the relevant State and local health departments, shall consider whether it
p.000569: is appropriate to conduct an investigation of a potential cancer cluster; and
p.000569: (B) in conducting investigations shall have the discre- tion to prioritize certain potential cancer clusters, based on
p.000569: the availability of resources.
p.000569: (2) COORDINATION.—In investigating potential cancer clus- ters, the Secretary shall coordinate with agencies
p.000569: within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection
p.000569: Agency.
p.000569: (3) BIOMONITORING.—In investigating potential cancer clusters, the Secretary shall rely on all
p.000569: appropriate biomoni- toring information collected under other Federal programs, such as the National Health
p.000569: and Nutrition Examination Sur- vey. The Secretary may provide technical assistance for rel- evant
p.000569: biomonitoring studies of other Federal agencies.
p.000569: (e) DUTIES.—The Secretary shall—
p.000569: (1) ensure that appropriate staff of agencies within the De- partment of Health and Human Services are prepared
p.000569: to pro- vide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer
p.000569: cluster from a State or local health authority;
p.000569: (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer
p.000569: surveillance, exposure assessment, pediatric health, pollution control, com- munity outreach, health
p.000569: education, laboratory sampling and analysis, spatial mapping, and informatics;
p.000569: (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary
p.000569: deter- mines appropriate;
p.000569: (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes
p.000569: of such clus- ters, and the actions taken to address such clusters; and
p.000569: (5) provide technical assistance for investigating cancer clusters to State and local health departments through
p.000569: existing programs, such as the Epi-Aids program of the Centers for Dis- ease Control and Prevention and the Assessments
p.000569: of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry.
p.000569:
p.000569:
p.000569:
p.000569:
p.000569: January 30, 2020 As Amended Through P.L. 116-94,
p.000569: Enacted December 20, 2019
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p.000569: Sec. 399W PUBLIC HEALTH SERVICE ACT
p.000569:
p.000569: PART Q—PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
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p.000571: PUBLIC HEALTH SERVICE ACT
p.000571: Sec. 399Y
p.000571:
p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
p.000571: (4) conduct research to establish the prevalence, con- sequences, and costs of childhood obesity
p.000571: and its effects in adulthood;
p.000571: (5) identify behaviors and risk factors that contribute to obesity;
p.000571: (6) evaluate materials and programs to provide nutrition education to parents and teachers of children in
p.000571: child care or pre-school and the food service staff of such child care and pre- school entities; and
p.000571: (7) evaluate materials and programs that are designed to educate and encourage physical activity in child
p.000571: care and pre- school facilities.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Y. ø280h–2¿ EDUCATION CAMPAIGN.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000571: and in collabora- tion with national, State, and local partners, physical activity orga- nizations, nutrition
p.000571: experts, and health professional organizations, shall develop a national public campaign to promote and
p.000571: educate children and their parents concerning—
p.000571: (1) the health risks associated with obesity, inactivity, and poor nutrition;
p.000571: (2) ways in which to incorporate physical activity into daily living; and
p.000571: (3) the benefits of good nutrition and strategies to improve eating habits.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571:
p.000571: January 30, 2020 As Amended Through P.L. 116-94,
p.000571: Enacted December 20, 2019
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p.000571: Sec. 399Z PUBLIC HEALTH SERVICE ACT 572
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p.000571: January 30, 2020
p.000571:
p.000571: SEC. 399Z. ø280h–3¿ HEALTH PROFESSIONAL EDUCATION AND TRAIN- ING.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, in
p.000571: collaboration with the Administrator of the Health Resources and Services Ad- ministration and the heads
p.000571: of other agencies, and in consultation with appropriate health professional associations, shall develop and carry
p.000571: out a program to educate and train health professionals in effective strategies to—
p.000571: (1) better identify and assess patients with obesity or an eating disorder or patients at-risk of
p.000571: becoming obese or devel- oping an eating disorder;
p.000571: (2) counsel, refer, or treat patients with obesity or an eat- ing disorder; and
p.000571: (3) educate patients and their families about effective strategies to improve dietary habits and
p.000571: establish appropriate levels of physical activity.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
p.000571: (a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
p.000571: (1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘‘comprehensive primary health services’’ means the core
p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
...

p.000573: laborative relationships with other health care pro- viders in the catchment area of the SBHC;
p.000573: (iii) the SBHC will provide on-site access during the academic day when school is in session and 24-
p.000573: hour coverage through an on-call system and through its backup health providers to ensure access to
p.000573: serv- ices on a year-round basis when the school or the SBHC is closed;
p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
p.000573: school personnel, such as administrators, teachers, nurses, counselors, and support personnel, as well
p.000573: as with other community providers co-located at the school;
p.000573: (v) the SBHC sponsoring facility assumes all re- sponsibility for the SBHC administration, operations, and
p.000573: oversight; and
p.000573: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000573: Sec. 399Z–1 PUBLIC HEALTH SERVICE ACT 574
p.000573:
p.000573: (vi) the SBHC will comply with Federal, State, and local laws concerning patient privacy and student records,
p.000573: including regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 and
p.000573: section 444 of the General Education Provi- sions Act; and
p.000573: (D) such other information as the Secretary may re- quire.
p.000573: (d) PREFERENCES AND CONSIDERATION.—In reviewing applica- tions:
p.000573: (1) The Secretary may give preference to applicants who demonstrate an ability to serve the following:
p.000573: (A) Communities that have evidenced barriers to pri- mary health care and mental health and substance
p.000573: use disorder prevention services for children and adolescents.
p.000573: (B) Communities with high per capita numbers of chil- dren and adolescents who are uninsured, underinsured, or enrolled
p.000573: in public health insurance programs.
p.000573: (C) Populations of children and adolescents that have historically demonstrated difficulty in accessing health
p.000573: and mental health and substance use disorder prevention serv- ices.
p.000573: (2) The Secretary may give consideration to whether an applicant has received a grant under subsection
p.000573: (a) of section 4101 of the Patient Protection and Affordable Care Act.
p.000573: (e) WAIVER OF REQUIREMENTS.—The Secretary may—
p.000573: (1) under appropriate circumstances, waive the application of all or part of the requirements of this
p.000573: subsection with re- spect to an SBHC for not to exceed 2 years; and
p.000573: (2) upon a showing of good cause, waive the requirement that the SBHC provide all required comprehensive
p.000573: primary health services for a designated period of time to be deter- mined by the Secretary.
p.000573: (f) USE OF FUNDS.—
...

p.000575: (d) USE OF FUNDS FOR EARLY INTERVENTION AND TREATMENT PROGRAMS.—An eligible entity may use amounts awarded
p.000575: under a grant under subsection (a)(1) to carry out the following:
p.000575: (1) Provide age-appropriate mental health promotion and early intervention services or mental illness
p.000575: treatment serv- ices, which may include specialized programs, for eligible chil- dren at significant risk of
p.000575: developing, showing early signs of, or having been diagnosed with a mental illness, including a se- rious
p.000575: emotional disturbance. Such services may include social and behavioral services as well as
p.000575: multigenerational therapy and other services that support the caregiving relationship.
p.000575: (2) Provide training for health care professionals with ex- pertise in infant and early childhood mental
p.000575: health care with respect to appropriate and relevant integration with other dis- ciplines such as primary care
p.000575: clinicians, early intervention spe- cialists, child welfare staff, home visitors, early care and edu- cation
p.000575: providers, and others who work with young children and families.
p.000575: (3) Provide mental health consultation to personnel of early care and education programs (including licensed or
p.000575: regu- lated center-based and home-based child care, home visiting, preschool special education, and early
p.000575: intervention programs) who work with children and families.
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: PUBLIC HEALTH SERVICE ACT
p.000577: Sec. 399AA
p.000577:
p.000577: (4) Provide training for mental health clinicians in infant and early childhood in promising and evidence-based
p.000577: practices and models for infant and early childhood mental health treat- ment and early intervention, including with
p.000577: regard to practices for identifying and treating mental illness and behavioral dis- orders of infants and
p.000577: children resulting from exposure or re- peated exposure to adverse childhood experiences or childhood trauma.
p.000577: (5) Provide age-appropriate assessment, diagnostic, and intervention services for eligible children, including
p.000577: early men- tal health promotion, intervention, and treatment services.
p.000577: (e) MATCHING FUNDS.—The Secretary may not award a grant under this section to an eligible entity unless
...

p.000577: (2) REQUIREMENTS.—To be eligible to receive a grant or co- operative agreement under paragraph (1), an entity shall
p.000577: sub- mit to the Secretary an application containing such agreements and information as the Secretary may require,
p.000577: including an agreement that the center to be established or supported under the grant or cooperative agreement shall
p.000577: operate in accordance with the following:
p.000577: (A) The center will collect, analyze, and report autism spectrum disorder and other developmental disability data
p.000577: according to guidelines prescribed by the Director of the Centers for Disease Control and Prevention,
p.000577: after con- sultation with State, local, and Tribal public health offi- cials, private sector developmental
p.000577: disability researchers, advocates for individuals with autism spectrum disorder, and advocates for
p.000577: individuals with other developmental disabilities.
p.000577: (B) The center will develop or extend an area of spe- cial research expertise (including genetics,
p.000577: epigenetics, and epidemiological research related to environmental expo- sures), immunology, and other
p.000577: relevant research specialty areas.
p.000577: (C) The center will identify eligible cases and controls through its surveillance system and conduct research
p.000577: into factors which may cause or increase the risk of autism spectrum disorder and other developmental
p.000577: disabilities.
p.000577: (c) FEDERAL RESPONSE.—The Secretary shall coordinate the Federal response to requests for assistance from State
p.000577: health, men- tal health, and education department officials regarding potential or alleged autism spectrum
p.000577: disorder or developmental disability clusters.
p.000577: (d) DEFINITIONS.—In this part:
p.000577: (1) INDIAN TRIBE; TRIBAL ORGANIZATION.—The terms ‘‘In- dian tribe’’ and ‘‘tribal organization’’ have the
p.000577: meanings given such terms in section 4 of the Indian Health Care Improve- ment Act.
p.000577: (2) OTHER DEVELOPMENTAL DISABILITIES.—The term ‘‘other developmental disabilities’’ has the meaning given the
p.000577: term ‘‘developmental disability’’ in section 102(8) of the Develop- mental Disabilities Assistance and Bill
p.000577: of Rights Act of 2000 (42 U.S.C. 15002(8)).
p.000577: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000577: Puerto Rico, American Samoa, Guam, the Commonwealth of the
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: PUBLIC HEALTH SERVICE ACT
p.000579: Sec. 399BB
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p.000579: January 30, 2020
p.000579: Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.
p.000579: (e) SUNSET.—This section shall not apply after September 30, 2024.
p.000579: SEC. 399BB. ø280i–1¿ AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION.
p.000579: (a) PURPOSE.—It is the purpose of this section—
p.000579: (1) to increase awareness, reduce barriers to screening and diagnosis, promote evidence-based interventions for
p.000579: individuals with autism spectrum disorder and other developmental dis- abilities, and train professionals to
p.000579: utilize valid and reliable screening tools to diagnose or rule out and provide evidence- based
p.000579: interventions for individuals with autism spectrum dis- order and other developmental disabilities across
p.000579: their life- span; and
p.000579: (2) to conduct activities under this section with a focus on an interdisciplinary approach (as defined in
p.000579: programs devel- oped under section 501(a)(2) of the Social Security Act) that will also focus on specific
p.000579: issues for children who are not re- ceiving an early diagnosis and subsequent interventions.
p.000579: (b) IN GENERAL.—The Secretary shall, subject to the avail- ability of appropriations, establish and evaluate
p.000579: activities to—
p.000579: (1) provide culturally competent information and education on autism spectrum disorder and other developmental
p.000579: disabil- ities to increase public awareness of developmental milestones;
p.000579: (2) promote research into the development and validation of reliable screening tools for individuals with autism
p.000579: spectrum disorder and other developmental disabilities and disseminate information regarding those screening
p.000579: tools;
p.000579: (3) promote early screening of individuals at higher risk for autism spectrum disorder and other developmental
p.000579: disabil- ities as early as practicable, given evidence-based screening techniques and interventions;
p.000579: (4) promote evidence-based screening techniques and inter- ventions for individuals with autism spectrum disorder
p.000579: and other developmental disabilities across their lifespan;
p.000579: (5) increase the number of individuals who are able to con- firm or rule out a diagnosis of autism spectrum
p.000579: disorder and other developmental disabilities;
p.000579: (6) increase the number of individuals able to provide evi- dence-based interventions for individuals diagnosed
p.000579: with au- tism spectrum disorder or other developmental disabilities; and
p.000579: (7) promote the use of evidence-based interventions for in- dividuals at higher risk for autism spectrum
p.000579: disorder and other developmental disabilities as early as practicable.
p.000579: (c) INFORMATION AND EDUCATION.—
p.000579: (1) IN GENERAL.—In carrying out subsection (b)(1), the Sec- retary, in collaboration with the Secretary of
p.000579: Education and the Secretary of Agriculture, shall, subject to the availability of appropriations, provide culturally
p.000579: competent information re- garding autism spectrum disorder and other developmental disabilities, risk
p.000579: factors, characteristics, identification, diag- nosis or rule out, and evidence-based interventions to meet the
p.000579: needs of individuals with autism spectrum disorder and other
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: Sec. 399BB PUBLIC HEALTH SERVICE ACT 580
p.000579:
p.000579: developmental disabilities across their lifespan and the needs of their families through—
p.000579: (A) Federal programs, including—
p.000579: (i) the Head Start program;
p.000579: (ii) the Early Start program;
p.000579: (iii) the Healthy Start program;
p.000579: (iv) programs under the Child Care and Develop- ment Block Grant Act of 1990;
p.000579: (v) programs under title XIX of the Social Security Act (particularly the Medicaid Early and Periodic
p.000579: Screening, Diagnosis and Treatment Program);
p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
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p.000581: PUBLIC HEALTH SERVICE ACT
p.000581: Sec. 399BB
p.000581:
p.000581: (I) autism spectrum disorder and other devel- opmental disability issues; and
p.000581: (II) developing, implementing, conducting, and administering programs and delivering edu- cation,
p.000581: information, and referral services (includ- ing technology-based curriculum-development services) to
p.000581: individuals with autism spectrum dis- order and developmental disabilities and their family members,
p.000581: guardians, advocates or author- ized representatives, providers, and other appro- priate individuals locally
p.000581: and across the State; and
p.000581: (ii) consider input from individuals with autism spectrum disorder and developmental disabilities and their
p.000581: family members, guardians, advocates or author- ized representatives, providers, and other appropriate
p.000581: individuals.
p.000581: (C) INFORMATION.—Information under subparagraph (A)(ii) shall be provided through—
p.000581: (i) toll-free telephone numbers;
p.000581: (ii) Internet websites;
p.000581: (iii) mailings; or
p.000581: (iv) such other means as the Governor may re- quire.
p.000581: (d) TOOLS.—
p.000581: (1) IN GENERAL.—To promote the use of valid and reliable screening tools for autism spectrum disorder and other
p.000581: devel- opmental disabilities, the Secretary shall develop a curriculum for continuing education to assist
p.000581: individuals in recognizing the need for valid and reliable screening tools and the use of such tools.
p.000581: (2) COLLECTION, STORAGE, COORDINATION, AND AVAIL- ABILITY.—The Secretary, in collaboration with the
p.000581: Secretary of Education, shall provide for the collection, storage, coordina- tion, and public availability of
p.000581: tools described in paragraph (1), educational materials and other products that are used by the Federal programs
p.000581: referred to in subsection (c)(1)(A), as well as—
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p.000581: (A) programs authorized under the Developmental Disabilities Assistance and Bill of Rights Act of 2000;
p.000581: (B) early intervention programs or interagency coordi- nating councils authorized under part C of the Individuals with
p.000581: Disabilities Education Act; and
p.000581: (C) children with special health care needs programs authorized under title V of the Social Security Act.
p.000581: (3) REQUIRED SHARING.—In establishing mechanisms and entities under this subsection, the Secretary, and the
p.000581: Secretary of Education, shall ensure the sharing of tools, materials, and products developed under this
p.000581: subsection among entities re- ceiving funding under this section.
p.000581: (e) DIAGNOSIS.—
p.000581: (1) TRAINING.—The Secretary, in coordination with activi- ties conducted under title V of the Social
p.000581: Security Act, shall, subject to the availability of appropriations, expand existing
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: Sec. 399BB PUBLIC HEALTH SERVICE ACT 582
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p.000581: interdisciplinary training opportunities or opportunities to in- crease the number of sites able to diagnose or
p.000581: rule out individ- uals with autism spectrum disorder or other developmental disabilities across their lifespan
p.000581: and ensure that—
p.000581: (A) competitive grants or cooperative agreements are awarded to public or nonprofit agencies, including
p.000581: institu- tions of higher education, to expand existing or develop new maternal and child health
p.000581: interdisciplinary leadership education in neurodevelopmental and related disabilities programs (similar to the
p.000581: programs developed under section 501(a)(2) of the Social Security Act) in States that do not have such a
p.000581: program;
p.000581: (B) trainees under such training programs—
p.000581: (i) receive an appropriate balance of academic, clinical, and community opportunities;
p.000581: (ii) are culturally competent;
p.000581: (iii) are ethnically diverse;
p.000581: (iv) demonstrate a capacity to evaluate, diagnose or rule out, develop, and provide evidence-based inter-
p.000581: ventions to individuals with autism spectrum disorder and other developmental disabilities across their life-
p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
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p.000583: Sec. 399CC PUBLIC HEALTH SERVICE ACT 584
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p.000583: (A) the Director of the Centers for Disease Control and Prevention;
p.000583: (B) the Director of the National Institutes of Health, and the Directors of such national research
p.000583: institutes of the National Institutes of Health as the Secretary deter- mines appropriate;
p.000583: (C) the heads of such other agencies as the Secretary determines appropriate, such as the Administration
p.000583: for Community Living, Administration for Children and Fami- lies, the Centers for Medicare & Medicaid Services,
p.000583: the Food and Drug Administration, and the Health Resources and Services Administration; and
p.000583: (D) representatives of other Federal Governmental agencies that serve individuals with autism spectrum
p.000583: dis- order such as the Department of Education, the Depart- ment of Labor, the Department of Justice, the
p.000583: Department of Veterans Affairs, the Department of Housing and Urban Development, and the Department of Defense.
p.000583: (2) NON-FEDERAL MEMBERS.—Not more than 1⁄2, but not fewer than 1⁄3, of the total membership of the Committee,
p.000583: shall be composed of non-Federal public members to be appointed by the Secretary, of which—
p.000583: (A) at least three such members shall be individuals with a diagnosis of autism spectrum disorder;
p.000583: (B) at least three such members shall be parents or legal guardians of an individual with an autism
p.000583: spectrum disorder; and
p.000583: (C) at least three such members shall be representa- tives of leading research, advocacy, and service
p.000583: organiza- tions for individuals with autism spectrum disorder.
p.000583: (3) PERIOD OF APPOINTMENT; VACANCIES.—
p.000583: (A) PERIOD OF APPOINTMENT FOR NON-FEDERAL MEM- BERS.—Non-Federal members shall serve for a term of 4
p.000583: years, and may be reappointed for one additional 4-year term.
p.000583: (B) VACANCIES.—A vacancy on the Committee shall be filled in the manner in which the original appointment was
p.000583: made and shall not affect the powers or duties of the Committee. Any member appointed to fill a vacancy for an
p.000583: unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of
p.000583: the member’s term until a successor has been appointed.
p.000583: (d) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PRO- VISIONS.—The following provisions shall apply with
p.000583: respect to the Committee:
p.000583: (1) The Committee shall receive necessary and appropriate administrative support from the Secretary.
p.000583: (2) The Committee shall meet at the call of the chairperson or upon the request of the Secretary. The Committee
p.000583: shall meet not fewer than 2 times each year.
p.000583: (3) All meetings of the Committee shall be public and shall include appropriate time periods for questions and
p.000583: presen- tations by the public.
p.000583: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000585: PUBLIC HEALTH SERVICE ACT
p.000585: Sec. 399DD
p.000585:
p.000585: (e) SUBCOMMITTEES; ESTABLISHMENT AND MEMBERSHIP.—In carrying out its functions, the Committee may
p.000585: establish sub- committees and convene workshops and conferences. Such sub- committees shall be composed
p.000585: of Committee members and may hold such meetings as are necessary to enable the subcommittees to carry out
p.000585: their duties.
p.000585: (f) SUNSET.—This section shall not apply after September 30, 2024, and the Committee shall be terminated on
p.000585: such date.
p.000585: SEC. 399DD. ø280i–3¿ REPORTS TO CONGRESS.
p.000585: (a) PROGRESS REPORT.—
p.000585: (1) IN GENERAL.— 108Not later than 4 years after the date of enactment of the Autism CARES Act of 2019, the Secretary,
p.000585: in coordination with the Secretary of Education and the Sec- retary of Defense, shall prepare and submit
p.000585: to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce
p.000585: Committee of the House of Rep- resentatives, and make publicly available, including through posting on the
p.000585: Internet Web site of the Department of Health and Human Services, a progress report on activities related to
p.000585: autism spectrum disorder and other developmental disabilities.
p.000585: (2) CONTENTS.—The report submitted under subsection (a) shall contain—
p.000585: (A) a description of the progress made in imple- menting the provisions of the Autism CARES Act of
p.000585: 2019;
p.000585: (B) a description of the amounts expended on the im- plementation of the amendments made by the Autism
p.000585: CARES Act of 2019;
p.000585: (C) information on the incidence and prevalence of au- tism spectrum disorder, including available information on the
p.000585: prevalence of autism spectrum disorder among chil- dren and adults, and identification of any changes
p.000585: over time with respect to the incidence and prevalence of au- tism spectrum disorder;
p.000585: (D) information on the average age of diagnosis for children with autism spectrum disorder and other
p.000585: disabil- ities, including how that age may have changed over the 4-year period beginning on the date of
p.000585: enactment of the Autism CARES Act of 2019 and, as appropriate, how this age varies across population
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p.000585: ty agencies or the criminal justice system for such in- dividuals; and
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000587: PUBLIC HEALTH SERVICE ACT
p.000587: Sec. 399HH
p.000587:
p.000587: (E) recommendations that seek to improve health out- comes for such individuals, including across their lifespan, by
p.000587: addressing—
p.000587: (i) screening and diagnosis of children and adults;
p.000587: (ii) behavioral and other therapeutic approaches;
p.000587: (iii) primary and preventative care;
p.000587: (iv) communication challenges;
p.000587: (v) aggression, self-injury, elopement, and other behavioral issues;
p.000587: (vi) emergency room visits and acute care hos- pitalization;
p.000587: (vii) treatment for co-occurring physical and men- tal health conditions;
p.000587: (viii) premature mortality;
p.000587: (ix) medical practitioner training; and
p.000587: (x) caregiver mental health.
p.000587: SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000587: (a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RE- SEARCH PROGRAM.—To carry out section 399AA, there is
p.000587: authorized to be appropriated $23,100,000 for each of fiscal years 2020 through 2024.
p.000587: (b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVEN- TION.—To carry out section 399BB, there is authorized
p.000587: to be appro- priated $50,599,000 for each of fiscal years 2020 through 2024.
p.000587: (c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN OTHER PROGRAMS.—To carry out sections 399CC and
p.000587: 409C, there are authorized to be appropriated $296,000,000 for each of fiscal years 2020 through 2024.
p.000587: PART S—HEALTH CARE QUALITY PROGRAMS
p.000587: Subpart I—National Strategy for Quality Improvement in Health Care
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p.000587: SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
p.000587: (a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
p.000587: (1) NATIONAL STRATEGY.—The Secretary, through a trans- parent collaborative process, shall establish a national
p.000587: strategy to improve the delivery of health care services, patient health outcomes, and population health.
p.000587: (2) IDENTIFICATION OF PRIORITIES.—
p.000587: (A) IN GENERAL.—The Secretary shall identify national priorities for improvement in developing the strategy
p.000587: under paragraph (1).
p.000587: (B) REQUIREMENTS.—The Secretary shall ensure that priorities identified under subparagraph (A) will—
p.000587: (i) have the greatest potential for improving the health outcomes, efficiency, and patient-centeredness of
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p.000591: SEC. 399KK. ø280j–3¿ QUALITY IMPROVEMENT PROGRAM FOR HOS- PITALS WITH A HIGH SEVERITY ADJUSTED READMISSION RATE.
p.000591: (a) ESTABLISHMENT.—
p.000591: (1) IN GENERAL.—Not later than 2 years after the date of enactment of this section, the Secretary shall
p.000591: make available a program for eligible hospitals to improve their readmission rates through the use of
p.000591: patient safety organizations (as de- fined in section 921(4)).
p.000591: (2) ELIGIBLE HOSPITAL DEFINED.—In this subsection, the term ‘‘eligible hospital’’ means a hospital that the
p.000591: Secretary de- termines has a high rate of risk adjusted readmissions for the conditions described in section
p.000591: 1886(q)(8)(A) of the Social Secu- rity Act and has not taken appropriate steps to reduce such re- admissions and
p.000591: improve patient safety as evidenced through historically high rates of readmissions, as determined by the
p.000591: Secretary.
p.000591: (3) RISK ADJUSTMENT.—The Secretary shall utilize appro- priate risk adjustment measures to determine
p.000591: eligible hos- pitals.
p.000591: (b) REPORT TO THE SECRETARY.—As determined appropriate by the Secretary, eligible hospitals and patient
p.000591: safety organizations working with those hospitals shall report to the Secretary on the processes employed
p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
p.000593: (1) IN GENERAL.—The Secretary, in consultation with the Director of the Centers for Disease Control and
p.000593: Prevention and the Administrator of the Health Resources and Services Ad- ministration, may award grants,
p.000593: contracts, or cooperative agreements to eligible entities to collaborate with State or local public health
p.000593: officials, tribal health officials, oral health profes- sional organizations, and others, as appropriate, to develop
p.000593: and implement initiatives to improve oral health, including activi- ties to prevent dental disease and reduce
p.000593: barriers to the provi- sion of dental services, including—
p.000593: (A) through community-wide dental disease prevention programs; and
p.000593: (B) by increasing public awareness and education re- lated to oral health and dental disease prevention.
p.000593: (2) ELIGIBLE ENTITIES.—To be eligible to receive a grant, contract, or cooperative agreement under this
p.000593: subsection, an entity shall be—
p.000593: (A) a dental association;
p.000593: (B) a State or tribal health department or State or tribal oral health program;
p.000593: (C) an accredited dental education, dental hygiene, or postdoctoral dental education program; or
p.000593: (D) a non-profit community-based organization that partners with public and private non-profit entities,
p.000593: such as an academic institution, to facilitate the provision of dental services to underserved populations.
p.000593: SEC. 399LL–1. ø280k–1¿ RESEARCH-BASED DENTAL CARIES DISEASE MANAGEMENT.
p.000593: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000593: shall award dem- onstration grants to eligible entities to demonstrate the effective- ness of research-based
p.000593: dental caries disease management activities.
p.000593: (b) ELIGIBILITY.—To be eligible for a grant under this section, an entity shall—
p.000593: (1) be a community-based provider of dental services (as defined by the Secretary), including a
p.000593: Federally-qualified health center, a clinic of a hospital owned or operated by a State (or by an
p.000593: instrumentality or a unit of government within a State), a State or local department of health, a dental
p.000593: pro- gram of the Indian Health Service, an Indian tribe or tribal or- ganization, or an urban Indian organization (as
p.000593: such terms are defined in section 4 of the Indian Health Care Improvement Act), a health system provider,
p.000593: a private provider of dental services, medical, dental, public health, nursing, nutrition edu- cational
p.000593: institutions, or national organizations involved in im- proving children’s oral health; and
p.000593: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000593: Sec- retary may require.
p.000593: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: Sec. 399NN
p.000595:
p.000595: (b) REPORT.—Upon the completion of each study under sub- section (a), the Director shall submit to Congress a
p.000595: report that in- cludes the recommendations of the Director for the implementation of effective employer-based health
p.000595: policies and programs.
p.000595: SEC. 399MM–2. ø280l–2¿ PRIORITIZATION OF EVALUATION BY SEC- RETARY.
p.000595: The Secretary shall evaluate, in accordance with this part, all programs funded through the Centers for
p.000595: Disease Control and Pre- vention before conducting such an evaluation of privately funded programs unless an
p.000595: entity with a privately funded wellness pro- gram requests such an evaluation.
p.000595: SEC. 399MM–3. ø280l–3¿ PROHIBITION OF FEDERAL WORKPLACE WELLNESS REQUIREMENTS.
p.000595: Notwithstanding any other provision of this part, any rec- ommendations, data, or assessments carried out
p.000595: under this part shall not be used to mandate requirements for workplace wellness programs.
p.000595:
p.000595: PART V—PROGRAMS RELATING TO BREAST HEALTH AND CANCER
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p.000595: January 30, 2020
p.000595: SEC. 399NN. ø280m¿ YOUNG WOMEN’S BREAST HEALTH AWARENESS AND SUPPORT OF YOUNG WOMEN DIAGNOSED WITH
p.000595: BREAST CANCER.
p.000595: (a) PUBLIC EDUCATION CAMPAIGN.—
p.000595: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000595: shall conduct a national evidence-based education campaign to in- crease awareness of young women’s knowledge
p.000595: regarding—
p.000595: (A) breast health in young women of all racial, ethnic, and cultural backgrounds;
p.000595: (B) breast awareness and good breast health habits;
p.000595: (C) the occurrence of breast cancer and the general and specific risk factors in women who may be at high risk
p.000595: for breast cancer based on familial, racial, ethnic, and cul- tural backgrounds such as Ashkenazi Jewish
p.000595: populations;
p.000595: (D) evidence-based information that would encourage young women and their health care professional to in-
p.000595: crease early detection of breast cancers; and
p.000595: (E) the availability of health information and other re- sources for young women diagnosed with breast cancer.
p.000595: (2) EVIDENCE-BASED, AGE APPROPRIATE MESSAGES.—The campaign shall provide evidence-based, age-appropriate
p.000595: mes- sages and materials as developed by the Centers for Disease Control and Prevention and the Advisory
p.000595: Committee estab- lished under paragraph (4).
p.000595: (3) MEDIA CAMPAIGN.—In conducting the education cam- paign under paragraph (1), the Secretary shall award grants
p.000595: to entities to establish national multimedia campaigns oriented to young women that may include advertising through
p.000595: television, radio, print media, billboards, posters, all forms of existing and especially emerging social networking
p.000595: media, other Internet
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: Sec. 399NN PUBLIC HEALTH SERVICE ACT 596
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p.000595: January 30, 2020
p.000595:
p.000595: media, and any other medium determined appropriate by the Secretary.
p.000595: (4) ADVISORY COMMITTEE.—
p.000595: (A) ESTABLISHMENT.—Not later than 60 days after the date of the enactment of this section, the Secretary, acting
p.000595: through the Director of the Centers for Disease Control and Prevention, shall establish an advisory
p.000595: committee to assist in creating and conducting the education campaigns under paragraph (1) and subsection (b)(1).
p.000595: (B) MEMBERSHIP.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000595: tion, shall appoint to the advisory committee under sub- paragraph (A) such members as deemed necessary to
p.000595: prop- erly advise the Secretary, and shall include organizations and individuals with expertise in breast
p.000595: cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and
p.000595: counseling, treatment, rehabilitation, palliative care, and survivorship in young women.
p.000595: (b) HEALTH CARE PROFESSIONAL EDUCATION CAMPAIGN.—The Secretary, acting through the Director of the Centers
p.000595: for Disease Control and Prevention, and in consultation with the Administrator of the Health Resources and Services
p.000595: Administration, shall conduct an education campaign among physicians and other health care professionals to
p.000595: increase awareness—
p.000595: (1) of breast health, symptoms, and early diagnosis and treatment of breast cancer in young women,
p.000595: including specific risk factors such as family history of cancer and women that may be at high risk for
p.000595: breast cancer, such as Ashkenazi Jew- ish population;
p.000595: (2) on how to provide counseling to young women about their breast health, including knowledge of their family
p.000595: cancer history and importance of providing regular clinical breast ex- aminations;
p.000595: (3) concerning the importance of discussing healthy behav- iors, and increasing awareness of services and programs
p.000595: avail- able to address overall health and wellness, and making pa- tient referrals to address tobacco
p.000595: cessation, good nutrition, and physical activity;
p.000595: (4) on when to refer patients to a health care provider with genetics expertise;
p.000595: (5) on how to provide counseling that addresses long-term survivorship and health concerns of young women
p.000595: diagnosed with breast cancer; and
p.000595: (6) on when to provide referrals to organizations and insti- tutions that provide credible health information
...

p.000597: public, targeted populations, and their families about breast health, breast cancer, and healthy
p.000597: lifestyles;
p.000597: (C) testing and evaluating existing and new social marketing strategies targeted at young women; and
p.000597: (D) surveys of health care providers and the public re- garding knowledge, attitudes, and practices related
p.000597: to breast health and breast cancer prevention and control in high-risk populations; and
p.000597: (2) the Director of the National Institutes of Health, shall conduct research to develop and validate
p.000597: new screening tests and methods for prevention and early detection of breast can- cer in young women.
p.000597: (d) SUPPORT FOR YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.—
p.000597: (1) IN GENERAL.—The Secretary shall award grants to or- ganizations and institutions to provide health
p.000597: information from credible sources and substantive assistance directed to young women diagnosed with breast
p.000597: cancer and pre-neoplastic breast diseases.
p.000597: (2) PRIORITY.—In making grants under paragraph (1), the Secretary shall give priority to applicants that deal
p.000597: specifically with young women diagnosed with breast cancer and pre-neo- plastic breast disease.
p.000597: (e) NO DUPLICATION OF EFFORT.—In conducting an education campaign or other program under subsections (a),
p.000597: (b), (c), or (d), the Secretary shall avoid duplicating other existing Federal breast cancer education efforts.
p.000597: (f) MEASUREMENT; REPORTING.—The Secretary, acting through the Director of the Centers for Disease
p.000597: Control and Prevention, shall—
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p.000597: January 30, 2020
p.000597: (1) measure—
p.000597: (A) young women’s awareness regarding breast health, including knowledge of family cancer history, specific risk
p.000597: factors and early warning signs, and young women’s proactive efforts at early detection;
p.000597: (B) the number or percentage of young women uti- lizing information regarding lifestyle interventions that
p.000597: foster healthy behaviors;
p.000597: (C) the number or percentage of young women receiv- ing regular clinical breast exams; and
p.000597: (D) the number or percentage of young women who perform breast self exams, and the frequency of
p.000597: such exams, before the implementation of this section;
p.000597: (2) not less than every 3 years, measure the impact of such activities; and
p.000597: (3) submit reports to the Congress on the results of such measurements.
...

p.000597: (5) The National Institute on Aging.
p.000597: (6) The National Institute of Allergy and Infectious Dis- eases.
p.000597: (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000597: (8) The National Institute of Dental and Craniofacial Re- search. 2
p.000597: (9) The National Eye Institute.
p.000597: (10) The National Institute of Neurological Disorders and Stroke.
p.000597: (11) The National Institute on Deafness and Other Com- munication Disorders.
p.000597: (12) The National Institute on Alcohol Abuse and Alco- holism.
p.000597: (13) The National Institute on Drug Abuse.
p.000597: (14) The National Institute of Mental Health.
p.000597: (15) The National Institute of General Medical Sciences.
p.000597: (16) The National Institute of Environmental Health Sciences.
p.000597: (17) The National Institute of Nursing Research.
p.000597: (18) The National Institute of Biomedical Imaging and Bio- engineering.
p.000597: (19) The National Human Genome Research Institute.
p.000597: (20) The National Library of Medicine.
p.000597: (21) The National Center for Advancing Translational Sciences.
p.000597: (22) The John E. Fogarty International Center for Ad- vanced Study in the Health Sciences.
p.000597:
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p.000597: January 30, 2020
p.000597: 1 See footnote for section 202.
p.000597: 2 Section 212 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies
p.000597: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–359)
p.000597: amended subparagraph (H) to read as provided above, there- by indicating the intent of the Congress to change the
p.000597: designation of the Institute. (The former designation was the National Institute of Dental Research.) Conforming
p.000597: changes were not, how- ever, made to section 453 or the related subpart heading, or to the reference in section
p.000597: 409A(a).
p.000597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000599: PUBLIC HEALTH SERVICE ACT
p.000599: Sec. 401
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p.000599: January 30, 2020
p.000599: (23) The National Center for Complementary and Integra- tive Health.
p.000599: (24) The National Institute on Minority Health and Health Disparities.
...

p.000599: na- tional research institutes to conduct and support research, training, health information, and other programs
p.000599: with re- spect to any particular disease or groups of diseases or any other aspect of human health if—
p.000599: (i) the Secretary determines that an additional in- stitute is necessary to carry out such activities; and
p.000599: (ii) the additional institute is not established be- fore the expiration of 180 days after the Secretary has
p.000599: provided the Committee on Energy and Commerce of
p.000599: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000599: Sec. 401 PUBLIC HEALTH SERVICE ACT 600
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p.000599: January 30, 2020
p.000599:
p.000599: the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate
p.000599: written notice of the determination made under clause
p.000599: (i) with respect to the institute.
p.000599: (B) ADDITIONAL AUTHORITY.—The Secretary may reor- ganize the functions of any national research institute and may
p.000599: abolish any national research institute if the Sec- retary determines that the institute is no longer required.
p.000599: A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after
p.000599: the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and
p.000599: the Com- mittee on Health, Education, Labor, and Pensions of the Senate written notice of the reorganization
p.000599: or abolition.
p.000599: (3) REORGANIZATION OF OFFICE OF DIRECTOR.—Notwith- standing subsection (c), the Director of NIH may, after a
p.000599: series of public hearings, and with the approval of the Secretary, re- organize the offices within the Office of the
p.000599: Director, including the addition, removal, or transfer of functions of such offices, and the establishment or
p.000599: termination of such offices, if the Di- rector determines that the overall management and operation of programs
p.000599: and activities conducted or supported by such of- fices would be more efficiently carried out under such a
p.000599: reorga- nization.
p.000599: (4) INTERNAL REORGANIZATION OF INSTITUTES AND CEN- TERS.—Notwithstanding any conflicting provisions of this
p.000599: title, the director of a national research institute or a national cen- ter may, after a series of public
p.000599: hearings and with the approval of the Director of NIH, reorganize the divisions, centers, or other
p.000599: administrative units within such institute or center, in- cluding the addition, removal, or transfer of
p.000599: functions of such units, and the establishment or termination of such units, if the director of such
p.000599: institute or center determines that the overall management and operation of programs and activities
p.000599: conducted or supported by such divisions, centers, or other units would be more efficiently carried out
p.000599: under such a reor- ganization.
p.000599: (e) SCIENTIFIC MANAGEMENT REVIEW BOARD FOR PERIODIC OR-
p.000599: GANIZATIONAL REVIEWS.—
p.000599: (1) IN GENERAL.—Not later than 60 days after the date of the enactment of the National Institutes of Health
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p.000601: Sec. 401 PUBLIC HEALTH SERVICE ACT 602
p.000601:
p.000601: (A) Not fewer than 9 officials who are directors of na- tional research institutes or national centers. The Sec-
p.000601: retary shall designate such officials for membership and shall ensure that the group of officials so
p.000601: designated in- cludes directors of—
p.000601: (i) national research institutes whose budgets are substantial relative to a majority of the other insti-
p.000601: tutes;
p.000601: (ii) national research institutes whose budgets are small relative to a majority of the other institutes;
p.000601: (iii) national research institutes that have been in existence for a substantial period of time without sig-
p.000601: nificant organizational change under subsection (d);
p.000601: (iv) as applicable, national research institutes that have undergone significant organization changes under
p.000601: such subsection, or that have been established under such subsection, other than national research
p.000601: institutes for which such changes have been in place for a substantial period of time; and
p.000601: (v) national centers.
p.000601: (B) Members appointed by the Secretary from among individuals who are not officers or employees of the United
p.000601: States. Such members shall include—
p.000601: (i) individuals representing the interests of public or private institutions of higher education that have
p.000601: historically received funds from NIH to conduct re- search; and
p.000601: (ii) individuals representing the interests of pri- vate entities that have received funds from NIH to
p.000601: conduct research or that have broad expertise regard- ing how the National Institutes of Health
p.000601: functions, exclusive of private entities to which clause (i) applies.
p.000601: (4) CHAIR.—The Chair of the Board shall be selected by the Secretary from among the members of the Board
p.000601: appointed under paragraph (3)(B). The term of office of the Chair shall be 2 years.
p.000601: (5) MEETINGS.—
p.000601: (A) IN GENERAL.—The Board shall meet at the call of the Chair or upon the request of the Director of NIH, but
p.000601: not fewer than 5 times with respect to issuing any par- ticular report under paragraph (2)(A). The
p.000601: location of the meetings of the Board is subject to the approval of the Di- rector of NIH.
p.000601: (B) PARTICULAR FORUMS.—Of the meetings held under subparagraph (A) with respect to a report under para- graph
p.000601: (2)(A)—
p.000601: (i) one or more shall be directed toward the sci- entific community to address scientific needs and op-
p.000601: portunities related to proposals for organizational changes under subsection (d), or as the case may
p.000601: be, related to a proposal that no such changes be made; and
p.000601:
p.000601:
p.000601:
p.000601: January 30, 2020
p.000601: (ii) one or more shall be directed toward consumer organizations to address the needs and opportunities
p.000601: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000601:
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p.000603: 603
p.000603: PUBLIC HEALTH SERVICE ACT
p.000603: Sec. 401
p.000603:
p.000603: of patients and their families with respect to proposals referred to in clause (i).
p.000603: (C) AVAILABILITY OF INFORMATION FROM FORUMS.—For each meeting under subparagraph (B), the Director of NIH shall
p.000603: post on the Internet site of the National Institutes of Health a summary of the proceedings.
p.000603: (6) COMPENSATION; TERM OF OFFICE.—The provisions of subsections (b)(4) and (c) of section 406 apply
p.000603: with respect to the Board to the same extent and in the same manner as such provisions apply with respect to an
p.000603: advisory council referred to in such subsections, except that the reference in such sub- section (c) to 4
p.000603: years regarding the term of an appointed mem- ber is deemed to be a reference to 5 years.
p.000603: (7) REPORTS.—
p.000603: (A) RECOMMENDATIONS FOR CHANGES.—Each report under paragraph (2)(A) shall be submitted to—
p.000603: (i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Rep- resentatives;
p.000603: (ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate;
p.000603: (iii) the Secretary; and
p.000603: (iv) officials with organizational authorities, other than any such official who served as a member of the Board
p.000603: with respect to the report involved.
p.000603: (B) AVAILABILITY TO PUBLIC.—The Director of NIH shall post each report under paragraph (2) on the Internet site
p.000603: of the National Institutes of Health.
p.000603: (C) REPORT ON BOARD ACTIVITIES.—Not later than 18 months after the date of the enactment of the National In-
p.000603: stitutes of Health Reform Act of 2006, the Board shall sub- mit to the committees specified in subparagraph (A)
p.000603: a re- port describing the activities of the Board.
p.000603: (f) ORGANIZATIONAL CHANGES PER RECOMMENDATION OF SCI-
p.000603: ENTIFIC MANAGEMENT REVIEW BOARD.—
p.000603: (1) IN GENERAL.—With respect to an official who has orga- nizational authorities within the meaning of
p.000603: subsection (e)(2)(A), if a recommendation to the official for an organiza- tional change is made in a
p.000603: report under such subsection, the official shall, except as provided in paragraphs (2), (3), and (4) of this
p.000603: subsection, make the change in accordance with the fol- lowing:
p.000603:
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p.000603: January 30, 2020
p.000603: (A) Not later than 100 days after the report is sub- mitted under subsection (e)(7)(A), the official shall
p.000603: initiate the applicable public process required in subsection (d) to- ward making the change.
p.000603: (B) The change shall be fully implemented not later than the expiration of the 3-year period beginning
p.000603: on the date on which such process is initiated.
...

p.000607: writing to complete the entire period of the assignment or one year of the assignment, whichever is
p.000607: shorter, unless separated or reassigned for reasons which are be- yond the control of the expert or consultant
p.000607: and which are accept- able to the Secretary. If the expert or consultant violates the agree- ment, the money spent
p.000607: by the United States for such expenses is
p.000607: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000609: 609
p.000609: PUBLIC HEALTH SERVICE ACT
p.000609: Sec. 402
p.000609:
p.000609: recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part
p.000609: a right of re- covery under this subparagraph.
p.000609: (e) The Director of NIH shall—
p.000609: (1) advise the agencies of the National Institutes of Health on medical applications of research;
p.000609: (2) coordinate, review, and facilitate the systematic identi- fication and evaluation of, clinically relevant
p.000609: information from research conducted by or through the national research insti- tutes;
p.000609: (3) promote the effective transfer of the information de- scribed in paragraph (2) to the health care
p.000609: community and to entities that require such information;
p.000609: (4) monitor the effectiveness of the activities described in paragraph (3); and
p.000609: (5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed
p.000609: or funded by the National Institutes of Health and intended for the gen- eral public are in a form that does
p.000609: not exceed a level of func- tional literacy, as defined in the National Literacy Act of 1991 (Public Law 102–73)
p.000609: 3.
p.000609: (f) There shall be in the National Institutes of Health an Asso- ciate Director for Prevention. The Director of NIH
p.000609: shall delegate to the Associate Director for Prevention the functions of the Director relating to the
p.000609: promotion of the disease prevention research pro- grams of the national research institutes and the
p.000609: coordination of such programs among the national research institutes and between the national research institutes
p.000609: and other public and private enti- ties, including elementary, secondary, and post-secondary schools. The
p.000609: Associate Director shall—
p.000609: (1) annually review the efficacy of existing policies and techniques used by the national research institutes
p.000609: to dissemi- nate the results of disease prevention and behavioral research programs; and
p.000609: (2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to
p.000609: ensure max- imum dissemination, using advanced technologies to the max- imum extent practicable, of research
p.000609: results to such entities. ø(g) Transferred to section 461, redesignated as subsection (b)
p.000609: of such section, and amended (as so redesignated) by section 221(b)(5) of division F of Public Law
p.000609: 112–74.¿
p.000609: (h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of
...

p.000633: demographic variables, including biological and social variables and rel- evant age categories (such as pediatric
p.000633: subgroups), and de- terminants of health, that contribute to research on minor- ity health and health disparities.
p.000633: (C) Research activities listed in the catalog shall in- clude, where applicable, the following:
p.000633: (i) Epidemiological studies and longitudinal stud-
p.000633:
p.000633:
p.000633: January 30, 2020
p.000633: ies.
p.000633:
p.000633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000635: 635
p.000635: PUBLIC HEALTH SERVICE ACT
p.000635: Sec. 403
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p.000635: January 30, 2020
p.000635: (ii) Disease registries, information clearinghouses, and other data systems.
p.000635: (iii) Public education and information campaigns.
p.000635: (iv) Training activities, including—
p.000635: (I) National Research Service Awards and Clinical Transformation Science Awards;
p.000635: (II) graduate medical education programs, in- cluding information on the number and type of graduate
p.000635: degrees awarded during the period in which the programs received funding under this title;
p.000635: (III) investigator-initiated awards for postdoctoral training and postdoctoral training funded
p.000635: through research grants;
p.000635: (IV) a breakdown by demographic variables and other appropriate categories; and
p.000635: (V) an evaluation and comparison of outcomes and effectiveness of various training programs.
p.000635: (v) Clinical trials, including a breakdown of par- ticipation by study populations and demographic vari- ables,
p.000635: including relevant age categories (such as pedi- atric subgroups), information submitted by each na- tional
p.000635: research institute and national center to the Di- rector of National Institutes of Health under section 492B(f),
p.000635: and such other information as may be nec- essary to demonstrate compliance with section 492B and other
p.000635: applicable requirements regarding inclusion of demographic groups.
p.000635: (vi) Translational research activities with other agencies of the Public Health Service.
p.000635: (5) A summary of the research activities throughout the agencies, which summary shall be organized by
p.000635: the following categories, where applicable:
p.000635: (A) Cancer.
p.000635: (B) Neurosciences.
p.000635: (C) Life stages, human development, and rehabilita- tion.
p.000635: (D) Organ systems.
p.000635: (E) Autoimmune diseases.
p.000635: (F) Genomics.
p.000635: (G) Molecular biology and basic science.
p.000635: (H) Technology development.
p.000635: (I) Chronic diseases, including pain and palliative care.
p.000635: (J) Infectious diseases and bioterrorism.
...

p.000635: SEC. 403A. ø283a¿ ANNUAL REPORTING TO INCREASE INTERAGENCY COLLABORATION AND COORDINATION.
p.000635: (a) COLLABORATION WITH OTHER HHS AGENCIES.—On an an- nual basis, the Director of NIH shall submit to the
p.000635: Secretary a re- port on the activities of the National Institutes of Health involving collaboration with other agencies
p.000635: of the Department of Health and Human Services.
p.000635: (b) CLINICAL TRIALS.—Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a
p.000635: report that identifies each clinical trial that is registered during such calendar year in the databank of
p.000635: information established under section 402(i).
p.000635: (c) HUMAN TISSUE SAMPLES.—On an annual basis, the Director of NIH shall submit to the Congress a report
p.000635: that describes how the National Institutes of Health and its agencies store and track human tissue samples.
p.000635: (d) FIRST REPORT.—The first report under subsections (a), (b), and (c) shall be submitted not later than
p.000635: 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006.
p.000635: SEC. 403B. ø283a–1¿ ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.
p.000635: (a) WHISTLEBLOWER COMPLAINTS.—
p.000635: (1) IN GENERAL.—On an annual basis, the Director of NIH shall submit to the Inspector General of the Department
p.000635: of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on
p.000635: Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the
p.000635: Committee on Appro- priations of the Senate a report summarizing the activities of the National Institutes
p.000635: of Health relating to whistleblower complaints.
p.000635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000635:
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p.000637: PUBLIC HEALTH SERVICE ACT
p.000637: Sec. 403D
p.000637:
p.000637: (2) CONTENTS.—For each whistleblower complaint pending during the year for which a report is submitted under this sub-
p.000637: section, the report shall identify the following:
p.000637: (A) Each agency of the National Institutes of Health involved.
p.000637: (B) The status of the complaint.
p.000637: (C) The resolution of the complaint to date.
p.000637: (b) FIRST REPORT.—The first report under subsection (a) shall be submitted not later than 1 year after the date
p.000637: of the enactment of the National Institutes of Health Reform Act of 2006.
p.000637: SEC. 403C. ø283a–2¿ ANNUAL REPORTING REGARDING TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES.
p.000637: (a) IN GENERAL.—Each institution receiving an award under this title for the training of graduate students for
p.000637: doctoral degrees shall annually report to the Director of NIH, with respect to grad- uate students supported by the
p.000637: National Institutes of Health at such institution—
p.000637: (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
...

p.000641: representatives of all other Federal departments and agencies whose pro- grams involve health functions or
p.000641: responsibilities relevant to such diseases, including the Centers for Disease Control
p.000641: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000641: Sec. 404E PUBLIC HEALTH SERVICE ACT 642
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p.000641: January 30, 2020
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p.000641: and Prevention, the Health Resources and Services Admin- istration, the Food and Drug Administration, and the
p.000641: Ad- ministration for Community Living and representatives of other governmental agencies that serve
p.000641: children and adults with muscular dystrophy, including the Department of Education and the Social Security
p.000641: Administration; and
p.000641: (B) 1⁄3 of such members shall be public members, in- cluding a broad cross section of persons affected with
p.000641: mus- cular dystrophies including parents or legal guardians, af- fected individuals, researchers, and clinicians.
p.000641: Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an
p.000641: unlimited number of terms if reappointed.
p.000641: (3) CHAIR.—
p.000641: (A) IN GENERAL.—With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the
p.000641: principal advisor to the Secretary, the Assistant Sec- retary for Health, and the Director of NIH, and shall
p.000641: pro- vide advice to the Director of the Centers for Disease Con- trol and Prevention, the Commissioner of Food and
p.000641: Drugs, and to the heads of other relevant agencies. The Coordi- nating Committee shall select the Chair
p.000641: for a term not to exceed 2 years.
p.000641: (B) APPOINTMENT.—The Chair of the Committee shall be appointed by and be directly responsible to the
p.000641: Sec- retary.
p.000641: (4) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PROVISIONS.—The following shall apply with respect to the
p.000641: Co- ordinating Committee:
p.000641: (A) The Coordinating Committee shall receive nec- essary and appropriate administrative support from the
p.000641: Department of Health and Human Services.
p.000641: (B) The Coordinating Committee shall meet as appro- priate as determined by the Secretary, in consultation with
p.000641: the chair, but shall meet no fewer than two times per cal- endar year.
p.000641: (e) PLAN FOR HHS ACTIVITIES.—
p.000641: (1) IN GENERAL.—Not later than 1 year after the date of enactment of this section, the Coordinating
p.000641: Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy
p.000641: through the agencies rep- resented on the Coordinating Committee pursuant to sub- section (d)(2)(A)
p.000641: and shall periodically review and revise the plan. The plan shall—
p.000641: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000641: epidemiological, psychosocial, public services, and rehabilitative issues, in- cluding studies of the impact of
p.000641: such diseases in rural and underserved communities, studies to demonstrate the cost- effectiveness of providing
p.000641: independent living resources and support to patients with various forms of muscular dys- trophy, and
p.000641: studies to determine optimal clinical care interventions for adults with various forms of muscular
p.000641: dystrophy;
p.000641: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000643: 643
p.000643: PUBLIC HEALTH SERVICE ACT
p.000643: Sec. 404I
p.000643:
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p.000643: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000643: regarding such diseases; and
p.000643: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000643: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to each form of
p.000643: muscular dys- trophy, provide for the following as appropriate:
p.000643: (A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dys-
p.000643: trophy.
p.000643: (B) Basic research concerning the etiology and genetic links of the disease and potential causes of mutations.
p.000643: (C) The development of improved screening tech- niques.
p.000643: (D) Basic and clinical research for the development and evaluation of new treatments, including new biological
p.000643: agents and new clinical interventions to improve the health of those with muscular dystrophy.
p.000643: (E) Information and education programs for health care professionals and the public.
p.000643: (f) PUBLIC INPUT.—The Secretary shall, under subsection (a)(1), provide for a means through which the public
p.000643: can obtain informa- tion on the existing and planned programs and activities of the De- partment of Health and
p.000643: Human Services with respect to various forms of muscular dystrophy and through which the Secretary can receive
p.000643: comments from the public regarding such programs and ac- tivities.
p.000643: (g) CLINICAL RESEARCH.—The Coordinating Committee may evaluate the potential need to enhance the clinical
p.000643: research infra- structure required to test emerging therapies for the various forms of muscular dystrophy by
p.000643: prioritizing the achievement of the goals related to this topic in the plan under subsection (e)(1).
p.000643: øSection 404F was transferred and redesignated as section 481 by section 221(c)(2)(A)(i) of Public Law 112–74.¿
p.000643: øSection 404G was transferred and redesignated as section 481A by section 221(c)(3) of Public Law 112–74.¿
p.000643: øSection 404H was repealed by section 2042(f)(1) of Public Law 114–255.¿
p.000643: SEC. 404I. ø283k¿ BIOMEDICAL AND BEHAVIORAL RESEARCH FACILI- TIES.
p.000643: (a) MODERNIZATION AND CONSTRUCTION OF FACILITIES.—
p.000643: (1) IN GENERAL.—The Director of NIH, acting through the Office of the Director of NIH or the Director of the
p.000643: National Institute of Allergy and Infectious Diseases, may make grants or contracts to public and nonprofit
p.000643: private entities to expand, remodel, renovate, or alter existing research facilities or con- struct new
p.000643: research facilities, subject to the provisions of this section.
p.000643: (2) CONSTRUCTION AND COST OF CONSTRUCTION.—For pur- poses of this section, the terms ‘‘construction’’ and ‘‘cost
...

p.000657: mechanism. There shall be no limit on the number of terms that a Di- rector may serve.
p.000657: (C) VACANCIES.—If the office of a Director of a na- tional research institute or national center becomes
p.000657: vacant before the end of such Director’s term, the Director ap- pointed to fill the vacancy shall be
p.000657: appointed for a 5-year term starting on the date of such appointment.
p.000657: (D) CURRENT DIRECTORS.—Each Director of a national research institute or national center who is serving on the date of
p.000657: enactment of the 21st Century Cures Act shall be deemed to be appointed for a 5-year term under this
p.000657: sub- section beginning on such date of enactment.
p.000657: (E) RULE OF CONSTRUCTION.—Nothing in this sub- section shall be construed to limit the authority of the
p.000657: Sec- retary or the Director of National Institutes of Health to terminate the appointment of a director
p.000657: referred to in sub- paragraph (A) before the expiration of such director’s 5- year term.
p.000657: (F) NATURE OF APPOINTMENT.—Appointments and re- appointments under this subsection shall be made on the
p.000657: basis of ability and experience as it relates to the mission of the National Institutes of Health and its
p.000657: components, including compliance with any legal requirement that the Secretary or Director of National
p.000657: Institutes of Health de- termines relevant.
p.000657: (3) NONAPPLICATION OF CERTAIN PROVISION.—The restric- tions contained in section 202 of the Departments of
p.000657: Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993
p.000657: (Public Law 102–394; 42
p.000657: U.S.C. 238f note) related to consultants and individual sci- entists appointed for limited periods of time
p.000657: shall not apply to Directors appointed under this subsection.
p.000657: (b)(1) In carrying out the purposes of section 301 with respect to human diseases or disorders or other
p.000657: aspects of human health for which the national research institutes were established, the Secretary, acting
p.000657: through the Director of each national research in- stitute—
p.000657: (A) shall encourage and support research, investigations, experiments, demonstrations, and studies in
p.000657: the health sciences related to—
p.000657: (i) the maintenance of health,
p.000657: (ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,
p.000657: (iii) the rehabilitation of individuals with human dis- eases, disorders, and disabilities, and
p.000657: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000657:
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p.000657: Sec. 405 PUBLIC HEALTH SERVICE ACT 658
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p.000657:
p.000657: (iv) the expansion of knowledge of the processes un- derlying human diseases, disorders, and disabilities,
p.000657: the processes underlying the normal and pathological func- tioning of the body and its organ systems,
p.000657: and the proc- esses underlying the interactions between the human orga- nism and the environment;
p.000657: (B) may, subject to the peer review prescribed under sec- tion 492(b) and any advisory council review
p.000657: under section 406(a)(3)(A)(i), conduct the research, investigations, experi- ments, demonstrations, and
p.000657: studies referred to in subpara- graph (A);
p.000657: (C) shall, as appropriate, conduct and support research that has the potential to transform the
p.000657: scientific field, has in- herently higher risk, and that seeks to address major current challenges;
p.000657: (D) may conduct and support research training (i) for which fellowship support is not provided under
p.000657: section 487, and (ii) which is not residency training of physicians or other health professionals;
p.000657: (E) may develop, implement, and support demonstrations and programs for the application of the results of the
p.000657: activities of the institute to clinical practice and disease prevention ac- tivities;
p.000657: (F) may develop, conduct, and support public and profes- sional education and information programs;
p.000657: (G) may secure, develop and maintain, distribute, and sup- port the development and maintenance of resources needed for
p.000657: research;
p.000657: (H) may make available the facilities of the institute to ap- propriate entities and individuals engaged in
p.000657: research activi- ties and cooperate with and assist Federal and State agencies charged with protecting the
p.000657: public health;
p.000657: (I) may accept unconditional gifts made to the institute for its activities, and, in the case of gifts of a
p.000657: value in excess of
p.000657: $50,000, establish suitable memorials to the donor;
p.000657: (J) may secure for the institute consultation services and advice of persons from the United States or abroad;
p.000657: (K) may use, with their consent, the services, equipment, personnel, information, and facilities of other
p.000657: Federal, State, or local public agencies, with or without reimbursement therefor;
p.000657: (L) may accept voluntary and uncompensated services; and
p.000657: (M) may perform such other functions as the Secretary de- termines are needed to carry out effectively the purposes of
p.000657: the institute.
p.000657: The indemnification provisions of section 2354, title 10, United States Code, shall apply with respect to
p.000657: contracts entered into under this subsection and section 402(b).
p.000657: (2) Support for an activity or program under this subsection may be provided through grants, contracts,
p.000657: and cooperative agree- ments. The Secretary, acting through the Director of each national research institute—
p.000657: (A) may enter into a contract for research, training, or demonstrations only if the contract has been
p.000657: recommended
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p.000665: less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee
p.000665: on Appropriations and the Committee on Labor and Human Resources of the Sen- ate and the Committee on
p.000665: Appropriations and the Committee on Commerce of the House of Representatives a report con- cerning the
p.000665: conference.
p.000665: (c) MORRIS K. UDALL RESEARCH CENTERS.—
p.000665: (1) IN GENERAL.—The Director of NIH is authorized to award Core Center Grants to encourage the development of
p.000665: in- novative multidisciplinary research and provide training con- cerning Parkinson’s disease. The
p.000665: Director is authorized to award not more than 10 Core Center Grants and designate each center funded
p.000665: under such grants as a Morris K. Udall Center for Research on Parkinson’s Disease.
p.000665: (2) REQUIREMENTS.—
p.000665: (A) IN GENERAL.—With respect to Parkinson’s disease, each center assisted under this subsection shall—
p.000665: (i) use the facilities of a single institution or a con- sortium of cooperating institutions, and meet such
p.000665: qualifications as may be prescribed by the Director of the NIH; and
p.000665: (ii) conduct basic and clinical research.
p.000665: (B) DISCRETIONARY REQUIREMENTS.—With respect to Parkinson’s disease, each center assisted under this sub-
p.000665: section may—
p.000665: (i) conduct training programs for scientists and health professionals;
p.000665: (ii) conduct programs to provide information and continuing education to health professionals;
p.000665: (iii) conduct programs for the dissemination of in- formation to the public;
p.000665: (iv) separately or in collaboration with other cen- ters, establish a nationwide data system derived from
p.000665: patient populations with Parkinson’s disease, and where possible, comparing relevant data involving
p.000665: general populations;
p.000665: (v) separately or in collaboration with other cen- ters, establish a Parkinson’s Disease Information
p.000665: Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson’s disease; and
p.000665: (vi) separately or in collaboration with other cen- ters, establish a national education program that
p.000665: fos- ters a national focus on Parkinson’s disease and the care of those with Parkinson’s disease.
p.000665: (3) STIPENDS REGARDING TRAINING PROGRAMS.—A center may use funds provided under paragraph (1) to
p.000665: provide sti- pends for scientists and health professionals enrolled in train- ing programs under paragraph
p.000665: (2)(B).
p.000665: (4) DURATION OF SUPPORT.—Support of a center under this subsection may be for a period not exceeding five
p.000665: years. Such period may be extended by the Director of NIH for one or more additional periods of not more than five
p.000665: years if the operations of such center have been reviewed by an appropriate technical and scientific peer review
p.000665: group established by the Director
p.000665: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000665: Sec. 409C PUBLIC HEALTH SERVICE ACT 666
p.000665:
p.000665: and if such group has recommended to the Director that such period should be extended.
p.000665: (d) MORRIS K. UDALL AWARDS FOR EXCELLENCE IN PARKIN- SON’S DISEASE RESEARCH.—The Director of NIH is
p.000665: authorized to es- tablish a grant program to support investigators with a proven record of excellence and
p.000665: innovation in Parkinson’s disease research and who demonstrate potential for significant future breakthroughs in the
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p.000671: January 30, 2020
p.000671: tional research institutes involved in research with respect to autoimmune diseases and representatives of
p.000671: all other Federal departments and agencies whose programs involve health func- tions or responsibilities relevant to
p.000671: such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.
p.000671: (3) CHAIR.—
p.000671: (A) IN GENERAL.—With respect to autoimmune dis- eases, the Chair of the Committee shall serve as the prin- cipal
p.000671: advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice
p.000671: to the Director of the Centers for Disease Control and Pre- vention, the Commissioner of Food and Drugs, and
p.000671: other relevant agencies.
p.000671: (B) DIRECTOR OF NIH.—The Chair of the Committee shall be directly responsible to the Director of NIH.
p.000671: (c) PLAN FOR NIH ACTIVITIES.—
p.000671: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of this section, the Coordinating
p.000671: Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases
p.000671: through the national research institutes and shall periodically review and revise the plan. The plan shall—
p.000671: (A) provide for a broad range of research and edu- cation activities relating to biomedical,
p.000671: psychosocial, and rehabilitative issues, including studies of the dispropor- tionate impact of such diseases on
p.000671: women;
p.000671: (B) identify priorities among the programs and activi- ties of the National Institutes of Health
p.000671: regarding such diseases; and
p.000671: (C) reflect input from a broad range of scientists, pa- tients, and advocacy groups.
p.000671: (2) CERTAIN ELEMENTS OF PLAN.—The plan under para- graph (1) shall, with respect to autoimmune diseases,
p.000671: provide for the following as appropriate:
p.000671: (A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
p.000671: (B) Basic research concerning the etiology and causes of the diseases.
p.000671: (C) Epidemiological studies to address the frequency and natural history of the diseases, including any
p.000671: dif- ferences among the sexes and among racial and ethnic groups.
p.000671: (D) The development of improved screening tech- niques.
p.000671: (E) Clinical research for the development and evalua- tion of new treatments, including new biological agents.
p.000671: (F) Information and education programs for health care professionals and the public.
p.000671: (3) IMPLEMENTATION OF PLAN.—The Director of NIH shall ensure that programs and activities of the National
p.000671: Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph
p.000671: (1).
p.000671: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000671: Sec. 409F PUBLIC HEALTH SERVICE ACT 672
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p.000671: January 30, 2020
p.000671:
p.000671: MUSCULAR DYSTROPHY RESEARCH
p.000671: SEC. 409F. ø284j¿ (a) COORDINATION OF ACTIVITIES.—The Di-
p.000671: rector of NIH shall expand and increase coordination in the activi- ties of the National Institutes of Health
p.000671: with respect to research on muscular dystrophies, including Duchenne muscular dystrophy.
p.000671: (b) ADMINISTRATION OF PROGRAM; COLLABORATION AMONG AGENCIES.—The Director of NIH shall carry
p.000671: out this section through the appropriate institutes, including the National Institute of Neurological Disorders and
p.000671: Stroke and in collaboration with any other agencies that the Director determines appropriate.
p.000671: SEC. 409G. ø284k¿ CLINICAL RESEARCH.
p.000671: (a) IN GENERAL.—The Director of National Institutes of Health shall undertake activities to support and expand
p.000671: the involvement of the National Institutes of Health in clinical research.
p.000671: (b) REQUIREMENTS.—In carrying out subsection (a), the Direc- tor of National Institutes of Health shall—
p.000671: (1) consider the recommendations of the Division of Re- search Grants Clinical Research Study Group and
p.000671: other rec- ommendations for enhancing clinical research; and
p.000671: (2) establish intramural and extramural clinical research fellowship programs directed specifically at medical
p.000671: and dental students and a continuing education clinical research training program at the National Institutes of
p.000671: Health.
p.000671: (c) SUPPORT FOR THE DIVERSE NEEDS OF CLINICAL RE- SEARCH.—The Director of National Institutes of
p.000671: Health, in coopera- tion with the Directors of the Institutes, Centers, and Divisions of the National
p.000671: Institutes of Health, shall support and expand the re- sources available for the diverse needs of the clinical research
p.000671: com- munity, including inpatient, outpatient, and critical care clinical re- search.
p.000671: (d) PEER REVIEW.—The Director of National Institutes of Health shall establish peer review mechanisms to
p.000671: evaluate applica- tions for the awards and fellowships provided for in subsection (b)(2) and section 409D.
p.000671: Such review mechanisms shall include in- dividuals who are exceptionally qualified to appraise the merits of
p.000671: potential clinical research training and research grant proposals.
p.000671: SEC. 409H. ø284l¿ ENHANCEMENT AWARDS.
p.000671: (a) MENTORED PATIENT-ORIENTED RESEARCH CAREER DEVELOP-
p.000671: MENT AWARDS.—
p.000671: (1) GRANTS.—
p.000671: (A) IN GENERAL.—The Director of the National Insti- tutes of Health shall make grants (to be referred
p.000671: to as ‘‘Mentored Patient-Oriented Research Career Development Awards’’) to support individual careers in clinical
p.000671: research at general clinical research centers or at other institutions that have the infrastructure and resources
p.000671: deemed appro- priate for conducting patient-oriented clinical research.
p.000671: (B) USE.—Grants under subparagraph (A) shall be used to support clinical investigators in the early
p.000671: phases of their independent careers by providing salary and such other support for a period of supervised
p.000671: study.
...

p.000679: (4) are included in appropriate reports to Congress.
p.000679: (7) REVIEW.—The Secretary shall review the necessity of the Committee at least once every 2 years.
p.000679: PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000679: Subpart 1—National Cancer Institute
p.000679: PURPOSE OF INSTITUTE
p.000679: SEC. 410. ø285¿ The general purpose of the National Cancer Institute (hereafter in this subpart referred to as
p.000679: the ‘‘Institute’’) is the conduct and support of research, training, health information dissemination, and
p.000679: other programs with respect to the cause, diag- nosis, prevention, and treatment of cancer, rehabilitation from can-
p.000679: cer, and the continuing care of cancer patients and the families of cancer patients.
p.000679: NATIONAL CANCER PROGRAM
p.000679: SEC. 411. ø285a¿ The National Cancer Program shall consist of (1) an expanded, intensified, and
p.000679: coordinated cancer research program encompassing the research programs conducted and sup- ported by the
p.000679: Institute and the related research programs of the other national research institutes, including an
p.000679: expanded and in- tensified research program for the prevention of cancer caused by occupational or
p.000679: environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.
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p.000679: January 30, 2020
p.000679: CANCER CONTROL PROGRAMS
p.000679: SEC. 412. ø285a–1¿ The Director of the Institute shall estab- lish and support demonstration, education, and
p.000679: other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and
p.000679: counseling respecting cancer. Programs es- tablished and supported under this section shall include—
p.000679: (1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit
p.000679: research results and to disseminate information respecting—
p.000679: (A) the detection, diagnosis, prevention, and treatment of cancer,
p.000679: (B) the continuing care of cancer patients and the fam- ilies of cancer patients, and
p.000679: (C) rehabilitation and counseling respecting cancer,
p.000679: to physicians and other health professionals who provide care to individuals who have cancer;
p.000679: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000681: 681
p.000681: PUBLIC HEALTH SERVICE ACT
p.000681: Sec. 413
p.000681:
p.000681: (2) the demonstration of and the education of students of the health professions and health professionals in—
p.000681: (A) effective methods for the prevention and early de- tection of cancer and the identification of individuals
p.000681: with a high risk of developing cancer, and
p.000681: (B) improved methods of patient referral to appro- priate centers for early diagnosis and treatment of cancer;
p.000681: and
p.000681: (3) the demonstration of new methods for the dissemina- tion of information to the general public concerning
p.000681: the preven- tion, early detection, diagnosis, and treatment and control of cancer and information concerning
p.000681: unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and
p.000681: control of cancer.
p.000681: SPECIAL AUTHORITIES OF THE DIRECTOR
p.000681: SEC. 413. ø285a–2¿ (a)(1) The Director of the Institute shall es- tablish an information and education program to
p.000681: collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate
p.000681: means, to cancer patients and their families, physicians and other health professionals, and the general
p.000681: public, information on cancer research, diagnosis, prevention, and treat- ment (including information respecting
p.000681: nutrition programs for can- cer patients and the relationship between nutrition and cancer). The Director of
p.000681: the Institute may take such action as may be nec- essary to insure that all channels for the dissemination and
p.000681: ex- change of scientific knowledge and information are maintained be- tween the Institute and the public and
p.000681: between the Institute and other scientific, medical, and biomedical disciplines and organiza- tions
p.000681: nationally and internationally.
p.000681: (2) In carrying out paragraph (1), the Director of the Institute shall—
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p.000681: January 30, 2020
p.000681: (A) provide public and patient information and education programs, providing information that will help
p.000681: individuals take personal steps to reduce their risk of cancer, to make them aware of early detection
p.000681: techniques and to motivate appro- priate utilization of those techniques, to help individuals deal with
p.000681: cancer if it strikes, and to provide information to improve long-term survival;
p.000681: (B) continue and expand programs to provide physicians and the public with state-of-the-art information on
p.000681: the treat- ment of particular forms of cancers, and to identify those clin- ical trials that might benefit
p.000681: patients while advancing knowl- edge of cancer treatment;
p.000681: (C) assess the incorporation of state-of-the-art cancer treat- ments into clinical practice and the extent to which
p.000681: cancer pa- tients receive such treatments and include the results of such assessments in the biennial reports
p.000681: required under section 407;
p.000681: (D) maintain and operate the International Cancer Re- search Data Bank, which shall collect, catalog,
p.000681: store, and dis- seminate insofar as feasible the results of cancer research and treatment undertaken in any country
p.000681: for the use of any person involved in cancer research and treatment in any country; and
p.000681: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000681: Sec. 413 PUBLIC HEALTH SERVICE ACT 682
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p.000681: January 30, 2020
p.000681:
p.000681: (E) to the extent practicable, in disseminating the results of such cancer research and treatment, utilize
p.000681: information sys- tems available to the public.
p.000681: (b) The Director of the Institute in carrying out the National Cancer Program—
p.000681: (1) shall establish or support the large-scale production or distribution of specialized biological materials and other
p.000681: thera- peutic substances for cancer research and set standards of safety and care for persons using such
p.000681: materials;
p.000681: (2) shall, in consultation with the advisory council for the Institute, support (A) research in the
p.000681: cancer field outside the United States by highly qualified foreign nationals which can be expected to
p.000681: benefit the American people, (B) collaborative research involving American and foreign participants, and
p.000681: (C) the training of American scientists abroad and foreign sci- entists in the United States;
p.000681: (3) shall, in consultation with the advisory council for the Institute, support appropriate programs of
p.000681: education and train- ing (including continuing education and laboratory and clinical research training);
p.000681: (4) shall encourage and coordinate cancer research by in- dustrial concerns where such concerns evidence
p.000681: a particular capability for such research;
p.000681: (5) may obtain (after consultation with the advisory council for the Institute and in accordance with section
p.000681: 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of
p.000681: service) the services of not more than one hundred and fifty-one experts or consultants who have
p.000681: scientific or professional qualifications;
p.000681: (6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve,
p.000681: repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal
p.000681: property as the Director determines necessary;
p.000681: (B) may, in consultation with the advisory council for the Institute, make grants for construction or
p.000681: renovation of facili- ties; and
p.000681: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000681: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Adminis- trator of General Services,
p.000681: buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of
p.000681: Columbia for the use of the Institute for a period not to exceed ten years;
p.000681: (7) may, in consultation with the advisory council for the Institute, appoint one or more advisory
p.000681: committees composed of such private citizens and officials of Federal, State, and local governments to advise the
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p.000683: January 30, 2020
p.000683:
p.000683: NATIONAL CANCER RESEARCH AND DEMONSTRATION CENTERS
p.000683:
p.000683: SEC. 414. ø285a–3¿ (a)(1) The Director of the Institute may enter into cooperative agreements with and
p.000683: make grants to public or private nonprofit entities to pay all or part of the cost of plan- ning,
p.000683: establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into,
p.000683: training in, and demonstration of advanced diagnostic, prevention, control, and treatment methods for cancer.
p.000683: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000683: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000683: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000683:
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p.000683: Sec. 415 PUBLIC HEALTH SERVICE ACT 684
p.000683:
p.000683: (b) Federal payments made under a cooperative agreement or grant under subsection (a) may be used for—
p.000683: (1) construction (notwithstanding any limitation under sec- tion 496);
p.000683: (2) staffing and other basic operating costs, including such patient care costs as are required for research;
p.000683: (3) clinical training, including training for allied health professionals, continuing education for health
p.000683: professionals and allied health professions personnel, and information programs for the public respecting cancer;
p.000683: and
p.000683: (4) demonstration purposes.
p.000683: As used in this paragraph, the term ‘‘construction’’ does not include the acquisition of land, and the term
p.000683: ‘‘training’’ does not include re- search training for which National Research Service Awards 15 may be provided under
p.000683: section 487.
p.000683: (c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be
p.000683: extended by the Di- rector for additional periods of not more than five years each if the operations of such center
p.000683: have been reviewed by an appropriate technical and scientific peer review group established by the Direc- tor and
p.000683: if such group has recommended to the Director that such period should be extended.
p.000683: (d) Research centers under this section may not be considered centers of excellence for purposes of section
p.000683: 402(b)(10).
p.000683: PRESIDENT’S CANCER PANEL
p.000683: SEC. 415. ø285a–4¿ (a)(1) The President’s Cancer Panel (here- after in this section referred to as the
p.000683: ‘‘Panel’’) shall be composed of three persons appointed by the President who by virtue of their training,
p.000683: experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two
p.000683: members of the Panel shall be distinguished scientists or physicians.
p.000683: (2)(A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to
p.000683: fill a vacancy occur- ring prior to the expiration of the term for which the member’s predecessor was
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p.000685: respon- sibilities that are related to breast cancer and other cancers of the reproductive system of women.
p.000685: (c) PROGRAMS FOR BREAST CANCER.—
p.000685: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000685: expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection
p.000685: shall provide for an expansion and intensification of the conduct and support of—
p.000685: (A) basic research concerning the etiology and causes of breast cancer;
p.000685: (B) clinical research and related activities concerning the causes, prevention, detection and treatment of
p.000685: breast cancer;
p.000685: (C) control programs with respect to breast cancer in accordance with section 412, including
p.000685: community-based programs designed to assist women who are members of
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000685:
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p.000685: Sec. 417 PUBLIC HEALTH SERVICE ACT 686
p.000685:
p.000685: medically underserved populations, low-income popu- lations, or minority groups;
p.000685: (D) information and education programs with respect to breast cancer in accordance with section 413; and
p.000685: (E) research and demonstration centers with respect to breast cancer in accordance with section 414, including the
p.000685: development and operation of centers for breast cancer re- search to bring together basic and clinical, biomedical and
p.000685: behavioral scientists to conduct basic, clinical, epidemiolog- ical, psychosocial, prevention and treatment
p.000685: research and related activities on breast cancer.
p.000685: Not less than six centers shall be operated under subpara- graph (E). Activities of such centers should
p.000685: include supporting new and innovative research and training programs for new re- searchers. Such centers shall give
p.000685: priority to expediting the transfer of research advances to clinical applications.
p.000685: (2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—
p.000685: (A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are imple-
p.000685: mented in accordance with a plan for the programs. Such plan shall include comments and recommendations
p.000685: that the Director of the Institute considers appropriate, with due consideration provided to the
p.000685: professional judgment needs of the Institute as expressed in the annual budget estimate prepared in
p.000685: accordance with section 413(9) 16. The Director of the Institute, in consultation with the National Cancer Advisory
p.000685: Board, shall periodically review and re- vise such plan.
p.000685: (B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President’s
p.000685: Cancer Panel, the Secretary and the Director of NIH.
p.000685: (C) The Director of the Institute shall submit any revi- sions of the plan to the President’s Cancer Panel, the Sec-
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p.000685: and the Committee on Labor and Human Resources of the Sen- ate.
p.000685: (d) OTHER CANCERS.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support
p.000685: research on ovarian cancer and other cancers of the reproductive system of women. Ac- tivities under such
p.000685: subsection shall provide for the conduct and support of—
p.000685: (1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive
p.000685: system of women;
p.000685: (2) clinical research and related activities into the causes, prevention, detection and treatment of
p.000685: ovarian cancer and other cancers of the reproductive system of women;
p.000685:
p.000685:
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p.000685: January 30, 2020
p.000685: 16 So in law. See section 401 of Public Law 103–43 (107 Stat. 153). Probably should be section ‘‘413(b)(9)’’.
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000687: PUBLIC HEALTH SERVICE ACT
p.000687: Sec. 417A
p.000687:
p.000687: (3) control programs with respect to ovarian cancer and other cancers of the reproductive system of
p.000687: women in accord- ance with section 412;
p.000687: (4) information and education programs with respect to ovarian cancer and other cancers of the reproductive
p.000687: system of women in accordance with section 413; and
p.000687: (5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive
p.000687: system in ac- cordance with section 414.
p.000687: (e) REPORT.—The Director of the Institute shall prepare, for in- clusion in the biennial report submitted under section
p.000687: 407, a report that describes the activities of the National Cancer Institute under the research programs referred
p.000687: to in subsection (a), that shall in- clude—
p.000687: (1) a description of the research plan with respect to breast
p.000687: cancer prepared under subsection (c);
p.000687: (2) an assessment of the development, revision, and imple- mentation of such plan;
p.000687: (3) a description and evaluation of the progress made, dur- ing the period for which such report is prepared,
p.000687: in the re- search programs on breast cancer and cancers of the reproduc- tive system of women;
p.000687: (4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with
p.000687: re- spect to breast cancer and cancers of the reproductive system of women conducted and supported by
p.000687: the National Institutes of Health; and
p.000687: (5) such comments and recommendations as the Director considers appropriate.
p.000687: PROSTATE CANCER
p.000687: SEC. 417A. ø285a–7¿ (a) EXPANSION AND COORDINATION OF AC-
p.000687: TIVITIES.—The Director of the Institute, in consultation with the National Cancer Advisory Board, shall
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p.000687: (c) PROGRAMS.—
p.000687: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000687: expand the understanding of the cause of, and to find a cure for, pros- tate cancer. Activities under such
p.000687: subsection shall provide for an expansion and intensification of the conduct and support of—
p.000687:
p.000687:
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p.000687: January 30, 2020
p.000687: (A) basic research concerning the etiology and causes of prostate cancer;
p.000687: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000687: Sec. 417A PUBLIC HEALTH SERVICE ACT 688
p.000687:
p.000687: (B) clinical research and related activities concerning the causes, prevention, detection and treatment of
p.000687: prostate cancer;
p.000687: (C) prevention and control and early detection pro- grams with respect to prostate cancer in accordance
p.000687: with section 412, particularly as it relates to intensifying re- search on the role of prostate specific
p.000687: antigen for the screening and early detection of prostate cancer;
p.000687: (D) an Inter-Institute Task Force, under the direction of the Director of the Institute, to provide coordination
p.000687: be- tween relevant National Institutes of Health components of research efforts on prostate cancer;
p.000687: (E) control programs with respect to prostate cancer in accordance with section 412;
p.000687: (F) information and education programs with respect to prostate cancer in accordance with section 413; and
p.000687: (G) research and demonstration centers with respect to prostate cancer in accordance with section 414,
p.000687: includ- ing the development and operation of centers for prostate cancer research to bring together basic
p.000687: and clinical, bio- medical and behavioral scientists to conduct basic, clinical, epidemiological, psychosocial,
p.000687: prevention and control, treatment, research, and related activities on prostate can- cer.
p.000687: Not less than six centers shall be operated under subpara- graph (G). Activities of such centers should
p.000687: include supporting new and innovative research and training programs for new re- searchers. Such centers shall give
p.000687: priority to expediting the transfer of research advances to clinical applications.
p.000687: (2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—
p.000687: (A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are imple-
p.000687: mented in accordance with a plan for the programs. Such plan shall include comments and recommendations
p.000687: that the Director of the Institute considers appropriate, with due consideration provided to the
p.000687: professional judgment needs of the Institute as expressed in the annual budget estimate prepared in
p.000687: accordance with section 413(9) 17. The Director of the Institute, in consultation with the National Cancer Advisory
p.000687: Board, shall periodically review and re- vise such plan.
p.000687: (B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President’s
p.000687: Cancer Panel, the Secretary, and the Director of NIH.
p.000687: (C) The Director of the Institute shall submit any revi- sions of the plan to the President’s Cancer Panel, the Sec-
p.000687: retary, and the Director of NIH.
p.000687: (D) The Secretary shall provide a copy of the plan sub- mitted under subparagraph (A), and any revisions sub-
p.000687: mitted under subparagraph (C), to the Committee on En- ergy and Commerce of the House of Representatives
p.000687: and
p.000687:
p.000687:
p.000687:
p.000687:
p.000687: January 30, 2020
p.000687: 17 So in law. See section 402 of Public Law 103–43 (107 Stat. 155). Probably should be ‘‘section 413(b)(9)’’.
p.000687: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000689: PUBLIC HEALTH SERVICE ACT
p.000689: Sec. 417D
p.000689:
p.000689: the Committee on Labor and Human Resources of the Sen- ate. 18
p.000689: SEC. 417C. ø285a–9¿ GRANTS FOR EDUCATION, PREVENTION, AND EARLY DETECTION OF RADIOGENIC CANCERS AND
p.000689: DIS- EASES.
p.000689: (a) DEFINITION.—In this section the term ‘‘entity’’ means any—
p.000689: (1) National Cancer Institute-designated cancer center;
p.000689: (2) Department of Veterans Affairs hospital or medical center;
p.000689: (3) Federally Qualified Health Center, community health center, or hospital;
p.000689: (4) agency of any State or local government, including any State department of health; or
p.000689: (5) nonprofit organization.
p.000689: (b) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000689: Administration in con- sultation with the Director of the National Institutes of Health and the Director of the
p.000689: Indian Health Service, may make competitive grants to any entity for the purpose of carrying out programs to—
p.000689: (1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure
p.000689: Compensation Act (42
p.000689: U.S.C. 2210 note) for cancer as a preventative health measure;
p.000689: (2) provide appropriate referrals for medical treatment of individuals screened under paragraph (1) and to
p.000689: ensure, to the extent practicable, the provision of appropriate follow-up serv- ices;
p.000689: (3) develop and disseminate public information and edu- cation programs for the detection, prevention, and
p.000689: treatment of radiogenic cancers and diseases; and
p.000689: (4) facilitate putative applicants in the documentation of claims as described in section 5(a) of the
p.000689: Radiation Exposure Compensation Act (42 U.S.C. 2210 note).
p.000689: (c) INDIAN HEALTH SERVICE.—The programs under subsection
p.000689: (a) shall include programs provided through the Indian Health Service or through tribal contracts, compacts,
p.000689: grants, or cooperative agreements with the Indian Health Service and which are deter- mined appropriate to
p.000689: raising the health status of Indians.
p.000689: (d) GRANT AND CONTRACT AUTHORITY.—Entities receiving a grant under subsection (b) may expend the grant
p.000689: to carry out the purpose described in such subsection.
p.000689: (e) HEALTH COVERAGE UNAFFECTED.—Nothing in this section shall be construed to affect any coverage
p.000689: obligation of a govern- mental or private health plan or program relating to an individual referred to under
p.000689: subsection (b)(1).
p.000689: SEC. 417D. ø285a–10¿ RESEARCH, INFORMATION, AND EDUCATION WITH RESPECT TO BLOOD CANCER.
p.000689: (a) JOE MOAKLEY RESEARCH EXCELLENCE PROGRAM.—
p.000689: (1) IN GENERAL.—The Director of NIH shall expand, inten- sify, and coordinate programs for the conduct and
p.000689: support of research with respect to blood cancer, and particularly with re- spect to leukemia, lymphoma, and multiple
p.000689: myeloma.
p.000689:
p.000689:
p.000689:
p.000689: January 30, 2020
p.000689: 18 Section 417B was repealed by section 103(b)(15) of Public Law 109–482 (120 Stat. 3687).
p.000689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000689: Sec. 417E PUBLIC HEALTH SERVICE ACT 690
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p.000689: January 30, 2020
p.000689:
p.000689: (2) ADMINISTRATION.—The Director of NIH shall carry out this subsection through the Director of the National Cancer In-
p.000689: stitute and in collaboration with any other agencies that the Director determines to be appropriate.
p.000689: (b) GERALDINE FERRARO CANCER EDUCATION PROGRAM.—
p.000689: (1) IN GENERAL.—The Secretary shall direct the appro- priate agency within the Department of Health and
p.000689: Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information
p.000689: and education for patients and the general public with respect to blood can- cer, and particularly with
p.000689: respect to the treatment of leukemia, lymphoma, and multiple myeloma.
p.000689: (2) ADMINISTRATION.—The Agency determined by the Sec- retary under paragraph (1) shall carry out this
p.000689: subsection in collaboration with private health organizations that have na- tional education and patient
p.000689: assistance programs on blood-re- lated cancers.
p.000689: SEC. 417E. ø285a–11¿ PEDIATRIC CANCER RESEARCH, AWARENESS, AND SURVIVORSHIP.
p.000689: (a) CHILDREN’S CANCER BIOREPOSITORIES.—
p.000689: (1) AWARD.—The Secretary, acting through the Director of NIH, may make awards to an entity or entities
p.000689: described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and
p.000689: demographic information of chil- dren, adolescents, and young adults with selected cancer subtypes (and
p.000689: their recurrences) for which current treatments are least effective, in order to achieve a better
p.000689: understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of
p.000689: treatments for such cancers.
p.000689: (2) USE OF FUNDS.—Amounts received under an award under paragraph (1) may be used to carry out the following:
p.000689: (A) Collect and store high-quality, donated biospeci- mens and associated clinical and demographic information on
p.000689: children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children,
p.000689: adoles- cents, and young adults with cancer enrolled in clinical trials for whom current treatments are
p.000689: least effective. Ac- tivities under this subparagraph may include storage of biospecimens and associated
p.000689: clinical and demographic data at existing biorepositories supported by the National Can- cer Institute.
p.000689: (B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated
...

p.000693: served populations.
p.000693: (C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on
p.000693: treatment outcomes and survivorship.
p.000693: (D) The development of indicators used for long-term follow-up and analysis of the late effects of
p.000693: cancer treat- ment for pediatric cancer survivors.
p.000693: (E) The identification of, as applicable—
p.000693: (i) risk factors associated with the late effects of cancer treatment;
p.000693: (ii) predictors of adverse neurocognitive and psy- chosocial outcomes; and
p.000693: (iii) the molecular basis of long-term complica- tions.
p.000693: (F) The development of targeted interventions to re- duce the burden of morbidity borne by cancer survivors in
p.000693: order to protect such cancer survivors from the late effects of cancer.
p.000693: (2) BALANCED APPROACH.—In conducting or supporting re- search under paragraph (1)(A)(i) on pediatric cancer
p.000693: survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such
p.000693: research addresses both the physical and the psychological needs of such sur- vivors, as appropriate.
p.000693: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as being inconsistent with the goals and
p.000693: purposes of the Minority Health and Health Disparities Research and Education Act of 2000.
p.000693: (d) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section and section 399E–1, there
p.000693: are authorized to be appropriated $30,000,000 for each of fiscal years 2019 through 2023. Funds
p.000693: appropriated under this subsection shall remain avail- able until expended.
p.000693: SEC. 417F. ø42 U.S.C. 285a–12¿ INTERAGENCY BREAST CANCER AND EN- VIRONMENTAL RESEARCH COORDINATING COMMITTEE.
p.000693: (a) INTERAGENCY BREAST CANCER AND ENVIRONMENTAL RE-
p.000693: SEARCH COORDINATING COMMITTEE.—
p.000693: (1) ESTABLISHMENT.—Not later than 6 months after the date of the enactment of this section, the Secretary shall
p.000693: estab- lish a committee, to be known as the Interagency Breast Can- cer and Environmental Research Coordinating
p.000693: Committee (in this section referred to as the ‘‘Committee’’).
p.000693: (2) DUTIES.—The Committee shall—
p.000693: (A) share and coordinate information on existing re- search activities, and make recommendations to the
p.000693: Na- tional Institutes of Health and other Federal agencies re- garding how to improve existing research
p.000693: programs, that are related to breast cancer research;
p.000693: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000693:
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p.000693: Sec. 417F PUBLIC HEALTH SERVICE ACT 694
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p.000697: January 30, 2020
p.000697: (ii) COORDINATED RESEARCH INITIATIVES.—Pro- moting and developing initiatives and partnerships de- scribed
p.000697: in subparagraph (A)(iv).
p.000697: (iii) RESEARCH RESOURCES.—Developing additional public and private resources described in subpara- graph
p.000697: (A)(v) and strengthening existing resources.
p.000697: (3) TIMING.—
p.000697: (A) INITIAL DEVELOPMENT AND SUBSEQUENT UPDATE.— For each recalcitrant cancer identified under subsection
p.000697: (b)(1), the Director of the Institute shall—
p.000697: (i) develop a scientific framework under this sub- section not later than 18 months after the date of the
p.000697: enactment of this section; and
p.000697: (ii) review and update the scientific framework not later than 5 years after its initial development.
p.000697: (B) OTHER UPDATES.—The Director of the Institute may review and update each scientific framework devel-
p.000697: oped under this subsection as necessary.
p.000697: (4) PUBLIC NOTICE.—With respect to each scientific frame- work developed under subsection (a), not later than
p.000697: 30 days after the date of completion of the framework, the Director of the Institute shall—
p.000697: (A) submit such framework to the Committee on En- ergy and Commerce and Committee on Appropriations of
p.000697: the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and Committee
p.000697: on Appropriations of the Senate; and
p.000697: (B) make such framework publically available on the Internet website of the Department of Health and Human
p.000697: Services.
p.000697: (b) IDENTIFICATION OF RECALCITRANT CANCER.—
p.000697: (1) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Director
p.000697: of the Institute shall identify two or more recalcitrant cancers that each—
p.000697: (A) have a 5-year relative survival rate of less than 20 percent; and
p.000697: (B) are estimated to cause the death of at least 30,000 individuals in the United States per year.
p.000697: (2) ADDITIONAL CANCERS.—The Director of the Institute may, at any time, identify other recalcitrant
p.000697: cancers for pur- poses of this section. In identifying a recalcitrant cancer pursu- ant to the previous sentence,
p.000697: the Director may consider addi- tional metrics of progress (such as incidence and mortality rates) against
p.000697: such type of cancer.
p.000697: (c) WORKING GROUPS.—For each recalcitrant cancer identified under subsection (b), the Director of the
p.000697: Institute shall convene a working group comprised of representatives of appropriate Federal agencies and other
p.000697: non-Federal entities to provide expertise on, and assist in developing, a scientific framework under
p.000697: subsection (a). The Director of the Institute (or the Director’s designee) shall participate in the meetings
p.000697: of each such working group.
p.000697: (d) REPORTING.—
p.000697: (1) BIENNIAL REPORTS.—The Director of NIH shall ensure that each biennial report under section 403
p.000697: includes informa-
p.000697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000697: population-based programs carried out in co- operation with other Federal agencies, with public health agencies of
p.000697: State or local governments, with nonprofit private entities that are community-based health agencies, or
p.000697: with other appropriate public or nonprofit private entities.
p.000697: (b) In carrying out programs under subsection (a), the Director of the Institute shall give special consideration
p.000697: to the prevention and control of heart, blood vessel, lung, and blood diseases in chil- dren, and in populations
p.000697: that are at increased risk with respect to such diseases.
p.000697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000699: PUBLIC HEALTH SERVICE ACT
p.000699: Sec. 421
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p.000699: January 30, 2020
p.000699: INFORMATION AND EDUCATION
p.000699: SEC. 420. ø285b–2¿ The Director of the Institute shall collect, identify, analyze, and disseminate on a timely
p.000699: basis, through publi- cations and other appropriate means, to patients, families of pa- tients, physicians
p.000699: and other health professionals, and the general public, information on research, prevention, diagnosis, and
p.000699: treat- ment of heart, blood vessel, lung, and blood diseases, the mainte- nance of health to reduce the
p.000699: incidence of such diseases, and on the use of blood and blood products and the management of blood re-
p.000699: sources. In carrying out this section, the Director of the Institute shall place special emphasis upon the
p.000699: utilization of collaborative ef- forts with both the public and private sectors to—
p.000699: (1) increase the awareness and knowledge of health care professionals and the public regarding the
p.000699: prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and
p.000699: (2) develop and disseminate to health professionals, pa- tients and patient families, and the public
p.000699: information de- signed to encourage adults and children to adopt healthful practices concerning the prevention
p.000699: of such diseases.
p.000699: NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD RESOURCES PROGRAM
p.000699: SEC. 421. ø285b–3¿ (a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources
p.000699: Program (hereafter in this subpart referred to as the ‘‘Program’’ may provide for—
p.000699: (A) investigation into the epidemiology, etiology, and pre- vention of all forms and aspects of heart,
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p.000699: diseases;
p.000699: (D) establishment of programs that will focus and apply scientific and technological efforts involving
p.000699: the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood
p.000699: diseases with emphasis on the refine- ment, development, and evaluation of technological devices that will
p.000699: assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of
p.000699: and rehabilitation from such diseases;
p.000699: (E) establishment of programs for the conduct and direc- tion of field studies, large-scale testing and
p.000699: evaluation, and demonstration of preventive, diagnostic, therapeutic, and reha-
p.000699: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000699: Sec. 421 PUBLIC HEALTH SERVICE ACT 700
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p.000699: bilitative approaches to, and emergency medical services for, such diseases;
p.000699: (F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects
p.000699: of the management of blood resources in the United States, including the collection, preservation, fractionation,
p.000699: and distribution of blood and blood products;
p.000699: (G) the education (including continuing education) and training of scientists, clinical investigators, and
p.000699: educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs
p.000699: respecting heart, blood vessel, lung, and blood diseases and blood resources;
p.000699: (H) public and professional education relating to all as- pects of such diseases, including the
p.000699: prevention of such dis- eases, and the use of blood and blood products and the man- agement of blood
p.000699: resources;
p.000699: (I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of
p.000699: children (includ- ing cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and
p.000699: Cooley’s anemia, and hemophilic dis- eases) and for the development and demonstration of diag- nostic,
p.000699: treatment, and preventive approaches to such diseases; and
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p.000699: (J) establishment of programs for study, research, develop- ment, demonstrations and evaluation of emergency
p.000699: medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.
p.000699: (2) The Program shall be coordinated with other national re- search institutes to the extent that they
p.000699: have responsibilities re- specting such diseases and shall give special emphasis to the con- tinued
p.000699: development in the Institute of programs related to the causes of stroke and to effective coordination of such
...

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p.000701: January 30, 2020
p.000701: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000701: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Adminis- trator of General
p.000701: Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the
p.000701: District of Columbia for the use of the Institute for a period not to exceed ten years;
p.000701: (3) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
p.000701: and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such con- tracts, leases,
p.000701: cooperative agreements, or other transactions, as may be necessary in the conduct of the Director’s functions,
p.000701: with any public agency, or with any person, firm, association, corporation, or educational institutions;
p.000701: (4) may make grants to public and nonprofit private enti- ties to assist in meeting the cost of the care of
p.000701: patients in hos- pitals, clinics, and related facilities who are participating in re- search projects; and
p.000701: (5) shall, in consultation with the advisory council for the Institute, conduct appropriate intramural
p.000701: training and edu- cation programs, including continuing education and laboratory and clinical research training
p.000701: programs.
p.000701: Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (1) shall be paid
p.000701: or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place
p.000701: of service and for other expenses associated with their assignment. Such expenses shall not be allowed
p.000701: in con- nection with the assignment of an expert or consultant whose serv- ices are obtained under paragraph (1)
p.000701: unless the expert or consult- ant has agreed in writing to complete the entire period of the as- signment
p.000701: or one year of the assignment, whichever is shorter, un- less separated or reassigned for reasons which are
p.000701: beyond the con- trol of the expert or consultant and which are acceptable to the Di- rector of the Institute. If
p.000701: the expert or consultant violates the agreement, the money spent by the United States for such ex-
p.000701: penses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive
p.000701: in whole or in part a right of recovery under the preceding sentence.
p.000701: NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES, SICKLE
p.000701: CELL ANEMIA, AND BLOOD RESOURCES
p.000701: SEC. 422. ø285b–4¿ (a)(1) The Director of the Institute may provide, in accordance with subsection (c), for
p.000701: the development of—
p.000701: (A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services)
...

p.000701: research into blood, in the use of blood products and in the management of blood re- sources; and
p.000701: (D) three centers for basic and clinical research into, train- ing in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment (including genetic studies, intrauterine environ- ment studies, postnatal studies, heart
p.000701: arrhythmias, and ac- quired heart disease and preventive cardiology) for cardio- vascular diseases in
p.000701: children.
p.000701: (2) The centers developed under paragraph (1) shall, in addi- tion to being utilized for research, training,
p.000701: and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood
p.000701: diseases:
p.000701: (A) Programs to develop improved methods of detecting in- dividuals with a high risk of developing
p.000701: cardiovascular, pul- monary, and blood diseases.
p.000701: (B) Programs to develop improved methods of intervention against those factors which cause individuals to have
p.000701: a high risk of developing such diseases.
p.000701: (C) Programs to develop health professions and allied health professions personnel highly skilled in the
p.000701: prevention of such diseases.
p.000701: (D) Programs to develop improved methods of providing emergency medical services for persons with such diseases.
p.000701: (E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and
p.000701: treat- ment of such diseases and the maintenance of health to reduce the incidence of such diseases and
p.000701: information programs for the public respecting the prevention and early diagnosis and treatment of such
p.000701: diseases and the maintenance of health.
p.000701: (3) The research, training, and demonstration activities carried out through any such center may relate to any one or
p.000701: more of the diseases referred to in paragraph (1) of this subsection.
p.000701: (b) The Director of the Institute shall provide, in accordance with subsection (c), for the development of ten
p.000701: centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia.
p.000701: (c)(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or
p.000701: private nonprofit en- tities to pay all or part of the cost of planning, establishing, or strengthening,
p.000701: and providing basic operating support for centers for basic and clinical research into, training in, and
p.000701: demonstration of the management of blood resources and advanced diagnostic, pre- vention, and treatment
p.000701: methods for heart, blood vessel, lung, or blood diseases.
p.000701: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000701: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000701: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000703: (d)’’.
p.000703: 21 So in law. See section 503 of Public Law 103–43 (107 Stat. 159). Probably should be capital- ized.
p.000703: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000705: 705
p.000705: PUBLIC HEALTH SERVICE ACT
p.000705: Sec. 424A
p.000705:
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p.000705: January 30, 2020
p.000705: (3) The Director of the National Institutes of Health (after con- sultation with the Director of the Center and the
p.000705: advisory board es- tablished under subsection (c)) shall revise the plan developed under paragraph (1) as
p.000705: appropriate.
p.000705: (e) The Director of the Center, in cooperation with the Centers for Disease Control and Prevention, is authorized to
p.000705: coordinate ac- tivities with the Department of Transportation, the Department of Defense, the Department of
p.000705: Education, the Department of Labor, and the Department of Commerce to collect data, conduct studies, and
p.000705: disseminate public information concerning the impact of sleep disorders and sleep deprivation.
p.000705: HEART ATTACK, STROKE, AND OTHER CARDIOVASCULAR DISEASES IN WOMEN
p.000705: SEC. 424A. ø285b–7a¿ (a) IN GENERAL.—The Director of the Institute shall expand, intensify, and coordinate
p.000705: research and re- lated activities of the Institute with respect to heart attack, stroke, and other cardiovascular
p.000705: diseases in women.
p.000705: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate activities under
p.000705: subsection (a) with similar activities conducted by the other national research insti- tutes and agencies
p.000705: of the National Institutes of Health to the ex- tent that such Institutes and agencies have
p.000705: responsibilities that are related to heart attack, stroke, and other cardiovascular dis- eases in women.
p.000705: (c) CERTAIN PROGRAMS.—In carrying out subsection (a), the Di- rector of the Institute shall conduct or support research
p.000705: to expand the understanding of the causes of, and to develop methods for pre- venting, cardiovascular diseases in
p.000705: women. Activities under such subsection shall include conducting and supporting the following:
p.000705: (1) Research to determine the reasons underlying the prev- alence of heart attack, stroke, and other
p.000705: cardiovascular dis- eases in women, including African-American women and other women who are members of racial
p.000705: or ethnic minority groups.
p.000705: (2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
p.000705: (3) Epidemiological studies to address the frequency and natural history of such diseases and the
p.000705: differences among men and women, and among racial and ethnic groups, with re- spect to such diseases.
p.000705: (4) The development of safe, efficient, and cost-effective di- agnostic approaches to evaluating women with
p.000705: suspected ischemic heart disease.
p.000705: (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
p.000705: (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women,
p.000705: including appli- cations of effective methods for the control of blood pressure, lipids, and obesity.
p.000705: (7) Information and education programs for patients and health care providers on risk factors associated
p.000705: with heart at- tack, stroke, and other cardiovascular diseases in women, and on the importance of the
p.000705: prevention or control of such risk fac-
p.000705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000705:
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p.000705: Sec. 424B PUBLIC HEALTH SERVICE ACT 706
p.000705:
p.000705: tors and timely referral with appropriate diagnosis and treat- ment. Such programs shall include
p.000705: information and education on health-related behaviors that can improve such important risk factors as
p.000705: smoking, obesity, high blood cholesterol, and lack of exercise.
p.000705: COORDINATION OF FEDERAL ASTHMA ACTIVITIES
p.000705: SEC. 424B 22 ø285b–7b¿ (a) IN GENERAL.—The Director of In- stitute shall, through the National Asthma
p.000705: Education Prevention Program Coordinating Committee—
p.000705: (1) identify all Federal programs that carry out asthma-re- lated activities; and
p.000705: (2) develop, in consultation with appropriate Federal agen- cies and professional and voluntary health
p.000705: organizations, a Federal plan for responding to asthma.
p.000705: (b) REPRESENTATION OF THE DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT.—A representative of the
p.000705: Department of Housing and Urban Development shall be included on the National Asthma Education Prevention Program
p.000705: Coordinating Committee for the purpose of performing the tasks described in subsection (a). 23
p.000705: SEC. 424C. ø285b–7c¿ TUBERCULOSIS.
p.000705: (a) IN GENERAL.—The Director of the National Institutes of Health may expand, intensify, and coordinate
p.000705: research and devel- opment and related activities of the Institutes with respect to tu- berculosis
p.000705: including activities toward the goal of eliminating such disease.
p.000705: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000705: (1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis;
p.000705: (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and
p.000705: (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods
p.000705: to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.
p.000705: SEC. 425. ø285b–8¿ CONGENITAL HEART DISEASE.
p.000705: (a) IN GENERAL.—The Director of the Institute may expand, in- tensify, and coordinate research and related activities
p.000705: of the Insti- tute with respect to congenital heart disease, which may include congenital heart disease
p.000705: research with respect to—
p.000705: (1) causation of congenital heart disease, including genetic causes;
p.000705: (2) long-term outcomes in individuals with congenital heart disease, including infants, children,
p.000705: teenagers, adults, and elderly individuals;
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p.000713: under this section may be for a period of not to exceed five years and such period may be extended
p.000713: by the Director of the Institute for additional periods of not more than five years each if the operations of
p.000713: such center have been reviewed by an appropriate technical and scientific peer review group estab- lished
p.000713: by the Director and if such group has recommended to the Director that such period should be extended.
p.000713:
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p.000713: January 30, 2020
p.000713:
p.000713: ADVISORY COUNCIL SUBCOMMITTEES
p.000713: SEC. 432. ø285c–6¿ There are established within the advisory council for the Institute appointed under
p.000713: section 406 a sub- committee on diabetes and endocrine and metabolic diseases, a subcommittee on
p.000713: digestive diseases and nutrition, and a sub- committee on kidney, urologic, and hematologic diseases.
p.000713: The sub-
p.000713: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000713:
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p.000713: Sec. 433 PUBLIC HEALTH SERVICE ACT 714
p.000713:
p.000713: committees shall be composed of members of the advisory council who are outstanding in the diagnosis,
p.000713: prevention, and treatment of the diseases for which the subcommittees are established and members of the
p.000713: advisory council who are leaders in the fields of education and public affairs. The subcommittees are
p.000713: authorized to review applications made to the Director of the Institute for grants for research and training projects
p.000713: relating to the diagnosis, preven- tion, and treatment of the diseases for which the subcommittees are
p.000713: established and shall recommend to the advisory council those applications and contracts that the subcommittees
p.000713: determine will best carry out the purposes of the Institute. The subcommittees shall also review and evaluate
p.000713: the diabetes and endocrine and met- abolic diseases, digestive diseases and nutrition, and kidney, uro- logic,
p.000713: and hematologic diseases programs of the Institute and rec- ommend to the advisory council such changes in the
p.000713: administration of such programs as the subcommittees determine are necessary.
p.000713: BIENNIAL REPORT
p.000713: SEC. 433. ø285c–7¿ The Director of the Institute shall prepare for inclusion in the biennial report made under
p.000713: section 407 a de- scription of the Institute’s activities—
p.000713: (1) under the current diabetes plan under the National Di- abetes Mellitus Research and Education Act; and
p.000713: (2) under the current digestive diseases plan formulated under the Arthritis, Diabetes, and Digestive
p.000713: Diseases Amend- ments of 1976.
p.000713: The description submitted by the Director shall include an evalua- tion of the activities of the centers supported
p.000713: under section 431.
p.000713: NUTRITIONAL DISORDERS PROGRAM
p.000713: SEC. 434. ø285c–8¿ (a) The Director of the Institute, in con- sultation with the Director of NIH, shall
p.000713: establish a program of conducting and supporting research, training, health information dissemination, and
p.000713: other activities with respect to nutritional dis- orders, including obesity.
p.000713: (b) In carrying out the program established under subsection (a), the Director of the Institute shall conduct
p.000713: and support each of the activities described in such subsection.
p.000713: (c) In carrying out the program established under subsection (a), the Director of the Institute shall
p.000713: carry out activities to facili- tate and enhance knowledge and understanding of nutritional dis- orders,
p.000713: including obesity, on the part of health professionals, pa- tients, and the public through the effective
p.000713: dissemination of infor- mation.
p.000713:
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p.000713:
p.000713: January 30, 2020
p.000713: JUVENILE DIABETES
p.000713: SEC. 434A. ø285c–9¿ (a) LONG-TERM EPIDEMIOLOGY STUDIES.—
p.000713: The Director of the Institute shall conduct or support long-term ep- idemiology studies in which individuals with
p.000713: or at risk for type 1, or juvenile, diabetes are followed for 10 years or more. Such studies shall investigate
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p.000717: skeletal diseases. For purposes of this section, the term ‘‘mod- ernization’’ means the alteration,
p.000717: remodeling, improvement, expan- sion, and repair of existing buildings and the provision of equip- ment for
p.000717: such buildings to the extent necessary to make them suit- able for use as centers described in the preceding sentence.
p.000717: (b) Each center assisted under this section shall—
p.000717: (1)(A) use the facilities of a single institution or a consor- tium of cooperating institutions, and (B)
p.000717: meet such qualifica- tions as may be prescribed by the Secretary; and
p.000717: (2) conduct—
p.000717: (A) basic and clinical research into the cause, diag- nosis, early detection, prevention, control, and
p.000717: treatment of and rehabilitation from arthritis and musculoskeletal dis- eases and complications resulting
p.000717: from arthritis and mus-
p.000717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000717:
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p.000719: 719
p.000719: PUBLIC HEALTH SERVICE ACT
p.000719: Sec. 441
p.000719:
p.000719: culoskeletal diseases, including research into implantable biomaterials and biomechanical and other
p.000719: orthopedic pro- cedures;
p.000719: (B) training programs for physicians, scientists, and other health and allied health professionals;
p.000719: (C) information and continuing education programs for physicians and other health and allied health professionals who
p.000719: provide care for patients with arthritis and musculo- skeletal diseases; and
p.000719: (D) programs for the dissemination to the general pub- lic of information—
p.000719: (i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treat- ment, and
p.000719: of following an appropriate regimen; and
p.000719: (ii) to discourage the promotion and use of unap- proved and ineffective diagnostic, preventive, treat-
p.000719: ment, and control methods and unapproved and inef- fective drugs and devices.
p.000719: A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000719: enrolled in training programs de- scribed in paragraph (2)(B).
p.000719: (c) Each center assisted under this section may conduct pro- grams to—
p.000719: (1) establish the effectiveness of new and improved meth- ods of detection, referral, and diagnosis of
p.000719: individuals with a risk of developing arthritis and musculoskeletal diseases;
p.000719: (2) disseminate the results of research, screening, and other activities, and develop means of
p.000719: standardizing patient data and recordkeeping; and
p.000719: (3) develop community consultative services to facilitate the referral of patients to centers for treatment.
p.000719: (d) The Director of the Institute shall, insofar as practicable, provide for an equitable geographical
p.000719: distribution of centers as- sisted under this section. The Director shall give appropriate con- sideration
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p.000719: related activities of the Institute with respect to lupus.
p.000719: (b) COORDINATION WITH OTHER INSTITUTES.—The Director of the Institute shall coordinate the activities of
p.000719: the Director under subsection (a) with similar activities conducted by the other na- tional research
p.000719: institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000719: respon- sibilities that are related to lupus.
p.000719: (c) PROGRAMS FOR LUPUS.—In carrying out subsection (a), the Director of the Institute shall conduct or
p.000719: support research to ex- pand the understanding of the causes of, and to find a cure for, lupus.
p.000719: Activities under such subsection shall include conducting and supporting the following:
p.000719: (1) Research to determine the reasons underlying the ele- vated prevalence of lupus in women, including
p.000719: African-Amer- ican women.
p.000719: (2) Basic research concerning the etiology and causes of the disease.
p.000719: (3) Epidemiological studies to address the frequency and natural history of the disease and the
p.000719: differences among the sexes and among racial and ethnic groups with respect to the disease.
p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
p.000719:
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
p.000719: members who are parents of children with arthritis.
p.000719: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in health
p.000719: education, nurs- ing, data systems, public information, or community program development.
p.000719: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000719:
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p.000721: 721
p.000721: PUBLIC HEALTH SERVICE ACT
p.000721: Sec. 442
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p.000721: January 30, 2020
p.000721: (2) The following shall be ex officio members of the Advi- sory Board:
p.000721: (A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and
p.000721: Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the
p.000721: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000721: Health Affairs (or the designees of such officers), and
p.000721: (B) such other officers and employees of the United States as the Secretary determines necessary for the Advi-
...

p.000721: accordance with subsections (b) and (d), to the Advisory Board established under subsection (a).
p.000721: JUVENILE ARTHRITIS AND RELATED CONDITIONS
p.000721: SEC. 442A. ø285d–8¿ (a) EXPANSION AND COORDINATION OF AC-
p.000721: TIVITIES.—The Director of the Institute, in coordination with the Director of the National Institute of
p.000721: Allergy and Infectious Dis- eases, shall expand and intensify the programs of such Institutes with respect
p.000721: to research and related activities concerning juvenile arthritis and related conditions.
p.000721: (b) COORDINATION.—The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such
p.000721: subsection and consult with the Arthritis and Musculoskeletal Diseases Inter- agency Coordinating Committee.
p.000721: Subpart 5—National Institute on Aging
p.000721: PURPOSE OF THE INSTITUTE
p.000721:
p.000721: SEC. 443. ø285e¿ The general purpose of the National Institute on Aging (hereafter in this subpart referred to
p.000721: as the ‘‘Institute’’) is the conduct and support of biomedical, social, and behavioral re- search, training, health
p.000721: information dissemination, and other pro- grams with respect to the aging process and the diseases and other
p.000721: special problems and needs of the aged.
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p.000721: January 30, 2020
p.000721: SPECIAL FUNCTIONS
p.000721: SEC. 444. ø285e–1¿ (a) In carrying out the training responsibil- ities under this Act or any other Act for
p.000721: health and allied health professions personnel, the Secretary shall take appropriate steps to insure the education
p.000721: and training of adequate numbers of allied health, nursing, and paramedical personnel in the field of
p.000721: health care for the aged.
p.000721: (b) The Director of the Institute shall conduct scientific studies to measure the impact on the biological,
p.000721: medical, social, and psy-
p.000721: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000723: 723
p.000723: PUBLIC HEALTH SERVICE ACT
p.000723: Sec. 445
p.000723:
p.000723: chological aspects of aging of programs and activities assisted or conducted by the Department of Health and
p.000723: Human Services.
p.000723: (c) The Director of the Institute shall carry out public informa- tion and education programs designed to disseminate
p.000723: as widely as possible the findings of research sponsored by the Institute, other relevant aging research
p.000723: and studies, and other information about the process of aging which may assist elderly and near-elderly per- sons
p.000723: in dealing with, and all Americans in understanding, the problems and processes associated with growing older.
p.000723: (d) The Director of the Institute shall make grants to public and private nonprofit institutions to
p.000723: conduct research relating to Alzheimer’s Disease.
p.000723: ALZHEIMER’S DISEASE CENTERS
p.000723: SEC. 445. ø285e–2¿ (a)(1) The Director of the Institute may enter into cooperative agreements with and
p.000723: make grants to public or private nonprofit entities (including university medical centers) to pay all or part
p.000723: of the cost of planning, establishing, or strength- ening, and providing basic operating support (including staffing)
p.000723: for centers for basic and clinical research (including multidisciplinary research) into, training in, and
p.000723: demonstration of advanced diag- nostic, prevention, and treatment methods for Alzheimer’s disease.
p.000723: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000723: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000723: (b)(1) Federal payments made under a cooperative agreement or grant under subsection (a) may, with respect to
p.000723: Alzheimer’s dis- ease, be used for—
p.000723: (A) diagnostic examinations, patient assessments, patient care costs, and other costs necessary for
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p.000731: Plan’’) for the conduct, support, and co-
p.000731: ordination of medical rehabilitation research.
p.000731: (2) The Research Plan shall—
p.000731: (A) identify current medical rehabilitation research activi- ties conducted or supported by the Federal
p.000731: Government, oppor- tunities and needs for additional research, and priorities for such research;
p.000731: (B) make recommendations for the coordination of such re- search conducted or supported by the National
p.000731: Institutes of Health and other agencies of the Federal Government; and
p.000731: (C) include goals and objectives for conducting, supporting, and coordinating medical rehabilitation research,
p.000731: consistent with the purpose described in subsection (b).
p.000731: (3)(A) Not later than 18 months after the date of the enact- ment of the National Institutes of Health
p.000731: Revitalization Amend- ments of 1990, 33 the Director of the Institute shall transmit the Research Plan
p.000731: to the Director of NIH, who shall submit the Plan to the President and the Congress.
p.000731: (B) Subparagraph (A) shall be carried out independently of the process of reporting that is required in sections 403
p.000731: and 407.
p.000731: (4) The Director of the Center, in consultation with the Direc- tor of the Institute, the coordinating committee
p.000731: established under subsection (e), and the advisory board established under subsection (f), shall revise and update
p.000731: the Research Plan periodically, as ap- propriate, or not less than every 5 years. Not later than 30
p.000731: days after the Research Plan is so revised and updated, the Director of the Center shall transmit the
p.000731: revised and updated Research Plan to the President, the Committee on Health, Education, Labor, and Pensions of
p.000731: the Senate, and the Committee on Energy and Com- merce of the House of Representatives.
p.000731: (5) The Director of the Center, in consultation with the Direc- tor of the Institute, shall, prior to revising
p.000731: and updating the Re- search Plan, prepare a report for the coordinating committee estab- lished under subsection
p.000731: (e) and the advisory board established under subsection (f) that describes and analyzes the progress dur-
p.000731: ing the preceding fiscal year in achieving the goals and objectives
p.000731:
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p.000731: January 30, 2020
p.000731: 33 So in law. No Act with such a short title was enacted during 1990. The probable intent of the Congress was to make a
p.000731: reference to Public Law 101–613, the National Institutes of Health Amendments of 1990, which added section 452 and
p.000731: which was enacted November 16, 1990.
p.000731: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000731: Sec. 452 PUBLIC HEALTH SERVICE ACT 732
p.000731:
p.000731: described in paragraph (2)(C) and includes expenditures for reha- bilitation research at the National
p.000731: Institutes of Health. The report shall include recommendations for revising and updating the Re- search Plan,
p.000731: and such initiatives as the Director of the Center and the Director of the Institute determine appropriate. In
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p.000733: contraception and centers to conduct activities for the purpose of improving methods of diagnosis and
p.000733: treatment of infertility.
p.000733: (b) In carrying out subsection (a), the Director of the Institute shall, subject to the extent of amounts made
p.000733: available in appropria- tions Acts, provide for the establishment of three centers with re- spect to
p.000733: contraception and for two centers with respect to infer- tility.
p.000733: (c)(1) Each center assisted under this section shall, in carrying out the purpose of the center involved—
p.000733: (A) conduct clinical and other applied research, including—
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000733: Sec. 452B PUBLIC HEALTH SERVICE ACT 734
p.000733:
p.000733: (i) for centers with respect to contraception, clinical trials of new or improved drugs and devices for
p.000733: use by males and females (including barrier methods); and
p.000733: (ii) for centers with respect to infertility, clinical trials of new or improved drugs and devices for the
p.000733: diagnosis and treatment of infertility in males and females;
p.000733: (B) develop protocols for training physicians, scientists, nurses, and other health and allied health
p.000733: professionals;
p.000733: (C) conduct training programs for such individuals;
p.000733: (D) develop model continuing education programs for such professionals; and
p.000733: (E) disseminate information to such professionals and the public.
p.000733: (2) A center may use funds provided under subsection (a) to provide stipends for health and allied health
p.000733: professionals enrolled in programs described in subparagraph (C) of paragraph (1), and to provide fees to
p.000733: individuals serving as subjects in clinical trials conducted under such paragraph.
p.000733: (d) The Director of the Institute shall, as appropriate, provide for the coordination of information
p.000733: among the centers assisted under this section.
p.000733: (e) Each center assisted under subsection (a) shall use the fa- cilities of a single institution, or be
p.000733: formed from a consortium of co- operating institutions, meeting such requirements as may be pre- scribed by the
p.000733: Director of the Institute.
p.000733: (f) Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be
p.000733: extended for one or more additional periods not exceeding 5 years if the operations of such center have
p.000733: been reviewed by an appropriate technical and scientific peer review group established by the Director and if
p.000733: such group has recommended to the Director that such period should be extended.
p.000733:
p.000733: PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
p.000733: SEC. 452B. ø285g–6¿ The Director of the Institute shall estab- lish and maintain within the Institute an
p.000733: intramural laboratory and clinical research program in obstetrics and gynecology.
p.000733: CHILD HEALTH RESEARCH CENTERS
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p.000737: disease and the ear- lier detection of pending eye abnormalities. The focus of work under this paragraph
p.000737: shall require that ophthalmologists have training in the most up-to-date molecular and cell biological methods.
p.000737: (2) Establishing new frontiers in technology, such as video- based diagnostic and research resources, to—
p.000737: (A) provide improved patient care;
p.000737: (B) provide for the evaluation of retinal physiology and its affect on diabetes; and
p.000737: (C) provide for the assessment of risks for the develop- ment and progression of diabetic eye disease and a
p.000737: more immediate evaluation of various therapies aimed at pre- venting diabetic eye disease.
p.000737: Such technologies shall be designed to permit evaluations to be performed both in humans and in animal models.
p.000737: (3) The translation of the results of vision research into the improved care of patients with diabetic
p.000737: eye disease. Such translation shall require the application of institutional re- sources that encompass
p.000737: patient care, clinical research and basic laboratory research.
p.000737: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000737:
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p.000737: Sec. 457 PUBLIC HEALTH SERVICE ACT 738
p.000737:
p.000737: (4) The conduct of research concerning the outcomes of eye care treatments and eye health education programs as they
p.000737: re- late to patients with diabetic eye disease, including the evalua- tion of regional approaches to such research.
p.000737: (c) AUTHORIZED EXPENDITURES.—The purposes for which a grant under subsection (a) may be expended include
p.000737: equipment for the research described in such subsection.
p.000737: Subpart 10—National Institute of Neurological Disorders and Stroke
p.000737: PURPOSE OF THE INSTITUTE
p.000737:
p.000737: SEC. 457. ø285j¿ The general purpose of the National Institute of Neurological Disorders and Stroke (hereafter in this
p.000737: subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of research, training, health information
p.000737: dissemination, and other programs with respect to neurological disease and disorder and stroke.
p.000737: SPINAL CORD REGENERATION RESEARCH
p.000737: SEC. 458. ø285j–1¿ The Director of the Institute shall conduct and support research into spinal cord
p.000737: regeneration.
p.000737: BIOENGINEERING RESEARCH
p.000737: SEC. 459. ø285j–2¿ The Director of the Institute shall make grants or enter into contracts for research
p.000737: on the means to over- come paralysis of the extremities through electrical stimulation and the use of computers.
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p.000737: January 30, 2020
p.000737: RESEARCH ON MULTIPLE SCLEROSIS
p.000737: SEC. 460. ø285j–3¿ The Director of the Institute shall conduct and support research on multiple sclerosis,
p.000737: especially research on effects of genetics and hormonal changes on the progress of the dis- ease.
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p.000741: processes. For purposes of this section, the term ‘‘modernization’’ means the alter- ation, remodeling, improvement,
p.000741: expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent
p.000741: necessary to make them suitable for use as centers de- scribed in the preceding sentence.
p.000741: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000741: Sec. 464C PUBLIC HEALTH SERVICE ACT 742
p.000741:
p.000741: (b) Each center assisted under this section shall—
p.000741: (1) use the facilities of a single institution or a consortium of cooperating institutions; and
p.000741: (2) meet such qualifications as may be prescribed by the Secretary.
p.000741: (c) Each center assisted under this section shall, at least, con- duct—
p.000741: (1) basic and clinical research into the cause diagnosis, early detection, prevention, control and
p.000741: treatment of disorders of hearing and other communication processes and complica- tions resulting from such
p.000741: disorders, including research into re- habilitative aids, implantable biomaterials, auditory speech
p.000741: processors, speech production devices, and other otolaryngologic procedures;
p.000741: (2) training programs for physicians, scientists, and other health and allied health professionals;
p.000741: (3) information and continuing education programs for physicians and other health and allied health
p.000741: professionals who will provide care for patients with disorders of hearing or other communication processes; and
p.000741: (4) programs for the dissemination to the general public of information—
p.000741: (A) on the importance of early detection of disorders of hearing and other communication processes, of seeking
p.000741: prompt treatment, rehabilitation, and of following an ap- propriate regimen; and
p.000741: (B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect
p.000741: dis- orders of hearing or other communication processes.
p.000741: (d) A center may use funds provided under subsection (a) to provide stipends for health professionals
p.000741: enrolled in training pro- grams described in subsection (c)(2).
p.000741: (e) Each center assisted under this section may conduct pro- grams—
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p.000741: January 30, 2020
p.000741: (1) to establish the effectiveness of new and improved methods of detection, referral, and diagnosis of
p.000741: individuals at risk of developing disorders of hearing or other communication processes; and
p.000741: (2) to disseminate the results of research, screening, and other activities, and develop means of
p.000741: standardizing patient data and recordkeeping.
p.000741: (f) The Director of the Institute shall, to the extent practicable, provide for an equitable geographical
p.000741: distribution of centers as- sisted under this section. The Director shall give appropriate con- sideration
p.000741: to the need for centers especially suited to meeting the needs of the elderly, and of children
p.000741: (particularly with respect to their education and training), affected by disorders of hearing or other
p.000741: communication processes.
p.000741: (g) Support of a center under this section may be for a period not to exceed seven years. Such period may
p.000741: be extended by the Di- rector of the Institute for one or more additional periods of not more than five
p.000741: years if the operations of such center have been re- viewed by an appropriate technical and scientific peer review
p.000741: group established by the Director, with the advice of the Institute’s advi-
p.000741: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000743: 743
p.000743: PUBLIC HEALTH SERVICE ACT
p.000743: Sec. 464D
p.000743:
p.000743: sory council, if such group has recommended to the Director that such period should be extended.
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p.000743: January 30, 2020
p.000743: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY BOARD
p.000743: SEC. 464D. ø285m–4¿ (a) The Secretary shall establish in the Institute the National Deafness and Other
p.000743: Communications Dis- orders Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000743: (b) The Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000743: follows:
p.000743: (1) The Secretary shall appoint—
p.000743: (A) twelve members from individuals who are sci- entists, physicians, and other health and rehabilitation
p.000743: professionals, who are not officers or employees of the United States, and who represent the specialties
p.000743: and dis- ciplines relevant to deafness and other communication dis- orders, including not less than two persons with a
p.000743: commu- nication disorder; and
p.000743: (B) six members from the general public who are knowledgeable with respect to such disorders, including
p.000743: not less than one person with a communication disorder and not less than one person who is a parent
p.000743: of an indi- vidual with such a disorder.
p.000743: Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in
p.000743: diagnoses and re- habilitation of communication disorders, education of the hear- ing, speech, or language
p.000743: impaired, public health, public infor- mation, community program development, occupational haz- ards to
p.000743: communications senses, or the aging process.
p.000743: (2) The following shall be ex officio members of each Advi- sory Board:
p.000743: (A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness
p.000743: and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the
p.000743: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000743: Health Affairs (or the designees of such officers).
p.000743: (B) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000743: sory Board to carry out its functions.
p.000743: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000743: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000743: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000743: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000743: engaged in the per- formance of their duties as members of the Board.
p.000743: (d) The term of office of an appointed member of the Advisory Board is four years, except that no term of
p.000743: office may extend be- yond the expiration of the Advisory Board. Any member appointed
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p.000745: Sec. 464H PUBLIC HEALTH SERVICE ACT 746
p.000745:
p.000745: (3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to
p.000745: individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse
p.000745: and Alcoholism, giving spe- cial consideration to projects relating to—
p.000745: (A) the relationship between alcohol abuse and domes- tic violence,
p.000745: (B) the effects of alcohol use during pregnancy,
p.000745: (C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of
p.000745: health services,
p.000745: (D) the relationship between the abuse of alcohol and other drugs,
p.000745: (E) the effect on the incidence of alcohol abuse and al- coholism of social pressures, legal requirements respecting
p.000745: the use of alcoholic beverages, the cost of such beverages, and the economic status and education of
p.000745: users of such beverages,
p.000745: (F) the interrelationship between alcohol use and other health problems,
p.000745: (G) the comparison of the cost and effectiveness of var- ious treatment methods for alcoholism and alcohol abuse
p.000745: and the effectiveness of prevention and intervention pro- grams for alcoholism and alcohol abuse, and
p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
...

p.000747: coordination of such research among such disciplines;
p.000747:
p.000747:
p.000747:
p.000747: January 30, 2020
p.000747: 39 Now codified to section 3324 of title 31, United States Code.
p.000747: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000747:
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p.000747: Sec. 464L PUBLIC HEALTH SERVICE ACT 748
p.000747:
p.000747: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000747: facili- ties) to carry out the research plan contained in the appli- cation,
p.000747: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000747: alco- holism and other alcohol problems;
p.000747: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000747: alco- holism and other alcohol problems;
p.000747: (E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol
p.000747: problems for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other
p.000747: specialized grad- uate students; and
p.000747: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000747: social service fields as the Secretary may require. 40
p.000747: (2) the application contains a detailed five-year plan for re- search relating to alcoholism and other alcohol
p.000747: problems.
p.000747: (b) The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to
p.000747: Centers which have been designated under this section. No funds provided under a grant under this subsection may be
p.000747: used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For
p.000747: the purposes of the preceding sentence, the term ‘‘con- struction’’ has the meaning given that term by section
p.000747: 701(1). 41 The Secretary shall include in the grants made under this section for fiscal year beginning after
p.000747: September 30, 1981, a grant to a des- ignated Center for research on the effects of alcohol on the elderly.
p.000747: Subpart 15—National Institute on Drug Abuse
p.000747: PURPOSE OF INSTITUTE
p.000747: SEC. 464L. ø285o¿ (a) IN GENERAL.—The general purpose of the National Institute on Drug Abuse (hereafter in
p.000747: this subpart re- ferred to as the ‘‘Institute’’) is the conduct and support of bio- medical and behavioral
p.000747: research, health services research, research training, and health information dissemination with respect to the
...

p.000749: facili- ties) to carry out the research plan contained in the appli- cation;
p.000749: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000749: drug abuse;
p.000749: (D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on
p.000749: drug abuse;
p.000749: (E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse
p.000749: for undergraduate and graduate students, and medical and os- teopathic, nursing, social work, and other specialized
p.000749: grad- uate students; and
p.000749: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000749:
p.000749:
p.000749:
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p.000749:
p.000749: Sec. 464N PUBLIC HEALTH SERVICE ACT 750
p.000749:
p.000749: (F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and
p.000749: social service fields as the Secretary may require. 42
p.000749: (2) the application contains a detailed five-year plan for re- search relating to drug abuse.
p.000749: (b) GRANTS.—The Director of the Institute shall, under such conditions as the Secretary may reasonably
p.000749: require, make annual grants to Centers which have been designated under this section. No funds provided
p.000749: under a grant under this subsection may be used for the purchase of any land or the purchase,
p.000749: construction, preservation, or repair of any building. For the purposes of the pre- ceding sentence, the term
p.000749: ‘‘construction’’ has the meaning given that term by section 701(1). 43
p.000749: (c) DRUG ABUSE AND ADDITION 44 RESEARCH.—
p.000749: (1) GRANTS OR COOPERATIVE AGREEMENTS.—The Director of the Institute may make grants or enter into cooperative agree-
p.000749: ments to expand the current and ongoing interdisciplinary re- search and clinical trials with treatment
p.000749: centers of the Na- tional Drug Abuse Treatment Clinical Trials Network relating to drug abuse and addiction,
p.000749: including related biomedical, be- havioral, and social issues.
p.000749: (2) USE OF FUNDS.—Amounts made available under a grant or cooperative agreement under paragraph (1)
...

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p.000755:
p.000755:
p.000755: January 30, 2020
p.000755:
p.000755: (A) the Secretary, the Director of NIH, the Director of the Institute, the chief nursing officer of the
p.000755: Department of Vet- erans Affairs, the Assistant Secretary of Defense for Health Af- fairs, the Director of the
p.000755: Division of Nursing of the Health Re- sources and Services Administration (or the designees of such officers),
p.000755: and
p.000755: (B) such additional officers or employees of the United States as the Secretary determines necessary for
p.000755: the advisory council to effectively carry out its functions.
p.000755: (3) The members of the advisory council who are not ex officio members shall be appointed as follows:
p.000755: (A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of
p.000755: the health and scientific disciplines (including public health and the be- havioral or social sciences)
p.000755: relevant to the activities of the In- stitute. Of the members appointed pursuant to this subpara- graph,
p.000755: at least seven shall be professional nurses who are rec- ognized experts in the area of clinical practice, education,
p.000755: or re- search.
p.000755: (B) One-third of the members shall be appointed by the Secretary from the general public and shall
p.000755: include leaders in fields of public policy, law, health policy, economics, and man- agement.
p.000755: (4) Members of the advisory council who are officers or employ- ees of the United States shall not receive any
p.000755: compensation for service on the advisory council. The other members of the advisory council shall receive, for
p.000755: each day (including traveltime) they are engaged in the performance of the functions of the advisory council,
p.000755: compensation at rates not to exceed the daily equivalent of the an- nual rate in effect for grade GS–18 of the General
p.000755: Schedule.
p.000755: (c) The term of office of an appointed member of the advisory council is four years, except that any
p.000755: member appointed to fill a vacancy for an unexpired term shall be appointed for the remain- der of such
p.000755: term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the
p.000755: terms of the members do not all expire in the same year. A member may serve after the expiration of
p.000755: the member’s term until a successor has taken office. A member who has been appointed for a term of
p.000755: four years may not be reappointed to an advisory council before two years from the date of expiration
p.000755: of such term of office. If a vacancy occurs in the advisory council among the appointed mem- bers, the
p.000755: Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
p.000755: (d) The chairman of the advisory council shall be selected by the Secretary from among the appointed members,
...

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p.000763: Sec. 464z–4 PUBLIC HEALTH SERVICE ACT 764
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p.000763: January 30, 2020
p.000763:
p.000763: conducting minority health disparities research and other health disparities research.
p.000763: (c) CENTERS OF EXCELLENCE.—
p.000763: (1) IN GENERAL.—For purposes of this section, a designated biomedical and behavioral research institution is a
p.000763: biomedical and behavioral research institution that—
p.000763: (A) has a significant number of members of minority health disparity populations or other health disparity pop-
p.000763: ulations enrolled as students in the institution (including individuals accepted for enrollment in the
p.000763: institution);
p.000763: (B) has been effective in assisting such students of the institution to complete the program of education or
p.000763: train- ing and receive the degree involved;
p.000763: (C) has made significant efforts to recruit minority students to enroll in and graduate from the
p.000763: institution, which may include providing means-tested scholarships and other financial assistance as appropriate;
p.000763: and
p.000763: (D) has made significant recruitment efforts to in- crease the number of minority or other members of health
p.000763: disparity populations serving in faculty or administrative positions at the institution.
p.000763: (2) CONSORTIUM.—Any designated biomedical and behav- ioral research institution involved may, with other
p.000763: biomedical and behavioral institutions (designated or otherwise), including tribal health programs, form a consortium
p.000763: to receive an award under subsection (a).
p.000763: (3) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Director of the
p.000763: Institute for purposes of determining whether institutions meet the con- ditions described in paragraph (1), this
p.000763: section may not, with respect to minority health disparity populations or other health disparity populations, be
p.000763: construed to authorize, require, or prohibit the use of such criteria in any program other than the program
p.000763: established in this section.
p.000763: (d) DURATION OF GRANT.—The period during which payments are made under a grant under subsection (a) may
p.000763: not exceed 5 years. Such payments shall be subject to annual approval by the Director of the Institute
p.000763: and to the availability of appropriations for the fiscal year involved to make the payments.
...

p.000765:
p.000765: January 30, 2020 As Amended Through P.L. 116-94,
p.000765: Enacted December 20, 2019
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p.000767: 767
p.000767: PUBLIC HEALTH SERVICE ACT
p.000767: Sec. 467
p.000767:
p.000767: BOARD OF REGENTS
p.000767: SEC. 466. ø286a¿ (a)(1)(A) The Board of Regents of the Na- tional Library of Medicine consists of ex
p.000767: officio members and ten members appointed by the Secretary.
p.000767: (B) The ex officio members are the Surgeons General of the Public Health Service, the Army, the Navy, and the
p.000767: Air Force, the Chief Medical Director of the Department of Veterans Affairs, the Dean of the Uniformed
p.000767: Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social
p.000767: Sciences of the National Science Foundation, the Director of the National Agricultural Library, and the
p.000767: Librarian of Congress (or their designees).
p.000767: (C) The appointed members shall be selected from among lead- ers in the various fields of the fundamental sciences,
p.000767: medicine, den- tistry, public health, hospital administration, pharmacology, health communications technology, or
p.000767: scientific or medical library work, or in public affairs. At least six of the appointed members shall be se- lected
p.000767: from among leaders in the fields of medical, dental, or public health research or education.
p.000767: (2) The Board shall annually elect one of the appointed mem- bers to serve as chairman until the next
p.000767: election. The Secretary shall designate a member of the Library staff to act as executive secretary of the
p.000767: Board.
p.000767: (b) The Board shall advise, consult with, and make rec- ommendations to the Secretary on matters
p.000767: of policy in regard to the Library, including such matters as the acquisition of materials for the Library, the
p.000767: scope, content, and organization of the Li- brary’s services, and the rules under which its materials,
p.000767: publica- tions, facilities, and services shall be made available to various kinds of users. The Secretary
p.000767: shall include in the annual report of the Secretary to the Congress a statement covering the rec-
p.000767: ommendations made by the Board and the disposition thereof. The Secretary may use the services of any member of the
p.000767: Board in con- nection with matters related to the work of the Library, for such periods, in addition to
p.000767: conference periods, as the Secretary may de- termine.
p.000767: (c) Each appointed member of the Board shall hold office for a term of four years, except that any
p.000767: member appointed to fill a vacancy occurring prior to the expiration of the term for which the predecessor of
p.000767: such member was appointed shall be appointed for the remainder of such term. None of the appointed members shall
p.000767: be eligible for reappointment within one year after the end of the preceding term of such member.
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p.000767: January 30, 2020
p.000767: LIBRARY FACILITIES
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p.000769: Sec- retary shall prescribe.
p.000769: ASSISTANCE FOR SPECIAL SCIENTIFIC PROJECTS, AND FOR RESEARCH AND DEVELOPMENT IN MEDICAL LIBRARY
p.000769: SCIENCE AND RELATED FIELDS
p.000769: SEC. 473. ø286b–4¿ (a) The Secretary shall make grants to physicians and other practitioners in the sciences
p.000769: related to health, to scientists, and to public or nonprofit private institutions on be- half of such
p.000769: physicians, other practitioners, and scientists for the compilation of existing, or the writing of original,
p.000769: contributions re- lating to scientific, social, or cultural advancements in sciences re- lated to health. In making
p.000769: such grants, the Secretary shall make appropriate arrangements under which the facilities of the Library and the
p.000769: facilities of libraries of public and private nonprofit institu- tions of higher learning may be made available in
p.000769: connection with the projects for which such grants are made.
p.000769: (b) The Secretary shall make grants to appropriate public or private nonprofit institutions and enter
p.000769: into contracts with appro- priate persons, for purposes of carrying out projects of research, in- vestigations, and
p.000769: demonstrations in the field of medical library science and related activities and for the development of new
p.000769: tech- niques, systems, and equipment, for processing, storing, retrieving, and distributing information
p.000769: pertaining to sciences related to health.
p.000769: (c)(1) The Secretary shall make grants to public or nonprofit private institutions for the purpose of
p.000769: carrying out projects of re- search on, and development and demonstration of, new education technologies.
p.000769: (2) The purposes for which a grant under paragraph (1) may be made include projects concerning—
p.000769: (A) computer-assisted teaching and testing of clinical com- petence at health professions and research institutions;
p.000769: (B) the effective transfer of new information from research laboratories to appropriate clinical applications;
p.000769: (C) the expansion of the laboratory and clinical uses of computer-stored research databases; and
p.000769: (D) the testing of new technologies for training health care professionals.
p.000769: (3) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees
p.000769: to make the projects available with respect to—
p.000769: (A) assisting in the training of health professions students;
p.000769: and
p.000769: (B) enhancing and improving the capabilities of health pro-
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p.000769: January 30, 2020
p.000769: fessionals regarding research and teaching.
p.000769: GRANTS FOR ESTABLISHING, EXPANDING, AND IMPROVING THE BASIC RESOURCES OF MEDICAL LIBRARIES AND RELATED
p.000769: INSTRUMENTAL- ITIES
p.000769: SEC. 474. ø286b–5¿ (a) The Secretary shall make grants of money, materials, or both, to public or private
p.000769: nonprofit medical li-
p.000769: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000769: Sec. 475 PUBLIC HEALTH SERVICE ACT 770
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p.000771: copies of bio- medical materials which qualified requesters may retain.
p.000771: (2) The Secretary, in awarding grants and contracts under this section, shall give priority to medical libraries
p.000771: having the greatest potential of fulfilling the needs for regional medical libraries. In de- termining the priority
p.000771: to be assigned to any medical library, the Secretary shall consider—
p.000771: (A) the adequacy of the library (in terms of collections, per- sonnel, equipment, and other facilities) as a basis for
p.000771: a regional medical library; and
p.000771: (B) the size and nature of the population to be served in the region in which the library is located.
p.000771: (d) Grants and contracts under this section for basic resource materials to a library may not exceed—
p.000771: (1) 50 percent of the library’s annual operating expense (exclusive of Federal financial assistance under
p.000771: this part) for the preceding year; or
p.000771: (2) in case of the first year in which the library receives a grant under this section for basic resource
p.000771: materials, 50 per- cent of its average annual operating expenses over the past three years (or if it had
p.000771: been in operation for less than three years, its annual operating expenses determined by the Sec- retary
p.000771: in accordance with regulations).
p.000771:
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p.000771: January 30, 2020
p.000771: FINANCIAL SUPPORT OF BIOMEDICAL SCIENTIFIC PUBLICATIONS
p.000771: SEC. 476. ø286b–7¿ (a) The Secretary, with the advice of the Board, shall make grants to, and enter
p.000771: into appropriate contracts with, public or private nonprofit institutions of higher education
p.000771: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000771:
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p.000771: Sec. 477 PUBLIC HEALTH SERVICE ACT 772
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p.000771: January 30, 2020
p.000771:
p.000771: and individual scientists for the purpose of supporting biomedical scientific publications of a nonprofit
p.000771: nature and to procure the com- pilation, writing, editing, and publication of reviews, abstracts, in- dices,
p.000771: handbooks, bibliographies, and related matter pertaining to scientific works and scientific developments.
p.000771: (b) Grants under subsection (a) in support of any single peri- odical publication may not be made for more
p.000771: than three years, ex- cept in those cases in which the Secretary determines that further support is necessary to carry
p.000771: out the purposes of subsection (a).
p.000771: GRANT PAYMENTS, RECORDS, AND AUDIT
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p.000777: (B) TRAVEL EXPENSES.—Members of the Board shall be allowed travel expenses, including per diem in lieu of sub-
p.000777: sistence, at rates authorized for persons employed inter- mittently by the Federal Government under
p.000777: section 5703(b) of title 5, United States Code, while away from their homes or regular places of
p.000777: business in the perform- ance of services for the Board.
p.000777: (e) GRANT PROGRAM.—
p.000777: (1) SUPPORTING INNOVATION.—To carry out the purposes described in this section, the Director of the
p.000777: Center shall award contracts, grants, or cooperative agreements to the enti- ties described in paragraph (2), to—
p.000777: (A) promote innovation in technologies supporting the advanced research and development and production
p.000777: of high need cures, including through the development of medical products and behavioral therapies.
p.000777: (B) accelerate the development of high need cures, in- cluding through the development of medical products, be-
p.000777: havioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or
p.000777: (C) help the award recipient establish protocols that comply with Food and Drug Administration standards and
p.000777: otherwise permit the recipient to meet regulatory require- ments at all stages of development, manufacturing, review,
p.000777: approval, and safety surveillance of a medical product.
p.000777: (2) ELIGIBLE ENTITIES.—To receive assistance under para- graph (1), an entity shall—
p.000777: (A) be a public or private entity, which may include a private or public research institution, an institution of
p.000777: higher education, a medical center, a biotechnology com- pany, a pharmaceutical company, a disease advocacy
p.000777: orga-
p.000777: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000779: PUBLIC HEALTH SERVICE ACT
p.000779: Sec. 480
p.000779:
p.000779: nization, a patient advocacy organization, or an academic research institution;
p.000779: (B) submit an application containing—
p.000779: (i) a detailed description of the project for which the entity seeks such grant or contract;
p.000779: (ii) a timetable for such project;
p.000779: (iii) an assurance that the entity will submit—
p.000779: (I) interim reports describing the entity’s— (aa) progress in carrying out the project;
p.000779: and
p.000779: (bb) compliance with all provisions of this
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p.000779: section and conditions of receipt of such grant or contract; and
p.000779: (II) a final report at the conclusion of the grant period, describing the outcomes of the project;
p.000779: and
...

p.000779: be award- ed on a competitive basis.
p.000779: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000779: (1) IN GENERAL.—For purposes of carrying out this section, there are authorized to be appropriated $500,000,000 for
p.000779: fiscal year 2010, and such sums as may be necessary for subsequent fiscal years. Funds appropriated under this
p.000779: section shall be available until expended.
p.000779: (2) LIMITATION ON USE OF FUNDS OTHERWISE APPRO- PRIATED.—No funds appropriated under this Act,
p.000779: other than funds appropriated under paragraph (1), may be allocated to the Cures Acceleration Network.
p.000779: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000781: 781
p.000781: PUBLIC HEALTH SERVICE ACT
p.000781: Sec. 481A
p.000781:
p.000781: OFFICE OF RARE DISEASES
p.000781: SEC. 481. ø287a–1¿ (a) ESTABLISHMENT.—There is established within the Center an office to be known as the Office
p.000781: of Rare Dis- eases (in this section referred to as the ‘‘Office’’), which shall be headed by a Director (in
p.000781: this section referred to as the ‘‘Director’’), appointed by the Director of the Center.
p.000781: (b) DUTIES.—
p.000781: (1) IN GENERAL.—The Director of the Office shall carry out the following:
p.000781: (A) The Director shall recommend an agenda for con- ducting and supporting research on rare diseases
p.000781: through the national research institutes and centers. The agenda shall provide for a broad range of
p.000781: research and education activities, including scientific workshops and symposia to identify research
p.000781: opportunities for rare diseases.
p.000781: (B) The Director shall, with respect to rare diseases, promote coordination and cooperation among the
p.000781: national research institutes and centers and entities whose re- search is supported by such institutes.
p.000781: (C) The Director, in collaboration with the directors of the other relevant institutes and centers of the
p.000781: National Institutes of Health, may enter into cooperative agree- ments with and make grants for regional centers
p.000781: of excel- lence on rare diseases in accordance with section 481A.
p.000781: (D) The Director shall promote the sufficient allocation of the resources of the National Institutes of Health
p.000781: for conducting and supporting research on rare diseases.
p.000781: (E) The Director shall promote and encourage the es- tablishment of a centralized clearinghouse for rare and
p.000781: ge- netic disease information that will provide understandable information about these diseases to the public,
p.000781: medical professionals, patients and families.
p.000781: (2) PRINCIPAL ADVISOR REGARDING ORPHAN DISEASES.— With respect to rare diseases, the Director
p.000781: shall serve as the principal advisor to the Director of NIH and shall provide ad- vice to other relevant
p.000781: agencies. The Director shall provide liai- son with national and international patient, health and sci- entific
p.000781: organizations concerned with rare diseases.
p.000781: (c) DEFINITION.—For purposes of this section, the term ‘‘rare disease’’ means any disease or condition
p.000781: that affects less than 200,000 persons in the United States.
p.000781:
p.000781:
p.000781:
...

p.000781: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000781:
p.000781:
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p.000781:
p.000781: Sec. 481B PUBLIC HEALTH SERVICE ACT 782
p.000781:
p.000781: into, training in, and demonstration of diagnostic, prevention, control, and treatment methods for rare
p.000781: diseases.
p.000781: (2) POLICIES.—A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with
p.000781: policies established by the Director of NIH.
p.000781: (b) COORDINATION WITH OTHER INSTITUTES.—The Director shall coordinate the activities under this section
p.000781: with similar activi- ties conducted by other national research institutes, centers and agencies of the
p.000781: National Institutes of Health and by the Food and Drug Administration to the extent that such institutes,
p.000781: centers and agencies have responsibilities that are related to rare diseases.
p.000781: (c) USES FOR FEDERAL PAYMENTS UNDER COOPERATIVE AGREE- MENTS OR GRANTS.—Federal payments made under a
p.000781: cooperative agreement or grant under subsection (a) may be used for—
p.000781: (1) staffing, administrative, and other basic operating costs, including such patient care costs as
p.000781: are required for re- search;
p.000781: (2) clinical training, including training for allied health professionals, continuing education for health
p.000781: professionals and allied health professions personnel, and information programs for the public with respect to
p.000781: rare diseases; and
p.000781: (3) clinical research and demonstration programs.
p.000781: (d) PERIOD OF SUPPORT; ADDITIONAL PERIODS.—Support of a center under subsection (a) may be for a
p.000781: period of not to exceed 5 years. Such period may be extended by the Director for additional periods of
p.000781: not more than 5 years if the operations of such center have been reviewed by an appropriate technical and
p.000781: scientific peer review group established by the Director and if such group has rec- ommended to the Director that such
p.000781: period should be extended.
p.000781: SEC. 481B. ø287a–3¿ GENERAL CLINICAL RESEARCH CENTERS.
p.000781: (a) GRANTS.—The Director of the Center shall award grants for the establishment of general clinical research centers to
p.000781: provide the infrastructure for clinical research including clinical research train- ing and career enhancement.
p.000781: Such centers shall support clinical studies and career development in all settings of the hospital or
p.000781: academic medical center involved.
p.000781: (b) ACTIVITIES.—In carrying out subsection (a), the Director of National Institutes of Health shall expand the
p.000781: activities of the gen- eral clinical research centers through the increased use of tele- communications and
p.000781: telemedicine initiatives.
p.000781: Subpart 2—John E. Fogarty International Center for Advanced Study in the Health Sciences
p.000781: GENERAL PURPOSE
p.000781: SEC. 482. ø287b¿ The general purpose of the John E. Fogarty International Center for Advanced Study in the
p.000781: Health Sciences is to—
p.000781:
p.000781:
p.000781:
p.000781:
p.000781:
p.000781: January 30, 2020
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p.000785:
p.000785:
p.000785:
p.000785:
p.000785:
p.000785:
p.000785: January 30, 2020
p.000785: ties.
p.000785: The Director of NIH, in coordination with the Director of the Cen- ter, shall designate specific personnel in each
p.000785: Institute to serve as full-time liaisons with the Center in facilitating appropriate coordi- nation and scientific
p.000785: input.
p.000785: (g) DATA SYSTEM; INFORMATION CLEARINGHOUSE.—
p.000785: (1) DATA SYSTEM.—The Director of the Center shall estab- lish a bibliographic system for the collection,
p.000785: storage, and re- trieval of worldwide research relating to complementary and integrative health, diagnostic
p.000785: and prevention modalities, dis- ciplines and systems. Such a system shall be regularly updated and publicly
p.000785: accessible.
p.000785: (2) CLEARINGHOUSE.—The Director of the Center shall es- tablish an information clearinghouse to facilitate and
p.000785: enhance, through the effective dissemination of information, knowledge and understanding of integrative
p.000785: health treatment, diagnostic and prevention practices by health professionals, patients, in- dustry, and the
p.000785: public.
p.000785: (h) RESEARCH CENTERS.—The Director of the Center, after con- sultation with the advisory council for the Center,
p.000785: shall provide support for the development and operation of multipurpose centers to conduct research and other
p.000785: activities described in subsection (a) with respect to complementary and integrative health, diagnostic and
p.000785: prevention modalities, disciplines and systems. The provision of support for the development and operation of
p.000785: such centers shall include accredited complementary and integrative health research and education facilities.
p.000785: (i) AVAILABILITY OF RESOURCES.—After consultation with the Director of the Center, the Director of NIH
p.000785: shall ensure that re- sources of the National Institutes of Health, including laboratory and clinical
p.000785: facilities, fellowships (including research training fel- lowship and junior and senior clinical
p.000785: fellowships), and other re- sources are sufficiently available to enable the Center to appro- priately and
p.000785: effectively carry out its duties as described in sub- section (a). The Director of NIH, in coordination
p.000785: with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time
p.000785: liaisons with the Center in facilitating appro- priate coordination and scientific input.
p.000785: (j) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated
p.000785: to carry out this section for fiscal year 1999 are available for obli- gation through September 30, 2001.
p.000785: Amounts appropriated to carry out this section for fiscal year 2000 are available for obligation through
p.000785: September 30, 2001.
p.000785: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000785:
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p.000785: Sec. 486 PUBLIC HEALTH SERVICE ACT 786
p.000785:
p.000785: PART F—RESEARCH ON WOMEN’S HEALTH
p.000785: SEC. 486. ø287d¿ OFFICE OF RESEARCH ON WOMEN’S HEALTH.
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p.000793: 793
p.000793: PUBLIC HEALTH SERVICE ACT
p.000793: Sec. 487B
p.000793:
p.000793: than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) general research;
p.000793: (ii) research on acquired immune deficiency syn- drome; and
p.000793: (iii) clinical research conducted by appropriately qualified health professional who are from disadvan-
p.000793: taged backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
p.000793: elimi- nate one or more subcategories provided for in paragraph (1) due to changes in workforce or
p.000793: scientific needs related to bio- medical research. The Director may establish other sub- category
p.000793: areas based on workforce and scientific priorities if the total number of subcategories does not exceed the
p.000793: number of subcategories listed in paragraph (1).
p.000793: (c) LIMITATION.—The Director of the National Institutes of Health may not enter into a contract with a
p.000793: health professional pursuant to subsection (a) unless such professional has a substan- tial amount of education
p.000793: loans relative to income (as determined pursuant to guidelines issued by the Director).
p.000793: (d) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan
p.000793: Repayment Program es- tablished in subpart III of part D of title III, the provisions of such subpart shall, except
p.000793: as inconsistent with subsection (a) of this sec- tion, apply to the program established in such subsection (a) in the
p.000793: same manner and to the same extent as such provisions apply to the National Health Service Corps Loan
p.000793: Repayment Program es- tablished in such subpart.
p.000793: (e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for carrying out this section shall remain available until
p.000793: the expiration of the second fiscal year beginning after the fiscal year for which such amounts are made
p.000793: available.
p.000793: EXTRAMURAL LOAN REPAYMENT PROGRAM 55
p.000793: SEC. 487B. ø288–2¿ (a) IN GENERAL.—The Director of the Na- tional Institutes of Health shall, as appropriate and based
p.000793: on work- force and scientific priorities, carry out a program through the sub- categories listed in subsection
p.000793: (b)(1) (or modified subcategories as provided for in subsection (b)(2)), of entering into contracts with
p.000793: qualified health professionals under which such health profes- sionals agree to conduct research in
p.000793: consideration of the Federal Government agreeing to repay, for each year of such research, not
p.000793:
p.000793:
p.000793:
p.000793:
p.000793: January 30, 2020
p.000793: 55 The font/style of the section heading shown above conforms with the style of the original section
p.000793: heading for section 487B in all small caps centered heading. See typeface for the amend- ment made by section
...

p.000793:
p.000793: more than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) contraception or infertility research;
p.000793: (ii) pediatric research, including pediatric pharma- cological research;
p.000793: (iii) minority health disparities research;
p.000793: (iv) clinical research; and
p.000793: (v) clinical research conducted by appropriately qualified health professional who are from disadvan- taged
p.000793: backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
p.000793: elimi- nate one or more subcategories provided for in paragraph (1) due to changes in workforce or
p.000793: scientific needs related to bio- medical research. The Director may establish other sub- category
p.000793: areas based on workforce and scientific priorities if the total number of subcategories does not exceed the
p.000793: number of subcategories listed in paragraph (1).
p.000793: (c) LIMITATION.—The Director of the National Institutes of Health may not enter into a contract with a
p.000793: health professional pursuant to subsection (a) unless such professional has a substan- tial amount of education
p.000793: loans relative to income (as determined pursuant to guidelines issued by the Director).
p.000793: (d) APPLICABILITY OF CERTAIN PROVISIONS REGARDING OBLI- GATED SERVICE.—The provisions of sections 338B,
p.000793: 338C, and 338E shall, except as inconsistent with subsection (a) of this section, apply to the program
p.000793: established in subsection (a) to the same ex- tent and in the same manner as such provisions apply to the
p.000793: Na- tional Health Service Corps Loan Repayment Program established in subpart III of part D of title III.
p.000793: (e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for carrying out this section shall remain available until
p.000793: the expiration of the second fiscal year beginning after the fiscal year for which the amounts were made
p.000793: available.
p.000793: øSection 487C was repealed by section 2022(c)(2) of Public Law 114–255.¿
p.000793:
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p.000793: January 30, 2020
p.000793: UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY NATIONAL RESEARCH INSTITUTES
p.000793: SEC. 487D. ø288–4¿ (a) ESTABLISHMENT OF PROGRAM.—
p.000793: (1) IN GENERAL.—Subject to section 487(a)(1)(C), the Sec- retary, acting through the Director of NIH, may
p.000793: carry out a program of entering into contracts with individuals described in paragraph (2) under which—
p.000793: (A) the Director of NIH agrees to provide to the indi- viduals scholarships for pursuing, as
p.000793: undergraduates at accredited institutions of higher education, academic pro-
p.000793: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000793:
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p.000795: 795
p.000795: PUBLIC HEALTH SERVICE ACT
p.000795: Sec. 487D
p.000795:
p.000795: grams appropriate for careers in professions needed by the National Institutes of Health; and
p.000795: (B) the individuals agree to serve as employees of the National Institutes of Health, for the period described
p.000795: in subsection (c), in positions that are needed by the National Institutes of Health and for which the
p.000795: individuals are qualified.
p.000795: (2) INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.— The individuals referred to in paragraph (1) are
p.000795: individuals who—
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p.000795: January 30, 2020
p.000795: (A) are enrolled or accepted for enrollment as full-time undergraduates at accredited institutions of higher edu-
p.000795: cation; and
p.000795: (B) are from disadvantaged backgrounds.
p.000795: (b) FACILITATION OF INTEREST OF STUDENTS IN CAREERS AT NA- TIONAL INSTITUTES OF HEALTH.—In providing
...

p.000795: regard to the provisions of title 5, United States Code, relating to ap- pointment and compensation.
p.000795: (d) PROVISIONS REGARDING SCHOLARSHIP.—
p.000795: (1) APPROVAL OF ACADEMIC PROGRAM.—The Director of NIH may not provide a scholarship under subsection (a)
p.000795: for an academic year unless—
p.000795: (A) the individual applying for the scholarship has submitted to the Director a proposed academic program for
p.000795: the year and the Director has approved the program; and
p.000795: (B) the individual agrees that the program will not be altered without the approval of the Director.
p.000795: (2) ACADEMIC STANDING.—The Director of NIH may not provide a scholarship under subsection (a) for an
p.000795: academic year unless the individual applying for the scholarship agrees to maintain an acceptable level of
p.000795: academic standing, as deter- mined by the educational institution involved in accordance with regulations issued
p.000795: by the Secretary.
p.000795: (3) LIMITATION ON AMOUNT.—The Director of NIH may not provide a scholarship under subsection (a) for an
p.000795: academic year in an amount exceeding $20,000.
p.000795: (4) AUTHORIZED USES.—A scholarship provided under sub- section (a) may be expended only for tuition
p.000795: expenses, other reasonable educational expenses, and reasonable living ex- penses incurred in attending
p.000795: the school involved.
p.000795: (5) CONTRACT REGARDING DIRECT PAYMENTS TO INSTITU- TION.—In the case of an institution of higher
p.000795: education with respect to which a scholarship under subsection (a) is provided, the Director of NIH may enter into a
p.000795: contract with the institu- tion under which the amounts provided in the scholarship for tuition and other
p.000795: educational expenses are paid directly to the institution.
p.000795: (e) PENALTIES FOR BREACH OF SCHOLARSHIP CONTRACT.—The provisions of section 338E shall apply to the
p.000795: program established in subsection (a) to the same extent and in the same manner as such provisions apply
p.000795: to the National Health Service Corps Loan Repayment Program established in section 338B.
p.000795: (f) REQUIREMENT OF APPLICATION.—The Director of NIH may not provide a scholarship under subsection
p.000795: (a) unless an applica- tion for the scholarship is submitted to the Director and the appli- cation is in such form,
p.000795: is made in such manner, and contains such agreements, assurances, and information as the Director deter- mines
p.000795: to be necessary to carry out this section.
p.000795: (g) AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— Amounts appropriated for a fiscal year for
p.000795: scholarships under this section shall remain available until the expiration of the second fis- cal year beginning
p.000795: after the fiscal year for which the amounts were appropriated.
p.000795:
p.000795:
p.000795:
p.000795:
p.000795:
p.000795: January 30, 2020
p.000795:
p.000795: VISITING SCIENTIST AWARDS
p.000795: SEC. 488. ø288a¿ (a) The Secretary may make awards (here- after in this section referred to as
p.000795: ‘‘Visiting Scientist Awards’’) to
p.000795: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000795:
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p.000797: 797
p.000797: PUBLIC HEALTH SERVICE ACT
p.000797: Sec. 489
p.000797:
p.000797: outstanding scientists who agree to serve as visiting scientists at institutions of postsecondary education
p.000797: which have significant en- rollments of disadvantaged students. Visiting Scientist Awards shall be made
p.000797: by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of
p.000797: scientists from other institutions for the purpose of receiving guidance, ad- vice, and instruction with
p.000797: regard to research, teaching, and cur- riculum development in the biomedical and behavioral sciences and such
p.000797: other aspects of these sciences as the Secretary shall deem ap- propriate.
p.000797: (b) The amount of each Visiting Scientist Award shall include such sum as shall be commensurate with
p.000797: the salary or remunera- tion which the individual receiving the award would have been en- titled to receive from the
p.000797: institution with which the individual has, or had, a permanent or immediately prior affiliation. Eligibility for and
p.000797: terms of Visiting Scientist Awards shall be determined in ac- cordance with regulations the Secretary shall
p.000797: prescribe.
p.000797:
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p.000797: January 30, 2020
p.000797: STUDIES RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH PERSONNEL
p.000797: SEC. 489. ø288b¿ (a) The Secretary shall, in accordance with subsection (b), arrange for the conduct of
p.000797: a continuing study to—
...

p.000815: and emergency medi- cine, including—
p.000815: (1) the basic science of emergency medicine;
p.000815: (2) the model of service delivery and the components of such models that contribute to enhanced patient
p.000815: health out- comes;
p.000815: (3) the translation of basic scientific research into im- proved practice; and
p.000815: (4) the development of timely and efficient delivery of health services.
p.000815: (b) PEDIATRIC EMERGENCY MEDICAL RESEARCH.—The Secretary shall support Federal programs administered by the National
p.000815: Insti- tutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services
p.000815: Administration, the Centers for Disease Control and Prevention, and other agencies to coordinate and expand
p.000815: research in pediatric emergency medical care systems and pediatric emergency medicine, including—
p.000815: (1) an examination of the gaps and opportunities in pedi- atric emergency care research and a strategy
p.000815: for the optimal organization and funding of such research;
p.000815: (2) the role of pediatric emergency services as an inte- grated component of the overall health system;
p.000815: (3) system-wide pediatric emergency care planning, pre- paredness, coordination, and funding;
p.000815: (4) pediatric training in professional education; and
p.000815: (5) research in pediatric emergency care, specifically on the efficacy, safety, and health outcomes of
p.000815: medications used for infants, children, and adolescents in emergency care settings in order to improve patient
p.000815: safety.
p.000815: (c) IMPACT RESEARCH.—The Secretary shall support research to determine the estimated economic impact of, and
p.000815: savings that re- sult from, the implementation of coordinated emergency care sys- tems.
p.000815: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000815: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000815:
p.000815:
p.000815:
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p.000815: Sec. 498E PUBLIC HEALTH SERVICE ACT 816
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p.000815: of bio- logical, social, and other determinants of health that contribute to health disparities;
p.000815: (5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological
p.000815: material and as- sociated information collected or stored in connection with the Initiative; and
p.000815: (6) on the appropriate Internet website of the Department of Health and Human Services, identify any entities
p.000815: with ac- cess to such information and provide information with respect to the purpose of such access, a
p.000815: summary of the research project for which such access is granted, as applicable, and a description of
p.000815: the biological material and associated informa- tion to which the entity has access.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000817: 817
p.000817: PUBLIC HEALTH SERVICE ACT
p.000817: Sec. 499
p.000817:
p.000817: (e) REPORT.—Not later than 1 year after the date of enactment of the 21st Century Cures Act, the Secretary shall submit
p.000817: a report on the relevant data access policies and procedures to the Com- mittee on Health, Education,
p.000817: Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Rep- resentatives.
p.000817: Such report shall include steps the Secretary has taken to consult with experts or other heads of
p.000817: departments or agencies of the Federal Government in the development of such policies.
p.000817:
p.000817: PART I—FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH
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p.000817: January 30, 2020
p.000817: SEC. 499. ø290b¿ ESTABLISHMENT AND DUTIES OF FOUNDATION.
p.000817: (a) IN GENERAL.—The Secretary shall, acting through the Di- rector of NIH, establish a nonprofit corporation to
p.000817: be known as the Foundation for the National Institutes of Health (hereafter in this section referred to as the
p.000817: ‘‘Foundation’’). The Foundation shall not be an agency or instrumentality of the United States Government.
p.000817: (b) PURPOSE OF FOUNDATION.—The purpose of the Foundation shall be to support the National Institutes of Health
p.000817: in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with
p.000817: biomedical researchers from uni- versities, industry, and nonprofit organizations.
p.000817: (c) CERTAIN ACTIVITIES OF FOUNDATION.—
p.000817: (1) IN GENERAL.—In carrying out subsection (b), the Foun- dation may solicit and accept gifts, grants, and
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p.000817: Sec. 499 PUBLIC HEALTH SERVICE ACT 818
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p.000817: January 30, 2020
p.000817:
p.000817: National Institutes of Health or elsewhere, or opportu- nities for employees of the National Institutes
p.000817: of Health or other public health officials in the United States to serve in such capacities in other countries,
p.000817: or both;
p.000817: (ii) the conduct and support of studies, projects, and research, which may include stipends, travel and
p.000817: other support for personnel in collaboration with na- tional and international non-profit and for-profit orga-
p.000817: nizations;
p.000817: (iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include
p.000817: undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of
p.000817: accreditation of such courses by the Foundation at the State and national level for college or
p.000817: continuing education credits or for degrees;
p.000817: (iv) programs to support and encourage teachers and students of science at all levels of education and
p.000817: programs for the general public which promote the un- derstanding of science;
p.000817: (v) programs for writing, editing, printing, pub- lishing, and vending of books and other materials; and
p.000817: (vi) the conduct of other activities to carry out and support the purpose described in subsection (b).
p.000817: (E) The Cures Acceleration Network described in sec- tion 480.
p.000817: (2) FEES.—The Foundation may assess fees for the provi- sion of professional, administrative and
p.000817: management services by the Foundation in amounts determined reasonable and ap- propriate by the Executive
p.000817: Director.
p.000817: (3) AUTHORITY OF FOUNDATION.—The Foundation shall be the sole entity responsible for carrying out the
p.000817: activities de- scribed in this subsection.
p.000817: (d) BOARD OF DIRECTORS.—
p.000817: (1) COMPOSITION.—
p.000817: (A) The Foundation shall have a Board of Directors (hereafter referred to in this section as the ‘‘Board’’),
p.000817: which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed
p.000817: members of the Board shall be voting members.
p.000817: (B) The ex officio members of the Board shall be—
p.000817: (i) the Chairman and ranking minority member of the Subcommittee on Health and the Environment (Committee on
p.000817: Energy and Commerce) or their des- ignees, in the case of the House of Representatives;
p.000817: (ii) the Chairman and ranking minority member of the Committee on Labor and Human Resources or their
p.000817: designees, in the case of the Senate;
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p.000823: property, and the source and amount of all gifts or grants to the Foundation of money. Each such report
p.000823: shall include a specification of any restrictions on the purposes for which gifts or grants to the
p.000823: Foundation may be used.
p.000823: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000823: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000823: charge that shall not exceed the cost of providing the copy; and
p.000823: (ii) to the appropriate committees of Congress.
p.000823: (D) The Board shall annually hold a public meeting to summarize the activities of the Foundation and distribute
p.000823: written reports concerning such activities and the scientific results derived from such activities.
p.000823: (5) SERVICE OF FEDERAL EMPLOYEES.—Federal employees may serve on committees advisory to the Foundation
p.000823: and oth- erwise cooperate with and assist the Foundation in carrying out its function, so long as the
p.000823: employees do not direct or con- trol Foundation activities.
p.000823: (6) RELATIONSHIP WITH EXISTING ENTITIES.—The Founda- tion may, pursuant to appropriate agreements, merge with,
p.000823: ac- quire, or use the resources of existing nonprofit private cor- porations with missions similar to the
p.000823: purposes of the Founda- tion, such as the Foundation for Advanced Education in the Sciences.
p.000823: (7) INTELLECTUAL PROPERTY RIGHTS.—The Board shall adopt written standards with respect to the
p.000823: ownership of any intellectual property rights derived from the collaborative ef- forts of the Foundation prior
p.000823: to the commencement of such ef- forts.
p.000823: (8) NATIONAL INSTITUTES OF HEALTH AMENDMENTS OF 1990.—The activities conducted in support of the
p.000823: National Insti- tutes of Health Amendments of 1990 (Public Law 101–613), and the amendments made by such
p.000823: Act, shall not be nullified by the enactment of this section.
p.000823: (9) LIMITATION OF ACTIVITIES.—
p.000823: (A) IN GENERAL.—The Foundation shall exist solely as an entity to work in collaboration with the research pro-
p.000823: grams of the National Institutes of Health. The Founda- tion may not undertake activities (such as the
p.000823: operation of independent laboratories or competing for Federal research funds) that are independent of those of the
p.000823: National Insti- tutes of Health research programs.
p.000823: (B) GIFTS, GRANTS, AND OTHER DONATIONS.—
p.000823: (i) IN GENERAL.—Gifts, grants, and other dona- tions to the Foundation may be designated for pedi- atric
p.000823: research and studies on drugs, and funds so des- ignated shall be used solely for grants for research and studies under
p.000823: subsection (c)(1)(C).
p.000823: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000827: outcomes;
p.000827: (D) the extent to which the grantee must collect and report on required performance measures; and
p.000827: (E) the extent to which the grantee is proposing to use evidence-based practices; and
p.000827: (25) advance, through existing programs, the use of per- formance metrics, including those based on the
p.000827: recommenda- tions on performance metrics from the Assistant Secretary for Planning and Evaluation under section
p.000827: 6021(d) of the Helping Families in Mental Health Crisis Reform Act of 2016.
p.000827: (e) ASSOCIATE ADMINISTRATOR FOR ALCOHOL PREVENTION AND
p.000827: TREATMENT POLICY.—
p.000827: (1) IN GENERAL.—There may be in the Administration an Associate Administrator for Alcohol Prevention and
p.000827: Treatment Policy to whom the Assistant Secretary may delegate the func- tions of promoting, monitoring, and
p.000827: evaluating service pro- grams for the prevention and treatment of alcoholism and alco- hol abuse within the
p.000827: Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center for Mental Health
p.000827: Services, and coordinating such programs among the Centers, and among the Centers and other public
p.000827: and private entities. The Associate Administrator also may en- sure that alcohol prevention, education, and
p.000827: policy strategies are integrated into all programs of the Centers that address substance abuse prevention,
p.000827: education, and policy, and that the Center for Substance Abuse Prevention addresses the Healthy
p.000827: People 2010 goals and the National Dietary Guide-
p.000827: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: 829
p.000829: PUBLIC HEALTH SERVICE ACT
p.000829: Sec. 501
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p.000829: January 30, 2020
p.000829: lines of the Department of Health and Human Services and the Department of Agriculture related to alcohol
p.000829: consumption.
p.000829: (2) PLAN.—
p.000829: (A) The Assistant Secretary, acting through the Asso- ciate Administrator for Alcohol Prevention and
p.000829: Treatment Policy, shall develop, and periodically review and as appro- priate revise, a plan for programs and policies
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p.000833: and activities are assigned.
p.000833: (l) STRATEGIC PLAN.—
p.000833: (1) IN GENERAL.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant Secretary shall
p.000833: develop and carry out a strategic plan in accordance with this sub- section for the planning and operation of
p.000833: activities carried out by the Administration, including evidence-based programs.
p.000833: (2) COORDINATION.—In developing and carrying out the strategic plan under this subsection, the Assistant
p.000833: Secretary shall take into consideration the findings and recommenda- tions of the Assistant Secretary for
p.000833: Planning and Evaluation under section 6021(d) of the Helping Families in Mental Health Crisis
p.000833: Reform Act of 2016 and the report of the Inter- departmental Serious Mental Illness Coordinating
p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000833: January 30, 2020
p.000833: (A) submit the strategic plan developed under para- graph (1) to the Committee on Energy and Commerce and the
p.000833: Committee on Appropriations of the House of Rep- resentatives and the Committee on Health,
p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: disturbance; and
p.000833: (ii) a strategy to improve the recruitment, train- ing, and retention of a workforce for the treatment
p.000833: of individuals with mental or substance use disorders, or co-occurring disorders;
p.000833: (E) identify opportunities to improve collaboration with States, local governments, communities, and
p.000833: Indian tribes and tribal organizations (as such terms are defined in section 4 of the Indian
p.000833: Self-Determination and Edu- cation Assistance Act); and
p.000833: (F) specify a strategy to disseminate evidence-based and promising best practices related to prevention,
p.000833: diag- nosis, early intervention, treatment, and recovery services related to mental illness, particularly for
p.000833: adults with a se- rious mental illness and children with a serious emotional disturbance, and for individuals with
p.000833: a substance use dis- order.
p.000833: (m) BIENNIAL REPORT CONCERNING ACTIVITIES AND PROGRESS.—Not later than September 30, 2020,
p.000833: and every 2 years thereafter, the Assistant Secretary shall prepare and submit to the Committee on Energy and Commerce
p.000833: and the Committee on Appro- priations of the House of Representatives and the Committee on Health, Education,
p.000833: Labor, and Pensions and the Committee on Ap- propriations of the Senate, and post on the Internet website of the
p.000833: Administration, a report containing at a minimum—
p.000833: (1) a review of activities conducted or supported by the Ad- ministration, including progress toward strategic
p.000833: priorities, goals, and objectives identified in the strategic plan developed under subsection (l);
p.000833: (2) an assessment of programs and activities carried out by the Assistant Secretary, including the extent to
p.000833: which pro- grams and activities under this title and part B of title XIX meet identified goals and
p.000833: performance measures developed for the respective programs and activities;
p.000833: (3) a description of the progress made in addressing gaps in mental and substance use disorders
p.000833: prevention, treatment, and recovery services and improving outcomes by the Adminis-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: PUBLIC HEALTH SERVICE ACT
p.000835: Sec. 501
p.000835:
p.000835: tration, including with respect to serious mental illnesses, seri- ous emotional disturbances, and co-occurring
p.000835: disorders;
p.000835: (4) a description of the manner in which the Administra- tion coordinates and partners with other Federal
p.000835: agencies and departments related to mental and substance use disorders, in- cluding activities related to—
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p.000837: to adults with a serious mental illness, children with a serious emotional disturbance, or
p.000837: individuals in a mental health crisis; and
p.000837: (B) may include clinical protocols and practices that address the needs of individuals with early serious mental
p.000837: illness.
p.000837: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000837: Sec. 501A PUBLIC HEALTH SERVICE ACT 838
p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
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p.000845: Native Alaskans who reside on reservations and tribal lands’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: 847
p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
p.000847: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000847: submit, in the ap- plication for such grant, a plan for the evaluation of any project un- dertaken with funds provided
p.000847: under this section. Such entity shall provide the Secretary with periodic evaluations of the progress of such
p.000847: project and such evaluation at the completion of such project as the Secretary determines to be appropriate.
p.000847: The final evaluation submitted by such entity shall include a recommendation as to whether such project shall
p.000847: continue.
p.000847: (f) REPORT.—Not later than 3 years after the date of the enact- ment of this section and annually thereafter,
p.000847: the Secretary shall prepare and submit, to the Committee on Health, Education, Labor, and Pensions of
p.000847: the Senate, a report describing the services provided pursuant to this section.
p.000847: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000847: $15,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 and 2003.
p.000847: PART B—CENTERS AND PROGRAMS
p.000847: Subpart 1—Center for Substance Abuse Treatment
p.000847: CENTER FOR SUBSTANCE ABUSE TREATMENT 6
p.000847: SEC. 507. ø290bb¿ (a) ESTABLISHMENT.—There is established in the Administration a Center for Substance
p.000847: Abuse Treatment (hereafter in this section referred to as the ‘‘Center’’). The Center shall be headed by a
p.000847: Director (hereafter in this section referred to as the ‘‘Director’’) appointed by the Secretary from among
p.000847: individ- uals with extensive experience or academic qualifications in the treatment of substance use
p.000847: disorders or in the evaluation of sub- stance use disorder treatment systems.
p.000847: (b) DUTIES.—The Director of the Center shall—
p.000847: (1) administer the substance use disorder treatment block grant program authorized in section 1921;
p.000847: (2) ensure that emphasis is placed on children and adoles- cents in the development of treatment programs;
p.000847: (3) collaborate with the Attorney General to develop pro- grams to provide substance use disorder
p.000847: treatment services to individuals who have had contact with the Justice system, es- pecially adolescents;
p.000847: (4) collaborate with the Director of the Center for Sub- stance Abuse Prevention in order to provide
p.000847: outreach services to identify individuals in need of treatment services, with em-
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p.000847: January 30, 2020
p.000847: 6 Section 4 of Public Law 108–358 (118 Stat. 1664) authorizes the Secretary of Health and Human Services
p.000847: to ‘‘award grants to public and nonprofit private entities to enable such entities to carry out science-based education
p.000847: programs in elementary and secondary schools to highlight the harmful effects of anabolic steroids’’. Subsection
p.000847: (d) of such section provides that there is authorized to be appropriated to carry out the section
p.000847: $15,000,000 for each of the fiscal years 2005 through 2010.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: Sec. 507 PUBLIC HEALTH SERVICE ACT 848
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p.000847: phasis on the provision of such services to pregnant and postpartum women and their infants and to
p.000847: individuals who il- licitly use drugs intravenously;
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p.000847: (8) sponsor regional workshops on improving the quality and availability of treatment services;
p.000847: (9) provide technical assistance to public and nonprofit pri- vate entities that provide treatment services,
p.000847: including tech- nical assistance with respect to the process of submitting to the Director applications for any
p.000847: program of grants or contracts;
p.000847: (10) carry out activities to educate individuals on the need for establishing treatment facilities within their
p.000847: communities;
p.000847: (11) encourage public and private entities that provide health insurance to provide benefits for
p.000847: outpatient treatment services and other nonhospital-based treatment services;
p.000847: (12) evaluate treatment programs to determine the quality and appropriateness of various forms of treatment, which
p.000847: shall be carried out through grants, contracts, or cooperative agree- ments provided to public or nonprofit
p.000847: private entities;
p.000847: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000847: of grantees after such grants are awarded;
p.000847: (14) work with States, providers, and individuals in recov- ery, and their families, to promote the expansion
p.000847: of recovery support services and systems of care oriented toward recovery;
p.000847: (15) in cooperation with the Secretary, implement and dis- seminate, as appropriate, the recommendations in the
p.000847: report entitled ‘‘Protecting Our Infants Act: Final Strategy’’ issued by the Department of Health and Human
p.000847: Services in 2017; and
p.000847: (16) in cooperation with relevant stakeholders, and through public-private partnerships,
p.000847: encourage education about substance use disorders for pregnant women and health care providers who treat pregnant
p.000847: women and babies.
p.000847: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000847: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000847: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: 849
p.000849: PUBLIC HEALTH SERVICE ACT
p.000849: Sec. 508
p.000849:
p.000849: RESIDENTIAL TREATMENT PROGRAMS FOR PREGNANT AND POSTPARTUM WOMEN
p.000849: SEC. 508. ø290bb–1¿ (a) IN GENERAL.—The Director of the Center for Substance Abuse Treatment (referred to
p.000849: in this section as the ‘‘Director’’) shall provide awards of grants, including the grants under subsection
p.000849: (r), cooperative agreements or contracts to public and nonprofit private entities for the purpose of providing to
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p.000851: Government, may not be included in determining the amount of such non-Federal contributions.
p.000851: (g) OUTREACH.—A funding agreement for an award under sub- section (a) for an applicant is that the applicant
p.000851: will provide out- reach services in the community involved to identify women who have a substance use
p.000851: disorder and to encourage the women to un- dergo treatment for such disorder.
p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
p.000851: (3) will not be imposed on any such woman with an income of less than 185 percent of the official poverty
p.000851: line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000851: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000851: (k) REPORTS TO DIRECTOR.—A funding agreement for an award under subsection (a) is that the applicant involved
p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
p.000851: (3) providing such other information as the Director deter- mines to be appropriate.
p.000851: (l) REQUIREMENT OF APPLICATION.—The Director may make an award under subsection (a) only if an application for
p.000851: the award is submitted to the Director containing such agreements, and the ap- plication is in such form, is
...

p.000855: for—
p.000855: (1) knowledge development and application projects for treatment and rehabilitation and the conduct or
p.000855: support of evaluations of such projects;
p.000855: (2) training and technical assistance; and
p.000855: (3) targeted capacity response programs that permit States, local governments, communities, and Indian
p.000855: tribes and tribal organizations (as the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in
p.000855: section 4 of the Indian Self-Deter-
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000855: Sec. 509 PUBLIC HEALTH SERVICE ACT 856
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p.000855:
p.000855: mination and Education Assistance Act) to focus on emerging trends in substance abuse and co-occurrence
p.000855: of substance use disorders with mental illness or other conditions.
p.000855: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000855: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000855: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000855: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000855: public or nonprofit private entities.
p.000855: (b) PRIORITY SUBSTANCE ABUSE TREATMENT NEEDS.—
p.000855: (1) IN GENERAL.—Priority substance use disorder treat- ment needs of regional and national significance shall be
p.000855: deter- mined by the Secretary after consultation with States and other interested groups. The Secretary
p.000855: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000855: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000855: con- sideration to promoting the integration of substance use dis- order treatment services into primary health
p.000855: care systems.
p.000855: (c) REQUIREMENTS.—
p.000855: (1) IN GENERAL.—Recipients of grants, contracts, or cooper- ative agreements under this section shall comply with
p.000855: informa- tion and application requirements determined appropriate by the Secretary.
p.000855: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000855: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000855: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000855: entities that apply for grants, contracts, or cooperative agreements under that project provide non-Federal
p.000855: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000855: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
p.000855: matching funds may be provided directly or through donations from public or private entities and may be in
p.000855: cash or in kind, fairly evaluated, including plant, equipment, or services.
p.000855: (4) MAINTENANCE OF EFFORT.—With respect to activities for which a grant, contract, or cooperative agreement
p.000855: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000855: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.000855: less than the level of such expenditures main- tained by the entity for the fiscal year preceding the fiscal year for
p.000855: which the entity receives such a grant, contract, or coopera- tive agreement.
p.000855: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000855: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000855: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: 857
p.000857: PUBLIC HEALTH SERVICE ACT
p.000857: Sec. 513
p.000857:
p.000857: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000857: programs to dissemi- nate and apply the findings of the knowledge development and ap- plication, training and technical
p.000857: assistance programs, and targeted capacity response programs under this section to the general pub- lic, to
p.000857: health professionals and other interested groups. The Sec- retary shall make every effort to provide linkages
p.000857: between the find- ings of supported projects and State agencies responsible for car- rying out substance
p.000857: use disorder prevention and treatment pro- grams.
p.000857: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000857: $333,806,000 for each of fiscal years 2018 through 2022.
p.000857: ACTION BY NATIONAL INSTITUTE ON DRUG ABUSE AND STATES CONCERNING MILITARY FACILITIES
p.000857: SEC. 513. 7 ø290bb–6¿ (a) CENTER FOR SUBSTANCE ABUSE
p.000857: TREATMENT.—The Director of the Center for Substance Abuse Treatment shall—
p.000857: (1) coordinate with the agencies represented on the Com- mission on Alternative Utilization of Military
p.000857: Facilities the uti- lization of military facilities or parts thereof, as identified by such Commission,
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p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: 861
p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: (7) in cooperation with the Director of the Centers for Dis- ease Control and Prevention, develop and disseminate
p.000861: edu- cational materials to increase awareness for individuals at greatest risk for substance use disorders to
p.000861: prevent the trans- mission of communicable diseases, such as HIV, hepatitis, tu- berculosis, and other
p.000861: communicable diseases;
p.000861: (8) conduct training, technical assistance, data collection, and evaluation activities of programs supported
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p.000861: Sec. 516 PUBLIC HEALTH SERVICE ACT 862
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p.000861: (2) training and technical assistance; and
p.000861: (3) targeted capacity response programs, including such programs that focus on emerging drug abuse issues.
p.000861: The Secretary may carry out the activities described in this section directly or through grants, contracts, or
p.000861: cooperative agreements with States, political subdivisions of States, Indian tribes or tribal organizations
p.000861: (as such terms are defined in section 4 of the Indian Self-Determination and Education Assistance Act), health
p.000861: facilities, or programs operated by or in accordance with a contract or grant with the Indian Health Service, or other
p.000861: public or nonprofit private entities.
p.000861: (b) PRIORITY SUBSTANCE ABUSE PREVENTION NEEDS.—
p.000861: (1) IN GENERAL.—Priority substance use disorder preven- tion needs of regional and national significance shall be
p.000861: deter- mined by the Secretary in consultation with the States and other interested groups. The Secretary
p.000861: shall meet with the States and interested groups on an annual basis to discuss pro- gram priorities.
p.000861: (2) SPECIAL CONSIDERATION.—In developing program prior- ities under paragraph (1), the Secretary shall give special
p.000861: con- sideration to—
p.000861: (A) applying the most promising strategies and re- search-based primary prevention approaches;
p.000861: (B) promoting the integration of substance use dis- order prevention information and activities into
p.000861: primary health care systems; and
p.000861: (C) substance use disorder prevention among high-risk groups.
p.000861: (c) REQUIREMENTS.—
p.000861: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000861: infor- mation and application requirements determined appropriate by the Secretary.
p.000861: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
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p.000861: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000861: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.000861: less than the level of such expenditures main- tained by the entity for the fiscal year preceding the fiscal year
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000863: PUBLIC HEALTH SERVICE ACT
p.000863: Sec. 519B
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p.000863: January 30, 2020
p.000863: for which the entity receives such a grant, contract, or coopera- tive agreement.
p.000863: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000863: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000863: (e) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000863: programs to dissemi- nate the findings of the knowledge development and application, training and technical
p.000863: assistance programs, and targeted capacity response programs under this section to the general public and
p.000863: to health professionals. The Secretary shall make every effort to pro- vide linkages between the findings of supported
p.000863: projects and State agencies responsible for carrying out substance use disorder pre- vention and treatment
p.000863: programs.
p.000863: (f) AUTHORIZATION OF APPROPRIATION.—There are authorized to be appropriated to carry out this section,
p.000863: $211,148,000 for each of fiscal years 2018 through 2022.
p.000863: øSection 517 was repealed by section 9017 of Public Law 114–
p.000863: 255. Section 518 was repealed by section 3202(b) of Public Law 106–310 (114 Stat. 1210). Section 519A
p.000863: was repealed by section 9017 of Public Law 114–255.¿
p.000863: SEC. 519B. ø290bb–25b¿ PROGRAMS TO REDUCE UNDERAGE DRINKING.
p.000863: (a) DEFINITIONS.—For purposes of this section:
p.000863: (1) The term ‘‘alcohol beverage industry’’ means the brew- ers, vintners, distillers, importers, distributors, and
p.000863: retail or online outlets that sell or serve beer, wine, and distilled spirits.
p.000863: (2) The term ‘‘school-based prevention’’ means programs, which are institutionalized, and run by
p.000863: staff members or school-designated persons or organizations in any grade of school, kindergarten through
p.000863: 12th grade.
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p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
p.000863: (B) OTHER AGENCIES.—The officials referred to in paragraph (1) are the Secretary of Education, the Attorney
p.000863: General, the Secretary of Transportation, the Secretary of the Treasury, the Secretary of Defense, the
p.000863: Surgeon Gen- eral, the Director of the Centers for Disease Control and Prevention, the Director of the
p.000863: National Institute on Alco- hol Abuse and Alcoholism, the Assistant Secretary for Mental Health and Substance
p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
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p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
p.000867: (dd) underage drinking prevention pro- grams that target youth within the juvenile justice and child
p.000867: welfare systems; and
p.000867: (ee) other State efforts or programs as deemed appropriate.
p.000867: (3) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000867: $1,000,000 for each of the fiscal years 2018 through 2022.
p.000867: (d) NATIONAL MEDIA CAMPAIGN TO PREVENT UNDERAGE DRINK-
p.000867: ING.—
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p.000867: January 30, 2020
p.000867: (1) SCOPE OF THE CAMPAIGN.—The Secretary shall continue
p.000867: to fund and oversee the production, broadcasting, and evalua- tion of the national adult-oriented media
p.000867: public service cam- paign if the Secretary determines that such campaign is effec- tive in achieving the media
p.000867: campaign’s measurable objectives.
p.000867: (2) REPORT.—The Secretary shall provide a report to the Congress annually detailing the production,
p.000867: broadcasting, and evaluation of the campaign referred to in paragraph (1), and to detail in the report the
p.000867: effectiveness of the campaign in reduc- ing underage drinking, the need for and likely effectiveness of an expanded
p.000867: adult-oriented media campaign, and the feasi- bility and the likely effectiveness of a national
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p.000869: under this paragraph shall not exceed $50,000 per year and may not exceed four years.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: not supplant, Federal and non-Federal funds available for carrying out the activities described in this
p.000869: paragraph.
p.000869: (F) EVALUATION.—Grants under this paragraph shall be subject to the same evaluation requirements and proce- dures
p.000869: as the evaluation requirements and procedures im- posed on recipients of drug free community grants.
p.000869: (G) DEFINITIONS.—For purposes of this paragraph, the term ‘‘eligible entity’’ means an organization that is
p.000869: cur- rently receiving or has received grant funds under the Drug-Free Communities Act of 1997 (21 U.S.C.
p.000869: 1521 et seq.).
p.000869: (H) ADMINISTRATIVE EXPENSES.—Not more than 6 per- cent of a grant under this paragraph may be expended for
p.000869: administrative expenses.
p.000869: (I) AUTHORIZATION OF APPROPRIATIONS.—There are au- thorized to be appropriated to carry out this paragraph
p.000869: $5,000,000 for each of the fiscal years 2018 through 2022.
p.000869: (2) GRANTS DIRECTED AT PREVENTING AND REDUCING ALCO- HOL ABUSE AT INSTITUTIONS OF HIGHER EDUCATION.—
p.000869: (A) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to eligible entities to enable the entities to
p.000869: prevent and reduce the rate of underage alcohol consump- tion including binge drinking among students at
p.000869: institu- tions of higher education.
p.000869: (B) APPLICATIONS.—An eligible entity that desires to receive a grant under this paragraph shall submit an
p.000869: ap- plication to the Secretary at such time, in such manner, and accompanied by such information as the
p.000869: Secretary may require. Each application shall include—
p.000869: (i) a description of how the eligible entity will work to enhance an existing, or where none exists to
p.000869: build a, statewide coalition;
p.000869: (ii) a description of how the eligible entity will tar- get underage students in the State;
p.000869: (iii) a description of how the eligible entity intends to ensure that the statewide coalition is actually im-
p.000869: plementing the purpose of this section and moving to- ward indicators described in subparagraph (D);
p.000869: (iv) a list of the members of the statewide coali- tion or interested parties involved in the work of
p.000869: the eligible entity;
p.000869: (v) a description of how the eligible entity intends to work with State agencies on substance abuse pre-
p.000869: vention and education;
p.000869: (vi) the anticipated impact of funds provided under this paragraph in preventing and reducing the
p.000869: rates of underage alcohol use;
p.000869: (vii) outreach strategies, including ways in which the eligible entity proposes to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000869: Sec. 519B PUBLIC HEALTH SERVICE ACT 870
p.000869:
p.000869: (I) reach out to students and community stakeholders;
p.000869: (II) promote the purpose of this paragraph;
p.000869: (III) address the range of needs of the stu- dents and the surrounding communities; and
p.000869: (IV) address community norms for underage students regarding alcohol use; and
p.000869: (viii) such additional information as required by the Secretary.
p.000869: (C) USES OF FUNDS.—Each eligible entity that receives a grant under this paragraph shall use the grant funds to
p.000869: carry out the activities described in such entity’s applica- tion submitted pursuant to subparagraph (B).
p.000869: (D) ACCOUNTABILITY.—On the date on which the Sec- retary first publishes a notice in the Federal Register solic-
p.000869: iting applications for grants under this paragraph, the Sec- retary shall include in the notice achievement
p.000869: indicators for the program authorized under this paragraph. The achievement indicators shall be designed—
p.000869: (i) to measure the impact that the statewide coali- tions assisted under this paragraph are having on the institutions
p.000869: of higher education and the surrounding communities, including changes in the number of inci- dents of any kind in
p.000869: which students have abused alco- hol or consumed alcohol while under the age of 21 (in- cluding violations, physical
p.000869: assaults, sexual assaults, reports of intimidation, disruptions of school functions, disruptions of student studies,
p.000869: mental health referrals, illnesses, or deaths);
p.000869: (ii) to measure the quality and accessibility of the programs or information offered by the eligible entity; and
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p.000869: January 30, 2020
p.000869: (iii) to provide such other measures of program impact as the Secretary determines appropriate.
p.000869: (E) SUPPLEMENT NOT SUPPLANT.—Grant funds pro- vided under this paragraph shall be used to supplement,
p.000869: and not supplant, Federal and non-Federal funds available for carrying out the activities described in this paragraph.
p.000869: (F) DEFINITIONS.—For purposes of this paragraph:
p.000869: (i) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, institution of higher education, or non- profit
p.000869: entity.
p.000869: (ii) INSTITUTION OF HIGHER EDUCATION.—The term ‘‘institution of higher education’’ has the meaning given
p.000869: the term in section 101(a) of the Higher Edu- cation Act of 1965 (20 U.S.C. 1001(a)).
p.000869: (iii) SECRETARY.—The term ‘‘Secretary’’ means the Secretary of Education.
p.000869: (iv) STATE.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and the Common- wealth of
p.000869: Puerto Rico.
p.000869: (v) STATEWIDE COALITION.—The term ‘‘statewide coalition’’ means a coalition that—
p.000869: (I) includes, but is not limited to—
p.000869: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000871: 871
p.000871: PUBLIC HEALTH SERVICE ACT
p.000871: Sec. 519B
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p.000871: January 30, 2020
p.000871: (aa) institutions of higher education with- in a State; and
p.000871: (bb) a nonprofit group, a community un- derage drinking prevention coalition, or an- other substance abuse
p.000871: prevention group with- in a State; and
p.000871: (II) works toward lowering the alcohol abuse rate by targeting underage students at institu- tions of
p.000871: higher education throughout the State and in the surrounding communities.
p.000871: (vi) SURROUNDING COMMUNITY.—The term ‘‘sur- rounding community’’ means the community—
p.000871: (I) that surrounds an institution of higher education participating in a statewide coalition;
p.000871: (II) where the students from the institution of higher education take part in the community; and
p.000871: (III) where students from the institution of higher education live in off-campus housing.
p.000871: (G) ADMINISTRATIVE EXPENSES.—Not more than 5 per- cent of a grant under this paragraph may be expended for
p.000871: administrative expenses.
p.000871: (H) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this
p.000871: paragraph
p.000871: $5,000,000 for fiscal year 2007, and $5,000,000 for each of the fiscal years 2008 through 2010.
p.000871: (f) ADDITIONAL RESEARCH.—
p.000871: (1) ADDITIONAL RESEARCH ON UNDERAGE DRINKING.—
p.000871: (A) IN GENERAL.—The Secretary shall, subject to the availability of appropriations, collect data, and
p.000871: conduct or support research that is not duplicative of research cur- rently being conducted or supported by
p.000871: the Department of Health and Human Services, on underage drinking, with respect to the following:
p.000871: (i) Comprehensive community-based programs or strategies and statewide systems to prevent and re- duce
p.000871: underage drinking, across the underage years from early childhood to age 21, including programs funded and
p.000871: implemented by government entities, pub- lic health interest groups and foundations, and alcohol beverage companies and
p.000871: trade associations.
p.000871: (ii) Annually obtain and report more precise infor- mation than is currently collected on the scope of the
p.000871: underage drinking problem and patterns of underage alcohol consumption, including improved knowledge
p.000871: about the problem and progress in preventing, reduc- ing and treating underage drinking; as well as
p.000871: infor- mation on the rate of exposure of youth to advertising and other media messages encouraging and discour-
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p.000875: 875
p.000875: PUBLIC HEALTH SERVICE ACT
p.000875: Sec. 520
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p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
p.000875: out the provisions of the Protection and Advocacy of Mentally Ill Individuals Act;
...

p.000875: (17) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000875: of grantees after such grants are awarded.
p.000875: (c) GRANTS AND CONTRACTS.—In carrying out the duties estab- lished in subsection (b), the Director may make grants to
p.000875: and enter into contracts and cooperative agreements with public and non- profit private entities.
p.000875: SEC. 520A. ø290bb–32¿ PRIORITY MENTAL HEALTH NEEDS OF RE- GIONAL AND NATIONAL SIGNIFICANCE.
p.000875: (a) PROJECTS.—The Secretary shall address priority mental health needs of regional and national
p.000875: significance (as determined under subsection (b)) through the provision of or through assist- ance for—
p.000875: (1) knowledge development and application projects for prevention, treatment, and rehabilitation, and the
p.000875: conduct or support of evaluations of such projects;
p.000875: (2) training and technical assistance programs;
p.000875: (3) targeted capacity response programs; and
p.000875: (4) systems change grants including statewide family net- work grants and client-oriented and consumer run
p.000875: self-help ac- tivities, which may include technical assistance centers.
p.000875: The Secretary may carry out the activities described in this sub- section directly or through grants,
p.000875: contracts, or cooperative agree- ments with States, political subdivisions of States, Indian tribes or tribal
p.000875: organizations (as such terms are defined in section 4 of the Indian Self-Determination and Education
p.000875: Assistance Act), health facilities, or programs operated by or in accordance with a contract or grant with the Indian
p.000875: Health Service, or, other public or private nonprofit entities.
p.000875: (b) PRIORITY MENTAL HEALTH NEEDS.—
p.000875: (1) DETERMINATION OF NEEDS.—Priority mental health needs of regional and national significance shall be
p.000875: determined by the Secretary in consultation with States and other inter- ested groups. The Secretary shall
p.000875: meet with the States and in- terested groups on an annual basis to discuss program prior- ities.
p.000875: (2) SPECIAL CONSIDERATION.—In developing program prior- ities described in paragraph (1), the Secretary shall
p.000875: give spe- cial consideration to promoting the integration of mental health services into primary health
p.000875: care systems.
p.000875: (c) REQUIREMENTS.—
p.000875: (1) IN GENERAL.—Recipients of grants, contracts, and coop- erative agreements under this section shall comply with
p.000875: infor- mation and application requirements determined appropriate by the Secretary.
p.000875: (2) DURATION OF AWARD.—With respect to a grant, con- tract, or cooperative agreement awarded under this
p.000875: section, the period during which payments under such award are made to the recipient may not exceed 5 years.
p.000875: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000877: PUBLIC HEALTH SERVICE ACT
p.000877: Sec. 520A
p.000877:
p.000877: (3) MATCHING FUNDS.—The Secretary may, for projects carried out under subsection (a), require that
p.000877: entities that apply for grants, contracts, or cooperative agreements under this section provide non-Federal
p.000877: matching funds, as deter- mined appropriate by the Secretary, to ensure the institutional commitment of the
p.000877: entity to the projects funded under the grant, contract, or cooperative agreement. Such non-Federal
p.000877: matching funds may be provided directly or through donations from public or private entities and may be in
p.000877: cash or in kind, fairly evaluated, including plant, equipment, or services.
p.000877: (4) MAINTENANCE OF EFFORT.—With respect to activities for which a grant, contract or cooperative agreement
p.000877: is award- ed under this section, the Secretary may require that recipi- ents for specific projects under
p.000877: subsection (a) agree to maintain expenditures of non-Federal amounts for such activities at a level that is not
p.000877: less than the level of such expenditures main- tained by the entity for the fiscal year preceding the fiscal year for
p.000877: which the entity receives such a grant, contract, or coopera- tive agreement.
p.000877: (d) EVALUATION.—The Secretary shall evaluate each project carried out under subsection (a)(1) and shall
p.000877: disseminate the find- ings with respect to each such evaluation to appropriate public and private entities.
p.000877: (e) INFORMATION AND EDUCATION.—
p.000877: (1) IN GENERAL.—The Secretary shall establish information and education programs to disseminate and apply the findings
p.000877: of the knowledge development and application, training, and technical assistance programs, and targeted
p.000877: capacity response programs, under this section to the general public, to health care professionals, and to
p.000877: interested groups. The Secretary shall make every effort to provide linkages between the find- ings of
p.000877: supported projects and State agencies responsible for carrying out mental health services.
p.000877: (2) RURAL AND UNDERSERVED AREAS.—In disseminating in- formation on evidence-based practices in the provision of
p.000877: chil- dren’s mental health services under this subsection, the Sec- retary shall ensure that such
p.000877: information is distributed to rural and medically underserved areas.
p.000877: (3) GERIATRIC MENTAL DISORDERS.—The Secretary shall, as appropriate, provide technical assistance to grantees regarding
p.000877: evidence-based practices for the prevention and treatment of geriatric mental disorders and co-occurring
p.000877: mental health and substance use disorders among geriatric populations, as well as disseminate information about such
p.000877: evidence-based practices to States and nongrantees throughout the United States.
p.000877: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.000877: $394,550,000 for each of fiscal years 2018 through 2022.
p.000877: øSection 520B was repealed by section 9017 of Public Law 114–255.¿
p.000877:
p.000877: January 30, 2020 As Amended Through P.L. 116-94,
p.000877: Enacted December 20, 2019
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p.000877: Sec. 520C PUBLIC HEALTH SERVICE ACT 878
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p.000877: January 30, 2020
p.000877:
p.000877: SEC. 520C. ø290bb–34¿ SUICIDE PREVENTION TECHNICAL ASSISTANCE CENTER.
p.000877: (a) PROGRAM AUTHORIZED.—The Secretary, acting through the Assistant Secretary, shall establish a research,
p.000877: training, and tech- nical assistance resource center to provide appropriate information, training, and technical
p.000877: assistance to States, political subdivisions of States, federally recognized Indian tribes, tribal organizations,
p.000877: in- stitutions of higher education, public organizations, or private non- profit organizations regarding the
p.000877: prevention of suicide among all ages, particularly among groups that are at a high risk for suicide.
p.000877: (b) RESPONSIBILITIES OF THE CENTER.—The center established under subsection (a) shall conduct activities for
p.000877: the purpose of—
p.000877: (1) developing and continuing statewide or tribal suicide early intervention and prevention strategies for
p.000877: all ages, par- ticularly among groups that are at a high risk for suicide;
p.000877: (2) ensuring the surveillance of suicide early intervention and prevention strategies for all ages,
p.000877: particularly among groups that are at a high risk for suicide;
p.000877: (3) studying the costs and effectiveness of statewide and tribalsuicide early intervention and prevention
p.000877: strategies in order to provide information concerning relevant issues of im- portance to State, tribal, and
p.000877: national policymakers;
p.000877: (4) further identifying and understanding causes and asso- ciated risk factors for suicide;
p.000877: (5) analyzing the efficacy of new and existing suicide early intervention and prevention techniques and technology;
p.000877: (6) ensuring the surveillance of suicidal behaviors and nonfatal suicidal attempts;
p.000877: (7) studying the effectiveness of State-sponsored statewide and tribal suicide early intervention and prevention
p.000877: strategies on the overall wellness and health promotion strategies related to suicide attempts;
p.000877: (8) promoting the sharing of data regarding suicide with Federal agencies involved with suicide early
p.000877: intervention and prevention, and State-sponsored statewide or tribal suicide early intervention and prevention
p.000877: strategies for the purpose of identifying previously unknown mental health causes and asso- ciated risk factors for
p.000877: suicide;
p.000877: (9) evaluating and disseminating outcomes and best prac- tices of mental health and substance use
p.000877: disorder services at institutions of higher education; and
p.000877: (10) conducting other activities determined appropriate by the Secretary.
p.000877: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000877: to be appropriated
p.000877: $5,988,000 for each of fiscal years 2018 through 2022.
p.000877: (d) ANNUAL REPORT.—Not later than 2 years after the date of enactment of this subsection, the Secretary
p.000877: shall submit to Con- gress a report on the activities carried out by the center established under subsection (a)
p.000877: during the year involved, including the poten- tial effects of such activities, and the States, organizations, and in-
p.000877: stitutions that have worked with the center.
p.000877: øSection 520D was repealed by section 9017 of Public Law 114–255.¿
p.000877: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: 879
p.000879: PUBLIC HEALTH SERVICE ACT
p.000879: Sec. 520E
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p.000879: January 30, 2020
p.000879: SEC. 520E. ø290bb–36¿ YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
p.000879: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance
p.000879: Use, shall award grants or cooperative agreements to eligible entities to—
p.000879: (1) develop and implement State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention strate- gies in schools, educational institutions, juvenile justice sys- tems, substance use
p.000879: disorder programs, mental health pro- grams, foster care systems, and other child and youth support organizations;
p.000879: (2) support public organizations and private nonprofit or- ganizations actively involved in State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies and in the development
p.000879: and continuation of State-spon- sored statewide youth suicide early intervention and preven- tion strategies;
p.000879: (3) provide grants to institutions of higher education to co- ordinate the implementation of State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies;
p.000879: (4) collect and analyze data on State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention serv- ices that can be used to monitor the effectiveness of such serv- ices and for research, technical
p.000879: assistance, and policy develop- ment; and
p.000879: (5) assist eligible entities, through State-sponsored state- wide or tribal youth suicide early
p.000879: intervention and prevention strategies, in achieving targets for youth suicide reductions under title V of the
p.000879: Social Security Act.
p.000879: (b) ELIGIBLE ENTITY.—
p.000879: (1) DEFINITION.—In this section, the term ‘‘eligible entity’’ means—
p.000879: (A) a State;
p.000879: (B) a public organization or private nonprofit organiza- tion designated by a State to develop or direct the
p.000879: State- sponsored statewide youth suicide early intervention and prevention strategy; or
p.000879: (C) a Federally recognized Indian tribe or tribal orga- nization (as defined in the Indian
p.000879: Self-Determination and Education Assistance Act) or an urban Indian organization (as defined in the Indian Health
p.000879: Care Improvement Act) that is actively involved in the development and continu- ation of a tribal youth
p.000879: suicide early intervention and pre- vention strategy.
p.000879: (2) LIMITATION.—In carrying out this section, the Secretary shall ensure that a State does not receive more
p.000879: than 1 grant or cooperative agreement under this section at any 1 time. For purposes of the preceding sentence, a
p.000879: State shall be considered to have received a grant or cooperative agreement if the eligi- ble entity
p.000879: involved is the State or an entity designated by the State under paragraph (1)(B). Nothing in this paragraph
p.000879: shall be construed to apply to entities described in paragraph (1)(C).
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000879:
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p.000879: Sec. 520E PUBLIC HEALTH SERVICE ACT 880
p.000879: (3) CONSIDERATION.—In awarding grants under this sec- tion, the Secretary shall take into consideration
p.000879: the extent of the need of the applicant, including the incidence and preva- lence of suicide in the
p.000879: State and among the populations of focus, including rates of suicide determined by the Centers for Disease
p.000879: Control and Prevention for the State or population of focus.
p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: January 30, 2020
p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
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p.000881: child in a youth suicide early intervention and prevention program.
p.000881: (d) REQUIREMENT FOR DIRECT SERVICES.—Not less than 85 per- cent of grant funds received under this section shall be
p.000881: used to pro- vide direct services, of which not less than 5 percent shall be used for activities authorized under
p.000881: subsection (a)(3).
p.000881: (e) COORDINATION AND COLLABORATION.—
p.000881: (1) IN GENERAL.—In carrying out this section, the Sec- retary shall collaborate with relevant Federal agencies
p.000881: and sui- cide working groups responsible for early intervention and pre- vention services relating to youth suicide.
p.000881: (2) CONSULTATION.—In carrying out this section, the Sec- retary shall consult with—
p.000881: (A) State and local agencies, including agencies re- sponsible for early intervention and prevention
p.000881: services under title XIX of the Social Security Act, the State Chil- dren’s Health Insurance Program
p.000881: under title XXI of the Social Security Act, and programs funded by grants under title V of the Social Security Act;
p.000881: (B) local and national organizations that serve youth at risk for suicide and their families;
p.000881: (C) relevant national medical and other health and education specialty organizations;
p.000881: (D) youth who are at risk for suicide, who have sur- vived suicide attempts, or who are currently receiving
p.000881: care from early intervention services;
p.000881: (E) families and friends of youth who are at risk for suicide, who have survived suicide attempts, who
p.000881: are cur- rently receiving care from early intervention and preven- tion services, or who have completed
p.000881: suicide;
p.000881: (F) qualified professionals who possess the specialized knowledge, skills, experience, and relevant
p.000881: attributes needed to serve youth at risk for suicide and their families; and
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p.000881: January 30, 2020
p.000881: (G) third-party payers, managed care organizations, and related commercial industries.
p.000881: (3) POLICY DEVELOPMENT.—In carrying out this section, the Secretary shall—
p.000881: (A) coordinate and collaborate on policy development at the Federal level with the relevant
p.000881: Department of
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: Sec. 520E PUBLIC HEALTH SERVICE ACT 882
p.000881:
p.000881: Health and Human Services agencies and suicide working groups; and
p.000881: (B) consult on policy development at the Federal level with the private sector, including consumer, medical,
p.000881: sui- cide prevention advocacy groups, and other health and education professional-based organizations, with
p.000881: respect to State-sponsored statewide or tribal youth suicide early intervention and prevention strategies.
p.000881: (f) RULE OF CONSTRUCTION; RELIGIOUS AND MORAL ACCOMMO- DATION.—Nothing in this section shall be construed to
p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
p.000881: object based on the parents’ or legal guardians’ religious beliefs or moral objections.
p.000881: (g) EVALUATIONS AND REPORT.—
p.000881: (1) EVALUATIONS BY ELIGIBLE ENTITIES.—Not later than 18 months after receiving a grant or cooperative agreement
p.000881: under this section, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted
p.000881: by the entity con- cerning the effectiveness of the activities carried out under the grant or agreement.
p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
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p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
p.000883: private nonprofit organizations, political subdivisions, consortia of political subdivi- sions, consortia of
p.000883: States, or Federally recognized Indian tribes or tribal organizations to design early intervention and
p.000883: prevention strategies that will complement the State-sponsored statewide or tribal youth suicide early
p.000883: intervention and prevention strategies developed pursuant to section 520E.
p.000883: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall ensure that activities under this
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p.000885: PUBLIC HEALTH SERVICE ACT
p.000885: Sec. 520E–1
p.000885:
p.000885: (g) APPLICATION.—A public organization, private nonprofit or- ganization, political subdivision, consortium
p.000885: of political subdivi- sions, consortium of States, or Federally recognized Indian tribe or tribal organization
p.000885: receiving a grant or cooperative agreement under subsection (a) shall prepare and submit an application to
p.000885: the Secretary at such time, in such manner, and containing such infor- mation as the Secretary may reasonably
p.000885: require. Such application shall include a plan for the rigorous evaluation of activities funded under the grant or
p.000885: cooperative agreement, including a process and outcome evaluation.
p.000885: (h) DISTRIBUTION OF AWARDS.—In awarding grants and cooper- ative agreements under subsection (a), the Secretary
p.000885: shall ensure that such awards are distributed among the geographical regions of the United States and between
p.000885: urban and rural settings.
p.000885: (i) EVALUATION.—A public organization, private nonprofit orga- nization, political subdivision, consortium of
p.000885: political subdivisions, consortium of States, or Federally recognized Indian tribe or tribal organization receiving a
p.000885: grant or cooperative agreement under sub- section (a) shall prepare and submit to the Secretary at the end of the
p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
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p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
p.000885: with the Secretary of Education, may award grants on a competitive basis to institutions of higher education
p.000885: to enhance services for students with mental health or substance use disorders that can lead to school
p.000885: failure, such as depression, substance use disorders, and sui- cide attempts, prevent mental and substance use
p.000885: disorders, reduce stigma, and improve the identification and treatment for students at risk, so that students
p.000885: will successfully complete their studies.
p.000885: (b) USE OF FUNDS.—The Secretary may not make a grant to an institution of higher education under this section
p.000885: unless the in- stitution agrees to use the grant only for one or more of the fol- lowing:
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p.000885: (1) Educating students, families, faculty, and staff to in- crease awareness of mental and substance use
p.000885: disorders.
p.000885: (2) The operation of hotlines.
p.000885: (3) Preparing informational material.
p.000885: (4) Providing outreach services to notify students about available mental and substance use disorder services.
p.000885: (5) Administering voluntary mental and substance use dis- order screenings and assessments.
p.000885: (6) Supporting the training of students, faculty, and staff to respond effectively to students with
p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
p.000887: (1) A description of the population to be targeted by the program carried out under the grant, including
p.000887: veterans when- ever possible and appropriate, and of identified mental and substance use disorder needs of
p.000887: students at the institution of higher education.
p.000887: (2) A description of Federal, State, local, private, and insti- tutional resources currently available to address the
p.000887: needs de- scribed in paragraph (1) at the institution of higher education, which may include, as appropriate and in
p.000887: accordance with sub- section (b)(7), a plan to seek input from relevant stakeholders in the community,
p.000887: including appropriate public and private en- tities, in order to carry out the program under the grant.
p.000887: (3) A description of the outreach strategies of the institu- tion of higher education for promoting
p.000887: access to services, in- cluding a proposed plan for reaching those students most in need of mental health
p.000887: services.
p.000887: (4) A plan to evaluate program outcomes, including a de- scription of the proposed use of funds, the
p.000887: program objectives, and how the objectives will be met.
p.000887: (5) An assurance that the institution will submit a report to the Secretary each fiscal year on the
p.000887: activities carried out with the grant and the results achieved through those activi- ties.
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p.000887: (6) An outline of the objectives of the program carried out under the grant.
p.000887: (7) For an institution of higher education proposing to use the grant for an activity described in paragraph
p.000887: (8) or (9) of subsection (b), a description of the policies and procedures of the institution of higher
p.000887: education that are related to applica- ble laws regarding access to, and sharing of, treatment records of students
p.000887: at any campus-based mental health center or part- ner organization, including the policies and State laws gov-
p.000887: erning when such records can be accessed and shared for non- treatment purposes and a description of the process
p.000887: used by the institution of higher education to notify students of these policies and procedures,
p.000887: including the extent to which written consent is required.
p.000887: (8) An assurance that grant funds will be used to supple- ment and not supplant any other Federal, State, or
p.000887: local funds available to carry out activities of the type carried out under the grant.
p.000887: (e) REQUIREMENT OF MATCHING FUNDS.—
p.000887: (1) IN GENERAL.—The Secretary may make a grant under this section to an institution of higher education only if
p.000887: the in- stitution agrees to make available (directly or through dona- tions from public or private entities)
p.000887: non-Federal contributions
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: Sec. 520E–3 PUBLIC HEALTH SERVICE ACT 888
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p.000887: January 30, 2020
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p.000887: in an amount that is not less than $1 for each $1 of Federal funds provided in the grant, toward the costs
p.000887: of activities car- ried out with the grant (as described in subsection (b)) and other activities by the
p.000887: institution to reduce student mental health and substance use disorders.
p.000887: (2) DETERMINATION OF AMOUNT CONTRIBUTED.—Non-Fed- eral contributions required under paragraph (1) may be in cash
p.000887: or in kind. Amounts provided by the Federal Government, or services assisted or subsidized to any significant
p.000887: extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.000887: contributions.
p.000887: (3) WAIVER.—The Secretary may waive the requirement established in paragraph (1) with respect to an
p.000887: institution of higher education if the Secretary determines that extraor- dinary need at the institution
p.000887: justifies the waiver.
p.000887: (f) REPORTS.—For each fiscal year that grants are awarded under this section, the Secretary shall conduct
p.000887: a study on the re- sults of the grants and submit to the Congress a report on such re- sults that includes the
p.000887: following:
p.000887: (1) An evaluation of the grant program outcomes, includ- ing a summary of activities carried out with the grant
p.000887: and the results achieved through those activities.
p.000887: (2) Recommendations on how to improve access to mental health and substance use disorder services at
p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
p.000887: (g) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000887: section 101 of the Higher Education Act of 1965.
p.000887: (h) TECHNICAL ASSISTANCE.—The Secretary may provide tech- nical assistance to grantees in carrying out this
p.000887: section.
p.000887: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000887: to be appropriated
p.000887: $7,000,000 for each of fiscal years 2018 through 2022.
p.000887: SEC. 520E–3. ø290bb–36c¿ NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.000887: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Suicide
p.000887: Prevention Lifeline program (referred to in this section as the ‘‘program’’), authorized under section 520A
p.000887: and in effect prior to the date of enactment of the Helping Families in Mental Health Crisis Reform Act of
p.000887: 2016.
p.000887: (b) ACTIVITIES.—In maintaining the program, the activities of the Secretary shall include—
p.000887: (1) coordinating a network of crisis centers across the United States for providing suicide prevention and
p.000887: crisis inter- vention services to individuals seeking help at any time, day or night;
p.000887: (2) maintaining a suicide prevention hotline to link callers to local emergency, mental health, and social
p.000887: services re- sources; and
p.000887: (3) consulting with the Secretary of Veterans Affairs to en- sure that veterans calling the suicide prevention
p.000887: hotline have access to a specialized veterans’ suicide prevention hotline.
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: PUBLIC HEALTH SERVICE ACT
p.000891: Sec. 520G
p.000891:
p.000891: (1) local crisis response services and measures for individ- uals receiving crisis planning and early
p.000891: intervention supports;
p.000891: (2) individuals reporting improved functional outcomes;
p.000891: and
p.000891: (3) individuals receiving regular followup care following a
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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
p.000891: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000891: Sec. 520G PUBLIC HEALTH SERVICE ACT 892
p.000891:
p.000891: (ii) there has been relevant interagency collabora- tion between the appropriate criminal justice, mental health,
p.000891: and substance use disorder systems; and
p.000891: (iii) the Federal support provided will be used to supplement, and not supplant, State, local,
p.000891: Indian tribe, or tribal organization sources of funding that would otherwise be available;
p.000891: (B) demonstrate that the diversion program will be in- tegrated with an existing system of care for those with
p.000891: mental illness;
p.000891: (C) explain the applicant’s inability to fund the pro- gram adequately without Federal assistance;
p.000891: (D) specify plans for obtaining necessary support and continuing the proposed program following the
p.000891: conclusion of Federal support; and
p.000891: (E) describe methodology and outcome measures that will be used in evaluating the program.
p.000891: (d) SPECIAL CONSIDERATION REGARDING VETERANS.—In award- ing grants under subsection (a), the Secretary shall, as
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p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
p.000893: (i) AUTHORIZATION OF APPROPRIATION.—There is authorized to be appropriated to carry out this subsection
p.000893: $40,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 through 2003.
p.000893: SEC. 520J. ø290bb–41¿ MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.000893: (a) IN GENERAL.—The Secretary shall award grants in accord- ance with the provisions of this section.
p.000893: (b) MENTAL HEALTH AWARENESS TRAINING GRANTS.—
p.000893: (1) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian tribes,
p.000893: tribal or- ganizations, and nonprofit private entities to train teachers and other relevant school personnel
p.000893: to recognize symptoms of childhood and adolescent mental disorders, to refer family members to the
p.000893: appropriate mental health services if nec- essary, to train emergency services personnel veterans, law en-
p.000893: forcement, and other categories of individuals, as determined by the Secretary, to identify and appropriately
p.000893: respond to per- sons with a mental illness, and to provide education to such
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: PUBLIC HEALTH SERVICE ACT
p.000895: Sec. 520K
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p.000895: teachers and personnel regarding resources that are available in the community for individuals with a mental
p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
p.000895: (4) APPLICATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that desires a grant under this subsection shall submit an ap- plication to the Secretary at such
p.000895: time, in such manner, and containing such information as the Secretary may require, in- cluding a plan for
p.000895: the rigorous evaluation of activities that are carried out with funds received under a grant under this sub-
p.000895: section.
p.000895: (5) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private en- tity receiving a grant under this subsection shall use funds from such grant for
p.000895: evidence-based programs that provide training and education in accordance with paragraph (1) on matters
p.000895: including—
p.000895: (A) recognizing the signs and symptoms of mental ill- ness; and
p.000895: (B)(i) resources available in the community for individ- uals with a mental illness and other relevant resources; or
p.000895: (ii) safely de-escalating crisis situations involving indi- viduals with a mental illness.
p.000895: (6) EVALUATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that receives a grant under this subsection shall prepare and submit an evaluation to the
p.000895: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require,
p.000895: including an evaluation of activities carried out with funds received under the grant under this subsection and a
p.000895: process and outcome evaluation.
p.000895: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this
p.000895: subsection$14,693,000 for each of fiscal years 2018 through 2022.
p.000895: SEC. 520K. ø290bb–42¿ INTEGRATION INCENTIVE GRANTS AND COOP- ERATIVE AGREEMENTS.
p.000895: (a) DEFINITIONS.—In this section:
p.000895: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a State, or other appropriate State agency, in
p.000895: collaboration with 1 or more qualified community programs as described in sec- tion 1913(b)(1) or 1 or
p.000895: more community health centers as de- scribed in section 330.
p.000895: (2) INTEGRATED CARE.—The term ‘‘integrated care’’ means collaborative models or practices offering mental
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p.000897: and extracurricular activities.
p.000897: (g) TECHNICAL ASSISTANCE FOR PRIMARY-BEHAVIORAL HEALTH CARE INTEGRATION.—
p.000897: (1) IN GENERAL.—The Secretary may provide appropriate information, training, and technical assistance to
p.000897: eligible enti- ties that receive a grant or cooperative agreement under this section, in order to help
p.000897: such entities meet the requirements of this section, including assistance with—
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000897:
p.000897: els;
p.000897: (A) development and selection of integrated care mod-
p.000897: (B) dissemination of evidence-based interventions in
p.000897: integrated care;
p.000897: (C) establishment of organizational practices to sup- port operational and administrative success; and
p.000897: (D) other activities, as the Secretary determines ap- propriate.
p.000897: (2) ADDITIONAL DISSEMINATION OF TECHNICAL INFORMA- TION.—The information and resources provided by the
p.000897: Sec- retary under paragraph (1) shall, as appropriate, be made available to States, political
p.000897: subdivisions of States, Indian tribes or tribal organizations (as defined in section 4 of the In- dian
p.000897: Self-Determination and Education Assistance Act), out- patient mental health and addiction treatment
p.000897: centers, com- munity mental health centers that meet the criteria under sec- tion 1913(c), certified community
p.000897: behavioral health clinics de- scribed in section 223 of the Protecting Access to Medicare Act of 2014, primary care
p.000897: organizations such as Federally qualified health centers or rural health clinics as defined in section
p.000897: 1861(aa) of the Social Security Act, other community-based or- ganizations, or other entities engaging in
p.000897: integrated care ac- tivities, as the Secretary determines appropriate.
p.000897: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
p.000897: tion, there are authorized to be appropriated $51,878,000 for each of fiscal years 2018 through 2022.
p.000897: SEC. 520L. ø290bb–43¿ ADULT SUICIDE PREVENTION.
p.000897: (a) GRANTS.—
p.000897: (1) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities described in
p.000897: paragraph (2) to imple- ment suicide prevention and intervention programs, for indi- viduals who are 25
p.000897: years of age or older, that are designed to raise awareness of suicide, establish referral processes, and im-
p.000897: prove care and outcomes for such individuals who are at risk of suicide.
p.000897: (2) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a
p.000897: community-based pri- mary care or behavioral health care setting, an emergency de- partment, a State mental health
p.000897: agency (or State health agen- cy with mental or behavioral health functions), public health agency, a
p.000897: territory of the United States, or an Indian tribe or tribal organization (as the terms ‘‘Indian tribe’’
p.000897: and ‘‘tribal or- ganization’’ are defined in section 4 of the Indian Self-Deter- mination and Education
p.000897: Assistance Act).
p.000897: (3) USE OF FUNDS.—The grants awarded under paragraph
p.000897: (1) shall be used to implement programs, in accordance with such paragraph, that include one or more of the
p.000897: following com- ponents:
p.000897:
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p.000897: January 30, 2020
p.000897: (A) Screening for suicide risk, suicide intervention services, and services for referral for treatment for
p.000897: individ- uals at risk for suicide.
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000899: PUBLIC HEALTH SERVICE ACT
p.000899: Sec. 520M
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p.000899: (b) EVALUATIONS AND TECHNICAL ASSISTANCE.—The Assistant Secretary shall—
p.000899: (1) evaluate the activities supported by grants awarded under subsection (a), and disseminate, as appropriate,
p.000899: the find- ings from the evaluation; and
p.000899: (2) provide appropriate information, training, and technical assistance, as appropriate, to eligible entities
p.000899: that receive a grant under this section, in order to help such entities to meet the requirements of this section,
p.000899: including assistance with se- lection and implementation of evidence-based interventions and frameworks
p.000899: to prevent suicide.
p.000899: (c) DURATION.—A grant under this section shall be for a period of not more than 5 years.
p.000899: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $30,000,000
p.000899: for the pe- riod of fiscal years 2018 through 2022.
p.000899: SEC. 520M. ø290bb–44¿ ASSERTIVE COMMUNITY TREATMENT GRANT PROGRAM.
p.000899: (a) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities—
p.000899: (1) to establish assertive community treatment programs for adults with a serious mental illness; or
p.000899: (2) to maintain or expand such programs.
p.000899: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a State,
p.000899: political subdivision of a State, Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.000899: Indian Self-Determination and Education Assist- ance Act), mental health system, health care facility, or any
p.000899: other entity the Assistant Secretary deems appropriate.
p.000899: (c) SPECIAL CONSIDERATION.—In selecting among applicants for a grant under this section, the Assistant Secretary
p.000899: may give special consideration to the potential of the applicant’s program to reduce hospitalization,
p.000899: homelessness, and involvement with the criminal justice system while improving the health and social
p.000899: outcomes of the patient.
p.000899: (d) ADDITIONAL ACTIVITIES.—The Assistant Secretary shall—
p.000899: (1) not later than the end of fiscal year 2021, submit a re- port to the appropriate congressional committees on
p.000899: the grant program under this section, including an evaluation of—
p.000899: (A) any cost savings and public health outcomes such as mortality, suicide, substance use disorders,
p.000899: hospitaliza- tion, and use of services;
p.000899: (B) rates of involvement with the criminal justice sys- tem of patients;
p.000899: (C) rates of homelessness among patients; and
p.000899: (D) patient and family satisfaction with program par- ticipation; and
p.000899: (2) provide appropriate information, training, and technical assistance to grant recipients under this section
p.000899: to help such
p.000899: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000899:
p.000899:
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p.000905: (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any
p.000905: amounts from payments made to the State under section 521 may not conceal or fail to disclose any such event
p.000905: with the intent of securing such an amount that the person is not authorized to receive or securing such an
p.000905: amount in an amount greater than the amount the person is authorized to receive.
p.000905: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates a prohibition established in
p.000905: subsection (a) may for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.000905: for not more than 5 years, or both.
p.000905: SEC. 533. ø290cc–33¿ NONDISCRIMINATION.
p.000905: (a) IN GENERAL.—
p.000905: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000907: 907
p.000907: PUBLIC HEALTH SERVICE ACT
p.000907: Sec. 534
p.000907:
p.000907: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.000907: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.000907: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.000907: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.000907: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section
p.000907: 521 shall be considered to be programs and activities receiving Federal fi- nancial assistance.
p.000907: (2) PROHIBITION.—No person shall on the ground of sex or religion be excluded from participation in, be denied the
p.000907: bene- fits of, or be subjected to discrimination under, any program or activity funded in whole or in part with
p.000907: funds made available under section 521.
p.000907: (b) ENFORCEMENT.—
p.000907: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.000907: entity that has received a payment pursuant to section 521, has failed to comply with a provision of law
p.000907: referred to in subsection (a)(1), with subsection (a)(2), or with an applicable regulation (includ- ing one prescribed
p.000907: to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the State and shall re-
p.000907: quest the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days,
p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
p.000907: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.000907: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.000907: Rights Act of 1964, as may be applicable; or
p.000907: (C) take such other actions as may be authorized by
p.000907:
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p.000907: January 30, 2020
p.000907: law.
p.000907: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000907: Sec. 535 PUBLIC HEALTH SERVICE ACT 908
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p.000909: January 30, 2020
p.000909:
p.000909: pension or revocation of such other Federal support for such hospital or outpatient facility.
p.000909: (2) DEPARTMENT OF VETERANS AFFAIRS.—The Secretary of Veterans Affairs, acting through the Under
p.000909: Secretary for Health, shall, to the maximum feasible extent consistent with their responsibilities under
p.000909: title 38, United States Code, pre- scribe regulations making applicable the regulations prescribed by the
p.000909: Secretary under paragraph (1) to the provision of hos- pital care, nursing home care, domiciliary care,
p.000909: and medical services under such title 38 to veterans suffering from sub- stance abuse. In prescribing
p.000909: and implementing regulations pursuant to this paragraph, the Secretary shall, from time to time, consult
p.000909: with the Secretary of Health and Human Serv- ices in order to achieve the maximum possible coordination
p.000909: of the regulations, and the implementation thereof, which they each prescribe.
p.000909: SEC. 543. ø290dd–2¿ CONFIDENTIALITY OF RECORDS.
p.000909: (a) REQUIREMENT.—Records of the identity, diagnosis, prog- nosis, or treatment of any patient which are
p.000909: maintained in connec- tion with the performance of any program or activity relating to substance abuse
p.000909: education, prevention, training, treatment, reha- bilitation, or research, which is conducted, regulated, or
p.000909: directly or indirectly assisted by any department or agency of the United States shall, except as provided
p.000909: in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly
p.000909: authorized under subsection (b).
p.000909: (b) PERMITTED DISCLOSURE.—
p.000909: (1) CONSENT.—The content of any record referred to in subsection (a) may be disclosed in accordance with
p.000909: the prior written consent of the patient with respect to whom such record is maintained, but only to
p.000909: such extent, under such cir- cumstances, and for such purposes as may be allowed under regulations
p.000909: prescribed pursuant to subsection (g).
p.000909: (2) METHOD FOR DISCLOSURE.—Whether or not the patient, with respect to whom any given record referred to in
p.000909: sub- section (a) is maintained, gives written consent, the content of such record may be disclosed as follows:
p.000909: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
p.000909: (B) To qualified personnel for the purpose of con- ducting scientific research, management audits,
p.000909: financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any
p.000909: individual patient in any report of such research, audit, or evaluation, or other- wise disclose patient identities
p.000909: in any manner.
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p.000913: ing medication-assisted treatment and appropriate counseling and behavioral therapies.
p.000913: (d) EVALUATIONS BY RECIPIENTS.—As a condition of receipt of a grant under this section, an eligible
p.000913: entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities
p.000913: funded by the grant which contains such information as the Secretary may reasonably require.
p.000913: (e) REPORTS BY THE SECRETARY.—Not later than 5 years after the date on which the first grant under this
p.000913: section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of
p.000913: the Senate a report aggregating the in- formation received from the grant recipients for such year under
p.000913: subsection (d) and evaluating the outcomes achieved by the pro- grams funded by grants awarded under this
p.000913: section.
p.000913: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section, $5,000,000 for
p.000913: the period of fiscal years 2017 through 2021.
p.000913: SEC. 545. ø290ee¿ OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION GRANT PROGRAMS.
p.000913: (a) GRANTS TO STATES.—The Secretary shall make grants to States to—
p.000913: (1) implement strategies for pharmacists to dispense a drug or device approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, as
p.000913: appropriate, pursuant to a stand- ing order;
p.000913: (2) encourage pharmacies to dispense opioid overdose re- versal medication pursuant to a standing order;
p.000913: (3) develop or provide training materials that persons au- thorized to prescribe or dispense a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose may use to educate the public concerning—
p.000913: (A) when and how to safely administer such drug or device; and
p.000913: (B) steps to be taken after administering such drug or device; and
p.000913: (4) educate the public concerning the availability of drugs or devices approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose without
p.000913: a person-specific prescription.
...

p.000915: duration of the grant, submit a report to the Secretary evaluating the progress of the activities
p.000915: supported through the grant. Such reports shall include informa- tion on the number of pharmacies in the State
p.000915: that dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for
p.000915: emergency treatment of known or suspected opioid overdose under a standing order, and other
p.000915: information as the Secretary determines appropriate to evaluate the use of grant funds.
p.000915: (g) DEFINITIONS.—In this section the term ‘‘standing order’’ means a document prepared by a person
p.000915: authorized to prescribe medication that permits another person to acquire, dispense, or ad- minister medication
p.000915: without a person-specific prescription.
p.000915: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000915: (1) IN GENERAL.—To carry out this section, there are au- thorized to be appropriated $5,000,000 for the
p.000915: period of fiscal years 2017 through 2019.
p.000915: (2) ADMINISTRATIVE COSTS.—Not more than 3 percent of the amounts made available to carry out this
p.000915: section may be used by the Secretary for administrative expenses of carrying out this section.
p.000915: SEC. 546. ø290ee–1¿ FIRST RESPONDER TRAINING.
p.000915: (a) PROGRAM AUTHORIZED.—The Secretary shall make grants to States, local governmental entities, and Indian
p.000915: tribes and tribal organizations (as defined in section 4 of the Indian Self-Determina- tion and Education Assistance
p.000915: Act) to allow first responders and members of other key community sectors to administer a drug or
p.000915: device approved or cleared under the Federal Food, Drug, and Cos-
p.000915: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: Sec. 546 PUBLIC HEALTH SERVICE ACT 916
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p.000915: metic Act for emergency treatment of known or suspected opioid overdose.
p.000915: (b) APPLICATION.—
p.000915: (1) IN GENERAL.—An entity seeking a grant under this sec- tion shall submit an application to the Secretary—
p.000915: (A) that meets the criteria under paragraph (2); and
p.000915: (B) at such time, in such manner, and accompanied by such information as the Secretary may require.
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p.000919: of the Controlled Substances Act.
p.000919: (b) GRANTS FOR COMPREHENSIVE OPIOID ABUSE RESPONSE.—
p.000919: (1) IN GENERAL.—The Secretary shall award grants to States, and combinations of States, to implement an
p.000919: integrated opioid abuse response initiative.
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: Sec. 548 PUBLIC HEALTH SERVICE ACT 920
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p.000919: (2) PURPOSES.—A State receiving a grant under this sec- tion shall establish a comprehensive response
p.000919: plan to opioid abuse, which may include—
p.000919: (A) education efforts around opioid use, treatment, and addiction recovery, including education of residents,
p.000919: med- ical students, and physicians and other prescribers of schedule II, III, or IV controlled
p.000919: substances on relevant prescribing guidelines, the prescription drug monitoring program of the State
p.000919: described in subparagraph (B), and overdose prevention methods;
p.000919: (B) establishing, maintaining, or improving a com- prehensive prescription drug monitoring program to track
p.000919: dispensing of schedule II, III, or IV controlled substances, which may—
p.000919: (i) provide for data sharing with other States; and
p.000919: (ii) allow all individuals authorized by the State to write prescriptions for schedule II, III, or IV controlled
p.000919: substances to access the prescription drug monitoring program of the State;
p.000919: (C) developing, implementing, or expanding prescrip- tion drug and opioid addiction treatment programs by—
p.000919: (i) expanding the availability of treatment for pre- scription drug and opioid addiction, including medica-
p.000919: tion-assisted treatment and behavioral health therapy, as appropriate;
p.000919: (ii) developing, implementing, or expanding screening for individuals in treatment for prescription drug
p.000919: and opioid addiction for hepatitis C and HIV, and treating or referring those individuals if clinically ap-
p.000919: propriate; or
p.000919: (iii) developing, implementing, or expanding recov- ery support services and programs at high schools or
p.000919: institutions of higher education;
p.000919: (D) developing, implementing, and expanding efforts to prevent overdose death from opioid abuse or addiction to
p.000919: prescription medications and opioids; and
p.000919: (E) advancing the education and awareness of the pub- lic, providers, patients, consumers, and other appropriate
p.000919: entities regarding the dangers of opioid abuse, safe dis- posal of prescription medications, and detection
p.000919: of early warning signs of opioid use disorders.
p.000919: (3) APPLICATION.—A State seeking a grant under this sec- tion shall submit to the Secretary an application in such
p.000919: form, and containing such information, as the Secretary may reason- ably require.
p.000919: (4) USE OF FUNDS.—A State that receives a grant under this section shall use the grant for the cost, including
p.000919: the cost for technical assistance, training, and administration expenses, of carrying out an integrated opioid
p.000919: abuse response initiative as outlined by the State’s comprehensive response plan to opioid abuse established
p.000919: under paragraph (2).
p.000919: (5) PRIORITY CONSIDERATIONS.—In awarding grants under this section, the Secretary shall, as appropriate,
p.000919: give priority to a State that—
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000921: PUBLIC HEALTH SERVICE ACT
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p.000921: (7) STATES WITH LOCAL PRESCRIPTION DRUG MONITORING PROGRAMS.—
p.000921: (A) IN GENERAL.—In the case of a State that does not have a prescription drug monitoring program, a county or
p.000921: other unit of local government within the State that has a prescription drug monitoring program shall be
p.000921: treated as a State for purposes of this section, including for purposes of eligibility for grants under paragraph (1).
p.000921: (B) PLAN FOR INTEROPERABILITY.—In submitting an application to the Secretary under paragraph (3), a county or
p.000921: other unit of local government shall submit a plan out- lining the methods such county or unit of local government
p.000921: shall use to ensure the capability of data sharing with other counties and units of local government
p.000921: within the state and with other States, as applicable.
p.000921: (c) AUTHORIZATION OF FUNDING.—For the purpose of carrying out this section, there are authorized to be
p.000921: appropriated $5,000,000 for each of fiscal years 2017 through 2021.
p.000921: SEC. 549. ø290ee–4¿ MENTAL AND BEHAVIORAL HEALTH OUTREACH AND EDUCATION ON COLLEGE CAMPUSES.
p.000921: (a) PURPOSE.—It is the purpose of this section to increase ac- cess to, and reduce the stigma associated
p.000921: with, mental health serv- ices to ensure that students at institutions of higher education have the support
p.000921: necessary to successfully complete their studies.
p.000921: (b) NATIONAL PUBLIC EDUCATION CAMPAIGN.—The Secretary, acting through the Assistant Secretary and in
p.000921: collaboration with the Director of the Centers for Disease Control and Prevention, shall convene an
p.000921: interagency, public-private sector working group to plan, establish, and begin coordinating and evaluating
p.000921: a tar- geted public education campaign that is designed to focus on men- tal and behavioral health on the campuses of
p.000921: institutions of higher education. Such campaign shall be designed to—
p.000921: (1) improve the general understanding of mental health and mental disorders;
p.000921: (2) encourage help-seeking behaviors relating to the pro- motion of mental health, prevention of mental
p.000921: disorders, and treatment of such disorders;
p.000921: (3) make the connection between mental and behavioral health and academic success; and
p.000921: (4) assist the general public in identifying the early warn- ing signs and reducing the stigma of mental illness.
p.000921: (c) COMPOSITION.—The working group convened under sub- section (b) shall include—
p.000921: (1) mental health consumers, including students and fam- ily members;
p.000921: (2) representatives of institutions of higher education;
p.000921: (3) representatives of national mental and behavioral health associations and associations of
p.000921: institutions of higher education;
p.000921: (4) representatives of health promotion and prevention or- ganizations at institutions of higher education;
p.000921: (5) representatives of mental health providers, including community mental health centers; and
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p.000923: (6) representatives of private-sector and public-sector groups with experience in the development of
p.000923: effective public health education campaigns.
p.000923: (d) PLAN.—The working group under subsection (b) shall de- velop a plan that—
p.000923: (1) targets promotional and educational efforts to the age population of students at institutions of
p.000923: higher education and individuals who are employed in settings of institutions of higher education, including
p.000923: through the use of roundtables;
p.000923: (2) develops and proposes the implementation of research- based public health messages and activities;
p.000923: (3) provides support for local efforts to reduce stigma by using the National Health Information Center
p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
p.000923: for the pe- riod of fiscal years 2018 through 2022.
p.000923: SEC. 550. 15 ø290ee–5¿ NATIONAL RECOVERY HOUSING BEST PRAC- TICES.
p.000923: (a) BEST PRACTICES FOR OPERATING RECOVERY HOUSING.—
p.000923: (1) IN GENERAL.—The Secretary, in consultation with the individuals and entities specified in paragraph
p.000923: (2), shall iden- tify or facilitate the development of best practices, which may include model laws
p.000923: for implementing suggested minimum standards, for operating recovery housing.
p.000923: (2) CONSULTATION.—In carrying out the activities de- scribed in paragraph (1), the Secretary shall
p.000923: consult with, as appropriate—
p.000923: (A) relevant divisions of the Department of Health and Human Services, including the Substance Abuse and Men- tal
p.000923: Health Services Administration, the Office of Inspector General, the Indian Health Service, and the Centers for
p.000923: Medicare & Medicaid Services;
p.000923: (B) the Secretary of Housing and Urban Development;
p.000923: (C) directors or commissioners, as applicable, of State health departments, tribal health departments, State
p.000923: Med- icaid programs, and State insurance agencies;
p.000923: (D) representatives of health insurance issuers;
p.000923: (E) national accrediting entities and reputable pro- viders of, and analysts of, recovery housing
p.000923: services, in- cluding Indian tribes, tribal organizations, and tribally
p.000923:
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p.000923: January 30, 2020
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p.000923: consultation with appro- priate individuals and entities described in subsections (a)(2) and (b)(2), shall
p.000923: consider how recovery housing is able to support recov- ery and prevent relapse, recidivism, or overdose (including
p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: 925
p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
p.000925: Disorder Education for purposes of im- proving health professional training resources with respect to sub- stance
p.000925: use disorder prevention, treatment, and recovery.
p.000925: (b) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under subsection (a), an entity shall—
p.000925: (1) be an accredited entity that offers education to students in various health professions, which may include—
p.000925: (A) a teaching hospital;
p.000925: (B) a medical school;
p.000925: (C) a certified behavioral health clinic; or
p.000925: (D) any other health professions school, school of pub- lic health, or Cooperative Extension Program at institu-
p.000925: tions of higher education, as defined in section 101 of the Higher Education Act of 1965, engaged in
p.000925: the prevention, treatment, or recovery of substance use disorders;
p.000925: (2) demonstrate community engagement and partnerships with community stakeholders, including entities
p.000925: that train health professionals, mental health counselors, social workers, peer recovery specialists,
p.000925: substance use treatment programs, community health centers, physician offices, certified behav- ioral health
p.000925: clinics, research institutions, and law enforcement; and
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p.000925: January 30, 2020
p.000925: (3) submit to the Secretary an application containing such information, at such time, and in such manner, as
p.000925: the Sec- retary may require.
p.000925: (c) ACTIVITIES.—An entity receiving an award under this sec- tion shall develop, evaluate, and
p.000925: distribute evidence-based re- sources regarding the prevention and treatment of, and recovery from,
p.000925: substance use disorders. Such resources may include informa- tion on—
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000925: Sec. 552 PUBLIC HEALTH SERVICE ACT 926
p.000925:
p.000925: (1) the neurology and pathology of substance use disorders;
...

p.000925: other serv- ices for individuals with a substance use disorder.
p.000925: (2) SUBMISSION OF APPLICATION.—In order to be eligible for a grant under subsection (a), an entity shall
p.000925: submit an applica- tion to the Secretary at such time and in such manner as the Secretary may require. Such
p.000925: application shall include—
p.000925: (A) evidence that such entity carries out, or is capable of coordinating with other entities to carry out, the activi-
p.000925: ties described in subsection (g); and
p.000925: (B) such other information as the Secretary may re- quire.
p.000925: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000927: 927
p.000927: PUBLIC HEALTH SERVICE ACT
p.000927: Sec. 552
p.000927:
p.000927: (e) PRIORITY.—In awarding grants under subsection (a), the Secretary shall give priority to eligible entities—
p.000927: (1) located in a State with an age-adjusted rate of drug overdose deaths that is above the national
p.000927: overdose mortality rate, as determined by the Director of the Centers for Disease Control and Prevention; or
p.000927: (2) serving an Indian Tribe (as defined in section 4 of the Indian Self-Determination and Education
p.000927: Assistance Act) with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate,
p.000927: as determined through appro- priate mechanisms determined by the Secretary in consultation with Indian Tribes.
p.000927: (f) PREFERENCE.—In awarding grants under subsection (a), the Secretary may give preference to eligible entities
p.000927: utilizing tech- nology-enabled collaborative learning and capacity building models, including such models as defined
p.000927: in section 2 of the Expanding Ca- pacity for Health Outcomes Act (Public Law 114–270; 130 Stat. 1395), to
p.000927: conduct the activities described in this section.
p.000927: (g) CENTER ACTIVITIES.—Each Center shall, at a minimum, carry out the following activities directly,
p.000927: through referral, or through contractual arrangements, which may include carrying out such activities through
p.000927: technology-enabled collaborative learning and capacity building models described in subsection (f):
p.000927: (1) TREATMENT AND RECOVERY SERVICES.—Each Center shall—
p.000927:
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p.000927: January 30, 2020
p.000927: (A) Ensure that intake, evaluations, and periodic pa- tient assessments meet the individualized clinical needs
p.000927: of patients, including by reviewing patient placement in treatment settings to support meaningful recovery.
p.000927: (B) Provide the full continuum of treatment services, including—
p.000927: (i) all drugs and devices approved or cleared under the Federal Food, Drug, and Cosmetic Act and all bio- logical
p.000927: products licensed under section 351 of this Act to treat substance use disorders or reverse overdoses, pursuant
p.000927: to Federal and State law;
p.000927: (ii) medically supervised withdrawal management, that includes patient evaluation, stabilization, and
p.000927: readiness for and entry into treatment;
p.000927: (iii) counseling provided by a program counselor or other certified professional who is licensed and quali- fied
p.000927: by education, training, or experience to assess the psychological and sociological background of patients, to
p.000927: contribute to the appropriate treatment plan for the patient, and to monitor patient progress;
p.000927: (iv) treatment, as appropriate, for patients with co-occurring substance use and mental disorders;
p.000927: (v) testing, as appropriate, for infections com- monly associated with illicit drug use;
p.000927: (vi) residential rehabilitation, and outpatient and intensive outpatient programs;
p.000927: (vii) recovery housing;
p.000927: (viii) community-based and peer recovery support services;
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000927:
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p.000927: Sec. 552 PUBLIC HEALTH SERVICE ACT 928
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p.000927: January 30, 2020
p.000927:
p.000927: (ix) job training, job placement assistance, and continuing education assistance to support reintegra- tion
p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
p.000927: (h) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant awarded under subsection (a), not later
p.000927: than 90 days after the end of the first year of the grant period, and annually thereafter for the
p.000927: duration of the grant period (including the dura- tion of any renewal period for such grant), the entity shall submit
p.000927: data, as appropriate, to the Secretary regarding—
p.000927: (1) the programs and activities funded by the grant;
p.000927: (2) health outcomes of the population of individuals with a substance use disorder who received services
p.000927: from the Cen-
p.000927: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000927:
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p.000929: in subsection (g)(1)(B).
p.000929: (i) PRIVACY.—The provisions of this section, including with re- spect to data reporting and program
p.000929: oversight, shall be subject to all applicable Federal and State privacy laws.
p.000929: (j) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $10,000,000 for each of fiscal
p.000929: years 2019 through 2023 for purposes of carrying out this section.
p.000929: PART E—CHILDREN WITH SERIOUS EMOTIONAL DISTURBANCES
p.000929: SEC. 561. ø290ff¿ COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CHILDREN WITH SERIOUS
p.000929: EMOTIONAL DISTURBANCES.
p.000929: (a) GRANTS TO CERTAIN PUBLIC ENTITIES.—
p.000929: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Center for Mental Health Services,
p.000929: shall make grants to public entities for the purpose of providing com- prehensive community mental health
p.000929: services to children with a serious emotional disturbance, which may include efforts to identify and serve
p.000929: children at risk.
p.000929: (2) DEFINITION OF PUBLIC ENTITY.—For purposes of this part, the term ‘‘public entity’’ means any
p.000929: State, any political subdivision of a State, and any Indian tribe or tribal organiza- tion (as defined in section
p.000929: 4(b) and section 4(c) of the Indian Self-Determination and Education Assistance Act).
p.000929: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000929: (1) REQUIREMENT OF STATUS AS GRANTEE UNDER PART B OF TITLE XIX.—The Secretary may make a grant under
p.000929: subsection
p.000929: (a) to a public entity only if—
p.000929: (A) in the case of a public entity that is a State, the State is such a grantee under section 1911;
p.000929: (B) in the case of a public entity that is a political sub- division of a State, the State in which the political
p.000929: subdivi- sion is located is such a grantee; and
p.000929: (C) in the case of a public entity that is an Indian tribe or tribal organization, the State in which the
p.000929: tribe or tribal organization is located is such a grantee.
p.000929: (2) REQUIREMENT OF STATUS AS MEDICAID PROVIDER.—
p.000929: (A) Subject to subparagraph (B), the Secretary may make a grant under subsection (a) only if, in the
p.000929: case of any service under such subsection that is covered in the State plan approved under title XIX of the
p.000929: Social Security Act for the State involved—
p.000929: (i) the public entity involved will provide the serv- ice directly, and the entity has entered into a partici-
p.000929: pation agreement under the State plan and is quali- fied to receive payments under such plan; or
p.000929: (ii) the public entity will enter into an agreement with an organization under which the organization
p.000929: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000931: (B) the grant under such section 561(a), and the non- Federal contributions made with respect to the grant,
p.000931: will not be expended to pay the costs of providing such non- mental health services to any individual.
p.000931: (2) SPECIFICATION OF NON-MENTAL HEALTH SERVICES.—The providers referred to in paragraph (1) are providers of
p.000931: medical services other than mental health services, providers of edu- cational services, providers of
p.000931: vocational counseling and voca- tional rehabilitation services, and providers of protection and advocacy
p.000931: services with respect to mental health.
p.000931: (3) FACILITATION OF SERVICES OF CERTAIN PROGRAMS.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will, for purposes of para- graph (1), enter into a
p.000931: memorandum of understanding regard- ing facilitation of—
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000933: 933
p.000933: PUBLIC HEALTH SERVICE ACT
p.000933: Sec. 562
p.000933:
p.000933: (A) services available pursuant to title XIX of the So- cial Security Act, including services regarding
p.000933: early peri- odic screening, diagnosis, and treatment;
p.000933: (B) services available under parts B and C of the Indi- viduals with Disabilities Education Act; and
p.000933: (C) services available under other appropriate pro- grams, as identified by the Secretary.
p.000933: (e) GENERAL PROVISIONS REGARDING SERVICES OF SYSTEM.—
p.000933: (1) CASE MANAGEMENT SERVICES.—A funding agreement for a grant under section 561(a) is that a system of care
p.000933: under subsection (a) will provide for the case management of each child provided access to the system in
p.000933: order to ensure that—
p.000933: (A) the services provided through the system to the child are coordinated and that the need of each such child
p.000933: for the services is periodically reassessed;
p.000933: (B) information is provided to the family of the child on the extent of progress being made toward the
p.000933: objectives established for the child under the plan of services imple- mented for the child pursuant to
p.000933: section 563; and
p.000933: (C) the system provides assistance with respect to—
p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
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p.000933: (ii) to prohibit the system of care from complying with the agreement made under subsection (b); or
p.000933: (B) with respect to subparagraph (D) of such para- graph, to authorize the system of care to expend the grant
p.000933: under section 561(a) (or the non-Federal contributions made with respect to the grant) to provide
p.000933: legal services or any service with respect to which expenditures regard- ing the grant are prohibited under
p.000933: subsection (d)(1)(B).
p.000933: (f) RESTRICTIONS ON USE OF GRANT.—A funding agreement for a grant under section 561(a) is that the grant, and
p.000933: the non-Federal contributions made with respect to the grant, will not be ex- pended—
p.000933: (1) to purchase or improve real property (including the construction or renovation of facilities);
p.000933: (2) to provide for room and board in residential programs serving 10 or fewer children;
p.000933: (3) to provide for room and board or other services or ex- penditures associated with care of children in
p.000933: residential treat- ment centers serving more than 10 children or in inpatient hospital settings, except
p.000933: intensive home-based services and other services provided on an ambulatory or outpatient basis; or
p.000933: (4) to provide for the training of any individual, except
p.000933: training authorized in section 564(a)(2) and training provided through any appropriate course in continuing
p.000933: education whose duration does not exceed 2 days.
p.000933: (g) WAIVERS.—The Secretary may waive one or more of the re- quirements of subsection (c) for a public entity
p.000933: that is an Indian Tribe or tribal organization, or American Samoa, Guam, the Mar- shall Islands, the
p.000933: Federated States of Micronesia, the Common- wealth of the Northern Mariana Islands, the Republic of Palau, or the
p.000933: United States Virgin Islands if the Secretary determines, after peer review, that the system of care is family-centered
p.000933: and uses the least restrictive environment that is clinically appropriate.
p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
p.000933: (b) MULTIDISCIPLINARY TEAM.—A funding agreement for a grant under section 561(a) is that the plan
p.000933: required in subsection
p.000933: (a) will be developed, and reviewed and as appropriate revised not less than once each year, by a
p.000933: multidisciplinary team of appro- priately qualified individuals who provide services through the sys- tem,
p.000933: including as appropriate mental health services, other health
p.000933:
p.000933: January 30, 2020 As Amended Through P.L. 116-94,
p.000933: Enacted December 20, 2019
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p.000935: PUBLIC HEALTH SERVICE ACT
p.000935: Sec. 564
p.000935:
p.000935: services, educational services, social services, and vocational coun- seling and rehabilitation; 16
p.000935: (c) COORDINATION WITH SERVICES UNDER INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—A funding agreement
p.000935: for a grant under section 561(a) is that, with respect to a plan under sub- section (a) for a child,
p.000935: the multidisciplinary team required in sub- section (b) will—
p.000935: (1) in developing, carrying out, reviewing, and revising the plan consider any individualized education program
p.000935: in effect for the child pursuant to part B of the Individuals with Dis- abilities Education Act;
p.000935: (2) ensure that the plan is consistent with such individual- ized education program and provides for coordinating
p.000935: services under the plan with services under such program; and
p.000935: (3) ensure that the memorandum of understanding entered into under section 562(d)(3)(B) regarding such Act
p.000935: includes provisions regarding compliance with this subsection.
p.000935: (d) CONTENTS OF PLAN.—A funding agreement for a grant under section 561(a) is that the plan required in
p.000935: subsection (a) for a child will—
p.000935: (1) identify and state the needs of the child for the services available pursuant to section 562 through the system;
p.000935: (2) provide for each of such services that is appropriate to the circumstances of the child, including, except in the
p.000935: case of children who are less than 14 years of age, the provision of ap- propriate vocational counseling and
p.000935: rehabilitation, and transi- tion services (as defined in section 602 of the Individuals with Disabilities Education
p.000935: Act);
p.000935: (3) establish objectives to be achieved regarding the needs of the child and the methodology for achieving the
p.000935: objectives; and
p.000935: (4) designate an individual to be responsible for providing the case management required in section
p.000935: 562(e)(1) or certify that case management services will be provided to the child as part of the individualized
p.000935: education program of the child under the Individuals with Disabilities Education Act.
p.000935: SEC. 564. ø290ff–3¿ ADDITIONAL PROVISIONS.
p.000935: (a) OPTIONAL SERVICES.—In addition to services described in subsection (c) of section 562, a system of care
p.000935: under subsection (a) of such section may, in expending a grant under section 561(a), provide for—
p.000935: (1) preliminary assessments to determine whether a child should be provided access to the system;
p.000935: (2) training in—
p.000935: (A) the administration of the system;
p.000935: (B) the provision of intensive home-based services under paragraph (4) of section 562(c), intensive
p.000935: day treat- ment under paragraph (5) of such section, and foster care or group homes under paragraph (7)
p.000935: of such section; and
p.000935: (C) the development of individualized plans for pur- poses of section 563;
p.000935:
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p.000935: January 30, 2020
p.000935: 16 So in law. See section 119 of Public Law 102–321 (106 Stat. 349). Probably should be a pe- riod.
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000935: Sec. 564 PUBLIC HEALTH SERVICE ACT 936
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p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
p.000937: or adop- tive, as the case may be) and any foster parents of the child.
p.000937: (3) The term ‘‘funding agreement’’, with respect to a grant under section 561(a) to a public entity, means that
p.000937: the Sec- retary may make such a grant only if the public entity makes the agreement involved.
p.000937: (4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any child who has a
p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
p.000937:
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p.000937: January 30, 2020
p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: 939
p.000939: PUBLIC HEALTH SERVICE ACT
p.000939: Sec. 581
p.000939:
p.000939: PART F—MODEL COMPREHENSIVE PROGRAM FOR TREATMENT OF
p.000939: SUBSTANCE ABUSE 18
p.000939: PART G 19—PROJECTS FOR CHILDREN AND VIOLENCE
p.000939: SEC. 581. 19 ø290hh¿ CHILDREN AND VIOLENCE.
p.000939: (a) IN GENERAL.—The Secretary, in consultation with the Sec- retary of Education and the Attorney General, shall
p.000939: carry out di- rectly or through grants, contracts or cooperative agreements with public entities a program to assist
p.000939: local communities in developing ways to assist children in dealing with violence.
p.000939: (b) ACTIVITIES.—Under the program under subsection (a), the Secretary may—
p.000939: (1) provide financial support to enable local communities to implement programs to foster the health and
p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
...

p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000939: Sec. 582 PUBLIC HEALTH SERVICE ACT 940
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p.000939: January 30, 2020
p.000939:
p.000939: (a) will be distributed equitably among the regions of the country and among urban and rural areas.
p.000939: (e) DURATION OF AWARDS.—With respect to a grant, contract or cooperative agreement under subsection (a), the
p.000939: period during which payments under such an award will be made to the recipient may not exceed 5 years.
p.000939: (f) EVALUATION.—The Secretary shall conduct an evaluation of each project carried out under this section and
p.000939: shall disseminate the results of such evaluations to appropriate public and private entities.
p.000939: (g) INFORMATION AND EDUCATION.—The Secretary shall estab- lish comprehensive information and education
p.000939: programs to dissemi- nate the findings of the knowledge development and application under this section to
p.000939: the general public and to health care profes- sionals.
p.000939: (h) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.000939: $100,000,000 for fiscal year 2001, and such sums as may be necessary for each of fiscal years 2002 and
p.000939: 2003.
p.000939: SEC. 582. ø290hh–1¿ GRANTS TO ADDRESS THE PROBLEMS OF PER- SONS WHO EXPERIENCE VIOLENCE RELATED STRESS.
p.000939: (a) IN GENERAL.—The Secretary shall award grants, contracts or cooperative agreements to public and
p.000939: nonprofit private entities, as well as to Indian tribes and tribal organizations, for the purpose of developing and
p.000939: maintaining programs that provide for—
p.000939: (1) the continued operation of the National Child Trau- matic Stress Initiative (referred to in
p.000939: this section as the ‘‘NCTSI’’), which includes a cooperative agreement with a co- ordinating center,
p.000939: that focuses on the mental, behavioral, and biological aspects of psychological trauma response, prevention of
p.000939: the long-term consequences of child trauma, and early inter- vention services and treatment to address the
p.000939: long-term con- sequences of child trauma; and
...

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p.000949: Sec. 583 PUBLIC HEALTH SERVICE ACT 950
p.000949:
p.000949: SEC. 583. ø290kk–2¿ LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
p.000949: No funds provided under a designated program shall be ex- pended for sectarian worship, instruction, or
p.000949: proselytization.
p.000949: SEC. 584. ø290kk–3¿ EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG TREATMENT PROGRAMS.
p.000949: (a) FINDINGS.—The Congress finds that—
p.000949: (1) establishing unduly rigid or uniform educational quali- fication for counselors and other personnel in drug
p.000949: treatment programs may undermine the effectiveness of such programs; and
p.000949: (2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug
p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
...

p.000955: authority to carry out such plan in conformity with this part;
p.000955: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000957: 957
p.000957: PUBLIC HEALTH SERVICE ACT
p.000957: Sec. 604
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p.000957: January 30, 2020
p.000957: (3) provide for the designation of a State advisory council which shall include (A) representatives of
p.000957: nongovernmental or- ganizations or groups, and of public agencies, concerned with the operation,
p.000957: construction, or utilization of hospital or other facilities for diagnosis, prevention, or treatment of
p.000957: illness or disease, or for provision of rehabilitation services, and rep- resentatives particularly
p.000957: concerned with education or training of health professions personnel, and (B) an equal number of
p.000957: representatives of consumers familiar with the need for the services provided by such facilities, to
p.000957: consult with the State agency in carrying out the plan, and provide, if such council does not include any
p.000957: representatives of nongovernmental orga- nizations or groups, or State agencies, concerned with rehabili- tation, for
p.000957: consultation with organizations, groups, and State agencies so concerned;
p.000957: (4) set forth, in accordance with criteria established in reg- ulations prescribed under section 603 and on the
p.000957: basis of a statewide inventory of existing facilities, a survey of need, and (except to the extent provided by
p.000957: or pursuant to such regula- tions) community, area, or regional plans—
p.000957: (A) the number of general hospital beds and long-term care beds, and the number and types of hospital
p.000957: facilities and facilities for long-term care, needed to provide ade- quate facilities for inpatient care
p.000957: of people residing in the State, and a plan for the distribution of such beds and fa- cilities in service areas
p.000957: throughout the State;
p.000957: (B) the public health centers needed to provide ade- quate public health services for people residing in
p.000957: the State, and a plan for the distribution of such centers throughout the State;
p.000957: (C) the outpatient facilities needed to provide ade- quate diagnostic or treatment services to ambulatory
p.000957: pa- tients residing in the State, and a plan for distribution of such facilities throughout the State;
...

p.000959: of the regulations prescribed under section 603(e), and with State standards for operation and
p.000959: maintenance; and (4) that the application has been approved and recommended by the State agency, opportunity
p.000959: has been provided, prior to such approval and recommendation, for consideration of the project by the public or
p.000959: nonprofit private agency or organization which has developed
p.000959: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000959: Sec. 606 PUBLIC HEALTH SERVICE ACT 960
p.000959:
p.000959: the comprehensive regional, metropolitan area, or other local area plan or plans referred to in section
p.000959: 314(b) covering the area in which such project is to be located or, if there is no such agency or
p.000959: organization, by the State agency administering or supervising the administration of the State plan approved
p.000959: under section 314(a), and the application is for a project which is entitled to priority over other projects within
p.000959: the State in accordance with the regulations prescribed pursuant to section 603(a). Notwithstanding the
p.000959: pre- ceding sentence, the Surgeon General may approve such an appli- cation for a project for construction or
p.000959: modernization of a rehabili- tation facility only if it is also approved by the Secretary of Health, Education, and
p.000959: Welfare.
p.000959: (c) No application shall be disapproved until the Surgeon Gen- eral has afforded the State agency an opportunity for a
p.000959: hearing.
p.000959: (d) Amendment of any approved application shall be subject to approval in the same manner as an original application.
p.000959: (e) Notwithstanding any other provision of this title, no appli- cation for an outpatient facility shall
p.000959: be approved under this sec- tion unless the applicant is (1) a State, political subdivision, or public
p.000959: agency, or (2) a corporation or association which owns and operates a nonprofit hospital (as defined in
p.000959: section 645) or which provides reasonable assurance that the services of a general hos- pital will be
p.000959: available to patients of such facility who are in need of hospital care.
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p.000959: January 30, 2020
p.000959: PAYMENTS FOR CONSTRUCTION OR MODERNIZATION
p.000959: SEC. 606. ø291f¿ (a) Upon certification to the Surgeon General by the State agency, based upon inspection by
p.000959: it, that work has been performed upon a project, or purchases have been made, in accordance with the
p.000959: approved plans and specifications, and that payment of an installment is due to the applicant, such installment
...

p.000971: must meet such criteria as may be prescribed by regulations. Such regulations shall be so designed as to provide aid
p.000971: only with respect to projects for which adequate assistance is not readily available from other Federal,
p.000971: State, local, or other sources, and to assist in providing modern, efficient, and effective emergency
p.000971: room service needed to care for victims of highway, industrial, agricultural, or other acci- dents and to
p.000971: handle other medical emergencies, and to assist in providing such service in geographical areas which
p.000971: have special need therefor.
p.000971: PAYMENTS
p.000971: SEC. 633. ø291j–10¿ Grants under this part shall be paid in advance or by way of reimbursement, in such
p.000971: installments and on such conditions, as in the judgment of the Secretary will best carry out the purposes of this part.
p.000971: PART D—GENERAL
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p.000971: January 30, 2020
p.000971:
p.000971: FEDERAL HOSPITAL COUNCIL AND ADVISORY COMMITTEES
p.000971: SEC. 641. ø291k¿ (a) In administering this title, the Surgeon General shall consult with a Federal Hospital
p.000971: Council consisting of the Surgeon General, who shall serve as Chairman ex officio, and twelve members
p.000971: appointed by the Secretary of Health, Education, and Welfare. Six of the twelve appointed members shall be
p.000971: persons who are outstanding in fields pertaining to medical facility and health activities, and three of these
p.000971: six shall be authorities in mat- ters relating to the operation of hospitals or other medical facilities, one of them
p.000971: shall be an authority in matters relating to individuals with intellectual disabilities, and one of them shall be an
p.000971: authority in matters relating to mental health, and the other six members shall be appointed to represent the
p.000971: consumers of services provided by such facilities and shall be persons familiar with the need for such
p.000971: services in urban or rural areas.
p.000971: (b) Each appointed member shall hold office for a term of four years, except that any member appointed to fill a
p.000971: vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be
p.000971: appointed for the remainder of such term. An appointed member shall not be eligible to serve
p.000971: continuously for more than two terms (whether beginning before or after enactment of this section) but shall be
p.000971: eligible for reappointment if he has not served immediately preceding his reappointment.
p.000971: (c) The Council shall meet as frequently as the Surgeon Gen- eral deems necessary, but not less than
p.000971: once each year. Upon re- quest by three or more members, it shall be the duty of the Sur- geon General
p.000971: to call a meeting of the Council.
p.000971: (d) The Council is authorized to appoint such special advisory or technical committees as may be useful
...

p.000973: during such fiscal year and the method for determining the actual Federal share to be paid with respect to
p.000973: such projects; and such maximum Federal share and such method of determination for projects in such State
p.000973: approved during such fiscal year shall not be changed after such approval.
p.000973: (4) Notwithstanding the provisions of paragraphs (2) and (3) of this subsection, the Federal share shall, at the option
p.000973: of the State agency, be equal to the per centum provided under such para- graphs plus an incentive per
p.000973: centum (which when combined with the per centum provided under such paragraphs shall not exceed
p.000973: 90 per centum) specified by the State agency in the case of (A) projects that will provide services
p.000973: primarily for persons in an area determined by the Secretary to be a rural or urban poverty area, and (B)
p.000973: projects that offer potential for reducing health care costs through shared services among health care
p.000973: facilities, through inter- facility cooperation, or through the construction or modernization of free-standing
p.000973: outpatient facilities.
p.000973: (c) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related
p.000973: facilities, such as laboratories, outpatient departments, nurses’ home facilities, extended care fa- cilities,
p.000973: facilities related to programs for home health services, self- care units, and central service facilities,
p.000973: operated in connection with hospitals, and also includes education or training facilities for health professions
p.000973: personnel operated as an integral part of a hos- pital, but does not include any hospital furnishing primarily domi-
p.000973: ciliary care.
p.000973: (d) The term ‘‘public health center’’ means a publicly owned fa- cility for the provision of public health
p.000973: services, including related publicly owned facilities such as laboratories, clinics, and adminis- trative offices
p.000973: operated in connection with such a facility.
p.000973: (e) The term ‘‘nonprofit’’ as applied to any facility means a fa- cility which is owned and operated by one or
p.000973: more nonprofit cor- porations or associations no part of the net earnings of which in- ures, or may
p.000973: lawfully inure, to the benefit of any private share- holder or individual.
p.000973: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000975: PUBLIC HEALTH SERVICE ACT
p.000975: Sec. 645
p.000975:
p.000975: (f) The term ‘‘outpatient facility’’ means a facility (located in or apart from a hospital) for the diagnosis or
p.000975: diagnosis and treatment of ambulatory patients (including ambulatory inpatients)—
p.000975: (1) which is operated in connection with a hospital, or
p.000975: (2) in which patient care is under the professional super- vision of persons licensed to practice medicine or
p.000975: surgery in the State, or in the case of dental diagnosis or treatment, under the professional supervision of
p.000975: persons licensed to practice den- tistry in the State; or
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p.000975:
p.000975: (k) The term ‘‘modernization’’ includes alteration, major repair (to the extent permitted by regulations),
p.000975: remodeling, replacement, and renovation of existing buildings (including initial equipment thereof), and
p.000975: replacement of obsolete, built-in (as determined in ac- cordance with regulations) equipment of existing buildings.
p.000975: (l) The term ‘‘title,’’ when used with reference to a site for a project, means a fee simple, or such other
p.000975: estate or interest (includ- ing a leasehold on which the rental does not exceed 4 per centum of the value
p.000975: of the land) as the Surgeon General finds sufficient to assure for a period of not less than fifty years’ undisturbed
p.000975: use and possession for the purposes of construction and operation of the project.
p.000975:
p.000975: FINANCIAL STATEMENTS
p.000975: SEC. 646. ø291o–1¿ In the case of any facility for which a grant, loan, or loan guarantee has been made
p.000975: under this title, the applicant for such grant, loan, or loan guarantee (or, if appropriate, such other person as the
p.000975: Secretary may prescribe) shall file at least annually with the State agency for the State in which the
p.000975: facility is located a statement which shall be in such form, and contain such information, as the
p.000975: Secretary may require to accurately show—
p.000975: (1) the financial operations of the facility, and
p.000975: (2) the costs to the facility of providing health services in the facility and the charges made by the
p.000975: facility for providing such services,
p.000975: during the period with respect to which the statement is filed.
p.000975:
p.000975: TITLE VII—HEALTH PROFESSIONS EDUCATION
p.000975: PART A—STUDENT LOANS
p.000975: Subpart I—Insured Health Education Assistance Loans to Graduate Students
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p.000975: January 30, 2020
p.000975: SEC. 701. ø292¿ STATEMENT OF PURPOSE.
p.000975: The purpose of this subpart is to enable the Secretary to pro- vide a Federal program of student loan
p.000975: insurance for students in (and certain former students of) eligible institutions (as defined in section
p.000975: 719).
p.000975: SEC. 702. ø292a¿ SCOPE AND DURATION OF LOAN INSURANCE PRO- GRAM.
p.000975: (a) IN GENERAL.—The total principal amount of new loans made and installments paid pursuant to lines of credit
p.000975: (as defined in section 719) to borrowers covered by Federal loan insurance under this subpart shall not
p.000975: exceed $350,000,000 for fiscal year 1993, $375,000,000 for fiscal year 1994, and $425,000,000 for fiscal year 1995.
p.000975: If the total amount of new loans made and installments paid pursuant to lines of credit in any fiscal year is
p.000975: less than the ceiling established for such year, the difference between the loans made and installments
p.000975: paid and the ceiling shall be carried over
p.000975: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000977: 977
p.000977: PUBLIC HEALTH SERVICE ACT
p.000977: Sec. 702
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p.000977: be grant- ed by the Secretary without regard to any apportionment for the purpose of chapter 15 of title 31,
p.000977: United States Code, and without regard to any similar limitation.
p.000977: (b) CERTAIN LIMITATIONS AND PRIORITIES.—
p.000977: (1) LIMITATIONS REGARDING LENDERS, STATES, OR AREAS.— The Secretary may, if necessary to assure an equitable
p.000977: dis- tribution of the benefits of this subpart, assign, within the maximum amounts specified in subsection
p.000977: (a), Federal loan in- surance quotas applicable to eligible lenders, or to States or areas, and may from time
p.000977: to time reassign unused portions of these quotas.
p.000977: (2) PRIORITY FOR CERTAIN LENDERS.—In providing certifi- cates of insurance under section 706 through
p.000977: comprehensive contracts, the Secretary shall give priority to eligible lenders that agree—
p.000977: (A) to make loans to students at interest rates below the rates prevailing, during the period involved,
p.000977: for loans covered by Federal loan insurance pursuant to this sub- part; or
p.000977: (B) to make such loans under terms that are otherwise favorable to the student relative to the terms under which
p.000977: eligible lenders are generally making such loans during such period.
p.000977: (c) AUTHORITY OF STUDENT LOAN MARKETING ASSOCIATION.—
p.000977: (1) IN GENERAL.—Subject to paragraph (2), the Student Loan Marketing Association, established under part B
p.000977: of title IV of the Higher Education Act of 1965, is authorized to make advances on the security of, purchase,
p.000977: service, sell, consolidate, or otherwise deal in loans which are insured by the Secretary under this
p.000977: subpart, except that if any loan made under this subpart is included in a consolidated loan pursuant to the au-
p.000977: thority of the Association under part B of title IV of the Higher Education Act of 1965, the interest rate on
p.000977: such consolidated loan shall be set at the weighted average interest rate of all such loans offered for
p.000977: consolidation and the resultant per cen- tum shall be rounded downward to the nearest one-eighth of
p.000977: 1 per centum, except that the interest rate shall be no less than the applicable interest rate of the
p.000977: guaranteed student loan program established under part B of title IV of the Higher Education Act of 1965. In the case
p.000977: of such a consolidated loan, the borrower shall be responsible for any interest which ac-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000977: Sec. 703 PUBLIC HEALTH SERVICE ACT 978
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p.000977: crues prior to the beginning of the repayment period of the loan, or which accrues during a period in which
p.000977: principal need not be paid (whether or not such principal is in fact paid) by reason of any provision
p.000977: of the Higher Education Act of 1965.
p.000977: (2) APPLICABILITY OF CERTAIN FEDERAL REGULATIONS.— With respect to Federal regulations for lenders,
p.000977: this subpart may not be construed to preclude the applicability of such reg- ulations to the Student Loan
p.000977: Marketing Association or to any other entity in the business of purchasing student loans, in- cluding such
p.000977: regulations with respect to applications, contracts, and due diligence.
p.000977: SEC. 703. ø292b¿ LIMITATIONS ON INDIVIDUAL INSURED LOANS AND ON LOAN INSURANCE.
p.000977: (a) IN GENERAL.—The total of the loans made to a student in any academic year or its equivalent (as
p.000977: determined by the Sec- retary) which may be covered by Federal loan insurance under this subpart may not exceed
p.000977: $20,000 in the case of a student enrolled in a school of medicine, osteopathic medicine, dentistry, veterinary
p.000977: medicine, optometry, or podiatric medicine, and $12,500 in the case of a student enrolled in a school of pharmacy,
p.000977: public health, allied health, or chiropractic, or a graduate program in health adminis- tration or behavioral
p.000977: and mental health practice, including clinical psychology. The aggregate insured unpaid principal amount for all such
p.000977: insured loans made to any borrower shall not at any time ex- ceed $80,000 in the case of a borrower who is or was a
p.000977: student en- rolled in a school of medicine, osteopathic medicine, dentistry, vet- erinary medicine, optometry, or
...

p.000983: obligation evidenced by a single instrument of indebted- ness or the refinancing of a single loan shall
p.000983: not affect the insur- ance by the United States. If the loans thus consolidated are cov- ered by
p.000983: separate certificates of insurance issued under subsection (a), the Secretary may upon surrender of the
p.000983: original certificates issue a new certificate of insurance in accordance with that sub- section upon the
p.000983: consolidated obligation. If the loans thus consoli- dated are covered by a single comprehensive
p.000983: certificate issued under subsection (b), the Secretary may amend that certificate ac- cordingly.
p.000983: (e) RULE OF CONSTRUCTION REGARDING CONSOLIDATION OF DEBTS AND REFINANCING.—Nothing in this section
p.000983: shall be con- strued to preclude the lender and the borrower, by mutual agree- ment, from consolidating
p.000983: all of the borrower’s loans insured under this subpart into a single instrument (or, if the borrower
p.000983: obtained only 1 loan insured under this subpart, refinancing the loan 1 time) under the terms applicable to an
p.000983: insured loan made at the same time as the consolidation. The lender or loan holder should provide full information
p.000983: to the borrower concerning the advantages and dis- advantages of loan consolidation or refinancing. Nothing in
p.000983: this section shall be construed to preclude the consolidation of the bor- rower’s loans insured under this subpart
p.000983: under section 428C of the Higher Education Act of 1965. Any loans insured pursuant to this subpart that are
p.000983: consolidated under section 428C of such Act shall not be eligible for special allowance payments under section 438 of
p.000983: such Act.
p.000983: SEC. 707. ø292f¿ DEFAULT OF BORROWER.
p.000983: (a) CONDITIONS FOR PAYMENT TO BENEFICIARY.—
p.000983: (1) IN GENERAL.—Upon default by the borrower on any loan covered by Federal loan insurance pursuant to
p.000983: this sub- part, and after a substantial collection effort (including, subject to subsection (h), commencement and
p.000983: prosecution of an action) as determined under regulations of the Secretary, the insur- ance beneficiary shall
p.000983: promptly notify the Secretary and the Secretary shall, if requested (at that time or after further col-
p.000983: lection efforts) by the beneficiary, or may on his own motion, if the insurance is still in effect,
p.000983: pay to the beneficiary the
p.000983: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000985: PUBLIC HEALTH SERVICE ACT
p.000985: Sec. 707
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p.000989: of the loan.
p.000989: (B) DEFAULT MANAGEMENT PLAN.—An institution of the type described in subparagraph (A) shall prepare
p.000989: and submit to the Secretary for approval a plan that meets the requirements of paragraph (2)(B).
p.000989: (4) INELIGIBILITY.—An individual shall not be eligible to obtain a loan under this subpart for attendance
p.000989: at an institu- tion that has a default rate in excess of 20 percent.
p.000989: (c) REDUCTION OF RISK-BASED PREMIUM.—Lenders shall reduce by 50 percent the risk-based premium to
p.000989: eligible borrowers if a credit worthy parent or other responsible party co-signs the loan note.
p.000989: (d) ADMINISTRATIVE WAIVERS.—
p.000989: (1) HEARING.—The Secretary shall afford an institution not less than one hearing, and may consider
p.000989: mitigating cir- cumstances, prior to making such institution ineligible for par- ticipation in the program under this
p.000989: subpart.
p.000989: (2) EXCEPTIONS.—In carrying out this section with respect to an institution, the Secretary may grant an
p.000989: institution a waiver of requirements of paragraphs (2) through (4) of sub- section (b) if the Secretary
p.000989: determines that the default rate for such institution is not an accurate indicator because the vol- ume of
p.000989: the loans under this subpart made by such institution has been insufficient.
p.000989: (3) TRANSITION FOR CERTAIN INSTITUTIONS.—During the 3- year period beginning on the effective date of the
p.000989: Health Pro- fessions Education Extension Amendments of 1992—
p.000989: (A) subsection (b)(4) shall not apply with respect to any eligible institution that is a Historically Black
p.000989: College or University; and
p.000989: (B) any such institution that has a default rate in ex- cess of 20 percent, and any eligible borrower seeking
p.000989: a loan for attendance at the institution, shall be subject to subsection (b)(3) to the same extent and in the
p.000989: same man- ner as eligible institutions and borrowers described in such subsection.
p.000989: (e) PAYOFF TO REDUCE RISK CATEGORY.—An institution may pay off the outstanding principal and interest
p.000989: owed by the bor- rowers of such institution who have defaulted on loans made under this subpart in order to reduce
p.000989: the risk category of the institution.
p.000989: SEC. 709. ø292h¿ OFFICE FOR HEALTH EDUCATION ASSISTANCE LOAN DEFAULT REDUCTION.
p.000989: (a) ESTABLISHMENT.—The Secretary shall establish, within the Division of Student Assistance of the Bureau of Health
p.000989: Professions, an office to be known as the Office for Health Education Assistance Loan Default Reduction (in this
p.000989: section referred to as the ‘‘Office’’).
p.000989: (b) PURPOSE AND FUNCTIONS.—It shall be the purpose of the Office to achieve a reduction in the number
p.000989: and amounts of de- faults on loans guaranteed under this subpart. In carrying out such purpose the Office shall—
p.000989: (1) conduct analytical and evaluative studies concerning loans and loan defaults;
p.000989: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000991: 991
p.000991: PUBLIC HEALTH SERVICE ACT
p.000991: Sec. 710
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p.000991: (2) carry out activities designed to reduce loan defaults;
p.000991: (3) respond to special circumstances that may exist in the financial lending environment that may lead to loan
p.000991: defaults;
p.000991: (4) coordinate with other Federal entities that are involved with student loan programs, including—
p.000991: (A) with respect to the Department of Education, in the development of a single student loan application form,
p.000991: a single student loan deferment form, a single disability form, and a central student loan database; and
p.000991: (B) with respect to the Department of Justice, in the recovery of payments from health professionals who
p.000991: have defaulted on loans guaranteed under this subpart; and
p.000991: (5) provide technical assistance to borrowers, lenders, hold- ers, and institutions concerning deferments and
p.000991: collection ac- tivities.
p.000991: (c) ADDITIONAL DUTIES.—In conjunction with the report sub- mitted under subsection (b), the Office shall—
p.000991: (1) compile, and publish in the Federal Register, a list of the borrowers who are in default under this
p.000991: subpart; and
p.000991: (2) send the report and notices of default with respect to these borrowers to relevant Federal agencies
p.000991: and to schools, school associations, professional and specialty associations, State licensing boards,
p.000991: hospitals with which such borrowers may be associated, and any other relevant organizations.
p.000991: (d) ALLOCATION OF FUNDS FOR OFFICE.—In the case of amounts reserved under section 710(a)(2)(B)
p.000991: for obligation under this subsection, the Secretary may obligate the amounts for the purpose of
...

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p.000993: PUBLIC HEALTH SERVICE ACT
p.000993: Sec. 715
p.000993:
p.000993: (5) To enforce, pay, compromise, waive, or release any right, title, claim, lien, or demand, however acquired,
p.000993: including any equity or any right or 2 redemption.
p.000993: (b) ANNUAL BUDGET; ACCOUNTS.—The Secretary shall, with re- spect to the financial operations arising by reason of this
p.000993: subpart—
p.000993: (1) prepare annually and submit a budget program as pro- vided for wholly owned Government corporations by the
p.000993: Gov- ernment Corporation Control Act; and
p.000993: (2) maintain with respect to insurance under this subpart an integral set of accounts.
p.000993: SEC. 712. ø292k¿ PARTICIPATION BY FEDERAL CREDIT UNIONS IN FED- ERAL, STATE, AND PRIVATE STUDENT LOAN INSURANCE
p.000993: PROGRAMS.
p.000993: Notwithstanding any other provision of law, Federal credit unions shall, pursuant to regulations of the
p.000993: Administrator of the National Credit Union Administration, have power to make in- sured loans to eligible
p.000993: students in accordance with the provisions of this subpart relating to Federal insured loans.
p.000993: SEC. 713. ø292l¿ DETERMINATION OF ELIGIBLE STUDENTS.
p.000993: For purposes of determining eligible students under this part, in the case of a public school in a State that
p.000993: offers an accelerated, integrated program of study combining undergraduate premedical education and medical
p.000993: education leading to advanced entry, by con- tractual agreement, into an accredited four-year school of medicine which
p.000993: provides the remaining training leading to a degree of doctor of medicine, whenever in this part a provision
p.000993: refers to a student at a school of medicine, such reference shall include only a student enrolled in any of the last
p.000993: four years of such accelerated, integrated program of study.
p.000993: SEC. 714. ø292m¿ REPAYMENT BY SECRETARY OF LOANS OF DECEASED OR DISABLED BORROWERS.
p.000993: If a borrower who has received a loan dies or becomes perma- nently and totally disabled (as determined in accordance
p.000993: with regu- lations of the Secretary), the Secretary shall discharge the bor- rower’s liability on the loan
p.000993: by repaying the amount owed on the loan from the account established under section 710.
p.000993: SEC. 715. ø292n¿ ADDITIONAL REQUIREMENTS FOR INSTITUTIONS AND LENDERS.
p.000993: (a) IN GENERAL.—Notwithstanding any other provision of this subpart, the Secretary is authorized to
p.000993: prescribe such regulations as may be necessary to provide for—
p.000993: (1) a fiscal audit of an eligible institution with regard to any funds obtained from a borrower who
p.000993: has received a loan insured under this subpart;
p.000993: (2) the establishment of reasonable standards of financial responsibility and appropriate institutional
p.000993: capability for the administration by an eligible institution of a program of stu- dent financial aid with
p.000993: respect to funds obtained from a stu- dent who has received a loan insured under this subpart;
p.000993:
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p.000993: January 30, 2020
p.000993: 2 So in law. See section 102 of Public Law 102–408 (106 Stat. 1994). Probably should be ‘‘right of redemption’’.
p.000993: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000993: Sec. 719 PUBLIC HEALTH SERVICE ACT 994
p.000993:
p.000993: (3) the limitation, suspension, or termination of the eligi- bility under this subpart of any otherwise
p.000993: eligible institution, whenever the Secretary has determined, after notice and af- fording an opportunity
p.000993: for hearing, that such institution has violated or failed to carry out any regulation prescribed under this
p.000993: subpart;
p.000993: (4) the collection of information from the borrower, lender, or eligible institution to assure compliance with the
p.000993: provisions of section 705;
p.000993: (5) the assessing of tuition or fees to borrowers in amounts that are the same or less than the amount of
p.000993: tuition and fees assessed to nonborrowers;
p.000993: (6) the submission, by the institution or the lender to the Office of Health Education Assistance Loan
p.000993: Default Reduction, of information concerning each loan made under this subpart, including the date when
p.000993: each such loan was originated, the date when each such loan is sold, the identity of the loan hold- er and
p.000993: information concerning a change in the borrower’s sta- tus;
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p.000993: (7) the withholding of services, including academic tran- scripts, financial aid transcripts, and alumni
p.000993: services, by an in- stitution from a borrower upon the default of such borrower of a loan under this subpart, except in
p.000993: case of a borrower who has filed for bankruptcy; and
p.000993: (8) the offering, by the lender to the borrower, of a variety of repayment options, including fixed-rate,
p.000993: graduated repay- ment with negative amortization permitted, and income de- pendent payments for a limited
p.000993: period followed by level month- ly payments.
p.000993: (b) RECORDING BY INSTITUTION OF INFORMATION ON STU- DENTS.—The Secretary shall require an
p.000993: eligible institution to record, and make available to the lender and to the Secretary upon request, the name,
p.000993: address, postgraduate destination, and other reasonable identifying information for each student of such institu-
p.000993: tion who has a loan insured under this subpart.
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p.001005: the Federal capital contribution, will be utilized only for the purpose of—
p.001005: (A) making loans to individuals from disadvantaged backgrounds; and
p.001005: (B) the costs of the collection of the loans and interest on the loans; and
p.001005: (2) collections of principal and interest on loans made pur- suant to paragraph (1), and any other earnings of the
p.001005: student loan fund attributable to amounts that are in the fund pursu- ant to such paragraph, will be utilized only for
p.001005: the purpose de- scribed in such paragraph.
p.001005: (b) MINIMUM QUALIFICATIONS FOR SCHOOLS.—The Secretary may not make a Federal capital contribution for
p.001005: purposes of sub- section (a) for a fiscal year unless the health professions school in- volved—
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p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
p.001005: (2) with respect to health clinics providing services to a significant number of individuals who are
p.001005: from disadvantaged backgrounds, including members of minority groups, to enter into arrangements with 1 or more
p.001005: such clinics for the purpose of providing students of the school with experience in providing clinical services to such
p.001005: individuals;
p.001005: (3) with respect to public or nonprofit private secondary educational institutions and undergraduate
p.001005: institutions of higher education, to enter into arrangements with 1 or more such institutions for the
p.001005: purpose of carrying out programs re- garding the educational preparation of disadvantaged students, including
p.001005: minority students, to enter the health professions and regarding the recruitment of such individuals into
p.001005: the health professions;
p.001005: (4) to establish a mentor program for assisting disadvan- taged students, including minority students,
p.001005: regarding the completion of the educational requirements for degrees from the school;
p.001005: (5) to be carrying out each of the activities specified in any of paragraphs (1) through (4) by not later than 1 year
p.001005: after the date on which the first Federal capital contribution is made to the school for purposes of subsection (a);
p.001005: and
p.001005: (6) to continue carrying out such activities, and the activi- ties specified in paragraphs (1) and (2) of
p.001005: subsection (b),
p.001005: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001009: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making Federal capital contributions to student
p.001009: loan funds established under section 721 by schools of medicine or osteo- pathic medicine, there is
p.001009: authorized to be appropriated
p.001009: $10,000,000 for each of the fiscal years 1994 through 1996.
p.001009: (2) MINIMUM REQUIREMENTS.—
p.001009: (A) Subject to subparagraph (B), the Secretary may make a Federal capital contribution pursuant to paragraph
p.001009: (1) only if the school of medicine or osteopathic medicine involved meets the conditions described in
p.001009: subparagraph
p.001009: (A) of section 723(b)(2) or the conditions described in sub- paragraph (C) of such section.
p.001009: (B) For purposes of subparagraph (A), the conditions referred to in such subparagraph shall be applied with re-
p.001009: spect to graduates of the school involved whose date of graduation occurred approximately 3 years before June
p.001009: 30 of the fiscal year preceding the fiscal year for which the Federal capital contribution involved is made.
p.001009:
p.001009: PART B—HEALTH PROFESSIONS TRAINING FOR DIVERSITY
p.001009: SEC. 736. ø293¿ CENTERS OF EXCELLENCE.
p.001009: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, designated health
p.001009: professions schools de- scribed in subsection (c), and other public and nonprofit health or educational
p.001009: entities, for the purpose of assisting the schools in sup- porting programs of excellence in health professions
p.001009: education for under-represented minority individuals.
p.001009: (b) REQUIRED USE OF FUNDS.—The Secretary may not make a grant under subsection (a) unless the designated health
p.001009: professions school involved agrees, subject to subsection (c)(1)(C), to expend the grant—
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p.001009: January 30, 2020
p.001009: (1) to develop a large competitive applicant pool through linkages with institutions of higher education, local
p.001009: school dis- tricts, and other community-based entities and establish an education pipeline for health
p.001009: professions careers;
p.001009: (2) to establish, strengthen, or expand programs to en- hance the academic performance of under-represented
p.001009: minority students attending the school;
p.001009: (3) to improve the capacity of such school to train, recruit, and retain under-represented minority faculty
p.001009: including the payment of such stipends and fellowships as the Secretary may determine appropriate;
p.001009: (4) to carry out activities to improve the information re- sources, clinical education, curricula and
p.001009: cultural competence of the graduates of the school, as it relates to minority health issues;
p.001009: (5) to facilitate faculty and student research on health issues particularly affecting
p.001009: under-represented minority groups, including research on issues relating to the delivery of health care;
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001009: Sec. 736 PUBLIC HEALTH SERVICE ACT 1010
p.001009:
p.001009: (6) to carry out a program to train students of the school in providing health services to a
p.001009: significant number of under- represented minority individuals through training provided to such students at
p.001009: community-based health facilities that—
p.001009: (A) provide such health services; and
p.001009: (B) are located at a site remote from the main site of the teaching facilities of the school; and
p.001009: (7) to provide stipends as the Secretary determines appro- priate, in amounts as the Secretary determines appropriate.
p.001009: (c) CENTERS OF EXCELLENCE.—
p.001009: (1) DESIGNATED SCHOOLS.—
p.001009: (A) IN GENERAL.—The designated health professions schools referred to in subsection (a) are such schools
p.001009: that meet each of the conditions specified in subparagraphs (B) and (C), and that—
p.001009: (i) meet each of the conditions specified in para- graph (2)(A);
p.001009: (ii) meet each of the conditions specified in para- graph (3);
p.001009: (iii) meet each of the conditions specified in para- graph (4); or
p.001009: (iv) meet each of the conditions specified in para- graph (5).
p.001009: (B) GENERAL CONDITIONS.—The conditions specified in this subparagraph are that a designated health professions school—
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p.001009: (i) has a significant number of under-represented minority individuals enrolled in the school, including
p.001009: individuals accepted for enrollment in the school;
p.001009: (ii) has been effective in assisting under-rep- resented minority students of the school to complete
p.001009: the program of education and receive the degree in- volved;
p.001009: (iii) has been effective in recruiting under-rep- resented minority individuals to enroll in and grad-
p.001009: uate from the school, including providing scholarships and other financial assistance to such individuals and
p.001009: encouraging under-represented minority students from all levels of the educational pipeline to pursue health
p.001009: professions careers; and
p.001009: (iv) has made significant recruitment efforts to in- crease the number of under-represented minority indi- viduals
p.001009: serving in faculty or administrative positions at the school.
p.001009: (C) CONSORTIUM.—The condition specified in this sub- paragraph is that, in accordance with subsection (e)(1), the
p.001009: designated health profession school involved has with other health profession schools (designated or
p.001009: otherwise) formed a consortium to carry out the purposes described in subsection (b) at the schools of the consortium.
p.001009: (D) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Secretary
p.001009: for purposes of determining whether schools meet the condi- tions described in subparagraph (B), this section
p.001009: may not,
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
p.001011: (A) CONDITIONS.—The conditions specified in this sub- paragraph are that a designated health professions
p.001011: school—
p.001011: (i) is a school described in section 799B(1); and
p.001011: (ii) received a contract under section 788B for fis- cal year 1987, as such section was in effect for such
p.001011: fiscal year.
p.001011: (B) USE OF GRANT.—In addition to the purposes de- scribed in subsection (b), a grant under subsection
p.001011: (a) to a designated health professions school meeting the condi- tions described in subparagraph (A) may be
p.001011: expended—
p.001011: (i) to develop a plan to achieve institutional im- provements, including financial independence, to en-
p.001011: able the school to support programs of excellence in health professions education for under-represented mi-
p.001011: nority individuals; and
p.001011: (ii) to provide improved access to the library and informational resources of the school.
p.001011: (C) EXCEPTION.—The requirements of paragraph (1)(C) shall not apply to a historically black college or university that
p.001011: receives funding under paragraphs (2) or (5) 7.
p.001011: (3) HISPANIC CENTERS OF EXCELLENCE.—The conditions specified in this paragraph are that—
p.001011: (A) with respect to Hispanic individuals, each of clauses (i) through (iv) of paragraph (1)(B)
p.001011: applies to the designated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Hispanic individ- uals; and
p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit community based His- panic serving organizations, or public or nonprofit pri-
p.001011: vate institutions of higher education, including schools of nursing, whose enrollment of students has tradi-
p.001011: tionally included a significant number of Hispanic in- dividuals, the purposes of which will be to carry out a
p.001011: program—
p.001011: (I) to identify Hispanic students who are in- terested in a career in the health profession in- volved;
p.001011: and
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p.001011: January 30, 2020
p.001011: 7 So in law. Probably should read ‘‘paragraph (2) or (5)’’.
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011:
p.001011: (II) to facilitate the educational preparation of such students to enter the health professions school; and
p.001011: (ii) the school will make efforts to recruit Hispanic students, including students who have participated in the
p.001011: undergraduate or other matriculation program carried out under arrangements established by the school
p.001011: pursuant to clause (i)(II) and will assist His- panic students regarding the completion of the edu-
p.001011: cational requirements for a degree from the school.
p.001011: (4) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Subject to subsection (e), the conditions specified in this
p.001011: paragraph are that—
p.001011: (A) with respect to Native Americans, each of clauses
p.001011: (i) through (iv) of paragraph (1)(B) applies to the des- ignated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Native Americans; and
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p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit private institutions of higher education, including schools of nursing,
p.001011: whose enrollment of students has traditionally included a significant number of Native Americans, the
p.001011: purpose of which arrangement will be to carry out a program—
p.001011: (I) to identify Native American students, from the institutions of higher education referred to in clause (i),
p.001011: who are interested in health professions careers; and
p.001011: (II) to facilitate the educational preparation of such students to enter the designated health pro- fessions
p.001011: school; and
p.001011: (ii) the designated health professions school will make efforts to recruit Native American students, in-
p.001011: cluding students who have participated in the under- graduate program carried out under arrangements es-
p.001011: tablished by the school pursuant to clause (i) and will assist Native American students regarding the comple- tion of
p.001011: the educational requirements for a degree from the designated health professions school.
p.001011: (5) OTHER CENTERS OF EXCELLENCE.—The conditions speci- fied in this paragraph are—
p.001011: (A) with respect to other centers of excellence, the con- ditions described in clauses (i) through (iv) of
p.001011: paragraph (1)(B); and
p.001011: (B) that the health professions school involved has an enrollment of under-represented minorities above the na-
p.001011: tional average for such enrollments of health professions schools.
p.001011: (d) DESIGNATION AS CENTER OF EXCELLENCE.—
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001013: 1013
p.001013: PUBLIC HEALTH SERVICE ACT
p.001013: Sec. 736
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p.001013: (1) IN GENERAL.—Any designated health professions school receiving a grant under subsection (a) and meeting the
p.001013: condi- tions described in paragraph (2) or (5) of subsection (c) shall, for purposes of this section, be
p.001013: designated by the Secretary as a Center of Excellence in Under-Represented Minority Health Professions
p.001013: Education.
p.001013: (2) HISPANIC CENTERS OF EXCELLENCE.—Any designated health professions school receiving a grant under subsection
p.001013: (a) and meeting the conditions described in subsection (c)(3) shall, for purposes of this section, be designated by the
p.001013: Secretary as a Hispanic Center of Excellence in Health Professions Edu- cation.
p.001013: (3) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Any des- ignated health professions school receiving a grant under
p.001013: sub- section (a) and meeting the conditions described in subsection (c)(4) shall, for purposes of this
p.001013: section, be designated by the Secretary as a Native American Center of Excellence in Health Professions Education.
p.001013: Any consortium receiving such a grant pursuant to subsection (e) shall, for purposes of this section, be so
p.001013: designated.
p.001013: (e) AUTHORITY REGARDING NATIVE AMERICAN CENTERS OF EX- CELLENCE.—With respect to meeting the conditions
p.001013: specified in subsection (c)(4), the Secretary may make a grant under subsection
p.001013: (a) to a designated health professions school that does not meet such conditions if—
p.001013: (1) the school has formed a consortium in accordance with subsection (d)(1); and
p.001013: (2) the schools of the consortium collectively meet such conditions, without regard to whether the
p.001013: schools individually meet such conditions.
p.001013: (f) DURATION OF GRANT.—The period during which payments are made under a grant under subsection (a) may
p.001013: not exceed 5 years. Such payments shall be subject to annual approval by the Secretary and to the
p.001013: availability of appropriations for the fiscal year involved to make the payments.
p.001013: (g) DEFINITIONS.—In this section:
p.001013: (1) DESIGNATED HEALTH PROFESSIONS SCHOOL.—
p.001013: (A) IN GENERAL.—The term ‘‘health professions school’’ means, except as provided in subparagraph (B), a school of
p.001013: medicine, a school of osteopathic medicine, a school of den- tistry, a school of pharmacy, or a graduate program in be-
p.001013: havioral or mental health.
p.001013: (B) EXCEPTION.—The definition established in sub- paragraph (A) shall not apply to the use of the term ‘‘des-
p.001013: ignated health professions school’’ for purposes of sub- section (c)(2).
p.001013: (2) PROGRAM OF EXCELLENCE.—The term ‘‘program of ex- cellence’’ means any program carried out by a
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p.001015: $30,000 of the principal and interest of the educational loans of such individuals.
p.001015: (2) ELIGIBLE INDIVIDUALS.—The individuals referred to in paragraph (1) are individuals from disadvantaged
p.001015: backgrounds who—
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p.001017: PUBLIC HEALTH SERVICE ACT
p.001017: Sec. 738
p.001017:
p.001017: (A) have a degree in medicine, osteopathic medicine, dentistry, nursing, or another health profession;
p.001017: (B) are enrolled in an approved graduate training pro- gram in medicine, osteopathic medicine, dentistry, nursing, or
p.001017: other health profession; or
p.001017: (C) are enrolled as full-time students—
p.001017: (i) in an accredited (as determined by the Sec- retary) school described in paragraph (3); and
p.001017: (ii) in the final year of a course of a study or pro- gram, offered by such institution and approved by the Secretary,
p.001017: leading to a degree from such a school.
p.001017: (3) ELIGIBLE HEALTH PROFESSIONS SCHOOLS.—The schools described in this paragraph are schools of medicine,
p.001017: nursing (as schools of nursing are defined in section 801), osteopathic medicine, dentistry, pharmacy,
p.001017: allied health, podiatric medi- cine, optometry, veterinary medicine, or public health, schools offering
p.001017: physician assistant education programs, or schools of- fering graduate programs in behavioral and mental health.
p.001017: (4) REQUIREMENTS REGARDING FACULTY POSITIONS.—The Secretary may not enter into a contract under
p.001017: paragraph (1) unless—
p.001017:
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p.001017: (A) the individual involved has entered into a contract with a school described in paragraph (3) to serve as
p.001017: a member of the faculty of the school for not less than 2 years; and
p.001017: (B) the contract referred to in subparagraph (A) pro- vides that—
p.001017: (i) the school will, for each year for which the indi- vidual will serve as a member of the faculty under the contract
p.001017: with the school, make payments of the prin- cipal and interest due on the educational loans of the
p.001017: individual for such year in an amount equal to the amount of such payments made by the Secretary for
p.001017: the year;
p.001017: (ii) the payments made by the school pursuant to clause (i) on behalf of the individual will be in addition to
p.001017: the pay that the individual would otherwise receive for serving as a member of such faculty; and
p.001017: (iii) the school, in making a determination of the amount of compensation to be provided by the school
p.001017: to the individual for serving as a member of the fac- ulty, will make the determination without regard
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p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
p.001019: (B) facilitating the entry of such individuals into such a school;
p.001019: (C) providing counseling, mentoring, or other services designed to assist such individuals to complete
p.001019: successfully their education at such a school;
p.001019: (D) providing, for a period prior to the entry of such individuals into the regular course of education
p.001019: of such a school, preliminary education and health research training designed to assist them to complete
p.001019: successfully such reg- ular course of education at such a school, or referring such individuals to institutions
p.001019: providing such preliminary edu- cation;
p.001019: (E) publicizing existing sources of financial aid avail- able to students in the education program of such a
p.001019: school or who are undertaking training necessary to qualify them to enroll in such a program;
p.001019: (F) paying such scholarships as the Secretary may de- termine for such individuals for any period of health
p.001019: pro- fessions education at a health professions school;
p.001019: (G) paying such stipends as the Secretary may ap- prove for such individuals for any period of
p.001019: education in
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001019: student-enhancement programs (other than regular courses), except that such a stipend may not be
p.001019: provided to an individual for more than 12 months, and such a sti- pend shall be in an amount determined appropriate by
p.001019: the Secretary (notwithstanding any other provision of law re- garding the amount of stipends);
p.001019: (H) carrying out programs under which such individ- uals gain experience regarding a career in a field
p.001019: of pri- mary health care through working at facilities of public or private nonprofit community-based providers of
p.001019: primary health services; and
p.001019: (I) conducting activities to develop a larger and more competitive applicant pool through partnerships with
p.001019: insti- tutions of higher education, school districts, and other community-based entities.
p.001019: (3) DEFINITION.—In this section, the term ‘‘regular course of education of such a school’’ as used in
p.001019: subparagraph (D) in- cludes a graduate program in behavioral or mental health.
p.001019: (b) REQUIREMENTS FOR AWARDS.—In making awards to eligible entities under subsection (a)(1), the Secretary shall give
p.001019: preference to approved applications for programs that involve a comprehensive approach by several public or
p.001019: nonprofit private health or edu- cational entities to establish, enhance and expand educational pro- grams that
p.001019: will result in the development of a competitive appli- cant pool of individuals from disadvantaged
p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
p.001019: common objectives with institutions of higher education, school dis- tricts, and other community-based entities.
p.001019: (2) Such formal agreements shall reflect the coordination of educational activities and support services,
p.001019: increased link- ages, and the consolidation of resources within a specific geo- graphic area.
p.001019: (3) The design of the educational activities involved shall provide for the establishment of a
p.001019: competitive health profes- sions applicant pool of individuals from disadvantaged back- grounds by enhancing
p.001019: the total preparation (academic and so- cial) of such individuals to pursue a health professions career.
p.001019: (4) The programs or activities under the award shall focus on developing a culturally competent health care
p.001019: workforce that will serve the unserved and underserved populations within the geographic area.
p.001019: (c) EQUITABLE ALLOCATION OF FINANCIAL ASSISTANCE.—The Secretary, to the extent practicable, shall ensure that
p.001019: services and activities under subsection (a) are adequately allocated among the various racial and ethnic
p.001019: populations who are from disadvantaged backgrounds.
p.001019: (d) MATCHING REQUIREMENTS.—The Secretary may require that an entity that applies for a grant or contract
p.001019: under subsection (a), provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of
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p.001021: any fiscal year, the Secretary shall ensure that not less than 16 percent shall be distributed to schools of
p.001021: nursing.
p.001021: (b) LOAN REPAYMENTS AND FELLOWSHIPS.—For the purpose of carrying out section 738, there is authorized to
p.001021: be appropriated,
p.001021: $5,000,000 for each of the fiscal years 2010 through 2014.
p.001021: (c) EDUCATIONAL ASSISTANCE IN HEALTH PROFESSIONS REGARD- ING INDIVIDUALS FOR DISADVANTAGED BACKGROUNDS.—For
p.001021: the pur- pose of grants and contracts under section 739(a)(1), there is au- thorized to be appropriated
p.001021: $60,000,000 for fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011
p.001021: through 2014. The Secretary may use not to exceed 20 percent of the amount appropriated for a fiscal
p.001021: year under this subsection to provide scholarships under section 739(a)(2)(F).
p.001021: (d) REPORT.—Not later than 6 months after the date of enact- ment of this part, the Secretary shall
p.001021: prepare and submit to the appropriate committees of Congress a report concerning the efforts of the Secretary to
p.001021: address the need for a representative mix of in- dividuals from historically minority health professions schools,
p.001021: or from institutions or other entities that historically or by geographic location have a demonstrated record
p.001021: of training or educating underrepresented minorities, within various health professions dis- ciplines, on peer
p.001021: review councils.
p.001021: SEC. 741. ø293e¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001021: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—
p.001021: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001021: Administra- tion, may make awards of grants, contracts, or cooperative agreements to public and nonprofit
p.001021: private entities (including tribal entities) for the development, evaluation, and dissemina- tion of research,
p.001021: demonstration projects, and model curricula for cultural competency, prevention, public health proficiency,
p.001021: reducing health disparities, and aptitude for working with indi- viduals with disabilities training for use in
p.001021: health professions schools and continuing education programs, and for other pur- poses determined as appropriate by
p.001021: the Secretary.
p.001021: (2) ELIGIBLE ENTITIES.—Unless specifically required other- wise in this title, the Secretary shall accept
p.001021: applications for grants or contracts under this section from health professions schools, academic health
p.001021: centers, State or local governments, or other appropriate public or private nonprofit entities (or con- sortia of
p.001021: entities, including entities promoting multidisciplinary approaches) for funding and participation in health
p.001021: professions training activities. The Secretary may accept applications from
p.001021: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: for-profit private entities as determined appropriate by the Secretary.
p.001021: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with health professional
p.001021: societies, licensing and accreditation entities, health professions schools, and experts in minority health and
p.001021: cultural competency, prevention, and public health and disability groups, community-based organizations, and
p.001021: other organizations as determined appropriate by the Secretary. The Secretary shall coordinate with
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p.001023: PUBLIC HEALTH SERVICE ACT
p.001023: Sec. 747
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p.001023: who plan to specialize or work in the practice of the fields defined in subparagraph (A);
p.001023: (C) to plan, develop, and operate a program for the training of physicians who plan to teach in family
p.001023: medi- cine, general internal medicine, or general pediatrics train- ing programs;
p.001023: (D) to plan, develop, and operate a program for the training of physicians teaching in community-based
p.001023: set- tings;
p.001023: (E) to provide financial assistance in the form of traineeships and fellowships to physicians who are
p.001023: partici- pants in any such programs and who plan to teach or con- duct research in a family medicine, general internal
p.001023: medi- cine, or general pediatrics training program;
p.001023: (F) to plan, develop, and operate a physician assistant education program, and for the training of individuals who will
p.001023: teach in programs to provide such training;
p.001023: (G) to plan, develop, and operate a demonstration pro- gram that provides training in new competencies, as rec-
p.001023: ommended by the Advisory Committee on Training in Pri- mary Care Medicine and Dentistry and the National
p.001023: Health Care Workforce Commission established in section 5101 of the Patient Protection and Affordable Care
p.001023: Act, which may include—
p.001023: (i) providing training to primary care physicians relevant to providing care through patient-centered
p.001023: medical homes (as defined by the Secretary for pur- poses of this section);
p.001023: (ii) developing tools and curricula relevant to pa- tient-centered medical homes; and
p.001023: (iii) providing continuing education to primary care physicians relevant to patient-centered medical
p.001023: homes; and
p.001023: (H) to plan, develop, and operate joint degree pro- grams to provide interdisciplinary and
p.001023: interprofessional graduate training in public health and other health profes- sions to provide training in
p.001023: environmental health, infec- tious disease control, disease prevention and health pro- motion, epidemiological
p.001023: studies and injury control.
p.001023: (2) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (b) CAPACITY BUILDING IN PRIMARY CARE.—
p.001023: (1) IN GENERAL.—The Secretary may make grants to or enter into contracts with accredited schools of
p.001023: medicine or os- teopathic medicine to establish, maintain, or improve—
p.001023: (A) academic units or programs that improve clinical teaching and research in fields defined in
p.001023: subsection (a)(1)(A); or
p.001023: (B) programs that integrate academic administrative units in fields defined in subsection (a)(1)(A) to
p.001023: enhance interdisciplinary recruitment, training, and faculty devel- opment.
p.001023: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001023: (B) proposes innovative approaches to clinical teaching using models of primary care, such as the patient centered
p.001023: medical home, team management of chronic disease, and interprofessional integrated models of health care
p.001023: that in- corporate transitions in health care settings and integra- tion physical and mental health provision;
p.001023: (C) have a record of training the greatest percentage of providers, or that have demonstrated significant
p.001023: im- provements in the percentage of providers trained, who enter and remain in primary care practice;
p.001023: (D) have a record of training individuals who are from underrepresented minority groups or from a rural or dis-
p.001023: advantaged background;
p.001023: (E) provide training in the care of vulnerable popu- lations such as children, older adults, homeless
p.001023: individ- uals, victims of abuse or trauma, individuals with mental health or substance-related disorders,
p.001023: individuals with HIV/AIDS, and individuals with disabilities;
p.001023: (F) establish formal relationships and submit joint ap- plications with federally qualified health centers, rural
p.001023: health clinics, area health education centers, or clinics lo- cated in underserved areas or that serve
p.001023: underserved pop- ulations;
p.001023: (G) teach trainees the skills to provide interprofes- sional, integrated care through collaboration among health
p.001023: professionals;
p.001023: (H) provide training in enhanced communication with patients, evidence-based practice, chronic disease
p.001023: manage- ment, preventive care, health information technology, or other competencies as recommended by the
p.001023: Advisory Com- mittee on Training in Primary Care Medicine and Den- tistry and the National Health Care
p.001023: Workforce Commis- sion established in section 5101 of the Patient Protection and Affordable Care Act; or
p.001023: (I) provide training in cultural competency and health literacy.
p.001023: (4) DURATION OF AWARDS.—The period during which pay- ments are made to an entity from an award of a grant or
p.001023: con- tract under this subsection shall be 5 years.
p.001023: (c) AUTHORIZATION OF APPROPRIATIONS.—
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p.001025: PUBLIC HEALTH SERVICE ACT
p.001025: Sec. 747A
p.001025:
p.001025: (1) IN GENERAL.—For purposes of carrying out this section (other than subsection (b)(1)(B)), there are authorized to be
p.001025: ap- propriated $125,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years
p.001025: 2011 through 2014.
p.001025: (2) TRAINING PROGRAMS.—Fifteen percent of the amount appropriated pursuant to paragraph (1) in each such
p.001025: fiscal year shall be allocated to the physician assistant training pro- grams described in subsection (a)(1)(F), which
p.001025: prepare students for practice in primary care.
p.001025: (3) INTEGRATING ACADEMIC ADMINISTRATIVE UNITS.—For purposes of carrying out subsection (b)(1)(B), there are
p.001025: author- ized to be appropriated $750,000 for each of fiscal years 2010 through 2014.
p.001025: SEC. 747A. ø293k–1¿ TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.
p.001025: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to enable such entities to provide new
p.001025: training opportuni- ties for direct care workers who are employed in long-term care set- tings such as nursing homes
p.001025: (as defined in section 1908(e)(1) of the Social Security Act (42 U.S.C. 1396g(e)(1)), assisted living facilities and
p.001025: skilled nursing facilities, intermediate care facilities for indi- viduals with mental retardation, home
p.001025: and community based set- tings, and any other setting the Secretary determines to be appro- priate.
p.001025: (b) ELIGIBILITY.—To be eligible to receive a grant under this section, an entity shall—
p.001025: (1) be an institution of higher education (as defined in sec- tion 102 of the Higher Education Act of 1965 (20 U.S.C.
p.001025: 1002)) that—
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p.001025: (A) is accredited by a nationally recognized accrediting agency or association listed under section 101(c) of
p.001025: the Higher Education Act of 1965 (20 U.S.C. 1001(c)); and
p.001025: (B) has established a public-private educational part- nership with a nursing home or skilled nursing
p.001025: facility, agency or entity providing home and community based services to individuals with disabilities, or
p.001025: other long-term care provider; and
p.001025: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001025: Sec- retary may require.
p.001025: (c) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant under this section
p.001025: to provide assistance to eligible individuals to offset the cost of tuition and required fees for enrollment in
p.001025: academic programs provided by such entity.
p.001025: (d) ELIGIBLE INDIVIDUAL.—
p.001025: (1) ELIGIBILITY.—To be eligible for assistance under this section, an individual shall be enrolled in
p.001025: courses provided by a grantee under this subsection and maintain satisfactory aca- demic progress in such courses.
p.001025: (2) CONDITION OF ASSISTANCE.—As a condition of receiving assistance under this section, an individual shall
p.001025: agree that, following completion of the assistance period, the individual will work in the field of geriatrics,
p.001025: disability services, long term
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p.001027: (i) individuals agree to serve full-time as faculty members; and
p.001027: (ii) the program of general, pediatric or public health dentistry agrees to pay the principal and inter- est on
p.001027: the outstanding student loans of the individ- uals.
p.001027: (B) MANNER OF PAYMENTS.—With respect to the pay- ments described in subparagraph (A)(ii), upon completion
p.001027: by an individual of each of the first, second, third, fourth, and fifth years of service, the program
p.001027: shall pay an amount equal to 10, 15, 20, 25, and 30 percent, respec- tively, of the individual’s
p.001027: student loan balance as cal- culated based on principal and interest owed at the initi- ation of the
p.001027: agreement.
p.001027: (b) ELIGIBLE ENTITY.—For purposes of this subsection, entities eligible for such grants or contracts in general,
p.001027: pediatric, or public health dentistry shall include entities that have programs in dental or dental hygiene schools,
p.001027: or approved residency or advanced edu- cation programs in the practice of general, pediatric, or public
p.001027: health dentistry. Eligible entities may partner with schools of pub- lic health to permit the education of dental
p.001027: students, residents, and dental hygiene students for a master’s year in public health at a school of public
p.001027: health.
p.001027: (c) PRIORITIES IN MAKING AWARDS.—With respect to training provided for under this section, the Secretary shall
p.001027: give priority in awarding grants or contracts to the following:
p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
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p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
p.001027: contract under subsection (a) shall be 5 years. The provision of such payments shall be subject to annual
p.001027: approval by the Secretary and subject to the availability of appropriations for the fiscal year involved to
p.001027: make the payments.
p.001027: (f) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out subsections (a) and (b), there is
p.001027: authorized to be ap- propriated $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of
p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
p.001027: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001027: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001027: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 8, the Secretary shall
p.001027: appoint the members of the Advisory Committee from among individuals who are health professionals. In
p.001027: making such appointments, the Secretary shall ensure a fair balance between the health professions, that at
p.001027: least 75 percent of the members of the Ad- visory Committee are health professionals, a broad geographic representation
p.001027: of members and a balance between urban and rural members. Members shall be appointed based on their
p.001027: competence, interest, and knowledge of the mission of the pro- fession involved.
p.001027: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001027: the Sec-
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p.001027: January 30, 2020
p.001027: 8 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted
p.001027: July 1, 1944. Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which
p.001027: added section 748. That Act is Public Law 105–392, enacted November 13, 1998. (Section 102(4) of that Public Law (112
p.001027: Stat. 3539) added section 748.)
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001029: 1029
p.001029: PUBLIC HEALTH SERVICE ACT
p.001029: Sec. 749
p.001029:
p.001029: retary shall ensure the adequate representation of women and minorities.
p.001029: (c) TERMS.—
p.001029: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001029: that of the members first appointed—
p.001029: (A) 1⁄3 of such members shall serve for a term of 1 year;
p.001029: (B) 1⁄3 of such members shall serve for a term of 2 years; and
p.001029: (C) 1⁄3 of such members shall serve for a term of 3 years.
p.001029: (2) VACANCIES.—
p.001029: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
p.001029: original appointment was made and shall be subject to any condi- tions which applied with respect to the
p.001029: original appoint- ment.
p.001029: (B) FILLING UNEXPIRED TERM.—An individual chosen to fill a vacancy shall be appointed for the unexpired term
p.001029: of the member replaced.
p.001029: (d) DUTIES.—The Advisory Committee shall—
p.001029: (1) provide advice and recommendations to the Secretary concerning policy and program development and other
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p.001029: of title 5, United States Code, for each day (including travel time) during which such member is engaged in the
p.001029: performance of the duties of the Committee.
p.001029: (2) EXPENSES.—The members of the Advisory Committee shall be allowed travel expenses, including per diem in lieu
p.001029: of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title
p.001029: 5, United States Code, while away from their homes or regular places of business in the performance of
p.001029: services for the Committee.
p.001029: (g) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section only to the
p.001029: extent that the provisions of such Act do not conflict with the requirements of this section.
p.001029: SEC. 749A. ø293l–1¿ TEACHING HEALTH CENTERS DEVELOPMENT GRANTS.
p.001029: (a) PROGRAM AUTHORIZED.—The Secretary may award grants under this section to teaching health centers for the
p.001029: purpose of es- tablishing new accredited or expanded primary care residency pro- grams.
p.001029: (b) AMOUNT AND DURATION.—Grants awarded under this sec- tion shall be for a term of not more than 3 years and
p.001029: the maximum award may not be more than $500,000.
p.001029: (c) USE OF FUNDS.—Amounts provided under a grant under this section shall be used to cover the costs of—
p.001029: (1) establishing or expanding a primary care residency training program described in subsection (a),
p.001029: including costs associated with—
p.001029: (A) curriculum development;
p.001029: (B) recruitment, training and retention of residents and faculty:
p.001029: (C) accreditation by the Accreditation Council for Graduate Medical Education (ACGME), the American Den-
p.001029: tal Association (ADA), or the American Osteopathic Asso- ciation (AOA); and
p.001029: (D) faculty salaries during the development phase; and
p.001029: (2) technical assistance provided by an eligible entity.
p.001029: (d) APPLICATION.—A teaching health center seeking a grant under this section shall submit an application
p.001029: to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
p.001029: (e) PREFERENCE FOR CERTAIN APPLICATIONS.—In selecting re- cipients for grants under this section, the Secretary
p.001029: shall give pref- erence to any such application that documents an existing affili- ation agreement with an
p.001029: area health education center program as defined in sections 751 and 799B.
p.001029: (f) DEFINITIONS.—In this section:
p.001029: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001031: 1031
p.001031: PUBLIC HEALTH SERVICE ACT
p.001031: Sec. 749B
p.001031:
p.001031: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means an organization capable of providing technical assistance
p.001031: includ- ing an area health education center program as defined in sec- tions 751 and 799B.
p.001031: (2) PRIMARY CARE RESIDENCY PROGRAM.—The term ‘‘pri- mary care residency program’’ means an approved
p.001031: graduate medical residency training program (as defined in section 340H) in family medicine, internal
p.001031: medicine, pediatrics, inter- nal medicine-pediatrics, obstetrics and gynecology, psychiatry, general dentistry,
p.001031: pediatric dentistry, and geriatrics.
p.001031: (3) TEACHING HEALTH CENTER.—
p.001031: (A) IN GENERAL.—The term ‘‘teaching health center’’ means an entity that—
p.001031: (i) is a community based, ambulatory patient care center; and
p.001031: (ii) operates a primary care residency program.
p.001031: (B) INCLUSION OF CERTAIN ENTITIES.—Such term in- cludes the following:
p.001031: (i) A Federally qualified health center (as defined in section 1905(l)(2)(B), of the Social Security Act).
p.001031: (ii) A community mental health center (as defined in section 1861(ff)(3)(B) of the Social Security Act).
p.001031: (iii) A rural health clinic, as defined in section 1861(aa) of the Social Security Act.
p.001031: (iv) A health center operated by the Indian Health Service, an Indian tribe or tribal organization, or an urban
p.001031: Indian organization (as defined in section 4 of the Indian Health Care Improvement Act).
p.001031: (v) An entity receiving funds under title X of the Public Health Service Act.
p.001031: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated, $25,000,000 for fiscal year
p.001031: 2010, $50,000,000 for fiscal year 2011, $50,000,000 for fiscal year 2012, and such sums as may be
p.001031: necessary for each fiscal year thereafter to carry out this section. Not to exceed $5,000,000 annually may be
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p.001033: fiscal years 2010 through 2013.
p.001033:
p.001033: PART D—INTERDISCIPLINARY, COMMUNITY- BASED LINKAGES
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p.001033: SEC. 750. ø294¿ GENERAL PROVISIONS.
p.001033: (a) COLLABORATION.—To be eligible to receive assistance under this part, an academic institution shall use such
p.001033: assistance in col- laboration with 2 or more disciplines.
p.001033: (b) ACTIVITIES.—An entity shall use assistance under this part to carry out innovative demonstration projects for
p.001033: strategic work- force supplementation activities as needed to meet national goals for interdisciplinary,
p.001033: community-based linkages. Such assistance may be used consistent with this part—
p.001033: (1) to develop and support training programs;
p.001033: (2) for faculty development;
p.001033: (3) for model demonstration programs;
p.001033: (4) for the provision of stipends for fellowship trainees;
p.001033: (5) to provide technical assistance; and
p.001033: (6) for other activities that will produce outcomes con- sistent with the purposes of this part.
p.001033: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001033: Sec. 751 PUBLIC HEALTH SERVICE ACT 1034
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p.001033: SEC. 751. ø294a¿ AREA HEALTH EDUCATION CENTERS.
p.001033: (a) ESTABLISHMENT OF AWARDS.—The Secretary shall make the following 2 types of awards in accordance with this section:
p.001033: (1) INFRASTRUCTURE DEVELOPMENT AWARD.—The Secretary shall make awards to eligible entities to enable such
p.001033: entities to initiate health care workforce educational programs or to continue to carry out comparable
p.001033: programs that are operating at the time the award is made by planning, developing, oper- ating, and
p.001033: evaluating an area health education center pro- gram.
p.001033: (2) POINT OF SERVICE MAINTENANCE AND ENHANCEMENT AWARD.—The Secretary shall make awards to eligible
p.001033: entities to maintain and improve the effectiveness and capabilities of an existing area health education
p.001033: center program, and make other modifications to the program that are appropriate due to changes in demographics,
p.001033: needs of the populations served, or other similar issues affecting the area health education center program. For
p.001033: the purposes of this section, the term ‘‘Program’’ refers to the area health education center program.
p.001033: (b) ELIGIBLE ENTITIES; APPLICATION.—
p.001033: (1) ELIGIBLE ENTITIES.—
p.001033: (A) INFRASTRUCTURE DEVELOPMENT.—For purposes of subsection (a)(1), the term ‘‘eligible entity’’ means a school of
p.001033: medicine or osteopathic medicine, an incorporated con- sortium of such schools, or the parent institutions
p.001033: of such a school. With respect to a State in which no area health education center program is in
p.001033: operation, the Secretary may award a grant or contract under subsection (a)(1) to a school of nursing.
p.001033: (B) POINT OF SERVICE MAINTENANCE AND ENHANCE- MENT.—For purposes of subsection (a)(2), the term ‘‘eligible
p.001033: entity’’ means an entity that has received funds under this section, is operating an area health education
p.001033: center pro- gram, including an area health education center or cen- ters, and has a center or centers that are
p.001033: no longer eligible to receive financial assistance under subsection (a)(1).
p.001033: (2) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001033: Secretary an ap- plication at such time, in such manner, and containing such in- formation as the Secretary may
p.001033: require.
p.001033: (c) USE OF FUNDS.—
p.001033: (1) REQUIRED ACTIVITIES.—An eligible entity shall use amounts awarded under a grant under subsection
p.001033: (a)(1) or (a)(2) to carry out the following activities:
p.001033: (A) Develop and implement strategies, in coordination with the 10applicable one-stop delivery system under sec-
p.001033: tion 134(c) of the Workforce Investment Act of 1998, to re- cruit individuals from underrepresented minority popu-
p.001033: lations or from disadvantaged or rural backgrounds into
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p.001033: January 30, 2020
p.001033: 10 Effective on July 1, 2015, section 512(z)(2) of Public Law 113–128 provides for an amend- ment to
p.001033: strike ‘‘the applicable one-stop delivery system under section 134(c) of the Workforce Investment Act of
p.001033: 1998,’’ and insert ‘‘the applicable one-stop delivery system under section 121(e) of the Workforce Innovation
p.001033: and Opportunity Act,’’.
p.001033: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001035: PUBLIC HEALTH SERVICE ACT
p.001035: Sec. 751
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p.001035: health professions, and support such individuals in attain- ing such careers.
p.001035: (B) Develop and implement strategies to foster and provide community-based training and education to indi-
p.001035: viduals seeking careers in health professions within under- served areas for the purpose of developing and
p.001035: maintain- ing a diverse health care workforce that is prepared to de- liver high-quality care, with an emphasis on
p.001035: primary care, in underserved areas or for health disparity populations, in collaboration with other Federal
p.001035: and State health care workforce development programs, the State workforce agency, and local workforce
p.001035: investment boards, and in health care safety net sites.
p.001035: (C) Prepare individuals to more effectively provide health services to underserved areas and health
p.001035: disparity populations through field placements or preceptorships in conjunction with community-based
p.001035: organizations, accred- ited primary care residency training programs, Federally qualified health centers, rural
p.001035: health clinics, public health departments, or other appropriate facilities.
p.001035: (D) Conduct and participate in interdisciplinary train- ing that involves physicians, physician assistants, nurse
p.001035: practitioners, nurse midwives, dentists, psychologists, pharmacists, optometrists, community health
p.001035: workers, public and allied health professionals, or other health pro- fessionals, as practicable.
p.001035: (E) Deliver or facilitate continuing education and in- formation dissemination programs for health care
p.001035: profes- sionals, with an emphasis on individuals providing care in underserved areas and for health disparity
p.001035: populations.
p.001035: (F) Propose and implement effective program and out- comes measurement and evaluation strategies.
p.001035: (G) Establish a youth public health program to expose and recruit high school students into health careers,
p.001035: with a focus on careers in public health.
p.001035: (2) INNOVATIVE OPPORTUNITIES.—An eligible entity may use amounts awarded under a grant under subsection
p.001035: (a)(1) or subsection (a)(2) to carry out any of the following activities:
p.001035: (A) Develop and implement innovative curricula in col- laboration with community-based accredited primary care
p.001035: residency training programs, Federally qualified health centers, rural health clinics, behavioral and mental
p.001035: health facilities, public health departments, or other appropriate facilities, with the goal of increasing
p.001035: the number of pri- mary care physicians and other primary care providers prepared to serve in underserved
p.001035: areas and health dis- parity populations.
p.001035: (B) Coordinate community-based participatory re- search with academic health centers, and facilitate
p.001035: rapid flow and dissemination of evidence-based health care infor- mation, research results, and best practices to
p.001035: improve quality, efficiency, and effectiveness of health care and health care systems within community
p.001035: settings.
p.001035: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001035: (C) Develop and implement other strategies to address identified workforce needs and increase and enhance the
p.001035: health care workforce in the area served by the area health education center program.
p.001035: (d) REQUIREMENTS.—
p.001035: (1) AREA HEALTH EDUCATION CENTER PROGRAM.—In car- rying out this section, the Secretary shall ensure the
p.001035: following:
p.001035: (A) An entity that receives an award under this sec- tion shall conduct at least 10 percent of
p.001035: clinical education required for medical students in community settings that are removed from the primary
p.001035: teaching facility of the con- tracting institution for grantees that operate a school of medicine or
p.001035: osteopathic medicine. In States in which an entity that receives an award under this section is a nurs- ing
p.001035: school or its parent institution, the Secretary shall al- ternatively ensure that—
p.001035: (i) the nursing school conducts at least 10 percent of clinical education required for nursing students in
p.001035: community settings that are remote from the primary teaching facility of the school; and
p.001035: (ii) the entity receiving the award maintains a written agreement with a school of medicine or osteo-
p.001035: pathic medicine to place students from that school in training sites in the area health education center pro-
p.001035: gram area.
p.001035: (B) An entity receiving funds under subsection (a)(2) does not distribute such funding to a center that is
p.001035: eligible to receive funding under subsection (a)(1).
p.001035: (2) AREA HEALTH EDUCATION CENTER.—The Secretary shall ensure that each area health education center program
p.001035: in- cludes at least 1 area health education center, and that each such center—
p.001035: (A) is a public or private organization whose structure, governance, and operation is independent from the award- ee
p.001035: and the parent institution of the awardee;
p.001035: (B) is not a school of medicine or osteopathic medicine, the parent institution of such a school, or a branch campus or
p.001035: other subunit of a school of medicine or osteopathic medicine or its parent institution, or a consortium of
p.001035: such entities;
p.001035: (C) designates an underserved area or population to be served by the center which is in a location removed
p.001035: from the main location of the teaching facilities of the schools participating in the program with such center
p.001035: and does not duplicate, in whole or in part, the geographic area or popu- lation served by any other center;
p.001035: (D) fosters networking and collaboration among com- munities and between academic health centers and com-
p.001035: munity-based centers;
p.001035: (E) serves communities with a demonstrated need of health professionals in partnership with academic medical
p.001035: centers;
p.001035: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001037: (F) addresses the health care workforce needs of the communities served in coordination with the public
p.001037: work- force investment system; and
p.001037: (G) has a community-based governing or advisory board that reflects the diversity of the communities
p.001037: in- volved.
p.001037: (e) MATCHING FUNDS.—With respect to the costs of operating a program through a grant under this section, to
p.001037: be eligible for fi- nancial assistance under this section, an entity shall make avail- able (directly or
p.001037: through contributions from State, county or munic- ipal governments, or the private sector) recurring non-Federal con-
p.001037: tributions in cash or in kind, toward such costs in an amount that is equal to not less than 50 percent of such costs.
p.001037: At least 25 per- cent of the total required non-Federal contributions shall be in cash. An entity may apply to
p.001037: the Secretary for a waiver of not more than 75 percent of the matching fund amount required by the enti- ty for each of
p.001037: the first 3 years the entity is funded through a grant under subsection (a)(1).
p.001037: (f) LIMITATION.—Not less than 75 percent of the total amount provided to an area health education center
p.001037: program under sub- section (a)(1) or (a)(2) shall be allocated to the area health edu- cation centers
p.001037: participating in the program under this section. To provide needed flexibility to newly funded area
p.001037: health education center programs, the Secretary may waive the requirement in the sentence for the first 2
p.001037: years of a new area health education center program funded under subsection (a)(1).
p.001037: (g) AWARD.—An award to an entity under this section shall be not less than $250,000 annually per area health
p.001037: education center included in the program involved. If amounts appropriated to carry out this section are not
p.001037: sufficient to comply with the preceding sen- tence, the Secretary may reduce the per center amount provided for in such
p.001037: sentence as necessary, provided the distribution established in subsection (j)(2) is maintained.
p.001037: (h) PROJECT TERMS.—
p.001037: (1) IN GENERAL.—Except as provided in paragraph (2), the period during which payments may be made under an
p.001037: award under subsection (a)(1) may not exceed—
p.001037: (A) in the case of a program, 12 years; or
p.001037: (B) in the case of a center within a program, 6 years.
p.001037: (2) EXCEPTION.—The periods described in paragraph (1) shall not apply to programs receiving point of
p.001037: service mainte- nance and enhancement awards under subsection (a)(2) to maintain existing centers and
p.001037: activities.
p.001037: (i) INAPPLICABILITY OF PROVISION.—Notwithstanding any other provision of this title, section 791(a) shall not
p.001037: apply to an area health education center funded under this section.
p.001037: (j) AUTHORIZATION OF APPROPRIATIONS.—
p.001037: (1) IN GENERAL.—There is authorized to be appropriated to carry out this section $125,000,000 for each of the fiscal
p.001037: years 2010 through 2014.
p.001037: (2) REQUIREMENTS.—Of the amounts appropriated for a fis- cal year under paragraph (1)—
p.001037: (A) not more than 35 percent shall be used for awards under subsection (a)(1);
p.001037: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001037: (B) not less than 60 percent shall be used for awards under subsection (a)(2);
p.001037: (C) not more than 1 percent shall be used for grants and contracts to implement outcomes evaluation for
p.001037: the area health education centers; and
p.001037: (D) not more than 4 percent shall be used for grants and contracts to provide technical assistance to
p.001037: entities re- ceiving awards under this section.
p.001037: (3) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from 1
p.001037: fiscal year to another without obtaining approval from the Secretary. In no case may any funds be carried
p.001037: over pursuant to the preceding sentence for more than 3 years.
p.001037: (k) SENSE OF CONGRESS.—It is the sense of the Congress that every State have an area health education center
p.001037: program in effect under this section.
p.001037: SEC. 752. ø294b¿ CONTINUING EDUCATIONAL SUPPORT FOR HEALTH PROFESSIONALS SERVING IN UNDERSERVED COMMU-
p.001037: NITIES.
p.001037: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, eligible entities to
p.001037: improve health care, increase retention, increase representation of minority faculty members, enhance
p.001037: the practice environment, and provide informa- tion dissemination and educational support to reduce
p.001037: professional isolation through the timely dissemination of research findings using relevant resources.
p.001037: (b) ELIGIBLE ENTITIES.—For purposes of this section, the term ‘‘eligible entity’’ means an entity described in section
p.001037: 799(b).
p.001037: (c) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001037: Secretary an applica- tion at such time, in such manner, and containing such information as the Secretary may require.
p.001037: (d) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant or contract under this
p.001037: section to provide in- novative supportive activities to enhance education through dis- tance learning,
p.001037: continuing educational activities, collaborative con- ferences, and electronic and telelearning activities, with
p.001037: priority for primary care.
p.001037: (e) AUTHORIZATION.—There is authorized to be appropriated to carry out this section $5,000,000 for each of the
p.001037: fiscal years 2010 through 2014, and such sums as may be necessary for each subse- quent fiscal year.
p.001037: SEC. 753. ø294c¿ EDUCATION AND TRAINING RELATING TO GERI- ATRICS.
p.001037: (a) GERIATRIC EDUCATION CENTERS.—
p.001037: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to entities described in
p.001037: paragraphs 11 (1), (3), or (4) of section 799B, and section 801(2), for the estab- lishment or operation of geriatric
p.001037: education centers.
p.001037: (2) REQUIREMENTS.—A geriatric education center is a pro- gram that—
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p.001037: 11 So in law. Probably should read ‘‘paragraph’’.
p.001037: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001039: PUBLIC HEALTH SERVICE ACT
p.001039: Sec. 753
p.001039:
p.001039: (A) improves the training of health professionals in geriatrics, including geriatric residencies,
p.001039: traineeships, or fellowships;
p.001039: (B) develops and disseminates curricula relating to the treatment of the health problems of elderly individuals;
p.001039: (C) supports the training and retraining of faculty to provide instruction in geriatrics;
p.001039: (D) supports continuing education of health profes- sionals who provide geriatric care; and
p.001039: (E) provides students with clinical training in geri- atrics in nursing homes, chronic and acute disease
p.001039: hos- pitals, ambulatory care centers, and senior centers.
p.001039: (b) GERIATRIC TRAINING REGARDING PHYSICIANS AND DEN-
p.001039: TISTS.—
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p.001039: (1) IN GENERAL.—The Secretary may make grants to, and enter into contracts with, schools of medicine, schools
p.001039: of osteo- pathic medicine, teaching hospitals, and graduate medical edu- cation programs, for the purpose of
p.001039: providing support (includ- ing residencies, traineeships, and fellowships) for geriatric training
p.001039: projects to train physicians, dentists and behavioral and mental health professionals who plan to teach
p.001039: geriatric medicine, geriatric behavioral or mental health, or geriatric dentistry.
p.001039: (2) REQUIREMENTS.—Each project for which a grant or con- tract is made under this subsection shall—
p.001039: (A) be staffed by full-time teaching physicians who have experience or training in geriatric medicine or
p.001039: geri- atric behavioral or mental health;
p.001039: (B) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching dentists
p.001039: who have experience or training in geriatric dentistry;
p.001039: (C) be staffed, or enter into an agreement with an in- stitution staffed by full-time or part-time teaching
p.001039: behav- ioral mental health professionals who have experience or training in geriatric behavioral or mental
p.001039: health;
p.001039: (D) be based in a graduate medical education program in internal medicine or family medicine or in a department of
p.001039: geriatrics or behavioral or mental health;
p.001039: (E) provide training in geriatrics and exposure to the physical and mental disabilities of elderly
p.001039: individuals through a variety of service rotations, such as geriatric consultation services, acute care
p.001039: services, dental services, geriatric behavioral or mental health units, day and home care programs, rehabilitation
p.001039: services, extended care facili- ties, geriatric ambulatory care and comprehensive evalua- tion units, and
p.001039: community care programs for elderly indi- viduals with intellectual disabilities; and
p.001039: (F) provide training in geriatrics through one or both of the training options described in subparagraphs (A)
p.001039: and
p.001039: (B) of paragraph (3).
p.001039: (3) TRAINING OPTIONS.—The training options referred to in subparagraph (F) of paragraph (2) shall be as follows:
p.001039: (A) A 1-year retraining program in geriatrics for—
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001039: January 30, 2020
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p.001039: (i) physicians who are faculty members in depart- ments of internal medicine, family medicine, gyne- cology,
p.001039: geriatrics, and behavioral or mental health at schools of medicine and osteopathic medicine;
p.001039: (ii) dentists who are faculty members at schools of dentistry or at hospital departments of dentistry; and
p.001039: (iii) behavioral or mental health professionals who are faculty members in departments of behavioral or mental
p.001039: health; and
p.001039: (B) A 2-year internal medicine or family medicine fel- lowship program providing emphasis in geriatrics,
p.001039: which shall be designed to provide training in clinical geriatrics and geriatrics research for—
p.001039: (i) physicians who have completed graduate med- ical education programs in internal medicine, family
p.001039: medicine, behavioral or mental health, neurology, gyn- ecology, or rehabilitation medicine;
p.001039: (ii) dentists who have demonstrated a commit- ment to an academic career and who have completed
p.001039: postdoctoral dental training, including postdoctoral dental education programs or who have relevant ad-
p.001039: vanced training or experience; and
p.001039: (iii) behavioral or mental health professionals who have completed graduate medical education programs in
p.001039: behavioral or mental health.
p.001039: (4) DEFINITIONS.—For purposes of this subsection:
p.001039: (A) The term ‘‘graduate medical education program’’ means a program sponsored by a school of medicine, a
p.001039: school of osteopathic medicine, a hospital, or a public or private institution that—
p.001039: (i) offers postgraduate medical training in the spe- cialties and subspecialties of medicine; and
p.001039: (ii) has been accredited by the Accreditation Coun- cil for Graduate Medical Education or the American
p.001039: Osteopathic Association through its Committee on Postdoctoral Training.
p.001039: (B) The term ‘‘post-doctoral dental education program’’ means a program sponsored by a school of dentistry, a hos-
p.001039: pital, or a public or private institution that—
p.001039: (i) offers post-doctoral training in the specialties of dentistry, advanced education in general dentistry, or a
p.001039: dental general practice residency; and
p.001039: (ii) has been accredited by the Commission on Dental Accreditation.
p.001039: (c) GERIATRIC FACULTY FELLOWSHIPS.—
p.001039: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program to provide Geriatric Academic
p.001039: Career Awards to eligible individuals to promote the career develop- ment of such individuals as academic
p.001039: geriatricians.
p.001039: (2) ELIGIBLE INDIVIDUALS.—To be eligible to receive an Award under paragraph (1), an individual shall—
p.001039: (A) be board certified or board eligible in internal med- icine, family practice, psychiatry, or licensed
p.001039: dentistry, or have completed any required training in a discipline and
p.001039: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001041: 1041
p.001041: PUBLIC HEALTH SERVICE ACT
p.001041: Sec. 753
p.001041:
p.001041: employed in an accredited health professions school that is approved by the Secretary;
p.001041: (B) have completed an approved fellowship program in geriatrics or have completed specialty training in geriatrics as
p.001041: required by the discipline and any addition geriatrics training as required by the Secretary; and
p.001041: (C) have a junior (non-tenured) faculty appointment at an accredited (as determined by the Secretary) school of
p.001041: medicine, osteopathic medicine, nursing, social work, psy- chology, dentistry, pharmacy, or other allied
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p.001041: allied health discipline in an accredited health professions school that is approved by the Secretary.
p.001041: (6) SERVICE REQUIREMENT.—An individual who receives an Award under this subsection shall provide training in
p.001041: clinical geriatrics, including the training of interdisciplinary teams of health care professionals. The
p.001041: provision of such training shall
p.001041: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001041: constitute at least 75 percent of the obligations of such indi- vidual under the Award.
p.001041: (d) GERIATRIC WORKFORCE DEVELOPMENT.—
p.001041: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this subsection to entities that operate a
p.001041: geriatric education center pursuant to subsection (a)(1).
p.001041: (2) APPLICATION.—To be eligible for an award under para- graph (1), an entity described in such paragraph shall
p.001041: submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001041: Secretary may require.
p.001041: (3) USE OF FUNDS.—Amounts awarded under a grant or contract under paragraph (1) shall be used to—
p.001041: (A) carry out the fellowship program described in paragraph (4); and
p.001041: (B) carry out 1 of the 2 activities described in para- graph (5).
p.001041: (4) FELLOWSHIP PROGRAM.—
p.001041: (A) IN GENERAL.—Pursuant to paragraph (3), a geri- atric education center that receives an award under
p.001041: this subsection shall use such funds to offer short-term inten- sive courses (referred to in this
p.001041: subsection as a ‘‘fellow- ship’’) that focus on geriatrics, chronic care management, and long-term care that
p.001041: provide supplemental training for faculty members in medical schools and other health pro- fessions schools
p.001041: with programs in psychology, pharmacy, nursing, social work, dentistry, public health, allied health, or other
p.001041: health disciplines, as approved by the Secretary. Such a fellowship shall be open to current faculty, and ap-
p.001041: propriately credentialed volunteer faculty and practi- tioners, who do not have formal training in
p.001041: geriatrics, to upgrade their knowledge and clinical skills for the care of older adults and adults with
p.001041: functional limitations and to enhance their interdisciplinary teaching skills.
p.001041: (B) LOCATION.—A fellowship shall be offered either at
p.001041: the geriatric education center that is sponsoring the course, in collaboration with other geriatric
p.001041: education cen- ters, or at medical schools, schools of dentistry, schools of nursing, schools of pharmacy,
p.001041: schools of social work, grad- uate programs in psychology, or allied health and other health professions
p.001041: schools approved by the Secretary with which the geriatric education centers are affiliated.
p.001041: (C) CME CREDIT.—Participation in a fellowship under this paragraph shall be accepted with respect to complying
p.001041: with continuing health profession education requirements. As a condition of such acceptance, the recipient shall agree
p.001041: to subsequently provide a minimum of 18 hours of vol- untary instructional support through a geriatric
p.001041: education center that is providing clinical training to students or trainees in long-term care settings.
p.001041: (5) ADDITIONAL REQUIRED ACTIVITIES DESCRIBED.—Pursu- ant to paragraph (3), a geriatric education center that
p.001041: receives an award under this subsection shall use such funds to carry out 1 of the following 2 activities.
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p.001043: (A) FAMILY CAREGIVER AND DIRECT CARE PROVIDER TRAINING.—A geriatric education center that receives an
p.001043: award under this subsection shall offer at least 2 courses each year, at no charge or nominal cost, to
p.001043: family care- givers and direct care providers that are designed to pro- vide practical training for
p.001043: supporting frail elders and indi- viduals with disabilities. The Secretary shall require such Centers to work
p.001043: with appropriate community partners to develop training program content and to publicize the
p.001043: availability of training courses in their service areas. All family caregiver and direct care provider
p.001043: training pro- grams shall include instruction on the management of psy- chological and behavioral aspects of dementia,
p.001043: communica- tion techniques for working with individuals who have de- mentia, and the appropriate, safe, and
p.001043: effective use of medications for older adults.
p.001043: (B) INCORPORATION OF BEST PRACTICES.—A geriatric education center that receives an award under this
p.001043: sub- section shall develop and include material on depression and other mental disorders common among
p.001043: older adults, medication safety issues for older adults, and management of the psychological and behavioral
p.001043: aspects of dementia and communication techniques with individuals who have dementia in all training courses,
p.001043: where appropriate.
p.001043: (6) TARGETS.—A geriatric education center that receives an award under this subsection shall meet targets
p.001043: approved by the Secretary for providing geriatric training to a certain num- ber of faculty or practitioners during
p.001043: the term of the award, as well as other parameters established by the Secretary.
p.001043: (7) AMOUNT OF AWARD.—An award under this subsection shall be in an amount of $150,000. Not more than 24
p.001043: geriatric education centers may receive an award under this subsection.
p.001043: (8) MAINTENANCE OF EFFORT.—A geriatric education center that receives an award under this subsection shall provide
p.001043: as- surances to the Secretary that funds provided to the geriatric education center under this subsection
p.001043: will be used only to supplement, not to supplant, the amount of Federal, State, and local funds otherwise expended
p.001043: by the geriatric education cen- ter.
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p.001043: (9) AUTHORIZATION OF APPROPRIATIONS.—In addition to any other funding available to carry out this
p.001043: section, there is authorized to be appropriated to carry out this subsection,
p.001043: $10,800,000 for the period of fiscal year 2011 through 2014.
p.001043: (e) GERIATRIC CAREER INCENTIVE AWARDS.—
p.001043: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to individuals described in
p.001043: paragraph
p.001043: (2) to foster greater interest among a variety of health profes- sionals in entering the field of
p.001043: geriatrics, long-term care, and chronic care management.
p.001043: (2) ELIGIBLE INDIVIDUALS.—To be eligible to received an award under paragraph (1), an individual shall—
p.001043: (A) be an advanced practice nurse, a clinical social worker, a pharmacist, or student of psychology who is pur-
p.001043: suing a doctorate or other advanced degree in geriatrics or
p.001043: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001045: served or rural communities in order to increase the num- ber of individuals trained;
p.001045: (F) those that develop curriculum that will emphasize knowledge and practice in the areas of prevention and
p.001045: health promotion, geriatrics, long-term care, home health and hospice care, and ethics;
p.001045: (G) those that expand or establish interdisciplinary training programs that promote the effectiveness of
p.001045: allied health practitioners in geriatric assessment and the reha- bilitation of the elderly;
p.001045: (H) those that expand or establish demonstration cen- ters to emphasize innovative models to link allied health
p.001045: clinical practice, education, and research;
p.001045: (I) those that provide financial assistance (in the form of traineeships) to students who are participants in
p.001045: any such program; and
p.001045: (i) who plan to pursue a career in an allied health field that has a demonstrated personnel shortage; and
p.001045: (ii) who agree upon completion of the training pro- gram to practice in a medically underserved commu- nity;
p.001045: that shall be utilized to assist in the payment of all or part of the costs associated with tuition, fees and such
p.001045: other sti- pends as the Secretary may consider necessary; and
p.001045: (J) those to meet the costs of projects to plan, develop, and operate or maintain graduate programs in
p.001045: behavioral and mental health practice.
p.001045: (2) Planning and implementing projects in preventive and primary care training for podiatric physicians in
p.001045: approved or provisionally approved residency programs that shall provide financial assistance in the form
p.001045: of traineeships to residents who participate in such projects and who plan to specialize in primary care.
p.001045: (3) Carrying out demonstration projects in which chiro- practors and physicians collaborate to identify
p.001045: and provide ef- fective treatment for spinal and lower-back conditions.
p.001045: SEC. 756. ø294e–1¿ MENTAL AND BEHAVIORAL HEALTH EDUCATION AND TRAINING GRANTS.
p.001045: (a) GRANTS AUTHORIZED.—The Secretary may award grants to eligible institutions to support the recruitment of students
p.001045: for, and education and clinical experience of the students in—
p.001045: (1) accredited institutions of higher education or accredited professional training programs that are establishing or
p.001045: expand- ing internships or other field placement programs in mental health in psychiatry, psychology, school
p.001045: psychology, behavioral pediatrics, psychiatric nursing (which may include master’s and doctoral level
p.001045: programs), social work, school social work, substance use disorder prevention and treatment, marriage and
p.001045: family therapy, occupational therapy, school counseling, or professional counseling, including such programs with
p.001045: a focus on child and adolescent mental health, trauma, and transi- tional-age youth;
p.001045: (2) accredited doctoral, internship, and post-doctoral resi- dency programs of health service psychology
p.001045: (including clinical
p.001045: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001047: PUBLIC HEALTH SERVICE ACT
p.001047: Sec. 756
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p.001047: (b) COMPOSITION.—
p.001047: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001047: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001047: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 12, the Secretary
p.001047: shall appoint the members of the Advisory Committee from among individuals who are health professionals
p.001047: from schools of the types de- scribed in sections 751(b)(1)(A), 753(b), and 755(b). In making such
p.001047: appointments, the Secretary shall ensure a fair balance between the health professions, that at least 75 percent
p.001047: of the members of the Advisory Committee are health professionals, a broad geographic representation of
p.001047: members and a balance between urban and rural members. Members shall be ap- pointed based on their
p.001047: competence, interest, and knowledge of the mission of the profession involved.
p.001047: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001047: the Sec- retary shall ensure the adequate representation of women and minorities.
p.001047: (c) TERMS.—
p.001047:
p.001047:
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p.001047:
p.001047: January 30, 2020
p.001047: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001047: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 756.
p.001047: That Act is Public Law 105–392, enacted November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541) added
p.001047: section 756.)
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001049: 1049
p.001049: PUBLIC HEALTH SERVICE ACT
p.001049: Sec. 757
p.001049:
p.001049: (1) IN GENERAL.—A member of the Advisory Committee shall be appointed for a term of 3 years, except
p.001049: that of the members first appointed—
p.001049: (A) 1⁄3 of the members shall serve for a term of 1 year;
p.001049: (B) 1⁄3 of the members shall serve for a term of 2 years; and
p.001049: (C) 1⁄3 of the members shall serve for a term of 3 years.
p.001049: (2) VACANCIES.—
p.001049: (A) IN GENERAL.—A vacancy on the Advisory Com- mittee shall be filled in the manner in which the
p.001049: original appointment was made and shall be subject to any condi- tions which applied with respect to the
p.001049: original appoint- ment.
p.001049: (B) FILLING UNEXPIRED TERM.—An individual chosen to fill a vacancy shall be appointed for the unexpired term
p.001049: of the member replaced.
p.001049: (d) DUTIES.—The Advisory Committee shall—
p.001049: (1) provide advice and recommendations to the Secretary concerning policy and program development and other
p.001049: matters of significance concerning the activities under this part;
p.001049: (2) not later than 3 years after the date of enactment of this section, and annually thereafter,
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p.001049:
p.001049: (1) COMPENSATION.—Each member of the Advisory Com- mittee shall be compensated at a rate equal to the daily
p.001049: equiv- alent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315
p.001049: of title 5, United States Code, for each day (including travel time) during which such member is engaged in the
p.001049: performance of the duties of the Committee.
p.001049: (2) EXPENSES.—The members of the Advisory Committee shall be allowed travel expenses, including per diem in lieu
p.001049: of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title
p.001049: 5, United States Code, while away from their homes or regular places of business in the performance of
p.001049: services for the Committee.
p.001049: (g) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section only to the
p.001049: extent that the provisions of such Act do not conflict with the requirements of this section.
p.001049: øNote: Section 758 was repealed by section 501(b)(2) of Public Law 113–4; enacted March 7, 2013, 127 Stat. 54.¿
p.001049: SEC. 759. ø294i¿ PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE.
p.001049: (a) IN GENERAL.—The Secretary may make awards of grants, cooperative agreements, and contracts to
p.001049: health professions schools, hospices, tribal health programs (as defined in section 4 of the Indian Health Care
p.001049: Improvement Act), and other public and nonprofit private entities for the development and implementation of
p.001049: programs to provide education and training to health care pro- fessionals in pain care.
p.001049: (b) CERTAIN TOPICS.—An entity receiving an award under this section shall develop a comprehensive education and
p.001049: training plan that includes information and education on—
p.001049: (1) recognized means for assessing, diagnosing, preventing, treating, and managing pain and related signs and symptoms,
p.001049: including non-addictive medical products and non-pharmaco- logic treatments and the medically appropriate
p.001049: use of con- trolled substances;
p.001049: (2) applicable Federal, State, and local laws, regulations, rules, and policies on controlled substances,
p.001049: including opioids;
p.001049: (3) interdisciplinary approaches to the delivery of pain care, including delivery through specialized
p.001049: centers providing comprehensive pain care treatment expertise, integrated, evi- dence-based pain management,
p.001049: and, as appropriate, non- pharmacotherapy;
p.001049: (4) cultural, linguistic, literacy, geographic, and other bar- riers to care in underserved populations;
p.001049: (5) recent findings, developments, and advancements in pain care research and the provision of pain care,
p.001049: which may include non-addictive medical products and non-pharmacologic treatments intended to treat pain; and
p.001049: (6) the dangers of opioid abuse and misuse, detection of early warning signs of opioid use disorders (which
p.001049: may include best practices related to screening for opioid use disorders, training on screening, brief
p.001049: intervention, and referral to treat-
p.001049: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001051: (III) an in-person training track that includes a rotation during which the resident practices in a
p.001051: community-based setting that specializes in the treatment of infants, children, adolescents, or pregnant
p.001051: or postpartum women; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such training.
p.001051: (2) TRAINING FOR OTHER PROVIDERS.—A recipient of a grant under subsection (a)(2)—
p.001051: (A) shall use the grant funds to plan, develop, or oper- ate a training program to provide mental and substance
p.001051: use disorders services in underserved, community-based settings, as appropriate, that integrate primary care
p.001051: and mental and substance use disorders prevention and treat- ment services; and
p.001051: (B) may use the grant funds to provide additional sup- port for the administration of the program or to meet
p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
p.001051: College Accreditation, the Accreditation Commission for Education in Nursing, the Commission on Col- legiate Nursing
p.001051: Education, the Accreditation Council for Phar- macy Education, the Council on Social Work Education, Amer- ican
p.001051: Psychological Association Commission on Accreditation, or the Accreditation Review Commission on Education for
p.001051: the Physician Assistant) to carry out activities under subsection (a)(3).
p.001051: (c) ELIGIBLE ENTITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—To be eligible to receive a grant under subsection (a)(1), an entity shall—
p.001051: (A) be a consortium consisting of—
p.001051: (i) at least one teaching health center; and
p.001051: (ii) the sponsoring institution (or parent institu- tion of the sponsoring institution) of—
p.001051: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001053: 1053
p.001053: PUBLIC HEALTH SERVICE ACT
p.001053: Sec. 760
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p.001053: (I) a psychiatry residency program that is ac- credited by the Accreditation Council of Graduate Medical
p.001053: Education (or the parent institution of such a program); or
p.001053: (II) a fellowship in addiction medicine, as de- termined appropriate by the Secretary; or
p.001053: (B) be an entity described in subparagraph (A)(ii) that provides opportunities for residents or fellows to train
p.001053: in community-based settings that integrate primary care with mental and substance use disorders prevention and
p.001053: treat- ment services.
p.001053: (2) TRAINING FOR OTHER PROVIDERS.—To be eligible to re- ceive a grant under subsection (a)(2), an entity shall
p.001053: be—
p.001053: (A) a teaching health center (as defined in section 749A(f));
p.001053: (B) a Federally qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act);
p.001053: (C) a community mental health center (as defined in section 1861(ff)(3)(B) of the Social Security Act);
p.001053: (D) a rural health clinic (as defined in section 1861(aa) of the Social Security Act);
p.001053: (E) a health center operated by the Indian Health Service, an Indian tribe, a tribal organization, or an urban
p.001053: Indian organization (as defined in section 4 of the Indian Health Care Improvement Act); or
p.001053: (F) an entity with a demonstrated record of success in providing training for nurse practitioners, physician assist-
p.001053: ants, health service psychologists, and social workers.
p.001053: (3) ACADEMIC UNITS OR PROGRAMS.—To be eligible to re- ceive a grant under subsection (a)(3), an
p.001053: entity shall be a school of medicine or osteopathic medicine, a nursing school, a physician assistant training
p.001053: program, a school of pharmacy, a school of social work, an accredited public or nonprofit private hospital, an
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p.001055: Sec. 761 PUBLIC HEALTH SERVICE ACT 1056
p.001055:
p.001055: subparagraph (A), the National Center may enter into con- tracts with relevant professional and educational organiza-
p.001055: tions or societies.
p.001055: (c) STATE AND REGIONAL CENTERS FOR HEALTH WORKFORCE ANALYSIS.—
p.001055: (1) IN GENERAL.—The Secretary shall award grants to, or enter into contracts with, eligible entities for
p.001055: purposes of—
p.001055: (A) collecting, analyzing, and reporting data regarding programs under this title to the National Center and
p.001055: to the public; and
p.001055: (B) providing technical assistance to local and regional entities on the collection, analysis, and reporting of
p.001055: data.
p.001055: (2) ELIGIBLE ENTITIES.—To be eligible for a grant or con- tract under this subsection, an entity shall—
p.001055: (A) be a State, a State workforce investment board, a public health or health professions school, an
p.001055: academic health center, or an appropriate public or private nonprofit entity; and
p.001055: (B) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001055: Secretary may require.
p.001055: (d) INCREASE IN GRANTS FOR LONGITUDINAL EVALUATIONS.—
p.001055: (1) IN GENERAL.—The Secretary shall increase the amount awarded to an eligible entity under this title for a
p.001055: longitudinal evaluation of individuals who have received education, train- ing, or financial assistance from
p.001055: programs under this title.
p.001055: (2) CAPABILITY.—A longitudinal evaluation shall be capa- ble of—
p.001055: (A) studying practice patterns; and
p.001055: (B) collecting and reporting data on performance measures developed under sections 749(d)(3),
p.001055: 757(d)(3), and 762(a)(3).
p.001055: (3) GUIDELINES.—A longitudinal evaluation shall comply with guidelines issued under sections 749(d)(4),
p.001055: 757(d)(4), and 762(a)(4).
p.001055: (4) ELIGIBLE ENTITIES.—To be eligible to obtain an increase under this section, an entity shall be a recipient
p.001055: of a grant or contract under this title.
p.001055: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.001055: (1) IN GENERAL.—
p.001055: (A) NATIONAL CENTER.—To carry out subsection (b), there are authorized to be appropriated $7,500,000 for
p.001055: each of fiscal years 2010 through 2014.
p.001055: (B) STATE AND REGIONAL CENTERS.—To carry out sub- section (c), there are authorized to be appropriated
p.001055: $4,500,000 for each of fiscal years 2010 through 2014.
p.001055: (C) GRANTS FOR LONGITUDINAL EVALUATIONS.—To carry out subsection (d), there are authorized to be appro-
p.001055: priated such sums as may be necessary for fiscal years 2010 through 2014.
p.001055:
p.001055: January 30, 2020 As Amended Through P.L. 116-94,
p.001055: Enacted December 20, 2019
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p.001057: 1057
p.001057: PUBLIC HEALTH SERVICE ACT
p.001057: Sec. 762
p.001057:
p.001057: (2) RESERVATION.—Of the amounts appropriated under subsection (a) 14 for a fiscal year, the Secretary
p.001057: shall reserve not less than $600,000 for conducting health professions re- search and for carrying out data
p.001057: collection and analysis in ac- cordance with section 792.
p.001057: (3) AVAILABILITY OF ADDITIONAL FUNDS.—Amounts other- wise appropriated for programs or activities under
p.001057: this title may be used for activities under subsection (b) with respect to the programs or activities from which
p.001057: such amounts were made available.
p.001057: SEC. 762. ø294o¿ ADVISORY COUNCIL ON GRADUATE MEDICAL EDU- CATION.
p.001057: (a) ESTABLISHMENT; DUTIES.—There is established the Council on Graduate Medical Education (in this section
p.001057: referred to as the ‘‘Council’’). The Council shall—
p.001057: (1) make recommendations to the Secretary of Health and Human Services (in this section referred to as the
p.001057: ‘‘Secretary’’), and to the Committee on Labor and Human Resources of the Senate, and the Committee on
p.001057: Energy and Commerce of the House of Representatives, with respect to—
p.001057: (A) the supply and distribution of physicians in the United States;
p.001057: (B) current and future shortages or excesses of physi- cians in medical and surgical specialties and
p.001057: subspecial- ties;
p.001057: (C) issues relating to foreign medical school graduates;
p.001057: (D) appropriate Federal policies with respect to the matters specified in subparagraphs (A), (B), and
p.001057: (C), in- cluding policies concerning changes in the financing of un- dergraduate and graduate medical
p.001057: education programs and changes in the types of medical education training in graduate medical education
p.001057: programs;
p.001057: (E) appropriate efforts to be carried out by hospitals, schools of medicine, schools of osteopathic
p.001057: medicine, and accrediting bodies with respect to the matters specified in subparagraphs (A), (B), and
p.001057: (C), including efforts for changes in undergraduate and graduate medical education programs; and
p.001057: (F) deficiencies in, and needs for improvements in, ex- isting data bases concerning the supply and distribution
p.001057: of, and postgraduate training programs for, physicians in the United States and steps that should be taken to
p.001057: elimi- nate those deficiencies;
p.001057: (2) encourage entities providing graduate medical edu- cation to conduct activities to
p.001057: voluntarily achieve the rec- ommendations of the Council under paragraph (1)(E);
p.001057: (3) develop, publish, and implement performance measures for programs under this title, except for programs
p.001057: under part C or D;
p.001057:
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p.001057: January 30, 2020
p.001057: 14 The reference to ‘‘subsection (a)’’ in subsection (e)(2) probably should read ‘‘paragraph (1)’’.
p.001057: Paragraph (4) of section 5103(a) of PL 111–148 probably should have been designated as a sub- paragraph (B) of
p.001057: paragraph (3) of such section. As such, the amendment instruction in para- graph (4) to strike ‘‘subsection
p.001057: (a)’’ and insert ‘‘paragraph (1)’’ could not be executed since it did not specify to which subsection to carry out the
p.001057: amendment.
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p.001059: (k) TERMINATION.—The Council shall terminate September 30, 2003 15.
p.001059: (l) FUNDING.—Amounts otherwise appropriated under this title may be utilized by the Secretary to support the
p.001059: activities of the Council.
p.001059: SEC. 763. ø294p¿ PEDIATRIC RHEUMATOLOGY.
p.001059: (a) IN GENERAL.—The Secretary, acting through the appro- priate agencies, shall evaluate whether the
p.001059: number of pediatric rheumatologists is sufficient to address the health care needs of children with
p.001059: arthritis and related conditions, and if the Secretary determines that the number is not sufficient, shall
p.001059: develop strate- gies to help address the shortfall.
p.001059: (b) REPORT TO CONGRESS.—Not later than October 1, 2001, the Secretary shall submit to the Congress a report
p.001059: describing the re- sults of the evaluation under subsection (a), and as applicable, the strategies developed under
p.001059: such subsection.
p.001059: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001059: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001059:
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p.001059: January 30, 2020
p.001059: 15 Appropriations Acts for the Department of Health and Human Services for fiscal years 2004 and 2005 provided for
p.001059: the continued operation of the Council. See section 219 of division E of Public Law 108–199 (118 Stat.
p.001059: 255) and section 218 of division F of Public Law 108–447 (118 Stat. 3141). Each of such sections refers to
p.001059: ‘‘the Council on Graduate Education established by section 301 of Public Law 102–408’’. Such section 301 was
p.001059: transferred to the Public Health Serv- ice Act as section 762 above by section 104(b) of Public Law 105–392 (112 Stat.
p.001059: 3552).
p.001059: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001059: Sec. 765 PUBLIC HEALTH SERVICE ACT
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p.001059: Subpart 2—Public Health Workforce
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p.001060: January 30, 2020
p.001060: SEC. 765. ø295¿ GENERAL PROVISIONS.
p.001060: (a) IN GENERAL.—The Secretary may award grants or contracts to eligible entities to increase the number of individuals
p.001060: in the pub- lic health workforce, to enhance the quality of such workforce, and to enhance the ability of the workforce
p.001060: to meet national, State, and local health care needs.
p.001060: (b) ELIGIBILITY.—To be eligible to receive a grant or contract under subsection (a) an entity shall—
p.001060: (1) be—
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p.001060: address pri- ority public health, preventive medicine, public health den- tistry, and health administration
p.001060: needs;
p.001060: (7) preparing public health professionals for employment at the State and community levels;
p.001060: (8) public health workforce loan repayment programs; or
p.001060: (9) other activities that may produce outcomes that are consistent with the purposes of this section.
p.001060: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001061: PUBLIC HEALTH SERVICE ACT
p.001061: Sec. 766
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p.001061: (e) TRAINEESHIPS.—
p.001061: (1) IN GENERAL.—With respect to amounts used under this section for the training of health professionals, such
p.001061: training programs shall be designed to—
p.001061: (A) make public health education more accessible to the public and private health workforce;
p.001061: (B) increase the relevance of public health academic preparation to public health practice in the future;
p.001061: (C) provide education or training for students from traditional on-campus programs in practice-based sites;
p.001061: or
p.001061: (D) develop educational methods and distance-based approaches or technology that address adult learning re-
p.001061: quirements and increase knowledge and skills related to community-based cultural diversity in public health
p.001061: edu- cation.
p.001061: (2) SEVERE SHORTAGE DISCIPLINES.—Amounts provided under grants or contracts under this section may be
p.001061: used for the operation of programs designed to award traineeships to students in accredited schools of
p.001061: public health who enter edu- cational programs in fields where there is a severe shortage of public health
p.001061: professionals, including epidemiology, biostatis- tics, environmental health, toxicology, public health
p.001061: nursing, nutrition, preventive medicine, maternal and child health, and behavioral and mental health professions.
p.001061: SEC. 766. ø295a¿ PUBLIC HEALTH TRAINING CENTERS.
p.001061: (a) IN GENERAL.—The Secretary may make grants or contracts for the operation of public health training centers.
p.001061: (b) ELIGIBLE ENTITIES.—
p.001061: (1) IN GENERAL.—A public health training center shall be an accredited school of public health, or another
p.001061: public or non- profit private institution accredited for the provision of grad- uate or specialized training in
p.001061: public health, that plans, devel- ops, operates, and evaluates projects that are in furtherance of the goals
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p.001063: (B) programs that improve clinical teaching in preven- tive medicine and public health.
p.001063: (d) REPORT.—The Secretary shall submit to the Congress an annual report on the program carried out under this
p.001063: section.
p.001063: SEC. 769. ø295d¿ HEALTH ADMINISTRATION TRAINEESHIPS AND SPE- CIAL PROJECTS.
p.001063: (a) IN GENERAL.—The Secretary may make grants to State or local governments (that have in effect preventive
p.001063: medical and den- tal public health residency programs) or public or nonprofit private educational entities (including
p.001063: graduate schools of social work and business schools that have health management programs) that offer a program
p.001063: described in subsection (b)—
p.001063: (1) to provide traineeships for students enrolled in such a program; and
p.001063: (2) to assist accredited programs health administration in the development or improvement of programs to
p.001063: prepare stu- dents for employment with public or nonprofit private entities.
p.001063: (b) RELEVANT PROGRAMS.—The program referred to in sub- section (a) is an accredited program in health
p.001063: administration, hos- pital administration, or health policy analysis and planning, which program is accredited by a
p.001063: body or bodies approved for such pur- pose by the Secretary of Education and which meets such other
p.001063: quality standards as the Secretary of Health and Human Services by regulation may prescribe.
p.001063: (c) PREFERENCE IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give preference to
p.001063: qualified ap- plicants that meet the following conditions:
p.001063: (1) Not less than 25 percent of the graduates of the appli- cant are engaged in full-time practice settings in
p.001063: medically un- derserved communities.
p.001063: (2) The applicant recruits and admits students from medi- cally underserved communities.
p.001063: (3) For the purpose of training students, the applicant has established relationships with public and nonprofit
p.001063: providers of health care in the community involved.
p.001063: (4) In training students, the applicant emphasizes employ- ment with public or nonprofit private entities.
p.001063: (d) CERTAIN PROVISIONS REGARDING TRAINEESHIPS.—
p.001063: (1) USE OF GRANT.—Traineeships awarded under grants made under subsection (a) shall provide for tuition
p.001063: and fees and such stipends and allowances (including travel and sub- sistence expenses and dependency
p.001063: allowances) for the trainees as the Secretary may deem necessary.
p.001063: (2) PREFERENCE FOR CERTAIN STUDENTS.—Each entity ap- plying for a grant under subsection (a) for
p.001063: traineeships shall assure to the satisfaction of the Secretary that the entity will give priority to
p.001063: awarding the traineeships to students who demonstrate a commitment to employment with public or non- profit
p.001063: private entities in the fields with respect to which the traineeships are awarded.
p.001063: SEC. 770. ø295e¿ AUTHORIZATION OF APPROPRIATIONS.
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p.001063: (b) LIMITATION REGARDING CERTAIN PROGRAM.—In obligating amounts appropriated under subsection (a), the
p.001063: Secretary may not obligate more than 30 percent for carrying out section 767.
p.001063: Subpart 3—Recruitment and Retention Programs
p.001063:
p.001063: SEC. 775. ø295f¿ INVESTMENT IN TOMORROW’S PEDIATRIC HEALTH CARE WORKFORCE.
p.001063: (a) ESTABLISHMENT.—The Secretary shall establish and carry out a pediatric specialty loan repayment program under
p.001063: which the eligible individual agrees to be employed full-time for a specified period (which shall not be less
p.001063: than 2 years) in providing pediatric medical subspecialty, pediatric surgical specialty, or child and ado- lescent
p.001063: mental and behavioral health care, including substance abuse prevention and treatment services.
p.001063: (b) PROGRAM ADMINISTRATION.—Through the program estab- lished under this section, the Secretary shall enter
p.001063: into contracts with qualified health professionals under which—
p.001063: (1) such qualified health professionals will agree to provide pediatric medical subspecialty, pediatric surgical
p.001063: specialty, or child and adolescent mental and behavioral health care in an area with a shortage of the
p.001063: specified pediatric subspecialty that has a sufficient pediatric population to support such pediatric
p.001063: subspecialty, as determined by the Secretary; and
p.001063: (2) the Secretary agrees to make payments on the prin- cipal and interest of undergraduate, graduate, or
p.001063: graduate medical education loans of professionals described in para- graph (1) of not more than $35,000
p.001063: a year for each year of agreed upon service under such paragraph for a period of not more than 3
p.001063: years during the qualified health professional’s—
p.001063: (A) participation in an accredited pediatric medical subspecialty, pediatric surgical specialty, or child and
p.001063: ado- lescent mental health subspecialty residency or fellowship; or
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p.001063: (B) employment as a pediatric medical subspecialist, pediatric surgical specialist, or child and adolescent
p.001063: mental health professional serving an area or population described in such paragraph.
p.001063: (c) IN GENERAL.—
p.001063: (1) ELIGIBLE INDIVIDUALS.—
p.001063: (A) PEDIATRIC MEDICAL SPECIALISTS AND PEDIATRIC SURGICAL SPECIALISTS.—For purposes of contracts with re-
p.001063: spect to pediatric medical specialists and pediatric surgical specialists, the term ‘‘qualified health
p.001063: professional’’ means a licensed physician who—
p.001063: (i) is entering or receiving training in an accred- ited pediatric medical subspecialty or pediatric sur-
p.001063: gical specialty residency or fellowship; or
p.001063: (ii) has completed (but not prior to the end of the calendar year in which this section is enacted) the
p.001063: training described in subparagraph (B).
p.001063: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001065: professional counseling;
p.001065: (ii) has a license or certification in a State to prac- tice allopathic medicine, osteopathic medicine, psy-
p.001065: chology, school psychology, psychiatric nursing, social work, school social work, marriage and family therapy,
p.001065: school counseling, or professional counseling; or
p.001065: (iii) is a mental health service professional who completed (but not before the end of the calendar year in
p.001065: which this section is enacted) specialized training or clinical experience in child and adolescent mental
p.001065: health described in clause (i).
p.001065: (2) ADDITIONAL ELIGIBILITY REQUIREMENTS.—The Secretary may not enter into a contract under this subsection with an
p.001065: eli- gible individual unless—
p.001065: (A) the individual agrees to work in, or for a provider serving, a health professional shortage area or
p.001065: medically underserved area, or to serve a medically underserved pop- ulation;
p.001065: (B) the individual is a United States citizen or a per- manent legal United States resident; and
p.001065: (C) if the individual is enrolled in a graduate program, the program is accredited, and the individual has an
p.001065: ac- ceptable level of academic standing (as determined by the Secretary).
p.001065: (d) PRIORITY.—In entering into contracts under this subsection, the Secretary shall give priority to applicants who—
p.001065: (1) are or will be working in a school or other pre-kinder- garten, elementary, or secondary education
p.001065: setting;
p.001065: (2) have familiarity with evidence-based methods and cul- tural and linguistic competence health care services;
p.001065: and
p.001065: (3) demonstrate financial need.
p.001065: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $30,000,000 for each of
p.001065: fiscal years 2010 through 2014 to carry out subsection (c)(1)(A) and $20,000,000 for each of fiscal
p.001065: years 2010 through 2013 to carry out subsection (c)(1)(B).
p.001065: SEC. 776. ø295f–1¿ PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
p.001065: (a) ESTABLISHMENT.—The Secretary shall establish the Public Health Workforce Loan Repayment Program
p.001065: (referred to in this section as the ‘‘Program’’) to assure an adequate supply of public health
p.001065: professionals to eliminate critical public health workforce shortages in Federal, State, local, and tribal public
p.001065: health agencies.
p.001065: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001065: (b) ELIGIBILITY.—To be eligible to participate in the Program, an individual shall—
p.001065: (1)(A) be accepted for enrollment, or be enrolled, as a stu- dent in an accredited academic educational
p.001065: institution in a State or territory in the final year of a course of study or pro- gram leading to a public health or
p.001065: health professions degree or certificate; and have accepted employment with a Federal, State, local, or tribal
p.001065: public health agency, or a related training fellowship, as recognized by the Secretary, to commence upon
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p.001065: (B)(i) have graduated, during the preceding 10-year period, from an accredited educational institution in a
p.001065: State or terri- tory and received a public health or health professions degree or certificate; and
p.001065: (ii) be employed by, or have accepted employment with, a Federal, State, local, or tribal public health agency
p.001065: or a related training fellowship, as recognized by the Secretary;
p.001065: (2) be a United States citizen; and
p.001065: (3)(A) submit an application to the Secretary to participate in the Program;
p.001065: (B) execute a written contract as required in subsection (c);
p.001065: and
p.001065: (4) not have received, for the same service, a reduction of
p.001065: loan obligations under section 455(m), 428J, 428K, 428L, or 460 of the Higher Education Act of 1965.
p.001065: (c) CONTRACT.—The written contract (referred to in this section as the ‘‘written contract’’) between the Secretary and
p.001065: an individual shall contain—
p.001065: (1) an agreement on the part of the Secretary that the Sec- retary will repay on behalf of the individual loans
p.001065: incurred by the individual in the pursuit of the relevant degree or certifi- cate in accordance with the
p.001065: terms of the contract;
p.001065: (2) an agreement on the part of the individual that the in- dividual will serve in the full-time employment of
p.001065: a Federal, State, local, or tribal public health agency or a related fellow- ship program in a position
p.001065: related to the course of study or program for which the contract was awarded for a period of time
p.001065: (referred to in this section as the ‘‘period of obligated serv- ice’’) equal to the greater of—
p.001065: (A) 3 years; or
p.001065: (B) such longer period of time as determined appro- priate by the Secretary and the individual;
p.001065: (3) an agreement, as appropriate, on the part of the indi- vidual to relocate to a priority service
p.001065: area (as determined by the Secretary) in exchange for an additional loan repayment incentive amount to be
p.001065: determined by the Secretary;
p.001065: (4) a provision that any financial obligation of the United States arising out of a contract entered into
p.001065: under this section and any obligation of the individual that is conditioned there- on, is contingent on
p.001065: funds being appropriated for loan repay- ments under this section;
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p.001065: 16 So in law. There should probably be an ‘‘or’’ at the end of subparagraph (A).
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p.001067: PUBLIC HEALTH SERVICE ACT
p.001067: Sec. 777
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p.001067: (5) a statement of the damages to which the United States is entitled, under this section for the individual’s breach
p.001067: of the contract; and
p.001067: (6) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with
p.001067: this sec- tion.
p.001067: (d) PAYMENTS.—
p.001067: (1) IN GENERAL.—A loan repayment provided for an indi- vidual under a written contract under the Program
p.001067: shall con- sist of payment, in accordance with paragraph (2), on behalf of the individual of the principal,
p.001067: interest, and related expenses on government and commercial loans received by the indi- vidual regarding
p.001067: the undergraduate or graduate education of the individual (or both), which loans were made for tuition ex- penses
p.001067: incurred by the individual.
p.001067: (2) PAYMENTS FOR YEARS SERVED.—For each year of obli- gated service that an individual contracts to
p.001067: serve under sub- section (c) the Secretary may pay up to $35,000 on behalf of the individual for loans
p.001067: described in paragraph (1). With re- spect to participants under the Program whose total eligible loans
p.001067: are less than $105,000, the Secretary shall pay an amount that does not exceed 1⁄3 of the eligible loan
p.001067: balance for each year of obligated service of the individual.
p.001067: (3) TAX LIABILITY.—For the purpose of providing reim- bursements for tax liability resulting from payments
p.001067: under paragraph (2) on behalf of an individual, the Secretary shall, in addition to such payments, make
p.001067: payments to the individual in an amount not to exceed 39 percent of the total amount of loan repayments
p.001067: made for the taxable year involved.
p.001067: (e) POSTPONING OBLIGATED SERVICE.—With respect to an indi- vidual receiving a degree or certificate from a health
p.001067: professions or other related school, the date of the initiation of the period of obli- gated service may be postponed
p.001067: as approved by the Secretary.
p.001067: (f) BREACH OF CONTRACT.—An individual who fails to comply with the contract entered into under subsection (c)
p.001067: shall be subject to the same financial penalties as provided for under section 338E for breaches of loan repayment
p.001067: contracts under section 338B.
p.001067: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
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p.001067: (b) ELIGIBILITY.—
p.001067: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ indicates an accredited educational institution that
p.001067: offers a course of study, certificate program, or professional training program in
p.001067: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001067: public or allied health or a related discipline, as determined by the Secretary
p.001067: (2) ELIGIBLE INDIVIDUALS.—The term ‘‘eligible individuals’’ includes those individuals employed in public and allied
p.001067: health positions at the Federal, State, tribal, or local level who are in- terested in retaining or upgrading their
p.001067: education.
p.001067: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001067: $60,000,000 for fiscal year 2010 and such sums as may be necessary for each of fiscal years 2011 through
p.001067: 2015. Fifty percent of appropriated funds shall be allotted to public health mid-career professionals and 50 percent
p.001067: shall be allotted to allied health mid-career professionals.
p.001067: SEC. 778. ø295f–3¿ FELLOWSHIP TRAINING IN APPLIED PUBLIC HEALTH EPIDEMIOLOGY, PUBLIC HEALTH
p.001067: LABORATORY SCIENCE, PUBLIC HEALTH INFORMATICS, AND EXPAN- SION OF THE EPIDEMIC INTELLIGENCE SERVICE.
p.001067: (a) IN GENERAL.—The Secretary may carry out activities to ad- dress documented workforce shortages in State and local
p.001067: health de- partments in the critical areas of applied public health epidemi- ology and public health
p.001067: laboratory science and informatics and may expand the Epidemic Intelligence Service.
p.001067: (b) SPECIFIC USES.—In carrying out subsection (a), the Sec- retary shall provide for the expansion of
p.001067: existing fellowship pro- grams operated through the Centers for Disease Control and Pre- vention in a
p.001067: manner that is designed to alleviate shortages of the type described in subsection (a).
p.001067: (c) OTHER PROGRAMS.—The Secretary may provide for the ex- pansion of other applied epidemiology training
p.001067: programs that meet objectives similar to the objectives of the programs described in subsection (b).
p.001067: (d) WORK OBLIGATION.—Participation in fellowship training programs under this section shall be deemed to be
p.001067: service for pur- poses of satisfying work obligations stipulated in contracts under section 338I(j).
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p.001069: (1) the Secretary enters into agreements with individuals to make payments in accordance with subsection
p.001069: (b) on the principal of and interest on any eligible loan; and
p.001069: (2) the individuals each agree to the requirements of serv- ice in substance use disorder treatment employment,
p.001069: as de- scribed in subsection (d).
p.001069: (b) PAYMENTS.—For each year of obligated service by an indi- vidual pursuant to an agreement under
p.001069: subsection (a), the Sec- retary shall make a payment to such individual as follows:
p.001069: (1) SERVICE IN A SHORTAGE AREA.—The Secretary shall pay—
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p.001069: (A) for each year of obligated service by an individual pursuant to an agreement under subsection (a), 1⁄6 of
p.001069: the principal of and interest on each eligible loan of the indi- vidual which is outstanding on the
p.001069: date the individual began service pursuant to the agreement; and
p.001069: (B) for completion of the sixth and final year of such service, the remainder of such principal and interest.
p.001069: (2) MAXIMUM AMOUNT.—The total amount of payments under this section to any individual shall not exceed $250,000.
p.001069: (c) ELIGIBLE LOANS.—The loans eligible for repayment under this section are each of the following:
p.001069: (1) Any loan for education or training for a substance use disorder treatment employment.
p.001069: (2) Any loan under part E of title VIII (relating to nursing student loans).
p.001069: (3) Any Federal Direct Stafford Loan, Federal Direct PLUS Loan, Federal Direct Unsubsidized Stafford Loan, or
p.001069: Federal Direct Consolidation Loan (as such terms are used in section 455 of the Higher Education Act of 1965).
p.001069: (4) Any Federal Perkins Loan under part E of title I of the Higher Education Act of 1965.
p.001069: (5) Any other Federal loan as determined appropriate by the Secretary.
p.001069: (d) REQUIREMENTS OF SERVICE.—Any individual receiving pay- ments under this program as required by an agreement under
p.001069: sub- section (a) shall agree to an annual commitment to full-time em- ployment, with no more than 1
p.001069: year passing between any 2 years of covered employment, in substance use disorder treatment em- ployment
p.001069: in the United States in—
p.001069: (1) a Mental Health Professional Shortage Area, as des- ignated under section 332; or
p.001069: (2) a county (or a municipality, if not contained within any county) where the mean drug overdose death rate per
p.001069: 100,000 people over the past 3 years for which official data is available from the State, is higher than the
p.001069: most recent available na-
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001069: tional average overdose death rate per 100,000 people, as re- ported by the Centers for Disease Control and
p.001069: Prevention.
p.001069: (e) INELIGIBILITY FOR DOUBLE BENEFITS.—No borrower may, for the same service, receive a reduction of
p.001069: loan obligations or a loan repayment under both—
p.001069: (1) this section; and
p.001069: (2) any Federally supported loan forgiveness program, in- cluding under section 338B, 338I, or 846 of this Act,
p.001069: or section 428J, 428L, 455(m), or 460 of the Higher Education Act of 1965.
p.001069: (f) BREACH.—
p.001069: (1) LIQUIDATED DAMAGES FORMULA.—The Secretary may establish a liquidated damages formula to be used in the event
p.001069: of a breach of an agreement entered into under subsection (a).
p.001069: (2) LIMITATION.—The failure by an individual to complete the full period of service obligated pursuant to
p.001069: such an agree- ment, taken alone, shall not constitute a breach of the agree- ment, so long as the
p.001069: individual completed in good faith the years of service for which payments were made to the indi- vidual
p.001069: under this section.
p.001069: (g) ADDITIONAL CRITERIA.—The Secretary—
p.001069: (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed
p.001069: and in addition to the criteria and rules specified in this section; and
p.001069: (2) shall give notice to the committees specified in sub- section (h) of any criteria and rules so
p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001071: or certified in accordance with applicable State and Fed- eral laws; and
p.001071: (B) which is located at a substance use disorder treat- ment program, private physician practice, hospital
p.001071: or health system-affiliated inpatient treatment center or out- patient clinic (including an academic medical
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p.001079: equivalent degree and a doctoral degree in clinical psychology or an equivalent degree.
p.001079: (C) The terms ‘‘graduate program in clinical social work’’ and ‘‘graduate program in marriage and family
p.001079: therapy’’ and ‘‘graduate program in professional counseling’’ mean an accred- ited graduate program in a public or
p.001079: nonprofit private institu- tion in a State that provides training, respectively, in a con- centration in
p.001079: health or mental health care leading to a grad- uate degree in social work and a concentration leading
p.001079: to a graduate degree in marriage and family therapy and a con- centration leading to a graduate degree in
p.001079: counseling.
p.001079: (D) 24 The term ‘‘graduate program in behavioral health and mental health practice’’ means a graduate program
p.001079: in clin- ical psychology, clinical social work, professional counseling, or marriage and family therapy.
p.001079: (E) The term ‘‘accredited’’, when applied to a school of medicine, osteopathic medicine, dentistry, veterinary
p.001079: medicine, optometry, podiatry, pharmacy, public health, or chiropractic, or a graduate program in health
p.001079: administration, clinical psy- chology, clinical social work, professional counseling, or mar- riage and
p.001079: family therapy, means a school or program that is accredited by a recognized body or bodies approved
p.001079: for such purpose by the Secretary of Education, except that a new school or program that, by reason of
p.001079: an insufficient period of operation, is not, at the time of application for a grant or con- tract under this title,
p.001079: eligible for accreditation by such a recog- nized body or bodies, shall be deemed accredited for purposes of
p.001079: this title, if the Secretary of Education finds, after consulta- tion with the appropriate accreditation body or
p.001079: bodies, that there is reasonable assurance that the school or program will meet the accreditation
p.001079: standards of such body or bodies prior to the beginning of the academic year following the normal
p.001079: graduation date of the first entering class in such school or program.
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p.001079: January 30, 2020
p.001079: 24 Section 108(a)(2) of Public Law 105–392 (112 Stat. 3560) provides that paragraph (1)(D) is amended by inserting
p.001079: ‘‘behavioral health and mental health practice,’’ before ‘‘clinical’’. The amendment cannot be executed
p.001079: because the amendment does not specify to which instance of the term ‘‘clinical’’ the amendment applies.
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001079: Sec. 799B PUBLIC HEALTH SERVICE ACT 1080
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p.001079: (2) The term ‘‘teaching facilities’’ means areas dedicated for use by students, faculty, or administrative
p.001079: or maintenance personnel for clinical purposes, research activities, libraries, classrooms, offices,
p.001079: auditoriums, dining areas, student activi- ties, or other related purposes necessary for, and appropriate
p.001079: to, the conduct of comprehensive programs of education. Such term includes interim facilities but does not
p.001079: include off-site im- provements or living quarters.
p.001079: (3) PHYSICIAN ASSISTANT EDUCATION PROGRAM.—The term ‘‘physician assistant education program’’ means an educational
p.001079: program in a public or private institution in a State that—
p.001079: (A) has as its objective the education of individuals who, upon completion of their studies in the
p.001079: program, be qualified to provide primary care medical services with the supervision of a physician; and
p.001079: (B) is accredited by the Accreditation Review Commis- sion on Education for the Physician Assistant.
p.001079: (4) The term ‘‘school of allied health’’ means a public or nonprofit private college, junior college, or
p.001079: university or hos- pital-based educational entity that—
p.001079: (A) provides, or can provide, programs of education to enable individuals to become allied health professionals or to
p.001079: provide additional training for allied health profes- sionals;
p.001079: (B) provides training for not less than a total of twenty persons in the allied health curricula (except that this sub-
p.001079: paragraph shall not apply to any hospital-based edu- cational entity);
p.001079: (C) includes or is affiliated with a teaching hospital;
p.001079: and
p.001079: (D) is accredited by a recognized body or bodies ap-
p.001079: proved for such purposes by the Secretary of Education, or which provides to the Secretary satisfactory assurance
p.001079: by such accrediting body or bodies that reasonable progress is being made toward accreditation.
p.001079: (5) The term ‘‘allied health professionals’’ means a health professional (other than a registered nurse or
p.001079: physician assist- ant)—
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p.001079: (A) who has received a certificate, an associate’s de- gree, a bachelor’s degree, a master’s degree, a doctoral
p.001079: de- gree, or postbaccalaureate training, in a science relating to health care;
p.001079: (B) who shares in the responsibility for the delivery of health care services or related services, including—
p.001079: (i) services relating to the identification, evalua- tion, and prevention of disease and disorders;
p.001079: (ii) dietary and nutrition services;
p.001079: (iii) health promotion services;
p.001079: (iv) rehabilitation services; or
p.001079: (v) health systems management services; and
p.001079: (C) who has not received a degree of doctor of medi- cine, a degree of doctor of osteopathy, a degree
p.001079: of doctor of dentistry or an equivalent degree, a degree of doctor of veterinary medicine or an
p.001079: equivalent degree, a degree of
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p.001081: relative to the number of individuals who are members of the population involved.
p.001081: (B) For purposes of subparagraph (A), Asian individuals shall be considered by the various subpopulations of
p.001081: such indi- viduals.
p.001081: (11) The term ‘‘psychologist’’ means an individual who—
p.001081: (A) holds a doctoral degree in psychology; and
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p.001081: 25 The reference in paragraph (6)(B) to section 329 refers to section 329 of the Act of July 1, 1944,
p.001081: which was omitted in the general amendment of subpart I of part D of this title by section 2 of Public Law 104-299
p.001081: (110 Stat. 3626; October 11, 1996). Section 340A, referred to in para- graph (6)(B), was repealed by section
p.001081: 4(a)(3) of Public Law 104-299.
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p.001081: (B) is licensed or certified on the basis of the doctoral degree in psychology, by the State in which the individual
p.001081: practices, at the independent practice level of psychology to furnish diagnostic, assessment, preventive,
p.001081: and thera- peutic services directly to individuals.
p.001081: (12) AREA HEALTH EDUCATION CENTER.—The term ‘‘area health education center’’ means a public or
p.001081: nonprofit private organization that has a cooperative agreement or contract in effect with an entity that
p.001081: has received an award under sub- section (a)(1) or (a)(2) of section 751, satisfies the requirements in section
p.001081: 751(d)(1), and has as one of its principal functions the operation of an area health education center.
p.001081: Appropriate organizations may include hospitals, health organizations with accredited primary care training
p.001081: programs, accredited physi- cian assistant educational programs associated with a college or university,
p.001081: and universities or colleges not operating a school of medicine or osteopathic medicine.
p.001081: (13) AREA HEALTH EDUCATION CENTER PROGRAM.—The term ‘‘area health education center program’’ means
p.001081: coopera- tive program consisting of an entity that has received an award under subsection (a)(1) or
p.001081: (a)(2) of section 751 for the purpose of planning, developing, operating, and evaluating an area health
p.001081: education center program and one or more area health education centers, which carries out the required activi-
p.001081: ties described in section 751(c), satisfies the program require- ments in such section, has as one of
p.001081: its principal functions identifying and implementing strategies and activities that ad- dress health care workforce
p.001081: needs in its service area, in coordi- nation with the local workforce investment boards.
p.001081: (14) CLINICAL SOCIAL WORKER.—The term ‘‘clinical social worker’’ has the meaning given the term in section
p.001081: 1861(hh)(1) of the Social Security Act (42 U.S.C. 1395x(hh)(1)).
p.001081: (15) CULTURAL COMPETENCY.—The term ‘‘cultural com- petency’’ shall be defined by the Secretary in a
p.001081: manner con- sistent with section 1707(d)(3).
p.001081: (16) DIRECT CARE WORKER.—The term ‘‘direct care worker’’ has the meaning given that term in the 2010
p.001081: Standard Occu- pational Classifications of the Department of Labor for Home Health Aides [31–1011],
p.001081: Psychiatric Aides [31–1013], Nursing Assistants [31–1014], and Personal Care Aides [39–9021].
p.001081: (17) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001081: given that term in section 1861(aa) of the Social Security Act (42 U.S.C. 1395x(aa)).
p.001081: (18) FRONTIER HEALTH PROFESSIONAL SHORTAGE AREA.— The term ‘‘frontier health professional shortage area’’
p.001081: means an area—
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p.001081: (A) with a population density less than 6 persons per square mile within the service area; and
p.001081: (B) with respect to which the distance or time for the population to access care is excessive.
p.001081: (19) GRADUATE PSYCHOLOGY.—The term ‘‘graduate psy- chology’’ means an accredited program in
p.001081: professional psy- chology.
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p.001083: Sec. 801
p.001083:
p.001083: (20) HEALTH DISPARITY POPULATION.—The term ‘‘health disparity population’’ has the meaning given such term in
p.001083: sec- tion 903(d)(1).
p.001083: (21) HEALTH LITERACY.—The term ‘‘health literacy’’ means the degree to which an individual has the capacity
p.001083: to obtain, communicate, process, and understand health information and services in order to make appropriate health
p.001083: decisions.
p.001083: (22) MENTAL HEALTH SERVICE PROFESSIONAL.—The term ‘‘mental health service professional’’ means an
p.001083: individual with a graduate or postgraduate degree from an accredited institu- tion of higher education in
p.001083: psychiatry, psychology, school psy- chology, behavioral pediatrics, psychiatric nursing, social work, school social
p.001083: work, substance abuse disorder prevention and treatment, marriage and family counseling, school counseling,
p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
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p.001083: 2864(c))’’ and insert ‘‘one-stop delivery system described in section 121(e) of the Workforce Innovation and
p.001083: Opportunity Act’’.
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p.001083: (2) SCHOOL OF NURSING.—The term ‘‘school of nursing’’ means an accredited (as defined in paragraph 6)
p.001083: collegiate, as- sociate degree, or diploma school of nursing in a State where graduates are—
p.001083: (A) authorized to sit for the National Council Licen- sure EXamination-Registered Nurse (NCLEX–RN); or
p.001083: (B) licensed registered nurses who will receive a grad- uate or equivalent degree or training to become an ad-
p.001083: vanced education nurse as defined by section 811(b).
p.001083: (3) COLLEGIATE SCHOOL OF NURSING.—The term ‘‘collegiate school of nursing’’ means a department, division, or
p.001083: other ad- ministrative unit in a college or university which provides pri- marily or exclusively a program of
p.001083: education in professional nursing and related subjects leading to the degree of bachelor of arts, bachelor
p.001083: of science, bachelor of nursing, or to an equiv- alent degree, or to a graduate degree in nursing, or to an
p.001083: equivalent degree, and including advanced training related to such program of education provided by such school,
p.001083: but only if such program, or such unit, college or university is accredited.
p.001083: (4) ASSOCIATE DEGREE SCHOOL OF NURSING.—The term ‘‘as- sociate degree school of nursing’’ means a department,
p.001083: division, or other administrative unit in a junior college, community col- lege, college, or university which
p.001083: provides primarily or exclu- sively a two-year program of education in professional nursing and allied subjects
p.001083: leading to an associate degree in nursing or to an equivalent degree, but only if such program, or such unit, college,
p.001083: or university is accredited.
p.001083: (5) DIPLOMA SCHOOL OF NURSING.—The term ‘‘diploma school of nursing’’ means a school affiliated
p.001083: with a hospital or university, or an independent school, which provides primarily or exclusively a program of
p.001083: education in professional nursing and allied subjects leading to a diploma or to equivalent indicia that such
p.001083: program has been satisfactorily completed, but only if such program, or such affiliated school or such
p.001083: hospital or university or such independent school is accredited.
p.001083: (6) ACCREDITED.—
p.001083: (A) IN GENERAL.—Except as provided in subparagraph (B), the term ‘‘accredited’’ when applied to any program of nurse
p.001083: education means a program accredited by a recog- nized body or bodies, or by a State agency, approved
p.001083: for such purpose by the Secretary of Education and when ap- plied to a hospital, school, college, or university (or a
p.001083: unit thereof) means a hospital, school, college, or university (or a unit thereof) which is accredited by a recognized
p.001083: body or bodies, or by a State agency, approved for such purpose by the Secretary of Education. For the purpose
p.001083: of this para- graph, the Secretary of Education shall publish a list of recognized accrediting bodies, and
p.001083: of State agencies, which the Secretary of Education determines to be reliable au- thority as to the quality of
p.001083: education offered.
p.001083: (B) NEW PROGRAMS.—A new program of nursing that, by reason of an insufficient period of operation, is
p.001083: not, at the time of the submission of an application for a grant or contract under this title, eligible for
p.001083: accreditation by such
p.001083: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001085: 1085
p.001085: PUBLIC HEALTH SERVICE ACT
p.001085: Sec. 801
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p.001085: a recognized body or bodies or State agency, shall be deemed accredited for purposes of this title if the
p.001085: Secretary of Education finds, after consultation with the appropriate accreditation body or bodies, that there is
p.001085: reasonable as- surance that the program will meet the accreditation standards of such body or bodies
p.001085: prior to the beginning of the academic year following the normal graduation date of students of the first entering
p.001085: class in such a program.
p.001085: (7) NONPROFIT.—The term ‘‘nonprofit’’ as applied to any school, agency, organization, or institution means one
p.001085: which is a corporation or association, or is owned and operated by one or more corporations or
p.001085: associations, no part of the net earn- ings of which inures, or may lawfully inure, to the benefit of
p.001085: any private shareholder or individual.
p.001085: (8) STATE.—The term ‘‘State’’ means a State, the Common- wealth of Puerto Rico, the District of Columbia, the
p.001085: Common- wealth of the Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, or the Trust Territory
p.001085: of the Pacific Islands.
p.001085: (9) AMBULATORY SURGICAL CENTER.—The term ‘‘ambula- tory surgical center’’ has the meaning applicable to
p.001085: such term under title XVIII of the Social Security Act.
p.001085: (10) FEDERALLY QUALIFIED HEALTH CENTER.—The term ‘‘Federally qualified health center’’ has the meaning
p.001085: given such term under section 1861(aa)(4) of the Social Security Act.
p.001085: (11) HEALTH CARE FACILITY.—The term ‘‘health care facil- ity’’ means an Indian Health Service health
p.001085: center, a Native Hawaiian health center, a hospital, a Federally qualified health center, a rural
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p.001085: such term in section 1819(a) of the Social Security Act.
p.001085: (16) ACCELERATED NURSING DEGREE PROGRAM.—The term ‘‘accelerated nursing degree program’’ means a program of edu-
p.001085: cation in professional nursing offered by an accredited school of nursing in which an individual holding
p.001085: a bachelors degree in another discipline receives a BSN or MSN degree in an ac- celerated time frame as
p.001085: determined by the accredited school of nursing.
p.001085: (17) BRIDGE OR DEGREE COMPLETION PROGRAM.—The term ‘‘bridge or degree completion program’’ means a program
p.001085: of
p.001085: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001085: Sec. 802 PUBLIC HEALTH SERVICE ACT 1086
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p.001085: January 30, 2020
p.001085:
p.001085: education in professional nursing offered by an accredited school of nursing, as defined in
p.001085: paragraph (2), that leads to a baccalaureate degree in nursing. Such programs may include, Registered
p.001085: Nurse (RN) to Bachelor’s of Science of Nursing (BSN) programs, RN to MSN (Master of Science of Nursing)
p.001085: programs, or BSN to Doctoral programs.
p.001085: SEC. 802. ø296a¿ APPLICATION.
p.001085: (a) IN GENERAL.—To be eligible to receive a grant or contract under this title, an eligible entity
p.001085: shall prepare and submit to the Secretary an application that meets the requirements of this sec- tion,
p.001085: at such time, in such manner, and containing such informa- tion as the Secretary may require.
p.001085: (b) PLAN.—An application submitted under this section shall contain the plan of the applicant for
p.001085: carrying out a project with amounts received under this title. Such plan shall be consistent with relevant
p.001085: Federal, State, or regional program plans.
p.001085: (c) PERFORMANCE OUTCOME STANDARDS.—An application sub- mitted under this section shall contain a specification
p.001085: by the appli- cant entity of performance outcome standards that the project to be funded under the grant or contract
p.001085: will be measured against. Such standards shall address relevant national nursing needs that the project will
p.001085: meet. The recipient of a grant or contract under this section shall meet the standards set forth in
p.001085: the grant or contract application.
p.001085: (d) LINKAGES.—An application submitted under this section shall contain a description of the linkages with
p.001085: relevant edu- cational and health care entities, including training programs for other health professionals
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p.001087: peer review group has recommended the application for approval.
p.001087: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001087: are
p.001087: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001087: Sec. 807 PUBLIC HEALTH SERVICE ACT 1088
p.001087:
p.001087: not officers or employees of the Federal Government. In pro- viding for the establishment of peer review
p.001087: groups and proce- dures, the Secretary shall, except as otherwise provided, en- sure sex, racial, ethnic,
p.001087: and geographic representation among the membership of such groups.
p.001087: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001087: Administrator of the Health Resources and Services Administration.
p.001087: (f) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001087: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001087: analysis activities under this title; and
p.001087: (2) discipline-specific workforce information is developed and analytical activities are carried out as part of—
p.001087: (A) the advanced education nursing activities under part B;
p.001087: (B) the workforce diversity activities under part C;
p.001087: and
p.001087: (C) basic nursing education and practice activities
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p.001087: under part D.
p.001087: (g) STATE AND REGIONAL PRIORITIES.—Activities under grants or contracts under this title shall, to the
p.001087: extent practicable, be con- sistent with related Federal, State, or regional nursing professions program plans and
p.001087: priorities.
p.001087: (h) FILING OF APPLICATIONS.—
p.001087: (1) IN GENERAL.—Applications for grants or contracts under this title may be submitted by
p.001087: health professions schools, schools of nursing, academic health centers, State or local governments, or
p.001087: other appropriate public or private non- profit entities as determined appropriate by the Secretary in
p.001087: accordance with this title.
p.001087: (2) FOR-PROFIT ENTITIES.—Notwithstanding paragraph (1), a for-profit entity may be eligible for a grant or
p.001087: contract under this title as determined appropriate by the Secretary.
p.001087: SEC. 807. ø296e–1¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001087: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—The Secretary,
p.001087: acting through the Administrator of the Health Resources and Services Administration, may make awards of
p.001087: grants, contracts, or coopera- tive agreements to eligible entities for the development, evaluation, and dissemination
p.001087: of research, demonstration projects, and model curricula for cultural competency, prevention, public health
p.001087: pro- ficiency, reducing health disparities, and aptitude for working with individuals with disabilities training
p.001087: for use in health professions schools and continuing education programs, and for other purposes determined as
p.001087: appropriate by the Secretary. Grants under this sec- tion shall be the same as provided in section 741.
p.001087: (b) COLLABORATION.—In carrying out subsection (a), the Sec- retary shall collaborate with the entities
p.001087: described in section 741(b). The Secretary shall coordinate with curricula and research and demonstration
p.001087: projects developed under such section 741.
p.001087: (c) DISSEMINATION.—Model curricula developed under this sec- tion shall be disseminated and evaluated in the
p.001087: same manner as
p.001087: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001089: 1089
p.001089: PUBLIC HEALTH SERVICE ACT
p.001089: Sec. 811
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p.001089: model curricula developed under section 741, as described in sub- section (c) of such section.
p.001089: (d) AUTHORIZATION OF APPROPRIATIONS.—There are to be ap- propriated to carry out this section such sums as may
p.001089: be necessary for each of the fiscal years 2010 through 2015.
p.001089: SEC. 808. ø296f¿ TECHNICAL ASSISTANCE.
p.001089: Funds appropriated under this title may be used by the Sec- retary to provide technical assistance in
p.001089: relation to any of the au- thorities under this title.
p.001089:
p.001089: PROHIBITION AGAINST DISCRIMINATION BY SCHOOLS ON THE BASIS OF SEX
p.001089: SEC. 809. ø296g¿ The Secretary may not make a grant, loan guarantee, or interest subsidy payment under
p.001089: this title to, or for the benefit of, any school of nursing unless the application for the grant, loan
p.001089: guarantee, or interest subsidy payment contains assur- ances satisfactory to the Secretary that the school will not
p.001089: discrimi- nate on the basis of sex in the admission of individuals to its train- ing programs. The Secretary may
p.001089: not enter into a contract under this title with any school unless the school furnishes assurances
p.001089: satisfactory to the Secretary that it will not discriminate on the basis of sex in the admission of
p.001089: individuals to its training pro- grams.
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p.001089: PART B—NURSE PRACTITIONERS, NURSE MID- WIVES, NURSE ANESTHETISTS, AND OTHER ADVANCED EDUCATION NURSES
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p.001089: SEC. 811. ø296j¿ ADVANCED EDUCATION NURSING GRANTS.
p.001089: (a) IN GENERAL.—The Secretary may award grants to and enter into contracts with eligible entities to meet the
p.001089: costs of—
p.001089: (1) projects that support the enhancement of advanced nursing education and practice; and
p.001089: (2) traineeships for individuals in advanced nursing edu- cation programs.
p.001089: (b) DEFINITION OF ADVANCED EDUCATION NURSES.—For pur- poses of this section, the term ‘‘advanced education
p.001089: nurses’’ means individuals trained in advanced degree programs including individ- uals in combined R.N./Master’s degree
p.001089: programs, post-nursing mas- ter’s certificate programs, or, in the case of nurse midwives, in cer- tificate programs
p.001089: in existence on the date that is one day prior to the date of enactment of this section, to serve as
p.001089: nurse practi- tioners, clinical nurse specialists, nurse midwives, nurse anes- thetists, nurse
p.001089: educators, nurse administrators, or public health nurses, or in other nurse specialties determined by the
p.001089: Secretary to require advanced education.
p.001089: (c) AUTHORIZED NURSE PRACTITIONER.—Nurse practitioner pro- grams eligible for support under this section are
p.001089: educational pro- grams for registered nurses (irrespective of the type of school of nursing in which the
p.001089: nurses received their training) that—
p.001089: (1) meet guidelines prescribed by the Secretary; and
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p.001089: (2) have as their objective the education of nurses who will upon completion of their studies in such programs, be
p.001089: qualified to effectively provide primary health care, including primary health care in homes and in
p.001089: ambulatory care facilities, long- term care facilities, acute care, and other health care settings.
p.001089: (d) AUTHORIZED NURSE-MIDWIFERY PROGRAMS.—Midwifery pro- grams that are eligible for support under this
p.001089: section are edu- cational programs that—
p.001089: (1) have as their objective the education of midwives; and
p.001089: (2) are accredited by the American College of Nurse-Mid- wives Accreditation Commission for Midwifery
p.001089: Education.
p.001089: (e) AUTHORIZED NURSE ANESTHESIA PROGRAMS.—Nurse anes- thesia programs eligible for support under this
p.001089: section are edu- cation programs that—
p.001089: (1) provide registered nurses with full-time anesthetist education; and
p.001089: (2) are accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs.
p.001089: (f) OTHER AUTHORIZED EDUCATIONAL PROGRAMS.—The Sec- retary shall prescribe guidelines as appropriate for
p.001089: other advanced nurse education programs eligible for support under this section.
p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
p.001089: the costs of special projects to increase nursing education opportunities for individuals who are from
p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
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p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
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p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
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p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
p.001091: associations including the National Coalition of Eth- nic Minority Nurse Associations, American Nurses
p.001091: Association, the National League for Nursing, the American Association of Colleges of Nursing, the National Black
p.001091: Nurses Association, the National Association of Hispanic Nurses, the Association of Asian American and Pacific
p.001091: Islander Nurses, the Native American Indian and Alas- kan Nurses Association, and the National Council of State
p.001091: Boards of Nursing, and other organizations determined appropriate by the Secretary.
p.001091: (c) REQUIRED INFORMATION AND CONDITIONS FOR AWARD RE-
p.001091: CIPIENTS.—
p.001091: (1) IN GENERAL.—Recipients of awards under this section may be required, where requested, to report to
p.001091: the Secretary concerning the annual admission, retention, and graduation rates for individuals from
p.001091: disadvantaged backgrounds and eth- nic and racial minorities in the school or schools involved in the
p.001091: projects.
p.001091: (2) FALLING RATES.—If any of the rates reported under paragraph (1) fall below the average of the two previous
p.001091: years, the grant or contract recipient shall provide the Secretary with plans for immediately improving such rates.
p.001091: (3) INELIGIBILITY.—A recipient described in paragraph (2) shall be ineligible for continued funding under
p.001091: this section if the plan of the recipient fails to improve the rates within the 1-year period beginning on
p.001091: the date such plan is implemented.
p.001091:
p.001091: PART D—STRENGTHENING CAPACITY FOR BASIC NURSE EDUCATION AND PRACTICE
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p.001091: SEC. 831. ø296p¿ NURSE EDUCATION, PRACTICE, AND QUALITY GRANTS.
p.001091: (a) EDUCATION PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: for—
p.001091: (1) expanding the enrollment in baccalaureate nursing pro- grams; or
p.001091: (2) providing education in new technologies, including dis- tance learning methodologies.
p.001091: (b) PRACTICE PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible
p.001091: entities for—
p.001091: (1) establishing or expanding nursing practice arrange- ments in noninstitutional settings to demonstrate
p.001091: methods to improve access to primary health care in medically under- served communities;
p.001091: (2) providing care for underserved populations and other high-risk groups such as the elderly, individuals
p.001091: with HIV/ AIDS, substance abusers, the homeless, and victims of domes- tic violence;
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001091: (3) providing coordinated care, and other skills needed to practice in existing and emerging organized
p.001091: health care sys- tems; or
p.001091: (4) developing cultural competencies among nurses.
p.001091: (c) RETENTION PRIORITY AREAS.—The Secretary may award grants to and enter into contracts with eligible entities
p.001091: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to paragraph
p.001091: (1) or (2).
p.001091: (1) GRANTS FOR CAREER LADDER PROGRAMS.—The Sec- retary may award grants to and enter into contracts
p.001091: with eligi- ble entities for programs—
p.001091: (A) to promote career advancement for nursing per- sonnel in a variety of training settings, cross
p.001091: training or specialty training among diverse population groups, and the advancement of individuals including to
p.001091: become profes- sional nurses, advanced education nurses, licensed prac- tical nurses, certified nurse
p.001091: assistants, and home health aides; and
p.001091: (B) to assist individuals in obtaining education and training required to enter the nursing profession
p.001091: and ad- vance within such profession, such as by providing career counseling and mentoring.
p.001091: (2) ENHANCING PATIENT CARE DELIVERY SYSTEMS.—
p.001091: (A) GRANTS.—The Secretary may award grants to eli- gible entities to improve the retention of nurses and
p.001091: en- hance patient care that is directly related to nursing ac- tivities by enhancing collaboration
p.001091: and communication among nurses and other health care professionals, and by promoting nurse involvement in
p.001091: the organizational and clinical decisionmaking processes of a health care facility.
p.001091: (B) PREFERENCE.—In making awards of grants under this paragraph, the Secretary shall give a preference to ap-
p.001091: plicants that have not previously received an award under this paragraph.
p.001091: (C) CONTINUATION OF AN AWARD.—The Secretary shall make continuation of any award under this paragraph be- yond the
p.001091: second year of such award contingent on the re- cipient of such award having demonstrated to the Sec-
p.001091: retary measurable and substantive improvement in nurse retention or patient care.
p.001091: (d) OTHER PRIORITY AREAS.—The Secretary may award grants to or enter into contracts with eligible entities
p.001091: to address other areas that are of high priority to nurse education, practice, and re- tention, as determined by the
p.001091: Secretary.
p.001091: (e) PREFERENCE.—For purposes of any amount of funds appro- priated to carry out this section for fiscal year 2003,
p.001091: 2004, or 2005 that is in excess of the amount of funds appropriated to carry out this section for fiscal
p.001091: year 2002, the Secretary shall give preference to awarding grants or entering into contracts under subsections
p.001091: (a)(2) and (c).
p.001091: (f) REPORT.—The Secretary shall submit to the Congress before the end of each fiscal year a report on the grants
p.001091: awarded and the contracts entered into under this section. Each such report shall identify the overall
p.001091: number of such grants and contracts and pro-
p.001091: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001091:
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p.001093: 1093
p.001093: PUBLIC HEALTH SERVICE ACT
p.001093: Sec. 831A
p.001093:
p.001093: vide an explanation of why each such grant or contract will meet the priority need of the nursing workforce.
p.001093: (g) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ includes a school of
p.001093: nursing, as defined in section 801(2),, 2 a health care facility, or a partnership of such a school and
p.001093: facility.
p.001093: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001093: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001093: SEC. 831A. ø296p–1¿ NURSE RETENTION GRANTS.
p.001093: (a) RETENTION PRIORITY AREAS.—The Secretary may award grants to, and enter into contracts with, eligible entities
p.001093: to enhance the nursing workforce by initiating and maintaining nurse reten- tion programs pursuant to
p.001093: subsection (b) or (c).
p.001093: (b) GRANTS FOR CAREER LADDER PROGRAM.—The Secretary may award grants to, and enter into contracts with,
p.001093: eligible entities for programs—
p.001093: (1) to promote career advancement for individuals includ- ing licensed practical nurses, licensed
p.001093: vocational nurses, cer- tified nurse assistants, home health aides, diploma degree or associate degree
p.001093: nurses, to become baccalaureate prepared reg- istered nurses or advanced education nurses in order to meet the
p.001093: needs of the registered nurse workforce;
p.001093: (2) developing and implementing internships and residency programs in collaboration with an accredited school of
p.001093: nursing, as defined by section 801(2), to encourage mentoring and the development of specialties; or
p.001093: (3) to assist individuals in obtaining education and train- ing required to enter the nursing profession and
p.001093: advance with- in such profession.
p.001093: (c) ENHANCING PATIENT CARE DELIVERY SYSTEMS.—
p.001093: (1) GRANTS.—The Secretary may award grants to eligible entities to improve the retention of nurses and enhance
p.001093: patient care that is directly related to nursing activities by enhancing collaboration and communication among
p.001093: nurses and other health care professionals, and by promoting nurse involvement in the organizational and clinical
p.001093: decision-making processes of a health care facility.
p.001093: (2) PRIORITY.—In making awards of grants under this sub- section, the Secretary shall give preference to
p.001093: applicants that have not previously received an award under this subsection (or section 831(c) as such section
p.001093: existed on the day before the date of enactment of this section).
p.001093: (3) CONTINUATION OF AN AWARD.—The Secretary shall make continuation of any award under this subsection
p.001093: beyond the second year of such award contingent on the recipient of such award having demonstrated to
p.001093: the Secretary measurable and substantive improvement in nurse retention or patient care.
p.001093: (d) OTHER PRIORITY AREAS.—The Secretary may award grants to, or enter into contracts with, eligible entities
p.001093: to address other
p.001093:
p.001093:
p.001093:
p.001093: January 30, 2020
p.001093: 2 So in law.
p.001093:
p.001093: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001093:
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p.001093: (1) provide for establishment of a student loan fund by the school;
p.001093: (2) provide for deposit in the fund, except as provided in section 871, of (A) the Federal capital
p.001093: contributions paid from allotments under section 838 to the school by the Secretary, (B) an additional amount from
p.001093: other sources equal to not less than one-ninth of such Federal capital contributions, (C) collections of
p.001093: principal and interest on loans made from the fund, (D) col- lections pursuant to section 836(f), and (E) any other
p.001093: earnings of the fund;
p.001093: (3) provide that the fund, except as provided in section 871, shall be used only for loans to students
p.001093: of the school in accordance with the agreement and for costs of collection of such loans and interest
p.001093: thereon;
p.001093: (4) provide that loans may be made from such fund only to students pursuing a full-time or half-time course
p.001093: of study at the school leading to a baccalaureate or associate degree in nursing or an equivalent degree or a
p.001093: diploma in nursing, or to a graduate degree in nursing; and
p.001093:
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p.001093: January 30, 2020
p.001093: 3 Section 936(e) of Public Law 94–63 repealed a section of this title that provided for a revolv- ing fund. This former
p.001093: section was section 827. With respect to the revolving fund, such section 936(e) provided as follows: ‘‘The nurse
p.001093: training fund created within the Treasury by section 827(d)(1) of the Act shall remain available to the
p.001093: Secretary of Health, Education, and Welfare for the purpose of meeting his responsibilities respecting
p.001093: participations in obligations acquired under section 827 of the Act. The Secretary shall continue to deposit in such
p.001093: fund all amounts received by him as interest payments or repayments of principal on loans under such
p.001093: section 827. If at any time the Secretary determines the moneys in the funds exceed the present and any
p.001093: reasonable prospective further requirements of such fund, such excess may be transferred to the general
p.001093: fund of the Treasury.’’. Such section further provided that ‘‘[t]here are authorized to be appropriated without
p.001093: fiscal year limitation such sums as may be necessary to enable the Secretary to make payments under
p.001093: agreements entered into under section 827(b) of the Act be- fore øJuly 27, 1975¿’’.
p.001093: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001093:
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p.001095: 1095
p.001095: PUBLIC HEALTH SERVICE ACT
p.001095: Sec. 836
p.001095:
p.001095: (5) contain such other provisions as are necessary to pro- tect the financial interests of the United States.
p.001095: (c)(1) Any standard established by the Secretary by regulation for the collection by schools of nursing of
p.001095: loans made pursuant to loan agreements under this part shall provide that the failure of any such school
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p.001103: 1103
p.001103: PUBLIC HEALTH SERVICE ACT
p.001103: Sec. 846
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p.001103: January 30, 2020
p.001103: (e) PREFERENCES REGARDING PARTICIPANTS.—In entering into agreements under subsection (a) or (d), the
p.001103: Secretary shall give preference to qualified applicants with the greatest financial need.
p.001103: (f) BREACH OF AGREEMENT.—The Secretary may make pay- ments under subsection (a) on behalf of an
p.001103: individual only if the agreement under such subsection provides that section 860(c) is ap- plicable to the
p.001103: individual.
p.001103: (g) BREACH OF AGREEMENT.—
p.001103: (1) IN GENERAL.—In the case of any program under this section under which an individual makes an agreement to
p.001103: pro- vide health services for a period of time in accordance with such program in consideration of receiving
p.001103: an award of Federal funds regarding education as a nurse (including an award for the repayment of loans), the
p.001103: following applies if the agreement provides that this subsection is applicable:
p.001103: (A) In the case of a program under this section that makes an award of Federal funds for attending an accred-
p.001103: ited program of nursing (in this section referred to as a ‘‘nursing program’’), the individual is liable to
p.001103: the Federal Government for the amount of such award (including amounts provided for expenses related
p.001103: to such attend- ance), and for interest on such amount at the maximum legal prevailing rate, if the
p.001103: individual—
p.001103: (i) fails to maintain an acceptable level of aca- demic standing in the nursing program (as indicated by
p.001103: the program in accordance with requirements es- tablished by the Secretary);
p.001103: (ii) is dismissed from the nursing program for dis- ciplinary reasons; or
p.001103: (iii) voluntarily terminates the nursing program.
p.001103: (B) The individual is liable to the Federal Government for the amount of such award (including amounts provided for
p.001103: expenses related to such attendance), and for interest on such amount at the maximum legal prevailing
p.001103: rate, if the individual fails to provide health services in accord- ance with the program under this section
p.001103: for the period of time applicable under the program.
p.001103: (2) WAIVER OR SUSPENSION OF LIABILITY.—In the case of an individual or health facility making an agreement for
p.001103: purposes of paragraph (1), the Secretary shall provide for the waiver or suspension of liability under such
p.001103: subsection if compliance by the individual or the health facility, as the case may be, with the
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p.001105: under subsection
p.001105: (a) shall be made to an individual on such terms and conditions as the school may determine, except that—
p.001105: (1) such terms and conditions are subject to any condi- tions, limitations, and requirements prescribed
p.001105: by the Sec- retary;
p.001105: (2) in the case of any individual, the total of the loans for any academic year made by schools of nursing from loan
p.001105: funds established pursuant to agreements under subsection (a) may not exceed $35,500, during fiscal years
p.001105: 2010 and 2011 fiscal years (after fiscal year 2011, such amounts shall be adjusted to provide for a
p.001105: cost-of-attendance increase for the yearly loan rate and the aggregate loan;
p.001105: (3) an amount up to 85 percent of any such loan (plus in- terest thereon) shall be canceled by the school as follows:
p.001105: (A) upon completion by the individual of each of the first, second, and third year of full-time
p.001105: employment, re- quired by the loan agreement entered into under this sub- section, as a faculty member in an
p.001105: accredited a 11 school of nursing, the school shall cancel 20 percent of the principle of, and the interest on, the
p.001105: amount of such loan unpaid on the first day of such employment; and
p.001105: (B) upon completion by the individual of the fourth year of full-time employment, required by the loan
p.001105: agree- ment entered into under this subsection, as a faculty mem- ber in a school of nursing, the school shall
p.001105: cancel 25 per- cent of the principle of, and the interest on, the amount of such loan unpaid on the first day of such
p.001105: employment;
p.001105: (4) such a loan may be used to pay the cost of tuition, fees, books, laboratory expenses, and other reasonable
p.001105: education ex- penses;
p.001105: (5) such a loan shall be repayable in equal or graduated periodic installments (with the right of the
p.001105: borrower to accel- erate repayment) over the 10-year period that begins 9 months after the individual ceases to
p.001105: pursue a course of study at a school of nursing; and
p.001105: (6) such a loan shall—
p.001105:
p.001105:
p.001105:
p.001105:
p.001105: January 30, 2020
p.001105: 11 So in law. Probably should read ‘‘...as a faculty member in an accredited school of nurs- ing...’’.
p.001105: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001105:
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p.001105: Sec. 847 PUBLIC HEALTH SERVICE ACT 1106
p.001105:
p.001105: (A) beginning on the date that is 3 months after the individual ceases to pursue a course of study at
p.001105: a school of nursing, bear interest on the unpaid balance of the loan at the rate of 3 percent per annum; or
p.001105: (B) subject to subsection (e), if the school of nursing determines that the individual will not
p.001105: complete such course of study or serve as a faculty member as required under the loan agreement under
p.001105: this subsection, bear in- terest on the unpaid balance of the loan at the prevailing market rate.
p.001105: (d) PAYMENT OF PROPORTIONATE SHARE.—Where all or any part of a loan, or interest, is canceled under
p.001105: this section, the Sec- retary shall pay to the school an amount equal to the school’s pro- portionate share of the
p.001105: canceled portion, as determined by the Sec- retary.
p.001105: (e) REVIEW BY SECRETARY.—At the request of the individual in- volved, the Secretary may review any determination by an
p.001105: accred- ited school of nursing under subsection (c)(6)(B).
p.001105: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001105: such sums as may be necessary for each of fiscal years 2010 through 2014.
p.001105: SEC. 847. ø297o¿ ELIGIBLE INDIVIDUAL STUDENT LOAN REPAYMENT.
p.001105: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001105: Administration, may enter into an agreement with eligible individuals for the repayment of education loans, in
p.001105: accordance with this section, to increase the number of qualified nursing faculty.
p.001105: (b) AGREEMENTS.—Each agreement entered into under this subsection shall require that the eligible
p.001105: individual shall serve as a full-time member of the faculty of an accredited school of nursing, for a total
p.001105: period, in the aggregate, of at least 4 years during the 6-year period beginning on the later of—
p.001105: (1) the date on which the individual receives a master’s or doctorate nursing degree from an accredited school of
p.001105: nursing; or
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p.001105: (2) the date on which the individual enters into an agree- ment under this subsection.
p.001105: (c) AGREEMENT PROVISIONS.—Agreements entered into pursu- ant to subsection (b) shall be entered into on such
p.001105: terms and condi- tions as the Secretary may determine, except that—
p.001105: (1) not more than 10 months after the date on which the 6-year period described under subsection (b)
p.001105: begins, but in no case before the individual starts as a full-time member of the faculty of an
p.001105: accredited school of nursing the Secretary shall begin making payments, for and on behalf of that
p.001105: individual, on the outstanding principal of, and interest on, any loan of that individual obtained to pay for
p.001105: such degree;
p.001105: (2) for an individual who has completed a master’s in nurs- ing or equivalent degree in nursing—
p.001105: (A) payments may not exceed $10,000 per calendar year; and
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p.001107: (e) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this sec- tion, the term ‘‘eligible individual’’ means an
p.001107: individual who—
p.001107: (1) is a United States citizen, national, or lawful perma- nent resident;
p.001107: (2) holds an unencumbered license as a registered nurse;
p.001107: and
p.001107: (3) has either already completed a master’s or doctorate
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p.001107: January 30, 2020
p.001107: nursing program at an accredited school of nursing or is cur- rently enrolled on a full-time or part-time
p.001107: basis in such a pro- gram.
p.001107: (f) PRIORITY.—For the purposes of this section and section 846A, funding priority will be awarded to
p.001107: School of Nursing Stu- dent Loans that support doctoral nursing students or Individual Student Loan
p.001107: Repayment that support doctoral nursing students.
p.001107: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001107: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001107: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001107:
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p.001107: Sec. 851 PUBLIC HEALTH SERVICE ACT 1108
p.001107:
p.001107: PART F—NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE
p.001107:
p.001107: SEC. 851. ø297t¿ NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE.
p.001107: (a) ESTABLISHMENT.—The Secretary shall establish an advisory council to be known as the National Advisory
p.001107: Council on Nurse Education and Practice (in this section referred to as the ‘‘Advisory Council’’).
p.001107: (b) COMPOSITION.—
p.001107: (1) IN GENERAL.—The Advisory Council shall be composed
p.001107:
p.001107: of—
p.001107:
p.001107: (A) not less than 21, nor more than 23 individuals, who are not officers or employees of the Federal
p.001107: Govern- ment, appointed by the Secretary without regard to the Federal civil service laws, of which—
p.001107: (i) 2 shall be selected from full-time students en- rolled in schools of nursing;
p.001107: (ii) 2 shall be selected from the general public;
p.001107: (iii) 2 shall be selected from practicing profes- sional nurses; and
p.001107: (iv) 9 shall be selected from among the leading au- thorities in the various fields of nursing, higher, sec-
p.001107: ondary education, and associate degree schools of nursing, and from representatives of advanced edu-
p.001107: cation nursing groups (such as nurse practitioners, nurse midwives, and nurse anesthetists), hospitals, and
p.001107: other institutions and organizations which provide nursing services; and
p.001107: (B) the Secretary (or the delegate of the Secretary (who shall be an ex officio member and shall serve as the
p.001107: Chairperson)).
p.001107: (2) APPOINTMENT.—Not later than 90 days after the date
p.001107: of enactment of this Act 12, the Secretary shall appoint the members of the Advisory Council and each such
p.001107: member shall serve a 4 year term. In making such appointments, the Sec- retary shall ensure a fair balance
p.001107: between the nursing profes- sions, a broad geographic representation of members and a bal- ance between urban and rural
p.001107: members. Members shall be ap- pointed based on their competence, interest, and knowledge of the mission of the
p.001107: profession involved. A majority of the mem- bers shall be nurses.
p.001107: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Council under paragraph (1),
p.001107: the Sec- retary shall ensure the adequate representation of minorities.
p.001107: (c) VACANCIES.—
p.001107: (1) IN GENERAL.—A vacancy on the Advisory Council shall be filled in the manner in which the original appointment was
p.001107: made and shall be subject to any conditions which applied with respect to the original appointment.
p.001107:
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p.001107: January 30, 2020
p.001107: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001107: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 845.
p.001107: That Act is Public Law 105–392, enacted November 13, 1998. (Section 123(5) of that Public Law (112 Stat. 3569) added
p.001107: section 845.)
p.001107: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001109: 1109
p.001109: PUBLIC HEALTH SERVICE ACT
p.001109: Sec. 851
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p.001109: (2) FILLING UNEXPIRED TERM.—An individual chosen to fill a vacancy shall be appointed for the unexpired
p.001109: term of the member replaced.
p.001109: (d) DUTIES.—The Advisory Council shall—
p.001109: (1) provide advice and recommendations to the Secretary and Congress concerning policy matters arising in the
p.001109: adminis- tration of this title, including the range of issues relating to the nurse workforce, education, and
p.001109: practice improvement;
p.001109: (2) provide advice to the Secretary and Congress in the preparation of general regulations and with
p.001109: respect to policy matters arising in the administration of this title, including the range of issues
p.001109: relating to nurse supply, education and practice improvement; and
p.001109: (3) not later than 3 years after the date of enactment of this section, and annually thereafter,
p.001109: prepare and submit to the Secretary, the Committee on Labor and Human Resources of the Senate, and the
p.001109: Committee on Commerce of the House of Representatives, a report describing the activities of the Council,
p.001109: including findings and recommendations made by the Council concerning the activities under this title.
p.001109: (e) MEETINGS AND DOCUMENTS.—
p.001109: (1) MEETINGS.—The Advisory Council shall meet not less than 2 times each year. Such meetings shall be
p.001109: held jointly with other related entities established under this title where appropriate.
p.001109: (2) DOCUMENTS.—Not later than 14 days prior to the con- vening of a meeting under paragraph (1), the Advisory
p.001109: Council shall prepare and make available an agenda of the matters to be considered by the Advisory Council at such
p.001109: meeting. At any such meeting, the Advisory Council shall distribute materials with respect to the issues to be
p.001109: addressed at the meeting. Not later than 30 days after the adjourning of such a meeting, the Advisory Council shall
p.001109: prepare and make available a summary of the meeting and any actions taken by the Council based upon the
p.001109: meeting.
p.001109: (f) COMPENSATION AND EXPENSES.—
p.001109: (1) COMPENSATION.—Each member of the Advisory Council shall be compensated at a rate equal to the daily equivalent of
p.001109: the annual rate of basic pay prescribed for level IV of the Exec- utive Schedule under section 5315 of title 5,
p.001109: United States Code, for each day (including travel time) during which such member is engaged in the
p.001109: performance of the duties of the Council. All members of the Council who are officers or em- ployees of
p.001109: the United States shall serve without compensation in addition to that received for their services as officers or em-
p.001109: ployees of the United States.
p.001109: (2) EXPENSES.—The members of the Advisory Council shall be allowed travel expenses, including per diem in lieu
p.001109: of sub- sistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5,
p.001109: United States Code, while away from their homes or regular places of business in the per- formance of services for the
p.001109: Council.
p.001109: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001109: Sec. 861 PUBLIC HEALTH SERVICE ACT 1110
p.001109:
p.001109: (g) FUNDING.—Amounts appropriated under this title may be utilized by the Secretary to support the nurse
p.001109: education and prac- tice activities of the Council.
p.001109: (h) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section
p.001109: only to the extent that the provisions of such Act do not conflict with the require- ments of this
p.001109: section.
p.001109: PART G—PUBLIC SERVICE ANNOUNCEMENTS
p.001109: SEC. 861. ø297w¿ PUBLIC SERVICE ANNOUNCEMENTS.
p.001109: (a) IN GENERAL.—The Secretary shall develop and issue public service announcements that advertise and promote the
p.001109: nursing profession, highlight the advantages and rewards of nursing, and encourage individuals to enter the
p.001109: nursing profession.
p.001109: (b) METHOD.—The public service announcements described in subsection (a) shall be broadcast through
p.001109: appropriate media out- lets, including television or radio, in a manner intended to reach as wide and
p.001109: diverse an audience as possible.
p.001109: (c) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001109: such sums as may be necessary for each of fiscal years 2003 through 2007.
p.001109: SEC. 862. ø297x¿ STATE AND LOCAL PUBLIC SERVICE ANNOUNCE- MENTS.
p.001109: (a) IN GENERAL.—The Secretary may award grants to eligible entities to support State and local
p.001109: advertising campaigns through appropriate media outlets to promote the nursing profession, high- light the
p.001109: advantages and rewards of nursing, and encourage indi- viduals from disadvantaged backgrounds to enter the
p.001109: nursing pro- fession.
p.001109: (b) USE OF FUNDS.—An eligible entity that receives a grant under subsection (a) shall use funds received
p.001109: through such grant to acquire local television and radio time, place advertisements in local newspapers, or
p.001109: post information on billboards or on the Inter- net in a manner intended to reach as wide and diverse an audience as
p.001109: possible, in order to—
p.001109: (1) advertise and promote the nursing profession;
p.001109: (2) promote nursing education programs;
p.001109: (3) inform the public of financial assistance regarding such education programs;
p.001109: (4) highlight individuals in the community who are prac- ticing nursing in order to recruit new nurses; or
p.001109: (5) provide any other information to recruit individuals for the nursing profession.
p.001109: (c) LIMITATION.—An eligible entity that receives a grant under subsection (a) shall not use funds received
p.001109: through such grant to advertise particular employment opportunities.
p.001109: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001109: sums as may be necessary for each of fiscal years 2003 through 2007.
p.001109:
p.001109: January 30, 2020 As Amended Through P.L. 116-94,
p.001109: Enacted December 20, 2019
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p.001111: PUBLIC HEALTH SERVICE ACT
p.001111: Sec. 871
p.001111:
p.001111: PART H—COMPREHENSIVE GERIATRIC EDUCATION
p.001111: SEC. 865. ø298¿ COMPREHENSIVE GERIATRIC EDUCATION.
p.001111: (a) PROGRAM AUTHORIZED.—The Secretary shall award grants to eligible entities to develop and
p.001111: implement, in coordination with programs under section 753, programs and initiatives to train and educate
p.001111: individuals in providing geriatric care for the elderly.
p.001111: (b) USE OF FUNDS.—An eligible entity that receives a grant under subsection (a) shall use funds under such
p.001111: grant to—
p.001111: (1) provide training to individuals who will provide geri- atric care for the elderly;
p.001111: (2) develop and disseminate curricula relating to the treat- ment of the health problems of elderly individuals;
p.001111: (3) train faculty members in geriatrics;
p.001111: (4) provide continuing education to individuals who pro- vide geriatric care; or
p.001111: (5) establish traineeships for individuals who are pre- paring for advanced education nursing
p.001111: degrees in geriatric nursing, long-term care, gero-psychiatric nursing or other nurs- ing areas that specialize
p.001111: in the care of the elderly population.
p.001111: (c) APPLICATION.—An eligible entity desiring a grant under subsection (a) shall submit an application to the
p.001111: Secretary at such time, in such manner, and containing such information as the Sec- retary may reasonably require.
p.001111: (d) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ includes a school of nursing, a
p.001111: health care facility, a program leading to certification as a certified nurse assistant, a partnership of
p.001111: such a school and facility, or a partnership of such a program and facility.
p.001111: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001111: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001111: PART I—FUNDING
p.001111: SEC. 871. ø298d¿ AUTHORIZATION OF APPROPRIATIONS.
p.001111: For the purpose of carrying out parts B, C, and D (subject to section 851(g)), there are
p.001111: authorized to be appropriated
p.001111: $338,000,000 for fiscal year 2010, and such sums as may be nec- essary for each of the fiscal years 2011
p.001111: through 2016.
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p.001111: Enacted December 20, 2019
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p.001113: the Social Security Act and the So- cial Security Amendments of 1967. Activities under subsection (a)(2) of
p.001113: this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall
p.001113: be carried out con- sistent with section 1142 of such Act.
p.001113: (e) DISCLAIMER.—The Agency shall not mandate national standards of clinical practice or quality health care
p.001113: standards. Rec- ommendations resulting from projects funded and published by the Agency shall include a corresponding
p.001113: disclaimer.
p.001113: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to imply that the Agency’s role is to
p.001113: mandate a national standard or specific approach to quality measurement and report- ing. In research and
p.001113: quality improvement activities, the Agency shall consider a wide range of choices, providers, health care deliv-
p.001113: ery systems, and individual preferences.
p.001113: SEC. 903. ø299a–1¿ RESEARCH ON HEALTH DISPARITIES.
p.001113: (a) IN GENERAL.—The Director shall—
p.001113: (1) conduct and support research to identify populations for which there is a significant disparity in
p.001113: the quality, out- comes, cost, or use of health care services or access to and sat- isfaction with such services,
p.001113: as compared to the general popu- lation;
p.001113: (2) conduct and support research on the causes of and bar- riers to reducing the health disparities identified in
p.001113: paragraph (1), taking into account such factors as socioeconomic status, attitudes toward health, the language
p.001113: spoken, the extent of for- mal education, the area or community in which the population resides, and other factors the
p.001113: Director determines to be appro- priate;
p.001113: (3) conduct and support research and support demonstra- tion projects to identify, test, and evaluate strategies
p.001113: for reduc- ing or eliminating health disparities, including development or identification of effective service delivery
p.001113: models, and dissemi- nate effective strategies and models;
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001115: PUBLIC HEALTH SERVICE ACT
p.001115: Sec. 903
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p.001115: (4) develop measures and tools for the assessment and im- provement of the outcomes, quality, and appropriateness
p.001115: of health care services provided to health disparity populations;
p.001115: (5) in carrying out section 902(c), provide support to in- crease the number of researchers who are
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p.001117: quality, the Agency may provide scientific and technical support for private and public efforts to improve health care
p.001117: quality, including the activities of accrediting organizations.
p.001117: (2) ROLE OF THE AGENCY.—With respect to paragraph (1), the role of the Agency shall include—
p.001117: (A) the identification and assessment of methods for the evaluation of the health of—
p.001117: (i) enrollees in health plans by type of plan, pro- vider, and provider arrangements; and
p.001117: (ii) other populations, including those receiving long-term care services;
p.001117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001117: Sec. 912 PUBLIC HEALTH SERVICE ACT 1118
p.001117: (B) the ongoing development, testing, and dissemina- tion of quality measures, including measures of health and
p.001117: functional outcomes;
p.001117: (C) the compilation and dissemination of health care quality measures developed in the private and public
p.001117: sec- tor;
p.001117: (D) assistance in the development of improved health care information systems;
p.001117: (E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their
p.001117: health care; and
p.001117: (F) identifying and disseminating information on mechanisms for the integration of information on
p.001117: quality into purchaser and consumer decision-making processes.
p.001117: (b) CENTERS FOR EDUCATION AND RESEARCH ON THERA-
p.001117: PEUTICS.—
p.001117: (1) IN GENERAL.—The Secretary, acting through the Direc- tor and in consultation with the Commissioner of Food
p.001117: and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and
p.001117: operation of one or more centers to carry out the activities specified in paragraph (2).
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p.001117: (2) REQUIRED ACTIVITIES.—The activities referred to in this paragraph are the following:
p.001117: (A) The conduct of state-of-the-art research for the fol- lowing purposes:
p.001117: (i) To increase awareness of—
p.001117: (I) new uses of drugs, biological products, and devices;
p.001117: (II) ways to improve the effective use of drugs, biological products, and devices; and
p.001117: (III) risks of new uses and risks of combina- tions of drugs and biological products.
p.001117: (ii) To provide objective clinical information to the following individuals and entities:
p.001117: (I) Health care practitioners and other pro- viders of health care goods or services.
p.001117: (II) Pharmacists, pharmacy benefit managers and purchasers.
p.001117: (III) Health maintenance organizations and other managed health care organizations.
p.001117: (IV) Health care insurers and governmental agencies.
p.001117: (V) Patients and consumers.
p.001117: (iii) To improve the quality of health care while reducing the cost of health care through—
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p.001121: sub- section as the ‘‘Center’’) that shall serve as the principal source of funding for primary care practice
p.001121: research in the Depart- ment of Health and Human Services. For purposes of this paragraph, primary care
p.001121: research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral
p.001121: to specialty care, preventive care, and the relation- ship between the clinician and the patient in the context
p.001121: of the family and community.
p.001121: (2) RESEARCH.—In carrying out this section, the Center shall conduct and support research concerning—
p.001121: (A) the nature and characteristics of primary care practice;
p.001121: (B) the management of commonly occurring clinical problems;
p.001121: (C) the management of undifferentiated clinical prob- lems; and
p.001121: (D) the continuity and coordination of health services.
p.001121: SEC. 916. ø299b–5¿ HEALTH CARE PRACTICE AND TECHNOLOGY INNO- VATION.
p.001121: (a) IN GENERAL.—The Director shall promote innovation in evi- dence-based health care practices and technologies by—
p.001121: (1) conducting and supporting research on the develop- ment, diffusion, and use of health care technology;
p.001121: (2) developing, evaluating, and disseminating methodolo- gies for assessments of health care practices and
p.001121: technologies;
p.001121: (3) conducting intramural and supporting extramural as- sessments of existing and new health care
p.001121: practices and tech- nologies;
p.001121: (4) promoting education and training and providing tech- nical assistance in the use of health care
p.001121: practice and tech- nology assessment methodologies and results; and
p.001121: (5) working with the National Library of Medicine and the public and private sector to develop an electronic
p.001121: clearinghouse of currently available assessments and those in progress.
p.001121: (b) SPECIFICATION OF PROCESS.—
p.001121: (1) IN GENERAL.—Not later than December 31, 2000, the Director shall develop and publish a description of the
p.001121: methods used by the Agency and its contractors for health care practice and technology assessment.
p.001121: (2) CONSULTATIONS.—In carrying out this subsection, the Director shall cooperate and consult with the
p.001121: Assistant Sec-
p.001121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001123: PUBLIC HEALTH SERVICE ACT
p.001123: Sec. 916
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p.001123: (A) safety, efficacy, and effectiveness;
p.001123: (B) legal, social, and ethical implications;
p.001123: (C) costs, benefits, and cost-effectiveness;
p.001123: (D) comparisons to alternate health care practices and technologies; and
p.001123: (E) requirements of Food and Drug Administration ap- proval to avoid duplication.
p.001123: (c) SPECIFIC ASSESSMENTS.—
p.001123: (1) IN GENERAL.—The Director shall conduct or support specific assessments of health care technologies and
p.001123: practices.
p.001123: (2) REQUESTS FOR ASSESSMENTS.—The Director is author- ized to conduct or support assessments, on a
p.001123: reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the
p.001123: Department of Veterans Affairs, the Office of Personnel Management, and other public or pri- vate entities.
p.001123: (3) GRANTS AND CONTRACTS.—In addition to conducting as- sessments, the Director may make grants to, or enter
p.001123: into co- operative agreements or contracts with, entities described in paragraph (4) for the purpose of
p.001123: conducting assessments of ex- perimental, emerging, existing, or potentially outmoded health care technologies, and for
p.001123: related activities.
p.001123: (4) ELIGIBLE ENTITIES.—An entity described in this para- graph is an entity that is determined to be appropriate
p.001123: by the Director, including academic medical centers, research institu- tions and organizations, professional
p.001123: organizations, third party payers, governmental agencies, minority institutions of higher education (such as
p.001123: Historically Black Colleges and Univer- sities, and Hispanic institutions), and consortia of appropriate
p.001123: research entities established for the purpose of conducting technology assessments.
p.001123: (d) MEDICAL EXAMINATION OF CERTAIN VICTIMS.—
p.001123: (1) IN GENERAL.—The Director shall develop and dissemi- nate a report on evidence-based clinical practices for—
p.001123: (A) the examination and treatment by health profes- sionals of individuals who are victims of sexual assault
p.001123: (in- cluding child molestation) or attempted sexual assault; and
p.001123: (B) the training of health professionals, in consultation with the Health Resources and Services Administration,
p.001123: on performing medical evidentiary examinations of individ- uals who are victims of child abuse or neglect,
p.001123: sexual as- sault, elder abuse, or domestic violence.
p.001123: (2) CERTAIN CONSIDERATIONS.—In identifying the issues to be addressed by the report, the Director shall,
p.001123: to the extent practicable, take into consideration the expertise and experi- ence of Federal and State
p.001123: law enforcement officials regarding
p.001123: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001125: PUBLIC HEALTH SERVICE ACT
p.001125: Sec. 921
p.001125:
p.001125: (i) the improved coordination of activities across the medicare, medicaid and child health insurance
p.001125: programs under titles XVIII, XIX and XXI of the So- cial Security Act and health services research pro-
p.001125: grams;
p.001125: (ii) the strengthening of patient choice and partici- pation by incorporating state-of-the-art quality moni-
p.001125: toring tools and making information on quality avail- able; and
p.001125: (iii) the enhancement of the most effective pro- grams, consolidation as appropriate, and elimination of
p.001125: duplicative activities within various Federal agen- cies.
p.001125: (2) REQUIREMENTS.—
p.001125: (A) IN GENERAL.—The Secretary shall enter into a con- tract with the Institute of Medicine for the preparation—
p.001125: (i) not later than 12 months after the date of the enactment of this title, of a report providing an
p.001125: over- view of the quality improvement programs of the De- partment of Health and Human Services for the medi-
p.001125: care, medicaid, and CHIP programs under titles XVIII,
p.001125: XIX, and XXI of the Social Security Act; and
p.001125: (ii) not later than 24 months after the date of the enactment of this title, of a final report containing rec-
p.001125: ommendations.
p.001125: (B) REPORTS.—The Secretary shall submit the reports described in subparagraph (A) to the Committee on Fi-
p.001125: nance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on
p.001125: Ways and Means and the Committee on Commerce of the House of Representatives.
p.001125: PART C—PATIENT SAFETY IMPROVEMENT
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p.001125: SEC. 921. ø299b–21¿ DEFINITIONS.
p.001125: In this part:
p.001125: (1) HIPAA CONFIDENTIALITY REGULATIONS.—The term ‘‘HIPAA confidentiality regulations’’ means regulations
p.001125: promul- gated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law
p.001125: 104–191; 110 Stat. 2033).
p.001125: (2) IDENTIFIABLE PATIENT SAFETY WORK PRODUCT.—The term ‘‘identifiable patient safety work product’’
p.001125: means patient safety work product that—
p.001125: (A) is presented in a form and manner that allows the identification of any provider that is a subject of the work
p.001125: product, or any providers that participate in activities that are a subject of the work product;
p.001125: (B) constitutes individually identifiable health infor- mation as that term is defined in the HIPAA
p.001125: confiden- tiality regulations; or
p.001125: (C) is presented in a form and manner that allows the identification of an individual who reported information in the
p.001125: manner specified in section 922(e).
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p.001139: ture and system design of a health care organization, that con- tribute to the success and sustainability of specific
p.001139: quality im- provement and patient safety strategies;
p.001139: (8) provide for the development of best practices in the de- livery of health care services that—
p.001139: (A) have a high likelihood of success, based on struc- tured review of empirical evidence;
p.001139: (B) are specified with sufficient detail of the individual processes, steps, training, skills, and knowledge
p.001139: required for implementation and incorporation into workflow of health care practitioners in a variety of
p.001139: settings;
p.001139: (C) are designed to be readily adapted by health care providers in a variety of settings; and
p.001139: (D) where applicable, assist health care providers in working with other health care providers across the
p.001139: con- tinuum of care and in engaging patients and their families in improving the care and patient health outcomes;
p.001139: (9) provide for the funding of the activities of organizations with recognized expertise and excellence in
p.001139: improving the de- livery of health care services, including children’s health care, by involving multiple
p.001139: disciplines, managers of health care enti- ties, broad development and training, patients, caregivers and
p.001139: families, and frontline health care workers, including activities for the examination of strategies to share best
p.001139: quality improve- ment practices and to promote excellence in the delivery of health care services; and
p.001139: (10) build capacity at the State and community level to lead quality and safety efforts through education,
p.001139: training, and mentoring programs to carry out the activities under para- graphs (1) through (9).
p.001139: (c) RESEARCH FUNCTIONS OF CENTER.—
p.001139: (1) IN GENERAL.—The Center shall support, such as through a contract or other mechanism, research
p.001139: on health care delivery system improvement and the development of tools to facilitate adoption of best
p.001139: practices that improve the quality, safety, and efficiency of health care delivery services. Such support
p.001139: may include establishing a Quality Improvement Network Research Program for the purpose of testing, scaling, and
p.001139: disseminating of interventions to improve quality and effi- ciency in health care. Recipients of funding under the
p.001139: Program may include national, State, multi-State, or multi-site quality improvement networks.
p.001139: (2) RESEARCH REQUIREMENTS.—The research conducted pursuant to paragraph (1) shall—
p.001139: (A) address the priorities identified by the Secretary in the national strategic plan established under
p.001139: section 399HH;
p.001139: (B) identify areas in which evidence is insufficient to identify strategies and methodologies, taking into
p.001139: consider- ation areas of insufficient evidence identified by the entity with a contract under section 1890(a) of the
p.001139: Social Security Act in the report required under section 399JJ;
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p.001141: PUBLIC HEALTH SERVICE ACT
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p.001145: (c) MTM SERVICES TO TARGETED INDIVIDUALS.—The MTM services provided with the assistance of a grant or
p.001145: contract award- ed under subsection (a) shall, as allowed by State law including ap- plicable collaborative pharmacy
p.001145: practice agreements, include—
p.001145: (1) performing or obtaining necessary assessments of the health and functional status of each patient
p.001145: receiving such MTM services;
p.001145: (2) formulating a medication treatment plan according to therapeutic goals agreed upon by the prescriber
p.001145: and the pa- tient or caregiver or authorized representative of the patient;
p.001145: (3) selecting, initiating, modifying, recommending changes to, or administering medication therapy;
p.001145: (4) monitoring, which may include access to, ordering, or performing laboratory assessments, and
p.001145: evaluating the re- sponse of the patient to therapy, including safety and effective- ness;
p.001145: (5) performing an initial comprehensive medication review to identify, resolve, and prevent medication-related
p.001145: problems, including adverse drug events, quarterly targeted medication reviews for ongoing monitoring, and
p.001145: additional followup inter- ventions on a schedule developed collaboratively with the pre- scriber;
p.001145: (6) documenting the care delivered and communicating es- sential information about such care, including a
p.001145: summary of the medication review, and the recommendations of the phar- macist to other appropriate health care
p.001145: providers of the patient in a timely fashion;
p.001145: (7) providing education and training designed to enhance the understanding and appropriate use of the
p.001145: medications by the patient, caregiver, and other authorized representative;
p.001145: (8) providing information, support services, and resources and strategies designed to enhance patient
p.001145: adherence with therapeutic regimens;
p.001145: (9) coordinating and integrating MTM services within the broader health care management services provided
p.001145: to the pa- tient; and
p.001145: (10) such other patient care services allowed under phar- macist scopes of practice in use in other Federal
p.001145: programs that have implemented MTM services.
p.001145: (d) TARGETED INDIVIDUALS.—MTM services provided by li- censed pharmacists under a grant or contract
p.001145: awarded under sub- section (a) shall be offered to targeted individuals who—
p.001145: (1) take 4 or more prescribed medications (including over- the-counter medications and dietary supplements);
p.001145: (2) take any ‘‘high risk’’ medications;
p.001145: (3) have 2 or more chronic diseases, as identified by the Secretary; or
p.001145: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001163: Secretary may require including assurances for an evaluation whether performed by the applicant or by the
p.001163: Sec- retary. Such grant or contract may be made available on less than a state-wide or regional basis. Each applicant
p.001163: shall—
p.001163: (1) provide that the programs and activities for which as- sistance under this part is sought will be
p.001163: administered by or under the supervision of the applicant;
p.001163: (2) provide for strict confidentiality of all test results, med- ical records, and other information regarding
p.001163: testing, diag- nosis, counseling, or treatment of any person treated, except for (A) such information as the
p.001163: patient (or his guardian) gives informed consent to be released, or (B) statistical data com- piled without
p.001163: reference to the identity of any such patient;
p.001163: (3) provide for community representation where appro- priate in the development and operation of voluntary
p.001163: genetic testing or counseling programs funded by a grant or contract under this part; and
p.001163: (4) establish fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and
p.001163: ac- counting of Federal funds paid to the applicant under this part.
p.001163: (b) In making grants and entering into contracts for any fiscal year under section 301 for projects described in
p.001163: section 1102 the Secretary shall give special consideration to applications from enti- ties that received grants
p.001163: from, or entered into contracts with, the Secretary for the preceding fiscal year for the conduct of
p.001163: com- prehensive sickle cell centers or sickle cell screening and education clinics.
p.001163: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001163: January 30, 2020
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p.001163: PUBLIC HEALTH SERVICE FACILITIES
p.001163: SEC. 1105. ø300b–4¿ The Secretary shall establish a program within the Service to provide voluntary
p.001163: testing, diagnosis, coun- seling, and treatment of individuals respecting genetic diseases. Services under
p.001163: such program shall be made available through fa- cilities of the Service to persons requesting such
p.001163: services, and the program shall provide appropriate publicity of the availability and voluntary nature of such
p.001163: services.
p.001163: SEC. 1106. ø300b–5¿ SICKLE CELL DISEASE AND OTHER HERITABLE BLOOD DISORDERS RESEARCH, SURVEILLANCE, PREVEN-
p.001163: TION, AND TREATMENT.
p.001163: (a) GRANTS.—
p.001163: (1) IN GENERAL.—The Secretary may award grants related to heritable blood disorders, including sickle cell
p.001163: disease, for one or more of the following purposes:
p.001163: (A) To collect and maintain data on such diseases and conditions, including subtypes as applicable, and their
p.001163: as- sociated health outcomes and complications, including for the purpose of—
p.001163: (i) improving national incidence and prevalence data;
p.001163: (ii) identifying health disparities, including the ge- ographic distribution, related to such diseases and
p.001163: conditions;
p.001163: (iii) assessing the utilization of therapies and strategies to prevent complications; and
p.001163: (iv) evaluating the effects of genetic, environ- mental, behavioral, and other risk factors that may af-
p.001163: fect such individuals.
p.001163: (B) To conduct public health activities with respect to such conditions, which may include—
p.001163: (i) developing strategies to improve health out- comes and access to quality health care for the screen- ing
p.001163: for, and treatment and management of, such dis- eases and conditions, including through public-private
p.001163: partnerships;
p.001163: (ii) providing support to community-based organi- zations and State and local health departments in con- ducting
p.001163: education and training activities for patients, communities, and health care providers concerning such
p.001163: diseases and conditions;
p.001163: (iii) supporting State health departments and re- gional laboratories, including through training, in test- ing
p.001163: to identify such diseases and conditions, including specific forms of sickle cell disease, in individuals of all ages;
p.001163: and
p.001163: (iv) the identification and evaluation of best prac- tices for treatment of such diseases and conditions, and
p.001163: prevention and management of their related com- plications.
p.001163: (2) POPULATION INCLUDED.—The Secretary shall, to the ex- tent practicable, award grants under this subsection to
p.001163: eligible entities across the United States to improve data on the inci-
p.001163: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001165: 1165
p.001165: PUBLIC HEALTH SERVICE ACT
p.001165: Sec. 1106
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p.001165: dence and prevalence of heritable blood disorders, including sickle cell disease, and the geographic
p.001165: distribution of such dis- eases and conditions.
p.001165: (3) APPLICATION.—To seek a grant under this subsection, an eligible entity shall submit an application to
p.001165: the Secretary at such time, in such manner, and containing such information as the Secretary may require.
p.001165: (4) PRIORITY.—In awarding grants under this subsection, the Secretary may give priority, as appropriate, to
p.001165: eligible enti- ties that have a relationship with a community-based organiza- tion that has experience in, or is
p.001165: capable of, providing services to individuals with heritable blood disorders, including sickle cell disease.
p.001165: (5) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ includes the 50 States, the District of
p.001165: Columbia, the Commonwealth of Puerto Rico, the United States Virgin Is- lands, the Commonwealth of the
p.001165: Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of Marshall
p.001165: Islands, the Republic of Palau, Indian tribes, a State or local health department, an institution of higher
p.001165: education, or a nonprofit entity with appropriate experi- ence to conduct the activities under this subsection.
p.001165: (b) DEMONSTRATION PROGRAM FOR THE DEVELOPMENT AND ES-
p.001165: TABLISHMENT OF SYSTEMIC MECHANISMS FOR THE PREVENTION AND
p.001165: TREATMENT OF SICKLE CELL DISEASE.—
p.001165: (1) AUTHORITY TO CONDUCT DEMONSTRATION PROGRAM.—
p.001165: (A) IN GENERAL.—The Administrator, through the Bu- reau of Primary Health Care and the Maternal and Child Health
p.001165: Bureau, shall continue efforts, including by award- ing grants, to develop or establish mechanisms to improve the
p.001165: treatment of sickle cell disease, and to improve the prevention and treatment of complications of sickle
p.001165: cell disease, in populations with a high proportion of individ- uals with sickle cell disease, including
p.001165: through—
p.001165: (i) the coordination of service delivery for individ- uals with sickle cell disease;
p.001165: (ii) genetic counseling and testing;
p.001165: (iii) bundling of technical services related to the prevention and treatment of sickle cell disease;
p.001165: (iv) training of health professionals; and
p.001165: (v) identifying and establishing other efforts re- lated to the expansion and coordination of education,
p.001165: treatment, and continuity of care programs for individ- uals with sickle cell disease.
p.001165: (B) GEOGRAPHIC DIVERSITY.—The Administrator shall, to the extent practicable, award grants under this
p.001165: section to eligible entities located in different regions of the United States.
p.001165: (2) ADDITIONAL REQUIREMENTS.—An eligible entity award- ed a grant under this subsection shall use
p.001165: funds made avail- able under the grant to carry out, in addition to the activities described in paragraph
p.001165: (1)(A), the following activities:
p.001165: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001165: individuals with sickle cell disease under—
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p.001167: organizations; and
p.001167: (3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and
p.001167: in minor- ity groups.
p.001167: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001167: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
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p.001171: (F) minimum standards and related policies and proce- dures used by State newborn screening programs, such as language
p.001171: and terminology used by State newborn screen- ing programs to include standardization of case definitions and
p.001171: names of disorders for which newborn screening tests are performed;
p.001171: (G) quality assurance, oversight, and evaluation of State newborn screening programs, including
p.001171: ensuring that tests and technologies used by each State meet estab- lished standards for detecting and
p.001171: reporting positive screening results;
p.001171: (H) public and provider awareness and education;
p.001171: (I) the cost and effectiveness of newborn screening and medical evaluation systems and intervention programs
p.001171: conducted by State-based programs;
p.001171: (J) identification of the causes of, public health im- pacts of, and risk factors for heritable disorders;
p.001171: (K) coordination of surveillance activities, including standardized data collection and reporting,
p.001171: harmonization of laboratory definitions for heritable disorders and testing results, and confirmatory testing and
p.001171: verification of posi- tive results, in order to assess and enhance monitoring of newborn diseases; and
p.001171: (L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable
p.001171: disorders in newborns in order to ensure rapid diagnosis and fol- lowup.
p.001171: (c) MEMBERSHIP.—
p.001171: (1) IN GENERAL.—The Secretary shall appoint not to exceed
p.001171: 15 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001171: total member- ship of the Advisory Committee is an odd number.
p.001171: (2) REQUIRED MEMBERS.—The Secretary shall appoint to the Advisory Committee under paragraph (1)—
p.001171: (A) the Administrator of the Health Resources and Services Administration;
p.001171: (B) the Director of the Centers for Disease Control and Prevention;
p.001171: (C) the Director of the National Institutes of Health;
p.001171: (D) the Director of the Agency for Healthcare Research and Quality;
p.001171: (E) the Commissioner of the Food and Drug Adminis- tration;
p.001171: (F) medical, technical, or scientific professionals with special expertise in heritable disorders, or in
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p.001175: in Newborns and Children established under section 1111, may provide, as appropriate, for the
p.001175: coordina- tion of surveillance activities, including—
p.001175: (1) through standardized data collection and reporting, as well as the use of electronic health records; and
p.001175: (2) by promoting data sharing regarding newborn screen- ing with State-based birth defects and
p.001175: developmental disabil- ities monitoring programs.
p.001175: SEC. 1114. ø300b–13¿ INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND CHILD SCREENING.
p.001175: (a) PURPOSE.—It is the purpose of this section to—
p.001175: (1) assess existing activities and infrastructure, including activities on birth defects and developmental
p.001175: disabilities au- thorized under section 317C, in order to make recommenda- tions for programs to collect,
p.001175: analyze, and make available data on the heritable disorders recommended by the Advisory Com- mittee on Heritable
p.001175: Disorders in Newborns and Children under section 1111, including data on the incidence and prevalence of, as
p.001175: well as poor health outcomes resulting from, such dis- orders; and
p.001175: (2) make recommendations for the establishment of re- gional centers for the conduct of applied
p.001175: epidemiological re- search on effective interventions to promote the prevention of poor health outcomes
p.001175: resulting from such disorders as well as providing information and education to the public on such ef-
p.001175: fective interventions.
p.001175: (b) ESTABLISHMENT.—The Secretary shall establish an Inter- agency Coordinating Committee on Newborn and
p.001175: Child Screening (referred to in this section as the ‘‘Interagency Coordinating Com- mittee’’) to carry out
p.001175: the purpose of this section.
p.001175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001175: Sec. 1115 PUBLIC HEALTH SERVICE ACT 1176
p.001175: (c) COMPOSITION.—The Interagency Coordinating Committee shall be composed of the Director of the Centers
p.001175: for Disease Con- trol and Prevention, the Administrator of the Health Resources and Services Administration, the
p.001175: Director of the Agency for Healthcare Research and Quality, the Commissioner of Food and Drugs, and the
p.001175: Director of the National Institutes of Health, or their designees.
p.001175: (d) ACTIVITIES.—The Interagency Coordinating Committee shall—
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p.001179: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001179: of carrying out re- search and demonstration projects with respect to improving the availability and
p.001179: quality of emergency medical services in rural areas—
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p.001179: January 30, 2020
p.001179: (1) by developing innovative uses of communications tech- nologies and the use of new communications technology;
p.001179: (2) by developing model curricula, such as advanced trau- ma life support, for training emergency medical
p.001179: services per- sonnel, including first responders, emergency medical techni- cians, emergency nurses and
p.001179: physicians, and paramedics—
p.001179: (A) in the assessment, stabilization, treatment, prepa- ration for transport, and resuscitation of seriously
p.001179: injured patients, with special attention to problems that arise dur- ing long transports and to methods of
p.001179: minimizing delays in transport to the appropriate facility; and
p.001179: (B) in the management of the operation of the emer- gency medical services system;
p.001179: (3) by making training for original certification, and con- tinuing education, in the provision and
p.001179: management of emer- gency medical services more accessible to emergency medical personnel in rural areas
p.001179: through telecommunications, home studies, providing teachers and training at locations accessible to such personnel,
p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
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p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001185: Sec. 1213 PUBLIC HEALTH SERVICE ACT 1186
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p.001185: (9) provides for appropriate transportation and transfer policies to ensure the delivery of patients to
p.001185: designated trauma centers and other facilities within and outside of the jurisdic- tion of such system,
p.001185: including policies to ensure that only indi- viduals appropriately identified as trauma patients are trans-
p.001185: ferred to designated trauma centers, and to provide periodic re- views of the transfers and the auditing of
p.001185: such transfers that are determined to be appropriate;
p.001185: (10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
p.001185: (11) coordinates planning for trauma systems with State disaster emergency planning and bioterrorism
p.001185: hospital pre- paredness planning; and
p.001185: (12) with respect to the requirements established in this subsection, provides for coordination and
p.001185: cooperation between the State and any other State with which the State shares any standard metropolitan statistical
p.001185: area.
p.001185: (b) CERTAIN STANDARDS WITH RESPECT TO TRAUMA CARE CEN-
p.001185: TERS AND SYSTEMS.—
p.001185: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) for a fiscal year unless the
p.001185: State in- volved agrees that, in carrying out paragraphs (3) through (5) of subsection (a), the State
p.001185: will adopt standards for the des- ignation of trauma centers, and for triage, transfer, and trans- portation
p.001185: policies, and that the State will, in adopting such standards—
p.001185: (A) take into account national standards that outline resources for optimal care of injured patients;
p.001185: (B) consult with medical, surgical, and nursing spe- ciality groups, hospital associations, emergency
p.001185: medical services State and local directors, concerned advocates, and other interested parties;
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p.001191: out part A—
p.001191: (1) 10 percent of such amounts for such year shall be allo- cated for administrative purposes; and
p.001191: (2) 10 percent of such amounts for such year shall be allo- cated for the purpose of carrying out section 1202.
p.001191: (d) AUTHORITY.—For the purpose of carrying out parts A through C, beginning on the date of enactment of
p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
p.001191: (3) to provide emergency relief to ensure the continued and future availability of trauma services.
p.001191: (b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS.—
p.001191: (1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—Except as
p.001191: pro- vided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a)
p.001191: unless the trauma cen- ter is a participant in a trauma system that substantially com- plies with section 1213.
p.001191: (2) EXEMPTION.—Paragraph (1) shall not apply to trauma centers that are located in States with no existing
p.001191: trauma care system.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001193: PUBLIC HEALTH SERVICE ACT
p.001193: Sec. 1242
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p.001193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001193: Sec. 1243 PUBLIC HEALTH SERVICE ACT 1194
p.001193: 1241(a)(1) according to the percentage described in paragraph (2), subject to the requirements of section
p.001193: 1241(b)(3).
p.001193: (2) PERCENTAGES.—The applicable percentages are as fol- lows:
p.001193: (A) With respect to a category A trauma center, 100 percent of the uncompensated care costs.
p.001193: (B) With respect to a category B trauma center, not more than 75 percent of the uncompensated care costs.
p.001193: (C) With respect to a category C trauma center, not more than 50 percent of the uncompensated care costs.
p.001193: (b) 1 CORE MISSION AWARDS.—
p.001193: (1) IN GENERAL.—In awarding grants under section 1241(a)(2), the Secretary shall—
p.001193: (A) reserve 25 percent of the amount allocated for core mission awards for Level III and Level IV trauma centers; and
p.001193: (B) reserve 25 percent of the amount allocated for core mission awards for large urban Level I and II trauma cen- ters—
p.001193: (i) that have at least 1 graduate medical education fellowship in trauma or trauma related specialties for which
p.001193: demand is exceeding supply;
p.001193: (ii) for which—
p.001193: (I) annual uncompensated care costs exceed
p.001193: $10,000,000; or
p.001193: (II) at least 20 percent of emergency depart- ment visits are charity or self-pay or Medicaid pa- tients; and
p.001193: (iii) that are not eligible for substantial uncompen- sated care awards under section 1241(a)(1).
p.001193: (c) EMERGENCY AWARDS.—In awarding grants under section 1241(a)(3), the Secretary shall—
p.001193: (1) give preference to any application submitted by a trau- ma center that provides trauma care in a geographic
p.001193: area in which the availability of trauma care has significantly de- creased or will significantly
p.001193: decrease if the center is forced to close or downgrade service or growth in demand for trauma services
p.001193: exceeds capacity; and
p.001193: (2) reallocate any emergency awards funds not obligated due to insufficient, or a lack of qualified,
p.001193: applications to the significant uncompensated care award program.
p.001193: SEC. 1243. ø300d–43¿ CERTAIN AGREEMENTS.
p.001193: (a) MAINTENANCE OF FINANCIAL SUPPORT.—The Secretary may require a trauma center receiving a grant under section
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p.001195:
p.001195: other authorization of appropriations or amounts that are available for such purpose.
p.001195: SEC. 1246. ø300d–46¿ DEFINITION.
p.001195: In this part, the term ‘‘uncompensated care costs’’ means unre- imbursed costs from serving self-pay, charity, or
p.001195: Medicaid patients, without regard to payment under section 1923 of the Social Secu- rity Act, all of which
p.001195: are attributable to emergency care and trau- ma care, including costs related to subsequent inpatient admissions to the
p.001195: hospital.
p.001195: Part E—Miscellaneous Programs
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p.001195: SEC. 1251. ø300d–51¿ RESIDENCY TRAINING PROGRAMS IN EMER- GENCY MEDICINE.
p.001195: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001195: of planning and de- veloping approved residency training programs in emergency medi- cine.
p.001195: (b) IDENTIFICATION AND REFERRAL OF DOMESTIC VIOLENCE.— The Secretary may make a grant under subsection
p.001195: (a) only if the applicant involved agrees that the training programs under sub- section (a) will provide
p.001195: education and training in identifying and referring cases of domestic violence.
p.001195: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001195: to be appropriated
p.001195: $400,000 for each of the fiscal years 2008 though 2012.
p.001195: SEC. 1252. ø300d–52¿ STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC BRAIN INJURY.
p.001195: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001195: Living, may make grants to States and American Indian consortia for the purpose of carrying out projects
p.001195: to improve access to rehabilitation and other services regarding traumatic brain injury.
p.001195: (b) STATE ADVISORY BOARD.—
p.001195: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the State or American Indian
p.001195: consortium involved agrees to establish an advisory board within the ap- propriate health department of
p.001195: the State or American Indian consortium or within another department as designated by the chief executive officer
p.001195: of the State or American Indian consor- tium.
p.001195: (2) FUNCTIONS.—An advisory board established under paragraph (1) shall advise and make recommendations
p.001195: to the State or American Indian consortium on ways to improve serv- ices coordination regarding traumatic brain
p.001195: injury. Such advi- sory boards shall encourage citizen participation through the establishment of public
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p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
p.001197: (D) develop best practices in areas such as family or consumer support, return to work, housing or
p.001197: supportive living personal assistance services, assistive technology and devices, behavioral health
p.001197: services, substance abuse services, and traumatic brain injury treatment and reha- bilitation;
p.001197: (E) tailor existing State or American Indian consor- tium systems to provide accommodations to the needs
p.001197: of individuals with traumatic brain injury (including systems administered by the State or American Indian
p.001197: consortium departments responsible for health, mental health, labor/ employment, education, intellectual
p.001197: disabilities or develop- mental disorders, transportation, and correctional sys- tems);
p.001197: (F) improve data sets coordinated across systems and other needs identified by a State or American
p.001197: Indian con- sortium plan supported by its advisory council; and
p.001197: (G) develop capacity within targeted communities.
p.001197: (f) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.001197: coordinated as appropriate
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001199: PUBLIC HEALTH SERVICE ACT
p.001199: Sec. 1253
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p.001199: with other Federal agencies that carry out activities regarding traumatic brain injury.
p.001199: (g) REPORT.—Not less than biennially, the Secretary shall sub- mit to the Committee on Energy and Commerce of
p.001199: the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions of the
p.001199: Senate, a report describing the findings and results of the programs established under this section and sec- tion
p.001199: 1253, including measures of outcomes and consumer and sur- rogate satisfaction.
p.001199: (h) DEFINITIONS.—For purposes of this section:
p.001199: (1) The terms ‘‘American Indian consortium’’ and ‘‘State’’ have the meanings given to those terms in section
p.001199: 1253.
p.001199: (2) The term ‘‘traumatic brain injury’’ means an acquired injury to the brain. Such term does not include brain
p.001199: dysfunc- tion caused by congenital or degenerative disorders, nor birth trauma, but may include brain
p.001199: injuries caused by anoxia due to trauma. The Secretary may revise the definition of such term as the
p.001199: Secretary determines necessary, after consultation with States and other appropriate public or nonprofit
p.001199: private entities.
p.001199: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001199: to be appropriated
p.001199: $7,321,000 for each of fiscal years 2020 through 2024.
p.001199: SEC. 1253. ø300d–53¿ STATE GRANTS FOR PROTECTION AND ADVOCACY SERVICES.
p.001199: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001199: Living, shall make grants to protection and advocacy systems for the purpose of ena- bling such systems
p.001199: to provide services to individuals with trau- matic brain injury.
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p.001205: national media firms, for the devel- opment and implementation of a nationwide poisoning and toxic ex- posure
p.001205: prevention and poison control center awareness campaign, which may include—
p.001205: (1) the development and distribution of poisoning and toxic exposure prevention awareness materials, applicable
p.001205: public health emergency preparedness and response information, and poison control center awareness materials;
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001207: PUBLIC HEALTH SERVICE ACT
p.001207: Sec. 1273
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p.001207: (2) television, radio, Internet, and newspaper public serv- ice announcements; and
p.001207: (3) other activities to provide for public and professional awareness and education.
p.001207: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001207: $800,000 for each of fiscal years 2020 through 2024.
p.001207: SEC. 1273. ø300d–73¿ MAINTENANCE OF THE POISON CONTROL CEN- TER GRANT PROGRAM.
p.001207: (a) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to poison control centers accredited under
p.001207: subsection (c) (or granted a waiver under subsection (d)) and professional organiza- tions in the field of
p.001207: poison control for the purposes of preventing, and providing treatment recommendations for, poisonings and toxic
p.001207: exposures and complying with the operational requirements needed to sustain the accreditation of the center under
p.001207: subsection (c).
p.001207: (b) ADDITIONAL USES OF FUNDS.—In addition to the purposes described in subsection (a), a poison center
p.001207: or professional organi- zation awarded a grant, contract, or cooperative agreement under such subsection
p.001207: may also use amounts received under such grant, contract, or cooperative agreement—
p.001207: (1) to research, establish, implement, and evaluate best practices in the United States for poisoning and toxic
p.001207: exposure prevention, poison control center outreach, and emergency pre- paredness and response programs;
p.001207: (2) to research, develop, implement, revise, and commu- nicate standard patient management guidelines for
p.001207: commonly encountered toxic exposures;
p.001207: (3) to improve national toxic exposure surveillance by en- hancing cooperative activities between poison
p.001207: control centers in the United States, the Centers for Disease Control and Preven- tion, and other government
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p.001207: (f) MAINTENANCE OF EFFORT.—With respect to activities for which a grant is awarded under this section, the
p.001207: Secretary may re- quire that poison control centers agree to maintain the expendi- tures of the center for
p.001207: such activities at a level that is not less than the level of expenditures maintained by the center for the
p.001207: fiscal year preceding the fiscal year for which the grant is received.
p.001207: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001207: $28,600,000 for each of fiscal years 2020 through 2024. The Secretary may utilize an amount not to exceed 6
p.001207: percent of the amount appropriated under this preceding sentence in each fiscal year for coordination, dis-
p.001207: semination, technical assistance, program evaluation, data activi- ties, and other program administration
p.001207: functions, which are deter-
p.001207: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001207:
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p.001209: 1209
p.001209: PUBLIC HEALTH SERVICE ACT
p.001209: Sec. 1281
p.001209:
p.001209: mined by the Secretary to be appropriate for carrying out the pro- gram under this section.
p.001209: (h) BIENNIAL REPORT TO CONGRESS.—Not later than 2 years after the date of enactment of this
p.001209: subsection, and every 2 years thereafter, the Secretary shall submit to the Committee on Health, Education, Labor,
p.001209: and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives a
p.001209: report concerning the operations of, and trends identified by, the Poison Control Network. Such report shall
p.001209: include—
p.001209: (1) descriptions of the activities carried out pursuant to sections 1271, 1272, and 1273, and the
p.001209: alignment of such ac- tivities with the purposes provided under subsection (a);
p.001209: (2) a description of trends in volume of contacts to poison control centers;
p.001209: (3) a description of trends in poisonings and toxic expo- sures reported to poison control centers, as
p.001209: applicable and ap- propriate;
p.001209: (4) an assessment of the impact of the public awareness campaign, including any geographic variations;
p.001209: (5) a description of barriers, if any, preventing poison con- trol centers from achieving the purposes and
p.001209: programs under this section and sections 1271 and 1272;
p.001209: (6) a description of the standards for accreditation de- scribed in subsection (c), including any
p.001209: variations in those standards, and any efforts to create and maintain consistent standards across
p.001209: organizations that accredit poison control cen- ters; and
p.001209: (7) the number of and reason for any waivers provided under subsection (d).
p.001209: SEC. 1274. ø300d–74¿ RULE OF CONSTRUCTION.
p.001209: Nothing in this part may be construed to ease any restriction in Federal law applicable to the amount or
p.001209: percentage of funds ap- propriated to carry out this part that may be used to prepare or submit a report.
p.001209: PART H—TRAUMA SERVICE AVAILABILITY
p.001209:
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p.001211: (c) GRANT REQUIREMENTS.—
p.001211: (1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As a condition of receipt of a grant under this section, a
p.001211: grant re- cipient shall agree to allow military trauma care providers pro- viding care pursuant to such grant to—
p.001211: (A) be deployed by the Secretary of Defense for mili- tary operations, for training, or for response to a mass
p.001211: cas- ualty incident; and
p.001211: (B) be deployed by the Secretary of Defense, in con- sultation with the Secretary of Health and Human
p.001211: Serv- ices, for response to a public health emergency pursuant to section 319.
p.001211: (2) USE OF FUNDS.—Grants awarded under this section to an eligible trauma center may be used to train and
p.001211: incorporate military trauma care providers into such trauma center, in- cluding incorporation into
p.001211: operational exercises and training drills related to public health emergencies, expenditures for malpractice
p.001211: insurance, office space, information technology, specialty education and supervision, trauma
p.001211: programs, re- search, and applicable license fees for such military trauma care providers.
p.001211: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect any other provision of
p.001211: law that preempts State licensing requirements for health care professionals, including with respect to military
p.001211: trauma care providers.
p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
p.001211: and the Secretary of De- fense a report for such year that includes information on—
p.001211: (A) the number and types of trauma cases managed by military trauma teams or military trauma care providers
p.001211: pursuant to such grant during such year;
p.001211: (B) the ability to maintain the integration of the mili- tary trauma providers or teams of providers as part of the
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p.001213: cen- ter that satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams
p.001213: to provide trauma care and related acute care at such trauma center.
p.001213: (B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which
p.001213: data are available are treated for a major trauma at such trauma center.
p.001213: (C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (D) Such trauma center is an academic training cen- ter—
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p.001213: (i) affiliated with a medical school;
p.001213: (ii) that maintains residency programs and fellow- ships in critical trauma specialties and subspecialties, and
p.001213: provides education and supervision of military trauma team members according to those specialties and
p.001213: subspecialties; and
p.001213: (iii) that undertakes research in the prevention and treatment of traumatic injury.
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001213: Sec. 1301 PUBLIC HEALTH SERVICE ACT 1214
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p.001213: (E) Such trauma center serves as a medical and public health preparedness and response leader for its commu-
p.001213: nity, such as by participating in a partnership for State and regional hospital preparedness established
p.001213: under sec- tion 319C–2 or 319C–3.
p.001213: (2) ELIGIBLE TRAUMA CENTER.—The term ‘‘eligible trauma center’’ means a Level I, II, or III trauma center that
p.001213: satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma care
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p.001213: manner:
p.001213: (1) Each member is to be provided basic health services for a basic health services payment which (A) is to be
p.001213: paid on a periodic basis without regard to the dates health services (within the basic health
p.001213: services) are provided; (B) is fixed without regard to the frequency, extent, or kind of health serv-
p.001213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001215: 1215
p.001215: PUBLIC HEALTH SERVICE ACT
p.001215: Sec. 1301
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p.001215: ice (within the basic health services) actually furnished; (C) ex- cept in the case of basic health services
p.001215: provided a member who is a full-time student (as defined by the Secretary) at an accredited institution of
p.001215: higher education, is fixed under a com- munity rating system; and (D) may be supplemented by addi- tional
p.001215: nominal payments which may be required for the provi- sion of specific services (within the basic health
p.001215: services), ex- cept that such payments may not be required where or in such a manner that they serve (as determined
p.001215: under regulations of the Secretary) as a barrier to the delivery of health services. Such additional nominal
p.001215: payments shall be fixed in accordance with the regulations of the Secretary. If a health maintenance organization
p.001215: offers to its members the opportunity to obtain basic health services through a physician not described in sub-
p.001215: section (b)(3)(A), the organization may require, in addition to payments described in clause (D) of this
p.001215: paragraph, a reason- able deductible to be paid by a member when obtaining a basic health service from such a
p.001215: physician. A health maintenance or- ganization may include a health service, defined as a supple- mental
p.001215: health service by section 1302(2), in the basic health services provided its members for a basic health
p.001215: services pay- ment described in the first sentence. In the case of an entity which before it became a
p.001215: qualified health maintenance organi- zation (within the meaning of section 1310(d)) provided com- prehensive
p.001215: health services on a prepaid basis, the requirement of clause (C) shall not apply to such entity until the expiration
p.001215: of the forty-eight month period beginning with the month fol- lowing the month in which the entity became such
p.001215: a qualified health organization. The requirements of this paragraph re- specting the basic health services
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p.001215: addition to the basic health services payment, the organization may pro- vide to each of its members any
p.001215: of the health services which
p.001215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001215: are included in supplemental health services (as defined in sec- tion 1302(2)). Supplemental health services
p.001215: payments which are fixed on a prepayment basis shall be fixed under a commu- nity rating system unless the
p.001215: supplemental health services payment is for a supplemental health service provided a mem- ber who is a full-time
p.001215: student (as defined by the Secretary) at an accredited institution of higher education, except that, in the
p.001215: case of an entity which before it became a qualified health maintenance organization (within the meaning of
p.001215: section 1310(d)) provided comprehensive health services on a prepaid basis, the requirement of this sentence
p.001215: shall not apply to such entity during the forty-eight month period beginning with the month following the month
p.001215: in which the entity became such a qualified health maintenance organization.
p.001215: (3)(A) Except as provided in subparagraph (B), at least 90 percent of the services of a physician which are
p.001215: provided as basic health services shall be provided through—
p.001215: (i) members of the staff of the health maintenance or- ganization,
p.001215: (ii) a medical group (or groups),
p.001215: (iii) an individual practice association (or associations),
p.001215: (iv) physicians or other health professionals who have contracted with the health maintenance organization for
p.001215: the provision of such services, or
p.001215: (v) any combination of such staff, medical group (or groups), individual practice association (or associations)
p.001215: or physicians or other health professionals under contract with the organization.
p.001215: (B) Subparagraph (A) does not apply to the provision of the services of a physician—
p.001215: (i) which the health maintenance organization deter- mines, in conformity with regulations of the Secretary, are
p.001215: unusual or infrequently used, or
p.001215: (ii) which are provided a member of the organization in a manner other than that prescribed by
p.001215: subparagraph
p.001215: (A) because of an emergency which made it medically nec- essary that the service be provided to the member
p.001215: before it could be provided in a manner prescribed by subpara- graph (A).
p.001215: (C) Contracts between a health maintenance organization and health professionals for the provision of basic and
p.001215: supple- mental health services shall include such provisions as the Sec- retary may require (including provisions
p.001215: requiring appropriate continuing education).
p.001215: (D) Contracts between a health maintenance organization and health professionals for the provision of basic and
p.001215: supple- mental health services shall include such provisions as the Sec- retary may require, but only to the
p.001215: extent that such require- ments are designed to insure the delivery of quality health care services and
p.001215: sound fiscal management.
p.001215: (4) Basic health services (and only such supplemental health services as members have contracted
p.001215: for) shall within the area served by the health maintenance organization be available and accessible to each
p.001215: of its members with reasonable
p.001215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001217: PUBLIC HEALTH SERVICE ACT
p.001217: Sec. 1301
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p.001219: (4) The term ‘‘medical group’’ means a partnership, association, or other group—
p.001219: (A) which is composed of health professionals licensed to practice medicine or osteopathy and of such
p.001219: other licensed health professionals (including dentists, optometrists, podia- trists, and psychologists) as
p.001219: are necessary for the provision of health services for which the group is responsible;
p.001219: (B) a majority of the members of which are licensed to practice medicine or osteopathy; and
p.001219: (C) the members of which (i) as their principal professional activity engage in the coordinated practice of
p.001219: their profession and as a group responsibility have substantial responsibility for the delivery of health
p.001219: services to members of a health maintenance organization, except that this clause does not apply before the
p.001219: end of the forty-eight month period beginning after the month in which the health maintenance oranization 1 becomes a
p.001219: qualified health maintenance organization as de- fined in section 1310(d), or as authorized by the
p.001219: Secretary in accordance with regulations that take into consideration the usual circumstances of the group;
p.001219: (ii) pool their income from practice as members of the group and distribute it among themselves
p.001219: according to a prearranged salary or drawing ac- count or other similar plan unrelated to the provision
p.001219: of spe- cific health services; (iii) share medical and other records and substantial portions of major
p.001219: equipment and of professional, technical, and administrative staff; (iv) arrange for and encour- age continuing
p.001219: education in the field of clinical medicine and related areas for the members of the group; and (v)
p.001219: establish an arrangement whereby a member’s enrollment status is not
p.001219:
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p.001219: 1 So in law. Probably should be ‘‘organization’’.
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001221: PUBLIC HEALTH SERVICE ACT
p.001221: Sec. 1302
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p.001221: known to the health professional who provides health services to the member.
p.001221: (5) The term ‘‘individual practice association’’ means a partner- ship, corporation, association, or other legal
p.001221: entity which has en- tered into a services arrangement (or arrangements) with persons who are licensed to
p.001221: practice medicine, osteopathy, dentistry, podia- try, optometry, psychology, or other health profession in a
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p.001237:
p.001237: øFor Text of This Title See Volume 2 of the Environmental Law Compilation¿
p.001237:
p.001237:
p.001237:
p.001237: January 30, 2020
p.001237: 4 Subsection (e) was repealed by section 810 of Public Law 99–660.
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001237:
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p.001237: Sec. 1501 PUBLIC HEALTH SERVICE ACT 1238
p.001237: TITLE XV—PREVENTIVE HEALTH MEAS- URES WITH RESPECT TO BREAST AND CERVICAL CANCERS
p.001237:
p.001237: SEC. 1501. ø300k¿ ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.
p.001237: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.001237: grants to States on the basis of an established competitive review process for the purpose of carrying out programs—
p.001237: (1) to screen women for breast and cervical cancer as a preventive health measure;
p.001237: (2) to provide appropriate referrals for medical treatment of women screened pursuant to paragraph (1)
p.001237: and to ensure, to the extent practicable, the provision of appropriate follow-up services and support services such
p.001237: as case management;
p.001237: (3) to develop and disseminate public information and edu- cation programs for the detection and control of breast and
p.001237: cer- vical cancer;
p.001237: (4) to improve the education, training, and skills of health professionals (including allied health professionals)
p.001237: in the de- tection and control of breast and cervical cancer;
p.001237: (5) to establish mechanisms through which the States can monitor the quality of screening procedures for breast and
p.001237: cer- vical cancer, including the interpretation of such procedures; and
p.001237:
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p.001237:
p.001237: January 30, 2020
p.001237: (6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or
p.001237: program-moni- toring activities.
p.001237: (b) GRANT AND CONTRACT AUTHORITY OF STATES.—
p.001237: (1) IN GENERAL.—A State receiving a grant under sub- section (a) may, subject to paragraphs (2) and
p.001237: (3), expend the grant to carry out the purpose described in such subsection through grants to public and
p.001237: nonprofit private entities and through contracts with public and private entities.
p.001237: (2) CERTAIN APPLICATIONS.—If a nonprofit private entity and a private entity that is not a nonprofit entity
p.001237: both submit applications to a State to receive an award of a grant or con- tract pursuant to paragraph (1),
p.001237: the State may give priority to the application submitted by the nonprofit private entity in any case in
p.001237: which the State determines that the quality of such application is equivalent to the quality of the application
p.001237: submitted by the other private entity.
...

p.001243: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.001243: (c) STATEWIDE PROVISION OF SERVICES.—
p.001243: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001243:
p.001243:
p.001243:
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p.001243: Sec. 1504 PUBLIC HEALTH SERVICE ACT 1244
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p.001243: January 30, 2020
p.001243:
p.001243: (1) IN GENERAL.—The Secretary may not make a grant under section 1501 unless the State involved agrees that
p.001243: serv- ices and activities under the grant will be made available throughout the State, including availability
p.001243: to members of any Indian tribe or tribal organization (as such terms are defined in section 4 of the
p.001243: Indian Self-Determination and Education Assistance Act).
p.001243: (2) WAIVER.—The Secretary may waive the requirement established in paragraph (1) for a State if the Secretary
p.001243: deter- mines that compliance by the State with the requirement would result in an inefficient allocation
p.001243: of resources with re- spect to carrying out the purpose described in section 1501(a).
p.001243: (3) GRANTS TO TRIBES AND TRIBAL ORGANIZATIONS.—
p.001243: (A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may
p.001243: make grants to tribes and tribal organizations (as such terms are used in paragraph (1)) for the purpose of carrying
p.001243: out pro- grams described in section 1501(a). This title applies to such a grant (in relation to the
p.001243: jurisdiction of the tribe or organization) to the same extent and in the same manner as such title applies to a
p.001243: grant to a State under section 1501 (in relation to the jurisdiction of the State).
p.001243: (B) If a tribe or tribal organization is receiving a grant under subparagraph (A) and the State in which the
p.001243: tribe or organization is located is receiving a grant under sec- tion 1501, the requirement established in
p.001243: paragraph (1) for the State regarding the tribe or organization is deemed to have been waived under paragraph (2).
p.001243: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—The Secretary may not make a grant under
p.001243: section 1501 unless the State involved agrees that the grant will not be ex- pended to make payment for any
p.001243: item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to
p.001243: such item or service—
p.001243: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
...

p.001245: the source of the contributions; and
p.001245: (B) the proportion of such amount of non-Federal con- tributions relative to the amount of Federal funds provided
p.001245: through the grant to the State for the preceding fiscal year.
p.001245: (b) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date of the enactment of the
p.001245: National Breast and Cervical Cancer Early Detection Program Reauthorization of 2007, and annually thereafter,
p.001245: submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on
p.001245: Labor and Human Resources of the Senate, a report summa- rizing evaluations carried out pursuant to subsection
p.001245: (a) during the preceding fiscal year and making such recommendations for admin- istrative and legislative
p.001245: initiatives with respect to this title as the Secretary determines to be appropriate, including recommendations
p.001245: regarding compliance by the States with section 1501(a)(2) and with section 1504(c).
p.001245: SEC. 1509. ø300n–4a¿ SUPPLEMENTAL GRANTS FOR ADDITIONAL PRE- VENTIVE HEALTH SERVICES.
p.001245: (a) DEMONSTRATION PROJECTS.—In the case of States receiving grants under section 1501, the Secretary, acting through
p.001245: the Direc- tor of the Centers for Disease Control and Prevention, may make grants to not more than 3
p.001245: such States to carry out demonstration projects for the purpose of—
p.001245: (1) providing preventive health services in addition to the services authorized in such section, including
p.001245: screenings re- garding blood pressure and cholesterol, and including health education;
p.001245: (2) providing appropriate referrals for medical treatment of women receiving services pursuant to paragraph (1) and
p.001245: ensur-
p.001245: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001245:
p.001245:
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p.001245:
p.001247: 1247
p.001247: PUBLIC HEALTH SERVICE ACT
p.001247: Sec. 1601
p.001247:
p.001247: ing, to the extent practicable, the provision of appropriate fol- low-up services; and
p.001247: (3) evaluating activities conducted under paragraphs (1) and (2) through appropriate surveillance or
p.001247: program-moni- toring activities.
p.001247: (b) STATUS AS PARTICIPANT IN PROGRAM REGARDING BREAST AND CERVICAL CANCER.—The Secretary may not
p.001247: make a grant under subsection (a) unless the State involved agrees that services under the grant will be
p.001247: provided only through entities that are screening women for breast or cervical cancer pursuant to a
p.001247: grant under section 1501.
p.001247: (c) APPLICABILITY OF PROVISIONS OF GENERAL PROGRAM.—This title applies to a grant under subsection (a) to the same
p.001247: extent and in the same manner as such title applies to a grant under section 1501.
p.001247: (d) FUNDING.—
p.001247: (1) IN GENERAL.—Subject to paragraph (2), for the purpose of carrying out this section, there are authorized
p.001247: to be appro- priated $3,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years
p.001247: 1995 through 2003.
...

p.001261: this title
p.001261: shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount
p.001261: and disposition by such en- tity of the proceeds of such assistance, the total cost of the project in connection with
p.001261: which such assistance is given or used, the amount of that portion of the cost of the project
p.001261: supplied by other sources, and such other records as will facilitate an effective audit.
p.001261: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.001261: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.001261: records of such entities which in the opinion of the Secretary or the Comptroller General may be related or
p.001261: perti- nent to the assistance referred to in paragraph (1).
p.001261: (c) Each such entity shall file at least annually with the Sec- retary a statement which shall be in
p.001261: such form, and contain such information, as the Secretary may require to accurately show—
p.001261: (1) the financial operations of the facility constructed or modernized with such assistance, and
p.001261: (2) the costs to such facility of providing health services in such facility, and the charges made for such
p.001261: services, during the period with respect to which the statement is filed.
p.001261: TECHNICAL ASSISTANCE
p.001261: SEC. 1626. ø300s–5¿ The Secretary shall provide (either through the Department of Health, Education,
p.001261: and Welfare or by contract) all necessary technical and other nonfinancial assistance to any public or
p.001261: other entity which is eligible to apply for assist- ance under this title to assist such entity in developing
p.001261: applications to be submitted to the Secretary under section 1621 or 1642. The Secretary shall make every
p.001261: effort to inform eligible applicants of the availability of assistance under this title.
p.001261:
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p.001261: January 30, 2020
p.001261: ENFORCEMENT OF ASSURANCES
p.001261: SEC. 1627. ø300s–6¿ The Secretary shall investigate and ascer- tain, on a periodic basis, with respect to each
p.001261: entity which is re- ceiving financial assistance under this title or which has received financial
p.001261: assistance under title VI or this title, the extent of compli- ance by such entity with the assurances required to be
p.001261: made at the time such assistance was received. If the Secretary finds that such an entity has failed to comply
p.001261: with any such assurance, the Sec- retary shall report such noncompliance to the health systems agen- cy for the
p.001261: health service area in which such entity is located and the State health planning and development agency
p.001261: of the State in which the entity is located and shall take any action authorized by law (including an action for
p.001261: specific performance brought by the At- torney General upon request of the Secretary) which will effect
...

p.001265: rights of employees under collective- bargaining agreements, continuation of collective-bargaining rights
p.001265: consistent with the provisions of the National Labor Relations Act, reassignment of affected employees to other
p.001265: jobs, retraining pro- grams, protecting pension, health benefits, and other fringe bene- fits of affected
p.001265: employees, and arranging adequate severance pay, if necessary.
p.001265: (2) The Secretary of Labor shall by regulation prescribe guide- lines for arrangements for the protection of the
p.001265: interests of employ- ees affected by the discontinuance of hospital services. The Sec- retary of Labor
p.001265: shall consult with the Secretary of Health, Edu- cation, and Welfare in the promulgation of such
p.001265: guidelines. Such guidelines shall first be promulgated not later than the promulga- tion of regulations by
p.001265: the Secretary for the administration of the grants authorized by section 1641.
p.001265: (3) The Secretary of Labor shall review each application sub- mitted under subsection (b) to determine
p.001265: if the arrangements de- scribed in paragraph (1) have been made and if they are satisfac- tory and
p.001265: shall notify the Secretary respecting his determination. Such review shall be completed within—
p.001265: (A) ninety days from the date of the receipt of the applica- tion from the Secretary of Health, Education, and
p.001265: Welfare, or
p.001265: (B) one hundred and twenty days from such date if the Secretary of Labor has by regulation
p.001265: prescribed the cir- cumstances under which the review will require at least one hundred and twenty days.
p.001265: If within the applicable period, the Secretary of Labor does not no- tify the Secretary of Health, Education, and
p.001265: Welfare respecting his determination, the Secretary of Health, Education, and Welfare shall review the
p.001265: application to determine if the applicant has made the arrangements described in paragraph (1) and if such
p.001265: arrange- ments are satisfactory. The Secretary may not approve the applica- tion unless he determines that such
p.001265: arrangements have been made and that they are satisfactory.
p.001265: (d) The records and audits requirements of section 705 shall apply with respect to grants made under
p.001265: subsection (a).
p.001265: (e) For purposes of this part, the term ‘‘hospital’’ means, with respect to any fiscal year, an
p.001265: institution (including a distinct part of an institution participating in the programs established under
p.001265: title XVIII of the Social Security Act)—
p.001265: (1) which satisfies paragraphs (1) and (7) of section 1861(e) of such Act,
p.001265: (2) imposes charges or accepts payments for services pro- vided to patients, and
p.001265: (3) the average duration of a patient’s stay in which was thirty days or less in the preceding fiscal year,
p.001265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001265:
p.001265:
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p.001265: Sec. 1643 PUBLIC HEALTH SERVICE ACT 1266
p.001265:
p.001265: but such term does not include a Federal hospital or a psychiatric hospital (as described in section 1861(f)(1)
p.001265: of the Social Security Act).
p.001265: GRANTS TO STATES FOR REDUCTION OF EXCESS HOSPITAL CAPACITY
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p.001265: (4) developing means to overcome barriers to the reduction of excess hospital capacity,
p.001265: (5) in planning, evaluating, and carrying out programs to decertify health care facilities providing
p.001265: health services that are not appropriate, and
p.001265: (6) any other activity related to the reduction of excess hospital capacity.
p.001265: (b) Grants under subsection (a) shall be made on such terms and conditions as the Secretary may prescribe.
p.001265: AUTHORIZATION OF APPROPRIATIONS
p.001265: SEC. 1644. ø300t–14¿ To make payments under grants under sections 1642 and 1643 there are authorized to
p.001265: be appropriated
p.001265: $30,000,000 for the fiscal year ending September 30, 1980,
p.001265: $50,000,000 for the fiscal year ending September 30, 1981, and
p.001265: $75,000,000 for the fiscal year ending September 30, 1982, except that in any fiscal year not more than 10
p.001265: percent of the amount ap- propriated under this section may be obligated for grants under section 1643.
p.001265: TITLE XVII—HEALTH INFORMATION AND HEALTH PROMOTION
p.001265:
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p.001265: January 30, 2020
p.001265: GENERAL AUTHORITY
p.001265: SEC. 1701. ø300u¿ (a) The Secretary shall—
p.001265: (1) formulate national goals, and a strategy to achieve such goals, with respect to health information and
p.001265: health pro- motion, preventive health services, and education in the appro- priate use of health care;
p.001265: (2) analyze the necessary and available resources for im- plementing the goals and strategy
p.001265: formulated pursuant to paragraph (1), and recommend appropriate educational and quality assurance policies
p.001265: for the needed manpower resources identified by such analysis;
p.001265: (3) undertake and support necessary activities and pro- grams to—
p.001265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001265:
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p.001267: 1267
p.001267: PUBLIC HEALTH SERVICE ACT
p.001267: Sec. 1701
p.001267:
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p.001267: January 30, 2020
p.001267: (A) incorporate appropriate health education compo- nents into our society, especially into all aspects of
p.001267: edu- cation and health care,
p.001267: (B) increase the application and use of health knowl- edge, skills, and practices by the general population in
p.001267: its patterns of daily living, and
p.001267: (C) establish systematic processes for the exploration, development, demonstration, and evaluation of
p.001267: innovative health promotion concepts;
p.001267: (4) undertake and support research and demonstrations re- specting health information and health promotion,
p.001267: preventive health services, and education in the appropriate use of health care;
p.001267: (5) undertake and support appropriate training in the op- eration of programs concerned with, health
p.001267: information and health promotion, preventive health services, and education in the appropriate use of health care;
p.001267: (6) undertake and support, through improved planning and implementation of tested models and evaluation of
p.001267: results, ef- fective and efficient programs respecting health information and health promotion, preventive
p.001267: health services, and edu- cation in the appropriate use of health care;
p.001267: (7)(A) develop model programs through which employers in the public sector, and employers that are small businesses (as
p.001267: defined in section 3 of the Small Business Act), can provide for their employees a program to promote healthy
p.001267: behaviors and to discourage participation in unhealthy behaviors;
p.001267: (B) provide technical assistance to public and private em- ployers in implementing such programs (including
p.001267: private em- ployers that are not small businesses and that will implement programs other than the programs developed by
p.001267: the Secretary pursuant to subparagraph (A)); and
p.001267: (C) in providing such technical assistance, give preference to small businesses;
p.001267: (8) foster the exchange of information respecting, and fos- ter cooperation in the conduct of, research,
p.001267: demonstration, and training programs respecting health information and health promotion, preventive health
p.001267: services, and education in the ap- propriate use of health care;
p.001267: (9) provide technical assistance in the programs referred to in paragraph (8);
p.001267: (10) use such other authorities for programs respecting health information and health promotion, preventive
p.001267: health services, and education in the appropriate use of health care as are available and coordinate
p.001267: such use with programs con- ducted under this title; and
p.001267: (11) establish in the Office of the Assistant Secretary for Health an Office of Disease Prevention and Health
p.001267: Promotion, which shall—
p.001267: (A) coordinate all activities within the Department which relate to disease prevention, health promotion,
p.001267: pre- ventive health services, and health information and edu- cation with respect to the appropriate use
p.001267: of health care;
p.001267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001267:
p.001267:
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p.001267: Sec. 1702 PUBLIC HEALTH SERVICE ACT 1268
p.001267:
p.001267: (B) coordinate such activities with similar activities in the private sector;
p.001267: (C) establish a national information clearinghouse to facilitate the exchange of information concerning
p.001267: matters relating to health information and health promotion, pre- ventive health services (which may
p.001267: include information concerning models and standards for insurance coverage of such services), and education in
p.001267: the appropriate use of health care, to facilitate access to such information, and to assist in the analysis of
p.001267: issues and problems relating to such matters; and
p.001267: (D) support projects, conduct research, and dissemi- nate information relating to preventive medicine,
p.001267: health promotion, and physical fitness and sports medicine.
p.001267: The Secretary shall appoint a Director for the Office of Disease Prevention and Health Promotion
p.001267: established pursuant to para- graph (11) of this subsection. The Secretary shall administer this title in
p.001267: cooperation with health care providers, educators, voluntary organizations, businesses, and State and local
p.001267: health agencies in order to encourage the dissemination of health information and health promotion
p.001267: activities.
p.001267: (b) For the purpose of carrying out this section and sections 1702 through 1705, there are
p.001267: authorized to be appropriated
p.001267: $10,000,000 for fiscal year 1992, and such sums as may be nec- essary for each of the fiscal years 1993
p.001267: through 2002.
p.001267: (c) No grant may be made or contract entered into under this title unless an application therefor has
p.001267: been submitted to and ap- proved by the Secretary. Such an application shall be submitted in such form and
p.001267: manner and contain such information as the Sec- retary may prescribe. Contracts may be entered into
p.001267: under this title without regard to sections 3648 and 3709 of the Revised Stat- utes (31 U.S.C. 529; 41 U.S.C. 5).
p.001267:
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p.001267: January 30, 2020
p.001267:
p.001267: RESEARCH PROGRAMS
p.001267: SEC. 1702. ø300u–1¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001267: to support) research in health information and health promotion, preventive health services, and education
p.001267: in the appropriate use of health care. Applications for grants and contracts under this section shall be subject
p.001267: to appropriate peer review. The Secretary shall also—
p.001267: (1) provide consultation and technical assistance to per- sons who need help in preparing research proposals or
p.001267: in actu- ally conducting research;
p.001267: (2) determine the best methods of disseminating informa- tion concerning personal health behavior,
p.001267: preventive health services and the appropriate use of health care and of affecting behavior so that such
p.001267: information is applied to maintain and improve health, and prevent disease, reduce its risk, or modify its course
p.001267: or severity;
p.001267: (3) determine and study environmental, occupational, so- cial, and behavioral factors which affect and
p.001267: determine health and ascertain those programs and areas for which educational
p.001267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001267:
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p.001269: 1269
p.001269: PUBLIC HEALTH SERVICE ACT
p.001269: Sec. 1703
p.001269:
p.001269: and preventive measures could be implemented to improve health as it is affected by such factors;
p.001269: (4) develop (A) methods by which the cost and effectiveness of activities respecting health information and
p.001269: health pro- motion, preventive health services, and education in the appro- priate use of health care, can be
p.001269: measured, including methods for evaluating the effectiveness of various settings for such ac- tivities and the various
p.001269: types of persons engaged in such activi- ties, (B) methods for reimbursement or payment for such ac- tivities,
p.001269: and (C) models and standards for the conduct of such activities, including models and standards for the
p.001269: education, by providers of institutional health services, of individuals receiv- ing such services respecting the
p.001269: nature of the institutional health services provided the individuals and the symptoms, signs, or diagnoses
p.001269: which led to provision of such services;
p.001269: (5) develop a method for assessing the cost and effective- ness of specific medical services and procedures
p.001269: under various conditions of use, including the assessment of the sensitivity and specificity of screening and
p.001269: diagnostic procedures; and
p.001269: (6) enumerate and assess, using methods developed under paragraph (5), preventive health measures and services
p.001269: with respect to their cost and effectiveness under various conditions of use (which measures and services may
p.001269: include blood pres- sure screening, cholesterol screening and control, smoking ces- sation programs, substance
p.001269: abuse programs, cancer screening, dietary and nutritional counseling, diabetes screening and edu- cation,
p.001269: intraocular pressure screening, and stress manage- ment).
p.001269: (b) The Secretary shall make a periodic survey of the needs, in- terest, attitudes, knowledge, and behavior of
p.001269: the American public regarding health and health care. The Secretary shall take into consideration the
p.001269: findings of such surveys and the findings of simi- lar surveys conducted by national and community health education
p.001269: organizations, and other organizations and agencies for formulating policy respecting health information and health
p.001269: promotion, preven- tive health services, and education in the appropriate use of health care.
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p.001269: January 30, 2020
p.001269:
p.001269: COMMUNITY PROGRAMS
p.001269:
p.001269: SEC. 1703. ø300u–2¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001269: to support) new and innovative programs in health information and health promotion, preventive health services,
p.001269: and education in the appro- priate use of health care, and may specifically—
p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
p.001269: appropriate settings representative of broad cross sections of the population, and include public edu- cation
p.001269: activities of voluntary health agencies, professional med- ical societies, and other private nonprofit health
p.001269: organizations,
p.001269: (B) focus on objectives that are measurable, and (C) emphasize
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001269:
p.001269:
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p.001269: Sec. 1704 PUBLIC HEALTH SERVICE ACT 1270
p.001269:
p.001269: the prevention or moderation of illness or accidents that ap- pear controllable through individual
p.001269: knowledge and behavior;
p.001269: (2) provide consultation and technical assistance to organi- zations that request help in planning, operating, or
p.001269: evaluating programs in such matters;
p.001269: (3) develop health information and health promotion mate- rials and teaching programs including (A) model
p.001269: curriculums for the training of educational and health professionals and paraprofessionals in health
p.001269: education by medical, dental, and nursing schools, schools of public health, and other institutions engaged in
p.001269: training of educational or health professionals, (B) model curriculums to be used in elementary and
p.001269: secondary schools and institutions of higher learning, (C) materials and programs for the continuing
p.001269: education of health professionals and paraprofessionals in the health education of their patients,
p.001269: (D) materials for public service use by the printed and broad- cast media, and (E) materials and programs to
p.001269: assist providers of health care in providing health education to their patients; and
p.001269: (4) support demonstration and evaluation programs for in-
p.001269: dividual and group self-help programs designed to assist the participant in using his individual
p.001269: capacities to deal with health problems, including programs concerned with obesity, hypertension, and
p.001269: diabetes.
p.001269: (b) The Secretary is authorized to make grants to States and other public and nonprofit entities to
p.001269: assist them in meeting the costs of demonstrating and evaluating programs which provide in- formation
p.001269: respecting the costs and quality of health care or infor- mation respecting health insurance policies and
p.001269: prepaid health plans, or information respecting both. After the development of models pursuant to sections
p.001269: 1704(4) and 1704(5) for such informa- tion, no grant may be made under this subsection for a program unless
p.001269: the information to be provided under the program is pro- vided in accordance with one of such models
p.001269: applicable to the infor- mation.
p.001269: (c) The Secretary is authorized to support by grant or contract (and to encourage others to support) private
p.001269: nonprofit entities working in health information and health promotion, preventive health services, and
p.001269: education in the appropriate use of health care. The amount of any grant or contract for a fiscal year
p.001269: begin- ning after September 30, 1978, for an entity may not exceed 25 per centum of the expenses of entity for such
p.001269: fiscal year for health in- formation and health promotion, preventive health services, and education in the
p.001269: appropriate use of health care.
p.001269:
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p.001269: January 30, 2020
p.001269: INFORMATION PROGRAMS
p.001269: SEC. 1704. ø300u–3¿ The Secretary is authorized to conduct and support by grant or contract (and encourage
p.001269: others to support) such activities as may be required to make information respecting health information and
p.001269: health promotion, preventive health serv- ices, and education in the appropriate use of health care available to
p.001269: the consumers of medical care, providers of such care, schools,
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001271: 1271
p.001271: PUBLIC HEALTH SERVICE ACT
p.001271: Sec. 1705
p.001271:
p.001271: and others who are or should be informed respecting such matters. Such activities may include at least the following:
p.001271: (1) The publication of information, pamphlets, and other reports which are specially suited to interest
p.001271: and instruct the health consumer, which information, pamphlets, and other re- ports shall be updated
p.001271: annually, shall pertain to the individ- ual’s ability to improve and safeguard his own health; shall in- clude
p.001271: material, accompanied by suitable illustrations, on child care, family life and human development, disease
p.001271: prevention (particularly prevention of pulmonary disease, cardiovascular disease, and cancer), physical
p.001271: fitness, dental health, environ- mental health, nutrition, safety and accident prevention, drug abuse and
p.001271: alcoholism, mental health, management of chronic diseases (including diabetes and arthritis), and venereal
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p.001271: agencies and others such recommendations respecting such advertising as are appropriate.
p.001271: (4) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others (except individual health practitioners) of information for use by the public respecting the
p.001271: cost and quality of health care, including information to enable the public to make com- parisons of the
p.001271: cost and quality of health care.
p.001271: (5) The development of models and standards for the publi- cation by States, insurance carriers, prepaid health plans,
p.001271: and others of information for use by the public respecting health in- surance policies and prepaid health plans,
p.001271: including informa- tion on the benefits provided by the various types of such poli- cies and plans, the premium
p.001271: charges for such policies and plans, exclusions from coverage or eligibility for coverage, cost sharing
p.001271: requirements, and the ratio of the amounts paid as benefits to the amounts received as premiums and information
p.001271: to enable the public to make relevant comparisons of the costs and benefits of such policies and plans.
p.001271:
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p.001271: January 30, 2020
p.001271:
p.001271: REPORT AND STUDY
p.001271: SEC. 1705. ø300u–4¿ (a) The Secretary shall, not later than two years after the date of the enactment
p.001271: of this title and bian- nually thereafter, submit to the President for transmittal to Con- gress a
p.001271: report on the status of health information and health pro- motion, preventive health services, and
p.001271: education in the appro- priate use of health care. Each such report shall include—
p.001271: (1) a statement of the activities carried out under this title since the last report and the extent to which each such
p.001271: activity achieves the purposes of this title;
p.001271: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001271:
p.001271: Sec. 1706 PUBLIC HEALTH SERVICE ACT 1272
p.001271:
p.001271: (2) an assessment of the manpower resources needed to carry out programs relating to health information
p.001271: and health promotion, preventive health services, and education in the ap- propriate use of health care, and a
p.001271: statement describing the ac- tivities currently being carried out under this title designed to prepare teachers and
p.001271: other manpower for such programs;
p.001271: (3) the goals and strategy formulated pursuant to section 1701(a)(1), the models and standards developed
p.001271: under this title, and the results of the study required by subsection (b) of this section; and
p.001271: (4) such recommendations as the Secretary considers ap- propriate for legislation respecting health
p.001271: information and health promotion, preventive health services, and education in the appropriate use of health care,
p.001271: including recommendations for revisions to and extension of this title.
p.001271: (b) The Secretary shall conduct a study of health education services and preventive health services to
p.001271: determine the coverage of such services under public and private health insurance pro- grams, including
p.001271: the extent and nature of such coverage and the cost sharing requirements required by such programs for
p.001271: coverage of such services.
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p.001271: January 30, 2020
p.001271:
p.001271: CENTERS FOR RESEARCH AND DEMONSTRATION OF HEALTH PROMOTION AND DISEASE PREVENTION
p.001271: SEC. 1706. ø300u–5¿ (a) The Secretary shall make grants or enter into contracts with academic health centers
p.001271: for the establish- ment, maintenance, and operation of centers for research and dem- onstration with respect to health
p.001271: promotion and disease prevention. Centers established, maintained, or operated under this section shall
p.001271: undertake research and demonstration projects in health pro- motion, disease prevention, and improved methods of
p.001271: appraising health hazards and risk factors, and shall serve as demonstration sites for the use of new
p.001271: and innovative research in public health techniques to prevent chronic diseases.
p.001271: (b) Each center established, maintained, or operated under this section shall—
p.001271: (1) be located in an academic health center with—
p.001271: (A) a multidisciplinary faculty with expertise in public health and which has working relationships with relevant
p.001271: groups in such fields as medicine, psychology, nursing, so- cial work, education and business;
p.001271: (B) graduate training programs relevant to disease prevention;
p.001271: (C) a core faculty in epidemiology, biostatistics, social sciences, behavioral and environmental health
p.001271: sciences, and health administration;
p.001271: (D) a demonstrated curriculum in disease prevention;
p.001271: (E) a capability for residency training in public health or preventive medicine; and
p.001271: (F) such other qualifications as the Secretary may pre- scribe;
p.001271: (2) conduct—
p.001271: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001273: 1273
p.001273: PUBLIC HEALTH SERVICE ACT
p.001273: Sec. 1707
p.001273:
p.001273: (A) health promotion and disease prevention research, including retrospective studies and longitudinal prospec-
p.001273: tive studies in population groups and communities;
p.001273: (B) demonstration projects for the delivery of services relating to health promotion and disease prevention to
p.001273: de- fined population groups using, as appropriate, community outreach and organization techniques and other
p.001273: methods of educating and motivating communities; and
p.001273: (C) evaluation studies on the efficacy of demonstration projects conducted under subparagraph (B) of this para-
p.001273: graph.
p.001273: The design of any evaluation study conducted under subparagraph
p.001273: (C) shall be established prior to the commencement of the dem- onstration project under subparagraph (B) for
p.001273: which the evaluation will be conducted.
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p.001273: of activities aimed at reducing health disparities and supporting the local community. Such measures shall
p.001273: evaluate community outreach activities, language services, workforce cul- tural competence, and other areas as
p.001273: determined by the Secretary.
p.001273: (b) DUTIES.—With respect to improving the health of racial and ethnic minority groups, the Secretary, acting
p.001273: through the Deputy Assistant Secretary for Minority Health (in this section referred to as the ‘‘Deputy Assistant
p.001273: Secretary’’), shall carry out the following:
p.001273: (1) Establish short-range and long-range goals and objec- tives and coordinate all other activities
p.001273: within the Public Health Service that relate to disease prevention, health pro- motion, service delivery,
p.001273: and research concerning such individ- uals. The heads of each of the agencies of the Service shall con- sult with the
p.001273: Deputy Assistant Secretary to ensure the coordi- nation of such activities.
p.001273: (2) Enter into interagency agreements with other agencies of the Public Health Service.
p.001273: (3) Support research, demonstrations and evaluations to test new and innovative models.
p.001273: (4) Increase knowledge and understanding of health risk factors.
p.001273: (5) Develop mechanisms that support better information dissemination, education, prevention, and service
p.001273: delivery to individuals from disadvantaged backgrounds, including indi- viduals who are members of racial
p.001273: or ethnic minority groups.
p.001273: (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority
p.001273: group.
p.001273: (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts
p.001273: with public and nonprofit private providers of primary health services for the purpose of increasing the access
p.001273: of the individuals to such services by developing and carrying out programs to provide bi- lingual or interpretive
p.001273: services.
p.001273: (8) Support a national minority health resource center to carry out the following:
p.001273: (A) Facilitate the exchange of information regarding matters relating to health information and health
p.001273: pro- motion, preventive health services, and education in the appropriate use of health care.
p.001273: (B) Facilitate access to such information.
p.001273: (C) Assist in the analysis of issues and problems relat- ing to such matters.
p.001273: (D) Provide technical assistance with respect to the ex- change of such information (including facilitating the
p.001273: de- velopment of materials for such technical assistance).
p.001273: (9) Carry out programs to improve access to health care services for individuals with limited proficiency in
p.001273: speaking the English language. Activities under the preceding sentence shall include developing and evaluating model
p.001273: projects.
p.001273: (10) Advise in matters related to the development, imple- mentation, and evaluation of health professions
p.001273: education in
p.001273: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: 1275
p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
p.001275: (2) DUTIES.—The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section,
p.001275: including advice on the development of goals and specific program activi- ties under paragraphs (1) through (10)
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p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
p.001275: (1) RECOMMENDATIONS REGARDING LANGUAGE.—
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1276
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p.001275: January 30, 2020
p.001275:
p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
p.001275: the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other
p.001275: appro- priate departmental entities regarding recommendations for carrying out activities under subsection (b)(9).
p.001275: (B) HEALTH PROFESSIONS EDUCATION REGARDING HEALTH DISPARITIES.—The Deputy Assistant Secretary
p.001275: shall carry out the duties under subsection (b)(10) in col- laboration with appropriate personnel of the
p.001275: Department of Health and Human Services, other Federal agencies, and other offices, centers, and institutions,
p.001275: as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and
p.001275: Education Act of 2000.
p.001275: (2) EQUITABLE ALLOCATION REGARDING ACTIVITIES.—In car- rying out subsection (b), the Secretary shall ensure
p.001275: that serv- ices provided under such subsection are equitably allocated among all groups served under this
p.001275: section by the Secretary.
p.001275: (3) CULTURAL COMPETENCY OF SERVICES.—The Secretary shall ensure that information and services provided
p.001275: pursuant to subsection (b) are provided in the language, educational, and cultural context that is most appropriate for
p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
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p.001277: pended by a minority health office include the costs of employ- ing staff for such office.
p.001277: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001277:
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p.001277: Sec. 1708 PUBLIC HEALTH SERVICE ACT 1278
p.001277:
p.001277: OFFICE OF ADOLESCENT HEALTH
p.001277: SEC. 1708. ø300u–7¿ (a) IN GENERAL.—There is established an Office of Adolescent Health within the Office of
p.001277: the Assistant Sec- retary for Health, which office shall be headed by a director ap- pointed by the
p.001277: Secretary. The Secretary shall carry out this section acting through the Director of such Office.
p.001277: (b) DUTIES.—With respect to adolescent health, the Secretary shall—
p.001277:
p.001277:
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p.001277: January 30, 2020
p.001277: (1) coordinate all activities within the Department of Health and Human Services that relate to
p.001277: disease prevention, health promotion, preventive health services, and health infor- mation and education with
p.001277: respect to the appropriate use of health care, including coordinating—
p.001277: (A) the design of programs, support for programs, and the evaluation of programs;
p.001277: (B) the monitoring of trends;
p.001277: (C) projects of research (including multidisciplinary projects) on adolescent health; and
p.001277: (D) the training of health providers who work with adolescents, particularly nurse practitioners, physician as-
p.001277: sistants, and social workers;
p.001277: (2) coordinate the activities described in paragraph (1) with similar activities in the private sector; and
p.001277: (3) support projects, conduct research, and disseminate in- formation relating to preventive medicine, health
p.001277: promotion, and physical fitness and sports medicine.
p.001277: (c) CERTAIN DEMONSTRATION PROJECTS.—
p.001277: (1) IN GENERAL.—In carrying out subsection (b)(3), the Sec- retary may make grants to carry out demonstration projects
p.001277: for the purpose of improving adolescent health, including projects to train health care providers in
p.001277: providing services to adoles- cents and projects to reduce the incidence of violence among adolescents,
p.001277: particularly among minority males.
p.001277: (2) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out paragraph (1), there are authorized to be
p.001277: appro- priated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994
p.001277: through 1997.
p.001277: (d) INFORMATION CLEARINGHOUSE.—In carrying out subsection (b), the Secretary shall establish and maintain a
p.001277: National Informa- tion Clearinghouse on Adolescent Health to collect and disseminate to health professionals and
...

p.001279: (1) unique to adolescents, or more serious or more preva- lent in adolescents;
p.001279: (2) for which the factors of medical risk or types of medical intervention are different for adolescents, or for which
p.001279: it is un- known whether such factors or types are different for adoles- cents; or
p.001279: (3) with respect to which there has been insufficient clin- ical research involving adolescents as
p.001279: subjects or insufficient clinical data on adolescents.
p.001279: BIENNIAL REPORT REGARDING NUTRITION AND HEALTH
p.001279: SEC. 1709. ø300u–8¿ (a) BIENNIAL REPORT.—The Secretary
p.001279: shall require the Surgeon General of the Public Health Service to prepare biennial reports on the
p.001279: relationship between nutrition and health. Such reports may, with respect to such relationship, include any
p.001279: recommendations of the Secretary and the Surgeon General.
p.001279: (b) SUBMISSION TO CONGRESS.—The Secretary shall ensure that, not later than February 1 of 1995 and
p.001279: of every second year thereafter, a report under subsection (a) is submitted to the Com- mittee on
p.001279: Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the
p.001279: Senate.
p.001279:
p.001279:
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p.001279: January 30, 2020
p.001279:
p.001279: EDUCATION REGARDING DES
p.001279: SEC. 1710. ø300u–9¿ (a) IN GENERAL.—The Secretary, acting through the heads of the appropriate agencies of the
p.001279: Public Health Service, shall carry out a national program for the education of health professionals and
p.001279: the public with respect to the drug diethylstilbestrol (commonly known as DES). To the extent
p.001279: appro- priate, such national program shall use methodologies developed through the education demonstration
p.001279: program carried out under section 403C. In developing and carrying out the national program, the Secretary shall
p.001279: consult closely with representatives of nonprofit private entities that represent individuals who have been
p.001279: exposed to DES and that have expertise in community-based information campaigns for the public and for health
p.001279: care providers. The imple- mentation of the national program shall begin during fiscal year 1999.
p.001279: (b) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001279: to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The
p.001279: authorization of appropriations established in the preceding sentence is in addition to any other authorization of
p.001279: appropriation that is available for such purpose.
p.001279: SEC. 1711. ø300u–16¿ ESTABLISHMENT OF SUBSTANCE USE DISORDER INFORMATION DASHBOARD.
p.001279: (a) IN GENERAL.—Not later than 6 months after the date of the enactment of this section, the Secretary of Health
p.001279: and Human Services shall, in consultation with the Director of National Drug Control Policy, establish
p.001279: and periodically update, on the Internet website of the Department of Health and Human Services, a public
p.001279: information dashboard that—
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
p.001279:
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p.001279: eleven members appointed by the President. The mem- bers of the Commission shall be appointed as follows:
p.001279: (A) Three of the members shall be appointed from individ- uals who are distinguished in biomedical or behavioral
p.001279: re- search.
p.001279: (B) Three of the members shall be appointed from individ- uals who are distinguished in the practice of medicine or
p.001279: other- wise distinguished in the provision of health care.
p.001279: (C) Five of the members shall be appointed from individ- uals who are distinguished in one or more of the
p.001279: fields of eth-
p.001279:
p.001279:
p.001279:
p.001279:
p.001279: January 30, 2020
p.001279: 1 Such a Commission was established on December 17, 1979, by Executive Order No. 12184 (44 Fed. Reg.
p.001279: 75091). The Executive Order was revoked on February 25, 1986, by Executive Order No. 12553 (51 Fed. Reg.
p.001279: 7237).
p.001279: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001279:
p.001279:
p.001279:
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p.001279:
p.001279:
p.001281: 1281
p.001281: PUBLIC HEALTH SERVICE ACT
p.001281: Sec. 1802
p.001281:
p.001281: ics, theology, law, the natural sciences (other than a biomedical or behavioral science), the social
p.001281: sciences, the humanities, health administration, government, and public affairs.
p.001281: (2) No individual who is a full-time officer or employee of the United States may be appointed as a
p.001281: member of the Commission. The Secretary of Health, Education, and Welfare, the Secretary of Defense, the
p.001281: Director of Central Intelligence, the Director of the Of- fice of Science and Technology Policy, the
p.001281: Administrator of Vet- erans’ Affairs, and the Director of the National Science Foundation shall each designate an
p.001281: individual to provide liaison with the Com- mission.
p.001281: (3) No individual may be appointed to serve as a member of the Commission if the individual has served
p.001281: for two terms of four years each as such a member.
p.001281: (4) A vacancy in the Commission shall be filled in the manner in which the original appointment was made.
p.001281: (b) TERMS.—(1) Except as provided in paragraphs (2) and (3), members shall be appointed for terms of four
p.001281: years.
p.001281: (2) Of the members first appointed—
p.001281: (A) four shall be appointed for terms of three years, and
p.001281: (B) three shall be appointed for terms of two years, as designated by the President at the time of appointment.
p.001281: (3) Any member appointed to fill a vacancy occurring before the expiration of the term for which his
p.001281: predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the
p.001281: expiration of his term until his successor has taken office.
p.001281: (c) CHAIRMAN.—The Chairman of the Commission shall be ap- pointed by the President, by and with the advice and consent
p.001281: of the Senate, from members of the Commission.
p.001281: (d) MEETINGS.—(1) Seven members of the Commission shall constitute a quorum for business, but a lesser number
p.001281: may conduct hearings.
p.001281: (2) The Commission shall meet at the call of the Chairman or at the call of a majority of its members.
...

p.001281: time) during which they are engaged in the actual performance of duties vested in the Commission.
p.001281: (2) While away from their homes or regular places of business in the performance of services for the Commission,
p.001281: members of the Commission shall be allowed travel expenses, including per diem in lieu of subsistence, in the same
p.001281: manner as persons employed inter- mittently in the Government service are allowed expenses under section 5703
p.001281: of title 5 of the United States Code.
p.001281:
p.001281:
p.001281:
p.001281:
p.001281:
p.001281:
p.001281:
p.001281:
p.001281: January 30, 2020
p.001281: DUTIES OF THE COMMISSION
p.001281: SEC. 1802. ø300v–1¿ (a) STUDIES.—(1) The Commission shall undertake studies of the ethical and legal
p.001281: implications of—
p.001281: (A) the requirements for informed consent to participation in research projects and to otherwise undergo medical
p.001281: proce- dures;
p.001281: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001281:
p.001281:
p.001281:
p.001281:
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p.001281:
p.001281:
p.001281: C:\XML\SSA-MERGED.XML
p.001281:
p.001281: Sec. 1802 PUBLIC HEALTH SERVICE ACT 1282
p.001281:
p.001281: (B) the matter of defining death, including the advisability of developing a uniform definition of death;
p.001281: (C) voluntary testing, counseling, and information and education programs with respect to genetic diseases
p.001281: and condi- tions, taking into account the essential equality of all human beings, born and unborn;
p.001281: (D) the differences in the availability of health services as determined by the income or residence of the persons
p.001281: receiving the services;
p.001281: (E) current procedures and mechanisms designed (i) to safeguard the privacy of human subjects of behavioral and
p.001281: bio- medical research, (ii) to ensure the confidentiality of individ- ually identifiable patient records,
p.001281: and (iii) to ensure appro- priate access of patients to information continued 2 in such records, 3 and
p.001281: (F) such other matters relating to medicine or biomedical or behavioral research as the President may
p.001281: designate for study by the Commission.
p.001281: The Commission shall determine the priority and order of the stud- ies required under this paragraph.
p.001281: (2) The Commission may undertake an investigation or study of any other appropriate matter which relates
p.001281: to medicine or bio- medical or behavioral research (including the protection of human subjects of
p.001281: biomedical or behavioral research) and which is con- sistent with the purposes of this title on its own
p.001281: initiative or at the request of the head of the Federal agency.
p.001281: (3) In order to avoid duplication of effort, the Commission may, in lieu of, or as part of, any study or investigation
p.001281: required or oth- erwise conducted under this subsection, use a study or investiga- tion conducted by
p.001281: another entity if the Commission sets forth its reasons for such use.
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p.001285: di- rectly by the Secretary under this part,
p.001285: the Secretary shall reserve from amounts which would otherwise be allotted to such State under subsection (a)
p.001285: for the fiscal year the amount determined under paragraph (2).
p.001285: (2) The Secretary shall reserve for the purpose of paragraph (1) from amounts that would otherwise be allotted to such
p.001285: State under subsection (a) an amount equal to the amount which bears the same ratio to the State’s
p.001285: allotment for the fiscal year involved as the total amount provided or allotted for fiscal year 1981 by
p.001285: the Secretary to such tribe or tribal organization under the provisions of law referred to in subsection
p.001285: (a) bore to the total amount pro- vided or allotted for such fiscal year by the Secretary to the
p.001285: State and entities (including Indian tribes and tribal organizations) in the State under such provisions of
p.001285: law.
p.001285: (3) The amount reserved by the Secretary on the basis of a de- termination under this subsection shall be granted
p.001285: to the Indian tribe or tribal organization serving the individuals for whom such a determination has been
p.001285: made.
p.001285: (4) In order for an Indian tribe or tribal organization to be eli- gible for a grant for a fiscal year under this
p.001285: subsection, it shall sub- mit to the Secretary a plan for such fiscal year which meets such criteria as the
p.001285: Secretary may prescribe.
p.001285: (5) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such terms in section
p.001285: 4(b) and section 4(c) of the Indian Self-Determination and Education Assistance Act.
p.001285: (e) The Secretary shall conduct a study for the purpose of de- vising a formula for the equitable
p.001285: distribution of funds available for allotment to the States under this section. In conducting the study, the Secretary
p.001285: shall take into account—
p.001285: (1) the financial resources of the various States,
p.001285: (2) the populations of the States, and
p.001285: (3) any other factor which the Secretary may consider ap- propriate.
p.001285: Before June 30, 1982, the Secretary shall submit a report to the Congress respecting the development of
p.001285: a formula and make such recommendations as the Secretary may deem appropriate in order to ensure the most
p.001285: equitable distribution of funds under allotments under this section.
p.001285:
p.001285:
p.001285:
p.001285:
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p.001285:
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p.001285:
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p.001285:
p.001285:
p.001285: January 30, 2020
p.001285:
p.001285: PAYMENTS UNDER ALLOTMENTS TO STATES
p.001285: SEC. 1903. ø300w–2¿ (a)(1) For each fiscal year, the Secretary shall make payments, as provided by section 203
p.001285: of the Intergov- ernmental Cooperation Act of 1968 (42 U.S.C. 4213), to each State from its allotment under
p.001285: section 1902 (other than any amount re- served under section 1902(d)) from amounts appropriated for that
p.001285: fiscal year.
p.001285: (2) Any amount paid to a State for a fiscal year and remaining unobligated at the end of such year shall remain
p.001285: available for the next fiscal year to such State for the purposes for which it was made.
p.001285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
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p.001293: Comptroller General of the United States, or any of their duly authorized representatives, for
p.001293: examination, copying, or mechanical reproduction on or off the premises of the appropriate entity upon a
p.001293: reasonable request therefor.
p.001293: (d)(1) In conducting any investigation in a State, the Secretary or the Comptroller General of the United States
p.001293: may not make a request for any information not readily available to such State or an entity which has
p.001293: received funds from an allotment made to the State under this part or make an unreasonable request for infor-
p.001293: mation to be compiled, collected, or transmitted in any form not readily available.
p.001293: (2) Paragraph (1) does not apply to the collection, compilation, or transmittal of data in the course of a judicial
p.001293: proceeding.
p.001293:
p.001293:
p.001293:
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p.001293:
p.001293:
p.001293: January 30, 2020
p.001293: NONDISCRIMINATION
p.001293: SEC. 1908. ø300w–7¿ (a)(1) For the purpose of applying the prohibitions against discrimination on the
p.001293: basis of age under the Age Discrimination Act of 1975, on the basis of handicap under sec- tion 504 of the
p.001293: Rehabilitation Act of 1973, on the basis of sex under title IX of the Education Amendments of 1972, or on the
p.001293: basis of race, color, or national origin under title VI of the Civil Rights Act of 1964, programs and activities
p.001293: funded in whole or in part with funds made available under this part are considered to be pro- grams
p.001293: and activities receiving Federal financial assistance.
p.001293: (2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits
p.001293: of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds
p.001293: made available under this part.
p.001293: (b) Whenever the Secretary finds that a State, or an entity that has received a payment from an
p.001293: allotment to a State under section 1902, has failed to comply with a provision of law referred to in subsection
p.001293: (a)(1), with subsection (a)(2), or with an applicable regulation (including one prescribed to carry out subsection
p.001293: (a)(2)), the Secretary shall notify the chief executive officer of the State and shall request him to secure
p.001293: compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer
p.001293: fails or refuses to secure compliance, the Secretary may—
p.001293: (1) refer the matter to the Attorney General with a rec- ommendation that an appropriate civil action be
p.001293: instituted,
p.001293: (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964, the Age
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p.001297:
p.001297:
p.001297:
p.001297:
p.001297:
p.001297:
p.001297:
p.001297:
p.001297:
p.001297: January 30, 2020
p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
p.001297: including activities that enhance communication among individuals, families, caregivers, and treatment providers; and
p.001297: (vii) as appropriate to, and reflective of, the uses the State proposes for the block grant funds, include—
p.001297: (I) a description of the activities intended to reduce hospitalizations and hospital stays using the block
p.001297: grant funds;
p.001297: (II) a description of the activities intended to reduce incidents of suicide using the block grant funds;
p.001297: (III) a description of how the State integrates mental health and primary care using the block grant funds,
p.001297: which may include providing, in the case of individuals with co-occurring mental and substance use
p.001297: disorders, both mental and sub- stance use disorders services in primary care set-
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p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
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p.001301: which preserves human dignity and assures continuity and high qual- ity care.
p.001301: SEC. 1914. ø300x–3¿ STATE MENTAL HEALTH PLANNING COUNCIL.
p.001301: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will
p.001301: establish and maintain a State mental health planning council in accordance with the condi- tions described in this
p.001301: section.
p.001301: (b) DUTIES.—A condition under subsection (a) for a Council is that the duties of the Council are—
p.001301: (1) to review plans provided to the Council pursuant to section 1915(a) by the State involved and to
p.001301: submit to the State any recommendations of the Council for modifications to the plans;
p.001301: (2) to serve as an advocate for adults with a serious men- tal illness, children with a severe emotional
p.001301: disturbance, and other individuals with mental illnesses or emotional problems; and
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
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p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301: January 30, 2020
p.001301: (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of
p.001301: mental health serv- ices within the State.
p.001301: (c) MEMBERSHIP.—
p.001301: (1) IN GENERAL.—A condition under subsection (a) for a Council is that the Council be composed of
p.001301: residents of the State, including representatives of—
p.001301: (A) the principal State agencies with respect to—
p.001301: (i) mental health, education, vocational rehabilita- tion, criminal justice, housing, and social services; and
p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
p.001301: (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional
p.001301: dis- turbance to other members of the Council is sufficient to
p.001301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001301:
p.001301:
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p.001301: Sec. 1915 PUBLIC HEALTH SERVICE ACT 1302
p.001301:
p.001301: provide adequate representation of such children in the de- liberations of the Council; and
...

p.001325: State that funds under this subpart be provided directly by the Sec- retary to such tribe or organization;
p.001325: and
p.001325: (B) makes a determination that the members of such tribe or tribal organization would be better served
p.001325: by means of grants made directly by the Secretary under this; 11
p.001325: the Secretary shall reserve from the allotment under section 1921 for the State for the fiscal year involved an
p.001325: amount that bears the same ratio to the allotment as the amount provided under this subpart to the tribe or
p.001325: tribal organization for fiscal year 1991 for activities relating to the prevention and treat- ment of the
p.001325: abuse of alcohol and other drugs bore to the amount of the portion of the allotment under this subpart
p.001325: for the State for such fiscal year that was expended for such ac- tivities.
p.001325: (2) TRIBE OR TRIBAL ORGANIZATION AS GRANTEE.—The amount reserved by the Secretary on the basis of a
p.001325: determina- tion under this paragraph 12 shall be granted to the Indian tribe or tribal organization
p.001325: serving the individuals for whom such a determination has been made.
p.001325: (3) APPLICATION.—In order for an Indian tribe or tribal or- ganization to be eligible for a grant for a fiscal year
p.001325: under this paragraph, it shall submit to the Secretary a plan for such fis- cal year that meets such criteria as
p.001325: the Secretary may pre- scribe.
p.001325: (4) DEFINITION.—The terms ‘‘Indian tribe’’ and ‘‘tribal orga- nization’’ have the same meaning given such terms
p.001325: in sub- sections (b) and (c) of section 4 of the Indian Self-Determina- tion and Education Assistance Act.
p.001325: SEC. 1934. ø300x–34¿ DEFINITIONS.
p.001325: For purposes of this subpart:
p.001325: (1) The term ‘‘authorized activities’’, subject to section 1931, means the activities described in
p.001325: section 1921(b).
p.001325: (2) The term ‘‘funding agreement’’, with respect to a grant under section 1921 to a State, means that the
p.001325: Secretary may make such a grant only if the State makes the agreement in- volved.
p.001325: (3) The term ‘‘prevention activities’’, subject to section 1931, means activities to prevent substance
p.001325: use disorders.
p.001325: (4) The term ‘‘substance abuse’’ means the abuse of alcohol or other drugs.
p.001325:
p.001325:
p.001325:
p.001325:
p.001325:
p.001325: January 30, 2020
p.001325: 11 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘under this subpart’’.
p.001325: 12 So in law. See section 102 of Public Law 102–321 (106 Stat. 402). Probably should be ‘‘sub- section’’.
p.001325: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001325:
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p.001325:
p.001325:
p.001327: 1327
p.001327: PUBLIC HEALTH SERVICE ACT
p.001327: Sec. 1941
p.001327:
p.001327: (5) The term ‘‘treatment activities’’ means treatment serv- ices and, subject to section 1931, authorized activities
p.001327: that are related to treatment services.
...

p.001331: (1) CERTAIN FALSE STATEMENTS AND REPRESENTATIONS.—A person shall not knowingly and willfully make or cause
p.001331: to be made any false statement or representation of a material fact in connection with the furnishing of
p.001331: items or services for which payments may be made by a State from a grant made to the State under section
p.001331: 1911 or 1921.
p.001331: (2) CONCEALING OR FAILING TO DISCLOSE CERTAIN EVENTS.—A person with knowledge of the
p.001331: occurrence of any event affecting the initial or continued right of the person to receive any payments from
p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
p.001331: (1) RULE OF CONSTRUCTION REGARDING CERTAIN CIVIL RIGHTS LAWS.—For the purpose of applying the
p.001331: prohibitions against discrimination on the basis of age under the Age Dis- crimination Act of 1975, on the
p.001331: basis of handicap under section 504 of the Rehabilitation Act of 1973, on the basis of sex under title IX of the
p.001331: Education Amendments of 1972, or on the basis of race, color, or national origin under title VI of the Civil
p.001331: Rights Act of 1964, programs and activities funded in whole or in part with funds made available under section 1911 or
p.001331: 1921 shall be considered to be programs and activities receiving Fed- eral financial assistance.
p.001331: (2) PROHIBITION.—No person shall on the ground of sex (including, in the case of a woman, on the
p.001331: ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be
p.001331: denied the benefits of, or be subjected to discrimination under, any program or activity funded in
p.001331: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001331:
p.001331:
p.001331:
p.001331:
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p.001331:
p.001331: Sec. 1948 PUBLIC HEALTH SERVICE ACT 1332
p.001331:
p.001331: whole or in part with funds made available under section 1911 or 1921.
p.001331: (b) ENFORCEMENT.—
p.001331: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
p.001331: State and shall request the chief executive officer to secure compliance. If within a reasonable period of
p.001331: time, not to exceed
p.001331: 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
p.001331: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.001331: insti- tuted;
p.001331: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.001331: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.001331: Rights Act of 1964, as may be applicable; or
p.001331: (C) take such other actions as may be authorized by
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
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p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331:
p.001331: January 30, 2020
p.001331: law.
p.001331: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.001331: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.001331: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.001331: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.001331: the United States for such relief as may be appropriate, including injunc- tive relief.
p.001331: SEC. 1948. ø300x–58¿ TECHNICAL ASSISTANCE AND PROVISION OF SUP- PLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001331: (a) TECHNICAL ASSISTANCE.—The Secretary shall, without charge to a State receiving a grant under section 1911
p.001331: or 1921, pro- vide to the State (or to any public or nonprofit private entity within the State) technical assistance
p.001331: with respect to the planning, devel- opment, and operation of any program or service carried out pursu- ant to the
p.001331: program involved. The Secretary may provide such tech- nical assistance directly, through contract, or through grants.
p.001331: (b) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
...

p.001333: and accountability based on outcome and other performance measures. The plans shall each include—
p.001333: (1) a description of the flexibility that would be given to the States under the plan;
p.001333: (2) the common set of performance measures that would be used for accountability, including measures that would be used
p.001333: for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a
p.001333: co-occurring sub- stance abuse and mental disorders, and for programs under subpart I for children with
p.001333: serious emotional disturbance and adults with serious mental illness and for individuals with co- occurring mental
p.001333: health and substance abuse disorders;
p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
...

p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
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p.001343:
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p.001343:
p.001343:
p.001343: January 30, 2020
p.001343:
p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
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p.001343:
p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
...

p.001353:
p.001353: departments and agencies of the Federal Government who ad- minister programs that provide such services, and
p.001353: encourage such other departments and agencies to make recommenda- tions, as appropriate, for legislation to
p.001353: modify such programs in order to facilitate the use of all Government programs which provide such services as a
p.001353: basis for delivery of more com- prehensive prevention services and more comprehensive pro- grams of care for
p.001353: pregnant adolescents and adolescent parents;
p.001353: (4) give priority in the provision of funds, where appro- priate, to applicants using single or coordinated
p.001353: grant applica- tions for multiple programs; and
p.001353: (5) give priority, where appropriate, to the provision of funds under Federal programs administered by
p.001353: the Secretary (other than the program established by this title) to projects providing comprehensive
p.001353: prevention services and comprehen- sive programs of care for pregnant adolescents and adolescent parents.
p.001353: (b) Any recipient of a grant for a demonstration project for services under this title shall coordinate
p.001353: its activities with any other recipient of such a grant which is located in the same local- ity.
p.001353: RESEARCH
p.001353: SEC. 2008. ø300z–7¿ (a)(1) The Secretary may make grants and enter into contracts with public agencies
p.001353: or private organiza- tions or institutions of higher education to support the research and dissemination
p.001353: activities described in paragraphs (4), (5), and
p.001353: (6) of section 2001(b).
p.001353: (2) The Secretary may make grants or enter into contracts under this section for a period of one year.
p.001353: A grant or contract under this section for a project may be renewed for four additional one-year periods, which
p.001353: need not be consecutive.
p.001353: (3) A grant or contract for any one-year period under this sec- tion may not exceed $100,000 for the direct costs of
p.001353: conducting re- search or disemination 1 activities under this section and may in- clude such additional
p.001353: amounts for the indirect costs of conducting such activities as the Secretary determines appropriate. The
p.001353: Sec- retary may waive the preceding sentence with respect to a specific project if he determines that—
p.001353: (A) exceptional circumstances warrant such waiver and that the project will have national impact; or
p.001353: (B) additional amounts are necessary for the direct costs of conducting limited demonstration projects for the
p.001353: provision of necessary services in order to provide data for research carried out under this title.
p.001353: (4) The amount of any grant or contract made under this sec- tion may remain available for obligation
p.001353: or expenditure after the close of the one-year period for which such grant or contract is made in order
p.001353: to assist the recipient in preparing the report re- quired by subsection (f)(1).
p.001353: (b)(1) Funds provided for research under this section may be used for descriptive or explanatory surveys,
p.001353: longitudinal studies, or
p.001353:
p.001353:
p.001353:
p.001353: January 30, 2020
p.001353: 1 So in law. Probably should be ‘‘dissemination’’.
...

p.001371: aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
p.001371: (3) VACCINES RECOMMENDED FOR USE IN PREGNANT WOMEN.—The Secretary shall revise the Vaccine
p.001371: Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines
p.001371: recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and
p.001371: the information described in subpara- graphs (B) and (C) of paragraph (2) with respect to such vac- cines.
p.001371: COMPENSATION
p.001371: SEC. 2115. ø300aa–15¿ (a) GENERAL RULE.—Compensation awarded under the Program to a petitioner under section
p.001371: 2111 for a vaccine-related injury or death associated with the administra- tion of a vaccine after the
p.001371: effective date of this part 8 shall include the following:
p.001371: (1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and
p.001371: reasonable projected unreimbursable expenses which—
p.001371: (i) result from the vaccine-related injury for which the petitioner seeks compensation,
p.001371: (ii) have been or will be incurred by or on behalf of the person who suffered such injury, and
p.001371: (iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be
p.001371: reasonably nec- essary, or
p.001371: (II) have been or will be for rehabilitation, develop- mental evaluation, special education, vocational
p.001371: training and placement, case management services, counseling, emotional or behavioral therapy,
p.001371: residential and custodial care and service expenses, special equipment, related trav- el expenses, and facilities
p.001371: determined to be reasonably nec- essary.
p.001371:
p.001371:
p.001371:
p.001371: January 30, 2020
p.001371: 8 Effective October 1, 1988.
p.001371:
p.001371: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001371:
p.001371:
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p.001371:
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p.001373: 1373
p.001373: PUBLIC HEALTH SERVICE ACT
p.001373: Sec. 2115
p.001373:
p.001373: (B) Subject to section 2116(a)(2), actual unreimbursable ex- penses incurred before the date of the judgment awarding
p.001373: such expenses which—
p.001373: (i) resulted from the vaccine-related injury for which the petitioner seeks compensation,
p.001373: (ii) were incurred by or on behalf of the person who suffered such injury, and
p.001373: (iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special
p.001373: edu- cation, vocational training and placement, case manage- ment services, counseling, emotional or behavioral
p.001373: therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and
p.001373: facilities deter- mined to be reasonably necessary.
p.001373: (2) In the event of a vaccine-related death, an award of
p.001373: $250,000 for the estate of the deceased.
...

p.001373: a vaccine before the effective date of this part 9 may include the compensation described in paragraphs (1)(A)
p.001373: and (2) of subsection (a) and may also include an amount, not to exceed a combined total of $30,000, for—
p.001373: (1) lost earnings (as provided in paragraph (3) of sub- section (a)),
p.001373: (2) pain and suffering (as provided in paragraph (4) of subsection (a)), and
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 9 Effective October 1, 1988.
p.001373:
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
p.001373:
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p.001373: Sec. 2115 PUBLIC HEALTH SERVICE ACT 1374
p.001373:
p.001373: (3) reasonable attorneys’ fees and costs (as provided in subsection (e) 10.
p.001373: (c) RESIDENTIAL AND CUSTODIAL CARE AND SERVICE.—The amount of any compensation for residential and
p.001373: custodial care and service expenses under subsection (a)(1) shall be sufficient to en- able the compensated
p.001373: person to remain living at home.
p.001373: (d) TYPES OF COMPENSATION PROHIBITED.—Compensation awarded under the Program may not include the
p.001373: following:
p.001373: (1) Punitive or exemplary damages.
p.001373: (2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation
p.001373: for other than the health, education, or welfare of the person who suf- fered the vaccine-related injury with
p.001373: respect to which the com- pensation is paid.
p.001373: (e) ATTORNEYS’ FEES.—
p.001373: (1) In awarding compensation on a petition filed under sec- tion 2111 the special master or court shall also award as
p.001373: part of such compensation an amount to cover—
p.001373: (A) reasonable attorneys’ fees, and
p.001373: (B) other costs,
p.001373: incurred in any proceeding on such petition. If the judgment of a special master or court on such a petition
p.001373: does not award compensation, the special master or court may award an amount of compensation to
p.001373: cover petitioner’s reasonable attor- neys’ fees and other costs incurred in any proceeding on such
p.001373: petition if the special master or court determines that the peti- tion was brought in good faith and there was
p.001373: a reasonable basis for the claim for which the petition was brought.
p.001373: (2) If the petitioner, before the effective date of this part, 11 filed a civil action for damages for any
p.001373: vaccine-related injury or death for which compensation may be awarded under the Program, and petitioned under
p.001373: section 2111(a)(5) to have such action dismissed and to file a petition for compensation under the Program,
p.001373: in awarding compensation on such petition the special master or court may include an amount of compensa-
p.001373: tion limited to the costs and expenses incurred by the peti- tioner and the attorney of the petitioner
p.001373: before the effective date of this part 11 in preparing, filing, and prosecuting such civil action
...

p.001405: (d) EVALUATION AND REPORTS.—
p.001405: (1) The Secretary may not make a grant under subsection
p.001405: (a) unless the applicant for the grant agrees, with respect to the project carried out pursuant to subsection
p.001405: (a), to submit to the Secretary—
p.001405: (A) information sufficient to assist in the replication of the model protocol developed pursuant to the project;
p.001405: and
p.001405: (B) such reports as the Secretary may require.
p.001405: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001405:
p.001405:
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p.001405:
p.001407: 1407
p.001407: PUBLIC HEALTH SERVICE ACT
p.001407: Sec. 2320
p.001407:
p.001407: (2) The Secretary shall provide for evaluations of projects carried out pursuant to subsection (a) and shall
p.001407: annually sub- mit to the Congress a report describing such projects. The re- port shall include the findings
p.001407: made as a result of such evalua- tions and may include any recommendations of the Secretary for appropriate
p.001407: administrative and legislative initiatives with respect to the program established in this section.
p.001407: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001407: to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991, and such
p.001407: sums as may be necessary for each of the fiscal years 1994 through 1996.
p.001407: SEC. 2319. ø300cc–19¿ NATIONAL BLOOD RESOURCE EDUCATION PRO- GRAM.
p.001407: After consultation with the Director of the National Heart, Lung, and Blood Institute and the
p.001407: Commissioner of Food and Drugs, the Secretary shall establish a program of research and education
p.001407: regarding blood donations and transfusions to maintain and improve the safety of the blood supply.
p.001407: Education programs shall be directed at health professionals, patients, and the commu- nity to—
p.001407: (1) in the case of the public and patients undergoing treat- ment—
p.001407:
p.001407:
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p.001407:
p.001407:
p.001407:
p.001407: January 30, 2020
p.001407: (A) increase awareness that the process of donating blood is safe;
p.001407: (B) promote the concept that blood donors are contrib- utors to a national need to maintain an adequate and safe blood
p.001407: supply;
p.001407: (C) encourage blood donors to donate more than once a year; and
p.001407: (D) encourage repeat blood donors to recruit new do- nors;
p.001407: (2) in the case of health professionals—
p.001407: (A) improve knowledge, attitudes, and skills of health professionals in the appropriate use of blood and
p.001407: blood components;
p.001407: (B) increase the awareness and understanding of health professionals regarding the risks versus
p.001407: benefits of blood transfusion; and
p.001407: (C) encourage health professionals to consider alter- natives to the administration of blood or blood components
p.001407: for their patients; and
p.001407: (3) in the case of the community, increase coordination, communication, and collaboration among community,
p.001407: profes- sional, industry, and government organizations regarding blood donation and transfusion issues.
p.001407: SEC. 2320. ø300cc–20¿ ADDITIONAL AUTHORITY WITH RESPECT TO RE- SEARCH.
p.001407: (a) DATA COLLECTION WITH RESPECT TO NATIONAL PREVA-
...

p.001407:
p.001407:
p.001407:
p.001407: January 30, 2020
p.001407: 4 So in law. Probably should be ‘‘agreements’’.
p.001407: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001407:
p.001407:
p.001407:
p.001407:
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p.001407:
p.001409: 1409
p.001409: PUBLIC HEALTH SERVICE ACT
p.001409: Sec. 2341
p.001409:
p.001409: (d) SOCIAL SCIENCES RESEARCH.—The Secretary, acting through the Director of the National Institute
p.001409: of Mental Health, may make grants to public and nonprofit private entities for the purpose of assisting
p.001409: grantees in conducting scientific research into the psychological and social sciences as such sciences relate
p.001409: to ac- quired immune deficiency syndrome.
p.001409: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.001409: (1) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be
p.001409: necessary for each fiscal year.
p.001409: (2) Amounts appropriated pursuant to paragraph (1) to carry out subsection (c) shall remain available until
p.001409: expended.
p.001409: PART C—RESEARCH TRAINING
p.001409: SEC. 2341. ø300cc–31¿ FELLOWSHIPS AND TRAINING.
p.001409: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control 5, shall establish
p.001409: fellowship and training programs to be conducted by the Centers for Disease Con- trol 5 to train individuals to
p.001409: develop skills in epidemiology, surveil- lance, testing, counseling, education, information, and laboratory
p.001409: analysis relating to acquired immune deficiency syndrome. Such programs shall be designed to enable health
p.001409: professionals and health personnel trained under such programs to work, after re- ceiving such training,
p.001409: in national and international efforts toward the prevention, diagnosis, and treatment of acquired immune defi-
p.001409: ciency syndrome.
p.001409: (b) PROGRAMS CONDUCTED BY NATIONAL INSTITUTE OF MENTAL
p.001409: HEALTH.—The Secretary, acting through the Director of the Na- tional Institute of Mental Health, shall
p.001409: conduct or support fellow- ship and training programs for individuals pursuing graduate or postgraduate
p.001409: study in order to train such individuals to conduct scientific research into the psychological and social
p.001409: sciences as such sciences relate to acquired immune deficiency syndrome.
p.001409: (c) RELATIONSHIP TO LIMITATION ON NUMBER OF EMPLOYEES.— Any individual receiving a fellowship or receiving
p.001409: training under subsection (a) or (b) shall not be included in any determination of the number of full-time
p.001409: equivalent employees of the Department of Health and Human Services for the purpose of any limitation on the
p.001409: number of such employees established by law prior to, on, or after the date of the enactment of the AIDS
p.001409: Amendments of 1988.
p.001409: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001409: to be appropriated such sums as may be necessary for each fiscal year.
p.001409:
p.001409:
p.001409:
p.001409:
...

p.001415:
p.001415:
p.001415:
p.001415:
p.001415:
p.001415:
p.001415:
p.001415:
p.001415: January 30, 2020
p.001415: Subpart II—Emergency Discretionary Fund
p.001415: SEC. 2356. ø300cc–43¿ EMERGENCY DISCRETIONARY FUND.
p.001415: (a) IN GENERAL.—
p.001415: (1) ESTABLISHMENT.—There is established a fund con- sisting of such amounts as may be appropriated
p.001415: under sub- section (g). Subject to the provisions of this section, the Direc- tor of the Office, after
p.001415: consultation with the advisory council established under section 2352, may expend amounts in the Fund for
p.001415: the purpose of conducting and supporting such AIDS activities, including projects of AIDS research, as may be
p.001415: au- thorized in this Act for the National Institutes of Health.
p.001415: (2) PRECONDITIONS TO USE OF FUND.—Amounts in the Fund may be expended only if—
p.001415: (A) the Director identifies the particular set of AIDS activities for which such amounts are to be expended;
p.001415: (B) the set of activities so identified constitutes either a new project or additional AIDS activities for an existing
p.001415: project;
p.001415: (C) the Director of the Office has made a determina- tion that there is a significant need for such
p.001415: set of activi- ties; and
p.001415: (D) as of June 30 of the fiscal year preceding the fiscal year in which the determination is made, such need
p.001415: was not provided for in any appropriations Act passed by the House of Representatives to make
p.001415: appropriations for the Departments of Labor, Health and Human Services (in- cluding the National Institutes of
p.001415: Health), Education, and related agencies for the fiscal year in which the determina- tion is made.
p.001415: (3) TWO-YEAR USE OF FUND FOR PROJECT INVOLVED.—In the case of an identified set of AIDS
p.001415: activities, obligations of amounts in the Fund may not be made for such set of activities after the expiration of the
p.001415: 2-year period beginning on the date on which the initial obligation of such amounts is made for such set.
p.001415: (b) PEER REVIEW.—With respect to an identified set of AIDS activities carried out with amounts in the
p.001415: Fund, this section may not be construed as waiving applicable requirements for peer re- view.
p.001415: (c) LIMITATIONS ON USE OF FUND.—
p.001415: (1) CONSTRUCTION OF FACILITIES.—Amounts in the Fund may not be used for the construction, renovation, or
p.001415: relocation of facilities, or for the acquisition of land.
p.001415: (2) CONGRESSIONAL DISAPPROVAL OF PROJECTS.—
p.001415: (A) Amounts in the Fund may not be expended for the fiscal year involved for an identified set of AIDS activities, or a
p.001415: category of AIDS activities, for which—
p.001415: (i)(I) amounts were made available in an appro- priations Act for the preceding fiscal year; and
p.001415: (II) amounts are not made available in any appro- priations Act for the fiscal year involved; or
p.001415: (ii) amounts are by law prohibited from being ex- pended.
p.001415: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001415:
p.001415:
p.001415:
p.001415:
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p.001415:
p.001415: Sec. 2359 PUBLIC HEALTH SERVICE ACT 1416
p.001415:
...

p.001425: Health and Human Services.
p.001425: (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments
p.001425: under sec- tion 2401(a) to the State by an amount equal to the costs of
p.001425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001425:
p.001425:
p.001425:
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p.001425:
p.001425: Sec. 2412 PUBLIC HEALTH SERVICE ACT 1426
p.001425:
p.001425: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001425: Secretary. The Sec- retary shall, for the payment of expenses incurred in complying with such request, expend the
p.001425: amounts withheld.
p.001425: SEC. 2412. ø300dd–11¿ REPORT BY SECRETARY.
p.001425: Not later than March 1, 1990, the Secretary shall report to the Congress on the activities of the States under
p.001425: this part. Such re- port shall include a recommendation as to whether or not the pro- gram under this part
p.001425: should be extended beyond fiscal year 1990 and may include any recommendations of the Secretary for
p.001425: appro- priate administrative and legislative initiatives.
p.001425: SEC. 2413. ø300dd–12¿ DEFINITIONS.
p.001425: For purposes of this part:
p.001425: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such terms in sections
p.001425: 4(b) and 4(c) of the Indian Self-Determination and Education Assistance Act.
p.001425:
p.001425:
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p.001425:
p.001425:
p.001425: January 30, 2020
p.001425: (2) The term ‘‘infected with the etiologic agent for acquired immune deficiency syndrome’’ includes any condition
p.001425: arising from infection with such etiologic agent.
p.001425: (3)(A) An individual is considered to have low income if the individual’s income does not exceed 200 percent of
p.001425: the official poverty line.
p.001425: (B) The term ‘‘official poverty line’’ refers, with respect to an individual, to the official poverty
p.001425: line defined by the Office of Management and Budget, and revised annually in accord- ance with section
p.001425: 673(2) of the Omnibus Budget Reconciliation Act of 1981, applicable to a family of the size involved.
p.001425: (4)(A) The term ‘‘State’’ means, except as provided in sub- paragraph (B), each of the several States, the
p.001425: District of Co- lumbia, the Commonwealth of Puerto Rico, and each territory of the United States.
p.001425: (B) For purposes of subsections (b) and (d) of section 2408, the term ‘‘State’’ means each of the several States, the
p.001425: District of Columbia, and the Commonwealth of Puerto Rico.
p.001425: (5) The term ‘‘territory of the United States’’ means each of the following: the Virgin Islands, Guam,
...

p.001427: (2) The term ‘‘subacute care’’ means medical and health care services that are required for individuals
p.001427: recovering from acute care episodes that are less intensive than the level of care provided in
p.001427: acute-care hospitals, and includes skilled nursing care, hospice care, and other types of health
p.001427: services provided in other long-term-care facilities.
p.001427: (b) The Secretary shall conduct three demonstration projects to determine the effectiveness and cost of providing the
p.001427: subacute-care services described in subsection (b) to individuals infected with the etiologic agent for acquired
p.001427: immune deficiency syndrome, and the impact of such services on the health status of such individuals.
p.001427: (c)(1) The services provided under each demonstration project shall be designed to meet the specific needs of
p.001427: individuals infected with the etiologic agent for acquired immune deficiency syndrome, and shall include—
p.001427: (A) the care and treatment of such individuals by pro- viding—
p.001427: (i) subacute care;
p.001427: (ii) emergency medical care and specialized diagnostic and therapeutic services as needed and where appropriate,
p.001427: either directly or through affiliation with a hospital that has experience in treating individuals with
p.001427: acquired im- mune deficiency syndrome; and
p.001427: (iii) case management services to ensure, through ex- isting services and programs whenever possible,
p.001427: appro- priate discharge planning for such individuals; and
p.001427: (B) technical assistance, to other facilities in the region served by such facility, that is directed
p.001427: toward education and training of physicians, nurses, and other health-care profes- sionals in the subacute
p.001427: care and treatment of individuals in- fected with the etiologic agent for acquired immune deficiency
p.001427: syndrome.
p.001427: (2) Services provided under each demonstration project may also include—
p.001427: (A) hospice services;
p.001427: (B) outpatient care; and
p.001427: (C) outreach activities in the surrounding community to hospitals and other health-care facilities that serve
p.001427: individuals infected with the etiologic agent for acquired immune defi- ciency syndrome.
p.001427: (d) The demonstration projects shall be conducted—
p.001427:
p.001427: January 30, 2020 As Amended Through P.L. 116-94,
p.001427: Enacted December 20, 2019
p.001427:
p.001427:
p.001427:
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p.001427:
p.001427: Sec. 2421 PUBLIC HEALTH SERVICE ACT 1428
p.001427:
p.001427: (1) during a 4-year period beginning not later than 9 months after the date of enactment of this section; 3
p.001427: and
p.001427: (2) at sites that—
p.001427: (A) are geographically diverse and located in areas that are appropriate for the provision of the
p.001427: required and authorized services; and
p.001427: (B) have the highest incidence of cases of acquired im- mune deficiency syndrome and the greatest need
p.001427: for subacute-care services.
p.001427: (e) The Secretary shall evaluate the operations of the dem- onstration projects and shall submit to the
...

p.001429: recent scientific data relating to such syndrome), including—
p.001429: (1) measures for the prevention of exposure to, and the transmission of, the etiologic agent for such
p.001429: syndrome;
p.001429: (2) the accuracy and reliability of the results of such test-
p.001429: ing;
p.001429: (3) the significance of the results of such testing, including
p.001429:
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p.001429:
p.001429:
p.001429:
p.001429: January 30, 2020
p.001429: the potential for developing acquired immune deficiency syn- drome; and
p.001429: (4) encouraging individuals, as appropriate, to undergo testing for such etiologic agent and providing
p.001429: information on the benefits of such testing.
p.001429: (b) COUNSELING OF INDIVIDUALS WITH NEGATIVE TEST RE- SULTS.—The Secretary may not make a grant
p.001429: under section 2431 to a State unless the State agrees that, if the results of testing con- ducted pursuant to such
p.001429: section indicate that an individual is not infected with the etiologic agent for acquired immune
p.001429: deficiency syndrome, the State will review for the individual the information provided pursuant to subsection
p.001429: (a) with respect to such syndrome, including—
p.001429: (1) the information described in paragraphs (1) through (3) of such subsection; and
p.001429: (2) the appropriateness of further counseling, testing, and education of the individual with respect to
p.001429: acquired immune deficiency syndrome.
p.001429: (c) COUNSELING OF INDIVIDUALS WITH POSITIVE TEST RE- SULTS.—The Secretary may not make a
p.001429: grant under section 2431 to a State unless the State agrees that, if the results of testing con- ducted pursuant
p.001429: to such section indicate that an individual is in- fected with the etiologic agent for acquired immune
p.001429: deficiency syn- drome, the State will provide to the individual appropriate coun- seling with respect to such
p.001429: syndrome, including—
p.001429: (1) reviewing the information described in paragraphs (1) through (3) of subsection (a);
p.001429: (2) reviewing the appropriateness of further counseling, testing, and education of the individual with
p.001429: respect to ac- quired immune deficiency syndrome;
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001429:
p.001429:
p.001429:
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p.001429: Sec. 2433 PUBLIC HEALTH SERVICE ACT 1430
p.001429:
p.001429: (3) the importance of not exposing others to the etiologic agent for acquired immune deficiency syndrome;
p.001429: (4) the availability in the geographic area of any appro- priate services with respect to health care,
p.001429: including mental health care and social and support services;
p.001429: (5) the benefits of locating and counseling any individual by whom the infected individual may have been
p.001429: exposed to the etiologic agent for acquired immune deficiency syndrome and any individual whom the infected
p.001429: individual may have exposed to such etiologic agent; and
p.001429: (6) the availability, if any, of the services of public health authorities with respect to locating and
p.001429: counseling any indi- vidual described in paragraph (5).
p.001429: (d) RULE OF CONSTRUCTION WITH RESPECT TO COUNSELING WITHOUT TESTING.—Agreements entered into
p.001429: pursuant to sub- sections (a) through (c) may not be construed to prohibit any grant- ee under section 2431 from
p.001429: expending the grant for the purpose of providing counseling services described in such subsections to an
p.001429: individual who will not undergo testing described in such section as a result of the grantee or the
...

p.001429: drug abuse.
p.001429: (4) Paragraph (3) may not be construed to prohibit a coun- selor who has already performed the counseling of an
p.001429: indi- vidual required by paragraph (2), to provide accurate informa- tion about means to reduce an individual’s risk
p.001429: of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
p.001429: informational materials used are not obscene.
p.001429: SEC. 2433. ø300dd–33¿ FUNDING.
p.001429: For the purpose of grants under section 2431, there are author- ized to be appropriated $100,000,000 for each of
p.001429: the fiscal years 1989 and 1990.
p.001429:
p.001429:
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p.001429:
p.001429:
p.001429: January 30, 2020
p.001429: 4 Probably should be ‘‘part’’. See section 118(b)(1)(B) of Public Law 102–321 (106 Stat. 348).
p.001429: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001429:
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p.001429:
p.001429:
p.001431: 1431
p.001431: PUBLIC HEALTH SERVICE ACT
p.001431: Sec. 2502
p.001431:
p.001431: TITLE XXV—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001431: SEC. 2500. ø300ee¿ USE OF FUNDS.
p.001431: (a) IN GENERAL.—The purpose of this title is to provide for the establishment of education and information
p.001431: programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune
p.001431: deficiency syndrome.
p.001431: (b) CONTENTS OF PROGRAMS.—All programs of education and information receiving funds under this title shall
p.001431: include informa- tion about the harmful effects of promiscuous sexual activity and intravenous substance
p.001431: abuse, and the benefits of abstaining from such activities.
p.001431: (c) LIMITATION.—None of the funds appropriated to carry out this title may be used to provide education or
p.001431: information designed to promote or encourage, directly, homosexual or heterosexual sex- ual activity or intravenous
p.001431: substance abuse.
p.001431: (d) CONSTRUCTION.—Subsection (c) may not be construed to re- strict the ability of an education program that
p.001431: includes the infor- mation required in subsection (b) to provide accurate information about various means
p.001431: to reduce an individual’s risk of exposure to, or the transmission of, the etiologic agent for acquired immune
p.001431: de- ficiency syndrome, provided that any informational materials used are not obscene.
p.001431: PART A—FORMULA GRANTS TO STATES
p.001431: SEC. 2501. ø300ee–11¿ ESTABLISHMENT OF PROGRAM.
p.001431: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001431: fiscal years 1989 through 1991 make an allotment for each State in an amount de- termined in accordance
p.001431: with section 2507. The Secretary shall make payments each such fiscal year to each State from the allot- ment for
p.001431: the State if the Secretary approves for the fiscal year in- volved an application submitted by the State
p.001431: pursuant to section 2503.
p.001431: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001431: unless the State in- volved agrees to expend the payments only for the purpose of car- rying out, in
p.001431: accordance with section 2502, public information ac- tivities with respect to acquired immune deficiency
p.001431: syndrome.
p.001431: SEC. 2502. ø300ee–12¿ PROVISIONS WITH RESPECT TO CARRYING OUT PURPOSE OF GRANTS.
p.001431: A State may expend payments received under section 2501(a)—
p.001431: (1) to develop, establish, and conduct public information activities relating to the prevention and
p.001431: diagnosis of acquired immune deficiency syndrome for those populations or commu- nities in the State in
p.001431: which there are a significant number of individuals at risk of infection with the etiologic agent for such
p.001431: syndrome;
p.001431:
p.001431:
p.001431:
p.001431: January 30, 2020
p.001431: 1 See footnote at beginning of title XXIII.
p.001431:
p.001431: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001431:
p.001431:
p.001431:
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p.001431: Sec. 2503 PUBLIC HEALTH SERVICE ACT 1432
p.001431:
p.001431: (2) to develop, establish, and conduct such public informa- tion activities for the general public relating to the
p.001431: prevention and diagnosis of such syndrome;
p.001431: (3) to develop, establish, and conduct activities to reduce risks relating to such syndrome, including
p.001431: research into the prevention of such syndrome;
p.001431: (4) to conduct demonstration projects for the prevention of such syndrome;
p.001431: (5) to provide technical assistance to public entities, to nonprofit private entities concerned with such
p.001431: syndrome, to schools, and to employers, for the purpose of developing infor- mation programs relating to such
p.001431: syndrome;
p.001431: (6) with respect to education and training programs for the prevention of such syndrome, to conduct such
p.001431: programs for health professionals (including allied health professionals), public safety workers
p.001431: (including emergency response employ- ees), teachers, school administrators, and other appropriate education
p.001431: personnel;
p.001431: (7) to conduct appropriate programs for educating school- aged children with respect to such syndrome,
p.001431: after consulting with local school boards;
p.001431: (8) to make available to physicians and dentists in the State information with respect to acquired
p.001431: immune deficiency syndrome, including measures for the prevention of exposure to, and the transmission of,
p.001431: the etiologic agent for such syn- drome (which information is updated not less than annually with the
p.001431: most recently available scientific date 2 relating to such syndrome);
p.001431: (9) to carry out the initial implementation of recommenda- tions contained in the guidelines and the model curriculum
p.001431: de- veloped under section 253 of the AIDS Amendments of 1988; and
p.001431: (10) to make grants to public entities, and to nonprofit pri- vate entities concerned with acquired immune
p.001431: deficiency syn- drome, for the purpose of the development, establishment, and expansion of programs for education
p.001431: directed toward individ- uals at increased risk of infection with the etiologic agent for such syndrome and
p.001431: activities to reduce the risks of exposure to such etiologic agent, with preference to programs directed to-
p.001431: ward populations in which there is significant evidence of such infection.
p.001431: SEC. 2503. ø300ee–13¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001431: (a) IN GENERAL.—The Secretary may not make payments under section 2501(a) for a fiscal year unless—
p.001431: (1) the State involved submits to the Secretary a descrip- tion of the purposes for which the State intends to
p.001431: expend the payments for the fiscal year;
p.001431: (2) the description identifies the populations, areas, and lo- calities in the State with a need for the
p.001431: services for which amounts may be provided by the State under this part;
p.001431:
p.001431:
p.001431:
p.001431: January 30, 2020
p.001431: 2 So in law. Probably should be ‘‘data’’.
p.001431:
p.001431: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001431:
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p.001433: 1433
p.001433: PUBLIC HEALTH SERVICE ACT
p.001433: Sec. 2505
p.001433:
p.001433: (3) the description provides information relating to the pro- grams and activities to be supported and services
p.001433: to be pro- vided, including a description of the manner in which such pro- grams and activities will be
...

p.001435: com- munity health centers (as defined in section 330(a)) 3, and to nonprofit private entities concerned
p.001435: with ac- quired immune deficiency syndrome; or
p.001435: (ii) to enter into contracts with public and private entities; and
p.001435: (B) of the amounts reserved for a fiscal year by the State for expenditures required in subparagraph
p.001435: (A), ex- pend not less than 50 percent to carry out section 2502(10) through grants to nonprofit private
p.001435: entities, including mi- nority entities, concerned with acquired immune deficiency syndrome located in and
p.001435: representative of communities and subpopulations reflecting the local incidence of such syndrome;
p.001435: (6) with respect to programs carried out pursuant to sec- tion 2502(10), the State will ensure that any
p.001435: applicant for a grant under such section agrees—
p.001435: (A) that any educational or informational materials developed with a grant pursuant to such section will
p.001435: con- tain material, and be presented in a manner, that is spe- cifically directed toward the group for
p.001435: which such mate- rials are intended;
p.001435: (B) to provide a description of the manner in which the applicant has planned the program in
p.001435: consultation with, and of the manner in which such applicant will con- sult during the conduct of the program with—
p.001435: (i) appropriate local officials and community groups for the area to be served by the program;
p.001435: (ii) organizations comprised of, and representing, the specific population to which the education or pre-
p.001435: vention effort is to be directed; and
p.001435: (iii) individuals having expertise in health edu- cation and in the needs of the population to be served;
p.001435: (C) to provide information demonstrating that the ap- plicant has continuing relationships, or will
p.001435: establish con-
p.001435:
p.001435:
p.001435:
p.001435: January 30, 2020
p.001435: 3 See footnote for section 217(a).
p.001435:
p.001435: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001435:
p.001435:
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p.001435:
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p.001435:
p.001435: Sec. 2507 PUBLIC HEALTH SERVICE ACT 1436
p.001435:
p.001435: tinuing relationships, with a portion of the population in the service area that is at risk of
p.001435: infection with the etio- logic agent for acquired immune deficiency syndrome and with public and private
p.001435: entities in such area that provide health or other support services to individuals with such infection;
p.001435: (D) to provide a description of—
p.001435: (i) the objectives established by the applicant for the conduct of the program; and
p.001435: (ii) the methods the applicant will use to evaluate the activities conducted under the program to deter- mine if
p.001435: such objectives are met; and
p.001435: (E) such other information as the Secretary may pre- scribe;
p.001435: (7) with respect to programs carried out pursuant to sec- tion 2502(10), the State will give preference
...

p.001475: other facility, or to make cash payments to intended recipients of services.
p.001475: SEC. 2613. ø300ff–23¿ GRANTS TO ESTABLISH HIV CARE CONSORTIA.
p.001475: (a) CONSORTIA.—A State may, subject to subsection (f), use amounts provided under a grant awarded under
p.001475: section 2611 to provide assistance under section 2612(a) to an entity that—
p.001475: (1) is an association of one or more public, and one or more nonprofit private, (or private for-profit providers
p.001475: or organiza- tions if such entities are the only available providers of quality HIV care in the area) health care and
p.001475: support service providers and community based organizations operating within areas de- termined by the State to be
p.001475: most affected by HIV/AIDS; and
p.001475: (2) agrees to use such assistance for the planning, develop- ment and delivery, through the direct provision of
p.001475: services or through entering into agreements with other entities for the provision of such services, of
p.001475: comprehensive outpatient health and support services for individuals with HIV disease, that may include—
p.001475: (A) essential health services such as case management services, medical, nursing, substance abuse treatment,
p.001475: mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for
p.001475: opportunistic infec- tions, treatment education to take place in the context of health care delivery, and
p.001475: medical follow-up services, men- tal health, developmental, and rehabilitation services, home health and
p.001475: hospice care; and
p.001475: (B) essential support services such as transportation services, attendant care, homemaker services, day or
p.001475: res- pite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and
p.001475: services that are incidental to the provision of health care services for individuals with HIV/AIDS including nutrition
p.001475: services, housing referral services, and child welfare and family services (including foster care and adoption
p.001475: services).
p.001475: An entity or entities of the type described in this subsection shall hereinafter be referred to in this
p.001475: title as a ‘‘consortium’’ or ‘‘con- sortia’’.
p.001475: (b) ASSURANCES.—
p.001475: (1) REQUIREMENT.—To receive assistance from a State under subsection (a), an applicant consortium shall
p.001475: provide the State with assurances that—
p.001475: (A) within any locality in which such consortium is to operate, the populations and subpopulations of individuals and
p.001475: families with HIV/AIDS have been identified by the consortium, particularly those experiencing disparities
p.001475: in
p.001475: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001475:
p.001475:
p.001475:
p.001475:
p.001475:
p.001475:
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p.001507:
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p.001507: January 30, 2020
p.001507:
p.001507: tem, and tests to provide information on appropriate therapeutic measures for preventing and treating the
p.001507: dete- rioration of the immune system and for preventing and treating conditions arising from HIV/AIDS;
p.001507: (C) referrals described in paragraph (2);
p.001507: (D) other clinical and diagnostic services regarding HIV/AIDS, and periodic medical evaluations of individuals
p.001507: with HIV/AIDS; and
p.001507: (E) providing the therapeutic measures described in subparagraph (B).
p.001507: (2) REFERRALS.—The services referred to in paragraph (1)(C) are referrals of individuals with
p.001507: HIV/AIDS to appro- priate providers of health and support services, including, as appropriate—
p.001507: (A) to entities receiving amounts under part A or B for the provision of such services;
p.001507: (B) to biomedical research facilities of institutions of higher education that offer experimental treatment
p.001507: for such disease, or to community-based organizations or other entities that provide such treatment; or
p.001507: (C) to grantees under section 2671, in the case of a pregnant woman.
p.001507: (3) REQUIREMENT OF AVAILABILITY OF ALL EARLY INTERVEN- TION SERVICES THROUGH EACH GRANTEE.—
p.001507: (A) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the applicant for
p.001507: the grant agrees that each of the early intervention services specified in paragraph (2) will be
p.001507: available through the grantee. With respect to compliance with such agreement, such a grantee may expend the grant to
p.001507: provide the early intervention services directly, and may expend the grant to enter into agreements with public or
p.001507: nonprofit private en- tities, or private for-profit entities if such entities are the only available
p.001507: provider of quality HIV care in the area, under which the entities provide the services.
p.001507: (B) OTHER REQUIREMENTS.—Grantees described in—
p.001507: (i) subparagraphs (A), (D), (E), and (F) of section 2652(a)(1) shall use not less than 50 percent of
p.001507: the amount of such a grant to provide the services de- scribed in subparagraphs (A), (B), (D), and (E) of
p.001507: para- graph (1) directly and on-site or at sites where other primary care services are rendered; and
p.001507: (ii) subparagraphs (B) and (C) of section 2652(a)(1) shall ensure the availability of early intervention serv- ices
p.001507: through a system of linkages to community-based primary care providers, and to establish mechanisms for the
...

p.001511: of early intervention services pursuant to the grant is maintained confidentially in a manner not inconsistent with
p.001511: applicable law.
p.001511: (b) INFORMED CONSENT.—The Secretary may not make a grant under this part unless the applicant for the grant
p.001511: agrees that, in testing an individual for HIV/AIDS, the applicant will test an indi- vidual only after the individual
p.001511: confirms that the decision of the in- dividual with respect to undergoing such testing is voluntarily made.
p.001511: SEC. 2662. ø300ff–62¿ PROVISION OF CERTAIN COUNSELING SERVICES.
p.001511: (a) COUNSELING OF INDIVIDUALS WITH NEGATIVE TEST RE- SULTS.—The Secretary may not make a grant
p.001511: under this part un- less the applicant for the grant agrees that, if the results of testing conducted for HIV/AIDS
p.001511: indicate that an individual does not have such condition, the applicant will provide the individual
p.001511: informa- tion, including—
p.001511: (1) measures for prevention of, exposure to, and trans- mission of HIV/AIDS, hepatitis B, hepatitis C, and
p.001511: other sexu- ally transmitted diseases;
p.001511: (2) the accuracy and reliability of results of testing for HIV/AIDS, hepatitis B, and hepatitis C;
p.001511: (3) the significance of the results of such testing, including the potential for developing AIDS, hepatitis B,
p.001511: or hepatitis C;
p.001511: (4) the appropriateness of further counseling, testing, and education of the individual regarding HIV/AIDS and
p.001511: other sex- ually transmitted diseases;
p.001511: (5) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001511: liver dis- ease and its impact on HIV/AIDS; and
p.001511: (6) information regarding the availability of hepatitis B vaccine and information about hepatitis treatments.
p.001511: (b) COUNSELING OF INDIVIDUALS WITH POSITIVE TEST RE- SULTS.—The Secretary may not make a
p.001511: grant under this part un- less the applicant for the grant agrees that, if the results of testing for HIV/AIDS
p.001511: indicate that the individual has such condition, the applicant will provide to the individual appropriate
p.001511: counseling re- garding the condition, including—
p.001511: (1) information regarding—
p.001511: (A) measures for prevention of, exposure to, and trans- mission of HIV/AIDS, hepatitis B, and hepatitis C;
p.001511: (B) the accuracy and reliability of results of testing for HIV/AIDS, hepatitis B, and hepatitis C; and
p.001511: (C) the significance of the results of such testing, in- cluding the potential for developing AIDS,
p.001511: hepatitis B, or hepatitis C;
p.001511: (2) reviewing the appropriateness of further counseling, testing, and education of the individual regarding
p.001511: HIV/AIDS and other sexually transmitted diseases; and
p.001511: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001511:
p.001511:
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p.001511:
p.001511:
p.001513: 1513
p.001513: PUBLIC HEALTH SERVICE ACT
p.001513: Sec. 2663
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p.001513: January 30, 2020
p.001513: (3) providing counseling—
p.001513: (A) on the availability, through the applicant, of early intervention services;
p.001513: (B) on the availability in the geographic area of appro- priate health care, mental health care, and social and sup-
p.001513: port services, including providing referrals for such serv- ices, as appropriate;
p.001513: (C)(i) that explains the benefits of locating and coun- seling any individual by whom the infected individual
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p.001517: Sec. 2667 PUBLIC HEALTH SERVICE ACT 1518
p.001517:
p.001517: (b) LIMITATION.—With respect to a request described in sub- section (a), the Secretary shall reduce the
p.001517: amount of payments under the grant involved by an amount equal to the costs of detail- ing personnel and the fair
p.001517: market value of any supplies, equip- ment, or services provided by the Secretary. The Secretary shall,
p.001517: for the payment of expenses incurred in complying with such re- quest, expend the amounts withheld.
p.001517: SEC. 2667. ø300ff–67¿ USE OF FUNDS.
p.001517: Counseling programs carried out under this part—
p.001517: (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity,
p.001517: homosexual or het- erosexual;
p.001517: (2) shall be designed to reduce exposure to and trans- mission of HIV/AIDS by providing accurate information;
p.001517: (3) shall provide information on the health risks of promis- cuous sexual activity and intravenous drug abuse; amd
p.001517: (4) shall provide information on the transmission and pre- vention of hepatitis A, B, and C, including education about
p.001517: the availability of hepatitis A and B vaccines and assisting pa- tients in identifying vaccination sites.
p.001517:
p.001517: PART D—WOMEN, INFANTS, CHILDREN, AND YOUTH
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p.001517: January 30, 2020
p.001517: SEC. 2671. ø300ff–71¿ GRANTS FOR COORDINATED SERVICES AND AC- CESS TO RESEARCH FOR WOMEN, INFANTS,
p.001517: CHILDREN, AND YOUTH.
p.001517: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001517: Administration, shall award grants to public and nonprofit private entities (including a health facility
p.001517: operated by or pursuant to a contract with the In- dian Health Service) for the purpose of providing
p.001517: family-centered care involving outpatient or ambulatory care (directly or through contracts or memoranda of
p.001517: understanding) for women, infants, chil- dren, and youth with HIV/AIDS.
p.001517: (b) ADDITIONAL SERVICES FOR PATIENTS AND FAMILIES.—Funds provided under grants awarded under subsection (a)
p.001517: may be used for the following support services:
p.001517: (1) Family-centered care including case management.
p.001517: (2) Referrals for additional services including—
p.001517: (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and
p.001517: (B) referrals for other social and support services, as appropriate.
p.001517: (3) Additional services necessary to enable the patient and the family to participate in the program established by the
p.001517: ap- plicant pursuant to such subsection including services designed to recruit and retain youth with HIV.
p.001517: (4) The provision of information and education on opportu- nities to participate in HIV/AIDS-related clinical research.
p.001517: (c) COORDINATION WITH OTHER ENTITIES.—A grant awarded under subsection (a) may be made only if the applicant
p.001517: provides an agreement that includes the following:
p.001517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001517:
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p.001519: 1519
p.001519: PUBLIC HEALTH SERVICE ACT
p.001519: Sec. 2671
p.001519:
p.001519: (1) The applicant will coordinate activities under the grant with other providers of health care services under this
p.001519: Act, and under title V of the Social Security Act, including programs promoting the reduction and
p.001519: elimination of risk of HIV/AIDS for youth.
p.001519: (2) The applicant will participate in the statewide coordi- nated statement of need under part B (where it has
p.001519: been initi- ated by the public health agency responsible for administering grants under part B) and in revisions of
p.001519: such statement.
p.001519: (3) The applicant will every 2 years submit to the lead State agency under section 2617(b)(4) audits
p.001519: regarding funds expended in accordance with this title and shall include nec- essary client-level data to
p.001519: complete unmet need calculations and Statewide coordinated statements of need process.
...

p.001525: (c) COORDINATION.—The Secretary may not make a grant under this section unless the applicant
p.001525: submits evidence that the proposed program is consistent with the statewide coordinated statement of need,
p.001525: and the applicant agrees to participate in the ongoing revision process of such statement of need.
p.001525: (d) PRIVACY PROTECTION.—The Secretary may not make a grant under this section for the development
p.001525: of a qualified health information technology system unless the applicant provides assur- ances to the Secretary that
p.001525: the system will, at a minimum, comply
p.001525: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001525:
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p.001527: 1527
p.001527: PUBLIC HEALTH SERVICE ACT
p.001527: Sec. 2692
p.001527:
p.001527: with the privacy regulations promulgated under section 264(c) of the Health Insurance Portability and
p.001527: Accountability Act of 1996.
p.001527: (e) REPLICATION.—The Secretary shall make information con- cerning successful models or programs developed
p.001527: under this part available to grantees under this title for the purpose of coordina- tion, replication,
p.001527: and integration. To facilitate efforts under this subsection, the Secretary may provide for peer-based
p.001527: technical as- sistance for grantees funded under this part.
p.001527: Subpart II—AIDS Education and Training Centers
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p.001527: January 30, 2020
p.001527: SEC. 2692. ø300ff–111¿ HIV/AIDS COMMUNITIES, SCHOOLS, AND CEN- TERS.
p.001527: (a) SCHOOLS; CENTERS.—
p.001527: (1) IN GENERAL.—The Secretary may make grants and enter into contracts to assist public and nonprofit private
p.001527: enti- ties and schools and academic health science centers in meet- ing the costs of projects—
p.001527: (A) to train health personnel, including practitioners in programs under this title and other community
p.001527: pro- viders, in the diagnosis, treatment, and prevention of HIV/ AIDS, including the prevention of the perinatal
p.001527: trans- mission of the disease, including measures for the preven- tion and treatment of opportunistic infections, and
p.001527: includ- ing (as applicable to the type of health professional in- volved), prenatal and other
p.001527: gynecological care for women with HIV/AIDS;
p.001527: (B) to train the faculty of schools of, and graduate de- partments or programs of, medicine, nursing, osteopathic
p.001527: medicine, dentistry, public health, allied health, and men- tal health practice to teach health professions
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p.001527: professionals to provide treatment for individuals with such disease; and
p.001527: (C) train or result in the training of health profes- sionals and allied health professionals to provide
p.001527: treat- ment for hepatitis B or C co-infected individuals.
p.001527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001527:
p.001527:
p.001527:
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p.001527:
p.001527: Sec. 2692 PUBLIC HEALTH SERVICE ACT 1528
p.001527:
p.001527: (3) APPLICATION.—No grant or contract may be made under paragraph (1) unless an application is
p.001527: submitted to the Secretary in such form, at such time, and containing such in- formation, as the Secretary
p.001527: may prescribe.
p.001527: (b) DENTAL SCHOOLS.—
p.001527: (1) IN GENERAL.—
p.001527: (A) GRANTS.—The Secretary may make grants to den- tal schools and programs described in subparagraph (B) to assist
p.001527: such schools and programs with respect to oral health care to patients with HIV/AIDS.
p.001527: (B) ELIGIBLE APPLICANTS.—For purposes of this sub- section, the dental schools and programs referred to in this
p.001527: subparagraph are dental schools and programs that were described in section 777(b)(4)(B) as such section was in
p.001527: ef- fect on the day before the date of the enactment of the Health Professions Education Partnerships
p.001527: Act of 1998 (Public Law 105–392) and in addition dental hygiene pro- grams that are accredited by the
p.001527: Commission on Dental Accreditation.
p.001527: (2) APPLICATION.—Each dental school or program described in section 15 the section referred to in paragraph (1)(B)
p.001527: may an- nually submit an application documenting the unreimbursed costs of oral health care provided to
p.001527: patients with HIV/AIDS by that school or hospital during the prior year.
p.001527: (3) DISTRIBUTION.—The Secretary shall distribute the available funds among all eligible applicants,
p.001527: taking into ac- count the number of patients with HIV/AIDS served and the unreimbursed oral health care
p.001527: costs incurred by each institu- tion as compared with the total number of patients served and costs incurred by all
p.001527: eligible applicants.
p.001527: (4) MAINTENANCE OF EFFORT.—The Secretary shall not make a grant under this subsection if doing so would result in
p.001527: any reduction in State funding allotted for such purposes.
p.001527: (5) COMMUNITY-BASED CARE.—The Secretary may make grants to dental schools and programs described in
p.001527: paragraph (1)(B) that partner with community-based dentists to provide oral health care to patients with
p.001527: HIV/AIDS in unserved areas. Such partnerships shall permit the training of dental students and residents and the
p.001527: participation of community dentists as adjunct faculty.
p.001527: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.001527: (1) SCHOOLS; CENTERS.—For the purpose of awarding grants under subsection (a), there are authorized
...

p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
p.001529:
p.001529:
p.001529:
p.001529:
p.001529:
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p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001529:
p.001531: 1531
p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
p.001531:
p.001531: (1) The schedule for carrying out subsection (b)(1)(A) shall be the same as the schedule applicable to emergency
p.001531: assistance under part A.
p.001531: (2) The schedule for carrying out subsection (b)(1)(B) shall be the same as the schedule applicable to care
p.001531: grants under part B.
p.001531: (3) The schedule for carrying out subsection (b)(1)(C) shall be the same as the schedule applicable to grants
p.001531: for early intervention services under part C.
p.001531: (4) The schedule for carrying out subsection (b)(1)(D) shall be the same as the schedule applicable to grants
p.001531: for services through projects for HIV-related care under part D.
p.001531: (5) The schedule for carrying out subsection (b)(1)(E) shall be the same as the schedule applicable to grants and
p.001531: contracts for activities through education and training centers under sec- tion 2692.
p.001531:
p.001531: PART G—NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES
p.001531:
p.001531:
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p.001531: January 30, 2020
p.001531: SEC. 2695. ø300ff–131¿ INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT TO NOTIFICATION REQUIREMENTS.
p.001531: (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this part, the Secretary shall
p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
p.001531: (b) SPECIFICATION OF AIRBORNE INFECTIOUS DISEASES.—The list developed by the Secretary under subsection (a)(1)
p.001531: shall include a specification of those infectious diseases on the list that are rou- tinely transmitted through
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p.001553: standard that is related to a health status factor, such wellness program shall not violate this section if the
p.001553: requirements of para- graph (3) are complied with.
p.001553: (2) WELLNESS PROGRAMS NOT SUBJECT TO REQUIRE- MENTS.—If none of the conditions for obtaining a
p.001553: premium dis- count or rebate or other reward under a wellness program as described in paragraph (1)(B) are
p.001553: based on an individual satis- fying a standard that is related to a health status factor (or if such a wellness program
p.001553: does not provide such a reward), the wellness program shall not violate this section if participation in the
p.001553: program is made available to all similarly situated indi- viduals. The following programs shall not have to comply with
p.001553: the requirements of paragraph (3) if participation in the pro- gram is made available to all similarly
p.001553: situated individuals:
p.001553: (A) A program that reimburses all or part of the cost for memberships in a fitness center.
p.001553: (B) A diagnostic testing program that provides a re- ward for participation and does not base any part
p.001553: of the reward on outcomes.
p.001553: (C) A program that encourages preventive care related to a health condition through the waiver of the copayment or
p.001553: deductible requirement under group health plan for the costs of certain items or services related to a health condi-
p.001553: tion (such as prenatal care or well-baby visits).
p.001553: (D) A program that reimburses individuals for the costs of smoking cessation programs without regard to
p.001553: whether the individual quits smoking.
p.001553: (E) A program that provides a reward to individuals for attending a periodic health education seminar.
p.001553: (3) WELLNESS PROGRAMS SUBJECT TO REQUIREMENTS.—If any of the conditions for obtaining a premium discount,
p.001553: rebate, or reward under a wellness program as described in paragraph (1)(C) is based on an individual satisfying
p.001553: a standard that is related to a health status factor, the wellness program shall not violate this
p.001553: section if the following requirements are com- plied with:
p.001553: (A) The reward for the wellness program, together with the reward for other wellness programs with
p.001553: respect to the plan that requires satisfaction of a standard related to a health status factor, shall not exceed 30
p.001553: percent of the cost of employee-only coverage under the plan. If, in addi- tion to employees or individuals, any
p.001553: class of dependents (such as spouses or spouses and dependent children) may participate fully in the
p.001553: wellness program, such reward shall not exceed 30 percent of the cost of the coverage in which an
p.001553: employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of cov-
p.001553: erage shall be determined based on the total amount of employer and employee contributions for the benefit
p.001553: pack- age under which the employee is (or the employee and any dependents are) receiving coverage. A reward may
p.001553: be in the form of a discount or rebate of a premium or contribu-
p.001553: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001553:
p.001553:
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p.001565: (b) RULES AND DEFINITIONS.—For purposes of this section—
p.001565: (1) CERTAIN RULES TO APPLY.—Rules similar to the rules contained in paragraphs (3), (4), and (8) of
p.001565: section 105(h) of such Code shall apply.
p.001565: (2) HIGHLY COMPENSATED INDIVIDUAL.—The term ‘‘highly compensated individual’’ has the meaning given such
p.001565: term by section 105(h)(5) of such Code.
p.001565: SEC. 2717. ø300gg–17¿ ENSURING THE QUALITY OF CARE.
p.001565: (a) QUALITY REPORTING.—
p.001565: (1) IN GENERAL.—Not later than 2 years after the date of enactment of the Patient Protection and
p.001565: Affordable Care Act, the Secretary, in consultation with experts in health care qual- ity and stakeholders, shall
p.001565: develop reporting requirements for use by a group health plan, and a health insurance issuer of- fering
p.001565: group or individual health insurance coverage, with re- spect to plan or coverage benefits and health care
p.001565: provider re- imbursement structures that—
p.001565: (A) improve health outcomes through the implementa- tion of activities such as quality reporting, effective
p.001565: case management, care coordination, chronic disease manage- ment, and medication and care compliance
p.001565: initiatives, in- cluding through the use of the medical homes model as de- fined for purposes of section 3602 of the
p.001565: Patient Protection and Affordable Care Act, for treatment or services under the plan or coverage;
p.001565: (B) implement activities to prevent hospital readmis- sions through a comprehensive program for hospital
p.001565: dis- charge that includes patient-centered education and coun- seling, comprehensive discharge planning, and
p.001565: post dis- charge reinforcement by an appropriate health care profes- sional;
p.001565: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001565:
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p.001565:
p.001565: Sec. 2717 PUBLIC HEALTH SERVICE ACT 1566
p.001565: (C) implement activities to improve patient safety and reduce medical errors through the appropriate use of
p.001565: best clinical practices, evidence based medicine, and health in- formation technology under the plan or
p.001565: coverage; and
p.001565: (D) implement wellness and health promotion activi-
p.001565:
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p.001565: January 30, 2020
p.001565: ties.
p.001565: (2) REPORTING REQUIREMENTS.—
p.001565: (A) IN GENERAL.—A group health plan and a health in- surance issuer offering group or individual health insur-
p.001565: ance coverage shall annually submit to the Secretary, and to enrollees under the plan or coverage, a report on wheth-
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p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
p.001585: (2) DEPENDENT CHILD DESCRIBED.—A dependent child de- scribed in this paragraph is, with respect to a
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p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
p.001585: (a) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health
p.001585: insurance coverage shall—
p.001585:
p.001585:
p.001585:
p.001585:
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p.001607: health insurance issuer in connection with a group health plan in the small or large group market.
p.001607: SEC. 2753. 24 ø300gg–53¿ PROHIBITION OF HEALTH DISCRIMINATION ON THE BASIS OF GENETIC INFORMATION.
p.001607: (a) PROHIBITION ON GENETIC INFORMATION AS A CONDITION OF
p.001607: ELIGIBILITY.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market may not establish
p.001607: rules for the eligibility (including continued eligibility) of any individual to enroll in individual
p.001607: health insurance coverage based on genetic information.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from establishing rules for eligibility for an
p.001607: individual to enroll in individual health in- surance coverage based on the manifestation of a disease or
p.001607: disorder in that individual, or in a family member of such indi- vidual where such family member is covered
p.001607: under the policy that covers such individual.
p.001607: (b) PROHIBITION ON GENETIC INFORMATION IN SETTING PRE-
p.001607: MIUM RATES.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001607: adjust
p.001607:
p.001607:
p.001607:
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p.001607:
p.001607:
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p.001607:
p.001607:
p.001607: January 30, 2020
p.001607: 23 Section 2752 was added by subsection (b) of section 903 of the Departments of Labor, Health and Human
p.001607: Services, and Education, and Related Agencies Appropriations Act, 1999 (as contained in section 101(f) of division A of
p.001607: Public Law 105–277 (112 Stat. 2681–438)). Subsection
p.001607: (c) of such section 903 concerns effective dates, and paragraph (2) of the subsection provides as follows:
p.001607: ‘‘(2) INDIVIDUAL PLANS.—The amendment made by subsection (b) shall apply with respect to health insurance coverage
p.001607: offered, sold, issued, renewed, in effect, or operated in the indi- vidual market on or after the date of enactment of
p.001607: this Act.’’.
p.001607: The Public Law was enacted October 21, 1998.
p.001607: 24 Another section designated as section 2753 appears at the end of part B. There are details in a footnote regarding
p.001607: its placement at the end.
p.001607: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001607: Sec. 2753 PUBLIC HEALTH SERVICE ACT 1608
p.001607:
p.001607: premium or contribution amounts for an individual on the basis of genetic information concerning the individual
p.001607: or a fam- ily member of the individual.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from adjusting premium or contribution amounts for an
p.001607: individual on the basis of a manifestation of a disease or disorder in that individual, or in a family member of
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p.001615: (i) an analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes;
p.001615: or
p.001615: (ii) an analysis of proteins or metabolites that is directly related to a manifested disease, disorder,
p.001615: or pathological condition that could reasonably be de- tected by a health care professional with
p.001615: appropriate training and expertise in the field of medicine in- volved.
p.001615: (18) GENETIC SERVICES.—The term ‘‘genetic services’’ means—
p.001615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001615: Sec. 2791 PUBLIC HEALTH SERVICE ACT 1616
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p.001615: January 30, 2020
p.001615:
p.001615: (A) a genetic test;
p.001615: (B) genetic counseling (including obtaining, inter- preting, or assessing genetic information); or
p.001615: (C) genetic education.
p.001615: (19) UNDERWRITING PURPOSES.—The term ‘‘underwriting purposes’’ means, with respect to any group health
p.001615: plan, or health insurance coverage offered in connection with a group health plan—
p.001615: (A) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the
p.001615: plan or coverage;
p.001615: (B) the computation of premium or contribution amounts under the plan or coverage;
p.001615: (C) the application of any pre-existing condition exclu- sion under the plan or coverage; and
p.001615: (D) other activities related to the creation, renewal, or replacement of a contract of health insurance or
p.001615: health benefits.
p.001615: (20) QUALIFIED HEALTH PLAN.—The term ‘‘qualified health plan’’ has the meaning given such term in section
p.001615: 1301(a) of the Patient Protection and Affordable Care Act.
p.001615: (21) EXCHANGE.—The term ‘‘Exchange’’ means an Amer- ican Health Benefit Exchange established under section
p.001615: 1311 of the Patient Protection and Affordable Care Act.
p.001615: (e) DEFINITIONS RELATING TO MARKETS AND SMALL EMPLOY-
p.001615: ERS.—For purposes of this title:
p.001615: (1) INDIVIDUAL MARKET.—
p.001615: (A) IN GENERAL.—The term ‘‘individual market’’ means the market for health insurance coverage offered to indi-
p.001615: viduals other than in connection with a group health plan.
p.001615: (B) TREATMENT OF VERY SMALL GROUPS.—
p.001615: (i) IN GENERAL.—Subject to clause (ii), such terms includes coverage offered in connection with a group health
...

p.001627: (iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing ca-
p.001627: pabilities) of all products in the Strategic National Stockpile;
p.001627: (iv) the availability of technologies that may assist in the advanced research and development of counter- measures
p.001627: and opportunities to use such technologies to accelerate and navigate challenges unique to coun- termeasure
p.001627: research and development; and
p.001627: (v) potential deployment, distribution, and utiliza- tion of medical countermeasures; development of clin- ical
p.001627: guidance and emergency use instructions for the use of medical countermeasures; and, as applicable,
p.001627: potential postdeployment activities related to medical countermeasures;
p.001627: (B) inform prioritization of resources and include measurable outputs and outcomes to allow for the
p.001627: tracking of the progress made toward identified priorities;
p.001627: (C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs
p.001627: within the continuum of the medical countermeasure enterprise consistent with section 319F–2;
p.001627: (D) identify the full range of anticipated medical coun- termeasure needs related to research and development,
p.001627: procurement, and stockpiling, including the potential need for indications, dosing, and administration
p.001627: technologies, and other countermeasure needs as applicable and appro- priate;
p.001627: (E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Com-
p.001627: mittee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations
p.001627: and the Committee on Energy and Commerce of the House of Rep- resentatives; and
p.001627: (F) not later than March 15 of each year, be made publicly available in a manner that does not
p.001627: compromise national security.
p.001627: (c) FUNCTIONS.—The Assistant Secretary for Preparedness and Response shall—
p.001627: (1) have lead responsibility within the Department of Health and Human Services for emergency
p.001627: preparedness and response policy coordination and strategic direction;
p.001627: (2) have authority over and responsibility for—
p.001627: (A) the National Disaster Medical System pursuant to section 2812;
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001627:
p.001629: 1629
p.001629: PUBLIC HEALTH SERVICE ACT
p.001629: Sec. 2811
p.001629:
p.001629: (B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2;
p.001629: (C) the Biomedical Advanced Research and Develop- ment Authority pursuant to section 319L;
p.001629: (D) the Medical Reserve Corps pursuant to section 2813;
p.001629: (E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and
p.001629:
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p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
p.001635: more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
p.001635: (e) MEETINGS.—The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be
p.001635: an in-per- son meeting.
p.001635: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001635: accordance with section 2811D.
p.001635: (g) SUNSET.—The Advisory Committee shall terminate on Sep- tember 30, 2023.
p.001635: SEC. 2811B. ø42 U.S.C. 300hh-10c¿ NATIONAL ADVISORY COMMITTEE ON SENIORS AND DISASTERS.
p.001635: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security and the Secretary
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p.001651: Sec. 2903 PUBLIC HEALTH SERVICE ACT 1652
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p.001651: (iv) to provide information to caregivers about available respite and support services; and
p.001651: (v) to assist caregivers in gaining access to such services.
p.001651: (B) OPTIONAL USES OF FUNDS.—Each eligible State agency awarded a grant or cooperative agreement under this
p.001651: section may use part of the funds for—
p.001651: (i) training programs for family caregivers to as- sist such family caregivers in making informed deci-
p.001651: sions about respite care services;
p.001651: (ii) other services essential to the provision of res- pite care as the Secretary may specify; or
p.001651: (iii) training and education for new caregivers.
p.001651: (2) SUBCONTRACTS.—Each eligible State agency awarded a grant or cooperative agreement under this section may
p.001651: carry out the activities described in paragraph (1) directly or by grant to, or contract with, public or
p.001651: private entities.
p.001651: (3) MATCHING FUNDS.—
p.001651: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out under paragraph (1), a
p.001651: condition for the receipt of a grant or cooperative agreement under this section is that the eligible
p.001651: State agency agrees to make available (directly or through donations from public or private entities)
p.001651: non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs.
p.001651: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions required by subparagraph (A) may be
p.001651: in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the
p.001651: Federal Government, or services assisted or subsidized to any sig- nificant extent by the Federal Government,
p.001651: may not be in- cluded in determining the amount of such non-Federal con- tributions.
p.001651: (g) TERM OF GRANTS OR COOPERATIVE AGREEMENTS.—
p.001651: (1) IN GENERAL.—The Secretary shall award grants or co- operative agreements under this section for terms
p.001651: that do not exceed 5 years.
p.001651: (2) RENEWAL.—The Secretary may renew a grant or coop- erative agreement under this section at the end of the
p.001651: term of the grant or cooperative agreement determined under para- graph (1).
p.001651: (h) MAINTENANCE OF EFFORT.—Funds made available under this section shall be used to supplement and not
...

p.001653: and use of health information among all the components in the health care infrastructure in accordance with
p.001653: applicable law, and such term includes related application protocols and other related standards.
p.001653: (3) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ includes a hospital, skilled nursing
p.001653: facility, nursing fa- cility, home health entity or other long term care facility, health care clinic,
p.001653: community mental health center (as defined in section 1913(b)(1)), renal dialysis facility, blood center, am-
p.001653: bulatory surgical center described in section 1833(i) of the So- cial Security Act, emergency medical
p.001653: services provider, Feder- ally qualified health center, group practice, a pharmacist, a pharmacy, a
p.001653: laboratory, a physician (as defined in section
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001653: Sec. 3000 PUBLIC HEALTH SERVICE ACT 1654
p.001653:
p.001653: 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security
p.001653: Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in
p.001653: the Indian Self-Determina- tion and Education Assistance Act), tribal organization, or urban Indian
p.001653: organization (as defined in section 4 of the In- dian Health Care Improvement Act), a rural health
p.001653: clinic, a covered entity under section 340B, an ambulatory surgical cen- ter described in section 1833(i) of the
p.001653: Social Security Act, a therapist (as defined in section 1848(k)(3)(B)(iii) of the Social Security Act),
p.001653: and any other category of health care facility, entity, practitioner, or clinician determined appropriate by the
p.001653: Secretary.
p.001653: (4) HEALTH INFORMATION.—The term ‘‘health information’’ has the meaning given such term in section 1171(4) of
p.001653: the So- cial Security Act.
p.001653: (5) HEALTH INFORMATION TECHNOLOGY.—The term ‘‘health information technology’’ means hardware, software,
p.001653: integrated technologies or related licenses, intellectual property, up- grades, or packaged solutions
p.001653: sold as services that are de- signed for or support the use by health care entities or patients for the electronic
p.001653: creation, maintenance, access, or exchange of health information
p.001653: (6) HEALTH PLAN.—The term ‘‘health plan’’ has the mean- ing given such term in section 1171(5) of the
p.001653: Social Security Act.
p.001653: (7) HIT ADVISORY COMMITTEE.—The term ‘‘HIT Advisory Committee’’ means such Committee established under
p.001653: section 3002(a).
p.001653: (8) 1 INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION.— The term ‘‘individually identifiable health information’’
p.001653: has the meaning given such term in section 1171(6) of the Social Secu- rity Act.
...

p.001659: AND MEDICALLY UNDERSERVED AREAS.—The National Coor- dinator shall assess and publish the impact of health infor-
p.001659: mation technology in communities with health disparities and in areas with a high proportion of individuals who
p.001659: are uninsured, underinsured, and medically underserved indi- viduals (including urban and rural areas) and
p.001659: identify practices to increase the adoption of such technology by health care providers in such communities,
p.001659: and the use of health information technology to reduce and better man- age chronic diseases.
p.001659: (D) EVALUATION OF BENEFITS AND COSTS OF THE ELEC- TRONIC USE AND EXCHANGE OF HEALTH INFORMATION.—The
p.001659: National Coordinator shall evaluate and publish evidence on the benefits and costs of the electronic use
p.001659: and ex- change of health information and assess to whom these benefits and costs accrue.
p.001659: (E) RESOURCE REQUIREMENTS.—The National Coordi- nator shall estimate and publish resources required annu- ally to
p.001659: reach the goal of utilization of an electronic health record for each person in the United States by 2014,
p.001659: in- cluding—
p.001659: (i) the required level of Federal funding;
p.001659: (ii) expectations for regional, State, and private in- vestment;
p.001659: (iii) the expected contributions by volunteers to ac- tivities for the utilization of such records; and
p.001659: (iv) the resources needed to establish a health in- formation technology workforce sufficient to support this
p.001659: effort (including education programs in medical informatics and health information management).
p.001659: (7) ASSISTANCE.—The National Coordinator may provide fi- nancial assistance to consumer advocacy groups and
p.001659: not-for- profit entities that work in the public interest for purposes of defraying the cost to such
p.001659: groups and entities to participate under, whether in whole or in part, the National Technology Transfer
p.001659: Act of 1995 (15 U.S.C. 272 note).
p.001659: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001659:
p.001661: 1661
p.001661: PUBLIC HEALTH SERVICE ACT
p.001661: Sec. 3001
p.001661:
p.001661: (8) GOVERNANCE FOR NATIONWIDE HEALTH INFORMATION NETWORK.—The National Coordinator shall establish a govern-
p.001661: ance mechanism for the nationwide health information net- work.
p.001661: (9) SUPPORT FOR INTEROPERABLE NETWORKS EXCHANGE.—
p.001661: (A) IN GENERAL.—The National Coordinator shall, in collaboration with the National Institute of Standards and
p.001661: Technology and other relevant agencies within the Depart- ment of Health and Human Services, for the purpose of en-
p.001661: suring full network-to-network exchange of health infor- mation, convene public-private and public-public
p.001661: partner- ships to build consensus and develop or support a trusted exchange framework, including a
p.001661: common agreement among health information networks nationally. Such con- vention may occur at a frequency
p.001661: determined appropriate by the Secretary.
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p.001665:
p.001665:
p.001665: January 30, 2020
p.001665: specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of
p.001665: patients to seek care.
p.001665: (iii) The facilitation of secure access by an indi- vidual to such individual’s protected health informa-
p.001665: tion and access to such information by a family mem- ber, caregiver, or guardian acting on behalf of a pa-
p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
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p.001673:
p.001673: (2) DEFINITION.—For purposes of this section, the term ‘‘HIPAA privacy and security law’’ means—
p.001673: (A) the provisions of part C of title XI of the Social Se- curity Act, section 264 of the Health Insurance Portability
p.001673: and Accountability Act of 1996, and subtitle D of title IV of the Health Information Technology for
p.001673: Economic and Clinical Health Act; and
p.001673: (B) regulations under such provisions.
p.001673: (b) FLEXIBILITY.—In administering the provisions of this title, the Secretary shall have flexibility in
p.001673: applying the definition of health care provider under section 3000(3), including the authority to omit certain
p.001673: entities listed in such definition when applying such definition under this title, where appropriate.
p.001673: (c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH IN-
p.001673: FORMATION THROUGH HEALTH INFORMATION EXCHANGES.—
p.001673: (1) IN GENERAL.—The Secretary shall use existing authori- ties to encourage partnerships between health
p.001673: information ex- change organizations and networks and health care providers, health plans, and other
p.001673: appropriate entities with the goal of of- fering patients access to their electronic health information in a
p.001673: single, longitudinal format that is easy to understand, se- cure, and may be updated automatically.
p.001673: (2) EDUCATION OF PROVIDERS.—The Secretary, in coordina- tion with the Office for Civil Rights of the
p.001673: Department of Health and Human Services, shall—
p.001673: (A) educate health care providers on ways of leveraging the capabilities of health information
p.001673: exchanges (or other relevant platforms) to provide patients with ac- cess to their electronic health
p.001673: information;
p.001673: (B) clarify misunderstandings by health care providers about using health information exchanges (or other rel-
p.001673: evant platforms) for patient access to electronic health in- formation; and
p.001673: (C) to the extent practicable, educate providers about health information exchanges (or other relevant
p.001673: platforms) that employ some or all of the capabilities described in paragraph (1).
p.001673: (3) REQUIREMENTS.—In carrying out paragraph (1), the Secretary, in coordination with the Office for Civil Rights,
p.001673: shall issue guidance to health information exchanges related to best practices to ensure that the electronic
p.001673: health information pro- vided to patients is—
p.001673: (A) private and secure;
p.001673: (B) accurate;
p.001673: (C) verifiable; and
p.001673: (D) where a patient’s authorization to exchange infor- mation is required by law, easily exchanged
p.001673: pursuant to such authorization.
p.001673: (4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to preempt State laws applicable to
p.001673: patient consent for the access of information through a health informa- tion exchange (or other relevant platform) that
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p.001675: (d) EFFORTS TO PROMOTE ACCESS TO HEALTH INFORMATION.— The National Coordinator and the Office for Civil Rights
p.001675: of the De- partment of Health and Human Services shall jointly promote pa- tient access to health
p.001675: information in a manner that would ensure that such information is available in a form convenient for the pa-
p.001675: tient, in a reasonable manner, without burdening the health care provider involved.
p.001675: (e) ACCESSIBILITY OF PATIENT RECORDS.—
p.001675: (1) ACCESSIBILITY AND UPDATING OF INFORMATION.—
p.001675: (A) IN GENERAL.—The Secretary, in consultation with the National Coordinator, shall promote policies that
p.001675: en- sure that a patient’s electronic health information is acces- sible to that patient and the patient’s designees, in
p.001675: a man- ner that facilitates communication with the patient’s health care providers and other
p.001675: individuals, including re- searchers, consistent with such patient’s consent.
p.001675: (B) UPDATING EDUCATION ON ACCESSING AND EX- CHANGING PERSONAL HEALTH INFORMATION.—To promote
p.001675: awareness that an individual has a right of access to in- spect, obtain a copy of, and transmit to a
p.001675: third party a copy of such individual’s protected health information pur- suant to the Health Information
p.001675: Portability and Account- ability Act, Privacy Rule (subpart E of part 164 of title 45, Code of Federal Regulations),
p.001675: the Director of the Office for Civil Rights, in consultation with the National Coordi- nator, shall assist
p.001675: individuals and health care providers in understanding a patient’s rights to access and protect per- sonal health
p.001675: information under the Health Insurance Port- ability and Accountability Act of 1996 (Public Law 104– 191),
p.001675: including providing best practices for requesting per- sonal health information in a computable format, including using
p.001675: patient portals or third-party applications and com- mon cases when a provider is permitted to exchange
p.001675: and provide access to health information.
p.001675: (2) CERTIFYING USABILITY FOR PATIENTS.—In carrying out certification programs under section 3001(c)(5), the
p.001675: National Coordinator may require that—
p.001675: (A) the certification criteria support—
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p.001681: Individual awards shall be decided on the basis of merit.
p.001681: (3) OBJECTIVE.—The objective of the regional centers is to enhance and promote the adoption of health
p.001681: information tech- nology through—
p.001681: (A) assistance with the implementation, effective use, upgrading, and ongoing maintenance of health information
p.001681: technology, including electronic health records, to healthcare providers nationwide;
p.001681: (B) broad participation of individuals from industry, universities, and State governments;
p.001681: (C) active dissemination of best practices and research on the implementation, effective use, upgrading, and ongo- ing
p.001681: maintenance of health information technology, includ- ing electronic health records, to health care
p.001681: providers in order to improve the quality of healthcare and protect the privacy and security of health information;
p.001681: (D) participation, to the extent practicable, in health information exchanges;
p.001681: (E) utilization, when appropriate, of the expertise and capability that exists in Federal agencies other than
p.001681: the Department; and
p.001681: (F) integration of health information technology, in- cluding electronic health records, into the initial and
p.001681: ongo- ing training of health professionals and others in the healthcare industry that would be
p.001681: instrumental to improv- ing the quality of healthcare through the smooth and accu- rate electronic use and exchange of
p.001681: health information.
p.001681: (4) REGIONAL ASSISTANCE.—Each regional center shall aim to provide assistance and education to all providers in a
p.001681: region, but shall prioritize any direct assistance first to the following:
p.001681: (A) Public or not-for-profit hospitals or critical access hospitals.
p.001681: (B) Federally qualified health centers (as defined in section 1861(aa)(4) of the Social Security Act).
p.001681: (C) Entities that are located in rural and other areas that serve uninsured, underinsured, and medically
p.001681: under- served individuals (regardless of whether such area is urban or rural).
p.001681: (D) Individual or small group practices (or a consor- tium thereof) that are primarily focused on
p.001681: primary care.
p.001681: (5) FINANCIAL SUPPORT.—The Secretary may provide finan- cial support to any regional center created under this
p.001681: sub-
p.001681: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001683: PUBLIC HEALTH SERVICE ACT
p.001683: Sec. 3012
p.001683:
p.001683: section for a period not to exceed four years. The Secretary may not provide more than 50 percent of
p.001683: the capital and an- nual operating and maintenance funds required to create and maintain such a center,
p.001683: except in an instance of national eco- nomic conditions which would render this cost-share require- ment
p.001683: detrimental to the program and upon notification to Con- gress as to the justification to waive the cost-share
p.001683: require- ment.
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p.001685: under this section to a State unless the State agrees to make available non-Federal contributions (which
p.001685: may include in-kind contribu- tions) toward the costs of a grant awarded under subsection (c) in an amount equal to—
p.001685: (A) for fiscal year 2011, not less than $1 for each $10 of Federal funds provided under the grant;
p.001685: (B) for fiscal year 2012, not less than $1 for each $7 of Federal funds provided under the grant; and
p.001685: (C) for fiscal year 2013 and each subsequent fiscal year, not less than $1 for each $3 of Federal
p.001685: funds pro- vided under the grant.
p.001685: (2) AUTHORITY TO REQUIRE STATE MATCH FOR FISCAL YEARS BEFORE FISCAL YEAR 2011.—For any fiscal year during the
p.001685: grant program under this section before fiscal year 2011, the Sec- retary may determine the extent to
p.001685: which there shall be re- quired a non-Federal contribution from a State receiving a grant under this
p.001685: section.
p.001685: SEC. 3014. ø300jj–34¿ COMPETITIVE GRANTS TO STATES AND INDIAN TRIBES FOR THE DEVELOPMENT OF LOAN PROGRAMS TO
p.001685: FACILITATE THE WIDESPREAD ADOPTION OF CERTIFIED EHR TECHNOLOGY.
p.001685: (a) IN GENERAL.—The National Coordinator may award com- petitive grants to eligible entities for the
p.001685: establishment of programs for loans to health care providers to conduct the activities described in subsection (e).
p.001685: (b) ELIGIBLE ENTITY DEFINED.—For purposes of this sub- section, the term ‘‘eligible entity’’ means a
p.001685: State or Indian tribe (as defined in the Indian Self-Determination and Education Assistance Act) that—
p.001685: (1) submits to the National Coordinator an application at such time, in such manner, and containing such
p.001685: information as the National Coordinator may require;
p.001685: (2) submits to the National Coordinator a strategic plan in accordance with subsection (d) and provides to the
p.001685: National Coordinator assurances that the entity will update such plan annually in accordance with such
p.001685: subsection;
p.001685: (3) provides assurances to the National Coordinator that the entity will establish a Loan Fund in
p.001685: accordance with sub- section (c);
p.001685: (4) provides assurances to the National Coordinator that the entity will not provide a loan from the
p.001685: Loan Fund to a health care provider unless the provider agrees to—
p.001685: (A) submit reports on quality measures adopted by the Federal Government (by not later than 90 days after the
p.001685: date on which such measures are adopted), to—
p.001685: (i) the Administrator of the Centers for Medicare & Medicaid Services (or his or her designee), in the
p.001685: case of an entity participating in the Medicare pro-
p.001685: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001687: PUBLIC HEALTH SERVICE ACT
p.001687: Sec. 3014
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p.001689: ties, except that such entities may not specify the recipient or recipients of any loan issued under this
p.001689: subsection. An eligible entity may agree to reimburse a private sector en- tity for any contribution made under
p.001689: this subparagraph, except that the amount of such reimbursement may not be greater than the principal amount
p.001689: of the contribution made.
p.001689: (B) AVAILABILITY OF INFORMATION.—An eligible entity shall make publicly available the identity of, and
p.001689: amount contributed by, any private sector entity under subpara- graph (A) and may issue letters of commendation
p.001689: or make other awards (that have no financial value) to any such en- tity.
p.001689: (h) MATCHING REQUIREMENTS.—
p.001689: (1) IN GENERAL.—The National Coordinator may not make a grant under subsection (a) to an eligible entity unless the
p.001689: en- tity agrees to make available (directly or through donations from public or private entities)
p.001689: non-Federal contributions in cash to the costs of carrying out the activities for which the grant is
p.001689: awarded in an amount equal to not less than $1 for each $5 of Federal funds provided under the grant.
p.001689: (2) DETERMINATION OF AMOUNT OF NON-FEDERAL CON- TRIBUTION.—In determining the amount of
p.001689: non-Federal con- tributions that an eligible entity has provided pursuant to sub- paragraph (A), the National
p.001689: Coordinator may not include any amounts provided to the entity by the Federal Government.
p.001689: (i) EFFECTIVE DATE.—The Secretary may not make an award under this section prior to January 1, 2010.
p.001689: SEC. 3015. ø300jj–35¿ DEMONSTRATION PROGRAM TO INTEGRATE IN- FORMATION TECHNOLOGY INTO CLINICAL EDUCATION.
p.001689: (a) IN GENERAL.—The Secretary may award grants under this section to carry out demonstration projects to develop
p.001689: academic curricula integrating certified EHR technology in the clinical edu- cation of health
p.001689: professionals. Such awards shall be made on a competitive basis and pursuant to peer review.
p.001689: (b) ELIGIBILITY.—To be eligible to receive a grant under sub- section (a), an entity shall—
p.001689: (1) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001689: Sec- retary may require;
p.001689: (2) submit to the Secretary a strategic plan for integrating certified EHR technology in the clinical education
p.001689: of health
p.001689: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001689:
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p.001689: Sec. 3015 PUBLIC HEALTH SERVICE ACT 1690
p.001689: professionals to reduce medical errors, increase access to pre- vention, reduce chronic diseases, and enhance
p.001689: health care qual- ity;
p.001689: (3) be—
p.001689: (A) a school of medicine, osteopathic medicine, den- tistry, or pharmacy, a graduate program in
p.001689: behavioral or mental health, or any other graduate health professions school;
p.001689: (B) a graduate school of nursing or physician assistant studies;
p.001689: (C) a consortium of two or more schools described in subparagraph (A) or (B); or
p.001689: (D) an institution with a graduate medical education program in medicine, osteopathic medicine,
p.001689: dentistry, pharmacy, nursing, or physician assistance studies;
p.001689: (4) provide for the collection of data regarding the effec- tiveness of the demonstration project to be
p.001689: funded under the grant in improving the safety of patients, the efficiency of health care delivery, and in
p.001689: increasing the likelihood that grad- uates of the grantee will adopt and incorporate certified EHR technology,
p.001689: in the delivery of health care services; and
p.001689: (5) provide matching funds in accordance with subsection
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p.001689: January 30, 2020
p.001689: (d).
p.001689: (c) USE OF FUNDS.—
p.001689: (1) IN GENERAL.—With respect to a grant under subsection (a), an eligible entity shall—
p.001689: (A) use grant funds in collaboration with 2 or more disciplines; and
p.001689: (B) use grant funds to integrate certified EHR tech- nology into community-based clinical education.
p.001689: (2) LIMITATION.—An eligible entity shall not use amounts received under a grant under subsection (a) to purchase
p.001689: hard- ware, software, or services.
p.001689: (d) FINANCIAL SUPPORT.—The Secretary may not provide more than 50 percent of the costs of any activity for which
p.001689: assistance is provided under subsection (a), except in an instance of national eco- nomic conditions which would
p.001689: render the cost-share requirement under this subsection detrimental to the program and upon notifi- cation
p.001689: to Congress as to the justification to waive the cost-share re- quirement.
p.001689: (e) EVALUATION.—The Secretary shall take such action as may be necessary to evaluate the projects funded under this
p.001689: section and publish, make available, and disseminate the results of such eval- uations on as wide a basis as
p.001689: is practicable.
p.001689: (f) REPORTS.—Not later than 1 year after the date of enactment of this title, and annually thereafter, the Secretary
p.001689: shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate, and
p.001689: the Committee on Energy and Commerce of the House of Representatives a report that—
p.001689: (1) describes the specific projects established under this section; and
p.001689: (2) contains recommendations for Congress based on the evaluation conducted under subsection (e).
p.001689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001691: PUBLIC HEALTH SERVICE ACT
p.001691: Sec. 3018
p.001691:
p.001691: SEC. 3016. ø300jj–36¿ INFORMATION TECHNOLOGY PROFESSIONALS IN HEALTH CARE.
p.001691: (a) IN GENERAL.—The Secretary, in consultation with the Di- rector of the National Science Foundation, shall
p.001691: provide assistance to institutions of higher education (or consortia thereof) to establish or expand medical health
p.001691: informatics education programs, includ- ing certification, undergraduate, and masters degree programs, for both
p.001691: health care and information technology students to ensure the rapid and effective utilization and development of
p.001691: health informa- tion technologies (in the United States health care infrastructure).
p.001691: (b) ACTIVITIES.—Activities for which assistance may be pro- vided under subsection (a) may include the
p.001691: following:
p.001691: (1) Developing and revising curricula in medical health informatics and related disciplines.
p.001691: (2) Recruiting and retaining students to the program in- volved.
p.001691: (3) Acquiring equipment necessary for student instruction in these programs, including the installation of
p.001691: testbed net- works for student use.
p.001691: (4) Establishing or enhancing bridge programs in the health informatics fields between community colleges
p.001691: and uni- versities.
p.001691: (c) PRIORITY.—In providing assistance under subsection (a), the Secretary shall give preference to the following:
p.001691: (1) Existing education and training programs.
p.001691: (2) Programs designed to be completed in less than six months.
p.001691: SEC. 3017. ø300jj–37¿ GENERAL GRANT AND LOAN PROVISIONS.
p.001691: (a) REPORTS.—The Secretary may require that an entity receiv- ing assistance under this subtitle shall submit to the
p.001691: Secretary, not later than the date that is 1 year after the date of receipt of such assistance, a report
p.001691: that includes—
p.001691: (1) an analysis of the effectiveness of the activities for which the entity receives such assistance, as
p.001691: compared to the goals for such activities; and
p.001691: (2) an analysis of the impact of the project on health care quality and safety.
p.001691: (b) REQUIREMENT TO IMPROVE QUALITY OF CARE AND DE- CREASE IN COSTS.—The National Coordinator shall
p.001691: annually evalu- ate the activities conducted under this subtitle and shall, in award- ing grants, implement the lessons
p.001691: learned from such evaluation in a manner so that awards made subsequent to each such evaluation are made in a
p.001691: manner that, in the determination of the National Coordinator, will result in the greatest improvement in the
p.001691: quality and efficiency of health care.
p.001691: SEC. 3018. ø300jj–38¿ AUTHORIZATION FOR APPROPRIATIONS.
p.001691: For the purposes of carrying out this subtitle, there is author- ized to be appropriated such sums as may be necessary
p.001691: for each of the fiscal years 2009 through 2013.
p.001691:
p.001691:
p.001691: January 30, 2020 As Amended Through P.L. 116-94,
p.001691: Enacted December 20, 2019
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p.001701: workers (in- cluding those who are Federal employees) who responded to the September 11, 2001, terrorist
p.001701: attacks; and
p.001701: (2) initial health evaluation, monitoring, and treatment benefits to residents and other building occupants
p.001701: and area workers in New York City who were directly impacted and ad- versely affected by such attacks.
p.001701: (b) COMPONENTS OF PROGRAM.—The WTC Program includes the following components:
p.001701: (1) MEDICAL MONITORING FOR RESPONDERS.—Medical moni- toring under section 3311, including clinical examinations and
p.001701: long-term health monitoring and analysis for enrolled WTC re- sponders who were likely to have been exposed to airborne
p.001701: tox- ins that were released, or to other hazards, as a result of the September 11, 2001, terrorist attacks.
p.001701: (2) INITIAL HEALTH EVALUATION FOR SURVIVORS.—An ini- tial health evaluation under section 3321, including an
p.001701: evalua- tion to determine eligibility for followup monitoring and treat- ment.
p.001701: (3) FOLLOWUP MONITORING AND TREATMENT FOR WTC-RE- LATED HEALTH CONDITIONS FOR RESPONDERS AND
p.001701: SURVIVORS.—
p.001701: Provision under sections 3312, 3322, and 3323 of followup monitoring and treatment and payment, subject
p.001701: to the provi- sions of subsection (d), for all medically necessary health and mental health care expenses of
p.001701: an individual with respect to a WTC-related health condition (including necessary prescription drugs).
p.001701: (4) OUTREACH.—Establishment under section 3303 of an education and outreach program to potentially eligible
p.001701: individ- uals concerning the benefits under this title.
p.001701: (5) CLINICAL DATA COLLECTION AND ANALYSIS.—Collection and analysis under section 3304 of health and mental
p.001701: health data relating to individuals receiving monitoring or treatment benefits in a uniform manner in
p.001701: collaboration with the collec- tion of epidemiological data under section 3342.
p.001701: (6) RESEARCH ON HEALTH CONDITIONS.—Establishment under subtitle C of a research program on health conditions
p.001701: re- sulting from the September 11, 2001, terrorist attacks.
p.001701: (c) NO COST SHARING.—Monitoring and treatment benefits and initial health evaluation benefits are provided under
p.001701: subtitle B without any deductibles, copayments, or other cost sharing to an enrolled WTC responder or
p.001701: certified-eligible WTC survivor. Initial health evaluation benefits are provided under subtitle B without
p.001701: any deductibles, copayments, or other cost sharing to a screening- eligible WTC survivor.
p.001701: (d) PREVENTING FRAUD AND UNREASONABLE ADMINISTRATIVE COSTS.—
p.001701: (1) FRAUD.—The Inspector General of the Department of Health and Human Services shall develop and
p.001701: implement a program to review the WTC Program’s health care expendi- tures to detect fraudulent or duplicate
p.001701: billing and payment for
p.001701: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001703: (h) CONSULTATION.—The WTC Program Administrator shall engage in ongoing outreach and consultation with
p.001703: relevant stake- holders, including the WTC Health Program Steering Committees and the Advisory Committee under
p.001703: section 3302, regarding the im- plementation and improvement of programs under this title.
p.001703: (i) GAO STUDIES.—
p.001703: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001703: Sec. 3302 PUBLIC HEALTH SERVICE ACT 1704
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p.001703: January 30, 2020
p.001703:
p.001703: (1) REPORT.—Not later than 18 months after the date of the enactment of the James Zadroga 9/11 Health
p.001703: and Com- pensation Reauthorization Act, the Comptroller General of the United States shall submit to the
p.001703: Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and
p.001703: Pensions of the Senate a re- port that assesses, with respect to the WTC Program, the effec- tiveness of each of the
p.001703: following:
p.001703: (A) The quality assurance program developed and im- plemented under subsection (e).
p.001703: (B) The procedures for providing certifications of cov- erage of conditions as WTC-related health
p.001703: conditions for enrolled WTC responders under section 3312(b)(2)(B)(iii) and for screening-eligible WTC
p.001703: survivors and certified-eli- gible WTC survivors under such section as applied under section 3322(a).
p.001703: (C) Any action under the WTC Program to ensure ap- propriate payment (including the avoidance of improper
p.001703: payments), including determining the extent to which indi- viduals enrolled in the WTC Program are eligible for work-
p.001703: ers compensation or sources of health coverage, ascertaining the liability of such
p.001703: compensation or sources of health coverage, and making recommendations for en- suring effective and efficient
p.001703: coordination of benefits for in- dividuals enrolled in the WTC Program that does not place an undue burden on such
p.001703: individuals.
p.001703: (2) SUBSEQUENT ASSESSMENTS.—Not later than 6 years and 6 months after the date of enactment
p.001703: of the James Zadroga 9/11 Health and Compensation Reauthorization Act, and every 5 years thereafter
p.001703: through fiscal year 2042, the Comptroller General of the United States shall—
p.001703: (A) consult the Committee on Energy and Commerce of the House of Representatives and the Committee on
p.001703: Health, Education, Labor, and Pensions of the Senate on the objectives in assessing the WTC Program; and
p.001703: (B) prepare and submit to such Committees a report that assesses the WTC Program for the applicable
p.001703: report- ing period, including the objectives described in subpara- graph (A).
p.001703: (j) REGULATIONS.—The WTC Program Administrator is author- ized to promulgate such regulations as the
p.001703: Administrator deter- mines necessary to administer this title.
p.001703: (k) TERMINATION.—The WTC Program shall terminate on Octo- ber 1, 2090.
p.001703: SEC. 3302. ø42 U.S.C. 300mm–1¿ WTC HEALTH PROGRAM SCIENTIFIC/ TECHNICAL ADVISORY COMMITTEE; WTC HEALTH
p.001703: PRO- GRAM STEERING COMMITTEES.
p.001703: (a) ADVISORY COMMITTEE.—
p.001703: (1) ESTABLISHMENT.—The WTC Program Administrator shall establish an advisory committee to be known as the WTC
p.001703: Health Program Scientific/Technical Advisory Committee (in this subsection referred to as the ‘‘Advisory
p.001703: Committee’’) to re- view scientific and medical evidence and to make recommenda-
p.001703: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001703:
p.001703:
p.001703:
p.001703:
p.001703:
p.001703:
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p.001703:
p.001703:
p.001705: 1705
p.001705: PUBLIC HEALTH SERVICE ACT
p.001705: Sec. 3302
p.001705:
p.001705: tions to the Administrator on additional WTC Program eligi- bility criteria and on additional WTC-related
p.001705: health conditions.
p.001705: (2) COMPOSITION.—The WTC Program Administrator shall appoint the members of the Advisory Committee and shall
p.001705: in- clude at least—
...

p.001705: date of the enactment of this title).
p.001705: (B) WTC SURVIVORS STEERING COMMITTEE.—
p.001705: (i) REPRESENTATION.—The WTC Survivors Steer- ing Committee shall include representatives of—
p.001705: (I) the Centers of Excellence providing serv- ices to screening-eligible and certified-eligible WTC
p.001705: survivors;
p.001705: (II) the population of residents, students, and area and other workers affected by the September 11, 2001, terrorist
p.001705: attacks;
p.001705: (III) screening-eligible and certified-eligible survivors receiving initial health evaluations,
p.001705: monitoring, or treatment under part 2 of subtitle B and organizations advocating on their behalf; and
p.001705:
p.001705:
p.001705:
p.001705:
p.001705:
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p.001705:
p.001705:
p.001705:
p.001705:
p.001705:
p.001705: January 30, 2020
p.001705: (IV) New York City.
p.001705: (ii) INITIAL MEMBERSHIP.—The WTC Survivors Steering Committee shall initially be composed of
p.001705: members of the WTC Environmental Health Center Survivor Advisory Committee (as in existence on the day
p.001705: before the date of the enactment of this title).
p.001705: (C) ADDITIONAL APPOINTMENTS.—Each Steering Com- mittee may recommend, if approved by a majority of voting members
p.001705: of the Committee, additional members to the Committee.
p.001705: (D) VACANCIES.—A vacancy in a Steering Committee shall be filled by an individual recommended by the Steer- ing
p.001705: Committee.
p.001705: SEC. 3303. ø42 U.S.C. 300mm–2¿ EDUCATION AND OUTREACH.
p.001705: The WTC Program Administrator shall institute a program that provides education and outreach on the
p.001705: existence and avail- ability of services under the WTC Program. The outreach and edu- cation program—
p.001705: (1) shall include—
p.001705: (A) the establishment of a public Web site with infor- mation about the WTC Program;
p.001705: (B) meetings with potentially eligible populations;
p.001705: (C) development and dissemination of outreach mate- rials informing people about the program; and
p.001705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001705:
p.001705:
p.001705:
p.001705:
p.001705:
p.001705:
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p.001705: C:\XML\PHSA.BEL HOUSEP
p.001705:
p.001705:
p.001705: C:\XML\SSA-MERGED.XML
p.001705:
p.001705:
p.001707: 1707
p.001707: PUBLIC HEALTH SERVICE ACT
p.001707: Sec. 3305
p.001707:
p.001707: (D) the establishment of phone information services;
p.001707: and
p.001707: (2) shall be conducted in a manner intended—
p.001707: (A) to reach all affected populations; and
p.001707: (B) to include materials for culturally and linguis- tically diverse populations.
p.001707: SEC. 3304. ø42 U.S.C. 300mm–3¿ UNIFORM DATA COLLECTION AND ANALYSIS.
p.001707: (a) IN GENERAL.—The WTC Program Administrator shall pro- vide for the uniform collection of data,
p.001707: including claims data (and analysis of data and regular reports to the Administrator) on the prevalence of
p.001707: WTC-related health conditions and the identification of new WTC-related health conditions. Such data shall be collected
p.001707: for all individuals provided monitoring or treatment benefits under subtitle B and regardless of their place of
...

p.001707: tion.
p.001707: (D) TRANSPARENCY OF DATA.—A contract entered into under this subsection with a Data Center shall require the Data
p.001707: Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii)
p.001707: available to health researchers and others as provided in the CDC/ ATSDR Policy on Releasing and Sharing
p.001707: Data.
p.001707: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001707:
p.001707:
p.001707:
p.001707:
p.001707:
p.001707:
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p.001707:
p.001707:
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p.001707:
p.001707:
p.001709: 1709
p.001709: PUBLIC HEALTH SERVICE ACT
p.001709: Sec. 3305
p.001709:
p.001709: (3) AUTHORITY FOR CONTRACTS TO BE CLASS SPECIFIC.—A contract entered into under this subsection with a
p.001709: Clinical Center of Excellence or a Data Center may be with respect to one or more class of enrolled WTC
p.001709: responders, screening-eligi- ble WTC survivors, or certified-eligible WTC survivors.
p.001709: (4) USE OF COOPERATIVE AGREEMENTS.—Any contract under this title between the WTC Program Administrator and
p.001709: a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.
p.001709: (5) REVIEW ON FEASIBILITY OF CONSOLIDATING DATA CEN- TERS.—Not later than July 1, 2011, the Comptroller General
p.001709: of the United States shall submit to the Committee on Energy and Commerce of the House of
p.001709: Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate a report
p.001709: on the feasibility of consolidating Data Centers into a single Data Center.
p.001709: (b) CENTERS OF EXCELLENCE.—
p.001709: (1) CLINICAL CENTERS OF EXCELLENCE.—
p.001709: (A) DEFINITION.—For purposes of this title, the term ‘‘Clinical Center of Excellence’’ means a Center
p.001709: that dem- onstrates to the satisfaction of the Administrator that the Center—
p.001709: (i) uses an integrated, centralized health care pro- vider approach to create a comprehensive suite of
p.001709: health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC sur-
p.001709: vivors, or certified-eligible WTC survivors;
p.001709: (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes
p.001709: health care providers who have been trained pursuant to section 3313(c);
p.001709: (iii) employs health care provider staff with exper- tise that includes, at a minimum, occupational medi- cine,
p.001709: environmental medicine, trauma-related psychi- atry and psychology, and social services counseling; and
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709:
p.001709: January 30, 2020
p.001709: (iv) meets such other requirements as specified by the Administrator.
p.001709: (B) CONTRACT REQUIREMENTS.—The WTC Program Administrator shall not enter into a contract with a Clin-
p.001709: ical Center of Excellence under subsection (a)(1) unless the Center agrees to do each of the following:
...

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p.001711:
p.001711:
p.001711:
p.001711:
p.001711:
p.001711:
p.001711: January 30, 2020
p.001711: propriate and take into account the number of enrolled WTC responders receiving services from such Center
p.001711: under this title.
p.001711: (2) FIXED INFRASTRUCTURE COSTS.—For purposes of para- graph (1), the term ‘‘fixed infrastructure costs’’ means,
p.001711: with re- spect to a Clinical Center of Excellence, the costs incurred by such Center that are not
p.001711: otherwise reimbursable by the WTC Program Administrator under section 3312(c) for patient eval- uation,
p.001711: monitoring, or treatment but which are needed to oper- ate the WTC program such as the costs involved in
p.001711: outreach to participants or recruiting participants, data collection and analysis, social services for
p.001711: counseling patients on other avail- able assistance outside the WTC program, and the develop- ment of
p.001711: treatment protocols. Such term does not include costs for new construction or other capital costs.
p.001711: (d) GAO ANALYSIS.—Not later than July 1, 2011, the Comp- troller General shall submit to the Committee on
p.001711: Energy and Com- merce of the House of Representatives and the Committee on Health, Education, Labor, and
p.001711: Pensions of the Senate an analysis on whether Clinical Centers of Excellence with which the WTC Program
p.001711: Administrator enters into a contract under this section have financial systems that will allow for the timely
p.001711: submission of claims data for purposes of section 3304 and subsections (a)(1)(F) and (b)(1)(B)(iii).
p.001711: SEC. 3306. ø42 U.S.C. 300mm–5¿ DEFINITIONS.
p.001711: In this title:
p.001711: (1) The term ‘‘aggravating’’ means, with respect to a health condition, a health condition that existed on
p.001711: September 11, 2001, and that, as a result of exposure to airborne toxins, any other hazard, or any other adverse
p.001711: condition resulting from the September 11, 2001, terrorist attacks, requires medical treat- ment that is (or
p.001711: will be) in addition to, more frequent than, or of longer duration than the medical treatment that would have been
p.001711: required for such condition in the absence of such expo- sure.
p.001711: (2) The term ‘‘certified-eligible WTC survivor’’ has the meaning given such term in section 3321(a)(2).
p.001711: (3) The terms ‘‘Clinical Center of Excellence’’ and ‘‘Data Center’’ have the meanings given such terms
p.001711: in section 3305.
p.001711: (4) The term ‘‘enrolled WTC responder’’ means a WTC re- sponder enrolled under section 3311(a)(3).
p.001711: (5) The term ‘‘initial health evaluation’’ includes, with re- spect to an individual, a medical and exposure
p.001711: history, a phys- ical examination, and additional medical testing as needed to evaluate whether the individual
p.001711: has a WTC-related health con- dition and is eligible for treatment under the WTC Program.
...

p.001725: Administrator shall establish by regulation a re- imbursement rate for such treatment.
p.001725: (ii) EXCEPTION.—In no case shall payments for products or services under clause (i) be made at a rate higher than
p.001725: the Office of Worker’s Compensation Pro- grams in the Department Labor would pay for such products or
p.001725: services rendered at the time such prod- ucts or services were provided.
p.001725: (B) PHARMACEUTICALS.—
p.001725: (i) IN GENERAL.—The WTC Program Adminis- trator shall establish a program for paying for the
p.001725: medically necessary outpatient prescription pharma- ceuticals prescribed under this title for WTC-related
p.001725: health conditions through one or more contracts with outside vendors.
p.001725: (ii) COMPETITIVE BIDDING.—Under such program the Administrator shall—
p.001725: (I) select one or more appropriate vendors through a Federal competitive bid process; and
p.001725: (II) select the lowest bidder (or bidders) meet- ing the requirements for providing pharmaceutical benefits for
p.001725: participants in the WTC Program.
p.001725: (iii) TREATMENT OF FDNY PARTICIPANTS.—Under such program the Administrator may enter into an agreement
p.001725: with a separate vendor to provide pharma- ceutical benefits to enrolled WTC responders for whom the Clinical Center
p.001725: of Excellence is described in sec- tion 3305 if such an arrangement is deemed necessary and beneficial to the
p.001725: program by the WTC Program Administrator.
p.001725: (iv) PHARMACEUTICALS.—Not later than July 1, 2011, the Comptroller General of the United States shall
p.001725: submit to the Committee on Energy and Com- merce of the House of Representatives and the Com- mittee on
p.001725: Health, Education, Labor, and Pensions of the Senate a report on whether existing Federal phar- maceutical
p.001725: purchasing programs can provide pharma- ceutical benefits more efficiently and effectively than through the
p.001725: WTC program.
p.001725: (C) IMPROVING QUALITY AND EFFICIENCY THROUGH MODIFICATION OF PAYMENT AMOUNTS AND
p.001725: METHODOLO- GIES.—The WTC Program Administrator may modify the amounts and methodologies for making payments
p.001725: for ini- tial health evaluations, monitoring, or treatment, if, taking into account utilization and quality data
p.001725: furnished by the Clinical Centers of Excellence under section 3305(b)(1)(B)(iii), the
p.001725: Administrator determines that a bundling, capitation, pay for performance, or other pay- ment methodology
p.001725: would better ensure high quality and efficient delivery of initial health evaluations, monitoring, or
p.001725: treatment to an enrolled WTC responder, screening-eli- gible WTC survivor, or certified-eligible WTC survivor.
p.001725: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001725:
p.001725:
p.001725:
p.001725:
p.001725:
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p.001725:
p.001725:
p.001725: C:\XML\SSA-MERGED.XML
p.001725:
p.001725: Sec. 3313 PUBLIC HEALTH SERVICE ACT 1726
p.001725:
p.001725: (2) MONITORING AND INITIAL HEALTH EVALUATION.—The WTC Program Administrator shall reimburse the costs of mon-
p.001725: itoring and the costs of an initial health evaluation provided under this title at a rate set by the
p.001725: Administrator by regula- tion.
...

p.001725: (2) follow the monitoring, initial health evaluation, and treatment protocols developed under section
p.001725: 3305(a)(2)(A)(ii);
p.001725: (3) collect and report data in accordance with section 3304;
p.001725: and
p.001725: (4) meet such fraud, quality assurance, and other require-
p.001725:
p.001725:
p.001725:
p.001725:
p.001725: January 30, 2020
p.001725: ments as the WTC Program Administrator establishes, includ- ing sections 1128 through 1128E of the Social Security Act,
p.001725: as applied by section 3301(d).
p.001725: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001725:
p.001725:
p.001725:
p.001725:
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p.001725:
p.001725:
p.001727: 1727
p.001727: PUBLIC HEALTH SERVICE ACT
p.001727: Sec. 3321
p.001727:
p.001727: (c) TRAINING AND TECHNICAL ASSISTANCE.—The WTC Program Administer may provide, including through contract, for the
p.001727: provi- sion of training and technical assistance to health care providers participating in the network under
p.001727: subsection (a).
p.001727: (d) PROVISION OF SERVICES THROUGH THE VA.—
p.001727: (1) IN GENERAL.—The WTC Program Administrator may enter into an agreement with the Secretary of Veterans Affairs
p.001727: for the Secretary to provide services under this section through facilities of the Department of Veterans Affairs.
p.001727: (2) NATIONAL PROGRAM.—Not later than July 1, 2011, the Comptroller General of the United States shall
p.001727: submit to the Committee on Energy and Commerce of the House of Rep- resentatives and the Committee on
p.001727: Health, Education, Labor, and Pensions of the Senate a report on whether the Depart- ment of Veterans
p.001727: Affairs can provide monitoring and treatment services to individuals under this section more efficiently and
p.001727: effectively than through the nationwide network to be estab- lished under subsection (a).
p.001727: PART 2—WTC SURVIVORS
p.001727:
p.001727:
p.001727:
p.001727:
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p.001727:
p.001727:
p.001727: January 30, 2020
p.001727: SEC. 3321. ø42 U.S.C. 300mm–31¿ IDENTIFICATION AND INITIAL HEALTH EVALUATION OF SCREENING-ELIGIBLE AND CERTIFIED-
p.001727: ELIGIBLE WTC SURVIVORS.
p.001727: (a) IDENTIFICATION OF SCREENING-ELIGIBLE WTC SURVIVORS AND CERTIFIED-ELIGIBLE WTC SURVIVORS.—
p.001727: (1) SCREENING-ELIGIBLE WTC SURVIVORS.—
p.001727: (A) DEFINITION.—In this title, the term ‘‘screening-eli- gible WTC survivor’’ means, subject to subparagraph (C)
p.001727: and paragraph (3), an individual who is described in any of the following clauses:
p.001727: (i) CURRENTLY IDENTIFIED SURVIVOR.—An indi- vidual, including a WTC responder, who has been identified
p.001727: as eligible for medical treatment and moni- toring by the WTC Environmental Health Center as of the date of
p.001727: enactment of this title.
p.001727: (ii) SURVIVOR WHO MEETS CURRENT ELIGIBILITY CRITERIA.—An individual who is not a WTC responder, for purposes
p.001727: of the initial health evaluation under sub- section (b), claims symptoms of a WTC-related health condition and
...

p.001737: (A) for fiscal year 2016, the amount determined for such fiscal year under subparagraph (C) as in effect on the
p.001737: day before the date of enactment of the James Zadroga 9/ 11 Health and Compensation Reauthorization Act; and
p.001737: (B) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001737: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001737: United States city average) as estimated by the Secretary for the 12- month period ending with March of the
p.001737: previous year.
p.001737: (2) WTC HEALTH PROGRAM SCIENTIFIC/TECHNICAL ADVISORY COMMITTEE.—For the purpose of carrying out section 3302(a)—
p.001737: (A) for fiscal year 2016, $200,000; 1
p.001737: (B) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001737: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001737: United States
p.001737:
p.001737:
p.001737:
p.001737: January 30, 2020
p.001737: 1 So in law. Probably should read ‘‘; and’’.
p.001737:
p.001737: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001737:
p.001737:
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p.001737:
p.001739: 1739
p.001739: PUBLIC HEALTH SERVICE ACT
p.001739: Sec. 3351
p.001739:
p.001739: city average) as estimated by the Secretary for the 12- month period ending with March of the previous year.
p.001739: (3) EDUCATION AND OUTREACH.—For the purpose of car- rying out section 3303, for fiscal year 2016 and
p.001739: each subse- quent fiscal year, $750,000.
p.001739: (4) UNIFORM DATA COLLECTION.—For the purpose of car- rying out section 3304 and for reimbursing Data
p.001739: Centers (as defined in section 3305(b)(2)) for the costs incurred by such Centers in carrying out activities
p.001739: under contracts entered into under section 3305(a)(2)—
p.001739: (A) for fiscal year 2016, the amount determined for such fiscal year under subparagraph (C) as in effect on the
p.001739: day before the date of enactment of the James Zadroga 9/ 11 Health and Compensation Reauthorization Act;
p.001739: (B) for fiscal year 2017, $15,000,000; and
p.001739: (C) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001739: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001739: United States city average) as estimated by the Secretary for the 12- month period ending with March of the
p.001739: previous year.
p.001739: (5) RESEARCH REGARDING CERTAIN HEALTH CONDITIONS.— For the purpose of carrying out section 3341—
p.001739: (A) for fiscal year 2016, the amount determined for such fiscal year under subparagraph (C) as in effect on the
p.001739: day before the date of enactment of the James Zadroga 9/ 11 Health and Compensation Reauthorization Act; and
p.001739: (B) for each subsequent fiscal year, the amount speci- fied under this paragraph for the previous fiscal year
p.001739: in- creased by the percentage increase in the consumer price index for all urban consumers (all items;
p.001739: United States city average) as estimated by the Secretary for the 12- month period ending with March of the
p.001739: previous year.
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p.000001: (d) Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
p.000001: TRAINING OF OFFICERS
p.000001: SEC. 218. ø218a¿ (a) Appropriations available for the pay and allowances of commissioned officers of the
p.000001: Service shall also be available for the pay and allowances of any such officer on active
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 8 As a result of the amendments made by Public Law 104–299 (110 Stat. 3626), the Public Health Service
p.000001: Act no longer contained a section 329, 340, or 340A, and section 330 of such Act was substantially revised. Section
p.000001: 330 now includes provisions that relate to medically under- served populations, to migratory and seasonal
p.000001: agricultural workers, to homeless individuals, and to residents of public housing. Section 402 of Public Law 107–251
p.000001: (116 Stat. 1655) added a new section 340 that relates to a healthy communities access program.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 23 PUBLIC HEALTH SERVICE ACT Sec. 219
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p.000001: duty while attending any Federal or non-Federal educational insti- tution or training program and, subject to
p.000001: regulations of the Presi- dent and to the limitation prescribed in such appropriations, for payment of his
p.000001: tuition, fees, and other necessary expenses incident to such attendance.
p.000001: (b) Any officer whose tuition, fees, and other necessary ex- penses are paid pursuant to subsection (a) while
p.000001: attending an edu- cational institution or training program for a period in excess of thirty days shall be
p.000001: obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other
p.000001: necessary expenses received by such officer during such period, and two times the total amount of any
p.000001: compensation received by, and any allowance paid to, such officer during such period, if after re- turn
p.000001: to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the
p.000001: period of such attendance, whichever is greater. Such subsequent period of service shall com- mence upon the
p.000001: cessation of such attendance and of any further continuous period of training duty for which no tuition and fees
p.000001: are paid by the Service and which is part of the officer’s prescribed for- mal training program, whether such
p.000001: further training is at Service facility or otherwise. The Surgeon General may waive, in whole or in part, any
p.000001: payment which may be required by this subsection upon a determination that such payment would be
p.000001: inequitable or would not be in public interest.
p.000001: (c) A commissioned officer may be placed in leave without pay
p.000001: status while attending an educational institution or training pro- gram whenever the Secretary determines that
p.000001: such status is in the best interest of the Service. For purposes of computation of basic pay, promotion,
p.000001: retirement, compensation for injury or death, and the benefits provided by sections 212 and 224, an
p.000001: officer in such status pursuant to the preceding sentence shall be considered as performing service in
p.000001: the Service and shall have an active service obligation as set forth in subsection (b) of this section.
p.000001: ANNUAL AND SICK LEAVE
p.000001: SEC. 219. ø210–1¿ (a) In accordance with regulations of the President, commissioned officers of the
p.000001: Regular Corps and officers of the Reserve Corps on active duty may be granted annual leave and sick
p.000001: leave without any deductions from their pay and allow- ances: Provided, That such regulations shall not
p.000001: authorize annual leave to be accumulated in excess of sixty days.
p.000001: (d) 9 For purposes of this section the term ‘‘accumulated annual leave’’ means unused accrued annual leave
p.000001: carried forward from one leave year into a succeeding leave year, and the term ‘‘accrued annual leave’’ means the
p.000001: annual leave accruing to an officer during one leave year.
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p.000001: 9 Former subsection (b) was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Sec- tion 503(b) of title
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p.000017: Track faculty on a comparable basis with the employees of fully accredited schools of the health
p.000017: professions within the United States.
p.000017: (2) TITLES.—The Surgeon General may confer academic ti- tles, as appropriate, upon the members of the faculty.
p.000017: (3) NONAPPLICATION OF PROVISIONS.—The limitations in section 5373 of title 5, United States Code, shall
p.000017: not apply to the authority of the Surgeon General under paragraph (1) to prescribe salary schedules and
p.000017: other related benefits.
p.000017: (c) AGREEMENTS.—The Surgeon General may negotiate agree- ments with agencies of the Federal Government to utilize
p.000017: on a re- imbursable basis appropriate existing Federal medical resources lo- cated in the United States (or locations
p.000017: selected in accordance with section 271(a)(2)). Under such agreements the facilities concerned will retain
p.000017: their identities and basic missions. The Surgeon Gen- eral may negotiate affiliation agreements with
p.000017: accredited univer- sities and health professions training institutions in the United States. Such agreements
p.000017: may include provisions for payments for educational services provided students participating in Department of
p.000017: Health and Human Services educational programs.
p.000017: (d) PROGRAMS.—The Surgeon General may establish the fol- lowing educational programs for Track students:
p.000017: (1) Postdoctoral, postgraduate, and technological programs.
p.000017: (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students.
p.000017: (3) Other programs that the Surgeon General determines necessary in order to operate the Track in a
p.000017: cost-effective man- ner.
p.000017: (e) CONTINUING MEDICAL EDUCATION.—The Surgeon General shall establish programs in continuing medical education
p.000017: for mem- bers of the health professions to the end that high standards of health care may be maintained
p.000017: within the United States.
p.000017: (f) AUTHORITY OF THE SURGEON GENERAL.—
p.000017: (1) IN GENERAL.—The Surgeon General is authorized—
p.000017: (A) to enter into contracts with, accept grants from, and make grants to any nonprofit entity for the purpose
p.000017: of carrying out cooperative enterprises in medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, public health, and nursing research, consultation, and education;
p.000017: (B) to enter into contracts with entities under which the Surgeon General may furnish the services of such pro-
p.000017: fessional, technical, or clerical personnel as may be nec- essary to fulfill cooperative enterprises
p.000017: undertaken by the Track;
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p.000017: (V) to serve for a period of time (referred to in this part as the ‘‘period of obligated service’’) with- in the
p.000017: Commissioned Corps of the Public Health Service equal to 2 years for each school year dur- ing which such
p.000017: individual was enrolled at the Col- lege, reduced as provided for in paragraph (3);
p.000017: (B) a provision that any financial obligation of the United States arising out of a contract entered into under
p.000017: this part and any obligation of the student which is condi- tioned thereon, is contingent upon funds being
p.000017: appro- priated to carry out this part;
p.000017: (C) a statement of the damages to which the United States is entitled for the student’s breach of the
p.000017: contract; and
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p.000017: (D) such other statements of the rights and liabilities of the Secretary and of the individual, not
p.000017: inconsistent with the provisions of this part.
p.000017: (2) TUITION AND STUDENT STIPEND.—
p.000017: (A) TUITION REMISSION RATES.—The Surgeon General, based on the recommendations of the National Health Care
p.000017: Workforce Commission, shall establish Federal tui- tion remission rates to be used by the Track to provide re-
p.000017: imbursement to affiliated and other participating health professions institutions for the cost of educational
p.000017: services provided by such institutions to Track students. The agree- ment entered into by such participating
p.000017: institutions under paragraph (1)(A)(i) shall contain an agreement to accept as payment in full the established
p.000017: remission rate under this subparagraph.
p.000017: (B) STIPEND.—The Surgeon General, based on the rec- ommendations of the National Health Care Workforce
p.000017: Commission, shall establish and update Federal stipend rates for payment to students under this part.
p.000017: (3) REDUCTIONS IN THE PERIOD OF OBLIGATED SERVICE.— The period of obligated service under paragraph
p.000017: (1)(A)(ii)(V) shall be reduced—
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 274 PUBLIC HEALTH SERVICE ACT 72
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p.000017: meet certification, licensure or other requirements applicable to becoming a civil- ian health care professional
p.000017: (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse,
p.000017: physical therapy assistant, or physician assistant pro- fessions) in the State, develop or expand career pathways
p.000017: at in- stitutions of higher education to support veterans in meeting such requirements.
p.000017: (c) REPORT.—Upon the completion of the demonstration pro- gram under this section, the Secretary shall
p.000017: submit to Congress a report on the program.
p.000017: (d) FUNDING.—No additional funds are authorized to be appro- priated for the purpose of carrying out this
p.000017: section. This section shall be carried out using amounts otherwise available for such purpose.
p.000017: (e) SUNSET.—The demonstration program under this section shall not exceed 5 years.
p.000017: FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
p.000017: SEC. 316. 8 ø247a¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute
p.000017: of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the
p.000017: establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to
p.000017: assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of
p.000017: such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
p.000017: (1) university medical centers and other appropriate health care facilities which receive Federal funds from the
p.000017: Secretary and which conduct research on Alzheimer’s disease or provide services to individuals with such
p.000017: disease; and
p.000017: (2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
p.000017: (b) The Secretary shall promote the establishment of a national network to coordinate the family support groups
p.000017: described in sub- section (a).
p.000017: PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES
p.000017: SEC. 317. ø247b¿ (a) The Secretary may make grants to States, and in consultation with State health authorities,
p.000017: to political sub- divisions of States and to other public entities to assist them in
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p.000017: January 30, 2020
p.000017: 8 With respect to section 315, subsection (d) of such section provided as follows: ‘‘This section shall cease to exist
p.000017: on March 31, 1989.’’. See section 1 of Public Law 100–471 (102 Stat. 2284).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: of services, the requirement established in such paragraph regarding a participation agreement shall be waived by
p.000105: the Secretary if the provider does not, in providing health care services, impose a charge or accept
p.000105: reimbursement avail- able from any third-party payor, including reimbursement under any insurance policy or
p.000105: under any Federal or State health benefits plan.
p.000105: (B) A determination by the Secretary of whether a pro- vider referred to in subparagraph (A) meets the criteria for a
p.000105: waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary dona-
p.000105: tions regarding the provision of services to the public.
p.000105: (c) PRIORITY IN MAKING GRANTS.—In making grants under sub- section (a), the Secretary shall give priority to
p.000105: applications for pro- grams that will serve areas with a high incidence of elevated blood lead levels in infants and
p.000105: children.
p.000105: (d) GRANT APPLICATION.—No grant may be made under sub- section (a), unless an application therefor has
p.000105: been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be
p.000105: submitted in such manner as the Secretary shall prescribe and shall include each of the following:
p.000105: (1) A complete description of the program which is to be provided by or through the applicant.
p.000105: (2) Assurances satisfactory to the Secretary that the pro- gram to be provided under the grant applied
p.000105: for will include educational programs designed to—
p.000105: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: Sec. 317A PUBLIC HEALTH SERVICE ACT 106
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p.000105: (A) communicate to parents, educators, and local health officials the significance and prevalence of lead
p.000105: poi- soning in infants and children (including the sources of lead exposure, the importance of screening young
p.000105: children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which
p.000105: the program is designed to detect and prevent; and
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p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
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p.000121: LOAN REPAYMENT PROGRAM
p.000121: SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
p.000121: (1) AUTHORITY.—Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with
p.000121: appro- priately qualified health professionals under which such health professionals agree to conduct prevention
p.000121: activities or pre- paredness and response activities, including rapid response to public health
p.000121: emergencies and significant public health threats, as employees of the Centers for Disease Control
p.000121: and Prevention and the Agency for Toxic Substances and Disease
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000123: PUBLIC HEALTH SERVICE ACT
p.000123: Sec. 317H
p.000123:
p.000123: Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than
p.000123: $50,000 of the principal and interest of the educational loans of such health professionals.
p.000123: (2) LIMITATION.—The Secretary may not enter into an agreement with a health professional pursuant to
p.000123: paragraph
p.000123: (1) unless such professional—
p.000123: (A) has a substantial amount of educational loans rel- ative to income; and
p.000123: (B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for
p.000123: Toxic Substances and Disease Registry for purposes of para- graph (1) for a period of not less than 2 years.
p.000123: (b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan
p.000123: Repayment Program es- tablished in subpart III of part D of title III of this Act, the provi- sions of such
p.000123: subpart shall, except as inconsistent with subsection (a), apply to the program established in this
p.000123: section in the same manner and to the same extent as such provisions apply to the Na- tional Health Service Corps
p.000123: Loan Repayment Program.
p.000123: (c) AUTHORIZATION OF APPROPRIATIONS.—
p.000123: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, except as described in paragraph (2), there are
p.000123: authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each
p.000123: of the fiscal years 1995 through 2002.
p.000123: (2) EPIDEMIC INTELLIGENCE SERVICE PROGRAM.—For pur- poses of carrying out this section with respect to
p.000123: qualified health professionals serving in the Epidemic Intelligence Serv- ice, as authorized under section 317G, there
p.000123: is authorized to be appropriated $1,000,000 for each of fiscal years 2019 through 2023.
p.000123: (d) AVAILABILITY OF APPROPRIATIONS.—Amounts appropriated for a fiscal year for contracts under subsection
p.000123: (a) shall remain available until the expiration of the second fiscal year beginning after the fiscal year
p.000123: for which the amounts were appropriated.
p.000123: SEC. 317G. ø247b–8¿ FELLOWSHIP AND TRAINING PROGRAMS.
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p.000129: Control and Pre- vention, shall carry out programs—
p.000129: (1) to collect, analyze, and make available data on prenatal smoking and alcohol and other substance abuse and
p.000129: misuse, including—
p.000129: (A) data on—
p.000129: (i) the incidence, prevalence, and implications of such activities; and
p.000129: (ii) the incidence and prevalence of implications and outcomes, including neonatal abstinence syndrome and other
p.000129: maternal and child health outcomes associ- ated with such activities; and
p.000129: (B) additional information or data, as appropriate, on family health history, medication exposures during
p.000129: preg- nancy, demographic information, such as race, ethnicity, geographic location, and family history, and other
p.000129: relevant information, to inform such analysis;
p.000129: (2) to conduct applied epidemiological research on the pre- vention and long-term outcomes associated with
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and mis- use;
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p.000129: (3) to support, conduct, and evaluate the effectiveness of educational, treatment, and cessation programs;
p.000129: (4) to provide information and education to the public on the prevention and implications of
p.000129: prenatal and postnatal smoking, alcohol and other substance abuse and misuse; and
p.000129: (5) to issue public reports on the analysis of data described in paragraph (1), including analysis of—
p.000129: (A) long-term outcomes of children affected by neo- natal abstinence syndrome;
p.000129: (B) health outcomes associated with prenatal smoking, alcohol, and substance abuse and misuse; and
p.000129: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000131: PUBLIC HEALTH SERVICE ACT
p.000131: Sec. 317L–1
p.000131:
p.000131: (C) relevant studies, evaluations, or information the Secretary determines to be appropriate.
p.000131: (b) GRANTS.—In carrying out subsection (a), the Secretary may award grants to and enter into contracts with States,
p.000131: local govern- ments, tribal entities, scientific and academic institutions, federally qualified health centers, and
p.000131: other public and nonprofit entities, and may provide technical and consultative assistance to such enti- ties.
p.000131:
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p.000131: consultation (in- person or remotely) to aid in the treatment of pregnant and parenting women;
p.000131: (B) establishing linkages with and among community- based resources, including mental health resources, pri- mary
p.000131: care resources, and support groups; and
p.000131: (C) utilizing telehealth services for rural areas and medically underserved areas (as defined in
p.000131: section 330I(a)).
p.000131: (e) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $5,000,000
p.000131: for each of fiscal years 2018 through 2022.
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p.000131: January 30, 2020
p.000131: ORAL HEALTH PROMOTION AND DISEASE PREVENTION
p.000131: SEC. 317M. ø247b–14¿ (a) GRANTS TO INCREASE RESOURCES FOR COMMUNITY WATER FLUORIDATION.—
p.000131: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000131: may make grants to States and Indian tribes for the purpose of in- creasing the resources available for community
p.000131: water fluorida- tion.
p.000131: (2) USE OF FUNDS.—A State shall use amounts provided under a grant under paragraph (1)—
p.000131: (A) to purchase fluoridation equipment;
p.000131: (B) to train fluoridation engineers;
p.000131: (C) to develop educational materials on the benefits of fluoridation; or
p.000131: (D) to support the infrastructure necessary to monitor and maintain the quality of water fluoridation.
p.000131: (b) COMMUNITY WATER FLUORIDATION.—
p.000131: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention
p.000131: and in collaboration with the Director of the Indian Health Service, shall establish a demonstration
p.000131: project that is designed to as- sist rural water systems in successfully implementing the water
p.000131: fluoridation guidelines of the Centers for Disease Control and Prevention that are entitled ‘‘Engineering and
p.000131: Administra- tive Recommendations for Water Fluoridation, 1995’’ (referred to in this subsection as the
p.000131: ‘‘EARWF’’).
p.000131: (2) REQUIREMENTS.—
p.000131: (A) COLLABORATION.—In collaborating under para- graph (1), the Directors referred to in such paragraph shall
p.000131: ensure that technical assistance and training are provided
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000133: PUBLIC HEALTH SERVICE ACT
p.000133: Sec. 317M
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p.000137: PUBLIC HEALTH SERVICE ACT
p.000137: Sec. 317P
p.000137:
p.000137: HUMAN PAPILLOMAVIRUS (JOHANNA’S LAW 13)
p.000137: SEC. 317P. ø247b–17¿ (a) SURVEILLANCE.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall—
p.000137: (A) enter into cooperative agreements with States and other entities to conduct sentinel surveillance or other spe-
p.000137: cial studies that would determine the prevalence in var- ious age groups and populations of specific types of
p.000137: human papillomavirus (referred to in this section as ‘‘HPV’’) in dif- ferent sites in various regions of
p.000137: the United States, through collection of special specimens for HPV using a va- riety of laboratory-based testing
p.000137: and diagnostic tools; and
p.000137: (B) develop and analyze data from the HPV sentinel surveillance system described in subparagraph (A).
p.000137: (2) REPORT.—The Secretary shall make a progress report to the Congress with respect to paragraph (1) no
p.000137: later than 1 year after the effective date of this section.
p.000137: (b) PREVENTION ACTIVITIES; EDUCATION PROGRAM.—
p.000137: (1) IN GENERAL.—The Secretary, acting through the Cen- ters for Disease Control and Prevention, shall conduct
p.000137: preven- tion research on HPV, including—
p.000137: (A) behavioral and other research on the impact of HPV-related diagnosis on individuals;
p.000137: (B) formative research to assist with the development of educational messages and information for the public,
p.000137: for patients, and for their partners about HPV;
p.000137: (C) surveys of physician and public knowledge, atti- tudes, and practices about genital HPV infection; and
p.000137: (D) upon the completion of and based on the findings under subparagraphs (A) through (C), develop and
p.000137: dis- seminate educational materials for the public and health care providers regarding HPV and its impact
p.000137: and preven- tion.
p.000137: (2) REPORT; FINAL PROPOSAL.—The Secretary shall make a progress report to the Congress with respect to
p.000137: paragraph (1) not later than 1 year after the effective date of this section, and shall develop a final
p.000137: report not later than 3 years after such effective date, including a detailed summary of the signifi- cant
p.000137: findings and problems and the best strategies to prevent future infections, based on available science.
p.000137: (c) HPV EDUCATION AND PREVENTION.—
p.000137: (1) IN GENERAL.—The Secretary shall prepare and dis- tribute educational materials for health care providers and
p.000137: the public that include information on HPV. Such materials shall address—
p.000137: (A) modes of transmission;
p.000137: (B) consequences of infection, including the link be- tween HPV and cervical cancer;
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p.000137: January 30, 2020
p.000137: 13 The typeface and casing of the parenthetical matter in the section heading appears in law with all letter cased
p.000137: in lowercase and in bold face type; however, it is reflect here as it should appear in light face and all
p.000137: small caps.
p.000137: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000137: Sec. 317P PUBLIC HEALTH SERVICE ACT 138
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p.000137: (C) the available scientific evidence on the effective- ness or lack of effectiveness of condoms in
p.000137: preventing in- fection with HPV; and
p.000137: (D) the importance of regular Pap smears, and other diagnostics for early intervention and prevention of
p.000137: cer- vical cancer purposes in preventing cervical cancer.
p.000137: (2) MEDICALLY ACCURATE INFORMATION.—Educational ma- terial under paragraph (1), and all other relevant
p.000137: educational and prevention materials prepared and printed from this date forward for the public and health
p.000137: care providers by the Sec- retary (including materials prepared through the Food and Drug Administration,
p.000137: the Centers for Disease Control and Pre- vention, and the Health Resources and Services Administra- tion), or
p.000137: by contractors, grantees, or subgrantees thereof, that are specifically designed to address STDs including HPV
p.000137: shall contain medically accurate information regarding the effective- ness or lack of effectiveness of condoms in
p.000137: preventing the STD the materials are designed to address. Such requirement only applies to materials mass
p.000137: produced for the public and health care providers, and not to routine communications.
p.000137: (d) JOHANNA’S LAW.—
p.000137: (1) NATIONAL PUBLIC AWARENESS CAMPAIGN.—
p.000137: (A) IN GENERAL.—The Secretary shall carry out a na- tional campaign to increase the awareness and knowledge of
p.000137: health care providers and women with respect to gynecologic cancers.
p.000137: (B) WRITTEN MATERIALS.—Activities under the na- tional campaign under subparagraph (A) shall include—
p.000137: (i) maintaining a supply of written materials that provide information to the public on gynecologic can- cers;
p.000137: and
p.000137: (ii) distributing the materials to members of the public upon request.
p.000137: (C) PUBLIC SERVICE ANNOUNCEMENTS.—Activities under the national campaign under subparagraph
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p.000139: 3 months thereafter, submit to Congress an explanation as to why the Secretary has not yet complied
p.000139: with the first sentence of subparagraph (A), a detailed description of all actions undertaken within the
p.000139: month for which the report is being submitted to bring the Secretary into compliance with such sentence, and
p.000139: the anticipated date the Secretary expects to be in full compliance with such sentence.
p.000139: (4) CONSULTATION WITH NONPROFIT GYNECOLOGIC CANCER ORGANIZATIONS.—In carrying out the national campaign under this
p.000139: subsection, the Secretary shall consult with nonprofit gynecologic cancer organizations, with a
p.000139: mission both to con- quer ovarian or other gynecologic cancer and to provide out- reach to State and local
p.000139: governments and communities, for the purpose of determining the best practices for providing gynecologic
p.000139: cancer information and outreach services to varied populations.
p.000139: (6) 14 AUTHORIZATION OF APPROPRIATIONS.—For the pur- pose of carrying out this subsection, there is
p.000139: authorized to be appropriated $16,500,000 for the period of fiscal years 2007 through 2009 and $18,000,000
p.000139: for the period of fiscal years 2012 through 2014.
p.000139: SEC. 317Q. ø247b–18¿ SURVEILLANCE AND RESEARCH REGARDING MUSCULAR DYSTROPHY.
p.000139: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award
p.000139: grants and cooperative agreements to public or nonprofit private entities (including health departments of
p.000139: States and political subdivisions of States, and including universities and other educational entities) for the
p.000139: collection, analysis, and reporting of data on Duchenne and other forms of muscular dystrophy. In making such
p.000139: awards, the Secretary may provide direct technical assistance in lieu of cash.
p.000139: (b) NATIONAL MUSCULAR DYSTROPHY EPIDEMIOLOGY PRO- GRAM.—The Secretary, acting through the Director
p.000139: of the Centers for Disease Control and Prevention, may award grants to public or nonprofit private entities
p.000139: (including health departments of States and political subdivisions of States, and including universities and other
p.000139: educational entities) for the purpose of carrying out epidemio- logical activities regarding Duchenne and other
p.000139: forms of muscular dystrophies, including collecting and analyzing information on the number, incidence,
p.000139: correlates, and symptoms of cases. In carrying out the preceding sentence, the Secretary shall provide
p.000139: for a na- tional surveillance program and, to the extent possible, ensure that data be representative of all
p.000139: affected populations and shared in a timely manner. In making awards under this subsection, the Sec-
p.000139: retary may provide direct technical assistance in lieu of cash.
p.000139: (c) COORDINATION WITH CENTERS OF EXCELLENCE.—The Sec- retary shall ensure that epidemiological
p.000139: information under sub- sections (a) and (b) is made available to centers of excellence sup- ported under
p.000139: section 404E(b) by the Director of the National Insti- tutes of Health.
p.000139:
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p.000139: January 30, 2020
p.000139: 14 So in law. There is no paragraph (5).
p.000139:
p.000139: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000141: PUBLIC HEALTH SERVICE ACT
p.000141: Sec. 317S
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p.000141: (d) DATA.—In carrying out this section, the Secretary may en- sure that any data on patients that is collected
p.000141: as part of the Mus- cular Dystrophy STARnet (under a grant under this section) is reg- ularly updated to reflect
p.000141: changes in patient condition over time.
p.000141: (e) REPORTS AND STUDY.—
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p.000161: (I) providing a public method of communication for purposes of volunteer coordination (such as a
p.000161: phone number);
p.000161: (II) providing for optional registration to partici- pate in volunteer services during processes related
p.000161: to State medical licensing, registration, or certification or renewal of such licensing, registration, or
p.000161: certification; or
p.000161: (III) other mechanisms as the State determines appropriate;
p.000161: (v) a description of how the entity will include the State Unit on Aging in public health emergency pre-
p.000161: paredness;
p.000161: (vi) a description of how, as appropriate, the enti- ty may partner with relevant public and private stake- holders,
p.000161: including public health agencies with specific expertise that may be relevant to public health secu- rity,
p.000161: such as environmental health agencies, in public health emergency preparedness and response;
p.000161: (vii) a description of how, as applicable, such enti- ty may integrate information to account for individ- uals
p.000161: with behavioral health needs following a public health emergency;
p.000161: (viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency
p.000161: preparedness and response plans in public health emergency preparedness, including State educational
p.000161: agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965) and State child care lead
p.000161: agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);
p.000161: (ix) in the case of entities that operate on the United States-Mexico border or the United States-
p.000161: Canada border, a description of the activities such en- tity will carry out under the agreement that are spe-
p.000161: cific to the border area including disease detection, identification, investigation, and preparedness and re-
p.000161: sponse activities related to emerging diseases and in- fectious disease outbreaks whether naturally occurring
p.000161:
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p.000161: January 30, 2020
p.000161: 18 Margin for clause (iv) is so in law.
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p.000161: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 162
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p.000187: Sec. 319E PUBLIC HEALTH SERVICE ACT 188
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p.000187: (3) the epidemiology, mechanisms, and pathogenesis of antimicrobial resistance;
p.000187: (4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens
p.000187: (as deter- mined by the Director of the National Institutes of Health in consultation with the task
p.000187: force established under subsection (a)), in collaboration and coordination with the activities of the Department of
p.000187: Defense and the Joint Genome Institute of the Department of Energy; and
p.000187: (5) other relevant research areas.
p.000187: (c) EDUCATION OF MEDICAL AND PUBLIC HEALTH PERSONNEL.— The Secretary, after consultation with the Assistant
p.000187: Secretary for Health, the Surgeon General, the Director of the Centers for Dis- ease Control and
p.000187: Prevention, the Administrator of the Health Re- sources and Services Administration, the Director of the Agency
p.000187: for Healthcare Research and Quality, members of the task force de- scribed in subsection (a), professional
p.000187: organizations and societies, and such other public health officials as may be necessary, shall—
p.000187: (1) develop and implement educational programs to in- crease the awareness of the general public with respect to
p.000187: the public health threat of antimicrobial resistance and the appro- priate use of antibiotics;
p.000187: (2) develop and implement educational programs to in- struct health care professionals in the prudent use
p.000187: of anti- biotics; and
p.000187: (3) develop and implement programs to train laboratory personnel in the recognition or identification of
p.000187: resistance in pathogens.
p.000187: (d) GRANTS.—
p.000187: (1) IN GENERAL.—The Secretary shall award competitive grants to eligible entities to enable such entities to
p.000187: increase the capacity to detect, monitor, and combat antimicrobial resist- ance.
p.000187: (2) ELIGIBLE ENTITIES.—Eligible entities for grants under paragraph (1) shall be State or local public health
p.000187: agencies, In- dian tribes or tribal organizations, or other public or private nonprofit entities.
p.000187: (3) USE OF FUNDS.—An eligible entity receiving a grant under paragraph (1) shall use funds from such grant for
p.000187: activi- ties that are consistent with the factors identified by the task force under subsection (a)(3),
p.000187: which may include activities that—
p.000187: (A) provide training to enable such entity to identify patterns of resistance rapidly and accurately;
p.000187: (B) develop, improve, coordinate or enhance participa- tion in information systems by which data on resistant in-
p.000187: fections can be shared rapidly among relevant national, State, and local health agencies and health care
p.000187: providers; and
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p.000187: (C) develop and implement policies to control the spread of antimicrobial resistance.
p.000187: (e) GRANTS FOR DEMONSTRATION PROGRAMS.—
p.000187: (1) IN GENERAL.—The Secretary shall award competitive grants to eligible entities to establish demonstration
p.000187: programs
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p.000189: Secretary of Defense and the Sec- retary of Veterans Affairs, as appropriate and upon request.
p.000189: (g) REPORT ON ANTIMICROBIAL RESISTANCE IN HUMANS AND USE OF ANTIMICROBIAL DRUGS.—Not later than 1
p.000189: year after the date of enactment of the 21st Century Cures Act, and annually thereafter, the Secretary
p.000189: shall prepare and make publicly available data and information concerning—
p.000189: (1) aggregate national and regional trends of antimicrobial resistance in humans to antimicrobial drugs,
p.000189: including such drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act;
p.000189: (2) antimicrobial stewardship, which may include sum- maries of State efforts to address antimicrobial
p.000189: resistance in humans to antimicrobial drugs and antimicrobial stewardship; and
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p.000189: (3) coordination between the Director of the Centers for Disease Control and Prevention and the Commissioner of
p.000189: Food and Drugs with respect to the monitoring of—
p.000189: (A) any applicable resistance under paragraph (1); and
p.000189: (B) drugs approved under section 506(h) of the Federal Food, Drug, and Cosmetic Act.
p.000189: (h) INFORMATION RELATED TO ANTIMICROBIAL STEWARDSHIP PROGRAMS.—The Secretary shall, as appropriate,
p.000189: disseminate guid- ance, educational materials, or other appropriate materials related to the development and
p.000189: implementation of evidence-based anti- microbial stewardship programs or practices at health care facili-
p.000189: ties, such as nursing homes and other long-term care facilities, am- bulatory surgical centers, dialysis centers,
p.000189: outpatient clinics, and hospitals, including community and rural hospitals.
p.000189: (i) SUPPORTING STATE-BASED ACTIVITIES TO COMBAT ANTI- MICROBIAL RESISTANCE.—The Secretary shall
p.000189: continue to work with State and local public health departments on statewide or regional programs related to
p.000189: antimicrobial resistance. Such efforts may in- clude activities to related to—
p.000189: (1) identifying patterns of bacterial and fungal resistance in humans to antimicrobial drugs;
p.000189: (2) preventing the spread of bacterial and fungal infections that are resistant to antimicrobial drugs; and
p.000189: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000189: Sec. 319F PUBLIC HEALTH SERVICE ACT 190
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p.000191: PUBLIC HEALTH SERVICE ACT
p.000191: Sec. 319F
p.000191:
p.000191: (E) protecting health care workers and health care first responders from workplace exposures during a public
p.000191: health emergency.
p.000191: (3) PEER REVIEW.—On a periodic basis, products prepared as part of the program shall be rigorously
p.000191: tested and peer-re- viewed by experts in the relevant fields.
p.000191: (4) CREDIT.—The Secretary and the Secretary of Defense shall—
p.000191: (A) take into account continuing professional education requirements of public health and healthcare professions;
p.000191: and
p.000191: (B) cooperate with State, local, and tribal accrediting agencies and with professional associations in
p.000191: arranging for students enrolled in the program to obtain continuing professional education credit for program
p.000191: courses.
p.000191: (5) DISSEMINATION AND TRAINING.—
p.000191: (A) IN GENERAL.—The Secretary may provide for the dissemination and teaching of the materials described
p.000191: in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary.
p.000191: (B) CERTAIN ENTITIES.—The education and training ac- tivities described in subparagraph (A) may be carried out
p.000191: by Federal public health, medical, or dental entities, ap- propriate educational entities, professional
p.000191: organizations and societies, private accrediting organizations, and other nonprofit institutions or entities
p.000191: meeting criteria estab- lished by the Secretary.
p.000191: (C) GRANTS AND CONTRACTS.—In carrying out this sub- section, the Secretary may carry out activities directly or
p.000191: through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
p.000191: (b) ADVICE TO THE FEDERAL GOVERNMENT.—
p.000191: (1) REQUIRED ADVISORY COMMITTEES.—In coordination with the working group under subsection (a), the
p.000191: Secretary shall establish advisory committees in accordance with para- graphs (2) and (3) to provide expert
p.000191: recommendations to assist such working groups in carrying out their respective respon- sibilities under
p.000191: subsections (a) and (b) 19.
p.000191: (2) NATIONAL ADVISORY COMMITTEE ON CHILDREN AND TER- RORISM 20.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the National Advisory Committee on At-Risk In- dividuals and Public Health Emergencies (referred
p.000191: to in this paragraph as the ‘‘Advisory Committee’’).
p.000191:
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p.000191: January 30, 2020
p.000191: 19 Probably should be ‘‘to assist such working group in carrying out its responsibilities under subsection (a)’’.
p.000191: Formerly there were two working groups, one under subsection (a) and one under subsection (b). Now there is
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p.000231: payments.
p.000231: (e) SUPPLEMENT NOT SUPPLANT.—Grants under subsection (a) shall be used to supplement, and not supplant,
p.000231: other Federal, State, or local public funds provided for the activities described in such subsection.
p.000231: (f) GENERAL ACCOUNTING OFFICE REPORT 24.—Not later than 180 days after the conclusion of the
p.000231: demonstration programs car- ried out under subsection (a), the Comptroller General of the United States
p.000231: shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of
p.000231: the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of
p.000231: Representatives, a report that de- scribes the ability of grantees under such subsection to detect
p.000231: pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such
p.000231: threats, and train personnel involved with the various responsibilities and capabilities needed to deal with
p.000231: bioterrorist threats.
p.000231: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000231: $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006.
p.000231: SEC. 319H. ø247d–7a¿ GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH PROFESSIONALS.
p.000231: (a) IN GENERAL.—The Secretary may make awards of grants and cooperative agreements to appropriate public
p.000231: and nonprofit private health or educational entities, including health professions schools and programs as
p.000231: defined in section 799B, for the purpose of providing low-interest loans, partial scholarships, partial fellow-
p.000231: ships, revolving loan funds, or other cost-sharing forms of assist- ance for the education and training
p.000231: of individuals in any category of health professions for which there is a shortage that the Sec- retary
p.000231: determines should be alleviated in order to prepare for or re- spond effectively to bioterrorism and other public
p.000231: health emer- gencies.
p.000231: (b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.— The Secretary may require as a condition of an
p.000231: award under sub- section (a) that a grantee under such subsection provide non-Fed- eral contributions toward
p.000231: the purpose described in such subsection.
p.000231: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000231: to be appropriated
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p.000231: 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814).
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: PUBLIC HEALTH SERVICE ACT
p.000233: Sec. 319I
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p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
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p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
p.000259: (v) education of patients and the general popu- lation served by the health center regarding the avail- ability
p.000259: and proper use of health services.
p.000259: (B) EXCEPTION.—With respect to a health center that receives a grant only under subsection (g), the
p.000259: Secretary, upon a showing of good cause, shall—
p.000259: (i) waive the requirement that the center provide all required primary health services under this para-
p.000259: graph; and
p.000259: (ii) approve, as appropriate, the provision of cer- tain required primary health services only during cer- tain
p.000259: periods of the year.
p.000259: (2) ADDITIONAL HEALTH SERVICES.—The term ‘‘additional health services’’ means services that are not
p.000259: included as re- quired primary health services and that are appropriate to meet the health needs of the
p.000259: population served by the health center involved. Such term may include—
p.000259: (A) behavioral and mental health and substance use disorder services;
p.000259: (B) recuperative care services;
p.000259: (C) environmental health services, including—
...

p.000283: SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
p.000283: (a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
p.000283: (1) IN GENERAL.—The Secretary shall develop and imple- ment public health surveillance, education, research, and
p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
p.000283: targeted to parents, schools, daycare providers, patients;
p.000283: (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig-
p.000283: mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth;
p.000283: (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and
p.000283: related needs of people with disabilities; and
p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000283:
p.000283: (3) COORDINATION OF ACTIVITIES.—The Secretary shall en- sure that activities under this subsection are
p.000283: coordinated as appropriate with other agencies of the Public Health Service that carry out activities
p.000283: regarding epilepsy and seizure.
...

p.000297: Code of 1986 and exempt from tax under section 501(a) of such Code; and
p.000297: (2) submit an application to the Secretary at such time, in such manner, and containing such information as the
p.000297: Sec- retary may require.
p.000297: (c) USE OF FUNDS.—An entity—
p.000297: (1) shall use amounts received through a grant under sub- section (a) to—
p.000297: (A) train emergency medical services personnel as ap- propriate to obtain and maintain licenses and certifications
p.000297: relevant to service in an emergency medical services agen- cy described in subsection (b)(1);
p.000297: (B) conduct courses that qualify graduates to serve in an emergency medical services agency described in
p.000297: sub- section (b)(1) in accordance with State and local require- ments;
p.000297: (C) fund specific training to meet Federal or State li- censing or certification requirements; and
p.000297: (D) acquire emergency medical services equipment;
p.000297:
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p.000297: January 30, 2020
p.000297: and
p.000297: (2) may use amounts received through a grant under sub- section (a) to—
p.000297: (A) recruit and retain emergency medical services per- sonnel, which may include volunteer personnel;
p.000297: (B) develop new ways to educate emergency health care providers through the use of
p.000297: technology-enhanced educational methods; or
p.000297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000297: Sec. 330K PUBLIC HEALTH SERVICE ACT 298
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p.000297: (C) acquire personal protective equipment for emer- gency medical services personnel as required by the Occu-
p.000297: pational Safety and Health Administration.
p.000297: (d) GRANT AMOUNTS.—Each grant awarded under this section shall be in an amount not to exceed $200,000.
p.000297: (e) DEFINITIONS.—In this section:
p.000297: (1) The term ‘‘emergency medical services’’—
p.000297: (A) means resources used by a public or private non- profit licensed entity to deliver medical care
p.000297: outside of a medical facility under emergency conditions that occur as a result of the condition of the
p.000297: patient; and
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p.000317: January 30, 2020
p.000317:
p.000317: tity a Corps member who has (and whose spouse, if any, has) char- acteristics that increase the probability that
p.000317: the member will re- main in the health professional shortage area involved after the completion of the
p.000317: period of service in the Corps.
p.000317: (b) COUNSELING ON SERVICE IN CORPS.—
p.000317: (1) IN GENERAL.—The Secretary shall, subject to paragraph (3), offer appropriate counseling on service in the Corps to
p.000317: indi- viduals during the period of membership in the Corps, particu- larly during the initial period of each
p.000317: assignment.
p.000317: (2) CAREER ADVISOR REGARDING OBLIGATED SERVICE.—
p.000317: (A) In the case of individuals who have entered into contracts for obligated service under the
p.000317: Scholarship or Loan Repayment Program, counseling under paragraph (1) shall include appropriate counseling on matters
p.000317: particular to such obligated service. The Secretary shall ensure that career advisors for providing such
p.000317: counseling are available to such individuals throughout the period of participation in the Scholarship or Loan
p.000317: Repayment Program.
p.000317: (B) With respect to the Scholarship Program, coun- seling under paragraph (1) shall include counseling
p.000317: indi- viduals during the period in which the individuals are pur- suing an educational degree in the health
p.000317: profession in- volved, including counseling to prepare the individual for service in the Corps.
p.000317: (3) EXTENT OF COUNSELING SERVICES.—With respect to in- dividuals who have entered into contracts for obligated
p.000317: service under the Scholarship or Loan Repayment Program, this sub- section shall be carried out
p.000317: regarding such individuals throughout the period of obligated service (and, additionally, throughout the
p.000317: period specified in paragraph (2)(B), in the case of the Scholarship Program). With respect to Corps members
p.000317: generally, this subsection shall be carried out to the extent practicable.
p.000317: (c) GRANTS REGARDING PREPARATION OF STUDENTS FOR PRAC- TICE.—With respect to individuals who have entered into
p.000317: contracts for obligated service under the Scholarship or Loan Repayment Program, the Secretary may make
p.000317: grants to, and enter into con- tracts with, public and nonprofit private entities (including health
p.000317: professions schools) for the conduct of programs designed to pre- pare such individuals for the effective
p.000317: provision of primary health services in the health professional shortage areas to which the indi- viduals are
p.000317: assigned.
p.000317: (d) PROFESSIONAL DEVELOPMENT AND TRAINING.—
p.000317: (1) IN GENERAL.—The Secretary shall assist Corps mem- bers in establishing and maintaining professional
p.000317: relationships and development opportunities, including by—
p.000317: (A) establishing appropriate professional relationships between the Corps member involved and the health profes-
p.000317: sions community of the geographic area with respect to which the member is assigned;
p.000317: (B) establishing professional development, training, and mentorship linkages between the Corps member
p.000317: in- volved and the larger health professions community, in- cluding through distance learning, direct
p.000317: mentorship, and
p.000317: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000319: PUBLIC HEALTH SERVICE ACT
p.000319: Sec. 336
p.000319:
p.000319: development and implementation of training modules de- signed to meet the educational needs of offsite Corps mem-
p.000319: bers;
p.000319: (C) establishing professional networks among Corps members; or
p.000319: (D) engaging in other professional development, mentorship, and training activities for Corps
p.000319: members, at the discretion of the Secretary.
p.000319: (2) ASSISTANCE IN ESTABLISHING PROFESSIONAL RELATION- SHIPS.—In providing such assistance under paragraph
p.000319: (1), the Secretary shall focus on establishing relationships with hos- pitals, with academic medical
p.000319: centers and health professions schools, with area health education centers under section 751, with health
p.000319: education and training centers under section 752, and with border health education and training centers
p.000319: under such section 752. Such assistance shall include assistance in obtaining faculty appointments at health
p.000319: professions schools.
p.000319: (3) SUPPLEMENT NOT SUPPLANT.—Such efforts under this subsection shall supplement, not supplant, non-government
p.000319: ef- forts by professional health provider societies to establish and maintain professional relationships and
p.000319: development opportu- nities.
p.000319: (e) TEMPORARY RELIEF FROM CORPS DUTIES.—
p.000319: (1) IN GENERAL.—The Secretary shall, subject to paragraph (4), provide assistance to Corps members in
p.000319: establishing ar- rangements through which Corps members may, as appro- priate, be provided temporary relief
...

p.000321: (a) for any fiscal year may be made at any time before that fiscal year and may be included in an Act
p.000321: making an appropriation under an authorization under subsection (a) for another fiscal year; but no funds
p.000321: may be made available from any appropriation under such authorization for obligation under sections 331
p.000321: through 335, section 336A, and section 337 before the fiscal year for which such appropriation is authorized.
p.000321:
p.000321: Subpart III—Scholarship Program and Loan Repayment Program
p.000321:
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p.000321: January 30, 2020
p.000321: NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP PROGRAM
p.000321: SEC. 338A. ø254l¿ (a) The Secretary shall establish the Na- tional Health Service Corps Scholarship
p.000321: Program to assure, with respect to the provision of primary health services pursuant to sec- tion 331(a)(2)—
p.000321: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000321: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000321: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000321: (b) To be eligible to participate in the Scholarship Program, an individual must—
p.000321: (1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by
p.000321: the Secretary) educational institution in a State and (B) in a course of study or program, offered by
p.000321: such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medi- cine,
p.000321: dentistry, or other health profession, or an appropriate degree from a graduate program of behavioral and
p.000321: mental health;
p.000321: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000321: Corps of the Service or be eligible for selection for civilian service in the Corps;
p.000321: (3) submit an application to participate in the Scholarship Program; and
p.000321: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000323: PUBLIC HEALTH SERVICE ACT
p.000323: Sec. 338A
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p.000323: (f) The written contract (referred to in this subpart) between the Secretary and an individual shall contain—
p.000323: (1) an agreement that—
p.000323: (A) subject to paragraph (2), the Secretary agrees (i) to provide the individual with a scholarship (described
p.000323: in subsection (g)) in each such school year or years for a pe- riod of years (not to exceed four
p.000323: school years) determined by the individual, during which period the individual is pursuing a course of
p.000323: study described in subsection (b)(1)(B), and (ii) to accept (subject to the availability of ap- propriated funds
p.000323: for carrying out sections 331 through 335 and section 337) the individual into the Corps (or for equivalent
p.000323: service as otherwise provided in this subpart); and
p.000323:
p.000323:
p.000323: January 30, 2020
p.000323: (B) subject to paragraph (2), the individual agrees—
p.000323: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000325: PUBLIC HEALTH SERVICE ACT
p.000325: Sec. 338A
p.000325:
p.000325: (i) to accept provision of such a scholarship to the individual;
p.000325: (ii) to maintain enrollment in a course of study de- scribed in subsection (b)(1)(B) until the individual
p.000325: completes the course of study;
p.000325: (iii) while enrolled in such course of study, to maintain an acceptable level of academic standing (as
p.000325: determined under regulations of the Secretary by the educational institution offering such course of
p.000325: study);
p.000325: (iv) if pursuing a degree from a school of medicine or osteopathic medicine, to complete a residency in a
p.000325: specialty that the Secretary determines is consistent with the needs of the Corps; and
p.000325: (v) to serve for a time period (hereinafter in the subpart referred to as the ‘‘period of obligated service’’)
p.000325: equal to—
p.000325: (I) one year for each school year for which the individual was provided a scholarship under the Scholarship
p.000325: Program, or
p.000325: (II) two years,
p.000325: whichever is greater, as a provider of primary health services in a health professional shortage area
p.000325: (des- ignated under section 332) to which he is assigned by the Secretary as a member of the Corps, or as
p.000325: other- wise provided in this subpart;
p.000325: (2) a provision that any financial obligation of the United States arising out of a contract entered into
p.000325: under this subpart and any obligation of the individual which is conditioned there- on, is contingent upon funds
p.000325: being appropriated for scholar- ships under this subpart and to carry out the purposes of sec- tions 331 through 335
p.000325: and sections 337 and 338;
p.000325: (3) a statement of the damages to which the United States is entitled, under section 338E for the individual’s
p.000325: breach of the contract; and
p.000325: (4) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with
p.000325: the pro- visions of this subpart.
p.000325: (g)(1) A scholarship provided to a student for a school year under a written contract under the Scholarship
p.000325: Program shall con- sist of—
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p.000325: (A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the amount (except as
p.000325: provided in sec- tion 711) of—
p.000325: (i) the tuition of the student in such school year; and
p.000325: (ii) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred
p.000325: by the student in such school year; and
p.000325: (B) payment to the student of a stipend of $400 per month (adjusted in accordance with paragraph (3)) for each of the
p.000325: 12 consecutive months beginning with the first month of such school year.
p.000325: (2) The Secretary may contract with an educational institution, in which a participant in the Scholarship
p.000325: Program is enrolled, for the payment to the educational institution of the amounts of tui-
p.000325: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000325: Sec. 338B PUBLIC HEALTH SERVICE ACT 326
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p.000325: tion and other reasonable educational expenses described in para- graph (1)(A). Payment to such an
p.000325: educational institution may be made without regard to section 3648 of the Revised Statutes (31
p.000325: U.S.C. 529).
p.000325: (3) The amount of the monthly stipend, specified in paragraph (1)(B) and as previously adjusted (if at all) in
p.000325: accordance with this paragraph, shall be increased by the Secretary for each school year ending in a fiscal year
p.000325: beginning after September 30, 1978, by an amount (rounded to the next highest multiple of $1) equal to
p.000325: the amount of such stipend multiplied by the overall percentage (under section 5303 of title 5, United States
p.000325: Code) of the adjustment (if such adjustment is an increase) in the rates of pay under the Gen- eral Schedule made
p.000325: effective in the fiscal year in which such school year ends.
p.000325: (h) Notwithstanding any other provision of law, individuals who have entered into written contracts with
p.000325: the Secretary under this section, while undergoing academic training, shall not be counted against
p.000325: any employment ceiling affecting the Department.
p.000325: SEC. 338B. ø254l–1¿ NATIONAL HEALTH SERVICE CORPS LOAN REPAY- MENT PROGRAM.
p.000325: (a) ESTABLISHMENT.—The Secretary shall establish a program to be known as the National Health Service Corps
p.000325: Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to section
p.000325: 331(a)(2)—
p.000325: (1) an adequate supply of physicians, dentists, behavioral and mental health professionals, certified nurse
p.000325: midwives, cer- tified nurse practitioners, and physician assistants; and
p.000325: (2) if needed by the Corps, an adequate supply of other health professionals.
p.000325: (b) ELIGIBILITY.—To be eligible to participate in the Loan Re- payment Program, an individual must—
p.000325: (1)(A) have a degree in medicine, osteopathic medicine, dentistry, or another health profession, or an
p.000325: appropriate de- gree from a graduate program of behavioral and mental health, or be certified as a nurse midwife,
p.000325: nurse practitioner, or physi- cian assistant;
p.000325: (B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry,
p.000325: behavioral and mental health, or other health profession; or
p.000325: (C) be enrolled as a full-time student—
p.000325: (i) in an accredited (as determined by the Secretary) educational institution in a State; and
p.000325: (ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary,
p.000325: leading to a degree in medicine, osteopathic medicine, den- tistry, or other health profession;
p.000325: (2) be eligible for, or hold, an appointment as a commis- sioned officer in the Regular or Reserve
p.000325: Corps of the Service or be eligible for selection for civilian service in the Corps; and
p.000325: (3) submit to the Secretary an application for a contract described in subsection (f) (relating to the payment
p.000325: by the Sec- retary of the educational loans of the individual in consider- ation of the individual serving for
p.000325: a period of obligated service).
p.000325: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000327: 327
p.000327: PUBLIC HEALTH SERVICE ACT
p.000327: Sec. 338B
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p.000327: January 30, 2020
p.000327: (c) APPLICATION, CONTRACT, AND INFORMATION REQUIRE-
p.000327: MENTS.—
p.000327: (1) SUMMARY AND INFORMATION.—In disseminating appli- cation forms and contract forms to individuals desiring to
p.000327: par- ticipate in the Loan Repayment Program, the Secretary shall include with such forms—
p.000327: (A) a fair summary of the rights and liabilities of an individual whose application is approved (and
p.000327: whose con- tract is accepted) by the Secretary, including in the sum- mary a clear explanation of the
p.000327: damages to which the United States is entitled under section 338E in the case of the individual’s breach of the
...

p.000327: (i) to accept loan payments on behalf of the indi- vidual;
p.000327: (ii) in the case of an individual described in sub- section (b)(1)(C), to maintain enrollment in a course of
p.000327: study or training described in such subsection until the individual completes the course of study or
p.000327: train- ing;
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p.000327: January 30, 2020
p.000327: (iii) in the case of an individual described in sub- section (b)(1)(C), while enrolled in such course of study
p.000327: or training, to maintain an acceptable level of aca-
p.000327: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000329: 329
p.000329: PUBLIC HEALTH SERVICE ACT
p.000329: Sec. 338B
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p.000329: demic standing (as determined under regulations of the Secretary by the educational institution offering
p.000329: such course of study or training); and
p.000329: (iv) to serve for a time period (hereinafter in this subpart referred to as the ‘‘period of obligated
p.000329: service’’) equal to 2 years or such longer period as the indi- vidual may agree to, as a provider of
p.000329: primary health services in a health professional shortage area (des- ignated under section 332) to which such
p.000329: individual is assigned by the Secretary as a member of the Corps or released under section 338D;
p.000329: (2) a provision permitting the Secretary to extend for such longer additional periods, as the individual may
p.000329: agree to, the period of obligated service agreed to by the individual under paragraph (1)(B)(iv),
p.000329: including extensions resulting in an ag- gregate period of obligated service in excess of 4 years;
p.000329: (3) a provision that any financial obligation of the United States arising out of a contract entered into
p.000329: under this subpart and any obligation of the individual that is conditioned there- on, is contingent on
p.000329: funds being appropriated for loan repay- ments under this subpart and to carry out the purposes of sec- tions 331
p.000329: through 335 and sections 337 and 338;
p.000329: (4) a statement of the damages to which the United States is entitled, under section 338E for the individual’s
p.000329: breach of the contract; and
p.000329: (5) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with
p.000329: this sub- part.
p.000329: (g) PAYMENTS.—
p.000329: (1) IN GENERAL.—A loan repayment provided for an indi- vidual under a written contract under the Loan
p.000329: Repayment Program shall consist of payment, in accordance with para- graph (2), on behalf of the individual of
p.000329: the principal, interest, and related expenses on government and commercial loans re- ceived by the individual regarding
p.000329: the undergraduate or grad- uate education of the individual (or both), which loans were made for—
p.000329: (A) tuition expenses;
p.000329: (B) all other reasonable educational expenses, includ- ing fees, books, and laboratory expenses, incurred
p.000329: by the individual; or
p.000329: (C) reasonable living expenses as determined by the Secretary.
p.000329: (2) PAYMENTS FOR YEARS SERVED.—
p.000329: (A) IN GENERAL.—For each year of obligated service that an individual contracts to serve under subsection
p.000329: (f) the Secretary may pay up to $50,000, plus, beginning with fiscal year 2012, an amount determined by the
p.000329: Secretary on an annual basis to reflect inflation, on behalf of the in- dividual for loans described in paragraph (1).
p.000329: In making a determination of the amount to pay for a year of such serv- ice by an individual, the Secretary shall
p.000329: consider the ex- tent to which each such determination—
p.000329: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000329: Sec. 338C PUBLIC HEALTH SERVICE ACT 330
p.000329:
p.000329: (i) affects the ability of the Secretary to maximize the number of contracts that can be provided under the
p.000329: Loan Repayment Program from the amounts ap- propriated for such contracts;
p.000329: (ii) provides an incentive to serve in health profes- sional shortage areas with the greatest such short- ages;
p.000329: and
p.000329: (iii) provides an incentive with respect to the health professional involved remaining in a health
p.000329: professional shortage area, and continuing to provide primary health services, after the completion of the
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p.000333: Sec. 338E PUBLIC HEALTH SERVICE ACT 334
p.000333:
p.000333: under this section the cost of such individual’s malpractice insur- ance and the lesser of—
p.000333: (1)(A) $10,000 in the first year of obligated service;
p.000333: (B) $7,500 in the second year of obligated service;
p.000333: (C) $5,000 in the third year of obligated service; and
p.000333: (D) $2,500 in the fourth year of obligated service; or
p.000333: (2) an amount determined by subtracting such individual’s net income before taxes from the income the
p.000333: individual would have received as a member of the Corps for each such year of obligated service.
p.000333: (g) The Secretary shall, upon request, provide to each indi- vidual released from service obligation under
p.000333: this section technical assistance to assist such individual in fulfilling his or her agree- ment under this
p.000333: section.
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p.000333: January 30, 2020
p.000333: BREACH OF SCHOLARSHIP CONTRACT OR LOAN REPAYMENT CONTRACT
p.000333: SEC. 338E. ø254o¿ (a)(1) An individual who has entered into a written contract with the Secretary under section 338A
p.000333: and who—
p.000333: (A) fails to maintain an acceptable level of academic stand- ing in the educational institution in which he is enrolled
p.000333: (such level determined by the educational institution under regula- tions of the Secretary);
p.000333: (B) is dismissed from such educational institution for dis- ciplinary reasons; or
p.000333: (C) voluntarily terminates the training in such an edu- cational institution for which he is provided a
p.000333: scholarship under such contract, before the completion of such training,
p.000333: in lieu of any service obligation arising under such contract, shall be liable to the United States for the
p.000333: amount which has been paid to him, or on his behalf, under the contract.
p.000333: (2) An individual who has entered into a written contract with the Secretary under section 338B and who—
p.000333: (A) in the case of an individual who is enrolled in the final year of a course of study, fails to maintain an
p.000333: acceptable level of academic standing in the educational institution in which such individual is enrolled
p.000333: (such level determined by the edu- cational institution under regulations of the Secretary) or vol-
p.000333: untarily terminates such enrollment or is dismissed from such educational institution before completion of
p.000333: such course of study; or
p.000333: (B) in the case of an individual who is enrolled in a grad- uate training program, fails to complete such training
p.000333: program and does not receive a waiver from the Secretary under section 338B(b)(1)(B)(ii),
p.000333: in lieu of any service obligation arising under such contract shall be liable to the United States for
p.000333: the amount that has been paid on behalf of the individual under the contract.
p.000333: (b)(1)(A) Except as provided in paragraph (2), if (for any reason not specified in subsection (a) or section
p.000333: 338G(d)) an individual breaches his written contract by failing to begin such individual’s service
p.000333: obligation under section 338A in accordance with section 338C or 338D, to complete such service
p.000333: obligation, or to complete a required residency as specified in section 338A(f)(1)(B)(iv), the
p.000333: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000335: PUBLIC HEALTH SERVICE ACT
p.000335: Sec. 338E
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p.000335: United States shall be entitled to recover from the individual an amount determined in accordance with the
p.000335: formula
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p.000335: A=3(t¥s/t)
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p.000339: midwife, or physician assistant, the Secretary shall, from amounts appropriated under subsection (a) for a
p.000339: fiscal year, obligate not less than a total of 10 percent for contracts for both scholarships under the
p.000339: Scholarship Program under section 338A and loan repayments under the Loan Repayment Program under section 338B to
p.000339: individuals who are en- tering the first year of a course of study or program described in section
p.000339: 338A(b)(1)(B) that leads to such a certification or individ- uals who are eligible for the loan
p.000339: repayment program as specified in section 338B(b) for a loan related to such certification.
p.000339: SEC. 338I. ø254q–1¿ GRANTS TO STATES FOR LOAN REPAYMENT PRO- GRAMS.
p.000339: (a) IN GENERAL.—
p.000339: (1) AUTHORITY FOR GRANTS.—The Secretary, acting through the Administrator of the Health Resources
p.000339: and Serv- ices Administration, may make grants to States for the pur- pose of assisting the States in
p.000339: operating programs described in paragraph (2) in order to provide for the increased availability of primary health care
p.000339: services in health professional shortage areas. The National Advisory Council established under section
p.000339: 337 shall advise the Administrator regarding the program under this section.
p.000339: (2) LOAN REPAYMENT PROGRAMS.—The programs referred to in paragraph (1) are, subject to subsection
p.000339: (c), programs of entering into contracts under which the State involved agrees to pay all or part of
p.000339: the principal, interest, and related ex- penses of the educational loans of health professionals in con-
p.000339: sideration of the professionals agreeing to provide primary health services in health professional shortage
p.000339: areas.
p.000339: (3) DIRECT ADMINISTRATION BY STATE AGENCY.—The Sec- retary may not make a grant under paragraph (1)
p.000339: unless the State involved agrees that the program operated with the grant will be administered directly by a
p.000339: State agency.
p.000339: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000339: (1) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the State agrees that, with
p.000339: respect to the costs of making payments on behalf of individuals under contracts made pursuant to paragraph (2)
p.000339: of such subsection, the State will make available (directly or through donations from public or private
p.000339: entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of
p.000339: Federal funds provided in the grant.
p.000339: (2) DETERMINATION OF AMOUNT OF NON-FEDERAL CON- TRIBUTION.—In determining the amount of
p.000339: non-Federal con- tributions in cash that a State has provided pursuant to para- graph (1), the Secretary may not
p.000339: include any amounts provided to the State by the Federal Government.
p.000339: (c) COORDINATION WITH FEDERAL PROGRAM.—
p.000339: (1) ASSIGNMENTS FOR HEALTH PROFESSIONAL SHORTAGE AREAS UNDER FEDERAL PROGRAM.—The Secretary
p.000339: may not make a grant under subsection (a) unless the State involved agrees that, in carrying out the
p.000339: program operated with the grant, the State will assign health professionals participating
p.000339: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000341: PUBLIC HEALTH SERVICE ACT
p.000341: Sec. 338I
p.000341:
p.000341: in the program only to public and nonprofit private entities lo- cated in and providing health services in
p.000341: health professional shortage areas.
p.000341: (2) REMEDIES FOR BREACH OF CONTRACTS.—The Secretary may not make a grant under subsection (a) unless the State
p.000341: in- volved agrees that the contracts provided by the State pursu- ant to paragraph (2) of such
p.000341: subsection will provide remedies for any breach of the contracts by the health professionals in- volved.
p.000341: (3) LIMITATION REGARDING CONTRACT INDUCEMENTS.—
p.000341: (A) Except as provided in subparagraph (B), the Sec- retary may not make a grant under subsection (a)
p.000341: unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such
p.000341: subsection will not be provided on terms that are more favorable to health professionals than the most favorable
p.000341: terms that the Sec- retary is authorized to provide for contracts under the Loan Repayment Program under
p.000341: section 338B, including terms regarding—
p.000341: (i) the annual amount of payments provided on behalf of the professionals regarding educational loans;
p.000341: and
p.000341: (ii) the availability of remedies for any breach of the contracts by the health professionals involved.
p.000341: (B) With respect to the limitation established in sub- paragraph (A) regarding the annual amount of
p.000341: payments that may be provided to a health professional under a con- tract provided by a State pursuant to
p.000341: subsection (a)(2), such limitation shall not apply with respect to a contract if—
p.000341: (i) the excess of such annual payments above the maximum amount authorized in section 338B(g)(2)(A) for
p.000341: annual payments regarding contracts is paid solely from non-Federal contributions under subsection (b); and
p.000341:
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p.000341: (ii) the contract provides that the health profes- sional involved will satisfy the requirement of obli-
p.000341: gated service under the contract solely through the provision of primary health services in a health profes-
p.000341: sional shortage area that is receiving priority for pur- poses of section 333A(a)(1) and that is authorized to
p.000341: receive assignments under section 333 of individuals who are participating in the Scholarship Program
p.000341: under section 338A.
p.000341: (d) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not make a grant under subsection (a) unless the State
p.000341: involved agrees that the grant will not be expended—
p.000341: (1) to conduct activities for which Federal funds are ex- pended—
p.000341: (A) within the State to provide technical or other non- financial assistance under subsection (f) of section 330;
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p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
p.000377: (2) ASSURANCES.—The application shall include assurances that the State will meet the requirements of subsection (d)
p.000377: and that the State possesses sufficient infrastructure to manage the activities to be funded through the
p.000377: grant and to evaluate and report on the outcomes resulting from such activities.
p.000377: (d) MATCHING REQUIREMENT.—The Secretary may not make a grant to a State under this section unless that
p.000377: State agrees that, with respect to the costs to be incurred by the State in carrying out the activities for which the
p.000377: grant was awarded, the State will pro- vide non-Federal contributions in an amount equal to not less than 40 percent
p.000377: of Federal funds provided under the grant. The State
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p.000411: the assessment of the health of, human beings.
p.000411: (b) CERTIFICATE REQUIREMENT.—No person may solicit or ac- cept materials derived from the human body
p.000411: for laboratory exam- ination or other procedure unless there is in effect for the labora- tory a
p.000411: certificate issued by the Secretary under this section applica- ble to the category of examinations or
p.000411: procedures which includes such examination or procedure.
p.000411: (c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
p.000411: (1) IN GENERAL.—The Secretary may issue or renew a cer- tificate for a laboratory only if the laboratory meets
p.000411: the re- quirements of subsection (d).
p.000411: (2) TERM.—A certificate issued under this section shall be valid for a period of 2 years or such shorter period
p.000411: as the Sec- retary may establish.
p.000411: (d) REQUIREMENTS FOR CERTIFICATES.—
p.000411: (1) IN GENERAL.—A laboratory may be issued a certificate or have its certificate renewed if—
p.000411: (A) the laboratory submits (or if the laboratory is ac- credited under subsection (e), the accreditation body
p.000411: which accredited the laboratory submits), an application—
p.000411: (i) in such form and manner as the Secretary shall prescribe,
p.000411: (ii) that describes the characteristics of the labora- tory examinations and other procedures performed by the
p.000411: laboratory including—
p.000411: (I) the number and types of laboratory exami- nations and other procedures performed,
p.000411: (II) the methodologies for laboratory examina- tions and other procedures employed, and
p.000411: (III) the qualifications (educational back- ground, training, and experience) of the personnel directing
p.000411: and supervising the laboratory and per- forming the laboratory examinations and other procedures, and
p.000411: (iii) that contains such other information as the Secretary may require to determine compliance with this
p.000411: section, and
p.000411: the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body
p.000411: which accredited it) a description of any change in the informa- tion submitted under clause (ii) not
p.000411: later than 6 months after the change was put into effect,
p.000411: (B) the laboratory provides the Secretary—
p.000411: (i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the
p.000411: Secretary under subsection (f), or
p.000411: (ii) with proof of accreditation under subsection
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p.000411: (e),
p.000411: (C) the laboratory agrees to permit inspections by the Secretary under subsection (g),
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p.000413: 413
p.000413: PUBLIC HEALTH SERVICE ACT
p.000413: Sec. 353
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p.000413: (D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may
p.000413: reasonably require, and
p.000413: (E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived
p.000413: from the human body referred to it for laboratory examina- tions or other procedures in the ordinary course of
p.000413: busi- ness, except that no proficiency testing sample shall be re- ferred to another laboratory for analysis as
p.000413: prohibited under subsection (i)(4).
p.000413: (2) REQUIREMENTS FOR CERTIFICATES OF WAIVER.—
p.000413: (A) IN GENERAL.—A laboratory which only performs laboratory examinations and procedures described in para- graph
p.000413: (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if—
p.000413: (i) the laboratory submits an application—
p.000413: (I) in such form and manner as the Secretary shall prescribe,
p.000413: (II) that describes the characteristics of the laboratory examinations and other procedures per- formed by the
p.000413: laboratory, including the number and types of laboratory examinations and other procedures performed, the
p.000413: methodologies for lab- oratory examinations and other procedures em- ployed, and the qualifications
p.000413: (educational back- ground, training, and experience) of the personnel directing and supervising the laboratory
p.000413: and per- forming the laboratory examinations and other procedures, and
p.000413: (III) that contains such other information as the Secretary may reasonably require to deter- mine
p.000413: compliance with this section, and
p.000413: (ii) the laboratory agrees to make records avail- able and submit reports to the Secretary as the Sec-
p.000413: retary may require.
p.000413: (B) CHANGES.—If a laboratory makes changes in the examinations and other procedures performed by it only
p.000413: with respect to examinations and procedures which are de- scribed in paragraph (3), the laboratory shall report
p.000413: such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory
p.000413: proposes to make changes in the examinations and procedures per- formed by it such that the laboratory
p.000413: will perform an ex- amination or procedure not described in paragraph (3), the laboratory shall report such change
p.000413: to the Secretary before the change takes effect.
p.000413: (C) EFFECT.—Subsections (f) and (g) shall not apply to a laboratory to which has been issued a certificate of waiv- er.
p.000413: (3) EXAMINATIONS AND PROCEDURES.—The examinations and procedures identified in paragraph (2) are
p.000413: laboratory ex- aminations and procedures that have been approved by the Food and Drug Administration for home
p.000413: use or that, as deter- mined by the Secretary, are simple laboratory examinations
p.000413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000413:
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p.000425: (c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
p.000425: (1) IN GENERAL.—The Secretary may issue or renew a cer- tificate for a facility if the person or agent
p.000425: described in sub- section (d)(1)(A) meets the applicable requirements of sub- section (d)(1) with respect
p.000425: to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years.
p.000425: (2) TEMPORARY RENEWAL CERTIFICATE.—The Secretary may issue a temporary renewal certificate, for a
p.000425: period of not to exceed 45 days, to a facility seeking reaccreditation if the ac- creditation body has issued an
p.000425: accreditation extension, for a period of not to exceed 45 days, for any of the following:
p.000425: (A) The facility has submitted the required materials to the accreditation body within the
p.000425: established time frames for the submission of such materials but the ac- creditation body is unable to
p.000425: complete the reaccreditation process before the certification expires.
p.000425: (B) The facility has acquired additional or replacement equipment, or has had significant personnel changes or
p.000425: other unforeseen situations that have caused the facility to be unable to meet reaccreditation timeframes, but
p.000425: in the opinion of the accreditation body have not compromised the quality of mammography.
p.000425: (3) LIMITED PROVISIONAL CERTIFICATE.—The Secretary may, upon the request of an accreditation body, issue a
p.000425: limited provisional certificate to an entity to enable the entity to con- duct examinations for
p.000425: educational purposes while an onsite visit from an accreditation body is in progress. Such certificate shall be
p.000425: valid only during the time the site visit team from the accreditation body is physically in the facility, and
p.000425: in no case shall be valid for longer than 72 hours. The issuance of a cer- tificate under this paragraph, shall
p.000425: not preclude the entity from qualifying for a provisional certificate under paragraph (4).
p.000425:
p.000425:
p.000425:
p.000425:
p.000425: January 30, 2020
p.000425: 71 So in law. The article ‘‘a’’ appears before both ‘‘temporary renewal certificate’’ and ‘‘limited provisional
p.000425: certificate’’. See section 2(1)(C) of Public Law 108–365 (118 Stat. 1738).
p.000425: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000425: except providing in- formation required by clauses (iii) and (iv) of subsection (d)(1)(A). A
p.000425: provisional certificate may be in effect no longer than 6 months from the date it is issued, except
p.000425: that it may be extended once for a period of not more than 90 days if the owner, lessor, or agent of the
p.000425: facility demonstrates to the Sec- retary that without such extension access to mammography in the geographic area
p.000425: served by the facility would be signifi- cantly reduced and if the owner, lessor, or agent of the facility will
p.000425: describe in a report to the Secretary steps that will be taken to qualify the facility for
p.000425: certification under subsection (b)(1).
p.000425: (d) APPLICATION FOR CERTIFICATE.—
p.000425: (1) SUBMISSION.—The Secretary may issue or renew a cer- tificate for a facility if—
p.000425: (A) the person who owns or leases the facility or an authorized agent of the person, submits to the
p.000425: Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum—
p.000425: (i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and proc-
p.000425: essor operated in the performance of mammography by the facility;
p.000425: (ii) a description of the procedures currently used to provide mammography at the facility, including—
p.000425: (I) the types of procedures performed and the number of such procedures performed in the prior 12 months;
p.000425: (II) the methodologies for mammography; and
p.000425: (III) the names and qualifications (educational background, training, and experience) of the per- sonnel
p.000425: performing mammography and the physi- cians reading and interpreting the results from the procedures;
p.000425: (iii) proof of on-site survey by a qualified medical physicist as described in subsection (f)(1)(E); and
p.000425: (iv) proof of accreditation in such manner as the Secretary shall prescribe; and
p.000425: (B) the person or agent submits to the Secretary—
p.000425: (i) a satisfactory assurance that the facility will be operated in accordance with standards established by the
p.000425: Secretary under subsection (f) to assure the safety and accuracy of mammography;
p.000425: (ii) a satisfactory assurance that the facility will—
p.000425: (I) permit inspections under subsection (g);
p.000425: (II) make such records and information avail- able, and submit such reports, to the Secretary as the Secretary may
p.000425: require; and
p.000425: (III) update the information submitted under subparagraph (A) or assurances submitted under
p.000425: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000427: 427
p.000427: PUBLIC HEALTH SERVICE ACT
p.000427: Sec. 354
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p.000453: Sec. 377B PUBLIC HEALTH SERVICE ACT 454
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p.000453: January 30, 2020
p.000453:
p.000453: (A) submit an application to the Department in the form prescribed;
p.000453: (B) establish yearly benchmarks for improvement in organ donation rates in the State; and
p.000453: (C) report to the Secretary on an annual basis a de- scription and assessment of the State’s use of
p.000453: funds re- ceived under this subsection, accompanied by an assess- ment of initiatives for potential replication
p.000453: in other States.
p.000453: (3) USE OF FUNDS.—Funds received under this subsection may be used by the State, or in partnership with other
p.000453: public agencies or private sector institutions, for education and awareness efforts, information
p.000453: dissemination, activities per- taining to the State donor registry, and other innovative dona- tion specific
p.000453: initiatives, including living donation.
p.000453: (d) EDUCATIONAL ACTIVITIES.—The Secretary, in coordination with the Organ Procurement and Transplantation
p.000453: Network and other appropriate organizations, shall support the development and dissemination of educational
p.000453: materials to inform health care pro- fessionals and other appropriate professionals in issues sur-
p.000453: rounding organ, tissue, and eye donation including evidence-based proven methods to approach patients and
p.000453: their families, cultural sensitivities, and other relevant issues.
p.000453: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000453: to be appropriated
p.000453: $15,000,000 for fiscal year 2005, and such sums as may be nec- essary for each of the fiscal years 2006
p.000453: through 2009. Such author- ization of appropriations is in addition to any other authorizations of appropriations that
p.000453: are available for such purpose.
p.000453: SEC. 377B. ø274f–2¿ GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.
p.000453: (a) AUTHORITY.—
p.000453: (1) IN GENERAL.—The Secretary may award grants to qualified organ procurement organizations and hospitals
p.000453: under section 371 to establish programs coordinating organ donation activities of eligible hospitals and
p.000453: qualified organ procurement organizations under section 371. Such activities shall be coordi- nated to increase the
p.000453: rate of organ donations for such hos- pitals.
p.000453: (2) ELIGIBLE HOSPITAL.—For purposes of this section, the term ‘‘eligible hospital’’ means a hospital that
p.000453: performs signifi- cant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer
p.000453: than 200,000 individuals.
p.000453: (b) ADMINISTRATION OF COORDINATION PROGRAM.—A condition for the receipt of a grant under subsection (a) is that
...

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p.000459: Sec. 379 PUBLIC HEALTH SERVICE ACT 460
p.000459:
p.000459: (d) FUNCTIONS.— 84
p.000459: (1) BONE MARROW FUNCTIONS.—With respect to bone mar- row, the Program shall—
p.000459: (A) operate a system for identifying, matching, and fa- cilitating the distribution of bone marrow that is
p.000459: suitably matched to candidate patients;
p.000459: (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care
p.000459: professionals, and patients to search by means of electronic access all available bone marrow donors listed in
p.000459: the Program;
p.000459: (C) carry out a program for the recruitment of bone marrow donors in accordance with subsection (e), including
p.000459: with respect to increasing the representation of racial and ethnic minority groups (including persons of mixed
p.000459: ances- try) in the enrollment of the Program;
p.000459: (D) maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000459: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000459: January 30, 2020
p.000459:
p.000459: ‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
p.000459: ‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller General of the
p.000459: United States shall conduct a study of the National Bone Marrow Donor Registry under section 379 of the Public
p.000459: Health Service Act for purposes of making determinations of the following:
p.000459: ‘‘(1) The extent to which, relative to the effective date of this Act, such Registry has in- creased
p.000459: the representation of racial and ethnic minority groups (including persons of mixed ancestry) among potential donors
p.000459: of bone marrow who are enrolled with the Registry, and whether the extent of increase results in a level of
p.000459: representation that meets the standard established in subsection (c)(1)(A) of such section 379 (as added by section
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p.000461: (I) remote collection of cord blood units, con- sistent with the requirements under the Program and the
p.000461: National Cord Blood Inventory program
p.000461:
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p.000461: January 30, 2020
p.000461: 85 Margin so in law. The amendment by section 2(b)(2)(A)(ii) of Public Law 111–264 redesig- nates
p.000461: subpargraphs (A)–(H) as clauses (i)–(viii); however, the amendment did not move the mar- gins of such clauses to the
p.000461: right so that it appears indented 6 ems from the left margin (except for clause (iv) which was amended in its
p.000461: entirety by section 2(b)(2)(A)(iii) of such Public Law and as rewritten appears on the correct margin).
p.000461: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000461: Sec. 379 PUBLIC HEALTH SERVICE ACT 462
p.000461:
p.000461: goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005; and
p.000461: (II) exploring novel approaches or incentives to encourage innovative technological advances that could be
p.000461: used to collect cord blood units, con- sistent with the requirements under the Program and such National Cord
p.000461: Blood Inventory program goal;
p.000461: (v) 85 provide for a system of patient advocacy through the office established under subsection (h);
p.000461: (vi) 85 coordinate with the qualified cord blood banks to support informational and educational activities in accord-
p.000461: ance with subsection (g);
p.000461: (vii) 85 maintain and expand medical contingency re- sponse capabilities, in coordination with Federal programs,
p.000461: to prepare for and respond effectively to biological, chem- ical, or radiological attacks, and other public
p.000461: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000461: disease can be used to support casualties with marrow damage; and
p.000461: (viii) 85 with respect to the system under subparagraph (A), collect, analyze, and publish data in a
p.000461: standardized electronic format, as required by the Secretary, on the number and percentage of patients at
p.000461: each of the various stages of the search process, including data regarding the furthest stage reached,
p.000461: the number and percentage of pa- tients who are unable to complete the search process, and the reasons underlying
p.000461: such circumstances.
p.000461: (B) EFFORTS TO INCREASE COLLECTION OF HIGH QUAL- ITY CORD BLOOD UNITS.—In carrying out subparagraph
p.000461: (A)(iv), not later than 1 year after the date of enactment of the Stem Cell Therapeutic and Research
p.000461: Reauthoriza- tion Act of 2010 and annually thereafter, the Secretary shall set an annual goal of
p.000461: increasing collections of high quality cord blood units, øincluding remote collection,¿ 86 consistent with the
p.000461: inventory goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (re- ferred to in
p.000461: this subparagraph as the ‘‘inventory goal’’), and shall identify at least one project under subparagraph (A)(iv)
p.000461: to replicate and expand nationwide, as appropriate. If the Secretary cannot identify a project as described in
...

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p.000463: Sec. 379 PUBLIC HEALTH SERVICE ACT 464
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p.000463: lation, to the extent practicable, to have a probability of finding a suitable unrelated donor that is
p.000463: comparable to the probability that an individual who is not a member of an underrepresented population would have.
p.000463: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000463: to be populations that have been identified for purposes of this paragraph, and shall carry out
p.000463: subparagraph (A) with re- spect to such populations.
p.000463: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND ENROLLMENT.—
p.000463: (A) IN GENERAL.—The Program shall carry out infor- mational and educational activities, in coordination
p.000463: with organ donation public awareness campaigns operated through the Department of Health and Human
p.000463: Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll
p.000463: with the Program potential bone marrow donors. Such information and edu- cational activities shall include the
p.000463: following:
p.000463: (i) Making information available to the general public, including information describing the needs of
p.000463: patients with respect to donors of bone marrow.
p.000463: (ii) Educating and providing information to indi- viduals who are willing to serve as potential bone mar- row
p.000463: donors.
p.000463: (iii) Training individuals in requesting individuals to serve as potential bone marrow donors.
p.000463: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000463: Pro- gram shall give priority to recruiting individuals to serve as donors of bone marrow for populations
p.000463: that are identi- fied under paragraph (1).
p.000463: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000463: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000463: the public regarding bone marrow transplants from unrelated donors as a treatment op- tion.
p.000463: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000463: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000463: subsection (d)(1).
p.000463: (f) BONE MARROW CRITERIA, STANDARDS, AND PROCEDURES.— The Secretary shall enforce, for participating entities,
p.000463: including the Program, individual marrow donor centers, marrow donor reg- istries, marrow collection centers,
p.000463: and marrow transplant centers—
p.000463: (1) quality standards and standards for tissue typing, ob- taining the informed consent of donors, and
p.000463: providing patient advocacy;
p.000463: (2) donor selection criteria, based on established medical criteria, to protect both the donor and the recipient
p.000463: and to pre- vent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis
p.000463: and the etiologic agent for Acquired Immune Deficiency Syndrome;
p.000463: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000465: (g) CORD BLOOD RECRUITMENT; PRIORITIES; INFORMATION AND
p.000465: EDUCATION.—
p.000465: (1) RECRUITMENT; PRIORITIES.—The Program shall support activities, in cooperation with qualified cord blood
p.000465: banks, for the recruitment of cord blood donors. Such recruitment pro- gram shall identify populations
p.000465: that are underrepresented among cord blood donors. In the case of populations that are identified under
p.000465: the preceding sentence:
p.000465: (A) The Program shall give priority to supporting ac- tivities under this part to increase representation for
p.000465: such populations in order to enable a member of such a popu- lation, to the extent practicable, to have
p.000465: a probability of finding a suitable cord blood unit that is comparable to the probability that an individual who
p.000465: is not a member of an underrepresented population would have.
p.000465: (B) The Program shall consider racial and ethnic mi- nority groups (including persons of mixed ancestry)
p.000465: to be populations that have been identified for purposes of this paragraph, and shall support activities
p.000465: under subpara- graph (A) with respect to such populations.
p.000465: (2) INFORMATION AND EDUCATION REGARDING RECRUIT- MENT; TESTING AND DONATION.—
p.000465: (A) IN GENERAL.—In carrying out the recruitment pro- gram under paragraph (1), the Program shall support in-
p.000465: formational and educational activities in coordination with qualified cord blood banks and organ donation
p.000465: public awareness campaigns operated through the Department of Health and Human Services, for purposes of
p.000465: recruiting pregnant women to serve as donors of cord blood. Such in- formation and educational activities shall
p.000465: include the fol- lowing:
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p.000465: January 30, 2020
p.000465: (i) Making information available to the general public, including information describing the needs of
p.000465: patients with respect to cord blood units.
p.000465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000465: (ii) Educating and providing information to preg- nant women who are willing to donate cord blood units.
p.000465: (iii) Training individuals in requesting pregnant women to serve as cord blood donors.
p.000465: (B) PRIORITIES.—In carrying out informational and educational activities under subparagraph (A), the
p.000465: Pro- gram shall give priority to supporting the recruitment of pregnant women to serve as donors of cord blood
p.000465: for popu- lations that are identified under paragraph (1).
p.000465: (3) TRANSPLANTATION AS TREATMENT OPTION.—In addition to activities regarding recruitment, the recruitment
p.000465: program under paragraph (1) shall provide information to physicians, other health care professionals, and
p.000465: the public regarding cord blood transplants from donors as a treatment option.
p.000465: (4) IMPLEMENTATION OF SUBSECTION.—The requirements of this subsection shall be carried out by the entity that has
p.000465: been awarded a contract by the Secretary under subsection (a) to carry out the functions described in
p.000465: subsection (d)(2).
p.000465: (h) PATIENT ADVOCACY AND CASE MANAGEMENT FOR BONE MARROW AND CORD BLOOD.—
p.000465: (1) IN GENERAL.—The Secretary shall establish and main- tain, through a contract or other means
p.000465: determined appro- priate by the Secretary, an office of patient advocacy (in this subsection referred to as
p.000465: the ‘‘Office’’).
p.000465: (2) GENERAL FUNCTIONS.—The Office shall meet the fol- lowing requirements:
p.000465: (A) The Office shall be headed by a director.
p.000465: (B) The Office shall be staffed by individuals with ex- pertise in bone marrow and cord blood therapy covered
p.000465: under the Program.
p.000465: (C) The Office shall operate a system for patient advo- cacy, which shall be separate from mechanisms for donor
p.000465: advocacy, and which shall serve patients for whom the Program is conducting, or has been requested to
...

p.000473: SEC. 393A. ø280b–1b¿ USE OF ALLOTMENTS FOR RAPE PREVENTION EDUCATION.
p.000473: (a) PERMITTED USE.—The Secretary, acting through the Na- tional Center for Injury Prevention and Control at the
p.000473: Centers for Disease Control and Prevention, shall award targeted grants to States to be used for rape
p.000473: prevention and education programs con- ducted by rape crisis centers, State, territorial or tribal sexual as-
p.000473: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000473: Sec. 393A PUBLIC HEALTH SERVICE ACT 474
p.000473: sault coalitions, and other public and private nonprofit entities for—
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p.000473: (1) educational seminars;
p.000473: (2) the operation of hotlines;
p.000473: (3) training programs for professionals;
p.000473: (4) the preparation of informational material;
p.000473: (5) education and training programs for students and cam- pus personnel designed to reduce the incidence of
p.000473: sexual as- sault at colleges and universities;
p.000473: (6) education to increase awareness about drugs and alco- hol used to facilitate rapes or sexual assaults; and
p.000473: (7) other efforts to increase awareness of the facts about, or to help prevent, sexual assault, including
p.000473: efforts to increase awareness in underserved communities and awareness among individuals with disabilities (as
p.000473: defined in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102)).
p.000473: (b) COLLECTION AND DISSEMINATION OF INFORMATION ON SEX- UAL ASSAULT.—The Secretary shall, through the National
p.000473: Resource Center on Sexual Assault established under the National Center for Injury Prevention and Control
p.000473: at the Centers for Disease Con- trol and Prevention, provide resource information, policy, training, and
p.000473: technical assistance to Federal, State, local, and Indian tribal agencies, as well as to State sexual assault
p.000473: coalitions and local sex- ual assault programs and to other professionals and interested par- ties on issues
p.000473: relating to sexual assault, including maintenance of a central resource library in order to collect, prepare,
p.000473: analyze, and disseminate information and statistics and analyses thereof relat- ing to the incidence and
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p.000477: (A) conduct and support research to—
p.000477: (i) improve the identification of older adults who have a high risk of falling;
p.000477: (ii) improve data collection and analysis to identify fall risk and protective factors;
p.000477: (iii) design, implement, and evaluate the most ef- fective fall prevention interventions;
p.000477: (iv) improve strategies that are proven to be effec- tive in reducing falls by tailoring these strategies to
p.000477: specific populations of older adults;
p.000477: (v) conduct research in order to maximize the dis- semination of proven, effective fall prevention inter-
p.000477: ventions;
p.000477: (vi) intensify proven interventions to prevent falls among older adults;
p.000477: (vii) improve the diagnosis, treatment, and reha- bilitation of elderly fall victims and older adults at
p.000477: high risk for falls; and
p.000477: (viii) assess the risk of falls occurring in various settings;
p.000477: (B) conduct research concerning barriers to the adop- tion of proven interventions with respect to the
p.000477: prevention of falls among older adults;
p.000477: (C) conduct research to develop, implement, and evalu- ate the most effective approaches to reducing falls
p.000477: among high-risk older adults living in communities and long-term care and assisted living facilities; and
p.000477: (D) evaluate the effectiveness of community programs designed to prevent falls among older adults.
p.000477: (2) EDUCATIONAL SUPPORT.—The Secretary, either directly or through awarding grants, contracts, or
p.000477: cooperative agree- ments to qualified organizations, institutions, or consortia of qualified organizations
p.000477: and institutions, specializing, or dem- onstrating expertise, in falls or fall prevention, may provide
p.000477: professional education for physicians and allied health profes- sionals, and aging service providers in fall
p.000477: prevention, evalua- tion, and management.
p.000477: (c) DEMONSTRATION PROJECTS.—The Secretary may carry out the following:
p.000477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000521: an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant
p.000521: may be made only if an application for the grant is
p.000521:
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p.000521: January 30, 2020
p.000521: 102 Enacted October 27, 1992.
p.000521:
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000521: Sec. 399H PUBLIC HEALTH SERVICE ACT 522
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p.000521: submitted to the Secretary containing such agreement, and the application is in such form, is made in such
p.000521: manner, and contains such other agreements and such assurances and information as the Secretary determines
p.000521: to be nec- essary to carry out this paragraph.
p.000521:
p.000521: PART O—FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM
p.000521:
p.000521: SEC. 399H. ø280f¿ ESTABLISHMENT OF FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM.
p.000521: (a) FETAL ALCOHOL SYNDROME PREVENTION, INTERVENTION AND SERVICES DELIVERY PROGRAM.—The Secretary
p.000521: shall establish a comprehensive Fetal Alcohol Syndrome and Fetal Alcohol Effect prevention,
p.000521: intervention and services delivery program that shall include—
p.000521: (1) an education and public awareness program to support, conduct, and evaluate the effectiveness of—
p.000521: (A) educational programs targeting medical schools, social and other supportive services, educators and
p.000521: coun- selors and other service providers in all phases of child- hood development, and other relevant
p.000521: service providers, concerning the prevention, identification, and provision of services for children,
p.000521: adolescents and adults with Fetal Al- cohol Syndrome and Fetal Alcohol Effect;
p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
p.000521: and
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p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.000523: technical assistance to eligible entities described in section 399I to carry out subsection (a).
p.000523: (c) DISSEMINATION OF CRITERIA.—In carrying out this section, the Secretary shall develop a procedure for
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p.000529: TEMS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall
p.000529: make awards of grants or cooperative agreements to develop statewide newborn, infant, and young child hearing
p.000529: screening, evaluation, diagnosis, and intervention programs and systems, and to assist in the re-
p.000529: cruitment, retention, education, and training of qualified personnel and health care providers (including, as
p.000529: appropriate, education and training of family members), for the following purposes:
p.000529: (1) To develop and monitor the efficacy of statewide pro- grams and systems for hearing screening of newborns,
p.000529: infants, and young children (referred to in this section as ‘‘children’’); prompt evaluation and
p.000529: diagnosis of children referred from screening programs; and appropriate educational, audiological, medical,
p.000529: and communication (or language acquisition) inter- ventions (including family support), for children
p.000529: identified as deaf or hard-of-hearing, consistent with the following:
p.000529: (A) Early intervention includes referral to, and deliv- ery of, information and services by organizations
p.000529: such as schools and agencies (including community, consumer, and family-based agencies), in health care settings
p.000529: (including medical homes for children), and in programs mandated by part C of the Individuals with Disabilities
p.000529: Education Act, which offer programs specifically designed to meet the unique language and communication
p.000529: needs of deaf and hard-of-hearing children.
p.000529: (B) Information provided to families should be accu- rate, comprehensive, up-to-date, and evidence-based,
p.000529: as appropriate, to allow families to make important decisions for their children in a timely manner, including
p.000529: decisions with respect to the full range of assistive hearing tech- nologies and communications modalities, as
p.000529: appropriate.
p.000529: (C) Programs and systems under this paragraph shall offer mechanisms that foster family-to-family and deaf and
p.000529: hard-of-hearing consumer-to-family supports.
p.000529: (2) To continue to provide technical support to States, through one or more technical resource centers, to
p.000529: assist in fur- ther developing and enhancing State early hearing detection and intervention programs.
p.000529: (3) To identify or develop efficient models (educational and medical) to ensure that children who are identified
p.000529: as deaf or hard-of-hearing through screening receive follow-up by quali- fied early intervention providers
p.000529: or qualified health care pro- viders (including those at medical homes for children), and re- ferrals, as
p.000529: appropriate, including to early intervention services under part C of the Individuals with Disabilities
p.000529: Education Act. State agencies shall be encouraged to effectively increase the rate of such follow-up and
p.000529: referral.
p.000529: (b) TECHNICAL ASSISTANCE, DATA MANAGEMENT, AND APPLIED RESEARCH.—
p.000529: (1) CENTERS FOR DISEASE CONTROL AND PREVENTION.—
p.000529: (A) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Preven-
p.000529: tion, shall make awards of grants or cooperative agree-
p.000529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000529: Sec. 399M PUBLIC HEALTH SERVICE ACT 530
p.000529:
p.000529: ments to provide technical assistance to State agencies or designated entities of States—
p.000529: (i) to develop, maintain, and improve data collec- tion systems related to newborn, infant, and young
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p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
p.000531: direction for medical or surgical treatment options for hearing loss or other medical disorders associated with hearing
p.000531: loss.
p.000531: (5) The term ‘‘newborn, infant, and young child hearing screening’’ means objective physiologic procedures
p.000531: to detect possible hearing loss and to identify newborns, infants, and young children under 3 years
p.000531: of age who require further audiologic and medical evaluations.
p.000531: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000531:
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p.000531: 105 Section 2(f)(5) of Public Law 115-71 provides: ‘‘in paragraph (3) (as redesignated by para- graph (3)
p.000531: of this subsection), by striking ‘‘(3)’’ and all that follows through ‘‘decision making’’ and inserting
p.000531: ‘‘The term ‘medical evaluation’ means key components performed by a physician including history,
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p.000535: January 30, 2020
p.000535: for the unauthorized use and disclosure of information maintained by the PDMP.
p.000535: (b) PDMP STRATEGIES.—The Secretary shall encourage a State or locality, in establishing, improving, or
p.000535: maintaining a PDMP, to implement strategies that improve—
p.000535: (1) the reporting of dispensing in the State or locality of a controlled substance to an ultimate user so the
p.000535: reporting oc- curs not later than 24 hours after the dispensing event;
p.000535: (2) the consultation of the PDMP by each prescribing prac- titioner, or their designee, in the State or
p.000535: locality before initi- ating treatment with a controlled substance, or any substance as required by the State
p.000535: to be reported to the PDMP, and over the course of ongoing treatment for each prescribing event;
p.000535: (3) the consultation of the PDMP before dispensing a con- trolled substance, or any substance as required by the State
p.000535: to be reported to the PDMP;
p.000535: (4) the proactive notification to a practitioner when pat- terns indicative of controlled substance misuse by a
p.000535: patient, in- cluding opioid misuse, are detected;
p.000535: (5) the availability of data in the PDMP to other States, as allowable under State law; and
p.000535: (6) the availability of nonidentifiable information to the Centers for Disease Control and Prevention for
p.000535: surveillance, epidemiology, statistical research, or educational purposes.
p.000535: (c) DRUG MISUSE AND ABUSE.—In consultation with practi- tioners, dispensers, and other relevant and interested
p.000535: stakeholders, a State receiving support under this section—
p.000535: (1) shall establish a program to notify practitioners and dispensers of information that will help to identify
p.000535: and prevent the unlawful diversion or misuse of controlled substances;
p.000535: (2) may, to the extent permitted under State law, notify the appropriate authorities responsible for
p.000535: carrying out drug diversion investigations if the State determines that informa- tion in the PDMP maintained
p.000535: by the State indicates an unlaw- ful diversion or abuse of a controlled substance;
p.000535: (3) may conduct analyses of controlled substance program data for purposes of providing appropriate State
p.000535: agencies with aggregate reports based on such analyses in as close to real-
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541: assault nurse examiner programs;
p.000541: (iii) the inclusion of the health effects of lifetime exposure to violence and abuse as well as related pro-
p.000541: tective factors and behavioral risk factors in health professional training schools including medical, dental,
p.000541: nursing, social work, and mental and behavioral health curricula, and allied health service training
p.000541: courses; or
p.000541: (iv) the integration of knowledge of domestic vio- lence, dating violence, sexual assault, and stalking
p.000541: into health care accreditation and professional licens- ing examinations, such as medical, dental, social work,
p.000541: and nursing boards, and where appropriate, other al- lied health exams.
p.000541: (c) REQUIREMENTS FOR GRANTEES.—
p.000541: (1) CONFIDENTIALITY AND SAFETY.—
p.000541: (A) IN GENERAL.—Grantees under this section shall ensure that all programs developed with grant funds ad-
p.000541: dress issues of confidentiality and patient safety and com- ply with applicable confidentiality and nondisclosure
p.000541: re- quirements under section 40002(b)(2) of the Violence Against Women Act of 1994 and the Family Violence
p.000541: Pre- vention and Services Act, and that faculty and staff associ- ated with delivering educational components
p.000541: are fully trained in procedures that will protect the immediate and ongoing security and confidentiality
p.000541: of the patients, pa- tient records, and staff. Such grantees shall consult enti- ties with demonstrated
p.000541: expertise in the confidentiality and safety needs of victims of domestic violence, dating vio- lence, sexual
p.000541: assault, and stalking on the development and adequacy of confidentially and security procedures, and provide
p.000541: documentation of such consultation.
p.000541: (B) ADVANCE NOTICE OF INFORMATION DISCLOSURE.— Grantees under this section shall provide to patients
p.000541: ad- vance notice about any circumstances under which infor- mation may be disclosed, such as mandatory
p.000541: reporting laws, and shall give patients the option to receive informa- tion and referrals without affirmatively
p.000541: disclosing abuse.
p.000541: (2) LIMITATION ON ADMINISTRATIVE EXPENSES.—A grantee shall use not more than 10 percent of the amounts
p.000541: received under a grant under this section for administrative expenses.
p.000541: (3) APPLICATION.—
p.000541: (A) PREFERENCE.—In selecting grant recipients under this section, the Secretary shall give preference to
p.000541: appli- cants based on the strength of their evaluation strategies, with priority given to outcome based evaluations.
p.000541: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000541:
p.000541: (B) SUBSECTION (A)(1) AND (2) GRANTEES.—Applications for grants under paragraphs (1) and (2) of subsection
p.000541: (a) shall include—
p.000541: (i) documentation that the applicant represents a team of entities working collaboratively to strengthen
p.000541: the response of the health care system to domestic vio- lence, dating violence, sexual assault, or stalking, and which
p.000541: includes at least one of each of—
p.000541: (I) an accredited school of allopathic or osteo- pathic medicine, psychology, nursing, dentistry, social
p.000541: work, or other health field;
p.000541: (II) a health care facility or system; or
p.000541: (III) a government or nonprofit entity with a history of effective work in the fields of domestic
p.000541: violence, dating violence, sexual assault, or stalk- ing; and
p.000541: (ii) strategies for the dissemination and sharing of curricula and other educational materials developed under
p.000541: the grant, if any, with other interested health professions schools and national resource repositories for
p.000541: materials on domestic violence, dating violence, sexual assault, and stalking.
p.000541: (C) SUBSECTION (A)(3) GRANTEES.—An entity desiring a grant under subsection (a)(3) shall submit an application
p.000541: to the Secretary at such time, in such a manner, and con- taining such information and assurances as the
p.000541: Secretary may require, including—
p.000541: (i) documentation that all training, education, screening, assessment, services, treatment, and any
p.000541: other approach to patient care will be informed by an understanding of violence and abuse victimization and
p.000541: trauma-specific approaches that will be integrated into prevention, intervention, and treatment activities;
p.000541: (ii) strategies for the development and implemen- tation of policies to prevent and address domestic vio- lence,
p.000541: dating violence, sexual assault, and stalking over the lifespan in health care settings;
p.000541: (iii) a plan for consulting with State and tribal do- mestic violence or sexual assault coalitions, national
...

p.000551: part- nerships between health care professional groups and dis- ability advocacy organizations.
p.000551:
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p.000551: January 30, 2020
p.000551: 107 So in law. Probably should read ‘‘section 2(1)’’.
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: 553
p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000553: January 30, 2020
p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
...

p.000559: (C) health care utilization by individuals with con- genital heart disease;
p.000559: (D) demographic factors associated with congenital heart disease, such as age, race, ethnicity, sex, and
p.000559: family history of individuals who are diagnosed with the disease; and
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p.000559: January 30, 2020
p.000559: (E) evidence-based practices related to care and treat- ment for individuals with congenital heart disease.
p.000559: (2) PERMISSIBLE CONSIDERATIONS.—In carrying out the ac- tivities under this section, the Secretary may, as appropriate—
p.000559: (A) collect data on the health outcomes, including be- havioral and mental health outcomes, of a diverse
p.000559: popu- lation of individuals of all ages with congenital heart dis- ease, such that analysis of the
p.000559: outcomes will inform evi- dence-based practices for individuals with congenital heart disease; and
p.000559: (B) consider health disparities among individuals with congenital heart disease, which may include the consider-
p.000559: ation of prenatal exposures.
p.000559: (c) AWARENESS CAMPAIGN.—The Secretary may carry out awareness and educational activities related to
p.000559: congenital heart disease in individuals of all ages, which may include information for patients, family
p.000559: members, and health care providers, on topics such as the prevalence of such disease, the effect of
p.000559: such disease on individuals of all ages, and the importance of long-term, special- ized care for individuals with such
p.000559: disease.
p.000559: (d) PUBLIC ACCESS.—The Secretary shall ensure that, subject to subsection (e), information collected under
p.000559: this section is made available, as appropriate, to the public, including researchers.
p.000559: (e) PATIENT PRIVACY.—The Secretary shall ensure that the data and information collected under this section
p.000559: are made avail- able in a manner that, at a minimum, protects personal privacy to the extent required by applicable
p.000559: Federal and State law.
p.000559: (f) ELIGIBILITY FOR GRANTS.—To be eligible to receive a grant under subsection (a)(3), an entity shall—
p.000559: (1) be a public or private nonprofit entity with specialized experience in congenital heart disease; and
p.000559: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000559: Sec- retary may require.
p.000559: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000559: $10,000,000 for each of fiscal years 2020 through 2024.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: may award grants or cooperative agreements to eligible entities for the collection, analysis, and reporting of
p.000577: State epidemiological data for children and adults with autism spectrum disorder and other developmental
p.000577: disabilities. An eligible entity shall assist with the development and coordination of State autism
p.000577: spectrum disorder and other developmental disability surveil- lance efforts within a region. In making such
p.000577: awards, the Sec- retary may provide direct technical assistance in lieu of cash.
p.000577: (2) DATA STANDARDS.—In submitting epidemiological data to the Secretary pursuant to paragraph (1), an
p.000577: eligible entity shall report data according to guidelines prescribed by the Di- rector of the Centers for Disease
p.000577: Control and Prevention, after consultation with relevant State, local, and Tribal public health
p.000577: officials, private sector developmental disability re- searchers, and advocates for individuals with autism
p.000577: spectrum disorder and other developmental disabilities.
p.000577: (3) ELIGIBILITY.—To be eligible to receive an award under paragraph (1), an entity shall be a public or
p.000577: nonprofit private entity (including a health department of a State or a political subdivision of a
p.000577: State, a university, any other educational in- stitution, an Indian tribe, or a tribal organization), and submit
p.000577: to the Secretary an application at such time, in such manner, and containing such information as the
p.000577: Secretary may require.
p.000577: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000577: (b) CENTERS OF EXCELLENCE IN AUTISM SPECTRUM DISORDER EPIDEMIOLOGY.—
p.000577: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention,
p.000577: shall, subject to the availability of appropriations, award grants or cooperative agreements for the
p.000577: establishment or support of re- gional centers of excellence in autism spectrum disorder and other
p.000577: developmental disabilities epidemiology for the purpose of collecting and analyzing information on the
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p.000581: individuals with autism spectrum dis- order and developmental disabilities and their family members,
p.000581: guardians, advocates or author- ized representatives, providers, and other appro- priate individuals locally
p.000581: and across the State; and
p.000581: (ii) consider input from individuals with autism spectrum disorder and developmental disabilities and their
p.000581: family members, guardians, advocates or author- ized representatives, providers, and other appropriate
p.000581: individuals.
p.000581: (C) INFORMATION.—Information under subparagraph (A)(ii) shall be provided through—
p.000581: (i) toll-free telephone numbers;
p.000581: (ii) Internet websites;
p.000581: (iii) mailings; or
p.000581: (iv) such other means as the Governor may re- quire.
p.000581: (d) TOOLS.—
p.000581: (1) IN GENERAL.—To promote the use of valid and reliable screening tools for autism spectrum disorder and other
p.000581: devel- opmental disabilities, the Secretary shall develop a curriculum for continuing education to assist
p.000581: individuals in recognizing the need for valid and reliable screening tools and the use of such tools.
p.000581: (2) COLLECTION, STORAGE, COORDINATION, AND AVAIL- ABILITY.—The Secretary, in collaboration with the
p.000581: Secretary of Education, shall provide for the collection, storage, coordina- tion, and public availability of
p.000581: tools described in paragraph (1), educational materials and other products that are used by the Federal programs
p.000581: referred to in subsection (c)(1)(A), as well as—
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p.000581: (A) programs authorized under the Developmental Disabilities Assistance and Bill of Rights Act of 2000;
p.000581: (B) early intervention programs or interagency coordi- nating councils authorized under part C of the Individuals with
p.000581: Disabilities Education Act; and
p.000581: (C) children with special health care needs programs authorized under title V of the Social Security Act.
p.000581: (3) REQUIRED SHARING.—In establishing mechanisms and entities under this subsection, the Secretary, and the
p.000581: Secretary of Education, shall ensure the sharing of tools, materials, and products developed under this
p.000581: subsection among entities re- ceiving funding under this section.
p.000581: (e) DIAGNOSIS.—
p.000581: (1) TRAINING.—The Secretary, in coordination with activi- ties conducted under title V of the Social
p.000581: Security Act, shall, subject to the availability of appropriations, expand existing
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: avail- able to address overall health and wellness, and making pa- tient referrals to address tobacco
p.000595: cessation, good nutrition, and physical activity;
p.000595: (4) on when to refer patients to a health care provider with genetics expertise;
p.000595: (5) on how to provide counseling that addresses long-term survivorship and health concerns of young women
p.000595: diagnosed with breast cancer; and
p.000595: (6) on when to provide referrals to organizations and insti- tutions that provide credible health information
p.000595: and sub- stantive assistance and support to young women diagnosed with breast cancer.
p.000595: (c) PREVENTION RESEARCH ACTIVITIES.—The Secretary, acting through—
p.000595: (1) the Director of the Centers for Disease Control and Prevention, shall conduct prevention research on
p.000595: breast cancer in younger women, including—
p.000595: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000597: 597
p.000597: PUBLIC HEALTH SERVICE ACT
p.000597: Sec. 399NN
p.000597:
p.000597: (A) behavioral, survivorship studies, and other re- search on the impact of breast cancer diagnosis
p.000597: on young women;
p.000597: (B) formative research to assist with the development of educational messages and information for the
p.000597: public, targeted populations, and their families about breast health, breast cancer, and healthy
p.000597: lifestyles;
p.000597: (C) testing and evaluating existing and new social marketing strategies targeted at young women; and
p.000597: (D) surveys of health care providers and the public re- garding knowledge, attitudes, and practices related
p.000597: to breast health and breast cancer prevention and control in high-risk populations; and
p.000597: (2) the Director of the National Institutes of Health, shall conduct research to develop and validate
p.000597: new screening tests and methods for prevention and early detection of breast can- cer in young women.
p.000597: (d) SUPPORT FOR YOUNG WOMEN DIAGNOSED WITH BREAST CANCER.—
p.000597: (1) IN GENERAL.—The Secretary shall award grants to or- ganizations and institutions to provide health
p.000597: information from credible sources and substantive assistance directed to young women diagnosed with breast
p.000597: cancer and pre-neoplastic breast diseases.
p.000597: (2) PRIORITY.—In making grants under paragraph (1), the Secretary shall give priority to applicants that deal
p.000597: specifically with young women diagnosed with breast cancer and pre-neo- plastic breast disease.
...

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p.000605:
p.000605:
p.000607: 607
p.000607: PUBLIC HEALTH SERVICE ACT
p.000607: Sec. 402
p.000607:
p.000607:
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p.000607: January 30, 2020
p.000607: (11)(A) shall oversee research training for all of the na- tional research institutes and National
p.000607: Research Service Awards in accordance with section 487; and
p.000607: (B) may conduct and support research training—
p.000607: (i) for which fellowship support is not provided under section 487; and
p.000607: (ii) that does not consist of residency training of physi- cians or other health professionals;
p.000607: (12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that
p.000607: have not received significant funding relative to other matters, to re- spond to new issues and scientific
p.000607: emergencies, and to act on research opportunities of high priority;
p.000607: (13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray
p.000607: expenses for scientific, educational, and research-related conferences;
p.000607: (14) for the national research institutes and administrative entities within the National Institutes of Health—
p.000607: (A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and
p.000607: entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal
p.000607: property, and
p.000607: (B) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise
p.000607: through the Administrator of General Services, buildings or parts of buildings in the District of Columbia
p.000607: or communities lo- cated adjacent to the District of Columbia for use for a pe- riod not to exceed ten years;
p.000607: (15) may secure resources for research conducted by or through the National Institutes of Health;
p.000607: (16) may, without regard to the provisions of title 5, United States Code, governing appointments in
p.000607: the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such
p.000607: title relating to classifica- tion and General Schedule pay rates, establish such technical and scientific
p.000607: peer review groups and scientific program advi- sory committees as are needed to carry out the
p.000607: requirements of this title and appoint and pay the members of such groups, except that officers and employees of
p.000607: the United States shall not receive additional compensation for service as members of such groups;
p.000607: (17) may secure for the National Institutes of Health con- sultation services and advice of persons from the
...

p.000681: (B) may, in consultation with the advisory council for the Institute, make grants for construction or
p.000681: renovation of facili- ties; and
p.000681: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000681: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the Adminis- trator of General Services,
p.000681: buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of
p.000681: Columbia for the use of the Institute for a period not to exceed ten years;
p.000681: (7) may, in consultation with the advisory council for the Institute, appoint one or more advisory
p.000681: committees composed of such private citizens and officials of Federal, State, and local governments to advise the
p.000681: Director with respect to the Direc- tor’s functions;
p.000681: (8) may, subject to section 405(b)(2) and without regard to section 3324 of title 31, United States Code, and
p.000681: section 3709 of the Revised Statutes (41 U.S.C. 5), enter into such contracts, leases, cooperative agreements, as
p.000681: may be necessary in the conduct of functions of the Director, with any public agency, or
p.000681: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000681:
p.000681:
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p.000681:
p.000683: 683
p.000683: PUBLIC HEALTH SERVICE ACT
p.000683: Sec. 414
p.000683:
p.000683: with any person, firm, association, corporation, or educational institution; and
p.000683: (9) shall, notwithstanding section 405(a), prepare and sub- mit, directly to the President for review and
p.000683: transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel
p.000683: needs for the Institute) for the National Cancer Program, after reasonable opportunity for comment (but without
p.000683: change) by the Secretary, the Director of NIH, and the Institute’s advisory council.
p.000683: Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (5) shall be paid
p.000683: or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place
p.000683: of service and for other expenses associated with their assignment. Such expenses shall not be allowed
p.000683: in con- nection with the assignment of an expert or consultant whose serv- ices are obtained under paragraph (5)
p.000683: unless the expert or consult- ant has agreed in writing to complete the entire period of the as- signment
p.000683: or one year of the assignment, whichever is shorter, un- less separated or reassigned for reasons which are
p.000683: beyond the con- trol of the expert or consultant and which are acceptable to the Di- rector of the Institute. If
p.000683: the expert or consultant violates the agreement, the money spent by the United States for such ex-
p.000683: penses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive
p.000683: in whole or in part a right of recovery under the preceding sentence.
p.000683: (c) PRE-CLINICAL MODELS TO EVALUATE PROMISING PEDIATRIC CANCER THERAPIES.—
p.000683: (1) EXPANSION AND COORDINATION OF ACTIVITIES.—The Di- rector of the National Cancer Institute shall expand,
...

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p.000701: 701
p.000701: PUBLIC HEALTH SERVICE ACT
p.000701: Sec. 422
p.000701:
p.000701:
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p.000701:
p.000701:
p.000701: January 30, 2020
p.000701: (C) may, in consultation with the advisory council for the Institute, acquire, without regard to the Act
p.000701: of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Adminis- trator of General
p.000701: Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the
p.000701: District of Columbia for the use of the Institute for a period not to exceed ten years;
p.000701: (3) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
p.000701: and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such con- tracts, leases,
p.000701: cooperative agreements, or other transactions, as may be necessary in the conduct of the Director’s functions,
p.000701: with any public agency, or with any person, firm, association, corporation, or educational institutions;
p.000701: (4) may make grants to public and nonprofit private enti- ties to assist in meeting the cost of the care of
p.000701: patients in hos- pitals, clinics, and related facilities who are participating in re- search projects; and
p.000701: (5) shall, in consultation with the advisory council for the Institute, conduct appropriate intramural
p.000701: training and edu- cation programs, including continuing education and laboratory and clinical research training
p.000701: programs.
p.000701: Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (1) shall be paid
p.000701: or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place
p.000701: of service and for other expenses associated with their assignment. Such expenses shall not be allowed
p.000701: in con- nection with the assignment of an expert or consultant whose serv- ices are obtained under paragraph (1)
p.000701: unless the expert or consult- ant has agreed in writing to complete the entire period of the as- signment
p.000701: or one year of the assignment, whichever is shorter, un- less separated or reassigned for reasons which are
p.000701: beyond the con- trol of the expert or consultant and which are acceptable to the Di- rector of the Institute. If
p.000701: the expert or consultant violates the agreement, the money spent by the United States for such ex-
p.000701: penses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive
p.000701: in whole or in part a right of recovery under the preceding sentence.
...

p.000725: bladder and bowel incontinence, and adverse effects of prescription and over-the-counter medications, in such
p.000725: persons; and
p.000725: (2) model curricula for health care professionals, health care paraprofessionals, and family caregivers, for
p.000725: training and application in the use of such techniques.
p.000725: (e) For purposes of this section, the term ‘‘Council on Alz- heimer’s Disease’’ means the council established
p.000725: in section 911(a) 29 of Public Law 99–660.
p.000725: DISSEMINATION
p.000725: SEC. 445D. ø285e–6¿ The Director of the Institute shall dis- seminate the results of research conducted under
p.000725: section 445C and this section to appropriate professional entities and to the public.
p.000725: CLEARINGHOUSE ON ALZHEIMER’S DISEASE
p.000725: SEC. 445E. ø285e–7¿ (a) The Director of the Institute shall es- tablish the Clearinghouse on Alzheimer’s Disease
p.000725: (hereinafter re- ferred to as the ‘‘Clearinghouse’’). The purpose of the Clearinghouse is the dissemination of
p.000725: information concerning services available for individuals with Alzheimer’s disease and related dementias and their
p.000725: families. The Clearinghouse shall—
p.000725: (1) compile, archive, and disseminate information con- cerning research, demonstration, evaluation, and
p.000725: training pro- grams and projects concerning Alzheimer’s disease and related dementias; and
p.000725: (2) annually publish a summary of the information com- piled under paragraph (1) during the preceding
p.000725: 12-month pe- riod, and make such information available upon request to ap- propriate individuals and entities,
p.000725: including educational insti- tutions, research entities, and Federal and public agencies.
p.000725: (b) The Clearinghouse may charge an appropriate fee for infor- mation provided through the toll-free telephone
p.000725: line established under subsection (a)(3). 30
p.000725: (c) The Director of the Institute, the Director of the National Institute of Mental Health, and the Director
p.000725: of the National Center for Health Services Research and Health Care Technology Assess- ment shall provide to
p.000725: the Clearinghouse summaries of the findings of research conducted under part D.
p.000725: DISSEMINATION PROJECT
p.000725: SEC. 445F. ø285e–8¿ (a) The Director of the Institute shall make a grant to, or enter into a contract with, a
p.000725: national organiza- tion representing individuals with Alzheimer’s disease and related dementias for the
p.000725: conduct of the activities described in subsection (b).
p.000725:
p.000725:
p.000725:
p.000725:
p.000725: January 30, 2020
p.000725: 29 Section 911 was repealed by section 601(a)(2)(E) of Public Law 105–362 (112 Stat. 3286).
p.000725: 30 So in law. Section 445E does not contain a subsection (a)(3). Section 445F(b)(2) provides for a toll-free telephone
p.000725: line.
p.000725: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000725:
p.000725:
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p.000725:
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p.000727: 727
p.000727: PUBLIC HEALTH SERVICE ACT
p.000727: Sec. 445G
p.000727:
p.000727: (b) The organization receiving a grant or contract under this section shall—
p.000727: (1) establish a central computerized information system
p.000727: to—
...

p.000791: any individual whenever compliance by such individual is impossible or would in- volve substantial hardship to
p.000791: such individual or would be against equity and good conscience.
p.000791: INTRAMURAL LOAN REPAYMENT PROGRAM 54
p.000791: SEC. 487A. ø288–1¿ (a) IN GENERAL.—The Director of the Na- tional Institutes of Health shall, as appropriate and based
p.000791: on work- force and scientific priorities, carry out a program through the sub- categories listed in subsection
p.000791: (b)(1) (or modified subcategories as provided for in subsection (b)(2)) of entering into agreements with
p.000791: appropriately qualified health professionals under which such health professionals agree to conduct
p.000791: research, as employees of the National Institutes of Health, in consideration of the Federal Gov- ernment agreeing to
p.000791: repay, for each year of such service, not more
p.000791:
p.000791:
p.000791:
p.000791:
p.000791: January 30, 2020
p.000791: 54 The font/style of the section heading shown above conforms with the style of the original section
p.000791: heading for section 487A in all small caps centered heading. See typeface for the amend- ment made by section
p.000791: 2022(a)(1) of Public Law 114–255.
p.000791: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000791:
p.000791:
p.000791:
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p.000791:
p.000791:
p.000793: 793
p.000793: PUBLIC HEALTH SERVICE ACT
p.000793: Sec. 487B
p.000793:
p.000793: than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) general research;
p.000793: (ii) research on acquired immune deficiency syn- drome; and
p.000793: (iii) clinical research conducted by appropriately qualified health professional who are from disadvan-
p.000793: taged backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
p.000793: elimi- nate one or more subcategories provided for in paragraph (1) due to changes in workforce or
p.000793: scientific needs related to bio- medical research. The Director may establish other sub- category
p.000793: areas based on workforce and scientific priorities if the total number of subcategories does not exceed the
p.000793: number of subcategories listed in paragraph (1).
p.000793: (c) LIMITATION.—The Director of the National Institutes of Health may not enter into a contract with a
p.000793: health professional pursuant to subsection (a) unless such professional has a substan- tial amount of education
p.000793: loans relative to income (as determined pursuant to guidelines issued by the Director).
p.000793: (d) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan
p.000793: Repayment Program es- tablished in subpart III of part D of title III, the provisions of such subpart shall, except
...

p.000793: (e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for carrying out this section shall remain available until
p.000793: the expiration of the second fiscal year beginning after the fiscal year for which such amounts are made
p.000793: available.
p.000793: EXTRAMURAL LOAN REPAYMENT PROGRAM 55
p.000793: SEC. 487B. ø288–2¿ (a) IN GENERAL.—The Director of the Na- tional Institutes of Health shall, as appropriate and based
p.000793: on work- force and scientific priorities, carry out a program through the sub- categories listed in subsection
p.000793: (b)(1) (or modified subcategories as provided for in subsection (b)(2)), of entering into contracts with
p.000793: qualified health professionals under which such health profes- sionals agree to conduct research in
p.000793: consideration of the Federal Government agreeing to repay, for each year of such research, not
p.000793:
p.000793:
p.000793:
p.000793:
p.000793: January 30, 2020
p.000793: 55 The font/style of the section heading shown above conforms with the style of the original section
p.000793: heading for section 487B in all small caps centered heading. See typeface for the amend- ment made by section
p.000793: 2022(b)(1) of Public Law 114–255.
p.000793: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000793:
p.000793:
p.000793:
p.000793:
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p.000793:
p.000793: Sec. 487D PUBLIC HEALTH SERVICE ACT 794
p.000793:
p.000793: more than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) contraception or infertility research;
p.000793: (ii) pediatric research, including pediatric pharma- cological research;
p.000793: (iii) minority health disparities research;
p.000793: (iv) clinical research; and
p.000793: (v) clinical research conducted by appropriately qualified health professional who are from disadvan- taged
p.000793: backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
p.000793: elimi- nate one or more subcategories provided for in paragraph (1) due to changes in workforce or
p.000793: scientific needs related to bio- medical research. The Director may establish other sub- category
p.000793: areas based on workforce and scientific priorities if the total number of subcategories does not exceed the
p.000793: number of subcategories listed in paragraph (1).
p.000793: (c) LIMITATION.—The Director of the National Institutes of Health may not enter into a contract with a
p.000793: health professional pursuant to subsection (a) unless such professional has a substan- tial amount of education
p.000793: loans relative to income (as determined pursuant to guidelines issued by the Director).
...

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p.000795: January 30, 2020
p.000795: (A) are enrolled or accepted for enrollment as full-time undergraduates at accredited institutions of higher edu-
p.000795: cation; and
p.000795: (B) are from disadvantaged backgrounds.
p.000795: (b) FACILITATION OF INTEREST OF STUDENTS IN CAREERS AT NA- TIONAL INSTITUTES OF HEALTH.—In providing
p.000795: employment to indi- viduals pursuant to contracts under subsection (a)(1), the Director of NIH shall carry
p.000795: out activities to facilitate the interest of the in- dividuals in pursuing careers as employees of the National
p.000795: Insti- tutes of Health.
p.000795: (c) PERIOD OF OBLIGATED SERVICE.—
p.000795: (1) DURATION OF SERVICE.—For purposes of subparagraph
p.000795: (B) of subsection (a)(1), the period of service for which an indi- vidual is obligated to serve as an employee of the
p.000795: National In- stitutes of Health is, subject to paragraph (2)(A), 12 months for each academic year for which the
p.000795: scholarship under such sub- section is provided.
p.000795: (2) SCHEDULE FOR SERVICE.—
p.000795: (A) Subject to subparagraph (B), the Director of NIH may not provide a scholarship under subsection (a) unless
p.000795: the individual applying for the scholarship agrees that—
p.000795: (i) the individual will serve as an employee of the National Institutes of Health full-time for not less than
p.000795: 10 consecutive weeks of each year during which the individual is attending the educational institution
p.000795: involved and receiving such a scholarship;
p.000795: (ii) the period of service as such an employee that the individual is obligated to provide under clause (i) is
p.000795: in addition to the period of service as such an em- ployee that the individual is obligated to
p.000795: provide under subsection (a)(1)(B); and
p.000795: (iii) not later than 60 days after obtaining the educational degree involved, the individual will begin
p.000795: serving full-time as such an employee in satisfaction of the period of service that the individual is obligated to
p.000795: provide under subsection (a)(1)(B).
p.000795: (B) The Director of NIH may defer the obligation of an individual to provide a period of service under
p.000795: subsection (a)(1)(B), if the Director determines that such a deferral is appropriate.
p.000795: (3) APPLICABILITY OF CERTAIN PROVISIONS RELATING TO AP- POINTMENT AND COMPENSATION.—For any period in which
p.000795: an individual provides service as an employee of the National In- stitutes of Health in satisfaction of the
p.000795: obligation of the indi-
p.000795: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000795:
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p.000795: Sec. 488 PUBLIC HEALTH SERVICE ACT 796
p.000795:
p.000795: vidual under subsection (a)(1)(B) or paragraph (2)(A)(i), the in- dividual may be appointed as such an employee without
p.000795: regard to the provisions of title 5, United States Code, relating to ap- pointment and compensation.
p.000795: (d) PROVISIONS REGARDING SCHOLARSHIP.—
p.000795: (1) APPROVAL OF ACADEMIC PROGRAM.—The Director of NIH may not provide a scholarship under subsection (a)
p.000795: for an academic year unless—
p.000795: (A) the individual applying for the scholarship has submitted to the Director a proposed academic program for
p.000795: the year and the Director has approved the program; and
p.000795: (B) the individual agrees that the program will not be altered without the approval of the Director.
p.000795: (2) ACADEMIC STANDING.—The Director of NIH may not provide a scholarship under subsection (a) for an
p.000795: academic year unless the individual applying for the scholarship agrees to maintain an acceptable level of
p.000795: academic standing, as deter- mined by the educational institution involved in accordance with regulations issued
p.000795: by the Secretary.
p.000795: (3) LIMITATION ON AMOUNT.—The Director of NIH may not provide a scholarship under subsection (a) for an
p.000795: academic year in an amount exceeding $20,000.
p.000795: (4) AUTHORIZED USES.—A scholarship provided under sub- section (a) may be expended only for tuition
p.000795: expenses, other reasonable educational expenses, and reasonable living ex- penses incurred in attending
p.000795: the school involved.
p.000795: (5) CONTRACT REGARDING DIRECT PAYMENTS TO INSTITU- TION.—In the case of an institution of higher
p.000795: education with respect to which a scholarship under subsection (a) is provided, the Director of NIH may enter into a
p.000795: contract with the institu- tion under which the amounts provided in the scholarship for tuition and other
p.000795: educational expenses are paid directly to the institution.
p.000795: (e) PENALTIES FOR BREACH OF SCHOLARSHIP CONTRACT.—The provisions of section 338E shall apply to the
p.000795: program established in subsection (a) to the same extent and in the same manner as such provisions apply
p.000795: to the National Health Service Corps Loan Repayment Program established in section 338B.
p.000795: (f) REQUIREMENT OF APPLICATION.—The Director of NIH may not provide a scholarship under subsection
p.000795: (a) unless an applica- tion for the scholarship is submitted to the Director and the appli- cation is in such form,
p.000795: is made in such manner, and contains such agreements, assurances, and information as the Director deter- mines
p.000795: to be necessary to carry out this section.
p.000795: (g) AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— Amounts appropriated for a fiscal year for
p.000795: scholarships under this section shall remain available until the expiration of the second fis- cal year beginning
p.000795: after the fiscal year for which the amounts were appropriated.
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p.000795: January 30, 2020
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p.000795: VISITING SCIENTIST AWARDS
p.000795: SEC. 488. ø288a¿ (a) The Secretary may make awards (here- after in this section referred to as
p.000795: ‘‘Visiting Scientist Awards’’) to
p.000795: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000797: PUBLIC HEALTH SERVICE ACT
p.000797: Sec. 489
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p.000827: January 30, 2020
p.000827: (C) require that all grants that are awarded to entities other than States are awarded only after the State in
p.000827: which the entity intends to provide services—
p.000827: (i) is notified of the pendency of the grant applica- tion; and
p.000827: (ii) is afforded an opportunity to comment on the merits of the application; and
p.000827: (D) inform a State when any funds are awarded through such a grant to any entity within such State;
p.000827: (14) assure that services provided with amounts appro- priated under this title are provided bilingually, if
p.000827: appropriate;
p.000827: (15) improve coordination among prevention programs, treatment facilities and nonhealth care systems
p.000827: such as em- ployers, labor unions, and schools, and encourage the adoption of employee assistance programs and
p.000827: student assistance pro- grams;
p.000827: (16) maintain a clearinghouse for substance use disorder information, including evidence-based and promising
p.000827: best prac- tices for prevention, treatment, and recovery support services for individuals with mental and
p.000827: substance use disorders, to as- sure the widespread dissemination of such information to States,
p.000827: political subdivisions, educational agencies and institu- tions, treatment providers, and the general public;
p.000827: (17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug
p.000827: Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health,
p.000827: as appropriate, pro- mote and evaluate substance use disorder services for older Americans in need of such
p.000827: services, and mental health services for older Americans who are seriously mentally ill;
p.000827: (18) promote the coordination of service programs con- ducted by other departments, agencies, organizations and
p.000827: indi- viduals that are or may be related to the problems of individ- uals suffering from mental illness
p.000827: or substance abuse, includ- ing liaisons with the Social Security Administration, Centers for Medicare &
p.000827: Medicaid Services, and other programs of the Department, as well as liaisons with the Department of Edu-
p.000827: cation, Department of Justice, and other Federal Departments and offices, as appropriate;
p.000827: (19) consult with State, local, and tribal governments, non- governmental entities, and individuals with mental
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p.000837:
p.000837: (2) CONSULTATION.—In carrying out this section, the Lab- oratory shall consult with—
p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
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p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
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p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
p.000849: (A) the applicant has the capacity to carry out a pro- gram described in subsection (a);
p.000849: (B) the plans of the applicant for such a program are consistent with the policies of such agency
p.000849: regarding the treatment of substance use disorders; and
p.000849: (C) the applicant, or any entity through which the ap- plicant will provide authorized services, meets all applica- ble
p.000849: State licensure or certification requirements regarding the provision of the services involved.
p.000849: (2) STATUS AS MEDICAID PROVIDER.—
p.000849: (A) IN GENERAL.—Subject to subparagraphs (B) and (C), the Director may make an award under subsection (a) only
p.000849: if, in the case of any authorized service that is avail- able pursuant to the State plan approved under title
p.000849: XIX of the Social Security Act for the State involved—
p.000849: (i) the applicant for the award will provide the service directly, and the applicant has entered into a
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p.000857: adults who are at risk of substance use disorders;
p.000857: (2) providing substance use disorder treatment services for children, adolescents, and young adults, includingchildren,
p.000857: ado- lescents, and young adults with co-occurring mental illness and substance use disorders; and
p.000857: (3) providing assistance to pregnant women, and parenting women, with substance use disorders, in obtaining
p.000857: treatment services, linking mothers to community resources to support independent family lives, and staying
p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
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p.000859: (b) The Director of the Prevention Center shall—
p.000859: (1) sponsor regional workshops on the prevention of drug and alcohol abuse through the reduction of risk
p.000859: and the pro- motion of resiliency;
p.000859: (2) coordinate the findings of research sponsored by agen- cies of the Service on the prevention of drug and
p.000859: alcohol abuse;
p.000859: (3) collaborate with the Director of the National Institute on Drug Abuse, the Director of the National
p.000859: Institute on Alco- hol Abuse and Alcoholism, and States to promote the study of substance abuse prevention and the
p.000859: dissemination and imple- mentation of research findings that will improve the delivery and effectiveness of
p.000859: substance abuse prevention activities;
p.000859: (4) develop effective drug and alcohol abuse prevention lit- erature (including educational information on the
p.000859: effects of drugs abused by individuals, including drugs that are emerg- ing as abused drugs);
p.000859: (5) in cooperation with the Secretary of Education, assure the widespread dissemination of prevention
p.000859: materials among States, political subdivisions, and school systems;
p.000859: (6) support clinical training programs for health profes- sionals who provide substance use and misuse
p.000859: prevention and treatment services and other health professionals involved in illicit drug use education and
p.000859: prevention;
p.000859: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000861: PUBLIC HEALTH SERVICE ACT
p.000861: Sec. 516
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p.000861: (10) collaborate with the Attorney General of the Depart- ment of Justice to develop programs to prevent
p.000861: drug abuse among high risk youth;
p.000861: (11) prepare for distribution documentary films and public service announcements for television and radio to
p.000861: educate the public, especially adolescent audiences, concerning the dangers to health resulting from the consumption
p.000861: of alcohol and drugs and, to the extent feasible, use appropriate private organiza- tions and business
p.000861: concerns in the preparation of such an- nouncements;
p.000861: (12) develop and support innovative demonstration pro- grams designed to identify and deter the improper
p.000861: use or abuse of anabolic steroids by students, especially students in secondary schools;
p.000861: (13) ensure the consistent documentation of the application of criteria when awarding grants and the ongoing oversight
p.000861: of grantees after such grants are awarded;
p.000861: (14) assist and support States in preventing illicit drug use, including emerging illicit drug use issues; and
p.000861: (15) in consultation with relevant stakeholders and in col- laboration with the Director of the Centers for Disease
p.000861: Control and Prevention, develop educational materials for clinicians to use with pregnant women for shared
p.000861: decision making regard- ing pain management and the prevention of substance use dis- orders during pregnancy.
p.000861: (c) The Director may make grants and enter into contracts and cooperative agreements in carrying out subsection (b).
p.000861: (d) The Director of the Prevention Center shall establish a na- tional data base providing information on programs for
p.000861: the preven- tion of substance abuse. The data base shall contain information appropriate for use by public
p.000861: entities and information appropriate for use by nonprofit private entities.
p.000861: SEC. 516. ø290bb–22¿ PRIORITY SUBSTANCE USE DISORDER PREVEN- TION NEEDS OF REGIONAL AND NATIONAL
p.000861: SIGNIFI- CANCE.
p.000861: (a) PROJECTS.—The Secretary shall address priority substance use disorder prevention needs of regional and
p.000861: national significance (as determined under subsection (b)) through the provision of or through assistance for—
p.000861: (1) knowledge development and application projects for prevention and the conduct or support of
p.000861: evaluations of such projects;
p.000861: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000877: øSection 520D was repealed by section 9017 of Public Law 114–255.¿
p.000877: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: PUBLIC HEALTH SERVICE ACT
p.000879: Sec. 520E
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p.000879: January 30, 2020
p.000879: SEC. 520E. ø290bb–36¿ YOUTH SUICIDE EARLY INTERVENTION AND PREVENTION STRATEGIES.
p.000879: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Mental Health and Substance
p.000879: Use, shall award grants or cooperative agreements to eligible entities to—
p.000879: (1) develop and implement State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention strate- gies in schools, educational institutions, juvenile justice sys- tems, substance use
p.000879: disorder programs, mental health pro- grams, foster care systems, and other child and youth support organizations;
p.000879: (2) support public organizations and private nonprofit or- ganizations actively involved in State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies and in the development
p.000879: and continuation of State-spon- sored statewide youth suicide early intervention and preven- tion strategies;
p.000879: (3) provide grants to institutions of higher education to co- ordinate the implementation of State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strate- gies;
p.000879: (4) collect and analyze data on State-sponsored statewide or tribal youth suicide early intervention and
p.000879: prevention serv- ices that can be used to monitor the effectiveness of such serv- ices and for research, technical
p.000879: assistance, and policy develop- ment; and
p.000879: (5) assist eligible entities, through State-sponsored state- wide or tribal youth suicide early
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p.000879: the extent of the need of the applicant, including the incidence and preva- lence of suicide in the
p.000879: State and among the populations of focus, including rates of suicide determined by the Centers for Disease
p.000879: Control and Prevention for the State or population of focus.
p.000879: (c) PREFERENCE.—In providing assistance under a grant or co- operative agreement under this section, an eligible entity
p.000879: shall give preference to public organizations, private nonprofit organizations, political subdivisions,
p.000879: institutions of higher education, and tribal organizations actively involved with the State-sponsored
p.000879: statewide or tribal youth suicide early intervention and prevention strategy that—
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p.000879: (1) provide early intervention and assessment services, in- cluding screening programs, to youth who are at risk for
p.000879: men- tal or emotional disorders that may lead to a suicide attempt, and that are integrated with school
p.000879: systems, educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health
p.000879: programs, foster care systems, and other child and youth support organizations;
p.000879: (2) demonstrate collaboration among early intervention and prevention services or certify that entities
p.000879: will engage in future collaboration;
p.000879: (3) employ or include in their applications a commitment to evaluate youth suicide early intervention and
p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
p.000881:
p.000881: that child-serving professionals and providers involved in early intervention and prevention services are properly
p.000881: trained in ef- fectively identifying youth who are at risk for suicide;
p.000881: (11) provide continuous training activities for child care professionals and community care providers on the
p.000881: latest youth suicide early intervention and prevention services practices and strategies;
p.000881: (12) conduct annual self-evaluations of outcomes and ac- tivities, including consulting with interested families
p.000881: and advo- cacy organizations;
...

p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
p.000883: (1) EARLY INTERVENTION.—The term ‘‘early intervention’’ means a strategy or approach that is intended to
p.000883: prevent an outcome or to alter the course of an existing condition.
p.000883: (2) EDUCATIONAL INSTITUTION; INSTITUTION OF HIGHER EDUCATION; SCHOOL.—The term—
p.000883: (A) ‘‘educational institution’’ means a school or institu- tion of higher education;
p.000883: (B) ‘‘institution of higher education’’ has the meaning given such term in section 101 of the Higher
p.000883: Education Act of 1965; and
p.000883: (C) ‘‘school’’ means an elementary school or secondary school (as such terms are defined in section 8101 of the
p.000883: El- ementary and Secondary Education Act of 1965).
p.000883: (3) PREVENTION.—The term ‘‘prevention’’ means a strategy or approach that reduces the likelihood or risk of
p.000883: onset, or delays the onset, of adverse health problems that have been known to lead to suicide.
p.000883: (4) YOUTH.—The term ‘‘youth’’ means individuals who are between 10 and 24 years of age.
p.000883: (m) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000883: to be appropriated
p.000883: $30,000,000 for each of fiscal years 2018 through 2022.
p.000883: SEC. 520E–1. ø290bb–36a¿ SUICIDE PREVENTION FOR CHILDREN AND ADOLESCENTS 10.
p.000883: (a) IN GENERAL.—The Secretary shall award grants or cooperative agreements to public organizations,
...

p.000885: grant or cooperative agreement under sub- section (a) shall prepare and submit to the Secretary at the end of the
p.000885: program period, an evaluation of all activities funded under this section.
p.000885: (j) DISSEMINATION AND EDUCATION.—The Secretary shall en- sure that findings derived from activities
p.000885: carried out under this section are disseminated to State, county and local governmental agencies and
p.000885: public and private nonprofit organizations active in promoting suicide prevention and family support activities.
p.000885: (k) DURATION OF PROJECTS.—With respect to a grant, contract, or cooperative agreement 12 awarded under this
p.000885: section, the period during which payments under such award may be made to the re- cipient may not exceed 3 years.
p.000885: (l) STUDY.—Within 1 year after the date of the enactment of this section, the Secretary shall, directly
p.000885: or by grant or contract, initiate a study to assemble and analyze data to identify—
p.000885: (1) unique profiles of children under 13 who attempt or complete suicide;
p.000885: (2) unique profiles of youths between ages 13 and 24 who attempt or complete suicide; and
p.000885: (3) a profile of services available to these groups and the use of these services by children and
p.000885: youths from paragraphs
p.000885: (1) and (2).
p.000885: (m) DEFINITIONS.—In this section, the terms ‘‘early interven- tion’’, ‘‘educational institution’’,
p.000885: ‘‘institution of higher education’’, ‘‘prevention’’, ‘‘school’’, and ‘‘youth’’ have the meanings given to
p.000885: those terms in section 520E.
p.000885: (n) AUTHORIZATION OF APPROPRIATION.—For purposes of car- rying out this section, there is
p.000885: authorized to be appropriated
p.000885: $75,000,000 for fiscal year 2001 and such sums as may be nec- essary for each of the fiscal years 2002
p.000885: through 2003.
p.000885:
p.000885:
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p.000885: January 30, 2020
p.000885: 12 So in law. Probably should be ‘‘grant or cooperative agreement’’. See the amendments made by section 3(b) of Public
p.000885: Law 108–355 (118 Stat. 1407).
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000885: Sec. 520E–2 PUBLIC HEALTH SERVICE ACT 886
p.000885:
p.000885: SEC. 520E–2. ø290bb–36b¿ MENTAL HEALTH AND SUBSTANCE USE DIS- ORDER SERVICES ON CAMPUS.
p.000885: (a) IN GENERAL.—The Secretary, acting through the Director of the Center for Mental Health Services and in consultation
...

p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000917: Sec. 547A PUBLIC HEALTH SERVICE ACT 918
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p.000917: January 30, 2020
p.000917:
p.000917: (c) FEDERAL SHARE.—The Federal share of the costs of a pro- gram funded by a grant under this section may not
p.000917: exceed 85 per- cent.
p.000917: (d) USE OF FUNDS.—Grants awarded under subsection (b)—
p.000917: (1) shall be used to develop, expand, and enhance commu- nity and statewide recovery support services; and
p.000917: (2) may be used to—
p.000917: (A) build connections between recovery networks, in- cluding between recovery community organizations and
p.000917: peer support networks, and with other recovery support services, including—
p.000917: (i) behavioral health providers;
p.000917: (ii) primary care providers and physicians;
p.000917: (iii) educational and vocational schools;
p.000917: (iv) employers;
p.000917: (v) housing services;
p.000917: (vi) child welfare agencies; and
p.000917: (vii) other recovery support services that facilitate recovery from substance use disorders, including non-
p.000917: clinical community services;
p.000917: (B) reduce stigma associated with substance use dis- orders; and
p.000917: (C) conduct outreach on issues relating to substance use disorders and recovery, including—
p.000917: (i) identifying the signs of substance use disorder;
p.000917: (ii) the resources available to individuals with substance use disorder and to families of an individual
p.000917: with a substance use disorder, including programs that mentor and provide support services to children;
p.000917: (iii) the resources available to help support indi- viduals in recovery; and
p.000917: (iv) related medical outcomes of substance use dis- orders, the potential of acquiring an infection com- monly
p.000917: associated with illicit drug use, and neonatal abstinence syndrome among infants exposed to opioids during
p.000917: pregnancy.
...

p.000921: (c) COMPOSITION.—The working group convened under sub- section (b) shall include—
p.000921: (1) mental health consumers, including students and fam- ily members;
p.000921: (2) representatives of institutions of higher education;
p.000921: (3) representatives of national mental and behavioral health associations and associations of
p.000921: institutions of higher education;
p.000921: (4) representatives of health promotion and prevention or- ganizations at institutions of higher education;
p.000921: (5) representatives of mental health providers, including community mental health centers; and
p.000921: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000923: PUBLIC HEALTH SERVICE ACT
p.000923: Sec. 550
p.000923:
p.000923: (6) representatives of private-sector and public-sector groups with experience in the development of
p.000923: effective public health education campaigns.
p.000923: (d) PLAN.—The working group under subsection (b) shall de- velop a plan that—
p.000923: (1) targets promotional and educational efforts to the age population of students at institutions of
p.000923: higher education and individuals who are employed in settings of institutions of higher education, including
p.000923: through the use of roundtables;
p.000923: (2) develops and proposes the implementation of research- based public health messages and activities;
p.000923: (3) provides support for local efforts to reduce stigma by using the National Health Information Center
p.000923: as a primary point of contact for information, publications, and service pro- gram referrals; and
p.000923: (4) develops and proposes the implementation of a social marketing campaign that is targeted at the
p.000923: population of stu- dents attending institutions of higher education and individ- uals who are employed in
p.000923: settings of institutions of higher edu- cation.
p.000923: (e) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000923: section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001).
p.000923: (f) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $1,000,000
...

p.000927: into the workforce; and
p.000927: (x) other best practices to provide the full con- tinuum of treatment and services, as determined by the
p.000927: Secretary.
p.000927: (C) Ensure that all programs covered by the Center in- clude medication-assisted treatment, as appropriate, and do
p.000927: not exclude individuals receiving medication-assisted treatment from any service.
p.000927: (D) Periodically conduct patient assessments to sup- port sustained and clinically significant recovery, as
p.000927: de- fined by the Assistant Secretary for Mental Health and Substance Use.
p.000927: (E) Provide onsite access to medication, as appro- priate, and toxicology services; for purposes of
p.000927: carrying out this section.
p.000927: (F) Operate a secure, confidential, and interoperable electronic health information system.
p.000927: (G) Offer family support services such as child care, family counseling, and parenting interventions to help
p.000927: sta- bilize families impacted by substance use disorder, as ap- propriate.
p.000927: (2) OUTREACH.—Each Center shall carry out outreach ac- tivities regarding the services offered through the
p.000927: Centers, which may include—
p.000927: (A) training and supervising outreach staff, as appro- priate, to work with State and local health
p.000927: departments, health care providers, the Indian Health Service, State and local educational agencies, schools
p.000927: funded by the In- dian Bureau of Education, institutions of higher education, State and local workforce
p.000927: development boards, State and local community action agencies, public safety officials, first responders,
p.000927: Indian Tribes, child welfare agencies, as appropriate, and other community partners and the public, including
p.000927: patients, to identify and respond to community needs;
p.000927: (B) ensuring that the entities described in subpara- graph (A) are aware of the services of the Center; and
p.000927: (C) disseminating and making publicly available, in- cluding through the internet, evidence-based
p.000927: resources that educate professionals and the public on opioid use dis- order and other substance use disorders,
p.000927: including co-oc- curring substance use and mental disorders.
p.000927: (h) DATA REPORTING AND PROGRAM OVERSIGHT.—With respect to a grant awarded under subsection (a), not later
p.000927: than 90 days after the end of the first year of the grant period, and annually thereafter for the
p.000927: duration of the grant period (including the dura- tion of any renewal period for such grant), the entity shall submit
p.000927: data, as appropriate, to the Secretary regarding—
p.000927: (1) the programs and activities funded by the grant;
...

p.000931: system;
p.000931: (C) be established pursuant to agreements that the public entity enters into with the agencies and entities de-
p.000931: scribed in subparagraph (B);
p.000931: (D) coordinate the provision of the services of the sys- tem; and
p.000931: (E) establish an office whose functions are to serve as the location through which children are provided access to the
p.000931: system, to coordinate the provision of services of the system, and to provide information to the public
p.000931: regarding the system.
p.000931: (3) COLLABORATION OF LOCAL PUBLIC ENTITIES.—A funding agreement for a grant under section 561(a) is that,
p.000931: for pur- poses of the establishment and operation of a system of care under paragraph (1), the public
p.000931: entity involved will seek col- laboration among all public agencies that provide human serv- ices in the
p.000931: community in which the system is established, in- cluding but not limited to those providing mental
p.000931: health serv-
p.000931: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
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p.000933: (C) services available under other appropriate pro- grams, as identified by the Secretary.
p.000933: (e) GENERAL PROVISIONS REGARDING SERVICES OF SYSTEM.—
p.000933: (1) CASE MANAGEMENT SERVICES.—A funding agreement for a grant under section 561(a) is that a system of care
p.000933: under subsection (a) will provide for the case management of each child provided access to the system in
p.000933: order to ensure that—
p.000933: (A) the services provided through the system to the child are coordinated and that the need of each such child
p.000933: for the services is periodically reassessed;
p.000933: (B) information is provided to the family of the child on the extent of progress being made toward the
p.000933: objectives established for the child under the plan of services imple- mented for the child pursuant to
p.000933: section 563; and
p.000933: (C) the system provides assistance with respect to—
p.000933: (i) establishing the eligibility of the child, and the family of the child, for financial assistance and serv-
p.000933: ices under Federal, State, or local programs providing for health services, mental health services, educational
p.000933: services, social services, or other services; and
p.000933: (ii) seeking to ensure that the child receives ap- propriate services available under such programs.
p.000933: (2) OTHER PROVISIONS.—A funding agreement for a grant under section 561(a) is that a system of care under
p.000933: subsection (a), in providing the services of the system, will—
p.000933: (A) provide the services of the system in the cultural context that is most appropriate for the child
p.000933: and family involved;
p.000933: (B) ensure that individuals providing such services to the child can effectively communicate with the
p.000933: child and family in the most direct manner;
p.000933: (C) provide the services without discriminating against the child or the family of the child on the basis of race, re-
p.000933: ligion, national origin, sex, disability, or age;
p.000933: (D) seek to ensure that each child provided access to the system of care remains in the least
...

p.000933: SEC. 563. ø290ff–2¿ INDIVIDUALIZED PLAN FOR SERVICES.
p.000933: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 561(a) is that a system of care under
p.000933: section 562(a) will de- velop and carry out an individualized plan of services for each child provided access to the
p.000933: system, and that the plan will be developed and carried out with the participation of the family of the
p.000933: child and, unless clinically inappropriate, with the participation of the child.
p.000933: (b) MULTIDISCIPLINARY TEAM.—A funding agreement for a grant under section 561(a) is that the plan
p.000933: required in subsection
p.000933: (a) will be developed, and reviewed and as appropriate revised not less than once each year, by a
p.000933: multidisciplinary team of appro- priately qualified individuals who provide services through the sys- tem,
p.000933: including as appropriate mental health services, other health
p.000933:
p.000933: January 30, 2020 As Amended Through P.L. 116-94,
p.000933: Enacted December 20, 2019
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p.000935: PUBLIC HEALTH SERVICE ACT
p.000935: Sec. 564
p.000935:
p.000935: services, educational services, social services, and vocational coun- seling and rehabilitation; 16
p.000935: (c) COORDINATION WITH SERVICES UNDER INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—A funding agreement
p.000935: for a grant under section 561(a) is that, with respect to a plan under sub- section (a) for a child,
p.000935: the multidisciplinary team required in sub- section (b) will—
p.000935: (1) in developing, carrying out, reviewing, and revising the plan consider any individualized education program
p.000935: in effect for the child pursuant to part B of the Individuals with Dis- abilities Education Act;
p.000935: (2) ensure that the plan is consistent with such individual- ized education program and provides for coordinating
p.000935: services under the plan with services under such program; and
p.000935: (3) ensure that the memorandum of understanding entered into under section 562(d)(3)(B) regarding such Act
p.000935: includes provisions regarding compliance with this subsection.
p.000935: (d) CONTENTS OF PLAN.—A funding agreement for a grant under section 561(a) is that the plan required in
p.000935: subsection (a) for a child will—
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p.000939: development of children;
p.000939: (2) provide technical assistance to local communities with respect to the development of programs described in
p.000939: paragraph (1);
p.000939: (3) provide assistance to local communities in the develop- ment of policies to address violence when and if it occurs;
p.000939: (4) assist in the creation of community partnerships among law enforcement, education systems and mental health
p.000939: and substance abuse service systems; and
p.000939: (5) establish mechanisms for children and adolescents to report incidents of violence or plans by other
p.000939: children or ado- lescents to commit violence.
p.000939: (c) REQUIREMENTS.—An application for a grant, contract or co- operative agreement under subsection (a) shall
p.000939: demonstrate that—
p.000939: (1) the applicant will use amounts received to create a partnership described in subsection (b)(4) to
p.000939: address issues of violence in schools;
p.000939: (2) the activities carried out by the applicant will provide a comprehensive method for addressing
p.000939: violence, that will in- clude—
p.000939: (A) security;
p.000939: (B) educational reform;
p.000939: (C) the review and updating of school policies;
p.000939: (D) alcohol and drug abuse prevention and early inter- vention services;
p.000939: (E) mental health prevention and treatment services;
p.000939: and
p.000939: (F) early childhood development and psychosocial serv-
p.000939: ices; and
p.000939: (3) the applicant will use amounts received only for the services described in subparagraphs (D), (E),
p.000939: and (F) of para- graph (2).
p.000939: (d) GEOGRAPHICAL DISTRIBUTION.—The Secretary shall ensure that grants, contracts or cooperative agreements
p.000939: under subsection
p.000939:
p.000939: 18 The part designation and heading for part F are so in law. Part F formerly consisted of section
p.000939: 571. That section was repealed by section 3301(c)(4) of Public Law 106–310 (114 Stat. 1209), but there
p.000939: was no conforming amendment to strike the designation and heading for part F.
p.000939:
p.000939:
p.000939: January 30, 2020
p.000939: 19 There is another part G in this title, which also begins with a section 581. See page 677. That
p.000939: part G relates to services provided through religious organizations.
p.000939: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000949: (1) IN GENERAL.—Except as provided in paragraph (2), any religious organization that is a program participant
p.000949: shall be subject to the same regulations as other recipients of awards of Federal financial assistance to
p.000949: account, in accordance with generally accepted auditing principles, for the use of the funds provided under such
p.000949: awards.
p.000949: (2) LIMITED AUDIT.—With respect to the award involved, a religious organization that is a program participant
p.000949: shall seg- regate Federal amounts provided under award into a separate account from non-Federal funds. Only the award
p.000949: funds shall be subject to audit by the government.
p.000949: (h) COMPLIANCE.—With respect to compliance with this section by an agency, a religious organization may obtain
p.000949: judicial review of agency action in accordance with chapter 7 of title 5, United States Code.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000949: Sec. 583 PUBLIC HEALTH SERVICE ACT 950
p.000949:
p.000949: SEC. 583. ø290kk–2¿ LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.
p.000949: No funds provided under a designated program shall be ex- pended for sectarian worship, instruction, or
p.000949: proselytization.
p.000949: SEC. 584. ø290kk–3¿ EDUCATIONAL REQUIREMENTS FOR PERSONNEL IN DRUG TREATMENT PROGRAMS.
p.000949: (a) FINDINGS.—The Congress finds that—
p.000949: (1) establishing unduly rigid or uniform educational quali- fication for counselors and other personnel in drug
p.000949: treatment programs may undermine the effectiveness of such programs; and
p.000949: (2) such educational requirements for counselors and other personnel may hinder or prevent the provision of needed drug
p.000949: treatment services.
p.000949: (b) NONDISCRIMINATION.—In determining whether personnel of a program participant that has a record of
p.000949: successful drug treat- ment for the preceding three years have satisfied State or local re- quirements for education
p.000949: and training, a State or local government shall not discriminate against education and training provided to
p.000949: such personnel by a religious organization, so long as such edu- cation and training includes basic content
p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
p.000949:
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
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p.000975: paid and the ceiling shall be carried over
p.000975: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000977: 977
p.000977: PUBLIC HEALTH SERVICE ACT
p.000977: Sec. 702
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p.000977: January 30, 2020
p.000977: to the next fiscal year and added to the ceiling applicable to that fiscal year, and if in any fiscal year
p.000977: no ceiling has been established, any difference carried over shall constitute the ceiling for making new
p.000977: loans (including loans to new borrowers) and paying install- ments for such fiscal year. Thereafter, Federal
p.000977: loan insurance pur- suant to this subpart may be granted only for loans made (or for loan installments
p.000977: paid pursuant to lines of credit) to enable stu- dents, who have obtained prior loans insured under
p.000977: this subpart, to continue or complete their educational program or to obtain a loan under section
p.000977: 705(a)(1)(B) to pay interest on such prior loans; but no insurance may be granted for any loan made or installment paid
p.000977: after September 30, 1998. The total principal amount of Fed- eral loan insurance available under this subsection shall
p.000977: be grant- ed by the Secretary without regard to any apportionment for the purpose of chapter 15 of title 31,
p.000977: United States Code, and without regard to any similar limitation.
p.000977: (b) CERTAIN LIMITATIONS AND PRIORITIES.—
p.000977: (1) LIMITATIONS REGARDING LENDERS, STATES, OR AREAS.— The Secretary may, if necessary to assure an equitable
p.000977: dis- tribution of the benefits of this subpart, assign, within the maximum amounts specified in subsection
p.000977: (a), Federal loan in- surance quotas applicable to eligible lenders, or to States or areas, and may from time
p.000977: to time reassign unused portions of these quotas.
p.000977: (2) PRIORITY FOR CERTAIN LENDERS.—In providing certifi- cates of insurance under section 706 through
p.000977: comprehensive contracts, the Secretary shall give priority to eligible lenders that agree—
p.000977: (A) to make loans to students at interest rates below the rates prevailing, during the period involved,
p.000977: for loans covered by Federal loan insurance pursuant to this sub- part; or
p.000977: (B) to make such loans under terms that are otherwise favorable to the student relative to the terms under which
p.000977: eligible lenders are generally making such loans during such period.
p.000977: (c) AUTHORITY OF STUDENT LOAN MARKETING ASSOCIATION.—
...

p.000977: required to be paid under the provisions of section 707 or 714.
p.000977: SEC. 704. ø292c¿ SOURCES OF FUNDS.
p.000977: Loans made by eligible lenders in accordance with this subpart shall be insurable by the Secretary whether made from
p.000977: funds fully owned by the lender or from funds held by the lender in a trust or similar capacity and
p.000977: available for such loans.
p.000977: SEC. 705. ø292d¿ ELIGIBILITY OF BORROWERS AND TERMS OF IN- SURED LOANS.
p.000977: (a) IN GENERAL.—A loan by an eligible lender shall be insur- able by the Secretary under the provisions of
p.000977: this subpart only if—
p.000977: (1) made to—
p.000977: (A) a student who—
p.000977: (i)(I) has been accepted for enrollment at an eligi- ble institution, or (II) in the case of a student attend-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000977:
p.000979: 979
p.000979: PUBLIC HEALTH SERVICE ACT
p.000979: Sec. 705
p.000979:
p.000979: ing an eligible institution, is in good standing at that institution, as determined by the institution;
p.000979: (ii) is or will be a full-time student at the eligible institution;
p.000979: (iii) has agreed that all funds received under such loan shall be used solely for tuition, other reasonable
p.000979: educational expenses, including fees, books, and lab- oratory expenses, and reasonable living expenses, in-
p.000979: curred by such students;
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section; and
p.000979: (v) in the case of a pharmacy student, has satis- factorily completed three years of training; or
p.000979: (B) an individual who—
p.000979: (i) has previously had a loan insured under this subpart when the individual was a full-time student at an
p.000979: eligible institution;
p.000979: (ii) is in a period during which, pursuant to para- graph (2), the principal amount of such previous loan need
p.000979: not be paid;
p.000979: (iii) has agreed that all funds received under the proposed loan shall be used solely for repayment of in-
p.000979: terest due on previous loans made under this subpart; and
p.000979: (iv) if required under section 3 of the Military Se- lective Service Act to present himself for and submit to
p.000979: registration under such section, has presented him- self and submitted to registration under such section;
p.000979: (2) evidenced by a note or other written agreement which—
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p.000979: than four years in duration;
p.000979: (II) the borrower completes the fourth year of an accredited internship or residency program of more than four
p.000979: years in duration; or
p.000979: (III) the borrower, if not a participant in a program described in subclause (I) or (II), ceases to
p.000979: carry, at an eligible institution, the normal full-
p.000979: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000979: Sec. 705 PUBLIC HEALTH SERVICE ACT 980
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p.000979: time academic workload as determined by the in- stitution; or
p.000979: (ii) the date on which a borrower who is a grad- uate of an eligible institution ceases to be a
p.000979: partici- pant in a fellowship training program not in excess of two years or a participant in a full-time
p.000979: educational activity not in excess of two years, which—
p.000979: (I) is directly related to the health profession for which the borrower prepared at an eligible in- stitution,
p.000979: as determined by the Secretary; and
p.000979: (II) may be engaged in by the borrower during such a two-year period which begins within twelve months after the
p.000979: completion of the borrower’s par- ticipation in a program described in subclause (I) or (II) of clause (i) or
p.000979: prior to the completion of the borrower’s participation in such program,
p.000979: except as provided in subparagraph (C), except that the period of the loan may not exceed 33 years
p.000979: from the date of execution of the note or written agreement evidencing it, and except that the note or other written
p.000979: instrument may contain such provisions relating to repayment in the event of default in the payment of interest or in
p.000979: the payment of the costs of insurance premiums, or other default by the borrower, as may be authorized by
p.000979: regulations of the Sec- retary in effect at the time the loan is made;
p.000979: (C) provides that periodic installments of principal and interest need not be paid, but interest shall accrue, during
p.000979: any period (i) during which the borrower is pursuing a full-time course of study at an eligible institution
p.000979: (or at an institution defined by section 102(a) of the Higher Edu- cation Act of 1965); (ii) not in
p.000979: excess of four years during which the borrower is a participant in an accredited in- ternship or
p.000979: residency program (including any period in such a program described in subclause (I) or subclause (II) of
p.000979: subparagraph (B)(i)); (iii) not in excess of three years, during which the borrower is a member of the
...

p.000997: (i) repayable monthly and in default for at least 120 days; and
p.000997: (ii) repayable less frequently than monthly and in default for at least 180 days;
p.000997: (C) The term ‘‘grace period’’ means the period of one year beginning on the date on which the borrower
p.000997: ceases to pursue a full-time course of study at a school of medi- cine, osteopathic medicine, dentistry,
p.000997: pharmacy, podiatric medicine, optometry, or veterinary medicine; and
p.000997: (D) The term ‘‘matured loans’’ means the total prin- cipal amount of all loans made by a school under this sub-
p.000997: part minus the total principal amount of loans made by such school to students who are—
p.000997: (i) enrolled in a full-time course of study at such school; or
p.000997: (ii) in their grace period.
p.000997: SEC. 722. ø292r¿ LOAN PROVISIONS.
p.000997: (a) AMOUNT OF LOAN.—
p.000997: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000997:
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p.000997: Sec. 722 PUBLIC HEALTH SERVICE ACT 998
p.000997:
p.000997: (1) IN GENERAL.—Loans from a student loan fund (estab- lished under an agreement with a school under
p.000997: section 721) may not, subject to paragraph (2), exceed for any student for a school year (or its equivalent)
p.000997: the cost of attendance (includ- ing tuition, other reasonable educational expenses, and reason- able living costs) for
p.000997: that year at the educational institution at- tended by the student (as determined by such educational in-
p.000997: stitution).
p.000997: (2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For purposes of paragraph (1), the amount of the loan may,
p.000997: in the case of the third or fourth year of a student at a school of med- icine or osteopathic medicine, be
p.000997: increased to the extent nec- essary to pay the balances of loans that, from sources other than the
p.000997: student loan fund under section 721, were made to the individual for attendance at the school. The
p.000997: authority to make such an increase is subject to the school and the student agreeing that such amount (as
p.000997: increased) will be expended to pay such balances.
p.000997: (b) TERMS AND CONDITIONS.—Subject to section 723, any such loans shall be made on such terms and
p.000997: conditions as the school may determine, but may be made only to a student—
p.000997: (1) who is in need of the amount thereof to pursue a full- time course of study at the school leading to a
p.000997: degree of doctor of medicine, doctor of dentistry or an equivalent degree, doctor of osteopathy, bachelor of science in
p.000997: pharmacy or an equivalent degree, doctor of pharmacy or an equivalent degree, doctor of podiatric medicine or
p.000997: an equivalent degree, doctor of optometry or an equivalent degree, or doctor of veterinary medicine or an equivalent
p.000997: degree; and
p.000997: (2) who, if required under section 3 of the Military Selec- tive Service Act to present himself for
...

p.000997: ceases to pursue a full-time course of study at a school of med- icine, osteopathic medicine, dentistry, pharmacy,
p.000997: podiatry, optom- etry, or veterinary medicine, excluding from such period—
p.000997: (1) all periods—
p.000997: (A) not in excess of three years of active duty per- formed by the borrower as a member of a uniformed serv-
p.000997: ice;
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p.000997: (B) not in excess of three years during which the bor- rower serves as a volunteer under the Peace Corps Act;
p.000997: (C) during which the borrower participates in ad- vanced professional training, including
p.000997: internships and residencies; and
p.000997: (D) during which the borrower is pursuing a full-time course of study at such a school; and
p.000997: (2) a period—
p.000997: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000999: 999
p.000999: PUBLIC HEALTH SERVICE ACT
p.000999: Sec. 722
p.000999:
p.000999: (A) not in excess of two years during which a borrower who is a full-time student in such a school leaves the
p.000999: school, with the intent to return to such school as a full- time student, in order to engage in a full-time
p.000999: educational activity which is directly related to the health profession for which the borrower is preparing, as
p.000999: determined by the Secretary; or
p.000999: (B) not in excess of two years during which a borrower who is a graduate of such a school is a participant in a fel-
p.000999: lowship training program or a full-time educational activ- ity which—
p.000999: (i) is directly related to the health profession for which such borrower prepared at such school, as deter-
p.000999: mined by the Secretary; and
p.000999: (ii) may be engaged in by the borrower during such a two-year period which begins within twelve months
p.000999: after the completion of the borrower’s partici- pation in advanced professional training described in
p.000999: paragraph (1)(C) or prior to the completion of such borrower’s participation in such training.
p.000999: (d) CANCELLATION OF LIABILITY.—The liability to repay the un- paid balance of such a loan and accrued
p.000999: interest thereon shall be canceled upon the death of the borrower, or if the Secretary deter- mines that he has
p.000999: become permanently, and totally disabled.
p.000999: (e) RATE OF INTEREST.—Such loans shall bear interest, on the unpaid balance of the loan, computed only for
p.000999: periods for which the loan is repayable, at the rate of 5 percent per year.
p.000999: (f) SECURITY OR ENDORSEMENT.—Loans shall be made under this subpart without security or endorsement,
p.000999: except that if the borrower is a minor and the note or other evidence of obligation ex- ecuted by him would not,
p.000999: under the applicable law, create a bind- ing obligation, either security or endorsement may be required.
p.000999: (g) TRANSFERRING AND ASSIGNING LOANS.—No note or other evidence of a loan made under this subpart may be
p.000999: transferred or assigned by the school making the loan except that, if the bor- rowers transfer to another
p.000999: school participating in the program under this subpart, such note or other evidence of a loan may be
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p.001005: (1) is carrying out a program for recruiting and retaining students from disadvantaged backgrounds, including
p.001005: racial and ethnic minorities; and
p.001005: (2) is carrying out a program for recruiting and retaining minority faculty.
p.001005: (c) CERTAIN AGREEMENTS REGARDING EDUCATION OF STU- DENTS; DATE CERTAIN FOR COMPLIANCE.—The
p.001005: Secretary may not make a Federal capital contribution for purposes of subsection (a) for a fiscal year
p.001005: unless the health professions school involved agrees—
p.001005: (1) to ensure that adequate instruction regarding minority health issues is provided for in the curricula of the
p.001005: school;
p.001005: (2) with respect to health clinics providing services to a significant number of individuals who are
p.001005: from disadvantaged backgrounds, including members of minority groups, to enter into arrangements with 1 or more
p.001005: such clinics for the purpose of providing students of the school with experience in providing clinical services to such
p.001005: individuals;
p.001005: (3) with respect to public or nonprofit private secondary educational institutions and undergraduate
p.001005: institutions of higher education, to enter into arrangements with 1 or more such institutions for the
p.001005: purpose of carrying out programs re- garding the educational preparation of disadvantaged students, including
p.001005: minority students, to enter the health professions and regarding the recruitment of such individuals into
p.001005: the health professions;
p.001005: (4) to establish a mentor program for assisting disadvan- taged students, including minority students,
p.001005: regarding the completion of the educational requirements for degrees from the school;
p.001005: (5) to be carrying out each of the activities specified in any of paragraphs (1) through (4) by not later than 1 year
p.001005: after the date on which the first Federal capital contribution is made to the school for purposes of subsection (a);
p.001005: and
p.001005: (6) to continue carrying out such activities, and the activi- ties specified in paragraphs (1) and (2) of
p.001005: subsection (b),
p.001005: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001005: Sec. 725 PUBLIC HEALTH SERVICE ACT 1006
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p.001005: throughout the period during which the student loan fund es- tablished pursuant to section 721(b) is in
p.001005: operation.
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p.001009: 1009
p.001009: PUBLIC HEALTH SERVICE ACT
p.001009: Sec. 736
p.001009:
p.001009: (f) FUNDING FOR CERTAIN MEDICAL SCHOOLS.—
p.001009: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making Federal capital contributions to student
p.001009: loan funds established under section 721 by schools of medicine or osteo- pathic medicine, there is
p.001009: authorized to be appropriated
p.001009: $10,000,000 for each of the fiscal years 1994 through 1996.
p.001009: (2) MINIMUM REQUIREMENTS.—
p.001009: (A) Subject to subparagraph (B), the Secretary may make a Federal capital contribution pursuant to paragraph
p.001009: (1) only if the school of medicine or osteopathic medicine involved meets the conditions described in
p.001009: subparagraph
p.001009: (A) of section 723(b)(2) or the conditions described in sub- paragraph (C) of such section.
p.001009: (B) For purposes of subparagraph (A), the conditions referred to in such subparagraph shall be applied with re-
p.001009: spect to graduates of the school involved whose date of graduation occurred approximately 3 years before June
p.001009: 30 of the fiscal year preceding the fiscal year for which the Federal capital contribution involved is made.
p.001009:
p.001009: PART B—HEALTH PROFESSIONS TRAINING FOR DIVERSITY
p.001009: SEC. 736. ø293¿ CENTERS OF EXCELLENCE.
p.001009: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, designated health
p.001009: professions schools de- scribed in subsection (c), and other public and nonprofit health or educational
p.001009: entities, for the purpose of assisting the schools in sup- porting programs of excellence in health professions
p.001009: education for under-represented minority individuals.
p.001009: (b) REQUIRED USE OF FUNDS.—The Secretary may not make a grant under subsection (a) unless the designated health
p.001009: professions school involved agrees, subject to subsection (c)(1)(C), to expend the grant—
p.001009:
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p.001009: (1) to develop a large competitive applicant pool through linkages with institutions of higher education, local
p.001009: school dis- tricts, and other community-based entities and establish an education pipeline for health
p.001009: professions careers;
p.001009: (2) to establish, strengthen, or expand programs to en- hance the academic performance of under-represented
p.001009: minority students attending the school;
p.001009: (3) to improve the capacity of such school to train, recruit, and retain under-represented minority faculty
p.001009: including the payment of such stipends and fellowships as the Secretary may determine appropriate;
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p.001009: (i) meet each of the conditions specified in para- graph (2)(A);
p.001009: (ii) meet each of the conditions specified in para- graph (3);
p.001009: (iii) meet each of the conditions specified in para- graph (4); or
p.001009: (iv) meet each of the conditions specified in para- graph (5).
p.001009: (B) GENERAL CONDITIONS.—The conditions specified in this subparagraph are that a designated health professions school—
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p.001009: (i) has a significant number of under-represented minority individuals enrolled in the school, including
p.001009: individuals accepted for enrollment in the school;
p.001009: (ii) has been effective in assisting under-rep- resented minority students of the school to complete
p.001009: the program of education and receive the degree in- volved;
p.001009: (iii) has been effective in recruiting under-rep- resented minority individuals to enroll in and grad-
p.001009: uate from the school, including providing scholarships and other financial assistance to such individuals and
p.001009: encouraging under-represented minority students from all levels of the educational pipeline to pursue health
p.001009: professions careers; and
p.001009: (iv) has made significant recruitment efforts to in- crease the number of under-represented minority indi- viduals
p.001009: serving in faculty or administrative positions at the school.
p.001009: (C) CONSORTIUM.—The condition specified in this sub- paragraph is that, in accordance with subsection (e)(1), the
p.001009: designated health profession school involved has with other health profession schools (designated or
p.001009: otherwise) formed a consortium to carry out the purposes described in subsection (b) at the schools of the consortium.
p.001009: (D) APPLICATION OF CRITERIA TO OTHER PROGRAMS.—In the case of any criteria established by the Secretary
p.001009: for purposes of determining whether schools meet the condi- tions described in subparagraph (B), this section
p.001009: may not,
p.001009: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: 1011
p.001011: PUBLIC HEALTH SERVICE ACT
p.001011: Sec. 736
p.001011:
p.001011: with respect to racial and ethnic minorities, be construed to authorize, require, or prohibit the use of such
p.001011: criteria in any program other than the program established in this section.
p.001011: (2) CENTERS OF EXCELLENCE AT CERTAIN HISTORICALLY BLACK COLLEGES AND UNIVERSITIES.—
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p.001011: applies to the designated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Hispanic individ- uals; and
p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit community based His- panic serving organizations, or public or nonprofit pri-
p.001011: vate institutions of higher education, including schools of nursing, whose enrollment of students has tradi-
p.001011: tionally included a significant number of Hispanic in- dividuals, the purposes of which will be to carry out a
p.001011: program—
p.001011: (I) to identify Hispanic students who are in- terested in a career in the health profession in- volved;
p.001011: and
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p.001011: January 30, 2020
p.001011: 7 So in law. Probably should read ‘‘paragraph (2) or (5)’’.
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001011: Sec. 736 PUBLIC HEALTH SERVICE ACT 1012
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p.001011: (II) to facilitate the educational preparation of such students to enter the health professions school; and
p.001011: (ii) the school will make efforts to recruit Hispanic students, including students who have participated in the
p.001011: undergraduate or other matriculation program carried out under arrangements established by the school
p.001011: pursuant to clause (i)(II) and will assist His- panic students regarding the completion of the edu-
p.001011: cational requirements for a degree from the school.
p.001011: (4) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Subject to subsection (e), the conditions specified in this
p.001011: paragraph are that—
p.001011: (A) with respect to Native Americans, each of clauses
p.001011: (i) through (iv) of paragraph (1)(B) applies to the des- ignated health professions school involved;
p.001011: (B) the school agrees, as a condition of receiving a grant under subsection (a), that the school will, in
p.001011: carrying out the duties described in subsection (b), give priority to carrying out the duties with
p.001011: respect to Native Americans; and
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p.001011: (C) the school agrees, as a condition of receiving a grant under subsection (a), that—
p.001011: (i) the school will establish an arrangement with
p.001011: 1 or more public or nonprofit private institutions of higher education, including schools of nursing,
p.001011: whose enrollment of students has traditionally included a significant number of Native Americans, the
p.001011: purpose of which arrangement will be to carry out a program—
p.001011: (I) to identify Native American students, from the institutions of higher education referred to in clause (i),
p.001011: who are interested in health professions careers; and
p.001011: (II) to facilitate the educational preparation of such students to enter the designated health pro- fessions
p.001011: school; and
p.001011: (ii) the designated health professions school will make efforts to recruit Native American students, in-
p.001011: cluding students who have participated in the under- graduate program carried out under arrangements es-
p.001011: tablished by the school pursuant to clause (i) and will assist Native American students regarding the comple- tion of
p.001011: the educational requirements for a degree from the designated health professions school.
p.001011: (5) OTHER CENTERS OF EXCELLENCE.—The conditions speci- fied in this paragraph are—
p.001011: (A) with respect to other centers of excellence, the con- ditions described in clauses (i) through (iv) of
p.001011: paragraph (1)(B); and
p.001011: (B) that the health professions school involved has an enrollment of under-represented minorities above the na-
p.001011: tional average for such enrollments of health professions schools.
p.001011: (d) DESIGNATION AS CENTER OF EXCELLENCE.—
p.001011: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001013: 1013
p.001013: PUBLIC HEALTH SERVICE ACT
p.001013: Sec. 736
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p.001013: (1) IN GENERAL.—Any designated health professions school receiving a grant under subsection (a) and meeting the
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p.001015: (1) $50,000,000 for each of the fiscal years 2010 through 2015; and
p.001015: (2) and such sums as are necessary for each subsequent fiscal year.
p.001015: SEC. 737. ø293a¿ SCHOLARSHIPS FOR DISADVANTAGED STUDENTS.
p.001015: (a) IN GENERAL.—The Secretary may make a grant to an eligi- ble entity (as defined in subsection (d)(1)) under this
p.001015: section for the awarding of scholarships by schools to any full-time student who is an eligible individual as
p.001015: defined in subsection (d). Such scholar-
p.001015: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001015: Sec. 738 PUBLIC HEALTH SERVICE ACT 1016
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p.001015: ships may be expended only for tuition expenses, other reasonable educational expenses, and reasonable living
p.001015: expenses incurred in the attendance of such school.
p.001015: (b) PREFERENCE IN PROVIDING SCHOLARSHIPS.—The Secretary may not make a grant to an entity under subsection (a)
p.001015: unless the health professions and nursing schools involved agree that, in pro- viding scholarships pursuant to the
p.001015: grant, the schools will give preference to students for whom the costs of attending the schools would constitute
p.001015: a severe financial hardship and, notwithstanding other provisions of this section, to former recipients of
p.001015: scholarships under sections 736 and 740(d)(2)(B) (as such sections existed on the day before the date of enactment of
p.001015: this section).
p.001015: (c) AMOUNT OF AWARD.—In awarding grants to eligible entities that are health professions and nursing schools, the
p.001015: Secretary shall give priority to eligible entities based on the proportion of grad- uating students going
p.001015: into primary care, the proportion of under- represented minority students, and the proportion of graduates
p.001015: working in medically underserved communities.
p.001015: (d) DEFINITIONS.—In this section:
p.001015: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means an entity that—
p.001015: (A) is a school of medicine, osteopathic medicine, den- tistry, nursing (as defined in section 801),
p.001015: pharmacy, podiatric medicine, optometry, veterinary medicine, public health, chiropractic, or allied health,
p.001015: a school offering a graduate program in behavioral and mental health prac- tice, or an entity providing
p.001015: programs for the training of physician assistants; and
p.001015: (B) is carrying out a program for recruiting and retain- ing students from disadvantaged backgrounds, including
p.001015: students who are members of racial and ethnic minority groups.
p.001015: (2) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who—
p.001015: (A) is from a disadvantaged background;
p.001015: (B) has a financial need for a scholarship; and
p.001015: (C) is enrolled (or accepted for enrollment) at an eligi- ble health professions or nursing school as a full-time stu-
p.001015: dent in a program leading to a degree in a health profes- sion or nursing.
p.001015: SEC. 738. ø293b¿ LOAN REPAYMENTS AND FELLOWSHIPS REGARDING FACULTY POSITIONS.
p.001015: (a) LOAN REPAYMENTS.—
p.001015: (1) ESTABLISHMENT OF PROGRAM.—The Secretary shall es- tablish a program of entering into contracts with
p.001015: individuals described in paragraph (2) under which the individuals agree to serve as members of the
p.001015: faculties of schools described in paragraph (3) in consideration of the Federal Government agreeing
p.001015: to pay, for each year of such service, not more than
p.001015: $30,000 of the principal and interest of the educational loans of such individuals.
p.001015: (2) ELIGIBLE INDIVIDUALS.—The individuals referred to in paragraph (1) are individuals from disadvantaged
p.001015: backgrounds who—
p.001015: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001017: 1017
p.001017: PUBLIC HEALTH SERVICE ACT
p.001017: Sec. 738
p.001017:
p.001017: (A) have a degree in medicine, osteopathic medicine, dentistry, nursing, or another health profession;
p.001017: (B) are enrolled in an approved graduate training pro- gram in medicine, osteopathic medicine, dentistry, nursing, or
p.001017: other health profession; or
p.001017: (C) are enrolled as full-time students—
p.001017: (i) in an accredited (as determined by the Sec- retary) school described in paragraph (3); and
p.001017: (ii) in the final year of a course of a study or pro- gram, offered by such institution and approved by the Secretary,
p.001017: leading to a degree from such a school.
p.001017: (3) ELIGIBLE HEALTH PROFESSIONS SCHOOLS.—The schools described in this paragraph are schools of medicine,
p.001017: nursing (as schools of nursing are defined in section 801), osteopathic medicine, dentistry, pharmacy,
p.001017: allied health, podiatric medi- cine, optometry, veterinary medicine, or public health, schools offering
p.001017: physician assistant education programs, or schools of- fering graduate programs in behavioral and mental health.
p.001017: (4) REQUIREMENTS REGARDING FACULTY POSITIONS.—The Secretary may not enter into a contract under
p.001017: paragraph (1) unless—
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p.001017: (A) the individual involved has entered into a contract with a school described in paragraph (3) to serve as
p.001017: a member of the faculty of the school for not less than 2 years; and
p.001017: (B) the contract referred to in subparagraph (A) pro- vides that—
p.001017: (i) the school will, for each year for which the indi- vidual will serve as a member of the faculty under the contract
p.001017: with the school, make payments of the prin- cipal and interest due on the educational loans of the
p.001017: individual for such year in an amount equal to the amount of such payments made by the Secretary for
p.001017: the year;
p.001017: (ii) the payments made by the school pursuant to clause (i) on behalf of the individual will be in addition to
p.001017: the pay that the individual would otherwise receive for serving as a member of such faculty; and
p.001017: (iii) the school, in making a determination of the amount of compensation to be provided by the school
p.001017: to the individual for serving as a member of the fac- ulty, will make the determination without regard
p.001017: to the amount of payments made (or to be made) to the individual by the Federal Government under para-
p.001017: graph (1).
p.001017: (5) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of sections 338C, 338G, and 338I shall apply to the
p.001017: program established in paragraph (1) to the same extent and in the same manner as such provisions apply to
p.001017: the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III,
p.001017: including the applicability of provi- sions regarding reimbursements for increased tax liability and regarding
p.001017: bankruptcy.
p.001017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001019: PUBLIC HEALTH SERVICE ACT
p.001019: Sec. 739
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p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
p.001019: (B) facilitating the entry of such individuals into such a school;
p.001019: (C) providing counseling, mentoring, or other services designed to assist such individuals to complete
p.001019: successfully their education at such a school;
p.001019: (D) providing, for a period prior to the entry of such individuals into the regular course of education
p.001019: of such a school, preliminary education and health research training designed to assist them to complete
p.001019: successfully such reg- ular course of education at such a school, or referring such individuals to institutions
p.001019: providing such preliminary edu- cation;
p.001019: (E) publicizing existing sources of financial aid avail- able to students in the education program of such a
p.001019: school or who are undertaking training necessary to qualify them to enroll in such a program;
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p.001019: student-enhancement programs (other than regular courses), except that such a stipend may not be
p.001019: provided to an individual for more than 12 months, and such a sti- pend shall be in an amount determined appropriate by
p.001019: the Secretary (notwithstanding any other provision of law re- garding the amount of stipends);
p.001019: (H) carrying out programs under which such individ- uals gain experience regarding a career in a field
p.001019: of pri- mary health care through working at facilities of public or private nonprofit community-based providers of
p.001019: primary health services; and
p.001019: (I) conducting activities to develop a larger and more competitive applicant pool through partnerships with
p.001019: insti- tutions of higher education, school districts, and other community-based entities.
p.001019: (3) DEFINITION.—In this section, the term ‘‘regular course of education of such a school’’ as used in
p.001019: subparagraph (D) in- cludes a graduate program in behavioral or mental health.
p.001019: (b) REQUIREMENTS FOR AWARDS.—In making awards to eligible entities under subsection (a)(1), the Secretary shall give
p.001019: preference to approved applications for programs that involve a comprehensive approach by several public or
p.001019: nonprofit private health or edu- cational entities to establish, enhance and expand educational pro- grams that
p.001019: will result in the development of a competitive appli- cant pool of individuals from disadvantaged
p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
p.001019: common objectives with institutions of higher education, school dis- tricts, and other community-based entities.
p.001019: (2) Such formal agreements shall reflect the coordination of educational activities and support services,
p.001019: increased link- ages, and the consolidation of resources within a specific geo- graphic area.
p.001019: (3) The design of the educational activities involved shall provide for the establishment of a
p.001019: competitive health profes- sions applicant pool of individuals from disadvantaged back- grounds by enhancing
p.001019: the total preparation (academic and so- cial) of such individuals to pursue a health professions career.
p.001019: (4) The programs or activities under the award shall focus on developing a culturally competent health care
p.001019: workforce that will serve the unserved and underserved populations within the geographic area.
p.001019: (c) EQUITABLE ALLOCATION OF FINANCIAL ASSISTANCE.—The Secretary, to the extent practicable, shall ensure that
p.001019: services and activities under subsection (a) are adequately allocated among the various racial and ethnic
p.001019: populations who are from disadvantaged backgrounds.
p.001019: (d) MATCHING REQUIREMENTS.—The Secretary may require that an entity that applies for a grant or contract
p.001019: under subsection (a), provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of
p.001019: the entity to the projects funded
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: PUBLIC HEALTH SERVICE ACT
p.001021: Sec. 741
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p.001021: January 30, 2020
p.001021: under the grant or contract. As determined by the Secretary, such non-Federal matching funds may be provided
p.001021: directly or through donations from public or private entities and may be in cash or in- kind, fairly evaluated,
p.001021: including plant, equipment, or services.
p.001021: SEC. 740. ø293d¿ AUTHORIZATION OF APPROPRIATION.
p.001021: (a) SCHOLARSHIPS.—There are authorized to be appropriated to carry out section 737, $51,000,000 for fiscal year
p.001021: 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2014. Of the amount appropriated in
p.001021: any fiscal year, the Secretary shall ensure that not less than 16 percent shall be distributed to schools of
p.001021: nursing.
p.001021: (b) LOAN REPAYMENTS AND FELLOWSHIPS.—For the purpose of carrying out section 738, there is authorized to
p.001021: be appropriated,
p.001021: $5,000,000 for each of the fiscal years 2010 through 2014.
p.001021: (c) EDUCATIONAL ASSISTANCE IN HEALTH PROFESSIONS REGARD- ING INDIVIDUALS FOR DISADVANTAGED BACKGROUNDS.—For
p.001021: the pur- pose of grants and contracts under section 739(a)(1), there is au- thorized to be appropriated
p.001021: $60,000,000 for fiscal year 2010 and such sums as may be necessary for each of the fiscal years 2011
p.001021: through 2014. The Secretary may use not to exceed 20 percent of the amount appropriated for a fiscal
p.001021: year under this subsection to provide scholarships under section 739(a)(2)(F).
p.001021: (d) REPORT.—Not later than 6 months after the date of enact- ment of this part, the Secretary shall
p.001021: prepare and submit to the appropriate committees of Congress a report concerning the efforts of the Secretary to
p.001021: address the need for a representative mix of in- dividuals from historically minority health professions schools,
p.001021: or from institutions or other entities that historically or by geographic location have a demonstrated record
p.001021: of training or educating underrepresented minorities, within various health professions dis- ciplines, on peer
p.001021: review councils.
p.001021: SEC. 741. ø293e¿ GRANTS FOR HEALTH PROFESSIONS EDUCATION.
p.001021: (a) CULTURAL COMPETENCY, PREVENTION, AND PUBLIC HEALTH AND INDIVIDUALS WITH DISABILITY GRANTS.—
p.001021: (1) IN GENERAL.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001021: Administra- tion, may make awards of grants, contracts, or cooperative agreements to public and nonprofit
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p.001025: SEC. 747A. ø293k–1¿ TRAINING OPPORTUNITIES FOR DIRECT CARE WORKERS.
p.001025: (a) IN GENERAL.—The Secretary shall award grants to eligible entities to enable such entities to provide new
p.001025: training opportuni- ties for direct care workers who are employed in long-term care set- tings such as nursing homes
p.001025: (as defined in section 1908(e)(1) of the Social Security Act (42 U.S.C. 1396g(e)(1)), assisted living facilities and
p.001025: skilled nursing facilities, intermediate care facilities for indi- viduals with mental retardation, home
p.001025: and community based set- tings, and any other setting the Secretary determines to be appro- priate.
p.001025: (b) ELIGIBILITY.—To be eligible to receive a grant under this section, an entity shall—
p.001025: (1) be an institution of higher education (as defined in sec- tion 102 of the Higher Education Act of 1965 (20 U.S.C.
p.001025: 1002)) that—
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p.001025: (A) is accredited by a nationally recognized accrediting agency or association listed under section 101(c) of
p.001025: the Higher Education Act of 1965 (20 U.S.C. 1001(c)); and
p.001025: (B) has established a public-private educational part- nership with a nursing home or skilled nursing
p.001025: facility, agency or entity providing home and community based services to individuals with disabilities, or
p.001025: other long-term care provider; and
p.001025: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001025: Sec- retary may require.
p.001025: (c) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant under this section
p.001025: to provide assistance to eligible individuals to offset the cost of tuition and required fees for enrollment in
p.001025: academic programs provided by such entity.
p.001025: (d) ELIGIBLE INDIVIDUAL.—
p.001025: (1) ELIGIBILITY.—To be eligible for assistance under this section, an individual shall be enrolled in
p.001025: courses provided by a grantee under this subsection and maintain satisfactory aca- demic progress in such courses.
p.001025: (2) CONDITION OF ASSISTANCE.—As a condition of receiving assistance under this section, an individual shall
p.001025: agree that, following completion of the assistance period, the individual will work in the field of geriatrics,
p.001025: disability services, long term
p.001025: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001025: Sec. 748 PUBLIC HEALTH SERVICE ACT 1026
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p.001027: (1) Qualified applicants that propose collaborative projects between departments of primary care medicine and
p.001027: depart- ments of general, pediatric, or public health dentistry.
p.001027: (2) Qualified applicants that have a record of training the greatest percentage of providers, or that
p.001027: have demonstrated significant improvements in the percentage of providers, who enter and remain in general,
p.001027: pediatric, or public health den- tistry.
p.001027: (3) Qualified applicants that have a record of training indi- viduals who are from a rural or disadvantaged background,
p.001027: or from underrepresented minorities.
p.001027: (4) Qualified applicants that establish formal relationships with Federally qualified health centers, rural health
p.001027: centers, or accredited teaching facilities and that conduct training of stu- dents, residents, fellows, or
p.001027: faculty at the center or facility.
p.001027: (5) Qualified applicants that conduct teaching programs targeting vulnerable populations such as older
p.001027: adults, home- less individuals, victims of abuse or trauma, individuals with mental health or
p.001027: substance-related disorders, individuals with disabilities, and individuals with HIV/AIDS, and in the risk-
p.001027: based clinical disease management of all populations.
p.001027: (6) Qualified applicants that include educational activities in cultural competency and health literacy.
p.001027: (7) Qualified applicants that have a high rate for placing graduates in practice settings that serve
p.001027: underserved areas or health disparity populations, or who achieve a significant in- crease in the rate of
p.001027: placing graduates in such settings.
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001027: Sec. 749 PUBLIC HEALTH SERVICE ACT 1028
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p.001027: (8) Qualified applicants that intend to establish a special populations oral health care education center
p.001027: or training pro- gram for the didactic and clinical education of dentists, dental health professionals, and dental
p.001027: hygienists who plan to teach oral health care for people with developmental disabilities, cog- nitive impairment,
p.001027: complex medical problems, significant phys- ical limitations, and vulnerable elderly.
p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
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p.001033: (a) COLLABORATION.—To be eligible to receive assistance under this part, an academic institution shall use such
p.001033: assistance in col- laboration with 2 or more disciplines.
p.001033: (b) ACTIVITIES.—An entity shall use assistance under this part to carry out innovative demonstration projects for
p.001033: strategic work- force supplementation activities as needed to meet national goals for interdisciplinary,
p.001033: community-based linkages. Such assistance may be used consistent with this part—
p.001033: (1) to develop and support training programs;
p.001033: (2) for faculty development;
p.001033: (3) for model demonstration programs;
p.001033: (4) for the provision of stipends for fellowship trainees;
p.001033: (5) to provide technical assistance; and
p.001033: (6) for other activities that will produce outcomes con- sistent with the purposes of this part.
p.001033: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001033: Sec. 751 PUBLIC HEALTH SERVICE ACT 1034
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p.001033: SEC. 751. ø294a¿ AREA HEALTH EDUCATION CENTERS.
p.001033: (a) ESTABLISHMENT OF AWARDS.—The Secretary shall make the following 2 types of awards in accordance with this section:
p.001033: (1) INFRASTRUCTURE DEVELOPMENT AWARD.—The Secretary shall make awards to eligible entities to enable such
p.001033: entities to initiate health care workforce educational programs or to continue to carry out comparable
p.001033: programs that are operating at the time the award is made by planning, developing, oper- ating, and
p.001033: evaluating an area health education center pro- gram.
p.001033: (2) POINT OF SERVICE MAINTENANCE AND ENHANCEMENT AWARD.—The Secretary shall make awards to eligible
p.001033: entities to maintain and improve the effectiveness and capabilities of an existing area health education
p.001033: center program, and make other modifications to the program that are appropriate due to changes in demographics,
p.001033: needs of the populations served, or other similar issues affecting the area health education center program. For
p.001033: the purposes of this section, the term ‘‘Program’’ refers to the area health education center program.
p.001033: (b) ELIGIBLE ENTITIES; APPLICATION.—
p.001033: (1) ELIGIBLE ENTITIES.—
p.001033: (A) INFRASTRUCTURE DEVELOPMENT.—For purposes of subsection (a)(1), the term ‘‘eligible entity’’ means a school of
p.001033: medicine or osteopathic medicine, an incorporated con- sortium of such schools, or the parent institutions
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p.001037: (2) REQUIREMENTS.—Of the amounts appropriated for a fis- cal year under paragraph (1)—
p.001037: (A) not more than 35 percent shall be used for awards under subsection (a)(1);
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p.001037: Sec. 752 PUBLIC HEALTH SERVICE ACT 1038
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p.001037: (B) not less than 60 percent shall be used for awards under subsection (a)(2);
p.001037: (C) not more than 1 percent shall be used for grants and contracts to implement outcomes evaluation for
p.001037: the area health education centers; and
p.001037: (D) not more than 4 percent shall be used for grants and contracts to provide technical assistance to
p.001037: entities re- ceiving awards under this section.
p.001037: (3) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from 1
p.001037: fiscal year to another without obtaining approval from the Secretary. In no case may any funds be carried
p.001037: over pursuant to the preceding sentence for more than 3 years.
p.001037: (k) SENSE OF CONGRESS.—It is the sense of the Congress that every State have an area health education center
p.001037: program in effect under this section.
p.001037: SEC. 752. ø294b¿ CONTINUING EDUCATIONAL SUPPORT FOR HEALTH PROFESSIONALS SERVING IN UNDERSERVED COMMU-
p.001037: NITIES.
p.001037: (a) IN GENERAL.—The Secretary shall make grants to, and enter into contracts with, eligible entities to
p.001037: improve health care, increase retention, increase representation of minority faculty members, enhance
p.001037: the practice environment, and provide informa- tion dissemination and educational support to reduce
p.001037: professional isolation through the timely dissemination of research findings using relevant resources.
p.001037: (b) ELIGIBLE ENTITIES.—For purposes of this section, the term ‘‘eligible entity’’ means an entity described in section
p.001037: 799(b).
p.001037: (c) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001037: Secretary an applica- tion at such time, in such manner, and containing such information as the Secretary may require.
p.001037: (d) USE OF FUNDS.—An eligible entity shall use amounts awarded under a grant or contract under this
p.001037: section to provide in- novative supportive activities to enhance education through dis- tance learning,
p.001037: continuing educational activities, collaborative con- ferences, and electronic and telelearning activities, with
p.001037: priority for primary care.
p.001037: (e) AUTHORIZATION.—There is authorized to be appropriated to carry out this section $5,000,000 for each of the
p.001037: fiscal years 2010 through 2014, and such sums as may be necessary for each subse- quent fiscal year.
p.001037: SEC. 753. ø294c¿ EDUCATION AND TRAINING RELATING TO GERI- ATRICS.
p.001037: (a) GERIATRIC EDUCATION CENTERS.—
p.001037: (1) IN GENERAL.—The Secretary shall award grants or con- tracts under this section to entities described in
p.001037: paragraphs 11 (1), (3), or (4) of section 799B, and section 801(2), for the estab- lishment or operation of geriatric
p.001037: education centers.
p.001037: (2) REQUIREMENTS.—A geriatric education center is a pro- gram that—
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p.001037: 11 So in law. Probably should read ‘‘paragraph’’.
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p.001039: PUBLIC HEALTH SERVICE ACT
p.001039: Sec. 753
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p.001055: (b) NATIONAL CENTER FOR HEALTH CARE WORKFORCE ANAL-
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p.001055: (1) ESTABLISHMENT.—The Secretary shall establish the Na- tional Center for Health Workforce Analysis (referred to in
p.001055: this section as the ‘‘National Center’’).
p.001055: (2) PURPOSES.—The National Center, in coordination to the extent practicable with the National Health Care
p.001055: Workforce Commission (established in section 5101 of the Patient Protec- tion and Affordable Care Act), and relevant
p.001055: regional and State centers and agencies, shall—
p.001055: (A) provide for the development of information describ- ing and analyzing the health care workforce and workforce
p.001055: related issues;
p.001055: (B) carry out the activities under section 792(a);
p.001055: (C) annually evaluate programs under this title;
p.001055: (D) develop and publish performance measures and benchmarks for programs under this title; and
p.001055: (E) establish, maintain, and publicize a national Inter- net registry of each grant awarded under this title
p.001055: and a database to collect data from longitudinal evaluations (as described in subsection (d)(2)) on
p.001055: performance measures (as developed under sections 749(d)(3), 757(d)(3), and 762(a)(3)).
p.001055: (3) COLLABORATION AND DATA SHARING.—
p.001055: (A) IN GENERAL.—The National Center shall collabo- rate with Federal agencies and relevant professional
p.001055: and educational organizations or societies for the purpose of linking data regarding grants awarded under this
p.001055: title.
p.001055: (B) CONTRACTS FOR HEALTH WORKFORCE ANALYSIS.— For the purpose of carrying out the activities described
p.001055: in
p.001055: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001055: subparagraph (A), the National Center may enter into con- tracts with relevant professional and educational organiza-
p.001055: tions or societies.
p.001055: (c) STATE AND REGIONAL CENTERS FOR HEALTH WORKFORCE ANALYSIS.—
p.001055: (1) IN GENERAL.—The Secretary shall award grants to, or enter into contracts with, eligible entities for
p.001055: purposes of—
p.001055: (A) collecting, analyzing, and reporting data regarding programs under this title to the National Center and
p.001055: to the public; and
p.001055: (B) providing technical assistance to local and regional entities on the collection, analysis, and reporting of
p.001055: data.
p.001055: (2) ELIGIBLE ENTITIES.—To be eligible for a grant or con- tract under this subsection, an entity shall—
p.001055: (A) be a State, a State workforce investment board, a public health or health professions school, an
p.001055: academic health center, or an appropriate public or private nonprofit entity; and
p.001055: (B) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.001055: Secretary may require.
p.001055: (d) INCREASE IN GRANTS FOR LONGITUDINAL EVALUATIONS.—
p.001055: (1) IN GENERAL.—The Secretary shall increase the amount awarded to an eligible entity under this title for a
p.001055: longitudinal evaluation of individuals who have received education, train- ing, or financial assistance from
p.001055: programs under this title.
p.001055: (2) CAPABILITY.—A longitudinal evaluation shall be capa- ble of—
p.001055: (A) studying practice patterns; and
p.001055: (B) collecting and reporting data on performance measures developed under sections 749(d)(3),
p.001055: 757(d)(3), and 762(a)(3).
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p.001061: (e) TRAINEESHIPS.—
p.001061: (1) IN GENERAL.—With respect to amounts used under this section for the training of health professionals, such
p.001061: training programs shall be designed to—
p.001061: (A) make public health education more accessible to the public and private health workforce;
p.001061: (B) increase the relevance of public health academic preparation to public health practice in the future;
p.001061: (C) provide education or training for students from traditional on-campus programs in practice-based sites;
p.001061: or
p.001061: (D) develop educational methods and distance-based approaches or technology that address adult learning re-
p.001061: quirements and increase knowledge and skills related to community-based cultural diversity in public health
p.001061: edu- cation.
p.001061: (2) SEVERE SHORTAGE DISCIPLINES.—Amounts provided under grants or contracts under this section may be
p.001061: used for the operation of programs designed to award traineeships to students in accredited schools of
p.001061: public health who enter edu- cational programs in fields where there is a severe shortage of public health
p.001061: professionals, including epidemiology, biostatis- tics, environmental health, toxicology, public health
p.001061: nursing, nutrition, preventive medicine, maternal and child health, and behavioral and mental health professions.
p.001061: SEC. 766. ø295a¿ PUBLIC HEALTH TRAINING CENTERS.
p.001061: (a) IN GENERAL.—The Secretary may make grants or contracts for the operation of public health training centers.
p.001061: (b) ELIGIBLE ENTITIES.—
p.001061: (1) IN GENERAL.—A public health training center shall be an accredited school of public health, or another
p.001061: public or non- profit private institution accredited for the provision of grad- uate or specialized training in
p.001061: public health, that plans, devel- ops, operates, and evaluates projects that are in furtherance of the goals
p.001061: established by the Secretary for the year 2000 in the areas of preventive medicine, health promotion and disease
p.001061: prevention, or improving access to and quality of health serv- ices in medically underserved communities.
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p.001061: (A) academic administrative units (including depart- ments, divisions, or other appropriate units) in
p.001061: preventive medicine and public health; or
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p.001063: January 30, 2020
p.001063: (B) programs that improve clinical teaching in preven- tive medicine and public health.
p.001063: (d) REPORT.—The Secretary shall submit to the Congress an annual report on the program carried out under this
p.001063: section.
p.001063: SEC. 769. ø295d¿ HEALTH ADMINISTRATION TRAINEESHIPS AND SPE- CIAL PROJECTS.
p.001063: (a) IN GENERAL.—The Secretary may make grants to State or local governments (that have in effect preventive
p.001063: medical and den- tal public health residency programs) or public or nonprofit private educational entities (including
p.001063: graduate schools of social work and business schools that have health management programs) that offer a program
p.001063: described in subsection (b)—
p.001063: (1) to provide traineeships for students enrolled in such a program; and
p.001063: (2) to assist accredited programs health administration in the development or improvement of programs to
p.001063: prepare stu- dents for employment with public or nonprofit private entities.
p.001063: (b) RELEVANT PROGRAMS.—The program referred to in sub- section (a) is an accredited program in health
p.001063: administration, hos- pital administration, or health policy analysis and planning, which program is accredited by a
p.001063: body or bodies approved for such pur- pose by the Secretary of Education and which meets such other
p.001063: quality standards as the Secretary of Health and Human Services by regulation may prescribe.
p.001063: (c) PREFERENCE IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall give preference to
p.001063: qualified ap- plicants that meet the following conditions:
p.001063: (1) Not less than 25 percent of the graduates of the appli- cant are engaged in full-time practice settings in
p.001063: medically un- derserved communities.
p.001063: (2) The applicant recruits and admits students from medi- cally underserved communities.
p.001063: (3) For the purpose of training students, the applicant has established relationships with public and nonprofit
p.001063: providers of health care in the community involved.
p.001063: (4) In training students, the applicant emphasizes employ- ment with public or nonprofit private entities.
p.001063: (d) CERTAIN PROVISIONS REGARDING TRAINEESHIPS.—
...

p.001065: setting;
p.001065: (2) have familiarity with evidence-based methods and cul- tural and linguistic competence health care services;
p.001065: and
p.001065: (3) demonstrate financial need.
p.001065: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated $30,000,000 for each of
p.001065: fiscal years 2010 through 2014 to carry out subsection (c)(1)(A) and $20,000,000 for each of fiscal
p.001065: years 2010 through 2013 to carry out subsection (c)(1)(B).
p.001065: SEC. 776. ø295f–1¿ PUBLIC HEALTH WORKFORCE LOAN REPAYMENT PROGRAM.
p.001065: (a) ESTABLISHMENT.—The Secretary shall establish the Public Health Workforce Loan Repayment Program
p.001065: (referred to in this section as the ‘‘Program’’) to assure an adequate supply of public health
p.001065: professionals to eliminate critical public health workforce shortages in Federal, State, local, and tribal public
p.001065: health agencies.
p.001065: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001065:
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p.001065:
p.001065:
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p.001065:
p.001065: Sec. 776 PUBLIC HEALTH SERVICE ACT 1066
p.001065:
p.001065: (b) ELIGIBILITY.—To be eligible to participate in the Program, an individual shall—
p.001065: (1)(A) be accepted for enrollment, or be enrolled, as a stu- dent in an accredited academic educational
p.001065: institution in a State or territory in the final year of a course of study or pro- gram leading to a public health or
p.001065: health professions degree or certificate; and have accepted employment with a Federal, State, local, or tribal
p.001065: public health agency, or a related training fellowship, as recognized by the Secretary, to commence upon
p.001065: graduation; 16
p.001065: (B)(i) have graduated, during the preceding 10-year period, from an accredited educational institution in a
p.001065: State or terri- tory and received a public health or health professions degree or certificate; and
p.001065: (ii) be employed by, or have accepted employment with, a Federal, State, local, or tribal public health agency
p.001065: or a related training fellowship, as recognized by the Secretary;
p.001065: (2) be a United States citizen; and
p.001065: (3)(A) submit an application to the Secretary to participate in the Program;
p.001065: (B) execute a written contract as required in subsection (c);
p.001065: and
p.001065: (4) not have received, for the same service, a reduction of
p.001065: loan obligations under section 455(m), 428J, 428K, 428L, or 460 of the Higher Education Act of 1965.
p.001065: (c) CONTRACT.—The written contract (referred to in this section as the ‘‘written contract’’) between the Secretary and
p.001065: an individual shall contain—
p.001065: (1) an agreement on the part of the Secretary that the Sec- retary will repay on behalf of the individual loans
p.001065: incurred by the individual in the pursuit of the relevant degree or certifi- cate in accordance with the
p.001065: terms of the contract;
p.001065: (2) an agreement on the part of the individual that the in- dividual will serve in the full-time employment of
p.001065: a Federal, State, local, or tribal public health agency or a related fellow- ship program in a position
p.001065: related to the course of study or program for which the contract was awarded for a period of time
p.001065: (referred to in this section as the ‘‘period of obligated serv- ice’’) equal to the greater of—
p.001065: (A) 3 years; or
p.001065: (B) such longer period of time as determined appro- priate by the Secretary and the individual;
...

p.001067: under paragraph (2) on behalf of an individual, the Secretary shall, in addition to such payments, make
p.001067: payments to the individual in an amount not to exceed 39 percent of the total amount of loan repayments
p.001067: made for the taxable year involved.
p.001067: (e) POSTPONING OBLIGATED SERVICE.—With respect to an indi- vidual receiving a degree or certificate from a health
p.001067: professions or other related school, the date of the initiation of the period of obli- gated service may be postponed
p.001067: as approved by the Secretary.
p.001067: (f) BREACH OF CONTRACT.—An individual who fails to comply with the contract entered into under subsection (c)
p.001067: shall be subject to the same financial penalties as provided for under section 338E for breaches of loan repayment
p.001067: contracts under section 338B.
p.001067: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.001067: $195,000,000 for fiscal year 2010, and such sums as may be necessary for each of fiscal years 2011
p.001067: through 2015.
p.001067: SEC. 777. ø295f–2¿ TRAINING FOR MID-CAREER PUBLIC AND ALLIED HEALTH PROFESSIONALS.
p.001067: (a) IN GENERAL.—The Secretary may make grants to, or enter into contracts with, any eligible entity to award
p.001067: scholarships to eli- gible individuals to enroll in degree or professional training pro- grams for the
p.001067: purpose of enabling mid-career professionals in the public health and allied health workforce to receive
p.001067: additional training in the field of public health and allied health.
p.001067: (b) ELIGIBILITY.—
p.001067: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ indicates an accredited educational institution that
p.001067: offers a course of study, certificate program, or professional training program in
p.001067: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001067:
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p.001067:
p.001067: Sec. 778 PUBLIC HEALTH SERVICE ACT 1068
p.001067:
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p.001067: January 30, 2020
p.001067:
p.001067: public or allied health or a related discipline, as determined by the Secretary
p.001067: (2) ELIGIBLE INDIVIDUALS.—The term ‘‘eligible individuals’’ includes those individuals employed in public and allied
p.001067: health positions at the Federal, State, tribal, or local level who are in- terested in retaining or upgrading their
p.001067: education.
p.001067: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
...

p.001079: ‘‘behavioral health and mental health practice,’’ before ‘‘clinical’’. The amendment cannot be executed
p.001079: because the amendment does not specify to which instance of the term ‘‘clinical’’ the amendment applies.
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001079:
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p.001079:
p.001079: Sec. 799B PUBLIC HEALTH SERVICE ACT 1080
p.001079:
p.001079: (2) The term ‘‘teaching facilities’’ means areas dedicated for use by students, faculty, or administrative
p.001079: or maintenance personnel for clinical purposes, research activities, libraries, classrooms, offices,
p.001079: auditoriums, dining areas, student activi- ties, or other related purposes necessary for, and appropriate
p.001079: to, the conduct of comprehensive programs of education. Such term includes interim facilities but does not
p.001079: include off-site im- provements or living quarters.
p.001079: (3) PHYSICIAN ASSISTANT EDUCATION PROGRAM.—The term ‘‘physician assistant education program’’ means an educational
p.001079: program in a public or private institution in a State that—
p.001079: (A) has as its objective the education of individuals who, upon completion of their studies in the
p.001079: program, be qualified to provide primary care medical services with the supervision of a physician; and
p.001079: (B) is accredited by the Accreditation Review Commis- sion on Education for the Physician Assistant.
p.001079: (4) The term ‘‘school of allied health’’ means a public or nonprofit private college, junior college, or
p.001079: university or hos- pital-based educational entity that—
p.001079: (A) provides, or can provide, programs of education to enable individuals to become allied health professionals or to
p.001079: provide additional training for allied health profes- sionals;
p.001079: (B) provides training for not less than a total of twenty persons in the allied health curricula (except that this sub-
p.001079: paragraph shall not apply to any hospital-based edu- cational entity);
p.001079: (C) includes or is affiliated with a teaching hospital;
p.001079: and
p.001079: (D) is accredited by a recognized body or bodies ap-
p.001079: proved for such purposes by the Secretary of Education, or which provides to the Secretary satisfactory assurance
p.001079: by such accrediting body or bodies that reasonable progress is being made toward accreditation.
p.001079: (5) The term ‘‘allied health professionals’’ means a health professional (other than a registered nurse or
p.001079: physician assist- ant)—
p.001079:
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p.001079: (A) who has received a certificate, an associate’s de- gree, a bachelor’s degree, a master’s degree, a doctoral
p.001079: de- gree, or postbaccalaureate training, in a science relating to health care;
p.001079: (B) who shares in the responsibility for the delivery of health care services or related services, including—
p.001079: (i) services relating to the identification, evalua- tion, and prevention of disease and disorders;
p.001079: (ii) dietary and nutrition services;
...

p.001081: 4(a)(3) of Public Law 104-299.
p.001081: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001081:
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p.001081:
p.001081: Sec. 799B PUBLIC HEALTH SERVICE ACT 1082
p.001081:
p.001081: (B) is licensed or certified on the basis of the doctoral degree in psychology, by the State in which the individual
p.001081: practices, at the independent practice level of psychology to furnish diagnostic, assessment, preventive,
p.001081: and thera- peutic services directly to individuals.
p.001081: (12) AREA HEALTH EDUCATION CENTER.—The term ‘‘area health education center’’ means a public or
p.001081: nonprofit private organization that has a cooperative agreement or contract in effect with an entity that
p.001081: has received an award under sub- section (a)(1) or (a)(2) of section 751, satisfies the requirements in section
p.001081: 751(d)(1), and has as one of its principal functions the operation of an area health education center.
p.001081: Appropriate organizations may include hospitals, health organizations with accredited primary care training
p.001081: programs, accredited physi- cian assistant educational programs associated with a college or university,
p.001081: and universities or colleges not operating a school of medicine or osteopathic medicine.
p.001081: (13) AREA HEALTH EDUCATION CENTER PROGRAM.—The term ‘‘area health education center program’’ means
p.001081: coopera- tive program consisting of an entity that has received an award under subsection (a)(1) or
p.001081: (a)(2) of section 751 for the purpose of planning, developing, operating, and evaluating an area health
p.001081: education center program and one or more area health education centers, which carries out the required activi-
p.001081: ties described in section 751(c), satisfies the program require- ments in such section, has as one of
p.001081: its principal functions identifying and implementing strategies and activities that ad- dress health care workforce
p.001081: needs in its service area, in coordi- nation with the local workforce investment boards.
p.001081: (14) CLINICAL SOCIAL WORKER.—The term ‘‘clinical social worker’’ has the meaning given the term in section
p.001081: 1861(hh)(1) of the Social Security Act (42 U.S.C. 1395x(hh)(1)).
...

p.001089: (a) IN GENERAL.—The Secretary may award grants to and enter into contracts with eligible entities to meet the
p.001089: costs of—
p.001089: (1) projects that support the enhancement of advanced nursing education and practice; and
p.001089: (2) traineeships for individuals in advanced nursing edu- cation programs.
p.001089: (b) DEFINITION OF ADVANCED EDUCATION NURSES.—For pur- poses of this section, the term ‘‘advanced education
p.001089: nurses’’ means individuals trained in advanced degree programs including individ- uals in combined R.N./Master’s degree
p.001089: programs, post-nursing mas- ter’s certificate programs, or, in the case of nurse midwives, in cer- tificate programs
p.001089: in existence on the date that is one day prior to the date of enactment of this section, to serve as
p.001089: nurse practi- tioners, clinical nurse specialists, nurse midwives, nurse anes- thetists, nurse
p.001089: educators, nurse administrators, or public health nurses, or in other nurse specialties determined by the
p.001089: Secretary to require advanced education.
p.001089: (c) AUTHORIZED NURSE PRACTITIONER.—Nurse practitioner pro- grams eligible for support under this section are
p.001089: educational pro- grams for registered nurses (irrespective of the type of school of nursing in which the
p.001089: nurses received their training) that—
p.001089: (1) meet guidelines prescribed by the Secretary; and
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001089:
p.001089:
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p.001089:
p.001089: Sec. 821 PUBLIC HEALTH SERVICE ACT 1090
p.001089:
p.001089: (2) have as their objective the education of nurses who will upon completion of their studies in such programs, be
p.001089: qualified to effectively provide primary health care, including primary health care in homes and in
p.001089: ambulatory care facilities, long- term care facilities, acute care, and other health care settings.
p.001089: (d) AUTHORIZED NURSE-MIDWIFERY PROGRAMS.—Midwifery pro- grams that are eligible for support under this
p.001089: section are edu- cational programs that—
p.001089: (1) have as their objective the education of midwives; and
p.001089: (2) are accredited by the American College of Nurse-Mid- wives Accreditation Commission for Midwifery
p.001089: Education.
p.001089: (e) AUTHORIZED NURSE ANESTHESIA PROGRAMS.—Nurse anes- thesia programs eligible for support under this
p.001089: section are edu- cation programs that—
p.001089: (1) provide registered nurses with full-time anesthetist education; and
p.001089: (2) are accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs.
p.001089: (f) OTHER AUTHORIZED EDUCATIONAL PROGRAMS.—The Sec- retary shall prescribe guidelines as appropriate for
p.001089: other advanced nurse education programs eligible for support under this section.
p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
...

p.001099: compromise, waive, or release any right, title, claim, or demand of the United States aris- ing or acquired under this
p.001099: part.
p.001099:
p.001099:
p.001099:
p.001099: January 30, 2020
p.001099: 7 So in law. Probably should read ‘‘part’’.
p.001099:
p.001099: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001099:
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p.001101: 1101
p.001101: PUBLIC HEALTH SERVICE ACT
p.001101: Sec. 846
p.001101:
p.001101: PROCEDURES FOR APPEAL OF TERMINATIONS
p.001101: SEC. 842. 8 ø297i¿ In any case in which the Secretary intends to terminate an agreement with a school
p.001101: of nursing under this part, the Secretary shall provide the school with a written notice specifying such
p.001101: intention and stating that the school may request a formal hearing with respect to such termination. If the
p.001101: school re- quests such a hearing within 30 days after the receipt of such no- tice, the Secretary shall provide
p.001101: such school with a hearing con- ducted by an administrative law judge.
p.001101: LOAN REPAYMENT AND SCHOLARSHIP PROGRAMS
p.001101: SEC. 846. 9 ø297n¿ (a) IN GENERAL.—In the case of any indi- vidual—
p.001101: (1) who has received a baccalaureate or associate degree in nursing (or an equivalent degree), a diploma in
p.001101: nursing, or a graduate degree in nursing;
p.001101: (2) who obtained (A) one or more loans from a loan fund established under subpart II 10, or (B) any
p.001101: other educational loan for nurse training costs; and
p.001101: (3) who enters into an agreement with the Secretary to serve as nurse for a period of not less than
p.001101: two years at a health care facility with a critical shortage of nurses, or in a accredited school of
p.001101: nursing, as defined by section 801(2), as nurse faculty;
p.001101: the Secretary shall make payments in accordance with subsection (b), for and on behalf of that individual, on
p.001101: the principal of and in- terest on any loan of that individual described in paragraph (2) of this subsection
p.001101: which is outstanding on the date the individual be- gins the service specified in the agreement described in paragraph
p.001101: (3) of this subsection. After fiscal year 2007, the Secretary may not, pursuant to any agreement entered into under
p.001101: this subsection, as- sign a nurse to any private entity unless that entity is nonprofit.
p.001101: (b) MANNER OF PAYMENTS.—The payments described in sub- section (a) shall be made by the Secretary as follows:
p.001101: (1) Upon completion by the individual for whom the pay- ments are to be made of the first year of
p.001101: the service specified in the agreement entered into with the Secretary under sub- section (a), the Secretary
p.001101: shall pay 30 percent of the principal of, and the interest on each loan of such individual described in
p.001101: subsection (a)(2) which is outstanding on the date he began such practice.
p.001101: (2) Upon completion by that individual of the second year of such service, the Secretary shall pay
p.001101: another 30 percent of the principal of, and the interest on each such loan.
p.001101: (3) Upon completion by that individual of a third year of such service, the Secretary shall pay another 25
...

p.001103: agreements involved is impossible, or would involve ex- treme hardship to the individual or facility, and if
p.001103: enforcement of the agreements with respect to the individual or facility would be unconscionable.
p.001103: (3) DATE CERTAIN FOR RECOVERY.—Subject to paragraph (2), any amount that the Federal Government is entitled
p.001103: to re- cover under paragraph (1) shall be paid to the United States not later than the expiration of the
p.001103: 3-year period beginning on the date the United States becomes so entitled.
p.001103: (4) AVAILABILITY.—Amounts recovered under paragraph (1) with respect to a program under this section shall be available
p.001103: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001103:
p.001103:
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p.001103:
p.001103: Sec. 846A PUBLIC HEALTH SERVICE ACT 1104
p.001103:
p.001103: for the purposes of such program, and shall remain available for such purposes until expended.
p.001103: (h) REPORTS.—Not later than 18 months after the date of en- actment of the Nurse Reinvestment Act, and
p.001103: annually thereafter, the Secretary shall prepare and submit to the Congress a report describing the
p.001103: programs carried out under this section, including statements regarding—
p.001103: (1) the number of enrollees, scholarships, loan repayments, and grant recipients;
p.001103: (2) the number of graduates;
p.001103: (3) the amount of scholarship payments and loan repay- ments made;
p.001103: (4) which educational institution the recipients attended;
p.001103: (5) the number and placement location of the scholarship and loan repayment recipients at health care
p.001103: facilities with a critical shortage of nurses;
p.001103: (6) the default rate and actions required;
p.001103: (7) the amount of outstanding default funds of both the scholarship and loan repayment programs;
p.001103: (8) to the extent that it can be determined, the reason for the default;
p.001103: (9) the demographics of the individuals participating in the scholarship and loan repayment programs;
p.001103: (10) justification for the allocation of funds between the scholarship and loan repayment programs; and
p.001103: (11) an evaluation of the overall costs and benefits of the programs.
p.001103: (i) FUNDING.—
p.001103: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of payments under agreements entered into under
p.001103: subsection
p.001103: (a) or (d), there are authorized to be appropriated such sums as may be necessary for each of fiscal years
p.001103: 2003 through 2007.
p.001103: (2) ALLOCATIONS.—Of the amounts appropriated under paragraph (1), the Secretary may, as determined
p.001103: appropriate by the Secretary, allocate amounts between the program under subsection (a) and the program under
p.001103: subsection (d).
p.001103:
p.001103:
p.001103:
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p.001103: NURSE FACULTY LOAN PROGRAM
p.001103: SEC. 846A. ø297n–1¿ (a) SCHOOL OF NURSING STUDENT LOAN
p.001103: FUND.—The Secretary, acting through the Administrator of the Health Resources and Services Administration,
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p.001145: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001147: 1147
p.001147: PUBLIC HEALTH SERVICE ACT
p.001147: Sec. 936
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p.001147: January 30, 2020
p.001147: SEC. 936. ø299b–36¿ PROGRAM TO FACILITATE SHARED DECISION- MAKING.
p.001147: (a) PURPOSE.—The purpose of this section is to facilitate col- laborative processes between patients,
p.001147: caregivers or authorized rep- resentatives, and clinicians that engages the patient, caregiver or authorized
p.001147: representative in decisionmaking, provides patients, caregivers or authorized representatives with
p.001147: information about trade-offs among treatment options, and facilitates the incorpora- tion of patient
p.001147: preferences and values into the medical plan.
p.001147: (b) DEFINITIONS.—In this section:
p.001147: (1) PATIENT DECISION AID.—The term ‘‘patient decision aid’’ means an educational tool that helps patients,
p.001147: caregivers or authorized representatives understand and communicate their beliefs and preferences related to
p.001147: their treatment options, and to decide with their health care provider what treatments are best for them
p.001147: based on their treatment options, scientific evi- dence, circumstances, beliefs, and preferences.
p.001147: (2) PREFERENCE SENSITIVE CARE.—The term ‘‘preference sensitive care’’ means medical care for which the
p.001147: clinical evi- dence does not clearly support one treatment option such that the appropriate course of treatment
p.001147: depends on the values of the patient or the preferences of the patient, caregivers or au- thorized representatives
p.001147: regarding the benefits, harms and sci- entific evidence for each treatment option, the use of such care should depend
p.001147: on the informed patient choice among clinically appropriate treatment options.
p.001147: (c) ESTABLISHMENT OF INDEPENDENT STANDARDS FOR PATIENT DECISION AIDS FOR PREFERENCE SENSITIVE CARE.—
p.001147: (1) CONTRACT WITH ENTITY TO ESTABLISH STANDARDS AND CERTIFY PATIENT DECISION AIDS.—
p.001147: (A) IN GENERAL.—For purposes of supporting con- sensus-based standards for patient decision aids for
p.001147: pref- erence sensitive care and a certification process for patient decision aids for use in the Federal health
p.001147: programs and by other interested parties, the Secretary shall have in ef- fect a contract with the entity with
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p.001147:
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p.001147: January 30, 2020
p.001147: (A) to develop, update, and produce patient decision aids for preference sensitive care to assist health care
p.001147: pro- viders in educating patients, caregivers, and authorized representatives concerning the relative safety,
p.001147: relative ef- fectiveness (including possible health outcomes and impact on functional status), and relative cost
p.001147: of treatment or, where appropriate, palliative care options;
p.001147: (B) to test such materials to ensure such materials are balanced and evidence based in aiding health care pro-
p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and
p.001147: (C) to educate providers on the use of such materials, including through academic curricula.
p.001147: (2) REQUIREMENTS FOR PATIENT DECISION AIDS.—Patient decision aids developed and produced pursuant to a
p.001147: grant or contract under paragraph (1)—
p.001147: (A) shall be designed to engage patients, caregivers, and authorized representatives in informed
p.001147: decision- making with health care providers;
p.001147: (B) shall present up-to-date clinical evidence about the risks and benefits of treatment options in a form and man- ner
p.001147: that is age-appropriate and can be adapted for pa- tients, caregivers, and authorized representatives
p.001147: from a variety of cultural and educational backgrounds to reflect the varying needs of consumers and
p.001147: diverse levels of health literacy;
p.001147: (C) shall, where appropriate, explain why there is a lack of evidence to support one treatment option
p.001147: over an- other; and
p.001147: (D) shall address health care decisions across the age span, including those affecting vulnerable
p.001147: populations in- cluding children.
p.001147: (3) DISTRIBUTION.—The Director shall ensure that patient decision aids produced with grants or contracts under
p.001147: this sec- tion are available to the public.
p.001147: (4) NONDUPLICATION OF EFFORTS.—The Director shall en- sure that the activities under this section of
p.001147: the Agency and other agencies, including the Centers for Disease Control and
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001149: PUBLIC HEALTH SERVICE ACT
p.001149: Sec. 937
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p.001159: 1976; $5,000,000 for the fiscal year ending Sep- tember 30, 1977; $3,000,000 for the fiscal year ending
p.001159: September 30, 1978; $3,100,000 for the fiscal year ending September 30, 1979;
p.001159: $3,600,000 for the fiscal year ending September 30, 1980;
p.001159: $4,100,000 for the fiscal year ending September 30, 1981;
p.001159: $2,920,000 for the fiscal year ending September 30, 1982;
p.001159: $3,200,000 for the fiscal year ending September 30, 1983;
p.001159: $3,500,000 for the fiscal year ending September 30, 1984; and
p.001159: $3,500,000 for the fiscal year ending September 30, 1985.
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p.001159: January 30, 2020
p.001159:
p.001159: RESEARCH
p.001159: SEC. 1004. ø300a–2¿ The Secretary may—
p.001159: (1) conduct, and
p.001159: (2) make grants to public or nonprofit private entities and enter into contracts with public or private entities and
p.001159: individ- uals for projects for,
p.001159: research in the biomedical, contraceptive development, behavioral, and program implementation fields related to
p.001159: family planning and population.
p.001159: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001161: 1161
p.001161: PUBLIC HEALTH SERVICE ACT
p.001161: Sec. 1006
p.001161:
p.001161: INFORMATIONAL AND EDUCATIONAL MATERIALS
p.001161: SEC. 1005. ø300a–3¿ (a) The Secretary is authorized to make grants to public or nonprofit private entities and
p.001161: to enter into con- tracts with public or private entities and individuals to assist in de- veloping and making
p.001161: available family planning and population growth information (including educational materials) to all persons
p.001161: desiring such information (or materials).
p.001161: (b) For the purpose of making payments pursuant to grants and contracts under this section, there are
p.001161: authorized to be appro- priated $750,000 for the fiscal year ending June 30, 1971;
p.001161: $1,000,000 for the fiscal year ending June 30, 1972; $1,250,000 for the fiscal year ending June 30, 1973;
p.001161: $909,000 each for the fiscal years ending June 30, 1974, and June 30, 1975; $2,000,000 for fis- cal year 1976;
p.001161: $2,500,000 for the fiscal year ending September 30, 1977; $600,000 for the fiscal year ending September
p.001161: 30, 1978;
p.001161: $700,000 for the fiscal year ending September 30, 1979; $805,000 for the fiscal year ending September 30,
p.001161: 1980; $926,000 for the fis- cal year ending September 30, 1981; $570,000 for the fiscal year ending
p.001161: September 30, 1982; $600,000 for the fiscal year ending September 30, 1983; $670,000 for the fiscal year ending
p.001161: September 30, 1984; and $700,000 for the fiscal year ending September 30, 1985.
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p.001161: January 30, 2020
p.001161:
p.001161: REGULATIONS AND PAYMENTS
p.001161:
p.001161: SEC. 1006. ø300a–4¿ (a) Grants and contracts made under this title shall be made in accordance with such regulations as
p.001161: the Sec- retary may promulgate. The amount of any grant under any sec- tion of this title shall be
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p.001161: (1) priority will be given in such project or program to the furnishing of such services to persons from
p.001161: low-income fami- lies; and
p.001161: (2) no charge will be made in such project or program for services provided to any person from a
p.001161: low-income family ex- cept to the extent that payment will be made by a third party
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001161: Sec. 1007 PUBLIC HEALTH SERVICE ACT 1162
p.001161:
p.001161: (including a government agency) which is authorized or is under legal obligation to pay such charge.
p.001161: For purposes of this subsection, the term ‘‘low-income family’’ shall be defined by the Secretary in accordance with
p.001161: such criteria as he may prescribe so as to insure that economic status shall not be a deterrent to
p.001161: participation in the programs assisted under this title. (d)(1) A grant may be made or a contract entered
p.001161: into under section 1001 or 1005 only upon assurances satisfactory to the Sec- retary that informational or
p.001161: educational materials developed or made available under the grant or contract will be suitable for the purposes of
p.001161: this title and for the population or community to which they are to be made available, taking into account the
p.001161: educational and cultural background of the individuals to whom such materials are addressed and the standards of such
p.001161: population or community
p.001161: with respect to such materials.
p.001161: (2) In the case of any grant or contract under section 1001, such assurances shall provide for the
p.001161: review and approval of the suitability of such materials, prior to their distribution, by an advi- sory committee
p.001161: established by the grantee or contractor in accord- ance with the Secretary’s regulations. Such a
p.001161: committee shall in- clude individuals broadly representative of the population or com- munity to which the
p.001161: materials are to be made available.
p.001161: VOLUNTARY PARTICIPATION
p.001161: SEC. 1007. ø300a–5¿ The acceptance by any individual of fam- ily planning services or family planning or population
p.001161: growth infor- mation (including educational materials) provided through finan- cial assistance under this title
p.001161: (whether by grant or contract) shall be voluntary and shall not be a prerequisite to eligibility for or re- ceipt of
p.001161: any other service or assistance from, or to participation in, any other program of the entity or individual
p.001161: that provided such service or information.
p.001161: PROHIBITION OF ABORTION
p.001161: SEC. 1008. 2 ø300a–6¿ None of the funds appropriated under this title shall be used in programs where abortion
p.001161: is a method of family planning.
p.001161: TITLE XI—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME
p.001161: PART A—GENETIC DISEASES
p.001161: RESEARCH PROJECT GRANTS AND CONTRACTS
p.001161: SEC. 1102. ø300b–1¿ In carrying out section 301, the Secretary, may make grants to public and nonprofit private
p.001161: entities, and may enter into contracts with public and private entities and individ- uals, for projects for
p.001161: (1) basic or applied research leading to the un- derstanding, diagnosis, treatment, and control of genetic
p.001161: diseases,
p.001161: (2) planning, establishing, demonstrating, and developing special programs for the training of genetic
p.001161: counselors, social and behav-
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p.001161: January 30, 2020
p.001161: 2 Section 1009 was repealed by section 601(a)(1)(G) of Public Law 105–362 (112 Stat. 3285).
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001165: (iii) the maternal and child health program under title V of the Social Security Act (42 U.S.C. 701 et seq.)
p.001165: for the State in which the entity is located.
p.001165: (B) To train nursing and other health staff who pro- vide care for individuals with sickle cell disease.
p.001165: (C) To enter into a partnership with adult or pediatric hematologists in the region and other regional experts
p.001165: in sickle cell disease at tertiary and academic health centers and State and county health offices.
p.001165: (D) To identify and secure resources for ensuring reim- bursement under the medicaid program, State children’s
p.001165: health insurance program, and other health programs for the prevention and treatment of sickle cell disease.
p.001165: (E) To provide or coordinate services for adolescents with sickle cell disease making the transition to
p.001165: adult health care.
p.001165: (3) NATIONAL COORDINATING CENTER.—
p.001165: (A) ESTABLISHMENT.—The Administrator shall enter into a contract with an entity to serve as the National Co-
p.001165: ordinating Center for the demonstration program con- ducted under this subsection.
p.001165: (B) ACTIVITIES DESCRIBED.—The National Coordi- nating Center shall—
p.001165: (i) collect, coordinate, monitor, and distribute data, best practices, and findings regarding the activi-
p.001165: ties funded under grants made to eligible entities under the demonstration program;
p.001165: (ii) develop a model protocol for eligible entities with respect to the prevention and treatment of sickle cell
p.001165: disease;
p.001165: (iii) develop educational materials regarding the prevention and treatment of sickle cell disease; and
p.001165: (iv) prepare and submit to Congress a final report that includes recommendations regarding the effec- tiveness
p.001165: of the demonstration program conducted under this subsection and such direct outcome meas- ures as—
p.001165: (I) the number and type of health care re- sources utilized (such as emergency room visits, hospital
p.001165: visits, length of stay, and physician visits for individuals with sickle cell disease); and
p.001165: (II) the number of individuals that were test- ed and subsequently received genetic counseling for the
p.001165: sickle cell trait.
p.001165: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001167: 1167
p.001167: PUBLIC HEALTH SERVICE ACT
p.001167: Sec. 1107
p.001167:
p.001167: (4) APPLICATION.—An eligible entity desiring a grant under this subsection shall submit an application to the
p.001167: Adminis- trator at such time, in such manner, and containing such infor- mation as the Administrator may require.
p.001167: (5) DEFINITIONS.—In this subsection:
p.001167: (A) ADMINISTRATOR.—The term ‘‘Administrator’’ means the Administrator of the Health Resources and Services
p.001167: Administration.
p.001167: (B) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a Federally-qualified health center, a nonprofit hos-
p.001167: pital or clinic, or a university health center that provides primary health care, that—
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p.001167: Sec. 1108 PUBLIC HEALTH SERVICE ACT 1168
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p.001167: January 30, 2020
p.001167:
p.001167: TOURETTE SYNDROME
p.001167: SEC. 1108. ø300b–7¿ (a) IN GENERAL.—The Secretary shall de- velop and implement outreach programs to educate the
p.001167: public, health care providers, educators and community based organiza- tions about the etiology, symptoms,
p.001167: diagnosis and treatment of Tourette Syndrome, with a particular emphasis on children with Tourette Syndrome.
p.001167: Such programs may be carried out by the Sec- retary directly and through awards of grants or contracts to public or
p.001167: nonprofit private entities.
p.001167: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) shall include—
p.001167: (1) the production and translation of educational materials, including public service announcements;
p.001167: (2) the development of training material for health care providers, educators and community based
p.001167: organizations; and
p.001167: (3) outreach efforts directed at the misdiagnosis and underdiagnosis of Tourette Syndrome in children and
p.001167: in minor- ity groups.
p.001167: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001167: to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.001167: SEC. 1109. ø300b–8¿ IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: 1169
p.001169: PUBLIC HEALTH SERVICE ACT
p.001169: Sec. 1109
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p.001169: (A) the collection, delivery, receipt, and screening of specimens; and
p.001169: (B) the diagnosis of heritable disorders in newborns.
p.001169: (b) ELIGIBLE ENTITY.—In this section, the term ‘‘eligible entity’’ means—
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p.001173: Advisory Committee Act, an advisory committee established by the President or an offi- cer of the Federal
p.001173: Government under section 9(a) of such Act.
p.001173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001173: Sec. 1112 PUBLIC HEALTH SERVICE ACT 1174
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p.001173: January 30, 2020
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p.001173: SEC. 1112. ø300b–11¿ CLEARINGHOUSE OF NEWBORN SCREENING IN- FORMATION.
p.001173: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001173: Administration (re- ferred to in this part as the ‘‘Administrator’’), in consultation with the Director of the Centers
p.001173: for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish and
p.001173: maintain a central clearinghouse of current educational and family support and services information,
p.001173: materials, resources, re- search, and data on newborn screening to—
p.001173: (1) enable parents and family members of newborns, health professionals, industry representatives, and
p.001173: other mem- bers of the public to increase their awareness, knowledge, and understanding of newborn screening;
p.001173: (2) increase awareness, knowledge, and understanding of newborn diseases and screening services for expectant
p.001173: individ- uals and families;
p.001173: (3) maintain current information on quality indicators to measure performance of newborn screening, such as
p.001173: false-posi- tive rates and other quality indicators as determined by the Advisory Committee under section
p.001173: 1111;
p.001173: (4) maintain current information on the number of condi- tions for which screening is conducted in each State;
p.001173: and
p.001173: (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect
p.001173: to condi- tions detected by newborn screening.
p.001173: (b) INTERNET AVAILABILITY.—The Secretary, acting through the Administrator, shall ensure that the clearinghouse
p.001173: described under subsection (a)—
p.001173: (1) is available on the Internet;
p.001173: (2) includes an interactive forum;
p.001173: (3) is updated on a regular basis, but not less than quar- terly; and
p.001173: (4) provides—
p.001173: (A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have
p.001173: dem- onstrated expertise in newborn screening that supply re- search-based information on newborn screening
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p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
p.001211: and the Secretary of De- fense a report for such year that includes information on—
p.001211: (A) the number and types of trauma cases managed by military trauma teams or military trauma care providers
p.001211: pursuant to such grant during such year;
p.001211: (B) the ability to maintain the integration of the mili- tary trauma providers or teams of providers as part of the
p.001211: trauma center, including the financial effect of such grant on the trauma center;
p.001211: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001213: PUBLIC HEALTH SERVICE ACT
p.001213: Sec. 1291
p.001213:
p.001213: (C) the educational effect on resident trainees in cen- ters where military trauma teams are assigned;
p.001213: (D) any research conducted during such year sup- ported by such grant; and
p.001213: (E) any other information required by the Secretaries for the purpose of evaluating the effect of such grant.
p.001213: (2) REPORT TO CONGRESS.—Not less than once every 2 years, the Secretary, in consultation with the Secretary of
p.001213: De- fense, shall submit a report to the congressional committees of jurisdiction that includes information on the
p.001213: effect of placing military trauma care providers in trauma centers awarded grants under this section on—
p.001213: (A) maintaining military trauma care providers’ readi- ness and ability to respond to and treat battlefield injuries;
p.001213: (B) providing health care to civilian trauma patients in urban and rural settings;
p.001213: (C) the capability of trauma centers and military trau- ma care providers to increase medical surge capacity,
p.001213: in- cluding as a result of a large-scale event;
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p.001223: January 30, 2020
p.001223: APPLICATION REQUIREMENTS
p.001223: SEC. 1306. ø300e–5¿ (a) No loan or loan guarantee may be made under this title unless an application therefor
p.001223: has been sub- mitted to and approved by the Secretary.
p.001223: (b) The Secretary may not approve an application for a loan or loan guarantee under this title unless—
p.001223: (1) such application meets the requirements of section 1308;
p.001223: (2) in the case of an application for assistance under sec- tion 1305, he determines that the applicant
p.001223: making the appli- cation would not be able to complete the project or undertaking for which the application is
p.001223: submitted without the assistance applied for;
p.001223: (3) the application contains satisfactory specification of the existing or anticipated (A) population group or
p.001223: groups to be served by the proposed or existing health maintenance organi- zation described in the application, (B)
p.001223: membership of such or- ganization, (C) methods, terms, and periods of the enrollment of members of such
p.001223: organization, (D) estimated costs per mem- ber of the health and educational services to be provided by such
p.001223: organization and the nature of such costs, (E) sources of professional services for such organization,
p.001223: and organizational arrangements of such organization for providing health and educational services, (F)
p.001223: organizational arrangements of such organization for an ongoing quality assurance program in con- formity with the
p.001223: requirements of section 1301(c), (G) sources of prepayment and other forms of payment for the services to be provided
p.001223: by such organization, (H) facilities, and additional capital investments and sources of financing therefor,
p.001223: available to such organization to provide the level and scope of services proposed, (I) administrative,
p.001223: managerial, and financial ar- rangements and capabilities of such organization, (J) role for members in
p.001223: the planning and policymaking for such organiza- tion, (K) grievance procedures for members of such organiza-
p.001223: tion, and (L) evaluations of the support for and acceptance of such organization by the population to
p.001223: be served, the sources of operating support, and the professional groups to be in- volved or affected
p.001223: thereby;
p.001223: (4) contains or is supported by assurances satisfactory to the Secretary that the applicant making the
p.001223: application will, in accordance with such criteria as the Secretary shall by regu- lation prescribe, enroll, and
p.001223: maintain an enrollment of the maximum number of members that its available and potential resources (as determined
p.001223: under regulations of the Secretary) will enable it to effectively serve;
p.001223: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001225: 1225
p.001225: PUBLIC HEALTH SERVICE ACT
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p.001265: (6) any other activity related to the reduction of excess hospital capacity.
p.001265: (b) Grants under subsection (a) shall be made on such terms and conditions as the Secretary may prescribe.
p.001265: AUTHORIZATION OF APPROPRIATIONS
p.001265: SEC. 1644. ø300t–14¿ To make payments under grants under sections 1642 and 1643 there are authorized to
p.001265: be appropriated
p.001265: $30,000,000 for the fiscal year ending September 30, 1980,
p.001265: $50,000,000 for the fiscal year ending September 30, 1981, and
p.001265: $75,000,000 for the fiscal year ending September 30, 1982, except that in any fiscal year not more than 10
p.001265: percent of the amount ap- propriated under this section may be obligated for grants under section 1643.
p.001265: TITLE XVII—HEALTH INFORMATION AND HEALTH PROMOTION
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p.001265: January 30, 2020
p.001265: GENERAL AUTHORITY
p.001265: SEC. 1701. ø300u¿ (a) The Secretary shall—
p.001265: (1) formulate national goals, and a strategy to achieve such goals, with respect to health information and
p.001265: health pro- motion, preventive health services, and education in the appro- priate use of health care;
p.001265: (2) analyze the necessary and available resources for im- plementing the goals and strategy
p.001265: formulated pursuant to paragraph (1), and recommend appropriate educational and quality assurance policies
p.001265: for the needed manpower resources identified by such analysis;
p.001265: (3) undertake and support necessary activities and pro- grams to—
p.001265: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001267: 1267
p.001267: PUBLIC HEALTH SERVICE ACT
p.001267: Sec. 1701
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p.001267: January 30, 2020
p.001267: (A) incorporate appropriate health education compo- nents into our society, especially into all aspects of
p.001267: edu- cation and health care,
p.001267: (B) increase the application and use of health knowl- edge, skills, and practices by the general population in
p.001267: its patterns of daily living, and
p.001267: (C) establish systematic processes for the exploration, development, demonstration, and evaluation of
p.001267: innovative health promotion concepts;
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p.001267: under this title without regard to sections 3648 and 3709 of the Revised Stat- utes (31 U.S.C. 529; 41 U.S.C. 5).
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p.001267: January 30, 2020
p.001267:
p.001267: RESEARCH PROGRAMS
p.001267: SEC. 1702. ø300u–1¿ (a) The Secretary is authorized to conduct and support by grant or contract (and encourage others
p.001267: to support) research in health information and health promotion, preventive health services, and education
p.001267: in the appropriate use of health care. Applications for grants and contracts under this section shall be subject
p.001267: to appropriate peer review. The Secretary shall also—
p.001267: (1) provide consultation and technical assistance to per- sons who need help in preparing research proposals or
p.001267: in actu- ally conducting research;
p.001267: (2) determine the best methods of disseminating informa- tion concerning personal health behavior,
p.001267: preventive health services and the appropriate use of health care and of affecting behavior so that such
p.001267: information is applied to maintain and improve health, and prevent disease, reduce its risk, or modify its course
p.001267: or severity;
p.001267: (3) determine and study environmental, occupational, so- cial, and behavioral factors which affect and
p.001267: determine health and ascertain those programs and areas for which educational
p.001267: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001269: 1269
p.001269: PUBLIC HEALTH SERVICE ACT
p.001269: Sec. 1703
p.001269:
p.001269: and preventive measures could be implemented to improve health as it is affected by such factors;
p.001269: (4) develop (A) methods by which the cost and effectiveness of activities respecting health information and
p.001269: health pro- motion, preventive health services, and education in the appro- priate use of health care, can be
p.001269: measured, including methods for evaluating the effectiveness of various settings for such ac- tivities and the various
p.001269: types of persons engaged in such activi- ties, (B) methods for reimbursement or payment for such ac- tivities,
p.001269: and (C) models and standards for the conduct of such activities, including models and standards for the
p.001269: education, by providers of institutional health services, of individuals receiv- ing such services respecting the
p.001269: nature of the institutional health services provided the individuals and the symptoms, signs, or diagnoses
p.001269: which led to provision of such services;
p.001269: (5) develop a method for assessing the cost and effective- ness of specific medical services and procedures
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p.001269: (1) support demonstration and training programs in such matters which programs (A) are in hospitals,
p.001269: ambulatory care settings, home care settings, schools, day care programs for children, and other
p.001269: appropriate settings representative of broad cross sections of the population, and include public edu- cation
p.001269: activities of voluntary health agencies, professional med- ical societies, and other private nonprofit health
p.001269: organizations,
p.001269: (B) focus on objectives that are measurable, and (C) emphasize
p.001269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001269: Sec. 1704 PUBLIC HEALTH SERVICE ACT 1270
p.001269:
p.001269: the prevention or moderation of illness or accidents that ap- pear controllable through individual
p.001269: knowledge and behavior;
p.001269: (2) provide consultation and technical assistance to organi- zations that request help in planning, operating, or
p.001269: evaluating programs in such matters;
p.001269: (3) develop health information and health promotion mate- rials and teaching programs including (A) model
p.001269: curriculums for the training of educational and health professionals and paraprofessionals in health
p.001269: education by medical, dental, and nursing schools, schools of public health, and other institutions engaged in
p.001269: training of educational or health professionals, (B) model curriculums to be used in elementary and
p.001269: secondary schools and institutions of higher learning, (C) materials and programs for the continuing
p.001269: education of health professionals and paraprofessionals in the health education of their patients,
p.001269: (D) materials for public service use by the printed and broad- cast media, and (E) materials and programs to
p.001269: assist providers of health care in providing health education to their patients; and
p.001269: (4) support demonstration and evaluation programs for in-
p.001269: dividual and group self-help programs designed to assist the participant in using his individual
p.001269: capacities to deal with health problems, including programs concerned with obesity, hypertension, and
p.001269: diabetes.
p.001269: (b) The Secretary is authorized to make grants to States and other public and nonprofit entities to
p.001269: assist them in meeting the costs of demonstrating and evaluating programs which provide in- formation
p.001269: respecting the costs and quality of health care or infor- mation respecting health insurance policies and
p.001269: prepaid health plans, or information respecting both. After the development of models pursuant to sections
p.001269: 1704(4) and 1704(5) for such informa- tion, no grant may be made under this subsection for a program unless
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p.001275: January 30, 2020
p.001275:
p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
p.001275: the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other
p.001275: appro- priate departmental entities regarding recommendations for carrying out activities under subsection (b)(9).
p.001275: (B) HEALTH PROFESSIONS EDUCATION REGARDING HEALTH DISPARITIES.—The Deputy Assistant Secretary
p.001275: shall carry out the duties under subsection (b)(10) in col- laboration with appropriate personnel of the
p.001275: Department of Health and Human Services, other Federal agencies, and other offices, centers, and institutions,
p.001275: as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and
p.001275: Education Act of 2000.
p.001275: (2) EQUITABLE ALLOCATION REGARDING ACTIVITIES.—In car- rying out subsection (b), the Secretary shall ensure
p.001275: that serv- ices provided under such subsection are equitably allocated among all groups served under this
p.001275: section by the Secretary.
p.001275: (3) CULTURAL COMPETENCY OF SERVICES.—The Secretary shall ensure that information and services provided
p.001275: pursuant to subsection (b) are provided in the language, educational, and cultural context that is most appropriate for
p.001275: the individuals for whom the information and services are intended.
p.001275: (e) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.001275: (1) IN GENERAL.—In carrying out subsection (b), the Sec- retary acting through the Deputy Assistant
p.001275: Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities.
p.001275: (2) PROCESS FOR MAKING AWARDS.—The Deputy Assistant Secretary shall ensure that awards under paragraph (1)
p.001275: are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the
p.001275: proposal has been recommended for such an award through a process of peer review.
p.001275: (3) EVALUATION AND DISSEMINATION.—The Deputy Assist- ant Secretary, directly or through contracts with
p.001275: public and private entities, shall provide for evaluations of projects carried out with awards made under
p.001275: paragraph (1) during the pre- ceding 2 fiscal years. The report shall be included in the report required under
p.001275: subsection (f) for the fiscal year involved.
p.001275: (f) REPORTS.—
p.001275: (1) IN GENERAL.—Not later than February 1 of fiscal year 1999 and of each second year thereafter, the
p.001275: Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the
p.001275: Committee on Labor and Human Resources of the Senate, a report describing the activi- ties carried out under this
p.001275: section during the preceding 2 fiscal years and evaluating the extent to which such activities have been
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p.001287: (E) The establishment, operation, and coordination of effec- tive and cost-efficient systems to reduce the
p.001287: prevalence of ill- ness due to asthma and asthma-related illnesses, especially among children, by reducing the
p.001287: level of exposure to cockroach allergen or other known asthma triggers through the use of in- tegrated pest
p.001287: management, as applied to cockroaches or other known allergens. Amounts expended for such systems may in- clude
p.001287: the costs of building maintenance and the costs of pro- grams to promote community participation in the
p.001287: carrying out at such sites of integrated pest management, as applied to
p.001287: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001287:
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p.001287: Sec. 1905 PUBLIC HEALTH SERVICE ACT 1288
p.001287:
p.001287: cockroaches or other known allergens. For purposes of this sub- paragraph, the term ‘‘integrated pest management’’
p.001287: means an approach to the management of pests in public facilities that combines biological, cultural,
p.001287: physical, and chemical tools in a way that minimizes economic, health, and environmental risks.
p.001287: (F) With respect to activities described in any of subpara- graphs (A) through (E), related planning,
p.001287: administration, and educational activities.
p.001287: (G) Monitoring and evaluation of activities carried out under any of subparagraphs (A) through (F).
p.001287: (2) Except as provided in subsection (b), amounts paid to a State under section 1903 from its allotment
p.001287: under section 1902(b) may only be used for providing services to rape victims and for rape prevention.
p.001287: (3) The Secretary may provide technical assistance to States in planning and operating activities to be carried out
p.001287: under this part.
p.001287: (b) A State may not use amounts paid to it under section 1903
p.001287:
p.001287: to—
p.001287: (1) provide inpatient services,
p.001287: (2) make cash payments to intended recipients of health services,
p.001287: (3) purchase or improve land, purchase, construct, or per- manently improve (other than minor remodeling) any
p.001287: building or other facility, or purchase major medical equipment,
p.001287: (4) satisfy any requirement for the expenditure of non-Fed- eral funds as a condition for the receipt of
p.001287: Federal funds, or
p.001287: (5) provide financial assistance to any entity other than a public or nonprofit private entity.
p.001287: Except as provided in subsection (a)(1)(E), the Secretary may waive the limitation contained in paragraph (3)
p.001287: upon the request of a State if the Secretary finds that there are extraordinary cir- cumstances
p.001287: to justify the waiver and that granting the waiver will assist in carrying out this part.
p.001287: (c) A State may transfer not more than 7 percent of the amount allotted to the State under section
p.001287: 1902(a) for any fiscal year for use by the State under part B of this title and title V of the
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p.001295:
p.001295: for fiscal year 2013, $30,387,656 for fiscal year 2014, $20,213,000 for each of fiscal years 2015
p.001295: through 2019, and $22,334,000 for each of fiscal years 2020 through 2024.
p.001295: PART B—BLOCK GRANTS REGARDING MENTAL HEALTH AND
p.001295: SUBSTANCE ABUSE
p.001295:
p.001295: Subpart I—Block Grants for Community Mental Health Services
p.001295: SEC. 1911. ø300x¿ FORMULA GRANTS TO STATES.
p.001295: (a) IN GENERAL.—For the purpose described in subsection (b), the Secretary, acting through the Director of the
p.001295: Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined
p.001295: in accordance with section 1918. The Secretary shall make a grant to the State of the allotment made
p.001295: for the State for the fiscal year if the State submits to the Secretary an application in accordance with
p.001295: section 1917.
p.001295: (b) PURPOSE OF GRANTS.—A funding agreement for a grant under subsection (a) is that, subject to section
p.001295: 1916, the State in- volved will expend the grant only for the purpose of—
p.001295: (1) providing community mental health services for adults with a serious mental illness and children with a serious
p.001295: emo- tional disturbance as defined in accordance with section 1912(c);
p.001295: (2) carrying out the plan submitted under section 1912(a) by the State for the fiscal year involved;
p.001295: (3) evaluating programs and services carried out under the plan; and
p.001295: (4) planning, administration, and educational activities re- lated to providing services under the plan.
p.001295: SEC. 1912. ø300x–1¿ STATE PLAN FOR COMPREHENSIVE COMMUNITY MENTAL HEALTH SERVICES FOR CERTAIN INDIVIDUALS.
p.001295: (a) IN GENERAL.—The Secretary may make a grant under sec- tion 1911 only if—
p.001295: (1) the State involved submits to the Secretary a plan for providing comprehensive community mental
p.001295: health services to adults with a serious mental illness and to children with a se- rious emotional disturbance;
p.001295: (2) the plan meets the criteria specified in subsection (b);
p.001295: and
p.001295: (3) the plan is approved by the Secretary.
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p.001295: January 30, 2020
p.001295: (b) CRITERIA FOR PLAN.—In accordance with subsection (a), a State shall submit to the Secretary a plan every
p.001295: two years that, at a minimum, includes each of the following:
p.001295: (1) SYSTEM OF CARE.—A description of the State’s system of care that contains the following:
p.001295: (A) COMPREHENSIVE COMMUNITY-BASED HEALTH SYS- TEMS.—The plan shall—
p.001295: (i) identify the single State agency to be respon- sible for the administration of the program under
p.001295: the grant, including any third party who administers men- tal health services and is responsible for complying
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001297: 1297
p.001297: PUBLIC HEALTH SERVICE ACT
p.001297: Sec. 1912
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p.001297: January 30, 2020
p.001297: with the requirements of this part with respect to the grant;
p.001297: (ii) provide for an organized community-based sys- tem of care for individuals with mental illness, and de- scribe
p.001297: available services and resources in a com- prehensive system of care, including services for indi-
p.001297: viduals with co-occurring disorders;
p.001297: (iii) include a description of the manner in which the State and local entities will coordinate services
p.001297: to maximize the efficiency, effectiveness, quality, and cost-effectiveness of services and programs to
p.001297: produce the best possible outcomes (including health services, rehabilitation services, employment services,
p.001297: housing services, educational services, substance use disorder services, legal services, law enforcement
p.001297: services, so- cial services, child welfare services, medical and dental care services, and other support services
p.001297: to be pro- vided with Federal, State, and local public and private resources) with other agencies to enable
p.001297: individuals receiving services to function outside of inpatient or residential institutions, to the
p.001297: maximum extent of their capabilities, including services to be provided by local school systems under the
p.001297: Individuals with Dis- abilities Education Act;
p.001297: (iv) include a description of how the State pro-
p.001297: motes evidence-based practices, including those evi- dence-based programs that address the needs of indi-
p.001297: viduals with early serious mental illness regardless of the age of the individual at onset, provide comprehen- sive
p.001297: individualized treatment, or integrate mental and physical health services;
p.001297: (v) include a description of case management serv- ices;
p.001297: (vi) include a description of activities that seek to engage adults with a serious mental illness or children with a
p.001297: serious emotional disturbance and their care- givers where appropriate in making health care deci- sions,
...

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p.001297:
p.001297: tings or arrangements to provide primary and spe- cialty care services in community-based mental and substance use
p.001297: disorders settings; and
p.001297: (IV) a description of recovery and recovery support services for adults with a serious mental illness and
p.001297: children with a serious emotional dis- turbance.
p.001297: (B) MENTAL HEALTH SYSTEM DATA AND EPIDEMI- OLOGY.—The plan shall contain an estimate of the
p.001297: inci- dence and prevalence in the State of serious mental illness among adults and serious emotional disturbance
p.001297: among children and present quantitative targets and outcome measures for programs and services
p.001297: provided under this subpart.
p.001297: (C) CHILDREN’S SERVICES.—In the case of children with a serious emotional disturbance (as defined pursuant
p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
...

p.001317: will improve the process in the State for re- ferring the individuals to treatment facilities that can provide
p.001317: to the individuals the treatment modality that is most appropriate for the individuals.
p.001317: (b) PROFESSIONAL DEVELOPMENT.—A funding agreement for a grant under section 1921 is that the State involved
p.001317: will ensure that prevention, treatment, and recovery personnel operating in the State’s substance use disorder
p.001317: prevention, treatment, and recovery systems have an opportunity to receive training, on an ongoing basis,
p.001317: concerning—
p.001317: (1) recent trends in substance use disorders in the State;
p.001317: (2) improved methods and evidence-based practices for pro- viding substance use disorder prevention and treatment
p.001317: serv- ices;
p.001317: (3) performance-based accountability;
p.001317: (4) data collection and reporting requirements; and
p.001317: (5) any other matters that would serve to further improve the delivery of substance use disorder prevention and
p.001317: treat- ment services within the State.
p.001317: (c) COORDINATION OF VARIOUS ACTIVITIES AND SERVICES.—A funding agreement for a grant under section 1921 is
p.001317: that the State involved will coordinate prevention and treatment activities with the provision of other
p.001317: appropriate services (including health, social, correctional and criminal justice, educational, vocational rehabilita-
p.001317: tion, and employment services).
p.001317:
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p.001317: January 30, 2020
p.001317: 6 So in law. See section 202 of Public Law 102–321 (106 Stat. 396). Probably should be ‘‘woman’’.
p.001317: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001317:
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p.001317:
p.001317: Sec. 1930 PUBLIC HEALTH SERVICE ACT 1318
p.001317:
p.001317: (d) 8 WAIVER OF REQUIREMENT.—
p.001317: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may provide to a State a waiver of any or all of
p.001317: the re- quirements established in this section if the Secretary deter- mines that, with respect to
p.001317: services for the prevention and treatment of substance use disorders, the requirement involved is unnecessary for
p.001317: maintaining quality in the provision of such services in the State.
p.001317: (2) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001317: under para- graph (1) not later than 120 days after the date on which the request is made.
p.001317: (3) APPLICABILITY OF WAIVER.—Any waiver provided by the Secretary under paragraph (1) shall be applicable only
p.001317: to the fiscal year involved.
p.001317: øSection 1929 was repealed by section 8002(f) of Public Law 114–255.¿
p.001317: SEC. 1930. ø300x–30¿ MAINTENANCE OF EFFORT REGARDING STATE EX- PENDITURES.
...

p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001341:
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p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001341: January 30, 2020
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p.001341: and are frequently associated with or are a cause of other trou- blesome situations in the family; and
p.001341: (B) such problems are best approached through a variety of integrated and essential services provided to
p.001341: adolescents and their families by other family members, religious and chari- table organizations, voluntary
p.001341: associations, and other groups in the private sector as well as services provided by publicly spon- sored initiatives;
p.001341: (9) a wide array of educational, health, and supportive services are not available to adolescents with such
p.001341: problems or to their families, or when available frequently are fragmented and thus are of limited
p.001341: effectiveness in discouraging adolescent premarital sexual relations and the consequences of such rela- tions;
p.001341: (10)(A) prevention of adolescent sexual activity and adoles- cent pregnancy depends primarily upon developing strong
p.001341: fam- ily values and close family ties, and since the family is the basic social unit in which the
p.001341: values and attitudes of adoles- cents concerning sexuality and pregnancy are formed, pro- grams designed to
p.001341: deal with issues of sexuality and pregnancy will be successful to the extent that such programs encourage and
p.001341: sustain the role of the family in dealing with adolescent sexual activity and adolescent pregnancy;
p.001341: (B) Federal policy therefore should encourage the develop- ment of appropriate health, educational, and social
p.001341: services where such services are now lacking or inadequate, and the better coordination of existing
p.001341: services where they are avail- able; and
p.001341: (C) services encouraged by the Federal Government should promote the involvement of parents with their adolescent chil-
p.001341: dren, and should emphasize the provision of support by other family members, religious and charitable
p.001341: organizations, vol- untary associations, and other groups in the private sector in order to help adolescents
p.001341: and their families deal with complex issues of adolescent premarital sexual relations and the con- sequences of
p.001341: such relations; and
p.001341: (11)(A) there has been limited research concerning the so- cietal causes and consequences of adolescent pregnancy;
p.001341: (B) there is limited knowledge concerning which means of intervention are effective in mediating or
p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
...

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p.001343: Sec. 2002 PUBLIC HEALTH SERVICE ACT 1344
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p.001343:
p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
...

p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
p.001347: geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for
p.001347: pregnant adolescents and adolescent parents in such area.
...

p.001349: (16)(A) a description of—
p.001349: (i) the schedule of fees to be used in the provision of services, which shall comply with section
p.001349: 2004(c) and which shall be designed to cover all reasonable direct and indirect costs incurred by the applicant
p.001349: in providing serv- ices; and
p.001349: (ii) a corresponding schedule of discounts to be applied to the payment of such fees, which shall comply with
p.001349: sec- tion 2004(c) and which shall be adjusted on the basis of the ability of the eligible person to pay;
p.001349: (B) assurances that the applicant has made and will con- tinue to make every reasonable effort—
p.001349: (i) to secure from eligible persons payment for services in accordance with such schedules;
p.001349: (ii) to collect reimbursement for health or other serv- ices provided to persons who are entitled to have
p.001349: payment made on their behalf for such services under any Federal or other government program or private
p.001349: insurance pro- gram; and
p.001349: (iii) to seek such reimbursement on the basis of the full amount of fees for services without
p.001349: application of any discount; and
p.001349: (C) assurances that the applicant has submitted or will submit to the Secretary such reports as the Secretary
p.001349: may re- quire to determine compliance with this paragraph;
p.001349: (17) assurances that the applicant will make maximum use of funds available under title X of this Act;
p.001349: (18) assurances that the acceptance by any individual of family planning services or family planning
p.001349: information (in- cluding educational materials) provided through financial as- sistance under this title
p.001349: shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service fur-
p.001349: nished by the applicant;
p.001349: (19) assurances that fees collected by the applicant for services rendered in accordance with this title shall
p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
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p.001413: safety and care for persons using such materials;
p.001413: (3) may support—
p.001413: (A) AIDS research conducted outside the United States by qualified foreign professionals if such
p.001413: research can reasonably be expected to benefit the people of the United States;
p.001413: (B) collaborative research involving American and for- eign participants; and
p.001413: (C) the training of American scientists abroad and for- eign scientists in the United States;
p.001413: (4) may encourage and coordinate AIDS research con- ducted by any industrial concern that evidences
p.001413: a particular capability for the conduct of such research;
p.001413: (5)(A) may acquire, improve, repair, operate, and maintain laboratories, other research facilities, equipment,
p.001413: and such other real or personal property as the Director of the Office de- termines necessary;
p.001413: (B) may make grants for the construction or renovation of facilities; and
p.001413: (C) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34) by lease or otherwise through the
p.001413: Adminis- trator of General Services, buildings or parts of buildings in the District of Columbia or
p.001413: communities located adjacent to the District of Columbia for the use of the National Institutes of Health for
p.001413: a period not to exceed ten years; and
p.001413: (6) subject to section 405(b)(2) and without regard to sec- tion 3324 of title 31, United States Code,
p.001413: and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such con- tracts and cooperative
p.001413: agreements with any public agency, or with any person, firm, association, corporation, or educational
p.001413: institution, as may be necessary to expedite and coordinate re- search relating to acquired immune deficiency syndrome.
p.001413: (b) PROJECTS FOR COOPERATION AMONG PUBLIC AND PRIVATE HEALTH ENTITIES.—In carrying out subsection (a), the
p.001413: Director of the Office shall establish projects to promote cooperation among Federal agencies, State,
p.001413: local, and regional public health agencies, and private entities, in research concerning the diagnosis,
p.001413: preven- tion, and treatment of acquired immune deficiency syndrome.
p.001413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001413:
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p.001415: 1415
p.001415: PUBLIC HEALTH SERVICE ACT
p.001415: Sec. 2356
p.001415:
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p.001415:
p.001415: January 30, 2020
p.001415: Subpart II—Emergency Discretionary Fund
p.001415: SEC. 2356. ø300cc–43¿ EMERGENCY DISCRETIONARY FUND.
p.001415: (a) IN GENERAL.—
...

p.001435: abusers, the State will place priority on activities under this part di- rected at such substance abusers;
p.001435: (5) with respect to a State in which there is a significant incidence of reported cases of acquired immune
p.001435: deficiency syn- drome, the State will—
p.001435: (A) for the purpose described in subsection (b) of sec- tion 2501, expend not less than 50 percent of payments
p.001435: re- ceived under subsection (a) of such section for a fiscal year—
p.001435: (i) to make grants to public entities, to migrant health centers (as defined in section 329(a)), to
p.001435: com- munity health centers (as defined in section 330(a)) 3, and to nonprofit private entities concerned
p.001435: with ac- quired immune deficiency syndrome; or
p.001435: (ii) to enter into contracts with public and private entities; and
p.001435: (B) of the amounts reserved for a fiscal year by the State for expenditures required in subparagraph
p.001435: (A), ex- pend not less than 50 percent to carry out section 2502(10) through grants to nonprofit private
p.001435: entities, including mi- nority entities, concerned with acquired immune deficiency syndrome located in and
p.001435: representative of communities and subpopulations reflecting the local incidence of such syndrome;
p.001435: (6) with respect to programs carried out pursuant to sec- tion 2502(10), the State will ensure that any
p.001435: applicant for a grant under such section agrees—
p.001435: (A) that any educational or informational materials developed with a grant pursuant to such section will
p.001435: con- tain material, and be presented in a manner, that is spe- cifically directed toward the group for
p.001435: which such mate- rials are intended;
p.001435: (B) to provide a description of the manner in which the applicant has planned the program in
p.001435: consultation with, and of the manner in which such applicant will con- sult during the conduct of the program with—
p.001435: (i) appropriate local officials and community groups for the area to be served by the program;
p.001435: (ii) organizations comprised of, and representing, the specific population to which the education or pre-
p.001435: vention effort is to be directed; and
p.001435: (iii) individuals having expertise in health edu- cation and in the needs of the population to be served;
p.001435: (C) to provide information demonstrating that the ap- plicant has continuing relationships, or will
p.001435: establish con-
p.001435:
p.001435:
p.001435:
p.001435: January 30, 2020
p.001435: 3 See footnote for section 217(a).
p.001435:
p.001435: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001435:
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p.001435: Sec. 2507 PUBLIC HEALTH SERVICE ACT 1436
p.001435:
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p.001439: are authorized to be appropriated $165,000,000 for fiscal year 1989 and such sums as may be necessary for
p.001439: each of the fiscal years 1990 and 1991.
p.001439: (b) AVAILABILITY TO STATES.—Any amounts paid to a State under section 2501(a) shall remain available to the
p.001439: State until the expiration of the 1-year period beginning on the date on which the State receives such amounts.
p.001439: PART B—NATIONAL INFORMATION PROGRAMS
p.001439: SEC. 2521. ø300ee–31¿ AVAILABILITY OF INFORMATION TO GENERAL PUBLIC.
p.001439: (a) COMPREHENSIVE INFORMATION PLAN.—The Secretary, act- ing through the Director of the Centers for
p.001439: Disease Control and Prevention, shall annually prepare a comprehensive plan, including a budget, for a National
p.001439: Acquired Immune Deficiency Syndrome In- formation Program. The plan shall contain provisions to implement the
p.001439: provisions of this title. The Director shall submit such plan to the Secretary. The authority established in
p.001439: this subsection may not be construed to be the exclusive authority for the Director to carry out information
p.001439: activities with respect to acquired immune defi- ciency syndrome.
p.001439: (b) CLEARINGHOUSE.—
p.001439: (1) The Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention, may establish a
p.001439: clear- inghouse to make information concerning acquired immune de- ficiency syndrome available to Federal agencies,
p.001439: States, public and private entities, and the general public.
p.001439: (2) The clearinghouse may conduct or support programs—
p.001439: (A) to develop and obtain educational materials, model curricula, and methods directed toward reducing the trans-
p.001439: mission of the etiologic agent for acquired immune defi- ciency syndrome;
p.001439: (B) to provide instruction and support for individuals who provide instruction in methods and techniques of edu-
p.001439: cation relating to the prevention of acquired immune defi-
p.001439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001439:
p.001439:
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p.001439:
p.001441: 1441
p.001441: PUBLIC HEALTH SERVICE ACT
p.001441: Sec. 2523
p.001441:
p.001441: ciency syndrome and instruction in the use of the mate- rials and curricula described in subparagraph (A); and
p.001441: (C) to conduct, or to provide for the conduct of, the ma- terials, curricula, and methods described in paragraph
p.001441: (1) and the efficacy of such materials, curricula, and methods in preventing infection with the the 4 etiologic agent
p.001441: for ac- quired immune deficiency syndrome.
p.001441: (c) TOLL-FREE TELEPHONE COMMUNICATIONS.—The Secretary shall provide for the establishment and maintenance
p.001441: of toll-free telephone communications to provide information to, and respond to queries from, the public
p.001441: concerning acquired immune deficiency syndrome. Such communications shall be available on a 24-hour basis.
p.001441: SEC. 2522. ø300ee–32¿ PUBLIC INFORMATION CAMPAIGNS.
p.001441: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
...

p.001583: respect to services for substance use disorders, as defined under the terms of the plan and in
p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001583:
p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
...

p.001585: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–438).
p.001585: Subsection (c) of such section 903 concerns effec- tive dates, and paragraph (1) of the subsection provides as follows:
p.001585: ‘‘(1) GROUP PLANS.—
p.001585: ‘‘(A) IN GENERAL.—The amendment made by subsection (a) shall apply to group health plans for plan years
p.001585: beginning on or after the date of enactment of this Act.
p.001585: ‘‘(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group
p.001585: health plan maintained pursuant to 1 or more collective bargaining agreements be- tween employee
p.001585: representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining
p.001585: agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment
p.001585: made by subsection
p.001585: (a) shall not be treated as a termination of such collective bargaining agreement.’’.
p.001585: The Public Law was enacted October 21, 1998.
p.001585: 13 So in law.
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
p.001585:
p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
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p.001651: may not be in- cluded in determining the amount of such non-Federal con- tributions.
p.001651: (g) TERM OF GRANTS OR COOPERATIVE AGREEMENTS.—
p.001651: (1) IN GENERAL.—The Secretary shall award grants or co- operative agreements under this section for terms
p.001651: that do not exceed 5 years.
p.001651: (2) RENEWAL.—The Secretary may renew a grant or coop- erative agreement under this section at the end of the
p.001651: term of the grant or cooperative agreement determined under para- graph (1).
p.001651: (h) MAINTENANCE OF EFFORT.—Funds made available under this section shall be used to supplement and not
p.001651: supplant other Federal, State, and local funds available for respite care services.
p.001651: SEC. 2903. ø300ii–2¿ NATIONAL LIFESPAN RESPITE RESOURCE CENTER.
p.001651: (a) ESTABLISHMENT.—The Secretary may award a grant or co- operative agreement to a public or private nonprofit
p.001651: entity to estab- lish a National Resource Center on Lifespan Respite Care (referred to in this section as the
p.001651: ‘‘center’’).
p.001651: (b) PURPOSES OF THE CENTER.—The center shall—
p.001651: (1) maintain a national database on lifespan respite care;
p.001651: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001651:
p.001651:
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p.001651:
p.001651:
p.001653: 1653
p.001653: PUBLIC HEALTH SERVICE ACT
p.001653: Sec. 3000
p.001653:
p.001653: (2) provide training and technical assistance to State, com- munity, and nonprofit respite care programs; and
p.001653: (3) provide information, referral, and educational programs to the public on lifespan respite care.
p.001653: SEC. 2904. ø300ii–3¿ REPORT.
p.001653: Not later than January 1, 2009, the Secretary shall report to the Congress on the activities undertaken under
p.001653: this title. Such re- port shall evaluate—
p.001653: (1) the number of States that have lifespan respite care programs;
p.001653: (2) the demographics of the caregivers receiving respite care services through grants or cooperative
p.001653: agreements under this title; and
p.001653: (3) the effectiveness of entities receiving grants or coopera- tive agreements under this title.
p.001653: SEC. 2905. ø300ii–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.001653: There are authorized to be appropriated to carry out this title—
p.001653: (1) $30,000,000 for fiscal year 2007;
p.001653: (2) $40,000,000 for fiscal year 2008;
p.001653: (3) $53,330,000 for fiscal year 2009;
p.001653: (4) $71,110,000 for fiscal year 2010; and (5) $94,810,000 for fiscal year 2011.
p.001653:
p.001653: TITLE XXX—HEALTH INFORMATION TECHNOLOGY AND QUALITY
p.001653:
p.001653:
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p.001653:
p.001653: January 30, 2020
p.001653: SEC. 3000. ø300jj¿ DEFINITIONS.
p.001653: In this title:
p.001653: (1) CERTIFIED EHR TECHNOLOGY.—The term ‘‘certified EHR technology’’ means a qualified electronic health record
p.001653: that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are
p.001653: applicable to the type of record involved (as determined by the Secretary, such as an ambulatory
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p.001341: (1) in 1978, an estimated one million one hundred thou- sand teenagers became pregnant, more than
p.001341: five hundred thousand teenagers carried their babies to term, and over one- half of the babies born to such teenagers
p.001341: were born out of wed- lock;
p.001341: (2) adolescents aged seventeen and younger accounted for more than one-half of the out of wedlock births
p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
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p.000813: (b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DO- NATION FOR USE IN TRANSPLANTATION.—It shall
p.000813: be unlawful for any person to solicit or knowingly acquire, receive, or accept a do- nation of human
p.000813: fetal tissue for the purpose of transplantation of such tissue into another person if the donation
p.000813: affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
p.000813: (1) the donation will be or is made pursuant to a promise to the donating individual that the donated
p.000813: tissue will be transplanted into a recipient specified by such individual;
p.000813: (2) the donated tissue will be transplanted into a relative of the donating individual; or
p.000813: (3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable
p.000813: consideration for the costs associated with such abortion.
p.000813: (c) SOLICITATION OR ACCEPTANCE OF TISSUE FROM FETUSES GESTATED FOR RESEARCH PURPOSES.—It shall be
p.000813: unlawful for any person or entity involved or engaged in interstate commerce to—
p.000813: (1) solicit or knowingly acquire, receive, or accept a dona- tion of human fetal tissue knowing that a
p.000813: human pregnancy was deliberately initiated to provide such tissue; or
p.000813: (2) knowingly acquire, receive, or accept tissue or cells ob- tained from a human embryo or fetus that was gestated in
p.000813: the uterus of a nonhuman animal.
p.000813: (d) CRIMINAL PENALTIES FOR VIOLATIONS.—
p.000813: (1) IN GENERAL.—Any person who violates subsection (a), (b), or (c) shall be fined in accordance with
p.000813: title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
p.000813: (2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID- ERATION.—With respect to the imposition of a fine under
p.000813: para- graph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an
p.000813: amount not less than twice the amount of the valuable consideration received.
p.000813: (e) DEFINITIONS.—For purposes of this section:
p.000813: (1) The term ‘‘human fetal tissue’’ has the meaning given such term in section 498A(g).
p.000813: (2) The term ‘‘interstate commerce’’ has the meaning given such term in section 201(b) of the Federal Food,
p.000813: Drug, and Cosmetic Act.
p.000813: (3) The term ‘‘valuable consideration’’ does not include rea- sonable payments associated with the transportation,
p.000813: implan- tation, processing, preservation, quality control, or storage of human fetal tissue.
p.000813: SEC. 498C. ø289g–3¿ BREAST IMPLANT RESEARCH.
p.000813: (a) IN GENERAL.—The Director of NIH may conduct or support research to examine the long-term health implications
p.000813: of silicone
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000813:
p.000813:
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p.001551: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1552
p.001551:
p.001551: with a group health plan, shall not request, require, or pur- chase genetic information for underwriting
p.001551: purposes (as de- fined in section 2791).
p.001551: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A group health plan, and a health in-
p.001551: surance issuer offering health insurance coverage in connection with a group health plan, shall not request,
p.001551: require, or pur- chase genetic information with respect to any individual prior to such individual’s
p.001551: enrollment under the plan or coverage in connection with such enrollment.
p.001551: (3) INCIDENTAL COLLECTION.—If a group health plan, or a health insurance issuer offering health insurance
p.001551: coverage in connection with a group health plan, obtains genetic informa- tion incidental to the
p.001551: requesting, requiring, or purchasing of other information concerning any individual, such request, re-
p.001551: quirement, or purchase shall not be considered a violation of paragraph (2) if such request, requirement, or
p.001551: purchase is not in violation of paragraph (1).
p.001551: (e) APPLICATION TO ALL PLANS.—The provisions of subsections (a)(6), (b)(3), (c), and (d) and subsection (b)(1) and
p.001551: section 2704 with respect to genetic information, shall apply to group health plans and health insurance
p.001551: issuers without regard to section 2735(a).
p.001551: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001551: individual or family member of an individual shall—
p.001551: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001551: infor- mation of any fetus carried by such pregnant woman; and
p.001551: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001551: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001551: (j) 5 PROGRAMS OF HEALTH PROMOTION OR DISEASE PREVEN-
p.001551: TION.—
p.001551: (1) GENERAL PROVISIONS.—
p.001551: (A) GENERAL RULE.—For purposes of subsection (b)(2)(B), a program of health promotion or disease preven-
p.001551: tion (referred to in this subsection as a ‘‘wellness pro- gram’’) shall be a program offered by an
p.001551: employer that is designed to promote health or prevent disease that meets the applicable requirements of this
p.001551: subsection.
p.001551: (B) NO CONDITIONS BASED ON HEALTH STATUS FAC- TOR.—If none of the conditions for obtaining a
p.001551: premium discount or rebate or other reward for participation in a wellness program is based on an
p.001551: individual satisfying a standard that is related to a health status factor, such wellness program shall not
p.001551: violate this section if participa- tion in the program is made available to all similarly situ- ated individuals and
p.001551: the requirements of paragraph (2) are complied with.
p.001551: (C) CONDITIONS BASED ON HEALTH STATUS FACTOR.—If any of the conditions for obtaining a premium discount or
p.001551:
p.001551:
p.001551:
p.001551: January 30, 2020
p.001551: 5 So in law. There are no subsections (g)–(i).
p.001551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001553: 1553
p.001553: PUBLIC HEALTH SERVICE ACT
p.001553: Sec. 2705
p.001553:
p.001553:
p.001553:
p.001553:
p.001553:
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p.001609: (C) No genetic information collected or acquired under this paragraph shall be used for underwriting purposes.
p.001609: (D) The issuer notifies the Secretary in writing that the issuer is conducting activities pursuant to
p.001609: the excep- tion provided for under this paragraph, including a de- scription of the activities conducted.
p.001609: (E) The issuer complies with such other conditions as the Secretary may by regulation require for activities
p.001609: con- ducted under this paragraph.
p.001609: (e) PROHIBITION ON COLLECTION OF GENETIC INFORMATION.—
p.001609: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market shall not
p.001609: request, require, or purchase genetic information for underwriting pur- poses (as defined in section 2791).
p.001609: (2) PROHIBITION ON COLLECTION OF GENETIC INFORMATION PRIOR TO ENROLLMENT.—A health insurance issuer
p.001609: offering health insurance coverage in the individual market shall not request, require, or purchase genetic
p.001609: information with respect to any individual prior to such individual’s enrollment under the plan in
p.001609: connection with such enrollment.
p.001609: (3) INCIDENTAL COLLECTION.—If a health insurance issuer offering health insurance coverage in the individual
p.001609: market ob- tains genetic information incidental to the requesting, requir- ing, or purchasing of other
p.001609: information concerning any indi- vidual, such request, requirement, or purchase shall not be considered a
p.001609: violation of paragraph (2) if such request, require- ment, or purchase is not in violation of paragraph (1).
p.001609: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001609: individual or family member of an individual shall—
p.001609: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001609: infor- mation of any fetus carried by such pregnant woman; and
p.001609: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001609: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001609:
p.001609:
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p.001609:
p.001609: Sec. 2761 PUBLIC HEALTH SERVICE ACT 1610
p.001609:
p.001609: Subpart 3—General Provisions 25
p.001609: SEC. 2761. ø300gg–61¿ ENFORCEMENT.
p.001609: (a) STATE ENFORCEMENT.—
p.001609: (1) STATE AUTHORITY.—Subject to section 2762, each State may require that health insurance issuers that issue,
p.001609: sell, renew, or offer health insurance coverage in the State in the individual market meet the
p.001609: requirements established under this part with respect to such issuers.
p.001609: (2) FAILURE TO IMPLEMENT REQUIREMENTS.—In the case of a State that fails to substantially enforce the requirements
p.001609: set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the
p.001609: requirements of this part under subsection (b) insofar as they relate to the issuance, sale, renewal, and offering of
p.001609: health insurance coverage in the individual market in such State.
p.001609: (b) SECRETARIAL ENFORCEMENT AUTHORITY.—The Secretary shall have the same authority in relation to enforcement
p.001609: of the pro- visions of this part with respect to issuers of health insurance cov- erage in the individual market
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p.000001: (2) For provisions relating to the receipt of special pay by com- missioned officers of the Regular and Reserve Corps
p.000001: while on active duty, see section 303a(b) or 373 of title 37, United States Code.
p.000001: (b) Commissioned officers on active duty, and retired officers entitled to retired pay pursuant to section
p.000001: 210(g)(3), section 211 or section 221(a), shall be permitted to purchase supplies from the Army, Navy, Air
p.000001: Force, and Marine Corps at the same price as is charged officers thereof.
p.000001: (c) Members of the National Advisory Health Council and members of other national advisory or review
p.000001: councils or commit- tees established under this Act, including members of the Technical Electronic Product Radiation
p.000001: Safety Standards Committee and the Board of Regents of the National Library of Medicine, but exclud- ing ex
p.000001: officio members, while attending conferences or meetings of their respective councils or committees or while
p.000001: otherwise serving at the request of the Secretary shall be entitled to receive com- pensation at rates to
p.000001: be fixed by the Secretary, but at rates not ex- ceeding the daily equivalent of the rate specified at the
p.000001: time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from
p.000001: their homes or regular places of business they may be allowed travel expenses, including per diem in lieu
p.000001: of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government
p.000001: service em- ployed intermittently.
p.000001: (d) Field employees of the Service, except those employed on a
p.000001: per diem or fee basis, who render part-time duty and are also sub- ject to call at any time for services not
p.000001: contemplated in their reg- ular part-time employment, may be paid annual compensation for such part-time
p.000001: duty and, in addition, such fees for such other serv- ices as the Surgeon General may determine; but in no
p.000001: case shall the total paid to any such employee for any fiscal year exceed the
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 209 PUBLIC HEALTH SERVICE ACT 12
p.000001:
p.000001: amount of the minimum annual salary rate of the classification grade of the employee.
p.000001: (e) Any civilian employee of the Service who is employed at the Gillis W. Long Hansen’s Disease Center on the
p.000001: date of the enact- ment of the Consolidated Omnibus Budget Reconciliation Act of 1985 shall be entitled
p.000001: to receive, in addition to any compensation to which the employee may otherwise be entitled and for so
p.000001: long as the employee remains employed at the Center, an amount equal to one-fourth of such compensation.
p.000001: (f) Individuals appointed under subsection (g) shall have in- cluded in their fellowships such stipends
p.000001: or allowances, including travel and subsistence expenses, as the Surgeon General may deem necessary to procure
p.000001: qualified fellows.
...

p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
p.000001: color, sex, ethnicity, age, religion, and disability.
p.000001: PRESENTATION OF UNITED STATES FLAG UPON RETIREMENT
p.000001: SEC. 213. ø214¿ (a) PRESENTATION OF FLAG.—Upon the release of an officer of the commissioned corps of the
p.000001: Service from active commissioned service for retirement, the Secretary of Health and Human Services shall
p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
p.000001: applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive
p.000001: depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for
p.000001: the government of the service to which detailed.
p.000001: (b) Upon the request of any State health authority or, in the case of work relating to mental health, any
p.000001: State mental health au-
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 7 Former section 213 was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Section 415(c) of title 37, United
p.000001: States Code, now applies to the matter with which former section 213 was concerned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 21 PUBLIC HEALTH SERVICE ACT Sec. 216
p.000001:
p.000001: thority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such
p.000001: State or political subdivi- sion thereof in work related to the functions of the Service.
p.000001: (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to
...

p.000001: the Service. The services of personnel while detailed pursuant to this section shall be considered as having
p.000001: been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa-
p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
p.000001: may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned
p.000001: under this section to an entity outside of the Department of Health and Human Services for service under
p.000001: the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined
p.000001: in section 203A(a)(5)).
p.000001:
p.000001: REGULATIONS
p.000001: SEC. 215. ø216¿ (a) The President shall from time to time pre- scribe regulations with respect to the
p.000001: appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances
p.000001: (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service.
p.000001: (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall
p.000001: promulgate all other regulations necessary to the administration of the Service, includ- ing regulations
p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
p.000001: SEC. 216. ø217¿ In time of war, or of emergency proclaimed by the President, he may utilize the Service to such
p.000001: extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency
p.000001: involving the national defense pro-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 217 PUBLIC HEALTH SERVICE ACT 22
p.000001:
p.000001: claimed by the President, he may by Executive order declare the commissioned corps of the Service to be
p.000001: a military service. Upon such declaration, and during the period of such war or such emer- gency or such part
p.000001: thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the
p.000001: land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President,
...

p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
p.000001: full-time employees of the United States shall, while attending meetings or conferences of such council or
p.000001: committee or otherwise engaged on business of such council or committee receive compensation and allowances as
p.000001: pro- vided in section 208(c) for members of national advisory councils established under this Act.
p.000001: (c) Upon appointment of any such council or committee, the Secretary may delegate to such council or committee
p.000001: such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas
p.000001: or fields with which such council or com- mittee is concerned, as the Secretary determines to be appropriate.
p.000001: VOLUNTEER SERVICES
p.000001: SEC. 223. ø217b¿ Subject to regulations, volunteer and uncom- pensated services may be accepted by the
p.000001: Secretary, or by any other officer or employee of the Department of Health and Human Services designated by him, for
p.000001: use in the operation of any health care facility or in the provision of health care.
p.000001:
p.000001: January 30, 2020 As Amended Through P.L. 116-94,
p.000001: Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 26
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p.000001: paragraph (4) only if—
p.000001: (A) the individual normally performs on average at least 321⁄2 hours of service per week for the entity
p.000001: for the period of the contract; or
p.000001: (B) in the case of an individual who normally performs an average of less than 321⁄2 hours of services per week for the
p.000001: en- tity for the period of the contract, the individual is a licensed or certified provider of services in
p.000001: the fields of family practice, general internal medicine, general pediatrics, or obstetrics and gynecology.
p.000001: (h) The Secretary may not approve an application under sub- section (g)(1)(D) unless the Secretary
p.000001: determines that the entity—
p.000001: (1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits
p.000001: arising out of any health or health-related functions performed by the entity;
p.000001: (2) has reviewed and verified the professional credentials, references, claims history, fitness,
p.000001: professional review organi- zation findings, and license status of its physicians and other licensed or
p.000001: certified health care practitioners, and, where nec- essary, has obtained the permission from these
p.000001: individuals to gain access to this information;
p.000001: (3) has no history of claims having been filed against the United States as a result of the
p.000001: application of this section to the entity or its officers, employees, or contractors as provided for under this
p.000001: section, or, if such a history exists, has fully co- operated with the Attorney General in defending against
p.000001: any such claims and either has taken, or will take, any necessary corrective steps to assure against
p.000001: such claims in the future; and
p.000001: (4) will fully cooperate with the Attorney General in pro-
p.000001: viding information relating to an estimate described under sub- section (k).
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 10 So in law. See section 5(a) of Public Law 104–73 (109 Stat. 779). There is no closing paren- thesis.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 30
p.000001: (i)(1) Notwithstanding subsection (g)(1), the Attorney General, in consultation with the Secretary, may on
p.000001: the record determine, after notice and opportunity for a full and fair hearing, that an in- dividual physician or
p.000001: other licensed or certified health care practi- tioner who is an officer, employee, or contractor of an
p.000001: entity de- scribed in subsection (g)(4) shall not be deemed to be an employee of the Public Health Service for
p.000001: purposes of this section, if treating such individual as such an employee would expose the Government to an
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p.000001: the Attorney General, or an applicant for or recipient of funds under this Act; or
p.000001: (E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national
p.000001: professional society.
p.000001: (2) A final determination by the Attorney General under this subsection that an individual physician or
p.000001: other licensed or cer- tified health care professional shall not be deemed to be an em- ployee of the
p.000001: Public Health Service shall be effective upon receipt by the entity employing such individual of notice
p.000001: of such deter- mination, and shall apply only to acts or omissions occurring after the date such notice is received.
p.000001: (j) In the case of a health care provider who is an officer, em- ployee, or contractor of an entity
p.000001: described in subsection (g)(4), sec- tion 335(e) shall apply with respect to the provider to the same ex- tent and in
p.000001: the same manner as such section applies to any mem- ber of the National Health Service Corps.
p.000001: (k)(1)(A) For each fiscal year, the Attorney General, in con- sultation with the Secretary, shall estimate by
p.000001: the beginning of the year the amount of all claims which are expected to arise under this section
p.000001: (together with related fees and expenses of witnesses) for which payment is expected to be made in
p.000001: accordance with sec- tion 1346 and chapter 171 of title 28, United States Code, from the acts or omissions, during
p.000001: the calendar year that begins during that fiscal year, of entities described in subsection (g)(4) and of officers,
p.000001: employees, or contractors (subject to subsection (g)(5)) of such enti- ties.
p.000001: (B) The estimate under subparagraph (A) shall take into ac- count—
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: (i) the value and frequency of all claims for damage for personal injury, including death, resulting
p.000001: from the perform- ance of medical, surgical, dental, or related functions by enti- ties described in
p.000001: subsection (g)(4) or by officers, employees, or contractors (subject to subsection (g)(5)) of such
p.000001: entities who
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001: 31 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: are deemed to be employees of the Public Health Service under subsection (g)(1) that, during the preceding 5-year
p.000001: period, are filed under this section or, with respect to years occurring be- fore this subsection takes
p.000001: effect, are filed against persons other than the United States,
p.000001: (ii) the amounts paid during that 5-year period on all claims described in clause (i), regardless of
p.000001: when such claims were filed, adjusted to reflect payments which would not be permitted under section 1346
p.000001: and chapter 171 of title 28,
p.000001: United States Code, and
p.000001: (iii) amounts in the fund established under paragraph (2) but unspent from prior fiscal years.
p.000001: (2) Subject to appropriations, for each fiscal year, the Secretary shall establish a fund of an amount equal to the
p.000001: amount estimated under paragraph (1) that is attributable to entities receiving funds under each of the grant
p.000001: programs described in paragraph (4) of subsection (g), but not to exceed a total of $10,000,000 for
p.000001: each such fiscal year. Appropriations for purposes of this paragraph shall be made separate from
p.000001: appropriations made for purposes of sections 329, 330 and 340A.
p.000001: (3) In order for payments to be made for judgments against the United States (together with related fees and
p.000001: expenses of wit- nesses) pursuant to this section arising from the acts or omissions of entities described in
p.000001: subsection (g)(4) and of officers, 11 employ- ees, or contractors (subject to subsection (g)(5)) of such entities,
p.000001: the total amount contained within the fund established by the Sec- retary under paragraph (2) for a fiscal
p.000001: year shall be transferred not later than the December 31 that occurs during the fiscal year to the
...

p.000001: the entity and any officer, governing board member, employee, or contractor of the entity as meeting whatever
p.000001: malpractice coverage requirements such plan may require of contracting providers for a calendar year if such
p.000001: entity or officer, governing board member, employee, or con- tractor of the entity has been deemed to be an employee of
p.000001: the Pub- lic Health Service for purposes of this section for such calendar year. Any plan which is found by
p.000001: the Secretary on the record, after notice and an opportunity for a full and fair hearing, to have vio-
p.000001: lated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to
p.000001: be eligible to re- ceive any Federal funds under titles XVIII or XIX of the Social Se- curity Act.
p.000001: (3) For purposes of this subsection, the term ‘‘managed care plan’’ shall mean health maintenance
p.000001: organizations and similar en- tities that contract at-risk with payors for the provision of health services
p.000001: or plan enrollees and which contract with providers (such as entities described in subsection (g)(4)) for
p.000001: the delivery of such services to plan enrollees.
p.000001: (n)(1) Not later than one year after the date of the enactment of the Federally Supported Health Centers
p.000001: Assistance Act of 1995, the Comptroller General of the United States shall submit to the Congress a report on
p.000001: the following:
p.000001: (A) The medical malpractice liability claims experience of entities that have been deemed to be employees
p.000001: for purposes of this section.
p.000001: (B) The risk exposure of such entities.
p.000001: (C) The value of private sector risk-management services, and the value of risk-management services and
p.000001: procedures re- quired as a condition of receiving a grant under section 329, 330, or 340A.
p.000001: (D) A comparison of the costs and the benefits to taxpayers of maintaining medical malpractice liability coverage
p.000001: for such entities pursuant to this section, taking into account—
p.000001: (i) a comparison of the costs of premiums paid by such entities for private medical malpractice liability
p.000001: insurance with the cost of coverage pursuant to this section; and
p.000001: (ii) an analysis of whether the cost of premiums for private medical malpractice liability insurance coverage
p.000001: is consistent with the liability claims experience of such enti- ties.
p.000001: (2) The report under paragraph (1) shall include the following:
p.000001: (A) A comparison of—
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 33 PUBLIC HEALTH SERVICE ACT Sec. 224
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p.000001: January 30, 2020
p.000001: (i) an estimate of the aggregate amounts that such en- tities (together with the officers, governing board mem-
p.000001: bers, employees, and contractors of such entities who have been deemed to be employees for purposes of this
p.000001: section) would have directly or indirectly paid in premiums to ob- tain medical malpractice liability
p.000001: insurance coverage if this section were not in effect; with
p.000001: (ii) the aggregate amounts by which the grants re- ceived by such entities under this Act were reduced pursu-
p.000001: ant to subsection (k)(2).
p.000001: (B) A comparison of—
p.000001: (i) an estimate of the amount of privately offered such insurance that such entities (together with the
p.000001: officers, governing board members, employees, and contractors of such entities who have been deemed to be
p.000001: employees for purposes of this section) purchased during the three-year period beginning on January 1, 1993;
p.000001: with
p.000001: (ii) an estimate of the amount of such insurance that such entities (together with the officers,
p.000001: governing board members, employees, and contractors of such entities who have been deemed to be employees for
p.000001: purposes of this sec- tion) will purchase after the date of the enactment of the Federally Supported
p.000001: Health Centers Assistance Act of 1995.
p.000001: (C) An estimate of the medical malpractice liability loss history of such entities for the 10-year
p.000001: period preceding Octo- ber 1, 1996, including but not limited to the following:
p.000001: (i) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims
p.000001: that have been paid and that are estimated to be paid, by the Federal Government pursuant to deeming
p.000001: entities as em- ployees for purposes of this section.
p.000001: (ii) Claims that have been paid and that are estimated to be paid, and legal expenses to handle such claims
p.000001: that have been paid and that are estimated to be paid, by pri- vate medical malpractice liability insurance.
p.000001: (D) An analysis of whether the cost of premiums for pri- vate medical malpractice liability insurance
p.000001: coverage is con- sistent with the liability claims experience of entities that have been deemed as employees for
p.000001: purposes of this section.
p.000001: (3) In preparing the report under paragraph (1), the Comp- troller General of the United States shall
p.000001: consult with public and private entities with expertise on the matters with which the re- port is
p.000001: concerned.
p.000001: (o)(1) For purposes of this section, a free clinic health profes- sional shall in providing a qualifying
p.000001: health service to an indi- vidual, or an officer, governing board member, employee, or con- tractor of a
p.000001: free clinic shall in providing services for the free clinic, be deemed to be an employee of the Public Health Service
p.000001: for a cal- endar year that begins during a fiscal year for which a transfer was made under paragraph
p.000001: (6)(D). The preceding sentence is sub- ject to the provisions of this subsection.
p.000001: (2) In providing a health service to an individual, a health care practitioner shall for purposes of this
p.000001: subsection be considered to
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 34
p.000001: be a free clinic health professional if the following conditions are met:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
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p.000001: submit to the Con- gress a report providing an estimate of the amount of claims (to- gether with related
p.000001: fees and expenses of witnesses) that, by reason of the acts or omissions of free clinic health professionals,
p.000001: will be
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 36
p.000001:
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p.000001: January 30, 2020
p.000001:
p.000001: paid pursuant to this section during the calendar year that begins in the following fiscal year. Subsection (k)(1)(B)
p.000001: applies to the esti- mate under the preceding sentence regarding free clinic health pro- fessionals to the same extent
p.000001: and in the same manner as such sub- section applies to the estimate under such subsection regarding of- ficers,
p.000001: governing board members, employees, and contractors of en- tities described in subsection (g)(4).
p.000001: (D) Not later than December 31 of each fiscal year, the Sec- retary shall transfer from the fund under
p.000001: subparagraph (B) to the appropriate accounts in the Treasury an amount equal to the esti- mate made under
p.000001: subparagraph (C) for the calendar year begin- ning in such fiscal year, subject to the extent of
p.000001: amounts in the fund.
p.000001: (7)(A) This subsection takes effect on the date of the enactment of the first appropriations Act that makes an
p.000001: appropriation under paragraph (6)(A), except as provided in subparagraph (B)(i).
p.000001: (B)(i) Effective on the date of the enactment of the Health In- surance Portability and Accountability Act
p.000001: of 1996—
p.000001: (I) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and
p.000001: consider ap- plications submitted pursuant to paragraph (5)(C); and
p.000001: (II) reports under paragraph (6)(C) may be submitted to the Congress.
p.000001: (ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of paragraph (6), if an
p.000001: estimate under sub- paragraph (C) of such paragraph has not been made for the cal- endar year beginning
p.000001: in such fiscal year, the transfer under sub- paragraph (D) of such paragraph shall be made
p.000001: notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount
p.000001: of such appropriation.
p.000001: (p) ADMINISTRATION OF SMALLPOX COUNTERMEASURES BY
p.000001: HEALTH PROFESSIONALS.—
p.000001: (1) IN GENERAL.—For purposes of this section, and subject to other provisions of this subsection, a covered person
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p.000001:
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p.000001: January 30, 2020
p.000001: mit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by
p.000001: section 44H of the Inter- nal Revenue Code of 1954; and the Secretary of Health and Human Services shall submit
p.000001: to the Board for inclusion in the annual re- port a report on the program of assistance under section
p.000001: 5 of the Orphan Drug Act for the development of drugs for rare diseases and conditions. Each annual
p.000001: report shall be submitted by June 1 of each year for the preceding calendar year.
p.000001: SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE
p.000001: SEC. 228. ø237¿ (a)(1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical
p.000001: Research and Bio- medical Product Assessment Service (in this section referred to as the ‘‘Service’’), not
p.000001: to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified
p.000001: scientific and technical experts in the fields of biomedical research, clinical re- search evaluation, and
p.000001: biomedical product assessment.
p.000001: (2) The authority established in paragraph (1) may not be con- strued to require the Secretary to reduce the number of
p.000001: employees serving under any other employment system in order to offset the number of members serving in the
p.000001: Service.
p.000001: (3) The Secretary shall assign experts under this section to agencies within the Department of Health
p.000001: and Human Services taking into account the need for the expertise of such expert.
p.000001: (b) The Service shall be appointed by the Secretary without re- gard to the provisions of title 5, United States Code,
p.000001: regarding ap- pointment, and shall consist of individuals outstanding in the field of biomedical research, clinical
p.000001: research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such
p.000001: individual (1) has earned a doctoral level degree in bio- medicine or a related field, or a doctoral or
p.000001: master’s level degree in engineering, bioinformatics, or a related or emerging field, and
p.000001: (2) meets the qualification standards prescribed by the Office of Personnel Management for appointment to
p.000001: a position at GS–15 of the General Schedule. Notwithstanding any previous applicability to an individual who
p.000001: is a member of the Service, the provisions of subchapter I of chapter 35 (relating to retention preference), chap- ter
p.000001: 43 (relating to performance appraisal and performance actions), chapter 51 (relating to classification),
p.000001: subchapter III of chapter 53 (relating to General Schedule pay rates), and chapter 75 (relating to
p.000001: adverse actions) of title 5, United States Code, shall not apply to any member of the Service.
p.000001: (c) The Secretary shall develop a performance appraisal system designed to—
p.000001: (1) provide for the systematic appraisal of the performance of members, and
p.000001: (2) encourage excellence in performance by members.
...

p.000017: 103–43.)
p.000017: 18 Now the Office of Management and Budget.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 237 PUBLIC HEALTH SERVICE ACT 52
p.000017:
p.000017: AVAILABILITY OF APPROPRIATIONS
p.000017: SEC. 237. ø238f¿ Appropriations for carrying out the purposes of this Act shall be available for
p.000017: expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and
p.000017: exhibits; printing and binding; transporting in Government- owned automotive equipment, to and from school,
p.000017: children of per- sonnel who have quarters for themselves and their families at sta- tions determined by the
p.000017: Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who
p.000017: escape from any hospital, institution, or station of the Service or from the custody of any officer or employee
p.000017: of the Service, in- cluding rewards for the capture of such prisoners; furnishing, re- pairing, and
p.000017: cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the
p.000017: performance of their official duties; reimbursing officers and employees, subject to regulations of the
p.000017: Administrator, for the cost of repairing or re- placing their personal belongings damaged or destroyed by patients
p.000017: while such officers or employees are engaged in the performance of their official duties; and maintenance of
p.000017: buildings of the National Institutes of Health.
p.000017: UNAUTHORIZED WEARING OF UNIFORMS
p.000017: SEC. 238. ø238g¿ Except as may be authorized by regulations of the President, the insignia and uniform of
p.000017: commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia
p.000017: or uniform any part of which is similar to a distinc- tive part thereof, shall not be worn, after the promulgation of
p.000017: such regulations, by any person other than a commissioned officer of the Service.
p.000017: BIANNUAL REPORT
p.000017: SEC. 239. ø238h¿ The Surgeon General shall transmit to the Secretary, for submission to the Congress, on
p.000017: January 1, 1995, and on January 1, every 2 years thereafter, a full report of the adminis- tration of the functions
p.000017: of the Service under this Act, including a detailed statement of receipts and disbursements.
p.000017: MEMORIALS AND OTHER ACKNOWLEDGMENTS
p.000017: SEC. 240. ø238i¿ The Secretary may provide for suitably ac- knowledging, within the Department (whether
p.000017: by memorials, des- ignations, or other suitable acknowledgments), (1) efforts of persons who have contributed
p.000017: substantially to the health of the Nation and
p.000017: (2) gifts for use in activities of the Department related to health.
p.000017:
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p.000017: January 30, 2020
p.000017:
p.000017: EVALUATION OF PROGRAMS
p.000017: SEC. 241. ø238j¿ (a) IN GENERAL.—Such portion as the Sec- retary shall determine, but not less than 0.2
p.000017: percent nor more than
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p.000017:
p.000017: Sec. 246 PUBLIC HEALTH SERVICE ACT 56
p.000017:
p.000017: uals who have voluntarily elected to perform abor- tions.
p.000017: (c) DEFINITIONS.—For purposes of this section:
p.000017: (1) The term ‘‘financial assistance’’, with respect to a gov- ernment program, includes governmental
p.000017: payments provided as reimbursement for carrying out health-related activities.
p.000017: (2) The term ‘‘health care entity’’ includes an individual physician, a postgraduate physician training
p.000017: program, and a participant in a program of training in the health professions.
p.000017: (3) The term ‘‘postgraduate physician training program’’ includes a residency training program.
p.000017: SEC. 246. ø238o¿ RESTRICTION ON USE OF FUNDS FOR ASSISTED SUI- CIDE, EUTHANASIA, AND MERCY KILLING.
p.000017: Appropriations for carrying out the purposes of this Act shall not be used in a manner inconsistent
p.000017: with the Assisted Suicide Funding Restriction Act of 1997. 20
p.000017:
p.000017: RECOMMENDATIONS AND GUIDELINES REGARDING AUTOMATED EXTERNAL DEFIBRILLATORS FOR FEDERAL BUILDINGS
p.000017: SEC. 247. ø238p¿ (a) GUIDELINES ON PLACEMENT.—The Sec-
p.000017: retary shall establish guidelines with respect to placing automated external defibrillator devices in Federal
p.000017: buildings. Such guidelines shall take into account the extent to which such devices may be used by lay
p.000017: persons, the typical number of employees and visitors in the buildings, the extent of the need for
p.000017: security measures re- garding the buildings, buildings or portions of buildings in which there are special
p.000017: circumstances such as high electrical voltage or extreme heat or cold, and such other factors as the Secretary
p.000017: deter- mines to be appropriate.
p.000017: (b) RELATED RECOMMENDATIONS.—The Secretary shall publish in the Federal Register the recommendations
p.000017: of the Secretary on the appropriate implementation of the placement of automated ex- ternal defibrillator devices
p.000017: under subsection (a), including proce- dures for the following:
p.000017: (1) Implementing appropriate training courses in the use of such devices, including the role of
p.000017: cardiopulmonary resus- citation.
p.000017: (2) Proper maintenance and testing of the devices.
p.000017: (3) Ensuring coordination with appropriate licensed profes- sionals in the oversight of training of the devices.
p.000017: (4) Ensuring coordination with local emergency medical systems regarding the placement and incidents of
p.000017: use of the devices.
p.000017: (c) CONSULTATIONS; CONSIDERATION OF CERTAIN RECOMMENDA-
p.000017: TIONS.—In carrying out this section, the Secretary shall—
p.000017: (1) consult with appropriate public and private entities;
p.000017: (2) consider the recommendations of national and local public-health organizations for improving the
p.000017: survival rates of individuals who experience cardiac arrest in nonhospital set- tings by minimizing the
p.000017: time elapsing between the onset of
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 20 Public Law 105–12 (111 Stat. 23).
p.000017:
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p.000017: otherwise provided the device to such entity for compensation without selling the de- vice to the
p.000017: entity), and the harm was caused by an employee or agent of the entity who used the device while acting within
p.000017: the scope of the employment or agency of the employee or agent.
p.000017: (c) RULES OF CONSTRUCTION.—
p.000017: (1) IN GENERAL.—The following applies with respect to this section:
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p.000017: January 30, 2020
p.000017: (A) This section does not establish any cause of action, or require that an automated external defibrillator
p.000017: device be placed at any building or other location.
p.000017: (B) With respect to a class of persons for which this section provides immunity from civil liability,
p.000017: this section supersedes the law of a State only to the extent that the State has no statute or regulations
p.000017: that provide persons in such class with immunity for civil liability arising from the use by such persons of automated
p.000017: external defibrillator de- vices in emergency situations (within the meaning of the State law or regulation
p.000017: involved).
p.000017: (C) This section does not waive any protection from li- ability for Federal officers or employees under—
p.000017: (i) section 224; or
p.000017: (ii) sections 1346(b), 2672, and 2679 of title 28, United States Code, or under alternative benefits pro- vided
p.000017: by the United States where the availability of such benefits precludes a remedy under section
p.000017: 1346(b) of title 28.
p.000017: (2) CIVIL ACTIONS UNDER FEDERAL LAW.—
p.000017: (A) IN GENERAL.—The applicability of subsections (a) and (b) includes applicability to any action for civil
p.000017: liability described in subsection (a) that arises under Federal law.
p.000017: (B) FEDERAL AREAS ADOPTING STATE LAW.—If a geo- graphic area is under Federal jurisdiction and is
p.000017: located within a State but out of the jurisdiction of the State, and if, pursuant to Federal law, the law of the State
p.000017: applies in such area regarding matters for which there is no applica- ble Federal law, then an action for civil
p.000017: liability described in subsection (a) that in such area arises under the law of the State is subject to
p.000017: subsections (a) through (c) in lieu of any related State law that would apply in such area in the absence of this
p.000017: subparagraph.
p.000017: (d) FEDERAL JURISDICTION.—In any civil action arising under State law, the courts of the State involved
p.000017: have jurisdiction to apply the provisions of this section exclusive of the jurisdiction of the courts of
p.000017: the United States.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: den- tal, and nursing personnel.
p.000017: (c) DEVELOPMENT.—The development of the Track may be by such phases as the Secretary may prescribe subject to
p.000017: the require- ments of subsection (a).
p.000017: (d) INTEGRATED LONGITUDINAL PLAN.—The Surgeon General shall develop an integrated longitudinal plan for health
p.000017: professions continuing education throughout the continuum of health-related education, training, and practice.
p.000017: Training under such plan shall emphasize patient-centered, interdisciplinary, and care coordina- tion
p.000017: skills. Experience with deployment of emergency response teams shall be included during the clinical experiences.
p.000017: (e) FACULTY DEVELOPMENT.—The Surgeon General shall de- velop faculty development programs and curricula in
p.000017: decentralized venues of health care, to balance urban, tertiary, and inpatient venues.
p.000017: SEC. 272. ø239l–1¿ ADMINISTRATION.
p.000017: (a) IN GENERAL.—The business of the Track shall be conducted by the Surgeon General with funds appropriated for
p.000017: and provided by the Department of Health and Human Services. The National Health Care Workforce Commission
p.000017: shall assist the Surgeon Gen- eral in an advisory capacity.
p.000017: (b) FACULTY.—
p.000017: (1) IN GENERAL.—The Surgeon General, after considering the recommendations of the National Health Care
p.000017: Workforce Commission, shall obtain the services of such professors, in- structors, and administrative and
p.000017: other employees as may be necessary to operate the Track, but utilize when possible, ex- isting
p.000017: affiliated health professions training institutions. Mem- bers of the faculty and staff shall be employed
p.000017: under salary schedules and granted retirement and other related benefits prescribed by the Secretary so as to
p.000017: place the employees of the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: 69 PUBLIC HEALTH SERVICE ACT Sec. 272
p.000017:
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p.000017: January 30, 2020
p.000017: Track faculty on a comparable basis with the employees of fully accredited schools of the health
p.000017: professions within the United States.
p.000017: (2) TITLES.—The Surgeon General may confer academic ti- tles, as appropriate, upon the members of the faculty.
p.000017: (3) NONAPPLICATION OF PROVISIONS.—The limitations in section 5373 of title 5, United States Code, shall
p.000017: not apply to the authority of the Surgeon General under paragraph (1) to prescribe salary schedules and
p.000017: other related benefits.
p.000017: (c) AGREEMENTS.—The Surgeon General may negotiate agree- ments with agencies of the Federal Government to utilize
p.000017: on a re- imbursable basis appropriate existing Federal medical resources lo- cated in the United States (or locations
p.000017: selected in accordance with section 271(a)(2)). Under such agreements the facilities concerned will retain
p.000017: their identities and basic missions. The Surgeon Gen- eral may negotiate affiliation agreements with
p.000017: accredited univer- sities and health professions training institutions in the United States. Such agreements
p.000017: may include provisions for payments for educational services provided students participating in Department of
p.000017: Health and Human Services educational programs.
p.000017: (d) PROGRAMS.—The Surgeon General may establish the fol- lowing educational programs for Track students:
p.000017: (1) Postdoctoral, postgraduate, and technological programs.
p.000017: (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students.
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p.000017: costs and for a health services research, evaluation, or demonstration project, or for a grant under section
p.000017: 306(m), shall be submitted to a peer re- view group for an evaluation of the technical and scientific
p.000017: merits of the proposals made in each such application. The Director of the National Center for Health Statistics
p.000017: shall establish such peer re- view groups as may be necessary to provide for such an evaluation of each such
p.000017: application.
p.000017: (B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report
p.000017: its finding and rec- ommendations respecting the application to the Secretary, acting through the Director
p.000017: of the National Center for Health Statistics, in such form and manner as the Secretary shall by regulation pre-
p.000017: scribe. The Secretary may not approve an application described in such subparagraph unless a peer review
p.000017: group has recommended the application for approval.
p.000017: (C) The Secretary, acting through the Director of the National Center for Health Statistics, shall make
p.000017: appointments to the peer review groups required in subparagraph (A) from among persons
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017: who are not officers or employees of the United States and who possess appropriate technical and
p.000017: scientific qualifications, except that peer review groups regarding grants under section 306(m) may include
p.000017: appropriately qualified such officers and employees.
p.000017: (c) The Secretary shall take such action as may be necessary to assure that statistics developed under
p.000017: sections 304 and 306 are of high quality, timely, comprehensive as well as specific, standard- ized, and adequately
p.000017: analyzed and indexed, and shall publish, make available, and disseminate such statistics on as wide a basis as is
p.000017: practicable.
p.000017: (d) No information, if an establishment or person supplying the information or described in it is identifiable,
p.000017: obtained in the course of activities undertaken or supported under section 304, 306, or 307 may be used for any
p.000017: purpose other than the purpose for which it was supplied unless such establishment or person has
p.000017: consented (as determined under regulations of the Secretary) to its use for such other purpose and in
p.000017: the case of information obtained in the course of health statistical or epidemiological activities under
p.000017: sec- tion 304 or 306, such information may not be published or released in other form if the particular
p.000017: establishment or person supplying the information or described in it is identifiable unless such estab- lishment or
p.000017: person has consented (as determined under regulations of the Secretary) to its publication or release in other form.
p.000017: (e)(1) Payments of any grant or under any contract under sec- tion 304, 306, or 307 may be made in advance or
p.000017: by way of reim- bursement, and in such installments and on such conditions, as the Secretary deems necessary to
p.000017: carry out the purposes of such sec- tion.
p.000017: (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307
p.000017: shall be re- duced by—
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p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
p.000017: (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the
p.000017: manufac- turers of the devices;
p.000017: (4) by providing training to members of the public in cardiopulmonary resuscitation and automated
p.000017: external defibrillation;
p.000017: (5) by integrating the emergency medical services system with the public access defibrillation programs so
p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
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p.000117: (3) Demonstration projects for—
p.000117: (A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent
p.000117: multidrug resistant and extensively drug resistant strains of tuber- culosis;
p.000117: (B) the intensification of efforts to reduce health dis- parities in the incidence of tuberculosis;
p.000117: (C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among
p.000117: United States-Mexico binational populations, including through expansion of the scope and number of programs
p.000117: that—
p.000117: (i) detect and treat binational cases of tuber- culosis; and
p.000117: (ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
p.000117: (D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are
p.000117: in the United States;
p.000117: (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings
p.000117: docu- mented as having a high risk for tuberculosis; and
p.000117: (F) tuberculosis detection, control, and prevention.
p.000117: (4) Public information and education activities.
p.000117: (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention
p.000117: for health profes- sionals, including allied health personnel and emergency re- sponse employees.
p.000117: (6) Support of Centers to carry out activities under para- graphs (1) through (4).
p.000117: (7) Collaboration with international organizations and for- eign countries in carrying out such activities.
p.000117: (8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance
p.000117: and database management systems with cross-jurisdictional capa- bilities, which shall conform to the standards
p.000117: and implementa- tion specifications for such information technologies as rec- ommended by the Secretary.
p.000117: (c) COOPERATION WITH PROVIDERS OF PRIMARY HEALTH SERV- ICES.—The Secretary may make a grant under subsection (a)
p.000117: or (b) only if the applicant for the grant agrees that, in carrying out ac- tivities under the grant,
p.000117: the applicant will cooperate with public and nonprofit private providers of primary health services or
p.000117: sub- stance abuse services, including entities receiving assistance under section 329, 330, or 340A or under title V or
p.000117: XIX.
p.000117: (d) APPLICATION FOR GRANT.—
p.000117: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) or (b) only if an application for the grant
p.000117: is sub-
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000119: PUBLIC HEALTH SERVICE ACT
p.000119: Sec. 317E
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p.000119: Sec. 317E PUBLIC HEALTH SERVICE ACT 120
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p.000119:
p.000119: (B) responding rapidly and effectively to emerging issues in tuberculosis; and
p.000119: (C) efficiently utilizing the Federal resources involved.
p.000119: (3) COMPREHENSIVE PLAN.—
p.000119: (A) IN GENERAL.—In carrying out paragraph (2), the Council shall make or update recommendations on the de-
p.000119: velopment, revision, and implementation of a comprehen- sive plan to eliminate tuberculosis in the United States.
p.000119: (B) CONSULTATION.—In carrying out subparagraph (A), the Council may consult with appropriate public and
p.000119: private entities, which may, subject to the direction or dis- cretion of the Secretary, include—
p.000119: (i) individuals who are scientists, physicians, laboratorians, and other health professionals, who are not
p.000119: officers or employees of the Federal Government and who represent the disciplines relevant to tuber-
p.000119: culosis elimination;
p.000119: (ii) members of public-private partnerships or pri- vate entities established to address the elimination of
p.000119: tuberculosis;
p.000119: (iii) members of national and international non- governmental organizations whose purpose is to elimi- nate
p.000119: tuberculosis;
p.000119: (iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including
p.000119: individuals who have or have had tuber- culosis; and
p.000119: (v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country
p.000119: with a substantial incidence or prevalence of tuber- culosis, and who represent the specialties and dis-
p.000119: ciplines relevant to the research under consideration.
p.000119: (C) CERTAIN COMPONENTS OF PLAN.—In carrying out subparagraph (A), the Council shall, subject to the
p.000119: direc- tion or discretion of the Secretary—
p.000119: (i) consider recommendations for the involvement of the United States in continuing global and cross-
p.000119: border tuberculosis control activities in countries where a high incidence of tuberculosis directly
p.000119: affects the United States; and
p.000119: (ii) review the extent to which progress has been made toward eliminating tuberculosis.
p.000119: (4) BIENNIAL REPORT.—
p.000119: (A) IN GENERAL.—The Council shall submit a biennial report to the Secretary, as determined necessary by the
p.000119: Secretary, on the activities carried under this section. Each such report shall include the opinion
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p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
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p.000121: January 30, 2020
p.000121: LOAN REPAYMENT PROGRAM
p.000121: SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
p.000121: (1) AUTHORITY.—Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with
p.000121: appro- priately qualified health professionals under which such health professionals agree to conduct prevention
p.000121: activities or pre- paredness and response activities, including rapid response to public health
p.000121: emergencies and significant public health threats, as employees of the Centers for Disease Control
p.000121: and Prevention and the Agency for Toxic Substances and Disease
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000121:
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p.000123: PUBLIC HEALTH SERVICE ACT
p.000123: Sec. 317H
p.000123:
p.000123: Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than
p.000123: $50,000 of the principal and interest of the educational loans of such health professionals.
p.000123: (2) LIMITATION.—The Secretary may not enter into an agreement with a health professional pursuant to
p.000123: paragraph
p.000123: (1) unless such professional—
p.000123: (A) has a substantial amount of educational loans rel- ative to income; and
p.000123: (B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for
p.000123: Toxic Substances and Disease Registry for purposes of para- graph (1) for a period of not less than 2 years.
p.000123: (b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to the National Health Service Corps Loan
p.000123: Repayment Program es- tablished in subpart III of part D of title III of this Act, the provi- sions of such
p.000123: subpart shall, except as inconsistent with subsection (a), apply to the program established in this
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p.000185: PUBLIC HEALTH SERVICE ACT
p.000185: Sec. 319D
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p.000185: (F) promote greater coordination among existing Fed- eral interagency telemedicine and health information tech-
p.000185: nology initiatives.
p.000185: (2) REPORT.—Not later than 12 months after the date of enactment of the Pandemic and All-Hazards Preparedness
p.000185: Act, the Secretary shall prepare and submit a report to the Com- mittee on Health, Education, Labor, and
p.000185: Pensions of the Sen- ate and the Committee on Energy and Commerce of the House of Representatives regarding the
p.000185: findings and recommenda- tions pursuant to subparagraphs (A) through (F) of paragraph (1).
p.000185: (f) PERSONNEL AUTHORITIES.—
p.000185: (1) SPECIALLY QUALIFIED PERSONNEL.—In addition to any other personnel authorities, to carry out subsections (b)
p.000185: and (c), the Secretary may—
p.000185: (A) appoint highly qualified individuals to scientific or professional positions at the Centers for Disease
p.000185: Control and Prevention, not to exceed 30 such employees at any time (specific to positions authorized by
p.000185: this subsection), with expertise in capabilities relevant to biosurveillance and situational awareness, such
p.000185: as experts in informatics and data analytics (including experts in prediction, mod- eling, or forecasting),
p.000185: and other related scientific or tech- nical fields; and
p.000185: (B) compensate individuals appointed under subpara- graph (A) in the same manner and subject to the same
p.000185: terms and conditions in which individuals appointed under 9903 of title 5, United States Code, are compensated, with-
p.000185: out regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to
p.000185: classification and General Schedule pay rates.
p.000185: (2) LIMITATIONS.—The Secretary shall exercise the author- ity under paragraph (1) in a manner that is consistent with
p.000185: the limitations described in section 319F–1(e)(2).
p.000185: (g) TIMELINE.—The Secretary shall accomplish the purposes under subsections (b) and (c) no later than
p.000185: September 30, 2023, and shall provide a justification to the congressional committees of jurisdiction for any
p.000185: missed or delayed implementation of measur- able steps identified under subsection (c)(6)(A)(iii).
p.000185: (h) INDEPENDENT EVALUATION.—Not later than 3 years after the date of enactment of the Pandemic and
p.000185: All-Hazards Prepared- ness and Advancing Innovation Act of 2019, the Comptroller Gen- eral of the United
p.000185: States shall conduct an independent evaluation and submit to the Secretary and the congressional
p.000185: committees of jurisdiction a report concerning the activities conducted under sub- sections (b) and (c), and
...

p.000199: or is not deemed to be an employee of the Department of Health and Human Services shall be final and
p.000199: binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.
p.000199: (4) NUMBER OF PERSONAL SERVICES CONTRACTS LIMITED.— The number of experts and consultants whose personal
p.000199: serv- ices are obtained under paragraph (1) shall not exceed 30 at any time.
p.000199: (e) STREAMLINED PERSONNEL AUTHORITY.—
p.000199: (1) IN GENERAL.—In addition to any other personnel au- thorities, the Secretary may, as the Secretary
p.000199: determines nec- essary to respond to pressing qualified countermeasure re- search and development needs
p.000199: under this section, without re- gard to those provisions of title 5, United States Code, gov- erning
p.000199: appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000199: subchapter III of
p.000199: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000199:
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p.000201: PUBLIC HEALTH SERVICE ACT
p.000201: Sec. 319F–2
p.000201:
p.000201: chapter 53 of such title relating to classification and General Schedule pay rates, appoint professional and
p.000201: technical employ- ees, not to exceed 30 such employees at any time, to positions in the National Institutes of Health
p.000201: to perform, administer, or support qualified countermeasure research and development activities in carrying out
p.000201: this section.
p.000201: (2) LIMITATIONS.—The authority provided for under para- graph (1) shall be exercised in a manner that—
p.000201: (A) recruits and appoints individuals based solely on their abilities, knowledge, and skills;
p.000201: (B) does not discriminate for or against any applicant for employment on any basis described
p.000201: in section 2302(b)(1) of title 5, United States Code;
p.000201: (C) does not allow an official to appoint an individual who is a relative (as defined in section
p.000201: 3110(a)(3) of such title) of such official;
p.000201: (D) does not discriminate for or against an individual because of the exercise of any activity described
p.000201: in para- graph (9) or (10) of section 2302(b) of such title; and
p.000201: (E) accords a preference, among equally qualified per- sons, to persons who are preference eligibles (as defined in
p.000201: section 2108(3) of such title).
p.000201: (3) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for
p.000201: appointments under this subsection.
p.000201: (f) ACTIONS COMMITTED TO AGENCY DISCRETION.—Actions by the Secretary under the authority of this section are
p.000201: committed to agency discretion.
p.000201: SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECU-
p.000201: RITY COUNTERMEASURE PROCUREMENTS. 22
p.000201: (a) STRATEGIC NATIONAL STOCKPILE.—
p.000201: (1) IN GENERAL.—The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and
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p.000225: the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the
p.000225: reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that
p.000225: is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter
p.000225: repetition of such conduct or comparable conduct by others similarly situated, and to compensate the
p.000225: party or parties injured by such conduct.
p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
p.000225: right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law
p.000225: or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United
p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
p.000225: section, or any amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed
p.000225: to affect the National Vaccine In- jury Compensation Program under title XXI of this Act.
p.000225: (i) DEFINITIONS.—In this section:
p.000225: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means—
p.000225: (A) a qualified pandemic or epidemic product (as de- fined in paragraph (7));
p.000225: (B) a security countermeasure (as defined in section 319F–2(c)(1)(B)); or
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000227: PUBLIC HEALTH SERVICE ACT
p.000227: Sec. 319F–3
p.000227:
p.000227: (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21
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p.000235: (2) IN GENERAL.—Based upon the strategic plan described in subsection (b), the Secretary shall coordinate
p.000235: the accelera- tion of countermeasure and product advanced research and de- velopment by—
p.000235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000237: Sec. 319L
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p.000237: January 30, 2020
p.000237: (A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies,
p.000237: relevant industries, academia, and other persons, with re- spect to such advanced research and development;
p.000237: (B) promoting countermeasure and product advanced research and development;
p.000237: (C) facilitating contacts between interested persons and the offices or employees authorized by the
p.000237: Secretary to advise such persons regarding requirements under the Federal Food, Drug, and Cosmetic Act and
p.000237: under section 351 of this Act; and
p.000237: (D) promoting innovation to reduce the time and cost of countermeasure and product advanced research and de-
p.000237: velopment.
p.000237: (3) DIRECTOR.—The BARDA shall be headed by a Director (referred to in this section as the ‘‘Director’’) who
p.000237: shall be ap- pointed by the Secretary and to whom the Secretary shall dele- gate such functions and authorities as
p.000237: necessary to implement this section, including the execution of procurement contracts, grants, and cooperative
p.000237: agreements pursuant to this section.
p.000237: (4) DUTIES.—
p.000237: (A) COLLABORATION.—To carry out the purpose de- scribed in paragraph (2)(A), the Secretary shall—
p.000237: (i) facilitate and increase the expeditious and di- rect communication between the Department of
p.000237: Health and Human Services and relevant persons with respect to countermeasure and product advanced research
p.000237: and development, including by—
p.000237: (I) facilitating such communication regarding the processes for procuring such advanced re- search and
p.000237: development with respect to qualified countermeasures and qualified pandemic or epi- demic products of
p.000237: interest; and
p.000237: (II) soliciting information about and data from research on potential qualified countermeasures and qualified
p.000237: pandemic or epidemic products and related technologies;
p.000237: (ii) at least annually—
p.000237: (I) convene meetings with representatives from relevant industries, academia, other Federal agencies,
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p.000237: January 30, 2020
p.000237:
p.000237: (i) conduct ongoing searches for, and support calls for, potential qualified countermeasures and qualified
p.000237: pandemic or epidemic products;
p.000237: (ii) direct and coordinate the countermeasure and product advanced research and development activities of
p.000237: the Department of Health and Human Services;
p.000237: (iii) establish strategic initiatives to accelerate countermeasure and product advanced research and
p.000237: development (which may include advanced research and development for purposes of fulfilling require-
p.000237: ments under the Federal Food, Drug, and Cosmetic Act or section 351 of this Act) and innovation in such areas as
p.000237: the Secretary may identify as priority unmet need areas; and
p.000237: (iv) award contracts, grants, cooperative agree- ments, and enter into other transactions, for counter-
p.000237: measure and product advanced research and develop- ment.
p.000237: (C) FACILITATING ADVICE.—To carry out the purpose described in paragraph (2)(C) the Secretary shall—
p.000237: (i) connect interested persons with the offices or employees authorized by the Secretary to advise such
p.000237: persons regarding the regulatory requirements under the Federal Food, Drug, and Cosmetic Act and under
p.000237: section 351 of this Act related to the approval, clear- ance, or licensure of qualified
p.000237: countermeasures or qualified pandemic or epidemic products; and
p.000237: (ii) with respect to persons performing counter- measure and product advanced research and develop- ment
p.000237: funded under this section, enable such offices or employees to provide to the extent practicable such ad- vice in a
p.000237: manner that is ongoing and that is otherwise designed to facilitate expeditious development of quali- fied
p.000237: countermeasures and qualified pandemic or epi- demic products that may achieve such approval, clear- ance, or
p.000237: licensure.
p.000237: (D) SUPPORTING INNOVATION.—To carry out the pur- pose described in paragraph (2)(D), the Secretary may
p.000237: award contracts, grants, and cooperative agreements, or enter into other transactions, such as prize
p.000237: payments, to promote—
p.000237: (i) innovation in technologies that may assist countermeasure and product advanced research and
p.000237: development;
p.000237: (ii) research on and development of research tools and other devices and technologies; and
p.000237: (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials,
p.000237: vaccine-manufacturing technologies, dose-sparing tech- nologies, efficacy-increasing technologies, platform
p.000237: technologies, technologies to administer counter- measures, and technologies to improve storage and
p.000237: transportation of countermeasures.
p.000237: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000239: PUBLIC HEALTH SERVICE ACT
p.000239: Sec. 319L
p.000239:
p.000239: (E) MEDICAL COUNTERMEASURES INNOVATION PART- NER.—
p.000239: (i) IN GENERAL.—To support the purposes de- scribed in paragraph (2), the Secretary, acting through the
...

p.000243: (i) IN GENERAL.—In addition to any other per- sonnel authorities, the Secretary may—
p.000243: (I) without regard to those provisions of title 5, United States Code, governing appointments in the
p.000243: competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such
p.000243: as program managers, to carry out this section; and
p.000243: (II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed
p.000243: under section 9903 of such title are compensated, without regard to the provi- sions of chapter 51 and
p.000243: subchapter III of chapter 53 of such title relating to classification and Gen- eral Schedule pay rates.
p.000243: (ii) MANNER OF EXERCISE OF AUTHORITY.—The au- thority provided for in this subparagraph shall be ex-
p.000243: ercised subject to the same limitations described in section 319F–1(e)(2).
p.000243: (iii) TERM OF APPOINTMENT.—The term limitations described in section 9903(c) of title 5, United States Code,
p.000243: shall apply to appointments under this subpara- graph, except that the references to the ‘‘Secretary’’ and to
p.000243: the ‘‘Department of Defense’s national security missions’’ shall be deemed to be to the Secretary of Health
p.000243: and Human Services and to the mission of the Department of Health and Human Services under this section.
p.000243: (B) SPECIAL CONSULTANTS.—In carrying out this sec- tion, the Secretary may appoint special consultants pursu-
p.000243: ant to section 207(f).
p.000243: (C) LIMITATION.—
p.000243: (i) IN GENERAL.—The Secretary may hire up to 100 highly qualified individuals, or up to 50 percent of the
p.000243: total number of employees, whichever is less, under the authorities provided for in subparagraphs
p.000243: (A) and (B).
p.000243: (ii) REPORT.—The Secretary shall report to Con- gress on a biennial basis on the implementation of this
p.000243: subparagraph.
p.000243: (d) FUND.—
p.000243: (1) ESTABLISHMENT.—There is established the Biodefense Medical Countermeasure Development Fund, which shall
p.000243: be available to carry out this section in addition to such amounts as are otherwise available for this purpose.
p.000243: (2) FUNDING.—To carry out the purposes of this section, there is authorized to be appropriated
p.000243: to the Fund
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000245: PUBLIC HEALTH SERVICE ACT
p.000245: Sec. 319L
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p.000245: January 30, 2020
p.000245: $611,700,000 for each of fiscal years 2019 through 2023, such amounts to remain available until expended.
...

p.000251: naturally occur- ring infectious diseases and chemical, biological, radio- logical, and nuclear agents;
p.000251: (B) at the request of the Secretary, review and con- sider any information and findings received from the
p.000251: work- ing groups established under subsection (b);
p.000251: (C) at the request of the Secretary, provide rec- ommendations and findings for expanded,
p.000251: intensified, and coordinated biodefense research and development activi- ties; and
p.000251: (D) provide any recommendation, finding, or report provided to the Secretary under this paragraph to the ap-
p.000251: propriate committees of Congress.
p.000251: (6) MEETINGS.—
p.000251: (A) INITIAL MEETING.—Not later than one year after the date of enactment of the Pandemic and
p.000251: All-Hazards Preparedness Act, the Secretary shall hold the first meet- ing of the Board.
p.000251: (B) SUBSEQUENT MEETINGS.—The Board shall meet at the call of the Secretary, but in no case less than twice an-
p.000251: nually.
p.000251: (7) VACANCIES.—Any vacancy in the Board shall not affect its powers, but shall be filled in the same manner as the
p.000251: origi- nal appointment.
p.000251: (8) CHAIRPERSON.—The Secretary shall appoint a chair- person from among the members of the Board.
p.000251: (9) POWERS.—
p.000251: (A) HEARINGS.—The Board may hold such hearings, sit and act at such times and places, take such testimony, and
p.000251: receive such evidence as the Board considers advisable to carry out this subsection.
p.000251: (B) POSTAL SERVICES.—The Board may use the United States mails in the same manner and under the same con- ditions as
p.000251: other departments and agencies of the Federal Government.
p.000251: (10) PERSONNEL.—
p.000251: (A) EMPLOYEES OF THE FEDERAL GOVERNMENT.—A member of the Board that is an employee of the
p.000251: Federal Government may not receive additional pay, allowances, or benefits by reason of the member’s service on
p.000251: the Board.
p.000251: (B) OTHER MEMBERS.—A member of the Board that is not an employee of the Federal Government may be com-
p.000251: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000251: Sec. 320 PUBLIC HEALTH SERVICE ACT 252
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p.000251: January 30, 2020
p.000251:
p.000251: pensated at a rate not to exceed the daily equivalent of the annual rate of basic pay prescribed for level IV of the
p.000251: Ex- ecutive Schedule under section 5315 of title 5, United States Code, for each day (including travel
p.000251: time) during which the member is engaged in the actual performance of duties as a member of the Board.
p.000251: (C) TRAVEL EXPENSES.—Each member of the Board shall receive travel expenses, including per diem in lieu of
p.000251: subsistence, in accordance with applicable provisions under subchapter I of chapter 57 of title 5,
p.000251: United States Code.
p.000251: (D) DETAIL OF GOVERNMENT EMPLOYEES.—Any Federal Government employee may be detailed to the Board with the
p.000251: approval for the contributing agency without reim- bursement, and such detail shall be without
p.000251: interruption or loss of civil service status or privilege.
p.000251: (b) OTHER WORKING GROUPS.—The Secretary may establish a working group of experts, or may use an existing working
p.000251: group or advisory committee, to—
p.000251: (1) identify innovative research with the potential to be de- veloped as a qualified countermeasure or a qualified
p.000251: pandemic or epidemic product;
p.000251: (2) identify accepted animal models for particular diseases and conditions associated with any biological,
p.000251: chemical, radio- logical, or nuclear agent, any toxin, or any potential pandemic infectious disease, and identify
p.000251: strategies to accelerate animal model and research tool development and validation; and
p.000251: (3) obtain advice regarding supporting and facilitating ad- vanced research and development related to qualified
p.000251: counter- measures and qualified pandemic or epidemic products that are likely to be safe and effective
p.000251: with respect to children, pregnant women, and other vulnerable populations, and other issues regarding
p.000251: activities under this section that affect such populations.
p.000251: (c) DEFINITIONS.—Any term that is defined in section 319L and that is used in this section shall have the same
p.000251: meaning in this section as such term is given in section 319L.
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p.000253: by the Public Health Service.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000255: 255
p.000255: PUBLIC HEALTH SERVICE ACT
p.000255: Sec. 324
p.000255:
p.000255: (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in
p.000255: accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in
p.000255: case of emergency.
p.000255: (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with
p.000255: regulations, receive such care and treatment at the expense of the Service from public or private medical or
p.000255: hospital facilities other than those of the Service, when authorized by the officer in charge of the station
p.000255: at which the ap- plication is made.
p.000255: CARE AND TREATMENT OF FEDERAL PRISONERS 27
p.000255: SEC. 323. ø250¿ The Service shall supervise and furnish med- ical treatment and other necessary medical,
p.000255: psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended
p.000255: (U.S.C., 1940 edition, title 18, secs. 751, 752), 28 in penal and correctional institutions of the United
p.000255: States.
p.000255: EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES
p.000255: SEC. 324. ø251¿ (a) The Surgeon General is authorized to pro- vide at institutions, hospitals, and stations of
p.000255: the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under
p.000255: the United States Employees’ Compensation Act 29 and extensions thereof. The Surgeon General may also provide
p.000255: for making medical examinations of—
p.000255: (1) employees of the Federal Government for retirement purposes;
p.000255: (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service
p.000255: Commission for the purpose of promoting health and efficiency;
p.000255: (3) seamen for purposes of qualifying for certificates of service; and
p.000255: (4) employees eligible for benefits under the Longshore- men’s and Harbor Workers’ Compensation Act, as
p.000255: amended (U.S.C. 1940 edition, title 33, chapter 18), 30 as requested by any deputy commissioner thereunder.
p.000255: (b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and
p.000255: optometric care for Federal employees (as defined in section 8901(1) of title 5 of the United States
p.000255: Code) and their dependents at remote medical facili- ties of the Public Health Service where such care and
p.000255: treatment are not otherwise available. Such employees and their dependents who are not entitled to this
p.000255: care and treatment under any other provision of law shall be charged for it at rates established by the
p.000255:
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p.000255: January 30, 2020
p.000255: 27 Title I of the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies
p.000255: Appropriations Act, 2005 (as contained in division B of Public Law 108–447) provided that of the amounts appropriated
p.000255: for salaries and expenses regarding the Federal Prison System ‘‘the Attorney General may transfer to the Health
p.000255: Resources and Services Administration such amounts as may be necessary for direct expenditures by that
p.000255: Administration for medical relief for inmates of Federal penal and correctional institutions’’. (See 118 Stat.
p.000255: 2860.) Similar provi- sions have appeared in the analogous appropriations Act of many prior years. See section 250a of
p.000255: title 42, United States Code, and the notes following such section.
p.000255: 28 Now codified to section 4005 of title 18, United States Code.
p.000255: 29 Codified to chapter 81 of title 5, United States Code.
p.000255: 30 Codification remains chapter 18 of title 33, United States Code.
p.000255: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000255:
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p.000255: Sec. 325 PUBLIC HEALTH SERVICE ACT 256
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p.000301: (e) ACCESS TO BROADBAND.—In administering grants under this section, the Secretary may coordinate with
p.000301: other agencies to ensure that funding opportunities are available to support access to reliable, high-speed
p.000301: Internet for providers.
p.000301: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section unless the State, political
p.000301: subdivision of a State, Indian tribe, or tribal organization involved agrees, with re- spect to the costs to be
p.000301: incurred by the State, political subdivision of a State, Indian tribe, or tribal organization in carrying out
p.000301: the purpose described in this section, to make available non-Federal contributions (in cash or in kind)
p.000301: toward such costs in an amount that is not less than 20 percent of Federal funds provided in the
p.000301: grant.
p.000301: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated, $9,000,000
p.000301: for the pe- riod of fiscal years 2018 through 2022.
p.000301: Subpart II—National Health Service Corps Program
p.000301: NATIONAL HEALTH SERVICE CORPS
p.000301: SEC. 331. ø254d¿ (a)(1) For the purpose of eliminating health manpower 38 shortages in health professional
p.000301: shortage areas, there is established, within the Service, the National Health Service Corps, which shall
p.000301: consist of—
p.000301: (A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
p.000301: (B) such civilian employees of the United States as the Secretary may appoint, and
p.000301: (C) such other individuals who are not employees of the United States.
p.000301: (2) The Corps shall be utilized by the Secretary to provide pri- mary health services in health professional shortage
p.000301: areas.
p.000301: (3) For purposes of this subpart and subpart III:
p.000301: (A) The term ‘‘Corps’’ means the National Health Service Corps.
p.000301: (B) The term ‘‘Corps member’’ means each of the officers, employees, and individuals of which the Corps
p.000301: consists pursu- ant to paragraph (1).
p.000301: (C) The term ‘‘health professional shortage area’’ has the meaning given such term in section 332(a).
p.000301: (D) The term ‘‘primary health services’’ means health serv- ices regarding family medicine, internal medicine,
p.000301: pediatrics, obstetrics and gynecology, dentistry, or mental health, that are provided by physicians or other health
p.000301: professionals.
p.000301: (E)(i) The term ‘‘behavioral and mental health profes- sionals’’ means health service psychologists,
p.000301: licensed clinical social workers, licensed professional counselors, marriage and family therapists,
p.000301: psychiatric nurse specialists, and psychia- trists.
p.000301:
p.000301:
p.000301:
p.000301:
p.000301: January 30, 2020
p.000301: 38 So in law. Probably should be ‘‘health professional shortages’’. See section 401 of Public Law 101–597 (104 Stat.
p.000301: 3035).
p.000301: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000303: PUBLIC HEALTH SERVICE ACT
p.000303: Sec. 331
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p.000305: accessible to an adequately served area;
p.000305: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000307: PUBLIC HEALTH SERVICE ACT
p.000307: Sec. 332
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p.000307: (B) such a facility of a State correctional institution or of the Indian Health Service, and a health program
p.000307: or facility op- erated by a tribe or tribal organization under the Indian Self- Determination Act;
p.000307: (C) such a facility used in connection with the delivery of health services under section 321 (relating
p.000307: to hospitals), 322 (relating to care and treatment of persons under quarantine and others), 323 (relating
p.000307: to care and treatment of Federal prisoners), 324 (relating to examination and treatment of cer- tain
p.000307: Federal employees), 325 (relating to examination of aliens), 326 (relating to services to certain Federal
p.000307: employees), 320 (relating to services for persons with Hansen’s disease), or 330(h) (relating to the provision of
p.000307: health services to homeless individuals); and
p.000307: (D) a Federal medical facility.
p.000307: (3) Homeless individuals (as defined in section 330(h)(5)), sea- sonal agricultural workers (as defined in
p.000307: section 330(g)(3)) and mi- gratory agricultural workers (as so defined)), and residents of pub- lic housing (as defined
p.000307: in section 3(b)(1) of the United States Hous- ing Act of 1937 (42 U.S.C. 1437a(b)(1))) may be population
p.000307: groups under paragraph (1).
p.000307: (b) The Secretary shall establish by regulation criteria for the designation of areas, population
p.000307: groups, medical facilities, and other public facilities, in the States, as health professional shortage areas.
p.000307: In establishing such criteria, the Secretary shall take into consideration the following:
p.000307: (1) The ratio of available health manpower to the number of individuals in an area or population group, or
p.000307: served by a medical facility or other public facility under consideration for designation.
p.000307: (2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the
p.000307: individuals in an area or population group or served by a medical facility or other public facility under
p.000307: consideration for designation.
p.000307: (3) The percentage of physicians serving an area, popu- lation group, medical facility, or other public
p.000307: facility under con- sideration for designation who are employed by hospitals and who are graduates of foreign
p.000307: medical schools.
...

p.000321: continue to provide health services in health professional shortage areas after termination of their service in
p.000321: the Corps and the reasons (as reported to the Secretary) of members who did not elect for not making such election;
p.000321: (7) the results of evaluations and determinations made under section 333(a)(1)(D) during such year; and
p.000321: (8) the amount charged during such year for health serv- ices provided by Corps members, the amount
p.000321: which was col- lected in such year by entities in accordance with section 334, and the amount which was paid to the
p.000321: Secretary in such year under such agreements 42.
p.000321: NATIONAL ADVISORY COUNCIL
p.000321: SEC. 337. ø254j¿ (a) There is established a council to be known as the National Advisory Council on the National
p.000321: Health Service Corps (hereinafter in this section referred to as the ‘‘Council’’). The Council shall be composed of
p.000321: fifteen members appointed by the Sec- retary. The Council shall consult with, advise, and make rec-
p.000321: ommendations to, the Secretary with respect to his responsibilities in carrying out this subpart (other than
p.000321: section 338G), and shall review and comment upon regulations promulgated by the Sec- retary under this
p.000321: subpart.
p.000321: (b)(1) Members of the Council shall be appointed for a term of three years, except that any member appointed to fill a
p.000321: vacancy oc- curring prior to the expiration of the term for which the member’s predecessor was appointed shall be
p.000321: appointed for the remainder of such term. No member shall be removed, except for cause.
p.000321: (2) Members of the Council (other than members who are offi- cers or employees of the United States), while
p.000321: attending meetings or conferences thereof or otherwise serving on the business of the Council, shall be
p.000321: entitled to receive for each day (including travel- time) in which they are so serving compensation at a rate fixed by
p.000321:
p.000321:
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p.000321:
p.000321:
p.000321: January 30, 2020
p.000321: 42 There is no antecedent reference to ‘‘agreements’’. Formerly, paragraph (8) contained the clause ‘‘, the
p.000321: amount which was collected in such year by entities in accordance with agreements under section 334,’’. Section 307(b)
p.000321: of Public Law 107–251 (116 Stat. 1649) struck ‘‘agreements under’’ in that clause.
p.000321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000321:
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p.000321:
p.000321: Sec. 338 PUBLIC HEALTH SERVICE ACT 322
p.000321:
p.000321: the Secretary (but not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS–18
p.000321: of the General Sched- ule); and while so serving away from their homes or regular places of business all members
p.000321: may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of
p.000321: title 5 of the United States Code for persons in the Government service employed intermittently.
p.000321: (c) Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council.
p.000321: AUTHORIZATION OF APPROPRIATION
...

p.000393: under subsection (k), such applicant shall provide to the persons described in clause (ii), subject to the
p.000393: terms of this paragraph, confidential access to the in- formation required to be produced pursuant to
p.000393: para- graph (2) and any other information that the sub- section (k) applicant determines, in its sole
p.000393: discretion, to be appropriate (referred to in this subsection as the ‘‘confidential information’’).
p.000393: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000395: 395
p.000395: PUBLIC HEALTH SERVICE ACT
p.000395: Sec. 351
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p.000395: January 30, 2020
p.000395: (ii) RECIPIENTS OF INFORMATION.—The persons de- scribed in this clause are the following:
p.000395: (I) OUTSIDE COUNSEL.—One or more attorneys designated by the reference product sponsor who are employees of an
p.000395: entity other than the ref- erence product sponsor (referred to in this para- graph as the ‘‘outside
p.000395: counsel’’), provided that such attorneys do not engage, formally or infor- mally, in patent prosecution
p.000395: relevant or related to the reference product.
p.000395: (II) IN-HOUSE COUNSEL.—One attorney that represents the reference product sponsor who is an employee of the
p.000395: reference product sponsor, pro- vided that such attorney does not engage, formally or informally, in patent prosecution
p.000395: relevant or re- lated to the reference product.
p.000395: (iii) PATENT OWNER ACCESS.—A representative of the owner of a patent exclusively licensed to a ref-
p.000395: erence product sponsor with respect to the reference product and who has retained a right to assert the
p.000395: patent or participate in litigation concerning the pat- ent may be provided the confidential information, pro-
p.000395: vided that the representative informs the reference product sponsor and the subsection (k) applicant of his or
p.000395: her agreement to be subject to the confidentiality provisions set forth in this paragraph, including those under
p.000395: clause (ii).
p.000395: (C) LIMITATION ON DISCLOSURE.—No person that re- ceives confidential information pursuant to subparagraph
p.000395: (B) shall disclose any confidential information to any other person or entity, including the reference product
p.000395: sponsor employees, outside scientific consultants, or other outside counsel retained by the reference product
p.000395: sponsor, without the prior written consent of the subsection (k) applicant, which shall not be unreasonably
p.000395: withheld.
p.000395: (D) USE OF CONFIDENTIAL INFORMATION.—Confidential information shall be used for the sole and exclusive pur-
p.000395: pose of determining, with respect to each patent assigned to or exclusively licensed by the reference product
p.000395: sponsor, whether a claim of patent infringement could reasonably be asserted if the subsection (k)
p.000395: applicant engaged in the manufacture, use, offering for sale, sale, or importation into the United States of
p.000395: the biological product that is the subject of the application under subsection (k).
p.000395: (E) OWNERSHIP OF CONFIDENTIAL INFORMATION.—The confidential information disclosed under this paragraph is, and
p.000395: shall remain, the property of the subsection (k) appli- cant. By providing the confidential information pursuant
p.000395: to this paragraph, the subsection (k) applicant does not provide the reference product sponsor or the outside
p.000395: coun- sel any interest in or license to use the confidential infor- mation, for purposes other than those
p.000395: specified in subpara- graph (D).
p.000395: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000395:
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p.000435: January 30, 2020
p.000435: the Secretary may develop.
p.000435: (2) DATE.—The information to be compiled under para- graph (1) shall be information for the calendar
p.000435: year preceding the date the information is to be made available to the public.
p.000435: (3) EXPLANATORY INFORMATION.—The information to be compiled under paragraph (1) shall be accompanied by such
p.000435: ex- planatory information as may be appropriate to assist in the interpretation of the information
p.000435: compiled under such para- graph.
p.000435: (m) STATE LAWS.—Nothing in this section shall be construed to limit the authority of any State to enact and enforce
p.000435: laws relating to the matters covered by this section that are at least as stringent as this section or the regulations
p.000435: issued under this section.
p.000435: (n) NATIONAL ADVISORY COMMITTEE.—
p.000435: (1) ESTABLISHMENT.—In carrying out this section, the Sec- retary shall establish an advisory committee to be
p.000435: known as the National Mammography Quality Assurance Advisory Com- mittee (hereafter in this subsection referred to as
p.000435: the ‘‘Advisory Committee’’).
p.000435: (2) COMPOSITION.—The Advisory Committee shall be com- posed of not fewer than 13, nor more than 19 individuals,
p.000435: who are not officers or employees of the Federal Government. The Secretary shall make appointments to the
p.000435: Advisory Committee from among—
p.000435: (A) physicians,
p.000435: (B) practitioners, and
p.000435: (C) other health professionals,
p.000435: whose clinical practice, research specialization, or professional expertise include a significant focus on
p.000435: mammography. The Secretary shall appoint at least 4 individuals from among na- tional breast cancer or
p.000435: consumer health organizations with ex- pertise in mammography, at least 2 industry representatives with
p.000435: expertise in mammography equipment, and at least 2 practicing physicians who provide mammography services.
p.000435: (3) FUNCTIONS AND DUTIES.—The Advisory Committee shall—
p.000435: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000437: 437
p.000437: PUBLIC HEALTH SERVICE ACT
p.000437: Sec. 354
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p.000437: January 30, 2020
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p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
p.000441: darkness. No vessel shall be required to undergo quar- antine inspection during the hours of darkness,
p.000441: unless the quar- antine officer at such quarantine station shall deem an immediate inspection necessary to protect
p.000441: the public health. Uniformity shall not be required in the hours during which quarantine inspection may
p.000441: be obtained at the various ports of the United States.
p.000441: (c) The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of
p.000441: employees of the United States Public Health Service, Foreign Quarantine Division, per- forming overtime
p.000441: duties including the operation of vessels, in con- nection with the inspection or quarantine treatment of
p.000441: persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or
p.000441: any place subject to the juris- diction thereof, hereinafter referred to as ‘‘employees of the Public Health
p.000441: Service’’, when required to be on duty between the hours of 6 o’clock postmeridian and 6 o’clock antemeridian
p.000441: (or between the hours of 7 o’clock postmeridian and 7 o’clock antemeridian at sta- tions which have a
p.000441: declared workday of from 7 o’clock antemeridian to 7 o’clock postmeridian), or on Sundays or holidays, such rate, in
p.000441: lieu of compensation under any other provision of law, to be fixed at two times the basic hourly rate for
p.000441: each hour that the overtime extends beyond 6 o’clock (or 7 o’clock as the case may be)
p.000441: postmeridian, and two times the basic hourly rate for each over- time hour worked on Sundays or
p.000441: holidays. As used in this sub- section, the term ‘‘basic hourly rate’’ shall mean the regular basic
p.000441:
p.000441:
p.000441:
p.000441: January 30, 2020
p.000441: 74 Now codified to sections 191, 192, 194, and 195 of title 50, United States Code.
p.000441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000443: 443
p.000443: PUBLIC HEALTH SERVICE ACT
p.000443: Sec. 365
p.000443:
p.000443: rate of pay which is applicable to such employees for work per- formed within their regular scheduled tour
p.000443: of duty.
p.000443: (d)(1) The said extra compensation shall be paid to the United States by the owner, agent, consignee, operator, or
p.000443: master or other person in charge of any conveyance, for whom, at his request, serv- ices as described in this
p.000443: subsection (hereinafter referred to as over- time service) are performed. If such employees have been ordered
p.000443: to report for duty and have so reported, and the requested services are not performed by reason of circumstances beyond
p.000443: the control of the employees concerned, such extra compensation shall be paid on the same basis as though the
p.000443: overtime services had actually been performed during the period between the time the employees were ordered to
p.000443: report for duty and did so report, and the time they were notified that their services would not be required,
p.000443: and in any case as though their services had continued for not less than one hour. The Surgeon General
p.000443: with the approval of the Secretary of Health, Education, and Welfare may prescribe regulations requir- ing
p.000443: the owner, agent, consignee, operator, or master or other per- son for whom the overtime services are
p.000443: performed to file a bond in such amounts and containing such conditions and with such sure- ties, or in
p.000443: lieu of a bond, to deposit money or obligations of the United States in such amount, as will assure
p.000443: the payment of charges under this subsection, which bond or deposit may cover one or more transactions or all
p.000443: transactions during a specified period: Provided, That no charges shall be made for services performed in
p.000443: connection with the inspection of (1) persons arriving by inter- national highways, ferries, bridges, or
p.000443: tunnels, or the conveyances in which they arrive, or (2) persons arriving by aircraft or railroad trains, the
p.000443: operations of which are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons
p.000443: arriv- ing by vessels operated between Canadian ports and ports on Puget Sound or operated on the Great Lakes
p.000443: and connecting waterways, the operations of which are covered by published schedules, or the vessels in which they
p.000443: arrive.
p.000443: (2) Moneys collected under this subsection shall be deposited in
p.000443: the Treasury of the United States to the credit of the appropriation charged with the expense of the services, and the
p.000443: appropriations so credited shall be available for the payment of such compensation to the said employees for
p.000443: services so rendered.
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p.000443: January 30, 2020
p.000443: CERTAIN DUTIES OF CONSULAR AND OTHER OFFICERS
p.000443: SEC. 365. ø268¿ (a) Any consular or medical officer of the United States, designated for such purpose by the
p.000443: Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon
p.000443: General may prescribe, of the health con- ditions at the port or place at which such officer is stationed.
p.000443: (b) It shall be the duty of the customs officers and of Coast Guard officers to aid in the
p.000443: enforcement of quarantine rules and regulations; but no additional compensation, except actual and nec- essary
p.000443: traveling expenses, shall be allowed any such officer by rea- son of such services.
p.000443: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000443:
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p.000443: Sec. 366 PUBLIC HEALTH SERVICE ACT 444
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p.000513: privacy of patient information, and section 399B(d)(4) of this Act.
p.000513: SEC. 399F. ø280e–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000513: (a) REGISTRIES.—For the purpose of carrying out this part (other than section 399E–1), there are
p.000513: authorized to be appro- priated $30,000,000 for fiscal year 1994, and such sums as may be necessary for each of
p.000513: the fiscal years 1995 through 2003. Of the amounts appropriated under the preceding sentence for any
p.000513: such fiscal year, the Secretary may obligate not more than 25 percent for carrying out section 399C, and
p.000513: not more than 10 percent may be expended for assessing the accuracy, completeness and quality of data
p.000513: collected, and not more than 10 percent of which is to be expended under section 399D.
p.000513: (b) BREAST CANCER STUDY.—Of the amounts appropriated for the National Cancer Institute under subpart 1 of part
p.000513: C of title IV for any fiscal year in which the study required in section 399K 100 is being carried out,
p.000513: the Secretary shall expend not less than
p.000513: $1,000,000 for the study.
p.000513: PART N—NATIONAL FOUNDATION FOR THE CENTERS FOR DISEASE CONTROL AND PREVENTION
p.000513: SEC. 399G. ø280e–11¿ ESTABLISHMENT AND DUTIES OF FOUNDATION.
p.000513: (a) IN GENERAL.—There shall be established in accordance with this section a nonprofit private corporation to be
p.000513: known as the National Foundation for the Centers for Disease Control and Pre- vention (in this part referred
p.000513: to as the ‘‘Foundation’’). The Founda- tion shall not be an agency or instrumentality of the Federal Gov- ernment, and
p.000513: officers, employees, and members of the board of the Foundation shall not be officers or employees of the
p.000513: Federal Gov- ernment.
p.000513: (b) PURPOSE OF FOUNDATION.—The purpose of the Foundation shall be to support and carry out activities
p.000513: for the prevention and
p.000513:
p.000513:
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p.000513:
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p.000513: January 30, 2020
p.000513: 100 Probably should be a reference to section 399E. Section 502(2)(D)(iii) of Public Law 106–
p.000513: 310 (114 Stat. 1115) provides that subsection (b) above is amended by striking ‘‘subsection 399K’’ and
p.000513: inserting ‘‘section 399E’’. The amendment cannot be executed because the term to be struck does not
p.000513: appear in subsection (b). (Compare ‘‘subsection 399K’’ and ‘‘section 399K’’.)
p.000513: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000513:
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p.000513: Sec. 399G PUBLIC HEALTH SERVICE ACT 514
p.000513:
p.000513: control of diseases, disorders, injuries, and disabilities, and for pro- motion of public health.
p.000513: (c) ENDOWMENT FUND.—
p.000513: (1) IN GENERAL.—In carrying out subsection (b), the Foun- dation shall establish a fund for providing endowments for
p.000513: po- sitions that are associated with the Centers for Disease Control and Prevention and dedicated to the purpose
p.000513: described in such subsection. Subject to subsection (f)(1)(B), the fund shall con- sist of such donations as
p.000513: may be provided by non-Federal enti- ties and such non-Federal assets of the Foundation (including earnings of
p.000513: the Foundation and the fund) as the Foundation may elect to transfer to the fund.
p.000513: (2) AUTHORIZED EXPENDITURES OF FUND.—The provision of endowments under paragraph (1) shall be the exclusive
p.000513: func- tion of the fund established under such paragraph. Such en- dowments may be expended only for the
p.000513: compensation of indi- viduals holding the positions, for staff, equipment, quarters, travel, and other
p.000513: expenditures that are appropriate in sup- porting the positions, and for recruiting individuals to hold the
p.000513: positions endowed by the fund.
p.000513: (d) CERTAIN ACTIVITIES OF FOUNDATION.—In carrying out sub- section (b), the Foundation may provide for the
p.000513: following with re- spect to the purpose described in such subsection:
p.000513: (1) Programs of fellowships for State and local public health officials to work and study in
p.000513: association with the Cen- ters for Disease Control and Prevention.
p.000513: (2) Programs of international arrangements to provide op- portunities for public health officials of other countries to
p.000513: serve in public health capacities in the United States in association with the Centers for Disease
p.000513: Control and Prevention or else- where, or opportunities for employees of such Centers (or other public health
p.000513: officials in the United States) to serve in such ca- pacities in other countries, or both.
p.000513: (3) Studies, projects, and research (which may include ap- plied research on the effectiveness of prevention
p.000513: activities, demonstration projects, and programs and projects involving international, Federal, State, and local
p.000513: governments).
p.000513: (4) Forums for government officials and appropriate pri- vate entities to exchange information.
p.000513: Participants in such fo- rums may include institutions of higher education and appro- priate international
p.000513: organizations.
p.000513: (5) Meetings, conferences, courses, and training workshops.
p.000513: (6) Programs to improve the collection and analysis of data on the health status of various populations.
p.000513: (7) Programs for writing, editing, printing, and publishing of books and other materials.
p.000513: (8) Other activities to carry out the purpose described in subsection (b).
p.000513: (e) GENERAL STRUCTURE OF FOUNDATION; NONPROFIT STA-
p.000513: TUS.—
p.000513:
p.000513:
p.000513:
p.000513:
p.000513: January 30, 2020
p.000513: (1) BOARD OF DIRECTORS.—The Foundation shall have a board of directors (in this part referred to as the
p.000513: ‘‘Board’’), which shall be established and conducted in accordance with subsection (f). The Board shall
p.000513: establish the general policies of
p.000513: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000515: (4) APPOINTMENTS, VACANCIES, AND TERMS.—Subject to subsection (j) (regarding the initial membership of the
p.000515: Board), the following shall apply to the Board:
p.000515: (A) Any vacancy in the membership of the Board shall be filled by appointment by the Board, after consideration of
p.000515: suggestions made by the Chair and the Director regard- ing the appointments. Any such vacancy shall be filled not later
p.000515: than the expiration of the 180-day period beginning on the date on which the vacancy occurs.
p.000515: (B) The term of office of each member of the Board ap- pointed under subparagraph (A) shall be 5 years. A mem- ber of
p.000515: the Board may continue to serve after the expiration of the term of the member until the expiration of the 180- day
p.000515: period beginning on the date on which the term of the member expires.
p.000515: (C) A vacancy in the membership of the Board shall not affect the power of the Board to carry out
p.000515: the duties of the Board. If a member of the Board does not serve the full term applicable under subparagraph (B),
p.000515: the indi- vidual appointed to fill the resulting vacancy shall be ap- pointed for the remainder of the
p.000515: term of the predecessor of the individual.
p.000515: (5) COMPENSATION.—Members of the Board may not re- ceive compensation for service on the Board. The members may
p.000515: be reimbursed for travel, subsistence, and other necessary ex- penses incurred in carrying out the duties of
p.000515: the Board.
p.000515: (g) CERTAIN RESPONSIBILITIES OF EXECUTIVE DIRECTOR.—In carrying out subsection (e)(2), the Director
p.000515: shall carry out the fol- lowing functions:
p.000515: (1) Hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of
p.000515: the offi- cers and employees.
p.000515: (2) Accept and administer donations to the Foundation, and administer the assets of the Foundation.
p.000515: (3) Establish a process for the selection of candidates for holding endowed positions under subsection (c).
p.000515: (4) Enter into such financial agreements as are appro- priate in carrying out the activities of the Foundation.
p.000515: (5) Take such action as may be necessary to acquire pat- ents and licenses for devices and procedures
p.000515: developed by the Foundation and the employees of the Foundation.
p.000515: (6) Adopt, alter, and use a corporate seal, which shall be judicially noticed.
p.000515: (7) Commence and respond to judicial proceedings in the name of the Foundation.
p.000515: (8) Other functions that are appropriate in the determina- tion of the Director.
p.000515: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000515:
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p.000515:
p.000517: 517
p.000517: PUBLIC HEALTH SERVICE ACT
p.000517: Sec. 399G
p.000517:
p.000517: (h) GENERAL PROVISIONS.—
p.000517: (1) AUTHORITY FOR ACCEPTING FUNDS.—The Director of the Centers for Disease Control and Prevention may accept
p.000517: and utilize, on behalf of the Federal Government, any gift, dona- tion, bequest, or devise of real or
p.000517: personal property from the Foundation for the purpose of aiding or facilitating the work of such Centers. Funds may
p.000517: be accepted and utilized by such Di- rector under the preceding sentence without regard to whether the funds are
p.000517: designated as general-purpose funds or special- purpose funds.
p.000517: (2) AUTHORITY FOR ACCEPTANCE OF VOLUNTARY SERV- ICES.—
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p.000517: January 30, 2020
p.000517: (A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal
p.000517: Gov- ernment, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or
p.000517: facilitating the work of such Centers. In the case of an individual, such Director may accept the
p.000517: services provided under the preceding sentence by the individual until such time as the private funding for such
p.000517: individual ends.
p.000517: (B) The limitation established in subparagraph (A) re- garding the period of time in which services may be
p.000517: ac- cepted applies to each individual who is not an employee of the Federal Government and who serves
p.000517: in association with the Centers for Disease Control and Prevention pur- suant to financial support from the
p.000517: Foundation.
p.000517: (3) ADMINISTRATIVE CONTROL.—No officer, employee, or member of the Board of the Foundation may
p.000517: exercise any ad- ministrative or managerial control over any Federal employee.
p.000517: (4) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL EMPLOYEES.—In the case of any individual who is not
p.000517: an em- ployee of the Federal Government and who serves in associa- tion with the Centers for Disease Control
p.000517: and Prevention pur- suant to financial support from the Foundation, the Founda- tion shall negotiate a
p.000517: memorandum of understanding with the individual and the Director of the Centers for Disease Control and Prevention
p.000517: specifying that the individual—
p.000517: (A) shall be subject to the ethical and procedural standards regulating Federal employment, scientific
p.000517: inves- tigation, and research findings (including publications and patents) that are required of individuals
p.000517: employed by the Centers for Disease Control and Prevention, including standards under this Act, the
p.000517: Ethics in Government Act, and the Technology Transfer Act; and
p.000517: (B) shall be subject to such ethical and procedural standards under chapter 11 of title 18, United States Code
p.000517: (relating to conflicts of interest), as the Director of such Centers determines is appropriate, except
p.000517: such memo- randum may not provide that the individual shall be sub- ject to the standards of section 209 of such
p.000517: chapter.
p.000517: (5) FINANCIAL CONFLICTS OF INTEREST.—Any individual who is an officer, employee, or member of the
p.000517: Board of the Foundation may not directly or indirectly participate in the
p.000517: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000521: PUBLIC HEALTH SERVICE ACT
p.000521: Sec. 399G
p.000521:
p.000521: (A) no fewer than 2 shall have broad, general experi- ence in public health; and
p.000521: (B) no fewer than 2 shall have broad, general experi- ence in nonprofit private organizations (without
p.000521: regard to whether the individuals have experience in public health).
p.000521: (5) CHAIR.—The Committee shall, from among the mem- bers of the Committee, designate an individual to serve as
p.000521: the chair of the Committee.
p.000521: (6) TERMS; VACANCIES.—The term of members of the Com- mittee shall be for the duration of the Committee. A
p.000521: vacancy in the membership of the Committee shall not affect the power of the Committee to carry out the duties
p.000521: of the Committee. If a member of the Committee does not serve the full term, the individual appointed
p.000521: to fill the resulting vacancy shall be ap- pointed for the remainder of the term of the predecessor of the
p.000521: individual.
p.000521: (7) COMPENSATION.—Members of the Committee may not receive compensation for service on the Committee.
p.000521: Members of the Committee may be reimbursed for travel, subsistence, and other necessary expenses incurred in
p.000521: carrying out the du- ties of the Committee.
p.000521: (8) COMMITTEE SUPPORT.—The Director of the Centers for Disease Control and Prevention may, from amounts
p.000521: available to the Director for the general administration of such Centers, provide staff and financial support to
p.000521: assist the Committee with carrying out the functions described in paragraph (2). In providing such staff and
p.000521: support, the Director may both detail employees and contract for assistance.
p.000521: (9) GRANT FOR ESTABLISHMENT OF COMMITTEE.—
p.000521: (A) With respect to a grant under paragraph (1)(A)(i) of subsection (i) for fiscal year 1993, an entity
p.000521: described in this paragraph is a private nonprofit entity with signifi- cant experience in domestic and
p.000521: international issues of public health. Not later than 180 days after the date of the enactment of the
p.000521: Preventive Health Amendments of 1992 102, the Secretary shall make the grant to such an en- tity (subject to
p.000521: the availability of funds under paragraph
p.000521: (2) of such subsection).
p.000521: (B) The grant referred to in subparagraph (A) may be made to an entity only if the entity agrees that—
p.000521: (i) the entity will establish a committee that is composed in accordance with paragraph (4); and
p.000521: (ii) the entity will not select an individual for membership on the Committee unless the individual
p.000521: agrees that the Committee will operate in accordance with each of the provisions of this subsection that
p.000521: re- late to the operation of the Committee.
p.000521: (C) The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes
p.000521: an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant
p.000521: may be made only if an application for the grant is
p.000521:
p.000521:
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p.000521: January 30, 2020
p.000521: 102 Enacted October 27, 1992.
p.000521:
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000593:
p.000593: (c) USE OF FUNDS.—A grantee shall use amounts received under a grant under this section to demonstrate
p.000593: the effectiveness of research-based dental caries disease management activities.
p.000593: (d) USE OF INFORMATION.—The Secretary shall, as practicable and appropriate, utilize information generated from
p.000593: grantees under this section in planning and implementing the oral health edu- cation campaign and action
p.000593: for dental health program under sec- tion 399LL.
p.000593: SEC. 399LL–2. ø280k–2¿ AUTHORIZATION OF APPROPRIATIONS.
p.000593: There is authorized to be appropriated to carry out this part, such sums as may be necessary.
p.000593:
p.000593: PART U—EMPLOYER-BASED WELLNESS PROGRAM
p.000593:
p.000593: SEC. 399MM. ø280l¿ TECHNICAL ASSISTANCE FOR EMPLOYER-BASED WELLNESS PROGRAMS.
p.000593: In order to expand the utilization of evidence-based prevention and health promotion approaches in the workplace,
p.000593: the Director shall—
p.000593: (1) provide employers (including small, medium, and large employers, as determined by the Director) with
p.000593: technical as- sistance, consultation, tools, and other resources in evaluating such employers’
p.000593: employer-based wellness programs, includ- ing—
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p.000593: January 30, 2020
p.000593: (A) measuring the participation and methods to in- crease participation of employees in such programs;
p.000593: (B) developing standardized measures that assess pol- icy, environmental and systems changes necessary to have a
p.000593: positive health impact on employees’ health behaviors, health outcomes, and health care expenditures; and
p.000593: (C) evaluating such programs as they relate to changes in the health status of employees, the absenteeism
p.000593: of employees, the productivity of employees, the rate of workplace injury, and the medical costs incurred
p.000593: by em- ployees; and
p.000593: (2) build evaluation capacity among workplace staff by training employers on how to evaluate
p.000593: employer-based wellness programs and ensuring evaluation resources, tech- nical assistance, and consultation
p.000593: are available to workplace staff as needed through such mechanisms as web portals, call centers, or other
p.000593: means.
p.000593: SEC. 399MM–1. ø280l–1¿ NATIONAL WORKSITE HEALTH POLICIES AND PROGRAMS STUDY.
p.000593: (a) IN GENERAL.—In order to assess, analyze, and monitor over time data about workplace policies and programs,
p.000593: and to develop instruments to assess and evaluate comprehensive workplace chronic disease prevention and
p.000593: health promotion programs, policies and practices, not later than 2 years after the date of enactment of
p.000593: this part, and at regular intervals (to be determined by the Di- rector) thereafter, the Director shall
p.000593: conduct a national worksite health policies and programs survey to assess employer-based health
p.000593: policies and programs.
p.000593: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000595: PUBLIC HEALTH SERVICE ACT
p.000595: Sec. 399NN
p.000595:
p.000595: (b) REPORT.—Upon the completion of each study under sub- section (a), the Director shall submit to Congress a
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p.000601: shall be voting mem- bers. The voting members of the Board shall be the following:
p.000601: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000601: Sec. 401 PUBLIC HEALTH SERVICE ACT 602
p.000601:
p.000601: (A) Not fewer than 9 officials who are directors of na- tional research institutes or national centers. The Sec-
p.000601: retary shall designate such officials for membership and shall ensure that the group of officials so
p.000601: designated in- cludes directors of—
p.000601: (i) national research institutes whose budgets are substantial relative to a majority of the other insti-
p.000601: tutes;
p.000601: (ii) national research institutes whose budgets are small relative to a majority of the other institutes;
p.000601: (iii) national research institutes that have been in existence for a substantial period of time without sig-
p.000601: nificant organizational change under subsection (d);
p.000601: (iv) as applicable, national research institutes that have undergone significant organization changes under
p.000601: such subsection, or that have been established under such subsection, other than national research
p.000601: institutes for which such changes have been in place for a substantial period of time; and
p.000601: (v) national centers.
p.000601: (B) Members appointed by the Secretary from among individuals who are not officers or employees of the United
p.000601: States. Such members shall include—
p.000601: (i) individuals representing the interests of public or private institutions of higher education that have
p.000601: historically received funds from NIH to conduct re- search; and
p.000601: (ii) individuals representing the interests of pri- vate entities that have received funds from NIH to
p.000601: conduct research or that have broad expertise regard- ing how the National Institutes of Health
p.000601: functions, exclusive of private entities to which clause (i) applies.
p.000601: (4) CHAIR.—The Chair of the Board shall be selected by the Secretary from among the members of the Board
p.000601: appointed under paragraph (3)(B). The term of office of the Chair shall be 2 years.
p.000601: (5) MEETINGS.—
p.000601: (A) IN GENERAL.—The Board shall meet at the call of the Chair or upon the request of the Director of NIH, but
p.000601: not fewer than 5 times with respect to issuing any par- ticular report under paragraph (2)(A). The
p.000601: location of the meetings of the Board is subject to the approval of the Di- rector of NIH.
p.000601: (B) PARTICULAR FORUMS.—Of the meetings held under subparagraph (A) with respect to a report under para- graph
p.000601: (2)(A)—
p.000601: (i) one or more shall be directed toward the sci- entific community to address scientific needs and op-
p.000601: portunities related to proposals for organizational changes under subsection (d), or as the case may
p.000601: be, related to a proposal that no such changes be made; and
p.000601:
p.000601:
p.000601:
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p.000601: (ii) one or more shall be directed toward consumer organizations to address the needs and opportunities
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p.000607: (13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray
p.000607: expenses for scientific, educational, and research-related conferences;
p.000607: (14) for the national research institutes and administrative entities within the National Institutes of Health—
p.000607: (A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and
p.000607: entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal
p.000607: property, and
p.000607: (B) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise
p.000607: through the Administrator of General Services, buildings or parts of buildings in the District of Columbia
p.000607: or communities lo- cated adjacent to the District of Columbia for use for a pe- riod not to exceed ten years;
p.000607: (15) may secure resources for research conducted by or through the National Institutes of Health;
p.000607: (16) may, without regard to the provisions of title 5, United States Code, governing appointments in
p.000607: the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such
p.000607: title relating to classifica- tion and General Schedule pay rates, establish such technical and scientific
p.000607: peer review groups and scientific program advi- sory committees as are needed to carry out the
p.000607: requirements of this title and appoint and pay the members of such groups, except that officers and employees of
p.000607: the United States shall not receive additional compensation for service as members of such groups;
p.000607: (17) may secure for the National Institutes of Health con- sultation services and advice of persons from the
p.000607: United States or abroad;
p.000607: (18) may use, with their consent, the services, equipment, personnel, information, and facilities of other
p.000607: Federal, State, or local public agencies, with or without reimbursement therefor;
p.000607: (19) may, for purposes of study, admit and treat at facili- ties of the National Institutes of Health
p.000607: individuals not other- wise eligible for such treatment;
p.000607: (20) may accept voluntary and uncompensated services;
p.000607: (21) may perform such other administrative functions as the Secretary determines are needed to effectively
p.000607: carry out this title;
p.000607: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000607:
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p.000607: Sec. 402 PUBLIC HEALTH SERVICE ACT 608
p.000607:
p.000607: (22) may appoint physicians, dentists, and other health care professionals, subject to the provisions of
p.000607: title 5, United States Code, relating to appointments and classifications in the competitive service, and may
p.000607: compensate such professionals subject to the provisions of chapter 74 of title 38, United States Code;
p.000607: (23) shall designate a contact point or office to help innovators and physicians identify sources of
p.000607: funding available for pediatric medical device development;
p.000607: (24) implement the Cures Acceleration Network described in section 480; and
p.000607: (25) may require recipients of National Institutes of Health awards to share scientific data, to the extent
p.000607: feasible, gen- erated from such National Institutes of Health awards in a manner that is consistent with all
p.000607: applicable Federal laws and regulations, including such laws and regulations for the protec- tion of—
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p.000607: January 30, 2020
p.000607: (A) human research participants, including with re- spect to privacy, security, informed consent, and protected
p.000607: health information; and
p.000607: (B) proprietary interests, confidential commercial in- formation, and the intellectual property rights of the
p.000607: fund- ing recipient.
p.000607: The Federal Advisory Committee Act shall not apply to the dura- tion of a peer review group appointed
p.000607: under paragraph (16). The members of such a group shall be individuals who by virtue of their training or
p.000607: experience are eminently qualified to perform the re- view functions of such group. Not more than
p.000607: one-fourth of the members of any such group shall be officers or employees of the United States.
p.000607: (c) The Director of NIH may make available to individuals and entities, for biomedical and behavioral research,
p.000607: substances and living organisms. Such substances and organisms shall be made available under such terms
p.000607: and conditions (including payment for them) as the Secretary determines appropriate.
p.000607: (d)(1) The Director of NIH may obtain (in accordance with sec- tion 3109 of title 5, United States Code, but without
p.000607: regard to the limitation in such section on the period of service) the services of not more than 220
p.000607: experts or consultants, with scientific or other professional qualifications, for the National Institutes of
p.000607: Health.
p.000607: (2)(A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under
p.000607: paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States Code, for their
p.000607: travel to and from their place of service and for other expenses associated with their assignment.
p.000607: (B) Expenses specified in subparagraph (A) shall not be al- lowed in connection with the assignment of an
p.000607: expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in
p.000607: writing to complete the entire period of the assignment or one year of the assignment, whichever is
p.000607: shorter, unless separated or reassigned for reasons which are be- yond the control of the expert or consultant
p.000607: and which are accept- able to the Secretary. If the expert or consultant violates the agree- ment, the money spent
p.000607: by the United States for such expenses is
p.000607: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000607:
p.000607:
p.000607:
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p.000627: (v) NON-SUBMISSION OF STATEMENT.—The notice under clause (ii) for a violation described in clause (ii) shall
p.000627: include the following statement: ‘‘The entry for this clinical trial did not contain information on the
p.000627: primary and secondary outcomes at the time of sub- mission, as required by law. This may or may not have any
p.000627: bearing on the accuracy of the information in the entry.’’.
p.000627: (vi) COMPLIANCE SEARCHES.—The Director of NIH shall provide that the public may easily search the registry and
p.000627: results data bank for entries that include notices required under this subparagraph.
p.000627: (6) LIMITATION ON DISCLOSURE OF CLINICAL TRIAL INFOR- MATION.—
p.000627: (A) IN GENERAL.—Nothing in this subsection (or under section 552 of title 5, United States Code) shall require the
p.000627: Secretary to publicly disclose, by any means other than the registry and results data bank, information described
p.000627: in subparagraph (B).
p.000627: (B) INFORMATION DESCRIBED.—Information described in this subparagraph is—
p.000627: (i) information submitted to the Director of NIH under this subsection, or information of the same gen- eral
p.000627: nature as (or integrally associated with) the infor- mation so submitted; and
p.000627: (ii) information not otherwise publicly available, including because it is protected from disclosure under section
p.000627: 552 of title 5, United States Code.
p.000627: (7) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000627: $10,000,000 for each fiscal year.
p.000627: (k)(1) The Director of NIH may establish a program to provide day care services for the employees of the
p.000627: National Institutes of Health similar to those services provided by other Federal agencies (including the
p.000627: availability of day care service on a 24-hour-a-day basis).
p.000627: (2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that
p.000627: takes into consideration the income and needs of the employee.
p.000627: (3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or
p.000627: lease purchase agree- ments.
p.000627: (l) COUNCIL OF COUNCILS.—
p.000627: (1) ESTABLISHMENT.—Not later than 90 days after the date of the enactment of the National Institutes of
p.000627: Health Reform Act of 2006, the Director of NIH shall establish within the Of-
p.000627: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000627:
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p.000629: 629
p.000629: PUBLIC HEALTH SERVICE ACT
p.000629: Sec. 402
p.000629:
p.000629: fice of the Director an advisory council to be known as the ‘‘Council of Councils’’ (referred to in
p.000629: this subsection as the ‘‘Council’’) for the purpose of advising the Director on matters related to the
p.000629: policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives,
p.000629: including making recommendations with respect to the conduct and sup- port of research described in subsection (b)(7).
p.000629: (2) MEMBERSHIP.—
p.000629: (A) IN GENERAL.—The Council shall be composed of 27 members selected by the Director of NIH with approval from
...

p.000643: the report is made. Each such report shall be available to the public, and shall—
p.000643:
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p.000643: January 30, 2020
p.000643: (i) summarize and analyze expenditures made under this section;
p.000643: (ii) provide a summary of the types, numbers, and amounts of applications that were recommended for grants under
p.000643: subsection (a) but that were not ap- proved by the Director of NIH; and
p.000643: (iii) contain the recommendations of the Board for any changes in the administration of this section.
p.000643: (3) MEMBERSHIP.—
p.000643: (A) IN GENERAL.—Subject to subparagraph (B), the Board shall be composed of 15 members to be appointed by the
p.000643: Director of NIH, acting through the Office of the Direc- tor of NIH, and such ad-hoc or temporary members as the
p.000643: Director of NIH, acting through the Office of the Director of NIH, determines to be appropriate. All
p.000643: members of the
p.000643: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000643:
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p.000645: 645
p.000645: PUBLIC HEALTH SERVICE ACT
p.000645: Sec. 404I
p.000645:
p.000645: Board, including temporary and ad-hoc members, shall be voting members.
p.000645: (B) LIMITATION.—Not more than three individuals who are officers or employees of the Federal Government may
p.000645: serve as members of the Board.
p.000645: (4) CERTAIN REQUIREMENTS REGARDING MEMBERSHIP.—In selecting individuals for membership on the Board, the
p.000645: Direc- tor of NIH, acting through the Office of the Director of NIH, shall ensure that the members are
p.000645: individuals who, by virtue of their training or experience, are eminently qualified to per- form peer
p.000645: review functions. In selecting such individuals for such membership, the Director of NIH, acting through the Of-
p.000645: fice of the Director of NIH, shall ensure that the members of the Board collectively—
p.000645: (A) are experienced in the planning, construction, fi- nancing, and administration of entities that
p.000645: conduct bio- medical or behavioral research sciences;
p.000645: (B) are knowledgeable in making determinations of the need of entities for biomedical or behavioral
p.000645: research facilities, including such facilities for the dentistry, nurs- ing, pharmacy, and allied health
p.000645: professions;
p.000645: (C) are knowledgeable in evaluating the relative prior- ities for applications for grants under subsection (a)
p.000645: in view of the overall research needs of the United States; and
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p.000645: January 30, 2020
p.000645: (D) are experienced with emerging centers of excel- lence, as described in subsection (c)(2).
p.000645: (5) CERTAIN AUTHORITIES.—
p.000645: (A) WORKSHOPS AND CONFERENCES.—In carrying out paragraph (2), the Board may convene workshops and con- ferences,
p.000645: and collect data as the Board considers appro- priate.
p.000645: (B) SUBCOMMITTEES.—In carrying out paragraph (2), the Board may establish subcommittees within the Board. Such
p.000645: subcommittees may hold meetings as determined necessary to enable the subcommittee to carry out its du-
p.000645: ties.
p.000645: (6) TERMS.—
p.000645: (A) IN GENERAL.—Except as provided in subparagraph (B), each appointed member of the Board shall hold office
p.000645: for a term of 4 years. Any member appointed to fill a va- cancy occurring prior to the expiration of
p.000645: the term for which such member’s predecessor was appointed shall be appointed for the remainder of the term of
p.000645: the predecessor.
p.000645: (B) STAGGERED TERMS.—Members appointed to the Board shall serve staggered terms as specified by the
p.000645: Di- rector of NIH, acting through the Office of the Director of NIH, when making the appointments.
p.000645: (C) REAPPOINTMENT.—No member of the Board shall be eligible for reappointment to the Board until 1 year has
p.000645: elapsed after the end of the most recent term of the mem- ber.
p.000645: (7) COMPENSATION.—Members of the Board who are not of- ficers or employees of the United States shall receive
p.000645: for each
p.000645: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000645:
p.000645:
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p.000645: Sec. 404I PUBLIC HEALTH SERVICE ACT 646
p.000645:
p.000645: day the members are engaged in the performance of the func- tions of the Board compensation at the
p.000645: same rate received by members of other national advisory councils established under this title.
p.000645: (c) REQUIREMENTS FOR GRANTS.—
p.000645: (1) IN GENERAL.—The Director of NIH, acting through the Office of the Director of NIH or the National
p.000645: Institute of Al- lergy and Infectious Diseases, may make a grant under sub- section (a) only if the
p.000645: applicant for the grant meets the fol- lowing conditions:
p.000645: (A) The applicant is determined by such Director to be competent to engage in the type of research for which the
p.000645: proposed facility is to be constructed.
p.000645: (B) The applicant provides assurances satisfactory to the Director that—
p.000645: (i) for not less than 20 years after completion of the construction involved, the facility will be used
p.000645: for the purposes of the research for which it is to be con- structed;
p.000645: (ii) sufficient funds will be available to meet the non-Federal share of the cost of constructing the facil-
p.000645: ity;
p.000645: (iii) sufficient funds will be available, when con- struction is completed, for the effective use of the facil-
...

p.000651: (e) AWARD OF CONTRACT FOR OPERATION OF SYSTEM.—
p.000651: (1) IN GENERAL.—Subject to the availability of funds pur- suant to subsection (g), the Secretary shall
p.000651: make an award of a contract to a nonprofit private entity under which the entity has the responsibility of
p.000651: operating (and establishing, as appli- cable) the sanctuary system and awarding subcontracts or grants to
p.000651: individual sanctuary facilities that meet the stand- ards under subsection (d).
p.000651: (2) REQUIREMENTS.—The Secretary may make an award under paragraph (1) to a nonprofit private entity only if the
p.000651: en- tity meets the following requirements:
p.000651: (A) The entity has a governing board of directors that is composed and appointed in accordance with paragraph
p.000651: (3) and is satisfactory to the Secretary.
p.000651: (B) The terms of service for members of such board are in accordance with paragraph (3).
p.000651: (C) The members of the board serve without com- pensation. The members may be reimbursed for travel,
p.000651: subsistence, and other necessary expenses incurred in car- rying out the duties of the board.
p.000651: (D) The entity has an executive director meeting such requirements as the Secretary determines to be appro-
p.000651: priate.
p.000651: (E) The entity makes the agreement described in para- graph (4) (relating to non-Federal contributions).
p.000651: (F) The entity agrees to comply with standards under subsection (d).
p.000651: (G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a
p.000651: rea- sonable basis to persons who conduct biomedical or behav- ioral research, with priority given to such persons who
p.000651: are Federal employees or who receive financial support from the Federal Government for research.
p.000651: (H) Such other requirements as the Secretary deter- mines to be appropriate.
p.000651: (3) BOARD OF DIRECTORS.—For purposes of subparagraphs
p.000651: (A) and (B) of paragraph (2):
p.000651: (A) The governing board of directors of the nonprofit private entity involved is composed and appointed
p.000651: in ac- cordance with this paragraph if the following conditions are met:
p.000651:
p.000651:
p.000651:
p.000651:
p.000651:
p.000651:
p.000651:
p.000651: January 30, 2020
p.000651: (i) Such board is composed of not more than 13 voting members.
p.000651: (ii) Such members include individuals with exper- tise and experience in the science of managing captive chimpanzees
p.000651: (including primate veterinary care), ap- pointed from among individuals endorsed by organiza- tions that represent
p.000651: individuals in such field.
p.000651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000653: PUBLIC HEALTH SERVICE ACT
p.000653: Sec. 404K
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p.000659: the Secretary. The ex officio members shall be nonvoting members.
p.000659: (2) The ex officio members of an advisory council shall consist
p.000659:
p.000659:
p.000659: January 30, 2020
p.000659: of—
p.000659:
p.000659: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000661: 661
p.000661: PUBLIC HEALTH SERVICE ACT
p.000661: Sec. 406
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p.000661: January 30, 2020
p.000661: (A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is
p.000661: established, the Chief Medical Director of the Department of Veterans Af- fairs or the Chief Dental
p.000661: Director of the Department of Vet- erans Affairs, and the Assistant Secretary of Defense for
p.000661: Health Affairs (or the designees of such officers), and
p.000661: (B) such additional officers or employees of the United States as the Secretary determines necessary for
p.000661: the advisory council to effectively carry out its functions.
p.000661: (3) The members of an advisory council who are not ex officio members shall be appointed as follows:
p.000661: (A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of
p.000661: the health and scientific disciplines (including not less than two individ- uals who are leaders in the fields
p.000661: of public health and the be- havioral or social sciences) relevant to the activities of the na- tional research
p.000661: institute for which the advisory council is es- tablished.
p.000661: (B) One-third of the members shall be appointed by the Secretary from the general public and shall
p.000661: include leaders in fields of public policy, law, health policy, economics, and man- agement.
p.000661: (4) Members of an advisory council who are officers or employ- ees of the United States shall not receive any
p.000661: compensation for service on the advisory council. The other members of an advisory council shall receive, for each
p.000661: day (including traveltime) they are engaged in the performance of the functions of the advisory council,
p.000661: compensation at rates not to exceed the daily equivalent of the an- nual rate in effect for grade GS–18 of the General
p.000661: Schedule.
p.000661: (c) The term of office of an appointed member of an advisory council is four years, except that any
p.000661: member appointed to fill a vacancy for an unexpired term shall be appointed for the remain- der of such
p.000661: term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the
...

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p.000695: 695
p.000695: PUBLIC HEALTH SERVICE ACT
p.000695: Sec. 417F
p.000695:
p.000695: (i) Not more than 7 voting Federal representatives as follows:
p.000695: (I) The Director of the Centers for Disease Control and Prevention.
p.000695: (II) The Director of the National Institutes of Health and the directors of such national research institutes
p.000695: and national centers (which may in- clude the National Institute of Environmental Health Sciences) as
p.000695: the Secretary determines ap- propriate.
p.000695: (III) One representative from the National Cancer Institute Board of Scientific Advisors, ap- pointed
p.000695: by the Director of the National Cancer In- stitute.
p.000695: (IV) The heads of such other agencies of the Department of Health and Human Services as the Secretary
p.000695: determines appropriate.
p.000695: (V) Representatives of other Federal agencies that conduct or support cancer research, including the Department of
p.000695: Defense.
p.000695: (ii) 12 additional voting members appointed under subparagraph (B).
p.000695: (B) ADDITIONAL MEMBERS.—The Committee shall in- clude additional voting members appointed by the Sec-
p.000695: retary as follows:
p.000695: (i) 6 members shall be appointed from among sci- entists, physicians, and other health professionals, who—
p.000695:
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p.000695: January 30, 2020
p.000695: (I) are not officers or employees of the United States;
p.000695: (II) represent multiple disciplines, including clinical, basic, and public health sciences;
p.000695: (III) represent different geographical regions of the United States;
p.000695: (IV) are from practice settings, academia, or other research settings; and
p.000695: (V) are experienced in scientific peer review process.
p.000695: (ii) 6 members shall be appointed from members of the general public, who represent individuals with
p.000695: breast cancer.
p.000695: (C) NONVOTING MEMBERS.—The Committee shall in- clude such nonvoting members as the Secretary deter- mines
p.000695: to be appropriate.
p.000695: (5) CHAIRPERSON.—The voting members of the Committee shall select a chairperson from among such members.
p.000695: The se- lection of a chairperson shall be subject to the approval of the Director of NIH.
p.000695: (6) MEETINGS.—The Committee shall meet at the call of the chairperson of the Committee or upon the
p.000695: request of the Director of NIH, but in no case less often than once each year.
p.000695: (b) REVIEW.—The Secretary shall review the necessity of the Committee in calendar year 2011 and,
p.000695: thereafter, at least once every 2 years.
p.000695: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000695:
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p.000703: (2) to coordinate the activities of the Center with similar activities of other Federal agencies,
p.000703: including the other agen- cies of the National Institutes of Health, and similar activities of other public entities
p.000703: and nonprofit entities.
p.000703:
p.000703:
p.000703:
p.000703: January 30, 2020
p.000703: 19 Now Ruth L. Kirschstein National Research Service Awards. See section 487.
p.000703: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000703:
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p.000703: Sec. 424 PUBLIC HEALTH SERVICE ACT 704
p.000703:
p.000703: (c)(1) The Director of the National Institutes of Health shall es- tablish a board to be known as the Sleep Disorders
p.000703: Research Advi- sory Board (in this section referred to as the ‘‘Advisory Board’’).
p.000703: (2) The Advisory Board shall advise, assist, consult with, and make recommendations to the Director of
p.000703: the National Institutes of Health, through the Director of the Institute, and the Director of the Center
p.000703: concerning matters relating to the scientific activities carried out by and through the Center and the
p.000703: policies respecting such activities, including recommendations with respect to the plan required in subsection (c) 20.
p.000703: (3)(A) The Director of the National Institutes of Health shall appoint to the Advisory Board 12 appropriately
p.000703: qualified represent- atives of the public who are not officers or employees of the Federal Government. Of such
p.000703: members, eight shall be representatives of health and scientific disciplines with respect to sleep disorders and
p.000703: four shall be individuals representing the interests of individuals with or undergoing treatment for sleep
p.000703: disorders.
p.000703: (B) The following officials shall serve as ex officio members of the Advisory Board:
p.000703: (i) The Director of the National Institutes of Health.
p.000703: (ii) The Director of the Center.
p.000703: (iii) The Director of the National Heart, Lung and Blood Institute.
p.000703: (iv) The Director of the National Institute of Mental Health.
p.000703: (v) The Director of the National Institute on Aging.
p.000703: (vi) The Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
p.000703: (vii) The Director of the National Institute of Neurological Disorders and Stroke.
p.000703: (viii) The Assistant Secretary for Health.
p.000703: (ix) The Assistant Secretary of Defense (Health Affairs).
p.000703: (x) The Chief Medical Director of the Veterans’ Adminis- tration.
p.000703: (4) The members of the Advisory Board shall, from among the members of the Advisory Board, designate an
p.000703: individual to serve as the chair of the Advisory Board.
p.000703: (5) Except as inconsistent with, or inapplicable to, this section, the provisions of section 406 shall apply to the
p.000703: advisory board 21 es- tablished under this section in the same manner as such provisions apply to any advisory council
p.000703: established under such section.
p.000703: (d)(1) After consultation with the Director of the Center and the advisory board established under subsection
...

p.000709: involved in re- search with respect to the diseases for which the Committee is es- tablished, the Division Director
p.000709: of the Institute for the diseases for which the Committee is established, the Chief Medical Director of the
p.000709: Veterans’ Administration, and the Assistant Secretary of De- fense for Health Affairs (or the designees of such
p.000709: officers) and shall include representation from all other Federal departments and agencies whose programs
p.000709: involve health functions or responsibil- ities relevant to such diseases, as determined by the Secretary.
p.000709: Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee
p.000709: shall meet at the call of the chairman, but not less often than four times a year.
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p.000709: January 30, 2020
p.000709: ADVISORY BOARDS
p.000709: SEC. 430. ø285c–4¿ (a) The Secretary shall establish in the In- stitute the National Diabetes Advisory Board, the
p.000709: National Diges- tive Diseases Advisory Board, and the National Kidney and Uro- logic Diseases Advisory Board
p.000709: (hereafter in this section individually referred to as an ‘‘Advisory Board’’).
p.000709: (b) Each Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000709: follows:
p.000709: (1) The Secretary shall appoint—
p.000709: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000709: not officers or employees of the United States, and who represent the specialties and disciplines
p.000709: relevant to the diseases with respect to which the Advisory Board is es- tablished; and
p.000709: (B) six members from the general public who are knowledgeable with respect to such diseases, including
p.000709: at least one member who is a person who has such a disease and one member who is a parent of a person who has such a
p.000709: disease.
p.000709: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in the fields of
p.000709: health edu-
p.000709: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000709:
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p.000709: Sec. 430 PUBLIC HEALTH SERVICE ACT 710
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p.000709: January 30, 2020
p.000709:
p.000709: cation, nursing, data systems, public information, and commu- nity program development.
p.000709: (2)(A) The following shall be ex officio members of each Ad- visory Board:
p.000709: (i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and
p.000709: Digestive and Kidney Diseases, the Director of the Centers for Disease Control and Prevention, the Chief Medical Di-
p.000709: rector of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, and the
p.000709: Division Director of the National Institute of Diabetes and Diges- tive and Kidney Diseases for the
p.000709: diseases for which the Board is established (or the designees of such officers).
p.000709: (ii) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000709: sory Board to carry out its functions.
p.000709: (B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio
p.000709: members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute,
p.000709: the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Devel- opment, and
p.000709: the Administrator of the Health Resources and Services Administration (or the designees of such officers).
p.000709: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000709: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000709: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000709: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000709: engaged in the per- formance of their duties as members of the Board.
p.000709: (d) The term of office of an appointed member of an Advisory Board is four years, except that no term
p.000709: of office may extend be- yond the expiration of the Advisory Board. Any member appointed to fill a vacancy for
p.000709: an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of
p.000709: the member’s term until a successor has taken office. If a va- cancy occurs in an Advisory Board, the
p.000709: Secretary shall make an ap- pointment to fill the vacancy not later than 90 days from the date the vacancy occurred.
...

p.000719: African-Amer- ican women.
p.000719: (2) Basic research concerning the etiology and causes of the disease.
p.000719: (3) Epidemiological studies to address the frequency and natural history of the disease and the
p.000719: differences among the sexes and among racial and ethnic groups with respect to the disease.
p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
p.000719: members who are parents of children with arthritis.
p.000719: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in health
p.000719: education, nurs- ing, data systems, public information, or community program development.
p.000719: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000719:
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p.000721: 721
p.000721: PUBLIC HEALTH SERVICE ACT
p.000721: Sec. 442
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p.000721: January 30, 2020
p.000721: (2) The following shall be ex officio members of the Advi- sory Board:
p.000721: (A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and
p.000721: Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the
p.000721: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000721: Health Affairs (or the designees of such officers), and
p.000721: (B) such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000721: sory Board to carry out its functions.
p.000721: (c) Members of the Advisory Board who are officers or employ- ees of the Federal Government shall serve as members of
p.000721: the Advi- sory Board without compensation in addition to that received in their regular public employment.
p.000721: Other members of the Advisory Board shall receive compensation at rates not to exceed the daily
p.000721: equivalent of the annual rate in effect for grade GS–18 of the Gen- eral Schedule for each day (including traveltime)
p.000721: they are engaged in the performance of their duties as members of the Advisory Board.
p.000721: (d) The term of office of an appointed member of the Advisory Board is four years. Any member appointed to fill a
p.000721: vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the
p.000721: expiration of the member’s term until a successor has taken office. If a vacancy occurs in the Advi- sory Board,
p.000721: the Secretary shall make an appointment to fill the va- cancy not later than 90 days after the date the
p.000721: vacancy occurred.
p.000721: (e) The members of the Advisory Board shall select a chairman from among the appointed members.
p.000721: (f) The Secretary shall, after consultation with and consider- ation of the recommendations of the
p.000721: Advisory Board, provide the Advisory Board with an executive director and one other profes- sional staff
p.000721: member. In addition, the Secretary shall, after con- sultation with and consideration of the recommendations of
p.000721: the Ad- visory Board, provide the Advisory Board with such additional pro- fessional staff members, such clerical staff
...

p.000731: are car- ried out in conjunction with other agencies of the National Insti- tutes of Health and with
p.000731: other agencies of the Federal Govern- ment.
p.000731: (3) The Coordinating Committee shall be composed of the Di- rector of the Division of Program Coordination,
p.000731: Planning, and Stra- tegic Initiatives within the Office of the Director of the National In- stitutes of Health, the
p.000731: Director of the Center, the Director of the Institute, and the Directors of the National Institute on Aging, the
p.000731: National Institute of Arthritis and Musculoskeletal and Skin Dis- eases, the National Heart, Lung, and Blood
p.000731: Institute, the National Institute of Neurological Disorders and Stroke, and such other na- tional research institutes
p.000731: and such representatives of other agen- cies of the Federal Government as the Director of NIH determines to be
p.000731: appropriate.
p.000731: (4) The Coordinating Committee shall be chaired by the Direc- tor of the Center.
p.000731: (f)(1) Not later than 90 days after the date of the enactment of the National Institutes of Health
p.000731: Revitalization Amendments of 1990, 34 the Director of NIH shall establish a National Advisory Board on
p.000731: Medical Rehabilitation Research (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000731: (2) The Advisory Board shall review and assess Federal re- search priorities, activities, and findings
p.000731: regarding medical reha- bilitation research, and shall advise the Director of the Center and the Director of the
p.000731: Institute on the provisions of the Research Plan. (3)(A) The Director of NIH shall appoint to the Advisory Board
p.000731: 18 qualified representatives of the public who are not officers or employees of the Federal Government.
p.000731: Of such members, 12 shall be representatives of health and scientific disciplines with respect to medical
p.000731: rehabilitation and 6 shall be individuals representing the interests of individuals undergoing, or in need of,
p.000731: medical reha- bilitation.
p.000731: (B) The following officials shall serve as ex officio members of the Advisory Board:
p.000731: (i) The Director of the Center.
p.000731:
p.000731:
p.000731:
p.000731: January 30, 2020
p.000731: 34 See footnote for subsection (d)(3)(A).
p.000731:
p.000731: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000731:
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p.000733: 733
p.000733: PUBLIC HEALTH SERVICE ACT
p.000733: Sec. 452A
p.000733:
p.000733: (ii) The Director of the Institute.
p.000733: (iii) The Director of the National Institute on Aging.
p.000733: (iv) The Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
p.000733: (v) The Director of the National Institute on Deafness and Other Communication Disorders.
p.000733: (vi) The Director of the National Heart, Lung, and Blood Institute.
p.000733: (vii) The Director of the National Institute of Neurological Disorders and Stroke.
p.000733: (viii) The Director of the National Institute on Disability and Rehabilitation Research.
p.000733: (ix) The Director of the Division of Program Coordination, Planning, and Strategic Initiatives.
p.000733: (x) The Commissioner for Rehabilitation Services Adminis- tration.
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p.000743: 743
p.000743: PUBLIC HEALTH SERVICE ACT
p.000743: Sec. 464D
p.000743:
p.000743: sory council, if such group has recommended to the Director that such period should be extended.
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p.000743: January 30, 2020
p.000743: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY BOARD
p.000743: SEC. 464D. ø285m–4¿ (a) The Secretary shall establish in the Institute the National Deafness and Other
p.000743: Communications Dis- orders Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000743: (b) The Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000743: follows:
p.000743: (1) The Secretary shall appoint—
p.000743: (A) twelve members from individuals who are sci- entists, physicians, and other health and rehabilitation
p.000743: professionals, who are not officers or employees of the United States, and who represent the specialties
p.000743: and dis- ciplines relevant to deafness and other communication dis- orders, including not less than two persons with a
p.000743: commu- nication disorder; and
p.000743: (B) six members from the general public who are knowledgeable with respect to such disorders, including
p.000743: not less than one person with a communication disorder and not less than one person who is a parent
p.000743: of an indi- vidual with such a disorder.
p.000743: Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in
p.000743: diagnoses and re- habilitation of communication disorders, education of the hear- ing, speech, or language
p.000743: impaired, public health, public infor- mation, community program development, occupational haz- ards to
p.000743: communications senses, or the aging process.
p.000743: (2) The following shall be ex officio members of each Advi- sory Board:
p.000743: (A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness
p.000743: and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the
p.000743: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000743: Health Affairs (or the designees of such officers).
p.000743: (B) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000743: sory Board to carry out its functions.
p.000743: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000743: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000743: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000743: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
p.000743: engaged in the per- formance of their duties as members of the Board.
p.000743: (d) The term of office of an appointed member of the Advisory Board is four years, except that no term of
p.000743: office may extend be- yond the expiration of the Advisory Board. Any member appointed
p.000743: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000743:
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p.000743: Sec. 464E PUBLIC HEALTH SERVICE ACT 744
p.000743:
p.000743: to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may
p.000743: serve after the expiration of the member’s term until a successor has taken office. If a va- cancy occurs
p.000743: in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90
p.000743: days from the date the vacancy occurred.
...

p.000755: incorrect section. (The conforming amendment ap- plied to section 485. Section 464X formerly was section 485,
p.000755: and was redesignated by section 1511(b)(2)(B) of Public Law 103–43 (107 Stat. 179).)
p.000755: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000755: Sec. 464X PUBLIC HEALTH SERVICE ACT 756
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p.000755: January 30, 2020
p.000755:
p.000755: (A) the Secretary, the Director of NIH, the Director of the Institute, the chief nursing officer of the
p.000755: Department of Vet- erans Affairs, the Assistant Secretary of Defense for Health Af- fairs, the Director of the
p.000755: Division of Nursing of the Health Re- sources and Services Administration (or the designees of such officers),
p.000755: and
p.000755: (B) such additional officers or employees of the United States as the Secretary determines necessary for
p.000755: the advisory council to effectively carry out its functions.
p.000755: (3) The members of the advisory council who are not ex officio members shall be appointed as follows:
p.000755: (A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of
p.000755: the health and scientific disciplines (including public health and the be- havioral or social sciences)
p.000755: relevant to the activities of the In- stitute. Of the members appointed pursuant to this subpara- graph,
p.000755: at least seven shall be professional nurses who are rec- ognized experts in the area of clinical practice, education,
p.000755: or re- search.
p.000755: (B) One-third of the members shall be appointed by the Secretary from the general public and shall
p.000755: include leaders in fields of public policy, law, health policy, economics, and man- agement.
p.000755: (4) Members of the advisory council who are officers or employ- ees of the United States shall not receive any
p.000755: compensation for service on the advisory council. The other members of the advisory council shall receive, for
p.000755: each day (including traveltime) they are engaged in the performance of the functions of the advisory council,
p.000755: compensation at rates not to exceed the daily equivalent of the an- nual rate in effect for grade GS–18 of the General
p.000755: Schedule.
p.000755: (c) The term of office of an appointed member of the advisory council is four years, except that any
p.000755: member appointed to fill a vacancy for an unexpired term shall be appointed for the remain- der of such
...

p.000757: image-guided interventions).
p.000757: (3)(A) With respect to the Program, the Director of the Insti- tute shall prepare and transmit to the
p.000757: Secretary and the Director of NIH a plan to initiate, expand, intensify, and coordinate activi- ties of
p.000757: the Institute with respect to biomedical imaging and bio- engineering. The plan shall include such
p.000757: comments and rec- ommendations as the Director of the Institute determines appro- priate. The Director
p.000757: of the Institute shall periodically review and revise the plan and shall transmit any revisions of the plan to
p.000757: the Secretary and the Director of NIH.
p.000757: (B) The plan under subparagraph (A) shall include the rec- ommendations of the Director of the Institute
p.000757: with respect to the following:
p.000757: (i) Where appropriate, the consolidation of programs of the National Institutes of Health for the express
p.000757: purpose of en- hancing support of activities regarding basic biomedical imag- ing and bioengineering research.
p.000757: (ii) The coordination of the activities of the Institute with related activities of the other agencies
p.000757: of the National Insti- tutes of Health and with related activities of other Federal agencies.
p.000757: (c) The establishment under section 406 of an advisory council for the Institute is subject to the following:
p.000757: (1) The number of members appointed by the Secretary shall be 12.
p.000757: (2) Of such members—
p.000757: (A) six members shall be scientists, engineers, physi- cians, and other health professionals who represent
p.000757: dis- ciplines in biomedical imaging and bioengineering and who are not officers or employees of the United States; and
p.000757: (B) six members shall be scientists, engineers, physi- cians, and other health professionals who represent
p.000757: other disciplines and are knowledgeable about the applications of biomedical imaging and bioengineering in
p.000757: medicine, and who are not officers or employees of the United States.
p.000757: (3) In addition to the ex officio members specified in sec- tion 406(b)(2), the ex officio members of
p.000757: the advisory council shall include the Director of the Centers for Disease Control and Prevention, the
p.000757: Director of the National Science Founda- tion, and the Director of the National Institute of Standards
p.000757: and Technology (or the designees of such officers).
p.000757:
p.000757:
p.000757:
p.000757:
p.000757: January 30, 2020 As Amended Through P.L. 116-94,
p.000757: Enacted December 20, 2019
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p.000759: 759
p.000759: PUBLIC HEALTH SERVICE ACT
p.000759: Sec. 464z–3
p.000759:
p.000759: Subpart 19—National Human Genome Research Institute
p.000759: PURPOSE OF THE CENTER 46
p.000759: SEC. 464z–1. ø285s¿ (a) The general purpose of the National Human Genome Research Institute (in this
p.000759: subpart referred to as the ‘‘Institute’’) is to characterize the structure and function of the human genome,
p.000759: including the mapping and sequencing of indi- vidual genes. Such purpose includes—
p.000759: (1) planning and coordinating the research goal of the ge- nome project;
p.000759: (2) reviewing and funding research proposals;
p.000759: (3) developing training programs;
p.000759: (4) coordinating international genome research;
p.000759: (5) communicating advances in genome science to the pub- lic; and
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p.000777: January 30, 2020
p.000777:
p.000777: bers, with diverse representation as described in clause (iii).
p.000777: (ii) CHAIRPERSON OR VICE CHAIRPERSON.—Each meeting of the Board shall be attended by either the
p.000777: Chairperson or the Vice Chairperson.
p.000777: (iii) DIVERSE REPRESENTATION.—At each meeting of the Board, there shall be not less than one scientist, one
p.000777: representative of a disease advocacy organization, and one representative of a professional venture cap- ital or
p.000777: private equity organization.
p.000777: (6) COMPENSATION AND TRAVEL EXPENSES.—
p.000777: (A) COMPENSATION.—Members shall receive compensa- tion at a rate to be fixed by the Chairperson but not to ex- ceed a
p.000777: rate equal to the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Sched- ule
p.000777: under section 5315 of title 5, United States Code, for each day (including travel time) during which the
p.000777: member is engaged in the performance of the duties of the Board. All members of the Board who are officers or
p.000777: employees of the United States shall serve without compensation in ad- dition to that received for their services
p.000777: as officers or em- ployees of the United States.
p.000777: (B) TRAVEL EXPENSES.—Members of the Board shall be allowed travel expenses, including per diem in lieu of sub-
p.000777: sistence, at rates authorized for persons employed inter- mittently by the Federal Government under
p.000777: section 5703(b) of title 5, United States Code, while away from their homes or regular places of
p.000777: business in the perform- ance of services for the Board.
p.000777: (e) GRANT PROGRAM.—
p.000777: (1) SUPPORTING INNOVATION.—To carry out the purposes described in this section, the Director of the
p.000777: Center shall award contracts, grants, or cooperative agreements to the enti- ties described in paragraph (2), to—
p.000777: (A) promote innovation in technologies supporting the advanced research and development and production
p.000777: of high need cures, including through the development of medical products and behavioral therapies.
p.000777: (B) accelerate the development of high need cures, in- cluding through the development of medical products, be-
p.000777: havioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products; or
p.000777: (C) help the award recipient establish protocols that comply with Food and Drug Administration standards and
p.000777: otherwise permit the recipient to meet regulatory require- ments at all stages of development, manufacturing, review,
p.000777: approval, and safety surveillance of a medical product.
p.000777: (2) ELIGIBLE ENTITIES.—To receive assistance under para- graph (1), an entity shall—
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p.000787: PUBLIC HEALTH SERVICE ACT
p.000787: Sec. 486
p.000787:
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p.000787: January 30, 2020
p.000787: groups) is an appropriate function of clinical trials of treat- ments and therapies;
p.000787: (D) supporting the development and expansion of clin- ical trials of treatments and therapies for which obtaining such
p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
p.000787: Advi- sory Committee on Research on Women’s Health (in this sub- section referred to as the ‘‘Advisory
p.000787: Committee’’).
p.000787: (2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not
p.000787: officers or employees of the Federal Government. The Director of NIH shall make appointments to the Advisory
p.000787: Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical
p.000787: practice, research specialization, or professional expertise includes a significant focus on re- search on
p.000787: women’s health. A majority of the members of the Advisory Committee shall be women.
p.000787: (3) The Director of the Office shall serve as the chair of the Advisory Committee.
p.000787: (4) The Advisory Committee shall—
p.000787: (A) advise the Director of the Office on appropriate re- search activities to be undertaken by the national research
p.000787: institutes with respect to—
p.000787: (i) research on women’s health;
p.000787: (ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
p.000787: (iii) research on gender differences in disease eti- ology, course, and treatment;
p.000787: (iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and
p.000787: (v) research on women’s health conditions which require a multidisciplinary approach;
p.000787: (B) report to the Director of the Office on such re- search;
p.000787: (C) provide recommendations to such Director regard- ing activities of the Office (including
...

p.000791: such individual in accordance with paragraphs (1) and
p.000791: (2) of this subsection.
p.000791: (B) Any amount which the United States is entitled to recover under subparagraph (A) shall, within the three-year
p.000791: period begin- ning on the date the United States becomes entitled to recover such amount, be paid to the United
p.000791: States. Until any amount due the United States under subparagraph (A) on account of any Ruth L.
p.000791: Kirschstein National Research Service Award is paid, there shall accrue to the United States interest on such
p.000791: amount at a rate fixed by the Secretary of the Treasury after taking into consideration private consumer
p.000791: rates of interest prevailing on the date the United States becomes entitled to such amount.
p.000791: (5)(A) Any obligation of an individual under paragraph (1) shall be canceled upon the death of such individual.
p.000791: (B) The Secretary shall by regulation provide for the waiver or suspension of any such obligation applicable to
p.000791: any individual whenever compliance by such individual is impossible or would in- volve substantial hardship to
p.000791: such individual or would be against equity and good conscience.
p.000791: INTRAMURAL LOAN REPAYMENT PROGRAM 54
p.000791: SEC. 487A. ø288–1¿ (a) IN GENERAL.—The Director of the Na- tional Institutes of Health shall, as appropriate and based
p.000791: on work- force and scientific priorities, carry out a program through the sub- categories listed in subsection
p.000791: (b)(1) (or modified subcategories as provided for in subsection (b)(2)) of entering into agreements with
p.000791: appropriately qualified health professionals under which such health professionals agree to conduct
p.000791: research, as employees of the National Institutes of Health, in consideration of the Federal Gov- ernment agreeing to
p.000791: repay, for each year of such service, not more
p.000791:
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p.000791:
p.000791: January 30, 2020
p.000791: 54 The font/style of the section heading shown above conforms with the style of the original section
p.000791: heading for section 487A in all small caps centered heading. See typeface for the amend- ment made by section
p.000791: 2022(a)(1) of Public Law 114–255.
p.000791: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000793: PUBLIC HEALTH SERVICE ACT
p.000793: Sec. 487B
p.000793:
p.000793: than $50,000 of the principal and interest of the educational loans of such health professionals.
p.000793: (b) SUBCATEGORIES OF RESEARCH.—
p.000793: (1) IN GENERAL.—In carrying out the program under sub- section (a), the Director of the National
p.000793: Institutes of Health—
p.000793: (A) shall continue to focus on—
p.000793: (i) general research;
p.000793: (ii) research on acquired immune deficiency syn- drome; and
p.000793: (iii) clinical research conducted by appropriately qualified health professional who are from disadvan-
p.000793: taged backgrounds; and
p.000793: (B) may focus on an area of emerging scientific or workforce need.
p.000793: (2) ELIMINATION OR ESTABLISHMENT OF SUBCATEGORIES.— The Director of the National Institutes of Health may
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p.000793: (e) AVAILABILITY OF APPROPRIATIONS.—Amounts available for carrying out this section shall remain available until
p.000793: the expiration of the second fiscal year beginning after the fiscal year for which the amounts were made
p.000793: available.
p.000793: øSection 487C was repealed by section 2022(c)(2) of Public Law 114–255.¿
p.000793:
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p.000793: January 30, 2020
p.000793: UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY NATIONAL RESEARCH INSTITUTES
p.000793: SEC. 487D. ø288–4¿ (a) ESTABLISHMENT OF PROGRAM.—
p.000793: (1) IN GENERAL.—Subject to section 487(a)(1)(C), the Sec- retary, acting through the Director of NIH, may
p.000793: carry out a program of entering into contracts with individuals described in paragraph (2) under which—
p.000793: (A) the Director of NIH agrees to provide to the indi- viduals scholarships for pursuing, as
p.000793: undergraduates at accredited institutions of higher education, academic pro-
p.000793: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000795: PUBLIC HEALTH SERVICE ACT
p.000795: Sec. 487D
p.000795:
p.000795: grams appropriate for careers in professions needed by the National Institutes of Health; and
p.000795: (B) the individuals agree to serve as employees of the National Institutes of Health, for the period described
p.000795: in subsection (c), in positions that are needed by the National Institutes of Health and for which the
p.000795: individuals are qualified.
p.000795: (2) INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.— The individuals referred to in paragraph (1) are
p.000795: individuals who—
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p.000795: (A) are enrolled or accepted for enrollment as full-time undergraduates at accredited institutions of higher edu-
p.000795: cation; and
p.000795: (B) are from disadvantaged backgrounds.
p.000795: (b) FACILITATION OF INTEREST OF STUDENTS IN CAREERS AT NA- TIONAL INSTITUTES OF HEALTH.—In providing
p.000795: employment to indi- viduals pursuant to contracts under subsection (a)(1), the Director of NIH shall carry
p.000795: out activities to facilitate the interest of the in- dividuals in pursuing careers as employees of the National
p.000795: Insti- tutes of Health.
p.000795: (c) PERIOD OF OBLIGATED SERVICE.—
p.000795: (1) DURATION OF SERVICE.—For purposes of subparagraph
p.000795: (B) of subsection (a)(1), the period of service for which an indi- vidual is obligated to serve as an employee of the
p.000795: National In- stitutes of Health is, subject to paragraph (2)(A), 12 months for each academic year for which the
p.000795: scholarship under such sub- section is provided.
p.000795: (2) SCHEDULE FOR SERVICE.—
p.000795: (A) Subject to subparagraph (B), the Director of NIH may not provide a scholarship under subsection (a) unless
p.000795: the individual applying for the scholarship agrees that—
p.000795: (i) the individual will serve as an employee of the National Institutes of Health full-time for not less than
p.000795: 10 consecutive weeks of each year during which the individual is attending the educational institution
p.000795: involved and receiving such a scholarship;
p.000795: (ii) the period of service as such an employee that the individual is obligated to provide under clause (i) is
p.000795: in addition to the period of service as such an em- ployee that the individual is obligated to
p.000795: provide under subsection (a)(1)(B); and
p.000795: (iii) not later than 60 days after obtaining the educational degree involved, the individual will begin
p.000795: serving full-time as such an employee in satisfaction of the period of service that the individual is obligated to
p.000795: provide under subsection (a)(1)(B).
p.000795: (B) The Director of NIH may defer the obligation of an individual to provide a period of service under
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p.000801: the 30-day period beginning on the date on which the statement required in subparagraph (A) is made
p.000801: with re- spect to the board.
p.000801: (5) ETHICS ADVISORY BOARDS.—
p.000801: (A) Any advisory board convened for purposes of para- graph (1) shall be known as an ethics advisory board
p.000801: (in this paragraph referred to as an ‘‘ethics board’’).
p.000801: (B)(i) An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the eth-
p.000801: ics of the project of biomedical or behavioral research with respect to which the board has been convened.
p.000801: (ii) Not later than 180 days after the date on which the statement required in paragraph (4)(A) is
p.000801: made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on
p.000801: Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the
p.000801: Senate, a report de- scribing the findings of the board regarding the project of research involved and
p.000801: making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for
p.000801: the project. The report shall include the information considered in making the findings.
p.000801: (C) An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not
p.000801: officers or employees of the United States. The Secretary shall make appointments to the board from among
p.000801: individuals with special qualifications and competence to provide ad- vice and recommendations regarding
p.000801: ethical matters in biomedical and behavioral research. Of the members of the board—
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p.000801: (i) no fewer than 1 shall be an attorney;
p.000801: (ii) no fewer than 1 shall be an ethicist;
p.000801: (iii) no fewer than 1 shall be a practicing physi- cian;
p.000801: (iv) no fewer than 1 shall be a theologian; and
p.000801: (v) no fewer than one-third, and no more than one-half, shall be scientists with substantial accom-
p.000801: plishments in biomedical or behavioral research.
p.000801: (D) The term of service as a member of an ethics board shall be for the life of the board. If such
p.000801: a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy
p.000801: shall be appointed for the remainder of the term of the predecessor of the in- dividual.
p.000801: (E) A member of an ethics board shall be subject to re- moval from the board by the Secretary for neglect of duty or
p.000801: malfeasance or for other good cause shown.
p.000801: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000817: ‘‘Foundation’’). The Foundation shall not be an agency or instrumentality of the United States Government.
p.000817: (b) PURPOSE OF FOUNDATION.—The purpose of the Foundation shall be to support the National Institutes of Health
p.000817: in its mission (including collection of funds for pediatric pharmacologic research), and to advance collaboration with
p.000817: biomedical researchers from uni- versities, industry, and nonprofit organizations.
p.000817: (c) CERTAIN ACTIVITIES OF FOUNDATION.—
p.000817: (1) IN GENERAL.—In carrying out subsection (b), the Foun- dation may solicit and accept gifts, grants, and
p.000817: other dona- tions, establish accounts, and invest and expend funds in sup- port of the following activities with
p.000817: respect to the purpose de- scribed in such subsection:
p.000817: (A) A program to provide and administer endowed po- sitions that are associated with the research program of
p.000817: the National Institutes of Health. Such endowments may be expended for the compensation of individuals
p.000817: holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate
p.000817: in supporting the endowed positions.
p.000817: (B) A program to provide and administer fellowships and grants to research personnel in order to work
p.000817: and study in association with the National Institutes of Health. Such fellowships and grants may include
p.000817: stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships
p.000817: shall be selected by the do- nors and the Foundation upon the recommendation of the National Institutes
p.000817: of Health employees in the laboratory where the fellow would serve, and shall be subject to the
p.000817: agreement of the Director of the National Institutes of Health and the Executive Director of the Foundation.
p.000817: (C) A program to collect funds for pediatric pharmaco- logic research and studies.
p.000817: (D) Supplementary programs to provide for—
p.000817: (i) scientists of other countries to serve in research capacities in the United States in association with the
p.000817: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000817:
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p.000817: Sec. 499 PUBLIC HEALTH SERVICE ACT 818
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p.000817: January 30, 2020
p.000817:
p.000817: National Institutes of Health or elsewhere, or opportu- nities for employees of the National Institutes
p.000817: of Health or other public health officials in the United States to serve in such capacities in other countries,
p.000817: or both;
p.000817: (ii) the conduct and support of studies, projects, and research, which may include stipends, travel and
p.000817: other support for personnel in collaboration with na- tional and international non-profit and for-profit orga-
p.000817: nizations;
p.000817: (iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include
p.000817: undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of
p.000817: accreditation of such courses by the Foundation at the State and national level for college or
p.000817: continuing education credits or for degrees;
p.000817: (iv) programs to support and encourage teachers and students of science at all levels of education and
p.000817: programs for the general public which promote the un- derstanding of science;
p.000817: (v) programs for writing, editing, printing, pub- lishing, and vending of books and other materials; and
p.000817: (vi) the conduct of other activities to carry out and support the purpose described in subsection (b).
p.000817: (E) The Cures Acceleration Network described in sec- tion 480.
p.000817: (2) FEES.—The Foundation may assess fees for the provi- sion of professional, administrative and
p.000817: management services by the Foundation in amounts determined reasonable and ap- propriate by the Executive
p.000817: Director.
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p.000819: predecessor of the in- dividual.
p.000819: (D) A member of the Board may continue to serve after the expiration of the term of the member until a suc-
p.000819: cessor is appointed.
p.000819: (4) COMPENSATION.—Members of the Board may not re- ceive compensation for service on the Board. Such
p.000819: members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the
p.000819: duties of the Board, as set forth in the bylaws issued by the Board.
p.000819: (5) MEETINGS AND QUORUM.—A majority of the appointed members of the Board shall constitute a quorum for
p.000819: purposes of conducting the business of the Board.
p.000819: (6) CERTAIN BYLAWS.—
p.000819: (A) In establishing bylaws under this subsection, the Board shall ensure that the following are provided for:
p.000819: (i) Policies for the selection of the officers, employ- ees, agents, and contractors of the Foundation.
p.000819: (ii) Policies, including ethical standards, for the acceptance, solicitation, and disposition of donations
p.000819: and grants to the Foundation and for the disposition of the assets of the Foundation. Policies with
p.000819: respect to ethical standards shall ensure that officers, employ- ees and agents of the Foundation (including
p.000819: members of the Board) avoid encumbrances that would result in a conflict of interest, including a financial
p.000819: conflict of interest or a divided allegiance. Such policies shall in- clude requirements for the provision of
p.000819: information concerning any ownership or controlling interest in en- tities related to the activities of the
p.000819: Foundation by such officers, employees and agents and their spouses and relatives.
p.000819: (iii) Policies for the conduct of the general oper- ations of the Foundation.
p.000819: (iv) Policies for writing, editing, printing, pub- lishing, and vending of books and other materials.
p.000819: (B) In establishing bylaws under this subsection, the Board shall ensure that such bylaws (and activities
p.000819: carried out under the bylaws) do not—
p.000819: (i) reflect unfavorably upon the ability of the Foundation or the National Institutes of Health to
p.000819: carry out its responsibilities or official duties in a fair and objective manner; or
p.000819: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000819:
p.000819:
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p.000819:
p.000821: 821
p.000821: PUBLIC HEALTH SERVICE ACT
p.000821: Sec. 499
p.000821:
p.000821: (ii) compromise, or appear to compromise, the in- tegrity of any governmental agency or program, or any officer
p.000821: or employee involved in such program.
p.000821: (e) INCORPORATION.—The initial members of the Board shall serve as incorporators and shall take whatever actions
p.000821: necessary to incorporate the Foundation.
p.000821: (f) NONPROFIT STATUS.—The Foundation shall be considered to be a corporation under section 501(c) of the Internal
p.000821: Revenue Code of 1986, and shall be subject to the provisions of such section.
p.000821: (g) EXECUTIVE DIRECTOR.—
p.000821: (1) IN GENERAL.—The Foundation shall have an Executive Director who shall be appointed by the Board and shall
p.000821: serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day
p.000821: operations of the Foundation and shall have such specific duties and responsibilities as the Board shall
p.000821: prescribe.
p.000821: (2) COMPENSATION.—The rate of compensation of the Exec- utive Director shall be fixed by the Board.
p.000821: (h) POWERS.—In carrying out subsection (b), the Foundation may—
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p.000821: January 30, 2020
p.000821: (1) operate under the direction of its Board;
p.000821: (2) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.000821: (3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties,
p.000821: and require surety bonds or make other provisions against losses occasioned by acts of such persons;
p.000821: (4) hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of
p.000821: the offi- cers and employees;
p.000821: (5) with the consent of any executive department or inde- pendent agency, use the information, services,
p.000821: staff, and facili- ties of such in carrying out this section;
p.000821: (6) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
p.000821: (7) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an
p.000821: interest under this part;
p.000821: (8) establish a process for the selection of candidates for positions under subsection (c);
p.000821: (9) enter into contracts with public and private organiza- tions for the writing, editing, printing, and
p.000821: publishing of books and other material;
p.000821: (10) take such action as may be necessary to obtain pat- ents and licenses for devices and procedures
p.000821: developed by the Foundation and its employees;
p.000821: (11) solicit, accept, hold, administer, invest, and spend any gift, devise, or bequest of real or personal property
p.000821: made to the Foundation;
p.000821: (12) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion;
p.000821: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000821:
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p.000821:
p.000821: Sec. 499 PUBLIC HEALTH SERVICE ACT 822
p.000821:
p.000821: (13) appoint other groups of advisors as may be deter- mined necessary from time to time to carry out
p.000821: the functions of the Foundation;
p.000821: (14) enter into such other contracts, leases, cooperative agreements, and other transactions as the
p.000821: Executive Director considers appropriate to conduct the activities of the Founda- tion; and
p.000821: (15) exercise other powers as set forth in this section, and such other incidental powers as are necessary to
p.000821: carry out its powers, duties, and functions in accordance with this part.
p.000821: (i) ADMINISTRATIVE CONTROL.—No participant in the program established under this part shall exercise any
p.000821: administrative con- trol over any Federal employee.
p.000821: (j) GENERAL PROVISIONS.—
p.000821: (1) FOUNDATION INTEGRITY.—The members of the Board shall be accountable for the integrity of the
...

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p.000823: January 30, 2020
p.000823: (B) With respect to the financial condition of the Foun- dation, each report under subparagraph (A) shall
p.000823: include the source, and a description of, all gifts or grants to the Foundation of real or personal
p.000823: property, and the source and amount of all gifts or grants to the Foundation of money. Each such report
p.000823: shall include a specification of any restrictions on the purposes for which gifts or grants to the
p.000823: Foundation may be used.
p.000823: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000823: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000823: charge that shall not exceed the cost of providing the copy; and
p.000823: (ii) to the appropriate committees of Congress.
p.000823: (D) The Board shall annually hold a public meeting to summarize the activities of the Foundation and distribute
p.000823: written reports concerning such activities and the scientific results derived from such activities.
p.000823: (5) SERVICE OF FEDERAL EMPLOYEES.—Federal employees may serve on committees advisory to the Foundation
p.000823: and oth- erwise cooperate with and assist the Foundation in carrying out its function, so long as the
p.000823: employees do not direct or con- trol Foundation activities.
p.000823: (6) RELATIONSHIP WITH EXISTING ENTITIES.—The Founda- tion may, pursuant to appropriate agreements, merge with,
p.000823: ac- quire, or use the resources of existing nonprofit private cor- porations with missions similar to the
p.000823: purposes of the Founda- tion, such as the Foundation for Advanced Education in the Sciences.
p.000823: (7) INTELLECTUAL PROPERTY RIGHTS.—The Board shall adopt written standards with respect to the
p.000823: ownership of any intellectual property rights derived from the collaborative ef- forts of the Foundation prior
p.000823: to the commencement of such ef- forts.
p.000823: (8) NATIONAL INSTITUTES OF HEALTH AMENDMENTS OF 1990.—The activities conducted in support of the
p.000823: National Insti- tutes of Health Amendments of 1990 (Public Law 101–613), and the amendments made by such
p.000823: Act, shall not be nullified by the enactment of this section.
p.000823: (9) LIMITATION OF ACTIVITIES.—
p.000823: (A) IN GENERAL.—The Foundation shall exist solely as an entity to work in collaboration with the research pro-
p.000823: grams of the National Institutes of Health. The Founda- tion may not undertake activities (such as the
p.000823: operation of independent laboratories or competing for Federal research funds) that are independent of those of the
p.000823: National Insti- tutes of Health research programs.
p.000823: (B) GIFTS, GRANTS, AND OTHER DONATIONS.—
p.000823: (i) IN GENERAL.—Gifts, grants, and other dona- tions to the Foundation may be designated for pedi- atric
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p.000823: January 30, 2020
p.000823:
p.000823: (ii) OTHER GIFTS.—Other gifts, grants, or dona- tions received by the Foundation and not described in clause (i)
p.000823: may also be used to support such pediatric research and studies.
p.000823: (iii) REPORT.—The recipient of a grant for research and studies shall agree to provide the Director of the
p.000823: National Institutes of Health and the Commissioner of Food and Drugs, at the conclusion of the research and studies—
p.000823: (I) a report describing the results of the re- search and studies; and
p.000823: (II) all data generated in connection with the research and studies.
p.000823: (iv) ACTION BY THE COMMISSIONER OF FOOD AND DRUGS.—The Commissioner of Food and Drugs shall take
p.000823: appropriate action in response to a report re- ceived under clause (iii) in accordance with para-
p.000823: graphs (7) through (12) of section 409I(c), including negotiating with the holders of approved
p.000823: applications for the drugs studied for any labeling changes that the Commissioner determines to be appropriate and
p.000823: re- quests the holders to make.
p.000823: (C) APPLICABILITY.—Subparagraph (A) does not apply to the program described in subsection (c)(1)(C).
p.000823: (10) TRANSFER OF FUNDS.—The Foundation may transfer funds to the National Institutes of Health and the National
p.000823: In- stitutes of Health may accept transfers of funds from the Foun- dation. Any funds transferred under this
p.000823: paragraph shall be subject to all Federal limitations relating to federally-funded research.
p.000823: (k) DUTIES OF THE DIRECTOR.—
p.000823: (1) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL EMPLOYEES.—In the case of any individual who is not
p.000823: an em- ployee of the Federal Government and who serves in associa- tion with the National Institutes of
p.000823: Health, with respect to fi- nancial assistance received from the Foundation, the Founda- tion may not
p.000823: provide the assistance of, or otherwise permit the work at the National Institutes of Health to begin until a
p.000823: memorandum of understanding between the individual and the Director of the National Institutes of Health, or
p.000823: the designee of such Director, has been executed specifying that the indi- vidual shall be subject to
p.000823: such ethical and procedural stand- ards of conduct relating to duties performed at the National In- stitutes of
p.000823: Health, as the Director of the National Institutes of Health determines is appropriate.
p.000823: (2) SUPPORT SERVICES.—The Director of the National Insti- tutes of Health may provide facilities, utilities and
p.000823: support services to the Foundation if it is determined by the Director to be advantageous to the
p.000823: research programs of the National Institutes of Health.
p.000823: (l) FUNDING.—From amounts appropriated to the National In- stitutes of Health, for each fiscal year, the
p.000823: Director of NIH shall transfer not less than $500,000 and not more than $1,250,000 to the Foundation.
p.000823: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000825: 825
p.000825: PUBLIC HEALTH SERVICE ACT
p.000825: Sec. 501
p.000825:
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p.000825: SEC. 501. ø290aa¿ SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION.
p.000825: (a) ESTABLISHMENT.—The Substance Abuse and Mental Health Services Administration (hereafter referred to in this
p.000825: title as the ‘‘Administration’’) is an agency of the Service.
p.000825: (b) CENTERS.—The following Centers are agencies of the Ad- ministration:
p.000825: (1) The Center for Substance Abuse Treatment.
p.000825: (2) The Center for Substance Abuse Prevention.
p.000825: (3) The Center for Mental Health Services.
p.000825: (c) ASSISTANT SECRETARY AND DEPUTY ASSISTANT SEC-
p.000825: RETARY.—
p.000825: (1) ASSISTANT SECRETARY.—The Administration shall be headed by an official to be known as the Assistant
p.000825: Secretary for Mental Health and Substance Use (hereinafter in this title referred to as the ‘‘Assistant
p.000825: Secretary’’) who shall be ap- pointed by the President, by and with the advice and consent of the Senate.
p.000825: (2) DEPUTY ASSISTANT SECRETARY.—The Assistant Sec- retary, with the approval of the Secretary, may appoint
p.000825: a Dep- uty Assistant Secretary and may employ and prescribe the functions of such officers and employees,
p.000825: including attorneys, as are necessary to administer the activities to be carried out through the
p.000825: Administration.
p.000825: (d) AUTHORITIES.—The Secretary, acting through the Assistant Secretary, shall—
p.000825: (1) supervise the functions of the Centers of the Adminis- tration in order to assure that the
p.000825: programs carried out through each such Center receive appropriate and equitable support and that there is
p.000825: cooperation among the Centers in the implementation of such programs;
p.000825: (2) establish and implement, through the respective Cen- ters, a comprehensive program to improve the
p.000825: provision of treatment and related services to individuals with respect to substance use disorders and mental
p.000825: illness and to improve pre- vention services, promote mental health and protect the legal rights of individuals
p.000825: with mental illnesses and individuals with substance use disorders;
p.000825: (3) carry out the administrative and financial manage- ment, policy development and planning, evaluation,
p.000825: knowledge dissemination, and public information functions that are re- quired for the implementation of this
p.000825: title;
p.000825: (4) assure that the Administration conduct and coordinate demonstration projects, evaluations, and service system
p.000825: assess- ments and other activities necessary to improve the avail- ability and quality of treatment,
p.000825: prevention and related serv- ices;
p.000825: (5) support activities that will improve the provision of treatment, prevention and related services, including
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p.000829: services—
p.000829: (i) identify the need for such services, and make an estimate each fiscal year of the funds needed to
p.000829: adequately support the services;
p.000829: (ii) identify needs regarding the coordination of services;
p.000829: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000829: Sec. 501 PUBLIC HEALTH SERVICE ACT 830
p.000829:
p.000829: (iii) encourage the agencies of the Administration to support such services; and
p.000829: (iv) assure that the unique needs of minority women, including Native American, Hispanic, African-
p.000829: American and Asian women, are recognized and ad- dressed within the activities of the Administration; and
p.000829: (C) establish an advisory committee to be known as the Advisory Committee for Women’s Services, which shall be
p.000829: composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees
p.000829: of the Federal Government, to be appointed by the Assist- ant Secretary from among physicians, practitioners,
p.000829: treat- ment providers, and other health professionals, whose clin- ical practice, specialization, or professional
p.000829: expertise in- cludes a significant focus on women’s substance abuse and mental health conditions, that shall—
p.000829: (i) advise the Associate Administrator on appro- priate activities to be undertaken by the agencies of
p.000829: the Administration with respect to women’s substance abuse and mental health services, including services which
p.000829: require a multidisciplinary approach;
p.000829: (ii) collect and review data, including information provided by the Secretary (including the material re-
p.000829: ferred to in paragraph (3)), and report biannually to the Assistant Secretary regarding the extent to which
p.000829: women are represented among senior personnel, and make recommendations regarding improvement in the participation
p.000829: of women in the workforce of the Admin- istration; and
p.000829: (iii) prepare, for inclusion in the biennial report required pursuant to subsection (m), a description of
p.000829: activities of the Committee, including findings made by the Committee regarding—
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p.000831: consultant whose services are obtained under paragraph (1), unless and until the expert or consultant
p.000831: agrees in writing to complete the entire period of assignment or one year, whichever is shorter, unless separated or
p.000831: reassigned for reasons beyond the control of the expert or consultant that are acceptable to the
p.000831: Secretary. If the expert or con- sultant violates the agreement, the money spent by the United States
p.000831: for the expenses specified in subparagraph
p.000831: (A) is recoverable from the expert or consultant as a debt of the United States. The Secretary may waive in
p.000831: whole or in part a right of recovery under this subparagraph.
p.000831: (i) PEER REVIEW GROUPS.—The Assistant Secretary shall, with- out regard to the provisions of title 5, United
p.000831: States Code, gov- erning appointments in the competitive service, and without regard to the provisions of chapter 51
p.000831: and subchapter III of chapter 53 of such title, relating to classification and General Schedule pay rates, establish
p.000831: such peer review groups and program advisory commit- tees as are needed to carry out the requirements
p.000831: of this title and
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000833: 833
p.000833: PUBLIC HEALTH SERVICE ACT
p.000833: Sec. 501
p.000833:
p.000833: appoint and pay members of such groups, except that officers and employees of the United States shall
p.000833: not receive additional com- pensation for services as members of such groups. The Federal Ad- visory Committee Act
p.000833: shall not apply to the duration of a peer re- view group appointed under this subsection.
p.000833: (j) VOLUNTARY SERVICES.—The Assistant Secretary may accept voluntary and uncompensated services.
p.000833: (k) ADMINISTRATION.—The Assistant Secretary shall ensure that programs and activities assigned under
p.000833: this title to the Ad- ministration are fully administered by the respective Centers to which such programs
p.000833: and activities are assigned.
p.000833: (l) STRATEGIC PLAN.—
p.000833: (1) IN GENERAL.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant Secretary shall
p.000833: develop and carry out a strategic plan in accordance with this sub- section for the planning and operation of
p.000833: activities carried out by the Administration, including evidence-based programs.
p.000833: (2) COORDINATION.—In developing and carrying out the strategic plan under this subsection, the Assistant
p.000833: Secretary shall take into consideration the findings and recommenda- tions of the Assistant Secretary for
p.000833: Planning and Evaluation under section 6021(d) of the Helping Families in Mental Health Crisis
p.000833: Reform Act of 2016 and the report of the Inter- departmental Serious Mental Illness Coordinating
p.000833: Committee under section 6031 of such Act.
p.000833: (3) PUBLICATION OF PLAN.—Not later than September 30, 2018, and every 4 years thereafter, the Assistant
p.000833: Secretary shall—
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p.000839:
p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
p.000839: members to be appointed by the Secretary under paragraph (3).
p.000839: (2) EX OFFICIO MEMBERS.—The ex officio members of an advisory council shall consist of—
p.000839: (A) the Secretary;
p.000839: (B) the Assistant Secretary;
p.000839: (C) the Director of the Center for which the council is established;
p.000839: (D) the Under Secretary for Health of the Department of Veterans Affairs;
p.000839: (E) the Assistant Secretary for Defense for Health Af- fairs (or the designates of such officers);
p.000839: (F) the Chief Medical Officer, appointed under section 501(g);
p.000839: (G) the Director of the National Institute of Mental Health for the advisory councils appointed
p.000839: under sub- sections (a)(1)(A) and (a)(1)(D);
p.000839: (H) the Director of the National Institute on Drug Abuse for the advisory councils appointed under
p.000839: sub- sections (a)(1)(A), (a)(1)(B), and (a)(1)(C);
p.000839: (I) the Director of the National Institute on Alcohol Abuse and Alcoholism for the advisory councils
p.000839: appointed under subsections (a)(1)(A), (a)(1)(B), and (a)(1)(C); and
p.000839: (J) such additional officers or employees of the United States as the Secretary determines necessary for the advi- sory
p.000839: council to effectively carry out its functions.
p.000839: (3) APPOINTED MEMBERS.—Individuals shall be appointed to an advisory council under paragraph (1) as follows:
p.000839: (A) Nine of the members shall be appointed by the Secretary from among the leading representatives of
p.000839: the health disciplines (including public health and behavioral and social sciences) relevant to the activities of
p.000839: the Admin- istration or Center for which the advisory council is estab- lished.
p.000839: (B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders
p.000839: in fields of public policy, public relations, law, health policy economics, or management.
p.000839: (C) Not less than half of the members of the advisory council appointed under subsection (a)(1)(D)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree in psychology; or
p.000839: (III) have an advanced degree in nursing or social work from an accredited graduate school or be a certified
p.000839: physician assistant; and
p.000839: (ii) shall specialize in the mental health field.
p.000839: (D) Not less than half of the members of the advisory councils appointed under subsections (a)(1)(B) and
p.000839: (a)(1)(C)—
p.000839: (i) shall—
p.000839: (I) have a medical degree;
p.000839: (II) have a doctoral degree; or
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000841: 841
p.000841: PUBLIC HEALTH SERVICE ACT
p.000841: Sec. 502
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p.000841: January 30, 2020
p.000841: (III) have an advanced degree in nursing, public health, behavioral or social sciences, or so- cial
p.000841: work from an accredited graduate school or be a certified physician assistant; and
p.000841: (ii) shall have experience in the provision of sub- stance use disorder services or the development and
p.000841: implementation of programs to prevent substance mis- use.
p.000841: (4) COMPENSATION.—Members of an advisory council who are officers or employees of the United States shall not
p.000841: receive any compensation for service on the advisory council. The re- maining members of an advisory council
p.000841: shall receive, for each day (including travel time) they are engaged in the perform- ance of the functions
p.000841: of the advisory council, compensation at rates not to exceed the daily equivalent to the annual rate in
p.000841: effect for grade GS–18 of the General Schedule.
p.000841: (c) TERMS OF OFFICE.—
p.000841: (1) IN GENERAL.—The term of office of a member of an ad- visory council appointed under subsection (b) shall be 4
p.000841: years, except that any member appointed to fill a vacancy for an un- expired term shall serve for the remainder
p.000841: of such term. The Secretary shall make appointments to an advisory council in such a manner as to ensure
p.000841: that the terms of the members not all expire in the same year. A member of an advisory council may serve
p.000841: after the expiration of such member’s term until a successor has been appointed and taken office.
p.000841: (2) REAPPOINTMENTS.—A member who has been appointed to an advisory council for a term of 4 years may not
p.000841: be re- appointed to an advisory council during the 2-year period be- ginning on the date on which such 4-year
p.000841: term expired.
p.000841: (3) TIME FOR APPOINTMENT.—If a vacancy occurs in an ad- visory council among the members under subsection (b),
p.000841: the Secretary shall make an appointment to fill such vacancy with- in 90 days from the date the vacancy occurs.
p.000841: (d) CHAIR.—The Secretary shall select a member of an advisory council to serve as the chair of the council.
p.000841: The Secretary may so select an individual from among the appointed members, or may select the Assistant
...

p.000843: the United States. In the case of any such peer review group that is reviewing a grant, cooperative agreement,
p.000843: or contract re- lated to mental illness treatment, not less than half of the mem- bers of such peer
p.000843: review group shall be licensed and experienced professionals in the prevention, diagnosis, or treatment of, or
p.000843: recov- ery from, mental illness or co-occurring mental illness and sub- stance use disorders and have a
p.000843: medical degree, a doctoral degree in psychology, or an advanced degree in nursing or social work from an
p.000843: accredited program, and the Secretary, in consultation with the Assistant Secretary, shall, to the extent
p.000843: possible, ensure such peer review groups include broad geographic representation, including both urban and
p.000843: rural representatives.
p.000843: (c) ADVISORY COUNCIL REVIEW.—If the direct cost of a grant or cooperative agreement (described in subsection (a))
p.000843: exceeds the simple acquisition threshold as defined by section 4(11) of the Of- fice of Federal
p.000843: Procurement Policy Act, the Secretary may make such a grant or cooperative agreement only if such grant or
p.000843: cooper- ative agreement is recommended—
p.000843: (1) after peer review required under subsection (a); and
p.000843: (2) by the appropriate advisory council.
p.000843: (d) CONDITIONS.—The Secretary may establish limited excep- tions to the limitations contained in this
p.000843: section regarding partici- pation of Federal employees and advisory council approval. The cir- cumstances under
p.000843: which the Secretary may make such an excep- tion shall be made public.
p.000843: SEC. 505. ø290aa–4¿ CENTER FOR BEHAVIORAL HEALTH STATISTICS AND QUALITY. 2
p.000843: (a) IN GENERAL.—The Assistant Secretary shall maintain with- in the Administration a Center for Behavioral
p.000843: Health Statistics
p.000843:
p.000843: 1 Section 504 appears according to the probable intent of the Congress. Section 3401(b) of Pub- lic Law 106–310 (114
p.000843: Stat. 1218) provides that the section ‘‘is amended as follows:’’. No amend- atory instructions were then given, but a
p.000843: substitute text was provided. The amendment probably should have instructed that section 504 ‘‘is amended to read as
p.000843: follows:’’.
p.000843: 2 Section 502 of Public Law 104–237 (110 Stat. 3112) provides as follows:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: Continued
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
p.000843:
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p.000843:
p.000843: Sec. 505 PUBLIC HEALTH SERVICE ACT 844
p.000843:
p.000843: and Quality (in this section referred to as the ‘‘Center’’). The Cen- ter shall be headed by a Director (in
p.000843: this section referred to as the ‘‘Director’’) appointed by the Secretary from among individuals with extensive
p.000843: experience and academic qualifications in research and analysis in behavioral health care or related fields. (b)
p.000843: The Director shall—
...

p.000907: (4) SUBSTANCE USE DISORDER SERVICES.—The term ‘‘sub- stance use disorder services’’ has the meaning
p.000907: given the term ‘‘substance abuse services’’ in section 330(h)(5)(C).
p.000907: SEC. 535. ø290cc–35¿ FUNDING.
p.000907: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there is authorized to
p.000907: be appropriated
p.000907: $64,635,000 for each of fiscal years 2018 through 2022.
p.000907: (b) EFFECT OF INSUFFICIENT APPROPRIATIONS FOR MINIMUM ALLOTMENTS.—
p.000907: (1) IN GENERAL.—If the amounts made available under subsection (a) for a fiscal year are insufficient
p.000907: for providing each State with an allotment under section 521 of not less than the applicable amount under section
p.000907: 524(a)(1), the Secretary shall, from such amounts as are made available under such subsection, make grants
p.000907: to the States for providing to eligible homeless individuals the services specified in section 522(b).
p.000907: (2) RULE OF CONSTRUCTION.—Paragraph (1) may not be construed to require the Secretary to make a grant under such
p.000907: paragraph to each State.
p.000907: PART D—MISCELLANEOUS PROVISIONS RELATING TO SUBSTANCE ABUSE AND MENTAL HEALTH
p.000907: SEC. 541. ø290dd¿ SUBSTANCE ABUSE AMONG GOVERNMENT AND OTHER EMPLOYEES.
p.000907: (a) PROGRAMS AND SERVICES.—
p.000907: (1) DEVELOPMENT.—The Secretary, acting through the As- sistant Secretary for Mental Health and Substance
p.000907: Use, shall be responsible for fostering substance abuse prevention and treatment programs and services in
p.000907: State and local govern- ments and in private industry.
p.000907: (2) MODEL PROGRAMS.—
p.000907: (A) IN GENERAL.—Consistent with the responsibilities described in paragraph (1), the Secretary, acting
p.000907: through the Assistant Secretary for Mental Health and Substance Use, shall develop a variety of model programs
p.000907: suitable for replication on a cost-effective basis in different types of business concerns and State and
p.000907: local governmental enti- ties.
p.000907:
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p.000907: January 30, 2020
p.000907: (B) DISSEMINATION OF INFORMATION.—The Secretary, acting through the Assistant Secretary for Mental Health
p.000907: and Substance Use, shall disseminate information and ma- terials relative to such model programs to the State agen-
p.000907: cies responsible for the administration of substance abuse prevention, treatment, and rehabilitation
p.000907: activities and shall, to the extent feasible provide technical assistance to such agencies as requested.
p.000907: (b) DEPRIVATION OF EMPLOYMENT.—
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p.001005: (1) the yearly and cumulative maximum amounts that may be borrowed by the student;
p.001005: (2) the terms under which repayment of the loan will begin;
p.001005: (3) the maximum number of years in which the loan must be repaid;
p.001005: (4) the interest rate that will be paid by the borrower and the minimum amount of the required monthly payment;
p.001005: (5) the amount of any other fees charged to the borrower by the lender;
p.001005: (6) any options the borrower may have for deferral, can- cellation, prepayment, consolidation, or other
p.001005: refinancing of the loan;
p.001005: (7) a definition of default on the loan and a specification of the consequences which will result to
p.001005: the borrower if the borrower defaults, including a description of any arrangements which may be made with credit
p.001005: bureau organizations;
p.001005: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001007: PUBLIC HEALTH SERVICE ACT
p.001007: Sec. 728
p.001007:
p.001007: (8) to the extent practicable, the effect of accepting the loan on the eligibility of the borrower for
p.001007: other forms of stu- dent assistance; and
p.001007: (9) a description of the actions that may be taken by the Federal Government to collect the loan, including
p.001007: a description of the type of information concerning the borrower that the Federal Government may disclose to
p.001007: (A) officers, employees, or agents of the Department of Health and Human Services, (B) officers, employees,
p.001007: or agents of schools with which the Sec- retary has an agreement under this subpart, or (C) any other
p.001007: person involved in the collection of a loan under this subpart.
p.001007: (b) STATEMENT REGARDING LOAN.—Each school shall, imme- diately prior to the graduation from such school
p.001007: of a student who receives a loan under this subpart after June 30, 1986, provide such student with a
p.001007: statement specifying—
p.001007: (1) each amount borrowed by the student under this sub- part;
p.001007: (2) the total amount borrowed by the student under this subpart; and
p.001007: (3) a schedule for the repayment of the amounts borrowed under this subpart, including the number, amount, and
p.001007: fre- quency of payments to be made.
p.001007: SEC. 727. ø292w¿ PROCEDURES FOR APPEAL OF TERMINATION OF AGREEMENTS.
p.001007: In any case in which the Secretary intends to terminate an agreement with a school under this subpart,
p.001007: the Secretary shall provide the school with a written notice specifying such intention and stating that the
p.001007: school may request a formal hearing with re- spect to such termination. If the school requests such a hearing
p.001007: within 30 days after the receipt of such notice, the Secretary shall provide such school with a hearing conducted by an
p.001007: administrative law judge.
p.001007: SEC. 728. ø292x¿ DISTRIBUTION OF ASSETS FROM LOAN FUNDS.
p.001007: (a) DISTRIBUTION AFTER TERMINATION OF FUND.—If a school terminates a loan fund established under an
...

p.001027: (d) APPLICATION.—An eligible entity desiring a grant under this section shall submit to the Secretary an
p.001027: application at such time, in such manner, and containing such information as the Sec- retary may require.
p.001027: (e) DURATION OF AWARD.—The period during which payments are made to an entity from an award of a grant or
p.001027: contract under subsection (a) shall be 5 years. The provision of such payments shall be subject to annual
p.001027: approval by the Secretary and subject to the availability of appropriations for the fiscal year involved to
p.001027: make the payments.
p.001027: (f) AUTHORIZATIONS OF APPROPRIATIONS.—For the purpose of carrying out subsections (a) and (b), there is
p.001027: authorized to be ap- propriated $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of
p.001027: fiscal years 2011 through 2015.
p.001027: (g) CARRYOVER FUNDS.—An entity that receives an award under this section may carry over funds from
p.001027: 1 fiscal year to an- other without obtaining approval from the Secretary. In no case may any funds be
p.001027: carried over pursuant to the preceding sentence for more than 3 years.
p.001027: SEC. 749. ø293l¿ ADVISORY COMMITTEE ON TRAINING IN PRIMARY CARE MEDICINE AND DENTISTRY.
p.001027: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001027: Training in Primary Care Medicine and Dentistry (in this section referred to as the ‘‘Advisory Committee’’).
p.001027: (b) COMPOSITION.—
p.001027: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001027: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001027: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 8, the Secretary shall
p.001027: appoint the members of the Advisory Committee from among individuals who are health professionals. In
p.001027: making such appointments, the Secretary shall ensure a fair balance between the health professions, that at
p.001027: least 75 percent of the members of the Ad- visory Committee are health professionals, a broad geographic representation
p.001027: of members and a balance between urban and rural members. Members shall be appointed based on their
p.001027: competence, interest, and knowledge of the mission of the pro- fession involved.
p.001027: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001027: the Sec-
p.001027:
p.001027:
p.001027:
p.001027:
p.001027:
p.001027: January 30, 2020
p.001027: 8 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted
p.001027: July 1, 1944. Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which
p.001027: added section 748. That Act is Public Law 105–392, enacted November 13, 1998. (Section 102(4) of that Public Law (112
p.001027: Stat. 3539) added section 748.)
p.001027: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001029: Sec. 749A PUBLIC HEALTH SERVICE ACT 1030
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p.001029: such a meeting, the Advisory Committee shall prepare and make available a summary of the meeting and
p.001029: any actions taken by the Committee based upon the meeting.
p.001029: (f) COMPENSATION AND EXPENSES.—
p.001029: (1) COMPENSATION.—Each member of the Advisory Com- mittee shall be compensated at a rate equal to the daily
p.001029: equiv- alent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315
p.001029: of title 5, United States Code, for each day (including travel time) during which such member is engaged in the
p.001029: performance of the duties of the Committee.
p.001029: (2) EXPENSES.—The members of the Advisory Committee shall be allowed travel expenses, including per diem in lieu
p.001029: of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title
p.001029: 5, United States Code, while away from their homes or regular places of business in the performance of
p.001029: services for the Committee.
p.001029: (g) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section only to the
p.001029: extent that the provisions of such Act do not conflict with the requirements of this section.
p.001029: SEC. 749A. ø293l–1¿ TEACHING HEALTH CENTERS DEVELOPMENT GRANTS.
p.001029: (a) PROGRAM AUTHORIZED.—The Secretary may award grants under this section to teaching health centers for the
p.001029: purpose of es- tablishing new accredited or expanded primary care residency pro- grams.
p.001029: (b) AMOUNT AND DURATION.—Grants awarded under this sec- tion shall be for a term of not more than 3 years and
p.001029: the maximum award may not be more than $500,000.
p.001029: (c) USE OF FUNDS.—Amounts provided under a grant under this section shall be used to cover the costs of—
p.001029: (1) establishing or expanding a primary care residency training program described in subsection (a),
p.001029: including costs associated with—
p.001029: (A) curriculum development;
p.001029: (B) recruitment, training and retention of residents and faculty:
p.001029: (C) accreditation by the Accreditation Council for Graduate Medical Education (ACGME), the American Den-
p.001029: tal Association (ADA), or the American Osteopathic Asso- ciation (AOA); and
p.001029: (D) faculty salaries during the development phase; and
p.001029: (2) technical assistance provided by an eligible entity.
p.001029: (d) APPLICATION.—A teaching health center seeking a grant under this section shall submit an application
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p.001047: (1) providing graduate students support for experiential training (internship or field placement);
p.001047: (2) recruiting students interested in behavioral health practice;
p.001047: (3) recruiting students in accordance with subsection (b)(1);
p.001047: (4) developing and implementing interprofessional training and integration within primary care;
p.001047: (5) developing and implementing accredited field place- ments and internships; and
p.001047: (6) collecting data on the number of students trained in be- havioral health care and the number of available
p.001047: accredited in- ternships and field placements.
p.001047: (f) AUTHORIZATION OF APPROPRIATIONS.—For each of fiscal years 2019 through 2023, there are
p.001047: authorized to be appropriated to carry out this section $50,000,000, to be allocated as follows:
p.001047: (1) For grants described in subsection (a)(1), $15,000,000.
p.001047: (2) For grants described in subsection (a)(2), $15,000,000.
p.001047: (3) For grants described in subsection (a)(3), $10,000,000.
p.001047: (4) For grants described in subsection (a)(4), $10,000,000.
p.001047: SEC. 757. ø294f¿ ADVISORY COMMITTEE ON INTERDISCIPLINARY, COM- MUNITY-BASED LINKAGES.
p.001047: (a) ESTABLISHMENT.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on
p.001047: Interdiscipli- nary, Community-Based Linkages (in this section referred to as the ‘‘Advisory Committee’’).
p.001047: (b) COMPOSITION.—
p.001047: (1) IN GENERAL.—The Secretary shall determine the appro- priate number of individuals to serve on the Advisory
p.001047: Com- mittee. Such individuals shall not be officers or employees of the Federal Government.
p.001047: (2) APPOINTMENT.—Not later than 90 days after the date of enactment of this Act 12, the Secretary
p.001047: shall appoint the members of the Advisory Committee from among individuals who are health professionals
p.001047: from schools of the types de- scribed in sections 751(b)(1)(A), 753(b), and 755(b). In making such
p.001047: appointments, the Secretary shall ensure a fair balance between the health professions, that at least 75 percent
p.001047: of the members of the Advisory Committee are health professionals, a broad geographic representation of
p.001047: members and a balance between urban and rural members. Members shall be ap- pointed based on their
p.001047: competence, interest, and knowledge of the mission of the profession involved.
p.001047: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Committee under paragraph (2),
p.001047: the Sec- retary shall ensure the adequate representation of women and minorities.
p.001047: (c) TERMS.—
p.001047:
p.001047:
p.001047:
p.001047:
p.001047:
p.001047: January 30, 2020
p.001047: 12 So in law. The reference to ‘‘this Act’’ means the Public Health Service Act, which was en- acted July 1, 1944.
p.001047: Probably should be a reference to the Health Professions Education Partner- ships Act of 1998, which added section 756.
p.001047: That Act is Public Law 105–392, enacted November 13, 1998. (Section 103 of that Public Law (112 Stat. 3541) added
p.001047: section 756.)
p.001047: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001047:
p.001047:
p.001047:
p.001047:
p.001047:
p.001047:
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p.001049: Stat. 3541).
p.001049: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001049: Sec. 759 PUBLIC HEALTH SERVICE ACT 1050
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p.001049: (1) COMPENSATION.—Each member of the Advisory Com- mittee shall be compensated at a rate equal to the daily
p.001049: equiv- alent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315
p.001049: of title 5, United States Code, for each day (including travel time) during which such member is engaged in the
p.001049: performance of the duties of the Committee.
p.001049: (2) EXPENSES.—The members of the Advisory Committee shall be allowed travel expenses, including per diem in lieu
p.001049: of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title
p.001049: 5, United States Code, while away from their homes or regular places of business in the performance of
p.001049: services for the Committee.
p.001049: (g) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section only to the
p.001049: extent that the provisions of such Act do not conflict with the requirements of this section.
p.001049: øNote: Section 758 was repealed by section 501(b)(2) of Public Law 113–4; enacted March 7, 2013, 127 Stat. 54.¿
p.001049: SEC. 759. ø294i¿ PROGRAM FOR EDUCATION AND TRAINING IN PAIN CARE.
p.001049: (a) IN GENERAL.—The Secretary may make awards of grants, cooperative agreements, and contracts to
p.001049: health professions schools, hospices, tribal health programs (as defined in section 4 of the Indian Health Care
p.001049: Improvement Act), and other public and nonprofit private entities for the development and implementation of
p.001049: programs to provide education and training to health care pro- fessionals in pain care.
p.001049: (b) CERTAIN TOPICS.—An entity receiving an award under this section shall develop a comprehensive education and
p.001049: training plan that includes information and education on—
p.001049: (1) recognized means for assessing, diagnosing, preventing, treating, and managing pain and related signs and symptoms,
p.001049: including non-addictive medical products and non-pharmaco- logic treatments and the medically appropriate
p.001049: use of con- trolled substances;
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p.001069: (f) BREACH.—
p.001069: (1) LIQUIDATED DAMAGES FORMULA.—The Secretary may establish a liquidated damages formula to be used in the event
p.001069: of a breach of an agreement entered into under subsection (a).
p.001069: (2) LIMITATION.—The failure by an individual to complete the full period of service obligated pursuant to
p.001069: such an agree- ment, taken alone, shall not constitute a breach of the agree- ment, so long as the
p.001069: individual completed in good faith the years of service for which payments were made to the indi- vidual
p.001069: under this section.
p.001069: (g) ADDITIONAL CRITERIA.—The Secretary—
p.001069: (1) may establish such criteria and rules to carry out this section as the Secretary determines are needed
p.001069: and in addition to the criteria and rules specified in this section; and
p.001069: (2) shall give notice to the committees specified in sub- section (h) of any criteria and rules so
p.001069: established.
p.001069: (h) REPORT TO CONGRESS.—Not later than 5 years after the date of enactment of this section, and every
p.001069: other year thereafter, the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of
p.001069: the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate a
p.001069: report on—
p.001069: (1) the number and location of borrowers who have quali- fied for loan repayments under this section; and
p.001069: (2) the impact of this section on the availability of sub- stance use disorder treatment employees
p.001069: nationally and in shortage areas and counties described in subsection (d).
p.001069: (i) DEFINITION.—In this section:
p.001069: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.001069: Indian Self- Determination and Education Assistance Act.
p.001069: (2) The term ‘‘municipality’’ means a city, town, or other public body created by or pursuant to State
p.001069: law, or an Indian tribe.
p.001069: (3) The term ‘‘substance use disorder treatment employ- ment’’ means full-time employment (including a
p.001069: fellowship)—
p.001069: (A) where the primary intent and function of the posi- tion is the direct treatment or recovery support of patients
p.001069: with or in recovery from a substance use disorder, includ- ing master’s level social workers, psychologists,
p.001069: counselors, marriage and family therapists, psychiatric mental health practitioners, occupational therapists,
p.001069: psychology doctoral interns, and behavioral health paraprofessionals and phy- sicians, physician assistants, and
p.001069: nurses, who are licensed
p.001069: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001069:
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p.001069:
p.001071: 1071
p.001071: PUBLIC HEALTH SERVICE ACT
p.001071: Sec. 791
p.001071:
p.001071: or certified in accordance with applicable State and Fed- eral laws; and
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p.001077: Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the
p.001077: payments. This paragraph may not be construed as limiting the number of awards under the program involved that
p.001077: may be made to the entity.
p.001077: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001077: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001077: title that relates to the period during which payments may be made under the award.
p.001077: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001077:
p.001077:
p.001077:
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p.001077:
p.001077: Sec. 799A PUBLIC HEALTH SERVICE ACT 1078
p.001077:
p.001077: (f) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001077: (1) IN GENERAL.—Each application for a grant under this title, except any scholarship or loan program,
p.001077: including those under sections 23 701, 721, or 723, shall be submitted to a peer review group for an evaluation
p.001077: of the merits of the proposals made in the application. The Secretary may not approve such an
p.001077: application unless a peer review group has recommended the application for approval.
p.001077: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001077: are not officers or employees of the Federal Government. In pro- viding for the establishment of peer
p.001077: review groups and proce- dures, the Secretary shall ensure sex, racial, ethnic, and geo- graphic balance
p.001077: among the membership of such groups.
p.001077: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001077: Administrator of the Health Resources and Services Administration.
p.001077: (g) PREFERENCE OR PRIORITY CONSIDERATIONS.—In considering a preference or priority for funding which is
p.001077: based on outcome measures for an eligible entity under this title, the Secretary may also consider the
p.001077: future ability of the eligible entity to meet the outcome preference or priority through improvements in
p.001077: the eligi- ble entity’s program design.
p.001077: (h) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001077: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001077: analysis activities under section 761; and
p.001077: (2) discipline-specific workforce information and analytical activities are carried out as part of—
p.001077: (A) the community-based linkage program under part D; and
p.001077: (B) the health workforce development program under subpart 2 of part E.
p.001077: (i) OSTEOPATHIC SCHOOLS.—For purposes of this title, any ref- erence to—
p.001077: (1) medical schools shall include osteopathic medical schools; and
p.001077: (2) medical students shall include osteopathic medical stu- dents.
p.001077: SEC. 799A. ø295o–2¿ TECHNICAL ASSISTANCE.
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p.001087: Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the
p.001087: payments. This paragraph may not be construed as limiting the number of awards under the program involved that
p.001087: may be made to the entity.
p.001087: (2) LIMITATION.—In the case of an award to an entity of a grant, cooperative agreement, or contract under
p.001087: this title, paragraph (1) shall apply only to the extent not inconsistent with any other provision of this
p.001087: title that relates to the period during which payments may be made under the award.
p.001087: (e) PEER REVIEW REGARDING CERTAIN PROGRAMS.—
p.001087: (1) IN GENERAL.—Each application for a grant under this title, except advanced nurse traineeship grants
p.001087: under section 811(a)(2), shall be submitted to a peer review group for an evaluation of the merits of
p.001087: the proposals made in the applica- tion. The Secretary may not approve such an application un- less a
p.001087: peer review group has recommended the application for approval.
p.001087: (2) COMPOSITION.—Each peer review group under this sub- section shall be composed principally of individuals who
p.001087: are
p.001087: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001087:
p.001087:
p.001087:
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p.001087:
p.001087: Sec. 807 PUBLIC HEALTH SERVICE ACT 1088
p.001087:
p.001087: not officers or employees of the Federal Government. In pro- viding for the establishment of peer review
p.001087: groups and proce- dures, the Secretary shall, except as otherwise provided, en- sure sex, racial, ethnic,
p.001087: and geographic representation among the membership of such groups.
p.001087: (3) ADMINISTRATION.—This subsection shall be carried out by the Secretary acting through the
p.001087: Administrator of the Health Resources and Services Administration.
p.001087: (f) ANALYTIC ACTIVITIES.—The Secretary shall ensure that—
p.001087: (1) cross-cutting workforce analytical activities are carried out as part of the workforce information and
p.001087: analysis activities under this title; and
p.001087: (2) discipline-specific workforce information is developed and analytical activities are carried out as part of—
p.001087: (A) the advanced education nursing activities under part B;
p.001087: (B) the workforce diversity activities under part C;
p.001087: and
p.001087: (C) basic nursing education and practice activities
p.001087:
p.001087:
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p.001087: January 30, 2020
p.001087: under part D.
p.001087: (g) STATE AND REGIONAL PRIORITIES.—Activities under grants or contracts under this title shall, to the
...

p.001107: (f) PRIORITY.—For the purposes of this section and section 846A, funding priority will be awarded to
p.001107: School of Nursing Stu- dent Loans that support doctoral nursing students or Individual Student Loan
p.001107: Repayment that support doctoral nursing students.
p.001107: (g) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.001107: sums as may be necessary for each of fiscal years 2010 through 2014.
p.001107: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001107:
p.001107:
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p.001107: Sec. 851 PUBLIC HEALTH SERVICE ACT 1108
p.001107:
p.001107: PART F—NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE
p.001107:
p.001107: SEC. 851. ø297t¿ NATIONAL ADVISORY COUNCIL ON NURSE EDUCATION AND PRACTICE.
p.001107: (a) ESTABLISHMENT.—The Secretary shall establish an advisory council to be known as the National Advisory
p.001107: Council on Nurse Education and Practice (in this section referred to as the ‘‘Advisory Council’’).
p.001107: (b) COMPOSITION.—
p.001107: (1) IN GENERAL.—The Advisory Council shall be composed
p.001107:
p.001107: of—
p.001107:
p.001107: (A) not less than 21, nor more than 23 individuals, who are not officers or employees of the Federal
p.001107: Govern- ment, appointed by the Secretary without regard to the Federal civil service laws, of which—
p.001107: (i) 2 shall be selected from full-time students en- rolled in schools of nursing;
p.001107: (ii) 2 shall be selected from the general public;
p.001107: (iii) 2 shall be selected from practicing profes- sional nurses; and
p.001107: (iv) 9 shall be selected from among the leading au- thorities in the various fields of nursing, higher, sec-
p.001107: ondary education, and associate degree schools of nursing, and from representatives of advanced edu-
p.001107: cation nursing groups (such as nurse practitioners, nurse midwives, and nurse anesthetists), hospitals, and
p.001107: other institutions and organizations which provide nursing services; and
p.001107: (B) the Secretary (or the delegate of the Secretary (who shall be an ex officio member and shall serve as the
p.001107: Chairperson)).
p.001107: (2) APPOINTMENT.—Not later than 90 days after the date
p.001107: of enactment of this Act 12, the Secretary shall appoint the members of the Advisory Council and each such
p.001107: member shall serve a 4 year term. In making such appointments, the Sec- retary shall ensure a fair balance
p.001107: between the nursing profes- sions, a broad geographic representation of members and a bal- ance between urban and rural
p.001107: members. Members shall be ap- pointed based on their competence, interest, and knowledge of the mission of the
p.001107: profession involved. A majority of the mem- bers shall be nurses.
p.001107: (3) MINORITY REPRESENTATION.—In appointing the mem- bers of the Advisory Council under paragraph (1),
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p.001109: (e) MEETINGS AND DOCUMENTS.—
p.001109: (1) MEETINGS.—The Advisory Council shall meet not less than 2 times each year. Such meetings shall be
p.001109: held jointly with other related entities established under this title where appropriate.
p.001109: (2) DOCUMENTS.—Not later than 14 days prior to the con- vening of a meeting under paragraph (1), the Advisory
p.001109: Council shall prepare and make available an agenda of the matters to be considered by the Advisory Council at such
p.001109: meeting. At any such meeting, the Advisory Council shall distribute materials with respect to the issues to be
p.001109: addressed at the meeting. Not later than 30 days after the adjourning of such a meeting, the Advisory Council shall
p.001109: prepare and make available a summary of the meeting and any actions taken by the Council based upon the
p.001109: meeting.
p.001109: (f) COMPENSATION AND EXPENSES.—
p.001109: (1) COMPENSATION.—Each member of the Advisory Council shall be compensated at a rate equal to the daily equivalent of
p.001109: the annual rate of basic pay prescribed for level IV of the Exec- utive Schedule under section 5315 of title 5,
p.001109: United States Code, for each day (including travel time) during which such member is engaged in the
p.001109: performance of the duties of the Council. All members of the Council who are officers or em- ployees of
p.001109: the United States shall serve without compensation in addition to that received for their services as officers or em-
p.001109: ployees of the United States.
p.001109: (2) EXPENSES.—The members of the Advisory Council shall be allowed travel expenses, including per diem in lieu
p.001109: of sub- sistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5,
p.001109: United States Code, while away from their homes or regular places of business in the per- formance of services for the
p.001109: Council.
p.001109: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001109:
p.001109:
p.001109:
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p.001109:
p.001109: Sec. 861 PUBLIC HEALTH SERVICE ACT 1110
p.001109:
p.001109: (g) FUNDING.—Amounts appropriated under this title may be utilized by the Secretary to support the nurse
p.001109: education and prac- tice activities of the Council.
p.001109: (h) FACA.—The Federal Advisory Committee Act shall apply to the Advisory Committee under this section
p.001109: only to the extent that the provisions of such Act do not conflict with the require- ments of this
p.001109: section.
p.001109: PART G—PUBLIC SERVICE ANNOUNCEMENTS
p.001109: SEC. 861. ø297w¿ PUBLIC SERVICE ANNOUNCEMENTS.
p.001109: (a) IN GENERAL.—The Secretary shall develop and issue public service announcements that advertise and promote the
p.001109: nursing profession, highlight the advantages and rewards of nursing, and encourage individuals to enter the
p.001109: nursing profession.
p.001109: (b) METHOD.—The public service announcements described in subsection (a) shall be broadcast through
p.001109: appropriate media out- lets, including television or radio, in a manner intended to reach as wide and
p.001109: diverse an audience as possible.
...

p.001129: regulations issued pursuant to section 264(c)(1) of the Health Insurance Port- ability and Accountability Act
p.001129: of 1996 (42 U.S.C. 1320d-2 note) for a single act or omission.
p.001129: (4) EQUITABLE RELIEF.—
p.001129: (A) IN GENERAL.—Without limiting remedies available to other parties, a civil action may be brought by any
p.001129: ag- grieved individual to enjoin any act or practice that vio- lates subsection (e) and to obtain other
p.001129: appropriate equi- table relief (including reinstatement, back pay, and res- toration of benefits) to redress
p.001129: such violation.
p.001129: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001129:
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p.001131: 1131
p.001131: PUBLIC HEALTH SERVICE ACT
p.001131: Sec. 922
p.001131:
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p.001131: January 30, 2020
p.001131: (B) AGAINST STATE EMPLOYEES.—An entity that is a State or an agency of a State government may not
p.001131: assert the privilege described in subsection (a) unless before the time of the assertion, the entity or, in the
p.001131: case of and with respect to an agency, the State has consented to be subject to an action described in
p.001131: subparagraph (A), and that con- sent has remained in effect.
p.001131: (g) RULE OF CONSTRUCTION.—Nothing in this section shall be construed—
p.001131: (1) to limit the application of other Federal, State, or local laws that provide greater privilege or
p.001131: confidentiality protec- tions than the privilege and confidentiality protections pro- vided for in this
p.001131: section;
p.001131: (2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to
p.001131: information that is not privi- leged or confidential under this section;
p.001131: (3) except as provided in subsection (i), to alter or affect the implementation of any provision of the
p.001131: HIPAA confiden- tiality regulations or section 1176 of the Social Security Act (or regulations promulgated under such
p.001131: section);
p.001131: (4) to limit the authority of any provider, patient safety or- ganization, or other entity to enter into a
p.001131: contract requiring greater confidentiality or delegating authority to make a disclo- sure or use in accordance with
p.001131: this section;
p.001131: (5) as preempting or otherwise affecting any State law re- quiring a provider to report information that is not
p.001131: patient safety work product; or
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p.001151: Council for Healthcare Re- search and Quality.
p.001151: (b) DUTIES.—
p.001151: (1) IN GENERAL.—The Advisory Council shall advise the Secretary and the Director with respect to
p.001151: activities proposed or undertaken to carry out the mission of the Agency under section 901(b).
p.001151: (2) CERTAIN RECOMMENDATIONS.—Activities of the Advi- sory Council under paragraph (1) shall include
p.001151: making rec- ommendations to the Director regarding—
p.001151: (A) priorities regarding health care research, espe- cially studies related to quality, outcomes, cost and the
p.001151: uti- lization of, and access to, health care services;
p.001151: (B) the field of health care research and related dis- ciplines, especially issues related to training
p.001151: needs, and dissemination of information pertaining to health care quality; and
p.001151: (C) the appropriate role of the Agency in each of these areas in light of private sector activity and
p.001151: identification of opportunities for public-private sector partnerships.
p.001151: (c) MEMBERSHIP.—
p.001151: (1) IN GENERAL.—The Advisory Council shall, in accord- ance with this subsection, be composed of
p.001151: appointed members and ex officio members. All members of the Advisory Council shall be voting members other
p.001151: than the individuals designated under paragraph (3)(B) as ex officio members.
p.001151: (2) APPOINTED MEMBERS.—The Secretary shall appoint to the Advisory Council 21 appropriately qualified
p.001151: individuals. At least 17 members of the Advisory Council shall be representa- tives of the public who are not
p.001151: officers or employees of the United States and at least 1 member who shall be a specialist in the rural aspects of
p.001151: 1 or more of the professions or fields de- scribed in subparagraphs (A) through (G). The Secretary shall
p.001151: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001151:
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p.001151: Sec. 941 PUBLIC HEALTH SERVICE ACT 1152
p.001151:
p.001151: ensure that the appointed members of the Council, as a group, are representative of professions and entities
p.001151: concerned with, or affected by, activities under this title and under section 1142 of the Social Security
p.001151: Act. Of such members—
p.001151: (A) three shall be individuals distinguished in the con- duct of research, demonstration projects, and
p.001151: evaluations with respect to health care;
p.001151: (B) three shall be individuals distinguished in the fields of health care quality research or health
p.001151: care im- provement;
p.001151: (C) three shall be individuals distinguished in the practice of medicine of which at least one shall be
p.001151: a pri- mary care practitioner;
p.001151: (D) three shall be individuals distinguished in the other health professions;
p.001151: (E) three shall be individuals either representing the private health care sector, including health plans,
p.001151: pro- viders, and purchasers or individuals distinguished as ad- ministrators of health care delivery systems;
...

p.001153: 5, United States Code, that govern appointments in the competitive service, and without regard to the
p.001153: provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification
p.001153: and pay rates under the General Schedule.
p.001153: (2) MEMBERSHIP.—The members of any peer review group established under this section shall be appointed
p.001153: from among
p.001153: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001153: Sec. 943 PUBLIC HEALTH SERVICE ACT 1154
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p.001153: January 30, 2020
p.001153:
p.001153: individuals who by virtue of their training or experience are eminently qualified to carry out the duties of
p.001153: such peer review group. Officers and employees of the United States may not constitute more than 25 percent of
p.001153: the membership of any such group. Such officers and employees may not receive compensa- tion for service on such groups
p.001153: in addition to the compensation otherwise received for these duties carried out as such officers and employees.
p.001153: (3) DURATION.—Notwithstanding section 14(a) of the Fed- eral Advisory Committee Act, peer review groups
p.001153: established under this section may continue in existence until otherwise provided by law.
p.001153: (4) QUALIFICATIONS.—Members of any peer review group shall, at a minimum, meet the following requirements:
p.001153: (A) Such members shall agree in writing to treat infor- mation received, pursuant to their work for the group,
p.001153: as confidential information, except that this subparagraph shall not apply to public records and public
p.001153: information.
p.001153: (B) Such members shall agree in writing to recuse themselves from participation in the peer review of specific
p.001153: applications which present a potential personal conflict of interest or appearance of such conflict,
p.001153: including employ- ment in a directly affected organization, stock ownership, or any financial or other
p.001153: arrangement that might intro- duce bias in the process of peer review.
p.001153: (d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS IN CERTAIN CASES.—In the case of applications for financial
p.001153: assistance whose direct costs will not exceed $100,000, the Director may make appro- priate adjustments in the
p.001153: procedures otherwise established by the Director for the conduct of peer review under this section. Such ad-
p.001153: justments may be made for the purpose of encouraging the entry of individuals into the field of
p.001153: research, for the purpose of encour- aging clinical practice-oriented or provider-based research, and for
p.001153: such other purposes as the Director may determine to be appro- priate.
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p.001155: detailing personnel and the fair market value of any supplies, equipment, or services provided by the
p.001155: Director. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001155: expend the amounts withheld.
p.001155: (d) APPLICABILITY OF CERTAIN PROVISIONS WITH RESPECT TO CONTRACTS.—Contracts may be entered into
p.001155: under this part with- out regard to sections 3648 and 3709 of the Revised Statutes (31
p.001155: U.S.C. 529 and 41 U.S.C. 5).
p.001155: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001155:
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p.001157: 1157
p.001157: PUBLIC HEALTH SERVICE ACT
p.001157: Sec. 946
p.001157:
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p.001157: January 30, 2020
p.001157: SEC. 946. ø299c–5¿ CERTAIN ADMINISTRATIVE AUTHORITIES.
p.001157: (a) DEPUTY DIRECTOR AND OTHER OFFICERS AND EMPLOYEES.—
p.001157: (1) DEPUTY DIRECTOR.—The Director may appoint a deputy director for the Agency.
p.001157: (2) OTHER OFFICERS AND EMPLOYEES.—The Director may appoint and fix the compensation of such officers
p.001157: and employ- ees as may be necessary to carry out this title. Except as other- wise provided by law, such officers and
p.001157: employees shall be ap- pointed in accordance with the civil service laws and their com- pensation fixed in accordance
p.001157: with title 5, United States Code.
p.001157: (b) FACILITIES.—The Secretary, in carrying out this title—
p.001157: (1) may acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise through the
p.001157: Admin- istrator of General Services, buildings or portions of buildings in the District of Columbia or
p.001157: communities located adjacent to the District of Columbia for use for a period not to exceed 10 years; and
p.001157: (2) may acquire, construct, improve, repair, operate, and maintain laboratory, research, and other
p.001157: necessary facilities and equipment, and such other real or personal property (in- cluding patents) as the
p.001157: Secretary deems necessary.
p.001157: (c) PROVISION OF FINANCIAL ASSISTANCE.—The Director, in car- rying out this title, may make grants to public and
p.001157: nonprofit enti- ties and individuals, and may enter into cooperative agreements or contracts with public and private
p.001157: entities and individuals.
p.001157: (d) UTILIZATION OF CERTAIN PERSONNEL AND RESOURCES.—
p.001157: (1) DEPARTMENT OF HEALTH AND HUMAN SERVICES.—The Director, in carrying out this title, may utilize
p.001157: personnel and equipment, facilities, and other physical resources of the De- partment of Health and Human
p.001157: Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the
p.001157: physical resources of such Department, and provide technical assistance and advice.
p.001157: (2) OTHER AGENCIES.—The Director, in carrying out this title, may use, with their consent, the services,
...

p.001221: method and data used in calculating the rates of pay- ment.
p.001221: (D) The following differentials in rates of payments may be es- tablished under the systems described in
p.001221: subparagraphs (B) and (C):
p.001221:
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p.001221:
p.001221: January 30, 2020
p.001221: (i) Nominal differentials in such rates may be established to reflect differences in marketing costs and
p.001221: the different ad- ministrative costs of collecting payments from the following categories of members:
p.001221: (I) Individual members (including their families).
p.001221: (II) Small groups of members (as determined under regulations of the Secretary).
p.001221: (III) Large groups of members (as determined under regulations of the Secretary).
p.001221: (ii) Nominal differentials in such rates may be established to reflect the compositing of the rates of payment in a
p.001221: system- atic manner to accommodate group purchasing practices of the various employers.
p.001221: (iii) Differentials in such rates may be established for members enrolled in a health maintenance organization
p.001221: pursu- ant to a contract with a governmental authority under section 1079 or 1086 of title 10, United States
p.001221: Code, or under any other governmental program (other than the health benefits program authorized by
p.001221: chapter 89 of title 5, United States Code) or any health benefits program for employees of States,
p.001221: political subdivision of States, and other public entities.
p.001221: (9) The term ‘‘non-metropolitan area’’ means an area no part of which is within an area designated as
p.001221: a standard metropolitan
p.001221: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001221:
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p.001221:
p.001223: 1223
p.001223: PUBLIC HEALTH SERVICE ACT
p.001223: Sec. 1305
p.001223:
p.001223: statistical area by the Office of Management and Budget and which does not contain a city whose population exceeds
p.001223: fifty thousand in- dividuals.
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p.001223: January 30, 2020
p.001223: LOANS AND LOAN GUARANTEES FOR INITIAL COSTS OF OPERATION
p.001223: SEC. 1305. ø300e–4¿ (a) The Secretary may—
p.001223: (1) make loans to public or private health maintenance or- ganizations to assist them in meeting the amount by
p.001223: which their costs of operation during a period not to exceed the first sixty months of their operation
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p.001229: the ‘‘fund’’) which shall be available to the Secretary without fiscal year limitation, in such amounts
p.001229: as may be specified from time to time in appropriation Acts, to enable him to make loans under this title and
p.001229: to take the action authorized by subsection (f). There shall also be deposited in the fund amounts received by the
p.001229: Secretary as interest payments and repayment of principal on loans made under this title and other
p.001229: property or assets derived by him from his operations re- specting such loans, from the sale of loans
p.001229: under subsection (c) of this section, or from the sale of assets.
p.001229: (f) The Secretary may take such action as he deems appro- priate to protect the interest of the United
p.001229: States in the event of a default on a loan made or guaranteed under this title, including taking possession of,
p.001229: holding, and using real property pledged as security for such a loan or loan guarantee.
p.001229: AUTHORIZATIONS OF APPROPRIATIONS
p.001229: SEC. 1309. ø300e–8¿ (a) For grants under section 1317 there is authorized to be appropriated $1,000,000
p.001229: for each of the fiscal years 1982, 1983, and 1984.
p.001229: (b) To meet the obligations of the loan fund established under section 1308(e) resulting from defaults on loans
p.001229: made from the fund and to meet the other obligations of the fund, there is author- ized to be appropriated to the
p.001229: loan fund for fiscal years 1987, 1988, and 1989, such sums as may be necessary.
p.001229: EMPLOYEES’ HEALTH BENEFITS PLANS
p.001229: SEC. 1310. 3 ø300e–9¿ (a) In accordance with regulations which the Secretary shall prescribe—
p.001229:
p.001229:
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p.001229:
p.001229: January 30, 2020
p.001229: 3 Section 1310 as shown above was added by section 7(b) of Public Law 100–517. Such section provided in part as
p.001229: follows: ‘‘Effective 7 years after the date of the enactment of this Act øOcto- ber 24, 1988¿, section 1310 (42 U.S.C.
p.001229: 300e–9) is amended to read as follows’’.
p.001229: Section 7(a)(3) of such Public Law provides that nothing in section 1310 shall be construed to supersede
p.001229: any provision of a collective bargaining agreement in effect on øOctober 24, 1988¿.
p.001229: Continued
p.001229: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001229: Sec. 1310 PUBLIC HEALTH SERVICE ACT 1230
p.001229:
p.001229: (1) each employer—
p.001229: (A) which is required during any calendar quarter to pay its employees the minimum wage prescribed by section 6
p.001229: of the Fair Labor Standards Act of 1938 (or would be re- quired to pay its employees such wage but for section 13(a) of
p.001229: such Act), and
p.001229: (B) which during such calendar quarter employed an average number of employees of not less than 25, and
p.001229: (2) any State and each political subdivision thereof which during any calendar quarter employed an
p.001229: average number of employees of not less than 25, as a condition of payment to the State of funds under section 317,
p.001229: 318, or 1002,
p.001229: which offers to its employees in the calendar year beginning after such calendar quarter the option of
p.001229: membership in a qualified health maintenance organization which is engaged in the provision of basic health services
p.001229: in a health maintenance organization serv- ice area in which at least 25 of such employees reside shall
p.001229: meet the requirements of subsection (b) with respect to any qualified health maintenance organization
p.001229: offered by the employer or State or political subdivision.
p.001229: (b)(1) If a health benefits plan offered by an employer or a State or political subdivision includes
p.001229: contributions for services of- fered under the plan, the employer or State or political subdivision shall make a
p.001229: contribution under the plan for services offered by a qualified health maintenance organization in an
p.001229: amount which does not financially discriminate against an employee who enrolls in such organization. For
p.001229: purposes of the preceding sentence, an employer’s or a State’s or political subdivision’s contribution
p.001229: does not financially discriminate if the employer’s or State’s or political subdivision’s method of
p.001229: determining the contributions on behalf of all employees is reasonable and is designed to assure
p.001229: employees a fair choice among health benefits plans.
p.001229: (2) Each employer or State or political subdivision which pro- vides payroll deductions as a means of paying
p.001229: employees’ contribu- tions for health benefits or which provides a health benefits plan to which an
p.001229: employee contribution is not required shall, with the consent of an employee who exercises option of
p.001229: membership in a qualified health maintenance organization, arrange for the employ- ee’s contribution for
p.001229: membership in the organization to be paid through payroll deductions.
p.001229: (3) No employer or State or political subdivision shall be re- quired to pay more for health benefits as a
p.001229: result of the application of this subsection than would otherwise be required by any pre- vailing collective
p.001229: bargaining agreement or other legally enforceable contract for the provision of health benefits between the
p.001229: employer or State or political subdivision and its employees.
p.001229: (c) For purposes of this section, the term ‘‘qualified health maintenance organization’’ means (1) a health
p.001229: maintenance organi- zation which has provided assurances satisfactory to the Secretary
p.001229:
p.001229:
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p.001229:
p.001229: January 30, 2020
p.001229: Section 9 of such Public Law provides as follows: ‘‘With respect to abortion services, the Sec- retary of Health and
p.001229: Human Services shall not promulgate or issue any regulations, policy statements, or interpretations or
p.001229: develop any practices concerning the performance of medically necessary procedures if such regulations, policy
p.001229: statements, interpretations, or practices would be inconsistent with those in effect on øOctober 24, 1988¿.’’.
p.001229: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001231: 1231
p.001231: PUBLIC HEALTH SERVICE ACT
p.001231: Sec. 1310
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p.001231: January 30, 2020
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p.001231: basic and supplemental health services because that State by law, regu- lation, or otherwise—
p.001231: (A) requires as a condition to doing business in that State that a medical society approve the
p.001231: furnishing of services by the entity,
p.001231: (B) requires that physicians constitute all or a percent- age of its governing body,
p.001231: (C) requires that all physicians or a percentage of phy- sicians in the locale participate or be permitted to partici-
p.001231: pate in the provision of services for the entity,
p.001231: (D) requires that the entity meet requirements for in- surers of health care services doing business in that State
p.001231: respecting initial capitalization and establishment of finan- cial reserves against insolvency, or
p.001231: (E) imposes requirements which would prohibit the entity from complying with the requirements of this
p.001231: title, and
p.001231: (2) for which a grant, contract, loan, or loan guarantee was made under this title or which is a qualified
p.001231: health mainte- nance organization for purposes of section 1310 (relating to em- ployees’ health benefits plans),
p.001231: such requirements shall not apply to that entity so as to prevent it from operating as a health
p.001231: maintenance organization in accord- ance with section 1301.
p.001231: (b) No State may establish or enforce any law which prevents a health maintenance organization for which
p.001231: a grant, contract, loan, or loan guarantee was made under this title or which is a qualified health
p.001231: maintenance organization for purposes of section 1310 (relating to employees’ health benefits plans), from
p.001231: soliciting members through advertising its services, charges, or other non- professional aspects of its
p.001231: operation. This subsection does not au- thorize any advertising which identifies, refers to, or makes any
p.001231: qualitative judgment concerning, any health professional who pro- vides services for a health maintenance
p.001231: organization.
p.001231: (c) The Secretary shall, within 6 months after the date of the enactment of this subsection, develop a
p.001231: digest of State laws, regula- tions, and practices pertaining to development, establishment, and operation of health
p.001231: maintenance organizations which shall be up- dated at least annually and relevant sections of which shall be pro-
p.001231: vided to the Governor of each State annually. Such digest shall in- dicate which State laws, regulations, and practices
p.001231: appear to be in- consistent with the operation of this section. The Secretary shall
p.001231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001233: 1233
p.001233: PUBLIC HEALTH SERVICE ACT
p.001233: Sec. 1312
p.001233:
p.001233: also insure that appropriate legal consultative assistance is avail- able to the States for the purpose of
p.001233: complying with the provisions of this section.
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p.001233: January 30, 2020
p.001233: CONTINUED REGULATION OF HEALTH MAINTENANCE ORGANIZATIONS
p.001233: SEC. 1312. ø300e–11¿ (a) If the Secretary determines that an entity which received a grant, contract,
p.001233: loan, or loan guarantee under this title as a health maintenance organization or which was included in a health
p.001233: benefits plan offered to employees pursuant to section 1310—
p.001233: (1) fails to provide basic and supplemental services to its members,
p.001233: (2) fails to provide such services in the manner prescribed by section 1301(b), or
p.001233: (3) is not organized or operated in the manner prescribed by section 1301(c),
p.001233: the Secretary may take the action authorized by subsection (b). (b)(1) If the Secretary makes, with respect to any
p.001233: entity which
p.001233: provided assurances to the Secretary under section 1310(d)(1), a determination described in subsection (a), the
p.001233: Secretary shall notify the entity in writing of the determination. Such notice shall specify the manner in which the
p.001233: entity has not complied with such assur- ances and direct that the entity initiate (within 30 days of the date the
p.001233: notice is issued by the Secretary or within such longer period as the Secretary determines is
p.001233: reasonable) such action as may be necessary to bring (within such period as the Secretary shall pre-
p.001233: scribe) the entity into compliance with the assurances. If the entity fails to initiate corrective action within the
p.001233: period prescribed by the notice or fails to comply with the assurances within such period as the Secretary prescribes,
p.001233: then after the Secretary provides the enti- ty a reasonable opportunity for reconsideration of his determina-
p.001233: tion, including, at the entity’s election, a fair hearing (A) the entity shall not be a qualified health
p.001233: maintenance organization for pur- poses of section 1310 until such date as the Secretary determines that
p.001233: it is in compliance with the assurances, and (B) each employer which has offered membership in the entity in compliance
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p.001235: fiscal year only to such extent or in such amounts as are provided in advance by ap- propriation Acts.
p.001235: FINANCIAL DISCLOSURE
p.001235: SEC. 1318. ø300e–17¿ (a) Each health maintenance organiza- tion shall, in accordance with regulations of
p.001235: the Secretary, report to the Secretary financial information which shall include the fol- lowing:
p.001235: (1) Such information as the Secretary may require dem- onstrating that the health maintenance organization has
p.001235: a fis- cally sound operation.
p.001235: (2) A copy of the report, if any, filed with the Centers for Medicare & Medicaid Services containing
p.001235: the information re- quired to be reported under section 1124 of the Social Security Act by disclosing entities
p.001235: and the information required to be supplied under section 1902(a)(38) of such Act.
p.001235: (3) A description of transactions, as specified by the Sec- retary, between the health maintenance
p.001235: organization and a party in interest. Such transactions shall include—
p.001235: (A) any sale or exchange, or leasing of any property between the health maintenance organization and a party
p.001235: in interest;
p.001235: (B) any furnishing for consideration of goods, services (including management services), or facilities
p.001235: between the health maintenance organization and a party in interest, but not including salaries paid to
p.001235: employees for services provided in the normal course of their employment and health services provided
p.001235: to members by hospitals and other providers and by staff, medical group (or groups), in- dividual practice
p.001235: association (or associations), or any com- bination thereof; and
p.001235: (C) any lending of money or other extension of credit between a health maintenance organization and a party in
p.001235: interest.
p.001235: The Secretary may require that information reported respecting a health maintenance organization which
p.001235: controls, is controlled by, or is under common control with, another entity be in the form of a
p.001235: consolidated financial statement for the organization and such entity.
p.001235: (b) For the purposes of this section the term ‘‘party in interest’’ means:
p.001235:
p.001235:
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p.001235: January 30, 2020
p.001235: (1) any director, officer, partner, or employee responsible for management or administration of a health
p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
p.001235: centum of the equity of the or- ganization, any person who is the beneficial owner of a mort- gage, deed of
p.001235: trust, note, or other interest secured by, and val- uing more than 5 per centum of the health maintenance orga-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001235:
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p.001237: (c) SPECIAL CONSIDERATION FOR CERTAIN STATES.—In making grants under subsection (a) to States whose
p.001237: initial grants under such subsection are made for fiscal year 1995 or any subsequent fiscal year, the
p.001237: Secretary shall give special consideration to any
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001239: PUBLIC HEALTH SERVICE ACT
p.001239: Sec. 1502
p.001239:
p.001239: State whose proposal for carrying out programs under such sub- section—
p.001239: (1) has been approved through a process of peer review;
p.001239:
p.001239: and
p.001239: is—
p.001239: (2) is made with respect to geographic areas in which there
p.001239:
p.001239: (A) a substantial rate of mortality from breast or cer- vical cancer; or
p.001239: (B) a substantial incidence of either of such cancers.
p.001239: (d) COORDINATING COMMITTEE REGARDING YEAR 2020 HEALTH OBJECTIVES.—The Secretary, acting through the Director
p.001239: of the Centers for Disease Control and Prevention, shall establish a com- mittee to coordinate the activities of
p.001239: the agencies of the Public Health Service (and other appropriate Federal agencies) that are carried out
p.001239: toward achieving the objectives established by the Sec- retary for reductions in the rate of mortality from
p.001239: breast and cer- vical cancer in the United States by the year 2020. Such committee shall be comprised of Federal
p.001239: officers or employees designated by the heads of the agencies involved to serve on the committee as
p.001239: representatives of the agencies, and such representatives from other public or private entities as the
p.001239: Secretary determines to be appropriate.
p.001239: SEC. 1502. ø300l¿ REQUIREMENT OF MATCHING FUNDS.
p.001239: (a) IN GENERAL.—The Secretary may not make a grant under section 1501 unless the State involved agrees,
p.001239: with respect to the costs to be incurred by the State in carrying out the purpose de- scribed in such
p.001239: section, to make available non-Federal contribu- tions (in cash or in kind under subsection (b)) toward such costs
p.001239: in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such
p.001239: contributions may be made directly or through donations from public or private entities.
p.001239: (b) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBU-
p.001239: TION.—
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p.001239: (1) IN GENERAL.—Non-Federal contributions required in subsection (a) may be in cash or in kind, fairly
p.001239: evaluated, in- cluding equipment or services (and excluding indirect or over- head costs). Amounts provided
p.001239: by the Federal Government, or services assisted or subsidized to any significant extent by the Federal
p.001239: Government, may not be included in determining the amount of such non-Federal contributions.
p.001239: (2) MAINTENANCE OF EFFORT.—In making a determination of the amount of non-Federal contributions for purposes of
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p.001243: 1243
p.001243: PUBLIC HEALTH SERVICE ACT
p.001243: Sec. 1504
p.001243:
p.001243: (ii) paragraphs (3) through (6) of section 1501(a).
p.001243: (C) A description of the number of States receiving waivers under paragraph (1) annually.
p.001243: (D) With respect to States receiving a waiver under paragraph (1), a description of—
p.001243: (i) the number of women receiving services under paragraphs (1), (2), and (3) of section 1501(a) in
p.001243: pro- grams before and after the granting of such waiver; and
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p.001243: (ii) the average annual level of State fiscal ex- penditures for the services and activities described
p.001243: in paragraphs (1) and (2) of section 1501(a) for the year preceding the first year for which the waiver
p.001243: was granted.
p.001243: (4) LIMITATION.—Amounts to which a waiver applies under this subsection shall not be used to increase the number of
p.001243: sal- aried employees.
p.001243: (5) DEFINITIONS.—In this subsection:
p.001243: (A) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the meaning given the term in section 4 of the Indian
p.001243: Health Care Improvement Act (25 U.S.C. 1603).
p.001243: (B) TRIBAL ORGANIZATION.—The term ‘‘tribal organiza- tion’’ has the meaning given the term in section 4 of
p.001243: the Indian Health Care Improvement Act.
p.001243: (C) STATE.—The term ‘‘State’’ means each of the sev- eral States of the United States, the District of
p.001243: Columbia, the Commonwealth of Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana
p.001243: Islands, the Re- public of the Marshall Islands, the Federated States of Mi- cronesia, the Republic of Palau, an
p.001243: Indian tribe, and a tribal organization.
p.001243: (6) SUNSET.—The Secretary may not grant a waiver or ex- tension under this subsection after September 30, 2012.
p.001243: SEC. 1504. ø300n¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001243: (a) PRIORITY FOR LOW-INCOME WOMEN.—The Secretary may not make a grant under section 1501 unless the
p.001243: State involved agrees that low-income women will be given priority in the provi- sion of services and
p.001243: activities pursuant to paragraphs (1) and (2) of section 1501(a).
p.001243: (b) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under section
p.001243: 1501 unless the State involved agrees that, if a charge is imposed for the provision of services or activities under
p.001243: the grant, such charge—
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p.001263: health systems agen- cies and State Agencies and shall give special consideration to ap- plications (i) which will
p.001263: assist health systems agencies and State Agencies to meet the goals in their health systems plans and State
p.001263: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001265: 1265
p.001265: PUBLIC HEALTH SERVICE ACT
p.001265: Sec. 1642
p.001265:
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p.001265: January 30, 2020
p.001265: health plans, or (ii) which will result in the greatest reduction in hospital costs within a health service
p.001265: area.
p.001265: (c)(1) Except as provided in paragraph (3), the Secretary may not approve an application submitted under
p.001265: subsection (b) unless the Secretary of Labor has certified that fair and equitable ar- rangements have
p.001265: been made to protect the interests of employees affected by the discontinuance of services against a
p.001265: worsening of their positions with respect to their employment, including ar- rangements to preserve the
p.001265: rights of employees under collective- bargaining agreements, continuation of collective-bargaining rights
p.001265: consistent with the provisions of the National Labor Relations Act, reassignment of affected employees to other
p.001265: jobs, retraining pro- grams, protecting pension, health benefits, and other fringe bene- fits of affected
p.001265: employees, and arranging adequate severance pay, if necessary.
p.001265: (2) The Secretary of Labor shall by regulation prescribe guide- lines for arrangements for the protection of the
p.001265: interests of employ- ees affected by the discontinuance of hospital services. The Sec- retary of Labor
p.001265: shall consult with the Secretary of Health, Edu- cation, and Welfare in the promulgation of such
p.001265: guidelines. Such guidelines shall first be promulgated not later than the promulga- tion of regulations by
p.001265: the Secretary for the administration of the grants authorized by section 1641.
p.001265: (3) The Secretary of Labor shall review each application sub- mitted under subsection (b) to determine
p.001265: if the arrangements de- scribed in paragraph (1) have been made and if they are satisfac- tory and
p.001265: shall notify the Secretary respecting his determination. Such review shall be completed within—
p.001265: (A) ninety days from the date of the receipt of the applica- tion from the Secretary of Health, Education, and
p.001265: Welfare, or
p.001265: (B) one hundred and twenty days from such date if the Secretary of Labor has by regulation
p.001265: prescribed the cir- cumstances under which the review will require at least one hundred and twenty days.
p.001265: If within the applicable period, the Secretary of Labor does not no- tify the Secretary of Health, Education, and
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p.001267:
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p.001267: January 30, 2020
p.001267: (A) incorporate appropriate health education compo- nents into our society, especially into all aspects of
p.001267: edu- cation and health care,
p.001267: (B) increase the application and use of health knowl- edge, skills, and practices by the general population in
p.001267: its patterns of daily living, and
p.001267: (C) establish systematic processes for the exploration, development, demonstration, and evaluation of
p.001267: innovative health promotion concepts;
p.001267: (4) undertake and support research and demonstrations re- specting health information and health promotion,
p.001267: preventive health services, and education in the appropriate use of health care;
p.001267: (5) undertake and support appropriate training in the op- eration of programs concerned with, health
p.001267: information and health promotion, preventive health services, and education in the appropriate use of health care;
p.001267: (6) undertake and support, through improved planning and implementation of tested models and evaluation of
p.001267: results, ef- fective and efficient programs respecting health information and health promotion, preventive
p.001267: health services, and edu- cation in the appropriate use of health care;
p.001267: (7)(A) develop model programs through which employers in the public sector, and employers that are small businesses (as
p.001267: defined in section 3 of the Small Business Act), can provide for their employees a program to promote healthy
p.001267: behaviors and to discourage participation in unhealthy behaviors;
p.001267: (B) provide technical assistance to public and private em- ployers in implementing such programs (including
p.001267: private em- ployers that are not small businesses and that will implement programs other than the programs developed by
p.001267: the Secretary pursuant to subparagraph (A)); and
p.001267: (C) in providing such technical assistance, give preference to small businesses;
p.001267: (8) foster the exchange of information respecting, and fos- ter cooperation in the conduct of, research,
p.001267: demonstration, and training programs respecting health information and health promotion, preventive health
p.001267: services, and education in the ap- propriate use of health care;
p.001267: (9) provide technical assistance in the programs referred to in paragraph (8);
p.001267: (10) use such other authorities for programs respecting health information and health promotion, preventive
p.001267: health services, and education in the appropriate use of health care as are available and coordinate
p.001267: such use with programs con- ducted under this title; and
p.001267: (11) establish in the Office of the Assistant Secretary for Health an Office of Disease Prevention and Health
p.001267: Promotion, which shall—
p.001267: (A) coordinate all activities within the Department which relate to disease prevention, health promotion,
p.001267: pre- ventive health services, and health information and edu- cation with respect to the appropriate use
p.001267: of health care;
p.001267: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001267:
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
p.001275: (2) DUTIES.—The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section,
p.001275: including advice on the development of goals and specific program activi- ties under paragraphs (1) through (10)
p.001275: of subsection (b) for each racial and ethnic minority group.
p.001275: (3) CHAIR.—The chairperson of the Committee shall be se- lected by the Secretary from among the members of the voting
p.001275: members of the Committee. The term of office of the chair- person shall be 2 years.
p.001275: (4) COMPOSITION.—
p.001275: (A) The Committee shall be composed of 12 voting members appointed in accordance with subparagraph (B),
p.001275: and nonvoting, ex officio members designated in subpara- graph (C).
p.001275: (B) The voting members of the Committee shall be ap- pointed by the Secretary from among individuals who are
p.001275: not officers or employees of the Federal Government and who have expertise regarding issues of minority
p.001275: health. The racial and ethnic minority groups shall be equally rep- resented among such members.
p.001275: (C) The nonvoting, ex officio members of the Com- mittee shall be such officials of the Department of
p.001275: Health and Human Services as the Secretary determines to be ap- propriate.
p.001275: (5) TERMS.—Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall
p.001275: initially ap- point a portion of the members to terms of 1 year, 2 years, and 3 years.
p.001275: (6) VACANCIES.—If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary
p.001275: within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which the
p.001275: predecessor of such mem- ber was appointed. The vacancy shall not affect the power of the remaining members
p.001275: to execute the duties of the Com- mittee.
p.001275: (7) COMPENSATION.—Members of the Committee who are officers or employees of the United States shall serve
p.001275: without compensation. Members of the Committee who are not officers or employees of the United States shall
p.001275: receive compensation, for each day (including travel time) they are engaged in the performance of the
p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
p.001275: (1) RECOMMENDATIONS REGARDING LANGUAGE.—
p.001275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001275: Sec. 1707 PUBLIC HEALTH SERVICE ACT 1276
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p.001275:
p.001275: (A) PROFICIENCY IN SPEAKING ENGLISH.—The Deputy Assistant Secretary shall consult with the Director of
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p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
p.001301: (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional
p.001301: dis- turbance to other members of the Council is sufficient to
p.001301: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001301:
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p.001301: Sec. 1915 PUBLIC HEALTH SERVICE ACT 1302
p.001301:
p.001301: provide adequate representation of such children in the de- liberations of the Council; and
p.001301: (B) not less than 50 percent of the members of the Council are individuals who are not State employees
p.001301: or providers of mental health services.
p.001301: (d) DEFINITION.—For purposes of this section, the term ‘‘Coun- cil’’ means a State mental health planning council.
p.001301: SEC. 1915. ø300x–4¿ ADDITIONAL PROVISIONS.
p.001301: (a) REVIEW OF STATE PLAN BY MENTAL HEALTH PLANNING COUNCIL.—The Secretary may make a grant under section
p.001301: 1911 to a State only if—
p.001301: (1) the plan submitted under section 1912(a) with respect to the grant and the report of the State under
p.001301: section 1942(a) concerning the preceding fiscal year has been reviewed by the State mental health planning
p.001301: council under section 1914; and
p.001301: (2) the State submits to the Secretary any recommenda- tions received by the State from such council for
p.001301: modifications to the plan (without regard to whether the State has made the recommended modifications) and any comments
p.001301: concerning the annual report.
p.001301: (b) MAINTENANCE OF EFFORT REGARDING STATE EXPENDITURES FOR MENTAL HEALTH.—
p.001301: (1) IN GENERAL.—A funding agreement for a grant under section 1911 is that the State involved will maintain
p.001301: State ex- penditures for community mental health services at a level that is not less than the average
p.001301: level of such expenditures maintained by the State for the 2-year period preceding the fis- cal year for which the
p.001301: State is applying for the grant.
p.001301: (2) EXCLUSION OF CERTAIN FUNDS.—The Secretary may ex- clude from the aggregate State expenditures under
p.001301: subsection (a), funds appropriated to the principle agency for authorized activities which are of a
p.001301: non-recurring nature and for a specific purpose.
p.001301: (3) WAIVER.—
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p.001335: January 30, 2020
p.001335:
p.001335: (c) RELIGIOUS CHARACTER AND INDEPENDENCE.—
p.001335: (1) IN GENERAL.—A religious organization that provides services under any substance abuse program under this
p.001335: title or title V shall retain its independence from Federal, State, and local governments, including such
p.001335: organization’s control over the definition, development, practice, and expression of its reli- gious beliefs.
p.001335: (2) ADDITIONAL SAFEGUARDS.—Neither the Federal Govern- ment nor a State or local government shall require a religious
p.001335: organization—
p.001335: (A) to alter its form of internal governance; or
p.001335: (B) to remove religious art, icons, scripture, or other symbols,
p.001335: in order to be eligible to provide services under any substance abuse program under this title or title V.
p.001335: (d) EMPLOYMENT PRACTICES.—
p.001335: (1) SUBSTANCE ABUSE.—A religious organization that pro- vides services under any substance abuse program
p.001335: under this title or title V may require that its employees providing serv- ices under such program
p.001335: adhere to rules forbidding the use of drugs or alcohol.
p.001335: (2) TITLE VII EXEMPTION.—The exemption of a religious or- ganization provided under section 702 or 703(e)(2) of the
p.001335: Civil Rights Act of 1964 (42 U.S.C. 2000e–1, 2000e–2(e)(2)) regard- ing employment practices shall not be
p.001335: affected by the religious organization’s provision of services under, or receipt of funds from, any substance
p.001335: abuse program under this title or title V.
p.001335: (e) RIGHTS OF BENEFICIARIES OF ASSISTANCE.—
p.001335: (1) IN GENERAL.—If an individual described in paragraph
p.001335: (3) has an objection to the religious character of the organiza- tion from which the individual receives, or
p.001335: would receive, serv- ices funded under any substance abuse program under this title or title V, the appropriate
p.001335: Federal, State, or local govern- mental entity shall provide to such individual (if otherwise eli- gible for such
p.001335: services) within a reasonable period of time after the date of such objection, services that—
p.001335: (A) are from an alternative provider that is accessible to the individual; and
p.001335: (B) have a value that is not less than the value of the services that the individual would have received from such
p.001335: organization.
p.001335: (2) NOTICE.—The appropriate Federal, State, or local gov- ernmental entity shall ensure that notice is
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p.001377: the trust fund which has been established to provide such compensation shall be subrograted 18 to all
p.001377: rights of the petitioner with respect to the vac- cine-related injury or death for which compensation was paid,
p.001377: ex-
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p.001377: January 30, 2020
p.001377: 16 Effective October 1, 1988.
p.001377: 17 See footnote for section 2112(g).
p.001377: 18 So in law. Probably should be ‘‘subrogated’’.
p.001377: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001377:
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p.001377: Sec. 2119 PUBLIC HEALTH SERVICE ACT 1378
p.001377:
p.001377: cept that the trust fund may not recover under such rights an amount greater than the amount of compensation
p.001377: paid to the peti- tioner.
p.001377: (b) DISPOSITION OF AMOUNTS RECOVERED.—Amounts recovered under subsection (a) shall be collected on behalf
p.001377: of, and deposited in, the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal
p.001377: Revenue Code of 1986.
p.001377: ADVISORY COMMISSION ON CHILDHOOD VACCINES
p.001377: SEC. 2119. ø300aa–19¿ (a) ESTABLISHMENT.—There is estab- lished the Advisory Commission on Childhood
p.001377: Vaccines. The Com- mission shall be composed of:
p.001377: (1) Nine members appointed by the Secretary as follows:
p.001377: (A) Three members who are health professionals, who are not employees of the United States, and who have ex- pertise in
p.001377: the health care of children, the epidemiology, eti- ology, and prevention of childhood diseases, and the ad-
p.001377: verse reactions associated with vaccines, of whom at least two shall be pediatricians.
p.001377: (B) Three members from the general public, of whom at least two shall be legal representatives of children who
p.001377: have suffered a vaccine-related injury or death.
p.001377: (C) Three members who are attorneys, of whom at least one shall be an attorney whose specialty includes
p.001377: representation of persons who have suffered a vaccine-re- lated injury or death and of whom one shall be an
p.001377: attorney whose specialty includes representation of vaccine manu- facturers.
p.001377: (2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the
p.001377: Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs (or the designees of such
p.001377: officials), each of whom shall be a nonvoting ex officio member.
p.001377: The Secretary shall select members of the Commission within 90 days of the effective date of this part. 19
p.001377: The members of the Com- mission shall select a Chair from among the members.
p.001377: (b) TERM OF OFFICE.—Appointed members of the Commission shall be appointed for a term of office of 3 years,
p.001377: except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term
p.001377: of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary.
p.001377: (c) MEETINGS.—The Commission shall first meet within 60 days after all members of the Commission are
p.001377: appointed, and thereafter shall meet not less often than four times per year and at the call of the
p.001377: chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot
p.001377: of a majority of the voting members of the Commission present at the meeting.
p.001377: (d) COMPENSATION.—Members of the Commission who are offi- cers or employees of the Federal Government shall
p.001377: serve as mem- bers of the Commission without compensation in addition to that received in their regular
p.001377: public employment. Members of the Com- mission who are not officers or employees of the Federal Govern-
p.001377:
p.001377:
p.001377:
p.001377: January 30, 2020
p.001377: 19 Effective October 1, 1988.
p.001377:
p.001377: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001377:
p.001377:
p.001377:
p.001377:
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p.001377:
p.001377:
p.001379: 1379
p.001379: PUBLIC HEALTH SERVICE ACT
p.001379: Sec. 2121
p.001379:
p.001379: ment shall be compensated at a rate not to exceed the daily equiva- lent of the rate in effect for grade GS–18
p.001379: of the General Schedule for each day (including traveltime) they are engaged in the per- formance of their
p.001379: duties as members of the Commission. All mem- bers, while so serving away from their homes or regular places
p.001379: of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same
p.001379: manner as such expenses are au- thorized by section 5703, title 5, United States Code, for employees serving
p.001379: intermittently.
p.001379: (e) STAFF.—The Secretary shall provide the Commission with such professional and clerical staff, such
p.001379: information, and the serv- ices of such consultants as may be necessary to assist the Commis- sion in carrying out
p.001379: effectively its functions under this section.
p.001379: (f) FUNCTIONS.—The Commission shall—
p.001379: (1) advise the Secretary on the implementation of the Pro- gram,
p.001379: (2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine
p.001379: Injury Table,
p.001379: (3) advise the Secretary in implementing the Secretary’s responsibilities under section 2127 regarding
p.001379: the need for childhood vaccination products that result in fewer or no sig- nificant adverse reactions,
p.001379: (4) survey Federal, State, and local programs and activities relating to the gathering of information on
p.001379: injuries associated with the administration of childhood vaccines, including the adverse reaction reporting
p.001379: requirements of section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data
p.001379: related to the frequency and severity of ad- verse reactions associated with childhood vaccines, and
p.001379: (5) recommend to the Director of the National Vaccine Pro- gram research related to vaccine injuries which should be
p.001379: con- ducted to carry out this subtitle.
p.001379: PART B—ADDITIONAL REMEDIES
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379: January 30, 2020
p.001379:
p.001379: AUTHORITY TO BRING ACTIONS
...

p.001387: 34th through the 36th month after such date ............................. 450
p.001387: 37th through the 39th month after such date ............................. 488
p.001387: 40th through the 42nd month after such date ............................. 525
p.001387: 43rd through the 45th month after such date ............................. 563
p.001387: 46th through the 48th month after such date ............................. 600.
p.001387:
p.001387: TITLE XXII—REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EM- PLOYEES
p.001387: SEC. 2201. ø300bb–1¿ STATE AND LOCAL GOVERNMENTAL GROUP HEALTH PLANS MUST PROVIDE CONTINUATION
p.001387: COV- ERAGE TO CERTAIN INDIVIDUALS.
p.001387: (a) IN GENERAL.—In accordance with regulations which the Secretary shall prescribe, each group health plan
p.001387: that is main- tained by any State that receives funds under this Act, by any po- litical subdivision of such a
p.001387: State, or by any agency or instrumen- tality of such a State or political subdivision, shall provide,
p.001387: in ac- cordance with this title, that each qualified beneficiary who would lose coverage under the plan as a
p.001387: result of a qualifying event is en- titled, under the plan, to elect, within the election period, continu- ation
p.001387: coverage under the plan.
p.001387: (b) EXCEPTION FOR CERTAIN PLANS.—Subsection (a) shall not apply to—
p.001387: (1) any group health plan for any calendar year if all em- ployers maintaining such plan normally
p.001387: employed fewer than 20 employees on a typical business day during the preceding calendar year, or
p.001387: (2) any group health plan maintained for employees by the government of the District of Columbia or any territory or
p.001387: pos- session of the United States or any agency or instrumentality.
p.001387: SEC. 2202. ø300bb–2¿ CONTINUATION COVERAGE.
p.001387: For purposes of section 2201, the term ‘‘continuation coverage’’ means coverage under the plan which meets the
p.001387: following require- ments:
p.001387:
p.001387:
p.001387:
p.001387:
p.001387:
p.001387: January 30, 2020
p.001387: (1) TYPE OF BENEFIT COVERAGE.—The coverage must con- sist of coverage which, as of the time the coverage is
p.001387: being pro- vided, is identical to the coverage provided under the plan to similarly situated beneficiaries
p.001387: under the plan with respect to whom a qualifying event has not occurred. If coverage is modi-
p.001387: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001387:
p.001387:
p.001387:
p.001387:
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p.001387:
p.001387:
p.001389: 1389
p.001389: PUBLIC HEALTH SERVICE ACT
p.001389: Sec. 2202
p.001389:
p.001389: fied under the plan for any group of similarly situated bene- ficiaries, such coverage shall also be modified
p.001389: in the same man- ner for all individuals who are qualified beneficiaries under the plan pursuant to this part 1 in
p.001389: connection with such group.
p.001389: (2) PERIOD OF COVERAGE.—The coverage must extend for at least the period beginning on the date of
p.001389: the qualifying event and ending not earlier than the earliest of the following:
p.001389: (A) MAXIMUM REQUIRED PERIOD.—
...

p.001391: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001391:
p.001391:
p.001391:
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p.001391:
p.001391: Sec. 2205 PUBLIC HEALTH SERVICE ACT 1392
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
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p.001391:
p.001391:
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p.001391:
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p.001391:
p.001391:
p.001391:
p.001391:
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p.001391:
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p.001391:
p.001391:
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p.001391:
p.001391:
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p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391:
p.001391: January 30, 2020
p.001391:
p.001391: (ii) the percentage increase or decrease in the im- plicit price deflator of the gross national product (cal-
p.001391: culated by the Department of Commerce and pub- lished in the Survey of Current Business) for the 12-
p.001391: month period ending on the last day of the sixth month of such preceding determination period.
p.001391: (C) SUBPARAGRAPH (B) NOT TO APPLY WHERE SIGNIFI- CANT CHANGE.—A plan administrator may not elect
p.001391: to have subparagraph (B) apply in any case in which there is any significant difference, between the determination
p.001391: pe- riod and the preceding determination period, in coverage under, or in employees covered by, the
p.001391: plan. The deter- mination under the preceding sentence for any determina- tion period shall be made at the
p.001391: same time as the deter- mination under paragraph (3).
p.001391: (3) DETERMINATION PERIOD.—The determination of any ap- plicable premium shall be made for a period of 12 months and
p.001391: shall be made before the beginning of such period.
p.001391: SEC. 2205. ø300bb–5¿ ELECTION.
p.001391: (a) IN GENERAL.—For purposes of this title—
p.001391: (1) ELECTION PERIOD.—The term ‘‘election period’’ means the period which—
p.001391: (A) begins not later than the date on which coverage terminates under the plan by reason of a qualifying
p.001391: event,
p.001391: (B) is of at least 60 days’ duration, and
p.001391: (C) ends not earlier than 60 days after the later of—
p.001391: (i) the date described in subparagraph (A), or
p.001391: (ii) in the case of any qualified beneficiary who re- ceives notice under section 2206(4), the date of such
p.001391: notice.
p.001391: (2) EFFECT OF ELECTION ON OTHER BENEFICIARIES.—Except as otherwise specified in an election, any election
p.001391: of continu- ation coverage by a qualified beneficiary described in subpara- graph (A)(i) or (B) of section 2208(3)
p.001391: shall be deemed to include an election of continuation coverage on behalf of any other qualified beneficiary
p.001391: who would lose coverage under the plan by reason of the qualifying event. If there is a choice among
p.001391: types of coverage under the plan, each qualified beneficiary is entitled to make a separate selection among
p.001391: such types of cov- erage.
p.001391: (b) TEMPORARY EXTENSION OF COBRA ELECTION PERIOD FOR
p.001391: CERTAIN INDIVIDUALS.—
...

p.001409: (1) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be
p.001409: necessary for each fiscal year.
p.001409: (2) Amounts appropriated pursuant to paragraph (1) to carry out subsection (c) shall remain available until
p.001409: expended.
p.001409: PART C—RESEARCH TRAINING
p.001409: SEC. 2341. ø300cc–31¿ FELLOWSHIPS AND TRAINING.
p.001409: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control 5, shall establish
p.001409: fellowship and training programs to be conducted by the Centers for Disease Con- trol 5 to train individuals to
p.001409: develop skills in epidemiology, surveil- lance, testing, counseling, education, information, and laboratory
p.001409: analysis relating to acquired immune deficiency syndrome. Such programs shall be designed to enable health
p.001409: professionals and health personnel trained under such programs to work, after re- ceiving such training,
p.001409: in national and international efforts toward the prevention, diagnosis, and treatment of acquired immune defi-
p.001409: ciency syndrome.
p.001409: (b) PROGRAMS CONDUCTED BY NATIONAL INSTITUTE OF MENTAL
p.001409: HEALTH.—The Secretary, acting through the Director of the Na- tional Institute of Mental Health, shall
p.001409: conduct or support fellow- ship and training programs for individuals pursuing graduate or postgraduate
p.001409: study in order to train such individuals to conduct scientific research into the psychological and social
p.001409: sciences as such sciences relate to acquired immune deficiency syndrome.
p.001409: (c) RELATIONSHIP TO LIMITATION ON NUMBER OF EMPLOYEES.— Any individual receiving a fellowship or receiving
p.001409: training under subsection (a) or (b) shall not be included in any determination of the number of full-time
p.001409: equivalent employees of the Department of Health and Human Services for the purpose of any limitation on the
p.001409: number of such employees established by law prior to, on, or after the date of the enactment of the AIDS
p.001409: Amendments of 1988.
p.001409: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001409: to be appropriated such sums as may be necessary for each fiscal year.
p.001409:
p.001409:
p.001409:
p.001409:
p.001409:
p.001409:
p.001409:
p.001409:
p.001409: January 30, 2020
p.001409: 5 So in law. Section 312(d)(21) of Public Law 102–531 (106 Stat. 3505) provided that section 2341(a) is
p.001409: amended by striking ‘‘Centers for Disease Control’’ and inserting ‘‘Centers for Disease Control and Prevention’’.
p.001409: The amendment cannot be executed because it does not specify to which of the instances of such term the
p.001409: amendment applies.
p.001409: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001409:
p.001409:
p.001409:
p.001409:
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p.001409:
p.001409: Sec. 2351 PUBLIC HEALTH SERVICE ACT 1410
p.001409:
p.001409: PART D—OFFICE OF AIDS RESEARCH
p.001409: Subpart I—Interagency Coordination of Activities
p.001409: SEC. 2351. ø300cc–40¿ ESTABLISHMENT OF OFFICE.
p.001409: (a) IN GENERAL.—There is established within the National In- stitutes of Health an office to be known as the
p.001409: Office of AIDS Re- search. The Office shall be headed by a director, who shall be ap- pointed by the
p.001409: Secretary.
p.001409: (b) DUTIES.—
p.001409: (1) INTERAGENCY COORDINATION OF AIDS ACTIVITIES.—With respect to acquired immune deficiency syndrome, the
...

p.001415: (2) CONGRESSIONAL DISAPPROVAL OF PROJECTS.—
p.001415: (A) Amounts in the Fund may not be expended for the fiscal year involved for an identified set of AIDS activities, or a
p.001415: category of AIDS activities, for which—
p.001415: (i)(I) amounts were made available in an appro- priations Act for the preceding fiscal year; and
p.001415: (II) amounts are not made available in any appro- priations Act for the fiscal year involved; or
p.001415: (ii) amounts are by law prohibited from being ex- pended.
p.001415: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001415:
p.001415:
p.001415:
p.001415:
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p.001415:
p.001415: Sec. 2359 PUBLIC HEALTH SERVICE ACT 1416
p.001415:
p.001415: (B) A determination under subparagraph (A)(i) of whether amounts have been made available in
p.001415: appropria- tions Acts for a fiscal year shall be made without regard to whether such Acts make available
p.001415: amounts for the Fund.
p.001415: (3) INVESTMENT OF FUND AMOUNTS.—Amounts in the Fund may not be invested.
p.001415: (d) APPLICABILITY OF LIMITATION REGARDING NUMBER OF EM- PLOYEES.—The purposes for which amounts in the Fund may
p.001415: be ex- pended include the employment of individuals necessary to carry out identified sets of AIDS activities
p.001415: approved under subsection (a). Any individual employed under the preceding sentence may not be included in any
p.001415: determination of the number of full-time equivalent employees for the Department of Health and Human Services
p.001415: for the purpose of any limitation on the number of such employees es- tablished by law prior to, on, or after the date
p.001415: of the enactment of the National Institutes of Health Revitalization Act of 1993. 7
p.001415: (e) DEFINITIONS.—For purposes of this section:
p.001415: (1) The term ‘‘Fund’’ means the fund established in sub- section (a).
p.001415: (2) The term ‘‘identified set of AIDS activities’’ means a particular set of AIDS activities identified
p.001415: under subsection (a)(2)(A).
p.001415: (f) FUNDING.—
p.001415: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing amounts for the Fund, there is
p.001415: authorized to be appropriated $100,000,000 for each of the fiscal years 1994 through 1996.
p.001415: (2) AVAILABILITY.—Amounts appropriated for the Fund are available until expended.
p.001415: Subpart III—General Provisions
p.001415: SEC. 2359. ø300cc–45¿ GENERAL PROVISIONS REGARDING THE OFFICE.
p.001415: (a) ADMINISTRATIVE SUPPORT FOR OFFICE.—The Secretary, act- ing through the Director of the National Institutes of
p.001415: Health, shall provide administrative support and support services to the Director of the Office and shall ensure
p.001415: that such support takes maximum advantage of existing administrative structures at the agencies of the
p.001415: National Institutes of Health.
p.001415: (b) EVALUATION.—Not later than 5 years after the date of the enactment of National Institutes of Health
p.001415: Revitalization Act of 1993, 7 the Secretary shall conduct an evaluation to—
p.001415: (1) determine the effect of this section on the planning and coordination of the AIDS research programs at the
p.001415: institutes, centers and divisions of the National Institutes of Health;
p.001415: (2) evaluate the extent to which this part has eliminated the duplication of administrative resources
...

p.001445: planning council may not designate (or otherwise be involved in the selec-
p.001445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001445:
p.001445:
p.001445:
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p.001445:
p.001445:
p.001447: 1447
p.001447: PUBLIC HEALTH SERVICE ACT
p.001447: Sec. 2602
p.001447:
p.001447: tion of) particular entities as recipients of any of the amounts provided in the grant.
p.001447: (B) REQUIRED AGREEMENTS.—An individual may serve on the planning council under paragraph (1) only if the in-
p.001447: dividual agrees that if the individual has a financial inter- est in an entity, if the individual is an employee of a
p.001447: public or private entity, or if the individual is a member of a pub- lic or private organization, and such entity or
p.001447: organization is seeking amounts from a grant under section 2601(a), the individual will not, with respect to the
p.001447: purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the
p.001447: process of selecting entities to receive such amounts for such purpose.
p.001447: (C) COMPOSITION OF COUNCIL.—The following applies regarding the membership of a planning council under
p.001447: paragraph (1):
p.001447: (i) Not less than 33 percent of the council shall be individuals who are receiving HIV-related services
p.001447: pursuant to a grant under section 2601(a), are not offi- cers, employees, or consultants to any entity that re-
p.001447: ceives amounts from such a grant, and do not rep- resent any such entity, and reflect the demographics of the
p.001447: population of individuals with HIV/AIDS as deter- mined under paragraph (4)(A). For purposes of the preceding
p.001447: sentence, an individual shall be considered to be receiving such services if the individual is a par- ent of, or a
p.001447: caregiver for, a minor child who is receiv- ing such services.
p.001447: (ii) With respect to membership on the planning council, clause (i) may not be construed as having any effect on
p.001447: entities that receive funds from grants under any of parts B through F but do not receive funds from grants
p.001447: under section 2601(a), on officers or em- ployees of such entities, or on individuals who rep- resent
p.001447: such entities.
p.001447: (6) GRIEVANCE PROCEDURES.—A planning council under paragraph (1) shall develop procedures for addressing
p.001447: griev- ances with respect to funding under this subpart, including procedures for submitting grievances that
p.001447: cannot be resolved to binding arbitration. Such procedures shall be described in the by-laws of the planning
p.001447: council and be consistent with the re- quirements of subsection (c).
p.001447: (7) PUBLIC DELIBERATIONS.—With respect to a planning council under paragraph (1), the following applies:
p.001447: (A) The council may not be chaired solely by an em- ployee of the grantee under section 2601(a).
p.001447: (B) In accordance with criteria established by the Sec- retary:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
p.001447:
...

p.001513: individual may have exposed to HIV/AIDS, hepatitis B, or hepatitis C; and
p.001513: (ii) that emphasizes it is the duty of infected individ- uals to disclose their infected status to
p.001513: their sexual part- ners and their partners in the sharing of hypodermic nee- dles; that provides advice to
p.001513: infected individuals on the manner in which such disclosures can be made; and that emphasizes that it is
p.001513: the continuing duty of the individ- uals to avoid any behaviors that will expose others to HIV/ AIDS, hepatitis
p.001513: B, or hepatitis C; and
p.001513: (D) on the availability of the services of public health authorities with respect to locating and counseling
p.001513: any in- dividual described in subparagraph (C);
p.001513: (4) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001513: liver dis- ease and its impact on HIV/AIDS; and
p.001513: (5) information regarding the availability of hepatitis B vaccine.
p.001513: (c) ADDITIONAL REQUIREMENTS REGARDING APPROPRIATE COUN- SELING.—The Secretary may not make a grant under this part
p.001513: un- less the applicant for the grant agrees that, in counseling individ- uals with respect to HIV/AIDS,
p.001513: the applicant will ensure that the counseling is provided under conditions appropriate to the needs of the
p.001513: individuals.
p.001513: (d) COUNSELING OF EMERGENCY RESPONSE EMPLOYEES.—The Secretary may not make a grant under this part to a State
p.001513: unless the State agrees that, in counseling individuals with respect to HIV/AIDS, the State will ensure that,
p.001513: in the case of emergency re- sponse employees, the counseling is provided to such employees under conditions
p.001513: appropriate to the needs of the employees regard- ing the counseling.
p.001513: (e) RULE OF CONSTRUCTION REGARDING COUNSELING WITHOUT TESTING.—Agreements made pursuant to this section may
p.001513: not be construed to prohibit any grantee under this part from expending the grant for the purpose of
p.001513: providing counseling services described in this section to an individual who does not undergo testing for
p.001513: HIV/AIDS as a result of the grantee or the individual determining that such testing of the individual is not
p.001513: appropriate.
p.001513: SEC. 2663. ø300ff–63¿ APPLICABILITY OF REQUIREMENTS REGARDING CONFIDENTIALITY, INFORMED CONSENT, AND
p.001513: COUN- SELING.
p.001513: The Secretary may not make a grant under this part unless the applicant for the grant agrees that,
p.001513: with respect to testing for HIV/AIDS, any such testing carried out by the applicant with funds
p.001513: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001513:
p.001513:
p.001513:
p.001513:
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p.001513:
p.001513: Sec. 2664 PUBLIC HEALTH SERVICE ACT 1514
p.001513:
p.001513:
p.001513:
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p.001531: (2) The schedule for carrying out subsection (b)(1)(B) shall be the same as the schedule applicable to care
p.001531: grants under part B.
p.001531: (3) The schedule for carrying out subsection (b)(1)(C) shall be the same as the schedule applicable to grants
p.001531: for early intervention services under part C.
p.001531: (4) The schedule for carrying out subsection (b)(1)(D) shall be the same as the schedule applicable to grants
p.001531: for services through projects for HIV-related care under part D.
p.001531: (5) The schedule for carrying out subsection (b)(1)(E) shall be the same as the schedule applicable to grants and
p.001531: contracts for activities through education and training centers under sec- tion 2692.
p.001531:
p.001531: PART G—NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES
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p.001531: January 30, 2020
p.001531: SEC. 2695. ø300ff–131¿ INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT TO NOTIFICATION REQUIREMENTS.
p.001531: (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this part, the Secretary shall
p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
p.001531: (b) SPECIFICATION OF AIRBORNE INFECTIOUS DISEASES.—The list developed by the Secretary under subsection (a)(1)
p.001531: shall include a specification of those infectious diseases on the list that are rou- tinely transmitted through
p.001531: airborne or aerosolized means.
p.001531: (c) DISSEMINATION.—The Secretary shall—
p.001531: (1) transmit to State public health officers copies of the list and guidelines developed by the Secretary under
p.001531: subsection (a) with the request that the officers disseminate such copies as appropriate throughout the
p.001531: States; and
p.001531: (2) make such copies available to the public.
p.001531: SEC. 2695A. ø300ff–132¿ ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE INFECTIOUS DISEASES IN VICTIMS ASSISTED.
p.001531: (a) ROUTINE NOTIFICATION OF DESIGNATED OFFICER.—
p.001531: (1) DETERMINATION BY TREATING FACILITY.—If a victim of an emergency is transported by emergency response
p.001531: employees to a medical facility and the medical facility makes a deter- mination that the victim has an
p.001531: airborne infectious disease,
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001531: Sec. 2695B PUBLIC HEALTH SERVICE ACT 1532
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p.001531: the medical facility shall notify the designated officer of the emergency response employees who
p.001531: transported the victim to the medical facility of the determination.
p.001531: (2) DETERMINATION BY FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim of an emergency is transported
p.001531: by emer- gency response employees to a medical facility and the victim dies at or before reaching the
p.001531: medical facility, the medical fa- cility ascertaining the cause of death shall notify the des- ignated
p.001531: officer of the emergency response employees who trans- ported the victim to the initial medical facility of
p.001531: any deter- mination by the medical facility that the victim had an air- borne infectious disease.
p.001531: (b) REQUIREMENT OF PROMPT NOTIFICATION.—With respect to a determination described in paragraph (1) or (2) of
p.001531: subsection (a), the notification required in each of such paragraphs shall be made as soon as is practicable, but not
p.001531: later than 48 hours after the de- termination is made.
p.001531: SEC. 2695B. ø300ff–133¿ REQUEST FOR NOTIFICATION WITH RESPECT TO VICTIMS ASSISTED.
p.001531: (a) INITIATION OF PROCESS BY EMPLOYEE.—If an emergency re- sponse employee believes that the employee may
p.001531: have been ex- posed to an infectious disease by a victim of an emergency who was transported to a medical facility as
p.001531: a result of the emergency, and if the employee attended, treated, assisted, or transported the vic- tim
p.001531: pursuant to the emergency, then the designated officer of the employee shall, upon the request of the
p.001531: employee, carry out the du- ties described in subsection (b) regarding a determination of wheth- er the employee may
p.001531: have been exposed to an infectious disease by the victim.
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p.001533: of appropriate facts; and
p.001533: (ii) if sufficient facts are obtained by the des- ignated officer—
p.001533: (I) the public health officer shall, on behalf of the designated officer involved, resubmit the re- quest to the
p.001533: medical facility; and
p.001533: (II) the medical facility shall provide to the designated officer the appropriate response under subsection
p.001533: (c).
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: 1535
p.001535: PUBLIC HEALTH SERVICE ACT
p.001535: Sec. 2695E
p.001535:
p.001535: SEC. 2695C. ø300ff–134¿ PROCEDURES FOR NOTIFICATION OF EXPO- SURE.
p.001535: (a) CONTENTS OF NOTIFICATION TO OFFICER.—In making a no- tification required under section 2695A or section
p.001535: 2695B(d)(2), a medical facility shall provide—
p.001535: (1) the name of the infectious disease involved; and
p.001535: (2) the date on which the victim of the emergency involved was transported by emergency response employees to the med-
p.001535: ical facility involved.
p.001535: (b) MANNER OF NOTIFICATION.—If a notification under section 2695A or section 2695B(d)(2) is mailed or
p.001535: otherwise indirectly made—
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p.001535: (1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer
p.001535: to whom the notification is sent of the fact that the notification has been sent; and
p.001535: (2) such designated officer shall, not later than 10 days after being informed by the medical facility
p.001535: that the notifica- tion has been sent, inform such medical facility whether the designated officer has
p.001535: received the notification.
p.001535: SEC. 2695D. ø300ff–135¿ NOTIFICATION OF EMPLOYEE.
p.001535: (a) IN GENERAL.—After receiving a notification for purposes of section 2695A or 2695B(d)(2), a designated officer of
p.001535: emergency re- sponse employees shall, to the extent practicable, immediately no- tify each of such employees
p.001535: who—
p.001535: (1) responded to the emergency involved; and
p.001535: (2) as indicated by guidelines developed by the Secretary, may have been exposed to an infectious disease.
p.001535: (b) CERTAIN CONTENTS OF NOTIFICATION TO EMPLOYEE.—A no- tification under this subsection to an emergency response
p.001535: employee shall inform the employee of—
p.001535: (1) the fact that the employee may have been exposed to an infectious disease and the name of the disease
p.001535: involved;
p.001535: (2) any action by the employee that, as indicated by guide- lines developed by the Secretary, is medically appropriate;
p.001535: and
p.001535: (3) if medically appropriate under such criteria, the date of such emergency.
p.001535: (c) RESPONSES OTHER THAN NOTIFICATION OF EXPOSURE.— After receiving a response under paragraph (3) or (4) of
p.001535: subsection
p.001535: (d) of section 2695B, or a response under subsection (g)(1) of such section, the designated officer for the
p.001535: employee shall, to the extent practicable, immediately inform the employee of the response.
p.001535: SEC. 2695E. ø300ff–136¿ SELECTION OF DESIGNATED OFFICERS.
p.001535: (a) IN GENERAL.—For the purposes of receiving notifications and responses and making requests under this
p.001535: part on behalf of emergency response employees, the public health officer of each State shall designate 1
p.001535: official or officer of each employer of emer- gency response employees in the State.
p.001535: (b) PREFERENCE IN MAKING DESIGNATIONS.—In making the designations required in subsection (a), a public health
p.001535: officer shall give preference to individuals who are trained in the provision of health care or in the
p.001535: control of infectious diseases.
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: Sec. 2695F PUBLIC HEALTH SERVICE ACT 1536
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p.001535: SEC. 2695F. ø300ff–137¿ LIMITATION WITH RESPECT TO DUTIES OF MEDICAL FACILITIES.
p.001535: The duties established in this part for a medical facility—
p.001535: (1) shall apply only to medical information possessed by the facility during the period in which the
p.001535: facility is treating the victim for conditions arising from the emergency, or during the 60-day period beginning
p.001535: on the date on which the victim is transported by emergency response employees to the facility, whichever period
p.001535: expires first; and
p.001535: (2) shall not apply to any extent after the expiration of the 30-day period beginning on the expiration of the
p.001535: applicable pe- riod referred to in paragraph (1), except that such duties shall apply with respect to any request
p.001535: under section 2695B(c) re- ceived by a medical facility before the expiration of such 30-day period.
p.001535: SEC. 2695G. ø300ff–138¿ MISCELLANEOUS PROVISIONS.
p.001535: (a) LIABILITY OF MEDICAL FACILITIES, DESIGNATED OFFICERS, PUBLIC HEALTH OFFICERS, AND GOVERNING
p.001535: ENTITIES.—This part may not be construed to authorize any cause of action for damages or any civil penalty against any
p.001535: medical facility, any designated of- ficer, any other public health officer, or any governing entity of such
p.001535: facility or officer for failure to comply with the duties estab- lished in this part.
p.001535: (b) TESTING.—This part may not, with respect to victims of emergencies, be construed to authorize or require a
p.001535: medical facility to test any such victim for any infectious disease.
p.001535: (c) CONFIDENTIALITY.—This part may not be construed to au- thorize or require any medical facility, any
p.001535: designated officer of emergency response employees, or any such employee, to disclose identifying information
p.001535: with respect to a victim of an emergency or with respect to an emergency response employee.
p.001535: (d) FAILURE TO PROVIDE EMERGENCY SERVICES.—This part may not be construed to authorize any emergency
p.001535: response em- ployee to fail to respond, or to deny services, to any victim of an emergency.
p.001535: (e) NOTIFICATION AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or
p.001535: partially as a result of a public health emergency that has been determined pursuant to section 319(a),
p.001535: individuals or public or private entities are un- able to comply with the requirements of this part,
p.001535: the Secretary may, notwithstanding any other provision of law, temporarily sus- pend, in whole or in part, the
p.001535: requirements of this part as the cir- cumstances reasonably require. Before or promptly after such a
p.001535: suspension, the Secretary shall notify the Congress of such action and publish in the Federal Register a
p.001535: notice of the suspension.
p.001535: (f) CONTINUED APPLICATION OF STATE AND LOCAL LAW.—Noth- ing in this part shall be construed to limit the
p.001535: application of State or local laws that require the provision of data to public health au- thorities.
p.001535: SEC. 2695H. ø300ff–139¿ INJUNCTIONS REGARDING VIOLATION OF PRO- HIBITION.
p.001535: (a) IN GENERAL.—The Secretary may, in any court of com- petent jurisdiction, commence a civil action for
p.001535: the purpose of ob-
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p.001537: 1537
p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
p.001537:
p.001537: taining temporary or permanent injunctive relief with respect to any violation of this part.
p.001537: (b) FACILITATION OF INFORMATION ON VIOLATIONS.—The Sec- retary shall establish an administrative process
p.001537: for encouraging emergency response employees to provide information to the Sec- retary regarding violations
p.001537: of this part. As appropriate, the Sec- retary shall investigate alleged such violations and seek appro-
p.001537: priate injunctive relief.
p.001537: SEC. 2695I. ø300ff–140¿ APPLICABILITY OF PART.
p.001537: This part shall not apply in a State if the chief executive officer of the State certifies to the Secretary that
p.001537: the law of the State is substantially consistent with this part.
p.001537: TITLE XXVII—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
p.001537:
p.001537: PART A—INDIVIDUAL AND GROUP MARKET REFORMS
p.001537: Subpart I—General Reform
p.001537: SEC. 2701. ø300gg¿ FAIR HEALTH INSURANCE PREMIUMS.
p.001537: (a) 1 PROHIBITING DISCRIMINATORY PREMIUM RATES.—
p.001537: (1) IN GENERAL.—With respect to the premium rate charged by a health insurance issuer for health
p.001537: insurance cov- erage offered in the individual or small group market—
p.001537: (A) such rate shall vary with respect to the particular plan or coverage involved only by—
p.001537: (i) whether such plan or coverage covers an indi- vidual or family;
p.001537: (ii) rating area, as established in accordance with paragraph (2);
p.001537: (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with
p.001537: section 2707(c)); and
p.001537: (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
p.001537: (B) such rate shall not vary with respect to the par- ticular plan or coverage involved by any other
p.001537: factor not described in subparagraph (A).
p.001537: (2) RATING AREA.—
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p.001537: (B) within the service area of such plan, deny such coverage to such employers and individuals if the
p.001537: issuer has demonstrated, if required, to the applicable State au- thority that—
p.001537: (i) it will not have the capacity to deliver services adequately to enrollees of any additional groups or any
p.001537: additional individuals because of its obligations to ex- isting group contract holders and enrollees, and
p.001537: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001539: 1539
p.001539: PUBLIC HEALTH SERVICE ACT
p.001539: Sec. 2703
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p.001539: (ii) it is applying this paragraph uniformly to all employers and individuals without regard to the
p.001539: claims experience of those individuals, employers and their employees (and their dependents) or any health
p.001539: status-related factor relating to such individuals em- ployees and dependents.
p.001539: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—An issuer, upon denying health insurance coverage in any
p.001539: service area in accordance with paragraph (1)(B), may not offer cov- erage in the group or individual
p.001539: market within such service area for a period of 180 days after the date such coverage is denied.
p.001539: (d) APPLICATION OF FINANCIAL CAPACITY LIMITS.—
p.001539: (1) IN GENERAL.—A health insurance issuer may deny health insurance coverage in the group or individual market
p.001539: if the issuer has demonstrated, if required, to the applicable State authority that—
p.001539: (A) it does not have the financial reserves necessary to underwrite additional coverage; and
p.001539: (B) it is applying this paragraph uniformly to all em- ployers and individuals in the group or
p.001539: individual market in the State consistent with applicable State law and with- out regard to the claims experience
p.001539: of those individuals, employers and their employees (and their dependents) or any health status-related
p.001539: factor relating to such individ- uals, employees and dependents.
p.001539: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—A health insurance issuer upon denying health
p.001539: insurance cov- erage in connection with group health plans in accordance with paragraph (1) in a State may not
p.001539: offer coverage in connection with group health plans in the group or individual market in the State for a
p.001539: period of 180 days after the date such coverage is denied or until the issuer has demonstrated to the applicable State
p.001539: authority, if required under applicable State law, that the issuer has sufficient financial reserves to
p.001539: underwrite addi- tional coverage, whichever is later. An applicable State author- ity may provide for the application
p.001539: of this subsection on a serv- ice-area-specific basis.
p.001539: SEC. 2703. ø300gg–2¿ GUARANTEED RENEWABILITY OF COVERAGE.
p.001539: (a) IN GENERAL.—Except as provided in this section, if a health insurance issuer offers health insurance coverage in
p.001539: the individual or group market, the issuer must renew or continue in force such coverage at the option of
p.001539: the plan sponsor or the individual, as ap- plicable.
p.001539: (b) GENERAL EXCEPTIONS.—A health insurance issuer may nonrenew or discontinue health insurance
p.001539: coverage offered in con- nection with a health insurance coverage offered in the group or in- dividual market based
p.001539: only on one or more of the following:
p.001539: (1) NONPAYMENT OF PREMIUMS.—The plan sponsor, or indi- vidual, as applicable, has failed to pay premiums or
p.001539: contribu- tions in accordance with the terms of the health insurance cov- erage or the issuer has not received timely
p.001539: premium payments.
p.001539: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001539:
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p.001547: becomes eligible for assistance, with respect to cov- erage under the group health plan or health insurance
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p.001547: Sec. 2704 PUBLIC HEALTH SERVICE ACT 1548
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p.001547: January 30, 2020
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p.001547: coverage, under such Medicaid plan or State child health plan (including under any waiver or demonstra- tion
p.001547: project conducted under or in relation to such a plan), if the employee requests coverage under the
p.001547: group health plan or health insurance coverage not later than 60 days after the date the employee or
p.001547: de- pendent is determined to be eligible for such assist- ance.
p.001547: (B) COORDINATION WITH MEDICAID AND CHIP.—
p.001547: (i) OUTREACH TO EMPLOYEES REGARDING AVAIL- ABILITY OF MEDICAID AND CHIP COVERAGE.—
p.001547: (I) IN GENERAL.—Each employer that main- tains a group health plan in a State that provides medical assistance
p.001547: under a State Medicaid plan under title XIX of the Social Security Act, or child health assistance under a
p.001547: State child health plan under title XXI of such Act, in the form of pre- mium assistance for the
p.001547: purchase of coverage under a group health plan, shall provide to each employee a written notice informing
p.001547: the employee of potential opportunities then currently available in the State in which the employee resides for pre-
p.001547: mium assistance under such plans for health cov- erage of the employee or the employee’s depend- ents. For
p.001547: purposes of compliance with this sub- clause, the employer may use any State-specific model notice developed
p.001547: in accordance with section 701(f)(3)(B)(i)(II) of the Employee Retirement In- come Security Act of
p.001547: 1974 (29 U.S.C. 1181(f)(3)(B)(i)(II)).
p.001547: (II) OPTION TO PROVIDE CONCURRENT WITH PROVISION OF PLAN MATERIALS TO EMPLOYEE.—An
p.001547: employer may provide the model notice applicable to the State in which an employee resides concur- rent with the
p.001547: furnishing of materials notifying the employee of health plan eligibility, concurrent with materials
p.001547: provided to the employee in con- nection with an open season or election process conducted under the
p.001547: plan, or concurrent with the furnishing of the summary plan description as provided in section 104(b) of the
p.001547: Employee Retire- ment Income Security Act of 1974.
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p.001553: the requirements of paragraph (3) if participation in the pro- gram is made available to all similarly
p.001553: situated individuals:
p.001553: (A) A program that reimburses all or part of the cost for memberships in a fitness center.
p.001553: (B) A diagnostic testing program that provides a re- ward for participation and does not base any part
p.001553: of the reward on outcomes.
p.001553: (C) A program that encourages preventive care related to a health condition through the waiver of the copayment or
p.001553: deductible requirement under group health plan for the costs of certain items or services related to a health condi-
p.001553: tion (such as prenatal care or well-baby visits).
p.001553: (D) A program that reimburses individuals for the costs of smoking cessation programs without regard to
p.001553: whether the individual quits smoking.
p.001553: (E) A program that provides a reward to individuals for attending a periodic health education seminar.
p.001553: (3) WELLNESS PROGRAMS SUBJECT TO REQUIREMENTS.—If any of the conditions for obtaining a premium discount,
p.001553: rebate, or reward under a wellness program as described in paragraph (1)(C) is based on an individual satisfying
p.001553: a standard that is related to a health status factor, the wellness program shall not violate this
p.001553: section if the following requirements are com- plied with:
p.001553: (A) The reward for the wellness program, together with the reward for other wellness programs with
p.001553: respect to the plan that requires satisfaction of a standard related to a health status factor, shall not exceed 30
p.001553: percent of the cost of employee-only coverage under the plan. If, in addi- tion to employees or individuals, any
p.001553: class of dependents (such as spouses or spouses and dependent children) may participate fully in the
p.001553: wellness program, such reward shall not exceed 30 percent of the cost of the coverage in which an
p.001553: employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of cov-
p.001553: erage shall be determined based on the total amount of employer and employee contributions for the benefit
p.001553: pack- age under which the employee is (or the employee and any dependents are) receiving coverage. A reward may
p.001553: be in the form of a discount or rebate of a premium or contribu-
p.001553: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001553:
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p.001553: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1554
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p.001555:
p.001555: wards provided under the project reflect the expected level of participation in the wellness program involved
p.001555: and the anticipated effect the program will have on utilization or medical claim costs.
p.001555: (m) REPORT.—
p.001555: (1) IN GENERAL.—Not later than 3 years after the date of enactment of the Patient Protection and
p.001555: Affordable Care Act, the Secretary, in consultation with the Secretary of the Treas- ury and the Secretary of
p.001555: Labor, shall submit a report to the appropriate committees of Congress concerning—
p.001555: (A) the effectiveness of wellness programs (as defined in subsection (j)) in promoting health and
p.001555: preventing dis- ease;
p.001555: (B) the impact of such wellness programs on the ac- cess to care and affordability of coverage for
p.001555: participants and non-participants of such programs;
p.001555: (C) the impact of premium-based and cost-sharing in- centives on participant behavior and the role of
p.001555: such pro- grams in changing behavior; and
p.001555: (D) the effectiveness of different types of rewards.
p.001555: (2) DATA COLLECTION.—In preparing the report described in paragraph (1), the Secretaries shall gather relevant
p.001555: informa- tion from employers who provide employees with access to wellness programs, including State and
p.001555: Federal agencies.
p.001555: (n) REGULATIONS.—Nothing in this section shall be construed as prohibiting the Secretaries of Labor,
p.001555: Health and Human Serv- ices, or the Treasury from promulgating regulations in connection with this section.
p.001555: SEC. 2706. ø300gg–5¿ NON-DISCRIMINATION IN HEALTH CARE.
p.001555: (a) PROVIDERS.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001555: coverage shall not discriminate with respect to participation under the plan or coverage against any health
p.001555: care provider who is acting within the scope of that provider’s license or certification under applicable State
p.001555: law. This section shall not require that a group health plan or health insurance issuer contract with
p.001555: any health care provider willing to abide by the terms and conditions for participation estab- lished by the plan
p.001555: or issuer. Nothing in this section shall be con- strued as preventing a group health plan, a health
p.001555: insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance
p.001555: measures.
p.001555: (b) INDIVIDUALS.—The provisions of section 1558 of the Patient Protection and Affordable Care Act (relating to
p.001555: non-discrimination) shall apply with respect to a group health plan or health insurance issuer offering group or
p.001555: individual health insurance coverage.
p.001555: SEC. 2707. ø300gg–6¿ COMPREHENSIVE HEALTH INSURANCE COV- ERAGE.
p.001555: (a) COVERAGE FOR ESSENTIAL HEALTH BENEFITS PACKAGE.—A health insurance issuer that offers health insurance
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p.001589: or any group health plan (and group health insurance coverage) in re- lation to its provision of excepted
p.001589: benefits described in section 27971(c)(4) if the benefits are provided under a separate policy, certificate, or
p.001589: contract of insurance.
p.001589: (d) TREATMENT OF PARTNERSHIPS.—For purposes of this part—
p.001589: (1) TREATMENT AS A GROUP HEALTH PLAN.—Any plan, fund, or program which would not be (but for this subsection) an
p.001589: em- ployee welfare benefit plan and which is established or main- tained by a partnership, to the extent that
p.001589: such plan, fund, or program provides medical care (including items and services paid for as medical care)
p.001589: to present or former partners in the partnership or to their dependents (as defined under the terms of the
p.001589: plan, fund, or program), directly or through insurance, reimbursement, or otherwise, shall be treated (subject
p.001589: to para- graph (2)) as an employee welfare benefit plan which is a group health plan.
p.001589: (2) EMPLOYER.—In the case of a group health plan, the term ‘‘employer’’ also includes the partnership in
p.001589: relation to any partner.
p.001589: (3) PARTICIPANTS OF GROUP HEALTH PLANS.—In the case of a group health plan, the term ‘‘participant’’ also includes—
p.001589: (A) in connection with a group health plan maintained by a partnership, an individual who is a partner in
p.001589: rela- tion to the partnership, or
p.001589: (B) in connection with a group health plan maintained by a self-employed individual (under which one or more
p.001589: employees are participants), the self-employed individual,
p.001589: if such individual is, or may become, eligible to receive a ben- efit under the plan or such individual’s
p.001589: beneficiaries may be el- igible to receive any such benefit.
p.001589: SEC. 2723. ø300gg–22¿ ENFORCEMENT.
p.001589: (a) STATE ENFORCEMENT.—
p.001589: (1) STATE AUTHORITY.—Subject to section 2723, each State may require that health insurance issuers that issue,
p.001589: sell, renew, or offer health insurance coverage in the State in the individual or group market meet the
p.001589: requirements of this part with respect to such issuers.
p.001589:
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p.001589: January 30, 2020
p.001589: 18 Section 1563 (relating to conforming amendments--originally designated as section 1562 and redesignated as section
p.001589: 1563 by section 10107(b)(1)) of Public Law 111–148 provides for an amendment to insert ‘‘or, with
p.001589: respect to individual coverage, under any health insurance cov- erage maintained by the same health insurance
p.001589: issuer’’. Such amendment did not specify where to insert this new language, however, it was carried out by inserting
p.001589: this new language before the period at the end in order to reflect the probable intent of Congress.
p.001589: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001611: State, the provisions of such part A shall apply.
p.001611: SEC. 2763. ø300gg–63¿ GENERAL EXCEPTIONS.
p.001611: (a) EXCEPTION FOR CERTAIN BENEFITS.—The requirements of this part shall not apply to any health insurance
p.001611: coverage in rela- tion to its provision of excepted benefits described in section 2791(c)(1).
p.001611: (b) EXCEPTION FOR CERTAIN BENEFITS IF CERTAIN CONDITIONS MET.—The requirements of this part shall not apply to
p.001611: any health insurance coverage in relation to its provision of excepted benefits described in paragraph (2),
p.001611: (3), or (4) of section 2791(c) if the bene- fits are provided under a separate policy, certificate, or contract of
p.001611: insurance.
p.001611: SEC. 2753. ø300gg–54¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE. 28
p.001611: The provisions of section 2707 shall apply to health insurance coverage offered by a health insurance
p.001611: issuer in the individual market in the same manner as they apply to health insurance cov- erage offered by a
p.001611: health insurance issuer in connection with a group health plan in the small or large group market.
p.001611: PART C—DEFINITIONS; MISCELLANEOUS PROVISIONS
p.001611: SEC. 2791. ø300gg–91¿ DEFINITIONS.
p.001611: (a) GROUP HEALTH PLAN.—
p.001611: (1) DEFINITION.—The term ‘‘group health plan’’ means an employee welfare benefit plan (as defined in section
p.001611: 3(1) of the Employee Retirement Income Security Act of 1974) to the ex- tent that the plan provides
p.001611: medical care (as defined in para- graph (2)) and including items and services paid for as medical care) to
p.001611: employees or their dependents (as defined under the terms of the plan) directly or through insurance,
p.001611: reimburse- ment, or otherwise. Except for purposes of part C of title XI of the Social Security Act (42 U.S.C.
p.001611: 1320d et seq.), such term shall not include any qualified small employer health reim- bursement arrangement
p.001611: (as defined in section 9831(d)(2) of the Internal Revenue Code of 1986).
p.001611: (2) MEDICAL CARE.—The term ‘‘medical care’’ means amounts paid for—
p.001611:
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p.001611: January 30, 2020
p.001611: Congress and in order to be consistent with the execution of different amendments made by such section
p.001611: 1563 to part A of this title (see details regarding the effective date in a note to a second version of
p.001611: part A).
p.001611: 28 The placement of section 2753 at the end of subpart 3 is so in law. See amendment made by section
p.001611: 2(b)(2) of Public Law 110–381 122 Stat. 4084). Section 102(b)(1)(A) of Public Law 110–233 redesignated
p.001611: subpart 3 of part B as subpart 2. Also, another section designated as sec- tion 2753 was added by section 102(b)(1)(B)
p.001611: of such Public Law (122 Stat. 893).
p.001611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001611: Sec. 2791 PUBLIC HEALTH SERVICE ACT 1612
p.001611: (A) the diagnosis, cure, mitigation, treatment, or pre- vention of disease, or amounts paid for the
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p.001613: (D) makes health insurance coverage offered through the association available to all members regardless of any
p.001613: health status-related factor relating to such members (or individuals eligible for coverage through a member);
p.001613: (E) does not make health insurance coverage offered through the association available other than in connection
p.001613: with a member of the association; and
p.001613: (F) meets such additional requirements as may be im- posed under State law.
p.001613: (4) COBRA CONTINUATION PROVISION.—The term ‘‘COBRA continuation provision’’ means any of the following:
p.001613: (A) Section 4980B of the Internal Revenue Code of 1986, other than subsection (f)(1) of such section insofar as
p.001613: it relates to pediatric vaccines.
p.001613: (B) Part 6 of subtitle B of title I of the Employee Re- tirement Income Security Act of 1974, other
p.001613: than section 609 of such Act.
p.001613: (C) Title XXII of this Act.
p.001613: (5) EMPLOYEE.—The term ‘‘employee’’ has the meaning given such term under section 3(6) of the Employee Retirement
p.001613: Income Security Act of 1974.
p.001613: (6) EMPLOYER.—The term ‘‘employer’’ has the meaning given such term under section 3(5) of the Employee
p.001613: Retirement Income Security Act of 1974, except that such term shall in- clude only employers of two or more
p.001613: employees.
p.001613: (7) CHURCH PLAN.—The term ‘‘church plan’’ has the mean- ing given such term under section 3(33) of the
p.001613: Employee Re- tirement Income Security Act of 1974.
p.001613: (8) GOVERNMENTAL PLAN.—(A) The term ‘‘governmental plan’’ has the meaning given such term under section
p.001613: 3(32) of the Employee Retirement Income Security Act of 1974 and any Federal governmental plan.
p.001613: (B) FEDERAL GOVERNMENTAL PLAN.—The term ‘‘Federal governmental plan’’ means a governmental plan established or
p.001613: maintained for its employees by the Government of the United States or by any agency or instrumentality of such
p.001613: Govern- ment.
p.001613: (C) NON-FEDERAL GOVERNMENTAL PLAN.—The term ‘‘non- Federal governmental plan’’ means a governmental plan
p.001613: that is not a Federal governmental plan.
p.001613: (9) HEALTH STATUS-RELATED FACTOR.—The term ‘‘health status-related factor’’ means any of the factors described
p.001613: in sec- tion 2702(a)(1).
p.001613: (10) NETWORK PLAN.—The term ‘‘network plan’’ means health insurance coverage of a health insurance
p.001613: issuer under which the financing and delivery of medical care (including items and services paid for as
p.001613: medical care) are provided, in whole or in part, through a defined set of providers under con- tract with the
p.001613: issuer.
p.001613: (11) PARTICIPANT.—The term ‘‘participant’’ has the mean- ing given such term under section 3(7) of the Employee
p.001613: Retire- ment Income Security Act of 1974.
p.001613: (12) PLACED FOR ADOPTION DEFINED.—The term ‘‘place- ment’’, or being ‘‘placed’’, for adoption, in
p.001613: connection with any
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001615: PUBLIC HEALTH SERVICE ACT
p.001615: Sec. 2791
p.001615:
p.001615: placement for adoption of a child with any person, means the assumption and retention by such person of
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p.001615: (19) UNDERWRITING PURPOSES.—The term ‘‘underwriting purposes’’ means, with respect to any group health
p.001615: plan, or health insurance coverage offered in connection with a group health plan—
p.001615: (A) rules for, or determination of, eligibility (including enrollment and continued eligibility) for benefits under the
p.001615: plan or coverage;
p.001615: (B) the computation of premium or contribution amounts under the plan or coverage;
p.001615: (C) the application of any pre-existing condition exclu- sion under the plan or coverage; and
p.001615: (D) other activities related to the creation, renewal, or replacement of a contract of health insurance or
p.001615: health benefits.
p.001615: (20) QUALIFIED HEALTH PLAN.—The term ‘‘qualified health plan’’ has the meaning given such term in section
p.001615: 1301(a) of the Patient Protection and Affordable Care Act.
p.001615: (21) EXCHANGE.—The term ‘‘Exchange’’ means an Amer- ican Health Benefit Exchange established under section
p.001615: 1311 of the Patient Protection and Affordable Care Act.
p.001615: (e) DEFINITIONS RELATING TO MARKETS AND SMALL EMPLOY-
p.001615: ERS.—For purposes of this title:
p.001615: (1) INDIVIDUAL MARKET.—
p.001615: (A) IN GENERAL.—The term ‘‘individual market’’ means the market for health insurance coverage offered to indi-
p.001615: viduals other than in connection with a group health plan.
p.001615: (B) TREATMENT OF VERY SMALL GROUPS.—
p.001615: (i) IN GENERAL.—Subject to clause (ii), such terms includes coverage offered in connection with a group health
p.001615: plan that has fewer than two participants as current employees on the first day of the plan year.
p.001615: (ii) STATE EXCEPTION.—Clause (i) shall not apply in the case of a State that elects to regulate the
p.001615: cov- erage described in such clause as coverage in the small group market.
p.001615: (2) LARGE EMPLOYER.—The term ‘‘large employer’’ means, in connection with a group health plan with
p.001615: respect to a cal- endar year and a plan year, an employer who employed an av- erage of at least 51 employees on
p.001615: business days during the pre- ceding calendar year and who employs at least 2 employees on the first day of the plan
p.001615: year.
p.001615: (3) LARGE GROUP MARKET.—The term ‘‘large group market’’ means the health insurance market under which
p.001615: individuals obtain health insurance coverage (directly or through any ar- rangement) on behalf of
p.001615: themselves (and their dependents) through a group health plan maintained by a large employer.
p.001615: (4) SMALL EMPLOYER.—The term ‘‘small employer’’ means, in connection with a group health plan with
p.001615: respect to a cal- endar year and a plan year, an employer who employed an av- erage of at least 1 but not more than
p.001615: 50 employees on business
p.001615: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001617: PUBLIC HEALTH SERVICE ACT
p.001617: Sec. 2793
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p.001617: days during the preceding calendar year and who employs at least 1 employees on the first day of the plan
p.001617: year.
p.001617: (5) SMALL GROUP MARKET.—The term ‘‘small group mar- ket’’ means the health insurance market under which
p.001617: individ- uals obtain health insurance coverage (directly or through any arrangement) on behalf of themselves (and
p.001617: their dependents) through a group health plan maintained by a small employer.
p.001617: (6) APPLICATION OF CERTAIN RULES IN DETERMINATION OF EMPLOYER SIZE.—For purposes of this subsection—
p.001617: (A) APPLICATION OF AGGREGATION RULE FOR EMPLOY- ERS.—all persons treated as a single employer under sub-
p.001617: section (b), (c), (m), or (o) of section 414 of the Internal Revenue Code of 1986 shall be treated as 1
p.001617: employer.
p.001617: (B) EMPLOYERS NOT IN EXISTENCE IN PRECEDING YEAR.—In the case of an employer which was not in exist-
p.001617: ence throughout the preceding calendar year, the deter- mination of whether such employer is a small or large
p.001617: em- ployer shall be based on the average number of employees that it is reasonably expected such employer will
p.001617: employ on business days in the current calendar year.
p.001617: (C) PREDECESSORS.—Any reference in this subsection to an employer shall include a reference to any predecessor
p.001617: of such employer.
p.001617: (7) STATE OPTION TO EXTEND DEFINITION OF SMALL EM- PLOYER.—Notwithstanding paragraphs (2) and (4),
p.001617: nothing in this section shall prevent a State from applying this subsection by treating as a small employer,
p.001617: with respect to a calendar year and a plan year, an employer who employed an average of at least 1 but
p.001617: not more than 100 employees on business days during the preceding calendar year and who employs at least 1
p.001617: employee on the first day of the plan year.
p.001617: SEC. 2792. ø300gg–92¿ REGULATIONS.
p.001617: The Secretary, consistent with section 104 of the Health Care Portability and Accountability Act of 1996,
p.001617: may promulgate such regulations as may be necessary or appropriate to carry out the provisions of this
p.001617: title. The Secretary may promulgate any interim final rules as the Secretary determines are appropriate to carry out
p.001617: this title.
p.001617: SEC. 2793. ø300gg–93¿ HEALTH INSURANCE CONSUMER INFORMATION.
p.001617: (a) IN GENERAL.—The Secretary shall award grants to States to enable such States (or the Exchanges
p.001617: operating in such States) to establish, expand, or provide support for—
p.001617: (1) offices of health insurance consumer assistance; or
p.001617: (2) health insurance ombudsman programs.
p.001617: (b) ELIGIBILITY.—
p.001617: (1) IN GENERAL.—To be eligible to receive a grant, a State shall designate an independent office of health
p.001617: insurance con- sumer assistance, or an ombudsman, that, directly or in coordi- nation with State health insurance
p.001617: regulators and consumer assistance organizations, receives and responds to inquiries and complaints
p.001617: concerning health insurance coverage with re- spect to Federal health insurance requirements and under
p.001617: State law.
p.001617: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001617:
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p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
p.001645:
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p.001645: January 30, 2020
p.001645: 2 So in law. Probably should read ‘‘the Administrator’’.
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645:
p.001647: 1647
p.001647: PUBLIC HEALTH SERVICE ACT
p.001647: Sec. 2822
p.001647:
p.001647: Subtitle C—Strengthening Public Health Surveillance Systems
p.001647:
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p.001663: 1663
p.001663: PUBLIC HEALTH SERVICE ACT
p.001663: Sec. 3002
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p.001663: January 30, 2020
p.001663: to avoid the disruption of existing exchanges between participants of health information networks.
p.001663: (iv) APPLICATION BY FEDERAL AGENCIES.—Notwith- standing clauses (i), (ii), and (iii), Federal agencies may
p.001663: require the adoption of the trusted exchange framework and common agreement published under
p.001663: subparagraph (C) for health information exchanges contracting with or entering into agreements pursuant to
p.001663: subparagraph (E).
p.001663: (v) CONSIDERATION OF ONGOING WORK.—In car- rying out this paragraph, the Secretary shall ensure the
p.001663: consideration of activities carried out by public and private organizations related to exchange between health
p.001663: information exchanges to avoid duplication of efforts.
p.001663: (d) DETAIL OF FEDERAL EMPLOYEES.—
p.001663: (1) IN GENERAL.—Upon the request of the National Coordi- nator, the head of any Federal agency is authorized
p.001663: to detail, with or without reimbursement from the Office, any of the per- sonnel of such agency to the Office to
p.001663: assist it in carrying out its duties under this section.
p.001663: (2) EFFECT OF DETAIL.—Any detail of personnel under paragraph (1) shall—
p.001663: (A) not interrupt or otherwise affect the civil service status or privileges of the Federal employee; and
p.001663: (B) be in addition to any other staff of the Department employed by the National Coordinator.
p.001663: (3) ACCEPTANCE OF DETAILEES.—Notwithstanding any other provision of law, the Office may accept detailed
p.001663: personnel from other Federal agencies without regard to whether the agency described under paragraph (1) is
p.001663: reimbursed.
p.001663: (e) CHIEF PRIVACY OFFICER OF THE OFFICE OF THE NATIONAL COORDINATOR.—Not later than 12 months after the date
p.001663: of the en- actment of this title, the Secretary shall appoint a Chief Privacy Officer of the Office of
p.001663: the National Coordinator, whose duty it shall be to advise the National Coordinator on privacy, security,
p.001663: and data stewardship of electronic health information and to co- ordinate with other Federal agencies
p.001663: (and similar privacy officers in such agencies), with State and regional efforts, and with foreign countries with
p.001663: regard to the privacy, security, and data steward- ship of electronic individually identifiable health
p.001663: information.
p.001663: SEC. 3002. ø300jj–12¿ HEALTH INFORMATION TECHNOLOGY ADVISORY COMMITTEE.
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p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
p.001697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001699: 1699
p.001699: PUBLIC HEALTH SERVICE ACT
p.001699: Sec. 3101
p.001699:
p.001699: (A) develop national standards for the management of data collected; and
p.001699: (B) develop interoperability and security systems for data management.
p.001699: (b) 1 DATA ANALYSIS.—
p.001699: (1) IN GENERAL.—For each federally conducted or sup- ported health care or public health program or
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p.001699: January 30, 2020
p.001699: SEC. 3301. ø42 U.S.C. 300mm¿ ESTABLISHMENT OF WORLD TRADE CEN- TER HEALTH PROGRAM.
p.001699: (a) IN GENERAL.—There is hereby established within the De- partment of Health and Human Services a
p.001699: program to be known as the World Trade Center Health Program, which shall be admin-
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001701: PUBLIC HEALTH SERVICE ACT
p.001701: Sec. 3301
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p.001701: January 30, 2020
p.001701: istered by the WTC Program Administrator, to provide beginning on July 1, 2011—
p.001701: (1) medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup
p.001701: workers (in- cluding those who are Federal employees) who responded to the September 11, 2001, terrorist
p.001701: attacks; and
p.001701: (2) initial health evaluation, monitoring, and treatment benefits to residents and other building occupants
p.001701: and area workers in New York City who were directly impacted and ad- versely affected by such attacks.
p.001701: (b) COMPONENTS OF PROGRAM.—The WTC Program includes the following components:
p.001701: (1) MEDICAL MONITORING FOR RESPONDERS.—Medical moni- toring under section 3311, including clinical examinations and
p.001701: long-term health monitoring and analysis for enrolled WTC re- sponders who were likely to have been exposed to airborne
p.001701: tox- ins that were released, or to other hazards, as a result of the September 11, 2001, terrorist attacks.
p.001701: (2) INITIAL HEALTH EVALUATION FOR SURVIVORS.—An ini- tial health evaluation under section 3321, including an
p.001701: evalua- tion to determine eligibility for followup monitoring and treat- ment.
p.001701: (3) FOLLOWUP MONITORING AND TREATMENT FOR WTC-RE- LATED HEALTH CONDITIONS FOR RESPONDERS AND
p.001701: SURVIVORS.—
p.001701: Provision under sections 3312, 3322, and 3323 of followup monitoring and treatment and payment, subject
p.001701: to the provi- sions of subsection (d), for all medically necessary health and mental health care expenses of
p.001701: an individual with respect to a WTC-related health condition (including necessary prescription drugs).
p.001701: (4) OUTREACH.—Establishment under section 3303 of an education and outreach program to potentially eligible
p.001701: individ- uals concerning the benefits under this title.
p.001701: (5) CLINICAL DATA COLLECTION AND ANALYSIS.—Collection and analysis under section 3304 of health and mental
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p.001705: January 30, 2020
p.001705: (A) WTC RESPONDERS STEERING COMMITTEE.—One Steering Committee, to be known as the WTC Responders Steering
p.001705: Committee, for the purpose of receiving input from affected stakeholders and facilitating the coordination of
p.001705: monitoring and treatment programs for the enrolled WTC responders under part 1 of subtitle B.
p.001705: (B) WTC SURVIVORS STEERING COMMITTEE.—One Steering Committee, to be known as the WTC Survivors
p.001705: Steering Committee, for the purpose of receiving input from affected stakeholders and facilitating the
p.001705: coordination of initial health evaluations, monitoring, and treatment programs for screening-eligible and
p.001705: certified-eligible WTC survivors under part 2 of subtitle B.
p.001705: (2) MEMBERSHIP.—
p.001705: (A) WTC RESPONDERS STEERING COMMITTEE.—
p.001705: (i) REPRESENTATION.—The WTC Responders Steering Committee shall include—
p.001705: (I) representatives of the Centers of Excel- lence providing services to WTC responders;
p.001705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001705:
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p.001705: Sec. 3303 PUBLIC HEALTH SERVICE ACT 1706
p.001705:
p.001705: (II) representatives of labor organizations rep- resenting firefighters, police, other New York City employees, and
p.001705: recovery and cleanup workers who responded to the September 11, 2001, terrorist at- tacks; and
p.001705: (III) 3 representatives of New York City, 1 of whom will be selected by the police commissioner of New
p.001705: York City, 1 by the health commissioner of New York City, and 1 by the mayor of New York City.
p.001705: (ii) INITIAL MEMBERSHIP.—The WTC Responders Steering Committee shall initially be composed of members
p.001705: of the WTC Monitoring and Treatment Pro- gram Steering Committee (as in existence on the day before the
p.001705: date of the enactment of this title).
p.001705: (B) WTC SURVIVORS STEERING COMMITTEE.—
p.001705: (i) REPRESENTATION.—The WTC Survivors Steer- ing Committee shall include representatives of—
p.001705: (I) the Centers of Excellence providing serv- ices to screening-eligible and certified-eligible WTC
p.001705: survivors;
p.001705: (II) the population of residents, students, and area and other workers affected by the September 11, 2001, terrorist
p.001705: attacks;
p.001705: (III) screening-eligible and certified-eligible survivors receiving initial health evaluations,
p.001705: monitoring, or treatment under part 2 of subtitle B and organizations advocating on their behalf; and
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p.001705: January 30, 2020
p.001705: (IV) New York City.
p.001705: (ii) INITIAL MEMBERSHIP.—The WTC Survivors Steering Committee shall initially be composed of
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p.001723: (including any prior authorization requirement), and a process for appeal of a determination under
p.001723: subsection (c)(3).
p.001723: (4) SCOPE OF TREATMENT COVERED.—
p.001723: (A) IN GENERAL.—The scope of treatment covered under this subsection includes services of physicians
p.001723: and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and
p.001723: outpatient hospital services, and other medically necessary treatment.
p.001723: (B) PHARMACEUTICAL COVERAGE.—With respect to en- suring coverage of medically necessary outpatient prescrip- tion
p.001723: drugs, such drugs shall be provided, under arrange- ments made by the WTC Program Administrator, directly
p.001723: through participating Clinical Centers of Excellence or through one or more outside vendors.
p.001723: (C) TRANSPORTATION EXPENSES FOR NATIONWIDE NET- WORK.—The WTC Program Administrator may provide for necessary and
p.001723: reasonable transportation and expenses in- cident to the securing of medically necessary treatment through
p.001723: the nationwide network under section 3313 in- volving travel of more than 250 miles and for which pay-
p.001723: ment is made under this section in the same manner in which individuals may be furnished necessary and
p.001723: reason- able transportation and expenses incident to services in- volving travel of more than 250 miles
p.001723: under regulations implementing section 3629(c) of the Energy Employees Oc- cupational Illness Compensation Program Act
p.001723: of 2000 (title XXXVI of Public Law 106–398; 42 U.S.C. 7384t(c)).
p.001723: (5) PROVISION OF TREATMENT PENDING CERTIFICATION.— With respect to an enrolled WTC responder for whom a deter-
p.001723: mination is made by an examining physician under paragraph
p.001723: (1) or (2), but for whom the WTC Program Administrator has not yet determined whether to certify the
p.001723: determination, the WTC Program Administrator may establish by rule a process through which the Administrator
p.001723: may approve the provision of medical treatment under this subsection (and payment under subsection (c)) with
p.001723: respect to such responder and such re- sponder’s WTC-related health condition (under such terms and conditions as
p.001723: the Administrator may provide) until the Admin- istrator makes a decision on whether to certify the determina- tion.
p.001723: (c) PAYMENT FOR INITIAL HEALTH EVALUATION, MONITORING,
p.001723: AND TREATMENT OF WTC-RELATED HEALTH CONDITIONS.—
p.001723: (1) MEDICAL TREATMENT.—
p.001723: (A) USE OF FECA PAYMENT RATES.—
p.001723: (i) IN GENERAL.—Subject to clause (ii):
p.001723: (I) Subject to subparagraphs (B) and (C), the WTC Program Administrator shall reimburse costs for
p.001723: medically necessary treatment under this title for WTC-related health conditions according to the payment rates
p.001723: that would apply to the pro- vision of such treatment and services by the facil- ity under the Federal Employees
p.001723: Compensation Act.
p.001723: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001723:
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p.001725: Sec. 3312
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p.001725: (II) For treatment not covered under sub- clause (i) or subparagraph (B), the WTC Program
p.001725: Administrator shall establish by regulation a re- imbursement rate for such treatment.
p.001725: (ii) EXCEPTION.—In no case shall payments for products or services under clause (i) be made at a rate higher than
p.001725: the Office of Worker’s Compensation Pro- grams in the Department Labor would pay for such products or
p.001725: services rendered at the time such prod- ucts or services were provided.
p.001725: (B) PHARMACEUTICALS.—
p.001725: (i) IN GENERAL.—The WTC Program Adminis- trator shall establish a program for paying for the
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p.000289: funded under the Maternal and Child Health Block Grant.
p.000289: (d) RULE OF CONSTRUCTION.—Except to the extent inconsistent with this section, this section may not be construed as
p.000289: affecting the authority of the Secretary to make modifications in the program carried out under subsection
p.000289: (a).
p.000289: (e) FUNDING.—
p.000289: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000289: be appro- priated—
p.000289: (A) $120,000,000 for fiscal year 2008; and
p.000289: (B) for each of fiscal years 2009 through 2013, the amount authorized for the preceding fiscal year
p.000289: increased by the percentage increase in the Consumer Price Index for all urban consumers for such year.
p.000289: (2) ALLOCATION.—
p.000289: (A) PROGRAM ADMINISTRATION.—Of the amounts ap- propriated under paragraph (1) for a fiscal year, the Sec-
p.000289: retary may reserve up to 5 percent for coordination, dis- semination, technical assistance, and data
p.000289: activities that are determined by the Secretary to be appropriate for car- rying out the program under this section.
p.000289: (B) EVALUATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve
p.000289: up to 1 percent for evaluations of projects carried out under subsection (a). Each such evaluation shall
p.000289: include a determination of whether such projects have been effective in reducing the disparity in health status between
p.000289: the gen- eral population and individuals who are members of racial or ethnic minority groups.
p.000289: SEC. 330I. ø254c–14¿ TELEHEALTH NETWORK AND TELEHEALTH RE- SOURCE CENTERS GRANT PROGRAMS.
p.000289: (a) DEFINITIONS.—In this section:
p.000289: (1) DIRECTOR; OFFICE.—The terms ‘‘Director’’ and ‘‘Office’’ mean the Director and Office specified in subsection
p.000289: (c).
p.000289: (2) FEDERALLY QUALIFIED HEALTH CENTER AND RURAL HEALTH CLINIC.—The term ‘‘Federally qualified
p.000289: health center’’ and ‘‘rural health clinic’’ have the meanings given the terms in section 1861(aa) of the
p.000289: Social Security Act (42 U.S.C. 1395x(aa)).
p.000289: (3) FRONTIER COMMUNITY.—The term ‘‘frontier community’’ shall have the meaning given the term in regulations
p.000289: issued under subsection (r).
p.000289: (4) MEDICALLY UNDERSERVED AREA.—The term ‘‘medically underserved area’’ has the meaning given the term
p.000289: ‘‘medically underserved community’’ in section 799B(6).
p.000289: (5) MEDICALLY UNDERSERVED POPULATION.—The term ‘‘medically underserved population’’ has the meaning given
p.000289: the term in section 330(b)(3).
p.000289: (6) TELEHEALTH SERVICES.—The term ‘‘telehealth services’’ means services provided through telehealth technologies.
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000291: PUBLIC HEALTH SERVICE ACT
p.000291: Sec. 330I
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p.000459: health emer- gencies that can damage marrow, so that the capability of supporting patients with marrow damage from
p.000459: disease can be used to support casualties with marrow damage;
p.000459: (E) carry out informational and educational activities in accordance with subsection (e);
p.000459: (F) at least annually update information to account for changes in the status of individuals as potential donors of
p.000459: bone marrow;
p.000459: (G) provide for a system of patient advocacy through the office established under subsection (h);
p.000459: (H) provide case management services for any poten- tial donor of bone marrow to whom the Program has
p.000459: pro- vided a notice that the potential donor may be suitably
p.000459:
p.000459: 84 Section 5 of Public Law 105–196 (112 Stat. 636) provides as follows:
p.000459:
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p.000459: January 30, 2020
p.000459:
p.000459: ‘‘SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.
p.000459: ‘‘(a) IN GENERAL.—During the period indicated pursuant to subsection (b), the Comptroller General of the
p.000459: United States shall conduct a study of the National Bone Marrow Donor Registry under section 379 of the Public
p.000459: Health Service Act for purposes of making determinations of the following:
p.000459: ‘‘(1) The extent to which, relative to the effective date of this Act, such Registry has in- creased
p.000459: the representation of racial and ethnic minority groups (including persons of mixed ancestry) among potential donors
p.000459: of bone marrow who are enrolled with the Registry, and whether the extent of increase results in a level of
p.000459: representation that meets the standard established in subsection (c)(1)(A) of such section 379 (as added by section
p.000459: 2(c) of this Act). ‘‘(2) The extent to which patients in need of a transplant of bone marrow from a
p.000459: bio- logically unrelated donor, and the physicians of such patients, have been utilizing the Reg-
p.000459: istry in the search for such a donor.
p.000459: ‘‘(3) The number of such patients for whom the Registry began a preliminary search but for whom the full search
p.000459: process was not completed, and the reasons underlying such cir- cumstances.
p.000459: ‘‘(4) The extent to which the plan required in section 2(b)(2) of this Act (relating to the
p.000459: relationship between the Registry and donor centers) has been implemented.
p.000459: ‘‘(5) The extent to which the Registry, donor centers, donor registries, collection centers, transplant
p.000459: centers, and other appropriate entities have been complying with the standards, criteria, and procedures under
p.000459: subsection (e) of such section 379 (as redesignated by section 2(c) of this Act).
p.000459: ‘‘(b) REPORT.—A report describing the findings of the study under subsection (a) shall be sub- mitted to the Congress
p.000459: not later than October 1, 2001. The report may not be submitted before January 1, 2001.’’.
p.000459: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: recommendations of the Task Force, ensuring ade- quate staff resources, and assistance to those
p.000553: organizations re- questing it for implementation of Guide recommendations.
p.000553: (d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE.— The Task Force shall take appropriate steps to coordinate
p.000553: its work with the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices,
p.000553: including the examination of how each task force’s recommendations interact at the nexus of clinic and
p.000553: community.
p.000553: (e) OPERATION.—In carrying out the duties under subsection (b), the Task Force shall not be subject to the
p.000553: provisions of Appen- dix 2 of title 5, United States Code.
p.000553: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary
p.000553: for each fiscal year to carry out the activities of the Task Force.
p.000553: SEC. 399V. ø280g–11¿ GRANTS TO PROMOTE POSITIVE HEALTH BEHAV- IORS AND OUTCOMES.
p.000553: (a) GRANTS AUTHORIZED.—The Director of the Centers for Dis- ease Control and Prevention, in collaboration with
p.000553: the Secretary, shall award grants to eligible entities to promote positive health behaviors and outcomes
p.000553: for populations in medically underserved communities through the use of community health workers.
p.000553: (b) USE OF FUNDS.—Grants awarded under subsection (a) shall be used to support community health workers—
p.000553: (1) to educate, guide, and provide outreach in a community setting regarding health problems prevalent in
p.000553: medically un- derserved communities, particularly racial and ethnic minority populations;
p.000553: (2) to educate and provide guidance regarding effective strategies to promote positive health behaviors and
p.000553: discourage risky health behaviors;
p.000553: (3) to educate and provide outreach regarding enrollment in health insurance including the Children’s Health
p.000553: Insurance Program under title XXI of the Social Security Act, Medicare under title XVIII of such Act and
p.000553: Medicaid under title XIX of such Act;
p.000553: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000555: 555
p.000555: PUBLIC HEALTH SERVICE ACT
p.000555: Sec. 399V
p.000555:
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p.000555: January 30, 2020
p.000555: (4) to identify and refer underserved populations to appro- priate healthcare agencies and community-based programs and
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p.000759: (c) MINORITY HEALTH DISPARITIES RESEARCH.—For purposes of this subpart:
p.000759: (1) The term ‘‘minority health disparities research’’ means basic, clinical, and behavioral research on minority health
p.000759: con- ditions (as defined in paragraph (2)), including research to pre- vent, diagnose, and treat such conditions.
p.000759: (2) The term ‘‘minority health conditions’’, with respect to individuals who are members of minority
p.000759: groups, means all diseases, disorders, and conditions (including with respect to mental health and substance
p.000759: abuse)—
p.000759: (A) unique to, more serious, or more prevalent in such individuals;
p.000759: (B) for which the factors of medical risk or types of medical intervention may be different for such
p.000759: individuals, or for which it is unknown whether such factors or types are different for such individuals; or
p.000759: (C) with respect to which there has been insufficient research involving such individuals as subjects or
p.000759: insuffi- cient data on such individuals.
p.000759: (3) The term ‘‘minority group’’ has the meaning given the term ‘‘racial and ethnic minority group’’ in section
p.000759: 1707.
p.000759: (4) The terms ‘‘minority’’ and ‘‘minorities’’ refer to individ- uals from a minority group.
p.000759: (d) HEALTH DISPARITY POPULATIONS.—For purposes of this subpart:
p.000759:
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p.000759: January 30, 2020
p.000759: (1) A population is a health disparity population if, as de- termined by the Director of the Institute after
p.000759: consultation with the Director of the Agency for Healthcare Research and Quality, there is a significant
p.000759: disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the
p.000759: population as compared to the health status of the general population.
p.000759: (2) The Director shall give priority consideration to deter- mining whether minority groups qualify as
p.000759: health disparity populations under paragraph (1).
p.000759: (3) The term ‘‘health disparities research’’ means basic, clinical, and behavioral research on health
p.000759: disparity popu- lations (including individual members and communities of such populations) that relates to health
p.000759: disparities as defined under paragraph (1), including the causes of such disparities and methods to prevent,
p.000759: diagnose, and treat such disparities.
p.000759: (e) COORDINATION OF ACTIVITIES.—The Director of the Institute shall act as the primary Federal official with
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p.000949: substantially equivalent to the content provided by nonreligious organizations that the State or local
p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
p.000949:
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
p.000951:
p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
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p.001083: or professional counseling.
p.001083: (23) ONE-STOP DELIVERY SYSTEM CENTER.—The term ‘‘one- stop delivery system’’ means a 26one-stop delivery
p.001083: system de- scribed in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C. 2864(c)).
p.001083: (24) PARAPROFESSIONAL CHILD AND ADOLESCENT MENTAL HEALTH WORKER.—The term ‘‘paraprofessional child and
p.001083: ado- lescent mental health worker’’ means an individual who is not a mental or behavioral health service
p.001083: professional, but who works at the first stage of contact with children and families who are seeking
p.001083: mental or behavioral health services, includ- ing substance abuse prevention and treatment services.
p.001083: (25) RACIAL AND ETHNIC MINORITY GROUP; RACIAL AND ETH- NIC MINORITY POPULATION.—The terms ‘‘racial and
p.001083: ethnic mi- nority group’’ and ‘‘racial and ethnic minority population’’ have the meaning given the term ‘‘racial and
p.001083: ethnic minority group’’ in section 1707.
p.001083: (26) RURAL HEALTH CLINIC.—The term ‘‘rural health clinic’’ has the meaning given that term in section 1861(aa) of the
p.001083: So- cial Security Act (42 U.S.C. 1395x(aa)).
p.001083:
p.001083: TITLE VIII—NURSING WORKFORCE DEVELOPMENT
p.001083: PART A—GENERAL PROVISIONS
p.001083: SEC. 801. ø296¿ DEFINITIONS.
p.001083: As used in this title:
p.001083: (1) ELIGIBLE ENTITIES.—The term ‘‘eligible entities’’ means schools of nursing, nursing centers, academic health
p.001083: centers, State or local governments, and other public or private non- profit entities determined
p.001083: appropriate by the Secretary that submit to the Secretary an application in accordance with sec- tion 802.
p.001083:
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p.001083:
p.001083: January 30, 2020
p.001083: 26 Effective on July 1, 2015, section 512(z)(3) of Public Law 113–128 provides for an amend- ment to
p.001083: strike ‘‘one-stop delivery system described in section 134(c) of the Workforce Investment Act of 1998 (29 U.S.C.
p.001083: 2864(c))’’ and insert ‘‘one-stop delivery system described in section 121(e) of the Workforce Innovation and
p.001083: Opportunity Act’’.
p.001083: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001083: Sec. 801 PUBLIC HEALTH SERVICE ACT 1084
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p.001115: in providing cul- turally competent health services to minority health disparity populations or other health
p.001115: disparity populations. In exam- ining such practices of providers funded under the authorities of this Act,
p.001115: the Director shall consult with the heads of the rel- evant agencies of the Public Health Service.
p.001115: (3) REPORT.—Not later than 36 months after the date of the enactment of this section, the Secretary, acting
p.001115: through the Director, shall prepare and submit to the appropriate commit- tees of Congress a report describing the
p.001115: state-of-the-art of qual- ity measurement for minority and other health disparity popu- lations that will identify
p.001115: critical unmet needs, the current ac- tivities of the Department to address those needs, and a de-
p.001115: scription of related activities in the private sector.
p.001115: (d) DEFINITION.—For purposes of this section:
p.001115: (1) The term ‘‘health disparity population’’ has the mean- ing given such term in section 464z–3, except that
p.001115: in addition to the meaning so given, the Director may determine that such term includes populations for which
p.001115: there is a significant dis- parity in the quality, outcomes, cost, or use of health care serv- ices or access to or
p.001115: satisfaction with such services as compared to the general population.
p.001115: (2) The term ‘‘minority’’, with respect to populations, refers to racial and ethnic minority groups as defined in
p.001115: section 1707.
p.001115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001117: PUBLIC HEALTH SERVICE ACT
p.001117: Sec. 912
p.001117:
p.001117: PART B—HEALTH CARE IMPROVEMENT RESEARCH
p.001117: SEC. 911. ø299b¿ HEALTH CARE OUTCOME IMPROVEMENT RESEARCH.
p.001117: (a) EVIDENCE RATING SYSTEMS.—In collaboration with experts from the public and private sector, the Agency
p.001117: shall identify and disseminate methods or systems to assess health care research re- sults, particularly methods
p.001117: or systems to rate the strength of the scientific evidence underlying health care practice, recommenda-
p.001117: tions in the research literature, and technology assessments. The Agency shall make methods or systems
p.001117: for evidence rating widely available. Agency publications containing health care recommenda- tions shall indicate
p.001117: the level of substantiating evidence using such methods or systems.
p.001117: (b) HEALTH CARE IMPROVEMENT RESEARCH CENTERS AND PRO-
p.001117: VIDER-BASED RESEARCH NETWORKS.—
p.001117: (1) IN GENERAL.—In order to address the full continuum of care and outcomes research, to link research to
p.001117: practice im- provement, and to speed the dissemination of research findings to community practice settings, the
p.001117: Agency shall employ re- search strategies and mechanisms that will link research di- rectly with clinical
p.001117: practice in geographically diverse locations throughout the United States, including—
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p.001275: PUBLIC HEALTH SERVICE ACT
p.001275: Sec. 1707
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p.001275: January 30, 2020
p.001275: decreasing disparities in health care outcomes, including cul- tural competency as a method of eliminating
p.001275: health disparities.
p.001275: (c) ADVISORY COMMITTEE.—
p.001275: (1) IN GENERAL.—The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority
p.001275: Health (in this subsection referred to as the ‘‘Committee’’).
p.001275: (2) DUTIES.—The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section,
p.001275: including advice on the development of goals and specific program activi- ties under paragraphs (1) through (10)
p.001275: of subsection (b) for each racial and ethnic minority group.
p.001275: (3) CHAIR.—The chairperson of the Committee shall be se- lected by the Secretary from among the members of the voting
p.001275: members of the Committee. The term of office of the chair- person shall be 2 years.
p.001275: (4) COMPOSITION.—
p.001275: (A) The Committee shall be composed of 12 voting members appointed in accordance with subparagraph (B),
p.001275: and nonvoting, ex officio members designated in subpara- graph (C).
p.001275: (B) The voting members of the Committee shall be ap- pointed by the Secretary from among individuals who are
p.001275: not officers or employees of the Federal Government and who have expertise regarding issues of minority
p.001275: health. The racial and ethnic minority groups shall be equally rep- resented among such members.
p.001275: (C) The nonvoting, ex officio members of the Com- mittee shall be such officials of the Department of
p.001275: Health and Human Services as the Secretary determines to be ap- propriate.
p.001275: (5) TERMS.—Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall
p.001275: initially ap- point a portion of the members to terms of 1 year, 2 years, and 3 years.
p.001275: (6) VACANCIES.—If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary
p.001275: within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which the
p.001275: predecessor of such mem- ber was appointed. The vacancy shall not affect the power of the remaining members
p.001275: to execute the duties of the Com- mittee.
p.001275: (7) COMPENSATION.—Members of the Committee who are officers or employees of the United States shall serve
p.001275: without compensation. Members of the Committee who are not officers or employees of the United States shall
p.001275: receive compensation, for each day (including travel time) they are engaged in the performance of the
p.001275: functions of the Committee. Such com- pensation may not be in an amount in excess of the daily
p.001275: equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5, United
p.001275: States Code) for positions above GS–15.
p.001275: (d) CERTAIN REQUIREMENTS REGARDING DUTIES.—
p.001275: (1) RECOMMENDATIONS REGARDING LANGUAGE.—
...

p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001529:
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p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
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p.000545: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for the
p.000545: purpose of carrying out this section.
p.000545: SEC. 399S. ø280g–7¿ AMYOTROPHIC LATERAL SCLEROSIS REGISTRY.
p.000545: (a) ESTABLISHMENT.—
p.000545: (1) IN GENERAL.—Not later than 1 year after the receipt of the report described in subsection (b)(2)(A), the Secretary,
p.000545: act- ing through the Director of the Centers for Disease Control and Prevention, may, if scientifically
p.000545: advisable—
p.000545: (A) develop a system to collect data on amyotrophic lateral sclerosis (referred to in this section as
p.000545: ‘‘ALS’’) and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some
p.000545: cases progress to ALS, including information with respect to the incidence and prevalence of the disease in the
p.000545: United States; and
p.000545: (B) establish a national registry for the collection and storage of such data to develop a population-based
p.000545: registry of cases in the United States of ALS and other motor neu- ron disorders that can be confused with ALS,
p.000545: misdiagnosed as ALS, and in some cases progress to ALS.
p.000545: (2) PURPOSE.—It is the purpose of the registry established under paragraph (1)(B) to—
p.000545: (A) better describe the incidence and prevalence of ALS in the United States;
p.000545: (B) examine appropriate factors, such as environ- mental and occupational, that may be associated
p.000545: with the disease;
p.000545: (C) better outline key demographic factors (such as age, race or ethnicity, gender, and family history
p.000545: of indi- viduals who are diagnosed with the disease) associated with the disease;
p.000545: (D) better examine the connection between ALS and other motor neuron disorders that can be confused with
p.000545: ALS, misdiagnosed as ALS, and in some cases progress to ALS; and
p.000545: (E) other matters as recommended by the Advisory Committee established under subsection (b).
p.000545: (b) ADVISORY COMMITTEE.—
p.000545: (1) ESTABLISHMENT.—Not later than 180 days after the date of the enactment of this section, the
p.000545: Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a
p.000545: committee to be known as the Ad- visory Committee on the National ALS Registry (referred to in
p.000545: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000545:
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p.000547: PUBLIC HEALTH SERVICE ACT
p.000547: Sec. 399S
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p.000567: Sec. 399V–6 PUBLIC HEALTH SERVICE ACT 568
p.000567:
p.000567: (2) provides legislative recommendations or describes addi- tional resources required by the Centers of Excellence.
p.000567: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated such sums as may be necessary to
p.000567: carry out this section.
p.000567: (f) NO DUPLICATION OF EFFORT.—In carrying out activities of the Centers of Excellence or other programs
p.000567: under this section, the Secretary shall not duplicate other Federal foodborne illness re- sponse efforts.
p.000567: SEC. 399V–6. ø280g–17¿ DESIGNATION AND INVESTIGATION OF POTEN- TIAL CANCER CLUSTERS.
p.000567: (a) DEFINITIONS.—In this section:
p.000567: (1) CANCER CLUSTER.—The term ‘‘cancer cluster’’ means the incidence of a particular cancer within a population
p.000567: group, a geographical area, and a period of time that is greater than expected for such group, area, and
p.000567: period.
p.000567: (2) PARTICULAR CANCER.—The term ‘‘particular cancer’’ means one specific type of cancer or a type of cancers
p.000567: scientif- ically proven to have the same cause.
p.000567: (3) POPULATION GROUP.—The term ‘‘population group’’ means a group, for purposes of calculating cancer
p.000567: rates, de- fined by factors such as race, ethnicity, age, or gender.
p.000567: (b) CRITERIA FOR DESIGNATION OF POTENTIAL CANCER CLUS-
p.000567: TERS.—
p.000567: (1) DEVELOPMENT OF CRITERIA.—The Secretary shall de- velop criteria for the designation of potential
p.000567: cancer clusters.
p.000567: (2) REQUIREMENTS.—The criteria developed under para- graph (1) shall consider, as appropriate—
p.000567: (A) a standard for cancer cluster identification and re- porting protocols used to determine when cancer incidence is
p.000567: greater than would be typically observed;
p.000567: (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same
p.000567: type of cancer, or types of cancers;
p.000567: (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age,
p.000567: and gender, for purposes of calculating cancer rates;
p.000567: (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create
p.000567: or obscure a potential cluster by selection of a specific area; and
p.000567:
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p.000567: (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected num- ber
p.000567: of cases, occurs.
p.000567: (c) GUIDELINES FOR INVESTIGATION OF POTENTIAL CANCER CLUSTERS.—The Secretary, in consultation with
p.000567: the Council of State and Territorial Epidemiologists and representatives of State and local health
p.000567: departments, shall develop, publish, and periodi- cally update guidelines for investigating potential cancer
p.000567: clusters. The guidelines shall—
p.000567: (1) recommend that investigations of cancer clusters—
p.000567: (A) use the criteria developed under subsection (b);
p.000567: (B) use the best available science; and
p.000567: (C) rely on a weight of the scientific evidence;
p.000567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000569: PUBLIC HEALTH SERVICE ACT
p.000569: Sec. 399V–6
p.000569:
p.000569: (2) provide standardized methods of reviewing and catego- rizing data, including from health surveillance systems and
p.000569: re- ports of potential cancer clusters; and
...

p.000611: ance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (re-
p.000611: ferred to in this subsection as the ‘‘registry data bank’’). The Director of NIH shall ensure that the
p.000611: reg- istry data bank is made publicly available through the Internet.
p.000611: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000613: PUBLIC HEALTH SERVICE ACT
p.000613: Sec. 402
p.000613:
p.000613: (ii) CONTENT.—The clinical trial information re- quired to be submitted under this paragraph for an
p.000613: applicable clinical trial shall include—
p.000613: (I) descriptive information, including—
p.000613: (aa) a brief title, intended for the lay pub-
p.000613: lic;
p.000613: (bb) a brief summary, intended for the lay
p.000613: public;
p.000613: (cc) the primary purpose; (dd) the study design;
p.000613: (ee) for an applicable drug clinical trial, the study phase;
p.000613: (ff) study type;
p.000613: (gg) the primary disease or condition being studied, or the focus of the study;
p.000613: (hh) the intervention name and interven- tion type;
p.000613: (ii) the study start date;
p.000613: (jj) the expected completion date;
p.000613: (kk) the target number of subjects; and (ll) outcomes, including primary and sec-
p.000613: ondary outcome measures;
p.000613: (II) recruitment information, including— (aa) eligibility criteria;
p.000613: (bb) gender; (cc) age limits;
p.000613: (dd) whether the trial accepts healthy vol- unteers;
p.000613: (ee) overall recruitment status; (ff) individual site status; and
p.000613: (gg) in the case of an applicable drug clin- ical trial, if the drug is not approved under section 505 of
p.000613: the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not
p.000613: there is ex- panded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act
p.000613: for those who do not qualify for enrollment in the clinical trial and how to obtain informa- tion about such
p.000613: access;
p.000613: (III) location and contact information, includ- ing—
p.000613:
p.000613:
p.000613: and
p.000613: (aa) the name of the sponsor;
p.000613: (bb) the responsible party, by official title;
p.000613: (cc) the facility name and facility contact
p.000613:
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p.000613: January 30, 2020
p.000613: information (including the city, State, and zip code for each clinical trial location, or a toll- free number
p.000613: through which such location in- formation may be accessed); and
p.000613: (IV) administrative data (which the Secretary may make publicly available as necessary), includ- ing—
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p.000655: focused on promoting and providing opportunities for new researchers and earlier re- search independence.
p.000655: (b) ACTIVITIES.—The Director of the National Institutes of Health, through the Initiative shall—
p.000655: (1) promote policies and programs within the National In- stitutes of Health that are focused on improving
p.000655: opportunities for new researchers and promoting earlier research independ- ence, including existing policies and
p.000655: programs, as appropriate;
p.000655: (2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote
p.000655: opportunities for new researchers and earlier research independence, such as policies to increase opportunities
p.000655: for new researchers to receive funding, enhance training and mentorship programs for re- searchers, and enhance
p.000655: workforce diversity;
p.000655: (3) coordinate, as appropriate, with relevant agencies, pro- fessional and academic associations, academic
p.000655: institutions, and others, to improve and update existing information on the bio- medical research workforce in order to
p.000655: inform programs related to the training, recruitment, and retention of biomedical re- searchers; and
p.000655: (4) carry out other activities, including evaluation and oversight of existing programs, as appropriate,
p.000655: to promote the development of the next generation of researchers and earlier research independence.
p.000655: SEC. 404N. ø283p¿ POPULATION FOCUSED RESEARCH.
p.000655: The Director of the National Institutes of Health shall, as ap- propriate, encourage efforts to improve
p.000655: research related to the health of sexual and gender minority populations, including by—
p.000655: (1) facilitating increased participation of sexual and gender minority populations in clinical research supported by
p.000655: the Na- tional Institutes of Health, and reporting on such participation, as applicable;
p.000655: (2) facilitating the development of valid and reliable meth- ods for research relevant to sexual and gender
p.000655: minority popu- lations; and
p.000655: (3) addressing methodological challenges.
p.000655: PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000655: APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH INSTITUTES
p.000655:
p.000655:
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p.000655: January 30, 2020
p.000655: SEC. 405. ø284¿
p.000655: (a) APPOINTMENT.—
p.000655: (1) IN GENERAL.—The Director of the National Cancer In- stitute shall be appointed by the President, and
p.000655: the Directors of the other national research institutes and national centers shall be appointed by the
p.000655: Secretary, acting through the Direc- tor of National Institutes of Health. Each Director of a national research
p.000655: institute or national center shall report directly to the Director of National Institutes of Health.
p.000655: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000657: PUBLIC HEALTH SERVICE ACT
p.000657: Sec. 405
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p.000787: data has been determined to be an appropriate func- tion; and
p.000787: (E) encouraging the national research institutes to conduct and support such research, including such clinical
p.000787: trials.
p.000787: (d) ADVISORY COMMITTEE.—
p.000787: (1) In carrying out subsection (b), the Director of the Office shall establish an advisory committee to be known as the
p.000787: Advi- sory Committee on Research on Women’s Health (in this sub- section referred to as the ‘‘Advisory
p.000787: Committee’’).
p.000787: (2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not
p.000787: officers or employees of the Federal Government. The Director of NIH shall make appointments to the Advisory
p.000787: Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical
p.000787: practice, research specialization, or professional expertise includes a significant focus on re- search on
p.000787: women’s health. A majority of the members of the Advisory Committee shall be women.
p.000787: (3) The Director of the Office shall serve as the chair of the Advisory Committee.
p.000787: (4) The Advisory Committee shall—
p.000787: (A) advise the Director of the Office on appropriate re- search activities to be undertaken by the national research
p.000787: institutes with respect to—
p.000787: (i) research on women’s health;
p.000787: (ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
p.000787: (iii) research on gender differences in disease eti- ology, course, and treatment;
p.000787: (iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and
p.000787: (v) research on women’s health conditions which require a multidisciplinary approach;
p.000787: (B) report to the Director of the Office on such re- search;
p.000787: (C) provide recommendations to such Director regard- ing activities of the Office (including
p.000787: recommendations on the development of the methodologies described in sub- section (c)(4)(C) and recommendations
p.000787: on priorities in car- rying out research described in subparagraph (A)); and
p.000787: (D) assist in monitoring compliance with section 492B regarding the inclusion of women in clinical research. (5)(A) The
p.000787: Advisory Committee shall prepare a biennial re-
p.000787: port describing the activities of the Committee, including find- ings made by the Committee regarding—
p.000787: (i) compliance with section 492B;
p.000787: (ii) the extent of expenditures made for research on women’s health by the agencies of the National
p.000787: Institutes of Health; and
p.000787: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000857:
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p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.001133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001133:
p.001135: 1135
p.001135: PUBLIC HEALTH SERVICE ACT
p.001135: Sec. 926
p.001135:
p.001135: data described in paragraph (1), such protections shall con- tinue to apply to such work product or data after
p.001135: the entity is removed from the listing under subsection (e)(3)(A).
p.001135: (g) DISPOSITION OF WORK PRODUCT AND DATA.—If the Sec- retary removes a patient safety organization
p.001135: from the listing as provided for in subsection (e)(3)(A), with respect to the patient safe- ty work product or
p.001135: data described in subsection (f)(1) that the pa- tient safety organization received from another entity, such
p.001135: former patient safety organization shall—
p.001135: (1) with the approval of the other entity and a patient safety organization, transfer such work product or
p.001135: data to such patient safety organization;
p.001135: (2) return such work product or data to the entity that submitted the work product or data; or
p.001135: (3) if returning such work product or data to such entity is not practicable, destroy such work product or
p.001135: data.
p.001135: SEC. 925. ø299b–24a¿ ACTIVITIES REGARDING WOMEN’S HEALTH.
p.001135: (a) ESTABLISHMENT.—There is established within the Office of the Director, an Office of Women’s Health
p.001135: and Gender-Based Re- search (referred to in this section as the ‘‘Office’’). The Office shall be headed by a
p.001135: director who shall be appointed by the Director of Healthcare and Research Quality.
p.001135: (b) PURPOSE.—The official designated under subsection (a) shall—
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135:
p.001135: January 30, 2020
p.001135: (1) report to the Director on the current Agency level of ac- tivity regarding women’s health, across, where
p.001135: appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the
p.001135: development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes,
p.001135: delivery of health care services, quality of care, and access to health care;
p.001135: (2) establish short-range and long-range goals and objec- tives within the Agency for research important
p.001135: to women’s health and, as relevant and appropriate, coordinate with other appropriate offices on activities within
p.001135: the Agency that relate to health services and medical effectiveness research, for issues of particular concern to
p.001135: women;
...

p.001665: tient, including due to age-related and other disability, cognitive impairment, or dementia.
p.001665: (iv) Subject to subparagraph (D), any other target area that the HIT Advisory Committee identifies as an appropriate
p.001665: target area to be considered under this subparagraph.
p.001665: (C) ADDITIONAL TARGET AREAS.—For purposes of this section, the HIT Advisory Committee may make rec-
p.001665: ommendations under subparagraph (A), in addition to areas described in subparagraph (B), with respect
p.001665: to any of the following areas:
p.001665: (i) The use of health information technology to im- prove the quality of health care, such as by promoting the
p.001665: coordination of health care and improving con- tinuity of health care among health care providers, re- ducing
p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001665:
p.001665:
p.001665:
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p.001665:
p.001665: Sec. 3002 PUBLIC HEALTH SERVICE ACT 1666
p.001665:
p.001665:
...

Searching for indicator child protective services:

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p.000497:
p.000497:
p.000497:
p.000497:
p.000497:
p.000497:
p.000497: January 30, 2020
p.000497: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000497: (h) SUBMISSION TO SECRETARY OF CERTAIN INFORMATION.—The Secretary may make a grant under subsection (a) only if
p.000497: the appli- cant involved submits to the Secretary—
p.000497: (1) a description of the population that is to receive serv- ices under this section and a description
p.000497: of such services that are to be provided and measurable goals and objectives;
p.000497: (2) a description of the mechanism that will be used to in- volve the local public agencies responsible for
p.000497: health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse
p.000497: treatment programs in plan- ning and providing services under this section, as well as evi- dence that
p.000497: the proposal has been coordinated with the State agencies responsible for administering those programs and the
p.000497: State agency responsible for administering public maternal and child health services;
p.000497: (3) information demonstrating that the applicant has es- tablished a collaborative relationship with child
p.000497: welfare agen- cies and child protective services that will enable the applicant, where appropriate, to—
p.000497: (A) provide advocacy on behalf of substance abusers and the children of substance abusers in child
p.000497: protective services cases;
p.000497: (B) provide services to help prevent the unnecessary placement of children in substitute care; and
p.000497: (C) promote reunification of families or permanent plans for the placement of the child; and
p.000497: (4) such other information as the Secretary determines to be appropriate.
p.000497: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant involved
p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
p.000497: accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000497:
p.000497:
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...

Searching for indicator orphan:

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p.000001: 314(c), 314(d), and 314(e) of this Act in situations in which grants are sought or made under two or more of
p.000001: such pro- grams with respect to a single project, the Secretary is authorized to promulgate regulations—
p.000001: (1) under which the administrative functions under such programs with respect to such project will be
p.000001: performed by a single administrative unit which is the administrative unit charged with the administration of
p.000001: any of such programs or is the administrative unit charged with the supervision of two or more of such programs;
p.000001: (2) designed to reduce the number of applications, reports, and other materials required under such programs to
p.000001: be sub- mitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the extent
p.000001: feasible), the data and information required to be contained in such applications, reports, and other materials; and
p.000001: (3) under which inconsistent or duplicative requirements imposed by such programs will be revised and
p.000001: made uniform with respect to such project;
p.000001: except that nothing in this section shall be construed to authorize the Secretary to waive or suspend, with
p.000001: respect to any such project, any requirement with respect to any of such programs if such re- quirement is
p.000001: imposed by law or by any regulation required by law.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: ORPHAN PRODUCTS BOARD
p.000001: SEC. 227. ø236¿ (a) There is established in the Department of Health and Human Services a board for the
p.000001: development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or
p.000001: conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for
p.000001: Health of the Department of Health and Human Services and rep- resentatives, selected by the Secretary, of the
p.000001: Food and Drug Ad- ministration, the National Institutes of Health, the Centers for Dis- ease Control and Prevention,
p.000001: and any other Federal department or agency which the Secretary determines has activities relating to drugs and
p.000001: devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board.
p.000001: (b) The function of the Board shall be to promote the develop- ment of drugs and devices for rare diseases or
p.000001: conditions and the coordination among Federal, other public, and private agencies in carrying out their
p.000001: respective functions relating to the development of such articles, such diseases or conditions.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001: C:\XML\PHSA.BEL HOUSEP
p.000001:
p.000001:
p.000001: C:\XML\SSA-MERGED.XML
p.000001:
p.000001: Sec. 227 PUBLIC HEALTH SERVICE ACT 46
p.000001:
p.000001: (c) In the case of drugs for rare diseases or conditions the Board shall—
p.000001: (1) evaluate—
p.000001: (A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act on the development of such drugs,
p.000001: and
p.000001: (B) the implementation of such subchapter; 15
...

p.000001: report a report on the rare disease and condition research activities of the Institutes of the Na- tional
p.000001: Institutes of Health; the Secretary of the Treasury shall sub-
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 15 So in law. The semicolon probably should be a comma.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001: 47 PUBLIC HEALTH SERVICE ACT Sec. 228
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: mit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by
p.000001: section 44H of the Inter- nal Revenue Code of 1954; and the Secretary of Health and Human Services shall submit
p.000001: to the Board for inclusion in the annual re- port a report on the program of assistance under section
p.000001: 5 of the Orphan Drug Act for the development of drugs for rare diseases and conditions. Each annual
p.000001: report shall be submitted by June 1 of each year for the preceding calendar year.
p.000001: SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE
p.000001: SEC. 228. ø237¿ (a)(1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical
p.000001: Research and Bio- medical Product Assessment Service (in this section referred to as the ‘‘Service’’), not
p.000001: to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified
p.000001: scientific and technical experts in the fields of biomedical research, clinical re- search evaluation, and
p.000001: biomedical product assessment.
p.000001: (2) The authority established in paragraph (1) may not be con- strued to require the Secretary to reduce the number of
p.000001: employees serving under any other employment system in order to offset the number of members serving in the
p.000001: Service.
p.000001: (3) The Secretary shall assign experts under this section to agencies within the Department of Health
p.000001: and Human Services taking into account the need for the expertise of such expert.
p.000001: (b) The Service shall be appointed by the Secretary without re- gard to the provisions of title 5, United States Code,
p.000001: regarding ap- pointment, and shall consist of individuals outstanding in the field of biomedical research, clinical
p.000001: research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such
...

p.000349: (ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in
p.000349: providing good nutrition (by the purchasing and prepara- tion of food).
p.000349: (3) In making grants and entering into contracts under this subsection, special consideration shall be given
p.000349: to entities which es- tablish or will establish programs to provide training for persons fifty years of age
p.000349: and older who wish to become paraprofessionals (including homemaker home health aides) to provide home
p.000349: health services.
p.000349: (4) Applications for grants and contracts under this subsection shall be in such form and contain such
p.000349: information as the Sec- retary shall prescribe.
p.000349: (5) There are authorized to be appropriated for grants and con- tracts under this subsection $2,000,000 for each of the
p.000349: fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and
p.000349: September 30, 1987.
p.000349: (c) The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee
p.000349: on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
p.000349: (1) the impact of grants made and contracts entered into under subsections (a) and (b) (as such
p.000349: subsections were in ef- fect prior to October 1, 1981);
p.000349: (2) the need to continue grants and loans under sub- sections (a) and (b) (as such subsections are in
p.000349: effect on the day after the date of enactment of the Orphan Drug Act); and
p.000349: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000349:
p.000349:
p.000349:
p.000349:
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p.000349:
p.000349:
p.000351: 351
p.000351: PUBLIC HEALTH SERVICE ACT
p.000351: Sec. 340
p.000351:
p.000351: (3) the extent to which standards have been applied to the training of personnel who provide home health services.
p.000351: (d) For purposes of this section, the term ‘‘home health serv- ices’’ has the meaning prescribed for
p.000351: the term by section 1861(m) of the Social Security Act.
p.000351: Subpart V—Healthy Communities Access Program
p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
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p.000351:
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p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
p.000351:
p.000351: January 30, 2020
p.000351: SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFI- CIENCY, AND COORDINATION OF SERVICES FOR THE
p.000351: UN- INSURED AND UNDERINSURED.
p.000351: (a) IN GENERAL.—The Secretary may award grants to eligible entities to assist in the development of integrated
...

p.000367: entity where, in the judgment of such official or body, con- solidation is appropriate and consistent with the
p.000367: goals of fairness and economy of resources; and
p.000367: (vi) include provisions and procedures to permit multiple covered entities to jointly assert claims of
p.000367: overcharges by the same manufacturer for the same drug or drugs in one administrative proceeding, and
p.000367: permit such claims to be asserted on behalf of covered entities by associations or organizations representing
p.000367: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000367:
p.000367:
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p.000367:
p.000367: Sec. 340C PUBLIC HEALTH SERVICE ACT 368
p.000367:
p.000367: the interests of such covered entities and of which the covered entities are members.
p.000367: (C) FINALITY OF ADMINISTRATIVE RESOLUTION.—The administrative resolution of a claim or claims under
p.000367: the regulations promulgated under subparagraph (A) shall be a final agency decision and shall be binding upon the
p.000367: par- ties involved, unless invalidated by an order of a court of competent jurisdiction.
p.000367: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000367: sums as may be necessary for fiscal year 2010 and each succeeding fiscal year.
p.000367: (e) 51 EXCLUSION OF ORPHAN DRUGS FOR CERTAIN COVERED EN- TITIES.—For covered entities described in
p.000367: subparagraph (M) (other than a children’s hospital described in subparagraph (M)), (N), or
p.000367: (O) of subsection (a)(4), the term ‘‘covered outpatient drug’’ shall not include a drug designated by
p.000367: the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or
p.000367: condition.
p.000367: Subpart VIII—Bulk Purchases of Vaccines for Certain Programs
p.000367: BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS
p.000367: SEC. 340C. ø256c¿ (a) AGREEMENTS FOR PURCHASES.—
p.000367: (1) IN GENERAL.—Not later than 180 days after the date of the enactment of the Preventive Health Amendments
p.000367: of 1992 52, the Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention and
p.000367: in consultation with the Administrator of the Health Resources and Services Administration, shall enter into
p.000367: negotiations with manufactur- ers of vaccines for the purpose of establishing and maintaining agreements under which
p.000367: entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in
p.000367: the agreements.
p.000367: (2) RELEVANT ENTITIES.—The entities referred to in para- graph (1) are entities that provide immunizations
p.000367: against vac- cine-preventable diseases with assistance provided under sec- tion 330.
p.000367: (b) NEGOTIATION OF PRICES.—In carrying out subsection (a), the Secretary shall, to the extent practicable,
...

p.000781: this section referred to as the ‘‘Director’’), appointed by the Director of the Center.
p.000781: (b) DUTIES.—
p.000781: (1) IN GENERAL.—The Director of the Office shall carry out the following:
p.000781: (A) The Director shall recommend an agenda for con- ducting and supporting research on rare diseases
p.000781: through the national research institutes and centers. The agenda shall provide for a broad range of
p.000781: research and education activities, including scientific workshops and symposia to identify research
p.000781: opportunities for rare diseases.
p.000781: (B) The Director shall, with respect to rare diseases, promote coordination and cooperation among the
p.000781: national research institutes and centers and entities whose re- search is supported by such institutes.
p.000781: (C) The Director, in collaboration with the directors of the other relevant institutes and centers of the
p.000781: National Institutes of Health, may enter into cooperative agree- ments with and make grants for regional centers
p.000781: of excel- lence on rare diseases in accordance with section 481A.
p.000781: (D) The Director shall promote the sufficient allocation of the resources of the National Institutes of Health
p.000781: for conducting and supporting research on rare diseases.
p.000781: (E) The Director shall promote and encourage the es- tablishment of a centralized clearinghouse for rare and
p.000781: ge- netic disease information that will provide understandable information about these diseases to the public,
p.000781: medical professionals, patients and families.
p.000781: (2) PRINCIPAL ADVISOR REGARDING ORPHAN DISEASES.— With respect to rare diseases, the Director
p.000781: shall serve as the principal advisor to the Director of NIH and shall provide ad- vice to other relevant
p.000781: agencies. The Director shall provide liai- son with national and international patient, health and sci- entific
p.000781: organizations concerned with rare diseases.
p.000781: (c) DEFINITION.—For purposes of this section, the term ‘‘rare disease’’ means any disease or condition
p.000781: that affects less than 200,000 persons in the United States.
p.000781:
p.000781:
p.000781:
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p.000781:
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p.000781:
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p.000781:
p.000781:
p.000781:
p.000781: January 30, 2020
p.000781: RARE DISEASE REGIONAL CENTERS OF EXCELLENCE
p.000781: SEC. 481A. ø287a–2¿ (a) COOPERATIVE AGREEMENTS AND
p.000781: GRANTS.—
p.000781: (1) IN GENERAL.—The Director of the Office of Rare Dis- eases (in this section referred to as the
p.000781: ‘‘Director’’), in collabo- ration with the directors of the other relevant institutes and centers of the
p.000781: National Institutes of Health, may enter into co- operative agreements with and make grants to public or pri-
p.000781: vate nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing
p.000781: basic operating support for regional centers of excellence for clinical research
p.000781: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000781:
p.000781:
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Searching for indicator parent:

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p.000017:
p.000017: 65 PUBLIC HEALTH SERVICE ACT Sec. 266
p.000017:
p.000017: (A) IN GENERAL.—Except as provided in subparagraph (B), an eligible individual shall not be provided compensa- tion
p.000017: under this section for the first 5 work days of loss of employment income.
p.000017: (B) EXCEPTION.—Subparagraph (A) does not apply if the period of loss of employment income of an eligible indi-
p.000017: vidual is 10 or more work days.
p.000017: (5) TERMINATION OF BENEFITS.—No payment shall be made under subsection (a) in compensation for loss of
p.000017: employment income once the eligible individual involves reaches the age of 65.
p.000017: (d) BENEFIT IN ADDITION TO MEDICAL BENEFITS.—A benefit under subsection (a) shall be in addition to
p.000017: any amounts received by an eligible individual under section 264.
p.000017: SEC. 266. ø239e¿ PAYMENT FOR DEATH.
p.000017: (a) DEATH BENEFIT.—
p.000017: (1) IN GENERAL.—The Secretary shall pay, in the case of an eligible individual whose death is determined to have
p.000017: resulted from a covered injury or injuries, a death benefit in the amount determined under
p.000017: paragraph (2) to the survivor or sur- vivors in the same manner as death benefits are paid pursuant to the Public
p.000017: Safety Officers’ Benefits Program under subpart 1 of part L of title I of the Omnibus Crime Control
p.000017: and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) with respect to an eligible deceased (except that in the
p.000017: case of an eligible indi- vidual who is a minor with no living parent, the legal guardian shall be considered the
p.000017: survivor in the place of the parent).
p.000017: (2) BENEFIT AMOUNT.—
p.000017: (A) IN GENERAL.—The amount of the death benefit under paragraph (1) in a fiscal year shall equal
p.000017: the amount of the comparable benefit calculated under the Public Safety Officers’ Benefits Program under
p.000017: subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et
p.000017: seq.) in such fiscal year, without regard to any reduction attributable to a lim- itation on appropriations, but
p.000017: subject to subparagraph (B).
p.000017: (B) REDUCTION FOR PAYMENTS FOR LOST EMPLOYMENT INCOME.—The amount of the benefit as determined under
p.000017: subparagraph (A) shall be reduced by the total amount of any benefits paid under section 265 with
p.000017: respect to lost employment income.
p.000017: (3) LIMITATIONS.—
p.000017: (A) IN GENERAL.—No benefit is payable under para- graph (1) with respect to the death of an eligible individual
p.000017: if—
p.000017:
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p.000017: (i) a disability benefit is paid with respect to such individual under the Public Safety Officers’ Benefits
p.000017: Program under subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of
p.000017: 1968 (42 U.S.C. 3796 et seq.); or
p.000017: (ii) a death benefit is paid or payable with respect to such individual under the Public Safety Officers’
p.000017: Benefits Program under subpart 1 of part L of title I
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
p.000017:
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p.000283: in providing adoption in- formation and referrals to pregnant women on an equal basis with all other
p.000283: courses of action included in nondirective coun- seling to pregnant women.
p.000283: (2) BEST-PRACTICES GUIDELINES.—
p.000283: (A) IN GENERAL.—A condition for the receipt of a grant under paragraph (1) is that the adoption organization
p.000283: in- volved agree that, in providing training under such para- graph, the organization will follow the
p.000283: guidelines devel- oped under subparagraph (B).
p.000283: (B) PROCESS FOR DEVELOPMENT OF GUIDELINES.—
p.000283: (i) IN GENERAL.—The Secretary shall establish and supervise a process described in clause (ii) in
p.000283: which the participants are—
p.000283: (I) an appropriate number and variety of adoption organizations that, as a group, have ex- pertise
p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
p.000285: (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing
...

p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000495: (E) Remedial education services.
p.000495: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000495: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000495: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000495: lives of substance abusers or the chil- dren of substance abusers:
p.000495: (A) An assessment of the strengths and service needs of the family and the assignment of a case
p.000495: manager who will coordinate services for the family.
p.000495: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and
p.000495: chil- dren, and family therapy.
p.000495: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000495: respite care services.
p.000495: (D) Parenting education services and parent support groups.
p.000495: (E) Support services, including, where appropriate, transportation services.
p.000495: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000495: (G) Aftercare services, including continued support through parent groups and home visits.
p.000495: (d) CONSIDERATIONS IN MAKING GRANTS.—In making grants under subsection (a), the Secretary shall ensure that
p.000495: the grants are reasonably distributed among the following types of entities:
p.000495: (1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and
p.000495: their children.
p.000495: (2) Public or nonprofit private entities that provide health or social services to disadvantaged populations,
p.000495: and that have—
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p.000495: (A) expertise in applying the services to the particular problems of substance abusers and the children of sub-
p.000495: stance abusers; and
p.000495: (B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
p.000495: (3) Consortia of public or nonprofit private entities that in- clude at least one substance abuse treatment program.
p.000495: (4) Indian tribes.
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p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: Sec. 399A PUBLIC HEALTH SERVICE ACT 500
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p.000499:
p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
p.000499: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000499: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000499: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
...

p.000503: (D) Where appropriate, counseling regarding family vi- olence.
p.000503: (E) Career planning and education services.
p.000503: (F) Referrals for, and assistance in establishing eligi- bility for, services described in subsection (b)(7).
p.000503: (3) In the case of substance abusers, spouses of substance abusers, extended family members of substance
p.000503: abusers, care- takers of children of substance abusers, and other people sig- nificantly involved in the
p.000503: lives of substance abusers or the chil- dren of substance abusers:
p.000503: (A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will
p.000503: coordinate services for the family.
p.000503: (B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families
p.000503: and chil- dren, and family therapy.
p.000503: (C) Child care or other care for the child to enable the parent to attend treatment or other activities and
p.000503: respite care services.
p.000503: (D) Parenting education services and parent support groups which include child abuse and neglect
p.000503: prevention techniques.
p.000503: (E) Support services, including, where appropriate, transportation services.
p.000503: (F) Where appropriate, referral of other family mem- bers to related services such as job training.
p.000503: (G) Aftercare services, including continued support through parent groups and home visits.
p.000503: (d) TRAINING FOR PROVIDERS OF SERVICES TO CHILDREN AND
p.000503: FAMILIES.—The Secretary may make a grant under subsection (a)
p.000503: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000503:
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p.000503: Sec. 399A PUBLIC HEALTH SERVICE ACT 504
p.000503:
p.000503: for the training of health, substance abuse and mental health pro- fessionals and other providers of
p.000503: services to children and families through youth service agencies, family social services, child care
p.000503: providers, Head Start, schools and after-school programs, early childhood development programs, community-based
p.000503: family resource centers, the criminal justice system, and other providers of services to children and
...

p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
p.000507: (4) The term ‘‘public or nonprofit private entities that pro- vide health or social services to disadvantaged
p.000507: populations’’ in- cludes community-based organizations, local public health de- partments, community action
p.000507: agencies, hospitals, community health centers, child welfare agencies, developmental disabil- ities service
...

p.000104: October 30, 2004. Section 3(b) of such Public Law provides as follows: ‘‘The amend- ments made by this section
p.000104: shall apply only with respect to grants made on or after the date that is 9 months after the date of the
p.000104: enactment of this Act.’’.
p.000104: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000527: PUBLIC HEALTH SERVICE ACT
p.000527: Sec. 399L
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p.000527: (iii) the health care practitioner formulates a writ- ten treatment plan for managing asthma or anaphy- laxis
p.000527: episodes of the student and for medication use by the student during school hours; and
p.000527: (iv) the student’s parent or guardian has com- pleted and submitted to the school any written docu-
p.000527: mentation required by the school, including the treat- ment plan formulated under clause (iii) and other doc-
p.000527: uments related to liability.
p.000527: (B) SCOPE.—An authorization granted under subpara- graph (A) must allow the student involved to possess
p.000527: and use his or her medication—
p.000527: (i) while in school;
p.000527: (ii) while at a school-sponsored activity, such as a sporting event; and
p.000527: (iii) in transit to or from school or school-spon- sored activities.
p.000527: (C) DURATION OF AUTHORIZATION.—An authorization granted under subparagraph (A)—
p.000527: (i) must be effective only for the same school and school year for which it is granted; and
p.000527: (ii) must be renewed by the parent or guardian each subsequent school year in accordance with this
p.000527: subsection.
p.000527: (D) BACKUP MEDICATION.—The State must require that backup medication, if provided by a student’s
p.000527: parent or guardian, be kept at a student’s school in a location to which the student has immediate access in
p.000527: the event of an asthma or anaphylaxis emergency.
p.000527: (E) MAINTENANCE OF INFORMATION.—The State must require that information described in subparagraphs
p.000527: (A)(iii) and (A)(iv) be kept on file at the student’s school in a location easily accessible in the event of an
p.000527: asthma or anaphylaxis emergency.
p.000527: (F) SCHOOL PERSONNEL ADMINISTRATION OF EPINEPH- RINE.—In determining the preference (if any) to be
p.000527: given to a State under this subsection, the Secretary shall give additional preference to a State that
p.000527: provides to the Sec- retary the certification described in subparagraph (G) and that requires that each public
p.000527: elementary school and sec- ondary school in the State—
p.000527: (i) permits trained personnel of the school to ad- minister epinephrine to any student of the school rea-
p.000527: sonably believed to be having an anaphylactic reac- tion;
p.000527: (ii) maintains a supply of epinephrine in a secure location that is easily accessible to trained personnel of
p.000527: the school for the purpose of administration to any student of the school reasonably believed to be having an
p.000527: anaphylactic reaction; and
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p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000531:
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p.000531: Sec. 399M PUBLIC HEALTH SERVICE ACT 532
p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
p.000531: (v) referral to national and local consumer, self- help, parent, family, and education organizations, and other
p.000531: family-centered services.
p.000531: (2) The term ‘‘early intervention’’means—
p.000531: (A) providing appropriate services for the child who is deaf or hard-of-hearing, including nonmedical services; and
p.000531: (B) ensuring that the family of the child is—
p.000531: (i) provided comprehensive, consumer-oriented in- formation about the full range of family support, train- ing,
p.000531: information services, and language acquisition in oral and visual modalities; and
p.000531: (ii) given the opportunity to consider and obtain the full range of such appropriate services, educational and
p.000531: program placements, and other options for the child from highly qualified providers.
p.000531: (3) 105 The term ‘‘medical evaluation’’ means key compo- nents performed by a physician including history,
p.000531: examination, and medical decisionmaking focused on symptomatic and re- lated body systems for the purpose
p.000531: of diagnosing the etiology of hearing loss and related physical conditions, and for identi- fying
p.000531: appropriate treatment and referral options.
p.000531: (4) The term ‘‘medical intervention’’means the process by which a physician provides medical diagnosis and
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p.000575: period shall be eligible for a grant under this section for with re- spect to the same grant period.
p.000575: (g) MATCHING REQUIREMENT.—
p.000575: (1) IN GENERAL.—Each eligible entity that receives a grant under this section shall provide, from non-Federal
p.000575: sources, an amount equal to 20 percent of the amount of the grant (which may be provided in cash or in-kind) to carry
p.000575: out the activities supported by the grant.
p.000575: (2) WAIVER.—The Secretary may waive all or part of the matching requirement described in paragraph (1) for any
p.000575: fiscal year for the SBHC if the Secretary determines that applying the matching requirement to the SBHC would
p.000575: result in serious hardship or an inability to carry out the purposes of this sec- tion.
p.000575: (h) SUPPLEMENT, NOT SUPPLANT.—Grant funds provided under this section shall be used to supplement, not
p.000575: supplant, other Fed- eral or State funds.
p.000575: (i) EVALUATION.—The Secretary shall develop and implement a plan for evaluating SBHCs and monitoring quality
p.000575: performance under the awards made under this section.
p.000575: (j) AGE APPROPRIATE SERVICES.—An eligible entity receiving funds under this section shall only provide age
p.000575: appropriate services through a SBHC funded under this section to an individual.
p.000575: (k) PARENTAL CONSENT.—An eligible entity receiving funds under this section shall not provide services through a
p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000575:
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p.000587: (v) aggression, self-injury, elopement, and other behavioral issues;
p.000587: (vi) emergency room visits and acute care hos- pitalization;
p.000587: (vii) treatment for co-occurring physical and men- tal health conditions;
p.000587: (viii) premature mortality;
p.000587: (ix) medical practitioner training; and
p.000587: (x) caregiver mental health.
p.000587: SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000587: (a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RE- SEARCH PROGRAM.—To carry out section 399AA, there is
p.000587: authorized to be appropriated $23,100,000 for each of fiscal years 2020 through 2024.
p.000587: (b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVEN- TION.—To carry out section 399BB, there is authorized
p.000587: to be appro- priated $50,599,000 for each of fiscal years 2020 through 2024.
p.000587: (c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN OTHER PROGRAMS.—To carry out sections 399CC and
p.000587: 409C, there are authorized to be appropriated $296,000,000 for each of fiscal years 2020 through 2024.
p.000587: PART S—HEALTH CARE QUALITY PROGRAMS
p.000587: Subpart I—National Strategy for Quality Improvement in Health Care
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p.000587: January 30, 2020
p.000587: SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
p.000587: (a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
p.000587: (1) NATIONAL STRATEGY.—The Secretary, through a trans- parent collaborative process, shall establish a national
p.000587: strategy to improve the delivery of health care services, patient health outcomes, and population health.
p.000587: (2) IDENTIFICATION OF PRIORITIES.—
p.000587: (A) IN GENERAL.—The Secretary shall identify national priorities for improvement in developing the strategy
p.000587: under paragraph (1).
p.000587: (B) REQUIREMENTS.—The Secretary shall ensure that priorities identified under subparagraph (A) will—
p.000587: (i) have the greatest potential for improving the health outcomes, efficiency, and patient-centeredness of
p.000587: health care for all populations, including children and vulnerable populations;
p.000587: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000587: Sec. 399HH PUBLIC HEALTH SERVICE ACT 588
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p.000709: involve health functions or responsibil- ities relevant to such diseases, as determined by the Secretary.
p.000709: Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee
p.000709: shall meet at the call of the chairman, but not less often than four times a year.
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p.000709: January 30, 2020
p.000709: ADVISORY BOARDS
p.000709: SEC. 430. ø285c–4¿ (a) The Secretary shall establish in the In- stitute the National Diabetes Advisory Board, the
p.000709: National Diges- tive Diseases Advisory Board, and the National Kidney and Uro- logic Diseases Advisory Board
p.000709: (hereafter in this section individually referred to as an ‘‘Advisory Board’’).
p.000709: (b) Each Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000709: follows:
p.000709: (1) The Secretary shall appoint—
p.000709: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000709: not officers or employees of the United States, and who represent the specialties and disciplines
p.000709: relevant to the diseases with respect to which the Advisory Board is es- tablished; and
p.000709: (B) six members from the general public who are knowledgeable with respect to such diseases, including
p.000709: at least one member who is a person who has such a disease and one member who is a parent of a person who has such a
p.000709: disease.
p.000709: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in the fields of
p.000709: health edu-
p.000709: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000709: Sec. 430 PUBLIC HEALTH SERVICE ACT 710
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p.000709: January 30, 2020
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p.000709: cation, nursing, data systems, public information, and commu- nity program development.
p.000709: (2)(A) The following shall be ex officio members of each Ad- visory Board:
p.000709: (i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and
p.000709: Digestive and Kidney Diseases, the Director of the Centers for Disease Control and Prevention, the Chief Medical Di-
p.000709: rector of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, and the
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p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
p.000719:
p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
p.000719: members who are parents of children with arthritis.
p.000719: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in health
p.000719: education, nurs- ing, data systems, public information, or community program development.
p.000719: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000721: PUBLIC HEALTH SERVICE ACT
p.000721: Sec. 442
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p.000721: (2) The following shall be ex officio members of the Advi- sory Board:
p.000721: (A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and
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p.000743: January 30, 2020
p.000743: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS ADVISORY BOARD
p.000743: SEC. 464D. ø285m–4¿ (a) The Secretary shall establish in the Institute the National Deafness and Other
p.000743: Communications Dis- orders Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000743: (b) The Advisory Board shall be composed of eighteen ap- pointed members and nonvoting ex officio members as
p.000743: follows:
p.000743: (1) The Secretary shall appoint—
p.000743: (A) twelve members from individuals who are sci- entists, physicians, and other health and rehabilitation
p.000743: professionals, who are not officers or employees of the United States, and who represent the specialties
p.000743: and dis- ciplines relevant to deafness and other communication dis- orders, including not less than two persons with a
p.000743: commu- nication disorder; and
p.000743: (B) six members from the general public who are knowledgeable with respect to such disorders, including
p.000743: not less than one person with a communication disorder and not less than one person who is a parent
p.000743: of an indi- vidual with such a disorder.
p.000743: Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in
p.000743: diagnoses and re- habilitation of communication disorders, education of the hear- ing, speech, or language
p.000743: impaired, public health, public infor- mation, community program development, occupational haz- ards to
p.000743: communications senses, or the aging process.
p.000743: (2) The following shall be ex officio members of each Advi- sory Board:
p.000743: (A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness
p.000743: and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the
p.000743: Chief Medical Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for
p.000743: Health Affairs (or the designees of such officers).
p.000743: (B) Such other officers and employees of the United States as the Secretary determines necessary for the Advi-
p.000743: sory Board to carry out its functions.
p.000743: (c) Members of an Advisory Board who are officers or employ- ees of the Federal Government shall serve as
p.000743: members of the Advi- sory Board without compensation in addition to that received in their regular public
p.000743: employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the
p.000743: annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are
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p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
p.000881:
p.000881: that child-serving professionals and providers involved in early intervention and prevention services are properly
p.000881: trained in ef- fectively identifying youth who are at risk for suicide;
p.000881: (11) provide continuous training activities for child care professionals and community care providers on the
p.000881: latest youth suicide early intervention and prevention services practices and strategies;
p.000881: (12) conduct annual self-evaluations of outcomes and ac- tivities, including consulting with interested families
p.000881: and advo- cacy organizations;
p.000881: (13) provide services in areas or regions with rates of youth suicide that exceed the national average
p.000881: as determined by the Centers for Disease Control and Prevention; and
p.000881: (14) obtain informed written consent from a parent or legal guardian of an at-risk child before involving the
p.000881: child in a youth suicide early intervention and prevention program.
p.000881: (d) REQUIREMENT FOR DIRECT SERVICES.—Not less than 85 per- cent of grant funds received under this section shall be
p.000881: used to pro- vide direct services, of which not less than 5 percent shall be used for activities authorized under
p.000881: subsection (a)(3).
p.000881: (e) COORDINATION AND COLLABORATION.—
p.000881: (1) IN GENERAL.—In carrying out this section, the Sec- retary shall collaborate with relevant Federal agencies
p.000881: and sui- cide working groups responsible for early intervention and pre- vention services relating to youth suicide.
p.000881: (2) CONSULTATION.—In carrying out this section, the Sec- retary shall consult with—
p.000881: (A) State and local agencies, including agencies re- sponsible for early intervention and prevention
p.000881: services under title XIX of the Social Security Act, the State Chil- dren’s Health Insurance Program
p.000881: under title XXI of the Social Security Act, and programs funded by grants under title V of the Social Security Act;
p.000881: (B) local and national organizations that serve youth at risk for suicide and their families;
p.000881: (C) relevant national medical and other health and education specialty organizations;
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p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
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p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000989: (ii) such institution shall be assessed a risk-based premium in an amount equal to 10 percent of the prin- cipal amount
p.000989: of the loan.
p.000989: (B) DEFAULT MANAGEMENT PLAN.—An institution of the type described in subparagraph (A) shall prepare
p.000989: and submit to the Secretary for approval a plan that meets the requirements of paragraph (2)(B).
p.000989: (4) INELIGIBILITY.—An individual shall not be eligible to obtain a loan under this subpart for attendance
p.000989: at an institu- tion that has a default rate in excess of 20 percent.
p.000989: (c) REDUCTION OF RISK-BASED PREMIUM.—Lenders shall reduce by 50 percent the risk-based premium to
p.000989: eligible borrowers if a credit worthy parent or other responsible party co-signs the loan note.
p.000989: (d) ADMINISTRATIVE WAIVERS.—
p.000989: (1) HEARING.—The Secretary shall afford an institution not less than one hearing, and may consider
p.000989: mitigating cir- cumstances, prior to making such institution ineligible for par- ticipation in the program under this
p.000989: subpart.
p.000989: (2) EXCEPTIONS.—In carrying out this section with respect to an institution, the Secretary may grant an
p.000989: institution a waiver of requirements of paragraphs (2) through (4) of sub- section (b) if the Secretary
p.000989: determines that the default rate for such institution is not an accurate indicator because the vol- ume of
p.000989: the loans under this subpart made by such institution has been insufficient.
p.000989: (3) TRANSITION FOR CERTAIN INSTITUTIONS.—During the 3- year period beginning on the effective date of the
p.000989: Health Pro- fessions Education Extension Amendments of 1992—
p.000989: (A) subsection (b)(4) shall not apply with respect to any eligible institution that is a Historically Black
p.000989: College or University; and
p.000989: (B) any such institution that has a default rate in ex- cess of 20 percent, and any eligible borrower seeking
p.000989: a loan for attendance at the institution, shall be subject to subsection (b)(3) to the same extent and in the
p.000989: same man- ner as eligible institutions and borrowers described in such subsection.
p.000989: (e) PAYOFF TO REDUCE RISK CATEGORY.—An institution may pay off the outstanding principal and interest
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p.001033: (a) ESTABLISHMENT OF AWARDS.—The Secretary shall make the following 2 types of awards in accordance with this section:
p.001033: (1) INFRASTRUCTURE DEVELOPMENT AWARD.—The Secretary shall make awards to eligible entities to enable such
p.001033: entities to initiate health care workforce educational programs or to continue to carry out comparable
p.001033: programs that are operating at the time the award is made by planning, developing, oper- ating, and
p.001033: evaluating an area health education center pro- gram.
p.001033: (2) POINT OF SERVICE MAINTENANCE AND ENHANCEMENT AWARD.—The Secretary shall make awards to eligible
p.001033: entities to maintain and improve the effectiveness and capabilities of an existing area health education
p.001033: center program, and make other modifications to the program that are appropriate due to changes in demographics,
p.001033: needs of the populations served, or other similar issues affecting the area health education center program. For
p.001033: the purposes of this section, the term ‘‘Program’’ refers to the area health education center program.
p.001033: (b) ELIGIBLE ENTITIES; APPLICATION.—
p.001033: (1) ELIGIBLE ENTITIES.—
p.001033: (A) INFRASTRUCTURE DEVELOPMENT.—For purposes of subsection (a)(1), the term ‘‘eligible entity’’ means a school of
p.001033: medicine or osteopathic medicine, an incorporated con- sortium of such schools, or the parent institutions
p.001033: of such a school. With respect to a State in which no area health education center program is in
p.001033: operation, the Secretary may award a grant or contract under subsection (a)(1) to a school of nursing.
p.001033: (B) POINT OF SERVICE MAINTENANCE AND ENHANCE- MENT.—For purposes of subsection (a)(2), the term ‘‘eligible
p.001033: entity’’ means an entity that has received funds under this section, is operating an area health education
p.001033: center pro- gram, including an area health education center or cen- ters, and has a center or centers that are
p.001033: no longer eligible to receive financial assistance under subsection (a)(1).
p.001033: (2) APPLICATION.—An eligible entity desiring to receive an award under this section shall submit to the
p.001033: Secretary an ap- plication at such time, in such manner, and containing such in- formation as the Secretary may
p.001033: require.
p.001033: (c) USE OF FUNDS.—
p.001033: (1) REQUIRED ACTIVITIES.—An eligible entity shall use amounts awarded under a grant under subsection
p.001033: (a)(1) or (a)(2) to carry out the following activities:
p.001033: (A) Develop and implement strategies, in coordination with the 10applicable one-stop delivery system under sec-
p.001033: tion 134(c) of the Workforce Investment Act of 1998, to re- cruit individuals from underrepresented minority popu-
p.001033: lations or from disadvantaged or rural backgrounds into
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p.001035:
p.001035: Sec. 751 PUBLIC HEALTH SERVICE ACT 1036
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p.001035: (C) Develop and implement other strategies to address identified workforce needs and increase and enhance the
p.001035: health care workforce in the area served by the area health education center program.
p.001035: (d) REQUIREMENTS.—
p.001035: (1) AREA HEALTH EDUCATION CENTER PROGRAM.—In car- rying out this section, the Secretary shall ensure the
p.001035: following:
p.001035: (A) An entity that receives an award under this sec- tion shall conduct at least 10 percent of
p.001035: clinical education required for medical students in community settings that are removed from the primary
p.001035: teaching facility of the con- tracting institution for grantees that operate a school of medicine or
p.001035: osteopathic medicine. In States in which an entity that receives an award under this section is a nurs- ing
p.001035: school or its parent institution, the Secretary shall al- ternatively ensure that—
p.001035: (i) the nursing school conducts at least 10 percent of clinical education required for nursing students in
p.001035: community settings that are remote from the primary teaching facility of the school; and
p.001035: (ii) the entity receiving the award maintains a written agreement with a school of medicine or osteo-
p.001035: pathic medicine to place students from that school in training sites in the area health education center pro-
p.001035: gram area.
p.001035: (B) An entity receiving funds under subsection (a)(2) does not distribute such funding to a center that is
p.001035: eligible to receive funding under subsection (a)(1).
p.001035: (2) AREA HEALTH EDUCATION CENTER.—The Secretary shall ensure that each area health education center program
p.001035: in- cludes at least 1 area health education center, and that each such center—
p.001035: (A) is a public or private organization whose structure, governance, and operation is independent from the award- ee
p.001035: and the parent institution of the awardee;
p.001035: (B) is not a school of medicine or osteopathic medicine, the parent institution of such a school, or a branch campus or
p.001035: other subunit of a school of medicine or osteopathic medicine or its parent institution, or a consortium of
p.001035: such entities;
p.001035: (C) designates an underserved area or population to be served by the center which is in a location removed
p.001035: from the main location of the teaching facilities of the schools participating in the program with such center
p.001035: and does not duplicate, in whole or in part, the geographic area or popu- lation served by any other center;
p.001035: (D) fosters networking and collaboration among com- munities and between academic health centers and com-
p.001035: munity-based centers;
p.001035: (E) serves communities with a demonstrated need of health professionals in partnership with academic medical
p.001035: centers;
p.001035: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001037: PUBLIC HEALTH SERVICE ACT
p.001037: Sec. 751
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p.001051: the costs of projects to establish, maintain, or improve faculty development, or departments, divisions, or
p.001051: other units nec- essary to implement such program.
p.001051: (3) ACADEMIC UNITS OR PROGRAMS.—A recipient of a grant under subsection (a)(3) shall enter into a partnership
p.001051: with or- ganizations such as an education accrediting organization (such as the Liaison Committee on
p.001051: Medical Education, the Ac- creditation Council for Graduate Medical Education, the Com- mission on Osteopathic
p.001051: College Accreditation, the Accreditation Commission for Education in Nursing, the Commission on Col- legiate Nursing
p.001051: Education, the Accreditation Council for Phar- macy Education, the Council on Social Work Education, Amer- ican
p.001051: Psychological Association Commission on Accreditation, or the Accreditation Review Commission on Education for
p.001051: the Physician Assistant) to carry out activities under subsection (a)(3).
p.001051: (c) ELIGIBLE ENTITIES.—
p.001051: (1) TRAINING FOR RESIDENTS AND FELLOWS.—To be eligible to receive a grant under subsection (a)(1), an entity shall—
p.001051: (A) be a consortium consisting of—
p.001051: (i) at least one teaching health center; and
p.001051: (ii) the sponsoring institution (or parent institu- tion of the sponsoring institution) of—
p.001051: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001053: PUBLIC HEALTH SERVICE ACT
p.001053: Sec. 760
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p.001053: (I) a psychiatry residency program that is ac- credited by the Accreditation Council of Graduate Medical
p.001053: Education (or the parent institution of such a program); or
p.001053: (II) a fellowship in addiction medicine, as de- termined appropriate by the Secretary; or
p.001053: (B) be an entity described in subparagraph (A)(ii) that provides opportunities for residents or fellows to train
p.001053: in community-based settings that integrate primary care with mental and substance use disorders prevention and
p.001053: treat- ment services.
p.001053: (2) TRAINING FOR OTHER PROVIDERS.—To be eligible to re- ceive a grant under subsection (a)(2), an entity shall
p.001053: be—
p.001053: (A) a teaching health center (as defined in section 749A(f));
p.001053: (B) a Federally qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act);
p.001053: (C) a community mental health center (as defined in section 1861(ff)(3)(B) of the Social Security Act);
p.001053: (D) a rural health clinic (as defined in section 1861(aa) of the Social Security Act);
p.001053: (E) a health center operated by the Indian Health Service, an Indian tribe, a tribal organization, or an urban
p.001053: Indian organization (as defined in section 4 of the Indian Health Care Improvement Act); or
p.001053: (F) an entity with a demonstrated record of success in providing training for nurse practitioners, physician assist-
p.001053: ants, health service psychologists, and social workers.
p.001053: (3) ACADEMIC UNITS OR PROGRAMS.—To be eligible to re- ceive a grant under subsection (a)(3), an
p.001053: entity shall be a school of medicine or osteopathic medicine, a nursing school, a physician assistant training
p.001053: program, a school of pharmacy, a school of social work, an accredited public or nonprofit private hospital, an
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p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: Sec. 1252 PUBLIC HEALTH SERVICE ACT 1198
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p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
p.001197: support, peer mentoring, and parent to parent programs.
p.001197: (D) To develop individual and family service coordina- tion or case management systems.
p.001197: (E) To support other needs identified by the advisory board under subsection (b) for the State or
p.001197: American In- dian consortium involved.
p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
p.001197: (A) educate consumers and families;
p.001197: (B) train professionals in public and private sector fi- nancing (such as third party payers, State
p.001197: agencies, com- munity-based providers, schools, and educators);
p.001197: (C) develop or improve case management or service co- ordination systems;
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p.001235: maintenance or- ganization, any person who is directly or indirectly the bene- ficial owner of more than 5 per
p.001235: centum of the equity of the or- ganization, any person who is the beneficial owner of a mort- gage, deed of
p.001235: trust, note, or other interest secured by, and val- uing more than 5 per centum of the health maintenance orga-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001237: PUBLIC HEALTH SERVICE ACT
p.001237: Sec. 1318
p.001237:
p.001237: nization, and, in the case of a health maintenance organization organized as a nonprofit corporation, an
p.001237: incorporator or mem- ber of such corporation under applicable State corporation law;
p.001237: (2) any entity in which a person described in paragraph (1)—
p.001237: (A) is an officer or director;
p.001237: (B) is a partner (if such entity is organized as a part- nership);
p.001237: (C) has directly or indirectly a beneficial interest of more than 5 per centum of the equity; or
p.001237: (D) has a mortgage, deed of trust, note, or other inter- est valuing more than 5 per centum of the assets of
p.001237: such entity;
p.001237: (3) any person directly or indirectly controlling, controlled by, or under common control with a health
p.001237: maintenance orga- nization; and
p.001237: (4) any spouse, child, or parent of an individual described in paragraph (1).
p.001237: (c) Each health maintenance organization shall make the infor- mation reported pursuant to subsection (a) available to
p.001237: its enrollees upon reasonable request.
p.001237: (d) The Secretary shall, as he deems necessary, conduct an evaluation of transactions reported to the
p.001237: Secretary under sub- section (a)(3) for the purpose of determining their adverse impact, if any, on the
p.001237: fiscal soundness and reasonableness of charges to the health maintenance organization with respect to which they
p.001237: tran- spired. The Secretary shall evaluate the reported transactions of not less than five, or if there are
p.001237: more than twenty health mainte- nance organizations reporting such transactions, not less than one- fourth of the
p.001237: health maintenance organizations reporting any such transactions under subsection (a)(3).
p.001237: (f) 4 Nothing in this section shall be construed to confer upon the Secretary any authority to approve
p.001237: or disapprove the rates charged by any health maintenance organization.
p.001237: (g) Any health maintenance organization failing to file with the Secretary the annual financial statement required in
p.001237: subsection (a) shall be ineligible for any Federal assistance under this title until such time as such
p.001237: statement is received by the Secretary and shall not be a qualified health maintenance organization for purposes of
p.001237: section 1310.
p.001237: (h) Whoever knowingly and willfully makes or causes to be made any false statement or representation of
p.001237: a material fact in any statement filed pursuant to this section shall be guilty of a fel- ony and upon conviction
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p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
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p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
p.001343: care services in a single setting or the capability of creating a network through which all care services
p.001343: would be provided; or
p.001343: (B) in the case of an organization which will provide prevention services, the capability of providing
p.001343: such serv- ices;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: of such services; and
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p.001351: (ii) in the case of a pregnant unemancipated minor re- questing services from the applicant, the applicant will no-
p.001351: tify the parents or guardians of such minor under clause
p.001351: (i) within a reasonable period of time;
p.001351: (B) assurances that the applicant will not notify or request the permission of the parents or
p.001351: guardian of any unemancipated minor without the consent of the minor—
p.001351: (i) who solely is requesting from the applicant preg- nancy testing or testing or treatment for venereal
p.001351: disease;
p.001351: (ii) who is the victim of incest involving a parent; or
p.001351: (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor
p.001351: by blood certifies to the grantee that notification of the parents or guardians of such minor would result in
p.001351: physical injury to such minor; and
p.001351: (C) assurances that the applicant will not require, with re- spect to the provision of services, the permission of the
p.001351: parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to
p.001351: compel such minor to have an abortion;
p.001351: (23) assurances that primary emphasis for services sup- ported under this title shall be given to
p.001351: adolescents seventeen and under who are not able to obtain needed assistance through other means;
p.001351: (24) assurances that funds received under this title shall supplement and not supplant funds received
p.001351: from any other Federal, State, or local program or any private sources of funds; and
p.001351: (25) a plan for the conduct of, and assurances that the ap- plicant will conduct, evaluations of the
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p.001357:
p.001357: January 30, 2020
p.001357:
p.001357: PLAN
p.001357: SEC. 2103. ø300aa–3¿ The Director of the Program shall pre- pare and issue a plan for the implementation of
p.001357: the responsibilities of the Director under section 2102. The plan shall establish prior- ities in research
p.001357: and the development, testing, licensing, produc- tion, procurement, distribution, and effective use of
p.001357: vaccines, de- scribe an optimal use of resources to carry out such priorities, and
p.001357: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001357:
p.001357:
p.001357:
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p.001357:
p.001357: Sec. 2105 PUBLIC HEALTH SERVICE ACT 1358
p.001357:
p.001357: describe how each of the various departments and agencies will carry out their vaccine functions in
p.001357: consultation and coordination with the Program and in conformity with such priorities. The first plan under this
p.001357: section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each
p.001357: suc- ceeding year.
p.001357: NATIONAL VACCINE ADVISORY COMMITTEE
p.001357: SEC. 2105. 1 ø300aa–5¿ (a) There is established the National Vaccine Advisory Committee. The members of the
p.001357: Committee shall be appointed by the Director of the Program, in consultation with the National Academy of
p.001357: Sciences, from among individuals who are engaged in vaccine research or the manufacture of vaccines or who are
p.001357: physicians, members of parent organizations concerned with immunizations, or representatives of State or local
p.001357: health agencies or public health organizations.
p.001357: (b) The Committee shall—
p.001357: (1) study and recommend ways to encourage the avail- ability of an adequate supply of safe and
p.001357: effective vaccination products in the States,
p.001357: (2) recommend research priorities and other measures the Director of the Program should take to enhance the safety and
p.001357: efficacy of vaccines,
p.001357: (3) advise the Director of the Program in the implementa- tion of sections 2102, 2103, and 2104 1, and
p.001357: (4) identify annually for the Director of the Program the most important areas of government and
p.001357: non-government co- operation that should be considered in implementing sections 2102, 2103, and 2104 1.
p.001357: AUTHORIZATIONS
p.001357: SEC. 2106. ø300aa–6¿ (a) To carry out this subtitle other than section 2102(9) there are authorized to be appropriated
p.001357: such sums as may be necessary for each of the fiscal years 2004 and 2005.
p.001357: (b) To carry out section 2102(9) there are authorized to be ap- propriated such sums as may be necessary for
p.001357: each of the fiscal years 2004 and 2005.
p.001357: Subtitle 2—National Vaccine Injury Compensation Program PART A—PROGRAM REQUIREMENTS
p.001357: ESTABLISHMENT OF PROGRAM
p.001357: SEC. 2110. ø300aa–10¿ (a) PROGRAM ESTABLISHED.—There is
p.001357: established the National Vaccine Injury Compensation Program to be administered by the Secretary under
p.001357: which compensation may be paid for a vaccine-related injury or death.
p.001357: (b) ATTORNEY’S OBLIGATION.—It shall be the ethical obligation of any attorney who is consulted by an
...

p.001385: section also repealed section 1717, which related to effective dates.)
p.001385: Section 102(b) of Public Law 108–7 provided as follows: ‘‘The Public Health Service Act (42
p.001385: U.S.C. 201 et seq.) shall be applied and administered as if the sections repealed by subsection
p.001385: (a) had never been enacted.’’. Consistent with that provision, section 2133 is shown above to re- flect the
p.001385: assumption that repealing a provision of law that makes a change in an Act has the effect of amending
p.001385: that Act so as to undo the change.
p.001385: Section 102(c) of such Public Law provides as follows: ‘‘No inference shall be drawn from the enactment of sections
p.001385: 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107- 296), or from this repeal, regarding the
p.001385: law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law
p.001385: 107-296). Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or
p.001385: that Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11,
p.001385: 2002), was incorrectly decided.’’.
p.001385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001385:
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p.001385:
p.001385:
p.001387: 1387
p.001387: PUBLIC HEALTH SERVICE ACT
p.001387: Sec. 2134
p.001387:
p.001387: (2) The term ‘‘legal representative’’ means a parent or an individual who qualifies as a legal guardian
p.001387: under State law.
p.001387: (3) The term ‘‘manufacturer’’ means any corporation, orga- nization, or institution, whether public or private
p.001387: (including Federal, State, and local departments, agencies, and instru- mentalities), which manufactures,
p.001387: imports, processes, or dis- tributes under its label any vaccine set forth in the Vaccine In- jury Table, except
p.001387: that, for purposes of section 2128, such term shall include the manufacturer of any other vaccine covered by that
p.001387: section. The term ‘‘manufacture’’ means to manufacture, import, process, or distribute a vaccine.
p.001387: (4) The term ‘‘significant aggravation’’ means any change for the worse in a preexisting condition which results
p.001387: in mark- edly greater disability, pain, or illness accompanied by sub- stantial deterioration of health.
p.001387: (5) The term ‘‘vaccine-related injury or death’’ means an illness, injury, condition, or death associated with
p.001387: one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include
p.001387: an illness, injury, condition, or death associated with an adulterant or contaminant inten- tionally added
p.001387: to such a vaccine.
p.001387: (6)(A) The term ‘‘Advisory Commission on Childhood Vac- cines’’ means the Commission established under
p.001387: section 2119.
p.001387: (B) The term ‘‘Vaccine Injury Table’’ means the table set out in section 2114.
p.001387: TERMINATION OF PROGRAM
...

p.001649: the State’s programs under this title;
p.001649: (B) is an aging and disability resource center;
p.001649: (C) works in collaboration with a public or private nonprofit statewide respite care coalition or
p.001649: organization; and
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p.001649: January 30, 2020
p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
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p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
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p.000105: been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be
p.000105: submitted in such manner as the Secretary shall prescribe and shall include each of the following:
p.000105: (1) A complete description of the program which is to be provided by or through the applicant.
p.000105: (2) Assurances satisfactory to the Secretary that the pro- gram to be provided under the grant applied
p.000105: for will include educational programs designed to—
p.000105: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000105:
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p.000105: Sec. 317A PUBLIC HEALTH SERVICE ACT 106
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p.000105: January 30, 2020
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p.000105: (A) communicate to parents, educators, and local health officials the significance and prevalence of lead
p.000105: poi- soning in infants and children (including the sources of lead exposure, the importance of screening young
p.000105: children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which
p.000105: the program is designed to detect and prevent; and
p.000105: (B) communicate to health professionals and para- professionals updated knowledge concerning lead poisoning and
p.000105: research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning
p.000105: among all socioeconomic groupings; the benefits of ex- panded lead screening; and the therapeutic
p.000105: and other interventions available to prevent and combat lead poi- soning in affected children and families).
p.000105: (3) Assurances satisfactory to the Secretary that the appli- cant will report on a quarterly basis the number of
p.000105: infants and children screened for elevated blood lead levels, the number of infants and children who were found
p.000105: to have elevated blood lead levels, the number and type of medical referrals made for such infants and children,
p.000105: the outcome of such referrals, and other information to measure program effectiveness.
p.000105: (4) Assurances satisfactory to the Secretary that the appli- cant will make such reports respecting the program
p.000105: involved as the Secretary may require.
p.000105: (5) Assurances satisfactory to the Secretary that the appli- cant will coordinate the activities carried out pursuant
p.000105: to sub- section (a) with related activities and services carried out in the State by grantees under title V or
p.000105: XIX of the Social Secu- rity Act.
...

p.000227: a covered countermeasure, means—
p.000227: (A) the United States; or
p.000227: (B) a person or entity that is—
p.000227: (i) a manufacturer of such countermeasure;
p.000227: (ii) a distributor of such countermeasure;
p.000227: (iii) a program planner of such countermeasure;
p.000227: (iv) a qualified person who prescribed, adminis- tered, or dispensed such countermeasure; or
p.000227: (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).
p.000227: (3) DISTRIBUTOR.—The term ‘‘distributor’’ means a person or entity engaged in the distribution of drugs,
p.000227: biologics, or de- vices, including but not limited to manufacturers; repackers; common carriers; contract
p.000227: carriers; air carriers; own-label dis- tributors; private-label distributors; jobbers; brokers; ware-
p.000227: houses, and wholesale drug warehouses; independent whole- sale drug traders; and retail pharmacies.
p.000227: (4) MANUFACTURER.—The term ‘‘manufacturer’’ includes—
p.000227: (A) a contractor or subcontractor of a manufacturer;
p.000227: (B) a supplier or licenser of any product, intellectual property, service, research tool, or component or other
p.000227: arti- cle used in the design, development, clinical testing, inves- tigation, or manufacturing of a covered
p.000227: countermeasure; and
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p.000227: (C) any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
p.000227: (5) PERSON.—The term ‘‘person’’ includes an individual, partnership, corporation, association, entity, or
p.000227: public or pri- vate corporation, including a Federal, State, or local govern- ment agency or department.
p.000227: (6) PROGRAM PLANNER.—The term ‘‘program planner’’ means a State or local government, including an
p.000227: Indian tribe, a person employed by the State or local government, or other person who supervised or
p.000227: administered a program with respect to the administration, dispensing, distribution, provision, or use of a
p.000227: security countermeasure or a qualified pandemic or epidemic product, including a person who has
p.000227: established re- quirements, provided policy guidance, or supplied technical or scientific advice or
p.000227: assistance or provides a facility to admin- ister or use a covered countermeasure in accordance with a
p.000227: declaration under subsection (b).
p.000227: (7) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘‘qualified pandemic or epidemic product’’ means a drug
p.000227: (as such term is defined in section 201(g)(1) of the Federal Food,
p.000227: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000227:
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p.000227: Sec. 319F–4 PUBLIC HEALTH SERVICE ACT 228
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p.000283: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000283: to be appropriated such sums as may be necessary for each of the fiscal years 2000 through 2004.
p.000283: SEC. 330E. ø254c–5¿ EPILEPSY; SEIZURE DISORDER.
p.000283: (a) NATIONAL PUBLIC HEALTH CAMPAIGN.—
p.000283: (1) IN GENERAL.—The Secretary shall develop and imple- ment public health surveillance, education, research, and
p.000283: inter- vention strategies to improve the lives of persons with epilepsy, with a particular emphasis on children.
p.000283: Such projects may be carried out by the Secretary directly and through awards of grants or contracts to
p.000283: public or nonprofit private entities. The Secretary may directly or through such awards provide tech-
p.000283: nical assistance with respect to the planning, development, and operation of such projects.
p.000283: (2) CERTAIN ACTIVITIES.—Activities under paragraph (1) shall include—
p.000283: (A) expanding current surveillance activities through existing monitoring systems and improving registries
p.000283: that maintain data on individuals with epilepsy, including chil- dren;
p.000283: (B) enhancing research activities on the diagnosis, treatment, and management of epilepsy;
p.000283: (C) implementing public and professional information and education programs regarding epilepsy, including
p.000283: ini- tiatives which promote effective management of the dis- ease through children’s programs which are
p.000283: targeted to parents, schools, daycare providers, patients;
p.000283: (D) undertaking educational efforts with the media, providers of health care, schools and others regarding stig-
p.000283: mas and secondary disabilities related to epilepsy and sei- zures, and its effects on youth;
p.000283: (E) utilizing and expanding partnerships with organi- zations with experience addressing the health and
p.000283: related needs of people with disabilities; and
p.000283: (F) other activities the Secretary deems appropriate.
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000283:
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p.000283: Sec. 330F PUBLIC HEALTH SERVICE ACT 284
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p.000283: January 30, 2020
p.000283:
p.000283: (3) COORDINATION OF ACTIVITIES.—The Secretary shall en- sure that activities under this subsection are
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p.000287: (A) IN GENERAL.—With respect to the costs of the ac- tivities to be carried out by an entity pursuant
p.000287: to para- graph (1), a condition for the receipt of a grant under such paragraph is that the entity agree to
p.000287: make available (di- rectly or through donations from public or private entities) non-Federal contributions toward
p.000287: such costs in an amount that is not less than 25 percent of such costs.
p.000287: (B) DETERMINATION OF AMOUNT CONTRIBUTED.—Non- Federal contributions under subparagraph (A) may be in cash
p.000287: or in kind, fairly evaluated, including plant, equip- ment, or services. Amounts provided by the Federal
p.000287: Gov- ernment, or services assisted or subsidized to any signifi- cant extent by the Federal Government,
p.000287: may not be in- cluded in determining the amount of such contributions.
p.000287: (b) NATIONAL RESOURCES PROGRAM.—The Secretary shall (di- rectly or through grant or contract) carry out
p.000287: a program that, through toll-free telecommunications, makes available to the public information regarding the
p.000287: adoption of children with special needs. Such information shall include the following:
p.000287: (1) A list of national, State, and regional organizations that provide services regarding such adoptions,
p.000287: including ex- changes and other information on communicating with the or- ganizations. The list shall
p.000287: represent the full national diversity of adoption organizations.
p.000287: (2) Information beneficial to individuals who adopt such children, including lists of support groups for
p.000287: adoptive parents and other postadoptive services.
p.000287: (c) OTHER PROGRAMS.—With respect to the adoption of children with special needs, the Secretary shall make grants—
p.000287: (1) to provide assistance to support groups for adoptive parents, adopted children, and siblings of
p.000287: adopted children; and
p.000287: (2) to carry out studies to identify—
p.000287: (A) the barriers to completion of the adoption process;
p.000287: and
p.000287: (B) those components that lead to favorable long-term
p.000287:
p.000287:
p.000287:
p.000287:
p.000287:
p.000287: January 30, 2020
p.000287: outcomes for families that adopt children with special needs.
p.000287: (d) APPLICATION FOR GRANT.—The Secretary may make an award of a grant or contract under this section
p.000287: only if an applica- tion for the award is submitted to the Secretary and the applica-
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: PUBLIC HEALTH SERVICE ACT
p.000289: Sec. 330H
p.000289:
p.000289: tion is in such form, is made in such manner, and contains such agreements, assurances, and information
p.000289: as the Secretary deter- mines to be necessary to carry out this section.
p.000289: (e) FUNDING.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as
p.000289: may be nec- essary for each of the fiscal years 2001 through 2005.
p.000289: SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
p.000289: (a) IN GENERAL.—
p.000289: (1) CONTINUATION AND EXPANSION OF PROGRAM.—The Sec- retary, acting through the Administrator of the Health
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p.000487: such payments.
p.000487: (B)(i) In the case of an organization making an agree- ment under subparagraph (A)(ii) regarding the provision of
p.000487: services under paragraph (1), the requirement established in such subparagraph regarding a participation
p.000487: agreement shall be waived by the Secretary if the organization does not, in providing health or mental health
p.000487: services, impose a charge or accept reimbursement available from any third-party payor, including
p.000487: reimbursement under any in- surance policy or under any Federal or State health bene- fits program.
p.000487: (ii) A determination by the Secretary of whether an or- ganization referred to in clause (i) meets the criteria for a
p.000487: waiver under such clause shall be made without regard to whether the organization accepts voluntary donations re-
p.000487: garding the provision of services to the public.
p.000487: (b) HOME VISITING SERVICES FOR ELIGIBLE FAMILIES.—With re- spect to an eligible family, each of the
p.000487: following services shall, di- rectly or through arrangement with other public or nonprofit pri- vate
p.000487: entities, be available (as applicable to the family member in- volved) in each project operated with a grant
p.000487: under subsection (a):
p.000487: (1) Prenatal and postnatal health care.
p.000487: (2) Primary health care for the children, including develop- mental assessments.
p.000487: (3) Education for the parents concerning infant care and child development, including the development and
p.000487: utilization of parent and teacher resource networks and other family re- source and support networks where
p.000487: such networks are avail- able.
p.000487: (4) Upon the request of a parent, providing the education described in paragraph (3) to other
p.000487: individuals who have re- sponsibility for caring for the children.
p.000487: (5) Education for the parents concerning behaviors that ad- versely affect health.
p.000487: (6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and
p.000487: nutrition services and other assistance, including services and other assistance under maternal and child
p.000487: health programs; the special supple- mental nutrition program for women, infants, and children; section 17 of
p.000487: the Child Nutrition Act of 1966; title V of the So- cial Security Act; title XIX of such Act (including the program for
p.000487: early and periodic screening, diagnostic, and treatment services described in section 1905(r) of such Act);
p.000487: titles IV and XIX of the Social Security Act; housing programs; other food assistance programs; and
p.000487: appropriate alcohol and drug depend- ency treatment programs, according to need.
p.000487: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000489: PUBLIC HEALTH SERVICE ACT
p.000489: Sec. 399
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p.000497: agrees that for each fiscal year for which the applicant receives such a grant the applicant, in
p.000497: accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
p.000497: (1) a description of specific services and activities provided under the grant;
p.000497: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000497: (3) information concerning the extent of use of services provided under the grant, including the number of
p.000497: referrals to
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000497: Sec. 399A PUBLIC HEALTH SERVICE ACT 498
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p.000497: related services and information on other programs or services accessed by children, parents, and other caretakers;
p.000497: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and
p.000497: drug abuse and sustain participation in treatment over time until the provider and the individual
p.000497: receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after
p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
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p.000499: PUBLIC HEALTH SERVICE ACT
p.000499: Sec. 399A
p.000499:
p.000499: the Substance Abuse and Mental Health Services Adminis- tration, and the Administration for Children, Youth, and
p.000499: Families.
p.000499: (l) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000499: programs supported under subsection (a)—
p.000499: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000499: (2) in preventing adverse health conditions in children of substance abusers;
p.000499: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000499: developmental, and psychological status of children receiving services under the program;
p.000499: (4) in improving parental and family functioning;
p.000499: (5) in reducing the incidence of out-of-home placement for children whose parents receive services under
p.000499: the program; and
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p.000499: (6) in facilitating the reunification of families after chil- dren have been placed in out-of-home care.
p.000499: (m) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000499: subjection (o), the Secretary shall prepare and submit to the Committee on En- ergy and Commerce of the
p.000499: House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains
p.000499: a description of programs carried out under this sec- tion. At a minimum, the report shall contain—
p.000499: (1) information concerning the number and type of pro- grams receiving grants;
p.000499: (2) information concerning the type and use of services of- fered;
p.000499: (3) information concerning—
p.000499: (A) the number and characteristics of families, par- ents, and children served;
p.000499: (B) the number of children served who remained with their parents during or after the period in which entities
p.000499: provided services under this section;
p.000499: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000499: vided services under this section;
p.000499: (D) the number of children described in subparagraph
p.000499: (C) who were reunited with their families; and
p.000499: (E) the number of children described in subparagraph
p.000499: (C) who were permanently placed in out-of-home care; analyzed by the type of entity described in subsection (d) that
p.000499: provided services;
p.000499: (4) an analysis of the access provided to, and use of, re- lated services and alcohol and drug
p.000499: treatment through pro- grams carried out under this section; and
p.000499: (5) a comparison of the costs of providing services through each of the types of entities described in subsection (d).
p.000499: (n) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: disabilities, and sub- stance abuse in planning and providing services under this sec- tion, as well as evidence that
p.000505: the proposal has been coordinated with the State agencies responsible for administering those pro- grams, the State
p.000505: agency responsible for administering alcohol and drug programs, the State lead agency, and the State Inter- agency
p.000505: Coordinating Council under part H of the Individuals with Disabilities Education Act; and; 96
p.000505: (3) such other information as the Secretary determines to be appropriate.
p.000505: (i) REPORTS TO SECRETARY.—The Secretary may make a grant under subsection (a) only if the applicant
p.000505: involved agrees that for each fiscal year for which the applicant receives such a grant the applicant,
p.000505: in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report
p.000505: containing—
p.000505: (1) a description of specific services and activities provided under the grant;
p.000505: (2) information regarding progress toward meeting the pro- gram’s stated goals and objectives;
p.000505: (3) information concerning the extent of use of services pro- vided under the grant, including the number of referrals
p.000505: to re- lated services and information on other programs or services accessed by children, parents, and other
p.000505: caretakers;
p.000505: (4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug
p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
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p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
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p.000505: (1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
p.000505: (2) in preventing adverse health conditions in children of substance abusers;
p.000505: (3) in promoting better utilization of health and develop- mental services and improving the health,
p.000505: developmental, and psychological status of children receiving services under the program; and
p.000505: (4) in improving parental and family functioning, includ- ing increased participation in work or
p.000505: employment-related ac- tivities and decreased participation in welfare programs.
p.000505: (l) REPORT TO CONGRESS.—Not later than 2 years after the date on which amounts are first appropriated under
p.000505: subjection (o), the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of
p.000505: Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a
p.000505: description of programs carried out under this section. At a min- imum, the report shall contain—
p.000505: (1) information concerning the number and type of pro- grams receiving grants;
p.000505: (2) information concerning the type and use of services of- fered; and
p.000505: (3) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served; and
p.000505: (B) the number of children served who remained with their parents during or after the period in which
p.000505: entities provided services under this section. 97
p.000505: analyzed by the type of entity described in subsection (d) 98 that pro- vided services; 99
p.000505: (m) DATA COLLECTION.—The Secretary shall periodically collect and report on information concerning the numbers
p.000505: of children in substance abusing families, including information on the age, gen- der and ethnicity of the
p.000505: children, the composition and income of the family, and the source of health care finances. The periodic
p.000505: report
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p.000505: January 30, 2020
p.000505: 97 The period at the end of subparagraph (B), and the semicolon at the end of paragraph (3), would be
p.000505: so in law. See section 3106(h) of Public Law 106–310 (114 Stat. 1178). The period prob- ably should be a semicolon, and
p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
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p.000523: the fiscal years 1999 through 2003.
p.000523: (b) TASK FORCE.—From amounts appropriated for a fiscal year under subsection (a), the Secretary may use
p.000523: not to exceed
p.000523: $2,000,000 of such amounts for the operations of the National Task Force under section 399H(d).
p.000523: SEC. 399K. ø280f–3¿ SUNSET PROVISION.
p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
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p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
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p.000531: (2) POLICY DEVELOPMENT.—The Administrator of the Health Resources and Services Administration, the Director
p.000531: of the Centers for Disease Control and Prevention, and the Direc- tor of the National Institutes of Health shall
p.000531: coordinate and collaborate on recommendations for policy development at the Federal and State levels and with
p.000531: the private sector, including consumer, medical and other health and education profes- sional-based
p.000531: organizations, with respect to newborn and infant hearing screening, evaluation, diagnosis, and intervention pro- grams
p.000531: and systems.
p.000531: (3) STATE EARLY DETECTION, DIAGNOSIS, AND INTERVENTION PROGRAMS AND SYSTEMS; DATA COLLECTION.—The
p.000531: Adminis- trator of the Health Resources and Services Administration and the Director of the Centers for
p.000531: Disease Control and Pre- vention shall coordinate and collaborate in assisting States—
p.000531: (A) to establish newborn, infant, and young child hear- ing screening, evaluation, diagnosis, and intervention
p.000531: pro- grams and systems under subsection (a); and
p.000531: (B) to develop a data collection system under sub- section (b).
p.000531: (d) RULE OF CONSTRUCTION; RELIGIOUS ACCOMMODATION.— Nothing in this section shall be construed to
p.000531: preempt or prohibit any State law, including State laws that do not require the screen- ing for hearing loss of
p.000531: children of parents who object to the screen- ing on the grounds that such screening conflicts with the
p.000531: parent’s religious beliefs.
p.000531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000531:
p.000531: (e) DEFINITIONS.—For purposes of this section:
p.000531: (1) The term ‘‘audiologic’’, when used in connection with evaluation, means procedures—
p.000531: (A) to assess the status of the auditory system;
p.000531: (B) to establish the site of the auditory disorder, the type and degree of hearing loss, and the
p.000531: potential effects of hearing loss on communication; and
p.000531: (C) to identify appropriate treatment and referral op- tions, including—
p.000531: (i) linkage to State coordinating agencies under part C of the Individuals with Disabilities Education Act
p.000531: or other appropriate agencies;
p.000531: (ii) medical evaluation;
p.000531: (iii) assessment for the full range of assistive hearing technologies appropriate for newborns,
p.000531: in- fants, and young children;
p.000531: (iv) audiologic rehabilitation treatment; and
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p.000551: factors.
p.000551: (b) INFORMATION AND SUPPORT SERVICES.—
p.000551: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the National Institutes of Health, the Director
p.000551: of the Centers for Disease Control and Prevention, or the Adminis- trator of the Health Resources and
p.000551: Services Administration, may authorize and oversee certain activities, including the awarding of grants,
p.000551: contracts or cooperative agreements to eli- gible entities, to—
p.000551: (A) collect, synthesize, and disseminate current evi- dence-based information relating to Down syndrome or
p.000551: other prenatally or postnatally diagnosed conditions; and
p.000551: (B) coordinate the provision of, and access to, new or existing supportive services for patients
p.000551: receiving a posi-
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p.000551: Sec. 399T PUBLIC HEALTH SERVICE ACT 552
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p.000551: tive diagnosis for Down syndrome or other prenatally or postnatally diagnosed conditions, including—
p.000551: (i) the establishment of a resource telephone hot- line accessible to patients receiving a positive test
p.000551: re- sult or to the parents of newly diagnosed infants with Down syndrome and other diagnosed conditions;
p.000551: (ii) the expansion and further development of the National Dissemination Center for Children with Dis-
p.000551: abilities, so that such Center can more effectively con- duct outreach to new and expecting parents and pro-
p.000551: vide them with up-to-date information on the range of outcomes for individuals living with the diagnosed
p.000551: condition, including physical, developmental, edu- cational, and psychosocial outcomes;
p.000551: (iii) the expansion and further development of na- tional and local peer-support programs, so that such programs
p.000551: can more effectively serve women who re- ceive a positive diagnosis for Down syndrome or other prenatal
p.000551: conditions or parents of infants with a postnatally diagnosed condition;
p.000551: (iv) the establishment of a national registry, or network of local registries, of families willing to adopt
p.000551: newborns with Down syndrome or other prenatally or postnatally diagnosed conditions, and links to adoption
p.000551: agencies willing to place babies with Down syndrome or other prenatally or postnatally diagnosed condi-
p.000551: tions, with families willing to adopt; and
p.000551: (v) the establishment of awareness and education programs for health care providers who provide, inter- pret, or
p.000551: inform parents of the results of prenatal tests for Down syndrome or other prenatally or postnatally diagnosed
p.000551: conditions, to patients, consistent with the purpose described in section 2(b)(1) 107 of the Pre-
p.000551: natally and Postnatally Diagnosed Conditions Aware- ness Act.
p.000551: (2) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ means—
p.000551: (A) a State or a political subdivision of a State;
p.000551: (B) a consortium of 2 or more States or political sub- divisions of States;
p.000551: (C) a territory;
p.000551: (D) a health facility or program operated by or pursu- ant to a contract with or grant from the Indian Health
p.000551: Service; or
p.000551: (E) any other entity with appropriate expertise in pre- natally and postnatally diagnosed conditions (including na-
p.000551: tionally recognized disability groups), as determined by the Secretary.
p.000551: (3) DISTRIBUTION.—In distributing funds under this sub- section, the Secretary shall place an emphasis on funding
p.000551: part- nerships between health care professional groups and dis- ability advocacy organizations.
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p.000551: January 30, 2020
p.000551: 107 So in law. Probably should read ‘‘section 2(1)’’.
p.000551: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
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p.000571: PUBLIC HEALTH SERVICE ACT
p.000571: Sec. 399Y
p.000571:
p.000571: (f) TERM.—A grant awarded under subsection (a) shall be for a term of 3 years.
p.000571: (g) DEFINITION.—In this section, the term ‘‘children and adoles- cents’’ means individuals who do not exceed 18 years
p.000571: of age.
p.000571: (h) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399X. ø280h–1¿ APPLIED RESEARCH PROGRAM.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Centers for Disease Control and Prevention and in
p.000571: consultation with the Director of the National Institutes of Health, shall—
p.000571: (1) conduct research to better understand the relationship between physical activity, diet, and health and
p.000571: factors that in- fluence health-related behaviors;
p.000571: (2) develop and evaluate strategies for the prevention and treatment of obesity to be used in community-based
p.000571: interven- tions and by health professionals;
p.000571: (3) develop and evaluate strategies for the prevention and treatment of eating disorders, such as anorexia and bulimia;
p.000571: (4) conduct research to establish the prevalence, con- sequences, and costs of childhood obesity
p.000571: and its effects in adulthood;
p.000571: (5) identify behaviors and risk factors that contribute to obesity;
p.000571: (6) evaluate materials and programs to provide nutrition education to parents and teachers of children in
p.000571: child care or pre-school and the food service staff of such child care and pre- school entities; and
p.000571: (7) evaluate materials and programs that are designed to educate and encourage physical activity in child
p.000571: care and pre- school facilities.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Y. ø280h–2¿ EDUCATION CAMPAIGN.
p.000571: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000571: and in collabora- tion with national, State, and local partners, physical activity orga- nizations, nutrition
p.000571: experts, and health professional organizations, shall develop a national public campaign to promote and
p.000571: educate children and their parents concerning—
p.000571: (1) the health risks associated with obesity, inactivity, and poor nutrition;
p.000571: (2) ways in which to incorporate physical activity into daily living; and
p.000571: (3) the benefits of good nutrition and strategies to improve eating habits.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571:
p.000571: January 30, 2020 As Amended Through P.L. 116-94,
p.000571: Enacted December 20, 2019
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p.000571: Sec. 399Z PUBLIC HEALTH SERVICE ACT 572
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p.000571: SEC. 399Z. ø280h–3¿ HEALTH PROFESSIONAL EDUCATION AND TRAIN- ING.
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p.000583: (A) the Director of the Centers for Disease Control and Prevention;
p.000583: (B) the Director of the National Institutes of Health, and the Directors of such national research
p.000583: institutes of the National Institutes of Health as the Secretary deter- mines appropriate;
p.000583: (C) the heads of such other agencies as the Secretary determines appropriate, such as the Administration
p.000583: for Community Living, Administration for Children and Fami- lies, the Centers for Medicare & Medicaid Services,
p.000583: the Food and Drug Administration, and the Health Resources and Services Administration; and
p.000583: (D) representatives of other Federal Governmental agencies that serve individuals with autism spectrum
p.000583: dis- order such as the Department of Education, the Depart- ment of Labor, the Department of Justice, the
p.000583: Department of Veterans Affairs, the Department of Housing and Urban Development, and the Department of Defense.
p.000583: (2) NON-FEDERAL MEMBERS.—Not more than 1⁄2, but not fewer than 1⁄3, of the total membership of the Committee,
p.000583: shall be composed of non-Federal public members to be appointed by the Secretary, of which—
p.000583: (A) at least three such members shall be individuals with a diagnosis of autism spectrum disorder;
p.000583: (B) at least three such members shall be parents or legal guardians of an individual with an autism
p.000583: spectrum disorder; and
p.000583: (C) at least three such members shall be representa- tives of leading research, advocacy, and service
p.000583: organiza- tions for individuals with autism spectrum disorder.
p.000583: (3) PERIOD OF APPOINTMENT; VACANCIES.—
p.000583: (A) PERIOD OF APPOINTMENT FOR NON-FEDERAL MEM- BERS.—Non-Federal members shall serve for a term of 4
p.000583: years, and may be reappointed for one additional 4-year term.
p.000583: (B) VACANCIES.—A vacancy on the Committee shall be filled in the manner in which the original appointment was
p.000583: made and shall not affect the powers or duties of the Committee. Any member appointed to fill a vacancy for an
p.000583: unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of
p.000583: the member’s term until a successor has been appointed.
p.000583: (d) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PRO- VISIONS.—The following provisions shall apply with
p.000583: respect to the Committee:
p.000583: (1) The Committee shall receive necessary and appropriate administrative support from the Secretary.
p.000583: (2) The Committee shall meet at the call of the chairperson or upon the request of the Secretary. The Committee
p.000583: shall meet not fewer than 2 times each year.
p.000583: (3) All meetings of the Committee shall be public and shall include appropriate time periods for questions and
p.000583: presen- tations by the public.
p.000583: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000591: safety organizations working with those hospitals shall report to the Secretary on the processes employed
p.000591: by the hospital to improve readmission rates and the impact of such processes on readmission rates.
p.000591:
p.000591: PART T—ORAL HEALTHCARE PREVENTION ACTIVITIES
p.000591:
p.000591: SEC. 399LL. ø280k¿ ORAL HEALTHCARE PREVENTION EDUCATION CAMPAIGN.
p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: January 30, 2020
p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
p.000591: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000593: PUBLIC HEALTH SERVICE ACT
p.000593: Sec. 399LL–1
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p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
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p.000641: Sec. 404E PUBLIC HEALTH SERVICE ACT 642
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p.000641: and Prevention, the Health Resources and Services Admin- istration, the Food and Drug Administration, and the
p.000641: Ad- ministration for Community Living and representatives of other governmental agencies that serve
p.000641: children and adults with muscular dystrophy, including the Department of Education and the Social Security
p.000641: Administration; and
p.000641: (B) 1⁄3 of such members shall be public members, in- cluding a broad cross section of persons affected with
p.000641: mus- cular dystrophies including parents or legal guardians, af- fected individuals, researchers, and clinicians.
p.000641: Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an
p.000641: unlimited number of terms if reappointed.
p.000641: (3) CHAIR.—
p.000641: (A) IN GENERAL.—With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the
p.000641: principal advisor to the Secretary, the Assistant Sec- retary for Health, and the Director of NIH, and shall
p.000641: pro- vide advice to the Director of the Centers for Disease Con- trol and Prevention, the Commissioner of Food and
p.000641: Drugs, and to the heads of other relevant agencies. The Coordi- nating Committee shall select the Chair
p.000641: for a term not to exceed 2 years.
p.000641: (B) APPOINTMENT.—The Chair of the Committee shall be appointed by and be directly responsible to the
p.000641: Sec- retary.
p.000641: (4) ADMINISTRATIVE SUPPORT; TERMS OF SERVICE; OTHER PROVISIONS.—The following shall apply with respect to the
p.000641: Co- ordinating Committee:
p.000641: (A) The Coordinating Committee shall receive nec- essary and appropriate administrative support from the
p.000641: Department of Health and Human Services.
p.000641: (B) The Coordinating Committee shall meet as appro- priate as determined by the Secretary, in consultation with
p.000641: the chair, but shall meet no fewer than two times per cal- endar year.
p.000641: (e) PLAN FOR HHS ACTIVITIES.—
p.000641: (1) IN GENERAL.—Not later than 1 year after the date of enactment of this section, the Coordinating
p.000641: Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy
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p.000719: (4) The development of improved diagnostic techniques.
p.000719: (5) Clinical research for the development and evaluation of new treatments, including new biological agents.
p.000719: (6) Information and education programs for health care professionals and the public.
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p.000719: January 30, 2020
p.000719: ADVISORY BOARD
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p.000719: SEC. 442. ø285d–7¿ (a) The Secretary shall establish in the In- stitute the National Arthritis and Musculoskeletal
p.000719: and Skin Dis- eases Advisory Board (hereafter in this section referred to as the ‘‘Advisory Board’’).
p.000719: (b) The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
p.000719: (1) The Secretary shall appoint—
p.000719: (A) twelve members from individuals who are sci- entists, physicians, and other health professionals, who are
p.000719: not officers or employees of the United States, and who represent the specialties and disciplines relevant to
p.000719: arthri- tis, musculoskeletal diseases, and skin diseases; and
p.000719: (B) eight members from the general public who are knowledgeable with respect to such diseases, including one
p.000719: member who is a person who has such a disease, one per- son who is the parent of an adult with such a disease, and two
p.000719: members who are parents of children with arthritis.
p.000719: Of the appointed members at least five shall by virtue of train- ing or experience be knowledgeable in health
p.000719: education, nurs- ing, data systems, public information, or community program development.
p.000719: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000721: PUBLIC HEALTH SERVICE ACT
p.000721: Sec. 442
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p.000721: (2) The following shall be ex officio members of the Advi- sory Board:
p.000721: (A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and
p.000721: Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the
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p.000849: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000849: Sec. 508 PUBLIC HEALTH SERVICE ACT 850
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p.000849:
p.000849: (5) Training in parenting.
p.000849: (6) Counseling on the human immunodeficiency virus and on acquired immune deficiency syndrome.
p.000849: (7) Counseling on domestic violence and sexual abuse.
p.000849: (8) Counseling on obtaining employment, including the im- portance of graduating from a secondary school.
p.000849: (9) Reasonable efforts to preserve and support the family unit of the woman, including promoting the
p.000849: appropriate in- volvement of parents and others, and counseling the children of the woman.
p.000849: (10) Planning for and counseling to assist reentry into soci- ety, both before and after discharge, including referrals
p.000849: to any public or nonprofit private entities in the community involved that provide services appropriate for
p.000849: the woman and the chil- dren of the woman.
p.000849: (11) Case management services, including—
p.000849: (A) assessing the extent to which authorized services are appropriate for the woman and any child of
p.000849: such woman;
p.000849: (B) in the case of the services that are appropriate, en- suring that the services are provided in a
p.000849: coordinated manner;
p.000849: (C) assistance in establishing eligibility for assistance under Federal, State, and local programs providing
p.000849: health services, mental health services, housing services, employ- ment services, educational services, or social
p.000849: services; and
p.000849: (D) family reunification with children in kinship or foster care arrangements, where safe and appropriate.
p.000849: (e) MINIMUM QUALIFICATIONS FOR RECEIPT OF AWARD.—
p.000849: (1) CERTIFICATION BY RELEVANT STATE AGENCY.—With re- spect to the principal agency of the State involved that
p.000849: admin- isters programs relating to substance use disorders, the Direc- tor may make an award under subsection
p.000849: (a) to an applicant only if the agency has certified to the Director that—
...

p.000865: illegal furnishing or obtaining of al- cohol for an individual under 21 years; the degree of strictness of the
p.000865: penalties for such offenses; and the prevalence of the enforcement of each of these infractions.
p.000865: (II) Whether or not the State has comprehen- sive liability statutes pertaining to underage ac- cess to alcohol
p.000865: such as dram shop, social host, and house party laws, and the prevalence of enforce- ment of each of these laws.
p.000865: (III) Whether or not the State encourages and conducts comprehensive enforcement efforts to prevent underage
p.000865: access to alcohol at retail out- lets, such as random compliance checks and shoul- der tap programs, and the
p.000865: number of compliance checks within alcohol retail outlets measured against the number of total alcohol
p.000865: retail outlets in each State, and the result of such checks.
p.000865: (IV) Whether or not the State encourages training on the proper selling and serving of alco- hol for all
p.000865: sellers and servers of alcohol as a condi- tion of employment.
p.000865: (V) Whether or not the State has policies and regulations with regard to direct sales to con- sumers and home
p.000865: delivery of alcoholic beverages.
p.000865: (VI) Whether or not the State has programs or laws to deter adults from purchasing alcohol for minors; and the
p.000865: number of adults targeted by these programs.
p.000865: (VII) Whether or not the State has programs targeted to youths, parents, and caregivers to
p.000865: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000865:
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p.000865:
p.000867: 867
p.000867: PUBLIC HEALTH SERVICE ACT
p.000867: Sec. 519B
p.000867:
p.000867: deter underage drinking; and the number of indi- viduals served by these programs.
p.000867: (VIII) Whether or not the State has enacted graduated drivers licenses and the extent of those provisions.
p.000867: (IX) The amount that the State invests, per youth capita, on the prevention of underage drink- ing, further
p.000867: broken down by the amount spent on—
p.000867: (aa) compliance check programs in retail outlets, including providing technology to pre- vent and detect the
p.000867: use of false identification by minors to make alcohol purchases;
p.000867: (bb) checkpoints and saturation patrols that include the goal of reducing and deter- ring underage drinking;
p.000867: (cc) community-based, school-based, and higher-education-based programs to prevent underage drinking;
p.000867: (dd) underage drinking prevention pro- grams that target youth within the juvenile justice and child
p.000867: welfare systems; and
p.000867: (ee) other State efforts or programs as deemed appropriate.
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p.000871: and attitudes about alcohol use during pre- and early adolescence, including harm caused to self or others as a
p.000871: result of adolescent alcohol use such as violence, date rape, risky sexual behavior, and prenatal alcohol
p.000871: exposure.
p.000871: (ii) Developing or identifying successful clinical treatments for youth with alcohol problems.
p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
p.000871: paragraph (2) by—
p.000871: (A) providing training to health care providers;
p.000871: (B) disseminating best practices, including culturally and linguistically appropriate best practices, as
p.000871: appro- priate, and developing and distributing materials; and
p.000871: (C) supporting other activities, as determined appro- priate by the Assistant Secretary.
p.000871: (4) APPLICATION.—To be eligible to receive a grant under this subsection, an entity shall submit an
p.000871: application to the Assistant Secretary at such time, and in such manner, and ac- companied by such information as the
p.000871: Assistant Secretary may require. Each application shall include—
p.000871: (A) a description of the entity;
p.000871: (B) a description of activities to be completed;
p.000871:
p.000871:
p.000871:
p.000871:
p.000871: January 30, 2020
p.000871: 8 Missing period so in law. Section 9016(4) of Public Law 114-255 amends subsection (f)(2) by striking ‘‘$6,000,000 for
p.000871: fiscal year 2007’’ and all that follows through the period at the end and inserting ‘‘$3,000,000 for each of the fiscal
p.000871: years 2018 through 2022’’.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000879: prevention practices and strategies adapted to the local community;
p.000879: (4) provide timely referrals for appropriate community- based mental health care and treatment of youth
p.000879: who are at risk for suicide in child-serving settings and agencies;
p.000879: (5) provide immediate support and information resources to families of youth who are at risk for suicide;
p.000879: (6) offer access to services and care to youth with diverse linguistic and cultural backgrounds;
p.000879: (7) offer appropriate postsuicide intervention services, care, and information to families, friends, schools,
p.000879: educational insti- tutions, juvenile justice systems, substance use disorder pro- grams, mental health programs,
p.000879: foster care systems, and other child and youth support organizations of youth who recently completed suicide;
p.000879: (8) offer continuous and up-to-date information and aware- ness campaigns that target parents, family members,
p.000879: child care professionals, community care providers, and the general public and highlight the risk factors
p.000879: associated with youth sui- cide and the life-saving help and care available from early intervention and
p.000879: prevention services;
p.000879: (9) ensure that information and awareness campaigns on youth suicide risk factors, and early intervention
p.000879: and preven- tion services, use effective communication mechanisms that are targeted to and reach youth, families,
p.000879: schools, educational in- stitutions, and youth organizations;
p.000879: (10) provide a timely response system to ensure that child- serving professionals and providers are properly
p.000879: trained in youth suicide early intervention and prevention strategies and
p.000879: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: PUBLIC HEALTH SERVICE ACT
p.000881: Sec. 520E
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p.000881:
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p.000881: January 30, 2020
p.000881: (G) third-party payers, managed care organizations, and related commercial industries.
p.000881: (3) POLICY DEVELOPMENT.—In carrying out this section, the Secretary shall—
p.000881: (A) coordinate and collaborate on policy development at the Federal level with the relevant
p.000881: Department of
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000881: Sec. 520E PUBLIC HEALTH SERVICE ACT 882
p.000881:
p.000881: Health and Human Services agencies and suicide working groups; and
p.000881: (B) consult on policy development at the Federal level with the private sector, including consumer, medical,
p.000881: sui- cide prevention advocacy groups, and other health and education professional-based organizations, with
p.000881: respect to State-sponsored statewide or tribal youth suicide early intervention and prevention strategies.
p.000881: (f) RULE OF CONSTRUCTION; RELIGIOUS AND MORAL ACCOMMO- DATION.—Nothing in this section shall be construed to
p.000881: require sui- cide assessment, early intervention, or treatment services for youth whose parents or legal guardians
p.000881: object based on the parents’ or legal guardians’ religious beliefs or moral objections.
p.000881: (g) EVALUATIONS AND REPORT.—
p.000881: (1) EVALUATIONS BY ELIGIBLE ENTITIES.—Not later than 18 months after receiving a grant or cooperative agreement
p.000881: under this section, an eligible entity shall submit to the Secretary the results of an evaluation to be conducted
p.000881: by the entity con- cerning the effectiveness of the activities carried out under the grant or agreement.
p.000881: (2) REPORT.—Not later than 2 years after the date of en- actment of Helping Families in Mental Health
p.000881: Crisis Reform Act of 2016, the Secretary shall submit to the appropriate com- mittees of Congress a report concerning
p.000881: the results of—
p.000881: (A) the evaluations conducted under paragraph (1);
p.000881: and
p.000881: (B) an evaluation conducted by the Secretary to ana-
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p.000881: January 30, 2020
p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
...

p.000937: ation of systems of care described in section 562.
p.000937: (2) AUTHORITY FOR GRANTS AND CONTRACTS.—The Sec- retary may provide technical assistance under
p.000937: subsection (a) directly or through grants to, or contracts with, public and non- profit private entities.
p.000937: (c) EVALUATIONS AND REPORTS BY SECRETARY.—
p.000937: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities,
p.000937: provide for annual evaluations of programs carried out pursuant to section 561(a). The evaluations shall assess the
p.000937: effectiveness of the systems of care operated pursuant to such section, including longitudinal studies of
p.000937: outcomes of services provided by such systems, other
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
p.000937:
p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
p.000937: first appro- priated under subsection (c), and annually thereafter, submit to the Congress a report
p.000937: summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year and making such
p.000937: recommendations for administrative and legisla- tive initiatives with respect to this section as the Secretary de-
p.000937: termines to be appropriate.
p.000937: (d) DEFINITIONS.—For purposes of this part:
p.000937: (1) The term ‘‘child’’ means an individual through the age of 21 years.
p.000937: (2) The term ‘‘family’’, with respect to a child provided ac- cess to a system of care under section 562(a), means—
p.000937: (A) the legal guardian of the child; and
p.000937: (B) as appropriate regarding mental health services for the child, the parents of the child (biological
p.000937: or adop- tive, as the case may be) and any foster parents of the child.
p.000937: (3) The term ‘‘funding agreement’’, with respect to a grant under section 561(a) to a public entity, means that
p.000937: the Sec- retary may make such a grant only if the public entity makes the agreement involved.
p.000937: (4) The term ‘‘serious emotional disturbance’’ includes, with respect to a child, any child who has a
p.000937: serious emotional disorder, a serious behavioral disorder, or a serious mental dis- order.
p.000937: (e) RULE OF CONSTRUCTION.—Nothing in this part shall be con- strued as limiting the rights of a child with a serious
p.000937: emotional dis- turbance under the Individuals with Disabilities Education Act.
p.000937: (f) FUNDING.—
p.000937: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this part, there are authorized to
p.000937: be appro- priated $119,026,000 for each of fiscal years 2018 through 2022.
p.000937: (2) 17 LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more than 10 percent of the amounts
p.000937: appropriated under para- graph (1) for a fiscal year may be expended for carrying out sub- section (b).
p.000937:
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p.000937: January 30, 2020
p.000937:
p.000937: 17 Indentation is so in law. See section 2017(2)(C)(ii) of Public Law 103–43 (107 Stat. 218).
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
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p.001167: (a) AUTHORIZATION OF GRANT PROGRAM.—From amounts ap- propriated under section 1117, the Secretary,
p.001167: acting through the Administrator of the Health Resources and Services Administration (referred to in this section as
p.001167: the ‘‘Administrator’’) and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in
p.001167: Newborns and Children (referred to in this section as the ‘‘Advisory Committee’’), shall award grants to
p.001167: eligible entities to enable such entities—
p.001167: (1) to enhance, improve or expand the ability of State and local public health agencies to provide screening,
p.001167: counseling, or health care services to newborns and children having or at risk for heritable disorders;
p.001167: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education
p.001167: in new- born screening, counseling, and training in—
p.001167: (A) relevant and new technologies in newborn screen- ing and congenital, genetic, and metabolic disorders;
p.001167: (B) the importance of the timeliness of collection, de- livery, receipt, and screening of specimens; and
p.001167: (C) sharing of medical and diagnostic information with providers and families;
p.001167: (3) to develop and deliver educational programs (at appro- priate literacy levels) about newborn screening
p.001167: counseling, testing, follow-up, treatment, and specialty services to parents, families, and patient advocacy and
p.001167: support groups;
p.001167: (4) to establish, maintain, and operate a system to assess and coordinate followup and treatment relating
p.001167: to congenital, genetic, and metabolic disorders; and
p.001167: (5) to improve the timeliness of—
p.001167: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001169: 1169
p.001169: PUBLIC HEALTH SERVICE ACT
p.001169: Sec. 1109
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p.001169: (A) the collection, delivery, receipt, and screening of specimens; and
p.001169: (B) the diagnosis of heritable disorders in newborns.
p.001169: (b) ELIGIBLE ENTITY.—In this section, the term ‘‘eligible entity’’ means—
p.001169: (1) a State or a political subdivision of a State;
p.001169: (2) a consortium of 2 or more States or political subdivi- sions of States;
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p.001173: Sec. 1112 PUBLIC HEALTH SERVICE ACT 1174
p.001173:
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p.001173: January 30, 2020
p.001173:
p.001173: SEC. 1112. ø300b–11¿ CLEARINGHOUSE OF NEWBORN SCREENING IN- FORMATION.
p.001173: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.001173: Administration (re- ferred to in this part as the ‘‘Administrator’’), in consultation with the Director of the Centers
p.001173: for Disease Control and Prevention and the Director of the National Institutes of Health, shall establish and
p.001173: maintain a central clearinghouse of current educational and family support and services information,
p.001173: materials, resources, re- search, and data on newborn screening to—
p.001173: (1) enable parents and family members of newborns, health professionals, industry representatives, and
p.001173: other mem- bers of the public to increase their awareness, knowledge, and understanding of newborn screening;
p.001173: (2) increase awareness, knowledge, and understanding of newborn diseases and screening services for expectant
p.001173: individ- uals and families;
p.001173: (3) maintain current information on quality indicators to measure performance of newborn screening, such as
p.001173: false-posi- tive rates and other quality indicators as determined by the Advisory Committee under section
p.001173: 1111;
p.001173: (4) maintain current information on the number of condi- tions for which screening is conducted in each State;
p.001173: and
p.001173: (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect
p.001173: to condi- tions detected by newborn screening.
p.001173: (b) INTERNET AVAILABILITY.—The Secretary, acting through the Administrator, shall ensure that the clearinghouse
p.001173: described under subsection (a)—
p.001173: (1) is available on the Internet;
p.001173: (2) includes an interactive forum;
p.001173: (3) is updated on a regular basis, but not less than quar- terly; and
p.001173: (4) provides—
p.001173: (A) links to Government-sponsored, non-profit, and other Internet websites of laboratories that have
p.001173: dem- onstrated expertise in newborn screening that supply re- search-based information on newborn screening
p.001173: tests cur- rently available throughout the United States;
p.001173: (B) information about newborn conditions and screen- ing services available in each State from
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p.001301: (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of
p.001301: mental health serv- ices within the State.
p.001301: (c) MEMBERSHIP.—
p.001301: (1) IN GENERAL.—A condition under subsection (a) for a Council is that the Council be composed of
p.001301: residents of the State, including representatives of—
p.001301: (A) the principal State agencies with respect to—
p.001301: (i) mental health, education, vocational rehabilita- tion, criminal justice, housing, and social services; and
p.001301: (ii) the development of the plan submitted pursu- ant to title XIX of the Social Security Act;
p.001301: (B) public and private entities concerned with the need, planning, operation, funding, and use of
p.001301: mental health services and related support services;
p.001301: (C) adults with serious mental illnesses who are re- ceiving (or have received) mental health services; and
p.001301: (D) the families of such adults or families of children with emotional disturbance.
p.001301: (2) CERTAIN REQUIREMENTS.—A condition under subsection
p.001301: (a) for a Council is that—
p.001301: (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional
p.001301: dis- turbance to other members of the Council is sufficient to
p.001301: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001301: Sec. 1915 PUBLIC HEALTH SERVICE ACT 1302
p.001301:
p.001301: provide adequate representation of such children in the de- liberations of the Council; and
p.001301: (B) not less than 50 percent of the members of the Council are individuals who are not State employees
p.001301: or providers of mental health services.
p.001301: (d) DEFINITION.—For purposes of this section, the term ‘‘Coun- cil’’ means a State mental health planning council.
p.001301: SEC. 1915. ø300x–4¿ ADDITIONAL PROVISIONS.
p.001301: (a) REVIEW OF STATE PLAN BY MENTAL HEALTH PLANNING COUNCIL.—The Secretary may make a grant under section
p.001301: 1911 to a State only if—
p.001301: (1) the plan submitted under section 1912(a) with respect to the grant and the report of the State under
p.001301: section 1942(a) concerning the preceding fiscal year has been reviewed by the State mental health planning
p.001301: council under section 1914; and
p.001301: (2) the State submits to the Secretary any recommenda- tions received by the State from such council for
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p.001341: to teenagers;
p.001341: (3) in a high proportion of cases, the pregnant adolescent is herself the product of an unmarried parenthood
p.001341: during ado- lescence and is continuing the pattern in her own lifestyle;
p.001341: (4) it is estimated that approximately 80 per centum of un- married teenagers who carry their pregnancies to
p.001341: term live with their families before and during their pregnancy and re- main with their families after the
p.001341: birth of the child;
p.001341: (5) pregnancy and childbirth among unmarried adoles- cents, particularly young adolescents, often results
p.001341: in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth
p.001341: complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a
p.001341: greater likelihood that an adoles- cent marriage will end in divorce; a decreased likelihood of completing
p.001341: schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job
p.001341: research services are important for adolescent parents;
p.001341: (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for
p.001341: their chil- dren since adoption is a means of providing permanent families for such children from available approved
p.001341: couples who are un- able or have difficulty in conceiving or carrying children of their own to term; and
p.001341: (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into
p.001341: an adop- tion plan or arrange for their babies to be cared for by relatives or friends;
p.001341: (7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and
p.001341: childbearing, with increased risks;
p.001341: (8)(A) the problems of adolescent premarital sexual rela- tions, pregnancy, and parenthood are multiple
p.001341: and complex
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001341: Sec. 2001 PUBLIC HEALTH SERVICE ACT 1342
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p.001341: associations, and other groups in the private sector as well as services provided by publicly spon- sored initiatives;
p.001341: (9) a wide array of educational, health, and supportive services are not available to adolescents with such
p.001341: problems or to their families, or when available frequently are fragmented and thus are of limited
p.001341: effectiveness in discouraging adolescent premarital sexual relations and the consequences of such rela- tions;
p.001341: (10)(A) prevention of adolescent sexual activity and adoles- cent pregnancy depends primarily upon developing strong
p.001341: fam- ily values and close family ties, and since the family is the basic social unit in which the
p.001341: values and attitudes of adoles- cents concerning sexuality and pregnancy are formed, pro- grams designed to
p.001341: deal with issues of sexuality and pregnancy will be successful to the extent that such programs encourage and
p.001341: sustain the role of the family in dealing with adolescent sexual activity and adolescent pregnancy;
p.001341: (B) Federal policy therefore should encourage the develop- ment of appropriate health, educational, and social
p.001341: services where such services are now lacking or inadequate, and the better coordination of existing
p.001341: services where they are avail- able; and
p.001341: (C) services encouraged by the Federal Government should promote the involvement of parents with their adolescent chil-
p.001341: dren, and should emphasize the provision of support by other family members, religious and charitable
p.001341: organizations, vol- untary associations, and other groups in the private sector in order to help adolescents
p.001341: and their families deal with complex issues of adolescent premarital sexual relations and the con- sequences of
p.001341: such relations; and
p.001341: (11)(A) there has been limited research concerning the so- cietal causes and consequences of adolescent pregnancy;
p.001341: (B) there is limited knowledge concerning which means of intervention are effective in mediating or
p.001341: eliminating adoles- cent premarital sexual relations and adolescent pregnancy; and
p.001341: (C) it is necessary to expand and strengthen such knowl- edge in order to develop an array of approaches to
p.001341: solving the problems of adolescent premarital sexual relations and adoles- cent pregnancy in both urban and rural
p.001341: settings.
p.001341: (b) Therefore, the purposes of this title are—
p.001341: (1) to find effective means, within the context of the fam- ily, of reaching adolescents before they
p.001341: become sexually active in order to maximize the guidance and support available to adolescents from parents
p.001341: and other family members, and to promote self discipline and other prudent approaches to the problem of
p.001341: adolescent premarital sexual relations, including adolescent pregnancy;
p.001341: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001343: 1343
p.001343: PUBLIC HEALTH SERVICE ACT
p.001343: Sec. 2002
p.001343:
p.001343: (2) to promote adoption as an alternative for adolescent parents;
p.001343: (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services
p.001343: both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of
p.001343: age or under, and for adolescent parents, which shall be based upon an assessment of existing programs
p.001343: and, where appropriate, upon efforts to establish bet- ter coordination, integration, and linkages among such existing
p.001343: programs in order to—
p.001343: (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to
p.001343: become productive independent contributors to family and community life; and
p.001343: (B) assist families of adolescents to understand and re- solve the societal causes which are associated with adoles-
p.001343: cent pregnancy;
p.001343: (4) to encourage and support research projects and dem- onstration projects concerning the societal causes
p.001343: and con- sequences of adolescent premarital sexual relations, contracep- tive use, pregnancy, and child rearing;
p.001343: (5) to support evaluative research to identify effective serv- ices which alleviate, eliminate, or resolve any
p.001343: negative con- sequences of adolescent premarital sexual relations and adoles- cent childbearing for the parents, the
p.001343: child, and their families; and
p.001343: (6) to encourage and provide for the dissemination of re- sults, findings, and information from programs
p.001343: and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood.
p.001343: DEFINITIONS
p.001343: SEC. 2002. ø300z–1¿ (a) For the purposes of this title, the term—
p.001343:
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p.001343: January 30, 2020
p.001343: (1) ‘‘Secretary’’ means the Secretary of Health and Human Services;
p.001343: (2) ‘‘eligible person’’ means—
p.001343: (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family
p.001343: of a pregnant adolescent or an adolescent parent; or
p.001343: (B) with regard to the provision of prevention services and referral to such other services which may be
p.001343: appro- priate, a nonpregnant adolescent;
p.001343: (3) ‘‘eligible grant recipient’’ means a public or nonprofit private organization or agency which demonstrates,
p.001343: to the sat- isfaction of the Secretary—
p.001343: (A) in the case of an organization which will provide care services, the capability of providing all
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p.001343: January 30, 2020
p.001343:
p.001343: (4) ‘‘necessary services’’ means services which may be pro- vided by grantees which are—
p.001343: (A) pregnancy testing and maternity counseling;
p.001343: (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, in-
p.001343: cluding referral to licensed adoption agencies in the com- munity if the eligible grant recipient is not
p.001343: a licensed adoption agency;
p.001343: (C) primary and preventive health services including prenatal and postnatal care;
p.001343: (D) nutrition information and counseling;
p.001343: (E) referral for screening and treatment of venereal disease;
p.001343: (F) referral to appropriate pediatric care;
p.001343: (G) educational services relating to family life and problems associated with adolescent premarital sexual
p.001343: re- lations, including—
p.001343: (i) information about adoption;
p.001343: (ii) education on the responsibilities of sexuality and parenting;
p.001343: (iii) the development of material to support the role of parents as the provider of sex education; and
p.001343: (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and pre-
p.001343: adolescents concerning self-discipline and responsi- bility in human sexuality;
p.001343: (H) appropriate educational and vocational services;
p.001343: (I) referral to licensed residential care or maternity home services; and
p.001343: (J) mental health services and referral to mental health services and to other appropriate physical
p.001343: health services;
p.001343: (K) child care sufficient to enable the adolescent par- ent to continue education or to enter into employment;
p.001343: (L) consumer education and homemaking;
p.001343: (M) counseling for the immediate and extended family members of the eligible person;
p.001343: (N) transportation;
p.001343: (O) outreach services to families of adolescents to dis- courage sexual relations among unemancipated minors;
p.001343: (P) family planning services; and
p.001343: (Q) such other services consistent with the purposes of this title as the Secretary may approve in accordance with
p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
p.001345: prevention services in easily accessible locations. Dem- onstration projects shall, as appropriate,
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p.001345: Sec. 2005 PUBLIC HEALTH SERVICE ACT 1346
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p.001345: (C) care and prevention services (in the case of a grantee who is providing a combination of care and
p.001345: pre- vention services);
p.001345: (2) coordinate, integrate, and provide linkages among pro- viders of care, prevention, and other services
p.001345: for eligible per- sons in furtherance of the purposes of this title;
p.001345: (3) provide supplemental services where such services are not adequate or not available to eligible persons in
p.001345: the commu- nity and which are essential to the care of pregnant adoles- cents and to the prevention of
p.001345: adolescent premarital sexual re- lations and adolescent pregnancy;
p.001345: (4) plan for the administration and coordination of preg- nancy prevention services and programs of care
p.001345: for pregnant adolescents and adolescent parents which will further the ob- jectives of this title; and
p.001345: (5) fulfill assurances required for grant approval by section 2006.
p.001345: (b)(1) No funds provided for a demonstration project for serv- ices under this title may be used for
p.001345: the provision of family plan- ning services (other than counseling and referral services) to ado- lescents
p.001345: unless appropriate family planning services are not other- wise available in the community.
p.001345: (2) Any grantee who receives funds for a demonstration project for services under this title and who, after determining
p.001345: under para- graph (1) that appropriate family planning services are not other- wise available in the
p.001345: community, provides family planning services (other than counseling and referral services) to adolescents may
p.001345: only use funds provided under this title for such family planning services if all funds received by such
p.001345: grantee from all other sources to support such family planning services are insufficient to support such family
p.001345: planning services.
p.001345: (c) Grantees who receive funds for a demonstration project for services under this title shall charge fees for
p.001345: services pursuant to a fee schedule approved by the Secretary as a part of the applica- tion described
p.001345: in section 2006 which bases fees charged by the grantee on the income of the eligible person or the parents or
p.001345: legal guardians of the eligible person and takes into account the dif- ficulty adolescents face in
p.001345: obtaining resources to pay for services. A grantee who receives funds for a demonstration project for serv- ices
p.001345: under this title may not, in any case, discriminate with regard to the provision of services to any individual
p.001345: because of that indi- vidual’s inability to provide payment for such services, except that in determining the
p.001345: ability of an unemancipated minor to provide payment for services, the income of the family of an unemancipated
p.001345: minor shall be considered in determining the ability of such minor to make such payments unless the parents or
p.001345: guardians of the unemancipated minor refuse to make such payments.
p.001345: PRIORITIES, AMOUNTS, AND DURATION OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2005. ø300z–4¿ (a) In approving applications for grants for demonstration projects for services under
p.001345: this title, the Sec- retary shall give priority to applicants who—
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: 1347
p.001347: PUBLIC HEALTH SERVICE ACT
p.001347: Sec. 2005
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p.001347: January 30, 2020
p.001347: (1) serve an area where there is a high incidence of adoles- cent pregnancy;
p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
p.001347: pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth cen- ters,
p.001347: maternal and infant health centers, regional rural health facilities, school and other educational programs,
p.001347: mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services
p.001347: and programs of care for pregnant adolescents and adolescent parents;
p.001347: (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs,
p.001347: contributions, and other third-party reimbursements;
p.001347: (6) can demonstrate a community commitment to the pro- gram by making available to the demonstration
p.001347: project non- Federal funds, personnel, and facilities;
p.001347: (7) have involved the community to be served, including public and private agencies, adolescents, and
p.001347: families, in the planning and implementation of the demonstration project; and
p.001347: (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital
p.001347: sexual rela- tions, pregnancy, or parenthood, including approaches to pro- vide pregnant adolescents with
p.001347: adequate information about adoption.
p.001347: (b)(1) The amount of a grant for a demonstration project for services under this title shall be
p.001347: determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the
p.001347: geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for
p.001347: pregnant adolescents and adolescent parents in such area.
p.001347: (2) In making grants for demonstration projects for services under this title, the Secretary shall
p.001347: consider the special needs of
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: Sec. 2006 PUBLIC HEALTH SERVICE ACT 1348
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p.001347: rural areas and, to the maximum extent practicable, shall dis- tribute funds taking into consideration the
p.001347: relative number of ado- lescents in such areas in need of such services.
p.001347: (c)(1) A grantee may not receive funds for a demonstration project for services under this title for a period
p.001347: in excess of 5 years. (2)(A) Subject to paragraph (3), a grant for a demonstration
p.001347: project for services under this title may not exceed—
p.001347: (i) 70 per centum of the costs of the project for the first and second years of the project;
p.001347: (ii) 60 per centum of such costs for the third year of the project;
p.001347: (iii) 50 per centum of such costs for the fourth year of the project; and
p.001347: (iv) 40 per centum of such costs for the fifth year of the project.
p.001347: (B) Non-Federal contributions required by subparagraph (A) may be in cash or in kind, fairly evaluated, including
p.001347: plant, equip- ment, or services.
p.001347: (3) The Secretary may waive the limitation specified in para- graph (2)(A) for any year in accordance with
p.001347: criteria established by regulation.
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p.001347: REQUIREMENTS FOR APPLICATIONS
p.001347: SEC. 2006. ø300z–5¿ (a) An application for a grant for a dem- onstration project for services under this
p.001347: title shall be in such form and contain such information as the Secretary may require, and shall include—
p.001347: (1) an identification of the incidence of adolescent preg- nancy and related problems;
p.001347: (2) a description of the economic conditions and income levels in the geographic area to be served;
p.001347: (3) a description of existing pregnancy prevention services and programs of care for pregnant adolescents
p.001347: and adolescent parents (including adoption services), and including where, how, by whom, and to which
p.001347: population groups such services are provided, and the extent to which they are coordinated in the
p.001347: geographic area to be served;
p.001347: (4) a description of the major unmet needs for services for adolescents at risk of initial or recurrent
p.001347: pregnancies and an estimate of the number of adolescents not being served in the area;
p.001347: (5)(A) in the case of an applicant who will provide care services, a description of how all core services
p.001347: will be provided in the demonstration project using funds under this title or will otherwise be provided
p.001347: by the grantee in the area to be served, the population to which such services will be provided, how such
p.001347: services will be coordinated, integrated, and linked with other related programs and services and the
p.001347: source or sources of funding of such core services in the public and pri- vate sectors; or
p.001347: (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be
p.001347: provided and how the applicant will provide such services;
p.001347: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001349: 1349
p.001349: PUBLIC HEALTH SERVICE ACT
p.001349: Sec. 2006
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p.001349: (6) a description of the manner in which adolescents need- ing services other than the services provided directly by
p.001349: the ap- plicant will be identified and how access and appropriate refer- ral to such other services (such as medicaid;
p.001349: licensed adoption agencies; maternity home services; public assistance; employ- ment services; child care
p.001349: services for adolescent parents; and other city, county, and State programs related to adolescent
p.001349: pregnancy) will be provided, including a description of a plan to coordinate such other services with
p.001349: the services supported under this title;
p.001349: (7) a description of the applicant’s capacity to continue services as Federal funds decrease and in the
p.001349: absence of Fed- eral assistance;
p.001349: (8) a description of the results expected from the provision of services, and the procedures to be used for evaluating
p.001349: those results;
p.001349: (9) a summary of the views of public agencies, providers of services, and the general public in the geographic
p.001349: area to be served, concerning the proposed use of funds provided for a demonstration project for services
p.001349: under this title and a de- scription of procedures used to obtain those views, and, in the case of applicants who
p.001349: propose to coordinate services adminis- tered by a State, the written comments of the appropriate State
p.001349: officials responsible for such services;
p.001349: (10) assurances that the applicant will have an ongoing quality assurance program;
p.001349: (11) assurances that, where appropriate, the applicant shall have a system for maintaining the
p.001349: confidentiality of pa- tient records in accordance with regulations promulgated by the Secretary;
p.001349: (12) assurances that the applicant will demonstrate its fi- nancial responsibility by the use of such
p.001349: accounting procedures and other requirements as may be prescribed by the Secretary;
p.001349: (13) assurances that the applicant (A) has or will have a contractual or other arrangement with the agency of
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p.001349: nished by the applicant;
p.001349: (19) assurances that fees collected by the applicant for services rendered in accordance with this title shall
p.001349: be used by the applicant to further the purposes of this title;
p.001349: (20) assurances that the applicant, if providing both pre- vention and care services will not exclude or
p.001349: discriminate against any adolescent who receives prevention services and subsequently requires care services
p.001349: as a pregnant adolescent;
p.001349: (21) a description of how the applicant will, as appropriate in the provision of services—
p.001349: (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of
p.001349: prob- lems relating to the parenthood or pregnancy of the adoles- cent;
p.001349: (B) involve religious and charitable organizations, vol- untary associations, and other groups in the private sector as
p.001349: well as services provided by publicly sponsored initia- tives;
p.001349: (22)(A) assurances that—
p.001349: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: 1351
p.001351: PUBLIC HEALTH SERVICE ACT
p.001351: Sec. 2006
p.001351:
p.001351: (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents
p.001351: or guardians of any unemancipated minor requesting services from the applicant and, except as provided in
p.001351: subpara- graph (C), will obtain the permission of such parents or guardians with respect to the provision
p.001351: of such services; and
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p.001351: (ii) in the case of a pregnant unemancipated minor re- questing services from the applicant, the applicant will no-
p.001351: tify the parents or guardians of such minor under clause
p.001351: (i) within a reasonable period of time;
p.001351: (B) assurances that the applicant will not notify or request the permission of the parents or
p.001351: guardian of any unemancipated minor without the consent of the minor—
p.001351: (i) who solely is requesting from the applicant preg- nancy testing or testing or treatment for venereal
p.001351: disease;
p.001351: (ii) who is the victim of incest involving a parent; or
p.001351: (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor
p.001351: by blood certifies to the grantee that notification of the parents or guardians of such minor would result in
p.001351: physical injury to such minor; and
p.001351: (C) assurances that the applicant will not require, with re- spect to the provision of services, the permission of the
p.001351: parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to
p.001351: compel such minor to have an abortion;
p.001351: (23) assurances that primary emphasis for services sup- ported under this title shall be given to
p.001351: adolescents seventeen and under who are not able to obtain needed assistance through other means;
p.001351: (24) assurances that funds received under this title shall supplement and not supplant funds received
p.001351: from any other Federal, State, or local program or any private sources of funds; and
p.001351: (25) a plan for the conduct of, and assurances that the ap- plicant will conduct, evaluations of the
p.001351: effectiveness of the services supported under this title in accordance with sub- section (b).
p.001351: (b)(1) Each grantee which receives funds for a demonstration project for services under this title shall expend
p.001351: at least 1 per cen- tum but not in excess of 5 per centum of the amounts received under this title for
p.001351: the conduct of evaluations of the services sup- ported under this title. The Secretary may, for a particular
p.001351: grantee upon good cause shown, waive the provisions of the preceding sen- tence with respect to the amounts to
p.001351: be expended on evaluations, but may not waive the requirement that such evaluations be con- ducted.
p.001351: (2) Evaluations required by paragraph (1) shall be conducted by an organization or entity which is
p.001351: independent of the grantee providing services supported under this title. To assist in con- ducting the
p.001351: evaluations required by paragraph (1), each grantee shall develop a working relationship with a college or
p.001351: university lo- cated in the grantee’s State which will provide or assist in pro-
p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001351: Sec. 2007 PUBLIC HEALTH SERVICE ACT 1352
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p.001351: viding monitoring and evaluation of services supported under this title unless no college or university in the
p.001351: grantee’s State is willing or has the capacity to provide or assist in providing such moni- toring and
p.001351: assistance.
p.001351: (3) The Secretary may provide technical assistance with re- spect to the conduct of evaluations required
p.001351: under this subsection to any grantee which is unable to develop a working relationship with a college or
p.001351: university in the applicant’s State for the reasons described in paragraph (2).
p.001351: (c) Each grantee which receives funds for a demonstration project for services under this title shall
p.001351: make such reports con- cerning its use of Federal funds as the Secretary may require. Re- ports shall include, at
p.001351: such times as are considered appropriate by the Secretary, the results of the evaluations of the services
p.001351: sup- ported under this title.
p.001351: (d)(1) A grantee shall periodically notify the Secretary of the exact number of instances in which a
p.001351: grantee does not notify the parents or guardians of a pregnant unemancipated minor under subsection
p.001351: (a)(22)(B)(iii).
p.001351: (2) For purposes of subsection (a)(22)(B)(iii), the term ‘‘adult’’ means an adult as defined by State law.
p.001351: (e) Each applicant shall provide the Governor of the State in which the applicant is located a copy of each
p.001351: application submitted to the Secretary for a grant for a demonstration project for services under this title. The
p.001351: Governor shall submit to the applicant com- ments on any such application within the period of sixty
p.001351: days be- ginning on the day when the Governor receives such copy. The ap- plicant shall include the comments of
p.001351: the Governor with such ap- plication.
p.001351: (f) No application submitted for a grant for a demonstration project for care services under this title
p.001351: may be approved unless the Secretary is satisfied that core services shall be available through the
p.001351: applicant within a reasonable time after such grant is received.
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p.001351: January 30, 2020
p.001351: COORDINATION OF FEDERAL AND STATE PROGRAMS
p.001351: SEC. 2007. ø300z–6¿ (a) The Secretary shall coordinate Federal policies and programs providing services relating to the
p.001351: prevention of adolescent sexual relations and initial and recurrent adolescent pregnancies and providing
p.001351: care services for pregnant adolescents. In achieving such coordination, the Secretary shall—
p.001351: (1) require grantees who receive funds for demonstration projects for services under this title to report
p.001351: periodically to the Secretary concerning Federal, State, and local policies and pro- grams that interfere with the
p.001351: delivery of and coordination of pregnancy prevention services and other programs of care for pregnant
p.001351: adolescents and adolescent parents;
p.001351: (2) provide technical assistance to facilitate coordination by State and local recipients of Federal assistance;
p.001351: (3) review all programs administered by the Department of Health and Human Services which provide prevention services
p.001351: or care services to determine if the policies of such programs are consistent with the policies of this
p.001351: title, consult with other
p.001351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001353: 1353
p.001353: PUBLIC HEALTH SERVICE ACT
p.001353: Sec. 2008
p.001353:
p.001353: departments and agencies of the Federal Government who ad- minister programs that provide such services, and
p.001353: encourage such other departments and agencies to make recommenda- tions, as appropriate, for legislation to
p.001353: modify such programs in order to facilitate the use of all Government programs which provide such services as a
p.001353: basis for delivery of more com- prehensive prevention services and more comprehensive pro- grams of care for
p.001353: pregnant adolescents and adolescent parents;
p.001353: (4) give priority in the provision of funds, where appro- priate, to applicants using single or coordinated
p.001353: grant applica- tions for multiple programs; and
p.001353: (5) give priority, where appropriate, to the provision of funds under Federal programs administered by
p.001353: the Secretary (other than the program established by this title) to projects providing comprehensive
p.001353: prevention services and comprehen- sive programs of care for pregnant adolescents and adolescent parents.
p.001353: (b) Any recipient of a grant for a demonstration project for services under this title shall coordinate
p.001353: its activities with any other recipient of such a grant which is located in the same local- ity.
p.001353: RESEARCH
p.001353: SEC. 2008. ø300z–7¿ (a)(1) The Secretary may make grants and enter into contracts with public agencies
p.001353: or private organiza- tions or institutions of higher education to support the research and dissemination
p.001353: activities described in paragraphs (4), (5), and
p.001353: (6) of section 2001(b).
p.001353: (2) The Secretary may make grants or enter into contracts under this section for a period of one year.
p.001353: A grant or contract under this section for a project may be renewed for four additional one-year periods, which
p.001353: need not be consecutive.
p.001353: (3) A grant or contract for any one-year period under this sec- tion may not exceed $100,000 for the direct costs of
p.001353: conducting re- search or disemination 1 activities under this section and may in- clude such additional
p.001353: amounts for the indirect costs of conducting such activities as the Secretary determines appropriate. The
p.001353: Sec- retary may waive the preceding sentence with respect to a specific project if he determines that—
p.001353: (A) exceptional circumstances warrant such waiver and that the project will have national impact; or
p.001353: (B) additional amounts are necessary for the direct costs of conducting limited demonstration projects for the
p.001353: provision of necessary services in order to provide data for research carried out under this title.
p.001353: (4) The amount of any grant or contract made under this sec- tion may remain available for obligation
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p.001355: the activities of such officer or employee in carrying out such provisions.
p.001355: AUTHORIZATION OF APPROPRIATIONS
p.001355: SEC. 2010. ø300z–9¿ (a) For the purpose of carrying out this title, there are authorized to be
p.001355: appropriated $30,000,000 for the fiscal year ending September 30, 1982, $30,000,000 for the fiscal year
p.001355: ending September 30, 1983, $30,000,000 for the fiscal year ending September 30, 1984, and $30,000,000 for
p.001355: the fiscal year ending September 30, 1985.
p.001355: (b) At least two-thirds of the amounts appropriated to carry out this title shall be used to make
p.001355: grants for demonstration projects for services.
p.001355: (c) Not more than one-third of the amounts specified under subsection (b) for use for grants for demonstration
p.001355: projects for serv- ices shall be used for grants for demonstration projects for preven- tion services.
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p.001355: January 30, 2020
p.001355: RESTRICTIONS
p.001355: SEC. 2011. ø300z–10¿ (a) Grants or payments may be made only to programs or projects which do not
p.001355: provide abortions or abortion counseling or referral, or which do not subcontract with or make any payment to any
p.001355: person who provides abortions or abor- tion counseling or referral, except that any such program or project may
p.001355: provide referral for abortion counseling to a pregnant adoles- cent if such adolescent and the parents or
p.001355: guardians of such adoles- cent request such referral; and grants may be made only to projects
p.001355: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001355: Sec. 2101 PUBLIC HEALTH SERVICE ACT 1356
p.001355: or programs which do not advocate, promote, or encourage abor- tion.
p.001355: (b) The Secretary shall ascertain whether programs or projects comply with subsection (a) and take appropriate action
p.001355: if programs or projects do not comply with such subsection, including with- holding of funds.
p.001355: TITLE XXI—VACCINES
p.001355: Subtitle 1—National Vaccine Program
p.001355: ESTABLISHMENT
p.001355: SEC. 2101. ø300aa–1¿ The Secretary shall establish in the De- partment of Health and Human Services a National
p.001355: Vaccine Pro- gram to achieve optimal prevention of human infectious diseases through immunization and to
p.001355: achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a
p.001355: Director selected by the Secretary.
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p.001355: PROGRAM RESPONSIBILITIES
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p.001477: agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV-related
p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: PUBLIC HEALTH SERVICE ACT
p.001525: Sec. 2689
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p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
...

p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: 1635
p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
p.001635:
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p.001635: January 30, 2020
p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
...

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p.000499: of children in substance abusing families, including information on the age, gen-
p.000499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000499: Sec. 399A PUBLIC HEALTH SERVICE ACT 500
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p.000499: January 30, 2020
p.000499:
p.000499: der and ethnicity of the children, the composition and income of the family, and the source of health care finances.
p.000499: (o) DEFINITIONS.—For purposes of this section:
p.000499: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000499: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000499: relative of such a child, or other individual acting in such a role).
p.000499: (2) The term ‘‘children of substance abusers’’ means—
p.000499: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000499: a parental role regarding the children; and
p.000499: (B) children who have been prenatally exposed to alco- hol or other dangerous drugs.
p.000499: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000499: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims
p.000499: Settlement Act), that is rec- ognized as eligible for the special programs and services pro- vided by
p.000499: the United States to Indians because of their status as Indians.
...

p.000505: the semicolon probably should be a period.
p.000505: 98 The reference to subsection (d) probably should be a reference to subsection (e). Section 3106(l) of
p.000505: Public Law 106–310 (114 Stat. 1178) would redesignate subsection (d) as subsection
p.000505: (e) and make conforming changes in cross-references. One of the conforming changes would be to subsection
p.000505: (m), and would strike ‘‘(d)’’ and insert ‘‘(e)’’. The reference to subsection (d) appears in subsection (l), however,
p.000505: not subsection (m).
p.000505: 99 See footnote for subsection (l)(3)(B).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000507: 507
p.000507: PUBLIC HEALTH SERVICE ACT
p.000507: Sec. 399B
p.000507:
p.000507: shall include a quantitative estimate of the prevalence of alcohol and drug problems in families involved in
p.000507: the child welfare system, the barriers to treatment and prevention services facing these fami- lies, and policy
p.000507: recommendations for removing the identified bar- riers, including training for child welfare workers.
p.000507: (n) DEFINITIONS.—For purposes of this section:
p.000507: (1) The term ‘‘caretaker’’, with respect to a child of a sub- stance abuser, means any individual
p.000507: acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent,
p.000507: relative of such a child, or other individual acting in such a role).
p.000507: (2) The term ‘‘children of substance abusers’’ means—
p.000507: (A) children who have lived or are living in a house- hold with a substance abuser who is acting in
p.000507: a parental role regarding the children; and
p.000507: (B) children who have been prenatally exposed to alco- hol or other drugs.
p.000507: (3) The term ‘‘Indian tribe’’ means any tribe, band, nation, or other organized group or community of Indians,
p.000507: including any Alaska Native village (as defined in, or established pursu- ant to, the Alaska Native Claims Settlement
p.000507: Act), that is recog- nized as eligible for the special programs and services provided by the United States to Indians
p.000507: because of their status as Indi- ans.
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p.000017: by way of reim- bursement, and in such installments and on such conditions, as the Secretary deems necessary to
p.000017: carry out the purposes of such sec- tion.
p.000017: (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307
p.000017: shall be re- duced by—
p.000017: (A) amounts equal to the fair market value of any equip- ment or supplies furnished to such person by the
p.000017: Secretary for the purpose of carrying out the project with respect to which such grant or contract is made,
p.000017: and
p.000017: (B) amounts equal to the pay, allowances, traveling ex- penses, and related personnel expenses attributable to
p.000017: the per- formance of services by an officer or employee of the Govern- ment in connection with such
p.000017: project, if such officer or em- ployee was assigned or detailed by the Secretary to perform such
p.000017: services,
p.000017: but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as
p.000017: the case may be.
p.000017: (f) Contracts may be entered into under section 304 or 306 without regard to section 3324 of title 31, United
p.000017: States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5).
p.000017: HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION
p.000017: SEC. 310. 5 ø242o¿ (a) A conference of the health authorities in and among the several States shall be called
p.000017: annually by the Sec- retary. Whenever in his opinion the interests of the public health
p.000017:
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p.000017: January 30, 2020
p.000017: 5 Former section 309 was repealed by section 6103(d)(1)(B) of Public Law 101–239 (103 Stat. 2205).
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 89 PUBLIC HEALTH SERVICE ACT Sec. 310A
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p.000017: would be promoted by a conference, the Secretary may invite as many of such health authorities and officials
p.000017: of other State or local public or private agencies, institutions, or organizations to confer as he deems
p.000017: necessary or proper. Upon the application of health authorities of five or more States it shall be the
p.000017: duty of the Sec- retary to call a conference of all State health authorities joining in the request. Each State
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p.000119: officers or employees of the Federal Government and who represent the disciplines relevant to tuber-
p.000119: culosis elimination;
p.000119: (ii) members of public-private partnerships or pri- vate entities established to address the elimination of
p.000119: tuberculosis;
p.000119: (iii) members of national and international non- governmental organizations whose purpose is to elimi- nate
p.000119: tuberculosis;
p.000119: (iv) members from the general public who are knowledgeable with respect to tuberculosis elimination including
p.000119: individuals who have or have had tuber- culosis; and
p.000119: (v) scientists, physicians, laboratorians, and other health professionals who reside in a foreign country
p.000119: with a substantial incidence or prevalence of tuber- culosis, and who represent the specialties and dis-
p.000119: ciplines relevant to the research under consideration.
p.000119: (C) CERTAIN COMPONENTS OF PLAN.—In carrying out subparagraph (A), the Council shall, subject to the
p.000119: direc- tion or discretion of the Secretary—
p.000119: (i) consider recommendations for the involvement of the United States in continuing global and cross-
p.000119: border tuberculosis control activities in countries where a high incidence of tuberculosis directly
p.000119: affects the United States; and
p.000119: (ii) review the extent to which progress has been made toward eliminating tuberculosis.
p.000119: (4) BIENNIAL REPORT.—
p.000119: (A) IN GENERAL.—The Council shall submit a biennial report to the Secretary, as determined necessary by the
p.000119: Secretary, on the activities carried under this section. Each such report shall include the opinion
p.000119: of the Council on the extent to which its recommendations regarding the elimination of tuberculosis have been
p.000119: implemented, includ- ing with respect to—
p.000119: (i) activities under subsection (b); and
p.000119: (ii) the national plan referred to in paragraph (3).
p.000119: (B) PUBLIC.—The Secretary shall make a report sub- mitted under subparagraph (A) public.
p.000119: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000121: 121
p.000121: PUBLIC HEALTH SERVICE ACT
p.000121: Sec. 317E
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p.000121: January 30, 2020
p.000121: (5) COMPOSITION.—The Council shall be composed of—
p.000121: (A) ex officio representatives from the Centers for Dis- ease Control and Prevention, the National Institutes of
p.000121: Health, the United States Agency for International Devel- opment, the Agency for Healthcare Research and
p.000121: Quality, the Health Resources and Services Administration, the United States-Mexico Border Health
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p.000397: January 30, 2020
p.000397: sive license to the reference product sponsor with re- spect to the reference product, if a person not licensed
p.000397: by the reference product sponsor engaged in the mak- ing, using, offering to sell, selling, or importing into
p.000397: the United States of the biological product that is the subject of the subsection (k) application; and
p.000397: (ii) an identification of the patents on such list that the reference product sponsor would be prepared
p.000397: to license to the subsection (k) applicant.
p.000397: (B) LIST AND DESCRIPTION BY SUBSECTION (k) APPLI- CANT.—Not later than 60 days after receipt of the
p.000397: list under subparagraph (A), the subsection (k) applicant—
p.000397: (i) may provide to the reference product sponsor a list of patents to which the subsection (k) applicant be- lieves a
p.000397: claim of patent infringement could reasonably be asserted by the reference product sponsor if a per- son not
p.000397: licensed by the reference product sponsor en- gaged in the making, using, offering to sell, selling, or importing
p.000397: into the United States of the biological prod- uct that is the subject of the subsection (k) application;
p.000397: (ii) shall provide to the reference product sponsor, with respect to each patent listed by the reference
p.000397: product sponsor under subparagraph (A) or listed by the subsection (k) applicant under clause (i)—
p.000397: (I) a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion
p.000397: of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed by
p.000397: the commercial marketing of the biological product that is the subject of the sub- section (k) application;
p.000397: or
p.000397: (II) a statement that the subsection (k) appli- cant does not intend to begin commercial mar- keting of the
p.000397: biological product before the date that such patent expires; and
p.000397: (iii) shall provide to the reference product sponsor a response regarding each patent identified by the ref- erence
p.000397: product sponsor under subparagraph (A)(ii).
p.000397: (C) DESCRIPTION BY REFERENCE PRODUCT SPONSOR.— Not later than 60 days after receipt of the list and
p.000397: state- ment under subparagraph (B), the reference product spon- sor shall provide to the subsection (k) applicant a
p.000397: detailed statement that describes, with respect to each patent de- scribed in subparagraph (B)(ii)(I), on
p.000397: a claim by claim basis, the factual and legal basis of the opinion of the ref- erence product sponsor that such
p.000397: patent will be infringed by the commercial marketing of the biological product that is the subject of the
p.000397: subsection (k) application and a re- sponse to the statement concerning validity and enforce- ability
p.000397: provided under subparagraph (B)(ii)(I).
p.000397: (4) PATENT RESOLUTION NEGOTIATIONS.—
p.000397: (A) IN GENERAL.—After receipt by the subsection (k) applicant of the statement under paragraph (3)(C), the ref-
p.000397: erence product sponsor and the subsection (k) applicant
p.000397: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000397:
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p.000397: Sec. 351 PUBLIC HEALTH SERVICE ACT 398
p.000397:
p.000397: shall engage in good faith negotiations to agree on which, if any, patents listed under paragraph (3)
p.000397: by the sub- section (k) applicant or the reference product sponsor shall be the subject of an action for
p.000397: patent infringement under paragraph (6).
p.000397: (B) FAILURE TO REACH AGREEMENT.—If, within 15 days of beginning negotiations under subparagraph (A), the sub-
p.000397: section (k) applicant and the reference product sponsor fail to agree on a final and complete list of which, if any,
p.000397: pat- ents listed under paragraph (3) by the subsection (k) appli- cant or the reference product sponsor shall be
p.000397: the subject of an action for patent infringement under paragraph (6), the provisions of paragraph (5)
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p.000425: ar- rangements with a qualified individual at a facility dif- ferent from where the mammography
p.000425: examination is per- formed; and
p.000425: (C) provide for the processing of film produced by such equipment at the facility or under arrangements with a
p.000425: qualified individual at a facility different from where the mammography examination is performed.
p.000425: (c) ISSUANCE AND RENEWAL OF CERTIFICATES.—
p.000425: (1) IN GENERAL.—The Secretary may issue or renew a cer- tificate for a facility if the person or agent
p.000425: described in sub- section (d)(1)(A) meets the applicable requirements of sub- section (d)(1) with respect
p.000425: to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years.
p.000425: (2) TEMPORARY RENEWAL CERTIFICATE.—The Secretary may issue a temporary renewal certificate, for a
p.000425: period of not to exceed 45 days, to a facility seeking reaccreditation if the ac- creditation body has issued an
p.000425: accreditation extension, for a period of not to exceed 45 days, for any of the following:
p.000425: (A) The facility has submitted the required materials to the accreditation body within the
p.000425: established time frames for the submission of such materials but the ac- creditation body is unable to
p.000425: complete the reaccreditation process before the certification expires.
p.000425: (B) The facility has acquired additional or replacement equipment, or has had significant personnel changes or
p.000425: other unforeseen situations that have caused the facility to be unable to meet reaccreditation timeframes, but
p.000425: in the opinion of the accreditation body have not compromised the quality of mammography.
p.000425: (3) LIMITED PROVISIONAL CERTIFICATE.—The Secretary may, upon the request of an accreditation body, issue a
p.000425: limited provisional certificate to an entity to enable the entity to con- duct examinations for
p.000425: educational purposes while an onsite visit from an accreditation body is in progress. Such certificate shall be
p.000425: valid only during the time the site visit team from the accreditation body is physically in the facility, and
p.000425: in no case shall be valid for longer than 72 hours. The issuance of a cer- tificate under this paragraph, shall
p.000425: not preclude the entity from qualifying for a provisional certificate under paragraph (4).
p.000425:
p.000425:
p.000425:
p.000425:
p.000425: January 30, 2020
p.000425: 71 So in law. The article ‘‘a’’ appears before both ‘‘temporary renewal certificate’’ and ‘‘limited provisional
p.000425: certificate’’. See section 2(1)(C) of Public Law 108–365 (118 Stat. 1738).
p.000425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000425:
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p.000425: Sec. 354 PUBLIC HEALTH SERVICE ACT 426
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p.000441: clothing, or other supplies for the armed forces. Such regulations may provide that if upon ex- amination any such
p.000441: individual is found to be so infected, he may be detained for such time and in such manner as may be
p.000441: reason- ably necessary.
p.000441: QUARANTINE STATIONS
p.000441: SEC. 364. ø267¿ (a) Except as provided in title II of the Act of June 15, 1917, as amended (U.S.C., 1940
p.000441: edition, title 50, secs. 191–194), 74 the Surgeon General shall control, direct, and manage all United States
p.000441: quarantine stations, grounds, and anchorages, designate their boundaries, and designate the quarantine
p.000441: officers to be in charge thereof. With the approval of the President he shall from time to time select suitable sites
p.000441: for and establish such addi- tional stations, grounds, and anchorages in the States and posses- sions of the
p.000441: United States as in his judgment are necessary to pre- vent the introduction of communicable diseases into the States
p.000441: and possessions of the United States.
p.000441: (b) The Surgeon General shall establish the hours during which quarantine service shall be
p.000441: performed at each quarantine station, and, upon application by any interested party, may estab- lish
p.000441: quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as,
p.000441: in his opin- ion, require such extended service. He may restrict the perform- ance of quarantine inspection to
p.000441: hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of
p.000441: darkness. No vessel shall be required to undergo quar- antine inspection during the hours of darkness,
p.000441: unless the quar- antine officer at such quarantine station shall deem an immediate inspection necessary to protect
p.000441: the public health. Uniformity shall not be required in the hours during which quarantine inspection may
p.000441: be obtained at the various ports of the United States.
p.000441: (c) The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of
p.000441: employees of the United States Public Health Service, Foreign Quarantine Division, per- forming overtime
p.000441: duties including the operation of vessels, in con- nection with the inspection or quarantine treatment of
p.000441: persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or
p.000441: any place subject to the juris- diction thereof, hereinafter referred to as ‘‘employees of the Public Health
p.000441: Service’’, when required to be on duty between the hours of 6 o’clock postmeridian and 6 o’clock antemeridian
p.000441: (or between the hours of 7 o’clock postmeridian and 7 o’clock antemeridian at sta- tions which have a
p.000441: declared workday of from 7 o’clock antemeridian to 7 o’clock postmeridian), or on Sundays or holidays, such rate, in
p.000441: lieu of compensation under any other provision of law, to be fixed at two times the basic hourly rate for
...

p.000563: approved
p.000563: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000565: 565
p.000565: PUBLIC HEALTH SERVICE ACT
p.000565: Sec. 399V–4
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p.000565: January 30, 2020
p.000565: under subsection (a) and similar States not receiving such grants; and
p.000565: (E) a comparison, with regard to the measures de- scribed in paragraph (3), of—
p.000565: (i) States receiving grants under subsection (a);
p.000565: (ii) States that enacted, prior to the date of enact- ment of the Patient Protection and Affordable Care Act,
p.000565: any cap on non-economic damages; and
p.000565: (iii) States that have enacted, prior to the date of enactment of the Patient Protection and Affordable Care
p.000565: Act, a requirement that the complainant obtain an opinion regarding the merit of the claim, although the
p.000565: substance of such opinion may have no bearing on whether the complainant may proceed with a case.
p.000565: (3) MEASURES.—The evaluations under paragraph (2) shall analyze and make comparisons on the basis of—
p.000565: (A) the nature and number of disputes over injuries al- legedly caused by health care providers or health care
p.000565: or- ganizations;
p.000565: (B) the nature and number of claims in which tort liti- gation was pursued despite the existence of an alternative
p.000565: under subsection (a);
p.000565: (C) the disposition of disputes and claims, including the length of time and estimated costs to all parties;
p.000565: (D) the medical liability environment;
p.000565: (E) health care quality;
p.000565: (F) patient safety in terms of detecting, analyzing, and helping to reduce medical errors and adverse events;
p.000565: (G) patient and health care provider and organization satisfaction with the alternative under subsection (a) and
p.000565: with the medical liability environment; and
p.000565: (H) impact on utilization of medical services, appro- priately adjusted for risk.
p.000565: (4) FUNDING.—The Secretary shall reserve 5 percent of the amount appropriated in each fiscal year under
p.000565: subsection (k) to carry out this subsection.
p.000565: (h) MEDPAC AND MACPAC REPORTS.—
p.000565: (1) MEDPAC.—The Medicare Payment Advisory Commis- sion shall conduct an independent review of the alternatives to
p.000565: current tort litigation that are implemented under grants under subsection (a) to determine the
p.000565: impact of such alter- natives on the Medicare program under title XVIII of the So- cial Security Act, and
p.000565: its beneficiaries.
p.000565: (2) MACPAC.—The Medicaid and CHIP Payment and Ac- cess Commission shall conduct an independent review of
...

p.000971: consumers of services provided by such facilities and shall be persons familiar with the need for such
p.000971: services in urban or rural areas.
p.000971: (b) Each appointed member shall hold office for a term of four years, except that any member appointed to fill a
p.000971: vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be
p.000971: appointed for the remainder of such term. An appointed member shall not be eligible to serve
p.000971: continuously for more than two terms (whether beginning before or after enactment of this section) but shall be
p.000971: eligible for reappointment if he has not served immediately preceding his reappointment.
p.000971: (c) The Council shall meet as frequently as the Surgeon Gen- eral deems necessary, but not less than
p.000971: once each year. Upon re- quest by three or more members, it shall be the duty of the Sur- geon General
p.000971: to call a meeting of the Council.
p.000971: (d) The Council is authorized to appoint such special advisory or technical committees as may be useful
p.000971: in carrying out its func- tions.
p.000971: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000971:
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p.000973: 973
p.000973: PUBLIC HEALTH SERVICE ACT
p.000973: Sec. 645
p.000973:
p.000973: CONFERENCE OF STATE AGENCIES
p.000973: SEC. 642. ø291l¿ Whenever in his opinion the purposes of this title would be promoted by a conference, the Surgeon
p.000973: General may invite representatives of as many State agencies, designated in ac- cordance with section 604, to confer as
p.000973: he deems necessary or prop- er. A conference of the representatives of all such State agencies shall be
p.000973: called annually by the Surgeon General. Upon the applica- tion of five or more of such State agencies, it
p.000973: shall be the duty of the Surgeon General to call a conference of representatives of all State agencies
p.000973: joining in the request.
p.000973: STATE CONTROL OF OPERATIONS
p.000973: SEC. 643. ø291m¿ Except as otherwise specifically provided, nothing in this title shall be construed as
p.000973: conferring on any Federal office or employee the right to exercise any supervision or control over the
p.000973: administration, personnel, maintenance, or operation of any facility with respect to which any funds have
p.000973: been or may be expended under this title.
p.000973: LOANS FOR CERTAIN HOSPITAL EXPERIMENTATION PROJECTS
p.000973: SEC. 643A. ø291m–1¿ (a) In order to alleviate hardship on any recipient of a grant under section 636 of this title (as
p.000973: in effect im- mediately before the enactment of the Hospital and Medical Facili- ties Amendments of 1964) for a
p.000973: project for the construction of an experimental or demonstration facility having as its specific pur- pose
p.000973: the application of novel means for the reduction of hospital costs with respect to which there has
p.000973: been a substantial increase in the cost of such construction (over the estimated cost of such project on
p.000973: the basis of which such grant was made) through no fault of such recipient, the Secretary is
...

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p.001095: January 30, 2020
p.001095:
p.001095: 2011. After fiscal year 2011, such amounts shall be adjusted to pro- vide for a cost-of-attendance increase for
p.001095: the yearly loan rate and the aggregate of the loans.
p.001095: (b) Loans from any such student loan fund by any school shall be made on such terms and conditions as the
p.001095: school may deter- mine; subject, however, to such conditions, limitations, and require- ments as the Secretary
p.001095: may prescribe (by regulation or in the agreement with the school) with a view to preventing impairment
p.001095: of the capital of such fund to the maximum extent practicable in the light of the objective of
p.001095: enabling the student to complete his course of study; and except that—
p.001095: (1) such a loan may be made only to a student who (A) is in need of the amount of the loan to pursue a full-time or
p.001095: half- time course of study at the school leading to a baccalaureate or associate degree in nursing or an
p.001095: equivalent degree, or a di- ploma in nursing, or a graduate degree in nursing, (B) is capa- ble, in the opinion of the
p.001095: school, of maintaining good standing in such course of study, and (C) with respect to any student en- rolling in the
p.001095: school after June 30, 2000, is of financial need (as defined in regulations issued by the Secretary);
p.001095: (2) such a loan shall be repayable in equal or graduated periodic installments (with the right of the
p.001095: borrower to accel- erate repayment) over the ten-year period which begins nine months after the student
p.001095: ceases to pursue a full-time or half- time course of study at a school of nursing, excluding from such
p.001095: 10-year period all (A) periods (up to three years) of (i) ac- tive duty performed by the borrower as a member
p.001095: of a uni- formed service, or (ii) service as a volunteer under the Peace Corps Act, (B) periods (up to ten
p.001095: years) during which the bor- rower is pursuing a full-time or half-time course of study at a collegiate school of
p.001095: nursing leading to baccalaureate degree in nursing or an equivalent degree, or to graduate degree in nurs- ing, or
p.001095: is otherwise pursuing advanced professional training in nursing (or training to be a nurse anesthetist), and
p.001095: (C) such additional periods under the terms of paragraph (8) of this sub- section;
p.001095: (3) in the case of a student who received such a loan before September 29, 1995, an amount up to 85 per centum
p.001095: of any such loan made before such date (plus interest thereon) shall be canceled for full-time
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p.001259: (1) the financial operations of the facility, and
p.001259:
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p.001259: January 30, 2020
p.001259: 2 So in law. The comma probably should follow the ending quotations.
p.001259: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001261: 1261
p.001261: PUBLIC HEALTH SERVICE ACT
p.001261: Sec. 1627
p.001261:
p.001261: (2) the costs to the facility of providing health services in the facility and the charges made by the
p.001261: facility for providing such services,
p.001261: during the period with respect to which the statement is filed. (b)(1) Each entity receiving Federal assistance under
p.001261: this title
p.001261: shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount
p.001261: and disposition by such en- tity of the proceeds of such assistance, the total cost of the project in connection with
p.001261: which such assistance is given or used, the amount of that portion of the cost of the project
p.001261: supplied by other sources, and such other records as will facilitate an effective audit.
p.001261: (2) The Secretary and the Comptroller General of the United States, or any of their duly authorized
p.001261: representatives, shall have access for the purpose of audit and examination to any books, docu- ments, papers, and
p.001261: records of such entities which in the opinion of the Secretary or the Comptroller General may be related or
p.001261: perti- nent to the assistance referred to in paragraph (1).
p.001261: (c) Each such entity shall file at least annually with the Sec- retary a statement which shall be in
p.001261: such form, and contain such information, as the Secretary may require to accurately show—
p.001261: (1) the financial operations of the facility constructed or modernized with such assistance, and
p.001261: (2) the costs to such facility of providing health services in such facility, and the charges made for such
p.001261: services, during the period with respect to which the statement is filed.
p.001261: TECHNICAL ASSISTANCE
p.001261: SEC. 1626. ø300s–5¿ The Secretary shall provide (either through the Department of Health, Education,
p.001261: and Welfare or by contract) all necessary technical and other nonfinancial assistance to any public or
p.001261: other entity which is eligible to apply for assist- ance under this title to assist such entity in developing
p.001261: applications to be submitted to the Secretary under section 1621 or 1642. The Secretary shall make every
p.001261: effort to inform eligible applicants of the availability of assistance under this title.
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p.001261: January 30, 2020
p.001261: ENFORCEMENT OF ASSURANCES
p.001261: SEC. 1627. ø300s–6¿ The Secretary shall investigate and ascer- tain, on a periodic basis, with respect to each
...

p.001367: petition was filed,
p.001367: the special master or court shall notify the petitioner under such petition that the petitioner may
p.001367: withdraw the petition under sec- tion 2121(b) or the petitioner may choose under section 2121(b) to have
p.001367: the petition remain before the special master or court, as the case may be.
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p.001367: January 30, 2020
p.001367:
p.001367: DETERMINATION OF ELIGIBILITY AND COMPENSATION
p.001367: SEC. 2113. ø300aa–13¿ (a) GENERAL RULE.—
p.001367: (1) Compensation shall be awarded under the Program to a petitioner if the special master or court
p.001367: finds on the record as a whole—
p.001367: (A) that the petitioner has demonstrated by a prepon- derance of the evidence the matters required in the
p.001367: peti- tion by section 2111(c)(1), and
p.001367: (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition,
p.001367: or death de- scribed in the petition is due to factors unrelated to the ad- ministration of the vaccine described in
p.001367: the petition.
p.001367: The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by
p.001367: medical records or by medical opinion.
p.001367: (2) For purposes of paragraph (1), the term ‘‘factors unre- lated to the administration of the vaccine’’—
p.001367: (A) does not include any idiopathic, unexplained, un- known, hypothetical, or undocumentable cause, factor,
p.001367: in- jury, illness, or condition, and
p.001367: (B) may, as documented by the petitioner’s evidence or other material in the record, include infection, toxins, trau-
p.001367: ma (including birth trauma and related anoxia), or meta- bolic disturbances which have no known relation
p.001367: to the vaccine involved, but which in the particular case are shown to have been the agent or agents
p.001367: principally respon- sible for causing the petitioner’s illness, disability, injury, condition, or death.
p.001367: (b) MATTERS TO BE CONSIDERED.—
p.001367: (1) In determining whether to award compensation to a pe- titioner under the Program, the special master or
p.001367: court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
p.001367: (A) any diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained
p.001367: in the record regarding the nature, causation, and aggravation of
p.001367: As Amended Through P.L. 116-94, Enacted December 20, 2019
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Economic / Economic/Poverty

Searching for indicator poor:

Searching for indicator poverty:

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p.000115: Sec. 317D
p.000115:
p.000115: services or activities described in paragraphs (1) and (2) of such subsection;
p.000115: (2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the
p.000115: services or activi- ties described in such subsection is provided; and
p.000115: (3) to ensure that not more than 40 percent of the grant is expended to provide the services or
p.000115: activities described in paragraphs (3) through (6) of such section 11.
p.000115: (e) ADDITIONAL REQUIRED AGREEMENTS.—
p.000115: (1) PRIORITY FOR LOW-INCOME MEN.—The Secretary may not make a grant under subsection (a) unless the applicant
p.000115: in- volved agrees that low-income men, and men at risk of pros- tate cancer, will be given priority in
p.000115: the provision of services and activities pursuant to paragraphs (1) and (2) of such sub- section.
p.000115: (2) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under subsection
p.000115: (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or
p.000115: activities under the grant, such charge—
p.000115: (A) will be made according to a schedule of charges that is made available to the public;
p.000115: (B) will be adjusted to reflect the income of the man involved; and
p.000115: (C) will not be imposed on any man with an income of less than 100 percent of the official poverty
p.000115: line, as es- tablished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000115: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000115: (3) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PROGRAMS.—The Secretary may not make a grant
p.000115: under sub- section (a) unless the applicant involved agrees that the grant will not be expended to make payment for
p.000115: any item or service to the extent that payment has been made, or can reasonably be expected to be made, with
p.000115: respect to such item or service—
p.000115: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.000115: health benefits program; or
p.000115: (B) by an entity that provides health services on a pre- paid basis.
p.000115: (4) COORDINATION WITH OTHER PROSTATE CANCER PRO- GRAMS.—The Secretary may not make a grant under
p.000115: sub- section (a) unless the applicant involved agrees that the serv- ices and activities funded through the
p.000115: grant will be coordinated with other Federal, State, and local prostate cancer programs.
p.000115: (5) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Sec- retary may not make a grant under subsection (a)
p.000115: unless the applicant involved agrees that not more than 10 percent of the grant will be expended for
p.000115: administrative expenses with re- spect to the grant.
p.000115:
p.000115:
p.000115:
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p.000115: 11 So in law. Probably should be ‘‘subsection’’.
p.000115: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000133:
p.000133:
p.000133:
p.000133: January 30, 2020
p.000133:
p.000133: terms are defined in section 4 of the Indian Health Care Im- provement Act) to provide for the development
p.000133: of school-based dental sealant programs to improve the access of children to sealants.
p.000133: (2) USE OF FUNDS.—A State shall use amounts received under a grant under paragraph (1) to provide funds to
p.000133: eligible school-based entities or to public elementary or secondary schools to enable such entities
p.000133: or schools to provide children with access to dental care and dental sealant services. Such services
p.000133: shall be provided by licensed dental health profes- sionals in accordance with State practice licensing laws.
p.000133: (3) ELIGIBILITY.—To be eligible to receive funds under paragraph (1), an entity shall—
p.000133: (A) prepare and submit to the State an application at such time, in such manner and containing such informa-
p.000133: tion as the State may require; and
p.000133: (B) be a public elementary or secondary school—
p.000133: (i) that is located in an urban area in which and more than 50 percent of the student population is par-
p.000133: ticipating in Federal or State free or reduced meal pro- grams; or
p.000133: (ii) that is located in a rural area and, with re- spect to the school district in which the school
p.000133: is lo- cated, the district involved has a median income that is at or below 235 percent of the poverty
p.000133: line, as de- fined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902(2)).
p.000133: (d) ORAL HEALTH INFRASTRUCTURE.—
p.000133: (1) COOPERATIVE AGREEMENTS.—The Secretary, acting through the Director of the Centers for Disease
p.000133: Control and Prevention, shall enter into cooperative agreements with State, territorial, and Indian tribes or
p.000133: tribal organizations (as those terms are defined in section 4 of the Indian Health Care Im- provement
p.000133: Act) to establish oral health leadership and pro- gram guidance, oral health data collection and
p.000133: interpretation, (including determinants of poor oral health among vulnerable populations), a
p.000133: multi-dimensional delivery system for oral health, and to implement science-based programs (including
p.000133: dental sealants and community water fluoridation) to improve oral health.
p.000133: (2) AUTHORIZATION OF APPROPRIATIONS.—There is author-
p.000133: ized to be appropriated such sums as necessary to carry out this subsection for fiscal years 2010 through
p.000133: 2014.
p.000133: (e) DEFINITIONS.—For purposes of this section, the term ‘‘In- dian tribe’’ means an Indian tribe or tribal
p.000133: organization as defined in section 4(b) and section 4(c) of the Indian Self-Determination and Education
p.000133: Assistance Act.
p.000133: (f) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
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p.000149: Sec. 318A PUBLIC HEALTH SERVICE ACT 150
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p.000149: January 30, 2020
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p.000149: criteria for ensuring the quality of screening procedures for dis- eases described in subsection (a).
p.000149: (g) CONFIDENTIALITY.—The Secretary may make a grant under subsection (a) only if the applicant involved agrees, subject
p.000149: to appli- cable law, to maintain the confidentiality of information on individ- uals with respect to activities carried
p.000149: out under subsection (c).
p.000149: (h) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may make a grant under subsection (a)
p.000149: only if the appli- cant involved agrees that, if a charge is imposed for the provision of services or
p.000149: activities under the grant, such charge—
p.000149: (1) will be made according to a schedule of charges that is made available to the public;
p.000149: (2) will be adjusted to reflect the income of the individual involved; and
p.000149: (3) will not be imposed on any individual with an income of less than 150 percent of the official
p.000149: poverty line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary
p.000149: in accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000149: (i) LIMITATIONS ON CERTAIN EXPENDITURES.—The Secretary may make a grant under subsection (a) only if
p.000149: the applicant in- volved agrees that not less than 80 percent of the grant will be ex- pended for the purpose of
p.000149: carrying out paragraphs (1) through (7) of subsection (c).
p.000149: (j) REPORTS TO SECRETARY.—
p.000149: (1) COLLECTION OF DATA.—The Secretary may make a grant under subsection (a) only if the applicant
p.000149: involved agrees, with respect to any disease selected under subsection
p.000149: (b) for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a
p.000149: grant, a report providing—
p.000149: (A) the incidence of the disease among the population of individuals served by the applicant;
p.000149: (B) the number and demographic characteristics of in- dividuals in such population;
p.000149: (C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to
p.000149: which referrals have been made pursuant to subsection (c)(5);
p.000149: (D) an assessment of the extent to which the activities carried pursuant to subsection (a) have reduced the
p.000149: inci- dence of infertility in the geographic area involved; and
p.000149: (E) such other information as the Secretary may re- quire with respect to the project carried out with
p.000149: the grant.
p.000149: (2) UTILITY AND COMPARABILITY OF DATA.—The Secretary shall carry out activities for the purpose of ensuring the
p.000149: utility and comparability of data collected pursuant to paragraph (1).
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p.000261: 261
p.000261: PUBLIC HEALTH SERVICE ACT
p.000261: Sec. 330
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p.000261: January 30, 2020
p.000261: (C) efforts to secure, within the proposed catchment area of such center, financial and professional
p.000261: assistance and support for the project;
p.000261: (D) initiation and encouragement of continuing com- munity involvement in the development and operation of
p.000261: the project; and
p.000261: (E) proposed linkages between the center and other appropriate provider entities, such as health departments,
p.000261: local hospitals, and rural health clinics, to provide better coordinated, higher quality, and more
p.000261: cost-effective health care services.
p.000261: (2) LIMITATION.—Not more than two grants may be made under this subsection for the same project, except that
p.000261: upon a showing of good cause, the Secretary may make additional grant awards.
p.000261: (3) RECOGNITION OF HIGH POVERTY.—
p.000261: (A) IN GENERAL.—In making grants under this sub- section, the Secretary may recognize the unique needs
p.000261: of high poverty areas.
p.000261: (B) HIGH POVERTY AREA DEFINED.—For purposes of subparagraph (A), the term ‘‘high poverty area’’ means
p.000261: a catchment area which is established in a manner that is consistent with the factors in subsection
p.000261: (k)(3)(J), and the poverty rate of which is greater than the national average poverty rate as determined by the
p.000261: Bureau of the Census.
p.000261: (d) IMPROVING QUALITY OF CARE.—
p.000261: (1) SUPPLEMENTAL AWARDS.—The Secretary may award supplemental grant funds to health centers funded under
p.000261: this section to implement evidence-based models for increasing ac- cess to high-quality primary care
p.000261: services, which may include models related to—
p.000261: (A) improving the delivery of care for individuals with multiple chronic conditions;
p.000261: (B) workforce configuration;
p.000261: (C) reducing the cost of care;
p.000261: (D) enhancing care coordination;
p.000261: (E) expanding the use of telehealth and technology-en- abled collaborative learning and capacity building models;
p.000261: (F) care integration, including integration of behav- ioral health, mental health, or substance use disorder
p.000261: serv- ices; and
p.000261: (G) addressing emerging public health or substance use disorder issues to meet the health needs of the
p.000261: popu- lation served by the health center.
p.000261: (2) SUSTAINABILITY.—In making supplemental awards under this subsection, the Secretary may consider whether the
p.000261: health center involved has submitted a plan for continuing the activities funded under this subsection after
p.000261: supplemental funding is expended.
p.000261: (3) SPECIAL CONSIDERATION.—The Secretary may give spe- cial consideration to applications for supplemental
p.000261: funding under this subsection that seek to address significant barriers to access to care in areas with a
...

p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
p.000851: (3) will not be imposed on any such woman with an income of less than 185 percent of the official poverty
p.000851: line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000851: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000851: (k) REPORTS TO DIRECTOR.—A funding agreement for an award under subsection (a) is that the applicant involved
p.000851: will submit to the Director a report—
p.000851: (1) describing the utilization and costs of services provided under the award;
p.000851: (2) specifying the number of women served, the number of infants served, and the type and costs of services provided;
p.000851: and
p.000851: (3) providing such other information as the Director deter- mines to be appropriate.
p.000851: (l) REQUIREMENT OF APPLICATION.—The Director may make an award under subsection (a) only if an application for
p.000851: the award is submitted to the Director containing such agreements, and the ap- plication is in such form, is
p.000851: made in such manner, and contains such other agreements and such assurances and information as the Director
p.000851: determines to be necessary to carry out this section.
p.000851: (m) ALLOCATION OF AWARDS.—In making awards under sub- section (a), the Director shall give priority to
p.000851: an applicant that agrees to use the award for a program serving an area that is a rural area, an area
p.000851: designated under section 332 by the Secretary as a health professional shortage area, or an area
p.000851: determined by
p.000851: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000935: jurisdiction of the public entity involved, the entity has submitted to the Secretary, and has had approved
p.000935: by the Secretary, a plan for the development of a jurisdiction-wide system of care for community-based services
p.000935: for children with a serious emotional disturbance that specifies the progress the public entity has made in developing
p.000935: the jurisdiction- wide system, the extent of cooperation across agencies serving chil- dren in the establishment of the
p.000935: system, the Federal and non-Fed- eral resources currently committed to the establishment of the sys- tem, and the
p.000935: current gaps in community services and the manner in which the grant under section 561(a) will be
p.000935: expended to ad- dress such gaps and establish local systems of care.
p.000935: (c) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—A fund- ing agreement for a grant under section 561(a) is
p.000935: that, if a charge is imposed for the provision of services under the grant, such charge—
p.000935: (1) will be made according to a schedule of charges that is made available to the public;
p.000935: (2) will be adjusted to reflect the income of the family of the child involved; and
p.000935: (3) will not be imposed on any child whose family has in- come and resources of equal to or less than 100
p.000935: percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised
p.000935: by the Secretary in ac- cordance with section 673(2) of the Omnibus Budget Reconcili- ation Act of 1981.
p.000935: (d) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A funding agreement for a grant under
p.000935: section 561(a) is that the grant, and the non-Federal contributions made with re- spect to the grant,
p.000935: will not be expended to make payment for any item or service to the extent that payment has been
p.000935: made, or can reasonably be expected to be made, with respect to such item or service—
p.000935: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000935: health benefits program; or
p.000935: (2) by an entity that provides health services on a prepaid basis.
p.000935: (e) LIMITATION ON ADMINISTRATIVE EXPENSES.—A funding agreement for a grant under section 561(a) is
p.000935: that not more than 2 percent of the grant will be expended for administrative expenses incurred with respect to the
p.000935: grant by the public entity involved.
p.000935: (f) REPORTS TO SECRETARY.—A funding agreement for a grant under section 561(a) is that the public entity
p.000935: involved will annually submit to the Secretary (and provide a copy to the State involved) a report on the
p.000935: activities of the entity under the grant that in- cludes a description of the number of children
p.000935: provided access to systems of care operated pursuant to the grant, the demographic
p.000935: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000955: (a) the general manner in which the State agency shall deter- mine the priority of projects based on the relative need
p.000955: of different areas lacking adequate facilities of various types for which assist- ance is available under this
p.000955: part, giving special consideration—
p.000955: (1) in the case of projects for the construction of hospitals, to facilities serving areas with relatively small
p.000955: financial re- sources and, at the option of the State, rural communities;
p.000955: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000955: Sec. 604 PUBLIC HEALTH SERVICE ACT 956
p.000955:
p.000955: (2) in the case of projects for the construction of rehabilita- tion facilities, to facilities operated in connection
p.000955: with a univer- sity teaching hospital which will provide an integrated pro- gram of medical, psychological,
p.000955: social, and vocational evalua- tion and services under competent supervision;
p.000955: (3) in the case of projects for modernization of facilities, to facilities serving densely populated areas;
p.000955: (4) in the case of projects for construction or modernization of outpatient facilities, to any outpatient facility that
p.000955: will be lo- cated in, and provide services for residents of, an area deter- mined by the Secretary to be a
p.000955: rural or urban poverty area;
p.000955: (5) to projects for facilities which, alone or in conjunction with other facilities, will provide
p.000955: comprehensive health care, including outpatient and preventive care as well as hospitaliza- tion;
p.000955: (6) to facilities which will provide training in health or al- lied health professions; and
p.000955: (7) to facilities which will provide to a significant extent, for the treatment of alcoholism;
p.000955: (b) general standards of construction and equipment for facili- ties of different classes and in different
p.000955: types of location, for which assistance is available under this part;
p.000955: (c) criteria for determining needs for general hospital and long- term care beds, and needs for hospitals and
p.000955: other facilities for which aid under this part is available, and for developing plans for the distribution of such
p.000955: beds and facilities;
p.000955: (d) criteria for determining the extent to which existing facili- ties, for which aid under this part is
p.000955: available, are in need of mod- ernization; and
p.000955: (e) that the State plan shall provide for adequate hospitals, and other facilities for which aid under
p.000955: this part is available, for all persons residing in the State, and adequate hospitals (and such other facilities)
p.000955: to furnish needed services for persons unable to pay therefor. Such regulations may also require that before approval
p.000955: of an application for a project is recommended by a State agency to the Surgeon General for approval
p.000955: under this part, assurance shall be received by the State from the applicant that (1) the facility or
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p.000973: under section 601, the Federal share shall be the amount determined by the State agency designated in
p.000973: accordance with section 604, but not more than 662⁄3 per centum or the State’s allotment percentage,
p.000973: whichever is the lower, except that, if the State’s allotment per- centage is lower than 50 per centum,
p.000973: such allotment percentage shall be deemed to be 50 per centum for purposes of this para- graph.
p.000973: (3) Prior to the approval of the first project in a State during any fiscal year the State agency
p.000973: designated in accordance with sec- tion 604 shall give the Secretary written notification of the max- imum
p.000973: Federal share established pursuant to paragraph (2) for projects in such State to be approved by the Secretary
p.000973: during such fiscal year and the method for determining the actual Federal share to be paid with respect to
p.000973: such projects; and such maximum Federal share and such method of determination for projects in such State
p.000973: approved during such fiscal year shall not be changed after such approval.
p.000973: (4) Notwithstanding the provisions of paragraphs (2) and (3) of this subsection, the Federal share shall, at the option
p.000973: of the State agency, be equal to the per centum provided under such para- graphs plus an incentive per
p.000973: centum (which when combined with the per centum provided under such paragraphs shall not exceed
p.000973: 90 per centum) specified by the State agency in the case of (A) projects that will provide services
p.000973: primarily for persons in an area determined by the Secretary to be a rural or urban poverty area, and (B)
p.000973: projects that offer potential for reducing health care costs through shared services among health care
p.000973: facilities, through inter- facility cooperation, or through the construction or modernization of free-standing
p.000973: outpatient facilities.
p.000973: (c) The term ‘‘hospital’’ includes general, tuberculosis, and other types of hospitals, and related
p.000973: facilities, such as laboratories, outpatient departments, nurses’ home facilities, extended care fa- cilities,
p.000973: facilities related to programs for home health services, self- care units, and central service facilities,
p.000973: operated in connection with hospitals, and also includes education or training facilities for health professions
p.000973: personnel operated as an integral part of a hos- pital, but does not include any hospital furnishing primarily domi-
p.000973: ciliary care.
p.000973: (d) The term ‘‘public health center’’ means a publicly owned fa- cility for the provision of public health
p.000973: services, including related publicly owned facilities such as laboratories, clinics, and adminis- trative offices
p.000973: operated in connection with such a facility.
p.000973: (e) The term ‘‘nonprofit’’ as applied to any facility means a fa- cility which is owned and operated by one or
p.000973: more nonprofit cor- porations or associations no part of the net earnings of which in- ures, or may
p.000973: lawfully inure, to the benefit of any private share- holder or individual.
p.000973: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000973:
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p.001243: (C) STATE.—The term ‘‘State’’ means each of the sev- eral States of the United States, the District of
p.001243: Columbia, the Commonwealth of Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana
p.001243: Islands, the Re- public of the Marshall Islands, the Federated States of Mi- cronesia, the Republic of Palau, an
p.001243: Indian tribe, and a tribal organization.
p.001243: (6) SUNSET.—The Secretary may not grant a waiver or ex- tension under this subsection after September 30, 2012.
p.001243: SEC. 1504. ø300n¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001243: (a) PRIORITY FOR LOW-INCOME WOMEN.—The Secretary may not make a grant under section 1501 unless the
p.001243: State involved agrees that low-income women will be given priority in the provi- sion of services and
p.001243: activities pursuant to paragraphs (1) and (2) of section 1501(a).
p.001243: (b) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under section
p.001243: 1501 unless the State involved agrees that, if a charge is imposed for the provision of services or activities under
p.001243: the grant, such charge—
p.001243: (1) will be made according to a schedule of charges that is made available to the public;
p.001243: (2) will be adjusted to reflect the income of the woman in- volved; and
p.001243: (3) will not be imposed on any woman with an income of less than 100 percent of the official poverty line,
p.001243: as established by the Director of the Office of Management and Budget and revised by the Secretary in
p.001243: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.001243: (c) STATEWIDE PROVISION OF SERVICES.—
p.001243: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001243:
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p.001243: Sec. 1504 PUBLIC HEALTH SERVICE ACT 1244
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p.001243: January 30, 2020
p.001243:
p.001243: (1) IN GENERAL.—The Secretary may not make a grant under section 1501 unless the State involved agrees that
p.001243: serv- ices and activities under the grant will be made available throughout the State, including availability
p.001243: to members of any Indian tribe or tribal organization (as such terms are defined in section 4 of the
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p.001247: Sec. 1602 PUBLIC HEALTH SERVICE ACT 1248
p.001247:
p.001247: (B) the conversion of unneeded hospital services and facili- ties to needed health services and medical
p.001247: facilities, including outpatient medical facilities and facilities for long-term care;
p.001247: (C) the renovation and modernization of medical facilities, particularly projects for the prevention or elimination of
p.001247: safety hazards, projects to avoid noncompliance with licensure or ac- creditation standards, or projects to
p.001247: replace obsolete facilities;
p.001247: (D) the construction of new outpatient medical facilities;
p.001247: and
p.001247: (E) the construction of new inpatient medical facilities in
p.001247: areas which have experienced (as determined by the Secretary) recent rapid population growth.
p.001247: (2)(A) The Secretary, during the period ending September 30, 1982, may, in accordance with this part, guarantee
p.001247: to—
p.001247: (i) non-Federal lenders for their loans to public and non- profit private entities for medical facilities
p.001247: projects described in paragraph (1), and
p.001247: (ii) the Federal Financing Bank for its loans to public and nonprofit private entities for such projects,
p.001247: payment of principal and interest on such loans.
p.001247: (B) In the case of a guarantee of any loan to a public or non- profit private entity under
p.001247: subparagraph (A)(i) which is located in an urban or rural poverty area, the Secretary may pay, to the hold- er of
p.001247: such loan and for and on behalf of the project for which the loan was made, amounts sufficient to reduce
p.001247: by not more than one- half the net effective interest rate otherwise payable on such loan if the Secretary
p.001247: finds that without such assistance the project could not be undertaken.
p.001247: (b) The principal amount of a loan directly made or guaranteed under subsection (a) for a medical facilities project,
p.001247: when added to any other assistance provided such project under part B, may not exceed 90 per centum of the
p.001247: cost of such project unless the project is located in an area determined by the Secretary to be an urban or
p.001247: rural poverty area, in which case the principal amount, when added to other assistance under part B,
p.001247: may cover up to 100 per centum of such costs.
p.001247: (c) The cumulative total of the principal of the loans out- standing at any time with respect to which
p.001247: guarantees have been issued, or which have been directly made, may not exceed such lim- itations as may be specified
p.001247: in appropriation Acts.
p.001247: (d) The Secretary, with the consent of the Secretary of Housing and Urban Development, shall obtain from the
p.001247: Department of Housing and Urban Development such assistance with respect to the administration of this part as
p.001247: will promote efficiency and econ- omy thereof.
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247: January 30, 2020
p.001247: GENERAL PROVISIONS RELATING TO LOAN GUARANTEES AND LOANS
p.001247: SEC. 1602. ø300q–2¿ (a)(1) The Secretary may not approve a loan guarantee for a project under this part
p.001247: unless he determines that (A) the terms, conditions, security (if any), and schedule and amount of
p.001247: repayments with respect to the loan are sufficient to protect the financial interests of the United
p.001247: States and are other- wise reasonable, including a determination that the rate of interest
p.001247: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001247:
p.001247:
p.001247:
p.001247:
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p.001247:
p.001247:
...

p.001249: such applicant in reliance thereon unless such per- son (or his successor in interest) engaged in fraud or misrepresen-
p.001249: tation in making or contracting to make such loan.
p.001249: (D) Guarantees of loans under this part shall be subject to such further terms and conditions as the
p.001249: Secretary determines to be necessary to assure that the purposes of this title will be achieved.
p.001249: (b)(1) The Secretary may not approve a loan under this part unless—
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
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p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249: January 30, 2020
p.001249: (A) the Secretary is reasonably satisfied that the applicant under the project for which the loan would be
p.001249: made will be able to make payments of principal and interest thereon when due, and
p.001249: (B) the applicant provides the Secretary with reasonable assurances that there will be available to it
p.001249: such additional funds as may be necessary to complete the project or under- taking with respect to which
p.001249: such loan is requested.
p.001249: (2) Any loan made under this part shall (A) have such security,
p.001249: (B) have such maturity date, (C) be repayable in such installments,
p.001249: (D) bear interest at a rate comparable to the current rate of inter- est prevailing, on the date the loan is
p.001249: made, with respect to loans guaranteed under this part, minus any interest subsidy made in accordance
p.001249: with section 1601(a)(2)(B) with respect to a loan made for a project located in an urban or rural poverty area,
p.001249: and (E) be subject to such other terms and conditions (including provisions for recovery in case of default), as the
p.001249: Secretary determines to be nec- essary to carry out the purposes of this title while adequately pro- tecting the
p.001249: financial interests of the United States.
p.001249: (3) The Secretary may, for good cause but with due regard to the financial interests of the United
p.001249: States, waive any right of re- covery which he has by reasons of the failure of a borrower to make
p.001249: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
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p.001249:
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p.001249:
p.001249: Sec. 1602 PUBLIC HEALTH SERVICE ACT 1250
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
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p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249:
p.001249: January 30, 2020
p.001249:
p.001249: payments of principal of and interest on a loan made under this part, except that if such loan is
p.001249: sold and guaranteed, any such waiver shall have no effect upon the Secretary’s guarantee of time- ly payment of
...

p.001253: authority, or pub- lic or quasi-public corporation, for any medical facility owned or operated by the State or
p.001253: political subdivision; and
p.001253: (ii) a nonprofit private entity for any medical facility owned or operated by the entity but only if
p.001253: the Secretary deter- mines—
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
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p.001253:
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p.001253:
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p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
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p.001253:
p.001253:
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p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253: January 30, 2020
p.001253: (I) the level of community service provided by the fa- cility and the proportion of its patients who are
p.001253: unable to pay for services rendered in the facility is similar to such level and proportion in a medical
p.001253: facility of a State or po- litical subdivision, and
p.001253: (II) that without a grant under subparagraph (A) there would be a disruption of the provision of health
p.001253: care to low-income individuals.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 75 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
p.001253: rural poverty area, in which case the grant may cover up to 100 per centum of such costs.
p.001253: (3) There are authorized to be appropriated for grants under paragraph (1) $40,000,000 for the fiscal year
p.001253: ending September 30, 1980, $50,000,000 for the fiscal year ending September 30, 1981, and $50,000,000 for
p.001253: the fiscal year ending September 30, 1982. Funds available for obligation under this subsection (as in
p.001253: effect before the date of the enactment of the Health Planning and Re- sources Development Amendments of
p.001253: 1979) in the fiscal year end- ing September 30, 1979, shall remain available for obligation under this subsection
p.001253: in the succeeding fiscal year.
p.001253: (b)(1) The Secretary may make grants to public and nonprofit private entities for projects for (A)
p.001253: construction or modernization of outpatient medical facilities which are located apart from hospitals and which will
p.001253: provide services for medically underserved popu- lations, and (B) conversion of existing facilities into
p.001253: outpatient medical facilities or facilities for long-term care to provide services for such populations.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 80 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
p.001253: rural poverty area, in which case the grant may cover up to 100 per centum of such costs.
p.001253: (3) There are authorized to be appropriated for grants under paragraph (1) $15,000,000 for the fiscal year
p.001253: ending September 30, 1981, and $15,000,000 for the fiscal year ending September 30, 1982.
p.001253: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001253:
p.001253:
p.001253:
p.001253:
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p.001253:
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p.001253:
p.001253:
p.001253: Sec. 1620 PUBLIC HEALTH SERVICE ACT
p.001253:
p.001253: PART C—GENERAL PROVISIONS
p.001254: 1254
p.001254:
p.001254: GENERAL REGULATIONS
p.001254: SEC. 1620. ø300s¿ The Secretary shall by regulation—
p.001254: (1) prescribe the manner in which he shall determine the priority among projects for which assistance is
p.001254: available under part A or B, based on the relative need of different areas for such projects and giving
p.001254: special consideration—
p.001254: (A) to projects for medical facilities serving areas with relatively small financial resources and for medical
p.001254: facili- ties serving rural communities,
p.001254: (B) in the case of projects for modernization of medical facilities, to projects for facilities serving densely
p.001254: populated areas,
p.001254: (C) in the case of projects for construction of out- patient medical facilities, to projects that will
p.001254: be located in, and provide services for residents of, areas determined by the Secretary to be rural or urban poverty
p.001254: areas,
p.001254: (D) to projects designed to (i) eliminate or prevent im- minent safety hazards as defined by Federal, State, or
p.001254: local fire, building, or life safety codes or regulations, or (ii) avoid noncompliance with State or voluntary
p.001254: licensure or accreditation standards, and
p.001254: (E) to projects for medical facilities which, alone or in conjunction with other facilities, will provide
p.001254: comprehen- sive health care, including outpatient and preventive care as well as hospitalization;
p.001254: (2) prescribe for medical facilities projects assisted under part A or B general standards of
p.001254: construction, modernization, and equipment, which standards may vary on the basis of the class of facilities and their
p.001254: location; and
p.001254: (3) prescribe the general manner in which easy entity which receives financial assistance under part A
p.001254: or B or has received financial assistance under part A or B or title VI shall be required to comply with the
p.001254: assurances required to be made at the time such assistance was received and the means by which such entity
p.001254: shall be required to demonstrate compliance with such assurances.
p.001254: An entity subject to the requirements prescribed pursuant to para- graph (3) respecting compliance with assurances
p.001254: made in connec- tion with receipt of financial assistance shall submit periodically to the Secretary data and
p.001254: information which reasonably supports the entity’s compliance with such assurances. The Secretary may not waive
p.001254: the requirement of the preceding sentence.
p.001254:
p.001254:
p.001254:
p.001254:
p.001254:
p.001254:
p.001254:
p.001254:
p.001254:
p.001254: January 30, 2020
p.001254:
p.001254: APPLICATIONS
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p.001255: (B) in the case of an application for a grant, assurances satisfactory to the Secretary that (i) the
p.001255: applicant making the application would not be able to complete the project for which the application is submitted
p.001255: without the grant applied for, and
p.001255: (ii) in the case of a project to construct a new medical facility, it would be inappropriate to convert an existing
p.001255: medical facility to provide the services to be provided through the new medical facility;
p.001255: (C) in the case of a project for the discontinuance of a serv- ice or facility or the conversion of a service
p.001255: or a facility, an evaluation of the impact of such discontinuance or conversion on the provision of
p.001255: health care in the health service area in which such service was provided or facility located;
p.001255: (D) a description of the site of such project;
p.001255: (E) plans and specifications therefor which meet the re- quirements of the regulations prescribed under section
p.001255: 1620(2);
p.001255: (F) reasonable assurance that title to such site is or will be vested in one or more of the entities
p.001255: filing the application or in a public or other nonprofit entity which is to operate the facility on completion of the
p.001255: project;
p.001255: (G) reasonable assurance that adequate financial support will be available for the completion of the
p.001255: project and for its maintenance and operation when completed, and, for the pur- pose of determining if
p.001255: the requirements of this subparagraph are met, Federal assistance provided directly to a medical facil- ity which
p.001255: is located in an area determined by the Secretary to be an urban or rural poverty area or through benefits provided
p.001255: individuals served at such facility shall be considered as finan- cial support;
p.001255: (H) the type of assistance being sought under part A or B for the project;
p.001255: (I) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the
p.001255: performance of work on a project will be paid wages at rates not less than those prevailing on similar
p.001255: construction in the locality as de- termined by the Secretary of Labor in accordance with the Act of March 3,
p.001255: 1931 (40 U.S.C. 276a—276a–5, known as the Davis-Bacon Act), and the Secretary of Labor shall have with
p.001255: respect to such labor standards the authority and functions set forth in Reorganization Plan Numbered 14 of 1950
p.001255: (15 FR 3176; 5 U.S.C. Appendix) and section 2 of the Act of June 13, 1934 (40 U.S.C. 276c);
p.001255: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001255:
p.001255:
p.001255:
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p.001255:
p.001255: Sec. 1622 PUBLIC HEALTH SERVICE ACT 1256
p.001255:
p.001255: (J) in the case of a project for the construction or mod- ernization of an outpatient facility,
p.001255: reasonable assurance that the services of a general hospital will be available to patients at such facility
p.001255: who are in need of hospital care; and
p.001255: (K) reasonable assurance that at all times after such appli- cation is approved (i) the facility or portion
...

p.001259: Enacted December 20, 2019
p.001259:
p.001259:
p.001259:
p.001259:
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p.001259:
p.001259: Sec. 1625 PUBLIC HEALTH SERVICE ACT 1260
p.001259:
p.001259: (10) The term ‘‘title,’’ 2 when used with reference to a site for a project, means a fee simple, or such
p.001259: other estate or inter- est (including a leasehold on which the rental does not exceed 4 per centum of the value
p.001259: of the land) as the Secretary finds sufficient to assure for a period of not less than twenty-five
p.001259: years’ undisturbed use and possession for the purposes of con- struction, modernization, or conversion and
p.001259: operation of the project for a period of not less than (A) twenty years in the case of a project
p.001259: assisted under an allotment or grant under this title, or (B) the term of repayment of a loan made or guar-
p.001259: anteed under this title in the case of a project assisted by a loan or loan guarantee.
p.001259: (11) The term ‘‘medical facility’’ means a hospital, public health center, outpatient medical facility,
p.001259: rehabilitation facil- ity, facility for long-term care, or other facility (as may be des- ignated by the Secretary)
p.001259: for the provision of health care to ambulatory patients.
p.001259: (12) The term ‘‘State Agency’’ means the State health plan- ning and development agency of a State designated under
p.001259: title XV.
p.001259: (13) The term ‘‘urban or rural poverty area’’ means an urban or rural geographical area (as defined by the
p.001259: Secretary) in which a percentage (as defined by the Secretary in accord- ance with the next sentence) of the
p.001259: residents of the area have incomes below the poverty level (as defined by the Secretary of Commerce). The percentage
p.001259: referred to in the preceding sen- tence shall be defined so that the percentage of the population of the United
p.001259: States residing in urban and rural poverty areas is—
p.001259: (A) not more than the percentage of the total popu- lation of the United States with incomes below the poverty
p.001259: level (as so defined) plus five per centum, and
p.001259: (B) not less than such percentage minus five per cen- tum.
p.001259: (14) The term ‘‘medically underserved population’’ means the population of an urban or rural area designated by
p.001259: the Sec- retary as an area with a shortage of health facilities or a popu- lation group designated by the Secretary as
p.001259: having a shortage of such facilities.
p.001259: FINANCIAL STATEMENTS; RECORDS AND AUDIT
p.001259: SEC. 1625. ø300s–4¿ (a) In the case of any facility for which an allotment payment, grant, loan, or
p.001259: loan guarantee has been made under this title, the applicant for such payment, grant, loan, or loan guarantee (or,
p.001259: if appropriate, such other person as the Sec- retary may prescribe) shall file at least annually with the
p.001259: State Agency for the State in which the facility is located a statement which shall be in such form,
p.001259: and contain such information, as the Secretary may require to accurately show—
p.001259: (1) the financial operations of the facility, and
p.001259:
p.001259:
p.001259:
p.001259: January 30, 2020
p.001259: 2 So in law. The comma probably should follow the ending quotations.
p.001259: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001259:
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p.001259:
p.001259:
p.001261: 1261
p.001261: PUBLIC HEALTH SERVICE ACT
p.001261: Sec. 1627
p.001261:
p.001261: (2) the costs to the facility of providing health services in the facility and the charges made by the
...

p.001263: posed to be discontinued by the applicant, (ii) in the case of an ap- plication for the conversion of a facility,
p.001263: determine the need for each service which will be provided as a result of a conversion, and
p.001263: (iii) make a recommendation to the State Agency for the State in which the applicant is located respecting
p.001263: approval by the Secretary of the applicant’s application.
p.001263: (B) A State Agency which has received a recommendation from a health systems agency under subparagraph (A) respecting
p.001263: an ap- plication shall, after consideration of such recommendation, make a recommendation to the Secretary
p.001263: respecting the approval by the Secretary of the application. A State Agency’s recommendation under this
p.001263: subparagraph respecting the approval of an application
p.001263: (i) shall be based upon (I) the need for each service or part pro- posed to be discontinued by the
p.001263: applicant, (II) in the case of an ap- plication for the conversion of a facility, the need for each service
p.001263: which will be provided as a result of the conversion, and (III) such other criteria as the Secretary may
p.001263: prescribe, and (ii) shall be ac- companied by the health systems agency’s recommendation made with respect
p.001263: to the approval of the application.
p.001263: (C) In determining, under subparagraphs (A) and (B), the need for the service (or services) or part proposed to
p.001263: be discontinued or converted by an applicant for a grant, a health systems agency and State Agency shall give
p.001263: special consideration to the unmet needs and existing access patterns of urban or rural poverty populations.
p.001263: (3)(A) The Secretary may not approve an application of a hos-
p.001263: pital for a grant—
p.001263: (i) if a State Agency recommended that the application not be approved, or
p.001263: (ii) if the Secretary is unable to determine that the cost of providing inpatient health services in the health
p.001263: service area in which the applicant is located will be less than if the inpa- tient health services proposed to be
p.001263: discontinued were not dis- continued.
p.001263: (B) In considering applications of hospitals for grants the Sec- retary shall consider the recommendations of
p.001263: health systems agen- cies and State Agencies and shall give special consideration to ap- plications (i) which will
p.001263: assist health systems agencies and State Agencies to meet the goals in their health systems plans and State
p.001263: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001263:
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p.001263:
p.001265: 1265
p.001265: PUBLIC HEALTH SERVICE ACT
p.001265: Sec. 1642
p.001265:
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p.001305: (iii) The amount determined under this clause is the sum of the respective amounts determined for the
p.001305: States (including the District of Columbia) by making, for each State, the same determination as is described
p.001305: in clause (ii) for the District of Columbia.
p.001305: (7) DETERMINATION OF TERM ‘‘P%’’.—For purposes of para- graph (4), the term ‘‘P%’’ means the percentage
p.001305: constituted by the ratio of the term ‘‘P’’ determined under paragraph (5) for the State involved to the sum
p.001305: of the respective terms ‘‘P’’ deter- mined for the States.
p.001305: (8) DETERMINATION OF CERTAIN FACTOR.—
p.001305: (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to
p.001305: adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under
p.001305: each of sub- paragraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist
p.001305: between the State and other States in the costs of providing comprehensive community mental health services to
p.001305: adults with a serious mental ill- ness and to children with a serious emotional disturbance.
p.001305: (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year
p.001305: in- volved shall be determined according to the methodology described in the report entitled ‘‘Adjusting
p.001305: the Alcohol, Drug Abuse and Mental Health Services Block Grant Allo- cations for Poverty Populations and Cost of
p.001305: Service’’, dated March 30, 1990, and prepared by Health Economics Re- search, a corporation, pursuant to a
p.001305: contract with the Na- tional Institute on Drug Abuse.
p.001305: (C) The factor determined under this paragraph for the State involved may not for any fiscal year be
p.001305: greater than 1.1 or less than 0.9.
p.001305: (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General,
p.001305: shall in accordance with this section make a determination for each State of the factor that is to be in effect
p.001305: for the State under this paragraph. The factor so determined shall re- main in effect through fiscal year 1994,
p.001305: and shall be recal- culated every third fiscal year thereafter.
p.001305: (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the
p.001305: Federal Register, periodically make such refinements in the meth- odology referred to in subparagraph (B) as are
p.001305: consistent with the purpose described in subparagraph (A).
p.001305: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001305:
p.001305:
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p.001307: 1307
p.001307: PUBLIC HEALTH SERVICE ACT
p.001307: Sec. 1919
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p.001421: statements.
p.001421: (c) AVAILABILITY TO PUBLIC.—The Secretary may not make payments under section 2401(a) unless the State involved
p.001421: agrees to make copies of the reports and audits described in this section available for public inspection.
p.001421: (d) EVALUATIONS BY COMPTROLLER GENERAL.—The Comp- troller General of the United States shall, from time to
p.001421: time, evalu- ate the expenditures by the States of payments under section 2401(a) in order to assure that
p.001421: expenditures are consistent with the provisions of this part.
p.001421: SEC. 2406. ø300dd–5¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001421: (a) 2 IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year unless
p.001421: the State involved agrees that—
p.001421: (1) the legislature of the State will conduct public hearings on the proposed use and distribution of the payments to
p.001421: be re- ceived from the allotments for each such fiscal year;
p.001421: (2)(A) the State will, to the maximum extent practicable, ensure that services provided to an individual
p.001421: pursuant to the program involved will be provided without regard to the ability of the individual to pay for such
p.001421: services and without regard to the current or past health condition of the individual;
p.001421: (B) if any charges are imposed for the provision of home and community-based health services for which
p.001421: assistance is provided under this part, such charges (i) will be pursuant to a public schedule of charges,
p.001421: (ii) will not be imposed on any eli- gible individual with an income that does not exceed 100 per- cent of
p.001421: the official poverty line, and (iii) for an eligible indi- vidual with an income that exceeds 100
p.001421: percent of the official
p.001421:
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p.001421: January 30, 2020
p.001421: 2 So in law. This section does not contain a subsection (b).
p.001421: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001421: Sec. 2407 PUBLIC HEALTH SERVICE ACT 1422
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p.001421: January 30, 2020
p.001421:
p.001421: poverty line, will be adjusted to reflect the income of the indi- vidual;
p.001421: (3) the State will provide for periodic independent peer re- view to assess the quality and appropriateness of
p.001421: home and community-based health services provided by entities that re- ceive funds from the State pursuant to
p.001421: section 2401(a);
p.001421: (4) the State will permit and cooperate with Federal inves- tigations undertaken under section 2409(e);
p.001421: (5) the State will maintain State expenditures for home and community-based health services for
p.001421: individuals infected with the etiologic agent for acquired immune deficiency syn- drome at a level equal
p.001421: to not less than the average level of such expenditures maintained by the State for the 2-year pe- riod
p.001421: preceding the fiscal year for which the State is applying to receive payments; and
p.001421: (6) the State will not make payments from allotments made under section 2401(a) for any item or service
p.001421: to the ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect
p.001421: to that item or service (i) under any State compensation program, under an insurance policy, under any
p.001421: Federal or State health benefits program, or
p.001421: (ii) by an entity that provides health services on a prepaid basis.
p.001421: SEC. 2407. ø300dd–6¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001421: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001421: (1) the State submits to the Secretary an application for the payments containing agreements in
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p.001425: Secretary. The Sec- retary shall, for the payment of expenses incurred in complying with such request, expend the
p.001425: amounts withheld.
p.001425: SEC. 2412. ø300dd–11¿ REPORT BY SECRETARY.
p.001425: Not later than March 1, 1990, the Secretary shall report to the Congress on the activities of the States under
p.001425: this part. Such re- port shall include a recommendation as to whether or not the pro- gram under this part
p.001425: should be extended beyond fiscal year 1990 and may include any recommendations of the Secretary for
p.001425: appro- priate administrative and legislative initiatives.
p.001425: SEC. 2413. ø300dd–12¿ DEFINITIONS.
p.001425: For purposes of this part:
p.001425: (1) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the same meaning given such terms in sections
p.001425: 4(b) and 4(c) of the Indian Self-Determination and Education Assistance Act.
p.001425:
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p.001425: January 30, 2020
p.001425: (2) The term ‘‘infected with the etiologic agent for acquired immune deficiency syndrome’’ includes any condition
p.001425: arising from infection with such etiologic agent.
p.001425: (3)(A) An individual is considered to have low income if the individual’s income does not exceed 200 percent of
p.001425: the official poverty line.
p.001425: (B) The term ‘‘official poverty line’’ refers, with respect to an individual, to the official poverty
p.001425: line defined by the Office of Management and Budget, and revised annually in accord- ance with section
p.001425: 673(2) of the Omnibus Budget Reconciliation Act of 1981, applicable to a family of the size involved.
p.001425: (4)(A) The term ‘‘State’’ means, except as provided in sub- paragraph (B), each of the several States, the
p.001425: District of Co- lumbia, the Commonwealth of Puerto Rico, and each territory of the United States.
p.001425: (B) For purposes of subsections (b) and (d) of section 2408, the term ‘‘State’’ means each of the several States, the
p.001425: District of Columbia, and the Commonwealth of Puerto Rico.
p.001425: (5) The term ‘‘territory of the United States’’ means each of the following: the Virgin Islands, Guam,
p.001425: American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001425: SEC. 2414. ø300dd–13¿ FUNDING.
p.001425: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making allotments under section 2401(a), there
p.001425: are authorized to be appropriated $100,000,000 for each of the fiscal years 1989 and 1990.
p.001425: (b) AVAILABILITY TO STATES.—Any amounts paid to a State or territory under section 2401(a) shall remain
p.001425: available to the State or territory until the expiration of the 1-year period beginning on the date on
p.001425: which the State or territory receives such amounts.
p.001425: SEC. 2415. ø300dd–14¿ SUNSET.
p.001425: Effective with respect to appropriations made for any period after fiscal year 1990, this part is repealed.
p.001425: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001425:
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p.001465:
p.001465: January 30, 2020
p.001465:
p.001465: not later than 45 days after the date on which appropriations are made under section 2677 for the fiscal
p.001465: year.
p.001465: (2) EXCEPTION.—The Secretary may extend the time for the submission of an application under paragraph (1) for a
p.001465: pe- riod of not to exceed 60 days if the Secretary determines that the eligible area has made a good
p.001465: faith effort to comply with the requirement of such paragraph but has otherwise been un- able to submit its
p.001465: application.
p.001465: (3) DISTRIBUTION BY SECRETARY.—Not later than 45 days after receiving an application that meets the
p.001465: requirements of subsection (a) from an eligible area, the Secretary shall dis- tribute to such eligible
p.001465: area the amounts awarded under the grant for which the application was submitted.
p.001465: (4) REDISTRIBUTION.—Any amounts appropriated in any fiscal year under this subpart and not obligated to
p.001465: an eligible entity as a result of the failure of such entity to submit an ap- plication shall be redistributed by the
p.001465: Secretary to other eligi- ble entities in proportion to the original grants made to such eligible areas under
p.001465: section 2601(a).
p.001465: (e) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001465: SERVICES.—
p.001465: (1) IN GENERAL.—The Secretary may not make a grant under section 2601 to an eligible area unless the
p.001465: eligible area provides assurances that in the provision of services with as- sistance provided under the
p.001465: grant—
p.001465: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the pro-
p.001465: vider will not impose charges on any such individual for the provision of services under the grant;
p.001465: (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the
p.001465: provider—
p.001465: (i) will impose a charge on each such individual for the provision of such services; and
p.001465: (ii) will impose the charge according to a schedule of charges that is made available to the public;
p.001465: (C) in the case of individuals with an income greater than 100 percent of the official poverty line
p.001465: and not ex- ceeding 200 percent of such poverty line, the provider will not, for any calendar year, impose
p.001465: charges in an amount exceeding 5 percent of the annual gross income of the indi- vidual involved;
p.001465: (D) in the case of individuals with an income greater than 200 percent of the official poverty line
p.001465: and not ex- ceeding 300 percent of such poverty line, the provider will not, for any calendar year, impose
p.001465: charges in an amount exceeding 7 percent of the annual gross income of the indi- vidual involved; and
p.001465: (E) in the case of individuals with an income greater than 300 percent of the official poverty line,
p.001465: the provider will not, for any calendar year, impose charges in an amount exceeding 10 percent of the
p.001465: annual gross income of the individual involved.
p.001465: (2) ASSESSMENT OF CHARGE.—With respect to compliance with the assurance made under paragraph (1), a grantee or
p.001465: en-
p.001465: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001467: 1467
p.001467: PUBLIC HEALTH SERVICE ACT
p.001467: Sec. 2607
p.001467:
p.001467: tity receiving assistance under this subpart may, in the case of individuals subject to a charge for purposes of
p.001467: such para- graph—
p.001467: (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal
p.001467: charge for the provision of services, subject to the provisions of such paragraph regarding public
p.001467: schedules and regarding limitations on the maximum amount of charges; and
p.001467: (B) take into consideration the medical expenses of in- dividuals in assessing the amount of the charge, subject to
p.001467: such provisions.
p.001467: (3) APPLICABILITY OF LIMITATION ON AMOUNT OF CHARGE.— The Secretary may not make a grant under section 2601 to an
p.001467: eligible area unless the eligible area agrees that the limitations established in subparagraphs (C), (D) and (E) of
p.001467: paragraph (1) regarding the imposition of charges for services applies to the annual aggregate of charges
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p.001483: with access to medical treatment for their HIV/ AIDS; and
p.001483: (E) describing efforts to remove legal barriers, includ- ing State laws and regulations, to routine testing.
p.001483: (c) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001483: SERVICES.—
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001483:
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p.001485: 1485
p.001485: PUBLIC HEALTH SERVICE ACT
p.001485: Sec. 2617
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p.001485: January 30, 2020
p.001485: (1) IN GENERAL.—The Secretary may not make a grant under section 2611 to a State unless the State provides
p.001485: assur- ances that in the provision of services with assistance provided under the grant—
p.001485: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the pro-
p.001485: vider will not impose charges on any such individual for the provision of services under the grant;
p.001485: (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the
p.001485: provider—
p.001485: (i) will impose charges on each such individual for the provision of such services; and
p.001485: (ii) will impose charges according to a schedule of charges that is made available to the public;
p.001485: (C) in the case of individuals with an income greater than 100 percent of the official poverty line
p.001485: and not ex- ceeding 200 percent of such poverty line, the provider will not, for any calendar year, impose
p.001485: charges in an amount exceeding 5 percent of the annual gross income of the indi- vidual involved;
p.001485: (D) in the case of individuals with an income greater than 200 percent of the official poverty line
p.001485: and not ex- ceeding 300 percent of such poverty line, the provider will not, for any calendar year, impose
p.001485: charges in an amount exceeding 7 percent of the annual gross income of the indi- vidual involved; and
p.001485: (E) in the case of individuals with an income greater than 300 percent of the official poverty line,
p.001485: the provider will not, for any calendar year, impose charges in an amount exceeding 10 percent of the
p.001485: annual gross income of the individual involved.
p.001485: (2) ASSESSMENT OF CHARGE.—With respect to compliance with the assurance made under paragraph (1), a grantee
p.001485: under section 2611 may, in the case of individuals subject to a charge for purposes of such paragraph—
p.001485: (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal
p.001485: charge for the provision of services, subject to the provisions of such paragraph regarding public schedules
p.001485: regarding limi- tation on the maximum amount of charges; and
p.001485: (B) take into consideration the medical expenses of in- dividuals in assessing the amount of the charge, subject to
p.001485: such provisions.
p.001485: (3) APPLICABILITY OF LIMITATION ON AMOUNT OF CHARGE.— The Secretary may not make a grant under section 2611
p.001485: unless the applicant of the grant agrees that the limitations estab- lished in subparagraphs (C), (D),
p.001485: and (E) of paragraph (1) re- garding the imposition of charges for services applies to the an- nual aggregate of
p.001485: charges imposed for such services, without regard to whether they are characterized as enrollment fees,
p.001485: premiums, deductibles, cost sharing, copayments, coinsurance, or other charges.
p.001485: (4) WAIVER.—
p.001485: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001515: PUBLIC HEALTH SERVICE ACT
p.001515: Sec. 2664
p.001515:
p.001515: (1) to undergo counseling and testing regarding HIV/AIDS without being required to provide any information
p.001515: relating to the identity of the individual; and
p.001515: (2) to undergo such counseling and testing through the use of a pseudonym.
p.001515: (c) PROHIBITION AGAINST REQUIRING TESTING AS CONDITION OF RECEIVING OTHER HEALTH SERVICES.—The
p.001515: Secretary may not make a grant under this part unless the applicant for the grant agrees that, with
p.001515: respect to an individual seeking health services from the applicant, the applicant will not require the
p.001515: individual to undergo testing for HIV as a condition of receiving any health serv- ices unless such testing is
p.001515: medically indicated in the provision of the health services sought by the individual.
p.001515: (d) MAINTENANCE OF SUPPORT.—The Secretary may not make a grant under this part unless the
p.001515: applicant for the grant agrees to maintain the expenditures of the applicant for early intervention services at a
p.001515: level equal to not less than the level of such expendi- tures maintained by the State for the fiscal year preceding the
p.001515: fis- cal year for which the applicant is applying to receive the grant.
p.001515: (e) REQUIREMENTS REGARDING IMPOSITION OF CHARGES FOR
p.001515: SERVICES.—
p.001515: (1) IN GENERAL.—The Secretary may not make a grant under this part unless, subject to paragraph (5), the
p.001515: applicant for the grant agrees that—
p.001515: (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the ap-
p.001515: plicant will not impose a charge on any such individual for the provision of early intervention services
p.001515: under the grant;
p.001515: (B) in the case of individuals with an income greater than 100 percent of the official poverty line,
p.001515: the appli- cant—
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p.001515: (i) will impose a charge on each such individual for the provision of such services; and
p.001515: (ii) will impose the charge according to a schedule of charges that is made available to the public.
p.001515: (2) LIMITATION ON CHARGES REGARDING INDIVIDUALS SUB- JECT TO CHARGES.—With respect to the imposition of a
p.001515: charge for purposes of paragraph (1)(B)(ii), the Secretary may not make a grant under this part unless,
p.001515: subject to paragraph (5), the applicant for the grant agrees that—
p.001515: (A) in the case of individuals with an income greater than 100 percent of the official poverty line
p.001515: and not ex- ceeding 200 percent of such poverty line, the applicant will not, for any calendar year, impose
p.001515: charges in an amount exceeding 5 percent of the annual gross income of the indi- vidual involved;
p.001515: (B) in the case of individuals with an income greater than 200 percent of the official poverty line
p.001515: and not ex- ceeding 300 percent of such poverty line, the applicant will not, for any calendar year, impose
p.001515: charges in an amount exceeding 7 percent of the annual gross income of the indi- vidual involved; and
p.001515: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001515: Sec. 2664 PUBLIC HEALTH SERVICE ACT 1516
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p.001515: (C) in the case of individuals with an income greater than 300 percent of the official poverty line, the
p.001515: applicant will not, for any calendar year, impose charges in an amount exceeding 10 percent of the
p.001515: annual gross income of the individual involved.
p.001515: (3) ASSESSMENT OF CHARGE.—With respect to compliance with the agreement made under paragraph (1),
p.001515: a grantee under this part may, in the case of individuals subject to a charge for purposes of such
p.001515: paragraph—
p.001515: (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal
p.001515: charge for the provision of services, subject to the provisions of such paragraph regarding public
p.001515: schedules and of para- graph (2) regarding limitations on the maximum amount of charges; and
p.001515: (B) take into consideration the medical expenses of in- dividuals in assessing the amount of the charge, subject to
p.001515: such provisions.
p.001515: (4) APPLICABILITY OF LIMITATION ON AMOUNT OF CHARGE.— The Secretary may not make a grant under this part
p.001515: unless the applicant for the grant agrees that the limitations estab- lished in paragraph (2) regarding the
p.001515: imposition of charges for services applies to the annual aggregate of charges imposed for such services, without
p.001515: regard to whether they are character- ized as enrollment fees, premiums, deductibles, cost sharing,
p.001515: copayments, coinsurance, or similar charges.
p.001515: (5) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—The requirement established in paragraph
p.001515: (1)(B)(i) shall be waived by the Secretary in the case of any entity for whom the Secretary has
p.001515: granted a waiver under section 2652(b)(2).
p.001515: (f) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO-
p.001515: GRAMS.—
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p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
p.001525: (C) NON-AIDS CASES.—The term ‘‘non-AIDS’’, with re- spect to a case of HIV, means that the individual involved
p.001525: has HIV but does not have AIDS.
p.001525: (8) HUMAN IMMUNODEFICIENCY VIRUS.—The term ‘‘human immunodeficiency virus’’ means the etiologic agent for AIDS.
p.001525: (9) OFFICIAL POVERTY LINE.—The term ‘‘official poverty line’’ means the poverty line established by the Director
p.001525: of the Office of Management and Budget and revised by the Secretary in accordance with section 673(2) of the Omnibus
p.001525: Budget Rec- onciliation Act of 1981.
p.001525: (10) PERSON.—The term ‘‘person’’ includes one or more in- dividuals, governments (including the Federal Government and
p.001525: the governments of the States), governmental agencies, polit- ical subdivisions, labor unions, partnerships,
p.001525: associations, cor- porations, legal representatives, mutual companies, joint-stock companies, trusts,
p.001525: unincorporated organizations, receivers, trustees, and trustees in cases under title 11, United States
p.001525: Code.
p.001525: (11) STATE.—
p.001525: (A) IN GENERAL.—The term ‘‘State’’ means each of the 50 States, the District of Columbia, and each of the
p.001525: terri- tories.
p.001525: (B) TERRITORIES.—The term ‘‘territory’’ means each of American Samoa, Guam, the Commonwealth of Puerto
p.001525: Rico, the Commonwealth of the Northern Mariana Islands,
p.001525: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001525: Sec. 2691 PUBLIC HEALTH SERVICE ACT 1526
p.001525:
p.001525: the Virgin Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and Palau.
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p.000113: (a) unless the applicant involved agrees that, in carrying out subsection (a)(3), the applicant will carry
p.000113: out education programs to communicate to men, and to local health officials, the significance of the early
p.000113: de- tection of prostate cancer.
p.000113: (d) REQUIREMENT OF PROVISION OF ALL SERVICES BY DATE CERTAIN.—The Secretary may not make a grant
p.000113: under subsection
p.000113: (a) unless the applicant involved agrees—
p.000113: (1) to ensure that, initially and throughout the period dur- ing which amounts are received pursuant to the grant, not
p.000113: less than 60 percent of the grant is expended to provide each of the
p.000113: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000113:
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p.000115: PUBLIC HEALTH SERVICE ACT
p.000115: Sec. 317D
p.000115:
p.000115: services or activities described in paragraphs (1) and (2) of such subsection;
p.000115: (2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the
p.000115: services or activi- ties described in such subsection is provided; and
p.000115: (3) to ensure that not more than 40 percent of the grant is expended to provide the services or
p.000115: activities described in paragraphs (3) through (6) of such section 11.
p.000115: (e) ADDITIONAL REQUIRED AGREEMENTS.—
p.000115: (1) PRIORITY FOR LOW-INCOME MEN.—The Secretary may not make a grant under subsection (a) unless the applicant
p.000115: in- volved agrees that low-income men, and men at risk of pros- tate cancer, will be given priority in
p.000115: the provision of services and activities pursuant to paragraphs (1) and (2) of such sub- section.
p.000115: (2) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under subsection
p.000115: (a) unless the applicant involved agrees that, if a charge is imposed for the provision of services or
p.000115: activities under the grant, such charge—
p.000115: (A) will be made according to a schedule of charges that is made available to the public;
p.000115: (B) will be adjusted to reflect the income of the man involved; and
p.000115: (C) will not be imposed on any man with an income of less than 100 percent of the official poverty
p.000115: line, as es- tablished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000115: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000115: (3) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PROGRAMS.—The Secretary may not make a grant
p.000115: under sub- section (a) unless the applicant involved agrees that the grant will not be expended to make payment for
p.000115: any item or service to the extent that payment has been made, or can reasonably be expected to be made, with
p.000115: respect to such item or service—
p.000115: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.000115: health benefits program; or
p.000115: (B) by an entity that provides health services on a pre- paid basis.
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p.000149: (8) providing to the public information and education on the prevention and control of the disease,
p.000149: including dissemi- nating such information; and
p.000149: (9) providing training to health care providers in carrying out the screenings and counseling described
p.000149: in paragraphs (1) and (3).
p.000149: (d) REQUIREMENT OF AVAILABILITY OF ALL SERVICES THROUGH EACH GRANTEE.—The Secretary may make a grant under
p.000149: sub- section (a) only if the applicant involved agrees that each activity authorized in subsection (c) will
p.000149: be available through the applicant. With respect to compliance with such agreement, the applicant may expend
p.000149: the grant to carry out any of the activities directly, and may expend the grant to enter into
p.000149: agreements with other public or nonprofit private entities under which the entities carry out the
p.000149: activities.
p.000149: (e) REQUIRED PROVIDERS REGARDING CERTAIN SERVICES.—The Secretary may make a grant under subsection (a) only if the
p.000149: appli- cant involved agrees that, in expending the grant to carry out ac- tivities authorized in subsection
p.000149: (c), the services described in para- graphs (1) through (7) of such subsection will be provided only through
p.000149: entities that are State or local health departments, grant- ees under section 329, 330, 340A, or 1001, or are
p.000149: other public or nonprofit private entities that provide health services to a signifi- cant number of
p.000149: low-income women.
p.000149: (f) QUALITY ASSURANCE REGARDING SCREENING FOR DIS-
p.000149: EASES.—For purposes of this section, the Secretary shall establish
p.000149: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000149:
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p.000149: Sec. 318A PUBLIC HEALTH SERVICE ACT 150
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p.000149: January 30, 2020
p.000149:
p.000149: criteria for ensuring the quality of screening procedures for dis- eases described in subsection (a).
p.000149: (g) CONFIDENTIALITY.—The Secretary may make a grant under subsection (a) only if the applicant involved agrees, subject
p.000149: to appli- cable law, to maintain the confidentiality of information on individ- uals with respect to activities carried
p.000149: out under subsection (c).
p.000149: (h) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may make a grant under subsection (a)
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p.000351: January 30, 2020
p.000351: SEC. 340. ø256¿ GRANTS TO STRENGTHEN THE EFFECTIVENESS, EFFI- CIENCY, AND COORDINATION OF SERVICES FOR THE
p.000351: UN- INSURED AND UNDERINSURED.
p.000351: (a) IN GENERAL.—The Secretary may award grants to eligible entities to assist in the development of integrated
p.000351: health care deliv- ery systems to serve communities of individuals who are uninsured and individuals who are
p.000351: underinsured—
p.000351: (1) to improve the efficiency of, and coordination among, the providers providing services through such
p.000351: systems;
p.000351: (2) to assist communities in developing programs targeted toward preventing and managing chronic diseases; and
p.000351: (3) to expand and enhance the services provided through such systems.
p.000351: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be an entity that—
p.000351: (1) represents a consortium—
p.000351: (A) whose principal purpose is to provide a broad range of coordinated health care services for a community
p.000351: defined in the entity’s grant application as described in paragraph (2); and
p.000351: (B) that includes at least one of each of the following providers that serve the community (unless such
p.000351: provider does not exist within the community, declines or refuses to participate, or places unreasonable conditions on
p.000351: their par- ticipation)—
p.000351: (i) a Federally qualified health center (as defined in section 1861(aa) of the Social Security Act
p.000351: (42
p.000351: U.S.C. 1395x(aa)));
p.000351: (ii) a hospital with a low-income utilization rate (as defined in section 1923(b)(3) of the Social Security Act
p.000351: (42 U.S.C. 1396r–4(b)(3)), that is greater than 25 percent;
p.000351: (iii) a public health department; and
p.000351: (iv) an interested public or private sector health care provider or an organization that has traditionally
p.000351: served the medically uninsured and underserved; and
p.000351: (2) submits to the Secretary an application, in such form and manner as the Secretary shall prescribe, that—
p.000351: (A) defines a community or geographic area of unin- sured and underinsured individuals;
p.000351: (B) identifies the providers who will participate in the consortium’s program under the grant, and specifies
p.000351: each provider’s contribution to the care of uninsured and under- insured individuals in the community, including
p.000351: the vol- ume of care the provider provides to beneficiaries under
p.000351: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000385: meaning given the term ‘‘teaching health center’’ in section 749A.
p.000385:
p.000385: Subpart XII—Community-Based Collaborative Care Network Program
p.000385: SEC. 340I. ø256i¿ COMMUNITY-BASED COLLABORATIVE CARE NET-
p.000385: WORK PROGRAM. 55
p.000385: (a) IN GENERAL.—The Secretary may award grants to eligible entities to support community-based
p.000385: collaborative care networks that meet the requirements of subsection (b).
p.000385:
p.000385:
p.000385:
p.000385:
p.000385: January 30, 2020
p.000385: 55 Section 301(c) of Public Law 115–63 provides for amendments to part D of the Public Health Service Act by
p.000385: redesignating the second subpart XI and the second section 340H as subpart XII
p.000385: Continued
p.000385: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000385:
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p.000385: Sec. 340I PUBLIC HEALTH SERVICE ACT 386
p.000385:
p.000385: (b) COMMUNITY-BASED COLLABORATIVE CARE NETWORKS.—
p.000385: (1) DESCRIPTION.—A community-based collaborative care network (referred to in this section as a
p.000385: ‘‘network’’) shall be a consortium of health care providers with a joint governance structure (including
p.000385: providers within a single entity) that pro- vides comprehensive coordinated and integrated health care services
p.000385: (as defined by the Secretary) for low-income popu- lations.
p.000385: (2) REQUIRED INCLUSION.—A network shall include the fol- lowing providers (unless such provider does not exist
p.000385: within the community, declines or refuses to participate, or places un- reasonable conditions on their participation):
p.000385: (A) A hospital that meets the criteria in section 1923(b)(1) of the Social Security Act; and
p.000385: (B) All Federally qualified health centers (as defined in section 1861(aa) of the Social Security Act located in
p.000385: the community.
p.000385: (3) PRIORITY.—In awarding grants, the Secretary shall give priority to networks that include—
p.000385: (A) the capability to provide the broadest range of services to low-income individuals;
p.000385: (B) the broadest range of providers that currently serve a high volume of low-income individuals; and
p.000385: (C) a county or municipal department of health.
p.000385: (c) APPLICATION.—
p.000385: (1) APPLICATION.—A network described in subsection (b) shall submit an application to the Secretary.
p.000385: (2) RENEWAL.—In subsequent years, based on the perform- ance of grantees, the Secretary may provide renewal grants to
p.000385: prior year grant recipients.
p.000385: (d) USE OF FUNDS.—
p.000385: (1) USE BY GRANTEES.—Grant funds may be used for the following activities:
p.000385: (A) Assist low-income individuals to—
p.000385: (i) access and appropriately use health services;
p.000385: (ii) enroll in health coverage programs; and
p.000385: (iii) obtain a regular primary care provider or a medical home.
p.000385: (B) Provide case management and care management.
p.000385: (C) Perform health outreach using neighborhood health workers or through other means.
p.000385: (D) Provide transportation.
p.000385: (E) Expand capacity, including through telehealth, after-hours services or urgent care.
p.000385: (F) Provide direct patient care services.
p.000385: (2) GRANT FUNDS TO HRSA GRANTEES.—The Secretary may limit the percent of grant funding that may be spent on direct
p.000385: care services provided by grantees of programs administered by the Health Resources and Services
p.000385: Administration or im- pose other requirements on such grantees deemed necessary.
p.000385:
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p.000385: January 30, 2020
p.000385: and section 340I, respectively. Such amendment probably should have included a reference to title III in
p.000385: the amendment instruction; however, such amendments were carried out to reflect the probable intent of
p.000385: Congress.
p.000385: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000387: PUBLIC HEALTH SERVICE ACT
p.000387: Sec. 351
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p.000479: 1998, and such sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000479: (b) TRAUMATIC BRAIN INJURY.—To carry out sections 393B and 393C, there are authorized to be appropriated $11,750,000
p.000479: for each of fiscal years 2020 through 2024.
p.000479:
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p.000479: January 30, 2020
p.000479: 89 So in law. Section 1306 of Public Law 106–310 (114 Stat. 1143) attempts to strike ‘‘and’’, but the
p.000479: amendment cannot be executed because the instructions were to strike ‘‘and’’ after ‘‘1994’’. (The word
p.000479: ‘‘and’’ appears after ‘‘1994,’’, not ‘‘1994’’.)
p.000479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000479:
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p.000479: Sec. 395 PUBLIC HEALTH SERVICE ACT 480
p.000479:
p.000479: PART K—HEALTH CARE SERVICES IN THE HOME AND PUBLIC HEALTH PROGRAMS FOR DEMENTIA 90
p.000479: Subpart I—Grants for Demonstration Projects
p.000479: SEC. 395. ø280c¿ ESTABLISHMENT OF PROGRAM.
p.000479: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000479: Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of
p.000479: assisting grantees in carrying out demonstration projects—
p.000479: (1) to identify low-income individuals who can avoid insti- tutionalization or prolonged hospitalization if 91 skilled
p.000479: nursing care services, homemaker or home health aide services, or per- sonal care services are provided in the
p.000479: homes of the individ- uals;
p.000479: (2) to pay the costs of the provision of such services in the homes of such individuals; and
p.000479: (3) to coordinate the provision by public and private enti- ties of such services, and other long-term
p.000479: care services, in the homes of such individuals.
p.000479: (b) REQUIREMENT WITH RESPECT TO AGE OF RECIPIENTS OF
p.000479: SERVICES.—The Secretary may not make a grant under subsection
p.000479: (a) to a State unless the State agrees to ensure that—
p.000479: (1) not less than 25 percent of the grant is expended to provide services under such subsection to
p.000479: individuals who are not less than 65 years of age; and
p.000479: (2) of the portion of the grant reserved by the State for purposes of complying with paragraph (1), not less
p.000479: than 10 per- cent is expended to provide such services to individuals who are not less than 85 years of age.
p.000479: (c) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a grant under
p.000479: sub- section (a) for any item or service to the extent that payment has been made, or can reasonably be
p.000479: expected to be made, with respect to such item or service—
p.000479: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000479: health benefits program; or
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p.000685: the Director under subsection (a) with similar activities conducted by other national research institutes
p.000685: and agencies of the National Institutes of Health to the extent that such Institutes and agencies have
p.000685: respon- sibilities that are related to breast cancer and other cancers of the reproductive system of women.
p.000685: (c) PROGRAMS FOR BREAST CANCER.—
p.000685: (1) IN GENERAL.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research to
p.000685: expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection
p.000685: shall provide for an expansion and intensification of the conduct and support of—
p.000685: (A) basic research concerning the etiology and causes of breast cancer;
p.000685: (B) clinical research and related activities concerning the causes, prevention, detection and treatment of
p.000685: breast cancer;
p.000685: (C) control programs with respect to breast cancer in accordance with section 412, including
p.000685: community-based programs designed to assist women who are members of
p.000685: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000685:
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p.000685: Sec. 417 PUBLIC HEALTH SERVICE ACT 686
p.000685:
p.000685: medically underserved populations, low-income popu- lations, or minority groups;
p.000685: (D) information and education programs with respect to breast cancer in accordance with section 413; and
p.000685: (E) research and demonstration centers with respect to breast cancer in accordance with section 414, including the
p.000685: development and operation of centers for breast cancer re- search to bring together basic and clinical, biomedical and
p.000685: behavioral scientists to conduct basic, clinical, epidemiolog- ical, psychosocial, prevention and treatment
p.000685: research and related activities on breast cancer.
p.000685: Not less than six centers shall be operated under subpara- graph (E). Activities of such centers should
p.000685: include supporting new and innovative research and training programs for new re- searchers. Such centers shall give
p.000685: priority to expediting the transfer of research advances to clinical applications.
p.000685: (2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—
p.000685: (A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are imple-
p.000685: mented in accordance with a plan for the programs. Such plan shall include comments and recommendations
p.000685: that the Director of the Institute considers appropriate, with due consideration provided to the
p.000685: professional judgment needs of the Institute as expressed in the annual budget estimate prepared in
p.000685: accordance with section 413(9) 16. The Director of the Institute, in consultation with the National Cancer Advisory
p.000685: Board, shall periodically review and re- vise such plan.
p.000685: (B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President’s
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p.000851:
p.000851:
p.000851:
p.000851: January 30, 2020
p.000851:
p.000851: Government, may not be included in determining the amount of such non-Federal contributions.
p.000851: (g) OUTREACH.—A funding agreement for an award under sub- section (a) for an applicant is that the applicant
p.000851: will provide out- reach services in the community involved to identify women who have a substance use
p.000851: disorder and to encourage the women to un- dergo treatment for such disorder.
p.000851: (h) ACCESSIBILITY OF PROGRAM; CULTURAL CONTEXT OF SERV- ICES.—A funding agreement for an award under
p.000851: subsection (a) for an applicant is that—
p.000851: (1) the program operated pursuant to such subsection will be operated at a location that is accessible to low-income
p.000851: preg- nant and postpartum women; and
p.000851: (2) authorized services will be provided in the language and the cultural context that is most appropriate.
p.000851: (i) CONTINUING EDUCATION.—A funding agreement for an award under subsection (a) is that the applicant
p.000851: involved will pro- vide for continuing education in treatment services for the individ- uals who will provide
p.000851: treatment in the program to be operated by the applicant pursuant to such subsection.
p.000851: (j) IMPOSITION OF CHARGES.—A funding agreement for an award under subsection (a) for an applicant
p.000851: is that, if a charge is imposed for the provision of authorized services to or on behalf of an eligible
p.000851: woman, such charge—
p.000851: (1) will be made according to a schedule of charges that is made available to the public;
p.000851: (2) will be adjusted to reflect the income of the woman in- volved; and
p.000851: (3) will not be imposed on any such woman with an income of less than 185 percent of the official poverty
p.000851: line, as estab- lished by the Director of the Office of Management and Budget and revised by the Secretary in
p.000851: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.000851: (k) REPORTS TO DIRECTOR.—A funding agreement for an award under subsection (a) is that the applicant involved
p.000851: will submit to the Director a report—
...

p.000999: The school may elect to add the amount of any such charge to the principal amount of the loan as of the first day after
p.000999: the day on which such installment or evidence was due, or to make the amount of the charge payable to the school not
p.000999: later than the due date of the next installment after receipt by the borrower of notice of the assessment of
p.000999: the charge.
p.000999: (j) AUTHORITY OF SCHOOLS REGARDING RATE OF PAYMENT.—A school may provide, in accordance with regulations
p.000999: of the Sec- retary, that during the repayment period of a loan from a loan fund established pursuant to an agreement
p.000999: under this subpart payments of principal and interest by the borrower with respect to all the outstanding
p.000999: loans made to him from loan funds so established shall be at a rate equal to not less than $40 per month.
p.000999: (k) AUTHORITY REGARDING REPAYMENTS BY SECRETARY.—Upon application by a person who received, and is under
p.000999: an obligation to repay, any loan made to such person as a health professions stu- dent to enable him to study
p.000999: medicine, osteopathy, dentistry, veteri- nary medicine, optometry, pharmacy, or podiatry, the Secretary may
p.000999: undertake to repay (without liability to the applicant) all or any part of such loan, and any interest
p.000999: or portion thereof out- standing thereon, upon his determination, pursuant to regulations establishing
p.000999: criteria therefor, that the applicant—
p.000999: (1) failed to complete such studies leading to his first pro- fessional degree;
p.000999: (2) is in exceptionally needy circumstances;
p.000999: (3) is from a low-income or disadvantaged family as those terms may be defined by such regulations; and
p.000999: (4) has not resumed, or cannot reasonably be expected to resume, the study of medicine, osteopathy,
p.000999: dentistry, veteri- nary medicine, optometry, pharmacy, or podiatric medicine, within two years following the
p.000999: date upon which he terminated such studies.
p.000999: (l) COLLECTION EFFORTS BY SECRETARY.—The Secretary is au- thorized to attempt to collect any loan which was made
p.000999: under this subpart, which is in default, and which was referred to the Sec- retary by a school with
p.000999: which the Secretary has an agreement under this subpart, on behalf of that school under such terms and conditions
p.000999: as the Secretary may prescribe (including reimburse- ment from the school’s student loan fund for
p.000999: expenses the Sec- retary may reasonably incur in attempting collection), but only if the school has
p.000999: complied with such requirements as the Secretary may specify by regulation with respect to the collection
p.000999: of loans under this subpart. A loan so referred shall be treated as a debt subject to section 5514 of
p.000999: title 5, United States Code. Amounts col- lected shall be deposited in the school’s student loan fund. When-
p.000999: ever the Secretary desires the institution of a civil action regarding any such loan, the Secretary shall refer the
p.000999: matter to the Attorney General for appropriate action.
p.000999: (m) ELIMINATION OF STATUTE OF LIMITATION FOR LOAN COL-
p.000999: LECTIONS.—
p.000999: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000999:
p.000999:
...

p.001111: (1) RESEARCH, EVALUATIONS AND DEMONSTRATION PROJECTS.—In carrying out this title, the
p.001111: Director shall con-
p.001111:
p.001111:
p.001111:
p.001111:
p.001111: January 30, 2020
p.001111: 1 Section 2 of Public Law 106–129 (113 Stat. 1653) designated the Agency as the Agency for Healthcare
p.001111: Research and Quality. Formerly it was designated as the Agency for Health Care Policy and Research. See
p.001111: section 6103 of Public Law 101–239 (103 Stat. 2189).
p.001111: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001111:
p.001111:
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p.001113: 1113
p.001113: PUBLIC HEALTH SERVICE ACT
p.001113: Sec. 902
p.001113:
p.001113: duct and support research and evaluations, and support dem- onstration projects, with respect to—
p.001113: (A) the delivery of health care in inner-city areas, and in rural areas (including frontier areas); and
p.001113: (B) health care for priority populations, which shall in- clude—
p.001113:
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p.001113:
p.001113:
p.001113:
p.001113: January 30, 2020
p.001113: (i) low-income groups;
p.001113: (ii) minority groups;
p.001113: (iii) women;
p.001113: (iv) children;
p.001113: (v) the elderly; and
p.001113: (vi) individuals with special health care needs, in- cluding individuals with disabilities and individuals who
p.001113: need chronic care or end-of-life health care.
p.001113: (2) PROCESS TO ENSURE APPROPRIATE RESEARCH.—The Di- rector shall establish a process to ensure that the
p.001113: requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by
p.001113: the Agency.
p.001113: (3) OFFICE OF PRIORITY POPULATIONS.—The Director shall establish an Office of Priority Populations to assist in
p.001113: carrying out the requirements of paragraph (1).
p.001113: SEC. 902. ø299a¿ GENERAL AUTHORITIES.
p.001113: (a) IN GENERAL.—In carrying out section 901(b), the Director shall conduct and support research, evaluations,
p.001113: and training, sup- port demonstration projects, research networks, and multidisci- plinary centers, provide
p.001113: technical assistance, and disseminate in- formation on health care and on systems for the delivery of
p.001113: such care, including activities with respect to—
p.001113: (1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
p.001113: (2) quality measurement and improvement;
p.001113: (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services;
p.001113: (4) clinical practice, including primary care and practice- oriented research;
...

p.001143: PUBLIC HEALTH SERVICE ACT
p.001143: Sec. 934
p.001143:
p.001143: ment organization, patient safety organization, local qual- ity improvement collaborative, the Joint Commission,
p.001143: aca- demic health center, university, physician-based research network, primary care extension program
p.001143: established under section 399V–1, a Federal Indian Health Service program or a health program operated by
p.001143: an Indian tribe (as defined in section 4 of the Indian Health Care Improve- ment Act), or any other entity identified
p.001143: by the Secretary; and
p.001143: (B) shall have demonstrated expertise in providing in- formation and technical support and assistance to health
p.001143: care providers regarding quality improvement.
p.001143: (2) IMPLEMENTATION AWARD.—To be eligible to receive an implementation grant or contract under subsection
p.001143: (a)(2), an entity—
p.001143: (A) may be a hospital or other health care provider or consortium or providers, as determined by the Secretary;
p.001143: and
p.001143: (B) shall have demonstrated expertise in providing in- formation and technical support and assistance to health
p.001143: care providers regarding quality improvement.
p.001143: (c) APPLICATION.—
p.001143: (1) TECHNICAL ASSISTANCE AWARD.—To receive a technical assistance grant or contract under subsection (a)(1), an
p.001143: eligible entity shall submit an application to the Secretary at such time, in such manner, and containing—
p.001143: (A) a plan for a sustainable business model that may include a system of—
p.001143: (i) charging fees to institutions and providers that receive technical support from the entity; and
p.001143: (ii) reducing or eliminating such fees for such in- stitutions and providers that serve low-income popu-
p.001143: lations; and
p.001143: (B) such other information as the Director may re- quire.
p.001143: (2) IMPLEMENTATION AWARD.—To receive a grant or con- tract under subsection (a)(2), an eligible entity shall
p.001143: submit an application to the Secretary at such time, in such manner, and containing—
p.001143: (A) a plan for implementation of a model or practice identified in the research conducted by the Center
p.001143: includ- ing—
p.001143:
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p.001143: January 30, 2020
p.001143: (i) financial cost, staffing requirements, and timeline for implementation; and
p.001143: (ii) pre- and projected post-implementation quality measure performance data in targeted improvement areas
p.001143: identified by the Secretary; and
p.001143: (B) such other information as the Director may re- quire.
p.001143: (d) MATCHING FUNDS.—The Director may not award a grant or contract under this section to an entity unless the
p.001143: entity agrees that it will make available (directly or through contributions from other public or private
p.001143: entities) non-Federal contributions toward the activities to be carried out under the grant or contract
p.001143: in an
p.001143: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001143:
p.001143:
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p.001143: Sec. 935 PUBLIC HEALTH SERVICE ACT 1144
p.001143:
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p.001161: January 30, 2020
p.001161:
p.001161: REGULATIONS AND PAYMENTS
p.001161:
p.001161: SEC. 1006. ø300a–4¿ (a) Grants and contracts made under this title shall be made in accordance with such regulations as
p.001161: the Sec- retary may promulgate. The amount of any grant under any sec- tion of this title shall be
p.001161: determined by the Secretary; except that no grant under any such section for any program or project for
p.001161: a fiscal year beginning after June 30, 1975, may be made for less than 90 per centum of its costs
p.001161: (as determined under regulations of the Secretary) unless the grant is to be made for a program or
p.001161: project for which a grant was made (under the same section) for the fiscal year ending June 30, 1975,
p.001161: for less than 90 per centum of its costs (as so determined), in which case a grant under such section
p.001161: for that program or project for a fiscal year beginning after that date may be made for a percentage which
p.001161: shall not be less than the percentage of its costs for which the fiscal year 1975 grant was made.
p.001161: (b) Grants under this title shall be payable in such install- ments and subject to such conditions as
p.001161: the Secretary may deter- mine to be appropriate to assure that such grants will be effectively utilized for the
p.001161: purposes for which made.
p.001161: (c) A grant may be made or contract entered into under section 1001 or 1002 for a family planning service project or
p.001161: program only upon assurances satisfactory to the Secretary that—
p.001161: (1) priority will be given in such project or program to the furnishing of such services to persons from
p.001161: low-income fami- lies; and
p.001161: (2) no charge will be made in such project or program for services provided to any person from a
p.001161: low-income family ex- cept to the extent that payment will be made by a third party
p.001161: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001161:
p.001161:
p.001161:
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p.001161:
p.001161: Sec. 1007 PUBLIC HEALTH SERVICE ACT 1162
p.001161:
p.001161: (including a government agency) which is authorized or is under legal obligation to pay such charge.
p.001161: For purposes of this subsection, the term ‘‘low-income family’’ shall be defined by the Secretary in accordance with
p.001161: such criteria as he may prescribe so as to insure that economic status shall not be a deterrent to
p.001161: participation in the programs assisted under this title. (d)(1) A grant may be made or a contract entered
p.001161: into under section 1001 or 1005 only upon assurances satisfactory to the Sec- retary that informational or
p.001161: educational materials developed or made available under the grant or contract will be suitable for the purposes of
p.001161: this title and for the population or community to which they are to be made available, taking into account the
p.001161: educational and cultural background of the individuals to whom such materials are addressed and the standards of such
p.001161: population or community
p.001161: with respect to such materials.
p.001161: (2) In the case of any grant or contract under section 1001, such assurances shall provide for the
p.001161: review and approval of the suitability of such materials, prior to their distribution, by an advi- sory committee
p.001161: established by the grantee or contractor in accord- ance with the Secretary’s regulations. Such a
p.001161: committee shall in- clude individuals broadly representative of the population or com- munity to which the
p.001161: materials are to be made available.
p.001161: VOLUNTARY PARTICIPATION
p.001161: SEC. 1007. ø300a–5¿ The acceptance by any individual of fam- ily planning services or family planning or population
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p.001243: January 30, 2020
p.001243: (ii) the average annual level of State fiscal ex- penditures for the services and activities described
p.001243: in paragraphs (1) and (2) of section 1501(a) for the year preceding the first year for which the waiver
p.001243: was granted.
p.001243: (4) LIMITATION.—Amounts to which a waiver applies under this subsection shall not be used to increase the number of
p.001243: sal- aried employees.
p.001243: (5) DEFINITIONS.—In this subsection:
p.001243: (A) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the meaning given the term in section 4 of the Indian
p.001243: Health Care Improvement Act (25 U.S.C. 1603).
p.001243: (B) TRIBAL ORGANIZATION.—The term ‘‘tribal organiza- tion’’ has the meaning given the term in section 4 of
p.001243: the Indian Health Care Improvement Act.
p.001243: (C) STATE.—The term ‘‘State’’ means each of the sev- eral States of the United States, the District of
p.001243: Columbia, the Commonwealth of Puerto Rico, American Samoa, the Commonwealth of the Northern Mariana
p.001243: Islands, the Re- public of the Marshall Islands, the Federated States of Mi- cronesia, the Republic of Palau, an
p.001243: Indian tribe, and a tribal organization.
p.001243: (6) SUNSET.—The Secretary may not grant a waiver or ex- tension under this subsection after September 30, 2012.
p.001243: SEC. 1504. ø300n¿ ADDITIONAL REQUIRED AGREEMENTS.
p.001243: (a) PRIORITY FOR LOW-INCOME WOMEN.—The Secretary may not make a grant under section 1501 unless the
p.001243: State involved agrees that low-income women will be given priority in the provi- sion of services and
p.001243: activities pursuant to paragraphs (1) and (2) of section 1501(a).
p.001243: (b) LIMITATION ON IMPOSITION OF FEES FOR SERVICES.—The Secretary may not make a grant under section
p.001243: 1501 unless the State involved agrees that, if a charge is imposed for the provision of services or activities under
p.001243: the grant, such charge—
p.001243: (1) will be made according to a schedule of charges that is made available to the public;
p.001243: (2) will be adjusted to reflect the income of the woman in- volved; and
p.001243: (3) will not be imposed on any woman with an income of less than 100 percent of the official poverty line,
p.001243: as established by the Director of the Office of Management and Budget and revised by the Secretary in
p.001243: accordance with section 673(2) of the Omnibus Budget Reconciliation Act of 1981.
p.001243: (c) STATEWIDE PROVISION OF SERVICES.—
p.001243: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001243:
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p.001243: Sec. 1504 PUBLIC HEALTH SERVICE ACT 1244
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p.001253: building, or life safety codes or regulations, or
p.001253: (ii) avoid noncompliance by medical facilities with State or voluntary licensure or accreditation standards.
p.001253: (B) A grant under subparagraph (A) may only be made to—
p.001253: (i) a State or political subdivision of a State, including any city, town, county, borough, hospital district
p.001253: authority, or pub- lic or quasi-public corporation, for any medical facility owned or operated by the State or
p.001253: political subdivision; and
p.001253: (ii) a nonprofit private entity for any medical facility owned or operated by the entity but only if
p.001253: the Secretary deter- mines—
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p.001253: (I) the level of community service provided by the fa- cility and the proportion of its patients who are
p.001253: unable to pay for services rendered in the facility is similar to such level and proportion in a medical
p.001253: facility of a State or po- litical subdivision, and
p.001253: (II) that without a grant under subparagraph (A) there would be a disruption of the provision of health
p.001253: care to low-income individuals.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 75 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
p.001253: rural poverty area, in which case the grant may cover up to 100 per centum of such costs.
p.001253: (3) There are authorized to be appropriated for grants under paragraph (1) $40,000,000 for the fiscal year
p.001253: ending September 30, 1980, $50,000,000 for the fiscal year ending September 30, 1981, and $50,000,000 for
p.001253: the fiscal year ending September 30, 1982. Funds available for obligation under this subsection (as in
p.001253: effect before the date of the enactment of the Health Planning and Re- sources Development Amendments of
p.001253: 1979) in the fiscal year end- ing September 30, 1979, shall remain available for obligation under this subsection
p.001253: in the succeeding fiscal year.
p.001253: (b)(1) The Secretary may make grants to public and nonprofit private entities for projects for (A)
p.001253: construction or modernization of outpatient medical facilities which are located apart from hospitals and which will
p.001253: provide services for medically underserved popu- lations, and (B) conversion of existing facilities into
p.001253: outpatient medical facilities or facilities for long-term care to provide services for such populations.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 80 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
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p.001345: guardians of the unemancipated minor refuse to make such payments.
p.001345: PRIORITIES, AMOUNTS, AND DURATION OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2005. ø300z–4¿ (a) In approving applications for grants for demonstration projects for services under
p.001345: this title, the Sec- retary shall give priority to applicants who—
p.001345: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001347: 1347
p.001347: PUBLIC HEALTH SERVICE ACT
p.001347: Sec. 2005
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p.001347: (1) serve an area where there is a high incidence of adoles- cent pregnancy;
p.001347: (2) serve an area with a high proportion of low-income families and where the availability of programs
p.001347: of care for pregnant adolescents and adolescent parents is low;
p.001347: (3) show evidence—
p.001347: (A) in the case of an applicant who will provide care services, of having the ability to bring
p.001347: together a wide range of needed core services and, as appropriate, supple- mental services in comprehensive
p.001347: single-site projects, or to establish a well-integrated network of such services (ap- propriate for the target
p.001347: population and geographic area to be served including the special needs of rural areas) for pregnant
p.001347: adolescents or adolescent parents; or
p.001347: (B) in the case of an applicant who will provide pre- vention services, of having the ability to
p.001347: provide preven- tion services for adolescents and their families which are appropriate for the target
p.001347: population and the geographic area to be served, including the special needs of rural areas;
p.001347: (4) will utilize to the maximum extent feasible existing available programs and facilities such as neighborhood
p.001347: and pri- mary health care centers, maternity homes which provide or can be equipped to provide services
p.001347: to pregnant adolescents, agencies serving families, youth, and children with established programs of service to
...

p.001459:
p.001459: Sec. 2604 PUBLIC HEALTH SERVICE ACT 1460
p.001459:
p.001459: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001459: this title.
p.001459: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing the chief elected official of an eligible area that a grant
p.001459: under section 2601 is being made for the area for a grant year, the Secretary shall inform the
p.001459: official whether a waiver under subparagraph (A) is in effect for such year.
p.001459: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001459: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual), means the following
p.001459: services:
p.001459: (A) Outpatient and ambulatory health services.
p.001459: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001459: (C) AIDS pharmaceutical assistance.
p.001459: (D) Oral health care.
p.001459: (E) Early intervention services described in subsection
p.001459: (e).
p.001459: (F) Health insurance premium and cost sharing assist-
p.001459:
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p.001459:
p.001459:
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p.001459:
p.001459:
p.001459:
p.001459: January 30, 2020
p.001459: ance for low-income individuals in accordance with section 2615.
p.001459: (G) Home health care.
p.001459: (H) Medical nutrition therapy.
p.001459: (I) Hospice services.
p.001459: (J) Home and community-based health services as de- fined under section 2614(c).
p.001459: (K) Mental health services.
p.001459: (L) Substance abuse outpatient care.
p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
...

p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
p.001463: or
p.001463: (B) by an entity that provides health services on a pre- paid basis;
p.001463: (7) to the maximum extent practicable, that—
p.001463: (A) HIV health care and support services provided with assistance made available under this subpart will be
p.001463: provided without regard—
p.001463: (i) to the ability of the individual to pay for such services; and
p.001463: (ii) to the current or past health condition of the individual to be served;
p.001463: (B) such services will be provided in a setting that is accessible to low-income individuals with
p.001463: HIV-disease; and
p.001463: (C) a program of outreach will be provided to low-in- come individuals with HIV-disease to inform such
p.001463: individ- uals of such services;
p.001463: (8) that the applicant has participated, or will agree to participate, in the statewide coordinated
p.001463: statement of need process where it has been initiated by the State public health
p.001463: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001463:
p.001463:
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p.001465: 1465
p.001465: PUBLIC HEALTH SERVICE ACT
p.001465: Sec. 2605
p.001465:
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p.001465:
p.001465: January 30, 2020
p.001465: agency responsible for administering grants under part B, and ensure that the services provided under the
p.001465: comprehensive plan are consistent with the statewide coordinated statement of need;
...

p.001473: (2) WAIVER.—
p.001473: (A) IN GENERAL.—The Secretary shall waive the appli- cation of paragraph (1) with respect to a State for a grant year
p.001473: if the Secretary determines that, within the State—
p.001473: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001473: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001473: this title.
p.001473: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing a State that a grant under section 2611 is being made to
p.001473: the State for a fiscal year, the Secretary shall inform the State whether a waiver under subparagraph
p.001473: (A) is in effect for the fiscal year.
p.001473: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001473: to an in- dividual infected with HIV/AIDS (including the co-occurring conditions of the individual) means the
p.001473: following services:
p.001473: (A) Outpatient and ambulatory health services.
p.001473: (B) AIDS Drug Assistance Program treatments in ac- cordance with section 2616.
p.001473: (C) AIDS pharmaceutical assistance.
p.001473: (D) Oral health care.
p.001473: (E) Early intervention services described in subsection
p.001473: (d).
p.001473: (F) Health insurance premium and cost sharing assist-
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473:
p.001473: January 30, 2020
p.001473: ance for low-income individuals in accordance with section 2615.
p.001473: (G) Home health care.
p.001473: (H) Medical nutrition therapy.
p.001473: (I) Hospice services.
p.001473: (J) Home and community-based health services as de- fined under section 2614(c).
p.001473: (K) Mental health services.
p.001473: (L) Substance abuse outpatient care.
p.001473: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001473:
p.001473:
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p.001473: Sec. 2612 PUBLIC HEALTH SERVICE ACT 1474
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p.001473: January 30, 2020
p.001473:
p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
...

p.001477: SEC. 2614. ø300ff–24¿ GRANTS FOR HOME- AND COMMUNITY-BASED CARE.
p.001477: (a) USES.—A State may use amounts provided under a grant awarded under section 2611 to make grants
p.001477: under section 2612(b)(3)(J) to entities to—
p.001477: (1) provide home- and community-based health services for individuals with HIV/AIDS pursuant to written plans of
p.001477: care prepared by a case management team, that shall include ap- propriate health care professionals, in such
p.001477: State for providing such services to such individuals;
p.001477: (2) provide outreach services to individuals with HIV/ AIDS, including those individuals in rural areas;
p.001477: and
p.001477: (3) provide for the coordination of the provision of services under this section with the provision of
p.001477: HIV-related health services, including specialty care and vaccinations for hepatitis co-infection, provided by public
p.001477: and private entities.
p.001477: (b) PRIORITY.—In awarding grants under subsection (a), a State shall give priority to entities that
p.001477: provide assurances to the State that—
p.001477: (1) such entities will participate in HIV care consortia if such consortia exist within the State; and
p.001477: (2) such entities will utilize amounts provided under such grants for the provision of home- and
p.001477: community-based serv- ices to low-income individuals with HIV/AIDS.
p.001477: (c) DEFINITION.—As used in section 2611, the term ‘‘home- and community-based health services’’—
p.001477: (1) means, with respect to an individual with HIV/AIDS, skilled health services furnished to the
p.001477: individual in the indi- vidual’s home pursuant to a written plan of care established by a case management team, that
p.001477: shall include appropriate health care professionals, for the provision of such services and items described in
p.001477: paragraph (2);
p.001477: (2) includes—
p.001477: (A) durable medical equipment;
p.001477: (B) home health aide services and personal care serv- ices furnished in the home of the individual;
p.001477: (C) day treatment or other partial hospitalization serv- ices;
p.001477: (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such
p.001477: therapy);
p.001477: (E) routine diagnostic testing administered in the home of the individual; and
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001477:
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p.001479: 1479
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p.001479: HIV/AIDS in—
p.001479: (1) maintaining a continuity of health insurance; or
p.001479: (2) receiving medical benefits under a health insurance program, including risk-pools.
p.001479: (b) LIMITATIONS.—Assistance shall not be utilized under sub- section (a)—
p.001479: (1) to pay any costs associated with the creation, capital- ization, or administration of a liability
p.001479: risk pool (other than those costs paid on behalf of individuals as part of premium contributions to
p.001479: existing liability risk pools); and
p.001479: (2) to pay any amount expended by a State under title XIX of the Social Security Act.
p.001479: SEC. 2616. ø300ff–26¿ PROVISION OF TREATMENTS.
p.001479: (a) IN GENERAL.—A State shall use a portion of the amounts provided under a grant awarded under section 2611
p.001479: to establish a program under section 2612(b)(3)(B) to provide therapeutics to treat HIV/AIDS or prevent the
p.001479: serious deterioration of health aris- ing from HIV/AIDS in eligible individuals, including measures for the
p.001479: prevention and treatment of opportunistic infections.
p.001479: (b) ELIGIBLE INDIVIDUAL.—To be eligible to receive assistance from a State under this section an individual
p.001479: shall—
p.001479: (1) have a medical diagnosis of HIV/AIDS; and
p.001479: (2) be a low-income individual, as defined by the State.
p.001479: (c) STATE DUTIES.—In carrying out this section the State shall—
p.001479:
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p.001479:
p.001479: January 30, 2020
p.001479: (1) ensure that the therapeutics included on the list of classes of core antiretroviral therapeutics
p.001479: established by the Secretary under subsection (e) are, at a minimum, the treat- ments provided by the State
p.001479: pursuant to this section;
p.001479: (2) provide assistance for the purchase of treatments deter- mined to be eligible under paragraph (1), and the
p.001479: provision of such ancillary devices that are essential to administer such treatments;
p.001479: (3) provide outreach to individuals with HIV/AIDS, and as appropriate to the families of such individuals;
p.001479: (4) facilitate access to treatments for such individuals;
p.001479: (5) document the progress made in making therapeutics described in subsection (a) available to individuals
p.001479: eligible for assistance under this section; and
p.001479: (6) encourage, support, and enhance adherence to and com- pliance with treatment regimens, including related
p.001479: medical monitoring.
p.001479: Of the amount reserved by a State for a fiscal year for use under this section, the State may not
p.001479: use more than 5 percent to carry
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001479:
p.001479:
p.001479:
p.001479:
p.001479:
p.001479:
...

p.001483: and
p.001483: (6) an assurance that the public health agency admin- istering the grant for the State will periodically
p.001483: convene a meeting of individuals with HIV/AIDS, members of a Federally recognized Indian tribe as represented in the
p.001483: State, represent- atives of grantees under each part under this title, providers, and public agency
p.001483: representatives for the purpose of developing a statewide coordinated statement of need;
p.001483: (7) an assurance by the State that—
p.001483: (A) the public health agency that is administering the grant for the State engages in a public advisory
p.001483: planning process, including public hearings, that includes the par- ticipants under paragraph (6), and the types
p.001483: of entities de- scribed in section 2602(b)(2), in developing the comprehen- sive plan under paragraph (5) and
p.001483: commenting on the im- plementation of such plan;
p.001483: (B) the State will—
p.001483: (i) to the maximum extent practicable, ensure that HIV-related health care and support services delivered pursuant to
p.001483: a program established with assistance provided under section 2611 will be provided without regard to the
p.001483: ability of the individual to pay for such services and without regard to the current or past health
p.001483: condition of the individual with HIV/AIDS;
p.001483: (ii) ensure that such services will be provided in a setting that is accessible to low-income
p.001483: individuals with HIV/AIDS;
p.001483: (iii) provide outreach to low-income individuals with HIV/AIDS to inform such individuals of the serv- ices
p.001483: available under section 2611; and
p.001483: (iv) in the case of a State that intends to use amounts provided under the grant for purposes de-
p.001483: scribed in 2615 8, submit a plan to the Secretary that demonstrates that the State has established a
p.001483: pro- gram that assures that—
p.001483: (I) such amounts will be targeted to individ- uals who would not otherwise be able to afford health
p.001483: insurance coverage; and
p.001483: (II) income, asset, and medical expense cri- teria will be established and applied by the State to
p.001483: identify those individuals who qualify for assist- ance under such program, and information con- cerning such
p.001483: criteria shall be made available to the public;
p.001483: (C) the State will provide for periodic independent peer review to assess the quality and appropriateness
p.001483: of
p.001483:
p.001483:
p.001483:
p.001483:
p.001483:
p.001483:
p.001483: January 30, 2020
p.001483: 8 The word ‘‘section’’ probably should appear before ‘‘2615’’. Section 12(c)(3) of Public Law 104– 146 (110 Stat. 1373)
p.001483: provides that subsection (b)(3)(B)(iv) is amended by inserting ‘‘section’’ be- fore ‘‘2615’’, but the amendment
p.001483: cannot be executed because the term ‘‘2615’’ does not appear in paragraph (3)(B)(iv). The term formerly did
p.001483: appear in such paragraph, but former paragraph
p.001483: (3) was redesignated as paragraph (4) by section 3(c)(4)(B) of such Public Law (110 Stat. 1355).
p.001483: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001483:
p.001483:
p.001483:
p.001483:
p.001483:
p.001483:
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p.001507: (i) there are no waiting lists for AIDS Drug Assist- ance Program services under section 2616; and
p.001507: (ii) core medical services are available to all indi- viduals with HIV/AIDS identified and eligible under
p.001507: this title.
p.001507: (B) NOTIFICATION OF WAIVER STATUS.—When inform- ing an applicant that a grant under subsection (a) is being
p.001507: made for a fiscal year, the Secretary shall inform the ap- plicant whether a waiver under subparagraph (A) is
p.001507: in ef- fect for the fiscal year.
p.001507: (3) CORE MEDICAL SERVICES.—For purposes of this sub- section, the term ‘‘core medical services’’, with respect
p.001507: to an in- dividual with HIV/AIDS (including the co-occurring conditions of the individual) means the following
p.001507: services:
p.001507: (A) Outpatient and ambulatory health services.
p.001507: (B) AIDS Drug Assistance Program treatments under section 2616.
p.001507: (C) AIDS pharmaceutical assistance.
p.001507: (D) Oral health care.
p.001507: (E) Early intervention services described in subsection
p.001507: (e).
p.001507: (F) Health insurance premium and cost sharing assist-
p.001507:
p.001507:
p.001507:
p.001507:
p.001507:
p.001507:
p.001507:
p.001507:
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p.001507:
p.001507:
p.001507:
p.001507:
p.001507: January 30, 2020
p.001507: ance for low-income individuals in accordance with section 2615.
p.001507: (G) Home health care.
p.001507: (H) Medical nutrition therapy.
p.001507: (I) Hospice services.
p.001507: (J) Home and community-based health services as de- fined under section 2614(c).
p.001507: (K) Mental health services.
p.001507: (L) Substance abuse outpatient care.
p.001507: (M) Medical case management, including treatment adherence services.
p.001507: (d) SUPPORT SERVICES.—
p.001507: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001507: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001507: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001507: transportation, linguistic services, and referrals for health care and support services).
p.001507: (2) DEFINITION OF MEDICAL OUTCOMES.—In this section, the term ‘‘medical outcomes’’ means those outcomes
p.001507: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001507: (e) SPECIFICATION OF EARLY INTERVENTION SERVICES.—
p.001507: (1) IN GENERAL.—The early intervention services referred to in this section are—
...

p.001509: Sec. 2652
p.001509:
p.001509: (A) federally-qualified health centers under section 1905(l)(2)(B) of the Social Security Act;
p.001509: (B) grantees under section 1001 (regarding family planning) other than States;
p.001509: (C) comprehensive hemophilia diagnostic and treat- ment centers;
p.001509: (D) rural health clinics;
p.001509: (E) health facilities operated by or pursuant to a con- tract with the Indian Health Service;
p.001509: (F) community-based organizations, clinics, hospitals and other health facilities that provide early
p.001509: intervention services to those persons infected with HIV/AIDS through intravenous drug use; or
p.001509: (G) nonprofit private entities that provide comprehen- sive primary care services to populations at risk of
p.001509: HIV/ AIDS, including faith-based and community-based organi- zations.
p.001509: (2) UNDERSERVED POPULATIONS.—Entities described in paragraph (1) shall serve underserved populations
p.001509: which may include minority populations and Native American populations, ex-offenders, individuals with comorbidities
p.001509: including hepatitis B or C, mental illness, or substance abuse, low-income popu- lations, inner city
p.001509: populations, and rural populations. 13;
p.001509: (b) STATUS AS MEDICAID PROVIDER.—
p.001509: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under section 2651 for the
p.001509: provision of services described in subsection (b) of such section in a State unless, in the case of any
p.001509: such service that is available pursu- ant to the State plan approved under title XIX of the Social Se- curity Act for
p.001509: the State—
p.001509: (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation
p.001509: agreement under the State plan and is qualified to receive payments under such plan; or
p.001509: (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity,
p.001509: or a private for-profit entity if such entity is the only available provider of quality HIV care in the area, under
p.001509: which the entity will provide the service, and the entity has entered into such a participation agreement and
p.001509: is qualified to re- ceive such payments.
p.001509: (2) WAIVER REGARDING CERTAIN SECONDARY AGREE- MENTS.—
p.001509: (A) In the case of an entity making an agreement pur- suant to paragraph (1)(B) regarding the provision of
p.001509: serv- ices, the requirement established in such paragraph re- garding a participation agreement shall be
p.001509: waived by the Secretary if the entity does not, in providing health care services, impose a charge or
p.001509: accept reimbursement avail- able from any third-party payor, including reimbursement under any insurance
...

p.001509: (a) SERVICES FOR INDIVIDUALS WITH HEMOPHILIA.—In making grants under section 2651, the Secretary shall
p.001509: ensure that any such grants made regarding the provision of early intervention services to individuals with
p.001509: hemophilia are made through the net- work of comprehensive hemophilia diagnostic and treatment cen- ters.
p.001509: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001509:
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p.001511: 1511
p.001511: PUBLIC HEALTH SERVICE ACT
p.001511: Sec. 2655
p.001511:
p.001511: (b) TECHNICAL ASSISTANCE.—The Secretary may, directly or through grants or contracts, provide technical
p.001511: assistance to non- profit private entities regarding the process of submitting to the Secretary applications
p.001511: for grants under section 2651, and may pro- vide technical assistance with respect to the planning, develop-
p.001511: ment, and operation of any program or service carried out pursuant to such section.
p.001511: (c) PLANNING AND DEVELOPMENT GRANTS.—
p.001511: (1) IN GENERAL.—The Secretary may provide planning grants to public and nonprofit private entities for
p.001511: purposes of—
p.001511: (A) enabling such entities to provide early intervention services; and
p.001511: (B) assisting the entities in expanding their capacity to provide HIV/AIDS-related health services,
p.001511: including early intervention services, in low-income communities and affected subpopulations that are underserved
p.001511: with respect to such services (subject to the condition that a grant pur- suant to this subparagraph may not be
p.001511: expended to pur- chase or improve land, or to purchase, construct, or perma- nently improve, other than minor
p.001511: remodeling, any building or other facility).
p.001511: (2) REQUIREMENT.—The Secretary may only award a grant to an entity under paragraph (1) if the Secretary
p.001511: determines that the entity will use such grant to assist the entity in quali- fying for a grant under section 2651.
p.001511: (3) PREFERENCE.—In awarding grants under paragraph (1), the Secretary shall give preference to entities that
p.001511: provide primary care services in rural areas or to underserved popu- lations.
p.001511: (4) AMOUNT AND DURATION OF GRANTS.—
p.001511: (A) EARLY INTERVENTION SERVICES.—A grant under paragraph (1)(A) may be made in an amount not to exceed
p.001511: $50,000.
p.001511: (B) CAPACITY DEVELOPMENT.—
p.001511: (i) AMOUNT.—A grant under paragraph (1)(B) may be made in an amount not to exceed $150,000.
p.001511: (ii) DURATION.—The total duration of a grant under paragraph (1)(B), including any renewal, may not
p.001511: exceed 3 years.
p.001511: (5) LIMITATION.—Not to exceed 5 percent of the amount appropriated for a fiscal year under section 2655 may be
p.001511: used to carry out this section.
p.001511: SEC. 2655. ø300ff–55¿ AUTHORIZATION OF APPROPRIATIONS.
p.001511: For the purpose of making grants under section 2651, there are authorized to be appropriated,
p.001511: $218,600,000 for fiscal year 2007, $226,700,000 for fiscal year 2008, $235,100,000 for fiscal year 2009,
...

p.001603: (3) SPECIAL RULE FOR POOLS CHARGING HIGHER PRE- MIUMS.—In the case of a qualified high risk
p.001603: pool of a State which charges premiums that exceed 150 percent of the pre- mium for applicable standard
p.001603: risks, the State shall use at least 50 percent of the amount of the grant provided to the State to carry out this
p.001603: subsection to reduce premiums for enrollees.
p.001603: (4) LIMITATION FOR TERRITORIES.—In no case shall the ag- gregate amount allotted and made available under
p.001603: paragraph
p.001603: (2) for a fiscal year to States that are not the 50 States or the District of Columbia exceed $1,000,000.
p.001603: (c) BONUS GRANTS FOR SUPPLEMENTAL CONSUMER BENEFITS.—
p.001603: (1) IN GENERAL.—In the case of a State that is one of the 50 States or the District of Columbia,
p.001603: that has established a qualified high risk pool, and that is receiving a grant under subsection (b)(1),
p.001603: the Secretary shall provide, from the funds appropriated under paragraphs (1)(B)(ii) and (2)(B) of sub-
p.001603: section (d) and allotted to the State under paragraph (3), a grant to be used to provide supplemental
p.001603: consumer benefits to enrollees or potential enrollees (or defined subsets of such en- rollees or potential
p.001603: enrollees) in qualified high risk pools.
p.001603: (2) BENEFITS.—A State shall use amounts received under a grant under this subsection to provide one or more of
p.001603: the fol- lowing benefits:
p.001603: (A) Low-income premium subsidies.
p.001603: (B) A reduction in premium trends, actual premiums, or other cost-sharing requirements.
p.001603: (C) An expansion or broadening of the pool of individ- uals eligible for coverage, such as through eliminating
p.001603: waiting lists, increasing enrollment caps, or providing flexibility in enrollment rules.
p.001603: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001603:
p.001603:
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p.001603:
p.001603:
p.001605: 1605
p.001605: PUBLIC HEALTH SERVICE ACT
p.001605: Sec. 2745
p.001605:
p.001605: (D) Less stringent rules, or additional waiver author- ity, with respect to coverage of pre-existing conditions.
p.001605: (E) Increased benefits.
p.001605: (F) The establishment of disease management pro- grams.
p.001605: (3) ALLOTMENT; LIMITATION.—The Secretary shall allot funds appropriated under paragraphs (1)(B)(ii) and
p.001605: (2)(B) of subsection (d) among States qualifying for a grant under para- graph (1) in a manner specified by the
p.001605: Secretary, but in no case shall the amount so allotted to a State for a fiscal year exceed 10 percent
p.001605: of the funds so appropriated for the fiscal year.
p.001605: (4) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to prohibit a State that, on the
p.001605: date of the enactment of the State High Risk Pool Funding Extension Act of 2006, is in the process of implementing a
...

Economic / investors/intellectual rights

Searching for indicator investors:

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p.000239:
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p.000239:
p.000239: January 30, 2020
p.000239: (I) foster and accelerate the development and innovation of medical countermeasures and tech- nologies that
p.000239: may assist advanced research and the development of qualified countermeasures and qualified pandemic or
p.000239: epidemic products, includ- ing through the use of strategic venture capital practices and methods;
p.000239: (II) promote the development of new and promising technologies that address urgent med- ical
p.000239: countermeasure needs, as identified by the Secretary;
p.000239: (III) address unmet public health needs that are directly related to medical countermeasure re- quirements,
p.000239: such as novel antimicrobials for multidrug resistant organisms and multiuse plat- form technologies for
p.000239: diagnostics, prophylaxis, vac- cines, and therapeutics; and
p.000239: (IV) provide expert consultation and advice to foster viable medical countermeasure innovators, including
p.000239: helping qualified countermeasure innovators navigate unique industry challenges with respect to
p.000239: developing chemical, biological, ra- diological, and nuclear countermeasure products.
p.000239: (ii) ELIGIBILITY.—
p.000239: (I) IN GENERAL.—To be eligible to enter into an agreement under clause (i) an entity shall—
p.000239: (aa) be an independent, nonprofit entity; (bb) have a demonstrated record of being able to create
p.000239: linkages between innovators and investors and leverage such partnerships and resources for the purpose of
p.000239: addressing identified strategic needs of the Federal Gov-
p.000239: ernment;
p.000239: (cc) have experience in promoting novel technology innovation;
p.000239: (dd) be problem-driven and solution-fo- cused based on the needs, requirements, and problems identified
p.000239: by the Secretary under clause (iv);
p.000239: (ee) demonstrate the ability, or the poten- tial ability, to promote the development of medical countermeasure
p.000239: products;
p.000239: (ff) demonstrate expertise, or the capacity to develop or acquire expertise, related to
p.000239: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000239:
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p.000239:
p.000239: Sec. 319L PUBLIC HEALTH SERVICE ACT 240
p.000239:
p.000239: technical and regulatory considerations with respect to medical countermeasures; and
p.000239: (gg) not be within the Department of Health and Human Services.
p.000239: (II) PARTNERING EXPERIENCE.—In selecting an entity with which to enter into an agreement under clause
p.000239: (i), the Secretary shall place a high value on the demonstrated experience of the enti- ty in partnering with
p.000239: the Federal Government to meet identified strategic needs.
p.000239: (iii) NOT AGENCY.—An entity that enters into an agreement under clause (i) shall not be deemed to be a
...

General/Other / Dependent

Searching for indicator dependent:

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p.000001:
p.000001: tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code);
p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
p.000001: TITLE II—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
p.000001: PART A—ADMINISTRATION
p.000001: PUBLIC HEALTH SERVICE
p.000001: SEC. 201. ø202¿ The Public Health Service in the Department of Health and Human Services shall be administered by the
p.000001: Assist- ant Secretary for Health under the supervision and direction of the Secretary.
p.000001: ORGANIZATION
p.000001: SEC. 202. 1 ø203¿ The Service shall consist of (1) the Office of the Surgeon General, (2) the National
p.000001: Institutes of Health, (3) the
p.000001:
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p.000001: January 30, 2020
p.000001: 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were
p.000001: all abolished as statutory entities by Reorganization Plan No. 3 of 1966. Although the Reorganization Plan
p.000001: abolished the National Institutes of Health as an agency, it did not abolish the individual research
...

p.000001: (6) Chapter 75, Death Benefits.
p.000001: (7) Section 2771, Final settlement of accounts: deceased members.
p.000001: (8) Chapter 163, Military Claims, but only when commis- sioned officers of the Service are entitled to
p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
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p.000255: EXAMINATION OF ALIENS
p.000255: SEC. 325. ø252¿ The Surgeon General shall provide for mak- ing, at places within the United States or
p.000255: in other countries, such physical and mental examinations of aliens as are required by the immigration laws,
p.000255: subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the
p.000255: Surgeon General with the approval of the Secretary.
p.000255: SERVICES TO COAST GUARD, COAST AND GEODETIC SURVEY, AND PUBLIC HEALTH SERVICE
p.000255: SEC. 326. ø253¿ (a) Subject to regulations of the President—
p.000255: (1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the
p.000255: Regular Coast Guard on active duty, including those on shore duty and those on detached duty; and Regular and
p.000255: temporary members of the United States Coast Guard Reserve when on active duty;
p.000255: (2) commissioned officers, ships’ officers, and members of the crews of vessels of the United States
p.000255: Coast and Geodetic Survey on active duty including those on shore duty and those on detached duty; and
p.000255: (3) commissioned officers of the Regular or Reserve Corps of the Public Health Service on active duty;
p.000255: shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service. The
p.000255: Surgeon General may detail commissioned officers for duty aboard vessels of the Coast Guard or the Coast
p.000255: and Geodetic Survey.
p.000255: (b)(1) The Secretary may provide health care for an officer of the Regular or Reserve Corps
p.000255: involuntarily separated from the Service, and for any dependent of such officer, if—
p.000255: (A) the officer or dependent was receiving health care at the expense of the Service at the time of
p.000255: the separation; and
p.000255: (B) the Secretary finds that the officer or dependent is un- able to obtain appropriate insurance for the
p.000255: conditions for which the officer or dependent was receiving health care.
p.000255: (2) Health care may be provided under paragraph (1) for a pe- riod of not more than one year from the date of
p.000255: separation of the officer from the Service.
p.000255: (c) The Service shall provide all services referred to in sub- section (a) required by the Coast Guard or
p.000255: Coast and Geodetic Sur- vey and shall perform all duties prescribed by statute in connection with the examinations
p.000255: to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, pro-
p.000255: motion and retirement, and officers of the Service assigned to duty on Coast Guard or Coast and Geodetic Survey
p.000255: vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
p.000255:
p.000255: January 30, 2020 As Amended Through P.L. 116-94,
p.000255: Enacted December 20, 2019
p.000255:
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p.000257: 257
p.000257: PUBLIC HEALTH SERVICE ACT
p.000257: Sec. 330
p.000257:
p.000257: INTERDEPARTMENTAL WORK
p.000257: SEC. 327. ø254¿ Nothing contained in this part shall affect the authority of the Service to furnish any
p.000257: materials, supplies, or equipment, or perform any work or services, requested in accord- ance with section 7
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p.000275: (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban
p.000275: areas;
p.000275: (D) the distribution of awards and funding for estab- lishing new access points, and the number of new
p.000275: access points created;
p.000275: (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI;
p.000275: (F) the rationale for any substantial changes in the distribution of funds;
p.000275: (G) the rate of closures for health centers and access points;
p.000275: (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and
p.000275: (I) the number and reason for any waivers provided pursuant to subsection (q)(4).
p.000275: (4) RULE OF CONSTRUCTION WITH RESPECT TO RURAL HEALTH CLINICS.—
p.000275: (A) IN GENERAL.—Nothing in this section shall be con- strued to prevent a community health center from con-
p.000275: tracting with a Federally certified rural health clinic (as defined in section 1861(aa)(2) of the Social
p.000275: Security Act), a low-volume hospital (as defined for purposes of section 1886 of such Act), a critical access
p.000275: hospital, a sole commu- nity hospital (as defined for purposes of section 1886(d)(5)(D)(iii) of
p.000275: such Act), or a medicare-dependent share hospital (as defined for purposes of section
p.000275: 1886(d)(5)(G)(iv) of such Act) for the delivery of primary health care services that are available at the
p.000275: clinic or hos- pital to individuals who would otherwise be eligible for free or reduced cost care if that
p.000275: individual were able to ob-
p.000275: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000275:
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p.000275: Sec. 330A PUBLIC HEALTH SERVICE ACT 276
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p.000275: January 30, 2020
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p.000275: tain that care at the community health center. Such serv- ices may be limited in scope to those primary health
p.000275: care services available in that clinic or hospitals.
p.000275: (B) ASSURANCES.—In order for a clinic or hospital to receive funds under this section through a contract with a
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p.000521: (B) strategies to educate school-age children, including pregnant and high risk youth, concerning Fetal Alcohol
p.000521: Syndrome and Fetal Alcohol Effect;
p.000521: (C) public and community awareness programs con- cerning Fetal Alcohol Syndrome and Fetal Alcohol Effect;
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p.000521: January 30, 2020
p.000521: (D) strategies to coordinate information and services across affected community agencies, including
p.000521: agencies providing social services such as foster care, adoption, and social work, medical and mental health services,
p.000521: and agen- cies involved in education, vocational training and civil and criminal justice;
p.000521: (2) a prevention and diagnosis program to support clinical studies, demonstrations and other research as appropriate
p.000521: to—
p.000521: (A) develop appropriate medical diagnostic methods for identifying Fetal Alcohol Syndrome and Fetal Alcohol Ef-
p.000521: fect; and
p.000521: (B) develop effective prevention services and interven- tions for pregnant, alcohol-dependent women; and
p.000521: (3) an applied research program concerning intervention and prevention to support and conduct service
p.000521: demonstration projects, clinical studies and other research models providing advocacy, educational and
p.000521: vocational training, counseling, med- ical and mental health, and other supportive services, as well as models
p.000521: that integrate and coordinate such services, that are aimed at the unique challenges facing individuals with
p.000521: Fetal Alcohol Syndrome or Fetal Alcohol Effect and their families.
p.000521: (b) GRANTS AND TECHNICAL ASSISTANCE.—The Secretary may award grants, cooperative agreements and contracts
p.000521: and provide
p.000521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000523: PUBLIC HEALTH SERVICE ACT
p.000523: Sec. 399H
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p.001309: abuse by the individuals;
p.001309: (2) will, in carrying out paragraph (1)—
p.001309: (A) give priority to programs for populations that are at risk of developing a pattern of such abuse; and
p.001309: (B) ensure that programs receiving priority under sub- paragraph (A) develop community-based strategies for the
p.001309: prevention of such abuse, including strategies to discour- age the use of alcoholic beverages and tobacco
p.001309: products by individuals to whom it is unlawful to sell or distribute such beverages or products.
p.001309: (b) 5 ALLOCATIONS REGARDING WOMEN.—
p.001309: (1) IN GENERAL.—Subject to paragraph (2), a funding agreement for a grant under section 1921 for
p.001309: a fiscal year is that—
p.001309: (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5
p.001309: percent of the grant to increase (relative to fiscal year 1992) the avail- ability of treatment services
p.001309: designed for pregnant women and women with dependent children (either by estab- lishing new programs or
p.001309: expanding the capacity of existing programs);
p.001309: (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of
p.001309: the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and
p.001309: (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services
p.001309: for such women not less than an amount equal to the amount ex- pended by the State for fiscal year 1994.
p.001309: (2) WAIVER.—
p.001309: (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the
p.001309: require- ment established in paragraph (1) if the Secretary deter- mines that the State is providing an
p.001309: adequate level of treatments services for women described in such para-
p.001309:
p.001309: 5 Paragraph (2)(A) of section 3303(f) of Public Law 106–310 (114 Stat. 1211) provides as fol- lows:
p.001309: (2) CONFORMING AMENDMENTS.—Effective upon the publication of the regulations devel- oped in accordance with
p.001309: section 1932(e)(1) of the Public Health Service Act (42 U.S.C. 300x– 32(d))—
p.001309: (A) section 1922(c) of the Public Health Service Act (42 U.S.C. 300x–22(c)) is amended by—
p.001309:
p.001309:
p.001309:
p.001309:
p.001309: January 30, 2020
p.001309: (i) striking paragraph (2); and
p.001309: (ii) redesignating paragraph (3) as paragraph (2); and
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p.001321: provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent
p.001321: fiscal year for which the State received a grant under section 1921; and
p.001321: (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such
p.001321: manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary
p.001321: to carry out this subpart.
p.001321: (b) STATE PLAN.—
p.001321: (1) IN GENERAL.—In order for a State to be in compliance with subsection (a)(6), the State shall submit
p.001321: to the Secretary a plan that, at a minimum, includes the following:
p.001321: (A) A description of the State’s system of care that—
p.001321: (i) identifies the single State agency responsible for the administration of the program, including any
p.001321: third party who administers substance use disorder services and is responsible for complying with the re-
p.001321: quirements of the grant;
p.001321: (ii) provides information on the need for substance use disorder prevention and treatment services in the State,
p.001321: including estimates on the number of individ- uals who need treatment, who are pregnant women, women with
p.001321: dependent children, individuals with a co- occurring mental health and substance use disorder, persons who inject
p.001321: drugs, and persons who are experi- encing homelessness;
p.001321: (iii) provides aggregate information on the number of individuals in treatment within the State, including the number
p.001321: of such individuals who are pregnant women, women with dependent children, individuals with a
p.001321: co-occurring mental health and substance use
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
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p.001321: Sec. 1932 PUBLIC HEALTH SERVICE ACT 1322
p.001321:
p.001321: disorder, persons who inject drugs, and persons who are experiencing homelessness;
p.001321: (iv) provides a description of the system that is available to provide services by modality, including the
p.001321: provision of recovery support services;
p.001321: (v) provides a description of the State’s com- prehensive statewide prevention efforts, including
p.001321: the number of individuals being served in the system, tar- get populations, and priority needs, and provides a de-
p.001321: scription of the amount of funds from the prevention set-aside expended on primary prevention;
p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
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p.001361: 1361
p.001361: PUBLIC HEALTH SERVICE ACT
p.001361: Sec. 2111
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p.001361: January 30, 2020
p.001361: (c) PETITION CONTENT.—A petition for compensation under the Program for a vaccine-related injury or death shall
p.001361: contain—
p.001361: (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the
p.001361: person who suffered such injury or who died—
p.001361: (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a
p.001361: vaccine, con- tracted polio, directly or indirectly, from another person who received an oral polio vaccine,
p.001361: (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table—
p.001361: (I) received the vaccine in the United States or in its trust territories,
p.001361: (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person
p.001361: was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the
p.001361: United States or a dependent of such a citizen, or
p.001361: (III) received the vaccine outside the United States or a trust territory and the vaccine was manu-
p.001361: factured by a vaccine manufacturer located in the United States and such person returned to the United States
p.001361: not later than 6 months after the date of the vaccination,
p.001361: (ii) if such person did not receive such a vaccine but contracted polio from another person who received an
p.001361: oral polio vaccine, was a citizen of the United States or a de- pendent of such a citizen,
p.001361: (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the
p.001361: Vac- cine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the
p.001361: administration of such vaccine, and the first symptom or manifestation of the onset or of the significant
p.001361: aggravation of any such ill- ness, disability, injury, or condition or the death occurred within the
p.001361: time period after vaccine administration set forth in the Vaccine Injury Table, or
p.001361: (ii)(I) sustained, or had significantly aggravated, any illness, disability, injury, or condition not set
p.001361: forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
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p.001391: January 30, 2020
p.001391: percent’’ for any month after the 18th month of continuation coverage described in clause (i) or (ii) of
p.001391: paragraph (2)(A).
p.001391: (4) NO REQUIREMENT OF INSURABILITY.—The coverage may not be conditioned upon, or discriminate on the basis
p.001391: of lack of, evidence of insurability.
p.001391: (5) CONVERSION OPTION.—In the case of a qualified bene- ficiary whose period of continuation coverage
p.001391: expires under paragraph (2)(A), the plan must, during the 180-day period ending on such expiration date,
p.001391: provide to the qualified bene- ficiary the option of enrollment under a conversion health plan otherwise generally
p.001391: available under the plan.
p.001391: SEC. 2203. ø300bb–3¿ QUALIFYING EVENT.
p.001391: For purposes of this title, the term ‘‘qualifying event’’ means, with respect to any covered employee,
p.001391: any of the following events which, but for the continuation coverage required under this title, would
p.001391: result in the loss of coverage of a qualified beneficiary:
p.001391: (1) The death of the covered employee.
p.001391: (2) The termination (other than by reason of such employ- ee’s gross misconduct), or reduction of hours, of the
p.001391: covered employee’s employment.
p.001391: (3) The divorce or legal separation of the covered employee from the employee’s spouse.
p.001391: (4) The covered employee becoming entitled to benefits under title XVIII of the Social Security Act.
p.001391: (5) A dependent child ceasing to be a dependent child under the generally applicable requirements of the plan.
p.001391: SEC. 2204. ø300bb–4¿ APPLICABLE PREMIUM.
p.001391: For purposes of this title—
p.001391: (1) IN GENERAL.—The term ‘‘applicable premium’’ means, with respect to any period of continuation coverage of
p.001391: qualified beneficiaries, the cost to the plan for such period of the cov- erage for similarly situated
p.001391: beneficiaries with respect to whom a qualifying event has not occurred (without regard to whether such cost is paid by
p.001391: the employer or employee).
p.001391: (2) SPECIAL RULE FOR SELF-INSURED PLANS.—To the extent that a plan is a self-insured plan—
p.001391: (A) IN GENERAL.—Except as provided in subparagraph (B), the applicable premium for any period of continuation coverage
p.001391: of qualified beneficiaries shall be equal to a rea- sonable estimate of the cost of providing coverage for such
p.001391: period for similarly situated beneficiaries which—
p.001391: (i) is determined on an actuarial basis, and
p.001391: (ii) takes into account such factors as the Sec- retary may prescribe in regulations.
p.001391: (B) DETERMINATION ON BASIS OF PAST COST.—If a plan administrator elects to have this subparagraph apply,
p.001391: the applicable premium for any period of continuation cov- erage of qualified beneficiaries shall be equal to—
p.001391: (i) the cost to the plan for similarly situated bene- ficiaries for the same period occurring during the pre- ceding
p.001391: determination period under paragraph (3), ad- justed by
p.001391: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001391:
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p.001393: (d) CONTINUED COVERAGE OF COSTS OF A PEDIATRIC VACCINE UNDER CERTAIN GROUP HEALTH PLANS.—
p.001393: (1) REQUIREMENT.—The requirement of this paragraph, with respect to a group health plan for plan years
p.001393: beginning after the date of the enactment of this Act, is that the group health plan not reduce its coverage of the
p.001393: costs of pediatric vaccines (as defined under sec- tion 1928(h)(6) of the Social Security Act) below the coverage it
p.001393: provided as of May 1, 1993.
p.001393: (2) ENFORCEMENT.—For purposes of section 2207 of the Public Health Service Act, the re- quirement of paragraph (1) is
p.001393: deemed a requirement of title XXII of such Act.
p.001393: 6 So in law. The word ‘‘section’’ does not appear. See section 102(d) of Public Law 104–191 (110 Stat.
p.001393: 1978).
p.001393: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001395: 1395
p.001395: PUBLIC HEALTH SERVICE ACT
p.001395: Sec. 2302
p.001395:
p.001395: cluding as an employee defined in section 401(c)(1) of the Inter- nal Revenue Code of 1986).
p.001395: (3) QUALIFIED BENEFICIARY.—
p.001395: (A) IN GENERAL.—The term ‘‘qualified beneficiary’’ means, with respect to a covered employee under a
p.001395: group health plan, any other individual who, on the day before the qualifying event for that employee,
p.001395: is a beneficiary under the plan—
p.001395: (i) as the spouse of the covered employee, or
p.001395: (ii) as the dependent child of the employee.
p.001395: Such term shall also include a child who is born to or placed for adoption with the covered employee
p.001395: during the period of continuation coverage under this title. 7
p.001395: (B) SPECIAL RULE FOR TERMINATIONS AND REDUCED EMPLOYMENT.—In the case of a qualifying event described
p.001395: in section 2203(2), the term ‘‘qualified beneficiary’’ includes the covered employee.
p.001395: (4) PLAN ADMINISTRATOR.—The term ‘‘plan administrator’’ has the meaning given the term ‘‘administrator’’
p.001395: by section 3(16)(A) of the Employee Retirement Income Security Act of 1974.
p.001395: TITLE XXIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001395: PART A—ADMINISTRATION OF RESEARCH PROGRAMS
p.001395: SEC. 2302. ø300cc–1¿ REQUIREMENT OF EXPEDITING AWARDS OF GRANTS AND CONTRACTS FOR RESEARCH.
p.001395: (a) IN GENERAL.—The Secretary shall expedite the award of grants, contracts, and cooperative agreements for
p.001395: research projects relating to acquired immune deficiency syndrome (including such research projects initiated
p.001395: independently of any solicitation by the Secretary for proposals for such research projects).
p.001395: (b) TIME LIMITATIONS WITH RESPECT TO CERTAIN APPLICA-
p.001395: TIONS.—
p.001395: (1) With respect to programs of grants, contracts, and co- operative agreements described in subsection
p.001395: (a), any applica- tion submitted in response to a solicitation by the Secretary for proposals pursuant to such a
p.001395: program—
p.001395: (A) may not be approved if the application is sub- mitted after the expiration of the 3-month period
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p.001417: For purposes of this title:
p.001417: (1) The term ‘‘infection’’, with respect to the etiologic agent for acquired immune deficiency syndrome, includes
p.001417: opportun- istic cancers and infectious diseases and any other conditions arising from infection with such
p.001417: etiologic agent.
p.001417: (2) The term ‘‘treatment’’, with respect to the etiologic agent for acquired immune deficiency syndrome,
p.001417: includes pri- mary and secondary prophylaxis.
p.001417: TITLE XXIV—HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 1
p.001417: PART A—FORMULA GRANTS TO STATES FOR HOME AND COMMUNITY- BASED HEALTH SERVICES
p.001417: SEC. 2401. ø300dd¿ ESTABLISHMENT OF PROGRAM.
p.001417: (a) ALLOTMENTS FOR STATES.—For the purpose described in subsection (b), the Secretary shall for each of the
p.001417: fiscal years 1989 and 1990 make an allotment for each State in an amount deter- mined in accordance with
p.001417: section 2408. The Secretary shall make payments each such fiscal year to each State from the allotment for the
p.001417: State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant
p.001417: to section 2407.
p.001417: (b) PURPOSE OF GRANTS.—The Secretary may not make pay- ments under subsection (a) for a fiscal year
p.001417: unless the State in- volved agrees to expend the payments only for the purpose of pro- viding services in accordance
p.001417: with section 2402.
p.001417: (c) ELIGIBLE INDIVIDUAL DEFINED.—For purposes of this part:
p.001417: (1) The term ‘‘eligible individual’’ means an individual in- fected with the etiologic agent for acquired
p.001417: immune deficiency syndrome who either is medically dependent or chronically de- pendent.
p.001417: (2) The term ‘‘medically dependent’’ means, with respect to an individual, that the individual has been certified by a
p.001417: physi- cian as—
p.001417: (A) requiring the routine use of appropriate medical services (which may include home intravenous drug
p.001417: ther- apy) to prevent or compensate for the individual’s serious deterioration, arising from infection
p.001417: with the etiologic agent for acquired immune deficiency syndrome, of phys- ical health or cognitive
p.001417: function, and
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p.001417: January 30, 2020
p.001417: 1 See footnote at beginning of title XXIII.
p.001417:
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001417: Sec. 2402 PUBLIC HEALTH SERVICE ACT 1418
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p.001417: (B) being able to avoid long-term or repeated care as an inpatient or resident in a hospital, nursing
p.001417: facility, or other institution if home and community-based health services are provided to the individual.
p.001417: (3) The term ‘‘chronically dependent’’ means, with respect to an individual, that the individual has been
p.001417: certified by a physician as—
p.001417: (A) being unable to perform, because of physical or cognitive impairment (without substantial assistance
p.001417: from another individual) arising from infection with the etio- logic agent for acquired immune deficiency
p.001417: syndrome, at least 2 of the following activities of daily living: bathing, dressing, toileting, transferring,
p.001417: and eating, or
p.001417: (B) having a similar level of disability due to cognitive impairment (as defined by the Secretary).
p.001417: (d) HOME AND COMMUNITY-BASED HEALTH SERVICES DE- FINED.—For purposes of this part, the term ‘‘home and
p.001417: community- based health services’’—
p.001417: (1) means, with respect to an eligible individual, skilled health services furnished to the individual in
p.001417: the individual’s home pursuant to a written plan of care established by a health care professional for
p.001417: the provision of such services and items and services described in paragraph (2);
p.001417: (2) includes—
p.001417: (A) durable medical equipment,
p.001417: (B) homemaker/home health aide services and per- sonal care services furnished in the individual’s home,
...

p.001419: services by public and private entities; and
p.001419: (4) give priority to the provision of outreach and home and community-based services to eligible individuals with
p.001419: low in- comes.
p.001419: (b) AUTHORITY FOR GRANTS AND CONTRACTS.—A State may make payment for services under subsection (a)
p.001419: through grants to public and nonprofit private entities and through contracts with public and private
p.001419: entities. In providing such financial assistance, a State shall give priority to public and nonprofit
p.001419: private entities that have demonstrated experience in delivering home and commu- nity-based health services to
p.001419: individuals infected with the etiologic agent for acquired immune deficiency syndrome.
p.001419: SEC. 2403. ø300dd–2¿ REQUIREMENT OF SUBMISSION OF DESCRIPTION OF INTENDED USES OF GRANT.
p.001419: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001419: (1) the State submits to the Secretary a description of the purposes for which the State intends to expend such
p.001419: payments for the fiscal year;
p.001419: (2) such description provides information relating to the services and activities to be provided,
p.001419: including a description of the manner in which such services and activities will be co- ordinated with any similar
p.001419: services and activities of public and private entities; and
p.001419: (3) such description includes information relating to (A) the process for determining which eligible
p.001419: individuals are medically dependent or chronically dependent and (B) the proc- ess for establishing written plans
p.001419: of care for the provision of home and community-based health services under this part.
p.001419: SEC. 2404. ø300dd–3¿ RESTRICTIONS ON USE OF GRANT.
p.001419: (a) IN GENERAL.—The Secretary may not make payments under section 2401(a) for a fiscal year to a
p.001419: State unless the State agrees that the payments will not be expended—
p.001419: (1) to provide for items or services described in section 2401(d)(3);
p.001419: (2) to make cash payments to intended recipients of serv- ices;
p.001419: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property)
p.001419: or to purchase major medical equipment; or
p.001419: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001419: of Federal funds.
p.001419: (b) LIMITATION ON ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 2401(a) for a fiscal
p.001419: year un- less the State involved agrees that the State will not expend more than 5 percent of the payments made to the
p.001419: State under such sec- tion for administrative expenses with respect to carrying out the purpose of this part.
p.001419: (c) LIMITATION ON TOTAL PAYMENTS.—
p.001419: (1) Before March 1, 1989, for fiscal year 1989 and before September 1, 1989, for fiscal year 1990, the
p.001419: Secretary shall de-
p.001419: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001419:
p.001419:
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p.001545: Sec. 2704 PUBLIC HEALTH SERVICE ACT 1546
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p.001545: graph (1) or (2) with respect to previous coverage of an indi- vidual from adversely affecting any
p.001545: subsequent coverage of the individual under another group health plan or health insur- ance coverage.
p.001545: (f) SPECIAL ENROLLMENT PERIODS.—
p.001545: (1) INDIVIDUALS LOSING OTHER COVERAGE.—A group health plan, and a health insurance issuer offering group
p.001545: health in- surance coverage in connection with a group health plan, shall permit an employee who is eligible,
p.001545: but not enrolled, for cov- erage under the terms of the plan (or a dependent of such an employee if the
p.001545: dependent is eligible, but not enrolled, for cov- erage under such terms) to enroll for coverage under the terms of the
p.001545: plan if each of the following conditions is met:
p.001545: (A) The employee or dependent was covered under a group health plan or had health insurance coverage at the
p.001545: time coverage was previously offered to the employee or dependent.
p.001545: (B) The employee stated in writing at such time that coverage under a group health plan or health
p.001545: insurance coverage was the reason for declining enrollment, but only if the plan sponsor or issuer (if
p.001545: applicable) required such a statement at such time and provided the employee with notice of such requirement (and
p.001545: the consequences of such requirement) at such time.
p.001545: (C) The employee’s or dependent’s coverage described in subparagraph (A)—
p.001545: (i) was under a COBRA continuation provision and the coverage under such provision was
p.001545: exhausted; or
p.001545: (ii) was not under such a provision and either the coverage was terminated as a result of loss of eligi-
p.001545: bility for the coverage (including as a result of legal separation, divorce, death, termination of employment,
p.001545: or reduction in the number of hours of employment) or employer contributions toward such coverage were ter- minated.
p.001545: (D) Under the terms of the plan, the employee re- quests such enrollment not later than 30 days after
p.001545: the date of exhaustion of coverage described in subparagraph (C)(i) or termination of coverage or employer
p.001545: contribution described in subparagraph (C)(ii).
p.001545: (2) FOR DEPENDENT BENEFICIARIES.—
p.001545: (A) IN GENERAL.—If—
p.001545: (i) a group health plan makes coverage available with respect to a dependent of an individual,
p.001545: (ii) the individual is a participant under the plan (or has met any waiting period applicable to becoming a
p.001545: participant under the plan and is eligible to be en- rolled under the plan but for a failure to enroll during
p.001545: a previous enrollment period), and
p.001545: (iii) a person becomes such a dependent of the in- dividual through marriage, birth, or adoption or place- ment for
p.001545: adoption,
p.001545: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001547: 1547
p.001547: PUBLIC HEALTH SERVICE ACT
p.001547: Sec. 2704
p.001547:
p.001547: the group health plan shall provide for a dependent special enrollment period described in subparagraph (B)
p.001547: during which the person (or, if not otherwise enrolled, the indi- vidual) may be enrolled under the plan
p.001547: as a dependent of the individual, and in the case of the birth or adoption of a child, the spouse of
p.001547: the individual may be enrolled as a dependent of the individual if such spouse is otherwise eli- gible for
p.001547: coverage.
p.001547: (B) DEPENDENT SPECIAL ENROLLMENT PERIOD.—A de- pendent special enrollment period under this subpara-
p.001547: graph shall be a period of not less than 30 days and shall begin on the later of—
p.001547: (i) the date dependent coverage is made available, or
p.001547: (ii) the date of the marriage, birth, or adoption or placement for adoption (as the case may be) described in
p.001547: subparagraph (A)(iii).
p.001547: (C) NO WAITING PERIOD.—If an individual seeks to en- roll a dependent during the first 30 days of such a depend- ent
p.001547: special enrollment period, the coverage of the depend- ent shall become effective—
p.001547: (i) in the case of marriage, not later than the first day of the first month beginning after the date the
p.001547: completed request for enrollment is received;
p.001547: (ii) in the case of a dependent’s birth, as of the date of such birth; or
p.001547: (iii) in the case of a dependent’s adoption or place- ment for adoption, the date of such adoption or place- ment for
p.001547: adoption.
p.001547: (3) SPECIAL RULES FOR APPLICATION IN CASE OF MEDICAID AND CHIP.—
p.001547: (A) IN GENERAL.—A group health plan, and a health insurance issuer offering group health insurance
p.001547: coverage in connection with a group health plan, shall permit an employee who is eligible, but not
p.001547: enrolled, for coverage under the terms of the plan (or a dependent of such an em- ployee if the dependent is
p.001547: eligible, but not enrolled, for cov- erage under such terms) to enroll for coverage under the terms of the
p.001547: plan if either of the following conditions is met:
p.001547:
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p.001547: January 30, 2020
p.001547: (i) TERMINATION OF MEDICAID OR CHIP COV- ERAGE.—The employee or dependent is covered under a
p.001547: Medicaid plan under title XIX of the Social Security Act or under a State child health plan under title XXI of such Act
p.001547: and coverage of the employee or dependent under such a plan is terminated as a result of loss of eligibility
p.001547: for such coverage and the employee requests coverage under the group health plan (or health insur- ance coverage) not
p.001547: later than 60 days after the date of termination of such coverage.
p.001547: (ii) ELIGIBILITY FOR EMPLOYMENT ASSISTANCE UNDER MEDICAID OR CHIP.—The employee or depend- ent
p.001547: becomes eligible for assistance, with respect to cov- erage under the group health plan or health insurance
p.001547: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001547:
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p.001547: Sec. 2704 PUBLIC HEALTH SERVICE ACT 1548
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p.001547: coverage, under such Medicaid plan or State child health plan (including under any waiver or demonstra- tion
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p.001549: (2) AFFILIATION PERIOD.—
p.001549: (A) DEFINED.—For purposes of this title, the term ‘‘af- filiation period’’ means a period which, under the terms of the
p.001549: health insurance coverage offered by the health main- tenance organization, must expire before the health insur- ance
p.001549: coverage becomes effective. The organization is not required to provide health care services or benefits during
p.001549: such period and no premium shall be charged to the par- ticipant or beneficiary for any coverage during
p.001549: the period.
p.001549: (B) BEGINNING.—Such period shall begin on the enroll- ment date.
p.001549: (C) RUNS CONCURRENTLY WITH WAITING PERIODS.—An affiliation period under a plan shall run concurrently with any
p.001549: waiting period under the plan.
p.001549: (3) ALTERNATIVE METHODS.—A health maintenance organi- zation described in paragraph (1) may use alternative methods,
p.001549: from those described in such paragraph, to address adverse se- lection as approved by the State insurance commissioner
p.001549: or of- ficial or officials designated by the State to enforce the require- ments of this part for the State
p.001549: involved with respect to such issuer.
p.001549: SEC. 2705. ø300gg–4¿ PROHIBITING DISCRIMINATION AGAINST INDI- VIDUAL PARTICIPANTS AND BENEFICIARIES BASED ON
p.001549: HEALTH STATUS.
p.001549: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001549: coverage may not establish rules for eligibility (including continued eligibility) of any individual to enroll
p.001549: under the terms of the plan or coverage based on any of the following health status-related factors in rela-
p.001549: tion to the individual or a dependent of the individual:
p.001549: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001549:
p.001549:
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p.001549:
p.001549: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1550
p.001549:
p.001549: (1) Health status.
p.001549: (2) Medical condition (including both physical and mental illnesses).
p.001549: (3) Claims experience.
p.001549: (4) Receipt of health care.
p.001549: (5) Medical history.
p.001549: (6) Genetic information.
p.001549: (7) Evidence of insurability (including conditions arising out of acts of domestic violence).
p.001549: (8) Disability.
p.001549: (9) Any other health status-related factor determined ap- propriate by the Secretary.
p.001549: (b) IN PREMIUM CONTRIBUTIONS.—
p.001549: (1) IN GENERAL.—A group health plan, and a health insur- ance issuer offering group or individual health
p.001549: insurance cov- erage, may not require any individual (as a condition of enroll- ment or continued enrollment under
p.001549: the plan) to pay a pre- mium or contribution which is greater than such premium or contribution for a
p.001549: similarly situated individual enrolled in the plan on the basis of any health status-related factor in relation to
p.001549: the individual or to an individual enrolled under the plan as a dependent of the individual.
p.001549: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued—
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p.001549: January 30, 2020
p.001549: (A) to restrict the amount that an employer or indi- vidual may be charged for coverage under a group
p.001549: health plan except as provided in paragraph (3) or individual health coverage, as the case may be; or
p.001549: (B) to prevent a group health plan, and a health insur- ance issuer offering group health insurance coverage, from
p.001549: establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in
p.001549: return for adherence to programs of health promotion and disease prevention.
p.001549: (3) NO GROUP-BASED DISCRIMINATION ON BASIS OF GENETIC INFORMATION.—
p.001549: (A) IN GENERAL.—For purposes of this section, a group health plan, and health insurance issuer offering group or
p.001549: individual health insurance coverage, may not adjust pre- mium or contribution amounts for the group covered
p.001549: under such plan on the basis of genetic information.
p.001549: (B) RULE OF CONSTRUCTION.—Nothing in subpara- graph (A) or in paragraphs (1) and (2) of subsection
p.001549: (d) shall be construed to limit the ability of a health insurance issuer offering group or individual health
p.001549: insurance cov- erage to increase the premium for an employer based on the manifestation of a disease or
...

p.001553: (B) A diagnostic testing program that provides a re- ward for participation and does not base any part
p.001553: of the reward on outcomes.
p.001553: (C) A program that encourages preventive care related to a health condition through the waiver of the copayment or
p.001553: deductible requirement under group health plan for the costs of certain items or services related to a health condi-
p.001553: tion (such as prenatal care or well-baby visits).
p.001553: (D) A program that reimburses individuals for the costs of smoking cessation programs without regard to
p.001553: whether the individual quits smoking.
p.001553: (E) A program that provides a reward to individuals for attending a periodic health education seminar.
p.001553: (3) WELLNESS PROGRAMS SUBJECT TO REQUIREMENTS.—If any of the conditions for obtaining a premium discount,
p.001553: rebate, or reward under a wellness program as described in paragraph (1)(C) is based on an individual satisfying
p.001553: a standard that is related to a health status factor, the wellness program shall not violate this
p.001553: section if the following requirements are com- plied with:
p.001553: (A) The reward for the wellness program, together with the reward for other wellness programs with
p.001553: respect to the plan that requires satisfaction of a standard related to a health status factor, shall not exceed 30
p.001553: percent of the cost of employee-only coverage under the plan. If, in addi- tion to employees or individuals, any
p.001553: class of dependents (such as spouses or spouses and dependent children) may participate fully in the
p.001553: wellness program, such reward shall not exceed 30 percent of the cost of the coverage in which an
p.001553: employee or individual and any dependents are enrolled. For purposes of this paragraph, the cost of cov-
p.001553: erage shall be determined based on the total amount of employer and employee contributions for the benefit
p.001553: pack- age under which the employee is (or the employee and any dependents are) receiving coverage. A reward may
p.001553: be in the form of a discount or rebate of a premium or contribu-
p.001553: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001553:
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p.001553: Sec. 2705 PUBLIC HEALTH SERVICE ACT 1554
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p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001561: Sec. 2714 PUBLIC HEALTH SERVICE ACT 1562
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p.001561: January 30, 2020
p.001561:
p.001561: scribed in subsection (a)(1) or (a)(2) or a guideline under sub- section (a)(3) is issued and the plan year
p.001561: with respect to which the requirement described in subsection (a) is effective with re- spect to the service
p.001561: described in such recommendation or guideline.
p.001561: (2) MINIMUM.—The interval described in paragraph (1) shall not be less than 1 year.
p.001561: (c) VALUE-BASED INSURANCE DESIGN.—The Secretary may de- velop guidelines to permit a group health plan and a
p.001561: health insur- ance issuer offering group or individual health insurance coverage to utilize value-based
p.001561: insurance designs.
p.001561: SEC. 2714. ø300gg–14¿ EXTENSION OF DEPENDENT COVERAGE.
p.001561: (a) IN GENERAL.—A group health plan and a health insurance issuer offering group or individual health insurance
p.001561: coverage that provides dependent coverage of children shall continue to make such coverage available for
p.001561: an adult child until the child turns 26 years of age. Nothing in this section shall require a health plan or a
p.001561: health insurance issuer described in the preceding sentence to make coverage available for a child of a
p.001561: child receiving dependent coverage.
p.001561: (b) REGULATIONS.—The Secretary shall promulgate regulations to define the dependents to which coverage shall be made
p.001561: available under subsection (a).
p.001561: (c) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to modify the definition of ‘‘dependent’’
p.001561: as used in the In- ternal Revenue Code of 1986 with respect to the tax treatment of the cost of coverage.
p.001561: SEC. 2715. ø300gg–15¿ DEVELOPMENT AND UTILIZATION OF UNIFORM EXPLANATION OF COVERAGE DOCUMENTS AND STAND-
p.001561: ARDIZED DEFINITIONS.
p.001561: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Patient Protection and
p.001561: Affordable Care Act, the Secretary shall develop standards for use by a group health plan and a health
p.001561: insurance issuer offering group or individual health insurance coverage, in compiling and providing to
p.001561: applicants, en- rollees, and policyholders or certificate holders a summary of bene- fits and coverage explanation
p.001561: that accurately describes the benefits and coverage under the applicable plan or coverage. In developing such
p.001561: standards, the Secretary shall consult with the National Asso- ciation of Insurance Commissioners (referred to in
p.001561: this section as the ‘‘NAIC’’), a working group composed of representatives of health
p.001561: insurance-related consumer advocacy organizations, health insurance issuers, health care professionals,
p.001561: patient advocates in- cluding those representing individuals with limited English pro- ficiency, and other
p.001561: qualified individuals.
p.001561: (b) REQUIREMENTS.—The standards for the summary of bene- fits and coverage developed under subsection (a)
p.001561: shall provide for the following:
p.001561: (1) APPEARANCE.—The standards shall ensure that the summary of benefits and coverage is presented in a
...

p.001583: be), but does not include mental health or substance use disorder benefits.
p.001583: (4) MENTAL HEALTH BENEFITS.—The term ‘‘mental health benefits’’ means benefits with respect to services
p.001583: for mental health conditions, as defined under the terms of the plan and in accordance with applicable
p.001583: Federal and State law.
p.001583: (5) SUBSTANCE USE DISORDER BENEFITS.—The term ‘‘sub- stance use disorder benefits’’ means benefits with
p.001583: respect to services for substance use disorders, as defined under the terms of the plan and in
p.001583: accordance with applicable Federal and State law.
p.001583: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001583:
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p.001585: 1585
p.001585: PUBLIC HEALTH SERVICE ACT
p.001585: Sec. 2728
p.001585:
p.001585: SEC. 2727. ø300gg–27¿ REQUIRED COVERAGE FOR RECONSTRUCTIVE SURGERY FOLLOWING MASTECTOMIES. 12
p.001585: The provisions of section 713 of the Employee Retirement In- come Security Act of 1974 shall apply to
p.001585: group health plans, and and 13 health insurance issuers offering group or individual health insurance
p.001585: coverage, as if included in this subpart.
p.001585: SEC. 2728. ø300gg–28¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE.
p.001585: (a) MEDICALLY NECESSARY LEAVE OF ABSENCE.—In this sec- tion, the term ‘‘medically necessary leave of
p.001585: absence’’ means, with respect to a dependent child described in subsection (b)(2) in con- nection with a
p.001585: group health plan or individual health insurance coverage, a leave of absence of such child from a
p.001585: postsecondary educational institution (including an institution of higher education as defined in section 102 of
p.001585: the Higher Education Act of 1965), or any other change in enrollment of such child at such an institution, that—
p.001585: (1) commences while such child is suffering from a serious illness or injury;
p.001585: (2) is medically necessary; and
p.001585: (3) causes such child to lose student status for purposes of coverage under the terms of the plan or coverage.
p.001585: (b) REQUIREMENT TO CONTINUE COVERAGE.—
p.001585: (1) IN GENERAL.—In the case of a dependent child de- scribed in paragraph (2), a group health plan, or
p.001585: a health in- surance issuer that offers group or individual health insurance coverage, shall not terminate coverage
p.001585: of such child under such plan or health insurance coverage due to a medically necessary leave of absence before the
p.001585: date that is the earlier of—
p.001585: (A) the date that is 1 year after the first day of the medically necessary leave of absence; or
p.001585: (B) the date on which such coverage would otherwise terminate under the terms of the plan or health insurance
p.001585: coverage.
p.001585: (2) DEPENDENT CHILD DESCRIBED.—A dependent child de- scribed in this paragraph is, with respect to a
p.001585: group health plan or individual health insurance coverage, a beneficiary under the plan who—
p.001585: (A) is a dependent child, under the terms of the plan or coverage, of a participant or beneficiary under the
p.001585: plan or coverage; and
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p.001585: January 30, 2020
p.001585: 12 Section 2706 (prior to its redesignation as 2727 by Public Law 111–148) was added by sub- section (a) of section
p.001585: 903 of the Departments of Labor, Health and Human Services, and Edu- cation, and Related Agencies
p.001585: Appropriations Act, 1999 (as contained in section 101(f) of division A of Public Law 105–277; 112 Stat. 2681–438).
p.001585: Subsection (c) of such section 903 concerns effec- tive dates, and paragraph (1) of the subsection provides as follows:
p.001585: ‘‘(1) GROUP PLANS.—
p.001585: ‘‘(A) IN GENERAL.—The amendment made by subsection (a) shall apply to group health plans for plan years
p.001585: beginning on or after the date of enactment of this Act.
p.001585: ‘‘(B) SPECIAL RULE FOR COLLECTIVE BARGAINING AGREEMENTS.—In the case of a group
p.001585: health plan maintained pursuant to 1 or more collective bargaining agreements be- tween employee
p.001585: representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining
p.001585: agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment
p.001585: made by subsection
p.001585: (a) shall not be treated as a termination of such collective bargaining agreement.’’.
p.001585: The Public Law was enacted October 21, 1998.
p.001585: 13 So in law.
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001585:
p.001585: Sec. 2729 PUBLIC HEALTH SERVICE ACT 1586
p.001585:
p.001585: (B) was enrolled in the plan or coverage, on the basis of being a student at a postsecondary educational
p.001585: institu- tion (as described in subsection (a)), immediately before the first day of the medically
p.001585: necessary leave of absence involved.
p.001585: (3) CERTIFICATION BY PHYSICIAN.—Paragraph (1) shall apply to a group health plan or individual
p.001585: health insurance coverage only if the plan or issuer of the coverage has received written certification by a
p.001585: treating physician of the dependent child which states that the child is suffering from a serious ill- ness or
p.001585: injury and that the leave of absence (or other change of enrollment) described in subsection (a) is
p.001585: medically nec- essary.
p.001585: (c) NOTICE.—A group health plan, and a health insurance issuer that offers group or individual health
p.001585: insurance coverage, shall include, with any notice regarding a requirement for certifi- cation of student
p.001585: status for coverage under the plan or coverage, a description of the terms of this section for
p.001585: continued coverage during medically necessary leaves of absence. Such description shall be in language
p.001585: which is understandable to the typical plan participant.
p.001585: (d) NO CHANGE IN BENEFITS.—A dependent child whose bene- fits are continued under this section shall
p.001585: be entitled to the same benefits as if (during the medically necessary leave of absence) the child continued to be
p.001585: a covered student at the institution of higher education and was not on a medically necessary leave of
p.001585: absence.
p.001585: (e) CONTINUED APPLICATION IN CASE OF CHANGED COV-
p.001585: ERAGE.—If—
p.001585: (1) a dependent child of a participant or beneficiary is in a period of coverage under a group health
p.001585: plan or individual health insurance coverage, pursuant to a medically necessary leave of absence of the child
p.001585: described in subsection (b);
p.001585: (2) the manner in which the participant or beneficiary is covered under the plan changes, whether through a
p.001585: change in health insurance coverage or health insurance issuer, a change between health insurance coverage and
p.001585: self-insured coverage, or otherwise; and
p.001585: (3) the coverage as so changed continues to provide cov- erage of beneficiaries as dependent children,
p.001585: this section shall apply to coverage of the child under the changed coverage for the remainder of the period of the
p.001585: medically necessary leave of absence of the dependent child under the plan in the same manner as it would have applied
p.001585: if the changed coverage had been the previous coverage.
p.001585: SEC. 2729. INFORMATION ON PRESCRIPTION DRUGS.
p.001585: (a) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health
p.001585: insurance coverage shall—
p.001585:
p.001585:
p.001585:
p.001585:
p.001585:
p.001585: January 30, 2020
p.001585: (1) not restrict, directly or indirectly, any pharmacy that dispenses a prescription drug to an enrollee in the
p.001585: plan or cov- erage from informing (or penalize such pharmacy for inform- ing) an enrollee of any
p.001585: differential between the enrollee’s out- of-pocket cost under the plan or coverage with respect to acqui-
p.001585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001585:
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p.001587: 1587
p.001587: PUBLIC HEALTH SERVICE ACT
p.001587: Sec. 2722
p.001587:
p.001587: sition of the drug and the amount an individual would pay for acquisition of the drug without using any health plan or
p.001587: health insurance coverage; and
p.001587: (2) ensure that any entity that provides pharmacy benefits management services under a contract with any such
p.001587: health plan or health insurance coverage does not, with respect to such plan or coverage, restrict,
...

p.001609: 2014 to reflect the probable intent of
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001609:
p.001611: 1611
p.001611: PUBLIC HEALTH SERVICE ACT
p.001611: Sec. 2791
p.001611:
p.001611: (1) IN GENERAL.—The provisions of part A shall apply to health insurance issuers providing health
p.001611: insurance coverage in the individual market in a State as provided for in such part.
p.001611: (2) CLARIFICATION.—To the extent that any provision of this part conflicts with a provision of part A
p.001611: with respect to health insurance issuers providing health insurance coverage in the individual market in a
p.001611: State, the provisions of such part A shall apply.
p.001611: SEC. 2763. ø300gg–63¿ GENERAL EXCEPTIONS.
p.001611: (a) EXCEPTION FOR CERTAIN BENEFITS.—The requirements of this part shall not apply to any health insurance
p.001611: coverage in rela- tion to its provision of excepted benefits described in section 2791(c)(1).
p.001611: (b) EXCEPTION FOR CERTAIN BENEFITS IF CERTAIN CONDITIONS MET.—The requirements of this part shall not apply to
p.001611: any health insurance coverage in relation to its provision of excepted benefits described in paragraph (2),
p.001611: (3), or (4) of section 2791(c) if the bene- fits are provided under a separate policy, certificate, or contract of
p.001611: insurance.
p.001611: SEC. 2753. ø300gg–54¿ COVERAGE OF DEPENDENT STUDENTS ON MEDI- CALLY NECESSARY LEAVE OF ABSENCE. 28
p.001611: The provisions of section 2707 shall apply to health insurance coverage offered by a health insurance
p.001611: issuer in the individual market in the same manner as they apply to health insurance cov- erage offered by a
p.001611: health insurance issuer in connection with a group health plan in the small or large group market.
p.001611: PART C—DEFINITIONS; MISCELLANEOUS PROVISIONS
p.001611: SEC. 2791. ø300gg–91¿ DEFINITIONS.
p.001611: (a) GROUP HEALTH PLAN.—
p.001611: (1) DEFINITION.—The term ‘‘group health plan’’ means an employee welfare benefit plan (as defined in section
p.001611: 3(1) of the Employee Retirement Income Security Act of 1974) to the ex- tent that the plan provides
p.001611: medical care (as defined in para- graph (2)) and including items and services paid for as medical care) to
p.001611: employees or their dependents (as defined under the terms of the plan) directly or through insurance,
p.001611: reimburse- ment, or otherwise. Except for purposes of part C of title XI of the Social Security Act (42 U.S.C.
p.001611: 1320d et seq.), such term shall not include any qualified small employer health reim- bursement arrangement
p.001611: (as defined in section 9831(d)(2) of the Internal Revenue Code of 1986).
p.001611: (2) MEDICAL CARE.—The term ‘‘medical care’’ means amounts paid for—
p.001611:
p.001611:
p.001611:
p.001611:
p.001611:
p.001611:
p.001611:
p.001611: January 30, 2020
p.001611: Congress and in order to be consistent with the execution of different amendments made by such section
...

p.001613: (12) PLACED FOR ADOPTION DEFINED.—The term ‘‘place- ment’’, or being ‘‘placed’’, for adoption, in
p.001613: connection with any
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001613:
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p.001613:
p.001613:
p.001615: 1615
p.001615: PUBLIC HEALTH SERVICE ACT
p.001615: Sec. 2791
p.001615:
p.001615: placement for adoption of a child with any person, means the assumption and retention by such person of
p.001615: a legal obligation for total or partial support of such child in anticipation of adop- tion of such child. The
p.001615: child’s placement with such person ter- minates upon the termination of such legal obligation.
p.001615: (13) PLAN SPONSOR.—The term ‘‘plan sponsor’’ has the meaning given such term under section 3(16)(B) of
p.001615: the Em- ployee Retirement Income Security Act of 1974.
p.001615: (14) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, Puerto Rico,
p.001615: the Virgin Is- lands, Guam, American Samoa, and the Northern Mariana Is- lands.
p.001615: (15) FAMILY MEMBER.—The term ‘‘family member’’ means, with respect to any individual—
p.001615: (A) a dependent (as such term is used for purposes of section 2701(f)(2)) of such individual; and
p.001615: (B) any other individual who is a first-degree, second- degree, third-degree, or fourth-degree relative of such indi-
p.001615: vidual or of an individual described in subparagraph (A).
p.001615: (16) GENETIC INFORMATION.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic information’’ means, with respect to any individual, information about—
p.001615: (i) such individual’s genetic tests,
p.001615: (ii) the genetic tests of family members of such in- dividual, and
p.001615: (iii) the manifestation of a disease or disorder in family members of such individual.
p.001615: (B) INCLUSION OF GENETIC SERVICES AND PARTICIPA- TION IN GENETIC RESEARCH.—Such term includes, with re-
p.001615: spect to any individual, any request for, or receipt of, ge- netic services, or participation in
p.001615: clinical research which includes genetic services, by such individual or any family member of such individual.
p.001615: (C) EXCLUSIONS.—The term ‘‘genetic information’’ shall not include information about the sex or age
p.001615: of any individual.
p.001615: (17) GENETIC TEST.—
p.001615: (A) IN GENERAL.—The term ‘‘genetic test’’ means an analysis of human DNA, RNA, chromosomes, proteins, or
p.001615: metabolites, that detects genotypes, mutations, or chromo- somal changes.
p.001615: (B) EXCEPTIONS.—The term ‘‘genetic test’’ does not mean—
p.001615:
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p.001615:
p.001615:
p.001615:
p.001615:
p.001615:
p.001615: January 30, 2020
...

General/Other / Developing Country

Searching for indicator underdeveloped:

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p.000733: (v) The Director of the National Institute on Deafness and Other Communication Disorders.
p.000733: (vi) The Director of the National Heart, Lung, and Blood Institute.
p.000733: (vii) The Director of the National Institute of Neurological Disorders and Stroke.
p.000733: (viii) The Director of the National Institute on Disability and Rehabilitation Research.
p.000733: (ix) The Director of the Division of Program Coordination, Planning, and Strategic Initiatives.
p.000733: (x) The Commissioner for Rehabilitation Services Adminis- tration.
p.000733: (xi) The Assistant Secretary of Defense (Health Affairs).
p.000733: (xii) The Chief Medical Director of the Department of Vet- erans Affairs.
p.000733: (4) The members of the Advisory Board shall, from among the members appointed under paragraph (3)(A), designate
p.000733: an indi- vidual to serve as the chair of the Advisory Board.
p.000733: (g)(1) The Secretary and the heads of other Federal agencies shall jointly review the programs carried out (or
p.000733: proposed to be car- ried out) by each such official with respect to medical rehabilitation research and, as
p.000733: appropriate, enter into agreements preventing du- plication among such programs.
p.000733: (2) The Secretary shall, as appropriate, enter into interagency agreements relating to the coordination of
p.000733: medical rehabilitation research conducted by agencies of the National Institutes of Health and other agencies of the
p.000733: Federal Government.
p.000733: (h) For purposes of this section, the term ‘‘medical rehabilita- tion research’’ means the science of
p.000733: mechanisms and interventions that prevent, improve, restore, or replace lost, underdeveloped, or deteriorating
p.000733: function.
p.000733:
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p.000733: January 30, 2020
p.000733: RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND INFERTILITY
p.000733: SEC. 452A. ø285g–5¿ (a) The Director of the Institute, after consultation with the advisory council for the
p.000733: Institute, shall make grants to, or enter into contracts with, public or nonprofit private entities for the
p.000733: development and operation of centers to conduct ac- tivities for the purpose of improving methods of
p.000733: contraception and centers to conduct activities for the purpose of improving methods of diagnosis and
p.000733: treatment of infertility.
p.000733: (b) In carrying out subsection (a), the Director of the Institute shall, subject to the extent of amounts made
p.000733: available in appropria- tions Acts, provide for the establishment of three centers with re- spect to
p.000733: contraception and for two centers with respect to infer- tility.
p.000733: (c)(1) Each center assisted under this section shall, in carrying out the purpose of the center involved—
p.000733: (A) conduct clinical and other applied research, including—
p.000733: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000733:
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p.000733:
p.000733: Sec. 452B PUBLIC HEALTH SERVICE ACT 734
p.000733:
...

General/Other / Diminished Autonomy

Searching for indicator diminished:

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p.000391: include information demonstrating that the biological product meets the standards described in paragraph (4).
p.000391: (3) EVALUATION BY SECRETARY.—Upon review of an appli- cation (or a supplement to an application) submitted under
p.000391: this subsection, the Secretary shall license the biological product under this subsection if—
p.000391: (A) the Secretary determines that the information sub- mitted in the application (or the supplement) is
p.000391: sufficient to show that the biological product—
p.000391: (i) is biosimilar to the reference product; or
p.000391: (ii) meets the standards described in paragraph (4), and therefore is interchangeable with the ref-
p.000391: erence product; and
p.000391: (B) the applicant (or other appropriate person) con- sents to the inspection of the facility that is the subject
p.000391: of the application, in accordance with subsection (c).
p.000391: (4) SAFETY STANDARDS FOR DETERMINING INTERCHANGE- ABILITY.—Upon review of an application submitted under
p.000391: this subsection or any supplement to such application, the Sec- retary shall determine the biological product
p.000391: to be interchange- able with the reference product if the Secretary determines that the information submitted
p.000391: in the application (or a supple- ment to such application) is sufficient to show that—
p.000391: (A) the biological product—
p.000391: (i) is biosimilar to the reference product; and
p.000391: (ii) can be expected to produce the same clinical result as the reference product in any given patient;
p.000391: and
p.000391: (B) for a biological product that is administered more than once to an individual, the risk in terms
p.000391: of safety or diminished efficacy of alternating or switching between use of the biological product and
p.000391: the reference product is not greater than the risk of using the reference product without such alternation
p.000391: or switch.
p.000391: (5) GENERAL RULES.—
p.000391: (A) ONE REFERENCE PRODUCT PER APPLICATION.—A bi- ological product, in an application submitted under this
p.000391: subsection, may not be evaluated against more than 1 ref- erence product.
p.000391: (B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within
p.000391: the Food and Drug Administration that is responsible for the review and approval of the application under
p.000391: which the reference product is licensed.
p.000391: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000391:
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p.000391:
p.000391: Sec. 351 PUBLIC HEALTH SERVICE ACT 392
p.000391:
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p.001487:
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p.001487: January 30, 2020
p.001487: regard to whether the contributions are made for pro- grams established pursuant to this title;
p.001487: (ii) In making a determination for purposes of clause (i), the Secretary may not include any non-Fed- eral
p.001487: contributions provided by the State as a condition of receiving Federal funds under any program under this title
p.001487: (except for the program established in section 2611) or under other provisions of law.
p.001487: (3) APPLICABILITY OF REQUIREMENT.—
p.001487: (A) NUMBER OF CASES.—A State referred to in para- graph (1) is any State for which the number of
p.001487: cases of HIV/AIDS reported to and confirmed by the Director of the Centers for Disease Control and Prevention
p.001487: for the period described in subparagraph (B) constitutes in excess of 1 percent of the aggregate number of
p.001487: such cases reported to and confirmed by the Director for such period for the United States.
p.001487: (B) PERIOD OF TIME.—The period referred to in sub- paragraph (A) is the 2-year period preceding the fiscal year
p.001487: for which the State involved is applying to receive a grant under subsection (a).
p.001487: (C) PUERTO RICO.—For purposes of paragraph (1), the number of cases of HIV/AIDS reported and confirmed for the
p.001487: Commonwealth of Puerto Rico for any fiscal year shall be deemed to be less than 1 percent.
p.001487: (4) DIMINISHED STATE CONTRIBUTION.—With respect to a State that does not make available the entire
p.001487: amount of the non-Federal contribution referred to in paragraph (1), the State shall continue to be
p.001487: eligible to receive Federal funds under a grant under section 2611, except that the Secretary in providing
p.001487: Federal funds under the grant shall provide such funds (in accordance with the ratios prescribed in
p.001487: paragraph (1)) only with respect to the amount of funds contributed by such State.
p.001487: SEC. 2618. ø300ff–28¿ DISTRIBUTION OF FUNDS.
p.001487: (a) AMOUNT OF GRANT TO STATE.—
p.001487: (1) MINIMUM ALLOTMENT.—Subject to the extent of amounts made available under section 2623, the
p.001487: amount of a grant to be made under section 2611 for—
p.001487: (A) each of the 50 States, the District of Columbia, Guam, and the Virgin Islands (referred to in this
p.001487: para- graph as a ‘‘covered State’’) for a fiscal year shall be the greater of—
p.001487: (i)(I) with respect to a covered State that has less than 90 living cases of AIDS, as determined under
p.001487: paragraph (2)(D), $200,000; or
p.001487: (II) with respect to a covered State that has 90 or more living cases of AIDS, as determined under para- graph (2)(D),
p.001487: $500,000; and
p.001487: (ii) an amount determined under paragraph (2) and then, as applicable, increased under paragraph (2)(H);
p.001487: and
p.001487: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001487:
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p.001487:
...

General/Other / Incapacitated

Searching for indicator incapacitated:

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p.000527:
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p.000527: January 30, 2020
p.000527:
p.000527: (G) CIVIL LIABILITY PROTECTION LAW.—The certifi- cation required in subparagraph (F) shall be a
p.000527: certification made by the State attorney general that the State has re- viewed any applicable civil liability
p.000527: protection law to deter- mine the application of such law with regard to elemen- tary and secondary school
p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
p.000527: administer epinephrine on a voluntary basis outside their scope of employment;
p.000527: (ii) who has received training in the administra- tion of epinephrine; and
...

p.001697: participants;
p.001697: (B) data at the smallest geographic level such as State, local, or institutional levels if such
p.001697: data can be ag- gregated;
p.001697: (C) sufficient data to generate statistically reliable es- timates by racial, ethnic, sex, primary language, and
p.001697: dis- ability status subgroups for applicants, recipients or par- ticipants using, if needed, statistical
p.001697: oversamples of these subpopulations; and
p.001697: (D) any other demographic data as deemed appro- priate by the Secretary regarding health disparities.
p.001697: (2) COLLECTION STANDARDS.—In collecting data described in paragraph (1), the Secretary or designee shall—
p.001697: (A) use Office of Management and Budget standards, at a minimum, for race and ethnicity measures;
p.001697: (B) develop standards for the measurement of sex, pri- mary language, and disability status;
p.001697: (C) develop standards for the collection of data de- scribed in paragraph (1) that, at a minimum—
p.001697: (i) collects self-reported data by the applicant, re- cipient, or participant; and
p.001697: (ii) collects data from a parent or legal guardian if the applicant, recipient, or participant is a minor or
p.001697: legally incapacitated;
p.001697: (D) survey health care providers and establish other procedures in order to assess access to care and treatment
p.001697: for individuals with disabilities and to identify—
p.001697: (i) locations where individuals with disabilities ac- cess primary, acute (including intensive), and long- term
p.001697: care;
p.001697: (ii) the number of providers with accessible facili- ties and equipment to meet the needs of the
p.001697: individ- uals with disabilities, including medical diagnostic equipment that meets the minimum technical
p.001697: criteria set forth in section 510 of the Rehabilitation Act of 1973; and
p.001697: (iii) the number of employees of health care pro- viders trained in disability awareness and patient care of
p.001697: individuals with disabilities; and
p.001697: (E) require that any reporting requirement imposed for purposes of measuring quality under any ongoing or
p.001697: federally conducted or supported health care or public health program, activity, or survey includes
p.001697: requirements for the collection of data on individuals receiving health care items or services under such
p.001697: programs activities by race, ethnicity, sex, primary language, and disability sta- tus.
p.001697: (3) DATA MANAGEMENT.—In collecting data described in paragraph (1), the Secretary, acting through the
p.001697: National Co- ordinator for Health Information Technology shall—
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General/Other / Natural Hazards

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p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
p.000135:
p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
p.000135: poisoning prevention from surveillance to lead hazard con- trol.
p.000135: (2) STATE MATCH.—A State is not eligible for a grant under this section unless the State agrees to expend
p.000135: (through State or local funds) $1 for every $2 provided under the grant to carry out the activities
p.000135: described in paragraph (1).
p.000135: (3) APPLICATION.—To be eligible to receive a grant under this section, a State shall submit an
p.000135: application to the Sec- retary in such form and manner and containing such informa- tion as the Secretary may
p.000135: require.
p.000135: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—A State shall identify in the application for a grant
p.000135: under this section how the State will coordinate operations and activities under the grant with—
p.000135: (1) other programs operated in the State that serve chil- dren with elevated blood lead levels,
p.000135: including any such pro- grams operated under title V, XIX, or XXI of the Social Secu- rity Act; and
p.000135: (2) one or more of the following—
p.000135: (A) the child welfare and foster care and adoption as- sistance programs under parts B and E of title IV of
p.000135: such Act;
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p.000135: January 30, 2020
p.000135: (B) the head start program established under the
p.000135: Head Start Act (42 U.S.C. 9831 et seq.);
...

p.000387: (E)(i) The Secretary may rely upon qualified data summaries to support the approval of a supplemental
p.000387: application, with respect to a qualified indication for a drug, submitted under this sub- section, if such
p.000387: supplemental application complies with the require- ments of subparagraph (B) of section 505(c)(5) of the Federal Food,
p.000387: Drug, and Cosmetic Act.
p.000387: (ii) In this subparagraph, the terms ‘‘qualified indication’’ and ‘‘qualified data summary’’ have the
p.000387: meanings given such terms in section 505(c)(5) of the Federal Food, Drug, and Cosmetic Act.
p.000387: (3) The Secretary shall prescribe requirements under which a biological product undergoing investigation
p.000387: shall be exempt from the requirements of paragraph (1).
p.000387: (b) No person shall falsely label or mark any package or con- tainer of any biological product or
p.000387: alter any label or mark on the package or container of the biological product so as to falsify the
p.000387: label or mark.
p.000387: (c) Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the
p.000387: purpose, may during all reasonable hours enter and inspect any establish- ment for the propagation or
p.000387: manufacture and preparation of any biological product.
p.000387: (d)(1) Upon a determination that a batch, lot, or other quantity of a product licensed under this section
p.000387: presents an imminent or substantial hazard to the public health, the Secretary shall issue an order
p.000387: immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this
p.000387: paragraph shall be issued in accordance with section 554 of title 5, United States Code.
p.000387: (2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per
p.000387: day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year
p.000387: beginning 1 year after the effective date of this para- graph, be increased by the percent change in the
p.000387: Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base
p.000387: quarter of the preceding year, adjusted to the nearest 1⁄10 of 1 percent. For purposes of this paragraph, the
p.000387: term ‘‘base quarter’’, as used with respect to a year, means the calendar quarter ending on September 30 of such
p.000387: year and the price index for a base quarter is the arithmetical mean of such index for the 3 months
p.000387: comprising such quarter.
p.000387: (e) No person shall interfere with any officer, agent, or em- ployee of the Service in the performance of any
p.000387: duty imposed upon him by this section or by regulations made by authority thereof.
p.000387: (f) Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be
p.000387: punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such
p.000387: fine and imprisonment, in the discretion of the court.
...

p.000419: XVIII of the Social Security Act because of actions relating to the quality of the laboratory shall be
p.000419: suspended for the period the laboratory is so excluded.
p.000419: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000419:
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p.000419:
p.000421: 421
p.000421: PUBLIC HEALTH SERVICE ACT
p.000421: Sec. 353
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p.000421: January 30, 2020
p.000421: (4) IMPROPER REFERRALS.—Any laboratory that the Sec- retary determines intentionally refers its proficiency
p.000421: testing samples to another laboratory for analysis may have its certifi- cate revoked for at least one year and shall
p.000421: be subject to appro- priate fines and penalties as provided for in subsection (h).
p.000421: (j) INJUNCTIONS.—Whenever the Secretary has reason to be- lieve that continuation of any activity by a
p.000421: laboratory would con- stitute a significant hazard to the public health the Secretary may bring suit in the district
p.000421: court of the United States for the district in which such laboratory is situated to enjoin continuation of such
p.000421: activity. Upon proper showing, a temporary injunction or restrain- ing order against continuation of such activity
p.000421: pending issuance of a final order under this subsection shall be granted without bond by such court.
p.000421: (k) JUDICIAL REVIEW.—
p.000421: (1) PETITION.—Any laboratory which has had an inter- mediate sanction imposed under subsection (h) or has
p.000421: had its certificate suspended, revoked, or limited under subsection (i) may, at any time within 60 days
p.000421: after the date the action of the Secretary under subsection (i) or (h) becomes final, file a petition
p.000421: with the United States court of appeals for the circuit wherein the laboratory has its principal place of
p.000421: business for judicial review of such action. As soon as practicable after re- ceipt of the petition, the
p.000421: clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the
p.000421: Secretary for that purpose. As soon as practicable after receipt of the copy, the Secretary shall file in the
p.000421: court the record on which the action of the Secretary is based, as pro- vided in section 2112 of title 28,
p.000421: United States Code.
p.000421: (2) ADDITIONAL EVIDENCE.—If the petitioner applies to the court for leave to adduce additional evidence, and shows to
p.000421: the satisfaction of the court that such additional evidence is mate- rial and that there were reasonable grounds
...

p.001711: under this title.
p.001711: (2) FIXED INFRASTRUCTURE COSTS.—For purposes of para- graph (1), the term ‘‘fixed infrastructure costs’’ means,
p.001711: with re- spect to a Clinical Center of Excellence, the costs incurred by such Center that are not
p.001711: otherwise reimbursable by the WTC Program Administrator under section 3312(c) for patient eval- uation,
p.001711: monitoring, or treatment but which are needed to oper- ate the WTC program such as the costs involved in
p.001711: outreach to participants or recruiting participants, data collection and analysis, social services for
p.001711: counseling patients on other avail- able assistance outside the WTC program, and the develop- ment of
p.001711: treatment protocols. Such term does not include costs for new construction or other capital costs.
p.001711: (d) GAO ANALYSIS.—Not later than July 1, 2011, the Comp- troller General shall submit to the Committee on
p.001711: Energy and Com- merce of the House of Representatives and the Committee on Health, Education, Labor, and
p.001711: Pensions of the Senate an analysis on whether Clinical Centers of Excellence with which the WTC Program
p.001711: Administrator enters into a contract under this section have financial systems that will allow for the timely
p.001711: submission of claims data for purposes of section 3304 and subsections (a)(1)(F) and (b)(1)(B)(iii).
p.001711: SEC. 3306. ø42 U.S.C. 300mm–5¿ DEFINITIONS.
p.001711: In this title:
p.001711: (1) The term ‘‘aggravating’’ means, with respect to a health condition, a health condition that existed on
p.001711: September 11, 2001, and that, as a result of exposure to airborne toxins, any other hazard, or any other adverse
p.001711: condition resulting from the September 11, 2001, terrorist attacks, requires medical treat- ment that is (or
p.001711: will be) in addition to, more frequent than, or of longer duration than the medical treatment that would have been
p.001711: required for such condition in the absence of such expo- sure.
p.001711: (2) The term ‘‘certified-eligible WTC survivor’’ has the meaning given such term in section 3321(a)(2).
p.001711: (3) The terms ‘‘Clinical Center of Excellence’’ and ‘‘Data Center’’ have the meanings given such terms
p.001711: in section 3305.
p.001711: (4) The term ‘‘enrolled WTC responder’’ means a WTC re- sponder enrolled under section 3311(a)(3).
p.001711: (5) The term ‘‘initial health evaluation’’ includes, with re- spect to an individual, a medical and exposure
p.001711: history, a phys- ical examination, and additional medical testing as needed to evaluate whether the individual
p.001711: has a WTC-related health con- dition and is eligible for treatment under the WTC Program.
p.001711: (6) The term ‘‘list of WTC-related health conditions’’ means—
p.001711: (A) for WTC responders, the health conditions listed in section 3312(a)(3); and
p.001711: (B) for screening-eligible and certified-eligible WTC survivors, the health conditions listed in section 3322(b).
p.001711: (7) The term ‘‘New York City disaster area’’ means the area within New York City that is—
p.001711: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001711:
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p.001717: Before enrolling any individual as a WTC responder in the WTC Program under paragraph (3), the Administrator, in
p.001717: consultation with the Secretary of Home- land Security, shall determine whether the individual is on such list.
p.001717: (b) MONITORING BENEFITS.—
p.001717: (1) IN GENERAL.—In the case of an enrolled WTC re- sponder (other than one described in subsection
p.001717: (a)(2)(A)(ii)), the WTC Program shall provide for monitoring benefits that include monitoring consistent
p.001717: with protocols approved by the WTC Program Administrator and including clinical examina- tions and
p.001717: long-term health monitoring and analysis. In the case of an enrolled WTC responder who is an active
p.001717: member of the Fire Department of New York City, the responder shall receive such benefits as part of the
p.001717: individual’s periodic com- pany medical exams.
p.001717: (2) PROVISION OF MONITORING BENEFITS.—The monitoring benefits under paragraph (1) shall be provided through
p.001717: the Clinical Center of Excellence for the type of individual involved or, in the case of an individual residing
p.001717: outside the New York metropolitan area, under an arrangement under section 3313.
p.001717: SEC. 3312. ø42 U.S.C. 300mm–22¿ TREATMENT OF ENROLLED WTC RE- SPONDERS FOR WTC-RELATED HEALTH CONDITIONS.
p.001717: (a) WTC-RELATED HEALTH CONDITION DEFINED.—
p.001717: (1) IN GENERAL.—For purposes of this title, the term ‘‘WTC-related health condition’’ means a condition
p.001717: that—
p.001717: (A)(i) is an illness or health condition for which expo- sure to airborne toxins, any other hazard, or any
p.001717: other ad- verse condition resulting from the September 11, 2001, ter- rorist attacks, based on an examination by
p.001717: a medical pro- fessional with experience in treating or diagnosing the health conditions included in the
p.001717: applicable list of WTC-re- lated health conditions, is substantially likely to be a sig- nificant factor in
p.001717: aggravating, contributing to, or causing the illness or health condition, as determined under para- graph (2); or
p.001717: (ii) is a mental health condition for which such at- tacks, based on an examination by a medical
p.001717: professional with experience in treating or diagnosing the health condi- tions included in the applicable list of
p.001717: WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to,
p.001717: or causing the condition, as determined under paragraph (2); and
p.001717: (B) is included in the applicable list of WTC-related health conditions or—
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001717:
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p.001717: Sec. 3312 PUBLIC HEALTH SERVICE ACT 1718
p.001717: (i) with respect to a WTC responder, is provided certification of coverage under subsection (b)(2)(B)(iii); or
p.001717:
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p.001717: January 30, 2020
p.001717: (ii) with respect to a screening-eligible WTC sur- vivor or certified-eligible WTC survivor, is provided
p.001717: certification of coverage under subsection (b)(2)(B)(iii), as applied under section 3322(a).
p.001717: In the case of a WTC responder described in section 3311(a)(2)(A)(ii) (relating to a
p.001717: surviving immediate family member of a firefighter), such term does not include an illness or health condition
p.001717: described in subparagraph (A)(i).
p.001717: (2) DETERMINATION.—The determination under paragraph
p.001717: (1) or subsection (b) of whether the September 11, 2001, ter- rorist attacks were substantially likely
p.001717: to be a significant fac- tor in aggravating, contributing to, or causing an individual’s illness or
p.001717: health condition shall be made based on an assess- ment of the following:
p.001717: (A) The individual’s exposure to airborne toxins, any other hazard, or any other adverse condition
p.001717: resulting from the terrorist attacks. Such exposure shall be—
p.001717: (i) evaluated and characterized through the use of a standardized, population-appropriate questionnaire approved by
p.001717: the Director of the National Institute for Occupational Safety and Health; and
p.001717: (ii) assessed and documented by a medical profes- sional with experience in treating or diagnosing health conditions
p.001717: included on the list of WTC-related health conditions.
p.001717: (B) The type of symptoms and temporal sequence of symptoms. Such symptoms shall be—
p.001717: (i) assessed through the use of a standardized, population-appropriate medical questionnaire ap- proved
p.001717: by the Director of the National Institute for Oc- cupational Safety and Health and a medical examina- tion; and
p.001717: (ii) diagnosed and documented by a medical pro- fessional described in subparagraph (A)(ii).
p.001717: (3) LIST OF HEALTH CONDITIONS FOR WTC RESPONDERS.— The list of health conditions for WTC responders
p.001717: consists of the following:
p.001717: (A) AERODIGESTIVE DISORDERS.—
p.001717: (i) Interstitial lung diseases.
p.001717: (ii) Chronic respiratory disorder—fumes/vapors.
p.001717: (iii) Asthma.
p.001717: (iv) Reactive airways dysfunction syndrome (RADS).
p.001717: (v) WTC-exacerbated chronic obstructive pul- monary disease (COPD).
p.001717: (vi) Chronic cough syndrome.
p.001717: (vii) Upper airway hyperreactivity.
p.001717: (viii) Chronic rhinosinusitis.
p.001717: (ix) Chronic nasopharyngitis.
p.001717: (x) Chronic laryngitis.
p.001717: (xi) Gastroesophageal reflux disorder (GERD).
p.001717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001717:
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General/Other / Other Country

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p.000001: shall be deemed to have been suspended during the pendency of the civil action or proceeding under this
p.000001: section.
p.000001: (d) The Attorney General may compromise or settle any claim asserted in such civil action or proceeding in the
p.000001: manner provided in section 2677 of title 28 and with the same effect.
p.000001: (e) For purposes of this section, the provisions of section 2680(h) of title 28 shall not apply to
p.000001: assault or battery arising out of negligence in the performance of medical, surgical, dental, or re-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 27 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: lated functions, including the conduct of clinical studies or inves- tigations.
p.000001: (f) The Secretary or his designee may, to the extent that he deems appropriate, hold harmless or provide
p.000001: liability insurance for any officer or employee of the Public Health Service for damage for personal injury, including
p.000001: death, negligently caused by such officer or employee while acting within the scope of his office or employ-
p.000001: ment and as a result of the performance of medical, surgical, den- tal, or related functions, including the conduct of
p.000001: clinical studies or investigations, if such employee is assigned to a foreign country or detailed to a State or
p.000001: political subdivision thereof or to a non-profit institution, and if the circumstances are such as are likely
p.000001: to pre- clude the remedies of third persons against the United States de- scribed in section 2679(b) of
p.000001: title 28, for such damage or injury.
p.000001: (g)(1)(A) For purposes of this section and subject to the ap- proval by the Secretary of an application under
p.000001: subparagraph (D), an entity described in paragraph (4), and any officer, governing board member, or
p.000001: employee of such an entity, and any contractor of such an entity who is a physician or other licensed
p.000001: or certified health care practitioner (subject to paragraph (5)), shall be deemed to be an employee of the Public
p.000001: Health Service for a calendar year that begins during a fiscal year for which a transfer was made under
p.000001: subsection (k)(3) (subject to paragraph (3)). The remedy against the United States for an entity
p.000001: described in paragraph (4) and any officer, governing board member, employee, or contractor (subject to
p.000001: paragraph (5)) of such an entity who is deemed to be an employee of the Public Health Service pursuant
p.000001: to this para- graph shall be exclusive of any other civil action or proceeding to the same extent as the
p.000001: remedy against the United States is exclu- sive pursuant to subsection (a).
p.000001: (B) The deeming of any entity or officer, governing board mem- ber, employee, or contractor of the entity to be an
...

p.000439: provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or
p.000439: articles found to be so infected or con- taminated as to be sources of dangerous infection to human beings, and
p.000439: other measures, as in his judgment may be necessary.
p.000439: (b) Regulations prescribed under this section shall not provide for the apprehension, detention, or conditional
p.000439: release of individ- uals except for the purpose of preventing the introduction, trans- mission, or spread of
p.000439: such communicable diseases as may be speci- fied from time to time in Executive orders of the President upon
p.000439: the recommendation of the Secretary, in consultation with the Sur- geon General, 72.
p.000439: (c) Except as provided in subsection (d), regulations prescribed under this section, insofar as they provide for the
p.000439: apprehension, de- tention, examination, or conditional release of individuals, shall be
p.000439:
p.000439:
p.000439:
p.000439:
p.000439: January 30, 2020
p.000439: 72 The comma is so in law. See the amendment made by section 142(a)(1) of Public Law 107– 188 (116 Stat. 626).
p.000439: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000441: 441
p.000441: PUBLIC HEALTH SERVICE ACT
p.000441: Sec. 363
p.000441:
p.000441: applicable only to individuals coming into a State or possession from a foreign country or a possession.
p.000441: (d)(1) Regulations prescribed under this section may provide for the apprehension and examination of any
p.000441: individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be
p.000441: moving or about to move from a State to an- other State; or (B) to be a probable source of infection
p.000441: to individ- uals who, while infected with such disease in a qualifying stage, will be moving from a State
p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
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p.000809: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000811: 811
p.000811: PUBLIC HEALTH SERVICE ACT
p.000811: Sec. 498A
p.000811:
p.000811: title establishes express authority for such purpose and unless the Act making appropriations under such provision
p.000811: specifies that the amounts appropriated are available for such purpose.
p.000811: (2) Any grants, cooperative agreements, or contracts authorized in this title for the construction of facilities
p.000811: may be awarded only on a competitive basis.
p.000811: GIFTS
p.000811:
p.000811: SEC. 497. ø289f¿ The Secretary may, in accordance with sec- tion 231, accept conditional gifts for the
p.000811: National Institutes of Health or a national research institute or for the acquisition of grounds or for the
p.000811: erection, equipment, or maintenance of facilities for the National Institutes of Health or a national research
p.000811: insti- tute. Donations of $50,000 or over for the National Institutes of Health or a national research
p.000811: institute for carrying out the pur- poses of this title may be acknowledged by the establishment with- in the
p.000811: National Institutes of Health or a national research institute of suitable memorials to the donors.
p.000811:
p.000811: FETAL RESEARCH
p.000811: SEC. 498. ø289g¿ (a) The Secretary may not conduct or support any research or experimentation, in the United
p.000811: States or in any other country, on a nonviable living human fetus ex utero or a liv- ing human fetus ex
p.000811: utero for whom viability has not been ascertained unless the research or experimentation—
p.000811: (1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its
p.000811: survival to viabil- ity; or
p.000811: (2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or
p.000811: experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
p.000811: (b) In administering the regulations for the protection of human research subjects which—
p.000811: (1) apply to research conducted or supported by the Sec- retary;
p.000811: (2) involve living human fetuses in utero; and
p.000811: (3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
p.000811: or any successor to such regulations, the Secretary shall require that the risk standard (published in
p.000811: section 46.102(g) of such part
p.000811: 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and
p.000811: fetuses which are intended to be carried to term.
p.000811:
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p.000839: (C) the Center for Substance Abuse Prevention; and
p.000839: (D) the Center for Mental Health Services.
p.000839: Each such advisory council shall advise, consult with, and make recommendations to the Secretary and the
p.000839: Assistant Sec- retary or Director of the Administration or Center for which the advisory council is
p.000839: established concerning matters relating to the activities carried out by and through the Administration or Center and
p.000839: the policies respecting such activities.
p.000839: (2) FUNCTION AND ACTIVITIES.—An advisory council—
p.000839: (A)(i) may on the basis of the materials provided by the organization respecting activities conducted at
p.000839: the or- ganization, make recommendations to the Assistant Sec- retary or Director of the Administration or
p.000839: Center for which it was established respecting such activities;
p.000839: (ii) shall review applications submitted for grants and cooperative agreements for activities for which advisory
p.000839: council approval is required under section 504(d)(2) and recommend for approval applications for projects that
p.000839: show promise of making valuable contributions to the Adminis- tration’s mission; and
p.000839: (iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the or-
p.000839: ganization;
p.000839: (B) may collect, by correspondence or by personal in- vestigation, information as to studies and services that
p.000839: are being carried on in the United States or any other country as to the diseases, disorders, or other aspects
p.000839: of human health with respect to which the organization was estab- lished and with the approval of the
p.000839: Assistant Secretary or Director, whichever is appropriate, make such information available through appropriate
p.000839: publications for the benefit of public and private health entities and health professions personnel and for the
p.000839: information of the general public; and
p.000839:
p.000839:
p.000839:
p.000839:
p.000839: January 30, 2020
p.000839: (C) may appoint subcommittees and convene work- shops and conferences.
p.000839: (b) MEMBERSHIP.—
p.000839: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000839: Sec. 502 PUBLIC HEALTH SERVICE ACT 840
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p.000839: January 30, 2020
p.000839:
p.000839: (1) IN GENERAL.—Each advisory council shall consist of nonvoting ex officio members and not more than 12
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General/Other / Public Emergency

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p.000001: C:\XML\PHSA.BEL HOUSEP
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p.000001: 3 PUBLIC HEALTH SERVICE ACT Sec. 203
p.000001:
p.000001: Bureau of Medical Services, and (4) the Bureau of State Services, and the Agency for Health Care Policy
p.000001: and Research. 2 The Sec- retary is authorized and directed to assign to the Office of the Sec- retary, to the
p.000001: National Institutes of Health, to the Bureau of Med- ical Services, and to the Bureau of State Services, respectively,
p.000001: the several functions of the Service, and to establish within them such divisions, sections and other units as he
p.000001: may find necessary; and from time to time, abolish, transfer, and consolidate divisions, sec- tions, and other
p.000001: units and assign their functions and personnel in such manner as he may find necessary for efficient operation
p.000001: of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated,
p.000001: except with the approval of the Secretary. The National Institutes of Health shall be adminis- tered as a
p.000001: part of the field service. The Secretary may delegate to any officer or employee of the Service such of his
p.000001: powers and duties under this Act, except the making of regulations, as he may deem necessary or expedient.
p.000001: SEC. 203. ø204¿ COMMISSIONED CORPS AND READY RESERVE CORPS.
p.000001: (a) ESTABLISHMENT.—
p.000001: (1) IN GENERAL.—There shall be in the Service a commis- sioned Regular Corps and a Ready Reserve Corps
p.000001: for service in time of national emergency.
p.000001: (2) REQUIREMENT.—All commissioned officers shall be citi- zens of the United States and shall be appointed
p.000001: without re- gard to the civil-service laws and compensated without regard to the Classification Act of 1923, 3
p.000001: as amended.
p.000001: (3) APPOINTMENT.—Commissioned officers of the Ready Re- serve Corps shall be appointed by the President and
p.000001: commis- sioned officers of the Regular Corps shall be appointed by the President.
p.000001: (4) ACTIVE DUTY.—Commissioned officers of the Ready Re- serve Corps shall at all times be subject to call to
p.000001: active duty by the Surgeon General, including active duty for the purpose of training.
p.000001: (5) WARRANT OFFICERS.—Warrant officers may be ap- pointed to the Service for the purpose of
p.000001: providing support to the health and delivery systems maintained by the Service and any warrant officer appointed
p.000001: to the Service shall be consid- ered for purposes of this Act and title 37, United States Code, to be a
p.000001: commissioned officer within the Commissioned Corps of the Service.
p.000001: (b) ASSIMILATING RESERVE CORP OFFICERS INTO THE REGULAR CORPS.—Effective on the date of enactment of the
p.000001: Patient Protec- tion and Affordable Care Act, all individuals classified as officers in the Reserve Corps
p.000001: under this section (as such section existed on the day before the date of enactment of such Act) and serving
p.000001: on
p.000001:
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p.000001: January 30, 2020
p.000001: Although not established in this Act, the Centers for Disease Control and Prevention, the Health
p.000001: Resources and Services Administration, and the Agency for Toxic Substances and Dis- ease Registry are
p.000001: agencies of the Service.
p.000001: The Food and Drug Administration is also an agency of the Service.
p.000001: 2 So in law. See section 2008(g)(2) of Public Law 103–43 (107 Stat. 212). The term ‘‘the Agen- cy’’ probably should
p.000001: be preceded by ‘‘(5)’’, and the ‘‘and’’ before ‘‘(4)’’ probably should be struck. Further, Public Law
p.000001: 106–129 redesignated the Agency for Health Care Policy and Research as the Agency for Healthcare Research and Quality
p.000001: (see 113 Stat. 1653).
p.000001: 3 Civil service and classification laws are now codified to title 5, United States Code.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 203A PUBLIC HEALTH SERVICE ACT 4
p.000001:
p.000001: active duty shall be deemed to be commissioned officers of the Reg- ular Corps.
p.000001: (c) PURPOSE AND USE OF READY RESEARCH.—
p.000001: (1) PURPOSE.—The purpose of the Ready Reserve Corps is to fulfill the need to have additional Commissioned
p.000001: Corps per- sonnel available on short notice (similar to the uniformed serv- ice’s reserve program) to assist
p.000001: regular Commissioned Corps personnel to meet both routine public health and emergency response missions.
p.000001: (2) USES.—The Ready Reserve Corps shall—
p.000001: (A) participate in routine training to meet the general and specific needs of the Commissioned Corps;
p.000001: (B) be available and ready for involuntary calls to ac- tive duty during national emergencies and public
p.000001: health crises, similar to the uniformed service reserve personnel;
p.000001: (C) be available for backfilling critical positions left va- cant during deployment of active duty
p.000001: Commissioned Corps members, as well as for deployment to respond to public health emergencies, both foreign
p.000001: and domestic; and
p.000001: (D) be available for service assignment in isolated, hardship, and medically underserved communities (as
p.000001: de- fined in section 799B) to improve access to health services.
p.000001: (d) FUNDING.—For the purpose of carrying out the duties and responsibilities of the Commissioned Corps
p.000001: under this section, there are authorized to be appropriated $5,000,000 for each of fis- cal years
p.000001: 2010 through 2014 for recruitment and training and
p.000001: $12,500,000 for each of fiscal years 2010 through 2014 for the Ready Reserve Corps.
p.000001: SEC. 203A. ø204a¿ DEPLOYMENT READINESS.
p.000001: (a) READINESS REQUIREMENTS FOR COMMISSIONED CORPS OFFI-
p.000001: CERS.—
p.000001:
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p.000001: January 30, 2020
p.000001: (1) IN GENERAL.—The Secretary, with respect to members of the following Corps components, shall establish
p.000001: require- ments, including training and medical examinations, to ensure the readiness of such components to
p.000001: respond to urgent or emergency public health care needs that cannot otherwise be met at the Federal, State,
p.000001: and local levels:
p.000001: (A) Active duty Regular Corps.
p.000001: (B) Active Reserves.
p.000001: (2) ANNUAL ASSESSMENT OF MEMBERS.—The Secretary shall annually determine whether each member of the
p.000001: Corps meets the applicable readiness requirements established under paragraph (1).
p.000001: (3) FAILURE TO MEET REQUIREMENTS.—A member of the Corps who fails to meet or maintain the readiness
p.000001: require- ments established under paragraph (1) or who fails to comply with orders to respond to an urgent or
p.000001: emergency public health care need shall, except as provided in paragraph (4), in accord- ance with procedures
p.000001: established by the Secretary, be subject to disciplinary action as prescribed by the Secretary.
p.000001: (4) WAIVER OF REQUIREMENTS.—
p.000001: (A) IN GENERAL.—The Secretary may waive one or more of the requirements established under paragraph (1)
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000001: 5 PUBLIC HEALTH SERVICE ACT Sec. 203A
p.000001:
p.000001: for an individual who is not able to meet such require- ments because of—
p.000001: (i) a disability;
p.000001: (ii) a temporary medical condition; or
p.000001: (iii) any other extraordinary limitation as deter- mined by the Secretary.
p.000001: (B) REGULATIONS.—The Secretary shall promulgate regulations under which a waiver described in subpara-
p.000001: graph (A) may be granted.
p.000001: (5) URGENT OR EMERGENCY PUBLIC HEALTH CARE NEED.— For purposes of this section and section 214, the term
p.000001: ‘‘urgent or emergency public health care need’’ means a health care need, as determined by the Secretary,
p.000001: arising as the result of—
p.000001: (A) a national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et
p.000001: seq.);
p.000001: (B) an emergency or major disaster declared by the President under the Robert T. Stafford Disaster Relief and
p.000001: Emergency Assistance Act (42 U.S.C. 5121 et seq.);
p.000001: (C) a public health emergency declared by the Sec- retary under section 319 of this Act; or
p.000001: (D) any emergency that, in the judgment of the Sec- retary, is appropriate for the deployment of
p.000001: members of the Corps.
p.000001: (b) CORPS MANAGEMENT FOR DEPLOYMENT.—The Secretary shall—
p.000001: (1) organize members of the Corps into units for rapid de-
p.000001: ployment by the Secretary to respond to urgent or emergency public health care needs;
p.000001: (2) establish appropriate procedures for the command and control of units or individual members of the
p.000001: Corps that are deployed at the direction of the President or the Secretary in response to an urgent or
p.000001: emergency public health care need of national, State or local significance;
p.000001: (3) ensure that members of the Corps are trained, equipped and otherwise prepared to fulfill
p.000001: their public health and emergency response roles; and
p.000001: (4) ensure that deployment planning takes into account—
p.000001: (A) any deployment exemptions that may be granted by the Secretary based on the unique requirements of
p.000001: an agency and an individual’s functional role in such agency; and
p.000001:
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p.000001: January 30, 2020
p.000001: (B) the nature of the urgent or emergency public health care need.
p.000001: (c) DEPLOYMENT OF DETAILED OR ASSIGNED OFFICERS.—For purposes of pay, allowances, and benefits of a
p.000001: Commissioned Corps officer who is detailed or assigned to a Federal entity, the deploy- ment of such
p.000001: officer by the Secretary in response to an urgent or emergency public health care need shall be deemed
p.000001: to be an au- thorized activity of the Federal entity to which the officer is de- tailed or assigned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 204 PUBLIC HEALTH SERVICE ACT 6
p.000001: SURGEON GENERAL
p.000001: SEC. 204. ø205¿ The Surgeon General shall be appointed from the Regular Corps for a four-year term by the
p.000001: President by and with the advice and consent of the Senate. The Surgeon General shall be appointed from
p.000001: individuals who (1) are members of the Regular Corps, and (2) have specialized training or significant
p.000001: ex- perience in public health programs. Upon the expiration of such term, the Surgeon General, unless
p.000001: reappointed, shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he
p.000001: not served as Surgeon General.
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p.000001: both) to the same grade effective on the same day, relative seniority shall be determined in accordance with
p.000001: regulations of the President.
p.000001: (2) In the case of an officer originally appointed in the Regular Corps to the grade of assistant or above, his
p.000001: seniority in the grade to which appointed shall be determined after inclusion, as service in such grade, of
p.000001: any active service in such grade or in any higher grade in the Reserve Corps, but (if the appointment is to the grade
p.000001: of senior assistant or above) only to the extent of whichever of the following is greater: (A) His active service
p.000001: in such grade or any higher grade in the Reserve Corps after the first day on which, under regulations
p.000001: in effect on the date of his appointment to the Regular Corps, he had the training and experience
p.000001: necessary for such appointment, or (B) the excess of his total active service in the Reserve Corps (above the
p.000001: grade of junior assistant) over three years if his appointment in the Regular Corps is to the senior
p.000001: as- sistant grade, over ten years if the appointment is to the full grade, or over seventeen years if the
p.000001: appointment is to the senior grade.
p.000001: (k) Any commissioned officer of the Regular Corps in any grade
p.000001: in any professional category may be recommended to the President for temporary promotion to fill a vacancy in
p.000001: any higher grade in such category, up to and including the director grade. In time of war, or of
p.000001: national emergency proclaimed by the President, any commissioned officer of the Regular Corps in any grade in any
p.000001: pro- fessional category may be recommended to the President for pro- motion to any higher grade in such
p.000001: category, up to and including the director grade, whether or not a vacancy exists in such grade. The
p.000001: selection of officers to be recommended for temporary pro- motions shall be made in accordance with regulations
p.000001: of the Presi- dent. Promotion of an officer recommended pursuant to this sub- section may be made without
p.000001: regard to length of service, without examination, and without vacating his permanent appointment, and shall
p.000001: carry with it the pay and allowances of the grade to which promoted. Such promotions may be terminated at
p.000001: any time, as may be directed by the President.
p.000001: (l) Whenever the number of officers of the Regular Corps on ac- tive duty, plus the number of officers of the
p.000001: Reserve Corps who have been on active duty for thirty days or more, exceeds the au- thorized strength
p.000001: of the Regular Corps, the Secretary shall deter- mine the requirements of the Service in each grade in
p.000001: each cat- egory, based upon the total number of officers so serving on active duty and the tasks being performed
p.000001: by the Service; and the Sur- geon General shall thereupon assign each officer of the Reserve Corps on
p.000001: active duty to a professional category. If the Secretary finds that the number of officers fixed under section
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p.000001: (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the
p.000001: Service except that, in accordance with regulations such personnel may be placed on leave without pay and paid
p.000001: by the State, subdivision, or institution to which they are detailed. In the case of detail of
p.000001: personnel under subsections (b) or (c) to be paid from applicable Service appropria- tions, the Secretary may
p.000001: condition such detail on an agreement by the State, subdivision, or institution concerned that such State,
p.000001: subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by
p.000001: the Service. The services of personnel while detailed pursuant to this section shall be considered as having
p.000001: been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa-
p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
p.000001: may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned
p.000001: under this section to an entity outside of the Department of Health and Human Services for service under
p.000001: the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined
p.000001: in section 203A(a)(5)).
p.000001:
p.000001: REGULATIONS
p.000001: SEC. 215. ø216¿ (a) The President shall from time to time pre- scribe regulations with respect to the
p.000001: appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances
p.000001: (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service.
p.000001: (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall
p.000001: promulgate all other regulations necessary to the administration of the Service, includ- ing regulations
p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
p.000001:
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p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
p.000001: SEC. 216. ø217¿ In time of war, or of emergency proclaimed by the President, he may utilize the Service to such
p.000001: extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency
p.000001: involving the national defense pro-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 217 PUBLIC HEALTH SERVICE ACT 22
p.000001:
p.000001: claimed by the President, he may by Executive order declare the commissioned corps of the Service to be
p.000001: a military service. Upon such declaration, and during the period of such war or such emer- gency or such part
p.000001: thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the
p.000001: land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President,
p.000001: be subject to the Uniform Code of Military Justice, and (c) shall continue to operate as part of the
p.000001: Service except to the extent that the President may direct as Com- mander in Chief.
p.000001:
p.000001: NATIONAL ADVISORY COUNCILS
p.000001: SEC. 217. ø218¿ (a) Within 120 days of the date of the enact- ment of this subsection, the Secretary
p.000001: shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred
p.000001: to as the Council) which shall advise, consult with, and make recommendations to, the Secretary on matters con-
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p.000001: January 30, 2020
p.000001: (A) The service is provided to the individual at a free clin- ic, or through offsite programs or events carried out by
p.000001: the free clinic.
p.000001: (B) The free clinic is sponsoring the health care practi- tioner pursuant to paragraph (5)(C).
p.000001: (C) The service is a qualifying health service (as defined in paragraph (4)).
p.000001: (D) Neither the health care practitioner nor the free clinic receives any compensation for the service from the
p.000001: individual or from any third-party payor (including reimbursement under any insurance policy or health plan, or
p.000001: under any Federal or State health benefits program). With respect to compliance with such condition:
p.000001: (i) The health care practitioner may receive repayment from the free clinic for reasonable expenses incurred by
p.000001: the health care practitioner in the provision of the service to the individual.
p.000001: (ii) The free clinic may accept voluntary donations for the provision of the service by the health care practitioner to
p.000001: the individual.
p.000001: (E) Before the service is provided, the health care practi- tioner or the free clinic provides written
p.000001: notice to the indi- vidual of the extent to which the legal liability of the health care practitioner
p.000001: is limited pursuant to this subsection (or in the case of an emergency, the written notice is provided to the
p.000001: individual as soon after the emergency as is practicable). If the individual is a minor or is otherwise legally
p.000001: incompetent, the condition under this subparagraph is that the written notice be provided to a legal guardian or other
p.000001: person with legal respon- sibility for the care of the individual.
p.000001: (F) At the time the service is provided, the health care practitioner is licensed or certified in accordance
p.000001: with applica- ble law regarding the provision of the service.
p.000001: (3)(A) For purposes of this subsection, the term ‘‘free clinic’’ means a health care facility operated by a
p.000001: nonprofit private entity meeting the following requirements:
p.000001: (i) The entity does not, in providing health services through the facility, accept reimbursement
p.000001: from any third- party payor (including reimbursement under any insurance policy or health plan, or under
p.000001: any Federal or State health benefits program).
p.000001: (ii) The entity, in providing health services through the fa- cility, either does not impose charges on the
p.000001: individuals to whom the services are provided, or imposes a charge according to the ability of the individual involved
p.000001: to pay the charge.
p.000001: (iii) The entity is licensed or certified in accordance with applicable law regarding the provision of health
p.000001: services.
p.000001: (B) With respect to compliance with the conditions under sub- paragraph (A), the entity involved may accept voluntary
p.000001: donations for the provision of services.
p.000001: (4) For purposes of this subsection, the term ‘‘qualifying health service’’ means any medical assistance required or
p.000001: authorized to be
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p.000001: of 1996—
p.000001: (I) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and
p.000001: consider ap- plications submitted pursuant to paragraph (5)(C); and
p.000001: (II) reports under paragraph (6)(C) may be submitted to the Congress.
p.000001: (ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of paragraph (6), if an
p.000001: estimate under sub- paragraph (C) of such paragraph has not been made for the cal- endar year beginning
p.000001: in such fiscal year, the transfer under sub- paragraph (D) of such paragraph shall be made
p.000001: notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount
p.000001: of such appropriation.
p.000001: (p) ADMINISTRATION OF SMALLPOX COUNTERMEASURES BY
p.000001: HEALTH PROFESSIONALS.—
p.000001: (1) IN GENERAL.—For purposes of this section, and subject to other provisions of this subsection, a covered person
p.000001: shall be deemed to be an employee of the Public Health Service with respect to liability arising out of
p.000001: administration of a covered countermeasure against smallpox to an individual during the effective period of
p.000001: a declaration by the Secretary under para- graph (2)(A).
p.000001: (2) DECLARATION BY SECRETARY CONCERNING COUNTER- MEASURE AGAINST SMALLPOX.—
p.000001: (A) AUTHORITY TO ISSUE DECLARATION.—
p.000001: (i) IN GENERAL.—The Secretary may issue a dec- laration, pursuant to this paragraph, concluding that an
p.000001: actual or potential bioterrorist incident or other ac- tual or potential public health emergency makes ad-
p.000001: visable the administration of a covered counter- measure to a category or categories of individuals.
p.000001: (ii) COVERED COUNTERMEASURE.—The Secretary shall specify in such declaration the substance or sub- stances
p.000001: that shall be considered covered counter- measures (as defined in paragraph (7)(A)) for purposes of
p.000001: administration to individuals during the effective period of the declaration.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 37 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: (iii) EFFECTIVE PERIOD.—The Secretary shall specify in such declaration the beginning and ending
p.000001: dates of the effective period of the declaration, and may subsequently amend such declaration to shorten
p.000001: or extend such effective period, provided that the new closing date is after the date when the declaration is
p.000001: amended.
p.000001: (iv) PUBLICATION.—The Secretary shall promptly publish each such declaration and amendment in the Federal
p.000001: Register.
p.000001: (B) LIABILITY OF UNITED STATES ONLY FOR ADMINISTRA- TIONS WITHIN SCOPE OF DECLARATION.—Except as provided in
p.000001: paragraph (5)(B)(ii), the United States shall be liable under this subsection with respect to a claim
p.000001: arising out of the administration of a covered countermeasure to an individual only if—
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p.000001: fiscal year.
p.000001: (ii) Subsection (k)(1)(B) applies to the estimate under clause (i) regarding health professional volunteers to the same
p.000001: extent and in the same manner as such subsection applies to the estimate under such subsection regarding officers,
p.000001: governing board members, em- ployees, and contractors of entities described in subsection (g)(4).
p.000001: (iii) The report shall include a summary of the data relied upon for the estimate in clause (i), including the
p.000001: number of claims filed and paid from the previous calendar year.
p.000001: (C) Not later than December 31 of each fiscal year, the Sec- retary shall transfer from the fund under
p.000001: subsection (k)(2) to the appropriate accounts in the Treasury an amount equal to the esti- mate made under
p.000001: subparagraph (B) for the calendar year begin- ning in such fiscal year, subject to the extent of
p.000001: amounts in the fund.
p.000001: (5)(A) This subsection shall take effect on October 1, 2017, ex- cept as provided in subparagraph (B) and paragraph
p.000001: (6).
p.000001: (B) Effective on the date of the enactment of this subsection—
p.000001: (i) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and
p.000001: consider ap- plications submitted pursuant to paragraph (3)(B); and
p.000001: (ii) reports under paragraph (4)(B) may be submitted to Congress.
p.000001: (6) Beginning on October 1, 2022, this subsection shall cease to have any force or effect.
p.000001: SEC. 225. ø234¿ HEALTH CARE PROFESSIONALS ASSISTING DURING A PUBLIC HEALTH EMERGENCY.
p.000001: (a) LIMITATION ON LIABILITY.—Notwithstanding any other pro- vision of law, a health care professional who is a
p.000001: member of the Medical Reserve Corps under section 2813 or who is included in the Emergency System
p.000001: for Advance Registration of Volunteer Health Professionals under section 319I and who—
p.000001: (1) is responding—
p.000001: (A) to a public health emergency determined under section 319(a), during the initial period of not more
p.000001: than
p.000001: 90 days (as determined by the Secretary) of the public health emergency determination (excluding any period
p.000001: cov- ered by a renewal of such determination); or
p.000001: (B) to a major disaster or an emergency as declared by the President under section 401 of the Robert T.
p.000001: Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: Sec. 225 PUBLIC HEALTH SERVICE ACT 44
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p.000001: January 30, 2020
p.000001:
p.000001: 5170) or under section 201 of the National Emergencies Act (50 U.S.C. 1621) during the initial period of such
p.000001: dec- laration;
p.000001: (2) is alleged to be liable for an act or omission—
p.000001: (A) during the initial period of a determination or dec- laration described in paragraph (1) and related to the
p.000001: treatment of individuals in need of health care services due to such public health emergency, major
p.000001: disaster, or emergency;
p.000001: (B) in the State or States for which such determina- tion or declaration is made;
p.000001: (C) in the health care professional’s capacity as a member of the Medical Reserve Corps or a professional in-
p.000001: cluded in the Emergency System for Advance Registration of Volunteer Health Professionals under section 319I;
p.000001: and
p.000001: (D) in the course of providing services that are within the scope of the license, registration, or certification of the
p.000001: professional, as defined by the State of licensure, registra- tion, or certification; and
p.000001: (3) prior to the rendering of such act or omission, was au- thorized by the State’s authorization of deploying
p.000001: such State’s Emergency System for Advance Registration of Volunteer Health Professionals described in
p.000001: section 319I or the Medical Reserve Corps established under section 2813, to provide health care
p.000001: services,
p.000001: shall be subject only to the State liability laws of the State in which such act or omission occurred,
p.000001: in the same manner and to the same extent as a similar health care professional who is a resi- dent of such State
p.000001: would be subject to such State laws, except with respect to the licensure, registration, and certification of such
p.000001: indi- vidual.
p.000001: (b) VOLUNTEER PROTECTION ACT.—Nothing in this section shall be construed to affect an individual’s right to
p.000001: protections under the Volunteer Protection Act of 1997.
p.000001: (c) PREEMPTION.—This section shall supersede the laws of any State that would subject a health care professional
p.000001: described in subsection (a) to the liability laws of any State other than the State liability laws to which such
p.000001: individual is subject pursuant to such subsection.
p.000001: (d) DEFINITIONS.—In this section:
p.000001: (1) The term ‘‘health care professional’’ means an indi- vidual licensed, registered, or certified under
p.000001: Federal or State laws or regulations to provide health care services.
p.000001: (2) The term ‘‘health care services’’ means any services provided by a health care professional, or by
p.000001: any individual working under the supervision of a health care professional, that relate to—
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p.000017: Appropriations for carrying out the purposes of this Act shall not be used in a manner inconsistent
p.000017: with the Assisted Suicide Funding Restriction Act of 1997. 20
p.000017:
p.000017: RECOMMENDATIONS AND GUIDELINES REGARDING AUTOMATED EXTERNAL DEFIBRILLATORS FOR FEDERAL BUILDINGS
p.000017: SEC. 247. ø238p¿ (a) GUIDELINES ON PLACEMENT.—The Sec-
p.000017: retary shall establish guidelines with respect to placing automated external defibrillator devices in Federal
p.000017: buildings. Such guidelines shall take into account the extent to which such devices may be used by lay
p.000017: persons, the typical number of employees and visitors in the buildings, the extent of the need for
p.000017: security measures re- garding the buildings, buildings or portions of buildings in which there are special
p.000017: circumstances such as high electrical voltage or extreme heat or cold, and such other factors as the Secretary
p.000017: deter- mines to be appropriate.
p.000017: (b) RELATED RECOMMENDATIONS.—The Secretary shall publish in the Federal Register the recommendations
p.000017: of the Secretary on the appropriate implementation of the placement of automated ex- ternal defibrillator devices
p.000017: under subsection (a), including proce- dures for the following:
p.000017: (1) Implementing appropriate training courses in the use of such devices, including the role of
p.000017: cardiopulmonary resus- citation.
p.000017: (2) Proper maintenance and testing of the devices.
p.000017: (3) Ensuring coordination with appropriate licensed profes- sionals in the oversight of training of the devices.
p.000017: (4) Ensuring coordination with local emergency medical systems regarding the placement and incidents of
p.000017: use of the devices.
p.000017: (c) CONSULTATIONS; CONSIDERATION OF CERTAIN RECOMMENDA-
p.000017: TIONS.—In carrying out this section, the Secretary shall—
p.000017: (1) consult with appropriate public and private entities;
p.000017: (2) consider the recommendations of national and local public-health organizations for improving the
p.000017: survival rates of individuals who experience cardiac arrest in nonhospital set- tings by minimizing the
p.000017: time elapsing between the onset of
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 20 Public Law 105–12 (111 Stat. 23).
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
p.000017:
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p.000017: 57 PUBLIC HEALTH SERVICE ACT Sec. 248
p.000017:
p.000017: cardiac arrest and the initial medical response, including defibrillation as necessary; and
p.000017: (3) consult with and counsel other Federal agencies where such devices are to be used.
p.000017: (d) DATE CERTAIN FOR ESTABLISHING GUIDELINES AND REC- OMMENDATIONS.—The Secretary shall comply with
p.000017: this section not later than 180 days after the date of the enactment of the Cardiac Arrest Survival Act of 2000.
p.000017: (e) DEFINITIONS.—For purposes of this section:
p.000017: (1) The term ‘‘automated external defibrillator device’’ has the meaning given such term in section 248.
p.000017: (2) The term ‘‘Federal building’’ includes a building or por- tion of a building leased or rented by a Federal agency,
p.000017: and in- cludes buildings on military installations of the United States.
p.000017:
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p.000017: January 30, 2020
p.000017: LIABILITY REGARDING EMERGENCY USE OF AUTOMATED EXTERNAL DEFIBRILLATORS
p.000017: SEC. 248. ø238q¿ (a) GOOD SAMARITAN PROTECTIONS REGARD-
p.000017: ING AEDS.—Except as provided in subsection (b), any person who uses or attempts to use an automated
p.000017: external defibrillator device on a victim of a perceived medical emergency is immune from civil liability for any
p.000017: harm resulting from the use or attempted use of such device; and in addition, any person who acquired
p.000017: the device is immune from such liability, if the harm was not due to the fail- ure of such acquirer of the device—
p.000017: (1) to notify local emergency response personnel or other appropriate entities of the most recent placement of
p.000017: the device within a reasonable period of time after the device was placed;
p.000017: (2) to properly maintain and test the device; or
p.000017: (3) to provide appropriate training in the use of the device to an employee or agent of the acquirer when the employee
p.000017: or agent was the person who used the device on the victim, except that such requirement of training does not apply if—
p.000017: (A) the employee or agent was not an employee or agent who would have been reasonably expected to use the
p.000017: device; or
p.000017: (B) the period of time elapsing between the engage- ment of the person as an employee or agent and the occur-
p.000017: rence of the harm (or between the acquisition of the device and the occurrence of the harm, in any case in
p.000017: which the device was acquired after such engagement of the person) was not a reasonably sufficient period in
p.000017: which to provide the training.
p.000017: (b) INAPPLICABILITY OF IMMUNITY.—Immunity under subsection
p.000017: (a) does not apply to a person if—
p.000017: (1) the harm involved was caused by willful or criminal misconduct, gross negligence, reckless misconduct,
p.000017: or a con- scious, flagrant indifference to the rights or safety of the victim who was harmed;
p.000017: (2) the person is a licensed or certified health professional who used the automated external defibrillator device
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p.000017: acting within the scope of the employ- ment or agency of the employee or agent; or
p.000017: (4) the person is an acquirer of the device who leased the device to a health care entity (or who
p.000017: otherwise provided the device to such entity for compensation without selling the de- vice to the
p.000017: entity), and the harm was caused by an employee or agent of the entity who used the device while acting within
p.000017: the scope of the employment or agency of the employee or agent.
p.000017: (c) RULES OF CONSTRUCTION.—
p.000017: (1) IN GENERAL.—The following applies with respect to this section:
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p.000017: January 30, 2020
p.000017: (A) This section does not establish any cause of action, or require that an automated external defibrillator
p.000017: device be placed at any building or other location.
p.000017: (B) With respect to a class of persons for which this section provides immunity from civil liability,
p.000017: this section supersedes the law of a State only to the extent that the State has no statute or regulations
p.000017: that provide persons in such class with immunity for civil liability arising from the use by such persons of automated
p.000017: external defibrillator de- vices in emergency situations (within the meaning of the State law or regulation
p.000017: involved).
p.000017: (C) This section does not waive any protection from li- ability for Federal officers or employees under—
p.000017: (i) section 224; or
p.000017: (ii) sections 1346(b), 2672, and 2679 of title 28, United States Code, or under alternative benefits pro- vided
p.000017: by the United States where the availability of such benefits precludes a remedy under section
p.000017: 1346(b) of title 28.
p.000017: (2) CIVIL ACTIONS UNDER FEDERAL LAW.—
p.000017: (A) IN GENERAL.—The applicability of subsections (a) and (b) includes applicability to any action for civil
p.000017: liability described in subsection (a) that arises under Federal law.
p.000017: (B) FEDERAL AREAS ADOPTING STATE LAW.—If a geo- graphic area is under Federal jurisdiction and is
p.000017: located within a State but out of the jurisdiction of the State, and if, pursuant to Federal law, the law of the State
p.000017: applies in such area regarding matters for which there is no applica- ble Federal law, then an action for civil
p.000017: liability described in subsection (a) that in such area arises under the law of the State is subject to
p.000017: subsections (a) through (c) in lieu of any related State law that would apply in such area in the absence of this
p.000017: subparagraph.
p.000017: (d) FEDERAL JURISDICTION.—In any civil action arising under State law, the courts of the State involved
p.000017: have jurisdiction to apply the provisions of this section exclusive of the jurisdiction of the courts of
p.000017: the United States.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 59 PUBLIC HEALTH SERVICE ACT Sec. 261
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p.000017: January 30, 2020
p.000017: (e) DEFINITIONS.—
p.000017: (1) PERCEIVED MEDICAL EMERGENCY.—For purposes of this section, the term ‘‘perceived medical emergency’’ means
p.000017: cir- cumstances in which the behavior of an individual leads a rea- sonable person to believe that the individual is
p.000017: experiencing a life-threatening medical condition that requires an immediate medical response regarding the heart
p.000017: or other cardiopulmonary functioning of the individual.
p.000017: (2) OTHER DEFINITIONS.—For purposes of this section:
p.000017: (A) The term ‘‘automated external defibrillator device’’ means a defibrillator device that—
p.000017: (i) is commercially distributed in accordance with the Federal Food, Drug, and Cosmetic Act;
p.000017: (ii) is capable of recognizing the presence or ab- sence of ventricular fibrillation, and is capable of
p.000017: de- termining without intervention by the user of the de- vice whether defibrillation should be performed;
p.000017: (iii) upon determining that defibrillation should be performed, is able to deliver an electrical shock to an
p.000017: individual; and
p.000017: (iv) in the case of a defibrillator device that may be operated in either an automated or a manual mode, is
p.000017: set to operate in the automated mode.
p.000017: (B)(i) The term ‘‘harm’’ includes physical, nonphysical, economic, and noneconomic losses.
p.000017: (ii) The term ‘‘economic loss’’ means any pecuniary loss resulting from harm (including the loss of earnings or
p.000017: other benefits related to employment, medical expense loss, replacement services loss, loss due to
p.000017: death, burial costs, and loss of business or employment opportunities) to the extent recovery for such loss is allowed
p.000017: under applica- ble State law.
p.000017: (iii) The term ‘‘noneconomic losses’’ means losses for physical and emotional pain, suffering,
p.000017: inconvenience, physical impairment, mental anguish, disfigurement, loss of enjoyment of life, loss of society and
p.000017: companionship, loss of consortium (other than loss of domestic service), hedonic damages, injury to reputation and
p.000017: all other nonpecuniary losses of any kind or nature.
p.000017: PART C—SMALLPOX EMERGENCY PERSONNEL PROTECTION
p.000017: SEC. 261. ø239¿ GENERAL PROVISIONS.
p.000017: (a) DEFINITIONS.—For purposes of this part:
p.000017: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means a covered countermeasure as specified in a
p.000017: Declaration made pursuant to section 224(p).
p.000017: (2) COVERED INDIVIDUAL.—The term ‘‘covered individual’’ means an individual—
p.000017: (A) who is a health care worker, law enforcement offi- cer, firefighter, security personnel, emergency medical per-
p.000017: sonnel, other public safety personnel, or support personnel for such occupational specialities;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 261 PUBLIC HEALTH SERVICE ACT 60
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p.000017: (B) who is or will be functioning in a role identified in a State, local, or Department of Health and Human
p.000017: Serv- ices smallpox emergency response plan (as defined in para- graph (7)) approved by the Secretary;
p.000017: (C) who has volunteered and been selected to be a member of a smallpox emergency response plan
p.000017: described in subparagraph (B) prior to the time at which the Sec- retary publicly announces that an
p.000017: active case of smallpox has been identified either within or outside of the United States; and
p.000017: (D) to whom a smallpox vaccine is administered pur- suant to such approved plan during the effective period of
p.000017: the Declaration (including the portion of such period before the enactment of this part).
p.000017: (3) COVERED INJURY.—The term ‘‘covered injury’’ means an injury, disability, illness, condition, or death (other
p.000017: than a minor injury such as minor scarring or minor local reaction) determined, pursuant to the procedures
p.000017: established under sec- tion 262, to have been sustained by an individual as the direct result of—
p.000017: (A) administration to the individual of a covered coun- termeasure during the effective period of the
p.000017: Declaration; or
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p.000017: (B) accidental vaccinia inoculation of the individual in circumstances in which—
p.000017: (i) the vaccinia is contracted during the effective period of the Declaration or within 30 days after
p.000017: the end of such period;
p.000017: (ii) smallpox vaccine has not been administered to the individual; and
p.000017: (iii) the individual has been in contact with an in- dividual who is (or who was accidentally inoculated by) a
p.000017: covered individual.
p.000017: (4) DECLARATION.—The term ‘‘Declaration’’ means the Dec- laration Regarding Administration of Smallpox
p.000017: Counter- measures issued by the Secretary on January 24, 2003, and published in the Federal Register on
p.000017: January 28, 2003.
p.000017: (5) EFFECTIVE PERIOD OF THE DECLARATION.—The term ‘‘ef- fective period of the Declaration’’ means the
p.000017: effective period specified in the Declaration, unless extended by the Secretary.
p.000017: (6) ELIGIBLE INDIVIDUAL.—The term ‘‘eligible individual’’ means an individual who is (as determined in accordance
p.000017: with section 262)—
p.000017: (A) a covered individual who sustains a covered injury in the manner described in paragraph (3)(A); or
p.000017: (B) an individual who sustains a covered injury in the manner described in paragraph (3)(B).
p.000017: (7) SMALLPOX EMERGENCY RESPONSE PLAN.—The term ‘‘smallpox emergency response plan’’ or ‘‘plan’’
p.000017: means a re- sponse plan detailing actions to be taken in preparation for a possible smallpox-related
p.000017: emergency during the period prior to the identification of an active case of smallpox either within or outside the
p.000017: United States.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 61 PUBLIC HEALTH SERVICE ACT Sec. 262
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p.000017: January 30, 2020
p.000017: (b) VOLUNTARY PROGRAM.—The Secretary shall ensure that a State, local, or Department of Health and Human
p.000017: Services plan to vaccinate individuals that is approved by the Secretary establishes procedures to ensure,
p.000017: consistent with the Declaration and any ap- plicable guidelines of the Centers for Disease Control and
p.000017: Preven- tion, that—
p.000017: (1) potential participants are educated with respect to con- traindications, the voluntary nature of the program,
p.000017: and the availability of potential benefits and compensation under this part;
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p.000017: agency head admin- istering such Act or provisions through a Memorandum of Agree- ment under subsection
p.000017: (a)) may promulgate such implementing regulations as may be found necessary and appropriate. Initial im- plementing
p.000017: regulations may be interim final regulations.
p.000017: SEC. 268. ø239g¿ AUTHORIZATION OF APPROPRIATIONS.
p.000017: For the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for
p.000017: each of the fiscal years 2003 through 2007, to remain available until expended, including administrative costs and
p.000017: costs of provision and payment of benefits. The Secretary’s payment of any benefit under section 264,
p.000017: 265, or 266 shall be subject to the availability of appropria- tions under this section.
p.000017: SEC. 269. ø239h¿ RELATIONSHIP TO OTHER LAWS.
p.000017: Except as explicitly provided herein, nothing in this part shall be construed to override or limit any rights an
p.000017: individual may have to seek compensation, benefits, or redress under any other provi- sion of Federal or State
p.000017: law.
p.000017:
p.000017: PART D—UNITED STATES PUBLIC HEALTH SCIENCES TRACK
p.000017: SEC. 271. ø239l¿ ESTABLISHMENT.
p.000017: (a) UNITED STATES PUBLIC HEALTH SERVICES TRACK.—
p.000017: (1) IN GENERAL.—There is hereby authorized to be estab- lished a United States Public Health Sciences
p.000017: Track (referred to in this part as the ‘‘Track’’), at sites to be selected by the Secretary, with
p.000017: authority to grant appropriate advanced de- grees in a manner that uniquely emphasizes team-based serv- ice,
p.000017: public health, epidemiology, and emergency preparedness and response. It shall be so organized as to
p.000017: graduate not less than—
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p.000017: January 30, 2020
p.000017: (A) 150 medical students annually, 10 of whom shall be awarded studentships to the Uniformed Services
p.000017: Uni- versity of Health Sciences;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 272 PUBLIC HEALTH SERVICE ACT 68
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p.000017: (B) 100 dental students annually;
p.000017: (C) 250 nursing students annually;
p.000017: (D) 100 public health students annually;
p.000017: (E) 100 behavioral and mental health professional stu- dents annually;
p.000017: (F) 100 physician assistant or nurse practitioner stu- dents annually; and
p.000017: (G) 50 pharmacy students annually.
p.000017: (2) LOCATIONS.—The Track shall be located at existing and accredited, affiliated health professions education training
p.000017: pro- grams at academic health centers located in regions of the United States determined appropriate by the
p.000017: Surgeon General, in consultation with the National Health Care Workforce Com- mission established in section 5101
p.000017: of the Patient Protection and Affordable Care Act.
p.000017: (b) NUMBER OF GRADUATES.—Except as provided in subsection (a), the number of persons to be graduated from the Track
p.000017: shall be prescribed by the Secretary. In so prescribing the number of per- sons to be graduated from the
p.000017: Track, the Secretary shall institute actions necessary to ensure the maximum number of first-year en- rollments in
p.000017: the Track consistent with the academic capacity of the affiliated sites and the needs of the United States for medical,
p.000017: den- tal, and nursing personnel.
p.000017: (c) DEVELOPMENT.—The development of the Track may be by such phases as the Secretary may prescribe subject to
p.000017: the require- ments of subsection (a).
p.000017: (d) INTEGRATED LONGITUDINAL PLAN.—The Surgeon General shall develop an integrated longitudinal plan for health
p.000017: professions continuing education throughout the continuum of health-related education, training, and practice.
p.000017: Training under such plan shall emphasize patient-centered, interdisciplinary, and care coordina- tion
p.000017: skills. Experience with deployment of emergency response teams shall be included during the clinical experiences.
p.000017: (e) FACULTY DEVELOPMENT.—The Surgeon General shall de- velop faculty development programs and curricula in
p.000017: decentralized venues of health care, to balance urban, tertiary, and inpatient venues.
p.000017: SEC. 272. ø239l–1¿ ADMINISTRATION.
p.000017: (a) IN GENERAL.—The business of the Track shall be conducted by the Surgeon General with funds appropriated for
p.000017: and provided by the Department of Health and Human Services. The National Health Care Workforce Commission
p.000017: shall assist the Surgeon Gen- eral in an advisory capacity.
p.000017: (b) FACULTY.—
p.000017: (1) IN GENERAL.—The Surgeon General, after considering the recommendations of the National Health Care
p.000017: Workforce Commission, shall obtain the services of such professors, in- structors, and administrative and
p.000017: other employees as may be necessary to operate the Track, but utilize when possible, ex- isting
p.000017: affiliated health professions training institutions. Mem- bers of the faculty and staff shall be employed
p.000017: under salary schedules and granted retirement and other related benefits prescribed by the Secretary so as to
p.000017: place the employees of the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: mental health, pub- lic health, and nursing students for some significant period of time together, but at a minimum
p.000017: have a discrete and shared core cur- riculum.
p.000017: (e) ELITE FEDERAL DISASTER TEAMS.—The Surgeon General, in consultation with the Secretary, the Director of the Centers
p.000017: for Dis- ease Control and Prevention, and other appropriate military and Federal government agencies, shall
p.000017: develop criteria for the appoint- ment of highly qualified Track faculty, medical, dental, physician assistant,
p.000017: pharmacy, behavioral and mental health, public health, and nursing students, and graduates to elite
p.000017: Federal disaster pre- paredness teams to train and to respond to public health emer- gencies, natural
p.000017: disasters, bioterrorism events, and other emer- gencies.
p.000017: (f) STUDENT DROPPED FROM TRACK IN AFFILIATE SCHOOL.—A medical, dental, physician assistant, pharmacy,
p.000017: behavioral and mental health, public health, or nursing student who, under regu- lations prescribed by
p.000017: the Surgeon General, is dropped from the Track in an affiliated school for deficiency in conduct or studies, or
p.000017: for other reasons, shall be liable to the United States for all tuition and stipend support provided to the student.
p.000017: SEC. 274. ø239l–3¿ FUNDING.
p.000017: Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services
p.000017: Emergency Fund such sums as may be necessary to carry out this part.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 73 PUBLIC HEALTH SERVICE ACT Sec. 301
p.000017:
p.000017: TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
p.000017: PART A—RESEARCH AND INVESTIGATION
p.000017: IN GENERAL
p.000017: SEC. 301. ø241¿ (a) The Secretary shall conduct in the Service, and encourage, cooperate with, and render
p.000017: assistance to other ap- propriate public authorities, scientific institutions, and scientists in the conduct of,
p.000017: and promote the coordination of, research, inves- tigations, experiments, demonstrations, and studies relating to
p.000017: the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of
p.000017: man, including water pu- rification, sewage treatment, and pollution of lakes and streams. In carrying out the
p.000017: foregoing the Secretary is authorized to—
p.000017: (1) collect and make available through publications and other appropriate means, information as to, and
p.000017: the practical application of, such research and other activities;
p.000017: (2) make available research facilities of the Service to ap- propriate public authorities, and to health
p.000017: officials and sci- entists engaged in special study;
p.000017: (3) make grants-in-aid to universities, hospitals, labora- tories, and other public or private
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p.000017: contractors, the Secretary may direct such contractors to collect payments on behalf of the Secretary for
p.000017: the costs incurred to make available such substances and organisms and to forward amounts so collected to the
p.000017: Sec- retary, in the time and manner specified by the Secretary.
p.000017: (3) Amounts collected under paragraph (2) shall be credited to the appropriations accounts that incurred the
p.000017: costs to make avail- able the research substances and living organisms involved, and shall remain
p.000017: available until expended for carrying out activities under such accounts.
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p.000017: January 30, 2020
p.000017: NARCOTICS
p.000017: SEC. 302. ø242¿ (a) In carrying out the purposes of section 301 with respect to drugs the use or misuse of
p.000017: which might result in drug abuse or dependency, the studies and investigations author- ized therein shall
p.000017: include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further
p.000017: include the quantities of crude opium, coca leaves, and their salts, deriva- tives, and preparations, and
p.000017: other drugs subject to control under the Controlled Substances Act and Controlled Substances Import and
p.000017: Export Act, together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific
p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 304 PUBLIC HEALTH SERVICE ACT 78
p.000017:
p.000017: experience in the care, treatment, and rehabilitation of narcotic ad- dicts to the end that each State may be
p.000017: encouraged to provide ade- quate facilities and methods for the care and treatment of its nar- cotic addicts.
p.000017: GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND DEMONSTRATIONS IN HEALTH STATISTICS, HEALTH
p.000017: SERVICES, AND HEALTH CARE TECHNOLOGY ASSESSMENT
p.000017: SEC. 304. 1 ø242b¿ (a) The Secretary may, through the Agency for Health Care Policy and Research or the
p.000017: National Center for Health Statistics or using National Research Service Awards or other appropriate
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p.000017: and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the
p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
p.000017:
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p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 91 PUBLIC HEALTH SERVICE ACT Sec. 312
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p.000017: sponders, to administer immediate care, including cardiopulmonary resuscitation and
p.000017: automated external defibrillation, to cardiac arrest victims;
p.000017: (2) by purchasing automated external defibrillators, plac- ing the defibrillators in public places where cardiac
p.000017: arrests are likely to occur, and training personnel in such places to admin- ister cardiopulmonary resuscitation and
p.000017: automated external defibrillation to cardiac arrest victims;
p.000017: (3) by setting procedures for proper maintenance and test- ing of such devices, according to the guidelines of the
p.000017: manufac- turers of the devices;
p.000017: (4) by providing training to members of the public in cardiopulmonary resuscitation and automated
p.000017: external defibrillation;
p.000017: (5) by integrating the emergency medical services system with the public access defibrillation programs so
p.000017: that emer- gency medical services personnel, including dispatchers, are in- formed about the location of
p.000017: automated external defibrillators in their community; and
p.000017: (6) by encouraging private companies, including small businesses, to purchase automated external
p.000017: defibrillators and provide training for their employees to administer cardiopulmonary
p.000017: resuscitation and external automated defibrillation to cardiac arrest victims in their community.
p.000017: (b) PREFERENCE.—In awarding grants under subsection (a), the Secretary shall give a preference to a State, political
p.000017: subdivision of a State, Indian tribe, or tribal organization that—
p.000017: (1) has a particularly low local survival rate for cardiac ar- rests, or a particularly low local response rate
p.000017: for cardiac ar- rest victims; or
p.000017: (2) demonstrates in its application the greatest commit- ment to establishing and maintaining a
p.000017: public access defibrillation program.
p.000017: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, or tribal organization that receives
p.000017: a grant under sub- section (a) may use funds received through such grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide automated external defibrillation and basic life support training in automated external
p.000017: defibrillator usage through nationally recognized courses;
p.000017: (3) provide information to community members about the public access defibrillation program to be funded
p.000017: with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in public places;
p.000017: (5) produce materials to encourage private companies, in- cluding small businesses, to purchase
p.000017: automated external defibrillators;
p.000017: (6) establish an information clearinghouse, that shall be administered by an organization that has substantial
p.000017: expertise in pediatric education, pediatric medicine, and
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 313 PUBLIC HEALTH SERVICE ACT 92
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p.000017: electrophysiology and sudden death, that provides information to increase public access to defibrillation in
p.000017: schools; and
p.000017: (7) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (d) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a State, political subdivision
p.000017: of a State, Indian tribe, or tribal organization shall prepare and submit an appli- cation to the Secretary at such
p.000017: time, in such manner, and con- taining such information as the Secretary may reasonably re- quire.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) shall—
p.000017: (A) describe the comprehensive public access defibrillation program to be funded with the
p.000017: grant and demonstrate how such program would make automated ex- ternal defibrillation accessible and available to
p.000017: cardiac ar- rest victims in the community;
p.000017: (B) contain procedures for implementing appropriate nationally recognized training courses in
p.000017: performing cardiopulmonary resuscitation and the use of automated external defibrillators;
p.000017: (C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with
p.000017: the local emergency medical services system in the over- sight of training and notification of incidents of the
p.000017: use of the automated external defibrillators;
p.000017: (D) contain procedures for proper maintenance and testing of the automated external defibrillators,
p.000017: according to the labeling of the manufacturer;
p.000017: (E) contain procedures for ensuring notification of local emergency medical services system personnel, including
p.000017: dispatchers, of the location and type of devices used in the public access defibrillation program; and
p.000017: (F) provide for the collection of data regarding the ef- fectiveness of the public access defibrillation
p.000017: program to be funded with the grant in affecting the out-of-hospital car- diac arrest survival rate.
p.000017: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000017: to be appropriated
p.000017: $25,000,000 for for 6 each of fiscal years 2003 through 2014. Not more than 10 percent of amounts
p.000017: received under a grant awarded under this section may be used for administrative expenses.
p.000017: SEC. 313. ø245¿ PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal
p.000017: organizations to de- velop and implement innovative, comprehensive, community-based public access defibrillation
p.000017: demonstration projects that—
p.000017: (1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in
p.000017: unique set- tings;
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p.000017: January 30, 2020
p.000017: 6 The words ‘‘for for’’ so in law.
p.000017:
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 93 PUBLIC HEALTH SERVICE ACT Sec. 313
p.000017:
p.000017: (2) provide training to community members in cardiopulmonary resuscitation and
p.000017: automated external defibrillation; and
p.000017: (3) maximize community access to automated external defibrillators.
p.000017: (b) USE OF FUNDS.—A recipient of a grant under subsection (a) shall use the funds provided through the grant to—
p.000017: (1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and
p.000017: Drug Administration;
p.000017: (2) provide basic life training in automated external defibrillator usage through nationally recognized
p.000017: courses;
p.000017: (3) provide information to community members about the public access defibrillation demonstration project
p.000017: to be funded with the grant;
p.000017: (4) provide information to the local emergency medical services system regarding the placement of automated
p.000017: external defibrillators in the unique settings; and
p.000017: (5) further develop strategies to improve access to auto- mated external defibrillators in public places.
p.000017: (c) APPLICATION.—
p.000017: (1) IN GENERAL.—To be eligible to receive a grant under subsection (a), a political subdivision of a
p.000017: State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in
p.000017: such manner, and containing such information as the Secretary may reasonably require.
p.000017: (2) CONTENTS.—An application submitted under paragraph
p.000017: (1) may—
p.000017: (A) describe the innovative, comprehensive, commu- nity-based public access defibrillation
p.000017: demonstration project to be funded with the grant;
p.000017: (B) explain how such public access defibrillation dem- onstration project represents innovation in
p.000017: providing pub- lic access to automated external defibrillation; and
p.000017: (C) provide for the collection of data regarding the ef- fectiveness of the demonstration project to be funded
p.000017: with the grant in—
p.000017: (i) providing emergency cardiopulmonary resus- citation and automated external defibrillation to car- diac
p.000017: arrest victims in the setting served by the dem- onstration project; and
p.000017: (ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.
p.000017: (d) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000017: $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received
p.000017: under a grant awarded under this section may be used for administrative expenses.
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
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p.000017: of im- proved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out
p.000017: this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June
p.000017: 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30,
p.000017: 1969,
p.000017: $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000
p.000017: for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and
p.000017: $4,700,000 for the fiscal year ending June 30, 1974.
p.000017: SEC. 315. ø42 U.S.C. 247¿ ASSISTING VETERANS WITH MILITARY EMER- GENCY MEDICAL TRAINING TO MEET REQUIREMENTS
p.000017: FOR BECOMING CIVILIAN HEALTH CARE PROFES- SIONALS.
p.000017: (a) PROGRAM.—
p.000017: (1) IN GENERAL.—The Secretary may establish a program, in consultation with the Secretary of Labor,
p.000017: consisting of awarding demonstration grants to States to streamline State requirements and procedures in
p.000017: order to assist veterans who held certain military occupational specialties related to medical care or who have
p.000017: completed certain medical training while serving in the Armed Forces of the United States to meet cer- tification,
p.000017: licensure, and other requirements applicable to civil- ian health care professions (such as emergency medical techni-
p.000017: cian, paramedic, licensed practical nurse, registered nurse, physical therapy assistant, or physician
p.000017: assistant professions) in the State.
p.000017: (2) CONSULTATION AND COLLABORATION.—In determining the eligible military occupational specialties or training
p.000017: courses and the assistance required as described in paragraph (1), the Secretary shall consult with the Secretary of
p.000017: Defense, the Sec- retary of Veterans Affairs, and the Assistant Secretary of Labor for Veterans’
p.000017: Employment and Training, and shall col- laborate with the initiatives carried out under section 4114 of
p.000017: title 38, United States Code, and sections 1142 through 1144 of title 10, United States Code.
p.000017: (b) USE OF FUNDS.—Amounts received as a demonstration grant under this section shall be used to—
p.000017: (1) prepare and implement a plan to streamline State re- quirements and procedures as described in
p.000017: subsection (a), in- cluding by—
p.000017: (A) determining the extent to which the requirements for the education, training, and skill level of civilian
p.000017: health care professions (such as emergency medical technicians, paramedics, licensed practical nurses,
p.000017: registered nurses, physical therapy assistants, or physician assistants) in the State are equivalent to
p.000017: requirements for the education, training, and skill level of veterans who served in medical
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: 99 PUBLIC HEALTH SERVICE ACT Sec. 317
p.000017:
p.000017: related fields while a member of the Armed Forces of the United States; and
p.000017: (B) identifying methods, such as waivers, for veterans who served in medical related fields while a member of the Armed
p.000017: Forces of the United States to forgo or meet any such equivalent State requirements; and
p.000017: (2) if necessary to meet workforce shortages or address gaps in education, training, or skill level to
p.000017: meet certification, licensure or other requirements applicable to becoming a civil- ian health care professional
p.000017: (such as an emergency medical technician, paramedic, licensed practical nurse, registered nurse,
p.000017: physical therapy assistant, or physician assistant pro- fessions) in the State, develop or expand career pathways
p.000017: at in- stitutions of higher education to support veterans in meeting such requirements.
p.000017: (c) REPORT.—Upon the completion of the demonstration pro- gram under this section, the Secretary shall
p.000017: submit to Congress a report on the program.
p.000017: (d) FUNDING.—No additional funds are authorized to be appro- priated for the purpose of carrying out this
p.000017: section. This section shall be carried out using amounts otherwise available for such purpose.
p.000017: (e) SUNSET.—The demonstration program under this section shall not exceed 5 years.
p.000017: FAMILY SUPPORT GROUPS FOR ALZHEIMER’S DISEASE PATIENTS
p.000017: SEC. 316. 8 ø247a¿ (a) Subject to available appropriations, the Secretary, acting through the National Institute
p.000017: of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the
p.000017: establishment of family support groups to provide, without charge, educational, emotional, and practical sup- port to
p.000017: assist individuals with Alzheimer’s disease or a related memory disorder and members of the families of
p.000017: such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
p.000017: (1) university medical centers and other appropriate health care facilities which receive Federal funds from the
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p.000117: relevant research so that new tools can be uti- lized in public health practice.
p.000117: (3) Demonstration projects for—
p.000117: (A) the development of regional capabilities to prevent, control, and eliminate tuberculosis and prevent
p.000117: multidrug resistant and extensively drug resistant strains of tuber- culosis;
p.000117: (B) the intensification of efforts to reduce health dis- parities in the incidence of tuberculosis;
p.000117: (C) the intensification of efforts to control tuberculosis along the United States-Mexico border and among
p.000117: United States-Mexico binational populations, including through expansion of the scope and number of programs
p.000117: that—
p.000117: (i) detect and treat binational cases of tuber- culosis; and
p.000117: (ii) treat high-risk cases of tuberculosis referred from Mexican health departments;
p.000117: (D) the intensification of efforts to prevent, detect, and treat tuberculosis among foreign-born persons who are
p.000117: in the United States;
p.000117: (E) the intensification of efforts to prevent, detect, and treat tuberculosis among populations and settings
p.000117: docu- mented as having a high risk for tuberculosis; and
p.000117: (F) tuberculosis detection, control, and prevention.
p.000117: (4) Public information and education activities.
p.000117: (5) Education, training, clinical skills improvement activi- ties, and workplace exposure prevention
p.000117: for health profes- sionals, including allied health personnel and emergency re- sponse employees.
p.000117: (6) Support of Centers to carry out activities under para- graphs (1) through (4).
p.000117: (7) Collaboration with international organizations and for- eign countries in carrying out such activities.
p.000117: (8) Develop, enhance, and expand information technologies that support tuberculosis control including surveillance
p.000117: and database management systems with cross-jurisdictional capa- bilities, which shall conform to the standards
p.000117: and implementa- tion specifications for such information technologies as rec- ommended by the Secretary.
p.000117: (c) COOPERATION WITH PROVIDERS OF PRIMARY HEALTH SERV- ICES.—The Secretary may make a grant under subsection (a)
p.000117: or (b) only if the applicant for the grant agrees that, in carrying out ac- tivities under the grant,
p.000117: the applicant will cooperate with public and nonprofit private providers of primary health services or
p.000117: sub- stance abuse services, including entities receiving assistance under section 329, 330, or 340A or under title V or
p.000117: XIX.
p.000117: (d) APPLICATION FOR GRANT.—
p.000117: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) or (b) only if an application for the grant
p.000117: is sub-
p.000117: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000121: dis- ciplines relevant to the research under consideration;
p.000121: (B) members from public-private partnerships, private entities, or foundations (or both) engaged in activities
p.000121: rel- evant to research under consideration;
p.000121: (C) members of national and international nongovern- mental organizations established to address tuberculosis
p.000121: elimination;
p.000121: (D) members from the general public who are knowl- edgeable with respect to tuberculosis including individuals
p.000121: who have or have had tuberculosis; and
p.000121: (E) scientists, physicians, laboratorians, and other health professionals who reside in a foreign
p.000121: country with a substantial incidence or prevalence of tuberculosis, and who represent the specialties and
p.000121: disciplines relevant to the research under consideration.
p.000121: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000121:
p.000121: (1) GENERAL PROGRAM.—
p.000121: (A) IN GENERAL.—For the purpose of carrying out this section, there are authorized to be appropriated
p.000121: $200,000,000 for fiscal year 2009, $210,000,000 for fiscal year 2010, $220,500,000 for fiscal year 2011,
p.000121: $231,525,000 for fiscal year 2012, and $243,101,250 for fiscal year 2013.
p.000121: (B) RESERVATION FOR EMERGENCY GRANTS.—Of the amounts appropriated under subparagraph (A) for a fiscal year,
p.000121: the Secretary may reserve not more than 25 percent for emergency grants under subsection (a) for any geo-
p.000121: graphic area, State, political subdivision of a State, or other public entity in which there is,
p.000121: relative to other areas, a substantial number of cases of tuberculosis, multidrug resistant
p.000121: tuberculosis, or extensively drug re- sistant tuberculosis or a substantial rate of increase in such cases.
p.000121: (C) PRIORITY.—In allocating amounts appropriated under subparagraph (A), the Secretary shall give
p.000121: priority to allocating such amounts for grants under subsection (a).
p.000121: (D) ALLOCATION OF FUNDS.—
p.000121: (i) REQUIREMENT OF FORMULA.—Of the amounts appropriated under subparagraph (A), not reserved under
p.000121: subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall
p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
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p.000143: PUBLIC HEALTH SERVICE ACT
p.000143: Sec. 317S
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p.000143: political subdivisions of States, for the operation, including im- provement, of control programs.
p.000143: (2) PREFERENCE IN MAKING GRANTS.—In making grants under paragraph (1), the Secretary shall give
p.000143: preference to a political subdivision or consortium of political subdivisions that—
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p.000143: (A) has—
p.000143: (i) a history of elevated incidence or prevalence of mosquito-borne disease;
p.000143: (ii) a population of infected mosquitoes;
p.000143: (iii) met criteria determined by the Secretary to suggest an increased risk of elevated incidence
p.000143: or prevalence of mosquito-borne disease in the pending fiscal year, including an emerging infectious mosquito-
p.000143: borne disease that presents a serious public health threat; or
p.000143: (iv) a public health emergency due to the inci- dence or prevalence of a mosquito-borne disease that
p.000143: presents a serious public health threat;
p.000143: (B) demonstrates to the Secretary that such political subdivision or consortium of political subdivisions
p.000143: will, if appropriate to the mosquito circumstances involved, effec- tively coordinate the activities of the
p.000143: control programs with contiguous political subdivisions;
p.000143: (C) demonstrates to the Secretary (directly or through State officials) that the State in which such a political sub-
p.000143: division or consortium of political subdivisions is located has identified or will identify geographic
p.000143: areas in such State that have a significant need for control programs and will effectively coordinate
p.000143: such programs in such areas; and
p.000143: (D)(i) is located in a State that has received a grant under subsection (a); or
p.000143: (ii) that demonstrates to the Secretary that the control program is consistent with existing State mosquito control
p.000143: plans or policies, or other applicable State preparedness plans.
p.000143: (3) REQUIREMENT OF ASSESSMENT AND PLAN.—A grant may be made under paragraph (1) only if the political
p.000143: subdivision or consortium of political subdivisions involved—
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p.000145: ties, parishes, and boroughs. If State law recognizes an entity of general government that functions in
p.000145: lieu of, and is not within, a county, parish, or borough, the Secretary may recognize an area under the
p.000145: jurisdiction of such other entities of general government as a political subdivision for purposes of this section.
p.000145: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000145: (1) IN GENERAL.—For the purpose of carrying out this sec- tion, there are authorized to be appropriated
p.000145: $100,000,000 for each of fiscal years 2019 through 2023.
p.000145: (2) PUBLIC HEALTH EMERGENCIES.—In the case of control programs carried out in response to a
p.000145: mosquito-borne disease that constitutes a public health emergency, the authorization of appropriations under
p.000145: paragraph (1) is in addition to applica- ble authorizations of appropriations under this Act and other medical
p.000145: and public health preparedness and response laws.
p.000145: (3) FISCAL YEAR 2019 APPROPRIATIONS.—For fiscal year 2019, 50 percent or more of the funds appropriated
p.000145: under para- graph (1) shall be used to award grants to political subdivi- sions or consortia of political
p.000145: subdivisions under subsection (b).
p.000145: SEC. 317T. ø247b–22¿ MICROBICIDE RESEARCH.
p.000145: (a) IN GENERAL.—The Director of the Centers for Disease Con- trol and Prevention is strongly encouraged to fully
p.000145: implement the Centers’ microbicide agenda to support research and development of microbicides for use to
p.000145: prevent the transmission of the human immunodeficiency virus.
p.000145: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated such sums as may be necessary for each
p.000145: of fiscal years 2009 through 2013 to carry out this section.
p.000145: SEC. 317U. ø???¿ NATIONAL STRATEGY AND REGIONAL CENTERS OF EXCELLENCE IN VECTOR-BORNE DISEASES.
p.000145: (a) IN GENERAL.—The Secretary shall—
p.000145: (1)(A) ensure the development and implementation of a na- tional strategy to address vector-borne diseases, including
p.000145: tick- borne diseases, that—
p.000145: (i) identifies and assesses gaps and any unnecessary duplication in federally-funded programs; and
p.000145: (ii) identifies strategic goals to address such diseases and appropriate benchmarks to measure progress
p.000145: toward achieving such goals; and
p.000145: (B) update such strategy, as appropriate; and
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p.000153: Sec. 319
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p.000153: priated such sums as may be necessary for each of the fiscal years 1993 through 1998.
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p.000153: January 30, 2020
p.000153: DATA COLLECTION REGARDING PROGRAMS UNDER TITLE XXVI
p.000153: SEC. 318B. ø247c–2¿ For the purpose of collecting and pro- viding data for program planning and
p.000153: evaluation activities under title XXVI, there are authorized to be appropriated to the Secretary (acting through the
p.000153: Director of the Centers for Disease Control and Prevention) such sums as may be necessary for each of the
p.000153: fiscal years 2001 through 2005. Such authorization of appropriations is in addition to other authorizations of
p.000153: appropriations that are avail- able for such purpose.
p.000153: SEC. 319. ø247d¿ PUBLIC HEALTH EMERGENCIES.
p.000153: (a) EMERGENCIES.—If the Secretary determines, after consulta- tion with such public health officials as may be
p.000153: necessary, that—
p.000153: (1) a disease or disorder presents a public health emer- gency; or
p.000153: (2) a public health emergency, including significant out- breaks of infectious diseases or bioterrorist
p.000153: attacks, otherwise exists,
p.000153: the Secretary may take such action as may be appropriate to re- spond to the public health emergency,
p.000153: including making grants, providing awards for expenses, and entering into contracts and con- ducting and supporting
p.000153: investigations into the cause, treatment, or prevention of a disease or disorder as described in paragraphs
p.000153: (1) and (2). Any such determination of a public health emergency ter- minates upon the Secretary declaring that the
p.000153: emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the
p.000153: determination is made by the Secretary, which- ever occurs first. Determinations that terminate under the pre-
p.000153: ceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and
p.000153: the preceding sentence applies to each such renewal. Not later than 48 hours after making a de-
p.000153: termination under this subsection of a public health emergency (in- cluding a renewal), the Secretary shall
p.000153: submit to the Congress written notification of the determination.
p.000153: (b) PUBLIC HEALTH EMERGENCY FUND.—
p.000153: (1) IN GENERAL.—There is established in the Treasury a fund to be designated as the ‘‘Public Health Emergency
p.000153: Fund’’ to be made available to the Secretary without fiscal year limi- tation to carry out subsection (a) only if a
p.000153: public health emer- gency has been declared by the Secretary under such sub- section or if the Secretary
p.000153: d-etermines there is the significant potential for a public health emergency, to allow the Secretary to rapidly
p.000153: respond to the immediate needs resulting from such public health emergency or potential public health emergency. The
p.000153: Secretary shall plan for the expedited distribution of funds to appropriate agencies and entities. There is authorized
p.000153: to be appropriated to the Fund such sums as may be necessary.
p.000153: (2) USES.—The Secretary may use amounts in the Fund established under paragraph (1), to—
p.000153: (A) facilitate coordination between and among Federal, State, local, Tribal, and territorial entities and public
p.000153: and
p.000153: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000153: Sec. 319 PUBLIC HEALTH SERVICE ACT 154
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p.000153: January 30, 2020
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p.000153: private health care entities that the Secretary determines may be affected by a public health emergency or
p.000153: potential public health emergency referred to in paragraph (1) (in- cluding communication of such entities with
p.000153: relevant inter- national entities, as applicable);
p.000153: (B) make grants, provide for awards, enter into con- tracts, and conduct supportive investigations pertaining
p.000153: to a public health emergency or potential public health emer- gency, including further supporting programs under
p.000153: sec- tion 319C–1, 319C–2, or 319C–3;
p.000153: (C) facilitate and accelerate, as applicable, advanced research and development of security countermeasures (as
p.000153: defined in section 319F–2), qualified countermeasures (as defined in section 319F–1), or qualified pandemic
p.000153: or epi- demic products (as defined in section 319F–3), that are ap- plicable to the public health emergency or
p.000153: potential public health emergency under paragraph (1);
p.000153: (D) strengthen biosurveillance capabilities and labora- tory capacity to identify, collect, and analyze
p.000153: information regarding such public health emergency or potential public health emergency, including the systems
p.000153: under section 319D;
p.000153: (E) support initial emergency operations and assets re- lated to preparation and deployment of intermittent dis-
p.000153: aster response personnel under section 2812 and the Med- ical Reserve Corps under section 2813; and
p.000153: (F) carry out other activities, as the Secretary deter- mines applicable and appropriate.
p.000153: (3) REPORT.—Not later than 90 days after the end of each fiscal year, the Secretary shall prepare and submit to the
p.000153: Com- mittee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the
p.000153: Committee on Commerce and the Committee on Appropriations of the House of Representatives a report describing—
p.000153: (A) the expenditures made from the Public Health Emergency Fund in such fiscal year; and
p.000153: (B) each public health emergency for which the ex- penditures were made and the activities undertaken
p.000153: with respect to each emergency which was conducted or sup- ported by expenditures from the Fund.
p.000153: (4) REVIEW.—Not later than 2 years after the date of en- actment of the Pandemic and All-Hazards
p.000153: Preparedness and Advancing Innovation Act of 2019, the Secretary, in coordina- tion with the Assistant
p.000153: Secretary for Preparedness and Re- sponse, shall conduct a review of the Fund under this section and
p.000153: provide recommendations to the Committee on Health, Education, Labor, and Pensions and the Committee on Appro-
p.000153: priations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the
p.000153: House of Representatives on policies to improve such Fund for the uses described in paragraph (2).
p.000153: (5) GAO REPORT.—Not later than 4 years after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.000153: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000155: PUBLIC HEALTH SERVICE ACT
p.000155: Sec. 319
p.000155:
p.000155: Advancing Innovation Act of 2019, the Comptroller General of the United States shall—
p.000155: (A) conduct a review of the Fund under this section, including its uses and the resources available in the
p.000155: Fund; and
p.000155: (B) submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee
p.000155: on Energy and Commerce of the House of Representatives a report on such review, including recommendations
p.000155: related to such review, as applicable.
p.000155: (c) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under this section shall be used to rapidly respond to public
p.000155: health emer- gencies or potential public health emergencies and supplement and not supplant other Federal, State,
p.000155: and local public funds provided for activities under this Act or funds otherwise provided for emer- gency
p.000155: response.
p.000155: (d) DATA SUBMITTAL AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or partially
p.000155: as a re- sult of a public health emergency that has been determined pursu- ant to subsection (a), individuals or
p.000155: public or private entities are unable to comply with deadlines for the submission to the Sec- retary of
p.000155: data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any
p.000155: other provi- sion of law, grant such extensions of such deadlines as the cir- cumstances reasonably require,
p.000155: and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly
p.000155: after granting such an extension or waiver, the Sec- retary shall notify the Congress of such action
p.000155: and publish in the Federal Register a notice of the extension or waiver.
p.000155: (e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PER-
p.000155: SONNEL DURING A PUBLIC HEALTH EMERGENCY.—
p.000155: (1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PER- SONNEL.—Notwithstanding any other provision of law,
p.000155: and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such
p.000155: Governor or tribal orga- nization’s designee, the Secretary may authorize the requesting State or Indian tribe to
p.000155: temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian
p.000155: tribe, State and local public health department or agency personnel funded in whole or in part through programs
p.000155: authorized under this Act, as appropriate.
p.000155: (2) ACTIVATION OF EMERGENCY REASSIGNMENT.—
p.000155: (A) PUBLIC HEALTH EMERGENCY.—The Secretary may authorize a temporary reassignment of personnel under
p.000155: paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).
p.000155: (B) CONTENTS OF REQUEST.—To seek authority for a temporary reassignment of personnel under paragraph (1), the
p.000155: Governor of a State or a tribal organization shall sub- mit to the Secretary a request for such reassignment flexi-
p.000155: bility and shall include in the request each of the fol- lowing:
p.000155:
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p.000155: January 30, 2020
p.000155: (i) An assurance that the public health emergency in the geographic area of the requesting State or In-
p.000155: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000155: dian tribe cannot be adequately and appropriately ad- dressed by the public health workforce otherwise
p.000155: available.
p.000155: (ii) An assurance that the public health emergency would be addressed more efficiently and effectively through
p.000155: the requested temporary reassignment of State and local personnel described in paragraph (1).
p.000155: (iii) An assurance that the requested temporary reassignment of personnel is consistent with any ap-
p.000155: plicable All-Hazards Public Health Emergency Pre- paredness and Response Plan under section 319C–1.
p.000155: (iv) An identification of—
p.000155: (I) each Federal program from which per- sonnel would be temporarily reassigned pursuant to the
p.000155: requested authority; and
p.000155: (II) the number of personnel who would be so reassigned from each such program.
p.000155: (v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization
p.000155: agree.
p.000155: (C) CONSIDERATION.—In reviewing a request for tem- porary reassignment under paragraph (1), the Secretary
p.000155: shall consider the degree to which the program or pro- grams funded in whole or in part by programs
p.000155: authorized under this Act would be adversely affected by the reassign- ment.
p.000155: (D) TERMINATION AND EXTENSION.—
p.000155: (i) TERMINATION.—A State or Indian tribe’s tem- porary reassignment of personnel under paragraph (1) shall
p.000155: terminate upon the earlier of the following:
p.000155: (I) The Secretary’s determination that the public health emergency no longer exists.
p.000155: (II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Sec- retary approved
p.000155: the State or Indian tribe’s request for such reassignment flexibility.
p.000155: (ii) EXTENSION OF REASSIGNMENT FLEXIBILITY.— The Secretary may extend reassignment flexibility of
p.000155: personnel under paragraph (1) beyond the date other- wise applicable under clause (i)(II) if the public health
p.000155: emergency still exists as of such date, but only if—
p.000155: (I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel
p.000155: submits a request for an extension of such temporary reassignment; and
p.000155: (II) the request for an extension contains the same information and assurances necessary for the approval
p.000155: of an initial request for such tem- porary reassignment pursuant to subparagraph (B).
p.000155: (3) VOLUNTARY NATURE OF TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL.—
p.000155: (A) IN GENERAL.—Unless otherwise provided under the law or regulation of the State or Indian tribe that receives
p.000155: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000157: PUBLIC HEALTH SERVICE ACT
p.000157: Sec. 319
p.000157:
p.000157: authorization for temporary reassignment of personnel under paragraph (1), personnel eligible for
p.000157: reassignment pursuant to such authorization—
p.000157: (i) shall have the opportunity to volunteer for tem- porary reassignment; and
p.000157: (ii) shall not be required to agree to a temporary reassignment.
p.000157: (B) PROHIBITION ON CONDITIONING FEDERAL AWARDS.— The Secretary may not condition the award of a grant, con- tract,
p.000157: or cooperative agreement under this Act on the re- quirement that a State or Indian tribe require that
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p.000157: (7) DEFINITIONS.—In this subsection—
p.000157: (A) the terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given such terms in section 4 of
p.000157: the In-
p.000157: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000157: Sec. 319 PUBLIC HEALTH SERVICE ACT 158
p.000157: dian Self-Determination and Education Assistance Act; and
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p.000157: (B) the term ‘‘State’’ includes, in addition to the enti- ties listed in the definition of such term
p.000157: in section 2, the Freely Associated States.
p.000157: (8) SUNSET.—This subsection shall terminate on Sep- tember 30, 2023.
p.000157: (f) DETERMINATION WITH RESPECT TO PAPERWORK REDUCTION ACT WAIVER DURING A PUBLIC HEALTH EMERGENCY.—
p.000157: (1) DETERMINATION.—If the Secretary determines, after consultation with such public health officials as may
p.000157: be nec- essary, that—
p.000157: (A)(i) the criteria set forth for a public health emer- gency under paragraph (1) or (2) of subsection (a) has
p.000157: been met; or
p.000157: (ii) a disease or disorder, including a novel and emerg- ing public health threat, is significantly likely to become a
p.000157: public health emergency; and
p.000157: (B) the circumstances of such public health emergency, or potential for such significantly likely public
p.000157: health emergency, including the specific preparation for and re- sponse to such public health emergency or
p.000157: threat, neces- sitate a waiver from the requirements of subchapter I of chapter 35 of title 44, United
p.000157: States Code (commonly re- ferred to as the Paperwork Reduction Act),
p.000157: then the requirements of such subchapter I with respect to vol- untary collection of information shall not be
p.000157: applicable during the immediate investigation of, and response to, such public health emergency during
p.000157: the period of such public health emergency or the period of time necessary to determine if a
p.000157: disease or disorder, including a novel and emerging public health threat, will become a public health
p.000157: emergency as pro- vided for in this paragraph. The requirements of such sub- chapter I with respect to
p.000157: voluntary collection of information shall not be applicable during the immediate postresponse re- view
p.000157: regarding such public health emergency if such imme- diate postresponse review does not exceed a reasonable
p.000157: length of time.
p.000157: (2) TRANSPARENCY.—If the Secretary determines that a waiver is necessary under paragraph (1), the
p.000157: Secretary shall promptly post on the Internet website of the Department of Health and Human Services a brief
p.000157: justification for such waiv- er, the anticipated period of time such waiver will be in effect, and the agencies and
p.000157: offices within the Department of Health and Human Services to which such waiver shall apply, and up- date such
p.000157: information posted on the Internet website of the Department of Health and Human Services, as applicable.
p.000157: (3) EFFECTIVENESS OF WAIVER.—Any waiver under this subsection shall take effect on the date on which the
p.000157: Secretary posts information on the Internet website as provided for in this subsection.
p.000157: (4) TERMINATION OF WAIVER.—Upon determining that the circumstances necessitating a waiver under paragraph
p.000157: (1) no longer exist, the Secretary shall promptly update the Internet
p.000157: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000159: PUBLIC HEALTH SERVICE ACT
p.000159: Sec. 319A
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p.000159: January 30, 2020
p.000159: website of the Department of Health and Human Services to reflect the termination of such waiver.
p.000159: (5) LIMITATIONS.—
p.000159: (A) PERIOD OF WAIVER.—The period of a waiver under paragraph (1) shall not exceed the period of time for the
p.000159: related public health emergency, including a public health emergency declared pursuant to subsection (a), and
p.000159: any immediate postresponse review regarding the public health emergency consistent with the requirements of this
p.000159: sub- section.
p.000159: (B) SUBSEQUENT COMPLIANCE.—An initiative subject to a waiver under paragraph (1) that is ongoing after
p.000159: the date on which the waiver expires, shall be subject to the requirements of subchapter I of chapter
p.000159: 35 of title 44, United States Code, and the Secretary shall ensure that compliance with such requirements
p.000159: occurs in as timely a manner as possible based on the applicable circumstances, but not to exceed 30 calendar
p.000159: days after the expiration of the applicable waiver.
p.000159: SEC. 319A. ø247d–1¿ VACCINE TRACKING AND DISTRIBUTION.
p.000159: (a) TRACKING.—The Secretary, together with relevant manufac- turers, wholesalers, and distributors as may agree
p.000159: to cooperate, may track the initial distribution of federally purchased influenza vaccine in an influenza
p.000159: pandemic. Such tracking information shall be used to inform Federal, State, local, and tribal decision makers during an
p.000159: influenza pandemic.
p.000159: (b) DISTRIBUTION.—The Secretary shall promote communica- tion between State, local, and tribal public health
p.000159: officials and such manufacturers, wholesalers, and distributors as agree to partici- pate, regarding the
p.000159: effective distribution of seasonal influenza vac- cine. Such communication shall include estimates of high
p.000159: priority populations, as determined by the Secretary, in State, local, and tribal jurisdictions in order to
p.000159: inform Federal, State, local, and trib- al decision makers during vaccine shortages and supply disrup- tions.
p.000159: (c) CONFIDENTIALITY.—The information submitted to the Sec- retary or its contractors, if any, under this
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p.000159: distributors, wholesalers and State, local, and tribal health departments, shall develop guidelines for subsections (a)
p.000159: and (b).
p.000159: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000159: $30,800,000 for each of fiscal years 2019 through 2023.
p.000159: (f) REPORT TO CONGRESS.—As part of the National Health Se- curity Strategy described in section 2802,
p.000159: the Secretary shall pro- vide an update on the implementation of subsections (a) through (d).
p.000159: SEC. 319C–1. ø247d–3a¿ IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY. 17
p.000159: (a) IN GENERAL.—To enhance the security of the United States with respect to public health emergencies, the
p.000159: Secretary, acting through the Director of the Centers for Disease Control and Pre- vention, shall award
p.000159: cooperative agreements to eligible entities to enable such entities to conduct the activities described in
p.000159: sub- section (d).
p.000159: (b) ELIGIBLE ENTITIES.—To be eligible to receive an award under subsection (a), an entity shall—
p.000159: (1)(A) be a State;
p.000159: (B) be a political subdivision determined by the Secretary to be eligible for an award under this section
p.000159: (based on criteria described in subsection (h)(4)); or
p.000159: (C) be a consortium of States; and
p.000159: (2) prepare and submit to the Secretary an application at such time, and in such manner, and containing
p.000159: such informa- tion as the Secretary may require, including—
p.000159: (A) an All-Hazards Public Health Emergency Pre- paredness and Response Plan which shall include—
p.000159: (i) a description of the activities such entity will carry out under the agreement to meet the goals iden-
p.000159: tified under section 2802, including with respect to chemical, biological, radiological, or nuclear
p.000159: threats, whether naturally occurring, unintentional, or delib- erate;
p.000159: (ii) a description of the activities such entity will carry out with respect to pandemic influenza, as
p.000159: a component of the activities carried out under clause (i), and consistent with the requirements of
p.000159: para- graphs (2) and (5) of subsection (g);
p.000159: (iii) preparedness and response strategies and ca- pabilities that take into account the medical and pub-
p.000159:
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p.000159: January 30, 2020
p.000159: 17 Former sections 319B and 319C were repealed by section 204(b)(1) of Public Law 109–417 (120 Stat.
p.000159: 2951).
p.000159: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000161: PUBLIC HEALTH SERVICE ACT
p.000161: Sec. 319C–1
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p.000161: lic health needs of at-risk individuals in the event of a public health emergency;
p.000161: (iv) 18 a description of the mechanism the entity will implement to utilize the Emergency Management
p.000161: Assist- ance Compact, or other mutual aid agreement, for medical and public health mutual aid, and, as appropriate, the
p.000161: ac- tivities such entity will implement pursuant to section 319I to improve enrollment and coordination of
p.000161: volunteer health care professionals seeking to provide medical serv- ices during a public health
p.000161: emergency, which may in- clude—
p.000161: (I) providing a public method of communication for purposes of volunteer coordination (such as a
p.000161: phone number);
p.000161: (II) providing for optional registration to partici- pate in volunteer services during processes related
p.000161: to State medical licensing, registration, or certification or renewal of such licensing, registration, or
p.000161: certification; or
p.000161: (III) other mechanisms as the State determines appropriate;
p.000161: (v) a description of how the entity will include the State Unit on Aging in public health emergency pre-
p.000161: paredness;
p.000161: (vi) a description of how, as appropriate, the enti- ty may partner with relevant public and private stake- holders,
p.000161: including public health agencies with specific expertise that may be relevant to public health secu- rity,
p.000161: such as environmental health agencies, in public health emergency preparedness and response;
p.000161: (vii) a description of how, as applicable, such enti- ty may integrate information to account for individ- uals
p.000161: with behavioral health needs following a public health emergency;
p.000161: (viii) a description of how the entity, as applicable and appropriate, will coordinate with State emergency
p.000161: preparedness and response plans in public health emergency preparedness, including State educational
p.000161: agencies (as defined in section 8101 of the Elementary and Secondary Education Act of 1965) and State child care lead
p.000161: agencies (designated under section 658D of the Child Care and Development Block Grant Act of 1990);
p.000161: (ix) in the case of entities that operate on the United States-Mexico border or the United States-
p.000161: Canada border, a description of the activities such en- tity will carry out under the agreement that are spe-
p.000161: cific to the border area including disease detection, identification, investigation, and preparedness and re-
p.000161: sponse activities related to emerging diseases and in- fectious disease outbreaks whether naturally occurring
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p.000161: January 30, 2020
p.000161: 18 Margin for clause (iv) is so in law.
p.000161:
p.000161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000161: or due to bioterrorism, consistent with the require- ments of this section;
p.000161: (x) a description of any activities that such entity will use to analyze real-time clinical specimens
p.000161: for pathogens of public health or bioterrorism significance, including any utilization of poison control centers;
p.000161: (xi) a description of how the entity will partner with health care facilities, including hospitals
p.000161: and nursing homes and other long-term care facilities, to promote and improve public health preparedness
p.000161: and response; and
p.000161: (xii) a description of how, as appropriate and prac- ticable, the entity will include critical infrastructure
p.000161: partners, such as utility companies within the entity’s jurisdiction, in planning pursuant to this subpara- graph
p.000161: to help ensure that critical infrastructure will remain functioning during, or return to function as soon
p.000161: as practicable after, a public health emergency;
p.000161: (B) an assurance that the entity will report to the Sec- retary on an annual basis (or more frequently as
p.000161: deter- mined by the Secretary) on the evidence-based bench- marks and objective standards established
p.000161: by the Sec- retary to evaluate the preparedness and response capabili- ties of such entity under subsection (g);
p.000161: (C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that
p.000161: meets any criteria established by the Secretary to test the prepared- ness and response capabilities of such
p.000161: entity, including ad- dressing the needs of at-risk individuals, and that the enti- ty will report back to the
p.000161: Secretary within the application of the following year on the strengths and weaknesses identified through such
p.000161: exercise or drill, and corrective ac- tions taken to address material weaknesses;
p.000161: (D) an assurance that the entity will provide to the Secretary the data described under section
p.000161: 319D(c)(3) as determined feasible by the Secretary;
p.000161: (E) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of
p.000161: such entity on the role of such hospitals in the plan re- quired under subparagraph (A);
p.000161: (F) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and
p.000161: will implement an accountability system to ensure that such entity makes satisfactory annual improvement
p.000161: and describes such system in the plan under subparagraph (A);
p.000161: (G) a description of the means by which to obtain pub- lic comment and input on the plan described in subpara-
p.000161: graph (A) and on the implementation of such plan, that shall include an advisory committee or other similar
p.000161: mech- anism for obtaining comment from the public and from other State, local, and tribal stakeholders; and
p.000161: (H) as relevant, a description of the process used by the entity to consult with local departments
p.000161: of public health to reach consensus, approval, or concurrence on the
p.000161: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000163: PUBLIC HEALTH SERVICE ACT
p.000163: Sec. 319C–1
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p.000163: relative distribution of amounts received under this sec- tion.
p.000163: (c) LIMITATION.—Beginning in fiscal year 2009, the Secretary may not award a cooperative agreement to a
p.000163: State unless such State is a participant in the Emergency System for Advance Reg- istration of Volunteer
p.000163: Health Professionals described in section 319I.
p.000163: (d) USE OF FUNDS.—
p.000163: (1) IN GENERAL.—An award under subsection (a) shall be expended for activities to achieve the
p.000163: preparedness goals de- scribed under paragraphs (1), (2), (4), (5), and (6) of section 2802(b).
p.000163: (2) EFFECT OF SECTION.—Nothing in this subsection may be construed as establishing new regulatory
p.000163: authority or as modifying any existing regulatory authority.
p.000163: (e) COORDINATION WITH LOCAL RESPONSE CAPABILITIES.—An entity shall, to the extent practicable, ensure that
p.000163: activities carried out under an award under subsection (a) are coordinated with ac- tivities of relevant
p.000163: Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative,
p.000163: local emergency plans, and any regional health care emergency pre- paredness and response system
p.000163: established pursuant to the appli- cable guidelines under section 319C–3.
p.000163: (f) CONSULTATION WITH HOMELAND SECURITY.—In making awards under subsection (a), the Secretary shall
p.000163: consult with the Secretary of Homeland Security to—
p.000163: (1) ensure maximum coordination of public health and medical preparedness and response activities with the
p.000163: Metro- politan Medical Response System, and other relevant activities;
p.000163: (2) minimize duplicative funding of programs and activi- ties; and
p.000163: (3) analyze activities, including exercises and drills, con- ducted under this section to develop
p.000163: recommendations and guidance on best practices for such activities.
p.000163: (g) ACHIEVEMENT OF MEASURABLE EVIDENCE-BASED BENCH-
p.000163: MARKS AND OBJECTIVE STANDARDS.—
p.000163: (1) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness Act,
p.000163: the Secretary shall develop or where appropriate adopt, and re- quire the application of, measurable
p.000163: evidence-based bench- marks and objective standards that measure levels of pre- paredness with respect to
p.000163: the activities described in this sec- tion and with respect to activities described in section 319C–
p.000163: 2. In developing such benchmarks and standards, the Sec- retary shall consult with and seek comments from
p.000163: State, local, and tribal officials and private entities, as appropriate. Where appropriate, the Secretary shall
p.000163: incorporate existing objective standards. Such benchmarks and standards shall—
p.000163: (A) include outcome goals representing operational achievements of the National Preparedness Goals
p.000163: devel- oped under section 2802(b) with respect to all-hazards, in- cluding chemical, biological, radiological,
p.000163: or nuclear threats; and
p.000163: (B) at a minimum, require entities to—
p.000163: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000163: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 164
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p.000163: (i) measure progress toward achieving the out- come goals; and
p.000163: (ii) at least annually, test, exercise, and rigorously evaluate the public health and medical emergency pre- paredness
p.000163: and response capabilities of the entity, and report to the Secretary on such measured and tested
p.000163: capabilities and measured and tested progress toward achieving outcome goals, based on criteria established by
p.000163: the Secretary.
p.000163: (2) CRITERIA FOR PANDEMIC INFLUENZA PLANS.—
p.000163: (A) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards
p.000163: Pre- paredness Act, the Secretary shall develop and dissemi- nate to the chief executive officer of each State
p.000163: criteria for an effective State plan for responding to pandemic influ- enza. The Secretary shall periodically
p.000163: update, as necessary and appropriate, such pandemic influenza plan criteria and shall require the integration
p.000163: of such criteria into the benchmarks and standards described in paragraph (1).
p.000163: (B) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to require the duplication of Federal ef-
p.000163: forts with respect to the development of criteria or stand- ards, without regard to whether such efforts
p.000163: were carried out prior to or after the date of enactment of this section.
p.000163: (3) TECHNICAL ASSISTANCE.—The Secretary shall, as deter- mined appropriate by the Secretary, provide to a
p.000163: State, upon request, technical assistance in meeting the requirements of this section, including the provision
p.000163: of advice by experts in the development of high-quality assessments, the setting of State objectives and
p.000163: assessment methods, the development of meas- ures of satisfactory annual improvement that are valid and re-
p.000163: liable, and other relevant areas.
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p.000169: and enhance community and hospital preparedness for, and response to, public health emer- gencies in
p.000169: accordance with subsection (c), including, as appropriate, capacity and preparedness to address the needs of
p.000169: children and other at-risk individuals.
p.000169: (b) ELIGIBILITY.—To be eligible for an award under subsection (a), an entity shall—
p.000169: (1)(A) be a coalition that includes—
p.000169: (i) one or more hospitals, at least one of which shall be a designated trauma center, consistent with
p.000169: section 1213(c);
p.000169: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000171: PUBLIC HEALTH SERVICE ACT
p.000171: Sec. 319C–2
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p.000171: (ii) one or more other local health care facilities, in- cluding clinics, health centers, community
p.000171: health centers, primary care facilities, mental health centers, mobile med- ical assets, or nursing homes;
p.000171: (iii)(I) one or more political subdivisions;
p.000171: (II) one or more States; or
p.000171: (III) one or more States and one or more political sub- divisions; and
p.000171: (iv) one or more emergency medical service organiza- tions or emergency management organizations; and
p.000171: (B) prepare, in consultation with the Chief Executive Offi- cer and the lead health officials of the State, District,
p.000171: or terri- tory in which the hospital and health care facilities described in subparagraph (A) are located,
p.000171: and submit to the Secretary, an application at such time, in such manner, and containing such information
p.000171: as the Secretary may require; or
p.000171: (2)(A) be an entity described in section 319C–1(b)(1); and
p.000171: (B) submit an application at such time, in such manner, and containing such information as the Secretary may
p.000171: require, including the information or assurances required under section 319C–1(b)(2) and an assurance that the
p.000171: State will adhere to any applicable guidelines established by the Secretary.
p.000171: (c) USE OF FUNDS.—An award under subsection (a) shall be ex- pended for activities to achieve the preparedness
p.000171: goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with respect to
p.000171: all-hazards, including chemical, biological, radiological, or nuclear threats.
p.000171: (d) PREFERENCES.—
p.000171: (1) REGIONAL COORDINATION.—In making awards under subsection (a), the Secretary shall give preference to
p.000171: eligible entities that submit applications that, in the determination of the Secretary—
p.000171: (A) will enhance coordination—
p.000171: (i) among the entities described in subsection (b)(1)(A)(i);
p.000171: (ii) among one or more facilities in a regional health care emergency system under section 319C–3; and
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p.000171: (iii) between such entities and the entities de- scribed in subsection (b)(1)(A)(ii); and
p.000171: (B) include, in the coalition described in subsection (b)(1)(A), a significant percentage of the
p.000171: hospitals and health care facilities within the geographic area served by such coalition.
p.000171: (2) OTHER PREFERENCES.—In making awards under sub- section (a), the Secretary shall give preference to eligible
p.000171: enti- ties that, in the determination of the Secretary—
p.000171: (A) include one or more hospitals that are participants in the National Disaster Medical System;
p.000171: (B) are located in a geographic area that faces a high degree of risk, as determined by the Secretary in
p.000171: consulta- tion with the Secretary of Homeland Security; or
p.000171: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000171: Sec. 319C–2 PUBLIC HEALTH SERVICE ACT 172
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p.000171: (C) have a significant need for funds to achieve the preparedness and response goals described in
p.000171: section 2802(b)(3).
p.000171: (e) CONSISTENCY OF PLANNED ACTIVITIES.—The Secretary may not award a cooperative agreement to an eligible
p.000171: entity described in subsection (b)(1) unless the application submitted by the entity is coordinated and
p.000171: consistent with an applicable State All-Hazards Public Health Emergency Preparedness and Response Plan and rel- evant
p.000171: local plans, as determined by the Secretary in consultation with relevant State health officials.
p.000171: (f) LIMITATION ON AWARDS.—A political subdivision shall not participate in more than one coalition
p.000171: described in subsection (b)(1).
p.000171: (g) COORDINATION.—
p.000171: (1) LOCAL RESPONSE CAPABILITIES.—An eligible entity shall, to the extent practicable, ensure that
p.000171: activities carried out under an award under subsection (a) are coordinated with activities of relevant local
p.000171: Metropolitan Medical Response Sys- tems, local Medical Reserve Corps, the local Cities Readiness Initiative,
p.000171: and local emergency plans.
p.000171: (2) NATIONAL COLLABORATION.—Coalitions consisting of one or more eligible entities under this section may,
p.000171: to the ex- tent practicable, collaborate with other coalitions consisting of one or more eligible entities under
p.000171: this section for purposes of national coordination and collaboration with respect to activi- ties to achieve
p.000171: the preparedness and response goals described under paragraphs (1), (3), (4), (5), and (6) of section 2802(b).
p.000171: (h) MAINTENANCE OF FUNDING.—
p.000171: (1) IN GENERAL.—An entity that receives an award under this section shall maintain expenditures for
p.000171: health care pre- paredness at a level that is not less than the average level of such expenditures
p.000171: maintained by the entity for the preceding 2 year period.
p.000171: (2) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to prohibit the use of awards under
p.000171: this section to pay salary and related expenses of public health and other professionals employed by
p.000171: State, local, or tribal agencies who are carrying out activities supported by such awards (regard- less of
p.000171: whether the primary assignment of such personnel is to carry out such activities).
p.000171: (i) PERFORMANCE AND ACCOUNTABILITY.—
p.000171: (1) IN GENERAL.—The requirements of section 319C–1(g), (i), (j), and (k) shall apply to entities
p.000171: receiving awards under this section (regardless of whether such entities are described under subsection
p.000171: (b)(1)(A) or (b)(2)(A)) in the same manner as such requirements apply to entities under section 319C–1.
p.000171: In submitting reports under this paragraph, a coalition shall in- clude information on the progress that
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p.000173: (A) IN GENERAL.—From amounts appropriated for a fiscal year under paragraph (1)(A) and not reserved under
p.000173: paragraph (1)(B)(i) or (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have
p.000173: com- pleted an application as described in subsection (b)(2)(B).
p.000173: (B) AMOUNT.—The Secretary shall determine the amount of an award to each entity described in
p.000173: subpara- graph (A) in the same manner as such amounts are deter- mined under section 319C–1(h).
p.000173: (4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
p.000173: (A) IN GENERAL.—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for
p.000173: a fiscal year and remaining unobligated at the end of such year shall remain available to such entity
p.000173: for the next fiscal year for the purposes for which such funds were provided.
p.000173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000173: Sec. 319C–3 PUBLIC HEALTH SERVICE ACT 174
p.000173:
p.000173: (B) FUNDS CONTINGENT ON ACHIEVING BENCHMARKS.— The continued availability of funds under subparagraph
p.000173: (A) with respect to an entity shall be contingent upon such entity achieving the benchmarks and submitting the
p.000173: pan- demic influenza plan as required under subsection (i).
p.000173: SEC. 319C–3. ø247d-3c¿ GUIDELINES FOR REGIONAL HEALTH CARE EMERGENCY PREPAREDNESS AND RESPONSE SYSTEMS.
p.000173: (a) PURPOSE.—It is the purpose of this section to identify and provide guidelines for regional systems of
p.000173: hospitals, health care fa- cilities, and other public and private sector entities, with varying levels of
p.000173: capability to treat patients and increase medical surge ca- pacity during, in advance of, and immediately
p.000173: following a public health emergency, including threats posed by one or more chem- ical, biological,
p.000173: radiological, or nuclear agents, including emerging infectious diseases.
p.000173: (b) GUIDELINES.—The Assistant Secretary for Preparedness and Response, in consultation with the Director of
p.000173: the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid
p.000173: Services, the Administrator of the Health Resources and Services Administration, the Commissioner of Food and
p.000173: Drugs, the Assistant Secretary for Mental Health and Sub- stance Use, the Assistant Secretary of Labor for
p.000173: Occupational Safe- ty and Health, the Secretary of Veterans Affairs, the heads of such other Federal agencies as
p.000173: the Secretary determines to be appro- priate, and State, local, Tribal, and territorial public health
p.000173: offi- cials, shall, not later than 2 years after the date of enactment of this section—
p.000173: (1) identify and develop a set of guidelines relating to prac- tices and protocols for all-hazards public health
p.000173: emergency pre- paredness and response for hospitals and health care facilities to provide appropriate patient care
p.000173: during, in advance of, or immediately following, a public health emergency, resulting from one or more
p.000173: chemical, biological, radiological, or nuclear agents, including emerging infectious diseases (which may in-
p.000173: clude existing practices, such as trauma care and medical surge capacity and capabilities), with respect to—
p.000173: (A) a regional approach to identifying hospitals and health care facilities based on varying capabilities and
p.000173: ca- pacity to treat patients affected by such emergency, includ- ing—
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p.000173: (i) the manner in which the system will coordinate with and integrate the partnerships and health care
p.000173: coalitions established under section 319C–2(b); and
p.000173: (ii) informing and educating appropriate first re- sponders and health care supply chain partners of the regional
p.000173: emergency preparedness and response capa- bilities and medical surge capacity of such hospitals and health
p.000173: care facilities in the community;
p.000173: (B) physical and technological infrastructure, labora- tory capacity, staffing, blood supply, and
p.000173: other supply chain needs, taking into account resiliency, geographic con- siderations, and rural considerations;
p.000173: (C) protocols or best practices for the safety and per- sonal protection of workers who handle human
p.000173: remains
p.000173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000175: PUBLIC HEALTH SERVICE ACT
p.000175: Sec. 319C–3
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p.000175: (2) make such guidelines available on the internet website of the Department of Health and Human Services in a manner
p.000175: that does not compromise national security; and
p.000175: (3) update such guidelines as appropriate, including based on input received pursuant to subsections (c) and (e) and
p.000175: infor- mation resulting from applicable reports required under the Pandemic and All-Hazards Preparedness and
p.000175: Advancing Inno- vation Act of 2019 (including any amendments made by such Act), to address new and emerging
p.000175: public health threats.
p.000175: (c) CONSIDERATIONS.—In identifying, developing, and updating guidelines under subsection (b), the Assistant
p.000175: Secretary for Pre- paredness and Response shall—
p.000175: (1) include input from hospitals and health care facilities (including health care coalitions under
p.000175: section 319C–2), State, local, Tribal, and territorial public health departments, and health care or
p.000175: subject matter experts (including experts with relevant expertise in chemical, biological, radiological, or
p.000175: nu- clear threats, including emerging infectious diseases), as the Assistant Secretary determines
p.000175: appropriate, to meet the goals under section 2802(b)(3);
p.000175: (2) consult and engage with appropriate health care pro- viders and professionals, including physicians,
p.000175: nurses, first re- sponders, health care facilities (including hospitals, primary care clinics, community health
p.000175: centers, mental health facilities, ambulatory care facilities, and dental health facilities), phar- macies,
p.000175: emergency medical providers, trauma care providers, environmental health agencies, public health laboratories,
p.000175: poi- son control centers, blood banks, tissue banks, and other ex- perts that the Assistant Secretary
p.000175: determines appropriate, to meet the goals under section 2802(b)(3);
p.000175: (3) consider feedback related to financial implications for hospitals, health care facilities, public
p.000175: health agencies, labora- tories, blood banks, tissue banks, and other entities engaged in regional preparedness
p.000175: planning to implement and follow such guidelines, as applicable; and
p.000175: (4) consider financial requirements and potential incen- tives for entities to prepare for, and respond
p.000175: to, public health emergencies as part of the regional health care emergency pre- paredness and response system.
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000175: (d) TECHNICAL ASSISTANCE.—The Assistant Secretary for Pre- paredness and Response, in consultation with the
p.000175: Director of the Centers for Disease Control and Prevention and the Assistant Sec- retary of Labor for
p.000175: Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guide-
p.000175: lines described in subsection (b).
p.000175: (e) DEMONSTRATION PROJECT FOR REGIONAL HEALTH CARE PREPAREDNESS AND RESPONSE SYSTEMS.—
p.000175: (1) IN GENERAL.—The Assistant Secretary for Prepared- ness and Response may establish a demonstration project
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p.000177: obligations and expenditures directly related to each activity under paragraphs (2) and (3), including a
p.000177: specific ac- counting of, and delineation between, obligations and expendi- tures incurred for the construction,
p.000177: renovation, equipping, and security upgrades of facilities and associated contracts under this subsection, and
p.000177: the obligations and expenditures incurred to establish and improve the situational awareness and bio-
p.000177: surveillance network under subsection (b), and shall identify the agency or agencies incurring such obligations
p.000177: and expendi- tures.
p.000177: (b) ESTABLISHMENT OF SYSTEMS OF PUBLIC HEALTH COMMU-
p.000177: NICATIONS AND SURVEILLANCE NETWORKS.—
p.000177: (1) IN GENERAL.—The Secretary, directly or through awards of grants, contracts, or cooperative
p.000177: agreements, shall provide for the establishment of an integrated system or sys- tems of public health
p.000177: alert communications and surveillance networks between and among—
p.000177: (A) Federal, State, and local public health officials;
p.000177: (B) public and private health-related laboratories, hos- pitals, poison control centers, immunization information
p.000177: systems, and other health care facilities; and
p.000177: (C) any other entities determined appropriate by the Secretary.
p.000177: (2) REQUIREMENTS.—The Secretary shall develop a plan to, and ensure that networks under paragraph (1) allow for
p.000177: the timely sharing and discussion, in a secure manner and in a form readily usable for analytical
p.000177: approaches, of essential in- formation concerning bioterrorism or another public health emergency, or
p.000177: recommended methods for responding to such an attack or emergency, allowing for coordination to maximize all- hazards
p.000177: medical and public health preparedness and response and to minimize duplication of effort.
p.000177: (3) STANDARDS.—
p.000177: (A) IN GENERAL.—Not later than 1 year after the date of the enactment of the Pandemic and All-Hazards Pre-
p.000177: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000177:
p.000177: paredness and Advancing Innovation Act of 2019, the Sec- retary, in cooperation with health care providers,
p.000177: State, local, Tribal, and territorial public health officials, and rel- evant Federal agencies (including the
p.000177: Office of the Na- tional Coordinator for Health Information Technology and the National Institute of Standards
p.000177: and Technology), shall, as necessary, adopt technical and reporting standards, in- cluding standards for
p.000177: interoperability as defined by section 3000, for networks under paragraph (1) and update such standards as
p.000177: necessary. Such standards shall be made available on the internet website of the Department of Health and
p.000177: Human Services, in a manner that does not compromise national security.
p.000177: (B) DEFERENCE TO STANDARDS DEVELOPMENT ORGANI- ZATIONS.—In adopting and implementing standards under this
p.000177: subsection and subsection (c), the Secretary shall give deference to standards published by standards develop-
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p.000177: (1) IN GENERAL.—The Secretary, in collaboration with State, local, and tribal public health
p.000177: officials, shall establish, and improve as applicable and appropriate, a near real-time electronic nationwide
p.000177: public health situational awareness capa- bility through an interoperable network of systems to share data and
p.000177: information to enhance early detection of, rapid re- sponse to, and management of, potentially
p.000177: catastrophic infec- tious disease outbreaks, novel emerging threats, and other public health emergencies
p.000177: that originate domestically or abroad. Such network shall be built on existing State situa- tional
p.000177: awareness systems or enhanced systems that enable such interoperability.
p.000177: (2) COORDINATION AND CONSULTATION.—In establishing
p.000177: and improving the network under paragraph (1), the Secretary shall—
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p.000177: (A) facilitate coordination among agencies within the Department of Health and Human Services that
p.000177: provide, or have the potential to provide, information and data to, and analyses for, the situational
p.000177: awareness and biosurveil- lance network under paragraph (1), including coordination among relevant agencies related
p.000177: to health care services, the facilitation of health information exchange (including the Office of the National
p.000177: Coordinator for Health Informa- tion Technology), and public health emergency prepared- ness and response; and
p.000177: (B) consult with the Secretary of Agriculture, the Sec- retary of Commerce (and the Director of the National
p.000177: In- stitute of Standards and Technology), the Secretary of De- fense, the Secretary of Homeland Security, the
p.000177: Secretary of Veterans Affairs, and the heads of other Federal agen- cies, as the Secretary determines
p.000177: appropriate.
p.000177: (3) ELEMENTS.—
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p.000179: PUBLIC HEALTH SERVICE ACT
p.000179: Sec. 319D
p.000179:
p.000179: (A) IN GENERAL.—The network described in paragraph
p.000179: (1) shall include data and information transmitted in a standardized format from—
p.000179: (i) State, local, and tribal public health entities, including public health laboratories;
p.000179: (ii) Federal health agencies;
p.000179: (iii) zoonotic disease monitoring systems;
p.000179: (iv) public and private sector health care entities, hospitals, pharmacies, poison control centers or profes-
p.000179: sional organizations in the field of poison control, im- munization information systems, community
p.000179: health centers, health centers, clinical laboratories, and pub- lic environmental health agencies, to the
p.000179: extent prac- ticable and provided that such data are voluntarily provided simultaneously to the Secretary
p.000179: and appro- priate State, local, and tribal public health agencies; and
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p.000179: as a part of the network.
p.000179: (B) PUBLIC MEETING.—
p.000179: (i) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness
p.000179: and Advancing Innovation Act of 2019, the Secretary shall convene a public meeting for pur- poses of
p.000179: discussing and providing input on the poten- tial goals, functions, and uses of the network described in
p.000179: paragraph (1) and incorporating the elements de- scribed in paragraph (3)(A).
p.000179: (ii) EXPERTS.—The public meeting shall include representatives of relevant Federal agencies (including
p.000179: representatives from the Office of the National Coordi- nator for Health Information Technology and the Na-
p.000179: tional Institute of Standards and Technology); State, local, Tribal, and territorial public health
p.000179: officials; stakeholders with expertise in biosurveillance and sit- uational awareness; stakeholders with expertise in
p.000179: ca- pabilities relevant to biosurveillance and situational awareness, such as experts in informatics and
p.000179: data analytics (including experts in prediction, modeling, or forecasting); and other representatives as the
p.000179: Sec- retary determines appropriate.
p.000179: (iii) TOPICS.—Such public meeting shall include a discussion of—
p.000179: (I) data elements, including minimal or essen- tial data elements, that are voluntarily provided for such
p.000179: network, which may include elements from public health and public and private health care entities, to the
p.000179: extent practicable;
p.000179: (II) standards and implementation specifica- tions that may improve the collection, analysis, and
p.000179: interpretation of data during a public health emergency;
p.000179: (III) strategies to encourage the access, ex- change, and use of information;
p.000179: (IV) considerations for State, local, Tribal, and territorial capabilities and infrastructure related to data
p.000179: exchange and interoperability;
p.000179: (V) privacy and security protections provided at the Federal, State, local, Tribal, and territorial levels, and by
p.000179: nongovernmental stakeholders; and
p.000179: (VI) opportunities for the incorporation of in- novative technologies to improve the network.
p.000179: (6) STRATEGY AND IMPLEMENTATION PLAN.—
p.000179: (A) IN GENERAL.—Not later than 18 months after the date of enactment of the Pandemic and All-Hazards
p.000179: Pre- paredness and Advancing Innovation Act of 2019, the Sec-
p.000179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000181: PUBLIC HEALTH SERVICE ACT
p.000181: Sec. 319D
p.000181:
p.000181: retary shall submit to the congressional committees of ju- risdiction a coordinated strategy and an
p.000181: accompanying im- plementation plan that—
p.000181: (i) is informed by the public meeting under para- graph (5)(B);
p.000181: (ii) includes a review and assessment of existing capabilities of the network and related infrastructure,
p.000181: including input provided by the public meeting under paragraph (5)(B);
p.000181: (iii) identifies and demonstrates the measurable steps the Secretary will carry out to—
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p.000183: disease outbreaks and public health emergencies; and
p.000183: (D) an implementation plan that may include measur- able steps to achieve the purposes described in paragraph
p.000183: (1).
p.000183: (3) USE OF FUNDS.—A State or consortium of States that receives an award under this subsection—
p.000183: (A) shall establish, enhance, or operate a coordinated public health situational awareness system for regional
p.000183: or Statewide early detection of, rapid response to, and man- agement of potentially catastrophic infectious
p.000183: disease out- breaks and public health emergencies;
p.000183: (B) may award grants or contracts to entities de- scribed in paragraph (1) within or serving such State to as-
p.000183: sist such entities in improving the operation of information technology systems, facilitating the secure
p.000183: exchange of data and information, and training personnel to enhance the operation of the system described in
p.000183: subparagraph (A); and
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p.000183: (C) may conduct a pilot program for the development of multi-State telehealth network test beds that
p.000183: build on, enhance, and securely link existing State and local tele- health programs to prepare for,
p.000183: monitor, respond to, and manage the events of public health emergencies, facilitate coordination and
p.000183: communication among medical, public health, and emergency response agencies, and provide medical
p.000183: services through telehealth initiatives within the
p.000183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000183: States that are involved in such a multi-State telehealth network test bed.
p.000183: (4) LIMITATION.—Information technology systems acquired or implemented using grants awarded under this section must
p.000183: be compliant with—
p.000183: (A) interoperability and other technological standards, as determined by the Secretary; and
p.000183: (B) data collection and reporting requirements for the network described in subsection (c).
p.000183: (5) TECHNICAL ASSISTANCE.—The Secretary may provide technical assistance to States, localities, Tribes, and
p.000183: territories or a consortium of States, localities, Tribes, and territories re- ceiving an award under this
p.000183: subsection regarding interoper- ability and the technical standards set forth by the Secretary.
p.000183: (e) TELEHEALTH ENHANCEMENTS FOR EMERGENCY RESPONSE.—
p.000183: (1) EVALUATION.—The Secretary, in consultation with the Federal Communications Commission and other relevant
p.000183: Fed- eral agencies, shall—
p.000183: (A) conduct an inventory of telehealth initiatives in ex- istence on the date of enactment of the Pandemic and All-
p.000183: Hazards Preparedness Act, including—
p.000183: (i) the specific location of network components;
p.000183: (ii) the medical, technological, and communica- tions capabilities of such components;
p.000183: (iii) the functionality of such components; and
p.000183: (iv) the capacity and ability of such components to handle increased volume during the response to a pub- lic health
p.000183: emergency;
p.000183: (B) identify methods to expand and interconnect the regional health information networks funded by the
p.000183: Sec- retary, the State and regional broadband networks funded through the rural health care support mechanism
p.000183: pilot program funded by the Federal Communications Commis- sion, and other telehealth networks;
p.000183: (C) evaluate ways to prepare for, monitor, respond rapidly to, or manage the events of, a public health emer-
p.000183: gency through the enhanced use of telehealth technologies, including mechanisms for payment or reimbursement for
p.000183: use of such technologies and personnel during public health emergencies;
p.000183: (D) identify methods for reducing legal barriers that deter health care professionals from providing
p.000183: telemedicine services, such as by utilizing State emergency health care professional credentialing
p.000183: verification systems, encour- aging States to establish and implement mechanisms to improve interstate
p.000183: medical licensure cooperation, facili- tating the exchange of information among States regarding investigations and
p.000183: adverse actions, and encouraging States to waive the application of licensing requirements during a public
p.000183: health emergency;
p.000183: (E) evaluate ways to integrate the practice of telemedi- cine within the National Disaster Medical System; and
p.000183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000185: PUBLIC HEALTH SERVICE ACT
p.000185: Sec. 319D
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p.000185: (F) promote greater coordination among existing Fed- eral interagency telemedicine and health information tech-
p.000185: nology initiatives.
p.000185: (2) REPORT.—Not later than 12 months after the date of enactment of the Pandemic and All-Hazards Preparedness
p.000185: Act, the Secretary shall prepare and submit a report to the Com- mittee on Health, Education, Labor, and
p.000185: Pensions of the Sen- ate and the Committee on Energy and Commerce of the House of Representatives regarding the
p.000185: findings and recommenda- tions pursuant to subparagraphs (A) through (F) of paragraph (1).
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p.000185: $161,800,000 for each of fiscal years 2019 through 2023.
p.000185: (j) DEFINITION.—For purposes of this section the term ‘‘bio- surveillance’’ means the process of gathering near
p.000185: real-time biologi- cal data that relates to human and zoonotic disease activity and
p.000185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000185: Sec. 319D–1 PUBLIC HEALTH SERVICE ACT 186
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p.000185: threats to human or animal health, in order to achieve early warn- ing and identification of such health threats,
p.000185: early detection and prompt ongoing tracking of health events, and overall situational awareness of disease
p.000185: activity.
p.000185: SEC. 319D–1. ø247d-4b¿ CHILDREN’S PREPAREDNESS UNIT.
p.000185: (a) ENHANCING EMERGENCY PREPAREDNESS FOR CHILDREN.— The Secretary, acting through the Director of the
p.000185: Centers for Dis- ease Control and Prevention (referred to in this subsection as the ‘‘Director’’), shall
p.000185: maintain an internal team of experts, to be known as the Children’s Preparedness Unit (referred to in
p.000185: this sub- section as the ‘‘Unit’’), to work collaboratively to provide guidance on the considerations for, and
p.000185: the specific needs of, children before, during, and after public health emergencies. The Unit shall inform the
p.000185: Director regarding emergency preparedness and response ef- forts pertaining to children at the Centers for
p.000185: Disease Control and Prevention.
p.000185: (b) EXPERTISE.—The team described in subsection (a) shall in- clude one or more pediatricians, which may be a
p.000185: developmental-be- havioral pediatrician, and may also include behavioral scientists, child psychologists,
p.000185: epidemiologists, biostatisticians, health commu- nications staff, and individuals with other areas of expertise, as the
p.000185: Secretary determines appropriate.
p.000185: (c) DUTIES.—The team described in subsection (a) may—
p.000185: (1) assist State, local, Tribal, and territorial emergency planning and response activities related to children,
p.000185: which may include developing, identifying, and sharing best practices;
p.000185: (2) provide technical assistance, training, and consultation to Federal, State, local, Tribal, and territorial public
p.000185: health of- ficials to improve preparedness and response capabilities with respect to the needs of children,
p.000185: including providing such tech- nical assistance, training, and consultation to eligible entities in order to
p.000185: support the achievement of measurable evidence- based benchmarks and objective standards applicable to sec-
p.000185: tions 319C–1 and 319C–2;
p.000185: (3) improve the utilization of methods to incorporate the needs of children in planning for and
p.000185: responding to a public health emergency, including public awareness of such methods;
p.000185: (4) coordinate with, and improve, public-private partner- ships, such as health care coalitions
p.000185: pursuant to sections 319C–2 and 319C–3, to address gaps and inefficiencies in emergency preparedness and
p.000185: response efforts for children;
p.000185: (5) provide expertise and input during the development of guidance and clinical recommendations to address the
p.000185: needs of children when preparing for, and responding to, public health emergencies, including pursuant to
p.000185: section 319C–3; and
p.000185: (6) carry out other duties related to preparedness and re- sponse activities for children, as the
p.000185: Secretary determines ap- propriate.
p.000185: SEC. 319E. ø247d–5¿ COMBATING ANTIMICROBIAL RESISTANCE.
p.000185: (a) TASK FORCE.—
p.000185: (1) IN GENERAL.—The Secretary shall establish an Anti- microbial Resistance Task Force to provide advice
p.000185: and rec- ommendations to the Secretary and coordinate Federal pro-
p.000185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000187: PUBLIC HEALTH SERVICE ACT
p.000187: Sec. 319E
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p.000189: SEC. 319F. ø247d–6¿ PUBLIC HEALTH COUNTERMEASURES TO A BIO- TERRORIST ATTACK.
p.000189: (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL RESPONSE CURRICULA AND TRAINING.—
p.000189: (1) IN GENERAL.—The Secretary, in collaboration with the Secretary of Defense, and in consultation with
p.000189: relevant public and private entities, shall develop core health and medical re- sponse curricula and trainings by
p.000189: adapting applicable existing curricula and training programs to improve responses to public health emergencies.
p.000189: (2) CURRICULUM.—The public health and medical response training program may include course work related to—
p.000189: (A) medical management of casualties, taking into ac- count the needs of at-risk individuals;
p.000189: (B) public health aspects of public health emergencies;
p.000189: (C) mental health aspects of public health emer- gencies;
p.000189: (D) national incident management, including coordina- tion among Federal, State, local, tribal, international agen-
p.000189: cies, and other entities; and
p.000189: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000191: PUBLIC HEALTH SERVICE ACT
p.000191: Sec. 319F
p.000191:
p.000191: (E) protecting health care workers and health care first responders from workplace exposures during a public
p.000191: health emergency.
p.000191: (3) PEER REVIEW.—On a periodic basis, products prepared as part of the program shall be rigorously
p.000191: tested and peer-re- viewed by experts in the relevant fields.
p.000191: (4) CREDIT.—The Secretary and the Secretary of Defense shall—
p.000191: (A) take into account continuing professional education requirements of public health and healthcare professions;
p.000191: and
p.000191: (B) cooperate with State, local, and tribal accrediting agencies and with professional associations in
p.000191: arranging for students enrolled in the program to obtain continuing professional education credit for program
p.000191: courses.
p.000191: (5) DISSEMINATION AND TRAINING.—
p.000191: (A) IN GENERAL.—The Secretary may provide for the dissemination and teaching of the materials described
p.000191: in paragraphs (1) and (2) by appropriate means, as deter- mined by the Secretary.
p.000191: (B) CERTAIN ENTITIES.—The education and training ac- tivities described in subparagraph (A) may be carried out
p.000191: by Federal public health, medical, or dental entities, ap- propriate educational entities, professional
p.000191: organizations and societies, private accrediting organizations, and other nonprofit institutions or entities
p.000191: meeting criteria estab- lished by the Secretary.
p.000191: (C) GRANTS AND CONTRACTS.—In carrying out this sub- section, the Secretary may carry out activities directly or
p.000191: through the award of grants and contracts, and may enter into interagency agreements with other Federal agencies.
p.000191: (b) ADVICE TO THE FEDERAL GOVERNMENT.—
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p.000191: struck. Also the letter ‘‘A’’ in the word ‘‘At-risk’’ in the inserted text probably should be lowercase type.
p.000191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000191: Sec. 319F PUBLIC HEALTH SERVICE ACT 192
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p.000191: (B) DUTIES.—The Advisory Committee shall provide recommendations regarding—
p.000191: (i) the preparedness of the health care (including mental health care) system to respond to public health
p.000191: emergencies as they relate to at-risk individuals;
p.000191: (ii) needed changes to the health care and emer- gency medical service systems and emergency medical services
p.000191: protocols to meet the special needs of at-risk individuals; and
p.000191: (iii) changes, if necessary, to the national stockpile under section 121 of the Public Health Security and
p.000191: Bioterrorism Preparedness and Response Act of 2002 to meet the emergency health security of at-risk indi-
p.000191: viduals.
p.000191: (C) COMPOSITION.—The Advisory Committee shall be composed of such Federal officials as may be appropriate
p.000191: to address the special needs of the diverse population groups of at-risk populations.
p.000191: (D) TERMINATION.—The Advisory Committee termi- nates six years after the date of the enactment of the Pub- lic
p.000191: Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002.
p.000191: (3) EMERGENCY PUBLIC INFORMATION AND COMMUNICA- TIONS ADVISORY COMMITTEE.—
p.000191: (A) IN GENERAL.—For purposes of paragraph (1), the Secretary shall establish an advisory committee
p.000191: to be known as the Emergency Public Information and Commu- nications Advisory Committee (referred to in this
p.000191: para- graph as the ‘‘EPIC Advisory Committee’’).
p.000191: (B) DUTIES.—The EPIC Advisory Committee shall make recommendations to the Secretary and report on ap-
p.000191: propriate ways to communicate public health information regarding bioterrorism and other public health
p.000191: emer- gencies to the public.
p.000191: (C) COMPOSITION.—The EPIC Advisory Committee shall be composed of individuals representing a diverse
p.000191: group of experts in public health, medicine, communica- tions, behavioral psychology, and other areas
p.000191: determined appropriate by the Secretary.
p.000191: (D) DISSEMINATION.—The Secretary shall review the recommendations of the EPIC Advisory Committee and en- sure
p.000191: that appropriate information is disseminated to the public.
p.000191: (E) TERMINATION.—The EPIC Advisory Committee ter- minates one year after the date of the enactment of Public Health
p.000191: Security and Bioterrorism Preparedness and Re- sponse Act of 2002.
p.000191: (c) EXPANSION OF EPIDEMIC INTELLIGENCE SERVICE PRO- GRAM.—The Secretary may establish 20 officer
p.000191: positions in the Epi- demic Intelligence Service Program, in addition to the number of the officer positions
p.000191: offered under such Program in 2006, for indi- viduals who agree to participate, for a period of not
p.000191: less than 2 years, in the Career Epidemiology Field Officer program in a State, local, or tribal health department
p.000191: that serves a health professional
p.000191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000193: school or health department, and how such activities may be improved;
p.000193: (C) prior to developing new materials or trainings, evaluate and utilize relevant materials and trainings
p.000193: de- veloped by others Centers; and
p.000193: (D) evaluate community impact and the effectiveness of any newly developed materials or trainings.
p.000193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000193: Sec. 319F PUBLIC HEALTH SERVICE ACT 194
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p.000193: (7) PUBLIC HEALTH SYSTEMS RESEARCH.—In consultation with relevant public and private entities, the
p.000193: Secretary shall define the existing knowledge base for public health prepared- ness and response systems, and
p.000193: establish a research agenda based on Federal, State, local, and tribal public health pre- paredness
p.000193: priorities. As a condition of receiving funding from the Secretary under this subsection, a Center shall
p.000193: conduct public health systems research that is consistent with the agenda described under this paragraph.
p.000193: (e) ACCELERATED RESEARCH AND DEVELOPMENT ON PRIORITY PATHOGENS AND COUNTERMEASURES.—
p.000193: (1) IN GENERAL.—With respect to pathogens of potential use in a bioterrorist attack, and other agents
p.000193: that may cause a public health emergency, the Secretary, taking into consider- ation any recommendations of the
p.000193: working group under sub- section (a), shall conduct, and award grants, contracts, or coop- erative agreements for,
p.000193: research, investigations, experiments, demonstrations, and studies in the health sciences relating to—
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p.000193: (A) the epidemiology and pathogenesis of such patho- gens;
p.000193: (B) the sequencing of the genomes, or other DNA anal- ysis, or other comparative analysis, of priority pathogens
p.000193: (as determined by the Director of the National Institutes of Health in consultation with the working
p.000193: group estab- lished in subsection (a)), in collaboration and coordination with the activities of the
p.000193: Department of Defense and the Joint Genome Institute of the Department of Energy;
p.000193: (C) the development of priority countermeasures; and
p.000193: (D) other relevant areas of research;
p.000193: with consideration given to the needs of children and other vul- nerable populations.
p.000193: (2) PRIORITY.—The Secretary shall give priority under this section to the funding of research and other studies related
p.000193: to priority countermeasures.
p.000193: (3) ROLE OF DEPARTMENT OF VETERANS AFFAIRS.—In car- rying out paragraph (1), the Secretary shall consider using
p.000193: the biomedical research and development capabilities of the De- partment of Veterans Affairs, in conjunction
p.000193: with that Depart- ment’s affiliations with health-professions universities. When advantageous to the Government
p.000193: in furtherance of the pur- poses of such paragraph, the Secretary may enter into coopera- tive agreements with
p.000193: the Secretary of Veterans Affairs to achieve such purposes.
p.000193: (4) PRIORITY COUNTERMEASURES.—For purposes of this sec- tion, the term ‘‘priority countermeasure’’ means a drug,
p.000193: biologi- cal product, device, vaccine, vaccine adjuvant, antiviral, or di- agnostic test that the Secretary
p.000193: determines to be—
p.000193: (A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to
p.000193: section 351A(a)(1), or harm from any other agent that may cause a public health emergency; or
p.000193: (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences
p.000193: or death
p.000193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000195: PUBLIC HEALTH SERVICE ACT
p.000195: Sec. 319F–1
p.000195:
p.000195: and may be caused by the administering of a drug, biologi- cal product, device, vaccine, vaccine adjuvant, antiviral,
p.000195: or diagnostic test that is a priority under subparagraph (A).
p.000195: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000195: (1) FISCAL YEAR 2007.—There are authorized to be appro- priated to carry out this section for fiscal year 2007—
p.000195: (A) to carry out subsection (a)—
p.000195: (i) $5,000,000 to carry out paragraphs (1) through (4); and
p.000195: (ii) $7,000,000 to carry out paragraph (5);
p.000195: (B) to carry out subsection (c), $3,000,000; and
p.000195: (C) to carry out subsection (d), $31,000,000, of which
p.000195: $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection.
p.000195: (2) SUBSEQUENT FISCAL YEARS.—There are authorized to be appropriated such sums as may be necessary to carry out this
p.000195: section for fiscal year 2008 and each subsequent fiscal year.
p.000195: SEC. 319F–1. ø247d–6a¿ AUTHORITY FOR USE OF CERTAIN PROCE- DURES REGARDING QUALIFIED COUNTERMEASURE
p.000195: RE- SEARCH AND DEVELOPMENT ACTIVITIES. 21
p.000195: (a) IN GENERAL.—
p.000195: (1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures
p.000195: under section 319F(e), the Secretary may conduct and support such activities in accordance with this
p.000195: section and, in consultation with the Director of the National Institutes of Health, as part of the program under
p.000195: section 446, if the activities concern qualified countermeasures.
p.000195: (2) DEFINITIONS.—In this section:
p.000195: (A) QUALIFIED COUNTERMEASURE.—The term ‘‘quali- fied countermeasure’’ means a drug (as that term is de-
p.000195: fined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological
p.000195: product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is
p.000195: defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the
p.000195: Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Home- land
p.000195: Security Act of 2002)—
p.000195: (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that
p.000195: cause an infectious disease) or toxin, chemical, radio- logical, or nuclear agent that may cause a
p.000195: public health emergency affecting national security;
p.000195: (ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health
p.000195: consequences or death and may be caused by admin- istering a drug, biological product, or device that
p.000195: is used as described in this subparagraph; or
p.000195:
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p.000195: January 30, 2020
p.000195: 21 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–1 and related
p.000195: provisions of law. Section 5 is included in the appendix to this compilation.
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: 3110(a)(3) of such title) of such official;
p.000201: (D) does not discriminate for or against an individual because of the exercise of any activity described
p.000201: in para- graph (9) or (10) of section 2302(b) of such title; and
p.000201: (E) accords a preference, among equally qualified per- sons, to persons who are preference eligibles (as defined in
p.000201: section 2108(3) of such title).
p.000201: (3) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for
p.000201: appointments under this subsection.
p.000201: (f) ACTIONS COMMITTED TO AGENCY DISCRETION.—Actions by the Secretary under the authority of this section are
p.000201: committed to agency discretion.
p.000201: SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECU-
p.000201: RITY COUNTERMEASURE PROCUREMENTS. 22
p.000201: (a) STRATEGIC NATIONAL STOCKPILE.—
p.000201: (1) IN GENERAL.—The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and
p.000201: the Di- rector of the Centers for Disease Control and Prevention, and in coordination with the Secretary
p.000201: of Homeland Security (re- ferred to in this section as the ‘‘Homeland Security Secretary’’), shall maintain a
p.000201: stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other
p.000201: supplies in such numbers, types, and amounts as are determined con- sistent with section 2811 by the
p.000201: Secretary to be appropriate and practicable, taking into account other available sources, to provide for and
p.000201: optimize the emergency health security of the United States, including the emergency health security of chil-
p.000201: dren and other vulnerable populations, in the event of a bioter- rorist attack or other public health emergency and, as
p.000201: informed by existing recommendations of, or consultations with, the Public Health Emergency Medical
p.000201: Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the
p.000201: contents of such stockpile or stockpiles based on the review conducted under paragraph (2).
p.000201: (2) THREAT-BASED REVIEW.—
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p.000201: January 30, 2020
p.000201: 22 Section 5 of Public Law 108–276 (118 Stat. 860) requires various reports regarding section 319F–2 and related
p.000201: provisions of law. Section 5 is included in the appendix to this compilation.
p.000201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 202
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p.000201: January 30, 2020
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p.000201: (A) IN GENERAL.—The Secretary shall conduct an an- nual threat-based review (taking into account at-risk indi-
p.000201: viduals) of the contents of the stockpile under paragraph (1), including non-pharmaceutical supplies, and,
p.000201: in con- sultation with the Public Health Emergency Medical Coun- termeasures Enterprise established under section
p.000201: 2811–1, review contents within the stockpile and assess whether such contents are consistent with the
p.000201: recommendations made pursuant to section 2811–1(c)(1)(A). Such review shall be submitted on June 15,
p.000201: 2019, and on March 15 of each year thereafter, to the Committee on Health, Edu- cation, Labor, and
p.000201: Pensions and the Committee on Appro- priations of the Senate and the Committee on Energy and Commerce and the
p.000201: Committee on Appropriations of the House of Representatives, in a manner that does not com- promise national
p.000201: security.
p.000201: (B) ADDITIONS, MODIFICATIONS, AND REPLENISH- MENTS.—Each annual threat-based review under subpara-
p.000201: graph (A) shall, for each new or modified countermeasure procurement or replenishment, provide—
p.000201: (i) information regarding—
p.000201: (I) the quantities of the additional or modified countermeasure procured for, or contracted to be procured for,
p.000201: the stockpile;
p.000201: (II) planning considerations for appropriate manufacturing capacity and capability to meet the goals of such
p.000201: additions or modifications (without disclosing proprietary information), including con- sideration of the effect
p.000201: such additions or modifica- tions may have on the availability of such prod- ucts and ancillary medical
p.000201: supplies in the health care system;
p.000201: (III) the presence or lack of a commercial market for the countermeasure at the time of pro- curement;
p.000201: (IV) the emergency health security threat or threats such countermeasure procurement is in- tended to
p.000201: address, including whether such pro- curement is consistent with meeting emergency health security needs
p.000201: associated with such threat or threats;
p.000201: (V) an assessment of whether the emergency health security threat or threats described in sub- clause (IV)
p.000201: could be addressed in a manner that better utilizes the resources of the stockpile and permits the
p.000201: greatest possible increase in the level of emergency preparedness to address such threats;
p.000201: (VI) whether such countermeasure is replen- ishing an expiring or expired countermeasure, is a different
p.000201: countermeasure with the same indication that is replacing an expiring or expired counter- measure, or is a new
p.000201: addition to the stockpile;
p.000201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000203: 203
p.000203: PUBLIC HEALTH SERVICE ACT
p.000203: Sec. 319F–2
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p.000203: (VII) a description of how such additions or modifications align with projected investments under
p.000203: previous countermeasures budget plans under section 2811(b)(7), including expected life- cycle costs,
p.000203: expenditures related to counter- measure procurement to address the threat or threats described in
p.000203: subclause (IV), replenishment dates (including the ability to extend the max- imum shelf life of a
p.000203: countermeasure), and the manufacturing capacity required to replenish such countermeasure; and
p.000203: (VIII) appropriate protocols and processes for the deployment, distribution, or dispensing of the
p.000203: countermeasure at the State and local level, in- cluding plans for relevant capabilities of State and local
p.000203: entities to dispense, distribute, and admin- ister the countermeasure; and
p.000203: (ii) an assurance, which need not be provided in advance of procurement, that for each countermeasure procured
p.000203: or replenished under this subsection, the Secretary completed a review addressing each item listed
p.000203: under this subsection in advance of such pro- curement or replenishment.
p.000203: (3) PROCEDURES.—The Secretary, in managing the stock- pile under paragraph (1), shall—
p.000203: (A) consult with the working group under section 319F(a) and the Public Health Emergency Medical
p.000203: Coun- termeasures Enterprise established under section 2811–1;
p.000203: (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and
p.000203: accounting, and for the physical security of the stockpile;
p.000203: (C) in consultation with Federal, State, and local offi- cials, take into consideration the timing and
p.000203: location of special events, and the availability, deployment, dis- pensing, and administration of
p.000203: countermeasures;
p.000203: (D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that
p.000203: emerging threats, advanced technologies, and new countermeasures are adequately considered and that the potential
p.000203: depletion of countermeasures currently in the stockpile is identified and appropriately addressed, including
p.000203: through necessary replenishment;
p.000203: (E) devise plans for effective and timely supply-chain management of the stockpile, in consultation with
p.000203: the Di- rector of the Centers for Disease Control and Prevention, the Assistant Secretary for Preparedness
p.000203: and Response, the Secretary of Transportation, the Secretary of Home- land Security, the Secretary of
p.000203: Veterans Affairs, and the heads of other appropriate Federal agencies; State, local, Tribal, and territorial
p.000203: agencies; and the public and private health care infrastructure, as applicable, taking into ac- count the
p.000203: manufacturing capacity and other available sources of products and appropriate alternatives to sup-
p.000203: plies in the stockpile;
p.000203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000203: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 204
p.000203:
p.000203: (F) deploy the stockpile as required by the Secretary of Homeland Security to respond to an actual or potential
p.000203: emergency;
p.000203: (G) deploy the stockpile at the discretion of the Sec- retary to respond to an actual or potential
p.000203: public health emergency or other situation in which deployment is nec- essary to protect the public health or
p.000203: safety;
p.000203: (H) ensure the adequate physical security of the stock-
p.000203: pile;
p.000203: (I) ensure that each countermeasure or product under
p.000203: consideration for procurement pursuant to this subsection receives the same consideration regardless of whether
p.000203: such countermeasure or product receives or had received fund- ing under section 319L, including with respect to
p.000203: whether the countermeasure or product is most appropriate to meet the emergency health security needs of the United
p.000203: States; and
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p.000203: January 30, 2020
p.000203: (J) provide assistance, including technical assistance, to maintain and improve State and local public health pre-
p.000203: paredness capabilities to distribute and dispense medical countermeasures and products from the stockpile,
p.000203: as ap- propriate.
p.000203: (4) UTILIZATION GUIDELINES.—The Secretary shall ensure timely and accurate recommended utilization guidelines
p.000203: for qualified countermeasures (as defined in section 319F–1), qualified pandemic and epidemic products
p.000203: (as defined in sec- tion 319F–3), and security countermeasures (as defined in sub- section (c)), including for such
p.000203: products in the stockpile.
p.000203: (5) GAO REPORT.—
p.000203: (A) IN GENERAL.—Not later than 3 years after the date of enactment of the Pandemic and All-Hazards Prepared-
p.000203: ness and Advancing Innovation Act of 2019, and every 5 years thereafter, the Comptroller General of the
p.000203: United States shall conduct a review of any changes to the con- tents or management of the stockpile
p.000203: since January 1, 2015. Such review shall include—
p.000203: (i) an assessment of the comprehensiveness and completeness of each annual threat-based review under
...

p.000203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000205: 205
p.000205: PUBLIC HEALTH SERVICE ACT
p.000205: Sec. 319F–2
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p.000205: (iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dis-
p.000205: pensing of countermeasures procured, modified, or re- plenished under paragraph (1), including whether
p.000205: such plans were developed prior to procurement, modi- fication, or replenishment;
p.000205: (iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that re-
p.000205: ceived advanced research and development funding from the Biomedical Advanced Research and Develop- ment
p.000205: Authority;
p.000205: (v) an analysis of how such procurement decisions made progress toward meeting emergency health secu- rity needs
p.000205: related to the identified threats for counter- measures added, modified, or replenished under para- graph (1);
p.000205: (vi) a description of the resources expended re- lated to the procurement of countermeasures (includ- ing
p.000205: additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of
p.000205: the stockpile to meet emergency health secu- rity needs;
p.000205: (vii) an assessment of the extent to which addi- tions, modifications, and replenishments reviewed
p.000205: under paragraph (2) align with previous relevant re- ports or reviews by the Secretary or the
p.000205: Comptroller General;
p.000205: (viii) with respect to any change in the Federal or- ganizational management of the stockpile, an assess- ment
p.000205: and comparison of the processes affected by such change, including planning for potential counter- measure
p.000205: deployment, distribution, or dispensing capa- bilities and processes related to procurement decisions, use of
p.000205: stockpiled countermeasures, and use of re- sources for such activities; and
p.000205: (ix) an assessment of whether the processes and procedures described by the Secretary pursuant to sec- tion
p.000205: 403(b) of the Pandemic and All-Hazards Pre- paredness and Advancing Innovation Act of 2019 are
p.000205: sufficient to ensure countermeasures and products under consideration for procurement pursuant to sub-
p.000205: section (a) receive the same consideration regardless of whether such countermeasures and products receive or had
p.000205: received funding under section 319L, including with respect to whether such countermeasures and products
p.000205: are most appropriate to meet the emergency health security needs of the United States.
p.000205: (B) SUBMISSION.—Not later than 6 months after com- pleting a classified version of the review under
p.000205: subpara- graph (A), the Comptroller General shall submit an un- classified version of the review to the
p.000205: congressional com- mittees of jurisdiction.
p.000205: (b) SMALLPOX VACCINE DEVELOPMENT.—
p.000205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000205: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 206
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p.000205: (1) IN GENERAL.—The Secretary shall award contracts, enter into cooperative agreements, or carry out
p.000205: such other ac- tivities as may reasonably be required in order to ensure that the stockpile under
p.000205: subsection (a) includes an amount of vac- cine against smallpox as determined by such Secretary to be
p.000205: sufficient to meet the health security needs of the United States.
p.000205: (2) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to limit the private distribution, purchase,
p.000205: or sale of vaccines from sources other than the stockpile described in subsection (a).
p.000205: (c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CER- TAIN COUNTERMEASURES; AVAILABILITY OF
p.000205: SPECIAL RESERVE FUND.—
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p.000205: U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(h))) that—
p.000205: (i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of
p.000205: the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical,
p.000205: radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, miti-
p.000205: gate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may
p.000205: be caused by administering a drug, biological product, or device against such an agent;
p.000205: (II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and
p.000205: (III)(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act or licensed under
p.000205: section 351 of this Act; or
p.000205: (bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical ex-
p.000205: perience or research data (including data, if available, from pre-clinical and clinical trials) support a
p.000205: reason- able conclusion that the countermeasure will qualify for approval or licensing within 10 years after the
p.000205: date of a determination under paragraph (5); or
p.000205: (ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act.
p.000205: (2) DETERMINATION OF MATERIAL THREATS.—
p.000205: (A) MATERIAL THREAT.—The Homeland Security Sec- retary, in consultation with the Secretary and the heads of other
p.000205: agencies as appropriate, shall on an ongoing basis—
p.000205: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000207: PUBLIC HEALTH SERVICE ACT
p.000207: Sec. 319F–2
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p.000207: January 30, 2020
p.000207: (i) assess current and emerging threats of chem- ical, biological, radiological, and nuclear agents; and
p.000207: (ii) determine which of such agents present a ma- terial threat against the United States population suf- ficient to
p.000207: affect national security.
...

p.000215: (2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RE- SEARCH AND DEVELOPMENT.—The Secretary may
p.000215: utilize not more than 50 percent of the amounts authorized to be appro- priated under paragraph (1) to carry
p.000215: out section 319L (related to the Biomedical Advanced Research and Development Au- thority). Amounts authorized
p.000215: to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized
p.000215: to be appropriated to carry out such sec- tion.
p.000215: (3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the spe- cial reserve fund shall not be used to pay costs other than
p.000215: pay- ments made by the Secretary to a vendor for advanced develop- ment (under section 319L) or for procurement
p.000215: of a security countermeasure under subsection (c)(7).
p.000215: (4) REPORT ON SECURITY COUNTERMEASURE PROCURE- MENT.—Not later than March 1 of each year in which the
p.000215: Sec- retary determines that the amount of funds available for pro- curement of security
p.000215: countermeasures is less than
p.000215: $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health,
p.000215: Education, Labor, and Pensions of the Senate and the Committee on Ap- propriations and the Committee on
p.000215: Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for
p.000215: procurement and the impact such amount of funding will have—
p.000215: (A) in meeting the security countermeasure needs identified under this section; and
p.000215: (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan
p.000215: (pursuant to section 2811(d)).
p.000215: (5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Sec- retary, acting through the Director of the Biomedical
p.000215: Advanced Research and Development Authority, shall carry out the pro- grams funded by the special reserve fund
p.000215: (for the procurement of security countermeasures under subsection (c) and for car- rying out section 319L),
p.000215: including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and
p.000215: section 319L.
p.000215: (h) DEFINITIONS.—In this section:
p.000215: (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a).
p.000215: (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any
p.000215: appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation
p.000215: made available pur- suant to subsection (g)(1).
p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000217: PUBLIC HEALTH SERVICE ACT
p.000217: Sec. 319F–3
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p.000217: (A) In the case of a covered person who is a manufac- turer or distributor of the covered countermeasure
p.000217: in- volved, the immunity applies without regard to whether such countermeasure was administered to or used
p.000217: by an individual in accordance with the conditions described in paragraph (3)(C).
p.000217: (B) In the case of a covered person who is a program planner or qualified person with respect to the
p.000217: administra- tion or use of the covered countermeasure, the scope of im- munity includes circumstances in which
p.000217: the counter- measure was administered to or used by an individual in circumstances in which the
p.000217: covered person reasonably could have believed that the countermeasure was adminis- tered or used in accordance
p.000217: with the conditions described in paragraph (3)(C).
p.000217: (5) EFFECT OF DISTRIBUTION METHOD.—The provisions of this section apply to a covered countermeasure
p.000217: regardless of whether such countermeasure is obtained by donation, com- mercial sale, or any other means
p.000217: of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the dec- laration
p.000217: under such subsection provides that subsection (a) ap- plies only to covered countermeasures obtained through a par-
p.000217: ticular means of distribution.
p.000217: (6) REBUTTABLE PRESUMPTION.—For purposes of paragraph (1), there shall be a rebuttable presumption that any
p.000217: adminis- tration or use, during the effective period of the emergency dec- laration by the Secretary under
p.000217: subsection (b), of a covered countermeasure shall have been for the category or categories of diseases,
p.000217: health conditions, or threats to health with respect to which such declaration was issued.
p.000217: (b) DECLARATION BY SECRETARY.—
p.000217: (1) AUTHORITY TO ISSUE DECLARATION.—Subject to para- graph (2), if the Secretary makes a determination
p.000217: that a dis- ease or other health condition or other threat to health con- stitutes a public health
p.000217: emergency, or that there is a credible risk that the disease, condition, or threat may in the future
p.000217: constitute such an emergency, the Secretary may make a dec- laration, through publication in the Federal
p.000217: Register, recom- mending, under conditions as the Secretary may specify, the manufacture, testing,
p.000217: development, distribution, administra- tion, or use of one or more covered countermeasures, and stat- ing that
p.000217: subsection (a) is in effect with respect to the activities so recommended.
p.000217: (2) CONTENTS.—In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered
p.000217: counter- measure specified in the declaration—
p.000217: (A) the category or categories of diseases, health condi- tions, or threats to health for which the Secretary
p.000217: rec- ommends the administration or use of the countermeasure;
p.000217: (B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect,
p.000217: which period or periods may be designated by dates, or by mile- stones or other description of events,
p.000217: including factors specified in paragraph (6);
p.000217: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000219: PUBLIC HEALTH SERVICE ACT
p.000219: Sec. 319F–3
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p.000221: January 30, 2020
p.000221: (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that
p.000221: the harm will outweigh the benefit.
p.000221: (B) RULE OF CONSTRUCTION.—The criterion stated in subparagraph (A) shall be construed as establishing
p.000221: a standard for liability that is more stringent than a stand- ard of negligence in any form or recklessness.
p.000221: (2) AUTHORITY TO PROMULGATE REGULATORY DEFINITION.—
p.000221: (A) IN GENERAL.—The Secretary, in consultation with the Attorney General, shall promulgate regulations, which may
p.000221: be promulgated through interim final rules, that fur- ther restrict the scope of actions or omissions by a covered
p.000221: person that may qualify as ‘‘willful misconduct’’ for pur- poses of subsection (d).
p.000221: (B) FACTORS TO BE CONSIDERED.—In promulgating the regulations under this paragraph, the Secretary, in con-
p.000221: sultation with the Attorney General, shall consider the need to define the scope of permissible civil
p.000221: actions under subsection (d) in a way that will not adversely affect the public health.
p.000221: (C) TEMPORAL SCOPE OF REGULATIONS.—The regula- tions under this paragraph may specify the temporal effect that
p.000221: they shall be given for purposes of subsection (d).
p.000221: (D) INITIAL RULEMAKING.—Within 180 days after the enactment of the Public Readiness and Emergency Pre-
p.000221: paredness Act, the Secretary, in consultation with the At- torney General, shall commence and complete an
p.000221: initial rulemaking process under this paragraph.
p.000221: (3) PROOF OF WILLFUL MISCONDUCT.—In an action under subsection (d), the plaintiff shall have the burden of
p.000221: proving by clear and convincing evidence willful misconduct by each cov- ered person sued and that such
p.000221: willful misconduct caused death or serious physical injury.
p.000221: (4) DEFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO SECRETARY’S DECLARATION.—Notwithstanding any other
p.000221: provi- sion of law, a program planner or qualified person shall not have engaged in ‘‘willful misconduct’’ as
p.000221: a matter of law where such program planner or qualified person acted consistent with applicable directions,
p.000221: guidelines, or recommendations by the Secretary regarding the administration or use of a covered
p.000221: countermeasure that is specified in the declaration under sub- section (b), provided either the Secretary, or a
p.000221: State or local health authority, was provided with notice of information re- garding serious physical
p.000221: injury or death from the administra- tion or use of a covered countermeasure that is material to the plaintiff’s
p.000221: alleged loss within 7 days of the actual discovery of such information by such program planner or qualified
p.000221: person.
p.000221: (5) EXCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER OR DISTRIBUTOR.—
p.000221: (A) IN GENERAL.—If an act or omission by a manufac- turer or distributor with respect to a covered counter-
p.000221: measure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to
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p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
p.000225: right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law
p.000225: or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United
p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
p.000225: section, or any amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed
p.000225: to affect the National Vaccine In- jury Compensation Program under title XXI of this Act.
p.000225: (i) DEFINITIONS.—In this section:
p.000225: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means—
p.000225: (A) a qualified pandemic or epidemic product (as de- fined in paragraph (7));
p.000225: (B) a security countermeasure (as defined in section 319F–2(c)(1)(B)); or
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000227: PUBLIC HEALTH SERVICE ACT
p.000227: Sec. 319F–3
p.000227:
p.000227: (C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21
p.000227: U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or device
p.000227: (as such term is de- fined by section 201(h) of the Federal Food, Drug and Cos- metic Act (21 U.S.C. 321(h))
p.000227: that is authorized for emer- gency use in accordance with section 564, 564A, or 564B of the Federal Food,
p.000227: Drug, and Cosmetic Act.
p.000227: (2) COVERED PERSON.—The term ‘‘covered person’’, when used with respect to the administration or use of
p.000227: a covered countermeasure, means—
p.000227: (A) the United States; or
p.000227: (B) a person or entity that is—
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p.000227:
p.000227: Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological prod- uct (as such term is defined by section
p.000227: 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic
p.000227: Act (21 U.S.C. 321(h)) that is—
p.000227: (A)(i) a product manufactured, used, designed, devel- oped, modified, licensed, or procured—
p.000227: (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or
p.000227: (II) to limit the harm such pandemic or epidemic might otherwise cause;
p.000227: (ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate,
p.000227: pre- vent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause
p.000227: (i); or
p.000227: (iii) 23 a product or technology intended to enhance the use or effect of a drug, biological product, or device
p.000227: described in clause (i) or (ii); and
p.000227: (B)(i) approved or cleared under chapter V of the Fed- eral Food, Drug, and Cosmetic Act or licensed under
p.000227: sec- tion 351 of this Act;
p.000227: (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an
p.000227: exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; or
p.000227: (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and
p.000227: Cosmetic Act.
p.000227: (8) QUALIFIED PERSON.—The term ‘‘qualified person’’, when used with respect to the administration or use of a
p.000227: covered countermeasure, means—
p.000227: (A) a licensed health professional or other individual who is authorized to prescribe, administer, or
p.000227: dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered,
p.000227: or dis- pensed; or
p.000227: (B) a person within a category of persons so identified in a declaration by the Secretary under subsection (b).
p.000227: (9) SECURITY COUNTERMEASURE.—The term ‘‘security coun- termeasure’’ has the meaning given such term in section 319F–
p.000227: 2(c)(1)(B).
p.000227: (10) SERIOUS PHYSICAL INJURY.—The term ‘‘serious phys- ical injury’’ means an injury that—
p.000227: (A) is life threatening;
p.000227: (B) results in permanent impairment of a body func- tion or permanent damage to a body structure; or
p.000227: (C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or per-
p.000227: manent damage to a body structure.
p.000227: SEC. 319F–4. ø247d–6e¿ COVERED COUNTERMEASURE PROCESS.
p.000227: (a) ESTABLISHMENT OF FUND.—Upon the issuance by the Sec- retary of a declaration under section 319F–3(b), there
p.000227: is hereby es- tablished in the Treasury an emergency fund designated as the
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p.000227: January 30, 2020
p.000227: 23 Margin of clause (iii) so in law.
p.000227:
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p.000229: PUBLIC HEALTH SERVICE ACT
p.000229: Sec. 319F–4
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p.000229: ‘‘Covered Countermeasure Process Fund’’ for purposes of providing timely, uniform, and adequate compensation to
p.000229: eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure
p.000229: pursuant to such declaration, which Fund shall consist of such amounts designated as emergency ap-
p.000229: propriations under section 402 of H. Con. Res. 95 of the 109th Con- gress, this emergency designation shall remain
p.000229: in effect through October 1, 2006.
p.000229: (b) PAYMENT OF COMPENSATION.—
p.000229: (1) IN GENERAL.—If the Secretary issues a declaration under 319F–3(b), the Secretary shall, after amounts
p.000229: have by law been provided for the Fund under subsection (a), provide compensation to an eligible
p.000229: individual for a covered injury di- rectly caused by the administration or use of a covered coun-
p.000229: termeasure pursuant to such declaration.
p.000229: (2) ELEMENTS OF COMPENSATION.—The compensation that shall be provided pursuant to paragraph (1) shall
p.000229: have the same elements, and be in the same amount, as is prescribed by sections 264, 265, and 266 in the
p.000229: case of certain individuals injured as a result of administration of certain counter- measures against
p.000229: smallpox, except that section 266(a)(2)(B) shall not apply.
p.000229: (3) RULE OF CONSTRUCTION.—Neither reasonable and nec- essary medical benefits nor lifetime total benefits
p.000229: for lost em- ployment income due to permanent and total disability shall be limited by section 266.
p.000229: (4) DETERMINATION OF ELIGIBILITY AND COMPENSATION.— Except as provided in this section, the procedures
p.000229: for deter- mining, and for reviewing a determination of, whether an indi- vidual is an eligible individual,
p.000229: whether such individual has sustained a covered injury, whether compensation may be available under
p.000229: this section, and the amount of such com- pensation shall be those stated in section 262 (other than
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p.000231: award under sub- section (a) that a grantee under such subsection provide non-Fed- eral contributions toward
p.000231: the purpose described in such subsection.
p.000231: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000231: to be appropriated
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p.000231: January 30, 2020
p.000231: 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814).
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: PUBLIC HEALTH SERVICE ACT
p.000233: Sec. 319I
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p.000233: January 30, 2020
p.000233: such sums as may be necessary for each of the fiscal years 2002 through 2006.
p.000233: SEC. 319I. ø247d–7b¿ EMERGENCY SYSTEM FOR ADVANCE REGISTRA- TION OF VOLUNTEER HEALTH PROFESSIONAL.
p.000233: (a) IN GENERAL.—Not later than 12 months after the date of enactment of the Pandemic and All-Hazards
p.000233: Preparedness Act, the Secretary shall link existing State verification systems to maintain a single national
p.000233: interoperable network of systems, each system being maintained by a State or group of States, for the purpose of
p.000233: verifying the credentials and licenses of health care professionals who volunteer to provide health
p.000233: services during a public health emergency. Such health care professionals may include members of the National
p.000233: Disaster Medical System, members of the Medical Re- serve Corps, and individual health care professionals.
p.000233: (b) REQUIREMENTS.—The interoperable network of systems es- tablished under subsection (a) (referred to in
p.000233: this section as the ‘‘verification network’’) shall include—
p.000233: (1) with respect to each volunteer health professional in- cluded in the verification network—
p.000233: (A) information necessary for the rapid identification of, and communication with, such professionals; and
p.000233: (B) the credentials, certifications, licenses, and rel- evant training of such individuals; and
p.000233: (2) the name of each member of the Medical Reserve Corps, the National Disaster Medical System, and any
p.000233: other relevant federally-sponsored or administered programs deter- mined necessary by the Secretary.
p.000233: (c) OTHER ASSISTANCE.—The Secretary may make grants and provide technical assistance to States and other public
p.000233: or nonprofit private entities for activities relating to the verification network de- veloped under subsection (a).
p.000233: (d) ACCESSIBILITY.—The Secretary shall ensure that the verification network is electronically accessible by
p.000233: State, local, and tribal health departments and can be linked with the identification cards under section 2813.
p.000233: (e) CONFIDENTIALITY.—The Secretary shall establish and re- quire the application of and compliance with
p.000233: measures to ensure the effective security of, integrity of, and access to the data in- cluded in the
p.000233: verification network.
p.000233: (f) COORDINATION.—The Secretary shall coordinate with the Secretary of Veterans Affairs and the Secretary of
p.000233: Homeland Secu- rity to assess the feasibility of integrating the verification network under this section with the
p.000233: VetPro system of the Department of Veterans Affairs and the National Emergency Responder
p.000233: Credentialing System of the Department of Homeland Security. The Secretary shall, if feasible, integrate
p.000233: the verification network under this section with such VetPro system and the National Emergency Responder
p.000233: Credentialing System.
p.000233: (g) UPDATING OF INFORMATION.—The States that are partici- pants in the verification network shall, on at
p.000233: least a quarterly basis, work with the Director to provide for the updating of the in- formation contained in the
p.000233: verification network.
p.000233: (h) CLARIFICATION.—Inclusion of a health professional in the verification network shall not constitute
p.000233: appointment of such indi-
p.000233: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: Sec. 319J PUBLIC HEALTH SERVICE ACT 234
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p.000233: January 30, 2020
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p.000233: vidual as a Federal employee for any purpose, either under section 2812(c) or otherwise. Such appointment may
p.000233: only be made under section 2812 or 2813.
p.000233: (i) HEALTH CARE PROVIDER LICENSES.—The Secretary shall en- courage States to establish and implement mechanisms
p.000233: to waive the application of licensing requirements applicable to health pro- fessionals, who are seeking
p.000233: to provide medical services (within their scope of practice), during a national, State, local, or tribal
p.000233: public health emergency upon verification that such health profes- sionals are licensed and in good standing in
p.000233: another State and have not been disciplined by any State health licensing or discipli- nary board. In order to
p.000233: inform the development of such mecha- nisms by States, the Secretary shall make available information and
p.000233: material provided by States that have developed mechanisms to waive the application of licensing
p.000233: requirements to applicable health professionals seeking to provide medical services during a public health
p.000233: emergency. Such information shall be made publicly available in a manner that does not compromise national
p.000233: security.
p.000233: (j) RULE OF CONSTRUCTION.—This section may not be con-
p.000233: strued as authorizing the Secretary to issue requirements regard- ing the provision by the States of
p.000233: credentials, licenses, accredita- tions, or hospital privileges.
p.000233: (k) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000233: to be appropriated
p.000233: $5,000,000 for each of fiscal years 2019 through 2023.
p.000233: SEC. 319J. ø247d–7c¿ SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.
p.000233: (a) IN GENERAL.—Upon the request of a recipient of an award under any of sections 319 through 319I or section
p.000233: 319K, the Sec- retary may, subject to subsection (b), provide supplies, equipment, and services for the
p.000233: purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such
p.000233: purposes, may detail to the recipient any officer or employee of the Depart- ment of Health and Human
p.000233: Services.
p.000233: (b) CORRESPONDING REDUCTION IN PAYMENTS.—With respect to a request described in subsection (a), the Secretary shall
p.000233: reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the
p.000233: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for
p.000233: the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.000233: SEC. 319K. ø247d–7d¿ SECURITY FOR COUNTERMEASURE DEVELOP- MENT AND PRODUCTION.
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p.000253: (d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of
p.000253: deceased patients; and
p.000253: (e) Provide, to the extent the Surgeon General determines that other public or private funds are not available
p.000253: therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable
p.000253: burial expenses for, any patient dying in a hospital or station.
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p.000253: January 30, 2020
p.000253:
p.000253: CARE AND TREATMENT OF PERSONS UNDER QUARANTINE AND CERTAIN OTHER PERSONS
p.000253: SEC. 322. ø249¿ (a) Any person when detained in accordance with quarantine laws, or, at the request of
p.000253: the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for
p.000253: by the Public Health Service.
p.000253: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000255: PUBLIC HEALTH SERVICE ACT
p.000255: Sec. 324
p.000255:
p.000255: (b) Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in
p.000255: accordance with regu- lations of the Surgeon General, be admitted thereto for temporary treatment and care in
p.000255: case of emergency.
p.000255: (c) Persons whose care and treatment is authorized by sub- section (a) may, in accordance with
p.000255: regulations, receive such care and treatment at the expense of the Service from public or private medical or
p.000255: hospital facilities other than those of the Service, when authorized by the officer in charge of the station
p.000255: at which the ap- plication is made.
p.000255: CARE AND TREATMENT OF FEDERAL PRISONERS 27
p.000255: SEC. 323. ø250¿ The Service shall supervise and furnish med- ical treatment and other necessary medical,
p.000255: psychiatric, and re- lated technical and scientific services, authorized by the Act of May 13, 1930, as amended
p.000255: (U.S.C., 1940 edition, title 18, secs. 751, 752), 28 in penal and correctional institutions of the United
p.000255: States.
p.000255: EXAMINATION AND TREATMENT OF FEDERAL EMPLOYEES
p.000255: SEC. 324. ø251¿ (a) The Surgeon General is authorized to pro- vide at institutions, hospitals, and stations of
p.000255: the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under
p.000255: the United States Employees’ Compensation Act 29 and extensions thereof. The Surgeon General may also provide
p.000255: for making medical examinations of—
p.000255: (1) employees of the Federal Government for retirement purposes;
p.000255: (2) employees in Federal classified service, and applicants for appointment, as requested by the Civil Service
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p.000257: (2) LIMITATION.—The requirement in paragraph (1) to pro- vide services for all residents within a catchment
p.000257: area shall not apply in the case of a health center receiving a grant only under subsection (g), (h), or (i).
p.000257: (b) DEFINITIONS.—For purposes of this section:
p.000257: (1) REQUIRED PRIMARY HEALTH SERVICES.—
p.000257: (A) IN GENERAL.—The term ‘‘required primary health services’’ means—
p.000257: (i) basic health services which, for purposes of this section, shall consist of—
p.000257: (I) health services related to family medicine, internal medicine, pediatrics, obstetrics, or gyne- cology
p.000257: that are furnished by physicians and where appropriate, physician assistants, nurse practi- tioners, and nurse
p.000257: midwives;
p.000257: (II) diagnostic laboratory and radiologic serv- ices;
p.000257: (III) preventive health services, including— (aa) prenatal and perinatal services; (bb) appropriate cancer screening;
p.000257: (cc) well-child services;
p.000257: (dd) immunizations against vaccine-pre- ventable diseases;
p.000257: (ee) screenings for elevated blood lead lev- els, communicable diseases, and cholesterol;
p.000257: (ff) pediatric eye, ear, and dental screenings to determine the need for vision and hearing
p.000257: correction and dental care;
p.000257: (gg) voluntary family planning services;
p.000257: and
p.000257: (hh) preventive dental services;
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p.000257: (IV) emergency medical services; and
p.000257: (V) pharmaceutical services as may be appro- priate for particular centers;
p.000257: (ii) referrals to providers of medical services (in- cluding specialty referral when medically indicated)
p.000257: and other health-related services (including substance use disorder and mental health services);
p.000257: (iii) patient case management services (including counseling, referral, and follow-up services) and other
p.000257: services designed to assist health center patients in
p.000257: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000259: PUBLIC HEALTH SERVICE ACT
p.000259: Sec. 330
p.000259:
p.000259: establishing eligibility for and gaining access to Fed- eral, State, and local programs that provide or
p.000259: finan- cially support the provision of medical, social, housing, educational, or other related services;
p.000259: (iv) services that enable individuals to use the services of the health center (including outreach and
p.000259: transportation services and, if a substantial number of the individuals in the population served by a center
p.000259: are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a
p.000259: predominant number of such individuals); and
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p.000269: application for a grant under subparagraph (A) or (B) of sub- section (e)(1), the Secretary may require
p.000269: as a condition to the approval of such application an assurance that the applicant will provide any
p.000269: health service defined under paragraphs (1) and (2) of subsection (b) that the Secretary finds is needed
p.000269: to meet specific health needs of the area to be served by the ap- plicant. Such a finding shall be
p.000269: made in writing and a copy shall be provided to the applicant.
p.000269: (3) REQUIREMENTS.—Except as provided in subsection
p.000269: (e)(1)(B) or subsection (e)(6), the Secretary may not approve an application for a grant under subparagraph (A)
p.000269: or (B) of sub- section (e)(1) unless the Secretary determines that the entity for which the application is
p.000269: submitted is a health center (with- in the meaning of subsection (a)) and that—
p.000269: (A) the required primary health services of the center will be available and accessible in the catchment area
p.000269: of the center promptly, as appropriate, and in a manner which assures continuity;
p.000269: (B) the center has made and will continue to make every reasonable effort to establish and maintain
p.000269: collabo- rative relationships with other health care providers, in- cluding other health care providers that
p.000269: provide care with- in the catchment area, local hospitals, and specialty pro- viders in the catchment area
p.000269: of the center, to provide ac- cess to services not available through the health center and to reduce
p.000269: the non-urgent use of hospital emergency departments;
p.000269: (C) the center will have an ongoing quality improve- ment system that includes clinical services and
p.000269: manage- ment, and that maintains the confidentiality of patient records;
p.000269: (D) the center will demonstrate its financial responsi- bility by the use of such accounting procedures
p.000269: and other requirements as may be prescribed by the Secretary;
p.000269: (E) the center—
p.000269: (i)(I) has or will have a contractual or other ar- rangement with the agency of the State, in which
p.000269: it provides services, which administers or supervises the administration of a State plan approved under title
p.000269: XIX of the Social Security Act for the payment of all or a part of the center’s costs in providing health
p.000269: serv- ices to persons who are eligible for medical assistance under such a State plan; and
p.000269: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000269:
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p.000269: Sec. 330 PUBLIC HEALTH SERVICE ACT 270
p.000269:
p.000269: (II) 32 has or will have a contractual or other arrangement with the State agency administering the program
p.000269: under title XXI of such Act (42
p.000269: U.S.C. 1397aa et seq.) with respect to individuals who are State children’s health insurance program
p.000269: beneficiaries; or
p.000269: (ii) has made or will make every reasonable effort to enter into arrangements described in subclauses (I) and (II) of
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p.000291:
p.000291: (ii) NATURE OF ENTITIES.—Each entity partici- pating in the telehealth network may be a nonprofit or
p.000291: for-profit entity.
p.000291: (iii) COMPOSITION OF NETWORK.—The telehealth network shall include at least 2 of the following enti- ties
p.000291: (at least 1 of which shall be a community-based health care provider):
p.000291: (I) Community or migrant health centers or other Federally qualified health centers.
p.000291: (II) Health care providers, including phar- macists, in private practice.
p.000291: (III) Entities operating clinics, including rural health clinics.
p.000291: (IV) Local health departments.
p.000291: (V) Nonprofit hospitals, including community access hospitals.
p.000291: (VI) Other publicly funded health or social service agencies.
p.000291: (VII) Long-term care providers.
p.000291: (VIII) Providers of health care services in the home.
p.000291: (IX) Providers of outpatient mental health services and entities operating outpatient mental health
p.000291: facilities.
p.000291: (X) Local or regional emergency health care providers.
p.000291: (XI) Institutions of higher education.
p.000291: (XII) Entities operating dental clinics.
p.000291: (2) TELEHEALTH RESOURCE CENTERS GRANTS.—To be eligi- ble to receive a grant under subsection (d)(2), an
p.000291: entity shall be a nonprofit entity.
p.000291: (g) APPLICATIONS.—To be eligible to receive a grant under sub- section (d), an eligible entity, in consultation
p.000291: with the appropriate State office of rural health or another appropriate State entity, shall prepare and
p.000291: submit to the Secretary an application, at such time, in such manner, and containing such information as the
p.000291: Sec- retary may require, including—
p.000291: (1) a description of the project that the eligible entity will carry out using the funds provided under the grant;
p.000291: (2) a description of the manner in which the project funded under the grant will meet the health care needs of
p.000291: rural or other populations to be served through the project, or improve the access to services of, and the
p.000291: quality of the services re- ceived by, those populations;
p.000291: (3) evidence of local support for the project, and a descrip- tion of how the areas, communities, or populations to be
p.000291: served will be involved in the development and ongoing operations of the project;
p.000291: (4) a plan for sustaining the project after Federal support for the project has ended;
p.000291: (5) information on the source and amount of non-Federal funds that the entity will provide for the project;
p.000291: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000291:
p.000291:
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p.000295: committees of Con- gress a report on the progress and accomplishments of the grant programs described in
p.000295: subsection (b).
p.000295: (r) REGULATIONS.—The Secretary shall issue regulations speci- fying, for purposes of this section, a definition of the
p.000295: term ‘‘frontier area’’. The definition shall be based on factors that include popu- lation density, travel
p.000295: distance in miles to the nearest medical facil- ity, travel time in minutes to the nearest medical facility, and such
p.000295: other factors as the Secretary determines to be appropriate. The Secretary shall develop the definition
p.000295: in consultation with the Di-
p.000295: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000297: PUBLIC HEALTH SERVICE ACT
p.000297: Sec. 330J
p.000297:
p.000297: rector of the Bureau of the Census and the Administrator of the Economic Research Service of the Department
p.000297: of Agriculture.
p.000297: (s) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section—
p.000297: (1) for grants under subsection (d)(1), $40,000,000 for fiscal year 2002, and such sums as may be necessary for each of
p.000297: fis- cal years 2003 through 2006; and
p.000297: (2) for grants under subsection (d)(2), $20,000,000 for fiscal year 2002, and such sums as may be necessary for each of
p.000297: fis- cal years 2003 through 2006.
p.000297: SEC. 330J. ø254c–15¿ RURAL EMERGENCY MEDICAL SERVICE TRAINING AND EQUIPMENT ASSISTANCE PROGRAM.
p.000297: (a) GRANTS.—The Secretary, acting through the Administrator of the Health Resources and Services Administration
p.000297: (referred to in this section as the ‘‘Secretary’’) shall award grants to eligible enti- ties to enable such entities to
p.000297: provide for improved emergency med- ical services in rural areas or to residents of rural areas.
p.000297: (b) ELIGIBILITY; APPLICATION.—To be eligible to receive grant under this section, an entity shall—
p.000297: (1) be—
p.000297: (A) an emergency medical services agency operated by a local or tribal government (including fire-based and non- fire
p.000297: based); or
p.000297: (B) an emergency medical services agency that is de- scribed in section 501(c) of the Internal Revenue
p.000297: Code of 1986 and exempt from tax under section 501(a) of such Code; and
p.000297: (2) submit an application to the Secretary at such time, in such manner, and containing such information as the
p.000297: Sec- retary may require.
p.000297: (c) USE OF FUNDS.—An entity—
p.000297: (1) shall use amounts received through a grant under sub- section (a) to—
p.000297: (A) train emergency medical services personnel as ap- propriate to obtain and maintain licenses and certifications
p.000297: relevant to service in an emergency medical services agen- cy described in subsection (b)(1);
p.000297: (B) conduct courses that qualify graduates to serve in an emergency medical services agency described in
p.000297: sub- section (b)(1) in accordance with State and local require- ments;
p.000297: (C) fund specific training to meet Federal or State li- censing or certification requirements; and
p.000297: (D) acquire emergency medical services equipment;
p.000297:
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p.000297: January 30, 2020
p.000297: and
p.000297: (2) may use amounts received through a grant under sub- section (a) to—
p.000297: (A) recruit and retain emergency medical services per- sonnel, which may include volunteer personnel;
p.000297: (B) develop new ways to educate emergency health care providers through the use of
p.000297: technology-enhanced educational methods; or
p.000297: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000297: Sec. 330K PUBLIC HEALTH SERVICE ACT 298
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p.000297: (C) acquire personal protective equipment for emer- gency medical services personnel as required by the Occu-
p.000297: pational Safety and Health Administration.
p.000297: (d) GRANT AMOUNTS.—Each grant awarded under this section shall be in an amount not to exceed $200,000.
p.000297: (e) DEFINITIONS.—In this section:
p.000297: (1) The term ‘‘emergency medical services’’—
p.000297: (A) means resources used by a public or private non- profit licensed entity to deliver medical care
p.000297: outside of a medical facility under emergency conditions that occur as a result of the condition of the
p.000297: patient; and
p.000297: (B) includes services delivered (either on a com- pensated or volunteer basis) by an emergency
p.000297: medical services provider or other provider that is licensed or cer- tified by the State involved as an
p.000297: emergency medical tech- nician, a paramedic, or an equivalent professional (as de- termined by the State).
p.000297: (2) The term ‘‘rural area’’ means—
p.000297: (A) a nonmetropolitan statistical area;
p.000297: (B) an area designated as a rural area by any law or regulation of a State; or
p.000297: (C) a rural census tract of a metropolitan statistical area (as determined under the most recent rural
p.000297: urban commuting area code as set forth by the Office of Manage- ment and Budget).
p.000297: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section to an entity unless the entity agrees
p.000297: that the entity will make available (directly or through contributions from other public or private entities)
p.000297: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of
p.000297: the amount received under the grant.
p.000297: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000297: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section such sums as may be
p.000297: necessary for each of fiscal years 2019 through 2023.
p.000297: (2) ADMINISTRATIVE COSTS.—The Secretary may use not more than 10 percent of the amount appropriated under para-
p.000297: graph (1) for a fiscal year for the administrative expenses of carrying out this section.
p.000297: SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
p.000297: (a) DEFINITIONS.—In this section:
p.000297: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider
p.000297: network that of- fers services that include mental health services provided by qualified mental health
p.000297: providers.
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p.000343: health departments that serve health professional shortage areas or other areas at risk of a public
p.000343: health emer- gency, as designated by the Secretary.
p.000343: (2) LOANS ELIGIBLE FOR REPAYMENT.—To be eligible for re- payment under this subsection, a loan shall be a
p.000343: loan made, insured, or guaranteed by the Federal Government that is bor- rowed by, or on behalf of, an
p.000343: individual to pay the cost of at- tendance for a program of education leading to a degree appro- priate for
p.000343: serving in a State, local, or tribal health department as determined by the Secretary and the chief executive
p.000343: officer of the State in which the grant is administered, at an institu- tion of higher education (as defined in section
p.000343: 102 of the High- er Education Act of 1965), including principal, interest, and re- lated expenses on such loan.
p.000343: (3) APPLICABILITY OF EXISTING REQUIREMENTS.—With re- spect to awards made under paragraph (1)—
p.000343: (A) the requirements of subsections (b), (f), and (g) shall apply to such awards; and
p.000343: (B) the requirements of subsection (c) shall apply to such awards except that with respect to paragraph
p.000343: (1) of such subsection, the State involved may assign an indi- vidual only to public and nonprofit
p.000343: private entities that serve health professional shortage areas or areas at risk of a public health emergency, as
p.000343: determined by the Sec- retary.
p.000343: (4) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection, such
p.000343: sums as may be necessary for each of fiscal years 2007 through 2010.
p.000343: SEC. 338J. ø254r¿ GRANTS TO STATE OFFICES OF RURAL HEALTH.
p.000343: (a) IN GENERAL.—The Secretary, acting through the Director of the Federal Office of Rural Health Policy (established
p.000343: under section 711 of the Social Security Act), shall make grants to each State Of- fice of Rural Health for the
p.000343: purpose of improving health care in rural areas.
p.000343: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000343: (1) IN GENERAL.—Subject to paragraph (2), the Secretary may not make a grant under subsection (a) unless the
p.000343: State of- fice of rural health involved agrees, with respect to the costs
p.000343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000343:
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p.000343: Sec. 338J PUBLIC HEALTH SERVICE ACT 344
p.000343:
p.000343: to be incurred in carrying out the purpose described in such subsection, to provide non-Federal
p.000343: contributions toward such costs in an amount equal to $3 for each $1 of Federal funds provided in the
p.000343: grant.
p.000343: (2) WAIVER OR REDUCTION.—The Secretary may waive or reduce the non-Federal contribution if the Secretary
p.000343: deter- mines that requiring matching funds would limit the State of- fice of rural health’s ability to carry out the
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p.000347: appears in full figures. However, the version represented here in the pdf reflects this
p.000347: Continued
p.000347: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000347:
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p.000347: Sec. 338M PUBLIC HEALTH SERVICE ACT 348
p.000347:
p.000347: that the number of individuals participating in the demonstra- tion project established under this section is
p.000347: insufficient for purposes of performing the evaluation described in subsection (f)(1), the authorization of
p.000347: appropriations under paragraph (1) shall be extended to include fiscal year 2005.
p.000347: SEC. 338M. ø254u¿ PUBLIC HEALTH DEPARTMENTS.
p.000347: (a) IN GENERAL.—To the extent that funds are appropriated under subsection (e), the Secretary shall establish a
p.000347: demonstration project to provide for the participation of individuals who are eligi- ble for the Loan Repayment Program
p.000347: described in section 338B and who agree to complete their service obligation in a State health de- partment that
p.000347: provides a significant amount of service to health professional shortage areas or areas at risk of a public
p.000347: health emer- gency, as determined by the Secretary, or in a local or tribal health department that serves a health
p.000347: professional shortage area or an area at risk of a public health emergency.
p.000347: (b) PROCEDURE.—To be eligible to receive assistance under sub- section (a), with respect to the program described in
p.000347: section 338B, an individual shall—
p.000347: (1) comply with all rules and requirements described in such section (other than section 338B(f)(1)(B)(iv));
p.000347: and
p.000347: (2) agree to serve for a time period equal to 2 years, or such longer period as the individual may
p.000347: agree to, in a State, local, or tribal health department, described in subsection (a).
p.000347: (c) DESIGNATIONS.—The demonstration project described in subsection (a), and any healthcare providers
p.000347: who are selected to participate in such project, shall not be considered by the Secretary in the designation of
p.000347: health professional shortage areas under sec- tion 332 during fiscal years 2007 through 2010.
p.000347: (d) REPORT.—Not later than 3 years after the date of enact- ment of this section, the Secretary shall submit
p.000347: a report to the rel- evant committees of Congress that evaluates the participation of individuals in the
p.000347: demonstration project under subsection (a), the impact of such participation on State, local, and tribal
p.000347: health de- partments, and the benefit and feasibility of permanently allowing such placements in the Loan Repayment
p.000347: Program.
p.000347: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, such
p.000347: sums as may be necessary for each of fiscal years 2007 through 2010.
p.000347: SEC. 338N. ø254v¿ CLARIFICATION REGARDING SERVICE IN SCHOOLS AND OTHER COMMUNITY-BASED SETTINGS.
p.000347: (a) SCHOOLS AND COMMUNITY-BASED SETTINGS.—An entity to which a participant in the Scholarship Program or the
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p.000377: January 30, 2020
p.000377:
p.000377: (A) the expansion or establishment of a community- based dental facility, free-standing dental clinic,
p.000377: consoli- dated health center dental facility, school-linked dental fa- cility, or United States dental school-based
p.000377: facility;
p.000377: (B) the establishment of a mobile or portable dental clinic;
p.000377: (C) the establishment or expansion of private dental services to enhance capacity through additional equipment
p.000377: or additional hours of operation;
p.000377: (D) the establishment or development of models for the provision of dental services to children and
p.000377: adults, such as dental homes, including for the elderly, blind, indi- viduals with disabilities, and individuals
p.000377: living in long- term care facilities; and
p.000377: (E) the establishment of initiatives to reduce the use of emergency departments by individuals who seek
p.000377: dental services more appropriately delivered in a dental primary care setting;
p.000377: (6) placement and support of dental students, dental resi- dents, and advanced dentistry trainees;
p.000377: (7) continuing dental education, including distance-based education;
p.000377: (8) practice support through teledentistry conducted in ac- cordance with State laws;
p.000377: (9) community-based prevention services such as water fluoridation and dental sealant programs;
p.000377: (10) coordination with local educational agencies within the State to foster programs that promote
p.000377: children going into oral health or science professions;
p.000377: (11) the establishment of faculty recruitment programs at accredited dental training institutions whose
p.000377: mission includes community outreach and service and that have a demonstrated record of serving underserved States;
p.000377: (12) the development of a State dental officer position or the augmentation of a State dental office to
p.000377: coordinate oral health and access issues in the State; and
p.000377: (13) any other activities determined to be appropriate by the Secretary.
p.000377: (c) APPLICATION.—
p.000377: (1) IN GENERAL.—Each State desiring a grant under this section shall submit an application to the
p.000377: Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.
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p.000407: Sec. 351A PUBLIC HEALTH SERVICE ACT 408
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p.000407: January 30, 2020
p.000407:
p.000407: on which both of the following conditions have been met by the person requesting the exemption:
p.000407: (I) The person has submitted to the Secretary an application for the exemption meeting the re- quirements
p.000407: established by the Secretary.
p.000407: (II) The person has notified the Secretary that the investigation has been authorized under such an Act.
p.000407: (3) PUBLIC HEALTH EMERGENCIES.—The Secretary may temporarily exempt a person from the applicability
p.000407: of the re- quirements of this section, in whole or in part, if the Secretary determines that such exemption is
p.000407: necessary to provide for the timely participation of the person in a response to a domestic or foreign public
p.000407: health emergency (whether determined under section 319(a) or otherwise) that involves a listed agent or toxin.
p.000407: With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary,
p.000407: after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.
p.000407: (4) AGRICULTURAL EMERGENCIES.—Upon request of the Secretary of Agriculture, after the granting by
p.000407: such Secretary of an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of
p.000407: 2002 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human
p.000407: Services may temporarily exempt a person from the applicability of the requirements of this section, in
p.000407: whole or in part, to provide for the timely participation of the person in a response to the agricultural
p.000407: emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not
p.000407: exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human
p.000407: Services may, after review of whether such exemption remains necessary, provide one extension of an additional
p.000407: 30 days.
p.000407: (h) DISCLOSURE OF INFORMATION.—
p.000407: (1) NONDISCLOSURE OF CERTAIN INFORMATION.—No Federal agency specified in paragraph (2) shall disclose under
p.000407: section 552 of title 5, United States Code, any of the following:
p.000407: (A) Any registration or transfer documentation sub- mitted under subsections (b) and (c) for the
p.000407: possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that
p.000407: it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses
p.000407: the identity or location of a specific registered person.
p.000407: (B) The national database developed pursuant to sub- section (d), or any other compilation of the
p.000407: registration or transfer information submitted under subsections (b) and
p.000407: (c) to the extent that such compilation discloses site-spe- cific registration or transfer information.
p.000407: (C) Any portion of a record that discloses the site-spe- cific or transfer-specific safeguard and security
p.000407: measures used by a registered person to prevent unauthorized access to listed agents and toxins.
p.000407: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000441: 441
p.000441: PUBLIC HEALTH SERVICE ACT
p.000441: Sec. 363
p.000441:
p.000441: applicable only to individuals coming into a State or possession from a foreign country or a possession.
p.000441: (d)(1) Regulations prescribed under this section may provide for the apprehension and examination of any
p.000441: individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be
p.000441: moving or about to move from a State to an- other State; or (B) to be a probable source of infection
p.000441: to individ- uals who, while infected with such disease in a qualifying stage, will be moving from a State
p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
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p.000447: 447
p.000447: PUBLIC HEALTH SERVICE ACT
p.000447: Sec. 371
p.000447:
p.000447: (II) rely on outcome and process performance measures that are based on empirical evidence, ob-
p.000447: tained through reasonable efforts, of organ donor po- tential and other related factors in each service
p.000447: area of qualified organ procurement organizations;
p.000447: (III) use multiple outcome measures as part of the certification process; and
p.000447: (IV) provide for a qualified organ procurement or- ganization to appeal a decertification to the Secretary on
p.000447: substantive and procedural grounds;
p.000447: (E) has procedures to obtain payment for non-renal organs provided to transplant centers,
p.000447: (F) has a defined service area that is of sufficient size to assure maximum effectiveness in the
p.000447: procurement and equi- table distribution of organs, and that either includes an entire metropolitan statistical area
p.000447: (as specified by the Director of the Office of Management and Budget) or does not include any part of the
p.000447: area,
p.000447: (G) has a director and such other staff, including the organ donation coordinators and organ procurement
p.000447: specialists nec- essary to effectively obtain organs from donors in its service area, and
p.000447: (H) has a board of directors or an advisory board which—
p.000447: (i) is composed of—
p.000447: (I) members who represent hospital administra- tors, intensive care or emergency room personnel, tis- sue
p.000447: banks, and voluntary health associations in its service area,
p.000447: (II) members who represent the public residing in such area,
p.000447: (III) a physician with knowledge, experience, or skill in the field of histocompatability 78 or an indi-
p.000447: vidual with a doctorate degree in a biological science with knowledge, experience, or skill in the field
p.000447: of histocompatibility,
p.000447: (IV) a physician with knowledge or skill in the field of neurology, and
p.000447: (V) from each transplant center in its service area which has arrangements described in paragraph (3)(G) with the
p.000447: organization, a member who is a surgeon who has practicing privileges in such center and who per- forms organ
p.000447: transplant surgery,
p.000447: (ii) has the authority to recommend policies for the procurement of organs and the other functions described in
p.000447: paragraph (3), and
p.000447: (iii) has no authority over any other activity of the or- ganization.
p.000447: (2)(A) Not later than 90 days after the date of the enactment of this paragraph, 80 the Secretary shall
p.000447: publish in the Federal Reg- ister a notice of proposed rulemaking to establish criteria for deter-
p.000447:
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p.000447: January 30, 2020
p.000447: 78 So in law. Probably should be ‘‘histocompatibility’’.
p.000447: 79 So in law. Probably should be paragraph (3).
p.000447: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000471: January 30, 2020
p.000471:
p.000471: orders or other related topics the Director determines appro- priate.
p.000471: (b) ENHANCED CONTROLLED SUBSTANCE OVERDOSE DATA COL-
p.000471: LECTION, ANALYSIS, AND DISSEMINATION GRANTS.—
p.000471: (1) IN GENERAL.—The Director of the Centers for Disease Control and Prevention may—
p.000471: (A) to the extent practicable, carry out any controlled substance overdose data collection activities
p.000471: described in paragraph (2);
p.000471: (B) provide training and technical assistance to States, localities, and Indian tribes for purposes of carrying
p.000471: out such activity;
p.000471: (C) award grants to States, localities, and Indian tribes for purposes of carrying out such activity; and
p.000471: (D) coordinate with the Assistant Secretary for Mental Health and Substance Use to collect data pursuant to sec- tion
p.000471: 505(d)(1)(A) (relating to the number of individuals ad- mitted to emergency departments as a result of the abuse of
p.000471: alcohol or other drugs).
p.000471: (2) CONTROLLED SUBSTANCE OVERDOSE DATA COLLECTION AND ANALYSIS ACTIVITIES.—A controlled substance
p.000471: overdose data collection, analysis, and dissemination activity described in this paragraph is any of the
p.000471: following activities:
p.000471: (A) Improving the timeliness of reporting data to the public, including data on fatal and nonfatal
p.000471: overdoses of controlled substances.
p.000471: (B) Enhancing the comprehensiveness of controlled substance overdose data by collecting information on
p.000471: such overdoses from appropriate sources such as toxicology re- ports, autopsy reports, death scene
p.000471: investigations, and emergency departments.
p.000471: (C) Modernizing the system for coding causes of death related to controlled substance overdoses to use an elec-
p.000471: tronic-based system.
p.000471: (D) Using data to help identify risk factors associated with controlled substance overdoses.
p.000471: (E) Supporting entities involved in providing informa- tion on controlled substance overdoses, such as
p.000471: coroners, medical examiners, and public health laboratories to im- prove accurate testing and
p.000471: standardized reporting of causes and contributing factors to controlled substances overdoses and analysis of
p.000471: various opioid analogues to con- trolled substance overdoses.
p.000471: (F) Working to enable and encourage the access, ex- change, and use of information regarding controlled
p.000471: sub- stance overdoses among data sources and entities.
p.000471: (c) DEFINITIONS.—In this section:
p.000471: (1) CONTROLLED SUBSTANCE.—The term ‘‘controlled sub- stance’’ has the meaning given that term in section 102 of
p.000471: the Controlled Substances Act.
p.000471: (2) INDIAN TRIBE.—The term ‘‘Indian tribe’’ has the mean- ing given that term in section 4 of the Indian
p.000471: Self-Determina- tion and Education Assistance Act.
p.000471: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000471:
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p.000475: section for each fiscal year for administrative expenses.
p.000475:
p.000475: PREVENTION OF TRAUMATIC BRAIN INJURY
p.000475: SEC. 393B. ø280b–1c¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000475: Control and Pre- vention, may carry out projects to reduce the incidence of traumatic brain injury. Such projects
p.000475: may be carried out by the Secretary di- rectly or through awards of grants or contracts to public or non-
p.000475: profit private entities. The Secretary may directly or through such awards provide technical assistance with
p.000475: respect to the planning, development, and operation of such projects.
p.000475: (b) CERTAIN ACTIVITIES.—Activities under subsection (a) may include—
p.000475: (1) the conduct of research into identifying effective strate- gies for the prevention of traumatic brain injury;
p.000475: (2) the implementation of public information and education programs for the prevention of such injury and for
p.000475: broadening the awareness of the public concerning the public health con- sequences of such injury; and
p.000475: (3) the implementation of a national education and aware- ness campaign regarding such injury (in conjunction
p.000475: with the program of the Secretary regarding health-status goals for 2020, commonly referred to as Healthy
p.000475: People 2020), includ- ing—
p.000475: (A) the national dissemination of information on—
p.000475: (i) incidence and prevalence; and
p.000475: (ii) information relating to traumatic brain injury and the sequelae of secondary conditions arising from
p.000475: traumatic brain injury upon discharge from hospitals and emergency departments; and
p.000475: (B) the provision of information in primary care set- tings, including emergency rooms and trauma centers, con-
p.000475: cerning the availability of State level services and re- sources.
p.000475: (c) COORDINATION OF ACTIVITIES.—The Secretary shall ensure that activities under this section are
p.000475: coordinated as appropriate with other agencies of the Public Health Service that carry out ac- tivities regarding
p.000475: traumatic brain injury.
p.000475: (d) DEFINITION.—For purposes of this section, the term ‘‘trau- matic brain injury’’ means an acquired
p.000475: injury to the brain. Such term does not include brain dysfunction caused by congenital or de- generative disorders,
p.000475: nor birth trauma, but may include brain inju- ries caused by anoxia due to trauma. The Secretary may revise the
p.000475: definition of such term as the Secretary determines necessary, after consultation with States and other
p.000475: appropriate public or nonprofit private entities.
p.000475:
p.000475:
p.000475:
p.000475: January 30, 2020 As Amended Through P.L. 116-94,
p.000475: Enacted December 20, 2019
p.000475:
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p.000475: Sec. 393C PUBLIC HEALTH SERVICE ACT 476
p.000475:
p.000475: NATIONAL PROGRAM FOR TRAUMATIC BRAIN INJURY SURVEILLANCE AND REGISTRIES
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p.000491: January 30, 2020
p.000491: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.000491: (m) REPORTS TO SECRETARY.—To be eligible to receive a grant under this section, an entity must agree to submit
p.000491: an annual re- port on the services provided under this section to the Secretary in such manner and containing
p.000491: such information as the Secretary by regulation requires. At a minimum, the entity shall report informa- tion
p.000491: concerning eligible families, including—
p.000491: (1) the characteristics of the families and children receiv- ing services under this section;
p.000491: (2) the usage, nature, and location of the provider, of pre- ventive health services, including prenatal,
p.000491: primary infant, and child health care;
p.000491: (3) the incidence of low birthweight and premature infants;
p.000491: (4) the length of hospital stays for pre- and post-partum women and their children;
p.000491: (5) the incidence of substantiated child abuse and neglect for all children within participating families;
p.000491: (6) the number of emergency room visits for routine health care;
p.000491: (7) the source of payment for health care services and the extent to which the utilization of health care
p.000491: services, other than routine screening and medical care, available to the indi- viduals under the program
p.000491: established under title XIX of the Social Security Act, and under other Federal, State, and local
p.000491: programs, is reduced;
p.000491: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000491:
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p.000491: Sec. 399 PUBLIC HEALTH SERVICE ACT 492
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p.000491: January 30, 2020
p.000491:
p.000491: (8) the number and type of referrals made for health and related social services, including alcohol and
p.000491: drug treatment services, and the utilization of such services provided by the grantee; and
p.000491: (9) the incidence of developmental disabilities.
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p.000497: the successful or unsuccessful termination of treatment;
p.000497: (5) information concerning the costs of the services pro- vided and the source of financing for health care
p.000497: services;
p.000497: (6) information concerning—
p.000497: (A) the number and characteristics of families, par- ents, and children served, including a description
p.000497: of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
p.000497: (B) the number of children served who remained with their parents during the period in which entities provided services
p.000497: under this section;
p.000497: (C) the number of children served who were placed in out-of-home care during the period in which entities pro-
p.000497: vided services under this section;
p.000497: (D) the number of children described in subparagraph
p.000497: (C) who were reunited with their families; and
p.000497: (E) the number of children described in subparagraph
p.000497: (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family
p.000497: reunifica- tion;
p.000497: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000497: (8) such other information as the Secretary determines to be appropriate.
p.000497: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000497: (1) an application for the grant is submitted to the Sec- retary;
p.000497: (2) the application contains the agreements required in this section and the information required in subsection
p.000497: (h); and
p.000497: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000497: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000497: (k) PEER REVIEW.—
p.000497: (1) REQUIREMENT.—In making determinations for award- ing grants under subsection (a), the Secretary shall rely on
p.000497: the recommendations of the peer review panel established under paragraph (2).
p.000497: (2) COMPOSITION.—The Secretary shall establish a review panel to make recommendations under paragraph
p.000497: (1) that shall be composed of—
p.000497: (A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
p.000497: (B) representatives of relevant Federal agencies, in- cluding the Health Resources and Services Administration,
p.000497: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000497:
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p.000505: abuse and sustain participation in treatment over time until the pro- vider and the individual receiving
p.000505: treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful
p.000505: or unsuccessful termination of treatment;
p.000505: (5) information concerning the costs of the services provided and the source of financing for health care services;
p.000505: (6) information concerning—
p.000505: (A) the number and characteristics of families, parents, and children served, including a description of the type and
p.000505: severity of childhood disabilities, and an analysis of the number of children served by age;
p.000505: (B) the number of children served who remained with their parents during the period in which entities
p.000505: provided services under this section; and
p.000505: (C) the number of case workers or other professionals trained to identify and address substance abuse issues.
p.000505: (7) information on hospitalization or emergency room use by the family members participating in the program; and
p.000505: (8) such other information as the Secretary determines to be appropriate.
p.000505: (j) REQUIREMENT OF APPLICATION.—The Secretary may make any grant under subsection (a) only if—
p.000505:
p.000505:
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p.000505: January 30, 2020
p.000505: 95 The lack of a comma would be so in law. See section 3106(e)(1)(A) of Public Law 106–310 (114 Stat.
p.000505: 1177).
p.000505: 96 The superfluous semicolon would be so in law. See section 3106(e)(1)(C) of Public Law 106– 310 (114 Stat. 1177).
p.000505: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000505: Sec. 399A PUBLIC HEALTH SERVICE ACT 506
p.000505:
p.000505: (1) an application for the grant is submitted to the Sec- retary;
p.000505: (2) the application contains the agreements required in this section and the information required in subsection (h);
p.000505: and
p.000505: (3) the application is in such form, is made in such man- ner, and contains such agreements,
p.000505: assurances, and informa- tion as the Secretary determines to be necessary to carry out this section.
p.000505: (k) EVALUATIONS.—The Secretary shall periodically conduct evaluations to determine the effectiveness of
p.000505: programs supported under subsection (a)—
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p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
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p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000525: 525
p.000525: PUBLIC HEALTH SERVICE ACT
p.000525: Sec. 399L
p.000525:
p.000525: (A) Projects to provide comprehensive asthma services to children in accordance with the guidelines of the Na-
p.000525: tional Asthma Education and Prevention Program (through the National Heart, Lung and Blood
p.000525: Institute), including access to care and treatment for asthma in a community-based setting.
p.000525: (B) Projects to fully equip mobile health care clinics that provide preventive asthma care including
p.000525: diagnosis, physical examinations, pharmacological therapy, skin test- ing, peak flow meter testing, and other
p.000525: asthma-related health care services.
p.000525: (C) Projects to conduct validated asthma management education programs for patients with asthma and their
p.000525: families, including patient education regarding asthma management, family education on asthma
p.000525: management, and the distribution of materials, including displays and videos, to reinforce concepts
p.000525: presented by medical teams.
p.000525: (2) 103 AWARD OF GRANTS.—
p.000525: (A) APPLICATION.—
p.000525: (i) IN GENERAL.—An eligible entity shall submit an application to the Secretary for a grant under this
p.000525: section in such form and manner as the Secretary may require.
p.000525: (ii) REQUIRED INFORMATION.—An application sub- mitted under this subparagraph shall include a plan for the
p.000525: use of funds awarded under the grant and such other information as the Secretary may require.
p.000525: (B) REQUIREMENT.—In awarding grants under this section, the Secretary shall give preference to eligible enti-
p.000525: ties that demonstrate that the activities to be carried out under this section shall be in localities
p.000525: within areas of known or suspected high prevalence of childhood asthma or high asthma-related mortality
p.000525: or high rate of hos- pitalization or emergency room visits for asthma (relative to the average
p.000525: asthma prevalence rates and associated mortality rates in the United States). Acceptable data sets to demonstrate
p.000525: a high prevalence of childhood asthma or high asthma-related mortality may include data from Fed- eral, State, or
p.000525: local vital statistics, claims data under title XIX or XXI of the Social Security Act, other public health
p.000525: statistics or surveys, or other data that the Secretary, in consultation with the Director of the
p.000525: Centers for Disease Control and Prevention, deems appropriate.
p.000525: (3) DEFINITION OF ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a
p.000525: public or nonprofit private entity (including a State or political subdivision of a State), or a consortium
p.000525: of any of such entities.
p.000525: (b) COORDINATION WITH OTHER CHILDREN’S PROGRAMS.—An el- igible entity shall identify in the plan submitted
p.000525: as part of an ap- plication for a grant under this section how the entity will coordi- nate operations
p.000525: and activities under the grant with—
p.000525:
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p.000525: January 30, 2020
p.000525: 103 So in law. There are two paragraphs (2) in subsection (a). The second paragraph (2) and paragraph
p.000525: (3) probably should be redesignated as paragraphs (3) and (4), respectively. See sec- tion 501 of Public Law 106–310
p.000525: (114 Stat. 1113).
p.000525: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000525:
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p.000527: (iv) the student’s parent or guardian has com- pleted and submitted to the school any written docu-
p.000527: mentation required by the school, including the treat- ment plan formulated under clause (iii) and other doc-
p.000527: uments related to liability.
p.000527: (B) SCOPE.—An authorization granted under subpara- graph (A) must allow the student involved to possess
p.000527: and use his or her medication—
p.000527: (i) while in school;
p.000527: (ii) while at a school-sponsored activity, such as a sporting event; and
p.000527: (iii) in transit to or from school or school-spon- sored activities.
p.000527: (C) DURATION OF AUTHORIZATION.—An authorization granted under subparagraph (A)—
p.000527: (i) must be effective only for the same school and school year for which it is granted; and
p.000527: (ii) must be renewed by the parent or guardian each subsequent school year in accordance with this
p.000527: subsection.
p.000527: (D) BACKUP MEDICATION.—The State must require that backup medication, if provided by a student’s
p.000527: parent or guardian, be kept at a student’s school in a location to which the student has immediate access in
p.000527: the event of an asthma or anaphylaxis emergency.
p.000527: (E) MAINTENANCE OF INFORMATION.—The State must require that information described in subparagraphs
p.000527: (A)(iii) and (A)(iv) be kept on file at the student’s school in a location easily accessible in the event of an
p.000527: asthma or anaphylaxis emergency.
p.000527: (F) SCHOOL PERSONNEL ADMINISTRATION OF EPINEPH- RINE.—In determining the preference (if any) to be
p.000527: given to a State under this subsection, the Secretary shall give additional preference to a State that
p.000527: provides to the Sec- retary the certification described in subparagraph (G) and that requires that each public
p.000527: elementary school and sec- ondary school in the State—
p.000527: (i) permits trained personnel of the school to ad- minister epinephrine to any student of the school rea-
p.000527: sonably believed to be having an anaphylactic reac- tion;
p.000527: (ii) maintains a supply of epinephrine in a secure location that is easily accessible to trained personnel of
p.000527: the school for the purpose of administration to any student of the school reasonably believed to be having an
p.000527: anaphylactic reaction; and
p.000527: (iii) has in place a plan for having on the premises of the school during all operating hours of the school
p.000527: one or more individuals who are trained personnel of the school.
p.000527: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000527:
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p.000527: Sec. 399M PUBLIC HEALTH SERVICE ACT 528
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p.000527: January 30, 2020
p.000527:
p.000527: (G) CIVIL LIABILITY PROTECTION LAW.—The certifi- cation required in subparagraph (F) shall be a
p.000527: certification made by the State attorney general that the State has re- viewed any applicable civil liability
p.000527: protection law to deter- mine the application of such law with regard to elemen- tary and secondary school
p.000527: trained personnel who may ad- minister epinephrine to a student reasonably believed to be having an
p.000527: anaphylactic reaction and has concluded that such law provides adequate civil liability protection appli- cable
p.000527: to such trained personnel. For purposes of the pre- vious sentence, the term ‘‘civil liability protection
p.000527: law’’ means a State law offering legal protection to individuals who give aid on a voluntary basis in
p.000527: an emergency to an individual who is ill, in peril, or otherwise incapacitated.
p.000527: (2) RULE OF CONSTRUCTION.—Nothing in this subsection creates a cause of action or in any other way
p.000527: increases or di- minishes the liability of any person under any other law.
p.000527: (3) DEFINITIONS.—For purposes of this subsection:
p.000527: (A) The terms ‘‘elementary school’’ and ‘‘secondary school’’ have the meaning given to those terms
p.000527: in section 8101 of the Elementary and Secondary Education Act of 1965.
p.000527: (B) The term ‘‘health care practitioner’’ means a per- son authorized under law to prescribe drugs subject to
p.000527: sec- tion 503(b) of the Federal Food, Drug, and Cosmetic Act.
p.000527: (C) The term ‘‘medication’’ means a drug as that term is defined in section 201 of the Federal Food, Drug,
p.000527: and Cosmetic Act and includes inhaled bronchodilators and auto-injectable epinephrine.
p.000527: (D) The term ‘‘self-administration’’ means a student’s discretionary use of his or her prescribed asthma
p.000527: or ana- phylaxis medication, pursuant to a prescription or written direction from a health care practitioner.
p.000527: (E) The term ‘‘trained personnel’’ means, with respect to an elementary or secondary school, an individual—
p.000527: (i) who has been designated by the principal (or other appropriate administrative staff) of the school to
...

p.000571: of other agencies, and in consultation with appropriate health professional associations, shall develop and carry
p.000571: out a program to educate and train health professionals in effective strategies to—
p.000571: (1) better identify and assess patients with obesity or an eating disorder or patients at-risk of
p.000571: becoming obese or devel- oping an eating disorder;
p.000571: (2) counsel, refer, or treat patients with obesity or an eat- ing disorder; and
p.000571: (3) educate patients and their families about effective strategies to improve dietary habits and
p.000571: establish appropriate levels of physical activity.
p.000571: (b) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000571: sums as may be necessary for each of the fiscal years 2001 through 2005.
p.000571: SEC. 399Z–1. ø280h–5¿ SCHOOL-BASED HEALTH CENTERS.
p.000571: (a) DEFINITIONS; ESTABLISHMENT OF CRITERIA.—In this section:
p.000571: (1) COMPREHENSIVE PRIMARY HEALTH SERVICES.—The term ‘‘comprehensive primary health services’’ means the core
p.000571: serv- ices offered by school-based health centers, which shall include the following:
p.000571: (A) PHYSICAL.—Comprehensive health assessments, diagnosis, and treatment of minor, acute, and chronic med- ical
p.000571: conditions, and referrals to, and follow-up for, spe- cialty care and oral and vision health services.
p.000571: (B) MENTAL HEALTH.—Mental health and substance use disorder assessments, crisis intervention, counseling,
p.000571: treatment, and referral to a continuum of services includ- ing emergency psychiatric care, community
p.000571: support pro- grams, inpatient care, and outpatient programs.
p.000571: (2) MEDICALLY UNDERSERVED CHILDREN AND ADOLES- CENTS.—
p.000571: (A) IN GENERAL.—The term ‘‘medically underserved children and adolescents’’ means a population of children
p.000571: and adolescents who are residents of an area designated as a medically underserved area or a health
p.000571: professional shortage area by the Secretary.
p.000571: (B) CRITERIA.—The Secretary shall prescribe criteria for determining the specific shortages of personal
p.000571: health services for medically underserved children and adoles- cents under subparagraph (A) that shall—
p.000571: (i) take into account any comments received by the Secretary from the chief executive officer of a State
p.000571: and local officials in a State; and
p.000571: (ii) include factors indicative of the health status of such children and adolescents of an area, including the
p.000571: ability of the residents of such area to pay for health services, the accessibility of such services,
p.000571: the availability of health professionals to such children
p.000571: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000585: programs;
p.000585: (C) recommendations on establishing best practices guidelines to ensure interdisciplinary coordination between all
p.000585: relevant service providers receiving Federal funding;
p.000585: (D) comprehensive approaches to improving health outcomes and well-being for individuals with autism spec-
p.000585: trum disorder, including—
p.000585: (i) community-based behavioral supports and interventions;
p.000585: (ii) nutrition, recreational, and social activities;
p.000585: and
p.000585: (iii) personal safety services related to public safe-
p.000585:
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p.000585: January 30, 2020
p.000585: ty agencies or the criminal justice system for such in- dividuals; and
p.000585: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000585:
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p.000587: 587
p.000587: PUBLIC HEALTH SERVICE ACT
p.000587: Sec. 399HH
p.000587:
p.000587: (E) recommendations that seek to improve health out- comes for such individuals, including across their lifespan, by
p.000587: addressing—
p.000587: (i) screening and diagnosis of children and adults;
p.000587: (ii) behavioral and other therapeutic approaches;
p.000587: (iii) primary and preventative care;
p.000587: (iv) communication challenges;
p.000587: (v) aggression, self-injury, elopement, and other behavioral issues;
p.000587: (vi) emergency room visits and acute care hos- pitalization;
p.000587: (vii) treatment for co-occurring physical and men- tal health conditions;
p.000587: (viii) premature mortality;
p.000587: (ix) medical practitioner training; and
p.000587: (x) caregiver mental health.
p.000587: SEC. 399EE. ø280i–4¿ AUTHORIZATION OF APPROPRIATIONS.
p.000587: (a) DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RE- SEARCH PROGRAM.—To carry out section 399AA, there is
p.000587: authorized to be appropriated $23,100,000 for each of fiscal years 2020 through 2024.
p.000587: (b) AUTISM EDUCATION, EARLY DETECTION, AND INTERVEN- TION.—To carry out section 399BB, there is authorized
p.000587: to be appro- priated $50,599,000 for each of fiscal years 2020 through 2024.
p.000587: (c) INTERAGENCY AUTISM COORDINATING COMMITTEE; CERTAIN OTHER PROGRAMS.—To carry out sections 399CC and
p.000587: 409C, there are authorized to be appropriated $296,000,000 for each of fiscal years 2020 through 2024.
p.000587: PART S—HEALTH CARE QUALITY PROGRAMS
p.000587: Subpart I—National Strategy for Quality Improvement in Health Care
p.000587:
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p.000587: January 30, 2020
p.000587: SEC. 399HH. ø280j¿ NATIONAL STRATEGY FOR QUALITY IMPROVEMENT IN HEALTH CARE.
p.000587: (a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.—
p.000587: (1) NATIONAL STRATEGY.—The Secretary, through a trans- parent collaborative process, shall establish a national
p.000587: strategy to improve the delivery of health care services, patient health outcomes, and population health.
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p.000699: utilization of collaborative ef- forts with both the public and private sectors to—
p.000699: (1) increase the awareness and knowledge of health care professionals and the public regarding the
p.000699: prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and
p.000699: (2) develop and disseminate to health professionals, pa- tients and patient families, and the public
p.000699: information de- signed to encourage adults and children to adopt healthful practices concerning the prevention
p.000699: of such diseases.
p.000699: NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD RESOURCES PROGRAM
p.000699: SEC. 421. ø285b–3¿ (a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources
p.000699: Program (hereafter in this subpart referred to as the ‘‘Program’’ may provide for—
p.000699: (A) investigation into the epidemiology, etiology, and pre- vention of all forms and aspects of heart,
p.000699: blood vessel, lung, and blood diseases, including investigations into the social, en- vironmental, behavioral,
p.000699: nutritional, biological, and genetic de- terminants and influences involved in the epidemiology, eti- ology, and
p.000699: prevention of such diseases;
p.000699: (B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and
p.000699: abnor- mal heart, blood vessel, lung, and blood phenomena;
p.000699: (C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers)
p.000699: used in, and approaches to, the diagnosis, treatment (including the pro- vision of emergency medical services), and
p.000699: prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such
p.000699: diseases;
p.000699: (D) establishment of programs that will focus and apply scientific and technological efforts involving
p.000699: the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood
p.000699: diseases with emphasis on the refine- ment, development, and evaluation of technological devices that will
p.000699: assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of
p.000699: and rehabilitation from such diseases;
p.000699: (E) establishment of programs for the conduct and direc- tion of field studies, large-scale testing and
p.000699: evaluation, and demonstration of preventive, diagnostic, therapeutic, and reha-
p.000699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000699:
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p.000699: Sec. 421 PUBLIC HEALTH SERVICE ACT 700
p.000699:
p.000699: bilitative approaches to, and emergency medical services for, such diseases;
p.000699: (F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects
p.000699: of the management of blood resources in the United States, including the collection, preservation, fractionation,
p.000699: and distribution of blood and blood products;
p.000699: (G) the education (including continuing education) and training of scientists, clinical investigators, and
p.000699: educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs
p.000699: respecting heart, blood vessel, lung, and blood diseases and blood resources;
p.000699: (H) public and professional education relating to all as- pects of such diseases, including the
p.000699: prevention of such dis- eases, and the use of blood and blood products and the man- agement of blood
p.000699: resources;
p.000699: (I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of
p.000699: children (includ- ing cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and
p.000699: Cooley’s anemia, and hemophilic dis- eases) and for the development and demonstration of diag- nostic,
p.000699: treatment, and preventive approaches to such diseases; and
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p.000699: (J) establishment of programs for study, research, develop- ment, demonstrations and evaluation of emergency
p.000699: medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.
p.000699: (2) The Program shall be coordinated with other national re- search institutes to the extent that they
p.000699: have responsibilities re- specting such diseases and shall give special emphasis to the con- tinued
p.000699: development in the Institute of programs related to the causes of stroke and to effective coordination of such
p.000699: programs with related stroke programs in the National Institute of Neurological and Communicative Disorders
p.000699: and Stroke. The Director of the In- stitute, with the advice of the advisory council for the Institute,
p.000699: shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
p.000699: (b) In carrying out the Program, the Director of the Institute, under policies established by the Director of
p.000699: NIH—
p.000699: (1) may, after consultation with the advisory council for the Institute, obtain (in accordance with
p.000699: section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period
p.000699: of such service) the services of not more than one hundred experts or consultants who have sci- entific
p.000699: or professional qualifications;
p.000699: (2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve,
p.000699: repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood
p.000699: resource laboratories, research, train- ing, and other facilities, equipment, and such other real or per- sonal
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p.000701: programs.
p.000701: Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (1) shall be paid
p.000701: or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place
p.000701: of service and for other expenses associated with their assignment. Such expenses shall not be allowed
p.000701: in con- nection with the assignment of an expert or consultant whose serv- ices are obtained under paragraph (1)
p.000701: unless the expert or consult- ant has agreed in writing to complete the entire period of the as- signment
p.000701: or one year of the assignment, whichever is shorter, un- less separated or reassigned for reasons which are
p.000701: beyond the con- trol of the expert or consultant and which are acceptable to the Di- rector of the Institute. If
p.000701: the expert or consultant violates the agreement, the money spent by the United States for such ex-
p.000701: penses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive
p.000701: in whole or in part a right of recovery under the preceding sentence.
p.000701: NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES, SICKLE
p.000701: CELL ANEMIA, AND BLOOD RESOURCES
p.000701: SEC. 422. ø285b–4¿ (a)(1) The Director of the Institute may provide, in accordance with subsection (c), for
p.000701: the development of—
p.000701: (A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services)
p.000701: for heart and blood ves- sel diseases;
p.000701: (B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment and rehabilitation methods (including methods of providing emergency medical
p.000701: services) for lung diseases (in-
p.000701: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000701:
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p.000701: Sec. 422 PUBLIC HEALTH SERVICE ACT 702
p.000701:
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p.000701: January 30, 2020
p.000701:
p.000701: cluding bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children);
p.000701: (C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and
p.000701: research into blood, in the use of blood products and in the management of blood re- sources; and
p.000701: (D) three centers for basic and clinical research into, train- ing in, and demonstration of, advanced diagnostic,
p.000701: prevention, and treatment (including genetic studies, intrauterine environ- ment studies, postnatal studies, heart
p.000701: arrhythmias, and ac- quired heart disease and preventive cardiology) for cardio- vascular diseases in
p.000701: children.
p.000701: (2) The centers developed under paragraph (1) shall, in addi- tion to being utilized for research, training,
p.000701: and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood
p.000701: diseases:
p.000701: (A) Programs to develop improved methods of detecting in- dividuals with a high risk of developing
p.000701: cardiovascular, pul- monary, and blood diseases.
p.000701: (B) Programs to develop improved methods of intervention against those factors which cause individuals to have
p.000701: a high risk of developing such diseases.
p.000701: (C) Programs to develop health professions and allied health professions personnel highly skilled in the
p.000701: prevention of such diseases.
p.000701: (D) Programs to develop improved methods of providing emergency medical services for persons with such diseases.
p.000701: (E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and
p.000701: treat- ment of such diseases and the maintenance of health to reduce the incidence of such diseases and
p.000701: information programs for the public respecting the prevention and early diagnosis and treatment of such
p.000701: diseases and the maintenance of health.
p.000701: (3) The research, training, and demonstration activities carried out through any such center may relate to any one or
p.000701: more of the diseases referred to in paragraph (1) of this subsection.
p.000701: (b) The Director of the Institute shall provide, in accordance with subsection (c), for the development of ten
p.000701: centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia.
p.000701: (c)(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or
p.000701: private nonprofit en- tities to pay all or part of the cost of planning, establishing, or strengthening,
p.000701: and providing basic operating support for centers for basic and clinical research into, training in, and
p.000701: demonstration of the management of blood resources and advanced diagnostic, pre- vention, and treatment
p.000701: methods for heart, blood vessel, lung, or blood diseases.
p.000701: (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies
p.000701: established by the Di- rector of NIH and after consultation with the Institute’s advisory council.
p.000701: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000701:
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p.000745: (H) alcoholism and alcohol abuse among women;
p.000745: (4) secure from time to time and for such periods as he deems advisable, the assistance and advice of
p.000745: experts, scholars, and consultants from the United States or abroad;
p.000745: (5) promote the coordination of research programs con- ducted by the Institute, and similar programs conducted
p.000745: by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals,
p.000745: including all National Institutes of Health research activities which are or may be re- lated to the problems of
p.000745: individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alco- hol abuse
p.000745: on other health problems;
p.000745: (6) conduct an intramural program of biomedical, behav- ioral, epidemiological, and social research,
p.000745: including research into the most effective means of treatment and service deliv- ery, and including
p.000745: research involving human subjects, which is—
p.000745: (A) located in an institution capable of providing all necessary medical care for such human subjects,
p.000745: including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and
p.000745: intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is
p.000745: determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
p.000745:
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p.000745: (B) associated with an accredited medical or research training institution;
p.000745: (7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health
p.000745: Service, persons not otherwise eligible for such treatment;
p.000745: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000747: 747
p.000747: PUBLIC HEALTH SERVICE ACT
p.000747: Sec. 464J
p.000747:
p.000747: (8) provide to health officials, scientists, and appropriate public and other nonprofit institutions and
p.000747: organizations, tech- nical advice and assistance on the application of statistical and other scientific research
p.000747: methods to experiments, studies, and surveys in health and medical fields;
p.000747: (9) enter into contracts under this title without regard to sections 3648 and 3709 of the Revised
p.000747: Statutes (31 U.S.C. 529; 39 41 U.S.C. 5); and
p.000747: (10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and Alcoholism, such
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p.000807: regarding a project of research described in subsection (b), the Secretary—
p.000807: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000807:
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p.000807: Sec. 494 PUBLIC HEALTH SERVICE ACT 808
p.000807:
p.000807: (1) shall require that, as a condition of receiving assist- ance, the entity disclose the existence of a
p.000807: financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and
p.000807: (2) may take such other actions as the Secretary deter- mines to be appropriate.
p.000807: (f) DEFINITIONS.—For purposes of this section:
p.000807: (1) The term ‘‘financial interest’’ includes the receipt of consulting fees or honoraria and the ownership of
p.000807: stock or eq- uity.
p.000807: (2) The term ‘‘assistance’’, with respect to conducting a project of research, means a grant, contract,
p.000807: or cooperative agreement.
p.000807: RESEARCH ON PUBLIC HEALTH EMERGENCIES
p.000807: SEC. 494. ø289c¿ If the Secretary determines, after consulta- tion with the Director of NIH, the
p.000807: Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and
p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
p.000807: part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental
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p.000813: of silicone
p.000813: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000815: 815
p.000815: PUBLIC HEALTH SERVICE ACT
p.000815: Sec. 498D
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p.000815: breast implants, both gel and saline filled. Such research studies may include the following:
p.000815: (1) Developing and examining techniques to measure con- centrations of silicone in body fluids and tissues.
p.000815: (2) Surveillance of recipients of silicone breast implants, including long-term outcomes and local
p.000815: complications.
p.000815: (b) DEFINITION.—For purposes of this section, the term ‘‘breast implant’’ means a breast prosthesis that is
p.000815: implanted to augment or reconstruct the female breast.
p.000815: SEC. 498D. ø289g–4¿ SUPPORT FOR EMERGENCY MEDICINE RESEARCH.
p.000815: (a) EMERGENCY MEDICAL RESEARCH.—The Secretary shall sup- port Federal programs administered by the National
p.000815: Institutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and
p.000815: Services Administration, the Centers for Dis- ease Control and Prevention, and other agencies involved in im-
p.000815: proving the emergency care system to expand and accelerate re- search in emergency medical care systems
p.000815: and emergency medi- cine, including—
p.000815: (1) the basic science of emergency medicine;
p.000815: (2) the model of service delivery and the components of such models that contribute to enhanced patient
p.000815: health out- comes;
p.000815: (3) the translation of basic scientific research into im- proved practice; and
p.000815: (4) the development of timely and efficient delivery of health services.
p.000815: (b) PEDIATRIC EMERGENCY MEDICAL RESEARCH.—The Secretary shall support Federal programs administered by the National
p.000815: Insti- tutes of Health, the Agency for Healthcare Research and Quality, the Health Resources and Services
p.000815: Administration, the Centers for Disease Control and Prevention, and other agencies to coordinate and expand
p.000815: research in pediatric emergency medical care systems and pediatric emergency medicine, including—
p.000815: (1) an examination of the gaps and opportunities in pedi- atric emergency care research and a strategy
p.000815: for the optimal organization and funding of such research;
p.000815: (2) the role of pediatric emergency services as an inte- grated component of the overall health system;
p.000815: (3) system-wide pediatric emergency care planning, pre- paredness, coordination, and funding;
p.000815: (4) pediatric training in professional education; and
p.000815: (5) research in pediatric emergency care, specifically on the efficacy, safety, and health outcomes of
p.000815: medications used for infants, children, and adolescents in emergency care settings in order to improve patient
p.000815: safety.
p.000815: (c) IMPACT RESEARCH.—The Secretary shall support research to determine the estimated economic impact of, and
p.000815: savings that re- sult from, the implementation of coordinated emergency care sys- tems.
p.000815: (d) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000815: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000815: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000815: Sec. 498E PUBLIC HEALTH SERVICE ACT 816
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p.000815: January 30, 2020
p.000815:
p.000815: SEC. 498E. ø289g–5¿ PRECISION MEDICINE INITIATIVE.
p.000815: (a) IN GENERAL.—The Secretary is encouraged to establish and carry out an initiative, to be known as the ‘‘Precision
p.000815: Medicine Ini- tiative’’ (in this section referred to as the ‘‘Initiative’’), to augment efforts to address
p.000815: disease prevention, diagnosis, and treatment.
p.000815: (b) COMPONENTS.—The Initiative described under subsection
p.000815: (a) may include—
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p.000835: not make such an award unless—
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000835: Sec. 501A PUBLIC HEALTH SERVICE ACT 836
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p.000835:
p.000835: (1) an application for the award is submitted to the official involved;
p.000835: (2) with respect to carrying out the purpose for which the award is to be provided, the application provides
p.000835: assurances of compliance satisfactory to such official; and
p.000835: (3) the application is otherwise in such form, is made in such manner, and contains such agreements,
p.000835: assurances, and information as the official determines to be necessary to carry out the purpose for which the award is
p.000835: to be provided.
p.000835: (o) EMERGENCY RESPONSE.—
p.000835: (1) IN GENERAL.—Notwithstanding section 504 and except as provided in paragraph (2), the Secretary may use not to
p.000835: ex- ceed 2.5 percent of all amounts appropriated under this title for a fiscal year to make
p.000835: noncompetitive grants, contracts or cooperative agreements to public entities to enable such enti- ties to
p.000835: address emergency substance abuse or mental health needs in local communities.
p.000835: (2) EXCEPTIONS.—Amounts appropriated under part C shall not be subject to paragraph (1).
p.000835: (3) EMERGENCIES.—The Secretary shall establish criteria for determining that a substance abuse or mental health
p.000835: emer- gency exists and publish such criteria in the Federal Register prior to providing funds under this
p.000835: subsection.
p.000835: (4) EMERGENCY RESPONSE.—Amounts made available for carrying out this subsection shall remain available through the
p.000835: end of the fiscal year following the fiscal year for which such amounts are appropriated.
p.000835: (p) LIMITATION ON THE USE OF CERTAIN INFORMATION.—No in- formation, if an establishment or person supplying the
p.000835: information or described in it is identifiable, obtained in the course of activities undertaken or supported under
p.000835: section 505 may be used for any purpose other than the purpose for which it was supplied unless such
p.000835: establishment or person has consented (as determined under regulations of the Secretary) to its use for such
p.000835: other purpose. Such information may not be published or released in other form if the person who supplied
p.000835: the information or who is described in it is identifiable unless such person has consented (as determined under
p.000835: regulations of the Secretary) to its publication or release in other form.
p.000835: (q) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing grants, cooperative agreements, and contracts
p.000835: under this section, there are authorized to be appropriated $25,000,000 for fis- cal year 2001, and such sums as may be
p.000835: necessary for each of the fiscal years 2002 and 2003.
p.000835: SEC. 501A. ø290aa–0¿ NATIONAL MENTAL HEALTH AND SUBSTANCE USE POLICY LABORATORY.
p.000835: (a) IN GENERAL.—There shall be established within the Admin- istration a National Mental Health and Substance Use
p.000835: Policy Lab- oratory (referred to in this section as the ‘‘Laboratory’’).
p.000835: (b) RESPONSIBILITIES.—The Laboratory shall—
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p.000843: (2) provide statistical and analytical support for activities of the Administration;
p.000843: (3) recommend a core set of performance metrics to evalu- ate activities supported by the Administration; and
p.000843: (4) coordinate with the Assistant Secretary, the Assistant Secretary for Planning and Evaluation, and the
p.000843: Chief Medical Officer appointed under section 501(g), as appropriate, to im- prove the quality of services
p.000843: provided by programs of the Ad- ministration and the evaluation of activities carried out by the Administration.
p.000843: (c) MENTAL HEALTH.—With respect to the activities of the Di- rector under subsection (b)(1) relating to mental
p.000843: health, the Direc- tor shall ensure that such activities include, at a minimum, the col- lection of data on—
p.000843: (1) the number and variety of public and nonprofit private treatment programs;
p.000843: (2) the number and demographic characteristics of individ- uals receiving treatment through such programs;
p.000843: (3) the type of care received by such individuals; and
p.000843: (4) such other data as may be appropriate.
p.000843: (d) SUBSTANCE ABUSE.—
p.000843: (1) IN GENERAL.—With respect to the activities of the Di- rector under subsection (b)(1) relating to
p.000843: substance abuse, the Director shall ensure that such activities include, at a min- imum, the collection of
p.000843: data on—
p.000843: (A) the number of individuals admitted to the emergency rooms of hospitals as a result of the abuse of
p.000843: alcohol or other drugs;
p.000843: (B) the number of deaths occurring as a result of substance abuse, as indicated in reports by coroners in coordination
p.000843: with the Centers for Disease Control and Prevention;
p.000843: (C) the number and variety of public and private nonprofit treatment programs, including the number and type of patient
p.000843: slots available;
p.000843: (D) the number of individuals seeking treatment through such programs, the number and demographic
p.000843: characteristics of individuals receiving such treatment, the percentage of individ-
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843:
p.000843: January 30, 2020
p.000843: ‘‘The Secretary of Health and Human Services shall develop a public health monitoring pro- gram to monitor
p.000843: methamphetamine abuse in the United States. The program shall include the collection and dissemination of data
p.000843: related to methamphetamine abuse which can be used by public health officials in policy development.’’.
p.000843: 3 So in law. The period at the end of subparagraph (B) probably should be a semicolon.
p.000843: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000843:
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p.000845: PUBLIC HEALTH SERVICE ACT
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p.000881:
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p.000881: January 30, 2020
p.000881: lyze the effectiveness and efficacy of the activities con- ducted with grants, collaborations, and
p.000881: consultations under this section.
p.000881: (h) RULE OF CONSTRUCTION; STUDENT MEDICATION.—Nothing in this section or section 520E–1 shall be construed to
p.000881: allow school personnel to require that a student obtain any medication as a con- dition of attending school or
p.000881: receiving services.
p.000881: (i) PROHIBITION.—Funds appropriated to carry out this section, section 520C, section 520E–1, or section 520E–2
p.000881: shall not be used to pay for or refer for abortion.
p.000881: (j) PARENTAL CONSENT.—States and entities receiving funding under this section and section 520E–1 shall
p.000881: obtain prior written, informed consent from the child’s parent or legal guardian for as- sessment
p.000881: services, school-sponsored programs, and treatment in- volving medication related to youth suicide conducted
p.000881: in elemen- tary and secondary schools. The requirement of the preceding sen- tence does not apply in the following
p.000881: cases:
p.000881: (1) In an emergency, where it is necessary to protect the immediate health and safety of the student
p.000881: or other students.
p.000881: (2) Other instances, as defined by the State, where paren- tal consent cannot reasonably be obtained.
p.000881: (k) RELATION TO EDUCATION PROVISIONS.—Nothing in this sec- tion or section 520E–1 shall be construed to supersede
p.000881: section 444 of the General Education Provisions Act, including the requirement of prior parental consent for
p.000881: the disclosure of any education records. Nothing in this section or section 520E–1 shall be con-
p.000881: strued to modify or affect parental notification requirements for
p.000881: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000883: PUBLIC HEALTH SERVICE ACT
p.000883: Sec. 520E–1
p.000883:
p.000883: programs authorized under the Elementary and Secondary Edu- cation Act of 1965 (as amended by the No
p.000883: Child Left Behind Act of 2001; Public Law 107–110).
p.000883: (l) DEFINITIONS.—In this section:
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p.000887: institutions of higher education, including efforts to reduce the incidence of suicide and substance use
p.000887: disorders.
p.000887: (g) DEFINITION.—In this section, the term ‘‘institution of higher education’’ has the meaning given such term in
p.000887: section 101 of the Higher Education Act of 1965.
p.000887: (h) TECHNICAL ASSISTANCE.—The Secretary may provide tech- nical assistance to grantees in carrying out this
p.000887: section.
p.000887: (i) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000887: to be appropriated
p.000887: $7,000,000 for each of fiscal years 2018 through 2022.
p.000887: SEC. 520E–3. ø290bb–36c¿ NATIONAL SUICIDE PREVENTION LIFELINE PROGRAM.
p.000887: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Suicide
p.000887: Prevention Lifeline program (referred to in this section as the ‘‘program’’), authorized under section 520A
p.000887: and in effect prior to the date of enactment of the Helping Families in Mental Health Crisis Reform Act of
p.000887: 2016.
p.000887: (b) ACTIVITIES.—In maintaining the program, the activities of the Secretary shall include—
p.000887: (1) coordinating a network of crisis centers across the United States for providing suicide prevention and
p.000887: crisis inter- vention services to individuals seeking help at any time, day or night;
p.000887: (2) maintaining a suicide prevention hotline to link callers to local emergency, mental health, and social
p.000887: services re- sources; and
p.000887: (3) consulting with the Secretary of Veterans Affairs to en- sure that veterans calling the suicide prevention
p.000887: hotline have access to a specialized veterans’ suicide prevention hotline.
p.000887: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000887:
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p.000889: 889
p.000889: PUBLIC HEALTH SERVICE ACT
p.000889: Sec. 520F
p.000889:
p.000889: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated $7,198,000
p.000889: for each of fiscal years 2018 through 2022.
p.000889: SEC. 520E–4. ø290bb-36d¿ TREATMENT REFERRAL ROUTING SERVICE.
p.000889: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary, shall maintain the National Treatment
p.000889: Referral Routing Service (referred to in this section as the ‘‘Routing Service’’) to as- sist individuals and
p.000889: families in locating mental and substance use disorders treatment providers.
p.000889: (b) ACTIVITIES OF THE SECRETARY.—To maintain the Routing Service, the activities of the Assistant
p.000889: Secretary shall include ad- ministering—
p.000889: (1) a nationwide, telephone number providing year-round access to information that is updated on a
p.000889: regular basis re- garding local behavioral health providers and community- based organizations in a
...

p.000889: individuals with a substance use disorder.
p.000889: (b) APPLICATIONS.—
p.000889: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000889:
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p.000889: Sec. 520F PUBLIC HEALTH SERVICE ACT 890
p.000889: (1) IN GENERAL.—To receive a grant under subsection (a), an entity shall submit to the Secretary an
p.000889: application, at such time, in such manner, and containing such information as the Secretary may require.
p.000889: (2) COMMUNITY-BASED CRISIS RESPONSE PLAN.—An applica- tion for a grant under subsection (a)(1) shall include
p.000889: a plan for—
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p.000889: January 30, 2020
p.000889: (A) promoting integration and coordination between local public and private entities engaged in crisis response,
p.000889: including first responders, emergency health care pro- viders, primary care providers, law enforcement,
p.000889: court sys- tems, health care payers, social service providers, and be- havioral health providers;
p.000889: (B) developing memoranda of understanding with pub- lic and private entities to implement crisis response serv-
p.000889: ices;
p.000889: (C) addressing gaps in community resources for crisis intervention and prevention; and
p.000889: (D) developing models for minimizing hospital re- admissions, including through appropriate discharge plan-
p.000889: ning.
p.000889: (3) BEDS DATABASE PLAN.—An application for a grant under subsection (a)(2) shall include a plan
p.000889: for developing, maintaining, or enhancing a real-time, Internet-based bed database to collect,
p.000889: aggregate, and display information about beds in inpatient psychiatric facilities and crisis stabilization
p.000889: units, and residential community mental health and residen- tial substance use disorder treatment facilities to
p.000889: facilitate the identification and designation of facilities for the temporary treatment of individuals in
p.000889: mental or substance use disorder crisis.
p.000889: (c) DATABASE REQUIREMENTS.—A bed database described in this section is a database that—
p.000889: (1) includes information on inpatient psychiatric facilities, crisis stabilization units, and residential
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p.000893: evaluation of activities funded with an award under such subsection, including a process and outcomes
p.000893: evalua- tion.
p.000893: (h) EVALUATION.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under this subsection shall prepare
p.000893: and submit a plan for the rigorous evalua- tion of the program funded under such grant, contract, or agree-
p.000893: ment, including both process and outcomes evaluation, and the submission of an evaluation at the end of the
p.000893: project period.
p.000893: (i) AUTHORIZATION OF APPROPRIATION.—There is authorized to be appropriated to carry out this subsection
p.000893: $40,000,000 for fiscal year 2001, and such sums as may be necessary for fiscal years 2002 through 2003.
p.000893: SEC. 520J. ø290bb–41¿ MENTAL HEALTH AWARENESS TRAINING GRANTS.
p.000893: (a) IN GENERAL.—The Secretary shall award grants in accord- ance with the provisions of this section.
p.000893: (b) MENTAL HEALTH AWARENESS TRAINING GRANTS.—
p.000893: (1) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian tribes,
p.000893: tribal or- ganizations, and nonprofit private entities to train teachers and other relevant school personnel
p.000893: to recognize symptoms of childhood and adolescent mental disorders, to refer family members to the
p.000893: appropriate mental health services if nec- essary, to train emergency services personnel veterans, law en-
p.000893: forcement, and other categories of individuals, as determined by the Secretary, to identify and appropriately
p.000893: respond to per- sons with a mental illness, and to provide education to such
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000895: 895
p.000895: PUBLIC HEALTH SERVICE ACT
p.000895: Sec. 520K
p.000895:
p.000895: teachers and personnel regarding resources that are available in the community for individuals with a mental
p.000895: illness.
p.000895: (2) EMERGENCY SERVICES PERSONNEL 13.—In this sub- section, the term ‘‘emergency services personnel’’
p.000895: includes para- medics, firefighters, and emergency medical technicians.
p.000895: (3) DISTRIBUTION OF AWARDS 13.—The Secretary shall en- sure that such grants awarded under this subsection are
p.000895: equi- tably distributed among the geographical regions of the United States and between urban and rural populations.
p.000895: (4) APPLICATION.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private entity that desires a grant under this subsection shall submit an ap- plication to the Secretary at such
p.000895: time, in such manner, and containing such information as the Secretary may require, in- cluding a plan for
p.000895: the rigorous evaluation of activities that are carried out with funds received under a grant under this sub-
p.000895: section.
p.000895: (5) USE OF FUNDS.—A State, political subdivision of a State, Indian tribe, tribal organization, or nonprofit
p.000895: private en- tity receiving a grant under this subsection shall use funds from such grant for
p.000895: evidence-based programs that provide training and education in accordance with paragraph (1) on matters
p.000895: including—
p.000895: (A) recognizing the signs and symptoms of mental ill- ness; and
p.000895: (B)(i) resources available in the community for individ- uals with a mental illness and other relevant resources; or
p.000895: (ii) safely de-escalating crisis situations involving indi- viduals with a mental illness.
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p.000897: centers, com- munity mental health centers that meet the criteria under sec- tion 1913(c), certified community
p.000897: behavioral health clinics de- scribed in section 223 of the Protecting Access to Medicare Act of 2014, primary care
p.000897: organizations such as Federally qualified health centers or rural health clinics as defined in section
p.000897: 1861(aa) of the Social Security Act, other community-based or- ganizations, or other entities engaging in
p.000897: integrated care ac- tivities, as the Secretary determines appropriate.
p.000897: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec-
p.000897: tion, there are authorized to be appropriated $51,878,000 for each of fiscal years 2018 through 2022.
p.000897: SEC. 520L. ø290bb–43¿ ADULT SUICIDE PREVENTION.
p.000897: (a) GRANTS.—
p.000897: (1) IN GENERAL.—The Assistant Secretary shall award grants to eligible entities described in
p.000897: paragraph (2) to imple- ment suicide prevention and intervention programs, for indi- viduals who are 25
p.000897: years of age or older, that are designed to raise awareness of suicide, establish referral processes, and im-
p.000897: prove care and outcomes for such individuals who are at risk of suicide.
p.000897: (2) ELIGIBLE ENTITIES.—To be eligible to receive a grant under this section, an entity shall be a
p.000897: community-based pri- mary care or behavioral health care setting, an emergency de- partment, a State mental health
p.000897: agency (or State health agen- cy with mental or behavioral health functions), public health agency, a
p.000897: territory of the United States, or an Indian tribe or tribal organization (as the terms ‘‘Indian tribe’’
p.000897: and ‘‘tribal or- ganization’’ are defined in section 4 of the Indian Self-Deter- mination and Education
p.000897: Assistance Act).
p.000897: (3) USE OF FUNDS.—The grants awarded under paragraph
p.000897: (1) shall be used to implement programs, in accordance with such paragraph, that include one or more of the
p.000897: following com- ponents:
p.000897:
p.000897:
p.000897:
p.000897:
p.000897: January 30, 2020
p.000897: (A) Screening for suicide risk, suicide intervention services, and services for referral for treatment for
p.000897: individ- uals at risk for suicide.
p.000897: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000897:
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p.000899: PUBLIC HEALTH SERVICE ACT
p.000899: Sec. 520M
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p.000901: (e) SPECIAL RULES.—The Secretary may not make payments under section 521 unless the State involved agrees that
p.000901: grants pur- suant to subsection (a) will not be made to any entity that—
p.000901: (1) has a policy of excluding individuals from mental health services due to the existence or suspicion
p.000901: of a substance use disorder; or
p.000901: (2) has a policy of excluding individuals from substance use disorder services due to the existence or
p.000901: suspicion of men- tal illness.
p.000901: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000901:
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p.000901: Sec. 523 PUBLIC HEALTH SERVICE ACT 902
p.000901: (f) ADMINISTRATIVE EXPENSES.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that not more than 4 percent of the payments will be expended for ad- ministrative
p.000901: expenses regarding the payments.
p.000901: (g) RESTRICTIONS ON USE OF FUNDS.—The Secretary may not make payments under section 521 unless the State
p.000901: involved agrees that—
p.000901: (1) not more than 20 percent of the payments will be ex- pended for housing services under subsection
p.000901: (b)(10); and
p.000901: (2) the payments will not be expended—
p.000901: (A) to support emergency shelters or construction of housing facilities;
p.000901: (B) for inpatient psychiatric treatment costs or inpa- tient substance use disorder treatment costs; or
p.000901: (C) to make cash payments to intended recipients of mental health or substance use disorder services.
p.000901: (h) WAIVER FOR TERRITORIES.—With respect to the United States Virgin Islands, Guam, American Samoa, Palau,
p.000901: the Mar- shall Islands, and the Commonwealth of the Northern Mariana Is- lands, the Secretary may waive the
p.000901: provisions of this part that the Secretary determines to be appropriate.
p.000901: SEC. 523. ø290cc–23¿ REQUIREMENT OF MATCHING FUNDS.
p.000901: (a) IN GENERAL.—The Secretary may not make payments under section 521 unless, with respect to the
p.000901: costs of providing services pursuant to section 522, the State involved agrees to make available, directly or through
p.000901: donations from public or private enti- ties, non-Federal contributions toward such costs in an amount that is
p.000901: not less than $1 for each $3 of Federal funds provided in such payments.
p.000901: (b) DETERMINATION OF AMOUNT.—Non-Federal contributions required in subsection (a) may be in cash or in
p.000901: kind, fairly evalu- ated, including plant, equipment, or services. Amounts provided by the Federal Government, or
p.000901: services assisted or subsidized to any significant extent by the Federal Government, shall not be included in
p.000901: determining the amount of such non-Federal contributions.
p.000901: (c) LIMITATION REGARDING GRANTS BY STATES.—The Secretary may not make payments under section 521 unless the
...

p.000909: SEC. 543. ø290dd–2¿ CONFIDENTIALITY OF RECORDS.
p.000909: (a) REQUIREMENT.—Records of the identity, diagnosis, prog- nosis, or treatment of any patient which are
p.000909: maintained in connec- tion with the performance of any program or activity relating to substance abuse
p.000909: education, prevention, training, treatment, reha- bilitation, or research, which is conducted, regulated, or
p.000909: directly or indirectly assisted by any department or agency of the United States shall, except as provided
p.000909: in subsection (e), be confidential and be disclosed only for the purposes and under the circumstances expressly
p.000909: authorized under subsection (b).
p.000909: (b) PERMITTED DISCLOSURE.—
p.000909: (1) CONSENT.—The content of any record referred to in subsection (a) may be disclosed in accordance with
p.000909: the prior written consent of the patient with respect to whom such record is maintained, but only to
p.000909: such extent, under such cir- cumstances, and for such purposes as may be allowed under regulations
p.000909: prescribed pursuant to subsection (g).
p.000909: (2) METHOD FOR DISCLOSURE.—Whether or not the patient, with respect to whom any given record referred to in
p.000909: sub- section (a) is maintained, gives written consent, the content of such record may be disclosed as follows:
p.000909: (A) To medical personnel to the extent necessary to meet a bona fide medical emergency.
p.000909: (B) To qualified personnel for the purpose of con- ducting scientific research, management audits,
p.000909: financial audits, or program evaluation, but such personnel may not identify, directly or indirectly, any
p.000909: individual patient in any report of such research, audit, or evaluation, or other- wise disclose patient identities
p.000909: in any manner.
p.000909: (C) If authorized by an appropriate order of a court of competent jurisdiction granted after application showing
p.000909: good cause therefor, including the need to avert a substan- tial risk of death or serious bodily harm. In assessing
p.000909: good cause the court shall weigh the public interest and the need for disclosure against the injury to the
p.000909: patient, to the physician-patient relationship, and to the treatment serv- ices. Upon the granting of such
p.000909: order, the court, in deter-
p.000909: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000911: PUBLIC HEALTH SERVICE ACT
p.000911: Sec. 543A
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p.000911: priorities identified in the stra- tegic plan under section 501(l).
p.000911: (c) REQUIREMENTS.—The Assistant Secretary may establish minimum requirements for the applications
p.000911: submitted under sub- section (b), including applications related to the submission of re- search and
p.000911: evaluation.
p.000911: (d) REVIEW AND RATING.—
p.000911: (1) IN GENERAL.—The Assistant Secretary shall review ap- plications prior to public posting in accordance with
p.000911: subsection (a), and may prioritize the review of applications for evidence- based programs and practices that are
p.000911: related to topics in- cluded in the notice provided under subsection (b)(2).
p.000911: (2) SYSTEM.—In carrying out paragraph (1), the Assistant Secretary may utilize a rating and review
p.000911: system, which may include information on the strength of evidence associated with the evidence-based programs and
p.000911: practices and a rating of the methodological rigor of the research supporting the applica- tions.
p.000911: (3) PUBLIC ACCESS TO METRICS AND RATING.—The Assistant Secretary shall make the metrics used to evaluate
p.000911: applications under this section, and any resulting ratings of such applica- tions, publicly available.
p.000911: SEC. 544. ø290dd–3¿ GRANTS FOR REDUCING OVERDOSE DEATHS.
p.000911: (a) ESTABLISHMENT.—
p.000911: (1) IN GENERAL.—The Secretary shall award grants to eli- gible entities to expand access to drugs or devices
p.000911: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000911: suspected opioid overdose.
p.000911: (2) MAXIMUM GRANT AMOUNT.—A grant awarded under this section may not be for more than $200,000 per grant year.
p.000911: (3) ELIGIBLE ENTITY.—For purposes of this section, the term ‘‘eligible entity’’ means a Federally qualified
p.000911: health center (as defined in section 1861(aa) of the Social Security Act), an
p.000911: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000913: 913
p.000913: PUBLIC HEALTH SERVICE ACT
p.000913: Sec. 544
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p.000913: opioid treatment program under part 8 of title 42, Code of Fed- eral Regulations, any practitioner dispensing
p.000913: narcotic drugs pursuant to section 303(g) of the Controlled Substances Act, or any other entity that the Secretary
p.000913: deems appropriate.
p.000913: (4) PRESCRIBING.—For purposes of this section, the term ‘‘prescribing’’ means, with respect to a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000913: opioid overdose, the practice of prescribing such drug or device—
p.000913: (A) in conjunction with an opioid prescription for pa- tients at an elevated risk of overdose;
p.000913: (B) in conjunction with an opioid agonist approved under section 505 of the Federal Food, Drug, and Cosmetic Act
p.000913: for the treatment of opioid use disorder;
p.000913: (C) to the caregiver or a close relative of patients at an elevated risk of overdose from opioids; or
p.000913: (D) in other circumstances in which a provider identi- fies a patient is at an elevated risk for an
p.000913: intentional or unintentional drug overdose from heroin or prescription opioid therapies.
p.000913: (b) APPLICATION.—To be eligible to receive a grant under this section, an eligible entity shall submit
p.000913: to the Secretary, in such form and manner as specified by the Secretary, an application that describes—
p.000913: (1) the extent to which the area to which the entity will furnish services through use of the grant
p.000913: is experiencing sig- nificant morbidity and mortality caused by opioid abuse;
p.000913: (2) the criteria that will be used to identify eligible pa- tients to participate in such program; and
p.000913: (3) a plan for sustaining the program after Federal support for the program has ended.
p.000913: (c) USE OF FUNDS.—An eligible entity receiving a grant under this section may use amounts under the
p.000913: grant for any of the fol- lowing activities, but may use not more than 20 percent of the grant funds
p.000913: for activities described in paragraphs (3) and (4):
p.000913: (1) To establish a program for prescribing a drug or device approved or cleared under the Federal Food, Drug,
p.000913: and Cos- metic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (2) To train and provide resources for health care providers and pharmacists on the prescribing of drugs or
p.000913: devices ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose.
p.000913: (3) To purchase drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000913: treat- ment of known or suspected opioid overdose, for distribution under the program described in paragraph
p.000913: (1).
p.000913: (4) To offset the co-payments and other cost sharing associ- ated with drugs or devices approved or cleared under the
p.000913: Fed- eral Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (5) To establish protocols to connect patients who have ex- perienced a drug overdose with appropriate treatment,
p.000913: includ-
p.000913: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000913: Sec. 545 PUBLIC HEALTH SERVICE ACT 914
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p.000913: ing medication-assisted treatment and appropriate counseling and behavioral therapies.
p.000913: (d) EVALUATIONS BY RECIPIENTS.—As a condition of receipt of a grant under this section, an eligible
p.000913: entity shall, for each year for which the grant is received, submit to the Secretary an evaluation of activities
p.000913: funded by the grant which contains such information as the Secretary may reasonably require.
p.000913: (e) REPORTS BY THE SECRETARY.—Not later than 5 years after the date on which the first grant under this
p.000913: section is awarded, the Secretary shall submit to the appropriate committees of the House of Representatives and of
p.000913: the Senate a report aggregating the in- formation received from the grant recipients for such year under
p.000913: subsection (d) and evaluating the outcomes achieved by the pro- grams funded by grants awarded under this
p.000913: section.
p.000913: (f) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section, $5,000,000 for
p.000913: the period of fiscal years 2017 through 2021.
p.000913: SEC. 545. ø290ee¿ OPIOID OVERDOSE REVERSAL MEDICATION ACCESS AND EDUCATION GRANT PROGRAMS.
p.000913: (a) GRANTS TO STATES.—The Secretary shall make grants to States to—
p.000913: (1) implement strategies for pharmacists to dispense a drug or device approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, as
p.000913: appropriate, pursuant to a stand- ing order;
p.000913: (2) encourage pharmacies to dispense opioid overdose re- versal medication pursuant to a standing order;
p.000913: (3) develop or provide training materials that persons au- thorized to prescribe or dispense a drug or device
p.000913: approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000913: suspected opioid overdose may use to educate the public concerning—
p.000913: (A) when and how to safely administer such drug or device; and
p.000913: (B) steps to be taken after administering such drug or device; and
p.000913: (4) educate the public concerning the availability of drugs or devices approved or cleared under the
p.000913: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose without
p.000913: a person-specific prescription.
p.000913: (b) CERTAIN REQUIREMENT.—A grant may be made under this section only if the State involved has authorized
p.000913: standing orders to be issued for drugs or devices approved or cleared under the Fed- eral Food, Drug, and
p.000913: Cosmetic Act for emergency treatment of known or suspected opioid overdose.
p.000913: (c) PREFERENCE IN MAKING GRANTS.—In making grants under this section, the Secretary may give preference to States
p.000913: that have a significantly higher rate of opioid overdoses than the national av- erage, and that—
p.000913: (1) have not implemented standing orders regarding drugs or devices approved or cleared under the Federal Food,
p.000913: Drug, and Cosmetic Act for emergency treatment of known or sus- pected opioid overdose;
p.000913: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: 915
p.000915: PUBLIC HEALTH SERVICE ACT
p.000915: Sec. 546
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p.000915: (2) authorize standing orders to be issued that permit com- munity-based organizations, substance abuse
p.000915: programs, or other nonprofit entities to acquire, dispense, or administer drugs or devices approved or
p.000915: cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected
p.000915: opioid overdose; or
p.000915: (3) authorize standing orders to be issued that permit po- lice, fire, or emergency medical services
p.000915: agencies to acquire and administer drugs or devices approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose.
p.000915: (d) GRANT TERMS.—
p.000915: (1) NUMBER.—A State may not receive more than one grant under this section at a time.
p.000915: (2) PERIOD.—A grant under this section shall be for a pe- riod of 3 years.
p.000915: (3) LIMITATION.—A State may use not more than 20 per- cent of a grant under this section for educating the
p.000915: public pur- suant to subsection (a)(4).
p.000915: (e) APPLICATIONS.—To be eligible to receive a grant under this section, a State shall submit an application to
p.000915: the Secretary in such form and manner and containing such information as the Sec- retary may reasonably require,
p.000915: including detailed proposed expend- itures of grant funds.
p.000915: (f) REPORTING.—A State that receives a grant under this sec- tion shall, at least annually for the
p.000915: duration of the grant, submit a report to the Secretary evaluating the progress of the activities
p.000915: supported through the grant. Such reports shall include informa- tion on the number of pharmacies in the State
p.000915: that dispense a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for
p.000915: emergency treatment of known or suspected opioid overdose under a standing order, and other
p.000915: information as the Secretary determines appropriate to evaluate the use of grant funds.
p.000915: (g) DEFINITIONS.—In this section the term ‘‘standing order’’ means a document prepared by a person
p.000915: authorized to prescribe medication that permits another person to acquire, dispense, or ad- minister medication
p.000915: without a person-specific prescription.
p.000915: (h) AUTHORIZATION OF APPROPRIATIONS.—
p.000915: (1) IN GENERAL.—To carry out this section, there are au- thorized to be appropriated $5,000,000 for the
p.000915: period of fiscal years 2017 through 2019.
p.000915: (2) ADMINISTRATIVE COSTS.—Not more than 3 percent of the amounts made available to carry out this
p.000915: section may be used by the Secretary for administrative expenses of carrying out this section.
p.000915: SEC. 546. ø290ee–1¿ FIRST RESPONDER TRAINING.
p.000915: (a) PROGRAM AUTHORIZED.—The Secretary shall make grants to States, local governmental entities, and Indian
p.000915: tribes and tribal organizations (as defined in section 4 of the Indian Self-Determina- tion and Education Assistance
p.000915: Act) to allow first responders and members of other key community sectors to administer a drug or
p.000915: device approved or cleared under the Federal Food, Drug, and Cos-
p.000915: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000915: Sec. 546 PUBLIC HEALTH SERVICE ACT 916
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p.000915: metic Act for emergency treatment of known or suspected opioid overdose.
p.000915: (b) APPLICATION.—
p.000915: (1) IN GENERAL.—An entity seeking a grant under this sec- tion shall submit an application to the Secretary—
p.000915: (A) that meets the criteria under paragraph (2); and
p.000915: (B) at such time, in such manner, and accompanied by such information as the Secretary may require.
p.000915: (2) CRITERIA.—An entity, in submitting an application under paragraph (1), shall—
p.000915: (A) describe the evidence-based methodology and out- come measurements that will be used to evaluate the pro-
p.000915: gram funded with a grant under this section, and specifi- cally explain how such measurements will
p.000915: provide valid measures of the impact of the program;
p.000915: (B) describe how the program could be broadly rep- licated if demonstrated to be effective;
p.000915: (C) identify the governmental and community agencies with which the entity will coordinate to implement the
p.000915: program; and
p.000915: (D) describe how the entity will ensure that law en- forcement agencies will coordinate with
p.000915: their cor- responding State substance abuse and mental health agen- cies to identify protocols and resources
p.000915: that are available to overdose victims and families, including information on treatment and recovery
p.000915: resources.
p.000915: (c) USE OF FUNDS.—An entity shall use a grant received under this section to—
p.000915: (1) make a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency
p.000915: treatment of known or suspected opioid overdose available to be carried and administered by first
p.000915: responders and members of other key community sectors;
p.000915: (2) train and provide resources for first responders and members of other key community sectors on
p.000915: carrying and ad- ministering a drug or device approved or cleared under the Federal Food, Drug, and Cosmetic
p.000915: Act for emergency treatment of known or suspected opioid overdose;
p.000915: (3) establish processes, protocols, and mechanisms for re- ferral to appropriate treatment, which may
p.000915: include an out- reach coordinator or team to connect individuals receiving opioid overdose reversal
p.000915: drugs to followup services; and
p.000915: (4) train and provide resources for first responders and members of other key community sectors on
p.000915: safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs to protect themselves from exposure
p.000915: to such drugs and respond appropriately when exposure occurs.
p.000915: (d) TECHNICAL ASSISTANCE GRANTS.—The Secretary shall make a grant for the purpose of providing technical
p.000915: assistance and train- ing on the use of a drug or device approved or cleared under the Federal Food,
p.000915: Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose, mechanisms for referral to
p.000915: ap- propriate treatment, and safety around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000915: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000917: PUBLIC HEALTH SERVICE ACT
p.000917: Sec. 547
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p.000917: (e) GEOGRAPHIC DISTRIBUTION.—In making grants under this section, the Secretary shall ensure that not less than
p.000917: 20 percent of grant funds are awarded to eligible entities that are not located in metropolitan statistical areas
p.000917: (as defined by the Office of Manage- ment and Budget). The Secretary shall take into account
p.000917: the unique needs of rural communities, including communities with an incidence of individuals with opioid use
p.000917: disorder that is above the national average and communities with a shortage of prevention and treatment
p.000917: services.
p.000917: (f) EVALUATION.—The Secretary shall conduct an evaluation of grants made under this section to determine—
p.000917: (1) the number of first responders and members of other key community sectors equipped with a drug or
p.000917: device ap- proved or cleared under the Federal Food, Drug, and Cosmetic Act for emergency treatment of known or
p.000917: suspected opioid overdose;
p.000917: (2) the number of opioid and heroin overdoses reversed by first responders and members of other key community
p.000917: sectors receiving training and supplies of a drug or device approved or cleared under the Federal Food, Drug, and
p.000917: Cosmetic Act for emergency treatment of known or suspected opioid overdose, through a grant received under
p.000917: this section;
p.000917: (3) the number of responses to requests for services by the entity or subgrantee, to opioid and heroin overdose;
p.000917: (4) the extent to which overdose victims and families re- ceive information about treatment services and
p.000917: available data describing treatment admissions; and
p.000917: (5) the number of first responders and members of other key community sectors trained on safety
p.000917: around fentanyl, carfentanil, and other dangerous licit and illicit drugs.
p.000917: (g) OTHER KEY COMMUNITY SECTORS.—In this section, the term ‘‘other key community sectors’’ includes substance use
p.000917: disorder treatment providers, emergency medical services agencies, agencies and organizations working with prison and
p.000917: jail populations and of- fender reentry programs, health care providers, harm reduction groups, pharmacies,
p.000917: community health centers, tribal health facili- ties, and mental health providers.
p.000917: (h) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000917: $36,000,000 for each of fiscal years 2019 through 2023.
p.000917: SEC. 547. ø290ee–2¿ BUILDING COMMUNITIES OF RECOVERY.
p.000917: (a) DEFINITION.—In this section, the term ‘‘recovery community organization’’ means an independent nonprofit
p.000917: organization that—
p.000917: (1) mobilizes resources within and outside of the recovery community, which may include through a peer
p.000917: support net- work, to increase the prevalence and quality of long-term re- covery from substance use
p.000917: disorders; and
p.000917: (2) is wholly or principally governed by people in recovery for substance use disorders who reflect the community
p.000917: served.
p.000917: (b) GRANTS AUTHORIZED.—The Secretary shall award grants to recovery community organizations to enable such
p.000917: organizations to develop, expand, and enhance recovery services.
p.000917: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000919: networks.
p.000919: (d) RECOVERY COMMUNITY ORGANIZATION.—In this section, the term ‘‘recovery community organization’’ has the
p.000919: meaning given such term in section 547.
p.000919: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000919: $1,000,000 for each of fiscal years 2019 through 2023.
p.000919: SEC. 548. ø290ee–3¿ STATE DEMONSTRATION GRANTS FOR COM- PREHENSIVE OPIOID ABUSE RESPONSE.
p.000919: (a) DEFINITIONS.—In this section:
p.000919: (1) DISPENSER.—The term ‘‘dispenser’’ has the meaning given the term in section 102 of the Controlled Substances
p.000919: Act (21 U.S.C. 802).
p.000919: (2) PRESCRIBER.—The term ‘‘prescriber’’ means a dispenser who prescribes a controlled substance, or the agent
p.000919: of such a dispenser.
p.000919: (3) PRESCRIBER OF A SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘prescriber of a schedule
p.000919: II, III, or IV controlled substance’’ does not include a prescriber of a sched- ule II, III, or IV controlled
p.000919: substance that dispenses the sub- stance—
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p.000919: January 30, 2020
p.000919: (A) for use on the premises on which the substance is dispensed;
p.000919: (B) in a hospital emergency room, when the substance is in short supply;
p.000919: (C) for a certified opioid treatment program; or
p.000919: (D) in other situations as the Secretary may reason- ably determine.
p.000919: (4) SCHEDULE II, III, OR IV CONTROLLED SUBSTANCE.—The term ‘‘schedule II, III, or IV controlled substance’’
p.000919: means a con- trolled substance that is listed on schedule II, schedule III, or schedule IV of section 202(c)
p.000919: of the Controlled Substances Act.
p.000919: (b) GRANTS FOR COMPREHENSIVE OPIOID ABUSE RESPONSE.—
p.000919: (1) IN GENERAL.—The Secretary shall award grants to States, and combinations of States, to implement an
p.000919: integrated opioid abuse response initiative.
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000919:
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p.000919: Sec. 548 PUBLIC HEALTH SERVICE ACT 920
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p.000919: under paragraph (2).
p.000919: (5) PRIORITY CONSIDERATIONS.—In awarding grants under this section, the Secretary shall, as appropriate,
p.000919: give priority to a State that—
p.000919: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000921: 921
p.000921: PUBLIC HEALTH SERVICE ACT
p.000921: Sec. 548
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p.000921: January 30, 2020
p.000921: (A)(i) provides civil liability protection for first re- sponders, health professionals, and family members
p.000921: who have received appropriate training in administering a drug or device approved or cleared under the Federal
p.000921: Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (ii) submits to the Secretary a certification by the at- torney general of the State that the attorney general
p.000921: has—
p.000921: (I) reviewed any applicable civil liability protec- tion law to determine the applicability of the law with
p.000921: respect to first responders, health care professionals, family members, and other individuals who—
p.000921: (aa) have received appropriate training in ad- ministering a drug or device approved or cleared under the
p.000921: Federal Food, Drug, and Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (bb) may administer a drug or device ap- proved or cleared under the Federal Food, Drug, and
p.000921: Cosmetic Act for emergency treatment of known or suspected opioid overdose; and
p.000921: (II) concluded that the law described in subclause
p.000921: (I) provides adequate civil liability protection applica- ble to such persons;
p.000921: (B) has a process for enrollment in services and bene- fits necessary by criminal justice agencies to initiate
p.000921: or continue treatment in the community, under which an in- dividual who is incarcerated may, while
p.000921: incarcerated, en- roll in services and benefits that are necessary for the indi- vidual to continue treatment upon
p.000921: release from incarcer- ation;
p.000921: (C) ensures the capability of data sharing with other States, where applicable, such as by making data
p.000921: available to a prescription monitoring hub;
p.000921: (D) ensures that data recorded in the prescription drug monitoring program database of the State are
p.000921: regu- larly updated, to the extent possible;
p.000921: (E) ensures that the prescription drug monitoring pro- gram of the State notifies prescribers and dispensers of
p.000921: schedule II, III, or IV controlled substances when overuse or misuse of such controlled substances by patients
p.000921: is sus- pected; and
p.000921: (F) has in effect one or more statutes or implements policies that maximize use of prescription drug
...

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p.000931: Sec. 562 PUBLIC HEALTH SERVICE ACT 932
p.000931:
p.000931: ices, educational services, child welfare services, or juvenile justice services.
p.000931: (b) LIMITATION ON AGE OF CHILDREN PROVIDED ACCESS TO SYS- TEM.—A funding agreement for a grant under section
p.000931: 561(a) is that a system of care under subsection (a) will provide an individual with access to the system
p.000931: through the age of 21 years.
p.000931: (c) REQUIRED MENTAL HEALTH SERVICES OF SYSTEM.—A fund- ing agreement for a grant under section 561(a) is
p.000931: that mental health services provided by a system of care under subsection (a) will include, with respect
p.000931: to a serious emotional disturbance in a child—
p.000931: (1) diagnostic and evaluation services;
p.000931: (2) outpatient services provided in a clinic, office, school or other appropriate location, including
p.000931: individual, group and family counseling services, professional consultation, and re- view and management of
p.000931: medications;
p.000931: (3) emergency services, available 24-hours a day, 7 days a week;
p.000931: (4) intensive home-based services for children and their families when the child is at imminent risk of
p.000931: out-of-home placement;
p.000931: (5) intensive day-treatment services;
p.000931: (6) respite care;
p.000931: (7) therapeutic foster care services, and services in thera- peutic foster family homes or individual
p.000931: therapeutic residential homes, and groups homes caring for not more than 10 children; and
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p.000931: January 30, 2020
p.000931: (8) assisting the child in making the transition from the services received as a child to the services to be
p.000931: received as an adult.
p.000931: (d) REQUIRED ARRANGEMENTS REGARDING OTHER APPROPRIATE SERVICES.—
p.000931: (1) IN GENERAL.—A funding agreement for a grant under section 561(a) is that—
p.000931: (A) a system of care under subsection (a) will enter into a memorandum of understanding with each of
p.000931: the providers specified in paragraph (2) in order to facilitate the availability of the services of the
...

p.000941: (a) IN GENERAL.—A public or private general hospital, nursing facility, intermediate care facility, or other health
p.000941: care facility, that receives support in any form from any program supported in whole or in part with funds
p.000941: appropriated to any Federal department or agency shall protect and promote the rights of each resident of the
p.000941: facility, including the right to be free from physical or mental abuse, corporal punishment, and any
p.000941: restraints or involuntary se- clusions imposed for purposes of discipline or convenience.
p.000941: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000941:
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p.000941: Sec. 592 PUBLIC HEALTH SERVICE ACT 942
p.000941:
p.000941: (b) REQUIREMENTS.—Restraints and seclusion may only be im- posed on a resident of a facility described in subsection
p.000941: (a) if—
p.000941: (1) the restraints or seclusion are imposed to ensure the physical safety of the resident, a staff
p.000941: member, or others; and
p.000941: (2) the restraints or seclusion are imposed only upon the written order of a physician, or other licensed
p.000941: practitioner per- mitted by the State and the facility to order such restraint or seclusion, that specifies
p.000941: the duration and circumstances under which the restraints are to be used (except in emergency cir- cumstances
p.000941: specified by the Secretary until such an order could reasonably be obtained).
p.000941: (c) CURRENT LAW.—This part shall not be construed to affect or impede any Federal or State law or
p.000941: regulations that provide greater protections than this part regarding seclusion and re- straint.
p.000941: (d) DEFINITIONS.—In this section:
p.000941: (1) RESTRAINTS.—The term ‘‘restraints’’ means—
p.000941: (A) any physical restraint that is a mechanical or per- sonal restriction that immobilizes or reduces the ability of an
p.000941: individual to move his or her arms, legs, or head freely, not including devices, such as orthopedically prescribed de-
p.000941: vices, surgical dressings or bandages, protective helmets, or any other methods that involves the physical
p.000941: holding of a resident for the purpose of conducting routine physical examinations or tests or to protect
p.000941: the resident from fall- ing out of bed or to permit the resident to participate in activities without the
p.000941: risk of physical harm to the resident (such term does not include a physical escort); and
p.000941: (B) a drug or medication that is used as a restraint to control behavior or restrict the resident’s freedom of move-
p.000941: ment that is not a standard treatment for the resident’s medical or psychiatric condition.
p.000941: (2) SECLUSION.—The term ‘‘seclusion’’ means a behavior control technique involving locked isolation. Such
p.000941: term does not include a time out.
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p.000943: January 30, 2020
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p.000943: in any form from any program supported in whole or in part with funds appropriated under this Act
p.000943: shall protect and pro- mote the rights of each resident of the facility, including the right to be free
p.000943: from physical or mental abuse, corporal punish- ment, and any restraints or involuntary seclusions imposed for purposes
p.000943: of discipline or convenience.
p.000943: (2) NONAPPLICABILITY.—Notwithstanding this part, a facil- ity that provides inpatient psychiatric treatment
p.000943: services for individuals under the age of 21, as authorized and defined in subsections (a)(16) and (h)
p.000943: of section 1905 of the Social Secu- rity Act, shall comply with the requirements of part H.
p.000943: (3) APPLICABILITY OF MEDICAID PROVISIONS.—A non-med- ical, community-based facility for children and
p.000943: youth funded under the Medicaid program under title XIX of the Social Secu- rity Act shall continue to meet all
p.000943: existing requirements for participation in such program that are not affected by this part.
p.000943: (b) REQUIREMENTS.—
p.000943: (1) IN GENERAL.—Physical restraints and seclusion may only be imposed on a resident of a facility
p.000943: described in sub- section (a) if—
p.000943: (A) the restraints or seclusion are imposed only in emergency circumstances and only to ensure the imme-
p.000943: diate physical safety of the resident, a staff member, or others and less restrictive interventions have
p.000943: been deter- mined to be ineffective; and
p.000943: (B) the restraints or seclusion are imposed only by an individual trained and certified, by a State-recognized body (as
p.000943: defined in regulation promulgated by the Secretary) and pursuant to a process determined appropriate by
p.000943: the State and approved by the Secretary, in the prevention and use of physical restraint and seclusion,
p.000943: including the needs and behaviors of the population served, relationship building, alternatives to restraint and
p.000943: seclusion, de-esca- lation methods, avoiding power struggles, thresholds for restraints and seclusion, the
p.000943: physiological and psycho- logical impact of restraint and seclusion, monitoring phys- ical signs of distress
p.000943: and obtaining medical assistance, legal issues, position asphyxia, escape and evasion tech- niques, time
p.000943: limits, the process for obtaining approval for continued restraints, procedures to address problematic re-
p.000943: straints, documentation, processing with children, and fol- low-up with staff, and investigation of injuries and
p.000943: com- plaints.
p.000943: (2) INTERIM PROCEDURES RELATING TO TRAINING AND CER- TIFICATION.—
p.000943: (A) IN GENERAL.—Until such time as the State devel- ops a process to assure the proper training and
p.000943: certifi- cation of facility personnel in the skills and competencies referred in paragraph (1)(B), the facility
p.000943: involved shall de- velop and implement an interim procedure that meets the requirements of subparagraph (B).
...

p.000971: of any other loss incurred by the Secretary by reason of the failure of such public agency to make payments of
p.000971: principal and interest on such loan, the Secretary shall be subrogated to all rights of such purchaser for
p.000971: recovery of such loss from such public agen- cy.
p.000971: (d) The Secretary may, for good cause, waive any right of re- covery which he has against a public agency by
p.000971: reason of the fail- ure of such agency to make payments of principal and interest on a loan made to such
p.000971: agency under this part.
p.000971: (e) After any loan to a public agency under this part has been sold and guaranteed, interest paid on such loan
p.000971: and any interest subsidy paid by the Secretary with respect to such loan which is received by the
p.000971: purchaser thereof (or his successor in interest) shall be included in gross income for the purposes of chapter 1 of the
p.000971: In- ternal Revenue Code of 1954.
p.000971: (f) Amounts received by the Secretary as proceeds from the sale of loans under this section shall be deposited
p.000971: in the loan fund established by section 626, and shall be available to the Secretary for the making of
p.000971: further loans under this part in accordance with the provisions of subsection (a)(2) of such section.
p.000971: (g) There is authorized to be appropriated to the Secretary, for deposit in the loan fund established by section 626,
p.000971: $30,000,000 to provide initial capital for the making of direct loans by the Sec- retary to public
p.000971: agencies for the modernization or construction of facilities referred to in subsection (a)(1).
p.000971: PART C—CONSTRUCTION OR MODERNIZATION OF EMERGENCY ROOMS
p.000971: AUTHORIZATION
p.000971: SEC. 631. ø291j–8¿ In order to assist in the provision of ade- quate emergency room service in various
p.000971: communities of the Na- tion for treatment of accident victims and handling of other med- ical emergencies
p.000971: through special project grants for the construction or modernization of emergency rooms of general hospitals,
p.000971: there are authorized to be appropriated $20,000,000 each for the fiscal year ending June 30, 1971, and the
p.000971: next two fiscal years.
p.000971:
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p.000971: January 30, 2020
p.000971: ELIGIBILITY FOR GRANTS
p.000971: SEC. 632. ø291j–9¿ Funds appropriated pursuant to section 631 shall be available for grants by the Secretary
p.000971: for not to exceed 50 per centum of the cost of construction or modernization of emer- gency rooms of
p.000971: public or nonprofit general hospitals, including pro-
p.000971: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000971:
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p.000971: Sec. 633 PUBLIC HEALTH SERVICE ACT 972
p.000971:
p.000971: vision or replacement of medical transportation facilities. Such grants shall be made by the Secretary only
p.000971: after consultation with the State agency designated in accordance with section 604(a)(1) of the Public Health
p.000971: Service Act. In order to be eligible for a grant under this part, the project, and the applicant therefor,
p.000971: must meet such criteria as may be prescribed by regulations. Such regulations shall be so designed as to provide aid
p.000971: only with respect to projects for which adequate assistance is not readily available from other Federal,
p.000971: State, local, or other sources, and to assist in providing modern, efficient, and effective emergency
p.000971: room service needed to care for victims of highway, industrial, agricultural, or other acci- dents and to
p.000971: handle other medical emergencies, and to assist in providing such service in geographical areas which
p.000971: have special need therefor.
p.000971: PAYMENTS
p.000971: SEC. 633. ø291j–10¿ Grants under this part shall be paid in advance or by way of reimbursement, in such
p.000971: installments and on such conditions, as in the judgment of the Secretary will best carry out the purposes of this part.
p.000971: PART D—GENERAL
p.000971:
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p.000971: January 30, 2020
p.000971:
p.000971: FEDERAL HOSPITAL COUNCIL AND ADVISORY COMMITTEES
p.000971: SEC. 641. ø291k¿ (a) In administering this title, the Surgeon General shall consult with a Federal Hospital
p.000971: Council consisting of the Surgeon General, who shall serve as Chairman ex officio, and twelve members
p.000971: appointed by the Secretary of Health, Education, and Welfare. Six of the twelve appointed members shall be
p.000971: persons who are outstanding in fields pertaining to medical facility and health activities, and three of these
p.000971: six shall be authorities in mat- ters relating to the operation of hospitals or other medical facilities, one of them
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p.001145: create a high risk of medication-related problems.
p.001145: (e) CONSULTATION WITH EXPERTS.—In designing and imple- menting MTM services provided under grants or contracts
p.001145: awarded under subsection (a), the Secretary shall consult with Federal, State, private, public-private, and
p.001145: academic entities, pharmacy and pharmacist organizations, health care organizations, consumer ad- vocates,
p.001145: chronic disease groups, and other stakeholders involved with the research, dissemination, and implementation
p.001145: of phar- macist-delivered MTM services, as the Secretary determines appro- priate. The Secretary, in collaboration
p.001145: with this group, shall deter- mine whether it is possible to incorporate rapid cycle process im- provement
p.001145: concepts in use in other Federal programs that have im- plemented MTM services.
p.001145: (f) REPORTING TO THE SECRETARY.—An entity that receives a grant or contract under subsection (a) shall submit
p.001145: to the Secretary a report that describes and evaluates, as requested by the Sec- retary, the activities
p.001145: carried out under subsection (c), including quality measures endorsed by the entity with a contract under sec-
p.001145: tion 1890 of the Social Security Act, as determined by the Sec- retary.
p.001145: (g) EVALUATION AND REPORT.—The Secretary shall submit to the relevant committees of Congress a report which
p.001145: shall—
p.001145: (1) assess the clinical effectiveness of pharmacist-provided services under the MTM services program, as
p.001145: compared to usual care, including an evaluation of whether enrollees main- tained better health with fewer
p.001145: hospitalizations and emergency room visits than similar patients not enrolled in the program;
p.001145: (2) assess changes in overall health care resource use by targeted individuals;
p.001145: (3) assess patient and prescriber satisfaction with MTM services;
p.001145: (4) assess the impact of patient-cost sharing requirements on medication adherence and recommendations for
p.001145: modifica- tions;
p.001145: (5) identify and evaluate other factors that may impact clinical and economic outcomes, including demographic
p.001145: charac- teristics, clinical characteristics, and health services use of the patient, as well as characteristics of
p.001145: the regimen, pharmacy benefit, and MTM services provided; and
p.001145: (6) evaluate the extent to which participating pharmacists who maintain a dispensing role have a conflict of
p.001145: interest in the provision of MTM services, and if such conflict is found, provide recommendations on how
p.001145: such a conflict might be ap- propriately addressed.
p.001145: (h) GRANTS OR CONTRACTS TO FUND DEVELOPMENT OF PER- FORMANCE MEASURES.—The Secretary may, through
p.001145: the quality measure development program under section 931 of the Public Health Service Act, award grants or
p.001145: contracts to eligible entities for the purpose of funding the development of performance measures that assess
p.001145: the use and effectiveness of medication therapy man- agement services.
p.001145: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001145:
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p.001165: in sickle cell disease at tertiary and academic health centers and State and county health offices.
p.001165: (D) To identify and secure resources for ensuring reim- bursement under the medicaid program, State children’s
p.001165: health insurance program, and other health programs for the prevention and treatment of sickle cell disease.
p.001165: (E) To provide or coordinate services for adolescents with sickle cell disease making the transition to
p.001165: adult health care.
p.001165: (3) NATIONAL COORDINATING CENTER.—
p.001165: (A) ESTABLISHMENT.—The Administrator shall enter into a contract with an entity to serve as the National Co-
p.001165: ordinating Center for the demonstration program con- ducted under this subsection.
p.001165: (B) ACTIVITIES DESCRIBED.—The National Coordi- nating Center shall—
p.001165: (i) collect, coordinate, monitor, and distribute data, best practices, and findings regarding the activi-
p.001165: ties funded under grants made to eligible entities under the demonstration program;
p.001165: (ii) develop a model protocol for eligible entities with respect to the prevention and treatment of sickle cell
p.001165: disease;
p.001165: (iii) develop educational materials regarding the prevention and treatment of sickle cell disease; and
p.001165: (iv) prepare and submit to Congress a final report that includes recommendations regarding the effec- tiveness
p.001165: of the demonstration program conducted under this subsection and such direct outcome meas- ures as—
p.001165: (I) the number and type of health care re- sources utilized (such as emergency room visits, hospital
p.001165: visits, length of stay, and physician visits for individuals with sickle cell disease); and
p.001165: (II) the number of individuals that were test- ed and subsequently received genetic counseling for the
p.001165: sickle cell trait.
p.001165: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001165:
p.001165:
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p.001167: PUBLIC HEALTH SERVICE ACT
p.001167: Sec. 1107
p.001167:
p.001167: (4) APPLICATION.—An eligible entity desiring a grant under this subsection shall submit an application to the
p.001167: Adminis- trator at such time, in such manner, and containing such infor- mation as the Administrator may require.
p.001167: (5) DEFINITIONS.—In this subsection:
p.001167: (A) ADMINISTRATOR.—The term ‘‘Administrator’’ means the Administrator of the Health Resources and Services
p.001167: Administration.
p.001167: (B) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a Federally-qualified health center, a nonprofit hos-
p.001167: pital or clinic, or a university health center that provides primary health care, that—
p.001167: (i) has a collaborative agreement with a commu- nity-based sickle cell disease organization or a non-
p.001167: profit entity with experience in working with individ- uals who have sickle cell disease; and
p.001167: (ii) demonstrates to the Administrator that either the Federally-qualified health center, the nonprofit
p.001167: hospital or clinic, the university health center, the or- ganization or entity described in clause (i), or the
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p.001175: for Disease Con- trol and Prevention, the Administrator of the Health Resources and Services Administration, the
p.001175: Director of the Agency for Healthcare Research and Quality, the Commissioner of Food and Drugs, and the
p.001175: Director of the National Institutes of Health, or their designees.
p.001175: (d) ACTIVITIES.—The Interagency Coordinating Committee shall—
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p.001175: (1) report to the Secretary and the appropriate committees of Congress on its recommendations related to the purpose
p.001175: de- scribed in subsection (a); and
p.001175: (2) carry out other activities determined appropriate by the Secretary.
p.001175: SEC. 1115. ø300b–14¿ NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
p.001175: (a) IN GENERAL.—Not later than 180 days after the date of en- actment of this section, the Secretary, acting
p.001175: through the Director of the Centers for Disease Control and Prevention and in consulta- tion with the Administrator
p.001175: and State departments of health (or re- lated agencies), shall develop a national contingency plan for new- born
p.001175: screening for use by a State, region, or consortium of States in the event of a public health
p.001175: emergency. The plan shall be up- dated as needed and at least every five years.
p.001175: (b) CONTENTS.—The contingency plan developed under sub- section (a) shall include a plan for—
p.001175: (1) the collection and transport of specimens;
p.001175: (2) the shipment of specimens to State newborn screening laboratories;
p.001175: (3) the processing of specimens;
p.001175: (4) the reporting of screening results to physicians and families;
p.001175: (5) the diagnostic confirmation of positive screening re- sults;
p.001175: (6) ensuring the availability of treatment and management resources;
p.001175: (7) educating families about newborn screening; and
p.001175: (8) carrying out other activities determined appropriate by the Secretary.
p.001175: SEC. 1116. ø300b–15¿ HUNTER KELLY RESEARCH PROGRAM.
p.001175: (a) NEWBORN SCREENING ACTIVITIES.—
p.001175: (1) IN GENERAL.—The Secretary, in conjunction with the Director of the National Institutes of Health and
p.001175: taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating,
p.001175: and expanding re- search in newborn screening (to be known as ‘‘Hunter Kelly Newborn Screening Research
p.001175: Program’’) including—
p.001175: (A) identifying, developing, and testing the most prom- ising new screening technologies, in order to improve
p.001175: al- ready existing screening tests, increase the specificity of newborn screening, and expand the number
p.001175: of conditions for which screening tests are available;
p.001175: (B) experimental treatments and disease management strategies for additional newborn conditions, and other ge-
p.001175: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001175:
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p.001177: to be ap- propriated $4,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977,
p.001177: $3,450,000 for the fiscal year end- ing September 30, 1978, $2,500,000 for the fiscal year ending Sep- tember 30,
p.001177: 1979, $3,000,000 for the fiscal year ending September 30, 1980, $3,500,000 for the fiscal year ending September
p.001177: 30, 1981.
p.001177: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: 1179
p.001179: PUBLIC HEALTH SERVICE ACT
p.001179: Sec. 1202
p.001179:
p.001179: TITLE XII—TRAUMA CARE
p.001179: PART A—GENERAL AUTHORITY AND DUTIES OF SECRETARY
p.001179: SEC. 1201. ø300d¿ ESTABLISHMENT.
p.001179: (a) IN GENERAL.—The Secretary shall, with respect to trauma care—
p.001179: (1) conduct and support research, training, evaluations, and demonstration projects;
p.001179: (2) foster the development of appropriate, modern systems of such care through the sharing of information among
p.001179: agen- cies and individuals involved in the study and provision of such care;
p.001179: (3) collect, compile, and disseminate information on the achievements of, and problems experienced by, State and
p.001179: local agencies and private entities in providing trauma care and emergency medical services and, in so
p.001179: doing, give special con- sideration to the unique needs of rural areas;
p.001179: (4) provide to State and local agencies technical assistance to enhance each State’s capability to develop,
p.001179: implement, and sustain the trauma care component of each State’s plan for the provision of emergency medical services;
p.001179: (5) sponsor workshops and conferences; and
p.001179: (6) promote the collection and categorization of trauma data in a consistent and standardized manner.
p.001179: (b) GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS.—The Secretary may make grants, and enter into cooperative
p.001179: agreements and contracts, for the purpose of carrying out subsection (a).
p.001179: SEC. 1202. ø300d–3¿ ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE IN RURAL AREAS.
p.001179: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001179: of carrying out re- search and demonstration projects with respect to improving the availability and
p.001179: quality of emergency medical services in rural areas—
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p.001179: January 30, 2020
p.001179: (1) by developing innovative uses of communications tech- nologies and the use of new communications technology;
p.001179: (2) by developing model curricula, such as advanced trau- ma life support, for training emergency medical
p.001179: services per- sonnel, including first responders, emergency medical techni- cians, emergency nurses and
p.001179: physicians, and paramedics—
p.001179: (A) in the assessment, stabilization, treatment, prepa- ration for transport, and resuscitation of seriously
p.001179: injured patients, with special attention to problems that arise dur- ing long transports and to methods of
p.001179: minimizing delays in transport to the appropriate facility; and
p.001179: (B) in the management of the operation of the emer- gency medical services system;
p.001179: (3) by making training for original certification, and con- tinuing education, in the provision and
p.001179: management of emer- gency medical services more accessible to emergency medical personnel in rural areas
p.001179: through telecommunications, home studies, providing teachers and training at locations accessible to such personnel,
p.001179: and other methods;
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: Sec. 1203 PUBLIC HEALTH SERVICE ACT 1180
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p.001179: (4) by developing innovative protocols and agreements to increase access to prehospital care and equipment
p.001179: necessary for the transportation of seriously injured patients to the ap- propriate facilities;
p.001179: (5) by evaluating the effectiveness of protocols with respect to emergency medical services and systems; and
p.001179: (6) by increasing communication and coordination with State trauma systems.
p.001179: (b) SPECIAL CONSIDERATION FOR CERTAIN RURAL AREAS.—In making grants under subsection (a), the
p.001179: Secretary shall give spe- cial consideration to any applicant for the grant that will provide services
p.001179: under the grant in any rural area identified by a State under section 1214(d)(1).
p.001179: (c) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.001179: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.001179: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.001179: be nec- essary to carry out this section.
p.001179: SEC. 1203. ø300d–5¿ COMPETITIVE GRANTS FOR TRAUMA SYSTEMS FOR THE IMPROVEMENT OF TRAUMA CARE.
p.001179: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, may
p.001179: make grants to States, political subdivisions, or consortia of States or political sub- divisions for the purpose of
p.001179: improving access to and enhancing the development of trauma care systems.
p.001179: (b) USE OF FUNDS.—The Secretary may make a grant under this section only if the applicant agrees to use the
p.001179: grant—
p.001179: (1) to integrate and broaden the reach of a trauma care system, such as by developing innovative
p.001179: protocols to increase access to prehospital care;
p.001179: (2) to strengthen, develop, and improve an existing trauma care system;
p.001179: (3) to expand communications between the trauma care system and emergency medical services through
p.001179: improved equipment or a telemedicine system;
p.001179: (4) to improve data collection and retention; or
p.001179: (5) to increase education, training, and technical assistance opportunities, such as training and continuing education
p.001179: in the management of emergency medical services accessible to emer- gency medical personnel in rural areas
p.001179: through telehealth, home studies, and other methods.
p.001179: (c) PREFERENCE.—In selecting among States, political subdivi- sions, and consortia of States or political
p.001179: subdivisions for purposes of making grants under this section, the Secretary shall give pref- erence to applicants
p.001179: that—
p.001179: (1) have developed a process, using national standards, for designating trauma centers;
p.001179: (2) recognize protocols for the delivery of seriously injured patients to trauma centers;
p.001179: (3) implement a process for evaluating the performance of the trauma system; and
p.001179: (4) agree to participate in information systems described in section 1202 by collecting, providing, and sharing
p.001179: information.
p.001179: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: 1181
p.001181: PUBLIC HEALTH SERVICE ACT
p.001181: Sec. 1204
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p.001181: January 30, 2020
p.001181: (d) PRIORITY.—In making grants under this section, the Sec- retary shall give priority to applicants that
p.001181: will use the grants to focus on improving access to trauma care systems.
p.001181: (e) SPECIAL CONSIDERATION.—In awarding grants under this section, the Secretary shall give special
p.001181: consideration to projects that demonstrate strong State or local support, including avail- ability of
p.001181: non-Federal contributions.
p.001181: SEC. 1204. ø300d–6¿ COMPETITIVE GRANTS FOR REGIONALIZED SYS- TEMS FOR EMERGENCY CARE RESPONSE.
p.001181: (a) IN GENERAL.—The Secretary, acting through the Assistant Secretary for Preparedness and Response, shall
p.001181: award not fewer than 4 multiyear contracts or competitive grants to eligible entities to support pilot projects that
p.001181: design, implement, and evaluate inno- vative models of regionalized, comprehensive, and accountable
p.001181: emergency care and trauma systems.
p.001181: (b) ELIGIBLE ENTITY; REGION.—In this section:
p.001181: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means—
p.001181: (A) a State or a partnership of 1 or more States and 1 or more local governments; or
p.001181: (B) an Indian tribe (as defined in section 4 of the In- dian Health Care Improvement Act) or a
p.001181: partnership of 1 or more Indian tribes.
p.001181: (2) REGION.—The term ‘‘region’’ means an area within a State, an area that lies within multiple States,
p.001181: or a similar area (such as a multicounty area), as determined by the Sec- retary.
p.001181: (3) EMERGENCY SERVICES.—The term ‘‘emergency services’’ includes acute, prehospital, and trauma care.
p.001181: (c) PILOT PROJECTS.—The Secretary shall award a contract or grant under subsection (a) to an eligible entity
p.001181: that proposes a pilot project to design, implement, and evaluate an emergency medical and trauma system that—
p.001181: (1) coordinates with public health and safety services, emergency medical services, medical facilities,
p.001181: trauma centers, and other entities in a region to develop an approach to emer- gency medical and trauma system
p.001181: access throughout the re- gion, including 9–1–1 Public Safety Answering Points and emergency medical
p.001181: dispatch;
p.001181: (2) includes a mechanism, such as a regional medical di- rection or transport communications system,
p.001181: that operates throughout the region to ensure that the patient is taken to the medically appropriate
p.001181: facility (whether an initial facility or a higher-level facility) in a timely fashion;
p.001181: (3) allows for the tracking of prehospital and hospital re- sources, including inpatient bed capacity,
p.001181: emergency depart- ment capacity, trauma center capacity, on-call specialist cov- erage, ambulance diversion
p.001181: status, and the coordination of such tracking with regional communications and hospital des- tination
p.001181: decisions; and
p.001181: (4) includes a consistent region-wide prehospital, hospital, and interfacility data management system that—
p.001181: (A) submits data to the National EMS Information System, the National Trauma Data Bank, and others;
p.001181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001181: Sec. 1204 PUBLIC HEALTH SERVICE ACT 1182
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p.001181: (B) reports data to appropriate Federal and State databanks and registries; and
p.001181: (C) contains information sufficient to evaluate key ele- ments of prehospital care, hospital destination
p.001181: decisions, including initial hospital and interfacility decisions, and relevant health outcomes of hospital care.
p.001181: (d) APPLICATION.—
p.001181: (1) IN GENERAL.—An eligible entity that seeks a contract or grant described in subsection (a) shall
p.001181: submit to the Sec- retary an application at such time and in such manner as the Secretary may require.
p.001181: (2) APPLICATION INFORMATION.—Each application shall in- clude—
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p.001181: January 30, 2020
p.001181: (A) an assurance from the eligible entity that the pro- posed system—
p.001181: (i) has been coordinated with the applicable State Office of Emergency Medical Services (or equivalent State
p.001181: office);
p.001181: (ii) includes consistent indirect and direct medical oversight of prehospital, hospital, and interfacility
p.001181: transport throughout the region;
p.001181: (iii) coordinates prehospital treatment and triage, hospital destination, and interfacility transport
p.001181: throughout the region;
p.001181: (iv) includes a categorization or designation sys- tem for special medical facilities throughout the region that
p.001181: is integrated with transport and destination pro- tocols;
p.001181: (v) includes a regional medical direction, patient tracking, and resource allocation system that supports
p.001181: day-to-day emergency care and surge capacity and is integrated with other components of the national and
p.001181: State emergency preparedness system; and
p.001181: (vi) addresses pediatric concerns related to inte- gration, planning, preparedness, and coordination of
p.001181: emergency medical services for infants, children and adolescents; and
p.001181: (B) such other information as the Secretary may re- quire.
p.001181: (e) REQUIREMENT OF MATCHING FUNDS.—
p.001181: (1) IN GENERAL.—The Secretary may not make a grant under this section unless the State (or consortia of
p.001181: States) in- volved agrees, with respect to the costs to be incurred by the State (or consortia) in
p.001181: carrying out the purpose for which such grant was made, to make available non-Federal contributions (in cash
p.001181: or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3
p.001181: of Federal funds provided in the grant. Such contributions may be made directly or through donations from
p.001181: public or private entities.
p.001181: (2) NON-FEDERAL CONTRIBUTIONS.—Non-Federal contribu- tions required in paragraph (1) may be in cash or in kind,
p.001181: fair- ly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts
p.001181: provided by the Federal Government, or services assisted or subsidized to any signifi-
p.001181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001183: PUBLIC HEALTH SERVICE ACT
p.001183: Sec. 1212
p.001183:
p.001183: cant extent by the Federal Government, may not be included in determining the amount of such non-Federal
p.001183: contributions.
p.001183: (f) PRIORITY.—The Secretary shall give priority for the award of the contracts or grants described in
p.001183: subsection (a) to any eligible entity that serves a population in a medically underserved area (as defined in section
p.001183: 330(b)(3)).
p.001183: (g) REPORT.—Not later than 90 days after the completion of a pilot project under subsection (a), the
p.001183: recipient of such contract or grant described in shall submit to the Secretary a report containing the results of
p.001183: an evaluation of the program, including an identifica- tion of—
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p.001183: (1) the impact of the regional, accountable emergency care and trauma system on patient health outcomes for various
p.001183: crit- ical care categories, such as trauma, stroke, cardiac emer- gencies, neurological emergencies, and
p.001183: pediatric emergencies;
p.001183: (2) the system characteristics that contribute to the effec- tiveness and efficiency of the program (or lack
p.001183: thereof);
p.001183: (3) methods of assuring the long-term financial sustain- ability of the emergency care and trauma system;
p.001183: (4) the State and local legislation necessary to implement and to maintain the system;
p.001183: (5) the barriers to developing regionalized, accountable emergency care and trauma systems, as well as
p.001183: the methods to overcome such barriers; and
p.001183: (6) recommendations on the utilization of available funding for future regionalization efforts.
p.001183: (h) DISSEMINATION OF FINDINGS.—The Secretary shall, as ap- propriate, disseminate to the public and to
p.001183: the appropriate Com- mittees of the Congress, the information contained in a report made under subsection
p.001183: (g).
p.001183: PART B—FORMULA GRANTS WITH RESPECT TO MODIFICATIONS OF
p.001183: STATE PLANS
p.001183: SEC. 1211. ø300d–11¿ ESTABLISHMENT OF PROGRAM.
p.001183: (a) REQUIREMENT OF ALLOTMENTS FOR STATES.—The Secretary shall for each fiscal year make an allotment for
p.001183: each State in an amount determined in accordance with section 1218. The Secretary shall make payments, as grants,
p.001183: each fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal
p.001183: year involved an application submitted by the State pursuant to section 1217.
p.001183: (b) PURPOSE.—Except as provided in section 1233, the Sec- retary may not make payments under this part for a
p.001183: fiscal year un- less the State involved agrees that, with respect to the trauma care component of the State plan for
p.001183: the provision of emergency medical services, the payments will be expended only for the purpose of de- veloping,
p.001183: implementing, and monitoring the modifications to such component described in section 1213.
p.001183: SEC. 1212. ø300d–12¿ REQUIREMENT OF MATCHING FUNDS FOR FISCAL YEARS SUBSEQUENT TO FIRST FISCAL YEAR OF
p.001183: PAY- MENTS.
p.001183: (a) NON-FEDERAL CONTRIBUTIONS.—
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p.001183: Sec. 1213 PUBLIC HEALTH SERVICE ACT 1184
p.001183: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) unless the State involved
p.001183: agrees, with respect to the costs described in paragraph (2), to make avail- able non-Federal contributions (in
p.001183: cash or in kind under sub- section (b)(1)) toward such costs in an amount that—
p.001183: (A) for the second and third fiscal years of such pay- ments to the State, is not less than $1 for each $1 of
p.001183: Fed- eral funds provided in such payments for such fiscal years; and
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p.001183: (B) for the fourth and subsequent fiscal years of such payments to the State, is not less than $2 for
p.001183: each $1 of Federal funds provided in such payments for such fiscal years.
p.001183: (2) PROGRAM COSTS.—The costs referred to in paragraph
p.001183: (1) are—
p.001183: (A) the costs to be incurred by the State in carrying out the purpose described in section 1211(b); or
p.001183: (B) the costs of improving the quality and availability of emergency medical services in rural areas of the
p.001183: State.
p.001183: (3) INITIAL YEAR OF PAYMENTS.—The Secretary may not re- quire a State to make non-Federal contributions as a condition
p.001183: of receiving payments under section 1211(a) for the first fiscal year of such payments to the State.
p.001183: (b) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBU- TION.—With respect to compliance with subsection
p.001183: (a) as a condi- tion of receiving payments under section 1211(a)—
p.001183: (1) a State may make the non-Federal contributions re- quired in such subsection in cash or in kind,
p.001183: fairly evaluated, including plant, equipment, or services; and
p.001183: (2) the Secretary may not, in making a determination of the amount of non-Federal contributions, include
p.001183: amounts pro- vided by the Federal Government or services assisted or sub- sidized to any significant extent by
p.001183: the Federal Government.
p.001183: SEC. 1213. ø300d–13¿ REQUIREMENTS WITH RESPECT TO CARRYING OUT PURPOSE OF ALLOTMENTS.
p.001183: (a) TRAUMA CARE MODIFICATIONS TO STATE PLAN FOR EMER- GENCY MEDICAL SERVICES.—With respect to the trauma
p.001183: care com- ponent of a State plan for the provision of emergency medical serv- ices, the modifications referred to in
p.001183: section 1211(b) are such modi- fications to the State plan as may be necessary for the State in- volved to
p.001183: ensure that the plan provides for access to the highest possible quality of trauma care, and that the plan—
p.001183: (1) specifies that the modifications required pursuant to paragraphs (2) through (11) will be implemented
p.001183: by the prin- cipal State agency with respect to emergency medical services or by the designee of such agency;
p.001183: (2) specifies a public or private entity that will designate trauma care regions and trauma centers in the
p.001183: State;
p.001183: (3) subject to subsection (b), contains national standards and requirements of the American College of
p.001183: Surgeons or an- other appropriate entity for the designation of level I and level II trauma centers, and in the case
p.001183: of rural areas level III trau- ma centers (including trauma centers with specified capabili-
p.001183: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001185: 1185
p.001185: PUBLIC HEALTH SERVICE ACT
p.001185: Sec. 1213
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p.001185: ties and expertise in the care of pediatric trauma patients), by such entity, including standards and requirements for—
p.001185: (A) the number and types of trauma patients for whom such centers must provide care in order to ensure that
p.001185: such centers will have sufficient experience and expertise to be able to provide quality care for victims of
p.001185: injury;
p.001185: (B) the resources and equipment needed by such cen- ters; and
p.001185: (C) the availability of rehabilitation services for trau- ma patients;
p.001185: (4) contains standards and requirements for the implemen- tation of regional trauma care systems, including
p.001185: standards and guidelines (consistent with the provisions of section 1867 of the Social Security Act) for
p.001185: medically directed triage and transportation of trauma patients (including patients injured in rural areas)
p.001185: prior to care in designated trauma centers;
p.001185: (5) subject to subsection (b), contains national standards and requirements, including those of the American
p.001185: Academy of Pediatrics and the American College of Emergency Physicians, for medically directed triage and
p.001185: transport of severely injured children to designated trauma centers with specified capabili- ties and
p.001185: expertise in the care of pediatric trauma patients;
p.001185: (6) utilizes a program with procedures for the evaluation of designated trauma centers (including trauma
p.001185: centers de- scribed in paragraph (5)) and trauma care systems;
p.001185: (7) provides for the establishment and collection of data in accordance with data collection requirements developed in
p.001185: con- sultation with surgical, medical, and nursing specialty groups, State and local emergency medical services
p.001185: directors, and other trained professionals in trauma care, from each designated trauma center in the State
p.001185: of a central data reporting and analysis system—
p.001185: (A) to identify the number of severely injured trauma patients and the number of deaths from trauma
p.001185: within trauma care systems in the State;
p.001185: (B) to identify the cause of the injury and any factors contributing to the injury;
p.001185: (C) to identify the nature and severity of the injury;
p.001185: (D) to monitor trauma patient care (including prehospital care) in each designated trauma center
p.001185: within regional trauma care systems in the State (including rel- evant emergency-department discharges and
p.001185: rehabilitation information) for the purpose of evaluating the diagnosis, treatment, and treatment outcome of
p.001185: such trauma pa- tients;
p.001185: (E) to identify the total amount of uncompensated trauma care expenditures for each fiscal year by each des-
p.001185: ignated trauma center in the State; and
p.001185: (F) to identify patients transferred within a regional trauma system, including reasons for such transfer
p.001185: and the outcomes of such patients;
p.001185: (8) provides for the use of procedures by paramedics and emergency medical technicians to assess the severity
p.001185: of the in- juries incurred by trauma patients;
p.001185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001185: Sec. 1213 PUBLIC HEALTH SERVICE ACT 1186
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p.001185: (9) provides for appropriate transportation and transfer policies to ensure the delivery of patients to
p.001185: designated trauma centers and other facilities within and outside of the jurisdic- tion of such system,
p.001185: including policies to ensure that only indi- viduals appropriately identified as trauma patients are trans-
p.001185: ferred to designated trauma centers, and to provide periodic re- views of the transfers and the auditing of
p.001185: such transfers that are determined to be appropriate;
p.001185: (10) conducts public education activities concerning injury prevention and obtaining access to trauma care;
p.001185: (11) coordinates planning for trauma systems with State disaster emergency planning and bioterrorism
p.001185: hospital pre- paredness planning; and
p.001185: (12) with respect to the requirements established in this subsection, provides for coordination and
p.001185: cooperation between the State and any other State with which the State shares any standard metropolitan statistical
p.001185: area.
p.001185: (b) CERTAIN STANDARDS WITH RESPECT TO TRAUMA CARE CEN-
p.001185: TERS AND SYSTEMS.—
p.001185: (1) IN GENERAL.—The Secretary may not make payments under section 1211(a) for a fiscal year unless the
p.001185: State in- volved agrees that, in carrying out paragraphs (3) through (5) of subsection (a), the State
p.001185: will adopt standards for the des- ignation of trauma centers, and for triage, transfer, and trans- portation
p.001185: policies, and that the State will, in adopting such standards—
p.001185: (A) take into account national standards that outline resources for optimal care of injured patients;
p.001185: (B) consult with medical, surgical, and nursing spe- ciality groups, hospital associations, emergency
p.001185: medical services State and local directors, concerned advocates, and other interested parties;
p.001185: (C) conduct hearings on the proposed standards after providing adequate notice to the public concerning
p.001185: such hearing; and
p.001185: (D) beginning in fiscal year 2008, take into account the model plan described in subsection (c).
p.001185: (2) QUALITY OF TRAUMA CARE.—The highest quality of trauma care shall be the primary goal of State
p.001185: standards adopted under this subsection.
p.001185: (3) APPROVAL BY THE SECRETARY.—The Secretary may not make payments under section 1211(a) to a State if
p.001185: the Sec- retary determines that—
p.001185: (A) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not taken
p.001185: into ac- count national standards, including those of the American College of Surgeons, the American College of
p.001185: Emergency Physicians, and the American Academy of Pediatrics, in adopting standards under this subsection; or
p.001185: (B) in the case of payments for fiscal year 2008 and subsequent fiscal years, the State has not, in
p.001185: adopting such standards, taken into account the model plan devel- oped under subsection (c).
p.001185: (c) MODEL TRAUMA CARE PLAN.—
p.001185: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001187: 1187
p.001187: PUBLIC HEALTH SERVICE ACT
p.001187: Sec. 1214
p.001187:
p.001187: (1) IN GENERAL.—Not later than 1 year after the date of the enactment of the Trauma Care Systems Planning and
p.001187: De- velopment Act of 2007, the Secretary shall update the model plan for the designation of trauma
p.001187: centers and for triage, transfer, and transportation policies that may be adopted for guidance by the State.
p.001187: Such plan shall—
p.001187: (A) take into account national standards, including those of the American College of Surgeons, American
p.001187: Col- lege of Emergency Physicians, and the American Academy of Pediatrics;
p.001187: (B) take into account existing State plans;
p.001187: (C) be developed in consultation with medical, sur- gical, and nursing speciality groups, hospital
p.001187: associations, emergency medical services State directors and associa- tions, and other interested parties; and
p.001187: (D) include standards for the designation of rural health facilities and hospitals best able to
p.001187: receive, sta- bilize, and transfer trauma patients to the nearest appro- priate designated trauma center,
p.001187: and for triage, transfer, and transportation policies as they relate to rural areas.
p.001187: (2) APPLICABILITY.—Standards described in paragraph (1)(D) shall be applicable to all rural areas in the State,
p.001187: includ- ing both non-metropolitan areas and frontier areas that have populations of less than 6,000 per square
p.001187: mile.
p.001187: (d) RULE OF CONSTRUCTION WITH RESPECT TO NUMBER OF DESIGNATED TRAUMA CENTERS.—With respect to
p.001187: compliance with subsection (a) as a condition of the receipt of a grant under section 1211(a), such subsection may not
p.001187: be construed to specify the num- ber of trauma care centers designated pursuant to such subsection.
p.001187: SEC. 1214. ø300d–14¿ REQUIREMENT OF SUBMISSION TO SECRETARY OF TRAUMA PLAN AND CERTAIN INFORMATION.
p.001187: (a) IN GENERAL.—For each fiscal year, the Secretary may not make payments to a State under section 1211(a)
p.001187: unless, subject to subsection (b), the State submits to the Secretary the trauma care component of the State plan for
p.001187: the provision of emergency medical services, including any changes to the trauma care component and any plans to
p.001187: address deficiencies in the trauma care component.
p.001187: (b) INTERIM PLAN OR DESCRIPTION OF EFFORTS.—For each fis- cal year, if a State has not completed the
p.001187: trauma care component of the State plan described in subsection (a), the State may provide, in lieu of such completed
p.001187: component, an interim component or a de- scription of efforts made toward the completion of the component.
p.001187: (c) INFORMATION RECEIVED BY STATE REPORTING AND ANALYSIS SYSTEM.—The Secretary may not make payments to a State
p.001187: under section 1211(a) unless the State agrees that the State will, not less than once each year, provide to the
p.001187: Secretary the information re- ceived by the State pursuant to section 1213(a)(7).
p.001187: (d) AVAILABILITY OF EMERGENCY MEDICAL SERVICES IN RURAL AREAS.—The Secretary may not make payments to a
p.001187: State under section 1211(a) unless—
p.001187: (1) the State identifies any rural area in the State for which—
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p.001187: (A) there is no system of access to emergency medical services through the telephone number 911;
p.001187: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001187:
p.001187: (B) there is no basic life-support system; or
p.001187: (C) there is no advanced life-support system; and
p.001187: (2) the State submits to the Secretary a list of rural areas identified pursuant to paragraph (1) or, if there
p.001187: are no such areas, a statement that there are no such areas.
p.001187: SEC. 1215. ø300d–15¿ RESTRICTIONS ON USE OF PAYMENTS.
p.001187: (a) IN GENERAL.—The Secretary may not, except as provided in subsection (b), make payments under section 1211(a)
p.001187: for a fiscal year unless the State involved agrees that the payments will not be expended—
p.001187: (1) for any purpose other than developing, implementing, and monitoring the modifications required by section
p.001187: 1211(b) to be made to the State plan for the provision of emergency med- ical services;
p.001187: (2) to make cash payments to intended recipients of serv- ices provided pursuant to this section;
p.001187: (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property);
p.001187: (4) to satisfy any requirement for the expenditure of non- Federal funds as a condition for the receipt
p.001187: of Federal funds; or
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p.001187: (5) to provide financial assistance to any entity other than a public or nonprofit private entity.
p.001187: (b) WAIVER.—The Secretary may waive a restriction under sub- section (a) only if the Secretary determines that the
p.001187: activities out- lined by the State plan submitted under section 1214(a) by the State involved cannot
p.001187: otherwise be carried out.
p.001187: SEC. 1217. ø300d–17¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
p.001187: The Secretary may not make payments under section 1211(a) to a State for a fiscal year unless—
p.001187: (1) the State submits to the Secretary an application for the payments containing agreements in
p.001187: accordance with this part;
p.001187: (2) the agreements are made through certification from the chief executive officer of the State;
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p.001191: Secretary. The Secretary shall, for the payment of ex- penses incurred in complying with such request,
p.001191: expend the amounts withheld.
p.001191: SEC. 1222. ø300d–22¿ REPORT BY SECRETARY.
p.001191: Not later than October 1, 2008, the Secretary shall report to the appropriate committees of Congress on
p.001191: the activities of the States carried out pursuant to section 1211. Such report shall in- clude an
p.001191: assessment of the extent to which Federal and State ef- forts to develop systems of trauma care and to
p.001191: designate trauma centers have reduced the incidence of mortality, and the incidence of permanent
p.001191: disability, resulting from trauma. Such report may include any recommendations of the Secretary for
p.001191: appropriate ad- ministrative and legislative initiatives with respect to trauma care.
p.001191: PART C—GENERAL PROVISIONS REGARDING PARTS A AND B
p.001191: SEC. 1231. ø300d–31¿ DEFINITIONS.
p.001191: For purposes of this part and parts A and B:
p.001191: (1) DESIGNATED TRAUMA CENTER.—The term ‘‘designated trauma center’’ means a trauma center designated in
p.001191: accord- ance with the modifications to the State plan described in sec- tion 1213.
p.001191: (2) STATE PLAN REGARDING EMERGENCY MEDICAL SERV- ICES.—The term ‘‘State plan’’, with respect to the
p.001191: provision of emergency medical services, means a plan for a comprehensive, organized system to provide for the
p.001191: access, response, triage, field stabilization, transport, hospital stabilization, definitive care, and
p.001191: rehabilitation of patients of all ages with respect to emergency medical services.
p.001191: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.001191: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
p.001191: (4) TRAUMA.—The term ‘‘trauma’’ means an injury result- ing from exposure to—
p.001191: (A) a mechanical force; or
p.001191: (B) another extrinsic agent, including an extrinsic agent that is thermal, electrical, chemical, or
p.001191: radioactive.
p.001191: (5) TRAUMA CARE COMPONENT OF STATE PLAN.—The term ‘‘trauma care component’’, with respect to components
p.001191: of the State plan for the provision of emergency medical services, means a plan for a comprehensive
p.001191: health care system, within rural and urban areas of the State, for the prompt recognition, prehospital care,
p.001191: emergency medical care, acute surgical and medical care, rehabilitation, and outcome evaluation of seri-
p.001191: ously injured patients.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001191:
p.001191: SEC. 1232. ø300d–32¿ FUNDING.
p.001191: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out parts A and B, subject to subsections (b)
p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
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p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
p.001191: (3) to provide emergency relief to ensure the continued and future availability of trauma services.
p.001191: (b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS.—
p.001191: (1) PARTICIPATION IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL GUIDELINES.—Except as
p.001191: pro- vided in paragraph (2), the Secretary may not award a grant to a trauma center under subsection (a)
p.001191: unless the trauma cen- ter is a participant in a trauma system that substantially com- plies with section 1213.
p.001191: (2) EXEMPTION.—Paragraph (1) shall not apply to trauma centers that are located in States with no existing
p.001191: trauma care system.
p.001191: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001193: 1193
p.001193: PUBLIC HEALTH SERVICE ACT
p.001193: Sec. 1242
p.001193:
p.001193: (3) QUALIFICATION FOR SUBSTANTIAL UNCOMPENSATED CARE COSTS.—The Secretary shall award substantial uncompensated
p.001193: care grants under subsection (a)(1) only to trauma centers meeting at least 1 of the criteria in 1 of
p.001193: the following 3 cat- egories:
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p.001193:
p.001193: Sec. 1243 PUBLIC HEALTH SERVICE ACT 1194
p.001193: 1241(a)(1) according to the percentage described in paragraph (2), subject to the requirements of section
p.001193: 1241(b)(3).
p.001193: (2) PERCENTAGES.—The applicable percentages are as fol- lows:
p.001193: (A) With respect to a category A trauma center, 100 percent of the uncompensated care costs.
p.001193: (B) With respect to a category B trauma center, not more than 75 percent of the uncompensated care costs.
p.001193: (C) With respect to a category C trauma center, not more than 50 percent of the uncompensated care costs.
p.001193: (b) 1 CORE MISSION AWARDS.—
p.001193: (1) IN GENERAL.—In awarding grants under section 1241(a)(2), the Secretary shall—
p.001193: (A) reserve 25 percent of the amount allocated for core mission awards for Level III and Level IV trauma centers; and
p.001193: (B) reserve 25 percent of the amount allocated for core mission awards for large urban Level I and II trauma cen- ters—
p.001193: (i) that have at least 1 graduate medical education fellowship in trauma or trauma related specialties for which
p.001193: demand is exceeding supply;
p.001193: (ii) for which—
p.001193: (I) annual uncompensated care costs exceed
p.001193: $10,000,000; or
p.001193: (II) at least 20 percent of emergency depart- ment visits are charity or self-pay or Medicaid pa- tients; and
p.001193: (iii) that are not eligible for substantial uncompen- sated care awards under section 1241(a)(1).
p.001193: (c) EMERGENCY AWARDS.—In awarding grants under section 1241(a)(3), the Secretary shall—
p.001193: (1) give preference to any application submitted by a trau- ma center that provides trauma care in a geographic
p.001193: area in which the availability of trauma care has significantly de- creased or will significantly
p.001193: decrease if the center is forced to close or downgrade service or growth in demand for trauma services
p.001193: exceeds capacity; and
p.001193: (2) reallocate any emergency awards funds not obligated due to insufficient, or a lack of qualified,
p.001193: applications to the significant uncompensated care award program.
p.001193: SEC. 1243. ø300d–43¿ CERTAIN AGREEMENTS.
p.001193: (a) MAINTENANCE OF FINANCIAL SUPPORT.—The Secretary may require a trauma center receiving a grant under section
p.001193: 1241(a) to maintain access to trauma services at comparable levels to the prior year during the grant period.
p.001193: (b) TRAUMA CARE REGISTRY.—The Secretary may require the trauma center receiving a grant under section
p.001193: 1241(a) to provide data to a national and centralized registry of trauma cases, in ac- cordance with
p.001193: guidelines developed by the American College of Sur- geons, and as the Secretary may otherwise require.
p.001193:
p.001193:
p.001193:
p.001193:
p.001193: January 30, 2020
p.001193: 1 So in law. Subsection (b) includes a paragraph (1) but does not include subsequent
p.001193: paragaraphs.
p.001193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001195: 1195
p.001195: PUBLIC HEALTH SERVICE ACT
p.001195: Sec. 1245
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p.001195: January 30, 2020
p.001195: SEC. 1244. ø300d–44¿ GENERAL PROVISIONS.
p.001195: (a) APPLICATION.—The Secretary may not award a grant to a trauma center under section 1241(a) unless such
p.001195: center submits an application for the grant to the Secretary and the application is in such form, is made in such
p.001195: manner, and contains such agreements, assurances, and information as the Secretary determines to be nec- essary to
p.001195: carry out this part.
p.001195: (b) LIMITATION ON DURATION OF SUPPORT.—The period during which a trauma center receives payments under a grant
p.001195: under sec- tion 1241(a)(3) shall be for 3 fiscal years, except that the Secretary may waive such requirement for a
p.001195: center and authorize such center to receive such payments for 1 additional fiscal year.
p.001195: (c) LIMITATION ON AMOUNT OF GRANT.—Notwithstanding sec- tion 1242(a), a grant under section 1241 may
p.001195: not be made in an amount exceeding $2,000,000 for each fiscal year.
p.001195: (d) ELIGIBILITY.—Except as provided in section 1242(b)(1)(B)(iii), acquisition of, or
p.001195: eligibility for, a grant under sec- tion 1241(a) shall not preclude a trauma center from being eligible for other
p.001195: grants described in such section.
p.001195: (e) FUNDING DISTRIBUTION.—Of the total amount appropriated for a fiscal year under section 1245, 70 percent
p.001195: shall be used for substantial uncompensated care awards under section 1241(a)(1),
p.001195: 20 percent shall be used for core mission awards under section 1241(a)(2), and 10 percent shall be used
p.001195: for emergency awards under section 1241(a)(3).
p.001195: (f) MINIMUM ALLOWANCE.—Notwithstanding subsection (e), if the amount appropriated for a fiscal year under
p.001195: section 1245 is less than $25,000,000, all available funding for such fiscal year shall be used for substantial
p.001195: uncompensated care awards under section 1241(a)(1).
p.001195: (g) SUBSTANTIAL UNCOMPENSATED CARE AWARD DISTRIBUTION AND PROPORTIONAL SHARE.—Notwithstanding section
p.001195: 1242(a), of the amount appropriated for substantial uncompensated care grants for a fiscal year, the
p.001195: Secretary shall—
p.001195: (1) make available—
p.001195: (A) 50 percent of such funds for category A trauma center grantees;
p.001195: (B) 35 percent of such funds for category B trauma center grantees; and
p.001195: (C) 15 percent of such funds for category C trauma center grantees; and
p.001195: (2) provide available funds within each category in a man- ner proportional to the award basis specified
p.001195: in section 1242(a)(2) to each eligible trauma center.
p.001195: (h) REPORT.—Beginning 2 years after the date of enactment of the Patient Protection and Affordable Care Act, and every
p.001195: 2 years thereafter, the Secretary shall biennially report to Congress regard- ing the status of the grants made
p.001195: under section 1241 and on the overall financial stability of trauma centers.
p.001195: SEC. 1245. ø300d–45¿ AUTHORIZATION OF APPROPRIATIONS.
p.001195: For the purpose of carrying out this part, there are authorized to be appropriated $100,000,000 for fiscal year
p.001195: 2009, and such sums as may be necessary for each of fiscal years 2010 through 2015. Such authorization
p.001195: of appropriations is in addition to any
p.001195: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001195:
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p.001195: Sec. 1246 PUBLIC HEALTH SERVICE ACT 1196
p.001195:
p.001195: other authorization of appropriations or amounts that are available for such purpose.
p.001195: SEC. 1246. ø300d–46¿ DEFINITION.
p.001195: In this part, the term ‘‘uncompensated care costs’’ means unre- imbursed costs from serving self-pay, charity, or
p.001195: Medicaid patients, without regard to payment under section 1923 of the Social Secu- rity Act, all of which
p.001195: are attributable to emergency care and trau- ma care, including costs related to subsequent inpatient admissions to the
p.001195: hospital.
p.001195: Part E—Miscellaneous Programs
p.001195:
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p.001195: January 30, 2020
p.001195: SEC. 1251. ø300d–51¿ RESIDENCY TRAINING PROGRAMS IN EMER- GENCY MEDICINE.
p.001195: (a) IN GENERAL.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001195: of planning and de- veloping approved residency training programs in emergency medi- cine.
p.001195: (b) IDENTIFICATION AND REFERRAL OF DOMESTIC VIOLENCE.— The Secretary may make a grant under subsection
p.001195: (a) only if the applicant involved agrees that the training programs under sub- section (a) will provide
p.001195: education and training in identifying and referring cases of domestic violence.
p.001195: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there is authorized
p.001195: to be appropriated
p.001195: $400,000 for each of the fiscal years 2008 though 2012.
p.001195: SEC. 1252. ø300d–52¿ STATE GRANTS FOR PROJECTS REGARDING TRAUMATIC BRAIN INJURY.
p.001195: (a) IN GENERAL.—The Secretary, acting through the Adminis- trator for the Administration for Community
p.001195: Living, may make grants to States and American Indian consortia for the purpose of carrying out projects
p.001195: to improve access to rehabilitation and other services regarding traumatic brain injury.
p.001195: (b) STATE ADVISORY BOARD.—
p.001195: (1) IN GENERAL.—The Secretary may make a grant under subsection (a) only if the State or American Indian
p.001195: consortium involved agrees to establish an advisory board within the ap- propriate health department of
p.001195: the State or American Indian consortium or within another department as designated by the chief executive officer
p.001195: of the State or American Indian consor- tium.
p.001195: (2) FUNCTIONS.—An advisory board established under paragraph (1) shall advise and make recommendations
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p.001205: toll-free number are routed to the appropriate poison control center based on the physical location of the contact
p.001205: rather than the area code of the contact device.
p.001205: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001205: $700,000 for each of fiscal years 2020 through 2024 for the establishment, implementa- tion, and maintenance
p.001205: activities carried out under subsections (a) and (b).
p.001205: SEC. 1272. ø300d–72¿ PROMOTING POISON CONTROL CENTER UTILIZA- TION.
p.001205: (a) IN GENERAL.—The Secretary shall carry out, and expand upon, a national media campaign to educate and
p.001205: support outreach to the public and health care providers about poisoning and toxic exposure prevention and
p.001205: the availability of poison control center re- sources in local communities and to conduct advertising campaigns
p.001205: concerning the nationwide toll-free number and other available communication technologies established,
p.001205: implemented, or main- tained under section 1271(a).
p.001205: (b) CONTRACT WITH ENTITY.—The Secretary may carry out subsection (a) by entering into contracts with one
p.001205: or more public or private entities, including nationally recognized organizations in the field of poison control and
p.001205: national media firms, for the devel- opment and implementation of a nationwide poisoning and toxic ex- posure
p.001205: prevention and poison control center awareness campaign, which may include—
p.001205: (1) the development and distribution of poisoning and toxic exposure prevention awareness materials, applicable
p.001205: public health emergency preparedness and response information, and poison control center awareness materials;
p.001205: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001205:
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p.001207: 1207
p.001207: PUBLIC HEALTH SERVICE ACT
p.001207: Sec. 1273
p.001207:
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p.001207: January 30, 2020
p.001207: (2) television, radio, Internet, and newspaper public serv- ice announcements; and
p.001207: (3) other activities to provide for public and professional awareness and education.
p.001207: (c) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001207: $800,000 for each of fiscal years 2020 through 2024.
p.001207: SEC. 1273. ø300d–73¿ MAINTENANCE OF THE POISON CONTROL CEN- TER GRANT PROGRAM.
p.001207: (a) AUTHORIZATION OF PROGRAM.—The Secretary shall award grants to poison control centers accredited under
p.001207: subsection (c) (or granted a waiver under subsection (d)) and professional organiza- tions in the field of
p.001207: poison control for the purposes of preventing, and providing treatment recommendations for, poisonings and toxic
p.001207: exposures and complying with the operational requirements needed to sustain the accreditation of the center under
p.001207: subsection (c).
p.001207: (b) ADDITIONAL USES OF FUNDS.—In addition to the purposes described in subsection (a), a poison center
p.001207: or professional organi- zation awarded a grant, contract, or cooperative agreement under such subsection
p.001207: may also use amounts received under such grant, contract, or cooperative agreement—
p.001207: (1) to research, establish, implement, and evaluate best practices in the United States for poisoning and toxic
p.001207: exposure prevention, poison control center outreach, and emergency pre- paredness and response programs;
p.001207: (2) to research, develop, implement, revise, and commu- nicate standard patient management guidelines for
p.001207: commonly encountered toxic exposures;
p.001207: (3) to improve national toxic exposure surveillance by en- hancing cooperative activities between poison
p.001207: control centers in the United States, the Centers for Disease Control and Preven- tion, and other government
p.001207: agencies as determined to be ap- propriate and nonduplicative by the Secretary;
p.001207: (4) to research, improve, and enhance the communications and response capability and capacity of the nation’s network
p.001207: of poison control centers to facilitate increased access to the cen- ters through the integration and
p.001207: modernization of the current poison control centers communications and data system, in- cluding enhancing the
p.001207: network’s telephony, Internet, data and social networking technologies;
p.001207: (5) to develop, support, and enhance technology and capa- bilities of professional organizations in the
p.001207: field of poison con- trol to collect national poisoning, toxic occurrence, and related public health data;
p.001207: (6) to develop initiatives to foster the enhanced public health utilization of national poison data collected
p.001207: by organiza- tions described in paragraph (5);
p.001207: (7) to support and expand the toxicologic expertise within poison control centers; and
p.001207: (8) to improve the capacity of poison control centers to an- swer high volumes of contacts and Internet
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p.001207: January 30, 2020
p.001207:
p.001207: (c) ACCREDITATION.—Except as provided in subsection (d), the Secretary may award a grant to a poison control
p.001207: center under sub- section (a) only if—
p.001207: (1) the center has been accredited by a professional organi- zation in the field of poison control, and the Secretary
p.001207: has ap- proved the organization as having in effect standards for ac- creditation that reasonably provide
p.001207: for the protection of the public health with respect to poisoning; or
p.001207: (2) the center has been accredited by a State government, and the Secretary has approved the State government as hav-
p.001207: ing in effect standards for accreditation that reasonably pro- vide for the protection of the public health
p.001207: with respect to poi- soning.
p.001207: (d) WAIVER OF ACCREDITATION REQUIREMENTS.—
p.001207: (1) IN GENERAL.—The Secretary may grant a waiver of the accreditation requirements of subsection (c) with respect
p.001207: to a nonaccredited poison control center that applies for a grant under this section if such center can
p.001207: reasonably demonstrate that the center will obtain such an accreditation within a rea- sonable period of time as
p.001207: determined appropriate by the Sec- retary.
p.001207: (2) RENEWAL.—The Secretary may renew a waiver under paragraph (1).
p.001207: (3) LIMITATION.—
p.001207: (A) IN GENERAL.—The sum of the number of years for a waiver under paragraph (1) and a renewal under para-
p.001207: graph (2) may not exceed 5 years.
p.001207: (B) PUBLIC HEALTH EMERGENCY.—Notwithstanding any previous waivers, in the case of a poison control center
p.001207: whose accreditation is affected by a public health emer- gency declared pursuant to section 319, the Secretary
p.001207: may, as the circumstances of the emergency reasonably require, provide a waiver under paragraph (1) or a
p.001207: renewal under paragraph (2), not to exceed 2 years. The Secretary may require quarterly reports and other
p.001207: information related to such a waiver or renewal under this paragraph.
p.001207: (e) SUPPLEMENT NOT SUPPLANT.—Amounts made available to a poison control center under this section
p.001207: shall be used to supple- ment and not supplant other Federal, State or local funds provided for such center.
p.001207: (f) MAINTENANCE OF EFFORT.—With respect to activities for which a grant is awarded under this section, the
p.001207: Secretary may re- quire that poison control centers agree to maintain the expendi- tures of the center for
p.001207: such activities at a level that is not less than the level of expenditures maintained by the center for the
p.001207: fiscal year preceding the fiscal year for which the grant is received.
p.001207: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001207: $28,600,000 for each of fiscal years 2020 through 2024. The Secretary may utilize an amount not to exceed 6
p.001207: percent of the amount appropriated under this preceding sentence in each fiscal year for coordination, dis-
p.001207: semination, technical assistance, program evaluation, data activi- ties, and other program administration
p.001207: functions, which are deter-
p.001207: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001209: part for a fiscal year to award grants to safety net trauma centers described in paragraph (1)(A)(ii).
p.001209: (d) USE OF FUNDS.—The recipient of a grant under subsection
p.001209: (b) shall carry out 1 or more of the following activities consistent with subsection (b):
p.001209: (1) Providing trauma centers with funding to support phy- sician compensation in trauma-related physician
p.001209: specialties where shortages exist in the region involved, with priority pro- vided to safety net trauma centers
p.001209: described in subsection (c)(1)(A)(ii).
p.001209: (2) Providing for individual safety net trauma center fiscal stability and costs related to having service that is
p.001209: available 24 hours a day, 7 days a week, with priority provided to safety net trauma centers described in
p.001209: subsection (c)(1)(A)(ii) located in urban, border, and rural areas.
p.001209: (3) Reducing trauma center overcrowding at specific trau- ma centers related to throughput of trauma patients.
p.001209: (4) Establishing new trauma services in underserved areas as defined by the State.
p.001209: (5) Enhancing collaboration between trauma centers and other hospitals and emergency medical services
p.001209: personnel re- lated to trauma service availability.
p.001209: (6) Making capital improvements to enhance access and expedite trauma care, including providing helipads and
p.001209: associ- ated safety infrastructure.
p.001209: (7) Enhancing trauma surge capacity at specific trauma centers.
p.001209: (8) Ensuring expedient receipt of trauma patients trans- ported by ground or air to the appropriate trauma
p.001209: center.
p.001209: (9) Enhancing interstate trauma center collaboration.
p.001209: (e) LIMITATION.—
p.001209: (1) IN GENERAL.—A State may use not more than 20 per- cent of the amount available to the State under
p.001209: this part for a fiscal year for administrative costs associated with awarding grants and related costs.
p.001209: (2) MAINTENANCE OF EFFORT.—The Secretary may not pro- vide funding to a State under this part unless the State agrees
p.001209: that such funds will be used to supplement and not supplant State funding otherwise available for the
p.001209: activities and costs described in this part.
p.001209: (f) DISTRIBUTION OF FUNDS.—The following shall apply with re- spect to grants provided in this part:
p.001209: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001211: (i) $100,000 for each military trauma care pro- vider that is a physician at such eligible trauma cen-
p.001211: ter; and
p.001211: (ii) $50,000 for each other military trauma care provider at such eligible trauma center.
p.001211: (c) GRANT REQUIREMENTS.—
p.001211: (1) DEPLOYMENT AND PUBLIC HEALTH EMERGENCIES.—As a condition of receipt of a grant under this section, a
p.001211: grant re- cipient shall agree to allow military trauma care providers pro- viding care pursuant to such grant to—
p.001211: (A) be deployed by the Secretary of Defense for mili- tary operations, for training, or for response to a mass
p.001211: cas- ualty incident; and
p.001211: (B) be deployed by the Secretary of Defense, in con- sultation with the Secretary of Health and Human
p.001211: Serv- ices, for response to a public health emergency pursuant to section 319.
p.001211: (2) USE OF FUNDS.—Grants awarded under this section to an eligible trauma center may be used to train and
p.001211: incorporate military trauma care providers into such trauma center, in- cluding incorporation into
p.001211: operational exercises and training drills related to public health emergencies, expenditures for malpractice
p.001211: insurance, office space, information technology, specialty education and supervision, trauma
p.001211: programs, re- search, and applicable license fees for such military trauma care providers.
p.001211: (d) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to affect any other provision of
p.001211: law that preempts State licensing requirements for health care professionals, including with respect to military
p.001211: trauma care providers.
p.001211: (e) REPORTING REQUIREMENTS.—
p.001211: (1) REPORT TO THE SECRETARY AND THE SECRETARY OF DE- FENSE.—Each eligible trauma center or eligible
p.001211: high-acuity trauma center awarded a grant under subsection (a) or (b) for a year shall submit to the Secretary
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p.001213: (A) maintaining military trauma care providers’ readi- ness and ability to respond to and treat battlefield injuries;
p.001213: (B) providing health care to civilian trauma patients in urban and rural settings;
p.001213: (C) the capability of trauma centers and military trau- ma care providers to increase medical surge capacity,
p.001213: in- cluding as a result of a large-scale event;
p.001213: (D) the ability of grant recipients to maintain the inte- gration of the military trauma providers or teams of
p.001213: pro- viders as part of the trauma center;
p.001213: (E) efforts to incorporate military trauma care pro- viders into operational exercises and training and drills
p.001213: for public health emergencies; and
p.001213: (F) the capability of military trauma care providers to participate as part of a medical response during or in
p.001213: ad- vance of a public health emergency, as determined by the Secretary, or a mass casualty incident.
p.001213: (f) DEFINITIONS.—For purposes of this part:
p.001213: (1) ELIGIBLE HIGH-ACUITY TRAUMA CENTER.—The term ‘‘eli- gible high-acuity trauma center’’ means a Level I trauma
p.001213: cen- ter that satisfies each of the following:
p.001213: (A) Such trauma center has an agreement with the Secretary of Defense to enable military trauma teams
p.001213: to provide trauma care and related acute care at such trauma center.
p.001213: (B) At least 20 percent of patients treated at such trauma center in the most recent 3-month period for which
p.001213: data are available are treated for a major trauma at such trauma center.
p.001213: (C) Such trauma center utilizes a risk-adjusted benchmarking system and metrics to measure perform-
p.001213: ance, quality, and patient outcomes.
p.001213: (D) Such trauma center is an academic training cen- ter—
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p.001213: (i) affiliated with a medical school;
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p.001213: ance, quality, and patient outcomes.
p.001213: (C) Such trauma center demonstrates a need for inte- grated military trauma care providers to maintain
p.001213: or im- prove the trauma clinical capability of such trauma center.
p.001213: (3) MAJOR TRAUMA.—The term ‘‘major trauma’’ means an injury that is greater than or equal to 15 on the injury
p.001213: severity score.
p.001213: (4) MILITARY TRAUMA TEAM.—The term ‘‘military trauma team’’ means a complete military trauma team
p.001213: consisting of military trauma care providers.
p.001213: (5) MILITARY TRAUMA CARE PROVIDER.—The term ‘‘military trauma care provider’’ means a member of the Armed
p.001213: Forces who furnishes emergency, critical care, and other trauma acute care services (including a physician, surgeon,
p.001213: physician assist- ant, nurse, nurse practitioner, respiratory therapist, flight paramedic, combat medic,
p.001213: or enlisted medical technician) or other military trauma care provider as the Secretary deter- mines
p.001213: appropriate.
p.001213: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated $11,500,000
p.001213: for each of fiscal years 2019 through 2023.
p.001213: TITLE XIII—HEALTH MAINTENANCE ORGANIZATIONS
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p.001213: January 30, 2020
p.001213:
p.001213: REQUIREMENTS FOR HEALTH MAINTENANCE ORGANIZATIONS
p.001213: SEC. 1301. ø300e¿ (a) For purposes of this title, the term ‘‘health maintenance organization’’ means a public
p.001213: or private entity which is organized under the laws of any State and which (1) pro- vides basic and supplemental health
p.001213: services to its members in the manner prescribed by subsection (b), and (2) is organized and oper- ated in the manner
p.001213: prescribed by subsection (c).
p.001213: (b) A health maintenance organization shall provide, without limitations as to time or cost other than
p.001213: those prescribed by or under this title, basic and supplemental health services to its mem- bers in the following
p.001213: manner:
p.001213: (1) Each member is to be provided basic health services for a basic health services payment which (A) is to be
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p.001215: case of an entity which before it became a qualified health maintenance organization (within the meaning of
p.001215: section 1310(d)) provided comprehensive health services on a prepaid basis, the requirement of this sentence
p.001215: shall not apply to such entity during the forty-eight month period beginning with the month following the month
p.001215: in which the entity became such a qualified health maintenance organization.
p.001215: (3)(A) Except as provided in subparagraph (B), at least 90 percent of the services of a physician which are
p.001215: provided as basic health services shall be provided through—
p.001215: (i) members of the staff of the health maintenance or- ganization,
p.001215: (ii) a medical group (or groups),
p.001215: (iii) an individual practice association (or associations),
p.001215: (iv) physicians or other health professionals who have contracted with the health maintenance organization for
p.001215: the provision of such services, or
p.001215: (v) any combination of such staff, medical group (or groups), individual practice association (or associations)
p.001215: or physicians or other health professionals under contract with the organization.
p.001215: (B) Subparagraph (A) does not apply to the provision of the services of a physician—
p.001215: (i) which the health maintenance organization deter- mines, in conformity with regulations of the Secretary, are
p.001215: unusual or infrequently used, or
p.001215: (ii) which are provided a member of the organization in a manner other than that prescribed by
p.001215: subparagraph
p.001215: (A) because of an emergency which made it medically nec- essary that the service be provided to the member
p.001215: before it could be provided in a manner prescribed by subpara- graph (A).
p.001215: (C) Contracts between a health maintenance organization and health professionals for the provision of basic and
p.001215: supple- mental health services shall include such provisions as the Sec- retary may require (including provisions
p.001215: requiring appropriate continuing education).
p.001215: (D) Contracts between a health maintenance organization and health professionals for the provision of basic and
p.001215: supple- mental health services shall include such provisions as the Sec- retary may require, but only to the
p.001215: extent that such require- ments are designed to insure the delivery of quality health care services and
p.001215: sound fiscal management.
p.001215: (4) Basic health services (and only such supplemental health services as members have contracted
p.001215: for) shall within the area served by the health maintenance organization be available and accessible to each
p.001215: of its members with reasonable
p.001215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001217: PUBLIC HEALTH SERVICE ACT
p.001217: Sec. 1301
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p.001217: promptness and in a manner which assures continuity, and when medically necessary be available and
p.001217: accessible twenty- four hours a day and seven days a week, except that a health maintenance organization which has
p.001217: a service area located wholly in a nonmetropolitan area may make a basic health service available outside
p.001217: its service area if that basic health service is not a primary care or emergency health care service and if
p.001217: there is an insufficient number of providers of that basic health service within the service area who will
p.001217: provide such service to members of the health maintenance organization. A member of a health maintenance
p.001217: organization shall be reim- bursed by the organization for his expenses in securing basic and supplemental
p.001217: health services other than through the orga- nization if the services were medically necessary and imme-
p.001217: diately required because of an unforeseen illness, injury, or condition.
p.001217: (5) To the extent that a natural disaster, war, riot, civil in- surrection, or any other similar event not within the
p.001217: control of a health maintenance organization (as determined under regu- lations of the Secretary) results in the
p.001217: facilities, personnel, or financial resources of a health maintenance organization not being available to
p.001217: provide or arrange for the provision of a basic or supplemental health service in accordance with the re-
p.001217: quirements of paragraphs (1) through (4) of this subsection, such requirements only require the
p.001217: organization to make a good-faith effort to provide or arrange for the provision of such service within such
p.001217: limitation on its facilities, personnel, or re- sources.
p.001217: (6) A health maintenance organization that otherwise meets the requirements of this title may offer a
p.001217: high-deductible health plan (as defined in section 220(c)(2) of the Internal Rev- enue Code of 1986).
p.001217: (c) Each health maintenance organization shall— (1)(A) have—
p.001217: (i) a fiscally sound operation, and
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p.001219: health status of its members, and (E) such other matters as the Secretary may require.
p.001219: The Secretary shall issue regulations stating the circumstances under which the Secretary, in administering
p.001219: paragraph (1)(A), will consider the resources of an organization which owns or controls a health maintenance
p.001219: organization. Such regulations shall require as a condition to consideration of resources that an organization which
p.001219: owns or controls a health maintenance organization shall provide satisfactory assurances that it will assume
p.001219: the financial obligations of the health maintenance organization.
p.001219: (d) An organization that offers health benefits coverage shall not be considered as failing to meet the
p.001219: requirements of this sec- tion notwithstanding that it provides, with respect to coverage of- fered in
p.001219: connection with a group health plan in the small or large group market (as defined in section 2791(e)), an
p.001219: affiliation period consistent with the provisions of section 2701(g).
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p.001219: January 30, 2020
p.001219: DEFINITIONS
p.001219: SEC. 1302. ø300e–1¿ For purposes of this title:
p.001219: (1) The term ‘‘basic health services’’ means—
p.001219: (A) physician services (including consultant and referral services by a physician);
p.001219: (B) inpatient and outpatient hospital services;
p.001219: (C) medically necessary emergency health services;
p.001219: (D) short-term (not to exceed twenty visits), outpatient evaluative and crisis intervention mental health
p.001219: services;
p.001219: (E) medical treatment and referral services (including re- ferral services to appropriate ancillary
p.001219: services) for the abuse of or addiction to alcohol and drugs;
p.001219: (F) diagnostic laboratory and diagnostic and therapeutic radiologic services;
p.001219: (G) home health services; and
p.001219: (H) preventive health services (including (i) immuniza- tions, (ii) well-child care from birth, (iii) periodic
p.001219: health evalua- tions for adults, (iv) voluntary family planning services, (v) in- fertility services, and (vi)
p.001219: children’s eye and ear examinations conducted to determine the need for vision and hearing correc- tion).
p.001219: Such term does not include a health service which the Secretary, upon application of a health maintenance
p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
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p.001287: convenience of and at the request of the State and for the purpose of conducting activities described
p.001287: in section 1904. The amount by which any payment is so reduced shall be available for payment by the
p.001287: Secretary of the costs in- curred in furnishing the supplies or equipment or in detailing the personnel,
p.001287: on which the reduction of the payment is based, and the amount shall be deemed to be part of the payment and
p.001287: shall be deemed to have been paid to the State.
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p.001287: January 30, 2020
p.001287: USE OF ALLOTMENTS
p.001287: SEC. 1904. ø300w–3¿ (a)(1) Except as provided in subsections
p.001287: (b) and (c), payments made to a State under section 1903 may be used for the following:
p.001287: (A) Activities consistent with making progress toward achieving the objectives established by the
p.001287: Secretary for the health status of the population of the United States for the year 2000 (in this part
p.001287: referred to as ‘‘year 2000 health objec- tives’’).
p.001287: (B) Preventive health service programs for the control of rodents and for community and school-based
p.001287: fluoridation pro- grams.
p.001287: (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and
p.001287: im- provement of such systems. Amounts for such systems may not be used for the costs of the operation of the systems
p.001287: or the pur- chase of equipment for the systems, except that such amounts may be used for the payment of not
p.001287: more than 50 percent of the costs of purchasing communications equipment for the sys- tems. Amounts may be expended
p.001287: for feasibility studies or plan- ning for the trauma-care components of such systems only if the studies or
p.001287: planning, respectively, is consistent with the re- quirements of section 1213(a).
p.001287: (D) Providing services to victims of sex offenses and for prevention of sex offenses.
p.001287: (E) The establishment, operation, and coordination of effec- tive and cost-efficient systems to reduce the
p.001287: prevalence of ill- ness due to asthma and asthma-related illnesses, especially among children, by reducing the
p.001287: level of exposure to cockroach allergen or other known asthma triggers through the use of in- tegrated pest
p.001287: management, as applied to cockroaches or other known allergens. Amounts expended for such systems may in- clude
p.001287: the costs of building maintenance and the costs of pro- grams to promote community participation in the
p.001287: carrying out at such sites of integrated pest management, as applied to
p.001287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001289: through use of the uniform criteria developed by the Secretary under paragraph (3) of such section.
p.001289: (6) With respect to the activities authorized in section 1904, the State agrees to maintain State expenditures
p.001289: for such activities at a level that is not less than the average level of such expenditures maintained
p.001289: by the State for the 2-year pe- riod preceding the fiscal year for which the State is applying to
p.001289: receive payments under section 1903.
p.001289: (7) The State agrees to establish reasonable criteria to evaluate the effective performance of
p.001289: entities that receive funds from such payments and procedures for procedural and substantive independent
p.001289: State review of the failure by the State to provide funds for any such entity.
p.001289: (8) The State agrees to permit and cooperate with Federal investigations undertaken in accordance with section 1907.
p.001289: (9) The State has in effect a system to protect from inap- propriate disclosure patient and sex offense
p.001289: victim records maintained by the State in connection with an activity funded under this part or by any entity
p.001289: which is receiving payments from the allotment of the State under this part.
p.001289: (10) The State agrees to provide the officer of the State government responsible for the administration
p.001289: of the State highway safety program with an opportunity to—
p.001289: (A) participate in the development of any plan by the State relating to emergency medical services, as such
p.001289: plan relates to highway safety; and
p.001289: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001289:
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p.001291: 1291
p.001291: PUBLIC HEALTH SERVICE ACT
p.001291: Sec. 1906
p.001291:
p.001291: (B) review and comment on any proposal by any State agency to use any Federal grant or Federal payment re-
p.001291: ceived by the State for the provision of emergency medical services as such proposal relates to highway safety.
p.001291: (d) STATE ADVISORY COMMITTEE.—
p.001291: (1) IN GENERAL.—For purposes of subsection (c)(2), an ad- visory committee is in accordance with this
p.001291: subsection if such committee is known as the State Preventive Health Advisory Committee (in this
p.001291: subsection referred to as the ‘‘Committee’’) and the Committee meets the conditions described in the sub- sequent
p.001291: paragraphs of this subsection.
p.001291: (2) DUTIES.—A condition under paragraph (1) for a State is that the duties of the Committee are—
p.001291: (A) to hold public hearings on the State plan required in subsection (a)(2); and
p.001291: (B) to make recommendations pursuant to subsection (b)(1) regarding the development and implementation of
p.001291: such plan, including recommendations on—
p.001291: (i) the conduct of assessments of the public health;
p.001291: (ii) which of the activities authorized in section 1904 should be carried out in the State;
p.001291: (iii) the allocation of payments made to the State under section 1903;
p.001291: (iv) the coordination of activities carried out under such plan with relevant programs of other entities; and
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p.001291: (v) the collection and reporting of data in accord- ance with section 1906(a).
p.001291: (3) COMPOSITION.—
p.001291: (A) A condition under paragraph (1) for a State is that the Committee is composed of such members of the general
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p.001295: Sec. 1910
p.001295:
p.001295: (c) When a matter is referred to the Attorney General pursuant to subsection (b)(1), or whenever he has reason
p.001295: to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of
p.001295: law referred to in subsection (a)(1) or in violation of subsection (a)(2), the Attorney General may bring a
p.001295: civil action in any appropriate district court of the United States for such relief as may be appropriate, including
p.001295: injunctive relief.
p.001295: CRIMINAL PENALTY FOR FALSE STATEMENTS
p.001295: SEC. 1909. ø300w–8¿ Whoever—
p.001295: (1) knowingly and willfully makes or causes to be made any false statement or representation of a material
p.001295: fact in con- nection with the furnishing of items or services for which pay- ment may be made by a State from funds
p.001295: allotted to the State under this part, or
p.001295: (2) having knowledge of the occurrence of any event affect- ing his initial or continued right to any such payment
p.001295: conceals or fails to disclose such event with an intent fraudulently to se- cure such payment either in a greater
p.001295: amount than is due or when no such payment is authorized,
p.001295: shall be fined not more than $25,000 or imprisoned for not more than five years, or both.
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p.001295: EMERGENCY MEDICAL SERVICES FOR CHILDREN
p.001295: SEC. 1910. ø300w–9¿ (a) For activities in addition to the activi- ties which may be carried out by States under section
p.001295: 1904(a)(1)(F), the Secretary may make grants to States or accredited schools of medicine in States to support
p.001295: a program of demonstration projects for the expansion and improvement of emergency medical services for
p.001295: children who need treatment for trauma or critical care. Any grant made under this subsection shall be
p.001295: for not more than a 4- year period (with an optional 5th year based on performance), sub- ject to annual
p.001295: evaluation by the Secretary. Only 3 grants under this subsection may be made in a State (to a State
p.001295: or to a school of medicine in such State) in any fiscal year.
p.001295: (b) The Secretary may renew a grant made under subsection
p.001295: (a) for one additional one-year period only if the Secretary deter- mines that renewal of such grant
p.001295: will provide significant benefits through the collection, analysis, and dissemination of information or data
p.001295: which will be useful to States in which grants under such subsection have not been made.
p.001295: (c) For purposes of this section—
p.001295: (1) the term ‘‘school of medicine’’ has the same meaning as in section 701(4); and
p.001295: (2) the term ‘‘accredited’’ has the same meaning as in sec- tion 701(5).
p.001295: (d) To carry out this section, there are authorized to be appro- priated $2,000,000 for fiscal year 1985 and for each
p.001295: of the two suc- ceeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000
p.001295: for each of the fiscal years 1991 and 1992, such sums as may be necessary for each of the fiscal
p.001295: years 1993 through 2005, $25,000,000 for fiscal year 2010, $26,250,000 for fiscal year 2011, $27,562,500
p.001295: for fiscal year 2012, $28,940,625
p.001295: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001295:
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p.001297: to subsection (c)), the plan shall provide for a system of in- tegrated social services, educational services, child
p.001297: welfare services, juvenile justice services, law enforcement serv- ices, and substance use disorder services
p.001297: that, together with health and mental health services, will be provided in order for such children to receive care
p.001297: appropriate for their multiple needs (such system to include services provided under the Individuals with
p.001297: Disabilities Education Act).
p.001297: (D) TARGETED SERVICES TO RURAL AND HOMELESS POP- ULATIONS.—Theplan shall describe the State’s outreach to
p.001297: and services for individuals who are homeless and how community-based services will be provided to
p.001297: individuals residing in rural areas.
p.001297: (E) MANAGEMENT SERVICES.—The plan shall describe the financial resources available, the existing
p.001297: mental health workforce, and the workforce trained in treating in- dividuals with co-occurring mental and
p.001297: substance use dis- orders, and shall provide for the training of providers of emergency health services
p.001297: regarding mental health. The plan shall further describe the manner in which the State intends to expend the grant
p.001297: under section 1911 for the fis- cal year involved, and the manner in which the State in- tends to comply
p.001297: with each of the funding agreements in this subpart and subpart III.
p.001297:
p.001297: (2) GOALS AND OBJECTIVES.—The establishment of goals and objectives for the period of the plan, including
p.001297: targets and milestones that are intended to be met, and the activities that will be undertaken to achieve those
p.001297: targets.
p.001297: (c) DEFINITIONS REGARDING MENTAL ILLNESS AND EMOTIONAL DISTURBANCE; METHODS FOR ESTIMATE OF INCIDENCE AND
p.001297: PREVA-
p.001297: LENCE.—
p.001297: (1) ESTABLISHMENT BY SECRETARY OF DEFINITIONS; DIS- SEMINATION.—For purposes of this subpart, the Secretary
p.001297: shall establish definitions for the terms ‘‘adults with a serious men- tal illness’’ and ‘‘children with a
p.001297: serious emotional disturb- ance’’. The Secretary shall disseminate the definitions to the States.
p.001297: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001297:
p.001297:
p.001297:
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p.001299: 1299
p.001299: PUBLIC HEALTH SERVICE ACT
p.001299: Sec. 1913
p.001299:
p.001299: (2) STANDARDIZED METHODS.—The Secretary shall estab- lish standardized methods for making the estimates
...

p.001299: (2) services under the plan will be provided through com- munity mental health centers only if the centers
p.001299: meet the cri- teria specified in subsection (c).
p.001299: (c) CRITERIA FOR MENTAL HEALTH CENTERS.—The criteria re- ferred to in subsection (b)(2) regarding
p.001299: community mental health centers are as follows:
p.001299: (1) With respect to mental health services, the centers pro- vide services as follows:
p.001299: (A) Services principally to individuals residing in a de- fined geographic area (hereafter in this subsection referred
p.001299: to as a ‘‘service area’’).
p.001299: (B) Outpatient services, including specialized out- patient services for children, the elderly,
p.001299: individuals with a serious mental illness, and residents of the service areas of the centers who have been
p.001299: discharged from inpatient treatment at a mental health facility.
p.001299:
p.001299:
p.001299:
p.001299:
p.001299: January 30, 2020
p.001299: 2 So in law. See section 201 of Public Law 102–321 (106 Stat. 381). Probably should be ‘‘dis-
p.001299: turbance’’.
p.001299: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001299:
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p.001301: 1301
p.001301: PUBLIC HEALTH SERVICE ACT
p.001301: Sec. 1914
p.001301:
p.001301: (C) 24-hour-a-day emergency care services.
p.001301: (D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services.
p.001301: (E) Screening for patients being considered for admis- sion to State mental health facilities to determine the
p.001301: ap- propriateness of such admission.
p.001301: (2) The mental health services of the centers are provided, within the limits of the capacities of the centers,
p.001301: to any indi- vidual residing or employed in the service area of the center regardless of ability to pay
p.001301: for such services.
p.001301: (3) The mental health services of the centers are available and accessible promptly, as appropriate and in a manner
p.001301: which preserves human dignity and assures continuity and high qual- ity care.
p.001301: SEC. 1914. ø300x–3¿ STATE MENTAL HEALTH PLANNING COUNCIL.
p.001301: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 is that the State involved will
p.001301: establish and maintain a State mental health planning council in accordance with the condi- tions described in this
p.001301: section.
p.001301: (b) DUTIES.—A condition under subsection (a) for a Council is that the duties of the Council are—
p.001301: (1) to review plans provided to the Council pursuant to section 1915(a) by the State involved and to
p.001301: submit to the State any recommendations of the Council for modifications to the plans;
p.001301: (2) to serve as an advocate for adults with a serious men- tal illness, children with a severe emotional
p.001301: disturbance, and other individuals with mental illnesses or emotional problems; and
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
p.001301:
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p.001301:
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p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
p.001337: SEC. 1956. ø300x–66¿ SERVICES FOR INDIVIDUALS WITH CO-OCCUR- RING DISORDERS.
p.001337: States may use funds available for treatment under sections 1911 and 1921 to treat persons with
p.001337: co-occurring substance abuse and mental disorders as long as funds available under such sec- tions are
p.001337: used for the purposes for which they were authorized by law and can be tracked for accounting purposes.
p.001337: SEC. 1957. ø300x-67¿ PUBLIC HEALTH EMERGENCIES.
p.001337: In the case of a public health emergency (as determined under section 319), the Secretary, on a State by State basis,
p.001337: may, as the circumstances of the emergency reasonably require and for the pe-
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001337:
p.001337:
p.001337:
p.001337:
p.001337:
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p.001337:
p.001337: Sec. 1958 PUBLIC HEALTH SERVICE ACT 1338
p.001337:
p.001337: riod of the emergency, grant an extension, or waive application deadlines or compliance with any other
p.001337: requirement, of a grant au- thorized under section 521, 1911, or 1921 or an allotment author- ized under
p.001337: Public Law 99–319 (42 U.S.C. 10801 et seq.).
p.001337: SEC. 1958. ø300x-68¿ JOINT APPLICATIONS.
p.001337: The Secretary, acting through the Assistant Secretary for Men- tal Health and Substance Use, shall permit a
p.001337: joint application to be submitted for grants under subpart I and subpart II upon the request of a
p.001337: State. Such application may be jointly reviewed and approved by the Secretary with respect to such subparts,
p.001337: consistent with the purposes and authorized activities of each such grant pro- gram. A State submitting such a
p.001337: joint application shall otherwise meet the requirements with respect to each such subpart.
p.001337:
p.001337: PART C—CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE
p.001337: Subpart I—Data Infrastructure Development
p.001337:
p.001337:
p.001337:
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p.001337:
p.001337:
p.001337: January 30, 2020
p.001337: SEC. 1971. ø300y¿ DATA INFRASTRUCTURE DEVELOPMENT.
p.001337: (a) IN GENERAL.—The Secretary may make grants to, and enter into contracts or cooperative agreements with
...

p.001373: (3) No attorney may charge any fee for services in connec- tion with a petition filed under section 2111 which
p.001373: is in addi- tion to any amount awarded as compensation by the special master or court under paragraph (1).
p.001373: (f) PAYMENT OF COMPENSATION.—
p.001373: (1) Except as provided in paragraph (2), no compensation may be paid until an election has been made,
p.001373: or has been deemed to have been made, under section 2121(a) to receive compensation.
p.001373:
p.001373:
p.001373:
p.001373:
p.001373: January 30, 2020
p.001373: 10 So in law. Probably should be a closing parenthesis after ‘‘subsection (e)’’.
p.001373: 11 Effective October 1, 1988.
p.001373: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001373:
p.001373:
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p.001373:
p.001373:
p.001375: 1375
p.001375: PUBLIC HEALTH SERVICE ACT
p.001375: Sec. 2115
p.001375:
p.001375: (2) Compensation described in subsection (a)(1)(A)(iii) shall be paid from the date of the judgment of the
p.001375: United States Claims Court under section 2112 awarding the compensation. Such compensation may not be paid
p.001375: after an election under section 2121(a) to file a civil action for damages for the vac- cine-related
p.001375: injury or death for which such compensation was awarded.
p.001375: (3) Payments of compensation under the Program and the costs of carrying out the Program shall be exempt from reduc-
p.001375: tion under any order issued under part C of the Balanced Budget and Emergency Deficit Control Act of 1985.
p.001375: (4)(A) 12 Except as provided in subparagraph (B), payment of compensation under the Program shall be determined on the
p.001375: basis of the net present value of the elements of the compensa- tion and shall be paid from the Vaccine Injury
p.001375: Compensation Trust Fund established under section 9510 of the Internal Rev- enue Code of 1986 in a lump sum of which
p.001375: all or a portion may be used as ordered by the special master to purchase an annu- ity or otherwise be used, with the
p.001375: consent of the petitioner, in a manner determined by the special master to be in the best interests of the
p.001375: petitioner.
p.001375: (B) In the case of a payment of compensation under the Program to a petitioner for a vaccine-related
p.001375: injury or death associated with the administration of a vaccine before the ef- fective date of this part
p.001375: 13 the compensation shall be deter- mined on the basis of the net present value of the elements of compensation
p.001375: and paid in 4 equal annual installments of which all or a portion of the proceeds 14 may be used as ordered
p.001375: by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner,
p.001375: in a manner deter- mined by the special master to be in the best interests of the petitioner. Any
p.001375: reasonable attorneys’ fees and costs shall be paid in a lump sum. If the appropriations under subsection (j) are
p.001375: insufficient to make a payment of an annual installment, the limitation on civil actions prescribed by
...

p.001403: (c) DURATION OF SUPPORT.—Support of a center under sub- section (a) may be for not more than five
p.001403: years. Such period may be extended by the Director for additional periods of not more than five years each if the
p.001403: operations of such center have been reviewed by an appropriate technical and scientific peer review group estab- lished
p.001403: by the Director and if such group has recommended to the Director that such period should be extended.
p.001403: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.001403: to be appropriated such sums as may be necessary.
p.001403: SEC. 2317. ø300cc–17¿ INFORMATION SERVICES.
p.001403: (a) ESTABLISHMENT OF PROGRAM.—The Secretary shall estab- lish, maintain, and operate a program with
p.001403: respect to information on research, treatment, and prevention activities relating to infec- tion with the
p.001403: etiologic agent for acquired immune deficiency syn- drome. The program shall, with respect to the
p.001403: agencies of the De- partment of Health and Human Services, be integrated and coordi- nated.
p.001403: (b) TOLL-FREE TELEPHONE COMMUNICATIONS FOR HEALTH CARE ENTITIES.—
p.001403: (1) After consultation with the Director of the Office of AIDS Research, the Administrator of the Health
p.001403: Resources and Services Administration, and the Director of the Centers for Disease Control and Prevention, the
p.001403: Secretary shall provide for toll-free telephone communications to provide medical and technical
p.001403: information with respect to acquired immune defi- ciency syndrome to health care professionals, allied health
p.001403: care providers, and to professionals providing emergency health services.
p.001403: (2) Information provided pursuant to paragraph (1) shall include—
p.001403: (A) information on prevention of exposure to, and the transmission of, the etiologic agent for acquired
p.001403: immune deficiency syndrome; and
p.001403: (B) information contained in the data banks estab- lished in subsections (c) and (d).
p.001403: (c) DATA BANK ON RESEARCH INFORMATION.—
p.001403: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001403:
p.001403:
p.001403:
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p.001403:
p.001403:
p.001405: 1405
p.001405: PUBLIC HEALTH SERVICE ACT
p.001405: Sec. 2317
p.001405:
p.001405: (1) After consultation with the Director of the Office of AIDS Research, the Director of the Centers for
p.001405: Disease Control and Prevention, and the National Library of Medicine, the Sec- retary shall establish a data bank of
p.001405: information on the results of research with respect to acquired immune deficiency syn- drome conducted in the
p.001405: United States and other countries.
p.001405: (2) In carrying out paragraph (1), the Secretary shall col- lect, catalog, store, and disseminate the
p.001405: information described in such paragraph. To the extent practicable, the Secretary shall make such
p.001405: information available to researchers, physi- cians, and other appropriate individuals, of countries other
p.001405: than the United States.
p.001405: (d) DATA BANK ON CLINICAL TRIALS AND TREATMENTS.—
p.001405: (1) After consultation with the Commissioner of Food and Drugs, the AIDS Research Advisory Committee
...

p.001413: institution, as may be necessary to expedite and coordinate re- search relating to acquired immune deficiency syndrome.
p.001413: (b) PROJECTS FOR COOPERATION AMONG PUBLIC AND PRIVATE HEALTH ENTITIES.—In carrying out subsection (a), the
p.001413: Director of the Office shall establish projects to promote cooperation among Federal agencies, State,
p.001413: local, and regional public health agencies, and private entities, in research concerning the diagnosis,
p.001413: preven- tion, and treatment of acquired immune deficiency syndrome.
p.001413: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001413:
p.001413:
p.001413:
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p.001413:
p.001415: 1415
p.001415: PUBLIC HEALTH SERVICE ACT
p.001415: Sec. 2356
p.001415:
p.001415:
p.001415:
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p.001415:
p.001415:
p.001415: January 30, 2020
p.001415: Subpart II—Emergency Discretionary Fund
p.001415: SEC. 2356. ø300cc–43¿ EMERGENCY DISCRETIONARY FUND.
p.001415: (a) IN GENERAL.—
p.001415: (1) ESTABLISHMENT.—There is established a fund con- sisting of such amounts as may be appropriated
p.001415: under sub- section (g). Subject to the provisions of this section, the Direc- tor of the Office, after
p.001415: consultation with the advisory council established under section 2352, may expend amounts in the Fund for
p.001415: the purpose of conducting and supporting such AIDS activities, including projects of AIDS research, as may be
p.001415: au- thorized in this Act for the National Institutes of Health.
p.001415: (2) PRECONDITIONS TO USE OF FUND.—Amounts in the Fund may be expended only if—
p.001415: (A) the Director identifies the particular set of AIDS activities for which such amounts are to be expended;
p.001415: (B) the set of activities so identified constitutes either a new project or additional AIDS activities for an existing
p.001415: project;
p.001415: (C) the Director of the Office has made a determina- tion that there is a significant need for such
p.001415: set of activi- ties; and
p.001415: (D) as of June 30 of the fiscal year preceding the fiscal year in which the determination is made, such need
p.001415: was not provided for in any appropriations Act passed by the House of Representatives to make
p.001415: appropriations for the Departments of Labor, Health and Human Services (in- cluding the National Institutes of
p.001415: Health), Education, and related agencies for the fiscal year in which the determina- tion is made.
p.001415: (3) TWO-YEAR USE OF FUND FOR PROJECT INVOLVED.—In the case of an identified set of AIDS
...

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p.001425:
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p.001427: 1427
p.001427: PUBLIC HEALTH SERVICE ACT
p.001427: Sec. 2421
p.001427:
p.001427: PART B—SUBACUTE CARE
p.001427: SEC. 2421. ø300dd–21¿ DEMONSTRATION PROJECTS.
p.001427: (a) As used in this section:
p.001427: (1) The term ‘‘individuals infected with the etiologic agent for acquired immune deficiency syndrome’’ means
p.001427: individuals who have a disease, or are recovering from a disease, attrib- utable to the infection of
p.001427: such individuals with such etiologic agent, and as a result of the effects of such disease, are in need of
p.001427: subacute-care services.
p.001427: (2) The term ‘‘subacute care’’ means medical and health care services that are required for individuals
p.001427: recovering from acute care episodes that are less intensive than the level of care provided in
p.001427: acute-care hospitals, and includes skilled nursing care, hospice care, and other types of health
p.001427: services provided in other long-term-care facilities.
p.001427: (b) The Secretary shall conduct three demonstration projects to determine the effectiveness and cost of providing the
p.001427: subacute-care services described in subsection (b) to individuals infected with the etiologic agent for acquired
p.001427: immune deficiency syndrome, and the impact of such services on the health status of such individuals.
p.001427: (c)(1) The services provided under each demonstration project shall be designed to meet the specific needs of
p.001427: individuals infected with the etiologic agent for acquired immune deficiency syndrome, and shall include—
p.001427: (A) the care and treatment of such individuals by pro- viding—
p.001427: (i) subacute care;
p.001427: (ii) emergency medical care and specialized diagnostic and therapeutic services as needed and where appropriate,
p.001427: either directly or through affiliation with a hospital that has experience in treating individuals with
p.001427: acquired im- mune deficiency syndrome; and
p.001427: (iii) case management services to ensure, through ex- isting services and programs whenever possible,
p.001427: appro- priate discharge planning for such individuals; and
p.001427: (B) technical assistance, to other facilities in the region served by such facility, that is directed
p.001427: toward education and training of physicians, nurses, and other health-care profes- sionals in the subacute
p.001427: care and treatment of individuals in- fected with the etiologic agent for acquired immune deficiency
p.001427: syndrome.
p.001427: (2) Services provided under each demonstration project may also include—
p.001427: (A) hospice services;
p.001427: (B) outpatient care; and
p.001427: (C) outreach activities in the surrounding community to hospitals and other health-care facilities that serve
p.001427: individuals infected with the etiologic agent for acquired immune defi- ciency syndrome.
p.001427: (d) The demonstration projects shall be conducted—
p.001427:
p.001427: January 30, 2020 As Amended Through P.L. 116-94,
p.001427: Enacted December 20, 2019
p.001427:
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p.001431: syndrome;
p.001431:
p.001431:
p.001431:
p.001431: January 30, 2020
p.001431: 1 See footnote at beginning of title XXIII.
p.001431:
p.001431: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001431:
p.001431:
p.001431:
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p.001431: Sec. 2503 PUBLIC HEALTH SERVICE ACT 1432
p.001431:
p.001431: (2) to develop, establish, and conduct such public informa- tion activities for the general public relating to the
p.001431: prevention and diagnosis of such syndrome;
p.001431: (3) to develop, establish, and conduct activities to reduce risks relating to such syndrome, including
p.001431: research into the prevention of such syndrome;
p.001431: (4) to conduct demonstration projects for the prevention of such syndrome;
p.001431: (5) to provide technical assistance to public entities, to nonprofit private entities concerned with such
p.001431: syndrome, to schools, and to employers, for the purpose of developing infor- mation programs relating to such
p.001431: syndrome;
p.001431: (6) with respect to education and training programs for the prevention of such syndrome, to conduct such
p.001431: programs for health professionals (including allied health professionals), public safety workers
p.001431: (including emergency response employ- ees), teachers, school administrators, and other appropriate education
p.001431: personnel;
p.001431: (7) to conduct appropriate programs for educating school- aged children with respect to such syndrome,
p.001431: after consulting with local school boards;
p.001431: (8) to make available to physicians and dentists in the State information with respect to acquired
p.001431: immune deficiency syndrome, including measures for the prevention of exposure to, and the transmission of,
p.001431: the etiologic agent for such syn- drome (which information is updated not less than annually with the
p.001431: most recently available scientific date 2 relating to such syndrome);
p.001431: (9) to carry out the initial implementation of recommenda- tions contained in the guidelines and the model curriculum
p.001431: de- veloped under section 253 of the AIDS Amendments of 1988; and
p.001431: (10) to make grants to public entities, and to nonprofit pri- vate entities concerned with acquired immune
p.001431: deficiency syn- drome, for the purpose of the development, establishment, and expansion of programs for education
p.001431: directed toward individ- uals at increased risk of infection with the etiologic agent for such syndrome and
p.001431: activities to reduce the risks of exposure to such etiologic agent, with preference to programs directed to-
p.001431: ward populations in which there is significant evidence of such infection.
p.001431: SEC. 2503. ø300ee–13¿ REQUIREMENT OF SUBMISSION OF APPLICATION CONTAINING CERTAIN AGREEMENTS AND ASSURANCES.
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p.001441: Sec. 2524 PUBLIC HEALTH SERVICE ACT 1442
p.001441:
p.001441: SEC. 2524. ø300ee–34¿ AUTHORIZATION OF APPROPRIATIONS.
p.001441: (a) IN GENERAL.—For the purpose of carrying out sections 2521 through 2523, there are authorized to
p.001441: be appropriated
p.001441: $105,000,000 for fiscal year 1989 and such sums as may be nec- essary for each of the fiscal years 1990 and
p.001441: 1991.
p.001441: (b) ALLOCATIONS.—
p.001441: (1) Of the amounts appropriated pursuant to subsection (a), the Secretary shall make available $45,000,000 to
p.001441: carry out section 2522 and $30,000,000 to carry out this part through fi- nancial assistance to minority entities for
p.001441: the provision of serv- ices to minority populations.
p.001441: (2) After consultation with the Director of the Office of Mi- nority Health and with the Indian Health Service,
p.001441: the Sec- retary, acting through the Director of the Centers for Disease Control and Prevention, shall, not
p.001441: later than 90 days after the date of the enactment of the AIDS Amendments of 1988, 6 pub- lish guidelines to
p.001441: provide procedures for applications for fund- ing pursuant to paragraph (1) and for public comment.
p.001441:
p.001441: TITLE XXVI—HIV HEALTH CARE SERVICES PROGRAM 1
p.001441: PART A—EMERGENCY RELIEF FOR AREAS WITH SUBSTANTIAL NEED
p.001441: FOR SERVICES 2
p.001441: Subpart I—General Grant Provisions
p.001441: SEC. 2601. ø300ff–11¿ ESTABLISHMENT OF PROGRAM OF GRANTS.
p.001441: (a) ELIGIBLE AREAS.—The Secretary, acting through the Ad- ministrator of the Health Resources and Services
p.001441: Administration, shall, subject to subsections (b) through (c), make grants in accord- ance with section 2603 for the
p.001441: purpose of assisting in the provision of the services specified in section 2604 in any metropolitan area for
p.001441: which there has been reported to and confirmed by the Director of the Centers for Disease Control and Prevention
p.001441: a cumulative total of more than 2,000 cases of AIDS during the most recent pe- riod of 5 calendar years for which
p.001441: such data are available.
p.001441: (b) CONTINUED STATUS AS ELIGIBLE AREA.—Notwithstanding any other provision of this section, a
p.001441: metropolitan area that is an eligible area for a fiscal year continues to be an eligible area until the
p.001441: metropolitan area fails, for three consecutive fiscal years—
p.001441:
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p.001441:
p.001441: January 30, 2020
p.001441: 6 Enacted on November 4, 1988.
p.001441: 1 This title was added by Public Law 101–381. Section 2 of that Public Law provides as fol- lows: ‘‘It
p.001441: is the purpose of this Act to provide emergency assistance to localities that are dis- proportionately
p.001441: affected by the Human Immunodeficiency Virus epidemic and to make financial assistance available to States and
p.001441: other public or private nonprofit entities to provide for the development, organization, coordination and
p.001441: operation of more effective and cost efficient sys- tems for the delivery of essential services to individuals
p.001441: and families with HIV disease.’’.
p.001441: 2 Section 502 of Public Law 106–345 (114 Stat. 1353) relates to the development of reliable and
p.001441: affordable tests for HIV disease that can rapidly be administered and whose results can rapidly be
p.001441: obtained.
p.001441: With respect to information for determining formula grants under parts A and B, section 501(a) of Public
p.001441: Law 106–345 (114 Stat. 1352) provides for a study of State surveillance systems regarding cases of infection with
p.001441: the human immunodeficiency virus. Section 501(d)(1) of such Law requires that a report of the findings of the
p.001441: study be submitted not later than 3 years after the date of the enactment of the Law, which was enacted October 20,
p.001441: 2000.
p.001441: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001443: PUBLIC HEALTH SERVICE ACT
p.001443: Sec. 2602
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p.001453: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1454
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p.001453: January 30, 2020
p.001453:
p.001453: section for the fiscal year, other than grants for eligi- ble areas for which increases under
p.001453: subparagraph (A) apply. A reduction under the preceding sentence may not be made in an amount that would result
p.001453: in the eli- gible area involved becoming eligible for such an in- crease.
p.001453: (C) LIMITATION.—This paragraph may not be con- strued as having any applicability after fiscal year 2013.
p.001453: (b) SUPPLEMENTAL GRANTS.—
p.001453: (1) IN GENERAL.—Subject to subsection (a)(4)(B)(i) and sec- tion 2610(d), the Secretary shall disburse the
p.001453: remainder of amounts not disbursed under section 2603(a)(2) for such fiscal year for the purpose of making grants
p.001453: under section 2601(a) to eligible areas whose application under section 2605(b)—
p.001453: (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) and the
p.001453: plan for utilization of such funds;
p.001453: (B) demonstrates the need in such area, on an objec- tive and quantified basis, for supplemental financial
p.001453: assist- ance to combat the HIV epidemic;
p.001453: (C) demonstrates the existing commitment of local re- sources of the area, both financial and in-kind, to com-
p.001453: bating the HIV epidemic;
p.001453: (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is
p.001453: im- mediately responsive and cost effective;
p.001453: (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of
p.001453: AIDS including appropriate allocations for services for infants, children, youth, women, and families with
p.001453: HIV/AIDS;
p.001453: (F) demonstrates the inclusiveness of affected commu- nities and individuals with HIV/AIDS;
p.001453: (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment
p.001453: and the statewide coordinated statement of need;
p.001453: (H) demonstrates the ability of the applicant to expend funds efficiently by not having had, for the most
p.001453: recent grant year under subsection (a) for which data is available, more than 5 percent of grant funds under such
...

p.001459: (M) Medical case management, including treatment adherence services.
p.001459: (d) SUPPORT SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘support services’’ means services, subject to
p.001459: the approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical
p.001459: outcomes (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001459: transportation, linguistic services, and referrals for health care and support services).
p.001459: (2) MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes affecting
p.001459: the HIV- related clinical status of an individual with HIV/AIDS.
p.001459: (e) EARLY INTERVENTION SERVICES.—
p.001459: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001459: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001459: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001459: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001459: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001459: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001459: of entry specified by
p.001459: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001459:
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p.001461: 1461
p.001461: PUBLIC HEALTH SERVICE ACT
p.001461: Sec. 2604
p.001461:
p.001461: eligible areas, federally qualified health centers, and entities described in section 2652(a) that constitute a
p.001461: point of access to services by maintaining referral relationships.
p.001461: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001461: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the chief
p.001461: elected official for the eligible area involved that—
p.001461: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001461: entity pro- poses to provide; and
p.001461: (B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds
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p.001463: (C) that political subdivisions within the eligible area will not use funds received under a grant awarded
p.001463: under this sub- part in maintaining the level of expenditures for HIV-related services as required in
p.001463: subparagraph (B);
p.001463: (2) that the eligible area has an HIV health services plan- ning council and has entered into intergovernmental
p.001463: agree- ments pursuant to section 2602, and has developed or will de- velop the comprehensive plan in
p.001463: accordance with section 2602(b)(3)(B);
p.001463: (3) that entities within the eligible area that receive funds under a grant under this subpart will maintain
p.001463: appropriate re- lationships with entities in the eligible area served that con- stitute key points of access
p.001463: to the health care system for indi- viduals with HIV/AIDS (including emergency rooms, substance abuse treatment
p.001463: programs, detoxification centers, adult and ju- venile detention facilities, sexually transmitted disease clinics, HIV
p.001463: counseling and testing sites, mental health programs, and homeless shelters), and other entities under section
p.001463: 2604(b)(3) and 2652(a), for the purpose of facilitating early intervention for individuals newly diagnosed
p.001463: with HIV/AIDS and individ- uals knowledgeable of their HIV status but not in care;
p.001463: (4) that the chief elected official of the eligible area will satisfy all requirements under section 2604(c);
p.001463: (5) that entities within the eligible area that will receive funds under a grant provided under section
p.001463: 2601(a) shall par- ticipate in an established HIV community-based continuum of care if such continuum exists
p.001463: within the eligible area;
p.001463: (6) that funds received under a grant awarded under this subpart will not be utilized to make payments for any
p.001463: item or service to the extent that payment has been made, or can rea- sonably be expected to be made, with
p.001463: respect to that item or service—
p.001463: (A) under any State compensation program, under an insurance policy, or under any Federal or State
p.001463: health benefits program (except for a program administered by or providing the services of the Indian Health Service);
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p.001473:
p.001473:
p.001473:
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p.001473:
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p.001473: January 30, 2020
p.001473:
p.001473: (M) Medical case management, including treatment adherence services.
p.001473: (c) SUPPORT SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this subsection, the term ‘‘support services’’ means services, subject to the
p.001473: approval of the Secretary, that are needed for individuals with HIV/AIDS to achieve their medical outcomes
p.001473: (such as respite care for per- sons caring for individuals with HIV/AIDS, outreach services, medical
p.001473: transportation, linguistic services, and referrals for health care and support services).
p.001473: (2) DEFINITION OF MEDICAL OUTCOMES.—In this subsection, the term ‘‘medical outcomes’’ means those outcomes
p.001473: affecting the HIV-related clinical status of an individual with HIV/AIDS.
p.001473: (d) EARLY INTERVENTION SERVICES.—
p.001473: (1) IN GENERAL.—For purposes of this section, the term ‘‘early intervention services’’ means HIV/AIDS
p.001473: early interven- tion services described in section 2651(e), with follow-up refer- ral provided for the purpose of
p.001473: facilitating the access of individ- uals receiving the services to HIV-related health services. The entities through
p.001473: which such services may be provided under the grant include public health departments, emergency rooms, substance
p.001473: abuse and mental health treatment programs, de- toxification centers, detention facilities, clinics regarding
p.001473: sexu- ally transmitted diseases, homeless shelters, HIV/AIDS coun- seling and testing sites, health care points
p.001473: of entry specified by States, federally qualified health centers, and entities de- scribed in section
p.001473: 2652(a) that constitute a point of access to services by maintaining referral relationships.
p.001473: (2) CONDITIONS.—With respect to an entity that proposes to provide early intervention services under
p.001473: paragraph (1), such paragraph shall apply only if the entity demonstrates to the satisfaction of the
p.001473: chief elected official for the State in- volved that—
p.001473: (A) Federal, State, or local funds are otherwise inad- equate for the early intervention services the
p.001473: entity pro- poses to provide; and
p.001473: (B) the entity will expend funds pursuant to such sub- paragraph to supplement and not supplant other funds
p.001473: available to the entity for the provision of early interven- tion services for the fiscal year involved.
p.001473: (e) PRIORITY FOR WOMEN, INFANTS, CHILDREN, AND YOUTH.—
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p.001483: January 30, 2020
p.001483:
p.001483: health and support services provided by entities that re- ceive funds from the State under section 2611;
p.001483: (D) the State will permit and cooperate with any Fed- eral investigations undertaken regarding programs con-
p.001483: ducted under section 2611;
p.001483: (E) the State will maintain HIV-related activities at a level that is equal to not less than the level of
p.001483: such ex- penditures by the State for the 1-year period preceding the fiscal year for which the State is
p.001483: applying to receive a grant under section 2611;
p.001483: (F) the State will ensure that grant funds are not uti- lized to make payments for any item or service to the
p.001483: ex- tent that payment has been made, or can reasonably be ex- pected to be made, with respect to that item or
p.001483: service—
p.001483: (i) under any State compensation program, under an insurance policy, or under any Federal or State health
p.001483: benefits program; or
p.001483: (ii) by an entity that provides health services on a prepaid basis (except for a program administered by or
p.001483: providing the services of the Indian Health Service); and
p.001483: (G) entities within areas in which activities under the grant are carried out will maintain appropriate
p.001483: relation- ships with entities in the area served that constitute key points of access to the health care
p.001483: system for individuals with HIV/AIDS (including emergency rooms, substance abuse treatment programs,
p.001483: detoxification centers, adult and juvenile detention facilities, sexually transmitted dis- ease clinics,
p.001483: HIV counseling and testing sites, mental health programs, and homeless shelters), and other enti- ties
p.001483: under section 2612(c) and 2652(a), for the purpose of facilitating early intervention for individuals
p.001483: newly diag- nosed with HIV/AIDS and individuals knowledgeable of their HIV status but not in care; and
p.001483: (8) a comprehensive plan—
p.001483: (A) containing an identification of individuals with HIV/AIDS as described in clauses (i) through (iii) of
p.001483: section 2603(b)(2)(A) and the strategy required under section 2602(b)(4)(D)(iv);
p.001483: (B) describing the estimated number of individuals within the State with HIV/AIDS who do not know their
p.001483: status;
p.001483: (C) describing activities undertaken by the State to find the individuals described in subparagraph (A)
p.001483: and to make such individuals aware of their status;
p.001483: (D) describing the manner in which the State will pro- vide undiagnosed individuals who are made aware of their status
p.001483: with access to medical treatment for their HIV/ AIDS; and
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p.001513: individual may have exposed to HIV/AIDS, hepatitis B, or hepatitis C; and
p.001513: (ii) that emphasizes it is the duty of infected individ- uals to disclose their infected status to
p.001513: their sexual part- ners and their partners in the sharing of hypodermic nee- dles; that provides advice to
p.001513: infected individuals on the manner in which such disclosures can be made; and that emphasizes that it is
p.001513: the continuing duty of the individ- uals to avoid any behaviors that will expose others to HIV/ AIDS, hepatitis
p.001513: B, or hepatitis C; and
p.001513: (D) on the availability of the services of public health authorities with respect to locating and counseling
p.001513: any in- dividual described in subparagraph (C);
p.001513: (4) if diagnosed with chronic hepatitis B or hepatitis C co- infection, the potential of developing hepatitis-related
p.001513: liver dis- ease and its impact on HIV/AIDS; and
p.001513: (5) information regarding the availability of hepatitis B vaccine.
p.001513: (c) ADDITIONAL REQUIREMENTS REGARDING APPROPRIATE COUN- SELING.—The Secretary may not make a grant under this part
p.001513: un- less the applicant for the grant agrees that, in counseling individ- uals with respect to HIV/AIDS,
p.001513: the applicant will ensure that the counseling is provided under conditions appropriate to the needs of the
p.001513: individuals.
p.001513: (d) COUNSELING OF EMERGENCY RESPONSE EMPLOYEES.—The Secretary may not make a grant under this part to a State
p.001513: unless the State agrees that, in counseling individuals with respect to HIV/AIDS, the State will ensure that,
p.001513: in the case of emergency re- sponse employees, the counseling is provided to such employees under conditions
p.001513: appropriate to the needs of the employees regard- ing the counseling.
p.001513: (e) RULE OF CONSTRUCTION REGARDING COUNSELING WITHOUT TESTING.—Agreements made pursuant to this section may
p.001513: not be construed to prohibit any grantee under this part from expending the grant for the purpose of
p.001513: providing counseling services described in this section to an individual who does not undergo testing for
p.001513: HIV/AIDS as a result of the grantee or the individual determining that such testing of the individual is not
p.001513: appropriate.
p.001513: SEC. 2663. ø300ff–63¿ APPLICABILITY OF REQUIREMENTS REGARDING CONFIDENTIALITY, INFORMED CONSENT, AND
p.001513: COUN- SELING.
p.001513: The Secretary may not make a grant under this part unless the applicant for the grant agrees that,
p.001513: with respect to testing for HIV/AIDS, any such testing carried out by the applicant with funds
p.001513: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001513:
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p.001513: Sec. 2664 PUBLIC HEALTH SERVICE ACT 1514
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p.001521: that the continuity of care and prevention services of individuals with HIV/ AIDS is enhanced.
p.001521: (d) INTEGRATION BY LOCAL OR PRIVATE ENTITIES.—As a condi- tion of receipt of funds under this title, a
p.001521: local government or pri- vate nonprofit entity shall provide assurances to the Secretary that services funded
p.001521: under this title will be integrated with other such services, that programs will be coordinated with
p.001521: other available programs (including Medicaid), and that the continuity of care and prevention services of individuals
p.001521: with HIV is enhanced.
p.001521: SEC. 2682. ø300ff–82¿ AUDITS.
p.001521: (a) IN GENERAL.—For fiscal year 2009, and each subsequent fiscal year, the Secretary may reduce the amounts of
p.001521: grants under this title to a State or political subdivision of a State for a fiscal year if, with
p.001521: respect to such grants for the second preceding fiscal year, the State or subdivision fails to prepare audits
p.001521: in accordance with the procedures of section 7502 of title 31, United States Code. The Secretary shall annually select
p.001521: representative samples of such audits, prepare summaries of the selected audits, and submit the summaries to
p.001521: the Congress.
p.001521: (b) POSTING ON THE INTERNET.—All audits that the Secretary receives from the State lead agency under
p.001521: section 2617(b)(4) shall be posted, in their entirety, on the Internet website of the Health Resources and
p.001521: Services Administration.
p.001521: SEC. 2683. ø300ff–83¿ PUBLIC HEALTH EMERGENCY.
p.001521: (a) IN GENERAL.—In an emergency area and during an emer- gency period, the Secretary shall have the authority
p.001521: to waive such requirements of this title to improve the health and safety of those receiving care under this title
p.001521: and the general public, except that the Secretary may not expend more than 5 percent of the funds al- located
p.001521: under this title for sections 2620 and section 2603(b).
p.001521: (b) EMERGENCY AREA AND EMERGENCY PERIOD.—In this sec- tion:
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001521:
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p.001521: Sec. 2684 PUBLIC HEALTH SERVICE ACT 1522
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p.001521: January 30, 2020
p.001521:
p.001521: (1) EMERGENCY AREA.—The term ‘‘emergency area’’ means a geographic area in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (2) EMERGENCY PERIOD.—The term ‘‘emergency period’’ means the period in which there exists—
p.001521: (A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T.
p.001521: Stafford Disaster Relief and Emergency Assistance Act; or
p.001521: (B) a public health emergency declared by the Sec- retary pursuant to section 319.
p.001521: (c) UNOBLIGATED FUNDS.—If funds under a grant under this section are not expended for an emergency in
p.001521: the fiscal year in which the emergency is declared, such funds shall be returned to the Secretary for
p.001521: reallocation under sections 2603(b) and 2620.
p.001521: SEC. 2684. ø300ff–84¿ PROHIBITION ON PROMOTION OF CERTAIN AC- TIVITIES.
p.001521: None of the funds appropriated under this title shall be used to fund AIDS programs, or to develop
p.001521: materials, designed to pro- mote or encourage, directly, intravenous drug use or sexual activ- ity,
p.001521: whether homosexual or heterosexual. Funds authorized under this title may be used to provide medical
p.001521: treatment and support services for individuals with HIV.
p.001521: SEC. 2685. ø300ff–85¿ PRIVACY PROTECTIONS.
p.001521: (a) IN GENERAL.—The Secretary shall ensure that any informa- tion submitted to, or collected by, the Secretary under
p.001521: this title ex- cludes any personally identifiable information.
p.001521: (b) DEFINITION.—In this section, the term ‘‘personally identifi- able information’’ has the meaning given such
p.001521: term under the regu- lations promulgated under section 264(c) of the Health Insurance Portability and
p.001521: Accountability Act of 1996.
p.001521: SEC. 2686. ø300ff–86¿ GAO REPORT.
p.001521: The Comptroller General of the Government Accountability Of- fice shall, not less than 1 year after the date
p.001521: of enactment of the Ryan White HIV/AIDS Treatment Extension Act of 2009, submit to the appropriate committees of
p.001521: Congress a report describing Minor- ity AIDS Initiative activities across the Department of Health and Human Services,
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p.001529: January 30, 2020
p.001529: SEC. 2693. ø300ff–121¿ MINORITY AIDS INITIATIVE.
p.001529: (a) IN GENERAL.—For the purpose of carrying out activities under this section to evaluate and address the
p.001529: disproportionate im- pact of HIV/AIDS on, and the disparities in access, treatment, care, and outcomes for, racial
p.001529: and ethnic minorities (including African Americans, Alaska Natives, Latinos, American Indians, Asian
p.001529: Americans, Native Hawaiians, and Pacific Islanders), there are au- thorized to be appropriated $131,200,000
p.001529: for fiscal year 2007,
p.001529: $135,100,000 for fiscal year 2008, $139,100,000 for fiscal year 2009,
p.001529: $146,055,000 for fiscal year 2010, $153,358,000 for fiscal year 2011,
p.001529: $161,026,000 for fiscal year 2012, and $169,077,000 for fiscal year 2013. The Secretary shall develop a
p.001529: formula for the awarding of grants under subsections (b)(1)(A) and (b)(1)(B) that ensures that funding is
p.001529: provided based on the distribution of populations dis- proportionately impacted by HIV/AIDS.
p.001529: (b) CERTAIN ACTIVITIES.—
p.001529: (1) IN GENERAL.—In carrying out the purpose described in subsection (a), the Secretary shall provide for—
p.001529: (A) emergency assistance under part A;
p.001529: (B) care grants under part B;
p.001529: (C) early intervention services under part C;
p.001529: (D) services through projects for HIV-related care under part D; and
p.001529: (E) activities through education and training centers under section 2692.
p.001529: (2) ALLOCATIONS AMONG ACTIVITIES.—Activities under paragraph (1) shall be carried out by the
p.001529: Secretary in accord- ance with the following:
p.001529: (A) For supplemental grants to improve HIV-related health outcomes to reduce existing racial and ethnic health
p.001529: disparities, the Secretary shall, of the amount appro- priated under subsection (a) for a fiscal
p.001529: year, reserve the following, as applicable:
p.001529: (i) For fiscal year 2007, $43,800,000.
p.001529: (ii) For fiscal year 2008, $45,400,000.
p.001529: (iii) For fiscal year 2009, $47,100,000.
p.001529: (iv) For fiscal year 2010, $46,738,000. (v) For fiscal year 2011, $49,075,000.
p.001529: (vi) For fiscal year 2012, $51,528,000.
p.001529: (vii) For fiscal year 2013, $54,105,000.
p.001529: (B) For grants used for supplemental support edu- cation and outreach services to increase the number of eli-
p.001529: gible racial and ethnic minorities who have access to treat- ment through the program under section 2616 for
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p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
p.001529: Secretary pursuant to the Departments of Labor, Health and Human Services, and Education, and Related
p.001529: Agencies Appropriations Act, 2002 (Public Law 107–116).
p.001529: (d) SYNCHRONIZATION OF MINORITY AIDS INITIATIVE.—For fis- cal year 2010 and each subsequent fiscal year, the
p.001529: Secretary shall incorporate and synchronize the schedule of application submis- sions and funding availability
p.001529: under this section with the schedule of application submissions and funding availability under the cor-
p.001529: responding provisions of this title XXVI as follows:
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001531: 1531
p.001531: PUBLIC HEALTH SERVICE ACT
p.001531: Sec. 2695A
p.001531:
p.001531: (1) The schedule for carrying out subsection (b)(1)(A) shall be the same as the schedule applicable to emergency
p.001531: assistance under part A.
p.001531: (2) The schedule for carrying out subsection (b)(1)(B) shall be the same as the schedule applicable to care
p.001531: grants under part B.
p.001531: (3) The schedule for carrying out subsection (b)(1)(C) shall be the same as the schedule applicable to grants
p.001531: for early intervention services under part C.
p.001531: (4) The schedule for carrying out subsection (b)(1)(D) shall be the same as the schedule applicable to grants
p.001531: for services through projects for HIV-related care under part D.
p.001531: (5) The schedule for carrying out subsection (b)(1)(E) shall be the same as the schedule applicable to grants and
p.001531: contracts for activities through education and training centers under sec- tion 2692.
p.001531:
p.001531: PART G—NOTIFICATION OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES
p.001531:
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p.001531: January 30, 2020
p.001531: SEC. 2695. ø300ff–131¿ INFECTIOUS DISEASES AND CIRCUMSTANCES RELEVANT TO NOTIFICATION REQUIREMENTS.
p.001531: (a) IN GENERAL.—Not later than 180 days after the date of the enactment of this part, the Secretary shall
p.001531: complete the develop- ment of—
p.001531: (1) a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which
p.001531: emergency re- sponse employees may be exposed in responding to emer- gencies;
p.001531: (2) guidelines describing the circumstances in which such employees may be exposed to such diseases,
p.001531: taking into ac- count the conditions under which emergency response is pro- vided; and
p.001531: (3) guidelines describing the manner in which medical fa- cilities should make determinations for purposes
p.001531: of section 2695B(d).
p.001531: (b) SPECIFICATION OF AIRBORNE INFECTIOUS DISEASES.—The list developed by the Secretary under subsection (a)(1)
p.001531: shall include a specification of those infectious diseases on the list that are rou- tinely transmitted through
p.001531: airborne or aerosolized means.
p.001531: (c) DISSEMINATION.—The Secretary shall—
p.001531: (1) transmit to State public health officers copies of the list and guidelines developed by the Secretary under
p.001531: subsection (a) with the request that the officers disseminate such copies as appropriate throughout the
p.001531: States; and
p.001531: (2) make such copies available to the public.
p.001531: SEC. 2695A. ø300ff–132¿ ROUTINE NOTIFICATIONS WITH RESPECT TO AIRBORNE INFECTIOUS DISEASES IN VICTIMS ASSISTED.
p.001531: (a) ROUTINE NOTIFICATION OF DESIGNATED OFFICER.—
p.001531: (1) DETERMINATION BY TREATING FACILITY.—If a victim of an emergency is transported by emergency response
p.001531: employees to a medical facility and the medical facility makes a deter- mination that the victim has an
p.001531: airborne infectious disease,
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001531: Sec. 2695B PUBLIC HEALTH SERVICE ACT 1532
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p.001531: January 30, 2020
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p.001531: the medical facility shall notify the designated officer of the emergency response employees who
p.001531: transported the victim to the medical facility of the determination.
p.001531: (2) DETERMINATION BY FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim of an emergency is transported
p.001531: by emer- gency response employees to a medical facility and the victim dies at or before reaching the
p.001531: medical facility, the medical fa- cility ascertaining the cause of death shall notify the des- ignated
p.001531: officer of the emergency response employees who trans- ported the victim to the initial medical facility of
p.001531: any deter- mination by the medical facility that the victim had an air- borne infectious disease.
p.001531: (b) REQUIREMENT OF PROMPT NOTIFICATION.—With respect to a determination described in paragraph (1) or (2) of
p.001531: subsection (a), the notification required in each of such paragraphs shall be made as soon as is practicable, but not
p.001531: later than 48 hours after the de- termination is made.
p.001531: SEC. 2695B. ø300ff–133¿ REQUEST FOR NOTIFICATION WITH RESPECT TO VICTIMS ASSISTED.
p.001531: (a) INITIATION OF PROCESS BY EMPLOYEE.—If an emergency re- sponse employee believes that the employee may
p.001531: have been ex- posed to an infectious disease by a victim of an emergency who was transported to a medical facility as
p.001531: a result of the emergency, and if the employee attended, treated, assisted, or transported the vic- tim
p.001531: pursuant to the emergency, then the designated officer of the employee shall, upon the request of the
p.001531: employee, carry out the du- ties described in subsection (b) regarding a determination of wheth- er the employee may
p.001531: have been exposed to an infectious disease by the victim.
p.001531: (b) INITIAL DETERMINATION BY DESIGNATED OFFICER.—The du- ties referred to in subsection (a) are that—
p.001531: (1) the designated officer involved collect the facts relating to the circumstances under which, for purposes of
p.001531: subsection (a), the employee involved may have been exposed to an infec- tious disease; and
p.001531: (2) the designated officer evaluate such facts and make a determination of whether, if the victim involved had
p.001531: any infec- tious disease included on the list issued under paragraph (1) of section 2695(a), the employee
p.001531: would have been exposed to the disease under such facts, as indicated by the guidelines issued under
p.001531: paragraph (2) of such section.
p.001531: (c) SUBMISSION OF REQUEST TO MEDICAL FACILITY.—
p.001531: (1) IN GENERAL.—If a designated officer makes a deter- mination under subsection (b)(2) that an emergency
p.001531: response employee may have been exposed to an infectious disease, the designated officer shall submit to the
p.001531: medical facility to which the victim involved was transported a request for a response under subsection (d)
p.001531: regarding the victim of the emergency in- volved.
p.001531: (2) FORM OF REQUEST.—A request under paragraph (1) shall be in writing and be signed by the designated
p.001531: officer in- volved, and shall contain a statement of the facts collected pur- suant to subsection (b)(1).
p.001531: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: 1533
p.001533: PUBLIC HEALTH SERVICE ACT
p.001533: Sec. 2695B
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p.001533: January 30, 2020
p.001533: (d) EVALUATION AND RESPONSE REGARDING REQUEST TO MED-
p.001533: ICAL FACILITY.—
p.001533: (1) IN GENERAL.—If a medical facility receives a request under subsection (c), the medical facility shall
p.001533: evaluate the facts submitted in the request and make a determination of whether, on the basis of the medical
p.001533: information possessed by the facility regarding the victim involved, the emergency re- sponse employee was
p.001533: exposed to an infectious disease included on the list issued under paragraph (1) of section 2695(a), as in- dicated by
p.001533: the guidelines issued under paragraph (2) of such section.
p.001533: (2) NOTIFICATION OF EXPOSURE.—If a medical facility makes a determination under paragraph (1) that
p.001533: the emer- gency response employee involved has been exposed to an in- fectious disease, the medical facility
p.001533: shall, in writing, notify the designated officer who submitted the request under subsection
p.001533: (c) of the determination.
p.001533: (3) FINDING OF NO EXPOSURE.—If a medical facility makes a determination under paragraph (1) that the
p.001533: emergency re- sponse employee involved has not been exposed to an infectious disease, the medical facility shall,
p.001533: in writing, inform the des- ignated officer who submitted the request under subsection (c) of the determination.
p.001533: (4) INSUFFICIENT INFORMATION.—
p.001533: (A) If a medical facility finds in evaluating facts for purposes of paragraph (1) that the facts are
p.001533: insufficient to make the determination described in such paragraph, the medical facility shall, in writing,
p.001533: inform the designated of- ficer who submitted the request under subsection (c) of the insufficiency of the facts.
p.001533: (B)(i) If a medical facility finds in making a deter- mination under paragraph (1) that the facility possesses
p.001533: no information on whether the victim involved has an infec- tious disease included on the list under
p.001533: section 2695(a), the medical facility shall, in writing, inform the designated officer who submitted the request
p.001533: under subsection (c) of the insufficiency of such medical information.
p.001533: (ii) If after making a response under clause (i) a med- ical facility determines that the victim involved has an in-
p.001533: fectious disease, the medical facility shall make the deter- mination described in paragraph (1) and provide the appli-
p.001533: cable response specified in this subsection.
p.001533: (e) TIME FOR MAKING RESPONSE.—After receiving a request under subsection (c) (including any such request
p.001533: resubmitted under subsection (g)(2)), a medical facility shall make the applicable re- sponse specified in
p.001533: subsection (d) as soon as is practicable, but not later than 48 hours after receiving the request.
p.001533: (f) DEATH OF VICTIM OF EMERGENCY.—
p.001533: (1) FACILITY ASCERTAINING CAUSE OF DEATH.—If a victim described in subsection (a) dies at or before reaching the
p.001533: med- ical facility involved, and the medical facility receives a request under subsection (c), the medical
p.001533: facility shall provide a copy of the request to the medical facility ascertaining the cause of
p.001533: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001533: death of the victim, if such facility is a different medical facil- ity than the facility that received the original
p.001533: request.
p.001533: (2) RESPONSIBILITY OF FACILITY.—Upon the receipt of a copy of a request for purposes of paragraph (1), the
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p.001533: (i) the public health officer shall provide advice to the designated officer regarding the collection and de- scription
p.001533: of appropriate facts; and
p.001533: (ii) if sufficient facts are obtained by the des- ignated officer—
p.001533: (I) the public health officer shall, on behalf of the designated officer involved, resubmit the re- quest to the
p.001533: medical facility; and
p.001533: (II) the medical facility shall provide to the designated officer the appropriate response under subsection
p.001533: (c).
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p.001535: 1535
p.001535: PUBLIC HEALTH SERVICE ACT
p.001535: Sec. 2695E
p.001535:
p.001535: SEC. 2695C. ø300ff–134¿ PROCEDURES FOR NOTIFICATION OF EXPO- SURE.
p.001535: (a) CONTENTS OF NOTIFICATION TO OFFICER.—In making a no- tification required under section 2695A or section
p.001535: 2695B(d)(2), a medical facility shall provide—
p.001535: (1) the name of the infectious disease involved; and
p.001535: (2) the date on which the victim of the emergency involved was transported by emergency response employees to the med-
p.001535: ical facility involved.
p.001535: (b) MANNER OF NOTIFICATION.—If a notification under section 2695A or section 2695B(d)(2) is mailed or
p.001535: otherwise indirectly made—
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p.001535: (1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer
p.001535: to whom the notification is sent of the fact that the notification has been sent; and
p.001535: (2) such designated officer shall, not later than 10 days after being informed by the medical facility
p.001535: that the notifica- tion has been sent, inform such medical facility whether the designated officer has
p.001535: received the notification.
p.001535: SEC. 2695D. ø300ff–135¿ NOTIFICATION OF EMPLOYEE.
p.001535: (a) IN GENERAL.—After receiving a notification for purposes of section 2695A or 2695B(d)(2), a designated officer of
p.001535: emergency re- sponse employees shall, to the extent practicable, immediately no- tify each of such employees
p.001535: who—
p.001535: (1) responded to the emergency involved; and
p.001535: (2) as indicated by guidelines developed by the Secretary, may have been exposed to an infectious disease.
p.001535: (b) CERTAIN CONTENTS OF NOTIFICATION TO EMPLOYEE.—A no- tification under this subsection to an emergency response
p.001535: employee shall inform the employee of—
p.001535: (1) the fact that the employee may have been exposed to an infectious disease and the name of the disease
p.001535: involved;
p.001535: (2) any action by the employee that, as indicated by guide- lines developed by the Secretary, is medically appropriate;
p.001535: and
p.001535: (3) if medically appropriate under such criteria, the date of such emergency.
p.001535: (c) RESPONSES OTHER THAN NOTIFICATION OF EXPOSURE.— After receiving a response under paragraph (3) or (4) of
p.001535: subsection
p.001535: (d) of section 2695B, or a response under subsection (g)(1) of such section, the designated officer for the
p.001535: employee shall, to the extent practicable, immediately inform the employee of the response.
p.001535: SEC. 2695E. ø300ff–136¿ SELECTION OF DESIGNATED OFFICERS.
p.001535: (a) IN GENERAL.—For the purposes of receiving notifications and responses and making requests under this
p.001535: part on behalf of emergency response employees, the public health officer of each State shall designate 1
p.001535: official or officer of each employer of emer- gency response employees in the State.
p.001535: (b) PREFERENCE IN MAKING DESIGNATIONS.—In making the designations required in subsection (a), a public health
p.001535: officer shall give preference to individuals who are trained in the provision of health care or in the
p.001535: control of infectious diseases.
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535: January 30, 2020
p.001535:
p.001535: SEC. 2695F. ø300ff–137¿ LIMITATION WITH RESPECT TO DUTIES OF MEDICAL FACILITIES.
p.001535: The duties established in this part for a medical facility—
p.001535: (1) shall apply only to medical information possessed by the facility during the period in which the
p.001535: facility is treating the victim for conditions arising from the emergency, or during the 60-day period beginning
p.001535: on the date on which the victim is transported by emergency response employees to the facility, whichever period
p.001535: expires first; and
p.001535: (2) shall not apply to any extent after the expiration of the 30-day period beginning on the expiration of the
p.001535: applicable pe- riod referred to in paragraph (1), except that such duties shall apply with respect to any request
p.001535: under section 2695B(c) re- ceived by a medical facility before the expiration of such 30-day period.
p.001535: SEC. 2695G. ø300ff–138¿ MISCELLANEOUS PROVISIONS.
p.001535: (a) LIABILITY OF MEDICAL FACILITIES, DESIGNATED OFFICERS, PUBLIC HEALTH OFFICERS, AND GOVERNING
p.001535: ENTITIES.—This part may not be construed to authorize any cause of action for damages or any civil penalty against any
p.001535: medical facility, any designated of- ficer, any other public health officer, or any governing entity of such
p.001535: facility or officer for failure to comply with the duties estab- lished in this part.
p.001535: (b) TESTING.—This part may not, with respect to victims of emergencies, be construed to authorize or require a
p.001535: medical facility to test any such victim for any infectious disease.
p.001535: (c) CONFIDENTIALITY.—This part may not be construed to au- thorize or require any medical facility, any
p.001535: designated officer of emergency response employees, or any such employee, to disclose identifying information
p.001535: with respect to a victim of an emergency or with respect to an emergency response employee.
p.001535: (d) FAILURE TO PROVIDE EMERGENCY SERVICES.—This part may not be construed to authorize any emergency
p.001535: response em- ployee to fail to respond, or to deny services, to any victim of an emergency.
p.001535: (e) NOTIFICATION AND REPORTING DEADLINES.—In any case in which the Secretary determines that, wholly or
p.001535: partially as a result of a public health emergency that has been determined pursuant to section 319(a),
p.001535: individuals or public or private entities are un- able to comply with the requirements of this part,
p.001535: the Secretary may, notwithstanding any other provision of law, temporarily sus- pend, in whole or in part, the
p.001535: requirements of this part as the cir- cumstances reasonably require. Before or promptly after such a
p.001535: suspension, the Secretary shall notify the Congress of such action and publish in the Federal Register a
p.001535: notice of the suspension.
p.001535: (f) CONTINUED APPLICATION OF STATE AND LOCAL LAW.—Noth- ing in this part shall be construed to limit the
p.001535: application of State or local laws that require the provision of data to public health au- thorities.
p.001535: SEC. 2695H. ø300ff–139¿ INJUNCTIONS REGARDING VIOLATION OF PRO- HIBITION.
p.001535: (a) IN GENERAL.—The Secretary may, in any court of com- petent jurisdiction, commence a civil action for
p.001535: the purpose of ob-
p.001535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001535:
p.001537: 1537
p.001537: PUBLIC HEALTH SERVICE ACT
p.001537: Sec. 2701
p.001537:
p.001537: taining temporary or permanent injunctive relief with respect to any violation of this part.
p.001537: (b) FACILITATION OF INFORMATION ON VIOLATIONS.—The Sec- retary shall establish an administrative process
p.001537: for encouraging emergency response employees to provide information to the Sec- retary regarding violations
p.001537: of this part. As appropriate, the Sec- retary shall investigate alleged such violations and seek appro-
p.001537: priate injunctive relief.
p.001537: SEC. 2695I. ø300ff–140¿ APPLICABILITY OF PART.
p.001537: This part shall not apply in a State if the chief executive officer of the State certifies to the Secretary that
p.001537: the law of the State is substantially consistent with this part.
p.001537: TITLE XXVII—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
p.001537:
p.001537: PART A—INDIVIDUAL AND GROUP MARKET REFORMS
p.001537: Subpart I—General Reform
p.001537: SEC. 2701. ø300gg¿ FAIR HEALTH INSURANCE PREMIUMS.
p.001537: (a) 1 PROHIBITING DISCRIMINATORY PREMIUM RATES.—
p.001537: (1) IN GENERAL.—With respect to the premium rate charged by a health insurance issuer for health
p.001537: insurance cov- erage offered in the individual or small group market—
p.001537: (A) such rate shall vary with respect to the particular plan or coverage involved only by—
p.001537: (i) whether such plan or coverage covers an indi- vidual or family;
p.001537: (ii) rating area, as established in accordance with paragraph (2);
p.001537: (iii) age, except that such rate shall not vary by more than 3 to 1 for adults (consistent with
p.001537: section 2707(c)); and
p.001537: (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
p.001537: (B) such rate shall not vary with respect to the par- ticular plan or coverage involved by any other
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p.001569: para- graph (1); or
p.001569: (B) if the plan is a self-insured plan that is not subject to State insurance regulation (including a State law
p.001569: that
p.001569: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001569:
p.001571: 1571
p.001571: PUBLIC HEALTH SERVICE ACT
p.001571: Sec. 2719A
p.001571:
p.001571: establishes an external review process described in para- graph (1)).
p.001571: (c) SECRETARY AUTHORITY.—The Secretary may deem the ex- ternal review process of a group health plan or
p.001571: health insurance issuer, in operation as of the date of enactment of this section, to be in compliance
p.001571: with the applicable process established under sub- section (b), as determined appropriate by the Secretary.
p.001571: SEC. 2719A. ø300gg–19a¿ PATIENT PROTECTIONS.
p.001571: (a) CHOICE OF HEALTH CARE PROFESSIONAL.—If a group health plan, or a health insurance issuer offering group
p.001571: or individual health insurance coverage, requires or provides for designation by a participant, beneficiary,
p.001571: or enrollee of a participating primary care provider, then the plan or issuer shall permit each participant,
p.001571: beneficiary, and enrollee to designate any participating primary care provider who is available to accept such
p.001571: individual.
p.001571: (b) COVERAGE OF EMERGENCY SERVICES.—
p.001571: (1) IN GENERAL.—If a group health plan, or a health insur- ance issuer offering group or individual health
p.001571: insurance issuer, provides or covers any benefits with respect to services in an emergency department of a
p.001571: hospital, the plan or issuer shall cover emergency services (as defined in paragraph (2)(B))—
p.001571: (A) without the need for any prior authorization deter- mination;
p.001571: (B) whether the health care provider furnishing such services is a participating provider with respect to
p.001571: such services;
p.001571: (C) in a manner so that, if such services are provided to a participant, beneficiary, or enrollee—
p.001571: (i) by a nonparticipating health care provider with or without prior authorization; or
p.001571: (ii)(I) such services will be provided without im- posing any requirement under the plan for prior au-
p.001571: thorization of services or any limitation on coverage where the provider of services does not have a contrac-
p.001571: tual relationship with the plan for the providing of services that is more restrictive than the requirements or
p.001571: limitations that apply to emergency department services received from providers who do have such a
p.001571: contractual relationship with the plan; and
p.001571: (II) if such services are provided out-of-network, the cost-sharing requirement (expressed as a copay- ment
p.001571: amount or coinsurance rate) is the same require- ment that would apply if such services were provided
p.001571: in-network; 9
p.001571: (D) without regard to any other term or condition of such coverage (other than exclusion or coordination of
p.001571: ben- efits, or an affiliation or waiting period, permitted under section 2701 of this Act, section 701
p.001571: of the Employee Re- tirement Income Security Act of 1974, or section 9801 of the Internal Revenue Code
p.001571: of 1986, and other than appli- cable cost-sharing).
p.001571:
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p.001571: January 30, 2020
p.001571: 9 Probably should read ‘‘; and’’.
p.001571:
p.001571: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001571:
p.001571: Sec. 2719A PUBLIC HEALTH SERVICE ACT 1572
p.001571: (2) DEFINITIONS.—In this subsection:
p.001571: (A) EMERGENCY MEDICAL CONDITION.—The term ‘‘emergency medical condition’’ means a medical
p.001571: condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent
p.001571: layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of
p.001571: immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section
p.001571: 1867(e)(1)(A) of the Social Security Act.
p.001571: (B) EMERGENCY SERVICES.—The term ‘‘emergency services’’ means, with respect to an emergency medical
p.001571: condition—
p.001571: (i) a medical screening examination (as required under section 1867 of the Social Security Act) that is
p.001571: within the capability of the emergency department of a hospital, including ancillary services routinely avail-
p.001571: able to the emergency department to evaluate such emergency medical condition, and
p.001571: (ii) within the capabilities of the staff and facili- ties available at the hospital, such further medical ex-
p.001571: amination and treatment as are required under sec- tion 1867 of such Act to stabilize the patient.
p.001571: (C) STABILIZE.—The term ‘‘to stabilize’’, with respect to an emergency medical condition (as defined in subpara-
p.001571: graph (A)), has the meaning give in section 1867(e)(3) of the Social Security Act (42 U.S.C. 1395dd(e)(3)).
p.001571: (c) ACCESS TO PEDIATRIC CARE.—
p.001571: (1) PEDIATRIC CARE.—In the case of a person who has a child who is a participant, beneficiary, or
p.001571: enrollee under a group health plan, or health insurance coverage offered by a health insurance issuer in
p.001571: the group or individual market, if the plan or issuer requires or provides for the designation of a
p.001571: participating primary care provider for the child, the plan or issuer shall permit such person to designate
p.001571: a physician (allopathic or osteopathic) who specializes in pediatrics as the child’s primary care
p.001571: provider if such provider participates in the network of the plan or issuer.
p.001571: (2) CONSTRUCTION.—Nothing in paragraph (1) shall be con- strued to waive any exclusions of coverage under the
p.001571: terms and conditions of the plan or health insurance coverage with respect to coverage of pediatric care.
p.001571: (d) PATIENT ACCESS TO OBSTETRICAL AND GYNECOLOGICAL CARE.—
p.001571:
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p.001571: January 30, 2020
p.001571: (1) GENERAL RIGHTS.—
p.001571: (A) DIRECT ACCESS.—A group health plan, or health insurance issuer offering group or individual health insur-
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p.001621: Subtitle A—National All-Hazards Pre- paredness and Response Planning, Co- ordinating, and Reporting
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p.001621: January 30, 2020
p.001621: SEC. 2801. ø42 U.S.C. 300hh¿ PUBLIC HEALTH AND MEDICAL PRE- PAREDNESS AND RESPONSE FUNCTIONS.
p.001621: (a) IN GENERAL.—The Secretary of Health and Human Serv- ices shall lead all Federal public health and
p.001621: medical response to public health emergencies and incidents covered by the National Response Plan developed
p.001621: pursuant to section 502(6) of the Home- land Security Act of 2002, or any successor plan.
p.001621: (b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration with the Secretary of Veterans Affairs, the
p.001621: Secretary of Transpor- tation, the Secretary of Defense, the Secretary of Homeland Secu- rity, and the
p.001621: head of any other relevant Federal agency, shall es- tablish an interagency agreement, consistent with the
p.001621: National Re- sponse Plan or any successor plan, under which agreement the Sec- retary of Health and Human Services
p.001621: shall assume operational control of emergency public health and medical response assets, as necessary, in the
p.001621: event of a public health emergency, except that members of the armed forces under the authority of the
p.001621: Secretary of Defense shall remain under the command and control of the Sec- retary of Defense, as shall any associated
p.001621: assets of the Department of Defense.
p.001621: SEC. 2802. ø42 U.S.C. 300hh–1¿ NATIONAL HEALTH SECURITY STRAT- EGY.
p.001621: (a) IN GENERAL.—
p.001621: (1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC HEALTH EMERGENCIES.—Beginning in 2018 and
p.001621: every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a
p.001621: coordinated strategy (to be known as the National Health Security Strategy) and any revi- sions thereof, and an
p.001621: accompanying implementation plan for public health emergency preparedness and response. Such Na- tional Health
p.001621: Security Strategy shall describe potential emer- gency health security threats and identify the
p.001621: process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond
p.001621: to such threats and shall be consistent with the national preparedness goal (as described in section 504(a)(19)
p.001621: of the Homeland Security Act of 2002), the National Incident Management System (as defined in sec- tion
p.001621: 501(7) of such Act), and the National Response Plan devel- oped pursuant to section 504 of such Act, or any
p.001621: successor plan.
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001621:
p.001621: Sec. 2802 PUBLIC HEALTH SERVICE ACT 1622
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p.001621: (A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities
p.001621: through drills and exercises, including drills and exercises to en- sure medical surge capacity for events
p.001621: without notice; and
p.001621: (B) integrating public and private sector public health and medical donations and volunteers.
p.001621: (2) PUBLIC HEALTH.—Developing and sustaining Federal, State, local, and tribal essential public health security
p.001621: capabili- ties, including the following:
p.001621: (A) Disease situational awareness domestically and abroad, including detection, identification, investigation,
p.001621: and related information technology activities.
p.001621: (B) Disease containment including capabilities for iso- lation, quarantine, social distancing,
p.001621: decontamination, rel- evant health care services and supplies, and transpor- tation and disposal of medical
p.001621: waste.
p.001621: (C) Risk communication and public preparedness.
p.001621: (D) Rapid distribution and administration of medical countermeasures.
p.001621: (E) Response to environmental hazards.
p.001621: (3) MEDICAL.—Increasing the preparedness, response capa- bilities, and surge capacity of hospitals, other health care
p.001621: facili- ties (including pharmacies, mental health facilities, and ambu- latory care facilities and which may
p.001621: include dental health fa- cilities), and trauma care, critical care, and emergency medical service systems, with
p.001621: respect to public health emergencies (in- cluding related availability, accessibility, and coordination),
p.001621: which shall include developing plans for the following:
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001623: PUBLIC HEALTH SERVICE ACT
p.001623: Sec. 2802
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p.001623: (A) Strengthening public health emergency medical and trauma management and treatment capabilities.
p.001623: (B) Fatality management.
p.001623: (C) Coordinated medical triage and evacuation to ap- propriate medical institutions based on patient
p.001623: medical need, taking into account regionalized systems of care.
p.001623: (D) Rapid distribution and administration of medical countermeasures.
p.001623: (E) Effective utilization of any available public and private mobile medical assets (which may include
p.001623: such dental health assets) and integration of other Federal as- sets.
p.001623: (F) Protecting health care workers and health care first responders from workplace exposures during a public
p.001623: health emergency or exposures to agents that could cause a public health emergency.
p.001623: (G) Optimizing a coordinated and flexible approach to the emergency response and medical surge capacity of hos-
p.001623: pitals, other health care facilities, critical care, trauma care (which may include trauma centers), and
p.001623: emergency medical systems.
p.001623: (4) AT-RISK INDIVIDUALS.—
p.001623: (A) Taking into account the public health and medical needs of at-risk individuals, including the unique needs
p.001623: and considerations of individuals with disabilities, in the event of a public health emergency.
p.001623: (B) For the purpose of this Act, the term ‘‘at-risk indi- viduals’’ means children, pregnant women, senior
p.001623: citizens and other individuals who have access or functional needs in the event of a public health emergency,
p.001623: as determined by the Secretary.
p.001623: (5) COORDINATION.—Minimizing duplication of, and ensur- ing coordination between, Federal, State, local, and
p.001623: tribal plan- ning, preparedness, and response activities (including the State Emergency Management Assistance
p.001623: Compact and other appli- cable compacts). Such planning shall be consistent with the National Response
p.001623: Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.
p.001623: (6) CONTINUITY OF OPERATIONS.—Maintaining vital public health and medical services to allow for optimal Federal,
p.001623: State, local, and tribal operations in the event of a public health emergency.
p.001623: (7) COUNTERMEASURES.—
p.001623: (A) Promoting strategic initiatives to advance counter- measures to diagnose, mitigate, prevent, or treat harm
p.001623: from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally
p.001623: occurring, unintentional, or deliberate.
p.001623: (B) For purposes of this paragraph, the term ‘‘counter- measures’’ has the same meaning as the terms
p.001623: ‘‘qualified countermeasures’’ under section 319F–1, ‘‘qualified pan- demic and epidemic products’’ under
p.001623: section 319F–3, and ‘‘security countermeasures’’ under section 319F–2.
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001623: Sec. 2803 PUBLIC HEALTH SERVICE ACT 1624
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p.001623: January 30, 2020
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p.001623: (8) MEDICAL AND PUBLIC HEALTH COMMUNITY RESIL- IENCY.—Strengthening the ability of States, local
p.001623: communities, and tribal communities to prepare for, respond to, and be resil- ient in the event of public health
p.001623: emergencies, whether natu- rally occurring, unintentional, or deliberate by—
p.001623: (A) optimizing alignment and integration of medical and public health preparedness and response planning and
p.001623: capabilities with and into routine daily activities; and
p.001623: (B) promoting familiarity with local medical and public health systems.
p.001623: (9) ZOONOTIC DISEASE, FOOD, AND AGRICULTURE.—Improv- ing coordination among Federal, State, local, Tribal, and
p.001623: terri- torial entities (including through consultation with the Sec- retary of Agriculture) to prevent,
p.001623: detect, and respond to out- breaks of plant or animal disease (including zoonotic disease) that could
p.001623: compromise national security resulting from a delib- erate attack, a naturally occurring threat, the intentional adul-
p.001623: teration of food, or other public health threats, taking into ac- count interactions between animal health, human
p.001623: health, and animals’ and humans’ shared environment as directly related to public health emergency
p.001623: preparedness and response capa- bilities, as applicable.
p.001623: (10) GLOBAL HEALTH SECURITY.—Assessing current or po- tential health security threats from abroad to inform
p.001623: domestic public health preparedness and response capabilities.
p.001623: SEC. 2803. ø42 U.S.C. 300hh–2¿ ENHANCING MEDICAL SURGE CAPACITY.
p.001623: (a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part of the joint review described in section 2812(b), the
p.001623: Secretary shall evaluate the benefits and feasibility of improving the capacity of the Department of Health
p.001623: and Human Services to provide addi- tional medical surge capacity to local communities in the event of
p.001623: a public health emergency. Such study shall include an assessment of the need for and feasibility of
p.001623: improving surge capacity through—
p.001623: (1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis,
p.001623: to a com- munity in the event of a public health emergency;
p.001623: (2) integrating the practice of telemedicine within the Na- tional Disaster Medical System; and
p.001623: (3) other strategies to improve such capacity as determined appropriate by the Secretary.
p.001623: (b) AUTHORITY TO ACQUIRE AND OPERATE MOBILE MEDICAL AS- SETS.—In addition to any other authority to
p.001623: acquire, deploy, and operate mobile medical assets, the Secretary may acquire, deploy, and operate mobile
p.001623: medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deploy-
p.001623: ment, and operation is determined to be beneficial and feasible in improving the capacity of the
p.001623: Department of Health and Human Services to provide additional medical surge capacity to local com-
p.001623: munities in the event of a public health emergency.
p.001623: (c) USING FEDERAL FACILITIES TO ENHANCE MEDICAL SURGE CAPACITY.—
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001625: PUBLIC HEALTH SERVICE ACT
p.001625: Sec. 2811
p.001625:
p.001625: (1) ANALYSIS.—The Secretary shall conduct an analysis of whether there are Federal facilities which, in
p.001625: the event of a public health emergency, could practicably be used as facilities in which to provide health care.
p.001625: (2) MEMORANDA OF UNDERSTANDING.—If, based on the analysis conducted under paragraph (1), the
p.001625: Secretary deter- mines that there are Federal facilities which, in the event of a public health emergency,
p.001625: could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility,
p.001625: seek to conclude a memorandum of under- standing with the head of the Department or agency that oper-
p.001625: ates such facility that permits the use of such facility to pro- vide health care in the event of a public
p.001625: health emergency.
p.001625:
p.001625: Subtitle B—All-Hazards Emergency Preparedness and Response
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p.001625: January 30, 2020
p.001625: SEC. 2811. ø42 U.S.C. 300hh–10¿ COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS PUBLIC HEALTH
p.001625: EMERGENCIES.
p.001625: (a) IN GENERAL.—There is established within the Department of Health and Human Services the position of
p.001625: the Assistant Sec- retary for Preparedness and Response. The President, with the ad- vice and consent of the Senate,
p.001625: shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Sec-
p.001625: retary.
p.001625: (b) DUTIES.—Subject to the authority of the Secretary, the As- sistant Secretary for Preparedness and Response shall
p.001625: utilize expe- rience related to public health emergency preparedness and re- sponse, biodefense, medical
p.001625: countermeasures, and other relevant topics to carry out the following functions:
p.001625: (1) LEADERSHIP.—Serve as the principal advisor to the Sec- retary on all matters related to Federal public health and
p.001625: med- ical preparedness and response for public health emergencies.
p.001625: (2) PERSONNEL.—Register, credential, organize, train, equip, and have the authority to deploy
p.001625: Federal public health and medical personnel under the authority of the Secretary, in- cluding the National
p.001625: Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emer- gency System
p.001625: for Advance Registration of Volunteer Health Professionals.
p.001625: (3) COUNTERMEASURES.—Oversee advanced research, de- velopment, and procurement of qualified countermeasures
p.001625: (as defined in section 319F–1), security countermeasures (as de- fined in section 319F–2), and qualified
p.001625: pandemic or epidemic products (as defined in section 319F–3).
p.001625: (4) COORDINATION.—
p.001625: (A) FEDERAL INTEGRATION.—Coordinate with relevant Federal officials to ensure integration of Federal prepared- ness
p.001625: and response activities for public health emergencies.
p.001625: (B) STATE, LOCAL, AND TRIBAL INTEGRATION.—Coordi- nate with State, local, and tribal public health officials, the
p.001625: Emergency Management Assistance Compact, health care
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001625:
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p.001625: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1626
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p.001625: January 30, 2020
p.001625:
p.001625: systems, and emergency medical service systems to ensure effective integration of Federal public health and
p.001625: medical assets during a public health emergency.
p.001625: (C) EMERGENCY MEDICAL SERVICES.—Promote im- proved emergency medical services medical direction, sys-
p.001625: tem integration, research, and uniformity of data collec- tion, treatment protocols, and policies with
p.001625: regard to pub- lic health emergencies.
p.001625: (D) POLICY COORDINATION AND STRATEGIC DIREC- TION.—Provide integrated policy coordination and strategic
p.001625: direction, before, during, and following public health emer- gencies, with respect to all matters related to Federal
p.001625: pub- lic health and medical preparedness and execution and de- ployment of the Federal response for public
p.001625: health emer- gencies and incidents covered by the National Response Plan described in section 504(a)(6) of
p.001625: the Homeland Secu- rity Act of 2002 (6 U.S.C. 314(a)(6)), or any successor plan; and such Federal responses
p.001625: covered by the National Cybersecurity Incident Response Plan developed under section 228(c) of the
p.001625: Homeland Security Act of 2002 (6
p.001625: U.S.C. 149(c)), including public health emergencies or inci- dents related to cybersecurity threats that present a
p.001625: threat to national health security.
p.001625: (E) IDENTIFICATION OF INEFFICIENCIES.—Identify and minimize gaps, duplication, and other inefficiencies
p.001625: in medical and public health preparedness and response ac- tivities and the actions necessary to overcome
p.001625: these obsta- cles.
p.001625: (F) COORDINATION OF GRANTS AND AGREEMENTS.— Align and coordinate medical and public health grants and
p.001625: cooperative agreements as applicable to preparedness and response activities authorized under this Act, to the
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p.001627: (ii) unknown threats for which no counter- measures are available.
p.001627: (H) NATIONAL SECURITY PRIORITY.—On a periodic basis consult with, as applicable and appropriate, the Assistant
p.001627: to the President for National Security Affairs, to provide an update on, and discuss, medical and public health
p.001627: pre- paredness and response activities pursuant to this Act and the Federal Food, Drug, and Cosmetic Act,
p.001627: including progress on the development, approval, clearance, and li- censure of medical countermeasures.
p.001627: (I) THREAT AWARENESS.—Coordinate with the Director of the Centers for Disease Control and Prevention, the Di-
p.001627: rector of National Intelligence, the Secretary of Homeland Security, the Assistant to the President for National Secu-
p.001627: rity Affairs, the Secretary of Defense, and other relevant Federal officials, such as the Secretary of
p.001627: Agriculture, to maintain a current assessment of national security threats and inform preparedness and response
p.001627: capabilities based on the range of the threats that have the potential to re- sult in a public health
p.001627: emergency.
p.001627: (5) LOGISTICS.—In coordination with the Secretary of Vet- erans Affairs, the Secretary of Homeland Security, the
p.001627: General Services Administration, and other public and private entities, provide logistical support for medical and
p.001627: public health aspects of Federal responses to public health emergencies. Such logistical support shall
p.001627: include working with other relevant Federal, State, local, Tribal, and territorial public health offi-
p.001627: cials and private sector entities to identify the critical infra- structure assets, systems, and networks
p.001627: needed for the proper functioning of the health care and public health sectors that need to be maintained
p.001627: through any emergency or disaster, in- cluding entities capable of assisting with, responding to, and
p.001627: mitigating the effect of a public health emergency, including a public health emergency determined by the Secretary
p.001627: pursuant to section 319(a) or an emergency or major disaster declared by the President under the Robert T. Stafford
p.001627: Disaster Relief and Emergency Assistance Act or the National Emergencies Act, including by establishing methods
p.001627: to exchange critical informa- tion and deliver products consumed or used to preserve, pro- tect, or sustain
p.001627: life, health, or safety, and sharing of specialized expertise.
p.001627: (6) LEADERSHIP.—Provide leadership in international pro- grams, initiatives, and policies that deal with public
p.001627: health and medical emergency preparedness and response.
p.001627: (7) COUNTERMEASURES BUDGET PLAN.—Develop, and up- date not later than March 15 of each year, a coordinated
p.001627: 5-year budget plan based on the medical countermeasure priorities described in subsection (d), including with
p.001627: respect to chemical, biological, radiological, and nuclear agent or agents that may present a threat to the
p.001627: Nation, including such agents that are novel or emerging infectious diseases, and the corresponding efforts to
p.001627: develop qualified countermeasures (as defined in sec- tion 319F–1), security countermeasures (as defined in
p.001627: section 319F–2), and qualified pandemic or epidemic products (as de-
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001627: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1628
p.001627: fined in section 319F–3) for each such threat. Each such plan shall—
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p.001627: (A) include consideration of the entire medical coun- termeasures enterprise, including—
p.001627: (i) basic research and advanced research and de- velopment;
p.001627: (ii) approval, clearance, licensure, and authorized uses of products;
p.001627: (iii) procurement, stockpiling, maintenance, and potential replenishment (including manufacturing ca-
p.001627: pabilities) of all products in the Strategic National Stockpile;
p.001627: (iv) the availability of technologies that may assist in the advanced research and development of counter- measures
p.001627: and opportunities to use such technologies to accelerate and navigate challenges unique to coun- termeasure
p.001627: research and development; and
p.001627: (v) potential deployment, distribution, and utiliza- tion of medical countermeasures; development of clin- ical
p.001627: guidance and emergency use instructions for the use of medical countermeasures; and, as applicable,
p.001627: potential postdeployment activities related to medical countermeasures;
p.001627: (B) inform prioritization of resources and include measurable outputs and outcomes to allow for the
p.001627: tracking of the progress made toward identified priorities;
p.001627: (C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs
p.001627: within the continuum of the medical countermeasure enterprise consistent with section 319F–2;
p.001627: (D) identify the full range of anticipated medical coun- termeasure needs related to research and development,
p.001627: procurement, and stockpiling, including the potential need for indications, dosing, and administration
p.001627: technologies, and other countermeasure needs as applicable and appro- priate;
p.001627: (E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Com-
p.001627: mittee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations
p.001627: and the Committee on Energy and Commerce of the House of Rep- resentatives; and
p.001627: (F) not later than March 15 of each year, be made publicly available in a manner that does not
p.001627: compromise national security.
p.001627: (c) FUNCTIONS.—The Assistant Secretary for Preparedness and Response shall—
p.001627: (1) have lead responsibility within the Department of Health and Human Services for emergency
p.001627: preparedness and response policy coordination and strategic direction;
p.001627: (2) have authority over and responsibility for—
p.001627: (A) the National Disaster Medical System pursuant to section 2812;
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001629: 1629
p.001629: PUBLIC HEALTH SERVICE ACT
p.001629: Sec. 2811
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p.001629: (B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2;
p.001629: (C) the Biomedical Advanced Research and Develop- ment Authority pursuant to section 319L;
p.001629: (D) the Medical Reserve Corps pursuant to section 2813;
p.001629: (E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and
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p.001629: (F) administering grants and related authorities re- lated to trauma care under parts A through C of title XII,
p.001629: such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services
p.001629: Ad- ministration to such Assistant Secretary;
p.001629: (3) exercise the responsibilities and authorities of the Sec- retary with respect to the coordination of—
p.001629: (A) the Public Health Emergency Preparedness Coop- erative Agreement Program pursuant to section 319C–1;
p.001629: (B) the Strategic National Stockpile pursuant to sec- tion 319F–2; and
p.001629: (C) the Cities Readiness Initiative; and
p.001629: (4) assume other duties as determined appropriate by the Secretary.
p.001629: (d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
p.001629: (1) IN GENERAL.—Not later than March 15, 2020, and bien- nially thereafter, the Assistant Secretary for Preparedness
p.001629: and Response shall develop and submit to the appropriate commit- tees of Congress a coordinated strategy and
p.001629: accompanying im- plementation plan for medical countermeasures to address chemical, biological,
p.001629: radiological, and nuclear threats. In devel- oping such a plan, the Assistant Secretary for Preparedness and
p.001629: Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section
p.001629: 2811–1. Such strategy and plan shall be known as the ‘‘Public Health Emergency Medical Countermeasures Enterprise
p.001629: Strat- egy and Implementation Plan’’.
p.001629: (2) REQUIREMENTS.—The plan under paragraph (1) shall—
p.001629: (A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a
p.001629: threat to the Nation and the corresponding efforts to develop qualified countermeasures (as defined in
p.001629: section 319F–1), security countermeasures (as defined in section 319F–2), or quali- fied pandemic or
p.001629: epidemic products (as defined in section 319F–3) for each threat;
p.001629: (B) evaluate the progress of all activities with respect to such countermeasures or products, including
p.001629: research, advanced research, development, procurement, stockpiling, deployment, distribution, and utilization;
p.001629: (C) identify and prioritize near-, mid-, and long-term needs with respect to such countermeasures or
p.001629: products, and ancillary medical supplies to assist with the utiliza- tion of such countermeasures or
p.001629: products, to address a
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001629: 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F– 2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv),
p.001629: and 319F–2(c)(7)(C)(v) of
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p.001631: this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act,
p.001631: by sum- marizing—
p.001631: (i) the particular actions that were taken under the authorities specified, including, as applicable, the
p.001631: identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the
p.001631: authority was used;
p.001631: (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options
p.001631: that were considered and rejected with respect to the use of such authorities;
p.001631: (iii) the number of, nature of, and other informa- tion concerning the persons and entities that
p.001631: received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and
p.001631: en- tities that were considered and rejected for such a grant, cooperative agreement, or contract, except
p.001631: that the report need not disclose the identity of any such person or entity;
p.001631: (iv) whether, with respect to each procurement that is approved by the President under section 319F– 2(c)(6), a
p.001631: contract was entered into within one year after such approval by the President; and
p.001631: (v) with respect to section 319F–1(d), for the 2- year period for which the report is submitted, the
p.001631: number of persons who were paid amounts totaling
p.001631: $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less
p.001631: than $100,000; and
p.001631: (K) be made publicly available.
p.001631: (3) GAO REPORT.—
p.001631: (A) IN GENERAL.—Not later than 1 year after the date of the submission to the Congress of the first
p.001631: Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller
p.001631: Gen- eral of the United States shall conduct an independent evaluation, and submit to the appropriate
p.001631: committees of Congress a report, concerning such Strategy and Imple- mentation Plan.
p.001631: (B) CONTENT.—The report described in subparagraph
p.001631: (A) shall review and assess—
p.001631: (i) the near-term, mid-term, and long-term med- ical countermeasure needs and identified priorities of the
p.001631: Federal Government pursuant to paragraph (2)(C);
p.001631: (ii) the activities of the Department of Health and Human Services with respect to advanced research and
p.001631: development pursuant to section 319L; and
p.001631: (iii) the progress made toward meeting the timelines, allocations, benchmarks, and milestones
p.001631: identified in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implemen- tation
p.001631: Plan under this subsection.
p.001631: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001631: Sec. 2811–1 PUBLIC HEALTH SERVICE ACT 1632
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p.001631: January 30, 2020
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p.001631: (e) PROTECTION OF NATIONAL SECURITY.—In carrying out sub- sections (b)(7) and (d), the Secretary shall ensure
p.001631: that information and items that could compromise national security, contain con- fidential commercial
p.001631: information, or contain proprietary informa- tion are not disclosed.
p.001631: (f) PROTECTION OF NATIONAL SECURITY FROM THREATS.—
p.001631: (1) IN GENERAL.—In carrying out subsection (b)(3), the As- sistant Secretary for Preparedness and Response shall
p.001631: imple- ment strategic initiatives or activities to address threats, in- cluding pandemic influenza and which
p.001631: may include a chemical, biological, radiological, or nuclear agent (including any such agent with a significant
p.001631: potential to become a pandemic), that pose a significant level of risk to public health and national se- curity based
p.001631: on the characteristics of such threat. Such initia- tives shall include activities to—
p.001631: (A) accelerate and support the advanced research, de- velopment, manufacturing capacity, procurement,
p.001631: and stockpiling of countermeasures, including initiatives under section 319L(c)(4)(F);
p.001631: (B) support the development and manufacturing of virus seeds, clinical trial lots, and stockpiles of novel virus
p.001631: strains; and
p.001631: (C) maintain or improve preparedness activities, in- cluding for pandemic influenza.
p.001631: (2) AUTHORIZATION OF APPROPRIATIONS.—
p.001631: (A) IN GENERAL.—To carry out this subsection, there is authorized to be appropriated $250,000,000 for each of fis- cal
p.001631: years 2019 through 2023.
p.001631: (B) SUPPLEMENT, NOT SUPPLANT.—Amounts appro- priated under this paragraph shall be used to supplement and not
p.001631: supplant funds provided under sections 319L(d) and 319F–2(g).
p.001631: (C) DOCUMENTATION REQUIRED.—The Assistant Sec- retary for Preparedness and Response, in accordance with subsection
p.001631: (b)(7), shall document amounts expended for purposes of carrying out this subsection, including
p.001631: amounts appropriated under the heading ‘‘Public Health and Social Services Emergency Fund’’ under the
p.001631: heading ‘‘Office of the Secretary’’ under title II of division H of the Consolidated Appropriations Act, 2018
p.001631: (Public Law 115–
p.001631: 141) and allocated to carrying out section 319L(c)(4)(F).
p.001631: SEC. 2811–1. ø42 U.S.C. 300hh–10a¿ PUBLIC HEALTH EMERGENCY MED- ICAL COUNTERMEASURES ENTERPRISE.
p.001631: (a) IN GENERAL.—The Secretary shall establish the Public Health Emergency Medical Countermeasures
p.001631: Enterprise (referred to in this section as the ‘‘PHEMCE’’). The Assistant Secretary for Preparedness and
p.001631: Response shall serve as chair of the PHEMCE.
p.001631: (b) MEMBERS.—The PHEMCE shall include each of the fol- lowing members, or the designee of such members:
p.001631: (1) The Assistant Secretary for Preparedness and Re- sponse.
p.001631: (2) The Director of the Centers for Disease Control and Prevention.
p.001631: (3) The Director of the National Institutes of Health.
p.001631: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001633: PUBLIC HEALTH SERVICE ACT
p.001633: Sec. 2811A
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p.001633: (4) The Commissioner of Food and Drugs.
p.001633: (5) The Secretary of Defense.
p.001633: (6) The Secretary of Homeland Security.
p.001633: (7) The Secretary of Agriculture.
p.001633: (8) The Secretary of Veterans Affairs.
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p.001633: Sec. 2811A PUBLIC HEALTH SERVICE ACT 1634
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p.001633: January 30, 2020
p.001633:
p.001633: dren and Disasters’’ (referred to in this section as the ‘‘Advisory Committee’’).
p.001633: (b) DUTIES.—The Advisory Committee shall—
p.001633: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001633: applicable and appropriate;
p.001633: (2) evaluate and provide input with respect to the medical, mental and behavioral, and public health needs of
p.001633: children as they relate to preparation for, response to, and recovery from all-hazards emergencies; and
p.001633: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001633: and children, including related drills and exercises pursuant to the prepared- ness goals under section 2802(b).
p.001633: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001633: respect to chil- dren and the medical and public health grants and cooperative agreements as applicable
p.001633: to preparedness and response activities authorized under this title and title III.
p.001633: (d) MEMBERSHIP.—
p.001633: (1) IN GENERAL.—The Secretary, in consultation with such other Secretaries as may be appropriate, shall appoint
p.001633: not to exceed 25 members to the Advisory Committee. In appointing such members, the Secretary shall ensure
p.001633: that the total mem- bership of the Advisory Committee is an odd number.
p.001633: (2) REQUIRED NON-FEDERAL MEMBERS.—The Secretary, in consultation with such other heads of Federal agencies as
p.001633: may be appropriate, shall appoint to the Advisory Committee under paragraph (1) at least 13 individuals, including—
p.001633: (A) at least 2 non-Federal professionals with expertise in pediatric medical disaster planning, preparedness, re-
p.001633: sponse, or recovery;
p.001633: (B) at least 2 representatives from State, local, Tribal, or territorial agencies with expertise in pediatric
p.001633: disaster planning, preparedness, response, or recovery;
p.001633: (C) at least 4 members representing health care pro- fessionals, which may include members with expertise
p.001633: in pediatric emergency medicine; pediatric trauma, critical care, or surgery; the treatment of pediatric
p.001633: patients af- fected by chemical, biological, radiological, or nuclear agents, including emerging
p.001633: infectious diseases; pediatric mental or behavioral health related to children affected by a public health
p.001633: emergency; or pediatric primary care; and
p.001633: (D) other members as the Secretary determines appro- priate, of whom—
p.001633: (i) at least one such member shall represent a children’s hospital;
p.001633: (ii) at least one such member shall be an indi- vidual with expertise in schools or child care settings;
p.001633: (iii) at least one such member shall be an indi- vidual with expertise in children and youth with spe-
p.001633: cial health care needs; and
p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: 1635
p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
p.001635: more than 3 terms on the Advisory Committee, and not more than two of such terms may be served consecutively.
p.001635: (e) MEETINGS.—The Advisory Committee shall meet not less than biannually. At least one meeting per year shall be
p.001635: an in-per- son meeting.
p.001635: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001635: accordance with section 2811D.
p.001635: (g) SUNSET.—The Advisory Committee shall terminate on Sep- tember 30, 2023.
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p.001635: Sec. 2811B PUBLIC HEALTH SERVICE ACT 1636
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p.001635: January 30, 2020
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p.001635: fairs, shall establish an advisory committee to be known as the Na- tional Advisory Committee on Seniors and Disasters
p.001635: (referred to in this section as the ‘‘Advisory Committee’’).
p.001635: (b) DUTIES.—The Advisory Committee shall—
p.001635: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001635: applicable and appropriate;
p.001635: (2) evaluate and provide input with respect to the medical and public health needs of seniors related to
p.001635: preparation for, response to, and recovery from all-hazards emergencies; and
p.001635: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001635: relating to seniors, including related drills and exercises pursuant to the preparedness goals under section
p.001635: 2802(b).
p.001635: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001635: respect to sen- iors and the medical and public health grants and cooperative agreements as applicable to
p.001635: preparedness and response activities under this title and title III.
p.001635: (d) MEMBERSHIP.—
p.001635: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more
p.001635: than 17 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001635: total mem- bership of the Advisory Committee is an odd number.
p.001635: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001635: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Administrator of the Centers for Medicare & Medicaid Services.
p.001635: (G) The Administrator of the Administration for Com- munity Living.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Under Secretary for Health of the Department of Veterans Affairs.
p.001635: (J) At least 2 non-Federal health care professionals with expertise in geriatric medical disaster
p.001635: planning, pre- paredness, response, or recovery.
p.001635: (K) At least 2 representatives of State, local, Tribal, or territorial agencies with expertise in geriatric
p.001635: disaster planning, preparedness, response, or recovery.
p.001635: (L) Representatives of such other Federal agencies (such as the Department of Energy and the Department of
p.001635: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: Sec. 2811C
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p.001637: Homeland Security) as the Secretary determines necessary to fulfill the duties of the Advisory Committee.
p.001637: (e) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
p.001637: (2) EXTENSION OF COMMITTEE.—Not later than October 1, 2022, the Secretary shall submit to Congress a
p.001637: recommenda- tion on whether the Advisory Committee should be extended.
p.001637: SEC. 2811C. ø42 U.S.C. 300hh-10d¿ NATIONAL ADVISORY COMMITTEE ON INDIVIDUALS WITH DISABILITIES AND DISASTERS.
p.001637: (a) ESTABLISHMENT.—The Secretary, in consultation with the Secretary of Homeland Security, shall establish a
p.001637: national advisory committee to be known as the National Advisory Committee on In- dividuals with Disabilities and
p.001637: Disasters (referred to in this section as the ‘‘Advisory Committee’’).
p.001637: (b) DUTIES.—The Advisory Committee shall—
p.001637: (1) provide advice and consultation with respect to activi- ties carried out pursuant to section 2814, as
p.001637: applicable and ap- propriate;
p.001637: (2) evaluate and provide input with respect to the medical, public health, and accessibility needs of individuals
p.001637: with dis- abilities related to preparation for, response to, and recovery from all-hazards emergencies; and
p.001637: (3) provide advice and consultation with respect to State emergency preparedness and response activities,
p.001637: including re- lated drills and exercises pursuant to the preparedness goals under section 2802(b).
p.001637: (c) MEMBERSHIP.—
p.001637: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall
p.001637: appoint not more than 17 members to the Advisory Committee. In appointing such members, the Secretary shall
p.001637: ensure that the total membership of the Advisory Committee is an odd number.
p.001637: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001637: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001637: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001637: (B) The Administrator of the Administration for Com- munity Living.
p.001637: (C) The Director of the Biomedical Advanced Research and Development Authority.
p.001637: (D) The Director of the Centers for Disease Control and Prevention.
p.001637: (E) The Commissioner of Food and Drugs.
p.001637: (F) The Director of the National Institutes of Health.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: Sec. 2811D PUBLIC HEALTH SERVICE ACT 1638
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p.001637: (G) The Administrator of the Federal Emergency Man- agement Agency.
p.001637: (H) The Chair of the National Council on Disability.
p.001637: (I) The Chair of the United States Access Board.
p.001637: (J) The Under Secretary for Health of the Department of Veterans Affairs.
p.001637: (K) At least 2 non-Federal health care professionals with expertise in disability accessibility before, during,
p.001637: and after disasters, medical and mass care disaster planning, preparedness, response, or recovery.
p.001637: (L) At least 2 representatives from State, local, Tribal, or territorial agencies with expertise in disaster
p.001637: planning, preparedness, response, or recovery for individuals with disabilities.
p.001637: (M) At least 2 individuals with a disability with exper- tise in disaster planning, preparedness, response, or recov-
p.001637: ery for individuals with disabilities.
p.001637: (d) MEETINGS.—The Advisory Committee shall meet not less frequently than biannually. At least one meeting per
p.001637: year shall be an in-person meeting.
p.001637: (e) DISABILITY DEFINED.—For purposes of this section, the term ‘‘disability’’ has the meaning given such term in
p.001637: section 3 of the Americans with Disabilities Act of 1990.
p.001637: (f) COORDINATION.—The Secretary shall coordinate duties and activities authorized under this section in
p.001637: accordance with section 2811D.
p.001637: (g) SUNSET.—
p.001637: (1) IN GENERAL.—The Advisory Committee shall terminate on September 30, 2023.
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p.001639: regarding the steps taken to coordinate, as appropriate, the recommendations under this sec- tion, and provide a
p.001639: summary description of such coordination.
p.001639: SEC. 2812. ø42 U.S.C. 300hh–11¿ NATIONAL DISASTER MEDICAL SYSTEM.
p.001639: (a) NATIONAL DISASTER MEDICAL SYSTEM.—
p.001639: (1) IN GENERAL.—The Secretary shall provide for the oper- ation in accordance with this section of a system to
p.001639: be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary
p.001639: for Preparedness and Re- sponse as the head of the National Disaster Medical System, subject to the
p.001639: authority of the Secretary.
p.001639: (2) FEDERAL AND STATE COLLABORATIVE SYSTEM.—
p.001639: (A) IN GENERAL.—The National Disaster Medical Sys- tem shall be a coordinated effort by the Federal
p.001639: agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public or
p.001639: private en- tities, to carry out the purposes described in paragraph (3).
p.001639: (B) PARTICIPATING FEDERAL AGENCIES.—The Federal agencies referred to in subparagraph (A) are the Depart-
p.001639: ment of Health and Human Services, the Department of Homeland Security, the Department of Defense, and
p.001639: the Department of Veterans Affairs.
p.001639: (3) PURPOSE OF SYSTEM.—
p.001639: (A) IN GENERAL.—The Secretary may activate the Na- tional Disaster Medical System to—
p.001639: (i) provide health services, health-related social services, other appropriate human services, and appro- priate
p.001639: auxiliary services to respond to the needs of vic- tims of a public health emergency, including at-risk
p.001639: individuals as applicable (whether or not determined to be a public health emergency under section 319); or
p.001639: (ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that
p.001639: the Secretary has determined that a location is at risk of a public health emergency during the time specified, or
p.001639: there is a significant potential for a public health emergency.
p.001639: (B) ONGOING ACTIVITIES.—The National Disaster Med- ical System shall carry out such ongoing activities as may be
p.001639: necessary to prepare for the provision of services de- scribed in subparagraph (A) in the event that
p.001639: the Sec- retary activates the National Disaster Medical System for such purposes.
p.001639: (C) CONSIDERATIONS FOR AT-RISK POPULATIONS.—The Secretary shall take steps to ensure that an appropriate
p.001639: specialized and focused range of public health and medical capabilities are represented in the National Disaster Med-
p.001639: ical System, which take into account the needs of at-risk individuals, in the event of a public health
p.001639: emergency.
p.001639: (D) ADMINISTRATION.—The Secretary may determine and pay claims for reimbursement for services under sub-
p.001639: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001639: Sec. 2812 PUBLIC HEALTH SERVICE ACT 1640
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p.001639: paragraph (A) directly or through contracts that provide for payment in advance or by way of reimbursement.
p.001639: (E) TEST FOR MOBILIZATION OF SYSTEM.—During the one-year period beginning on the date of the enactment of the
p.001639: Pandemic and All-Hazards Preparedness Act, the Sec- retary shall conduct an exercise to test the capability
p.001639: and timeliness of the National Disaster Medical System to mo- bilize and otherwise respond effectively to a
p.001639: bioterrorist at- tack or other public health emergency that affects two or more geographic locations
p.001639: concurrently. Thereafter, the Secretary may periodically conduct such exercises regard- ing the National
p.001639: Disaster Medical System as the Secretary determines to be appropriate.
p.001639: (b) MODIFICATIONS.—
p.001639: (1) IN GENERAL.—Taking into account the findings from the joint review described under paragraph (2), the
p.001639: Secretary shall modify the policies of the National Disaster Medical Sys- tem as necessary.
p.001639: (2) JOINT REVIEW AND MEDICAL SURGE CAPACITY STRATEGIC PLAN.—
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p.001639: (A) REVIEW.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness and
p.001639: Advancing Innovation Act of 2019, the Secretary, in coordination with the Secretary of Homeland Security, the
p.001639: Secretary of Defense, and the Secretary of Veterans Af- fairs, shall conduct a joint review of the National
p.001639: Disaster Medical System. Such review shall include—
p.001639: (i) an evaluation of medical surge capacity, as de- scribed in section 2803(a);
p.001639: (ii) an assessment of the available workforce of the intermittent disaster response personnel described in
p.001639: subsection (c);
p.001639: (iii) the capacity of the workforce described in clause (ii) to respond to all hazards, including capacity to
p.001639: simultaneously respond to multiple public health emergencies and the capacity to respond to a nation- wide
p.001639: public health emergency;
p.001639: (iv) the effectiveness of efforts to recruit, retain, and train such workforce; and
p.001639: (v) gaps that may exist in such workforce and rec- ommendations for addressing such gaps.
p.001639: (B) UPDATES.—As part of the National Health Security Strategy under section 2802, the Secretary shall update the
p.001639: findings from the review under subparagraph (A) and provide recommendations to modify the policies of the Na-
p.001639: tional Disaster Medical System as necessary.
p.001639: (3) PARTICIPATION AGREEMENTS FOR NON-FEDERAL ENTI- TIES.—In carrying out paragraph (1), the Secretary shall
p.001639: estab- lish criteria regarding the participation of States and private entities in the National Disaster
p.001639: Medical System, including cri- teria regarding agreements for such participation. The criteria shall include the
p.001639: following:
p.001639: (A) Provisions relating to the custody and use of Fed- eral personal property by such entities, which
p.001639: may in the
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p.001641: 1641
p.001641: PUBLIC HEALTH SERVICE ACT
p.001641: Sec. 2812
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p.001641: January 30, 2020
p.001641: discretion of the Secretary include authorizing the custody and use of such property to respond to emergency
p.001641: situa- tions for which the National Disaster Medical System has not been activated by the Secretary pursuant to
p.001641: subsection (a)(3)(A). Any such custody and use of Federal personal property shall be on a reimbursable basis.
p.001641: (B) Provisions relating to circumstances in which an individual or entity has agreements with both the National
p.001641: Disaster Medical System and another entity regarding the provision of emergency services by the individual. Such
p.001641: provisions shall address the issue of priorities among the agreements involved.
p.001641: (c) INTERMITTENT DISASTER-RESPONSE PERSONNEL.—
p.001641: (1) IN GENERAL.—For the purpose of assisting the National Disaster Medical System in carrying out duties under this
p.001641: sec- tion, the Secretary may appoint individuals to serve as inter- mittent personnel of such System in
p.001641: accordance with applica- ble civil service laws and regulations.
p.001641: (2) LIABILITY.—For purposes of section 224(a) and the rem- edies described in such section, an individual appointed
p.001641: under paragraph (1) shall, while acting within the scope of such ap- pointment, be considered to be an
p.001641: employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to
p.001641: the participation of individuals ap- pointed under paragraph (1) in training programs authorized by the
p.001641: Assistant Secretary for Preparedness and Response or a comparable official of any Federal agency specified
p.001641: in sub- section (a)(2)(B), acts of individuals so appointed that are with- in the scope of such participation
p.001641: shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the
p.001641: individuals receive compensation for such par- ticipation).
p.001641: (3) NOTIFICATION.—Not later than 30 days after the date on which the Secretary determines the number of
p.001641: intermittent disaster-response personnel of the National Disaster Medical System is insufficient to address a
p.001641: public health emergency or potential public health emergency, the Secretary shall submit to the congressional
p.001641: committees of jurisdiction a notification detailing—
p.001641: (A) the impact such shortage could have on meeting public health needs and emergency medical
p.001641: personnel needs during a public health emergency; and
p.001641: (B) any identified measures to address such shortage.
p.001641: (4) CERTAIN APPOINTMENTS.—
p.001641: (A) IN GENERAL.—If the Secretary determines that the number of intermittent disaster response personnel within the
p.001641: National Disaster Medical System under this section is insufficient to address a public health emergency or poten- tial
p.001641: public health emergency, the Secretary may appoint candidates directly to personnel positions for
p.001641: intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant
p.001641: or unfilled posi- tions within such system to the congressional committees
p.001641: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001641:
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p.001641: Sec. 2812 PUBLIC HEALTH SERVICE ACT 1642
p.001641:
p.001641: of jurisdiction each quarter for which this authority is in effect.
p.001641: (B) SUNSET.—The authority under this paragraph shall expire on September 30, 2021.
p.001641: (5) 1 SERVICE BENEFIT.—Individuals appointed to serve under this subsection shall be considered
p.001641: eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The
p.001641: Secretary shall provide notification to any eligible individual of any effect such designation may have on other
p.001641: benefits for which such individual is eligible, includ- ing benefits from private entities.
p.001641: (d) CERTAIN EMPLOYMENT ISSUES REGARDING INTERMITTENT APPOINTMENTS.—
p.001641: (1) INTERMITTENT DISASTER-RESPONSE APPOINTEE.—For purposes of this subsection, the term ‘‘intermittent
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p.001643: ‘‘military neces- sity’’ for purposes of section 4312(b) of title 38, United States Code, pertaining to
p.001643: giving notice of absence from a position of employment. A determination of such necessity shall be made by the
p.001643: Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review.
p.001643: (4) LIMITATION.—An intermittent disaster-response ap- pointee shall not be deemed an employee of the Department
p.001643: of Health and Human Services for purposes other than those spe- cifically set forth in this section.
p.001643: (e) RULE OF CONSTRUCTION REGARDING USE OF COMMISSIONED CORPS.—If the Secretary assigns commissioned officers of
p.001643: the Reg- ular or Reserve Corps to serve with the National Disaster Medical System, such assignments do not affect
p.001643: the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps,
p.001643: respectively (including with respect to pay and al- lowances, retirement, benefits, rights, privileges, and
p.001643: immunities).
p.001643: (f) DEFINITION.—For purposes of this section, the term ‘‘auxil- iary services’’ includes mortuary services,
p.001643: veterinary services, and other services that are determined by the Secretary to be appro- priate with
p.001643: respect to the needs referred to in subsection (a)(3)(A).
p.001643: (g) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of providing for the Assistant Secretary for
p.001643: Preparedness and Re- sponse and the operations of the National Disaster Medical Sys- tem, other than
p.001643: purposes for which amounts in the Public Health Emergency Fund under section 319 are available, there are
p.001643: author- ized to be appropriated $57,400,000 for each of fiscal years 2019 through 2023.
p.001643: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001643: Sec. 2813 PUBLIC HEALTH SERVICE ACT 1644
p.001643:
p.001643: SEC. 2813. ø42 U.S.C. 300hh–15¿ VOLUNTEER MEDICAL RESERVE CORPS.
p.001643: (a) IN GENERAL.—Not later than 180 days after the date of en- actment of the Pandemic and All-Hazards
p.001643: Preparedness Act, the Secretary, in collaboration with State, local, and tribal officials, shall build on
p.001643: State, local, and tribal programs in existence on the date of enactment of such Act to establish and maintain a Medical
p.001643: Reserve Corps (referred to in this section as the ‘‘Corps’’) to provide for an adequate supply of volunteers in the
p.001643: case of a Federal, State, local, or tribal public health emergency. The Secretary may appoint a Director to head the
p.001643: Corps and oversee the activities of the Corps chapters that exist at the State, local, Tribal, and territorial levels.
p.001643: (b) STATE, LOCAL, AND TRIBAL COORDINATION.—The Corps shall be established using existing State,
p.001643: local, and tribal teams and shall not alter such teams.
p.001643: (c) COMPOSITION.—The Corps shall be composed of individuals who—
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p.001643: January 30, 2020
p.001643: (1)(A) are health professionals who have appropriate pro- fessional training and expertise as determined
p.001643: appropriate by the Director of the Corps; or
p.001643: (B) are non-health professionals who have an interest in serving in an auxiliary or support capacity to
p.001643: facilitate access to health care services in a public health emergency;
p.001643: (2) are certified in accordance with the certification pro- gram developed under subsection (d);
p.001643: (3) are geographically diverse in residence;
p.001643: (4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
p.001643: (5) indicate whether they are willing to be deployed out- side the area in which they reside in the
p.001643: event of a public health emergency.
p.001643: (d) CERTIFICATION; DRILLS.—
p.001643: (1) CERTIFICATION.—The Director, in collaboration with State, local, and tribal officials, shall establish a
p.001643: process for the periodic certification of individuals who volunteer for the Corps, as determined by the
p.001643: Secretary, which shall include the completion by each individual of the core training programs de- veloped under
p.001643: section 319F, as required by the Director. Such certification shall not supercede State
p.001643: licensing or credentialing requirements.
p.001643: (2) DRILLS.—In conjunction with the core training pro- grams referred to in paragraph (1), and in order
p.001643: to facilitate the integration of trained volunteers into the health care sys- tem at the local level, Corps
p.001643: members shall engage in periodic training exercises to be carried out at the local level. Such training
p.001643: exercises shall, as appropriate and applicable, incor- porate the needs of at-risk individuals in the event of a
p.001643: public health emergency.
p.001643: (e) DEPLOYMENT.—During a public health emergency, the Sec- retary shall have the authority to activate and
p.001643: deploy willing mem- bers of the Corps to areas of need, taking into consideration the public health and
p.001643: medical expertise required, with the concurrence of the State, local, or tribal officials from the area where the mem-
p.001643: bers reside.
p.001643: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645: 1645
p.001645: PUBLIC HEALTH SERVICE ACT
p.001645: Sec. 2814
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p.001645: (f) EXPENSES AND TRANSPORTATION.—While engaged in per- forming duties as a member of the Corps pursuant
p.001645: to an assign- ment by the Secretary (including periods of travel to facilitate such assignment), members of the
p.001645: Corps who are not otherwise em- ployed by the Federal Government shall be allowed travel or trans- portation
p.001645: expenses, including per diem in lieu of subsistence.
p.001645: (g) IDENTIFICATION.—The Secretary, in cooperation and con- sultation with the States, shall develop a
p.001645: Medical Reserve Corps Identification Card that describes the licensure and certification in- formation of Corps
p.001645: members, as well as other identifying informa- tion determined necessary by the Secretary.
p.001645: (h) INTERMITTENT DISASTER-RESPONSE PERSONNEL.—
p.001645: (1) IN GENERAL.—For the purpose of assisting the Corps in carrying out duties under this section, during a
p.001645: public health emergency, the Secretary may appoint selected individuals to serve as intermittent personnel
p.001645: of such Corps in accordance with applicable civil service laws and regulations. In all other cases,
p.001645: members of the Corps are subject to the laws of the State in which the activities of the Corps are
p.001645: undertaken.
p.001645: (2) APPLICABLE PROTECTIONS.—Subsections (c)(2), (d), and
p.001645: (e) of section 2812 shall apply to an individual appointed under paragraph (1) in the same manner as such
p.001645: subsections apply to an individual appointed under section 2812(c).
p.001645: (3) LIMITATION.—State, local, and tribal officials shall have no authority to designate a member of the Corps
p.001645: as Federal intermittent disaster-response personnel, but may request the services of such members.
p.001645: (i) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001645: $11,200,000 for each of fiscal years 2019 through 2023.
p.001645: SEC. 2814. ø42 U.S.C. 300hh–16¿ AT-RISK INDIVIDUALS.
p.001645: The Secretary, acting through such employee of the Depart- ment of Health and Human Services as
p.001645: determined by the Sec- retary and designated publicly (which may, at the discretion of the Secretary, involve the
p.001645: appointment or designation of an individual as the Director of At-Risk Individuals), shall—
p.001645: (1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response
p.001645: for at- risk individuals in the event of a public health emergency de- clared by the Secretary under section
p.001645: 319;
p.001645: (2) oversee the implementation of the preparedness goals described in section 2802(b) with respect to the
p.001645: public health and medical needs of at-risk individuals in the event of a pub- lic health emergency, as described in
p.001645: section 2802(b)(4);
p.001645: (3) assist other Federal agencies responsible for planning for, responding to, and recovering from public
p.001645: health emer- gencies in addressing the needs of at-risk individuals;
p.001645: (4) provide guidance to and ensure that recipients of State and local public health grants include preparedness
p.001645: and re- sponse strategies and capabilities that take into account the medical and public health needs of
p.001645: at-risk individuals in the event of a public health emergency, as described in section
p.001645: 319C–1(b)(2)(A)(iii);
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645: (5) ensure that the contents of the strategic national stock- pile take into account at-risk populations as
p.001645: described in sec- tion 2802(b)(4)(B);
p.001645: (6) oversee curriculum development for the public health and medical response training program on medical
p.001645: manage- ment of casualties, as it concerns at-risk individuals as de- scribed in subparagraphs (A) through (C)
p.001645: of section 319F(a)(2);
p.001645: (7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk
p.001645: individuals before, during, and following public health emergencies in as timely a manner as is practicable,
p.001645: including from the time a public health threat is identified;
p.001645: (8) ensure that public health and medical information dis- tributed by the Department of Health and Human
p.001645: Services during a public health emergency is delivered in a manner that takes into account the range of communication
p.001645: needs of the in- tended recipients, including at-risk individuals; and
p.001645: (9) facilitate coordination to ensure that, in implementing the situational awareness and biosurveillance
p.001645: network under section 319D, the Secretary considers incorporating data and information from Federal, State,
p.001645: local, Tribal, and territorial public health officials and entities relevant to detecting emerg- ing public health
p.001645: threats that may affect at-risk individuals, such as pregnant and postpartum women and infants, includ-
p.001645: ing adverse health outcomes of such populations related to such emerging public health threats.
p.001645: SEC. 2815. ø42 U.S.C. 300hh–17¿ EMERGENCY RESPONSE COORDINATION OF PRIMARY CARE PROVIDERS.
p.001645: The Secretary, acting through Administrator 2 of the Health Resources and Services Administration, and in
p.001645: coordination with the Assistant Secretary for Preparedness and Response, shall
p.001645: (1) provide guidance and technical assistance to health centers funded under section 330 and to State and local
p.001645: health departments and emergency managers to integrate health cen- ters into State and local emergency response plans
p.001645: and to bet- ter meet the primary care needs of populations served by health centers during public health
p.001645: emergencies; and
p.001645: (2) encourage employees at health centers funded under section 330 to participate in emergency medical
p.001645: response pro- grams including the National Disaster Medical System author- ized in section 2812, the Volunteer Medical
p.001645: Reserve Corps au- thorized in section 2813, and the Emergency System for Ad- vance Registration of Health
p.001645: Professions Volunteers authorized in section 319I.
p.001645:
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p.001645: January 30, 2020
p.001645: 2 So in law. Probably should read ‘‘the Administrator’’.
p.001645: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001647: 1647
p.001647: PUBLIC HEALTH SERVICE ACT
p.001647: Sec. 2822
p.001647:
p.001647: Subtitle C—Strengthening Public Health Surveillance Systems
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p.001647:
p.001647: January 30, 2020
p.001647: SEC. 2821. ø42 U.S.C. 300hh–31¿ EPIDEMIOLOGY-LABORATORY CAPAC- ITY GRANTS.
p.001647: (a) IN GENERAL.—Subject to the availability of appropriations, the Secretary, acting through the Director
p.001647: of the Centers for Dis- ease Control and Prevention, shall establish an Epidemiology and Laboratory
...

p.001649:
p.001649:
p.001649:
p.001649:
p.001649:
p.001649:
p.001649:
p.001649:
p.001649: January 30, 2020
p.001649: (D) demonstrates—
p.001649: (i) an ability to work with other State and commu- nity-based agencies;
p.001649: (ii) an understanding of respite care and family caregiver issues across all age groups, disabilities, and
p.001649: chronic conditions; and
p.001649: (iii) the capacity to ensure meaningful involve- ment of family members, family caregivers, and care
p.001649: recipients.
p.001649: (5) FAMILY CAREGIVER.—The term ‘‘family caregiver’’ means an unpaid family member, a foster parent,
p.001649: or another unpaid adult, who provides in-home monitoring, management, supervision, or treatment of a child
p.001649: or adult with a special need.
p.001649: (6) LIFESPAN RESPITE CARE.—The term ‘‘lifespan respite care’’ means a coordinated system of accessible,
p.001649: community- based respite care services for family caregivers of children or adults with special needs.
p.001649: (7) RESPITE CARE.—The term ‘‘respite care’’ means planned or emergency care provided to a child or adult with
p.001649: a special need in order to provide temporary relief to the family care- giver of that child or adult.
p.001649: (8) STATE.—The term ‘‘State’’ means any of the several States, the District of Columbia, the Virgin
p.001649: Islands of the United States, the Commonwealth of Puerto Rico, Guam, American Samoa, and the
p.001649: Commonwealth of the Northern Mariana Islands.
p.001649: SEC. 2902. ø300ii–1¿ LIFESPAN RESPITE CARE GRANTS AND COOPERA- TIVE AGREEMENTS.
p.001649: (a) PURPOSES.—The purposes of this section are—
p.001649: (1) to expand and enhance respite care services to family caregivers;
p.001649: (2) to improve the statewide dissemination and coordina- tion of respite care; and
p.001649: (3) to provide, supplement, or improve access and quality of respite care services to family caregivers,
p.001649: thereby reducing family caregiver strain.
p.001649: (b) AUTHORIZATION.—Subject to subsection (e), the Secretary is authorized to award grants or cooperative agreements for
p.001649: the pur- poses described in subsection (a) to eligible State agencies for which an application is submitted
p.001649: pursuant to subsection (d).
p.001649: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001649:
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p.001653: January 30, 2020
p.001653: SEC. 3000. ø300jj¿ DEFINITIONS.
p.001653: In this title:
p.001653: (1) CERTIFIED EHR TECHNOLOGY.—The term ‘‘certified EHR technology’’ means a qualified electronic health record
p.001653: that is certified pursuant to section 3001(c)(5) as meeting standards adopted under section 3004 that are
p.001653: applicable to the type of record involved (as determined by the Secretary, such as an ambulatory
p.001653: electronic health record for office-based physicians or an inpatient hospital electronic health record for
p.001653: hospitals).
p.001653: (2) ENTERPRISE INTEGRATION.—The term ‘‘enterprise inte- gration’’ means the electronic linkage of health care
p.001653: providers, health plans, the government, and other interested parties, to enable the electronic exchange
p.001653: and use of health information among all the components in the health care infrastructure in accordance with
p.001653: applicable law, and such term includes related application protocols and other related standards.
p.001653: (3) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ includes a hospital, skilled nursing
p.001653: facility, nursing fa- cility, home health entity or other long term care facility, health care clinic,
p.001653: community mental health center (as defined in section 1913(b)(1)), renal dialysis facility, blood center, am-
p.001653: bulatory surgical center described in section 1833(i) of the So- cial Security Act, emergency medical
p.001653: services provider, Feder- ally qualified health center, group practice, a pharmacist, a pharmacy, a
p.001653: laboratory, a physician (as defined in section
p.001653: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001653:
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p.001653:
p.001653: Sec. 3000 PUBLIC HEALTH SERVICE ACT 1654
p.001653:
p.001653: 1861(r) of the Social Security Act), a practitioner (as described in section 1842(b)(18)(C) of the Social Security
p.001653: Act), a provider operated by, or under contract with, the Indian Health Service or by an Indian tribe (as defined in
p.001653: the Indian Self-Determina- tion and Education Assistance Act), tribal organization, or urban Indian
p.001653: organization (as defined in section 4 of the In- dian Health Care Improvement Act), a rural health
p.001653: clinic, a covered entity under section 340B, an ambulatory surgical cen- ter described in section 1833(i) of the
p.001653: Social Security Act, a therapist (as defined in section 1848(k)(3)(B)(iii) of the Social Security Act),
p.001653: and any other category of health care facility, entity, practitioner, or clinician determined appropriate by the
p.001653: Secretary.
p.001653: (4) HEALTH INFORMATION.—The term ‘‘health information’’ has the meaning given such term in section 1171(4) of
p.001653: the So- cial Security Act.
p.001653: (5) HEALTH INFORMATION TECHNOLOGY.—The term ‘‘health information technology’’ means hardware, software,
...

p.001699:
p.001699: TITLE XXXIII—WORLD TRADE CENTER HEALTH PROGRAM
p.001699: Subtitle A—Establishment of Program; Advisory Committee
p.001699:
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p.001699: January 30, 2020
p.001699: SEC. 3301. ø42 U.S.C. 300mm¿ ESTABLISHMENT OF WORLD TRADE CEN- TER HEALTH PROGRAM.
p.001699: (a) IN GENERAL.—There is hereby established within the De- partment of Health and Human Services a
p.001699: program to be known as the World Trade Center Health Program, which shall be admin-
p.001699: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001699:
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p.001701: 1701
p.001701: PUBLIC HEALTH SERVICE ACT
p.001701: Sec. 3301
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p.001701: January 30, 2020
p.001701: istered by the WTC Program Administrator, to provide beginning on July 1, 2011—
p.001701: (1) medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup
p.001701: workers (in- cluding those who are Federal employees) who responded to the September 11, 2001, terrorist
p.001701: attacks; and
p.001701: (2) initial health evaluation, monitoring, and treatment benefits to residents and other building occupants
p.001701: and area workers in New York City who were directly impacted and ad- versely affected by such attacks.
p.001701: (b) COMPONENTS OF PROGRAM.—The WTC Program includes the following components:
p.001701: (1) MEDICAL MONITORING FOR RESPONDERS.—Medical moni- toring under section 3311, including clinical examinations and
p.001701: long-term health monitoring and analysis for enrolled WTC re- sponders who were likely to have been exposed to airborne
p.001701: tox- ins that were released, or to other hazards, as a result of the September 11, 2001, terrorist attacks.
p.001701: (2) INITIAL HEALTH EVALUATION FOR SURVIVORS.—An ini- tial health evaluation under section 3321, including an
p.001701: evalua- tion to determine eligibility for followup monitoring and treat- ment.
p.001701: (3) FOLLOWUP MONITORING AND TREATMENT FOR WTC-RE- LATED HEALTH CONDITIONS FOR RESPONDERS AND
p.001701: SURVIVORS.—
p.001701: Provision under sections 3312, 3322, and 3323 of followup monitoring and treatment and payment, subject
p.001701: to the provi- sions of subsection (d), for all medically necessary health and mental health care expenses of
p.001701: an individual with respect to a WTC-related health condition (including necessary prescription drugs).
p.001701: (4) OUTREACH.—Establishment under section 3303 of an education and outreach program to potentially eligible
...

p.001713: number of enrollments of WTC responders has reached 80 percent of the limit described in paragraph (4) or on or after
p.001713: the date that the number of certifications for certified-eligible WTC survivors under section 3321(a)(2)(B) has
p.001713: reached 80 per- cent of the limit described in section 3321(a)(3).
p.001713: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001713:
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p.001713: Sec. 3311 PUBLIC HEALTH SERVICE ACT 1714
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p.001713: January 30, 2020
p.001713:
p.001713: (2) CURRENT ELIGIBILITY CRITERIA.—The eligibility criteria described in this paragraph for an individual is
p.001713: that the indi- vidual is described in any of the following categories:
p.001713: (A) FIREFIGHTERS AND RELATED PERSONNEL.—The in- dividual—
p.001713: (i) was a member of the Fire Department of New York City (whether fire or emergency personnel, active or
p.001713: retired) who participated at least one day in the rescue and recovery effort at any of the former
p.001713: World Trade Center sites (including Ground Zero, Staten Is- land Landfill, and the New York City Chief
p.001713: Medical Examiner’s Office) for any time during the period be- ginning on September 11, 2001, and ending
p.001713: on July 31, 2002; or
p.001713: (ii)(I) is a surviving immediate family member of an individual who was a member of the Fire Depart-
p.001713: ment of New York City (whether fire or emergency personnel, active or retired) and was killed at the
p.001713: World Trade site on September 11, 2001; and
p.001713: (II) received any treatment for a WTC-related health condition described in section 3312(a)(1)(A)(ii)
p.001713: (relating to mental health conditions) on or before Sep- tember 1, 2008.
p.001713: (B) LAW ENFORCEMENT OFFICERS AND WTC RESCUE, RE- COVERY, AND CLEANUP WORKERS.—The individual—
p.001713: (i) worked or volunteered onsite in rescue, recov- ery, debris cleanup, or related support services
p.001713: in lower Manhattan (south of Canal St.), the Staten Is- land Landfill, or the barge loading piers, for
p.001713: at least 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001, for at
p.001713: least
p.001713: 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, or for at least
p.001713: 80 hours during the period beginning on Sep- tember 11, 2001, and ending on July 31, 2002;
p.001713: (ii)(I) was a member of the Police Department of New York City (whether active or retired) or a mem-
p.001713: ber of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or
p.001713: re- tired) who participated onsite in rescue, recovery, de- bris cleanup, or related services in lower
p.001713: Manhattan (south of Canal St.), including Ground Zero, the Stat- en Island Landfill, or the barge loading
p.001713: piers, for at least 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001;
...

p.001715: St.) for at least 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002;
p.001715: (iii) was an employee of the Office of the Chief Medical Examiner of New York City involved in the
p.001715: examination and handling of human remains from the World Trade Center attacks, or other morgue worker who
p.001715: performed similar post-September 11 functions for such Office staff, during the period beginning on
p.001715: September 11, 2001, and ending on July 31, 2002;
p.001715: (iv) was a worker in the Port Authority Trans- Hudson Corporation Tunnel for at least 24 hours dur- ing the
p.001715: period beginning on February 1, 2002, and ending on July 1, 2002; or
p.001715: (v) was a vehicle-maintenance worker who was ex- posed to debris from the former World Trade Center while
p.001715: retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from
p.001715: the September 11, 2001, terrorist attacks during a duration and period described in subparagraph (A).
p.001715: (C) RESPONDERS TO THE SEPTEMBER 11 ATTACKS AT THE PENTAGON AND SHANKSVILLE, PENNSYLVANIA.—The indi-
p.001715: vidual—
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p.001715: January 30, 2020
p.001715: (i)(I) was a member of a fire or police department (whether fire or emergency personnel, active or re- tired),
p.001715: worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, dem- olition,
p.001715: debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of
p.001715: September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the
p.001715: cleanup of the site was concluded, as determined by the WTC Program Administrator; or
p.001715: (II) was a member of a fire or police department (whether fire or emergency personnel, active or re-
p.001715: tired), worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, dem-
p.001715: olition, debris cleanup, or other related services at the Shanksville, Pennsylvania, site of the terrorist-related
p.001715: aircraft crash of September 11, 2001, during the pe- riod beginning on September 11, 2001, and ending
p.001715: on the date on which the cleanup of the site was con- cluded, as determined by the WTC Program
p.001715: Adminis- trator; and
p.001715: (ii) is determined by the WTC Program Adminis- trator to be at an increased risk of developing a WTC- related
p.001715: health condition as a result of exposure to air- borne toxins, other hazards, or adverse conditions re- sulting
p.001715: from the September 11, 2001, terrorist attacks, and meets such eligibility criteria related to such expo-
p.001715: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001715:
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p.001715: Sec. 3311 PUBLIC HEALTH SERVICE ACT 1716
p.001715:
p.001715: sures, as the WTC Program Administrator determines are appropriate, after consultation with the WTC Sci-
p.001715: entific/Technical Advisory Committee.
p.001715: (3) ENROLLMENT PROCESS.—
p.001715: (A) IN GENERAL.—The WTC Program Administrator shall establish a process for enrolling WTC responders in
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General/Other / Relationship to Authority

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p.000001: (j) The term ‘‘habit-forming narcotic drug’’ or ‘‘narcotic’’ means opium and coca leaves and the several alkaloids
p.000001: derived therefrom, the best known of these alkaloids being morphia, heroin, and co- deine, obtained from
p.000001: opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives
p.000001: ob- tained either from the raw material or from the various alkaloids; Indian hemp and its various
p.000001: derivatives, compounds, and prepara- tions, and peyote in its various forms; isonipecaine and its deriva-
p.000001: 1
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: Sec. 201 PUBLIC HEALTH SERVICE ACT 2
p.000001:
p.000001: tives, compounds, salts and preparations; opiates (as defined in sec- tion 3228(f) of the Internal Revenue Code);
p.000001: (k) The term ‘‘addict’’ means any person who habitually uses any habit-forming narcotic drugs so as to
p.000001: endanger the public mor- als, health, safety, or welfare, or who is or has been so far addicted to the use of such
p.000001: habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
p.000001: (l) The term ‘‘psychiatric disorders’’ includes diseases of the nervous system which affect mental health;
p.000001: (m) The term ‘‘State mental health authority’’ means the State health authority, except that, in the case of
p.000001: any State in which there is a single State agency, other than the State health author- ity, charged with
p.000001: responsibility for administering the mental health program of the State, it means such other State agency;
p.000001: (n) The term ‘‘heart diseases’’ means diseases of the heart and circulation;
p.000001: (o) The term ‘‘dental diseases and conditions’’ means diseases and conditions affecting teeth and their
p.000001: supporting structures, and other related diseases of the mouth;
p.000001: (p) The term ‘‘uniformed service’’ means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health
p.000001: Service, or Coast and Geodetic Survey; and
p.000001: (q) The term ‘‘drug dependent person’’ means a person who is using a controlled substance (as defined in
p.000001: section 102 of the Con- trolled Substances Act) and who is in a state of psychic or physical dependence, or both,
p.000001: arising from the use of that substance on a continuous basis. Drug dependence is characterized by
p.000001: behavioral and other responses which include a strong compulsion to take the substance on a continuous basis in
p.000001: order to experience its psychic effects or to avoid the discomfort caused by its absence.
...

p.000001: SEC. 212. ø213¿ (a) Except as provided in subsection (b), com- missioned officers of the Service and their
p.000001: surviving beneficiaries shall, with respect to active service performed by such officers—
p.000001: (1) in time of war;
p.000001: (2) on detail for duty with the Army, Navy, Air Force, Ma- rine Corps, or Coast Guard; or
p.000001: (3) while the Service is part of the military forces of the United States pursuant to Executive order of the
p.000001: President;
p.000001: be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law
p.000001: of the United States in the case of commissioned officers of the Army or their surviving bene- ficiaries
p.000001: on account of active military service, except retired pay and uniform allowances.
p.000001: (b) The President may prescribe the conditions under which commissioned officers of the Service may be
p.000001: awarded military rib- bons, medals, and decorations.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001: Sec. 213 PUBLIC HEALTH SERVICE ACT 20
p.000001:
p.000001: (c) The authority vested by law in the Department of the Army, the Secretary of the Army, or other
p.000001: officers of the Depart- ment of the Army with respect to rights, privileges, immunities, and benefits
p.000001: referred to in subsection (a) shall be exercised, with respect to commissioned officers of the Service,
p.000001: by the Surgeon General.
p.000001: (d) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all laws administered by the Sec- retary of Veterans
p.000001: Affairs (except the Servicemen’s Indemnity Act of 1951) and section 217 of the Social Security Act.
p.000001: (e) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or
p.000001: hereafter provided under the Servicemembers Civil Relief Act (50 App. U.S.C. 501 et seq.).
p.000001: (f) Active service of commissioned officers of the Service shall be deemed to be active military service in
p.000001: the Armed Forces of the United States for purposes of all laws related to discrimination on the basis of race,
...

p.000001: present a United States flag to the officer.
p.000001: (b) MULTIPLE PRESENTATIONS NOT AUTHORIZED.—An officer is not eligible for presentation of a flag under subsection
p.000001: (a) if the of- ficer has previously been presented a flag under this section or any other provision of law
p.000001: providing for the presentation of a United States flag incident to release from active service for retirement.
p.000001: (c) NO COST TO RECIPIENT.—The presentation of a flag under this section shall be at no cost to the recipient.
p.000001: DETAIL OF PERSONNEL
p.000001: SEC. 214. 7 ø215¿ (a) The Secretary is authorized, upon the re- quest of the head of an executive department,
p.000001: to detail officers or employees of the Service to such department for duty as agreed upon by the
p.000001: Secretary and the head of such department in order to cooperate in, or conduct work related to, the
p.000001: functions of such department or of the Service. When officers or employees are so de- tailed their salaries and
p.000001: allowances may be paid from working funds established as provided by law or may be paid by the Service from
p.000001: applicable appropriation and reimbursement may be made as agreed upon by the Secretary and the head of the executive
p.000001: depart- ment concerned. Officers detailed for duty with the Army, Navy, or Coast Guard shall be subject to the laws for
p.000001: the government of the service to which detailed.
p.000001: (b) Upon the request of any State health authority or, in the case of work relating to mental health, any
p.000001: State mental health au-
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 7 Former section 213 was repealed by section 14 of Public Law 87–649 (76 Stat. 499). Section 415(c) of title 37, United
p.000001: States Code, now applies to the matter with which former section 213 was concerned.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 21 PUBLIC HEALTH SERVICE ACT Sec. 216
p.000001:
p.000001: thority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such
p.000001: State or political subdivi- sion thereof in work related to the functions of the Service.
p.000001: (c) The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to
p.000001: nonprofit edu- cational research or other institutions engaged in health activities for special studies of
p.000001: scientific problems and for the dissemination of information relating to public health.
p.000001: (d) Personnel detailed under subsections (b) and (c) shall be paid from applicable appropriations of the
p.000001: Service except that, in accordance with regulations such personnel may be placed on leave without pay and paid
p.000001: by the State, subdivision, or institution to which they are detailed. In the case of detail of
p.000001: personnel under subsections (b) or (c) to be paid from applicable Service appropria- tions, the Secretary may
p.000001: condition such detail on an agreement by the State, subdivision, or institution concerned that such State,
p.000001: subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by
p.000001: the Service. The services of personnel while detailed pursuant to this section shall be considered as having
p.000001: been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensa-
p.000001: tion for injury or death, and the benefits provided by section 212.
p.000001: (e) Except with respect to the United States Coast Guard and the Department of Defense, and except as
p.000001: provided in agreements negotiated with officials at agencies where officers of the Commis- sioned Corps
p.000001: may be assigned, the Secretary shall have the sole authority to deploy any Commissioned Corps officer assigned
p.000001: under this section to an entity outside of the Department of Health and Human Services for service under
p.000001: the Secretary’s direction in re- sponse to an urgent or emergency public health care need (as de- fined
p.000001: in section 203A(a)(5)).
p.000001:
p.000001: REGULATIONS
p.000001: SEC. 215. ø216¿ (a) The President shall from time to time pre- scribe regulations with respect to the
p.000001: appointment, promotion, re- tirement, termination of commission, title, pay, uniforms, allow- ances
p.000001: (including increased allowances for foreign service), and dis- cipline of the commissioned corps of the Service.
p.000001: (b) The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall
p.000001: promulgate all other regulations necessary to the administration of the Service, includ- ing regulations
p.000001: with respect to uniforms for employees, and regula- tions with respect to the custody, use, and preservation
p.000001: of the records, papers, and property of the Service.
p.000001: (c) No regulations relating to qualifications for appointment of medical officers or employees shall give preference to
p.000001: any school of medicine.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: USE OF SERVICE IN TIME OF WAR OR EMERGENCY
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p.000001: military benefits under section 212 of this Act.
p.000001: (9) Section 2603, Acceptance of fellowships, scholarships, or grants.
p.000001: (10) Section 2634 Motor vehicles: for members on perma- nent change of station.
p.000001: (11) Section 1035, Deposit of savings.
p.000001: (12) Section 1552, Correction of military records: claims in- cident thereto.
p.000001: (13) Section 1553, Review of discharge or dismissal.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 25 PUBLIC HEALTH SERVICE ACT Sec. 223
p.000001:
p.000001: (14) Section 1554, Review of retirement or separation with- out pay for physical disability.
p.000001: (15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
p.000001: (16) Section 1052, Reimbursement for adoption expenses.
p.000001: (17) Section 1059, Transitional compensation and com- missary and exchange benefits for dependents of members
p.000001: sep- arated for dependent abuse.
p.000001: (18) Section 1034, Protected Communications; Prohibition of Retaliatory Personnel Actions.
p.000001: (b) The authority vested by title 10, United States Code, in the ‘‘military departments’’, ‘‘the Secretary
p.000001: concerned’’, or ‘‘the Sec- retary of Defense’’ with respect to the rights, privileges, immuni- ties, and
p.000001: benefits referred to in subsection (a) shall be exercised, with respect to commissioned officers of the
p.000001: Service, by the Sec- retary of Health, Education, and Welfare or his designee. For pur- poses of paragraph (18) of
p.000001: subsection (a), the term ‘‘Inspector Gen- eral’’ in section 1034 of such title 10 shall mean the Inspector Gen- eral of
p.000001: the Department of Health and Human Services.
p.000001: ADVISORY COUNCILS OR COMMITTEES
p.000001: SEC. 222. ø217a¿ (a) The Secretary may, without regard to the provisions of title 5, United States Code,
p.000001: governing appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000001: subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, from time
p.000001: to time, appoint such advisory councils or committees (in addition to those authorized to be established
p.000001: under other provisions of law), for such periods of time, as he deems desirable with such period com- mencing on a
p.000001: date specified by the Secretary for the purpose of ad- vising him in connection with any of his functions.
p.000001: (b) Members of any advisory council or committee appointed under this section who are not regular
p.000001: full-time employees of the United States shall, while attending meetings or conferences of such council or
...

p.000001: (4) of subsection (h).
p.000001: (E) The Secretary shall make a determination of whether an entity or an officer, governing board member,
p.000001: employee, or con- tractor of the entity is deemed to be an employee of the Public Health Service for
p.000001: purposes of this section within 30 days after the receipt of an application under subparagraph (D). The
p.000001: determina- tion of the Secretary that an entity or an officer, governing board member, employee, or
p.000001: contractor of the entity is deemed to be an employee of the Public Health Service for purposes of this
p.000001: section shall apply for the period specified by the Secretary under subpara- graph (A).
p.000001: (F) Once the Secretary makes a determination that an entity or an officer, governing board member,
p.000001: employee, or contractor of an entity is deemed to be an employee of the Public Health Service for purposes of
p.000001: this section, the determination shall be final and binding upon the Secretary and the Attorney General
p.000001: and other parties to any civil action or proceeding. Except as provided in sub- section (i), the Secretary and the
p.000001: Attorney General may not deter- mine that the provision of services which are the subject of such a
p.000001: determination are not covered under this section.
p.000001: (G) In the case of an entity described in paragraph (4) that has not submitted an application under subparagraph (D):
p.000001: (i) The Secretary may not consider the entity in making es- timates under subsection (k)(1).
p.000001: (ii) This section does not affect any authority of the entity to purchase medical malpractice liability insurance
p.000001: coverage with Federal funds provided to the entity under section 329, 330, or 340A.
p.000001: (H) In the case of an entity described in paragraph (4) for which an application under subparagraph (D) is
p.000001: in effect, the entity may, through notifying the Secretary in writing, elect to terminate the applicability of this
p.000001: subsection to the entity. With respect to such election by the entity:
p.000001: (i) The election is effective upon the expiration of the 30- day period beginning on the date on which
p.000001: the entity submits such notification.
p.000001: (ii) Upon taking effect, the election terminates the applica- bility of this subsection to the entity and each
p.000001: officer, gov- erning board member, employee, and contractor of the entity.
p.000001: (iii) Upon the effective date for the election, clauses (i) and
p.000001: (ii) of subparagraph (G) apply to the entity to the same extent and in the same manner as such clauses apply
p.000001: to an entity that has not submitted an application under subparagraph (D).
p.000001: (iv) If after making the election the entity submits an ap- plication under subparagraph (D), the
p.000001: election does not pre-
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
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p.000001: 29 PUBLIC HEALTH SERVICE ACT Sec. 224
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p.000001:
p.000001: Sec. 224 PUBLIC HEALTH SERVICE ACT 30
p.000001: (i)(1) Notwithstanding subsection (g)(1), the Attorney General, in consultation with the Secretary, may on
p.000001: the record determine, after notice and opportunity for a full and fair hearing, that an in- dividual physician or
p.000001: other licensed or certified health care practi- tioner who is an officer, employee, or contractor of an
p.000001: entity de- scribed in subsection (g)(4) shall not be deemed to be an employee of the Public Health Service for
p.000001: purposes of this section, if treating such individual as such an employee would expose the Government to an
p.000001: unreasonably high degree of risk of loss because such indi- vidual—
p.000001: (A) does not comply with the policies and procedures that the entity has implemented pursuant to subsection
p.000001: (h)(1);
p.000001: (B) has a history of claims filed against him or her as pro- vided for under this section that is outside the
p.000001: norm for li- censed or certified health care practitioners within the same specialty;
p.000001: (C) refused to reasonably cooperate with the Attorney Gen- eral in defending against any such claim;
p.000001: (D) provided false information relevant to the individual’s performance of his or her duties to the Secretary,
p.000001: the Attorney General, or an applicant for or recipient of funds under this Act; or
p.000001: (E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national
p.000001: professional society.
p.000001: (2) A final determination by the Attorney General under this subsection that an individual physician or
p.000001: other licensed or cer- tified health care professional shall not be deemed to be an em- ployee of the
p.000001: Public Health Service shall be effective upon receipt by the entity employing such individual of notice
p.000001: of such deter- mination, and shall apply only to acts or omissions occurring after the date such notice is received.
p.000001: (j) In the case of a health care provider who is an officer, em- ployee, or contractor of an entity
p.000001: described in subsection (g)(4), sec- tion 335(e) shall apply with respect to the provider to the same ex- tent and in
p.000001: the same manner as such section applies to any mem- ber of the National Health Service Corps.
p.000001: (k)(1)(A) For each fiscal year, the Attorney General, in con- sultation with the Secretary, shall estimate by
p.000001: the beginning of the year the amount of all claims which are expected to arise under this section
p.000001: (together with related fees and expenses of witnesses) for which payment is expected to be made in
p.000001: accordance with sec- tion 1346 and chapter 171 of title 28, United States Code, from the acts or omissions, during
p.000001: the calendar year that begins during that fiscal year, of entities described in subsection (g)(4) and of officers,
p.000001: employees, or contractors (subject to subsection (g)(5)) of such enti- ties.
p.000001: (B) The estimate under subparagraph (A) shall take into ac- count—
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
...

p.000001: (7)(A) This subsection takes effect on the date of the enactment of the first appropriations Act that makes an
p.000001: appropriation under paragraph (6)(A), except as provided in subparagraph (B)(i).
p.000001: (B)(i) Effective on the date of the enactment of the Health In- surance Portability and Accountability Act
p.000001: of 1996—
p.000001: (I) the Secretary may issue regulations for carrying out this subsection, and the Secretary may accept and
p.000001: consider ap- plications submitted pursuant to paragraph (5)(C); and
p.000001: (II) reports under paragraph (6)(C) may be submitted to the Congress.
p.000001: (ii) For the first fiscal year for which an appropriation is made under subparagraph (A) of paragraph (6), if an
p.000001: estimate under sub- paragraph (C) of such paragraph has not been made for the cal- endar year beginning
p.000001: in such fiscal year, the transfer under sub- paragraph (D) of such paragraph shall be made
p.000001: notwithstanding the lack of the estimate, and the transfer shall be made in an amount equal to the amount
p.000001: of such appropriation.
p.000001: (p) ADMINISTRATION OF SMALLPOX COUNTERMEASURES BY
p.000001: HEALTH PROFESSIONALS.—
p.000001: (1) IN GENERAL.—For purposes of this section, and subject to other provisions of this subsection, a covered person
p.000001: shall be deemed to be an employee of the Public Health Service with respect to liability arising out of
p.000001: administration of a covered countermeasure against smallpox to an individual during the effective period of
p.000001: a declaration by the Secretary under para- graph (2)(A).
p.000001: (2) DECLARATION BY SECRETARY CONCERNING COUNTER- MEASURE AGAINST SMALLPOX.—
p.000001: (A) AUTHORITY TO ISSUE DECLARATION.—
p.000001: (i) IN GENERAL.—The Secretary may issue a dec- laration, pursuant to this paragraph, concluding that an
p.000001: actual or potential bioterrorist incident or other ac- tual or potential public health emergency makes ad-
p.000001: visable the administration of a covered counter- measure to a category or categories of individuals.
p.000001: (ii) COVERED COUNTERMEASURE.—The Secretary shall specify in such declaration the substance or sub- stances
p.000001: that shall be considered covered counter- measures (as defined in paragraph (7)(A)) for purposes of
p.000001: administration to individuals during the effective period of the declaration.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: 37 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: (iii) EFFECTIVE PERIOD.—The Secretary shall specify in such declaration the beginning and ending
p.000001: dates of the effective period of the declaration, and may subsequently amend such declaration to shorten
p.000001: or extend such effective period, provided that the new closing date is after the date when the declaration is
p.000001: amended.
p.000001: (iv) PUBLICATION.—The Secretary shall promptly publish each such declaration and amendment in the Federal
p.000001: Register.
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p.000001: January 30, 2020
p.000001: mit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by
p.000001: section 44H of the Inter- nal Revenue Code of 1954; and the Secretary of Health and Human Services shall submit
p.000001: to the Board for inclusion in the annual re- port a report on the program of assistance under section
p.000001: 5 of the Orphan Drug Act for the development of drugs for rare diseases and conditions. Each annual
p.000001: report shall be submitted by June 1 of each year for the preceding calendar year.
p.000001: SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE
p.000001: SEC. 228. ø237¿ (a)(1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical
p.000001: Research and Bio- medical Product Assessment Service (in this section referred to as the ‘‘Service’’), not
p.000001: to exceed 2,000 members, the purpose of which is to recruit and retain outstanding and qualified
p.000001: scientific and technical experts in the fields of biomedical research, clinical re- search evaluation, and
p.000001: biomedical product assessment.
p.000001: (2) The authority established in paragraph (1) may not be con- strued to require the Secretary to reduce the number of
p.000001: employees serving under any other employment system in order to offset the number of members serving in the
p.000001: Service.
p.000001: (3) The Secretary shall assign experts under this section to agencies within the Department of Health
p.000001: and Human Services taking into account the need for the expertise of such expert.
p.000001: (b) The Service shall be appointed by the Secretary without re- gard to the provisions of title 5, United States Code,
p.000001: regarding ap- pointment, and shall consist of individuals outstanding in the field of biomedical research, clinical
p.000001: research evaluation, or biomedical product assessment. No individual may be appointed to the Service unless such
p.000001: individual (1) has earned a doctoral level degree in bio- medicine or a related field, or a doctoral or
p.000001: master’s level degree in engineering, bioinformatics, or a related or emerging field, and
p.000001: (2) meets the qualification standards prescribed by the Office of Personnel Management for appointment to
p.000001: a position at GS–15 of the General Schedule. Notwithstanding any previous applicability to an individual who
p.000001: is a member of the Service, the provisions of subchapter I of chapter 35 (relating to retention preference), chap- ter
p.000001: 43 (relating to performance appraisal and performance actions), chapter 51 (relating to classification),
p.000001: subchapter III of chapter 53 (relating to General Schedule pay rates), and chapter 75 (relating to
p.000001: adverse actions) of title 5, United States Code, shall not apply to any member of the Service.
...

p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001: 49 PUBLIC HEALTH SERVICE ACT Sec. 231
p.000001:
p.000001: (A) facilitate the exchange of information regarding matters relating to health information, health
p.000001: promotion, preventive health services, research advances, and edu- cation in the appropriate use of health care;
p.000001: (B) facilitate access to such information;
p.000001: (C) assist in the analysis of issues and problems relat- ing to the matters described in this paragraph; and
p.000001: (D) provide technical assistance with respect to the ex- change of information (including facilitating the
p.000001: develop- ment of materials for such technical assistance);
p.000001: (6) coordinate efforts to promote women’s health programs and policies with the private sector; and
p.000001: (7) through publications and any other means appropriate, provide for the exchange of information between the Office
p.000001: and recipients of grants, contracts, and agreements under sub- section (c), and between the Office and
p.000001: health professionals and the general public.
p.000001: (c) GRANTS AND CONTRACTS REGARDING DUTIES.—
p.000001: (1) AUTHORITY.—In carrying out subsection (b), the Sec- retary may make grants to, and enter into
p.000001: cooperative agree- ments, contracts, and interagency agreements with, public and private entities, agencies, and
p.000001: organizations.
p.000001: (2) EVALUATION AND DISSEMINATION.—The Secretary shall directly or through contracts with public and private
p.000001: entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance
p.000001: provided under paragraph
p.000001: (1) and for the dissemination of information developed as a re- sult of such projects.
p.000001: (d) REPORTS.—Not later than 1 year after the date of enact- ment of this section, and every second
p.000001: year thereafter, the Sec- retary shall prepare and submit to the appropriate committees of Congress a
p.000001: report describing the activities carried out under this section during the period for which the report is being
p.000001: prepared.
p.000001: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000001: to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000001: PART B—MISCELLANEOUS PROVISIONS
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001: January 30, 2020
p.000001:
p.000001: GIFTS
p.000001: SEC. 231. ø238¿ (a) The Secretary is authorized to accept on behalf of the United States gifts made
p.000001: unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of
p.000001: its functions. Conditional gifts may be so accepted if rec- ommended by the Surgeon General, and the
p.000001: principal of and in- come from any such conditional gift shall be held, invested, rein- vested, and used
p.000001: in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not
p.000001: to be met therefrom or from the income thereof unless such expenditure has been approved by Act of Congress.
p.000001: (b) Any unconditional gift of money accepted, pursuant to the authority granted in subsection (a) of this
p.000001: section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
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p.000001:
p.000001: Sec. 232 PUBLIC HEALTH SERVICE ACT 50
p.000001:
p.000001: this section) of any other property so accepted, and the proceeds of insurance on any such gift property not
p.000001: used for its restoration, shall be deposited in the Treasury of the United States and are hereby
p.000001: appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may
p.000001: invest and reinvest such funds in interest-bearing obligations of the United States or in obligations
p.000001: guaranteed as to both principal and inter- est by the United States. Such gifts and the income from
p.000001: such in- vestments shall be available for expenditure in the operation of the Service and the performance of its
p.000001: functions, subject to the same examination and audit as is provided for appropriations made for the
p.000001: Service by Congress.
p.000001: (c) The evidences of any unconditional gift of intangible per- sonal property, other than money, accepted
p.000001: pursuant to the author- ity granted in subsection (a) of this section shall be deposited with the Secretary of the
...

p.000017: by memorials, des- ignations, or other suitable acknowledgments), (1) efforts of persons who have contributed
p.000017: substantially to the health of the Nation and
p.000017: (2) gifts for use in activities of the Department related to health.
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017: January 30, 2020
p.000017:
p.000017: EVALUATION OF PROGRAMS
p.000017: SEC. 241. ø238j¿ (a) IN GENERAL.—Such portion as the Sec- retary shall determine, but not less than 0.2
p.000017: percent nor more than
p.000017: 1 percent, of any amounts appropriated for programs authorized under this Act shall be made available for the
p.000017: evaluation (directly, or by grants of contracts) of the implementation and effectiveness of such programs.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 53 PUBLIC HEALTH SERVICE ACT Sec. 243
p.000017:
p.000017: (b) REPORT ON EVALUATIONS.—Not later than February 1 of each year, the Secretary shall prepare and
p.000017: submit to the Com- mittee on Labor and Human Resources of the Senate and the Com- mittee on Energy and Commerce
p.000017: of the House of Representatives a report summarizing the findings of the evaluations conducted under
p.000017: subsection (a).
p.000017: CONTRACT AUTHORITY
p.000017: SEC. 242. ø238k¿ The authority of the Secretary to enter into contracts under this Act shall be
p.000017: effective for any fiscal year only to such extent or in such amounts as are provided in advance by
p.000017: appropriation Acts.
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p.000017: January 30, 2020
p.000017: RECOVERY
p.000017: SEC. 243. ø238l¿ (a) If any facility with respect to which funds have been paid under the Community Mental
p.000017: Health Centers Act (as such Act was in effect prior to October 1, 1981) is, at any time within twenty years after
p.000017: the completion of remodeling, construc- tion, or expansion or after the date of its acquisition—
p.000017: (1) sold or transferred to any entity (A) which would not have been qualified to file an application
p.000017: under section 222 of such Act (as such section was in effect prior to October 1, 1981) or (B) which is disapproved
p.000017: as a transferee by the State mental health agency or by another entity designated by the chief ex- ecutive officer of
p.000017: the State, or
p.000017: (2) ceases to be used by a community mental health center in the provision of comprehensive mental health services,
p.000017: the United States shall be entitled to recover from the transferor, transferee, or owner of the facility, the
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p.000017: (d) The Secretary may waive the recovery rights of the United States under subsection (a) with respect to a
p.000017: facility (under such conditions as the Secretary may establish by regulation) if the Sec- retary determines that
p.000017: there is good cause for waiving such rights.
p.000017: (e) The right of recovery of the United States under subsection
p.000017: (a) shall not, prior to judgment, constitute a lien on any facility.
p.000017: USE OF FISCAL AGENTS
p.000017: SEC. 244. ø238m¿ (a) The Secretary may enter into contracts with fiscal agents—
p.000017: (1)(A) to determine the amounts payable to persons who, on behalf of the Indian Health Service, furnish health
p.000017: services to eligible Indians,
p.000017: (B) to determine the amounts payable to persons who, on behalf of the Public Health Service, furnish
p.000017: health services to individuals pursuant to section 319 or 322,
p.000017: (2) to receive, disburse, and account for funds in making payments described in paragraph (1),
p.000017: (3) to make such audits of records as may be necessary to assure that these payments are proper, and
p.000017: (4) to perform such additional functions as may be nec- essary to carry out the functions described in
p.000017: paragraphs (1) through (3).
p.000017: (b)(1) Contracts under subsection (a) may be entered into with- out regard to section 3709 of the Revised Statutes (41
p.000017: U.S.C. 5) or any other provision of law requiring competition.
p.000017: (2) No such contract shall be entered into with an entity unless the Secretary finds that the entity will
p.000017: perform its obligations under the contract efficiently and effectively and will meet such re- quirements as to
p.000017: financial responsibility, legal authority, and other matters as he finds pertinent.
p.000017: (c) A contract under subsection (a) may provide for advances of funds to enable entities to make
p.000017: payments under the contract.
p.000017: (d) Subsections (d) and (e) of section 1842 of the Social Security Act shall apply to contracts with entities
p.000017: under subsection (a) in the same manner as they apply to contracts with carriers under that section.
p.000017: (e) In this section, the term ‘‘fiscal agent’’ means a carrier de- scribed in section 1842(f)(1) of the
p.000017: Social Security Act and includes, with respect to contracts under subsection (a)(1)(A), an Indian tribe or tribal
p.000017: organization acting under contract with the Secretary under the Indian Self-Determination Act (Public Law
p.000017: 93–638).
p.000017:
p.000017:
p.000017: January 30, 2020 As Amended Through P.L. 116-94,
p.000017: Enacted December 20, 2019
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p.000017: 55 PUBLIC HEALTH SERVICE ACT Sec. 245
p.000017:
p.000017: ABORTION-RELATED DISCRIMINATION IN GOVERNMENTAL ACTIVITIES REGARDING TRAINING AND LICENSING OF PHYSICIANS
p.000017: SEC. 245. ø238n¿ (a) IN GENERAL.—The Federal Government, and any State or local government that receives
p.000017: Federal financial assistance, may not subject any health care entity to discrimination on the basis that—
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p.000017: Sec. 263 PUBLIC HEALTH SERVICE ACT 62
p.000017:
p.000017: (1) in the case of a request based on the administration of the vaccine to the individual, the individual files with
p.000017: the Sec- retary an initial request for benefits or compensation under this part not later than one year after
p.000017: the date of administra- tion of the vaccine; or
p.000017: (2) in the case of a request based on accidental vaccinia in- oculation, the individual files with the Secretary
p.000017: an initial re- quest for benefits or compensation under this part not later than two years after the
p.000017: date of the first symptom or mani- festation of onset of the adverse effect.
p.000017: (e) STRUCTURED SETTLEMENTS AT SECRETARY’S OPTION.—In any case in which there is a reasonable
p.000017: likelihood that compensa- tion or payment under section 264, 265, or 266(b) will be required for a period in
p.000017: excess of one year from the date an individual is determined eligible for such compensation or payment,
p.000017: the Sec- retary shall have the discretion to make a lump-sum payment, pur- chase an annuity or medical insurance
p.000017: policy, or execute an appro- priate structured settlement agreement, provided that such pay- ment, annuity,
p.000017: policy, or agreement is actuarially determined to have a value equal to the present value of the
p.000017: projected total amount of benefits or compensation that the individual is eligible to receive under such
p.000017: section or sections.
p.000017: (f) REVIEW OF DETERMINATION.—
p.000017: (1) SECRETARY’S REVIEW AUTHORITY.—The Secretary may review a determination under this section at any
p.000017: time on the Secretary’s own motion or on application, and may affirm, va- cate, or modify such
p.000017: determination in any manner the Sec- retary deems appropriate. The Secretary shall develop a proc- ess by
p.000017: which an individual may file a request for reconsider- ation of any determination made by the Secretary
p.000017: under this section.
p.000017: (2) JUDICIAL AND ADMINISTRATIVE REVIEW.—No court of the United States, or of any State, District, territory or
p.000017: possession thereof, shall have subject matter jurisdiction to review, whether by mandamus or
p.000017: otherwise, any action by the Sec- retary under this section. No officer or employee of the United States shall
p.000017: review any action by the Secretary under this sec- tion (unless the President specifically directs otherwise).
p.000017: SEC. 263. ø239b¿ SMALLPOX VACCINE INJURY TABLE.
p.000017: (a) 21 SMALLPOX VACCINE INJURY TABLE.—
p.000017: (1) ESTABLISHMENT REQUIRED.—The Secretary shall estab- lish by interim final regulation a table identifying
p.000017: adverse ef- fects (including injuries, disabilities, illnesses, conditions, and deaths) that shall be
p.000017: presumed to result from the administra- tion of (or exposure to) a smallpox vaccine, and the time period in which
p.000017: the first symptom or manifestation of onset of each such adverse effect must manifest in order for
p.000017: such presump- tion to apply.
p.000017: (2) AMENDMENTS.—The Secretary may by regulation amend the table established under paragraph (1).
p.000017: An amend-
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p.000017: January 30, 2020
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p.000017: agency.
p.000017: (b) REGULATIONS.—The head of the agency administering this part or provisions thereof (including any
p.000017: agency head admin- istering such Act or provisions through a Memorandum of Agree- ment under subsection
p.000017: (a)) may promulgate such implementing regulations as may be found necessary and appropriate. Initial im- plementing
p.000017: regulations may be interim final regulations.
p.000017: SEC. 268. ø239g¿ AUTHORIZATION OF APPROPRIATIONS.
p.000017: For the purpose of carrying out this part, there are authorized to be appropriated such sums as may be necessary for
p.000017: each of the fiscal years 2003 through 2007, to remain available until expended, including administrative costs and
p.000017: costs of provision and payment of benefits. The Secretary’s payment of any benefit under section 264,
p.000017: 265, or 266 shall be subject to the availability of appropria- tions under this section.
p.000017: SEC. 269. ø239h¿ RELATIONSHIP TO OTHER LAWS.
p.000017: Except as explicitly provided herein, nothing in this part shall be construed to override or limit any rights an
p.000017: individual may have to seek compensation, benefits, or redress under any other provi- sion of Federal or State
p.000017: law.
p.000017:
p.000017: PART D—UNITED STATES PUBLIC HEALTH SCIENCES TRACK
p.000017: SEC. 271. ø239l¿ ESTABLISHMENT.
p.000017: (a) UNITED STATES PUBLIC HEALTH SERVICES TRACK.—
p.000017: (1) IN GENERAL.—There is hereby authorized to be estab- lished a United States Public Health Sciences
p.000017: Track (referred to in this part as the ‘‘Track’’), at sites to be selected by the Secretary, with
p.000017: authority to grant appropriate advanced de- grees in a manner that uniquely emphasizes team-based serv- ice,
p.000017: public health, epidemiology, and emergency preparedness and response. It shall be so organized as to
p.000017: graduate not less than—
p.000017:
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p.000017: January 30, 2020
p.000017: (A) 150 medical students annually, 10 of whom shall be awarded studentships to the Uniformed Services
p.000017: Uni- versity of Health Sciences;
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 272 PUBLIC HEALTH SERVICE ACT 68
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p.000017: (B) 100 dental students annually;
p.000017: (C) 250 nursing students annually;
p.000017: (D) 100 public health students annually;
p.000017: (E) 100 behavioral and mental health professional stu- dents annually;
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p.000017: under salary schedules and granted retirement and other related benefits prescribed by the Secretary so as to
p.000017: place the employees of the
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 69 PUBLIC HEALTH SERVICE ACT Sec. 272
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p.000017: January 30, 2020
p.000017: Track faculty on a comparable basis with the employees of fully accredited schools of the health
p.000017: professions within the United States.
p.000017: (2) TITLES.—The Surgeon General may confer academic ti- tles, as appropriate, upon the members of the faculty.
p.000017: (3) NONAPPLICATION OF PROVISIONS.—The limitations in section 5373 of title 5, United States Code, shall
p.000017: not apply to the authority of the Surgeon General under paragraph (1) to prescribe salary schedules and
p.000017: other related benefits.
p.000017: (c) AGREEMENTS.—The Surgeon General may negotiate agree- ments with agencies of the Federal Government to utilize
p.000017: on a re- imbursable basis appropriate existing Federal medical resources lo- cated in the United States (or locations
p.000017: selected in accordance with section 271(a)(2)). Under such agreements the facilities concerned will retain
p.000017: their identities and basic missions. The Surgeon Gen- eral may negotiate affiliation agreements with
p.000017: accredited univer- sities and health professions training institutions in the United States. Such agreements
p.000017: may include provisions for payments for educational services provided students participating in Department of
p.000017: Health and Human Services educational programs.
p.000017: (d) PROGRAMS.—The Surgeon General may establish the fol- lowing educational programs for Track students:
p.000017: (1) Postdoctoral, postgraduate, and technological programs.
p.000017: (2) A cooperative program for medical, dental, physician assistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students.
p.000017: (3) Other programs that the Surgeon General determines necessary in order to operate the Track in a
p.000017: cost-effective man- ner.
p.000017: (e) CONTINUING MEDICAL EDUCATION.—The Surgeon General shall establish programs in continuing medical education
p.000017: for mem- bers of the health professions to the end that high standards of health care may be maintained
p.000017: within the United States.
p.000017: (f) AUTHORITY OF THE SURGEON GENERAL.—
p.000017: (1) IN GENERAL.—The Surgeon General is authorized—
p.000017: (A) to enter into contracts with, accept grants from, and make grants to any nonprofit entity for the purpose
p.000017: of carrying out cooperative enterprises in medical, dental, physician assistant, pharmacy, behavioral and
p.000017: mental health, public health, and nursing research, consultation, and education;
p.000017: (B) to enter into contracts with entities under which the Surgeon General may furnish the services of such pro-
p.000017: fessional, technical, or clerical personnel as may be nec- essary to fulfill cooperative enterprises
p.000017: undertaken by the Track;
p.000017: (C) to accept, hold, administer, invest, and spend any gift, devise, or bequest of personal property
p.000017: made to the Track, including any gift, devise, or bequest for the sup- port of an academic chair,
p.000017: teaching, research, or dem- onstration project;
p.000017: (D) to enter into agreements with entities that may be utilized by the Track for the purpose of enhancing the ac-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: Sec. 273 PUBLIC HEALTH SERVICE ACT 70
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p.000017: January 30, 2020
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p.000017: tivities of the Track in education, research, and techno- logical applications of knowledge; and
p.000017: (E) to accept the voluntary services of guest scholars and other persons.
p.000017: (2) LIMITATION.—The Surgeon General may not enter into any contract with an entity if the contract would
p.000017: obligate the Track to make outlays in advance of the enactment of budget authority for such outlays.
p.000017: (3) SCIENTISTS.—Scientists or other medical, dental, or nursing personnel utilized by the Track under
p.000017: an agreement described in paragraph (1) may be appointed to any position within the Track and may be
p.000017: permitted to perform such duties within the Track as the Surgeon General may approve.
p.000017: (4) VOLUNTEER SERVICES.—A person who provides vol- untary services under the authority of
p.000017: subparagraph (E) of paragraph (1) shall be considered to be an employee of the Fed- eral Government for the purposes
p.000017: of chapter 81 of title 5, relat- ing to compensation for work-related injuries, and to be an em- ployee of the
p.000017: Federal Government for the purposes of chapter 171 of title 28, relating to tort claims. Such a person
p.000017: who is not otherwise employed by the Federal Government shall not be considered to be a Federal employee
p.000017: for any other purpose by reason of the provision of such services.
p.000017: SEC. 273. ø239l–2¿ STUDENTS; SELECTION; OBLIGATION.
p.000017: (a) STUDENT SELECTION.—
p.000017: (1) IN GENERAL.—Medical, dental, physician assistant, pharmacy, behavioral and mental health, public
p.000017: health, and nursing students at the Track shall be selected under proce- dures prescribed by the Surgeon
p.000017: General. In so prescribing, the Surgeon General shall consider the recommendations of the National Health Care
p.000017: Workforce Commission.
p.000017: (2) PRIORITY.—In developing admissions procedures under paragraph (1), the Surgeon General shall ensure that such
p.000017: pro- cedures give priority to applicant medical, dental, physician as- sistant, pharmacy, behavioral and mental
p.000017: health, public health, and nursing students from rural communities and underrepresented minorities.
p.000017: (b) CONTRACT AND SERVICE OBLIGATION.—
p.000017: (1) CONTRACT.—Upon being admitted to the Track, a med- ical, dental, physician assistant, pharmacy,
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p.000017: 75 PUBLIC HEALTH SERVICE ACT Sec. 301
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p.000017: (I) from a Federal agency outside the Department of Health, Education, and Welfare for the Secretary, or
p.000017: (II) from an entity within the Department of Health, Education, and Welfare to any other entity within the De-
p.000017: partment,
p.000017: to conduct research into, or testing for, the carcinogenicity of substances or to provide information
p.000017: described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity,
p.000017: respectively, have responded to each such request.
p.000017: (5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research,
p.000017: or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or
p.000017: in such amounts as are provided in ad- vance in Appropriation Acts.
p.000017: (c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the
p.000017: identification, control, treat- ment, and prevention of diseases (including tropical diseases) which do
p.000017: not occur to a significant extent in the United States.
p.000017: (d)(1)(A) If a person is engaged in biomedical, behavioral, clin- ical, or other research, in which identifiable,
p.000017: sensitive information is collected (including research on mental health and research on the use and effect
p.000017: of alcohol and other psychoactive drugs), the Sec- retary, in coordination with other agencies, as applicable—
p.000017: (i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are
p.000017: the subjects of such research if the research is funded wholly or in part by the Federal Government; and
p.000017: (ii) may, upon application by a person engaged in research, issue to such person a certificate of
p.000017: confidentiality to protect the privacy of such individuals if the research is not so funded.
p.000017: (B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A)
p.000017: to protect the privacy of individuals described in such subparagraph shall not dis- close or provide to any other
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p.000017: requirements of the United States. The results of studies and investigations of the quantities of narcotic
p.000017: drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to
p.000017: supply the normal and emergency medicinal and scientific re- quirements of the United States, shall be
p.000017: reported not later than the first day of April of each year to the Attorney General, to be used at his
p.000017: discretion in determining manufacturing quotas or im- portation requirements under such Acts.
p.000017: (b) The Surgeon General shall cooperate with States for the
p.000017: purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the
p.000017: States the benefit of his
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017: Sec. 304 PUBLIC HEALTH SERVICE ACT 78
p.000017:
p.000017: experience in the care, treatment, and rehabilitation of narcotic ad- dicts to the end that each State may be
p.000017: encouraged to provide ade- quate facilities and methods for the care and treatment of its nar- cotic addicts.
p.000017: GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND DEMONSTRATIONS IN HEALTH STATISTICS, HEALTH
p.000017: SERVICES, AND HEALTH CARE TECHNOLOGY ASSESSMENT
p.000017: SEC. 304. 1 ø242b¿ (a) The Secretary may, through the Agency for Health Care Policy and Research or the
p.000017: National Center for Health Statistics or using National Research Service Awards or other appropriate
p.000017: authorities, undertake and support training pro- grams to provide for an expanded and continuing supply of individ-
p.000017: uals qualified to perform the research, evaluation, and demonstra- tion projects set forth in section 306 and in title
p.000017: IX.
p.000017: (b) To implement subsection (a) and section 306, the Secretary may, in addition to any other authority which
p.000017: under other provi- sions of this Act or any other law may be used by him to imple- ment such
p.000017: subsection, do the following:
p.000017: (1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health
p.000017: and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize
p.000017: the physical resources of such Department, provide technical assistance and advice, make grants to
p.000017: public and nonprofit private entities and indi- viduals, and, when appropriate, enter into contracts with pub-
p.000017: lic and private entities and individuals.
p.000017: (2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and
p.000017: treat- ment at such facilities.
p.000017: (3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with
p.000017: section 3109 of title 5, United States Code, the assistance and advice of con- sultants from the United States or
p.000017: abroad. The Secretary may for the purpose of carrying out the functions set forth in sec- tions 305, 2
p.000017: 306, and 309, obtain (in accordance with section 3109 of title 5 of the United States Code, but
p.000017: without regard to the limitation in such section on the number of days or the period of service) for each of the
p.000017: centers the services of not more than fifteen experts who have appropriate scientific or professional
p.000017: qualifications.
p.000017: (4) Acquire, construct, improve, repair, operate, and main- tain laboratory, research, and other necessary
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p.000017: suppression of communicable diseases and with respect to other public health matters, shall cooperate with and
p.000017: aid State and local authorities in the enforcement of their quarantine and other health regulations, and
p.000017: shall advise the several States on matters relating to the preservation and improvement of the public health.
p.000017: (b) The Secretary shall encourage cooperative activities be- tween the States with respect to
p.000017: comprehensive and continuing planning as to their current and future health needs, the establish- ment and
p.000017: maintenance of adequate public health services, and oth- erwise carrying out the public health activities. The
p.000017: Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private
p.000017: entities reasonable fees for the training of their personnel under the preceding sentence.
p.000017: (c)(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a
p.000017: plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies
p.000017: under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or con- dition
p.000017: and to meet other health emergencies or problems. The Sec- retary may enter into agreements providing for the
p.000017: cooperative planning between the Service and public and private community health programs and agencies to cope
p.000017: with health problems (includ- ing epidemics and health emergencies).
p.000017: (2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in
p.000017: excess of six months) assistance to States or localities in meeting health emergencies of such a nature as
p.000017: to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance
p.000017: provided under this paragraph as he may determine to be reason- able under the circumstances. Any
p.000017: reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such
p.000017: reimbursement is received.
p.000017: SEC. 312. ø244¿ PUBLIC ACCESS DEFIBRILLATION PROGRAMS.
p.000017: (a) IN GENERAL.—The Secretary shall award grants to States, political subdivisions of States, Indian
p.000017: tribes, and tribal organiza- tions to develop and implement public access defibrillation pro- grams—
p.000017:
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p.000017: January 30, 2020
p.000017: (1) by training and equipping local emergency medical services personnel, including firefighters, police
p.000017: officers, para- medics, emergency medical technicians, and other first re-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: such services, to meet the health needs of the people of the State and including environmental considerations as they
p.000017: relate to public health;
p.000017: (D) provide for encouraging cooperative efforts among gov- ernmental or nongovernmental agencies, organizations
p.000017: and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such
p.000017: agencies, organiza-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000017: 95 PUBLIC HEALTH SERVICE ACT Sec. 314
p.000017:
p.000017: tions, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and
p.000017: rehabilitation;
p.000017: (E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this
p.000017: subsection will be used to supplement and, to the extent practicable, to increase the level of funds that
p.000017: would otherwise be made available by the State for the purpose of comprehensive health planning and not to
p.000017: supplant such non-Federal funds;
p.000017: (F) 7 provide such methods of administration (including methods relating to the establishment and maintenance
p.000017: of per- sonnel standards on a merit basis, except that the Secretary shall exercise no authority with respect
p.000017: to the selection, tenure of office, and compensation of any individual employed in ac- cordance with such
p.000017: methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
p.000017: (G) provide that the State agency will make such reports, in such form and containing such information, as the
p.000017: Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as
p.000017: the Secretary finds necessary to assure the correctness and verification of such re- ports;
p.000017: (H) provide that the State agency will from time to time, but not less often than annually, review its
p.000017: State plan ap- proved under this subsection and submit to the Secretary ap- propriate modifications
p.000017: thereof;
p.000017: (I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop
p.000017: a program for cap- ital expenditures for replacement, modernization, and expan- sion which is consistent
p.000017: with an overall State plan developed in accordance with criteria established by the Secretary after
p.000017: consultation with the State which will meet the needs of the State for health care facilities, equipment, and
p.000017: services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State
p.000017: agency furnishing such assistance will periodically review the program (developed pur- suant to clause (i)) of each
p.000017: health care facility in the State and recommended appropriate modification thereof;
p.000017: (J) provide for such fiscal control and fund accounting pro- cedures as may be necessary to assure proper disbursement
...

p.000101: diseases for health professionals (including allied health personnel).
p.000101: (2) The Secretary may make grants to States, political subdivi- sions of States, and other public and nonprofit private
p.000101: entities for—
p.000101: (A) research into the prevention and control of diseases and conditions;
p.000101: (B) demonstration projects for the prevention and control of such diseases and conditions;
p.000101: (C) public information and education programs for the pre- vention and control of such diseases and conditions; and
p.000101: (D) education, training, and clinical skills improvement ac- tivities in the prevention and control of such diseases
p.000101: and con-
p.000101: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000103: PUBLIC HEALTH SERVICE ACT
p.000103: Sec. 317
p.000103:
p.000103: ditions for health professionals (including allied health per- sonnel).
p.000103: (3) No grant may be made under this subsection unless an ap- plication therefor is submitted to the Secretary in
p.000103: such form, at such time, and containing such information as the Secretary may by regulation prescribe.
p.000103: (4) Subsections (d), (e), and (f) shall apply to grants under this subsection in the same manner as such subsections
p.000103: apply to grants under subsection (a).
p.000103: (l) AUTHORITY TO PURCHASE RECOMMENDED VACCINES FOR
p.000103: ADULTS.—
p.000103: (1) IN GENERAL.—The Secretary may negotiate and enter into contracts with manufacturers of vaccines for the
p.000103: purchase and delivery of vaccines for adults as provided for under sub- section (e).
p.000103: (2) STATE PURCHASE.—A State may obtain additional quan- tities of such adult vaccines (subject to amounts
p.000103: specified to the Secretary by the State in advance of negotiations) through the purchase of vaccines from
p.000103: manufacturers at the applicable price negotiated by the Secretary under this subsection.
p.000103: (m) DEMONSTRATION PROGRAM TO IMPROVE IMMUNIZATION COVERAGE.—
p.000103: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Centers for Disease Control and Prevention, shall
p.000103: es- tablish a demonstration program to award grants to States to improve the provision of recommended
p.000103: immunizations for chil- dren, adolescents, and adults through the use of evidence- based, population-based
p.000103: interventions for high-risk popu- lations.
p.000103: (2) STATE PLAN.—To be eligible for a grant under para- graph (1), a State shall submit to the Secretary an
p.000103: application at such time, in such manner, and containing such information as the Secretary may require, including
p.000103: a State plan that de- scribes the interventions to be implemented under the grant and how such
p.000103: interventions match with local needs and capa- bilities, as determined through consultation with local authori-
p.000103: ties.
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p.000103: pro- vision of immunizations, or other services;
p.000103: (F) providing reminders or recalls for immunization providers;
p.000103: (G) conducting assessments of, and providing feedback to, immunization providers;
p.000103: (H) any combination of one or more interventions de- scribed in this paragraph; or
p.000103: (I) immunization information systems to allow all States to have electronic databases for
p.000103: immunization records.
p.000103: (4) CONSIDERATION.—In awarding grants under this sub- section, the Secretary shall consider any
p.000103: reviews or rec- ommendations of the Task Force on Community Preventive Services.
p.000103: (5) EVALUATION.—Not later than 3 years after the date on which a State receives a grant under this subsection, the
p.000103: State shall submit to the Secretary an evaluation of progress made toward improving immunization coverage
p.000103: rates among high- risk populations within the State.
p.000103: (6) REPORT TO CONGRESS.—Not later than 4 years after the date of enactment of the Affordable Health Choices
p.000103: Act, the Secretary shall submit to Congress a report concerning the ef- fectiveness of the demonstration program
p.000103: established under this subsection together with recommendations on whether to continue and expand such program.
p.000103: (7) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection, such
p.000103: sums as may be necessary for each of fiscal years 2010 through 2014.
p.000103: SCREENINGS, REFERRALS, AND EDUCATION REGARDING LEAD POISONING
p.000103: SEC. 317A. ø247b–1¿ (a) AUTHORITY FOR GRANTS.—
p.000103: (1) IN GENERAL.—Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease
p.000103: Control and Prevention, may make grants to States and political sub- divisions of States for the
p.000103: initiation and expansion of commu- nity programs designed—
p.000103: (A) to provide, for infants and children—
p.000103: (i) screening for elevated blood lead levels;
p.000103: (ii) referral for treatment of such levels; and
p.000103: (iii) referral for environmental intervention associ- ated with such levels; and
p.000103: (B) to provide education about childhood lead poi- soning.
p.000103: (2) AUTHORITY REGARDING CERTAIN ENTITIES.—With re- spect to a geographic area with a need for activities
p.000103: authorized in paragraph (1), in any case in which neither the State nor the political subdivision in
p.000103: which such area is located has ap- plied for a grant under paragraph (1), the Secretary may make
p.000103: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000105: PUBLIC HEALTH SERVICE ACT
p.000105: Sec. 317A
p.000105:
p.000105:
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p.000105: January 30, 2020
p.000105: a grant under such paragraph to any grantee under section 329, 330, or 340A for carrying out such
p.000105: activities in the area.
p.000105: (3) PROVISION OF ALL SERVICES AND ACTIVITIES THROUGH EACH GRANTEE.—In making grants under paragraph (1),
p.000105: the Secretary shall ensure that each of the activities described in such paragraph is provided through
...

p.000121: (C) PRIORITY.—In allocating amounts appropriated under subparagraph (A), the Secretary shall give
p.000121: priority to allocating such amounts for grants under subsection (a).
p.000121: (D) ALLOCATION OF FUNDS.—
p.000121: (i) REQUIREMENT OF FORMULA.—Of the amounts appropriated under subparagraph (A), not reserved under
p.000121: subparagraph (B), and allocated by the Sec- retary for grants under subsection (a), the Secretary shall
p.000121: distribute a portion of such amounts to grantees under subsection (a) on the basis of a formula.
p.000121: (ii) RELEVANT FACTORS.—The formula developed by the Secretary under clause (i) shall take into ac-
p.000121: count the level of tuberculosis morbidity and case com- plexity in the respective geographic area and may con- sider
p.000121: other factors relevant to tuberculosis in such area.
p.000121: (iii) NO CHANGE TO FORMULA REQUIRED.—This subparagraph does not require the Secretary to modify the
p.000121: formula that was used by the Secretary to dis- tribute funds to grantees under subsection (a) for fis-
p.000121: cal year 2009.
p.000121: (2) LIMITATION.—The authorization of appropriations es- tablished in paragraph (1) for a fiscal year is
p.000121: effective only if the amount appropriated under such paragraph for such year equals or exceeds the amount
p.000121: appropriated to carry out this section for fiscal year 2009.
p.000121:
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p.000121: January 30, 2020
p.000121: LOAN REPAYMENT PROGRAM
p.000121: SEC. 317F. ø247b–7¿ (a) IN GENERAL.—
p.000121: (1) AUTHORITY.—Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with
p.000121: appro- priately qualified health professionals under which such health professionals agree to conduct prevention
p.000121: activities or pre- paredness and response activities, including rapid response to public health
p.000121: emergencies and significant public health threats, as employees of the Centers for Disease Control
p.000121: and Prevention and the Agency for Toxic Substances and Disease
p.000121: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000121:
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p.000123: PUBLIC HEALTH SERVICE ACT
p.000123: Sec. 317H
p.000123:
p.000123: Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than
p.000123: $50,000 of the principal and interest of the educational loans of such health professionals.
p.000123: (2) LIMITATION.—The Secretary may not enter into an agreement with a health professional pursuant to
p.000123: paragraph
p.000123: (1) unless such professional—
p.000123: (A) has a substantial amount of educational loans rel- ative to income; and
p.000123: (B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for
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p.000125:
p.000125: (2) ACTIVITIES.—For the purpose described in paragraph (1), the Secretary, acting through the Director of
p.000125: the Centers for Disease Control and Prevention, may carry out the fol- lowing activities:
p.000125: (A) The Secretary may continue and improve activities related to a national maternal mortality data collection
p.000125: and surveillance program to identify and support the re- view of pregnancy-associated deaths and
p.000125: pregnancy-related deaths that occur during, or within 1 year following, preg- nancy.
p.000125: (B) The Secretary may expand the Pregnancy Risk As- sessment Monitoring System to provide surveillance and
p.000125: collect data in each State.
p.000125: (C) The Secretary may expand the Maternal and Child Health Epidemiology Program to provide technical sup- port,
p.000125: financial assistance, or the time-limited assignment of senior epidemiologists to maternal and child health pro-
p.000125: grams in each State.
p.000125: (D) The Secretary may, in cooperation with States, In- dian tribes, and tribal organizations, develop a program to
p.000125: support States, Indian tribes, and tribal organizations in establishing or operating maternal mortality
p.000125: review com- mittees, in accordance with subsection (d).
p.000125: (b) PREVENTION RESEARCH.—
p.000125: (1) PURPOSE.—The purpose of this subsection is to provide the Secretary with the authority to further expand
p.000125: research concerning risk factors, prevention strategies, and the roles of the family, health care providers
p.000125: and the community in safe motherhood.
p.000125: (2) RESEARCH.—The Secretary may carry out activities to expand research relating to—
p.000125: (A) prepregnancy counseling, especially for at risk pop- ulations such as women with diabetes and women with
p.000125: substance use disorder;
p.000125: (B) the identification of critical components of prenatal delivery and postpartum care;
p.000125: (C) the identification of outreach and support services, such as folic acid education, that are available for
p.000125: preg- nant women;
p.000125: (D) the identification of women who are at high risk for complications;
p.000125: (E) preventing preterm delivery;
p.000125: (F) preventing urinary tract infections;
p.000125: (G) preventing unnecessary caesarean sections;
p.000125: (H) the identification of the determinants of disparities in maternal care, health risks, and health outcomes,
p.000125: in- cluding an examination of the higher rates of maternal mortality among African American women and
...

p.000135: Secretary.
p.000135: (5) To improve the education, training, and skills of health professionals in the detection and control of
p.000135: infections de- scribed in paragraph (1), including to improve coordination of treatment of substance use
p.000135: disorders and infectious diseases, with priority given to substance use disorder treatment pro- viders,
p.000135: pediatricians and other primary care providers, obste- trician-gynecologists, and infectious disease
p.000135: clinicians, includ- ing HIV clinicians.
p.000135: (b) LABORATORY PROCEDURES.—The Secretary may (directly or through grants to public and nonprofit private
p.000135: entities) carry out programs to provide for improvements in the quality of clinical-lab- oratory procedures
p.000135: regarding infections described in subsection (a)(1).
p.000135: (c) DEFINITION.—In this section, the term ‘‘Indian tribe’’ has the meaning given that term in section 4 of the
p.000135: Indian Self-Deter- mination and Education Assistance Act.
p.000135: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000135: to be appropriated
p.000135: $40,000,000 for each of the fiscal years 2019 through 2023.
p.000135:
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p.000135: January 30, 2020
p.000135:
p.000135: GRANTS FOR LEAD POISONING RELATED ACTIVITIES
p.000135: SEC. 317O. ø247b–16¿ (a) AUTHORITY TO MAKE GRANTS.—
p.000135: (1) IN GENERAL.—The Secretary shall make grants to States to support public health activities in
p.000135: States and local- ities where data suggests that at least 5 percent of preschool- age children have an
p.000135: elevated blood lead level through—
p.000135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000135: Sec. 317O PUBLIC HEALTH SERVICE ACT 136
p.000135:
p.000135: (A) effective, ongoing outreach and community edu- cation targeted to families most likely to be at risk for lead
p.000135: poisoning;
p.000135: (B) individual family education activities that are de- signed to reduce ongoing exposures to lead for
p.000135: children with elevated blood lead levels, including through home visits and coordination with other
p.000135: programs designed to identify and treat children at risk for lead poisoning; and
p.000135: (C) the development, coordination and implementation of community-based approaches for comprehensive lead
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p.000147: PUBLIC HEALTH SERVICE ACT
p.000147: Sec. 318
p.000147:
p.000147: PROJECTS AND PROGRAMS FOR THE PREVENTION AND CONTROL OF SEXUALLY TRANSMITTED DISEASES 16
p.000147: SEC. 318. ø247c¿ (a) The Secretary may provide technical as- sistance to appropriate public and non-profit
p.000147: private entities and to scientific institutions for their research in, and training and public health programs for
p.000147: the prevention and control of sexually trans- mitted diseases.
p.000147: (b) The Secretary may make grants to States, political subdivi- sions of States, and any other public and
p.000147: nonprofit private entity for—
p.000147: (1) research into the prevention and control of sexually transmitted diseases;
p.000147: (2) demonstration projects for the prevention and control of sexually transmitted diseases;
p.000147: (3) public information and education programs for the pre- vention and control of such diseases; and
p.000147: (4) education, training, and clinical skills improvement ac- tivities in the prevention and control of such
p.000147: diseases for health professionals (including allied health personnel).
p.000147: (c) The Secretary is also authorized to make project grants to States and, in consultation with the
p.000147: State health authority, to po- litical subdivisions of States, for—
p.000147: (1) sexually transmitted diseases surveillance activities, in- cluding the reporting, screening, and followup of
p.000147: diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
p.000147: (2) casefinding and case followup activities respecting sex- ually transmitted diseases, including contact tracing
p.000147: of infec- tious cases of sexually transmitted diseases and routine test- ing, including laboratory tests and
p.000147: followup systems;
p.000147: (3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
p.000147: (4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and
p.000147: control strat- egies and activities as may be prescribed by the Secretary.
p.000147: (d) The Secretary may make grants to States and political sub- divisions of States for the development,
p.000147: implementation, and eval- uation of innovative, interdisciplinary approaches to the prevention and control of
p.000147: sexually transmitted diseases.
p.000147: (e)(1) For the purpose of making grants under subsections (b) through (d), there are authorized to be
p.000147: appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal
p.000147: years 1995 through 1998.
p.000147: (2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe
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p.000147: State or political subdivision of a State. Information derived from any such program may be disclosed—
p.000147: (A) in summary, statistical, or other form; or
p.000147: (B) for clinical or research purposes;
p.000147: but only if the identity of the individuals diagnosed or provided care or treatment under such program is not
p.000147: disclosed.
p.000147: (f) Nothing in this section shall be construed to require any State or any political subdivision of a
p.000147: State to have a sexually transmitted diseases program which would require any person, who objects to any
p.000147: treatment provided under such a program, to be treated under such a program.
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p.000147: January 30, 2020
p.000147: INFERTILITY AND SEXUALLY TRANSMITTED DISEASES
p.000147:
p.000147: SEC. 318A. ø247c–1¿ (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease
p.000147: Control and Pre- vention, may make grants to States, political subdivisions of States, and other
p.000147: public or nonprofit private entities for the pur- pose of carrying out the activities described in
p.000147: subsection (c) re- garding any treatable sexually transmitted disease that can cause infertility in women if
p.000147: treatment is not received for the disease.
p.000147: (b) AUTHORITY REGARDING INDIVIDUAL DISEASES.—With re- spect to diseases described in subsection (a), the
p.000147: Secretary shall, in making a grant under such subsection, specify the particular dis- ease or diseases with
p.000147: respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved
p.000147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000149: PUBLIC HEALTH SERVICE ACT
p.000149: Sec. 318A
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p.000149: agrees to carry out this section only with respect to the disease or diseases so specified.
p.000149: (c) AUTHORIZED ACTIVITIES.—With respect to any sexually transmitted disease described in subsection
p.000149: (a), the activities re- ferred to in such subsection are—
p.000149: (1) screening women for the disease and for secondary con- ditions resulting from the disease, subject to
p.000149: compliance with criteria issued under subsection (f);
p.000149: (2) providing treatment to women for the disease;
p.000149: (3) providing counseling to women on the prevention and control of the disease (including, in the case
p.000149: of a woman with the disease, counseling on the benefits of locating and pro- viding such counseling
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p.000155: and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly
p.000155: after granting such an extension or waiver, the Sec- retary shall notify the Congress of such action
p.000155: and publish in the Federal Register a notice of the extension or waiver.
p.000155: (e) TEMPORARY REASSIGNMENT OF STATE AND LOCAL PER-
p.000155: SONNEL DURING A PUBLIC HEALTH EMERGENCY.—
p.000155: (1) EMERGENCY REASSIGNMENT OF FEDERALLY FUNDED PER- SONNEL.—Notwithstanding any other provision of law,
p.000155: and subject to paragraph (2), upon request by the Governor of a State or a tribal organization or such
p.000155: Governor or tribal orga- nization’s designee, the Secretary may authorize the requesting State or Indian tribe to
p.000155: temporarily reassign, for purposes of immediately addressing a public health emergency in the State or Indian
p.000155: tribe, State and local public health department or agency personnel funded in whole or in part through programs
p.000155: authorized under this Act, as appropriate.
p.000155: (2) ACTIVATION OF EMERGENCY REASSIGNMENT.—
p.000155: (A) PUBLIC HEALTH EMERGENCY.—The Secretary may authorize a temporary reassignment of personnel under
p.000155: paragraph (1) only during the period of a public health emergency determined pursuant to subsection (a).
p.000155: (B) CONTENTS OF REQUEST.—To seek authority for a temporary reassignment of personnel under paragraph (1), the
p.000155: Governor of a State or a tribal organization shall sub- mit to the Secretary a request for such reassignment flexi-
p.000155: bility and shall include in the request each of the fol- lowing:
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p.000155: January 30, 2020
p.000155: (i) An assurance that the public health emergency in the geographic area of the requesting State or In-
p.000155: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000155: Sec. 319 PUBLIC HEALTH SERVICE ACT 156
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p.000155: dian tribe cannot be adequately and appropriately ad- dressed by the public health workforce otherwise
p.000155: available.
p.000155: (ii) An assurance that the public health emergency would be addressed more efficiently and effectively through
p.000155: the requested temporary reassignment of State and local personnel described in paragraph (1).
p.000155: (iii) An assurance that the requested temporary reassignment of personnel is consistent with any ap-
p.000155: plicable All-Hazards Public Health Emergency Pre- paredness and Response Plan under section 319C–1.
p.000155: (iv) An identification of—
p.000155: (I) each Federal program from which per- sonnel would be temporarily reassigned pursuant to the
p.000155: requested authority; and
p.000155: (II) the number of personnel who would be so reassigned from each such program.
p.000155: (v) Such other information and assurances upon which the Secretary and Governor of a State or tribal organization
p.000155: agree.
p.000155: (C) CONSIDERATION.—In reviewing a request for tem- porary reassignment under paragraph (1), the Secretary
p.000155: shall consider the degree to which the program or pro- grams funded in whole or in part by programs
p.000155: authorized under this Act would be adversely affected by the reassign- ment.
p.000155: (D) TERMINATION AND EXTENSION.—
p.000155: (i) TERMINATION.—A State or Indian tribe’s tem- porary reassignment of personnel under paragraph (1) shall
p.000155: terminate upon the earlier of the following:
p.000155: (I) The Secretary’s determination that the public health emergency no longer exists.
p.000155: (II) Subject to clause (ii), the expiration of the 30-day period following the date on which the Sec- retary approved
p.000155: the State or Indian tribe’s request for such reassignment flexibility.
p.000155: (ii) EXTENSION OF REASSIGNMENT FLEXIBILITY.— The Secretary may extend reassignment flexibility of
p.000155: personnel under paragraph (1) beyond the date other- wise applicable under clause (i)(II) if the public health
p.000155: emergency still exists as of such date, but only if—
p.000155: (I) the State or Indian tribe that submitted the initial request for a temporary reassignment of personnel
p.000155: submits a request for an extension of such temporary reassignment; and
p.000155: (II) the request for an extension contains the same information and assurances necessary for the approval
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p.000163: PUBLIC HEALTH SERVICE ACT
p.000163: Sec. 319C–1
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p.000163: relative distribution of amounts received under this sec- tion.
p.000163: (c) LIMITATION.—Beginning in fiscal year 2009, the Secretary may not award a cooperative agreement to a
p.000163: State unless such State is a participant in the Emergency System for Advance Reg- istration of Volunteer
p.000163: Health Professionals described in section 319I.
p.000163: (d) USE OF FUNDS.—
p.000163: (1) IN GENERAL.—An award under subsection (a) shall be expended for activities to achieve the
p.000163: preparedness goals de- scribed under paragraphs (1), (2), (4), (5), and (6) of section 2802(b).
p.000163: (2) EFFECT OF SECTION.—Nothing in this subsection may be construed as establishing new regulatory
p.000163: authority or as modifying any existing regulatory authority.
p.000163: (e) COORDINATION WITH LOCAL RESPONSE CAPABILITIES.—An entity shall, to the extent practicable, ensure that
p.000163: activities carried out under an award under subsection (a) are coordinated with ac- tivities of relevant
p.000163: Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative,
p.000163: local emergency plans, and any regional health care emergency pre- paredness and response system
p.000163: established pursuant to the appli- cable guidelines under section 319C–3.
p.000163: (f) CONSULTATION WITH HOMELAND SECURITY.—In making awards under subsection (a), the Secretary shall
p.000163: consult with the Secretary of Homeland Security to—
p.000163: (1) ensure maximum coordination of public health and medical preparedness and response activities with the
p.000163: Metro- politan Medical Response System, and other relevant activities;
p.000163: (2) minimize duplicative funding of programs and activi- ties; and
p.000163: (3) analyze activities, including exercises and drills, con- ducted under this section to develop
p.000163: recommendations and guidance on best practices for such activities.
p.000163: (g) ACHIEVEMENT OF MEASURABLE EVIDENCE-BASED BENCH-
p.000163: MARKS AND OBJECTIVE STANDARDS.—
p.000163: (1) IN GENERAL.—Not later than 180 days after the date of enactment of the Pandemic and All-Hazards Preparedness Act,
p.000163: the Secretary shall develop or where appropriate adopt, and re- quire the application of, measurable
p.000163: evidence-based bench- marks and objective standards that measure levels of pre- paredness with respect to
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p.000165: an entity experienced such a failure, in lieu of applying clause (i), an amount equal to 15 percent of
p.000165: the amount the entity was eligible to receive for the respective fiscal year.
p.000165: (B) SEPARATE ACCOUNTING.—Each failure described in subparagraph (A) or (B) of paragraph (5) shall be treated
p.000165: as a separate failure for purposes of calculating amounts withheld under subparagraph (A).
p.000165: (7) REALLOCATION OF AMOUNTS WITHHELD.—
p.000165: (A) IN GENERAL.—The Secretary shall make amounts withheld under paragraph (6) available for making awards under
p.000165: section 319C–2 to entities described in subsection (b)(1) of such section.
p.000165: (B) PREFERENCE IN REALLOCATION.—In making awards under section 319C–2 with amounts described in subpara- graph (A),
p.000165: the Secretary shall give preference to eligible entities (as described in section 319C–2(b)(1)) that are
p.000165: lo- cated in whole or in part in States from which amounts have been withheld under paragraph (6).
p.000165: (8) WAIVE OR REDUCE WITHHOLDING.—The Secretary may waive or reduce the withholding described in paragraph (6),
p.000165: for a single entity or for all entities in a fiscal year, if the Sec- retary determines that mitigating
p.000165: conditions exist that justify the waiver or reduction.
p.000165: (h) FUNDING.—
p.000165: (1) AUTHORIZATION OF APPROPRIATIONS.—
p.000165: (A) IN GENERAL.—For the purpose of carrying out this section, there is authorized to be
p.000165: appropriated
p.000165: $685,000,000 for each of fiscal years 2019 through 2023 for awards pursuant to paragraph (3) (subject to the authority
p.000165: of the Secretary to make awards pursuant to paragraphs (4) and (5)).
p.000165: (B) REQUIREMENT FOR STATE MATCHING FUNDS.—Be- ginning in fiscal year 2009, in the case of any State or con-
p.000165: sortium of two or more States, the Secretary may not award a cooperative agreement under this section
p.000165: unless the State or consortium of States agree that, with respect to the amount of the cooperative
p.000165: agreement awarded by the Secretary, the State or consortium of States will make available (directly or through
p.000165: donations from public or pri- vate entities) non-Federal contributions in an amount equal to—
p.000165: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000165: Sec. 319C–1 PUBLIC HEALTH SERVICE ACT 166
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p.000173: (1) IN GENERAL.—
p.000173: (A) AUTHORIZATION OF APPROPRIATIONS.—For purposes of carrying out this section and section 319C–3, in accord- ance
p.000173: with subparagraph (B), there is authorized to be ap- propriated $385,000,000 for each of fiscal
p.000173: years 2019 through 2023.
p.000173: (B) RESERVATION OF AMOUNTS FOR REGIONAL SYS- TEMS.—
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p.000173: (i) IN GENERAL.—Subject to clause (ii), of the amount appropriated under subparagraph (A) for a fis- cal
p.000173: year, the Secretary may reserve up to 5 percent for the purpose of carrying out section 319C–3.
p.000173: (ii) RESERVATION CONTINGENT ON CONTINUED AP- PROPRIATIONS FOR THIS SECTION.—If for fiscal year 2019 or
p.000173: a subsequent fiscal year, the amount appro- priated under subparagraph (A) is such that, after ap- plication of
p.000173: clause (i), the amount remaining for the purpose of carrying out this section would be less than the amount
p.000173: available for such purpose for the previous fiscal year, the amount that may be reserved under clause (i)
p.000173: shall be reduced such that the amount re- maining for the purpose of carrying out this section is not less
p.000173: than the amount available for such purpose for the previous fiscal year.
p.000173: (iii) SUNSET.—The authority to reserve amounts under clause (i) shall expire on September 30, 2023.
p.000173: (2) RESERVATION OF AMOUNTS FOR PARTNERSHIPS.—Prior to making awards described in paragraph (3), the
p.000173: Secretary may reserve from the amount appropriated under paragraph (1)(A) for a fiscal year and not reserved
p.000173: for the purpose described in paragraph (1)(B)(i), an amount determined appropriate by the Secretary for making
p.000173: awards to entities described in subsection (b)(1)(A).
p.000173: (3) AWARDS TO STATES AND POLITICAL SUBDIVISIONS.—
p.000173: (A) IN GENERAL.—From amounts appropriated for a fiscal year under paragraph (1)(A) and not reserved under
p.000173: paragraph (1)(B)(i) or (2), the Secretary shall make awards to entities described in subsection (b)(2)(A) that have
p.000173: com- pleted an application as described in subsection (b)(2)(B).
p.000173: (B) AMOUNT.—The Secretary shall determine the amount of an award to each entity described in
p.000173: subpara- graph (A) in the same manner as such amounts are deter- mined under section 319C–1(h).
p.000173: (4) AVAILABILITY OF COOPERATIVE AGREEMENT FUNDS.—
p.000173: (A) IN GENERAL.—Amounts provided to an eligible en- tity under a cooperative agreement under subsection (a) for
p.000173: a fiscal year and remaining unobligated at the end of such year shall remain available to such entity
p.000173: for the next fiscal year for the purposes for which such funds were provided.
p.000173: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000175: January 30, 2020
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p.000175: (d) TECHNICAL ASSISTANCE.—The Assistant Secretary for Pre- paredness and Response, in consultation with the
p.000175: Director of the Centers for Disease Control and Prevention and the Assistant Sec- retary of Labor for
p.000175: Occupational Safety and Health, may provide technical assistance and consultation toward meeting the guide-
p.000175: lines described in subsection (b).
p.000175: (e) DEMONSTRATION PROJECT FOR REGIONAL HEALTH CARE PREPAREDNESS AND RESPONSE SYSTEMS.—
p.000175: (1) IN GENERAL.—The Assistant Secretary for Prepared- ness and Response may establish a demonstration project
p.000175: pur- suant to the development and implementation of guidelines under subsection (b) to award grants to improve
p.000175: medical surge capacity for all hazards, build and integrate regional medical response capabilities, improve
p.000175: specialty care expertise for all- hazards response, and coordinate medical preparedness and re- sponse across
p.000175: State, local, Tribal, territorial, and regional juris- dictions.
p.000175: (2) SUNSET.—The authority under this subsection shall ex- pire on September 30, 2023.
p.000175: SEC. 319D. ø247d–4¿ FACILITIES AND CAPACITIES OF THE CENTERS FOR DISEASE CONTROL AND PREVENTION.
p.000175: (a) IN GENERAL.—
p.000175: (1) FINDINGS.—Congress finds that the Centers for Disease Control and Prevention has an essential role in
p.000175: defending against and combatting public health threats domestically and abroad and requires secure and modern
p.000175: facilities, and ex- panded, improved, and appropriately maintained capabilities related to bioterrorism and
p.000175: other public health emergencies, sufficient to enable such Centers to conduct this important mission.
p.000175: (2) FACILITIES.—
p.000175: (A) IN GENERAL.—The Director of the Centers for Dis- ease Control and Prevention may design, construct, and
p.000175: equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings,
p.000175: scientific com- munication facilities, transshipment complexes, secured and isolated parking structures,
p.000175: office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to
p.000175: better conduct the capacities de- scribed in section 319A, and for supporting public health activities.
p.000175: (B) MULTIYEAR CONTRACTING AUTHORITY.—For any project of designing, constructing, equipping, or renovating any
p.000175: facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into
p.000175: a single contract or related contracts that collectively in- clude the full scope of the project, and the
p.000175: solicitation and contract shall contain the clause ‘‘availability of funds’’ found at section 52.232–18 of title
p.000175: 48, Code of Federal Reg- ulations.
p.000175: (3) IMPROVING THE CAPACITIES OF THE CENTERS FOR DIS- EASE CONTROL AND PREVENTION.—The Secretary shall
p.000175: expand, improve, enhance, and appropriately maintain the capabilities of the Centers for Disease Control
p.000175: and Prevention relating to
p.000175: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000177: PUBLIC HEALTH SERVICE ACT
p.000177: Sec. 319D
p.000177:
p.000177: preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be
p.000177: carried out under the preceding sentence include—
p.000177: (A) expanding or enhancing the training of personnel;
p.000177: (B) improving communications facilities and networks, including delivery of necessary information to rural areas;
p.000177: (C) improving capabilities for public health surveil- lance and reporting activities, taking into account the
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p.000181:
p.000181: (iii) the identification of gaps and inefficiencies in nationwide public health situational awareness and
p.000181: biosurveillance capabilities, resources, and authorities needed to address such gaps; and
p.000181: (iv) a strategy to minimize and address such gaps and improve inefficiencies.
p.000181: (7) CONSULTATION WITH THE NATIONAL BIODEFENSE SCIENCE BOARD.—In carrying out this section and
p.000181: consistent with section 319M, the National Biodefense Science Board shall provide expert advice and
p.000181: guidance, including rec- ommendations, regarding the measurable steps the Secretary should take to
p.000181: modernize and enhance biosurveillance activi- ties pursuant to the efforts of the Department of Health
p.000181: and Human Services to ensure comprehensive, real-time, all-haz- ards biosurveillance capabilities. In
p.000181: complying with the pre- ceding sentence, the National Biodefense Science Board shall—
p.000181: (A) identify the steps necessary to achieve a national biosurveillance system for human health (taking
p.000181: into ac- count zoonotic disease, including gaps in scientific under- standing of the interactions between
p.000181: human, animal, and environmental health), with international connectivity, where appropriate, that is
p.000181: predicated on State, regional, and community level capabilities and creates a networked system to allow for
p.000181: two-way information flow between and among Federal, State, and local government public health authorities and
p.000181: clinical health care providers;
p.000181: (B) identify any duplicative surveillance programs and gaps in surveillance programs under the authority of the
p.000181: Secretary, or changes that are necessary to existing pro- grams, in order to enhance and modernize such
p.000181: activities, minimize duplication, strengthen and streamline such ac- tivities under the authority of the
p.000181: Secretary, and achieve real-time and appropriate data that relate to disease activ- ity, both human and zoonotic;
p.000181: (C) coordinate with applicable existing advisory com- mittees of the Director of the Centers for Disease
p.000181: Control and Prevention, including such advisory committees con- sisting of representatives from State, local, and
p.000181: tribal pub- lic health authorities and appropriate public and private sector health care entities, animal health
p.000181: organizations re- lated to zoonotic disease, and academic institutions, in order to provide guidance on public
p.000181: health surveillance ac- tivities; and
p.000181: (D) provide recommendations to the Secretary on poli- cies and procedures to complete the steps described in this
p.000181: paragraph in a manner that is consistent with section 2802.
p.000181: (8) SITUATIONAL AWARENESS AND BIOSURVEILLANCE AS A NATIONAL SECURITY PRIORITY.—The Secretary, on a
p.000181: periodic basis as applicable and appropriate, shall meet with the Direc- tor of National Intelligence to inform the
p.000181: development and ca- pabilities of the nationwide public health situational awareness and biosurveillance network.
p.000181: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000183: PUBLIC HEALTH SERVICE ACT
p.000183: Sec. 319D
p.000183:
p.000183: (d) STATE AND REGIONAL SYSTEMS TO ENHANCE SITUATIONAL AWARENESS IN PUBLIC HEALTH EMERGENCIES.—
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p.000193: (B) a priority to treat, identify, or prevent conditions that may result in adverse health consequences
p.000193: or death
p.000193: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000195: PUBLIC HEALTH SERVICE ACT
p.000195: Sec. 319F–1
p.000195:
p.000195: and may be caused by the administering of a drug, biologi- cal product, device, vaccine, vaccine adjuvant, antiviral,
p.000195: or diagnostic test that is a priority under subparagraph (A).
p.000195: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000195: (1) FISCAL YEAR 2007.—There are authorized to be appro- priated to carry out this section for fiscal year 2007—
p.000195: (A) to carry out subsection (a)—
p.000195: (i) $5,000,000 to carry out paragraphs (1) through (4); and
p.000195: (ii) $7,000,000 to carry out paragraph (5);
p.000195: (B) to carry out subsection (c), $3,000,000; and
p.000195: (C) to carry out subsection (d), $31,000,000, of which
p.000195: $5,000,000 shall be used to carry out paragraphs (3) through (5) of such subsection.
p.000195: (2) SUBSEQUENT FISCAL YEARS.—There are authorized to be appropriated such sums as may be necessary to carry out this
p.000195: section for fiscal year 2008 and each subsequent fiscal year.
p.000195: SEC. 319F–1. ø247d–6a¿ AUTHORITY FOR USE OF CERTAIN PROCE- DURES REGARDING QUALIFIED COUNTERMEASURE
p.000195: RE- SEARCH AND DEVELOPMENT ACTIVITIES. 21
p.000195: (a) IN GENERAL.—
p.000195: (1) AUTHORITY.—In conducting and supporting research and development activities regarding countermeasures
p.000195: under section 319F(e), the Secretary may conduct and support such activities in accordance with this
p.000195: section and, in consultation with the Director of the National Institutes of Health, as part of the program under
p.000195: section 446, if the activities concern qualified countermeasures.
p.000195: (2) DEFINITIONS.—In this section:
p.000195: (A) QUALIFIED COUNTERMEASURE.—The term ‘‘quali- fied countermeasure’’ means a drug (as that term is de-
p.000195: fined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological
p.000195: product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is
p.000195: defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the
p.000195: Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of the Home- land
p.000195: Security Act of 2002)—
p.000195: (i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that
p.000195: cause an infectious disease) or toxin, chemical, radio- logical, or nuclear agent that may cause a
p.000195: public health emergency affecting national security;
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p.000195:
p.000195: (iii) is a product or technology intended to en- hance the use or effect of a drug, biological product, or
p.000195: device described in clause (i) or (ii).
p.000195: (B) INFECTIOUS DISEASE.—The term ‘‘infectious dis- ease’’ means a disease potentially caused by a
p.000195: pathogenic organism (including a bacteria, virus, fungus, or parasite) that is acquired by a person and
p.000195: that reproduces in that person.
p.000195: (3) INTERAGENCY COOPERATION.—
p.000195: (A) IN GENERAL.—In carrying out activities under this section, the Secretary is authorized, subject to subpara-
p.000195: graph (B), to enter into interagency agreements and other collaborative undertakings with other agencies of
p.000195: the United States Government.
p.000195: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000195: the authorities provided by this section.
p.000195: (4) AVAILABILITY OF FACILITIES TO THE SECRETARY.—In any grant, contract, or cooperative agreement entered
p.000195: into under the authority provided in this section with respect to a bio- containment laboratory or other
p.000195: related or ancillary specialized research facility that the Secretary determines necessary for the purpose of
p.000195: performing, administering, or supporting quali- fied countermeasure research and development, the Secretary
p.000195: may provide that the facility that is the object of such grant, contract, or cooperative agreement shall be
p.000195: available as needed to the Secretary to respond to public health emergencies affect- ing national security.
p.000195: (5) TRANSFERS OF QUALIFIED COUNTERMEASURES.—Each agreement for an award of a grant, contract, or
p.000195: cooperative agreement under section 319F(e) for the development of a qualified countermeasure shall provide
p.000195: that the recipient of the award will comply with all applicable export-related controls with respect to such
p.000195: countermeasure.
p.000195: (b) EXPEDITED PROCUREMENT AUTHORITY.—
p.000195: (1) INCREASED SIMPLIFIED ACQUISITION THRESHOLD FOR QUALIFIED COUNTERMEASURE PROCUREMENTS.—
p.000195: (A) IN GENERAL.—For any procurement by the Sec- retary of property or services for use (as determined by the
p.000195: Secretary) in performing, administering, or supporting qualified countermeasure research or development
p.000195: activi- ties under this section that the Secretary determines nec- essary to respond to pressing research
p.000195: and development needs under this section, the amount specified in section 4(11) of the Office of Federal
p.000195: Procurement Policy Act (41
p.000195: U.S.C. 403(11)), as applicable pursuant to section 302A(a) of the Federal Property and Administrative Services
p.000195: Act of 1949 (41 U.S.C. 252a(a)), shall be deemed to be
p.000195: $25,000,000 in the administration, with respect to such procurement, of—
p.000195: (i) section 303(g)(1)(A) of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000195: 253(g)(1)(A)) and its implementing regulations; and
p.000195: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000197: PUBLIC HEALTH SERVICE ACT
p.000197: Sec. 319F–1
p.000197:
p.000197: (ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) and its implementing regulations.
p.000197: (B) APPLICATION OF CERTAIN PROVISIONS.—Notwith- standing subparagraph (A) and the provision of law and
p.000197: regulations referred to in such subparagraph, each of the following provisions shall apply to procurements
p.000197: described in this paragraph to the same extent that such provisions would apply to such procurements in the
p.000197: absence of sub- paragraph (A):
p.000197: (i) Chapter 37 of title 40, United States Code (re- lating to contract work hours and safety standards).
p.000197: (ii) Subsections (a) and (b) of section 7 of the Anti- Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
p.000197: (iii) Section 304C of the Federal Property and Ad- ministrative Services Act of 1949 (41 U.S.C. 254d) (re- lating to
p.000197: the examination of contractor records).
p.000197: (iv) Section 3131 of title 40, United States Code (relating to bonds of contractors of public buildings or
p.000197: works).
p.000197: (v) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41
p.000197: U.S.C. 254(a)) (relating to contingent fees to middle- men).
p.000197: (vi) Section 6002 of the Solid Waste Disposal Act (42 U.S.C. 6962).
p.000197: (vii) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000197: appropriated funds for contracts with entities not meeting veterans employment reporting requirements).
p.000197: (C) INTERNAL CONTROLS TO BE INSTITUTED.—The Sec- retary shall institute appropriate internal controls for pro-
p.000197: curements that are under this paragraph, including re- quirements with regard to documenting the
p.000197: justification for use of the authority in this paragraph with respect to the procurement involved.
p.000197: (D) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this paragraph, the Secretary may not
p.000197: use the authority provided for under subparagraph (A) to conduct a procurement on a basis other than full and
p.000197: open competition unless the Secretary determines that the mission of the BioShield Program under the Project
p.000197: Bio- Shield Act of 2004 would be seriously impaired without such a limitation.
p.000197: (2) PROCEDURES OTHER THAN FULL AND OPEN COMPETI- TION.—
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p.000197: January 30, 2020
p.000197: (A) IN GENERAL.—In using the authority provided in section 303(c)(1) of title III of the Federal Property and
p.000197: Ad- ministrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive
p.000197: procedures in the case of a procurement described in paragraph (1) of this subsection, the phrase
p.000197: ‘‘available from only one responsible source’’ in such section 303(c)(1) shall be deemed to mean ‘‘available
p.000197: from only one responsible source or only from a limited number of responsible sources’’.
p.000197: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000197:
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p.000197: Sec. 319F–1 PUBLIC HEALTH SERVICE ACT 198
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p.000197: (B) RELATION TO OTHER AUTHORITIES.—The authority under subparagraph (A) is in addition to any other author- ity to
p.000197: use procedures other than competitive procedures.
p.000197: (C) APPLICABLE GOVERNMENT-WIDE REGULATIONS.— The Secretary shall implement this paragraph in accord-
p.000197: ance with government-wide regulations implementing such section 303(c)(1) (including requirements that offers be so-
p.000197: licited from as many potential sources as is practicable under the circumstances, that required notices
p.000197: be pub- lished, and that submitted offers be considered), as such regulations apply to procurements for which
p.000197: an agency has authority to use procedures other than competitive proce- dures when the property or services
p.000197: needed by the agency are available from only one responsible source or only from a limited number of responsible
p.000197: sources and no other type of property or services will satisfy the needs of the agency.
p.000197: (3) INCREASED MICROPURCHASE THRESHOLD.—
p.000197: (A) IN GENERAL.—For a procurement described by paragraph (1), the amount specified in subsections (c), (d),
p.000197: and (f) of section 32 of the Office of Federal Procurement Policy Act (41 U.S.C. 428) shall be deemed
p.000197: to be $15,000 in the administration of that section with respect to such procurement.
p.000197: (B) INTERNAL CONTROLS TO BE INSTITUTED.—The Sec- retary shall institute appropriate internal controls for pur-
p.000197: chases that are under this paragraph and that are greater than $2,500.
p.000197: (C) EXCEPTION TO PREFERENCE FOR PURCHASE CARD MECHANISM.—No provision of law establishing a preference for
p.000197: using a Government purchase card method for pur- chases shall apply to purchases that are under this
p.000197: para- graph and that are greater than $2,500.
p.000197: (4) REVIEW.—
p.000197: (A) REVIEW ALLOWED.—Notwithstanding subsection (f), section 1491 of title 28, United States Code, and section
p.000197: 3556 of title 31 of such Code, review of a contracting agen- cy decision relating to a procurement described in
p.000197: para- graph (1) may be had only by filing a protest—
p.000197: (i) with a contracting agency; or
p.000197: (ii) with the Comptroller General under sub- chapter V of chapter 35 of title 31, United States
p.000197: Code.
p.000197: (B) OVERRIDE OF STAY OF CONTRACT AWARD OR PER- FORMANCE COMMITTED TO AGENCY DISCRETION.—Notwith-
p.000197: standing section 1491 of title 28, United States Code, and section 3553 of title 31 of such Code, the following author-
p.000197: izations by the head of a procuring activity are committed to agency discretion:
p.000197: (i) An authorization under section 3553(c)(2) of title 31, United States Code, to award a contract for a
p.000197: procurement described in paragraph (1) of this sub- section.
p.000197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000199: PUBLIC HEALTH SERVICE ACT
p.000199: Sec. 319F–1
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p.000199: (ii) An authorization under section 3553(d)(3)(C) of such title to perform a contract for a procurement de- scribed in
p.000199: paragraph (1) of this subsection.
p.000199: (c) AUTHORITY TO EXPEDITE PEER REVIEW.—
p.000199: (1) IN GENERAL.—The Secretary may, as the Secretary de- termines necessary to respond to pressing qualified
p.000199: counter- measure research and development needs under this section, employ such expedited peer review
p.000199: procedures (including con- sultation with appropriate scientific experts) as the Secretary, in consultation
p.000199: with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely
p.000199: contribution to the field of qualified countermeasure research, in place of the peer review and advisory
p.000199: council review proce- dures that would be required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2),
p.000199: 406(a)(3)(A), 492, and 494, as applicable to a grant, contract, or cooperative agreement—
p.000199: (A) that is for performing, administering, or sup- porting qualified countermeasure research and
p.000199: develop- ment activities; and
p.000199: (B) the amount of which is not greater than
p.000199: $1,500,000.
p.000199: (2) SUBSEQUENT PHASES OF RESEARCH.—The Secretary’s determination of whether to employ expedited peer review
p.000199: with respect to any subsequent phases of a research grant, contract, or cooperative agreement under this section
p.000199: shall be deter- mined without regard to the peer review procedures used for any prior peer review of that
p.000199: same grant, contract, or coopera- tive agreement. Nothing in the preceding sentence may be con- strued to impose any
p.000199: requirement with respect to peer review not otherwise required under any other law or regulation.
p.000199: (d) AUTHORITY FOR PERSONAL SERVICES CONTRACTS.—
p.000199: (1) IN GENERAL.—For the purpose of performing, admin- istering, or supporting qualified countermeasure
p.000199: research and development activities, the Secretary may, as the Secretary de- termines necessary to respond to
p.000199: pressing qualified counter- measure research and development needs under this section, obtain by contract
p.000199: (in accordance with section 3109 of title 5, United States Code, but without regard to the limitations
p.000199: in such section on the period of service and on pay) the personal services of experts or consultants who have
p.000199: scientific or other professional qualifications, except that in no case shall the compensation provided to
p.000199: any such expert or consultant exceed the daily equivalent of the annual rate of compensation for the President.
p.000199: (2) FEDERAL TORT CLAIMS ACT COVERAGE.—
p.000199: (A) IN GENERAL.—A person carrying out a contract under paragraph (1), and an officer, employee, or gov-
p.000199: erning board member of such person, shall, subject to a de- termination by the Secretary, be deemed to be an
p.000199: em- ployee of the Department of Health and Human Services for purposes of claims under sections 1346(b)
p.000199: and 2672 of title 28, United States Code, for money damages for per- sonal injury, including death,
p.000199: resulting from performance of functions under such contract.
p.000199: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000199: such entity under a contract with the United States or from any grossly negligent or reckless conduct
p.000199: or intentional or willful misconduct on the part of such entity.
p.000199: (ii) VENUE.—The United States may maintain an action under this subparagraph against such entity in the district
p.000199: court of the United States in which such entity resides or has its principal place of business.
p.000199: (3) INTERNAL CONTROLS TO BE INSTITUTED.—
p.000199: (A) IN GENERAL.—The Secretary shall institute appro- priate internal controls for contracts under this
p.000199: subsection, including procedures for the Secretary to make a deter- mination of whether a person, or an
p.000199: officer, employee, or governing board member of a person, is deemed to be an employee of the Department
p.000199: of Health and Human Serv- ices pursuant to paragraph (2).
p.000199: (B) DETERMINATION OF EMPLOYEE STATUS TO BE FINAL.—A determination by the Secretary under
p.000199: subpara- graph (A) that a person, or an officer, employee, or gov- erning board member of a person, is
p.000199: or is not deemed to be an employee of the Department of Health and Human Services shall be final and
p.000199: binding on the Secretary and the Attorney General and other parties to any civil action or proceeding.
p.000199: (4) NUMBER OF PERSONAL SERVICES CONTRACTS LIMITED.— The number of experts and consultants whose personal
p.000199: serv- ices are obtained under paragraph (1) shall not exceed 30 at any time.
p.000199: (e) STREAMLINED PERSONNEL AUTHORITY.—
p.000199: (1) IN GENERAL.—In addition to any other personnel au- thorities, the Secretary may, as the Secretary
p.000199: determines nec- essary to respond to pressing qualified countermeasure re- search and development needs
p.000199: under this section, without re- gard to those provisions of title 5, United States Code, gov- erning
p.000199: appointments in the competitive service, and without regard to the provisions of chapter 51 and
p.000199: subchapter III of
p.000199: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000201: PUBLIC HEALTH SERVICE ACT
p.000201: Sec. 319F–2
p.000201:
p.000201: chapter 53 of such title relating to classification and General Schedule pay rates, appoint professional and
p.000201: technical employ- ees, not to exceed 30 such employees at any time, to positions in the National Institutes of Health
p.000201: to perform, administer, or support qualified countermeasure research and development activities in carrying out
p.000201: this section.
p.000201: (2) LIMITATIONS.—The authority provided for under para- graph (1) shall be exercised in a manner that—
p.000201: (A) recruits and appoints individuals based solely on their abilities, knowledge, and skills;
p.000201: (B) does not discriminate for or against any applicant for employment on any basis described
p.000201: in section 2302(b)(1) of title 5, United States Code;
p.000201: (C) does not allow an official to appoint an individual who is a relative (as defined in section
p.000201: 3110(a)(3) of such title) of such official;
p.000201: (D) does not discriminate for or against an individual because of the exercise of any activity described
p.000201: in para- graph (9) or (10) of section 2302(b) of such title; and
p.000201: (E) accords a preference, among equally qualified per- sons, to persons who are preference eligibles (as defined in
p.000201: section 2108(3) of such title).
p.000201: (3) INTERNAL CONTROLS TO BE INSTITUTED.—The Secretary shall institute appropriate internal controls for
p.000201: appointments under this subsection.
p.000201: (f) ACTIONS COMMITTED TO AGENCY DISCRETION.—Actions by the Secretary under the authority of this section are
p.000201: committed to agency discretion.
p.000201: SEC. 319F–2. ø247d–6b¿ STRATEGIC NATIONAL STOCKPILE AND SECU-
p.000201: RITY COUNTERMEASURE PROCUREMENTS. 22
p.000201: (a) STRATEGIC NATIONAL STOCKPILE.—
p.000201: (1) IN GENERAL.—The Secretary, in collaboration with the Assistant Secretary for Preparedness and Response and
p.000201: the Di- rector of the Centers for Disease Control and Prevention, and in coordination with the Secretary
p.000201: of Homeland Security (re- ferred to in this section as the ‘‘Homeland Security Secretary’’), shall maintain a
p.000201: stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other
p.000201: supplies in such numbers, types, and amounts as are determined con- sistent with section 2811 by the
p.000201: Secretary to be appropriate and practicable, taking into account other available sources, to provide for and
p.000201: optimize the emergency health security of the United States, including the emergency health security of chil-
p.000201: dren and other vulnerable populations, in the event of a bioter- rorist attack or other public health emergency and, as
p.000201: informed by existing recommendations of, or consultations with, the Public Health Emergency Medical
p.000201: Countermeasure Enterprise established under section 2811–1, make necessary additions or modifications to the
p.000201: contents of such stockpile or stockpiles based on the review conducted under paragraph (2).
...

p.000203: pro- curement, modification, or replenishment;
p.000203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000205: PUBLIC HEALTH SERVICE ACT
p.000205: Sec. 319F–2
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p.000205: (iii) an assessment of the plans developed by the Secretary for the deployment, distribution, and dis-
p.000205: pensing of countermeasures procured, modified, or re- plenished under paragraph (1), including whether
p.000205: such plans were developed prior to procurement, modi- fication, or replenishment;
p.000205: (iv) an accounting of countermeasures procured, modified, or replenished under paragraph (1) that re-
p.000205: ceived advanced research and development funding from the Biomedical Advanced Research and Develop- ment
p.000205: Authority;
p.000205: (v) an analysis of how such procurement decisions made progress toward meeting emergency health secu- rity needs
p.000205: related to the identified threats for counter- measures added, modified, or replenished under para- graph (1);
p.000205: (vi) a description of the resources expended re- lated to the procurement of countermeasures (includ- ing
p.000205: additions, modifications, and replenishments) in the stockpile, and how such expenditures relate to the ability of
p.000205: the stockpile to meet emergency health secu- rity needs;
p.000205: (vii) an assessment of the extent to which addi- tions, modifications, and replenishments reviewed
p.000205: under paragraph (2) align with previous relevant re- ports or reviews by the Secretary or the
p.000205: Comptroller General;
p.000205: (viii) with respect to any change in the Federal or- ganizational management of the stockpile, an assess- ment
p.000205: and comparison of the processes affected by such change, including planning for potential counter- measure
p.000205: deployment, distribution, or dispensing capa- bilities and processes related to procurement decisions, use of
p.000205: stockpiled countermeasures, and use of re- sources for such activities; and
p.000205: (ix) an assessment of whether the processes and procedures described by the Secretary pursuant to sec- tion
p.000205: 403(b) of the Pandemic and All-Hazards Pre- paredness and Advancing Innovation Act of 2019 are
p.000205: sufficient to ensure countermeasures and products under consideration for procurement pursuant to sub-
p.000205: section (a) receive the same consideration regardless of whether such countermeasures and products receive or had
p.000205: received funding under section 319L, including with respect to whether such countermeasures and products
p.000205: are most appropriate to meet the emergency health security needs of the United States.
p.000205: (B) SUBMISSION.—Not later than 6 months after com- pleting a classified version of the review under
p.000205: subpara- graph (A), the Comptroller General shall submit an un- classified version of the review to the
p.000205: congressional com- mittees of jurisdiction.
p.000205: (b) SMALLPOX VACCINE DEVELOPMENT.—
p.000205: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000205:
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p.000205: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 206
p.000205:
p.000205: (1) IN GENERAL.—The Secretary shall award contracts, enter into cooperative agreements, or carry out
p.000205: such other ac- tivities as may reasonably be required in order to ensure that the stockpile under
p.000205: subsection (a) includes an amount of vac- cine against smallpox as determined by such Secretary to be
p.000205: sufficient to meet the health security needs of the United States.
p.000205: (2) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to limit the private distribution, purchase,
p.000205: or sale of vaccines from sources other than the stockpile described in subsection (a).
p.000205: (c) ADDITIONAL AUTHORITY REGARDING PROCUREMENT OF CER- TAIN COUNTERMEASURES; AVAILABILITY OF
p.000205: SPECIAL RESERVE FUND.—
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p.000205: January 30, 2020
p.000205: (1) IN GENERAL.—
p.000205: (A) USE OF FUND.—A security countermeasure may, in accordance with this subsection, be procured with amounts in the
p.000205: special reserve fund as defined in subsection (h).
p.000205: (B) SECURITY COUNTERMEASURE.—For purposes of this subsection, the term ‘‘security countermeasure’’ means a drug
p.000205: (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42
p.000205: U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act
p.000205: (21 U.S.C. 321(h))) that—
p.000205: (i)(I) the Secretary determines to be a priority (consistent with sections 302(2) and 304(a) of
p.000205: the Homeland Security Act of 2002) to diagnose, mitigate, prevent, or treat harm from any biological, chemical,
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p.000213: PUBLIC HEALTH SERVICE ACT
p.000213: Sec. 319F–2
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p.000213: January 30, 2020
p.000213: U.S.C. 254d) (relating to the examination of contractor records).
p.000213: (dd) Section 3131 of title 40, United States Code (relating to bonds of contractors of public
p.000213: buildings or works).
p.000213: (ee) Subsection (a) of section 304 of the Federal Property and Administrative Services Act of 1949 (41 U.S.C.
p.000213: 254(a)) (relating to con- tingent fees to middlemen).
p.000213: (ff) Section 6002 of the Solid Waste Dis- posal Act (42 U.S.C. 6962).
p.000213: (gg) Section 1354 of title 31, United States Code (relating to the limitation on the use of
p.000213: appropriated funds for contracts with entities not meeting veterans employment re- porting requirements).
p.000213: (III) INTERNAL CONTROLS TO BE ESTAB- LISHED.—The Secretary shall establish appro- priate
p.000213: internal controls for procurements made under this clause, including requirements with re- spect to documentation
p.000213: of the justification for the use of the authority provided under this para- graph with respect to the
p.000213: procurement involved.
p.000213: (IV) AUTHORITY TO LIMIT COMPETITION.—In conducting a procurement under this subpara- graph, the
p.000213: Secretary may not use the authority provided for under subclause (I) to conduct a pro- curement on a basis other
p.000213: than full and open com- petition unless the Secretary determines that the mission of the BioShield
p.000213: Program under the Project BioShield Act of 2004 would be seriously impaired without such a limitation.
p.000213: (iv) PROCEDURES OTHER THAN FULL AND OPEN COMPETITION.—
p.000213: (I) IN GENERAL.—In using the authority pro- vided in section 303(c)(1) of title III of the Federal Property and
p.000213: Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to use procedures other than competitive procedures in
p.000213: the case of a procure- ment under this subsection, the phrase ‘‘available from only one responsible source’’
p.000213: in such section 303(c)(1) shall be deemed to mean ‘‘available from only one responsible source or only from a limited
p.000213: number of responsible sources’’.
p.000213: (II) RELATION TO OTHER AUTHORITIES.—The authority under subclause (I) is in addition to any other authority to
p.000213: use procedures other than com- petitive procedures.
p.000213: (III) APPLICABLE GOVERNMENT-WIDE REGULA- TIONS.—The Secretary shall implement this clause in accordance with
p.000213: government-wide regulations implementing such section 303(c)(1) (including re- quirements that offers be solicited
p.000213: from as many potential sources as is practicable under the cir-
p.000213: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000213: Sec. 319F–2 PUBLIC HEALTH SERVICE ACT 214
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p.000213: January 30, 2020
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p.000213: cumstances, that required notices be published, and that submitted offers be considered), as such
p.000213: regulations apply to procurements for which an agency has authority to use procedures other than competitive
p.000213: procedures when the property or serv- ices needed by the agency are available from only one responsible source or
p.000213: only from a limited number of responsible sources and no other type of property or services will satisfy
p.000213: the needs of the agency.
p.000213: (v) PREMIUM PROVISION IN MULTIPLE AWARD CON- TRACTS.—
p.000213: (I) IN GENERAL.—If, under this subsection, the Secretary enters into contracts with more than one vendor to
p.000213: procure a security countermeasure, such Secretary may, notwithstanding any other provision of law, include in
p.000213: each of such contracts a provision that—
p.000213: (aa) identifies an increment of the total quantity of security countermeasure required, whether by percentage
p.000213: or by numbers of units; and
p.000213: (bb) promises to pay one or more specified premiums based on the priority of such ven- dors’ production and
p.000213: delivery of the increment identified under item (aa), in accordance with the terms and conditions of the contract.
p.000213: (II) DETERMINATION OF GOVERNMENT’S RE- QUIREMENT NOT REVIEWABLE.—If the Secretary in- cludes in each of
p.000213: a set of contracts a provision as described in subclause (I), such Secretary’s deter- mination of the
p.000213: total quantity of security counter- measure required, and any amendment of such determination, is committed to
p.000213: agency discretion.
p.000213: (vi) EXTENSION OF CLOSING DATE FOR RECEIPT OF PROPOSALS NOT REVIEWABLE.—A decision by the Sec- retary to
p.000213: extend the closing date for receipt of pro- posals for a procurement under this subsection is com- mitted to
p.000213: agency discretion.
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p.000215: PUBLIC HEALTH SERVICE ACT
p.000215: Sec. 319F–2
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p.000215: sonable, allowable, and allocable direct cost of the con- tract involved.
p.000215: (8) INTERAGENCY COOPERATION.—
p.000215: (A) IN GENERAL.—In carrying out activities under this section, the Homeland Security Secretary and the Sec-
p.000215: retary are authorized, subject to subparagraph (B), to enter into interagency agreements and other
p.000215: collaborative undertakings with other agencies of the United States Government. Such agreements may allow
p.000215: other executive agencies to order qualified and security countermeasures under procurement contracts or
p.000215: other agreements estab- lished by the Secretary. Such ordering process (including transfers of appropriated
p.000215: funds between an agency and the Department of Health and Human Services as reimburse- ments for such orders
p.000215: for countermeasures) may be con- ducted under the authority of section 1535 of title 31, United States
p.000215: Code, except that all such orders shall be processed under the terms established under this sub- section
p.000215: for the procurement of countermeasures.
p.000215: (B) LIMITATION.—An agreement or undertaking under this paragraph shall not authorize another agency to exer- cise
p.000215: the authorities provided by this section to the Home- land Security Secretary or to the Secretary.
p.000215: (d) DISCLOSURES.—No Federal agency may disclose under sec- tion 552 of title 5, United States Code any
p.000215: information identifying the location at which materials in the stockpile described in sub- section (a) are
p.000215: stored, or other information regarding the contents or deployment capability of the stockpile that could
p.000215: compromise na- tional security.
p.000215: (e) DEFINITION.—For purposes of subsection (a), the term ‘‘stockpile’’ includes—
p.000215: (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or
p.000215: (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or
p.000215: vendors agree to provide to such Secretary supplies described in subsection (a).
p.000215: (f) AUTHORIZATION OF APPROPRIATIONS.—
p.000215: (1) STRATEGIC NATIONAL STOCKPILE.—For the purpose of carrying out subsection (a), there are authorized
p.000215: to be appro- priated $610,000,000 for each of fiscal years 2019 through 2023, to remain available until
p.000215: expended. Such authorization is in addition to amounts in the special reserve fund referred to in
p.000215: subsection (h).
p.000215: (2) SMALLPOX VACCINE DEVELOPMENT.—For the purpose of carrying out subsection (b), there are authorized to
p.000215: be appro- priated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of
p.000215: fiscal years 2003 through 2006.
p.000215: (g) SPECIAL RESERVE FUND.—
p.000215: (1) AUTHORIZATION OF APPROPRIATIONS.—In addition to amounts appropriated to the special reserve fund
p.000215: prior to the date of the enactment of this subsection, there is authorized to be appropriated, for the
p.000215: procurement of security counter- measures under subsection (c) and for carrying out section
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000215: January 30, 2020
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p.000215: 319L (relating to the Biomedical Advanced Research and De- velopment Authority), $7,100,000,000 for the
p.000215: period of fiscal years 2019 through 2028, to remain available until expended.
p.000215: (2) USE OF SPECIAL RESERVE FUND FOR ADVANCED RE- SEARCH AND DEVELOPMENT.—The Secretary may
p.000215: utilize not more than 50 percent of the amounts authorized to be appro- priated under paragraph (1) to carry
p.000215: out section 319L (related to the Biomedical Advanced Research and Development Au- thority). Amounts authorized
p.000215: to be appropriated under this subsection to carry out section 319L are in addition to amounts otherwise authorized
p.000215: to be appropriated to carry out such sec- tion.
p.000215: (3) RESTRICTIONS ON USE OF FUNDS.—Amounts in the spe- cial reserve fund shall not be used to pay costs other than
p.000215: pay- ments made by the Secretary to a vendor for advanced develop- ment (under section 319L) or for procurement
p.000215: of a security countermeasure under subsection (c)(7).
p.000215: (4) REPORT ON SECURITY COUNTERMEASURE PROCURE- MENT.—Not later than March 1 of each year in which the
p.000215: Sec- retary determines that the amount of funds available for pro- curement of security
p.000215: countermeasures is less than
p.000215: $1,500,000,000, the Secretary shall submit to the Committee on Appropriations and the Committee on Health,
p.000215: Education, Labor, and Pensions of the Senate and the Committee on Ap- propriations and the Committee on
p.000215: Energy and Commerce of the House of Representatives a report detailing the amount of such funds available for
p.000215: procurement and the impact such amount of funding will have—
p.000215: (A) in meeting the security countermeasure needs identified under this section; and
p.000215: (B) on the annual Public Health Emergency Medical Countermeasures Enterprise and Strategy Implementation Plan
p.000215: (pursuant to section 2811(d)).
p.000215: (5) CLARIFICATION ON CONTRACTING AUTHORITY.—The Sec- retary, acting through the Director of the Biomedical
p.000215: Advanced Research and Development Authority, shall carry out the pro- grams funded by the special reserve fund
p.000215: (for the procurement of security countermeasures under subsection (c) and for car- rying out section 319L),
p.000215: including the execution of procurement contracts, grants, and cooperative agreements pursuant to this section and
p.000215: section 319L.
p.000215: (h) DEFINITIONS.—In this section:
p.000215: (1) The term ‘‘advanced research and development’’ has the meaning given such term in section 319L(a).
p.000215: (2) The term ‘‘special reserve fund’’ means the ‘‘Biodefense Countermeasures’’ appropriations account, any
p.000215: appropriation made available pursuant to section 521(a) of the Homeland Se- curity Act of 2002, and any appropriation
p.000215: made available pur- suant to subsection (g)(1).
p.000215: SEC. 319F–3. ø247d–6d¿ TARGETED LIABILITY PROTECTIONS FOR PAN- DEMIC AND EPIDEMIC PRODUCTS AND SECURITY
p.000215: COUN- TERMEASURES.
p.000215: (a) LIABILITY PROTECTIONS.—
p.000215: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000217: PUBLIC HEALTH SERVICE ACT
p.000217: Sec. 319F–3
p.000217:
p.000217: (1) IN GENERAL.—Subject to the other provisions of this section, a covered person shall be immune from suit and
p.000217: liabil- ity under Federal and State law with respect to all claims for loss caused by, arising out of,
p.000217: relating to, or resulting from the administration to or the use by an individual of a covered countermeasure
p.000217: if a declaration under subsection (b) has been issued with respect to such countermeasure.
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p.000217: by an individual in accordance with the conditions described in paragraph (3)(C).
p.000217: (B) In the case of a covered person who is a program planner or qualified person with respect to the
p.000217: administra- tion or use of the covered countermeasure, the scope of im- munity includes circumstances in which
p.000217: the counter- measure was administered to or used by an individual in circumstances in which the
p.000217: covered person reasonably could have believed that the countermeasure was adminis- tered or used in accordance
p.000217: with the conditions described in paragraph (3)(C).
p.000217: (5) EFFECT OF DISTRIBUTION METHOD.—The provisions of this section apply to a covered countermeasure
p.000217: regardless of whether such countermeasure is obtained by donation, com- mercial sale, or any other means
p.000217: of distribution, except to the extent that, under paragraph (2)(E) of subsection (b), the dec- laration
p.000217: under such subsection provides that subsection (a) ap- plies only to covered countermeasures obtained through a par-
p.000217: ticular means of distribution.
p.000217: (6) REBUTTABLE PRESUMPTION.—For purposes of paragraph (1), there shall be a rebuttable presumption that any
p.000217: adminis- tration or use, during the effective period of the emergency dec- laration by the Secretary under
p.000217: subsection (b), of a covered countermeasure shall have been for the category or categories of diseases,
p.000217: health conditions, or threats to health with respect to which such declaration was issued.
p.000217: (b) DECLARATION BY SECRETARY.—
p.000217: (1) AUTHORITY TO ISSUE DECLARATION.—Subject to para- graph (2), if the Secretary makes a determination
p.000217: that a dis- ease or other health condition or other threat to health con- stitutes a public health
p.000217: emergency, or that there is a credible risk that the disease, condition, or threat may in the future
p.000217: constitute such an emergency, the Secretary may make a dec- laration, through publication in the Federal
p.000217: Register, recom- mending, under conditions as the Secretary may specify, the manufacture, testing,
p.000217: development, distribution, administra- tion, or use of one or more covered countermeasures, and stat- ing that
p.000217: subsection (a) is in effect with respect to the activities so recommended.
p.000217: (2) CONTENTS.—In issuing a declaration under paragraph (1), the Secretary shall identify, for each covered
p.000217: counter- measure specified in the declaration—
p.000217: (A) the category or categories of diseases, health condi- tions, or threats to health for which the Secretary
p.000217: rec- ommends the administration or use of the countermeasure;
p.000217: (B) the period or periods during which, including as modified by paragraph (3), subsection (a) is in effect,
p.000217: which period or periods may be designated by dates, or by mile- stones or other description of events,
p.000217: including factors specified in paragraph (6);
p.000217: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000219: (i) intentionally to achieve a wrongful purpose;
p.000219: (ii) knowingly without legal or factual justifica- tion; and
p.000219: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000221: PUBLIC HEALTH SERVICE ACT
p.000221: Sec. 319F–3
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p.000221: (iii) in disregard of a known or obvious risk that is so great as to make it highly probable that
p.000221: the harm will outweigh the benefit.
p.000221: (B) RULE OF CONSTRUCTION.—The criterion stated in subparagraph (A) shall be construed as establishing
p.000221: a standard for liability that is more stringent than a stand- ard of negligence in any form or recklessness.
p.000221: (2) AUTHORITY TO PROMULGATE REGULATORY DEFINITION.—
p.000221: (A) IN GENERAL.—The Secretary, in consultation with the Attorney General, shall promulgate regulations, which may
p.000221: be promulgated through interim final rules, that fur- ther restrict the scope of actions or omissions by a covered
p.000221: person that may qualify as ‘‘willful misconduct’’ for pur- poses of subsection (d).
p.000221: (B) FACTORS TO BE CONSIDERED.—In promulgating the regulations under this paragraph, the Secretary, in con-
p.000221: sultation with the Attorney General, shall consider the need to define the scope of permissible civil
p.000221: actions under subsection (d) in a way that will not adversely affect the public health.
p.000221: (C) TEMPORAL SCOPE OF REGULATIONS.—The regula- tions under this paragraph may specify the temporal effect that
p.000221: they shall be given for purposes of subsection (d).
p.000221: (D) INITIAL RULEMAKING.—Within 180 days after the enactment of the Public Readiness and Emergency Pre-
p.000221: paredness Act, the Secretary, in consultation with the At- torney General, shall commence and complete an
p.000221: initial rulemaking process under this paragraph.
p.000221: (3) PROOF OF WILLFUL MISCONDUCT.—In an action under subsection (d), the plaintiff shall have the burden of
p.000221: proving by clear and convincing evidence willful misconduct by each cov- ered person sued and that such
p.000221: willful misconduct caused death or serious physical injury.
p.000221: (4) DEFENSE FOR ACTS OR OMISSIONS TAKEN PURSUANT TO SECRETARY’S DECLARATION.—Notwithstanding any other
p.000221: provi- sion of law, a program planner or qualified person shall not have engaged in ‘‘willful misconduct’’ as
p.000221: a matter of law where such program planner or qualified person acted consistent with applicable directions,
p.000221: guidelines, or recommendations by the Secretary regarding the administration or use of a covered
p.000221: countermeasure that is specified in the declaration under sub- section (b), provided either the Secretary, or a
p.000221: State or local health authority, was provided with notice of information re- garding serious physical
p.000221: injury or death from the administra- tion or use of a covered countermeasure that is material to the plaintiff’s
p.000221: alleged loss within 7 days of the actual discovery of such information by such program planner or qualified
p.000221: person.
p.000221: (5) EXCLUSION FOR REGULATED ACTIVITY OF MANUFACTURER OR DISTRIBUTOR.—
p.000221: (A) IN GENERAL.—If an act or omission by a manufac- turer or distributor with respect to a covered counter-
p.000221: measure, which act or omission is alleged under subsection (e)(3)(A) to constitute willful misconduct, is subject to
p.000221: regu- lation by this Act or by the Federal Food, Drug, and Cos-
p.000221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000221: Sec. 319F–3 PUBLIC HEALTH SERVICE ACT 222
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p.000225: loss of consortium, hedonic damages, injury to reputation, and any other nonpecuniary losses.
p.000225: (9) RULE 11 SANCTIONS.—Whenever a district court of the United States determines that there has been a
p.000225: violation of Rule 11 of the Federal Rules of Civil Procedure in an action under subsection (d), the court
p.000225: shall impose upon the attorney, law firm, or parties that have violated Rule 11 or are respon- sible for
p.000225: the violation, an appropriate sanction, which may in- clude an order to pay the other party or parties for the
p.000225: reason- able expenses incurred as a direct result of the filing of the pleading, motion, or other paper that
p.000225: is the subject of the viola- tion, including a reasonable attorney’s fee. Such sanction shall be sufficient to deter
p.000225: repetition of such conduct or comparable conduct by others similarly situated, and to compensate the
p.000225: party or parties injured by such conduct.
p.000225: (10) INTERLOCUTORY APPEAL.—The United States Court of Appeals for the District of Columbia Circuit shall have
p.000225: jurisdic- tion of an interlocutory appeal by a covered person taken with- in 30 days of an order denying a motion to
p.000225: dismiss or a motion for summary judgment based on an assertion of the immunity from suit conferred by subsection
p.000225: (a) or based on an assertion of the exclusion under subsection (c)(5).
p.000225: (f) ACTIONS BY AND AGAINST THE UNITED STATES.—Nothing in this section shall be construed to abrogate or limit any
p.000225: right, rem- edy, or authority that the United States or any agency thereof may possess under any other provision of law
p.000225: or to waive sovereign im- munity or to abrogate or limit any defense or protection available to the United
p.000225: States or its agencies, instrumentalities, officers, or employees under any other law, including any provision of
p.000225: chapter 171 of title 28, United States Code (relating to tort claims proce- dure).
p.000225: (g) SEVERABILITY.—If any provision of this section, or the appli- cation of such provision to any person or
p.000225: circumstance, is held to be unconstitutional, the remainder of this section and the applica- tion of such
p.000225: remainder to any person or circumstance shall not be affected thereby.
p.000225: (h) RULE OF CONSTRUCTION CONCERNING NATIONAL VACCINE INJURY COMPENSATION PROGRAM.—Nothing in this
p.000225: section, or any amendment made by the Public Readiness and Emergency Pre- paredness Act, shall be construed
p.000225: to affect the National Vaccine In- jury Compensation Program under title XXI of this Act.
p.000225: (i) DEFINITIONS.—In this section:
p.000225: (1) COVERED COUNTERMEASURE.—The term ‘‘covered coun- termeasure’’ means—
p.000225: (A) a qualified pandemic or epidemic product (as de- fined in paragraph (7));
p.000225: (B) a security countermeasure (as defined in section 319F–2(c)(1)(B)); or
p.000225: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000231: the Senate, and the Committee on Commerce and the Committee on Appropriations of the House of
p.000231: Representatives, a report that de- scribes the ability of grantees under such subsection to detect
p.000231: pathogens likely to be used in a bioterrorist attack, develop plans and measures for dealing with such
p.000231: threats, and train personnel involved with the various responsibilities and capabilities needed to deal with
p.000231: bioterrorist threats.
p.000231: (g) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section
p.000231: $6,000,000 for fiscal year 2001, and such sums as may be necessary through fiscal year 2006.
p.000231: SEC. 319H. ø247d–7a¿ GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH PROFESSIONALS.
p.000231: (a) IN GENERAL.—The Secretary may make awards of grants and cooperative agreements to appropriate public
p.000231: and nonprofit private health or educational entities, including health professions schools and programs as
p.000231: defined in section 799B, for the purpose of providing low-interest loans, partial scholarships, partial fellow-
p.000231: ships, revolving loan funds, or other cost-sharing forms of assist- ance for the education and training
p.000231: of individuals in any category of health professions for which there is a shortage that the Sec- retary
p.000231: determines should be alleviated in order to prepare for or re- spond effectively to bioterrorism and other public
p.000231: health emer- gencies.
p.000231: (b) AUTHORITY REGARDING NON-FEDERAL CONTRIBUTIONS.— The Secretary may require as a condition of an
p.000231: award under sub- section (a) that a grantee under such subsection provide non-Fed- eral contributions toward
p.000231: the purpose described in such subsection.
p.000231: (c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000231: to be appropriated
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p.000231: January 30, 2020
p.000231: 24 Now the Government Accountability Office. See section 8 of Public Law 108–271 (118 Stat. 814).
p.000231: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000233: PUBLIC HEALTH SERVICE ACT
p.000233: Sec. 319I
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p.000233: such sums as may be necessary for each of the fiscal years 2002 through 2006.
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p.000233: Services.
p.000233: (b) CORRESPONDING REDUCTION IN PAYMENTS.—With respect to a request described in subsection (a), the Secretary shall
p.000233: reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the
p.000233: fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for
p.000233: the payment of expenses incurred in complying with such request, expend the amounts withheld.
p.000233: SEC. 319K. ø247d–7d¿ SECURITY FOR COUNTERMEASURE DEVELOP- MENT AND PRODUCTION.
p.000233: (a) IN GENERAL.—The Secretary, in consultation with the At- torney General and the Secretary of Defense, may
p.000233: provide technical or other assistance to provide security to persons or facilities that conduct development,
p.000233: production, distribution, or storage of priority countermeasures (as defined in section 319F(e)(4)).
p.000233: (b) GUIDELINES.—The Secretary may develop guidelines to en- able entities eligible to receive assistance
p.000233: under subsection (a) to secure their facilities against potential terrorist attack.
p.000233: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000235: PUBLIC HEALTH SERVICE ACT
p.000235: Sec. 319L
p.000235:
p.000235: SEC. 319L. ø247d–7e¿ BIOMEDICAL ADVANCED RESEARCH AND DEVEL- OPMENT AUTHORITY.
p.000235: (a) DEFINITIONS.—In this section:
p.000235: (1) BARDA.—The term ‘‘BARDA’’ means the Biomedical Advanced Research and Development Authority.
p.000235: (2) FUND.—The term ‘‘Fund’’ means the Biodefense Med- ical Countermeasure Development Fund established
p.000235: under subsection (d).
p.000235: (3) OTHER TRANSACTIONS.—The term ‘‘other transactions’’ means transactions, other than procurement contracts,
p.000235: grants, and cooperative agreements.
p.000235: (4) QUALIFIED COUNTERMEASURE.—The term ‘‘qualified countermeasure’’ has the meaning given such term in
p.000235: section 319F–1.
p.000235: (5) QUALIFIED PANDEMIC OR EPIDEMIC PRODUCT.—The term ‘‘qualified pandemic or epidemic product’’ has the
p.000235: meaning given the term in section 319F–3.
p.000235: (6) ADVANCED RESEARCH AND DEVELOPMENT.—
p.000235: (A) IN GENERAL.—The term ‘‘advanced research and development’’ means, with respect to a product that is
p.000235: or may become a qualified countermeasure or a qualified pan- demic or epidemic product, activities that predominantly—
p.000235: (i) are conducted after basic research and pre- clinical development of the product; and
p.000235: (ii) are related to manufacturing the product on a commercial scale and in a form that satisfies the regu- latory
p.000235: requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act.
p.000235: (B) ACTIVITIES INCLUDED.—The term under subpara- graph (A) includes—
p.000235: (i) testing of the product to determine whether the product may be approved, cleared, or licensed under the
p.000235: Federal Food, Drug, and Cosmetic Act or under section 351 of this Act for a use that is or may be the basis for
p.000235: such product becoming a qualified counter- measure or qualified pandemic or epidemic product, or to help obtain
p.000235: such approval, clearance, or license;
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p.000235: for innovation, and the procurement of qualified countermeasures and qualified pandemic or epidemic products. The
p.000235: Secretary shall carry out such activities as may be practicable to disseminate the information contained in
p.000235: such plan to persons who may have the capacity to substantially contribute to the activities described in
p.000235: such strategic plan. The Secretary shall update and incorporate such plan as part of the National Health
p.000235: Security Strategy described in section 2802.
p.000235: (2) CONTENT.—The strategic plan under paragraph (1) shall guide—
p.000235: (A) research and development, conducted or supported by the Department of Health and Human Services, of
p.000235: qualified countermeasures and qualified pandemic or epi- demic products against possible biological, chemical,
p.000235: radio- logical, and nuclear agents and to emerging infectious dis- eases;
p.000235: (B) innovation in technologies that may assist ad- vanced research and development of qualified
p.000235: counter- measures and qualified pandemic or epidemic products (such research and development referred to in this
p.000235: section as ‘‘countermeasure and product advanced research and development’’); and
p.000235: (C) procurement of such qualified countermeasures and qualified pandemic or epidemic products by such
p.000235: De- partment.
p.000235: (c) BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AU-
p.000235: THORITY.—
p.000235: (1) ESTABLISHMENT.—There is established within the De- partment of Health and Human Services the
p.000235: Biomedical Ad- vanced Research and Development Authority.
p.000235: (2) IN GENERAL.—Based upon the strategic plan described in subsection (b), the Secretary shall coordinate
p.000235: the accelera- tion of countermeasure and product advanced research and de- velopment by—
p.000235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000237: PUBLIC HEALTH SERVICE ACT
p.000237: Sec. 319L
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p.000237: (A) facilitating collaboration between the Department of Health and Human Services and other Federal agencies,
p.000237: relevant industries, academia, and other persons, with re- spect to such advanced research and development;
p.000237: (B) promoting countermeasure and product advanced research and development;
p.000237: (C) facilitating contacts between interested persons and the offices or employees authorized by the
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p.000241: Sec. 319L PUBLIC HEALTH SERVICE ACT 242
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p.000241: January 30, 2020
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p.000241: search and development of such countermeasures (in- cluding multiuse platform technologies for diagnostics,
p.000241: vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and
p.000241: adjuvant material); and
p.000241: (iii) threats that may result primarily or second- arily from a chemical, biological, radiological, or
p.000241: nu- clear agent, or emerging infectious diseases, and which may present increased treatment
p.000241: complications such as the occurrence of resistance to available coun- termeasures or potential countermeasures,
p.000241: including antimicrobial resistant pathogens.
p.000241: (5) TRANSACTION AUTHORITIES.—
p.000241: (A) OTHER TRANSACTIONS.—
p.000241: (i) IN GENERAL.—The Secretary shall have the au- thority to enter into other transactions (as defined in
p.000241: subsection (a)(3)) under this subsection.
p.000241: (ii) LIMITATIONS ON AUTHORITY.—
p.000241: (I) IN GENERAL.—To the maximum extent practicable, competitive procedures shall be used when entering
p.000241: into transactions to carry out projects under this subsection.
p.000241: (II) WRITTEN DETERMINATIONS REQUIRED.— The authority of this subparagraph may be exer- cised for a
p.000241: project that is expected to cost the De- partment of Health and Human Services in excess of $100,000,000 only upon a
p.000241: written determination by the Assistant Secretary for Financial Re- sources, that the use of such authority
p.000241: is essential to promoting the success of the project. The au- thority of the Assistant Secretary for
p.000241: Financial Resources under this subclause may not be dele- gated.
p.000241: (iii) GUIDELINES.—The Secretary shall establish guidelines regarding the use of the authority under clause
p.000241: (i). Such guidelines shall include auditing re- quirements.
p.000241: (B) EXPEDITED AUTHORITIES.—
p.000241: (i) IN GENERAL.—In awarding contracts, grants, and cooperative agreements, and in entering into other
p.000241: transactions under subparagraph (B) or (D) of paragraph (4), the Secretary shall have the expedited
p.000241: procurement authorities, the authority to expedite peer review, and the authority for personal
p.000241: services contracts, supplied by subsections (b), (c), and (d) of section 319F–1.
p.000241: (ii) APPLICATION OF PROVISIONS.—Provisions in such section 319F–1 that apply to such authorities and that
p.000241: require institution of internal controls, limit re- view, provide for Federal Tort Claims Act coverage of
p.000241: personal services contractors, and commit decisions to the discretion of the Secretary shall apply to the au-
p.000241: thorities as exercised pursuant to this paragraph.
p.000241: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000243: PUBLIC HEALTH SERVICE ACT
p.000243: Sec. 319L
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p.000243: January 30, 2020
p.000243: (iii) AUTHORITY TO LIMIT COMPETITION.—For pur- poses of applying section 319F–1(b)(1)(D) to this para- graph,
p.000243: the phrase ‘‘BioShield Program under the Project BioShield Act of 2004’’ shall be deemed to mean the
p.000243: countermeasure and product advanced re- search and development program under this section.
p.000243: (iv) AVAILABILITY OF DATA.—The Secretary shall require that, as a condition of being awarded a con-
p.000243: tract, grant, cooperative agreement, or other trans- action under subparagraph (B) or (D) of paragraph (4), a
p.000243: person make available to the Secretary on an ongo- ing basis, and submit upon request to the Secretary,
p.000243: all data related to or resulting from countermeasure and product advanced research and development car-
p.000243: ried out pursuant to this section.
p.000243: (C) ADVANCE PAYMENTS; ADVERTISING.—The Secretary may waive the requirements of section 3324(a) of title
p.000243: 31, United States Code, or section 3709 of the Revised Stat- utes of the United States (41 U.S.C. 5)
p.000243: upon the deter- mination by the Secretary that such waiver is necessary to obtain countermeasures or products under
p.000243: this section.
p.000243: (D) MILESTONE-BASED PAYMENTS ALLOWED.—In award- ing contracts, grants, and cooperative agreements, and in
p.000243: entering into other transactions, under this section, the Secretary may use milestone-based awards and payments.
p.000243: (E) FOREIGN NATIONALS ELIGIBLE.—The Secretary may under this section award contracts, grants, and cooperative
p.000243: agreements to, and may enter into other transactions with, highly qualified foreign national persons outside
p.000243: the United States, alone or in collaboration with American participants, when such transactions may inure to
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p.000243: January 30, 2020
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p.000243: older adults, and other at-risk individuals with relevant char- acteristics that warrant consideration during
p.000243: the process of re- searching and developing such countermeasures and products.
p.000243: (7) PERSONNEL AUTHORITIES.—
p.000243: (A) SPECIALLY QUALIFIED SCIENTIFIC AND PROFES- SIONAL PERSONNEL.—
p.000243: (i) IN GENERAL.—In addition to any other per- sonnel authorities, the Secretary may—
p.000243: (I) without regard to those provisions of title 5, United States Code, governing appointments in the
p.000243: competitive service, appoint highly qualified individuals to scientific or professional positions in BARDA, such
p.000243: as program managers, to carry out this section; and
p.000243: (II) compensate them in the same manner and subject to the same terms and conditions in which individuals appointed
p.000243: under section 9903 of such title are compensated, without regard to the provi- sions of chapter 51 and
p.000243: subchapter III of chapter 53 of such title relating to classification and Gen- eral Schedule pay rates.
p.000243: (ii) MANNER OF EXERCISE OF AUTHORITY.—The au- thority provided for in this subparagraph shall be ex-
p.000243: ercised subject to the same limitations described in section 319F–1(e)(2).
p.000243: (iii) TERM OF APPOINTMENT.—The term limitations described in section 9903(c) of title 5, United States Code,
p.000243: shall apply to appointments under this subpara- graph, except that the references to the ‘‘Secretary’’ and to
p.000243: the ‘‘Department of Defense’s national security missions’’ shall be deemed to be to the Secretary of Health
p.000243: and Human Services and to the mission of the Department of Health and Human Services under this section.
p.000243: (B) SPECIAL CONSULTANTS.—In carrying out this sec- tion, the Secretary may appoint special consultants pursu-
p.000243: ant to section 207(f).
p.000243: (C) LIMITATION.—
p.000243: (i) IN GENERAL.—The Secretary may hire up to 100 highly qualified individuals, or up to 50 percent of the
p.000243: total number of employees, whichever is less, under the authorities provided for in subparagraphs
p.000243: (A) and (B).
p.000243: (ii) REPORT.—The Secretary shall report to Con- gress on a biennial basis on the implementation of this
p.000243: subparagraph.
p.000243: (d) FUND.—
p.000243: (1) ESTABLISHMENT.—There is established the Biodefense Medical Countermeasure Development Fund, which shall
p.000243: be available to carry out this section in addition to such amounts as are otherwise available for this purpose.
p.000243: (2) FUNDING.—To carry out the purposes of this section, there is authorized to be appropriated
p.000243: to the Fund
p.000243: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000245: and not otherwise publicly known vulnerabilities of existing medical or public health de- fenses against
p.000245: chemical, biological, radiological, or nu- clear threats, and is comprised of—
p.000245: (I) specific technical data or scientific informa- tion that is created or obtained during the coun- termeasure
p.000245: and product advanced research and development carried out under subsection (c);
p.000245: (II) information pertaining to the location se- curity, personnel, and research materials and methods
p.000245: of high-containment laboratories con- ducting research with select agents, toxins, or other agents
p.000245: with a material threat determination under section 319F–2(c)(2); or
p.000245: (III) security and vulnerability assessments.
p.000245: (B) REVIEW.—Information subject to nondisclosure under subparagraph (A) shall be reviewed by the Secretary
p.000245: every 5 years, or more frequently as determined necessary by the Secretary, to determine the relevance or
p.000245: necessity of continued nondisclosure.
p.000245: (C) REPORTING.—One year after the date of enactment of the Pandemic and All-Hazards Preparedness and Ad-
p.000245: vancing Innovation Act of 2019, and annually thereafter, the Secretary shall report to the Committee on
p.000245: Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of
p.000245: Rep- resentatives on the number of instances in which the Sec- retary has used the authority under this
p.000245: subsection to withhold information from disclosure, as well as the na- ture of any request under section
p.000245: 552 of title 5, United States Code that was denied using such authority.
p.000245: (D) SUNSET.—This paragraph shall cease to have force or effect on the date that is 17 years after the date of en-
p.000245: actment of the Pandemic and All-Hazards Preparedness Act.
p.000245: (2) REVIEW.—Notwithstanding section 14 of the Federal Advisory Committee Act, a working group of BARDA
p.000245: under this section and the National Biodefense Science Board under section 319M shall each terminate on
p.000245: the date that is 5 years after the date on which each such group or Board, as applica- ble, was established.
p.000245: Such 5-year period may be extended by
p.000245: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000245: Sec. 319L–1 PUBLIC HEALTH SERVICE ACT 246
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p.000245: January 30, 2020
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p.000245: the Secretary for one or more additional 5-year periods if the Secretary determines that any such extension
p.000245: is appropriate.
p.000245: (f) INDEPENDENT EVALUATION.—
p.000245: (1) IN GENERAL.—Not later than 180 days after the date of enactment of this subsection, the Comptroller General
p.000245: of the United States shall conduct an independent evaluation of the activities carried out to facilitate
p.000245: flexible manufacturing capac- ity pursuant to this section.
p.000245: (2) REPORT.—Not later than 1 year after the date of enact- ment of this subsection, the Comptroller General of the
p.000245: United States shall submit to the appropriate committees of Congress a report concerning the results of the
p.000245: evaluation conducted under paragraph (1). Such report shall review and assess—
p.000245: (A) the extent to which flexible manufacturing capac- ity under this section is dedicated to chemical,
p.000245: biological, radiological, and nuclear threats;
p.000245: (B) the activities supported by flexible manufacturing initiatives; and
p.000245: (C) the ability of flexible manufacturing activities car- ried out under this section to—
p.000245: (i) secure and leverage leading technical expertise with respect to countermeasure advanced research, de- velopment,
p.000245: and manufacturing processes; and
p.000245: (ii) meet the surge manufacturing capacity needs presented by novel and emerging threats, including
p.000245: chemical, biological, radiological, and nuclear agents.
p.000245: SEC. 319L–1. ø247d–7f¿ COLLABORATION AND COORDINATION
p.000245: (a) LIMITED ANTITRUST EXEMPTION.—
p.000245: (1) MEETINGS AND CONSULTATIONS TO DISCUSS SECURITY COUNTERMEASURES, QUALIFIED COUNTERMEASURES, OR
p.000245: QUALI- FIED PANDEMIC OR EPIDEMIC PRODUCT DEVELOPMENT.—
p.000245: (A) AUTHORITY TO CONDUCT MEETINGS AND CONSULTA- TIONS.—The Secretary, in coordination with the Attorney
p.000245: General and the Secretary of Homeland Security, may con- duct meetings and consultations with persons engaged in
p.000245: the development of a security countermeasure (as defined in section 319F-2), a qualified countermeasure
p.000245: (as defined in section 319F-1), or a qualified pandemic or epidemic product (as defined in section
p.000245: 319F-3) for the purpose of the development, manufacture, distribution, purchase, or storage of a
p.000245: countermeasure or product. The Secretary may convene such meeting or consultation at the request of the
p.000245: Secretary of Homeland Security, the Attorney Gen- eral, the Chairman of the Federal Trade Commission (re-
p.000245: ferred to in this section as the ‘‘Chairman’’), or any inter- ested person, or upon initiation by the
p.000245: Secretary. The Sec- retary shall give prior notice of any such meeting or con- sultation, and the topics
p.000245: to be discussed, to the Attorney General, the Chairman, and the Secretary of Homeland Security.
p.000245: (B) MEETING AND CONSULTATION CONDITIONS.—A
p.000245: meeting or consultation conducted under subparagraph (A) shall—
p.000245: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000247: PUBLIC HEALTH SERVICE ACT
p.000247: Sec. 319L–1
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p.000247: under paragraph (2), in a written statement to the Secretary, within 15 business days of the receipt of such
p.000247: request. An exemption granted under this paragraph shall take effect immediately.
p.000247: (B) EXTENSION.—The Attorney General may extend the 15-day period referred to in subparagraph (A) for an
p.000247: additional period of not to exceed 10 business days.
p.000247: (C) DETERMINATION.—An exemption shall be granted regarding a written agreement submitted in accordance with
p.000247: paragraph (2) only to the extent that the Attorney General, in consultation with the Chairman and the
p.000247: Sec- retary, finds that the conduct that will be exempted will not have any substantial anticompetitive effect
p.000247: that is not reasonably necessary for ensuring the availability of the countermeasure or product involved.
p.000247: (5) LIMITATION ON AND RENEWAL OF EXEMPTIONS.—An ex- emption granted under paragraph (4) shall be limited
p.000247: to cov- ered activities, and such exemption shall be renewed (with modifications, as appropriate,
p.000247: consistent with the finding de- scribed in paragraph (4)(C)), on the date that is 3 years after the
p.000247: date on which the exemption is granted unless the Attor- ney General in consultation with the Chairman
p.000247: determines that the exemption should not be renewed (with modifications, as appropriate) considering the factors
p.000247: described in paragraph (4).
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p.000247: January 30, 2020
p.000247: (6) AUTHORITY TO OBTAIN INFORMATION.—Consideration by the Attorney General for granting or renewing an
p.000247: exemption submitted under this section shall be considered an antitrust investigation for purposes of the
p.000247: Antitrust Civil Process Act (15
p.000247: U.S.C. 1311 et seq.).
p.000247: (7) LIMITATION ON PARTIES.—The use of any information acquired under an agreement for which an exemption has
p.000247: been granted under paragraph (4), for any purpose other than speci- fied in the exemption, shall be subject to
p.000247: the antitrust laws and any other applicable laws.
p.000247: (8) REPORT.—Not later than one year after the date of en- actment of this Act and biannually thereafter, the
p.000247: Attorney General and the Chairman shall report to Congress on the use of the exemption from the antitrust laws provided
p.000247: by this sub- section.
p.000247: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000249: PUBLIC HEALTH SERVICE ACT
p.000249: Sec. 319L–1
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p.000255: conditions for which the officer or dependent was receiving health care.
p.000255: (2) Health care may be provided under paragraph (1) for a pe- riod of not more than one year from the date of
p.000255: separation of the officer from the Service.
p.000255: (c) The Service shall provide all services referred to in sub- section (a) required by the Coast Guard or
p.000255: Coast and Geodetic Sur- vey and shall perform all duties prescribed by statute in connection with the examinations
p.000255: to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, pro-
p.000255: motion and retirement, and officers of the Service assigned to duty on Coast Guard or Coast and Geodetic Survey
p.000255: vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
p.000255:
p.000255: January 30, 2020 As Amended Through P.L. 116-94,
p.000255: Enacted December 20, 2019
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p.000257: PUBLIC HEALTH SERVICE ACT
p.000257: Sec. 330
p.000257:
p.000257: INTERDEPARTMENTAL WORK
p.000257: SEC. 327. ø254¿ Nothing contained in this part shall affect the authority of the Service to furnish any
p.000257: materials, supplies, or equipment, or perform any work or services, requested in accord- ance with section 7
p.000257: of the Act of May 21, 1920, as amended (U.S.C., 1940 edition, title 31, sec. 686), or the authority of any other execu-
p.000257: tive department to furnish any materials, supplies, or equipment, or perform any work or services,
p.000257: requested by the Department of Health, Education, and Welfare for the Service in accordance with that section.
p.000257:
p.000257: SHARING OF MEDICAL CARE FACILITIES AND RESOURCES
p.000257: SEC. 327A. ø254a¿ (a) For purposes of this section—
p.000257: (1) the term ‘‘specialized health resources’’ means health care resources (whether equipment, space, or
p.000257: personnel) which, because of cost, limited availability, or unusual nature, are ei- ther unique in the health care
p.000257: community or are subject to maximum utilization only through mutual use;
p.000257: (2) the term ‘‘hospital’’, unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.
p.000257: (b) For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide
p.000257: a professional environment therein which will help to attract and retain highly qualified and talented
p.000257: health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and
p.000257: hospitals and other health facilities in the health care commu- nity, and to promote the full utilization of
p.000257: hospitals and other health facilities and resources, the Secretary may—
p.000257: (1) enter into agreements or arrangements with schools of medicine, schools of osteopathic medicine, and
p.000257: with other health professions schools, agencies, or institutions, for such interchange or cooperative use of
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p.000261: (E) expanding the use of telehealth and technology-en- abled collaborative learning and capacity building models;
p.000261: (F) care integration, including integration of behav- ioral health, mental health, or substance use disorder
p.000261: serv- ices; and
p.000261: (G) addressing emerging public health or substance use disorder issues to meet the health needs of the
p.000261: popu- lation served by the health center.
p.000261: (2) SUSTAINABILITY.—In making supplemental awards under this subsection, the Secretary may consider whether the
p.000261: health center involved has submitted a plan for continuing the activities funded under this subsection after
p.000261: supplemental funding is expended.
p.000261: (3) SPECIAL CONSIDERATION.—The Secretary may give spe- cial consideration to applications for supplemental
p.000261: funding under this subsection that seek to address significant barriers to access to care in areas with a
p.000261: greater shortage of health care providers and health services relative to the national average.
p.000261: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000261: Sec. 330 PUBLIC HEALTH SERVICE ACT 262
p.000261:
p.000261: (e) OPERATING GRANTS.—
p.000261: (1) AUTHORITY.—
p.000261: (A) IN GENERAL.—The Secretary may make grants for the costs of the operation of public and nonprofit
p.000261: private health centers that provide health services to medically underserved populations.
p.000261: (B) ENTITIES THAT FAIL TO MEET CERTAIN REQUIRE- MENTS.—The Secretary may make grants, for a period
p.000261: of not to exceed 1 year, for the costs of the operation of public and nonprofit private entities which provide
p.000261: health serv- ices to medically underserved populations but with respect to which the Secretary is unable to make each
p.000261: of the deter- minations required by subsection (k)(3). The Secretary shall not make a grant under
p.000261: this paragraph unless the applicant provides assurances to the Secretary that within 120 days of receiving grant
p.000261: funding for the operation of the health center, the applicant will submit, for approval by the Secretary, an
p.000261: implementation plan to meet the re- quirements of subsection (k)(3). The Secretary may extend such 120-day period
p.000261: for achieving compliance upon a dem- onstration of good cause by the health center.
p.000261: (C) OPERATION OF NETWORKS.—The Secretary may make grants to health centers that receive
p.000261: assistance under this section, or at the request of the health centers, directly to a network that is at least
p.000261: majority controlled and, as applicable, at least majority owned by such health centers receiving assistance under
p.000261: this section, for the costs associated with the operation of such network includ- ing—
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p.000271: (3) review and comment upon annual program plans and budgets of health centers, including comments upon
p.000271: allocations of health care resources in the State;
p.000271: (4) assist health centers in the development of clinical practices and fiscal and administrative systems
p.000271: through a tech-
p.000271: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000273: PUBLIC HEALTH SERVICE ACT
p.000273: Sec. 330
p.000273:
p.000273: nical assistance plan which is responsive to the requests of health centers; and
p.000273: (5) share information and data relevant to the operation of new and existing health centers.
p.000273: (n) RECORDS.—
p.000273: (1) IN GENERAL.—Each entity which receives a grant under subsection (e) shall establish and maintain such records as
p.000273: the Secretary shall require.
p.000273: (2) AVAILABILITY.—Each entity which is required to estab- lish and maintain records under this subsection shall
p.000273: make such books, documents, papers, and records available to the Secretary or the Comptroller General of
p.000273: the United States, or any of their duly authorized representatives, for examination, copying or mechanical
p.000273: reproduction on or off the premises of such entity upon a reasonable request therefore. The Secretary and the
p.000273: Comptroller General of the United States, or any of their duly authorized representatives, shall have the
p.000273: authority to conduct such examination, copying, and reproduction.
p.000273: (o) DELEGATION OF AUTHORITY.—The Secretary may delegate the authority to administer the programs authorized
p.000273: by this section to any office, except that the authority to enter into, modify, or issue approvals with
p.000273: respect to grants or contracts may be dele- gated only within the central office of the Health
p.000273: Resources and Services Administration.
p.000273: (p) SPECIAL CONSIDERATION.—In making grants under this sec- tion, the Secretary shall give special consideration
p.000273: to the unique needs of sparsely populated rural areas, including giving priority in the awarding of grants for new
p.000273: health centers under subsections (c) and (e), and the granting of waivers as appropriate and permitted under
p.000273: subsections (b)(1)(B)(i) and (k)(3)(G).
p.000273: (q) AUDITS.—
p.000273: (1) IN GENERAL.—Each entity which receives a grant under this section shall provide for an independent annual
p.000273: financial audit of any books, accounts, financial records, files, and other papers and property which relate to
p.000273: the disposition or use of the funds received under such grant and such other funds re- ceived by or
p.000273: allocated to the project for which such grant was made. For purposes of assuring accurate, current, and
p.000273: complete disclosure of the disposition or use of the funds received, each such audit shall be conducted in accordance
p.000273: with generally ac- cepted accounting principles. Each audit shall evaluate—
p.000273: (A) the entity’s implementation of the guidelines es- tablished by the Secretary respecting cost accounting,
p.000273: (B) the processes used by the entity to meet the finan- cial and program reporting requirements of the Secretary, and
p.000273:
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p.000273: January 30, 2020
p.000273: (C) the billing and collection procedures of the entity and the relation of the procedures to its fee
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p.000273:
p.000273: Sec. 330 PUBLIC HEALTH SERVICE ACT 274
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p.000273:
p.000273: (2) RECORDS.—Each entity which receives a grant under this section shall establish and maintain such
p.000273: records as the Secretary shall by regulation require to facilitate the audit re- quired by paragraph (1). The
p.000273: Secretary may specify by regula- tion the form and manner in which such records shall be estab- lished and maintained.
p.000273: (3) AVAILABILITY OF RECORDS.—Each entity which is re- quired to establish and maintain records or to provide for
p.000273: and audit under this subsection shall make such books, documents, papers, and records available to the Secretary
p.000273: or the Comp- troller General of the United States, or any of their duly au- thorized representatives,
p.000273: for examination, copying or mechan- ical reproduction on or off the premises of such entity upon a
p.000273: reasonable request therefore. The Secretary and the Comp- troller General of the United States, or any
p.000273: of their duly au- thorized representatives, shall have the authority to conduct such examination, copying,
p.000273: and reproduction.
p.000273: (4) WAIVER.—The Secretary may, under appropriate cir- cumstances, waive the application of all or part of the
p.000273: require- ments of this subsection with respect to an entity. A waiver provided by the Secretary under
p.000273: this paragraph may not re- main in effect for more than 1 year and may not be extended after such
p.000273: period. An entity may not receive more than one waiver under this paragraph in consecutive years.
p.000273: (r) AUTHORIZATION OF APPROPRIATIONS.—
p.000273: (1) GENERAL AMOUNTS FOR GRANTS.—For the purpose of carrying out this section, in addition to the amounts
p.000273: authorized to be appropriated under subsection (d), there is authorized to be appropriated the following:
p.000273: (A) For fiscal year 2010, $2,988,821,592. (B) For fiscal year 2011, $3,862,107,440. (C) For fiscal year 2012,
p.000273: $4,990,553,440. (D) For fiscal year 2013, $6,448,713,307. (E) For fiscal year 2014, $7,332,924,155. (F) For fiscal year
p.000273: 2015, $8,332,924,155.
p.000273: (G) For fiscal year 2016, and each subsequent fiscal year, the amount appropriated for the preceding fiscal
p.000273: year adjusted by the product of—
p.000273: (i) one plus the average percentage increase in costs incurred per patient served; and
p.000273: (ii) one plus the average percentage increase in the total number of patients served.
p.000273: (2) SPECIAL PROVISIONS.—
p.000273: (A) PUBLIC CENTERS.—The Secretary may not expend in any fiscal year, for grants under this section to
p.000273: public centers (as defined in the second sentence of subsection (k)(3)) the governing boards of which (as
p.000273: described in sub- section (k)(3)(H)) do not establish general policies for such centers, an amount which
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p.000275: this section for that fiscal year, is equal to the proportion of the amount made available under that
p.000275: subsection for fiscal year 2001, relative to the total amount appropriated to carry out this section for fis-
p.000275: cal year 2001.
p.000275: (3) FUNDING REPORT.—The Secretary shall annually pre- pare and submit to the Committee on Health,
p.000275: Education, Labor, and Pensions of the Senate, and the Committee on En- ergy and Commerce of the House of
p.000275: Representatives, a report including, at a minimum—
p.000275: (A) the distribution of funds for carrying out this sec- tion that are provided to meet the health
p.000275: care needs of medically underserved populations, including the home- less, residents of public housing, and
p.000275: migratory and sea- sonal agricultural workers, and the appropriateness of the delivery systems involved in
p.000275: responding to the needs of the particular populations;
p.000275: (B) an assessment of the relative health care access needs of the targeted populations;
p.000275: (C) the distribution of awards and funding for new or expanded services in each of rural areas and urban
p.000275: areas;
p.000275: (D) the distribution of awards and funding for estab- lishing new access points, and the number of new
p.000275: access points created;
p.000275: (E) the amount of unexpended funding for loan guar- antees and loan guarantee authority under title XVI;
p.000275: (F) the rationale for any substantial changes in the distribution of funds;
p.000275: (G) the rate of closures for health centers and access points;
p.000275: (H) the number and reason for any grants awarded pursuant to subsection (e)(1)(B); and
p.000275: (I) the number and reason for any waivers provided pursuant to subsection (q)(4).
p.000275: (4) RULE OF CONSTRUCTION WITH RESPECT TO RURAL HEALTH CLINICS.—
p.000275: (A) IN GENERAL.—Nothing in this section shall be con- strued to prevent a community health center from con-
p.000275: tracting with a Federally certified rural health clinic (as defined in section 1861(aa)(2) of the Social
p.000275: Security Act), a low-volume hospital (as defined for purposes of section 1886 of such Act), a critical access
p.000275: hospital, a sole commu- nity hospital (as defined for purposes of section 1886(d)(5)(D)(iii) of
p.000275: such Act), or a medicare-dependent share hospital (as defined for purposes of section
p.000275: 1886(d)(5)(G)(iv) of such Act) for the delivery of primary health care services that are available at the
p.000275: clinic or hos- pital to individuals who would otherwise be eligible for free or reduced cost care if that
p.000275: individual were able to ob-
p.000275: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000279: (i) REPORT.—Not later than September 30, 2005, the Secretary shall prepare and submit to the appropriate
p.000279: committees of Con- gress a report on the progress and accomplishments of the grant programs described in
p.000279: subsections (e), (f), and (g).
p.000279: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section $45,000,000
p.000279: for each of fiscal years 2008 through 2012.
p.000279: SEC. 330A–1. ø254c–1a¿ GRANTS TO NURSE–MANAGED HEALTH CLINICS.
p.000279: (a) DEFINITIONS.—
p.000279: (1) COMPREHENSIVE PRIMARY HEALTH CARE SERVICES.—In this section, the term ‘‘comprehensive primary health
p.000279: care services’’ means the primary health services described in sec- tion 330(b)(1).
p.000279: (2) NURSE-MANAGED HEALTH CLINIC.—The term ‘‘nurse- managed health clinic’’ means a nurse-practice
p.000279: arrangement, managed by advanced practice nurses, that provides primary care or wellness services to
p.000279: underserved or vulnerable popu- lations and that is associated with a school, college, university or department of
p.000279: nursing, federally qualified health center, or independent nonprofit health or social services agency.
p.000279: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000281: PUBLIC HEALTH SERVICE ACT
p.000281: Sec. 330B
p.000281:
p.000281: (b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants for the cost of the operation of nurse-managed health
p.000281: clinics that meet the requirements of this section.
p.000281: (c) APPLICATIONS.—To be eligible to receive a grant under this section, an entity shall—
p.000281: (1) be an NMHC; and
p.000281: (2) submit to the Secretary an application at such time, in such manner, and containing—
p.000281: (A) assurances that nurses are the major providers of services at the NMHC and that at least 1
p.000281: advanced prac- tice nurse holds an executive management position within the organizational structure of the NMHC;
p.000281: (B) an assurance that the NMHC will continue pro- viding comprehensive primary health care services
p.000281: or wellness services without regard to income or insurance status of the patient for the duration of the
p.000281: grant period; and
p.000281: (C) an assurance that, not later than 90 days of receiv-
p.000281: ing a grant under this section, the NMHC will establish a community advisory committee, for which a majority of the
p.000281: members shall be individuals who are served by the NMHC.
p.000281: (d) GRANT AMOUNT.—The amount of any grant made under this section for any fiscal year shall be
p.000281: determined by the Sec- retary, taking into account—
p.000281: (1) the financial need of the NMHC, considering State, local, and other operational funding provided to
p.000281: the NMHC; and
p.000281: (2) other factors, as the Secretary determines appropriate.
p.000281: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purposes of carrying out this section, there are authorized
p.000281: to be appropriated
p.000281: $50,000,000 for the fiscal year 2010 and such sums as may be nec- essary for each of the fiscal years 2011 through
p.000281: 2014.
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p.000283: in all models of adoption practice and that
p.000283: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000285: PUBLIC HEALTH SERVICE ACT
p.000285: Sec. 330F
p.000285:
p.000285: represent all members of the adoption triad (birth mother, infant, and adoptive parent); and
p.000285: (II) affected public health entities.
p.000285: (ii) DESCRIPTION OF PROCESS.—The process re- ferred to in clause (i) is a process in which the partici- pants
p.000285: described in such clause collaborate to develop best-practices guidelines on the provision of adoption
p.000285: information and referrals to pregnant women on an equal basis with all other courses of action included in
p.000285: nondirective counseling to pregnant women.
p.000285: (iii) DATE CERTAIN FOR DEVELOPMENT.—The Sec- retary shall ensure that the guidelines described in clause
p.000285: (ii) are developed not later than 180 days after the date of the enactment of the Children’s Health Act of 2000 35.
p.000285: (C) RELATION TO AUTHORITY FOR GRANTS.—The Sec- retary may not make any grant under paragraph (1) before the
p.000285: date on which the guidelines under subparagraph (B) are developed.
p.000285: (3) USE OF GRANT.—
p.000285: (A) IN GENERAL.—With respect to a grant under para- graph (1)—
p.000285: (i) an adoption organization may expend the grant to carry out the programs directly or through grants to or
p.000285: contracts with other adoption organizations;
p.000285: (ii) the purposes for which the adoption organiza- tion expends the grant may include the development of
p.000285: a training curriculum, consistent with the guide- lines developed under paragraph (2)(B); and
p.000285: (iii) a condition for the receipt of the grant is that the adoption organization agree that, in providing
p.000285: training for the designated staff of eligible health cen- ters, such organization will make reasonable efforts to
p.000285: ensure that the individuals who provide the training are individuals who are knowledgeable in all elements of
p.000285: the adoption process and are experienced in pro- viding adoption information and referrals in the geo-
p.000285: graphic areas in which the eligible health centers are located, and that the designated staff
p.000285: receive the training in such areas.
p.000285: (B) RULE OF CONSTRUCTION REGARDING TRAINING OF TRAINERS.—With respect to individuals who under a grant under
p.000285: paragraph (1) provide training for the designated staff of eligible health centers (referred to in this subpara-
p.000285: graph as ‘‘trainers’’), subparagraph (A)(iii) may not be con- strued as establishing any limitation regarding the
p.000285: geo- graphic area in which the trainers receive instruction in being such trainers. A trainer may receive such
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p.000287: (A) the barriers to completion of the adoption process;
p.000287: and
p.000287: (B) those components that lead to favorable long-term
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p.000287: January 30, 2020
p.000287: outcomes for families that adopt children with special needs.
p.000287: (d) APPLICATION FOR GRANT.—The Secretary may make an award of a grant or contract under this section
p.000287: only if an applica- tion for the award is submitted to the Secretary and the applica-
p.000287: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: PUBLIC HEALTH SERVICE ACT
p.000289: Sec. 330H
p.000289:
p.000289: tion is in such form, is made in such manner, and contains such agreements, assurances, and information
p.000289: as the Secretary deter- mines to be necessary to carry out this section.
p.000289: (e) FUNDING.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as
p.000289: may be nec- essary for each of the fiscal years 2001 through 2005.
p.000289: SEC. 330H. ø254c–8¿ HEALTHY START FOR INFANTS.
p.000289: (a) IN GENERAL.—
p.000289: (1) CONTINUATION AND EXPANSION OF PROGRAM.—The Sec- retary, acting through the Administrator of the Health
p.000289: Re- sources and Services Administration, Maternal and Child Health Bureau, shall under authority of
p.000289: this section continue in effect the Healthy Start Initiative and may, during fiscal year 2001 and subsequent
p.000289: years, carry out such program on a national basis.
p.000289: (2) DEFINITION.—For purposes of paragraph (1), the term ‘‘Healthy Start Initiative’’ is a reference to
p.000289: the program that, as an initiative to reduce the rate of infant mortality and im- prove perinatal
p.000289: outcomes, makes grants for project areas with high annual rates of infant mortality and that, prior to the ef-
p.000289: fective date of this section, was a demonstration program car- ried out under section 301.
p.000289: (b) CONSIDERATIONS IN MAKING GRANTS.—
p.000289: (1) REQUIREMENTS.—In making grants under subsection (a), the Secretary shall require that applicants (in
p.000289: addition to meeting all eligibility criteria established by the Secretary) es- tablish, for project areas under
p.000289: such subsection, community- based consortia of individuals and organizations (including agencies
p.000289: responsible for administering block grant programs under title V of the Social Security Act, consumers of
p.000289: project services, public health departments, hospitals, health centers under section 330, and other significant
p.000289: sources of health care services) that are appropriate for participation in projects under subsection (a).
p.000289: (2) OTHER CONSIDERATIONS.—In making grants under sub- section (a), the Secretary shall take into consideration
p.000289: the fol- lowing:
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p.000289: Hawaii.
p.000289: (c) COORDINATION.—Recipients of grants under subsection (a) shall coordinate their services and activities with
p.000289: the State agency
p.000289: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000289: Sec. 330I PUBLIC HEALTH SERVICE ACT 290
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p.000289: January 30, 2020
p.000289:
p.000289: or agencies that administer block grant programs under title V of the Social Security Act in order to promote
p.000289: cooperation, integration, and dissemination of information with Statewide systems and with other community services
p.000289: funded under the Maternal and Child Health Block Grant.
p.000289: (d) RULE OF CONSTRUCTION.—Except to the extent inconsistent with this section, this section may not be construed as
p.000289: affecting the authority of the Secretary to make modifications in the program carried out under subsection
p.000289: (a).
p.000289: (e) FUNDING.—
p.000289: (1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized to
p.000289: be appro- priated—
p.000289: (A) $120,000,000 for fiscal year 2008; and
p.000289: (B) for each of fiscal years 2009 through 2013, the amount authorized for the preceding fiscal year
p.000289: increased by the percentage increase in the Consumer Price Index for all urban consumers for such year.
p.000289: (2) ALLOCATION.—
p.000289: (A) PROGRAM ADMINISTRATION.—Of the amounts ap- propriated under paragraph (1) for a fiscal year, the Sec-
p.000289: retary may reserve up to 5 percent for coordination, dis- semination, technical assistance, and data
p.000289: activities that are determined by the Secretary to be appropriate for car- rying out the program under this section.
p.000289: (B) EVALUATION.—Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary may reserve
p.000289: up to 1 percent for evaluations of projects carried out under subsection (a). Each such evaluation shall
p.000289: include a determination of whether such projects have been effective in reducing the disparity in health status between
p.000289: the gen- eral population and individuals who are members of racial or ethnic minority groups.
p.000289: SEC. 330I. ø254c–14¿ TELEHEALTH NETWORK AND TELEHEALTH RE- SOURCE CENTERS GRANT PROGRAMS.
p.000289: (a) DEFINITIONS.—In this section:
p.000289: (1) DIRECTOR; OFFICE.—The terms ‘‘Director’’ and ‘‘Office’’ mean the Director and Office specified in subsection
p.000289: (c).
...

p.000303: (2) In the case of a member of the Corps who is directly en- gaged in the delivery of health
p.000303: services in a health professional shortage area in accordance with a service obligation incurred under the
p.000303: Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may
p.000303: be made for such a member only upon satisfactory completion of such serv- ice obligation, and the first 36
p.000303: months of such member’s being so engaged in the delivery of health services shall, for purposes of
p.000303: paragraph (1)(A), be deemed to begin upon such satisfactory com- pletion.
p.000303: (3) A member of the Corps described in subparagraph (C) of subsection (a)(1) shall when assigned to an entity
p.000303: under section 333 be subject to the personnel system of such entity, except that such member shall receive during
p.000303: the period of assignment the income that the member would receive if the member was a member of the Corps
p.000303: described in subparagraph (B) of such subsection.
p.000303: (e) Corps members assigned under section 333 to provide health services in health professional
p.000303: shortage areas shall not be counted against any employment ceiling affecting the Department.
p.000303: (f) Sections 214 and 216 shall not apply to members of the Na- tional Health Service Corps during their period of
p.000303: obligated service under the Scholarship Program or the Loan Repayment Program, except when such members are
p.000303: Commissioned Corps officers who entered into a contract with Secretary under section 338A or 338B after December
p.000303: 31, 2006 and when the Secretary determines that exercising the authority provided under section 214 or 216 with
p.000303: re- spect to any such officer to would not cause unreasonable disrup-
p.000303: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000303:
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p.000305: 305
p.000305: PUBLIC HEALTH SERVICE ACT
p.000305: Sec. 331
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p.000305: January 30, 2020
p.000305: tion to health care services provided in the community in which such officer is providing health care
p.000305: services.
p.000305: (g)(1) The Secretary shall, by rule, prescribe conversion provi- sions applicable to any individual who, within
p.000305: a year after comple- tion of service as a member of the Corps described in subsection (a)(1)(C), becomes a
p.000305: commissioned officer in the Regular or Reserve Corps of the Service.
...

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p.000339: Sec. 338I PUBLIC HEALTH SERVICE ACT 340
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p.000339: January 30, 2020
p.000339:
p.000339: (c) SCHOLARSHIPS AND LOAN REPAYMENTS.—With respect to certification as a nurse practitioner, nurse
p.000339: midwife, or physician assistant, the Secretary shall, from amounts appropriated under subsection (a) for a
p.000339: fiscal year, obligate not less than a total of 10 percent for contracts for both scholarships under the
p.000339: Scholarship Program under section 338A and loan repayments under the Loan Repayment Program under section 338B to
p.000339: individuals who are en- tering the first year of a course of study or program described in section
p.000339: 338A(b)(1)(B) that leads to such a certification or individ- uals who are eligible for the loan
p.000339: repayment program as specified in section 338B(b) for a loan related to such certification.
p.000339: SEC. 338I. ø254q–1¿ GRANTS TO STATES FOR LOAN REPAYMENT PRO- GRAMS.
p.000339: (a) IN GENERAL.—
p.000339: (1) AUTHORITY FOR GRANTS.—The Secretary, acting through the Administrator of the Health Resources
p.000339: and Serv- ices Administration, may make grants to States for the pur- pose of assisting the States in
p.000339: operating programs described in paragraph (2) in order to provide for the increased availability of primary health care
p.000339: services in health professional shortage areas. The National Advisory Council established under section
p.000339: 337 shall advise the Administrator regarding the program under this section.
p.000339: (2) LOAN REPAYMENT PROGRAMS.—The programs referred to in paragraph (1) are, subject to subsection
p.000339: (c), programs of entering into contracts under which the State involved agrees to pay all or part of
p.000339: the principal, interest, and related ex- penses of the educational loans of health professionals in con-
p.000339: sideration of the professionals agreeing to provide primary health services in health professional shortage
p.000339: areas.
p.000339: (3) DIRECT ADMINISTRATION BY STATE AGENCY.—The Sec- retary may not make a grant under paragraph (1)
p.000339: unless the State involved agrees that the program operated with the grant will be administered directly by a
p.000339: State agency.
p.000339: (b) REQUIREMENT OF MATCHING FUNDS.—
p.000339: (1) IN GENERAL.—The Secretary may not make a grant under subsection (a) unless the State agrees that, with
p.000339: respect to the costs of making payments on behalf of individuals under contracts made pursuant to paragraph (2)
p.000339: of such subsection, the State will make available (directly or through donations from public or private
...

p.000345: require re- garding activities carried out under this section; and
p.000345: (2) to submit such a report or performance data not later than September 30 of each fiscal year
p.000345: immediately following any fiscal year for which the State office of rural health has received such a grant.
p.000345: (g) REQUIREMENT OF APPLICATION.—The Secretary may not make a grant under subsection (a) unless an
p.000345: application for the grant is submitted to the Secretary and the application is in such form, is made in
p.000345: such manner, and contains such agreements, as- surances, and information as the Secretary determines to
p.000345: be nec- essary to carry out such subsection.
p.000345: (h) NONCOMPLIANCE.—The Secretary may not make payments under subsection (a) to a State office of rural
p.000345: health for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines
p.000345: that, for the immediately preceding fiscal year, the State office of rural health has complied with each of the
p.000345: agreements made by the State office of rural health under this sec- tion.
p.000345: (i) AUTHORIZATION OF APPROPRIATIONS.—
p.000345: (1) IN GENERAL.—For the purpose of making grants under subsection (a), there are authorized to be
p.000345: appropriated
p.000345: $12,500,000 for each of fiscal years 2018 through 2022.
p.000345: (2) AVAILABILITY.—Amounts appropriated under paragraph
p.000345: (1) shall remain available until expended.
p.000345: SEC. 338K. ø254s¿ NATIVE HAWAIIAN HEALTH SCHOLARSHIPS.
p.000345: (a) Subject to the availability of funds appropriated under the authority of subsection (d), the Secretary
p.000345: shall provide scholarship
p.000345: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000345:
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p.000345: Sec. 338L PUBLIC HEALTH SERVICE ACT 346
p.000345:
p.000345: assistance, pursuant to a contract with the Papa Ola Lokahi, to students who—
p.000345: (1) meet the requirements of section 338A(b), and
p.000345: (2) are Native Hawaiians.
p.000345: (b)(1) The scholarship assistance provided under subsection (a) shall be provided under the same terms and
p.000345: subject to the same conditions, regulations, and rules that apply to scholarship assist- ance provided under
p.000345: section 338A.
p.000345: (2) The Native Hawaiian Health Scholarship program shall not be administered by or through the Indian Health Service.
p.000345: (c) For purposes of this section, the term ‘‘Native Hawaiian’’ means any individual who is—
p.000345: (1) a citizen of the United States,
p.000345: (2) a resident of the State of Hawaii, and
p.000345: (3) a descendant of the aboriginal people, who prior to 1778, occupied and exercised sovereignty in the area
p.000345: that now constitutes the State of Hawaii, as evidenced by—
p.000345: (A) genealogical records,
p.000345: (B) Kupuna (elders) or Kama’aina (long-term commu- nity residents) verification, or
p.000345: (C) birth records of the State of Hawaii.
...

p.000355: the appropriate committees of Congress a report that describes the extent to which
p.000355: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000355: Sec. 340A PUBLIC HEALTH SERVICE ACT 356
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p.000355: January 30, 2020
p.000355:
p.000355: projects funded under this section have been successful in improv- ing the effectiveness, efficiency, and coordination
p.000355: of services for un- insured and underinsured individuals in the communities or geo- graphic areas served
p.000355: by such projects, including whether the projects resulted in the provision of better quality health
p.000355: care for such individuals, and whether such care was provided at lower costs, than would have been
p.000355: provided in the absence of such projects.
p.000355: (j) DEMONSTRATION AUTHORITY.—The Secretary may make demonstration awards under this section to
p.000355: historically black health professions schools for the purposes of—
p.000355: (1) developing patient-based research infrastructure at his- torically black health professions schools, which have an
p.000355: affili- ation, or affiliations, with any of the providers identified in subsection (b)(1)(B);
p.000355: (2) establishment of joint and collaborative programs of medical research and data collection between
p.000355: historically black health professions schools and such providers, whose goal is to improve the health status of
p.000355: medically underserved popu- lations; or
p.000355: (3) supporting the research-related costs of patient care, data collection, and academic training resulting
p.000355: from such af- filiations.
p.000355: (k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such
p.000355: sums as may be necessary for each of fiscal years 2002 through 2006.
p.000355: (l) DATE CERTAIN FOR TERMINATION OF PROGRAM.—Funds may not be appropriated to carry out this section after
p.000355: September 30, 2006.
p.000355: SEC. 340A. ø256a¿ PATIENT NAVIGATOR GRANTS.
p.000355: (a) GRANTS.—The Secretary, acting through the Administrator of the Health Resources and Services
p.000355: Administration, may make grants to eligible entities for the development and operation of demonstration
p.000355: programs to provide patient navigator services to improve health care outcomes. The Secretary shall coordinate
p.000355: with, and ensure the participation of, the Indian Health Service, the Na- tional Cancer Institute, the Office of Rural
...

p.000367: the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or
p.000367: condition.
p.000367: Subpart VIII—Bulk Purchases of Vaccines for Certain Programs
p.000367: BULK PURCHASES OF VACCINES FOR CERTAIN PROGRAMS
p.000367: SEC. 340C. ø256c¿ (a) AGREEMENTS FOR PURCHASES.—
p.000367: (1) IN GENERAL.—Not later than 180 days after the date of the enactment of the Preventive Health Amendments
p.000367: of 1992 52, the Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention and
p.000367: in consultation with the Administrator of the Health Resources and Services Administration, shall enter into
p.000367: negotiations with manufactur- ers of vaccines for the purpose of establishing and maintaining agreements under which
p.000367: entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in
p.000367: the agreements.
p.000367: (2) RELEVANT ENTITIES.—The entities referred to in para- graph (1) are entities that provide immunizations
p.000367: against vac- cine-preventable diseases with assistance provided under sec- tion 330.
p.000367: (b) NEGOTIATION OF PRICES.—In carrying out subsection (a), the Secretary shall, to the extent practicable,
p.000367: ensure that the prices provided for in agreements under such subsection are comparable to the prices
p.000367: provided for in agreements negotiated by the Sec- retary on behalf of grantees under section 317(j)(1).
p.000367: (c) AUTHORITY OF SECRETARY.—In carrying out subsection (a), the Secretary, in the discretion of the
p.000367: Secretary, may enter into the agreements described in such subsection (and may decline to enter
p.000367:
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p.000367: January 30, 2020
p.000367: 51 Subsection (e) is shown according to the probable intent of Congress. Section 2302(4) of Pub- lic Law 111–152
p.000367: inserts subsection (e) ‘‘after subsection (d)’’. See note in section 340B(d) of the Public Health Service Act regarding
p.000367: the inclusion of subsection (d) to reflect the probable intent of Congress.
p.000367: Section 204(a)(1) of Public Law 111–309 amends subsection (e) of section 340B (effective on the enactment
p.000367: of such Public Law).
p.000367: 52 Enacted October 27, 1992.
p.000367: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000369: 369
p.000369: PUBLIC HEALTH SERVICE ACT
p.000369: Sec. 340D
p.000369:
p.000369: into such agreements), may modify such agreements, may extend such agreements, and may terminate such
p.000369: agreements.
p.000369: (d) RULE OF CONSTRUCTION.—This section may not be con- strued as requiring any State to reduce or terminate the
p.000369: supply of vaccines provided by the State to any of the entities described in subsection (a)(2).
p.000369: BREAST AND CERVICAL CANCER INFORMATION
p.000369: SEC. 340D. ø256d¿ (a) IN GENERAL.—As a condition of receiv- ing grants, cooperative agreements, or
...

p.000383:
p.000383: (D) The number of patients treated by residents de- scribed in paragraph (4).
p.000383: (E) The number of visits by patients treated by resi- dents described in paragraph (4).
p.000383: (F) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents entering primary care practice (meaning any of the areas of practice listed in the
p.000383: definition of a pri- mary care residency program in section 749A).
p.000383: (G) Of the number of residents described in paragraph
p.000383: (4) who completed their residency training at the end of such residency academic year, the number and
p.000383: percentage of such residents who entered practice at a health care fa- cility—
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p.000383: January 30, 2020
p.000383: (i) primarily serving a health professional short- age area with a designation in effect under section 332 or a
p.000383: medically underserved community (as defined in section 799B); or
p.000383: (ii) located in a rural area (as defined in section 1886(d)(2)(D) of the Social Security Act).
p.000383: (H) Other information as deemed appropriate by the Secretary.
p.000383: (2) AUDIT AUTHORITY; LIMITATION ON PAYMENT.—
p.000383: (A) AUDIT AUTHORITY.—The Secretary may audit a qualified teaching health center to ensure the accuracy and
p.000383: completeness of the information submitted in a report under paragraph (1).
p.000383: (B) LIMITATION ON PAYMENT.—A teaching health cen- ter may only receive payment in a cost reporting period for
p.000383: a number of such resident positions that is greater than the base level of primary care resident positions, as
p.000383: deter- mined by the Secretary. For purposes of this subpara- graph, the ‘‘base level of primary care
p.000383: residents’’ for a teaching health center is the level of such residents as of a base period.
p.000383: (3) REDUCTION IN PAYMENT FOR FAILURE TO REPORT.—
p.000383: (A) IN GENERAL.—The amount payable under this sec- tion to a qualified teaching health center for a fiscal
p.000383: year shall be reduced by at least 25 percent if the Secretary de- termines that—
p.000383: (i) the qualified teaching health center has failed to provide the Secretary, as an addendum to the quali- fied
p.000383: teaching health center’s application under this section for such fiscal year, the report required under
p.000383: paragraph (1) for the previous fiscal year; or
p.000383: (ii) such report fails to provide complete and accu- rate information required under any subparagraph of such
p.000383: paragraph.
p.000383: (B) NOTICE AND OPPORTUNITY TO PROVIDE ACCURATE AND MISSING INFORMATION.—Before imposing a reduction
p.000383: under subparagraph (A) on the basis of a qualified teach- ing health center’s failure to provide
p.000383: complete and accu- rate information described in subparagraph (A)(ii), the
p.000383: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000387: manufacture and preparation of any biological product.
p.000387: (d)(1) Upon a determination that a batch, lot, or other quantity of a product licensed under this section
p.000387: presents an imminent or substantial hazard to the public health, the Secretary shall issue an order
p.000387: immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this
p.000387: paragraph shall be issued in accordance with section 554 of title 5, United States Code.
p.000387: (2) Any violation of paragraph (1) shall subject the violator to a civil penalty of up to $100,000 per
p.000387: day of violation. The amount of a civil penalty under this paragraph shall, effective December 1 of each year
p.000387: beginning 1 year after the effective date of this para- graph, be increased by the percent change in the
p.000387: Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base
p.000387: quarter of the preceding year, adjusted to the nearest 1⁄10 of 1 percent. For purposes of this paragraph, the
p.000387: term ‘‘base quarter’’, as used with respect to a year, means the calendar quarter ending on September 30 of such
p.000387: year and the price index for a base quarter is the arithmetical mean of such index for the 3 months
p.000387: comprising such quarter.
p.000387: (e) No person shall interfere with any officer, agent, or em- ployee of the Service in the performance of any
p.000387: duty imposed upon him by this section or by regulations made by authority thereof.
p.000387: (f) Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be
p.000387: punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such
p.000387: fine and imprisonment, in the discretion of the court.
p.000387: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000387:
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p.000389: PUBLIC HEALTH SERVICE ACT
p.000389: Sec. 351
p.000389:
p.000389: (g) Nothing contained in this Act shall be construed as in any way affecting, modifying, repealing, or superseding
p.000389: the provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C., 1940 edition, title 21, ch. 9). 58
p.000389: (h) 59 A partially processed biological product which—
p.000389: (1) is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man;
p.000389: (2) is not intended for sale in the United States; and
p.000389: (3) is intended for further manufacture into final dosage form outside the United States,
p.000389: shall be subject to no restriction on the export of the product under this Act or the Federal Food, Drug, and
p.000389: Cosmetic Act (21 U.S.C. 321 et. seq.) if the product is manufactured, processed, packaged, and held in
p.000389: conformity with current good manufacturing practice requirements or meets international manufacturing
...

p.000391: (5) GENERAL RULES.—
p.000391: (A) ONE REFERENCE PRODUCT PER APPLICATION.—A bi- ological product, in an application submitted under this
p.000391: subsection, may not be evaluated against more than 1 ref- erence product.
p.000391: (B) REVIEW.—An application submitted under this subsection shall be reviewed by the division within
p.000391: the Food and Drug Administration that is responsible for the review and approval of the application under
p.000391: which the reference product is licensed.
p.000391: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000391:
p.000391:
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p.000391: Sec. 351 PUBLIC HEALTH SERVICE ACT 392
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p.000391: January 30, 2020
p.000391:
p.000391: (C) RISK EVALUATION AND MITIGATION STRATEGIES.— The authority of the Secretary with respect to risk evalua-
p.000391: tion and mitigation strategies under the Federal Food, Drug, and Cosmetic Act shall apply to biological
p.000391: products licensed under this subsection in the same manner as such authority applies to biological products licensed
p.000391: under sub- section (a).
p.000391: (6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE BIOLOGICAL PRODUCT.—Upon review of an application submitted under this
p.000391: subsection relying on the same reference product for which a prior biological product has received a
p.000391: determination of inter- changeability for any condition of use, the Secretary shall not make a
p.000391: determination under paragraph (4) that the second or subsequent biological product is interchangeable for any
p.000391: condi- tion of use until the earlier of—
p.000391: (A) 1 year after the first commercial marketing of the first interchangeable biosimilar biological product to be ap-
p.000391: proved as interchangeable for that reference product;
p.000391: (B) 18 months after—
p.000391: (i) a final court decision on all patents in suit in an action instituted under subsection (l)(6) against the
p.000391: applicant that submitted the application for the first approved interchangeable biosimilar biological prod-
p.000391: uct; or
p.000391: (ii) the dismissal with or without prejudice of an action instituted under subsection (l)(6) against the
p.000391: applicant that submitted the application for the first approved interchangeable biosimilar biological prod-
p.000391: uct; or
p.000391: (C)(i) 42 months after approval of the first inter- changeable biosimilar biological product if
p.000391: the applicant that submitted such application has been sued under sub- section (l)(6) and such litigation is
p.000391: still ongoing within such 42-month period; or
p.000391: (ii) 18 months after approval of the first interchange- able biosimilar biological product if the applicant
p.000391: that sub- mitted such application has not been sued under sub- section (l)(6).
...

p.000405: security or an investigation by any law enforcement agency shall be subject to the processes set forth in
p.000405: subparagraphs (A) and (B)(i) of section 2339B(f)(5) of title 18, United States Code (re- lating to interlocutory
p.000405: appeal and expedited consider- ation).
p.000405: (ii) DISCLOSURE OF INFORMATION.—In a review under subparagraph (A), and in any judical proceeding conducted
p.000405: pursuant to such review, neither the Sec- retary nor the Attorney General may be required to disclose to
p.000405: the public any information that under sub- section (h) shall not be disclosed under section 552 of title 5,
p.000405: United States Code.
p.000405: (8) NOTIFICATIONS REGARDING THEFT OR LOSS OF AGENTS.— Requirements under paragraph (1) shall include the
p.000405: prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the
p.000405: theft or loss of listed agents and toxins.
p.000405: (9) TECHNICAL ASSISTANCE FOR REGISTERED PERSONS.—The Secretary, in consultation with the Attorney General, may pro-
p.000405: vide technical assistance to registered persons to improve secu- rity of the facilities of such persons.
p.000405: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000405:
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p.000407: 407
p.000407: PUBLIC HEALTH SERVICE ACT
p.000407: Sec. 351A
p.000407:
p.000407: (f) INSPECTIONS.—The Secretary shall have the authority to in- spect persons subject to regulations under
p.000407: subsection (b) or (c) to ensure their compliance with such regulations, including prohibi- tions on
p.000407: restricted persons and other provisions of subsection (e).
p.000407: (g) EXEMPTIONS.—
p.000407: (1) CLINICAL OR DIAGNOSTIC LABORATORIES.—Regulations under subsections (b) and (c) shall exempt clinical or
p.000407: diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are
p.000407: contained in specimens pre- sented for diagnosis, verification, or proficiency testing, pro- vided that—
p.000407: (A) the identification of such agents or toxins is re- ported to the Secretary, and when required under
p.000407: Federal,
p.000407: State, or local law, to other appropriate authorities; and
p.000407: (B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.
p.000407: (2) PRODUCTS.—
p.000407: (A) IN GENERAL.—Regulations under subsections (b) and (c) shall exempt products that are, bear, or
p.000407: contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts
p.000407: specified in subpara- graph (B), unless the Secretary by order determines that applying additional
p.000407: regulation under subsection (b) or (c) to a specific product is necessary to protect public health and
p.000407: safety.
p.000407: (B) RELEVANT LAWS.—For purposes of subparagraph (A), the Acts specified in this subparagraph are the fol-
p.000407: lowing:
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p.000409: under subsection (f) that identifies the listed agent or toxin pos- sessed by a specific registered person or
p.000409: that discloses the identity or location of a specific registered person if the agency determines that
p.000409: public disclosure of the informa- tion would endanger public health or safety.
p.000409: (2) COVERED AGENCIES.—For purposes of paragraph (1) only, the Federal agencies specified in this paragraph
p.000409: are the following:
p.000409: (A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and
p.000409: the Department of Transportation.
p.000409: (B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified
p.000409: in subparagraph (A) of this paragraph.
p.000409: (C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.
p.000409: (D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving
p.000409: listed agents and toxins to or with a registered person, and to which information specified in paragraph (1)
p.000409: is transferred by any such registered person.
p.000409: (3) OTHER EXEMPTIONS.—This subsection may not be con- strued as altering the application of any
p.000409: exemptions to public disclosure under section 552 of title 5, United States Code, ex- cept as to subsection 552(b)(3)
p.000409: of such title, to any of the infor- mation specified in paragraph (1).
p.000409: (4) RULE OF CONSTRUCTION.—Except as specifically pro- vided in paragraph (1), this subsection may not be
p.000409: construed as altering the authority of any Federal agency to withhold under section 552 of title 5, United
p.000409: States Code, or the obliga- tion of any Federal agency to disclose under section 552 of title 5, United States Code,
p.000409: any information, including information relating to—
p.000409: (A) listed agents and toxins, or individuals seeking ac- cess to such agents and toxins;
p.000409: (B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and
p.000409: toxins;
p.000409: (C) general safeguard and security policies and re- quirements under regulations under subsections (b) and
p.000409: (c); or
p.000409: (D) summary or statistical information concerning reg- istrations, registrants, denials or revocations of
p.000409: registra- tions, listed agents and toxins, inspection evaluations and reports, or individuals seeking access
p.000409: to such agents and toxins.
p.000409: (5) DISCLOSURES TO CONGRESS; OTHER DISCLOSURES.—This subsection may not be construed as providing any
p.000409: authority—
p.000409: (A) to withhold information from the Congress or any committee or subcommittee thereof; or
p.000409: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000409: Sec. 351A PUBLIC HEALTH SERVICE ACT 410
p.000409:
p.000409: (B) to withhold information from any person under any other Federal law or treaty.
p.000409: (i) CIVIL MONEY PENALTY.— 61
p.000409: (1) IN GENERAL.—In addition to any other penalties that may apply under law, any person who violates
p.000409: any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money
p.000409: penalty in an amount not ex- ceeding $250,000 in the case of an individual and $500,000 in the case of
p.000409: any other person.
p.000409: (2) APPLICABILITY OF CERTAIN PROVISIONS.—The provisions of section 1128A of the Social Security Act (other
p.000409: than sub- sections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of
p.000409: subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such
p.000409: provisions apply to a penalty or proceeding under sec- tion 1128A(a) of such Act. The Secretary may delegate author-
p.000409: ity under this subsection in the same manner as provided in section 1128A(j)(2) of the Social Security Act,
p.000409: and such author- ity shall include all powers as contained in section 6 of the In- spector General Act of 1978 (5
p.000409: U.S.C. App.).
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p.000431: January 30, 2020
p.000431: (H) standards relating to special techniques for mam- mography of patients with breast implants.
p.000431: Subparagraph (G) shall not be construed to limit a patient’s ac- cess to the patient’s medical records.
p.000431: (2) CERTIFICATION OF PERSONNEL.—The Secretary shall by regulation—
p.000431: (A) specify organizations eligible to certify individuals to perform radiological procedures as required by
p.000431: para- graph (1)(C);
p.000431: (B) specify boards eligible to certify physicians to in- terpret radiological procedures, including
p.000431: mammography, as required by paragraph (1)(D);
p.000431: (C) establish standards for a program to certify physi- cians described in paragraph (1)(D); and
p.000431: (D) specify boards eligible to certify medical physicists who are qualified to survey mammography equipment and to
p.000431: oversee quality assurance practices at mammography facilities.
p.000431: (g) INSPECTIONS.—
p.000431: (1) ANNUAL INSPECTIONS.—
p.000431: (A) IN GENERAL.—The Secretary may enter and in- spect facilities to determine compliance with the
p.000431: certifi- cation requirements under subsection (b) and the stand- ards established under subsection (f). The
p.000431: Secretary shall, if feasible, delegate to a State or local agency the authority to make such inspections.
p.000431: (B) IDENTIFICATION.—The Secretary, or State or local agency acting on behalf of the Secretary, may
p.000431: conduct in- spections only on presenting identification to the owner, operator, or agent in charge of the
p.000431: facility to be inspected.
p.000431: (C) SCOPE OF INSPECTION.—In conducting inspections, the Secretary or State or local agency acting on
p.000431: behalf of the Secretary—
p.000431: (i) shall have access to all equipment, materials, records, and information that the Secretary or State or local
p.000431: agency considers necessary to determine whether the facility is being operated in accordance with this section;
p.000431: and
p.000431: (ii) may copy, or require the facility to submit to the Secretary or the State or local agency, any
p.000431: of the materials, records, or information.
p.000431: (D) QUALIFICATIONS OF INSPECTORS.—Qualified indi- viduals, as determined by the Secretary, shall conduct
p.000431: all inspections. The Secretary may request that a State or local agency acting on behalf of the
p.000431: Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal
p.000431: officer or employee to con- duct inspections. The Secretary shall establish minimum qualifications and
p.000431: appropriate training for inspectors and criteria for certification of inspectors in order to inspect fa- cilities
p.000431: for compliance with subsection (f).
p.000431: (E) FREQUENCY.—The Secretary or State or local agen- cy acting on behalf of the Secretary shall conduct
p.000431: inspec-
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p.000431: (F) RECORDS AND ANNUAL REPORTS.—The Secretary or a State or local agency acting on behalf of the Secretary
p.000431: which is responsible for inspecting mammography facilities shall maintain records of annual inspections
p.000431: required under this paragraph for a period as prescribed by the Sec- retary. Such a State or local agency shall
p.000431: annually prepare and submit to the Secretary a report concerning the in- spections carried out under this
p.000431: paragraph. Such reports shall include a description of the facilities inspected and the results of such
p.000431: inspections.
p.000431: (2) INSPECTION OF ACCREDITED FACILITIES.—The Secretary shall inspect annually a sufficient number of the
p.000431: facilities ac- credited by an accreditation body to provide the Secretary with a reasonable estimate of the
p.000431: performance of such body.
p.000431: (3) INSPECTION OF FACILITIES INSPECTED BY STATE OR LOCAL AGENCIES.—The Secretary shall inspect
p.000431: annually facili- ties inspected by State or local agencies acting on behalf of the Secretary to assure a reasonable
p.000431: performance by such State or local agencies.
p.000431: (4) TIMING.—The Secretary, or State or local agency, may conduct inspections under paragraphs (1), (2),
p.000431: and (3), during regular business hours or at a mutually agreeable time and after providing such notice as
p.000431: the Secretary may prescribe, ex- cept that the Secretary may waive such requirements if the continued
p.000431: performance of mammography at such facility threatens the public health.
p.000431: (5) LIMITED REINSPECTION.—Nothing in this section limits the authority of the Secretary to conduct limited
p.000431: reinspections of facilities found not to be in compliance with this section.
p.000431: (6) DEMONSTRATION PROGRAM.—
p.000431: (A) IN GENERAL.—The Secretary may establish a dem- onstration program under which inspections under para- graph
p.000431: (1) of selected facilities are conducted less frequently by the Secretary (or as applicable, by State or local
p.000431: agen- cies acting on behalf of the Secretary) than the interval specified in subparagraph (E) of such
p.000431: paragraph.
p.000431: (B) REQUIREMENTS.—Any demonstration program under subparagraph (A) shall be carried out in accordance with the
p.000431: following:
p.000431: (i) The program may not be implemented before April 1, 2001. Preparations for the program may be carried
p.000431: out prior to such date.
p.000431: (ii) In carrying out the program, the Secretary may not select a facility for inclusion in the program
p.000431: unless the facility is substantially free of incidents of noncompliance with the standards under
p.000431: subsection (f). The Secretary may at any time provide that a facil- ity will no longer be included in the program.
p.000431: (iii) The number of facilities selected for inclusion in the program shall be sufficient to provide a statis-
p.000431: tically significant sample, subject to compliance with clause (ii).
p.000431: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000433: PUBLIC HEALTH SERVICE ACT
p.000433: Sec. 354
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p.000435: or kick- backs;
p.000435: (B) that have been subject to sanctions under sub- section (h), together with a statement of the
p.000435: reasons for the sanctions;
p.000435: (C) that have had certificates revoked or suspended under subsection (i), together with a statement of the rea-
p.000435: sons for the revocation or suspension;
p.000435: (D) against which the Secretary has taken action under subsection (j), together with a statement of the
p.000435: rea- sons for the action;
p.000435: (E) whose accreditation has been revoked, together with a statement of the reasons of the revocation;
p.000435: (F) against which a State has taken adverse action;
p.000435: and
p.000435: (G) that meets such other measures of performance as
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p.000435: January 30, 2020
p.000435: the Secretary may develop.
p.000435: (2) DATE.—The information to be compiled under para- graph (1) shall be information for the calendar
p.000435: year preceding the date the information is to be made available to the public.
p.000435: (3) EXPLANATORY INFORMATION.—The information to be compiled under paragraph (1) shall be accompanied by such
p.000435: ex- planatory information as may be appropriate to assist in the interpretation of the information
p.000435: compiled under such para- graph.
p.000435: (m) STATE LAWS.—Nothing in this section shall be construed to limit the authority of any State to enact and enforce
p.000435: laws relating to the matters covered by this section that are at least as stringent as this section or the regulations
p.000435: issued under this section.
p.000435: (n) NATIONAL ADVISORY COMMITTEE.—
p.000435: (1) ESTABLISHMENT.—In carrying out this section, the Sec- retary shall establish an advisory committee to be
p.000435: known as the National Mammography Quality Assurance Advisory Com- mittee (hereafter in this subsection referred to as
p.000435: the ‘‘Advisory Committee’’).
p.000435: (2) COMPOSITION.—The Advisory Committee shall be com- posed of not fewer than 13, nor more than 19 individuals,
p.000435: who are not officers or employees of the Federal Government. The Secretary shall make appointments to the
p.000435: Advisory Committee from among—
p.000435: (A) physicians,
p.000435: (B) practitioners, and
p.000435: (C) other health professionals,
p.000435: whose clinical practice, research specialization, or professional expertise include a significant focus on
p.000435: mammography. The Secretary shall appoint at least 4 individuals from among na- tional breast cancer or
p.000435: consumer health organizations with ex- pertise in mammography, at least 2 industry representatives with
p.000435: expertise in mammography equipment, and at least 2 practicing physicians who provide mammography services.
p.000435: (3) FUNCTIONS AND DUTIES.—The Advisory Committee shall—
p.000435: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000437: (c), (d), (g)(1), (h), (i), and (j) (including the requirements under regulations promulgated pursuant to
p.000437: such subsections), and
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p.000439: PUBLIC HEALTH SERVICE ACT
p.000439: Sec. 354
p.000439:
p.000439: (B) to implement the standards established by the Sec- retary under subsection (f),
p.000439: with respect to mammography facilities operating within the State.
p.000439: (2) APPROVAL.—The Secretary may approve an application under paragraph (1) if the Secretary determines that—
p.000439: (A) the State has enacted laws and issued regulations relating to mammography facilities which are the require- ments
p.000439: of this section (including the requirements under regulations promulgated pursuant to such subsections), and
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p.000439: (B) the State has provided satisfactory assurances that the State—
p.000439: (i) has the legal authority and qualified personnel necessary to enforce the requirements of and the regu- lations
p.000439: promulgated pursuant to this section (includ- ing the requirements under regulations promulgated pursuant to
p.000439: such subsections),
p.000439: (ii) will devote adequate funds to the administra- tion and enforcement of such requirements, and
p.000439: (iii) will provide the Secretary with such informa- tion and reports as the Secretary may require.
p.000439: (3) AUTHORITY OF SECRETARY.—In a State with an ap- proved application—
p.000439: (A) the Secretary shall carry out the Secretary’s func- tions under subsections (e) and (f);
p.000439: (B) the Secretary may take action under subsections (h), (i), and (j); and
p.000439: (C) the Secretary shall conduct oversight functions under subsections (g)(2) and (g)(3).
p.000439: (4) WITHDRAWAL OF APPROVAL.—
p.000439: (A) IN GENERAL.—The Secretary may, after providing notice and opportunity for corrective action, withdraw
p.000439: the approval of a State’s authority under paragraph (1) if the Secretary determines that the State does not
p.000439: meet the re- quirements of such paragraph. The Secretary shall pro- mulgate regulations for the
p.000439: implementation of this sub- paragraph.
p.000439: (B) EFFECT OF WITHDRAWAL.—If the Secretary with- draws the approval of a State under subparagraph (A), the
p.000439: certificate of any facility certified by the State shall con- tinue in effect until the expiration of a
p.000439: reasonable period, as determined by the Secretary, for such facility to obtain certification by the Secretary.
p.000439: (r) FUNDING.—
p.000439: (1) FEES.—
p.000439: (A) IN GENERAL.—The Secretary shall, in accordance with this paragraph assess and collect fees from
p.000439: persons described in subsection (d)(1)(A) (other than persons who are governmental entities, as determined by
p.000439: the Secretary) to cover the costs of inspections conducted under sub- section (g)(1) by the Secretary or
p.000439: a State acting under a delegation under subparagraph (A) of such subsection. Fees may be assessed
p.000439: and collected under this paragraph
p.000439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000439:
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p.000439:
p.000439: Sec. 361 PUBLIC HEALTH SERVICE ACT 440
p.000439:
p.000439: only in such manner as would result in an aggregate amount of fees collected during any fiscal
...

p.000441: (d)(1) Regulations prescribed under this section may provide for the apprehension and examination of any
p.000441: individual reasonably believed to be infected with a communicable disease in a qualifying stage and (A) to be
p.000441: moving or about to move from a State to an- other State; or (B) to be a probable source of infection
p.000441: to individ- uals who, while infected with such disease in a qualifying stage, will be moving from a State
p.000441: to another State. Such regulations may provide that if upon examination any such individual is found to be
p.000441: infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of
p.000441: this subsection, the term ‘‘State’’ includes, in addition to the several States, only the District of
p.000441: Columbia.
p.000441: (2) For purposes of this subsection, the term ‘‘qualifying stage’’, with respect to a communicable disease, means that
p.000441: such disease—
p.000441: (A) is in a communicable stage; or
p.000441: (B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if
p.000441: transmitted to other individuals.
p.000441: (e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be
p.000441: construed as superseding any provision under State law (including regulations and including provisions established by
p.000441: political subdivisions of States), except to the extent that such a provision conflicts with an exercise of
p.000441: Fed- eral authority under this section or section 363.
p.000441: SUSPENSION OF ENTRIES AND IMPORTS FROM DESIGNATED PLACES
p.000441: SEC. 362. ø265¿ Whenever the Surgeon General determines that by reason of the existence of any
p.000441: communicable disease in a foreign country there is serious danger of the introduction of such disease into
p.000441: the United States, and that this danger is so increased by the introduction of persons or property from such
p.000441: country that a suspension of the right to introduce such persons and property is required in the
p.000441: interest of the public health, the Surgeon Gen- eral, in accordance with regulations approved by the
p.000441: President, shall have the power to prohibit, in whole or in part, the introduc- tion of persons and property from
p.000441: such countries or places as he shall designate in order to avert such danger, and for such period of
p.000441: time as he may deem necessary for such purpose.
p.000441: SPECIAL POWERS IN TIME OF WAR
p.000441: SEC. 363. 73 ø266¿ To protect the military and naval forces and war workers of the United States, in time of war,
p.000441: against any com- municable disease specified in Executive orders as provided in sub- section (b) of section 361,
p.000441: the Secretary, in consultation with the Surgeon General, is authorized to provide by regulations for the ap-
p.000441: prehension and examination, in time of war, of any individual rea- sonably believed (1) to be infected with such
...

p.000445: PENALTIES
p.000445: SEC. 368. ø271¿ (a) Any person who violates any regulation prescribed under section 361, 362, or 363,
p.000445: or any provision of sec- tion 366 or any regulation prescribed thereunder, or who enters or departs from the
p.000445: limits of any quarantine station, ground, or an- chorage in disregard of quarantine rules and regulations or
p.000445: without permission of the quarantine officer in charge, shall be punished by a fine of not more than $1,000 or
p.000445: by imprisonment for not more than one year, or both.
p.000445: (b) Any vessel which violates section 366, or any regulations thereunder or under section 364, or which enters
p.000445: within or departs from the limits of any quarantine station, ground, or anchorage in disregard of the quarantine
p.000445: rules and regulations or without per- mission of the officer in charge, shall forfeit to the United
p.000445: States not more than $5,000, the amount to be determined by the court, which shall be a lien on such vessel,
p.000445: to be recovered by proceedings in the proper district court of the United States. In all such pro- ceedings
p.000445: the United States attorney shall appear on behalf of the United States; and all such proceedings shall
p.000445: be conducted in ac- cordance with the rules and laws governing cases of seizure of ves- sels for violation of the
p.000445: revenue laws of the United States.
p.000445: (c) With the approval of the Secretary, the Surgeon General may, upon application therefor, remit or
p.000445: mitigate any forfeiture provided for under subsection (b) of this section, and he shall have authority to ascertain
p.000445: the facts upon all such applications.
p.000445: ADMINISTRATION OF OATHS
p.000445: SEC. 369. ø272¿ Medical officers of the United States, when performing duties as quarantine officers at any
p.000445: port or place within the United States, are authorized to take declarations and admin- ister oaths in matters
p.000445: pertaining to the administration of the quar- antine laws and regulations of the United States.
p.000445: PART H—ORGAN TRANSPLANTS 75
p.000445: ORGAN PROCUREMENT ORGANIZATIONS
p.000445: SEC. 371. ø273¿ (a)(1) The Secretary may make grants for the planning of qualified organ procurement organizations
p.000445: described in subsection (b).
p.000445:
p.000445: 75 Section 301 of the National Organ Transplant Act (Public Law 98–507; 42 U.S.C. 274e) pro- vides:
p.000445:
p.000445:
p.000445: January 30, 2020
p.000445: Continued
p.000445: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000445:
p.000445:
p.000445:
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p.000445:
p.000445: Sec. 371 PUBLIC HEALTH SERVICE ACT 446
p.000445:
p.000445: (2) The Secretary may make grants for the establishment, ini- tial operation, consolidation, and expansion of
p.000445: qualified organ pro- curement organizations described in subsection (b).
p.000445: (b)(1) 76 A qualified organ procurement organization for which grants may be made under subsection (a) is an
p.000445: organization which, as determined by the Secretary, will carry out the functions de- scribed in paragraph (2)
p.000445: 77 and—
p.000445: (A) is a nonprofit entity,
...

p.000447: substantive and procedural grounds;
p.000447: (E) has procedures to obtain payment for non-renal organs provided to transplant centers,
p.000447: (F) has a defined service area that is of sufficient size to assure maximum effectiveness in the
p.000447: procurement and equi- table distribution of organs, and that either includes an entire metropolitan statistical area
p.000447: (as specified by the Director of the Office of Management and Budget) or does not include any part of the
p.000447: area,
p.000447: (G) has a director and such other staff, including the organ donation coordinators and organ procurement
p.000447: specialists nec- essary to effectively obtain organs from donors in its service area, and
p.000447: (H) has a board of directors or an advisory board which—
p.000447: (i) is composed of—
p.000447: (I) members who represent hospital administra- tors, intensive care or emergency room personnel, tis- sue
p.000447: banks, and voluntary health associations in its service area,
p.000447: (II) members who represent the public residing in such area,
p.000447: (III) a physician with knowledge, experience, or skill in the field of histocompatability 78 or an indi-
p.000447: vidual with a doctorate degree in a biological science with knowledge, experience, or skill in the field
p.000447: of histocompatibility,
p.000447: (IV) a physician with knowledge or skill in the field of neurology, and
p.000447: (V) from each transplant center in its service area which has arrangements described in paragraph (3)(G) with the
p.000447: organization, a member who is a surgeon who has practicing privileges in such center and who per- forms organ
p.000447: transplant surgery,
p.000447: (ii) has the authority to recommend policies for the procurement of organs and the other functions described in
p.000447: paragraph (3), and
p.000447: (iii) has no authority over any other activity of the or- ganization.
p.000447: (2)(A) Not later than 90 days after the date of the enactment of this paragraph, 80 the Secretary shall
p.000447: publish in the Federal Reg- ister a notice of proposed rulemaking to establish criteria for deter-
p.000447:
p.000447:
p.000447:
p.000447:
p.000447: January 30, 2020
p.000447: 78 So in law. Probably should be ‘‘histocompatibility’’.
p.000447: 79 So in law. Probably should be paragraph (3).
p.000447: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000447:
p.000447:
p.000447:
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p.000447:
p.000447: Sec. 371A PUBLIC HEALTH SERVICE ACT 448
p.000447:
p.000447: mining whether an entity meets the requirement established in paragraph (1)(E).
p.000447: (B) Not later than 1 year after the date of enactment of this paragraph, 80 the Secretary shall publish in
p.000447: the Federal Register a final rule to establish the criteria described in subparagraph (A).
p.000447: (3) An organ procurement organization shall—
p.000447: (A) have effective agreements, to identify potential organ donors, with a substantial majority of the
p.000447: hospitals and other health care entities in its service area which have facilities for organ donations,
p.000447: (B) conduct and participate in systematic efforts, including professional education, to acquire all usable organs from
p.000447: poten- tial donors,
p.000447: (C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of
...

p.000453: in other States.
p.000453: (3) USE OF FUNDS.—Funds received under this subsection may be used by the State, or in partnership with other
p.000453: public agencies or private sector institutions, for education and awareness efforts, information
p.000453: dissemination, activities per- taining to the State donor registry, and other innovative dona- tion specific
p.000453: initiatives, including living donation.
p.000453: (d) EDUCATIONAL ACTIVITIES.—The Secretary, in coordination with the Organ Procurement and Transplantation
p.000453: Network and other appropriate organizations, shall support the development and dissemination of educational
p.000453: materials to inform health care pro- fessionals and other appropriate professionals in issues sur-
p.000453: rounding organ, tissue, and eye donation including evidence-based proven methods to approach patients and
p.000453: their families, cultural sensitivities, and other relevant issues.
p.000453: (e) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000453: to be appropriated
p.000453: $15,000,000 for fiscal year 2005, and such sums as may be nec- essary for each of the fiscal years 2006
p.000453: through 2009. Such author- ization of appropriations is in addition to any other authorizations of appropriations that
p.000453: are available for such purpose.
p.000453: SEC. 377B. ø274f–2¿ GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.
p.000453: (a) AUTHORITY.—
p.000453: (1) IN GENERAL.—The Secretary may award grants to qualified organ procurement organizations and hospitals
p.000453: under section 371 to establish programs coordinating organ donation activities of eligible hospitals and
p.000453: qualified organ procurement organizations under section 371. Such activities shall be coordi- nated to increase the
p.000453: rate of organ donations for such hos- pitals.
p.000453: (2) ELIGIBLE HOSPITAL.—For purposes of this section, the term ‘‘eligible hospital’’ means a hospital that
p.000453: performs signifi- cant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer
p.000453: than 200,000 individuals.
p.000453: (b) ADMINISTRATION OF COORDINATION PROGRAM.—A condition for the receipt of a grant under subsection (a) is that
p.000453: the applicant involved agree that the program under such subsection will be car- ried out jointly—
p.000453: (1) by representatives from the eligible hospital and the qualified organ procurement organization with
p.000453: respect to which the grant is made; and
p.000453: (2) by such other entities as the representatives referred to in paragraph (1) may designate.
p.000453: (c) REQUIREMENTS.—Each entity receiving a grant under sub- section (a) shall—
p.000453: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000453:
p.000453:
p.000453:
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p.000455: 455
p.000455: PUBLIC HEALTH SERVICE ACT
p.000455: Sec. 377C
p.000455:
...

p.000483: (c) ELIGIBILITY.—To be eligible to receive a cooperative agree- ment under this section, an eligible
p.000483: entity (pursuant to subsection (a)) shall prepare and submit to the Secretary an application at such time,
p.000483: in such manner, and containing such information as the Secretary may require, including a plan that describes—
p.000483: (1) how the applicant proposes to develop or expand, pro- grams to educate individuals through partnership
p.000483: engagement, workforce development, guidance and support for pro- grammatic efforts, and evaluation
p.000483: with respect to Alzheimer’s disease and related dementias, and in the case of a cooperative agreement under this
p.000483: section, how the applicant proposes to support other relevant activities identified by the Secretary or Director
p.000483: of the Centers for Disease Control and Prevention, as appropriate.
p.000483: (2) the manner in which the applicant will coordinate with Federal, tribal, and State programs related to Alzheimer’s
p.000483: dis- ease and related dementias, and appropriate State, tribal, and local agencies, as well as other relevant public
p.000483: and private or- ganizations or agencies; and
p.000483: (3) the manner in which the applicant will evaluate the ef- fectiveness of any program carried out under the
p.000483: cooperative agreement.
p.000483: (d) MATCHING REQUIREMENT.—Each health department that is awarded a cooperative agreement under subsection (a)
p.000483: shall pro- vide, from non-Federal sources, an amount equal to 30 percent of the amount provided under
p.000483: such agreement (which may be pro- vided in cash or in-kind) to carry out the activities supported by
p.000483: the cooperative agreement.
p.000483: (e) WAIVER AUTHORITY.—The Secretary may waive all or part of the matching requirement described in
p.000483: subsection (d) for any fis- cal year for a health department of a State, political subdivision of a State, or Indian
p.000483: tribe and tribal organization (including those lo- cated in a rural area or frontier area), if the Secretary determines
p.000483: that applying such matching requirement would result in serious hardship or an inability to carry out
p.000483: the purposes of the coopera- tive agreement awarded to such health department of a State, po- litical
p.000483: subdivision of a State, or Indian tribe and tribal organiza- tion.
p.000483: (g) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a
p.000483: grant 92 under subsection (a) for any item or service to the extent that payment
p.000483:
p.000483:
p.000483:
p.000483:
p.000483: January 30, 2020
p.000483: 92 Section 3(6) of Public Law 115–406 provides as follows: ‘‘(6) in subsection (f) (as so redesig- nated), by striking
p.000483: ‘grant’ and inserting ‘cooperative agreement’ ’’. The amendment was not car- ried out because it probably should have
p.000483: been made to subsection (g) (as so redesignated).
p.000483: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000483:
p.000483:
p.000483:
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p.000483:
p.000483: Sec. 398A PUBLIC HEALTH SERVICE ACT 484
p.000483:
...

p.000515: shall carry out the fol- lowing functions:
p.000515: (1) Hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of
p.000515: the offi- cers and employees.
p.000515: (2) Accept and administer donations to the Foundation, and administer the assets of the Foundation.
p.000515: (3) Establish a process for the selection of candidates for holding endowed positions under subsection (c).
p.000515: (4) Enter into such financial agreements as are appro- priate in carrying out the activities of the Foundation.
p.000515: (5) Take such action as may be necessary to acquire pat- ents and licenses for devices and procedures
p.000515: developed by the Foundation and the employees of the Foundation.
p.000515: (6) Adopt, alter, and use a corporate seal, which shall be judicially noticed.
p.000515: (7) Commence and respond to judicial proceedings in the name of the Foundation.
p.000515: (8) Other functions that are appropriate in the determina- tion of the Director.
p.000515: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000515:
p.000515:
p.000515:
p.000515:
p.000515:
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p.000515:
p.000515:
p.000517: 517
p.000517: PUBLIC HEALTH SERVICE ACT
p.000517: Sec. 399G
p.000517:
p.000517: (h) GENERAL PROVISIONS.—
p.000517: (1) AUTHORITY FOR ACCEPTING FUNDS.—The Director of the Centers for Disease Control and Prevention may accept
p.000517: and utilize, on behalf of the Federal Government, any gift, dona- tion, bequest, or devise of real or
p.000517: personal property from the Foundation for the purpose of aiding or facilitating the work of such Centers. Funds may
p.000517: be accepted and utilized by such Di- rector under the preceding sentence without regard to whether the funds are
p.000517: designated as general-purpose funds or special- purpose funds.
p.000517: (2) AUTHORITY FOR ACCEPTANCE OF VOLUNTARY SERV- ICES.—
p.000517:
p.000517:
p.000517:
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p.000517:
p.000517: January 30, 2020
p.000517: (A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal
p.000517: Gov- ernment, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or
p.000517: facilitating the work of such Centers. In the case of an individual, such Director may accept the
p.000517: services provided under the preceding sentence by the individual until such time as the private funding for such
p.000517: individual ends.
p.000517: (B) The limitation established in subparagraph (A) re- garding the period of time in which services may be
p.000517: ac- cepted applies to each individual who is not an employee of the Federal Government and who serves
p.000517: in association with the Centers for Disease Control and Prevention pur- suant to financial support from the
p.000517: Foundation.
p.000517: (3) ADMINISTRATIVE CONTROL.—No officer, employee, or member of the Board of the Foundation may
p.000517: exercise any ad- ministrative or managerial control over any Federal employee.
p.000517: (4) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL EMPLOYEES.—In the case of any individual who is not
...

p.000517: activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal
p.000517: year involved a com- prehensive statement of the operations, activities, financial condition, and accomplishments of
p.000517: the Foundation, includ- ing an accounting of the use of amounts provided for under subsection (i).
p.000517: (B) With respect to the financial condition of the Foun- dation, each report under subparagraph (A) shall
p.000517: include the source, and a description of, all gifts to the Foundation of real or personal property, and the source and
p.000517: amount of all gifts to the Foundation of money. Each such report shall include a specification of any
p.000517: restrictions on the pur- poses for which gifts to the Foundation may be used.
p.000517: (C) The Foundation shall make copies of each report submitted under subparagraph (A) available—
p.000517: (i) for public inspection, and shall upon request provide a copy of the report to any individual for a
p.000517: charge not to exceed the cost of providing the copy; and
p.000517:
p.000517:
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p.000517:
p.000517: January 30, 2020
p.000517: (ii) to the appropriate committees of Congress.
p.000517: (8) LIAISON FROM CENTERS FOR DISEASE CONTROL AND PRE- VENTION.—The Director of the Centers for Disease Control
p.000517: and Prevention shall serve as the liaison representative of such Centers to the Board and the Foundation.
p.000517: (i) FEDERAL FUNDING.—
p.000517: (1) AUTHORITY FOR ANNUAL GRANTS.—
p.000517: (A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
p.000517: (i) for fiscal year 1993, make a grant to an entity described in subsection (j)(9) (relating to the establish- ment of
p.000517: a committee to establish the Foundation);
p.000517: (ii) for fiscal year 1994, make a grant to the com- mittee established under such subsection, or if the
p.000517: Foundation has been established, to the Foundation; and
p.000517: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000517:
p.000517:
p.000517:
p.000517:
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p.000517:
p.000517:
p.000519: 519
p.000519: PUBLIC HEALTH SERVICE ACT
p.000519: Sec. 399G
p.000519:
p.000519:
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p.000519:
p.000519:
p.000519:
p.000519: January 30, 2020
p.000519: (iii) for fiscal year 1995 and each subsequent fiscal year, make a grant to the Foundation.
p.000519: (B) A grant under subparagraph (A) may be ex- pended—
...

p.000523: entity shall—
p.000523: (1) be a State, Indian tribal government, local government, scientific or academic institution, or nonprofit
p.000523: organization; and
p.000523: (2) prepare and submit to the Secretary an application at such time, in such manner, and containing such
p.000523: information as the Secretary may prescribe, including a description of the ac- tivities that the entity intends to
p.000523: carry out using amounts re- ceived under this part.
p.000523: SEC. 399J. ø280f–2¿ AUTHORIZATION OF APPROPRIATIONS.
p.000523: (a) IN GENERAL.—There are authorized to be appropriated to carry out this part, $27,000,000 for each of
p.000523: the fiscal years 1999 through 2003.
p.000523: (b) TASK FORCE.—From amounts appropriated for a fiscal year under subsection (a), the Secretary may use
p.000523: not to exceed
p.000523: $2,000,000 of such amounts for the operations of the National Task Force under section 399H(d).
p.000523: SEC. 399K. ø280f–3¿ SUNSET PROVISION.
p.000523: This part shall not apply on the date that is 7 years after the date on which all members of the National Task
p.000523: Force have been appointed under section 399H(d)(1).
p.000523: PART P—ADDITIONAL PROGRAMS
p.000523:
p.000523:
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p.000523:
p.000523: January 30, 2020
p.000523: SEC. 399L. ø280g¿ CHILDREN’S ASTHMA TREATMENT GRANTS PRO- GRAM.
p.000523: (a) AUTHORITY TO MAKE GRANTS.—
p.000523: (1) IN GENERAL.—In addition to any other payments made under this Act or title V of the Social Security Act,
p.000523: the Sec- retary shall award grants to eligible entities to carry out the following purposes:
p.000523: (A) To provide access to quality medical care for chil- dren who live in areas that have a high prevalence of
p.000523: asth- ma and who lack access to medical care.
p.000523: (B) To provide on-site education to parents, children, health care providers, and medical teams to
p.000523: recognize the signs and symptoms of asthma, and to train them in the use of medications to treat asthma and
p.000523: prevent its exacer- bations.
p.000523: (C) To decrease preventable trips to the emergency room by making medication available to individuals who
p.000523: have not previously had access to treatment or education in the management of asthma.
p.000523: (D) To provide other services, such as smoking ces- sation programs, home modification, and other direct
p.000523: and support services that ameliorate conditions that exacerbate or induce asthma.
p.000523: (2) CERTAIN PROJECTS.—In making grants under para- graph (1), the Secretary may make grants designed to
p.000523: develop and expand the following projects:
p.000523: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000535: provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a
p.000535: practitioner, where permitted) requests information about such patient.
p.000535: (e) EVALUATION AND REPORTING.—A State receiving support under this section shall provide the Secretary with
p.000535: aggregate non- identifiable information, as permitted by State law, to enable the Secretary—
p.000535: (1) to evaluate the success of the State’s program in achieving the purpose described in subsection
p.000535: (a); or
p.000535: (2) to prepare and submit to the Congress the report re- quired by subsection (i)(2).
p.000535: (f) EDUCATION AND ACCESS TO THE MONITORING SYSTEM.—A State receiving support under this section shall take
p.000535: steps to—
p.000535: (1) facilitate prescribers and dispensers, and their dele- gates, as permitted by State law, to use the PDMP, to
p.000535: the ex- tent practicable; and
p.000535: (2) educate prescribers and dispensers, and their delegates on the benefits of the use of PDMPs.
p.000535: (g) ELECTRONIC FORMAT.—The Secretary may issue guidelines specifying a uniform electronic format for the
p.000535: reporting, sharing, and disclosure of information pursuant to PDMPs. To the extent possible, such
p.000535: guidelines shall be consistent with standards recog- nized by the Office of the National Coordinator for Health
p.000535: Informa- tion Technology.
p.000535: (h) RULES OF CONSTRUCTION.—
p.000535: (1) FUNCTIONS OTHERWISE AUTHORIZED BY LAW.—Nothing in this section shall be construed to restrict the
p.000535: ability of any authority, including any local, State, or Federal law enforce- ment, narcotics control,
p.000535: licensure, disciplinary, or program au- thority, to perform functions otherwise authorized by law.
p.000535: (2) ADDITIONAL PRIVACY PROTECTIONS.—Nothing in this section shall be construed as preempting any State
p.000535: from im- posing any additional privacy protections.
p.000535: (3) FEDERAL PRIVACY REQUIREMENTS.—Nothing in this sec- tion shall be construed to supersede any Federal
p.000535: privacy or
p.000535: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000537: PUBLIC HEALTH SERVICE ACT
p.000537: Sec. 399O
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p.000537: January 30, 2020
p.000537: confidentiality requirement, including the regulations promul- gated under section 264(c) of the Health Insurance
p.000537: Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 543 of this Act.
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p.000557: January 30, 2020
p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
p.000557: (B) may include entities such as hospital associations, primary care practice-based research networks, health pro-
p.000557: fessional societies, State primary care associations, State licensing boards, organizations with a contract
p.000557: with the Secretary under section 1153 of the Social Security Act, consumer groups, and other appropriate
p.000557: entities.
p.000557: (c) STATE AND LOCAL ACTIVITIES.—
p.000557: (1) HUB ACTIVITIES.—Hubs established under a grant under subsection (b) shall—
p.000557: (A) submit to the Secretary a plan to coordinate func- tions with quality improvement organizations and area
p.000557: health education centers if such entities are members of the Hub not described in subsection (b)(2)(A);
p.000557: (B) contract with a county- or local-level entity that shall serve as the Primary Care Extension Agency
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p.000565: provider, or by any individual working under the supervision of a health care provider, that relate to—
p.000565: (A) the diagnosis, prevention, or treatment of any human disease or impairment; or
p.000565: (B) the assessment of the health of human beings.
p.000565: (2) HEALTH CARE ORGANIZATION.—The term ‘‘health care organization’’ means any individual or entity which is
p.000565: obligated to provide, pay for, or administer health benefits under any health plan.
p.000565: (3) HEALTH CARE PROVIDER.—The term ‘‘health care pro- vider’’ means any individual or entity—
p.000565: (A) licensed, registered, or certified under Federal or State laws or regulations to provide health care
p.000565: services; or
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p.000565: (B) required to be so licensed, registered, or certified but that is exempted by other statute or regulation.
p.000565: (k) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $50,000,000
p.000565: for the 5- fiscal year period beginning with fiscal year 2011.
p.000565: (l) CURRENT STATE EFFORTS TO ESTABLISH ALTERNATIVE TO TORT LITIGATION.—Nothing in this section shall
p.000565: be construed to limit any prior, current, or future efforts of any State to establish any alternative to
p.000565: tort litigation.
p.000565: (m) RULE OF CONSTRUCTION.—Nothing in this section shall be construed as limiting states’ authority over or
p.000565: responsibility for their state justice systems.
p.000565: SEC. 399V–5. ø280g–16¿ FOOD SAFETY INTEGRATED CENTERS OF EX- CELLENCE.
p.000565: (a) IN GENERAL.—Not later than 1 year after the date of enact- ment of the FDA Food Safety Modernization Act,
p.000565: the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation
p.000565: with the working group described in subsection (b)(2), shall designate 5 Integrated Food Safety Cen- ters
p.000565: of Excellence (referred to in this section as the ‘‘Centers of Ex- cellence’’) to serve as resources for Federal,
p.000565: State, and local public health professionals to respond to foodborne illness outbreaks. The Centers of Excellence
p.000565: shall be headquartered at selected State health departments.
p.000565: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000567: PUBLIC HEALTH SERVICE ACT
p.000567: Sec. 399V–5
p.000567:
p.000567: (b) SELECTION OF CENTERS OF EXCELLENCE.—
p.000567: (1) ELIGIBLE ENTITIES.—To be eligible to be designated as a Center of Excellence under subsection
p.000567: (a), an entity shall—
p.000567: (A) be a State health department;
p.000567: (B) partner with 1 or more institutions of higher edu- cation that have demonstrated knowledge, expertise, and
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p.000569: (2) provide standardized methods of reviewing and catego- rizing data, including from health surveillance systems and
p.000569: re- ports of potential cancer clusters; and
p.000569: (3) provide guidance for using appropriate epidemiological and other approaches for investigations.
p.000569: (d) INVESTIGATION OF CANCER CLUSTERS.—
p.000569: (1) SECRETARY DISCRETION.—The Secretary—
p.000569: (A) in consultation with representatives of the relevant State and local health departments, shall consider whether it
p.000569: is appropriate to conduct an investigation of a potential cancer cluster; and
p.000569: (B) in conducting investigations shall have the discre- tion to prioritize certain potential cancer clusters, based on
p.000569: the availability of resources.
p.000569: (2) COORDINATION.—In investigating potential cancer clus- ters, the Secretary shall coordinate with agencies
p.000569: within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection
p.000569: Agency.
p.000569: (3) BIOMONITORING.—In investigating potential cancer clusters, the Secretary shall rely on all
p.000569: appropriate biomoni- toring information collected under other Federal programs, such as the National Health
p.000569: and Nutrition Examination Sur- vey. The Secretary may provide technical assistance for rel- evant
p.000569: biomonitoring studies of other Federal agencies.
p.000569: (e) DUTIES.—The Secretary shall—
p.000569: (1) ensure that appropriate staff of agencies within the De- partment of Health and Human Services are prepared
p.000569: to pro- vide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer
p.000569: cluster from a State or local health authority;
p.000569: (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer
p.000569: surveillance, exposure assessment, pediatric health, pollution control, com- munity outreach, health
p.000569: education, laboratory sampling and analysis, spatial mapping, and informatics;
p.000569: (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary
p.000569: deter- mines appropriate;
p.000569: (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes
p.000569: of such clus- ters, and the actions taken to address such clusters; and
p.000569: (5) provide technical assistance for investigating cancer clusters to State and local health departments through
p.000569: existing programs, such as the Epi-Aids program of the Centers for Dis- ease Control and Prevention and the Assessments
p.000569: of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry.
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p.000569: January 30, 2020 As Amended Through P.L. 116-94,
p.000569: Enacted December 20, 2019
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p.000569: PART Q—PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
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p.000573: PUBLIC HEALTH SERVICE ACT
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p.000573: and adolescents, and other factors as determined ap- propriate by the Secretary.
p.000573: (3) SCHOOL-BASED HEALTH CENTER.—The term ‘‘school- based health center’’ means a health clinic that—
p.000573: (A) meets the definition of a school-based health cen- ter under section 2110(c)(9)(A) of the Social
p.000573: Security Act and is administered by a sponsoring facility (as defined in section 2110(c)(9)(B) of the Social Security
p.000573: Act);
p.000573: (B) provides, at a minimum, comprehensive primary health services during school hours to children and adoles-
p.000573: cents by health professionals in accordance with estab- lished standards, community practice, reporting
p.000573: laws, and other State laws, including parental consent and notifica- tion laws that are not inconsistent
p.000573: with Federal law; and
p.000573: (C) does not perform abortion services.
p.000573: (b) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants for the costs of the operation of school-based health
p.000573: centers (referred to in this section as ‘‘SBHCs’’) that meet the requirements of this section.
p.000573: (c) APPLICATIONS.—To be eligible to receive a grant under this section, an entity shall—
p.000573: (1) be an SBHC (as defined in subsection (a)(3)); and
p.000573: (2) submit to the Secretary an application at such time, in such manner, and containing—
p.000573: (A) evidence that the applicant meets all criteria nec- essary to be designated an SBHC;
p.000573: (B) evidence of local need for the services to be pro- vided by the SBHC;
p.000573: (C) an assurance that—
p.000573: (i) SBHC services will be provided to those chil- dren and adolescents for whom parental or guardian
p.000573: consent has been obtained in cooperation with Fed- eral, State, and local laws governing health care serv- ice
p.000573: provision to children and adolescents;
p.000573: (ii) the SBHC has made and will continue to make every reasonable effort to establish and maintain col-
p.000573: laborative relationships with other health care pro- viders in the catchment area of the SBHC;
p.000573: (iii) the SBHC will provide on-site access during the academic day when school is in session and 24-
p.000573: hour coverage through an on-call system and through its backup health providers to ensure access to
p.000573: serv- ices on a year-round basis when the school or the SBHC is closed;
p.000573: (iv) the SBHC will be integrated into the school environment and will coordinate health services with
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p.000599: TEGIC INITIATIVES.—
p.000599: (1) IN GENERAL.—Within the Office of the Director of the National Institutes of Health, there shall be a
p.000599: Division of Pro- gram Coordination, Planning, and Strategic Initiatives (re- ferred to in this subsection
p.000599: as the ‘‘Division’’).
p.000599: (2) OFFICES WITHIN DIVISION.—
p.000599: (A) OFFICES.—The following offices are within the Di- vision: The Office of AIDS Research, the Office of
p.000599: Research on Women’s Health, the Office of Behavioral and Social Sciences Research, the Office of Disease
p.000599: Prevention, the Office of Dietary Supplements, and any other office located within the Office of the Director of
p.000599: NIH as of the day be- fore the date of the enactment of the National Institutes of Health Reform Act
p.000599: of 2006. In addition to such offices, the Director of NIH may establish within the Division such additional
p.000599: offices or other administrative units as the Di- rector determines to be appropriate.
p.000599: (B) AUTHORITIES.—Each office in the Division—
p.000599: (i) shall continue to carry out the authorities that were in effect for the office before the date of enact-
p.000599: ment referred to in subparagraph (A); and
p.000599: (ii) shall, as determined appropriate by the Direc- tor of NIH, support the Division with respect to the
p.000599: authorities described in section 402(b)(7).
p.000599: (d) ORGANIZATION.—
p.000599: (1) NUMBER OF INSTITUTES AND CENTERS.—In the National Institutes of Health, the number of national research
p.000599: institutes and national centers may not exceed a total of 27, including any such institutes or centers
p.000599: established under authority of paragraph (2) or under authority of this title as in effect on the day before the
p.000599: date of the enactment of the National Institutes of Health Reform Act of 2006.
p.000599: (2) REORGANIZATION OF INSTITUTES.—
p.000599: (A) IN GENERAL.—The Secretary may establish in the National Institutes of Health one or more additional
p.000599: na- tional research institutes to conduct and support research, training, health information, and other programs
p.000599: with re- spect to any particular disease or groups of diseases or any other aspect of human health if—
p.000599: (i) the Secretary determines that an additional in- stitute is necessary to carry out such activities; and
p.000599: (ii) the additional institute is not established be- fore the expiration of 180 days after the Secretary has
p.000599: provided the Committee on Energy and Commerce of
p.000599: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000599: the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate
p.000599: written notice of the determination made under clause
p.000599: (i) with respect to the institute.
p.000599: (B) ADDITIONAL AUTHORITY.—The Secretary may reor- ganize the functions of any national research institute and may
p.000599: abolish any national research institute if the Sec- retary determines that the institute is no longer required.
p.000599: A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after
p.000599: the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and
p.000599: the Com- mittee on Health, Education, Labor, and Pensions of the Senate written notice of the reorganization
p.000599: or abolition.
p.000599: (3) REORGANIZATION OF OFFICE OF DIRECTOR.—Notwith- standing subsection (c), the Director of NIH may, after a
p.000599: series of public hearings, and with the approval of the Secretary, re- organize the offices within the Office of the
p.000599: Director, including the addition, removal, or transfer of functions of such offices, and the establishment or
p.000599: termination of such offices, if the Di- rector determines that the overall management and operation of programs
p.000599: and activities conducted or supported by such of- fices would be more efficiently carried out under such a
p.000599: reorga- nization.
p.000599: (4) INTERNAL REORGANIZATION OF INSTITUTES AND CEN- TERS.—Notwithstanding any conflicting provisions of this
p.000599: title, the director of a national research institute or a national cen- ter may, after a series of public
p.000599: hearings and with the approval of the Director of NIH, reorganize the divisions, centers, or other
p.000599: administrative units within such institute or center, in- cluding the addition, removal, or transfer of
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p.000603: (B) SCOPE OF OBJECTION.—For purposes of subpara- graph (A), an objection by the Director of NIH may be
p.000603: made to the entirety of a recommended organizational change or to 1 or more aspects of the change. Any
p.000603: aspect of a change not objected to by the Director in a report under subparagraph (A) shall be
p.000603: implemented in accord- ance with paragraph (1).
p.000603: (4) CONGRESSIONAL REVIEW.—An organizational change under subsection (d)(2) that is initiated pursuant to
p.000603: paragraph
p.000603: (1) shall be carried out by regulation in accordance with the procedures for substantive rules under
p.000603: section 553 of title 5, United States Code. A rule under the preceding sentence shall be considered a major
p.000603: rule for purposes of chapter 8 of such title (relating to congressional review of agency rulemaking).
p.000603: (g) DEFINITIONS.—For purposes of this title:
p.000603: (1) The term ‘‘Director of NIH’’ means the Director of the National Institutes of Health.
p.000603: (2) The terms ‘‘national research institute’’ and ‘‘national center’’ mean an agency of the National
p.000603: Institutes of Health that is—
p.000603: (A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or
p.000603: (B) established by the Director of NIH under such sub- section.
p.000603: (h) REFERENCES TO NIH.—For purposes of this title, a ref- erence to the National Institutes of Health includes
p.000603: its agencies.
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p.000603: APPOINTMENT AND AUTHORITY OF DIRECTOR OF NIH
p.000603: SEC. 402. ø282¿ (a) The National Institutes of Health shall be headed by the Director of NIH who shall be appointed by
p.000603: the Presi- dent by and with the advice and consent of the Senate. The Direc- tor of NIH shall perform functions as
p.000603: provided under subsection (b) and as the Secretary may otherwise prescribe.
p.000603: (b) In carrying out the purposes of section 301, the Secretary, acting through the Director of NIH—
p.000603: (1) shall carry out this title, including being responsible for the overall direction of the National Institutes
p.000603: of Health and for the establishment and implementation of general policies
p.000603: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000605: PUBLIC HEALTH SERVICE ACT
p.000605: Sec. 402
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p.000605: pediatric research that is identified under subparagraph (A); and
p.000605: (C) may assign additional functions to the Division in sup- port of responsibilities identified in subparagraph (A), as
p.000605: deter- mined appropriate by the Director;
p.000605: (8) shall, in coordination with the heads of the national re- search institutes and national centers, ensure that
p.000605: such insti- tutes and centers—
p.000605: (A) preserve an emphasis on investigator-initiated re- search project grants, including with respect to
p.000605: research involving collaboration between 2 or more such institutes or centers;
p.000605: (B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;
p.000605: (C) foster collaboration between clinical research projects funded by the respective national research
p.000605: insti- tutes and national centers that—
p.000605: (i) conduct research involving human subjects; and
p.000605: (ii) collect similar data; and
p.000605: (D) encourage the collaboration described in subpara- graph (C) to—
p.000605: (i) allow for an increase in the number of subjects studied; and
p.000605: (ii) utilize diverse study populations, with special consideration to biological, social, and other
p.000605: deter- minants of health that contribute to health disparities;
p.000605: (9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review
p.000605: in accord- ance with section 492 and that, after such review, the research is reviewed in accordance with section
p.000605: 492A(a)(2) by the appro- priate advisory council under section 406 before the research proposals are approved
p.000605: for funding;
p.000605: (10) shall have authority to review and approve the estab- lishment of all centers of excellence recommended by
p.000605: the na- tional research institutes;
p.000605: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000607: PUBLIC HEALTH SERVICE ACT
p.000607: Sec. 402
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p.000607: (11)(A) shall oversee research training for all of the na- tional research institutes and National
p.000607: Research Service Awards in accordance with section 487; and
p.000607: (B) may conduct and support research training—
p.000607: (i) for which fellowship support is not provided under section 487; and
p.000607: (ii) that does not consist of residency training of physi- cians or other health professionals;
p.000607: (12) may, from funds appropriated under section 402A(b), reserve funds to provide for research on matters that
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p.000631: January 30, 2020
p.000631: consultation with the directors of the national research insti- tutes and national centers,
p.000631: researchers, patient advocacy groups, and industry leaders.
p.000631: (n) UNIQUE RESEARCH INITIATIVES.—
p.000631: (1) IN GENERAL.—The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A),
p.000631: requests by the national research institutes and centers, or program offi- cers within the Office of the
p.000631: Director to engage in transactions other than a contract, grant, or cooperative agreement with re- spect to projects
p.000631: that carry out—
p.000631: (A) the Precision Medicine Initiative under section 498E;
p.000631: (B) section 402(b)(7), except that not more than 50 percent of the funds available for a fiscal year through
p.000631: the Common Fund under section 402A(c)(1) for purposes of carrying out such section 402(b)(7) may be used to
p.000631: engage in such other transactions; or
p.000631: (C) high impact cutting-edge research that fosters sci- entific creativity and increases fundamental biological
p.000631: un- derstanding leading to the prevention, diagnosis, or treat- ment of diseases and disorders, or
p.000631: research urgently re- quired to respond to a public health threat.
p.000631: (2) REQUIREMENTS.—The authority provided under this subsection may be used to conduct or support high impact
p.000631: cut- ting-edge research described in paragraph (1) using the other transactions authority described in such
p.000631: paragraph if the insti- tute, center, or office—
p.000631: (A) submits a proposal to the Director of NIH for the use of such authority before conducting or
p.000631: supporting the research, including why the use of such authority is essen- tial to promoting the success of the
p.000631: project;
p.000631: (B) receives approval for the use of such authority from the Director of NIH; and
p.000631: (C) for each year in which the institute, center, or of- fice has used such authority in accordance
p.000631: with this sub- section, submits a report to the Director of NIH on the ac- tivities of the institute, center, or
p.000631: office relating to such re- search.
p.000631: SEC. 402A. ø282a¿ AUTHORIZATION OF APPROPRIATIONS.
p.000631: (a) IN GENERAL.—
p.000631: (1) THIS TITLE.—For purposes of carrying out this title, there are authorized to be appropriated—
p.000631: (A) $30,331,309,000 for fiscal year 2007; (B) $32,831,309,000 for fiscal year 2008;
p.000631: (C) such sums as may be necessary for fiscal year 2009;
p.000631: (D) $34,851,000,000 for fiscal year 2018;
p.000631: (E) $35,585,871,000 for fiscal year 2019; and (F) $36,472,442,775 for fiscal year 2020.
p.000631: (2) FUNDING FOR 10-YEAR PEDIATRIC RESEARCH INITIATIVE THROUGH COMMON FUND.—For the purpose of carrying out sec-
p.000631: tion 402(b)(7)(B)(ii), there is authorized to be appropriated to the Common Fund, out of the 10-Year
p.000631: Pediatric Research Ini-
p.000631: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000631: Sec. 402A PUBLIC HEALTH SERVICE ACT 632
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p.000633: the report re- quired by subparagraph (B) for the preceding fiscal year, the amount made available for
p.000633: the institute or center for the fiscal year involved may not exceed the amount made available for the
p.000633: institute or center for fiscal year 2006.
p.000633: (B) REPORTING.—Not later than 2 years after the date of enactment of 21st Century Cures Act, the head of
p.000633: each national research institute or national center shall submit to the Director of the National Institutes of
p.000633: Health a re- port, to be included in the triennial report under section 403, on the amount made available by
p.000633: the institute or cen- ter for conducting or supporting research that involves col- laboration between the institute
p.000633: or center and 1 or more other national research institutes or national centers.
p.000633: (C) DETERMINATION.—For purposes of determining the amount or percentage of funds to be reported under sub-
p.000633: paragraph (B), any amounts made available to an institute or center under section 402(b)(7)(B) shall be included.
p.000633: (D) VERIFICATION OF AMOUNTS.—Upon receipt of each report submitted under subparagraph (B), the Director of
p.000633: NIH shall review and, in cases of discrepancy, verify the accuracy of the amounts specified in the report.
p.000633: (E) WAIVER.—At the request of any national research institute or national center, the Director of NIH may waive
p.000633: the application of this paragraph to such institute or cen- ter if the Director finds that the conduct or
p.000633: support of re- search described in subparagraph (B) is inconsistent with the mission of such institute or
p.000633: center.
p.000633: (d) TRANSFER AUTHORITY.—Of the total amount appropriated under subsection (a)(1) for a fiscal year, the
p.000633: Director of NIH may (in addition to the reservation under subsection (c)(1) for such year) transfer not more than 1
p.000633: percent for programs or activities that are authorized in this title and identified by the Director to
p.000633: receive funds pursuant to this subsection. In making such transfers, the Director may not decrease any
p.000633: appropriation account under sub- section (a)(1) by more than 1 percent.
p.000633: (e) RULE OF CONSTRUCTION.—This section may not be con- strued as affecting the authorities of the Director of
p.000633: NIH under sec- tion 401.
p.000633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000633: Sec. 402B PUBLIC HEALTH SERVICE ACT 634
p.000633:
p.000633: SEC. 402B. ø282b¿ ELECTRONIC CODING OF GRANTS AND ACTIVITIES.
p.000633: The Secretary, acting through the Director of NIH, shall estab- lish an electronic system to uniformly code research
p.000633: grants and ac- tivities of the Office of the Director and of all the national research institutes and national
p.000633: centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the
p.000633: research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting
p.000633: through the Di- rector of NIH, shall provide information on relevant literature and patents that are associated with
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p.000655: workforce diversity;
p.000655: (3) coordinate, as appropriate, with relevant agencies, pro- fessional and academic associations, academic
p.000655: institutions, and others, to improve and update existing information on the bio- medical research workforce in order to
p.000655: inform programs related to the training, recruitment, and retention of biomedical re- searchers; and
p.000655: (4) carry out other activities, including evaluation and oversight of existing programs, as appropriate,
p.000655: to promote the development of the next generation of researchers and earlier research independence.
p.000655: SEC. 404N. ø283p¿ POPULATION FOCUSED RESEARCH.
p.000655: The Director of the National Institutes of Health shall, as ap- propriate, encourage efforts to improve
p.000655: research related to the health of sexual and gender minority populations, including by—
p.000655: (1) facilitating increased participation of sexual and gender minority populations in clinical research supported by
p.000655: the Na- tional Institutes of Health, and reporting on such participation, as applicable;
p.000655: (2) facilitating the development of valid and reliable meth- ods for research relevant to sexual and gender
p.000655: minority popu- lations; and
p.000655: (3) addressing methodological challenges.
p.000655: PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
p.000655: APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH INSTITUTES
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p.000655: January 30, 2020
p.000655: SEC. 405. ø284¿
p.000655: (a) APPOINTMENT.—
p.000655: (1) IN GENERAL.—The Director of the National Cancer In- stitute shall be appointed by the President, and
p.000655: the Directors of the other national research institutes and national centers shall be appointed by the
p.000655: Secretary, acting through the Direc- tor of National Institutes of Health. Each Director of a national research
p.000655: institute or national center shall report directly to the Director of National Institutes of Health.
p.000655: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000657: PUBLIC HEALTH SERVICE ACT
p.000657: Sec. 405
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p.000657: January 30, 2020
p.000657: (2) APPOINTMENT.—
p.000657: (A) TERM.—A Director of a national research institute or national center who is appointed by the Secretary,
p.000657: act- ing through the Director of National Institutes of Health, shall be appointed for 5 years.
p.000657: (B) REAPPOINTMENT.—At the end of the term of a Di- rector of a national research institute or national
p.000657: center, the Director may be reappointed in accordance with stand- ards applicable to the relevant appointment
p.000657: mechanism. There shall be no limit on the number of terms that a Di- rector may serve.
p.000657: (C) VACANCIES.—If the office of a Director of a na- tional research institute or national center becomes
p.000657: vacant before the end of such Director’s term, the Director ap- pointed to fill the vacancy shall be
p.000657: appointed for a 5-year term starting on the date of such appointment.
p.000657: (D) CURRENT DIRECTORS.—Each Director of a national research institute or national center who is serving on the date of
p.000657: enactment of the 21st Century Cures Act shall be deemed to be appointed for a 5-year term under this
p.000657: sub- section beginning on such date of enactment.
p.000657: (E) RULE OF CONSTRUCTION.—Nothing in this sub- section shall be construed to limit the authority of the
p.000657: Sec- retary or the Director of National Institutes of Health to terminate the appointment of a director
p.000657: referred to in sub- paragraph (A) before the expiration of such director’s 5- year term.
p.000657: (F) NATURE OF APPOINTMENT.—Appointments and re- appointments under this subsection shall be made on the
p.000657: basis of ability and experience as it relates to the mission of the National Institutes of Health and its
p.000657: components, including compliance with any legal requirement that the Secretary or Director of National
p.000657: Institutes of Health de- termines relevant.
p.000657: (3) NONAPPLICATION OF CERTAIN PROVISION.—The restric- tions contained in section 202 of the Departments of
p.000657: Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993
p.000657: (Public Law 102–394; 42
p.000657: U.S.C. 238f note) related to consultants and individual sci- entists appointed for limited periods of time
p.000657: shall not apply to Directors appointed under this subsection.
p.000657: (b)(1) In carrying out the purposes of section 301 with respect to human diseases or disorders or other
p.000657: aspects of human health for which the national research institutes were established, the Secretary, acting
p.000657: through the Director of each national research in- stitute—
p.000657: (A) shall encourage and support research, investigations, experiments, demonstrations, and studies in
p.000657: the health sciences related to—
p.000657: (i) the maintenance of health,
p.000657: (ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,
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p.000677: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000677: Sec. 409J PUBLIC HEALTH SERVICE ACT 678
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p.000677: January 30, 2020
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p.000677: change that the Commissioner of Food and Drugs determines to be appropriate.
p.000677: (10) FAILURE TO AGREE.—If a holder of an approved appli- cation for a drug, within 30 days after receiving a
p.000677: request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the
p.000677: Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and
p.000677: Cosmetic Act.
p.000677: (11) NO EFFECT ON AUTHORITY.—Nothing in this subsection limits the authority of the United States to bring an
p.000677: enforce- ment action under the Federal Food, Drug, and Cosmetic Act when a drug lacks appropriate
p.000677: pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement
p.000677: action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the
p.000677: other course of action.
p.000677: (d) AUTHORIZATION OF APPROPRIATIONS.—
p.000677: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section, $25,000,000 for each
p.000677: of fiscal years 2018 through 2022.
p.000677: (2) AVAILABILITY.—Any amount appropriated under para- graph (1) shall remain available to carry out this section
p.000677: until expended.
p.000677: SEC. 409J. ø284q¿ PAIN RESEARCH.
p.000677: (a) RESEARCH INITIATIVES.—
p.000677: (1) IN GENERAL.—The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an
p.000677: aggres- sive program of basic and clinical research on the causes of and potential treatments for pain.
p.000677: (2) ANNUAL RECOMMENDATIONS.—Not less than annually, the Pain Consortium, in consultation with the Division of
p.000677: Pro- gram Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of
p.000677: NIH recommendations on appropriate pain research initiatives that could be under- taken with funds reserved
p.000677: under section 402A(c)(1) for the Common Fund or otherwise available for such initiatives.
p.000677: (3) DEFINITION.—In this subsection, the term ‘‘Pain Con- sortium’’ means the Pain Consortium of the National
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p.000689: (3) Federally Qualified Health Center, community health center, or hospital;
p.000689: (4) agency of any State or local government, including any State department of health; or
p.000689: (5) nonprofit organization.
p.000689: (b) IN GENERAL.—The Secretary, acting through the Adminis- trator of the Health Resources and Services
p.000689: Administration in con- sultation with the Director of the National Institutes of Health and the Director of the
p.000689: Indian Health Service, may make competitive grants to any entity for the purpose of carrying out programs to—
p.000689: (1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure
p.000689: Compensation Act (42
p.000689: U.S.C. 2210 note) for cancer as a preventative health measure;
p.000689: (2) provide appropriate referrals for medical treatment of individuals screened under paragraph (1) and to
p.000689: ensure, to the extent practicable, the provision of appropriate follow-up serv- ices;
p.000689: (3) develop and disseminate public information and edu- cation programs for the detection, prevention, and
p.000689: treatment of radiogenic cancers and diseases; and
p.000689: (4) facilitate putative applicants in the documentation of claims as described in section 5(a) of the
p.000689: Radiation Exposure Compensation Act (42 U.S.C. 2210 note).
p.000689: (c) INDIAN HEALTH SERVICE.—The programs under subsection
p.000689: (a) shall include programs provided through the Indian Health Service or through tribal contracts, compacts,
p.000689: grants, or cooperative agreements with the Indian Health Service and which are deter- mined appropriate to
p.000689: raising the health status of Indians.
p.000689: (d) GRANT AND CONTRACT AUTHORITY.—Entities receiving a grant under subsection (b) may expend the grant
p.000689: to carry out the purpose described in such subsection.
p.000689: (e) HEALTH COVERAGE UNAFFECTED.—Nothing in this section shall be construed to affect any coverage
p.000689: obligation of a govern- mental or private health plan or program relating to an individual referred to under
p.000689: subsection (b)(1).
p.000689: SEC. 417D. ø285a–10¿ RESEARCH, INFORMATION, AND EDUCATION WITH RESPECT TO BLOOD CANCER.
p.000689: (a) JOE MOAKLEY RESEARCH EXCELLENCE PROGRAM.—
p.000689: (1) IN GENERAL.—The Director of NIH shall expand, inten- sify, and coordinate programs for the conduct and
p.000689: support of research with respect to blood cancer, and particularly with re- spect to leukemia, lymphoma, and multiple
p.000689: myeloma.
p.000689:
p.000689:
p.000689:
p.000689: January 30, 2020
p.000689: 18 Section 417B was repealed by section 103(b)(15) of Public Law 109–482 (120 Stat. 3687).
p.000689: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000689: Sec. 417E PUBLIC HEALTH SERVICE ACT 690
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p.000697: such type of cancer.
p.000697: (c) WORKING GROUPS.—For each recalcitrant cancer identified under subsection (b), the Director of the
p.000697: Institute shall convene a working group comprised of representatives of appropriate Federal agencies and other
p.000697: non-Federal entities to provide expertise on, and assist in developing, a scientific framework under
p.000697: subsection (a). The Director of the Institute (or the Director’s designee) shall participate in the meetings
p.000697: of each such working group.
p.000697: (d) REPORTING.—
p.000697: (1) BIENNIAL REPORTS.—The Director of NIH shall ensure that each biennial report under section 403
p.000697: includes informa-
p.000697: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000697: Sec. 418 PUBLIC HEALTH SERVICE ACT 698
p.000697:
p.000697: tion on actions undertaken to carry out each scientific frame- work developed under subsection (a) with
p.000697: respect to a recal- citrant cancer, including the following:
p.000697: (A) Information on research grants awarded by the National Institutes of Health for research relating to such
p.000697: cancer.
p.000697: (B) An assessment of the progress made in improving outcomes (including relative survival rates) for
p.000697: individuals diagnosed with such cancer.
p.000697: (C) An update on activities pertaining to such cancer under the authority of section 413(b)(7).
p.000697: (2) ADDITIONAL ONE-TIME REPORT FOR CERTAIN FRAME- WORKS.—For each recalcitrant cancer identified under
p.000697: sub- section (b)(1), the Director of the Institute shall, not later than 6 years after the initial development
p.000697: of a scientific framework under subsection (a), submit a report to the Congress on the effectiveness of
p.000697: the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention,
p.000697: detec- tion, diagnosis, and treatment of such cancer.
p.000697: (e) RECOMMENDATIONS FOR EXCEPTION FUNDING.—The Director of the Institute shall consider each relevant
p.000697: scientific framework developed under subsection (a) when making recommendations for exception funding for grant
p.000697: applications.
p.000697: (f) DEFINITION.—In this section, the term ‘‘recalcitrant cancer’’ means a cancer for which the five-year
p.000697: relative survival rate is below 50 percent.
p.000697: Subpart 2—National Heart, Lung, and Blood Institute
p.000697:
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p.000697: January 30, 2020
p.000697:
p.000697: PURPOSE OF THE INSTITUTE
p.000697: SEC. 418. ø285b¿ The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this
p.000697: subpart referred to as the ‘‘Institute’’) is the conduct and support of research, training, health information
p.000697: dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the
...

p.000749: ASSOCIATE DIRECTOR FOR PREVENTION
p.000749: SEC. 464M. ø285o–1¿ (a) IN GENERAL.—There shall be in the Institute an Associate Director for Prevention who
p.000749: shall be respon- sible for the full-time coordination and promotion of the programs in the Institute
p.000749: concerning the prevention of drug abuse. The Asso- ciate Director shall be appointed by the Director of the
p.000749: Institute from individuals who because of their professional training or ex- pertise are experts in drug abuse
p.000749: and the prevention of such abuse.
p.000749: (b) REPORT.—The Associate Director for Prevention shall pre- pare for inclusion in the biennial report made
p.000749: under section 407 a description of the prevention activities of the Institute, including a description of the staff
p.000749: and resources allocated to those activities.
p.000749:
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p.000749: January 30, 2020
p.000749:
p.000749: DRUG ABUSE RESEARCH CENTERS
p.000749: SEC. 464N. ø285o–2¿ (a) AUTHORITY.—The Director of the In- stitute may designate National Drug Abuse
p.000749: Research Centers for the purpose of interdisciplinary research relating to drug abuse and other biomedical,
p.000749: behavioral, and social issues related to drug abuse. No entity may be designated as a Center unless an applica-
p.000749: tion therefore has been submitted to, and approved by, the Sec- retary. Such an application shall be
p.000749: submitted in such manner and contain such information as the Secretary may reasonably require. The Secretary may not
p.000749: approve such an application unless—
p.000749: (1) the application contains or is supported by reasonable assurances that—
p.000749: (A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social,
p.000749: and re- lated disciplines, long-term research on drug abuse and to provide coordination of such research among
p.000749: such dis- ciplines;
p.000749: (B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis
p.000749: facili- ties) to carry out the research plan contained in the appli- cation;
p.000749: (C) the applicant has facilities and personnel to pro- vide training in the prevention and treatment of
p.000749: drug abuse;
...

p.000753:
p.000753: Sec. 464U PUBLIC HEALTH SERVICE ACT 754
p.000753:
p.000753: Mental Health Research (hereafter in this section referred to as the ‘‘Office’’). The Office shall be headed by a
p.000753: director, who shall be ap- pointed by the Director of such Institute from among individuals experienced or
p.000753: knowledgeable in the provision of mental health services in rural areas. The Secretary shall carry out
p.000753: the authori- ties established in this section acting through the Director of the Office.
p.000753: (b) COORDINATION OF ACTIVITIES.—The Director of the Office, in consultation with the Director of
p.000753: the Institute and with the Di- rector of the Office of Rural Health Policy, shall—
p.000753: (1) coordinate the research activities of the Department of Health and Human Services as such activities relate
p.000753: to the mental health of residents of rural areas; and
p.000753: (2) coordinate the activities of the Office with similar ac- tivities of public and nonprofit private
p.000753: entities.
p.000753: (c) RESEARCH, DEMONSTRATIONS, EVALUATIONS, AND DISSEMI- NATION.—The Director of the Office may, with respect to
p.000753: the men- tal health of adults and children residing in rural areas—
p.000753: (1) conduct research on conditions that are unique to the residents of rural areas, or more serious or
p.000753: prevalent in such residents;
p.000753: (2) conduct research on improving the delivery of services in such areas; and
p.000753: (3) disseminate information to appropriate public and non- profit private entities.
p.000753: (d) AUTHORITY REGARDING GRANTS AND CONTRACTS.—The Di- rector of the Office may carry out the authorities
p.000753: established in subsection (c) directly and through grants, cooperative agreements, or contracts with public or
p.000753: nonprofit private entities.
p.000753: OFFICE ON AIDS
p.000753: SEC. 464U. ø285p–3¿ The Director of the Institute shall estab- lish within the Institute an Office on AIDS. The Office
p.000753: shall be re- sponsible for the coordination of research and determining the di- rection of the Institute
p.000753: with respect to AIDS research related to—
p.000753: (1) primary prevention of the spread of HIV, including transmission via sexual behavior;
p.000753: (2) mental health services research; and
p.000753: (3) other matters determined appropriate by the Director.
p.000753: Subpart 17—National Institute of Nursing Research
p.000753: PURPOSE OF THE INSTITUTE
p.000753: SEC. 464V. ø285q¿ The general purpose of the National Insti- tute of Nursing Research (in this subpart referred
p.000753: to as the ‘‘Insti- tute’’) is the conduct and support of, and dissemination of informa- tion respecting, basic and
p.000753: clinical nursing research, training, and other programs in patient care research.
p.000753:
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p.000753: January 30, 2020
p.000753: SPECIFIC AUTHORITIES
p.000753: SEC. 464W. ø285q–1¿ To carry out section 464V, the Director of the Institute may provide research training and
p.000753: instruction and establish, in the Institute and other nonprofit institutions, research
p.000753: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000753:
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p.000779: Sec. 480 PUBLIC HEALTH SERVICE ACT 780
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p.000779: January 30, 2020
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p.000779: (ii) FUNDING IN SUBSEQUENT FISCAL YEARS.—An eligible entity receiving an award under clause (i) may apply for
p.000779: additional funding for such project by sub- mitting to the Board the information required under
p.000779: subparagraphs (B) and (C) of paragraph (2). The Di- rector of the Center may fund a project of such eligible
p.000779: entity in an amount not to exceed $15,000,000 for a fiscal year subsequent to the initial award
p.000779: under clause (i).
p.000779: (C) THE CURES ACCELERATION FLEXIBLE RESEARCH AWARDS.—If the Director of the Center determines that the
p.000779: goals and objectives of this section cannot adequately be carried out through a contract, grant, or cooperative
p.000779: agree- ment, the Director of the Center shall have flexible re- search authority to use other transactions to
p.000779: fund projects in accordance with the terms and conditions of this sec- tion. Awards made under such
p.000779: flexible research authority for a fiscal year shall not exceed 20 percent of the total funds appropriated
p.000779: under subsection (g)(1) for such fiscal year.
p.000779: (4) SUSPENSION OF AWARDS FOR DEFAULTS, NONCOMPLI-
p.000779: ANCE WITH PROVISIONS AND PLANS, AND DIVERSION OF FUNDS;
p.000779: REPAYMENT OF FUNDS.—The Director of the Center may sus- pend the award to any entity upon noncompliance by such
p.000779: en- tity with provisions and plans under this section or diversion of funds.
p.000779: (5) AUDITS.—The Director of the Center may enter into agreements with other entities to conduct periodic audits
p.000779: of the projects funded by grants or contracts awarded under this sub- section.
p.000779: (6) CLOSEOUT PROCEDURES.—At the end of a grant or con- tract period, a recipient shall follow the closeout
p.000779: procedures under section 74.71 of title 45, Code of Federal Regulations (or any successor regulation).
p.000779: (7) REVIEW.—A determination by the Director of the Cen- ter as to whether a drug, device, or biological product
p.000779: is a high need cure (for purposes of subsection (a)(3)) shall not be subject to judicial review.
p.000779: (f) COMPETITIVE BASIS OF AWARDS.—Any grant, cooperative agreement, or contract awarded under this section shall
p.000779: be award- ed on a competitive basis.
p.000779: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000779: (1) IN GENERAL.—For purposes of carrying out this section, there are authorized to be appropriated $500,000,000 for
p.000779: fiscal year 2010, and such sums as may be necessary for subsequent fiscal years. Funds appropriated under this
p.000779: section shall be available until expended.
p.000779: (2) LIMITATION ON USE OF FUNDS OTHERWISE APPRO- PRIATED.—No funds appropriated under this Act,
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p.000799: January 30, 2020
p.000799: (B)(i) the majority of the advisory board recommends that, because of such considerations, the Secretary
p.000799: with- hold funds for the research; or
p.000799: (ii) the majority of such board recommends that the Secretary not withhold funds for the research
p.000799: because of such considerations, but the Secretary finds, on the basis of the report submitted under paragraph
p.000799: (5)(B)(ii), that the recommendation is arbitrary and capricious.
p.000799: (2) RULES OF CONSTRUCTION.—Paragraph (1) may not be construed as prohibiting the Secretary from withholding
p.000799: funds for research on the basis of—
p.000799: (A) the inadequacy of the qualifications of the entities that would be involved with the conduct of the
p.000799: research (including the entity that would directly receive the funds from the Secretary), subject to the condition
p.000799: that, with re- spect to the process of review through which the research was recommended for approval for
p.000799: purposes of subsection (a), all findings regarding such qualifications made in such process are conclusive; or
p.000799: (B) the priorities established by the Secretary for the allocation of funds among projects of research
p.000799: that have been so recommended.
p.000799: (3) APPLICABILITY.—The limitation established in para- graph (1) regarding the authority to withhold funds
p.000799: because of ethical considerations shall apply without regard to whether the withholding of funds on such
p.000799: basis is characterized as a disapproval, a moratorium, a prohibition, or other characteriza- tion.
p.000799: (4) PRELIMINARY MATTERS REGARDING USE OF PROCE- DURES.—
p.000799: (A) If the Secretary makes a determination that an ad- visory board should be convened for purposes of paragraph (1),
p.000799: the Secretary shall, through a statement published in the Federal Register, announce the intention of the
p.000799: Sec- retary to convene such a board.
p.000799: (B) A statement issued under subparagraph (A) shall include a request that interested individuals submit to the
p.000799: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000801: 801
p.000801: PUBLIC HEALTH SERVICE ACT
p.000801: Sec. 492A
p.000801:
p.000801: Secretary recommendations specifying the particular indi- viduals who should be appointed to the advisory board
p.000801: in- volved. The Secretary shall consider such recommenda- tions in making appointments to the board.
p.000801: (C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of
p.000801: the 30-day period beginning on the date on which the statement required in subparagraph (A) is made
p.000801: with re- spect to the board.
p.000801: (5) ETHICS ADVISORY BOARDS.—
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p.000807:
p.000807: Sec. 494 PUBLIC HEALTH SERVICE ACT 808
p.000807:
p.000807: (1) shall require that, as a condition of receiving assist- ance, the entity disclose the existence of a
p.000807: financial interest (as defined under subsection (a)) in each public presentation of the results of such project; and
p.000807: (2) may take such other actions as the Secretary deter- mines to be appropriate.
p.000807: (f) DEFINITIONS.—For purposes of this section:
p.000807: (1) The term ‘‘financial interest’’ includes the receipt of consulting fees or honoraria and the ownership of
p.000807: stock or eq- uity.
p.000807: (2) The term ‘‘assistance’’, with respect to conducting a project of research, means a grant, contract,
p.000807: or cooperative agreement.
p.000807: RESEARCH ON PUBLIC HEALTH EMERGENCIES
p.000807: SEC. 494. ø289c¿ If the Secretary determines, after consulta- tion with the Director of NIH, the
p.000807: Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and
p.000807: Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the
p.000807: Director of NIH—
p.000807: (1) shall expedite the review by advisory councils under section 406 and by peer review groups under section
p.000807: 492 of ap- plications for grants for research on such disease or disorder or proposals for contracts for such
p.000807: research;
p.000807: (2) shall exercise the authority in section 3709 of the Re- vised Statutes (41 U.S.C. 5) respecting
p.000807: public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for
p.000807: such research;
p.000807: (3) may provide administrative supplemental increases in existing grants and contracts to support new research
p.000807: relevant to such disease or disorder; and
p.000807: (4) shall disseminate, to health professionals and the pub- lic, information on the cause, prevention, and
p.000807: treatment of such disease or disorder that has been developed in research assisted under this section.
p.000807: The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half
p.000807: the original amount of the grant or contract.
p.000807: COLLABORATIVE USE OF CERTAIN HEALTH SERVICES RESEARCH FUNDS
p.000807: SEC. 494A. ø289c–1¿ The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of
p.000807: part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental
p.000807: health be used collaboratively, as appropriate, and in consultation with the Agency for Health Care
p.000807: Policy Re- search.
p.000807:
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p.000807: January 30, 2020
p.000807: ANIMALS IN RESEARCH
p.000807: SEC. 495. ø289d¿ (a) The Secretary, acting through the Direc- tor of NIH, shall establish guidelines for the
p.000807: following:
p.000807: (1) The proper care of animals to be used in biomedical and behavioral research.
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p.000809: USE OF APPROPRIATIONS UNDER THIS TITLE
p.000809: SEC. 496. ø289e¿ (a) Appropriations to carry out the purposes of this title, unless otherwise expressly
p.000809: provided, may be expended in the District of Columbia for—
p.000809: (1) personal services;
p.000809: (2) stenographic recording and translating services;
p.000809: (3) travel expenses (including the expenses of attendance at meetings when specifically authorized by the
p.000809: Secretary);
p.000809: (4) rental;
p.000809: (5) supplies and equipment;
p.000809: (6) purchase and exchange of medical books, books of ref- erence, directories, periodicals, newspapers,
p.000809: and press clip- pings;
p.000809: (7) purchase, operation, and maintenance of passenger motor vehicles;
p.000809: (8) printing and binding (in addition to that otherwise pro- vided by law); and
p.000809: (9) all other necessary expenses in carrying out this title. Such appropriations may be expended by
p.000809: contract if deemed nec- essary, without regard to section 3709 of the Revised Statutes (41
p.000809: U.S.C. 5).
p.000809: (b)(1) None of the amounts appropriated under this Act for the purposes of this title may be obligated for the
p.000809: construction of facili- ties (including the acquisition of land) unless a provision of this
p.000809: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000809:
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p.000811: PUBLIC HEALTH SERVICE ACT
p.000811: Sec. 498A
p.000811:
p.000811: title establishes express authority for such purpose and unless the Act making appropriations under such provision
p.000811: specifies that the amounts appropriated are available for such purpose.
p.000811: (2) Any grants, cooperative agreements, or contracts authorized in this title for the construction of facilities
p.000811: may be awarded only on a competitive basis.
p.000811: GIFTS
p.000811:
p.000811: SEC. 497. ø289f¿ The Secretary may, in accordance with sec- tion 231, accept conditional gifts for the
p.000811: National Institutes of Health or a national research institute or for the acquisition of grounds or for the
p.000811: erection, equipment, or maintenance of facilities for the National Institutes of Health or a national research
p.000811: insti- tute. Donations of $50,000 or over for the National Institutes of Health or a national research
p.000811: institute for carrying out the pur- poses of this title may be acknowledged by the establishment with- in the
p.000811: National Institutes of Health or a national research institute of suitable memorials to the donors.
p.000811:
p.000811: FETAL RESEARCH
p.000811: SEC. 498. ø289g¿ (a) The Secretary may not conduct or support any research or experimentation, in the United
p.000811: States or in any other country, on a nonviable living human fetus ex utero or a liv- ing human fetus ex
p.000811: utero for whom viability has not been ascertained unless the research or experimentation—
p.000811: (1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its
p.000811: survival to viabil- ity; or
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p.000815: January 30, 2020
p.000815:
p.000815: SEC. 498E. ø289g–5¿ PRECISION MEDICINE INITIATIVE.
p.000815: (a) IN GENERAL.—The Secretary is encouraged to establish and carry out an initiative, to be known as the ‘‘Precision
p.000815: Medicine Ini- tiative’’ (in this section referred to as the ‘‘Initiative’’), to augment efforts to address
p.000815: disease prevention, diagnosis, and treatment.
p.000815: (b) COMPONENTS.—The Initiative described under subsection
p.000815: (a) may include—
p.000815: (1) developing a network of scientists to assist in carrying out the purposes of the Initiative;
p.000815: (2) developing new approaches for addressing scientific, medical, public health, and regulatory science issues;
p.000815: (3) applying genomic technologies, such as whole genomic sequencing, to provide data on the molecular
p.000815: basis of disease;
p.000815: (4) collecting information voluntarily provided by a diverse cohort of individuals that can be used to better
p.000815: understand health and disease; and
p.000815: (5) other activities to advance the goals of the Initiative, as the Secretary determines appropriate.
p.000815: (c) AUTHORITY OF THE SECRETARY.—In carrying out this sec- tion, the Secretary may—
p.000815: (1) coordinate with the Secretary of Energy, private indus- try, and others, as the Secretary determines
p.000815: appropriate, to identify and address the advanced supercomputing and other advanced technology needs for the
p.000815: Initiative;
p.000815: (2) develop and utilize public-private partnerships; and
p.000815: (3) leverage existing data sources.
p.000815: (d) REQUIREMENTS.—In the implementation of the Initiative under subsection (a), the Secretary shall—
p.000815: (1) ensure the collaboration of the National Institutes of Health, the Food and Drug Administration, the
p.000815: Office of the National Coordinator for Health Information Technology, and the Office for Civil Rights of
p.000815: the Department of Health and Human Services;
p.000815: (2) comply with existing laws and regulations for the pro- tection of human subjects involved in
p.000815: research, including the protection of participant privacy;
p.000815: (3) implement policies and mechanisms for appropriate se- cure data sharing across systems that include
p.000815: protections for privacy and security of data;
p.000815: (4) consider the diversity of the cohort to ensure inclusion of a broad range of participants, including consideration
p.000815: of bio- logical, social, and other determinants of health that contribute to health disparities;
p.000815: (5) ensure that only authorized individuals may access controlled or sensitive, identifiable biological
...

p.000817: of Health or other public health officials in the United States to serve in such capacities in other countries,
p.000817: or both;
p.000817: (ii) the conduct and support of studies, projects, and research, which may include stipends, travel and
p.000817: other support for personnel in collaboration with na- tional and international non-profit and for-profit orga-
p.000817: nizations;
p.000817: (iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include
p.000817: undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of
p.000817: accreditation of such courses by the Foundation at the State and national level for college or
p.000817: continuing education credits or for degrees;
p.000817: (iv) programs to support and encourage teachers and students of science at all levels of education and
p.000817: programs for the general public which promote the un- derstanding of science;
p.000817: (v) programs for writing, editing, printing, pub- lishing, and vending of books and other materials; and
p.000817: (vi) the conduct of other activities to carry out and support the purpose described in subsection (b).
p.000817: (E) The Cures Acceleration Network described in sec- tion 480.
p.000817: (2) FEES.—The Foundation may assess fees for the provi- sion of professional, administrative and
p.000817: management services by the Foundation in amounts determined reasonable and ap- propriate by the Executive
p.000817: Director.
p.000817: (3) AUTHORITY OF FOUNDATION.—The Foundation shall be the sole entity responsible for carrying out the
p.000817: activities de- scribed in this subsection.
p.000817: (d) BOARD OF DIRECTORS.—
p.000817: (1) COMPOSITION.—
p.000817: (A) The Foundation shall have a Board of Directors (hereafter referred to in this section as the ‘‘Board’’),
p.000817: which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed
p.000817: members of the Board shall be voting members.
p.000817: (B) The ex officio members of the Board shall be—
p.000817: (i) the Chairman and ranking minority member of the Subcommittee on Health and the Environment (Committee on
p.000817: Energy and Commerce) or their des- ignees, in the case of the House of Representatives;
p.000817: (ii) the Chairman and ranking minority member of the Committee on Labor and Human Resources or their
p.000817: designees, in the case of the Senate;
p.000817: (iii) the Director of the National Institutes of Health; and
p.000817: (iv) the Commissioner of Food and Drugs.
p.000817: (C) The ex officio members of the Board under sub- paragraph (B) shall appoint to the Board individuals from
p.000817: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000817:
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p.000819: 819
p.000819: PUBLIC HEALTH SERVICE ACT
p.000819: Sec. 499
p.000819:
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p.000857:
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p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000859: January 30, 2020
p.000859: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or cooperative agreement, a plan for the evaluation of any
p.000859: project undertaken with funds provided under this section. Such entity shall provide the Secretary with
p.000859: periodic evaluations of the progress of such project and such eval- uation at the completion of such
p.000859: project as the Secretary deter- mines to be appropriate.
p.000859: (f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section,
p.000859: $29,605,000 for each of fiscal years 2018 through 2022.
p.000859: øSection 514A was repealed by section 9017 of Public Law 114–255.¿
p.000859: SEC. 514B. ø290bb–10¿ EVIDENCE-BASED PRESCRIPTION OPIOID AND HEROIN TREATMENT AND INTERVENTIONS DEMONSTRA-
p.000859: TION.
p.000859: (a) GRANTS TO EXPAND ACCESS.—
p.000859: (1) AUTHORITY TO AWARD GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements to
p.000859: State substance abuse agencies, units of local government, nonprofit organizations, and Indian tribes and tribal
p.000859: organizations (as defined in section 4 of the Indian Self-Determination and Edu- cation Assistance Act) that have
p.000859: a high rate, or have had a rapid increase, in the use of heroin or other opioids, in order to permit
p.000859: such entities to expand activities, including an ex- pansion in the availability of evidence-based
p.000859: medication-as- sisted treatment and other clinically appropriate services, with respect to the treatment of
p.000859: addiction in the specific geo- graphical areas of such entities where there is a high rate or rapid
p.000859: increase in the use of heroin or other opioids, such as in rural areas.
p.000859: (2) NATURE OF ACTIVITIES.—Funds awarded under para- graph (1) shall be used for activities that are based on
p.000859: reliable scientific evidence of efficacy in the treatment of problems re- lated to heroin or other opioids.
p.000859: (b) APPLICATION.—To be eligible for a grant, contract, or coop- erative agreement under subsection (a),
p.000859: an entity shall submit an application to the Secretary at such time, in such manner, and ac- companied by such
p.000859: information as the Secretary may reasonably require.
p.000859: (c) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000859: submit, in the ap- plication for such grant, contract, or agreement a plan for the eval- uation of any project
...

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p.000863: January 30, 2020
p.000863:
p.000863: (C) consistent policy enforcement; and
p.000863: (D) environmental changes that limit underage access to alcohol.
p.000863: (4) Public health groups, consumer groups, and the alcohol beverage industry should continue and expand
p.000863: evidence-based efforts to prevent and reduce underage drinking.
p.000863: (5) The entertainment industries have a powerful impact on youth, and they should use rating systems and
p.000863: marketing codes to reduce the likelihood that underage audiences will be exposed to movies, recordings, or television
p.000863: programs with un- suitable alcohol content.
p.000863: (6) The National Collegiate Athletic Association, its mem- ber colleges and universities, and athletic
p.000863: conferences should affirm a commitment to a policy of discouraging alcohol use among underage students and
p.000863: other young fans.
p.000863: (7) Alcohol is a unique product and should be regulated differently than other products by the States and
p.000863: Federal Gov- ernment. States have primary authority to regulate alcohol dis- tribution and sale, and the Federal
p.000863: Government should sup- port and supplement these State efforts. States also have a re- sponsibility to fight youth
p.000863: access to alcohol and reduce under- age drinking. Continued State regulation and licensing of the
p.000863: manufacture, importation, sale, distribution, transportation and storage of alcoholic beverages are clearly in
p.000863: the public in- terest and are critical to promoting responsible consumption, preventing illegal access to
p.000863: alcohol by persons under 21 years of age from commercial and non-commercial sources, maintain- ing industry
p.000863: integrity and an orderly marketplace, and fur- thering effective State tax collection.
p.000863: (c) INTERAGENCY COORDINATING COMMITTEE; ANNUAL REPORT ON STATE UNDERAGE DRINKING PREVENTION AND
p.000863: ENFORCEMENT ACTIVITIES.—
p.000863: (1) INTERAGENCY COORDINATING COMMITTEE ON THE PRE- VENTION OF UNDERAGE DRINKING.—
p.000863: (A) IN GENERAL.—The Secretary, in collaboration with the Federal officials specified in subparagraph (B), shall
p.000863: formally establish and enhance the efforts of the inter- agency coordinating committee, that began
p.000863: operating in 2004, focusing on underage drinking (referred to in this subsection as the ‘‘Committee’’).
...

p.000863: Use, the Director of the Na- tional Institute on Drug Abuse, the Assistant Secretary for Children and Families, the
p.000863: Director of the Office of Na- tional Drug Control Policy, the Administrator of the Na- tional Highway
p.000863: Traffic Safety Administration, the Admin- istrator of the Office of Juvenile Justice and Delinquency
p.000863: Prevention, the Chairman of the Federal Trade Commis-
p.000863: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000863:
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p.000865: 865
p.000865: PUBLIC HEALTH SERVICE ACT
p.000865: Sec. 519B
p.000865:
p.000865: sion, and such other Federal officials as the Secretary of Health and Human Services determines to be
p.000865: appropriate.
p.000865: (C) CHAIR.—The Secretary of Health and Human Serv- ices shall serve as the chair of the Committee.
p.000865: (D) DUTIES.—The Committee shall guide policy and program development across the Federal Government with respect
p.000865: to underage drinking, provided, however, that nothing in this section shall be construed as
p.000865: transferring regulatory or program authority from an Agency to the Co- ordinating Committee.
p.000865: (E) CONSULTATIONS.—The Committee shall actively seek the input of and shall consult with all
p.000865: appropriate and interested parties, including States, public health re- search and interest groups,
p.000865: foundations, and alcohol bev- erage industry trade associations and companies.
p.000865: (F) ANNUAL REPORT.—
p.000865: (i) IN GENERAL.—The Secretary, on behalf of the Committee, shall annually submit to the Congress a report
p.000865: that summarizes—
p.000865: (I) all programs and policies of Federal agen- cies designed to prevent and reduce underage
p.000865: drinking;
p.000865: (II) the extent of progress in preventing and reducing underage drinking nationally;
p.000865: (III) data that the Secretary shall collect with respect to the information specified in clause (ii); and
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p.000865: January 30, 2020
p.000865: (IV) such other information regarding under- age drinking as the Secretary determines to be ap- propriate.
p.000865: (ii) CERTAIN INFORMATION.—The report under clause (i) shall include information on the following:
p.000865: (I) Patterns and consequences of underage drinking as reported in research and surveys such as, but not
...

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p.000891: January 30, 2020
p.000891: crisis.
p.000891: (e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section, $12,500,000
p.000891: for the pe- riod of fiscal years 2018 through 2022.
p.000891: SEC. 520G. ø290bb–38¿ GRANTS FOR JAIL DIVERSION PROGRAMS.
p.000891: (a) PROGRAM AUTHORIZED.—The Secretary shall make up to
p.000891: 125 grants to States, political subdivisions of States, and Indian tribes and tribal organizations (as
p.000891: the terms ‘‘Indian tribes’’ and ‘‘tribal organizations’’ are defined in section 4 of the Indian Self-De-
p.000891: termination and Education Assistance Act), acting directly or through agreements with other public
p.000891: or nonprofit entities, or a health facility or program operated by or in accordance with a con- tract or grant
p.000891: with the Indian Health Service, to develop and im- plement programs to divert individuals with a mental illness
p.000891: from the criminal justice system to community-based services.
p.000891: (b) ADMINISTRATION.—
p.000891: (1) CONSULTATION.—The Secretary shall consult with the Attorney General and any other appropriate officials
p.000891: in car- rying out this section.
p.000891: (2) REGULATORY AUTHORITY.—The Secretary shall issue regulations and guidelines necessary to carry out this
p.000891: section, including methodologies and outcome measures for evaluating programs carried out by States, political
p.000891: subdivisions of States, Indian tribes, and tribal organizations receiving grants under subsection (a).
p.000891: (c) APPLICATIONS.—
p.000891: (1) IN GENERAL.—To receive a grant under subsection (a), the chief executive of a State, chief executive
p.000891: of a subdivision of a State, Indian tribe or tribal organization shall prepare and submit an application to the
p.000891: Secretary at such time, in such manner, and containing such information as the Secretary shall reasonably
p.000891: require.
p.000891: (2) CONTENT.—Such application shall—
p.000891: (A) contain an assurance that—
p.000891: (i) community-based mental health services will be available for the individuals who are diverted from the
p.000891: criminal justice system, and that such services are based on evidence-based practices, reflect current re- search
p.000891: findings, include case management, assertive community treatment, medication management and access,
p.000891: integrated mental health and co-occurring sub- stance use disorder treatment, and psychiatric reha- bilitation,
p.000891: and will be coordinated with social services, including life skills training, housing placement, voca- tional
p.000891: training, education job placement, and health care;
...

p.000907: funds made available under section 521.
p.000907: (b) ENFORCEMENT.—
p.000907: (1) REFERRALS TO ATTORNEY GENERAL AFTER NOTICE.— Whenever the Secretary finds that a State, or an
p.000907: entity that has received a payment pursuant to section 521, has failed to comply with a provision of law
p.000907: referred to in subsection (a)(1), with subsection (a)(2), or with an applicable regulation (includ- ing one prescribed
p.000907: to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the State and shall re-
p.000907: quest the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days,
p.000907: the chief ex- ecutive officer fails or refuses to secure compliance, the Sec- retary may—
p.000907: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.000907: insti- tuted;
p.000907: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.000907: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.000907: Rights Act of 1964, as may be applicable; or
p.000907: (C) take such other actions as may be authorized by
p.000907:
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p.000907: January 30, 2020
p.000907: law.
p.000907: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.000907: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.000907: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.000907: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.000907: the United States for such relief as may be appropriate, including injunc- tive relief.
p.000907: SEC. 534. ø290cc–34¿ DEFINITIONS.
p.000907: For purposes of this part:
p.000907: (1) ELIGIBLE HOMELESS INDIVIDUAL.—The term ‘‘eligible homeless individual’’ means an individual described
p.000907: in section 522(a).
p.000907: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000907:
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p.000907: Sec. 535 PUBLIC HEALTH SERVICE ACT 908
p.000907:
p.000907: (2) HOMELESS INDIVIDUAL.—The term ‘‘homeless indi- vidual’’ has the meaning given such term in
p.000907: section 330(h)(5).
p.000907: (3) STATE.—The term ‘‘State’’ means each of the several States, the District of Columbia, the Commonwealth of
p.000907: Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands.
...

p.000923: developed under sub- section (a) and the common indicators identified or developed under subsection (b) to—
p.000923: (1) State agencies, which may include the provision of technical assistance to State agencies seeking to
p.000923: adopt or im- plement such best practices;
p.000923: (2) Indian tribes, tribal organizations, and tribally des- ignated housing entities;
p.000923: (3) the Attorney General of the United States;
p.000923: (4) the Secretary of Labor;
p.000923: (5) the Secretary of Housing and Urban Development;
p.000923: (6) State and local law enforcement agencies;
p.000923: (7) health insurance issuers;
p.000923: (8) recovery housing entities; and
p.000923: (9) the public.
p.000923: (d) REQUIREMENTS.—In carrying out the activities described in subsections (a) and (b), the Secretary, in
p.000923: consultation with appro- priate individuals and entities described in subsections (a)(2) and (b)(2), shall
p.000923: consider how recovery housing is able to support recov- ery and prevent relapse, recidivism, or overdose (including
p.000923: overdose death), including by improving access and adherence to treatment, including medication-assisted treatment.
p.000923: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000923:
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p.000925: 925
p.000925: PUBLIC HEALTH SERVICE ACT
p.000925: Sec. 551
p.000925:
p.000925: (e) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to provide the Secretary with the
p.000925: authority to require States to adhere to minimum standards in the State oversight of recovery housing.
p.000925: (f) DEFINITIONS.—In this section:
p.000925: (1) The term ‘‘recovery housing’’ means a shared living en- vironment free from alcohol and illicit drug use
p.000925: and centered on peer support and connection to services that promote sus- tained recovery from substance use
p.000925: disorders.
p.000925: (2) The terms ‘‘Indian tribe’’ and ‘‘tribal organization’’ have the meanings given those terms in section 4 of the
p.000925: Indian Self- Determination and Education Assistance Act (25 U.S.C. 5304).
p.000925: (3) The term ‘‘tribally designated housing entity’’ has the meaning given that term in section 4 of the
p.000925: Native American Housing Assistance and Self-Determination Act of 1996 (25
p.000925: U.S.C. 4103).
p.000925: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there is authorized to be appropriated
p.000925: $3,000,000 for the pe- riod of fiscal years 2019 through 2021.
p.000925: SEC. 551. ø290ee–6¿ REGIONAL CENTERS OF EXCELLENCE IN SUB- STANCE USE DISORDER EDUCATION.
p.000925: (a) IN GENERAL.—The Secretary, in consultation with appro- priate agencies, shall award cooperative agreements
p.000925: to eligible en- tities for the designation of such entities as Regional Centers of Ex- cellence in Substance Use
...

p.000937: (2) the description identifies the populations, areas, and lo- calities in the jurisdiction of the entity with a need
p.000937: for services under this section; and
p.000937: (3) the description provides information relating to the services and activities to be provided, including
p.000937: a description of the manner in which the services and activities will be co- ordinated with any similar
p.000937: services or activities of public or nonprofit entities.
p.000937: (h) REQUIREMENT OF APPLICATION.—The Secretary may make a grant under section 561(a) only if an
p.000937: application for the grant is submitted to the Secretary, the application contains the description of intended uses
p.000937: required in subsection (g), and the application is in such form, is made in such manner, and contains
p.000937: such agree- ments, assurances, and information as the Secretary determines to be necessary to carry out this section.
p.000937: SEC. 565. ø290ff–4¿ GENERAL PROVISIONS.
p.000937: (a) DURATION OF SUPPORT.—The period during which pay- ments are made to a public entity from a grant
p.000937: under section 561(a) may not exceed 6 fiscal years.
p.000937: (b) TECHNICAL ASSISTANCE.—
p.000937: (1) IN GENERAL.—The Secretary shall, upon the request of a public entity, regardless of whether such public
p.000937: entity is re- ceiving a grant under section 561(a)—
p.000937: (A) provide technical assistance to the entity regarding the process of submitting to the Secretary applications for
p.000937: grants under section 561(a); and
p.000937: (B) provide to the entity training and technical assist- ance with respect to the planning, development, and oper-
p.000937: ation of systems of care described in section 562.
p.000937: (2) AUTHORITY FOR GRANTS AND CONTRACTS.—The Sec- retary may provide technical assistance under
p.000937: subsection (a) directly or through grants to, or contracts with, public and non- profit private entities.
p.000937: (c) EVALUATIONS AND REPORTS BY SECRETARY.—
p.000937: (1) IN GENERAL.—The Secretary shall, directly or through contracts with public or private entities,
p.000937: provide for annual evaluations of programs carried out pursuant to section 561(a). The evaluations shall assess the
p.000937: effectiveness of the systems of care operated pursuant to such section, including longitudinal studies of
p.000937: outcomes of services provided by such systems, other
p.000937: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000937:
p.000937:
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p.000937: Sec. 565 PUBLIC HEALTH SERVICE ACT 938
p.000937:
p.000937: studies regarding such outcomes, the effect of activities under this part on the utilization of hospital
p.000937: and other institutional settings, the barriers to and achievements resulting from inter- agency collaboration in
p.000937: providing community-based services to children with a serious emotional disturbance, and assess- ments by
p.000937: parents of the effectiveness of the systems of care.
p.000937: (2) REPORT TO CONGRESS.—The Secretary shall, not later than 1 year after the date on which amounts are
...

p.000955: available, are in need of mod- ernization; and
p.000955: (e) that the State plan shall provide for adequate hospitals, and other facilities for which aid under
p.000955: this part is available, for all persons residing in the State, and adequate hospitals (and such other facilities)
p.000955: to furnish needed services for persons unable to pay therefor. Such regulations may also require that before approval
p.000955: of an application for a project is recommended by a State agency to the Surgeon General for approval
p.000955: under this part, assurance shall be received by the State from the applicant that (1) the facility or
p.000955: portion thereof to be constructed or modernized will be made avail- able to all persons residing in the territorial
p.000955: area of the applicant; and (2) there will be made available in the facility or portion there- of to be constructed or
p.000955: modernized a reasonable volume of services to persons unable to pay therefor, but an exception shall be made
p.000955: if such a requirement is not feasible from a financial viewpoint.
p.000955:
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p.000955: January 30, 2020
p.000955:
p.000955: STATE PLANS
p.000955: SEC. 604. ø291d¿ (a) Any State desiring to participate in this part may submit a State plan. Such plan must—
p.000955: (1) designate a single State agency as the sole agency for the administration of the plan, or designate such
p.000955: agency as the sole agency for supervising the administration of the plan;
p.000955: (2) contain satisfactory evidence that the State agency des- ignated in accordance with paragraph (1) will have
p.000955: authority to carry out such plan in conformity with this part;
p.000955: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000955:
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p.000955:
p.000957: 957
p.000957: PUBLIC HEALTH SERVICE ACT
p.000957: Sec. 604
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p.000957: January 30, 2020
p.000957: (3) provide for the designation of a State advisory council which shall include (A) representatives of
p.000957: nongovernmental or- ganizations or groups, and of public agencies, concerned with the operation,
p.000957: construction, or utilization of hospital or other facilities for diagnosis, prevention, or treatment of
p.000957: illness or disease, or for provision of rehabilitation services, and rep- resentatives particularly
p.000957: concerned with education or training of health professions personnel, and (B) an equal number of
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p.000957: Sec. 604 PUBLIC HEALTH SERVICE ACT 958
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p.000957: January 30, 2020
p.000957:
p.000957: tenance and operation make possible, in the order of such rel- ative need;
p.000957: (7) provide minimum standards (to be fixed in the discre- tion of the State) for the maintenance and
p.000957: operation of facili- ties providing inpatient care which receive aid under this part and, effective July 1, 1966,
p.000957: provide for enforcement of such standards with respect to projects approved by the Surgeon General under
p.000957: this part after June 30, 1964;
p.000957: (8) provide such methods of administration of the State plan, including methods relating to the
p.000957: establishment and maintenance of personnel standards on a merit basis (except that the Surgeon General
p.000957: shall exercise no authority with re- spect to the selection, tenure of office, or compensation of any
p.000957: individual employed in accordance with such methods), as are found by the Surgeon General to be
p.000957: necessary for the proper and efficient operation of the plan;
p.000957: (9) provide for affording to every applicant for a construc- tion or modernization project an opportunity
p.000957: for a hearing be- fore the State agency;
p.000957: (10) provide that the State agency will make such reports, in such form and containing such information, as the Surgeon
p.000957: General may from time to time reasonably require, and will keep such records and afford such access
p.000957: thereto as the Sur- geon General may find necessary to assure the correctness and verification of such reports;
p.000957: (11) provide that the Comptroller General of the United States or his duly authorized representatives shall
p.000957: have access for the purpose of audit and examination to the records speci- fied in paragraph (10);
p.000957: (12) provide that the State agency will from time to time, but not less often than annually, review its State
p.000957: plan and sub- mit to the Surgeon General any modifications thereof which it considers necessary; and
p.000957: (13) effective July 1, 1971, provide that before any project for construction or modernization of any general hospital
p.000957: is ap- proved by the State agency there will be reasonable assurance of adequate provision for extended care services
p.000957: (as determined in accordance with regulations) to patients of such hospital when such services are
p.000957: medically appropriate for them, with such services being provided in facilities which (A) are struc-
...

p.000971: room service needed to care for victims of highway, industrial, agricultural, or other acci- dents and to
p.000971: handle other medical emergencies, and to assist in providing such service in geographical areas which
p.000971: have special need therefor.
p.000971: PAYMENTS
p.000971: SEC. 633. ø291j–10¿ Grants under this part shall be paid in advance or by way of reimbursement, in such
p.000971: installments and on such conditions, as in the judgment of the Secretary will best carry out the purposes of this part.
p.000971: PART D—GENERAL
p.000971:
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p.000971: January 30, 2020
p.000971:
p.000971: FEDERAL HOSPITAL COUNCIL AND ADVISORY COMMITTEES
p.000971: SEC. 641. ø291k¿ (a) In administering this title, the Surgeon General shall consult with a Federal Hospital
p.000971: Council consisting of the Surgeon General, who shall serve as Chairman ex officio, and twelve members
p.000971: appointed by the Secretary of Health, Education, and Welfare. Six of the twelve appointed members shall be
p.000971: persons who are outstanding in fields pertaining to medical facility and health activities, and three of these
p.000971: six shall be authorities in mat- ters relating to the operation of hospitals or other medical facilities, one of them
p.000971: shall be an authority in matters relating to individuals with intellectual disabilities, and one of them shall be an
p.000971: authority in matters relating to mental health, and the other six members shall be appointed to represent the
p.000971: consumers of services provided by such facilities and shall be persons familiar with the need for such
p.000971: services in urban or rural areas.
p.000971: (b) Each appointed member shall hold office for a term of four years, except that any member appointed to fill a
p.000971: vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be
p.000971: appointed for the remainder of such term. An appointed member shall not be eligible to serve
p.000971: continuously for more than two terms (whether beginning before or after enactment of this section) but shall be
p.000971: eligible for reappointment if he has not served immediately preceding his reappointment.
p.000971: (c) The Council shall meet as frequently as the Surgeon Gen- eral deems necessary, but not less than
p.000971: once each year. Upon re- quest by three or more members, it shall be the duty of the Sur- geon General
p.000971: to call a meeting of the Council.
p.000971: (d) The Council is authorized to appoint such special advisory or technical committees as may be useful
p.000971: in carrying out its func- tions.
p.000971: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000971:
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p.000973: 973
p.000973: PUBLIC HEALTH SERVICE ACT
p.000973: Sec. 645
p.000973:
p.000973: CONFERENCE OF STATE AGENCIES
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p.000977: this subpart, to continue or complete their educational program or to obtain a loan under section
p.000977: 705(a)(1)(B) to pay interest on such prior loans; but no insurance may be granted for any loan made or installment paid
p.000977: after September 30, 1998. The total principal amount of Fed- eral loan insurance available under this subsection shall
p.000977: be grant- ed by the Secretary without regard to any apportionment for the purpose of chapter 15 of title 31,
p.000977: United States Code, and without regard to any similar limitation.
p.000977: (b) CERTAIN LIMITATIONS AND PRIORITIES.—
p.000977: (1) LIMITATIONS REGARDING LENDERS, STATES, OR AREAS.— The Secretary may, if necessary to assure an equitable
p.000977: dis- tribution of the benefits of this subpart, assign, within the maximum amounts specified in subsection
p.000977: (a), Federal loan in- surance quotas applicable to eligible lenders, or to States or areas, and may from time
p.000977: to time reassign unused portions of these quotas.
p.000977: (2) PRIORITY FOR CERTAIN LENDERS.—In providing certifi- cates of insurance under section 706 through
p.000977: comprehensive contracts, the Secretary shall give priority to eligible lenders that agree—
p.000977: (A) to make loans to students at interest rates below the rates prevailing, during the period involved,
p.000977: for loans covered by Federal loan insurance pursuant to this sub- part; or
p.000977: (B) to make such loans under terms that are otherwise favorable to the student relative to the terms under which
p.000977: eligible lenders are generally making such loans during such period.
p.000977: (c) AUTHORITY OF STUDENT LOAN MARKETING ASSOCIATION.—
p.000977: (1) IN GENERAL.—Subject to paragraph (2), the Student Loan Marketing Association, established under part B
p.000977: of title IV of the Higher Education Act of 1965, is authorized to make advances on the security of, purchase,
p.000977: service, sell, consolidate, or otherwise deal in loans which are insured by the Secretary under this
p.000977: subpart, except that if any loan made under this subpart is included in a consolidated loan pursuant to the au-
p.000977: thority of the Association under part B of title IV of the Higher Education Act of 1965, the interest rate on
p.000977: such consolidated loan shall be set at the weighted average interest rate of all such loans offered for
p.000977: consolidation and the resultant per cen- tum shall be rounded downward to the nearest one-eighth of
p.000977: 1 per centum, except that the interest rate shall be no less than the applicable interest rate of the
p.000977: guaranteed student loan program established under part B of title IV of the Higher Education Act of 1965. In the case
p.000977: of such a consolidated loan, the borrower shall be responsible for any interest which ac-
p.000977: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000981: (c) MINIMUM ANNUAL PAYMENT BY BORROWER.—The total of the payments by a borrower during any year or any
p.000981: repayment pe- riod with respect to the aggregate amount of all loans to that bor- rower which are insured under this
p.000981: subpart shall not be less than the annual interest on the outstanding principal, except as pro- vided in
p.000981: subsection (a)(2)(C), unless the borrower, in the written agreement described in subsection (a)(2), agrees to
p.000981: make payments during any year or any repayment period in a lesser amount.
p.000981: (d) APPLICABILITY OF CERTAIN LAWS ON RATE OR AMOUNT OF INTEREST.—No provision of any law of the United
p.000981: States (other than subsections (a)(2)(D) and (b)) or of any State that limits the rate or amount of
p.000981: interest payable on loans shall apply to a loan insured under this subpart.
p.000981: (e) DETERMINATION REGARDING FORBEARANCE.—Any period of time granted to a borrower under this subpart in
p.000981: the form of for- bearance on the loan shall not be included in the 25-year total loan repayment period under
p.000981: subsection (a)(2)(C).
p.000981: (f) LOAN REPAYMENT SCHEDULE.—Lenders and holders under this subpart shall offer borrowers graduated loan
p.000981: repayment sched- ules that, during the first 5 years of loan repayment, are based on the borrower’s debt-to-income
p.000981: ratio.
p.000981: (g) RULE OF CONSTRUCTION REGARDING DETERMINATION OF NEED OF STUDENTS.—With respect to any
p.000981: determination of the fi- nancial need of a student for a loan covered by Federal loan insur- ance under this
p.000981: subpart, this subpart may not be construed to limit the authority of any school to make such allowances for
p.000981: students with special circumstances as the school determines appropriate.
p.000981: (h) DEFINITIONS.—For purposes of this section:
p.000981: (1) The term ‘‘active duty’’ has the meaning given such term in section 101(18) of title 37, United
p.000981: States Code, except that such term does not include active duty for training.
p.000981: (2) The term ‘‘Persian Gulf conflict’’ means the period be- ginning on August 2, 1990, and ending on
p.000981: the date thereafter prescribed by Presidential proclamation or by law.
p.000981: SEC. 706. ø292e¿ CERTIFICATE OF LOAN INSURANCE; EFFECTIVE DATE OF INSURANCE.
p.000981: (a) IN GENERAL.—
p.000981: (1) AUTHORITY FOR ISSUANCE OF CERTIFICATE.—If, upon ap- plication by an eligible lender, made upon such
p.000981: form, con- taining such information, and supported by such evidence as the Secretary may require, and
p.000981: otherwise in conformity with this section, the Secretary finds that the applicant has made a loan to an
p.000981: eligible borrower which is insurable under the pro- visions of this subpart, he may issue to the applicant a certifi-
p.000981: cate of insurance covering the loan and setting forth the amount and terms of the insurance.
p.000981: (2) EFFECTIVE DATE OF INSURANCE.—Insurance evidenced by a certificate of insurance pursuant to subsection
p.000981: (a)(1) shall become effective upon the date of issuance of the certificate, ex- cept that the Secretary is authorized,
p.000981: in accordance with regu- lations, to issue commitments with respect to proposed loans, or with respect to lines
p.000981: (or proposed lines) of credit, submitted
p.000981: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000983: PUBLIC HEALTH SERVICE ACT
p.000983: Sec. 706
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p.000983: January 30, 2020
p.000983: by eligible lenders, and in that event, upon compliance with subsection (a)(1) by the lender, the certificate
p.000983: of insurance may be issued effective as of the date when any loan, or any pay- ment by the lender
p.000983: pursuant to a line of credit, to be covered by such insurance is made to a student described in
p.000983: section 705(a)(1). Such insurance shall cease to be effective upon 60 days’ default by the lender in the
p.000983: payment of any installment of the premiums payable pursuant to section 708.
p.000983: (3) CERTAIN AGREEMENTS FOR LENDERS.—An application submitted pursuant to subsection (a)(1) shall contain—
p.000983: (A) an agreement by the applicant to pay, in accord- ance with regulations, the premiums fixed by the
p.000983: Sec- retary pursuant to section 708; and
p.000983: (B) an agreement by the applicant that if the loan is covered by insurance the applicant will submit
p.000983: such sup- plementary reports and statements during the effective pe- riod of the loan agreement, upon such
p.000983: forms, at such times, and containing such information as the Secretary may prescribe by or pursuant to
p.000983: regulation.
p.000983: (b) AUTHORITY REGARDING COMPREHENSIVE INSURANCE COV-
p.000983: ERAGE.—
p.000983: (1) IN GENERAL.—In lieu of requiring a separate insurance application and issuing a separate certificate of
p.000983: insurance for each loan made by an eligible lender as provided in subsection (a), the Secretary may, in
p.000983: accordance with regulations con- sistent with section 702, issue to any eligible lender applying therefor
p.000983: a certificate of comprehensive insurance coverage which shall, without further action by the Secretary,
p.000983: insure all insurable loans made by that lender, on or after the date of the certificate and before a specified
p.000983: cutoff date, within the limits of an aggregate maximum amount stated in the certificate. Such regulations
p.000983: may provide for conditioning such insurance, with respect to any loan, upon compliance by the lender with
p.000983: such requirements (to be stated or incorporated by reference in the certificate) as in the Secretary’s judgment will
p.000983: best achieve the purpose of this subsection while protecting the financial in- terest of the United States and
p.000983: promoting the objectives of this subpart, including (but not limited to) provisions as to the re- porting of
p.000983: such loans and information relevant thereto to the Secretary and as to the payment of initial and other
p.000983: premiums and the effect of default therein, and including provision for confirmation by the Secretary from
p.000983: time to time (through en- dorsement of the certificate) of the coverage of specific new loans by such
p.000983: certificate, which confirmation shall be incontest- able by the Secretary in the absence of fraud or misrepresenta-
p.000983: tion of fact or patent error.
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p.000983: lection efforts) by the beneficiary, or may on his own motion, if the insurance is still in effect,
p.000983: pay to the beneficiary the
p.000983: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000985: PUBLIC HEALTH SERVICE ACT
p.000985: Sec. 707
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p.000985: amount of the loss sustained by the insured upon that loan as soon as that amount has been determined, except
p.000985: that, if the insurance beneficiary including any servicer of the loan is not designated for ‘‘exceptional
p.000985: performance’’, as set forth in para- graph (2), the Secretary shall pay to the beneficiary a sum equal
p.000985: to 98 percent of the amount of the loss sustained by the insured upon that loan.
p.000985: (2) EXCEPTIONAL PERFORMANCE.—
p.000985: (A) AUTHORITY.—Where the Secretary determines that an eligible lender, holder, or servicer has a compliance per-
p.000985: formance rating that equals or exceeds 97 percent, the Sec- retary shall designate that eligible lender,
p.000985: holder, or servicer, as the case may be, for exceptional performance.
p.000985: (B) COMPLIANCE PERFORMANCE RATING.—For purposes of subparagraph (A), a compliance performance rating is
p.000985: determined with respect to compliance with due diligence in the disbursement, servicing, and
p.000985: collection of loans under this subpart for each year for which the determina- tion is made. Such rating shall be
p.000985: equal to the percentage of all due diligence requirements applicable to each loan, on average, as
p.000985: established by the Secretary, with respect to loans serviced during the period by the eligible lender,
p.000985: holder, or servicer.
p.000985: (C) ANNUAL AUDITS FOR LENDERS, HOLDERS, AND SERVICERS.—Each eligible lender, holder, or servicer desir-
p.000985: ing a designation under subparagraph (A) shall have an annual financial and compliance audit conducted
p.000985: with re- spect to the loan portfolio of such eligible lender, holder, or servicer, by a qualified independent
p.000985: organization from a list of qualified organizations identified by the Secretary and in accordance with
p.000985: standards established by the Sec- retary. The standards shall measure the lender’s, holder’s, or servicer’s
p.000985: compliance with due diligence standards and shall include a defined statistical sampling technique de-
p.000985: signed to measure the performance rating of the eligible lender, holder, or servicer for the purpose of
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p.000985: (E) QUARTERLY COMPLIANCE AUDIT.—To maintain its status as an exceptional performer, the lender, holder,
p.000985: or servicer shall undergo a quarterly compliance audit at the end of each quarter (other than the quarter in
p.000985: which sta- tus as an exceptional performer is established through a fi- nancial and compliance audit, as
p.000985: described in subpara- graph (C)), and submit the results of such audit to the Sec- retary. The compliance audit shall
p.000985: review compliance with due diligence requirements for the period beginning on the
p.000985: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000985: Sec. 707 PUBLIC HEALTH SERVICE ACT 986
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p.000985: day after the ending date of the previous audit, in accord- ance with standards determined by the Secretary.
p.000985: (F) REVOCATION AUTHORITY.—The Secretary shall re- voke the designation of a lender, holder, or servicer under
p.000985: subparagraph (A) if any quarterly audit required under subparagraph (E) is not received by the Secretary
p.000985: by the date established by the Secretary or if the audit indicates the lender, holder, or servicer has failed
p.000985: to meet the stand- ards for designation as an exceptional performer under subparagraph (A). A lender, holder, or
p.000985: servicer receiving a compliance audit not meeting the standard for designation as an exceptional performer may
p.000985: reapply for designation under subparagraph (A) at any time.
p.000985: (G) DOCUMENTATION.—Nothing in this section shall restrict or limit the authority of the Secretary to
p.000985: require the submission of claims documentation evidencing serv- icing performed on loans, except that the
p.000985: Secretary may not require exceptional performers to submit greater docu- mentation than that required for
p.000985: lenders, holders, and servicers not designated under subparagraph (A).
p.000985: (H) COST OF AUDITS.—Each eligible lender, holder, or servicer shall pay for all the costs associated with the
p.000985: au- dits required under this section.
p.000985: (I) ADDITIONAL REVOCATION AUTHORITY.—Notwith- standing any other provision of this section, a designation
p.000985: under subparagraph (A) may be revoked at any time by the Secretary if the Secretary determines that the
p.000985: eligible lender, holder, or servicer has failed to maintain an overall level of compliance consistent with the audit
p.000985: submitted by the eligible lender, holder, or servicer under this para- graph or if the Secretary asserts
p.000985: that the lender, holder, or servicer may have engaged in fraud in securing designa- tion under subparagraph (A)
p.000985: or is failing to service loans in accordance with program requirements.
p.000985: (J) NONCOMPLIANCE.—A lender, holder, or servicer designated under subparagraph (A) that fails to
p.000985: service loans or otherwise comply with applicable program regula- tions shall be considered in violation of the
p.000985: Federal False Claims Act.
p.000985: (b) SUBROGATION.—Upon payment by the Secretary of the amount of the loss pursuant to subsection
p.000985: (a), the United States shall be subrogated for all of the rights of the holder of the obliga- tion upon the
p.000985: insured loan and shall be entitled to an assignment of the note or other evidence of the insured loan
p.000985: by the insurance beneficiary. If the net recovery made by the Secretary on a loan after deduction of
p.000985: the cost of that recovery (including reasonable administrative costs) exceeds the amount of the loss, the
p.000985: excess shall be paid over to the insured. The Secretary may sell without recourse to eligible lenders (or
p.000985: other entities that the Secretary de- termines are capable of dealing in such loans) notes or other evi-
p.000985: dence of loans received through assignment under the first sen- tence.
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p.000987: necessary care and diligence, exercise substantial effort, or comply with such re- quirements, as the case may
p.000987: be.
p.000987: (e) DEFINITIONS.—For purposes of this section:
p.000987: (1) The term ‘‘insurance beneficiary’’ means the insured or its authorized assignee in accordance with section 706(c).
p.000987: (2) The term ‘‘amount of the loss’’ means, with respect to a loan, unpaid balance of the principal amount and
p.000987: interest on such loan, less the amount of any judgment collected pursuant to default proceedings commenced by the
p.000987: eligible lender or holder involved.
p.000987: (3) The term ‘‘default’’ includes only such defaults as have existed for 120 days.
p.000987: (4) The term ‘‘servicer’’ means any agency acting on behalf of the insurance beneficiary.
p.000987: (f) REDUCTIONS IN FEDERAL REIMBURSEMENTS OR PAYMENTS FOR DEFAULTING BORROWERS.—The Secretary shall,
p.000987: after notice and opportunity for a hearing, cause to be reduced Federal reim- bursements or payments for
p.000987: health services under any Federal law to borrowers who are practicing their professions and have de- faulted
p.000987: on their loans insured under this subpart in amounts up to the remaining balance of such loans. Procedures for
p.000987: reduction of payments under the medicare program are provided under section 1892 of the Social Security Act.
p.000987: Notwithstanding such section 1892, any funds recovered under this subsection shall be deposited in the insurance fund
p.000987: established under section 710.
p.000987: (g) CONDITIONS FOR DISCHARGE OF DEBT IN BANKRUPTCY.— Notwithstanding any other provision of Federal
p.000987: or State law, a debt that is a loan insured under the authority of this subpart may be released by a discharge in
p.000987: bankruptcy under any chapter of title 11, United States Code, only if such discharge is granted—
p.000987: (1) after the expiration of the seven-year period beginning on the first date when repayment of such loan is required,
p.000987: ex- clusive of any period after such date in which the obligation to pay installments on the loan is suspended;
p.000987: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000987: Sec. 707 PUBLIC HEALTH SERVICE ACT 988
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p.000987: (2) upon a finding by the Bankruptcy Court that the non- discharge of such debt would be unconscionable; and
p.000987: (3) upon the condition that the Secretary shall not have waived the Secretary’s rights to apply subsection (f)
p.000987: to the bor- rower and the discharged debt.
p.000987: (h) REQUIREMENT REGARDING ACTIONS FOR DEFAULT.—
p.000987: (1) IN GENERAL.—With respect to the default by a borrower on any loan covered by Federal loan insurance under this sub-
p.000987: part, the Secretary shall, under subsection (a), require an eligi- ble lender or holder to commence and
p.000987: prosecute an action for such default unless—
p.000987: (A) in the determination of the Secretary—
p.000987: (i) the eligible lender or holder has made reason- able efforts to serve process on the borrower
p.000987: involved and has been unsuccessful with respect to such efforts, or
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p.000987: including providing information con- cerning the borrower to the Secretary and to past and present lend-
p.000987: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000989: 989
p.000989: PUBLIC HEALTH SERVICE ACT
p.000989: Sec. 708
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p.000989: January 30, 2020
p.000989: ers and holders of the borrower’s loans, contacting the borrower in order to encourage repayment, and withholding
p.000989: services in accord- ance with regulations issued by the Secretary under section 715(a)(7). The
p.000989: institution or postgraduate training program shall not be subject to section 809 of the Fair Debt
p.000989: Collection Practices Act for purposes of carrying out activities authorized by this sec- tion.
p.000989: SEC. 708. ø292g¿ RISK-BASED PREMIUMS.
p.000989: (a) AUTHORITY.—With respect to a loan made under this sub- part on or after January 1, 1993, the Secretary, in
p.000989: accordance with subsection (b), shall assess a risk-based premium on an eligible borrower and, if required
p.000989: under this section, an eligible institution that is based on the default rate of the eligible institution involved (as
p.000989: defined in section 719).
p.000989: (b) ASSESSMENT OF PREMIUM.—Except as provided in sub- section (d)(2), the risk-based premium to be
p.000989: assessed under sub- section (a) shall be as follows:
p.000989: (1) LOW-RISK RATE.—With respect to an eligible borrower seeking to obtain a loan for attendance at an
p.000989: eligible institu- tion that has a default rate of not to exceed five percent, such borrower shall be assessed a
p.000989: risk-based premium in an amount equal to 6 percent of the principal amount of the loan.
p.000989: (2) MEDIUM-RISK RATE.—
p.000989: (A) IN GENERAL.—With respect to an eligible borrower seeking to obtain a loan for attendance at an eligible insti-
p.000989: tution that has a default rate of in excess of five percent but not to exceed 10 percent—
p.000989: (i) such borrower shall be assessed a risk-based premium in an amount equal to 8 percent of the prin- cipal
p.000989: amount of the loan; and
p.000989: (ii) such institution shall be assessed a risk-based premium in an amount equal to 5 percent of the prin- cipal amount
p.000989: of the loan.
...

p.000991: deposited in the Account.
p.000991: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000991:
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p.000991: Sec. 711 PUBLIC HEALTH SERVICE ACT 992
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p.000991: January 30, 2020
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p.000991: (B) With respect to amounts described in subpara- graph (A) that are received by the Secretary for fiscal year
p.000991: 1993 and subsequent fiscal years, the Secretary may, be- fore depositing such amounts in the Account, reserve
p.000991: from the amounts each such fiscal year not more than
p.000991: $1,000,000 for obligation under section 709(d).
p.000991: (3) EXPENDITURES.—All payments in connection with the default of loans insured by the Secretary under
p.000991: this subpart shall be paid from the Account.
p.000991: (b) CONTINGENT AUTHORITY FOR ISSUANCE OF NOTES OR OTHER OBLIGATIONS.—If at any time the moneys in the Account
p.000991: are insuf- ficient to make payments in connection with the collection or de- fault of any loan insured
p.000991: by the Secretary under this subpart, the Secretary of the Treasury may lend the Account such amounts as
p.000991: may be necessary to make the payments involved, subject to the Federal Credit Reform Act of 1990.
p.000991: SEC. 711. ø292j¿ POWERS AND RESPONSIBILITIES OF SECRETARY.
p.000991: (a) IN GENERAL.—In the performance of, and with respect to, the functions, powers, and duties vested in
p.000991: the Secretary by this subpart, the Secretary is authorized as follows:
p.000991: (1) To prescribe such regulations as may be necessary to carry out the purposes of this subpart.
p.000991: (2) To sue and be sued in any district court of the United States. Such district courts shall have jurisdiction
p.000991: of civil ac- tions arising under this subpart without regard to the amount in controversy, and any action instituted
p.000991: under this subsection by or against the Secretary shall survive notwithstanding any change in the person
p.000991: occupying the office of Secretary or any vacancy in that office. No attachment, injunction, garnishment, or other
p.000991: similar process, mesne or final, shall be issued against the Secretary or property under the control of the
p.000991: Secretary. Nothing herein shall be constructed to except litigation arising out of activities under this subpart from
p.000991: the application of sec- tions 517 and 547 of title 28 of the United States Code.
p.000991: (3) To include in any contract for Federal loan insurance
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p.000997: Sec. 722 PUBLIC HEALTH SERVICE ACT 998
p.000997:
p.000997: (1) IN GENERAL.—Loans from a student loan fund (estab- lished under an agreement with a school under
p.000997: section 721) may not, subject to paragraph (2), exceed for any student for a school year (or its equivalent)
p.000997: the cost of attendance (includ- ing tuition, other reasonable educational expenses, and reason- able living costs) for
p.000997: that year at the educational institution at- tended by the student (as determined by such educational in-
p.000997: stitution).
p.000997: (2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For purposes of paragraph (1), the amount of the loan may,
p.000997: in the case of the third or fourth year of a student at a school of med- icine or osteopathic medicine, be
p.000997: increased to the extent nec- essary to pay the balances of loans that, from sources other than the
p.000997: student loan fund under section 721, were made to the individual for attendance at the school. The
p.000997: authority to make such an increase is subject to the school and the student agreeing that such amount (as
p.000997: increased) will be expended to pay such balances.
p.000997: (b) TERMS AND CONDITIONS.—Subject to section 723, any such loans shall be made on such terms and
p.000997: conditions as the school may determine, but may be made only to a student—
p.000997: (1) who is in need of the amount thereof to pursue a full- time course of study at the school leading to a
p.000997: degree of doctor of medicine, doctor of dentistry or an equivalent degree, doctor of osteopathy, bachelor of science in
p.000997: pharmacy or an equivalent degree, doctor of pharmacy or an equivalent degree, doctor of podiatric medicine or
p.000997: an equivalent degree, doctor of optometry or an equivalent degree, or doctor of veterinary medicine or an equivalent
p.000997: degree; and
p.000997: (2) who, if required under section 3 of the Military Selec- tive Service Act to present himself for
p.000997: and submit to registra- tion under such section, has presented himself and submitted to registration under
p.000997: such section.
p.000997: (c) REPAYMENT; EXCLUSIONS FROM REPAYMENT PERIOD.—Such loans shall be repayable in equal or graduated
p.000997: periodic install- ments (with the right of the borrower to accelerate repayment) over the period of not less than 10
p.000997: years nor more than 25 years, at the discretion of the institution, which begins one year after the stu- dent
p.000997: ceases to pursue a full-time course of study at a school of med- icine, osteopathic medicine, dentistry, pharmacy,
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p.000999: Sec. 722 PUBLIC HEALTH SERVICE ACT 1000
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p.000999: January 30, 2020
p.000999:
p.000999: ing of such evidence is made within 60 days after the date on which such installment or filing is
p.000999: due. The amount of any such charge may not exceed an amount equal to 6 percent of the amount of such installment.
p.000999: The school may elect to add the amount of any such charge to the principal amount of the loan as of the first day after
p.000999: the day on which such installment or evidence was due, or to make the amount of the charge payable to the school not
p.000999: later than the due date of the next installment after receipt by the borrower of notice of the assessment of
p.000999: the charge.
p.000999: (j) AUTHORITY OF SCHOOLS REGARDING RATE OF PAYMENT.—A school may provide, in accordance with regulations
p.000999: of the Sec- retary, that during the repayment period of a loan from a loan fund established pursuant to an agreement
p.000999: under this subpart payments of principal and interest by the borrower with respect to all the outstanding
p.000999: loans made to him from loan funds so established shall be at a rate equal to not less than $40 per month.
p.000999: (k) AUTHORITY REGARDING REPAYMENTS BY SECRETARY.—Upon application by a person who received, and is under
p.000999: an obligation to repay, any loan made to such person as a health professions stu- dent to enable him to study
p.000999: medicine, osteopathy, dentistry, veteri- nary medicine, optometry, pharmacy, or podiatry, the Secretary may
p.000999: undertake to repay (without liability to the applicant) all or any part of such loan, and any interest
p.000999: or portion thereof out- standing thereon, upon his determination, pursuant to regulations establishing
p.000999: criteria therefor, that the applicant—
p.000999: (1) failed to complete such studies leading to his first pro- fessional degree;
p.000999: (2) is in exceptionally needy circumstances;
p.000999: (3) is from a low-income or disadvantaged family as those terms may be defined by such regulations; and
p.000999: (4) has not resumed, or cannot reasonably be expected to resume, the study of medicine, osteopathy,
p.000999: dentistry, veteri- nary medicine, optometry, pharmacy, or podiatric medicine, within two years following the
p.000999: date upon which he terminated such studies.
p.000999: (l) COLLECTION EFFORTS BY SECRETARY.—The Secretary is au- thorized to attempt to collect any loan which was made
p.000999: under this subpart, which is in default, and which was referred to the Sec- retary by a school with
p.000999: which the Secretary has an agreement under this subpart, on behalf of that school under such terms and conditions
p.000999: as the Secretary may prescribe (including reimburse- ment from the school’s student loan fund for
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p.001013: January 30, 2020
p.001013: (1) IN GENERAL.—Any designated health professions school receiving a grant under subsection (a) and meeting the
p.001013: condi- tions described in paragraph (2) or (5) of subsection (c) shall, for purposes of this section, be
p.001013: designated by the Secretary as a Center of Excellence in Under-Represented Minority Health Professions
p.001013: Education.
p.001013: (2) HISPANIC CENTERS OF EXCELLENCE.—Any designated health professions school receiving a grant under subsection
p.001013: (a) and meeting the conditions described in subsection (c)(3) shall, for purposes of this section, be designated by the
p.001013: Secretary as a Hispanic Center of Excellence in Health Professions Edu- cation.
p.001013: (3) NATIVE AMERICAN CENTERS OF EXCELLENCE.—Any des- ignated health professions school receiving a grant under
p.001013: sub- section (a) and meeting the conditions described in subsection (c)(4) shall, for purposes of this
p.001013: section, be designated by the Secretary as a Native American Center of Excellence in Health Professions Education.
p.001013: Any consortium receiving such a grant pursuant to subsection (e) shall, for purposes of this section, be so
p.001013: designated.
p.001013: (e) AUTHORITY REGARDING NATIVE AMERICAN CENTERS OF EX- CELLENCE.—With respect to meeting the conditions
p.001013: specified in subsection (c)(4), the Secretary may make a grant under subsection
p.001013: (a) to a designated health professions school that does not meet such conditions if—
p.001013: (1) the school has formed a consortium in accordance with subsection (d)(1); and
p.001013: (2) the schools of the consortium collectively meet such conditions, without regard to whether the
p.001013: schools individually meet such conditions.
p.001013: (f) DURATION OF GRANT.—The period during which payments are made under a grant under subsection (a) may
p.001013: not exceed 5 years. Such payments shall be subject to annual approval by the Secretary and to the
p.001013: availability of appropriations for the fiscal year involved to make the payments.
p.001013: (g) DEFINITIONS.—In this section:
p.001013: (1) DESIGNATED HEALTH PROFESSIONS SCHOOL.—
p.001013: (A) IN GENERAL.—The term ‘‘health professions school’’ means, except as provided in subparagraph (B), a school of
p.001013: medicine, a school of osteopathic medicine, a school of den- tistry, a school of pharmacy, or a graduate program in be-
p.001013: havioral or mental health.
p.001013: (B) EXCEPTION.—The definition established in sub- paragraph (A) shall not apply to the use of the term ‘‘des-
p.001013: ignated health professions school’’ for purposes of sub- section (c)(2).
p.001013: (2) PROGRAM OF EXCELLENCE.—The term ‘‘program of ex- cellence’’ means any program carried out by a
p.001013: designated health professions school with a grant made under subsection (a), if the program is for purposes
p.001013: for which the school involved is authorized in subsection (b) or (c) to expend the grant.
...

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p.001019: January 30, 2020
p.001019: (C) provide an assurance that the individual that will receive the fellowship will be a member of the faculty
p.001019: of the applicant school; and
p.001019: (D) provide an assurance that the individual that will receive the fellowship will have, at a minimum, appro-
p.001019: priate advanced preparation (such as a master’s or doc- toral degree) and special skills necessary to enable
p.001019: such in- dividual to teach and practice.
p.001019: (5) DEFINITION.—For purposes of this subsection, the term ‘‘underrepresented minority individuals’’ means
p.001019: individuals who are members of racial or ethnic minority groups that are underrepresented in the health
p.001019: professions including nursing.
p.001019: SEC. 739. ø293c¿ EDUCATIONAL ASSISTANCE IN THE HEALTH PROFES- SIONS REGARDING INDIVIDUALS FROM DISADVANTAGED
p.001019: BACKGROUNDS.
p.001019: (a) IN GENERAL.—
p.001019: (1) AUTHORITY FOR GRANTS.—For the purpose of assisting individuals from disadvantaged backgrounds, as determined
p.001019: in accordance with criteria prescribed by the Secretary, to under- take education to enter a health profession, the
p.001019: Secretary may make grants to and enter into contracts with schools of medi- cine, osteopathic medicine,
p.001019: public health, dentistry, veterinary medicine, optometry, pharmacy, allied health, chiropractic, and podiatric
p.001019: medicine, public and nonprofit private schools that offer graduate programs in behavioral and mental health, pro-
p.001019: grams for the training of physician assistants, and other public or private nonprofit health or educational
p.001019: entities to assist in meeting the costs described in paragraph (2).
p.001019: (2) AUTHORIZED EXPENDITURES.—A grant or contract under paragraph (1) may be used by the entity to meet the cost of—
p.001019: (A) identifying, recruiting, and selecting individuals from disadvantaged backgrounds, as so determined, for
p.001019: education and training in a health profession;
p.001019: (B) facilitating the entry of such individuals into such a school;
p.001019: (C) providing counseling, mentoring, or other services designed to assist such individuals to complete
p.001019: successfully their education at such a school;
p.001019: (D) providing, for a period prior to the entry of such individuals into the regular course of education
...

p.001089: (1) provide registered nurses with full-time anesthetist education; and
p.001089: (2) are accredited by the Council on Accreditation of Nurse Anesthesia Educational Programs.
p.001089: (f) OTHER AUTHORIZED EDUCATIONAL PROGRAMS.—The Sec- retary shall prescribe guidelines as appropriate for
p.001089: other advanced nurse education programs eligible for support under this section.
p.001089: (g) TRAINEESHIPS.—
p.001089: (1) IN GENERAL.—The Secretary may not award a grant to an applicant under subsection (a) unless the applicant involved
p.001089: agrees that traineeships provided with the grant will only pay all or part of the costs of—
p.001089: (A) the tuition, books, and fees of the program of ad- vanced nurse education with respect to
p.001089: which the traineeship is provided; and
p.001089: (B) the reasonable living expenses of the individual during the period for which the traineeship is provided.
p.001089: (2) SPECIAL CONSIDERATION.—In making awards of grants and contracts under subsection (a)(2), the
p.001089: Secretary shall give special consideration to an eligible entity that agrees to expend the award to train advanced
p.001089: education nurses who will practice in health professional shortage areas designated under section 332.
p.001089:
p.001089: PART C—INCREASING NURSING WORKFORCE DIVERSITY
p.001089: SEC. 821. ø296m¿ WORKFORCE DIVERSITY GRANTS.
p.001089: (a) 1 IN GENERAL.—
p.001089: (1) AUTHORITY.—The Secretary may award grants to and enter into contracts with eligible entities to meet
p.001089: the costs of special projects to increase nursing education opportunities for individuals who are from
p.001089: disadvantaged backgrounds (includ- ing racial and ethnic minorities underrepresented among reg- istered
p.001089: nurses) by providing student scholarships or stipends, stipends for diploma or associate degree nurses to
p.001089: enter a bridge or degree completion program, student scholarships or
p.001089:
p.001089:
p.001089:
p.001089: January 30, 2020
p.001089: 1 So in law. There is no paragraph (2) in subsection (a).
p.001089: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001089:
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p.001089:
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p.001091: 1091
p.001091: PUBLIC HEALTH SERVICE ACT
p.001091: Sec. 831
p.001091:
p.001091: stipends for accelerated nursing degree programs, pre-entry preparation, advanced education preparation, and
p.001091: retention ac- tivities.
p.001091: (b) GUIDANCE.—In carrying out subsection (a), the Secretary shall take into consideration the
p.001091: recommendations of the National Advisory Council on Nurse Education and Practice and consult with nursing
...

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p.001131: January 30, 2020
p.001131: (B) AGAINST STATE EMPLOYEES.—An entity that is a State or an agency of a State government may not
p.001131: assert the privilege described in subsection (a) unless before the time of the assertion, the entity or, in the
p.001131: case of and with respect to an agency, the State has consented to be subject to an action described in
p.001131: subparagraph (A), and that con- sent has remained in effect.
p.001131: (g) RULE OF CONSTRUCTION.—Nothing in this section shall be construed—
p.001131: (1) to limit the application of other Federal, State, or local laws that provide greater privilege or
p.001131: confidentiality protec- tions than the privilege and confidentiality protections pro- vided for in this
p.001131: section;
p.001131: (2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to
p.001131: information that is not privi- leged or confidential under this section;
p.001131: (3) except as provided in subsection (i), to alter or affect the implementation of any provision of the
p.001131: HIPAA confiden- tiality regulations or section 1176 of the Social Security Act (or regulations promulgated under such
p.001131: section);
p.001131: (4) to limit the authority of any provider, patient safety or- ganization, or other entity to enter into a
p.001131: contract requiring greater confidentiality or delegating authority to make a disclo- sure or use in accordance with
p.001131: this section;
p.001131: (5) as preempting or otherwise affecting any State law re- quiring a provider to report information that is not
p.001131: patient safety work product; or
p.001131: (6) to limit, alter, or affect any requirement for reporting to the Food and Drug Administration
p.001131: information regarding the safety of a product or activity regulated by the Food and Drug Administration.
p.001131: (h) CLARIFICATION.—Nothing in this part prohibits any person from conducting additional analysis for any
p.001131: purpose regardless of whether such additional analysis involves issues identical to or similar to those for
p.001131: which information was reported to or assessed by a patient safety organization or a patient safety evaluation sys- tem.
p.001131: (i) CLARIFICATION OF APPLICATION OF HIPAA CONFIDENTIALITY REGULATIONS TO PATIENT SAFETY
p.001131: ORGANIZATIONS.—For purposes of applying the HIPAA confidentiality regulations—
p.001131: (1) patient safety organizations shall be treated as busi- ness associates; and
p.001131: (2) patient safety activities of such organizations in rela- tion to a provider are deemed to be health care
p.001131: operations (as defined in such regulations) of the provider.
p.001131: (j) REPORTS ON STRATEGIES TO IMPROVE PATIENT SAFETY.—
p.001131: (1) DRAFT REPORT.—Not later than the date that is 18 months after any network of patient safety
p.001131: databases is oper- ational, the Secretary, in consultation with the Director, shall prepare a draft report on
p.001131: effective strategies for reducing med- ical errors and increasing patient safety. The draft report shall include any
...

p.001149:
p.001149:
p.001149: January 30, 2020
p.001149: (e) TRAINING OF RESEARCHERS.—The Agency for Health Care Research and Quality, in consultation with the National
p.001149: Institutes of Health, shall build capacity for comparative clinical effectiveness research by establishing a grant
p.001149: program that provides for the training of researchers in the methods used to conduct such re- search,
p.001149: including systematic reviews of existing research and pri- mary research such as clinical trials. At a minimum,
p.001149: such training shall be in methods that meet the methodological standards adopt- ed under section 1181(d)(9) of the
p.001149: Social Security Act.
p.001149: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001149:
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p.001151: 1151
p.001151: PUBLIC HEALTH SERVICE ACT
p.001151: Sec. 941
p.001151:
p.001151: (f) BUILDING DATA FOR RESEARCH.—The Secretary shall pro- vide for the coordination of relevant Federal
p.001151: health programs to build data capacity for comparative clinical effectiveness research, including the
p.001151: development and use of clinical registries and health outcomes research data networks, in order to develop and maintain
p.001151: a comprehensive, interoperable data network to collect, link, and analyze data on outcomes and
p.001151: effectiveness from multiple sources, including electronic health records.
p.001151: (g) AUTHORITY TO CONTRACT WITH THE INSTITUTE.—Agencies and instrumentalities of the Federal Government may
p.001151: enter into agreements with the Institute, and accept and retain funds, for the conduct and support of research
p.001151: described in this part, provided that the research to be conducted or supported under such agree- ments
p.001151: is authorized under the governing statutes of such agencies and instrumentalities.
p.001151: PART E—GENERAL PROVISIONS
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p.001151: January 30, 2020
p.001151: SEC. 941. ø299c¿ ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.
p.001151: (a) ESTABLISHMENT.—There is established an advisory council to be known as the National Advisory
p.001151: Council for Healthcare Re- search and Quality.
p.001151: (b) DUTIES.—
p.001151: (1) IN GENERAL.—The Advisory Council shall advise the Secretary and the Director with respect to
p.001151: activities proposed or undertaken to carry out the mission of the Agency under section 901(b).
p.001151: (2) CERTAIN RECOMMENDATIONS.—Activities of the Advi- sory Council under paragraph (1) shall include
p.001151: making rec- ommendations to the Director regarding—
p.001151: (A) priorities regarding health care research, espe- cially studies related to quality, outcomes, cost and the
p.001151: uti- lization of, and access to, health care services;
...

p.001153:
p.001153:
p.001153:
p.001153:
p.001153:
p.001153: January 30, 2020
p.001153:
p.001153: individuals who by virtue of their training or experience are eminently qualified to carry out the duties of
p.001153: such peer review group. Officers and employees of the United States may not constitute more than 25 percent of
p.001153: the membership of any such group. Such officers and employees may not receive compensa- tion for service on such groups
p.001153: in addition to the compensation otherwise received for these duties carried out as such officers and employees.
p.001153: (3) DURATION.—Notwithstanding section 14(a) of the Fed- eral Advisory Committee Act, peer review groups
p.001153: established under this section may continue in existence until otherwise provided by law.
p.001153: (4) QUALIFICATIONS.—Members of any peer review group shall, at a minimum, meet the following requirements:
p.001153: (A) Such members shall agree in writing to treat infor- mation received, pursuant to their work for the group,
p.001153: as confidential information, except that this subparagraph shall not apply to public records and public
p.001153: information.
p.001153: (B) Such members shall agree in writing to recuse themselves from participation in the peer review of specific
p.001153: applications which present a potential personal conflict of interest or appearance of such conflict,
p.001153: including employ- ment in a directly affected organization, stock ownership, or any financial or other
p.001153: arrangement that might intro- duce bias in the process of peer review.
p.001153: (d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS IN CERTAIN CASES.—In the case of applications for financial
p.001153: assistance whose direct costs will not exceed $100,000, the Director may make appro- priate adjustments in the
p.001153: procedures otherwise established by the Director for the conduct of peer review under this section. Such ad-
p.001153: justments may be made for the purpose of encouraging the entry of individuals into the field of
p.001153: research, for the purpose of encour- aging clinical practice-oriented or provider-based research, and for
p.001153: such other purposes as the Director may determine to be appro- priate.
p.001153: (e) REGULATIONS.—The Director shall issue regulations for the conduct of peer review under this section.
p.001153: SEC. 943. ø299c–2¿ CERTAIN PROVISIONS WITH RESPECT TO DEVELOP- MENT, COLLECTION, AND DISSEMINATION OF DATA.
p.001153: (a) STANDARDS WITH RESPECT TO UTILITY OF DATA.—
p.001153: (1) IN GENERAL.—To ensure the utility, accuracy, and suffi- ciency of data collected by or for the Agency for the
p.001153: purpose de- scribed in section 901(b), the Director shall establish standard methods for developing and collecting
p.001153: such data, taking into consideration—
p.001153: (A) other Federal health data collection standards; and
p.001153: (B) the differences between types of health care plans, delivery systems, health care providers, and provider
p.001153: ar- rangements.
p.001153: (2) RELATIONSHIP WITH OTHER DEPARTMENT PROGRAMS.—In any case where standards under paragraph (1) may affect
p.001153: the administration of other programs carried out by the Depart- ment of Health and Human Services,
p.001153: including the programs under title XVIII, XIX or XXI of the Social Security Act, or
p.001153: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001153:
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p.001155: 1155
p.001155: PUBLIC HEALTH SERVICE ACT
p.001155: Sec. 944
p.001155:
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p.001155: January 30, 2020
p.001155: may affect health information that is subject to a standard de- veloped under part C of title XI of the Social Security
p.001155: Act, they shall be in the form of recommendations to the Secretary for such program.
p.001155: (b) STATISTICS AND ANALYSES.—The Director shall—
p.001155: (1) take appropriate action to ensure that statistics and analyses developed under this title are of high
p.001155: quality, timely, and duly comprehensive, and that the statistics are specific, standardized, and adequately
p.001155: analyzed and indexed; and
p.001155: (2) publish, make available, and disseminate such statis- tics and analyses on as wide a basis as is
p.001155: practicable.
p.001155: (c) AUTHORITY REGARDING CERTAIN REQUESTS.—Upon request of a public or private entity, the Director may
p.001155: conduct or support research or analyses otherwise authorized by this title pursuant to arrangements under which such
p.001155: entity will pay the cost of the serv- ices provided. Amounts received by the Director under such ar-
p.001155: rangements shall be available to the Director for obligation until expended.
p.001155: SEC. 944. ø299c–3¿ DISSEMINATION OF INFORMATION.
p.001155: (a) IN GENERAL.—The Director shall—
p.001155: (1) without regard to section 501 of title 44, United States Code, promptly publish, make available, and
p.001155: otherwise dis- seminate, in a form understandable and on as broad a basis as practicable so as to maximize its
p.001155: use, the results of research, demonstration projects, and evaluations conducted or sup- ported under
p.001155: this title;
p.001155: (2) ensure that information disseminated by the Agency is science-based and objective and undertakes consultation
p.001155: as necessary to assess the appropriateness and usefulness of the presentation of information that is
p.001155: targeted to specific audi- ences;
p.001155: (3) promptly make available to the public data developed in such research, demonstration projects, and
p.001155: evaluations;
p.001155: (4) provide, in collaboration with the National Library of Medicine where appropriate, indexing, abstracting,
p.001155: translating, publishing, and other services leading to a more effective and timely dissemination of
p.001155: information on research, demonstra- tion projects, and evaluations with respect to health care to public
p.001155: and private entities and individuals engaged in the im- provement of health care delivery and the general
...

p.001159: $136,400,000 for the fiscal year ending September 30, 1978;
p.001159: $200,000,000 for the fiscal year ending September 30, 1979;
p.001159: $230,000,000 for the fiscal year ending September 30, 1980;
p.001159: $264,500,000 for the fiscal year ending September 30, 1981;
p.001159: $126,510,000 for the fiscal year ending September 30, 1982;
p.001159: $139,200,000 for the fiscal year ending September 30, 1983;
p.001159: $150,030,000 for the fiscal year ending September 30, 1984; and
p.001159: $158,400,000 for the fiscal year ending September 30, 1985.
p.001159:
p.001159:
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p.001159: January 30, 2020
p.001159: 1 So in law. See section 931(b)(1) of Public Law 97–35 (95 Stat. 570). Probably should be ‘‘fam- ily’’.
p.001159: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001159:
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p.001159: Sec. 1002 PUBLIC HEALTH SERVICE ACT 1160
p.001159:
p.001159: FORMULA GRANTS TO STATES FOR FAMILY PLANNING SERVICES
p.001159: SEC. 1002. ø300a¿ (a) The Secretary is authorized to make grants, from allotments made under subsection (b),
p.001159: to State health authorities to assist in planning, establishing, maintaining, coordi- nating, and evaluating family
p.001159: planning services. No grant may be made to a State health authority under this section unless such au- thority has
p.001159: submitted, and had approved by the Secretary, a State plan for a coordinated and comprehensive program of
p.001159: family plan- ning services.
p.001159: (b) The sums appropriated to carry out the provisions of this section shall be allotted to the States by the
p.001159: Secretary on the basis of the population and the financial need of the respective States.
p.001159: (c) For the purposes of this section, the term ‘‘State’’ includes the Commonwealth of Puerto Rico, the
p.001159: Northern Mariana Islands, Guam, American Samoa, the Virgin Islands, the District of Colum- bia, and the Trust
p.001159: Territory of the Pacific Islands.
p.001159: (d) For the purpose of making grants under this section, there are authorized to be appropriated $10,000,000 for
p.001159: the fiscal year ending June 30, 1971; $15,000,000 for the fiscal year ending June 30, 1972; and $20,000,000
p.001159: for the fiscal year ending June 30, 1973.
p.001159: TRAINING GRANTS AND CONTRACTS
p.001159: SEC. 1003. ø300a–1¿ (a) The Secretary is authorized to make grants to public or nonprofit private entities and
p.001159: to enter into con- tracts with public or private entities and individuals to provide the training for personnel to
p.001159: carry out family planning service pro- grams described in section 1001 or 1002.
p.001159: (b) For the purpose of making payments pursuant to grants and contracts under this section, there are
p.001159: authorized to be appro- priated $2,000,000 for the fiscal year ending June 30, 1971;
p.001159: $3,000,000 for the fiscal year ending June 30, 1972; $4,000,000 for the fiscal year ending June 30, 1973; and
...

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p.001165: January 30, 2020
p.001165: dence and prevalence of heritable blood disorders, including sickle cell disease, and the geographic
p.001165: distribution of such dis- eases and conditions.
p.001165: (3) APPLICATION.—To seek a grant under this subsection, an eligible entity shall submit an application to
p.001165: the Secretary at such time, in such manner, and containing such information as the Secretary may require.
p.001165: (4) PRIORITY.—In awarding grants under this subsection, the Secretary may give priority, as appropriate, to
p.001165: eligible enti- ties that have a relationship with a community-based organiza- tion that has experience in, or is
p.001165: capable of, providing services to individuals with heritable blood disorders, including sickle cell disease.
p.001165: (5) ELIGIBLE ENTITY.—In this subsection, the term ‘‘eligible entity’’ includes the 50 States, the District of
p.001165: Columbia, the Commonwealth of Puerto Rico, the United States Virgin Is- lands, the Commonwealth of the
p.001165: Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of Marshall
p.001165: Islands, the Republic of Palau, Indian tribes, a State or local health department, an institution of higher
p.001165: education, or a nonprofit entity with appropriate experi- ence to conduct the activities under this subsection.
p.001165: (b) DEMONSTRATION PROGRAM FOR THE DEVELOPMENT AND ES-
p.001165: TABLISHMENT OF SYSTEMIC MECHANISMS FOR THE PREVENTION AND
p.001165: TREATMENT OF SICKLE CELL DISEASE.—
p.001165: (1) AUTHORITY TO CONDUCT DEMONSTRATION PROGRAM.—
p.001165: (A) IN GENERAL.—The Administrator, through the Bu- reau of Primary Health Care and the Maternal and Child Health
p.001165: Bureau, shall continue efforts, including by award- ing grants, to develop or establish mechanisms to improve the
p.001165: treatment of sickle cell disease, and to improve the prevention and treatment of complications of sickle
p.001165: cell disease, in populations with a high proportion of individ- uals with sickle cell disease, including
p.001165: through—
p.001165: (i) the coordination of service delivery for individ- uals with sickle cell disease;
p.001165: (ii) genetic counseling and testing;
p.001165: (iii) bundling of technical services related to the prevention and treatment of sickle cell disease;
p.001165: (iv) training of health professionals; and
p.001165: (v) identifying and establishing other efforts re- lated to the expansion and coordination of education,
p.001165: treatment, and continuity of care programs for individ- uals with sickle cell disease.
p.001165: (B) GEOGRAPHIC DIVERSITY.—The Administrator shall, to the extent practicable, award grants under this
p.001165: section to eligible entities located in different regions of the United States.
p.001165: (2) ADDITIONAL REQUIREMENTS.—An eligible entity award- ed a grant under this subsection shall use
p.001165: funds made avail- able under the grant to carry out, in addition to the activities described in paragraph
p.001165: (1)(A), the following activities:
p.001165: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001165:
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p.001177: assistance under this subsection, he may make grants not to exceed $500,000 to such centers for the purposes of
p.001177: alleviating the insufficiency.
p.001177: (c) No grant or contract may be made under subsection (a) or
p.001177: (b) unless an application therefor has been submitted to and ap- proved by the Secretary. Such an application
p.001177: shall be in such form, submitted in such manner, and contain such information as the Secretary shall by
p.001177: regulation prescribe.
p.001177: (d) Contracts may be entered into under subsection (a) without regard to section 3648 and 3709 of the Revised Statutes
p.001177: (31 U.S.C. 529; 41 U.S.C. 5).
p.001177: (e) For the purpose of making payments under grants and con- tracts under subsections (a) and (b), there are authorized
p.001177: to be ap- propriated $4,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977,
p.001177: $3,450,000 for the fiscal year end- ing September 30, 1978, $2,500,000 for the fiscal year ending Sep- tember 30,
p.001177: 1979, $3,000,000 for the fiscal year ending September 30, 1980, $3,500,000 for the fiscal year ending September
p.001177: 30, 1981.
p.001177: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001179: 1179
p.001179: PUBLIC HEALTH SERVICE ACT
p.001179: Sec. 1202
p.001179:
p.001179: TITLE XII—TRAUMA CARE
p.001179: PART A—GENERAL AUTHORITY AND DUTIES OF SECRETARY
p.001179: SEC. 1201. ø300d¿ ESTABLISHMENT.
p.001179: (a) IN GENERAL.—The Secretary shall, with respect to trauma care—
p.001179: (1) conduct and support research, training, evaluations, and demonstration projects;
p.001179: (2) foster the development of appropriate, modern systems of such care through the sharing of information among
p.001179: agen- cies and individuals involved in the study and provision of such care;
p.001179: (3) collect, compile, and disseminate information on the achievements of, and problems experienced by, State and
p.001179: local agencies and private entities in providing trauma care and emergency medical services and, in so
p.001179: doing, give special con- sideration to the unique needs of rural areas;
p.001179: (4) provide to State and local agencies technical assistance to enhance each State’s capability to develop,
p.001179: implement, and sustain the trauma care component of each State’s plan for the provision of emergency medical services;
p.001179: (5) sponsor workshops and conferences; and
p.001179: (6) promote the collection and categorization of trauma data in a consistent and standardized manner.
p.001179: (b) GRANTS, COOPERATIVE AGREEMENTS, AND CONTRACTS.—The Secretary may make grants, and enter into cooperative
p.001179: agreements and contracts, for the purpose of carrying out subsection (a).
p.001179: SEC. 1202. ø300d–3¿ ESTABLISHMENT OF PROGRAMS FOR IMPROVING TRAUMA CARE IN RURAL AREAS.
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p.001191: January 30, 2020
p.001191:
p.001191: SEC. 1232. ø300d–32¿ FUNDING.
p.001191: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out parts A and B, subject to subsections (b)
p.001191: and (c), there are authorized to be appropriated $24,000,000 for each of fiscal years 2010 through 2014.
p.001191: (b) RESERVATION OF FUNDS.—If the amount appropriated under subsection (a) for a fiscal year is
p.001191: equal to or less than
p.001191: $1,000,000, such appropriation is available only for the purpose of carrying out part A. If the amount so
p.001191: appropriated is greater than
p.001191: $1,000,000, 50 percent of such appropriation shall be made avail- able for the purpose of carrying out part A
p.001191: and 50 percent shall be made available for the purpose of carrying out part B.
p.001191: (c) ALLOCATION OF PART A FUNDS.—Of the amounts appro- priated under subsection (a) for a fiscal year to carry
p.001191: out part A—
p.001191: (1) 10 percent of such amounts for such year shall be allo- cated for administrative purposes; and
p.001191: (2) 10 percent of such amounts for such year shall be allo- cated for the purpose of carrying out section 1202.
p.001191: (d) AUTHORITY.—For the purpose of carrying out parts A through C, beginning on the date of enactment of
p.001191: the Patient Pro- tection and Affordable Care Act, the Secretary shall transfer au- thority in administering
p.001191: grants and related authorities under such parts from the Administrator of the Health Resources and Services
p.001191: Administration to the Assistant Secretary for Preparedness and Re- sponse.
p.001191: PART D—TRAUMA CENTERS OPERATING IN AREAS SEVERELY AFFECTED BY DRUG-RELATED VIOLENCE
p.001191: SEC. 1241. ø300d–41¿ GRANTS FOR CERTAIN TRAUMA CENTERS.
p.001191: (a) IN GENERAL.—The Secretary shall establish 3 programs to award grants to qualified public, nonprofit
p.001191: Indian Health Service, Indian tribal, and urban Indian trauma centers—
p.001191: (1) to assist in defraying substantial uncompensated care costs;
p.001191: (2) to further the core missions of such trauma centers, in- cluding by addressing costs associated with patient
p.001191: stabiliza- tion and transfer, trauma education and outreach, coordination with local and regional trauma systems,
p.001191: essential personnel and other fixed costs, and expenses associated with employee and non-employee physician
p.001191: services; and
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p.001201: January 30, 2020
p.001201: vided to individuals with traumatic brain injury by such sys- tem.
p.001201: (2) REPORT BY SECRETARY.—Not later than 1 year after the date of enactment of the Traumatic Brain Injury Reauthoriza-
p.001201: tion Act of 2014, the Secretary shall prepare and submit to the appropriate committees of Congress a report
p.001201: describing the services and activities carried out under this section during the period for which the report is being
p.001201: prepared.
p.001201: (i) DATA COLLECTION.—The Secretary shall facilitate agree- ments to coordinate the collection of data by
p.001201: agencies within the Department of Health and Human Services regarding protection and advocacy services.
p.001201: (j) TRAINING AND TECHNICAL ASSISTANCE.—
p.001201: (1) GRANTS.—For any fiscal year for which the amount ap- propriated to carry out this section is $6,000,000 or
p.001201: greater, the Secretary shall use 2 percent of such amount to make a grant to an eligible national
p.001201: association for providing for train- ing and technical assistance to protection and advocacy sys- tems.
p.001201: (2) DEFINITION.—In this subsection, the term ‘‘eligible na- tional association’’ means a national
p.001201: association with dem- onstrated experience in providing training and technical assist- ance to protection and
p.001201: advocacy systems.
p.001201: (k) SYSTEM AUTHORITY.—In providing services under this sec- tion, a protection and advocacy system shall
p.001201: have the same au- thorities, including access to records, as such system would have for purposes of
p.001201: providing services under subtitle C of title I of the Developmental Disabilities Assistance and Bill of Rights
p.001201: Act of 2000 (42 U.S.C. 15041 et seq.).
p.001201: (l) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section
p.001201: $4,000,000 for each of fiscal years 2020 through 2024.
p.001201: (m) DEFINITIONS.—In this section:
p.001201: (1) AMERICAN INDIAN CONSORTIUM.—The term ‘‘American Indian consortium’’ means a consortium established under
p.001201: sub- title C of title I of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C.
p.001201: 15041 et seq.).
p.001201: (2) PROTECTION AND ADVOCACY SYSTEM.—The term ‘‘protec- tion and advocacy system’’ means a protection and
p.001201: advocacy system established under subtitle C of title I of the Develop- mental Disabilities Assistance and
p.001201: Bill of Rights Act of 2000 (42 U.S.C. 15041 et seq.).
p.001201: (3) STATE.—The term ‘‘State’’, unless otherwise specified, means the several States of the United States,
p.001201: the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam,
p.001201: American Samoa, and the Com- monwealth of the Northern Mariana Islands.
p.001201: SEC. 1254. ø300d–54¿ STOP, OBSERVE, ASK, AND RESPOND TO HEALTH AND WELLNESS TRAINING PROGRAM.
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p.001203: (1) to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on
p.001203: Health, Edu- cation, Labor, and Pensions of the Senate, together with an es- timate of the funds needed for each
p.001203: of the fiscal years 1994 through 1996 to implement the plan.
p.001203: (c) PARTICIPATING AGENCIES; COORDINATION AND COLLABORA-
p.001203: TION.—The Director—
p.001203: (1) shall provide for the conduct of activities under the Program by the Directors of the agencies of the
p.001203: National Insti- tutes of Health involved in research with respect to trauma;
p.001203: (2) shall ensure that the activities of the Program are co- ordinated among such agencies; and
p.001203: (3) shall, as appropriate, provide for collaboration among such agencies in carrying out such activities.
p.001203: (d) CERTAIN ACTIVITIES OF PROGRAM.—The Program shall in- clude—
p.001203: (1) studies with respect to all phases of trauma care, in- cluding prehospital, resuscitation, surgical
p.001203: intervention, critical care, infection control, wound healing, nutritional care and support, and medical
p.001203: rehabilitation care;
p.001203: (2) basic and clinical research regarding the response of the body to trauma and the acute treatment and
p.001203: medical reha- bilitation of individuals who are the victims of trauma;
p.001203: (3) basic and clinical research regarding trauma care for pediatric and geriatric patients; and
p.001203: (4) the authority to make awards of grants or contracts to public or nonprofit private entities for the conduct of
p.001203: basic and applied research regarding traumatic brain injury, which re- search may include—
p.001203: (A) the development of new methods and modalities for the more effective diagnosis, measurement of degree of
p.001203: brain injury, post-injury monitoring and prognostic assess- ment of head injury for acute, subacute and later
p.001203: phases of care;
p.001203: (B) the development, modification and evaluation of therapies that retard, prevent or reverse brain damage
p.001203: after acute head injury 3, that arrest further deterioration following injury and that provide the
p.001203: restitution of func- tion for individuals with long-term injuries;
p.001203: (C) the development of research on a continuum of care from acute care through rehabilitation, designed,
p.001203: to the extent practicable, to integrate rehabilitation and long- term outcome evaluation with acute care research;
p.001203: (D) the development of programs that increase the participation of academic centers of excellence in brain in-
p.001203:
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p.001203:
p.001203: January 30, 2020
p.001203: 3 Section 1303(a)(2) of Public Law 106–310 (114 Stat. 1138) provides that subparagraph (B) is amended by
p.001203: striking ‘‘acute injury’’ and inserting ‘‘acute brain injury’’. The amendment cannot be executed because the term
p.001203: to be struck does not appear in subparagraph (B). (Compare ‘‘acute injury’’ and ‘‘acute head injury’’.)
p.001203: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001219: organization, determines is unusual and infrequently provided and not necessary for the pro- tection of individual
p.001219: health. The Secretary shall publish in the Fed- eral Register each determination made by him under the preceding
p.001219: sentence. If a service of a physician described in the preceding sen- tence may also be provided under applicable State
p.001219: law by a dentist, optometrist, podiatrist, psychologist, or other health care personnel a health maintenance
p.001219: organization may provide such service through a dentist, optometrist, podiatrist, psychologist, or other
p.001219: health care personnel (as the case may be) licensed to provide such
p.001219: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001219: Sec. 1302 PUBLIC HEALTH SERVICE ACT 1220
p.001219:
p.001219: service. Such term includes a health service directly associated with an organ transplant only if such
p.001219: organ transplant was re- quired to be included in basic health services on April 15, 1985. For purposes of this
p.001219: paragraph, the term ‘‘home health services’’ means health services provided at a member’s home by health care
p.001219: per- sonnel, as prescribed or directed by the responsible physician or other authority designated by the
p.001219: health maintenance organization.
p.001219: (2) The term ‘‘supplemental health services’’ means any health service which is not included as a basic health service
p.001219: under para- graph (1) of this section. If a health service provided by a physician may also be provided under
p.001219: applicable State law by a dentist, op- tometrist, podiatrist, psychologist, or other health care
p.001219: personnel, a health maintenance organization may provide such service through an optometrist, dentist,
p.001219: podiatrist, psychologist, or other health care personnel (as the case may be) licensed to provide such service.
p.001219: (3) The term ‘‘member’’ when used in connection with a health maintenance organization means an individual who
p.001219: has entered into a contractual agreement, or on whose behalf a contractual ar- rangement has been entered into,
p.001219: with the organization under which the organization assumes the responsibility for the provision to such individual
p.001219: of basic health services and of such supple- mental health services as may be contracted for.
p.001219: (4) The term ‘‘medical group’’ means a partnership, association, or other group—
p.001219: (A) which is composed of health professionals licensed to practice medicine or osteopathy and of such
p.001219: other licensed health professionals (including dentists, optometrists, podia- trists, and psychologists) as
p.001219: are necessary for the provision of health services for which the group is responsible;
p.001219: (B) a majority of the members of which are licensed to practice medicine or osteopathy; and
p.001219: (C) the members of which (i) as their principal professional activity engage in the coordinated practice of
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p.001221: services by individuals and families, the Secretary shall disapprove such factor for such purpose. If a
p.001221: health maintenance organization is to fix rates of payment for a group under clause (ii), it shall,
p.001221: upon request of the entity with which it contracts to provide services to such group, disclose to that entity the
p.001221: method and data used in calculating the rates of pay- ment.
p.001221: (D) The following differentials in rates of payments may be es- tablished under the systems described in
p.001221: subparagraphs (B) and (C):
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p.001221: (i) Nominal differentials in such rates may be established to reflect differences in marketing costs and
p.001221: the different ad- ministrative costs of collecting payments from the following categories of members:
p.001221: (I) Individual members (including their families).
p.001221: (II) Small groups of members (as determined under regulations of the Secretary).
p.001221: (III) Large groups of members (as determined under regulations of the Secretary).
p.001221: (ii) Nominal differentials in such rates may be established to reflect the compositing of the rates of payment in a
p.001221: system- atic manner to accommodate group purchasing practices of the various employers.
p.001221: (iii) Differentials in such rates may be established for members enrolled in a health maintenance organization
p.001221: pursu- ant to a contract with a governmental authority under section 1079 or 1086 of title 10, United States
p.001221: Code, or under any other governmental program (other than the health benefits program authorized by
p.001221: chapter 89 of title 5, United States Code) or any health benefits program for employees of States,
p.001221: political subdivision of States, and other public entities.
p.001221: (9) The term ‘‘non-metropolitan area’’ means an area no part of which is within an area designated as
p.001221: a standard metropolitan
p.001221: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001223: PUBLIC HEALTH SERVICE ACT
p.001223: Sec. 1305
p.001223:
p.001223: statistical area by the Office of Management and Budget and which does not contain a city whose population exceeds
p.001223: fifty thousand in- dividuals.
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p.001235: necessary. An internship provided an indi- vidual for training at a health maintenance organization or
p.001235: any other entity shall also provide for payments to be made to the orga- nization or other entity for the cost
p.001235: of support services (including the cost of salaries, supplies, equipment, and related items) pro- vided
p.001235: such individual by such organization or other entity. The amount of any such payments to any
p.001235: organization or other entity shall be determined by the Secretary and shall bear a direct rela- tionship
p.001235: to the reasonable costs of the organization or other entity for establishing and maintaining its training programs.
p.001235: (4) Payments under grants under the Program may be made in advance or by way of reimbursement, and at such
p.001235: intervals and on such conditions, as the Secretary finds necessary.
p.001235: (b) The Secretary shall provide technical assistance (1) to enti- ties intending to become a qualified health
p.001235: maintenance organiza- tion within the meaning of section 1310(d), and (2) to health main-
p.001235: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001235: Sec. 1318 PUBLIC HEALTH SERVICE ACT 1236
p.001235:
p.001235: tenance organizations. The Secretary may provide such technical assistance through grants to public and
p.001235: nonprofit private entities and contracts with public and private entities.
p.001235: (c) The authority of the Secretary to enter into contracts under subsections (a) and (b) shall be effective for any
p.001235: fiscal year only to such extent or in such amounts as are provided in advance by ap- propriation Acts.
p.001235: FINANCIAL DISCLOSURE
p.001235: SEC. 1318. ø300e–17¿ (a) Each health maintenance organiza- tion shall, in accordance with regulations of
p.001235: the Secretary, report to the Secretary financial information which shall include the fol- lowing:
p.001235: (1) Such information as the Secretary may require dem- onstrating that the health maintenance organization has
p.001235: a fis- cally sound operation.
p.001235: (2) A copy of the report, if any, filed with the Centers for Medicare & Medicaid Services containing
p.001235: the information re- quired to be reported under section 1124 of the Social Security Act by disclosing entities
p.001235: and the information required to be supplied under section 1902(a)(38) of such Act.
p.001235: (3) A description of transactions, as specified by the Sec- retary, between the health maintenance
p.001235: organization and a party in interest. Such transactions shall include—
p.001235: (A) any sale or exchange, or leasing of any property between the health maintenance organization and a party
p.001235: in interest;
p.001235: (B) any furnishing for consideration of goods, services (including management services), or facilities
p.001235: between the health maintenance organization and a party in interest, but not including salaries paid to
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p.001237: (A) is an officer or director;
p.001237: (B) is a partner (if such entity is organized as a part- nership);
p.001237: (C) has directly or indirectly a beneficial interest of more than 5 per centum of the equity; or
p.001237: (D) has a mortgage, deed of trust, note, or other inter- est valuing more than 5 per centum of the assets of
p.001237: such entity;
p.001237: (3) any person directly or indirectly controlling, controlled by, or under common control with a health
p.001237: maintenance orga- nization; and
p.001237: (4) any spouse, child, or parent of an individual described in paragraph (1).
p.001237: (c) Each health maintenance organization shall make the infor- mation reported pursuant to subsection (a) available to
p.001237: its enrollees upon reasonable request.
p.001237: (d) The Secretary shall, as he deems necessary, conduct an evaluation of transactions reported to the
p.001237: Secretary under sub- section (a)(3) for the purpose of determining their adverse impact, if any, on the
p.001237: fiscal soundness and reasonableness of charges to the health maintenance organization with respect to which they
p.001237: tran- spired. The Secretary shall evaluate the reported transactions of not less than five, or if there are
p.001237: more than twenty health mainte- nance organizations reporting such transactions, not less than one- fourth of the
p.001237: health maintenance organizations reporting any such transactions under subsection (a)(3).
p.001237: (f) 4 Nothing in this section shall be construed to confer upon the Secretary any authority to approve
p.001237: or disapprove the rates charged by any health maintenance organization.
p.001237: (g) Any health maintenance organization failing to file with the Secretary the annual financial statement required in
p.001237: subsection (a) shall be ineligible for any Federal assistance under this title until such time as such
p.001237: statement is received by the Secretary and shall not be a qualified health maintenance organization for purposes of
p.001237: section 1310.
p.001237: (h) Whoever knowingly and willfully makes or causes to be made any false statement or representation of
p.001237: a material fact in any statement filed pursuant to this section shall be guilty of a fel- ony and upon conviction
p.001237: thereof shall be fined not more than
p.001237: $25,000 or imprisoned for not more than five years, or both.
p.001237: TITLE XIV—SAFETY OF PUBLIC WATER SYSTEMS
p.001237:
p.001237: øFor Text of This Title See Volume 2 of the Environmental Law Compilation¿
p.001237:
p.001237:
p.001237:
p.001237: January 30, 2020
p.001237: 4 Subsection (e) was repealed by section 810 of Public Law 99–660.
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001237:
p.001237:
p.001237:
p.001237:
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p.001237:
p.001237: Sec. 1501 PUBLIC HEALTH SERVICE ACT 1238
p.001237: TITLE XV—PREVENTIVE HEALTH MEAS- URES WITH RESPECT TO BREAST AND CERVICAL CANCERS
p.001237:
p.001237: SEC. 1501. ø300k¿ ESTABLISHMENT OF PROGRAM OF GRANTS TO STATES.
p.001237: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make
p.001237: grants to States on the basis of an established competitive review process for the purpose of carrying out programs—
p.001237: (1) to screen women for breast and cervical cancer as a preventive health measure;
p.001237: (2) to provide appropriate referrals for medical treatment of women screened pursuant to paragraph (1)
p.001237: and to ensure, to the extent practicable, the provision of appropriate follow-up services and support services such
p.001237: as case management;
p.001237: (3) to develop and disseminate public information and edu- cation programs for the detection and control of breast and
p.001237: cer- vical cancer;
p.001237: (4) to improve the education, training, and skills of health professionals (including allied health professionals)
p.001237: in the de- tection and control of breast and cervical cancer;
p.001237: (5) to establish mechanisms through which the States can monitor the quality of screening procedures for breast and
p.001237: cer- vical cancer, including the interpretation of such procedures; and
p.001237:
p.001237:
p.001237:
p.001237:
p.001237:
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p.001237:
p.001237:
p.001237:
p.001237: January 30, 2020
p.001237: (6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or
p.001237: program-moni- toring activities.
p.001237: (b) GRANT AND CONTRACT AUTHORITY OF STATES.—
p.001237: (1) IN GENERAL.—A State receiving a grant under sub- section (a) may, subject to paragraphs (2) and
p.001237: (3), expend the grant to carry out the purpose described in such subsection through grants to public and
p.001237: nonprofit private entities and through contracts with public and private entities.
p.001237: (2) CERTAIN APPLICATIONS.—If a nonprofit private entity and a private entity that is not a nonprofit entity
p.001237: both submit applications to a State to receive an award of a grant or con- tract pursuant to paragraph (1),
p.001237: the State may give priority to the application submitted by the nonprofit private entity in any case in
p.001237: which the State determines that the quality of such application is equivalent to the quality of the application
p.001237: submitted by the other private entity.
p.001237: (3) PAYMENTS FOR SCREENINGS.—The amount paid by a State to an entity under this subsection for a screening
p.001237: proce- dure under subsection (a)(1) may not exceed the amount that would be paid under part B of title XVIII
p.001237: of the Social Security Act if payment were made under such part for furnishing the procedure to a woman
p.001237: enrolled under such part.
p.001237: (c) SPECIAL CONSIDERATION FOR CERTAIN STATES.—In making grants under subsection (a) to States whose
p.001237: initial grants under such subsection are made for fiscal year 1995 or any subsequent fiscal year, the
p.001237: Secretary shall give special consideration to any
p.001237: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001237:
p.001237:
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p.001247: (1) IN GENERAL.—Subject to paragraph (2), for the purpose of carrying out this section, there are authorized
p.001247: to be appro- priated $3,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years
p.001247: 1995 through 2003.
p.001247: (2) LIMITATION REGARDING FUNDING WITH RESPECT TO BREAST AND CERVICAL CANCER.—The authorization
p.001247: of appro- priations established in paragraph (1) is not effective for a fis- cal year unless the amount appropriated
p.001247: under section 1510(a) for the fiscal year is equal to or greater than $100,000,000.
p.001247: SEC. 1510. ø300n–5¿ FUNDING FOR GENERAL PROGRAM.
p.001247: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this title, there are authorized to
p.001247: be appropriated
p.001247: $50,000,000 for fiscal year 1991, such sums as may be necessary for each of the fiscal years 1992 and
p.001247: 1993, $150,000,000 for fiscal year 1994, such sums as may be necessary for each of the fiscal years
p.001247: 1995 through 2003, $225,000,000 for fiscal year 2008,
p.001247: $245,000,000 for fiscal year 2009, $250,000,000 for fiscal year 2010,
p.001247: $255,000,000 for fiscal year 2011, and $275,000,000 for fiscal year 2012.
p.001247: (b) SET-ASIDE FOR TECHNICAL ASSISTANCE AND PROVISION OF SUPPLIES AND SERVICES.—Of the amounts appropriated under
p.001247: sub- section (a) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out
p.001247: section 1507.
p.001247: TITLE XVI—HEALTH RESOURCES DEVELOPMENT PART A—LOANS AND LOAN GUARANTEES
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247:
p.001247: January 30, 2020
p.001247: AUTHORITY FOR LOANS AND LOAN GUARANTEES
p.001247: SEC. 1601. ø300q¿ (a)(1) The Secretary, during the period end- ing September 30, 1982, may, in accordance with
p.001247: this part, make loans from the fund established under section 1602(d) to any public or nonprofit private entity for
p.001247: projects for—
p.001247: (A) the discontinuance of unneeded hospital services or fa- cilities;
p.001247: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001247:
p.001247:
p.001247:
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p.001247:
p.001247: Sec. 1602 PUBLIC HEALTH SERVICE ACT 1248
p.001247:
p.001247: (B) the conversion of unneeded hospital services and facili- ties to needed health services and medical
p.001247: facilities, including outpatient medical facilities and facilities for long-term care;
p.001247: (C) the renovation and modernization of medical facilities, particularly projects for the prevention or elimination of
p.001247: safety hazards, projects to avoid noncompliance with licensure or ac- creditation standards, or projects to
p.001247: replace obsolete facilities;
p.001247: (D) the construction of new outpatient medical facilities;
p.001247: and
p.001247: (E) the construction of new inpatient medical facilities in
p.001247: areas which have experienced (as determined by the Secretary) recent rapid population growth.
p.001247: (2)(A) The Secretary, during the period ending September 30, 1982, may, in accordance with this part, guarantee
p.001247: to—
p.001247: (i) non-Federal lenders for their loans to public and non- profit private entities for medical facilities
...

p.001251: made or guaranteed under this part or under title VI, in- cluding selling real property pledged as security for such a
p.001251: loan or loan guarantee and for a reasonable period of time taking posses- sion of, holding, and using
p.001251: real property pledged as security for such a loan or loan guarantee.
p.001251: PART B—PROJECT GRANTS
p.001251:
p.001251:
p.001251:
p.001251:
p.001251:
p.001251: January 30, 2020
p.001251: PROJECT GRANTS
p.001251: SEC. 1610. ø300r¿ (a)(1)(A) The Secretary may make grants for construction or modernization projects designed to—
p.001251: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001251:
p.001251:
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p.001251:
p.001251:
p.001253: 1253
p.001253: PUBLIC HEALTH SERVICE ACT
p.001253: Sec. 1610
p.001253:
p.001253: (i) eliminate or prevent in medical facilities imminent safe- ty hazards as defined by Federal, State, or local fire,
p.001253: building, or life safety codes or regulations, or
p.001253: (ii) avoid noncompliance by medical facilities with State or voluntary licensure or accreditation standards.
p.001253: (B) A grant under subparagraph (A) may only be made to—
p.001253: (i) a State or political subdivision of a State, including any city, town, county, borough, hospital district
p.001253: authority, or pub- lic or quasi-public corporation, for any medical facility owned or operated by the State or
p.001253: political subdivision; and
p.001253: (ii) a nonprofit private entity for any medical facility owned or operated by the entity but only if
p.001253: the Secretary deter- mines—
p.001253:
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p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253:
p.001253: January 30, 2020
p.001253: (I) the level of community service provided by the fa- cility and the proportion of its patients who are
p.001253: unable to pay for services rendered in the facility is similar to such level and proportion in a medical
p.001253: facility of a State or po- litical subdivision, and
p.001253: (II) that without a grant under subparagraph (A) there would be a disruption of the provision of health
p.001253: care to low-income individuals.
p.001253: (2) The amount of any grant under paragraph (1) may not ex- ceed 75 per centum of the cost of the project for
p.001253: which the grant is made unless the project is located in an area determined by the Secretary to be an urban or
p.001253: rural poverty area, in which case the grant may cover up to 100 per centum of such costs.
p.001253: (3) There are authorized to be appropriated for grants under paragraph (1) $40,000,000 for the fiscal year
...

p.001255: health care in the health service area in which such service was provided or facility located;
p.001255: (D) a description of the site of such project;
p.001255: (E) plans and specifications therefor which meet the re- quirements of the regulations prescribed under section
p.001255: 1620(2);
p.001255: (F) reasonable assurance that title to such site is or will be vested in one or more of the entities
p.001255: filing the application or in a public or other nonprofit entity which is to operate the facility on completion of the
p.001255: project;
p.001255: (G) reasonable assurance that adequate financial support will be available for the completion of the
p.001255: project and for its maintenance and operation when completed, and, for the pur- pose of determining if
p.001255: the requirements of this subparagraph are met, Federal assistance provided directly to a medical facil- ity which
p.001255: is located in an area determined by the Secretary to be an urban or rural poverty area or through benefits provided
p.001255: individuals served at such facility shall be considered as finan- cial support;
p.001255: (H) the type of assistance being sought under part A or B for the project;
p.001255: (I) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the
p.001255: performance of work on a project will be paid wages at rates not less than those prevailing on similar
p.001255: construction in the locality as de- termined by the Secretary of Labor in accordance with the Act of March 3,
p.001255: 1931 (40 U.S.C. 276a—276a–5, known as the Davis-Bacon Act), and the Secretary of Labor shall have with
p.001255: respect to such labor standards the authority and functions set forth in Reorganization Plan Numbered 14 of 1950
p.001255: (15 FR 3176; 5 U.S.C. Appendix) and section 2 of the Act of June 13, 1934 (40 U.S.C. 276c);
p.001255: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001255:
p.001255:
p.001255:
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p.001255:
p.001255: Sec. 1622 PUBLIC HEALTH SERVICE ACT 1256
p.001255:
p.001255: (J) in the case of a project for the construction or mod- ernization of an outpatient facility,
p.001255: reasonable assurance that the services of a general hospital will be available to patients at such facility
p.001255: who are in need of hospital care; and
p.001255: (K) reasonable assurance that at all times after such appli- cation is approved (i) the facility or portion
p.001255: thereof to be con- structed, modernized, or converted will be made available to all persons residing or employed in
p.001255: the area served by the facility, and (ii) there will be made available in the facility or portion thereof
p.001255: to be constructed, modernized, or converted a reason- able volume of services to persons unable to pay
p.001255: therefor and the Secretary, in determining the reasonableness of the volume of services provided, shall take into
p.001255: consideration the extent to which compliance is feasible from a financial viewpoint.
p.001255: (2)(A) The Secretary may waive—
p.001255: (i) the requirements of subparagraph (D) of paragraph (1) for compliance with modernization and equipment
p.001255: standards prescribed pursuant to section 1620(2), and
...

p.001263: (C) an estimate of the change in the applicant’s costs which will result from such discontinuance and
p.001263: conversion; and
p.001263: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001263:
p.001263:
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p.001263:
p.001263: Sec. 1642 PUBLIC HEALTH SERVICE ACT 1264
p.001263:
p.001263:
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p.001263: January 30, 2020
p.001263:
p.001263: (D) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the
p.001263: performance of work on a project will be paid wages at rates not less than those prevailing on similar
p.001263: construction in the locality as de- termined by the Secretary of Labor in accordance with the Act of March 3,
p.001263: 1931 (40 U.S.C. 276a—276a–5, known as the Davis-Bacon Act), and the Secretary of Labor shall have with
p.001263: respect to such labor standards the authority and functions set forth in Reorganization Plan Numbered 14 of 1950
p.001263: (15 FR 3176; 5 U.S.C. Appendix) and section 2 of the Act of June 13, 1934 (40 U.S.C. 276c);
p.001263: (E) such other information as the Secretary may require. (2)(A) The health systems agency for the health
p.001263: service area in which is located a hospital applying for a grant under the program shall (i) in making the review
p.001263: of the applicant’s application under section 1513(e), determine the need for each service or part pro-
p.001263: posed to be discontinued by the applicant, (ii) in the case of an ap- plication for the conversion of a facility,
p.001263: determine the need for each service which will be provided as a result of a conversion, and
p.001263: (iii) make a recommendation to the State Agency for the State in which the applicant is located respecting
p.001263: approval by the Secretary of the applicant’s application.
p.001263: (B) A State Agency which has received a recommendation from a health systems agency under subparagraph (A) respecting
p.001263: an ap- plication shall, after consideration of such recommendation, make a recommendation to the Secretary
p.001263: respecting the approval by the Secretary of the application. A State Agency’s recommendation under this
p.001263: subparagraph respecting the approval of an application
p.001263: (i) shall be based upon (I) the need for each service or part pro- posed to be discontinued by the
p.001263: applicant, (II) in the case of an ap- plication for the conversion of a facility, the need for each service
p.001263: which will be provided as a result of the conversion, and (III) such other criteria as the Secretary may
p.001263: prescribe, and (ii) shall be ac- companied by the health systems agency’s recommendation made with respect
...

p.001265: (3) developing programs to reduce excess hospital capacity in a manner which will produce the greatest savings
p.001265: in the cost of health care delivery,
p.001265: (4) developing means to overcome barriers to the reduction of excess hospital capacity,
p.001265: (5) in planning, evaluating, and carrying out programs to decertify health care facilities providing
p.001265: health services that are not appropriate, and
p.001265: (6) any other activity related to the reduction of excess hospital capacity.
p.001265: (b) Grants under subsection (a) shall be made on such terms and conditions as the Secretary may prescribe.
p.001265: AUTHORIZATION OF APPROPRIATIONS
p.001265: SEC. 1644. ø300t–14¿ To make payments under grants under sections 1642 and 1643 there are authorized to
p.001265: be appropriated
p.001265: $30,000,000 for the fiscal year ending September 30, 1980,
p.001265: $50,000,000 for the fiscal year ending September 30, 1981, and
p.001265: $75,000,000 for the fiscal year ending September 30, 1982, except that in any fiscal year not more than 10
p.001265: percent of the amount ap- propriated under this section may be obligated for grants under section 1643.
p.001265: TITLE XVII—HEALTH INFORMATION AND HEALTH PROMOTION
p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
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p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
p.001265:
p.001265: January 30, 2020
p.001265: GENERAL AUTHORITY
p.001265: SEC. 1701. ø300u¿ (a) The Secretary shall—
p.001265: (1) formulate national goals, and a strategy to achieve such goals, with respect to health information and
p.001265: health pro- motion, preventive health services, and education in the appro- priate use of health care;
p.001265: (2) analyze the necessary and available resources for im- plementing the goals and strategy
p.001265: formulated pursuant to paragraph (1), and recommend appropriate educational and quality assurance policies
p.001265: for the needed manpower resources identified by such analysis;
p.001265: (3) undertake and support necessary activities and pro- grams to—
p.001265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001265:
p.001265:
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p.001265:
p.001265:
p.001267: 1267
p.001267: PUBLIC HEALTH SERVICE ACT
p.001267: Sec. 1701
p.001267:
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p.001267: January 30, 2020
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p.001283: Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral
p.001283: research. Each such report shall in- clude a review of the adequacy and uniformity (1) of the rules, poli- cies,
p.001283: guidelines, and regulations of all Federal agencies regarding the protection of human subjects of
p.001283: biomedical or behavioral re- search which such agencies conduct or support, and (2) of the im-
p.001283: plementation of such rules, policies, guidelines, and regulations by such agencies, and may include such
p.001283: recommendations for legisla- tion and administrative action as the Commission deems appro- priate.
p.001283: (d) ANNUAL REPORT.—Not later than December 15 of each year (beginning with 1979) the Commission shall report to
p.001283: the Presi- dent, the Congress, and appropriate Federal agencies on the activi- ties of the Commission during the
p.001283: fiscal year ending in such year. Each such report shall include a complete list of all recommenda- tions
p.001283: described in subsection (b)(1) made to Federal agencies by the Commission during the fiscal year and the actions taken,
p.001283: pursant 4 to subsection (b)(2), by the agencies upon such recommendations, and may include such recommendations
p.001283: for legislation and admin- istrative action as the Commission deems appropriate.
p.001283: (e) PUBLICATIONS.—The Commission may at any time publish and disseminate to the public reports respecting its
p.001283: activities.
p.001283: (f) DEFINITIONS.—For purposes of this section:
p.001283: (1) The term ‘‘Federal agency’’ means an authority of the government of the United States, but does not
p.001283: include (A) the Congress, (B) the courts of the United States, and (C) the gov- ernment of the Commonwealth of
p.001283: Puerto Rico, the government of the District of Columbia, or the government of any territory or possession of the United
p.001283: States.
p.001283: (2) The term ‘‘protection of human subjects’’ includes the protection of the health, safety, and privacy of
p.001283: individuals.
p.001283: ADMINISTRATIVE PROVISIONS
p.001283: SEC. 1803. ø300v–2¿ (a) HEARINGS.—The Commission may for the purpose of carrying out this title hold such
p.001283: hearings, sit and act at such times and places, take such testimony, and receive such evidence, as the Commission
p.001283: may deem advisable.
p.001283: (b) STAFF.—(1) The Commission may appoint and fix the pay of such staff personnel as it deems desirable. Such
p.001283: personnel shall be appointed subject to the provisions of title 5, United States Code, governing appointments
p.001283: in the competitive service, and shall be paid in accordance with the provisions of chapter 51 and sub-
p.001283: chapter III of chapter 53 of such title relating to classification and General Schedule pay rates.
p.001283:
p.001283:
p.001283:
p.001283: January 30, 2020
p.001283: 4 So in law. Probably should be ‘‘pursuant’’.
p.001283: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001283:
p.001283:
p.001283:
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p.001283:
p.001283: Sec. 1804 PUBLIC HEALTH SERVICE ACT 1284
p.001283:
p.001283: (2) The Commission may procure temporary and intermittent services to the same extent as is authorized
p.001283: by section 3109(b) of title 5 of the United States Code, but at rates for individuals not to exceed
p.001283: the daily equivalent of the annual rate of basis pay in effect for grade GS–18 of the General Schedule.
p.001283: (3) Upon request of the Commission, the head of any Federal agency is authorized to detail, on a reimbursable
p.001283: basis, any of the personnel of such agency to the Commission to assist it in carrying out its duties under this title.
p.001283: (c) CONTRACTS.—The Commission, in performing its duties and functions under this title, may enter into contracts
p.001283: with appro- priate public or nonprofit private entities. The authority of the Commission to enter into
p.001283: such contracts is effective for any fiscal year only to such extent or in such amounts as are provided in ad-
p.001283: vance in appropriation Acts.
p.001283: (d) INFORMATION.—(1) The Commission may secure directly from any Federal agency information necessary to
p.001283: enable it to carry out this title. Upon request of the Chairman of the Commis- sion, the head of such agency shall
p.001283: furnish such information to the Commission.
p.001283: (2) The Commission shall promptly arrange for such security clearances for its members and appropriate
p.001283: staff as are necessary to obtain access to classified information needed to carry out its du- ties under this title.
p.001283: (3) The Commission shall not disclose any information reported to or otherwise obtained by the Commission which is
p.001283: exempt from disclosure under subsection (a) of section 552 of title 5, United States Code, by reason of
p.001283: paragraphs (4) and (6) of subsection (b) of such section.
p.001283: (e) SUPPORT SERVICES.—The Administrator of General Services shall provide to the Commission on a reimbursable
p.001283: basis such ad- ministrative support services as the Commission may request.
p.001283: AUTHORIZATION OF APPROPRIATIONS; TERMINATION OF COMMISSION
p.001283: SEC. 1804. ø300v–3¿ (a) AUTHORIZATIONS.—To carry out this title there are authorized to be appropriated
p.001283: $5,000,000 for the fis- cal year ending September 30, 1979, $5,000,000 for the fiscal year ending September
p.001283: 30, 1980, $5,000,000 for the fiscal year ending September 30, 1981, and $5,000,000 for the fiscal year ending
p.001283: Sep- tember 30, 1982.
...

p.001283:
p.001283:
p.001283:
p.001283:
p.001283:
p.001283: January 30, 2020
p.001283: AUTHORIZATION OF APPROPRIATIONS
p.001283: SEC. 1901. ø300w¿ (a) For the purpose of allotments under sec- tion 1902, there are authorized to be appropriated
p.001283: $205,000,000 for
p.001283: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001283:
p.001283:
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p.001283:
p.001283:
p.001285: 1285
p.001285: PUBLIC HEALTH SERVICE ACT
p.001285: Sec. 1902
p.001285:
p.001285: fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
p.001285: (b) Of the amount appropriated for any fiscal year under sub- section (a), at least $7,000,000 shall be
p.001285: made available for allot- ments under section 1902(b).
p.001285: ALLOTMENTS
p.001285: SEC. 1902. ø300w–1¿ (a)(1) From the amounts appropriated under section 1901 for any fiscal year and
p.001285: available for allotment under this subsection, the Secretary shall allot to each State an amount which
p.001285: bears the same ratio to the available amounts for that fiscal year as the amounts provided by the
p.001285: Secretary under the provisions of law listed in paragraph (2) to the State and enti- ties in the State for fiscal
p.001285: year 1981 bore to the total amount ap- propriated for such provisions of law for fiscal year 1981.
p.001285: (2) The provisions of law referred to in paragraph (1) are the following provisions of law as in effect on
p.001285: September 30, 1981:
p.001285: (A) The authority for grants under section 317 for preven- tive health service programs for the control of rodents.
p.001285: (B) The authority for grants under section 317 for estab- lishing and maintaining community and school-based
p.001285: fluorida- tion programs.
p.001285: (C) The authority for grants under section 317 for preven- tive health service programs for hypertension.
p.001285: (D) Sections 401 and 402 of the Health Services and Cen- ters Amendments of 1978.
p.001285: (E) Section 314(d).
p.001285: (F) Section 339(a).
p.001285: (G) Sections 1202, 1203, and 1204.
p.001285: (b) From the amount required to be made available under sec- tion 1901(b) for allotments under this subsection
p.001285: for any fiscal year, the Secretary shall make allotments to each State on the basis of the population of
p.001285: the State.
p.001285: (c) To the extent that all the funds appropriated under section 1901 for a fiscal year and available for allotment in
p.001285: such fiscal year are not otherwise allotted to States because—
p.001285: (1) one or more States have not submitted an application or description of activities in accordance with
p.001285: section 1905 for the fiscal year;
p.001285: (2) one or more States have notified the Secretary that they do not intend to use the full amount of
p.001285: their allotment; or
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285:
p.001285: January 30, 2020
p.001285: (3) some State allotments are offset or repaid under sec- tion 1906(b)(3);
p.001285: such excess shall be allotted among each of the remaining States in proportion to the amount otherwise
p.001285: allotted to such States for the fiscal year without regard to this subsection.
p.001285: (d)(1) If the Secretary—
p.001285: (A) receives a request from the governing body of an In- dian tribe or tribal organization within any
p.001285: State that funds under this part be provided directly by the Secretary to such tribe or organization, and
p.001285: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001285:
p.001285:
...

p.001315: retary.
p.001315: (ii) STATE EXPENDITURES.—For a fiscal year in which a State commits funds as described in clause (i), such State
p.001315: shall maintain State expenditures for to- bacco prevention programs and for compliance activi- ties at a
p.001315: level that is not less than the level of such expenditures maintained by the State for the pre- ceding
p.001315: fiscal year, plus the additional funds for tobacco compliance activities required under clause (i). The State
p.001315: shall submit a report to the Secretary on all State obligations of funds for such fiscal year and all
p.001315: State expenditures for the preceding fiscal year for to- bacco prevention and compliance activities by program activity
p.001315: by July 31 of such fiscal year.
p.001315: (iii) DISCRETION.—The Secretary shall exercise discretion in enforcing the timing of the State obliga-
p.001315: tion of the additional funds required by the certifi- cation described in subparagraph (A)(i) as late as July
p.001315: 31 of such fiscal year.
p.001315: (C) FAILURE TO CERTIFY.—If a State described in sub- paragraph (A) fails to certify to the Secretary pursuant
p.001315: to subparagraph (A)(i) or enter into, or comply with, a nego- tiated agreement under subparagraph (A)(ii), the
p.001315: Secretary may take action pursuant to paragraph (1).
p.001315: (c) IMPLEMENTATION OF REPORTING REQUIREMENTS.—
p.001315: (1) TRANSITION PERIOD.—The Secretary shall—
p.001315: (A) not withhold amounts under subsection (b) for the 3-year period immediately following the date of enactment of
p.001315: division N of the Further Consolidated Appropriations Act, 2020; and
p.001315: (B) use discretion in exercising its authority under subsection (b) during the 2-year period immediately
p.001315: fol- lowing the 3-year period described in subparagraph (A), to allow for a transition period for implementation
p.001315: of the re- porting requirements under subsection (a)(2).
p.001315: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001315:
p.001315:
p.001315:
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p.001315:
p.001315: Sec. 1927 PUBLIC HEALTH SERVICE ACT 1316
p.001315:
p.001315:
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p.001315:
p.001315:
p.001315: January 30, 2020
p.001315:
p.001315: (2) REGULATIONS OR GUIDANCE.—Not later than 180 days after the date of enactment of division N of the
p.001315: Further Con- solidated Appropriations Act, 2020, the Secretary shall update regulations under part 96 of title
p.001315: 45, Code of Federal Regula- tions or guidance on the retailer compliance rate goal under subsection (b),
p.001315: the use of funds provided under section 1921 for purposes of meeting the requirements of this section, and re-
...

p.001321: (vi) provides a description of the financial re- sources available;
p.001321: (vii) describes the existing substance use disorders workforce and workforce trained in treating co-occur- ring
p.001321: substance use and mental disorders;
p.001321: (viii) includes a description of how the State pro- motes evidence-based practices; and
p.001321: (ix) describes how the State integrates substance use disorder services and primary health care, which in
p.001321: the case of those individuals with co-occurring men- tal health and substance use disorders may include
p.001321: providing both mental health and substance use dis- order services in primary care settings or providing
p.001321: primary and specialty care services in community- based mental health and substance use disorder serv- ice
p.001321: settings.
p.001321: (B) The establishment of goals and objectives for the period of the plan, including targets and
p.001321: milestones that are intended to be met, and the activities that will be un- dertaken to achieve those targets.
p.001321: (C) A description of how the State will comply with each funding agreement for a grant under section
p.001321: 1921 that is applicable to the State, including a description of the manner in which the State intends
p.001321: to expend grant funds.
p.001321: (2) MODIFICATIONS.—
p.001321: (A) AUTHORITY OF SECRETARY.—As a condition; 9 of making a grant under section 1921 to a State for a
p.001321: fiscal year, the Secretary may require that the State modify any provision of the plan submitted by the State
p.001321: under sub- section (a)(6) (including provisions on priorities in carrying out authorized activities). If the
p.001321: Secretary approves the plan and makes the grant to the State for the fiscal year, the Secretary may not
p.001321: during such year require the State to modify the plan.
p.001321: (B) STATE REQUEST FOR MODIFICATION.—If the State determines that a modification to such plan is
p.001321: necessary, the State may request the Secretary to approve the modi- fication. Any such modification shall be
p.001321: in accordance with paragraph (1) and section 1941.
p.001321:
p.001321:
p.001321:
p.001321:
p.001321: January 30, 2020
p.001321: 9 The semicolon after ‘‘a condition’’ in paragraph (2)(A) probably should not appear. See amendment made by
p.001321: section 8002(i)(2)(B)(ii) of Public Law 114–255.
p.001321: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001321:
p.001321:
p.001321:
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p.001321:
p.001321:
p.001323: 1323
p.001323: PUBLIC HEALTH SERVICE ACT
p.001323: Sec. 1933
p.001323:
p.001323: (3) AUTHORITY OF CENTER FOR SUBSTANCE ABUSE PREVEN- TION.—With respect to plans submitted by the States
p.001323: under subsection (a)(6), including any modification under paragraph (2), the Secretary, acting through the
p.001323: Director of the Center for Substance Abuse Prevention, shall review and approve or dis- approve the
p.001323: provisions of the plans that relate to prevention activities.
p.001323: (c) WAIVERS REGARDING CERTAIN TERRITORIES.—In the case of any territory of the United States except Puerto Rico, the
p.001323: Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be
p.001323: appropriate, other than the provisions of section 1931.
p.001323: (d) ISSUANCE OF REGULATIONS; PRECONDITION TO MAKING GRANTS.—
p.001323: (1) REGULATIONS.—Not later than August 25, 1992, the Secretary, acting as appropriate through the Director
p.001323: of the Center for Treatment Improvement or the Director of the Cen- ter for Substance Abuse Prevention, shall by
p.001323: regulation estab- lish standards specifying the circumstances in which the Sec- retary will consider an
p.001323: application for a grant under section 1921 to be in accordance with this section.
p.001323: (2) ISSUANCE AS PRECONDITION TO MAKING GRANTS.—The Secretary may not make payments under any grant under
p.001323: sec- tion 1921 for fiscal year 1993 on or after January 1, 1993, un- less the Secretary has issued standards
p.001323: under paragraph (1).
p.001323: (e) WAIVER AUTHORITY FOR CERTAIN REQUIREMENTS.—
p.001323: (1) IN GENERAL.—Upon the request of a State, the Sec- retary may waive the requirements of all or part
p.001323: of the sec- tions described in paragraph (2) using objective criteria estab- lished by the Secretary by
p.001323: regulation after consultation with the States and other interested parties including consumers and providers.
p.001323: (2) SECTIONS.—The sections described in paragraph (1) are sections 1922(b) 10, 1923, 1924 and 1928.
p.001323: (3) DATE CERTAIN FOR ACTING UPON REQUEST.—The Sec- retary shall approve or deny a request for a waiver
p.001323: under para- graph (1) and inform the State of that decision not later than 120 days after the date on which
p.001323: the request and all the infor- mation needed to support the request are submitted.
p.001323: (4) ANNUAL REPORTING REQUIREMENT.—The Secretary shall annually report to the general public on the
p.001323: States that receive a waiver under this subsection.
p.001323: SEC. 1933. ø300x–33¿ DETERMINATION OF AMOUNT OF ALLOTMENT.
p.001323: (a) STATES.—
p.001323: (1) IN GENERAL.—Subject to subsection (b), the Secretary shall determine the amount of the allotment
p.001323: required in sec- tion 1921 for a State for a fiscal year as follows:
p.001323: (A) The formula established in paragraph (1) of section 1918(a) shall apply to this subsection to the same
p.001323: extent
p.001323:
p.001323:
p.001323:
p.001323:
p.001323:
p.001323: January 30, 2020
p.001323: 10 Section 8002(i)(3) of Public Law 114–255 provides for an amendment to subsection (e)(2) by striking ‘‘section
p.001323: 1922(c)’’ and inserting ‘‘section 1922(b)’’. Such amendment was carried out above by striking ‘‘section[s]
...

p.001329: States under section 1911 or 1921 in order to evaluate compliance with the agreements re- quired under
p.001329: the program involved.
p.001329: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001329:
p.001329:
p.001329:
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p.001329:
p.001329:
p.001331: 1331
p.001331: PUBLIC HEALTH SERVICE ACT
p.001331: Sec. 1947
p.001331:
p.001331:
p.001331:
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p.001331: January 30, 2020
p.001331: (2) PROVISION OF RECORDS ETC. UPON REQUEST.—Each State receiving a grant under section 1911 or
p.001331: 1921, and each entity receiving funds from the grant, shall make appropriate books, documents, papers, and
p.001331: records available to the Sec- retary or the Comptroller General, or any of their duly author- ized
p.001331: representatives, for examination, copying, or mechanical reproduction on or off the premises of the
p.001331: appropriate entity upon a reasonable request therefor.
p.001331: (3) LIMITATIONS ON AUTHORITY.—The Secretary may not institute proceedings under subsection (c) unless the
p.001331: Secretary has conducted an investigation concerning whether the State has expended payments under the program
p.001331: involved in accord- ance with the agreements required under the program. Any such investigation shall be
p.001331: conducted within the State by qualified investigators.
p.001331: SEC. 1946. ø300x–56¿ PROHIBITIONS REGARDING RECEIPT OF FUNDS.
p.001331: (a) ESTABLISHMENT.—
p.001331: (1) CERTAIN FALSE STATEMENTS AND REPRESENTATIONS.—A person shall not knowingly and willfully make or cause
p.001331: to be made any false statement or representation of a material fact in connection with the furnishing of
p.001331: items or services for which payments may be made by a State from a grant made to the State under section
p.001331: 1911 or 1921.
p.001331: (2) CONCEALING OR FAILING TO DISCLOSE CERTAIN EVENTS.—A person with knowledge of the
p.001331: occurrence of any event affecting the initial or continued right of the person to receive any payments from
p.001331: a grant made to a State under sec- tion 1911 or 1921 shall not conceal or fail to disclose any such event with an
p.001331: intent fraudulently to secure such payment ei- ther in a greater amount than is due or when no such amount is
p.001331: due.
p.001331: (b) CRIMINAL PENALTY FOR VIOLATION OF PROHIBITION.—Any person who violates any prohibition established
p.001331: in subsection (a) shall for each violation be fined in accordance with title 18, United States Code, or imprisoned
p.001331: for not more than 5 years, or both.
p.001331: SEC. 1947. ø300x–57¿ NONDISCRIMINATION.
p.001331: (a) IN GENERAL.—
...

p.001331: entity that has received a payment pursuant to section 1911 or 1921, has failed to comply with a provision of
p.001331: law referred to in sub- section (a)(1), with subsection (a)(2), or with an applicable reg- ulation (including one
p.001331: prescribed to carry out subsection (a)(2)), the Secretary shall notify the chief executive officer of the
p.001331: State and shall request the chief executive officer to secure compliance. If within a reasonable period of
p.001331: time, not to exceed
p.001331: 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may—
p.001331: (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be
p.001331: insti- tuted;
p.001331: (B) exercise the powers and functions provided by the Age Discrimination Act of 1975, section 504 of the Reha-
p.001331: bilitation Act of 1973, title IX of the Education Amend- ments of 1972, or title VI of the Civil
p.001331: Rights Act of 1964, as may be applicable; or
p.001331: (C) take such other actions as may be authorized by
p.001331:
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p.001331:
p.001331: January 30, 2020
p.001331: law.
p.001331: (2) AUTHORITY OF ATTORNEY GENERAL.—When a matter is referred to the Attorney General pursuant to paragraph
p.001331: (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a
p.001331: pattern or practice in viola- tion of a provision of law referred to in subsection (a)(1) or in violation
p.001331: of subsection (a)(2), the Attorney General may bring a civil action in any appropriate district court of
p.001331: the United States for such relief as may be appropriate, including injunc- tive relief.
p.001331: SEC. 1948. ø300x–58¿ TECHNICAL ASSISTANCE AND PROVISION OF SUP- PLIES AND SERVICES IN LIEU OF GRANT FUNDS.
p.001331: (a) TECHNICAL ASSISTANCE.—The Secretary shall, without charge to a State receiving a grant under section 1911
p.001331: or 1921, pro- vide to the State (or to any public or nonprofit private entity within the State) technical assistance
p.001331: with respect to the planning, devel- opment, and operation of any program or service carried out pursu- ant to the
p.001331: program involved. The Secretary may provide such tech- nical assistance directly, through contract, or through grants.
p.001331: (b) PROVISION OF SUPPLIES AND SERVICES IN LIEU OF GRANT FUNDS.—
p.001331: (1) IN GENERAL.—Upon the request of a State receiving a grant under section 1911 or 1921, the Secretary
p.001331: may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the State in
p.001331: carrying out the program in- volved and, for such purpose, may detail to the State any offi- cer or employee of the
p.001331: Department of Health and Human Serv- ices.
p.001331: (2) CORRESPONDING REDUCTION IN PAYMENTS.—With re- spect to a request described in paragraph (1), the
p.001331: Secretary shall reduce the amount of payments under the program in-
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p.001333: (3) the definitions for the data elements to be used under the plan;
p.001333: (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved;
p.001333: (5) the resources needed to implement the performance partnerships under the plan; and
p.001333: (6) an implementation strategy complete with rec- ommendations for any necessary legislation.
p.001333: (b) SUBMISSION.—Not later than 2 years after the date of the enactment of this Act 16, the plans
p.001333: developed under subsection (a) shall be submitted to the Committee on Health, Education, Labor, and Pensions of the
p.001333: Senate and the Committee on Commerce of the House of Representatives.
p.001333: (c) INFORMATION.—As the elements of the plans described in subsection (a) are developed, States are
p.001333: encouraged to provide in- formation to the Secretary on a voluntary basis.
p.001333: (d) PARTICIPANTS.—The Secretary shall include among those interested groups that participate in the
p.001333: development of the plan consumers of mental health or substance abuse services, providers, representatives of
p.001333: political divisions of States, and representatives of racial and ethnic groups including Native Americans.
p.001333: SEC. 1950. ø300x–60¿ RULE OF CONSTRUCTION REGARDING DELEGA- TION OF AUTHORITY TO STATES.
p.001333: With respect to States receiving grants under section 1911 or 1921, this part may not be construed to
p.001333: authorize the Secretary to
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333:
p.001333: January 30, 2020
p.001333: 15 Section 1949 appears according to the probable intent of the Congress. Section 3403(a) of Public Law
p.001333: 106–310 (114 Stat. 1219) provides that the section ‘‘is amended as follows:’’. No amendatory instructions
p.001333: were then given, but a substitute text was provided. The amendment probably should have instructed that
p.001333: section 1949 ‘‘is amended to read as follows:’’.
p.001333: 16 The probable intent of the Congress was that the reference to ‘‘this Act’’ be a reference to the
p.001333: Children’s Health Act of 2000 (Public Law 106–310), which provided a substitute text for section 1949 (see
p.001333: footnote 1), including subsection (b) above. That Act was enacted October 17, 2000. (A reference to ‘‘this Act’’
p.001333: is a reference to the Public Health Service Act, which was en- acted July 1, 1944.)
p.001333: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001333:
p.001333:
p.001333:
p.001333:
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p.001333:
p.001333: Sec. 1951 PUBLIC HEALTH SERVICE ACT 1334
p.001333:
p.001333: delegate to the States the primary responsibility for interpreting the governing provisions of this part.
...

p.001337: injunctive re- lief exclusively in an appropriate Federal or State court against the entity, agency or official that
p.001337: allegedly commits such violation.
p.001337: (i) LIMITATIONS ON USE OF FUNDS FOR CERTAIN PURPOSES.—No funds provided through a grant or contract to a
p.001337: religious organiza- tion to provide services under any substance abuse program under this title or title V shall be
p.001337: expended for sectarian worship, instruc- tion, or proselytization.
p.001337: (j) EFFECT ON STATE AND LOCAL FUNDS.—If a State or local government contributes State or local funds to
p.001337: carry out any sub- stance abuse program under this title or title V, the State or local government may segregate
p.001337: the State or local funds from the Fed- eral funds provided to carry out the program or may commingle the State
p.001337: or local funds with the Federal funds. If the State or local government commingles the State or local
p.001337: funds, the provisions of this section shall apply to the commingled funds in the same man- ner, and to the same
p.001337: extent, as the provisions apply to the Federal funds.
p.001337: (k) TREATMENT OF INTERMEDIATE CONTRACTORS.—If a non- governmental organization (referred to in this subsection
p.001337: as an ‘‘in- termediate organization’’), acting under a contract or other agree- ment with the Federal
p.001337: Government or a State or local government, is given the authority under the contract or agreement to select
p.001337: nongovernmental organizations to provide services under any sub- stance abuse program under this title or
p.001337: title V, the intermediate organization shall have the same duties under this section as the government
p.001337: but shall retain all other rights of a nongovernmental organization under this section.
p.001337: SEC. 1956. ø300x–66¿ SERVICES FOR INDIVIDUALS WITH CO-OCCUR- RING DISORDERS.
p.001337: States may use funds available for treatment under sections 1911 and 1921 to treat persons with
p.001337: co-occurring substance abuse and mental disorders as long as funds available under such sec- tions are
p.001337: used for the purposes for which they were authorized by law and can be tracked for accounting purposes.
p.001337: SEC. 1957. ø300x-67¿ PUBLIC HEALTH EMERGENCIES.
p.001337: In the case of a public health emergency (as determined under section 319), the Secretary, on a State by State basis,
p.001337: may, as the circumstances of the emergency reasonably require and for the pe-
p.001337: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001337:
p.001337:
p.001337:
p.001337:
p.001337:
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p.001337:
...

p.001343: regulations promulgated by the Secretary;
p.001343: (5) ‘‘core services’’ means those services which shall be pro- vided by a grantee, as determined by the Secretary by
p.001343: regula- tion;
p.001343: (6) ‘‘supplemental services’’ means those services which may be provided by a grantee, as determined by the
p.001343: Secretary by regulation;
p.001343: (7) ‘‘care services’’ means necessary services for the provi- sion of care to pregnant adolescents and
p.001343: adolescent parents and includes all core services with respect to the provision of such care prescribed by
p.001343: the Secretary by regulation;
p.001343: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001343:
p.001343:
p.001343:
p.001343:
p.001343:
p.001343:
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p.001343:
p.001343:
p.001345: 1345
p.001345: PUBLIC HEALTH SERVICE ACT
p.001345: Sec. 2004
p.001345:
p.001345: (8) ‘‘prevention services’’ means necessary services to pre- vent adolescent sexual relations, including
p.001345: the services de- scribed in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4);
p.001345: (9) ‘‘adolescent’’ means an individual under the age of nine- teen; and
p.001345: (10) ‘‘unemancipated minor’’ means a minor who is subject to the control, authority, and supervision of his or her
p.001345: parents or guardians, as determined under State law.
p.001345: (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this
p.001345: subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers
p.001345: Amendments of 1978 which were in effect on the date of enactment of this title, to determine which necessary
p.001345: services are core services for purposes of this title. The Secretary may promulgate regulations to determine
p.001345: which necessary services are core services for purposes of this title based upon an evaluation of and information
p.001345: concerning which necessary services are essen- tial to carry out the purposes of this title and taking
p.001345: into account
p.001345: (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served,
p.001345: and the nature of the populations to be served, and (2) the results of the evaluations re- quired under section
p.001345: 2006(b). The Secretary may from time to time revise such regulations.
p.001345: AUTHORITY TO MAKE GRANTS FOR DEMONSTRATION PROJECTS
p.001345: SEC. 2003. ø300z–2¿ (a) The Secretary may make grants to fur- ther the purposes of this title to eligible grant
p.001345: recipients which have submitted an application which the Secretary finds meets the requirements of section 2006
p.001345: for demonstration projects which the Secretary determines will help communities provide appropriate care and
p.001345: prevention services in easily accessible locations. Dem- onstration projects shall, as appropriate,
p.001345: provide, supplement, or improve the quality of such services. Demonstration projects shall use such methods
p.001345: as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of
p.001345: adolescents and to make use of support systems such as other family members, friends, religious and charitable
p.001345: organizations, and voluntary asso- ciations.
p.001345: (b) Grants under this title for demonstration projects may be for the provision of—
p.001345: (1) care services;
p.001345: (2) prevention services; or
p.001345: (3) a combination of care services and prevention services.
p.001345:
p.001345:
p.001345:
p.001345:
p.001345:
p.001345:
p.001345:
p.001345:
p.001345:
p.001345: January 30, 2020
p.001345:
p.001345: USES OF GRANTS FOR DEMONSTRATION PROJECTS FOR SERVICES
p.001345: SEC. 2004. ø300z–3¿ (a) Except as provided in subsection (b), funds provided for demonstration projects
p.001345: for services under this title may be used by grantees only to—
p.001345: (1) provide to eligible persons—
p.001345: (A) care services;
p.001345: (B) prevention services; or
...

p.001379: intermittently.
p.001379: (e) STAFF.—The Secretary shall provide the Commission with such professional and clerical staff, such
p.001379: information, and the serv- ices of such consultants as may be necessary to assist the Commis- sion in carrying out
p.001379: effectively its functions under this section.
p.001379: (f) FUNCTIONS.—The Commission shall—
p.001379: (1) advise the Secretary on the implementation of the Pro- gram,
p.001379: (2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine
p.001379: Injury Table,
p.001379: (3) advise the Secretary in implementing the Secretary’s responsibilities under section 2127 regarding
p.001379: the need for childhood vaccination products that result in fewer or no sig- nificant adverse reactions,
p.001379: (4) survey Federal, State, and local programs and activities relating to the gathering of information on
p.001379: injuries associated with the administration of childhood vaccines, including the adverse reaction reporting
p.001379: requirements of section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data
p.001379: related to the frequency and severity of ad- verse reactions associated with childhood vaccines, and
p.001379: (5) recommend to the Director of the National Vaccine Pro- gram research related to vaccine injuries which should be
p.001379: con- ducted to carry out this subtitle.
p.001379: PART B—ADDITIONAL REMEDIES
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
p.001379: January 30, 2020
p.001379:
p.001379: AUTHORITY TO BRING ACTIONS
p.001379: SEC. 2121. ø300aa–21¿ (a) ELECTION.—After judgment has been entered by the United States Claims Court
p.001379: or, if an appeal is taken under section 2112(f), after the appellate court’s mandate is issued, the
p.001379: petitioner who filed the petition under section 2111 shall file with the clerk of the United States Claims
p.001379: Court—
p.001379: (1) if the judgment awarded compensation, an election in writing to receive the compensation or to file a civil
p.001379: action for damages for such injury or death, or
p.001379: (2) if the judgment did not award compensation, an elec- tion in writing to accept the judgment or to
p.001379: file a civil action for damages for such injury or death.
p.001379: An election shall be filed under this subsection not later than 90 days after the date of the court’s
p.001379: final judgment with respect to which the election is to be made. If a person required to file an
p.001379: election with the court under this subsection does not file the elec- tion within the time prescribed for filing
p.001379: the election, such person shall be deemed to have filed an election to accept the judgment of the
p.001379: court. If a person elects to receive compensation under a
p.001379: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001379:
p.001379:
p.001379:
p.001379:
p.001379:
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p.001379:
p.001379: Sec. 2122 PUBLIC HEALTH SERVICE ACT 1380
p.001379:
...

p.001385: occurrence.
p.001385: PART D—GENERAL PROVISIONS
p.001385: CITIZEN’S ACTIONS
p.001385: SEC. 2131. ø300aa–31¿ (a) GENERAL RULE.—Except as pro-
p.001385: vided in subsection (b), any person may commence in a district court of the United States a civil
p.001385: action on such person’s own be- half against the Secretary where there is alleged a failure of the
p.001385: Secretary to perform any act or duty under this subtitle.
p.001385: (b) NOTICE.—No action may be commenced under subsection
p.001385: (a) before the date which is 60 days after the person bringing the action has given written notice of
p.001385: intent to commence such action to the Secretary.
p.001385: (c) COSTS OF LITIGATION.—The court, in issuing any final order in any action under this section, may award costs of
p.001385: litigation (in- cluding reasonable attorney and expert witness fees) to any plain- tiff who substantially
p.001385: prevails on one or more significant issues in the action.
p.001385: JUDICIAL REVIEW
p.001385: SEC. 2132. ø300aa–32¿ A petition for review of a regulation under this subtitle may be filed in a court of
p.001385: appeals of the United States within 60 days from the date of the promulgation of the reg- ulation or after such
p.001385: date if such petition is based solely on grounds arising after such 60th day.
p.001385: DEFINITIONS
p.001385: SEC. 2133. 28 ø300aa–33¿ For purposes of this subtitle:
p.001385: (1) The term ‘‘health care provider’’ means any licensed health care professional, organization, or
p.001385: institution, whether public or private (including Federal, State, and local depart- ments, agencies, and
p.001385: instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered.
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385:
p.001385: January 30, 2020
p.001385: 28 Paragraphs (3) and (5) above appear so as to reflect the probable intent of the Congress, and former
p.001385: paragraph (7) has been struck to reflect such intent. Sections 1714, 1715, and 1716 of Public Law 107–296 (116
p.001385: Stat. 2320, 2321) made amendments to section 2133 with respect to such paragraphs. Subsequently, section
p.001385: 102(a) of division L of Public Law 108–7 (117 Stat.
p.001385: 528) was enacted, and that section indicated the intent of the Congress to nullify those amend- ments. That section
p.001385: repealed sections 1714, 1715, and 1716 rather than directly amending para- graphs (3), (5), and (7). (That
p.001385: section also repealed section 1717, which related to effective dates.)
p.001385: Section 102(b) of Public Law 108–7 provided as follows: ‘‘The Public Health Service Act (42
p.001385: U.S.C. 201 et seq.) shall be applied and administered as if the sections repealed by subsection
p.001385: (a) had never been enacted.’’. Consistent with that provision, section 2133 is shown above to re- flect the
p.001385: assumption that repealing a provision of law that makes a change in an Act has the effect of amending
p.001385: that Act so as to undo the change.
p.001385: Section 102(c) of such Public Law provides as follows: ‘‘No inference shall be drawn from the enactment of sections
p.001385: 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107- 296), or from this repeal, regarding the
...

p.001397: conditions; and
p.001397: (ii) are being utilized for such purpose by individ- uals infected with such etiologic agent;
p.001397: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001397:
p.001397:
p.001397:
p.001397:
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p.001397:
p.001397: Sec. 2311 PUBLIC HEALTH SERVICE ACT 1398
p.001397:
p.001397: (2)(A) review ongoing publicly and privately supported re- search on clinical treatment for acquired
p.001397: immune deficiency syndrome, including research on drugs described in paragraph (1); and
p.001397: (B) periodically issue, and make available to health care professionals, reports describing and evaluating such
p.001397: research;
p.001397: (3) conduct studies and convene meetings for the purpose of determining the recommendations among physicians in
p.001397: clin- ical practice on clinical treatment of acquired immune defi- ciency syndrome, including treatment with
p.001397: the drugs described in paragraph (1); and
p.001397: (4) conduct a study for the purpose of developing, with re- spect to individuals infected with the etiologic
p.001397: agent for ac- quired immune deficiency syndrome, a consensus among health care professionals on clinical
p.001397: treatments for preventing or minimizing the development of symptoms or conditions arising from infection with
p.001397: such etiologic agent.
p.001397: PART B—RESEARCH AUTHORITY
p.001397: SEC. 2311. ø300cc–11¿ CLINICAL EVALUATION UNITS AT NATIONAL IN- STITUTES OF HEALTH.
p.001397: (a) IN GENERAL.—The Secretary, acting through the Director of the National Cancer Institute and the Director of the
p.001397: National In- stitute of Allergy and Infectious Diseases, shall for each such Insti- tute establish a clinical
p.001397: evaluation unit at the Clinical Center at the National Institutes of Health. Each of the clinical
p.001397: evaluation units—
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397:
p.001397: January 30, 2020
p.001397: (1) shall conduct clinical evaluations of experimental treat- ments for acquired immune deficiency syndrome
p.001397: developed within the preclinical drug development program, including evaluations of methods of diagnosing
p.001397: immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic
p.001397: cancers and infectious diseases; and
p.001397: (2) may conduct clinical evaluations of experimental treat- ments for such syndrome that are developed by any
p.001397: other na- tional research institute of the National Institutes of Health or by any other entity.
p.001397: (b) PERSONNEL AND ADMINISTRATIVE SUPPORT.—
p.001397: (1) For the purposes described in subsection (a), the Sec- retary, acting through the Director of the
p.001397: National Institutes of Health, shall provide each of the clinical evaluation units re- quired in such subsection—
p.001397: (A)(i) with not less than 50 beds; or
...

p.001401: (2) with respect to carrying out the purpose for which the assistance is to be made, the application
p.001401: provides assurances of compliance satisfactory to the Secretary; and
p.001401: (3) the application otherwise is in such form, is made in such manner, and contains such agreements,
p.001401: assurances, and information as the Secretary determines to be necessary to carry out this section.
p.001401: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.001401: (1) For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated such sums as may
p.001401: be nec- essary for each of the fiscal years 1989 through 1996.
p.001401: (2) For the purpose of carrying out subsection (b)(2), there are authorized to be appropriated such sums as may
p.001401: be nec- essary for each of the fiscal years 1989 through 1996.
p.001401: SEC. 2314. ø300cc–14¿ EVALUATION OF CERTAIN TREATMENTS.
p.001401: (a) ESTABLISHMENT OF PROGRAM.—
p.001401: (1) After consultation with the AIDS Research Advisory Committee established pursuant to section 2304, the
p.001401: Secretary shall establish a program for the evaluation of drugs that—
p.001401: (A) are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to ac-
p.001401: quired immune deficiency syndrome; and
p.001401: (B) are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome.
p.001401: (2) The program established under paragraph (1) shall in- clude evaluations of the effectiveness and the risks of the
p.001401: treat- ment involved, including the risks of foregoing treatments with respect to acquired immune deficiency
p.001401: syndrome that are ap- proved by the Commissioner of Food and Drugs.
p.001401: (b) AUTHORITY WITH RESPECT TO GRANTS AND CONTRACTS.—
p.001401: (1) For the purpose of conducting evaluations required in subsection (a), the Secretary may make grants
p.001401: to, and enter
p.001401: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001401:
p.001401:
p.001401:
p.001401:
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p.001401:
p.001401: Sec. 2315 PUBLIC HEALTH SERVICE ACT 1402
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401:
p.001401: January 30, 2020
p.001401:
p.001401: into cooperative agreements and contracts with, public and nonprofit private entities.
p.001401: (2) Nonprofit private entities under paragraph (1) may in- clude nonprofit private organizations that—
p.001401: (A) are established for the purpose of evaluating treat- ments with respect to acquired immune deficiency syn-
p.001401: drome; and
p.001401: (B) consist primarily of individuals infected with the etiologic agent for such syndrome.
p.001401: (c) SCIENTIFIC AND ETHICAL GUIDELINES.—
...

p.001407: Education programs shall be directed at health professionals, patients, and the commu- nity to—
p.001407: (1) in the case of the public and patients undergoing treat- ment—
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
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p.001407:
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p.001407:
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p.001407:
p.001407:
p.001407:
p.001407:
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p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407:
p.001407: January 30, 2020
p.001407: (A) increase awareness that the process of donating blood is safe;
p.001407: (B) promote the concept that blood donors are contrib- utors to a national need to maintain an adequate and safe blood
p.001407: supply;
p.001407: (C) encourage blood donors to donate more than once a year; and
p.001407: (D) encourage repeat blood donors to recruit new do- nors;
p.001407: (2) in the case of health professionals—
p.001407: (A) improve knowledge, attitudes, and skills of health professionals in the appropriate use of blood and
p.001407: blood components;
p.001407: (B) increase the awareness and understanding of health professionals regarding the risks versus
p.001407: benefits of blood transfusion; and
p.001407: (C) encourage health professionals to consider alter- natives to the administration of blood or blood components
p.001407: for their patients; and
p.001407: (3) in the case of the community, increase coordination, communication, and collaboration among community,
p.001407: profes- sional, industry, and government organizations regarding blood donation and transfusion issues.
p.001407: SEC. 2320. ø300cc–20¿ ADDITIONAL AUTHORITY WITH RESPECT TO RE- SEARCH.
p.001407: (a) DATA COLLECTION WITH RESPECT TO NATIONAL PREVA-
p.001407: LENCE.—
p.001407: (1) The Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention, may, through
p.001407: rep- resentative sampling and other appropriate methodologies, pro-
p.001407: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001407:
p.001407:
p.001407:
p.001407:
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p.001407:
p.001407: Sec. 2320 PUBLIC HEALTH SERVICE ACT 1408
p.001407:
p.001407: vide for the continuous collection of data on the incidence in the United States of cases of acquired immune
p.001407: deficiency syn- drome and of cases of infection with the etiologic agent for such syndrome. The Secretary may carry
p.001407: out the program of data collection directly or through cooperative agreements and con- tracts with public
p.001407: and nonprofit private entities.
p.001407: (2) The Secretary shall encourage each State to enter into a cooperative agreement or contract under paragraph
p.001407: (1) with the Secretary in order to facilitate the prompt collection of the most recent accurate data on the
p.001407: incidence of cases described in such paragraph.
p.001407: (3) The Secretary shall ensure that data collected under paragraph (1) includes data on the demographic
p.001407: characteristics of the population of individuals with cases described in para- graph (1), including data
...

p.001417: estab- lished by health care professionals for providing such services to such individuals;
p.001417: (2) provide for the identification, location, and provision of outreach to eligible individuals;
p.001417: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001417:
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p.001419: 1419
p.001419: PUBLIC HEALTH SERVICE ACT
p.001419: Sec. 2404
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p.001419: January 30, 2020
p.001419: (3) provide for coordinating the provision of services under this part with the provision of similar or related
p.001419: services by public and private entities; and
p.001419: (4) give priority to the provision of outreach and home and community-based services to eligible individuals with
p.001419: low in- comes.
p.001419: (b) AUTHORITY FOR GRANTS AND CONTRACTS.—A State may make payment for services under subsection (a)
p.001419: through grants to public and nonprofit private entities and through contracts with public and private
p.001419: entities. In providing such financial assistance, a State shall give priority to public and nonprofit
p.001419: private entities that have demonstrated experience in delivering home and commu- nity-based health services to
p.001419: individuals infected with the etiologic agent for acquired immune deficiency syndrome.
p.001419: SEC. 2403. ø300dd–2¿ REQUIREMENT OF SUBMISSION OF DESCRIPTION OF INTENDED USES OF GRANT.
p.001419: The Secretary may not make payments under section 2401(a) to a State for a fiscal year unless—
p.001419: (1) the State submits to the Secretary a description of the purposes for which the State intends to expend such
p.001419: payments for the fiscal year;
p.001419: (2) such description provides information relating to the services and activities to be provided,
p.001419: including a description of the manner in which such services and activities will be co- ordinated with any similar
p.001419: services and activities of public and private entities; and
p.001419: (3) such description includes information relating to (A) the process for determining which eligible
p.001419: individuals are medically dependent or chronically dependent and (B) the proc- ess for establishing written plans
p.001419: of care for the provision of home and community-based health services under this part.
p.001419: SEC. 2404. ø300dd–3¿ RESTRICTIONS ON USE OF GRANT.
...

p.001439: The Secretary shall annually prepare a report on the activities of the States carried out pursuant to this part. Such
p.001439: report may in- clude any recommendations of the Secretary for appropriate admin- istrative and legislative
p.001439: initiatives. The report shall be submitted to the Congress through inclusion in the comprehensive report
p.001439: re- quired in section 2301(a).
p.001439: SEC. 2513. ø300ee–23¿ DEFINITION.
p.001439: For purposes of this part, the term ‘‘infection with the etiologic agent for acquired immune deficiency syndrome’’
p.001439: includes any con- dition arising from such etiologic agent.
p.001439: SEC. 2514. ø300ee–24¿ FUNDING.
p.001439: (a) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of making allotments under section 2501(a), there
p.001439: are authorized to be appropriated $165,000,000 for fiscal year 1989 and such sums as may be necessary for
p.001439: each of the fiscal years 1990 and 1991.
p.001439: (b) AVAILABILITY TO STATES.—Any amounts paid to a State under section 2501(a) shall remain available to the
p.001439: State until the expiration of the 1-year period beginning on the date on which the State receives such amounts.
p.001439: PART B—NATIONAL INFORMATION PROGRAMS
p.001439: SEC. 2521. ø300ee–31¿ AVAILABILITY OF INFORMATION TO GENERAL PUBLIC.
p.001439: (a) COMPREHENSIVE INFORMATION PLAN.—The Secretary, act- ing through the Director of the Centers for
p.001439: Disease Control and Prevention, shall annually prepare a comprehensive plan, including a budget, for a National
p.001439: Acquired Immune Deficiency Syndrome In- formation Program. The plan shall contain provisions to implement the
p.001439: provisions of this title. The Director shall submit such plan to the Secretary. The authority established in
p.001439: this subsection may not be construed to be the exclusive authority for the Director to carry out information
p.001439: activities with respect to acquired immune defi- ciency syndrome.
p.001439: (b) CLEARINGHOUSE.—
p.001439: (1) The Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention, may establish a
p.001439: clear- inghouse to make information concerning acquired immune de- ficiency syndrome available to Federal agencies,
p.001439: States, public and private entities, and the general public.
p.001439: (2) The clearinghouse may conduct or support programs—
p.001439: (A) to develop and obtain educational materials, model curricula, and methods directed toward reducing the trans-
p.001439: mission of the etiologic agent for acquired immune defi- ciency syndrome;
p.001439: (B) to provide instruction and support for individuals who provide instruction in methods and techniques of edu-
p.001439: cation relating to the prevention of acquired immune defi-
p.001439: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001439:
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p.001441: 1441
p.001441: PUBLIC HEALTH SERVICE ACT
p.001441: Sec. 2523
p.001441:
p.001441: ciency syndrome and instruction in the use of the mate- rials and curricula described in subparagraph (A); and
p.001441: (C) to conduct, or to provide for the conduct of, the ma- terials, curricula, and methods described in paragraph
p.001441: (1) and the efficacy of such materials, curricula, and methods in preventing infection with the the 4 etiologic agent
p.001441: for ac- quired immune deficiency syndrome.
...

p.001457: such balance that is the subject of a waiver of cancellation under subparagraph (A)), the amount of the
p.001457: grant under such subsection for the first fiscal year beginning after the fiscal year in which the Secretary
p.001457: obtains the information necessary for determining that such balance was unobligated as of the end of the grant
p.001457: year (which requirement for a reduction applies without re-
p.001457: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001457: Sec. 2603 PUBLIC HEALTH SERVICE ACT 1458
p.001457: gard to whether a waiver under subparagraph (A) has been approved with respect to such balance); and
p.001457: (II) the grant funds involved in such reduction shall be made available by the Secretary as addi- tional funds
p.001457: for grants pursuant to subsection (b) for such first fiscal year, subject to subsection (a)(4) and section
p.001457: 2610(d)(2);
p.001457: except that this clause does not apply to the eligible area if the amount of the unobligated balance
p.001457: was 5 percent or less.
p.001457: (ii) RELATION TO INCREASES IN GRANT.—A reduc- tion under clause (i) for an eligible area for a fiscal
p.001457: year may not be taken into account in applying sub- section (a)(4) with respect to the area for the
p.001457: subse- quent fiscal year.
p.001457: (4) AUTHORITY REGARDING ADMINISTRATION OF PROVI- SIONS.—In administering paragraphs (2) and (3)
p.001457: with respect to the unobligated balance of an eligible area, the Secretary may elect to reduce the
p.001457: amount of future grants to the area under subsection (a) or (b), as applicable, by the amount of any such
p.001457: unobligated balance in lieu of cancelling such amount as provided for in paragraph (2) or (3)(A). In
p.001457: such case, the Sec- retary may permit the area to use such unobligated balance for purposes of any such future
p.001457: grant. An amount equal to such reduction shall be available for use as additional amounts for grants
p.001457: pursuant to subsection (b), subject to subsection (a)(4) and section 2610(d)(2). Nothing in this paragraph shall
p.001457: be con- strued to affect the authority of the Secretary under para- graphs (2) and (3), including the
p.001457: authority to grant waivers under paragraph (3)(A). The reduction in future grants author- ized under this
p.001457: paragraph shall be notwithstanding the pen- alty required under paragraph (3)(D) with respect to unobli-
p.001457: gated funds.
p.001457: (d) COMPLIANCE WITH PRIORITIES OF HIV PLANNING COUN-
p.001457: CIL.—Notwithstanding any other provision of this subpart, the Sec- retary, in carrying out section 2601(a), may
p.001457: not make any grant under subsection (a) or (b) to an eligible area unless the application submitted by such area
p.001457: under section 2605 for the grant involved demonstrates that the grants made under subsections (a) and
p.001457: (b) to the area for the preceding fiscal year (if any) were expended in accordance with the priorities
p.001457: applicable to such year that were es- tablished, pursuant to section 2602(b)(4)(C), by the planning coun- cil serving
p.001457: the area.
p.001457: (e) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001457: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001457: shall include information detail- ing—
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p.001457: January 30, 2020
p.001457: (1) the total amount of supplemental funds available under this section for the year involved;
p.001457: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of subsection (a)(4);
p.001457: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001471: purposes of section 2603(a)(4).
p.001471: (3) If the amounts referred to in paragraph (1) are not suf- ficient for making all the reductions, the reductions
p.001471: shall be re- duced until the total amount of the reductions equals the total of the amounts referred to in such
p.001471: paragraph.
p.001471: (e) RULES OF CONSTRUCTION REGARDING FIRST SUBSEQUENT FISCAL YEAR.—Paragraphs (1) and (2) of subsection
p.001471: (c) apply with respect to each series of fiscal years during which a metropolitan area is an eligible
p.001471: area under subpart I or a transitional area under section 2609 for a fiscal year and then for a subsequent fis-
p.001471: cal year ceases to be such an area by reason of section 2601(b) or 2609(c)(2), respectively, rather
p.001471: than applying to a single such se- ries. Paragraph (3) of subsection (c) applies with respect to each se- ries
p.001471: of fiscal years during which a metropolitan area is a transi- tional area under section 2609 for a fiscal
p.001471: year and then for a sub- sequent fiscal year becomes an eligible area under subpart I, rather than applying to a single
p.001471: such series.
p.001471: PART B—CARE GRANT PROGRAM 6
p.001471: Subpart I—General Grant Provisions
p.001471: SEC. 2611. ø300ff–21¿ GRANTS.
p.001471: The Secretary shall, subject to the availability of appropria- tions, make grants to States to enable
p.001471: such States to improve the quality, availability and organization of health care and support services for
p.001471: individuals and families with HIV/AIDS. The authority
p.001471:
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p.001471: January 30, 2020
p.001471: 6 See footnote at the beginning of part A.
p.001471: Section 8(a) of Public Law 104–146 (110 Stat. 1372) establishes a condition for the receipt of grants under part B.
p.001471: The condition relates to notification of spouses of HIV-infected patients.
p.001471: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001473: 1473
p.001473: PUBLIC HEALTH SERVICE ACT
p.001473: Sec. 2612
p.001473:
p.001473: of the Secretary to provide grants under part B is subject to section 2626(e)(2) (relating to the decrease in
p.001473: perinatal transmission of HIV/AIDS).
p.001473: SEC. 2612. ø300ff–22¿ GENERAL USE OF GRANTS.
p.001473: (a) IN GENERAL.—A State may use amounts provided under grants made under section 2611 for—
p.001473: (1) core medical services described in subsection (b);
p.001473: (2) support services described in subsection (c); and
p.001473: (3) administrative expenses described in section 2618(b)(3).
p.001473: (b) REQUIRED FUNDING FOR CORE MEDICAL SERVICES.—
p.001473: (1) IN GENERAL.—With respect to a grant under section 2611 for a State for a grant year, the State shall, of
p.001473: the portion of the grant remaining after reserving amounts for purposes of subparagraphs (A) and (E)(ii)(I) of
p.001473: section 2618(b)(3), use not less than 75 percent to provide core medical services that are needed in the
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p.001479: January 30, 2020
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p.001479: out services under paragraph (6), except that the percentage appli- cable with respect to such paragraph is 10
p.001479: percent if the State demonstrates to the Secretary that such additional services are es- sential and in no way
p.001479: diminish access to the therapeutics described in subsection (a).
p.001479: (d) DUTIES OF THE SECRETARY.—In carrying out this section, the Secretary shall review the current
p.001479: status of State drug reim- bursement programs established under section 2612(2) and assess barriers to the
p.001479: expanded availability of the treatments described in subsection (a). The Secretary shall also examine the
p.001479: extent to which States coordinate with other grantees under this title to re- duce barriers to the expanded
p.001479: availability of the treatments de- scribed in subsection (a).
p.001479: (e) LIST OF CLASSES OF CORE ANTIRETROVIRAL THERA- PEUTICS.—For purposes of subsection (c)(1),
p.001479: the Secretary shall de- velop and maintain a list of classes of core antiretroviral thera- peutics, which
p.001479: list shall be based on the therapeutics included in the guidelines of the Secretary known as the
p.001479: Clinical Practice Guidelines for Use of HIV/AIDS Drugs, relating to drugs needed to manage symptoms associated with
p.001479: HIV. The preceding sentence does not affect the authority of the Secretary to modify such Guide- lines.
p.001479: (f) USE OF HEALTH INSURANCE AND PLANS.—
p.001479: (1) IN GENERAL.—In carrying out subsection (a), a State may expend a grant under section 2611 to
p.001479: provide the thera- peutics described in such subsection by paying on behalf of in- dividuals with HIV/AIDS the
p.001479: costs of purchasing or maintain- ing health insurance or plans whose coverage includes a full range of
p.001479: such therapeutics and appropriate primary care serv- ices.
p.001479: (2) LIMITATION.—The authority established in paragraph
p.001479: (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans
p.001479: to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing
p.001479: therapeutics described in subsection (a).
p.001479: (g) DRUG REBATE PROGRAM.—A State shall ensure that any drug rebates received on drugs purchased from funds
p.001479: provided pur- suant to this section are applied to activities supported under this subpart, with priority given to
p.001479: activities described under this sec- tion.
p.001479: SEC. 2617. ø300ff–27¿ STATE APPLICATION.
p.001479: (a) IN GENERAL.—The Secretary shall not make a grant to a State under section 2611 for a fiscal year unless
p.001479: the State prepares and submits, to the Secretary, an application at such time, in such form, and containing such
p.001479: agreements, assurances, and information as the Secretary determines to be necessary to carry out section
p.001479: 2611.
p.001479: (b) DESCRIPTION OF INTENDED USES AND AGREEMENTS.—The application submitted under subsection (a) shall
p.001479: contain—
p.001479: (1) a detailed description of the HIV-related services pro- vided in the State to individuals and
p.001479: families with HIV/AIDS during the year preceding the year for which the grant is re-
p.001479: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001497: consistent with the grant award to the State for fiscal year 2006, to the extent that the factor under
p.001497: subsection (b)(10) (re- lating to a decline in funding) applies to the State.
p.001497: (d) REPORT ON THE AWARDING OF SUPPLEMENTAL FUNDS.—Not later than 45 days after the awarding of supplemental funds
p.001497: under this section, the Secretary shall submit to Congress a report con- cerning such funds. Such report
p.001497: shall include information detail- ing—
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p.001497: (1) the total amount of supplemental funds available under
p.001497: this section for the year involved;
p.001497: (2) the amount of supplemental funds used in accordance with the hold harmless provisions of section
p.001497: 2618(a)(2);
p.001497: (3) the amount of supplemental funds disbursed pursuant to subsection (c);
p.001497: (4) the disbursement of the remainder of the supplemental funds after taking into account the uses described in
p.001497: para- graphs (2) and (3); and
p.001497: (5) the rationale used for the amount of funds disbursed as described under paragraphs (2), (3), and (4).
p.001497: (e) CORE MEDICAL SERVICES.—The provisions of section 2612(b) apply with respect to a grant under this section to the
p.001497: same extent and in the same manner as such provisions apply with respect to a grant made pursuant to section
p.001497: 2618(a)(1).
p.001497: (f) APPLICABILITY OF GRANT AUTHORITY.—The authority to make grants under this section applies beginning
p.001497: with the first fis- cal year for which amounts are made available for such grants under section 2623(b)(1).
p.001497: SEC. 2621. ø300ff–30¿ EMERGING COMMUNITIES.
p.001497: (a) IN GENERAL.—The Secretary shall award supplemental grants to States determined to be eligible
p.001497: under subsection (b) to enable such States to provide comprehensive services of the type described in
p.001497: section 2612(a) to supplement the services otherwise provided by the State under a grant under this
p.001497: subpart in emerg- ing communities within the State that are not eligible to receive grants under part A.
p.001497: (b) ELIGIBILITY.—To be eligible to receive a supplemental grant under subsection (a), a State shall—
p.001497: (1) be eligible to receive a grant under this subpart;
p.001497: (2) demonstrate the existence in the State of an emerging community as defined in subsection (d)(1);
p.001497: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001499: have applied, the State may request that for purposes of this sec- tion, the Secretary deem the State’s
p.001499: unobligated balance to be re- duced by the amount of rebate funds in the proposed expenditure.
p.001499: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001501: 1501
p.001501: PUBLIC HEALTH SERVICE ACT
p.001501: Sec. 2623
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p.001501: January 30, 2020
p.001501: Notwithstanding 2618(a)(2)(F), any unobligated amount under sec- tion 2618(a)(2)(F)(ii)(V) that is returned to
p.001501: the Secretary for re- allocation shall be used by the Secretary for—
p.001501: (1) the ADAP supplemental program if the Secretary de- termines appropriate; or
p.001501: (2) for additional amounts for grants pursuant to section 2620.
p.001501: (e) AUTHORITY REGARDING ADMINISTRATION OF PROVISIONS.— In administering subsections (b) and (c) with respect to
p.001501: the unobli- gated balance of a State, the Secretary may elect to reduce the amount of future grants to
p.001501: the State under section 2618, 2620, or 2621, as applicable, by the amount of any such unobligated balance in
p.001501: lieu of cancelling such amount as provided for in subsection (b) or (c)(1). In such case, the Secretary
p.001501: may permit the State to use such unobligated balance for purposes of any such future grant. An amount equal to
p.001501: such reduction shall be available for use as addi- tional amounts for grants pursuant to section 2620, subject to sec-
p.001501: tion 2618(a)(2)(H). Nothing in this paragraph shall be construed to affect the authority of the Secretary under
p.001501: subsections (b) and (c), including the authority to grant waivers under subsection (c)(1). The reduction
p.001501: in future grants authorized under this subsection shall be notwithstanding the penalty required under
p.001501: subsection (c)(4) with respect to unobligated funds.
p.001501: SEC. 2623. AUTHORIZATION OF APPROPRIATIONS.
p.001501: (a) IN GENERAL.—For the purpose of carrying out this subpart, there are authorized to be appropriated
p.001501: $1,195,500,000 for fiscal year 2007, $1,239,500,000 for fiscal year 2008, $1,285,200,000 for fiscal year
p.001501: 2009, $1,349,460,000 for fiscal year 2010, $1,416,933,000 for fiscal year 2011, $1,487,780,000 for fiscal
p.001501: year 2012, and
p.001501: $1,562,169,000 for fiscal year 2013. Amounts appropriated under the preceding sentence for a fiscal year are
p.001501: available for obligation by the Secretary until the end of the second succeeding fiscal year.
p.001501: (b) RESERVATION OF AMOUNTS.—
p.001501: (1) EMERGING COMMUNITIES.—Of the amount appropriated under subsection (a) for a fiscal year, the Secretary
p.001501: shall re- serve $5,000,000 for grants under section 2621.
p.001501: (2) SUPPLEMENTAL GRANTS.—
p.001501: (A) IN GENERAL.—Of the amount appropriated under subsection (a) for a fiscal year in excess of the 2006
p.001501: ad- justed amount, the Secretary shall reserve 1⁄3 for grants under section 2620, except that the
p.001501: availability of the re- served funds for such grants is subject to section 2618(a)(2)(H) as applied
p.001501: for such year, and except that any amount appropriated exclusively for carrying out section 2616 (and,
p.001501: accordingly, distributed under section 2618(a)(2)(F)) is not subject to this subparagraph.
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p.001521: local government or pri- vate nonprofit entity shall provide assurances to the Secretary that services funded
p.001521: under this title will be integrated with other such services, that programs will be coordinated with
p.001521: other available programs (including Medicaid), and that the continuity of care and prevention services of individuals
p.001521: with HIV is enhanced.
p.001521: SEC. 2682. ø300ff–82¿ AUDITS.
p.001521: (a) IN GENERAL.—For fiscal year 2009, and each subsequent fiscal year, the Secretary may reduce the amounts of
p.001521: grants under this title to a State or political subdivision of a State for a fiscal year if, with
p.001521: respect to such grants for the second preceding fiscal year, the State or subdivision fails to prepare audits
p.001521: in accordance with the procedures of section 7502 of title 31, United States Code. The Secretary shall annually select
p.001521: representative samples of such audits, prepare summaries of the selected audits, and submit the summaries to
p.001521: the Congress.
p.001521: (b) POSTING ON THE INTERNET.—All audits that the Secretary receives from the State lead agency under
p.001521: section 2617(b)(4) shall be posted, in their entirety, on the Internet website of the Health Resources and
p.001521: Services Administration.
p.001521: SEC. 2683. ø300ff–83¿ PUBLIC HEALTH EMERGENCY.
p.001521: (a) IN GENERAL.—In an emergency area and during an emer- gency period, the Secretary shall have the authority
p.001521: to waive such requirements of this title to improve the health and safety of those receiving care under this title
p.001521: and the general public, except that the Secretary may not expend more than 5 percent of the funds al- located
p.001521: under this title for sections 2620 and section 2603(b).
p.001521: (b) EMERGENCY AREA AND EMERGENCY PERIOD.—In this sec- tion:
p.001521: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001521: January 30, 2020
p.001521:
p.001521: (1) EMERGENCY AREA.—The term ‘‘emergency area’’ means a geographic area in which there exists—
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p.001537:
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p.001539: 1539
p.001539: PUBLIC HEALTH SERVICE ACT
p.001539: Sec. 2703
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p.001539: (ii) it is applying this paragraph uniformly to all employers and individuals without regard to the
p.001539: claims experience of those individuals, employers and their employees (and their dependents) or any health
p.001539: status-related factor relating to such individuals em- ployees and dependents.
p.001539: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—An issuer, upon denying health insurance coverage in any
p.001539: service area in accordance with paragraph (1)(B), may not offer cov- erage in the group or individual
p.001539: market within such service area for a period of 180 days after the date such coverage is denied.
p.001539: (d) APPLICATION OF FINANCIAL CAPACITY LIMITS.—
p.001539: (1) IN GENERAL.—A health insurance issuer may deny health insurance coverage in the group or individual market
p.001539: if the issuer has demonstrated, if required, to the applicable State authority that—
p.001539: (A) it does not have the financial reserves necessary to underwrite additional coverage; and
p.001539: (B) it is applying this paragraph uniformly to all em- ployers and individuals in the group or
p.001539: individual market in the State consistent with applicable State law and with- out regard to the claims experience
p.001539: of those individuals, employers and their employees (and their dependents) or any health status-related
p.001539: factor relating to such individ- uals, employees and dependents.
p.001539: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—A health insurance issuer upon denying health
p.001539: insurance cov- erage in connection with group health plans in accordance with paragraph (1) in a State may not
p.001539: offer coverage in connection with group health plans in the group or individual market in the State for a
p.001539: period of 180 days after the date such coverage is denied or until the issuer has demonstrated to the applicable State
p.001539: authority, if required under applicable State law, that the issuer has sufficient financial reserves to
p.001539: underwrite addi- tional coverage, whichever is later. An applicable State author- ity may provide for the application
p.001539: of this subsection on a serv- ice-area-specific basis.
p.001539: SEC. 2703. ø300gg–2¿ GUARANTEED RENEWABILITY OF COVERAGE.
p.001539: (a) IN GENERAL.—Except as provided in this section, if a health insurance issuer offers health insurance coverage in
p.001539: the individual or group market, the issuer must renew or continue in force such coverage at the option of
p.001539: the plan sponsor or the individual, as ap- plicable.
p.001539: (b) GENERAL EXCEPTIONS.—A health insurance issuer may nonrenew or discontinue health insurance
p.001539: coverage offered in con- nection with a health insurance coverage offered in the group or in- dividual market based
p.001539: only on one or more of the following:
p.001539: (1) NONPAYMENT OF PREMIUMS.—The plan sponsor, or indi- vidual, as applicable, has failed to pay premiums or
p.001539: contribu- tions in accordance with the terms of the health insurance cov- erage or the issuer has not received timely
p.001539: premium payments.
p.001539: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001539:
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p.001539: Sec. 2703 PUBLIC HEALTH SERVICE ACT 1540
p.001539:
p.001539: (2) FRAUD.—The plan sponsor, or individual, as applicable, has performed an act or practice that constitutes
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p.001541: 1541
p.001541: PUBLIC HEALTH SERVICE ACT
p.001541: Sec. 2704
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p.001541: paragraph (B), the issuer acts uniformly without regard to the claims experience of those sponsors or
p.001541: individuals, as applicable, or any health status-related factor relating to any participants or
p.001541: beneficiaries covered or new partici- pants or beneficiaries who may become eligible for such coverage.
p.001541: (2) DISCONTINUANCE OF ALL COVERAGE.—
p.001541: (A) IN GENERAL.—In any case in which a health insur- ance issuer elects to discontinue offering all health
p.001541: insur- ance coverage in the individual or group market, or all markets, in a State, health insurance coverage
p.001541: may be dis- continued by the issuer only in accordance with applicable State law and if—
p.001541: (i) the issuer provides notice to the applicable State authority and to each plan sponsor or individual, as
p.001541: applicable, (and participants and beneficiaries cov- ered under such coverage) of such discontinuation at
p.001541: least 180 days prior to the date of the discontinuation of such coverage; and
p.001541: (ii) all health insurance issued or delivered for issuance in the State in such market (or markets) are
p.001541: discontinued and coverage under such health insur- ance coverage in such market (or markets) is not re-
p.001541: newed.
p.001541: (B) PROHIBITION ON MARKET REENTRY.—In the case of a discontinuation under subparagraph (A) in a market, the
p.001541: issuer may not provide for the issuance of any health in- surance coverage in the market and State involved
p.001541: during the 5-year period beginning on the date of the discontinu- ation of the last health insurance coverage not so
p.001541: renewed.
p.001541: (d) EXCEPTION FOR UNIFORM MODIFICATION OF COVERAGE.—At the time of coverage renewal, a health insurance issuer may
p.001541: modify the health insurance coverage for a product offered to a group health plan—
p.001541: (1) in the large group market; or
p.001541: (2) in the small group market if, for coverage that is avail- able in such market other than only through one or more
p.001541: bona fide associations, such modification is consistent with State law and effective on a uniform basis among
p.001541: group health plans with that product.
p.001541: (e) APPLICATION TO COVERAGE OFFERED ONLY THROUGH ASSO- CIATIONS.—In applying this section in the case of health
p.001541: insurance coverage that is made available by a health insurance issuer in the small or large group market to employers
p.001541: only through one or more associations, a reference to ‘‘plan sponsor’’ is deemed, with respect to coverage
...

p.001549: individual health insurance coverage, may not adjust pre- mium or contribution amounts for the group covered
p.001549: under such plan on the basis of genetic information.
p.001549: (B) RULE OF CONSTRUCTION.—Nothing in subpara- graph (A) or in paragraphs (1) and (2) of subsection
p.001549: (d) shall be construed to limit the ability of a health insurance issuer offering group or individual health
p.001549: insurance cov- erage to increase the premium for an employer based on the manifestation of a disease or
p.001549: disorder of an individual who is enrolled in the plan. In such case, the manifestation of a disease or disorder in
p.001549: one individual cannot also be used as genetic information about other group members and to further increase
p.001549: the premium for the employer.
p.001549: (c) GENETIC TESTING.—
p.001549: (1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A group health plan, and a health
p.001549: insurance issuer
p.001549: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001551: 1551
p.001551: PUBLIC HEALTH SERVICE ACT
p.001551: Sec. 2705
p.001551:
p.001551: offering health insurance coverage in connection with a group health plan, shall not request or require
p.001551: an individual or a family member of such individual to undergo a genetic test.
p.001551: (2) RULE OF CONSTRUCTION.—Paragraph (1) shall not be construed to limit the authority of a health care
p.001551: professional who is providing health care services to an individual to re- quest that such individual undergo
p.001551: a genetic test.
p.001551: (3) RULE OF CONSTRUCTION REGARDING PAYMENT.—
p.001551: (A) IN GENERAL.—Nothing in paragraph (1) shall be construed to preclude a group health plan, or a health in-
p.001551: surance issuer offering health insurance coverage in con- nection with a group health plan, from
p.001551: obtaining and using the results of a genetic test in making a determina- tion regarding payment (as such term is
p.001551: defined for the purposes of applying the regulations promulgated by the Secretary under part C of title
p.001551: XI of the Social Security Act and section 264 of the Health Insurance Portability and Accountability Act
p.001551: of 1996, as may be revised from time to time) consistent with subsection (a).
p.001551: (B) LIMITATION.—For purposes of subparagraph (A), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request only the minimum
p.001551: amount of in- formation necessary to accomplish the intended purpose.
p.001551: (4) RESEARCH EXCEPTION.—Notwithstanding paragraph (1), a group health plan, or a health insurance issuer
p.001551: offering health insurance coverage in connection with a group health plan, may request, but not require, that a
p.001551: participant or bene- ficiary undergo a genetic test if each of the following conditions is met:
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p.001569: of Health and Human Services for such issuers.
p.001569: (b) EXTERNAL REVIEW.—A group health plan and a health in- surance issuer offering group or individual
p.001569: health insurance cov- erage—
p.001569: (1) shall comply with the applicable State external review process for such plans and issuers that, at
p.001569: a minimum, in- cludes the consumer protections set forth in the Uniform Ex- ternal Review Model Act
p.001569: promulgated by the National Associa- tion of Insurance Commissioners and is binding on such plans; or
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p.001569: January 30, 2020
p.001569: (2) shall implement an effective external review process that meets minimum standards established by the
p.001569: Secretary through guidance and that is similar to the process described under paragraph (1)—
p.001569: (A) if the applicable State has not established an ex- ternal review process that meets the requirements of
p.001569: para- graph (1); or
p.001569: (B) if the plan is a self-insured plan that is not subject to State insurance regulation (including a State law
p.001569: that
p.001569: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001571: 1571
p.001571: PUBLIC HEALTH SERVICE ACT
p.001571: Sec. 2719A
p.001571:
p.001571: establishes an external review process described in para- graph (1)).
p.001571: (c) SECRETARY AUTHORITY.—The Secretary may deem the ex- ternal review process of a group health plan or
p.001571: health insurance issuer, in operation as of the date of enactment of this section, to be in compliance
p.001571: with the applicable process established under sub- section (b), as determined appropriate by the Secretary.
p.001571: SEC. 2719A. ø300gg–19a¿ PATIENT PROTECTIONS.
p.001571: (a) CHOICE OF HEALTH CARE PROFESSIONAL.—If a group health plan, or a health insurance issuer offering group
p.001571: or individual health insurance coverage, requires or provides for designation by a participant, beneficiary,
p.001571: or enrollee of a participating primary care provider, then the plan or issuer shall permit each participant,
p.001571: beneficiary, and enrollee to designate any participating primary care provider who is available to accept such
p.001571: individual.
p.001571: (b) COVERAGE OF EMERGENCY SERVICES.—
p.001571: (1) IN GENERAL.—If a group health plan, or a health insur- ance issuer offering group or individual health
p.001571: insurance issuer, provides or covers any benefits with respect to services in an emergency department of a
p.001571: hospital, the plan or issuer shall cover emergency services (as defined in paragraph (2)(B))—
p.001571: (A) without the need for any prior authorization deter- mination;
p.001571: (B) whether the health care provider furnishing such services is a participating provider with respect to
p.001571: such services;
p.001571: (C) in a manner so that, if such services are provided to a participant, beneficiary, or enrollee—
...

p.001589: (1) TREATMENT AS A GROUP HEALTH PLAN.—Any plan, fund, or program which would not be (but for this subsection) an
p.001589: em- ployee welfare benefit plan and which is established or main- tained by a partnership, to the extent that
p.001589: such plan, fund, or program provides medical care (including items and services paid for as medical care)
p.001589: to present or former partners in the partnership or to their dependents (as defined under the terms of the
p.001589: plan, fund, or program), directly or through insurance, reimbursement, or otherwise, shall be treated (subject
p.001589: to para- graph (2)) as an employee welfare benefit plan which is a group health plan.
p.001589: (2) EMPLOYER.—In the case of a group health plan, the term ‘‘employer’’ also includes the partnership in
p.001589: relation to any partner.
p.001589: (3) PARTICIPANTS OF GROUP HEALTH PLANS.—In the case of a group health plan, the term ‘‘participant’’ also includes—
p.001589: (A) in connection with a group health plan maintained by a partnership, an individual who is a partner in
p.001589: rela- tion to the partnership, or
p.001589: (B) in connection with a group health plan maintained by a self-employed individual (under which one or more
p.001589: employees are participants), the self-employed individual,
p.001589: if such individual is, or may become, eligible to receive a ben- efit under the plan or such individual’s
p.001589: beneficiaries may be el- igible to receive any such benefit.
p.001589: SEC. 2723. ø300gg–22¿ ENFORCEMENT.
p.001589: (a) STATE ENFORCEMENT.—
p.001589: (1) STATE AUTHORITY.—Subject to section 2723, each State may require that health insurance issuers that issue,
p.001589: sell, renew, or offer health insurance coverage in the State in the individual or group market meet the
p.001589: requirements of this part with respect to such issuers.
p.001589:
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p.001589: January 30, 2020
p.001589: 18 Section 1563 (relating to conforming amendments--originally designated as section 1562 and redesignated as section
p.001589: 1563 by section 10107(b)(1)) of Public Law 111–148 provides for an amendment to insert ‘‘or, with
p.001589: respect to individual coverage, under any health insurance cov- erage maintained by the same health insurance
p.001589: issuer’’. Such amendment did not specify where to insert this new language, however, it was carried out by inserting
p.001589: this new language before the period at the end in order to reflect the probable intent of Congress.
p.001589: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001589: Sec. 2723 PUBLIC HEALTH SERVICE ACT 1590
p.001589:
p.001589: (2) FAILURE TO IMPLEMENT PROVISIONS.—In the case of a determination by the Secretary that a State has failed to
p.001589: sub- stantially enforce a provision (or provisions) in this part with respect to health insurance issuers in
p.001589: the State, the Secretary shall enforce such provision (or provisions) under subsection (b) insofar as they relate to
p.001589: the issuance, sale, renewal, and offer- ing of health insurance coverage in connection with group health plans
p.001589: or individual health insurance coverage in such State.
p.001589: (b) SECRETARIAL ENFORCEMENT AUTHORITY.—
p.001589: (1) LIMITATION.—The provisions of this subsection shall apply to enforcement of a provision (or provisions) of
p.001589: this part only—
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p.001589: (A) as provided under subsection (a)(2); and
p.001589: (B) with respect to individual health insurance cov- erage or group health plans that are non-Federal
p.001589: govern- mental plans.
p.001589: (2) IMPOSITION OF PENALTIES.—In the cases described in paragraph (1)—
p.001589: (A) IN GENERAL.—Subject to the succeeding provisions of this subsection, any non-Federal governmental plan that is a
p.001589: group health plan and any health insurance issuer that fails to meet a provision of this part
p.001589: applicable to such plan or issuer is subject to a civil money penalty under this subsection.
p.001589: (B) LIABILITY FOR PENALTY.—In the case of a failure by—
p.001589: (i) a health insurance issuer, the issuer is liable for such penalty, or
p.001589: (ii) a group health plan that is a non-Federal gov- ernmental plan which is—
p.001589: (I) sponsored by 2 or more employers, the plan is liable for such penalty, or
p.001589: (II) not so sponsored, the employer is liable for such penalty.
p.001589: (C) AMOUNT OF PENALTY.—
p.001589: (i) IN GENERAL.—The maximum amount of penalty imposed under this paragraph is $100 for each day for each individual
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p.001591: Sec. 2723 PUBLIC HEALTH SERVICE ACT 1592
p.001591: (F) FAILURE TO PAY ASSESSMENT; MAINTENANCE OF AC- TION.—
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p.001591: January 30, 2020
p.001591: (i) FAILURE TO PAY ASSESSMENT.—If any entity fails to pay an assessment after it has become a final and
p.001591: unappealable order, or after the court has entered final judgment in favor of the Secretary, the Secretary shall refer
p.001591: the matter to the Attorney General who shall recover the amount assessed by action in the ap- propriate United
p.001591: States district court.
p.001591: (ii) NONREVIEWABILITY.—In such action the valid- ity and appropriateness of the final order imposing the
p.001591: penalty shall not be subject to review.
p.001591: (G) PAYMENT OF PENALTIES.—Except as otherwise pro- vided, penalties collected under this paragraph shall be paid
p.001591: to the Secretary (or other officer) imposing the pen- alty and shall be available without appropriation and
p.001591: until expended for the purpose of enforcing the provisions with respect to which the penalty was imposed.
p.001591: (3) ENFORCEMENT AUTHORITY RELATING TO GENETIC DIS- CRIMINATION.—
p.001591: (A) GENERAL RULE.—In the cases described in para- graph (1), notwithstanding the provisions of paragraph
p.001591: (2)(C), the succeeding subparagraphs of this paragraph shall apply with respect to an action under this
p.001591: subsection by the Secretary with respect to any failure of a health in- surance issuer in connection with a group
p.001591: health plan, to meet the requirements of subsection (a)(1)(F), (b)(3), (c), or
p.001591: (d) of section 2702 or section 2701 or 2702(b)(1) with re- spect to genetic information in connection with
p.001591: the plan.
p.001591: (B) AMOUNT.—
p.001591: (i) IN GENERAL.—The amount of the penalty im- posed under this paragraph shall be $100 for each day in the
p.001591: noncompliance period with respect to each par- ticipant or beneficiary to whom such failure relates.
p.001591: (ii) NONCOMPLIANCE PERIOD.—For purposes of this paragraph, the term ‘‘noncompliance period’’ means, with respect
p.001591: to any failure, the period—
p.001591: (I) beginning on the date such failure first oc- curs; and
p.001591: (II) ending on the date the failure is corrected.
p.001591: (C) MINIMUM PENALTIES WHERE FAILURE DISCOV- ERED.—Notwithstanding clauses (i) and (ii) of subpara-
p.001591: graph (D):
p.001591: (i) IN GENERAL.—In the case of 1 or more failures with respect to an individual—
p.001591: (I) which are not corrected before the date on which the plan receives a notice from the Sec- retary of such
p.001591: violation; and
p.001591: (II) which occurred or continued during the period involved;
p.001591: the amount of penalty imposed by subparagraph (A) by reason of such failures with respect to such indi-
p.001591: vidual shall not be less than $2,500.
p.001591: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001597: than 120 percent of a weighted average (described in sub- paragraph (D)).
p.001597: (D) WEIGHTED AVERAGE.—For purposes of this paragraph, the weighted average described in this sub-
p.001597: paragraph is the average actuarial value of the benefits provided by all the health insurance coverage
p.001597: issued (as elected by the issuer) either by that issuer or by all issuers in the State in the individual market
p.001597: during the previous year (not including coverage issued under this section), weighted by enrollment for the
p.001597: different coverage.
p.001597: (4) ELECTION.—The issuer elections under this subsection shall apply uniformly to all eligible individuals in the
p.001597: State for that issuer. Such an election shall be effective for policies of- fered during a period of not
p.001597: shorter than 2 years.
p.001597: (5) ASSUMPTIONS.—For purposes of paragraph (3), the ac- tuarial value of benefits provided under
p.001597: individual health in- surance coverage shall be calculated based on a standardized population and a set
p.001597: of standardized utilization and cost fac- tors.
p.001597: (d) SPECIAL RULES FOR NETWORK PLANS.—
p.001597: (1) IN GENERAL.—In the case of a health insurance issuer that offers health insurance coverage in the
p.001597: individual market through a network plan, the issuer may—
p.001597: (A) limit the individuals who may be enrolled under such coverage to those who live, reside, or work within the
p.001597: service area for such network plan; and
p.001597: (B) within the service area of such plan, deny such coverage to such individuals if the issuer
p.001597: has dem- onstrated, if required, to the applicable State authority that—
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p.001597: January 30, 2020
p.001597: (i) it will not have the capacity to deliver services adequately to additional individual enrollees because of
p.001597: its obligations to existing group contract holders and enrollees and individual enrollees, and
p.001597: (ii) it is applying this paragraph uniformly to indi- viduals without regard to any health status-related factor
p.001597: of such individuals and without regard to whether the individuals are eligible individuals.
p.001597: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—An issuer, upon denying health insurance coverage in any
p.001597: service area in accordance with paragraph (1)(B), may not offer cov- erage in the individual market
p.001597: within such service area for a period of 180 days after such coverage is denied.
p.001597: (e) APPLICATION OF FINANCIAL CAPACITY LIMITS.—
p.001597: (1) IN GENERAL.—A health insurance issuer may deny health insurance coverage in the individual market to an
p.001597: eligi- ble individual if the issuer has demonstrated, if required, to the applicable State authority that—
p.001597: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001597: Sec. 2742 PUBLIC HEALTH SERVICE ACT 1598
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p.001597: (A) it does not have the financial reserves necessary to underwrite additional coverage; and
p.001597: (B) it is applying this paragraph uniformly to all indi- viduals in the individual market in the State
p.001597: consistent with applicable State law and without regard to any health status-related factor of such
p.001597: individuals and with- out regard to whether the individuals are eligible individ- uals.
p.001597: (2) 180-DAY SUSPENSION UPON DENIAL OF COVERAGE.—An issuer upon denying individual health insurance coverage
p.001597: in any service area in accordance with paragraph (1) may not offer such coverage in the individual market
p.001597: within such serv- ice area for a period of 180 days after the date such coverage is denied or until the
p.001597: issuer has demonstrated, if required under applicable State law, to the applicable State authority that
p.001597: the issuer has sufficient financial reserves to underwrite additional coverage, whichever is later. A
p.001597: State may provide for the application of this paragraph on a service-area-specific basis.
p.001597: (e) 22 MARKET REQUIREMENTS.—
p.001597: (1) IN GENERAL.—The provisions of subsection (a) shall not be construed to require that a health insurance issuer
p.001597: offering health insurance coverage only in connection with group health plans or through one or more bona fide
p.001597: associations, or both, offer such health insurance coverage in the individual market.
p.001597: (2) CONVERSION POLICIES.—A health insurance issuer of- fering health insurance coverage in connection
p.001597: with group health plans under this title shall not be deemed to be a health insurance issuer offering individual
p.001597: health insurance coverage solely because such issuer offers a conversion policy.
p.001597: (f) 22 CONSTRUCTION.—Nothing in this section shall be con- strued—
p.001597: (1) to restrict the amount of the premium rates that an issuer may charge an individual for health insurance
p.001597: coverage provided in the individual market under applicable State law; or
p.001597: (2) to prevent a health insurance issuer offering health in- surance coverage in the individual market from
p.001597: establishing premium discounts or rebates or modifying otherwise applica- ble copayments or deductibles in
p.001597: return for adherence to pro- grams of health promotion and disease prevention.
p.001597: SEC. 2742. ø300gg–42¿ GUARANTEED RENEWABILITY OF INDIVIDUAL HEALTH INSURANCE COVERAGE.
p.001597: (a) IN GENERAL.—Except as provided in this section, a health insurance issuer that provides individual health
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p.001599: under this paragraph uniformly without regard to any health status-related factor of covered individ- uals.
p.001599: (c) REQUIREMENTS FOR UNIFORM TERMINATION OF COVERAGE.—
p.001599: (1) PARTICULAR TYPE OF COVERAGE NOT OFFERED.—In any case in which an issuer decides to discontinue
p.001599: offering a par- ticular type of health insurance coverage offered in the indi- vidual market, coverage of
p.001599: such type may be discontinued by the issuer only if—
p.001599: (A) the issuer provides notice to each covered indi- vidual provided coverage of this type in such
p.001599: market of such discontinuation at least 90 days prior to the date of the discontinuation of such coverage;
p.001599: (B) the issuer offers to each individual in the indi- vidual market provided coverage of this type, the option
p.001599: to purchase any other individual health insurance coverage currently being offered by the issuer for
p.001599: individuals in such market; and
p.001599: (C) in exercising the option to discontinue coverage of this type and in offering the option of coverage under
p.001599: sub- paragraph (B), the issuer acts uniformly without regard to any health status-related factor of enrolled
p.001599: individuals or individuals who may become eligible for such coverage.
p.001599: (2) DISCONTINUANCE OF ALL COVERAGE.—
p.001599: (A) IN GENERAL.—Subject to subparagraph (C), in any case in which a health insurance issuer elects to dis-
p.001599: continue offering all health insurance coverage in the indi- vidual market in a State, health insurance coverage
p.001599: may be discontinued by the issuer only if—
p.001599: (i) the issuer provides notice to the applicable State authority and to each individual of such dis-
p.001599: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001599: Sec. 2743 PUBLIC HEALTH SERVICE ACT 1600
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p.001599: January 30, 2020
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p.001599: continuation at least 180 days prior to the date of the expiration of such coverage, and
p.001599: (ii) all health insurance issued or delivered for issuance in the State in such market are discontinued and
p.001599: coverage under such health insurance coverage in such market is not renewed.
p.001599: (B) PROHIBITION ON MARKET REENTRY.—In the case of a discontinuation under subparagraph (A) in the indi-
p.001599: vidual market, the issuer may not provide for the issuance of any health insurance coverage in the market and State
p.001599: involved during the 5-year period beginning on the date of the discontinuation of the last health insurance
p.001599: coverage not so renewed.
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p.001601: regulatory official of the State, that such a mechanism is not an acceptable alternative mecha- nism or is not
p.001601: (or no longer) being implemented, the Sec- retary—
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p.001601: January 30, 2020
p.001601: (A) shall notify the State of—
p.001601: (i) such preliminary determination, and
p.001601: (ii) the consequences under paragraph (3) of a fail- ure to implement such a mechanism; and
p.001601: (B) shall permit the State a reasonable opportunity in which to modify the mechanism (or to adopt another mech- anism)
p.001601: in a manner so that may be an acceptable alter- native mechanism or to provide for implementation of such a
p.001601: mechanism.
p.001601: (3) FINAL DETERMINATION.—If, after providing notice and opportunity under paragraph (2), the Secretary
p.001601: finds that the mechanism is not an acceptable alternative mechanism or the State is not implementing such
p.001601: a mechanism, the Secretary shall notify the State that the State is no longer considered to be implementing an
p.001601: acceptable alternative mechanism and that the requirements of section 2741 shall apply to health in- surance
p.001601: coverage offered in the individual market in the State, effective as of a date specified in the notice.
p.001601: (4) LIMITATION ON SECRETARIAL AUTHORITY.—The Sec- retary shall not make a determination under paragraph
p.001601: (2) or
p.001601: (3) on any basis other than the basis that a mechanism is not an acceptable alternative mechanism or is not
p.001601: being imple- mented.
p.001601: (5) FUTURE ADOPTION OF MECHANISMS.—If a State, after January 1, 1997, submits the notice and information
p.001601: described in paragraph (1), unless the Secretary makes a finding de- scribed in paragraph (3) within the
p.001601: 90-day period beginning on the date of submission of the notice and information, the mech- anism shall be
p.001601: considered to be an acceptable alternative mechanism for purposes of this section, effective 90 days after
p.001601: the end of such period, subject to the second sentence of para- graph (1).
p.001601: (c) PROVISION RELATED TO RISK.—
p.001601: (1) ADOPTION OF NAIC MODELS.—The model act referred to in subsection (a)(1)(D)(i) is the Small Employer and
p.001601: Individual Health Insurance Availability Model Act (adopted by the Na- tional Association of Insurance
p.001601: Commissioners on June 3, 1996) insofar as it applies to individual health insurance cov- erage or the
p.001601: Individual Health Insurance Portability Model Act (also adopted by such Association on such date).
p.001601: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001603: 1603
p.001603: PUBLIC HEALTH SERVICE ACT
p.001603: Sec. 2745
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p.001607: such individual where such family member is covered under the policy that covers such individual. In such case, the
p.001607: manifestation of a disease or disorder in one indi- vidual cannot also be used as genetic information
p.001607: about other individuals covered under the policy issued to such individual and to further increase premiums or
p.001607: contribution amounts.
p.001607: (c) PROHIBITION ON GENETIC INFORMATION AS PREEXISTING CONDITION.—
p.001607: (1) IN GENERAL.—A health insurance issuer offering health insurance coverage in the individual market may not,
p.001607: on the basis of genetic information, impose any preexisting condition exclusion (as defined in section
p.001607: 2701(b)(1)(A)) with respect to such coverage.
p.001607: (2) RULE OF CONSTRUCTION.—Nothing in paragraph (1) or in paragraphs (1) and (2) of subsection (e)
p.001607: shall be construed to preclude a health insurance issuer from imposing any pre- existing condition
p.001607: exclusion for an individual with respect to health insurance coverage on the basis of a manifestation of a
p.001607: disease or disorder in that individual.
p.001607: (d) GENETIC TESTING.—
p.001607: (1) LIMITATION ON REQUESTING OR REQUIRING GENETIC TESTING.—A health insurance issuer offering health
p.001607: insurance coverage in the individual market shall not request or require an individual or a family member of such
p.001607: individual to undergo a genetic test.
p.001607: (2) RULE OF CONSTRUCTION.—Paragraph (1) shall not be construed to limit the authority of a health care
p.001607: professional who is providing health care services to an individual to re- quest that such individual undergo
p.001607: a genetic test.
p.001607: (3) RULE OF CONSTRUCTION REGARDING PAYMENT.—
p.001607: (A) IN GENERAL.—Nothing in paragraph (1) shall be construed to preclude a health insurance issuer
p.001607: offering health insurance coverage in the individual market from obtaining and using the results of a genetic
p.001607: test in making a determination regarding payment (as such term is de- fined for the purposes of applying the
p.001607: regulations promul- gated by the Secretary under part C of title XI of the So- cial Security Act and
p.001607: section 264 of the Health Insurance Portability and Accountability Act of 1996, as may be re- vised from
p.001607: time to time) consistent with subsection (a) and (c).
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p.001607: January 30, 2020
p.001607: (B) LIMITATION.—For purposes of subparagraph (A), a health insurance issuer offering health insurance coverage in
p.001607: the individual market may request only the minimum amount of information necessary to accomplish the in-
p.001607: tended purpose.
p.001607: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001609: 1609
p.001609: PUBLIC HEALTH SERVICE ACT
p.001609: Sec. 2753
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p.001609: violation of paragraph (2) if such request, require- ment, or purchase is not in violation of paragraph (1).
p.001609: (f) GENETIC INFORMATION OF A FETUS OR EMBRYO.—Any ref- erence in this part to genetic information concerning an
p.001609: individual or family member of an individual shall—
p.001609: (1) with respect to such an individual or family member of an individual who is a pregnant woman, include genetic
p.001609: infor- mation of any fetus carried by such pregnant woman; and
p.001609: (2) with respect to an individual or family member uti- lizing an assisted reproductive technology,
p.001609: include genetic in- formation of any embryo legally held by the individual or fam- ily member.
p.001609: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001609: Sec. 2761 PUBLIC HEALTH SERVICE ACT 1610
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p.001609: Subpart 3—General Provisions 25
p.001609: SEC. 2761. ø300gg–61¿ ENFORCEMENT.
p.001609: (a) STATE ENFORCEMENT.—
p.001609: (1) STATE AUTHORITY.—Subject to section 2762, each State may require that health insurance issuers that issue,
p.001609: sell, renew, or offer health insurance coverage in the State in the individual market meet the
p.001609: requirements established under this part with respect to such issuers.
p.001609: (2) FAILURE TO IMPLEMENT REQUIREMENTS.—In the case of a State that fails to substantially enforce the requirements
p.001609: set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the
p.001609: requirements of this part under subsection (b) insofar as they relate to the issuance, sale, renewal, and offering of
p.001609: health insurance coverage in the individual market in such State.
p.001609: (b) SECRETARIAL ENFORCEMENT AUTHORITY.—The Secretary shall have the same authority in relation to enforcement
p.001609: of the pro- visions of this part with respect to issuers of health insurance cov- erage in the individual market
p.001609: in a State as the Secretary has under section 2722(b)(2), and section 2722(b)(3) with respect to vio- lations of
p.001609: genetic nondiscrimination provisions, in relation to the enforcement of the provisions of part A with
p.001609: respect to issuers of health insurance coverage in the small group market in the State.
p.001609: SEC. 2762. ø300gg–62¿ PREEMPTION. 26
p.001609: (a) IN GENERAL.—Subject to subsection (b), nothing in this part (or part C insofar as it applies to this part)
p.001609: shall be construed to prevent a State from establishing, implementing, or continuing in effect standards
p.001609: and requirements unless such standards and re- quirements prevent the application of a requirement of
p.001609: this part.
p.001609: (b) RULES OF CONSTRUCTION.—(1) Nothing in this part (or part C insofar as it applies to this part) shall
p.001609: be construed to affect or modify the provisions of section 514 of the Employee Retirement Income Security
p.001609: Act of 1974 (29 U.S.C. 1144).
p.001609: (2) Nothing in this part (other than section 2751) shall be con- strued as requiring health insurance coverage
p.001609: offered in the indi- vidual market to provide specific benefits under the terms of such coverage.
p.001609: (c) APPLICATION OF PART A PROVISIONS.— 27
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p.001609: 25 Section 605(a)(3) of Public Law 104–204 (110 Stat. 2941) adds this subpart designation and heading to part B.
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p.001613: (C) Liability insurance, including general liability in- surance and automobile liability insurance.
p.001613: (D) Workers’ compensation or similar insurance.
p.001613: (E) Automobile medical payment insurance.
p.001613: (F) Credit-only insurance.
p.001613: (G) Coverage for on-site medical clinics.
p.001613: (H) Other similar insurance coverage, specified in reg- ulations, under which benefits for medical care are
p.001613: sec- ondary or incidental to other insurance benefits.
p.001613: (2) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED SEPARATELY.—
p.001613: (A) Limited scope dental or vision benefits.
p.001613: (B) Benefits for long-term care, nursing home care, home health care, community-based care, or any combina- tion
p.001613: thereof.
p.001613: (C) Such other similar, limited benefits as are speci- fied in regulations.
p.001613: (3) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS INDEPENDENT, NONCOORDINATED BENEFITS.—
p.001613: (A) Coverage only for a specified disease or illness.
p.001613: (B) Hospital indemnity or other fixed indemnity insurance.
p.001613: (4) BENEFITS NOT SUBJECT TO REQUIREMENTS IF OFFERED AS SEPARATE INSURANCE POLICY.—Medicare
p.001613: supplemental health insurance (as defined under section 1882(g)(1) of the So- cial Security Act), coverage
p.001613: supplemental to the coverage pro- vided under chapter 55 of title 10, United States Code, and similar
p.001613: supplemental coverage provided to coverage under a group health plan.
p.001613: (d) 29 OTHER DEFINITIONS.—
p.001613: (1) APPLICABLE STATE AUTHORITY.—The term ‘‘applicable State authority’’ means, with respect to a health
p.001613: insurance issuer in a State, the State insurance commissioner or official or officials designated by the State
p.001613: to enforce the requirements of this title for the State involved with respect to such issuer.
p.001613: (2) BENEFICIARY.—The term ‘‘beneficiary’’ has the meaning given such term under section 3(8) of the Employee Retirement
p.001613: Income Security Act of 1974.
p.001613: (3) BONA FIDE ASSOCIATION.—The term ‘‘bona fide associa- tion’’ means, with respect to health insurance coverage
p.001613: offered in a State, an association which—
p.001613: (A) has been actively in existence for at least 5 years;
p.001613: (B) has been formed and maintained in good faith for purposes other than obtaining insurance;
p.001613: (C) does not condition membership in the association on any health status-related factor relating to an
p.001613: indi- vidual (including an employee of an employer or a depend- ent of an employee);
p.001613:
p.001613:
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p.001613:
p.001613: January 30, 2020
p.001613: 29 For version of law for section 2791(d)(20)–(21) (as amended by section 1563(b) (relating to conforming
p.001613: amendments--originally designated as section 1562 and redesignated as section 1563 by section 10107(b)(1)) of
p.001613: Public Law 111–148) see note set out in italic typeface that appears after paragraph (19).
p.001613: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001621: January 30, 2020
p.001621: SEC. 2801. ø42 U.S.C. 300hh¿ PUBLIC HEALTH AND MEDICAL PRE- PAREDNESS AND RESPONSE FUNCTIONS.
p.001621: (a) IN GENERAL.—The Secretary of Health and Human Serv- ices shall lead all Federal public health and
p.001621: medical response to public health emergencies and incidents covered by the National Response Plan developed
p.001621: pursuant to section 502(6) of the Home- land Security Act of 2002, or any successor plan.
p.001621: (b) INTERAGENCY AGREEMENT.—The Secretary, in collaboration with the Secretary of Veterans Affairs, the
p.001621: Secretary of Transpor- tation, the Secretary of Defense, the Secretary of Homeland Secu- rity, and the
p.001621: head of any other relevant Federal agency, shall es- tablish an interagency agreement, consistent with the
p.001621: National Re- sponse Plan or any successor plan, under which agreement the Sec- retary of Health and Human Services
p.001621: shall assume operational control of emergency public health and medical response assets, as necessary, in the
p.001621: event of a public health emergency, except that members of the armed forces under the authority of the
p.001621: Secretary of Defense shall remain under the command and control of the Sec- retary of Defense, as shall any associated
p.001621: assets of the Department of Defense.
p.001621: SEC. 2802. ø42 U.S.C. 300hh–1¿ NATIONAL HEALTH SECURITY STRAT- EGY.
p.001621: (a) IN GENERAL.—
p.001621: (1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC HEALTH EMERGENCIES.—Beginning in 2018 and
p.001621: every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a
p.001621: coordinated strategy (to be known as the National Health Security Strategy) and any revi- sions thereof, and an
p.001621: accompanying implementation plan for public health emergency preparedness and response. Such Na- tional Health
p.001621: Security Strategy shall describe potential emer- gency health security threats and identify the
p.001621: process for achieving the preparedness goals described in subsection (b) to be prepared to identify and respond
p.001621: to such threats and shall be consistent with the national preparedness goal (as described in section 504(a)(19)
p.001621: of the Homeland Security Act of 2002), the National Incident Management System (as defined in sec- tion
p.001621: 501(7) of such Act), and the National Response Plan devel- oped pursuant to section 504 of such Act, or any
p.001621: successor plan.
p.001621: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001621:
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p.001623: preparedness and response capa- bilities, as applicable.
p.001623: (10) GLOBAL HEALTH SECURITY.—Assessing current or po- tential health security threats from abroad to inform
p.001623: domestic public health preparedness and response capabilities.
p.001623: SEC. 2803. ø42 U.S.C. 300hh–2¿ ENHANCING MEDICAL SURGE CAPACITY.
p.001623: (a) STUDY OF ENHANCING MEDICAL SURGE CAPACITY.—As part of the joint review described in section 2812(b), the
p.001623: Secretary shall evaluate the benefits and feasibility of improving the capacity of the Department of Health
p.001623: and Human Services to provide addi- tional medical surge capacity to local communities in the event of
p.001623: a public health emergency. Such study shall include an assessment of the need for and feasibility of
p.001623: improving surge capacity through—
p.001623: (1) acquisition and operation of mobile medical assets by the Secretary to be deployed, on a contingency basis,
p.001623: to a com- munity in the event of a public health emergency;
p.001623: (2) integrating the practice of telemedicine within the Na- tional Disaster Medical System; and
p.001623: (3) other strategies to improve such capacity as determined appropriate by the Secretary.
p.001623: (b) AUTHORITY TO ACQUIRE AND OPERATE MOBILE MEDICAL AS- SETS.—In addition to any other authority to
p.001623: acquire, deploy, and operate mobile medical assets, the Secretary may acquire, deploy, and operate mobile
p.001623: medical assets if, taking into consideration the evaluation conducted under subsection (a), such acquisition, deploy-
p.001623: ment, and operation is determined to be beneficial and feasible in improving the capacity of the
p.001623: Department of Health and Human Services to provide additional medical surge capacity to local com-
p.001623: munities in the event of a public health emergency.
p.001623: (c) USING FEDERAL FACILITIES TO ENHANCE MEDICAL SURGE CAPACITY.—
p.001623: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001625: 1625
p.001625: PUBLIC HEALTH SERVICE ACT
p.001625: Sec. 2811
p.001625:
p.001625: (1) ANALYSIS.—The Secretary shall conduct an analysis of whether there are Federal facilities which, in
p.001625: the event of a public health emergency, could practicably be used as facilities in which to provide health care.
p.001625: (2) MEMORANDA OF UNDERSTANDING.—If, based on the analysis conducted under paragraph (1), the
p.001625: Secretary deter- mines that there are Federal facilities which, in the event of a public health emergency,
p.001625: could be used as facilities in which to provide health care, the Secretary shall, with respect to each such facility,
p.001625: seek to conclude a memorandum of under- standing with the head of the Department or agency that oper-
p.001625: ates such facility that permits the use of such facility to pro- vide health care in the event of a public
p.001625: health emergency.
p.001625:
p.001625: Subtitle B—All-Hazards Emergency Preparedness and Response
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p.001625: January 30, 2020
p.001625: SEC. 2811. ø42 U.S.C. 300hh–10¿ COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS PUBLIC HEALTH
p.001625: EMERGENCIES.
p.001625: (a) IN GENERAL.—There is established within the Department of Health and Human Services the position of
p.001625: the Assistant Sec- retary for Preparedness and Response. The President, with the ad- vice and consent of the Senate,
p.001625: shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Sec-
p.001625: retary.
p.001625: (b) DUTIES.—Subject to the authority of the Secretary, the As- sistant Secretary for Preparedness and Response shall
p.001625: utilize expe- rience related to public health emergency preparedness and re- sponse, biodefense, medical
p.001625: countermeasures, and other relevant topics to carry out the following functions:
p.001625: (1) LEADERSHIP.—Serve as the principal advisor to the Sec- retary on all matters related to Federal public health and
p.001625: med- ical preparedness and response for public health emergencies.
p.001625: (2) PERSONNEL.—Register, credential, organize, train, equip, and have the authority to deploy
p.001625: Federal public health and medical personnel under the authority of the Secretary, in- cluding the National
p.001625: Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emer- gency System
p.001625: for Advance Registration of Volunteer Health Professionals.
p.001625: (3) COUNTERMEASURES.—Oversee advanced research, de- velopment, and procurement of qualified countermeasures
p.001625: (as defined in section 319F–1), security countermeasures (as de- fined in section 319F–2), and qualified
p.001625: pandemic or epidemic products (as defined in section 319F–3).
p.001625: (4) COORDINATION.—
p.001625: (A) FEDERAL INTEGRATION.—Coordinate with relevant Federal officials to ensure integration of Federal prepared- ness
p.001625: and response activities for public health emergencies.
p.001625: (B) STATE, LOCAL, AND TRIBAL INTEGRATION.—Coordi- nate with State, local, and tribal public health officials, the
p.001625: Emergency Management Assistance Compact, health care
p.001625: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001625: Sec. 2811 PUBLIC HEALTH SERVICE ACT 1626
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p.001627: potential postdeployment activities related to medical countermeasures;
p.001627: (B) inform prioritization of resources and include measurable outputs and outcomes to allow for the
p.001627: tracking of the progress made toward identified priorities;
p.001627: (C) identify medical countermeasure life-cycle costs to inform planning, budgeting, and anticipated needs
p.001627: within the continuum of the medical countermeasure enterprise consistent with section 319F–2;
p.001627: (D) identify the full range of anticipated medical coun- termeasure needs related to research and development,
p.001627: procurement, and stockpiling, including the potential need for indications, dosing, and administration
p.001627: technologies, and other countermeasure needs as applicable and appro- priate;
p.001627: (E) be made available, not later than March 15 of each year, to the Committee on Appropriations and the Com-
p.001627: mittee on Health, Education, Labor, and Pensions of the Senate and the Committee on Appropriations
p.001627: and the Committee on Energy and Commerce of the House of Rep- resentatives; and
p.001627: (F) not later than March 15 of each year, be made publicly available in a manner that does not
p.001627: compromise national security.
p.001627: (c) FUNCTIONS.—The Assistant Secretary for Preparedness and Response shall—
p.001627: (1) have lead responsibility within the Department of Health and Human Services for emergency
p.001627: preparedness and response policy coordination and strategic direction;
p.001627: (2) have authority over and responsibility for—
p.001627: (A) the National Disaster Medical System pursuant to section 2812;
p.001627: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001629: 1629
p.001629: PUBLIC HEALTH SERVICE ACT
p.001629: Sec. 2811
p.001629:
p.001629: (B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C–2;
p.001629: (C) the Biomedical Advanced Research and Develop- ment Authority pursuant to section 319L;
p.001629: (D) the Medical Reserve Corps pursuant to section 2813;
p.001629: (E) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I; and
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p.001629: January 30, 2020
p.001629: (F) administering grants and related authorities re- lated to trauma care under parts A through C of title XII,
p.001629: such authority to be transferred by the Secretary from the Administrator of the Health Resources and Services
p.001629: Ad- ministration to such Assistant Secretary;
p.001629: (3) exercise the responsibilities and authorities of the Sec- retary with respect to the coordination of—
p.001629: (A) the Public Health Emergency Preparedness Coop- erative Agreement Program pursuant to section 319C–1;
p.001629: (B) the Strategic National Stockpile pursuant to sec- tion 319F–2; and
p.001629: (C) the Cities Readiness Initiative; and
p.001629: (4) assume other duties as determined appropriate by the Secretary.
p.001629: (d) PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTATION PLAN.—
p.001629: (1) IN GENERAL.—Not later than March 15, 2020, and bien- nially thereafter, the Assistant Secretary for Preparedness
p.001629: and Response shall develop and submit to the appropriate commit- tees of Congress a coordinated strategy and
p.001629: accompanying im- plementation plan for medical countermeasures to address chemical, biological,
p.001629: radiological, and nuclear threats. In devel- oping such a plan, the Assistant Secretary for Preparedness and
p.001629: Response shall consult with the Public Health Emergency Medical Countermeasures Enterprise established under section
p.001629: 2811–1. Such strategy and plan shall be known as the ‘‘Public Health Emergency Medical Countermeasures Enterprise
p.001629: Strat- egy and Implementation Plan’’.
p.001629: (2) REQUIREMENTS.—The plan under paragraph (1) shall—
p.001629: (A) describe the chemical, biological, radiological, and nuclear agent or agents that may present a
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p.001629: (H) incorporate input from Federal, State, local, and tribal stakeholders;
p.001629: (I) identify the progress made in meeting the medical countermeasure priorities for at-risk individuals
p.001629: (as de- fined in 2802(b)(4)(B)), as applicable under subparagraph (C), including with regard to the
p.001629: projected needs for re- lated stockpiling and replenishment of the Strategic Na- tional Stockpile, including
p.001629: by addressing the needs of pedi- atric populations with respect to such countermeasures and products in the
p.001629: Strategic National Stockpile, includ- ing—
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p.001629: January 30, 2020
p.001629: (i) a list of such countermeasures and products necessary to address the needs of pediatric popu-
p.001629: lations;
p.001629: (ii) a description of measures taken to coordinate with the Office of Pediatric Therapeutics of the Food
p.001629: and Drug Administration to maximize the labeling, dosages, and formulations of such countermeasures and
p.001629: products for pediatric populations;
p.001629: (iii) a description of existing gaps in the Strategic National Stockpile and the development of such coun- termeasures
p.001629: and products to address the needs of pe- diatric populations; and
p.001629: (iv) an evaluation of the progress made in ad- dressing priorities identified pursuant to subpara-
p.001629: graph (C);
p.001629: (J) identify the use of authority and activities under- taken pursuant to sections 319F–1(b)(1),
p.001629: 319F–1(b)(2), 319F–1(b)(3), 319F–1(c), 319F–1(d), 319F–1(e), 319F– 2(c)(7)(C)(iii), 319F–2(c)(7)(C)(iv),
p.001629: and 319F–2(c)(7)(C)(v) of
p.001629: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001631: 1631
p.001631: PUBLIC HEALTH SERVICE ACT
p.001631: Sec. 2811
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p.001631: this Act, and subsections (a)(1), (b)(1), and (e) of section 564 of the Federal Food, Drug, and Cosmetic Act,
p.001631: by sum- marizing—
p.001631: (i) the particular actions that were taken under the authorities specified, including, as applicable, the
p.001631: identification of the threat agent, emergency, or the biomedical countermeasure with respect to which the
p.001631: authority was used;
p.001631: (ii) the reasons underlying the decision to use such authorities, including, as applicable, the options
p.001631: that were considered and rejected with respect to the use of such authorities;
p.001631: (iii) the number of, nature of, and other informa- tion concerning the persons and entities that
p.001631: received a grant, cooperative agreement, or contract pursuant to the use of such authorities, and the persons and
p.001631: en- tities that were considered and rejected for such a grant, cooperative agreement, or contract, except
p.001631: that the report need not disclose the identity of any such person or entity;
p.001631: (iv) whether, with respect to each procurement that is approved by the President under section 319F– 2(c)(6), a
p.001631: contract was entered into within one year after such approval by the President; and
p.001631: (v) with respect to section 319F–1(d), for the 2- year period for which the report is submitted, the
p.001631: number of persons who were paid amounts totaling
p.001631: $100,000 or greater and the number of persons who were paid amounts totaling at least $50,000 but less
p.001631: than $100,000; and
p.001631: (K) be made publicly available.
p.001631: (3) GAO REPORT.—
p.001631: (A) IN GENERAL.—Not later than 1 year after the date of the submission to the Congress of the first
p.001631: Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan, the Comptroller
p.001631: Gen- eral of the United States shall conduct an independent evaluation, and submit to the appropriate
p.001631: committees of Congress a report, concerning such Strategy and Imple- mentation Plan.
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p.001631: (1) The Assistant Secretary for Preparedness and Re- sponse.
p.001631: (2) The Director of the Centers for Disease Control and Prevention.
p.001631: (3) The Director of the National Institutes of Health.
p.001631: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001633: PUBLIC HEALTH SERVICE ACT
p.001633: Sec. 2811A
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p.001633: January 30, 2020
p.001633: (4) The Commissioner of Food and Drugs.
p.001633: (5) The Secretary of Defense.
p.001633: (6) The Secretary of Homeland Security.
p.001633: (7) The Secretary of Agriculture.
p.001633: (8) The Secretary of Veterans Affairs.
p.001633: (9) The Director of National Intelligence.
p.001633: (10) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced
p.001633: Research and Development Authority, the Director of the Strategic Na- tional Stockpile, the Director of
p.001633: the National Institute of Al- lergy and Infectious Diseases, and the Director of the Office of Public Health
p.001633: Preparedness and Response, as the Secretary de- termines appropriate.
p.001633: (c) FUNCTIONS.—
p.001633: (1) IN GENERAL.—The functions of the PHEMCE shall in- clude the following:
p.001633: (A) Utilize a process to make recommendations to the Secretary regarding research, advanced research, develop-
p.001633: ment, procurement, stockpiling, deployment, distribution, and utilization with respect to countermeasures, as
p.001633: defined in section 319F–2(c), including prioritization based on the health security needs of the
p.001633: United States. Such rec- ommendations shall be informed by, when available and practicable, the National
p.001633: Health Security Strategy pursu- ant to section 2802, the Strategic National Stockpile needs pursuant to section
p.001633: 319F–2, and assessments of current national security threats, including chemical, biological, radiological,
p.001633: and nuclear threats, including emerging infec- tious diseases. In the event that members of the PHEMCE do not agree
p.001633: upon a recommendation, the Secretary shall provide a determination regarding such recommendation.
p.001633: (B) Identify national health security needs, including gaps in public health preparedness and response related to
p.001633: countermeasures and challenges to addressing such needs (including any regulatory challenges), and support
p.001633: align- ment of countermeasure procurement with recommenda- tions to address such needs under subparagraph (A).
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p.001633: (iv) at least one such member shall be an indi- vidual with expertise in the needs of parents or family
p.001633: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001635: PUBLIC HEALTH SERVICE ACT
p.001635: Sec. 2811B
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p.001635: January 30, 2020
p.001635: caregivers, including the parents or caregivers of chil- dren with disabilities.
p.001635: (3) FEDERAL MEMBERS.—The Advisory Committee under paragraph (1) shall include the following Federal members
p.001635: or their designees (who may be nonvoting members, as deter- mined by the Secretary):
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Assistant Secretary of the Administration for Children and Families.
p.001635: (G) The Administrator of the Health Resources and Services Administration.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Administrator of the Administration for Com- munity Living.
p.001635: (J) The Secretary of Education.
p.001635: (K) Representatives from such Federal agencies (such as the Substance Abuse and Mental Health Services
p.001635: Ad- ministration and the Department of Homeland Security) as the Secretary determines appropriate to
p.001635: fulfill the du- ties of the Advisory Committee under subsections (b) and (c).
p.001635: (4) TERM OF APPOINTMENT.—Each member of the Advisory Committee appointed under paragraph (2) shall serve for a
p.001635: term of 3 years, except that the Secretary may adjust the terms of the Advisory Committee appointees
p.001635: serving on the date of enactment of the Pandemic and All-Hazards Prepared- ness and Advancing Innovation Act of 2019,
p.001635: or appointees who are initially appointed after such date of enactment, in order to provide for a
p.001635: staggered term of appointment for all mem- bers.
p.001635: (5) CONSECUTIVE APPOINTMENTS; MAXIMUM TERMS.—A member appointed under paragraph (2) may serve not
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p.001635: (b) DUTIES.—The Advisory Committee shall—
p.001635: (1) provide advice and consultation with respect to the ac- tivities carried out pursuant to section 2814, as
p.001635: applicable and appropriate;
p.001635: (2) evaluate and provide input with respect to the medical and public health needs of seniors related to
p.001635: preparation for, response to, and recovery from all-hazards emergencies; and
p.001635: (3) provide advice and consultation with respect to State emergency preparedness and response activities
p.001635: relating to seniors, including related drills and exercises pursuant to the preparedness goals under section
p.001635: 2802(b).
p.001635: (c) ADDITIONAL DUTIES.—The Advisory Committee may provide advice and recommendations to the Secretary with
p.001635: respect to sen- iors and the medical and public health grants and cooperative agreements as applicable to
p.001635: preparedness and response activities under this title and title III.
p.001635: (d) MEMBERSHIP.—
p.001635: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies as appropriate, shall appoint not more
p.001635: than 17 members to the Advisory Committee. In appointing such members, the Secretary shall ensure that the
p.001635: total mem- bership of the Advisory Committee is an odd number.
p.001635: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001635: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001635: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001635: (B) The Director of the Biomedical Advanced Research and Development Authority.
p.001635: (C) The Director of the Centers for Disease Control and Prevention.
p.001635: (D) The Commissioner of Food and Drugs.
p.001635: (E) The Director of the National Institutes of Health.
p.001635: (F) The Administrator of the Centers for Medicare & Medicaid Services.
p.001635: (G) The Administrator of the Administration for Com- munity Living.
p.001635: (H) The Administrator of the Federal Emergency Man- agement Agency.
p.001635: (I) The Under Secretary for Health of the Department of Veterans Affairs.
p.001635: (J) At least 2 non-Federal health care professionals with expertise in geriatric medical disaster
p.001635: planning, pre- paredness, response, or recovery.
p.001635: (K) At least 2 representatives of State, local, Tribal, or territorial agencies with expertise in geriatric
p.001635: disaster planning, preparedness, response, or recovery.
p.001635: (L) Representatives of such other Federal agencies (such as the Department of Energy and the Department of
p.001635: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: PUBLIC HEALTH SERVICE ACT
p.001637: Sec. 2811C
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p.001637: national advisory committee to be known as the National Advisory Committee on In- dividuals with Disabilities and
p.001637: Disasters (referred to in this section as the ‘‘Advisory Committee’’).
p.001637: (b) DUTIES.—The Advisory Committee shall—
p.001637: (1) provide advice and consultation with respect to activi- ties carried out pursuant to section 2814, as
p.001637: applicable and ap- propriate;
p.001637: (2) evaluate and provide input with respect to the medical, public health, and accessibility needs of individuals
p.001637: with dis- abilities related to preparation for, response to, and recovery from all-hazards emergencies; and
p.001637: (3) provide advice and consultation with respect to State emergency preparedness and response activities,
p.001637: including re- lated drills and exercises pursuant to the preparedness goals under section 2802(b).
p.001637: (c) MEMBERSHIP.—
p.001637: (1) IN GENERAL.—The Secretary, in consultation with such other heads of agencies and departments as appropriate, shall
p.001637: appoint not more than 17 members to the Advisory Committee. In appointing such members, the Secretary shall
p.001637: ensure that the total membership of the Advisory Committee is an odd number.
p.001637: (2) REQUIRED MEMBERS.—The Advisory Committee shall include Federal members or their designees (who may be non-
p.001637: voting members, as determined by the Secretary) and non-Fed- eral members, as follows:
p.001637: (A) The Assistant Secretary for Preparedness and Re- sponse.
p.001637: (B) The Administrator of the Administration for Com- munity Living.
p.001637: (C) The Director of the Biomedical Advanced Research and Development Authority.
p.001637: (D) The Director of the Centers for Disease Control and Prevention.
p.001637: (E) The Commissioner of Food and Drugs.
p.001637: (F) The Director of the National Institutes of Health.
p.001637: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001637: Sec. 2811D PUBLIC HEALTH SERVICE ACT 1638
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p.001637:
p.001637: (G) The Administrator of the Federal Emergency Man- agement Agency.
p.001637: (H) The Chair of the National Council on Disability.
p.001637: (I) The Chair of the United States Access Board.
p.001637: (J) The Under Secretary for Health of the Department of Veterans Affairs.
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p.001639: 1639
p.001639: PUBLIC HEALTH SERVICE ACT
p.001639: Sec. 2812
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p.001639: January 30, 2020
p.001639: (c) NOTIFICATION.—The Secretary shall annually notify the congressional committees of jurisdiction
p.001639: regarding the steps taken to coordinate, as appropriate, the recommendations under this sec- tion, and provide a
p.001639: summary description of such coordination.
p.001639: SEC. 2812. ø42 U.S.C. 300hh–11¿ NATIONAL DISASTER MEDICAL SYSTEM.
p.001639: (a) NATIONAL DISASTER MEDICAL SYSTEM.—
p.001639: (1) IN GENERAL.—The Secretary shall provide for the oper- ation in accordance with this section of a system to
p.001639: be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary
p.001639: for Preparedness and Re- sponse as the head of the National Disaster Medical System, subject to the
p.001639: authority of the Secretary.
p.001639: (2) FEDERAL AND STATE COLLABORATIVE SYSTEM.—
p.001639: (A) IN GENERAL.—The National Disaster Medical Sys- tem shall be a coordinated effort by the Federal
p.001639: agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public or
p.001639: private en- tities, to carry out the purposes described in paragraph (3).
p.001639: (B) PARTICIPATING FEDERAL AGENCIES.—The Federal agencies referred to in subparagraph (A) are the Depart-
p.001639: ment of Health and Human Services, the Department of Homeland Security, the Department of Defense, and
p.001639: the Department of Veterans Affairs.
p.001639: (3) PURPOSE OF SYSTEM.—
p.001639: (A) IN GENERAL.—The Secretary may activate the Na- tional Disaster Medical System to—
p.001639: (i) provide health services, health-related social services, other appropriate human services, and appro- priate
p.001639: auxiliary services to respond to the needs of vic- tims of a public health emergency, including at-risk
p.001639: individuals as applicable (whether or not determined to be a public health emergency under section 319); or
p.001639: (ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that
p.001639: the Secretary has determined that a location is at risk of a public health emergency during the time specified, or
p.001639: there is a significant potential for a public health emergency.
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p.001641: committees of jurisdiction a notification detailing—
p.001641: (A) the impact such shortage could have on meeting public health needs and emergency medical
p.001641: personnel needs during a public health emergency; and
p.001641: (B) any identified measures to address such shortage.
p.001641: (4) CERTAIN APPOINTMENTS.—
p.001641: (A) IN GENERAL.—If the Secretary determines that the number of intermittent disaster response personnel within the
p.001641: National Disaster Medical System under this section is insufficient to address a public health emergency or poten- tial
p.001641: public health emergency, the Secretary may appoint candidates directly to personnel positions for
p.001641: intermittent disaster response within such system. The Secretary shall provide updates on the number of vacant
p.001641: or unfilled posi- tions within such system to the congressional committees
p.001641: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001641: Sec. 2812 PUBLIC HEALTH SERVICE ACT 1642
p.001641:
p.001641: of jurisdiction each quarter for which this authority is in effect.
p.001641: (B) SUNSET.—The authority under this paragraph shall expire on September 30, 2021.
p.001641: (5) 1 SERVICE BENEFIT.—Individuals appointed to serve under this subsection shall be considered
p.001641: eligible for benefits under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968. The
p.001641: Secretary shall provide notification to any eligible individual of any effect such designation may have on other
p.001641: benefits for which such individual is eligible, includ- ing benefits from private entities.
p.001641: (d) CERTAIN EMPLOYMENT ISSUES REGARDING INTERMITTENT APPOINTMENTS.—
p.001641: (1) INTERMITTENT DISASTER-RESPONSE APPOINTEE.—For purposes of this subsection, the term ‘‘intermittent
p.001641: disaster-re- sponse appointee’’ means an individual appointed by the Sec- retary under subsection (c).
p.001641: (2) COMPENSATION FOR WORK INJURIES.—
p.001641: (A) IN GENERAL.—An intermittent disaster-response appointee shall, while acting in the scope of such appoint-
p.001641: ment, be considered to be an employee of the Public Health Service performing medical, surgical,
p.001641: dental, or re- lated functions, and an injury sustained by such an indi- vidual shall be deemed ‘‘in the
p.001641: performance of duty’’, for purposes of chapter 81 of title 5, United States Code, per- taining to compensation for
p.001641: work injuries.
p.001641: (B) APPLICATION TO TRAINING PROGRAMS.—With re- spect to the participation of individuals appointed under
p.001641: subsection (c) in training programs authorized by the As- sistant Secretary for Preparedness and Response or a
p.001641: com- parable official of any Federal agency specified in sub- section (a)(2)(B), injuries sustained by
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p.001643: (4) have registered and carry out training exercises with a local chapter of the Medical Reserve Corps; and
p.001643: (5) indicate whether they are willing to be deployed out- side the area in which they reside in the
p.001643: event of a public health emergency.
p.001643: (d) CERTIFICATION; DRILLS.—
p.001643: (1) CERTIFICATION.—The Director, in collaboration with State, local, and tribal officials, shall establish a
p.001643: process for the periodic certification of individuals who volunteer for the Corps, as determined by the
p.001643: Secretary, which shall include the completion by each individual of the core training programs de- veloped under
p.001643: section 319F, as required by the Director. Such certification shall not supercede State
p.001643: licensing or credentialing requirements.
p.001643: (2) DRILLS.—In conjunction with the core training pro- grams referred to in paragraph (1), and in order
p.001643: to facilitate the integration of trained volunteers into the health care sys- tem at the local level, Corps
p.001643: members shall engage in periodic training exercises to be carried out at the local level. Such training
p.001643: exercises shall, as appropriate and applicable, incor- porate the needs of at-risk individuals in the event of a
p.001643: public health emergency.
p.001643: (e) DEPLOYMENT.—During a public health emergency, the Sec- retary shall have the authority to activate and
p.001643: deploy willing mem- bers of the Corps to areas of need, taking into consideration the public health and
p.001643: medical expertise required, with the concurrence of the State, local, or tribal officials from the area where the mem-
p.001643: bers reside.
p.001643: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001645: 1645
p.001645: PUBLIC HEALTH SERVICE ACT
p.001645: Sec. 2814
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p.001645: (f) EXPENSES AND TRANSPORTATION.—While engaged in per- forming duties as a member of the Corps pursuant
p.001645: to an assign- ment by the Secretary (including periods of travel to facilitate such assignment), members of the
p.001645: Corps who are not otherwise em- ployed by the Federal Government shall be allowed travel or trans- portation
p.001645: expenses, including per diem in lieu of subsistence.
p.001645: (g) IDENTIFICATION.—The Secretary, in cooperation and con- sultation with the States, shall develop a
p.001645: Medical Reserve Corps Identification Card that describes the licensure and certification in- formation of Corps
p.001645: members, as well as other identifying informa- tion determined necessary by the Secretary.
p.001645: (h) INTERMITTENT DISASTER-RESPONSE PERSONNEL.—
p.001645: (1) IN GENERAL.—For the purpose of assisting the Corps in carrying out duties under this section, during a
p.001645: public health emergency, the Secretary may appoint selected individuals to serve as intermittent personnel
p.001645: of such Corps in accordance with applicable civil service laws and regulations. In all other cases,
p.001645: members of the Corps are subject to the laws of the State in which the activities of the Corps are
p.001645: undertaken.
p.001645: (2) APPLICABLE PROTECTIONS.—Subsections (c)(2), (d), and
p.001645: (e) of section 2812 shall apply to an individual appointed under paragraph (1) in the same manner as such
p.001645: subsections apply to an individual appointed under section 2812(c).
p.001645: (3) LIMITATION.—State, local, and tribal officials shall have no authority to designate a member of the Corps
p.001645: as Federal intermittent disaster-response personnel, but may request the services of such members.
p.001645: (i) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this section,
p.001645: $11,200,000 for each of fiscal years 2019 through 2023.
p.001645: SEC. 2814. ø42 U.S.C. 300hh–16¿ AT-RISK INDIVIDUALS.
p.001645: The Secretary, acting through such employee of the Depart- ment of Health and Human Services as
p.001645: determined by the Sec- retary and designated publicly (which may, at the discretion of the Secretary, involve the
p.001645: appointment or designation of an individual as the Director of At-Risk Individuals), shall—
p.001645: (1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response
p.001645: for at- risk individuals in the event of a public health emergency de- clared by the Secretary under section
p.001645: 319;
p.001645: (2) oversee the implementation of the preparedness goals described in section 2802(b) with respect to the
p.001645: public health and medical needs of at-risk individuals in the event of a pub- lic health emergency, as described in
p.001645: section 2802(b)(4);
p.001645: (3) assist other Federal agencies responsible for planning for, responding to, and recovering from public
p.001645: health emer- gencies in addressing the needs of at-risk individuals;
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p.001659: ming interfaces or successor technology or standards, as provided for under applicable law, including pro-
p.001659: viding access to all data elements of a patient’s elec- tronic health record to the extent permissible
p.001659: under applicable privacy laws;
p.001659: (v) has successfully tested the real world use of the technology for interoperability (as defined in
p.001659: sec- tion 3000) in the type of setting in which such tech- nology would be marketed;
p.001659: (vi) provides to the Secretary an attestation that the developer or entity—
p.001659: (I) has not engaged in any of the conduct de- scribed in clause (i);
p.001659: (II) has provided assurances satisfactory to the Secretary in accordance with clause (ii);
p.001659: (III) does not prohibit or restrict communica- tion as described in clause (iii);
p.001659: (IV) has published information in accordance with clause (iv);
p.001659: (V) ensures that its technology allows for health information to be exchanged, accessed, and used, in the
p.001659: manner described in clause (iv); and
p.001659: (VI) has undertaken real world testing as de- scribed in clause (v); and
p.001659: (vii) submits reporting criteria in accordance with section 3009A(b).
p.001659: (E) COMPLIANCE WITH CONDITIONS OF CERTIFI- CATION.—The Secretary may encourage compliance
p.001659: with the conditions of certification described in subparagraph
p.001659: (D) and take action to discourage noncompliance, as appro- priate.
p.001659: (6) REPORTS AND PUBLICATIONS.—
p.001659: (A) REPORT ON ADDITIONAL FUNDING OR AUTHORITY NEEDED.—Not later than 12 months after the date of
p.001659: the enactment of this title, the National Coordinator shall sub- mit to the appropriate committees of
p.001659: jurisdiction of the
p.001659: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001659: Sec. 3001 PUBLIC HEALTH SERVICE ACT 1660
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p.001659: January 30, 2020
p.001659:
p.001659: House of Representatives and the Senate a report on any additional funding or authority the Coordinator or the
p.001659: HIT Advisory Committee requires to evaluate and develop standards, implementation specifications, and
p.001659: certification criteria, or to achieve full participation of stakeholders in the adoption of a nationwide health
p.001659: information technology infrastructure that allows for the electronic use and ex- change of health information.
p.001659: (B) IMPLEMENTATION REPORT.—The National Coordi- nator shall prepare a report that identifies lessons learned from
p.001659: major public and private health care systems in their implementation of health information technology, includ- ing
p.001659: information on whether the technologies and practices developed by such systems may be applicable to and usa-
p.001659: ble in whole or in part by other health care providers.
p.001659: (C) ASSESSMENT OF IMPACT OF HIT ON COMMUNITIES WITH HEALTH DISPARITIES AND UNINSURED, UNDERINSURED,
p.001659: AND MEDICALLY UNDERSERVED AREAS.—The National Coor- dinator shall assess and publish the impact of health infor-
p.001659: mation technology in communities with health disparities and in areas with a high proportion of individuals who
p.001659: are uninsured, underinsured, and medically underserved indi- viduals (including urban and rural areas) and
p.001659: identify practices to increase the adoption of such technology by health care providers in such communities,
p.001659: and the use of health information technology to reduce and better man- age chronic diseases.
p.001659: (D) EVALUATION OF BENEFITS AND COSTS OF THE ELEC- TRONIC USE AND EXCHANGE OF HEALTH INFORMATION.—The
p.001659: National Coordinator shall evaluate and publish evidence on the benefits and costs of the electronic use
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p.001665: medical errors, improving population health, reducing chronic disease, and advancing research and education.
p.001665: (ii) The use of technologies that address the needs of children and other vulnerable populations.
p.001665: (iii) The use of electronic systems to ensure the comprehensive collection of patient demographic data,
p.001665: including at a minimum, race, ethnicity, primary lan- guage, and gender information.
p.001665: (iv) The use of self-service, telemedicine, home health care, and remote monitoring technologies.
p.001665: (v) The use of technologies that meet the needs of diverse populations.
p.001665: (vi) The use of technologies that support—
p.001665: (I) data for use in quality and public reporting programs;
p.001665: (II) public health; or
p.001665: (III) drug safety.
p.001665: (vii) The use of technologies that allow individ- ually identifiable health information to be rendered
p.001665: unusable, unreadable, or indecipherable to unauthor- ized individuals when such information is transmitted in a
p.001665: health information network or transported outside of the secure facilities or systems where the disclosing covered
p.001665: entity is responsible for security conditions.
p.001665: (viii) The use of a certified health information technology for each individual in the United States.
p.001665: (D) AUTHORITY FOR TEMPORARY ADDITIONAL PRIORITY TARGET AREAS.—For purposes of subparagraph (B)(iv), the
p.001665: HIT Advisory Committee may identify an area to be con- sidered for purposes of recommendations under
p.001665: this sub- section as a target area described in subparagraph (B) if—
p.001665: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001665: Sec. 3002 PUBLIC HEALTH SERVICE ACT 1666
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p.001665: January 30, 2020
p.001665:
p.001665: (i) the area is so identified for purposes of re- sponding to new circumstances that have arisen in the health
p.001665: information technology community that affect the interoperability, privacy, or security of health in-
p.001665: formation, or affect patient safety; and
p.001665: (ii) at least 30 days prior to treating such area as if it were a target area described in subparagraph (B), the
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p.001671: this title through the process existing through the Office of the National Coordinator for Health Information
p.001671: Technology may be applied towards meeting the requirement of paragraph (1).
p.001671: (3) SUBSEQUENT STANDARDS ACTIVITY.—The Secretary shall adopt additional standards, implementation specifications, and
p.001671: certification criteria as necessary and consistent with the schedule published under section 3002(b)(4).
p.001671: (c) DEFERENCE TO STANDARDS DEVELOPMENT ORGANIZA- TIONS.—In adopting and implementing standards
p.001671: under this sec- tion, the Secretary shall give deference to standards published by standards development
p.001671: organizations and voluntary consensus- based standards bodies.
p.001671: SEC. 3005. ø300jj–15¿ APPLICATION AND USE OF ADOPTED STANDARDS AND IMPLEMENTATION SPECIFICATIONS BY FEDERAL
p.001671: AGENCIES.
p.001671: For requirements relating to the application and use by Fed- eral agencies of the standards and
p.001671: implementation specifications adopted under section 3004, see section 13111 of the Health Infor- mation Technology for
p.001671: Economic and Clinical Health Act.
p.001671: SEC. 3006. ø300jj–16¿ VOLUNTARY APPLICATION AND USE OF ADOPTED STANDARDS AND IMPLEMENTATION SPECIFICATIONS BY
p.001671: PRIVATE ENTITIES.
p.001671: (a) IN GENERAL.—Except as provided under section 13112 of the HITECH Act, nothing in such Act or in the
p.001671: amendments made by such Act shall be construed—
p.001671: (1) to require a private entity to adopt or comply with a standard or implementation specification
p.001671: adopted under sec- tion 3004; or
p.001671: (2) to provide a Federal agency authority, other than the authority such agency may have under other
p.001671: provisions of law, to require a private entity to comply with such a standard or implementation
p.001671: specification.
p.001671: (b) RULE OF CONSTRUCTION.—Nothing in this subtitle shall be construed to require that a private entity
p.001671: that enters into a con- tract with the Federal Government apply or use the standards and implementation
p.001671: specifications adopted under section 3004 with re- spect to activities not related to the contract.
p.001671: SEC. 3007. ø300jj–17¿ FEDERAL HEALTH INFORMATION TECHNOLOGY.
p.001671: (a) IN GENERAL.—The National Coordinator shall support the development and routine updating of qualified
p.001671: electronic health record technology (as defined in section 3000) consistent with sub-
p.001671: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001673: PUBLIC HEALTH SERVICE ACT
p.001673: Sec. 3009
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p.001673: security law.
p.001673: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001673: Sec. 3009 PUBLIC HEALTH SERVICE ACT 1674
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p.001673: January 30, 2020
p.001673:
p.001673: (2) DEFINITION.—For purposes of this section, the term ‘‘HIPAA privacy and security law’’ means—
p.001673: (A) the provisions of part C of title XI of the Social Se- curity Act, section 264 of the Health Insurance Portability
p.001673: and Accountability Act of 1996, and subtitle D of title IV of the Health Information Technology for
p.001673: Economic and Clinical Health Act; and
p.001673: (B) regulations under such provisions.
p.001673: (b) FLEXIBILITY.—In administering the provisions of this title, the Secretary shall have flexibility in
p.001673: applying the definition of health care provider under section 3000(3), including the authority to omit certain
p.001673: entities listed in such definition when applying such definition under this title, where appropriate.
p.001673: (c) PROMOTING PATIENT ACCESS TO ELECTRONIC HEALTH IN-
p.001673: FORMATION THROUGH HEALTH INFORMATION EXCHANGES.—
p.001673: (1) IN GENERAL.—The Secretary shall use existing authori- ties to encourage partnerships between health
p.001673: information ex- change organizations and networks and health care providers, health plans, and other
p.001673: appropriate entities with the goal of of- fering patients access to their electronic health information in a
p.001673: single, longitudinal format that is easy to understand, se- cure, and may be updated automatically.
p.001673: (2) EDUCATION OF PROVIDERS.—The Secretary, in coordina- tion with the Office for Civil Rights of the
p.001673: Department of Health and Human Services, shall—
p.001673: (A) educate health care providers on ways of leveraging the capabilities of health information
p.001673: exchanges (or other relevant platforms) to provide patients with ac- cess to their electronic health
p.001673: information;
p.001673: (B) clarify misunderstandings by health care providers about using health information exchanges (or other rel-
p.001673: evant platforms) for patient access to electronic health in- formation; and
p.001673: (C) to the extent practicable, educate providers about health information exchanges (or other relevant
p.001673: platforms) that employ some or all of the capabilities described in paragraph (1).
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p.001685:
p.001685: Sec. 3014 PUBLIC HEALTH SERVICE ACT 1686
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p.001685: mination of the Secretary, will lead towards the greatest improve- ment in quality of care, decrease in
p.001685: costs, and the most effective authorized and secure electronic exchange of health information.
p.001685: (i) REQUIRED MATCH.—
p.001685: (1) IN GENERAL.—For a fiscal year (beginning with fiscal year 2011), the Secretary may not make a grant
p.001685: under this section to a State unless the State agrees to make available non-Federal contributions (which
p.001685: may include in-kind contribu- tions) toward the costs of a grant awarded under subsection (c) in an amount equal to—
p.001685: (A) for fiscal year 2011, not less than $1 for each $10 of Federal funds provided under the grant;
p.001685: (B) for fiscal year 2012, not less than $1 for each $7 of Federal funds provided under the grant; and
p.001685: (C) for fiscal year 2013 and each subsequent fiscal year, not less than $1 for each $3 of Federal
p.001685: funds pro- vided under the grant.
p.001685: (2) AUTHORITY TO REQUIRE STATE MATCH FOR FISCAL YEARS BEFORE FISCAL YEAR 2011.—For any fiscal year during the
p.001685: grant program under this section before fiscal year 2011, the Sec- retary may determine the extent to
p.001685: which there shall be re- quired a non-Federal contribution from a State receiving a grant under this
p.001685: section.
p.001685: SEC. 3014. ø300jj–34¿ COMPETITIVE GRANTS TO STATES AND INDIAN TRIBES FOR THE DEVELOPMENT OF LOAN PROGRAMS TO
p.001685: FACILITATE THE WIDESPREAD ADOPTION OF CERTIFIED EHR TECHNOLOGY.
p.001685: (a) IN GENERAL.—The National Coordinator may award com- petitive grants to eligible entities for the
p.001685: establishment of programs for loans to health care providers to conduct the activities described in subsection (e).
p.001685: (b) ELIGIBLE ENTITY DEFINED.—For purposes of this sub- section, the term ‘‘eligible entity’’ means a
p.001685: State or Indian tribe (as defined in the Indian Self-Determination and Education Assistance Act) that—
p.001685: (1) submits to the National Coordinator an application at such time, in such manner, and containing such
p.001685: information as the National Coordinator may require;
p.001685: (2) submits to the National Coordinator a strategic plan in accordance with subsection (d) and provides to the
p.001685: National Coordinator assurances that the entity will update such plan annually in accordance with such
p.001685: subsection;
p.001685: (3) provides assurances to the National Coordinator that the entity will establish a Loan Fund in
p.001685: accordance with sub- section (c);
p.001685: (4) provides assurances to the National Coordinator that the entity will not provide a loan from the
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p.001693: (ii) lead to fraud, waste, or abuse, or impede inno- vations and advancements in health information ac- cess,
p.001693: exchange, and use, including care delivery en- abled by health information technology.
p.001693: (3) RULEMAKING.—The Secretary, through rulemaking, shall identify reasonable and necessary activities
p.001693: that do not constitute information blocking for purposes of paragraph (1).
p.001693: (4) NO ENFORCEMENT BEFORE EXCEPTION IDENTIFIED.—The term ‘‘information blocking’’ does not include any
p.001693: practice or conduct occurring prior to the date that is 30 days after the date of enactment of the 21st
p.001693: Century Cures Act.
p.001693: (5) CONSULTATION.—The Secretary may consult with the Federal Trade Commission in promulgating regulations
p.001693: under this subsection, to the extent that such regulations define prac- tices that are necessary to promote
p.001693: competition and consumer welfare.
p.001693: (6) APPLICATION.—The term ‘‘information blocking’’, with respect to an individual or entity, shall not
p.001693: include an act or practice other than an act or practice committed by such indi- vidual or entity.
p.001693: (7) CLARIFICATION.—In carrying out this section, the Sec- retary shall ensure that health care providers
p.001693: are not penal- ized for the failure of developers of health information tech- nology or other entities
p.001693: offering health information technology to such providers to ensure that such technology meets the re- quirements to
p.001693: be certified under this title.
p.001693: (b) INSPECTOR GENERAL AUTHORITY.—
p.001693: (1) IN GENERAL.—The inspector general of the Department of Health and Human Services (referred to in this
p.001693: section as the ‘‘Inspector General’’) may investigate any claim that—
p.001693: (A) a health information technology developer of cer- tified health information technology or other entity
p.001693: offer- ing certified health information technology—
p.001693: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001695: PUBLIC HEALTH SERVICE ACT
p.001695: Sec. 3022
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p.001695: (i) submitted a false attestation under section 3001(c)(5)(D)(vii); or
p.001695: (ii) engaged in information blocking;
p.001695: (B) a health care provider engaged in information blocking; or
p.001695: (C) a health information exchange or network engaged in information blocking.
p.001695: (2) PENALTIES.—
p.001695: (A) DEVELOPERS, NETWORKS, AND EXCHANGES.—Any individual or entity described in subparagraph (A) or (C)
p.001695: of paragraph (1) that the Inspector General, following an investigation conducted under this subsection,
p.001695: determines to have committed information blocking shall be subject to a civil monetary penalty determined by the
p.001695: Secretary for all such violations identified through such investigation, which may not exceed $1,000,000
p.001695: per violation. Such de- termination shall take into account factors such as the na- ture and extent of the
p.001695: information blocking and harm re- sulting from such information blocking, including, where applicable, the
p.001695: number of patients affected, the number of providers affected, and the number of days the information blocking
p.001695: persisted.
p.001695: (B) PROVIDERS.—Any individual or entity described in subparagraph (B) of paragraph (1) determined by the
p.001695: In- spector General to have committed information blocking shall be referred to the appropriate agency to be
p.001695: subject to appropriate disincentives using authorities under applica- ble Federal law, as the Secretary sets forth
p.001695: through notice and comment rulemaking.
p.001695: (C) PROCEDURE.—The provisions of section 1128A of the Social Security Act (other than subsections (a) and (b) of
p.001695: such section) shall apply to a civil money penalty ap- plied under this paragraph in the same manner
p.001695: as such provisions apply to a civil money penalty or proceeding under such section 1128A(a).
p.001695: (D) RECOVERED PENALTY FUNDS.—The amounts recov- ered under this paragraph shall be allocated as follows:
p.001695: (i) ANNUAL OPERATING EXPENSES.—Each year fol- lowing the establishment of the authority under this
p.001695: subsection, the Office of the Inspector General shall provide to the Secretary an estimate of the costs
p.001695: to carry out investigations under this section. Such esti- mate may include reasonable reserves to account
p.001695: for variance in annual amounts recovered under this paragraph. There is authorized to be
p.001695: appropriated for purposes of carrying out this section an amount equal to the amount specified in such estimate for
p.001695: the fiscal year.
p.001695: (ii) APPLICATION TO OTHER PROGRAMS.—The amounts recovered under this paragraph and remain- ing
p.001695: after amounts are made available under clause (i) shall be transferred to the Federal Hospital Insurance Trust Fund
p.001695: under section 1817 of the Social Security Act and the Federal Supplementary Medical Insurance
p.001695: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001707: under section 3002(b); and
p.001707: (vi) for meeting periodically with the cor- responding Clinical Centers of Excellence to obtain
p.001707: input on the analysis and reporting of data collected under clause (i) and on the development of monitoring,
p.001707: initial health evaluation, and treatment protocols under clause (ii).
p.001707: (B) MEDICAL PROVIDER SELECTION.—The medical pro- viders under subparagraph (A)(iv) shall be selected by the WTC
p.001707: Program Administrator on the basis of their experi- ence treating or diagnosing the health conditions included
p.001707: in the list of WTC-related health conditions.
p.001707: (C) CLINICAL DISCUSSIONS.—In carrying out subpara- graph (A)(ii), a Data Center shall engage in clinical discus-
p.001707: sions across the WTC Program to guide treatment ap- proaches for individuals with a WTC-related health condi-
p.001707: tion.
p.001707: (D) TRANSPARENCY OF DATA.—A contract entered into under this subsection with a Data Center shall require the Data
p.001707: Center to make any data collected and reported to such Center under subsection (b)(1)(B)(iii)
p.001707: available to health researchers and others as provided in the CDC/ ATSDR Policy on Releasing and Sharing
p.001707: Data.
p.001707: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001707:
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p.001707:
p.001707:
p.001709: 1709
p.001709: PUBLIC HEALTH SERVICE ACT
p.001709: Sec. 3305
p.001709:
p.001709: (3) AUTHORITY FOR CONTRACTS TO BE CLASS SPECIFIC.—A contract entered into under this subsection with a
p.001709: Clinical Center of Excellence or a Data Center may be with respect to one or more class of enrolled WTC
p.001709: responders, screening-eligi- ble WTC survivors, or certified-eligible WTC survivors.
p.001709: (4) USE OF COOPERATIVE AGREEMENTS.—Any contract under this title between the WTC Program Administrator and
p.001709: a Data Center or a Clinical Center of Excellence may be in the form of a cooperative agreement.
p.001709: (5) REVIEW ON FEASIBILITY OF CONSOLIDATING DATA CEN- TERS.—Not later than July 1, 2011, the Comptroller General
p.001709: of the United States shall submit to the Committee on Energy and Commerce of the House of
p.001709: Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Sen- ate a report
p.001709: on the feasibility of consolidating Data Centers into a single Data Center.
p.001709: (b) CENTERS OF EXCELLENCE.—
p.001709: (1) CLINICAL CENTERS OF EXCELLENCE.—
p.001709: (A) DEFINITION.—For purposes of this title, the term ‘‘Clinical Center of Excellence’’ means a Center
p.001709: that dem- onstrates to the satisfaction of the Administrator that the Center—
p.001709: (i) uses an integrated, centralized health care pro- vider approach to create a comprehensive suite of
p.001709: health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC sur-
p.001709: vivors, or certified-eligible WTC survivors;
p.001709: (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes
...

p.001713: World Trade Center sites (including Ground Zero, Staten Is- land Landfill, and the New York City Chief
p.001713: Medical Examiner’s Office) for any time during the period be- ginning on September 11, 2001, and ending
p.001713: on July 31, 2002; or
p.001713: (ii)(I) is a surviving immediate family member of an individual who was a member of the Fire Depart-
p.001713: ment of New York City (whether fire or emergency personnel, active or retired) and was killed at the
p.001713: World Trade site on September 11, 2001; and
p.001713: (II) received any treatment for a WTC-related health condition described in section 3312(a)(1)(A)(ii)
p.001713: (relating to mental health conditions) on or before Sep- tember 1, 2008.
p.001713: (B) LAW ENFORCEMENT OFFICERS AND WTC RESCUE, RE- COVERY, AND CLEANUP WORKERS.—The individual—
p.001713: (i) worked or volunteered onsite in rescue, recov- ery, debris cleanup, or related support services
p.001713: in lower Manhattan (south of Canal St.), the Staten Is- land Landfill, or the barge loading piers, for
p.001713: at least 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001, for at
p.001713: least
p.001713: 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, or for at least
p.001713: 80 hours during the period beginning on Sep- tember 11, 2001, and ending on July 31, 2002;
p.001713: (ii)(I) was a member of the Police Department of New York City (whether active or retired) or a mem-
p.001713: ber of the Port Authority Police of the Port Authority of New York and New Jersey (whether active or
p.001713: re- tired) who participated onsite in rescue, recovery, de- bris cleanup, or related services in lower
p.001713: Manhattan (south of Canal St.), including Ground Zero, the Stat- en Island Landfill, or the barge loading
p.001713: piers, for at least 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001;
p.001713: (II) participated onsite in rescue, recovery, debris cleanup, or related services at Ground Zero, the Staten
p.001713: Island Landfill, or the barge loading piers, for at least one day during the period beginning on September 11, 2001,
p.001713: and ending on July 31, 2002;
p.001713: (III) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal
p.001713: St.) for at least 24 hours during the period
p.001713: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001713:
p.001715: 1715
p.001715: PUBLIC HEALTH SERVICE ACT
p.001715: Sec. 3311
p.001715:
p.001715: beginning on September 11, 2001, and ending on Sep- tember 30, 2001; or
p.001715: (IV) participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal
p.001715: St.) for at least 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002;
p.001715: (iii) was an employee of the Office of the Chief Medical Examiner of New York City involved in the
p.001715: examination and handling of human remains from the World Trade Center attacks, or other morgue worker who
p.001715: performed similar post-September 11 functions for such Office staff, during the period beginning on
p.001715: September 11, 2001, and ending on July 31, 2002;
p.001715: (iv) was a worker in the Port Authority Trans- Hudson Corporation Tunnel for at least 24 hours dur- ing the
p.001715: period beginning on February 1, 2002, and ending on July 1, 2002; or
p.001715: (v) was a vehicle-maintenance worker who was ex- posed to debris from the former World Trade Center while
p.001715: retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from
p.001715: the September 11, 2001, terrorist attacks during a duration and period described in subparagraph (A).
p.001715: (C) RESPONDERS TO THE SEPTEMBER 11 ATTACKS AT THE PENTAGON AND SHANKSVILLE, PENNSYLVANIA.—The indi-
p.001715: vidual—
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p.001715: January 30, 2020
p.001715: (i)(I) was a member of a fire or police department (whether fire or emergency personnel, active or re- tired),
p.001715: worked for a recovery or cleanup contractor, or was a volunteer; and performed rescue, recovery, dem- olition,
p.001715: debris cleanup, or other related services at the Pentagon site of the terrorist-related aircraft crash of
p.001715: September 11, 2001, during the period beginning on September 11, 2001, and ending on the date on which the
p.001715: cleanup of the site was concluded, as determined by the WTC Program Administrator; or
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General/Other / cultural difference

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p.000131: January 30, 2020
p.000131: (c) COORDINATING ACTIVITIES.—To carry out this section, the Secretary may—
p.000131: (1) provide technical and consultative assistance to entities receiving grants under subsection (b);
p.000131: (2) ensure a pathway for data sharing between States, tribal entities, and the Centers for Disease
p.000131: Control and Pre- vention;
p.000131: (3) ensure data collection under this section is consistent with applicable State, Federal, and Tribal privacy
p.000131: laws; and
p.000131: (4) coordinate with the National Coordinator for Health In- formation Technology, as appropriate, to assist
p.000131: States and Tribes in implementing systems that use standards recognized by such National Coordinator, as such
p.000131: recognized standards are available, in order to facilitate interoperability between such systems and health
p.000131: information technology systems, in- cluding certified health information technology.
p.000131: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000131: to be appropriated such sums as may be necessary for each of the fiscal years 2019 through 2023.
p.000131: SEC. 317L–1. ø247b–13a¿ SCREENING AND TREATMENT FOR MATERNAL DEPRESSION.
p.000131: (a) GRANTS.—The Secretary shall make grants to States to es- tablish, improve, or maintain programs for
p.000131: screening, assessment, and treatment services, including culturally and linguistically ap- propriate services,
p.000131: as appropriate, for women who are pregnant, or who have given birth within the preceding 12 months, for maternal
p.000131: depression.
p.000131: (b) APPLICATION.—To seek a grant under this section, a State shall submit an application to the
p.000131: Secretary at such time, in such manner, and containing such information as the Secretary may re- quire. At a
p.000131: minimum, any such application shall include expla- nations of—
p.000131: (1) how a program, or programs, will increase the percent- age of women screened and treated, as appropriate, for
p.000131: mater- nal depression in 1 or more communities; and
p.000131: (2) how a program, or programs, if expanded, would in- crease access to screening and treatment services for
p.000131: maternal depression.
p.000131: (c) PRIORITY.—In awarding grants under this section, the Sec- retary may give priority to States proposing to
p.000131: improve or enhance access to screening services for maternal depression in primary care settings.
p.000131: (d) USE OF FUNDS.—The activities eligible for funding through a grant under subsection (a)—
p.000131: (1) shall include—
p.000131: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000353: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000353: Sec. 340 PUBLIC HEALTH SERVICE ACT 354
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p.000353: January 30, 2020
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p.000353: (F) demonstrates that the applicant makes use of non-
p.000353: Federal contributions to the greatest extent possible; or
p.000353: (G) demonstrates a likelihood that the proposed pro- gram will continue after support under this section ceases.
p.000353: (e) USE OF FUNDS.—
p.000353: (1) USE BY GRANTEES.—
p.000353: (A) IN GENERAL.—Except as provided in paragraphs
p.000353: (2) and (3), a grantee may use amounts provided under this section only for—
p.000353: (i) direct expenses associated with achieving the greater integration of a health care delivery system so that
p.000353: the system either directly provides or ensures the provision of a broad range of culturally competent services,
p.000353: as appropriate, including primary, secondary, and tertiary services, as well as substance abuse treat- ment and mental
p.000353: health services; and
p.000353: (ii) direct patient care and service expansions to fill identified or documented gaps within an integrated
p.000353: delivery system.
p.000353: (B) SPECIFIC USES.—The following are examples of purposes for which a grantee may use grant funds under
p.000353: this section, when such use meets the conditions stated in subparagraph (A):
p.000353: (i) Increases in outreach activities and closing gaps in health care service.
p.000353: (ii) Improvements to case management.
p.000353: (iii) Improvements to coordination of transpor- tation to health care facilities.
p.000353: (iv) Development of provider networks and other innovative models to engage physicians in voluntary efforts
p.000353: to serve the medically underserved within a community.
p.000353: (v) Recruitment, training, and compensation of necessary personnel.
p.000353: (vi) Acquisition of technology for the purpose of co- ordinating care.
p.000353: (vii) Improvements to provider communication, in- cluding implementation of shared information systems or shared
p.000353: clinical systems.
p.000353: (viii) Development of common processes for deter- mining eligibility for the programs provided through the
p.000353: system, including creating common identification cards and single sliding scale discounts.
p.000353: (ix) Development of specific prevention and dis- ease management tools and processes.
p.000353: (x) Translation services.
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p.000539: (3) the development or enhancement and implementation of comprehensive statewide strategies to improve the
p.000539: response of clinics, public health facilities, hospitals, and other health settings (including behavioral
p.000539: and mental health programs) to domestic violence, dating violence, sexual assault, and stalking.
p.000539: (b) USE OF FUNDS.—
p.000539: (1) REQUIRED USES.—Amounts provided under a grant under this section shall be used to—
p.000539: (A) fund interdisciplinary training and education pro- grams under paragraphs (1) and (2) of
p.000539: subsection (a) that—
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p.000539: January 30, 2020
p.000539: (i) are designed to train medical, psychology, den- tal, social work, nursing, and other health profession
p.000539: students, interns, residents, fellows, or current health care providers to identify and provide health care serv-
p.000539: ices (including mental or behavioral health care serv- ices and referrals to appropriate community
p.000539: services) to individuals who are or who have been victims of do- mestic violence, dating violence, sexual
p.000539: assault, or stalking; and
p.000539: (ii) plan and develop culturally competent clinical training components for integration into approved in-
p.000539: ternship, residency, and fellowship training or con- tinuing medical or other health education training
p.000539: that address physical, mental, and behavioral health issues, including protective factors, related to domestic
p.000539: violence, dating violence, sexual assault, stalking, and other forms of violence and abuse, focus on reducing
p.000539: health disparities and preventing violence and abuse, and include the primacy of victim safety and confiden-
p.000539: tiality;
p.000539: (B) design and implement comprehensive strategies to improve the response of the health care system to domestic or
p.000539: sexual violence in clinical and public health settings, hospitals, clinics, and other health settings
p.000539: (including be- havioral and mental health), under subsection (a)(3) through—
p.000539: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000539: Sec. 399P PUBLIC HEALTH SERVICE ACT 540
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p.000553: 553
p.000553: PUBLIC HEALTH SERVICE ACT
p.000553: Sec. 399U
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p.000553: January 30, 2020
p.000553: (c) PROVISION OF INFORMATION TO PROVIDERS.—
p.000553: (1) IN GENERAL.—A grantee under this section shall make available to health care providers of parents who receive a
p.000553: pre- natal or postnatal diagnosis the following:
p.000553: (A) Up-to-date, evidence-based, written information concerning the range of outcomes for individuals
p.000553: living with the diagnosed condition, including physical, develop- mental, educational, and psychosocial outcomes.
p.000553: (B) Contact information regarding support services, in- cluding information hotlines specific to Down syndrome or other
p.000553: prenatally or postnatally diagnosed conditions, re- source centers or clearinghouses, national and local
p.000553: peer support groups, and other education and support programs as described in subsection (b)(2).
p.000553: (2) INFORMATIONAL REQUIREMENTS.—Information provided under this subsection shall be—
p.000553: (A) culturally and linguistically appropriate as needed by women receiving a positive prenatal diagnosis or the
p.000553: family of infants receiving a postnatal diagnosis; and
p.000553: (B) approved by the Secretary.
p.000553: (d) REPORT.—Not later than 2 years after the date of enact- ment of this section, the Government
p.000553: Accountability Office shall submit a report to Congress concerning the effectiveness of current healthcare and
p.000553: family support programs serving as resources for the families of children with disabilities.
p.000553: SEC. 399U. ø280g–10¿ COMMUNITY PREVENTIVE SERVICES TASK FORCE.
p.000553: (a) ESTABLISHMENT AND PURPOSE.—The Director of the Cen- ters for Disease Control and Prevention shall
p.000553: convene an inde- pendent Community Preventive Services Task Force (referred to in this subsection as the ‘‘Task
p.000553: Force’’) to be composed of individuals with appropriate expertise. Such Task Force shall review the sci-
p.000553: entific evidence related to the effectiveness, appropriateness, and cost-effectiveness of community
p.000553: preventive interventions for the purpose of developing recommendations, to be published in the Guide to
p.000553: Community Preventive Services (referred to in this sec- tion as the ‘‘Guide’’), for individuals and
p.000553: organizations delivering population-based services, including primary care professionals, health care
p.000553: systems, professional societies, employers, community organizations, non-profit organizations, schools,
...

p.000555: programs under the grant.
p.000555: (j) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated, such sums as may be
p.000555: necessary to carry out this section for each of fiscal years 2010 through 2014.
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000555:
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p.000555: Sec. 399V–1 PUBLIC HEALTH SERVICE ACT 556
p.000555: (k) DEFINITIONS.—In this section:
p.000555: (1) COMMUNITY HEALTH WORKER.—The term ‘‘community health worker’’ means an individual who promotes health
p.000555: or nutrition within the community in which the individual re- sides—
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p.000555: January 30, 2020
p.000555: (A) by serving as a liaison between communities and healthcare agencies;
p.000555: (B) by providing guidance and social assistance to community residents;
p.000555: (C) by enhancing community residents’ ability to effec- tively communicate with healthcare providers;
p.000555: (D) by providing culturally and linguistically appro- priate health or nutrition education;
p.000555: (E) by advocating for individual and community health;
p.000555: (F) by providing referral and follow-up services or oth- erwise coordinating care; and
p.000555: (G) by proactively identifying and enrolling eligible in- dividuals in Federal, State, local, private or
p.000555: nonprofit health and human services programs.
p.000555: (2) COMMUNITY SETTING.—The term ‘‘community setting’’ means a home or a community organization located in
p.000555: the neighborhood in which a participant in the program under this section resides.
p.000555: (3) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private entity (including a
p.000555: State or public subdivision of a State, a public health department, a free health clinic, a hospital, or
p.000555: a Federally-qualified health center (as defined in section 1861(aa) of the Social Security Act)), or a
p.000555: consortium of any such entities.
p.000555: (4) MEDICALLY UNDERSERVED COMMUNITY.—The term ‘‘medically underserved community’’ means a community
p.000555: iden- tified by a State—
p.000555: (A) that has a substantial number of individuals who are members of a medically underserved population, as de-
p.000555: fined by section 330(b)(3); and
p.000555: (B) a significant portion of which is a health profes- sional shortage area as designated under section 332.
p.000555: SEC. 399V–1. ø280g–12¿ PRIMARY CARE EXTENSION PROGRAM.
p.000555: (a) ESTABLISHMENT, PURPOSE AND DEFINITION.—
p.000555: (1) IN GENERAL.—The Secretary, acting through the Direc- tor of the Agency for Healthcare Research and Quality,
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p.000555: tors (referred to in this section as ‘‘Health Extension Agents’’).
p.000555: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000557: PUBLIC HEALTH SERVICE ACT
p.000557: Sec. 399V–1
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p.000557: (3) DEFINITIONS.—In this section:
p.000557: (A) HEALTH EXTENSION AGENT.—The term ‘‘Health Ex- tension Agent’’ means any local, community-based health worker
p.000557: who facilitates and provides assistance to primary care practices by implementing quality improvement or
p.000557: system redesign, incorporating the principles of the pa- tient-centered medical home to provide high-quality,
p.000557: effec- tive, efficient, and safe primary care and to provide guid- ance to patients in culturally and
p.000557: linguistically appropriate ways, and linking practices to diverse health system re- sources.
p.000557: (B) PRIMARY CARE PROVIDER.—The term ‘‘primary care provider’’ means a clinician who provides integrated, acces- sible
p.000557: health care services and who is accountable for ad- dressing a large majority of personal health care needs,
p.000557: in- cluding providing preventive and health promotion serv- ices for men, women, and children of all
p.000557: ages, developing a sustained partnership with patients, and practicing in the context of family and
p.000557: community, as recognized by a State licensing or regulatory authority, unless otherwise specified in this
p.000557: section.
p.000557: (b) GRANTS TO ESTABLISH STATE HUBS AND LOCAL PRIMARY CARE EXTENSION AGENCIES.—
p.000557: (1) GRANTS.—The Secretary shall award competitive grants to States for the establishment of
p.000557: State- or multistate- level primary care Primary Care Extension Program State Hubs (referred to in this
p.000557: section as ‘‘Hubs’’).
p.000557: (2) COMPOSITION OF HUBS.—A Hub established by a State pursuant to paragraph (1)—
p.000557: (A) shall consist of, at a minimum, the State health department, the entity responsible for administering
p.000557: the State Medicaid program (if other than the State health de- partment), the State-level entity administering
p.000557: the Medi- care program, and the departments that train providers in primary care in 1 or more health professions
p.000557: schools in the State; and
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p.000575: SBHC fund- ed under this section to an individual without the consent of the parent or guardian of such
p.000575: individual if such individual is consid- ered a minor under applicable State law.
p.000575: (l) AUTHORIZATION OF APPROPRIATIONS.—For purposes of car- rying out this section, there are authorized to be
p.000575: appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014.
p.000575: SEC. 399Z–2. ø280h–6¿ INFANT AND EARLY CHILDHOOD MENTAL HEALTH PROMOTION, INTERVENTION, AND TREATMENT.
p.000575: (a) GRANTS.—The Secretary shall—
p.000575: (1) award grants to eligible entities to develop, maintain, or enhance infant and early childhood
p.000575: mental health pro- motion, intervention, and treatment programs, including—
p.000575: (A) programs for infants and children at significant risk of developing, showing early signs of, or
p.000575: having been diagnosed with mental illness, including a serious emo- tional disturbance; and
p.000575: (B) multigenerational therapy and other services that support the caregiving relationship; and
p.000575: (2) ensure that programs funded through grants under this section are evidence-informed or evidence-based models,
p.000575: prac- tices, and methods that are, as appropriate, culturally and lin-
p.000575: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000575: Sec. 399Z–2 PUBLIC HEALTH SERVICE ACT 576
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p.000575:
p.000575: guistically appropriate, and can be replicated in other appro- priate settings.
p.000575: (b) ELIGIBLE CHILDREN AND ENTITIES.—In this section:
p.000575: (1) ELIGIBLE CHILD.—The term ‘‘eligible child’’ means a child from birth to not more than 12 years of age who—
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p.000579: Northern Mariana Islands, the Virgin Islands, and the Trust Territory of the Pacific Islands.
p.000579: (e) SUNSET.—This section shall not apply after September 30, 2024.
p.000579: SEC. 399BB. ø280i–1¿ AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION.
p.000579: (a) PURPOSE.—It is the purpose of this section—
p.000579: (1) to increase awareness, reduce barriers to screening and diagnosis, promote evidence-based interventions for
p.000579: individuals with autism spectrum disorder and other developmental dis- abilities, and train professionals to
p.000579: utilize valid and reliable screening tools to diagnose or rule out and provide evidence- based
p.000579: interventions for individuals with autism spectrum dis- order and other developmental disabilities across
p.000579: their life- span; and
p.000579: (2) to conduct activities under this section with a focus on an interdisciplinary approach (as defined in
p.000579: programs devel- oped under section 501(a)(2) of the Social Security Act) that will also focus on specific
p.000579: issues for children who are not re- ceiving an early diagnosis and subsequent interventions.
p.000579: (b) IN GENERAL.—The Secretary shall, subject to the avail- ability of appropriations, establish and evaluate
p.000579: activities to—
p.000579: (1) provide culturally competent information and education on autism spectrum disorder and other developmental
p.000579: disabil- ities to increase public awareness of developmental milestones;
p.000579: (2) promote research into the development and validation of reliable screening tools for individuals with autism
p.000579: spectrum disorder and other developmental disabilities and disseminate information regarding those screening
p.000579: tools;
p.000579: (3) promote early screening of individuals at higher risk for autism spectrum disorder and other developmental
p.000579: disabil- ities as early as practicable, given evidence-based screening techniques and interventions;
p.000579: (4) promote evidence-based screening techniques and inter- ventions for individuals with autism spectrum disorder
p.000579: and other developmental disabilities across their lifespan;
p.000579: (5) increase the number of individuals who are able to con- firm or rule out a diagnosis of autism spectrum
p.000579: disorder and other developmental disabilities;
p.000579: (6) increase the number of individuals able to provide evi- dence-based interventions for individuals diagnosed
p.000579: with au- tism spectrum disorder or other developmental disabilities; and
p.000579: (7) promote the use of evidence-based interventions for in- dividuals at higher risk for autism spectrum
p.000579: disorder and other developmental disabilities as early as practicable.
p.000579: (c) INFORMATION AND EDUCATION.—
p.000579: (1) IN GENERAL.—In carrying out subsection (b)(1), the Sec- retary, in collaboration with the Secretary of
p.000579: Education and the Secretary of Agriculture, shall, subject to the availability of appropriations, provide culturally
p.000579: competent information re- garding autism spectrum disorder and other developmental disabilities, risk
p.000579: factors, characteristics, identification, diag- nosis or rule out, and evidence-based interventions to meet the
p.000579: needs of individuals with autism spectrum disorder and other
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000579: Sec. 399BB PUBLIC HEALTH SERVICE ACT 580
p.000579:
p.000579: developmental disabilities across their lifespan and the needs of their families through—
p.000579: (A) Federal programs, including—
p.000579: (i) the Head Start program;
p.000579: (ii) the Early Start program;
p.000579: (iii) the Healthy Start program;
p.000579: (iv) programs under the Child Care and Develop- ment Block Grant Act of 1990;
p.000579: (v) programs under title XIX of the Social Security Act (particularly the Medicaid Early and Periodic
p.000579: Screening, Diagnosis and Treatment Program);
p.000579: (vi) the program under title XXI of the Social Se- curity Act (the State Children’s Health Insurance Pro-
p.000579: gram);
p.000579: (vii) the program under title V of the Social Secu- rity Act (the Maternal and Child Health Block Grant
p.000579: Program);
p.000579: (viii) the program under parts B and C of the In- dividuals with Disabilities Education Act;
p.000579: (ix) the special supplemental nutrition program for women, infants, and children established under section
p.000579: 17 of the Child Nutrition Act of 1966 (42
p.000579: U.S.C. 1786); and
p.000579: (x) the State grant program under the Rehabilita- tion Act of 1973.
p.000579: (B) State licensed child care facilities; and
p.000579: (C) other community-based organizations or points of entry for individuals with autism spectrum disorder
p.000579: and other developmental disabilities to receive services.
p.000579: (2) LEAD AGENCY.—
p.000579: (A) DESIGNATION.—As a condition on the provision of assistance or the conduct of activities under this
p.000579: section with respect to a State, the Secretary may require the Governor of the State—
p.000579: (i) to designate a public agency as a lead agency to coordinate the activities provided for under para-
p.000579: graph (1) in the State at the State level; and
p.000579: (ii) acting through such lead agency, to make available to individuals and their family members,
p.000579: guardians, advocates, or authorized representatives; providers; and other appropriate individuals in the
p.000579: State, comprehensive culturally competent information about State and local resources regarding autism spec- trum
p.000579: disorder and other developmental disabilities, risk factors, characteristics, identification, diagnosis or rule
p.000579: out, available services and supports (which may include respite care for caregivers of individuals with
p.000579: autism spectrum disorder or other developmental dis- abilities), and evidence-based interventions.
p.000579: (B) REQUIREMENTS OF AGENCY.—In designating the lead agency under subparagraph (A)(i), the Governor
p.000579: shall—
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p.000579: (i) select an agency that has demonstrated experi- ence and expertise in—
p.000579: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000581: PUBLIC HEALTH SERVICE ACT
p.000581: Sec. 399BB
p.000581:
p.000581: (I) autism spectrum disorder and other devel- opmental disability issues; and
p.000581: (II) developing, implementing, conducting, and administering programs and delivering edu- cation,
p.000581: information, and referral services (includ- ing technology-based curriculum-development services) to
p.000581: individuals with autism spectrum dis- order and developmental disabilities and their family members,
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p.000581: interdisciplinary training opportunities or opportunities to in- crease the number of sites able to diagnose or
p.000581: rule out individ- uals with autism spectrum disorder or other developmental disabilities across their lifespan
p.000581: and ensure that—
p.000581: (A) competitive grants or cooperative agreements are awarded to public or nonprofit agencies, including
p.000581: institu- tions of higher education, to expand existing or develop new maternal and child health
p.000581: interdisciplinary leadership education in neurodevelopmental and related disabilities programs (similar to the
p.000581: programs developed under section 501(a)(2) of the Social Security Act) in States that do not have such a
p.000581: program;
p.000581: (B) trainees under such training programs—
p.000581: (i) receive an appropriate balance of academic, clinical, and community opportunities;
p.000581: (ii) are culturally competent;
p.000581: (iii) are ethnically diverse;
p.000581: (iv) demonstrate a capacity to evaluate, diagnose or rule out, develop, and provide evidence-based inter-
p.000581: ventions to individuals with autism spectrum disorder and other developmental disabilities across their life-
p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
p.000581: (ii) an urban or rural area designated by the Sec- retary as an area with a shortage of personal health
p.000581: services (as described in section 330(b)(3)(A)).
p.000581: (3) TECHNICAL ASSISTANCE.—The Secretary may award one or more grants under this section to provide
p.000581: technical assist- ance to the network of interdisciplinary training programs.
p.000581: (4) BEST PRACTICES.—The Secretary shall promote re- search into additional valid and reliable tools
p.000581: for shortening the time required to confirm or rule out a diagnosis of autism spectrum disorder or other
p.000581: developmental disabilities and de- tecting individuals with autism spectrum disorder or other de- velopmental
p.000581: disabilities at an earlier age.
p.000581: (f) INTERVENTION.—The Secretary shall promote research, through grants or contracts, which may include grants
p.000581: or contracts to research centers or networks, to determine the evidence-based practices for interventions to
p.000581: improve the physical and behavioral
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000591: (a) ESTABLISHMENT OF ORAL HEALTH EDUCATION CAMPAIGN.— The Secretary, acting through the Director of the
p.000591: Centers for Dis- ease Control and Prevention and in consultation with professional oral health organizations,
p.000591: shall, subject to the availability of appro- priations, establish a 5-year national, public education campaign
p.000591: (referred to in this section as the ‘‘campaign’’) that is focused on oral health education, including
p.000591: prevention of oral disease such as early childhood and other caries, periodontal disease, and oral can- cer.
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p.000591: (b) REQUIREMENTS.—In establishing the campaign under sub- section (a), the Secretary shall—
p.000591: (1) ensure that activities are targeted towards specific pop- ulations such as children, pregnant women, parents, the
p.000591: elder- ly, individuals with disabilities, and ethnic and racial minority populations, including Indians, Alaska Natives
p.000591: and Native Ha- waiians (as defined in section 4(c) of the Indian Health Care Improvement Act) in a culturally
p.000591: and linguistically appropriate manner; and
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p.000593: PUBLIC HEALTH SERVICE ACT
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p.000593: (2) utilize science-based strategies to convey oral health prevention messages that include, but are not limited
p.000593: to, com- munity water fluoridation and dental sealants.
p.000593: (c) ACTION FOR DENTAL HEALTH PROGRAM.—
p.000593: (1) IN GENERAL.—The Secretary, in consultation with the Director of the Centers for Disease Control and
p.000593: Prevention and the Administrator of the Health Resources and Services Ad- ministration, may award grants,
p.000593: contracts, or cooperative agreements to eligible entities to collaborate with State or local public health
p.000593: officials, tribal health officials, oral health profes- sional organizations, and others, as appropriate, to develop
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p.000831: disorders; and
p.000831: (E) are licensed to practice medicine in one or more States.
p.000831: (3) DUTIES.—The Chief Medical Officer shall—
p.000831: (A) serve as a liaison between the Administration and providers of mental and substance use disorders preven-
p.000831: tion, treatment, and recovery services;
p.000831: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000831: Sec. 501 PUBLIC HEALTH SERVICE ACT 832
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p.000831: (B) assist the Assistant Secretary in the evaluation, organization, integration, and coordination of programs
p.000831: op- erated by the Administration;
p.000831: (C) promote evidence-based and promising best prac- tices, including culturally and linguistically
p.000831: appropriate practices, as appropriate, for the prevention and treatment of, and recovery from, mental and substance use
p.000831: disorders, including serious mental illness and serious emotional dis- turbances;
p.000831: (D) participate in regular strategic planning with the Administration;
p.000831: (E) coordinate with the Assistant Secretary for Plan- ning and Evaluation to assess the use of
p.000831: performance metrics to evaluate activities within the Administration re- lated to mental and substance use disorders;
p.000831: and
p.000831: (F) coordinate with the Assistant Secretary to ensure mental and substance use disorders grant programs within
p.000831: the Administration consistently utilize appropriate per- formance metrics and evaluation designs.
p.000831: (h) SERVICES OF EXPERTS.—
p.000831: (1) IN GENERAL.—The Assistant Secretary may obtain (in accordance with section 3109 of title 5, United States
p.000831: Code, but without regard to the limitation in such section on the number of days or the period of service) the
p.000831: services of not more than 20 experts or consultants who have professional qualifications. Such experts and
p.000831: consultants shall be obtained for the Admin- istration and for each of its agencies.
p.000831: (2) COMPENSATION AND EXPENSES.—
p.000831: (A) Experts and consultants whose services are ob- tained under paragraph (1) shall be paid or reimbursed for
p.000831: their expenses associated with traveling to and from their assignment location in accordance with sections
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p.000833: Education, Labor, and Pensions and the Committee on Appropriations of the Senate; and
p.000833: (B) post such plan on the Internet website of the Ad- ministration.
p.000833: (4) CONTENTS.—The strategic plan developed under para- graph (1) shall—
p.000833: (A) identify strategic priorities, goals, and measurable objectives for mental and substance use disorders activities
p.000833: and programs operated and supported by the Administra- tion, including priorities to prevent or eliminate
p.000833: the bur- den of mental and substance use disorders;
p.000833: (B) identify ways to improve the quality of services for individuals with mental and substance use disorders,
p.000833: and to reduce homelessness, arrest, incarceration, violence, in- cluding self-directed violence, and unnecessary
p.000833: hospitaliza- tion of individuals with a mental or substance use dis- order, including adults with a
p.000833: serious mental illness or children with a serious emotional disturbance;
p.000833: (C) ensure that programs provide, as appropriate, ac- cess to effective and evidence-based prevention,
p.000833: diagnosis, intervention, treatment, and recovery services, including culturally and linguistically appropriate
p.000833: services, as appro-
p.000833: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000833:
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p.000833:
p.000833: Sec. 501 PUBLIC HEALTH SERVICE ACT 834
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p.000833:
p.000833: priate, for individuals with a mental or substance use dis- order;
p.000833: (D) identify opportunities to collaborate with the Health Resources and Services Administration to
p.000833: develop or improve—
p.000833: (i) initiatives to encourage individuals to pursue careers (especially in rural and underserved areas and with
p.000833: rural and underserved populations) as psychia- trists, including child and adolescent psychiatrists,
p.000833: psychologists, psychiatric nurse practitioners, physi- cian assistants, clinical social workers, certified
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p.000835: (a) IN GENERAL.—There shall be established within the Admin- istration a National Mental Health and Substance Use
p.000835: Policy Lab- oratory (referred to in this section as the ‘‘Laboratory’’).
p.000835: (b) RESPONSIBILITIES.—The Laboratory shall—
p.000835: (1) continue to carry out the authorities and activities that were in effect for the Office of Policy, Planning, and
p.000835: Innovation as such Office existed prior to the date of enactment of the Helping Families in Mental Health
p.000835: Crisis Reform Act of 2016;
p.000835: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000835:
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p.000837: 837
p.000837: PUBLIC HEALTH SERVICE ACT
p.000837: Sec. 501A
p.000837:
p.000837: (2) identify, coordinate, and facilitate the implementation of policy changes likely to have a significant
p.000837: effect on mental health, mental illness, recovery supports, and the prevention and treatment of substance use
p.000837: disorder services;
p.000837: (3) work with the Center for Behavioral Health Statistics and Quality to collect, as appropriate, information
p.000837: from grant- ees under programs operated by the Administration in order to evaluate and disseminate information on
p.000837: evidence-based prac- tices, including culturally and linguistically appropriate serv- ices, as appropriate, and
p.000837: service delivery models;
p.000837: (4) provide leadership in identifying and coordinating poli- cies and programs, including evidence-based programs,
p.000837: related to mental and substance use disorders;
p.000837: (5) periodically review programs and activities operated by the Administration relating to the diagnosis or
p.000837: prevention of, treatment for, and recovery from, mental and substance use disorders to—
p.000837: (A) identify any such programs or activities that are duplicative;
p.000837: (B) identify any such programs or activities that are not evidence-based, effective, or efficient; and
p.000837: (C) formulate recommendations for coordinating, elimi- nating, or improving programs or activities
p.000837: identified under subparagraph (A) or (B) and merging such programs or activities into other successful programs or
p.000837: activities;
p.000837: (6) issue and periodically update information for entities applying for grants or cooperative agreements
p.000837: from the Sub- stance Abuse and Mental Health Services Administration in order to—
p.000837: (A) encourage the implementation and replication of evidence-based practices; and
p.000837: (B) provide technical assistance to applicants for fund- ing, including with respect to justifications for such
p.000837: pro- grams and activities; and
p.000837: (7) carry out other activities as deemed necessary to con- tinue to encourage innovation and disseminate
p.000837: evidence-based programs and practices.
p.000837: (c) EVIDENCE-BASED PRACTICES AND SERVICE DELIVERY MOD-
p.000837: ELS.—
p.000837:
p.000837:
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p.000837: (A) the Chief Medical Officer appointed under section 501(g);
p.000837: (B) representatives of the National Institute of Mental Health, the National Institute on Drug Abuse, and the Na-
p.000837: tional Institute on Alcohol Abuse and Alcoholism, on an ongoing basis;
p.000837: (C) other appropriate Federal agencies;
p.000837: (D) clinical and analytical experts with expertise in psychiatric medical care and clinical psychological
p.000837: care, health care management, education, corrections health care, and mental health court systems, as
p.000837: appropriate; and
p.000837: (E) other individuals and agencies as determined ap- propriate by the Assistant Secretary.
p.000837: (d) DEADLINE FOR BEGINNING IMPLEMENTATION.—The Labora- tory shall begin implementation of this section not later
p.000837: than Janu- ary 1, 2018.
p.000837: (e) PROMOTING INNOVATION.—
p.000837: (1) IN GENERAL.—The Assistant Secretary, in coordination with the Laboratory, may award grants to States, local
p.000837: govern- ments, Indian tribes or tribal organizations (as such terms are defined in section 4 of the Indian
p.000837: Self-Determination and Edu- cation Assistance Act), educational institutions, and nonprofit organizations to
p.000837: develop evidence-based interventions, includ- ing culturally and linguistically appropriate services, as appro-
p.000837: priate, for—
p.000837: (A) evaluating a model that has been scientifically demonstrated to show promise, but would benefit from fur-
p.000837: ther applied development, for—
p.000837: (i) enhancing the prevention, diagnosis, interven- tion, and treatment of, and recovery from, mental ill-
p.000837: ness, serious emotional disturbances, substance use disorders, and co-occurring illness or disorders; or
p.000837: (ii) integrating or coordinating physical health services and mental and substance use disorders serv- ices;
p.000837: and
p.000837: (B) expanding, replicating, or scaling evidence-based programs across a wider area to enhance effective
p.000837: screen- ing, early diagnosis, intervention, and treatment with re- spect to mental illness, serious mental
p.000837: illness, serious emo- tional disturbances, and substance use disorders, primarily by—
p.000837:
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p.000837: January 30, 2020
p.000837: (i) applying such evidence-based programs to the delivery of care, including by training staff in effective
p.000837: evidence-based treatments; or
p.000837: (ii) integrating such evidence-based programs into models of care across specialties and jurisdictions.
p.000837: (2) CONSULTATION.—In awarding grants under this sub- section, the Assistant Secretary shall, as
...

p.000845: use dis- order; or
p.000845: (B) has a policy of excluding individuals from sub- stance use disorder services due to the existence
p.000845: or sus- picion of mental illness.
p.000845: (d) TERM OF THE AWARDS.—No entity may receive a grant, con- tract, or cooperative agreement under subsection (a) for
p.000845: more than 5 years.
p.000845: (e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this
p.000845: section$41,304,000 for each of fiscal years 2018 through 2022.
p.000845: SEC. 506A. ø290aa–5a¿ ALCOHOL AND DRUG PREVENTION OR TREAT-
p.000845: MENT SERVICES FOR INDIANS AND NATIVE ALASKANS. 5
p.000845: (a) IN GENERAL.—The Secretary shall award grants, contracts, or cooperative agreements to public and private
p.000845: nonprofit entities, including Native Alaskan entities and Indian tribes and tribal or- ganizations, for the
p.000845: purpose of providing alcohol and drug preven- tion or treatment services for Indians and Native Alaskans.
p.000845: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000845: shall give priority to applicants that—
p.000845: (1) propose to provide alcohol and drug prevention or treat- ment services on reservations;
p.000845: (2) propose to employ culturally-appropriate approaches, as determined by the Secretary, in providing such services;
p.000845: and
p.000845: (3) have provided prevention or treatment services to Na- tive Alaskan entities and Indian tribes and tribal
p.000845: organizations for at least 1 year prior to applying for a grant under this sec- tion.
p.000845: (c) DURATION.—The Secretary shall award grants, contracts, or cooperative agreements under subsection (a) for a period
p.000845: not to ex- ceed 5 years.
p.000845:
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p.000845: January 30, 2020
p.000845: 5 Section 3307 of Public Law 106–310 (114 Stat. 1216) establishes a Commission on Indian and Native
p.000845: Alaskan Health Care and provides that the Commission ‘‘shall examine the health concerns of Indians and
p.000845: Native Alaskans who reside on reservations and tribal lands’’.
p.000845: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000847: 847
p.000847: PUBLIC HEALTH SERVICE ACT
p.000847: Sec. 507
p.000847:
p.000847: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000847: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000847: Secretary may reasonably require.
p.000847: (e) EVALUATION.—An entity that receives a grant, contract, or cooperative agreement under subsection (a) shall
...

p.000857: in recovery so that chil- dren are in safe, stable home environments and receive appro- priate health care
p.000857: services.
p.000857: (b) PRIORITY.—In awarding grants, contracts, or cooperative agreements under subsection (a), the Secretary
p.000857: shall give priority to applicants who propose to—
p.000857: (1) apply evidence-based and cost-effective methods;
p.000857: (2) coordinate the provision of services with other social service agencies in the community, including
p.000857: educational, juve- nile justice, child welfare, substance abuse, and mental health agencies;
p.000857: (3) provide a continuum of integrated treatment services, including case management, for children,
p.000857: adolescents, and young adults with substance use disorders, including children, adolescents, and young adults with
p.000857: co-occurring mental illness and substance use disorders, and their families;
p.000857: (4) provide treatment that is gender-specific and culturally appropriate;
p.000857: (5) involve and work with families of children, adolescents, and young adults receiving services; and
p.000857: (6) provide aftercare services for children, adolescents, and young adults and their families after completion
p.000857: of treatment.
p.000857: (c) DURATION OF GRANTS.—The Secretary shall award grants, contracts, or cooperative agreements under
p.000857: subsection (a) for peri- ods not to exceed 5 fiscal years.
p.000857: (d) APPLICATION.—An entity desiring a grant, contract, or coop- erative agreement under subsection (a) shall submit an
p.000857: application to the Secretary at such time, in such manner, and accompanied by such information as the
p.000857: Secretary may reasonably require.
p.000857: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000857:
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p.000859: 859
p.000859: PUBLIC HEALTH SERVICE ACT
p.000859: Sec. 514B
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p.000871: (C) PEER REVIEW.—Research under subparagraph (A) shall meet current Federal standards for scientific peer re-
p.000871: view.
p.000871: (2) AUTHORIZATION OF APPROPRIATIONS.—There are author- ized to be appropriated to carry out this subsection
p.000871: $3,000,000 for each of the fiscal years 2018 through 2022 8
p.000871: (g) REDUCING UNDERAGE DRINKING THROUGH SCREENING AND
p.000871: BRIEF INTERVENTION.—
p.000871: (1) GRANTS TO PEDIATRIC HEALTH CARE PROVIDERS TO RE- DUCE UNDERAGE DRINKING.—The Assistant Secretary
p.000871: may make grants to eligible entities to increase implementation of practices for reducing the prevalence of
p.000871: alcohol use among indi- viduals under the age of 21, including college students.
p.000871: (2) PURPOSES.—Grants under this subsection shall be made to improve—
p.000871: (A) screening children and adolescents for alcohol use;
p.000871: (B) offering brief interventions to children and adoles- cents to discourage such use;
p.000871: (C) educating parents about the dangers of, and meth- ods of discouraging, such use;
p.000871: (D) diagnosing and treating alcohol use disorders; and
p.000871: (E) referring patients, when necessary, to other appro- priate care.
p.000871: (3) USE OF FUNDS.—An entity receiving a grant under this subsection may use such funding for the purposes identified in
p.000871: paragraph (2) by—
p.000871: (A) providing training to health care providers;
p.000871: (B) disseminating best practices, including culturally and linguistically appropriate best practices, as
p.000871: appro- priate, and developing and distributing materials; and
p.000871: (C) supporting other activities, as determined appro- priate by the Assistant Secretary.
p.000871: (4) APPLICATION.—To be eligible to receive a grant under this subsection, an entity shall submit an
p.000871: application to the Assistant Secretary at such time, and in such manner, and ac- companied by such information as the
p.000871: Assistant Secretary may require. Each application shall include—
p.000871: (A) a description of the entity;
p.000871: (B) a description of activities to be completed;
p.000871:
p.000871:
p.000871:
p.000871:
p.000871: January 30, 2020
p.000871: 8 Missing period so in law. Section 9016(4) of Public Law 114-255 amends subsection (f)(2) by striking ‘‘$6,000,000 for
p.000871: fiscal year 2007’’ and all that follows through the period at the end and inserting ‘‘$3,000,000 for each of the fiscal
p.000871: years 2018 through 2022’’.
p.000871: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000871:
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p.000873: PUBLIC HEALTH SERVICE ACT
p.000873: Sec. 519D
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p.000873:
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p.000873: January 30, 2020
p.000873: 9 So in law. Probably should read ‘‘; and’’. See section 3110 of Public Law 106–310 (114 Stat. 1185).
p.000873: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000875: PUBLIC HEALTH SERVICE ACT
p.000875: Sec. 520
p.000875:
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p.000875: (3) collaborate with the Director of the National Institute of Mental Health and the Chief Medical
p.000875: Officer, appointed under section 501(g), to ensure that, as appropriate, programs related to the prevention and
p.000875: treatment of mental illness and the promotion of mental health and recovery support are car- ried out in
p.000875: a manner that reflects the best available science and evidence-based practices, including culturally and
p.000875: linguis- tically appropriate services, as appropriate;
p.000875: (4) collaborate with the Department of Education and the Department of Justice to develop programs to assist
p.000875: local com- munities in addressing violence among children and adoles- cents;
p.000875: (5) develop and coordinate Federal prevention policies and programs and to assure increased focus on the
p.000875: prevention of mental illness and the promotion of mental health, including through programs that reduce risk
p.000875: and promote resiliency;
p.000875: (6) in collaboration with the Director of the National Insti- tute of Mental Health, develop improved methods of
p.000875: treating individuals with mental health problems and improved meth- ods of assisting the families of such
p.000875: individuals;
p.000875: (7) administer the mental health services block grant pro- gram authorized in section 1911;
p.000875: (8) promote policies and programs at Federal, State, and local levels and in the private sector that foster
p.000875: independence, increase meaningful participation of individuals with mental illness in programs and activities
p.000875: of the Administration, and protect the legal rights of persons with mental illness, includ- ing carrying
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p.000885: mental and substance use disorders.
p.000885: (7) Creating a network infrastructure to link institutions of higher education with health care providers who
p.000885: treat mental and substance use disorders.
p.000885: (8) Providing mental and substance use disorders preven- tion and treatment services to students, which may
p.000885: include re- covery support services and programming and early interven- tion, treatment, and management,
p.000885: including through the use of telehealth services.
p.000885: (9) Conducting research through a counseling or health center at the institution of higher education involved
p.000885: regarding improving the behavioral health of students through clinical services, outreach, prevention, or
p.000885: academic success, in a man- ner that is in compliance with all applicable personal privacy laws.
p.000885: (10) Supporting student groups on campus, including ath- letic teams, that engage in activities to
p.000885: educate students, in- cluding activities to reduce stigma surrounding mental and be- havioral disorders, and promote
p.000885: mental health.
p.000885: (11) Employing appropriately trained staff.
p.000885: (12) Developing and supporting evidence-based and emerg- ing best practices, including a focus on culturally
p.000885: and linguis- tically appropriate best practices.
p.000885: (c) ELIGIBLE GRANT RECIPIENTS.—Any institution of higher edu- cation receiving a grant under this section may carry out
p.000885: activities under the grant through—
p.000885: (1) college counseling centers;
p.000885: (2) college and university psychological service centers;
p.000885: (3) mental health centers;
p.000885: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000887: PUBLIC HEALTH SERVICE ACT
p.000887: Sec. 520E–2
p.000887:
p.000887: (4) psychology training clinics; or
p.000887: (5) institution of higher education supported, evidence- based, mental health and substance use disorder
p.000887: programs.
p.000887: (d) APPLICATION.—To be eligible to receive a grant under this section, an institution of higher education
p.000887: shall prepare and submit an application to the Secretary at such time and in such manner as the Secretary
p.000887: may require. At a minimum, the application shall include the following:
p.000887: (1) A description of the population to be targeted by the program carried out under the grant, including
p.000887: veterans when- ever possible and appropriate, and of identified mental and substance use disorder needs of
...

p.000893: (1) have a history of interactions with law enforcement or the criminal justice system;
p.000893: (2) have recently been released from incarceration;
p.000893: (3) have a history of unsuccessful treatment in either an inpatient or outpatient setting;
p.000893: (4) have never followed through with outpatient services despite repeated referrals; or
p.000893: (5) are homeless.
p.000893: (c) USE OF FUNDS.—A State, political subdivision of a State, In- dian tribe, tribal organization, or private
p.000893: nonprofit organization that receives a grant, contract, or cooperative agreement under subsection (a) shall
p.000893: use funds received under such grant—
p.000893: (1) to provide fully integrated services rather than serial or parallel services;
p.000893: (2) to employ staff that are cross-trained in the diagnosis and treatment of both serious mental illness
p.000893: and substance abuse;
p.000893: (3) to provide integrated mental health and substance abuse services at the same location;
p.000893: (4) to provide services that are linguistically appropriate and culturally competent;
p.000893: (5) to provide at least 10 programs for integrated treat- ment of both mental illness and substance
p.000893: abuse at sites that
p.000893: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000893: Sec. 520J PUBLIC HEALTH SERVICE ACT 894
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p.000893: previously provided only mental health services or only sub- stance abuse services; and
p.000893: (6) to provide services in coordination with other existing public and private community programs.
p.000893: (d) CONDITION.—The Secretary shall ensure that a State, polit- ical subdivision of a State, Indian tribe, tribal
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p.000949: government would credit for purposes of determining whether the relevant requirements have been satisfied.
p.000949: PART K—MINORITY FELLOWSHIP PROGRAM
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p.000949: January 30, 2020
p.000949: SEC. 597. ø290ll¿ FELLOWSHIPS.
p.000949: (a) IN GENERAL.—The Secretary shall maintain a program, to be known as the Minority Fellowship Program,
p.000949: under which the Secretary shall award fellowships, which may include stipends, for the purposes of—
p.000949: (1) increasing the knowledge of mental and substance use disorders practitioners on issues related to
p.000949: prevention, treat- ment, and recovery support for individuals who are from racial and ethnic minority populations
p.000949: and who have a mental or substance use disorder;
p.000949: (2) improving the quality of mental and substance use dis- order prevention and treatment services delivered to racial
p.000949: and ethnic minority populations; and
p.000949: (3) increasing the number of culturally competent mental and substance use disorders professionals who
p.000949: teach, admin- ister services, conduct research, and provide direct mental or substance use disorder
p.000949: services to racial and ethnic minority populations.
p.000949: (b) TRAINING COVERED.—The fellowships awarded under sub- section (a) shall be for postbaccalaureate
p.000949: training (including for master’s and doctoral degrees) for mental and substance use dis- order treatment
p.000949: professionals, including in the fields of psychiatry, nursing, social work, psychology, marriage and family
p.000949: therapy, mental health counseling, and substance use disorder and addic- tion counseling.
p.000949: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000951: PUBLIC HEALTH SERVICE ACT
p.000951: Sec. 600
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p.000951: (c) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000951: $12,669,000 for each of fiscal years 2018 through 2022.
p.000951: SEC. 550. 24 ø290ee-10¿ SOBRIETY TREATMENT AND RECOVERY TEAMS.
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p.001019: preference to approved applications for programs that involve a comprehensive approach by several public or
p.001019: nonprofit private health or edu- cational entities to establish, enhance and expand educational pro- grams that
p.001019: will result in the development of a competitive appli- cant pool of individuals from disadvantaged
p.001019: backgrounds who de- sire to pursue health professions careers. In considering awards for such a comprehensive
p.001019: partnership approach, the following shall apply with respect to the entity involved:
p.001019: (1) The entity shall have a demonstrated commitment to such approach through formal agreements that have
p.001019: common objectives with institutions of higher education, school dis- tricts, and other community-based entities.
p.001019: (2) Such formal agreements shall reflect the coordination of educational activities and support services,
p.001019: increased link- ages, and the consolidation of resources within a specific geo- graphic area.
p.001019: (3) The design of the educational activities involved shall provide for the establishment of a
p.001019: competitive health profes- sions applicant pool of individuals from disadvantaged back- grounds by enhancing
p.001019: the total preparation (academic and so- cial) of such individuals to pursue a health professions career.
p.001019: (4) The programs or activities under the award shall focus on developing a culturally competent health care
p.001019: workforce that will serve the unserved and underserved populations within the geographic area.
p.001019: (c) EQUITABLE ALLOCATION OF FINANCIAL ASSISTANCE.—The Secretary, to the extent practicable, shall ensure that
p.001019: services and activities under subsection (a) are adequately allocated among the various racial and ethnic
p.001019: populations who are from disadvantaged backgrounds.
p.001019: (d) MATCHING REQUIREMENTS.—The Secretary may require that an entity that applies for a grant or contract
p.001019: under subsection (a), provide non-Federal matching funds, as appropriate, to ensure the institutional commitment of
p.001019: the entity to the projects funded
p.001019: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001021: PUBLIC HEALTH SERVICE ACT
p.001021: Sec. 741
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p.001197: (i) shall promote full participation by individuals with traumatic brain injury and their families in deci- sion
p.001197: making regarding the services and supports; and
p.001197: (ii) shall be designed for children, youth, and adults with traumatic brain injury.
p.001197: (B) To focus on outreach to underserved and inappro- priately served individuals, such as individuals in
p.001197: institu- tional settings, individuals with low socioeconomic re-
p.001197: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001197: Sec. 1252 PUBLIC HEALTH SERVICE ACT 1198
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p.001197: January 30, 2020
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p.001197: sources, individuals in rural communities, and individuals in culturally and linguistically diverse communities.
p.001197: (C) To award contracts to nonprofit entities for con- sumer or family service access training, consumer
p.001197: support, peer mentoring, and parent to parent programs.
p.001197: (D) To develop individual and family service coordina- tion or case management systems.
p.001197: (E) To support other needs identified by the advisory board under subsection (b) for the State or
p.001197: American In- dian consortium involved.
p.001197: (2) BEST PRACTICES.—
p.001197: (A) IN GENERAL.—State or American Indian consor- tium services and supports provided under a grant under
p.001197: this section shall reflect the best practices in the field of traumatic brain injury, shall be in compliance
p.001197: with title II of the Americans with Disabilities Act of 1990, and shall be supported by quality assurance
p.001197: measures as well as state-of-the-art health care and integrated community sup- ports, regardless of the severity of
p.001197: injury.
p.001197: (B) DEMONSTRATION BY STATE AGENCY.—The State or American Indian consortium agency responsible for admin- istering
p.001197: amounts received under a grant under this section shall demonstrate that it has obtained knowledge and ex-
p.001197: pertise of traumatic brain injury and the unique needs as- sociated with traumatic brain injury.
p.001197: (3) STATE CAPACITY BUILDING.—A State or American In- dian consortium may use amounts received under a
p.001197: grant under this section to—
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p.001201: disclosure of indi- vidually identifiable information consistent with all appli- cable privacy laws and
p.001201: regulations; and
p.001201: (D) integrating, as appropriate, the training described in paragraphs (1) through (4) of subsection (c) with
p.001201: train- ing programs, in effect on the date of enactment of this section, for health care and social service
p.001201: providers for vic- tims of intimate partner violence, sexual assault, stalking, child abuse, child neglect, child
p.001201: maltreatment, and child sexual exploitation.
p.001201: (c) GRANTS.—The Secretary may award grants to appropriate entities to train health care and social service
p.001201: providers to—
p.001201: (1) identify potential human trafficking victims;
p.001201: (2) implement best practices for working with law enforce- ment to report and facilitate communication with human traf-
p.001201: ficking victims, in accordance with all applicable Federal, State, local, and tribal laws, including
p.001201: legal confidentiality re- quirements for patients and health care and social service pro- viders;
p.001201: (3) implement best practices for referring such victims to appropriate health care, social, or victims
p.001201: service agencies or organizations; and
p.001201: (4) provide such victims with coordinated, age-appropriate, culturally relevant, trauma-informed,
p.001201: patient-centered, and evidence-based care.
p.001201: (d) CONSIDERATION IN AWARDING GRANTS.—The Secretary, in making awards under this section, shall give
p.001201: consideration to—
p.001201: (1) geography;
p.001201: (2) the demographics of the population to be served;
p.001201: (3) the predominant types of human trafficking cases in- volved; and
p.001201: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001203: PUBLIC HEALTH SERVICE ACT
p.001203: Sec. 1261
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p.001203: January 30, 2020
p.001203: (4) health care and social service provider profiles.
p.001203: (e) DATA COLLECTION AND REPORTING.—
p.001203: (1) IN GENERAL.—The Secretary shall collect data and re- port on the following:
p.001203: (A) The total number of entities that received a grant under this section.
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p.001477: health care services within the geographic area to be served;
p.001477: (B) not less than one community-based organization that is organized solely for the purpose of providing
p.001477: HIV- related support services to individuals with HIV/AIDS;
p.001477: (C) grantees under section 2671, or, if none are oper- ating in the area, representatives in the area
p.001477: of organiza- tions with a history of serving children, youth, women, and families living with HIV; and
p.001477: (D) the types of entities described in section 2602(b)(2).
p.001477: The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium.
p.001477: (d) DEFINITION.—As used in section 2611, the term ‘‘family cen- tered care’’ means the system of services
p.001477: described in this section that is targeted specifically to the special needs of infants, children, women, and
p.001477: families. Family centered care shall be based on a partnership between parents, professionals, and the
p.001477: community de- signed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum
p.001477: of care for children, women, and families with HIV/AIDS.
p.001477: (e) PRIORITY.—In providing assistance under subsection (a), the State shall, among applicants that meet the
p.001477: requirements of this section, give priority—
p.001477: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001477: Sec. 2614 PUBLIC HEALTH SERVICE ACT 1478
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p.001477: January 30, 2020
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p.001477: (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for
p.001477: adult and pediatric HIV-related care demonstration projects; and then
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p.001525: Sec. 2689
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p.001525: individual with HIV/AIDS, without regard to whether the indi- vidual has AIDS and without regard to whether the
p.001525: conditions arise from HIV.
p.001525: (3) COUNSELING.—The term ‘‘counseling’’ means such coun- seling provided by an individual trained to provide such coun-
p.001525: seling.
p.001525: (4) FAMILY-CENTERED CARE.—The term ‘‘family-centered care’’ means the system of services described in
p.001525: this title that is targeted specifically to the special needs of infants, children, women and families.
p.001525: Family-centered care shall be based on a partnership between parents, professionals, and the commu- nity
p.001525: designed to ensure an integrated, coordinated, culturally sensitive, and community-based continuum of care for
p.001525: children, women, and families with HIV/AIDS.
p.001525: (5) FAMILIES WITH HIV/AIDS.—The term ‘‘families with HIV/ AIDS’’ means families in which one or more members
p.001525: have HIV/AIDS.
p.001525: (6) HIV.—The term ‘‘HIV’’ means infection with the human immunodeficiency virus.
p.001525: (7) HIV/AIDS.—
p.001525: (A) IN GENERAL.—The term ‘‘HIV/AIDS’’ means HIV, and includes AIDS and any condition arising from AIDS.
p.001525: (B) COUNTING OF CASES.—The term ‘‘living cases of HIV/AIDS’’, with respect to the counting of cases in a geo-
p.001525: graphic area during a period of time, means the sum of—
p.001525: (i) the number of living non-AIDS cases of HIV in the area; and
p.001525: (ii) the number of living cases of AIDS in the area.
p.001525: (C) NON-AIDS CASES.—The term ‘‘non-AIDS’’, with re- spect to a case of HIV, means that the individual involved
p.001525: has HIV but does not have AIDS.
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p.001529: thera- peutics, the Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve
p.001529: the following, as applicable:
p.001529: (i) For fiscal year 2007, $7,000,000.
p.001529: (ii) For fiscal year 2008, $7,300,000.
p.001529: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001529: Sec. 2693 PUBLIC HEALTH SERVICE ACT 1530
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p.001529: January 30, 2020
p.001529:
p.001529: (iii) For fiscal year 2009, $7,500,000.
p.001529: (iv) For fiscal year 2010, $8,763,000.
p.001529: (v) For fiscal year 2011, $9,202,000.
p.001529: (vi) For fiscal year 2012, $9,662,000.
p.001529: (vii) For fiscal year 2013, $10,145,000.
p.001529: (C) For planning grants, capacity-building grants, and services grants to health care providers who have a history of
p.001529: providing culturally and linguistically appropriate care and services to racial and ethnic minorities, the
p.001529: Secretary shall, of the amount appropriated for a fiscal year under subsection (a), reserve the following, as
p.001529: applicable:
p.001529: (i) For fiscal year 2007, $53,400,000.
p.001529: (ii) For fiscal year 2008, $55,400,000.
p.001529: (iii) For fiscal year 2009, $57,400,000.
p.001529: (iv) For fiscal year 2010, $61,343,000. (v) For fiscal year 2011, $64,410,000.
p.001529: (vi) For fiscal year 2012, $67,631,000.
p.001529: (vii) For fiscal year 2013, $71,012,000.
p.001529: (D) For eliminating racial and ethnic disparities in the delivery of comprehensive, culturally and linguistically ap-
p.001529: propriate care services for HIV disease for women, infants, children, and youth, the Secretary shall, of the amount ap-
p.001529: propriated under subsection (a), reserve the following, as applicable:
p.001529: (i) For fiscal year 2010, $20,448,000.
p.001529: (ii) For fiscal year 2011, $21,470,000.
p.001529: (iii) For fiscal year 2012, $22,543,000.
p.001529: (iv) For fiscal year 2013, $23,671,000.
p.001529: (E) For increasing the training capacity of centers to expand the number of health care professionals with
p.001529: treat- ment expertise and knowledge about the most appropriate standards of HIV disease-related treatments and
p.001529: medical care for racial and ethnic minority adults, adolescents, and children with HIV disease, the Secretary
p.001529: shall, of the amount appropriated under subsection (a), reserve the fol- lowing, as applicable:
p.001529: (i) For fiscal year 2010, $8,763,000.
p.001529: (ii) For fiscal year 2011, $9,201,000.
p.001529: (iii) For fiscal year 2012, $9,662,000.
p.001529: (iv) For fiscal year 2013, $10,144,000.
p.001529: (c) CONSISTENCY WITH PRIOR PROGRAM.—With respect to the purpose described in subsection (a), the Secretary
p.001529: shall carry out this section consistent with the activities carried out under this title by the
...

p.001561: patient advocates in- cluding those representing individuals with limited English pro- ficiency, and other
p.001561: qualified individuals.
p.001561: (b) REQUIREMENTS.—The standards for the summary of bene- fits and coverage developed under subsection (a)
p.001561: shall provide for the following:
p.001561: (1) APPEARANCE.—The standards shall ensure that the summary of benefits and coverage is presented in a
p.001561: uniform format that does not exceed 4 pages in length and does not in- clude print smaller than 12-point font.
p.001561: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001563: 1563
p.001563: PUBLIC HEALTH SERVICE ACT
p.001563: Sec. 2715
p.001563:
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p.001563: January 30, 2020
p.001563: (2) LANGUAGE.—The standards shall ensure that the sum- mary is presented in a culturally and linguistically appropriate
p.001563: manner and utilizes terminology understandable by the aver- age plan enrollee.
p.001563: (3) CONTENTS.—The standards shall ensure that the sum- mary of benefits and coverage includes—
p.001563: (A) uniform definitions of standard insurance terms and medical terms (consistent with subsection (g)) so
p.001563: that consumers may compare health insurance coverage and understand the terms of coverage (or exception to
p.001563: such coverage);
p.001563: (B) a description of the coverage, including cost shar- ing for—
p.001563: (i) each of the categories of the essential health benefits described in subparagraphs (A) through (J) of
p.001563: section 1302(b)(1) of the Patient Protection and Afford- able Care Act; and
p.001563: (ii) other benefits, as identified by the Secretary;
p.001563: (C) the exceptions, reductions, and limitations on cov- erage;
p.001563: (D) the cost-sharing provisions, including deductible, coinsurance, and co-payment obligations;
p.001563: (E) the renewability and continuation of coverage pro- visions;
p.001563: (F) a coverage facts label that includes examples to il- lustrate common benefits scenarios, including pregnancy
p.001563: and serious or chronic medical conditions and related cost sharing, such scenarios to be based on recognized
p.001563: clinical practice guidelines;
p.001563: (G) a statement of whether the plan or coverage—
p.001563: (i) provides minimum essential coverage (as de- fined under section 5000A(f) of the Internal Revenue Code
p.001563: 1986); and
p.001563: (ii) ensures that the plan or coverage share of the total allowed costs of benefits provided under the plan or
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p.001569: types of plans, and newer plans.
p.001569: (d) ADJUSTMENTS.—The Secretary may adjust the rates de- scribed in subsection (b) if the Secretary determines
p.001569: appropriate on account of the volatility of the individual market due to the estab- lishment of State Exchanges.
p.001569: (e) STANDARD HOSPITAL CHARGES.—Each hospital operating within the United States shall for each year establish (and
p.001569: update) and make public (in accordance with guidelines developed by the Secretary) a list of the
p.001569: hospital’s standard charges for items and services provided by the hospital, including for
p.001569: diagnosis-related groups established under section 1886(d)(4) of the Social Security Act.
p.001569: SEC. 2719. ø300gg–19¿ APPEALS PROCESS.
p.001569: (a) INTERNAL CLAIMS APPEALS.—
p.001569: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001569:
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p.001569: Sec. 2719 PUBLIC HEALTH SERVICE ACT 1570
p.001569:
p.001569: (1) IN GENERAL.—A group health plan and a health insur- ance issuer offering group or individual health
p.001569: insurance cov- erage shall implement an effective appeals process for appeals of coverage determinations and
p.001569: claims, under which the plan or issuer shall, at a minimum—
p.001569: (A) have in effect an internal claims appeal process;
p.001569: (B) provide notice to enrollees, in a culturally and lin- guistically appropriate manner, of available internal
p.001569: and external appeals processes, and the availability of any ap- plicable office of health insurance consumer
p.001569: assistance or ombudsman established under section 2793 to assist such enrollees with the appeals processes; and
p.001569: (C) allow an enrollee to review their file, to present evidence and testimony as part of the appeals process,
p.001569: and to receive continued coverage pending the outcome of the appeals process.
p.001569: (2) ESTABLISHED PROCESSES.—To comply with paragraph (1)—
p.001569: (A) a group health plan and a health insurance issuer offering group health coverage shall provide an internal
p.001569: claims and appeals process that initially incorporates the claims and appeals procedures (including urgent
p.001569: claims) set forth at section 2560.503–1 of title 29, Code of Federal Regulations, as published on November 21,
p.001569: 2000 (65 Fed. Reg. 70256), and shall update such process in accordance with any standards established by
p.001569: the Secretary of Labor for such plans and issuers; and
p.001569: (B) a health insurance issuer offering individual health coverage, and any other issuer not subject
p.001569: to sub- paragraph (A), shall provide an internal claims and ap- peals process that initially incorporates the
p.001569: claims and ap- peals procedures set forth under applicable law (as in ex- istence on the date of enactment of
p.001569: this section), and shall update such process in accordance with any standards es- tablished by the Secretary
p.001569: of Health and Human Services for such issuers.
p.001569: (b) EXTERNAL REVIEW.—A group health plan and a health in- surance issuer offering group or individual
p.001569: health insurance cov- erage—
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p.001705: before the date of the enactment of this title).
p.001705: (C) ADDITIONAL APPOINTMENTS.—Each Steering Com- mittee may recommend, if approved by a majority of voting members
p.001705: of the Committee, additional members to the Committee.
p.001705: (D) VACANCIES.—A vacancy in a Steering Committee shall be filled by an individual recommended by the Steer- ing
p.001705: Committee.
p.001705: SEC. 3303. ø42 U.S.C. 300mm–2¿ EDUCATION AND OUTREACH.
p.001705: The WTC Program Administrator shall institute a program that provides education and outreach on the
p.001705: existence and avail- ability of services under the WTC Program. The outreach and edu- cation program—
p.001705: (1) shall include—
p.001705: (A) the establishment of a public Web site with infor- mation about the WTC Program;
p.001705: (B) meetings with potentially eligible populations;
p.001705: (C) development and dissemination of outreach mate- rials informing people about the program; and
p.001705: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001705:
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p.001705:
p.001707: 1707
p.001707: PUBLIC HEALTH SERVICE ACT
p.001707: Sec. 3305
p.001707:
p.001707: (D) the establishment of phone information services;
p.001707: and
p.001707: (2) shall be conducted in a manner intended—
p.001707: (A) to reach all affected populations; and
p.001707: (B) to include materials for culturally and linguis- tically diverse populations.
p.001707: SEC. 3304. ø42 U.S.C. 300mm–3¿ UNIFORM DATA COLLECTION AND ANALYSIS.
p.001707: (a) IN GENERAL.—The WTC Program Administrator shall pro- vide for the uniform collection of data,
p.001707: including claims data (and analysis of data and regular reports to the Administrator) on the prevalence of
p.001707: WTC-related health conditions and the identification of new WTC-related health conditions. Such data shall be collected
p.001707: for all individuals provided monitoring or treatment benefits under subtitle B and regardless of their place of
p.001707: residence or Clinical Cen- ter of Excellence through which the benefits are provided. The WTC Program
p.001707: Administrator shall provide, through the Data Cen- ters or otherwise, for the integration of such data into
p.001707: the moni- toring and treatment program activities under this title.
p.001707: (b) COORDINATING THROUGH CENTERS OF EXCELLENCE.—Each Clinical Center of Excellence shall collect data
p.001707: described in sub- section (a) and report such data to the corresponding Data Center for analysis by such
p.001707: Data Center.
p.001707: (c) COLLABORATION WITH WTC HEALTH REGISTRY.—The WTC Program Administrator shall provide for collaboration between
p.001707: the Data Centers and the World Trade Center Health Registry de- scribed in section 3342.
p.001707: (d) PRIVACY.—The data collection and analysis under this sec- tion shall be conducted and maintained in
p.001707: a manner that protects the confidentiality of individually identifiable health information consistent with
p.001707: applicable statutes and regulations, including, as applicable, HIPAA privacy and security law (as defined
p.001707: in section 3009(a)(2)) and section 552a of title 5, United States Code.
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General/Other / remote/rural communities

Searching for indicator rural area:

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p.000297:
p.000297: (C) acquire personal protective equipment for emer- gency medical services personnel as required by the Occu-
p.000297: pational Safety and Health Administration.
p.000297: (d) GRANT AMOUNTS.—Each grant awarded under this section shall be in an amount not to exceed $200,000.
p.000297: (e) DEFINITIONS.—In this section:
p.000297: (1) The term ‘‘emergency medical services’’—
p.000297: (A) means resources used by a public or private non- profit licensed entity to deliver medical care
p.000297: outside of a medical facility under emergency conditions that occur as a result of the condition of the
p.000297: patient; and
p.000297: (B) includes services delivered (either on a com- pensated or volunteer basis) by an emergency
p.000297: medical services provider or other provider that is licensed or cer- tified by the State involved as an
p.000297: emergency medical tech- nician, a paramedic, or an equivalent professional (as de- termined by the State).
p.000297: (2) The term ‘‘rural area’’ means—
p.000297: (A) a nonmetropolitan statistical area;
p.000297: (B) an area designated as a rural area by any law or regulation of a State; or
p.000297: (C) a rural census tract of a metropolitan statistical area (as determined under the most recent rural
p.000297: urban commuting area code as set forth by the Office of Manage- ment and Budget).
p.000297: (f) MATCHING REQUIREMENT.—The Secretary may not award a grant under this section to an entity unless the entity agrees
p.000297: that the entity will make available (directly or through contributions from other public or private entities)
p.000297: non-Federal contributions to- ward the activities to be carried out under the grant in an amount equal to 10 percent of
p.000297: the amount received under the grant.
p.000297: (g) AUTHORIZATION OF APPROPRIATIONS.—
p.000297: (1) IN GENERAL.—There are authorized to be appropriated to carry out this section such sums as may be
p.000297: necessary for each of fiscal years 2019 through 2023.
p.000297: (2) ADMINISTRATIVE COSTS.—The Secretary may use not more than 10 percent of the amount appropriated under para-
p.000297: graph (1) for a fiscal year for the administrative expenses of carrying out this section.
p.000297: SEC. 330K. ø254c–16¿ MENTAL HEALTH SERVICES DELIVERED VIA TELEHEALTH.
p.000297: (a) DEFINITIONS.—In this section:
p.000297: (1) ELIGIBLE ENTITY.—The term ‘‘eligible entity’’ means a public or nonprofit private telehealth provider
p.000297: network that of- fers services that include mental health services provided by qualified mental health
p.000297: providers.
p.000297: (2) QUALIFIED MENTAL HEALTH PROFESSIONALS.—The term ‘‘qualified mental health professionals’’ refers to
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p.000305:
p.000305: (j) For the purposes of this subpart and subpart III:
p.000305: (1) The term ‘‘Department’’ means the Department of Health and Human Services.
p.000305: (2) The term ‘‘Loan Repayment Program’’ means the Na- tional Health Service Corps Loan Repayment Program
p.000305: estab- lished under section 338B.
p.000305: (3) The term ‘‘Scholarship Program’’ means the National Health Service Corps Scholarship Program
p.000305: established under section 338A.
p.000305: (4) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.000305: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.000305: American Samoa, and the Trust Territory of the Pacific Islands.
p.000305: (5) The terms ‘‘full time’’ and ‘‘full-time’’ mean a minimum of 40 hours per week in a clinical practice, for
p.000305: a minimum of 45 weeks per year.
p.000305: (6) The terms ‘‘half time’’ and ‘‘half-time’’ mean a min- imum of 20 hours per week (not to exceed 39 hours
p.000305: per week) in a clinical practice, for a minimum of 45 weeks per year.
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p.000305: January 30, 2020
p.000305: DESIGNATION OF HEALTH PROFESSIONAL SHORTAGE AREAS
p.000305: SEC. 332. ø254e¿ (a)(1) For purposes of this subpart the term ‘‘health professional shortage area’’ means (A)
p.000305: an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision and
p.000305: which is a rational area for the deliv- ery of health services) which the Secretary determines has a health manpower
p.000305: shortage, (B) a population group which the Secretary de- termines has such a shortage, or (C) a public or
p.000305: nonprofit private medical facility or other public facility which the Secretary deter- mines has such a
p.000305: shortage. All Federally qualified health centers and rural health clinics, as defined in section 1861(aa) of the
p.000305: Social Security Act (42 U.S.C. 1395x(aa)), that meet the requirements of section 334 shall be
p.000305: automatically designated as having such a shortage. The Secretary shall not remove an area from the
p.000305: areas determined to be health professional shortage areas under subpara- graph (A) of the preceding sentence
p.000305: until the Secretary has af- forded interested persons and groups in such area an opportunity to provide
p.000305: data and information in support of the designation as a health professional shortage area or a population group
p.000305: described in subparagraph (B) of such sentence or a facility described in sub- paragraph (C) of such sentence, and has
p.000305: made a determination on the basis of the data and information submitted by such persons and groups and
p.000305: other data and information available to the Sec- retary.
p.000305: (2) For purposes of this subsection, the term ‘‘medical facility’’ means a facility for the delivery of
p.000305: health services and includes—
p.000305: (A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility,
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p.000483: engagement, workforce development, guidance and support for pro- grammatic efforts, and evaluation
p.000483: with respect to Alzheimer’s disease and related dementias, and in the case of a cooperative agreement under this
p.000483: section, how the applicant proposes to support other relevant activities identified by the Secretary or Director
p.000483: of the Centers for Disease Control and Prevention, as appropriate.
p.000483: (2) the manner in which the applicant will coordinate with Federal, tribal, and State programs related to Alzheimer’s
p.000483: dis- ease and related dementias, and appropriate State, tribal, and local agencies, as well as other relevant public
p.000483: and private or- ganizations or agencies; and
p.000483: (3) the manner in which the applicant will evaluate the ef- fectiveness of any program carried out under the
p.000483: cooperative agreement.
p.000483: (d) MATCHING REQUIREMENT.—Each health department that is awarded a cooperative agreement under subsection (a)
p.000483: shall pro- vide, from non-Federal sources, an amount equal to 30 percent of the amount provided under
p.000483: such agreement (which may be pro- vided in cash or in-kind) to carry out the activities supported by
p.000483: the cooperative agreement.
p.000483: (e) WAIVER AUTHORITY.—The Secretary may waive all or part of the matching requirement described in
p.000483: subsection (d) for any fis- cal year for a health department of a State, political subdivision of a State, or Indian
p.000483: tribe and tribal organization (including those lo- cated in a rural area or frontier area), if the Secretary determines
p.000483: that applying such matching requirement would result in serious hardship or an inability to carry out
p.000483: the purposes of the coopera- tive agreement awarded to such health department of a State, po- litical
p.000483: subdivision of a State, or Indian tribe and tribal organiza- tion.
p.000483: (g) RELATIONSHIP TO ITEMS AND SERVICES UNDER OTHER PRO- GRAMS.—A State may not make payments from a
p.000483: grant 92 under subsection (a) for any item or service to the extent that payment
p.000483:
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p.000483:
p.000483: January 30, 2020
p.000483: 92 Section 3(6) of Public Law 115–406 provides as follows: ‘‘(6) in subsection (f) (as so redesig- nated), by striking
p.000483: ‘grant’ and inserting ‘cooperative agreement’ ’’. The amendment was not car- ried out because it probably should have
p.000483: been made to subsection (g) (as so redesignated).
p.000483: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000483: Sec. 398A PUBLIC HEALTH SERVICE ACT 484
p.000483:
p.000483: has been made, or can reasonably be expected to be made, with re- spect to such item or service—
p.000483: (1) under any State compensation program, under an in- surance policy, or under any Federal or State
p.000483: health benefits program; or
p.000483: (2) by an entity that provides health services on a prepaid basis.
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p.000581: programs developed under section 501(a)(2) of the Social Security Act) in States that do not have such a
p.000581: program;
p.000581: (B) trainees under such training programs—
p.000581: (i) receive an appropriate balance of academic, clinical, and community opportunities;
p.000581: (ii) are culturally competent;
p.000581: (iii) are ethnically diverse;
p.000581: (iv) demonstrate a capacity to evaluate, diagnose or rule out, develop, and provide evidence-based inter-
p.000581: ventions to individuals with autism spectrum disorder and other developmental disabilities across their life-
p.000581: span; and
p.000581: (v) demonstrate an ability to use a family-centered approach, which may include collaborating with re- search
p.000581: centers or networks to provide training for pro- viders of respite care (as defined in section 2901); and
p.000581: (C) program sites provide culturally competent serv- ices.
p.000581: (2) DEVELOPMENTAL-BEHAVIORAL PEDIATRICIAN TRAINING PROGRAMS.—
p.000581: (A) IN GENERAL.—In making awards under this sub- section, the Secretary may prioritize awards to
p.000581: applicants that are developmental-behavioral pediatrician training programs located in rural or underserved
p.000581: areas.
p.000581: (B) DEFINITION OF UNDERSERVED AREA.—In this para- graph, the term ‘‘underserved area’’ means—
p.000581: (i) a health professional shortage area (as defined in section 332(a)(1)(A)); and
p.000581: (ii) an urban or rural area designated by the Sec- retary as an area with a shortage of personal health
p.000581: services (as described in section 330(b)(3)(A)).
p.000581: (3) TECHNICAL ASSISTANCE.—The Secretary may award one or more grants under this section to provide
p.000581: technical assist- ance to the network of interdisciplinary training programs.
p.000581: (4) BEST PRACTICES.—The Secretary shall promote re- search into additional valid and reliable tools
p.000581: for shortening the time required to confirm or rule out a diagnosis of autism spectrum disorder or other
p.000581: developmental disabilities and de- tecting individuals with autism spectrum disorder or other de- velopmental
p.000581: disabilities at an earlier age.
p.000581: (f) INTERVENTION.—The Secretary shall promote research, through grants or contracts, which may include grants
p.000581: or contracts to research centers or networks, to determine the evidence-based practices for interventions to
p.000581: improve the physical and behavioral
p.000581: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000583: PUBLIC HEALTH SERVICE ACT
p.000583: Sec. 399CC
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p.001079: (i) services relating to the identification, evalua- tion, and prevention of disease and disorders;
p.001079: (ii) dietary and nutrition services;
p.001079: (iii) health promotion services;
p.001079: (iv) rehabilitation services; or
p.001079: (v) health systems management services; and
p.001079: (C) who has not received a degree of doctor of medi- cine, a degree of doctor of osteopathy, a degree
p.001079: of doctor of dentistry or an equivalent degree, a degree of doctor of veterinary medicine or an
p.001079: equivalent degree, a degree of
p.001079: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001079:
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p.001081: 1081
p.001081: PUBLIC HEALTH SERVICE ACT
p.001081: Sec. 799B
p.001081:
p.001081: doctor of optometry or an equivalent degree, a degree of doctor of podiatric medicine or an equivalent degree,
p.001081: a de- gree of bachelor of science in pharmacy or an equivalent degree, a degree of doctor of pharmacy or an
p.001081: equivalent de- gree, a graduate degree in public health or an equivalent degree, a degree of doctor of
p.001081: chiropractic or an equivalent degree, a graduate degree in health administration or an equivalent degree,
p.001081: a doctoral degree in clinical psychology or an equivalent degree, or a degree in social work or an
p.001081: equivalent degree or a degree in counseling or an equiva- lent degree.
p.001081: (6) The term ‘‘medically underserved community’’ means an urban or rural area or population that—
p.001081: (A) is eligible for designation under section 332 as a health professional shortage area;
p.001081: (B) is eligible to be served by a migrant health center under section 329 25, a community health center under sec- tion
p.001081: 330 25, a grantee under section 330(h) (relating to homeless individuals), or a grantee under section
p.001081: 340A 25 (relating to residents of public housing);
p.001081: (C) has a shortage of personal health services, as de- termined under criteria issued by the Secretary under
p.001081: sec- tion 1861(aa)(2) of the Social Security Act (relating to rural health clinics); or
p.001081: (D) is designated by a State Governor (in consultation with the medical community) as a shortage area or medi-
p.001081: cally underserved community.
p.001081: (7) The term ‘‘Department’’ means the Department of Health and Human Services.
p.001081: (8) The term ‘‘nonprofit’’ refers to the status of an entity owned and operated by one or more
p.001081: corporations or associa- tions no part of the net earnings of which inures, or may law- fully inure, to the
p.001081: benefit of any private shareholder or indi- vidual.
p.001081: (9) The term ‘‘State’’ includes, in addition to the several States, only the District of Columbia, the
p.001081: Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Is- lands, the Virgin Islands, Guam,
p.001081: American Samoa, and the Trust Territory of the Pacific Islands.
p.001081: (10)(A) Subject to subparagraph (B), the term ‘‘underrep- resented minorities’’ means, with respect to a
...

p.001221:
p.001221:
p.001221:
p.001221:
p.001221:
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p.001221:
p.001221:
p.001221:
p.001221:
p.001221:
p.001221:
p.001221:
p.001221: January 30, 2020
p.001221: known to the health professional who provides health services to the member.
p.001221: (5) The term ‘‘individual practice association’’ means a partner- ship, corporation, association, or other legal
p.001221: entity which has en- tered into a services arrangement (or arrangements) with persons who are licensed to
p.001221: practice medicine, osteopathy, dentistry, podia- try, optometry, psychology, or other health profession in a
p.001221: State and a majority of whom are licensed to practice medicine or osteop- athy. Such an arrangement shall provide—
p.001221: (A) that such persons shall provide their professional serv- ices in accordance with a compensation arrangement
p.001221: estab- lished by the entity; and
p.001221: (B) to the extent feasible, for the sharing by such persons of medical and other records, equipment,
p.001221: and professional, technical, and administrative staff.
p.001221: (6) The term ‘‘health systems agency’’ means an entity which is designated in accordance with section 1515 of
p.001221: this Act.
p.001221: (7) The term ‘‘medically underserved population’’ means the population of an urban or rural area
p.001221: designated by the Secretary as an area with a shortage of personal health services or a popu- lation
p.001221: group designated by the Secretary as having a shortage of such services. Such a designation may be made
p.001221: by the Secretary only after consideration of the comments (if any) of (A) each State health planning and development
p.001221: agency which covers (in whole or in part) such urban or rural area or the area in which such popu- lation group
p.001221: resides, and (B) each health systems agency des- ignated for a health service area which covers (in whole or in
p.001221: part) such urban or rural area or the area in which such population group resides.
p.001221: (8)(A) The term ‘‘community rating system’’ means the sys- tems, described in subparagraphs (B) and (C),
p.001221: of fixing rates of payments for health services. A health maintenance organization may fix its rates of
p.001221: payments under the system described in sub- paragraph (B) or (C) or under both such systems, but a
p.001221: health maintenance organization may use only one such system for fixing its rates of payments for any one group.
p.001221: (B) A system of fixing rates of payment for health services may provide that the rates shall be fixed on a
p.001221: per-person or per-family basis and may authorize the rates to vary with the number of per- sons in a family, but,
p.001221: except as authorized in subparagraph (D), such rates must be equivalent for all individuals and for all
p.001221: fami- lies of similar composition.
p.001221: (C) A system of fixing rates of payment for health services may provide that the rates shall be fixed for individuals
p.001221: and families by groups. Except as authorized in subparagraph (D), such rates must be equivalent for all individuals in
p.001221: the same group and for all fami- lies of similar composition in the same group. If a health mainte- nance
p.001221: organization is to fix rates of payment for individuals and families by groups, it shall—
p.001221: (i)(I) classify all of the members of the organization into classes based on factors which the health
...

p.001259: assisted under an allotment or grant under this title, or (B) the term of repayment of a loan made or guar-
p.001259: anteed under this title in the case of a project assisted by a loan or loan guarantee.
p.001259: (11) The term ‘‘medical facility’’ means a hospital, public health center, outpatient medical facility,
p.001259: rehabilitation facil- ity, facility for long-term care, or other facility (as may be des- ignated by the Secretary)
p.001259: for the provision of health care to ambulatory patients.
p.001259: (12) The term ‘‘State Agency’’ means the State health plan- ning and development agency of a State designated under
p.001259: title XV.
p.001259: (13) The term ‘‘urban or rural poverty area’’ means an urban or rural geographical area (as defined by the
p.001259: Secretary) in which a percentage (as defined by the Secretary in accord- ance with the next sentence) of the
p.001259: residents of the area have incomes below the poverty level (as defined by the Secretary of Commerce). The percentage
p.001259: referred to in the preceding sen- tence shall be defined so that the percentage of the population of the United
p.001259: States residing in urban and rural poverty areas is—
p.001259: (A) not more than the percentage of the total popu- lation of the United States with incomes below the poverty
p.001259: level (as so defined) plus five per centum, and
p.001259: (B) not less than such percentage minus five per cen- tum.
p.001259: (14) The term ‘‘medically underserved population’’ means the population of an urban or rural area designated by
p.001259: the Sec- retary as an area with a shortage of health facilities or a popu- lation group designated by the Secretary as
p.001259: having a shortage of such facilities.
p.001259: FINANCIAL STATEMENTS; RECORDS AND AUDIT
p.001259: SEC. 1625. ø300s–4¿ (a) In the case of any facility for which an allotment payment, grant, loan, or
p.001259: loan guarantee has been made under this title, the applicant for such payment, grant, loan, or loan guarantee (or,
p.001259: if appropriate, such other person as the Sec- retary may prescribe) shall file at least annually with the
p.001259: State Agency for the State in which the facility is located a statement which shall be in such form,
p.001259: and contain such information, as the Secretary may require to accurately show—
p.001259: (1) the financial operations of the facility, and
p.001259:
p.001259:
p.001259:
p.001259: January 30, 2020
p.001259: 2 So in law. The comma probably should follow the ending quotations.
p.001259: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001259:
p.001259:
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p.001259:
p.001259:
p.001261: 1261
p.001261: PUBLIC HEALTH SERVICE ACT
p.001261: Sec. 1627
p.001261:
p.001261: (2) the costs to the facility of providing health services in the facility and the charges made by the
p.001261: facility for providing such services,
p.001261: during the period with respect to which the statement is filed. (b)(1) Each entity receiving Federal assistance under
p.001261: this title
...

General/Other / whistleblower

Searching for indicator whistleblower:

(return to top)
p.000635: the objectives are expected to be achieved, and justifications for revisions to the plan.
p.000635: (c) ADDITIONAL REPORTS.—In addition to reports required by subsections (a) and (b), the Director of NIH
p.000635: or the head of a na- tional research institute or national center may submit to the Con- gress such additional
p.000635: reports as the Director or the head of such institute or center determines to be appropriate.
p.000635: SEC. 403A. ø283a¿ ANNUAL REPORTING TO INCREASE INTERAGENCY COLLABORATION AND COORDINATION.
p.000635: (a) COLLABORATION WITH OTHER HHS AGENCIES.—On an an- nual basis, the Director of NIH shall submit to the
p.000635: Secretary a re- port on the activities of the National Institutes of Health involving collaboration with other agencies
p.000635: of the Department of Health and Human Services.
p.000635: (b) CLINICAL TRIALS.—Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a
p.000635: report that identifies each clinical trial that is registered during such calendar year in the databank of
p.000635: information established under section 402(i).
p.000635: (c) HUMAN TISSUE SAMPLES.—On an annual basis, the Director of NIH shall submit to the Congress a report
p.000635: that describes how the National Institutes of Health and its agencies store and track human tissue samples.
p.000635: (d) FIRST REPORT.—The first report under subsections (a), (b), and (c) shall be submitted not later than
p.000635: 1 year after the date of the enactment of the National Institutes of Health Reform Act of 2006.
p.000635: SEC. 403B. ø283a–1¿ ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.
p.000635: (a) WHISTLEBLOWER COMPLAINTS.—
p.000635: (1) IN GENERAL.—On an annual basis, the Director of NIH shall submit to the Inspector General of the Department
p.000635: of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on
p.000635: Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the
p.000635: Committee on Appro- priations of the Senate a report summarizing the activities of the National Institutes
p.000635: of Health relating to whistleblower complaints.
p.000635: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000635:
p.000635:
p.000635:
p.000635:
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p.000635:
p.000635:
p.000637: 637
p.000637: PUBLIC HEALTH SERVICE ACT
p.000637: Sec. 403D
p.000637:
p.000637: (2) CONTENTS.—For each whistleblower complaint pending during the year for which a report is submitted under this sub-
p.000637: section, the report shall identify the following:
p.000637: (A) Each agency of the National Institutes of Health involved.
p.000637: (B) The status of the complaint.
p.000637: (C) The resolution of the complaint to date.
p.000637: (b) FIRST REPORT.—The first report under subsection (a) shall be submitted not later than 1 year after the date
p.000637: of the enactment of the National Institutes of Health Reform Act of 2006.
p.000637: SEC. 403C. ø283a–2¿ ANNUAL REPORTING REGARDING TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES.
p.000637: (a) IN GENERAL.—Each institution receiving an award under this title for the training of graduate students for
p.000637: doctoral degrees shall annually report to the Director of NIH, with respect to grad- uate students supported by the
p.000637: National Institutes of Health at such institution—
p.000637: (1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
p.000637: (2) for students described in paragraph (1), the average time between the beginning of graduate study
p.000637: and the receipt of a doctoral degree.
p.000637: (3) 5 PROVISION OF INFORMATION TO APPLICANTS.—Each in- stitution described in subsection (a) shall provide
p.000637: to each stu- dent submitting an application for a program of graduate study at such institution the information
p.000637: described in paragraphs (1) and (2) of such subsection with respect to the program or pro- grams to which such student
p.000637: has applied.
p.000637: DES
p.000637: SEC. 403D. ø283a–3¿ (a) The Director of NIH shall establish a program for the conduct and support of research and
...

Orphaned Trigger Words

p.000001: (I) the individual who allegedly transmitted the vaccinia, if vaccinia vaccine was administered to such individual
p.000001: as provided by paragraph (2)(B) and such individual was within a category of indi- viduals covered by a declaration
p.000001: under paragraph (2)(A)(i); or
p.000001: (II) an entity that employs an individual de- scribed by clause (I) or where such individual has privileges or
p.000001: is otherwise authorized to provide health care;
p.000001: (vi) an official, agent, or employee of a person de- scribed in clause (i), (ii), (iii), or (iv);
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 12 Indentation is so in law. See section 3(e) of Public Law 108–20 (117 Stat. 647).
p.000001: 13 Clause (ii) is shown according to the probable intent of the Congress. In amending the clause to
p.000001: create a subclause (I), section 3(f)(2)(B) of Public Law 108–20 (117 Stat. 647) provided that the clause is amended by
p.000001: redesignating certain words ‘‘as clause (I) and indenting accord- ingly’’. The reference in the amendatory instructions
p.000001: to ‘‘clause (I)’’ probably should be to ‘‘sub- clause (I)’’, and the use in the instructions of the word
p.000001: ‘‘accordingly’’ requires the exercise of editorial judgment.
p.000001: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000001:
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001:
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p.000001:
p.000001: 41 PUBLIC HEALTH SERVICE ACT Sec. 224
p.000001:
p.000001: (vii) a contractor of, or a volunteer working for, a person described in clause (i), (ii), or (iv), if
p.000001: the con- tractor or volunteer performs a function for which a person described in clause (i), (ii), or
p.000001: (iv) is a covered person; or
p.000001: (viii) an individual who has privileges or is other- wise authorized to provide health care under the aus- pices of an
p.000001: entity described in clause (ii) or (v)(II).
p.000001: (C) QUALIFIED PERSON.—The term ‘‘qualified person’’, when used with respect to the administration of a covered
p.000001: countermeasure, means a licensed health professional or other individual who 14—
p.000001: (i) is authorized to administer such counter- measure under the law of the State in which the coun-
p.000001: termeasure was administered; or
p.000001: (ii) is otherwise authorized by the Secretary to ad- minister such countermeasure.
p.000001: (D) ARISING OUT OF ADMINISTRATION OF A COVERED COUNTERMEASURE.—The term ‘‘arising out of administra-
p.000001: tion of a covered countermeasure’’, when used with respect to a claim or liability, includes a claim or
p.000001: liability arising out of—
p.000001: (i) determining whether, or under what conditions, an individual should receive a covered counter- measure;
p.000001: (ii) obtaining informed consent of an individual to the administration of a covered countermeasure;
p.000001: (iii) monitoring, management, or care of an imme- diate site of administration on the body of a covered
p.000001: countermeasure, or evaluation of whether the adminis- tration of the countermeasure has been effective; or
p.000001: (iv) transmission of vaccinia virus by an indi- vidual to whom vaccinia vaccine was administered
p.000001: as provided by paragraph (2)(B).
p.000001: (q)(1) For purposes of this section, a health professional volun- teer at a deemed entity described in subsection
p.000001: (g)(4) shall, in pro- viding a health professional service eligible for funding under sec- tion 330 to an
p.000001: individual, be deemed to be an employee of the Pub- lic Health Service for a calendar year that begins during
p.000001: a fiscal year for which a transfer was made under paragraph (4)(C). The preceding sentence is subject to
p.000001: the provisions of this subsection.
p.000001: (2) In providing a health service to an individual, a health care practitioner shall for purposes of this
p.000001: subsection be considered to be a health professional volunteer at an entity described in sub- section
p.000001: (g)(4) if the following conditions are met:
p.000001: (A) The service is provided to the individual at the facili- ties of an entity described in subsection
p.000001: (g)(4), or through off- site programs or events carried out by the entity.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: January 30, 2020
p.000001: 14 Subparagraph (C) is shown according to the probable intent of the Congress. In amending the ...

p.000017: in such amounts as are provided in ad- vance in Appropriation Acts.
p.000017: (c) The Secretary may conduct biomedical research, directly or through grants or contracts, for the
p.000017: identification, control, treat- ment, and prevention of diseases (including tropical diseases) which do
p.000017: not occur to a significant extent in the United States.
p.000017: (d)(1)(A) If a person is engaged in biomedical, behavioral, clin- ical, or other research, in which identifiable,
p.000017: sensitive information is collected (including research on mental health and research on the use and effect
p.000017: of alcohol and other psychoactive drugs), the Sec- retary, in coordination with other agencies, as applicable—
p.000017: (i) shall issue to such person a certificate of confidentiality to protect the privacy of individuals who are
p.000017: the subjects of such research if the research is funded wholly or in part by the Federal Government; and
p.000017: (ii) may, upon application by a person engaged in research, issue to such person a certificate of
p.000017: confidentiality to protect the privacy of such individuals if the research is not so funded.
p.000017: (B) Except as provided in subparagraph (C), any person to whom a certificate is issued under subparagraph (A)
p.000017: to protect the privacy of individuals described in such subparagraph shall not dis- close or provide to any other
p.000017: person not connected with the re- search the name of such an individual or any information, docu- ment,
p.000017: or biospecimen that contains identifiable, sensitive informa- tion about such an individual and that was created
p.000017: or compiled for purposes of the research.
p.000017: (C) The disclosure prohibition in subparagraph (B) shall not apply to disclosure or use that is—
p.000017: (i) required by Federal, State, or local laws, excluding in- stances described in subparagraph (D);
p.000017: (ii) necessary for the medical treatment of the individual to whom the information, document, or
p.000017: biospecimen pertains and made with the consent of such individual;
p.000017: (iii) made with the consent of the individual to whom the information, document, or biospecimen pertains; or
p.000017: (iv) made for the purposes of other scientific research that is in compliance with applicable Federal regulations
p.000017: governing the protection of human subjects in research.
p.000017: (D) Any person to whom a certificate is issued under subpara- graph (A) to protect the privacy of an individual
p.000017: described in such subparagraph shall not, in any Federal, State, or local civil, crimi- nal, administrative,
p.000017: legislative, or other proceeding, disclose or pro-
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
p.000017:
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p.000017:
p.000017: Sec. 301 PUBLIC HEALTH SERVICE ACT 76
p.000017:
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p.000017: January 30, 2020
p.000017:
p.000017: vide the name of such individual or any such information, docu- ment, or biospecimen that contains
p.000017: identifiable, sensitive informa- tion about the individual and that was created or compiled for pur- poses of the
p.000017: research, except in the circumstance described in sub- paragraph (C)(iii).
p.000017: (E) Identifiable, sensitive information protected under subpara- graph (A), and all copies thereof, shall be ...

p.000017: in such activities of statistics collected or compiled by the Center.
p.000017: (j) In carrying out the requirements of section 304(c) and para- graph (1) of subsection (e) of this section,
p.000017: the Secretary shall co- ordinate health statistical and epidemiological activities of the De- partment of Health and
p.000017: Human Services by—
p.000017:
p.000017:
p.000017:
p.000017: January 30, 2020
p.000017: 4 So in law. Probably should be capitalized.
p.000017: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000017:
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p.000017:
p.000017:
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p.000017:
p.000017: Sec. 306 PUBLIC HEALTH SERVICE ACT 82
p.000017:
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p.000017:
p.000017: January 30, 2020
p.000017:
p.000017: (1) establishing standardized means for the collection of health information and statistics under laws
p.000017: administered by the Secretary;
p.000017: (2) developing, in consultation with the National Com- mittee on Vital and Health Statistics, and
p.000017: maintaining the minimum sets of data needed on a continuing basis to fulfill the collection requirements of
p.000017: subsection (b)(1);
p.000017: (3) after consultation with the National Committee on Vital and Health Statistics, establishing standards
p.000017: to assure the quality of health statistical and epidemiological data collec- tion, processing, and analysis;
p.000017: (4) in the case of proposed health data collections of the Department which are required to be reviewed by
p.000017: the Director of the Office of Management and Budget under section 3509 of title 44, United States Code, reviewing
p.000017: such proposed collec- tions to determine whether they conform with the minimum sets of data and the standards
p.000017: promulgated pursuant to para- graphs (2) and (3), and if any such proposed collection is found not to be in
p.000017: conformance, by taking such action as may be nec- essary to assure that it will conform to such sets of data
p.000017: and standards, and
p.000017: (5) periodically reviewing ongoing health data collections of the Department, subject to review under such section
p.000017: 3509, to determine if the collections are being conducted in accordance with the minimum sets of data and the
p.000017: standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be
p.000017: in conformance, by taking such action as may be necessary to assure that the collection will conform to
p.000017: such sets of data and standards not later than the nineteenth day after the date of the completion of the review of the
p.000017: collec- tion. ...

p.000239: the Federal Government to meet identified strategic needs.
p.000239: (iii) NOT AGENCY.—An entity that enters into an agreement under clause (i) shall not be deemed to be a
p.000239: Federal agency for any purpose, including for any purpose under title 5, United States Code.
p.000239: (iv) DIRECTION.—Pursuant to an agreement en- tered into under this subparagraph, the Secretary, act- ing through
p.000239: the Director of BARDA, shall provide di- rection to the entity that enters into an agreement under
p.000239: clause (i). As part of this agreement the Direc- tor of BARDA shall—
p.000239: (I) communicate the medical countermeasure needs, requirements, and problems to be ad- dressed by the
p.000239: entity under the agreement;
p.000239: (II) develop a description of work to be per- formed by the entity under the agreement;
p.000239: (III) provide technical feedback and appro- priate oversight over work carried out by the enti- ty under the
p.000239: agreement, including subsequent de- velopment and partnerships consistent with the needs and requirements set
p.000239: forth in this subpara- graph;
p.000239: (IV) ensure fair consideration of products de- veloped under the agreement in order to maintain competition to
p.000239: the maximum practical extent, as applicable and appropriate under applicable provi- sions of this section; and
p.000239: (V) ensure, as a condition of the agreement that the entity—
p.000239: (aa) has in place a comprehensive set of policies that demonstrate a commitment to transparency and
p.000239: accountability;
p.000239: (bb) protects against conflicts of interest through a comprehensive set of policies that address potential
p.000239: conflicts of interest, ethics, disclosure, and reporting requirements;
p.000239: (cc) provides monthly accounting on the use of funds provided under such agreement; and
p.000239:
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p.000239: (dd) provides on a quarterly basis, reports regarding the progress made toward meeting the identified needs set
p.000239: forth in the agree- ment.
p.000239: (v) SUPPLEMENT NOT SUPPLANT.—Activities carried out under this subparagraph shall supplement, and
p.000239: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000241: PUBLIC HEALTH SERVICE ACT
p.000241: Sec. 319L
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p.000241: not supplant, other activities carried out under this section.
p.000241: (vi) NO ESTABLISHMENT OF ENTITY.—To prevent unnecessary duplication and target resources effec- ...

p.000269: under title XIX of such Act, or to assistance for medical expenses under any other pub- lic assistance program
p.000269: or private health insurance pro- gram;
p.000269: (G) the center—
p.000269: (i) has prepared a schedule of fees or payments for the provision of its services consistent with locally pre- vailing
p.000269: rates or charges and designed to cover its rea- sonable costs of operation and has prepared a cor- responding
p.000269: schedule of discounts to be applied to the payment of such fees or payments, which discounts are
p.000269: adjusted on the basis of the patient’s ability to pay;
p.000269: (ii) has made and will continue to make every rea- sonable effort—
p.000269: (I) to secure from patients payment for serv- ices in accordance with such schedules; and
p.000269: (II) to collect reimbursement for health serv- ices to persons described in subparagraph (F) on the basis
p.000269: of the full amount of fees and payments for such services without application of any dis- count;
p.000269: (iii)(I) will assure that no patient will be denied health care services due to an individual’s inability to
p.000269: pay for such services; and
p.000269: (II) will assure that any fees or payments required by the center for such services will be reduced or waived
p.000269: to enable the center to fulfill the assurance de- scribed in subclause (I); and
p.000269: (iv) has submitted to the Secretary such reports as the Secretary may require to determine compliance with this
p.000269: subparagraph;
p.000269: (H) the center has established a governing board which except in the case of an entity operated
p.000269: by an In- dian tribe or tribal or Indian organization under the In- dian Self-Determination Act or an
p.000269: urban Indian organiza- tion under the Indian Health Care Improvement Act (25
p.000269: U.S.C. 1651 et seq.)—
p.000269:
p.000269:
p.000269:
p.000269: January 30, 2020
p.000269: 32 Indentation is so in law. See section 101(7)(A)(i)(III) of Public Law 107–251 (116 Stat. 225).
p.000269: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000271: PUBLIC HEALTH SERVICE ACT
p.000271: Sec. 330
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p.000271: (i) is composed of individuals, a majority of whom are being served by the center and who, as a group,
p.000271: represent the individuals being served by the center;
p.000271: (ii) meets at least once a month, selects the serv- ices to be provided by the center, schedules the hours
p.000271: during which such services will be provided, approves the center’s annual budget, approves the selection of a ...

p.000281: Congress not later than January 1, 2000, and a final report is required to be submitted not later than January 1, 2007.
p.000281: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000281:
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p.000281: Sec. 330C PUBLIC HEALTH SERVICE ACT 282
p.000281:
p.000281: (A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under
p.000281: paragraph (1) for each such fiscal years);
p.000281: (B) $100,000,000 for fiscal year 2003;
p.000281: (C) $150,000,000 for each of fiscal years 2004 through 2017; and
p.000281: (D) $150,000,000 for each of fiscal years 2018 and 2019, and $96,575,342 for the period beginning on October 1,
p.000281: 2019, and ending on May 22, 2020, to remain available until expended.
p.000281: SEC. 330C. ø254c–3¿ SPECIAL DIABETES PROGRAMS FOR INDIANS. 34
p.000281: (a) IN GENERAL.—The Secretary shall make grants for pro- viding services for the prevention and treatment of
p.000281: diabetes in ac- cordance with subsection (b).
p.000281: (b) SERVICES THROUGH INDIAN HEALTH FACILITIES.—For pur- poses of subsection (a), services under such subsection
p.000281: are provided in accordance with this subsection if the services are provided through any of the following
p.000281: entities:
p.000281: (1) The Indian Health Service.
p.000281: (2) An Indian health program operated by an Indian tribe or tribal organization pursuant to a contract, grant,
p.000281: cooperative agreement, or compact with the Indian Health Service pursu- ant to the Indian Self-Determination
p.000281: Act.
p.000281: (3) An urban Indian health program operated by an urban Indian organization pursuant to a grant or contract
p.000281: with the Indian Health Service pursuant to title V of the Indian Health Care Improvement Act.
p.000281: (c) FUNDING.—
p.000281: (1) TRANSFERRED FUNDS.—Notwithstanding section 2104(a) of the Social Security Act, from the amounts
p.000281: appropriated in such section for each of fiscal years 1998 through 2002,
p.000281: $30,000,000, to remain available until expended, is hereby transferred and made available in such fiscal
p.000281: year for grants under this section.
p.000281: (2) APPROPRIATIONS.—For the purpose of making grants under this section, there is appropriated, out of
p.000281: any money in the Treasury not otherwise appropriated—
p.000281: (A) $70,000,000 for each of fiscal years 2001 and 2002 (which shall be combined with amounts transferred under
p.000281: paragraph (1) for each such fiscal years);
p.000281: (B) $100,000,000 for fiscal year 2003;
p.000281: (C) $150,000,000 for each of fiscal years 2004 through 2017; and
p.000281: (D) $150,000,000 for each of fiscal years 2018 and 2019, and $96,575,342 for the period beginning on October 1,
p.000281: 2019, and ending on May 22, 2020, to remain available until expended.
p.000281: SEC. 330D. ø254c–4¿ CENTERS FOR STRATEGIES ON FACILITATING UTI- LIZATION OF PREVENTIVE HEALTH SERVICES AMONG
p.000281: VARIOUS POPULATIONS.
p.000281: (a) IN GENERAL.—The Secretary, acting through the appro- priate agencies of the Public Health Service,
p.000281: shall make grants to
p.000281:
p.000281:
p.000281:
p.000281: January 30, 2020
p.000281: 34 See footnote to section 330B.
p.000281:
p.000281: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000281:
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p.000375: and indirect payment amounts under subsection (a).
p.000375: (5) REPORTING.—A hospital receiving payments under this subsection shall be subject to the reporting requirements under
p.000375: subsection (b)(3).
p.000375: (6) REMAINING FUNDS.—
p.000375: (A) IN GENERAL.—If the payments to qualified hos- pitals under paragraph (1) for a fiscal year are less
p.000375: than the total amount made available under such paragraph for that fiscal year, any remaining amounts for such
p.000375: fiscal year may be made available to all hospitals participating in the program under this subsection or
p.000375: subsection (a).
p.000375: (B) QUALITY BONUS SYSTEM.—For purposes of distrib- uting the remaining amounts described in subparagraph
p.000375: (A), the Secretary may establish a quality bonus system, whereby the Secretary distributes bonus payments to
p.000375: hos- pitals participating in the program under this subsection or subsection (a) that meet standards specified
p.000375: by the Sec- retary, which may include a focus on quality measurement and improvement, interpersonal and
p.000375: communications skills, delivering patient-centered care, and practicing in
p.000375: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000377: PUBLIC HEALTH SERVICE ACT
p.000377: Sec. 340G
p.000377:
p.000377: integrated health systems, including training in commu- nity-based settings. In developing such standards, the
p.000377: Sec- retary shall collaborate with relevant stakeholders, includ- ing program accrediting bodies, certifying
p.000377: boards, training programs, health care organizations, health care pur- chasers, and patient and consumer
p.000377: groups.
p.000377: Subpart X—Primary Dental Programs
p.000377:
p.000377: SEC. 340F. ø256f¿ DESIGNATED DENTAL HEALTH PROFESSIONAL SHORTAGE AREA.
p.000377: In this subpart, the term ‘‘designated dental health profes- sional shortage area’’ means an area,
p.000377: population group, or facility that is designated by the Secretary as a dental health professional shortage area
p.000377: under section 332 or designated by the applicable State as having a dental health professional shortage.
p.000377: SEC. 340G. ø256g¿ GRANTS FOR INNOVATIVE PROGRAMS.
p.000377: (a) GRANT PROGRAM AUTHORIZED.—The Secretary, acting through the Administrator of the Health Resources
p.000377: and Services Administration, is authorized to award grants to States for the pur- pose of helping States develop and
p.000377: implement innovative programs to address the dental workforce needs of designated dental health professional
p.000377: shortage areas in a manner that is appropriate to the States’ individual needs.
p.000377: (b) STATE ACTIVITIES.—A State receiving a grant under sub- section (a) may use funds received under the grant
p.000377: for—
p.000377: (1) loan forgiveness and repayment programs for dentists who—
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p.000395: January 30, 2020
p.000395:
p.000395: (F) EFFECT OF INFRINGEMENT ACTION.—In the event that the reference product sponsor files a patent
p.000395: infringe- ment suit, the use of confidential information shall con- tinue to be governed by the terms of
p.000395: this paragraph until such time as a court enters a protective order regarding the information. Upon
p.000395: entry of such order, the subsection
p.000395: (k) applicant may redesignate confidential information in accordance with the terms of that order. No
p.000395: confidential information shall be included in any publicly-available complaint or other pleading. In
p.000395: the event that the ref- erence product sponsor does not file an infringement action by the date specified in
p.000395: paragraph (6), the reference prod- uct sponsor shall return or destroy all confidential infor- mation received
p.000395: under this paragraph, provided that if the reference product sponsor opts to destroy such information, it will
p.000395: confirm destruction in writing to the subsection (k) applicant.
p.000395: (G) RULE OF CONSTRUCTION.—Nothing in this para- graph shall be construed—
p.000395: (i) as an admission by the subsection (k) applicant regarding the validity, enforceability, or infringement of any
p.000395: patent; or
p.000395: (ii) as an agreement or admission by the sub- section (k) applicant with respect to the competency,
p.000395: relevance, or materiality of any confidential informa- tion.
p.000395: (H) EFFECT OF VIOLATION.—The disclosure of any con- fidential information in violation of this paragraph shall be
p.000395: deemed to cause the subsection (k) applicant to suffer ir- reparable harm for which there is no
p.000395: adequate legal rem- edy and the court shall consider immediate injunctive re- lief to be an appropriate and
p.000395: necessary remedy for any vio- lation or threatened violation of this paragraph.
p.000395: (2) SUBSECTION (k) APPLICATION INFORMATION.—Not later than 20 days after the Secretary notifies the subsection (k)
p.000395: ap- plicant that the application has been accepted for review, the subsection (k) applicant—
p.000395: (A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary
p.000395: under subsection (k), and such other information that describes the process or processes used to manufacture the
p.000395: biological product that is the subject of such application; and
p.000395: (B) may provide to the reference product sponsor addi- tional information requested by or on behalf of the
p.000395: ref- erence product sponsor.
p.000395: (3) LIST AND DESCRIPTION OF PATENTS.—
p.000395: (A) LIST BY REFERENCE PRODUCT SPONSOR.—Not later than 60 days after the receipt of the application and infor-
p.000395: mation under paragraph (2), the reference product sponsor shall provide to the subsection (k) applicant—
p.000395: (i) a list of patents for which the reference product sponsor believes a claim of patent infringement could
p.000395: reasonably be asserted by the reference product spon- sor, or by a patent owner that has granted an
p.000395: exclu-
p.000395: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000433: PUBLIC HEALTH SERVICE ACT
p.000433: Sec. 354
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p.000433: (iv) Facilities that are selected for inclusion in the program shall be inspected at such intervals as the
p.000433: Secretary determines will reasonably ensure that the facilities are maintaining compliance with such stand- ards.
p.000433: (h) SANCTIONS.—
p.000433: (1) IN GENERAL.—In order to promote voluntary compliance with this section, the Secretary may, in lieu of
p.000433: taking the ac- tions authorized by subsection (i), impose one or more of the following sanctions:
p.000433: (A) Directed plans of correction which afford a facility an opportunity to correct violations in a timely manner.
p.000433: (B) Payment for the cost of onsite monitoring.
p.000433: (2) PATIENT INFORMATION.—If the Secretary determines that the quality of mammography performed by a
p.000433: facility (whether or not certified pursuant to subsection (c)) was so in- consistent with the quality standards
p.000433: established pursuant to subsection (f) as to present a significant risk to individual or public health, the
p.000433: Secretary may require such facility to notify patients who received mammograms at such facility, and their referring
p.000433: physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial
p.000433: measures, and such other relevant information as the Secretary may re- quire.
p.000433: (3) CIVIL MONEY PENALTIES.—The Secretary may assess civil money penalties in an amount not to exceed $10,000
p.000433: for—
p.000433: (A) failure to obtain a certificate as required by sub- section (b),
p.000433: (B) each failure by a facility to substantially comply with, or each day on which a facility fails to
p.000433: substantially comply with, the standards established under subsection
p.000433: (f) or the requirements described in subclauses (I) through
p.000433: (III) of subsection (d)(1)(B)(ii),
p.000433: (C) each failure to notify a patient of risk as required by the Secretary pursuant to paragraph (2), and
p.000433: (D) each violation, or for each aiding and abetting in a violation of, any provision of, or regulation
p.000433: promulgated under, this section by an owner, operator, or any employee of a facility required to have a certificate.
p.000433: (4) PROCEDURES.—The Secretary shall develop and imple- ment procedures with respect to when and how each
p.000433: of the sanctions is to be imposed under paragraphs (1) through (3). Such procedures shall provide for
p.000433: notice to the owner or oper- ator of the facility and a reasonable opportunity for the owner or operator to
p.000433: respond to the proposed sanctions and appro- priate procedures for appealing determinations relating to
p.000433: the imposition of sanctions.
p.000433: (i) SUSPENSION AND REVOCATION.—
p.000433: (1) IN GENERAL.—The certificate of a facility issued under subsection (c) may be suspended or revoked if
p.000433: the Secretary finds, after providing, except as provided in paragraph (2), rea- sonable notice and an opportunity
p.000433: for a hearing to the owner or operator of the facility, that the owner, operator, or any em- ployee of the
p.000433: facility—
p.000433: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000433: subsection (g);
p.000433: (E) has violated or aided and abetted in the violation of any provision of, or regulation promulgated
p.000433: under, this section; or
p.000433: (F) has failed to comply with a sanction imposed under subsection (h).
p.000433: (2) ACTION BEFORE A HEARING.—
p.000433: (A) IN GENERAL.—The Secretary may suspend the cer- tificate of the facility before holding a hearing required by
p.000433: paragraph (1) if the Secretary has reason to believe that the circumstance of the case will support one
p.000433: or more of the findings described in paragraph (1) and that—
p.000433: (i) the failure or violation was intentional; or
p.000433: (ii) the failure or violation presents a serious risk to human health.
p.000433: (B) HEARING.—If the Secretary suspends a certificate under subparagraph (A), the Secretary shall provide an op-
p.000433: portunity for a hearing to the owner or operator of the fa- cility not later than 60 days from the effective date of
p.000433: the suspension. The suspension shall remain in effect until the decision of the Secretary made after the hearing.
p.000433: (3) INELIGIBILITY TO OWN OR OPERATE FACILITIES AFTER REVOCATION.—If the Secretary revokes the certificate
p.000433: of a facil- ity on the basis of an act described in paragraph (1), no person who owned or operated the facility at the
p.000433: time of the act may, within 2 years of the revocation of the certificate, own or oper- ate a facility that requires a
p.000433: certificate under this section.
p.000433: (j) INJUNCTIONS.—If the Secretary determines that—
p.000433: (1) continuation of any activity related to the provision of mammography by a facility would constitute
p.000433: a serious risk to human health, the Secretary may bring suit in the district court of the United States for
p.000433: the district in which the facility is situated to enjoin continuation of the activity; and
p.000433: (2) a facility is operating without a certificate as required by subsection (b), the Secretary may bring
p.000433: suit in the district
p.000433: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000435: PUBLIC HEALTH SERVICE ACT
p.000435: Sec. 354
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p.000435: court of the United States for the district in which the facility is situated to enjoin the operation of the facility.
p.000435: Upon a proper showing, the district court shall grant a temporary injunction or restraining order against
p.000435: continuation of the activity or against operation of a facility, as the case may be, without re- ...

p.000455: SEC. 377D. ø274f–4¿ REPORT RELATING TO ORGAN DONATION AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF ORGANS.
p.000455: (a) IN GENERAL.—Not later than December 31, 2005, and every
p.000455: 2 years thereafter, the Secretary shall report to the appropriate committees of Congress on the activities of
p.000455: the Department carried out pursuant to this part, including an evaluation describing the extent to which the
p.000455: activities have affected the rate of organ dona- tion and recovery.
p.000455: (b) REQUIREMENTS.—To the extent practicable, each report sub- mitted under subsection (a) shall—
p.000455: (1) evaluate the effectiveness of activities, identify effective activities, and disseminate such findings with respect
p.000455: to organ donation and recovery;
p.000455: (2) assess organ donation and recovery activities that are recently completed, ongoing, or planned; and
p.000455: (3) evaluate progress on the implementation of the plan re- quired under subsection (c)(5).
p.000455: (c) INITIAL REPORT REQUIREMENTS.—The initial report under subsection (a) shall include the following:
p.000455: (1) An evaluation of the organ donation practices of organ procurement organizations, States, other countries, and
p.000455: other appropriate organizations including an examination across all populations, including those with low
p.000455: organ donation rates, of—
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p.000455: (A) existing barriers to organ donation; and
p.000455: (B) the most effective donation and recovery practices.
p.000455: (2) An evaluation of living donation practices and proce- dures. Such evaluation shall include an
p.000455: assessment of issues relating to informed consent and the health risks associated with living donation
p.000455: (including possible reduction of long-term effects).
p.000455: (3) An evaluation of—
p.000455: (A) federally supported or conducted organ donation efforts and policies, as well as federally supported
p.000455: or con-
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p.000457: PUBLIC HEALTH SERVICE ACT
p.000457: Sec. 377E
p.000457:
p.000457: ducted basic, clinical, and health services research (includ- ing research on preservation techniques and organ
p.000457: rejec- tion and compatibility); and
p.000457: (B) the coordination of such efforts across relevant agencies within the Department and throughout the
p.000457: Fed- eral Government.
p.000457: (4) An evaluation of the costs and benefits of State donor registries, including the status of existing
p.000457: State donor reg- istries, the effect of State donor registries on organ donation rates, issues relating to
p.000457: consent, and recommendations regard- ing improving the effectiveness of State donor registries in in- creasing overall
p.000457: organ donation rates.
p.000457: (5) A plan to improve federally supported or conducted organ donation and recovery activities, including, when
p.000457: appro- priate, the establishment of baselines and benchmarks to measure overall outcomes of these ...

p.000511: (1) IN GENERAL.—This section may not be construed to act as a replacement for or diminishment of the program
p.000511: carried out by the Director of the National Cancer Institute and des- ignated by such Director as the
p.000511: Surveillance, Epidemiology, and End Results Program (SEER).
p.000511: (2) SUPPLANTING OF ACTIVITIES.—In areas where both such programs exist, the Secretary shall ensure that SEER support is
p.000511: not supplanted and that any additional activities are con- sistent with the guidelines provided for in
p.000511: subsection (c)(2) (C) and (D) and are appropriately coordinated with the existing SEER program.
p.000511: (3) TRANSFER OF RESPONSIBILITY.—The Secretary may not transfer administration responsibility for such SEER
p.000511: program from such Director.
p.000511: (4) COORDINATION.—To encourage the greatest possible ef- ficiency and effectiveness of Federally supported
p.000511: efforts with respect to the activities described in this subsection, the Sec- retary shall take steps to
p.000511: assure the appropriate coordination of programs supported under this part with existing Federally supported cancer
p.000511: registry programs.
p.000511: (e) REQUIREMENT REGARDING CERTAIN STUDY ON BREAST CAN- CER.—In the case of a grant under subsection (a) to any
p.000511: State spec- ified in subsection (b) of section 399E, the Secretary may establish such conditions regarding the receipt
p.000511: of the grant as the Secretary determines are necessary to facilitate the collection of data for the study carried out
p.000511: under such section.
p.000511: SEC. 399C. ø280e–1¿ PLANNING GRANTS REGARDING REGISTRIES.
p.000511: (a) IN GENERAL.—
p.000511: (1) STATES.—The Secretary, acting through the Director of the Centers for Disease Control, may make grants to States
p.000511: for the purpose of developing plans that meet the assurances re- quired by the Secretary under section
p.000511: 399B(c)(2).
p.000511: (2) OTHER ENTITIES.—For the purpose described in para- graph (1), the Secretary may make grants to
p.000511: public entities other than States and to nonprofit private entities. Such a grant may be made to an entity
p.000511: only if the State in which the purpose is to be carried out has certified that the State ap- proves the
p.000511: entity as qualified to carry out the purpose.
p.000511: (b) APPLICATION.—The Secretary may make a grant under sub- section (a) only if an application for the grant is
p.000511: submitted to the Secretary, the application contains the certification required in sub- section (a)(2) (if the
p.000511: application is for a grant under such sub- section), and the application is in such form, is made in such man-
p.000511: ner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out
p.000511: this section.
p.000511: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000511: Sec. 399D PUBLIC HEALTH SERVICE ACT 512
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p.000559: (2) submit to the Secretary an application at such time, in such manner, and containing such information as the
p.000559: Sec- retary may require.
p.000559: (g) AUTHORIZATION OF APPROPRIATIONS.—To carry out this sec- tion, there are authorized to be appropriated
p.000559: $10,000,000 for each of fiscal years 2020 through 2024.
p.000559: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000561: PUBLIC HEALTH SERVICE ACT
p.000561: Sec. 399V–4
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p.000561: SEC. 399V–3. ø280g–14¿ NATIONAL DIABETES PREVENTION PROGRAM.
p.000561: (a) IN GENERAL.—The Secretary, acting through the Director of the Centers for Disease Control and Prevention,
p.000561: shall establish a national diabetes prevention program (referred to in this section as the ‘‘program’’) targeted at
p.000561: adults at high risk for diabetes in order to eliminate the preventable burden of diabetes.
p.000561: (b) PROGRAM ACTIVITIES.—The program described in subsection
p.000561: (a) shall include—
p.000561: (1) a grant program for community-based diabetes preven- tion program model sites;
p.000561: (2) a program within the Centers for Disease Control and Prevention to determine eligibility of entities to
p.000561: deliver commu- nity-based diabetes prevention services;
p.000561: (3) a training and outreach program for lifestyle interven- tion instructors; and
p.000561: (4) evaluation, monitoring and technical assistance, and applied research carried out by the Centers for Disease
p.000561: Control and Prevention.
p.000561: (c) ELIGIBLE ENTITIES.—To be eligible for a grant under sub- section (b)(1), an entity shall be a State or
p.000561: local health department, a tribal organization, a national network of community-based non- profits focused on health
p.000561: and wellbeing, an academic institution, or other entity, as the Secretary determines.
p.000561: (d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of carrying out this section, there are authorized
p.000561: to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.
p.000561: SEC. 399V–4. ø280g–15¿ STATE DEMONSTRATION PROGRAMS TO EVALU- ATE ALTERNATIVES TO CURRENT MEDICAL TORT LITIGA- TION.
p.000561: (a) IN GENERAL.—The Secretary is authorized to award dem- onstration grants to States for the
p.000561: development, implementation, and evaluation of alternatives to current tort litigation for resolving disputes over
p.000561: injuries allegedly caused by health care providers or health care organizations. In awarding such grants,
p.000561: the Secretary shall ensure the diversity of the alternatives so funded. ...

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p.000589: SEC. 399II. ø280j–1¿ COLLECTION AND ANALYSIS OF DATA FOR QUAL- ITY AND RESOURCE USE MEASURES.
p.000589: (a) IN GENERAL.—
p.000589: (1) ESTABLISHMENT OF STRATEGIC FRAMEWORK.—The Sec- retary shall establish and implement an overall
p.000589: strategic framework to carry out the public reporting of performance in- formation, as described in section 399JJ. Such
p.000589: strategic frame- work may include methods and related timelines for imple- menting nationally consistent data
p.000589: collection, data aggregation, and analysis methods.
p.000589: (2) COLLECTION AND AGGREGATION OF DATA.—The Sec- retary shall collect and aggregate consistent data
p.000589: on quality and resource use measures from information systems used to support health care delivery, and
p.000589: may award grants or con- tracts for this purpose. The Secretary shall align such collec- tion and
p.000589: aggregation efforts with the requirements and assist- ance regarding the expansion of health information technology
p.000589: systems, the interoperability of such technology systems, and related standards that are in effect on the
p.000589: date of enactment of the Patient Protection and Affordable Care Act.
p.000589: (3) SCOPE.—The Secretary shall ensure that the data col- lection, data aggregation, and analysis systems
p.000589: described in paragraph (1) involve an increasingly broad range of patient populations, providers, and
p.000589: geographic areas over time.
p.000589: (b) GRANTS OR CONTRACTS FOR DATA COLLECTION.—
p.000589: (1) IN GENERAL.—The Secretary may award grants or con- tracts to eligible entities to support new, or improve
p.000589: existing, efforts to collect and aggregate quality and resource use meas- ures described under subsection (c).
p.000589: (2) ELIGIBLE ENTITIES.—To be eligible for a grant or con- tract under this subsection, an entity shall—
p.000589: (A) be—
p.000589: (i) a multi-stakeholder entity that coordinates the development of methods and implementation plans for the consistent
p.000589: reporting of summary quality and cost information;
p.000589: (ii) an entity capable of submitting such summary data for a particular population and providers, such as a disease
p.000589: registry, regional collaboration, health plan collaboration, or other population-wide source; or
p.000589: (iii) a Federal Indian Health Service program or a health program operated by an Indian tribe (as de- fined in
p.000589: section 4 of the Indian Health Care Improve- ment Act);
p.000589: (B) promote the use of the systems that provide data to improve and coordinate patient care;
p.000589: (C) support the provision of timely, consistent quality and resource use information to health care providers,
p.000589: and other groups and organizations as appropriate, with an op- portunity for providers to correct inaccurate measures;
p.000589: and
p.000589: (D) agree to report, as determined by the Secretary, measures on quality and resource use to the public ...

p.000649: (K) A provision that the Secretary may, in the discre- tion of the Secretary, accept into the system
p.000649: chimpanzees that are not surplus chimpanzees.
p.000649: (L) Such additional standards as the Secretary deter- mines to be appropriate.
p.000649: (3) RESTRICTIONS REGARDING RESEARCH.—
p.000649: (A) IN GENERAL.—For purposes of paragraph (2)(A), standards under paragraph (1) shall provide that a
p.000649: chim- panzee accepted into the sanctuary system may not be used for studies or research, except that the
p.000649: chimpanzee may be used for noninvasive behavioral studies or medical studies based on information collected during the
p.000649: course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any
p.000649: such study involves minimal physical and mental harm, pain, distress, and dis-
p.000649: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000651: PUBLIC HEALTH SERVICE ACT
p.000651: Sec. 404K
p.000651:
p.000651: turbance to the chimpanzee and the social group in which the chimpanzee lives.
p.000651: (B) ADDITIONAL RESTRICTION.—For purposes of para- graph (2)(A), a condition for the use in studies or research of
p.000651: a chimpanzee accepted into the sanctuary system is (in addition to conditions under subparagraph (A) of this para-
p.000651: graph) that the applicant for such use has not been fined for, or signed a consent decree for, any violation
p.000651: of the Ani- mal Welfare Act.
p.000651: (4) NON-FEDERAL CHIMPANZEES OFFERED FOR ACCEPTANCE INTO SYSTEM.—With respect to a chimpanzee that is not owned by
p.000651: the Federal Government and is offered for acceptance into the sanctuary system, standards under paragraph (1)
p.000651: shall in- clude the following:
p.000651: (A) A provision that the Secretary may authorize the imposition of a fee for accepting such chimpanzee into the
p.000651: system, except as follows:
p.000651: (i) Such a fee may not be imposed for accepting the chimpanzee if, on the day before the date of the
p.000651: enactment of this section, the chimpanzee was owned by the nonprofit private entity that receives the
p.000651: con- tract under subsection (e) or by any individual sanc- tuary facility receiving a subcontract or
p.000651: grant under subsection (e)(1).
p.000651: (ii) Such a fee may not be imposed for accepting the chimpanzee if the chimpanzee is owned by an enti- ty
p.000651: that operates a primate center, and if the chim- panzee is housed in the primate center pursuant to the
p.000651: program for regional centers for research on pri- mates that is carried out by the Director of NIH,
p.000651: act- ing through the Office of the Director of NIH,. 9
p.000651: Any fees collected under this subparagraph are available to the Secretary for the costs of operating the system.
p.000651: Any other fees received by the Secretary for the long-term care of chimpanzees (including any Federal fees that
p.000651: are col- lected for such purpose and are identified in the report under section 3 of the Chimpanzee
p.000651: Health Improvement, Maintenance, and Protection Act) are available for oper- ating the system, in addition to
p.000651: availability for such other purposes as may be authorized for the use of the fees.
p.000651: (B) A provision that the Secretary may deny such chimpanzee acceptance into the system if the capacity
p.000651: of the system is not sufficient to accept the chimpanzee, tak- ing into account the physical capacity of the system;
p.000651: the fi- nancial resources of the system; the number of individuals serving as the staff of the system, including the
p.000651: number of professional staff; the necessity of providing for the safety of the staff and of the public; the
p.000651: necessity of caring for ac- cepted chimpanzees in accordance with the standards under paragraph (1); and
p.000651: such other factors as may be ap- propriate.
p.000651:
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p.000651: January 30, 2020
p.000651: 9 A period followed by a comma in clause (ii) so in law. See amendment made by section 221(b)(3)(B) of
p.000651: division F of Public Law 112–74.
p.000651: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000651: (C) A provision that the Secretary may deny such chimpanzee acceptance into the system if a complete
p.000651: his- tory of the health and use in research of the chimpanzee is not available to the Secretary.
p.000651: (D) Such additional standards as the Secretary deter- mines to be appropriate.
p.000651: (e) AWARD OF CONTRACT FOR OPERATION OF SYSTEM.—
p.000651: (1) IN GENERAL.—Subject to the availability of funds pur- suant to subsection (g), the Secretary shall
p.000651: make an award of a contract to a nonprofit private entity under which the entity has the responsibility of ...

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p.000653: (iii) Such members include individuals with exper- tise and experience in the field of animal protection,
p.000653: appointed from among individuals endorsed by organi- zations that represent individuals in such field.
p.000653: (iv) Such members include individuals with exper- tise and experience in the zoological field (including
p.000653: behavioral primatology), appointed from among indi- viduals endorsed by organizations that represent indi- viduals
p.000653: in such field.
p.000653: (v) Such members include individuals with exper- tise and experience in the field of the business and
p.000653: management of nonprofit organizations, appointed from among individuals endorsed by organizations
p.000653: that represent individuals in such field.
p.000653: (vi) Such members include representatives from entities that provide accreditation in the field of lab-
p.000653: oratory animal medicine.
p.000653: (vii) Such members include individuals with ex- pertise and experience in the field of containing bio-
p.000653: hazards.
p.000653: (viii) Such members include an additional member who serves as the chair of the board, appointed from among
p.000653: individuals who have been endorsed for pur- poses of clause (ii), (iii), (iv), or (v).
p.000653: (ix) None of the members of the board has been fined for, or signed a consent decree for, any violation of the
p.000653: Animal Welfare Act.
p.000653: (B) The terms of service for members of the board of directors are in accordance with this paragraph
p.000653: if the fol- lowing conditions are met:
p.000653: (i) The term of the chair of the board is 3 years.
p.000653: (ii) The initial members of the board select, by a random method, one member from each of the six
p.000653: fields specified in subparagraph (A) to serve a term of
p.000653: 2 years and (in addition to the chair) one member from each of such fields to serve a term of 3 years.
p.000653: (iii) After the initial terms under clause (ii) expire, each member of the board (other than the chair) is ap- pointed
p.000653: to serve a term of 2 years.
p.000653: (iv) An individual whose term of service expires may be reappointed to the board.
p.000653: (v) A vacancy in the membership of the board is filled in the manner in which the original appointment was
p.000653: made.
p.000653: (vi) If a member of the board does not serve the full term applicable to the member, the individual ap-
p.000653: pointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor member.
p.000653: (4) REQUIREMENT OF MATCHING FUNDS.—The agreement required in paragraph (2)(E) for a nonprofit private entity
p.000653: (re- lating to the award of the contract under paragraph (1)) is an agreement that, with respect to the costs to be
p.000653: incurred by the entity in establishing and operating the sanctuary system, the entity will make available (directly
p.000653: or through donations from
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p.000707: Sec. 428 PUBLIC HEALTH SERVICE ACT 708
p.000707:
p.000707: of detection of individuals with a risk of developing kidney and uro- logic diseases, and (2) establish the
p.000707: National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and
p.000707: understanding of kidney and urologic diseases on the part of health professionals, patients, and the
p.000707: public through the effective dissemination of information.
p.000707: DIVISION DIRECTORS FOR DIABETES, ENDOCRINOLOGY, AND META- BOLIC DISEASES, DIGESTIVE DISEASES AND
p.000707: NUTRITION, AND KIDNEY, UROLOGIC, AND HEMATOLOGIC DISEASES
p.000707: SEC. 428. ø285c–2¿ (a)(1) In the Institute there shall be a Divi- sion Director for Diabetes, Endocrinology, and
p.000707: Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Di- vision Director for Kidney,
p.000707: Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the
p.000707: Institute, shall be responsible for—
p.000707: (A) developing a coordinated plan (including recommenda- tions for expenditures) for each of the national
p.000707: research insti- tutes within the National Institutes of Health with respect to research and training
p.000707: concerning diabetes, endocrine and met- abolic diseases, digestive diseases and nutrition, and kidney, urologic,
p.000707: and hematologic diseases;
p.000707: (B) assessing the adequacy of management approaches for the activities within such institutes concerning such
p.000707: diseases and nutrition and developing improved approaches if needed;
p.000707: (C) monitoring and reviewing expenditures by such insti- tutes concerning such diseases and nutrition; and
p.000707: (D) identifying research opportunities concerning such dis- eases and nutrition and recommending ways to utilize such
p.000707: op- portunities.
p.000707: (2) The Director of the Institute shall transmit to the Director of NIH the plans, recommendations, and reviews
p.000707: of the Division Directors under subparagraphs (A) through (D) of paragraph (1) to- gether with such comments and
p.000707: recommendations as the Director of the Institute determines appropriate.
p.000707: (b) The Director of the Institute, acting through the Division Director for Diabetes, Endocrinology, and
p.000707: Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the Di- vision Director for
p.000707: Kidney, Urologic, and Hematologic Diseases, shall—
p.000707: (1) carry out programs of support for research and training (other than training for which National
p.000707: Research Service Awards 24 may be made under section 487) in the diagnosis, prevention, and treatment of
p.000707: diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional dis- orders, and
p.000707: kidney, urologic, and hematologic diseases, includ- ing support for training in medical schools, graduate
p.000707: clinical training, graduate training in epidemiology, epidemiology stud- ies, clinical trials, and interdisciplinary
p.000707: research programs; and
p.000707: (2) establish programs of evaluation, planning, and dis- semination of knowledge related to such research and
p.000707: training.
p.000707:
p.000707:
p.000707:
p.000707: January 30, 2020
p.000707: 24 Now Ruth L. Kirschstein National Research Service Awards. See section 487. ...

p.000717: designees of such officers), and representatives of all other Federal departments and agencies (as determined
p.000717: by the Sec- retary) whose programs involve health functions or responsibilities relevant to arthritis and
p.000717: musculoskeletal diseases or skin diseases, as the case may be. Each Committee shall be chaired by the Direc- tor of NIH
p.000717: (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four
p.000717: times a year.
p.000717:
p.000717:
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p.000717: January 30, 2020
p.000717:
p.000717: ARTHRITIS AND MUSCULOSKELETAL DISEASES DEMONSTRATION PROJECTS
p.000717: SEC. 440. ø285d–5¿ (a) The Director of the Institute may make grants to public and private nonprofit entities to
p.000717: establish and sup- port projects for the development and demonstration of methods for screening, detection, and
p.000717: referral for treatment of arthritis and musculoskeletal diseases and for the dissemination of information
p.000717: on such methods to the health and allied health professions. Activi- ties under such projects shall be
p.000717: coordinated with Federal, State, local, and regional health agencies, centers assisted under section 441,
p.000717: and the data system established under subsection (c).
p.000717: (b) Projects supported under this section shall include—
p.000717: (1) programs which emphasize the development and dem- onstration of new and improved methods of screening
p.000717: and early detection, referral for treatment, and diagnosis of individ- uals with a risk of developing arthritis
p.000717: and musculoskeletal diseases;
p.000717: (2) programs which emphasize the development and dem- onstration of new and improved methods for patient
p.000717: referral from local hospitals and physicians to appropriate centers for early diagnosis and treatment;
p.000717: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000717:
p.000717:
p.000717:
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p.000717:
p.000717: Sec. 441 PUBLIC HEALTH SERVICE ACT 718
p.000717:
p.000717: (3) programs which emphasize the development and dem- onstration of new and improved means of
p.000717: standardizing pa- tient data and recordkeeping;
p.000717: (4) programs which emphasize the development and dem- onstration of new and improved methods of
p.000717: dissemination of knowledge about the programs, methods, and means referred to in paragraphs (1), (2), and
p.000717: (3) of this subsection to health and allied health professionals;
p.000717: (5) programs which emphasize the development and dem- onstration of new and improved methods for the
p.000717: dissemination to the general public of information—
p.000717: (A) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt
p.000717: treat- ment, and of following an appropriate regimen; and
p.000717: (B) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive treatment, and con-
p.000717: trol methods for arthritis and unapproved and ineffective drugs and devices for arthritis and ...

p.000737: (b) INSTITUTIONAL DEVELOPMENT AWARD PROGRAM.—
p.000737: (1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director
p.000737: of the Na- tional Institute of General Medical Sciences, shall establish a program to enhance the
p.000737: competitiveness of such entities in ob- taining funds from the national research institutes for con- ducting
p.000737: biomedical and behavioral research.
p.000737: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000737:
p.000737:
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p.000737:
p.000739: 739
p.000739: PUBLIC HEALTH SERVICE ACT
p.000739: Sec. 463A
p.000739:
p.000739: (B) The entities referred to in subparagraph (A) are enti- ties that conduct biomedical and behavioral
p.000739: research and are located in a State in which the aggregate success rate for ap- plications to the
p.000739: national research institutes for assistance for such research by the entities in the State has historically con-
p.000739: stituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States.
p.000739: (C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in
p.000739: carrying out the program established under such subparagraph, may—
p.000739: (i) provide technical assistance to the entities involved, including technical assistance in the preparation of
p.000739: appli- cations for obtaining funds from the national research in- stitutes;
p.000739: (ii) assist the entities in developing a plan for bio- medical or behavioral research proposals; and
p.000739: (iii) assist the entities in implementing such plan.
p.000739: (2) The Director of NIH shall establish a program of sup- porting projects of biomedical or behavioral
p.000739: research whose principal researchers are individuals who have not previously served as the principal
p.000739: researchers of such projects supported by the Director.
p.000739: Subpart 12—National Institute of Environmental Health Sciences
p.000739: PURPOSE OF THE INSTITUTE
p.000739: SEC. 463. ø285l¿ The general purpose of the National Institute of Environmental Health Sciences (in this subpart
p.000739: referred to as the ‘‘Institute’’) is the conduct and support of research, training, health information
p.000739: dissemination, and other programs with respect to factors in the environment that affect human health, directly or
p.000739: indirectly.
p.000739:
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p.000739:
p.000739: January 30, 2020
p.000739: APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM
p.000739: SEC. 463A. ø285l–1¿ (a) There is established within the Insti- tute a program for conducting applied research
p.000739: and testing regard- ing toxicology, which program shall be known as the Applied Toxi- cological Research and Testing
p.000739: Program.
p.000739: (b) In carrying out the program established under subsection (a), the Director of the Institute shall,
p.000739: with respect to toxicology, carry out activities—
p.000739: (1) to expand knowledge of the health effects of environ- mental agents; ...

p.000767: administration of this part for such periods, in addition to conference periods, as the Secretary may determine.
p.000767: (d) Appointed members of the Board who are not otherwise in the employ of the United States, while attending
p.000767: conferences of the Board or otherwise serving at the request of the Secretary in con- nection with the
p.000767: administration of this subpart, shall be entitled to receive compensation, per diem in lieu of subsistence, and
p.000767: travel expenses in the same manner and under the same conditions as that prescribed under section 208(c)
p.000767: when attending conferences, traveling, or serving at the request of the Secretary in connection with the
p.000767: Board’s function under this section.
p.000767:
p.000767:
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p.000767:
p.000767: January 30, 2020
p.000767:
p.000767: GRANTS FOR TRAINING IN MEDICAL LIBRARY SCIENCES
p.000767: SEC. 472. ø286b–3¿ The Secretary shall make grants—
p.000767: (1) to individuals to enable them to accept traineeships and fellowships leading to postbaccalaureate academic
p.000767: degrees in the field of medical library science, in related fields per- taining to sciences related to
p.000767: health, or in the field of the com- munication of information;
p.000767: (2) to individuals who are librarians or specialists in infor- mation on sciences relating to health, to enable them to
p.000767: under- go intensive training or retraining so as to attain greater com- petence in their occupations (including
p.000767: competence in the fields of automatic data processing and retrieval);
p.000767: (3) to assist appropriate public and private nonprofit insti- tutions in developing, expanding, and improving
p.000767: training pro- grams in library science and the field of communications of in- formation pertaining to sciences
p.000767: relating to health; and
p.000767: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000767:
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p.000769: 769
p.000769: PUBLIC HEALTH SERVICE ACT
p.000769: Sec. 474
p.000769:
p.000769: (4) to assist in the establishment of internship programs in established medical libraries meeting standards which the
p.000769: Sec- retary shall prescribe.
p.000769: ASSISTANCE FOR SPECIAL SCIENTIFIC PROJECTS, AND FOR RESEARCH AND DEVELOPMENT IN MEDICAL LIBRARY
p.000769: SCIENCE AND RELATED FIELDS
p.000769: SEC. 473. ø286b–4¿ (a) The Secretary shall make grants to physicians and other practitioners in the sciences
p.000769: related to health, to scientists, and to public or nonprofit private institutions on be- half of such
p.000769: physicians, other practitioners, and scientists for the compilation of existing, or the writing of original,
p.000769: contributions re- lating to scientific, social, or cultural advancements in sciences re- lated to health. In making
p.000769: such grants, the Secretary shall make appropriate arrangements under which the facilities of the Library and the
p.000769: facilities of libraries of public and private nonprofit institu- tions of higher learning may be made available in
p.000769: connection with the projects for which such grants are made. ...

p.000771: and dis- semination of knowledge concerning human molecular biology, biochemistry, and genetics;
p.000771: (2) perform research into advanced methods of computer- based information processing capable of representing and
p.000771: ana- lyzing the vast number of biologically important molecules and compounds;
p.000771: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000771:
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p.000773: 773
p.000773: PUBLIC HEALTH SERVICE ACT
p.000773: Sec. 479
p.000773:
p.000773: (3) enable persons engaged in biotechnology research and medical care to use systems developed under paragraph
p.000773: (1) and methods described in paragraph (2); and
p.000773: (4) coordinate, as much as is practicable, efforts to gather biotechnology information on an international
p.000773: basis.
p.000773: Subpart 4—National Information Center on Health Services Research and Health Care Technology
p.000773: NATIONAL INFORMATION CENTER
p.000773: SEC. 478A. ø286d¿ (a) There is established within the Library an entity to be known as the National Information
p.000773: Center on Health Services Research and Health Care Technology (in this sec- tion referred to as the ‘‘Center’’).
p.000773: (b) The purpose of the Center is the collection, storage, anal- ysis, retrieval, and dissemination of
p.000773: information on health services research, clinical practice guidelines, and on health care tech- nology,
p.000773: including the assessment of such technology. Such purpose includes developing and maintaining data bases and
p.000773: developing and implementing methods of carrying out such purpose.
p.000773: (c) The Director of the Center shall ensure that information under subsection (b) concerning clinical
p.000773: practice guidelines is col- lected and maintained electronically and in a convenient format. Such Director
p.000773: shall develop and publish criteria for the inclusion of practice guidelines and technology assessments in
p.000773: the informa- tion center database.
p.000773: (d) The Secretary, acting through the Center, shall coordinate the activities carried out under this
p.000773: section through the Center with related activities of the Administrator for Health Care Policy and
p.000773: Research.
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p.000773: January 30, 2020
p.000773: PART E—OTHER AGENCIES OF NIH
p.000773: Subpart 1—National Center for Advancing Translational Sciences
p.000773: SEC. 479. ø287¿ NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.
p.000773: (a) PURPOSE.—The purpose of the National Center for Advanc- ing Translational Sciences (in this subpart referred to as
p.000773: the ‘‘Cen- ter’’) is to advance translational sciences, including by—
p.000773: (1) coordinating and developing resources that leverage basic research in support of translational science; and
p.000773: (2) developing partnerships and working cooperatively to foster synergy in ways that do not create
p.000773: duplication, redun- dancy, and competition with industry activities.
p.000773: (b) CLINICAL TRIAL ACTIVITIES.— ...

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p.000783: 783
p.000783: PUBLIC HEALTH SERVICE ACT
p.000783: Sec. 485C
p.000783:
p.000783: (2) provide research programs, conferences, and seminars to further international cooperation and
p.000783: collaboration in the life sciences;
p.000783: (3) provide postdoctorate fellowships for research training in the United States and abroad and promote
p.000783: exchanges of senior scientists between the United States and other coun- tries;
p.000783: (4) coordinate the activities of the National Institutes of Health concerned with the health sciences
p.000783: internationally; and
p.000783: (5) receive foreign visitors to the National Institutes of Health.
p.000783: Subpart 4—Office of Dietary Supplements 50
p.000783: SEC. 485C. ø287c–11¿ DIETARY SUPPLEMENTS.
p.000783: (a) ESTABLISHMENT.—The Secretary shall establish an Office of Dietary Supplements within the National Institutes of
p.000783: Health.
p.000783: (b) PURPOSE.—The purposes of the Office are—
p.000783: (1) to explore more fully the potential role of dietary sup- plements as a significant part of the
p.000783: efforts of the United States to improve health care; and
p.000783: (2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing
p.000783: chronic dis- ease and other health-related conditions.
p.000783: (c) DUTIES.—The Director of the Office of Dietary Supplements shall—
p.000783: (1) conduct and coordinate scientific research within the National Institutes of Health relating to
p.000783: dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of
p.000783: diseases such as heart disease, can- cer, birth defects, osteoporosis, cataracts, or prostatism;
p.000783: (2) collect and compile the results of scientific research re- lating to dietary supplements, including scientific
p.000783: data from foreign sources or the Office of Alternative Medicine;
p.000783: (3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and
p.000783: provide advice to the Director of the National Institutes of Health, the Director of the Centers for
p.000783: Disease Control and Prevention, and the Com- missioner of Food and Drugs on issues relating to dietary sup- plements
p.000783: including—
p.000783: (A) dietary intake regulations;
p.000783: (B) the safety of dietary supplements;
p.000783: (C) claims characterizing the relationship between—
p.000783: (i) dietary supplements; and
p.000783: (ii)(I) prevention of disease or other health-related conditions; and
p.000783: (II) maintenance of health; and
p.000783: (D) scientific issues arising in connection with the la- beling and composition of dietary supplements;
p.000783: (4) compile a database of scientific research on dietary sup- plements and individual nutrients; and
p.000783:
p.000783:
p.000783:
p.000783:
p.000783: January 30, 2020
p.000783: 50 Subpart 3 of this part was transferred and redesignated as subpart 19 of part C by section 101(c) of Public Law
p.000783: 109–482.
p.000783: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000783: Sec. 485D PUBLIC HEALTH SERVICE ACT 784 ...

p.000797: subsection (a) under an arrangement under which the actual expenses incurred by such Academy in conducting
p.000797: such study will be paid by the Secretary. If the National Academy of Sciences is willing to do so,
p.000797: the Sec- retary shall enter into such an arrangement with such Academy for the conduct of such study.
p.000797: (2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the
p.000797: Secretary shall enter into a similar arrangement with other appropriate nonprofit
p.000797: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000797:
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p.000797: Sec. 491 PUBLIC HEALTH SERVICE ACT 798
p.000797:
p.000797: private groups or associations under which such groups or associa- tions will conduct such study and prepare and
p.000797: submit the reports thereon as provided in subsection (c).
p.000797: (3) The National Academy of Sciences or other group or asso- ciation conducting the study required by
p.000797: subsection (a) shall con- duct such study in consultation with the Director of NIH.
p.000797: (c) A report on the results of the study required under sub- section (a) shall be submitted by the
p.000797: Secretary to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and
p.000797: Human Resources of the Senate at least once every four years.
p.000797: PART H—GENERAL PROVISIONS
p.000797: INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
p.000797: SEC. 491. ø289¿ (a) The Secretary shall by regulation require that each entity which applies for a grant,
p.000797: contract, or cooperative agreement under this Act for any project or program which in- volves the conduct
p.000797: of biomedical or behavioral research involving human subjects submit in or with its application for such
p.000797: grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established
p.000797: (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an
p.000797: ‘‘Institutional Review Board’’) to review biomedical and behavioral research involving human subjects
p.000797: conducted at or supported by such entity in order to protect the rights of the human subjects of such research.
p.000797: (b)(1) The Secretary shall establish a program within the De- partment of Health and Human Services under
p.000797: which requests for clarification and guidance with respect to ethical issues raised in connection with
p.000797: biomedical or behavioral research involving human subjects are responded to promptly and appropriately.
p.000797: (2) The Secretary shall establish a process for the prompt and appropriate response to information provided to
p.000797: the Director of NIH respecting incidences of violations of the rights of human sub- jects of research for which
p.000797: funds have been made available under this Act. The process shall include procedures for the receiving of
p.000797: reports of such information from recipients of funds under this Act and taking appropriate action with respect to such
p.000797: violations.
p.000797: PEER REVIEW REQUIREMENTS
p.000797: SEC. 492. ø289a¿ (a)(1) The Secretary, acting through the Di- rector of NIH, shall by regulation require
p.000797: appropriate technical and scientific peer review of—
p.000797: (A) applications made for grants and cooperative agree- ments under this Act for biomedical and
p.000797: behavioral research; and
p.000797:
p.000797:
p.000797:
p.000797:
p.000797:
p.000797:
p.000797: January 30, 2020
p.000797: (B) applications made for biomedical and behavioral re- search and development contracts to be
p.000797: administered through the National Institutes of Health.
p.000797: (2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants,
p.000797: contracts, and co- operative agreements required by the regulations be conducted—
p.000797: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000797:
p.000797:
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p.000797: ...

p.000811:
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p.000811: January 30, 2020
p.000811: RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
p.000811: SEC. 498A. ø289g–1¿ (a) ESTABLISHMENT OF PROGRAM.—
p.000811: (1) IN GENERAL.—The Secretary may conduct or support research on the transplantation of human fetal
p.000811: tissue for therapeutic purposes.
p.000811: (2) SOURCE OF TISSUE.—Human fetal tissue may be used in research carried out under paragraph (1)
p.000811: regardless of
p.000811: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.000811:
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p.000811: Sec. 498A PUBLIC HEALTH SERVICE ACT 812
p.000811:
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p.000811: January 30, 2020
p.000811:
p.000811: whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.
p.000811: (b) INFORMED CONSENT OF DONOR.—
p.000811: (1) IN GENERAL.—In research carried out under subsection (a), human fetal tissue may be used only if the
p.000811: woman pro- viding the tissue makes a statement, made in writing and signed by the woman, declaring that—
p.000811: (A) the woman donates the fetal tissue for use in re- search described in subsection (a);
p.000811: (B) the donation is made without any restriction re- garding the identity of individuals who may be the recipi-
p.000811: ents of transplantations of the tissue; and
p.000811: (C) the woman has not been informed of the identity of any such individuals.
p.000811: (2) ADDITIONAL STATEMENT.—In research carried out under subsection (a), human fetal tissue may be used only if
p.000811: the at- tending physician with respect to obtaining the tissue from the woman involved makes a statement, made
p.000811: in writing and signed by the physician, declaring that—
p.000811: (A) in the case of tissue obtained pursuant to an in- duced abortion—
p.000811: (i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of
p.000811: the tissue for use in such research;
p.000811: (ii) no alteration of the timing, method, or proce- dures used to terminate the pregnancy was made sole- ly for
p.000811: the purposes of obtaining the tissue; and
p.000811: (iii) the abortion was performed in accordance with applicable State law;
p.000811: (B) the tissue has been donated by the woman in ac- cordance with paragraph (1); and
p.000811: (C) full disclosure has been provided to the woman with regard to—
p.000811: (i) such physician’s interest, if any, in the research to be conducted with the tissue; and
p.000811: (ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of
p.000811: the tissue and that are in addition to risks of such type that are associated with the woman’s medical care.
p.000811: (c) INFORMED CONSENT OF RESEARCHER AND DONEE.—In re- search carried out under subsection (a), human fetal
p.000811: tissue may be used only if the individual with the principal responsibility for con- ducting the research involved
p.000811: makes a statement, made in writing and signed by the individual, declaring that the individual—
p.000811: (1) is aware that—
p.000811: (A) the tissue is human fetal tissue;
p.000811: (B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a
p.000811: still- birth; and
p.000811: (C) the tissue was donated for research purposes;
p.000811: (2) has provided such information to other individuals with responsibilities regarding the research;
p.000811: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000813: 813
p.000813: PUBLIC HEALTH SERVICE ACT
p.000813: Sec. 498A
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p.000813: (3) will require, prior to obtaining the consent of an indi- vidual to be a recipient of a transplantation of
p.000813: the tissue, writ- ten acknowledgment of receipt of such information by such re- cipient; and
p.000813: (4) has had no part in any decisions as to the timing, method, or procedures used to terminate the
p.000813: pregnancy made solely for the purposes of the research.
p.000813: (d) AVAILABILITY OF STATEMENTS FOR AUDIT.—
p.000813: (1) IN GENERAL.—In research carried out under subsection (a), human fetal tissue may be used only if the head
p.000813: of the agency or other entity conducting the research involved cer- tifies to the Secretary that the
p.000813: statements required under sub- sections (b)(2) and (c) will be available for audit by the Sec- retary.
p.000813: (2) CONFIDENTIALITY OF AUDIT.—Any audit conducted by the Secretary pursuant to paragraph (1) shall be
p.000813: conducted in a confidential manner to protect the privacy rights of the indi- viduals and entities involved in
p.000813: such research, including such individuals and entities involved in the donation, transfer, re- ceipt, or
p.000813: transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such
p.000813: audit, the Secretary shall—
p.000813: (A) use such material or information only for the pur- poses of verifying compliance with the requirements of this
p.000813: section;
p.000813: (B) not disclose or publish such material or informa- tion, except where required by Federal law, in
p.000813: which case such material or information shall be coded in a manner such that the identities of such
p.000813: individuals and entities are protected; and
p.000813: (C) not maintain such material or information after completion of such audit, except where necessary for
p.000813: the purposes of such audit.
p.000813: (e) APPLICABILITY OF STATE AND LOCAL LAW.—
p.000813: (1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE.— The Secretary may not provide support for research under sub-
p.000813: section (a) unless the applicant for the financial assistance in- volved agrees to conduct the research in accordance
p.000813: with appli- cable State law.
p.000813: (2) RESEARCH CONDUCTED BY SECRETARY.—The Secretary may conduct research under subsection (a) only in
p.000813: accordance with applicable State and local law.
p.000813: (f) REPORT.—The Secretary shall annually submit to the Com- mittee on Energy and Commerce of the House of
p.000813: Representatives, and to the Committee on Labor and Human Resources of the Sen- ate, a report describing the activities
p.000813: carried out under this section during the preceding fiscal year, including a description of whether and to what ...

p.000963: Each loan shall bear interest at the rate arrived at by adding one-quarter of 1 per cen- tum per annum to
p.000963: the rate which the Secretary of the Treasury de- termines to be equal to the current average yield on all outstanding
p.000963: marketable obligations of the United States as of the last day of the month preceding the date the
p.000963: application for the loan is ap- proved and by adjusting the result so obtained to the nearest one- eighth of 1 per
p.000963: centum. Each loan made under this part shall ma- ture not more than forty years after the date on which such
p.000963: loan is made, except that nothing in this part shall prohibit the pay- ment of all or part of the
p.000963: loan at any time prior to the maturity date. In addition to the terms and conditions provided for,
p.000963: each loan under this part shall be made subject to such terms, condi- tions, and covenants relating to
p.000963: repayment of principal, payment of interest, and other matters as may be agreed upon by the applicant and the Surgeon
p.000963: General.
p.000963: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000965: 965
p.000965: PUBLIC HEALTH SERVICE ACT
p.000965: Sec. 622
p.000965:
p.000965: (2) The Surgeon General may enter into agreements modifying any of the terms and conditions of a loan made
p.000965: under this part whenever he determines such action is necessary to protect the fi- nancial interest of the
p.000965: United States.
p.000965: (3) If, at any time before a loan for a project has been repaid in full, any of the events specified in
p.000965: clause (a) or clause (b) of sec- tion 609 occurs with respect to such project, the unpaid balance of the loan shall
p.000965: become immediately due and payable by the appli- cant, and any transferee of the facility shall be liable to the
p.000965: United States for such repayment.
p.000965: (d) Any loan under this part shall be made out of the allotment from which a grant for the project concerned would be
p.000965: made. Pay- ments of interest and repayments of principal on loans under this part shall be deposited in
p.000965: the Treasury as miscellaneous receipts.
p.000965: PART B—LOAN GUARANTEES AND LOANS FOR MODERNIZATION AND
p.000965: CONSTRUCTION OF HOSPITALS AND OTHER MEDICAL FACILITIES
p.000965: AUTHORIZATION OF LOAN GUARANTEES AND LOANS
p.000965:
p.000965: SEC. 621. ø291j–1¿ (a)(1) In order to assist nonprofit private agencies to carry out needed projects for the
p.000965: modernization or con- struction of nonprofit private hospitals, facilities for long-term care, outpatient facilities,
p.000965: and rehabilitation facilities, the Secretary, during the period July 1, 1970, through June 30, 1974, may, in
p.000965: ac- cordance with the provisions of this part, guarantee to non-Federal lenders making loans to such agencies for
p.000965: such projects, payment of principal of and interest on loans, made by such lenders, which are approved
p.000965: under this part.
p.000965: (2) In order to assist public agencies to carry out needed projects for the modernization or construction of
p.000965: public health cen- ters, and public hospitals, facilities for long-term care, outpatient facilities, and
p.000965: rehabilitation facilities, the Secretary, during the pe- riod July 1, 1970, through June 30, 1974, may, in accordance
p.000965: with the provisions of this part, make loans to such agencies which shall be sold and guaranteed in accordance with
p.000965: section 627.
p.000965: (b)(1) No loan guarantee under this part with respect to any modernization or construction project may apply
p.000965: to so much of the principal amount thereof as, when added to the amount of any grant or loan under part A
p.000965: with respect to such project, exceeds 90 per centum of the cost of such project.
p.000965: (2) No loan to a public agency under this part shall be made in an amount which, when added to the
p.000965: amount of any grant or loan under part A with respect to such project, exceeds 90 per cen- tum of the cost of such
p.000965: project.
p.000965: (c) The Secretary, with the consent of the Secretary of Housing and Urban Development, shall obtain from the
p.000965: Department of Housing and Urban Development such assistance with respect to the administration of this part as
p.000965: will promote efficiency and econ- omy thereof.
p.000965:
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p.000965: January 30, 2020
p.000965: ALLOCATION AMONG THE STATES
p.000965: SEC. 622. ø291j–2¿ (a) For each fiscal year, the total amount of principal of loans to nonprofit
p.000965: private agencies which may be
p.000965: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000965: Sec. 623 PUBLIC HEALTH SERVICE ACT 966
p.000965:
p.000965: guaranteed or loans to public agencies which may be directly made under this part shall be allotted by the Secretary
p.000965: among the States, in accordance with regulations, on the basis of each State’s relative population, financial need,
p.000965: need for construction of the facilities re- ferred to in section 621(a), and need for modernization of such
p.000965: fa- cilities.
p.000965: (b) Any amount allotted under subsection (a) to a State for a fiscal year ending before July 1, 1973,
p.000965: and remaining unobligated at the end of such year shall remain available to such State, for the purpose
p.000965: for which made, for the next two fiscal years (and for such years only), and any such amount shall be in
p.000965: addition to the amounts allotted to such State for such purpose for each of such next two fiscal years;
p.000965: except that, with the consent of any such State, any such amount remaining unobligated at the end of
p.000965: the first of such next fiscal year may be reallotted (on such basis as the Secretary deems equitable and consistent
p.000965: with the purposes of this title) to other States which have need therefor. Any amounts so re- allotted to a State
p.000965: shall be available for the purposes for which made until the close of the second such next two fiscal
p.000965: years and shall be in addition to the amount allotted and available to such State for the same period.
p.000965: (c) Any amount allotted or reallotted to a State under this sec- tion for a fiscal year shall not, until the
p.000965: expiration of the period during which it is available for obligation, be considered as avail- able for
p.000965: allotment for a subsequent fiscal year.
p.000965: (d) The allotments of any State under subsection (a) for the fis- cal year ending June 30, 1971, and the succeeding
p.000965: fiscal year shall also be available to guarantee loans with respect to any project, for modernization or construction
p.000965: of a nonprofit private hospital or other health facility referred to in section 621(a)(1), if the mod-
p.000965: ernization or construction of such facility was not commenced ear- lier than January 1, 1968, and if
p.000965: the State certifies and the Sec- retary finds that without such guaranteed loan such facility could not
p.000965: be completed and begin to operate or could not continue to op- erate, but with such guaranteed loan would be
p.000965: able to do so: Pro- vided, That this subsection shall not apply to more than two projects in any one
p.000965: State.
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p.000989: (1) LOW-RISK RATE.—With respect to an eligible borrower seeking to obtain a loan for attendance at an
p.000989: eligible institu- tion that has a default rate of not to exceed five percent, such borrower shall be assessed a
p.000989: risk-based premium in an amount equal to 6 percent of the principal amount of the loan.
p.000989: (2) MEDIUM-RISK RATE.—
p.000989: (A) IN GENERAL.—With respect to an eligible borrower seeking to obtain a loan for attendance at an eligible insti-
p.000989: tution that has a default rate of in excess of five percent but not to exceed 10 percent—
p.000989: (i) such borrower shall be assessed a risk-based premium in an amount equal to 8 percent of the prin- cipal
p.000989: amount of the loan; and
p.000989: (ii) such institution shall be assessed a risk-based premium in an amount equal to 5 percent of the prin- cipal amount
p.000989: of the loan.
p.000989: (B) DEFAULT MANAGEMENT PLAN.—An institution of the type described in subparagraph (A) shall prepare
p.000989: and submit to the Secretary for approval, an annual default management plan, that shall specify the
p.000989: detailed short- term and long-term procedures that such institution will have in place to minimize
p.000989: defaults on loans to borrowers under this subpart. Under such plan the institution shall, among other measures,
p.000989: provide an exit interview to all borrowers that includes information concerning repayment schedules, loan
p.000989: deferments, forbearance, and the con- sequences of default.
p.000989: (3) HIGH-RISK RATE.—
p.000989: (A) IN GENERAL.—With respect to an eligible borrower seeking to obtain a loan for attendance at an eligible insti-
p.000989: tution that has a default rate of in excess of 10 percent but not to exceed 20 percent—
p.000989: (i) such borrower shall be assessed a risk-based premium in an amount equal to 8 percent of the prin- cipal
p.000989: amount of the loan; and
p.000989: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.000989: Sec. 709 PUBLIC HEALTH SERVICE ACT 990
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p.000989:
p.000989: (ii) such institution shall be assessed a risk-based premium in an amount equal to 10 percent of the prin- cipal amount
p.000989: of the loan.
p.000989: (B) DEFAULT MANAGEMENT PLAN.—An institution of the type described in subparagraph (A) shall prepare
p.000989: and submit to the Secretary for approval a plan that meets the requirements of paragraph (2)(B).
p.000989: (4) INELIGIBILITY.—An individual shall not be eligible to obtain a loan under this subpart for attendance
p.000989: at an institu- tion that has a default rate in excess of 20 percent. ...

p.001041: (B) have completed an approved fellowship program in geriatrics or have completed specialty training in geriatrics as
p.001041: required by the discipline and any addition geriatrics training as required by the Secretary; and
p.001041: (C) have a junior (non-tenured) faculty appointment at an accredited (as determined by the Secretary) school of
p.001041: medicine, osteopathic medicine, nursing, social work, psy- chology, dentistry, pharmacy, or other allied
p.001041: health dis- ciplines in an accredited health professions school that is approved by the Secretary.
p.001041: (3) LIMITATIONS.—No Award under paragraph (1) may be made to an eligible individual unless the individual—
p.001041: (A) has submitted to the Secretary an application, at such time, in such manner, and containing such
p.001041: informa- tion as the Secretary may require, and the Secretary has approved such application;
p.001041: (B) provides, in such form and manner as the Sec- retary may require, assurances that the individual
p.001041: will meet the service requirement described in paragraph (6); and
p.001041:
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p.001041: (C) provides, in such form and manner as the Sec- retary may require, assurances that the individual
p.001041: has a full-time faculty appointment in a health professions insti- tution and documented commitment from such
p.001041: institution to spend 75 percent of the total time of such individual on teaching and developing skills in
p.001041: interdisciplinary edu- cation in geriatrics.
p.001041: (4) MAINTENANCE OF EFFORT.—An eligible individual that receives an Award under paragraph (1) shall provide
p.001041: assur- ances to the Secretary that funds provided to the eligible indi- vidual under this subsection will be
p.001041: used only to supplement, not to supplant, the amount of Federal, State, and local funds otherwise expended by the
p.001041: eligible individual.
p.001041: (5) AMOUNT AND TERM.—
p.001041: (A) AMOUNT.—The amount of an Award under this section for individuals who are physicians shall
p.001041: equal
p.001041: $50,000 for fiscal year 1998, adjusted for subsequent fiscal years to reflect the increase in the Consumer Price Index.
p.001041: The Secretary shall determine the amount of an Award under this section for individuals who are not
p.001041: physicians.
p.001041: (B) TERM.—The term of any Award made under this subsection shall not exceed 5 years.
p.001041: (C) PAYMENT TO INSTITUTION.—The Secretary shall make payments to institutions which include schools of
p.001041: medicine, osteopathic medicine, nursing, social work, psy- chology, dentistry, and pharmacy, or other
p.001041: allied health discipline in an accredited health professions school that is approved by the Secretary.
p.001041: (6) SERVICE REQUIREMENT.—An individual who receives an Award under this subsection shall provide training in
p.001041: clinical geriatrics, including the training of interdisciplinary teams of health care professionals. The
p.001041: provision of such training shall
p.001041: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001041:
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p.001073: individually identifiable personal data (hereinafter in this subsection re- ferred to as ‘‘personal data’’) for
p.001073: purposes of this section—
p.001073: (A) inform any individual who is asked to supply per- sonal data whether he is legally required, or may
p.001073: refuse, to supply such data and inform him of any specific con- sequences, known to the Secretary or
p.001073: program entity, as the case may be, of providing or not providing such data;
p.001073: (B) upon request, inform any individual if he is the subject of personal data secured or maintained by the
p.001073: Sec- retary or program entity, as the case may be, and make the data available to him in a form
p.001073: comprehensible to him;
p.001073: (C) assure that no use is made of personal data which use is not within the purposes of this section unless an in-
p.001073: formed consent has been obtained from the individual who is the subject of such data; and
p.001073: (D) upon request, inform any individual of the use being made of personal data respecting such
p.001073: individual and of the identity of the individuals and entities which will use the data and their
p.001073: relationship to the programs under this section.
p.001073: (2) CONSENT AS PRECONDITION TO DISCLOSURE.—Any entity which maintains a record of personal data and which
p.001073: receives a request from the Secretary or a program entity for such data for purposes of this section shall not transfer
p.001073: any such data to the Secretary or to a program entity unless the individual whose personal data is to be
p.001073: so transferred gives an informed consent for such transfer.
p.001073: (3) DISCLOSURE BY SECRETARY.—
p.001073: (A) Notwithstanding any other provision of law, per- sonal data collected by the Secretary or any program enti-
p.001073: ty under this section may not be made available or dis- closed by the Secretary or any program entity
p.001073: to any per- son other than the individual who is the subject of such data unless (i) such person requires
p.001073: such data for purposes of this section, or (ii) in response to a demand for such data made by means of
p.001073: compulsory legal process. Any indi- vidual who is the subject of personal data made available or disclosed
p.001073: under clause (ii) shall be notified of the de- mand for such data.
p.001073: (B) Subject to all applicable laws regarding confiden- tiality, only the data collected by the Secretary under
p.001073: this section which is not personal data shall be made available to bona fide researchers and policy analysts (including
p.001073: the Congress) for the purposes of assisting in the conduct of studies respecting health professions personnel.
p.001073:
p.001073:
p.001073:
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p.001073: 18 So in law. Probably should be redesignated as (d).
p.001073: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001075: 1075
p.001075: PUBLIC HEALTH SERVICE ACT
p.001075: Sec. 794
p.001075:
p.001075: (4) DEFINITION.—For purposes of this subsection, the term ‘‘program entity’’ means any public or private entity which ...

p.001113: (8) health statistics, surveys, database development, and epidemiology; and
p.001113: (9) medical liability.
p.001113: (b) HEALTH SERVICES TRAINING GRANTS.—
p.001113: (1) IN GENERAL.—The Director may provide training grants in the field of health services research related to
p.001113: activities au- thorized under subsection (a), to include pre- and post-doctoral fellowships and training programs,
p.001113: young investigator awards, and other programs and activities as appropriate. In carrying out this subsection,
p.001113: the Director shall make use of funds made available under section 487(d)(3) as well as other appropriated funds.
p.001113: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001113: Sec. 903 PUBLIC HEALTH SERVICE ACT 1114
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p.001113: January 30, 2020
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p.001113: (2) REQUIREMENTS.—In developing priorities for the alloca- tion of training funds under this subsection, the Director
p.001113: shall take into consideration shortages in the number of trained re- searchers who are addressing health care
p.001113: issues for the pri- ority populations identified in section 901(c)(1)(B) and in addi- tion, shall take into
p.001113: consideration indications of long-term com- mitment, amongst applicants for training funds, to addressing health
p.001113: care needs of the priority populations.
p.001113: (c) MULTIDISCIPLINARY CENTERS.—The Director may provide fi- nancial assistance to assist in meeting the costs of
p.001113: planning and es- tablishing new centers, and operating existing and new centers, for multidisciplinary health
p.001113: services research, demonstration projects, evaluations, training, and policy analysis with respect to the
p.001113: mat- ters referred to in subsection (a).
p.001113: (d) RELATION TO CERTAIN AUTHORITIES REGARDING SOCIAL SE- CURITY.—Activities authorized in this section shall be
p.001113: appropriately coordinated with experiments, demonstration projects, and other related activities authorized by
p.001113: the Social Security Act and the So- cial Security Amendments of 1967. Activities under subsection (a)(2) of
p.001113: this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act shall
p.001113: be carried out con- sistent with section 1142 of such Act.
p.001113: (e) DISCLAIMER.—The Agency shall not mandate national standards of clinical practice or quality health care
p.001113: standards. Rec- ommendations resulting from projects funded and published by the Agency shall include a corresponding
p.001113: disclaimer.
p.001113: (f) RULE OF CONSTRUCTION.—Nothing in this section shall be construed to imply that the Agency’s role is to ...

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p.001125: January 30, 2020
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p.001125: (3) NONIDENTIFIABLE PATIENT SAFETY WORK PRODUCT.— The term ‘‘nonidentifiable patient safety work
p.001125: product’’ means patient safety work product that is not identifiable patient safety work product (as defined
p.001125: in paragraph (2)).
p.001125: (4) PATIENT SAFETY ORGANIZATION.—The term ‘‘patient safety organization’’ means a private or public entity
p.001125: or compo- nent thereof that is listed by the Secretary pursuant to section 924(d).
p.001125: (5) PATIENT SAFETY ACTIVITIES.—The term ‘‘patient safety activities’’ means the following activities:
p.001125: (A) Efforts to improve patient safety and the quality of health care delivery.
p.001125: (B) The collection and analysis of patient safety work product.
p.001125: (C) The development and dissemination of information with respect to improving patient safety, such as rec-
p.001125: ommendations, protocols, or information regarding best practices.
p.001125: (D) The utilization of patient safety work product for the purposes of encouraging a culture of safety and of
p.001125: pro- viding feedback and assistance to effectively minimize pa- tient risk.
p.001125: (E) The maintenance of procedures to preserve con- fidentiality with respect to patient safety work product.
p.001125: (F) The provision of appropriate security measures with respect to patient safety work product.
p.001125: (G) The utilization of qualified staff.
p.001125: (H) Activities related to the operation of a patient safety evaluation system and to the provision of
p.001125: feedback to participants in a patient safety evaluation system.
p.001125: (6) PATIENT SAFETY EVALUATION SYSTEM.—The term ‘‘pa- tient safety evaluation system’’ means the
p.001125: collection, manage- ment, or analysis of information for reporting to or by a patient safety organization.
p.001125: (7) PATIENT SAFETY WORK PRODUCT.—
p.001125: (A) IN GENERAL.—Except as provided in subparagraph (B), the term ‘‘patient safety work product’’ means any
p.001125: data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements—
p.001125: (i) which—
p.001125: (I) are assembled or developed by a provider for reporting to a patient safety organization and are
p.001125: reported to a patient safety organization; or
p.001125: (II) are developed by a patient safety organi- zation for the conduct of patient safety activities; and
p.001125: which could result in improved patient safety,
p.001125: health care quality, or health care outcomes; or
p.001125: (ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting
p.001125: pursu- ant to, a patient safety evaluation system.
p.001125: (B) CLARIFICATION.—
p.001125: (i) Information described in subparagraph (A) does not include a patient’s medical record, billing and dis-
p.001125: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001133: January 30, 2020
p.001133: (1) IN GENERAL.—The following are criteria for the initial and subsequent certification of an entity as a
p.001133: patient safety or- ganization:
p.001133: (A) The mission and primary activity of the entity are to conduct activities that are to improve patient safety and the
p.001133: quality of health care delivery.
p.001133: (B) The entity has appropriately qualified staff (whether directly or through contract), including
p.001133: licensed or certified medical professionals.
p.001133: (C) The entity, within each 24-month period that be- gins after the date of the initial listing under
p.001133: subsection (d), has bona fide contracts, each of a reasonable period of time, with more than 1 provider for the purpose
p.001133: of receiv- ing and reviewing patient safety work product.
p.001133: (D) The entity is not, and is not a component of, a health insurance issuer (as defined in section
p.001133: 2791(b)(2)).
p.001133: (E) The entity shall fully disclose—
p.001133: (i) any financial, reporting, or contractual relation- ship between the entity and any provider that con-
p.001133: tracts with the entity; and
p.001133: (ii) if applicable, the fact that the entity is not managed, controlled, and operated independently from any
p.001133: provider that contracts with the entity.
p.001133: (F) To the extent practical and appropriate, the entity collects patient safety work product from providers in
p.001133: a standardized manner that permits valid comparisons of similar cases among similar providers.
p.001133: (G) The utilization of patient safety work product for the purpose of providing direct feedback and assistance
p.001133: to providers to effectively minimize patient risk.
p.001133: (2) ADDITIONAL CRITERIA FOR COMPONENT ORGANIZA- TIONS.—If an entity that seeks to be a patient
p.001133: safety organiza- tion is a component of another organization, the following are additional criteria for the
p.001133: initial and subsequent certification of the entity as a patient safety organization:
p.001133: (A) The entity maintains patient safety work product separately from the rest of the organization, and
p.001133: estab- lishes appropriate security measures to maintain the con- fidentiality of the patient safety work
p.001133: product.
p.001133: (B) The entity does not make an unauthorized disclo- sure under this part of patient safety work product to the
p.001133: rest of the organization in breach of confidentiality.
p.001133: (C) The mission of the entity does not create a conflict of interest with the rest of the organization.
p.001133: (c) REVIEW OF CERTIFICATION.—
p.001133: (1) IN GENERAL.—
p.001133: (A) INITIAL CERTIFICATION.—Upon the submission by an entity of an initial certification under subsection
p.001133: (a)(1), the Secretary shall determine if the certification meets the requirements of subparagraphs (A) and (B) of
p.001133: such sub- section.
p.001133: (B) SUBSEQUENT CERTIFICATION.—Upon the submis- sion by an entity of a subsequent certification under sub-
p.001133: section (a)(2), the Secretary shall review the certification
p.001133: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001135: clinicians in the delivery of health care services.
p.001135: (b) IDENTIFICATION OF QUALITY MEASURES.—
p.001135: (1) IDENTIFICATION.—The Secretary, in consultation with the Director of the Agency for Healthcare Research
p.001135: and Qual- ity and the Administrator of the Centers for Medicare & Med- icaid Services, shall identify, not less
p.001135: often than triennially, gaps where no quality measures exist and existing quality measures that need
p.001135: improvement, updating, or expansion, con- sistent with the national strategy under section 399HH, to the extent
p.001135: available, for use in Federal health programs. In identi- fying such gaps and existing quality measures that
p.001135: need im- provement, the Secretary shall take into consideration—
p.001135: (A) the gaps identified by the entity with a contract under section 1890(a) of the Social Security Act and
p.001135: other stakeholders;
p.001135: (B) quality measures identified by the pediatric qual- ity measures program under section 1139A of the
p.001135: Social Security Act; and
p.001135: (C) quality measures identified through the Medicaid Quality Measurement Program under section 1139B of the
p.001135: Social Security Act.
p.001135: (2) PUBLICATION.—The Secretary shall make available to the public on an Internet website a report on any gaps
p.001135: identi- fied under paragraph (1) and the process used to make such identification.
p.001135: (c) GRANTS OR CONTRACTS FOR QUALITY MEASURE DEVELOP-
p.001135: MENT.—
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p.001135: January 30, 2020
p.001135: (1) IN GENERAL.—The Secretary shall award grants, con- tracts, or intergovernmental agreements to eligible
p.001135: entities for purposes of developing, improving, updating, or expanding quality measures identified under
p.001135: subsection (b).
p.001135: (2) PRIORITIZATION IN THE DEVELOPMENT OF QUALITY MEAS- URES.—In awarding grants, contracts, or agreements
p.001135: under this subsection, the Secretary shall give priority to the develop- ment of quality measures that allow the
p.001135: assessment of—
p.001135: (A) health outcomes and functional status of patients;
p.001135: (B) the management and coordination of health care across episodes of care and care transitions for
p.001135: patients
p.001135: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001137: 1137
p.001137: PUBLIC HEALTH SERVICE ACT
p.001137: Sec. 931
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p.001137: across the continuum of providers, health care settings, and health plans;
p.001137: (C) the experience, quality, and use of information pro- vided to and used by patients, caregivers, and
p.001137: authorized representatives to inform decisionmaking about treatment options, including the use of shared
p.001137: decisionmaking tools and preference sensitive care (as defined in section 936);
p.001137: (D) the meaningful use of health information tech- nology;
p.001137: (E) the safety, effectiveness, patient-centeredness, ap- propriateness, and timeliness of care;
p.001137: (F) the efficiency of care;
p.001137: (G) the equity of health services and health disparities across health disparity populations (as defined in
p.001137: section 485E) and geographic areas;
p.001137: (H) patient experience and satisfaction;
p.001137: (I) the use of innovative strategies and methodologies identified under section 933; and
p.001137: (J) other areas determined appropriate by the Sec- retary.
p.001137: (3) ELIGIBLE ENTITIES.—To be eligible for a grant or con- tract under this subsection, an entity shall—
p.001137: (A) have demonstrated expertise and capacity in the development and evaluation of quality measures;
p.001137: (B) have adopted procedures to include in the quality measure development process—
p.001137: (i) the views of those providers or payers whose performance will be assessed by the measure; and
p.001137: (ii) the views of other parties who also will use the quality measures (such as patients, consumers, and health
p.001137: care purchasers);
p.001137: (C) collaborate with the entity with a contract under section 1890(a) of the Social Security Act and other
p.001137: stake- holders, as practicable, and the Secretary so that quality measures developed by the eligible entity
p.001137: will meet the re- quirements to be considered for endorsement by the entity with a contract under such section 1890(a);
p.001137: (D) have transparent policies regarding governance and conflicts of interest; and
p.001137: (E) submit an application to the Secretary at such time and in such manner, as the Secretary may
p.001137: require.
p.001137: (4) USE OF FUNDS.—An entity that receives a grant, con- tract, or agreement under this subsection shall use
p.001137: such award to develop quality measures that meet the following require- ments:
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p.001137: (A) Such measures support measures required to be reported under the Social Security Act, where
p.001137: applicable, and in support of gaps and existing quality measures that need improvement, as described in subsection
p.001137: (b)(1)(A).
p.001137: (B) Such measures support measures developed under section 1139A of the Social Security Act and the Medicaid Quality
p.001137: Measurement Program under section 1139B of such Act, where applicable.
p.001137: As Amended Through P.L. 116-94, Enacted December 20, 2019 ...

p.001143: (f) COORDINATION.—The entities that receive a grant or con- tract under this section shall coordinate
p.001143: with health information technology regional extension centers under section 3012(c) and the primary care extension
p.001143: program established under section 399V–1 regarding the dissemination of quality improvement, system deliv-
p.001143: ery reform, and best practices information.
p.001143: SEC. 935. ø299b–35¿ GRANTS OR CONTRACTS TO IMPLEMENT MEDICA- TION MANAGEMENT SERVICES IN TREATMENT
p.001143: OF CHRONIC DISEASES.
p.001143: (a) IN GENERAL.—The Secretary, acting through the Patient Safety Research Center established in section
p.001143: 933 (referred to in this section as the ‘‘Center’’), shall establish a program to provide grants or
p.001143: contracts to eligible entities to implement medication management (referred to in this section as ‘‘MTM’’)
p.001143: services pro- vided by licensed pharmacists, as a collaborative, multidisciplinary, inter-professional approach to
p.001143: the treatment of chronic diseases for targeted individuals, to improve the quality of care and reduce overall
p.001143: cost in the treatment of such diseases. The Secretary shall commence the program under this section not
p.001143: later than May 1, 2010.
p.001143: (b) ELIGIBLE ENTITIES.—To be eligible to receive a grant or contract under subsection (a), an entity shall—
p.001143: (1) provide a setting appropriate for MTM services, as rec- ommended by the experts described in subsection (e);
p.001143: (2) submit to the Secretary a plan for achieving long-term financial sustainability;
p.001143: (3) where applicable, submit a plan for coordinating MTM services through local community health teams
p.001143: established in section 3502 of the Patient Protection and Affordable Care Act
p.001143: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001145: 1145
p.001145: PUBLIC HEALTH SERVICE ACT
p.001145: Sec. 935
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p.001145: or in collaboration with primary care extension programs es- tablished in section 399V–1;
p.001145: (4) submit a plan for meeting the requirements under sub- section (c); and
p.001145: (5) submit to the Secretary such other information as the Secretary may require.
p.001145: (c) MTM SERVICES TO TARGETED INDIVIDUALS.—The MTM services provided with the assistance of a grant or
p.001145: contract award- ed under subsection (a) shall, as allowed by State law including ap- plicable collaborative pharmacy
p.001145: practice agreements, include—
p.001145: (1) performing or obtaining necessary assessments of the health and functional status of each patient
p.001145: receiving such MTM services; ...

p.001147: on the informed patient choice among clinically appropriate treatment options.
p.001147: (c) ESTABLISHMENT OF INDEPENDENT STANDARDS FOR PATIENT DECISION AIDS FOR PREFERENCE SENSITIVE CARE.—
p.001147: (1) CONTRACT WITH ENTITY TO ESTABLISH STANDARDS AND CERTIFY PATIENT DECISION AIDS.—
p.001147: (A) IN GENERAL.—For purposes of supporting con- sensus-based standards for patient decision aids for
p.001147: pref- erence sensitive care and a certification process for patient decision aids for use in the Federal health
p.001147: programs and by other interested parties, the Secretary shall have in ef- fect a contract with the entity with
p.001147: a contract under sec- tion 1890 of the Social Security Act. Such contract shall provide that the entity
p.001147: perform the duties described in paragraph (2).
p.001147: (B) TIMING FOR FIRST CONTRACT.—As soon as prac- ticable after the date of the enactment of this section, the
p.001147: Secretary shall enter into the first contract under subpara- graph (A).
p.001147: (C) PERIOD OF CONTRACT.—A contract under subpara- graph (A) shall be for a period of 18 months (except
p.001147: such contract may be renewed after a subsequent bidding proc- ess).
p.001147: (2) DUTIES.—The following duties are described in this paragraph:
p.001147: (A) DEVELOP AND IDENTIFY STANDARDS FOR PATIENT DECISION AIDS.—The entity shall synthesize evidence and
p.001147: convene a broad range of experts and key stakeholders to develop and identify consensus-based standards
p.001147: to evalu- ate patient decision aids for preference sensitive care.
p.001147: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001147: Sec. 936 PUBLIC HEALTH SERVICE ACT 1148
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p.001147: (B) ENDORSE PATIENT DECISION AIDS.—The entity shall review patient decision aids and develop a certification
p.001147: process whether patient decision aids meet the standards developed and identified under subparagraph (A).
p.001147: The en- tity shall give priority to the review and certification of pa- tient decision aids for preference sensitive
p.001147: care.
p.001147: (d) PROGRAM TO DEVELOP, UPDATE AND PATIENT DECISION AIDS TO ASSIST HEALTH CARE PROVIDERS AND
p.001147: PATIENTS.—
p.001147: (1) IN GENERAL.—The Secretary, acting through the Direc- tor, and in coordination with heads of other relevant
p.001147: agencies, such as the Director of the Centers for Disease Control and Prevention and the Director of
p.001147: the National Institutes of Health, shall establish a program to award grants or con- tracts—
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p.001147: (A) to develop, update, and produce patient decision aids for preference sensitive care to assist health care
p.001147: pro- viders in educating patients, caregivers, and authorized representatives concerning the relative safety,
p.001147: relative ef- fectiveness (including possible health outcomes and impact on functional status), and relative cost
p.001147: of treatment or, where appropriate, palliative care options;
p.001147: (B) to test such materials to ensure such materials are balanced and evidence based in aiding health care pro-
p.001147: viders and patients, caregivers, and authorized representa- tives to make informed decisions about patient care
p.001147: and can be easily incorporated into a broad array of practice settings; and ...

p.001149: implementa- tion, and effective use of patient decision aids and shared decisionmaking by providers.
p.001149: (B) OBJECTIVES.—The objective of a Center is to en- hance and promote the adoption of patient decision
p.001149: aids and shared decisionmaking through—
p.001149: (i) providing assistance to eligible providers with the implementation and effective use of, and training
p.001149: on, patient decision aids; and
p.001149: (ii) the dissemination of best practices and re- search on the implementation and effective use of pa-
p.001149: tient decision aids.
p.001149: (3) SHARED DECISIONMAKING PARTICIPATION GRANTS.—
p.001149: (A) IN GENERAL.—The Secretary shall provide grants to health care providers for the development and
p.001149: imple- mentation of shared decisionmaking techniques and to as- sess the use of such techniques.
p.001149: (B) PREFERENCE.—In order to facilitate the use of best practices, the Secretary shall provide a preference in mak- ing
p.001149: grants under this subsection to health care providers who participate in training by Shared Decisionmaking Re-
p.001149: source Centers or comparable training.
p.001149: (C) LIMITATION.—Funds under this paragraph shall not be used to purchase or implement use of patient deci- sion
p.001149: aids other than those certified under the process iden- tified in subsection (c).
p.001149: (4) GUIDANCE.—The Secretary may issue guidance to eligi- ble grantees under this subsection on the use of
p.001149: patient deci- sion aids.
p.001149: (f) FUNDING.—For purposes of carrying out this section there are authorized to be appropriated such sums
p.001149: as may be necessary for fiscal year 2010 and each subsequent fiscal year.
p.001149: SEC. 937. ø299b–37¿ DISSEMINATION AND BUILDING CAPACITY FOR RE- SEARCH.
p.001149: (a) IN GENERAL.—
p.001149: (1) DISSEMINATION.—The Office of Communication and Knowledge Transfer (referred to in this section as the
p.001149: ‘‘Office’’) at the Agency for Healthcare Research and Quality (or any other relevant office designated by
p.001149: Agency for Healthcare Re-
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p.001149: Sec. 937 PUBLIC HEALTH SERVICE ACT 1150
p.001149:
p.001149: search and Quality), in consultation with the National Insti- tutes of Health, shall broadly disseminate
p.001149: the research find- ings that are published by the Patient Centered Outcomes Re- search Institute established under
p.001149: section 1181(b) of the Social Security Act (referred to in this section as the ‘‘Institute’’) and other
p.001149: government-funded research relevant to comparative clinical effectiveness research. The Office shall create
p.001149: informa- tional tools that organize and disseminate research findings for physicians, health care providers,
p.001149: patients, payers, and policy makers. The Office shall also develop a publicly available re- source
p.001149: database that collects and contains government-funded evidence and research from public, private, not-for
p.001149: profit, and academic sources.
p.001149: (2) REQUIREMENTS.—The Office shall provide for the dis- semination of the Institute’s research findings ...

p.001199: individual protection and advocacy systems within States to enable such systems to plan for, de- velop
p.001199: outreach strategies for, and carry out services authorized under this section for individuals with traumatic brain
p.001199: injury.
p.001199: (2) AMOUNT.—The amount of each grant provided under paragraph (1) shall be determined as set forth in
p.001199: paragraphs
p.001199: (2) and (3) of subsection (e).
p.001199: (e) APPROPRIATIONS OF $2,700,000 OR MORE.—
p.001199: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001199: Sec. 1253 PUBLIC HEALTH SERVICE ACT 1200
p.001199:
p.001199: (1) POPULATION BASIS.—Except as provided in paragraph (2), with respect to each fiscal year in which the amount
p.001199: appro- priated under subsection (l) to carry out this section is
p.001199: $2,700,000 or more, the Secretary shall make a grant to a pro- tection and advocacy system within each State.
p.001199: (2) AMOUNT.—The amount of a grant provided to a system under paragraph (1) shall be equal to an amount bearing
p.001199: the same ratio to the total amount appropriated for the fiscal year involved under subsection (l) as the population of
p.001199: the State in which the grantee is located bears to the population of all States.
p.001199: (3) MINIMUMS.—Subject to the availability of appropria- tions, the amount of a grant a protection and advocacy
p.001199: system under paragraph (1) for a fiscal year shall—
p.001199: (A) in the case of a protection and advocacy system lo- cated in American Samoa, Guam, the United States Virgin
p.001199: Islands, or the Commonwealth of the Northern Mariana Islands, and the protection and advocacy system
p.001199: serving the American Indian consortium, not be less than $20,000; and
p.001199: (B) in the case of a protection and advocacy system in a State not described in subparagraph (A), not be less than
p.001199: $50,000.
p.001199: (4) INFLATION ADJUSTMENT.—For each fiscal year in which the total amount appropriated under subsection (l) to carry
p.001199: out this section is $5,000,000 or more, and such appropriated amount exceeds the total amount
p.001199: appropriated to carry out this section in the preceding fiscal year, the Secretary shall in- crease each of the
p.001199: minimum grants amount described in sub- paragraphs (A) and (B) of paragraph (3) by a percentage equal to the
p.001199: percentage increase in the total amount appropriated under subsection (l) to carry out this section
p.001199: between the pre- ceding fiscal year and the fiscal year involved.
p.001199: (f) CARRYOVER.—Any amount paid to a protection and advocacy system that serves a State or the American Indian
p.001199: consortium for a fiscal year under this section that remains unobligated at the end of such fiscal year shall remain
p.001199: available to such system for obliga- tion during the next fiscal year for the purposes for which such amount
p.001199: was originally provided.
p.001199: (g) DIRECT PAYMENT.—Notwithstanding any other provision of law, each fiscal year not later than October
p.001199: 1, the Secretary shall pay directly to any protection and advocacy system that complies with the
p.001199: provisions of this section, the total amount of the grant for such system, unless the system provides
p.001199: otherwise for such pay- ment.
p.001199: (h) REPORTING.— 2
p.001199: (1) REPORTS BY SYSTEMS.—Each protection and advocacy system that receives a payment under this section shall
p.001199: submit an annual report to the Secretary concerning the services pro-
p.001199:
p.001199:
p.001199:
p.001199:
p.001199:
p.001199: January 30, 2020
p.001199: 2 The formatting of heading of subsection (h), as amended by section 4(3) of Public Law 113– 196, reflects the
p.001199: probable intent of Congress. The matter being inserted should have appeared in light typeface with an
p.001199: initial cap and small caps letters. Also, a period and a dash should have been included at the end.
p.001199: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001199:
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p.001201: 1201
p.001201: PUBLIC HEALTH SERVICE ACT
p.001201: Sec. 1254
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p.001201:
p.001201: January 30, 2020
p.001201: vided to individuals with traumatic brain injury by such sys- tem.
p.001201: (2) REPORT BY SECRETARY.—Not later than 1 year after the date of enactment of the Traumatic Brain Injury Reauthoriza- ...

p.001217: out enrollment of members who are entitled to medical assistance under a State plan approved under title XIX of the
p.001217: Social Security Act in ac- cordance with procedures approved under regulations promul- gated by the Secretary;
p.001217: (4) not expel or refuse to re-enroll any member because of his health status or his requirements for health services;
p.001217: (5) be organized in such a manner that provides meaning- ful procedures for hearing and resolving grievances
p.001217: between the health maintenance organization (including the medical group or groups and other health
p.001217: delivery entities providing health services for the organization) and the members of the organization;
p.001217: (6) have organizational arrangements, established in ac- cordance with regulations of the Secretary, for
p.001217: an ongoing quality assurance program for its health services which pro- gram (A) stresses health outcomes, and
p.001217: (B) provides review by physicians and other health professionals of the process fol- lowed in the provision of
p.001217: health services;
p.001217: (7) adopt at least one of the following arrangements to pro- tect its members from incurring liability for
p.001217: payment of any fees which are the legal obligation of such organization—
p.001217: (A) a contractual arrangement with any hospital that is regularly used by the members of such organization pro-
p.001217: hibiting such hospital from holding any such member lia- ble for payment of any fees which are the
p.001217: legal obligation of such organization;
p.001217: (B) insolvency insurance, acceptable to the Secretary;
p.001217: (C) adequate financial reserve, acceptable to the Sec- retary; and
p.001217: (D) other arrangements, acceptable to the Secretary, to protect members,
p.001217: except that the requirements of this paragraph shall not apply to a health maintenance organization if
p.001217: applicable State law provides the members of such organization with protection from liability for payment of any fees
p.001217: which are the legal obligation of such organi- zation; and
p.001217: (8) provide, in accordance with regulations of the Secretary (in- cluding safeguards concerning the confidentiality
p.001217: of the doctor-pa- tient relationship), an effective procedure for developing, compiling, evaluating, and reporting
p.001217: to the Secretary, statistics and other in- formation (which the Secretary shall publish and disseminate
p.001217: on an annual basis and which the health maintenance organization
p.001217: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001217:
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p.001217:
p.001219: 1219
p.001219: PUBLIC HEALTH SERVICE ACT
p.001219: Sec. 1302
p.001219:
p.001219: shall disclose, in a manner acceptable to the Secretary, to its mem- bers and the general public) relating to
p.001219: (A) the cost of its oper- ations, (B) the patterns of utilization of its services, (C) the avail-
p.001219: ability, accessibility, and acceptability of its services, (D) to the ex- tent practical, developments in the
p.001219: health status of its members, and (E) such other matters as the Secretary may require.
p.001219: The Secretary shall issue regulations stating the circumstances under which the Secretary, in administering
p.001219: paragraph (1)(A), will consider the resources of an organization which owns or controls a health maintenance
p.001219: organization. Such regulations shall require as a condition to consideration of resources that an organization which
p.001219: owns or controls a health maintenance organization shall provide satisfactory assurances that it will assume
p.001219: the financial obligations of the health maintenance organization.
p.001219: (d) An organization that offers health benefits coverage shall not be considered as failing to meet the ...

p.001225: prescribe. Each such report shall contain,
p.001225: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001225:
p.001225:
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p.001225: Sec. 1308 PUBLIC HEALTH SERVICE ACT 1226
p.001225: among such other matters as the Secretary may by regulation re- quire, descriptions of plans,
p.001225: developments, and operations relating to the matters referred to in section 1306(b)(3).
p.001225: (d) 2 An entity which provides health services to a defined pop- ulation on a prepaid basis and which has
p.001225: members who are enti- tled to insurance benefits under title XVIII of the Social Security Act or to
p.001225: medical assistance under a State plan approved under title XIX of such Act may be considered as a
p.001225: health maintenance organization for purposes of receiving assistance under this title if—
p.001225: (1) with respect to its members who are entitled to such insurance benefits or to such medical assistance it
p.001225: (A) provides health services in accordance with section 1301(b), except that
p.001225: (i) it does not furnish to those members the health services (within the basic health services) for which it
p.001225: may not be com- pensated under such title XVIII or such State plan, and (ii) it does not fix the basic or
p.001225: supplemental health services payment for such members under a community rating system, and (B) is organized
p.001225: and operated in the manner prescribed by section 1301(c), except that it does not assume full financial risk on a
p.001225: prospective basis for the provision to such members of basic or supplemental health services with respect to which it
p.001225: is not re- quired under such title XVIII or such State plan to assume such financial risk; and
p.001225: (2) with respect to its other members it provides health services in accordance with section 1301(b) and
p.001225: is organized and operated in the manner prescribed by section 1301(c).
p.001225: An entity which provides health services to a defined population on a prepaid basis and which has members who
p.001225: are enrolled under the health benefits program authorized by chapter 89 of title 5, United States Code, may
p.001225: be considered as a health maintenance or- ganization for purposes of receiving assistance under this title if
p.001225: with respect to its other members it provides health services in ac- cordance with section 1301(b) and is organized and
p.001225: operated in the manner prescribed by section 1301(c).
p.001225:
p.001225: GENERAL PROVISIONS RELATING TO LOAN GUARANTEES AND LOANS
p.001225: SEC. 1308. ø300e–7¿ (a)(1) The Secretary may not approve an application for a loan guarantee under this
p.001225: title unless he deter- mines that (A) the terms, conditions, security (if any), and schedule and amount of
p.001225: repayments with respect to the loan are sufficient to protect the financial interests of the United States and
p.001225: are oth- erwise reasonable, including a determination that the rate of inter- est does not exceed such per centum
p.001225: per annum on the principal obligation outstanding as the Secretary determines to be reason- able, taking
p.001225: into account the range of interest rates prevailing in the private market for loans with similar maturities,
p.001225: terms, condi- tions, and security and the risks assumed by the United States, and (B) the loan would not
p.001225: be available on reasonable terms and conditions without the guarantee under this title.
p.001225: (2)(A) The United States shall be entitled to recover from the applicant for a loan guarantee under
p.001225: this title the amount of any
p.001225:
p.001225:
p.001225:
p.001225: January 30, 2020
p.001225: 2 Former subsection (c) was repealed by section 803(a) of Public Law 99–660.
p.001225: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001225:
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p.001227: 1227
p.001227: PUBLIC HEALTH SERVICE ACT
p.001227: Sec. 1308
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p.001233: (4) for loans, or for payments under loan guarantees, to as- sist in meeting the costs of the initial operation after
p.001233: establish- ment or expansion of such organizations or entities or in meet- ing the costs of such organizations in
p.001233: acquiring or constructing ambulatory health care facilities.
p.001233: ANNUAL REPORT
p.001233: SEC. 1315. ø300e–14¿ (a) The Secretary shall periodically re- view the programs of assistance authorized by
p.001233: this title and make an annual report to the Congress of a summary of the activities under each program.
p.001233: The Secretary shall include in such sum- mary—
p.001233:
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p.001233:
p.001233: January 30, 2020
p.001233: (1) a summary of each grant, contract, loan, or loan guar- antee made under this title in the period covered by the
p.001233: report and a list of the health maintenance organizations which dur- ing such period became qualified health
p.001233: maintenance organiza- tions for purposes of section 1310;
p.001233: (2) the statistics and other information reported in such period to the Secretary in accordance with
p.001233: section 1301(c)(11);
p.001233: (3) findings with respect to the ability of the health main- tenance organizations assisted under this title—
p.001233: (A) to operate on a fiscally sound basis without contin- ued Federal financial assistance,
p.001233: (B) to meet the requirements of section 1301(c) re- specting their organization and operation,
p.001233: (C) to provide basic and supplemental health services in the manner prescribed by section 1301(b),
p.001233: (D) to include indigent and high-risk individuals in their membership, and
p.001233: (E) to provide services to medically underserved popu- lations; and
p.001233: (4) findings with respect to—
p.001233: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001233:
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p.001235: 1235
p.001235: PUBLIC HEALTH SERVICE ACT
p.001235: Sec. 1317
p.001235:
p.001235: (A) the operation of distinct categories of health main- tenance organizations in comparison with each other,
p.001235: (B) health maintenance organizations as a group in comparison with alternative forms of health care delivery,
p.001235: and
p.001235: (C) the impact that health maintenance organizations, individually, by category, and as a group, have on the
p.001235: health of the public.
p.001235: (b) The Office of Management and Budget may review the Sec- retary’s report under subsection (a) before its
p.001235: submission to the Congress, but the Office may not revise the report or delay its sub- mission, and it may submit
p.001235: to the Congress its comments (and those of other departments or agencies of the Government) respect- ing such
p.001235: report.
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p.001235: January 30, 2020 ...

p.001265: arrangements have been made and that they are satisfactory.
p.001265: (d) The records and audits requirements of section 705 shall apply with respect to grants made under
p.001265: subsection (a).
p.001265: (e) For purposes of this part, the term ‘‘hospital’’ means, with respect to any fiscal year, an
p.001265: institution (including a distinct part of an institution participating in the programs established under
p.001265: title XVIII of the Social Security Act)—
p.001265: (1) which satisfies paragraphs (1) and (7) of section 1861(e) of such Act,
p.001265: (2) imposes charges or accepts payments for services pro- vided to patients, and
p.001265: (3) the average duration of a patient’s stay in which was thirty days or less in the preceding fiscal year,
p.001265: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001265:
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p.001265: Sec. 1643 PUBLIC HEALTH SERVICE ACT 1266
p.001265:
p.001265: but such term does not include a Federal hospital or a psychiatric hospital (as described in section 1861(f)(1)
p.001265: of the Social Security Act).
p.001265: GRANTS TO STATES FOR REDUCTION OF EXCESS HOSPITAL CAPACITY
p.001265: SEC. 1643. ø300t–13¿ (a) For the purpose of demonstrating the effectiveness of various means for reducing
p.001265: excesses in resources and facilities of hospitals (referred to in this section as ‘‘excess hos- pital capacity’’),
p.001265: the Secretary may make grants to State Agencies designated under section 1521(b)(3) to assist such Agencies in—
p.001265: (1) identifying (by geographic region or by health service) excess hospital capacity,
p.001265: (2) developing programs to inform the public of the costs associated with excess hospital capacity,
p.001265: (3) developing programs to reduce excess hospital capacity in a manner which will produce the greatest savings
p.001265: in the cost of health care delivery,
p.001265: (4) developing means to overcome barriers to the reduction of excess hospital capacity,
p.001265: (5) in planning, evaluating, and carrying out programs to decertify health care facilities providing
p.001265: health services that are not appropriate, and
p.001265: (6) any other activity related to the reduction of excess hospital capacity.
p.001265: (b) Grants under subsection (a) shall be made on such terms and conditions as the Secretary may prescribe.
p.001265: AUTHORIZATION OF APPROPRIATIONS
p.001265: SEC. 1644. ø300t–14¿ To make payments under grants under sections 1642 and 1643 there are authorized to
p.001265: be appropriated
p.001265: $30,000,000 for the fiscal year ending September 30, 1980,
p.001265: $50,000,000 for the fiscal year ending September 30, 1981, and
p.001265: $75,000,000 for the fiscal year ending September 30, 1982, except that in any fiscal year not more than 10
p.001265: percent of the amount ap- propriated under this section may be obligated for grants under section 1643.
p.001265: TITLE XVII—HEALTH INFORMATION AND HEALTH PROMOTION
p.001265:
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p.001281: recommendation from the Commission that the agency take any action with respect to its rules, policies,
p.001281: guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall
p.001281: provide op- portunity for interested persons to submit written data, views, and arguments with respect to adoption of
p.001281: the recommendation.
p.001281: (2) Within the 180-day period beginning on the date of such publication, the agency shall determine
p.001281: whether the action pro- posed by such recommendation is appropriate, and, to the extent that it determines
p.001281: that—
p.001281: (A) such action is not appropriate, the agency shall, within such time period, provide the Commission with, and publish
p.001281: in
p.001281:
p.001281:
p.001281:
p.001281:
p.001281: January 30, 2020
p.001281: 2 So in law. Probably should be ‘‘contained’’.
p.001281: 3 So in law. The comma should probably be a semicolon.
p.001281: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001281:
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p.001283: 1283
p.001283: PUBLIC HEALTH SERVICE ACT
p.001283: Sec. 1803
p.001283:
p.001283: the Federal Register, a notice of such determination (including an adequate statement of the reasons for the
p.001283: determination), or
p.001283: (B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and shall
p.001283: notify the Commission of the determination and the action undertaken.
p.001283: (c) REPORT ON PROTECTION OF HUMAN SUBJECTS.—The Com- mission shall biennially report to the President, the
p.001283: Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral
p.001283: research. Each such report shall in- clude a review of the adequacy and uniformity (1) of the rules, poli- cies,
p.001283: guidelines, and regulations of all Federal agencies regarding the protection of human subjects of
p.001283: biomedical or behavioral re- search which such agencies conduct or support, and (2) of the im-
p.001283: plementation of such rules, policies, guidelines, and regulations by such agencies, and may include such
p.001283: recommendations for legisla- tion and administrative action as the Commission deems appro- priate.
p.001283: (d) ANNUAL REPORT.—Not later than December 15 of each year (beginning with 1979) the Commission shall report to
p.001283: the Presi- dent, the Congress, and appropriate Federal agencies on the activi- ties of the Commission during the
p.001283: fiscal year ending in such year. Each such report shall include a complete list of all recommenda- tions
p.001283: described in subsection (b)(1) made to Federal agencies by the Commission during the fiscal year and the actions taken,
p.001283: pursant 4 to subsection (b)(2), by the agencies upon such recommendations, and may include such recommendations
p.001283: for legislation and admin- istrative action as the Commission deems appropriate.
p.001283: (e) PUBLICATIONS.—The Commission may at any time publish and disseminate to the public reports respecting its
p.001283: activities.
p.001283: (f) DEFINITIONS.—For purposes of this section: ...

p.001327: the grant, com- ply with chapter 75 of title 31, United States Code.
p.001327: (c) AVAILABILITY TO PUBLIC.—A funding agreement for a grant under section 1911 or 1921 is that the State involved will—
p.001327: (1) make copies of the reports and audits described in this section available for public inspection within the State;
p.001327: and
p.001327: (2) provide copies of the report under subsection (a), upon request, to any interested person (including any
p.001327: public agency).
p.001327: SEC. 1943. ø300x–53¿ ADDITIONAL REQUIREMENTS.
p.001327: (a) IN GENERAL.—A funding agreement for a grant under sec- tion 1911 or 1921 is that the State involved will—
p.001327: (1)(A) for the fiscal year for which the grant involved is provided, provide for independent peer review
p.001327: to assess the quality, appropriateness, and efficacy of treatment services provided in the State to
p.001327: individuals under the program in- volved; and
p.001327: (B) ensure that, in the conduct of such peer review, not fewer than 5 percent of the entities
p.001327: providing services in the State under such program are reviewed (which 5 percent is representative of the
p.001327: total population of such entities);
p.001327: (2) permit and cooperate with Federal investigations un- dertaken in accordance with section 1945; and
p.001327: (3) provide to the Secretary any data required by the Sec- retary pursuant to subsections (c) and (d) of
p.001327: section 505 and will cooperate with the Secretary in the development of uni- form criteria for the
p.001327: collection of data pursuant to such section.
p.001327: (b) PATIENT RECORDS.—The Secretary may make a grant under section 1911 or 1921 only if the State involved has in effect
p.001327: a sys- tem to protect from inappropriate disclosure patient records main- tained by the State in connection with an
p.001327: activity funded under the program involved or by any entity which is receiving amounts from the grant.
p.001327:
p.001327: January 30, 2020 As Amended Through P.L. 116-94,
p.001327: Enacted December 20, 2019
p.001327:
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p.001327:
p.001327:
p.001329: 1329
p.001329: PUBLIC HEALTH SERVICE ACT
p.001329: Sec. 1945
p.001329:
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p.001329:
p.001329: January 30, 2020
p.001329: SEC. 1944. ø300x–54¿ DISPOSITION OF CERTAIN FUNDS APPROPRIATED FOR ALLOTMENTS.
p.001329: (a) IN GENERAL.—Amounts described in subsection (b) and available for a fiscal year pursuant to section 1911 or
p.001329: 1921, as the case may be, shall be allotted by the Secretary and paid to the States receiving a grant
p.001329: under the program involved, other than any State referred to in subsection (b) with respect to such ...

p.001407: vide for the continuous collection of data on the incidence in the United States of cases of acquired immune
p.001407: deficiency syn- drome and of cases of infection with the etiologic agent for such syndrome. The Secretary may carry
p.001407: out the program of data collection directly or through cooperative agreements and con- tracts with public
p.001407: and nonprofit private entities.
p.001407: (2) The Secretary shall encourage each State to enter into a cooperative agreement or contract under paragraph
p.001407: (1) with the Secretary in order to facilitate the prompt collection of the most recent accurate data on the
p.001407: incidence of cases described in such paragraph.
p.001407: (3) The Secretary shall ensure that data collected under paragraph (1) includes data on the demographic
p.001407: characteristics of the population of individuals with cases described in para- graph (1), including data
p.001407: on specific subpopulations at risk of infection with the etiologic agent for acquired immune defi- ciency
p.001407: syndrome.
p.001407: (4) In carrying out this subsection, the Secretary shall, for the purpose of assuring the utility of data collected
p.001407: under this section, request entities with expertise in the methodologies of data collection to provide, as soon
p.001407: as is practicable, assistance to the Secretary and to the States with respect to the develop- ment and utilization
p.001407: of uniform methodologies of data collec- tion.
p.001407: (5) The Secretary shall provide for the dissemination of data collected pursuant to this subsection. In
p.001407: carrying out this paragraph, the Secretary may publish such data as frequently as the Secretary determines to be
p.001407: appropriate with respect to the protection of the public health. The Secretary shall publish such data not less than
p.001407: once each year.
p.001407: (b) EPIDEMIOLOGICAL AND DEMOGRAPHIC DATA.—
p.001407: (1) The Secretary, acting through the Director of the Cen- ters for Disease Control and Prevention, shall
p.001407: develop an epi- demiological data base and shall provide for long-term studies for the purposes of—
p.001407: (A) collecting information on the demographic charac- teristics of the population of individuals infected
p.001407: with the etiologic agent for acquired immune deficiency syndrome and the natural history of such infection; and
p.001407: (B) developing models demonstrating the long-term do- mestic and international patterns of the transmission of
p.001407: such etiologic agent.
p.001407: (2) The Secretary may carry out paragraph (1) directly or through grants to, or cooperative agreeements 4
p.001407: or contracts with, public and nonprofit private entities, including Federal agencies.
p.001407: (c) LONG-TERM RESEARCH.—The Secretary may make grants to public and nonprofit private entities for the purpose
p.001407: of assisting grantees in conducting long-term research into treatments for ac- quired immune deficiency
p.001407: syndrome developed from knowledge of the genetic nature of the etiologic agent for such syndrome.
p.001407:
p.001407:
p.001407:
p.001407: January 30, 2020
p.001407: 4 So in law. Probably should be ‘‘agreements’’.
p.001407: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001407:
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p.001409: 1409
p.001409: PUBLIC HEALTH SERVICE ACT
p.001409: Sec. 2341
p.001409:
p.001409: (d) SOCIAL SCIENCES RESEARCH.—The Secretary, acting through the Director of the National Institute
p.001409: of Mental Health, may make grants to public and nonprofit private entities for the purpose of assisting
p.001409: grantees in conducting scientific research into the psychological and social sciences as such sciences relate
p.001409: to ac- quired immune deficiency syndrome.
p.001409: (e) AUTHORIZATION OF APPROPRIATIONS.—
p.001409: (1) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be ...

p.001409: amended by striking ‘‘Centers for Disease Control’’ and inserting ‘‘Centers for Disease Control and Prevention’’.
p.001409: The amendment cannot be executed because it does not specify to which of the instances of such term the
p.001409: amendment applies.
p.001409: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001409:
p.001409:
p.001409:
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p.001409: Sec. 2351 PUBLIC HEALTH SERVICE ACT 1410
p.001409:
p.001409: PART D—OFFICE OF AIDS RESEARCH
p.001409: Subpart I—Interagency Coordination of Activities
p.001409: SEC. 2351. ø300cc–40¿ ESTABLISHMENT OF OFFICE.
p.001409: (a) IN GENERAL.—There is established within the National In- stitutes of Health an office to be known as the
p.001409: Office of AIDS Re- search. The Office shall be headed by a director, who shall be ap- pointed by the
p.001409: Secretary.
p.001409: (b) DUTIES.—
p.001409: (1) INTERAGENCY COORDINATION OF AIDS ACTIVITIES.—With respect to acquired immune deficiency syndrome, the
p.001409: Director of the Office shall plan, coordinate, and evaluate research and other activities conducted or supported
p.001409: by the agencies of the National Institutes of Health. In carrying out the preceding sentence, the Director
p.001409: of the Office shall evaluate the AIDS ac- tivities of each of such agencies and shall provide for the peri- odic
p.001409: reevaluation of such activities.
p.001409: (2) CONSULTATIONS.—The Director of the Office shall carry out this subpart (including developing and revising the plan
p.001409: re- quired in section 2353) in consultation with the heads of the agencies of the National Institutes of
p.001409: Health, with the advisory councils of the agencies, and with the advisory council estab- lished under section
p.001409: 2352.
p.001409: (3) COORDINATION.—The Director of the Office shall act as the primary Federal official with responsibility for
p.001409: overseeing all AIDS research conducted or supported by the National In- stitutes of Health, and
p.001409: (A) shall serve to represent the National Institutes of Health AIDS Research Program at all relevant
p.001409: Executive branch task forces and committees; and
p.001409: (B) shall maintain communications with all relevant Public Health Service agencies and with various other de-
p.001409: partments of the Federal Government, to ensure the time- ly transmission of information concerning advances
p.001409: in AIDS research and the clinical treatment of acquired im- mune deficiency syndrome and its related
p.001409: conditions, be- tween these various agencies for dissemination to affected communities and health care providers.
p.001409: SEC. 2351A. ø300cc–40a¿ MICROBICIDE RESEARCH.
p.001409: (a) FEDERAL STRATEGIC PLAN.—The Director of the Office shall—
p.001409:
p.001409:
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p.001409:
p.001409:
p.001409: January 30, 2020
p.001409: (1) expedite the implementation of the Federal strategic plans required by section 403(a) of the Public
p.001409: Health Service Act (42 U.S.C. 283(a)(5)) regarding the conduct and support of research on, and development of, a
p.001409: microbicide to prevent the transmission of the human immunodeficiency virus; and ...

p.001435: 3 See footnote for section 217(a).
p.001435:
p.001435: As Amended Through P.L. 116-94, Enacted December 20, 2019
p.001435:
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p.001435: Sec. 2507 PUBLIC HEALTH SERVICE ACT 1436
p.001435:
p.001435: tinuing relationships, with a portion of the population in the service area that is at risk of
p.001435: infection with the etio- logic agent for acquired immune deficiency syndrome and with public and private
p.001435: entities in such area that provide health or other support services to individuals with such infection;
p.001435: (D) to provide a description of—
p.001435: (i) the objectives established by the applicant for the conduct of the program; and
p.001435: (ii) the methods the applicant will use to evaluate the activities conducted under the program to deter- mine if
p.001435: such objectives are met; and
p.001435: (E) such other information as the Secretary may pre- scribe;
p.001435: (7) with respect to programs carried out pursuant to sec- tion 2502(10), the State will give preference
p.001435: to any applicant for a grant pursuant to such section that is located in, has a history of service in,
p.001435: and will serve under the program, any ge- ographic area in which—
p.001435: (A) there is a significant incidence of acquired immune deficiency syndrome;
p.001435: (B) there has been a significant increase in the inci- dence of such syndrome; or
p.001435: (C) there is a significant risk of becoming infected with the etiologic agent for such syndrome;
p.001435: (8) the State will establish reasonable criteria to evaluate the effective performance of entities that
p.001435: receive funds from payments made to the State under section 2501(a) and will es- tablish procedures for procedural
p.001435: and substantive independent State review of the failure by the State to provide funds for any such entity;
p.001435: (9) the State will permit and cooperate with Federal inves- tigations undertaken in accordance with section 2508(e);
p.001435: (10) the State will maintain State expenditures for services provided pursuant to section 2501 at a level equal
p.001435: to not less than the average level of such expenditures maintained by the State for the 2-year period preceding
p.001435: the fiscal year for which the State is applying to receive payments.
p.001435: (b) DEFINITION.—For purposes of subsection (a)(5), the term ‘‘significant percentage’’ means at least a
p.001435: percentage of 1 percent of the number of reported cases of acquired immune deficiency syn- drome in the United
p.001435: States.
p.001435: SEC. 2507. ø300ee–17¿ DETERMINATION OF AMOUNT OF ALLOTMENTS FOR STATES.
p.001435: (a) MINIMUM ALLOTMENT.—Subject to the extent of amounts made available in appropriation Acts, the
p.001435: allotment for a State under section 2501(a) for a fiscal year shall be the greater of—
p.001435: (1) the applicable amount specified in subsection (b); or
p.001435: (2) the amount determined in accordance with subsection
p.001435:
p.001435:
p.001435:
p.001435:
p.001435:
p.001435: January 30, 2020
p.001435: (c).
p.001435: (b) DETERMINATION OF MINIMUM ALLOTMENT.—
p.001435: (1) If the total amount appropriated under section 2514(a) for a fiscal year exceeds $100,000,000, the amount ...

p.001541: plan or coverage or, if earlier, the first day of the waiting period for such enrollment.
p.001541: (3) LATE ENROLLEE.—The term ‘‘late enrollee’’ means, with respect to coverage under a group health plan, a participant
p.001541: or beneficiary who enrolls under the plan other than during—
p.001541: (A) the first period in which the individual is eligible to enroll under the plan, or
p.001541: (B) a special enrollment period under subsection (f).
p.001541: (4) WAITING PERIOD.—The term ‘‘waiting period’’ means, with respect to a group health plan and an
p.001541: individual who is a potential participant or beneficiary in the plan, the period that must pass with
p.001541: respect to the individual before the indi- vidual is eligible to be covered for benefits under the
p.001541: terms of the plan.
p.001541: (c) RULES RELATING TO CREDITING PREVIOUS COVERAGE.—
p.001541: (1) CREDITABLE COVERAGE DEFINED.—For purposes of this title, the term ‘‘creditable coverage’’ means, with respect
p.001541: to an individual, coverage of the individual under any of the fol- lowing:
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p.001541: January 30, 2020
p.001541: (A) A group health plan.
p.001541: (B) Health insurance coverage.
p.001541: (C) Part A or part B of title XVIII of the Social Secu- rity Act.
p.001541: (D) Title XIX of the Social Security Act, other than coverage consisting solely of benefits under section
p.001541: 1928.
p.001541: (E) Chapter 55 of title 10, United States Code.
p.001541: (F) A medical care program of the Indian Health Serv- ice or of a tribal organization.
p.001541: (G) A State health benefits risk pool.
p.001541: (H) A health plan offered under chapter 89 of title 5, United States Code.
p.001541: (I) A public health plan (as defined in regulations).
p.001541: (J) A health benefit plan under section 5(e) of the Peace Corps Act (22 U.S.C. 2504(e)).
p.001541: Such term does not include coverage consisting solely of cov- erage of excepted benefits (as defined in
p.001541: section 2791(c)).
p.001541: (2) NOT COUNTING PERIODS BEFORE SIGNIFICANT BREAKS IN COVERAGE.—
p.001541: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001543: 1543
p.001543: PUBLIC HEALTH SERVICE ACT
p.001543: Sec. 2704
p.001543:
p.001543: (A) IN GENERAL.—A period of creditable coverage shall not be counted, with respect to enrollment of an individual under
p.001543: a group or individual health plan, if, after such pe- riod and before the enrollment date, there was a 63-day
p.001543: period during all of which the individual was not covered under any creditable coverage.
p.001543: (B) WAITING PERIOD NOT TREATED AS A BREAK IN COV- ERAGE.—For purposes of subparagraph (A) and subsection
p.001543: (d)(4), any period that an individual is in a waiting period for any coverage under a group or individual
p.001543: health plan (or for group health insurance coverage) or is in an affili- ation period (as defined in
p.001543: subsection (g)(2)) shall not be taken into account in determining the continuous period under subparagraph
p.001543: (A). ...

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p.001555: January 30, 2020
p.001555: with all applicable regulations, and that is operating on such date, from continuing to be carried out for as
p.001555: long as such regulations remain in effect.
p.001555: (l) WELLNESS PROGRAM DEMONSTRATION PROJECT.—
p.001555: (1) IN GENERAL.—Not later than July 1, 2014, the Sec- retary, in consultation with the Secretary of the
p.001555: Treasury and the Secretary of Labor, shall establish a 10-State demonstra- tion project under which
p.001555: participating States shall apply the provisions of subsection (j) to programs of health promotion of- fered by a
p.001555: health insurance issuer that offers health insurance coverage in the individual market in such State.
p.001555: (2) EXPANSION OF DEMONSTRATION PROJECT.—If the Sec- retary, in consultation with the Secretary of the Treasury
p.001555: and the Secretary of Labor, determines that the demonstration project described in paragraph (1) is effective,
p.001555: such Secretaries may, beginning on July 1, 2017 expand such demonstration project to include additional
p.001555: participating States.
p.001555: (3) REQUIREMENTS.—
p.001555: (A) MAINTENANCE OF COVERAGE.—The Secretary, in consultation with the Secretary of the Treasury and the
p.001555: Secretary of Labor, shall not approve the participation of a State in the demonstration project under this
p.001555: section un- less the Secretaries determine that the State’s project is designed in a manner that—
p.001555: (i) will not result in any decrease in coverage; and
p.001555: (ii) will not increase the cost to the Federal Gov- ernment in providing credits under section 36B of the
p.001555: Internal Revenue Code of 1986 or cost-sharing assist- ance under section 1402 of the Patient Protection and
p.001555: Affordable Care Act.
p.001555: (B) OTHER REQUIREMENTS.—States that participate in the demonstration project under this subsection—
p.001555: (i) may permit premium discounts or rebates or the modification of otherwise applicable copayments or
p.001555: deductibles for adherence to, or participation in, a rea- sonably designed program of health promotion and
p.001555: disease prevention;
p.001555: (ii) shall ensure that requirements of consumer protection are met in programs of health promotion in the
p.001555: individual market;
p.001555: (iii) shall require verification from health insur- ance issuers that offer health insurance coverage in
p.001555: the individual market of such State that premium dis- counts—
p.001555: (I) do not create undue burdens for individ- uals insured in the individual market;
p.001555: (II) do not lead to cost shifting; and
p.001555: (III) are not a subterfuge for discrimination;
p.001555: (iv) shall ensure that consumer data is protected in accordance with the requirements of section 264(c)
p.001555: of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note); and
p.001555: (v) shall ensure and demonstrate to the satisfac- tion of the Secretary that the discounts or other re-
p.001555: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001563: (ii) other benefits, as identified by the Secretary;
p.001563: (C) the exceptions, reductions, and limitations on cov- erage;
p.001563: (D) the cost-sharing provisions, including deductible, coinsurance, and co-payment obligations;
p.001563: (E) the renewability and continuation of coverage pro- visions;
p.001563: (F) a coverage facts label that includes examples to il- lustrate common benefits scenarios, including pregnancy
p.001563: and serious or chronic medical conditions and related cost sharing, such scenarios to be based on recognized
p.001563: clinical practice guidelines;
p.001563: (G) a statement of whether the plan or coverage—
p.001563: (i) provides minimum essential coverage (as de- fined under section 5000A(f) of the Internal Revenue Code
p.001563: 1986); and
p.001563: (ii) ensures that the plan or coverage share of the total allowed costs of benefits provided under the plan or
p.001563: coverage is not less than 60 percent of such costs;
p.001563: (H) a statement that the outline is a summary of the policy or certificate and that the coverage
p.001563: document itself should be consulted to determine the governing contrac- tual provisions; and
p.001563: (I) a contact number for the consumer to call with ad- ditional questions and an Internet web address where a
p.001563: copy of the actual individual coverage policy or group cer- tificate of coverage can be reviewed and obtained.
p.001563: (c) PERIODIC REVIEW AND UPDATING.—The Secretary shall peri- odically review and update, as appropriate, the
p.001563: standards devel- oped under this section.
p.001563: (d) REQUIREMENT TO PROVIDE.—
p.001563: (1) IN GENERAL.—Not later than 24 months after the date of enactment of the Patient Protection and Affordable
p.001563: Care Act, each entity described in paragraph (3) shall provide, prior to any enrollment restriction, a summary of
p.001563: benefits and cov- erage explanation pursuant to the standards developed by the Secretary under subsection
p.001563: (a) to—
p.001563: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001563: Sec. 2715 PUBLIC HEALTH SERVICE ACT 1564
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p.001563: January 30, 2020
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p.001563: (A) an applicant at the time of application;
p.001563: (B) an enrollee prior to the time of enrollment or re- enrollment, as applicable; and
p.001563: (C) a policyholder or certificate holder at the time of issuance of the policy or delivery of the certificate.
p.001563: (2) COMPLIANCE.—An entity described in paragraph (3) is deemed to be in compliance with this section if ...

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p.001565: Sec. 2717 PUBLIC HEALTH SERVICE ACT 1566
p.001565: (C) implement activities to improve patient safety and reduce medical errors through the appropriate use of
p.001565: best clinical practices, evidence based medicine, and health in- formation technology under the plan or
p.001565: coverage; and
p.001565: (D) implement wellness and health promotion activi-
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p.001565: January 30, 2020
p.001565: ties.
p.001565: (2) REPORTING REQUIREMENTS.—
p.001565: (A) IN GENERAL.—A group health plan and a health in- surance issuer offering group or individual health insur-
p.001565: ance coverage shall annually submit to the Secretary, and to enrollees under the plan or coverage, a report on wheth-
p.001565: er the benefits under the plan or coverage satisfy the ele- ments described in subparagraphs (A) through (D)
p.001565: of para- graph (1).
p.001565: (B) TIMING OF REPORTS.—A report under subpara- graph (A) shall be made available to an enrollee under the
p.001565: plan or coverage during each open enrollment period.
p.001565: (C) AVAILABILITY OF REPORTS.—The Secretary shall make reports submitted under subparagraph (A) available to the
p.001565: public through an Internet website.
p.001565: (D) PENALTIES.—In developing the reporting require- ments under paragraph (1), the Secretary may develop and
p.001565: impose appropriate penalties for non-compliance with such requirements.
p.001565: (E) EXCEPTIONS.—In developing the reporting require- ments under paragraph (1), the Secretary may provide for
p.001565: exceptions to such requirements for group health plans and health insurance issuers that substantially
p.001565: meet the goals of this section.
p.001565: (b) WELLNESS AND PREVENTION PROGRAMS.—For purposes of subsection (a)(1)(D), wellness and health promotion
p.001565: activities may include personalized wellness and prevention services, which are coordinated, maintained or
p.001565: delivered by a health care provider, a wellness and prevention plan manager, or a health, wellness or
p.001565: prevention services organization that conducts health risk assess- ments or offers ongoing face-to-face,
p.001565: telephonic or web-based inter- vention efforts for each of the program’s participants, and which may include
p.001565: the following wellness and prevention efforts:
p.001565: (1) Smoking cessation.
p.001565: (2) Weight management.
p.001565: (3) Stress management.
p.001565: (4) Physical fitness.
p.001565: (5) Nutrition.
p.001565: (6) Heart disease prevention.
p.001565: (7) Healthy lifestyle support.
p.001565: (8) Diabetes prevention.
p.001565: (c) PROTECTION OF SECOND AMENDMENT GUN RIGHTS.—
p.001565: (1) WELLNESS AND PREVENTION PROGRAMS.—A wellness and health promotion activity implemented under
p.001565: subsection (a)(1)(D) may not require the disclosure or collection of any in- formation relating to— ...

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p.001567: 1567
p.001567: PUBLIC HEALTH SERVICE ACT
p.001567: Sec. 2717
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p.001567: January 30, 2020
p.001567: (B) the lawful use, possession, or storage of a firearm or ammunition by an individual.
p.001567: (2) LIMITATION ON DATA COLLECTION.—None of the authori- ties provided to the Secretary under the Patient Protection
p.001567: and Affordable Care Act or an amendment made by that Act shall be construed to authorize or may be
p.001567: used for the collection of any information relating to—
p.001567: (A) the lawful ownership or possession of a firearm or ammunition;
p.001567: (B) the lawful use of a firearm or ammunition; or
p.001567: (C) the lawful storage of a firearm or ammunition.
p.001567: (3) LIMITATION ON DATABASES OR DATA BANKS.—None of the authorities provided to the Secretary under
p.001567: the Patient Protection and Affordable Care Act or an amendment made by that Act shall be construed to authorize
p.001567: or may be used to maintain records of individual ownership or possession of a firearm or ammunition.
p.001567: (4) LIMITATION ON DETERMINATION OF PREMIUM RATES OR ELIGIBILITY FOR HEALTH INSURANCE.—A premium rate may not
p.001567: be increased, health insurance coverage may not be denied, and a discount, rebate, or reward offered for
p.001567: participation in a wellness program may not be reduced or withheld under any health benefit plan issued
p.001567: pursuant to or in accordance with the Patient Protection and Affordable Care Act or an amend- ment made
p.001567: by that Act on the basis of, or on reliance upon—
p.001567: (A) the lawful ownership or possession of a firearm or ammunition; or
p.001567: (B) the lawful use or storage of a firearm or ammuni- tion.
p.001567: (5) LIMITATION ON DATA COLLECTION REQUIREMENTS FOR INDIVIDUALS.—No individual shall be required to
p.001567: disclose any information under any data collection activity authorized under the Patient Protection
p.001567: and Affordable Care Act or an amendment made by that Act relating to—
p.001567: (A) the lawful ownership or possession of a firearm or ammunition; or
p.001567: (B) the lawful use, possession, or storage of a firearm or ammunition.
p.001567: (d) REGULATIONS.—Not later than 2 years after the date of en- actment of the Patient Protection and Affordable Care
p.001567: Act, the Sec- retary shall promulgate regulations that provide criteria for deter- mining whether a reimbursement
p.001567: structure is described in sub- section (a).
p.001567: (e) STUDY AND REPORT.—Not later than 180 days after the date on which regulations are promulgated under
p.001567: subsection (c), the Government Accountability Office shall review such regulations and conduct a study and
p.001567: submit to the Committee on Health, Edu- cation, Labor, and Pensions of the Senate and the Committee on Energy
p.001567: and Commerce of the House of Representatives a report re- garding the impact the activities under this section
p.001567: have had on the quality and cost of health care.
p.001567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001567: Sec. 2718 PUBLIC HEALTH SERVICE ACT 1568
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p.001567: January 30, 2020
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p.001567: SEC. 2718. ø300gg–18¿ BRINGING DOWN THE COST OF HEALTH CARE COVERAGE.
p.001567: (a) CLEAR ACCOUNTING FOR COSTS.—A health insurance issuer offering group or individual health insurance coverage
p.001567: (including a grandfathered health plan) shall, with respect to each plan year, submit to the Secretary a
p.001567: report concerning the ratio of the in- curred loss (or incurred claims) plus the loss adjustment expense
p.001567: (or change in contract reserves) to earned premiums. Such report shall include the percentage of total
p.001567: premium revenue, after ac- counting for collections or receipts for risk adjustment and risk cor- ridors and
p.001567: payments of reinsurance, that such coverage expends—
p.001567: (1) on reimbursement for clinical services provided to en- rollees under such coverage;
p.001567: (2) for activities that improve health care quality; and
p.001567: (3) on all other non-claims costs, including an explanation of the nature of such costs, and excluding Federal
p.001567: and State taxes and licensing or regulatory fees.
p.001567: The Secretary shall make reports received under this section avail- able to the public on the Internet website
p.001567: of the Department of Health and Human Services.
p.001567: (b) ENSURING THAT CONSUMERS RECEIVE VALUE FOR THEIR PREMIUM PAYMENTS.—
p.001567: (1) REQUIREMENT TO PROVIDE VALUE FOR PREMIUM PAY- MENTS.—
p.001567: (A) REQUIREMENT.—Beginning not later than January 1, 2011, a health insurance issuer offering group or indi-
p.001567: vidual health insurance coverage (including a grand- fathered health plan) shall, with respect to each plan
p.001567: year, provide an annual rebate to each enrollee under such cov- erage, on a pro rata basis, if the ratio of the amount
p.001567: of pre- mium revenue expended by the issuer on costs described in paragraphs (1) and (2) of subsection
p.001567: (a) to the total amount of premium revenue (excluding Federal and State taxes and licensing or regulatory
p.001567: fees and after accounting for payments or receipts for risk adjustment, risk cor- ridors, and reinsurance
p.001567: under sections 1341, 1342, and 1343 of the Patient Protection and Affordable Care Act) for the plan year (except as
p.001567: provided in subparagraph (B)(ii)), is less than—
p.001567: (i) with respect to a health insurance issuer offer-
p.001567: ing coverage in the large group market, 85 percent, or such higher percentage as a State may by regulation
p.001567: determine; or
p.001567: (ii) with respect to a health insurance issuer offer- ing coverage in the small group market or in the indi- vidual
p.001567: market, 80 percent, or such higher percentage as a State may by regulation determine, except that the
p.001567: Secretary may adjust such percentage with respect to a State if the Secretary determines that the applica- tion of such
p.001567: 80 percent may destabilize the individual market in such State.
p.001567: (B) REBATE AMOUNT.—
p.001567: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001569: 1569
p.001569: PUBLIC HEALTH SERVICE ACT
p.001569: Sec. 2719
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p.001569: (i) CALCULATION OF AMOUNT.—The total amount of an annual rebate required under this paragraph shall
p.001569: be in an amount equal to the product of—
p.001569: (I) the amount by which the percentage de- scribed in clause (i) or (ii) of subparagraph (A) ex- ceeds the
p.001569: ratio described in such subparagraph; and
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p.001569: January 30, 2020
p.001569: (II) the total amount of premium revenue (ex- cluding Federal and State taxes and licensing or regulatory fees
p.001569: and after accounting for payments or receipts for risk adjustment, risk corridors, and reinsurance under sections
p.001569: 1341, 1342, and 1343 of the Patient Protection and Affordable Care Act) for such plan year.
p.001569: (ii) CALCULATION BASED ON AVERAGE RATIO.—Be- ginning on January 1, 2014, the determination made under
p.001569: subparagraph (A) for the year involved shall be based on the averages of the premiums expended on the costs
p.001569: described in such subparagraph and total premium revenue for each of the previous 3 years for the plan.
p.001569: (2) CONSIDERATION IN SETTING PERCENTAGES.—In deter- mining the percentages under paragraph (1), a State shall
p.001569: seek to ensure adequate participation by health insurance issuers, competition in the health insurance
p.001569: market in the State, and value for consumers so that premiums are used for clinical services and quality
p.001569: improvements.
p.001569: (3) ENFORCEMENT.—The Secretary shall promulgate regu- lations for enforcing the provisions of this section and may
p.001569: pro- vide for appropriate penalties.
p.001569: (c) DEFINITIONS.—Not later than December 31, 2010, and sub- ject to the certification of the Secretary, the
p.001569: National Association of Insurance Commissioners shall establish uniform definitions of the activities reported
p.001569: under subsection (a) and standardized meth- odologies for calculating measures of such activities, including defi-
p.001569: nitions of which activities, and in what regard such activities, con- stitute activities described in subsection
p.001569: (a)(2). Such methodologies shall be designed to take into account the special circumstances of smaller plans, different
p.001569: types of plans, and newer plans.
p.001569: (d) ADJUSTMENTS.—The Secretary may adjust the rates de- scribed in subsection (b) if the Secretary determines
p.001569: appropriate on account of the volatility of the individual market due to the estab- lishment of State Exchanges. ...

p.001601: the end of such period, subject to the second sentence of para- graph (1).
p.001601: (c) PROVISION RELATED TO RISK.—
p.001601: (1) ADOPTION OF NAIC MODELS.—The model act referred to in subsection (a)(1)(D)(i) is the Small Employer and
p.001601: Individual Health Insurance Availability Model Act (adopted by the Na- tional Association of Insurance
p.001601: Commissioners on June 3, 1996) insofar as it applies to individual health insurance cov- erage or the
p.001601: Individual Health Insurance Portability Model Act (also adopted by such Association on such date).
p.001601: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001603: 1603
p.001603: PUBLIC HEALTH SERVICE ACT
p.001603: Sec. 2745
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p.001603: January 30, 2020
p.001603: (2) QUALIFIED HIGH RISK POOL.—For purposes of subsection (a)(1)(D)(ii), a ‘‘qualified high risk pool’’ described in
p.001603: this para- graph is a high risk pool that—
p.001603: (A) provides to all eligible individuals health insurance coverage (or comparable coverage) that does not impose
p.001603: any preexisting condition exclusion with respect to such coverage for all eligible individuals, and
p.001603: (B) provides for premium rates and covered benefits for such coverage consistent with standards included
p.001603: in the NAIC Model Health Plan for Uninsurable Individuals Act (as in effect as of the date of the
p.001603: enactment of this title).
p.001603: (3) OTHER MECHANISMS.—For purposes of subsection (a)(1)(D)(iii), a mechanism described in this paragraph—
p.001603: (A) provides for risk adjustment, risk spreading, or a risk spreading mechanism (among issuers or policies of
p.001603: an issuer) or otherwise provides for some financial subsidiza- tion for eligible individuals, including
p.001603: through assistance to participating issuers; or
p.001603: (B) is a mechanism under which each eligible indi- vidual is provided a choice of all individual health
p.001603: insur- ance coverage otherwise available.
p.001603: SEC. 2745. ø300gg–45¿ RELIEF FOR HIGH RISK POOLS.
p.001603: (a) SEED GRANTS TO STATES.—The Secretary shall provide from the funds appropriated under subsection (d)(1)(A) a
p.001603: grant of up to
p.001603: $1,000,000 to each State that has not created a qualified high risk pool as of the date of enactment of the State High
p.001603: Risk Pool Fund- ing Extension Act of 2006 for the State’s costs of creation and ini- tial operation of such a pool.
p.001603: (b) GRANTS FOR OPERATIONAL LOSSES.—
p.001603: (1) IN GENERAL.—In the case of a State that has estab- lished a qualified high risk pool that—
p.001603: (A) restricts premiums charged under the pool to no more than 200 percent of the premium for
p.001603: applicable standard risk rates;
p.001603: (B) offers a choice of two or more coverage options through the pool; and
p.001603: (C) has in effect a mechanism reasonably designed to ensure continued funding of losses incurred by the State
p.001603: in connection with operation of the pool after the end of the last fiscal year for which a grant is
p.001603: provided under this paragraph;
p.001603: the Secretary shall provide, from the funds appropriated under paragraphs (1)(B)(i) and (2)(A) of subsection (d) and
p.001603: allotted to the State under paragraph (2), a grant for the losses incurred by the State in connection with
p.001603: the operation of the pool.
p.001603: (2) ALLOTMENT.—Subject to paragraph (4), the amounts appropriated under paragraphs (1)(B)(i) and (2)(A)
p.001603: of sub- section (d) for a fiscal year shall be allotted and made available to the States (or the entities
p.001603: that operate the high risk pool under applicable State law) that qualify for a grant under paragraph (1)
p.001603: as follows:
p.001603: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001603: Sec. 2745 PUBLIC HEALTH SERVICE ACT 1604
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p.001603: January 30, 2020
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p.001603: (A) An amount equal to 40 percent of such appro- priated amount for the fiscal year shall be allotted in equal
p.001603: amounts to each qualifying State that is one of the 50 States or the District of Columbia and that
p.001603: applies for a grant under this subsection.
p.001603: (B) An amount equal to 30 percent of such appro- priated amount for the fiscal year shall be allotted among
p.001603: qualifying States that apply for such a grant so that the amount allotted to such a State bears the
p.001603: same ratio to such appropriated amount as the number of uninsured in- dividuals in the State bears to the
p.001603: total number of unin- sured individuals (as determined by the Secretary) in all qualifying States that so
p.001603: apply.
p.001603: (C) An amount equal to 30 percent of such appro- priated amount for the fiscal year shall be allotted among
p.001603: qualifying States that apply for such a grant so that the amount allotted to a State bears the same ratio to
p.001603: such ap- propriated amount as the number of individuals enrolled in health care coverage through the
p.001603: qualified high risk pool of the State bears to the total number of individuals so enrolled through
p.001603: qualified high risk pools (as deter- mined by the Secretary) in all qualifying States that so apply.
p.001603: (3) SPECIAL RULE FOR POOLS CHARGING HIGHER PRE- MIUMS.—In the case of a qualified high risk
p.001603: pool of a State which charges premiums that exceed 150 percent of the pre- mium for applicable standard
p.001603: risks, the State shall use at least 50 percent of the amount of the grant provided to the State to carry out this
p.001603: subsection to reduce premiums for enrollees.
p.001603: (4) LIMITATION FOR TERRITORIES.—In no case shall the ag- gregate amount allotted and made available under
p.001603: paragraph
p.001603: (2) for a fiscal year to States that are not the 50 States or the District of Columbia exceed $1,000,000.
p.001603: (c) BONUS GRANTS FOR SUPPLEMENTAL CONSUMER BENEFITS.—
p.001603: (1) IN GENERAL.—In the case of a State that is one of the 50 States or the District of Columbia,
p.001603: that has established a qualified high risk pool, and that is receiving a grant under subsection (b)(1),
p.001603: the Secretary shall provide, from the funds appropriated under paragraphs (1)(B)(ii) and (2)(B) of sub-
p.001603: section (d) and allotted to the State under paragraph (3), a grant to be used to provide supplemental
p.001603: consumer benefits to enrollees or potential enrollees (or defined subsets of such en- rollees or potential
p.001603: enrollees) in qualified high risk pools. ...

p.001605: remain available for obligation through the end of the following fiscal year.
p.001605: (4) REALLOTMENT.—If, on June 30 of each fiscal year for which funds are appropriated under paragraph
p.001605: (1)(B) or (2), the Secretary determines that all the amounts so appropriated are not allotted or otherwise made
p.001605: available to States, such re- maining amounts shall be allotted and made available under subsection (b) among
p.001605: States receiving grants under subsection
p.001605: (b) for the fiscal year based upon the allotment formula speci- fied in such subsection.
p.001605: (5) NO ENTITLEMENT.—Nothing in this section shall be con- strued as providing a State with an entitlement to a
p.001605: grant under this section.
p.001605: (e) APPLICATIONS.—To be eligible for a grant under this sec- tion, a State shall submit to the
p.001605: Secretary an application at such
p.001605: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001605: Sec. 2751 PUBLIC HEALTH SERVICE ACT 1606
p.001605:
p.001605: time, in such manner, and containing such information as the Sec- retary may require.
p.001605: (f) ANNUAL REPORT.—The Secretary shall submit to Congress an annual report on grants provided under this
p.001605: section. Each such report shall include information on the distribution of such grants among States and the
p.001605: use of grant funds by States.
p.001605: (g) DEFINITIONS.—In this section:
p.001605: (1) QUALIFIED HIGH RISK POOL.—
p.001605: (A) IN GENERAL.—The term ‘‘qualified high risk pool’’ has the meaning given such term in section 2744(c)(2), ex-
p.001605: cept that a State may elect to meet the requirement of subparagraph (A) of such section (insofar as it
p.001605: requires the provision of coverage to all eligible individuals) through providing for the enrollment of eligible
p.001605: individuals through an acceptable alternative mechanism (as defined for pur- poses of section 2744) that
p.001605: includes a high risk pool as a component.
p.001605: (2) STANDARD RISK RATE.—The term ‘‘standard risk rate’’ means a rate—
p.001605: (A) determined under the State high risk pool by con- sidering the premium rates charged by other health insur- ers
p.001605: offering health insurance coverage to individuals in the insurance market served;
p.001605: (B) that is established using reasonable actuarial tech- niques; and
p.001605: (C) that reflects anticipated claims experience and ex- penses for the coverage involved.
p.001605: (3) STATE.—The term ‘‘State’’ means any of the 50 States and the District of Columbia and includes Puerto
p.001605: Rico, the Vir- gin Islands, Guam, American Samoa, and the Northern Mar- iana Islands.
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p.001605: January 30, 2020
p.001605: Subpart 2—Other Requirements
p.001605: SEC. 2751. ø300gg–51¿ STANDARDS RELATING TO BENEFITS FOR MOTH- ERS AND NEWBORNS.
p.001605: (a) IN GENERAL.—The provisions of section 2704 (other than subsections (d) and (f)) shall apply to health
p.001605: insurance coverage of- fered by a health insurance issuer in the individual market in the same manner as it applies to
p.001605: health insurance coverage offered by a health insurance issuer in connection with a group health plan in the
p.001605: small or large group market.
p.001605: (b) NOTICE REQUIREMENT.—A health insurance issuer under this part shall comply with the notice
p.001605: requirement under section 711(d) of the Employee Retirement Income Security Act of 1974 with respect to the
p.001605: requirements referred to in subsection (a) as if such section applied to such issuer and such issuer were a
p.001605: group health plan.
p.001605: (c) PREEMPTION; EXCEPTION FOR HEALTH INSURANCE COVERAGE IN CERTAIN STATES.— ...

p.001619: cov- erage offered through an Exchange and outside of an Ex- change.
p.001619: (B) CONSIDERATION IN OPENING EXCHANGE.—In deter- mining under section 1312(f)(2)(B) of the Patient Protec-
p.001619: tion and Affordable Care Act whether to offer qualified health plans in the large group market through
p.001619: an Ex- change, the State shall take into account any excess of pre- mium growth outside of the Exchange as compared to
p.001619: the rate of such growth inside the Exchange.
p.001619: (c) GRANTS IN SUPPORT OF PROCESS.—
p.001619: (1) PREMIUM REVIEW GRANTS DURING 2010 THROUGH 2014.— The Secretary shall carry out a program to award
p.001619: grants to States during the 5-year period beginning with fiscal year 2010 to assist such States in carrying out
p.001619: subsection (a), including—
p.001619: (A) in reviewing and, if appropriate under State law, approving premium increases for health insurance
p.001619: cov- erage;
p.001619: (B) in providing information and recommendations to the Secretary under subsection (b)(1); and
p.001619: (C) in establishing centers (consistent with subsection (d)) at academic or other nonprofit institutions
p.001619: to collect medical reimbursement information from health insurance issuers, to analyze and organize such
p.001619: information, and to make such information available to such issuers, health care providers, health
p.001619: researchers, health care policy mak- ers, and the general public.
p.001619: (2) FUNDING.—
p.001619: (A) IN GENERAL.—Out of all funds in the Treasury not otherwise appropriated, there are appropriated to the Sec- retary
p.001619: $250,000,000, to be available for expenditure for grants under paragraph (1) and subparagraph (B).
p.001619: (B) FURTHER AVAILABILITY FOR INSURANCE REFORM AND CONSUMER PROTECTION.—If the amounts appropriated
p.001619: under subparagraph (A) are not fully obligated under grants under paragraph (1) by the end of fiscal year
p.001619: 2014, any remaining funds shall remain available to the Sec- retary for grants to States for planning and
p.001619: implementing
p.001619: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001619: Sec. 2794 PUBLIC HEALTH SERVICE ACT 1620
p.001619:
p.001619: the insurance reforms and consumer protections under part A.
p.001619: (C) ALLOCATION.—The Secretary shall establish a for- mula for determining the amount of any grant to a
p.001619: State under this subsection. Under such formula—
p.001619: (i) the Secretary shall consider the number of plans of health insurance coverage offered in each State
p.001619: and the population of the State; and
p.001619: (ii) no State qualifying for a grant under para- graph (1) shall receive less than $1,000,000, or more
p.001619: than $5,000,000 for a grant year.
p.001619: (d) MEDICAL REIMBURSEMENT DATA CENTERS.—
p.001619: (1) FUNCTIONS.—A center established under subsection (c)(1)(C) shall—
p.001619: (A) develop fee schedules and other database tools that fairly and accurately reflect market rates for medical serv-
p.001619: ices and the geographic differences in those rates;
p.001619: (B) use the best available statistical methods and data processing technology to develop such fee schedules and
p.001619: other database tools; ...

p.001679: effectively use certified EHR technology that allows for the electronic ex- change and use of health
p.001679: information, the Secretary, acting through the Office of the National Coordinator, shall establish a
p.001679: health information technology extension program to provide health information technology assistance services to
p.001679: be carried out
p.001679: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001681: PUBLIC HEALTH SERVICE ACT
p.001681: Sec. 3012
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p.001681: through the Department of Health and Human Services. The Na- tional Coordinator shall consult with other
p.001681: Federal agencies with demonstrated experience and expertise in information technology services, such as the
p.001681: National Institute of Standards and Tech- nology, in developing and implementing this program.
p.001681: (b) HEALTH INFORMATION TECHNOLOGY RESEARCH CENTER.—
p.001681: (1) IN GENERAL.—The Secretary shall create a Health In- formation Technology Research Center (in this section
p.001681: referred to as the ‘‘Center’’) to provide technical assistance and develop or recognize best practices to support
p.001681: and accelerate efforts to adopt, implement, and effectively utilize health information technology that
p.001681: allows for the electronic exchange and use of information in compliance with standards, implementation
p.001681: specifications, and certification criteria adopted under section 3004.
p.001681: (2) INPUT.—The Center shall incorporate input from—
p.001681: (A) other Federal agencies with demonstrated experi- ence and expertise in information technology services such
p.001681: as the National Institute of Standards and Technology;
p.001681: (B) users of health information technology, such as providers and their support and clerical staff and
p.001681: others involved in the care and care coordination of patients, from the health care and health information
p.001681: technology indus- try; and
p.001681: (C) others as appropriate.
p.001681: (3) PURPOSES.—The purposes of the Center are to—
p.001681: (A) provide a forum for the exchange of knowledge and experience;
p.001681: (B) accelerate the transfer of lessons learned from ex- isting public and private sector initiatives, including
p.001681: those currently receiving Federal financial support;
p.001681: (C) assemble, analyze, and widely disseminate evi- dence and experience related to the adoption, implementa-
p.001681: tion, and effective use of health information technology that allows for the electronic exchange and use of ...

p.001695: record technology systems.
p.001695: (2) GUIDANCE.—The National Coordinator, in consultation with the Office for Civil Rights of the Department
p.001695: of Health and Human Services, shall issue guidance on common legal, governance, and security barriers
p.001695: that prevent the trusted ex- change of electronic health information.
p.001695: (3) REFERRAL.—The National Coordinator and the Office for Civil Rights of the Department of Health and Human
p.001695: Serv- ices may refer to the Inspector General instances or patterns of refusal to exchange health information
p.001695: with an individual or entity using certified electronic health record technology that is technically capable of
p.001695: trusted exchange and under conditions when exchange is legally permissible.
p.001695: (d) ADDITIONAL PROVISIONS.—
p.001695: (1) INFORMATION SHARING PROVISIONS.—The National Co- ordinator may serve as a technical consultant to the
p.001695: Inspector General and the Federal Trade Commission for purposes of carrying out this section. The National
p.001695: Coordinator may, not- withstanding any other provision of law, share information re- lated to claims or
p.001695: investigations under subsection (b) with the Federal Trade Commission for purposes of such investigations
p.001695: As Amended Through P.L. 116-94, Enacted December 20, 2019
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p.001697: 1697
p.001697: PUBLIC HEALTH SERVICE ACT
p.001697: Sec. 3101
p.001697:
p.001697: and shall share information with the Inspector General, as re- quired by law.
p.001697: (2) PROTECTION FROM DISCLOSURE OF INFORMATION.—Any information that is received by the National Coordinator
p.001697: in connection with a claim or suggestion of possible information blocking and that could reasonably be
p.001697: expected to facilitate identification of the source of the information—
p.001697: (A) shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this
p.001697: section;
p.001697: (B) shall be exempt from mandatory disclosure under section 552 of title 5, United States Code, as
p.001697: provided by subsection (b)(3) of such section; and
p.001697: (C) may be used by the Inspector General or Federal Trade Commission for reporting purposes to the
p.001697: extent that such information could not reasonably be expected to facilitate identification of the source of such
p.001697: information.
p.001697: (3) STANDARDIZED PROCESS.—
p.001697: (A) IN GENERAL.—The National Coordinator shall im- plement a standardized process for the public to submit re-
p.001697: ports on claims of—
p.001697: (i) health information technology products or de- velopers of such products (or other entities offering
p.001697: such products to health care providers) not being interoperable or resulting in information blocking;
p.001697: (ii) actions described in subsection (b)(1) that re- sult in information blocking as described in subsection
p.001697: (a); and
p.001697: (iii) any other act described in subsection (a).
p.001697: (B) COLLECTION OF INFORMATION.—The standardized process implemented under subparagraph (A) shall provide for the
p.001697: collection of such information as the originating in- stitution, location, type of transaction, system and version, ...

p.001709: (vi) Have in place safeguards, consistent with sec- tion 3304(d), to ensure the confidentiality of an indi-
p.001709: vidual’s individually identifiable health information, including requiring that such information not be dis-
p.001709: closed to the individual’s employer without the author- ization of the individual.
p.001709: (vii) Use amounts paid under subsection (c)(1) only for costs incurred in carrying out the
p.001709: activities described in subsection (a), other than those described in subsection (a)(1)(A).
p.001709: (viii) Utilize health care providers with occupa- tional and environmental medicine expertise to con- duct
p.001709: physical and mental health assessments, in ac- cordance with protocols developed under subsection
p.001709: (a)(2)(A)(ii).
p.001709: (ix) Communicate with WTC responders and screening-eligible and certified-eligible WTC survivors in
p.001709: appropriate languages and conduct outreach activi- ties with relevant stakeholder worker or community
p.001709: associations.
p.001709: (x) Meet all the other applicable requirements of this title, including regulations implementing such re-
p.001709: quirements.
p.001709: (C) TRANSITION RULE TO ENSURE CONTINUITY OF CARE.—The WTC Program Administrator shall to the max- imum
p.001709: extent feasible ensure continuity of care in any pe- riod of transition from monitoring and treatment of an
p.001709: en- rolled WTC responder or certified-eligible WTC survivor by a provider to a Clinical Center of Excellence or
p.001709: a health care provider participating in the nationwide network under section 3313.
p.001709: (2) DATA CENTERS.—For purposes of this title, the term ‘‘Data Center’’ means a Center that the WTC Program
p.001709: Admin- istrator determines has the capacity to carry out the respon- sibilities for a Data Center under
p.001709: subsection (a)(2).
p.001709: (3) CORRESPONDING CENTERS.—For purposes of this title, a Clinical Center of Excellence and a Data Center shall be
p.001709: treat- ed as ‘‘corresponding’’ to the extent that such Clinical Center and Data Center serve the same
p.001709: population group.
p.001709: (c) PAYMENT FOR INFRASTRUCTURE COSTS.—
p.001709: (1) IN GENERAL.—The WTC Program Administrator shall reimburse a Clinical Center of Excellence for the
p.001709: fixed infra- structure costs of such Center in carrying out the activities de- scribed in subtitle B at a rate
p.001709: negotiated by the Administrator and such Centers. Such negotiated rate shall be fair and ap-
p.001709: As Amended Through P.L. 116-94, Enacted December 20, 2019
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Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
abuse	Victim of Abuse
access	Access to Social Goods
addicts	addiction
age	Age
alcoholic	alcoholism
alcoholism	alcoholism
armed forces	Soldier
army	Soldier
arrest	person under arrest
authority	Relationship to Authority
belief	Religion
blind	visual impairment
captive	Captive/Exiled Population
caretaker	persons with care obligations
child	Child
child protective services	in child protective services
children	Child
cognitive	Cognitive Impairment
conviction	Religion
crime	Illegal Activity
criminal	criminal
culturally	cultural difference
degenerative	degenerative conditions
dependence	Drug Dependence
dependency	Drug Dependence
dependent	Dependent
detained	person in detention center
diminished	Diminished Autonomy
disability	Mentally Disabled
disabled	Mentally Disabled
drug	Drug Usage
education	education
educational	education
elderly	Elderly
embryo	embryo
emergencies	patients in emergency situations
emergency	Public Emergency
employees	employees
ethnic	Ethnicity
ethnic minority	ethnic minority
ethnicity	Ethnicity
faith	Religion
family	Motherhood/Family
fetus	Fetus/Neonate
fetuses	Fetus/Neonate
foia	Access to information
foreign country	Other Country
gender	gender
hazard	Natural Hazards
hiv/aids	HIV/AIDS
home	Property Ownership
homeless	Homeless Persons
homosexual	LGBTQ+ Status
ill	ill
illegal	Illegal Activity
illness	Physically Disabled
impaired	Cognitive Impairment
impairment	Cognitive Impairment
incapacitated	Incapacitated
incarcerated	Incarcerated
indigenous	Indigenous
infant	Infant
influence	Drug Usage
injured	injured
institutionalized	Institutionalized
investors	investors/intellectual rights
jail	Incarcerated
job	Occupation
language	Linguistic Proficiency
liberty	Incarcerated
linguistic	Linguistic Proficiency
literacy	Literacy
low-income	Economic/Poverty
married	Marital Status
mentally	Mentally Disabled
migrant	migrant
military	Soldier
minor	Youth/Minors
minority	Racial Minority
motherhood	Motherhood/Family
mothers	Mothers
nation	stateless persons
native	Indigenous
occupation	Occupation
officer	Police Officer
opinion	philosophical differences/differences of opinion
orphan	orphan
other country	Other Country
parent	parents
parents	parents
party	political affiliation
physically	Physically Disabled
police	Police Officer
political	political affiliation
poor	Economic/Poverty
poverty	Economic/Poverty
pregnant	Pregnant
prison	Incarcerated
prisoners	Criminal Convictions
property	Property Ownership
race	Racial Minority
racial	Racial Minority
refugee	Refugee Status
religion	Religion
religious	Religion
restricted	Incarcerated
rural area	remote/rural communities
schooling	education
sexually transmitted	sexually transmitted disases
sick	Physically Ill
single	Marital Status
std	sexually transmitted disases
sti	sexually transmitted disases
stigma	Threat of Stigma
student	Student
substance	Drug Usage
substance use	substance use
terminal	Terminally Ill
threat	Threat of Stigma
trauma	Victim of Abuse
underdeveloped	Developing Country
unemployment	Unemployment
union	Trade Union Membership
unlawful	Illegal Activity
unmarried	Marital Status
usage	Drug Usage
victim	Victim of Abuse
violence	Threat of Violence
volunteers	Healthy People
vulnerability	vulnerable
vulnerable	vulnerable
whistleblower	whistleblower
women	Women
youth	Youth/Minors

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
HIV	['hiv/aids']
abuse	['trauma', 'victim']
alcoholic	['alcoholism']
alcoholism	['alcoholic']
armed forces	['army', 'military']
army	['armedXforces', 'military']
belief	['faith', 'conviction', 'religion', 'religious']
child	['children']
children	['child']
cognitive	['impaired', 'impairment']
conviction	['faith', 'belief', 'religion', 'religious']
crime	['illegal', 'unlawful']
dependence	['dependency']
dependency	['dependence']
disability	['disabled', 'mentally']
disabled	['mentally', 'disability']
drug	['influence', 'substance', 'usage']
education	['educational', 'schooling']
educational	['education', 'schooling']
ethnic	['ethnicity']
ethnicity	['ethnic']
faith	['belief', 'conviction', 'religion', 'religious']
family	['motherhood']
fetus	['fetuses']
fetuses	['fetus']
foreign country	['otherXcountry']
hiv/aids	['HIV']
home	['property']
illegal	['crime', 'unlawful']
illness	['physically']
impaired	['cognitive', 'impairment']
impairment	['cognitive', 'impaired']
incarcerated	['jail', 'liberty', 'prison', 'restricted']
indigenous	['native']
influence	['drug', 'substance', 'usage']
jail	['incarcerated', 'liberty', 'prison', 'restricted']
job	['occupation']
language	['linguistic']
liberty	['incarcerated', 'jail', 'prison', 'restricted']
linguistic	['language']
low-income	['poor', 'poverty']
married	['single', 'unmarried']
mentally	['disabled', 'disability']
military	['armedXforces', 'army']
minor	['youth']
minority	['race', 'racial']
motherhood	['family']
native	['indigenous']
occupation	['job']
officer	['police']
other country	['foreignXcountry']
parent	['parents']
parents	['parent']
party	['political']
physically	['illness']
police	['officer']
political	['party']
poor	['poverty', 'low-income']
poverty	['poor', 'low-income']
prison	['incarcerated', 'jail', 'liberty', 'restricted']
property	['home']
race	['minority', 'racial']
racial	['minority', 'race']
religion	['faith', 'belief', 'conviction', 'religious']
religious	['faith', 'belief', 'conviction', 'religion']
restricted	['incarcerated', 'jail', 'liberty', 'prison']
schooling	['education', 'educational']
sexually transmitted	['std', 'sti']
single	['married', 'unmarried']
std	['sexuallyXtransmitted', 'sti']
sti	['sexuallyXtransmitted', 'std']
stigma	['threat']
substance	['drug', 'influence', 'usage']
threat	['stigma']
trauma	['victim', 'abuse']
unlawful	['crime', 'illegal']
unmarried	['married', 'single']
usage	['drug', 'influence', 'substance']
victim	['trauma', 'abuse']
vulnerability	['vulnerable']
vulnerable	['vulnerability']
youth	['minor']

Trigger Words

capacity

consent

cultural

developing

ethics

harm

justice

protect

protection

risk

self-determination

sensitive

volunteer

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Captive/Exiled Population	captive	1
Political	Criminal Convictions	prisoners	5
Political	Illegal Activity	crime	9
Political	Illegal Activity	illegal	7
Political	Illegal Activity	unlawful	7
Political	Indigenous	indigenous	1
Political	Indigenous	native	55
Political	Refugee Status	refugee	1
Political	criminal	criminal	41
Political	migrant	migrant	11
Political	person in detention center	detained	5
Political	person under arrest	arrest	14
Political	political affiliation	party	97
Political	political affiliation	political	187
Political	stateless persons	nation	39
Political	vulnerable	vulnerable	15
Political	vulnerable	vulnerability	1
Health	Cognitive Impairment	cognitive	15
Health	Cognitive Impairment	impaired	6
Health	Cognitive Impairment	impairment	15
Health	Drug Dependence	dependence	7
Health	Drug Dependence	dependency	8
Health	Drug Usage	drug	577
Health	Drug Usage	influence	3
Health	Drug Usage	substance	471
Health	Drug Usage	usage	4
Health	HIV/AIDS	HIV	408
Health	HIV/AIDS	hiv/aids	0
Health	Healthy People	volunteers	10
Health	Mentally Disabled	disabled	12
Health	Mentally Disabled	mentally	8
Health	Mentally Disabled	disability	92
Health	Motherhood/Family	family	304
Health	Motherhood/Family	motherhood	3
Health	Physically Disabled	illness	139
Health	Physically Disabled	physically	5
Health	Physically Ill	sick	2
Health	Pregnant	pregnant	94
Health	Terminally Ill	terminal	1
Health	addiction	addicts	2
Health	alcoholism	alcoholic	5
Health	alcoholism	alcoholism	37
Health	degenerative conditions	degenerative	2
Health	ill	ill	34
Health	injured	injured	11
Health	patients in emergency situations	emergencies	76
Health	sexually transmitted disases	sexually transmitted	16
Health	sexually transmitted disases	std	1
Health	sexually transmitted disases	sti	4
Health	substance use	substance use	146
Health	visual impairment	blind	2
Social	Access to Social Goods	access	343
Social	Access to information	foia	1
Social	Age	age	189
Social	Child	child	314
Social	Child	children	498
Social	Elderly	elderly	26
Social	Ethnicity	ethnic	60
Social	Ethnicity	ethnicity	17
Social	Fetus/Neonate	fetus	11
Social	Fetus/Neonate	fetuses	5
Social	Homeless Persons	homeless	60
Social	Incarcerated	incarcerated	3
Social	Incarcerated	jail	3
Social	Incarcerated	liberty	3
Social	Incarcerated	prison	2
Social	Incarcerated	restricted	12
Social	Infant	infant	58
Social	Institutionalized	institutionalized	1
Social	LGBTQ+ Status	homosexual	4
Social	Linguistic Proficiency	language	44
Social	Linguistic Proficiency	linguistic	15
Social	Literacy	literacy	11
Social	Marital Status	married	1
Social	Marital Status	single	91
Social	Marital Status	unmarried	6
Social	Mothers	mothers	13
Social	Occupation	job	9
Social	Occupation	occupation	1
Social	Police Officer	officer	329
Social	Police Officer	police	7
Social	Property Ownership	home	158
Social	Property Ownership	property	87
Social	Racial Minority	minority	177
Social	Racial Minority	race	20
Social	Racial Minority	racial	71
Social	Religion	faith	18
Social	Religion	belief	8
Social	Religion	conviction	4
Social	Religion	religion	7
Social	Religion	religious	53
Social	Soldier	armed forces	9
Social	Soldier	army	14
Social	Soldier	military	64
Social	Student	student	192
Social	Threat of Stigma	stigma	7
Social	Threat of Stigma	threat	51
Social	Threat of Violence	violence	100
Social	Trade Union Membership	union	1
Social	Unemployment	unemployment	1
Social	Victim of Abuse	trauma	297
Social	Victim of Abuse	victim	36
Social	Victim of Abuse	abuse	445
Social	Women	women	339
Social	Youth/Minors	minor	61
Social	Youth/Minors	youth	119
Social	education	education	859
Social	education	educational	193
Social	education	schooling	1
Social	embryo	embryo	5
Social	employees	employees	224
Social	ethnic minority	ethnic minority	11
Social	gender	gender	12
Social	in child protective services	child protective services	1
Social	orphan	orphan	6
Social	parents	parent	47
Social	parents	parents	82
Social	persons with care obligations	caretaker	2
Social	philosophical differences/differences of opinion	opinion	12
Economic	Economic/Poverty	poor	6
Economic	Economic/Poverty	poverty	56
Economic	Economic/Poverty	low-income	32
Economic	investors/intellectual rights	investors	1
General/Other	Dependent	dependent	60
General/Other	Developing Country	underdeveloped	1
General/Other	Diminished Autonomy	diminished	2
General/Other	Incapacitated	incapacitated	2
General/Other	Natural Hazards	hazard	6
General/Other	Other Country	foreign country	2
General/Other	Other Country	other country	2
General/Other	Public Emergency	emergency	559
General/Other	Relationship to Authority	authority	302
General/Other	cultural difference	culturally	34
General/Other	remote/rural communities	rural area	7
General/Other	whistleblower	whistleblower	3

Public Health Service Act

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Captive/Exiled Population

Political / Criminal Convictions

Political / Illegal Activity

Political / Indigenous

Political / Refugee Status

Political / criminal

Political / migrant

Political / person in detention center

Political / person under arrest

Political / political affiliation

Political / stateless persons

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Dependence

Health / Drug Usage

Health / HIV/AIDS

Health / Healthy People

Health / Mentally Disabled

Health / Motherhood/Family

Health / Physically Disabled

Health / Physically Ill

Health / Pregnant

Health / Terminally Ill

Health / addiction

Health / alcoholism

Health / degenerative conditions

Health / ill

Health / injured

Health / patients in emergency situations

Health / sexually transmitted disases

Health / substance use

Health / visual impairment

Social / Access to Social Goods

Social / Access to information

Social / Age

Social / Child

Social / Elderly

Social / Ethnicity

Social / Fetus/Neonate

Social / Homeless Persons

Social / Incarcerated

Social / Infant

Social / Institutionalized

Social / LGBTQ+ Status

Social / Linguistic Proficiency

Social / Literacy

Social / Marital Status

Social / Mothers

Social / Occupation

Social / Police Officer

Social / Property Ownership

Social / Racial Minority

Social / Religion

Social / Soldier

Social / Student

Social / Threat of Stigma

Social / Threat of Violence

Social / Trade Union Membership

Social / Unemployment

Social / Victim of Abuse

Social / Women

Social / Youth/Minors

Social / education

Social / embryo

Social / employees

Social / ethnic minority

Social / gender

Social / in child protective services

Social / orphan

Social / parents

Social / persons with care obligations

Social / philosophical differences/differences of opinion

Economic / Economic/Poverty

Economic / investors/intellectual rights

General/Other / Dependent

General/Other / Developing Country

General/Other / Diminished Autonomy

General/Other / Incapacitated